UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM | |||||||||||||||||||
(Mark One) EXCHANGE ACT OF 1934 OR ACT OF 1934 For the fiscal year ended OR EXCHANGE ACT OF 1934 For the transition period from __________ to __________ OR EXCHANGE ACT OF 1934 Date of event requiring this shell company report __________ Commission file number | |||||||||||||||||||
(Exact name of registrant as specified in its charter and translation of Registrant’s name into English) The | |||||||||||||||||||
(Jurisdiction of incorporation or organization) | |||||||||||||||||||
(Address of principal executive offices) argenx BV | |||||||||||||||||||
(Name, telephone, e-mail and/or facsimile number and address of company contact person) Securities registered or to be registered pursuant to Section 12(b) of the Act: | |||||||||||||||||||
Title of each class: | Trading | Name of each exchange on which registered: | |||||||||||||||||
Symbol: | |||||||||||||||||||
* Not for trading, but only in connection with the registration of the American Depositary Shares. Securities registered or to be registered pursuant to Section 12(g) of the Act: None. Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None. Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: As of December 31, 2025 Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Yes ☐ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. | |||||||||||||||||||
Accelerated filer ☐ | Non-accelerated filer ☐ | Emerging growth company | |||||||||||||||||
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐ † The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012. Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐ Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing: | |||||||||||||||||||
U.S. GAAP ☐ | by the International Accounting Standards Board ☒ | Other ☐ | |||||||||||||||||
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. Item 17 ☐ Item 18 ☐ If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No (APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS.) Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☐ No ☐ | |||||||||||||||||||
ii |
TABLE OF CONTENTS
Page |
iii |
iv |
Introduction
Unless otherwise indicated, “argenx,” “argenx SE,” “the Company,” “our company,” “we,” “us”, “our” our “Group”
refer to argenx SE and its consolidated subsidiaries.
We own various trademark registrations and applications, and unregistered trademarks, including but not limited to
VYVGART®, VYVGART HYTRULO™, VYVDURA®, ARGENX™, ABDEG™, NHANCE™, SIMPLE
ANTIBODY™, ARGENXMEDHUB™, MG UNITED™, SHINING THROUGH CIDP™, VYVIDLY™ and our
corporate logo. Trade names, trademarks and service marks of other companies appearing in this Annual Report are the
property of their respective holders. Solely for convenience, the trademarks and trade names in this Annual Report may
be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their
respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend to use
or display other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship,
any other companies.
VYVGART® (efgartigimod alfa-fcab) (VYVGART) has been approved in the U.S., Japan, the European Union (the EU)
and several other countries such as the United Kingdom (UK), Switzerland, Israel, mainland China (Mainland China),
Canada, South Korea and United Arab Emirates for the intravenous treatment of generalized myasthenia gravis (gMG).
VYVGART is approved in Japan for the treatment of immune thrombocytopenia (ITP).
VYVGART subcutaneous (SC) (efgartigimod alfa + hyaluronidase qvfc) (VYVGART SC) has been approved in the
U.S. and China as VYVGART HYTRULO™ (VYVGART HYTRULO) and in several other countries, in Japan as
VYVDURA® (VYVDURA) and in the EU and the UK as VYVGART for the treatment of gMG. VYVGART SC has
also been approved in the U.S., China, Japan and the EU for the treatment of chronic inflammatory demyelinating
polyneuropathy (CIDP).
Lastly, VYVGART HYTRULO has also been approved as a prefilled syringe (PFS) in the U.S. for self-injection by
adult patients with gMG and CIDP.
For more information on the approval and commercialization status in several jurisdictions, please refer to “Item 4.B -
Unless otherwise specified, references in this Annual Report to VYVGART should be read as references to VYVGART
and/or VYVGART SC, including VYVGART HYTRULO in relation to the U.S. and China, VYVGART in relation to
the EU and the UK and VYVDURA in relation to Japan, depending on the context.
Our consolidated financial statements are prepared in accordance with the IFRS® Accounting Standards (IFRS) as issued
by the International Accounting Standards Board (IASB).
Our consolidated financial statements are presented in this Annual Report in U.S. dollars. All references in this Annual
Report to “$,” “US$,” “U.S.$,” “U.S. dollars,” “dollars” and “USD” mean U.S. dollars and all references to “€,” “EUR,”
and “euros” mean euros, unless otherwise noted. Throughout this Annual Report, references to ADSs mean American
depositary shares (ADSs) or ordinary shares represented by ADSs, as the case may be.
Cautionary Statement with Respect to Forward-Looking Statements
This Annual Report contains certain forward-looking statements. A forward-looking statement is any statement that does
not relate to historical facts or events or to facts or events as of the date of this Annual Report or that are derived from
our management’s beliefs and assumptions based on information currently available to our management. Forward-
looking statements are generally identified by the use of forward-looking words, such as “aim”, “anticipate”, “aspire”,
“believe”, “can”, “continue”, “could”, “estimate”, “expect”, “entail”, “forecast”, “future”, “goals”, “hope”, “intend”, “is
designed to”, “likely”, “may”, “might”, “objective”, “plan”, “potential”, “pursue”, “project”, “predict”, “seek”, “should”,
“strategy”, “target”, “will” or other or comparable variations or the negative of such terms, or by discussion of strategy,
plans, objectives, goals, future events or intentions, although not all forward-looking statements contain these identifying
words. These statements relate to our future results of operations and financial positions, prospects, developments,
growth, business strategies, plans and our objectives for future operations, results of clinical trials and regulatory
v |
approvals, and are based on analyses or forecasts of future developments and estimates of amounts not yet determinable.
These forward-looking statements represent the view of management only as of the date of this Annual Report, and we
expressly disclaim any obligation or undertaking to update, review or revise forward-looking statements (whether as a
result of new information, future developments or otherwise), except as may be otherwise required by applicable law.
The forward-looking statements in this Annual Report involve known and unknown risks, future events, assumptions,
uncertainties and other factors that could cause our actual future results of operations and financial positions, prospects,
developments, growth, business strategies, plans and our objectives for future operations, results of clinical trials and
regulatory approvals to differ materially from those forecasted or suggested herein.
Forward-looking statements include, but are not limited to, statements about:
•the initiation, timing, progress, development and results of clinical trials of our product candidates, including new
indications, alternative dosing regimens, treatment modalities, and methods of administration, including statements
regarding when results or interim analysis of the clinical trials will be available or made public;
•the expansion of our business, including the further development of our sales and marketing abilities and our IIP, and
the value of our pipeline;
•the potential attributes, benefits, and side effects of our products and product candidates, including new indications,
alternative dosing regimens and treatment modalities, and their competitive position with respect to other alternative
treatments;
•our ability to advance product candidates into, and successfully complete, clinical trials;
•our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that
will enroll in our clinical trials;
•the demand and commercialization of our products and product candidates, including new indications, alternative
dosing regimens, treatment modalities, and methods of administration, if approved;
•the anticipated timing or likelihood of market or regulatory decisions relating to or of our products, including new
indications, alternative dosing regimens, treatment modalities, and methods of administration;
•the anticipated pricing and reimbursement of our products and product candidates, if approved;
•our plans to have various programs to help patients afford our products, including patient assistance and co-pay
coupon programs for eligible patients;
•our ability to establish sales, marketing and distribution capabilities for any of our products and product candidates
that achieve regulatory approval;
•our regulatory strategy and our ability to establish and maintain manufacturing arrangements for our products and
product candidates;
•the scope and duration of protection, including any exclusivity period, we are able to establish and maintain for
intellectual property rights covering our products and product candidates, platform and technology, including our
intention to seek patent term extensions where available;
•our estimates regarding expenses, future revenues, cash flow, capital requirements and our needs for additional
financing;
•our expectation that we will benefit from the Belgian innovation income deduction;
•our financial performance, including potential volatility in the price of our ordinary shares and ADSs;
•the competition we face in our drug discovery, development, and commercialization efforts;
•the rate and degree of market acceptance of our products and product candidates, if approved;
vi |
•the potential benefits of our current collaborations, including the possibility to access partner technology platforms or
capabilities;
•our plans and ability to enter into or maintain current collaborations for additional programs or product candidates;
•our plans and ability to enter into or maintain current new distribution partnerships;
•our long-term growth strategy to develop and market additional products and product candidates, including
efgartigimod for new indications, empasiprubart and adimanebart;
•the impact of government laws and regulations on our business;
•our expectations with respect to the timing and amount of any dividends (if any);
•our plans regarding our supply chain, including our reliance on third parties, including contract manufacturing
organizations (CMOs); and
•our business strategies, including Vision 2030, plans, projects, goals and targets and the timing, outcomes and
benefits thereof.
These include changes in general economic and business conditions. You should refer to ”Item 3.D — Risk Factors” of
this Annual Report for a discussion of important factors that may cause our actual results to differ materially from those
expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the
forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking
statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these
forward-looking statements, you should not regard these statements as a representation or warranty by us or any other
person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to
publicly update any forward-looking statements, whether as a result of new information, future events or otherwise,
except as required by law.
You should read this Annual Report and the documents that we reference in this Annual Report and have filed as
exhibits to the Annual Report completely and with the understanding that our actual future results may be materially
different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
Information regarding market and industry statistics contained in this Annual Report is included based on information
available to us that we believe is accurate. Forecasts and other forward-looking information obtained from this available
information is subject to the same qualifications and the additional uncertainties accompanying any estimates of future
market size, revenue and market acceptance of products and services.
In addition, statements that include “we believe” and similar statements reflect our beliefs and opinions on the relevant
subject. These statements are based upon information available to us as of the date of this Annual Report, and while we
believe such information forms a reasonable basis for such statements, such information may be limited or incomplete,
and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all
potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly
rely upon these statements.
vii |
Summary Risk Factors
Our ability to implement our business strategy is subject to numerous risks that you should be aware of before making an
investment decision. These risks are described more fully below. These risks include, among others:
•The commercial success of our products and product candidates, including in new indications or methods of
administration, will depend on the degree of market acceptance.
•We face significant competition for our drug discovery and development efforts.
•We will face significant challenges in successfully commercializing our products and additional product candidates
after they are launched.
•Our products and product candidates for which we have obtained or intend to seek approval as biological products,
including for new indications, may face biosimilar competition.
•Enacted and future legislation and regulations could impact demand for our products which could impact our business
and future results of operations.
•We are subject to government pricing laws, regulation and enforcement, which affect the prices we may charge the
government for our products and the reimbursement our customers may obtain from the government. Changes in such
laws, regulation, and enforcement may place downward pressure on the prices we can charge in the marketplace, and
our failure to comply with these laws could harm our results, operations and/or financial conditions.
•We may not obtain or maintain adequate pricing and coverage or reimbursement status for our products and product
candidates.
•If we fail to obtain orphan drug designation or we do not have valid and enforceable patents covering our products
and their uses and product candidates and fail to obtain and/or maintain orphan drug exclusivity for our products or
product candidates, our competitors may be able to sell products to treat the same conditions and our revenue may be
reduced.
•Failure to successfully identify, select and develop our products in other indications, or additional products or product
candidates could impair our ability to grow.
•Failure to successfully develop or obtain marketing approval for our products and product candidates could
negatively impact our business.
•Certain of our clinical trials have not succeeded, and may in the future also not succeed, and even if they succeed, we
may not obtain regulatory approval for our products or product candidates or regulatory approval may be delayed.
•If we decide to pursue accelerated approval for any of our product candidates, it may not lead to faster development
or regulatory review or approval and we may still need to conduct additional clinical trials, which could increase the
expense of obtaining, if at all, necessary marketing approvals.
•Our products and product candidates may have serious adverse, undesirable or unacceptable side effects, and we or
others may identify undesirable or unacceptable side effects caused by any of our products or product candidates
before and after they have received marketing approval.
•If our target patient population is smaller than expected, we are unable to successfully enroll and retain patients in our
clinical trials, or experience significant delays in doing so, we may not realize the full commercial potential of any
products or product candidates.
•We rely, and expect to continue to rely, on third parties to conduct some of our research activities, manufacturing and
clinical trials and for parts of the development and commercialization of our existing and future research programs,
products and product candidates. If our relationships with such third parties are not successful, our business may be
adversely affected.
viii |
•Disruptions caused by our reliance on third parties for our raw materials and manufacturing process may delay or
disrupt our business, product development and commercialization efforts.
•Accuracy and timing of our financial reporting is partially dependent on information received from third-party
partners, which we do not control.
•We and our third-party manufacturers and suppliers may become exposed to liability, fines, penalties or other
sanctions and substantial expenses in connection with environmental compliance or remediation activities.
•We are subject to healthcare laws, regulation and potential enforcement. The failure to comply with these laws could
harm our results, operations and/or financial condition.
•Our performance tracked by our Environmental, Social and Governance metrics is subject to risks and the outcomes
may not achieve the anticipated benefits or align with new regulations and stakeholders’ expectations.
•We may not be able to be profitable or sustain net profitability in the future and may require additional financing to
fund our operations.
•We may become exposed to costly and damaging liability claims.
•We may engage in strategic transactions, including acquisitions, collaborations, licenses or investments in other
companies or technologies, and we may not realize the benefits of such transactions.
•Our business and operations could suffer in the event of system failures or unauthorized or inappropriate use of or
access to our systems.
•We may be unable to adequately maintain, enforce or protect our intellectual property rights in products, product
candidates and platform technologies which could adversely affect our ability to maximize the value for patients in
our marketed products and product candidates.
•Intellectual property litigation could lead to substantial resource diversion or issued patents could be found invalid,
not infringed, or unenforceable if challenged in the applicable patent office or court.
•Our future growth and ability to compete depends on maintaining our culture, retaining our key personnel and
recruiting additional qualified personnel.
•Global geo- and socio-political threats and macro-economic uncertainty and other unforeseen political crises could
materially and adversely affect our business and financial performance.
•Holders of our ADSs have fewer rights than our ordinary shareholders.
•The price of our ADSs may be volatile and may fluctuate due to factors beyond our control. An active public trading
market may not be sustained.
•Claims of U.S. civil liabilities may not be enforceable against us or the members of our Senior Management Team
and our Board of Directors.
•As a foreign private issuer, we are exempt from various rules and regulations that a U.S. domestic public company
would be required to follow, including those requirements under U.S. securities laws and Nasdaq listing standards.
•We may lose our foreign private issuer status which would then require us to comply with the Exchange Act’s
domestic reporting regime and cause us to incur significant legal, accounting and other expenses.
•If we were to be classified as a passive foreign investment company for U.S. federal income tax purposes, this could
result in adverse U.S. tax consequences to certain U.S. holders.
1 | ||
PART I
ITEM 1.IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2.OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3.KEY INFORMATION
A.[RESERVED]
B.CAPITALIZATION AND INDEBTEDNESS
Not applicable.
C.REASONS FOR THE OFFER AND USE OF PROCEEDS
Not applicable.
D.RISK FACTORS
Our business faces significant risks, including those described below. You should carefully consider all of the
information set forth in this Annual Report and in our other filings with the SEC, including the following risk factors.
Our business, financial condition or results of operations could be materially and adversely affected if any of these risks
occur. These are not the only risks argenx faces. Additional risks and uncertainties not presently known to argenx or that
it currently considers immaterial or not specific may also impair its business, results of operation and financial condition.
This report also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ
materially and adversely from those anticipated in these forward-looking statements as a result of certain factors
including the risks described below and elsewhere in this Annual Report and as may be described in our subsequent SEC
filings. See “Cautionary Statement with Respect to Forward-Looking Statements”.
Risk Factors Related to Commercialization of argenx’s Products and Product Candidates, Including for New
Indications
The commercial success of our products and product candidates, including in new indications or methods of
administration, will depend on the degree of market acceptance.
Our products and product candidates, including for any new indications or methods of administration, if and when
approved and available on the market, may never achieve an adequate level of acceptance by physicians, patients, the
medical community, or healthcare payors for us to be profitable or sustain net profitability in the future. This will depend
on a number of factors, many of which are beyond our control, including, but not limited to:
•consumer perceptions or publicity regarding our business or the efficacy, safety and quality of the products and
product candidates in our profile, our clinical trials for new indications, or any similar products distributed by other
companies, and the prevalence and severity of any adverse effects discovered before or after marketing approval has
been received;
•approval may be for indications, dosage and methods of administration or patient populations that are not as broad as
intended or desired;
•changes in the standard of care for the targeted indications for any product and product candidate;
•relative availability, cost, and convenience of alternative approved therapies;
•labeling may require significant use or distribution restrictions or safety warnings;
2 | ||
•acceptance by physicians, public health bodies, patients and healthcare payors of each product as safe, effective and
cost-effective; and
•patients continued commitment required to receive periodic in-center infusions.
In addition, because we are developing our products and product candidates for the treatment of different indications,
negative results in a clinical trial evaluating the efficacy and safety of a product or product candidate for one indication,
including by one of our competitors, could negatively impact the perception of the efficacy and safety of such product or
product candidate in a different indication, which could have an adverse effect on our reputation, commercialization
efforts and financial condition.
Moreover, efforts to educate the medical community and third-party payors on the benefits of our products and product
candidates may require significant resources and may never be successful. If our product candidates or methods of use of
existing products or new indications fail to gain market acceptance, it will have a material adverse impact on our ability
to generate revenues. Even if some products achieve market acceptance, they may not be able to retain market
acceptance and/or the market may prove not to be large enough to allow us to generate significant revenues.
We face significant competition for our drug discovery and development efforts.
The market for pharmaceutical products is highly competitive and characterized by rapidly growing understanding of
disease biology, quickly changing technologies, strong intellectual property barriers to entry, and a multitude of
companies involved in the creation, development, and commercialization of novel therapeutics. Many of these
companies are highly sophisticated and often strategically collaborate with each other.
Competition in the autoimmune field is intense and involves multiple mAbs, other biologics and small molecules either
already marketed or in development by many different companies including, but not limited to, large pharmaceutical
companies such as AstraZeneca plc, AbbVie, Inc., Amgen, Inc., Biogen Inc., GlaxoSmithKline plc, F. Hoffman-La
Roche AG, Johnson & Johnson Innovation, Inc. and Novartis AG. In addition, these and other pharmaceutical
companies have mAbs or other biologics in clinical development for the treatment of autoimmune diseases.
Currently, our commercial revenue is generated by VYVGART and VYVGART SC in gMG, CIDP and ITP
(Japan only). We face and expect to continue to face intense competition from other biopharmaceutical companies, who
have launched or are developing products for the treatment of gMG and/or CIDP and other autoimmune diseases,
including products that are in the same class as VYVGART, as well as products that are similar to some of our product
candidates. Competition for other potential future indications is also fierce, with significant development by competitors
in almost all of the indications we are currently developing or planning to develop for our product or product candidates.
For example, we are aware of certain biopharmaceutical companies selling products for the treatment of adult patients
with gMG, and several biopharmaceutical companies are developing drugs that may have utility for the treatment of
gMG and/or CIDP.
Competitive product launches may erode future sales of our products, including our existing products and those currently
under development, or result in unanticipated product obsolescence. Such launches continue to occur, and potentially
competitive products are in various stages of development. We could also face competition for use of limited
international infusion sites, particularly in new markets as competitors launch new products. We cannot predict with
accuracy the timing or impact of the introduction of competitive products that treat diseases and conditions like those
treated by our products or product candidates. In addition, our competitors and potential competitors compete with us in
recruiting and retaining qualified personnel in all areas of our business, establishing clinical trial sites, registering
patients for clinical trials, as well as in acquiring technologies complementary to, or necessary for, the development of
our products.
Competition is also increasing from companies that are utilizing artificial intelligence and other computational
approaches for the development of products. These competitors may incorporate artificial intelligence into their
businesses more quickly or more successfully than us, which could impair our ability to compete effectively and
adversely affect our results of operations. We anticipate that we will continue to face increasing competition in the future
as new companies enter our market and scientific developments surrounding the pharmaceutical market continue to
accelerate. We cannot predict the extent to which these developments will impact potential future sales of our products
or our product candidates. There can be no assurance that our competitors are not currently developing, or will not in the
future develop, technologies and products that are equally or more effective, are more economically attractive, and can
be administered more easily than any of our current or future technologies or products.
Such competing products or technology platforms may gain faster or greater market acceptance than our products or
technology platforms. If we, our products and product candidates or our technology platforms do not compete
effectively, it is likely to have a material adverse effect on our business, financial condition and results of operation.
3
We will face significant challenges in successfully commercializing our products and additional product candidates
after they are launched.
The commercialization of VYVGART in new indications or other product candidates if and when approved, or entrance
of any of our products or product candidates into new markets will require us to further expand our sales and marketing
organization, enter into collaboration arrangements with third parties, outsource certain functions to third parties, or use
some combination of each. We have built, and continue to expand, our sales force in certain of the countries where
VYVGART is approved and plan to further develop our sales and marketing capabilities to promote our products, and
product candidates, including new indications, if and when marketing approval has been obtained in other relevant
jurisdictions.
Even if we successfully expand our sales and marketing capabilities, either on our own or in collaboration with third
parties, we may fail to launch or market our products effectively. Recruiting and training a specialized sales force is
expensive and the costs of expanding an independent sales, marketing and/or promotion organization could be greater
than we anticipate.
We could further encounter difficulties in our sales or marketing, due to regulatory actions, shut-downs, work stoppages
or strikes, approval delays, withdrawals, recalls, penalties, supply disruptions, shortages or stock-outs at our facilities or
third-party facilities that we rely on, reputational harm, the impact to our facilities due to natural or man-made disasters,
product liability, and/or unanticipated costs. In addition, recruiting and training a sales force is time-consuming and
could delay any product launch. In the event that any such launch is delayed or does not occur for any reason, we would
have prematurely or unnecessarily incurred these commercialization expenses, and our investment would be lost if we
cannot retain or reposition our sales and marketing personnel.
Our products and product candidates for which we have obtained or intend to seek approval as biological products,
including for new indications, may face biosimilar competition.
In the U.S., the Biologics Price Competition and Innovation Act (BPCIA) created an abbreviated approval pathway for
biological products that are demonstrated to be “biosimilar” to or interchangeable with a U.S. FDA-licensed reference
biological product. However, during the 12-year regulatory exclusivity period applicable to reference biological
products, another company may still market a competing version of the reference product if the FDA approves a full
BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-
controlled clinical trials of their product.
We believe that any of our product candidates approved as a biological product under a BLA in the U.S. should qualify
for the Biologics Price Competition and Innovation Act 12-year period of exclusivity, as is the case with VYVGART.
The base regulatory exclusivity period for VYVGART is expected to extend until December 2033 in the U.S. whereas
regulatory protection in the EU is expected to expire in August 2032. However, in the U.S., there is a risk that this
exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our product
candidates to be reference products for competing products, potentially creating the opportunity for competition by
biosimilar products sooner than anticipated. The same applies to the EU, as there is also a risk that this exclusivity could
be shortened due to legislative actions.
We are aware that some of our competitors may be actively developing competing or biosimilar products for
VYVGART. It is possible our competitors will be successful in developing biosimilar or interchangeable products for
our products and product candidates, and the approval of such competing products may lead to substantial competition in
the market, a decrease in sales, or force us to make VYVGART available at lower prices due to competitive pressures.
Moreover, an interchangeable biosimilar product, once approved, may be substituted under existing state laws for any
one of our reference products. In addition, the Further Consolidated Appropriations Act, 2020, which incorporated the
framework from the Creating and Restoring Equal Access To Equivalent Samples (CREATES) legislation, allows
biosimilar developers to obtain access to reference biological products, which may facilitate the development of
biosimilars to our products. The FDA has also recently issued guidance eliminating the need for data from comparative
clinical efficiency studies to demonstrate biosimilarity in many circumstances, which may accelerate biosimilar market
entry. If competing or biosimilar products are approved, the market position of our products for existing and recently
approved indications may be adversely affected.
In the EU, biosimilars are evaluated for marketing authorization pursuant to a set of general and product class-specific
guidelines. Moreover, the EU’s legislative bodies are currently working toward finalizing a reform of the EU
Pharmaceutical Legislation, likely shortening the baseline of market exclusivity periods for medicinal products. In
addition, some EU Member States have adopted, or are considering the adoption of, biosimilar uptake measures or may
impose automatic price reductions upon market entry of one or more biosimilar competitors. While the degree of
competitive effects of biosimilar competition among EU Member States may vary, continuation of policies promoting
4 | ||
biosimilar products in the EU and in EU Member States could erode market share or introduce competitive pricing
pressures for our products and product candidates.
Enacted and future legislation and regulations could impact demand for our products which could impact our
business and future results of operations.
In the U.S. and the EU and other jurisdictions, there have been a number of legislative and regulatory changes to
healthcare systems that could affect our future results of operations. Governmental regulations that mandate price
controls or limitations on patient access to our products or establish prices paid by government entities or programs for
our products could impact our business, and our future results of operations could be adversely affected by changes in
such regulations or policies.
In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to
reduce healthcare costs in general and the cost of pharmaceuticals in particular, including pharmaceutical pricing reforms
under the IRA. The IRA authorizes Medicare drug price negotiation, imposes inflation-based rebate obligations and
significantly redesigns the Medicare Part D benefit, including establishing manufacturer discount requirements and
capping beneficiary out-of-pocket costs. Although the program remains subject to legal challenges, the IRA is being
implemented and may materially reduce the prices we are able to charge for our products, increase our rebate and
discount obligations, and affect coverage, formulary placement and demand for our products and product candidates. See
“Item 4.B. — Business Overview — Intellectual property — Regulation — Coverage, Pricing and Reimbursement ” for
additional details.
The HHS has and will continue to issue and update guidance and rulemaking as these IRA programs are implemented.
We cannot predict how the HHS will interpret the IRA in the future, or whether the U.S. Congress will enact legislation
that further amends the law. However, at this time, the Trump administration is continuing to implement the IRA.
Manufacturers that fail to comply with the IRA may be subject to significant penalties, including civil monetary
penalties and excise taxes. The IRA also extends enhanced subsidies for individuals purchasing health insurance
coverage in ACA (as defined below) marketplaces through plan year 2025. To date, none of the legislative attempts to
extend the subsidies has been enacted. While the full economic impact of IRA is unknown at this time, the law’s passage
is likely to affect the pricing of our products and product candidates. The adoption of restrictive price controls in new
jurisdictions, more restrictive controls in existing jurisdictions, the adoption of these lower prices by commercial payors,
or the failure to obtain or maintain timely or adequate pricing could also adversely impact revenue. We expect pricing
pressures will continue globally.
Further, at the U.S. state level, legislatures are increasingly enacting laws and implementing regulations designed to
control pharmaceutical and biological product pricing, including price or reimbursement constraints, discount
requirements, price transparency reporting, and programs designed to encourage importation from other countries and
bulk purchasing. States are also enacting laws modeled on federal policies, such as the IRA and the 340B drug discount
program. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of
which could limit the amounts that federal and state governments will pay for healthcare products and services, including
pharmaceuticals, which could result in reduced demand for our products and product candidates or additional pricing
pressures.
The EU, on the other hand, is in the final stages of adopting new EU Pharmaceutical Legislation in 2026, reforming its
legislative framework for medicinal products (see “Item 3.D — Risk Factors — Agreement on new EU Pharmaceutical
Legislation”).
Depending on the final text, which has yet to be published and is still subject to formal approval, the impact could be
positive with respect to certain regulatory processes. Other aspects may, however, have a negative impact on innovative
pharma and biotech companies such as argenx. In particular, this may be the case for the envisaged shorter baseline
market exclusivity periods. In any case, these legislative changes will only enter into effect after a (not yet specified)
transitional period, which will most likely conclude in 2028 the earliest.
We are subject to government pricing laws, regulation and enforcement, which affect the prices we may charge the
government for our products and the reimbursement our customers may obtain from the government. Changes in
such laws, regulation, and enforcement may place downward pressure on the prices we can charge in the
marketplace, and our failure to comply with these laws could harm our results, operations and/or financial
conditions.
In the U.S., we are required to participate in various government programs for our products to be reimbursed or
purchased by the federal government. We participate in programs such as the Medicaid Drug Rebate Program, the 340B
drug discount program, Medicare Part B, Medicare Part D and the U.S. Department of Veterans Affairs Federal Supply
Schedule pricing program. The requirements vary by program, but we are, among other things, required to enter into
5 | ||
agreements with and calculate and report prices and other information to certain government agencies, charge no more
than statutorily mandated ceiling prices and calculate and pay rebates and refunds for certain products.
The calculations are complex and are often subject to interpretation by us, governmental agencies and the courts. If we
determine that the prices we reported were in error, we may be required to restate those prices and pay additional rebates
or refunds to the extent we understated the rebate or overcharged the government due to the error. Additionally, there are
penalties associated with submission of incorrect pricing or other data by the specified deadline, as well as potential
allegations under the False Claims Act and other laws and regulations.
Statutory or regulatory changes, including changes in CMS guidance, could affect the average sales price calculations
and the resulting Medicare payment rate for VYVGART and our potential future products. Any such measures may
increase our financial obligations to government payors, reduce net realized prices, and adversely affect the demand,
coverage and overall sales of our products. In addition, maintaining compliance with these government price reporting
and discounting obligations is time-consuming and costly, and a failure to comply can result in substantial fines,
penalties, all of which could adversely impact our financial results. See “Item 4.B. — Business Overview — Intellectual
property — Regulation — Coverage, Pricing and Reimbursement” for additional details on the regulatory framework
regarding the coverage, pricing and reimbursement of our products and product candidates.
In addition, the current U.S. Presidential administration has taken several steps to try to align U.S. drug prices with drug
prices in other countries through an approach known as MFN pricing, On November 6, 2025, CMS announced the
GENEROUS Model under its CMMI authority. The GENEROUS Model is a voluntary model that tests the impact of
CMS-facilitated supplemental rebate agreements that align the Medicaid net price with a defined MFN price. In
December 2025, CMS issued proposed rules for the GLOBE Model and the GUARD Model under its CMMI authority.
The GLOBE and GUARD Models are mandatory models that, if finalized, would require manufacturers of certain drugs
to pay additional rebates based on the difference between the Medicare price and the price in market basket countries.
CMS proposes that the new rebate would apply to utilization by approximately 25% of Medicare Part B fee-for-service
beneficiaries and 25% of Medicare Part D enrollees. In Congress, there also are pending legislative proposals that, if
enacted, would require MFN pricing in certain healthcare programs.
It is also currently uncertain how these U.S. policy efforts to align US pharmaceutical pricing more closely to
international benchmarks from countries with competing healthcare cost containment measures will affect our business.
Any expansion, finalization or implementation of these or similar MFN-based pricing initiatives could subject our
products to additional rebate obligations, negatively impact our pricing strategies, product demand, or competitive
positioning across global markets, and may result in reduced revenue in critical markets.
We may not obtain or maintain adequate pricing and coverage or reimbursement status for our products and product
candidates.
Sales of VYVGART and our product candidates, if approved, will depend, in part, on the extent to which third-party
payors, including government health programs in the U.S. (such as Medicare Parts B and D and Medicaid) and other
countries, commercial health insurers, and managed care organizations, provide coverage and establish adequate
reimbursement levels for such products and product candidates. Patients generally rely on third-party payors to
reimburse all or part of the associated healthcare costs, and are unlikely to use our products unless coverage is provided
and reimbursement is adequate to cover a significant portion of the cost of our products.
In the U.S., no uniform policy of coverage and reimbursement for products exists among commercial third-party payors.
Commercial third-party payors decide which products they will pay for and establish reimbursement levels, often relying
upon Medicare coverage policy and payment limitations. However, decisions regarding the extent of coverage,
formulary tier placement, utilization management requirements (including step therapy), and the amount of
reimbursement to be provided for any product candidate that we develop through approval will be made on a plan-by-
plan basis. Even under U.S. government healthcare programs such as Medicare and Medicaid, coverage and
reimbursement policies can vary significantly. Medicare Part D is administered by commercial insurance companies
under contract with the CMS, and their coverage and reimbursement policies may vary, subject to certain statutory and
regulatory requirements. Additionally, Medicaid programs vary from state to state in their coverage policies and
reimbursement rates, subject to certain federal requirements. Further, from time to time, typically on an annual basis,
payment rates are updated and revised by third-party payors. Such updates could impact the demand for our products, to
the extent that patients who are prescribed our products, if approved, are not separately reimbursed for the cost of the
product.
The process for determining whether a third-party payor will provide coverage for a product may be separate from the
process for setting the price of a product or for establishing the reimbursement rate that such a payor will pay for the
product. Even if we do obtain adequate levels of reimbursement, third-party payors, such as government or private
healthcare insurers, carefully review and increasingly question the coverage of, and challenge the prices charged for,
6 | ||
products. Increasingly, third-party payors are requiring that biopharmaceutical companies provide them with
predetermined discounts from list prices and are challenging the prices charged for products. We may also be required to
conduct expensive pharmacoeconomic studies to justify the coverage and the amount of reimbursement for particular
medications. We cannot be sure that coverage and reimbursement will be available for any product that we
commercialize and, if reimbursement is available, what the level of reimbursement will be.
Moreover, coverage policies and third-party payor reimbursement rates may change at any time. Therefore, even if
favorable coverage and reimbursement status is attained for one or more products for which we receive marketing
approval in one or more indications, less favorable coverage policies and reimbursement rates may be implemented in
the future. For instance, even though favorable coverage and reimbursement status has been attained for VYVGART for
the treatment of gMG and CIDP in the U.S., access to VYVGART for any other indication may be reduced or restricted
by limited payor coverage due to treatment criteria, which may prevent us from realizing its full commercial potential. In
addition, the coverage and reimbursement levels for our products for the treatment in one indication may have an adverse
impact on the coverage and reimbursement levels of such products or product candidates in other indications for which
marketing approval has previously been or may subsequently be obtained. Inadequate coverage or reimbursement may
diminish or prevent altogether any significant demand for our products and/or may prevent us entirely from entering
certain markets or indications, which would prevent us from generating significant revenues or sustaining net
profitability in the future, which would adversely affect our business, financials and results of operations.
In many foreign countries, pricing, coverage, and level of reimbursement of prescription drugs are subject to
governmental and/or third-party payor control, and we and our collaborators may be unable to obtain coverage, pricing,
and/or reimbursement on terms that are favorable to us or necessary for us or our collaborators to successfully
commercialize our marketed products in those countries. In some foreign countries, the proposed pricing for a drug must
be approved before it may be lawfully marketed. The requirements governing drug pricing and reimbursement vary
widely from country to country, and may take into account the clinical effectiveness, cost, and service impact of existing,
new, and emerging drugs and treatments. For example, in the EU, pricing and reimbursement of medicinal products, is
almost exclusively a matter for national, rather than EU, provisions and regulations. EU Member States may restrict the
range of medicinal products for which their national health insurance systems provide reimbursement and may control
the prices of medicinal products for human use. An EU Member State may approve a specific price for the medicinal
product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the
medicinal product on the market. Our results of operations may suffer if we or our collaborators are unable to market our
products in foreign countries or if coverage and reimbursement for our marketed products in foreign countries is limited
or delayed. Downward price pressures in the EU and other countries may, in turn, contribute to downward price pressure
in the U.S. because of MFN initiatives.
If we fail to obtain orphan drug designation or we do not have valid and enforceable patents covering our products
and their uses and product candidates and fail to obtain and/or maintain orphan drug exclusivity for our products or
product candidates, our competitors may be able to sell products to treat the same conditions and our revenue may be
reduced.
We have and may from time to time seek orphan drug designation in the U.S., Japan and, the EU for certain indications
addressed by our products and product candidates. With regard to these designations or future designations we may
obtain, we may not be the first to obtain marketing approval of these drugs for such indication due to the uncertainties
associated with developing therapeutic products, and we may not obtain orphan exclusivity upon approval. In the U.S.,
orphan drug exclusivity applies only to the specific uses or indications for which a drug is approved within the
designated rare disease or condition, and therefore may be narrower than the scope of the original orphan designation. In
addition, exclusive marketing rights in the U.S. may be limited if we seek approval for an indication broader than the
orphan-designated indication, or may be lost if the FDA later determines that the request for designation was materially
defective or if we are unable to assure sufficient quantities of the product to meet the needs of patients with the rare
disease or condition. Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not
effectively protect the product from competition because different drugs with different active moieties or different
principal molecular structural features can be approved for the same condition. Even after an orphan drug is approved,
the MHRA, the EMA, respectively the European Commission, the FDA, the MHLW (collectively, the Relevant
Regulatory Authorities) or other comparable regulatory authorities can subsequently approve the same drug with the
same principal molecular structural features for the same condition if the regulator concludes that the later drug is safer,
more effective, or makes a major contribution to patient care.
7
Risk Factors Related to the Development and Clinical Testing of argenx’s Products and Product Candidates
Failure to successfully identify, select and develop our products in other indications, or additional products or
product candidates could impair our ability to grow.
Our long-term growth strategy entails developing and marketing additional products and product candidates, including
efgartigimod for new indications, empasiprubart and adimanebart. This requires substantial resources, whether or not
any product candidates or new indications are ultimately identified. The success of this strategy depends partly upon our
ability to identify, select, develop, and ultimately, commercialize promising product candidates. We are heavily
dependent on precise, accurate and reliable scientific data to identify, select and develop promising product candidates
and products. Our business decisions may therefore be adversely influenced by inaccurate, improper or fraudulent
scientific data, including data sourced from third parties. Even with accurate scientific data, our technology platforms
may fail to discover and to generate additional products and products candidates, that are suitable for further
development.
Even if we identify additional product candidates, they may not be suitable for clinical development as a result of
harmful side effects, limited efficacy or other characteristics that indicate that it is unlikely to be a product that will
receive approval by the Relevant Regulatory Authorities, and other comparable regulatory authorities or achieve market
acceptance. If we do not successfully identify, develop and commercialize product candidates and VYVGART in new
indications based upon our technological approach, we may not be able to obtain product or collaboration revenues in
future periods.
Obtaining regulatory approval for our products and product candidates is inherently uncertain. To obtain the requisite
regulatory approvals to market and sell any of our products and product candidates, we or our collaborators for such
candidates must successfully demonstrate that our products are safe and effective in humans. Clinical trials are expensive
and can take many years to complete, and their outcome is inherently uncertain. Further, success in early clinical trials or
in one indication does not guarantee success in later clinical trials or in other indications.
Failure to successfully develop or obtain marketing approval for our products and product candidates could
negatively impact our business.
The time required to obtain approval by the Relevant Regulatory Authorities and other comparable regulatory authorities
is unpredictable but typically takes many years, if obtained at all, following the commencement of clinical trials and
depends upon numerous factors, including the substantial discretion or interpretation of the regulatory authorities. This
lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain
regulatory approval to market any of our product candidates, including for new indications. We have experienced delays
in our prior clinical trials, and we may experience delays in our ongoing or planned clinical trials, for a large variety of
reasons outside our control in complying with regulatory approvals which can adversely affect the timing of clinical
trials, including as described in “Item 3.D. — Risk Factors — Risk Factors Related to Other Government Regulations —
All aspects of our business ranging from preclinical, clinical trials, marketing and commercialization are highly
regulated and any delay by relevant regulatory authorities could jeopardize our development and approval process or
result in other suspensions, refusals or withdrawal of approvals.”
Over the last several years, the U.S. government has shut down several times and average review times at the FDA have
fluctuated in recent years as a result. If a prolonged government shutdown occurs it could significantly impact the ability
of the FDA to timely review and process our regulatory submissions. Inadequate funding for the FDA and other
government agencies, or other disruptions to these agencies’ operations, could also prevent new products and services
from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing
normal functions on which the operation of our business may rely, which could negatively impact our business.
In addition, ongoing efforts by the current U.S. Presidential administration to limit the size of the FDA and other
agencies of HHS, including through reductions in staff, may further increase the unpredictability in approval timelines
for our products and product candidates. In 2025, HHS announced and implemented a restructuring that included
significant reductions in the FDA’s workforce pursuant to an executive order directing federal workforce optimization.
These staffing reductions together with resignations, resulting in leadership turnover and loss of institutional knowledge,
may disrupt agency operations and adversely affect the timing, consistency or outcome of regulatory review. Ongoing
initiatives by the current U.S. Presidential administration to deregulate and to review the scientific basis for, and
otherwise attempt to influence, FDA decisions and policies create regulatory uncertainty for pharmaceutical companies.
8 | ||
Additionally, uncertainty remains as to how the FDA’s agency-wide implementation of ELSA, a generative artificial
intelligence tool, including for review of drug product applications, as well as its deployment of agentic artificial
intelligence capabilities, will impact the outcomes and timeliness of FDA reviews and other activities. In addition, the
future of the currently applicable Prescription Drug User Fee Act construct to ensure timely FDA review of applications
may be impacted due to expressed concerns about the effect on industry-FDA relations, and staffing shortages.
If we are unable to obtain regulatory approval of our products and product candidates on a timely basis or at all, our
business, financial operations and/or financial condition may be impacted.
Certain of our clinical trials have not succeeded, and may in the future also not succeed, and even if they succeed, we
may not obtain regulatory approval for our products or product candidates or regulatory approval may be delayed.
Certain of our clinical trials have not succeeded, and may in the future also not succeed. We could experience
operational challenges as we undertake an increasing number of clinical trials, including those conducted in countries
outside the EU, UK and the U.S. that may subject us to further delays and expenses as a result of increased shipment
costs, additional regulatory requirements and the engagement of non-EU, non-UK and non-U.S. contract research
organizations (CROs). Such trials may also expose us to risks associated with clinical investigators and institutions who
apply different standards of diagnosis, screening and medical care or are otherwise unfamiliar with standards and
requirements imposed by the Relevant Regulatory Authorities.
If we experience delays in the completion of, or termination of, any clinical trial of our products or product candidates,
may increase our costs, slow down our product candidate development and approval process and jeopardize our ability to
commence product sales and generate revenues. Many of the factors that cause, or lead to, a delay in the commencement
or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates or
result in the development of our product candidates being stopped early. Significant clinical trial delays could also allow
our competitors to bring products to market before we do or shorten any periods during which we have the exclusive
right to commercialize our products and product candidates.
Even if clinical trials are initiated, our development efforts may not be successful. Even if we obtain positive results from
preclinical trials or initial clinical trials, we may not achieve the same success in future clinical trials, which may
negatively impact the price of our ordinary shares or ADSs.
Regulatory approval of our products or product candidates may be delayed or refused for many reasons, including for
reasons outside our control. Some of the reasons for regulatory delay or refusal include:
•the Relevant Regulatory Authorities or other comparable regulatory authorities may disagree with the design or
implementation of our clinical trials;
•we may be unable to demonstrate, to the satisfaction of the Relevant Regulatory Authorities or other comparable
regulatory authorities, that our product candidates are safe, pure, potent and effective for any of their proposed
indications;
•the results of clinical trials may not meet the level of statistical significance required by the Relevant Regulatory
Authorities or other comparable regulatory authorities for approval;
•the chemistry, manufacturing and controls information submitted in an application is insufficient; and
•the facilities of third-party manufacturers with which we contract for the manufacture of our product candidates are
not adequate to support approval of our product candidates.
Any of these occurrences may harm our business, results of operations and financial condition significantly.
If we decide to pursue accelerated approval for any of our product candidates, it may not lead to faster development
or regulatory review or approval and we may still need to conduct additional clinical trials, which could increase the
expense of obtaining, if at all, necessary marketing approvals.
The accelerated approval pathway has come under scrutiny by various stakeholders, and the Food and Drug Omnibus
Reform Act of 2022 (FDORA) revised the requirements for this pathway. Although this legislation did not change the
standard for accelerated approval, it authorized the FDA to require a post-approval clinical trial to be underway prior to
approval or within a specified time period following approval, and must specify conditions of any required post-approval
clinical trial. FDORA also requires sponsors to submit progress reports for required post-approval studies. Failure to
9 | ||
conduct due diligence for required post-approval studies is deemed a prohibited act under the FDCA. FDORA also
details procedures the FDA must follow to withdraw an accelerated approval on an expedited basis, including where the
required post-approval studies are not conducted with due diligence or fail to verify clinical benefit, other evidence
demonstrates that the product is not shown to be safe or effective under the conditions of use, or the sponsor
disseminates false or misleading promotional materials with respect to the product. FDA has been exercising these
authorities and has issued guidance documents regarding the accelerated approval pathway. If we decide to pursue
accelerated approval for any of our product candidates, the failure to obtain accelerated approval (or the withdrawal of
any accelerated approval) could result in a longer time period to commercialization of such product candidate, if any,
and could increase the cost of development of such product candidate and harm our competitive position in the
marketplace. For example, if standard of care were to evolve or if any of our competitors were to receive approval for a
drug or biological product for a disease or condition for which we are seeking accelerated approval before we receive
accelerated approval, we may not be able to demonstrate that our product candidate provides a meaningful advantage
over other available therapies and accelerated approval may not occur.
Our products and product candidates may have adverse, undesirable or unacceptable side effects, and we or others
may identify undesirable or unacceptable side effects caused by any of our products or product candidates before and
after they have received marketing approval.
Undesirable side effects that may be caused by our product candidates, or by the combination of our product candidates
with other medical products, could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could
result in more restrictive labeling or the delay or denial of regulatory approval by the Relevant Regulatory Authorities or
other comparable regulatory authorities. We have observed adverse events and treatment emergent adverse events in our
clinical trials, and we may see additional adverse events and treatment emergent adverse events in our ongoing and
future clinical trials. Such side effects may be more serious than those observed to date, and as a result, our ongoing and
future clinical trials may be negatively impacted. Moreover, as we seek to develop product candidates, including
products in new indications, patients may experience new or more serious effects. Drug-related side effects caused by
any of our products or product candidates that we or others identify could, among other things, affect patient recruitment,
the ability of enrolled patients to complete the clinical trial, result in potential product liability claims, damage sales of
our existing products, result in significant reputational damage for us and our product development, and other issues
including the delay of other programs.
Any undesirable drug-related side effects can also cause the Relevant Regulatory Authorities or other comparable
regulatory authorities to withdraw approvals or revoke licenses of such products and require us to take such products off
the market, require the addition of labeling statements, specific warnings, or a contraindication or other modification of
the product labeling, request the issuance of safety alerts, require a REMS to ensure that the benefits of the product
outweigh its risks, and/or require us to change the way the product is administered, conduct additional clinical trials or
change the labeling of the product.
If our target patient population is smaller than expected, we are unable to successfully enroll and retain patients in
our clinical trials, or experience significant delays in doing so, we may not realize the full commercial potential of
any products or product candidates.
Currently, we mainly develop products or product candidates for the treatment of rare diseases for which the target
patient population can be small. If the actual number of patients with these disorders is smaller than we expected, we
may encounter difficulties in enrolling sufficient patients in our clinical trials, thereby delaying or preventing
development and approval of our products or product candidates. Physicians, who are an important source of patients for
clinical trials, may also be less familiar with these rare diseases and may therefore fail to identify these conditions in
their patients and therefore may not refer them to our clinical trials.
Patient enrollment, a significant factor in the timing of clinical trials, depends on many factors, including the size and
nature of the patient population, eligibility criteria for the clinical trial, the proximity of patients to clinical sites,
competition for patient recruitment from competing clinical trials, the design of the clinical trial, the availability of
alternate approved therapies for the indication the clinical trial is investigating, and clinicians’ and patients’ perceptions
as to the potential advantages of the drug being studied in relation to other available therapies. We compete with other
companies to enroll target patient populations, as set forth in “Item 3.D. Risk Factors — Risk Factors Related to
Commercialization of argenx’s Products and Product Candidates, Including for New Indications—We face significant
competition for our drug discovery and development efforts.” Even if product candidates obtain significant market share
for their approved indications, because certain potential target populations are small, we may never recoup our
investment in such product candidate without obtaining regulatory approval for additional indications for such product
candidates.
Even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our clinical trials. In
addition, any negative results we may report in clinical trials of our drug candidates may make it difficult or impossible
to recruit and retain patients in other clinical trials of that same drug candidate. Delays in the completion of any clinical
10 | ||
trial of our product candidates will increase our costs, slow down our product candidate development and approval
process and delay or potentially jeopardize our ability to commence product sales and generate revenue. In addition,
some of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also
ultimately lead to the denial of regulatory approval of our product candidates.
Risk Factors Related to argenx’s Dependence on Third Parties
We rely, and expect to continue to rely, on third parties to conduct some of our research activities, manufacturing and
clinical trials and for parts of the development and commercialization of our existing and future research programs,
products and product candidates. If our relationships with such third parties are not successful, our business may be
adversely affected.
We have relied upon and plan to continue to rely upon third parties, including independent clinical investigators, CROs,
CMOs and other third-party service providers with the applicable protocol, legal and regulatory requirements and
scientific standards, and our reliance on these third parties does not relieve us of our regulatory responsibilities. To the
extent our collaborators or the CROs or investigators fail to enroll participants for our clinical trials, fail to conduct the
clinical trial to GCP standards or in full compliance with legal and regulatory requirements or are delayed for a
significant time in the execution of clinical trials, including achieving full enrollment, we may be affected by increased
costs, program delays or both, which may harm our business.
In addition, we are, and expect to continue to be, dependent on partnerships with partners and licensees relating to the
development and commercialization of our existing and future research programs, products and product candidates. We
currently have collaborative research relationships with various pharmaceutical companies such as AbbVie, Zai Lab and
with various academic and research institutions worldwide for the development of product candidates resulting from
such collaborations. We also have distribution agreements in place with several distribution partners for VYVGART. We
have and will continue to have discussions on potential partnering opportunities with various pharmaceutical companies.
If we fail to enter into or maintain collaborations on reasonable terms or at all, our ability to develop our existing or
future research programs and product candidates and to commercialize our existing or future products could be delayed,
the commercial potential of our products could change and our costs of development and commercialization could
increase.
While we have agreements governing our relationships with these third parties, we have limited influence over their
actual performance and control only certain aspects of their activities. If independent investigators, third-party service
providers or CROs fail to devote sufficient resources to the development of our product candidates, or if their
performance is substandard, it may delay or compromise the prospects for approval and commercialization of any
product candidates that we develop. In addition, our collaborators, CROs, CMOs, distributors, and other third-party
service providers are subject to extensive healthcare, regulatory, data privacy, manufacturing, anti-corruption and other
laws and regulations. Although we seek to structure our relationships in compliance with applicable laws and regulations
and monitor the activities of these third parties, we do not control their day-to-day operations and cannot guarantee that
they will comply with all applicable legal and regulatory requirements. Any failure by our third-party partners to comply
with such requirements could result in regulatory enforcement actions, monetary penalties, exclusion from government
healthcare programs, reputational harm, delays in development or commercialization, or other adverse consequences. In
particular, regulatory authorities enforce GCP requirements through periodic inspections of clinical trial sponsors,
principal investigators and clinical trial sites. If we, our investigators or any of our CROs fail to comply with applicable
GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the Relevant Regulatory Authorities
or comparable regulatory authorities may require us to perform additional clinical trials before approving our marketing
applications. In addition, our collaborative partners may not adhere to, or may terminate collaboration agreements with,
all associated consequences or disagree on the interpretation of contractual terms. We may not be able to control our
collaborative partners’ compliance with all applicable requirements for the commercialization of our products, which
could adversely affect such commercialization and the profitability of such products. Failures by our collaborative
partners to meet their contractual, regulatory, or other obligations to us, or any disruption in the relationships between us
and our collaborative partners, could have a material adverse effect on our product pipeline and business.
We face significant competition in establishing successful relationships with third-party service providers and
appropriate collaborative partners. These third-party service providers may have contractual relationships with other
entities, some of which may be our competitors, which may draw their time and resources away from our programs. In
addition, some of our third-party service providers or CROs have the ability to terminate their respective agreements
with us, and if such agreements terminate, we may not be able to enter into arrangements with alternative CROs or
investigators or to do so on commercially reasonable terms. In addition, we may not be able to find appropriate
collaboration partners.
Disruptions caused by our reliance on third parties for our raw materials and manufacturing process may delay or
disrupt our business, product development and commercialization efforts.
11 | ||
We do not have the ability to internally source the raw materials necessary to produce our products or product
candidates, and do not currently have, nor do we plan to acquire, the infrastructure or capability internally to
manufacture our products or product candidates and depend on a worldwide supply chain and third parties for both.
Disruptions caused by our reliance on such third-party suppliers, service providers and manufacturers may delay or
disrupt our business, product development and commercialization efforts.
Reliance on Third-Party Suppliers and Service Providers
For some of our raw materials, we rely on a single source of supply and there are limited supplies of the raw materials. If
prices increased, or we were to experience an unexpected loss of supply of or if any supplier was unable to meet our
demand for any of our products and product candidates, including increased demand if VYVGART is approved for
additional indications, we could experience delays in our research or planned clinical trials or risk shortages in
commercial supply which could materially impact our revenue potential. These issues could be exacerbated by pressure
on the supply chain, for example due to power shortages, natural disasters, extreme weather conditions, public health
crises, changed laws or regulations, military conflicts, executive orders, or geopolitical events, including trade disputes,
embargoes or economic or financial sanctions enacted as a result of international conflict. The cost of our raw materials
may also increase based on actual or threatened trade restrictions or increased tariffs on foreign exports. As we continue
to grow our business we may need to establish additional sources of supply for our products. The lead time needed to
establish a relationship with a new supplier can be lengthy and require us to devote substantial time and resources, which
could result in additional costs, or delays and adversely affect our business.
Additionally, certain of the raw materials required in the manufacture and the formulation of our products and product
candidates may be derived from biological sources, including mammalian tissues, bovine serum and human serum
albumin. There are certain European regulatory restrictions on using these biological source materials including rigorous
testing requirements, which could limit or delay production. Regulatory authorities may require additional studies if we
adopt a new supplier. If there are changes in the regulation requirements that our suppliers are unable to meet, our
clinical development or commercial activities may be delayed or interrupted.
We may not be able to engage a back-up or alternative supplier or service provider in a timely manner or at all if any of
these third parties were to cease or interrupt production or otherwise fail to supply these materials, products, or services
to us for any reasons, including due to regulatory requirements or actions (including recalls), adverse financial
developments at or affecting the supplier, failure by the supplier to comply with cGMPs, contamination, business
interruptions, or labor shortages or disputes. Interruptions in the supply of these materials, products or services may also
result from international conflict, trade disputes, embargoes or economic or financial sanctions imposed, administered or
enforced by the UN Security Council, the U.S., the UK, the EU, or the respective governmental institutions of any of the
foregoing including, without limitation, the Office of Foreign Assets Control of the US Department of the Treasury, the
US Department of Commerce, the US Department of State and any other agency of the US government.
Reliance on Third-Party Manufacturing
We rely on and expect to continue to rely on CMOs. We also rely on certain third parties to perform filling, finishing,
distribution, laboratory testing and other services related to the manufacture and supply of our products and product
candidates.
We do not control the manufacturing process at our CMOs and are completely dependent on them for the production of
our products and product candidates in accordance with relevant regulations (such as cGMPs), although we are
responsible for ensuring that our products comply with regulatory requirements. If our CMOs cannot successfully
manufacture material that conforms to our specifications and the strict regulatory requirements of the Relevant
Regulatory Authorities or other comparable regulatory authorities, our business could be adversely affected, including an
inability to initiate or continue clinical trials of product candidates under development, delay in submitting regulatory
applications, or receiving regulatory approvals for product candidates, including new indications, subjecting third-party
manufacturing facilities to additional inspections by regulatory authorities, requirements to cease distribution or to recall
batches of our products or product candidates and an inability to meet commercial demands for our marketed products.
Most notably, we contract with Lonza for their manufacturing sites in Slough, UK, Portsmouth, U.S., Singapore and
Visp, Switzerland as well as with Fujifilm, based in Denmark, for activities relating to the development of cell banks,
development of our manufacturing processes and the manufacturing of drug substance. We use additional contract
manufacturers to fill, test, label, package, store and distribute our (investigational) drug products. Our products and
product candidates are biologics and require multiple processing steps that are more difficult than those required for most
small molecule chemical pharmaceuticals. While we work with our CMOs and partners on optimization, strengthening
and upscaling our manufacturing, problems with these manufacturing processes, such as capacity issues, or even minor
deviations from the normal process or from the materials used in the manufacturing process, which may not be
detectable by us in a timely manner, could lead to manufacturing failures or product defects, resulting in lot failures,
product recalls, product liability claims and insufficient inventory.
12 | ||
We face risks inherent in relying on limited CMOs, as any failure in their ability to successfully manufacture our
products or product candidates as described above or any disruption, such as supply shortages or disruptions of raw
materials, fires, pandemics, natural hazards or acts of vandalism at the CMO could significantly interrupt our
manufacturing capability. Alternative production plans in place or disaster-recovery facilities available to us may not be
sufficient. In case of a disruption, we may have to establish additional alternative manufacturing sources. This would
require substantial investment on our part, which we may not be able to obtain on commercially acceptable terms or at
all. Additionally, we may experience significant manufacturing delays as we build or locate replacement facilities and
seek and obtain necessary regulatory approvals. If this occurs, we will be unable to satisfy manufacturing needs on a
timely basis, if at all. Also, operating any new facilities may be more expensive than operating at our current facilities.
Further, business interruption insurance may not adequately compensate us for any losses that may occur, and we would
have to bear the additional cost of any disruption. For these reasons, a significant disruptive event of the manufacturing
facility could have drastic consequences, including placing our financial stability at risk.
Accuracy and timing of our financial reporting is partially dependent on information received from third-party
partners, which we do not control.
We have collaborated, and plan to continue to collaborate, with third parties, including distributor and licensing partners,
on certain product candidates. As part of some of these collaborations, our collaboration partners are responsible for
providing us with financial information regarding specific projects, including funds spent, liabilities incurred and
expected future costs, on which we rely for our own financial reporting. If our collaboration partners fail to provide us
with the necessary financial information within the agreed upon timeframes, or if such financial information proves
inaccurate, it would adversely impact the timing and accuracy of our own financial reporting. Any inaccuracy in our
financial reporting could cause investors to lose confidence in our financial reporting, reputational damage or affect our
ability to obtain, and the terms of, any future financing, which may harm our business.
Risk Factors Related to Other Government Regulations
We are subject to healthcare laws, regulation and enforcement. The failure to comply with these laws could harm our
results, operations and/or financial condition.
Our current and future operations are and may become directly, or indirectly through our customers and third-party
payors, subject to various U.S. federal and state, EU and EU Member State, Japanese, Chinese, UK, Canadian and Israeli
healthcare laws, and healthcare laws of other jurisdictions in which we conduct our business. This includes, but is not
limited to, the U.S. FDCA, the U.S. False Claims Act and EU Directive 2001/83/EC.
In particular, our sales, marketing and business arrangements are subject to healthcare fraud and abuse, anti-kickback
and similar laws designed to prevent fraud, misconduct, improper inducements and other abusive practices. For example,
EU Directive 2001/83/EC restricts the provision of gifts, pecuniary advantages or other benefits to persons qualified to
prescribe or supply medicinal products, subject to limited exceptions. Compliance with these complex and evolving
requirements requires significant resources and may constrain our commercial activities.
Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur
significant legal expenses and divert our management’s attention from the operation of our business.
The shifting compliance environment and the need to maintain robust and expandable systems to comply with multiple
jurisdictions with different compliance or reporting requirements increases the possibility that we or our collaborative
partners may run afoul of one or more of these requirements. We continue to expand, enhance and refine our internal
ethics and compliance function and program to ensure compliance with the different healthcare laws and regulations. As
we continue to grow our headcount to support our business, we face increased compliance risk as we need to train and
supervise additional personnel to comply with relevant healthcare laws and regulations. This involves substantial costs
and, notwithstanding our investment, there can be no assurance that our policies and procedures will be followed at all
times or will effectively detect and/or prevent all compliance violations by our employees, consultants, subcontractors,
agents and partners.
It is possible that governmental authorities will conclude that our business practices do not comply with current or future
statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our
operations are found to be in violation of any of these laws or any other governmental regulations applicable to us, we
may be subject to significant civil, criminal and administrative investigations, penalties, damages, fines, disgorgement,
imprisonment, exclusion of drugs from government funded healthcare programs, such as Medicare and Medicaid in the
U.S., additional reporting requirements and oversight, reputational harm and the curtailment or restructuring of our
operations. Managing such investigations and defending against or appealing any such actions or penalties can be costly
and time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful
in managing any such governmental investigations and/or defending against or appealing any such actions or penalties
that may be brought against or imposed upon us, our business may be impaired. Efforts to ensure that our business
13 | ||
arrangements with third parties comply with applicable healthcare laws and regulations also involve substantial costs,
and because we do not fully control the operations or compliance practices of these third parties, we cannot assure you
that they will comply with all applicable healthcare laws and regulatory requirements.
The scope, interpretation and enforcement of healthcare laws remain uncertain and subject to change, particularly in the
current environment of healthcare reform. Federal and state authorities in the U.S. have increased scrutiny of interactions
between healthcare companies and healthcare providers, as well as promotional practices, including direct-to-consumer
prescription drug advertising and manufacturer-sponsored platforms that facilitate patient access to products. The FDA
has also heightened its review of the data supporting advertising and promotional claims. Compliance with these
evolving requirements, and responding to investigations or enforcement actions, may require significant time and
resources and could divert management attention, result in penalties or otherwise adversely affect our business.
All aspects of our business, including preclinical research, clinical trials, marketing and commercialization, are
highly regulated, and any delay by relevant regulatory authorities could jeopardize our development and approval
process and/or result in suspensions of marketing authorizations, refusals to approve our products, or withdrawal of
existing approvals.
Before we can commence clinical trials for a product candidate, we must complete extensive preclinical testing to
support our IND or planned IND applications in the U.S. or Japan, or our clinical trial applications (CTAs) in the EU, or
comparable applications in other jurisdictions. We cannot be sure that we will be able to submit INDs or CTAs or
comparable applications for our development programs on the timelines we expect, if at all. We also cannot guarantee
that submission of INDs or CTAs or comparable applications will result in the Relevant Regulatory Authorities or other
regulatory authorities allowing clinical trials to begin.
Clinical trials must be conducted in accordance with applicable laws and regulations, Relevant Regulatory Authorities'
and other comparable regulatory authorities’ legal requirements and regulations and are subject to oversight by Relevant
Regulatory Authorities and other comparable regulatory authorities as well as IRBs and ethics committees. In particular,
clinical trials must be conducted in compliance with GCPs and clinical supplies of our products and product candidates
must be produced under cGMPs and other regulations. We could encounter delays if a clinical trial is suspended or
terminated, by us, by the IRB or ethics committee, by the data review committee or data safety monitoring board for
such clinical trial, or by the Relevant Regulatory Authorities or other comparable regulatory authorities. Such authorities
may impose a suspension or termination due to a number of factors, including failure to conduct the clinical trial in
accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or clinical
trial site by the Relevant Regulatory Authorities or other comparable regulatory authorities resulting in the imposition of
a clinical hold, unforeseen safety issues or adverse side effects, including those relating to the class to which our
products and product candidates belong, failure to demonstrate a benefit from using the product or product candidate,
changes in governmental regulations or administrative actions, or lack of adequate funding to continue the clinical trial.
If we experience delays in the completion of, or termination of, any clinical trial of our products or product candidates,
the costs of our clinical programs may increase, the commercial prospects of our products and product candidates may be
harmed, and our ability to generate product revenues from any of these products and product candidates may be delayed.
Significant clinical trial delays could also allow our competitors to bring products to market before we do, or shorten any
periods during which we have the exclusive right to commercialize our products and product candidates.
Moreover, we must obtain separate regulatory approvals in each jurisdiction where we want to market, and approval by
one regulatory authority does not ensure approval by any other regulatory authority. As approval procedures can vary
among countries and may change over time, this can require additional clinical testing, and the time required to obtain
approval may differ. We can provide no assurances that such approval will be obtained on the timeline that we expect or
at all. In addition, we anticipate submitting applications for approval of VYVGART in new indications, but can provide
no assurances that such applications will be accepted or that we will receive approval on our anticipated timeline, or at
all.
If VYVGART or any new formulations of VYVGART are not approved in one or more jurisdictions including beyond
the countries where VYVGART is approved, or if such approvals are significantly delayed, it could have a material
adverse effect on our business. It is possible that none of our other existing product candidates or any product candidates
we may seek to develop in the future will ever obtain regulatory approval in any other jurisdiction for any indication.
Even if approval is obtained, the Relevant Regulatory Authorities or other comparable regulatory authorities may
approve the product for fewer or more limited indications or patient sub-segments than requested and/or with a label that
does not include the labeling claims necessary or desirable for the successful commercialization of that product. Further,
the Relevant Regulatory Authorities or other comparable regulatory authorities may impose extensive and ongoing
unique regulatory requirements, such as granting approval contingent on the performance of costly post-marketing
clinical trials, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product.
14 | ||
The costs of compliance with all Relevant Regulatory Authorities' and other applicable authorities' regulations,
requirements or guidelines could be substantial, and failure to comply could result in sanctions, including fines,
injunctions, civil penalties, denial of applications for marketing authorization of our products, delays, suspension or
withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal
prosecutions, any of which could significantly increase our and/or our collaborative partners’ costs or delay or prevent
the development and commercialization of our product candidates. At this time, we cannot guarantee or know the exact
nature, precise timing and detailed costs of the efforts that will be necessary to complete the remainder of the
development of our research programs and product candidates.
We are subject to privacy, cybersecurity and AI laws, regulation and potential enforcement. The failure to comply
with these laws could harm our results, operations and/or financial conditions.
Privacy laws, regulations and related enforcement are particularly relevant to our business as we collect, store and
process personal data and in particular data of vulnerable groups such as patients, and sensitive information including
health data as well as human biological samples. We also collaborate with third parties where we may seek to use data
collected by third parties on our or their behalf, or we may seek to share data collected by us with such third parties to
further our research or commercial initiatives.
The GDPR imposes strict requirements, including access controls, impact assessment and safeguards on cross-border
transfers of personal data and imposes substantial penalties in the event of non-compliance. We face uncertainty as to the
exact interpretation of the requirements under the GDPR, and we may be unsuccessful in implementing all measures
required by data protection authorities or courts. Any investigation by a data protection authority could result in fines
and other penalties.
The data privacy landscape is complex and fragmented. In the EU, national laws may impose stricter obligations than
the GDPR, particularly for sensitive genetic, ethnic origin or race data, while regulations like the Directive 2002/58/EC
of the European Parliament and of the Council of July 12, 2002 (as amended, the
e-Privacy Directive) add further compliance risks.
This trend expands globally, with evolving laws in countries such as the U.S., Japan, Canada and China. For example,
China has passed a number of laws concerning data protection and the collection, use and transfer of personal data
(including data considered to be relevant as Chinese human genetic resources), and restricting the transfer of this data
outside of China. These evolving laws and regulations impose increasing restrictions on the processing of personal data,
which may require us to modify our data collection or processing practices and to incur significant expenses associated
with our compliance efforts.
Moreover, in the current digital and regulatory landscape, privacy obligations are increasingly interconnected with
broader cybersecurity laws and requirements, reflecting the close link between the protection of personal data and the
security of information systems. Failure to comply with applicable cybersecurity frameworks and directives, including
Directive (EU) 2022/2555 on Network and Information Security (NIS2), could result in significant legal, regulatory, and
operational risks. In addition, inadequate cybersecurity and non-compliance with data protection laws and regulations
increases the risk of personal data breaches, potentially resulting in regulatory sanctions, civil claims, reputational
damage and loss of trust.
Furthermore, our integration of AI solutions into certain of aspects our business, introduce a new layer of regulatory risk.
Most significantly, Regulation (EU) 2024/1689 (AI Act) establishes the world’s first comprehensive legal framework for
AI, impacting how we develop and deploy AI systems in the future. In particular, high-risk AI systems must comply
with strict regulatory requirements to ensure safety, transparency, and fundamental rights protection. Non-compliance
with the AI Act may result in significant penalties. As most provisions will take effect from August 2, 2026, we must
continuously assess and adapt our compliance strategy to mitigate risks from this evolving legal landscape.
If we violate existing laws and regulations or fail to comply with changing laws and regulations, we might be subject to
fines, penalties and other adverse consequences, which could have a material adverse effect on our reputation, business,
results of operations, cash flows or financial condition.
Failure to comply with anti-corruption laws and regulations, anti-money laundering laws and regulations, economic
or financial sanctions, trade embargoes and/or export control regulations and other laws governing our operations
could have an adverse impact on our business, financial conditions and operations.
We are or may become subject to various laws and regulations regarding anti-corruption, anti-money laundering,
economic or financial sanctions, trade embargoes, investment restrictions, anti-fraud, other comprehensive prohibitions
against transaction activity pursuant to anti-terrorism laws or export control laws and regulations issued by multiple
jurisdictions. These include the UK Bribery Act 2010 and the U.S. Foreign Corrupt Practices Act of 1977, in each case,
15 | ||
as amended, as well as comparable laws and regulations in other countries in which we do business, including in the
European Union and China, which prohibit, among other things, payments, offers, or promises made for the purpose of
improperly influencing any act or decision of a foreign government official. In the UK, since September 1, 2025, it is an
offense under the Economic Crime and Corporate Transparency Act 2023 for a large organization to fail to prevent
certain fraudulent activities by an associated person (such as an employee, agent, or subsidiary), unless it can
demonstrate that it had reasonable prevention procedures in place to prevent the fraudulent activity. The nature of our
business means that we engage in significant interactions with foreign officials. Compliance with these laws and
regulations in the U.S. and in foreign jurisdictions is complex, and may increase our cost of doing business
internationally.
We are also subject to economic and financial sanctions, trade embargoes, other comprehensive prohibitions against
transaction activity pursuant to anti-terrorism laws and export control rules and regulations, including those imposed,
administered or enforced by the UN Security Council, the, U.S., the UK, and the EU. Any change in export or import
regulations, economic or financial sanctions regulations, trade embargo regulations or related legislation, shift in the
enforcement or scope of existing regulations, or change in the countries, governments, persons or technologies targeted
by such regulations, could decrease our ability to conduct our planned research and development activities and to
manufacture, import, export or sell our products internationally, which could require us to expend additional resources to
achieve our goals and adversely affect our business, financial conditions and operations.
We have mechanisms in place to promote compliance with such rules and regulations. However, there can be no
assurance that our policies and procedures will be followed at all times or will effectively detect and/or prevent
violations of applicable compliance regimes by our employees, consultants, sub-contractors, agents and partners. In the
event of non-compliance, we could be subject to substantial civil or criminal penalties, including sanctions against us,
incarceration for responsible employees and managers, the possible loss of export or import privileges, debarment from
participation in government contracting, reputational harm, and resulting loss of revenue and profits, which could have a
material adverse impact on our business, financial conditions and operations.
Our performance tracked by our Environmental, Social and Governance metrics is subject to risks and the outcomes
may not achieve the anticipated benefits or align with new regulations and stakeholders’ expectations.
There has been an increasing focus from stakeholders and regulators relating to environmental, social and governance
(ESG) matters across all industries in recent years. The standards and stakeholder expectations continue to evolve,
sometimes with contradictory expectations, and criteria to evaluate ESG practices may change rapidly. We are subject to
evolving rules, including the European Union’s Corporate Sustainability Reporting Directive (CSRD) and ancillary
European Union legislation. The SEC adopted rules in 2024 requiring enhanced climate-related disclosures, but after
legal challenges, subsequently announced that it would end its defense of such climate disclosure rule. As a result,
various U.S. states have enacted or proposed climate- and sustainability-related disclosure laws that may apply to
companies doing business in those jurisdictions, such as California’s climate and carbon market disclosure laws, which
would require in-scope companies to report on greenhouse gas emissions, climate-related financial risks, and the use of
carbon offsets and emissions reduction claims relating to their operations or products. The future of the California
climate disclosure laws is uncertain, as these laws are subject to ongoing litigation.
In response to new ESG initiatives and regulations we may voluntarily elect, or be required, to adopt strategies, policies,
or procedures related to ESG matters. Such efforts could divert management’s attention from central operational matters
and cause us to expend significant capital and human resources. Moreover, increasingly, different stakeholder groups
and regulators have divergent views, particularly in the U.S., on ESG matters, which increases the risk that any action or
lack thereof with respect to sustainability or ESG matters will be perceived negatively by at least some stakeholders and
regulators and adversely impact our business and reputation. The current sociopolitical landscape has led to rapid and
unpredictable shifts in public sentiment, which has resulted in dynamics that increase the risk of reputational damage,
boycotts and shifts in consumer behavior that could adversely affect our business and reputation. Reports could also lead
to the disclosure of information that may have a negative impact on our operations and reputation which may lead to
additional exposure. In addition,
any required disclosures and measurements of ESG metrics are highly dependent on third-parties, such as our suppliers
and CROs, that we do not control. Failure to accurately comply with any sustainability reporting obligations may result
in enforcement actions, sanctions, fines and penalties, reputational harm or private litigation.
We may become exposed to liability and substantial expenses in connection with environmental compliance or
remediation activities.
Our operations, including our research, development and testing, and our third-party manufacturers’ and suppliers’
operations, are subject to numerous environmental, health and safety laws and regulations and for which we may become
liable. These laws and regulations govern, among other things, the controlled use, handling, release and disposal of and
the maintenance of a registry for, hazardous materials and biological materials, laboratory procedures and exposure to
16 | ||
pathogens. We do not have control over our manufacturers’ or suppliers’ compliance with environmental, health and
safety laws and regulations.
If we or one of our CMOs or third-party distributors, manufacturers, suppliers, licensees or co-marketers fail to comply
with such laws and regulations, such failure could result in substantial liability, fines, penalties or other sanctions and
incur substantial expenses, and could also face significant reputational loss.
We face a risk of environmental liability inherent in our current and historical activities, including liability relating to
releases of our exposure to hazardous or biological materials. Furthermore, environmental, health and safety laws and
regulations are becoming more stringent. Both us and our third-party manufacturers and suppliers may be required to
incur substantial expenses in connection with future environmental compliance or remediation activities, in which case,
our production and development efforts may be interrupted or delayed, and our financial condition and results of
operations may be materially adversely affected.
Risk Factors Related to argenx’s Financial Position
We may not be able to be profitable or sustain net profitability in the future and may require additional financing to
fund our operations.
To be profitable or sustain net profitability in the future, we must continue to succeed in commercializing products that
generate significant product net sales. Our future results of operations and profitability may fluctuate from period to
period, and we will need to generate significant revenues to be profitable or sustain net profitability in the future. We
may not be able to generate these revenues, and we may never achieve profitability on a sustained basis in the future. If
we do not succeed in sustaining profitability or in funding our operations, we would not be able to use deferred tax assets
against taxable profits which would result in a de-recognition of our deferred tax asset balance.
In addition, we intend to continue to conduct research and development, preclinical testing, clinical trials and regulatory
compliance activities as well as the continued commercialization of VYVGART and other products candidates, for
current and future indications, and we intend to continue our efforts to expand our sales, marketing and distribution
infrastructure. As a result, we anticipate that our operating expenses will increase as we execute on our strategic
objectives and could increase more significantly if we experience delays or encounter issues relating thereto, including
failed clinical trials, ambiguous clinical trial results, safety issues or other regulatory challenges.
To finance our operations, particularly if we are unable to generate sufficient product net sales or otherwise control
expenses, we may need to raise additional capital through a combination of public or private equity or debt financings or
other sources, which may include collaborations with third parties. Our ability to raise additional funds on acceptable
terms or at all will depend on financial, economic and market conditions and other factors, over which we may have no
or limited control. If we cannot raise additional capital when needed on acceptable terms, we may be required to delay,
reduce or terminate research and development programs; defer or forego commercialization of our products and product
candidates (including for new indications); and limit expansion or otherwise fail to capitalize on business opportunities,
any of which could have a material adverse effect on our business, financial condition and results of operations.
Our assets, earnings and cash flows and the investment of our cash and cash equivalents may be subject to risks
which may cause losses and affect the liquidity of these investments.
We invest our cash in accordance with an established internal investment policy. Currently, substantially all of our
available cash and cash equivalents and current financial assets are invested in either current accounts, savings accounts,
term accounts or highly liquid money market funds. Any future investments may include term deposits, corporate bonds,
commercial paper, certificates of deposit, government securities and money market funds in accordance with our cash
investment policy. These investments may be subject to general credit, liquidity, market, inflation, foreign currency and
interest rate risks and we may realize losses in the fair value of these investments or a complete loss of these
investments. The aforementioned risks associated with our cash flows and investment portfolio may adversely affect our
results of operations, liquidity and financial condition.
Due to the international scope of our operations, our assets, earnings and cash flows are influenced by movements in
exchange rates of several currencies, particularly the euro and Japanese Yen, versus the U.S. dollar. Our revenue from
outside of the U.S. will increase as our products, whether commercialized by us or our business partners or our
collaborators gain marketing approval in such jurisdictions. If the U.S. dollar weakens against a specific foreign
currency, our revenues will increase, having a positive impact on net income, but our overall expenses will increase,
having a negative impact on expenses. Conversely, if the U.S. dollar strengthens against a specific foreign currency, our
revenues will decrease, having a negative impact on net income, but our overall expenses will decrease, having a positive
impact on expenses. Continued volatility in foreign exchange rates is likely to impact our operating results and financial
condition.
17
Risk Factors Related to argenx’s Business and Industry
We may become exposed to costly and damaging liability claims.
We are exposed to potential product liability and professional indemnity risks that are inherent in the research,
development, manufacturing, marketing and use of pharmaceutical products and marketing of human therapeutic
products. The current and future use of products and product candidates by us and our collaborators in clinical trials and
the sale of any approved products may further expose us to liability claims. If any of our products or product candidates
were to cause adverse side effects during clinical trials or after approval of the product candidate, we may be exposed to
substantial liabilities. These claims might be made by patients who use the product, healthcare providers, pharmaceutical
companies, physicians, payors, caregivers, investors, employees, government agencies, or our collaborators or others
selling such products. Physicians and patients may not comply with any warnings that identify known potential adverse
effects and patients who should not use our product candidates. Any claims against us, regardless of their merit, could be
difficult and costly to defend and could materially adversely affect the market for our products and product candidates or
any prospects for commercialization of our products and product candidates. Any such claims, regardless of their merit,
could also adversely affect our reputation and the trust that physician and patients place in our products.
