6-K
Argenx SE (ARGX)
| UNITED STATES<br><br>SECURITIES AND EXCHANGE COMMISSION<br><br>WASHINGTON, D.C. 20549 | |
|---|---|
| FORM 6-K | |
| REPORT OF FOREIGN PRIVATE ISSUER<br><br>PURSUANT TO RULE 13a-16 OR 15d-16<br><br>UNDER THE SECURITIES EXCHANGE ACT OF 1934<br><br><br><br>For the Month of February 2026<br><br><br><br>Commission File Number: 001-38097 | |
| ARGENX SE | |
| (Translation of registrant’s name into English) | |
| Laarderhoogtweg 25<br>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.<br><br><br><br>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): ☐ | |
| EXPLANATORY NOTE | |
| --- | |
| On February 26, 2026, argenx SE (the “Company’’) issued a press release, an investor presentation and its full year 2025 unaudited financial results, copies of which are attached hereto as Exhibits 99.1, Exhibit 99.2 and Exhibit 99.3, respectively, and are incorporated by reference herein. | |
| The information contained in this Current Report on Form 6-K, including Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3, shall be deemed to be incorporated by reference into the Company’s Registration Statements on Form S-8 (File Nos. 333-292200, 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333-274721), and to be part thereof from the date on which this Current Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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 | Press Release dated February 26, 2026 |
| 99.2 | Investor Presentation dated February 26, 2026 |
| 99.3 | UnauditedFull Yeara10unauditedfullyear2025fi.htm2025Financial Results |
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: February 26, 2026 | By: | /s/ Hemamalini (Malini) Moorthy |
| Name: Hemamalini (Malini) Moorthy | ||
| Title: General Counsel |
Document
argenx Reports Full Year 2025 Financial Results and Provides Fourth Quarter Business Update
$1.3 billion in fourth-quarter and $4.2 billion in full-year global product net sales, representing 90% year‑over‑year growth
Delivered $1.1 billion in operating income in 2025, marking first year of operating profitability
VYVGART MG label expansion supported by positive ADAPT SERON and OCULUS results; PDUFA target action date of May 10, 2026 for anti‑AChR antibody‑negative (“seronegative”) gMG
Management to host conference call today at 2:30 PM CET (8:30 AM ET)
February 26, 2026 7:00 AM CET
Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today reported financial results for the full year 2025 and provided a fourth quarter business update.
In a separate press release issued today, argenx announced positive results from the Phase 3 ADAPT OCULUS study evaluating VYVGART SC pre-filled syringe (PFS) for the treatment of adult patients living with ocular myasthenia gravis (oMG). The primary endpoint was met (p=0.012), demonstrating statistically significant improvement from baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 in treated patients compared to placebo. No new safety concerns were identified.
“argenx delivered another standout year of execution in 2025,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We reached 19,000 patients globally with VYVGART, expanded our impact across gMG and CIDP through the successful launch of the pre‑filled syringe, and made substantial progress across our development programs, advancing the pipeline towards key milestones.”
“2026 is another year of expansion for argenx,” continued Mr. Van Hauwermeiren. “Positive data in ocular MG and the priority review of our seronegative gMG filing bring us closer to reaching even more MG patients with the broadest possible label, reinforcing our leadership in shaping the MG market. Momentum across our FcRn portfolio, including expansion into rheumatology, together with continued progress across our broader pipeline with empasiprubart, adimanebart and new first-in-class candidates from our Immunology Innovation Program, supports our next horizon of growth toward Vision 2030 and beyond.”
Strategic Priorities to Advance Vision 2030
argenx continues to advance its ‘Vision 2030’ anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications across approved medicines, and progress five pipeline candidates into Phase 3 development by 2030.
Impact more patients globally with VYVGART
VYVGART® (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-and-only IgG Fc-antibody fragment that targets the neonatal Fc receptor (FcRn). It is approved in three indications, including generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. argenx is driving broad adoption as the leading precision biologic in MG and CIDP while advancing multiple label expansions.
