Argenx SE 6-K, filed Jul 25, 2024
Argenx SE (ARGX)
About this 6-K
Argenx SE filed this 6-K on July 25, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of July 2024
Commission File Number: 001-38097
ARGENX SE
(Translation of registrant’s name into English)
Laarderhoogtweg 25
1101 EB Amsterdam, the Netherlands
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ⌧ Form 40-F ◻
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ◻
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ◻
argenx SE
On July 25, 2024, argenx SE (the “Company) issued a press release and unaudited first half-year financial results for 2024, which are further described in an Unaudited Interim Report for the Six Months Ended June 30, 2024, copies of which are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated by reference herein.
The information contained in this Current Report on Form 6-K, including Exhebit 99.1 and Exhebit 99.2, shall be deemed to be incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-258251 and S-8 (File Nos. 333-225375, 333-258253, and 333-274721), and to be part thereof from the date on which this Current Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBITS
Exhibit | | Description |
| | |
99.1 | | |
| | |
99.2 | | Unaudited Interim Report for the Six Months Ended June 30, 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) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| ARGENX SE | |
| | |
Date: July 25, 2024 | By: | /s/ Hemamalini (Malini) Moorthy |
| | Hemamalini (Malini) Moorthy |
| | General Counsel |
Ex* reflects cash, cash equivalents and current financial assets
hibit 99.1
argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update
$478 million in second quarter global net product sales
First CIDP patients treated with VYVGART® Hytrulo following June 21st FDA approval
On track to begin four additional registrational studies across efgartigimod and empasiprubart by end of 2024
Management to host conference call today at 2:30 PM CET (8:30 AM ET)
July 25, 7:00 AM CET
Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its half year 2024 results and provided a second quarter business update.
“We were excited to unveil our ambition for the future of argenx – Vision 2030 – last week, outlining our plan to develop and deliver continued and sustainable innovation for patients,” said Tim Van Hauwermeiren, Chief Executive Officer, argenx. “We are already delivering on this promise with impressive commercial execution throughout the first half of the year, expanding our patient reach in MG, and launching in CIDP with our broad FDA label. Our development pipeline is stronger than ever, driven by our unique innovation engine. And we are well-positioned to capture the sizeable growth opportunity before us as we seek to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe.”
Vision 2030
During its R&D Day on July 16, 2024, argenx unveiled its ‘Vision 2030’ as part of its long-term commitment to transform the treatment of autoimmune diseases by strengthening its leadership in neonatal Fc receptor (FcRn) biology, investing in its continuous pipeline of differentiated antibody candidates, and scaling in a disciplined way to ensure innovation remains core to the argenx mission. ‘Vision 2030’ includes the following goals:
| ● | 50,000 patients globally on treatment with an argenx medicine |
| ● | 10 labeled indications across all approved assets, including VYVGART franchise and potentially empasiprubart and ARGX-119 |
| ● | Five new molecules in Phase 3 development indicating ongoing investment in internal discovery engine, the Immunology Innovation Program |
Reaching 50,000 Patients Globally
VYVGART (efgartigimod alfa-fcab) is a first-in-class antibody fragment targeting FcRn and is now approved for both intravenous use and subcutaneous injection (SC) (efgartigimod alfa and hyaluronidase-qvfc) in three indications, including generalized myasthenia gravis (gMG) globally, primary immune thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S.
| ● | Generated global net product sales (inclusive of both VYVGART and VYVGART SC) of $478 million in second quarter of 2024 |
| ● | National Medical Products Administration (NMPA) approved VYVGART SC for treatment of gMG in China through Zai Lab on July 16, 2024 |
| ● | Additional VYVGART regulatory decisions on approval expected for gMG in 2024, including in Switzerland, Australia, and Saudi Arabia |
| ● | Launched VYVGART Hytrulo in CIDP in U.S. with first patients injected in July |
| ● | Multiple VYVGART SC regulatory submissions under review or planned for CIDP, including: |
| o | Regulatory submissions completed in China, Japan, and Europe with decisions on approval expected in 2025 |
| o | Regulatory submission filing in Canada by end of 2024 |
| ● | Announced plan to evaluate VYVGART in ocular MG with registrational study (ADAPT OCULUS) to start by end of year; OCULUS to support label-expansion strategy into broader MG populations along with ongoing ADAPT SERON study in seronegative MG |
| ● | Regulatory submission filed and under regulatory review for VYVGART SC pre-filled syringe (PFS) for gMG and and CIDP |
Advancing Pipeline to Achieve 10 Labeled Indications by 2030
argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple pipeline-in-a-product candidates. argenx is solidifying its leadership in FcRn biology, with efgartigimod currently in development in 15 indications. argenx is also advancing its first-in-class C2 inhibitor, empasiprubart, which is being evaluated in multifocal motor neuropathy (MMN), delayed graft function (DGF), dermatomyositis (DM), and CIDP. In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).
| ● | Registrational studies ongoing of efgartigimod in thyroid eye disease (TED) |
| ● | Advancing development of efgartigimod in primary Sjogren’s disease (SjD) with Phase 3 study to begin by end of 2024 |
| ● | Following alignment meeting with FDA, confirmatory study of VYVGART (IV) in primary ITP to start by end of 2024 to enable registration in U.S. |
| ● | Topline data from seamless Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and DM expected in fourth quarter of 2024 |
| ● | Update on BALLAD study development plan evaluating efgartigimod in bullous pemphigoid (BP) expected by end of 2024 |
| ● | Proof-of-concept studies ongoing with efgartigimod in membranous nephropathy (MN) and lupus nephritis (LN) with studies expected to initiate this year in antibody mediated rejection (AMR) and systemic sclerosis (SSc) |
| ● | Phase 3 study of empasiprubart for MMN to initiate in fourth quarter of 2024 |
| ● | CIDP nominated as fourth empasiprubart indication, recognizing opportunity to bring multiple innovative treatments to patients |
| ● | Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS to start by end of 2024 |
Investing in Immunology Innovation Program to Support Five New Molecules in Phase 3 by 2030
argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx’s leadership in this new class of medicine; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and ARGX-220, a first-in-class sweeping antibody for which the target has not yet been disclosed.