Product liability risk in the EU will increase in the future once plaintiff-friendly reforms, such as Directive (EU)
2024/2853 (the new Product Liability Directive), take effect. The new Product Liability Directive introduces claimant-
friendly changes. This includes, for instance, the expansion of the definition of “damage” (e.g. by including medically
recognized psychological harm), creating rebuttable presumptions as to defect and causation to help claimants prove
their case (e.g. if the claimant faces excessive difficulties to prove this due to scientific complexity) and abolishing
minimum or maximum financial thresholds for claims. The new Product Liability Directive, like its predecessor,
provides that claims shall expire if the injured person does not initiate proceedings within ten years after the defective
product was placed on the market. However, it extends this long stop period (a statute of limitations) to 25 years if this is
due to the latency of the underlying personal injury. Member States must transpose the Product Liability Directive into
national law by December 2026.
Regardless of the merits or eventual outcome, litigation or liability claims may result in:
•decreased demand for our products due to negative public perception;
•damage to our reputation;
•withdrawal of clinical trial participants or difficulties in recruiting new clinical trial participants;
•initiation of investigations by regulators;
•costs to defend or settle the related litigation;
•a diversion of management’s time and our resources;
•substantial monetary awards to clinical trial participants or patients;
•product recalls, withdrawals or labeling, marketing or promotional restrictions;
•loss of revenues from product sales; and
•the inability to successfully commercialize our product candidates, if approved.
Although we maintain product liability insurance, we may not be able to maintain insurance coverage at a reasonable
cost or to obtain adequate insurance coverage to satisfy any liability that may arise. Product liability claims could delay
or prevent completion of our clinical development programs. In addition, claims made by patients, healthcare
professionals or others might not be fully covered by product liability insurance and could result in investigations of the
safety of our products or product candidates or may result in recalls. If a successful product liability claim or series of
claims is brought against us for uninsured liabilities or in excess of insured liabilities, our assets may not be sufficient to
cover such claims and our business, financial condition and results of operations would be adversely affected.
In the ordinary course of business we may also face substantial, complex or extended litigation that could cause us to
incur significant costs and distract our management. This is especially relevant for biopharmaceutical companies. Such
litigation or proceedings could substantially increase our operating expenses and could adversely affect our business.
18
We may engage in strategic transactions, including acquisitions, collaborations, licenses or investments in other
companies or technologies, and we may not realize the benefits of such transactions.
We may enter into strategic transactions, including acquisitions, collaborations, licenses or investments for or in other
companies or technologies that complement or augment our existing business and facilitate our access to new products,
research projects or geographical areas. However, we may not be able to identify appropriate targets or enter into such
transactions under satisfactory conditions. We may be unable to complete a proposed transaction if we or our
shareholders are unable to obtain required regulatory approvals in the various jurisdictions in which we or a potential
acquisition target or acquirer operate. In addition, we may need additional funding to finance these transactions including
through issuances of public or private equity or convertible debt securities, which could be dilutive to our shareholders
and ADS holders.
Integrating any newly acquired companies, business, technologies or products could be expensive, time-consuming, and
may never be successful. Integration efforts often take a significant amount of time, place a significant strain on
managerial, operational and financial resources, result in loss of key personnel and could prove to be more difficult or
expensive than we predict. The diversion of our management’s attention and any delay or difficulties encountered in
connection with any future transactions we may consummate could result in the disruption of our ongoing business or
inconsistencies in standards and controls that could negatively affect our ability to maintain third-party relationships. We
cannot assure that we will achieve the expected synergies to justify any such transaction, which could have a material
adverse effect on our business, financial condition, results of operations and future growth prospects and our investors’
ability to realize on their investment.
Our business and operations could suffer in the event of system failures or unauthorized or inappropriate use of or
access to our systems.
We are increasingly dependent on our and our third-party partners’ information technology systems and infrastructure
for our business. We collect, store and transmit sensitive information including intellectual property, proprietary business
information, including highly sensitive clinical trial data, and personal data in connection with business operations. The
secure maintenance of this information is critical to our operations and business strategy. Some of this information could
be an attractive target of criminal attack or unauthorized access and use by third parties with a wide range of motives and
expertise, including organized criminal groups, “hacktivists”, patient groups, disgruntled current or former employees
and others. Cyber-attacks are of ever-increasing levels of sophistication, and despite our security measures, our
information technology and infrastructure may be vulnerable to such attacks or may be breached, including due to
employee error or malfeasance.
In addition to these threats, we are subject to stringent cybersecurity laws, most notably NIS2 with respect to our
activities in the European Union. As a company involved in the development and manufacturing of pharmaceutical and
medicinal products, our operations could be brought within the scope of NIS2. This would require us to implement
robust measures to secure our network and information systems. We are also subject to cybersecurity laws in other
international jurisdictions in which we conduct our operations, such as the Cybersecurity Review Measures in China.
Failure to comply with these cybersecurity standards could result in significant penalties. See ”Item 3.D. Risk Factors—
Risk Factors Related to Other Government Regulations—We are subject to privacy, cybersecurity and AI laws,
regulation and potential enforcement. The failure to comply with these laws could harm our results, operations and/or
financial conditions.”
Although we are making significant efforts to maintain the security and integrity of our information systems and the
information systems of our third-party partners and are exploring various measures to manage the risk of a security
breach or disruption, there can be no assurance that our security efforts and measures will be effective or that attempted
security breaches or disruptions would not be successful or damaging. Despite the implementation of security measures,
our internal computer systems and those of our third-party partners, contractors and consultants are vulnerable to damage
or interruption from computer viruses, unauthorized or inappropriate access or use, natural disasters, pandemics,
terrorism, war (including the ongoing conflict in Ukraine and conflict in the Middle East), and telecommunication and
electrical failures. For example, the loss of pre-clinical trial data or data from completed or ongoing clinical trials for our
product candidates could result in delays in our regulatory filings and development efforts, as well as delays in the
commercialization of our products, and significantly increase our costs. To the extent that any disruption, security breach
or unauthorized or inappropriate use or access to our systems were to result in a loss of or damage to our data, or
inappropriate disclosure of confidential, personal or proprietary information, we could incur notification obligations to
affected individuals and government agencies, liability, including potential lawsuits from patients, collaborators,
employees, stockholders or other third parties and liability under foreign, federal and state laws that protect the privacy
and security of personal data, and the development and potential commercialization of our product candidates could be
delayed. Disruptions in the our and our third-party partners’ information technology systems could adversely affect our
business operations and harm our competitive position.
19 | ||
Not all of our contracts contain limitations of liability, and even where they do, there can be no assurance that limitations
of liability in our contracts are sufficient to protect us from liabilities, damages or claims related to our data privacy and
security obligations. We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to
mitigate liabilities arising out of our privacy and security practices.
Risk Factors Related to argenx’s Intellectual Property
We may be unable to adequately maintain, enforce or protect our intellectual property rights in products, product
candidates and platform technologies which could adversely affect our ability to maximize the value for patients in
our marketed products and product candidates.
Our commercial success depends in part on obtaining and maintaining patents and other forms of intellectual property
rights for our products, product candidates and platform technologies. Failure to obtain, maintain, enforce, protect, or
extend adequate patent and other intellectual property rights, which can be challenging and costly, could adversely affect
our ability to develop and market our products and product candidates and reduce any competitive advantage we may
have.
We cannot be certain that patents will be issued or granted with respect to applications that are currently pending and we
may not be the first to file patent applications related to our product candidates and products. The scope of patent
protection that the European Patent Office and the USPTO will grant with respect to products in our product pipeline is
uncertain and may vary. It is possible that the European Patent Office and USPTO will not allow broad claims that cover
molecules closely related to our products and product candidates as well as the specific molecule, and competitors may
be free to market substantially similar molecules if granted approval, thereby reducing our market potential. We and our
current or future licensors, licensees or collaboration partners may not be able to prepare, file, prosecute and maintain all
necessary or desirable patent applications at a reasonable cost or in a timely manner. Our current and future licensors’,
licensees’ or collaboration partners’ ability to ensure the issuance, scope, validity, enforceability and commercial value
of technology licenses is uncertain and we may need to rely on them to obtain costly additional IP licenses. Additionally,
such parties may not fully comply with applicable patent rules or laws, which could result in loss of patent rights, or such
parties may disagree with us as to the strategy for prosecution, maintenance or enforcement of any such patent rights.
Filing, prosecuting, and defending patents on product candidates in all jurisdictions throughout the world would be
prohibitively expensive and the laws of certain jurisdictions may not protect our rights to the same extent as the laws of
the U.S., UK or EU. We may face difficulties in enforcing patent rights in the future, including in certain jurisdictions
where we have not yet filed patent applications.
Competitors may use our and our licensors’ or collaboration partners’ technologies in jurisdictions where we have not
obtained patent protection, or where broad research exemptions are available, to develop their own products. Third
parties may export otherwise infringing products to territories where we, our licensors or collaboration partners have
patent protection, but where enforcement is not as strong as that in the U.S., UK and the EU. In such cases, we would
have little effective recourse to prevent such products from competing with ours.
In addition, some countries have compulsory licensing laws under which a patent owner may be compelled to grant
licenses to third parties, and other countries limit the enforceability of patents against government agencies or
government contractors. In these countries, the patent owner may have limited remedies, which could materially
diminish the value of such patent.
Intellectual property litigation could lead to substantial resource diversion or issued patents could be found invalid,
not infringed, or unenforceable if challenged in the applicable patent office or court.
Our patents may remain open to invalidity challenges after allowance or grant, whereby third parties can challenge the
scope or validity of such granted patent. In the course of such proceedings, we may be compelled to limit the scope of
patent claims thus challenged or may lose the claims altogether.
We may elect to initiate adversarial proceedings in order to enforce or defend any intellectual property rights owned by
or licensed to us, or to determine or challenge the scope or validity of intellectual property rights of third parties to
protect our competitive position. We may need to divert substantial time and resources to the enforcement and protection
of our or our collaboration partners’ intellectual property rights. In addition, the outcomes of any proceedings could be
uncertain and any remedies or damages awarded may not be meaningful. An adverse ruling of non-infringement,
limiting claim scope, or invalidating one or more of our issued patents could allow third parties to commercialize our
products after the expiration of our market exclusivity or use our platform technologies to compete directly with us,
without payment to us.
20 | ||
In many jurisdictions (including the Unified Patent Court), an action to enforce a patent may not be brought until
immediately before, or even after, the infringing product of a competitor has been launched in the market. In these
jurisdictions, infringement rulings and injunctions (even in preliminary injunction proceedings) are often issued only
after the competing product has already been launched and potentially impaired the competitive advantage on the
market.
We may be subject to claims challenging the inventorship or ownership of our intellectual property or be required to
make additional payments to secure intellectual property from collaborators.
Many of our consultants and employees, including in the senior management team (consisting of our CEO and senior
personnel reporting directly to the CEO) (Senior Management Team), were previously employed at other competing or
potentially competing biotechnology or pharmaceutical companies and some have executed proprietary rights, non-
disclosure and non-competition agreements in connection with such previous employment. Although we take measures
to ensure third parties, consultants and employees do not use such proprietary information in their work for us, we may
be subject to claims that we or these consultants and employees have improperly used or disclosed confidential
information or intellectual property of their former employer.
Additionally, many of our collaborators do not commit to assigning all intellectual property arising out of our
collaborations to us and, instead, grant us options to acquire intellectual property or commit to making such intellectual
property available to us at a fair price. As such, we may be required to make additional payments to secure valuable
intellectual property rights under our existing collaborations or become subject to inventorship disputes.
In addition, although we take steps to ensure that our collaborators do not use our intellectual property rights other than
for the purposes of our collaboration, there may be instances where former or current collaborators or other third parties
nevertheless apply for or obtain patent protection for inventions to which we believe we have rights, in whole or in part.
In such cases, we may elect to assert our ownership of such intellectual property. There is no guarantee that we will be
successful in asserting such claims.
In addition, while it is our policy to require our employees and contractors who may be involved in the development of
intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in
ensuring effective assignment of intellectual property under such agreements. Our assignment agreements may not be
self-executing, or may be breached, and we may be forced to bring or defend against claims to assert ownership of such
intellectual property. There is no guarantee we will be successful in pursuing such claims, which could result in us
paying monetary damages or losing valuable personnel or intellectual property rights.
Third-party intellectual property rights could adversely affect our ability to commercialize our products and product
candidates.
Our revenue generated may suffer if valid and enforceable third-party intellectual property rights cover our products,
product candidates, manufacturing processes, or those of our partners. In such cases, our freedom to develop or
commercialize products or product candidates may require obtaining a license, designing around third party intellectual
property rights with significant time and materials costs, or invalidating the third party rights. If our products are found
to infringe a valid and enforceable patent claim, we and our partners could be prevented from continuing to develop or
commercialize the affected product without an appropriate license, which may be costly or unavailable on commercially
reasonable terms, if at all. Similarly, other companies may have filed patent applications or have patents directed toward
molecules and/or uses of those molecules that modulate similar targets modulated by our products and we may not be
aware of unpublished pending patent applications or patent applications that are amended to cover our products or
platform technologies.
Even if we or our partners can obtain the appropriate license, it may be non-exclusive, thereby providing third parties
with the opportunity to access the same licensed technology. If the breadth and scope of protection provided by our or
our partners’ patents, licensed patents, or patent applications is threatened or limited, it could dissuade companies from
future collaborations with us to license, develop, or commercialize products and product candidates which would have
an adverse effect on our business position.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation,
some of our confidential information could be disclosed in any such proceedings.
We may not be successful in obtaining or maintaining necessary rights to our products and product candidates
through acquisitions and in-licenses.
We may be unable to acquire or in-license third-party intellectual property rights necessary or useful for development or
commercialization of our product, product candidates or technology. We sometimes collaborate with U.S. and non-U.S.
21 | ||
academic institutions and typically receive an option to negotiate a license to the institution’s proprietary interest in any
collaboration technology. However, we may be unable to successfully negotiate such license and the institution may
offer such intellectual property rights to third parties thereby devaluing our exclusive rights to pursue the applicable
program.
In addition, our competitor companies may be unwilling to license desirable or necessary intellectual property rights to
us, or we may be otherwise unable to license or acquire other third party intellectual property rights on commercially
reasonable terms which could negatively impact current development or hinder our ability to pursue development of new
programs.
Under our existing licenses, failure to comply with our obligations thereunder could result in termination of such
licenses, thereby limiting our ability to develop and commercialize products covered by such licensed technology.
Moreover, despite our efforts to comply with our contractual obligations, our licensors could conclude we have
materially breached any such agreement and we could incur significant costs and disruption to our business defending
against any breach alleged by the licensor.
Moreover, several of our existing license agreements are sub-licenses from third parties. We have little control if our
licensors fail to comply with their obligations under their upstream license agreements, whereby the original third-party
licensor may have the right to terminate the original license and possibly our sub-license. In such cases, we may not be
able to procure a direct license covering such intellectual property possibly materially affecting our ability to develop
and commercialize certain products and product candidates.
If our brand protection strategies, including the filing, prosecution and enforcement of trademarks and trade names,
are not adequately executed, we may not be able to build name recognition for approved products in our markets of
interest in line with our strategic priorities.
Third parties may seek to oppose, attempt to cancel our trademark applications, or challenge, infringe or circumvent our
registered and unregistered trademarks, including through counterfeiting of our products. In the event that our
trademarks are successfully challenged, we may not be able to use these trademarks to continue to effectively market our
branded products and could be forced to rebrand them, which could result in loss of their brand recognition or require us
to devote resources to develop new brand profiles. Such efforts could also hinder our efforts to commit to and deliver on
strategic internal initiatives.
If we attempt to enforce our trademarks or assert trademark infringement claims, a court may determine that our
trademarks are invalid or unenforceable or that the party against whom we have asserted trademark infringement has
superior rights with respect to such marks. If we are unable to establish name recognition and adequately protect and
enforce our trademark portfolio, we may not be able to compete effectively in the market or build brand recognition for
new products globally.
We may not be able to obtain protection under the U.S. Drug Price Competition and Patent Term Restoration Act of
1984 (Hatch-Waxman Act) and similar non-U.S. legislation for extending the term of patents covering each of our
products and product candidates.
Depending upon the timing, duration and conditions of FDA marketing approval of our product candidates, one or more
of our U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act and similar
legislation in the EU and the Asia Pacific region. However, the patent term extension under the Hatch Waxman Act
cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only one
patent applicable to an approved drug may be extended.
If we are unable to obtain patent term extension, the term of any such extension is less than we request, or the statutes
governing patent term extension are amended to reduce the term of such extensions, our patent exclusivity for that
product will be shortened and our competitors may obtain approval to market competing products sooner than we expect.
Changes in patent laws or patent jurisprudence could diminish the value of patents in general thereby impairing our
ability to protect our products.
Changes in patent law across jurisdictions, or changes in any relevant government’s enforcement procedure may weaken
our ability to obtain new patents or to enforce rights in our owned and licensed patents. For example, the U.S. Supreme
Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in
certain circumstances or weakening the rights of patent owners in certain situations. Relatedly, the U.S. Congress is
considering multiple draft bills that, if passed, may have a significant impact on U.S. patent laws. Any such changes by
22 | ||
the U.S. Congress or U.S. courts and the relevant law-making bodies in other countries may materially affect our patents
or patent applications and we cannot predict the effects of future changes in patent law.
We may be unable to protect the confidentiality of our trade secrets and their disclosure to competitors, harming our
market position.
In addition to patent protection, we rely on trade secret protection to preserve the value of our proprietary information
supporting our business model. We take balanced measures to preserve the commercial value of our trade secrets and
prevent their misappropriation. However,despite these measures, which include segregation of key files, requiring our
licensors, collaborators, suppliers, consultants and advisors to execute confidentiality agreements, we cannot fully
protect against willful or inadvertent unauthorized disclosure of our trade secrets. Trade secret enforcement proceedings
can be unpredictable and vary across geographies and we may not be able to secure adequate legal or equitable remedies
to prevent lost value in our misappropriated trade secrets. Any misappropriation and use, whether willful or inadvertent,
could result in lost value to the company and enable our competitors to duplicate or build upon our technology.
Risk Factors Related to argenx’s Organization and Operations
Our future growth and ability to compete depends on maintaining our culture, retaining our key personnel and
recruiting additional qualified personnel.
We believe that our corporate culture has been, and will continue to be a key contributor to our success. However, as we
implement more complex organizational structures, and increase our headcount to support the growth in our business,
our ability to foster our key values - innovation, co-creation, empowerment, excellence and humility that we believe are
important to support our growth - may be impacted. We may find it increasingly difficult to maintain the beneficial
aspects of our corporate culture, which could similarly negatively impact our ability to attract, retain and motivate
qualified employees and our future success.
As a global organization in a highly competitive and specialized industry, our success also depends upon the continued
contributions of our key management, scientific, medical and technical personnel, many of whom have been
instrumental for us and have substantial experience with our product and related technologies. These key management
individuals include the members of the Board of Directors and Senior Management Team. Difficulties in recruiting or
the loss of key managers, scientific, medical or technical personnel could delay our research and development activities.
In addition, it may be difficult to attract and retain highly qualified management, scientific and medical personnel,
particularly if we expand into fields that will require additional skills. In addition, future leadership transitions and
management changes may cause uncertainty in, or a disruption to, our business, and may increase the likelihood of
senior management or other employee turnover. We are currently undergoing a leadership transition, as in early January
2026, we announced that Karen Massey, our current COO, will transition to the role of CEO and Executive Director and
Tim Van Hauwermeiren, our current CEO, will transition to the role of Non-Executive Director and Chairperson of the
Board of Directors. Both transitions are subject to shareholder approval at the 2026 General Meeting. Any failure to
ensure an effective transition or any future management changes could adversely affect our business, and we cannot
predict the likelihood, timing or effect of future transitions among our executive leadership.
As a Dutch company listed on Euronext Brussels and Nasdaq, our remuneration practices and policies may be limited by
local governance rules or shareholder guidance for EU companies. Such limitations may make it more difficult to
successfully compete for key talent in a number of markets with differing remuneration practices and policies compared
to our competitors. For example, the Dutch Corporate Governance Code 2025 (DCGC) places certain limitations on the
ability to grant equity incentives to Non-Executive Directors, while Belgian law requires Non-Executive Directors to
receive part of their remuneration in the forms of shares, but not stock options. The DCGC also places limitations on
amount of severance payment permitted in the event of dismissal.
Many other biotechnology and pharmaceutical companies and academic institutions that we compete against for
qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry
than we do. Additionally, inflationary pressures and a tight labor market for skilled workers may increase compensation
expectations, requiring us to raise operating costs in order to attract and retain employees. Therefore, we might not be
able to attract or retain these key persons or other employees on conditions that are economically acceptable.
Global geo- and socio-political threats and macro-economic uncertainty and other unforeseen political crises could
materially and adversely affect our business and financial performance.
Many geo- and socio-political threats and macro-economic uncertainties are outside of our control and could adversely
affect consumer confidence and disposable income levels, increase difficulty in forecasting our financial results and have
other impacts on our business and financial performance. Such geo- and socio-political threats could also result in
23 | ||
volatility in stock markets in general, causing our stock to have extreme price and volume fluctuations unrelated to our
business and financial performance.
Such geo- and socio-political threats and uncertainties include:
•general economic and market conditions, including government shutdowns, including the U.S. government shutdown,
instability resulting from inflationary pressures, and increasing interest rates;
•geopolitical events, including natural disasters, public health emergencies, acts of war, and terrorism;
•economic and financial sanctions, trade embargoes, import and export regulations, tariffs, customs, and inbound and
outbound investment restrictions;
•restrictions, changes in trade agreements, trade barriers or other restrictions on foreign trade, and changes in trade
regulations and restrictions, including between the U.S. and other countries;
•global or regional economic conditions that impact companies and customers with which we do business;
•political or social unrest, economic instability, repression, or human rights issues;
•disruptions in supply chains;
•risks related to other government regulation or required compliance with local laws;
•consumer and commercial credit availability, unemployment, and consumer debt levels; and
•local licensing and reporting obligations.
Due to our international operations and the fact that we run clinical trials across multiple jurisdictions, geopolitical
conflicts and related sanctions may, in certain circumstances, impact our ability to conduct or complete clinical trials in
the affected regions. For example, General License 6D issued by the U.S. Department of the Treasury’s Office of
Foreign Assets Control currently authorizes certain clinical trial and medical research activities that would otherwise be
restricted by U.S. sanctions targeting Russia, the scope, availability, or duration of such authorizations may change.
We also perform development activities in a number of countries exposed to geopolitical risk and if conflicts in those
countries were to escalate further and impact neighboring countries, it could impact our development activities in those
countries.
Changes in U.S.-Mainland China relations, including tariffs, export controls, economic and financial sanctions, and other
regulations may adversely impact our collaboration with Zai Lab in Mainland China, Hong Kong, Taiwan and Macau
(together, Greater China). The U.S. government has taken steps and continues to take steps with regard to U.S.-Mainland
China relations that will impact companies with connections to the U.S. or Mainland China, including by imposing
tariffs affecting certain products manufactured in Mainland China, imposing economic and financial sanctions on certain
individuals and entities in the Mainland China, and issuing statements indicating enhanced review of companies with
significant Mainland China-based operations. The U.S. government has also passed laws, including the BIOSECURE
Act, which was signed into law on December 18, 2025, that could limit or restrict our ability to purchase products or
services from, or otherwise collaborate with, certain Chinese biotechnology companies without losing our ability to
contract with or receive funding from the U.S. government. Such restrictions could have an adverse impact on our
operations.
Several countries are considering or have implemented tariffs, trade barriers or restrictions, as well as other measures
impacting cross-border commerce, which could negatively affect our business, financial conditions and results of
operations, including by disrupting our research and development activities, affecting our suppliers and negatively
impacting our supply chain, impacting our ability to sell our products outside of the United States and negatively
impacting our revenues from product sales or our cost of goods sold. The U.S. federal government has implemented
tariffs on certain foreign goods and may implement additional or revised tariffs in the future. Such actions could give rise
to retaliatory tariffs imposed by foreign governments and an escalation of trade measures by the U.S. and impacted
countries. Developments with regard to the timing and manner in which tariffs will be implemented; the amount, scope,
and nature of tariffs; the countries subject to new or additional tariffs imposed by the U.S.; tariffs imposed by other
countries on goods imported from the U.S.; and other wide-ranging retaliatory measures are rapidly evolving and may
change unexpectedly at any time. For example, the U.S. President has repeatedly announced plans to impose 100%
tariffs on imported branded or patented pharmaceuticals, unless the importing company is building U.S. manufacturing
capacity. It is not yet clear whether these tariffs would apply to the importation of active pharmaceutical ingredients and
24 | ||
possibly bulk drug products that are intended for use in clinical trials and not for commercial sale, which could increase
the costs of materials for our clinical trials. Any direct tariffs, if imposed on pharmaceutical products, may result in
increased costs for raw materials and contract manufacturing services, reduced ability to source critical CMOs, and a
delay in our development timelines. Although on February 20, 2026, the U.S. Supreme Court struck down certain tariffs
imposed by the Trump Administration pursuant to the International Emergency Economic Powers Act, the Trump
Administration responded by announcing new tariffs pursuant to another statute. Other countries may, in turn, retaliate
with new tariffs against US exports. These events increase the uncertainty and the risks we face resulting from tariffs
described above.
Any new legislation, executive orders, tariffs, export controls, economic and financial sanctions, trade embargoes and/or
other regulations that may be implemented, any unfavorable government policies on international trade, including tariffs
and export controls, the renegotiation of existing trade agreements, any increased scrutiny on companies with significant
Mainland China-based operations, and any retaliatory actions taken by the U.S., EU, Chinese or other governments due
to trade tensions could have an adverse effect on our business, including the development and commercialization of
products containing argenx-licensed material. Further, general political uncertainty may have an adverse impact on our
business, financial condition and results of operations.
We face risks related to natural disasters and public health issues, that could negatively affect our business and
financial condition.
Our business could be adversely impacted by the effects of catastrophic global events including natural disasters such as
earthquakes, fires, hurricanes, tornados, floods or significant power outages and public health crises.
For example, the manufacturing of all of our products and product candidates requires using cells which are stored in a
cell bank. We have one master cell bank for each product manufactured in accordance with cGMPs. However, it is
possible that we could lose multiple cell banks and have our manufacturing significantly impacted by the need to replace
these cell banks, which could materially adversely affect our business, prospects, financial condition and results of
operations. Public health issues could also negatively affect our business and financial condition. We operate and
conduct our clinical trials globally. We cannot presently predict the scope and severity of any potential future business
shutdowns or disruptions as a result of public health issues. If we or any of the third parties with whom we engage,
including the suppliers, contract manufacturers, clinical trial sites, regulators and other third parties, were to experience
shutdowns, quarantines, or other business disruptions due to natural disasters or global public health issues, it may
impair our or our third-party partners’ ability to initiate clinical trials and recruit and retain patients, particularly if
quarantine or travel restrictions impede healthcare provider or patient movement, impact the usability of the data due to
treatment interruptions and require protocol amendments. In addition, regulatory authorities may restrict their operations
or be delayed in their operations during a pandemic, the outbreak of new variants or other public health issues, including
further to travel restrictions which could adversely affect our ability to obtain regulatory approval for and to
commercialize our products and product candidates and have a material adverse effect on our business and financial
results.
We are exposed globally to unanticipated changes in tax laws and regulations, adjustments to our tax provisions,
exposure to additional tax liabilities, or adjustments of our tax assets.
As a company active in research and development, we have benefited from certain research and development tax
incentives including tax credits and a payroll withholding tax exemption. We also expect to benefit from the Belgian
innovation income deduction.
The determination of our provision for income taxes and other tax liabilities requires judgment, including the adoption of
certain accounting policies and our determination of whether our deferred tax assets are, and will remain, fully available
in future periods. We cannot guarantee that our interpretation of applicable tax laws (including with respect to our
eligibility for, or our calculation of, tax incentives such as the Belgian R&D tax credit, the Belgian payroll withholding
tax exemption for R&D personnel, the Belgian innovation income deduction and similar tax incentives in other
jurisdictions in which we have material operations or sales), our transfer pricing policies or our organizational and
operational structure will not be questioned by the relevant tax authorities, or that the relevant tax laws and regulations,
or the interpretation thereof, including through tax rulings, will not be subject to change. Our effective tax rates could be
adversely affected, now or in the future, by changes in tax laws, treaties and regulations or the interpretation thereof by
the relevant tax authorities in countries where we have material operations. A successful challenge to tax positions in
Belgium or other country where we have material operations may lead to adjustments in the amounts recorded in our
financial statements and could have a significant impact on our effective tax rate and on our deferred tax assets. An
increase of the effective tax rates could have an adverse effect on our business, financial position, results of operations
and cash flows.
In case of a change of control, we could be exposed to the risk of losing any unused tax credit and innovation income
deduction. Furthermore, if any legislator decides to eliminate, or change the conditions for claiming such tax incentives,
25 | ||
or reduce the scope or the rate of such incentives, any of which it could decide to do at any time, our results of operations
could be adversely affected including through the de-recognition of deferred tax assets.
We may encounter difficulties efficiently managing our growth and our increasing development, regulatory, and sales
and marketing capabilities, which could disrupt our operations.
We have grown, and expect to continue to grow globally, significantly in the number of employees and scope of
operations over recent years, particularly in the areas of drug research, drug development, regulatory affairs, and sales
and marketing. To manage our anticipated future growth and support our expanding global footprint, we must continue
to enhance our managerial, operational and financial systems, expand our facilities and recruit and train additional
qualified personnel and build the internal infrastructure necessary. Any inability to manage growth effectively could
delay the execution of our strategic objectives or disrupt our operations, which in turn could materially harm our
business and prospects.
In particular, our planned international expansion subjects us to a number of risks, including risks following complexities
in monitoring and coordinating research and development, marketing, supply chain and other operations in a large
number of jurisdictions, risks related to laws, regulations and policies, including those implemented following changes in
political leadership and trade, risks related to varying standards and practices in the legal, regulatory and business
cultures in which we operate, risks related to capital and exchange controls, cross-border taxes and tariffs, cross-border
data transfer restrictions, and complex sanctions regimes in various countries such as the U.S., the EU and other
jurisdictions, violations of which could lead to fines or other penalties, risks related to geopolitical and local political
instability and uncertain business environments and risks related to complexities associated with managing local
personnel and preventing misconduct by local third-party partners.
The application of laws and regulations impacting global business operations is often unclear and may at times conflict.
Compliance with these laws and regulations may involve significant costs or require changes in our business practices
that result in reduced revenue and profitability. Non-compliance could also result in fines, damages, criminal sanctions,
prohibited business conduct, and damage to our reputation.
Risk Factors Related to the ADSs
Holders of our ADSs have fewer rights than our ordinary shareholders.
Except as described in this Annual Report or any deposit agreements, holders of ADSs are not treated as our
shareholders unless they withdraw the ordinary shares underlying their ADSs in accordance with the deposit agreement
and applicable laws and regulations. The depositary, or its nominee, is the holder of the ordinary shares underlying the
ADSs. ADSs are transferable on the books of the depositary. The depositary may refuse to deliver, transfer or register
transfers of ADSs. Temporary delays in the cancellation of ADSs and withdrawal of the underlying ordinary shares may
arise. In addition, ADS holders may not be able to cancel their ADSs and withdraw the underlying ordinary shares when
they owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply
with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited
securities.
Holders of ADSs may vote them in person or by proxy in accordance with applicable laws and regulations and our
articles of association (Articles of Association). We cannot guarantee that holders of ADSs will receive the voting
materials in time to ensure that they can instruct the depositary to vote the ordinary shares underlying their ADSs.
Holders of our ADSs may not be able to exercise their right to give voting instructions or to vote in person or by proxy
and they may not have any recourse against the depositary or us if their ordinary shares are not voted as they have
requested or if their shares cannot be voted.
The price of our ADSs may be volatile and may fluctuate due to factors beyond our control. An active public trading
market may not be sustained.
The stock markets in general, and biopharmaceutical companies in particular, have experienced extreme price and
volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
The trading price of our ADSs depends on a number of factors, including those described elsewhere in this “Risk
Factors” section, many of which are beyond our control and may not be related to our operating performance, which may
limit or prevent investors from readily selling their ADSs or ordinary shares and may otherwise negatively affect the
liquidity of our ADSs and ordinary shares. We provide guidance regarding our cash and expenses, which are inherently
uncertain. Any guidance that we provide may not always be accurate or may vary. If we fail to meet our guidance, or if
we have to revise such guidance, the price of our ADSs or ordinary shares could decline. Sales of a substantial number
of ADSs or our ordinary shares in the public market, or the perception that these sales might occur, could depress the
26 | ||
market price of ADSs or our ordinary shares and could impair the market price of our securities or our ability to raise
capital through the sale of additional equity securities.
In addition, an active public trading market for our ADSs may not be sustained. Further, fluctuations in exchange rates
may also impact the price of our ADSs and ordinary shares which may result in heavy trading by investors seeking to
exploit such differences, or impact the proceeds holders receive.
If securities or industry analysts cease coverage of us, or publish inaccurate or unfavorable research about our
business, the price of our ADSs or ordinary shares and our trading volume could decline.
The trading market for the ADSs and ordinary shares depends in part on the research and reports that securities or
industry analysts publish about us or our business. We do not have control over these analysts. If no or too few securities
or industry analysts cover us, the trading price of our ADSs and ordinary shares would likely be negatively affected. If
one or more of the analysts who cover us downgrade our ADSs or ordinary shares or publish inaccurate or unfavorable
research about our business, the price of our ADSs or ordinary shares would likely decline.
If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our
ability to comply with applicable regulations could be impaired, and the trading price of our ADSs may be negatively
impacted.
We are required to comply with various corporate governance and financial requirements under the Sarbanes-Oxley Act
of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing rules of the Nasdaq Global
Market (the Nasdaq Listing Rules) and requirements, and other applicable securities rules and regulations. We are
required to furnish a report by management on, among other things, the effectiveness of our internal control over
financial reporting and an attestation report on internal control over financial reporting issued by our independent
registered public accounting firm. Undetected material weaknesses in our internal controls could lead to financial
statement restatements and require us to incur the expense of remediation. Moreover, any failure to maintain internal
control over financial reporting or any material weaknesses or significant deficiency thereover, could result in a loss of
investors’ in the accuracy, completeness and reliability of our financial statements, subject us to sanctions or
investigations, or negatively impact the trading price of our ADSs or ordinary shares.
Risk Factors Related to being a Foreign Private Issuer or a Dutch Company
The risks in this subsection that relate to our status as a foreign private issuer will change if we lose our status as a
foreign private issuer under U.S. law.
We are a Dutch European public company with limited liability. The rights of our shareholders may be different from
the rights of shareholders in companies governed by the laws of U.S. jurisdictions.
We are a Dutch European public company with limited liability (Societas Europeae). The rights of shareholders and the
responsibilities of members of our Board of Directors may be different from the rights and obligations of shareholders in
companies governed by the laws of U.S. jurisdictions.
As a result of these differences between Dutch corporate law and our Articles of Association, on the one hand, and the
U.S. federal and state laws, on the other hand, in certain instances, our shareholders and holders of our ADSs could
receive less protection than they would as shareholders or ADS holders of a listed U.S. company.
For example, provisions of our Articles of Association may make it more difficult for a third party to acquire control of
us or effect a change in our Board of Directors. We have adopted several provisions that may have the effect of making a
takeover of our Company more difficult or less attractive. These provisions could discourage potential takeover attempts
that other shareholders may consider to be in their best interest and could adversely affect the market price of our
securities.
Holders of our ordinary shares outside the Netherlands, and holders of ADSs may not be able to exercise pre-emptive
rights or preferential subscription rights, respectively.
In the event of an increase in our share capital, holders of our ordinary shares are generally entitled under Dutch law to
full pre-emptive rights, unless these rights are excluded either by a resolution of the shareholders at a General Meeting,
or by a resolution of the Board of Directors (if the Board of Directors has been designated by the shareholders at a
General Meeting for this purpose).
However, making pre-emptive rights available to holders of ordinary shares or ADSs representing ordinary shares also
requires compliance with applicable securities laws in the jurisdictions where holders of those securities are located,
27 | ||
which we may be unable or unwilling to do. In particular, holders of ordinary shares or ADSs located in the U.S. would
not be able to participate in a pre-emptive rights offering unless we registered the securities to which the rights relate
under the U.S. Securities Act of 1933, as amended (Securities Act) or an exemption from the registration requirements.
In addition, ADS holders would not be able to participate in a pre-emptive rights offering unless we made arrangements
with the depositary to extend that offering to holders of ADSs, which we are not required to do.
Claims of U.S. civil liabilities may not be enforceable against us or the members of our Senior Management Team
and our Board of Directors.
A significant amount of our assets are located outside the U.S. The majority of the members of our Senior Management
Team and our directors are not U.S. residents and we do not have significant assets in the U.S. As a result, it may not be
possible, or more difficult, for investors to enforce against them or us in U.S. courts, including judgments predicated
upon the civil liability provisions of the U.S. federal securities laws. There are no treaties between the U.S. with either
the Netherlands or Belgium providing for the reciprocal recognition and enforcement of judgments, other than arbitration
awards, in civil and commercial matters. Consequently, a final judgment for payment given by a court in the U.S. based
on civil liability, whether or not predicated solely upon U.S. securities laws, would not automatically be recognized or
enforceable in the Netherlands or in Belgium unless the underlying claim was re-litigated before a Dutch or Belgian
court of competent jurisdiction. This will depend on the applicable Dutch or Belgian national rules. In addition, there is
doubt as to whether a Dutch or Belgian court would impose civil liability on us or the members of our management or of
our Board of Directors in an original action predicated solely upon the U.S. federal securities laws brought in a court of
competent jurisdiction against us, our management or directors.
As a foreign private issuer, we are exempt from various rules and regulations that a U.S. domestic public company
would be required to follow, including those requirements under U.S. securities laws and Nasdaq listing standards.
As a “foreign private issuer” defined in the SEC’s rules and regulations, we are not subject to all of the disclosure and
corporate governance requirements applicable to companies organized within the United States. For example, we are
exempt from certain provisions of the U.S. Securities Exchange Act of 1934, as amended (Exchange Act), that are
applicable to U.S. domestic public companies. In addition, our executive officers, directors and principal shareholders
are exempt from the short-swing profit and recovery provisions contained in Section 16(b) of the Exchange Act. We are
subject to Dutch laws and regulations with regard to such matters. While we furnish quarterly unaudited financial
information to the SEC on Form 6-K, the information we furnish to the SEC is less extensive and less timely compared
to that required to be filed with the SEC by U.S. domestic issuers.
As a foreign private issuer listed on Nasdaq, we are subject to corporate governance listing standards. However, we are
permitted to rely on home country governance requirements and certain exemptions thereunder. Certain of our corporate
governance practices may differ significantly from the Nasdaq corporate governance listing standards. These practices
may afford less protection to shareholders than they would enjoy if we complied fully with corporate governance listing
standards.
As a Dutch public company with limited liability, we are not obligated to, and do not comply with, all the best practice
provisions of the DCGC, which may affect shareholders’ rights. We are required to disclose in our annual report, filed in
the Netherlands, whether we comply with the provisions of the DCGC. If we do not comply with the provisions of the
DCGC, we must list the reasons for any deviation from the DCGC in our annual report filed in the Netherlands.
We may lose our foreign private issuer status which would then require us to comply with the Exchange Act’s
domestic reporting regime and cause us to incur significant legal, accounting and other expenses.
In order to maintain our current status as a foreign private issuer, either (a) a majority of our ordinary shares must be
either directly or indirectly owned of record by non-residents of the U.S. or (b) none of the following conditions may be
true: (i) a majority of our executive officers or directors are U.S. citizens or residents, (ii) more than 50% of our assets
are located in the U.S. and (iii) our business is administered principally in the U.S. As of February 19, 2025, we believe
at least 50% of our outstanding ordinary shares were held by U.S. residents (assuming that all our ordinary shares
represented by ADSs were held by residents of the U.S.).
In June 2025, the SEC issued a concept release soliciting public comment on potential changes to the definition of a
foreign private issuer. This release is the first review of the foreign private issuer framework since 2008, and the SEC is
considering revisions that could significantly impact which foreign companies qualify for the more accommodative U.S.
reporting, corporate governance requirements afforded to foreign private issuers, as well as the lack of Section 16(b)
liability for certain FPI officers, directors and shareholders. The SEC may revise the requirements to qualify as a foreign
private issuer in a way that changes our status as a foreign private issuer and results in us qualifying as a U.S. domestic
issuer. This could cause us to have to comply with regulations applicable to U.S. domestic issuers in a very compressed
timeframe. The regulatory and compliance costs to us as a U.S. domestic issuer may be significantly higher than those
28 | ||
we incur as a foreign private issuer. We also expect that if we were required to comply with the rules and regulations
applicable to U.S. domestic issuers, it would make it more difficult and expensive for us to obtain director and officer
liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain
coverage. These rules and regulations could also make it more difficult for us to attract and retain qualified members of
our Board of Directors.
If we were to be classified as a passive foreign investment company for U.S. federal income tax purposes, this could
result in adverse U.S. tax consequences to certain U.S. holders.
If the Company is classified as a passive foreign investment company (PFIC) for any taxable year, U.S. investors may be
subject to adverse U.S. federal income tax consequences described below under “Item 10.E Taxation — Certain Material
U.S. Federal Income Tax Considerations for U.S. Holders” The Company will be classified as a PFIC for U.S. federal
income tax purposes for any taxable year in which, taking into account a pro rata portion of the income and assets of
25% or more owned subsidiaries, either (i) at least 75% of its gross income consists of “passive income” or (ii) at least
50% of the average quarterly value of its assets is attributable to assets that produce, or are held for the production of,
passive income.
Based on our historic and anticipated operations, the composition of our income and the projected composition and
estimated fair market values of our assets, we do not believe that we were a PFIC for our most recent taxable year and do
not expect to be classified as a PFIC for the current taxable year or for the foreseeable future. However, our status as a
PFIC is a factual determination made on an annual basis, and we cannot provide any assurances regarding our PFIC
status for the current or future taxable years.
ITEM 4.INFORMATION ON THE COMPANY
A.HISTORY AND DEVELOPMENT OF THE COMPANY
Our legal and commercial name is argenx SE. We were incorporated under the laws of the Netherlands on April 25,
2008, as a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid). From
incorporation until August 28, 2009, our research and development activities were initially performed in the Netherlands,
then Belgium, by argenx N.V. and its legal predecessors. Since August 28, 2009, all our research and development
activities have been performed by our wholly-owned subsidiary, argenx BV, under a license provided by argenx N.V.
Throughout this time, argenx BV assigned all resulting intellectual property to argenx N.V. On May 28, 2014, we
converted to a Dutch public company with limited liability (naamloze vennootschap). On April 26, 2017, we converted
to a Dutch European public company with limited liability (Societas Europaea or SE). On May 5, 2017, we transferred
the legal ownership of all intellectual property rights of argenx SE to argenx BV, effective retroactively as of January 1,
2017. As a result, since January 1, 2017, (i) argenx BV holds all legal and economic ownership of our intellectual
property rights, and (ii) the research and development agreement between argenx SE and argenx BV has been
terminated.
Our official seat is in Amsterdam, the Netherlands, and our registered office is at Laarderhoogtweg 25,
1101 EB Amsterdam, the Netherlands. We are registered with the trade register of the Dutch Chamber of Commerce
under number 24435214. Our European legal entity identifier number (LEI) is 7245009C5FZE6G9ODQ71. Our
telephone number is +31 (0) 10 70 38 441. Our website address is www.argenx.com. This website is not incorporated by
reference in this Annual Report. The SEC maintains an Internet site that contains reports, proxy and information
statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov. The registered
agent for service of process in the U.S. is CT Corporation System, with an address at 111 8th Avenue, New York, NY
10011.
For information on our capital expenditure for the years ended December 31, 2025, 2024 and 2023, please see
“Note 4 — Property, Plant and Equipment” and “Note 5 — Intangible Assets” in our consolidated financial statements
which are included at the end of this Annual Report on Form 20-F for the period ended December 31, 2025. We
anticipate our capital expenditure in 2026 to be financed from the cash flows from operating activities and cash reserves.
For more information on our capital expenditures and requirements, see “Item 5.B. — Liquidity and Capital Resources —
Cash Flows — Operating and Capital Expenditure Requirements” in our Annual Report for the period ended
December 31, 2025.
No takeover bid has been instigated by third parties in respect of our equity during the current or previous fiscal years.
29
B.BUSINESS OVERVIEW
Our legal and commercial name is argenx SE. We were incorporated under the laws of the Netherlands on April 25,
2008, as a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid). From
incorporation until August 28, 2009, our research and development activities were initially performed in the Netherlands,
then Belgium, by argenx N.V. and its legal predecessors. Since August 28, 2009, all our research and development
activities have been performed by our wholly-owned subsidiary, argenx BV, under a license provided by argenx N.V.
Throughout this time, argenx BV assigned all resulting intellectual property to argenx N.V. On May 28, 2014, we
converted to a Dutch public company with limited liability (naamloze vennootschap). On April 26, 2017, we converted
to a Dutch European public company with limited liability (Societas Europaea or SE). On May 5, 2017, we transferred
the legal ownership of all intellectual property rights of argenx SE to argenx BV, effective retroactively as of January 1,
2017. As a result, since January 1, 2017, (i) argenx BV holds all legal and economic ownership of our intellectual
property rights, and (ii) the research and development agreement between argenx SE and argenx BV has been
terminated.
For additional information regarding our Company’s principal markets and revenue breakdown, see “Item 5.A. —
Operating Results” in our Annual Report for the period ended December 31, 2025.
2025 In Brief
Operational Highlights
2025 was a year of strong execution as we advanced our long‑term commitment to patients under Vision 2030: aiming to
treat 50,000 patients globally, secure 10 labeled indications across all approved medicines, and advance five pipeline
candidates into Phase 3 development by 2030. We made significant progress executing against this goal throughout the
year, by expanding our global reach with VYVGART in two blockbuster indications, advancing 10 ongoing
registrational clinical trials, and completed our goal to bring forward four Phase 1 molecules by the end of the decade.
Throughout 2025, VYVGART continued to deliver meaningful impact for patients globally, reaching more than 19,000
patients across three indications (gMG, CIDP, and ITP) and three product presentations. We successfully launched our
PFS, which expanded access to new patient segments and enabled more convenient treatment options. In gMG, we
strengthened our position as the #1 prescribed and fastest‑growing biologic, supported by increasingly earlier use in the
treatment paradigm and continued expansion into broader patient populations. Positive topline data from the
Seronegative gMG clinical trial strengthened our ambition to be the treatment of choice and to pursue the broadest MG
label to date. In CIDP, real‑world outcomes continued to validate the ADHERE results, with physicians reporting
sustained functional improvement and patients experiencing greater independence and quality of life. This strong
commercial execution resulted in a milestone for the Company, with VYVGART surpassing $1 billion in product net
sales in a single quarter for the first time in the third quarter of 2025.
Across the pipeline, we made meaningful progress on a broad set of programs. We advanced efgartigimod through
additional Phase 3 clinical trials that are expected to read out in 2026: Myositis and ITP, each supported by compelling
biology and robust clinical or proof‑of‑concept data. Together, we believe these programs strengthen efgartigimod’s
position as a foundational FcRn‑based therapy with potential across multiple high‑need autoimmune diseases.
Our second asset, empasiprubart, advanced notably with three Phase 3 clinical trials underway in MMN and CIDP. As a
first‑in‑class antibody targeting complement C2, we further expanded our understanding of C2 biology and its potential
to set a new bar for treatment outcomes in immune‑mediated neuromuscular diseases. Momentum also continued with
adimanebart (ARGX‑119), which entered Phase 3 development in CMS and progressed in a proof-of-concept clinical
trial in spinal muscular atrophy (SMA). Across our early‑stage portfolio, we advanced key next‑generation programs,
which include ARGX-213 and ARGX-124. We have a highly productive IIP, our engine for sourcing novel biology and
accelerating differentiated medicines, with over 25 active programs. Together, these achievements and the progress
across our pipeline position us well for the year ahead as we prepare for multiple registrational readouts and continued
expansion of our global patient impact.
Corporate Achievements
•Subject to shareholder approval, Karen Massey, current COO, will transition to CEO and Executive Director and Tim
Van Hauwermeiren, current CEO, will transition to Non-Executive Chairperson of the Board of Directors.
•In 2025, Sandrine Piret-Gérard was appointed Chief Commercialization Officer. Sandrine joins from Gilead, where
she lead the U.S. commercial organization.
30 | ||
•Anthony Rosenberg, who has served as a non-executive director since April 2017, was reappointed as a non-
executive director and vice-chairperson of the Board of Directors for a term of 2 years.
•Expansion to 1,863 full-time employees (as of December 31, 2025) to support further growth of our business,
including fully staffed commercial teams in the U.S., Europe, Japan and Canada.
2025 Financial Highlights
•Product net sales of $4.2 billion
•Research & development of $1.4 billion
•Financial Strength to Invest in Sustainable innovation.
2026 Outlook
2026 marks a defining year on the path to Vision 2030 with three strategic priorities:
•Impact more patients globally with VYVGART, driving broader adoption across current patient populations and
unlocking new opportunities with potential label expansions
•Shape the long-term future of FcRn medicines, advancing future FcRn molecules, innovative delivery modalities and
combination approaches designed to transform patient outcomes
•Deliver next wave of immunology innovation, accelerating empasiprubart and diversified pipeline of first-in-class
molecules to drive sustainable value creation
31 | ||
The table above is subject to risks and uncertainties that may materially impact the achievement of our 2026 outlook. For
more information, please refer to “Item 3.D. — Risk Factors” of this Annual Report for a discussion of such risks and
uncertainties.
Our Medicines
VYVGART and VYVGART HYTRULO is a first-and-only immunoglobulin G (IgG) Fc-antibody fragment that targets
the FcRn. It is approved for the treatment in three indications, including gMG and CIDP globally and ITP in Japan (as
VYVDURA).
Our Pipeline
•efgartigimod is an IgG1 antibody Fc fragment that has been engineered for increased affinity to FcRn compared to
endogenous IgG. Efgartigimod selectively reduces IgG by blocking FcRn-mediated IgG recycling without impacting
antibody production or affecting other parts of the immune system. It is approved in three indications, including
gMG, CIDP and ITP, and is being evaluated in more than ten additional serious autoimmune indications.
•empasiprubart (C2 inhibitor) is a novel complement inhibitor targeting C2, blocking the function of both the classical
and lectin pathways while leaving the alternative pathway intact. We believe empasiprubart has the potential to be a
pipeline-in-a-product candidate and is being evaluated in two indications currently in Phase 3 clinical trials.
•adimanebart (MusK agonist): adimanebart is an agonist SIMPLE ANTIBODY™ to the MuSK receptor with potential
in multiple neuromuscular indications. It is currently in clinical trials for CMS (Phase 3 clinical trial) and SMA
(Phase 2).
•Earlier Stage Programs:
◦Two future FcRn molecules are progressing: ARGX-213, an FcRn-targeted antibody engineered for half-life
extension and sustained IgG reduction, and ARGX-124, a first-in-class FcRn pipeline candidate.
◦ARGX-109 (targeting IL-6) and ARGX-121 (a first-in-class molecule targeting immunoglobulin A (IgA)) are also
progressing.
◦Entered into a research collaboration with Tensegrity Pharma, including an option for future acquisition, to
advance Tensegrity’s lead program TSP-101 in autoimmune disease and other indications.
◦Three new molecules expected to enter Phase 1 clinical trials in 2026, including ARGX-118, a first-in-class
molecule targeting Galectin-10, ARGX-125, a first-in-class bispecific antibody, and TSP-101, targeting Fn14.
•In addition to our wholly-owned pipeline, we have candidates that emerged from our IIP that we out-licensed to a
partner for further development and for which we have milestone, royalty or profit-share agreements. These
candidates include, amongst others: cusatuzumab (anti-CD70 antibody – OncoVerity), ARGX-112 (LP-0145 – anti-
IL-22R antibody – LEO Pharma), ARGX-114 (AGMB-101 – agonistic anti-MET antibody – Agomab) and
ARGX-115 (ABBV-151 – anti-GARP antibody – AbbVie).
Immunology Innovation Program (IIP)
Our IIP is the engine behind our robust and expansive pipeline. By fostering deep, ongoing collaboration between
leading academic researchers and our in-house antibody engineers, we aim to translate breakthrough science into first-in-
class therapies across multiple indications. This co-creation model has enabled every candidate in our wholly owned and
partnered pipelines to emerge from IIP collaborations, underscoring our ability to identify and advance novel targets with
speed and precision.
Our approach is designed for scale and sustainability: we run parallel development programs, optimize trial design for
efficiency, and maintain a relentless focus on unmet patient needs. This strategy has delivered measurable results –
accelerating our path to profitability, driving strong commercial growth, and positioning argenx as a leader in
immunology innovation. By integrating the aspirations of patients and the insights of healthcare professionals into every
stage of discovery and development, we are not only building a differentiated pipeline but also setting new standards for
impact and value creation in the sector.We bring to the collaboration our unique suite of antibody discovery and
antibody engineering technologies and experience in clinical development to complement our partners’ expertise in
disease and target biology. Our suite of technologies includes amongst others our SIMPLE ANTIBODY™ platform
technology and NHANCE™, ABDEG™, POTELLIGENT®, and DHS mutations that focus on engineering the Fc region
of antibodies in order to augment their intrinsic therapeutic properties.
32
Our Suite of Technologies
•SIMPLE ANTIBODY™ platform technology: Our proprietary SIMPLE ANTIBODY™ platform technology, based
on the powerful llama immune system, allows us to exploit novel and complex disease biology targets. The platform
sources antibody variable regions (V-regions) from the immune system of outbred llamas, each of which has a
different genetic background. The llama produces highly diverse panels of antibodies with a high human homology,
or similarity, in their V-regions when immunized with targets of human disease. Our SIMPLE ANTIBODY™
platform technology allows us to access and explore a broad target universe while potentially minimizing the long
timelines associated with generating antibody candidates using traditional methods.
•NHANCE™, ABDEG™, POTELLIGENT®, and DHS mutations focus on engineering the Fc region of antibodies in
order to augment their intrinsic therapeutic properties. In addition, we obtained a non-exclusive research license and
option from Chugai Pharmaceutical Co., Ltd. for the SMART-Ig® (“Recycling Antibody” and part of “Sweeping
Antibody”) and ACT-Ig® (Antibody half-life extending) technologies. These technologies are designed to enable us to
expand the therapeutic index of our product candidates, which is the ratio between toxic and therapeutic dose, by
potentially modifying their half-life, tissue penetration, rate of disease target clearance and potency.
Our Products and Product Candidates
The following table summarizes key information on our portfolio of lead products and product candidates as of the date
of this Annual Report.
Program | Indication | Preclinical | Phase 1 | Proof of Concept | Registrational | Commercial | ||||||
VYVGART | gMG | |||||||||||
ITP (Japan) | ||||||||||||
VYVGART HYTRULO | gMG | |||||||||||
CIDP | ||||||||||||
efgartigimod | Seronegative gMG | |||||||||||
Ocular MG | ||||||||||||
Primary ITP | ||||||||||||
Graves’ Disease | ||||||||||||
Myositis | ||||||||||||
SjD | ||||||||||||
Systemic Sclerosis | ||||||||||||
AMR | ||||||||||||
empasiprubart | MMN | |||||||||||
DGF | ||||||||||||
CIDP | ||||||||||||
adimanebart | CMS | |||||||||||
SMA | ||||||||||||
ARGX-213 | Undisclosed | |||||||||||
ARGX-121 | IgA Nephropathy | |||||||||||
ARGX-124 | Undisclosed | |||||||||||
ARGX-109 | Undisclosed | |||||||||||
TSP-101 | Undisclosed | |||||||||||
ARGX-118 | Undisclosed | |||||||||||
ARGX-125 | Undisclosed |
NEUROLOGY | NEPHROLOGY AND HEMATOLOGY | ENDOCRINOLOGY | RHEUMATOLOGY | UNDISCLOSED |
33
Our Programs
VYVGART
\Approvals and Regulatory Plan
VYVGART is approved in more than 30 countries with three active indications (gMG, CIDP and ITP) and three
presentations (IV, SC, PFS). More approvals and launches of VYVGART in multiple jurisdictions and countries are
planned following pricing and reimbursement negotiations. The following table summarizes the status of regulatory
approvals for VYVGART as of February 2026:
Product | Indication | Geography | Regulatory Status | |||||
VYVGART IV | VYVGART | gMG | US | Approved | ||||
VYVGART | gMG | Europe | Approved | |||||
VYVGART | gMG | Canada | Approved | |||||
VYVGART | gMG | Israel | Approved | |||||
VYVGART | gMG | Japan | Approved | |||||
VYVGART | gMG | The UK | Approved | |||||
VYVGART | gMG | China | Approved | |||||
VYVGART | gMG | Australia | Approved | |||||
VYVGART | gMG | Kuwait | Approved | |||||
VYVGART | gMG | Saudi Arabia | Approved | |||||
VYVGART | gMG | Korea (the Republic of) | Approved | |||||
VYVGART | gMG | United Arab Emirates | Approved | |||||
VYVGART | gMG | Switzerland | Approved | |||||
Pending | gMG | Brazil | Submitted | |||||
VYVGART | gMG | Singapore | Approved | |||||
VYVGART | ITP | Japan | Approved | |||||
VYVGART SC | VYVGART HYTRULO | gMG | US | Approved | ||||
VYVGART HYTRULO | CIDP | US | Approved | |||||
VYVGART | gMG | Australia | Approved | |||||
VYVGART | CIDP | Australia | Submitted | |||||
VYVGART | gMG | Europe | Approved | |||||
VYVGART | CIDP | Europe | Approved | |||||
VYVGART | gMG | Switzerland | Approved | |||||
VYVGART | CIDP | Switzerland | Submitted | |||||
VYVGART | gMG | The UK | Approved | |||||
VYVGART | CIDP | The UK | Approved | |||||
VYVGART SC | gMG | Israel | Approved | |||||
VYVGART HYTRULO | gMG | China | Approved | |||||
VYVGART HYTRULO | CIDP | China | Approved | |||||
VYVDURA | gMG | Japan | Approved | |||||
VYVDURA | CIDP | Japan | Approved | |||||
PFS | VYVDURA | gMG | Japan | Approved | ||||
VYVDURA | CIDP | Japan | Approved | |||||
VYVGART HYTRULO | gMG | U.S. | Approved | |||||
VYVGART HYTRULO | CIDP | U.S. | Approved | |||||
VYVGART | gMG | Europe | Approved | |||||
VYVGART | CIDP | Europe | Approved | |||||
VYVGART SC | gMG | Canada | Approved | |||||
VYVGART SC | CIDP | Canada | Approved | |||||
VYVGART | gMG | The UK | Approved | |||||
VYVGART | CIDP | The UK | Approved | |||||
VYVGART | gMG | Australia | Approved | |||||
VYVGART | CIDP | Australia | Submitted | |||||
VYVGART | Switzerland | Submitted | ||||||
VYVGART | gMG | Israel | Submitted | |||||
VYVGART | CIDP | Israel | Submitted |
34
Commercialization
We have established our own sales force in the U.S., Japan, Europe and Canada for VYVGART for the treatment of
gMG and CIDP (where approved). We plan to expand our own sales and marketing capabilities and promote our
products and product candidates in other regions if we decide there is a business case to do so after regulatory approval
has been obtained.
Development and commercialization may also be done through collaborations with third parties. In January 2021, we
entered into an exclusive out-license agreement with Zai Lab (Zai Lab Agreement), a commercial-stage
biopharmaceutical company, for the development and commercialization of efgartigimod in Greater China, (which
includes Mainland China, Hong Kong, Taiwan and Macau, Greater China). Zai Lab announced approval of VYVGART
in Mainland China in June 2023 for the treatment of adult gMG patients and in 2024 Zai Lab also announced the
approval of VYVGART SC for gMG and CIDP. Under the Zai Lab Agreement, we received and continue to be eligible
for certain sales-based milestone payments and royalties based on annual product net sales of efgartigimod in Greater
China.
We intend to continue expanding into new markets and will evaluate the most appropriate commercialization approach
for each territory, whether through our own commercial organization or through additional distribution partnerships.
In the U.S., argenx advertises certain products via digital and traditional media channels, including the internet and
television.
For a discussion of total revenues by geographic market, please see “Note 16 — Segment Reporting” in our consolidated
financial statements which are included in our Annual Report for the period ended December 31, 2025.
Pre-Approval Access Program
We are committed to improving the lives of people suffering from rare diseases. We are driven to discover new
treatment approaches fueled by the resilience of patients to urgently deliver them. We aim to do this in partnership; we
listen to patients, supporters and advocacy communities, and we hear their stories. Their insights guide us as we develop
our investigational therapies and motivate us to advance the understanding of rare diseases.
We have a Pre-Approval Access program (PAA) for patients with gMG which opened on February 21, 2021 for patients
who are unable to participate in an ongoing clinical trial. In 2024, we approved access to this PAA for over 403 gMG
patients in 14 countries. The PAA program remains open in countries where VYVGART is not yet launched or
reimbursed.
efgartigimod (ARGX-113) Development
Mechanism of Action
As shown in Figure 1, efgartigimod is a human IgG1 Fc fragment equipped with our ABDEG™ mutations that is
designed to target the FcRn and reduce IgG. FcRn is foundational to the immune system and functions to recycle IgG,
extending its serum half-life over other IgGs that are not recycled by FcRn. IgGs that bind to FcRn are rescued from
lysosomal degradation. By binding to FcRn, efgartigimod can reduce IgG recycling and increase IgG degradation.
35 | ||
Figure 1: efgartigimod’s mechanism of action blocks the recycling of IgG antibodies and removes them from circulation.
FcRn, neonatal Fc receptor; Ig, immunoglobulin; LDL, low-density lipoprotein.
1) Ulrichts P, et al. J Clin Invest. 2018;128:4372–86
6) Roopenian DC, Akilesh S. Nat Rev Immunol. 2007;7:715–25.
7) Ward ES, Ober RJ. Trends Pharmacol Sci. 2018;39:892–904.
Formulations
Overview
We are developing two formulations of efgartigimod to address the needs of patients, physicians, and payers across
indications and geographies, including efgartigimod IV (VYVGART) and efgartigimod SC (VYVGART SC).
efgartigimod Indications
Clinical trial overview
Clinical Trial | Stage | Indication | Patients | Primary Endpoint | Status | |||||
ADAPT | Registrational | gMG | The proportion of responders based on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score | Marketed | ||||||
ADAPT-SC | Registrational | gMG | The proportion of responders based on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score | Marketed | ||||||
ADAPT- SERON | Registrational | Seronegative gMG | 119 | MG-ADL total score change from baseline to day 29 (w4) | Positive clinical trial results reported in 2025 with expected PDUFA date of May 10, 2026 | |||||
ADAPT- OCULUS | Registrational | Ocular MG | 141 | Change in MGII PRO ocular score from baseline to day 29 (w4) | Positive clinical trial results reported in February 2026 | |||||
ADHERE | Registrational | CIDP | 322 | The hazard ratio for the time to first adjusted INCAT deterioration | Marketed | |||||
ADVANCE- IV | Registrational | ITP | The proportion of patients that achieved sustained platelet response | Marketed |
36 | ||
Clinical Trial | Stage | Indication | Patients | Primary Endpoint | Status | |||||
ADVANCE- NXT | Registrational | ITP | 63 | Extent of disease control (cumulative number of weeks over the planned 24-week treatment period with platelet counts of ≥ 50×109/L | Ongoing clinical trial results expected in 4Q 2026 | |||||
ALKIVIA | Registrational | Myositis | Target 240 | The total improvement score (TIS) at the end of treatment period | Ongoing clinical trial results expected in 3Q 2026 | |||||
UNITY | Registrational | SjD | Target 580 | The change from baseline on the ClinESSDAI score (w48) | Ongoing clinical trial results expected in 2H 2027 | |||||
In partnership with Zai Lab | PoC | LN | Target 60 | The change in urine protein creatinine ratio from baseline to end of the treatment period | Clinical trial discontinued in 2025 | |||||
uplighTED | Registrational | TED | Target 108/ trial | Percentage of participants who were proptosis responders at week 24 | Clinical trial discontinued in 2025 | |||||
shAMRock | PoC | AMR | Target 30 | Safety and tolerability. Efficacy measures such as estimated glomerular filtration rate, histology and urine protein creatinine ratio are captured in the secondary endpoints | Ongoing clinical trial | |||||
ADAPT- JUNIOR IV | Phase 2/3 | gMG | Target over 12 | To confirm an age-adjusted optimum dose of efgartigimod IV and provide (model- predicted) evidence for a treatment response | Ongoing clinical trial | |||||
ADAPT- JUNIOR SC | Phase 2/3 | gMG | Target over 12 | To confirm an appropriate dose of efgartigimod PH20 SC in pediatric participants with gMG | Ongoing clinical trial | |||||
Other clinical trials | PoC | AIE | To be confirmed | Ongoing clinical trial | ||||||
PoC | AIM | To be confirmed | To be confirmed | Ongoing clinical trial |
gMG
Overview
gMG is a rare, chronic autoimmune disease in which pathogenic IgG autoantibodies disrupt neuromuscular signaling,
leading to fluctuating and sometimes life‑threatening muscle weakness. Autoantibodies block or remove acetylcholine
receptors and activate complement, damaging the neuromuscular junction. MG often begins with ocular symptoms such
as ptosis and diplopia, and approximately 85% of patients progress to generalized MG (gMG), which can impair bulbar,
limb, and respiratory function. Respiratory crises occur in 15–20% of patients. MG prevalence in the U.S. is estimated at
approximately 20 per 100,000, and roughly 85% of gMG patients have detectable AChR antibodies.
efgartigimod has demonstrated consistent and robust clinical benefit across MG populations. Pivotal ADAPT data
formed the basis for global approvals of VYVGART IV, and positive ADAPT‑SC results supported approval of the
subcutaneous formulation. In 2025, we reported positive topline results from ADAPT‑SERON, our Phase 3 clinical trial
in anti‑AChR antibody‑negative gMG, demonstrating a clear treatment effect and reinforcing the broad applicability of
FcRn across MG subtypes. These data support our supplemental regulatory submission to expand VYVGART into the
seronegative population, which was accpeted for priority review with an expected PDUFA target action date of May 10,
2026. We also reported positive data from our ADAPT OCULUS clinical trial, which met its primary endpoint, showing
that patients living with oMG and treated with VYVGART demonstrated statistically significant improvement from
baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared
to placebo. The results support our supplemental regulatory submissions to expand VYVGART into the ocular MG
population. We also have ongoing clinical trials in pediatric gMG patients (ADAPT-JUNIOR) with efgartigimod IV and
efgartigimod SC.
37
CIDP
Overview
CIDP is a chronic autoimmune disorder of peripheral nerves and nerve roots caused by an autoimmune-mediated
destruction of the myelin sheath, or myelin producing cells, insulating the axon of the nerves and enabling speed of
signal transduction. The cause of CIDP is unknown, but abnormalities in both cellular and humoral immunity have been
shown. CIDP is a chronic and progressive disease: onset and progression occur over at least eight weeks in contrast with
the more acute Guillain-Barré-syndrome. Demyelination and axonal damage in CIDP lead to loss of sensory and/or
motor neuron function, which can lead to weakness, sensory loss, imbalance and/or pain. The U.S. prevalence is
estimated at approximately 42,000 patients, of whom roughly 24,000 receive treatment. Most patients rely on IVIg as
first‑line therapy, while glucocorticoids, plasma exchange, and other immunosuppressants are used less frequently given
safety, tolerability, and access limitations.
In July 2023, the pivotal ADHERE clinical trial demonstrated that VYVGART SC significantly reduced the risk of
relapse compared to placebo and provided evidence that pathogenic IgG autoantibodies play an important role in CIDP
biology. Sixty‑seven percent of patients entering the open‑label Stage A improved clinically, and efgartigimod SC was
well tolerated with a safety profile consistent with prior clinical trials. Nearly all eligible patients (99%) continued into
the ADHERE‑Plus OLE. Based on these data, VYVGART SC received regulatory approvals in the U.S. in June 2024, in
China in November 2024, and in Japan in December 2024, with regulatory review ongoing in additional jurisdictions,
including the EU.
Primary ITP
Overview
Primary ITP is an acquired autoimmune bleeding disorder, characterized by a low platelet count
(<100×109/L) in the absence of other causes associated with thrombocytopenia. In most patients, IgG autoantibodies
directed against platelet receptors can be detected. They accelerate platelet clearance and destruction, inhibit platelet
production, and impair platelet function, resulting in increased risk of bleeding and impaired quality of life. Primary ITP
is differentiated from secondary ITP, which is associated with other illnesses, such as infections or autoimmune diseases,
or which occurs after transfusion or taking other drugs, such as cancer drugs. Platelet deficiency, or thrombocytopenia,
can cause bleeding in tissues, bruising and slow blood clotting after injury. Patients may suffer from depression and
fatigue as well as side effects of existing therapies, impairing their quality of life. Current therapeutic approaches include
non-specific immunosuppression (e.g., steroids and rituximab), inhibition of platelet clearance (e.g., splenectomy, IVIg,
anti-D globulin, and spleen tyrosine kinase inhibitor fostamatinib13) or stimulation of platelet production (e.g.,
thrombopoietin receptor agonist TPO-RA). Splenectomy remains the only treatment that provides sustained remission
off therapy for one year or longer for a high proportion of patients. ITP affects approximately 72,000 patients in the U.S.
In 2022, the Phase 3 ADVANCE (IV) clinical trial met its primary endpoint, demonstrating that a higher proportion of
chronic ITP patients receiving efgartigimod achieved a sustained platelet count response compared to placebo. These
results supported approval of efgartigimod for ITP in Japan. In 2023, the accompanying subcutaneous clinical trial,
ADVANCE‑SC, did not meet its primary endpoint. To fulfill the requirement for two well-controlled trials needed for
global registration, argenx is now conducting ADVANCE‑NEXT, a Phase 3, randomized, double‑blinded,
placebo‑controlled trial evaluating efgartigimod IV in adults with primary ITP. ADVANCE-NEXT remains ongoing,
with topline Phase 3 results expected in the fourth quarter of 2026.
AIM
Overview
AIM are a rare and heterogeneous group of autoimmune diseases that can affect muscle alone or multiple organ systems,
including the skin, joints, lungs, gastrointestinal tract, and heart. These conditions are severe, disabling, and materially
impact quality of life. Advances in understanding disease biology and the discovery of characteristic autoantibodies have
led to clearer differentiation of AIM into clinically meaningful subtypes, including immune‑mediated necrotizing
myopathy (IMNM), antisynthetase syndrome (ASyS), and dermatomyositis (DM). Each subtype presents with distinct
autoantibody profiles and manifestations, though proximal muscle weakness remains a defining feature across AIM.
Today, there are no FDA‑approved therapies for IMNM or ASyS, and treatment is largely dependent on steroids or
broad immunosuppressants; IVIg was approved for DM in 2021.
argenx is advancing the registrational ALKIVIA clinical trial of efgartigimod SC for the treatment of AIM. ALKIVIA is
a seamless Phase 2/3 clinical trial enrolling approximately 240 patients across IMNM, ASyS, and DM, with Total
Improvement Score (TIS) as the primary endpoint and a broad set of functional and quality‑of‑life secondary measures.
38 | ||
In November 2024, following achievement of statistical significance on the primary endpoint in the Phase 2 portion and
consistent improvement across all six core components of the TIS, argenx announced a ‘GO’ decision to proceed with
the Phase 3 portion in all three AIM subtypes. Safety and tolerability were consistent with the known profile of
efgartigimod. ALKIVIA remains ongoing, with topline Phase 3 results expected in the third quarter of 2026.
SjD
Overview
SjD is a chronic, progressive autoimmune disease, characterized by lymphocytic infiltration and progressive destruction
of exocrine glands. B-cells play a pivotal role in the development of the disease and this results amongst others in
production of IgG autoantibodies, especially those which target SSA/Ro, SSB/La ribonuclear complexes. In addition to
symptoms of dry eyes, dry mouth, chronic pain and fatigue, a substantial subset of patients suffer from extraglandular
systemic disease. There are no FDA-approved treatments currently registered for the treatment of SjD.
argenx is advancing the registrational UNITY clinical trial of efgartigimod SC for the treatment of SjD. UNITY is a
Phase 3, randomized, placebo‑controlled, double‑blind clinical trial assessing the safety and efficacy of efgartigimod SC
in 480 patients with at least moderate systemic disease (ClinESSDAI ≥6) who are on stable background therapy and
positive for anti‑SSA/Ro. After the 48‑week treatment period, eligible participants may roll over into an OLE. The
primary endpoint is change from baseline in clinESSDAI, with key secondary endpoints focused on patient‑reported
outcomes, ESSDAI, and STAR. UNITY remains ongoing, with topline Phase 3 results expected in the second half of
2027.
empasiprubart (ARGX-117) Development
Mechanism of Action
empasiprubart is a differentiated therapeutic mAb targeting C2 equipped with our proprietary NHANCE™ mutations.
By addressing a novel target at the intersection of the complement and lectin pathways of the complement cascade, we
believe empasiprubart represents a broad pipeline opportunity across several severe autoimmune indications. Activation
of the classical and lectin pathway of complement may contribute to tissue damage and organ dysfunction in a number of
autoimmune inflammatory diseases and ischemia-reperfusion conditions. Targeting C2 also leaves the alternative
pathway of the complement system intact, which is an important component of the innate defense system.
empasiprubart exhibits both pH- and calcium dependent binding. These unique characteristics enable empasiprubart to
capture free C2 in circulation and release it in the endosome to be sorted for degradation in the lysosome. empasiprubart
is equipped with NHANCE™ mutations increasing its affinity for FcRn and allowing it to recycle back into circulation
to capture more C2.
In addition to an IV formulation, we have exclusive access to Halozyme’s ENHANZE® SC drug delivery technology for
the C2 target.
39 | ||
Figure 2: empasiprubart mechanism of action. C2, complement component 2; FcRn, neonatal Fc receptor; IgG,
immunoglobulin G.
1) Van de Walle I, et al. J Allergy Clin Immunol. 2021;147:1420–9.
2) Vaccaro C, et al. Proc Natl Acad Sci. 2006;103:18709–14.
3) Brinkhaus M, et al. Nat Commun. 2022;13:6073.
empasiprubart Indications
MMN
Overview
MMN is a debilitating neuromuscular autoimmune disorder that is characterized by slowly progressive muscle weakness
due to motor neuron degeneration. It mainly affects hands and forearms, mainly in males, and the median age of
diagnosis is around 40 years. Diagnosis takes about a year and a half and is often misdiagnosed as ALS. There are
estimated to be around 12,000 patients across key markets.
Specific pathophysiologic characteristics of MMN include the presence of IgM autoantibodies against the ganglioside
GM1 and conduction block, i.e., impaired propagation of action potentials along the axon.
GM1 is widely expressed in the nervous system by neurons, particularly around the nodes of Ranvier, and Schwann
cells.
IVIg is the only approved treatment for MMN and needs to be dosed frequently to address the disease’s progressive
nature.
Phase 2 POC ARDA Clinical Trial
The Phase 2 POC ARDA clinical trial was a randomized, double‑blinded, placebo‑controlled multicenter clinical trial
evaluating the safety and tolerability, efficacy, PK, PD, and immunogenicity of two dose regimens of empasiprubart in
adults with MMN. Safety and tolerability were the primary endpoint and additional endpoints included time to IVIg
retreatment, biomarker analyses of C2 levels, and changes in key functional scores (modified medical research
council‑10 sum score, grip strength, MMN‑RODS) as well as several patient‑reported quality‑of‑life measures (fatigue
severity score (FSS), chronic acquired polyneuropathy patient‑reported index (CAP‑PRI), and patient global impression
change scale). In 2024, argenx announced positive data from the first cohort (n=16), which were confirmed with the
second cohort (n=16) in July 2024, establishing POC in MMN, with empasiprubart demonstrating a 91% reduction in the
need for IVIg rescue compared to placebo [HR (95% CI)=0.09 (0.02; 0.44)] in cohort 1 and an 84% reduction in IVIg
rescue compared to placebo [HR (95% CI)=0.16 (0.02; 1.54)] in cohort 2.
40 | ||
Based on these results argenx initiated the EMPASSION Phase 3 clinical trial evaluating empasiprubart in MMN head to
head with IVIg at the end of 2024.
Phase 3 EMPASSION Clinical Trial Design
A Phase 3, randomized, double-blinded, double-dummy clinical trial evaluating the efficacy and safety
of empasiprubart versus intravenous immunoglobulin in adults with multifocal motor neuropathy. The clinical trial
comprises a screening period of up to 15 weeks, including a minimum of 2 IVIg cycles; a
24-week (6-month), randomized, double-blinded, double-dummy treatment period (part A) evaluating the efficacy and
safety of empasiprubart vs IVIg continuation; a 24-month OLE period (part B); and a 15-month safety follow-up period
starting after the last dose of IMP. The primary objective is to demonstrate the efficacy of empasiprubart compared to
IVIg in improving functional ability. This will be measured by change from baseline in the 25-item MMN-RODS centile
score at week 24. Additional key secondary endpoints include changes in measurements on key functional scores
(modified medical research council -14 sum score, grip strength) as well as patient-reported quality of life outcome
measures (polyneuropathy patient-reported index, and values of the patient global impression change scale and
evaluation of manual dexterity using 9HPT.
DGF
Delayed graft function (DGF), defined as the need for dialysis in the first week after kidney transplant, affects up to 40%
of deceased‑donor recipients and is associated with poorer long‑term outcomes. Decision for Phase 2 VARVARA
clinical trial is now expected mid-year 2026 to complete 52-week efficacy analysis
CIDP
Overview
Please refer to “Item 4.B — efgartigimod Indications” (CIDP) for more information on CIDP.
Phase 3 EMVIGORATE and EMNERGIZE Clinical Trials
argenx is advancing two Phase 3 clinical trials of empasiprubart in CIDP: EMVIGORATE and EMNERGIZE.
EMVIGORATE is a head‑to‑head clinical trial comparing empasiprubart to IVIg in adults with CIDP. EMNERGIZE is a
randomized, placebo‑controlled clinical trial evaluating the efficacy and safety of empasiprubart. Topline results from
both EMVIGORATE and EMNERGIZE are expected in the second half of 2027.
adimanebart (ARGX-119) Development
adimanebart is a humanized agonist monoclonal antibody that specifically targets and activates MuSK to promote
maturation and stabilization of the NMJ, with planned development across severe neuromuscular diseases including
CMS, ALS, and SMA. It is the first highly specific agonist mAb targeting human MuSK and was developed using the
SIMPLE ANTIBODY™ platform in collaboration with leading experts, with preclinical proof‑of‑concept demonstrated
in a DOK7‑CMS model.