•Generated $1.3 billion in global product net sales in the fourth quarter and $4.2 billion for the full year 2025, representing an increase of 90% or approximately $2 billion in year-over-year growth
•Prescription Drug User Fee Act (PDUFA) target action date for anti-acetylcholine receptor antibody negative (AChR-Ab-) gMG (MuSK+, LRP4+ and triple seronegative) is May 10, 2026
•Positive topline results from ADAPT OCULUS support planned sBLA submission to expand VYVGART label into oMG
•Topline results expected for primary ITP (ADVANCE-NEXT) in fourth quarter of 2026
•Registrational studies are ongoing in two rheumatology indications
◦Topline results from ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) expected in third quarter of 2026
◦Topline results from UNITY study (Sjogren’s disease) expected in second half of 2027
•Registrational study in Graves’ disease (GD) expected to initiate in 2026, expanding development into thyroid-driven autoimmunity
Shape the long-term future of FcRn medicines
argenx is focused on shaping the long-term future of FcRn medicines by advancing new pipeline candidates, innovative delivery modalities and combination approaches to set new standards for patients.
•VYVGART SC autoinjector expected to launch in 2027
•ADAPT-Forward combination study ongoing to evaluate empasiprubart as an add on therapy to efgartigimod
•Progressing two next‑generation FcRn candidates in 2026: ARGX‑213 is expected to enter patient studies and ARGX‑124 expected to complete Phase 1
Deliver next wave of immunology innovation
By the end of 2026, the argenx pipeline will include four Phase 3 molecules and a total of 10 molecules in clinical development. Empasiprubart (anti-C2) is in Phase 3 for MMN and CIDP and adimanebart (MuSK agonist) will enter Phase 3 for congenital myasthenic syndromes (CMS). ARGX-121 (anti-IgA) and ARGX-109 (anti-IL-6) are both entering patient studies this year. Three additional molecules from the IIP are expected to enter Phase 1 in 2026, supporting argenx’s goal of launching, on average, one new pipeline candidate each year.
Empasiprubart
•Topline results from EMPASSION study (MMN) expected in fourth quarter of 2026
•Topline results from EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027
•Decision for Phase 2 VARVARA study (DGF) expected mid-year 2026 to complete 52-week efficacy analysis
Adimanebart
•CMS registrational study on track to start in third quarter of 2026
•Topline Phase 2a data from amyotrophic lateral sclerosis (ALS) study does not support continued development
Earlier-stage Programs
•Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) expected to start in 2026
•Three new first-in-class molecules are on track to enter Phase 1 in 2026, including ARGX‑118 (Galectin‑10 inhibitor), ARGX‑125 (bispecific antibody), and TSP‑101, the Fn14‑targeting program from the Tensegrity research collaboration
FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
| Three Months Ended | Twelve Months Ended | |||||||
|---|---|---|---|---|---|---|---|---|
| December 31 | December 31 | |||||||
| (in thousands of $ except for per share data) | 2025 | 2024 | 2025 | 2024 | ||||
| Product net sales | $ | 1,285,711 | $ | 736,968 | $ | 4,151,316 | $ | 2,185,883 |
| Other operating income* | 36,444 | 24,252 | 96,734 | 66,156 | ||||
| Total operating income | 1,322,155 | 761,220 | 4,248,050 | 2,252,039 | ||||
| Cost of sales | $ | (149,687) | $ | (72,656) | $ | (450,665) | $ | (227,289) |
| Research and development expenses | (371,714) | (297,228) | (1,364,132) | (983,423) | ||||
| Selling, general and administrative expenses | (429,616) | (285,945) | (1,367,057) | (1,055,337) | ||||
| Loss from investment in a joint venture | (3,527) | (2,350) | (12,390) | (7,644) | ||||
| Total operating expenses | (954,544) | (658,179) | (3,194,244) | (2,273,693) | ||||
| Operating profit/(loss) | $ | 367,611 | $ | 103,041 | $ | 1,053,806 | $ | (21,654) |
| Financial income | $ | 44,874 | $ | 39,095 | $ | 163,091 | $ | 157,509 |
| Financial expense | (828) | (704) | (4,082) | (2,464) | ||||
| Exchange (losses)/gains | (8,363) | (54,923) | 65,792 | (48,211) | ||||
| Profit for the period before taxes | $ | 403,294 | $ | 86,509 | $ | 1,278,607 | $ | 85,180 |