| ● | Phase 1 studies of ARGX-213 and ARGX-121 expected to start in second half of 2025 |
| ● | Investigational new drug (IND) applications for ARGX-220 and ARGX-109 on track to be filed by end of 2025 |
SECOND QUARTER 2024 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
(in thousands of $ except for shares and EPS) | 2024 | 2023 | 2024 | 2023 | |||||||||
Product net sales |
| $ | 477,635 | | $ | 269,313 | | $ | 875,918 | | $ | 487,335 | |
Collaboration revenue | - | | | 1,237 | | | 2,718 | | | 2,355 | |||
Other operating income |
| 11,793 | | | 10,485 | | | 23,305 | | | 21,225 | ||
Total operating income | $ | 489,428 | | $ | 281,035 | | $ | 901,941 | | $ | 510,915 | ||
|
| | | | | | | | | | | ||
Cost of sales | $ | (52,383) | | $ | (24,024) | | $ | (95,561) | | $ | (42,359) | ||
Research and development expenses |
| (225,286) | | | (195,509) | | | (450,255) | | | (361,364) | ||
Selling, general and administrative expenses | (255,699) | | | (161,977) | | | (491,694) | | | (311,149) | |||
Loss from investment in joint venture |
| (1,521) | | | (1,619) | | | (3,313) | | | (1,880) | ||
Total operating expenses | $ | (534,889) | | $ | (383,129) | | $ | (1,040,823) | | | (716,752) | ||
|
| | | | | | | | | | | ||
Operating loss | $ | (45,461) | | $ | (102,094) | | $ | (138,882) | | $ | (205,837) | ||
|
| | | | | | | | | | | ||
Financial income | $ | 38,933 | | $ | 20,441 | | $ | 77,828 | | $ | 37,029 | ||
Financial expense |
| (572) | | | (207) | | | (1,084) | | | (395) | ||
Exchange gains/(losses) | (7,903) | | | (2,001) | | | (27,215) | | | 9,164 | |||
|
| | | | | | | | | | | ||
Loss for the period before taxes | $ | (15,003) | | $ | (83,861) | | $ | (89,353) | | $ | (160,039) | ||
Income tax benefit/(expense) |
| $ | 44,069 | | $ | (10,507) | | $ | 56,822 | | $ | 36,800 | |
Profit/(loss) for the period | $ | 29,066 | | $ | (94,368) | | $ | (32,531) | | $ | (123,239) | ||
Profit/(loss) for the period attributable to: |
| | | | | | | | | | | ||
Owners of the parent | $ | 29,066 | | $ | (94,368) | | $ | (32,531) | | $ | (123,239) | ||
Weighted average number of shares outstanding |
| 59,490,437 | | | 55,828,239 | | | 59,400,217 | | | 55,690,873 | ||
Basic profit/(loss) per share (in $) | 0.49 | | | (1.69) | | | (0.55) | | | (2.21) | |||
Diluted profit/(loss) per share (in $) |
| 0.45 | | | (1.69) | | | (0.55) | | | (2.21) | ||
Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2022 and 2023 | | | | | | | (77,497) | | $ | (195,580) | |||
Cash and cash equivalents and current financial assets at the end of the period |
| | | | | | | 3,102,347 | | $ | 1,996,968 | ||
DETAILS OF THE FINANCIAL RESULTS
Total operating income for the three and six months ended June 30, 2024 was $489 million and $902 million compared to $281 million and $511 million for the same periods in 2023, and mainly consists of:
Total operating expenses for the three and six months ended June 30, 2024 were $535 million and $1,041 million compared to $383 million and $717 million for the same periods in 2023, and mainly consists of:
| ● | Cost of sales for the three and six months ended June 30, 2024 was $52 million and $96 million compared to $24 million and $42 million for the same periods in 2023. The cost of sales was recognized with respect to the sale of VYVGART and VYVGART SC. |
| ● | Research and development expenses for the three and six months ended June 30, 2024 were $225 million and $450 million compared to $196 million and $361 million for the same periods in 2023. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of other clinical and preclinical pipeline candidates. |
| ● | Selling, general and administrative expenses for the three and six months ended June 30, 2024 were $256 million and $492 million compared to $162 million and $311 million for the same periods in 2023. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART and VYVGART SC, and personnel expenses. |
Financial income for the three and six months ended June 30, 2024, was $39 million and $78 million compared to $20 million and $37 million for the same periods in 2023. The increase in financial income is mainly due to an increase in interest income coming from an increase of cash, cash equivalents and current financial assets as a result of the July 2023 financing round.
Exchange losses for the three and six months ended June 30, 2024, were $8 million and $27 million compared to $2 million exchange losses and $9 million of exchange gains for the same periods in 2023. Exchange gains/losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current financial assets denominated in Euro.
Income tax for the three and six months ended June 30, 2024, was $44 million and $57 million of income tax benefit, respectively, compared to $11 million of income tax expense and $37 million of income tax benefit for the same periods in 2023.