A Phase 3 clinical trial in CMS is expected to initiate in the third quarter of 2026, following positive results from the
Phase 1b clinical trial.
A proof-of-concept clinical trial is also ongoing in SMA.
Strategy and Objectives
Company’s Strategies
Our objective is to transform the lives of at least 50,000 patients and their communities before 2030 by providing them
with life-changing medicines built on scientific breakthroughs in immunology. To reach this, we aim to deliver on a set
of different goals:
•Transform the lives of 50,000 patients, by redefining treatment expectations in MG & CIDP and delivering at least
eight additional labeled indications and a second self-administered FcRn medicine by 2030.
41 | ||
•Be the precision complement inhibitor that sets a new SOC and improves patient experience and outcomes across
indications, with 3+ labeled indications and five total indications in development by 2030.
•Be the leader in neuromuscular junction (NMJ) therapeutics, redefining patient expectations and reigniting hope in
one labeled indication and at least four total indications by 2030.
•Expand our pipeline of transformational innovation to enable consistent cadence of value creation for patients; >5
new molecules in late stage by 2030.
•Scale in The argenx Way to remain a unique, independent company.
•Solidify our place in the biotech ecosystem as the benchmark for entrepreneurial science delivering value for patients.
Competitive position
We participate in a highly innovative industry characterized by a rapidly growing understanding of disease biology,
quickly changing technologies, strong intellectual property barriers to entry, and a multitude of companies involved in
the creation, development and commercialization of novel therapeutics. Many of these companies are highly
sophisticated and often strategically collaborate with each other.
Competition in the autoimmune field is intense and involves multiple monoclonal antibodies (mAbs), other biologics and
small molecules either already marketed or in development by many different companies, including large pharmaceutical
companies. We compete with a wide range of biopharmaceutical companies that are developing products for the
treatment of gMG, CIDP, ITP and other autoimmune diseases, including products that are in the same class as
VYVGART, as well as products that are similar to some of our product candidates. We are aware of several FcRn
inhibitors that are in clinical development or marketed.
In addition, we may face future competition from biosimilar versions of approved biologics in the autoimmune and
immunology fields. The regulatory frameworks in the United States, Europe and other key markets could evolve in ways
that may facilitate the entry of biosimilars once reference products lose market exclusivity. While FcRn inhibitors are a
relatively new therapeutic class, the broader biologics market has seen an increase in biosimilar development and
commercial activity, supported by maturing regulatory pathways, expanding manufacturing capabilities and ongoing
payer and health‑system initiatives aimed at reducing the cost of care.
Competitive product launches may erode future sales of our products, including our existing products and those currently
under development, or result in unanticipated product obsolescence. Such launches continue to occur, and potentially
competitive products are in various stages of development. We could also face competition for use of limited
international infusion sites, particularly in new markets as competitors launch new products. We cannot predict with
accuracy the timing or impact of the introduction of competitive products that treat diseases and conditions like those
treated by our products or product candidates. In addition, our competitors compete with us to recruit and retain qualified
scientific and management personnel, establish clinical trial sites and patient registration for clinical trials, as well as in
acquiring technologies complementary to, or necessary for, the development of our products. Please refer to “Item 3.D.
— Risk Factors — Risk Factors Related to Commercialization of argenx's Products and Product Candidates, Including
for New Indications — We face significant competition for our drug discovery and development efforts”
We compete in this dynamic landscape by aiming to advancing differentiated, first‑in‑class and best‑in‑class therapies
grounded in novel biology, enabled by our deep scientific expertise and our technology platforms. Our strategy is to
innovate ahead of the field—identifying new pathways, engineering unique mechanisms of action, and continuously
expanding our understanding of Fc‑mediated biology and related immunology. We also actively protect and strengthen
our intellectual property through a comprehensive global portfolio of patents, trade secrets and proprietary know‑how
covering our product candidates, platforms and manufacturing processes. This commitment to scientific innovation and
robust IP protection is central to sustaining our competitive position and delivering long‑term value.
Manufacturing and Supply
At argenx, our manufacturing and supply strategy is built for scale, resilience, and speed, reflecting our commitment to
move science forward and deliver for patients worldwide. We utilize third-party contract manufacturers who act in
accordance with the FDA’s current good manufacturing practices (cGMPs) for the manufacture of drug substances and
drug products. We partner with a global network of contract manufacturers who share our standards for quality and
innovation, with the goal that every step, from cell bank development to large-scale drug substance production, meets the
highest industry benchmarks. Our global supply chain and distribution strategy is to serve patients in region for that
region. We work with Lonza teams based in Slough, UK, Portsmouth, U.S., Singapore and Visp, Switzerland for
42 | ||
activities relating to the development of cell banks, development of our manufacturing processes and the manufacturing
of drug substance, thereby using validated and scalable systems broadly accepted in our industry. In 2022, we started our
collaboration with FUJIFILM Diosynth Biotechnologies Denmark ApS (Fujifilm) based in Hillerød, Denmark, for
activities relating to the large-scale manufacturing of efgartigimod drug substance. In 2025, we expanded our partnership
with Fujifilm to include new manufacturing site in North Carolina, U.S., strengthening our global supply chain and
supporting anticipated growth in efgartigimod and pipeline assets.
We use additional contract manufacturers to fill, label, package, store and distribute (investigational) drug products.
Intellectual Property
Introduction
We strive to protect and maintain exclusivity for the proprietary technologies that we believe are important to our
patients, business, and shareholders. We continue to pursue and maintain patent protection intended to cover core
platform technologies incorporated into, or used to produce, our product candidates and commercial products. We will
seek protection for our patient innovations in key global jurisdictions. We continue to focus our exclusivity strategies on
all aspects of our assets, including our compositions of matter, methods of use for our approved products, and other
inventions that are important to our business (e.g., the patient innovations described in our product labels/product inserts
and our core manufacturing technologies).
Our intellectual property portfolio continues to grow and keep pace with the innovations arising from our discovery,
development, and commercial efforts. We expect the total volume of patent positions under our management to increase
each year as our pipeline evolves. We currently oversee more than 500 pending applications and granted patents. More
importantly, as we continue to innovate for patients, we will work to protect our patient innovations with new intellectual
property filings to enable future reinvestment for patients.
In addition to patent protection, we rely on trademarks and trade secrets to protect aspects of our business that are not
amenable to, or that we do not consider appropriate for, patent protection, including certain aspects of our llama
immunization and antibody affinity maturation approaches.
Our commercial success depends in part upon our ability to obtain and maintain exclusivity, including regulatory
exclusivities, patent, trade secret, and other proprietary protection for commercially important technologies, inventions
and know-how related to our business. We will defend and enforce our intellectual property rights, particularly our
patent rights, and preserve the confidentiality of our trade secrets while operating without infringing valid and
enforceable intellectual property rights of others. Specifically, we are materially dependent on elements of our
regulatory, patent and other proprietary protection, including certain of those related to our core platform technologies,
described in “Item 4.B. — Business Overview — Intellectual Property — Platform Technologies” below and our product
candidates, as described in “Item 4.B. — Business Overview — Intellectual Property — Our internal Programs” below
The patent positions for biotechnology companies like us are generally uncertain and can involve complex legal,
scientific, and factual issues. In addition, the coverage recited in the claims in a patent application can be significantly
reduced before a patent is issued, and claim scope can be reinterpreted and even challenged after issuance. As a result,
we cannot guarantee that any of our platform technologies and product candidates, or products will be protectable or
remain protected by valid and enforceable patents. We cannot accurately predict whether pending patent applications
will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient
protection from infringing competitors. Any patents we hold may be challenged, circumvented, limited or invalidated by
third parties.
The term of individual patents depends on the patent laws in the countries in which they are obtained. In most countries,
the patent term is 20 years from the earliest date of filing a non-provisional patent application.
In the U.S., the term of a patent covering an FDA-approved drug may be eligible for a limited patent term extension
under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) as compensation for
the loss of patent term during the FDA regulatory review process as described in “Item 4.B. — Business Overview —
Regulation — Licensure and Regulation of Biologics in the U.S.” below. Similar provisions are available in the EU and
in other jurisdictions to extend the term of a patent that covers an approved drug and/or its use. It is possible that issued
U.S. patents covering each of our products/product candidates may be entitled to patent term extensions. If our product
candidates receive FDA approval, we intend to apply for patent term extensions, if available, to extend the term of
patents that cover the approved product candidates and/or their uses. We also intend to seek patent term extensions in
any jurisdictions where available. There is no guarantee that the applicable authorities, including the FDA, will agree
with our assessment of whether such extensions should be granted, and if granted, the length of such extensions.
43
Platform Technologies
With regard to our platform technologies, we own or control intellectual property rights directed to our SIMPLE
ANTIBODY™ discovery platform, the ABDEG™ and NHANCE™ technologies.
With regard to our SIMPLE ANTIBODY™ discovery platform, we have a broad patent portfolio providing exclusivity
on the SIMPLE ANTIBODY™ platform. We expect to enjoy exclusivity under this patent portfolio until between 2029
and 2033.
With regard to the ABDEG™ platform, we co-own the technology with the University of Texas Southwestern Medical
Center and enjoy certain exclusive license rights. We have a broad patent portfolio covering the composition of matter
and uses of certain FcRn antagonists to achieve certain biological effects. A composition of matter patent expires in 2036
in the U.S., whereas in many other countries the base expiry date is 2034.
With regard to the NHANCE™ platform, we exclusively licensed two U.S. patents from the University of Texas
Southwestern Medical Center with composition of matter claims directed to an IgG molecule comprising a variant
human Fc domain, and method of use claims directed to a method of blocking FcRn function in a subject by providing to
the subject such an IgG molecule. The U.S. patents are expected to expire between 2027 to 2028. The patent family also
includes a granted European patent.
Our Internal Programs
efgartigimod
efgartigimod incorporates the ABDEG™ platform technology, for which we co-own the technology with the University
of Texas Southwestern Medical Center and enjoy certain exclusive license rights. We have a broad patent portfolio with
multiple patent families covering the composition of matter and uses of certain FcRn antagonists to achieve disease-
modifying effects. A composition of matter and other relevant patents arising from the same patent family in the U.S.
expire in 2036 and 2037 in Europe whereas in many other countries the base expiry date is 2034. We anticipate several
more patient innovations to evolve during development and commercialization for which we will seek additional patent
protection with later expiration dates.
Our ARGX-109 Product Candidate
With regard to our wholly-owned ARGX-109 product candidate, we have one patent family with composition of matter
claims directed to ARGX-109. The patent family has a base expiry date in 2033. We anticipate several more patient
innovations to evolve during development for which we will seek additional patent protection. Furthermore, ARGX-109
incorporates or employs the SIMPLE ANTIBODY™ platform technology and the NHANCE™ platform technology.
empasiprubart Product Candidate
With regard to the empasiprubart product candidate, we own or have rights to multiple patent families (with several
granted patents and pending patent applications in multiple jurisdictions in North America, South America, the EU and
Asia, directed to composition of matter claims and method of treatment claims. The patent families have base expiry
dates in 2034, 2039 and 2040. We anticipate several more patient innovations to evolve during development for which
we will seek additional patent protection. empasiprubart product candidate incorporates or employs the NHANCE™
platform technology.
adimanebart Product Candidate
With regard to the adimanebart product candidate, we in-licensed patent families from/with New York University
Langone Health, a U.S. medical center based in New York, and additional patent families from/with the Leiden
University Medical Centre, with a U.S. granted patent and several pending applications in multiple jurisdictions . We
anticipate several more patient innovations to evolve during development for which we will seek additional patent
protection.
Our ARGX-118 Product Candidate
With regard to the ARGX-118 product candidate, we co-own a patent portfolio with VIB, an inflammation research
center in Ghent, Brussels, and Ghent University, with one U.S. granted patent and pending patent applications in
multiple jurisdictions in North America, South America, the EU and Asia. The patent family has a base expiry date in
2039.
44
Our Partnered Programs
Our cusatuzumab (ARGX-110) Product Candidate
With regard to the cusatuzumab product candidate, we have a broad patent portfolio that include claims to the
composition of matter, uses of the molecule, and other important inventions. The issued U.S. patents expire in 2032 and
2033, without taking a potential patent term extension into account. cusatuzumab incorporates or employs the SIMPLE
ANTIBODY™ and POTELLIGENT® platform technologies.
Our ARGX-115 (ABBV-151) Product Candidate
With regard to the ARGX-115 (ABBV-151) product candidate that we co-own with, and exclusively license from, the
Ludwig Institute for Cancer Research and UCL, we have a patent portfolio that includes a U.S. patent with a base expiry
date in 2034, without taking a potential patent term extension into account. There is a second family with meaningful
patent coverage to the composition of matter and epitope claims that are expected to expire in 2036 and 2038.
Furthermore, ARGX-115 (ABBV-151) incorporates or employs the SIMPLE ANTIBODY™ platform technology.
Our ARGX-112 (LP-0145) Product Candidate
With regard to the ARGX-112 (LP-0145) product candidate, we have one patent family with composition of matter
claims directed to an antibody that binds human IL-22R. The patent family has a base expiry date in 2037. Furthermore,
ARGX-112 (LP-0145) incorporates the SIMPLE ANTIBODY™ platform technology.
Collaborations and licenses
At argenx, our approach to collaboration and licensing is rooted in the conviction that progress accelerates when
boundaries are challenged and expertise is shared. We follow a disciplined strategy to maximize the value of our
pipeline. We retain full development and commercialization rights for programs where we believe our platform and
capabilities can deliver the greatest impact, ensuring we capture the full value of our innovation. At the same time, we
actively seek out partnerships with organizations that share our drive to redefine what’s possible, leveraging
complementary strengths to unlock new opportunities for patients.
Our licensing strategy is dynamic and pragmatic: we license out select intellectual property to expand the reach of our
science, while we also in-license or acquire technologies and assets that can amplify our pipeline or accelerate
development. We have partnered, and plan to continue to partner, to develop products and product candidates that we
believe have promising utility in disease areas or have patient populations that may benefit from resources of other
biopharmaceutical companies. We believe every agreement is shaped by a clear-eyed focus on execution, mutual benefit,
and the potential to create lasting change. We aim to be disciplined in our diligence and financial commitments, but not
at the expense of agility or ambition. By building alliances that transcend traditional hierarchies and by staying
relentlessly focused on unmet needs, we are not just advancing our own portfolio, we are helping to reshape the
landscape of immunology for the long term.
We also have several license agreements in place, under which we license patents, patent applications and other
intellectual property to third parties. We have also entered into several license agreements under which we license
patents, patent applications and other intellectual property from third parties. License agreements can relate to research
and development and/or commercialization of the relevant product candidates (and technologies) or products. The
licensed intellectual property covers some of our product candidates and some of the antibody engineering technologies
that we use. Some of these licenses impose various diligence and financial payment obligations on us. We expect to
continue to enter into these types of license agreements in the future.
We have entered into multiple collaboration agreements with pharmaceutical partners and license agreements, some of
which are described below.
Our Strategic Partnership with Zai Lab for efgartigimod
Pursuant to the Zai Lab Agreement, Zai Lab obtained the exclusive right to develop and commercialize efgartigimod in
Greater China. Zai Lab will also contribute patients to our global Phase 3 clinical trials of efgartigimod. Our Zai Lab
strategic collaboration allows us to accelerate development of efgartigimod into new autoimmune indications with Zai
Lab taking operational leadership of selected Phase 2 POC Clinical trials.
We are eligible to receive a one-time sales based milestone and tiered royalties based on annual net sales of efgartigimod
in Greater China thereafter.
45
Our Exclusive License with Halozyme for ENHANZE®
In February 2019, we entered into an in-license agreement with Halozyme for the use of certain patents, materials and
know-how owned by Halozyme and relating to its ENHANZE®, for application in the field of prevention and treatment
of human diseases (the ENHANZE® License Agreement). Pursuant to the ENHANZE® License Agreement, we were
granted exclusive rights to apply ENHANZE® to biologic products against pre-specified targets, in order to research,
develop and commercialize SC formulations of our therapeutic antibody-based product candidates.
Our first therapeutic target for which we received an exclusive license from Halozyme was FcRn, which allows us to
apply ENHANZE® to efgartigimod and any other product candidates selective and specific for FcRn. Moreover, the
breadth of our exclusive license to FcRn precludes either Halozyme itself or any of its current or future partners from
utilizing ENHANZE® in the context of an FcRn-targeted product. Our second therapeutic target for which we received
an exclusive license from Halozyme was human C2 associated with the product candidate empasiprubart, which is being
developed to treat severe autoimmune diseases. Pursuant to the ENHANZE® License Agreement, we also have the right
to nominate future targets for an exclusive ENHANZE® license if the target in question has not already been licensed by
Halozyme or is not already being pursued by Halozyme.
We have expanded our collaboration with Halozyme for ENHANZE® drug delivery technology to additional targets for
a total of six, including FcRn and C2.
We may terminate the ENHANZE® License Agreement at any time, either in its entirety or on a target-by-target basis,
by sending Halozyme prior written notice. Absent early termination, the ENHANZE® License Agreement will
automatically expire upon the expiry of our royalty payment obligations under the agreement. In the event the
ENHANZE® License Agreement is terminated for any reason, the license granted to us would terminate but Halozyme
would grant our sublicensees a direct license following such termination. In the event the ENHANZE® License
Agreement is terminated other than for our breach, we would retain the right to sell licensed products then on hand for a
certain period of time post-termination.
Our Exclusive License with the University of Texas for NHANCE™ and ABDEG™
In February 2012, we entered into an exclusive in-license with the Board of Regents of the University of Texas System
(UT BoR) for the use of certain patent rights relating to the NHANCE™ platform for any use worldwide (the UT
Agreement). The UT Agreement was amended on December 23, 2014 to also include certain additional patent rights
relating to the ABDEG™ platform. Upon commercialization of any of our products that use the in-licensed patent rights,
we will be obligated to pay UT BoR a percentage of net sales as a royalty until the expiration of any patents covering the
product. This royalty varies with net sales volume and is subject to an adjustment for royalties we receive from a
sublicensee of our rights under the UT Agreement, but in any event does not exceed 1%. In addition, we must make
annual license maintenance payments to UT BoR until termination of the UT Agreement and we have assumed certain
development and commercial milestone payment and reimbursement obligations. We also have diligence requirements
with respect to development and commercialization of products which use the in-licensed patent rights.
Pursuant to the UT Agreement, we may grant sublicenses to third parties. If we receive any non-royalty income in
connection with such sublicenses, we must pay UT BoR a percentage of such income varying from low-middle single
digits to middle-upper single digits depending on the nature of the sublicense. Such fees are waived if a sublicensee
agrees to pay the milestone payments as set forth in the UT Agreement.
We may unilaterally terminate the UT Agreement for convenience upon prior written notice. Absent early termination,
the UT Agreement will automatically expire upon the expiration of all issued patents and filed patent applications within
the patent rights covered by the UT Agreement. Our royalty payment obligations expire, on a product-by-product and
country-by-country basis, at such time as there are no valid claims covering such product.
OncoVerity for cusatuzumab
In 2022, we, the University of Colorado Anschutz Medical Campus and the University of Colorado Health (UCHealth)
created an asset-centric spin-off, OncoVerity, Inc (OncoVerity), focused on optimizing and advancing the development
of cusatuzumab, a novel anti-CD70 antibody, in acute myeloid leukemia (AML). OncoVerity is an entity of co-creation,
combining the extensive translational biology insights from Dr. Clayton Smith, M.D. from the University of Colorado
with our experience on the CD70/CD27 pathway.
In 2023, we granted an exclusive license for cusatuzumab to OncoVerity and provided, together with a joint venture of
University of Colorado Health and University License Equity Holdings, Inc. on the University of Colorado Anschutz
Medical Campus, and funding for ongoing clinical development of cusatuzumab.
46 | ||
In 2024 and 2025, we participated in a further funding round to support the continued, ongoing, clinical development of
cusatuzumab by OncoVerity.
Our Strategic Partnership with AbbVie for ARGX-115 (ABBV-151)
In 2016, we entered into a collaboration agreement with AbbVie for ARGX‑115 (ABBV‑151), targeting GARP in
oncology (the AbbVie Collaboration Agreement). After completing IND‑enabling work, AbbVie exercised its option
and assumed full responsibility for global development and commercialization. We are eligible for up to $625 million in
potential development, regulatory and commercial milestones, plus tiered royalties from the mid‑single digits to lower
teens. We also retain co‑promotion rights in the EEA and Switzerland. The agreement continues on a product‑by‑product
basis until AbbVie’s payment obligations expire, and AbbVie may terminate the AbbVie Collaboration Agreement with
prior notice.
Trade Secret Protection
In addition to patent protection, we rely on trade secret protection to ensure exclusivity for our proprietary information
that is not amenable to, or that we do not consider appropriate for, patent protection, including, for example, certain
aspects of our llama immunization and antibody affinity maturation approaches. However, trade secrets can be difficult
to protect. Although we take steps to protect our proprietary information, including restricting access to our premises and
our confidential information, as well as entering into agreements with our employees, consultants, advisors and potential
collaborators, third parties may independently develop the same or similar proprietary information or may otherwise gain
access to our proprietary information. As a result, we may be unable to meaningfully protect our trade secrets and
proprietary information.
Regulation
Government authorities in the U.S., at the federal, state and local level, and in the EU and its Member States and other
countries and jurisdictions, extensively regulate, among other things, the research, development, testing, manufacture,
quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing,
post-approval monitoring and reporting, and import and export of pharmaceutical products, including biological
products. In addition, many countries and jurisdictions regulate the pricing of pharmaceutical products. The processes for
obtaining marketing approvals in the U.S. and in other countries and jurisdictions, along with subsequent compliance
with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial personnel
and financial resources, and breach of which can result in enforcement activity under civil, administrative and/or
criminal law.
Licensure and Regulation of Biologics in the U.S.
In the U.S., biological products used for the prevention, treatment, or cure of a disease or condition in a human being are
subject to regulation under the U.S. Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations.
Biologics are approved for marketing under provisions of the Public Health Service Act (PHSA) via biologics license
applications (BLAs).
An applicant seeking approval to market and distribute a new biologic in the U.S. generally must satisfactorily complete
each of the following steps:
•preclinical laboratory tests, animal studies and formulation studies all performed in accordance with applicable
requirements, including the GLPs;
•submission to the FDA of an IND application for human clinical testing, which contains results of the preclinical
tests, together with manufacturing information and analytical data and must become effective before human clinical
trials may begin;
•approval by an institutional review board (IRB) representing each clinical site before each clinical trial may be
initiated;
•performance of adequate and well-controlled human clinical trials to establish the safety, potency and purity of the
product candidate for each proposed indication, in accordance with good clinical practices (GCPs);
•preparation and submission to the FDA of a BLA for a biological product requesting marketing for one or more
proposed indications, including submission of detailed information on the manufacture and composition of the
product in clinical development and proposed labeling;
47 | ||
•one or more FDA inspections of the manufacturing facility or facilities, including those of third parties, at which the
product, or components thereof, are produced to assess compliance with cGMP requirements and to assure that the
facilities, methods and controls are adequate to preserve the product’s identity, potency, quality and purity;
•FDA inspections of the clinical trial sites and/or sponsor to assure compliance with GCPs, and the integrity of clinical
data in support of the BLA;
•payment of user fees and securing FDA approval of the BLA and licensure of the new biological product; and
•compliance with any post-approval requirements, including the potential requirement to implement a risk evaluation
and mitigation strategy (REMS) and any post-approval studies required by the FDA.
Human Clinical Trials in Support of a BLA
Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined. Additional
clinical trials may be required after approval.
•Phase 1 clinical trials are initially conducted in a limited population to test the product candidate for safety, including
adverse effects, dose tolerance, absorption, metabolism, distribution, excretion and PD in healthy humans or, in
patients.
•Phase 2 clinical trials are generally conducted in a limited patient population to identify possible adverse effects and
safety risks, evaluate the efficacy of the product candidate for specific targeted indications and determine dose
tolerance and optimal dosage. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information
prior to beginning larger Phase 3 clinical trials.
•Phase 3 clinical trials are undertaken within an expanded patient population to gather additional information about
safety and effectiveness necessary to evaluate the overall benefit-risk relationship of the drug and to provide an
adequate basis for physician labeling.
A sponsor who wishes to conduct a clinical trial outside the U.S. may, but is not required to, obtain FDA clearance to
conduct the clinical trial under an effective IND. If a foreign clinical trial is not conducted under an IND, the sponsor
may submit data from the clinical trial to the FDA in support of the BLA so long as the clinical trial is well-designed and
well-conducted in accordance with GCPs, including review and approval by an independent ethics committee, and the
FDA is able to validate the clinical trial data through an onsite inspection, if necessary. In some cases, the FDA may
approve a BLA for a product candidate but require the sponsor, or the sponsor may otherwise choose, to conduct
additional clinical trials to further assess, amongst other things, the product candidate’s safety and effectiveness after
approval. Such post-approval clinical trials are typically referred to as Phase 4 clinical trials. Failure to exhibit due
diligence with regard to conducting required Phase 4 clinical trials could result in FDA enforcement, including
withdrawal of approval for products.
Review and Approval of a BLA
The results of product candidate development, preclinical testing and clinical trials, including negative or ambiguous
results as well as positive findings, are submitted to the FDA as part of a BLA requesting a license to market the product.
The BLA also must contain extensive manufacturing information and detailed information on the composition of the
product and proposed labeling as well as payment of a user fee, unless exempt.
The FDA has 60 days after submission of the application to conduct an initial review to determine whether the BLA is
sufficient to file based on the agency’s threshold determination that it is sufficiently complete to permit substantive
review. If the FDA determines the BLA is not sufficiently complete, it will refuse to file the BLA. Once the submission
has been filed, the FDA begins an in-depth review of the application. Under the goals agreed to by the FDA under the
PDUFA, the FDA has 10 months from the filing date in which to complete its initial review of a standard application and
respond to the applicant, and six months from the filing date for an application granted priority review. The FDA does
not always meet its PDUFA goal dates and they may be extended in certain circumstances.
After the FDA’s evaluation of the application and accompanying information, including the results of any necessary
inspections, the FDA will issue an approval letter, or a complete response letter. An approval letter authorizes
commercial marketing of the product with specific prescribing information for specific indications. Under the PHSA, the
FDA may approve a BLA if it determines that the product is safe, pure and potent and the facility where the product will
be manufactured meets standards designed to ensure that it continues to be safe, pure and potent. If the application is not
approved, the FDA will issue a complete response letter, which will identify the deficiencies in the application. Sponsors
that receive a complete response letter may resubmit to the FDA information addressing the issues identified by the
48 | ||
FDA, withdraw the application, or request a hearing. Even if a BLA is resubmitted with data and information addressing
the deficiencies, the FDA may decide that the BLA does not satisfy the criteria for approval.
The FDA may also refer the application to an advisory committee, consisting of independent experts, for review,
evaluation and recommendation as to whether the application should be approved, particularly when applications present
difficult or novel questions of safety or efficacy. The FDA is not bound by the recommendations of an advisory
committee, but it considers such recommendations carefully when making decisions.
If the FDA approves a new product, it may require testing and surveillance programs to monitor the product after
commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms,
including REMS, to help ensure that the benefits of the product outweigh the potential risks. REMS can include
medication guides, communication plans for healthcare professionals, and/or elements to assure safe use. This can
include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under
certain circumstances, special monitoring, and the use of patent registries. The FDA may prevent or limit further
marketing of a product based on the results of post-market studies or surveillance programs.
After approval, many types of changes to the approved product, such as adding new indications, certain manufacturing
changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval.
Expedited Development and Review Programs
The FDA is authorized to designate products meeting certain criteria for expedited development and review programs.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets
the conditions for qualification, or the time period for FDA review or approval may not be shortened.
The FDA may designate a product for fast track review if it is intended, whether alone or in combination with one or
more other products, for the treatment of a serious or life-threatening disease or condition, and demonstrates the potential
to address unmet medical needs for such a disease or condition. For fast track products, sponsors may have more
frequent interactions with the FDA and the FDA may initiate review of sections of a fast track product’s application
before the application is complete (rolling review). The sponsor must also provide, and the FDA must approve, a
schedule for the submission of the remaining information and the sponsor must pay applicable user fees. However, the
FDA’s PDUFA clock for a rolling review application does not begin until the last section of the application is submitted.
A product may be designated as a breakthrough therapy if it is intended, either alone or in combination with one or more
other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that
the product may demonstrate substantial improvement over existing therapies on one or more clinically significant
endpoints, such as substantial treatment effects observed early in clinical development. The FDA may take certain
actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development
process; providing timely advice to the product sponsor regarding development and approval; involving more senior
staff in the review process; assigning a cross-disciplinary project lead for the review team; and taking other steps to
design the clinical trials in an efficient manner. Breakthrough therapy designation also comes with all of the benefits of
fast-track designation.
The FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved,
would provide a significant improvement in safety or effectiveness. The FDA determines, on a case-by-case basis,
whether the proposed product represents a significant improvement when compared with other available therapies.
Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition,
elimination or substantial reduction of a treatment-limiting product reaction, documented enhancement of patient
compliance that may lead to improvement in serious outcomes, or evidence of safety and effectiveness in a new
subpopulation. A priority designation is intended to direct overall attention and resources to the evaluation of such
applications, and to shorten the FDA’s goal for taking action on a marketing application from 10 months to six months
after accepting the application for filing.
The FDA may grant accelerated approval to a product for a serious or life-threatening condition that provides meaningful
therapeutic advantage to patients over existing treatments based upon a determination that the product has an effect on a
surrogate endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured
earlier than an effect on irreversible morbidity or mortality (IMM) and that is reasonably likely to predict an effect on
IMM or other clinical benefit (intermediate clinical endpoint), taking into account the severity, rarity, or prevalence of
the condition and the availability or lack of alternative treatments. Products granted accelerated approval must meet the
same statutory standards for safety and effectiveness as those granted traditional approval.
For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radio-
graphic image, physical sign, or other measure that is thought to predict clinical benefit but is not itself a measure of
clinical benefit. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. An
49 | ||
intermediate clinical endpoint is a measurement of a therapeutic effect that is considered reasonably likely to predict the
clinical benefit of a product, such as an effect on IMM.
The accelerated approval pathway is most often used in settings in which the course of a disease is long and an extended
period of time is required to measure the intended clinical benefit of a product, even if the effect on the surrogate or
intermediate clinical endpoint occurs rapidly. Thus, accelerated approval has been used extensively in the development
and approval of products for treatment of a variety of cancers in which the goal of therapy is generally to improve
survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large
clinical trials to demonstrate a clinical or survival benefit.
The accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, a
post-approval confirmatory clinical trial or studies to verify and describe the product’s clinical benefit. These
confirmatory clinical trials must be completed with due diligence, and the FDA may require that the confirmatory
clinical trial be designed, initiated, and/or fully enrolled prior to, or within a certain period following, approval. The FDA
must also specify the conditions of any required post-approval clinical trial. Sponsors are required to submit progress
reports for required post-approval studies, and the failure to conduct with due diligence a required post-approval clinical
trial, including a failure to meet any required conditions specified by the FDA, or to submit timely reports, are prohibited
acts under the FDCA. Failure to conduct required post-approval studies, or confirm a clinical benefit during post-
marketing studies, would allow the FDA to withdraw the product from the market on an expedited basis. Unless
otherwise informed by the FDA, all promotional materials for product candidates approved under accelerated approval
are subject to prior review by the agency.
Orphan Drug Designation and Exclusivity
Orphan drug designation in the U.S. is designed to encourage sponsors to develop products intended for rare diseases or
conditions. In the U.S., a rare disease or condition is statutorily defined as a condition that affects fewer than 200,000
individuals in the U.S. or that affects more than 200,000 individuals in the U.S. and for which there is no reasonable
expectation that the cost of developing and making available the product for the disease or condition will be recovered
from sales of the product in the U.S. An application for designation as an orphan product can be made any time prior to
the filing of an application for approval to market the product. If the FDA grants orphan drug designation, the generic
identity of the product and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation qualifies
a company for tax credits. Orphan drug designation does not convey any advantage in or shorten the duration of the
regulatory review and approval process.
If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition
for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not
approve any other application to market the same drug for the same indication for seven years from the date of such
approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan
exclusivity by means of greater effectiveness, greater safety or providing a major contribution to patient care, or if the
holder of the orphan exclusivity is unable to supply the market. Competitors, however, may receive approval of either a
different product for the same indication or the same product for a different indication, which could be used off-label in
the orphan indication. Orphan drug exclusivity also could block the approval of one of our products for seven years if a
competitor obtains approval before we do for the same product, as defined by the FDA, for the same indication we are
seeking approval, or if our product is determined to be contained within the scope of the approval of the competitor’s
product for the same indication or disease.
Post-Approval Regulation
If regulatory approval for marketing of a product or new indication for an existing product is obtained, the sponsor will
be required to comply with all post-approval regulatory requirements, including those that the FDA has imposed as part
of the approval process. The sponsor will be required to report certain adverse reactions and production problems to the
FDA, provide updated safety and efficacy information and comply with requirements concerning advertising and
promotional labeling. Manufacturers and other parties involved in the drug supply chain for prescription drug and
biological products must also comply with product tracking and tracing requirements and must notify the FDA of
counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in
the U.S. Manufacturers and certain of their subcontractors are required to register their establishments with the FDA and
certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for
compliance with ongoing regulatory requirements, including cGMPs. Accordingly, the sponsor and its third-party
manufacturers must continue to expend time, money and effort in the areas of production and quality control to maintain
compliance with cGMPs and other regulatory requirements.
A biological product may also be subject to official lot release, meaning that the manufacturer is required to perform
certain tests on each lot of the product before it is released for distribution. If the product is subject to official lot release,
the manufacturer must submit samples of each lot, together with a release protocol showing a summary of the history of
50 | ||
manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot, to the FDA. The FDA may
in addition perform certain confirmatory tests on lots of some products before releasing the lots for distribution. Finally,
the FDA will conduct laboratory research related to the safety, purity, potency and effectiveness of biological products.
Any distribution of biological products and samples must comply with the U.S. Prescription Drug Marketing Act and the
PHSA.
Once approval of a BLA is granted, the FDA may revoke or suspend the approval if compliance with regulatory
requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery
of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with
manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved
labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or
imposition of distribution or other restrictions under a REMS program. FDA also has authority to require post-market
studies, in certain circumstances, on reduced effectiveness of a product and may require labeling changes related to new
reduced effectiveness information. Other potential consequences for a failure to maintain regulatory compliance include,
among other things:
•restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market, or
product recalls;
•fines, untitled letters, or warning letters;
•refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or
revocation of product license approvals;
•product seizure or detention, or refusal to permit the import or export of products; or
•injunctions or the imposition of civil or criminal penalties.
Pediatric Studies and Exclusivity
Under the Pediatric Research Equity Act of 2003, as amended (PREA), certain BLAs or supplements thereto must
contain data that are adequate to assess the safety and effectiveness of the product for the claimed indications in all
relevant pediatric sub-populations, and to support dosing and administration for each pediatric subpopulation for which
the product is safe and effective. Sponsors must also submit an initial Pediatric Study Plan (PSP), within 60 days of an
end-of-Phase 2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or
Phase 2/3 clinical trial. The initial PSPs must contain an outline of the proposed pediatric clinical trial or studies the
applicant plans to conduct, including clinical trial objectives and design, any deferral or waiver requests and other
information required by regulation. The applicant and the FDA must agree upon a final plan. The FDA or the applicant
may request an amendment to the plan at any time.
The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all
pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data
requirements. Unless otherwise required by regulation, PREA does not apply to a biologic for an indication for which
orphan designation has been granted, except that PREA will apply to an original BLA for a new active ingredient that is
orphan-designated if the biologic is a molecularly targeted cancer product intended for the treatment of an adult cancer
and is directed at a molecular target that FDA determines to be substantially relevant to the growth or progression of a
pediatric cancer.
Pediatric exclusivity is another type of non-patent regulatory exclusivity in the U.S. and, if granted for a biologic,
provides for the attachment of an additional six months of protection to the term of any existing regulatory exclusivity
(i.e., reference product exclusivity and orphan drug exclusivity) that has at least 9 months left to expiration. This six-
month exclusivity may be granted if a BLA sponsor submits reports of pediatric studies that fairly respond to a written
request from the FDA for such studies, were conducted in accordance with commonly accepted scientific principles and
protocols, and have been reported in accordance with filing requirements.
Biosimilars and Exclusivity
The Biologics Price Competition and Innovation Act (BPCIA) established a regulatory scheme authorizing the FDA to
approve biosimilars and interchangeable biosimilars.
Under the BPCIA, an applicant may submit an application for licensure of a biologic product that is “biosimilar to” or
“interchangeable with” a previously approved biological product or “reference product.” For the FDA to approve a
biosimilar product, it must find that the proposed biosimilar is highly similar to the reference product notwithstanding
51 | ||
minor differences in clinically inactive components and that there are no clinically meaningful differences between the
product and the reference product in terms of safety, purity, or potency. For the FDA to approve a biosimilar product as
interchangeable with a reference product, the agency must find that the biosimilar product is biosimilar to the reference
product and that it can be expected to produce the same clinical results as the reference product in any given patient, and
(for products administered multiple times) that the biologic and the reference biologic may be alternated or switched
after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to
exclusive use of the reference biologic without such alternation or switch.
Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following
the date of approval of the reference product. The FDA may not approve a biosimilar product until 12 years from the
date on which the reference product was approved. Even if a product is considered to be a reference product eligible for
exclusivity, another company could market a competing version of that product if the FDA approves a full BLA for such
product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to
demonstrate the safety, purity and potency of their product. We note that patent positions may be available to preclude
the introduction into commerce of such competing product independent of any FDA exclusivities. The BPCIA also
created certain exclusivity periods for biosimilars approved as interchangeable products. Products deemed
interchangeable by the FDA may be substituted by pharmacies as dictated by individual state law.
U.S. Patent Term Restoration
Depending upon the timing, duration, and specifics of FDA review and approval of our product candidates, some of our
U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act that permits restoration of
the patent term of up to five years as compensation for patent term lost during the FDA regulatory review process.
Patent-term restoration, however, cannot extend the remaining term of a patent beyond a total of 14 years from the
product’s approval date, and only those claims covering such approved product, a method for using it or a method for
manufacturing it may be extended. The patent-term restoration period is generally one-half the time between the
effective date of an IND and the submission date of a BLA plus the time between the submission date of a BLA and the
approval of that application, except that the review period is reduced by any time during which the applicant failed to
exercise due diligence. Only one patent applicable to an approved biologic is eligible for the extension and the
application for the extension must be submitted within 60 days of approval from FDA and prior to the expiration of the
patent. The U.S. Patent and Trademark Office (USPTO), in consultation with the FDA, reviews and approves the
application for any patent term extension or restoration. In the future, we may apply for restoration of patent term for our
currently owned or licensed patents to add patent life beyond the current expiration date, depending on the expected
length of the clinical trials and other factors involved in the filing of the relevant BLA.
Regulation and Procedures Governing Approval of Medicinal Products in the European Union
Similar to the U.S., the EU comprehensively regulates, among other things, the development, manufacturing, placing on
the market, advertising, distribution, import and export of medicinal products. Particularly, the placing on the market of a
medicinal product for human use in the EU requires a marketing authorization (MA). Main provisions governing
medicinal products in the EU are Directive 2001/83/EC and Regulation (EC) No 726/2004 (each as amended).
Regulation (EC) No 141/2000 and Regulation (EC) No. 847/2000 (each as amended) are also of particular relevance for
orphan medicinal products. While directives need to be transposed into national law by member states of the EU (EU
Member States) before they are applicable, regulations directly apply in the EU Member States once these have been
enacted.
The process governing approval of MA applications (MAA) for the placing on the market of medicinal products in the
EU generally follows the same lines as in the U.S. It entails satisfactory completion of pharmaceutical development, pre-
clinical trials and adequate and well-controlled clinical trials to establish the safety and efficacy of the medicinal product
for each proposed indication. The EU also requires an application for authorization of clinical trials to relevant
competent authorities and the submission of an MAA to the European Medicines Agency (EMA) or to competent
authorities in EU member states and granting of such MA by the European Commission or relevant national authorities
before the medicinal product can be marketed and sold in the EU or the relevant EU Member States. The below
mentioned principles and rules generally apply within the EEA, i.e., the EU including Iceland, Liechtenstein and
Norway.
Clinical Trial Approval
Both non-clinical and clinical data are generally required to support an MAA for a medicinal product in the EU. Non-
clinical investigations are performed to demonstrate the health or environmental safety of new biological substances.
Non-clinical (pharmaco-toxicological) investigations must generally be conducted in compliance with the principles of
good laboratory practice (GLP) as set forth in EU Directive 2004/10/EC (as amended).
52 | ||
Clinical trials are comprehensively regulated in the EU under the Clinical Trials Regulation (EU) No 536/2014 (CTR),
which entered into application on January 31, 2022, and gradually replaced the Clinical Trials Directive 2001/20/EC
(CTD).
As before, many of the CTR’s legal obligations are on the so-called sponsor, which is defined as the individual,
company, institution, or organization that takes responsibility for the initiation, for the management and for setting up the
financing of a clinical trial. The sponsor must obtain an authorization from the competent authority in the EU Member
State(s) in which the clinical trial will be conducted as well as an approval from the competent national ethics committee
in accordance with relevant national legislation in each of the relevant member states, before the commencement of such
clinical trial.
The CTR also imposes requirements, among others, regarding the conduct of a clinical trial (which must be conducted in
accordance with the protocol and good clinical practice to generate acceptable data for MA submission), safety reporting
of adverse events and reactions, changes to clinical trials, protection and informed consent of clinical trial subjects.
Clinical trials conducted outside the EEA must follow the principles set forth in EU legislation if their results are to be
submitted in an MAA in the EU.
Orphan Designation and Exclusivity
Regulations (EC) No. 141/2000 and No. 847/2000 (each as amended) provide that a product can be designated as an
orphan medicinal product by the European Commission if its sponsor can establish: (i) that the product is intended for
the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition, (ii) either (a) the
prevalence of the condition is not more than five in ten thousand persons in the EU when the application is made, or
(b) without incentives it is unlikely that the marketing of the product in the EU would generate sufficient return to justify
the necessary investment in its development and (iii) there exists no satisfactory method of diagnosis, prevention, or
treatment of the condition in question that has been authorized in the EU or, if such method exists, the product has to be
of a significant benefit compared to products available for the condition.
An orphan designation provides a number of benefits, including fee reductions and, regulatory assistance. If an MA is
granted for an orphan medicinal product, this generally results in a ten-year period of market exclusivity for the approved
orphan indication. It is, however, not possible to combine non-orphan and orphan indications within the same MA. Thus,
for non-orphan indications treated with the same active pharmaceutical ingredient, a separate MA has to be sought.
Alternatively, the orphan designation may be waived to allow for the addition of non-orphan indications to an existing
MA. As a result, the approved medicinal product would no longer profit from the orphan designation’s benefits.
During an orphan medicinal product’s market exclusivity period, neither the EMA, the European Commission nor the
EU Member States can accept an application or grant an MA for a “similar medicinal product.” A “similar medicinal
product”, i.e., a medicinal product containing a similar active substance or substances as contained in an authorized
orphan medicinal product, and which is intended for the same therapeutic indication. The market exclusivity period for
the authorized therapeutic indication may, however, be reduced to six years if, at the end of the fifth year, it is
established that the product no longer meets the criteria for orphan designation. For orphan medicinal products intended
for pediatric use, the market exclusivity period may be prolonged by additional two years if they are authorized with a
pediatric indication based on the results from studies conducted under an EMA-approved pediatric investigation plan or
if they are authorized without a pediatric indication but the results of the studies conducted under the EMA-approved
pediatric investigation plan are reflected in the summary of product characteristic and, if appropriate, in the package
leaflet. Market exclusivity may also be revoked in very select cases, such as if (i) it is established that a similar medicinal
product is safer, more effective or otherwise clinically superior; (ii) the MA holder (MAH) for the authorized orphan
medicinal product consents to the second orphan application; or (iii) the MAH for the authorized orphan medicinal
product cannot supply sufficient quantities. Orphan designation must be requested before submitting an MAA and is
reconfirmed during the MAA process. Orphan designation does not convey any advantage in, or shorten the duration of,
the regulatory review and MA approval process.
Marketing Authorization
To obtain an MA for a medicinal product under the EU regulatory framework, an applicant must submit an MAA, either
to the EMA using the centralized procedure or to competent authorities in the EU Member States using the other
procedures (decentralized procedure, national procedure, or mutual recognition procedure). An MA may be granted only
to an applicant established in the EU. Regulation (EC) No. 1901/2006 provides that prior to obtaining an MA in the EU,
an applicant must demonstrate compliance with all measures included in an EMA-approved pediatric investigation plan,
covering all subsets of the pediatric population, unless the EMA has granted a product-specific waiver, class waiver, or a
deferral for one or more of the measures included in the pediatric investigation plan.
The centralized procedure provides for the grant of a single MA by the European Commission that is valid for all EEA
Member States. Pursuant to Regulation (EC) No. 726/2004 (as amended), the centralized procedure is compulsory for
53 | ||
specific products, including for medicines produced by certain biotechnological processes, products designated as
orphan medicinal products, advanced therapy medicinal products (gene therapy, somatic cell therapy or tissue
engineered products) and products with a new active substance indicated for the treatment of certain diseases, including
products for the treatment of cancer and auto-immune diseases and other immune dysfunctions and neurodegenerative
disorders. The centralized procedure is optional for certain other medicinal products.
Under the centralized procedure, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is responsible
for conducting the assessment of a product to define its risk/benefit profile. The CHMP recommendation is then sent to
the European Commission, which adopts a decision binding in all EEA Member States. Under the centralized procedure,
the maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops when additional information
or written or oral explanation is to be provided by the applicant in response to questions asked by the CHMP, which can
considerably extend the 210 days. Accelerated evaluation (150 days excluding clock stops) may be granted by the
CHMP in exceptional cases, when a medicinal product is of major interest from the point of view of public health and, in
particular, from the viewpoint of therapeutic innovation.
MAs have an initial validity for five years, in principle, and they may be renewed after five years on the basis of a
reevaluation of the risk benefit balance by the EMA, or by the competent authority of the EU Member State. Once
renewed, the MA is valid for an unlimited period, unless the European Commission or the competent authority decides,
on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period. Any MA
that is not followed by the placement of the medicinal product on the EU market or on the market of the authorizing EU
Member State(s) within three years after authorization, or if the drug is removed from the market for three consecutive
years, ceases to be valid.
European Data and Market Exclusivity
In the EU, innovative medicinal products, approved on the basis of a complete independent data package, qualify for
eight years of data exclusivity upon MA and an additional two years of market exclusivity (for the more comprehensive
protections applying to orphan medicinal products, please refer to “Item 4.B — Business overview — Orphan
Designation and Exclusivity” above). The data exclusivity, if granted, prevents generic or biosimilar applicants from
referencing the innovator’s preclinical and clinical trial data contained in the dossier of the reference product when
applying for a generic or biosimilar MA in the EU, for a period of eight years from the date on which the reference
product was first authorized in the EU. During the additional two-year period of market exclusivity, a generic or
biosimilar MAA can be submitted, and the innovator’s data may be referenced, but no generic or biosimilar product can
be marketed in the EU until the expiration of the market exclusivity period. The overall ten-year period will be extended
to a maximum of 11 years if, during the first eight years of those 10 years, the MAH obtains an MA for one or more new
therapeutic indications which, during the scientific evaluation prior to their authorization, are determined to bring a
significant clinical benefit in comparison with currently approved therapies. There is no guarantee that a product will be
considered by the EMA to be an innovative medicinal product, and products may not qualify for data exclusivity. Even if
a product is considered to be an innovative medicinal product so that the innovator gains the prescribed period of data
exclusivity, another company nevertheless could also market another version of the product if such company obtained an
MA based on an MAA with a complete independent data package of pharmaceutical tests, preclinical tests and clinical
trials.
Regulatory Requirements after Marketing Authorization
Following MA approval, the MAH is required to comply with a range of requirements applicable to the manufacturing,
marketing, promotion and sale of the medicinal product. These include compliance with the EU’s stringent
pharmacovigilance or safety reporting rules under Directive 2001/83/EC and Regulation (EU) 726/2004 (each as
amended) and the associated guideline on good pharmacovigilance practices (as amended), pursuant to which post-
authorization studies and additional monitoring obligations can be imposed. In addition, the manufacturing of authorized
medicinal products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict
compliance with the principles of good manufacturing practice (GMP) set forth in Commission Directive 2017/1572
GMP and comparable requirements of other regulatory bodies in the EU, which mandate the methods, facilities and
controls used in manufacturing, processing and packing of products to assure their safety and identity. Further, the
wholesale distribution of authorized medicinal products requires a separate distribution license and must be conducted in
strict compliance with good distribution practice standards. Finally, the marketing and promotion of authorized
medicinal products is strictly regulated under Directive 2001/83/EC, (as amended) and as transposed into national laws.
Potential consequences for a failure to maintain regulatory compliance mainly depend on the relevant regulations in the
EU Member States, but are, for example, in Germany, similar to those in the U.S. Please refer to “Item 4.B — Business
overview — Post-Approval Regulations” above.
54
Agreement on new EU Pharmaceutical Legislation
On December 11, 2025, the EU legislative bodies agreed to overhaul, modernize, and streamline the existing general
pharmaceutical legislation, including e.g., Directive 2001/83/EC, as well as Regulations (EC) No. 726/2004, No.
141/2000, or No. 1901/2006 (EU Pharmaceutical Legislation). This agreement is still subject to formal approval by the
European Parliament and the Council of the EU, before being formally adopted. It is expected that the EU
Pharmaceutical Legislation will become applicable in 2028. Although the final text has not yet been published, agreed
key elements appear to include, among others, certain changes to the baseline marketing exclusivity periods, the
streamlining of regulatory procedures as well as a broadening of the so-called “Bolar exemption”, which allows
developers to undertake testing and to prepare for regulatory submissions before patent expiry.
Regulation and Procedures Governing Approval of Medicinal Products in Japan
In order to market any medical products in Japan, a company must comply with numerous and varying regulatory
requirements regarding quality, safety and efficacy in the context, among other things, of clinical trials, marketing
approval, commercial sales and distribution of products. A person who manufactures or markets medical products in
Japan is subject to the supervision of the Ministry of Health, Labour and Welfare (MHLW), primarily under the Act on
Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Pharmaceutical and Medical Devices
Act). This entails the satisfactory completion of pharmaceutical development, preclinical studies and adequate and well-
controlled clinical trials to establish the safety and efficacy of the medical product for each proposed indication. It also
requires the filing of a notification of clinical trials with the Pharmaceuticals and Medical Devices Agency (Japan)
(PMDA) and the obtaining of marketing approval from the relevant authorities before the product can be marketed and
sold in the Japanese market.
Business License
Under the Pharmaceutical and Medical Devices Act, a company or individual must obtain a Marketing Authorization
Holder (MAH) license from the MHLW to engage in the marketing or provision of medical products. This requirement
applies to medical products that are either manufactured by the company itself outsourced to a third party for
manufacturing or imported.
To manufacture medical products for the Japanese market, a company must obtain a manufacturing license from the
MHLW for each production facility. This license is separate from the marketing authorization and is required for both
domestic and foreign manufacturing sites.
Marketing Approval
Under the Pharmaceutical and Medical Devices Act, it is generally required to obtain marketing approval from the
MHLW for the marketing of each medical product. An application for marketing approval must be made through the
PMDA, which implements a marketing approval review.
Clinical Trial
Under the Pharmaceutical and Medical Devices Act, it is required to file notification of clinical trials with the PMDA.
The data of clinical trials and other pertinent data, which must be attached to an application for marketing approval, must
be obtained in compliance with the standards established by the MHLW, such as GLPs and GCPs stipulated by the
ministerial ordinances of the MHLW.
Regulatory Requirements after Marketing Approval
A MAH that has obtained marketing approval for a new pharmaceutical is subject to re-examination by the PMDA for a
specified period after receiving marketing approval. Such re-examination period for VYVGART is stated to be 10 years
after the marketing approval in January 2022. The purpose of this re-examination process is to ensure the safety and
efficacy of a newly approved pharmaceutical by imposing on the MAH the obligation to gather clinical data for a certain
period after the marketing approval was granted to enable the PMDA to re-examine the product. Results of use and other
pertinent data must be attached to an application for a re-examination. An MAH that has obtained a marketing approval
is also required to investigate, among other things, the results of use and to periodically report to the PMDA pursuant to
the Pharmaceutical and Medical Devices Act.
55
Price Regulation
Japan's public medical insurance systems cover virtually the entire Japanese population. The public medical insurance
system, however, does not cover any medical product which is not listed on the National Health Insurance (NHI) price
list published by the Minister of the MHLW. Accordingly, an MAH of medical products must first have a new medical
product listed on the NHI price list to obtain coverage under the public medical insurance system. VYVGART was listed
on the NHI price list in April 2022 and the price was adjusted in February 2024. VYVDURA was listed in April 2024.
The NHI price of a medical product is determined either by price comparison of comparable medical products with
necessary adjustments for innovation, usefulness or size of the market; or, in the absence of comparable medical
products, by the cost calculation method, determined after considering of the opinion of the manufacturer. Prices on the
NHI price list are subject to revision, generally once every year, based on the actual prices at which the medical products
are purchased by medical institutions.
Coverage, Pricing and Reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we may
obtain regulatory approval. Even if our product candidates are approved for marketing, sales of such product candidates
will depend, in part, on the extent to which third-party payors, including government health programs in the U.S. (such
as Medicare and Medicaid), commercial health insurers, and managed care organizations, provide coverage and establish
adequate reimbursement levels for such product candidates. Moreover, increasing efforts by governmental and third-
party payors in the EU, the U.S. and other markets to cap or reduce healthcare costs may cause such organizations to
limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or
provide adequate payment for our product candidates. We expect to experience pricing pressures in connection with the
sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health
maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general,
particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result,
increasingly high barriers are being erected to the entry of new products.
In the U.S. and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the
costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs,
such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Patients are unlikely to
use any product candidates we may develop unless coverage is provided and reimbursement is adequate to cover a
significant portion of the cost of such product candidates.
Factors payors consider in determining reimbursement are based on whether the product is (i) a covered benefit under its
health plan; (ii) safe, effective and medically necessary; (iii) appropriate for the specific patient; (iv) cost-effective; and
(v) neither experimental nor investigational.
The Medicare and Medicaid programs increasingly are used as models for how private payors and other governmental
payors develop their coverage and reimbursement policies for drugs and biologics. Some third-party payors may require
pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers
who use such therapies. It is difficult to predict at this time what third-party payors will decide with respect to the
coverage and reimbursement for our product candidates. No uniform policy for coverage and reimbursement for drug
products exists among third-party payors in the U.S. Therefore, coverage and reimbursement for drug products can differ
significantly from payor to payor including formulary tier placement and utilization management requirements (if any).
As a result, the coverage determination process is often a time-consuming and costly process that will require us to
provide scientific and clinical support for the use of our products to each payor separately, with no assurance that
coverage and adequate reimbursement will be applied consistently or obtained in the first instance. The position of a
product on a formulary generally determines the co-payment that a patient will need to make to obtain the product and
can strongly influence the adoption of a product by patients and physicians. Third-party payors may limit coverage to
specific products on a formulary, which might not include all of the approved products for a particular indication.
Additionally, a payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate
will be approved or that cost-sharing will be acceptable for patients. Coverage policies and third-party reimbursement
rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more of our
products for which we or our collaborators receive marketing approval, less favorable coverage policies and
reimbursement rates may be implemented in the future.
Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of
medical products and services and imposing controls to manage costs, especially drugs when an equivalent generic drug
or a less expensive therapy is available. It is possible that a third-party payor may consider our product candidate and
other therapies (in some cases even off-label treatments) as substitutable and only offer to reimburse patients for the less
expensive product. Even if we show improved efficacy or improved convenience of administration with our product
candidate, pricing of existing drugs may limit the amount we will be able to charge for our product candidate. These
56 | ||
payors may deny or revoke the reimbursement status of a given drug product or establish prices for new or existing
marketed products at levels that are too low to enable us to realize an appropriate return on our investment in product
development. If reimbursement is not available or is available only at limited levels, we may not be able to successfully
commercialize our product candidates and may not be able to obtain a satisfactory financial return on products that we
may develop.
In Mainland China, VYVGART IV has been included in the National Reimbursement Drug List (NRDL) for the
treatment of adults with gMG who are AChR-AB+ after going through price negotiations with the National Healthcare
Security Administration (NHSA) since January 2024, which means that the price of this drug can be (partly) reimbursed
by the social security program of Mainland China for the treatment of this indication in accordance with relevant rules
within certain period. According to the current regulations of Mainland China, if we want our products in addition to
VYVGART IV to be included in the NRDL or want VYVGART to be included in the NRDL for the treatment of other
indications, we will need to go through price negotiations with the NHSA, for which purpose we will likely need to
significantly reduce their prices. Although the inclusion of our products in the NRDL may increase the demand for the
relevant products, our potential revenue from the sales of these products may still decrease as a result of lower prices.
Furthermore, rules and regulations regarding reimbursement change frequently, in some cases at short notice, and we
believe that changes in these rules and regulations are likely. Outside the U.S., we will face challenges in ensuring
obtaining adequate coverage and payment for any product candidates we may develop. Pricing of prescription
pharmaceuticals is subject to governmental control in many countries. In order to secure coverage and reimbursement for
any product that might be approved for sale, we have needed and may need to conduct expensive pharmacoeconomic
studies in order to demonstrate the medical necessity and cost-effectiveness of the product, and the cost of these studies
would be in addition to the costs required to obtain FDA or other comparable marketing approvals. Conducting such
studies could be expensive, involve additional risk and result in delays in our commercialization efforts. Even after
pharmacogenomic studies are conducted, product candidates may not be considered medically necessary or cost-
effective. A decision by a third-party payor not to cover any product candidates we may develop could reduce physician
utilization of such product candidates once approved and have a material adverse effect on our sales, results of
operations and financial condition. Third-party reimbursement and coverage may not be adequate to enable us to
maintain price levels sufficient to realize an appropriate return on our investment in product development. The insurance
coverage and reimbursement status of newly approved products for orphan diseases is particularly uncertain, and failure
to obtain or maintain adequate coverage and reimbursement for any such product candidates could limit our ability to
generate revenue. As noted above, in the U.S., we plan to have various programs to help patients afford our products,
including patient assistance programs and co-pay coupon programs for eligible patients. More specifically, patients can
enroll into MY VYVGART PATH™, a patient support program that provides personalized support from a nurse case
manager and committed support team. In addition to providing support on questions on the treatment and on navigating
the insurance process, the program provides a VYVGART Co-pay Program to eligible patients, aids in referring patients
to charitable foundations that may be able to help with out-of-pocket costs and informs patients of financial assistance
programs that may be available.
The containment of healthcare costs also has become a priority of U.S. federal, state and international governments and
the prices of pharmaceuticals have been a focus in this effort. Governments have shown significant interest in
implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for
substitution of generic products. Net prices for drugs may be reduced by mandatory discounts or rebates required by
government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of
drugs from countries where they may be sold at lower prices than in the U.S. Increasingly, third-party payors are
requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices
charged for medical products. We cannot be sure that reimbursement will be available for any future product candidate
that we commercialize and, if reimbursement is available, the level of reimbursement. In addition, many pharmaceutical
manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price
and best price. Penalties may apply in some cases when such metrics are not submitted accurately and timely. Adoption
of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing
controls and measures, could further limit our potential revenue from the sale of any products for which we may obtain
approval.
The delivery of healthcare in the EU, including the establishment and operation of health services and the pricing and
reimbursement of medicinal products, is almost exclusively governed by national laws, rather than EU legislation.
National governments and health service providers have different priorities and approaches to the delivery of healthcare
and the pricing and reimbursement of products in that context. Therefore, in the EU, pricing and reimbursement schemes
vary widely from EU Member State to another. Some EU Member States provide that products may be marketed only
after a reimbursement price has been agreed. Some EU Member States may require the completion of additional studies
that compare the cost-effectiveness of a particular product candidate to currently available therapies (so called health
technology assessments) in order to obtain reimbursement or pricing approval. EU Member States may approve a
specific price for a product or may instead adopt a system of direct or indirect controls on the profitability of the
company placing the medicinal product on the market. Other EU Member States allow companies to fix their own prices
for products but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions.
57 | ||
Recently, many EU Member States have increased the amount of discounts required on medicinal products and these
efforts could continue as Member States attempt to further manage healthcare expenditures. For example, Germany
introduced a specific discount on certain combination products with new active ingredients. The downward pressure on
healthcare costs in general, particularly medicinal prescription products, has become intense. As a result, increasingly
high barriers are being erected to the entry of new products. Political, economic and regulatory developments may
further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained.
Reference pricing used by various EU Member States and parallel trade (arbitrage between low-priced and high-priced
Member States) can further reduce prices. Special pricing and reimbursement rules may apply to orphan medicinal
products. Inclusion of orphan drugs in reimbursement systems tend to focus on the medical usefulness, need, quality and
economic benefits to patients and the healthcare system as for any drug. Acceptance of any medicinal product for
reimbursement may come with cost, use and often volume restrictions, which again can vary by country. In addition,
results-based rules of reimbursement may apply. There can be no assurance that any EU Member State that has price
controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing
arrangements for any of our products, if approved in those countries. Historically, products launched in the EU do not
follow price structures of the U.S. and generally prices tend to be significantly lower.
The above underlines that, outside the U.S., international operations are generally subject to extensive governmental
price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in
Europe, Canada and other countries has and will continue to put pressure on the pricing and usage of our product
candidates. In many countries, the prices of medical products are subject to varying price control mechanisms as part of
national health systems. Other countries allow companies to fix their own prices for medical products but monitor and
control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the
amount that we are able to charge for our product candidates. Accordingly, in markets outside the U.S., the
reimbursement for our products may be reduced compared with the U.S. and may be insufficient to generate
commercially reasonable revenue and profits.
Government Pricing and Reimbursement Programs for Marketed Drugs in the U.S.
Medicaid, the 340B Drug Pricing Program, and Medicare
Federal law requires that a pharmaceutical manufacturer, as a condition of having its drug and biological products
receive federal reimbursement under Medicaid and Medicare Part B, must pay rebates to state Medicaid programs for all
units of its covered outpatient drugs dispensed to Medicaid beneficiaries and paid for by a state Medicaid program under
either a fee-for-service arrangement or through a managed care organization. This federal requirement is effectuated
through a Medicaid drug rebate agreement between the manufacturer and the Secretary of U.S. Department of Health
and Human Services (HHS). The Centers for Medicare & Medicaid Services (CMS) administers the Medicaid drug
rebate agreements, which provide, among other things, that the drug manufacturer will pay rebates to each state
Medicaid agency on a quarterly basis and report certain price information on a monthly and quarterly basis. The rebates
are based on prices reported to CMS by manufacturers for their covered outpatient drugs, including average
manufacturer price (AMP) and best price. Effective January 1, 2024, the Medicaid total rebate amount is no longer
capped at 100% of a covered outpatient drug’s AMP, which means that a manufacturer could pay a total rebate amount
on a unit of the drug that is greater than the average price the manufacturer receives for the drug.
The terms of participation in the Medicaid drug rebate program impose an obligation to correct the prices reported in
previous quarters, as may be necessary. Any such corrections could result in additional or lesser rebate liability,
depending on the direction of the correction. In addition to retroactive rebates, if a manufacturer were found to have
knowingly submitted false information to the government, federal law provides for civil monetary penalties for failing to
provide required information, late submission of required information, and false information.
A manufacturer must also participate in a federal program known as the 340B drug pricing program in order for federal
funds to be available to pay for the manufacturer’s drug and biological products under Medicaid and Medicare Part B.
Under this program, the participating manufacturer agrees to charge certain safety net healthcare providers no more than
an established discounted price for its covered outpatient drugs. The formula for determining the discounted price is
defined by statute and is based on the AMP and the unit rebate amount as calculated under the Medicaid drug rebate
program, discussed above. Manufacturers are required to report pricing information to the Health Resources and
Services Administration on a quarterly basis. The Health Resources and Services Administration has also issued
regulations relating to the calculation of the ceiling price as well as imposition of civil monetary penalties for each
instance of knowingly and intentionally overcharging a 340B covered entity.
Federal law also requires that manufacturers report data on a quarterly basis to CMS regarding the pricing of drugs that
are separately reimbursable under Medicare Part B. These are generally drugs and biologics, such as injectable products,
that are administered incident to a physician service and are not generally self-administered. The pricing information
submitted by manufacturers is the basis for reimbursement to physicians and suppliers for drugs covered under Medicare
Part B. Under the Inflation Reduction Act (IRA), manufacturers are also required to provide quarterly rebates for certain
58 | ||
single-source drugs and biologics (including biosimilars) covered under Medicare Part B with prices that increase faster
than the rate of inflation. This requirement started on January 1, 2023 for drugs approved on or before December 1, 2020
and begins six quarters after a drug is first marketed for all other drugs. As with the Medicaid drug rebate program,
federal law provides for civil monetary penalties for failing to provide required information, late submission of required
information, and false information.
Additionally, the Infrastructure Investment and Jobs Act added a requirement, effective January 1, 2023, for
manufacturers of certain single-source drugs (including biologics and biosimilars) separately paid for under Medicare
Part B for at least 18 months and marketed in single-dose containers or packages (known as refundable single-dose
containers or single-use package drugs) to provide annual refunds for any portions of the dispensed drug that are unused
and discarded if those unused or discarded portions exceed an applicable percentage defined by statute or regulation.
Manufacturers will be subject to periodic audits and those that fail to pay refunds for their refundable single-dose
containers or single-use package drugs shall be subject to civil monetary penalties.
Medicare Part D provides prescription drug benefits for seniors and people with disabilities. Beginning in 2025, the IRA
eliminates the coverage gap phase and associated manufacturer discounts under Medicare Part D, significantly lowers
the enrollee maximum out-of-pocket cost and establishes a new manufacturer discount program, which requires 10%
discounts in the initial phase, and 20% discounts in the catastrophic phase. Although these discounts represent a lower
percentage of enrollees’ costs than coverage gap discounts, the new manufacturer contribution during the catastrophic
phase could be considerable for certain high-cost drugs and the total contributions by manufacturers to a Part D
enrollee’s drug expenses may exceed those currently provided. The IRA also requires manufacturers to provide annual
Medicare Part D rebates for single-source drugs and biological products with prices that increase faster than the rate of
inflation.
The IRA also allows HHS to directly negotiate the selling price of a statutorily specified number of drugs and biologics
each year that CMS reimburses under Medicare Part B and Part D. Only high-expenditure single-source biologics that
have been approved for at least 11 years (7 years for single-source drugs) can qualify for negotiation, with the negotiated
price taking effect two years after the selection year. In July 2025, Congress expanded the IRA’s orphan drug exclusion
to protect from selection drugs that are indicated only for orphan indications, as well as to extend the time before an
orphan drug may be selected if it is later approved for a non-orphan indication. Negotiations for Medicare Part D
products began in 2023 with the negotiated price taking effect in 2026, and negotiations for Medicare Part B products
will begin in 2026 with the negotiated price taking effect in 2028.
U.S. Federal Contracting and Pricing Requirements
Manufacturers are also required to make their covered drugs, which are generally drugs approved under NDAs or BLAs,
available to authorized users of the Federal Supply Schedule (FSS) of the General Services Administration. The law also
requires manufacturers to offer deeply discounted FSS contract pricing for purchases of their covered drugs by the
Department of Veterans Affairs, the Department of Defense, the Coast Guard, and the Public Health Service (including
the Indian Health Service) in order for federal funding to be available for reimbursement or purchase of the
manufacturer’s drugs under certain federal programs. FSS pricing to those four federal agencies for covered drugs must
be no more than the Federal Ceiling Price (FCP), which is at least 24% below the Non-Federal Average Manufacturer
Price (Non-FAMP) for the prior year. The Non-FAMP is the average price for covered drugs sold to wholesalers or other
middlemen, net of any price reductions.
The accuracy of a manufacturer’s reported Non-FAMPs, FCPs, or FSS contract prices may be audited by the
government. Among the remedies available to the government for inaccuracies is recoupment of any overcharges to the
four specified federal agencies based on those inaccuracies. If a manufacturer were found to have knowingly reported
false prices, in addition to other penalties available to the government, the law provides for significant civil monetary
penalties per incorrect item. Finally, manufacturers are required to disclose in FSS contract proposals all commercial
pricing that is equal to or less than the proposed FSS pricing, and subsequent to award of an FSS contract, manufacturers
are required to monitor certain commercial price reductions and extend commensurate price reductions to the
government, under the terms of the FSS contract Price Reductions Clause. Among the remedies available to the
government for any failure to properly disclose commercial pricing and/or to extend FSS contract price reductions is
recoupment of any FSS overcharges that may result from such omissions.
Healthcare Law and Regulation
Healthcare providers and third-party payors play a primary role in the recommendation and prescription of
pharmaceutical products that are granted marketing approval. Our current and future arrangements with providers,
researchers, consultants, third-party payors and customers are subject to broadly applicable federal and state fraud and
abuse, anti-kickback, false claims, transparency and patient privacy laws and regulations and other healthcare laws and
regulations that may constrain our business and/or financial arrangements. Restrictions under applicable federal and state
healthcare laws and regulations include, without limitation, the following:
59 | ||
•the U.S. federal Anti-Kickback Statute (AKS) prohibits, among other things, persons and entities from knowingly and
willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, in cash or in kind, to induce or
reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good facility,
item, or service, for which payment may be made, in whole or in part, under a federal healthcare program such as
Medicare and Medicaid. This statute has been interpreted to apply to arrangements between pharmaceutical
manufacturers on the one hand and prescribers, purchasers formulary managers and other persons and entities on the
other. Although there are a number of statutory exceptions and regulatory safe harbors protecting certain activities
from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny
or penalty if they do not fully satisfy all elements of an available exception or safe harbor. A person or entity can be
found guilty of violating the AKS without actual knowledge of the statute or specific intent to violate it. In addition,
the government may assert that a claim including items or services resulting from a violation of the AKS constitutes a
false or fraudulent claim for purposes of the federal False Claims Act or federal civil money penalties statute.
Violations of the AKS carry potentially significant civil and criminal penalties, including imprisonment, fines,
administrative civil monetary penalties, and exclusion from participation in federal healthcare programs.
•the U.S. federal false claims and civil monetary penalties laws, including the civil False Claims Act and federal civil
monetary penalty laws, which, among other things, impose criminal and civil penalties, including through civil
whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented,
to the U.S. federal government, claims for payment or approval that are false or fraudulent, knowingly making, using
or causing to be made or used, a false record or statement material to a false or fraudulent claim or obligation to pay
or transmit money to the federal government, or from knowingly making a false statement to avoid, decrease or
conceal an obligation to pay money to the U.S. federal government. In addition, the government may assert that a
claim including items and services resulting from a violation of the AKS constitutes a false or fraudulent claim for
purposes of the False Claims Act. Manufacturers can be held liable under the False Claims Act even when they do not
submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent
claims. The False Claims Act also permits a private individual acting as a “whistleblower” to bring qui tam actions on
behalf of the federal government alleging violations of the False Claims Act and to share in any monetary recovery.
When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil
fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare,
Medicaid and other federal healthcare programs;
•the U.S. federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) which imposes criminal and
civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to
defraud any healthcare benefit program, or obtaining by means of false or fraudulent pretenses, representations, or
promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program,
regardless of the pay (e.g., public or private) or knowingly and willfully falsifying, concealing or covering up a
material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare
benefits, items or services relating to healthcare matters; similar to the AKS, a person or entity does not need to have
actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
•HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH)
and its implementing regulations, and as amended again by the Omnibus Rule in 2013, which imposes certain
obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and
transmission of individually identifiable health information without appropriate authorization by covered entities
subject to the Final HIPAA Omnibus Rule, i.e., certain covered health plans, healthcare clearinghouses and healthcare
providers, as well as their business associates, those independent contractors or agents of covered entities that perform
certain services for or on their behalf involving the use or disclosure of individually identifiable health information.
HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties
directly applicable to business associates and possibly other persons, and gave state attorneys general new authority to
file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’
fees and costs associated with pursuing federal civil actions;
•the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient
Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010
(collectively, the ACA), which requires certain manufacturers of drugs, devices, biologics and medical supplies to
report annually to CMS information related to payments and other transfers of value made by that entity to physicians
(currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician
providers such as physician assistants and nurse practitioners and teaching hospitals, as well as ownership and
investment interests held by physicians and their immediate family members. Failure to submit required information
may result in civil monetary penalties for all payments, transfers of value or ownership or investment interests that are
not timely, accurately, and completely reported in an annual submission;
•federal government price reporting laws, which require us to calculate and report complex pricing metrics in an
accurate and timely manner to government programs;
60 | ||
•federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities
that potentially harm consumers;
•analogous state and local laws and regulations, including: state anti-kickback and false claims laws; state laws that
require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and
the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that
may be made to healthcare providers and other potential referral sources; state and local laws that require the
licensure of sales representatives; state laws that require drug manufacturers to report information related to payments
and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing
information; state laws governing the privacy and security of health information in certain circumstances, many of
which differ from each other in significant ways and may not have the same effect; and state laws related to insurance
fraud in the case of claims involving private insurers; and
•EU, UK and other foreign law equivalents, including reporting requirements detailing interactions with and payments
to healthcare providers and data privacy and security laws and regulations that may be more stringent than those in
the U.S.
State and foreign laws, including for example the EU General Data Protection Regulation (GDPR), also govern the
privacy and security of health information in some circumstances, many of which differ from each other in significant
ways and often are not preempted by HIPAA, thus complicating compliance efforts. There are ambiguities as to what is
required to comply with these state requirements and if we fail to comply with an applicable state law requirement, we
could be subject to penalties.
We have and will continue to spend substantial time and money to ensure that our business arrangements with third
parties comply with applicable healthcare laws and regulations. Recent healthcare reform legislation has strengthened
these federal and state healthcare laws. Because of the breadth of these laws and the narrowness of the statutory
exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge
under one or more of such laws.
Other laws that may affect our ability to operate include:
•the anti-inducement law prohibits, among other things, the offering or giving of remuneration, which includes,
without limitation, any transfer of items or services for free or for less than fair market value (with limited
exceptions), to a Medicare or Medicaid beneficiary that the person know or should know is likely to influence the
beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental
program; and
•European and other foreign law equivalents of each of the laws, including reporting requirements detailing
interactions with and payments to healthcare providers.
In the U.S., to help patients afford our approved product, we may utilize programs to assist them, including patient
assistance programs and co-pay coupon programs for eligible patients. Government enforcement agencies have shown
increased interest in pharmaceutical companies’ product and patient assistance programs, including reimbursement
support services, and a number of investigations into these programs have resulted in significant civil and criminal
settlements. In addition, at least one insurer has directed its network pharmacies to no longer accept co-pay coupons for
certain specialty drugs the insurer identified. Our co-pay coupon programs could become the target of similar insurer
actions. In addition, in November 2013, the CMS issued guidance to the issuers of qualified health plans sold through the
ACA’s marketplaces encouraging such plans to reject patient cost-sharing support from third parties and indicating that
the CMS intends to monitor the provision of such support and may take regulatory action to limit it in the future. The
CMS subsequently issued a rule requiring individual market qualified health plans to accept third-party premium and
cost-sharing payments from certain government-related entities. In September 2014, the Office of the Inspector General
of the HHS issued a Special Advisory Bulletin warning manufacturers that they may be subject to sanctions under the
AKS and/or civil monetary penalty laws if they do not take appropriate steps to exclude Part D beneficiaries from using
co-pay coupons. Accordingly, companies exclude these Part D beneficiaries from using co-pay coupons. Additionally,
certain third-party payors are modifying benefit designs based on the availability of manufacturer cost-sharing assistance
(e.g., copay accumulator or maximizer programs). Following a federal district court decision vacating the provisions of
the 2021 Notice of Benefit and Payment Parameter final rule that provided health plans with discretion whether to
include manufacturer assistance toward the cost-sharing limit, CMS stated its intent to address this issue in future
rulemaking. It is possible that changes in insurer policies regarding co-pay coupons and/or the introduction and
enactment of new legislation or regulatory action could restrict or otherwise negatively affect these patient support
programs, which could result in fewer patients using affected products, and therefore could have a material adverse
effect on our sales, business, and financial condition.
61 | ||
Third-party patient assistance programs that receive financial support from companies have become the subject of
enhanced government and regulatory scrutiny. The Office of the Inspector General of the HHS has established
guidelines that suggest that it is lawful for pharmaceutical manufacturers to make donations to charitable organizations
who provide co-pay assistance to Medicare patients, provided that such organizations, among other things, are bona fide
charities, are entirely independent of and not controlled by the manufacturer, provide aid to applicants on a first-come
basis according to consistent financial criteria and do not link aid to use of a donor’s product. However, donations to
patient assistance programs have received some negative publicity and have been the subject of multiple government
enforcement actions, related to allegations regarding their use to promote branded pharmaceutical products over other
less costly alternatives. Specifically, in recent years, there have been multiple settlements resulting out of government
claims challenging the legality of their patient assistance programs under a variety of federal and state laws. It is possible
that we may make grants to independent charitable foundations that help financially needy patients with their premium,
co-pay, and co-insurance obligations. If we choose to do so, and if we or our vendors or donation recipients are deemed
to fail to comply with relevant laws, regulations or evolving government guidance in the operation of these programs, we
could be subject to damages, fines, penalties, or other criminal, civil, or administrative sanctions or enforcement actions.
We cannot ensure that our compliance controls, policies, and procedures will be sufficient to protect against acts of our
employees, business partners, or vendors that may violate the laws or regulations of the jurisdictions in which we
operate. Regardless of whether we have complied with the law, a government investigation could impact our business
practices, harm our reputation, divert the attention of management, increase our expenses, and reduce the availability of
foundation support for our patients who need assistance.