| Income tax benefit | $ | 129,656 | $ | 687,652 | $ | 13,428 | $ | 747,860 |
| Profit for the period | $ | 532,950 | $ | 774,161 | $ | 1,292,035 | $ | 833,040 |
| Profit for the period attributable to: | ||||||||
| Owners of the parent | $ | 532,950 | $ | 774,161 | $ | 1,292,035 | $ | 833,040 |
| Weighted average number of shares outstanding used for basic profit per share | 61,732,177 | 60,517,968 | 61,294,149 | 59,855,585 | ||||
| Basic profit per share (in $) | $ | 8.63 | $ | 12.79 | $ | 21.08 | $ | 13.92 |
| Weighted average number of shares outstanding used for diluted profit per share | 66,428,415 | 65,661,428 | 66,029,215 | 65,177,815 | ||||
| Diluted profit per share (in $) | $ | 8.02 | $ | 11.79 | $ | 19.57 | $ | 12.78 |
*Comparative figures have been presented to be consistent with the one adopted in the current period with respect to the combination of collaboration revenue and other operating income.
DETAILS OF THE FINANCIAL RESULTS
Total operating income for the three and twelve months ended December 31, 2025 was $1.3 billion and $4.2 billion, respectively, compared to $0.8 billion and $2.3 billion, respectively, for the same periods in 2024, and mainly consisted of:
•Product net sales of VYVGART for the three and twelve months ended December 31, 2025 were $1.3 billion and $4.2 billion, respectively, compared to $0.7 billion and $2.2 billion, respectively, for the same periods in 2024.
•Other operating income for the three and twelve months ended December 31, 2025 was $36 million and $97 million, respectively, compared to $24 million, and $66 million, respectively, for the same periods in 2024. The other operating income primarily relates to research and development tax incentives and payroll tax rebates.
Total operating expenses for the three and twelve months ended December 31, 2025 were $1.0 billion and $3.2 billion, respectively, compared to $0.7 billion and $2.3 billion, respectively, for the same periods in 2024, and mainly consisted of:
•Cost of sales for the three and twelve months ended December 31, 2025 was $150 million and $451 million, respectively, compared to $73 million and $227 million, respectively, for the same periods in 2024. The cost of sales was recognized with respect to the sale of VYVGART.
•Research and development expenses for the three and twelve months ended December 31, 2025 were $0.4 billion and $1.4 billion, respectively, compared to $0.3 billion and $1.0 billion, respectively, for the same periods in 2024. The expenses mainly related to:
◦Advancing efgartigimod across multiple severe autoimmune indications;
◦Progressing empasiprubart into multiple indications;
◦Executing studies for adimanebart in rare neuromuscular diseases; and
◦Early-stage discovery and preclinical programs to sustain long-term pipeline growth.
•Selling, general and administrative expenses for the three and twelve months ended December 31, 2025 were $0.4 billion and $1.4 billion, respectively, compared to $0.3 billion and $1.1 billion, respectively, for the same periods in 2024. The selling, general and administrative expenses mainly related to professional and marketing fees linked to global commercialization of the VYVGART franchise, and personnel expenses.
Financial income for the three and twelve months ended December 31, 2025 was $45 million and $163 million, respectively, compared to $39 million and $158 million, respectively, for the same periods in 2024.
Income tax benefit
| Three Months Ended | Twelve Months Ended | ||||||
|---|---|---|---|---|---|---|---|
| December 31 | December 31 | ||||||
| (in millions of $) | 2025 | 2024 | 2025 | 2024 | |||
| Current tax expense | $ | (216) | (25) | (338) | (54) | ||
| Deferred tax benefit | 346 | 713 | 351 | 802 | |||
| Income tax benefit | $ | 130 | 688 | 13 | 748 |
Profit for the three and twelve month periods ended December 31, 2025 was $533 million and $1.3 billion, respectively, compared to $774 million and $833 million, respectively, for the same periods in 2024. On a per weighted average share basis, the basic profit per share was $21.08 for the year ended December 31, 2025, compared to $13.92 for the year ended December 31, 2024.