Net Result for the three and six months ended June 30, 2024, was $29 million profit and $33 million loss compared to $94 million and $123 million loss for the same periods in 2023. On a per weighted average share basis, the basic profit was $0.49 and diluted profit was $0.45 for the three months ended June 30, 2024, compared to a basic and diluted loss of $1.69 for the same period in 2023. On a per weighted average share basis, the basic and diluted loss was $0.55 for the six months ended June 30, 2024, compared to a basic and diluted loss of $2.21 for the same period in 2023.
Cash, cash equivalents and current financial assets totalled $3.1 billion as of June 30, 2024, compared to $3.2 billion as of December 31, 2023. The decrease in cash and cash equivalents and current financial assets result from a net cash flows used in operating activities.
FINANCIAL GUIDANCE
Based on its current operating plans, argenx expects its combined research and development and selling, general and administrative expenses in 2024 to be less than $2 billion. argenx updated its cash burn guidance and now expects to utilize less than $500 million of net cash* iin 2024 on anticipated operating expenses as well as working capital and capital expenditures.
EXPECTED 2024 FINANCIAL CALENDAR
| ● | October 31, 2024: 3Q 2024 financial results and business update |
| ● | February 27, 2025: Full-year 2024 financial results and 4Q 2024 business update |
CONFERENCE CALL DETAILS
The half-year 2024 financial results and second quarter business update will be discussed during a conference call and webcast presentation today at 2:30 PM CET/8:30 AM ET. A webcast of the live call and replay may be accessed on the Investors section of the argenx website at argenx.com/investors.
Dial-in numbers:
Please dial in 15 minutes prior to the live call.
Belgium32 800 50 201
France33 800 943355
Netherlands31 20 795 1090
United Kingdom44 800 358 0970
United States 1 800 715 9871
Japan81 3 4578 9081
Switzerland41 43 210 11 32
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker, globally in the U.S., Japan, Israel, the EU, the UK, China and Canada. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube.
For further information, please contact:
Media:
Ben Petok
bpetok@argenx.com
Investors:
Alexandra Roy (US)
aroy@argenx.com
Lynn Elton (EU)
lelton@argenx.com
Forward-looking Statements
The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “advance,” “aim,” “anticipates,” “continue,” “expect,” “expand,” “plan,” or “seek” and include statements argenx makes regarding its Vision 2030 plan to develop and deliver continued and sustainable innovation for patients; its long-term commitments; its Vision 2030 goals, including having 50,000 patients globally on treatment with an argenx medicine, 10 labeled indications across all approved assets, including VYVGART franchise and potentially empasiprubart and ARGX-119, and five new molecules in Phase 3 development indicating ongoing investment in the immunology innovation program; its growth opportunity; its plans to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe; the advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the anticipated timing of four additional Phase 3 registrational studies across efgartigimod and empasiprubart, the expected timing of additional VYVGART regulatory decisions on approval for gMG, including in Switzerland, Australia, and Saudi Arabia, the expected timing of additional VYVGART SC regulatory submissions under review or planned for CIDP, including decisions on approval in China, Japan, and Europe and a regulatory submission filing in Canada, the anticipated timing of the initiation of a Phase 3 study for efgartigimod in primary Sjogren’s disease (SjD), the anticipated timing of a confirmatory study of VYVGART (IV) in primary ITP, the anticipated timing of topline data from Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets, the anticipated timing of an update on BALLAD study development plan evaluating efgartigimod in BP, the anticipated timing of proof-of-concept studies for efgartigimod in AMR and SSc, the anticipated timing of the initiation of a Phase 3 study of empasiprubart for MMN, the anticipated timing of the initiation of Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS, the anticipated timing of the initiation of Phase 1 studies of ARGX-213 and ARGX-121; its investigational new drug applications for ARGX-2220 and ARGX-109 expected to be filed by the end of 2025; its 2024 research and development and selling, general and administrative expenses and operating expenses; its 2024 cash burn; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third parties suppliers, service provides and manufacturing; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.
i reflects cash, cash equivalents and current financial assets
TABLE OF CONTENTS
MANAGEMENT REPORT
1. | MAIN EVENTS IN THE SIX MONTHS OF 2024 |
FIRST QUARTER OF 2024
See refer to our Q1 2024 press release
SECOND QUARTER OF 2024 AND RECENT BUSINESS UPDATE
“We were excited to unveil our ambition for the future of argenx – Vision 2030 – last week, outlining our plan to develop and deliver continued and sustainable innovation for patients,” said Tim Van Hauwermeiren, Chief Executive Officer, argenx. “We are already delivering on this promise with impressive commercial execution throughout the first half of the year, expanding our patient reach in MG, and launching in CIDP with our broad FDA label. Our development pipeline is stronger than ever, driven by our unique innovation engine. And we are well-positioned to capture the sizeable growth opportunity before us as we seek to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe.”