Violations of these laws or any future enacted laws can subject us to criminal, civil and administrative sanctions
including monetary penalties, damages, fines, disgorgement, individual imprisonment and exclusion from participation
in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and
oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-
compliance with these laws, reputational harm, and we may be required to curtail or restructure our operations.
Moreover, we expect that there will continue to be federal and state laws and regulations, proposed and implemented,
that could impact our future operations and business.
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is
possible that some of our business activities could be subject to challenge under one or more of such laws. Ensuring that
our internal operations and future business arrangements with third parties comply with applicable healthcare laws and
regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business
practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable
fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of the laws
described above or any other governmental laws and regulations that may apply to us, we may be subject to significant
penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from
participation in federal and state healthcare programs, individual imprisonment, reputational harm, and the curtailment or
restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a
corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further,
defending against any such actions can be costly and time-consuming, and may require significant financial and
personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought
against us, our business may be impaired. If any of the physicians or other providers or entities with whom we expect to
do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or
administrative sanctions, including exclusions from government funded healthcare programs and imprisonment. If any of
the above occur, our ability to operate our business and our results of operations could be adversely affected.
Healthcare Reform
In the U.S., the EU and other foreign jurisdictions, there have been a number of legislative and regulatory changes to the
healthcare systems that could affect our future results of operations. In particular, there have been and continue to be a
number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of
healthcare. For example, the ACA, effective since March 2010, is a sweeping law intended to broaden access to health
insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new
transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health
industry and impose additional health policy reforms.
Healthcare reforms that have been adopted, and that may be adopted in the future, could result in further reductions in
coverage and levels of reimbursement for pharmaceutical products, increases in rebates payable under U.S. government
rebate programs and additional downward pressure on pharmaceutical product prices. As discussed above, in August
2022, the IRA was enacted codifying, among other things: a Medicare drug price negotiation program, under which HHS
directly negotiates the selling price of statutorily specified number of Part B and Part D drugs and biologics each year;
inflation rebates which penalizes drug manufacturers that increase prices of Medicare Part B and Part D drugs at a rate
greater than the rate of inflation; and a redesign of the Part D benefit. The IRA permits the Secretary of HHS to
implement many of these provisions through guidance, as opposed to regulation, for the initial years. Manufacturers that
fail to comply with the IRA may be subject to various penalties, including civil monetary penalties. The IRA also
62 | ||
extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan
year 2025. To date, none of the legislative attempts to extend the subsidies has been enacted. These IRA provisions
began taking effect progressively starting in 2023, although certain policies have been subject to legal challenges. For
example, the provisions related to the negotiation of selling prices of high-expenditure single-source drugs and biologics
have been challenged in multiple lawsuits. Additionally, we cannot predict whether the U.S. Congress will further amend
the IRA or if the government will adopt new or different interpretations of the law in future guidance or rulemaking.
However, at this time, the Trump administration is continuing to implement the IRA and to defend the law in litigation.
While it is unclear how the IRA will be implemented in the future and the outcome of the litigation, it will likely have a
significant impact on the pharmaceutical industry.
In addition, the Trump administration has taken several steps to try to align U.S. drug prices with drug prices in other
countries through an approach known as most favored nation (MFN) pricing. For example, on May 12, 2025, the current
Presidential administration published an executive order which, among other actions, instructed HHS to communicate
MFN price targets. The executive order also directed certain steps if “significant progress towards [MFN] pricing . . . is
not delivered.” On July 31, 2025, the U.S. President issued letters to 17 pharmaceutical companies (not including
argenx), calling on those manufacturers and “every manufacturer” to take the following steps within 60 days: extend
MFN pricing to Medicaid for all of their existing drugs; guarantee Medicare, Medicaid, and commercial payors receive
MFN pricing for newly-launched drugs; return increased revenues abroad to American patients and taxpayers; and
participate in direct-to-consumer or direct-to-business distribution models to provide “high-volume, high rebate” drugs at
MFN pricing. Certain manufacturers have entered into direct agreements with the government.
On November 6, 2025, CMS announced the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model
under its Center for Medicare and Medicaid Innovation authority (CMMI). The GENEROUS Model is a voluntary
model that tests the impact of CMS-facilitated supplemental rebate agreements that align the Medicaid net price with a
defined MFN price. In December 2025, CMS issued the Global Benchmark for Efficient Drug Pricing (GLOBE) Model
and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model proposed rules under its Center for Medicare
and Medicaid Innovation authority. The GLOBE and GUARD models would require manufacturers to pay additional
rebates for certain drugs based on the difference between the Medicare price and the price in market basket countries.
CMS proposes that the agency would apply the new rebate requirement to utilization by approximately 25% of Medicare
Part B fee-for-service enrollees (under GLOBE) and 25% of Medicare Part D enrollees (under GUARD). It is uncertain
if these proposed rules will be finalized and if they are, how they will impact our business.
Additionally, in Congress, there are pending legislative proposals that, if enacted, would require MFN pricing in certain
healthcare programs. We cannot predict if any of these legislative proposals will be enacted, how they would be
implemented, and how they could impact our business.
We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit
the amounts that the U.S. federal government will pay for healthcare products and services, which could result in
reduced demand for our product candidates or additional pricing pressures.
Further, legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and
promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be
enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on
the marketing approvals, if any, of our product candidates, may be. In addition, increased scrutiny by the U.S. Congress
of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more
stringent product labeling and post-marketing conditions and other requirements.
Individual states in the U.S. have also become increasingly aggressive in passing legislation and implementing
regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement
constraints, affordability review boards, discounts, restrictions on certain product access and marketing cost disclosure
and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk
purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm
our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and
individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which
suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate
demand for our products or put pressure on our product pricing, which could negatively affect our business, results of
operations, financial condition and prospects.
In international markets, reimbursement and healthcare payment systems vary significantly by country (including across
the EU’s individual member states), and many countries have instituted price ceilings on specific products and therapies.
Future political, economic, and regulatory developments may further affect the ability of pharmaceutical companies to
profitably commercialize current and future products..
63
Environmental Aspects which may Influence the Use of our Material Fixed Assets
Our primary research and development activities take place in our facilities in Zwijnaarde, Belgium. For these activities
we require, and have obtained, the necessary environmental and biohazard permits from the responsible governments,
required by us for the manner in which we use said facilities.
New shares issued during 2025
As a result of the exercise of stock options and vesting of RSUs under our Equity Incentive Plan, 1,122,349 new shares
were created in 2025. Equity Incentive Plan means the equity incentive plan as adopted by our Board of Directors on
December 18, 2014, which was approved by the General Meeting on May 13, 2015, and amended by the General
Meeting on April 28, 2016, and November 25, 2019, and the Board of Directors on December 18, 2019, November 5,
2020, December 15, 2021, on February 27, 2023, on February 28, 2024, on 30 June 2025 and on 4 March 2026
The following table shows the developments in our share capital for the year ended December 31, 2025 and on February
19, 2026:
Number of shares outstanding on December 31, 2023 | 59,194,488 | |
Exercise of stock options | 1,478,225 | |
Vesting of RSUs | 88,244 | |
Number of shares outstanding on December 31, 2024 | 60,760,957 | |
Exercise of stock options | 986,507 | |
Vesting of RSUs | 135,842 | |
Number of shares outstanding on December 31, 2025 | 61,883,306 | |
Exercise of stock options | 179,582 | |
Number of shares outstanding on February 19, 2026 | 62,062,888 |
64
C.ORGANIZATIONAL STRUCTURE
As of December 31, 2025, argenx SE has one subsidiary, argenx BV, which is based in Belgium, and argenx BV has
sixteen subsidiaries. The following table sets out the following information for each of our principal subsidiaries: the
country of incorporation, and percentage ownership and voting interest held by us (directly or indirectly through
subsidiaries).
As per December 31, 2025 | ||||
Name | Country | Participation | ||
argenx SE | the Netherlands | 100% | ||
argenx B.V. | Belgium | 100% | ||
argenx Benelux B.V. | Belgium | 100% | ||
argenx US, Inc. | USA | 100% | ||
argenx Australia Pty. Ltd. | Australia | 100% | ||
argenx Austria Services GmbH | Austria | 100% | ||
argenx Brasil Produtos Farmacêuticos Ltda | Brazil | 100% | ||
argenx Canada Inc. | Canada | 100% | ||
argenx France SAS | France | 100% | ||
argenx Germany GmbH | Germany | 100% | ||
argenx Italy S.r.l. | Italy | 100% | ||
argenx Japan KK. | Japan | 100% | ||
argenx Netherlands Services B.V. | the Netherlands | 100% | ||
argenx Spain S.L. | Spain | 100% | ||
argenx Spain S.L. - Sucursal em Portugal | Portugal | 100% | ||
argenx Switzerland, S.A. | Switzerland | 100% | ||
argenx UK Ltd. | United Kingdom | 100% | ||
Broteio Pharma B.V. | the Netherlands | 100% | ||
The following chart provides an overview of the Group as of the date of this Annual Report. Percentages refer to both
the share of capital and voting rights.
65 | ||
D.PROPERTY, PLANTS AND EQUIPMENT
Our principal executive, operational offices and laboratory space are located in Zwijnaarde, Belgium. In 2024, we added
new office space in Zwijnaarde. The total future cash flows related to these leases are represented below in
“Note 20 — Leases” in our consolidated financial statements which are included to our Annual Report for the period
ended December 31, 2025.
We also lease office space in Amsterdam (the Netherlands), Boston (U.S.), Tokyo (Japan), Geneva (Switzerland),
Munich (Germany), Issy-Les-Moulineaux (France), Vaughan, Ontario (Canada), Gerrards Cross (UK), Milan (Italy),
Madrid (Spain) and Sydney (Australia). In addition, our lease liabilities include a lease plan for company cars with
maturity dates up to four years.
For a discussion of contractual obligations, please see “Note 27 — Commitments” in our consolidated financial
statements which are included to our Annual Report for the period ended December 31, 2025.
We have our principal executive, operational offices and laboratory space located in Zwijnaarde, Belgium. The
following table sets forth our key leased facilities worldwide as of December 31, 2025:
Facility location | Use | Approx. size (m2) | Lease expiry | |||
Zwijnaarde, Belgium (leased) | Operations and Laboratory Space | 5,339 | September 30, 2031 | |||
Zwijnaarde, Belgium (leased) | Office Space | 3,765 | September 30, 2036 | |||
Boston, Massachusetts (leased) | Office Space | 2,379 | August 31, 2030 | |||
Tokyo, Japan (leased) | Office Space | 546 | January 17, 2027 |
Environment, Health and Safety
Our primary research and development activities take place in our facilities in Zwijnaarde, Belgium. For these activities
we require, and have obtained, the necessary environmental and biohazard permits from the responsible governments,
ITEM 4.A.UNRESOLVED STAFF COMMENTS
Not applicable.
66 | ||
ITEM 5.OPERATING AND FINANCIAL REVIEW AND PROSPECTS
The following “Operating and Financial Review and Prospects” should be read together with the information in our
financial statements and related notes included elsewhere in this Annual Report. The following discussion is based on
our financial information prepared in accordance with the IFRS Accounting Standards (IFRS) as issued by the
International Accounting Standards Board (IASB), which may differ in material respects from generally accepted
accounting principles in other jurisdictions, including U.S. GAAP. The following discussion includes forward-looking
statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those
anticipated in these forward-looking statements as a result of many factors, including but not limited to those described
in “Item 3.D. — Risk Factors” and elsewhere in this Annual Report. Please also see “Cautionary Statement Regarding
Forward-Looking Statements in this Annual Report.
A.OPERATING RESULTS
The review of the financial condition and results of operations of certain items from the year ended December 31, 2023,
and year-to-year comparisons between the years ended December 31, 2024 and December 31, 2023 that are not included
in this Annual Report can be found in “Item 5 — Operating and Financial Review and Prospects” of our annual report
on Form 20-F for the year ended December 31, 2024.
Overview
2025 was a transformative year for argenx as we advanced our mission to deliver innovation to patients. Our commercial
execution reached new heights with the successful expansion of VYVGART, the first-in-class FcRn blocker, which now
offers three administration options, including self-injection with the PFS. The PFS launch began in the U.S. in April of
this year, followed by the EU and Japan.
This evolution reflects our commitment to innovating the patient experience in our two blockbuster indications and
pursuing the broadest label for our medicines. The commercialization of the VYVGART franchise generated global
product net sales of $4.2 billion in 2025 as compared to $2.2 billion in 2024.
Beyond commercial achievements, we continued to execute on a pipeline with breadth and depth, reinforcing our
leadership in immunology. We announced positive topline results from the ADAPT SERON clinical trial of VYVGART
in Seronegative gMG, further expanding the potential reach of VYVGART. In December of this year, we filed the
Seronegative gMG supplemental BLA in pursuit of the broadest MG label of any biologic. In January 2026, the FDA
has accepted for priority review a supplemental BLA for VYVGART for the treatment of adults with Seronegative gMG.
The application has been granted an expected PDUFA date of May 10, 2026.
Additionally, we showcased innovation through our R&D webinar highlighting adimanebart (ARGX-119), a first-in-
class agonistic antibody targeting and MuSK to promote maturation and stabilization of the neuromuscular junction, with
advancement inCMS. These programs underscore our strategy of entrepreneurial clinical development and commitment
to addressing unmet needs across a spectrum of autoimmune and neuromuscular diseases.
Looking ahead, in 2026 our teams will strive to continue delivering VYVGART to as many patients as possible. We also
expect results to be delivered on four registrational readouts in 2026 and two more in 2027:
•Topline results expected in the first quarter of 2026 for Ocular MG (ADAPT OCULUS) with efgartigimod
•Topline results expected in the third quarter of 2026 from ALKIVIA clinical trial evaluating three myositis
subsetsIMNM,ASyS and DM with efgartigimod
•Topline results expected in the fourth quarter of 2026 for EMPASSION clinical trial (MMN) with empasiprubart
•Topline results expected in the fourth quarter of 2026 for primary ITP (ADVANCE-NEXT) with efgartigimod
•Topline results from UNITY clinical trial (SjD) expected in second half of 2027 with efgartigimod
•Topline results from EMVIGORATE clinical trial for empasiprubart (CIDP) expected in second half of 2027
Our Vision 2030 sets the goal to have five new molecules in Phase 3, ten labeled indications, and 50,000 patients on
treatment by 2030. It provides a clear roadmap for scaling impact on patients, physicians, and the innovation ecosystem
we’re shaping. Achieving this vision will be driven by our core competencies: building winning molecules,
entrepreneurial clinical development, and delivering a differentiated patient experience. We plan to continue to prioritize
innovation, expand global access, and leverage partnerships to accelerate growth.
67 | ||
On our research and development, we continue towards advancing a deep pipeline of both clinical and preclinical-stage
product candidates for the treatment of severe autoimmune diseases. Leveraging our technology suite, our ecosystem of
partnerships and clinical expertise, we have advanced several candidates into late-stage clinical development, and we
currently have multiple programs in the discovery stage. argenx continues to target one Investigational New Drug (IND)
application per year in generating a world-class pipeline.
We enter the next phase of our ambitious innovation agenda with a solid balance sheet, providing financial strength and
flexibility to invest confidently in our pipeline and global expansion. As of December 31, 2025 and December 31, 2024,
we had cash and cash equivalents amounting to $3.5 billion and $1.5 billion, respectively; in addition to current financial
assets of $0.9 billion and $1.9 billion, respectively.
As outlined in our consolidated financial statements which are included to our Annual Report, total assets of $8.7 billion
as of the year ended December 31, 2025, compared to $6.2 billion as of the year ended December 31, 2024. The main
reason for the material change in balance sheet total is the operational growth of the Company in the period.
For the year ended December 31, 2025 the Company recorded a second year of profitability with
$1.3 billion compared to our first annual profit for the year ended December 31, 2024 in the amount of $0.8 billion. This
was the Company’s first year of operational profitability. As of December 31, 2025, we had accumulated losses of
$0.3 billion.
We expect our expenses to continue to increase as we continue to execute registrational and proof-of-concept studies
across efgartigimod, empasiprubart and adimanebart, as well as the continued investment in our IIP. We anticipate that
our expenses will increase if and as we execute on our research and development activities, pre-commercial and
commercial activities and various other activities.
We are actively engaged in the maintenance, expansion and protection of our intellectual property portfolio, including
litigation costs associated with defending against alleged patent infringement claims or enforcing our IP rights against
third parties. We expect that the costs of development and commercialization might also increase due to current and
future collaborations with research and development partners as well as commercial partners.
Information pertaining to the year ended December 31, 2024 was included in our annual report on Form 20-F for the
year ended December 31, 2024 under “Item 5 — Operating and Financial Review and Prospects’’ which was filed with
the SEC on March 20, 2025.
Basis of presentation
‘‘Section 5 Operating and Financial Review and Prospects’’ should be read in parallel to our consolidated financial
statements and ‘‘Item 3.D Risk factors’’ which are included to our Annual Report for the period ended December 31,
2025.
We specifically, but not exhaustively, indicate the following references to the notes of the financial statements
‘‘Note 2 — Material Accounting Policy Information’’:
•the basis of presentation,
•the material accounting policies, and
•the description of the composition of material accounts, which is further detailed in the notes to the consolidated
financial statements.
68 | ||
Results of Operations
Comparison of Years Ended December 31, 2025 and 2024
Year Ended December 31, | ||||||||
(in thousands of $ except for shares and EPS) | 2025 | 2024 | % Change | |||||
Product net sales | $ | 4,151,316 | $ | 2,185,883 | 90% | |||
Other operating income1) | 96,734 | 66,156 | 46% | |||||
Total operating income | 4,248,050 | 2,252,039 | 89% | |||||
Cost of sales | (450,665) | (227,289) | 98% | |||||
Research and development expenses | (1,364,132) | (983,423) | 39% | |||||
Selling, general and administrative expenses | (1,367,057) | (1,055,337) | 30% | |||||
Loss from investment in a joint venture | (12,390) | (7,644) | 62% | |||||
Total operating expenses | (3,194,244) | (2,273,693) | 40% | |||||
Operating profit/(loss) | $ | 1,053,806 | $ | (21,654) | ||||
Financial income | 163,091 | 157,509 | 4% | |||||
Financial expense | (4,082) | (2,464) | 66% | |||||
Exchange gains/(losses) | 65,792 | (48,211) | (236)% | |||||
Profit for the year before taxes | $ | 1,278,607 | $ | 85,180 | ||||
Income tax benefit | $ | 13,428 | $ | 747,860 | (98)% | |||
Profit for the year | $ | 1,292,035 | $ | 833,040 | 55% | |||
Weighted average number of shares used for basic profit per share | 61,295,149 | 59,855,585 | ||||||
Basic profit per share (in $) | 21.08 | 13.92 | 51% | |||||
Weighted average number of shares used for diluted profit per share | 66,029,215 | 65,177,815 | ||||||
Diluted profit/(loss) per share (in $) | 19.57 | 12.78 | 53% | |||||
1)Comparative figures have been aligned with the presentation adopted in the current period, reflecting the combination of collaboration revenue
and other operating income.
Product Net Sales
Product net sales increased by $2.0 billion to $4.2 billion for the year ended December 31, 2025, compared to
$2.2 billion for the year ended December 31, 2024. Our product net sales have increased in the U.S. and other countries
as the Company continues to execute on the global commercialization of VYVGART and obtain further approvals
worldwide.
Revenue by country arising from the commercial sale of VYVGART is presented under ‘‘Note 16 — Segment
Reporting’’ in our consolidated financial statements which are appended to our Annual Report for the period ended
December 31, 2025.
Other Operating Income
Other operating income increased by $31 million to $97 million for the year ended December 31, 2025, compared to $66
million for the year ended December 31, 2024. The other operating income recognized in the year ended December 31,
2025 was mainly the result of research and development tax incentives, payroll tax rebates and the clinical supply of
product on product net sales of VYVGART in Greater China through Zai Lab.
Other operating income is presented under ‘‘Note 15 — Other Operating Income’’ in our consolidated financial
statements which are appended to our Annual Report for the period ended December 31, 2025.
69 | ||
Research and Development Expenses
Research and development expenses consist principally of:
•external research and development expenses related to (i) chemistry, manufacturing and control costs for our product
candidates, both for preclinical and clinical testing, all of which is conducted by specialized contract manufacturers,
(ii) fees and other costs paid to CROs in connection with preclinical testing and the performance of clinical trials for
our product candidates, (iii) costs associated with regulatory submissions and approvals, QA and pharmacovigilance
and (iv) costs associated with post-approval clinical trials;
•personnel expenses related to compensation of research and development staff and related expenses, including
salaries, benefits and share‑based payment expenses; and
•other expenses.
Our research and development expenses totaled $1.4 billion and $1.0 billion for the years ended December 31, 2025 and
2024, respectively. The increase of $0.4 billion in 2025 as compared to 2024 is primarily driven by an increase in
personnel expenses and external research and development expenses.
Our external research and development expenses for the year ended December 31, 2025 totaled to $0.4 billion, compared
to $0.3 billion for the year ended December 31, 2024. The expenses reflect clinical trial costs and manufacturing
expenses related to the development of our product candidate portfolio.
Personnel expenses relate to internal and external R&D personnel. The expenses also include share-based compensation
expenses related to our research and development employees.
Our research and development expenses may vary substantially from period to period based on the timing of our
research and development activities, including the timing of the initiation of clinical trials, material used in R&D phase
and enrollment of patients in clinical trials. Research and development expenses are expected to increase as we advance
the clinical development of efgartigimod, empasiprubart, adimanebart and further advance the research and development
of our other early-stage pipeline candidates. The successful development of our product candidates is highly uncertain.
At this time, we cannot reasonably estimate the nature, timing and estimated costs of the efforts that will be necessary to
complete the development of, or the period, if any, in which material net cash inflows may commence from any of our
product candidates. This is due to numerous risks and uncertainties associated with developing drugs, as further
described in “Item 3.D. - Risk Factors”.
Research and development expenses are presented under ‘‘Note 17 — Research and Development Expenses’’ in our
consolidated financial statements which are included to our Annual Report for the period ended December 31, 2025.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of:
•personnel expenses related to commercial and enabling functions, as well as their related expenses, including salaries,
benefits and share‑based payment expenses;
•marketing and promotional activities related to the global commercialization of VYVGART;
•professional fees related to commercial and enabling functions;
•Board of Directors expenses consisting of directors’ fees, travel expenses and share-based compensation for non-
executive directors; and
•other expenses.
Our selling, general and administrative expenses totaled $1.4 billion and $1.1 billion for the years ended December 31,
2025 and 2024, respectively. The increase of $0.3 billion for the year ended December 31, 2025 principally resulted
from:
•increased professional and marketing fees, including promotional and marketing costs primarily due to the scaling of
our commercial operations relating to VYVGART;
70 | ||
•increased costs of personnel expenses, related to planned increase in the headcount of our Selling, general and
administrative employees recruited to strengthen our enabling functions and the scaling of our commercial operations
relating to VYVGART; and
•continued investment in our Digital Technology infrastructure.
Selling, general and administrative expenses are presented under ‘Note 18 Selling, General and Administrative
Expenses’’ in our consolidated financial statements which are included to our Annual Report for the period ended
December 31, 2025.
Financial Income and (Expense)
For the year ended December 31, 2025, financial income amounted to $163 million compared to $158 million for the
year ended December 31, 2024. The increase of $6 million in 2025 related primarily to the capital increase of our cash,
cash equivalents, and current financial assets.
B.LIQUIDITY AND CAPITAL RESOURCES
Sources of Funds
Our capitalization is detailed in the “Consolidated Statements of Financial Position” which are included to our Annual
Report for the period ended December 31, 2025. As of December 31, 2025 on an actual basis, the Company had a total
equity amount of $7.3 billion.
Since our inception in 2008, we have invested most of our resources in developing our product candidates, building our
intellectual property portfolio, developing our supply chain, conducting business planning, raising capital and providing
general and administrative support for these operations. December 31, 2024To date, we have funded our operations
through (i) public and private placements of equity securities, (ii) upfront, milestone and expense reimbursement
payments received from our collaborators, (iii) funding from governmental bodies, (iv) proceeds from exercise of
employee stock options and (v) interest income from the investment of our cash and cash equivalents, in addition to
current financial assets. Through December 31, 2025, we have raised gross proceeds of $5.9 billion from private and
public offerings of equity securities.
Our commercial operations have also started to contribute to the funding of our operations based on positive cash flow
from operating activities as of the year ended December 31, 2025.
As we continue to invest in innovation, our cash flows may fluctuate, are difficult to forecast and will depend on many
factors.
We have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect
our liquidity over the next five years, other than leases and commitments as part of our operations, which are detailed in
“Note 27 — Commitments” and “Note 24 — Financial Risk Management” in our consolidated financial statements which
are included to our Annual Report for the period ended December 31, 2025.
For more information as to the risks associated with our future funding needs, see “Item 3.D. — Risk Factors — Risk
For more information as to our financial instruments, please see “Note 24 — Financial Risk Management” in our
consolidated financial statements which are included to our Annual Report for the period ended December 31, 2025.
71
Cash Flows
Comparison for the Years Ended December 31, 2025 and 2024
As of December 31, 2025, the Company had $3.5 billion of cash and cash equivalents compared to
$1.5 billion as of December 31, 2024. The Company’s cash and cash equivalents increased by $2.0 billion year-over-
year mainly resulting from positive cash flow from operating activities and a higher amount of capital held in cash and
cash equivalents as opposed to current financial assets.
The Company’s net cash flow from operating activities increased by $0.8 billion for the year ended December 31, 2025
compared to the year ended December 31, 2024 mainly due to increased product net sales of VYVGART partially offset
by buildup of working capital.
Net cash flow used in investing activities increased by $1.7 billion for the year ended December 31, 2025 compared to
the year ended December 31, 2024 mainly due to the nature of financial instruments held as of the reporting date
classified as cash and cash equivalents coming from capital held in the year as current financial assets. This is partially
offset by payments related to regulatory and sales based milestones to Halozyme.
Net cash flow from financing activities decreased by $47 million for the year ended December 31, 2025 compared to the
year ended December 31, 2024 mainly due to proceeds from the exercise of stock options.
For more information, please see “Consolidated Statements of Cash Flows” and “Note 11 Cash and Cash Equivalents”
in our consolidated financial statements which are included to our Annual Report for the period ended December 31,
2025.
Operating and Capital Expenditure Requirements
We recorded a profit of $1.3 billion for the year ended December 31, 2025. Our operating expenditures are detailed
above in our research and development expenses along with our Selling, general and administrative expenses.
We anticipate that our operating expenses will increase as we intend to continue conducting research and development,
as well as continuing our efforts to expand our sales & marketing and establish our distribution infrastructure. Although
we have generated product net sales of $4.2 billion from global product net sales of VYVGART for the year ended
December 31, 2025, which supports our current profitability, we cannot provide assurances that we will be profitable or
able to sustain net profitability in the future based on these indications alone. Furthermore, we cannot provide any
assurances that we will receive the regulatory approvals to commercialize VYVGART in other indications or in other
countries.
On the basis of current assumptions, we expect that our existing cash and cash equivalents and current financial assets
will enable us to fund our operating expenses and capital expenditure requirements through at least the next twelve
months. The adequacy of our available funds to meet our future operating expenses and capital expenditures will depend
on numerous risks and uncertainties associated with the development and commercialization of efgartigimod and our
other product candidates and discovery stage programs and because the extent to which we may enter into collaborations
with third parties for the development of these product candidates is unknown.
We are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing
the research and development of our product candidates. Our future capital requirements for efgartigimod,
empasiprubart, adimanebart, our other product candidates and discovery stage programs will depend on many factors,
including:
•the progress, timing and completion of preclinical testing and clinical trials for our current or any future product
candidates;
•the number of potential new product candidates we identify and decide to develop;
•the time and costs involved in obtaining regulatory approvals for our product candidates and any delays we may
encounter as a result of evolving regulatory requirements or adverse results with respect to any of our product
candidates;
•selling and marketing activities undertaken in connection with the commercialization of VYVGART or potential
commercialization of any of our current or any future product candidates, if approved, and costs involved in the
creation of an effective sales and marketing organization;
72 | ||
•manufacturing activities undertaken for VYVGART and potential commercialization of any of our current or any
future product candidates, if approved, and costs involved in the creation of an effective supply chain;
•the costs involved in growing our organization to the size needed to allow for the research, development and potential
commercialization of our current or any future product candidates;
•the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims or
infringements raised by third parties;
•the maintenance of our existing collaboration agreements, the entry into new collaboration agreements and the pursuit
of other strategic business development opportunities; and
•developments related to global economic uncertainties and political instability.
For more information as to the risks associated with our future funding needs, see “Item 3.D. — Risk Factors — Risk
Factors — Risk Factors Related to argenx’s Financial Position".
Working capital statement
In our opinion, the working capital of the Company is sufficient for the Company’s present requirements, at least for a
period of 12 months from the date of this Annual Report.
Cash Investment Policy
The Company has adopted a policy whereby cash and cash equivalents and current financial assets are invested with
several highly reputable banks and financial institutions. The main purpose of the Cash Investment Policy is to preserve
the available cash and to ensure sufficient short-term liquidity at all times. Therefore, the Company holds its cash, cash
equivalents and current financial assets mainly with banks which are independently rated A- or higher. Amounts of cash
held with banks rated lower than A- are limited to insignificant balances. The maximum amount and tenor of time
deposits depends on the rating of the counterparty bank. The Company also holds cash equivalents in the form of money
market funds with a low historical volatility. These money market funds are highly liquid investments and can be readily
convertible into a known amount of cash. The Company has adopted a policy whereby money market funds must have a
minimum rating of A of which 95% should have a AAA-rating.
For more information as to our treasury policy and liquidity, please see “Note 24 — Financial Risk Management” in our
consolidated financial statements which are included to our Annual Report for the period ended December 31, 2025.
Off-Balance Sheet Arrangements
During the periods presented we did not have, and we do not currently have, any off‑balance sheet arrangements, as
defined in the applicable rules and regulations, such as relationships with unconsolidated entities or financial
partnerships, which are often referred to as structured finance or special purpose entities, established for the purpose of
facilitating financing transactions that are not required to be reflected on our balance sheets. Our scope of consolidated
entities is disclosed in “Note 29 — Overview of Consolidation Scope” in our consolidated financial statements which are
included to our Annual Report for the period ended December 31, 2025.
C.RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES
For a discussion of our research and development policies, refer to the “Item 4 — Information on the Company” and
D.TREND INFORMATION
Other than as disclosed elsewhere in this Annual Report, we are not aware of any trends, uncertainties, demands,
commitments or events for the current financial period that are reasonably likely to have a material effect on our net
revenues, income, profitability, liquidity, capital resources or prospects, or that caused the disclosed financial
information to be not necessarily indicative of future operating results or financial conditions.
There has been no significant change in the financial performance or the financial position of the Group since the
balance sheet date of December 31, 2025.
73 | ||
For more information, please refer to “Item 4.B — Business Overview”, “Item 5.A. — Operating Results”, “Item 5.B. —
Liquidity and Capital Resources” and “Note 27 — Commitments’’ in our consolidated financial statements which are
appended to our Annual Report for the period ended December 31, 2025.
E.CRITICAL ACCOUNTING ESTIMATES
See “Note 3 — Critical accounting judgments and major sources of estimation uncertainty’’ in our consolidated
financial statements which are appended to our Annual Report for the period ended December 31, 2025.
ITEM 6.DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A.DIRECTORS AND SENIOR MANAGEMENT
Our Board of Directors
As at December 31, 2025, we have a one-tier board structure consisting of 1 Executive Director and
8 Non-Executive Directors, and a Senior Management Team responsible for the day-to-day operations.
Our Board of Directors had 6 formal meetings in the course of 2025.The meetings were held in the months February,
April, May, July, September and November/December. The committees of the Board of Directors also convened
regularly and at least once per quarter.. (Refer to “Item 6.C. — Board Practices — Report Audit and Compliance
Committee”, Item 6.C. — Board Practices — Report Audit and Compliance Committee”, “Item 6.C. — Board Practices
— Report Audit and Compliance Committee”, and “Item 6.C. — Board Practices—Report Audit and Compliance
All Board of Director meetings and 21 out of 24 formal committee meetings were also attended by Tim Van
Hauwermeiren, as executive director. In addition, several members of the Executive Management Team were invited to
discuss specific items included on the Board of Director and committee meetings’ agendas. (please refer to “Item 6.A. —
Set out below is a summary of certain provisions of Dutch corporate law as of the date of this Annual Report, as well as
a summary of relevant information concerning our Board of Directors and certain provisions of our Articles of
Association and the Board By-Laws.
This summary does not purport to give a complete overview and should be read in conjunction with and is qualified in
its entirety by reference to the relevant provisions of Dutch law as in force on the date of this Annual Report, the Articles
of Association and Board By-Laws. The Articles of Association are available in the governing Dutch language and an
unofficial English translation thereof, and the Board By-Laws are available in English, on our website.
74 | ||
The following table sets forth certain information with respect to the current Non-Executive Directors, including their
ages, as of December 31, 2025:
Name | Age | Position | Nationality | Date of Initial Appointment | Date of last (re-) Appointment | Term expiration | ||||||
Tim Van Hauwermeiren | 53 | CEO and executive director | Belgium | July 15, 2008 | May 10, 2022 | AGM 20261) | ||||||
Peter Verhaeghe | 67 | Non-Executive Director (chairperson) | Belgium | October 15, 2008 | May 7, 2024 | AGM 20262) | ||||||
Ana Céspedes | 52 | Non-Executive director | Spain | December 12, 2022 | December 12, 2022 | AGM 2026 | ||||||
James Daly | 64 | Non-Executive Director | U.S. | May 8, 2018 | May 10, 2022 | AGM 2026 | ||||||
Donald deBethizy3) | 75 | Non-Executive Director1) | U.S. | May 13, 2015 | May 2, 2023 | AGM 2025 | ||||||
Pamela Klein | 64 | Non-Executive Director | U.S. | April 28, 2016 | May 7, 2024 | AGM 2026 | ||||||
Brian Kotzin | 77 | Non-Executive Director | U.S. | May 7, 2024 | May 7, 2024 | AGM 2028 | ||||||
Steve Krognes | 57 | Non-Executive Director | U.S. and Norway | February 27, 2023 | February 27, 2023 | AGM 2027 | ||||||
Anthony Rosenberg | 72 | Non-Executive Director1) | UK | April 26, 2017 | May 27, 2025 | AGM 2027 | ||||||
Camilla Sylvest | 53 | Non-Executive director | Denmark | September 8, 2022 | September 8, 2022 | AGM 2026 |
1)Tim Van Hauwermeiren will step down as Executive Director and CEO at the 2026 General Meeting.
2)Peter Verhaeghe will step down as Non-Executive Director and chairperson of the Board of Directors at the 2026 General Meeting.
3)Donald deBethizy retired from the Board of Directors on May 27, 2025. Anthony Rosenberg succeeded him as the vice-chairperson of the Board of Directors.
Peter Verhaeghe
Peter Verhaeghe has served as a member and chairperson of the board of arGEN-X B.V. since October 2008 and as Non-
Executive Director on our Board of Directors since July 2014.
Peter Verhaeghe is the managing partner of VVGB Advocaten-Avocats, a corporate finance law and tax law firm, a
position he has held since July 1999. He is currently lead counsel to a number of Belgian, Dutch, French, U.S. and Swiss
life sciences companies. Peter Verhaeghe has served on the boards of directors of Participatiemaatschappij Vlaanderen
NV since May 2018 and miDiagnostics NV since April 2020. He has also served as chairman of the board of Haretis SA
(Luxembourg) since March 2011 and as chairman of the LP & advisory committee of Bioqube Factory Fund I NV since
September 2020. Peter Verhaeghe previously served as a member of the board of directors of CzechPak Manufacturing
s.r.o., Fujirebio Europe N.V., Tibotec-Virco NV, and Biocartis SA. He was also the president of the board of directors of
Merisant France SAS, a member of the management board of Merisant Company 2 S.à. rl., and chairman of the board of
directors of PharmaNeuroBoost NV. He holds a degree in law from the University of Leuven and an LL.M. degree from
Harvard Law School.
Ana Céspedes
Ana Céspedes has served as a member of our Board of Directors since December 2022 and as the chairperson of the
Remuneration and Nomination Committee since May 2025. Ana Céspedes is the chief executive officer and president of
Vitamin Angels, a global health organization dedicated to addressing malnutrition among women and children
worldwide.
Prior to joining Vitamin Angels, Ana Céspedes served as chief operating officer of the International AIDS Vaccine
Initiative, where she oversaw global operations across the United States, Europe, Africa and India. Her responsibilities
included strategy and business development, access and commercialization, government affairs and external relations,
communications, legal, human resources, finance, administration, business technology, and regional operations. Prior to
that, Ana Céspedes held multiple senior leadership roles at Merck KGaA, most recently as Global Head of Strategy and
75 | ||
External Engagement, Government and Public Affairs. She also worked as a senior consultant at Arthur Andersen. She
currently serves as President of the Scientific Committee of the ProPatiens Institute and has led multiple international
initiatives aimed at strengthening collaboration between the pharmaceutical industry and healthcare systems and
advancing professional capabilities in market access and corporate affairs. She holds a Bachelor’s degree in Pharmacy
and a Ph.D. from the Complutense University of Madrid, a Master in General Management (PDG) from IESE Business
School, and an Executive Certificate in Strategy and Innovation from the Massachusetts Institute of Technology.
She obtained the NACD.DC™ (National Association of Corporate Directors Directorship Certification®) in July 2024.
James Daly
James Daly has served as a member of our Board of Directors since May 2018. James Daly currently also serves as a
director of Acadia Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc. and Cytokinetics, Inc. He was formerly a
member of the board of Halozyme Therapeutics, Inc., Bellicum Pharmaceuticals, Inc. and Chimerix, Inc.
In 1985, he joined GlaxoSmithKline where he held various positions, including senior vice president of the respiratory
division with full responsibility for sales, marketing and medical affairs. James Daly moved to Amgen Inc. in 2001
where he was senior vice president for the North America commercial operations until 2011. In 2012, he joined Incyte
Corp, a publicly-traded company focused on oncology and inflammation, where he was chief commercial officer until
June 2015. Mr. Daly holds a Bachelor’s of Science and an MBA from the University at Buffalo, State University of New
York.
Pamela Klein
Pamela Klein has served as a member of our Board of Directors since April 2016.
Since 2008, Pamela Klein has been a principal and founder of PMK BioResearch, a company offering strategic
consulting in oncology drug development to corporate boards, management teams and the investment community. She
has also been a venture partner in Ysios Capital Partners, SGIEC, S.A.U. since 2023. She currently serves as a member
of the board of directors of several companies including Shasqi, Frontier Medicines Corp and Ona Therapeutics.
Previously, Pamela Klein served on the board of directors of FStar, Sardona Therapeutics, Patrys Therapeutics, Inc, Jiya
Acquisition Corp, and Spring Bank Pharmaceuticals, Inc. until its merger with F-Star Therapeutics in July 2020. Pamela
Klein previously spent seven years at the National Cancer Institute as research director of the NCI-Navy Breast Center,
after which she joined Genentech as vice president of development until 2001. She also served as chief medical officer
for Intellikine, Inc., which was acquired by Takeda American Holdings. She holds a Bachelor’s degree in biology from
California State University and an M.D. from Stritch School of Medicine, Loyola University Chicago and is trained in
internal medicine and medical oncology.She continues to serve as an advisor for both private and public biotech
companies.
Brian Kotzin
Brian Kotzin has served as a member of our Board of Directors and as a chairperson of our research and development
committee since May 7, 2024.
He is a former member of the board of directors at Vera Therapeutics, Inc., Rigel Pharmaceuticals, Inc. and Kyverna
Therapeutics, Inc. He served as Senior Vice President for Nektar Therapeutics, Inc. from April 2017 to June 2023, and
has held various leadership positions at Nektar Therapeutics, Inc., including serving as Chief Medical Officer and Head
of Clinical Development from January 2021 to September 2021, again from May 2022 to June 2023, and again from
February 2025 to November. He currently is the interim chief medical officer at Nektar Therapeutics, Inc. From 2004 to
2015, Brian Kotzin was Vice President, Global and Clinical Development and Head, Inflammation Therapeutic Area at
Amgen Inc., directing the global development efforts for product candidates in the inflammation area. During his
employment at Amgen Inc, he also served as Vice President of Translational Sciences and Head of Medical Sciences
from 2006 to 2011. Prior to entering the life sciences industry, Brian Kotzin held several positions as a professor at the
University of Colorado Health Sciences Center, where his research focused on immunopathogenesis of inflammatory
diseases. He has also held leadership roles at several national organizations, including as a member of the American
College of Rheumatology (ACR) Board of Directors, Member and Chairperson of the NIH Immunological Sciences
Study Section, Chairperson of the NIH Autoimmunity Centers of Excellence, and Member of the Board of Directors for
the Federation of Clinical Immunology Societies. He is currently an elected Master of the ACR. He received an M.D.
from Stanford University and a Bachelor’s degree in mathematics from the University of Southern California.
Steve Krognes
Steve Krognes has served as a member of our Board of Directors and as a chairperson of our Audit and Compliance
Committee since February 2023.
76 | ||
Steve Krognes also serves on the boards of directors of Guardant Health, Inc., Denali Therapeutics, Inc., and Pliant
Therapeutics, Inc. In September 2023, he also was appointed to the board of directors of ClayvstBio and in March 2026
he was appointed to the Board of Alveus Therapeutics Inc. He previously served on the boards of directors of RLS
Global AB and Corvus Pharmaceuticals, Inc. and Gritstone Bio, Inc. Steve Krognes was the chief financial officer of
Denali Therapeutics, Inc. from 2015 until retiring from that position in April 2022. Steve Krognes led successful
financings for Denali Therapeutics, Inc., including its initial public offering in 2017, and contributed significantly to the
company’s strategy, growth and strong financial position. His extensive leadership experience in the biotech and
pharmaceutical industries includes 12 years in total at Roche and Genentech, Inc., during which Steve Krognes served as
chief financial officer of Genentech, Inc. for six years and global head of Roche’s mergers & acquisition team for six
years. He also chaired the Genentech Access to Care Foundation and represented Genentech on the board and executive
committee of the California Life Science Association. Before that, Steve Krognes worked as an investment banker at
Goldman Sachs, as a management consultant at McKinsey & Company, and as a venture capitalist in Scandinavia. Mr.
Krognes holds a Master’s of Business Administration (MBA) from Harvard Business School and a Bachelor’s of
Science in economics from the Wharton School of the University of Pennsylvania.
Anthony Rosenberg
Anthony Rosenberg has served as a member of our Board of Directors since April 2017 and as vice-chairperson of our
Board of Directors since May 2025.
He currently serves as chief executive officer of TR Advisory Services GmbH, his own consultancy firm advising on
business development, licensing, and mergers and acquisitions. Anthony Rosenberg also currently serves as chairman of
the boards of directors of NUCLIDIUM AG, Oculis SA and Cullinan Therapeutics Inc. Previously Anthony Rosenberg
held the positions of Managing Director at MPM Capital, a venture capital firm (2015 until 2020); head of M&A and
Licensing of Novartis International (2013 to 2015); and head of business development and licensing at Novartis Pharma
(2005 to 2012). Anthony Rosenberg also previously served on the boards of directors of SiO2 Material Science (until
March 2023), Radius Health Inc., TriNetX, Inc., iOmx Therapeutics AG, and Clinical Ink, Inc. Mr. Rosenberg has a
Bachelor of Science with honors from the University of Leicester and a Master’s of Science in physiology from the
University of London..
Camilla Sylvest
Camilla Sylvest has served as a member of our Board of Directors since September 2022. Camilla Sylvest previously
served as the executive vice president of commercial strategy and corporate affairs of Novo Nordisk A/S until April
2025.
Camilla Sylvest has more than 29 years of working experience at Novo Nordisk A/S during which time she was based in
Switzerland, Denmark, Germany, Malaysia, and Mainland China. Over the years, Camilla Sylvest has headed up Novo
Nordisk A/S affiliates of growing size and complexity in Europe. She was also corporate vice president of the business
area Oceania and Southeast Asia and senior vice president and general manager of the Novo Nordisk A/S region of
Mainland China. Camilla Sylvest also served as a member of the board of Danish Crown A/S until September 2025. She
holds a Master’s of Science in economics from the University of Southern Denmark and an executive MBA from the
Scandinavian Management Institute.
Attendance Record Board of Director Meetings
In 2025, 6 Board of Directors meetings were held. The meeting attendance rate for our directors is set out in the table
below.
77 | ||
Name | Number of meetings attended in 2025 since appointment (and up to resignation, as applicable) | Attendance % | ||
Peter Verhaeghe | 6 | 100% | ||
Tim Van Hauwermeiren | 6 | 100% | ||
Steve Krognes | 6 | 100% | ||
Donald deBethizy1) | 3 | 100% | ||
Pamela Klein | 6 | 100% | ||
Anthony Rosenberg (vice-chairperson) | 6 | 100% | ||
James Daly | 6 | 100% | ||
Camilla Sylvest | 6 | 100% | ||
Ana Céspedes | 6 | 100% | ||
Brian Kotzin | 6 | 100% |
1)Donald deBethizy retired from the Board of Directors on May 27, 2025.
In 2025, all of the 5 Board of Directors meetings with the Non-Executive Directors being present were held as closed
sessions at the beginning or the end of other meetings. These meetings were attended by all Non-Executive Directors
appointed at such time.
Name | Number of meetings attended in 2025 since appointment (and up to resignation, as applicable) | Attendance % | ||
Peter Verhaeghe | 5 | 100% | ||
Donald deBethizy1) | 3 | 100% | ||
Pamela Klein | 5 | 100% | ||
Anthony Rosenberg | 5 | 100% | ||
James Daly | 5 | 100% | ||
Camilla Sylvest | 5 | 100% | ||
Ana Céspedes | 5 | 100% | ||
Brian Kotzin | 5 | 100% |
1)Donald deBethizy retired from the Board of Directors on May 27, 2025
Activities
The agenda for the Board of Directors centers around the key business objectives for long-term value creation and the
key risks involved, as well as the manner in which the Executive Management Team implements our strategy including
our research and development pipeline and the commercialization of our products, our culture to ensure proper
monitoring by the Non-Executive Directors, our financial position as well as the results of our subsidiaries, significant
investment proposals, yearly budgets, the internal risk management and control system, talent development, succession
planning and remuneration and appointment matters.
In 2025, the Board of Directors discussed a multitude of different themes. The Board of Directors primarily supervised
and discussed the Company's innovation mission and objectives towards our long-term strategic Vision 2030, reviewed
the scientific pipeline and regulatory developments for all product candidates in several geographies, ensuring the
required progression thereof. The Board of Directors furthermore reviewed and discussed our strategy for manufacturing
processes, our supply chain and identified potential corresponding risks following the geopolitical environment. The
Board also focused on the commercialization strategies and opportunities, contributing to our successful product
launches, including the launch of the PFS in 2025, supporting innovation within commercialization efforts. The Board
spent a significant amount of time on themes around cybersecurity and AI, including on NIS2 Directive requirements. In
line with previous years, the Board of Directors also discussed talent development and succession planning, both for the
senior leaders within the Company (within and beyond the Executive Management Team) and the Board of Directors.
This led to the renewal of the appointment of Anthony Rosenberg as Non-Executive Director and the attraction of
several new members in the Company’s broader leadership team. Time was also spent discussing and evaluating the
Company's strategy surrounding the continued rapid growth and the measures undertaken to preserve our unique
company culture. Finally, the Board of Directors spent a lot time discussing shareholder feedback on our journey on
getting the remuneration policy approved during the 2025 Extraordinary General Meeting.
78 | ||
Our Senior Management
The following table sets forth certain information with respect to the members of our Senior Management Team,
including their ages, as of December 31, 2025:
Name | Age | Position | Nationality | Date of Initial Appointment | ||||
Tim Van Hauwermeiren1) | 53 | CEO and Executive Director | Belgium | July 15, 2008 | ||||
Karen Massey2) | 47 | COO | Australia | March 13, 2023 | ||||
Karl Gubitz | 56 | CFO | South Africa and U.S. | June 1, 2021 | ||||
Peter Ulrichts | 46 | Chief Scientific Officer | Belgium | January 1, 2023 | ||||
Malini Moorthy | 56 | General Counsel and Corporate Secretary | Canada and U.S. | February 14, 2022 | ||||
Luc Truyen | 61 | Chief Medical Officer | Belgium and U.S. | April 1, 2022 | ||||
Arjen Lemmen | 41 | Vice-President Corporate Development & Strategy | The Netherlands | May 1, 2016 | ||||
Andria Wilk | 53 | Global Head of Quality | UK | January 13, 2020 |
1)Tim Van Hauwermeiren will transition from his current CEO role to the position of Non-Executive chairperson of the Board of Directors after
receiving approval from the shareholders during the 2026 General Meeting.
2)It is envisaged that Karen Massey, our current COO, will be appointed as an Executive Director at the 2026 General Meeting and subsequently
elected as CEO by the Board of Directors.
Tim Van Hauwermeiren
Tim Van Hauwermeiren co-founded our Company in 2008 and has served as our CEO since July 2008. He has served as
a member of our Board of Directors since July 2014.
Tim Van Hauwermeiren has almost 31 years of general management and business development experience across the
life sciences and consumer goods sectors. He also serves on the board of directors of Lexeo Therapeutics, Inc. and
Denali Therapeutics, Inc.
Karen Massey
Karen Massey has served as our COO since March 2023.
Ms. Massey has over 25 years of experience in the pharmaceutical and biotechnology industry, including in commercial,
product development, corporate strategy, and innovation roles. Prior to joining argenx, Ms. Massey was with Genentech
(Roche Group) for over nine years, where she most recently served as senior vice president of product development and
global clinical operations and previously held various commercial leadership roles across marketing and business
operations, including as the vice president of the multiple sclerosis and neuromyelitis optica business. Ms. Massey
started her biopharmaceutical career in marketing at Pfizer Inc., and returned there, after two years as a management
consultant at Bain & Company, to take on leadership positions in corporate strategy and sales and as a commercial lead
in Latin America.
Karl Gubitz
Karl Gubitz has served as our CFO since June 2021.
Mr. Gubitz previously worked at Pfizer Inc. for nearly 20 years, most recently as vice president of finance within the
global oncology business. Within Pfizer Inc., Mr. Gubitz held country, regional, and global positions, and consistently
delivered top-line growth. He managed teams of over 250 colleagues in financial leadership roles within the global
internal medicine and global innovative products businesses. Prior to joining Pfizer Inc. in 2003, Mr. Gubitz held various
management roles at PricewaterhouseCoopers LLP.
Peter Ulrichts
Peter Ulrichts has served as our chief scientific officer since January 2023. In this role, he oversees the development of
all clinical and pre-clinical compounds within our pipeline.
79 | ||
Dr. Ulrichts previously served in various roles at the Company since he joined us in 2010, including, most recently, as
our head of clinical science. As a research scientist, Dr. Ulrichts was involved in the development of various therapeutic
antibodies for the treatment of cancer and autoimmune diseases. In 2013, he headed the development of our FcRn
antagonist efgartigimod until the first-in-human clinical trial. He subsequently transitioned to become the lead scientist
of our efgartigimod program.
Malini Moorthy
Malini Moorthy has served as our general counsel and corporate secretary since February 2022.
She has over 26 years of extensive global legal and compliance experience in the biopharmaceutical and medical device
industries. She was most recently senior vice president and chief deputy general counsel of legal, compliance, and
government affairs at Medtronic plc, where she played a pivotal role in shaping and driving enterprise and functional
strategies. Before joining Medtronic plc, Ms. Moorthy spent four years at Bayer Corporation as the head of global
litigation and investigations and 10 years at Pfizer Inc., where she progressed to lead civil litigation globally. Ms.
Moorthy began her career as a law firm associate, first with McCarthy Tétrault LLP and Genest Murray Desbrisay
Lamek LLP in Toronto, Canada and then Salans LLP (now Dentons US LLP) in New York City.
Luc Truyen
Luc Truyen has served as our chief medical officer since April 2022 and previously served as our head of research and
development operations management from September 2021 to April 2022.
Prior to this, Dr. Truyen was with Johnson & Johnson (and its subsidiary companies) for over 21 years holding various
leadership positions, primarily within neuroscience. In his most recent position prior to joining argenx, Dr. Truyen was
global head of development and external affairs for neuroscience, managing the strategy and delivery of the early and
late portfolio of assets for mood disorders, schizophrenia, and neurodegenerative and neuroinflammatory disorders.
Besides Dr. Truyen’s strong track record in clinical development resulting in several globally innovative drug approvals,
his broad-based experience also includes leading global clinical development operations for the whole Johnson &
Johnson pharmaceutical group as well as serving as the head of research and development and chief medical officer of
Janssen Alzheimer Immunotherapy Research & Development LLC, an internal spin-out from Johnson & Johnson.
Arjen Lemmen
Arjen Lemmen joined argenx in 2016 and has served as our vice president of corporate development & strategy since
2019. He has successfully executed several transactions including a number of programs within the IIP.
Prior to joining the Company, Mr. Lemmen served as a corporate finance specialist at Kempen & Co NV focusing on
mergers and acquisitions, equity capital markets and strategic advisory transactions in the European life sciences
industry.
Andria Wilk
Andria Wilk joined argenx as global head of quality in January 2020. Ms. Wilk has more than 26 years of experience in
quality assurance within the pharmaceutical industry. Most recently, Ms. Wilk served as senior director, head of medical,
regulatory & clinical quality assurance at H Lundbeck A/S, where she managed the global medical, regulatory & clinical
quality assurance group based in the EU, U.S., and Asia. In this role, she was responsible for the global audit programs
and quality assurance support for all clinical trial and post-marketing activities and related computerized systems.
Prior to H Lundbeck A/S, she held various quality assurance positions of increasing responsibility within AstraZeneca
plc, Takeda Global Research, Development Centre Europe, and Astellas Pharma Inc.
General Information About Our Directors and Senior Management
As of the date of this Annual Report (or in any period before), none of the members of our Board of Directors and senior
management has or has had a family relationship with any other member of our Board of Directors or senior
management, and there are no arrangements or understandings with major shareholders, customers, suppliers or others,
pursuant to which any person referred to above was selected as a member of our Board of Directors or senior
management. For further information regarding any arrangements pursuant to which our Board of Directors or senior
management were appointed, see “Item 7.B. — Related Party Transactions — Agreements with Our Senior
Management”.
80
B.COMPENSATION
Remuneration Report and Compensation Statement
Letter from the Chairperson of the Remuneration and Nomination Committee
Dear Stakeholders,
Introduction
On behalf of the Remuneration and Nomination Committee, I am pleased to present the 2025 remuneration report (the
2025 Remuneration Report), which outlines the Committee’s activities over the past year and provides insight into how
the Company’s achievements and continued progress in 2025 have shaped the remuneration of our CEO and Board of
Directors.
In compliance with article 2:135b of the Dutch Civil Code, the European Shareholder Rights Directive and the DCGC,
this 2025 Remuneration Report discloses how we implemented our 2021 Remuneration Policy for the Board of Directors
and CEO in 2025 and explains how we will move forward with the 2025 Remuneration Policy, which became effective
upon receiving shareholder approval at the 2025 Extraordinary General Meeting, held on November 18, 2025. In so
doing so we hope that we can demonstrate the CEO is not only rewarded for immediate achievements, but also for
sustained progress in our business strategies, individual objectives, and key strategic non-financial metrics that we
believe underpin our long-term mission and strategy.
argenx performance in 2025
2025 was a year of strong execution and strategic delivery across argenx’ core priorities. We made substantial progress
toward our Vision 2030 ambition of reaching 50,000 patients globally, treating approximately 19,000 patients across
three indications (gMG, CIDP and ITP) and three product presentations. We successfully launched the VYVGART
Hytrulo pre‑filled syringe in MG and CIDP, which expanded access to new patient segments and enabled more
convenient treatment options. At the same time, the Company continued to invest in long‑term value creation by
advancing a robust and diversified pipeline, entering 2026 with 10 ongoing registrational clinical trials and adding four
new molecules to the pipeline. Our Senior Management Team, including the CEO, CFO and COO (Named Executive
Officers or NEOs), guided the organization through a year of operational intensity, progressing late‑stage clinical
programs, supporting regulatory submissions, scaling commercial operations and building the infrastructure required for
sustainable growth, while positioning argenx for its next phase of leadership and innovation.
In gMG, we strengthened our position as the #1 prescribed and fastest‑growing biologic, supported by increasingly
earlier use in the treatment paradigm and continued expansion into broader patient populations. Positive topline data
from the Seronegative gMG clinical trial strengthened our ambition to be the treatment of choice and to pursue the
broadest MG label to date. In CIDP, real‑world outcomes continued to validate the ADHERE results, with physicians
reporting sustained functional improvement and patients experiencing greater independence and quality of life. This
strong commercial execution resulted in a historic milestone for the company, with VYVGART surpassing $1 billion in
product net sales in a single quarter for the first time in the third quarter.
Fixed base pay
After our annual comprehensive base pay review, in 2025 the CEO, CFO and COO’s base pay increased from EUR
700,000 to EUR 732,000 ($827,160), $553,000 to $578,000 and CHF 594,000 to CHF 615,000 ($741,641), which is an
increase of 4.6%, 4.5% and 3.5% respectively. These increases are determined in accordance with the Company’s global
base pay increase principles and guidelines and are consistent with the methodology used to determine base pay
increases for employees across the organization. In addition, they reinforce our commitment to a balanced, performance-
driven remuneration structure that supports sustainable long-term value creation, while maintaining fairness and
transparency and taking into account annually performed scenario analyses, including benchmarking exercises in setting
total remuneration levels.
Even with the above-referenced increase, the CEO’s base pay, at his own request, remained below the 25th percentile of
the 2024 peer group.
Short Term Performance Pay
The CEO, CFO and COO delivered strong performance outcomes in 2025, resulting in STI payouts of 150% of target for
the CEO, 150% for the CFO and 175% for the COO. These outcomes reflect the successful launch of the pre-filled
syringe on April 10, 2025, associated revenue growth and continued delivery against key strategic priorities. The
81 | ||
Remuneration and Nomination Committee considers that these results accurately reflect performance against the targets
set at the start of the year and demonstrate clear alignment between pay and performance. Further details on individual
achievements are provided in the main body of the report.
Long Term Performance Pay
Over 2025, argenx’s share price rose by 20% from €600.00 to €716.80. In fact, over a three-year period, from December
31, 2022 to December 31, 2025, the share price has risen by approximately 106%, from €348.30 to €716.80 per share,
further underscoring the NEOs successful long-term performance.
Under the 2021 Remuneration Policy, as part of the long-term incentive pay (LTIP), the NEOs received RSUs and stock
option grants. For disclosure on these awards vesting in 2025, please refer to ‘‘Section 3.4.3 LTIP’’ of this 2025
Remuneration Report.
Under the 2025 Remuneration Policy approved in November 2025, RSUs have been replaced by PSUs. As a result, the
LTIP is now fully ‘at-risk’ as it is entirely performance-based and a mixture of stock options (no more than 50% of the
annual grant) and PSUs (at least 50% of the annual grant). For the PSU portion of the 2025 grant, they will be assessed
on the following performance metrics and targets:
•Maximize the VYVGART opportunity consisting of the following targets: 2027 annual revenue (50%) and gMG
Label Expansion (15%);
•Build a portfolio of breakthrough antibody-based products consisting of the following target: FDA submissions
(15%);
•Ensure long-term sustainability as an independent company consisting of the following target: Pipeline progression
(10%); and
•Scaling the argenx way consisting of the following target: talent retention (10%).
For further information on the 2026 PSU awards, please refer to ‘‘Item 6.B — Remuneration Report and Compensation
Statement — LTIP’’ of this 2025 Remuneration Report.
Stakeholder Engagement
Shareholders play a crucial role in our success by providing invaluable support and fostering strong partnerships that are
essential to our growth. We deeply appreciate their continued commitment and strive to keep them well-informed,
ensuring a lasting and productive relationship.
During 2025, we directly engaged with our top 60 shareholders and other shareholders who previously engaged with us
(holding a total of approximately 70% of our shares) as well as with proxy advisors, resulting in strong shareholder
endorsement, with approximately 96% of votes cast in favor of the 2025 Remuneration Policy during the 2025
Extraordinary General Meeting held on November 18, 2025, reflecting broad support for the Company’s approach to
executive remuneration.
Looking Forward
As announced on January 5, 2026, our current CEO, Tim Van Hauwermeiren, will transition from his CEO role to the
position of Non-Executive chairperson of the Board of Directors, subject to receiving approval from the shareholders
during the 2026 General Meeting. I would like to express the Committee’s immense appreciation for his great leadership,
contributions and accomplishments delivered since the Company’s founding in 2008. The Board of Directors will
appoint our current COO, Karen Massey, as our new CEO, following the approval of her nomination to Executive
Director by the shareholders during the 2026 General Meeting. We are delighted to receive overwhelmingly positive
feedback from shareholders since the announcement of the leadership transition and strong support for both Tim Van
Hauwermeiren and Karen Massey’s new roles.
Tim Van Hauwermeiren’s anticipated CEO remuneration for 2026 will be in accordance with the provisions of the 2025
Remuneration Policy and is summarized below:
•Treatment of base pay: The annual base pay for 2026 will be paid, pro-rated, up to and including the date of his
resignation as CEO at the 2026 General Meeting.
82 | ||
•Treatment of 2026 STI: The 2026 STI will be paid on a pro-rated basis up to and including the date of his resignation
as CEO at the 2026 General Meeting, in accordance with the Founder CEO legacy agreement. Full details will be
disclosed in the 2026 Remuneration Report.
•Treatment of LTI: All unvested equity other than PSUs will immediately and fully vest at the time of the 2026
General Meeting. The PSUs granted in 2025 will remain subject to their normal three-year performance period and
will vest in 2027, based on performance and pro-rated for time served as CEO in calendar years 2025 and 2026 (up to
and including the date of his resignation as CEO at the 2026 General Meeting). Tim Van Hauwermeiren will not
receive a new pro-rated 2026 LTIP grant, including both stock options and PSUs.
Subject to approval by the shareholders at the 2026 General Meeting, Tim Van Hauwermeiren’s remuneration
arrangements as Non-Executive chairperson of the Board of Directors will be in accordance with the 2025 Remuneration
Policy.
For more information regarding Tim Van Hauwermeiren’s 2026 compensation as CEO and as Non-Executive
chairperson of the Board of Directors, including when details on achievement and pay-out will be available, please refer
to section ‘‘Item 6.B — Remuneration Report and Compensation Statement — Looking Forward’’ below.
More information on Karen Massey’s remuneration will be disclosed in the convocation notice for the 2026 General
Meeting, which will become available on or around the date of this 2025 Remuneration Report.
I share the enthusiasm and excitement expressed by our shareholders about the upcoming leadership transition, and I am
confident that with Tim Van Hauwermeiren as the Non-Executive chairperson of the Board of Directors and Karen
Massey as CEO, argenx is extremely well-positioned for the long term.
We will continue to engage actively on this leadership transition and other relevant topics with our key stakeholders and
proxy advisors throughout 2026 and beyond. We remain available to address any questions regarding corporate
governance and executive compensation.
On behalf of the Remuneration and Nomination Committee I would like to thank all our investors, employees and
stakeholders for their continued support and I ask that shareholders vote to approve this report at the 2026 General
Meeting.
Ana Céspedes
Chairperson, Remuneration and Nomination Committee
Remuneration Policy
Summaries for each approved policy, which guided our backward-looking and forward-looking pay decisions during the
year-under-review are below. For more details on these policies, please refer to the below links provided
•The 2021 Remuneration Policy: https://argenx.com/content/dam/argenx-corp/media-documents/
argenx_remuneration_policy_final_approved_11_May_2021.pdf.
•The 2025 Remuneration Policy: https://argenx.com/content/dam/argenx-corp/media-documents/
EGM_November_2025-Remuneration_Policy.pdf.
83 | ||
Executive Director Remuneration Policy
Pay Element | 2021 Remuneration Policy (77% approval) | 2025 Remuneration Policy (approx. 96% approval) | ||
Base Pay | •Set at or around the 50th percentile of U.S. peer group for U.S.-based executives, and around the 75th percentile of EU peer group for EU-based executives. | •Targets the 50th percentile of the Executives in the peer group. | ||
Benefits and Pension | •Customary fringe benefits including pension contributions, hospitalization and disability insurance, severance arrangement, company car, phone, and laptop. | •Benefits and pension contributions aligned with those of other employees within the same legal entity and in accordance with local market practice. | ||
Short-Term Incentive | •Cash-based target STI for CEO is 60% of base pay at 100% target achievement; maximum payout of 120% of base pay. •Typically 60% of targets related to quantitative targets (building the business) and 40% of targets related to qualitative targets (building the organization). Target mix was not fixed. | •Quantum unchanged from 2021 Remuneration Policy. •Majority of targets are quantitative and at least 50% of STI linked to financial performance targets. Qualitative targets will be milestone-based to the extent possible. | ||
Long-Term Incentive | •100% time-based LTI (no performance conditions). Plan consisting of time-based stock options and time-based RSUs. •No cap on LTI opportunities included. •Stock options vest 1/3 after 1 year and then in monthly installments until the end of the 3-year period. RSUs vest 25% on each anniversary of the grant date. | •100% risk-based; LTI with no less than 50% PSUs and no more than 50% stock options. •The annual LTIP opportunity is 7x base pay at target / 10x at maximum. •As of 2026, stock options and PSUs have a 3-year cliff vesting period; no equity vests before the end of the 3 years. | ||
Shareholding Requirements | •No shareholding requirements. | •Equal to 6x annual base pay in the form of company equity (excluding non-vested RSUs/ PSUs and stock options), to be built up over a maximum of five years. | ||
Clawback provisions | •No clawback policy | •Clawback policy in place applicable to variable remuneration paid out on the basis of financial information which is subsequently restated. | ||
Recruitment Provisions | •Board may grant additional 1x regular equity grant as sign-on award. | •May offer buyout awards to compensate for value lost by changing employers. |
84 | ||
Pay Element | 2021 Remuneration Policy (77% approval) | 2025 Remuneration Policy (approx. 96% approval) | ||
Leaver Provisions | •No explicit leaver provisions. | •STIP: Legacy provision for current Executive Director to be pro-rated for time and performance upon termination. For any other Executive Director, there will be no STI payout unless in service on 31 December of that performance year. •LTIP: Legacy provision for current Executive Director provides for immediate and full vesting at time of termination, except for the PSUs. For any other Executive Director, upon leaving the Company, unvested stock options and PSUs are forfeited without compensation. During performance period other than dismissal for cause or underperformance, vesting of PSUs will be pro- rated for time and performance at the end of 3- year performance period. | ||
Peer Group | •Reference group includes European and U.S.- based integrated, commercial-stage life science companies. Selected for comparability in size, activities and market presence | •Reference group comprises European and U.S.- based commercial-stage biopharmaceutical companies selected for comparability in innovation focus, global reach, size (revenue and market value relative to argenx), market presence and public listing. |
Non-Executive Director Remuneration Policy
Pay Element | 2021 Policy (77% approval) | 2025 Policy (96% approval) | ||
Cash | •Benchmarked regularly fees could be adjusted as necessary based on regular benchmarking exercises to ensure continued fair and competitive remuneration. | •Annual cash retainer fee targets the 50th percentile of the peer group and benchmarked annually. 2025 Board of Directors membership fee: $60k per year, with additional $59.5k for the chairperson. Committee members receive (depending on the committee) $10,000-12,500 for membership or $20,000-25,000 for chairmanship. | ||
Equity | •Share options and/or restricted share units in an amount that is at or around the 50th percentile of the U.S. companies in our reference group. Per 2021, we granted 2,700 stock options and 600 RSUs to each Non-Executive Director. Equity granted was adjusted on the basis of benchmark outcomes and in consideration of developments in the composition of equity incentives offered by argenx to key persons outside the Board of Directors, including company employees. •RSUs vest over 4 years and stock options vesting over 3 years. •Since 2024, stock options no longer granted to Non-Executive Directors to avoid any perceived effect on independence; switched to granting RSUs. | •Annual equity grant of $400,000 in the form of restricted shares with no vesting conditions, targeting the 50th percentile of the peer group and subject to annual review. No shares may be sold until after the 4th anniversary of the grant date, except to the extent necessary to cover immediate tax obligations resulting from the vest. •Restricted shares are not subject to vesting conditions. 4-year holding requirement for equity grants (except sales to cover immediate tax obligations). |
85 | ||
Pay Element | 2021 Policy (77% approval) | 2025 Policy (96% approval) | ||
Shareholding Requirements | •No shareholding requirements. | •Holding of 5x annual Board of Director membership retainer fees (as at the date of the 2025 Remuneration Policy, the annual retainer fee was $60,000), to be built over a period of 5 years. | ||
Special travel allowance | •No special travel allowance. | •Special travel allowance of $5,000 for in-person attendance at each board meeting held outside of a Non-Executive Director’s official continent of residence. |
Reference Peer Group
Selection Criteria
The argenx peer group is based on the following selection criteria:
•Sector (Biopharmaceutical companies, excluding diagnostics and animal health companies);
•Innovation focus (at least 25% of revenue is spent on R&D);
•Global reach (generates product revenues both within and outside the US);
•Revenue (1/4x – 4x of our annual revenue);
•Market capitalization (1/4x – 4x of our 30-day average market cap on the last business day prior to the date of the
Company-wide grant in June); and
•Listing location (listed on a major US Stock Exchange).
If there are fewer than 15 companies meeting all six criteria, the peer list will be supplemented with companies that meet
all but one criterion with the least relevant criterion dropped first, in the order as displayed above (from most to least
relevant).
For the 2025 Peer Group that was selected in Q3 2025, we made adjustments to our benchmarking methodology. In
response to shareholder feedback, we shifted the US listing criterion from the second most important criterion to the
criterion with the least significance. This resulted in an increase from 26.67% European peers in the 2025 Peer Group to
40% European peers in the 2025 Peer Group.
The 2025 Peer Group was composed of the following global reference companies
•US Companies: Alnylam Pharmaceuticals, Biogen, BioMarin Pharmaceutical, Incyte, Insmed, Moderna, Regeneron
Pharmaceuticals, Sarepta Therapeutics, Vertex Pharmaceuticals.
•European Companies: Ascendis Pharma, BeOne Medicines, BioNTech, Genmab, Jazz Pharmaceuticals, UCB.
Each year, the Remuneration and Nomination Committee will validate the peer group to ensure its relevance and the
Remuneration and Nomination Committee may recommend adjustments to the Board of Directors, if deemed necessary.
NEO Remuneration in FY25
Base pay
After our annual comprehensive base pay review, the CEO, CFO and COO’s base pay increased from EUR 700,000 to
EUR 732,000 ($827,160), $553,000 to $578,000 and CHF 594,000 to CHF 615,000 ($741,641), which is an increase of
4.6%, 4.5% and 3.5% respectively. These increases are determined in accordance with the Company’s global base pay
increase principles and guidelines and are consistent with the methodology and base pay increases for employees across
the organization. In addition, they reinforce our commitment to a balanced, performance-driven remuneration structure
that supports sustainable long-term value creation, while maintaining fairness and transparency and taking into account
annually performed scenario analyses including benchmarking exercises in setting total remuneration levels.
86 | ||
Pension and fringe benefits
The benefits paid to the NEOs are jurisdiction dependent. For the CEO, these included benefits customary in the Belgian
market, and which are standard components of Belgian-based employee packages: pension contributions, a
hospitalization insurance, a representation allowance and a company car. The Company pension contribution percentage
of base pay for the CEO is equal to the Company pension contribution percentage for all employees in Belgium. For the
COO, these included benefits customary in the Swiss market, and which are standard components of Switzerland-based
employee packages: car allowance, lunch allowance, health insurance allowance, representation allowance and pension
contributions. For the CFO, these included benefits customary in the U.S. market, and which are standard components of
our U.S.-based employee packages: a company-administered health benefit plan and 401k plan.
Short Term Incentive Pay
The CEO, CFO and COO participated in the 2025 STIP with target opportunities of 60%, 40% and 50% of base pay, and
maximum opportunities of 120%, 80% and 100% of base pay, respectively. In assessing performance against the
Company’s 2025 business plan, the Board determined that the NEOs delivered a strong year of execution, resulting in
STIP outcomes of 150% of target for the CEO and CFO and 175% for the COO.
Specifically for the CEO, he delivered strong performance against the measures. He exceeded the annual operating
budget revenue targets, successfully executing the PFS launch in the U.S., resulting in achieving the maximum
opportunity for the revenue goal. Target achievement was reached for the pipeline goal as the MG combination clinical
trial was launched and 3 new candidates were nominated and 3 new molecules graduated. The Innovation goal was also
met at target through championing key innovation projects and embedding innovation goals into the performance targets
of employees. Lastly, succession plans for key senior leaders as well as the CEO succession were accomplished at target
for scaling the argenx way goal to secure long-term leadership strength & organizational capabilities. The overall strong
performance resulted in a total weighted achievement of 150% of target opportunity.
Specifically for the CFO, he delivered a strong performance against the measures. He also exceeded the annual operating
budget revenue targets, successfully executing the PFS launch in the US, resulting in achieving the maximum
opportunity for the revenue goal. Maximum opportunity was also achieved for making substantial progress on the digital
finance transformation goal, including reductions in financial closing timelines, automation of financial processes and
transforming the planning cycle. Target achievement was reached for the P&L goal by effectively managing the
Company’s tax commitments and managing headcount growth within the approved budget parameters, supporting
disciplined scaling for scaling the argenx way goal. The overall strong performance resulted in a total weighted
achievement of 150% of target opportunity.
Specifically for the COO, she delivered a very strong performance against the measures. Just like the CEO and CFO, she
exceeded the annual operating budget revenue targets, successfully executing the PFS launch in the US, resulting in
achieving the maximum opportunity for both the revenue and pipeline acceleration goals. Maximum opportunity was
also achieved for operational and digital transformation priorities, including the successful onboarding of the BIS leaders
and execution of key transformation objectives. Lastly, critical leadership hires were successfully onboarded and
operational excellence initiatives were embedded to accelerate novel therapies to patients, resulting in target achievement
for scaling the argenx way goal. The overall very strong performance resulted in a total weighted achievement of 175%
of target opportunity.
The Board considers the selected performance metrics to remain the most appropriate measures of NEO performance, as
they reflect the Company’s key strategic, operational and financial priorities. The tables below outline the targets set and
the corresponding achievements for each NEO.
87 | ||
CEO 2025 STIP
Performance Metric and Weighting | Measurement (how the Board of Directors evaluated the target) | Threshold | Target | Max | Achievement | Vesting | Actual pay-out | |||||||
Revenue (50%) | •Annual operating budget revenue target delivered •Successful PFS self- administration approval and launch in the U.S. | 80% of annual operating budget target | 100% annual operating budget | 120% annual operating budget | 120% annual operating budget | 100% | 496,296 | |||||||
Pipeline (20%) | •MG combo clinical trial launched Q3 and/or •Nominate 2 new ARGX-xxx candidates and graduate 3 discovery projects to lead identification (PPD) | •Combo trial launched •1 new ARGX- xxx candidate nominated •2 molecules graduated | •Combo trial launched •2 new ARGX-xxx candidate nominated •3 molecules graduated | •Combo trial launched in Q3 •3 new ARGX- xxx candidate nominated •4 molecules graduated | •Combo trial launched •2 new ARGX-xxx candidate nominated •3 molecules graduated | 20% | 99,259 | |||||||
Innovation (20%) | •Champion key innovation projects AND •All variable pay eligible employees have 1x performance goal linked to innovation AND •Key innovations recognized, celebrated and cascaded throughout the Company | •1x innovation projects championed AND •80% of employees 1x performance goal linked to innovation AND •3x key innovation celebrated at the Corporate update | •3x innovation projects championed AND •90% of employees 1x performance goal linked to innovation AND •3x key innovation celebrated at the Corporate update | •5x innovation projects championed AND •100% of employees 1x performance goal linked to innovation AND •3x key innovation celebrated at the Corporate update | •3x innovation projects championed AND •90% of employees 1x performance goal linked to innovation AND •3x key innovation celebrated at the Corporate update | 20% | 99,259 | |||||||
Scaling the argenx way (10%) | •Succession plan in place for key senior leaders | No plan in place | Plan in place | N/A | Plan in place | 10% | 49,630 |
88 | ||
CFO 2025 STIP
Performance Metric and Weighting | Measurement (how the Board of Directors evaluated the target) | Threshold | Target | Max | Achievement | Vesting | Actual pay-out | |||||||
Revenue (30%) | •Annual operating budget revenue target delivered AND •Successful PFS self- administration approval and launch in the U.S. | 80% of annual operating budget | 100% annual operating budget | 120% annual operating budget | 120% annual operating budget | 60% | 138,720 | |||||||
P&L (25%) | •Target effective tax rate in 2025 in line with annual operating budget | Effective tax rate 5% higher than annual operating budget | Effective tax rate in line with annual operating budget | Effective tax rate 5% lower than annual operating budget | Effective tax rate in line with annual operating budget | 25% | 57,800 | |||||||
Digital transformation (25%) | •Time required to close the quarter reduced by 50% AND •Annual operating budget process transformation AND •Financial accounts automation | 2/3 metrics achieved | 3/3 metrics achieved | Significant additional digitalization achieved beyond the 3/3 metric achieved | Significant additional digitalization achieved beyond the 3/3 metric achieved | 45% | 104,040 | |||||||
Scaling the argenx way (20%) | •Management headcount growth | Headcount growth >105% of annual operating budget | Headcount growth < 102% of annual operating budget | N/A | Headcount growth >105% of annual operating budget | 20% | 46,240 |
89 | ||
COO 2025 STIP
Performance Metric and Weighting | Measurement (how the Board of Directors evaluated the target) | Threshold | Target | Max | Achievement | Vesting | Actual pay-out | |||||||
Revenue (40%) | •Annual operating budget revenue target delivered •Successful PFS self- administration approval and launch in the U.S. | 80% of annual operating budget | 100% annual operating budget | 120% annual operating budget | 120% annual operating budget target | 80% | 296,656 | |||||||
Pipeline Acceleration (20%) | •PFS FDA approval | FDA acceptance | •FDA acceptance with no concerns and review on track | •FDA acceptance with PDUFA date < 6 months | •FDA acceptance with PDUFA date < 6 months | 40% | 148,328 | |||||||
Digital transformation (20%) | •Successful onboarding of Business Information Systems (BIS) leader and deliver on the BIS OGSM | 50% of the BIS OGSM measures delivered | Onboarded and delivered per annual operating budget AND 80% of the BIS OGSM measures delivered | Onboarded and delivered per annual operating budget AND 90% of the BIS OGSM measures delivered | •Onboarded and delivered per annual operating budget AND •90% of the BIS OGSM measures delivered | 35% | 129,787 | |||||||
Scaling the argenx way (20%) | •Successful onboarding of key hires and leadership teams' their OGSMs AND •Elevate the operational excellence community to a leadership community and their OGSM delivered | N/A | Accomplished | N/A | Accomplished | 20% | 74,164 |
90 | ||
2026 STIP
The majority of the targets will be quantitative in nature and at least 50% of the total STIP opportunity for the NEO will
be linked to financial performance metrics. Qualitative targets will be milestone-based to the extent possible. For the
2026 STIP, the targets chosen are:
CEO: Performance Metric, Target Area and Weighting | Measurement (how the Board of Directors evaluate the target) | |
Deliver continued VYVGART growth (50%) | 2026 financial plan revenue target delivered | |
Pipeline Acceleration (25%) | •Deliver Ocular MG, Myositis and MMN top line data read- outs in 2026 (10%) •On track to deliver SjD & CIDP data read-outs in 2027 (5%) •Not disclosed (10%) | |
Successful CEO transition (25%) | •Retention of key talent (12.5%) •Shareholder feedback on transition (12.5%) |
The STIP for the current CEO Tim Van Hauwermeiren will be pro-rated for time and performance until his resignation
as CEO at the 2026 General Meeting.