EXPECTED 2026 FINANCIAL CALENDAR
•March 19, 2026: Publication of the 2025 Annual Report
•May 6, 2026: Annual General Meeting of Shareholders in Amsterdam, the Netherlands
•May 7, 2026: First Quarter 2026 Financial Results and Business Update
•July 23, 2026: Half Year and Second Quarter 2026 Financial Results and Business Update
•October 22, 2026: Third Quarter 2026 Financial Results and Business Update
CONFERENCE CALL DETAILS
The full year 2025 financial results and 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.
Belgium 32 800 50 201 France 33 800 943355 Netherlands 31 20 795 1090 United Kingdom 44 800 358 0970 United States 1 888 415 4250 Japan 81 3 4578 9081 Switzerland 41 43 210 11 32
About VYVGART
VYVGART® (efgartigimod alfa fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and for primary immune thrombocytopenia (ITP) in Japan. VYVGART SC is a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. It is marketed as VYVGART® Hytrulo in the U.S., VYVGART SC in Europe, VYVDURA® in Japan, and may be marketed under different proprietary names following approval in other regions.
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 and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube.
Media: Ben Petok bpetok@argenx.com
Investors: Alexandra Roy aroy@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,” “commit,” “continue,” “expand,” “expect,” and “progress,” and include statements argenx makes concerning its belief that 2026 is a year of expansion for the Company; its goal to expand the use of VYVGART to the broadest possible label to reach even more MG patients; its growth due to its momentum across its FcRn portfolio, together with continued progress across its broader pipeline with empasiprubart, adimanebart and new first-in-class candidates from its Immunology Innovation Program; its continued advancement of its ‘Vision 2030’ anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications across approved medicines, and progress five pipeline candidates into Phase 3 development by 2030; the filing of the sBLA for oMG; the expected timing of topline results expected for primary ITP (ADVANCE-NEXT) in fourth quarter of 2026; the expected timing of its ongoing registrational studies in two rheumatology indications: (1) topline results from ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) expected in third quarter of 2026 and (2) topline results from UNITY study (Sjogren’s disease) expected in second half of 2027; the expected timing of the registrational study in Graves’ disease (GD) expected to initiate in 2026; its advancement of new pipeline candidates, innovative delivery modalities and combination approaches to set new standards for patients, including the expected timing of: (1) VYVGART SC autoinjector expected to launch in 2027; and (2) the progression of two next‑generation FcRn candidates in 2026: ARGX‑213 expected to enter patient studies and ARGX‑124 expected to complete Phase 1; its expectation that by the end of 2026, the argenx pipeline will include four Phase 3 molecules and a total of 10 molecules in clinical development, including: (1) Empasiprubart (anti-C2) in Phase 3 for MMN and CIDP; (2) adimanebart (MuSK agonist) entering Phase 3 for congenital myasthenic syndromes (CMS); (3) ARGX-121 (anti-IgA) and ARGX-109 (anti-IL-6) both entering patient studies this year; and (4) three additional molecules from the IIP entering Phase 1 in 2026, supporting argenx’s goal of launching, on average, one new pipeline candidate each year; the expected timing of its empasiprubart topline results from (1) EMPASSION study (MMN) in fourth quarter of 2026 and (2) EMVIGORATE and EMNERGIZE studies (CIDP) in second half of 2027; the expected timing of the decision for empasiprubart Phase 2 VARVARA study (DGF) at mid-year 2026 to complete 52-week efficacy analysis; the expected timing of the adimanebart CMS registrational study to start in third quarter of 2026; the expected timing of its clinical studies for its earlier-stage programs, including (1) Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) to start in 2026 and (2) three new first-in class molecules to enter Phase 1 in 2026, including ARGX‑118 (Galectin‑10 inhibitor), ARGX‑125 (bispecific antibody), and TSP‑101, the Fn14‑targeting program from the Tensegrity research collaboration; its expected 2026 financial calendar,; its commitment to improve the lives of people suffering from severe autoimmune diseases; and its aim to translate 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 but not limited to, 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; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; 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.