Vision 2030
During its R&D Day on July 16, 2024, argenx unveiled its ‘Vision 2030’ as part of its long-term commitment to transform the treatment of autoimmune diseases by strengthening its leadership in neonatal Fc receptor (FcRn) biology, investing in its continuous pipeline of differentiated antibody candidates, and scaling in a disciplined way to ensure innovation remains core to the argenx mission. ‘Vision 2030’ includes the following goals:
| ● | 50,000 patients globally on treatment with an argenx medicine |
| ● | 10 labeled indications across all approved assets, including VYVGART franchise and potentially empasiprubart and ARGX-119 |
| ● | Five new molecules in Phase 3 development indicating ongoing investment in internal discovery engine, the Immunology Innovation Program |
Reaching 50,000 Patients Globally
VYVGART (efgartigimod alfa-fcab) is a first-in-class antibody fragment targeting FcRn and is now approved for both intravenous use and subcutaneous injection (SC) (efgartigimod alfa and hyaluronidase-qvfc) in three indications, including generalized myasthenia gravis (gMG) globally, primary immune thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S.
| ● | Generated global net product sales (inclusive of both VYVGART and VYVGART SC) of $876 million in the first six months of 2024 |
| ● | National Medical Products Administration (NMPA) approved VYVGART SC for treatment of gMG in China through Zai Lab on July 16, 2024 |
| ● | Additional VYVGART regulatory decisions on approval expected for gMG in 2024, including in Switzerland, Australia, and Saudi Arabia |
| ● | Launched VYVGART Hytrulo in CIDP in U.S. with first patients injected in July |
| ● | Multiple VYVGART SC regulatory submissions under review or planned for CIDP, including: |
| o | Regulatory submissions completed in China, Japan, and Europe with decisions on approval expected in 2025 |
| o | Regulatory submission filing in Canada by end of 2024 |
| ● | Announced plan to evaluate VYVGART in ocular MG with registrational study (ADAPT OCULUS) to start by end of year; OCULUS to support label-expansion strategy into broader MG populations along with ongoing ADAPT SERON study in seronegative MG |
| ● | Regulatory submission filed and under regulatory review for VYVGART SC pre-filled syringe (PFS) for gMG and CIDP |
2
Advancing Pipeline to Achieve 10 Labeled Indications by 2030
argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple pipeline-in-a-product candidates. argenx is solidifying its leadership in FcRn biology, with efgartigimod currently in development in 15 indications. argenx is also advancing its first-in-class C2 inhibitor, empasiprubart, which is being evaluated in multifocal motor neuropathy (MMN), delayed graft function (DGF), dermatomyositis (DM), and CIDP. In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).
| ● | Registrational studies ongoing of efgartigimod in thyroid eye disease (TED) |
| ● | Advancing development of efgartigimod in primary Sjogren’s disease (SjD) with Phase 3 study to begin by end of 2024 |
| ● | Following alignment meeting with FDA, confirmatory study of VYVGART (IV) in primary ITP to start by end of 2024 to enable registration in U.S. |
| ● | Topline data from seamless Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and DM expected in fourth quarter of 2024 |
| ● | Update on BALLAD study development plan evaluating efgartigimod in bullous pemphigoid (BP) expected by end of 2024 |
| ● | Proof-of-concept studies ongoing with efgartigimod in membranous nephropathy (MN) and lupus nephritis (LN) with studies expected to initiate this year in antibody mediated rejection (AMR) and systemic sclerosis (SSc) |
| ● | Phase 3 study of empasiprubart for MMN to initiate in fourth quarter of 2024 |
| ● | CIDP nominated as fourth empasiprubart indication, recognizing opportunity to bring multiple innovative treatments to patients |
| ● | Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS to start by end of 2024 |
Investing in Immunology Innovation Program to Support Five New Molecules in Phase 3 by 2030
argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx’s leadership in this new class of medicine; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and ARGX-220, a first-in-class sweeping antibody for which the target has not yet been disclosed.
| ● | Phase 1 studies of ARGX-213 and ARGX-121 expected to start in second half of 2025 |
| ● | Investigational new drug (IND) applications for ARGX-220 and ARGX-109 on track to be filed by end of 2025 |
| 2. | FINANCIAL HIGHLIGHTS |
Total operating income for the six months ended June 30, 2024, was $902 million compared to $511 million for the same period in 2023, and mainly consists of:
| ● | Product net sales of VYVGART and VYVGART SC for the six months ended June 30, 2024, were $876 million compared to $487 million for the same period in 2023. |
| ● | Other operating income for the six months ended June 30, 2024, was $23 million compared to $21 million for the same period in 2023. The other operating income for the six months ended June 30, 2024 and 2023, primarily relates to research and development tax incentives. |
Total operating expenses for the six months ended June 30, 2024 were $1,041 million compared to $717 million for the same period in 2023, and mainly consists of:
| ● | Cost of sales for the six months ended June 30, 2024, was $96 million compared to $42 million for the same period in 2023. The cost of sales was recognized with respect to the sale of VYVGART and VYVGART SC. |
3
| ● | Research and development expenses for the six months ended June 30, 2024, were $450 million compared to $361 million for the same period in 2023. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of other clinical and preclinical pipeline candidates. |
| ● | Selling, general and administrative expenses for the six months ended June 30, 2024, were $492 million compared to $311 million for the same period in 2023. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART and VYVGART SC, and personnel expenses. |
Financial income for the six months ended June 30, 2024, was $78 million compared to $37 million for the same period in 2023. The increase in financial income is mainly due to an increase in interest income coming from an increase of cash, cash equivalents and current financial assets as a result of the July 2023 financing round.
Exchange losses for the six months ended June 30, 2024, were $27 million compared to $9 million of exchange gains for the same period in 2023. Exchange gains/losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current financial assets denominated in Euro.
Income tax for the six months ended June 30, 2024, was $57 million of income tax benefit compared to $37 million of income tax benefit for the same period in 2023. Income tax benefit for the six months ended June 30, 2024, consists of $16 million of current income tax expense and $73 million of deferred tax benefit, compared to $23 million of current income tax expense and $59 million of deferred tax benefit for the comparable prior period.
Loss for the six months ended June 30, 2024 was $33 million compared to $123 million for the same period in 2023. On a per weighted average share basis, the basic loss per share was $0.55 and $2.21 for the six months ended June 30, 2024 and 2023, respectively.