CFO: Performance Metric, Target Area and Weighting | Measurement (how the Board of Directors evaluate the target) | |
Deliver continued VYVGART growth (50%) | 2026 financial plan revenue target delivered | |
Capital allocation for long-term sustainable growth (25%) | Not disclosed | |
Champion digitization, automation, simplification and AI (10%) | Simplify and digitize financial processes | |
Scaling the argenx way (15%) | Headcount growth (15%) |
COO: Performance Metric, Target Area and Weighting | Measurement (how the Board of Directors evaluate the target) | |
Deliver continued VYVGART growth (50%) | 2026 financial plan revenue target delivered | |
Pipeline Acceleration (25%) | •Deliver Ocular MG, Myositis and MMN top line data read- outs in 2026 (10%) •On track to deliver SjD & CIDP data read-outs in 2027 (5%) •Not disclosed (10%) | |
Scaling the argenx way (15%) | Headcount growth (15%) | |
Successful CEO transition (10%) | •Retention of key talent (5%) •Shareholder feedback on transition (5%) |
The Company will disclose the actual targets set on a threshold, target and maximum basis and achievements in the 2026
remuneration report, in line with the disclosure on the 2025 STIP achievements.
LTIP
1.Awards Vesting in 2025:
Under the 2021 Remuneration Policy as part of the long-term variable pay the CEO received RSUs and stock option
grants. As these had various vesting schedules, please refer to the tables included in ‘‘Item 6.B — Remuneration Report
and Compensation Statement — Stock Option Overview’’ below for the disclosure on the value of these awards vesting
in 2025.
91 | ||
2.Awards Granted in 2025:
As per our 2025 Remuneration Policy, non-performance equity (RSUs) has been phased out of the LTIP. The following
information sets out the number, value and key terms of LTIP awards granted to the CEO in 2025. Notably, both stock
options and PSUs are based on three-year vesting schedules as included in our 2025 Remuneration Policy.
•Stock Options: The number of stock options was calculated by dividing the target value through the then applicable
Black-Scholes value based on 30 calendar days preceding the 15th day of the month in which the grant occurs (the
Reference Date), rounded up to the nearest whole number. The stock options granted on June 30, 2025 to the CEO
have an exercise price of €479.30 / $561.74.
•PSUs: The numbers of PSUs was calculated by dividing the target value through the average closing price 30
calendar days preceding the Reference Date, rounded up to the nearest whole number.
•Target Value: Using the above methodology, the total LTIP target grant was valued at $5,790,000, $3,395,000, and
$3,895,000 which is 7.0, 5.9 and 5.3 times the CEO’s, CFO’s and COO’s base salaries, respectively. The CEO and
CFO received their respective equity grants converted into a number of stock options and PSUs on the Reference
Date of the 30-days average share price of 510.88 EUR/$569.17 per share preceding the Reference Date and the
Black-Scholes model fair market value of 172.92 EUR/$192.65 per stock option. Consequently, 15,027, 8,812,
10,110 stock options (50% of the LTIP grant) and 5,085, 2,983, 3,423 PSUs (50% of the LTIP grant) were granted to
the CEO, CFO and COO, respectively.
•NB: Relevant for CEO only as he is a Belgian beneficiary: these amounts do not reflect the actual economic value
realized by the beneficiary. Amounts included represent the expenses with respect to the assumptions used in the
Black-Scholes model which differ between Belgian beneficiaries versus non-Belgian beneficiaries, resulting in the
CEO’s stock based compensation expenses being higher than other beneficiaries. For a description of the assumptions
used, refer to “Note 13 — Share-Based Payments in the ‘‘Consolidated Financial Statements” which are included to
our Annual Report for the period ended December 31, 2025.
PSUs
Together with the rest of the Senior Management Team, the CFO and the COO Karen Massey, who is envisaged to be
elected as an Executive Director during the 2026 General Meeting and subsequently transition into the role of CEO, are
eligible to receive a PSU grant in 2026.
The current CEO, Tim van Hauwermeiren, will not receive a pro-rated PSU grant for 2026 in connection with his
transition into the role of Non-Executive Director and Chairperson of the Board of Directors at the 2026 General
Meeting.
The four measures of the 2026–2028 PSUs are based on the following principles:
•at least 50% of the pay opportunity will be linked to financial performance metrics such as revenue growth;
•at least 40% of the pay opportunity will be linked to innovation and pipeline progression metrics, such as delivering
clinical and regulatory milestones; and
•up to 10% of the pay opportunity will be linked to people and culture metrics essential for sustainable, long-term
value creation.
92 | ||
Performance Metric | Target | Measurement (how the Board of Directors will evaluate the metric and why it has been chosen) | Threshold | Target | Max | |||||
Maximize the VYVGART opportunity (50%) | 2028 annual revenue | Minimum product net sales of undisclosed amount | Targets and Executive Director achievement will be disclosed retroactively in the 2028 remuneration report, published in 2029 | |||||||
Pipeline progression (40%) | (s)BLA Approvals (in addition to potential Seronegative gMG and Ocular MG) (20%) | Undisclosed number of new approvals | ||||||||
Phase (ii) Progression and/or IND / CTA Assets Submissions (20%) | Undisclosed number of new pipeline assets into phase 2 and/or undisclosed number of new additional pipeline assets IND / clinical trial application submitted | |||||||||
Scaling the argenx way (10%) | Talent retention | Three-year average voluntary employee turnover equal to or below 6.5% (target) or equal to or below 8.5% (floor) | ||||||||
Shareholding Requirements
The remuneration policy requires an Executive Director to build up a shareholding requirement 6x their base pay. On
December 31, 2025, the CEO is in compliance with this requirement.
Clawback policy
In the year ended December 31, 2025, no variable remuneration was clawed back and no variable remuneration was
adjusted (retroactively).
Looking Forward – Mr Van Hauwermeiren
2026 CEO position
As Tim Van Hauwermeiren will be treated as a good leaver, his anticipated CEO remuneration for 2026 will be
delivered in accordance with the provisions of the 2025 Remuneration Policy and is outlined below:
•Treatment of base pay: The annual base pay for 2026 will be paid, pro-rated, up to and including the date of his
resignation as CEO at the 2026 General Meeting. This is expected to amount to EUR 261,665, being a 126 day pro-
rated pay out of the full 2026 base pay of EUR 758,000.
•Treatment of 2026 STI: The 2026 STI will be paid on a pro-rated basis up to and including the date of his resignation
as CEO at the 2026 General Meeting. Achievement and pay-out will be determined on the date of resignation at the
2026 General Meeting and will occur shortly thereafter to facilitate his full transition into a Non-Executive Director
and chairperson of the Board of Directors. Since at the date of this 2025 Remuneration Report the performance period
is still running until May 6, 2026, disclosure will be included in the 2026 remuneration report, available in the 2027
annual report.
•Treatment of 2025 LTI: All unvested equity other than PSUs will immediately and fully vest at the time of the 2026
General Meeting. The PSUs granted in 2025 will remain subject to their normal three-year performance period and
will vest in 2027, based on performance and pro-rated for time served as CEO in the calendar years 2025 and 2026
93 | ||
(up to and including the date of his resignation as CEO at the 2026 General Meeting). The achievement and pay-out
will be determined based on the information available to us on May 6, 2026 and the actual vesting and pay-out will
occur at the end of the three-year performance period in 2027. Disclosure will be included in the 2027 remuneration
report, available in the 2028 annual report.
•Treatment of 2026 LTI: Tim Van Hauwermeiren will not receive a new pro-rated LTI for 2026, including both stock
options and PSUs. He will therefore not receive any new LTI for the time he serves as CEO in 2026.
After approval by the 2026 General Meeting, Tim Van Hauwermeiren’s remuneration arrangements as Non-Executive
Chair will be in accordance with the 2025 Remuneration Policy.
Non-Executive Director and chairperson of the Board of Directors
After approval of his appointment as Non-Executive Director by shareholders at the 2026 General Meeting, Mr Van
Hauwermeiren’s remuneration arrangements as Non-Executive Director and chairperson of the Board of Directors will,
in accordance with the 2025 Remuneration Policy, be as follows:
•Cash retainer fees: $124,000, consisting of $53,333 for his Non-Executive Director membership of the Board of
Directors, $53,333 for the role of chairperson of the Board of Directors, $8,667 for his Research & Development
Committee membership and $8,667 for his Remuneration and Nomination Committee membership. These fees are
benchmarked at the 50th percentile of cash remuneration in the 2025 Peer Group.
•Annual equity grant: $400,000 in the form of RSUs, which amount is benchmarked at the 50th percentile of the 2025
Peer Group.
Non-Executive Director Remuneration
Total Non-Executive Director remuneration in the year ended December 31, 2025
Name | Cash retainer fees earned or paid in cash (in $)1) | RSU awards (in $) | Total (in $) | |||
Peter Verhaeghe | 142,000 | 394,903 | 536,903 | |||
Steve Krognes | 95,941 | 394,903 | 490,844 | |||
Pamela Klein | 77,500 | 394,903 | 472,403 | |||
Donald deBethizy2) | 37,547 | — | 37,547 | |||
Anthony Rosenberg | 82,500 | 394,903 | 477,403 | |||
James Daly | 97,500 | 394,903 | 492,403 | |||
Camilla Sylvest | 70,000 | 394,903 | 464,903 | |||
Ana Céspedes | 80,941 | 394,903 | 475,844 | |||
Brian Kotzin | 90,000 | 394,903 | 484,903 |
1)This total amount includes the travel allowance of USD 5,000 for in-person attendance of each board meeting held outside the respective Non-
Executive Director’s official continent of residence in accordance with clause 3.5.2 of the 2025 Remuneration Policy.
2)Donald deBethizy retired from the Board of Directors, the Remuneration and Nomination and Research and Development Committee on May 27,
2025.
•The breakdown of the Non-Executive Director cash-fee structure and RSU grants can be found in the tables on the
next page.
•The annual cash retainer fees were at the 50th percentile of cash remuneration in the peer group for 2025
remuneration. Additionally, the Non-Executive Director RSU target amount of $400,000 was at the 50th percentile of
the 2024 peer group for 2025 remuneration.
•There is a difference between the annual equity compensation target amount of $400,000 and the value at grant of
$394,903. On the Reference Date, the annual equity compensation target amount of $400,000 was divided by the
average closing price of the Company’s shares of the 30 calendar days preceding the Reference Date which amounted
to $569.17. The Company’s share price on the grant date of June 30, 2025 was $561.74.
94 | ||
Non-Executive Director Shareholding
Non-Executive Directors are required to hold at least 5x annual Board of Director membership retainer fees ($60,000 in
2025) worth of Company stock for the duration of their role. As of December 31, 2025, all Non-Executive Directors
comply with this requirement.
Deviations
In the year ended December 31, 2025, the Company did not deviate from the decision-making process for Executive and
Non-Executive Director pay and no deviations took place from the 2021 Remuneration Policy or the 2025 Remuneration
Policy.
95 | ||
Annual Cash (top) and Equity (Bottom) Compensation for Non-Executive Directors
In $ | ||||||||||||||||||||||
Relevant body | Position | Fees in $ | Peter Verhaeghe | Steve Krognes | Pamela Klein | Donald deBethizy | Anthony Rosenberg | James Daly | Camilla Sylvest | Ana Céspedes | Brian Kotzin | |||||||||||
Board of Directors | Chairperson | 119,500 | 119,500 | — | — | — | — | — | — | — | — | |||||||||||
Member | 60,000 | — | 60,000 | 60,000 | 24,355 | 60,000 | 60,000 | 60,000 | 60,000 | 60,000 | ||||||||||||
Travel Allowance | 5,000 | — | 5,000 | 5,000 | — | — | 5,000 | — | 5,000 | 5,000 | ||||||||||||
Audit and Compliance Committee | Chairperson | 25,000 | — | 25,000 | — | — | — | — | — | — | — | |||||||||||
Member | 12,500 | 12,500 | — | — | — | 12,500 | 12,500 | — | — | — | ||||||||||||
Remuneration and Nomination Committee | Chairperson | 20,000 | — | — | — | 8,118 | — | — | — | 11,882 | — | |||||||||||
Member | 10,000 | 10,000 | 5,941 | — | — | — | — | — | 4,059 | — | ||||||||||||
Commercial Committee | Chairperson | 20,000 | — | — | — | — | — | 20,000 | — | — | — | |||||||||||
Member | 10,000 | — | — | — | — | 10,000 | — | 10,000 | — | — | ||||||||||||
Research and Development Committee | Chairperson | 20,000 | — | — | — | — | — | — | — | — | 25,000 | |||||||||||
Member | 12,500 | — | — | 12,500 | 5,074 | — | — | — | — | — | ||||||||||||
Total | 142,000 | 95,941 | 77,500 | 37,547 | 82,500 | 97,500 | 70,000 | 80,941 | 90,000 | |||||||||||||
RSUs granted in 20251) | ||||||||||
Name | # RSUs | Key terms | Value at grant 2) | Total | ||||||
Peter Verhaeghe | 703 | (1) | $ | 394,903 | $ | 394,903 | ||||
Ana Céspedes | 703 | (1) | 394,903 | 394,903 | ||||||
James Daly | 703 | (1) | 394,903 | 394,903 | ||||||
Pamela Klein | 703 | (1) | 394,903 | 394,903 | ||||||
Brian Kotzin | 703 | (1) | 394,903 | 394,903 | ||||||
Steve Krognes | 703 | (1) | 394,903 | 394,903 | ||||||
Anthony Rosenberg | 703 | (1) | 394,903 | 394,903 | ||||||
Camilla Sylvest | 703 | (1) | 394,903 | 394,903 | ||||||
1)Donald deBethizy was not granted any RSUs in 2025 because he retired from the Board of Directors on May 27, 2025.
2)There is a difference between the annual equity compensation target amount of $400,000 and the value at grant of $394,903. On the Reference Date, the annual equity compensation target amount of
$400,000 was divided by the average closing price of the Company’s shares of 510.88 EUR/$569.17 in the 30 calendar days preceding the Reference Date. The Company’s share price on the grant date
of June 30, 2025 was $479.30/$561.74.
96 | ||
Pay Ratio
The total expense for the non-equity remuneration paid to the CEO for the year ended December 31, 2025, totalled
$1,631,826. The table below shows the evolution over the past five years of CEO compensation, the performance of the
Company’s stock price and the median remuneration on a full-time equivalent basis (annualized for the employees who
joined or left us during the year) of employees, other than the CEO:
2021 | 2022 | 2023 | 2024 | 2025 | ||||||||
Base pay of the CEO (EUR) | € | 551,250 | 606,368 | 606,368 | 700,000 | 732,000 | ||||||
Base pay of the CEO (USD) | $ | 580,825 | 638,901 | 655,787 | 757,680 | 827,160 | ||||||
Non-equity remuneration of the CEO (USD) (base pay, short-term cash incentive, pension contributions and other compensation elements) | $ | 1,285,136 | 1,443,925 | 1,285,056 | 1,598,471 | 1,631,826 | ||||||
Total remuneration of the CEO (USD) (non-equity remuneration, STI and LTI) | $ | 7,263,828 | 7,778,298 | 11,944,8351) | 7,807,786 | 7,429,771 | ||||||
Non-equity median salary paid to employees (USD) | $ | 157,349 | 153,193 | 159,500 | 180,543 | 195,500 | ||||||
Non-equity remuneration ratio employee/CEO | 12% | 11% | 12% | 11% | 12% | |||||||
Average remuneration paid to Non-Executive Director (USD) | $ | 54,484 | 48,587 | 59,230 | 81,204 | 85,992 | ||||||
Number of employees on December 31 | 650 | 843 | 1,148 | 1,599 | 1,863 | |||||||
Share price at end of year Euronext (EUR) on December 31 | € | 315.30 | 348.30 | 343.50 | 600.00 | 716.80 | ||||||
Share price at end of year Euronext (USD) on December 31 | $ | 357.11 | 371.50 | 379.57 | 623.34 | 842.24 |
1)Based on the approved 2023 equity allocation scheme, the total equity target value for Tim Van Hauwermeirenis equal to $6,986,986. Please
refer to “Item 6.B. — Compensation — Equity — Determination of target value of CEO equity grant included in “Equity ” above for more
information on the variation in granted equity value between 2023 and 2024.
The comparison of non-equity compensation above is made between the compensation paid to the CEO, the Company’s
sole statutory Executive Director on the Board of Directors, and the median compensation paid to employees. The
Company has opted to compare non-equity salaries, because while the number of stock options granted is linked to the
overall size of remuneration packages granted, the value of equity components depends on the evolution of the
Company’s share price, volatility and the risk-free rate, which is unknown at the time of grant and as such the forward-
looking valuation methods for stock options normally do not provide an accurate representation of actual economic value
granted. In the assumptions used, the fair valuation differs between a Belgian beneficiary versus a non-Belgian
beneficiary. For a description of the assumptions used in valuing these awards, please refer to “Note 13 — Share-Based
Payments“ in the "Consolidated Financial Statements” which are included to our Annual Report for the period ended
December 31, 2025.
Regional pay ratios
Due to the global spread of employees over multiple continents, we have also included the above comparison to a
regional basis for U.S. employees, EU employees and Japanese employees. Due to the overall higher compensation level
in the business sector in the U.S. compared to the EU and Japan, there is a significant difference in the pay ratio when
the CEO’s compensation is compared to the median compensation of all employees, compared to employees in the U.S.
The following information is provided for reference purposes:
Ratio of non-equity compensation of the median employee compared to the CEO for the year ended December 31, 2025 | ||
All employees | 12% | |
North American employees | 16% | |
European employees | 9% | |
Japanese employees | 5% | |
Rest of the World employees | 13% | |
Total employment costs (excluding any costs related stock options and RSUs) paid in the year ended December 31, 2025
was split between regions as follows:
97 | ||
Total employment costs in the year ended December 31, 2025 | ||
(in millions of $) | ||
North-America | 272 | |
Europe | 247 | |
Japan | 16 | |
Rest of the World | 3 | |
Share-based payment ratios
2021 | 2022 | 2023 | 2024 | 2025 | ||||||
Stock options granted to the CEO | 25,000 | 25,000 | 30,000 | 18,279 | 15,027 | |||||
RSUs granted to the CEO | 5,700 | 5,700 | 6,700 | 6,762 | 0 | |||||
PSUs granted to the CEO | N/A | N/A | N/A | N/A | 5,085 | |||||
Median stock options granted to employees | 981 | 900 | 600 | 306 | 221 | |||||
Median RSUs granted to employees | 200 | 200 | 94 | 148 | 75 | |||||
Ratio employee/CEO for stock options | 4% | 4% | 2% | 2% | 1% | |||||
Ratio employee/CEO for RSUs1) | 4% | 4% | 1% | 2% | N/A | |||||
Ratio employee RSUs/CEO for PSUs1) | N/A | N/A | N/A | N/A | 1% | |||||
Median number of stock options granted to Non-Executive Directors2) | 2,700 | 2,700 | 1,600 | N/A | N/A | |||||
Median number of RSUs granted to Non-Executive Directors | 600 | 600 | 350 | 1,124 | 703 | |||||
Median stock options granted to employees | 981 | 900 | 600 | 306 | 120 | |||||
Ratio Non-Executive Directors/employee stock options2) | 36% | 33% | 38% | N/A | N/A | |||||
Ratio Non-Executive Directors/employee RSUs | 33% | 33% | 27% | 13% | 11% |
1)In 2025, PSUs were only granted to members of the Executive Management Team and therefore, the median employee has not received PSUs.
2)In 2024 and 2025, the Non-Executive Directors only received RSUs and no longer were granted stock options.
Other Disclosures
Remuneration by subsidiaries
In the year ended December 31, 2025, no remuneration was granted and allocated by subsidiaries or other companies
whose financials are consolidated, other than the regular remuneration payments made by the entities with whom
members of Senior Management Team have their employment contracts.
Severance arrangements
In the year ended December 31, 2025, no severance payments were granted to the Non-Executive Directors.
No loans or guarantees
In the year ended December 31, 2025, no loans or guarantees or the like were provided to the NEOs or the Non-
Executive Directors.
Key terms of equity plan applicable to grants in 2025
Stock options granted pursuant to the Equity Incentive Plan shall vest over a 36-month period, with 12/36ths of the total
grant vesting on the first anniversary of the grant date and the remaining 24/36ths vesting in equal monthly installments
of 1/36th each month thereafter. The number of Stock Options that vest on each vesting date is rounded to the nearest
whole number. Fractions below 0.5000 are rounded down, while fractions of 0.5000 or above are rounded up. If
rounding down, the difference is added to the next vesting date; if rounding up, the difference is deducted from the next
vesting date. Any remaining unvested equity is fully vested on the final day of the applicable vesting period—36 months
98 | ||
for Stock Options, subject, in each case, to the plan participant’s continued employment or mandate. Stock options are
exercisable when vested, and in any case not after the stock option expiration date included in each individual stock
option grant, which is 10 years, or in the case of Belgian tax resident employees, at their election either 5 years or 10
years from the date of grant.
Each stock option shall be granted with an exercise price equal to the fair market value upon the date of grant and shall
have a term equal to five or 10 years from the date of grant. Plan participants may prefer to elect the five-year period as
this may limit their personal tax obligations in respect of the stock option in respect to the jurisdiction where stock
options are taxed at grant, compared to a ten-year stock option. Stock options granted to Belgian tax resident
beneficiaries (including the CEO) are not exercisable prior to the fourth year following the year of the grant. More
specifically, stock options granted to an Executive Director cliff vests on the third anniversary of the grant date. Non-
Executive Directors are not eligible to receive any stock option grants.
RSUs granted under the Equity Incentive Plan shall vest over a period of four years with respect to one fourth of the
shares upon each anniversary of the date of grant. At the time of vesting, the holder of such RSUs receives shares in the
share capital of the Company for free equal to the number of RSUs vested minus a certain number of shares required to
cover employee taxes payable by us on behalf of the holder of RSUs, if applicable. Since 2025, RSUs are no longer
granted to the NEOs.
Any RSUs granted to Non-Executive Directors in 2025 vested after one year instead of four years and are subject to a
three-year holding period. In accordance with our 2025 Remuneration Policy, any RSUs granted in 2026 and beyond to
Non-Executive Directors are not subject to any vesting conditions and the shares must be held until the fourth
anniversary of the grant date, except to the extent necessary to cover immediate tax obligations resulting from the
immediate vest.
Since 2025, PSUs are granted to NEOs under the Equity Incentive Plan. PSUs cliff vest at the end of their three-year
performance period. Pay-out levels depend upon the achievement of the Executive Director’s measures relative to the
threshold, target and maximum levels that were determined by the Board.
Unvested equity incentives shall vest in the event of a (i) sale, merger, consolidation, tender offer or similar acquisition
of shares or other transaction or series of related transactions as a result of which a change in control occurs, (ii) sale or
other disposition of all or substantially all of the Company’s assets or (iii) the Company’s dissolution and/or liquidation.
The Board of Directors, upon approval of a majority of the Non-Executive Directors, may amend or terminate the Equity
Incentive Plan or may amend the terms of the Equity Incentive Plan, or any outstanding stock options or RSUs, provided
that the Company will compensate any affected individual for any direct negative impact of such amendment.
99 | ||
Summary of NEO Remuneration
(in $) | Base pay1) | Base pay in % change vs the prior year1) | Sign on bonus | Corporate bonus2) | Variable short-term incentive | Variable cash as % of target opportunity | Compensation in the form of stock options3) | Compensation in the form of RSUs | Compensation in the form of PSUs | Pension benefits4) | Fringe benefits5) | Other benefits6) | % fixed (of total)7) | Total | ||||||||||||||
CEO - Tim Van Hauwermeiren8) 11) | ||||||||||||||||||||||||||||
2025 | 827,160 | 5% | — | — | 744,444 | 60% | 2,941,497 | — | 2,856,448 | 44,168 | 16,054 | — | 12% | 7,429,771 | ||||||||||||||
2024 | 757,680 | 15% | — | — | 795,563 | 60% | 3,194,813 | 3,014,500 | — | 29,118 | 16,112 | — | 10% | 7,807,786 | ||||||||||||||
2023 | 655,787 | —% | — | — | 590,215 | 60% | 8,084,605 | 2,575,174 | — | 22,821 | 16,233 | — | 6% | 11,944,835 | ||||||||||||||
CFO - Karl Gubitz | ||||||||||||||||||||||||||||
2025 | 578,000 | 5% | — | 4,690 | 346,800 | 40% | 1,562,679 | — | 1,675,670 | 21,000 | 46,514 | 3,466 | 15% | 4,238,819 | ||||||||||||||
2024 | 553,000 | 7% | — | 3,636 | 331,800 | 40% | 2,018,973 | 2,100,610 | — | 13,800 | 40,832 | 205,939 | 15% | 5,268,590 | ||||||||||||||
2023 | 516,043 | 6% | — | 3,556 | 260,866 | 40% | 2,626,062 | 1,287,587 | — | 11,600 | 30,597 | 20,601 | 12% | 4,756,913 | ||||||||||||||
COO - Karen Massey9) 12) | ||||||||||||||||||||||||||||
2025 | 741,641 | 4% | — | 4,708 | 648,936 | 50% | 1,792,860 | — | 1,922,836 | 181,337 | 184,738 | 843,989 | 31% | 6,321,045 | ||||||||||||||
2024 | 655,657 | 37% | — | 3,636 | 573,593 | 50% | 2,018,973 | 2,100,610 | — | 165,394 | 57,348 | 619,272 | 24% | 6,194,483 | ||||||||||||||
2023 | 481,471 | N/A | 338,000 | 2,921 | 467,662 | 50% | 3,939,093 | 2,296,517 | — | 56,550 | 35,100 | 35,743 | 8% | 7,653,057 | ||||||||||||||
COO - Keith Woods10) | ||||||||||||||||||||||||||||
2023 | 305,022 | (48)% | — | — | — | —% | — | — | — | 11,600 | 34,434 | — | 100% | 351,056 | ||||||||||||||
1)The base pay of the CEO is paid in EUR and the base pay of the COO is paid in CHF. For 2025, the base pay exchange rate used in this table is 1.13 EUR/USD and 1.21 CHF/USD.
2)All employees are eligible to annually earn a performance based corporate bonus with a maximum value of €3,622 ($4,690) per year, based on three equally weighted Company-wide goals. In 2025, the
targets focused on (i) our commitment to cybersecurity, (ii) building argenx together, and (iii) simplification and digitalization. A maximum pay-out was made to all employees in 2025. The CEO does
not receive the corporate bonus.
3)Amounts shown represent the expenses with respect to stock options measured using the Black-Scholes model. For a description of the assumptions used in valuing these awards, see “Note 13 — Share-
Based Payments” to our Consolidated Financial Statements which are included to our Annual Report for the period December 31, 2025..
4)Pension benefits include employer pension contributions.
5)Fringe benefits include company car costs, employer-paid medical insurance premiums, lunch allowances and representation allowances. pension contributions, social security costs and other
allowances.
6)Other benefits consists of social security costs, other allowances and benefits. Employer social security costs were impacted by the increase of share-price at year end against the share-price as of
December 31, 2025.
7)Fixed compensation is considered as base pay, pension benefits, fringe benefits and other benefits.
8)Based on the approved 2025 equity allocation scheme, the total equity target value for Tim Van Hauwermeiren is equal to $5,790,000. The CEO received its equity grants at target value converted into a
number of stock options and PSUs on the Reference Date of the 30-days average share price of $569.17 per share preceding the Reference Date and the Black-Scholes model fair market value of
$192.65 per stock option. This results in the number of stock options and PSUs shown above. The amounts shown above represent the actual value received at the grant date of June 30, 2025 at which
date the Company’s share price was equal to $561.74. The difference in the price per share is explained by the stock price movement in the intervening period. For more information on the CEO equity
grant, please refer to “Item 6. B. — Compensation — Equity — Determination of target value of CEO equity grant” included in “Equity“ above. The fair market value based on the Black-Scholes model
for Tim Van Hauwermeiren is $195.75. These amounts do not reflect the actual economic value realized by the beneficiary. Amounts shown represent the expenses with respect to the stock options
awards granted in 2025 measured using the Black-Scholes model with unobservable assumptions. The assumptions used in the fair valuation differ between Belgian beneficiary versus non-Belgian
beneficiary. For a description of the assumptions used in valuing these awards, see “Note 13 — Share-Based Payments“ to our Consolidated Financial Statements which are included to our Annual
Report for the period ended December 31, 2025.
9)Karen Massey joined as COO in March 2023, and consequently no comparison to 2022 is available. Ms. Massey’s remuneration shows the remuneration paid for the period March 13, 2023 through
December 31, 2023. Her 2023 variable pay pay-out has been pro-rated to reflect this as well. The increase year over year for 2024 is not representative as it is comparing to a partial work year. In 2023,
the Company paid a sign-on bonus to Karen Massey to allow the Company to make an overall competitive offer of employment and in recognition of lost corporate benefits as a result of early departure
at Ms. Massey’s previous employer. Ensuring a competitive offer in this way and securing Ms. Massey as the Company’s new COO was deemed by the Board of Directors to be in the best interest of the
Company and its stakeholders.
10)Keith Woods resigned as COO March 2023 and his employment relationship ended on June 30, 2023 and consequently the remuneration numbers show his remuneration for the period January 1, 2023
through June 30, 2023. No equity award or variable pay was paid to Mr. Woods in the year ended December 31, 2023.
11)Tim Van Hauwermeiren will transition from his current CEO role to the position of Non-Executive chairperson of the Board of Directors, subject to shareholder approval at the 2026 General Meeting.
12)It is envisaged that Karen Massey, our current COO, will be appointed as an Executive Director at the 2026 General Meeting and subsequently elected as CEO by the Board of Directors.
100 | ||
Stock option overview
The table below shows (i) the stock options held as of January 1, 2025, (ii) the stock options granted to the NEOs which vested during the year ended December 31,
2025, (iii) the number of stock options scheduled to vest in the years ending December 31, 2026, December 31, 2027 and December 31, 2028 and (iv) the respective
exercise price of such stock options. Each stock option was granted pursuant to the Equity Incentive Plan.
For the CEO, under the 2021 Remuneration Policy, 1/3rd of the stock options vests on the first anniversary of the date of grant and the remaining 2/3rd vest in
monthly installments (24 in total) over the next two years, each time upon the 1st day of each next month. For the CEO, under the new 2025 Remuneration Policy all
stock options granted as of 2026 will vest on the third anniversary of the date of grant.
Information regarding the reported financial year | ||||||||||||||||||||||||||||||||
Opening Balance | During the Year | Closing balance | ||||||||||||||||||||||||||||||
Name of Directors, Position | Specification plan | Performance Period | Award Date | Vesting date | End of retention period | Exercise Period | Exercise price of stock option (€) | Stock options held at the beginning of the period | Stock options awarded | Stock options exercised | Stock options forfeited | Stock options vested | Stock options subjected to a service period | Stock options awarded and unvested | Stock options held at the end of the year | Stock options subjected to a retention period | ||||||||||||||||
Tim Van Hauwermeiren, CEO | Equity incentive plan | 21/12/2018 - 01/12/2021 | 21/12/2018 | (1) | 31/12/2021 | 01/01/2022 - 21/12/2028 | 86.32 | 80,000 | — | — | — | — | — | — | 80,000 | — | ||||||||||||||||
20/12/2019 - 01/12/2022 | 20/12/2019 | (1) | 31/12/2022 | 01/01/2023 - 20/12/2029 | 135.75 | 80,000 | — | — | — | — | — | — | 80,000 | — | ||||||||||||||||||
21/12/2020 - 01/12/2023 | 21/12/2020 | (1) | 31/12/2023 | 01/01/2024 - 21/12/2030 | 247.60 | 50,000 | — | — | — | — | — | — | 50,000 | — | ||||||||||||||||||
24/12/2021 - 01/12/2024 | 24/12/2021 | (1) | 31/12/2024 | 01/01/2025 - 24/12/2031 | 309.20 | 25,000 | — | — | — | — | — | — | 25,000 | — | ||||||||||||||||||
23/12/2022 - 01/12/2025 | 23/12/2022 | (1) | 31/12/2025 | 01/01/2026 - 23/12/2032 | 359.60 | 25,000 | — | — | — | 8,333 | — | — | 25,000 | — | ||||||||||||||||||
03/07/2023 - 01/07/2026 | 03/07/2023 | (1) | 31/12/2026 | 01/01/2027 - 03/07/2033 | 355.40 | 30,000 | — | — | — | 10,000 | 5,833 | 5,833 | 30,000 | 30,000 | ||||||||||||||||||
28/06/2024 - 01/06/2027 | 28/06/2024 | (1) | 31/12/2027 | 01/01/2028 - 28/06/2034 | 416.40 | 18,279 | — | — | — | 9,139 | 9,140 | 9,140 | 18,279 | 18,279 | ||||||||||||||||||
30/06/2025 - 01/06/2028 | 30/06/2025 | (1) | 31/12/2028 | 01/01/2029 - 30/06/2035 | 479.30 | — | 15,027 | — | — | — | 15,027 | 15,027 | 15,027 | 15,027 | ||||||||||||||||||
Total | 308,279 | 15,027 | — | — | 27,472 | 30,000 | 30,000 | 323,306 | 63,306 | |||||||||||||||||||||||
Karl Gubitz, CFO | Equity incentive plan | 01/07/2021 - 01/07/2024 | 01/07/2021 | (1) | N/A | 01/07/2022 - 01/07/2031 | 255.10 | 24,000 | — | 24,000 | — | — | — | — | — | — | ||||||||||||||||
01/07/2022 - 01/07/2025 | 01/07/2022 | (1) | N/A | 01/07/2023 - 01/07/2032 | 357.50 | 16,000 | — | — | — | 3,111 | — | — | 16,000 | — | ||||||||||||||||||
03/07/2023 - 01/07/2026 | 03/07/2023 | (1) | N/A | 03/07/2024 - 03/07/2033 | 355.40 | 15,000 | — | — | — | 5,000 | 2,917 | 2,917 | 15,000 | — | ||||||||||||||||||
28/06/2024 - 01/06/2027 | 28/06/2024 | (1) | N/A | 28/06/2025 - 28/06/2034 | 416.40 | 12,738 | — | — | — | 6,369 | 6,369 | 6,369 | 12,738 | — | ||||||||||||||||||
30/06/2025 - 01/06/2028 | 30/06/2025 | (1) | N/A | 01/01/2029 - 30/06/2035 | 479.30 | — | 8,812 | — | — | — | 8,812 | 8,812 | 8,812 | — | ||||||||||||||||||
Total | 67,738 | 8,812 | 24,000 | — | 14,480 | 18,098 | 18,098 | 52,550 | — | |||||||||||||||||||||||
Karen Massey, COO | Equity incentive plan | 03/07/2023 - 01/07/2026 | 03/07/2023 | (1) | N/A | 03/07/2024 - 03/07/2033 | 355.40 | 22,500 | — | 12,000 | — | 7,500 | 4,375 | 4,375 | 10,500 | — | ||||||||||||||||
28/06/2024 - 01/06/2027 | 28/06/2024 | (1) | N/A | 28/06/2025 - 28/06/2034 | 416.40 | 12,738 | — | — | — | 6,369 | 6,369 | 6,369 | 12,738 | — | ||||||||||||||||||
30/06/2025 - 01/06/2028 | 30/06/2025 | (1) | N/A | 01/01/2029 - 30/06/2035 | 479.30 | — | 10,110 | — | — | — | 10,110 | 10,110 | 10,110 | — | ||||||||||||||||||
Total | 35,238 | 10,110 | 12,000 | — | 13,869 | 20,854 | 20,854 | 33,348 | 3 3 , 3 4 8 | — | ||||||||||||||||||||||
1)1/3rd of the stock options vests on the first anniversary of the date of grant and the remaining 2/3rd vest in equal installments (24 in total) over the next two years, each time upon the 1st day of each next
month.
101 | ||
PSU overview
The table below shows (i) the PSUs held as of January 1, 2025, (ii) the PSUs granted to the NEOs which vested during the year ended December 31, 2025 and (iii)
the number of PSUs scheduled to vest in the years ending December 31, 2026, December 31, 2027 and December 31, 2028. Each PSU was granted pursuant to the
Equity Incentive Plan:
Information regarding the reported financial year | ||||||||||||||||||||||||
The main conditions of PSU plan | Opening balance | During the Year | Closing balance | |||||||||||||||||||||
Name of Directors, Position | Vesting period | Award Date | Vesting date | End of retention period | PSUs held at the beginning of the year | PSUs awarded | PSU Forfeited | PSUs vested | PSUs subject to a service condition | PSUs awarded and unvested | PSUs held at the closing of the year | PSUs subject to a retention period | ||||||||||||
Tim van Hauwermeiren, CEO | 01/01/2025 - 31/12/2027 | 30/06/2025 | 31/12/2027 | N/A | – | 5,085 | – | – | – | 5,085 | 5,085 | – | ||||||||||||
Total | – | 5,085 | – | – | – | 5,085 | 5,085 | – | ||||||||||||||||
Karl Gubitz, CFO | 01/01/2025 - 31/12/2027 | 30/06/2025 | 31/12/2027 | N/A | – | 2,983 | – | – | – | 2,983 | 2,983 | – | ||||||||||||
Total | – | 2,983 | – | – | – | 2,983 | 2,983 | – | ||||||||||||||||
Karen Massey, COO | 01/01/2025 - 31/12/2027 | 30/06/2025 | 31/12/2027 | N/A | – | 3,423 | – | – | – | 3,423 | 3,423 | – | ||||||||||||
Total | – | 3,423 | – | – | – | 3,423 | 3,423 | – | ||||||||||||||||
102 | ||
RSU overview
The table below shows (i) the RSUs held as of January 1, 2025, (ii) the RSUs granted to the NEOs which vested during the year ended December 31, 2025 and (iii)
the number of RSUs scheduled to vest in the years ending December 31, 2026, December 31, 2027, December 31, 2028 and December 31, 2029. As of 2025, RSUs
were no longer granted to the NEOs and replaced by PSUs. Each RSU was granted pursuant to the Equity Incentive Plan:
Information regarding the reported financial year | ||||||||||||||||||||||||
The main conditions of RSU plan | Opening balance | During the Year | Closing balance | |||||||||||||||||||||
Name of Directors, Position | Vesting period | Award Date | Vesting date | End of retention period | RSUs held at the beginning of the year | RSUs awarded | RSU Forfeited | RSUs vested | RSUs subject to a service condition | RSUs awarded and unvested | RSUs held at the closing of the year | RSUs subject to a retention period | ||||||||||||
Tim van Hauwermeiren, CEO | 24/12/2021 - 24/12/2025 | 24/12/2021 | (1) | N/A | 1,425 | — | — | 1,425 | — | — | — | — | ||||||||||||
23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | N/A | 2,850 | — | — | 1,425 | — | 1,425 | 1,425 | — | |||||||||||||
03/07/2023 - 03/07/2027 | 07/03/2023 | (1) | N/A | 5,025 | — | — | 1,675 | — | 3,350 | 3,350 | — | |||||||||||||
28/06/2024 - 28/06/2028 | 28/06/2024 | (1) | N/A | 6,762 | — | — | 1,690 | — | 5,072 | 5,072 | — | |||||||||||||
Total | 16,062 | — | — | 6,215 | — | 9,847 | 9,847 | — | ||||||||||||||||
Karl Gubitz, CFO | 01/07/2021 - 01/07/2025 | 01/07/2021 | (1) | N/A | 1,350 | — | — | 1,350 | — | — | — | — | ||||||||||||
01/07/2022 - 01/07/2026 | 01/07/2022 | (1) | N/A | 1,800 | — | — | 900 | — | 900 | 900 | — | |||||||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | N/A | 2,513 | — | — | 838 | — | 1,675 | 1,675 | — | |||||||||||||
28/06/2024 - 28/06/2028 | 28/06/2024 | (1) | N/A | 4,712 | — | — | 1,178 | — | 3,534 | 3,534 | — | |||||||||||||
Total | 10,375 | — | — | 4,266 | — | 6,109 | 6,109 | — | ||||||||||||||||
Karen Massey, COO | 03/07/2023 - 03/07/2027 | 07/03/2023 | (1) | N/A | 3,769 | — | — | 1,256 | — | 2,513 | 2,513 | — | ||||||||||||
28/06/2024 - 28/06/2028 | 28/06/2024 | (1) | N/A | 4,712 | — | — | 1,178 | — | 3,534 | 3,534 | — | |||||||||||||
Total | 8,481 | — | — | 2,434 | — | 6,047 | 6,047 | — | ||||||||||||||||
1) RSUs vest over a period of four years with 1/4th of the total grant vesting at each anniversary of the date of grant.
103 | ||
Remuneration of Other Members of the Senior Management Team
For the purposes of U.S. governance reporting requirements, all senior level employees reporting directly to the CEO
qualify as the Company’s ‘executives’. The remuneration disclosures in relation to this more extensive group of senior
personnel (excluding the NEOs) in this 2025 Remuneration Report is presented on an aggregated basis, with the
exception of equity remuneration, which is presented on an individual basis.
Aggregate compensation for other members of the Senior Management Team
The following table sets forth information regarding aggregate compensation paid to members of the Senior
Management Team (other than the NEOs) during the year ended December 31, 2025.
(in $) | Compensation | |
Base pay | 3,138,512 | |
Variable STI1) | 1,526,247 | |
Compensation in the form of stock options | 10,521,797 | |
Compensation in the form of PSUs | 7,443,617 | |
Pension benefits2) | 80,045 | |
Fringe benefits3) | 107,679 | |
Other benefits4) | 3,187,985 | |
Total | 26,005,882 |
1)Variable STI includes a performance based Company wide corporate bonus of €3,622 ($4,690) per member of the Senior Management Team.
2)Pension benefits include employer pension contributions.
3)Fringe benefits include company car costs, employer-paid medical insurance premiums, lunch allowances and representation allowances. pension
contributions, social security costs and other allowances.
4)Other benefits consists of social security costs, other allowances and benefits. Employer social security costs were impacted by the increase of
share-price at year end against the share-price as of December 31, 2025.
For more information on equity granted to members of the Senior Management Team (other than the NEOs), during
2025, please refer to “Item 6.B. — Compensation — Summary of Other members of the Senior Management Team”
below.
104 | ||
Summary of other members of the Senior Management Team
Stock options overview other members of the Senior Management Team
The following table sets forth information regarding stock option and PSU awards granted to members of the Senior Management Team during the year ended
December 31, 2025:
PSUs granted in 2025 | Stock options granted in 2025 | |||||||||||
Name | # PSUs | Key terms | # Stock options | Exercise price in € | Exercise price in $ | Key terms | ||||||
Arjen Lemmen | 3,423 | PSUs are subject to a cliff vest and settlement at the end of a performance period of 3-years. | 10,110 | 479.30 | 561.74 | 1/3 vests after year 1 2/3 vest in monthly installments in year 2 and 3. | ||||||
Malini Moorthy | 2,983 | 8,812 | 479.30 | 561.74 | ||||||||
Luc Truyen | 2,983 | 8,812 | 479.30 | 561.74 | ||||||||
Peter Ulrichts | 2,983 | 8,812 | 479.30 | 561.74 | ||||||||
Andria Wilk | 879 | 2,596 | 479.30 | 561.74 | ||||||||
The table below shows (i) the stock options held as of January 1, 2025, (ii) the stock options granted to members of Senior Management Team (other than the NEOs)
which vested during the year ended December 31, 2025, (iii) the number of stock options scheduled to vest in the years ending December 31, 2026, December 31,
2027 and December 31, 2028 and (iv) the respective exercise price of such stock options. Each stock option was granted pursuant to the Equity Incentive Plan:
105 | ||
Information regarding the reported financial year | ||||||||||||||||||||||||
Opening balance | During the Year | Closing balance | ||||||||||||||||||||||
Name of Directors, Position | Specification plan | Performance period | Award date | Vesting date | Exercise period | Exercise price of stock option in € | Stock options held at the beginning of the year | Stock options awarded | Stock options exercised | Stock options forfeited | Stock options vested | Stock options held at the end of the year | ||||||||||||
Arjen Lemmen, Vice President of Corporate Development & Strategy | Equity incentive plan | 21/12/2020 - 01/12/2023 | 21/12/2020 | (1) | 01/01/2024 - 21/12/2030 | 247.60 | 47,674 | — | 32,674 | — | — | 15,000 | ||||||||||||
24/12/2021 - 01/12/2024 | 24/12/2021 | (1) | 01/01/2025 - 24/12/2031 | 309.20 | 16,000 | — | — | — | — | 16,000 | ||||||||||||||
23/12/2022 - 01/12/2025 | 23/12/2022 | (1) | 23/12/2023 - 23/12/2032 | 359.60 | 16,000 | — | — | — | 5,333 | 16,000 | ||||||||||||||
03/07/2023 - 01/07/2026 | 03/07/2023 | (1) | 03/07/2024 - 03/07/2033 | 355.40 | 15,000 | — | — | — | 5,000 | 15,000 | ||||||||||||||
28/06/2024 - 01/06/2027 | 28/06/2024 | (1) | 01/01/2028 - 28/06/2034 | 416.40 | 12,738 | — | — | — | 6,369 | 12,738 | ||||||||||||||
30/06/2025 - 01/06/2028 | 30/06/2025 | (1) | 01/01/2029 - 30/06/2035 | 479.30 | — | 10,110 | — | — | — | 10,110 | ||||||||||||||
Total | 107,412 | 10,110 | 32,674 | — | 16,702 | 84,848 | ||||||||||||||||||
Malini Moorthy, Legal Counsel | Equity incentive plan | 01/04/2022 - 01/04/2025 | 01/04/2022 | (1) | 01/04/2023 - 01/04/2032 | 282.50 | 6,500 | — | 6,500 | — | 2,667 | — | ||||||||||||
03/07/2023 - 01/07/2026 | 03/07/2023 | (1) | 03/07/2024 - 03/07/2033 | 355.40 | 15,000 | — | 5,000 | — | 5,000 | 10,000 | ||||||||||||||
28/06/2024 - 01/06/2027 | 28/06/2024 | (1) | 01/01/2028 - 28/06/2034 | 416.40 | 12,738 | — | — | — | 6,369 | 12,738 | ||||||||||||||
30/06/2025 - 01/06/2028 | 30/06/2025 | (1) | 01/01/2029 - 30/06/2035 | 479.30 | — | 8,812 | — | — | — | 8,812 | ||||||||||||||
Total | 34,238 | 8,812 | 11,500 | — | 14,036 | 31,550 | ||||||||||||||||||
Luc Truyen, CMO | Equity incentive plan | 01/10/2021 - 01/10/2024 | 01/10/2021 | (1) | 01/01/2025 - 01/10/2026 | 259.5 | 24,000 | — | 24,000 | — | — | — | ||||||||||||
23/12/2022 - 01/12/2025 | 23/12/2022 | (1) | 01/01/2026 - 23/12/2027 | 359.6 | 16,000 | — | — | — | 5,333 | 16,000 | ||||||||||||||
03/07/2023 - 01/07/2026 | 03/07/2023 | (1) | 01/01/2027 - 03/07/2028 | 355.4 | 15,000 | — | — | — | 5,000 | 15,000 | ||||||||||||||
28/06/2024 - 01/06/2027 | 28/06/2024 | (1) | 01/01/2028 - 28/06/2034 | 416.40 | 12,738 | — | — | — | 6,369 | 12,738 | ||||||||||||||
30/06/2025 - 01/06/2028 | 30/06/2025 | (1) | 01/01/2029 - 30/06/2035 | 479.30 | — | 8,812 | — | — | — | 8,812 | ||||||||||||||
Total | 67,738 | 8,812 | 24,000 | — | 16,702 | 52,550 | ||||||||||||||||||
Peter Ulrichts, CSO | Equity incentive plan | 20/12/2019 - 01/12/2022 | 20/12/2019 | (1) | 01/01/2023 - 20/12/2029 | 135.75 | 4,000 | — | 4,000 | — | — | — | ||||||||||||
21/12/2020 - 01/12/2023 | 21/12/2020 | (1) | 01/01/2024 - 21/12/2030 | 247.60 | 7,651 | — | 7,651 | — | — | — | ||||||||||||||
24/12/2021 - 01/12/2024 | 24/12/2021 | (1) | 01/01/2025 - 24/12/2026 | 309.20 | 3,420 | — | 3,420 | — | — | — | ||||||||||||||
23/12/2022 - 01/12/2025 | 23/12/2022 | (1) | 01/01/2026 - 23/12/2027 | 359.60 | 16,000 | — | — | — | 3,811 | 16,000 | ||||||||||||||
03/07/2023 - 01/07/2026 | 03/07/2023 | (1) | 01/01/2027 - 03/07/2028 | 355.40 | 15,000 | — | — | — | 5,000 | 15,000 | ||||||||||||||
28/06/2024 - 01/06/2027 | 28/06/2024 | (1) | 01/01/2028 - 28/06/2034 | 416.40 | 12,738 | — | — | — | 4,978 | 12,738 | ||||||||||||||
30/06/2025 - 01/06/2028 | 30/06/2025 | (1) | 01/01/2029 - 30/06/2035 | 479.30 | — | 8,812 | — | — | 1,039 | 8,812 | ||||||||||||||
Total | 58,809 | 8,812 | 15,071 | — | 14,828 | 52,550 | ||||||||||||||||||
Andria Wilk, Global Head of Quality | Equity incentive plan | 21/12/2020 - 01/12/2023 | 21/12/2020 | (1) | 01/01/2024 - 21/12/2025 | 247.60 | 87 | — | 87 | — | — | — | ||||||||||||
24/12/2021 - 01/12/2024 | 24/12/2021 | (1) | 01/01/2025 - 24/12/2031 | 309.20 | 4,446 | — | 1,167 | — | — | 3,279 | ||||||||||||||
23/12/2022 - 01/12/2025 | 23/12/2022 | (1) | 01/01/2026 - 23/12/2027 | 359.60 | 4,600 | — | — | — | 1,126 | 4,600 | ||||||||||||||
03/07/2023 - 01/07/2026 | 03/07/2023 | (1) | 01/01/2027 - 03/07/2033 | 355.40 | 4,600 | — | — | — | 1,276 | 4,600 | ||||||||||||||
28/06/2024 - 01/06/2027 | 28/06/2024 | (1) | 01/01/2028 - 28/06/2034 | 416.40 | 3,599 | — | — | — | 1,406 | 3,599 | ||||||||||||||
30/06/2025 - 01/06/2028 | 30/06/2025 | (1) | 01/01/2029 - 30/06/2035 | 479.30 | — | 2,596 | — | — | 306 | 2,596 | ||||||||||||||
Total | 17,332 | 2,596 | 1,254 | — | 4,114 | 18,674 | ||||||||||||||||||
1)1/3rd of the stock options vests on the first anniversary of the date of grant and the remaining 2/3rd vest in equal installments (24 in total) over the next two years, each time upon the 1st day of each next
month.
106 | ||
PSU overview other members of the Senior Management Team
The table below shows (i) the PSUs held as of January 1, 2025, (ii) the PSUs granted to members of Senior Management Team (other than the NEOs) which vested
during the year ended December 31, 2025 and (iii) the number of PSUs scheduled to vest in the years ending December 31, 2026, December 31, 2027 and December
31, 2028. Each PSU was granted pursuant to the Equity Incentive Plan:
Information regarding the reported financial year | ||||||||||||||||
Main conditions of the PSU plan | Opening balance | During the Year | Closing balance | |||||||||||||
Name of Directors, Position | Performance period | Award date | Vesting date | PSU’s held at the beginning of the year | PSUs awarded | PSUs forfeited | PSUs vested | PSUs held at the closing of the year | ||||||||
Arjen Lemmen, Vice President of Corporate Development & Strategy | 01/01/2025 - 31/12/2027 | 30/06/2025 | 31/12/2027 | — | 3,423 | — | — | 3,423 | ||||||||
Total | — | 3,423 | — | — | 3,423 | |||||||||||
Malini Moorthy, General Counsel and Corporate Secretary | 01/01/2025 - 31/12/2027 | 30/6/2025 | 31/12/2027 | — | 2,983 | — | — | 2,983 | ||||||||
Total | — | 2,983 | — | — | 2,983 | |||||||||||
Luc Truyen, CMO | 01/01/2025 - 31/12/2027 | 30/6/2025 | 31/12/2027 | — | 2,983 | — | — | 2,983 | ||||||||
Total | — | 2,983 | — | — | 2,983 | |||||||||||
Peter Ulrichts, CSO | 01/01/2025 - 31/12/2027 | 30/6/2025 | 31/12/2027 | — | 2,983 | — | — | 2,983 | ||||||||
Total | — | 2,983 | — | — | 2,983 | |||||||||||
Andria Wilk, Global Head of Quality | 01/01/2025 - 31/12/2027 | 30/6/2025 | 31/12/2027 | — | 879 | — | — | 879 | ||||||||
Total | — | 879 | — | — | 879 | |||||||||||
RSU overview other members of the Senior Management Team
The table below shows (i) the RSUs held as of January 1, 2025, (ii) the RSUs granted to members of Senior Management Team (other than the NEOs) which vested
during the year ended December 31, 2025 and (iii) the number of RSUs scheduled to vest in the years ending December 31, 2026, December 31, 2027, December 31,
2028 and December 31, 2029. As of 2025, RSUs were no longer granted to the other members of the Senior Management Team and replaced by PSUs. Each RSU
was granted pursuant to the Equity Incentive Plan:
107 | ||
Information regarding the reported financial year | ||||||||||||||||
The main conditions of the RSU plan | Opening balance | During the Year | Closing balance | |||||||||||||
Name of Directors, Position | Vesting period | Award date | Vesting date | RSU’s held at the beginning of the year | RSUs awarded | RSUs forfeited | RSUs vested | RSUs held at the closing of the year | ||||||||
Arjen Lemmen, Vice President of Corporate Development & Strategy | 24/12/2021 - 24/12/2025 | 24/12/2021 | (1) | 900 | — | — | 900 | — | ||||||||
23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | 1,800 | — | — | 900 | 900 | |||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | 2,513 | — | — | 838 | 1,675 | |||||||||
28/06/2024 - 27/06/2028 | 28/06/2024 | (1) | 4,712 | — | — | 1,178 | 3,534 | |||||||||
Total | 9,925 | — | — | 3,816 | 6,109 | |||||||||||
Malini Moorthy, General Counsel and Corporate Secretary | 01/04/2022 - 01/04/2026 | 01/04/2022 | (1) | 2,700 | — | — | 1,350 | 1,350 | ||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | 2,513 | — | — | 838 | 1,675 | |||||||||
28/06/2024 - 27/06/2028 | 28/06/2024 | (1) | 4,712 | — | — | 1,178 | 3,534 | |||||||||
Total | 9,925 | — | — | 3,366 | 6,559 | |||||||||||
Luc Truyen, CMO | 01/10/2021 - 01/10/2025 | 01/10/2021 | (1) | 1,350 | — | — | 1,350 | — | ||||||||
23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | 1,800 | — | — | 900 | 900 | |||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | 2,513 | — | — | 838 | 1,675 | |||||||||
28/06/2024 - 27/06/2028 | 28/06/2024 | (1) | 4,712 | — | — | 1,178 | 3,534 | |||||||||
Total | 10,375 | — | — | 4,266 | 6,109 | |||||||||||
Peter Ulrichts, CSO | 24/12/2021 - 24/12/2025 | 24/12/2021 | (1) | 190 | — | — | 190 | — | ||||||||
23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | 1,800 | — | — | 900 | 900 | |||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | 2,513 | — | — | 838 | 1,675 | |||||||||
28/06/2024 - 27/06/2028 | 28/06/2024 | (1) | 4,712 | — | — | 1,178 | 3,534 | |||||||||
Total | 9,215 | — | — | 3,106 | 6,109 | |||||||||||
Andria Wilk, Global Head of Quality | 24/12/2021 - 24/12/2025 | 24/12/2021 | (1) | 247 | — | — | 247 | — | ||||||||
23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | 500 | — | — | 250 | 250 | |||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | 750 | — | — | 250 | 500 | |||||||||
28/06/2024 - 27/06/2028 | 28/06/2024 | (1) | 1,331 | — | — | 333 | 998 | |||||||||
Total | 2,828 | — | — | 1,080 | 1,748 | |||||||||||
1)RSUs vest over a period of four years with 1/4th of the total grant vesting at each anniversary of the date of grant.
108 | ||
Summary of Non-Executive Director Equity compensation
RSU overview Non-Executive Directors
Information regarding the reported financial year | ||||||||||||||||||||
The main conditions of RSU plan | Opening balance | During the Year | Closing balance | |||||||||||||||||
Name of member of Board of Directors | Vesting period | Award date | Vesting date | End of holding period | RSUs held at the beginning of the year | RSUs awarded | RSUs vested | RSUs subject to a service condition | RSUs awarded and unvested | RSUs held at the closing of the year | ||||||||||
Ana Céspedes | 23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | N/A | 450 | — | 225 | — | 225 | 225 | ||||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | N/A | 131 | — | 43 | — | 88 | 88 | |||||||||||
28/06/2024 - 28/06/2025 | 28/06/2024 | (1) | 28/06/2028 | 1,065 | — | 1,065 | — | — | 1,065 | |||||||||||
30/06/2025 - 30/06/2026 | 30/06/2025 | (1) | 30/06/2029 | — | 703 | — | — | 703 | 703 | |||||||||||
Total | 1,646 | 703 | 1,333 | — | 1,016 | 2,081 | ||||||||||||||
James Daly | 24/12/2021 - 24/12/2025 | 24/12/2021 | (1) | N/A | 150 | — | 150 | — | — | — | ||||||||||
23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | N/A | 300 | — | 150 | — | 150 | 150 | |||||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | N/A | 263 | — | 88 | — | 175 | 175 | |||||||||||
28/06/2024 - 28/06/2025 | 28/06/2024 | (1) | 28/06/2028 | 1,065 | — | 1,065 | — | — | 1,065 | |||||||||||
30/06/2025 - 30/06/2026 | 30/06/2025 | (1) | 30/06/2029 | — | 703 | — | — | 703 | 703 | |||||||||||
Total | 1,778 | 703 | 1,453 | — | 1,028 | 2,093 | ||||||||||||||
Donald deBethizy2) | 24/12/2021 - 24/12/2025 | 24/12/2021 | (1) | N/A | 150 | — | 150 | — | — | — | ||||||||||
23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | N/A | 300 | — | 150 | — | 150 | 150 | |||||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | N/A | 263 | — | 263 | — | — | — | |||||||||||
28/06/2024 - 28/06/2025 | 28/06/2024 | (1) | 28/06/2028 | 1,065 | — | 1,065 | — | — | 1,065 | |||||||||||
Total | 1,778 | — | 1,628 | — | 150 | 1,215 | ||||||||||||||
Pamela Klein | 24/12/2021 - 24/12/2025 | 24/12/2021 | (1) | N/A | 300 | — | 150 | — | 150 | 150 | ||||||||||
23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | N/A | 450 | — | 150 | — | 300 | 300 | |||||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | N/A | 350 | — | 87 | — | 263 | 263 | |||||||||||
28/06/2024 - 28/06/2025 | 28/06/2024 | (1) | 28/06/2028 | 1,065 | — | 1,065 | — | — | 1,065 | |||||||||||
30/06/2025 - 30/06/2026 | 30/06/2025 | (1) | 30/06/2029 | — | 703 | — | — | 703 | 703 | |||||||||||
Total | 2,165 | 703 | 1,452 | — | 1,416 | 2,481 | ||||||||||||||
Brian Kotzin | 28/06/2024 - 28/06/2028 | 28/06/2024 | (1) | 28/06/2028 | 1,598 | — | 1,598 | — | — | 1,598 | ||||||||||
30/06/2025 - 30/06/2026 | 30/06/2025 | (1) | 30/06/2029 | — | 703 | — | — | 703 | 703 | |||||||||||
Total | 1,598 | 703 | 1,598 | — | 703 | 2,301 | ||||||||||||||
109 | ||
Information regarding the reported financial year | ||||||||||||||||||||
The main conditions of RSU plan | Opening balance | During the Year | Closing balance | |||||||||||||||||
Steve Krognes | 03/04/2023 - 03/04/2027 | 03/04/2023 | (1) | N/A | 394 | — | 132 | — | 262 | 262 | ||||||||||
28/06/2024 - 28/06/2025 | 28/06/2024 | (1) | 28/06/2028 | 1,065 | — | 1,065 | — | — | 1,065 | |||||||||||
30/06/2025 - 30/06/2026 | 30/06/2025 | (1) | 30/06/2029 | — | 703 | — | — | 703 | 703 | |||||||||||
Total | 1,459 | 703 | 1,197 | — | 965 | 2,030 | ||||||||||||||
Anthony Rosenberg | 24/12/2021 - 24/12/2025 | 24/12/2021 | (1) | N/A | 150 | — | 150 | — | — | — | ||||||||||
23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | N/A | 300 | — | 150 | — | 150 | 150 | |||||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | N/A | 263 | — | 88 | — | 175 | 175 | |||||||||||
28/06/2024 - 28/06/2025 | 28/06/2024 | (1) | 28/06/2028 | 1,065 | — | 1,065 | — | — | 1,065 | |||||||||||
30/06/2025 - 30/06/2026 | 30/06/2025 | (1) | 30/06/2029 | — | 703 | — | — | 703 | 703 | |||||||||||
Total | 1,778 | 703 | 1,453 | — | 1,028 | 2,093 | ||||||||||||||
Camilla Sylvest | 03/10/2022 - 03/10/2026 | 03/10/2022 | (1) | N/A | 450 | — | 225 | — | 225 | 225 | ||||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | N/A | 197 | — | 65 | — | 132 | 132 | |||||||||||
28/06/2024 - 28/06/2025 | 28/06/2024 | (1) | 28/06/2028 | 1,065 | — | 1,065 | — | — | 1,065 | |||||||||||
30/06/2025 - 30/06/2026 | 30/06/2025 | (1) | 30/06/2029 | — | 703 | — | — | 703 | 703 | |||||||||||
Total | 1,712 | 703 | 1,355 | — | 1,060 | 2,125 | ||||||||||||||
Peter Verhaeghe | 24/12/2021 - 24/12/2025 | 24/12/2021 | (1) | N/A | 150 | — | 150 | — | — | — | ||||||||||
23/12/2022 - 23/12/2026 | 23/12/2022 | (1) | N/A | 300 | — | 150 | — | 150 | 150 | |||||||||||
03/07/2023 - 03/07/2027 | 03/07/2023 | (1) | N/A | 263 | — | 88 | — | 175 | 175 | |||||||||||
28/06/2024 - 28/06/2025 | 28/06/2024 | (1) | 28/06/2028 | 1,065 | — | 1,065 | — | — | 1,065 | |||||||||||
30/06/2025 - 30/06/2026 | 30/06/2025 | (1) | 30/06/2029 | — | 703 | — | — | 703 | 703 | |||||||||||
Total | 1,778 | 703 | 1,453 | — | 1,028 | 2,093 | ||||||||||||||
1)RSUs granted before 2024 vest over a period of four years with 1/4th of the total grant vesting at each anniversary of the date of grant. RSUs granted to Non-Executive Directors in 2024 will all vest on
the 1st anniversary of the grant date in 2025 and are subject to a holding period of 3 years.
2)Donald deBethizy retired from the Board of Directors and the Research and Development Committee on May 27, 2025.
110 | ||
Stock Option overview Non-Executive Director
Information regarding the reported financial year | ||||||||||||||||||||||||||||
Opening balance | During the Year | Closing balance | ||||||||||||||||||||||||||
Name of Directors | Performance period | Award date | Vesting date | End of retention period | Exercise period | Exercise price of stock option (€) | Stock options held at the beginning of the year | Stock options awarded | Stock options exercised | Stock options vested | Stock options subject to a service condition | Stock options awarded and unvested | Stock options held at the end of the year | Stock options subject to a retention period | ||||||||||||||
Ana Céspedes | 23/12/2022 - 23/12/2025 | 23/12/2022 | (2) | 31/12/2025 | 23/12/2023 - 23/12/2032 | 359.60 | 4,050 | — | — | 4,050 | — | — | 4,050 | — | ||||||||||||||
03/07/2023 - 03/07/2026 | 03/07/2023 | (2) | 31/12/2026 | 03/07/2024 - 03/07/2033 | 355.40 | 800 | — | — | — | — | 800 | 800 | 800 | |||||||||||||||
Total | 4,850 | — | — | 4,050 | — | 800 | 4,850 | 800 | ||||||||||||||||||||
James Daly | 21/12/2020 - 21/12/2023 | 21/12/2020 | (1) | N/A | 21/12/2021 - 21/12/2030 | 247.60 | 10,000 | — | 10,000 | — | — | — | — | — | ||||||||||||||
24/12/2021 - 24/12/2024 | 24/12/2021 | (2) | 31/12/2024 | 24/12/2022 - 24/12/2031 | 309.20 | 2,700 | — | 2,700 | — | — | — | — | — | |||||||||||||||
23/12/2022 - 23/12/2025 | 23/12/2022 | (2) | 31/12/2025 | 23/12/2023 - 23/12/2032 | 359.60 | 2,700 | — | 2,700 | — | — | — | 2,700 | — | |||||||||||||||
03/07/2023 - 03/07/2026 | 03/07/2023 | (2) | 31/12/2026 | 03/07/2024 - 03/07/2033 | 355.40 | 1,600 | — | — | — | — | 1,600 | 1,600 | 1,600 | |||||||||||||||
Total | 17,000 | — | 15,400 | — | — | 1,600 | 4,300 | 1,600 | ||||||||||||||||||||
Donald deBethizy 3) | 18/06/2016 - 18/06/2019 | 18/06/2016 | (1) | N/A | 18/06/2017 - 18/06/2026 | 11.38 | 10,000 | — | — | — | — | — | 10,000 | — | ||||||||||||||
21/12/2018 - 21/12/2021 | 21/12/2018 | (1) | N/A | 21/12/2019 - 21/12/2028 | 86.32 | 10,000 | — | — | — | — | — | 10,000 | — | |||||||||||||||
20/12/2019 - 20/12/2022 | 20/12/2019 | (1) | N/A | 20/12/2020 - 20/12/2029 | 135.75 | 10,000 | — | — | — | — | — | 10,000 | — | |||||||||||||||
21/12/2020 - 21/12/2023 | 21/12/2020 | (1) | N/A | 21/12/2021 - 21/12/2030 | 247.60 | 10,000 | — | — | — | — | — | 10,000 | — | |||||||||||||||
24/12/2021 - 24/12/2024 | 24/12/2021 | (2) | 31/12/2024 | 24/12/2022 - 24/12/2031 | 309.20 | 2,700 | — | 2,700 | — | — | — | — | — | |||||||||||||||
23/12/2022 - 23/12/2025 | 23/12/2022 | (2) | 31/12/2025 | 23/12/2023 - 23/12/2032 | 359.60 | 2,700 | — | — | 2,700 | — | — | 2,700 | — | |||||||||||||||
03/07/2023 - 03/07/2026 | 03/07/2023 | (2) | 31/12/2026 | 03/07/2024 - 03/07/2033 | 355.40 | 1,600 | — | — | 1,600 | — | — | 1,600 | 1,600 | |||||||||||||||
Total | 47,000 | — | 2,700 | 4,300 | — | — | 44,300 | 1,600 | ||||||||||||||||||||
111 | ||
Information regarding the reported financial year | ||||||||||||||||||||||||||||
Opening balance | During the Year | Closing balance | ||||||||||||||||||||||||||
Name of Directors | Performance period | Award date | Vesting date | End of retention period | Exercise period | Exercise price of stock option (€) | Stock options held at the beginning of the year | Stock options awarded | Stock options exercised | Stock options vested | Stock options subject to a service condition | Stock options awarded and unvested | Stock options held at the end of the year | Stock options subject to a retention period | ||||||||||||||
Pamela Klein | 20/12/2019 - 20/12/2022 | 20/12/2019 | (1) | N/A | 20/12/2020 - 20/12/2029 | 135.75 | 7,500 | — | 5,000 | — | — | — | 2,500 | — | ||||||||||||||
21/12/2020 - 21/12/2023 | 21/12/2020 | (1) | N/A | 21/12/2021 - 21/12/2030 | 247.60 | 10,000 | — | — | — | — | — | 10,000 | — | |||||||||||||||
24/12/2021 - 24/12/2024 | 24/12/2021 | (2) | 31/12/2024 | 24/12/2022 - 24/12/2031 | 309.20 | 2,700 | — | — | — | — | — | 2,700 | — | |||||||||||||||
23/12/2022 - 23/12/2025 | 23/12/2022 | (2) | 31/12/2025 | 23/12/2023 - 23/12/2032 | 359.60 | 2,700 | — | — | 2,700 | — | — | 2,700 | — | |||||||||||||||
03/07/2023 - 03/07/2026 | 03/07/2023 | (2) | 31/12/2026 | 03/07/2024 - 03/07/2033 | 355.40 | 1,600 | — | — | — | — | 1,600 | 1,600 | 1,600 | |||||||||||||||
Total | 24,500 | — | 5,000 | 2,700 | — | 1,600 | 19,500 | 1,600 | ||||||||||||||||||||
Steve Krognes | 03/04/2023 - 03/04/2026 | 03/04/2023 | (2) | 31/12/2026 | 03/04/2024 - 03/04/2033 | 340.70 | 2,400 | — | — | — | — | 2,400 | 2,400 | 2,400 | ||||||||||||||
Total | 2,400 | — | — | — | — | 2,400 | 2,400 | 2,400 | ||||||||||||||||||||
Anthony Rosenberg | 13/12/2016 - 13/12/2019 | 13/12/2016 | (1) | N/A | 13/12/2017 - 13/12/2026 | 14.13 | 7,800 | — | 7,800 | — | — | — | — | — | ||||||||||||||
21/12/2018 - 21/12/2021 | 21/12/2018 | (1) | N/A | 21/12/2019 - 21/12/2028 | 86.32 | 10,000.00 | — | — | — | — | — | 10,000.00 | — | |||||||||||||||
20/12/2019 - 20/12/2022 | 20/12/2019 | (1) | N/A | 20/12/2020 - 20/12/2029 | 135.75 | 8,840 | — | — | — | — | — | 8,840 | — | |||||||||||||||
21/12/2020 - 21/12/2023 | 21/12/2020 | (1) | N/A | 21/12/2021 - 21/12/2030 | 247.60 | 3,640 | — | — | — | — | — | 3,640 | — | |||||||||||||||
24/12/2021 - 24/12/2024 | 24/12/2021 | (2) | 31/12/2024 | 24/12/2022 - 24/12/2031 | 309.20 | 2,700 | — | — | — | — | — | 2,700 | — | |||||||||||||||
23/12/2022 - 23/12/2025 | 23/12/2022 | (2) | 31/12/2025 | 23/12/2023 - 23/12/2032 | 359.60 | 2,700 | — | — | 2,700 | — | — | 2,700 | — | |||||||||||||||
03/07/2023 - 03/07/2026 | 03/07/2023 | (2) | 31/12/2026 | 03/07/2024 - 03/07/2033 | 355.40 | 1,600 | — | — | — | — | 1,600 | 1,600 | 1,600 | |||||||||||||||
Total | 37,280 | — | 7,800 | 2,700 | — | 1,600 | 29,480 | 1,600 | ||||||||||||||||||||
Camilla Sylvest | 03/10/2022 - 03/10/2025 | 03/10/2022 | (2) | 31/12/2025 | 03/10/2023 - 03/10/2032 | 368.50 | 4,050 | — | — | 4,050 | — | — | 4,050 | — | ||||||||||||||
03/07/2023 - 03/07/2026 | 03/07/2023 | (2) | 31/12/2026 | 03/07/2024 - 03/07/2033 | 355.40 | 1,200 | — | — | — | — | 1,200 | 1,200 | 1,200 | |||||||||||||||
Total | 5,250 | — | — | 4,050 | — | 1,200 | 5,250 | 1,200 | ||||||||||||||||||||
112 | ||
Information regarding the reported financial year | ||||||||||||||||||||||||||||
Opening balance | During the Year | Closing balance | ||||||||||||||||||||||||||
Name of Directors | Performance period | Award date | Vesting date | End of retention period | Exercise period | Exercise price of stock option (€) | Stock options held at the beginning of the year | Stock options awarded | Stock options exercised | Stock options vested | Stock options subject to a service condition | Stock options awarded and unvested | Stock options held at the end of the year | Stock options subject to a retention period | ||||||||||||||
Peter Verhaeghe | 18/06/2016 - 18/06/2019 | 06/18/2016 | (1) | 31/12/2019 | 01/01/2020 - 18/06/2026 | 11.38 | 4,000 | — | 4,000 | — | — | — | — | — | ||||||||||||||
21/12/2018 - 21/12/2021 | 12/21/2018 | (1) | 31/12/2021 | 01/01/2022 - 21/12/2028 | 86.32 | 10,000 | — | — | — | — | — | 10,000 | — | |||||||||||||||
20/12/2019 - 20/12/2022 | 12/20/2019 | (1) | 31/12/2022 | 01/01/2023 - 20/12/2029 | 135.75 | 10,000 | — | — | — | — | — | 10,000 | — | |||||||||||||||
21/12/2020 - 21/12/2023 | 12/21/2020 | (1) | 31/12/2023 | 01/01/2024 - 21/12/2030 | 247.60 | 10,000 | — | — | — | — | — | 10,000 | — | |||||||||||||||
24/12/2021 - 24/12/2024 | 12/24/2021 | (2) | 31/12/2024 | 01/01/2025 - 24/12/2031 | 309.20 | 2,700 | — | — | — | — | — | 2,700 | — | |||||||||||||||
23/12/2022 - 23/12/2025 | 12/23/2022 | (2) | 31/12/2025 | 01/01/2026 - 23/12/2032 | 359.6 | 2,700 | — | — | 2,700 | — | — | 2,700 | — | |||||||||||||||
03/07/2023 - 03/07/2026 | 07/03/2023 | (2) | 31/12/2026 | 01/01/2027 - 03/07/2033 | 355.40 | 1,600 | — | — | — | — | 1,600 | 1,600 | 1,600 | |||||||||||||||
Total | 41,000 | — | 4,000 | 2,700 | — | 1,600 | 37,000 | 1,600 | ||||||||||||||||||||
1)1/3 of stock options vests on the first anniversary of the grant and the remaining 2/3rd vest in equal monthly installments (24 in total) over the next two years, each time upon the 1st day of the month.
2)Stock options vest upon third anniversary of the grant.
3)Donald deBethizy retired from the Board of Directors, the Remuneration and Nomination and Research and Development Committee on May 27, 2025.
113 | ||
C.BOARD PRACTICES
Director Independence
As a foreign private issuer, under the Nasdaq Listing Rules, we are not required to have a majority independent directors
on our Board of Directors, except that Audit and Compliance Committee is required to consist fully of independent
directors. However, our Board of Directors has determined that, taking into account any applicable committee
independence standards, at the date of this Annual Report, all of our Non-Executive Directors, including the members of
Audit and Compliance Committee, are “independent directors” under Rule 10A-3 of the Exchange Act and the
applicable rules of Nasdaq and of the DCGC. In making such determination, our Board of Directors considered the
relationships that each Non-Executive Director has with us and all other facts and circumstances our Board of Directors
deemed relevant in determining the director’s independence, including the number of ordinary shares beneficially owned
by the director and his or her affiliated entities (if any).
The DCGC requires that the composition of Non-Executive Directors is such that the members are able to operate
independently and critically vis-à-vis one another, the Executive Directors, and any particular interests involved. As of
the date of this Annual Report, all Non-Executive Directors meet the independence criteria contained in the DCGC.
Therefore, in the opinion of the Non-Executive Directors, the composition of our Non-Executive Directors complies
with the independence requirements of best practice provisions 2.1.7 to 2.1.9 of the DCGC. Our Board of Directors has
consequently also determined that all members of our committees are independent under the applicable rules of the
DCGC.
As of the date of this Annual Report (or in any period before), none of the members of our Board of Directors and Senior
Management Team has or has had a family relationship with any other member of our Board of Directors or Senior
Management Team.
Directors may be suspended or removed by the General Meeting at any time, with or without cause, by means of a
resolution passed by a simple majority of the votes cast. Pursuant to the DCC, Executive Directors may also be
suspended by the Board of Directors. The suspension of an Executive Director by the Board of Directors may be
discontinued by the General Meeting.
Diversity
In accordance with applicable Dutch legislation, we are required to report annually to the Social Economic Council
(Sociaal-Economische Raad) on (i) the gender ratio, i.e., the male and female Executive Directors and Non-Executive
Directors, as well as employees in managerial positions at the end of the financial year, (ii) the Company’s self-imposed
appropriate and ambitious targets in the form of a target figure to make the ratio between the number of male and female
Executive Directors and Non-Executive Directors, as well as in categories of employees in managerial positions to be
determined by the Company, more balanced, and (iii) the plan of action to achieve these targets or quotas. If we have not
complied with one or more of the foregoing, we are required to report on the reasons for this non-compliance.