Cash, cash equivalents and current financial assets totalled $3.1 billion as of June 30, 2024, compared to $3.2 billion as of December 31, 2023. The decrease in cash and cash equivalents and current financial assets result from net cash flows used in operating activities.
| 3. | RISK FACTORS |
We refer to the description of risk factors in the 2023 annual report, pp. 97-143 as supplemented by the description of risk factors in our annual report on Form 20-F filed with the U.S. Securities and Exchange Commission, pp. 1-39. In summary, the principal risks and uncertainties faced by us relate to: our financial position and need for additional capital, commercialization of our products and product candidates, including new indications, government regulations, development and clinical testing of our products and product candidates, dependence on third parties, business and industry, intellectual property, our organization and operations.
We also refer to the description of our financial risk management given in the 2023 annual report, pp. F40-F44, which remains valid.
| 4. | FORWARD-LOOKING STATEMENTS |
The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “advance,” “aim,” “anticipates,” “continue,” “expect,” “expand,” “plan,” or “seek” and include statements argenx makes regarding its Vision 2030 plan to develop and deliver continued and sustainable innovation for patients; its long-term commitments; its Vision 2030 goals, including having 50,000 patients globally on treatment with an argenx medicine, 10 labeled indications across all approved assets,
4
including VYVGART franchise and potentially empasiprubart and ARGX-119, and five new molecules in Phase 3 development indicating ongoing investment in the immunology innovation program; its growth opportunity; its plans to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe; the advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the anticipated timing of four additional Phase 3 registrational studies across efgartigimod and empasiprubart, the expected timing of additional VYVGART regulatory decisions on approval for gMG, including in Switzerland, Australia, and Saudi Arabia, the expected timing of additional VYVGART SC regulatory submissions under review or planned for CIDP, including decisions on approval in China, Japan, and Europe and a regulatory submission filing in Canada, the anticipated timing of the initiation of a Phase 3 study for efgartigimod in primary Sjogren’s disease (SjD), the anticipated timing of a confirmatory study of VYVGART (IV) in primary ITP, the anticipated timing of topline data from Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets, the anticipated timing of an update on BALLAD study development plan evaluating efgartigimod in BP, the anticipated timing of proof-of-concept studies for efgartigimod in AMR and SSc, the anticipated timing of the initiation of a Phase 3 study of empasiprubart for MMN, the anticipated timing of the initiation of Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS, the anticipated timing of the initiation of Phase 1 studies of ARGX-213 and ARGX-121; its investigational new drug applications for ARGX-2220 and ARGX-109 expected to be filed by the end of 2025; its 2024 research and development and selling, general and administrative expenses and operating expenses; its 2024 cash burn; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third parties suppliers, service provides and manufacturing; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.
STATEMENT OF THE BOARD OF DIRECTORS
We hereby certify that, to the best of our knowledge, the unaudited condensed consolidated interim financial statements of argenx SE as of and for the six months ended June 30, 2024, prepared in accordance with IAS 34 “Interim Financial Reporting” as issued by the IASB and as adopted by the European Union, gives a true and fair view of the assets, liabilities, financial position and total comprehensive income of the Company and the undertakings included in the consolidation as a whole, and that the management report includes a fair review of the development and performance of the business and the position of the Company and the undertakings included in the consolidation taken as a whole, together with a description of the principal risks and uncertainties that they face.
On behalf of the Board of Directors
Tim van Hauwermeiren, CEO
5
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
ARGENX SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
| | | | As of | ||||
| | | | June 30, | | December 31, | ||
(in thousands of $) |
| Note |
| 2024 |
| 2023 | ||
ASSETS |
|
| |
|
|
|
|
|
Non‑current assets |
|
| | |
|
| | |
Property, plant and equipment |
| | | $ | |
| $ | |
Intangible assets |
| | | | |
| | |
Deferred tax asset | | 14 | | | | | | |
Research and development incentive receivables |
| | | | |
| | |
Investment in joint venture | | | | | | | | |
Prepaid expenses | | | | | | | | |
Other non-current assets | | 4 | | | | | | |
Total non‑current assets |
|
| | | |
| | |
| | | | | | | | |
Current assets |
|
| | |
|
| |
|
Inventories | | 5 | | $ | | | $ | |
Prepaid expenses |
| | | | |
| | |
Trade and other receivables | | 6 | | | | | | |
Research and development incentive receivables |
| | | | |
| | |
Financial assets |
| | | | |
| | |
Cash and cash equivalents |
| 7 | | | |
| | |
Total current assets |
| | | | |
| | |
| | | | | | | | |
TOTAL ASSETS |
|
| | $ | |
| $ | |
The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements
6
| | | | As of | ||||
| | | | June 30, | | December 31, | ||
(in thousands of $) |
| Note |
| 2024 |
| 2023 | ||
EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
|
Equity |
| 8 |
| |
|
| |
|
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 | | | | | | | | |
Deferred tax liabilities | | 14 | | | | | | |
Total non-current liabilities | |
| | | | | | |
| |
| | |
| | |
|
Current liabilities |
|
|
| | |
| | |
Lease liabilities | | | | | | | | |
Trade and other payables |
| 10 |
| | |
| | |
Tax liabilities | | | | | | | | |
Total current liabilities | |
| | | | | | |
| |
| | | | | | |
Total liabilities |
|
|
| $ | |
| $ | |
| | | | | | | | |
TOTAL EQUITY AND LIABILITIES |
|
|
| $ | |
| $ | |
The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.
7
ARGENX SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS
| | | | Six Months Ended | ||||
| | | | June 30, | ||||
(in thousands of $ except for shares and EPS) |
| Note |
| 2024 |
| 2023 | ||
Product net sales | | 11 | | $ | | | $ | |
Collaboration revenue | | | | | | | | |
Other operating income |
| |
| | |
| | |
Total operating income |
|
|
| | |
| | |
| | | | | | | | |
Cost of sales | | | | | ( | | | ( |
Research and development expenses |
| 12 |
| | ( |
| | ( |
Selling, general and administrative expenses |
| 13 |
| | ( |
| | ( |
Loss from investment in joint venture | | | | | ( | | | ( |
Total operating expenses | | | | | ( | | | ( |
| | | | | | | | |
Operating loss |
| |
| $ | ( |
| $ | ( |
| | | | | | | | |
Financial income |
| |
| | |
| | |
Financial expense | | | | | ( | | | ( |
Exchange gains/(losses) |
| |
| | ( |
| | |
| | | | |
| | |
|
Loss for the period before taxes |
| |
| $ | ( |
| $ | ( |
Income tax benefit |
| 14 |
| $ | |
| $ | |
Loss for the period |
| |
| $ | ( |
| $ | ( |
Loss for the period attributable to: | | | | | | | | |
Owners of the parent | | | | | ( | | $ | ( |
Weighted average number of shares outstanding |
|
|
| | |
| | |
Basic and diluted (loss) per share (in $) |
| |
| | ( |
| | ( |
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
8
ARGENX SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
| | | | Six Months Ended | ||||
| | | | June 30, | ||||
(in thousands of $) |
| Note |
| 2024 |
| 2023 | ||
Loss for the period |
| |
| $ | ( |
| $ | ( |
| | | | | | | | |
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 to profit or loss, net of tax | | | | | | | | |
Fair value gain/(loss) on investments in equity instruments designated as at FVTOCI | | 4 | | | ( | | | ( |
| | | | | | | | |
Other comprehensive loss, net of income tax | | | | | ( | | | ( |
| | | | | | | | |
Total comprehensive loss attributable to: | | | | | | | | |
Owners of the parent | | | | $ | ( | | $ | ( |
The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.
9
ARGENX SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
| | | | Six Months Ended | ||||
| | | | June 30, | ||||
(in thousands of $) |
| Note |
| 2024 |
| 2023 | ||
Operating loss |
|
|
| $ | ( |
| $ | ( |
Adjustments for non-cash items |
|
|
| |
|
| |
|
Amortization of intangible assets |
| |
| | |
| | |
Depreciation of property, plant and equipment |
| |
| | |
| | |
Provisions for employee benefits |
| |
| | |
| | |
Expense recognized in respect of share-based payments |
| 9 |
| | |
| | |
Fair value gains on financial assets at fair value through profit or loss | | | | | ( | | | — |
Loss from investment in joint venture | | | | | | | | |
Other non-cash expenses | | | | | | | | — |
|
|
|
| $ | ( |
| $ | ( |
Movements in current assets/liabilities |
|
|
| |
|
| |
|
(Increase)/decrease in trade and other receivables |
| 6 |
| | ( |
| | ( |
(Increase)/decrease in inventories | | 5 | | | ( | | | |
(Increase)/decrease in other current assets |
|
|
| | ( |
| | ( |
Increase/(decrease) in trade and other payables |
| 10 |
| | |
| | ( |
Movements in non-current assets/liabilities | | | | | | | | |
(Increase)/decrease in other non‑current assets |
| 4 |
| | ( |
| | ( |
(Increase)/decrease in non-current prepaid expense | | | | | — | | | ( |
| | | | | | | | |
Net cash flows used in operating activities, before interest and taxes | | | | | ( | | | ( |
| | | | | | | | |
Interest paid | | | | | ( | | | ( |
Income taxes received/(paid) | | | | | | | | ( |
| | | | | | | | |
Net cash flows used in operating activities |
|
|
| $ | ( |
| $ | ( |
| | | | | | | | |
Purchase of intangible assets |
| |
| | ( |
| | — |
Purchase of property, plant and equipment |
| |
| | ( |
| | ( |
Purchase of current financial assets | | 7 | | | ( | | | ( |
Sale of current financial assets | | 7 | | | | | | |
Interest received | | | | | | | | |
Investment in joint venture |
| |
| | — |
| | ( |
| | | | | | | | |
Net cash flows from / (used in) investing activities |
|
|
| $ | ( |
| $ | |
| | | | | | | | |
Principal elements of lease payments |
| |
| | ( |
| | ( |
Payment of employee withholding taxes relating to restricted stock unit awards | | | | | ( | | | ( |
Proceeds from exercise of stock options | | 8 | | | | | | |
| | | | | | | | |
Net cash flows from financing activities |
|
|
| $ | |
| $ | |
| | | | | | | | |
Increase/(decrease) in cash and cash equivalents |
|
|
| $ | ( |
| $ | |
| | | | | | | | |
Cash and cash equivalents at the beginning of the period |
|
|
| $ | |
| $ | |
Exchange gains/(losses) on cash and cash equivalents |
| |
| $ | ( |
| $ | |
Cash and cash equivalents at the end of the period |
|
|
| $ | |
| $ | |
The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.