In accordance with our Diversity, Equity and Inclusion Policy, we aim to foster an inclusive work environment in
support of our strategic plan and priorities. We continue to raise the bar in this regard, and to commit to measures and
goals designed to support our maturing company culture. We aim to have an equal gender balance in our Board of
Directors and in our Company leadership (including functional leaders and project leaders).
As of December 31, 2025, our Board of Directors consisted of 9 directors, including 1 Executive Director and 8 Non-
Executive Directors. Of the directors who chose to disclose their gender, the Board of Directors contained 5 male
directors and 3 female directors (Non-Executive Directors), translating into a 55.56% male/33.33% female balance for
our full Board of Directors (compared to 6 males and 3 females (Non-Executive Directors) (60.00%/30.00%) as of
December 31, 2024) and a 62.50% male / 37.50% female balance for our Non-Executive Directors (compared to 66.67%
male/33.33% female as of December 31, 2024). 90% of our directors in the Board of Directors are independent. In line
with our reporting to the Social Economic Council, our annual objective is to attain an equal gender balance (50% male
and 50% female) by 2050 in our Board of Directors and in our Company leadership (including functional and project
leaders).
In 2025, one Non-Executive Director (Anthony Rosenberg) was re-appointed. Although the gender balance was not
equal, our Board of Directors nominated Anthony Rosenberg for appointment at the 2025 General Meeting. Our Board
of Directors highly valued the skills, knowledge and expertise built up during his career and his contribution and
performance as Non-Executive Director. The Board of Directors will take the targets into account for future nomination
appointments.
As of December 31, 2025, our Company leadership team consisted of 78 persons, comprised of a mix of
39 males and 39 females, (50% / 50% respectively) while 0 positions remained vacant. Compared to
114 | ||
57 persons as of December 31, 2024, comprised of a mix of 24 males and 28 females, (42% / 49% respectively) while 5
positions remained vacant. Our leadership consists of all full time employees reporting directly to our CEO, as well as all
(other) leaders of our largest functions and projects. Each of these positions is characterized by a high impact across the
organization, leading a global and cross functional team and having a global reach. As of December 31, 2025, 61% of
our workforce were female and 39% were male (compared to 58% female and 42% male as of December 31, 2024).
Role of the Board in Risk Oversight
Our Board of Directors is responsible for the oversight of our risk management activities and has specifically designated
the audit and compliance committee (the Audit and Compliance Committee) to assist our Board of Directors in this task
and prepare recommendations in this respect to the Board of Directors. While our Board of Directors oversees our risk
management, our Senior Management Team is responsible for day-to-day risk management processes. Our Board of
Directors expects our Senior Management Team to consider risk and risk management in each business decision, to
proactively develop and monitor risk management strategies and processes for day-to-day activities and to effectively
implement risk management strategies adopted by the Board of Directors. We believe this division of responsibilities is
the most effective approach for addressing the risks we face.
Composition, Appointment and Dismissal
The Articles of Association provide that our Board of Directors will consist of our Executive Director(s) and Non-
Executive Directors. The number of Executive Directors must at all times be less than the number of Non-Executive
Directors. The number of directors, as well as the number of Executive Directors and Non-Executive Directors, is
determined by our Board of Directors, provided that the Board of Directors must consist of at least three members.
Our directors are appointed by the General Meeting for a period of four years as either Executive Directors or as Non-
Executive Directors. This four-year term aligns with best practice 2.2.1 of the DCGC, which stipulates that executive and
Non-Executive Directors may be appointed for a maximum period of four years. We believe that appointing directors for
a four-year term, rather than for example annual (re-)appointments, promotes stability and continuity within the Board of
Directors. It also allows deserving candidates to be appointed for more than one year, enhancing our position in
recruitment processes, as longer appointment periods are generally more attractive to candidates. Additionally, it
contributes to the Board of Directors' and, by extension, the Company's ability to focus on long-term goals, in line with
the DCGC's principle that a company's strategy should aim for sustainable long-term value creation.
In accordance with best practice provision 2.2.1 of the DCGC, Executive Directors may be reappointed for periods not
more than four years at a time. In accordance with best practice provision 2.2.2 of the DCGC, Non-Executive Directors
may be reappointed once for a period of four years, after which the Non-Executive Director may be reappointed again
for a period of two years, which reappointment may be extended by at most two years. In the event of a reappointment
after an eight-year period, reasons will be given in the report of the Board of Directors. The Board of Directors is
required to make one or more proposals for each seat on our Board of Directors to be filled. A resolution to nominate a
director by our Board of Directors (with support from the remuneration and nomination committee (the Remuneration
and Nomination Committee) may be adopted by a simple majority of the votes cast.
Our Board of Directors conducts evaluations of all its directors and director candidates to create a well-rounded board,
designed to promote long-term shareholder value creation through strong leadership and oversight. The Board of
Directors recognizes that directors who serve on the board for longer terms can be valuable sources of continuity,
understanding of the business and historical insight.
Our Board of Directors designates one Executive Director as CEO and may grant other titles to Executive Directors (if
appointed). Our Board of Directors also designates a Non-Executive Director as chairperson of the Board of Directors
and a Non-Executive Director as vice chairperson of the Board of Directors. The legal relationship between an executive
member of the Board of Directors and argenx SE will not be considered as an employment agreement. Employment
agreements between an Executive Director and a Group company (other than argenx SE) are permitted. In the absence of
an employment agreement, members of a board of directors generally do not enjoy the same protection as employees
under Dutch labor law.
For a discussion of date of expiration of the current term of office and the period during which the person has served in
that office, “Item 6.1. — Directors, Senior Management and Employees — Directors and Senior Management”.
Except for the arrangements described in “Item 7.B. — Related Party Transactions — Agreements with Our Senior
Management”, there are no arrangements or understanding between us and any of the Executive Directors providing for
benefits upon termination of their employment, other than as required by applicable law. In addition, the contracts
between us and our Non-Executive Directors do not provide for any benefits upon termination. In addition, the Company
is not party to any agreement with a director or employee providing compensation if his or her employment is terminated
because of a public takeover offer in respect of the Company.
115 | ||
Committees
In accordance with the DCGC, our Non-Executive Directors can set up specialized committees to analyze specific issues
and advise the Non-Executive Directors on those issues and prepare resolutions with respect thereto.
The committees are advisory bodies only, and the decision-making remains within the collegial responsibility of the
Board of Directors. The Non-Executive Directors determine the terms of reference of each committee with respect to the
organization, procedures, policies and activities of the committee.
Our Board of Directors has established and appointed (i) an Audit and Compliance Committee; and (ii) the
Remuneration and Nomination Committee.
The composition and function of these committees complies with all applicable requirements of Euronext Brussels, the
DCGC, the Exchange Act, the exchange on which the ordinary shares and the ADSs are listed and U.S. SEC rules and
regulations.
Only Non-Executive Directors qualify for membership of these committees. The Audit and Compliance Committee and
the Remuneration and Nomination Committee may not be chaired by the chairperson of the Board of Directors or by a
former Executive Director of the Company.
In addition to the aforementioned legally required subcommittees, our Board of Directors may also opt to incorporate
informal committees consisting of Non-Executive Directors and other internal and external persons in argenx, in order to
facilitate discussions and act as a sounding board on specific projects, as well as on a more permanent basis. Our Board
of Directors has incorporated a research and development committee and a commercialization committee.
Audit and Compliance Committee
Our Audit and Compliance Committee consists of four members: Steve Krognes (chairperson), Peter Verhaeghe,
Anthony Rosenberg and James Daly.
Our Board of Directors previously established that Peter Verhaeghe, Anthony Rosenberg, James Daly and Steve
Krognes satisfy the independence requirements set forth in Rule 10A-3 of the Exchange Act and that Steve Krognes
qualifies as “audit committee financial experts” as defined by SEC rules and Article 39 paragraph 1 of Directive
2014/56/EU of the European Parliament and of the Council of April 16, 2014 amending Directive 2006/43/EC on
statutory audits of annual accounts and consolidated accounts (which has been laid down in Dutch law by the Decree
establishment audit committee (Besluit instelling auditcommissie) and has the requisite financial sophistication under the
applicable Nasdaq rules and regulations. Further, our Board of Directors established that the composition of the Audit
and Compliance Committee meets the requirements under the Dutch Decree on Establishing Audit Committees.
Our Audit and Compliance Committee assists our Board of Directors in overseeing the accuracy and integrity of our
accounting, financial and non-financial (including sustainability) reporting processes and audits and reviews of our
(consolidated) financial statements as well as non-financial information, the implementation and effectiveness of an
internal control system and our compliance with legal and regulatory requirements, the independent auditors’
qualifications and independence and the performance of the independent auditors. Our Audit and Compliance Committee
is also responsible for monitoring the status of, and compliance with, our global ethics and compliance program and
meets with the head of our ethics and compliance function at least quarterly to discuss the status and overall
effectiveness of the program as well as any issues or incidents that occurred and remedial actions needed (if applicable).
The Committee furthermore oversees climate-related risks and supervises the status of the Company’s cybersecurity
program and regularly (at least quarterly) discusses the status thereof with management.
Our Audit and Compliance Committee is governed by a charter that complies with the Nasdaq Listing Rules and the
DCGC and is publicly available on our website. It is responsible for, among other things, establishing methods and
procedures for supervising, and where necessary requiring improvements of, our financial reporting, risk management,
ethics and compliance and organization for the purpose of making appropriate recommendations to our Board of
Directors in that regard.
Our Audit and Compliance Committee meets as often as is required for its proper functioning, but at least four times a
year and at least once a year meets separately with our independent auditor.
Our Audit and Compliance Committee reports regularly to our Board of Directors on the exercise of its functions. It
informs our Board of Directors about all areas in which action or improvement is necessary in its opinion and produces
recommendations concerning the necessary steps or resolutions that need to be taken. The audit review and the reporting
on that review cover us and our subsidiaries as a whole. The members of the Audit and Compliance Committee are
entitled to receive all information which they need for the performance of their function, from our Board of Directors
116 | ||
and employees. Every member of the Audit and Compliance Committee shall exercise this right in consultation with the
chairperson of the Audit and Compliance Committee. Please refer to “Item 6.C — Board Practices — Report Audit and
Compliance Committee” for an overview of the number of meetings and attendance rates.
Report Audit and Compliance Committee
The Audit and Compliance Committee reports regularly to our Board of Directors on the exercise of its functions. It
informs our Board of Directors about all areas in which action or improvement is necessary in its opinion and produces
recommendations concerning the necessary steps that need to be taken. The audit review and the reporting on that review
cover the Company and its subsidiaries as a whole and the external auditor is also present during these meetings.
In 2025, the main topics of discussion at the meetings were the 2024 consolidated financial statements and press release
as well as interim consolidated financial statements and press releases, internal audit and external auditors’ reports, the
review of quarterly forecasts and financial plan, tax updates, cash management, compliance with CSRD and updating the
double materiality assessment), the Company’s ethics and compliance program, the Company’s cyber security program
and risks related to AI, the Company’s privacy program and the certification of the recently included VOR (Verklaring
Omtrent Risicobeheersing/statement on risk management) statement in the DCGC.
In 2025, 8 formal Audit and Compliance Committee meetings were held as well as multiple informal meetings. The
formal meeting attendance rate for our Non-Executive Directors is set out in the table below.
Name | Number of meetings attended in 2025 since appointment | Attendance % | ||
Steve Krognes (chairperson) | 8 | 100% | ||
Peter Verhaeghe | 7 | 87.5% | ||
Anthony Rosenberg | 8 | 100% | ||
James Daly | 7 | 87.5% |
Remuneration and Nomination Committee
We have established a Remuneration and Nomination Committee, which serves as both the remuneration committee and
selection and appointment committee as prescribed by the DCGC. Our Remuneration and Nomination Committee
currently consists of three members: Ana Céspedes (chairperson), Peter Verhaeghe and Steve Krognes. Donald
deBethizy retired from the Board of Directors and the Remuneration and Nomination Committee on May 27, 2025.
Consequently, Ana Céspedes succeeded Donald deBethizy as the chairperson of the Remuneration and Nomination
Committee and Steve Krognes became a member of the Remuneration and Nomination Committee.
Our Remuneration and Nomination Committee is responsible for, among other things:
•regularly reviewing the remuneration policy and practices in light of all relevant circumstances and benchmarks, and
recommending to the Non-Executive Directors the remuneration of the individual Executive Directors;
•advising our Board of Directors in respect of the remuneration for the Non-Executive Directors;
•preparing the remuneration report to be included in our annual report; and
•drawing up selection criteria and appointment procedures for directors and making proposals for appointment and re-
appointment of the directors.
The Remuneration and Nomination Committee consists of at least three members. The Remuneration and Nomination
Committee meets as often as is required for its proper functioning, but at least once per year to evaluate its functioning.
Please refer to “Item 6.C — Board Practices — Report Remuneration and Nomination Committee” for an overview of
the number of meetings and attendance rates.
Report Remuneration and Nomination Committee
The Remuneration and Nomination Committee assists the Board of Directors by, amongst other matters, regularly
reviewing our remuneration policy, preparing remuneration proposals and periodically assessing the size and
composition of the Board of Directors and the Executive Management Team and development of talent throughout the
Company. During their deliberations in 2025, the main topics of discussion at the meetings were long-term succession
and development planning for key Company leadership and proposing appropriate remuneration policies during the
117 | ||
annual general meeting (AGM) held on May 27, 2025 (the 2025 General Meeting) and the EGM, taking into account
stakeholder feedback following extensive engagement efforts and benchmarking all remuneration against our peer group.
In 2025, 6 formal Remuneration and Nomination Committee meetings were held as well as multiple informal meetings.
The formal meeting attendance rate for our Directors is set out in the table below.
Name | Number of meetings attended in 2025 since appointment (and up to resignation or since joining, as applicable) | Attendance % | ||
Ana Céspedes1) | 6 | 100% | ||
Donald deBethizy2) (chairperson until May 27, 2025) | 3 | 100% | ||
Peter Verhaeghe | 6 | 100% | ||
Steve Krognes3) | 3 | 100% |
1)Ana Céspedes succeeded Donald deBethizy as chairperson of the Remuneration and Nomination Committee effective May 27, 2025.
2)Donald deBethizy retired from the Board of Directors and the Remuneration and Nomination Committee on May 27, 2025.
3)Steve Krognes joined the Remuneration and Nomination Committee effective May 27, 2025.
Informal subcommittees
Research and Development Committee
The research and development committee consists of members of our Board of Directors and other persons, which
composition may vary from time to time. Currently, the research and development committee consists of three members
who are also members of our Board of Directors: Brian Kotzin(chairperson), Pamela Klein and Tim Van
Hauwermeiren. Non-board member advisors of the research and development committee include David Lacey, Prof.
Hans de Haard, Wim Parys and Mary Lynne Hedley. Ad-hoc participants to the committee meetings include a variety of
employees and/or external advisors, depending on the needs of the committee and the topics under discussion. Donald
deBethizy retired from the Board of Directors and the Research and Development Committee on May 27, 2025.
The research and development committee is responsible for, among other things:
•monitoring and overseeing our research and development goals, strategies and measures;
•serving as a sounding board to our research and development management, general management and Board of
Directors; and
•performing strategic reviews of our key research and development programs. The research and development
committee also promotes transparency in R&D practices, ensuring that findings, both positive and negative, are
reported accurately and openly, and reviews, comments on and makes recommendations in respect of our non-
financial reporting on R&D related topics to the Audit and Compliance Committee and/or the Board of Directors.
All members of the research and development committee shall have adequate industrial, academic and/or practical
experience with the research and development of biopharmaceuticals.
Our research and development committee meets as often as is required for its proper functioning, but typically meets at
least once prior to each meeting of our Board of Directors and reports regularly to our Board of Directors on the outcome
of its deliberations, including any recommendations to the Board of Directors or the Senior Management Team. The
chairperson of our research and development committee reports to our Board of Directors on the research and
development committee’s discussions and strategic advice after each meeting on all matters within its duties and
responsibilities. Please refer to “Item 6.C — Board Practices — Report Research and Development Committee” for an
overview of the number of meetings and attendance rates.
Report Research and Development Committee
The research and development committee functions as a sounding board to our research and development management,
the Executive Management Team and the Board of Directors, and monitors our research and development goals,
strategies and measures. In 2025, the committee held 5 formal meetings, in which it focused mainly on the vision and
strategy on science, the Company’s research and development pipeline including its preclinical and clinical stage
118 | ||
product-candidates, potential future indications for its commercial stage products and developments in relation to our
IIP.
The meeting attendance rate for our directors is set out in the table below.
Name | Number of meetings attended in 2025 since appointment (and up to resignation or since joining, as applicable) | Attendance % | ||
Brian Kotzin (chairperson) | 5 | 100% | ||
Donald deBethizy1) | 2 | 100% | ||
Pamela Klein | 5 | 100% | ||
Tim Van Hauwermeiren2) | 5 | 100% |
1)Donald deBethizy retired from the Board of Directors and the Research and Development Committee on May 27, 2025.
2)Tim Van Hauwermeiren joined the Research and Development Committee as a member as on May 27, 2025.
Commercialization Committee
Our commercialization committee consists of members of our Board of Directors and other persons, which composition
may vary from time to time. As of the date of this Annual Report, the commercialization committee consists of three
members:James Daly (chairperson), Anthony Rosenberg and Camilla Sylvest.
The commercialization committee is responsible for, among other things:
•reviewing and guiding the commercialization strategies and to promote and support innovation within
commercialization efforts;
•providing guidance on the global product launch strategies, global manufacturing, packaging, labeling and
distribution strategies, patient support programs and end-of-life product management;
•sales and marketing activities, including engagement of downstreams payors and stakeholders.
Our commercialization committee meets as often as is required for its proper functioning and in practice meets at least
once per quarter. The commercialization committee reports regularly to our Board of Directors on the outcome of its
strategic reviews and any recommendations to the Board of Directors or Senior Management Team.
Please refer to “Item 6.C — Board practices — Report Commercialization Committee” for an overview of the number of
meetings and attendance rates.
Report Commercialization Committee
The commercialization committee functions as a sounding board on branded and unbranded strategic marketing plans for
the Board of Directors. In 2025, the committee held 5 formal meetings, in which it focused mainly on the continued
commercialization efforts of VYVGART in gMG and CIDP, the execution of our launch of the PFS in the U.S. as well
as the preparation for potential future launches, subject to obtaining further approvals.
The meeting attendance rate for our directors is set out in the table below.
Name | Number of meetings attended in 2025 since appointment | Attendance % | ||
James Daly (chairperson) | 5 | 100% | ||
Anthony Rosenberg | 5 | 100% | ||
Camilla Sylvest | 5 | 100% |
Corporate Governance Practices
Our Board By-Laws describe, inter alia, the procedure for holding meetings of the Board of Directors, for the decision-
making by the Board of Directors and the Board of Directors’ operating procedures.
119 | ||
In accordance with our Articles of Association, our Board of Directors meets at least once every three months to discuss
the state of affairs within the Company and the expected developments.
Under our Board By-Laws, the members of our Board of Directors must endeavor, insofar as is possible, to ensure that
resolutions are adopted unanimously. Where unanimity cannot be achieved and Dutch law, the Articles of Association or
the Board By-Laws do not prescribe a larger majority, all resolutions of our Board of Directors must be adopted by a
simple majority of the votes cast in a meeting at which at least a majority of the members of our Board of Directors then
in office are present or represented. The Articles of Association provide that in case of a tie of votes, the chairperson
does not have a casting vote and as such the proposal will be rejected in case of a tie.
Under the Board By-Laws, some specific matters require approval of the majority of the Non-Executive Directors. These
matters are set out in Schedule 1 of our Board By-Laws. Our Board By-Laws are available on our website. The Non-
Executive Directors may also determine that certain other matters shall require approval of a certain majority of the Non-
Executive Directors. Such matters shall be clearly specified and notified to the Executive Director(s) in writing.
Resolutions of the Board of Directors may also be adopted outside of a meeting in writing, provided that all directors in
office (in respect of whom no conflict of interest exists as referred to in the Articles of Association) have consented in
writing to this manner of decision-making. A director may issue a proxy for a specific Board of Directors meeting to
another director in writing.
A director having a direct or indirect personal interest that conflicts with the interest of the Company and its affiliated
enterprise has a conflict of interest. Each director shall inform all other directors of a conflict of interest without delay. A
director shall not participate in the deliberations and decision-making process in relation to an item if he has a conflict of
interest with respect thereto. In such case, the other directors shall resolve the item. In case because of this no resolution
can be adopted by the Executive Director(s), the Non-Executive Directors will resolve on the matter. In case because of
this no resolution can be adopted by the Non-Executive Directors, the Board of Directors will resolve on the matter as if
there were no conflict of interest.
The Executive Director(s) are required to be asked their vision on their own remuneration in accordance with best
practice provision 3.2.2 of the DCGC but may not participate in the adoption of resolutions (including any deliberations
in respect of such resolutions) relating to their remuneration.
Board Evaluation
The Board of Directors evaluates its functioning and the functioning of its committees and of each individual director
annually. The evaluation process is performed with the help of an external professional board evaluation consultant. In
2025, the evaluation was performed by Nasdaq Center for Board Excellence. The evaluation includes preparing specific
questionnaires focusing on the skills and competences most relevant to us, and the most material board topics and
challenges we face. The written questionnaire is then followed up by one-to-one interviews with the representative of
Nasdaq Center for Board Excellence with each member of the Board of Directors, followed by a debrief and discussion
held with the external evaluator and the entire Board of Directors both in writing (in form of a report) and in the form of
a live discussion of the evaluation report aimed at distilling specific learnings and conclusions.
Based on the self-evaluation performed, the Non-Executive Directors concluded that the Board of Directors and its
committees had properly discharged their responsibilities during 2025. The Board of Directors identified certain
strengths and weaknesses and adopted a plan for further board development and succession in 2026. All directors
consider the Board of Directors, in line with previous years to have high integrity with a continued commitment to high
quality governance and a shared desire to continuously improve the Board of Directors. The importance to preserve this
was highlighted by Nasdaq Center for Board Excellence. All Non-Executive Directors consider fostering further
development and education of great importance, which can be developed in 2026 through advisory board sessions, deep-
dives and other external educational courses. Lastly, all Non-Executive Directors will continue discussions on Board of
Directors and the Executive Management team succession and focus on further developing profiles for future Board of
Director candidates.
120
D.EMPLOYEES
As of December 31, 2025, we had 1,863 employees and 1,659 consultants, which we refer to as “contingent workers”.
At each date shown below, we had the following number of employees, broken out by department and geography.
As of December 31, | ||||||
2025 | 2024 | 2023 | ||||
Function: | ||||||
Research and development | 773 | 644 | 653 | |||
Selling, general and administrative | 1,090 | 955 | 495 | |||
Total | 1,863 | 1,599 | 1,148 | |||
Geography: | ||||||
U.S. | 789 | 694 | 454 | |||
Belgium | 565 | 466 | 355 | |||
Japan | 146 | 139 | 116 | |||
Switzerland | 71 | 49 | 28 | |||
Germany | 55 | 41 | 25 | |||
UK | 48 | 44 | 37 | |||
Italy | 39 | 33 | 27 | |||
France | 38 | 38 | 40 | |||
The Netherlands | 38 | 34 | 22 | |||
Spain | 34 | 32 | 20 | |||
Canada | 24 | 19 | 16 | |||
Rest of the World/Remote | 16 | 10 | 8 | |||
Total | 1,863 | 1,599 | 1,148 | |||
Collective bargaining agreements (CBAs) can be entered into in Belgium and other jurisdictions at the national, industry,
or company levels. These CBAs are binding on both employers and employees. We have no trade union representation
or CBAs at the company level, but we are subject to the national and chemical industry CBAs. The CBAs currently
applicable to us relate to employment conditions such as wages, working time, job security, innovation and
supplementary pensions. We have not had, and do not anticipate having, disputes on any of these subjects. CBAs may,
however, change the employment conditions of our employees in the future and hence adversely affect our employment
relationships.
E.SHARE OWNERSHIP
For information regarding the share ownership of our directors and members of our executive committee, see “Item 6.B.
F.DISCLOSURE OF A REGISTRANT’S ACTION TO RECOVER ERRONEOUSLY AWARDED
COMPENSATION
Not applicable.
ITEM 7.MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A.MAJOR SHAREHOLDERS
The following table sets forth information with respect to the beneficial ownership of our ordinary shares as at February
19, 2026 for:
•each person who is known by us to own beneficially more than 3% of our total outstanding ordinary shares;
•each member of our Board of Directors and our Senior Management Team; and
121 | ||
•all members of our Board of Directors and our Senior Management Team as a group.
Beneficial ownership is determined in accordance with the rules of the SEC, which may materially differ from other
rules applicable to us. The SEC rules generally attribute beneficial ownership of securities to persons who possess sole
or shared voting power or investment power with respect to those securities and include ordinary shares that can be
acquired within 60 days of February 19, 2026. The percentage ownership information shown in the table is based upon
62,062,888 ordinary shares outstanding as at February 19, 2026.
Except as otherwise indicated, all of the shares reflected in the table are ordinary shares and all persons listed below have
sole voting and investment power with respect to the shares beneficially owned by them, subject to applicable
community property laws. The information is not necessarily indicative of beneficial ownership for any other purpose.
In computing the number of ordinary shares beneficially owned by a person and the percentage ownership of that person,
we deemed outstanding ordinary shares subject to options held by that person that are immediately exercisable or
exercisable within 60 days of February 19, 2026. We did not deem these shares outstanding, however, for the purpose of
computing the percentage ownership of any other person. The information in the table below is based on information
known to us or ascertained by us from public filings made by the shareholders.
Shares beneficially owned | ||||
Name of beneficial owner | Number | Percentage | ||
3% or Greater Shareholders: | ||||
FMR LLC (1) | 6,152,483.21 | 9.99% | ||
6,019,642.92 | 9.78 (voting) % | |||
Blackrock, Inc. (2) | 3,874,991 | 6.33% | ||
4,521,917 | 7.39 (voting) % | |||
T. Rowe Price Group, Inc. (3) | 3,647,000 | 6.00% | ||
Wellington Management Group LLP (4) | – | 0.00% | ||
2,150,704 (voting) | 3.62 (voting) % | |||
Capital Research and Management Company (5) | — | 0.00% | ||
1,837,683 (voting) | 3.07 (voting) % | |||
Janus Henderson Group plc (6) | 1,784,723 | 3.02% | ||
Directors and Senior Management | ||||
Tim Van Hauwermeiren (7) | * % | |||
Donald deBethizy (8) | * % | |||
Steve Krognes (9) | * % | |||
Peter Verhaeghe (10) | * % | |||
Pamela Klein (11) | * % | |||
Anthony Rosenberg (12) | * % | |||
James Daly (13) | * % | |||
Camilla Sylvest (14) | * % | |||
Ana Céspedes (15) | * % | |||
Brian Kotzin (16) | * % | |||
Karen Massey (17) | * % | |||
Karl Gubitz (18) | * % | |||
Luc Truyen (19) | * % | |||
Peter Ulrichts (20) | * % | |||
Arjen Lemmen (21) | * % | |||
Malini Moorthy (22) | * % | |||
Andria Wilk (23) | * % | |||
All executive officers and directors as a group (17 persons) | 1.17% | |||
•Indicates beneficial ownership of less than 1% of the total outstanding ordinary shares.
1)Based solely on the most recent transparency notification filed with Dutch the Authority for the Financial Markets (Stichting Autoriteit
Financiële Markten) (AFM) as of February 19, 2026. Consists of (a) 6,152,483.21 ordinary shares, and (b) voting rights on 6,019,642.92 ordinary
shares. Other information regarding this shareholder’s beneficial ownership of our shares is not known to us or, to our knowledge, ascertainable
from public filings.
2)Based solely on the most recent transparency notification filed with Dutch the Authority for the Financial Markets (Stichting Autoriteit
122 | ||
Financiële Markten) (AFM) as of February 19, 2026. Consists of (a) 3,253,767 ordinary shares, 25,008 contracts for difference, and 596,216
stock certificates (certificaat van aandeel) and (b) voting rights on (i) 3,822,260 ordinary shares, (ii) 25,008 contracts for difference, and 674,649
stock certificates (certificaat van aandeel). Other information regarding this shareholder’s beneficial ownership of our shares is not known to us
or, to our knowledge, ascertainable from public filings.
(1.Based on the most recently available Schedule 13G filed with the SEC on November 14, 2025. According to its Schedule 13G, T. Rowe Price
Associates, Inc. reported having sole voting power over 3,590,111 ADSs and sole dispositive power over 3,640,675 ADSs. The Schedule 13G
contained information as of September 30, 2025 and may not reflect current holdings of the Company’s stock. The address for T. Rowe Price
Associates, Inc. is 100 E. Pratt Street, Baltimore, MD 21202.
(2.Based solely on the most recent transparency notification filed with the AFM as of February 19, 2026. Consists of voting rights on 330,691
ADSs, 1,819,494 ordinary shares, and 519 total equity return swaps. Other information regarding this shareholder’s beneficial ownership of our
shares is not known to us or, to our knowledge, ascertainable from public filings.
(3.Based solely on the most recent transparency notification filed with the AFM as of February 19, 2026. Consists of voting rights on 206,694
ordinary shares and 1,630,989 ADSs. Other information regarding this shareholder’s beneficial ownership of our shares is not known to us or, to
our knowledge, ascertainable from public filings.
(4.Based solely on the most recent transparency notification filed with the AFM as of February 19, 2026. Consists of 10,882 ordinary shares and
1,773,841 ADSs. Other information regarding this shareholder’s beneficial ownership of our shares is not known to us or, to our knowledge,
ascertainable from public filings.
(5.Consists of (1) 96,975 ordinary shares (of which 72,095.61 ordinary shares are directly and indirectly held by Mr. Van Hauwermeiren and
24,897.39 ordinary shares are indirectly held by three of Mr. Van Hauwermeiren’s direct family members (being (i) his partner, Ms Vissers; (ii)
his daughter, Ms. F. Van Hauwermeiren; and (iii) his daughter, Ms. T. Van Hauwermeiren, who each hold the interest in these ordinary shares
through an entity, Stichting Administratiekantoor Cinclus, which entity in turn holds the interest in these ordinary shares through the Belgian civil
company (société civile/burgerlijke maatschap), and (2) 233,670 shares issuable upon the exercise of stock options that are immediately
exercisable or exercisable within 60 days of February 19, 2026.
(6.Consists of 2,465 ordinary shares and 44,330 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(7.Consists of 262 ordinary shares, 2,400 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable within
60 days of February 19, 2026 and 1,197 shares issuable upon the settlement of restricted stock units vesting within 60 days of February 19, 2026.
(8.Consists of 2,290 ordinary shares and 35,400 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(9.Consists of 2,290 ordinary shares and 17,900 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(10.Consists of 2,290 ordinary shares and 27,880 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(11.Consists of 1,365 ordinary shares.
(12.Consists of 1,871 ordinary shares and 4,050 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(13.Consists of 1,401 ordinary shares and 4,050 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(14.Consists of 990 ordinary shares.
(15.Consists of 4,392 ordinary shares and 16,409 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(16.Consists of 4,871 ordinary shares and 37,534 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(17.Consists of 2,241 ordinary shares and 37,534 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(18.Consists of 2,545 ordinary shares and 39,655 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(19.Consists of 4,221 ordinary shares and 68,534 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
(20.Consists of 1,861 ordinary shares, 11,676 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026 and 1,350 shares issuable upon the settlement of restricted stock units vesting within 60 days of February 19,
2026.
(21.Consists of 1,035 ordinary shares and 14,971 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable
within 60 days of February 19, 2026.
Each of our shareholders is entitled to one vote per ordinary share. None of the holders of our shares have different
voting rights from other holders of shares.
As of the date of this Annual Report, we are not directly or indirectly owned or controlled by any shareholder, whether
individually or acting in concert. We are not aware of any arrangement that may, at a subsequent date, result in a change
of control of the Company.
The number of record holders in the U.S. is not representative of the number of beneficial holders nor is it representative
of where such beneficial holders are resident since many of these ordinary shares were held by brokers or other
nominees. As of February 19, 2026, assuming that all of our ordinary shares represented by ADSs are held by residents
of the U.S., we estimate that approximately 45.38% of our outstanding ordinary shares were held in the U.S. by
approximately one institutional holder of record.
To our knowledge, and other than changes in percentage ownership as a result of the shares issued in connection with
our initial and follow-on U.S. public offerings or publicly disclosed in AFM filings and any amendments thereof,there
has been no significant change in the percentage ownership held by the major shareholders listed above.
123
B.RELATED PARTY TRANSACTIONS
Agreements with Our Senior Management Team
There are no arrangements or understandings in place with major shareholders, customers, suppliers or others pursuant to
which any member of our Board of Directors or Senior Management Team has been appointed.
Other than as set forth in this Annual Report, there are no arrangements or understandings in place with major
shareholders, customers, suppliers or others pursuant to which any member of our Board of Directors or Senior
Management Team has been appointed.
We have entered into a management agreement with Tim Van Hauwermeiren as our CEO, our sole Executive Director.
The key terms of his agreement are as follows:
Tim Van Hauwermeiren | |
Base Pay | $827,160 |
Cash bonus | Maximum 60% of the base pay based on previously determined bonus targets established by the Non-Executive Directors |
Pension contributions1) | $44,168 |
Duration | Indefinite |
1)Amounts shown represent pension contributions paid during the year ended December 31, 2025.
As announced on January 5, 2026, there will be a leadership transition in May 2026. Peter Verhaeghe will step down as
Non-Executive Director and chairperson of the Board of Directors at the 2026 General Meeting. Tim Van Hauwermeiren
will step down from his current CEO role and it is envisaged that he will be appointed as a Non-Executive Director at the
2026 General Meeting and subsequently elected as by the Board of Directors as the chairperson of the Board of
Directors. Tim van Hauwermeiren’s management agreement will therefore be terminated.
It is also envisaged that Karen Massey, our current COO, will be appointed as an Executive Director at the 2026 General
Meeting and subsequently elected as CEO by the Board of Directors.
Karen Massey currently holds the role of COO and has an employment contract with our subsidiary, argenx Switzerland
SA, for an indefinite term. The 2026 annual report will reflect the main terms of her agreements with the Company and/
or its subsidiaries.
Karl Gubitz, our chief financial officer, has an employment contract with our subsidiary, argenx US Inc., for an
indefinite term.
Peter Ulrichts, our chief scientific officer has an employment contract with our subsidiary, argenx B.V., for an indefinite
term.
Arjen Lemmen, our vice president corporate development and strategy, has an employment contract with our subsidiary,
argenx B.V., for an indefinite term.
Andria Wilk, our global head of quality, has an employment contract with our subsidiary, argenx B.V., for an indefinite
term.
Malini Moorthy, our general counsel and corporate secretary has an employment contract with our subsidiary, argenx
US, for an indefinite term. Ms. Moorthy has also entered into a secondment agreement with argenx US, under which Ms.
Moorthy was seconded from argenx US to argenx B.V. and was based in Belgium for the period of April 1, 2023
through December 31, 2024. This secondment was extended through December 31, 2026.
Luc Truyen, our head of research and development management operations and our chief medical officer, has an
employment contract with our subsidiary, argenx US Inc. for an indefinite term. Mr. Truyen entered into a secondment
agreement with argenx US Inc., under which Mr. Truyen has been seconded from argenx US Inc. to argenx B.V. and is
based in Belgium for the period of April 1, 2022 through November 30, 2026 (unless otherwise extended by the parties).
Indemnification Agreements
In connection with our initial U.S. public offering, we entered into indemnification agreements with each of our Non-
Executive Directors and each member of our Senior Management Team. We have entered into such agreements with
124 | ||
each new non-executive director or member of our senior management when they have joined us since our initial U.S.
public offering. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to non-
executive directors, officers or persons controlling us pursuant to the foregoing provisions, we have been informed that,
in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore
unenforceable.
Transactions with Related Companies
From time to time, in the ordinary course of our business, we may contract for services from companies in which certain
of the members of our senior management or directors may serve as director or advisor. The costs of these services are
negotiated on an arm’s length basis and none of these arrangements are material to us. See also “Note 25 Related Party
Transactions” in our consolidated financial statements which are included to our Annual Report for the period ended
December 31, 2025.
Related Party Transactions Policy
In connection with our initial U.S. public offering, we entered into a related party transaction policy. Our Code of
Business Conduct and Ethics (Code of Conduct) and our Board Rules also include specific rules of transactions with
related parties.
C.INTERESTS OF EXPERTS AND COUNSEL
Not applicable.
ITEM 8.FINANCIAL INFORMATION
A.CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION
Consolidated financial statements
Our consolidated financial statements, which were prepared in accordance with IFRS, as issued by the IASB, are
included at the end of this Annual Report, starting at page F-1.
Legal proceedings
From time to time we may become involved in legal, governmental or arbitration proceedings or be subject to claims
arising in the ordinary course of our business. Regardless of the outcome, litigation can have an adverse impact on us
because of defense and settlement costs, diversion of management resources and other factors. During the previous 12
months, there have not been any legal, governmental or arbitration proceedings (including any such proceedings which
are pending or threatened of which we are aware) which may have, or have had in the recent past, significant effects on
argenx and/or the Group’s financial position or profitability.
Dividend Distribution Policy
Our Board of Directors has declared a series of interim distributions on account of the Company’s freely distributable
reserves for such amounts as was required to pay up the aggregate nominal value of all such shares that were issued to
holders of vested RSUs, all in accordance with our Equity Incentive Plan. In accordance with Dutch law, our Board of
Directors prepared and filed an interim simplified balance sheet demonstrating that there were sufficient freely
distributable reserves for such interim distributions. Such interim simplified balance sheet was filed with the Dutch trade
register. The aggregate amount of these interim distributions amounted to approximately €13,584 ($15,961) in 2025.
Other than these interim distributions, we have not paid or declared any cash dividends on our ordinary shares, and we
do not anticipate paying any cash dividends in the foreseeable future. All of our outstanding shares have the same
dividend rights. We intend to retain all available funds and any future earnings to fund the development and expansion of
our business.
Even if future operations lead to significant levels of distributable profits, we currently intend that any earnings will be
reinvested in our business and that cash dividends will not be paid until we have an established revenue stream to
support continuing cash dividends. In addition, payment of any future dividends to shareholders would be subject to
shareholder approval at a General Meeting, upon proposal of our Board of Directors, which proposal would be subject to
the approval of the majority of the Non-Executive Directors after taking into account various factors including our
business prospects, cash requirements, financial performance and new product development.
125 | ||
Our Articles of Association, as available on our website, contain the provision on the distribution of profits in article 20
(profits, distributions and losses).
B.SIGNIFICANT CHANGES
For details regarding events subsequent to the reporting period, please see “Note 30 — Events After the Balance Sheet
Date” in our consolidated financial statements, which are included to our Annual Report for the period ended
December 31, 2025.
ITEM 9.THE OFFER AND LISTING
A.OFFER AND LISTING DETAILS
B.PLAN OF DISTRIBUTION
Not applicable.
C.MARKETS
The ADSs have been listed on Nasdaq under the symbol “ARGX” since May 18, 2017, and our ordinary shares have
been listed on Euronext Brussels under the symbol “ARGX” since July 2014.
D.SELLING SHAREHOLDERS
Not applicable.
E.DILUTION
Not applicable.
F.EXPENSES OF THE ISSUE
Not applicable.
ITEM 10.ADDITIONAL INFORMATION
A.SHARE CAPITAL
Not applicable.
B.MEMORANDUM AND ARTICLES OF ASSOCIATION
Corporate Objectives
Directors
Conflict of Interest
Remuneration
126
Borrowing Powers
Rights, Preferences and Restrictions of Shares
Dividends and Other Distributions
Voting rights
Please see “Exhibit 2.3—Shareholders’ Meetings and Consents—Quorum and Voting Requirements” and “Exhibit 2.3 —
Comparison of Dutch Corporate Law, our Articles of Association and Board of Directors By-Laws and DGCL — Voting
Rights to Share in Company Profits
Please see “Exhibit 2.3 — Dividends and Other Distributions — Rights to Share in Company Profits”, incorporated
herein by reference.
Right to Surplus In the Event of Liquidation
Please see “Exhibit 2.3 — Dividends and Other Distributions — Right to Surplus In the Event of Liquidation”,
incorporated herein by reference.
Redemption Provisions
Please see “Exhibit 2.3 — Dividends and Other Distributions — Redemption Provisions”, incorporated herein by
reference.
Amendment of Articles of Association
Please see “Exhibit 2.3 — Articles of Association and Dutch Law — Dividends and Other Distributions — Redemption
Provisions”, incorporated herein by reference.
Shareholders’ Meetings and Consents
General Meeting, Voting Rights and Admission
General Meetings are held at the place where the Company has its official seat (being Amsterdam) or at Schiphol Airport
(municipality of Haarlemmermeer), the Netherlands. The Articles of Association provide that at least one annual General
Meeting shall be held within six months after the close of each fiscal year. Additional extraordinary General Meetings
may be held whenever our Board of Directors deems such to be necessary. Shareholders representing alone or in
aggregate at least one-tenth of our issued and outstanding share capital may, pursuant to the DCC, request that a General
Meeting be convened. If our Board of Directors has not taken the steps necessary to ensure that a General Meeting will
be held within the relevant statutory period after the request, the requesting persons may, at his/her/their request, be
authorized by a court in preliminary relief proceedings to convene a General Meeting.
We will give notice of any General Meeting by publication on our website and furthermore, to the extent required, in
another manner in accordance with the applicable stock exchange regulations. The notice convening any General
Meeting must include, among other items, an agenda indicating the place and date of the meeting, the items for
discussion and voting, the proceedings for registration including the registration date, as well as any proposals for the
agenda made by the Board of Directors or shareholders holding at least 3% of the issued share capital. For an annual
General Meeting, the agenda shall include, among other things, the adoption of the annual accounts, appropriation of our
profits and proposals relating to the composition of our Board of Directors.
Pursuant to Dutch law, shareholders holding at least 3% of our issued and outstanding share capital have a right to
request our Board of Directors to include items on the agenda of any General Meeting. Our Board of Directors must
127 | ||
agree to these requests, provided that (i) the request was made in writing and motivated, and (ii) the request was received
by the chairperson of our Board of Directors at least 60 days prior to the date of a General Meeting.
No resolutions shall be adopted on items other than those which have been included in the agenda. In accordance with
the DCGC, a shareholder may include an item on the agenda only after consulting our Board of Directors in that respect.
If one or more shareholders intends to request that an item be put on the agenda that may result in a change in the
Company’s strategy, our Board of Directors may invoke a response time of a maximum of 180 days until the day of a
General Meeting. In addition, pursuant to the DCC, our Board of Directors may invoke a statutory cooling-off period up
to a maximum of 250 days (wettelijke bedenktijd). For the Company, this will apply in case:
•shareholders request our Board of Directors to have a General Meeting consider a proposal for the appointment,
suspension or dismissal of one or more directors, or a proposal for the amendment of one or more provisions in the
Articles of Association relating thereto; or
•a public offering of shares in the capital of the Company is announced or made without the bidder and the Company
having been reached agreement about the offering; and
•only if our Board of Directors also considers the relevant situation to be substantially contrary to the interests of the
Company and its affiliated enterprises.
If our Board of Directors invokes such a cooling-off period, this causes the powers of the General Meeting to appoint,
suspend or dismiss directors (and to amend the Articles of Association in this respect) to be suspended.
General Meetings are presided over by the chairperson of the Board of Directors or, if he/she is absent, by the vice
chairperson of the Board of Directors. If both the chairperson and the vice chairperson are absent, the Non-Executive
Directors present at the General Meeting shall appoint one of them to be chairperson. In General Meetings, members of
the Board of Directors have an advisory vote. The chairperson of the General Meeting may decide at his/her discretion to
admit other persons to the General Meeting.
The external auditor of the Company shall attend a General Meeting in which the annual accounts are discussed.
Our Board of Directors must give notice of a General Meeting, by at least such number of days prior to the day of the
meeting as required by Dutch law, which is currently 42 days.
Shareholders (as well as other persons with voting rights or meeting rights) may attend a General Meeting, to address the
General Meeting and, in so far as they have such right, to exercise voting rights pro rata to its shareholding, either in
person or by proxy. Shareholders may exercise these rights, if they are the holders of shares on the registration date
which is currently the 28th day before the day of a General Meeting, and they or their proxy have notified our Board of
Directors of their intention to attend a General Meeting in writing at the address and by the date specified in the notice of
said meeting.
All shareholders, and each usufructuary and pledgee to whom the right to vote on our shares accrues, are entitled, in
person or represented by a proxy authorized in writing, to attend and address a General Meeting and exercise voting
rights pro rata to their shareholding. Shareholders may exercise their rights if they are the holders of our shares on the
record date as required by Dutch law, which is currently the 28th day before the day of a General Meeting, and they or
their proxy have notified us of their intention to attend such General Meeting in writing or by any other electronic means
that can be reproduced on paper ultimately at a date set for that purpose by our Board of Directors which date may not be
earlier than the seventh day prior to such General Meeting, specifying such person’s name and the number of shares for
which such person may exercise the voting rights and/or meeting rights at such General Meeting. The convocation notice
shall state the record date and the manner in which the persons entitled to attend a General Meeting may register and
exercise their rights.
Each ordinary share confers the right on the holder to cast one vote at the General Meeting. Shareholders may vote by
proxy. The voting rights attached to any shares held by us are suspended as long as they are held in treasury.
Nonetheless, the holders of a right of usufruct (vruchtgebruik) in shares belonging to another and the holders of a right of
pledge in respect of ordinary shares held by us are not excluded from any right they may have to vote on such ordinary
shares, if the right of usufruct (vruchtgebruik) or the right of pledge was granted prior to the time such ordinary share
was acquired by us. We may not cast votes in respect of a share in respect of which there is a right of usufruct
(vruchtgebruik) or a right of pledge. Shares which are not entitled to voting rights pursuant to the preceding sentences
will not be taken into account for the purpose of determining the number of shareholders that vote and that are present or
represented, or the amount of the share capital that is provided or that is represented at a General Meeting.
Decisions of the General Meeting are taken by an absolute majority of votes cast, except where Dutch law or the Articles
of Association provide for a qualified majority or unanimity. In accordance with Dutch law and generally accepted
128 | ||
business practices, our Articles of Association do not provide quorum requirements generally applicable to a General
Meeting. To this extent, our practice varies from the requirement of Nasdaq Listing Rule 5620(c), which requires an
issuer to provide in its bylaws for a generally applicable quorum, and that such quorum may not be less than one-third of
the outstanding voting stock.
Two General Meetings were held in 2025.
At the 2025 General Meeting, our annual report and annual accounts for the year ended December 31, 2024 were
approved, the allocation of profits of the year ended December 31, 2024 to the retained earnings of the Company was
approved. Anthony Rosenberg was reappointed as a Non-Executive Director to the Board of Directors for a term of two
years, and the Board of Directors was authorized to issue shares and grant rights to subscribe for shares in our share
capital for up to 10% of the outstanding share capital at the date of the meeting and for a period of 18 months from the
meeting and to limit or exclude statutory pre-emptive rights with regard to such (rights to subscribe for) shares.
At the 2025 Extraordinary General Meeting, the 2025 Remuneration Policy was approved.
Limitations on the Right to Own Securities
Please see “Exhibit 2.3—Limitations on the Right to Own Securities”, incorporated herein by reference.
Comparison of Dutch Corporation Law, our Articles of Association and Board By-Laws and U.S. Corporate Law
Please see “Exhibit 2.3—Comparison of Dutch Corporate Law, our Articles of Association and Board of Directors By-
Laws and DGCL”, incorporated herein by reference.
Change in the Capital
C.MATERIAL CONTRACTS
For additional information on our material contracts, please see “Item 4 — Information on the Company”, “Item 7.A. —
D.EXCHANGE CONTROLS
Under Dutch law, subject to the 1977 Sanction Act (Sanctiewet 1977) and other international economic or financial
sanctions, there are no exchange control restrictions on investments in, or payments on, shares (except as to cash
amounts). There are no special restrictions in our Articles of Association or Dutch law that limit the right of shareholders
who are not citizens or residents of the Netherlands to hold or vote shares.
E.TAXATION
This summary does not consider your particular circumstances. We urge you to consult your own independent tax
advisors about the income, capital gains and/or transfer tax consequences to you in light of your particular
circumstances of purchasing, holding and disposing of ordinary shares or ADSs.
Certain Material U.S. Federal Income Tax Considerations for U.S. Holders
The following discussion is a summary under present law of certain material U.S. federal income tax considerations
relating to the ownership and disposition of ADSs by a U.S. holder (as defined below). This summary addresses only the
U.S. federal income tax considerations for U.S. holders that hold ADSs as capital assets (generally, property held for
investment) and use the U.S. dollar as their functional currency. This summary does not address all U.S. federal income
tax matters that may be relevant to a particular U.S. holder and is not a substitute for tax advice. This summary does not
address tax considerations applicable to a holder of ADSs that may be subject to special tax rules including, without
limitation, banks, financial institutions or insurance companies, brokers, dealers or traders in securities, currencies,
commodities, or notional principal contracts, traders in securities that elect to mark-to-market, tax-exempt entities or
organizations, including “individual retirement accounts” or “Roth IRAs”, real estate investment trusts, regulated
investment companies, persons that hold the ADSs as part of a “hedging,” “integrated” or “conversion” transaction or as
a position in a “straddle”, partnerships (including entities or arrangements classified as partnerships for U.S. federal
income tax purposes) or other pass-through entities (including
129 | ||
S-corporations), or persons that will hold the ADSs through such an entity, certain former citizens or
long-term residents of the United States, persons that received the ADSs as compensation for the performance of
services, persons subject to special tax accounting rules as a result of any item of gross income with respect to the shares
being taken into account in an applicable financial statement, and holders that own directly, indirectly, or through
attribution 10% or more of the voting power or value of our ordinary shares and ADSs. This summary does not address
U.S. federal taxes other than the income tax (such as the Medicare surtax on net investment income, the estate, gift, or
alternative minimum tax), any election to apply Section 1400Z-2 of the U.S. Internal Revenue Code of 1986, as amended
(the Code) to gains recognized with respect to ADSs, or any U.S. state, local, or non-U.S. tax considerations of the
ownership and disposition of ADSs.
For the purposes of this summary, a “U.S. holder” is a beneficial owner of ADSs that is (or is treated as), for U.S. federal
income tax purposes, (i) an individual who is a citizen or resident of the United States, (ii) a corporation, or any other
entity treated as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the
United States, any state thereof, or the District of Columbia, (iii) an estate, the income of which is subject to U.S. federal
income taxation regardless of its source, or a trust, if a court within the United States is able to exercise primary
supervision over its administration and one or more U.S. persons have the authority to control all of the substantial
decisions of such trust.
If a partnership (or other entity or arrangement treated as a partnership for U.S. federal income tax purposes) holds
ADSs, the U.S. federal income tax consequences relating to an investment in those ADSs will depend in part upon the
status of the partner and the activities of the partnership. A partnership that holds ADSs should consult its tax advisor
regarding the U.S. federal income tax considerations for it and for its partners of owning and disposing of ADSs in its
and their particular circumstances.
In general, a U.S. holder that owns ADSs will be treated as the beneficial owner of the underlying shares represented by
those ADSs for U.S. federal income tax purposes. Accordingly, no gain or loss will generally be recognized if a U.S.
holder exchanges ADSs for the underlying shares represented by those ADSs. Persons considering an investment in the
ADSs should consult their own tax advisors as to the particular tax consequences applicable to them relating to the
ownership and disposition of ADSs, including the applicability of U.S. federal, state and local tax laws and non-U.S. tax
laws.
Distributions
Although we do not currently plan to pay dividends, and subject to the discussion under “Item 10.E. — Taxation —
Certain Material U.S. Federal Income Tax Considerations for U.S. Holders — Passive Foreign Investment Company
Considerations” below, the gross amount of distributions paid with respect to our ordinary shares including Dutch or
Belgian tax withheld therefrom, if any (other than pro rata distribution), generally will be included in a U.S. holder’s
gross income as foreign source ordinary dividend income when actually or constructively received to the extent such
distribution is paid out of our current and accumulated earnings and profits as determined under U.S. federal income tax
principles. Distributions in excess of our current and accumulated earnings and profits will be treated as a non-taxable
return of capital and will be applied against and reduce, the U.S. holder’s adjusted tax basis in ADSs (but not below
zero) and distributions in excess of earnings and profits and a U.S. holder’s adjusted tax basis will generally be taxable to
the U.S. holder as either long-term or short-term capital gain depending upon whether the U.S. holder has held the ADSs
for more than one year as of the time such distribution is received. However, since we do not calculate our earnings and
profits under U.S. federal income tax principles, it is expected that any distribution will be reported as a dividend, even if
that distribution would otherwise be treated as a non-taxable return of capital or as capital gain.
Our dividends will not be eligible for the dividends-received deduction generally allowed to U.S. corporations.
Dividends paid to non-corporate U.S. holders that satisfy a minimum holding period (during which they are not
protected from the risk of loss) and certain other requirements may qualify for the preferential favorable tax rates
applicable to qualified dividend income, provided that we are a “qualified foreign corporation” and we are not a PFIC as
to the non-corporate U.S. holder in the taxable year of the dividend or the preceding taxable year. A qualified foreign
corporation includes a non-U.S. corporation that is eligible for the benefits of a comprehensive income tax treaties with
the United States. A non-U.S. corporation also will be considered to be a qualified foreign corporation with respect to
any dividend it pays on shares which are readily tradable on an established securities market in the United States. Our
ADSs are listed on Nasdaq, which is an established securities market in the United States, and we expect our ADSs to be
readily tradable on Nasdaq. However, there can be no assurance that the ADSs will be considered readily tradable on an
established securities market in the United States in any taxable year. U.S. holders should consult their own tax advisors
regarding the application of these rules given their particular circumstances.
Subject to generally applicable limitations, a U.S. holder may be entitled to claim a U.S. foreign tax credit for Dutch
withholding tax imposed at the appropriate rate. U.S. holders who do not elect to claim a credit for any foreign income
taxes paid or accrued during the taxable year may instead claim a deduction of such taxes. The rules relating to the
130 | ||
foreign tax credit are complex. Each U.S. holder should consult its own tax advisors regarding the foreign tax credit
rules.
In general, the amount of a distribution paid to a U.S. holder in a foreign currency will be the dollar value of the foreign
currency calculated by reference to the applicable exchange rate on the day the U.S. holder receives the distribution,
regardless of whether the foreign currency is converted into U.S. dollars at that time. Any foreign currency gain or loss a
U.S. holder realizes on a subsequent conversion of foreign currency into U.S. dollars will be U.S. source ordinary
income or loss. If dividends received in a foreign currency are converted into U.S. dollars on the day they are received, a
U.S. holder should not be required to recognize foreign currency gain or loss in respect of the dividend.
Sale, Exchange or Other Taxable Disposition of ADSs
Subject to the discussion under “Item 10.E. — Taxation—Certain Material U.S. Federal Income Tax Considerations for
U.S. Holders—Passive Foreign Investment Company Considerations” below, a U.S. holder will generally recognize
capital gain or loss on the sale, exchange or other taxable disposition of ADSs in an amount equal to the difference
between the amount realized from such sale or exchange and the U.S. holder’s adjusted basis in the ADSs, each amount
determined in USD. The adjusted tax basis in ADSs generally will be equal to the U.S. dollar cost of such ADSs. Any
such capital gain or loss generally will be long-term capital gain or loss if the U.S. holder’s holding period for such
ADSs exceeds one year as of the date of sale or other disposition. Long-term capital realized by a non-corporate U.S.
holder is generally eligible for a preferential reduced rates. The deductibility of capital losses for U.S. federal income tax
purposes is subject to certain limitations. Any such gain or loss that a U.S. holder recognizes generally will be treated as
U.S. source income or loss for foreign tax credit limitation purposes.
Passive Foreign Investment Company Considerations
In general, a non-U.S. corporation will be classified as a passive foreign investment company, or PFIC, for any taxable
year in which, after applying certain look-through rules with respect to certain dividends, rents, interest or royalties
received from its affiliates and taking into account its proportionate share of the income and assets of its 25% or more
owned subsidiaries, either: (i) at least 75% of its gross income is “passive income” or (ii) at least 50% of the average
quarterly value of its total gross assets is attributable to cash in excess of working capital requirements or assets that
produce “passive income” or are held for the production of “passive income”. Passive income for this purpose generally
includes dividends, interest, royalties, rents, gains from commodities and securities transactions, the excess of gains over
losses from the disposition of assets which produce passive income. While we are treated as a publicly traded company
for these purposes, the value of our assets, including goodwill and other intangibles, will be based on their fair market
value, which will depend on the market value of our ordinary shares and ADSs, which are subject to change.
Based on our historic and anticipated operations, the composition of our income and the projected composition and
estimated fair market values of our assets, we do not believe that we were a PFIC for our most recent taxable year and do
not expect to be classified as a PFIC for the current taxable year or for the foreseeable future. However, our possible
status as a PFIC is a factual determination made annually after the close of each taxable year and, therefore, may be
subject to change. Accordingly, there can be no assurance that we will not be a PFIC for any year in which a U.S. holder
holds ADSs. The Company does not intend to provide any annual assessments of its PFIC status.
If we were to be classified as a PFIC for any taxable year during which a U.S. holder owns ADSs, gain recognized on a
sale or other disposition (including certain pledges) of such U.S. holder’s ADSs would be allocated ratably over such
U.S. holder’s holding period. Amounts allocated to the taxable year of the sale or disposition and to any year before we
became a PFIC would be taxed as ordinary income and the amount allocated to each other taxable year would be subject
to tax at the highest rate in effect for individuals or corporations, as appropriate, for that taxable year, and an interest
charge will be imposed on the resulting tax liability for each such year. In addition, to the extent that distributions
received by a U.S. holder on its ADSs in any taxable year exceed 125% of the average of the annual distributions on
such holder’s ADSs received during the preceding three taxable years (or, if shorter, the U.S. holder’s holding period),
such excess distributions will be subject to taxation in the same manner. Furthermore, dividends that are not excess
distributions would not be eligible for the preferential tax rate applicable to qualified dividend income received by
individuals and certain other non-corporate persons.
If the Company is a PFIC for any taxable year during which you own ADSs, the Company will generally continue to be
treated as a PFIC with respect to you for all succeeding years during which you own the ADSs, even if the Company
ceases to meet the threshold requirements for PFIC status. Certain elections may be available that will result in
alternative treatments (such as mark-to-market treatment) of the Shares. U.S. holders should consult their own tax
advisors concerning the Company’s possible PFIC status and the consequences to them if the Company were a PFIC for
131 | ||
any taxable year, including whether any of these elections will be available, and, if so, what the consequences of the
alternative treatments will be in your particular circumstances.
Backup Withholding and Information Reporting
U.S. holders generally will be subject to information reporting requirements with respect to dividends on ADSs and on
the proceeds from the sale, exchange or disposition of the ADSs that are paid within the United States or through U.S.-
related financial intermediaries, unless the U.S. holder is a corporation or other “exempt recipient.” In addition, U.S.
holders may be subject to backup withholding on such payments, unless the U.S. holder provides a correct taxpayer
identification number and a duly executed IRS Form W-9 or otherwise establishes an exemption. Backup withholding is
not an additional tax, and the amount of any backup withholding will be allowed as a credit against a U.S. holder’s U.S.
federal income tax liability and may entitle such holder to a refund, provided that the required information is timely
furnished to the IRS.
Foreign Asset Reporting
Certain U.S. holders who are individuals and certain entities controlled by individuals may be required to report
information relating to an interest in ADSs, subject to certain exceptions (including an exception for shares held in
accounts maintained by U.S. financial institutions) by filing IRS Form 8938 (Statement of Specified Foreign Financial
Assets) with their federal income tax return. Investors who fail to report required information could become subject to
substantial penalties. U.S. holders are urged to consult their tax advisors regarding their information reporting
obligations, if any, with respect to their ownership and disposition of the ADSs.
Material Dutch Tax Consequences
The following summary outlines certain material Dutch tax consequences in connection with the acquisition, ownership
and disposal of the ADSs. All references in this summary to the Netherlands and Dutch law are to the European part of
the Kingdom of the Netherlands and its law, respectively, only. The summary does not purport to present any
comprehensive or complete picture of all Dutch tax aspects that could be of relevance to the acquisition, ownership and
disposal of the ADSs by a (prospective) holder of the ADSs. Depending on the particular situation of a holder of ADSs,
this summary may not describe all potentially relevant Dutch tax consequences in light of such a holder of
ADSs’ (specific) circumstances. The summary is based on the tax laws and practice of the Netherlands as in effect on the
date of this Annual Report, which are subject to changes that could prospectively or retrospectively affect the Dutch tax
consequences.
This summary does not address the Dutch tax consequences for a holder of ADSs that is considered to be affiliated
(gelieerd) to the Company within the meaning of the Dutch Withholding Tax Act 2021 (Wet bronbelasting 2021).
Generally, a holder of ADSs is considered to be affiliated to the Company for these purposes if (i) it has a qualifying
interest in the Company, (ii) the Company has a qualifying interest in such party, or (iii) a third party has a qualifying
interest in both the Company and such party. A party is equated with any qualifying unity (kwalificerende eenheid) of
parties of which it forms part. A qualifying unity is defined as entities that have been established and/or are acting jointly
with the primary purpose, or one of the primary purposes, to avoid the imposition of tax on one or more of such entities,
for example where the controlling interest (to be) held is divided into various non-controlling interests with the primary
purpose, or one of the primary purposes, to avoid the aforementioned tax. A qualifying interest is an interest that allows
the holder to have a decisive influence over the other party’s decisions, in such a way that it is able to determine the
activities of the other party. A party is in any case considered to have a qualifying interest in another party if it (directly
or indirectly) owns more than 50 per cent. of the voting rights in such other party.
For purposes of Dutch income and corporate income tax, shares, or certain other assets, which may include depositary
receipts in respect of shares, legally owned by a third party such as a trustee, foundation or similar entity or arrangement,
a “Third Party”, may under certain circumstances have to be allocated to the (deemed) settlor, grantor or similar
originator, the “Settlor”, or, upon the death of the Settlor, such Settlor’s beneficiaries, the “Beneficiaries”, in proportion
to their entitlement to the estate of the Settlor of such trust or similar arrangement, the “Separated Private Assets”.
The summary does not address the Dutch tax consequences of a holder of the ADSs who is an individual and who has a
substantial interest (aanmerkelijk belang) in the Company. Generally, a holder of the ADSs will have a substantial
interest in the Company if such holder of the ADSs, whether alone or together with such holder’s spouse or partner and/
or certain other close relatives, holds directly or indirectly, or as Settlor or Beneficiary of Separated Private Assets (i) (x)
the ownership of, (y) certain other rights, such as usufruct, over, or (z) rights to acquire (whether or not already issued),
shares (including the ADSs) representing 5% or more of the total issued and outstanding capital (or the issued and
outstanding capital of any class of shares) of the Company or (ii) (x) the ownership of, or (y) certain other rights, such as
usufruct over, profit participating certificates (winstbewijzen) that relate to 5% or more of the annual profit of the
Company or to 5% or more of the liquidation proceeds of the Company.
132 | ||
In addition, a holder of the ADSs has a substantial interest in the Company if such holder, whether alone or together with
such holder’s spouse or partner and/or certain other close relatives, has the ownership of, or other rights over, shares, or
depositary receipts in respect of shares, in, or profit certificates issued by, the Company that represent less than 5% of the
relevant aggregate that either (a) qualified as part of a substantial interest as set forth above and where shares, or
depositary receipts in respect of shares, profit certificates and/or rights there over have been, or are deemed to have been,
partially disposed of, or (b) have been acquired as part of a transaction that qualified for non-recognition of gain
treatment.
Furthermore, this summary does not address the Dutch tax consequences of a holder of the ADSs:
•who is an individual and receives income or realizes capital gains in respect of the ADSs in connection with such
holder’s employment activities or in such holder’s capacity as (former) board member or (former) supervisory board
member;
•who is a resident of any non-European part of the Kingdom of the Netherlands; or
•in respect of the Dutch Minimum Taxation Act 2024 (Wet minimumbelasting 2024), (which is the Dutch
implementation of Council Directive (EU) 2022/2523 of 14 December 2022 on ensuring a global minimum level of
taxation for multinational enterprise groups and large-scale domestic groups in the EU).
Dividend Withholding Tax
General
The Company is generally required to withhold dividend withholding tax imposed by the Netherlands at a rate of 15%
on dividends distributed by the Company in respect of our ordinary shares underlying the ADSs. The expression
“dividends distributed by the Company” as used herein includes, but is not limited to:
(a)distributions in cash or in kind, deemed and constructive distributions and repayments of paid-in capital (gestort
kapitaal) not recognized for Dutch dividend withholding tax purposes;
(b)liquidation proceeds, proceeds of redemption of our ordinary shares or, as a rule, consideration for the repurchase of
our ordinary shares by the Company in excess of the average paid-in capital recognized for Dutch dividend
withholding tax purposes;
(c)the par value of our ordinary shares issued to a holder of our ordinary shares or an increase of the par value of our
ordinary shares, to the extent that it does not appear that a contribution, recognized for Dutch dividend withholding
tax purposes, has been made or will be made; and
(d)partial repayment of paid-in capital, recognized for Dutch dividend withholding tax purposes, if and to the extent that
there are net profits (zuivere winst), unless (i) the shareholders at a General Meeting have resolved in advance to
make such repayment and (ii) the par value of our ordinary shares concerned has been reduced by an equal amount
by way of an amendment of our articles of association.
Holders of the ADSs Resident in the Netherlands
A holder of the ADSs that is an individual that is resident or deemed to be resident in the Netherlands for Dutch tax
purposes is generally entitled, subject to the anti-dividend stripping rules described below, to a full credit against its
income tax liability, or a full refund, of the Dutch dividend withholding tax.
A holder of the ADSs that is a legal entity that is resident or deemed to be resident in the Netherlands for Dutch tax
purposes is generally entitled, subject to the anti-dividend stripping rules described below, to a full credit against its
corporate income tax liability of the Dutch dividend withholding tax. If and to the extent such legal entity cannot credit
the full amount of Dutch dividend withholding tax in a given year, the Dutch dividend withholding tax may be carried
forward and credited against its corporate income tax liability in subsequent years (without time limitation).
The two previous paragraphs generally apply to holders of the ADSs that are neither resident nor deemed to be resident
in the Netherlands for Dutch tax purposes if the ADSs are attributable to a permanent establishment (vaste inrichting) or
a permanent representative (vaste vertegenwoordiger) in the Netherlands of such non-resident holder of ADSs.
A holder of the ADSs that is a legal entity that is resident or deemed to be resident in the Netherlands for Dutch tax
purposes that is exempt from Dutch corporate income tax but that is not qualifying exempt investment institution
133 | ||
(vrijgestelde beleggingsinstelling), is generally entitled, subject to the anti-dividend stripping rules described below, to
an exemption at source (subject to the completion of necessary procedural formalities) or a full refund of Dutch dividend
withholding tax on dividends received.
Holders of the ADSs Resident Outside the Netherlands
A holder of the ADSs that is resident in a country for tax purposes with which the Netherlands has a tax treaty in effect,
may, depending on the terms of such tax treaty and subject to the anti-dividend stripping rules described below, be
eligible for a full or partial exemption from, or full or partial refund of, Dutch dividend withholding tax on dividends
received.
A holder of the ADSs, that is a legal entity (a) tax resident in (i) an EU Member State, (ii) Iceland, Norway or
Liechtenstein, or (iii) a country with which the Netherlands has concluded a tax treaty that includes an article on
dividends and (b) that is in its state of residence under the terms of a tax treaty concluded with a third state, not
considered to be resident for tax purposes in a country with which the Netherlands has not concluded a tax treaty that
includes an article on dividends (i.e., not an EU Member State, Iceland, Norway or Liechtenstein), is generally entitled,
subject to the anti-abuse rules and the anti-dividend stripping rules described below, to a full exemption from Dutch
dividend withholding tax on dividends received if it holds an interest of, generally, at least 5% of the nominal share
capital of the Company in respect of which, had such holder been a tax resident in the Netherlands, the participation
exemption (deelnemingsvrijstelling) would have applied.
The full exemption from Dutch dividend withholding tax on dividends received by a holder of the ADSs is not granted if
(x) the interest held by such holder (i) is held for the avoidance of Dutch dividend withholding tax of another person as
(one of) the main purpose(s) and (ii) forms part of an artificial structure or series of structures (such as structures which
are not put into place for valid business reasons reflecting economic reality), or (y) the holder of ADSs has a similar
function to a qualifying investment institution (fiscale beleggingsinstelling) or a qualifying exempt investment institution
(vrijgestelde beleggingsinstelling).
A holder of the ADSs, that is an entity tax resident in (i) an EU Member State or (ii) Iceland, Norway or Liechtenstein,
or (iii) in a jurisdiction which has an arrangement for the exchange of tax information with the Netherlands (and such
holder as described under (iii) holds the ADSs as a portfolio investment (i.e., such holding is not acquired with a view to
the establishment or maintenance of lasting and direct economic links between the holder of the ADSs and the Company
and does not allow the holder of the ADSs to participate effectively in the management or control of the Company)),
which is exempt from tax in its country of residence and does not have a similar function to a qualifying investment
institution (fiscale beleggingsinstelling) or a qualifying exempt investment institution (vrijgestelde beleggingsinstelling),
and that would have been exempt from Dutch corporate income tax if it had been a resident of the Netherlands, is
generally entitled, subject to the anti-dividend stripping rules described below, to an exemption or a full refund of Dutch
dividend withholding tax on dividends received. This exemption or full refund will in general benefit certain foreign
pension funds, government agencies and certain government controlled commercial entities.
No exemption, reduction, credit or refund of Dutch dividend withholding tax will be granted if the recipient of the
dividend paid by the Company is not considered the beneficial owner (uiteindelijk gerechtigde) of the dividend. A
recipient of a dividend is in any case not considered the beneficial owner of the dividend pursuant to the anti-dividend
stripping rules if, as a consequence of a combination of transactions and tested at group level, (i) a person (other than the
holder of the dividend coupon), directly or indirectly, partly or wholly benefits from the dividend, (ii) such person
directly or indirectly retains or acquires a comparable interest in the ADSs, and (iii) such person is entitled to a less
favorable exemption, refund or credit of dividend withholding tax than the recipient of the dividend distribution. The
term “combination of transactions” includes transactions that have been entered into by parties related to the recipient of
the dividend, that have been entered into in the anonymity of a regulated stock market, the sole acquisition of one or
more dividend coupons and the establishment of short-term rights or enjoyment on the ADSs (e.g., usufruct).
Holders of the ADSs Resident in the U.S.
Dividends distributed by the Company to U.S. resident holders of the ADSs that are eligible for benefits under the
Convention between the Netherlands and the U.S. for the avoidance of Double Taxation and the Prevention of Fiscal
Evasion with respect to Taxes and Income, dated December 18, 1992 as amended by the protocol of March 8, 2004 (U.S.
Tax Treaty), generally will be entitled to a reduced dividend withholding tax rate of 5% in case of certain U.S. corporate
shareholders owning at least 10% of the Company’s total voting power. Certain U.S. pension funds and tax-exempt
organizations may qualify for a complete exemption from Dutch dividend withholding tax.
Under the U.S. Tax Treaty such benefits are generally available to U.S. residents if such resident is the beneficial owner
of the dividends, provided that such shareholder does not have an enterprise or an interest in an enterprise that is, in
whole or in part, carried on through a permanent establishment or permanent representative in the Netherlands and to
which enterprise or part of an enterprise the ADSs are attributable. A person may, however, not claim the benefits of the
134 | ||
U.S. Tax Treaty if such person’s entitlement to such benefits is limited by the provisions of Article 26 (the limitation on
benefits provision) of the U.S. Tax Treaty. The reduced dividend withholding tax rate can generally be applied at source
upon the distribution of the dividends, provided that the proper forms have been filed in advance of the distribution. In
the case of certain tax-exempt organizations, as a general rule, the so-called refund method applies; only when certain
administrative conditions have been fulfilled may such tax-exempt organization use the exemption method.
Irrespective of meeting the conditions of the relevant provisions of the U.S. Tax Treaty, dividends distributed by the
Company to a U.S. resident holder meeting the criteria set out in the second and third paragraphs under “
Taxes on Income and Capital Gains
Holders of the ADSs Resident in the Netherlands: Individuals
A holder of the ADSs, who is an individual resident or deemed to be resident in the Netherlands for Dutch tax purposes
will be subject to regular Dutch income tax on the income derived from the ADSs and the gains realized upon the
redemption and/or disposal of the ADSs by the holder thereof, if:
(a) such holder of the ADSs has an enterprise or an interest in an enterprise, to which enterprise the ADSs are
attributable; and/or
(b) such income or capital gain forms “a benefit from miscellaneous activities” (resultaat uit overige werkzaamheden)
which, for instance, would be the case if the activities with respect to the ADSs exceed “normal active asset
management” (normaal, actief vermogensbeheer) or if income and gains are derived from the holding, whether directly
or indirectly, of (a combination of) shares, debt claims or other rights (together, a “lucrative interest” (lucratief belang))
that the holder thereof has acquired under such circumstances that such income and gains are intended to be
remuneration for work or services performed by such holder (or a related person), whether within or outside an
employment relation, where such lucrative interest provides the holder thereof, economically speaking, with certain
benefits that have a relation to the relevant work or services.
If either of the above mentioned conditions (a) or (b) applies, income derived from the ADSs and the gains realized upon
the redemption and/or disposal of the ADSs will in general be subject to Dutch income tax at the progressive rates up to
49.5%.
If the above mentioned conditions (a) and (b) do not apply, a holder of the ADSs who is an individual, resident or
deemed to be resident in the Netherlands for Dutch tax purposes will not be subject to taxes on income and capital gains
in the Netherlands. Instead, such individual is generally taxed at a flat rate of 36% on deemed income from “savings and
investments” (sparen en beleggen), which deemed income is determined on the basis of the amount included in the
individual’s “yield basis” (rendementsgrondslag) at the beginning of the calendar year (minus a tax-free threshold; the
yield basis minus such threshold being the tax basis). For 2026, the deemed income derived from savings and
investments will be a percentage of the tax basis up to % that is determined based on the actual allocation of (i) savings,
(ii) other investments, and (iii) debts/liabilities within the individual’s yield basis. The tax-free threshold for 2026 is
€59,357. The percentages to determine the deemed income will be reassessed every year (with possible retroactive effect
to 1 January). A holder of the ADSs that is able to demonstrate that its tax liability is determined on the basis of the
deemed income derived from savings and investments that exceeds the “actual returns” (werkelijk rendement) of such
individual may under certain circumstances elect to be taxed on the basis of such “actual returns” (werkelijk rendement)
instead. These rules are subject to ongoing litigation and may therefore change. A holder of ADSs may need to file
(protective) appeals to any assessments based on these rules to benefit from any beneficial case law.
Holders of the ADSs Resident in the Netherlands: Corporate Entities
The income derived from the ADSs and the gains realized upon the redemption and/or disposal of the ADSs by any
holder of the ADSs that is an entity subject to corporate income tax in the Netherlands is generally subject to Dutch
corporate income tax levied at a rate of 25.8% (19% over profits up to and including €200,000), unless, and to the extent
that, the participation exemption (deelnemingsvrijstelling) applies.
Holders of the ADSs Resident Outside the Netherlands: Individuals
A holder of the ADSs who is an individual, not resident or deemed to be resident in the Netherlands will not be subject
to any Dutch taxes on income derived from the ADSs and the gains realized upon the redemption and/or disposal of the
ADSs, unless:
135 | ||
(a) such holder has an enterprise or an interest in an enterprise that is, in whole or in part, carried on through a permanent
establishment (vaste inrichting) or a permanent representative (vaste vertegenwoordiger) in the Netherlands and to which
enterprise or part of an enterprise, as the case may be, the ADSs are attributable; or
(b) such income or capital gain forms a “benefit from miscellaneous activities in the Netherlands” (resultaat uit overige
werkzaamheden in Nederland) which would for instance be the case if the activities in the Netherlands with respect to
the ADSs exceed “normal active asset management” (normaal, actief vermogensbeheer) or if such income and gains are
derived from the holding, whether directly or indirectly, of (a combination of) shares, debt claims or other rights
(together, a “lucrative interest” (lucratief belang)) that the holder thereof has acquired under such circumstances that
such income and gains are intended to be remuneration for work or services performed by such holder (or a related
person), in whole or in part, in the Netherlands, whether within or outside an employment relation, where such lucrative
interest provides the holder thereof, economically speaking, with certain benefits that have a relation to the relevant work
or services.
If either of the above mentioned conditions (a) or (b) applies, income derived from the ADSs and the gains realized upon
the redemption and/or disposal of the ADSs will in general be subject to Dutch income tax at the progressive rates up to
49.5%.
Holders of the ADSs Resident Outside the Netherlands: Legal and Other Entities
A holder of the ADSs, that is not an individual and that is not resident or deemed to be resident in the Netherlands for
corporate income tax purposes, will not be subject to any Dutch taxes on income derived from the ADSs and the gains
realized upon the redemption and/or disposal of the ADSs, unless:
•such holder has an enterprise or an interest in an enterprise that is, in whole or in part, carried on through a permanent
establishment (vaste inrichting) or a permanent representative (vaste vertegenwoordiger) in the Netherlands and to
which enterprise or part of an enterprise, as the case may be, the ADSs are attributable; or
•such holder has a substantial interest (aanmerkelijk belang) in the Company, that (i) is held for the avoidance of
Dutch income tax of another person as (one of) the main purpose(s) and (ii) forms part of an artificial structure or
series of structures (such as structures which are not put into place for valid business reasons reflecting economic
reality).
If either of the above mentioned conditions applies, income derived from the ADSs and the gains realized upon the
acquisition, redemption and/or disposal of the ADSs will, in general, be subject to Dutch regular corporate income tax,
levied at a rate of 25.8% (19% over profits up to and including €200,000), unless, and to the extent that, with respect to a
holder as described under (a), the participation exemption (deelnemingsvrijstelling) applies.