10
ARGENX SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
| | Attributable to owners of the parent | |||||||||||||||||||||||
|
| | |
| | |
| | |
| | |
| Share-based |
| |
| Total |
|
| | | |||
| | | | | | | | | | | | | | payment and | | | | equity | | | | | |||
| |
| | |
| | |
| | | | | | income tax | | Fair value movement on | | attributable | | |
| | |||
| | | | | | | | | | | | | | deduction on | | investment in equity | | to owners | | | | | |||
| | Share | | Share | | Accumulated | | Translation | | share-based | | instruments designated | | of the | | | Total | ||||||||
(in thousands of $) | | capital | | premium | | losses |
| differences | | payments | | as at FVTOCI |
| parent | | | equity | ||||||||
Balance year ended December 31, 2022 |
| $ | | | | | | | ( | | | | | | | | | ( | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
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 |
| | | | | | | | | | | | | | | | | | | | |
|
| | |
Exercise of stock options |
| | | | | | | | | | | | | | | | | | | | |
|
| | |
Ordinary shares withheld for payment of employees’ withholding tax liability | | | | | | ( | | | | | | | | | | | | | | | ( | | | | ( |
| | | | | | | | | | | | | | | | | | | | | | | | | |
Balance year ended June 30, 2023 |
| $ | |
| $ | |
| $ | ( |
| $ | | | $ | | | $ | ( |
| $ | |
|
| $ | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
Balance year ended December 31, 2023 |
| $ | |
| $ | |
| $ | ( |
| $ | | | $ | | | $ | ( |
| $ | |
|
| $ | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
Loss for the period | | | | | | | | | ( | | | | | | | | | | | | ( | | | | ( |
Other comprehensive income / (loss) | | | | | | | | | | | | ( | | | | | | ( | | | ( | | | | ( |
Total comprehensive income / (loss) for the period | | | — | | | — | | | ( |
| | ( | | | — | | | ( | | | ( |
|
| | ( |
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 year ended June 30, 2024 |
| $ | |
| $ | |
| $ | ( |
| $ | | | $ | | | $ | ( |
| $ | |
|
| $ | |
Please refer to note 8 for more information on the share capital.
The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.
11
ARGENX SE
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
1. General information about the company
argenx SE (the Company) 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 Rotterdam, the Netherlands, and its registered office is at Laarderhoogteweg 25, 1101 EB Amsterdam, the Netherlands.
argenx SE is a publicly traded company with ordinary shares listed on Euronext Brussels under the symbol “ARGX” since July 2014 and with American Depositary Shares listed on Nasdaq under the symbol “ARGX” since May 2017.
2. Basis of preparation
The unaudited condensed consolidated interim financial statements for the six months ended June 30, 2024 have been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ as issued by the IASB and as adopted by the European Union. The unaudited condensed consolidated interim financial statements should be read in conjunction with the annual financial statements for the year ended December 31, 2023.
All amounts herein are presented in thousands of $, unless otherwise indicated, rounded to the nearest $ ‘000.
The unaudited condensed consolidated financial statements have been approved for issue by the Company’s Board of Directors (the “Board”) on July 23, 2024.
3. Material accounting policy information
There were no significant changes in the material accounting policies, critical accounting judgements and key sources of estimation uncertainty applied by us in these unaudited condensed consolidated interim financial statements compared to those used in the annual consolidated financial statements as of December 31, 2023.
4. Other non-current assets
| | At June 30, | | At December 31, | ||
(in thousands of $) |
| 2024 |
| 2023 | ||
Non-current restricted cash |
| $ | |
| $ | |
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 |
| $ | |
| $ | |
Please also refer to note 15 for more information on the financial instruments.
5. Inventories
| | At June 30, | | At December 31, | ||
(in thousands of $) |
| 2024 |
| 2023 | ||
Raw materials and consumables | | $ | |
| $ | |
Inventories in process | | | | | | |
Finished goods | | | | | | |
Total inventories |
| $ | |
| $ | |
The cost of inventories, which is recognized under “Cost of sales” on the unaudited condensed consolidated statements of profit or loss, amounted to $
On June 30, 2024, pre-launch inventory awaiting facility approval amounted to $
12
6. Trade and other receivables
Trade and other receivables are composed of receivables which are detailed below:
| | At June 30, | | At December 31, | ||
(in thousands of $) |
| 2024 |
| 2023 | ||
Trade receivable | | $ | | | $ | |
Interest receivable | | | | | | |
Tax receivables | | | | | | |
Other receivables | | | | | | |
Total trade and other receivables |
| $ | |
| $ | |
The carrying amounts of trade and other receivables approximate their respective fair values. On June 30, 2024 and December 31, 2023, the Company did not have any provision for expected credit losses.
On June 30, 2024, Other receivables include $
7. Cash and cash equivalents
| | At June 30, | | At December 31, | ||
(in thousands of $) |
| 2024 |
| 2023 | ||
Money market funds |
| $ | |
| $ | |
Term accounts | | | | | | |
Cash and bank balances |
| | |
| | |
Total cash and cash equivalents |
| $ | |
| $ | |
On June 30, 2024, Cash and cash equivalents amounted to $
Please also refer to note 15 for more information on the financial instruments.
8. Shareholders’ capital
On June 30, 2024, the Company’s share capital was represented by
Number of shares outstanding on December 31, 2023 |
| |
Exercise of stock options | | |
Vesting of RSUs | | |
Number of shares outstanding on June 30, 2024 |
| |
9. Share based payments
The Company has an equity incentive plan for the employees, key consultants, board members, senior managers and key outside advisors (“key persons”) of the Company and its subsidiaries. In accordance with the term of the plan, as approved by shareholders, employees may be granted stock options and/or restricted stock units.