Gift, Estate and Inheritance Taxes
Holders of the ADSs Resident in the Netherlands
Gift tax may be due in the Netherlands with respect to an acquisition of the ADSs by way of a gift by a holder of the
ADSs who is resident or deemed to be resident of the Netherlands at the time of the gift.
Inheritance tax may be due in the Netherlands with respect to an acquisition or deemed acquisition of the ADSs by way
of an inheritance or bequest on the death of a holder of the ADSs who is resident or deemed to be resident of the
Netherlands, or in case of a gift by an individual who at the date of the gift was neither resident nor deemed to be
resident in the Netherlands, such individual dies within 180 days after the date of the gift, while that individual, at the
time of the individual’s death, is resident or deemed to be resident in the Netherlands.
For purposes of Dutch gift and inheritance tax, an individual with the Dutch nationality will be deemed to be resident in
the Netherlands if such individual has been resident in the Netherlands at any time during the 10 years preceding the date
of the gift or such individual’s death. For purposes of Dutch gift tax, an individual not holding the Dutch nationality will
be deemed to be resident of the Netherlands if such individual has been resident in the Netherlands at any time during the
12 months preceding the date of the gift.
Holders of the ADSs Resident Outside the Netherlands
No gift, estate or inheritance taxes will arise in the Netherlands with respect to an acquisition of the ADSs by way of a
gift by, or on the death of, a holder of the ADSs who is neither resident nor deemed to be resident of the Netherlands,
unless, in the case of a gift of the ADSs by an individual who at the date of the gift was neither resident nor deemed to be
136 | ||
resident in the Netherlands, such individual dies within 180 days after the date of the gift, while being resident or
deemed to be resident in the Netherlands.
Certain Special Situations
For purposes of Dutch gift, estate and inheritance tax, (i) a gift by a third party will be construed as a gift by the settlor,
and (ii) upon the death of the settlor, as a rule such settlor’s beneficiaries will be deemed to have inherited directly from
the settlor. Subsequently, such beneficiaries will be deemed the settlor, grantor or similar originator of the separated
private assets for purposes of the Dutch gift, estate and inheritance tax in case of subsequent gifts or inheritances.
For the purposes of the Dutch gift and inheritance tax, a gift that is made under a condition precedent is deemed to have
been made at the moment such condition precedent is satisfied. If the condition precedent is fulfilled after the death of
the donor, the gift is deemed to be made upon the death of the donor.
Value Added Tax
No Dutch value added tax will arise in respect of or in connection with the subscription, issue, placement, allotment or
delivery of the ADSs.
Other Taxes and Duties
No Dutch registration tax, capital tax, customs duty, transfer tax, stamp duty or any other similar documentary tax or
duty, other than court fees, will be payable in the Netherlands in respect of or in connection with the subscription, issue,
placement, allotment or delivery of the ADSs.
Residency
A holder of the ADSs will not be treated as a resident, or a deemed resident, of the Netherlands for tax purposes by
reason only of the acquisition, or the holding, of the ADSs or the performance by the Company under the ADSs.
Material Belgian Tax Consequences
The paragraphs below present a summary of certain Belgian federal income tax consequences of the ownership and
disposal of ADSs by an investor. This summary does not describe the tax treatment of investors that are subject to
special rules, such as banks, insurance companies, collective investment undertakings, dealers in securities or currencies,
persons that hold, or will hold, ADSs as a position in a straddle, share-repurchase transaction, conversion transactions,
synthetic security or other integrated financial transactions. The summary is based on laws, treaties and regulatory
interpretations in effect in Belgium on the date of this Annual Report, all of which are subject to change, including
changes that could have retroactive effect. Investors should appreciate that, as a result of evolutions in law or practice,
the eventual tax consequences may be different from what is stated below.
For the purposes of this summary, a resident investor is:
•an individual subject to Belgian personal income tax (personenbelasting/impôt des personnes physiques), i.e., (i) an
individual having its domicile in Belgium, (ii) when not having its domicile in Belgium, an individual having its seat
of wealth in Belgium, or (iii) an individual assimilated to a resident for purposes of Belgian tax law;
•a company subject to Belgian corporate income tax (vennootschapsbelasting/impôt des sociétés), i.e., a corporate
entity having its principal establishment, administrative seat or effective place of management in Belgium (and that is
not excluded from the scope of the Belgian corporate income tax); or
•a legal entity subject to the Belgian tax on legal entities (rechtspersonenbelasting/impôt des personnes morales), i.e., a
legal entity other than a company subject to Belgian corporate income tax having its principal establishment,
administrative seat or effective place of management in Belgium.
A non-resident investor is any person that is not a Belgian resident investor.
Investors should consult their own advisors regarding the tax consequences of an investment in the ADSs in light of their
particular situation, including the effect of any state, local or other national laws, treaties and regulatory interpretations
thereof
Dividends
137 | ||
For Belgian income tax purposes, the gross amount of all benefits paid on or attributed to the ADSs is generally treated
as a dividend distribution. By way of exception, the repayment of capital carried out in accordance with applicable Dutch
company law provisions is not treated as a dividend distribution to the extent that such repayment is imputed on fiscal
capital. This fiscal capital includes, in principle, the actual paid-up statutory share capital and, subject to certain
conditions, the paid-up share premiums and the cash amounts subscribed to at the time of the issue of profit-sharing
certificates. However, a repayment of capital is not fully imputed on fiscal capital if the company also has certain
reserves. Indeed, in such case, a reimbursement of capital is proratedly imputed on, on the one hand, fiscal capital and,
on the other hand, taxed reserves (whether or not incorporated in capital) and tax-exempt reserves incorporated in capital
(according to a specific priority rule). The part imputed on the reserves is treated as a dividend distribution subject to
applicable tax rules.
In general, a Belgian withholding tax of (currently) 30% is normally levied on dividends by any intermediary established
in Belgium that is in any way involved in the processing of the payment of non-Belgian sourced dividends (e.g., a
Belgian financial institution). For this purpose, “dividends” also include the price paid in case of a redemption of ADSs
(after deduction of the part of the fiscal capital represented by the redeemed ADSs) and, in the event of our liquidation,
any amounts distributed in excess of the fiscal capital.
However, no withholding tax will be triggered in case of a redemption which is carried out on a stock exchange and
meets certain conditions.
Further, the withholding tax rate is subject to such relief as may be available under applicable domestic or tax treaty
provisions.
Under Belgian law, non-Belgian dividend withholding tax is not creditable against Belgian income tax and is not
reimbursable to the extent that it exceeds Belgian income tax. Please refer to “Item 10.E. — Taxation — Certain
Material U.S. Federal Income Tax Considerations for U.S. Holders — Passive Foreign Investment Company
Considerations” for a description of withholding tax that may be imposed on dividends by the Netherlands.
Belgian Resident Individuals
For Belgian resident individuals who acquire and hold ADSs as a private investment, the Belgian dividend withholding
tax fully discharges their personal income tax liability. If (and only if) the dividend income would be declared in the
personal income tax return, it will be taxed at the lower of the generally applicable 30% Belgian withholding tax rate on
dividends or, in case globalization is more advantageous, at the progressive personal income tax rates applicable to the
taxpayer’s overall declared income. The first €833 (for income year 2026) (amount applicable per year and per taxpayer)
of the reported ordinary dividend income will be exempt from tax, subject to certain conditions. For the avoidance of
doubt, all reported dividends (not only dividends distributed on our ADSs) are taken into account to assess whether the
said maximum amount is reached.
If the dividends are reported, the Belgian dividend withholding tax levied at source may be credited against the personal
income tax due and is reimbursable to the extent that it exceeds the personal income tax due, provided that the dividend
distribution does not result in a reduction in value of or a capital loss on our ADSs. The latter condition is not applicable
if the individual can demonstrate that it has held ADSs in full legal ownership for an uninterrupted period of 12 months
prior to the payment or attribution of the dividends.
Belgian resident individual investors who acquire and hold the ADSs for professional purposes must always declare the
dividend income in their personal income tax return and will be taxable at the investor’s personal income tax rate
increased with local surcharges. Belgian withholding tax levied may be credited against the personal income tax due and
is reimbursable to the extent that it exceeds the income tax due, subject to two conditions: (i) the taxpayer must own the
ADSs in full legal ownership on the dividend record date and (ii) the dividend distribution may not result in a reduction
in value of or a capital loss on the ADSs. The latter condition is not applicable if the investor can demonstrate that it has
held the full legal ownership of the ADSs for an uninterrupted period of 12 months prior to the payment or attribution of
the dividends.
Belgian Resident Companies
Dividends received by Belgian resident companies are exempt from Belgian withholding tax provided that the investor
satisfies the identification requirements in Article 117, §11 of the Royal Decree implementing the Belgian Income Tax
Code (the BITC).
For Belgian resident companies, the gross dividend income (after deduction of any non-Belgian withholding tax but
including any Belgian withholding tax) must be declared in the corporate income tax return and will be subject to a
corporate income tax rate of 25%. Subject to certain conditions, a reduced corporate income tax rate of 20% applies on
the first €100,000 of taxable profits if the shareholder qualifies as a small company (kleine vennootschap), being a
company that, on the balance sheet date of the last completed financial year, has not exceeded more than one of the
138 | ||
following thresholds on a consolidated basis for two consecutive financial years: (i) an average annual number of 50
employees, (ii) an annual turnover excluding VAT of EUR 11,250,000 and (iii) a balance sheet total of €6,000,000 (cf.
Article 2, §1,5°, c)bis of the BITC in conjunction with Article 1:24, §1 to §6 of the Belgian Code on Companies and
Associations (BCCA) (a Small Company)).
As a general rule, Belgian resident companies may generally (although subject to certain limitations) deduct 100% of the
gross dividend received from their taxable income (Dividend Received Deduction) provided that at the time of a
dividend payment or attribution:
1.the Belgian resident company holds (A) ADSs representing at least 10% of our share capital or (B) a
participation with an acquisition value of at least €2,500,000 which (unless the shareholder is a Small
Company) qualifies as “fixed financial asset” (financiële vaste activa). The condition relating to the
qualification as “fixed financial asset” applies as of assessment year 2026;
2.the ADSs representing our share capital have been or will be held in full ownership for an uninterrupted period
of at least one year; and
3.the conditions described in Article 203 of the BITC (relating to the taxation of the underlying distributed
income and the absence of abuse), are met,
(together, the Conditions for the Application of the Dividend Received Deduction Regime).
Conditions (i) and (ii) above are, in principle, not applicable for dividends received by an investment company in the
meaning of Article 2, §1, 5°, f) BITC. The Conditions for the Application of the Dividend Received Deduction Regime
depend on a factual analysis and for this reason the availability of this regime should be verified upon each dividend
distribution.
Any Belgian dividend withholding tax levied at source can be credited against the ordinary Belgian corporate income tax
and is reimbursable to the extent it exceeds such corporate income tax, subject to two conditions: (i) the taxpayer must
own the ADSs in full legal ownership on the dividend record date and (ii) the dividend distribution does not result in a
reduction in value of or a capital loss on the ADSs. The latter condition is not applicable: (i) if the taxpayer demonstrates
that it has held the ADSs in full legal ownership for an uninterrupted period of 12 months immediately prior to the
payment or attribution of the dividends or (ii) if, during that period, the ADSs never belonged to a taxpayer other than a
Belgian resident company or a non-resident company that has, in an uninterrupted manner, invested the ADSs in a PE in
Belgium.
Belgian resident Organizations for Financing Pensions
For organizations for financing pensions (OFPs) i.e., Belgian pension funds incorporated under the form of an OFP
(organisme voor de financiering van pensioenen/organisme de financement de pensions) within the meaning of Article 8
of the Belgian Law of October 27, 2006, dividend income is generally tax exempt.
Subject to certain limitations, any Belgian dividend withholding tax levied at source may be credited against the
corporate income tax due and is reimbursable to the extent that it exceeds the corporate income tax due.
Belgian (or foreign) OFPs not holding the ADSs for an uninterrupted period of 60 days in full ownership results in a
rebuttable presumption that the arrangement (or a series of arrangements) is not genuine (kunstmatig/pas authentique)
and has been put in place for the main purpose or one of the main purposes of obtaining this withholding tax credit. The
withholding tax exemption will in such case not apply and/or any Belgian dividend withholding tax levied at source on
the dividends will in such case not be credited against the corporate income tax, unless counterproof is provided that the
arrangement or series of arrangements are genuine.
Other Belgian resident Taxable Legal Entities
For taxpayers subject to the Belgian income tax on legal entities, the Belgian dividend withholding tax in principle fully
discharges their income tax liability. If the dividend is paid outside Belgium without the intervention of a Belgian paying
agent and without the deduction of Belgian withholding tax, the legal entity is in principle required to declare and pay
the 30% withholding tax to the Belgian tax authorities.
Belgian Non-Resident Individuals and Companies
Dividend payments on the ADSs through a professional intermediary in Belgium will, in principle, be subject to the 30%
withholding tax, unless the shareholder is resident in a country with which Belgium has concluded a double taxation
139 | ||
agreement and delivers the requested affidavit. Non-resident investors can also obtain an exemption of Belgian dividend
withholding tax if they are the owners or usufructors of the ADSs and they deliver an affidavit confirming that they have
not allocated the ADSs to business activities in Belgium and that they are non-residents, provided that the dividend is
paid through a Belgian credit institution, stock market company or recognized clearing or settlement institution.
If the ADSs are acquired by a non-resident investor in connection with a business in Belgium, the investor must report
any dividends received, which are taxable at the applicable non-resident individual or corporate income tax rate, as
appropriate. Any Belgian withholding tax levied at source may be credited against the non-resident individual or
corporate income tax and is reimbursable to the extent it exceeds the income tax due, subject to two conditions: (i) the
taxpayer must own the ADSs in full legal ownership on the dividend record date and (ii) the dividend distribution does
not result in a reduction in value of or a capital loss on the ADSs. The latter condition is not applicable if (i) the non-
resident individual or the non-resident company demonstrates that the ADSs were held in full legal ownership for an
uninterrupted period of 12 months immediately prior to the payment or attribution of the dividends or (ii) with regard to
non-resident companies only, if, during the said period, the ADSs have not belonged to a taxpayer other than a resident
company or a non-resident company which has, in an uninterrupted manner, invested the ADSs in a Belgian PE.
Non-resident companies that have invested the ADSs in a Belgian establishment may deduct up to 100% of the gross
dividends included in their taxable profits if, at the date dividends are paid or attributed, the Conditions for Application
of the Dividend Received Deduction Regime are satisfied. Application of the Dividend Received Deduction depends,
however, on a factual analysis to be made upon each distribution and its availability should be verified upon each
distribution.
Capital Gains and Losses on ADSs
Belgian Resident Individuals
Under the current legislation, Belgian resident individuals acquiring the ADSs as a private investment should not be
subject to Belgian capital gains tax on the disposal of the ADSs; capital losses are not tax deductible.
However, the Belgian federal government has agreed to introduce a capital gains tax on financial assets (such as the
ADSs) for capital gains realized as from January 1, 2026 (the New Capital Gains Tax). This New Capital Gains Tax
would only apply to capital gains accrued as from January 1, 2026 (i.e. historical capital gains accrued until December
31, 2025 would not be subject to the tax). The New Capital Gains Tax must be adopted by the Belgian parliament prior
to coming into effect. It is expected that the New Capital Gains Tax will be adopted in the coming months and, once
adopted, it will apply to capital gains realized as from January 1, 2026.
Based on the draft texts currently available, the New Capital Gains Tax would comprise the following three categories of
capital gains:
•“Internal” capital gains: capital gains on ADSs sold to a transferee over which the transferor, either individually or
together with his spouse or descendants, ascendants, collateral relatives up to and including the second degree and
those of his spouse, exercises direct or indirect control as defined in article 1:14 of the BCCA. Such “internal” capital
gains would be subject to a 33% tax rate;
• “Significant Stake” capital gains: capital gains on ADSs realized within the ‘normal management of private estate’ if
the transferor, at the moment of the transfer, holds a participation of at least 20% in the company whose shares are
being transferred (a Significant Stake). The first €1,000,000 of capital gain on a Significant Stake would be exempt
(such exempt tranche being available per period of five years). The capital gain exceeding €1,000,000 would be
subject to progressive rates: 1.25% on capital gains between €1,000,000 and €2,500,000; 2.5% on capital gains
between €2,500,000 and EUR 5,000,000; 5% on capital gains between €5,000,000 and €10,000,000 and 10% on
capital gains exceeding €10,000,000;
•“Other” capital gains: capital gains on financial assets (such as the ADSs) realized within the ‘normal management of
private estate’, other than “internal” capital gains or capital gains on a “Significant Stake” (as described above). The
applicable rate would be 10%. An annual exemption will be provided for up to €10,000, which may be increased by
up to €1,000 for each year in which the exemption is not (fully) used, up to a maximum of €15,000 after five years
(amounts to be indexed). Based on the draft texts currently available, it is intended that the tax on ‘other’ capital gains
would generally be levied via withholding tax (subject to certain exceptions).
Capital losses on the disposal of the ADSs would be deductible from capital gains realized in the same taxable year, by
the same taxpayer and within the same “category” of taxable capital gains on financial assets (as described above)
140 | ||
However, capital gains which are deemed to be realized outside the scope of the ‘normal management of the individual’s
private estate’ are taxable at 33% (plus local surcharges).
Under the current legislation, Belgian resident individuals who hold the ADSs for professional purposes are taxable at
the ordinary progressive personal income tax rates (plus local surcharges) on any capital gains realized upon the disposal
of the ADSs, except for shares held for more than five years, which are taxable at a separate rate of 16.5% or (if the
capital gain is realized in the framework of the cessation of activities and under certain circumstances) 10% (in each case
plus local surcharges). Capital losses on the ADSs incurred by Belgian resident individuals who hold the ADSs for
professional purposes are in principle tax deductible.
Based on the draft texts currently available, the application of the New Capital Gains Tax could be triggered if Belgian
resident individuals transfer their place of residence or seat of wealth outside of Belgium, subject to conditions and
exemptions.
Belgian Resident Companies
Belgian resident companies are normally not subject to Belgian capital gains taxation on gains realized upon the disposal
of our ADSs provided that the Conditions for the Application of the Dividend Received Deduction Regime (see above
under “Dividends—Belgian Resident Companies”) are met. If one of the Conditions for Dividend Received Deduction is
not met, the capital gains realized upon the disposal of our ADSs by a Belgian resident company are taxable at the
ordinary corporate income tax rate of, currently, 25%, unless the reduced corporate income tax rate of 20% on the first
€100,000 of taxable profits applies (see above).
Capital losses on our ADSs incurred by resident companies are as a general rule not tax deductible.
Our ADSs held in the trading portfolios (handelsportefeuille/portefeuille commercial) of qualifying credit institutions,
investment enterprises and management companies of collective investment undertakings which are subject to the Royal
Decree of 23 September 1992 on the annual accounts of credit institutions, investment firms and management companies
of collective investment undertakings (Koninklijk besluit van 23 september 1992 op de jaarrekening van de
kredietinstellingen, de beleggingsondernemingen en de beheervennootschappen van instellingen voor collectieve
belegging/ arrêté royal du 23 septembre 1992 relatif aux comptes annuels des établissements de crédit, des entreprises
d’investissement et des sociétés de gestion d’organismes de placement collectif) are subject to a different regime. The
capital gains on such shares are taxable at the ordinary corporate income tax rate of 25%. Capital losses on such shares
are tax deductible. Internal transfers to and from the trading portfolio are assimilated to a realization.
Capital gains realized by Belgian resident companies (both ordinary Belgian resident companies and qualifying credit
institutions, investment enterprises and management companies of collective investment undertakings) upon the
redemption of our ADSs or upon our liquidation are, in principle, subject to the same taxation regime as dividends. Refer
Belgian resident OFPs
OFPs are, in principle, not subject to Belgian capital gains taxation realized upon the disposal of the ADSs, and capital
losses are not tax deductible.
Capital gains realized by Belgian OFPs upon the redemption of ADSs or upon our liquidation will in principle be taxed
as dividends.
Other Belgian Taxable Legal Entities
Under the current legislation, Belgian resident legal entities subject to the legal entities income tax are, in principle, not
subject to Belgian capital gains taxation on the disposal of ADSs. Capital losses on ADSs incurred by Belgian resident
legal entities are not tax deductible.
However, the Belgian government has agreed to introduce a New Capital Gains Tax on financial assets (such as the
ADSs) from January 1, 2026 onwards (see “Belgian Resident Individuals” above). Based on the draft texts currently
available, this capital gains tax will also be due by legal entities subject to Belgian legal entities tax, except entities that
are entitled to receive tax-deductible gifts.
Capital gains realized by Belgian resident legal entities upon the redemption of ADSs or upon our liquidation will in
principle be taxed as dividends.
Belgian Non-Resident Individuals and Companies
141 | ||
Non-resident individuals or companies are, in principle, not subject to Belgian income tax on capital gains realized upon
disposal of the ADSs, unless such ADSs are held as part of a business conducted in Belgium through a Belgian
establishment. In such a case, the same principles apply as described with regard to Belgian individuals (holding the
shares for professional purposes) or Belgian companies.
Non-resident individuals who do not use the shares for professional purposes and who have their fiscal residence in a
country with which Belgium has not concluded a tax treaty or with which Belgium has concluded a tax treaty that
confers the authority to tax capital gains on the ADSs to Belgium, might be subject to tax in Belgium if the capital gains
are obtained or received in Belgium and arise from transactions which are to be considered speculative or beyond the
normal management of one’s private estate. Refer to Item 10.E. — “Taxation — Certain Material U.S. Federal Income
Tax Considerations for U.S. Holders — Passive Foreign Investment Company Considerations”. Such non-resident
individuals might therefore be obliged to file a tax return and should consult their own tax advisor. However, Belgium
has concluded tax treaties with more than 95 countries which generally provide for a full exemption from Belgian capital
gains taxation on such gains realized by residents of those countries. However, the draft texts relating to the New Capital
Gains Tax provide for the repeal of the provisions of the BITC that allow capital gains realized by Belgian non-residents
who do not hold the ADSs for professional purposes to be subject to tax in Belgium. As a result, capital gains realized by
Belgian non-residents outside the scope of a professional activity could no longer be taxable in Belgium.
Capital gains realized by non-resident individuals or non-resident companies upon the redemption of ADSs or upon our
liquidation will, in principle, be subject to the same taxation regime as dividends.
142 | ||
Tax on Stock Exchange Transactions
Upon the issue of the ADSs (primary market), no Tax on Stock Exchange Transactions (taks op beursverrichtingen/taxe
sur opérations de bourse) is due.
The purchase and the sale and any other acquisition or transfer for consideration of ADSs (secondary market
transactions) is subject to the Tax on Stock Exchange Transactions if (i) it is executed in Belgium through a professional
intermediary, or (ii) deemed to be executed in Belgium, which is the case if the order is directly or indirectly made to a
professional intermediary established outside of Belgium, either by private individuals with habitual residence in
Belgium, or legal entities for the account of their seat or establishment in Belgium (both, a Belgian Investor).
The Tax on Stock Exchange Transactions is levied at a rate of 0.35% of the purchase price, capped at €1,600 per
transaction and per party.
A separate tax is due by each party to the transaction, and both taxes are collected by the professional intermediary.
However, if the intermediary is established outside of Belgium, the tax will in principle be due by the Belgian Investor,
unless that Belgian Investor can demonstrate that the tax has already been paid. Professional intermediaries established
outside of Belgium can, subject to certain conditions and formalities, appoint a Belgian Stock Exchange Tax
Representative, which will be liable for the Tax on Stock Exchange Transactions in respect of the transactions executed
through the professional intermediary. If the Stock Exchange Tax Representative would have paid the Tax on Stock
Exchange Transactions due, the Belgian Investor will, as per the above, no longer be the debtor of the Tax on Stock
Exchange Transactions.
No Tax on Stock Exchange Transactions is due on transactions entered into by the following parties, provided they are
acting for their own account: (i) professional intermediaries described in Article 2, 9° and 10° of the Belgian Law of
August 2, 2002; (ii) insurance companies described in Article 2, §1 of the Belgian Law of July 9, 1975; (iii) professional
retirement institutions referred to in Article 2, 1° of the Belgian Law of October 27, 2006 concerning the supervision on
institutions for occupational pension; (iv) collective investment institutions; (v) regulated real estate companies; and (vi)
Belgian non-residents provided they deliver a certificate to their financial intermediary in Belgium confirming their non-
resident status.
Annual Tax on Securities Accounts
The Belgian Annual Tax on Securities Accounts is a subscription tax, levied on securities accounts and not on the
holders thereof. A securities account is defined as an account on which financial instruments can be credited and debited.
The tax applies to securities accounts held both in Belgium and abroad when the account holder is a Belgian resident or
when the account forms part of the assets of a Belgian establishment of a non-Belgian resident. The tax applies to natural
persons residing in Belgium, as well as to companies and legal entities (subject to the tax for legal entities) that are
established in Belgium.
The tax is also applicable to securities accounts held by non-Belgian residents (both natural persons and legal persons) if
the securities account is held in Belgium. If the applicable double tax treaty however allocates the right to tax capital to
the jurisdiction of residence, Belgium would be prevented from applying the Annual Tax on Securities Accounts to the
Belgian securities accounts held by non-Belgian residents. As described above, the tax applies whether or not the
account is held in Belgium if the account forms part of the assets of a Belgian establishment of a non-Belgian resident.
The Annual Tax on Securities Accounts is applicable to securities accounts of which the average value of the assets
amounts to more than €1,000,000 during the reference period. In principle, this reference period starts on 1 October and
ends on 30 September of the following year. The aforementioned threshold is assessed on the average value of the assets
in the securities account at reference points within the reference period (in principle December 31st, March 31st, June
30th and September 30th). The threshold is assessed per securities account and not per account holder.
The applicable tax rate is 0.15%, which is levied on the average value of the assets held in the securities account that
exceeds the €1,000,000 threshold. It is however limited to 10% of the difference between the average value and the
threshold of €1,000,000, in order to avoid that the Annual Tax on Securities Accounts would result in reducing the value
of the securities account below the €1,000,000 threshold. However, as part of the federal budget agreement, the Belgian
government announced that the applicable tax rate would be increased from 0.15% to 0.30%. This change should
nevertheless first be adopted by the Belgian parliament prior to coming into effect.
The Annual Tax is in principle withheld, reported and paid by the Belgian intermediary. If the intermediary is
established outside of Belgium, the tax must in principle be reported and paid by the account holder, unless the account
holder can demonstrate that the tax has already been reported and paid by an intermediary. Intermediaries established
143 | ||
outside of Belgium can, subject to certain conditions and formalities, appoint a Belgian Annual Tax on Securities
Accounts Representative, which will be liable for reporting and paying the Annual Tax on Securities Accounts in respect
of securities accounts in scope of the Annual Tax that are held through such intermediaries. If the Annual Tax on
Securities Accounts Representative would have paid the Annual Tax on Securities Accounts due, the account holder
will, as per the above, no longer be the debtor of the Annual Tax on Securities Accounts.
The Annual Tax on Securities Accounts is however not applicable to securities accounts held by certain categories of
account holders active in the financial or fund sector, as listed in the relevant legislation (e.g. credit institutions,
insurance companies, investment companies, and certain collective investment undertakings). These exemptions do
however not apply if a non-qualifying third party has a direct or indirect claim on the value of the securities account.
Applicable as of July 29, 2025, a new specific anti-abuse rule (SAAR) in relation to the annual tax on securities accounts
was introduced. The SAAR introduces a presumption of abuse in case of (i) a conversion of financial instruments
registered in a securities account into similar instruments that are not registered in such an account (e.g. dematerialized
securities into registered securities), if before the conversion the total value of the taxable financial instruments in the
account exceeded €1,000,000, and (ii) a transfer of securities from one securities account to one or more other securities
account(s), if before such transfer the total value of taxable instruments in the account exceeded €1,000,000 and
provided that (a) the securities account holders of the accounts involved are the same, or (b) the transferring account
holder is a joint holder of the receiving account. The application of the SAAR may be refuted if it is demonstrated that
the transaction is mainly justified by a motive other than the avoidance of the annual tax on securities accounts.
The financial intermediary established or located in Belgium or the Belgian annual tax on securities accounts
representative must notify the transactions mentioned under (i) and (ii) above to the tax authorities ultimately by the last
day of the month following the end of the relevant reference period. If it concerns a foreign securities account for which
no Belgian annual tax on securities accounts representative is indicated, the notification should occur by the holder of the
securities accounts itself.
Prospective investors are strongly advised to seek their own professional advice in relation to the possible impact of the
Annual Tax on Securities Accounts on their own personal tax position.
Enforcement of civil liabilities
We are a European public company with limited liability (Societas Europaea or SE) incorporated under the laws of the
Netherlands. A majority of our assets are located outside the U.S. As a result, it may not be possible or it may be difficult
for investors to effect service of process within the U.S. upon such persons or the Group, or to enforce against them or us
in U.S. courts, including judgments predicated upon the civil liability provisions of the federal securities laws of the U.S.
The U.S. and the Netherlands currently do not have a treaty providing for the reciprocal recognition and enforcement of
judgments, other than arbitration awards, in civil and commercial matters. Consequently, a final judgment (for payment)
given by a court in the U.S., whether or not predicated solely upon U.S. securities laws, would not automatically be
recognized or enforceable in the Netherlands. In order to obtain a judgment which is enforceable in the Netherlands, the
party in whose favor a final and conclusive judgment of the U.S. court has been rendered will be required to file its claim
with a court of competent jurisdiction in the Netherlands. Such party may submit to the Dutch court the final judgment
rendered by the U.S. court. This court will have a level of discretion in its assessment of the judgment rendered by the
relevant U.S. court. On the basis of case law by the Dutch Supreme Court, Dutch courts will in principle have to give
conclusive effect to a final and enforceable judgment of such court in respect of the contractual obligations thereunder
without re-examination or re-litigation of the substantive matters adjudicated upon, provided that: (i) the jurisdiction of
the U.S. court has been based on a ground of jurisdiction that is generally acceptable according to international
standards, (ii) the judgment by the U.S. court was rendered in legal proceedings that comply with the Dutch standards of
the proper administration of justice that includes sufficient safeguards (behoorlijke rechtspleging), (iii) the judgment by
the U.S. court does not contravene Dutch public policy (openbare orde), and (iv) the judgment by the U.S. court is not
irreconcilable with a judgment of a Dutch court or an earlier judgment of a foreign court rendered between the same
parties that is capable of being recognized in the Netherlands. Even if such foreign judgments is given binding effect, a
claim based thereon may, however, still be rejected if the foreign judgment is not or no longer formally enforceable in
the country of origin. In addition, there can be no assurance that civil liabilities predicated upon the federal or state
securities laws of the United States will be enforceable in the Netherlands or any other jurisdiction. Enforcement and
recognition of judgments of U.S. courts in the Netherlands are solely governed by the provisions of the Dutch Civil
Procedure Code (Wetboek van Burgerlijke Rechtsvordering). Judgments may be rendered in a foreign currency, but
enforcement is executed in euro at the applicable rate of exchange. Under certain circumstances, a Dutch court has the
power to stay proceedings (aanhouden) or to declare that it has no jurisdiction if concurrent proceedings are being
brought elsewhere. Moreover, a Dutch court may reduce the amount of damages granted by a U.S. court and recognize
damages only to the extent that they are necessary to compensate actual losses or damages.
Original actions or actions for the enforcement of judgments of U.S. courts relating to the civil liability provisions of the
federal or state securities laws of the U.S. are not directly enforceable in Belgium. The U.S. and Belgium currently do
144 | ||
not have a treaty providing for reciprocal recognition and enforcement of judgments, other than arbitral awards, in civil
and commercial matters. Consequently, a final judgment for payment given by a court in the U.S., whether or not
predicated solely upon U.S. securities laws, would not automatically be recognized or enforceable in Belgium. In order
for a final judgment for the payment of money rendered by U.S. courts based on civil liability to produce any effect on
Belgian soil, it is accordingly required that this judgment be recognized and be declared enforceable by a Belgian court
pursuant to the relevant provisions of the PIL Code. Recognition or enforcement does not imply a review of the merits of
the case and is irrespective of any reciprocity requirement. A U.S. judgment will, however, not be recognized or declared
enforceable in Belgium if it infringes upon one or more of the grounds for refusal which are exhaustively listed in article
25 of the PIL Code. In addition to recognition or enforcement, a judgment by a federal or state court in the U.S. against
us may also serve as evidence in a similar action in a Belgian court if it meets the conditions required for the authenticity
of judgments according to the law of the state where it was rendered. In addition, with regard to enforcements by legal
proceedings in Belgium (including the recognition of foreign court decisions in Belgium), a registration tax at the rate of
3% of the amount of the judgment is payable by the debtor, if the sum of money which the debtor is ordered to pay by a
Belgian court, or by a foreign court judgment that is either (i) automatically enforceable and registered in Belgium, or (ii)
rendered enforceable by a Belgian court, exceeds €12,500. The registration tax is payable by the debtor. The debtor is
liable for the payment of the registration tax, in the proportion determined by the decision ordering payment or
liquidation or determining priority for creditors made or established against it. The debtor(s) are jointly and severally
liable in the event that they are ordered to pay jointly and severally. A stamp duty is payable as of the second certified
copy of an enforcement judgment rendered by a Belgian court, with a maximum of €1,450.
Dutch and Belgian civil procedure differ substantially from U.S. civil procedure in a number of respects. Insofar as the
production of evidence is concerned, U.S. law and the laws of several other jurisdictions based on common law provide
for pre-trial discovery, a process by which parties to the proceedings may prior to trial compel the production of
documents by adverse or third parties and the deposition of witnesses. Evidence obtained in this manner may be decisive
in the outcome of any proceeding. No such pre-trial discovery process exists under Dutch or Belgian law.
Subject to the foregoing and service of process in accordance with applicable treaties, investors may be able to enforce in
the Netherlands or Belgium judgments in civil and commercial matters obtained from U.S. federal or state courts.
However, no assurance can be given that those judgments will be enforceable. In addition, it is doubtful whether a Dutch
or Belgian court would accept jurisdiction and impose civil liability in an original action commenced in the Netherlands
or Belgium and predicated solely upon U.S. federal securities laws.
F.DIVIDENDS AND PAYING AGENTS
Not applicable.
G.STATEMENT BY EXPERTS
Not applicable.
H.DOCUMENTS ON DISPLAY
We are subject to the information reporting requirements of the U.S. Securities Exchange Act of 1934, as amended
(Exchange Act) applicable to foreign private issuers. Accordingly, we are required to file reports and other information
with the SEC. Those reports may be inspected without charge at the locations described below. As a foreign private
issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements,
and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery
provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file
periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities
are registered under the Exchange Act. Nevertheless, we will file with the SEC an Annual Report containing financial
statements that have been examined and reported on, with an opinion expressed by an independent registered public
accounting firm.
We maintain a corporate website at www.argenx.com. We make available on our website, free of charge, our Annual
Report and the text of our reports on Form 6-K, including any amendments to these reports, as well as certain other SEC
filings, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC. Information
contained on, or that can be accessed through, our website does not constitute a part of this Annual Report. We have
included our website address in this Annual Report solely as an inactive textual reference.
The SEC maintains a website (www.sec.gov) that contains reports and other information regarding registrants, such as
argenx SE, that file electronically with the SEC.
145 | ||
With respect to references made in this Annual Report to any contract or other document of argenx SE, such references
are not necessarily complete and you should refer to the exhibits attached or included elsewhere to this Annual Report
for copies of the actual contract or document.
I.SUBSIDIARY INFORMATION
Not applicable.
ITEM 11.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We take a centralized approach to managing our exposure to market risks globally. We coordinate our access to national
and international financial markets and consider and manage continuously the financial risks concerning our activities.
These risks relate to the adequacy of our equity and debt capitalization, the creditworthiness of our counterparties, our
short-term liquidity, the impact of changes in interest rates on our investments and fluctuations in foreign currency
exchange rates. We do not believe that risks relating to interest rates on borrowings are material as the Company has no
financial debt. We do not buy or trade financial instruments for speculative purposes. For additional information on risk
factors applicable to the Company, its business, financial condition and results of operations, please see “Item 3.D. —
Risk Factors.” See “Note 24 — Financial Risk Management’’ to our consolidated financial statements appended in our
Annual Report and incorporated by reference herein.
Capital risk
The Company manages its capital to ensure that it will be able to continue as a going concern. The capital structure of
the Company consists of equity attributed to the holders of equity instruments of the Company, such as capital, reserves
and accumulated losses as mentioned in the consolidated statements of changes in equity. The Company makes the
necessary adjustments in light of changes in the economic circumstances, risks associated to the different assets and the
projected cash needs of the current and projected research activities. On December 31, 2025, cash and cash equivalents
amounted to $3.5 billion, current financial assets amounted to $0.9 billion and total capital amounted to $7.3 billion. The
current cash situation and the anticipated cash generation and usage are the most important parameters in assessing the
capital structure. The Company’s objective is to maintain the capital structure at a level to be able to finance its activities
for at least twelve months. Cash income from operations is taken into account and, if needed and possible, the Company
can enter into financing agreements or issue new shares.
Credit risk
Credit risk refers to the risk that a counterparty will default on its contractual obligations resulting in financial loss to the
Company. The Company has adopted a policy of only dealing with creditworthy counterparties and obtaining sufficient
collateral, where appropriate, as a means of mitigating the risk of financial loss from defaults. Concentrations in credit
risk are determined based on an analysis of counterparties and their importance on the overall outstanding contractual
obligations at year-end.
The Company's commercial revenue are concentrated as discussed in “Note 16 — Segment Reporting”, on a limited
number of U.S. customers with high quality creditworthiness. The Company sets customer specific credit limits in order
to reduce credit risk from commercial payors.
The Company applied the IFRS 9 simplified approach to measuring expected credit losses which uses a lifetime
expected loss allowance for trade receivables. To measure the expected credit losses, receivables have been grouped
based on credit risk characteristics and the days past due. The provision for expected credit losses was not significant
given that there have been no significant credit losses over the last three years and the high quality nature of the
Company’s customers.
Cash and cash equivalents and current financial assets are invested with several highly reputable banks and financial
institutions. The main purpose of the Cash Investment Policy is to preserve the available cash and to ensure sufficient
short-term liquidity at all times. Therefore, the Company holds its cash and cash equivalents, in addition to current
financial assets mainly with banks which are independently rated A- or higher. Amounts of cash held with banks rated
lower than A- are limited to insignificant balances. The maximum amount and tenor of term accounts depends on the
rating of the counterparty bank. The Company also holds cash equivalents in the form of money market funds with a low
historical volatility. These money market funds are highly liquid investments and can be readily convertible into a
known amount of cash. The company has adopted a policy whereby money market funds must have a minimum rating of
A, and whereby 95% of its money market funds should have a AAA-rating.
146
Liquidity risk
The Company manages liquidity risk by maintaining adequate reserves, by continuously monitoring forecast and actual
cash flows, and by matching the maturity profile of financial assets and liabilities.
The Company’s main sources of cash are the sale of commercial product and exercise of stock options. This cash is
invested in savings accounts, term accounts and money market funds. These money market funds represent the majority
of the Company’s available sources of liquidity. Since all of these are immediately tradable and convertible in cash they
have an important mitigating effect on any short-term liquidity risk.
As of December 31, 2025, the Company had lines of credit totaling $29 million with financial institutions mainly
relating to leasing guarantees.
Interest rate risk
The only variable interest-bearing financial instruments are cash and cash equivalents and current financial assets.
Changes in interest rates may cause variations in interest income resulting from short-term interest-bearing assets. Lower
short-term interests may have a negative impact on the interest income of the Company.
For the year ended December 31, 2025, if applicable interest rates would increase/decrease by 50 basis points, this would
have a positive/negative impact of $22 million (compared to $8 million for the year ended December 31, 2024 and $8
million for the year ended December 31, 2023 if applicable interest rates would increase/decrease by 25 basis points).
Foreign exchange risk
The Company undertakes transactions denominated in foreign currencies, causing exposures to exchange rate
fluctuations. The Company is mainly exposed to the Euro, Japanese yen, British pound and Swiss franc. To limit this
risk, the Company attempts to align incoming and outgoing cash flows in currencies other than USD. The Company
further limits its non-USD liquidity holdings when possible.
The net exposure to exchange differences of the monetary assets (being from cash and cash equivalents, in addition to
current financial assets) of the Company at the end of the reporting period are as follows:
As of December 31, | ||||||
(in thousands of $) | 2025 | 2024 | 2023 | |||
EUR | 155,757 | 756,676 | 923,773 | |||
Other currencies | 1,258 | 1,679 | 8,708 | |||
On December 31, 2025, if the EUR would have strengthened/weakened versus the USD by 10 %, this would have had a
negative/positive impact of $16 million, compared to $76 million and $92 million on December 31, 2024 and
December 31, 2023, respectively. If other currencies would have strengthen or weakened against the USD by 10%, this
would have had no significant impact in all reported periods.
ITEM 12.DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A.DEBT SECURITIES
Not applicable.
B.WARRANTS AND RIGHTS
Not applicable.
C.OTHER SECURITIES
Not applicable.
147
D.AMERICAN DEPOSITARY SHARES
In connection with our initial public offering on Nasdaq, the Bank of New York Mellon, as depositary, registered and
delivered ADSs. Each ADS represents one share (or a right to receive one share) deposited with ING Bank N.V., as
custodian for the depositary in the Netherlands. Each ADS also represents any other securities, cash or other property
which may be held by the depositary. The deposited shares together with our other securities, cash and other property
held by the depositary, are referred to as the deposited securities. The depositary’s office at which the ADSs are
administered is located at 101 Barclay Street, New York, New York 10286. The Bank of New York Mellon’s principal
executive office is located at 225 Liberty Street, New York, New York 10286.
A deposit agreement among us, the depositary, ADS holders and all other persons indirectly or beneficially holding
ADSs sets out ADS holder rights as well as the rights and obligations of the depositary. New York law governs the
deposit agreement and the ADSs.
Fees and Charges
Persons depositing or withdrawing shares or ADS holders must pay: | For: | |
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs) | Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property | |
Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates | ||
$.05 (or less) per ADS | Any cash distribution to ADS holders | |
A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs | Distribution of securities distributed to holders of deposited securities (including rights) that are distributed by the depositary to ADS holders | |
$.05 (or less) per ADS per calendar year | Depositary services | |
Registration or transfer fees | Transfer and registration of shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw shares | |
Expenses of the depositary | Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement) | |
Converting foreign currency to USDs | ||
Taxes and other governmental charges the depositary or the custodian has to pay on any ADSs or shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding taxes | As necessary | |
Any charges incurred by the depositary or its agents for servicing the deposited securities | As necessary |
The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or
surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for
making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of
distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from
cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for
them. The depositary may collect any of its fees by deduction from any cash distribution payable (or by selling a portion
of securities or other property distributable) to ADS holders that are obligated to pay those fees. The depositary may
generally refuse to provide fee-attracting services until its fees for those services are paid.
From time to time, the depositary may make payments to us to reimburse us for costs and expenses generally arising out
of establishment and maintenance of the ADS program, waive fees and expenses for services provided to us by the
depositary or share revenue from the fees collected from ADS holders. In performing its duties under the deposit
agreement, the depositary may use brokers, dealers, foreign currency dealers or other service providers that are owned by
or affiliated with the depositary and that may earn or share fees, spreads or commissions.
The depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own
account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including,
without limitation, transaction spreads, that it will retain for its own account. The revenue is based on, among other
things, the difference between the exchange rate assigned to the currency conversion made under the deposit agreement
and the rate that the depositary or its affiliate receives when buying or selling foreign currency for its own account. The
depositary makes no representation that the exchange rate used or obtained in any currency conversion under the deposit
agreement will be the most favorable rate that could be obtained at the time or that the method by which that rate will be
148 | ||
determined will be the most favorable to ADS holders, subject to the depositary’s obligations under the deposit
agreement. The methodology used to determine exchange rates used in currency conversions is available upon request.
149 | ||
PART II
ITEM 13.DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
Not applicable.
ITEM 14.MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF
PROCEEDS
On July 18, 2023, we entered into an Underwriting Agreement with J.P. Morgan Securities LLC, Morgan Stanley & Co.
LLC, Goldman Sachs & Co. LLC, BofA Securities, Inc., Cowen and Company, LLC, as representatives of the several
underwriters named therein, relating to a global offering of an aggregate of 2,244,899 ordinary shares of the Company,
nominal value €0.10 per share, including ordinary shares represented by ADSs, comprised of (i) 1,580,981 ADSs at a
public offering price of $490.00 per ADS in the U.S. and countries outside the EEA and (ii) 663,918 ordinary shares at
an offering price of €436.37 per ordinary share in a concurrent private placement in the EEA to certain legal entities all
of which are qualified investors within the meaning of Regulation 2017/1129 of the European Parliament and of the
Council of June 14, 2017, as amended. The offering was made pursuant to our effective shelf registration statement on
Form F-3ASR (File No. 333-258251) filed on July 29, 2021, as supplemented by a preliminary prospectus supplement
dated July 17, 2023, filed with the SEC on July 17, 2023, and a final prospectus supplement dated July 18, 2023, filed
with the SEC on July 20, 2023. In connection with this offering, we granted the underwriters a 30-day option to purchase
up to 336,734 additional ordinary shares (which may be represented by ADSs), which was exercised in full. The net
proceeds to us from the sale of the ADSs and ordinary shares in this offering, after deducting the underwriting discounts
and commissions and estimated offering expenses payable by the Company, was $1.2 billion (€1.1 billion). The offering
closed on July 24, 2023.
We have not used any of the net proceeds from the offering to make payments, directly or indirectly, to any director,
officer or general partner of ours or to their associates, persons owning 10% or more of any class of our equity securities,
or to any of our affiliates. We have invested the net proceeds from the offering in cash and cash equivalents and current
financial assets. There has been no material change in our planned use of the net proceeds from the offering as described
in our final prospectus supplement filed pursuant to Rule 424(b)(5) under the Securities Act with the SEC on July 20,
2023 (File No.333-258251). The registration statement was effective on July 29, 2021.
ITEM 15.CONTROLS AND PROCEDURES
A.DISCLOSURE CONTROLS AND PROCEDURES
Our management, with the participation of our CEO and CFO, has evaluated the effectiveness of the design and
operation of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b) as of December 31, 2025.
While there are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including
the possibility of human error and the circumvention or overriding of the controls and procedures, our disclosure controls
and procedures are designed to provide reasonable assurance of achieving their objectives.
Based upon our evaluation, as of December 31, 2025, our CEO and CFO have concluded that the disclosure controls and
procedures, in accordance with Exchange Act Rule 13a-15(e), are (i) effective at the level of reasonable assurance in
ensuring that information required to be disclosed in the reports that are filed or submitted under the Exchange Act, is
recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms,
and (ii) are effective at the level of reasonable assurance in ensuring that information to be disclosed in the reports that
are filed or submitted under the Exchange Act is accumulated and communicated to the management of our company,
including our CEO and CFO, to allow timely decisions regarding required disclosure.
B.MANAGEMENT’S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL
REPORTING
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as
such term is defined in Rule 13a-15(f) and Rule 15d-15(f) under the Exchange Act). Our internal control over financial
reporting is a process designed, under the supervision of our CEO and CFO, to provide reasonable assurance regarding
the reliability of financial reporting and preparation of financial statements for external reporting purposes in accordance
with IFRS, as issued by the IASB.Our internal control over financial reporting includes policies and procedures that
pertain to the maintenance of records that, in reasonable detail, accurately and fairly, reflect transactions and dispositions
of assets, provide reasonable assurance that transactions are recorded in the manner necessary to permit the preparation
of financial statements in accordance with IFRS, as issued by the IASB, and that receipts and expenditures are only
carried out in accordance with the authorization of our management and directors, and provide reasonable assurance
regarding the prevention or timely detection of any unauthorized acquisition, use or disposition of our assets that could
have a material effect on our consolidated financial statements.
150 | ||
Because of its inherent limitations, internal control over financial reporting may not prevent or detect all misstatements.
Moreover, projections of any evaluation of the effectiveness of internal control to future periods are subject to a risk that
controls may become inadequate because of changes in conditions and that the degree of compliance with the policies or
procedures may deteriorate.
Our management has assessed the effectiveness of internal control over financial reporting based on the Internal Control-
Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in
2013. Based on this assessment, our management has concluded that our internal control over financial reporting as of
December 31, 2025 was effective.
C.ATTESTATION OF THE REGISTERED PUBLIC ACCOUNTING FIRM
The effectiveness of our internal control over financial reporting as of December 31, 2025 has been audited by EY
Accountants B.V., our independent registered public accounting firm. EY Accountants B.V.’s audit report, including its
opinion on management’s assessment of internal control over financial reporting, is included in our audited consolidated
financial statements included in this Annual Report.
D.CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING
During the period covered by this Annual Report, we have not made any change to our internal control over financial
reporting that has materially affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
ITEM 16.[RESERVED]
ITEM 16.A.AUDIT COMMITTEE FINANCIAL EXPERT
Our Board of Directors previously determined that each of Peter Verhaeghe, Anthony Rosenberg, James Daly and Steve
Krognes satisfy the independence requirements set forth in Rule 10A-3 of the Exchange Act and that Mr. Krognes
qualifies as an “audit committee financial expert” as defined by SEC rules, and has the requisite financial sophistication
to meet the requirements of the Nasdaq Listing Rules.
ITEM 16.B.CODE OF ETHICS
We adopted a Code of Business Conduct and Ethics (Code of Conduct), that is applicable to all of our employees and
directors. Our Code of Conduct translates the core values into a set of clear standards to help guide our conduct as we
navigate the complexities of the highly regulated and competitive global marketplace in which we operate as we work to
become an independent, fully integrated, and global immunology company. Its purpose is not to exhaustively list all the
behaviors we as a company expect from each other. Rather, the Code of Conduct contains key principles for us to live by
as individuals, to ensure that we maximally contribute to argenx’s collective success. [As part of their onboarding, all
employees receive a training on the Code of Conduct and the Directors receive a copy of the Code of Conduct and need
to comply with its terms.] The Code of Conduct is available on our website at www.argenx.com/investors/governance/
rules-codes-compliance. The Audit and Compliance Committee of our Board of Directors (i) is responsible for
overseeing and evaluating the Code of Conduct and (ii) is required to approve any waivers of the Code of Conduct for
employees and directors. The Audit and Compliance Committee has not received requests for material waivers of the
Code of Conduct in the financial year 2025. We expect that any amendments to the Code of Conduct, and any waivers of
its requirements, will be disclosed on our website.
ITEM 16.C.PRINCIPAL ACCOUNTANT FEES AND SERVICES
EY Accountants B.V. serves as our independent registered public accounting firm as of the 2025 fiscal year. Deloitte
Accountants B.V. served as our independent registered public accounting firm for the 2024 fiscal year. Our accountants
billed the following professional fees to us in their respective years of service:
Year Ended December 31, | ||||||
Fees (in thousands of $) | 20251) | 20242) | ||||
Audit fees | $ | 2,633 | $ | 2,657 | ||
Audit-related fees | 705 | 597 | ||||
Total | $ | 3,338 | $ | 3,254 | ||
151 | ||
1)Audit services performed by EY Accountants B.V. as the external auditor in 2025 referred to in Section 1 of the Dutch Accounting Firms
Oversight Act (Wta) as well as by the EY network.. In 2025, audit and audit related fees of EY Accountants B.V. (excluding its member firms
and/or affiliates) amounted to $973 and $677, respectively.
2)Audit services performed by Deloitte Accountants B.V. as the external auditor referred to in Section 1 of the Dutch Accounting Firms Oversight
Act (Wta) as well as by the Deloitte network
“Audit fees” are the aggregate fees billed for the statutory audit of our annual financial statements, and the audit of form
20-F as filed with the SEC.
“Audit-related fees” are the aggregate fees billed for permissible other assurance services. In 2025 and 2024, “audit-
related” fees includes fees billed for the limited assurance engagement in relation to the Sustainability Statement.
No other fees were billed by EY Accountants B.V. for the years ended December 31, 2025 and 2024.
No other fees were billed by Deloitte Accountants B.V. for the year ended December 31, 2024.
Audit and Compliance Committee's Pre-Approval Policies and Procedures
Our audit and compliance committee has responsibility over, among other things, appointing, setting the compensation
of and overseeing the work of our independent registered public accounting firm, or external auditor. In recognition of
these responsibilities, our audit and compliance committee adopted a policy governing the pre-approval of all audit and
permitted non-audit services performed by our external auditor to ensure that the provision of such services does not
impair the external auditor’s independence from us and our management. Unless a type of service to be provided by our
external auditor has received general pre-approval from the audit and compliance committee, it requires specific pre-
approval by the audit and compliance committee in accordance with the pre-approval policy. Any payments proposed to
be made in connection with any proposed services that exceed pre-approved cost levels require specific pre-approval by
the audit and compliance committee.
Pursuant to the pre-approval policy, the audit and compliance committee may delegate its authority to pre-approve
services to the chairperson of the audit and compliance committee. Any decisions of the chairperson to grant pre-
approvals must be presented to the full audit and compliance committee at its next scheduled meeting. The audit and
compliance committee may not delegate its responsibilities to pre-approve services to management.
For the financial year ended December 31, 2025, the audit and compliance committee considered the non-audit services
provided by EY Accountants B.V. as described above and believes that they are compatible with maintaining EY
Accountants B.V.’s independence as our external auditor. In addition, for the financial year ended December 31, 2024,
the audit and compliance committee considered the non-audit services provided by Deloitte Accountants B.V. as
described above and believes that they are compatible with Deloitte Accountants B.V.’s independence as our external
auditor. In accordance with Regulation S-X, Rule 2-01, paragraph (c)(7)(i), no fees for services were approved pursuant
to any waivers of the pre-approval requirement.
ITEM 16.D.EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
ITEM 16.E.PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
Not applicable.
ITEM 16.F.CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Not applicable.
ITEM 16.G.CORPORATE GOVERNANCE
As a foreign private issuer, the Nasdaq Listing Rules include certain accommodations in the corporate governance
requirements that allow foreign private issuers to follow “home country” corporate governance practices in lieu of the
otherwise applicable Nasdaq corporate governance standards. We intend to rely on certain exemptions for foreign private
issuers and to follow Dutch corporate governance practices in lieu of the Nasdaq corporate governance rules.
The following is a summary of the significant ways in which our corporate governance practices differ from those
required by the Nasdaq Listing Rules with which we are not required to comply:
152 | ||
•Quorum at Shareholder Meetings. In accordance with Dutch law and generally accepted business practices in the
Netherlands, our Articles of Association do not provide quorum requirements generally applicable to general
meetings of shareholders. To that extent, our practice varies from the requirement of Nasdaq Listing Rule 5620(c),
which requires an issuer to provide in its bylaws for a generally applicable quorum, and that such quorum may not be
less than one-third of the outstanding voting stock.
•Solicitation of Proxies. Although we must provide shareholders with an agenda and other relevant documents ahead
of any General Meeting, Dutch law does not have a regulatory regime for the solicitation of proxies, and the
solicitation of proxies is not a generally accepted business practice in the Netherlands. Thus, our practice varies from
the requirement of Nasdaq Listing Rule 5620(b).
•Shareholder Approval. We follow certain Dutch shareholder approval requirements for the issuance of securities in
connection with certain events such as the acquisition of stock or assets of another company, the establishment of or
amendments to equity-based compensation plans for employees, a change of control of us and certain private
placements. To this extent, our practice varies from the requirements of Nasdaq Rule 5635, which generally requires
an issuer to obtain shareholder approval for the issuance of securities in connection with such events.
•Distribution of Annual Reports. We do not follow Nasdaq Listing Rule 5250(d), which requires companies to make
available copies of their annual reports containing audited financial statements to their shareholders. The distribution
of our annual reports to shareholders is not required under Dutch corporate law or Dutch securities laws. Furthermore,
it is generally accepted business practice for Dutch companies not to distribute annual reports. In part, this is because
the Dutch system of bearer shares has made it impractical to keep a current list of holders of the bearer shares in order
to distribute the annual reports. Instead, we make our Annual Report available at our corporate head office in the
Netherlands (and at the offices of our Dutch listing agent as stated in the convening notice for the meeting) no later
than 42 days prior to convocation of any annual General Meeting. In addition, we post a copy of our annual reports on
our website prior to our annual General Meeting.
ITEM 16.H.MINE SAFETY DISCLOSURE
Not applicable.
ITEM 16.I.DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
ITEM 16.J.INSIDER TRADING POLICIES
Our Board of Directors has adopted an insider trading policy which governs the purchase, sale, and other dispositions of
our securities by our directors, senior executives, employees and other persons engaged by the Company such as
consultants or other temporary staff that are reasonably designed to promote compliance with applicable insider trading
laws, rules, and regulations, and any listing standards applicable to the Company. Copy of our insider trading policy is
filed as Exhibit 11.1 to this Annual Report.
ITEM 16.K.CYBERSECURITY
Our approach to risk management is designed to identify, assess, prioritize and manage major risk exposures that could
affect our ability to execute our corporate strategy and fulfill our business objectives. As part of our information security
and privacy program, the Information Security and Management System (the ISMS), we perform risk assessments in
which we map and prioritize information security risks identified through the processes described below, including risks
processes and are included with other enterprise risks as part of our broader enterprise risk management. We view
information security risks as one of the key risks categories we face. IT system vendors are subject to security review
and audits. For more information regarding the cybersecurity-related risks we face, please refer to “Item 3.D. — Risk
Factors - Risk Factors Related to argenx's Business and Industry - Our business and operations could suffer in the event
across our business as part of our ISMS. Among other things, we conduct audits and tests of our information systems
(including review and assessment by independent third-party advisors, who assess and report on the maturity of our
security measures and help identify areas for continued focus and improvement) and review information security threat
153 | ||
data security matters for our employees to be aware and vigilant against potential data security risks and data privacy is
incorporated into our overall compliance training, such as through privacy-specific training for employees and
contractors. Phishing training is also implemented regularly, which includes mock phishing emails to test employee
vigilance. In addition, employees are required to read and acknowledge information security policies that are relevant to
their specific role. We also have implemented and maintain information security incident response plans, which include
processes to triage, assess severity for, escalate, contain, investigate and remediate information security incidents, as well
as to comply with potentially applicable legal obligations and mitigate brand and reputational damage.
Information Security Governance and Oversight
effectiveness of our information security risk management practices and capabilities, including the division of
responsibilities for reviewing our information security risk exposure and risk tolerance, tracking emerging information
risks and ensuring proper escalation of certain key risks for periodic review by the Board of Directors and its
also oversees our internal control over financial reporting.
results of our enterprise risk assessments, including information security risk assessments, as well as management's
strategies to detect, monitor and manage such risks and related risk assessment and risk management policies. The
Digital Technology lead for Security and Compliance provides regular updates on cyber risks, cyber security matters and
officer provides regular updates to the Senior Management Team, and the Audit and Compliance Committee as a
reports to the Global Corporate Compliance Committee, the Global Risk Management Committee and the General
Counsel and Corporate Secretary on matters such as the status of the organizational privacy plan, data breaches and
Digital Technologies reports to the Audit and Compliance Committee or the full Board of Directors, as appropriate, on
how certain information security risks are being managed and progress towards agreed mitigation goals, as well as any
potential material risks from cybersecurity threats that have been detected by the information security team.
Our information security team is responsible for day-to-day identification, assessment and management of the
information security risks we face. Our Global Head of Digital Technologies has almost 25 years33 years of experience
in information management systems in life sciences and the managers reporting to the Global Head of Digital
breach procedures seek to promote the timely detection, reporting, and investigation of all security incidents, as well as
the timely notification of any reportable breaches (including any material cybersecurity incidents and personal data
breaches) to the competent authorities and the timely communication to the affected individuals, where relevant. We
maintain records of breaches on our quarterly corporate risk dashboard and our personal data breach register, and we
monitor and regularly report our data breach metrics to the Senior Management Team, including the Audit and
Compliance Committee, the global corporate compliance committee, and the global risk management committee. In
addition to the ordinary-course Board of Directors and Audit and Compliance Committee reporting and oversight
described above, we also maintain disclosure controls and procedures designed for prompt reporting to the Board of
Directors and timely public disclosure, as appropriate, of material events, including information security risks.
154 | ||
PART III
ITEM 17.FINANCIAL STATEMENTS
Not applicable.
ITEM 18.FINANCIAL STATEMENTS
ITEM 19.EXHIBITS
The exhibits listed in the Exhibit Index at the end of this Annual Report are filed as exhibits to this Annual Report.
Incorporated by Reference | ||||||||||
Exhibit | Description | Schedule/ Form | File Number | Exhibit | File Date (mm/dd/yyyy) | |||||
1.1 | Form 20-F | 001-38097 | 1.1 | 03/20/2025 | ||||||
1.2# | ||||||||||
2.1 | Form F-1/A | 333-217417 | 4.1 | 05/16/2017 | ||||||
2.2 | Form F-1/A | 333-217417 | 4.1 | 05/16/2017 | ||||||
2.3# | ||||||||||
4.1** | Form F-1 | 333-217417 | 10.2 | 04/21/2017 | ||||||
4.2† | Form F-1 | 333-217417 | 10.3 | 04/21/2017 | ||||||
4.3#† | ||||||||||
4.4 | Form 20-F | 001-38097 | 4.7 | 03/30/2021 | ||||||
4.5#† | ||||||||||
8.1 | Form 20-F | 001-38097 | 8.1 | 03/16/2023 | ||||||
11.1# | ||||||||||
12.1# | ||||||||||
12.2# | ||||||||||
155 | ||
13.1* | ||||||||||
13.2* | ||||||||||
15.1# | ||||||||||
15.2# | ||||||||||
97.1 | Form 20-F | 001-38097 | 97.1 | 03/21/2024 | ||||||
101.INS # | Inline XBRL Instance Document | |||||||||
101.SCH # | Inline XBRL Taxonomy Extension Schema Document | |||||||||
101.CAL # | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||
101.DEF # | Inline XBRL Taxonomy Extension Definition Linkbase Document | |||||||||
101.LAB # | Inline XBRL Taxonomy Extension Label Linkbase Document | |||||||||
101.PRE # | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
# | Filed herewith. |
* | Furnished herewith. |
† | Indicates a management contract or any compensatory plan, contract or arrangement. |
** | Confidential treatment status has been granted as to certain portions thereto, which portions are omitted and filed separately with the U.S. Securities and Exchange Commission. |
156 | ||
SIGNATURES
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly
caused and authorized the undersigned to sign this Annual Report on its behalf.
Date: March 19, 2026
ARGENX SE | |||
By: | /s/ Tim Van Hauwermeiren | ||
Name: | Tim Van Hauwermeiren | ||
Title: | Chief Executive Officer | ||
F-1 |
INDEX TO FINANCIAL STATEMENTS
Audited consolidated financial statements as of and for the years ended December 31, 2025, 2024 and 2023 | |
F-5 | |
F-2 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and the Board of Directors of argenx SE
Opinion on the Financial Statements
We have audited the accompanying consolidated statement of financial position of argenx SE (the Company) as of
December 31, 2025, the related consolidated statements of profit or loss, comprehensive income or loss, changes in
equity and cash flows for the year then ended, and the related notes (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the
financial position of the Company at December 31, 2025, and the results of its operations and its cash flows for the year
then ended in conformity with IFRS Accounting Standards as issued by the International Accounting Standards Board.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2025, based on criteria
established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (2013 framework) and our report dated March 19, 2026 expressed an unqualified opinion
thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an
opinion on the Company’s financial statements based on our audit. We are a public accounting firm registered with the
PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial statements are free of material
misstatement, whether due to error or fraud. Our audit included performing procedures to assess the risks of material
misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those
risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the financial statements. We believe that our audit
provides a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements
that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or
disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or
complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the
consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below,
providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
U.S. Sales Rebates and Reserves – Medicare Part D Claims
Description of the Matter
As described in “Note 2.17 – Product Net Sales, “Note 3 – Critical Accounting Judgments,” and “Note 14 – Trade and
Other Payables” to the consolidated financial statements, the Company recognizes revenue net of price reductions,
including, among others, estimates of Medicare Part D Manufacturer Discount Program claims and also recognizes an
accrued liability, in sales rebates and reserves, for the estimated claims amount. These claim estimates are based on the
expected value method, taking into account the payor mix. At December 31, 2025, the Company had $402 million in
liabilities related to sales rebates and reserves.
Auditing sales rebates and reserves related to Medicare Part D was complex and subjective as it required auditor
judgment about the payor mix assumption used in determining the estimated claims amount.
F-3 |
How We Addressed the Matter in Our Audit
We tested the Company’s internal controls over the Medicare Part D sales rebates and reserves process. This included
testing controls over the data used to determine the payor mix, management's review of the expected-value method
model and the payor mix assumption, and the comparison of actual claim payments to the estimated claims amount.
Our audit procedures to test Medicare Part D sales rebates and reserves included, among others, independently
developing an estimate of the claims amount and testing the mathematical accuracy of the model used by management.
We assessed the reasonableness of the Company's estimated Medicare Part D claims amount by comparing previous
estimates to actual claims and agreeing a sample of those claims to source documents. We assessed the adequacy of
Company’s disclosures related to Medicare Part D sales rebates and reserves.
/s/ EY Accountants B.V.
We have served as the Company's auditor since 2024.
Eindhoven, the Netherlands
March 19, 2026
F-4 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of argenx SE
Opinion on Internal Control over Financial Reporting
We have audited argenx SE and subsidiaries’ internal control over financial reporting as of December 31, 2025, based on
criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission 2013 framework (the COSO criteria). In our opinion, argenx SE and subsidiaries (the
Company) maintained, in all material respects, effective internal control over financial reporting as of December 31,
2025, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States) (PCAOB), the 2025 consolidated financial statements of the Company and our report dated March 19, 2026
expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s
Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the
Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with
the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a
material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the
assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that
our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles. A company’s internal control over financial reporting includes those policies
and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of
management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may
deteriorate.
/s/ EY Accountants B.V.
March 19, 2026
F-5 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and the Board of Directors of argenx SE
Opinion on the Financial Statements
We have audited the accompanying consolidated statements of financial position of argenx SE and subsidiaries (the
“Company”) as of December 31, 2024 and 2023, the related consolidated statements of profit or loss, comprehensive
income or loss, cash flows, and changes in equity, for each of the two years in the period ended December 31, 2024, and
the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present
fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results
of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with
IFRS® Accounting Standards (IFRS), issued by the International Accounting Standards Board (IASB).
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an
opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the
PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial statements are free of material
misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material
misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those
risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
financial statements. Our audits also included evaluating the accounting principles used and significant estimates made
by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
/s/ Deloitte Accountants B.V.
Rotterdam, The Netherlands
March 20, 2025
We began serving as the Company’s auditor in 2015. In 2025 we became the predecessor auditor.
F-6 |
ARGENX SE
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
As of December 31, | |||||||||||
(in thousands of $) | Note | 2025 | 2024 | 2023 | |||||||
Assets | |||||||||||
Non‑current assets | |||||||||||
Property, plant and equipment | 4 | $ | $ | $ | |||||||
Intangible assets | 5 | ||||||||||
Deferred tax assets | 22 | ||||||||||
Research and development incentive receivables | |||||||||||
Investment in a joint venture | 25 | ||||||||||
Prepaid expenses | |||||||||||
Other non-current assets | 6 | ||||||||||
Total non‑current assets | |||||||||||
Current assets | |||||||||||
Inventories | 7 | $ | $ | $ | |||||||
Prepaid expenses | 8 | ||||||||||
Trade and other receivables | 9 | ||||||||||
Research and development incentive receivables | |||||||||||
Financial assets | 10 | ||||||||||
Cash and cash equivalents | 11 | ||||||||||
Total current assets | |||||||||||
Total assets | $ | $ | $ | ||||||||
The accompanying notes form an integral part of these consolidated financial statements.
F-7 |
As of December 31, | ||||||||||||
(in thousands of $) | Note | 2025 | 2024 | 2023 | ||||||||
Equity and liabilities | ||||||||||||
Equity | 12 | |||||||||||
Equity attributable to owners of the parent | ||||||||||||
Share capital | $ | $ | $ | |||||||||
Share premium | ||||||||||||
Translation differences | ||||||||||||
Accumulated losses | ( | ( | ( | |||||||||
Other reserves | ||||||||||||
Total equity | $ | $ | $ | |||||||||
Non-current liabilities | ||||||||||||
Provisions for employee benefits | ||||||||||||
Lease liabilities | 20 | |||||||||||
Deferred tax liabilities | 22 | |||||||||||
Total non-current liabilities | ||||||||||||
Current liabilities | ||||||||||||
Lease liabilities | 20 | |||||||||||
Trade and other payables | 14 | |||||||||||
Tax liabilities | 22 | |||||||||||
Total current liabilities | ||||||||||||
Total liabilities | $ | $ | $ | |||||||||
Total equity and liabilities | $ | $ | $ | |||||||||
The accompanying notes form an integral part of these consolidated financial statements.
F-8 |
ARGENX SE
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
Year Ended December 31, | |||||||||||
(in thousands of $ except for shares and EPS) | Note | 2025 | 2024 | 2023 | |||||||
Product net sales | 16 | $ | $ | $ | |||||||
Other operating income1) | 15 | ||||||||||
Total operating income | |||||||||||
Cost of sales | 7 | ( | ( | ( | |||||||
Research and development expenses | 17 | ( | ( | ( | |||||||
Selling, general and administrative expenses | 18 | ( | ( | ( | |||||||
Loss from investment in a joint venture | 25 | ( | ( | ( | |||||||
Total operating expenses | ( | ( | ( | ||||||||
Operating profit/(loss) | $ | $ | ( | $ | ( | ||||||
Financial income | |||||||||||
Financial expense | ( | ( | ( | ||||||||
Exchange gains/(losses) | 21 | ( | |||||||||
Profit/(Loss) for the year before taxes | $ | $ | $ | ( | |||||||
Income tax benefit | 22 | $ | $ | $ | |||||||
Profit/(Loss) for the year | $ | $ | $ | ( | |||||||
Profit/(Loss) for the year attributable to: | |||||||||||
Owners of the parent | ( | ||||||||||
Weighted average number of shares used for basic profit/(loss) per share | 23 | ||||||||||
Basic profit/(loss) per share (in $) | 23 | ( | |||||||||
Weighted average number of shares used for diluted profit/(loss) per share | 23 | ||||||||||
Diluted profit/(loss) per share (in $) | 23 | ( | |||||||||
and other operating income.
The accompanying notes form an integral part of these consolidated financial statements.
F-9 |
ARGENX SE
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME OR LOSS
Year Ended December 31, | |||||||||||
(in thousands of $) | Note | 2025 | 2024 | 2023 | |||||||
Profit/(Loss) for the year | $ | $ | $ | ( | |||||||
Items that may be reclassified subsequently to profit or loss, net of tax | |||||||||||
Currency translation differences, arisen from translating foreign activities | ( | ||||||||||
Items that will not be reclassified subsequently to profit or loss, net of tax | |||||||||||
Fair value (loss)/gain on investments in equity instruments designated as FVTOCI | 6 | ( | ( | ( | |||||||
Other comprehensive profit/(loss), net of income tax | ( | ||||||||||
Total comprehensive profit/(loss) attributable to: | |||||||||||
Owners of the parent | $ | $ | $ | ( | |||||||
The accompanying notes form an integral part of these consolidated financial statements.
F-10 |
ARGENX SE
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended December 31, | |||||||||||
(in thousands of $) | Note | 2025 | 20241) | 20231) | |||||||
Operating profit/(loss) | $ | $ | ( | $ | ( | ||||||
Adjustments for non-cash items | |||||||||||
Amortization of intangible assets | 5 | ||||||||||
Depreciation of property, plant and equipment | 4 | ||||||||||
Provisions for employee benefits | |||||||||||
Expense recognized in respect of share-based payments | 13 | ||||||||||
Fair value gains on financial assets at fair value through profit or loss | 6 | ( | ( | ||||||||
Loss from investment in a joint venture | 25 | ||||||||||
Other non-cash expenses/(benefit) | ( | ||||||||||
$ | $ | $ | ( | ||||||||
Movements in current assets/liabilities | |||||||||||
(Increase)/decrease in trade and other receivables | 9 | ( | ( | ( | |||||||
(Increase)/decrease in inventories | 7 | ( | ( | ( | |||||||
(Increase)/decrease in current prepaid expenses | 8 | ( | ( | ( | |||||||
(Increase)/decrease in other current assets | ( | ( | ( | ||||||||
Increase/(decrease) in trade and other payables | 14 | ||||||||||
Movements in non-current assets/liabilities | |||||||||||
(Increase)/decrease in other non‑current assets | 6 | ( | ( | ||||||||
(Increase)/decrease in non-current prepaid expense | ( | ( | |||||||||
Net cash flows from/(used) in operating activities, before interest and taxes | ( | ( | |||||||||
Interest paid | ( | ( | ( | ||||||||
Income taxes (paid)/received | 22 | ( | ( | ||||||||
Net cash flows from/(used) in operating activities | $ | $ | ( | $ | ( | ||||||
Purchase of intangible assets | 5 | ( | ( | ( | |||||||
Purchase of property, plant and equipment | 4 | ( | ( | ( | |||||||
Purchase of current financial assets | 10 | ( | ( | ( | |||||||
Sale of current financial assets | 10 | ||||||||||
Interest received | |||||||||||
Investment in a joint venture | 25 | ( | ( | ( | |||||||
Net cash flows from/(used in) investing activities | $ | $ | ( | $ | |||||||
Principal elements of lease payments | 20 | ( | ( | ( | |||||||
Proceeds from issue of new shares, gross amount | 12 | ||||||||||
Issue costs paid | 12 | ( | |||||||||
Exchange (losses)/gains from currency conversion on proceeds from issue of new shares | ( | ||||||||||
Payment of employee withholding taxes relating to restricted stock unit awards | ( | ( | ( | ||||||||
Proceeds from exercise of stock options | 12 | ||||||||||
Net cash flows from financing activities | $ | $ | $ | ||||||||
F-11 |
Year Ended December 31, | |||||||||||
(in thousands of $) | Note | 2025 | 20241) | 20231) | |||||||
Increase/(decrease) in cash and cash equivalents | $ | $ | $( | $ | |||||||
Cash and cash equivalents at the beginning of the year | $ | $ | $ | ||||||||
Exchange gains/(losses) on cash and cash equivalents | $ | $ | ( | $ | |||||||
Cash and cash equivalents at the end of the year | $ | $ | $ | ||||||||
The accompanying notes form an integral part of these consolidated financial statements.
F-12 |
ARGENX SE
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(in thousands of $) | Attributable to owners of the parent | ||||||||||||||||||||||
(in thousands of $) | Share capital | Share premium | Accumulated losses | Translation differences | Share-based payment and income tax deduction on share- based payments | Fair value movement on investment in equity instruments designated as at FVTOCI | Total equity attributable to owners of the parent | Total equity | |||||||||||||||
Balance on January 1, 2023 | $ | $ | $ | ( | $ | $ | $ | ( | $ | $ | |||||||||||||
Loss for the year | ( | ( | ( | ||||||||||||||||||||
Other comprehensive income/(loss) | ( | ||||||||||||||||||||||
Total comprehensive income/(loss) for the year | ( | ( | ( | ( | |||||||||||||||||||
Income tax benefit from excess tax deductions related to share-based payments | |||||||||||||||||||||||
Share-based payment | |||||||||||||||||||||||
Issue of share capital | |||||||||||||||||||||||
Transaction costs for equity issue | ( | ( | ( | ||||||||||||||||||||
Exercise of stock options | |||||||||||||||||||||||
Ordinary shares withheld for payment of employees’ withholding tax liability | ( | ( | ( | ||||||||||||||||||||
Balance on December 31, 2023 | $ | $ | $ | ( | $ | $ | $ | ( | $ | $ | |||||||||||||
Profit for the year | |||||||||||||||||||||||
Other comprehensive loss | ( | ( | ( | ( | |||||||||||||||||||
Total comprehensive income/(loss) for the year | ( | ( | |||||||||||||||||||||
Income tax benefit from excess tax deductions related to share-based payments | |||||||||||||||||||||||
Share-based payment | |||||||||||||||||||||||
Exercise of stock options | |||||||||||||||||||||||
Ordinary shares withheld for payment of employees’ withholding tax liability | ( | ( | ( | ||||||||||||||||||||
Balance on December 31, 2024 | $ | $ | $ | ( | $ | $ | $ | ( | $ | $ | |||||||||||||
Profit for the year | |||||||||||||||||||||||
Other comprehensive income/(loss) | ( | ||||||||||||||||||||||
Total comprehensive income/(loss) for the year | ( | ||||||||||||||||||||||
Income tax benefit from excess tax deductions related to share-based payments | |||||||||||||||||||||||
Share-based payment | |||||||||||||||||||||||
Exercise of stock options | |||||||||||||||||||||||
Ordinary shares withheld for payment of employees’ withholding tax liability | ( | ( | ( | ||||||||||||||||||||
Balance on December 31, 2025 | $ | $ | $ | ( | $ | $ | $ | ( | $ | $ | |||||||||||||
Please refer to ‘‘Note 12 — Share Capital and Share Premium’’ for more information on the share capital and movement in number of shares. See also ‘‘Note 13 — Share-Based
Payments’’ for more information on the share-based payments. The accompanying notes form an integral part of these consolidated financial statements.
F-13 |
ARGENX SE
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
argenx SE is a Dutch European public company with limited liability incorporated under the laws of the Netherlands.
The company (COC 24435214) has its official seat in Amsterdam, the Netherlands, and its registered office is at
Laarderhoogtweg 25, 1101 EB Amsterdam, the Netherlands. An overview of the company and its subsidiaries (the
Company) are described in ‘‘Note 29 — Overview of Consolidation Scope’’.
argenx SE is a publicly traded company with ordinary shares listed on Euronext Brussels under the symbol “ARGX”
The Company’s material accounting policies are summarized below.
The consolidated financial statements are prepared in accordance with the IFRS® Accounting Standards (IFRS) as issued
by the International Accounting Standards Board (IASB). The consolidated financial statements provide a general
overview of the Company’s activities and the results achieved. They present fairly the entity’s financial position, its
financial performance and cash flows, on a going concern basis.
The material accounting policy information applied in the preparation of the above consolidated financial statements are
set out below. All amounts are presented in thousands of US dollar, unless otherwise indicated, rounded to the nearest $
‘000.