13
9.1 Stock options
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
The stock options granted vest, in principle, as follows:
| ● | of the total stock options granted on the first anniversary of the granting of the stock options; and |
| ● | of the total grant on the first day of each month following the first anniversary of the date of grant 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 4th year following the date of grant of those stock options, and in any case no later than the expiration date of the option.
Below is an overview of the parameters used in relation to the new grant during the six months ended June 30, 2024:
Stock options granted in |
| April 2024 |
| June 2024 (1) | | ||
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 June 2024, the Company granted a total of |
| (2) | 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 unaudited condensed consolidated statement of profit or loss totaled $
9.2 Restricted Stock Units (RSUs)
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
The total share-based payment expense related to RSUs recognized in the unaudited condensed consolidated interim statements of profit or loss totaled $
14
10. Trade and other payables
| | At June 30, | | At December 31, | ||
(in thousands of $) |
| 2024 |
| 2023 | ||
Trade payables |
| $ | |
| $ | |
Gross-to-net accruals | | | | | | |
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 clinical and manufacturing activities and include accrued expenses related to these activities.
Short-term employee benefits include payables and accruals for compensation and bonuses to be paid to the employees of the Company.
The following table summerizes the movement in the Gross-to-net accruals for the period ended June 30, 2024:
(in thousands of $) | | Rebates and chargebacks | | Distribution fees, product returns and other | | Total Gross-to-net accruals | |||
Balance at December 31, 2022 | | $ | | | $ | | | $ | |
Estimate related to the sales made in the current year | | | | | | | | | |
Adjustment for prior year sales | | | ( | | | ( | | | ( |
(Credits or payments) | | | ( | | | ( | | | ( |
Balance at December 31, 2023 | | $ | | | $ | | | $ | |
Estimate related to the sales made in the current period | | | | | | | | | |
Adjustment for prior year sales | | | ( | | | ( | | | ( |
(Credits or payments) | | | ( | | | ( | | | ( |
Balance at June 30, 2024 | | $ | | | $ | | | $ | |
11. Segment reporting
The Company manages its activities and operates as
The following table summarizes the product net sales by region of sales:
| | Six Months Ended | ||||
| | June 30, | ||||
(in thousands of $) |
| 2024 |
| 2023 | ||
North America | | $ | | | $ | |
Japan | | | | | | |
EMEA | | | | | | |
China | | | | | | — |
Total product net sales |
| $ | |
| $ | |
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We sell our products through a limited number of distributors and wholesalers.
12. Research and development expenses
| | Six Months Ended | ||||
| | June 30, | ||||
(in thousands of $) |
| 2024 |
| 2023 | ||
Personnel expenses |
| $ | |
| $ | |
External research and development expenses |
| | |
| | |
Materials and consumables |
| | |
| | |
Depreciation and amortization |
| | |
| | |
IT expenses | | | | | | |
Other expenses |
| | |
| | |
Total Research and development expenses |
| $ | |
| $ | |
13. Selling, general and administrative expenses
| | Six Months Ended | ||||
| | June 30, | ||||
(in thousands of $) |
| 2024 |
| 2023 | ||
Personnel expenses |
| $ | |
| $ | |
Marketing services |
| | | | | |
Professional fees | | | | | | |
Supervisory board |
| | |
| | |
Depreciation and amortization | | | | | | |
IT expenses | | | | | | |
Other expenses |
| | |
| | |
Total Selling, general and administrative expenses |
| $ | |
| $ | |
14. Income taxes
The Company recorded an income tax benefit of $
16
15. Financial instruments and financial risk management
The Company carried the following assets at fair value on June 30, 2024 and December 31, 2023, respectively:
| | At June 30, 2024 | |||||||
(in thousands of $) |
| Level 1 |
| Level 2 |
| Level 3 | |||
Non-current financial assets |
| $ | |
| $ | — |
| $ | |
Cash and cash equivalents | | | | | | — | | | — |
Assets carried at fair value |
| $ | |
| $ | — |
| $ | |
| | At 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 |
| $ | |
| $ | — |
| $ | |
Non-current financial assets – Level 3
The Company has a profit share in AgomAb Therapeutics NV. Since AgomAb Therapeutics NV is a private company, the valuation of the profit is based on level 3 assumptions.
In October 2023, AgomAb Therapeutics NV secured $
Non-current financial assets – Level 1
As part of the license agreement for the development and commercialization for efgartigimod in Greater China, the Company obtained, amongst others,
16. Related party transaction
The Company has a joint venture agreement with the University of Colorado Anschutz Medical Campus and UCHealth as a separate legal entity, OncoVerity, Inc. The Company contributed $
During the six months ended June 30, 2024 a total of
17. Contractual obligations and commitments
At balance sheet date, there were
In February 2019, and as amended in September 2020, the Company entered into a global collaboration and license agreement with Halozyme Therapeutics, Inc. Under the terms of the agreement as of June 30, 2024, the Company will pay up to $
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maximum amount that would be paid if all milestones would be achieved but excludes variable royalty payments based on unit sales.
The Company’s manufacturing commitments with Lonza, its drug substance manufacturing contractor, relate to the ongoing execution of the biologic license application (BLA) services for efgartigimod and its manufacturing activities related to the commercialization or potential future commercialization. In December 2018, the Company signed its first commercial supply agreement with Lonza related to the reservation of commercial drug substance supply capacity for efgartigimod. In the aggregate, as of June 30, 2024, the Company has outstanding commitments for efgartigimod under the first commercial supply agreement of $
As of June 30, 2024, the Company had a line of credit totalling to $
18. Events after the balance sheet date
No events have occurred after the balance sheet date that could have a material impact on the unaudited condensed consolidated financial statements.
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