The consolidated financial statements have been approved for issue by the Company’s Board of Directors (the “Board”)
on March 18, 2026.
•In the current year, the Group has assessed and adopted amendments to IFRS as issued by the IASB that are
mandatorily effective for accounting periods that begin on or after January 1, 2025. Their adoption has not had any
material impact on the disclosures or on the amounts reported in these consolidated financial statements.
•IFRS 18 Presentation and Disclosures in Financial Statements
IFRS 18 replaces IAS 1, carrying forward many of the requirements in IAS 1 unchanged and complementing them with
new requirements. In addition, some IAS 1 paragraphs have been moved to IAS 8 Accounting Policies, Changes in
Accounting Estimates and Errors and IFRS 7 Financial Instruments: Disclosures. Furthermore, the IASB has made
minor amendments to IAS 7 Statement of Cash Flows and IAS 33 Earnings per Share.
IFRS 18 introduces new requirements to:
•present specified categories and defined subtotals in the statement of profit or loss
•provide disclosures on management-defined performance measures (MPMs) in the notes to the financial statements
•improve aggregation and disaggregation.
An entity is required to apply IFRS 18 for annual reporting periods beginning on or after January 1, 2027, with earlier
application permitted. The amendments to IAS 7 and IAS 33, as well as the revised IAS 8 and IFRS 7, become effective
when an entity applies IFRS 18. IFRS 18 requires retrospective application with specific transition provisions.
F-14 |
The Company is currently working to identify all impacts the new standard and amendments will have on the primary
financial statements and notes to the financial statements. The initial expected material impact on the Company’s
financial statements is, as follows:
•Foreign exchange differences will be classified in the same category as the income and expenses from the items
giving rising to the foreign exchange differences.
•Amendments to the Classification and Measurement of Financial Instruments (Amendments to IFRS 9 and IFRS 7)
The amendments address matters identified during the post-implementation review of the classification and measurement
requirements of IFRS 9 Financial Instruments. The amendments are effective for annual periods starting on or after 1
January 2026.
The Company does not anticipate that the amendments will have a material effect on the Company’s financial statements
in future periods.
We have not early adopted any standard, interpretation, or amendment that has been issued but is not yet effective.
The consolidated financial statements include the financial statements of the Company and entities controlled by the
Company (its subsidiaries). Control is achieved when the Company:
•has power over the investee;
•is exposed, or has rights, to variable returns from its involvement with the investee; and
•has the ability to use its power to affect its returns.
The Company reassesses whether or not it controls an investee if facts and circumstances indicate that there are changes
to one or more of the three elements of control listed above.
The results of the subsidiaries are included in the consolidated statements of profit or loss and consolidated statements of
other comprehensive income or loss from the effective date of acquisition up to the date when control ceases to exist.
When necessary, adjustments are made to the financial statements of subsidiaries to bring their accounting policies into
line with those used by other members of the Group.
All intercompany transactions and unrealized gains on transactions between group companies are eliminated. Unrealized
Items included in the consolidated financial statements of each of the entities are valued using the currency of their
economic environment in which the entity operates. The consolidated financial statements are presented in USD ($),
which is the Company’s functional and presentation currency.
Transactions in foreign currencies are translated at the exchange rate ruling at the date of the transaction. Monetary
assets and liabilities denominated in foreign currencies are translated at the exchange rate ruling at the reporting date.
Foreign exchange differences arising on translation are recognized in the consolidated statements of profit or loss and the
consolidated statements of other comprehensive income or loss as “Exchange (losses)/gains”. Non-monetary assets and
liabilities denominated in foreign currencies are translated at the foreign exchange rate applicable at the date of the
transaction.
F-15 |
For foreign entities using a different functional currency than USD:
•assets and liabilities for each balance sheet presented are translated at the closing rate at the date of the balance sheet;
•income and expenses for each statement presenting profit or loss and statements of other comprehensive income or
loss are translated at average exchange rates.
Expenditure on research activities is recognized as an expense in the period in which it is incurred.
Upfront payments and development milestone payments for “Acquired In-Process R&D” obtained through in-licensing
arrangements are capitalized as intangible assets under “Acquired In-Process R&D” upon meeting the IAS 38
capitalization criteria. These intangibles are considered as intangible assets with definite useful lives and are carried at
cost less amortization and accumulated impairment losses. The Company has not started to amortize “Acquired In-
Process R&D” as they are not available for use until regulatory approval has been obtained or the asset is ready for its
intended use, but they are evaluated for potential impairment on an annual basis or when facts and circumstances may
indicate a risk of impairment. Any impairment charge is recorded in the consolidated statements of profit or loss and the
consolidated statements of other comprehensive income or loss under “Research and development expense”. Once an
asset included in “Acquired In-Process R&D” has received marketing approval from a regulatory authority or is ready
for its intended use, it is recorded under “Acquired R&D available for use” category.
Regulatory milestone payments and sales-based milestone payments for R&D obtained through in-licensing
arrangements acquired are capitalized intangible assets under “Acquired R&D available for use” upon meeting the IAS
38 capitalization criteria. All intangibles classified under “Acquired R&D available for use” are considered as intangible
assets with finite useful lives and are carried at cost less accumulated amortization and accumulated impairment losses.
“Acquired R&D available for use” is evaluated for potential impairment when the Company identifies indications based
on facts and circumstances of the asset. Any impairment charge is recorded in the consolidated statements of profit or
loss and the consolidated statements of other comprehensive income or loss under “Cost of sales” for assets which are
currently generating product net sales. “Acquired R&D available for use” is amortized under “Cost of sales” for assets
which are currently generating product net sales on a straight-line basis over the estimated useful life, being the longer of
the current patent protection life of the acquired R&D and patent protection life of the combined product. Impairment
and amortization relating to assets available for use but not generating sales are recorded under “Research &
Development Expenses”.
The current and non-current research and development incentive receivables relate to refunds resulting from research and
development incentives on Research and development expenses in Belgium and are credited to the consolidated
statements of profit or loss and the consolidated statements of other comprehensive income or loss under the line “Other
operating income” when the relevant expenditure has been incurred and there is a reasonable assurance that the research
and development incentives will be received.
Inventories are valued at the lower of cost and net realizable value. Costs incurred in bringing each product to its present
location and condition are accounted for, and include purchase cost, cost of direct materials and labor, and a proportion
of manufacturing overheads based on the normal operating capacity. Net realizable value is the estimated selling price in
the ordinary course of business, less estimated costs of completion and the estimated costs necessary to make the sale.
When the net realizable value falls below the carrying amount, or when inventories become obsolete or excessive, a
write-down is recognized.
Inventories include products which could be used, besides in commercial activities, in preclinical and clinical programs,
in free-of-charge, compassionate use or pre-approval access program. These products, when they are used, are expensed
either through “Research & development expenses” or “Selling, general and administrative expenses”.
F-16 |
The Company capitalizes inventory costs associated with products prior to the regulatory approval of these products, or
for inventory produced in production facilities not yet approved, when it is highly probable that the pre-approval
inventories will be sellable. The determination to capitalize is based on the particular facts and circumstances relating to
the expected regulatory approval of the product or production facility being considered. The assessment of whether or
not the product is considered highly probable to be sellable is made and includes, but is not limited to, how far a
particular product or facility has progressed along the approval process, any known safety or efficacy concern and other
impediments.
Capitalized costs related to pre-launch inventories could be written down upon a change in facts and circumstances. The
write-down would be recorded under “Research and development expenses” in the consolidated statements of profit or
loss and the consolidated statements of other comprehensive income or loss.
Trade and other receivables are designated as financial assets measured at amortized cost. They are initially measured
either at their invoiced amounts or at transaction price, in the absence of a significant financing component less
adjustments for estimated revenue deductions such as rebates, chargebacks and returns. All receivables are subsequently
measured at amortized cost, which generally corresponds to nominal value less expected credit loss provision.
Loss allowance for expected credit losses are established using a simplified approach of forward-looking expected credit
loss model (ECL), which includes possible default events on the trade receivables over the entire holding period of the
trade receivable. These provisions represent the difference between the trade receivable’s carrying amount in the
consolidated statements of financial position and the estimated collectible amount. Charges for loss allowance for
expected credit losses are recorded under “Selling, general and administrative expenses” in the consolidated statements
of profit or loss and consolidated statements of other comprehensive income or loss.
Current financial assets measured at amortized costs comprise of term accounts that have an initial maturity equal or less
than twelve months, but exceeding three months.
Current financial assets measured at fair value through profit or loss comprise of money market funds.
Interests on Current financial assets are reported under Cash Flow from investment activities under “Interest received”
and under “Financial income’’ in the Consolidated Statement of Profit or Loss.
Cash are financial assets measured at amortized cost and comprise of cash at bank.
Cash equivalents measured at amortized cost comprise of term accounts that have an initial maturity of less than three
months that are subject to an insignificant risk of changes in values.
Cash equivalents are determined at inception and measured at fair value through profit or loss comprise of money market
funds that are readily convertible to cash. They are subject to insignificant risk of changes in value and which are used
by the Company in the management of its short-term commitments.
Cash and cash equivalents exclude restricted cash, which is presented in the consolidated statements of financial position
under the line “Other non-current assets”.
Interests on Cash and cash equivalents is reported under Cash Flow from investment activities under “Interest received”
and under “Financial income’’ in the Consolidated Statement of Profit or Loss.
Trade and other payables are comprised of liabilities that are due less than one year from the balance sheet date and are
in general not interest bearing and settled on an ongoing basis during the financial year. They also include accrued
expenses related to the Company’s operating activities. Trade and other payables are initially measured at their
transaction price, which are subsequent to initial recognition measured at amortized cost.
Short-term employee benefits include payables and accruals for salaries and bonuses to be paid to the employees of the
Company. They are recognized as expenses for the period in which employees perform the corresponding services.
F-17 |
The Company assesses at contract inception whether a contract is, or contains, a lease. That is, if the contract conveys
the right to control the use of an identified asset for a period of time in exchange for consideration.
The Company applies a single recognition and measurement approach for all leases, except for short-term leases and
leases of low-value assets. The Company recognizes lease liabilities to make lease payments and right-of-use assets
representing the right to use the underlying assets.
The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is
available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses,
and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease
liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any
lease incentives received. Right-of-use assets are depreciated on a straight-line basis over the shorter of the lease term
and the estimated useful lives of the assets, as follows:
•Buildings2 to 15 years
•Vehicles2 to 4 years
•Equipment2 to 5 years
If ownership of the leased asset transfers to the Company at the end of the lease term or the cost reflects the exercise of a
purchase option, depreciation is calculated using the estimated useful life of the asset.
The Company’s right-of-use assets are included in “Property, Plant and Equipment”.
At the commencement date of the lease, the Company recognizes lease liabilities measured at the present value of lease
payments to be made over the lease term. The lease payments include fixed payments, and payments of penalties for
terminating the lease, if the lease term reflects the Company exercising the option to terminate.
In calculating the present value of of lease payments, the Company uses its incremental borrowing rate at the lease
commencement date if the interest rate implicit in the lease is not readily determinable. After the commencement date,
the amount of lease liabilities is reduced for the lease payments made. In addition, the carrying amount of lease liabilities
is remeasured if there is a modification, a change in the lease term, a change in the lease payments, or a change in the
assessment of an option to purchase the underlying asset.
The Company’s lease liabilities are included in “Lease Liabilities Non-Current” and “Lease Liabilities Current”.
The Company applies the short-term lease recognition exemption (i.e., those leases that have a lease term of 12 months
or less from the commencement date and do not contain a purchase option) and the lease of low-value assets recognition
exemption to leases that are considered to be of low value. Lease payments on short-term leases and leases of low-value
assets are recognized as expense within the operating category in the statement of profit or loss, on a straight-line basis
over the lease term.
Financial instruments are initially recognized either at fair value or at transaction price and subsequently measured at
either amortized cost or fair value under IFRS 9 on the basis of both the Company’s model for managing the financial
assets and the contractual cash flow characteristics of the financial asset. A financial asset is classified as current when
the cash flows expected to flow from the instrument mature within one year.
Profit share in AgomAb Therapeutics NV: The Company holds investments in non-current financial assets, which based
on IFRS 9, are designated as financial assets at fair value through profit or loss. The fair value of listed investments is
based upon the closing price of such securities at each reporting date. As there is no active market for this equity
instrument, the Company establishes the fair value by using valuation techniques. The changes to the fair valuation is
recorded under “Other operating income” in the consolidated statements of profit or loss.
Shares of Zai Lab Ltd: Based on IFRS 9, the Company irrevocably elected to designate this specific investment as a
financial asset at fair value through OCI as the participation is not held for trading purposes nor contingent consideration
recognized by an acquirer in a business combination. The investment is recorded under “Other non-current assets” in
consolidated statements of financial position and changes to the fair valuation is recorded under “Fair value gain/(loss)
on investments in equity instruments designated as at FVTOCI” in the consolidated statements of other comprehensive
income or loss.
F-18 |
An equity instrument is any contract that evidences a residual interest in the assets of an entity after deducting all of its
liabilities. Equity instruments issued by the Company are recognized at the proceeds received, net of direct issue costs.
The Company has never distributed any dividends to its shareholders. As of December 31, 2025, no profits were
Equity-settled share-based payments to employees and others providing similar services are measured at the fair value of
the equity instruments at the acceptance date. Equity settled share-based payments includes expenses related to stock
options, restricted stock units and performance stock units granted by the Company.
The fair value determined at the acceptance date of the equity-settled share-based payments is expensed over the vesting
period, based on the Company’s estimate of equity instruments that will eventually vest, with a corresponding increase
in equity. At the end of each reporting period, the Company revises its estimate of the number of equity instruments
expected to vest. The impact of the revision of the original estimates, if any, is recognized in the consolidated statements
of profit or loss and the consolidated statements of other comprehensive income or loss such that the cumulative expense
reflects the revised estimate, with a corresponding adjustment to the equity-settled share-based payment reserve.
The share-based payment expense is recorded in the “Consolidated Statements of Profit or Loss” depending on the
nature of the services provided by each beneficiary.
Income tax in the consolidated statements of profit or loss and the consolidated statements of other comprehensive
income or loss represents the total of the current tax and deferred tax.
The current tax is based on taxable profit for the year. Taxable profit differs from profit as reported in the consolidated
statements of profit or loss and consolidated statements of other comprehensive income or loss as it excludes items of
income or expense that are taxable or deductible in other years and items that are never taxable or deductible. The
Company’s liability for current tax is calculated using tax rates that have been enacted or substantively enacted by the
end of the reporting period.
Deferred tax is recognized on temporary differences between the carrying amounts of assets and liabilities in the
consolidated financial statements and the corresponding tax basis used in the computation of taxable profit. The
Company recognizes deferred tax assets, including the tax base of tax loss carryforwards, if management assesses that
these tax assets can be offset against positive taxable profits in the future. This judgment is made on an ongoing basis,
considering actual results, budgets, and business plans for the coming years. The realization of deferred tax assets
depends on all available factors as of reporting date.
The carrying amount of deferred tax assets is reviewed at the end of each reporting period and reduced to the extent that
it is not probable that sufficient taxable profits will be available to allow all or part of the asset to be recovered. Deferred
tax assets and liabilities are offset if there is a legally enforceable right and intention to offset the income taxes and
relates to same tax jurisdiction.
Deferred tax assets and liabilities are measured at the tax rates that are expected to apply in the period in which the
liability is settled or the asset realized, based on tax rates (and tax laws) that have been enacted or substantially enacted
by the end of the reporting period.
The Company records uncertain tax positions in accordance with IAS 12 Income Taxes using the two-step test whereby
(1) the Company determines whether it is probable that the tax positions will be accepted by relevant taxing authorities,
and (2) for those tax positions that are not probable that a tax authority will accept in full the position, the Company
recognizes uncertain tax positions using either the most likely amount or the expected value, depending on specific facts
and circumstances.
Revenue from the sale of products is recognized at an amount that reflects the consideration that the Company expects to
be entitled to receive in exchange for transferring goods to a customer, at the time when the customer obtains control of
the goods rendered. The consideration that is committed in a contract with a customer can include fixed amounts,
F-19 |
variable amounts, or both. The amount of the consideration may vary due to discounts, rebates, returns, chargebacks or
other similar items. Contingent consideration is included in the transaction price when it is highly probable that the
amount of revenue recognized is not subject to significant future reversals.
Product net sales are recognized once we satisfy the performance obligation at a point in time under the revenue
recognition criteria in accordance with IFRS 15 Revenue from contracts with customers.
Revenue arising from the sale of commercial product is presented in the consolidated statements of profit or loss and the
consolidated statements of other comprehensive income or loss under “Product net sales”. In accordance with IFRS 15,
such revenue is recognized when the product is transferred, in accordance with the delivery and acceptance terms agreed
with the customer. Payment of the transaction price is payable as from the point the customer obtains the legal title to the
goods. A deferred revenue is recognized if the Company receives consideration, or has an unconditional right to receive
revenue, prior to the completion of all performance obligation.
The amount of revenue recognized reflects the various types of price reductions or rights of return offered by the
Company to its customers. Such price reductions and rights of return qualify as variable consideration under IFRS 15.
Products sold are covered by various Government and State programs for which specific discounts are applied. Rebates
are granted to healthcare authorities, and under contractual arrangements with certain customers. Some wholesalers are
entitled to chargeback incentives based on the selling price to the end customer, under specific contractual arrangements.
Rebates, chargebacks and other incentives are recognized in the period in which the underlying sales are recognized as a
reduction of product sales.
The significant components of variable consideration are as follows:
Rebates & Discounts: We are subject to government mandated rebates & discounts in multiple jurisdictions globally
including in the U.S. for Medicaid Drug Rebate Program, Medicare Part D Manufacturer Discount Program, and other
government health care programs. Rebate amounts are based upon contractual agreements and/or legal requirements with
public sector benefit providers. We use the expected-value method for estimating these rebates.
The structure of the Medicare Part D Manufacturer Discount Program was updated to reflect provisions of the Inflation
Reduction Act of 2022 (IRA) that became effective January 1, 2025. The Part D redesign sunset the Coverage Gap
Discount Program (CGDP) and established the Manufacturer Discount Program. The Medicare Part D Manufacturer
Discount Program is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the U.S.,
which mandates manufacturers to fund a portion of the Medicare Part D coverage for prescription drugs sold to eligible
patients.
The expected utilization is estimated based on available third-party data and/or historical data. Estimates for these
rebates and discounts are adjusted quarterly to reflect the most recent information. We record an accrued liability and
reduction of product sales for unpaid rebates related to products for which control has been transferred to customers.
Commercial Rebates: Commercial rebates are arrangements with third party payors where the Company will pay the
third-party payors rebates and other fees on eligible purchases of the Company’s product. In consideration for the rebates
and fees paid, the third-party payors will cover its’ patient purchases made of the Company’s products. The rebates and
fees paid will be treated as variable consideration and a reduction to the transaction price. We use the expected-value
method for estimating the ultimate rebate and fee paid, which are based on the volume of product sold. We apply the
applicable rebate rate against a payor mix factor for the relevant patient populations and to the vials sold in the effective
plan year of the rebate to derive a liability recorded. Estimates for these agreements are adjusted quarterly to reflect the
most recent information. We record an accrued liability for unpaid commercial rebates.
Chargebacks: Chargebacks are discounts that occur in multiple jurisdictions globally, whereby contracted parties
purchase directly from a specialty distributor. Contracted parties primarily consist of public health service institutions
and government entities. In the U.S., 340B and Veterans Affairs (VA) chargebacks are initiated through arrangements
between manufacturers and the government, for which the product is purchased at an agreed discounted price. The
reserves for chargeback are based on known sales to contracted parties. We establish the reserves for chargebacks in the
same period that the related revenue is recognized, resulting in an accrued liability and reduction of product gross sales.
Distributor fees: Specialty distributors provide distribution services to the Company for a fee, based on a contractually
determined fixed percentage of sales. As the services being provided by the specialty distributor are not distinct, the
recurring service fees paid to specialty distributors are treated as variable consideration and a reduction to the transaction
price. We estimate these distributor fees and record such estimates in the same period the related revenue is recognized,
resulting in a reduction of product gross sales. We record an accrued liability for unpaid distributor fees.
F-20 |
Other components of the variable considerations include co-pay assistance program, Medicare Part B discarded drug
refund program in the U.S., and product returns.
The estimated amounts described above are recognized in the consolidated statements of profit or loss and the
consolidated statements of other comprehensive income or loss within “Product net sales” as a reduction of gross sales,
and generally within “Trade and other payables” in the consolidated statements of financial position. They are subject to
regular review and adjustment as appropriate based on the most recent data available to management.
The Company has determined that sales rebates and reserves constitute a major source of estimation uncertainty as
disclosed in ‘‘ Note 3 — Critical accounting judgments and major sources of estimation uncertainty’’. The major source
of estimation uncertainty has been isolated to rebates and chargebacks as disclosed in ‘‘ Note 14 — Trade and Other
Payables’’. If management’s estimates differ from actual results, we will record adjustments that would affect product
sales in the period of adjustment.
Amongst the Company’s collaboration and license agreements in scope of IFRS 15, the following two have generated
revenue in the reporting periods:
Zai Lab
Under the collaboration agreement, the Company provides clinical and commercial supply to Zai Lab. The Company
concludes to recognize such sales as revenue given that the Company acts as principal in the transaction as the risk
related to inventory is borne by the Company until the inventory is transferred to Zai Lab. The revenue related to clinical
supply is recorded under line item “Other operating income”. The revenue related to commercial supply is recorded
under line item “Product net sales” in the Consolidated Statements of Profit or Loss. The income related to royalties or
sales-based milestones on sales made in China is recorded under line item “Other operating income”.
AbbVie
For the AbbVie Collaboration Agreement the Company has determined that the transfer of license combined with the
performance of research and development activities represent one single performance obligation. The Company
concluded that the license is not distinct in the context of the contract.
The transaction price is composed of a fixed part, being an upfront license fee, and a variable part, being milestone
payments and cost reimbursements for research and development activities delivered. Milestone payments are only
included in the transaction price to the extent it is highly probable that a significant reversal in the amount of cumulative
revenue recognition will not occur when the uncertainty associated with the variable consideration is subsequently
resolved. Management estimates the amount to be included in the transaction price upon achievement of the milestone
event. Sales-based milestones and sales-based royalties are a part of the Company’s arrangements but are not yet
included in its revenues.
The transaction price has been allocated to the single performance obligation and revenues have been recognized over
the estimated service period based on an input model, being the percentage of completion method. The upfront license
fee has been fully recognized since 2021 as the performance obligation has been fulfilled at that time. Milestone
payments that become highly probable after the performance obligation has been fulfilled are therefore recognized at that
point in time.
Cost of sales are recognized when the associated revenue from product net sales is recognized. Cost of sales include
material, manufacturing costs and other costs attributable to production, including shipping costs relevant amortizations,
as well as royalties payable on sold products.
In the application of the Company’s accounting policies, which are described above, the Company is required to make
judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent
from other sources. The estimates and associated assumptions are based on historical experience and other factors that
are considered to be relevant. Actual results may differ from these estimates.
F-21 |
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are
recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the
revision and future periods if the revision affects both current and future periods.
Product Sales are recognized when the Company has transferred control of the goods to the customer. Product Sales are
subject to various deductions, which are primarily composed of rebates to government agencies, distributors, health
insurance companies and managed healthcare organizations to arrive to ‘‘Product net sales’’. Certain deductions from
Product Sales are subject to payment based on claims after the initial recognition of the sale due to the time lag between
the point of sale and receipt of a claim.
Upon initial recognition of the Product Sales, the Company recognizes a liability for the variable consideration based on
the Company’s best estimate of expected claims. This estimate is a source of complexity and uncertainty as the Company
specifically estimates the payor mix. Additionally, the transaction price is based upon contracts with customers,
healthcare providers, payors and government agencies, regulated discounts applicable to government-funded programs,
historical experience of claims received and other relevant factors. These open claims are recorded as liabilities under
“Sales rebates and reserves’’ in the ‘‘Consolidated Statements of Financial Position’’.
The Company reviews these liabilities at each reporting period to take into account potential changes in the programs,
the volume of claims and/or the most probable final outcome associated to each sale. In line with IFRS 15, the Company
applies constraint in recognition of variable compensation on Product Net Sales. Due to the nature of these liabilities it is
not practicable to give meaningful sensitivity estimates due to the large volume of variables that contribute to Medicare
Part D, commercial rebates and chargebacks as outlined in “Note 2.17 — Product net sales”. Future events could cause
the assumptions within our valuation models to change and materially affect the future results of the Company.
Please refer to “Note 14 — Trade and Other Payables” for the movement over the period and the ending balance of the
sales rebates and reserves.
The Company has not exercised a critical accounting judgment in the current year ended December 31, 2025. As of the
year ended December 31, 2024, the Company had applied judgment related to the number of years of forecasted future
taxable profits to be considered as reliable as positive evidence towards its estimate on recognition of deferred tax assets.
The Company considers that as of December 31, 2025, the recognition of its deferred tax assets do not constitute a
critical accounting judgment based on the facts and circumstances; specifically, significant growth in the U.S. based
Product Net Sales, current and future taxable profit levels and the current external competitive landscape.
No other Critical accounting judgments and major sources of estimation uncertainty have been made in the current
period by the Company.
F-22 |
(in thousands of $) | IT, office and lab equipment | Right-of-use assets Buildings | Right-of-use assets Vehicles | Leasehold improvements | Leased equipment | Total | ||||||||||||
Cost | ||||||||||||||||||
On January 1, 2023 | $ | $ | $ | $ | $ | $ | ||||||||||||
Additions | ||||||||||||||||||
Disposals | ( | ( | ( | ( | ||||||||||||||
On December 31, 2023 | ||||||||||||||||||
Additions | ||||||||||||||||||
Disposals | ( | ( | ( | ( | ||||||||||||||
On December 31, 2024 | ||||||||||||||||||
Additions | ||||||||||||||||||
Disposals | ( | ( | ( | ( | ||||||||||||||
On December 31, 2025 | $ | $ | $ | $ | $ | $ | ||||||||||||
Depreciation and impairment | ||||||||||||||||||
On January 1, 2023 | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | ||||||
Depreciation | ( | ( | ( | ( | ( | ( | ||||||||||||
Disposals | ||||||||||||||||||
On December 31, 2023 | ( | ( | ( | ( | ( | ( | ||||||||||||
Depreciation | ( | ( | ( | ( | ( | ( | ||||||||||||
Disposals | ||||||||||||||||||
On December 31, 2024 | ( | ( | ( | ( | ( | ( | ||||||||||||
Depreciation | ( | ( | ( | ( | ( | ( | ||||||||||||
Disposals | ||||||||||||||||||
On December 31, 2025 | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | $ | ( | ||||||
Carrying Amount | ||||||||||||||||||
On December 31, 2023 | $ | $ | $ | $ | $ | $ | ||||||||||||
On December 31, 2024 | ||||||||||||||||||
On December 31, 2025 | $ | $ | $ | $ | $ | $ | ||||||||||||
Depreciation is recognized as from the moment when the asset is ready for its intended use to depreciate the cost of the
assets less their residual values over their useful lives, using the straight-line method. Unless revised due to specific
changes in the estimated useful life, annual depreciation rates are as follows:
•Office and lab equipment: three to five years
•IT equipment: three years
Depreciation of right-of-use assets is done over the expected duration of the lease including lease extensions where
applicable.
As of December 31, 2025, there are no material commitments to acquire property, plant and equipment. Furthermore, no
items of property, plant and equipment are pledged. See “Note 20 — Leases” for information for leases where the
Company is a lessee.
F-23 |
(in thousands of $) | Acquired R&D available for use | Acquired In- Process R&D | Other Intangibles1) | Total | ||||||||
Cost | ||||||||||||
On January 1, 2023 | $ | $ | $ | $ | ||||||||
Additions | ||||||||||||
Disposals | ( | ( | ||||||||||
Reclassification | ( | |||||||||||
On December 31, 2023 | $ | $ | $ | |||||||||
Additions | ||||||||||||
On December 31, 2024 | $ | $ | $ | |||||||||
Additions | ||||||||||||
Reclassification | ( | |||||||||||
On December 31, 2025 | $ | $ | $ | $ | ||||||||
Amortization and impairment | ||||||||||||
On January 1, 2023 | $ | $ | $ | ( | $ | ( | ||||||
Amortization | ( | ( | ( | |||||||||
Disposals | ||||||||||||
On December 31, 2023 | ( | $ | $ | ( | $ | ( | ||||||
Amortization | ( | ( | ( | |||||||||
On December 31, 2024 | ( | $ | $ | ( | $ | ( | ||||||
Amortization | ( | ( | ( | |||||||||
Reclassification | ( | |||||||||||
On December 31, 2025 | $ | ( | $ | $ | ( | $ | ( | |||||
Carrying Amount | ||||||||||||
On December 31, 2023 | $ | $ | $ | $ | ||||||||
On December 31, 2024 | ||||||||||||
On December 31, 2025 | $ | $ | $ | $ | ||||||||
1)Comparative figures have been aligned to the presentation adopted in the current year.
“Acquired R&D available for use” and “Acquired In-Process R&D” is mainly related to the in-licensing of the
ENHANZE® drug delivery technology from Halozyme. In line with its accounting policies, the Company has capitalized
the upfront payment upon commencement of the in-license agreement. In June 2023, the Company obtained the FDA
approval for VYVGART HYTRULO. During the year ended December 31, 2023, upon obtaining regulatory approval,
$53
In 2024, the Company extended its collaboration with Halozyme and nominated four new targets to be in-licensed to the
ENHANZE® drug delivery technology. The cost of the license was capitalized as
“Acquired In-Process R&D”.
Further, the additions in 2025 to “Acquired R&D available for use” are mainly related to sales-based milestones in the
context of the Halozyme agreement. The “Acquired R&D available for use” are amortized under “Cost of sales” on a
straight-line basis over their useful life. The Company performs an annual impairment review on the intangible assets.
This review did not result in the recognition of an impairment charge for the years ended December 31, 2025, 2024 and
2023.
F-24 |
In the fourth quarter of 2023, the Company utilized the PRV submitted with the sBLA filing for VYVGART HYTRULO
for the treatment of CIDP, which resulted in the amortization of $102 million of intangible assets which is recognized
under “Research and development expenses” within the consolidated statements of profit or loss and the consolidated
statements of other comprehensive income or loss and subsequent derecognition of $102 million of intangibles included
under “Other intangibles” on the consolidated statements of financial position.
The Company continually assesses the useful life of intangible assets based on the shorter of its expected useful life and
legal life. Currently, intangible assets are amortized over a range of three to more than fifteen years .
As of December 31, 2025, there are no material commitments to acquire intangible assets, except as set forth in
“Note 27 — Commitments”. No intangible assets are pledged as security for liabilities nor are there any intangible assets
whose title is restricted.
Other non-current assets consisted of non-current restricted cash and financial assets held at fair value through profit or
loss or through OCI.
As of December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Non-current restricted assets | $ | $ | $ | ||||||
Non-current financial assets held at fair value through profit or loss | |||||||||
Non-current financial assets held at fair value through OCI | |||||||||
Total other non-current assets | $ | $ | $ | ||||||
Non-current restricted assets on December 31, 2025 was mainly composed of deposit guarantees paid under the lease
agreements for the laboratory and offices of the Company.
Non-current financial assets held at fair value through profit or loss is comprised of the profit share in AgomAb
Therapeutics NV. In March 2019, the Company entered into a license agreement with AgomAb Therapeutics NV for the
use of HGF-mimetic SIMPLE Antibodies™, developed under the Company’s Immunology Innovative Program. In
exchange for granting this license, the Company received a profit share in AgomAb Therapeutics NV. Since AgomAb
Therapeutics NV is a private company, the valuation of the profit share is based on the post-money valuation coming
from its most recent financing round.
In October 2023, AgomAb Therapeutics NV secured €100 million as a result of a Series C financing round. The
Company’s profit share was diluted, but resulting in no change of the fair value. In October 2024, AgomAb Therapeutics
NV secured $89 million as a result of a Series D financing round.
The Company reassessed the fair value of the asset as of December 31, 2025 based on publicly available clinical
announcements as of the reporting date.
Fair value changes on non-current financial assets with fair value through profit or loss are recognized in the
consolidated statements of profit or loss and the consolidated statements of other comprehensive income or loss under
“Other operating income”.
As part of the license agreement for the development and commercialization for efgartigimod in Greater China, in 2021
the Company obtained, amongst others, 568,182 newly issued Zai Lab shares calculated at a price of €132 per share. The
fair value of the equity instrument at reporting date is determined by reference to the closing price of such securities at
each reporting date (classified as level 1 in the fair value hierarchy). The Company made the irrevocable election to
recognize subsequent changes in fair value through OCI under “Fair value gain/(loss) on investments in equity
instruments designated as at FVTOCI”.
F-25 |
As of December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Cost on January 1 | $ | $ | $ | ||||||
Additions of the year | |||||||||
Cost on December 31 | $ | $ | $ | ||||||
Fair value adjustments on January 1 | $ | ( | $ | ( | $ | ( | |||
Fair value adjustment of the year through profit or loss | |||||||||
Fair value adjustment of the year through OCI | ( | ( | ( | ||||||
Fair value adjustment on December 31 | $ | ( | $ | ( | $ | ( | |||
Net book value on December 31 | $ | $ | $ | ||||||
As of December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Raw materials and consumables | $ | $ | $ | ||||||
Inventories in process | |||||||||
Finished goods | |||||||||
Total inventories | $ | $ | $ | ||||||
The cost of inventories, which is recognized under “Cost of sales” in the consolidated statements of profit or loss and the
consolidated statements of other comprehensive income or loss, amounted to $243 million for the year ended
December 31, 2025 (compared to $168 million for the year ended December 31, 2024 and $101 million for the year
ended December 31, 2023).
The Company has pre-launch inventory awaiting regulatory approval amounting to $37 million as of the year ended
December 31, 2025 compared to $5 million as of December 31, 2024 and $101 million as of December 31, 2023.
As of December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Prepaid research and development expenses | $ | $ | $ | ||||||
Prepaid software | |||||||||
Prepaid inventory | |||||||||
Prepaid advertising expenses | |||||||||
Other prepaid expenses | |||||||||
Total prepaid expenses | $ | $ | $ | ||||||
F-26 |
As of December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Trade receivables | $ | $ | $ | ||||||
Tax receivables | |||||||||
Interest receivables | |||||||||
Other receivables | |||||||||
Total trade and other receivables | $ | $ | $ | ||||||
The carrying amounts of trade and other receivables approximate their respective fair values. On December 31, 2025,
2024 and 2023, we did not have a material provision for expected credit losses.
Please also refer to “Note 24 — Financial Risk Management” for more information on the financial risk management.
These current financial assets relate to term accounts with an initial maturity longer than three months and less than 12
months and money market funds that do not qualify as cash equivalents as they are not expected to be used to meet
short-term commitments.
As of December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Term accounts | |||||||||
Total current financial assets | $ | $ | $ | ||||||
On December 31, 2025, the current financial assets included $59 million (€50 million) held in EUR (compared to
$104 million (€100 million) for the year ended December 31, 2024 and $221 million (€200 million) for the year ended
December 31, 2023) which could generate a foreign currency exchange gain or loss in the financial results in accordance
with the fluctuations of the USD/EUR exchange rate as the Company’s functional currency is USD.
Please also refer to “Note 24 — Financial Risk Management” for more information on the financial risk management.
As of December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Money market funds | $ | $ | $ | ||||||
Term accounts | |||||||||
Cash and bank balances | |||||||||
Total cash and cash equivalents | $ | $ | $ | ||||||
Cash and cash equivalents comprise of cash and bank balances, term accounts with an original maturity not exceeding
three months and money market funds that are readily convertible to cash and are subject to an insignificant risk of
changes in value.
Cash positions are invested with preferred financial partners, which are considered to be high quality financial
institutions with sound credit ratings to reduce credit risk.
On December 31, 2025, the cash and cash equivalents included $97 million (€83 million) held in EUR (compared to
$653 million (€628 million) for the year ended December 31, 2024 and $703 million (€636 million) for the year ended
F-27 |
December 31, 2023) which could generate a foreign currency exchange gain or loss in the financial results in accordance
with the fluctuation of the USD/EUR exchange rate as the Company’s functional currency is USD.
Please also refer to “Note 24 — Financial Risk Management” for more information on the financial risk management.
As of December 31, 2025, the Company’s share capital was represented by 61,883,306 shares. All shares were issued,
fully paid up and of the same class. The table below summarizes the share issuances as a result of offerings, exercise of
stock options and the vesting of restricted stock units under the Company’s Employee Stock Option Plan.
Number of shares outstanding on January 1, 2023 | ||
Exercise of stock options | ||
Vesting of RSUs | ||
Global public offering on Nasdaq on July 18, 2023 | ||
Over-allotment option exercised by underwriters on July 19, 2023 | ||
Number of shares outstanding on December 31, 2023 | ||
Exercise of stock options | ||
Vesting of RSUs | ||
Number of shares outstanding on December 31, 2024 | ||
Exercise of stock options | ||
Vesting of RSUs | ||
Number of shares outstanding on December 31, 2025 |
On July 18, 2023, argenx SE offered 2,244,899 of its ordinary shares through a global offering which consisted of
expenses; and 663,918 ordinary shares in the European Economic Area at a price of €436.37 per share, before
underwriting discounts and commissions and offering expenses. On July 19, 2023, the underwriters of the offering
exercised their overallotment option to purchase 336,734 additional ADSs in full. As a result, argenx SE received $1.3
billion in gross proceeds from this offering, decreased by $66 million of underwriter discounts and commissions, and
offering expenses, of which $1 million has been deducted from equity. The total net cash proceeds from the offering
amounted to $1.2 billion.
On May 27, 2025, at the annual general meeting, the shareholders of the Company approved the authorization to the
Board to issue up to a maximum of 10 % of the then-outstanding share capital, for a period of 18 months.
On December 31, 2025, an amount of €532,863 , represented by 5,328,634 shares, still remained available under the
The Company has an equity incentive plan for the employees, key consultants, board members, senior management and
key outside advisors (‘’key persons”) of the Company and its subsidiaries. In accordance with the terms of the plan, as
approved by shareholders, employees may be granted stock options and/or restricted stock units and/or performance
stock units.
The stock options are granted to key persons of the Company and its subsidiaries. The stock options may be granted to
purchase ordinary shares at an exercise price. The stock options have been granted free of charge. Each employee’s stock
option converts into one ordinary share of the Company upon exercise. The stock options carry neither rights to
dividends nor voting rights. Stock options may be exercised at any time from the date of vesting to the date of their
expiry.
The stock options granted vest, in principle, as follows:
F-28 |
•1/3rd of the total stock options granted will vest on the first anniversary of the granting of the stock options, and
•1/36th of the total stock options granted will vest on the first day of each month following the first anniversary of the
granting of the stock options.
Stock options granted to non-executive directors vest on the third anniversary of the date of grant.
Upon leave of the key persons stock options must be exercised before the later of (i) 90 days after the last working day at
argenx, or (ii) March 31 of the fourth year following the date of grant of those stock options, and in any case no later
than the expiration date of the option.
In order to pre-finance the taxes that are paid upon the grant of stock options, Belgian employees have the ability, in
exchange for the taxes due upon the grant of the stock options, to transfer the economic benefits related to part of those
stock options to a third party. In the year ending December 31, 2025, the economic benefits of 12,951 stock options, for
which accelerated vesting applies, were transferred to a third party.
No other conditions are attached to stock options.
at the end of each period presented:
Outstanding stock options on December 31, | |||||||||
Expiry date | Exercise price per stock options (in $)¹⁾ | 2025 | 2024 | 2023 | |||||
2024 | $ | ||||||||
2024 | |||||||||
2024 | |||||||||
2025 | |||||||||
2025 | |||||||||
2026 | |||||||||
2026 | |||||||||
2026 | |||||||||
2027 | |||||||||
2027 | |||||||||
2028 | |||||||||
2028 | |||||||||
2024 | |||||||||
2029 | |||||||||
2024 | |||||||||
2029 | |||||||||
2025 | |||||||||
2030 | |||||||||
2025 | |||||||||
2030 | |||||||||
2025 | |||||||||
2030 | |||||||||
2025 | |||||||||
2030 | |||||||||
2026 | |||||||||
2031 | |||||||||
2026 | |||||||||
2031 | |||||||||
2026 | |||||||||
2031 | |||||||||
2025 | |||||||||
F-29 |
Outstanding stock options on December 31, | |||||||||
Expiry date | Exercise price per stock options (in $)¹⁾ | 2025 | 2024 | 2023 | |||||
2026 | |||||||||
2031 | |||||||||
2027 | |||||||||
2032 | |||||||||
2027 | |||||||||
2032 | |||||||||
2027 | |||||||||
2032 | |||||||||
2027 | |||||||||
2032 | |||||||||
2028 | |||||||||
2033 | |||||||||
2028 | |||||||||
2033 | |||||||||
2028 | |||||||||
2033 | |||||||||
2028 | |||||||||
2033 | |||||||||
2029 | |||||||||
2034 | |||||||||
2029 | |||||||||
2034 | |||||||||
2029 | |||||||||
2034 | |||||||||
2029 | |||||||||
2034 | |||||||||
2030 | |||||||||
2035 | |||||||||
2030 | |||||||||
2035 | |||||||||
2030 | |||||||||
2035 | |||||||||
2030–2035²⁾ | $ | ||||||||
1)Amounts have been converted to USD at the closing rate as of December 31, 2025.
2)In December 2025, the Company granted stock options for which the Belgian taxed beneficiaries had a 60-day period to choose between a
contractual term of five or ten years .
F-30 |
2025 | 2024 | 2023 | |||||||||||||
Number of stock options | Weighted average exercise price¹⁾ | Number of stock options | Weighted average exercise price¹⁾ | Number of stock options | Weighted average exercise price¹⁾ | ||||||||||
Outstanding as of January 1 | $ | $ | $ | ||||||||||||
Granted | |||||||||||||||
Exercised | ( | ( | ( | ||||||||||||
Forfeited | ( | ( | ( | ||||||||||||
Outstanding as of December 31 | |||||||||||||||
Exercisable as of December 31 | $ | $ | $ | ||||||||||||
1) Amounts have been converted to USD at the closing rate of the respective period.
The weighted average share price at the date of exercise of options exercised during the year ended December 31, 2025
was $754.00 , compared to $498.58 during the year ended December 31, 2024 and $456.80 during the year ended
December 31, 2023. The weighted average remaining contractual life of the stock options outstanding amounted to 5.68
years on December 31, 2025 compared to 5.89 years on December 31, 2024 and 5.90 years on December 31, 2023. The
table below shows the weighted average remaining contractual life for each range of exercise price:
Exercise price (in $) | Outstanding on December 31, 2025 | Weighted average remaining contractual life (in years) | ||
The fair market value of the stock options has been determined based on the Black-Scholes model using the following
unobservable assumptions:
•The expected volatility, determined on the basis of the implied volatility of the share price over the expected life of
the option.
•The expected option life, calculated as the estimated duration until exercise, taking into account the specific features
of the plans.
F-31 |
Stock options granted in | March 2025 | June 2025 | September 2025 | December 2025¹⁾ | |||||||||
Number of options granted | |||||||||||||
Average Fair value of options (in $)²⁾ | $ | $ | $ | $ | |||||||||
Share price (in $)²⁾ | $ | $ | $ | $ | |||||||||
Exercise price (in $)²⁾ | $ | $ | $ | $ | |||||||||
Expected volatility | % | % | % | % | |||||||||
Average Expected option life (in years) | |||||||||||||
Risk‑free interest rate | % | % | % | % | |||||||||
Expected dividends | % | % | % | % | |||||||||
1)In December 2025, the Company granted a total of 17,595 stock options of which 1,833 stock options to Belgian taxed beneficiaries. Belgian
taxed beneficiaries can choose between a contractual term of five or ten years . The expected option life ranges between 3.88 and 6.07 years. This
estimate will be reassessed once the acceptance period of 60 days has passed and the beneficiaries will have made a choice between a contractual
term of five or ten years . The total difference in fair value of the grant to Belgian taxed beneficiaries would not be material irrespective of 100 %
of the stock options of Belgian taxed beneficiaries with a contractual term of five years or ten years .
2)Amounts have been converted to USD at the applicable rate prevailing at the grant date.
Below is an overview of the parameters used in relation to the determination of the fair value of grants during 2024:
Stock options granted in | April 2024 | June 2024 | September 2024 | December 2024¹⁾ | |||||||||
Number of options granted | |||||||||||||
Average Fair value of options (in $)²⁾ | $ | $ | $ | $ | |||||||||
Share price (in $)²⁾ | $ | $ | $ | $ | |||||||||
Exercise price (in $)²⁾ | $ | $ | $ | $ | |||||||||
Expected volatility | % | % | % | % | |||||||||
Average Expected option life (in years) | |||||||||||||
Risk‑free interest rate | % | % | % | % | |||||||||
Expected dividends | % | % | % | % | |||||||||
1)In December 2024, the Company granted a total of 20,296 stock options. Belgian beneficiaries could choose between a contractual term of five or
which the beneficiaries made a choice between a contractual term of five or ten years years, the parameters and fair value used in the financial
year ending December 31, 2024 were reassessed.
2)Amounts have been converted to USD at the applicable rate prevailing at the grant date.
Below is an overview of the parameter used in relation to the determination of the fair value of grants during 2023:
F-32 |
Stock options granted in | April 2023 | July 2023 | October 2023 | December 2023 | |||||||||
Number of options granted | |||||||||||||
Average Fair value of options (in $)¹⁾ | $ | $ | $ | $ | |||||||||
Share price (in $)¹⁾ | $ | $ | $ | $ | |||||||||
Exercise price (in $)¹⁾ | $ | $ | $ | $ | |||||||||
Expected volatility | % | % | % | % | |||||||||
Average Expected option life (in years) | |||||||||||||
Risk‑free interest rate | % | % | % | % | |||||||||
Expected dividends | % | % | % | % | |||||||||
1)Amounts have been converted to USD at the applicable rate prevailing at the grant date.
The total share-based payment expense related to stock options recognized in the consolidated statements of profit or
loss totaled $128 million for the year ended December 31, 2025, compared to $147 million for the year ended
December 31, 2024 and $164 million for the year ended December 31, 2023.
The RSUs are granted to key persons of the Company and its subsidiaries. The RSUs have been granted free of charge.
Each employee’s RSUs converts into one ordinary share of the Company upon vesting. The RSUs carry neither rights to
dividends nor voting rights. RSUs once converted into ordinary shares, may be sold at any time from the date of vesting,
have no expiry date and may be held by the participant without limitation. The fair value of RSUs is based on the closing
sale price of the Company’s common stock on the day prior to the date of issuance. RSUs vest over a period of four
RSUs granted to non-executive directors prior to the year ended December 31, 2024 vest over a period of four years with
1/4th of the total grant vesting at each anniversary of the date of grant. RSUs granted to non-executive directors as from
the year ended December 31, 2024 vest at the one year anniversary of the grant and are subject to a holding period of
period.
2025 | 2024 | 2023 | |||||||||||||
Number of RSUs | Weighted average Grant Date Fair Value1) | Number of RSUs | Weighted average Grant Date Fair Value1) | Number of RSUs | Weighted average Grant Date Fair Value1) | ||||||||||
Non-vested units on January 1 | $ | $ | $ | ||||||||||||
Granted | |||||||||||||||
Vested | ( | ( | ( | ||||||||||||
Forfeited | ( | ( | ( | ||||||||||||
Non-vested units on December 31 | $ | $ | $ | ||||||||||||
1)Amounts have been converted to USD at the closing rate of the respective period.
The total share-based payment expense related to RSUs recognized in the consolidated statements of profit or loss
totaled $115 million for the year ended December 31, 2025 compared to $88 million for the year ended December 31,
2024 and $69 million for the year ended December 31, 2023.
F-33 |
The PSUs are granted to key persons of the Company and its subsidiaries. The PSUs have been granted free of charge.
Each employee’s PSUs converts into one ordinary share of the Company upon vesting. The PSUs carry neither rights to
dividends nor voting rights. PSUs once converted into ordinary shares, may be sold at any time from the date of vesting,
have no expiry date and may be held by the participant without limitation. The fair value of PSUs is based on the closing
sale price of our Company’s common stock on the day prior to the date of issuance. PSUs vest at the end of their three
target and maximum levels as determined by the Board. PSUs have a maximum upside payout opportunity of 150 % of
target.
The Company granted 30,360 units of PSUs on June 30, 2025.
2025 | |||||
Number of PSUs | Weighted average Grant Date Fair Value1) | ||||
Non-vested units on January 1 | $ | ||||
Granted | |||||
Vested | |||||
Forfeited | |||||
Non-vested units on December 31 | $ | ||||
1)Amounts have been converted to USD at the closing rate of the respective period.
This was the first grant of PSUs by the Company, there are therefore no comparable periods.
The total share-based payment expense related to PSUs recognized in the consolidated statements of profit or loss totaled
As of December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Trade payables | $ | $ | $ | ||||||
Sales rebates and reserves | |||||||||
Short‑term employee benefits | |||||||||
Other | |||||||||
Total trade and other payables | $ | $ | $ | ||||||
The carrying amounts of trade and other payables approximate their respective fair values. Trade payables correspond
primarily to R&D, commercial and manufacturing activities and include accrued expenses related to these activities.
Short-term employee benefits include payables and accruals for salaries and bonuses to be paid to the employees of the
Company.
2024 and 2023:
F-34 |
(in thousands of $) | Rebates and chargebacks | Distribution fees, product returns | Total sales rebates and reserves | ||||||
Balance on January 1, 2023 | $ | $ | $ | ||||||
Current estimate related to the sales made in the current year | |||||||||
Adjustment for prior periods | ( | ( | ( | ||||||
Credits or payments1) | ( | ( | ( | ||||||
Balance on December 31, 2023 | $ | $ | $ | ||||||
Current estimate related to the sales made in the current year | |||||||||
Adjustment for prior periods | ( | ( | ( | ||||||
Credits or payments1) | ( | ( | ( | ||||||
Balance on December 31, 2024 | $ | $ | $ | ||||||
Current estimate related to the sales made in the current period | |||||||||
Adjustment for prior periods | ( | ( | |||||||
Credits or payments | ( | ( | ( | ||||||
Foreign currency translation differences | ( | ||||||||
Balance on December 31, 2025 | $ | $ | $ |
1)Comparative figures have been aligned to the presentation adopted in the current year.
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 20241) | 20231) | ||||||
Research and development incentives | $ | $ | $ | ||||||
Payroll tax rebates | |||||||||
Collaboration revenue | |||||||||
Change in fair value on non-current financial assets | |||||||||
Other operating income | |||||||||
Total other operating income | $ | $ | $ | ||||||
1)Comparative figures have been aligned with the presentation adopted in the current year.
For the year ended December 31, 2025, the collaboration revenue was generated under the agreement with Zai Lab. This
note should be read alongside ‘‘Note 2.18 — Other operating income - Collaboration and license agreements’’.
The Company has accounted for tax incentives following a research and development tax incentive scheme in Belgium
according to which the incentive will be refunded after a 5 years period, if not offset against the current tax payable over
the period.
The Company accounted for payroll tax rebates as a reduction in withholding income taxes for its highly qualified
personnel employed in its research and development department.
F-35 |
In April 2016, the Company entered into the AbbVie Collaboration Agreement to develop and commercialize
ARGX-115 (ABBV-151). In October 2023, the Company achieved the second development milestone upon initiation of
a non-pivotal clinical trial, triggering a $30 million payment.
Subject to the continuing progress of ARGX-115 (ABBV-151) by AbbVie, the Company is eligible to receive future
development, regulatory and commercial milestone payments in aggregate amounts of up to $50 million, $190 million
and $325 million, respectively, as well as tiered royalties on sales at percentages ranging from the mid-single digits to
the lower teens, subject to customary reductions.
The Company manages its activities and operates as one business unit which is reflected in its organizational structure
and internal reporting. The Company does not distinguish in its internal reporting different segments, neither business
nor geographical segments. The chief operating decision-maker is the Board of Directors.
product net sales:
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 20241) | 2023 | ||||||
United States | $ | $ | $ | ||||||
Japan | |||||||||
China | |||||||||
Rest of the World | |||||||||
Total product net sales | $ | $ | $ | ||||||
1)Comparative figures have been presented to be consistent with the presentation adopted in the current year.
Four U.S. customers represent approximately 78 % of the product net sales during the twelve months ended
December 31, 2025 (compared to five U.S. customers which represented 87 % in 2024 and four customers which
represented 86 % for the same period in 2023).
shown in the table below:
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Belgium | |||||||||
United States | |||||||||
Japan | |||||||||
Rest of the World | |||||||||
Total non-current assets | $ | $ | $ | ||||||
Product net sales and non-current assets in the Netherlands, the Company’s country of domicile, are not material.
F-36 |
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
External research and development expenses | $ | $ | $ | ||||||
Personnel expenses | |||||||||
Digital technology expenses | |||||||||
Materials and consumables | |||||||||
Depreciation and amortization | |||||||||
Other expenses | |||||||||
Total Research and development expenses | $ | $ | $ | ||||||
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 20241) | 20231) | ||||||
Personnel expenses | $ | $ | $ | ||||||
Marketing services | |||||||||
Professional fees | |||||||||
Digital technology expenses | |||||||||
Distribution and commercial support expenses | |||||||||
Facilities and occupancy expenses | |||||||||
Supervisory board | |||||||||
Depreciation and amortization | |||||||||
Other expenses | |||||||||
Total Selling, general and administrative expenses | $ | $ | $ | ||||||
1)Comparative figures have been aligned with the presentation adopted in the current year.
General and Administrative Expenses’’ above are as follows:
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Short‑term employee benefits - Salaries | $ | $ | $ | ||||||
Short‑term employee benefits - Social Security | |||||||||
Post‑employment benefits | |||||||||
Termination benefits | |||||||||
Share‑based payment | |||||||||
Employer social security contributions share-based payments | |||||||||
Total personnel expenses | $ | $ | $ | ||||||
The post-employment benefits relate to the pension plans the Company has in place for its employees.
F-37 |
Year Ended December 31, | |||||||||
Average Number of FTEs | 2025 | 2024 | 2023 | ||||||
Research and development | |||||||||
Selling, general and administrative | |||||||||
Total number of FTEs | |||||||||
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Right-of-use assets | |||||||||
Buildings | $ | $ | $ | ||||||
Vehicles | |||||||||
Equipment | |||||||||
$ | $ | $ | |||||||
Lease liabilities | |||||||||
Current | $ | $ | $ | ||||||
Non-current | |||||||||
$ | $ | $ | |||||||
Additions to the right-of-use assets amounted to $20 million for the year ended December 31, 2025, compared to $26
million and $11 million for the years ended December 31, 2024 and 2023 respectively.
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Lease liabilities | |||||||||
Less than 1 year | $ | $ | $ | ||||||
Years 1 through 5 | |||||||||
Greater than 5 years | |||||||||
Total contractual cash flows | $ | $ | $ | ||||||
Total carrying amount | $ | $ | $ | ||||||
1)Comparative figures have been aligned with the presentation adopted in the current year.
shows the following amounts relating to leases:
F-38 |
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Depreciation charges | |||||||||
Buildings | $ | $ | $ | ||||||
Vehicles | |||||||||
Equipment | |||||||||
$ | $ | $ | |||||||
Interest expense (included in finance cost) | $ | $ | $ | ||||||
The total cash outflows for leases in 2025, 2024 and 2023 were $4 million, $8 million and $4 million respectively.
The Company applies the short-term lease recognition exemption (i.e., those leases that have a lease term of 12 months
or less from the commencement date and do not contain a purchase option) and the lease of low-value assets recognition
exemption. Lease payments on short-term leases and leases of low-value assets are immaterial and are recognized as an
expense within the operating category in the statement of profit on a straight-line basis over the lease term.
The Company does not have any lease agreement with variable lease payments or residual value guarantees. The
Company has several leases that include extension and termination options. These options provide flexibility in
managing the leased-asset portfolio and align with the Company’s business needs. The Company exercises judgment in
determining whether these extension and termination options are reasonably certain to be exercised. The undiscounted
potential future rental payments relating to periods following the exercise date of extension and termination options that
are not included in the lease term are not material.
The exchange gains/losses for the year ended December 31, 2025 and prior periods were primarily attributable to
unrealized exchange rate gains on the cash and cash equivalents and current financial assets position in EUR due to the
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
Current year | $ | ( | $ | ( | $ | ( | |||
Income tax prior years | ( | ( | |||||||
Current tax expense | ( | ( | ( | ||||||
Recognition of deferred tax assets | |||||||||
Originating and reversal of temporary differences | |||||||||
Deferred tax benefit | |||||||||
Total income tax benefit | $ | $ | $ | ||||||
statutory tax rate to income before provision for income taxes is as follows:
F-39 |
Year Ended December 31, | |||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||
(Profit)/Loss before taxes | $ | ( | $ | ( | $ | ||||
Income tax (expense)/benefit calculated at the Dutch statutory federal income tax rates | ( | ( | |||||||
Effect of intercompany asset deal/transaction | |||||||||
Effect of expenses not deductible in determining taxable | ( | ( | ( | ||||||
Effect of share-based payment expenses that are not deductible in determining taxable results | ( | ( | ( | ||||||
Effect of stock issue expenses that are not taxable in determining taxable results | |||||||||
Effect of tax credits and incentives1) | |||||||||
Effect of change of (de)recognition of deferred tax assets on tax losses | ( | ( | |||||||
Effect of different tax rates in jurisdictions in which the company operates | ( | ||||||||
Effect of change of (de)recognition of deferred tax assets | ( | ||||||||
Effect of foreign exchange translation | ( | ||||||||
Other | ( | ( | |||||||
Income tax (expense)/benefit recognized in the consolidated statements of profit or loss | $ | $ | $ | ||||||
1)This item was renamed from ‘Effect of concessions’ to enhance clarity for financial statement presentation.
Deferred tax assets are recognized to the extent that it is probable that sufficient taxable profits will be available in the
look-forward period. In the fourth quarter of 2024, the Company recognized a consolidated tax benefit for previously
unrecognized net deferred tax assets amounting to $725 million, based on the weight of available evidence.
As of December 31, 2025 | |||||||||
(in thousands of $) | Assets | Liabilities | Net | ||||||
Deferred tax assets/(liabilities) | |||||||||
Innovation income deduction credit | $ | $ | — | $ | |||||
Net operating loss carryforwards | — | ||||||||
Capitalized R&D expenses | — | ||||||||
Intangible assets | — | ||||||||
Accruals and allowances | — | ||||||||
Share-based payments | — | ||||||||
Profit in inventory | — | ||||||||
Other tax carryforwards | — | ||||||||
Property, plant and equipment | ( | ||||||||
Non-current fixed assets | — | ( | ( | ||||||
Other | ( | ||||||||
Netting by taxable entity | ( | ||||||||
Net deferred tax assets | $ | $ | $ | ||||||
F-40 |
As of December 31, 2024 | |||||||||
(in thousands of $) | Assets | Liabilities | Net | ||||||
Deferred tax assets/(liabilities) | |||||||||
Innovation Income deduction | $ | $ | — | $ | |||||
Net operating loss carryforwards | — | ||||||||
Capitalized R&D expenses | — | ||||||||
Intangible assets | — | ||||||||
Accruals and allowances | — | ||||||||
Share-based payments | — | ||||||||
Profit in inventory | — | ||||||||
Other tax carryforwards | — | ||||||||
Property, plant and equipment | ( | ||||||||
Non-current fixed assets | — | ( | ( | ||||||
Other | ( | ||||||||
Netting by taxable entity | ( | ||||||||
Net deferred tax assets/(liabilities) | $ | $ | $ | ||||||
As of December 31, 2023 | |||||||||
(in thousands of $) | Assets | Liabilities | Net | ||||||
Deferred tax assets/(liabilities) | |||||||||
Accruals and allowances | $ | $ | — | $ | |||||
Share-based payments | — | ||||||||
Profit in inventory | — | ||||||||
Other tax carryforwards | — | ||||||||
Property, plant and equipment | ( | ||||||||
Non-current fixed assets | — | ( | ( | ||||||
Other | — | ||||||||
Netting by taxable entity | ( | ||||||||
Net deferred tax assets/(liabilities) | $ | $ | ( | $ | |||||
(in thousands of $) | Deferred tax assets | Deferred tax liabilities | ||||
Balance on January 1, 2025 | $ | $ | ||||
Recognized in profit or loss | ||||||
Recognized in equity | ||||||
Effects of change in foreign exchange rate | ||||||
Balance on December 31, 2025 | $ | $ | ||||
F-41 |
(in thousands of $) | Deferred tax assets | Deferred tax liabilities | ||||
Balance on January 1, 2024 | $ | $ | ( | |||
Recognized in profit or loss | ||||||
Recognized in equity | ||||||
Effects of change in foreign exchange rate | ||||||
Balance on December 31, 2024 | $ | $ | ||||
(in thousands of $) | Deferred tax assets | Deferred tax liabilities | ||||
Balance on January 1, 2023 | $ | $ | ( | |||
Recognized in profit or loss | ||||||
Recognized in equity | ||||||
Effects of change in foreign exchange rate | ( | ( | ||||
Balance on December 31, 2023 | $ | $ | ( | |||
The Company also has unrecognized tax losses carried forward in the Netherlands in the amount of $56 million as of
December 31, 2025, compared to $46 million on December 31, 2024 and $33 million on December 31, 2023. These
losses carried forward do not have an expiration date based upon the applicable enacted tax legislation in the
Netherlands.
As of December 31, 2025, the Company has $209 million of undistributed earnings attributable to foreign subsidiaries
(compared to $125 million on December 31, 2024 and $128 million on December 31, 2023) for which no provision for
deferred tax liabilities have been recognized because the Company has control over the timing of the reversal of the
temporary differences and there are no plans of distributions in the foreseeable future.
The Company is subject to the OECD Pillar Two Directive and implementing domestic laws in 2025. The Pillar Two
Rules does not have a material impact on our effective tax rate or the recognition of our deferred tax assets.
The Company continues to apply the exception relating to recognizing and disclosing information about deferred tax
assets and liabilities related to legislation that is enacted to implement the OECD Pillar Two model rules.
Year Ended December 31 | |||||||||
(in thousands of $ except for shares and EPS) | 2025 | 2024 | 2023 | ||||||
Profit/(Loss) for the period | $ | $ | $ | ( | |||||
Weighted average number of shares used for basic profit/ (loss) per share | |||||||||
Basic profit/(loss) per share (in $) | $ | $ | $ | ( | |||||
Weighted average number of shares used for diluted profit/ (loss) per share | |||||||||
Diluted profit/(loss) per share (in $) | $ | $ | $ | ( | |||||
Profit/(loss) per ordinary share is calculated by dividing the profit/(loss) for the period by the weighted average number
of ordinary shares during the year. Diluted profit/(loss) per share is calculated by adjusting the weighted average number
of shares by in the money outstanding dilutive stock options, RSUs and PSUs.
As the Company reported a net loss in 2023, stock options and RSUs had an anti-dilutive effect rather than a dilutive
effect. As such, there is no difference between basic and diluted loss per ordinary share for this period.
F-42 |
The financial risks are managed centrally. The Company coordinates the access to national and international financial
markets and considers and manages continuously the financial risks concerning the Company’s activities. These relate to
credit risk, liquidity risk, interest rate risk and currency risk. The Company does not buy or trade financial instruments
for speculative purposes.
Measurement category | Carrying amount on December 31 | ||||||||||
(in thousands of $) | 2025 | 2024 | 2023 | ||||||||
Financial assets - non-current | FVTPL | $ | $ | $ | |||||||
Financial assets - non-current | FVTOCI | ||||||||||
Research and development incentive receivables - non-current | Amortized cost | ||||||||||
Restricted assets - non-current | Amortized cost | ||||||||||
Trade and other receivables | Amortized cost | ||||||||||
Financial assets - current | Amortized cost | ||||||||||
Research and development incentive receivables - current | Amortized cost | ||||||||||
Cash and bank balances | Amortized cost | ||||||||||
Cash equivalents | FVTPL | ||||||||||
Cash equivalents | Amortized cost | ||||||||||
Trade and other payables | Amortized cost | ||||||||||
The carrying amounts of research and development incentive receivables, financial assets, trade and other receivables,
and trade and other payables are considered to be the same as their fair values, due to their short-term nature.
Financial assets held at fair value through profit or loss or OCI consisted of equity instruments of listed and non-listed
companies and money market funds.
The Company has no restrictions on the sale of these equity instruments and the assets are not pledged under any of its
liabilities. These instruments are classified as financial assets held at fair value through profit or loss or OCI which
qualify for:
•Level 1 fair value measurement with respect to current financial assets and cash equivalents based upon the closing
price (net asset value) of such securities at each reporting date.
•Level 3 fair value measurement with respect to non-current financial assets.
The market price of these financial instruments might face fluctuations and might be affected by a variety of factors,
such as the global economic situation. Current financial assets and cash equivalents include collective investment funds
denominated in € and $ of which the underlying investments include bonds and other international debt securities. Based
on the weighted average maturity of the underlying instruments, amongst others, these investments are either classified
as current financial assets or cash equivalents.
The maximum exposure to credit risk is the carrying amount at reporting date.
F-43 |
As of December 31, 2025 | |||||||||
(in thousands of $) | Level 1 | Level 2 | Level 3 | ||||||
Non-current financial assets | $ | $ | $ | ||||||
Cash and cash equivalents | |||||||||
Assets carried at fair value | $ | $ | $ | ||||||
As of December 31, 2024 | |||||||||
(in thousands of $) | Level 1 | Level 2 | Level 3 | ||||||
Non-current financial assets | $ | $ | $ | ||||||
Cash and cash equivalents | |||||||||
Assets carried at fair value | $ | $ | $ | ||||||
As of December 31, 2023 | |||||||||
(in thousands of $) | Level 1 | Level 2 | Level 3 | ||||||
Non-current financial assets | $ | $ | $ | ||||||
Cash and cash equivalents | |||||||||
Assets carried at fair value | $ | $ | $ | ||||||
During the disclosed calendar year, no
The Company owns shares of Zai Lab due to its license and collaboration agreement. The fair value shares of the equity
instrument at period-end is determined by reference to the closing price of such securities at each reporting date
(classified as level 1 in the fair value hierarchy), resulting in a change in fair value. The Company made the irrevocable
election to recognize subsequent changes in fair value through OCI.
The Company has a profit share in AgomAb Therapeutics NV which is a non-publicly listed company valued using
certain unobservable inputs and assumptions.
The changes in the value of these investments are detailed in ‘‘Note 6 — Other Non-Current Assets”.
The Company manages its capital to ensure that it will be able to continue as a going concern. The capital structure of
the Company consists of equity attributed to the holders of equity instruments of the Company, such as capital, reserves
and accumulated losses as mentioned in the consolidated statements of changes in equity. The Company makes the
necessary adjustments in light of changes in the economic circumstances, risks associated to the different assets and the
projected cash needs of the current and projected research activities. On December 31, 2025, cash and cash equivalents
amounted to $3.5 billion current financial assets amounted to $0.9 billion and total capital amounted to $7.3 billion. The
current cash situation and the anticipated cash generation and usage are the most important parameters in assessing the
capital structure. The Company’s objective is to maintain the capital structure at a level to be able to finance its activities
for at least twelve months. Cash income from operations is taken into account and, if needed and possible, the Company
can enter into financing agreements or issue new shares.
Credit risk refers to the risk that a counterparty will default on its contractual obligations resulting in financial loss to the
Company. The Company has adopted a policy of only dealing with creditworthy counterparties and obtaining sufficient
collateral, where appropriate, as a means of mitigating the risk of financial loss from defaults. Concentrations in credit
risk are determined based on an analysis of counterparties and their importance on the overall outstanding contractual
obligations at year-end.
The Company's commercial revenue are concentrated as discussed in “Note 16 — Segment Reporting”, on a limited
number of U.S. customers with high quality creditworthiness. The Company sets customer specific credit limits in order
to reduce credit risk from commercial payors.
F-44 |
The Company applied the IFRS 9 simplified approach to measuring expected credit losses which uses a lifetime
expected loss allowance for trade receivables. To measure the expected credit losses, receivables have been grouped
based on credit risk characteristics and the days past due. The provision for expected credit losses was not significant
given that there have been no credit losses over the last three years and the high quality nature of the Company’s
customers.
Cash and cash equivalents and current financial assets are invested with several highly reputable banks and financial
institutions. The main purpose of the Cash Investment Policy is to preserve the available cash and to ensure sufficient
short-term liquidity at all times. Therefore, the Company holds its cash and cash equivalents, in addition to current
financial assets mainly with banks which are independently rated A- or higher. Amounts of cash held with banks rated
lower than A- are limited to insignificant balances. The maximum amount and tenor of term accounts depends on the
rating of the counterparty bank. The Company also holds cash equivalents in the form of money market funds with a low
historical volatility. These money market funds are highly liquid investments and can be readily convertible into a
known amount of cash. The company has adopted a policy whereby money market funds must have a minimum rating of
A, and whereby 95% of its money market funds should have a AAA-rating.
The Company manages liquidity risk by maintaining adequate reserves, by continuously monitoring forecast and actual
cash flows, and by matching the maturity profile of financial assets and liabilities.
The Company’s main sources of cash are the sale of commercial product and exercise of stock options. This cash is
invested in savings accounts, term accounts and money market funds. These money market funds represent the majority
of the Company’s available sources of liquidity. Since all of these are immediately tradable and convertible in cash they
have an important mitigating effect on any short-term liquidity risk.
As of December 31, 2025, the Company had lines of credit totaling $29 million with financial institutions mainly
relating to leasing guarantees.
The only variable interest-bearing financial instruments are cash and cash equivalents and current financial assets.
Changes in interest rates may cause variations in interest income resulting from short-term interest-bearing assets. Lower
short-term interests may have a negative impact on the interest income of the Company.
For the year ended December 31, 2025, if applicable interest rates would increase/decrease by 50 basis points, this would
have a positive/negative impact of $22 million (compared to $8 million for the year ended December 31, 2024 and $8
million for the year ended December 31, 2023if applicable interest rates would increase/decrease by 25
The Company undertakes transactions denominated in foreign currencies, causing exposures to exchange rate
fluctuations. The Company is mainly exposed to the Euro, Japanese yen, British pound and Swiss franc. To limit this
risk, the Company attempts to align incoming and outgoing cash flows in currencies other than USD. The Company
further limits its non-USD liquidity holdings when possible.
current financial assets) of the Company at the end of the reporting period are as follows:
As of December 31, | ||||||
(in thousands of $) | 2025 | 2024 | 2023 | |||
EUR | ||||||
Other currencies | ||||||
On December 31, 2025, if the EUR would have strengthened/weakened versus the USD by 10
negative/positive impact of $16 76 92
December 31, 2023, respectively. If other currencies would have strengthen or weakened against the USD by 10
would have had no significant impact in all reported periods.
F-45 |
In 2022, the University of Colorado Anschutz Medical Campus and the University of Colorado Health (UCHealth)
created an asset-centric spin-off, OncoVerity, Inc (OncoVerity), focused on optimizing and advancing the development
of cusatuzumab, a novel anti-CD70 antibody, in AML. OncoVerity is an entity of co-creation, combining the extensive
translational biology insights from Dr. Clayton Smith, M.D. from the University of Colorado with our experience on the
CD70/CD27 pathway. argenx contributed $7 million in 2025 ($7 million and $13 million in 2024 and 2023
respectively).
The investment has been accounted under IAS 28 Investment in associates and Joint Ventures using the equity method of
accounting and has been designated as an “Investment in a joint venture” in the consolidated statements of financial
position. The share of net loss resulting from investment in joint ventures is presented in consolidated statements of
profit or loss as “Loss from investment in a joint venture”. The cash contributions made by the Company to the Joint
Venture is reported under Cash flow from investing activities under “Investment in a joint venture”.
See ‘‘Note 29 — Overview of Consolidation Scope’’ for an overview of the consolidated companies of the group, which
are all wholly-owned subsidiaries of argenx SE.
Balances and transactions between the Company and its subsidiaries, which are related parties of the Company, have
been eliminated on consolidation and are not disclosed in this note.
The Company’s key management personnel consists of the members of the management team and the members of the
board of directors.
Remuneration of key management personnel
On December 31, 2025, the Senior Management Team consisted of eight members: Chief Executive Officer, Chief
Operating Officer, Chief Financial Officer, Chief Scientific Officer, General Counsel, Chief Medical Officer, Vice
President Corporate Development and Strategy and Global Head of Quality Assurance. They provide their services on a
full-time basis.
On December 31, 2025, the board of directors consisted of eight Non-Executive Directors: Peter Verhaeghe, Pamela
Klein, Anthony Rosenberg, James Daly, Camilla Sylvest, Ana Céspedes, Steve Krognes, Brian Kotzin, and one
executive director, Tim Van Hauwermeiren.
Only the CEO is a member of both the Senior Management Team and the Board of Directors. The CEO does not receive
any remuneration for his membership of the Board of Directors, as this is part of his total remuneration package in his
capacity as member of the Senior Management Team.
F-46 |
Year Ended December 31, | |||||||||
(in thousands of $, except for the number of stock options & RSUs) | 2025 | 2024 | 2023 | ||||||
Remuneration of key management personnel | |||||||||
Short-term benefits for the Senior Management Team | |||||||||
Gross salary | $ | $ | $ | ||||||
Variable pay | |||||||||
Employer social security | |||||||||
Other short term benefits | |||||||||
Post-employment benefits for the Senior Management | |||||||||
Cost of stock options granted in the year for the Senior Management Team | |||||||||
Cost of restricted stock units granted in the year for the Senior Management Team | |||||||||
Cost of performance stock units granted in the year for | |||||||||
Employer social security cost related to stock options | ( | ||||||||
Total benefits for key management personnel | |||||||||
Numbers of stock options granted in the year | |||||||||
Senior Management Team | |||||||||
Numbers of restricted stock units granted in the year | |||||||||
Senior Management Team | |||||||||
Numbers of performance stock units granted in the year | |||||||||
Senior Management Team | |||||||||
Remuneration of Non-Executive Directors | |||||||||
Board fees and other short-term benefits for Non- | |||||||||
Cost of stock options granted in the year for Non- | |||||||||
Cost of restricted stock units granted in the year for Non- Executive Directors | |||||||||
Total benefits for Non-Executive Directors | $ | $ | $ | ||||||
Numbers of stock options granted in the year | |||||||||
Non-Executive Directors | |||||||||
Numbers of restricted stock units granted in the year | |||||||||
Non-Executive Directors | |||||||||
Other
No loans, quasi-loans or other guarantees were given by the Company or any of its subsidiaries to members of the Senior
Management Team or the Board of Directors. We have not entered into transactions with the Company’s key
management personnel, other than as described above with respect to remuneration arrangements relating to the exercise
of their mandates as members of the Senior Management Team and the Board of Directors.
The Company is currently not facing any outstanding claims or litigation that may have a significant adverse impact on
the Company’s consolidated financial position.
In February 2019, the Company entered into a global collaboration and license agreement with Halozyme Therapeutics,
which was later amended in September 2020 and again in September 2024.
Under the terms of the agreement, the Company will pay up to $40 million to achievement of specific regulatory and
sales-based milestones related specifically to its FcRn target. This amount represents the maximum amount that would
be paid if all milestones would be achieved but excludes variable royalty payments based on unit sales.
F-47 |
Further, the Company will pay up to $78 million per other non-FcRn target subject to achievement of specified
development, regulatory and sales-based milestones. This amount represents the maximum amount that would be paid
per target if all milestones would be achieved but excludes variable royalty payments based on unit sales. The Company
has a total of six nominated targets under this agreement including its FcRn target.
The Company’s commercial supply is manufactured in collaboration with Lonza and Fujifilm. In the aggregate, the
Company has outstanding commitments for efgartigimod under these commercial supply agreements amounting to
approximately $1.3 billion. These agreements provide commercial supply of efgartigimod to the Company’s global
commercial operations through facilities in the U.S., Europe and Asia.
statements of other comprehensive income or loss:
Year Ended December 31, | |||||||||
Fees (in thousands of $) | 20251) | 20242) | 20232) | ||||||
Audit fees | $ | $ | $ | ||||||
Audit-related fees | |||||||||
Total | $ | $ | $ | ||||||
1)Audit services performed by EY Accountants B.V. as the external auditor in 2025 referred to in Section 1 of the Dutch Accounting Firms
Oversight Act (Wta) as well as by the EY network.. In 2025, audit and audit related fees of EY Accountants B.V. (excluding its member firms
and/or affiliates) amounted to $973 and $677 , respectively.
2)Audit services performed by Deloitte Accountants B.V. as the external auditor referred to in Section 1 of the Dutch Accounting Firms Oversight
Act (Wta) as well as by the Deloitte network
At the meeting held on May 7, 2024, the Company’s general assembly of shareholders appointed EY Accountants B.V.
as external auditor for the financial year ending December 31, 2025. Deloitte Accountants B.V. completed its mandate as
external auditor as of the financial year ending December 31, 2024.
F-48 |
The parent company argenx SE is domiciled in the Netherlands. The Company, argenx SE, has one subsidiary, argenx
BV, which is based in Belgium. argenx BV has sixteen subsidiaries. Details of the Company’s consolidated entities at
the end of the reporting period are as follows:
Name | Country | Participation | ||
argenx SE | the Netherlands | |||
argenx B.V. | Belgium | |||
argenx Benelux B.V. | Belgium | |||
argenx US, Inc. | USA | |||
argenx Australia Pty. Ltd. | Australia | |||
argenx Austria Services GmbH | Austria | |||
argenx Brasil Produtos Farmacêuticos Ltda | Brazil | |||
argenx Canada Inc. | Canada | |||
argenx France SAS | France | |||
argenx Germany GmbH | Germany | |||
argenx Italy S.r.l. | Italy | |||
argenx Japan KK. | Japan | |||
argenx Netherlands Services B.V. | the Netherlands | |||
argenx Spain S.L. | Spain | |||
argenx Spain S.L. - Sucursal em Portugal | Portugal | |||
argenx Switzerland, S.A. | Switzerland | |||
argenx UK Ltd. | United Kingdom | |||
Broteio Pharma B.V. | the Netherlands |
No events have occurred after the balance sheet date that could have a material impact on the consolidated financial
statements.