Document
ARGENX SE
UNAUDITED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| As of December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (in thousands of $) | 2025 | 2024 | 2023 | |||||||||||
| Assets | ||||||||||||||
| Non‑current assets | ||||||||||||||
| Property, plant and equipment | $ | 48,247 | $ | 43,517 | $ | 22,675 | ||||||||
| Intangible assets | 272,103 | 181,445 | 125,228 | |||||||||||
| Deferred tax assets | 1,295,853 | 924,299 | 97,211 | |||||||||||
| Research and development incentive receivables | 86,212 | 94,854 | 76,706 | |||||||||||
| Investment in a joint venture | 3,378 | 9,268 | 9,912 | |||||||||||
| Prepaid expenses | 25,811 | 23,643 | 47,327 | |||||||||||
| Other non-current assets | 51,990 | 42,393 | 39,662 | |||||||||||
| Total non‑current assets | $ | 1,783,594 | $ | 1,319,419 | $ | 418,721 | ||||||||
| Current assets | ||||||||||||||
| Inventories | $ | 473,530 | $ | 407,233 | $ | 310,550 | ||||||||
| Prepaid expenses | 328,476 | 187,948 | 134,072 | |||||||||||
| Trade and other receivables | 1,646,692 | 904,471 | 496,687 | |||||||||||
| Research and development incentive receivables | 10,367 | 4,625 | 2,584 | |||||||||||
| Financial assets | 948,750 | 1,878,890 | 1,131,000 | |||||||||||
| Cash and cash equivalents | 3,491,289 | 1,499,936 | 2,048,844 | |||||||||||
| Total current assets | $ | 6,899,104 | $ | 4,883,103 | $ | 4,123,737 | ||||||||
| Total assets | $ | 8,682,698 | $ | 6,202,522 | $ | 4,542,458 | As of December 31, | |||||||
| --- | --- | --- | --- | --- | --- | --- | ||||||||
| (in thousands of $) | 2025 | 2024 | 2023 | |||||||||||
| Equity and liabilities | ||||||||||||||
| Equity | ||||||||||||||
| Equity attributable to owners of the parent | ||||||||||||||
| Share capital | $ | 7,354 | $ | 7,227 | $ | 7,058 | ||||||||
| Share premium | 6,186,554 | 5,948,916 | 5,651,497 | |||||||||||
| Translation differences | 138,570 | 126,832 | 131,543 | |||||||||||
| Accumulated losses | (279,769) | (1,571,804) | (2,404,844) | |||||||||||
| Other reserves | 1,270,383 | 987,112 | 712,253 | |||||||||||
| Total equity | $ | 7,323,092 | $ | 5,498,283 | $ | 4,097,507 | ||||||||
| Non-current liabilities | ||||||||||||||
| Provisions for employee benefits | $ | 3,093 | $ | 1,803 | $ | 1,449 | ||||||||
| Lease liabilities | 36,327 | 32,520 | 15,354 | |||||||||||
| Deferred tax liabilities | — | — | 5,155 | |||||||||||
| Total non-current liabilities | $ | 39,420 | $ | 34,323 | $ | 21,958 | ||||||||
| Current liabilities | ||||||||||||||
| Lease liabilities | $ | 10,833 | $ | 6,533 | $ | 4,646 | ||||||||
| Trade and other payables | 1,267,144 | 649,993 | 414,013 | |||||||||||
| Tax liabilities | 42,209 | 13,390 | 4,334 | |||||||||||
| Total current liabilities | $ | 1,320,186 | $ | 669,916 | $ | 422,993 | ||||||||
| Total liabilities | $ | 1,359,606 | $ | 704,239 | $ | 444,951 | ||||||||
| Total equity and liabilities | $ | 8,682,698 | $ | 6,202,522 | $ | 4,542,458 |
ARGENX SE
UNAUDITED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
| (in thousands of except for shares and EPS) | 2024 | 2023 | |||
| Product net sales | 4,151,316 | $ | 2,185,883 | $ | 1,190,783 |
| Other operating income1) | 96,734 | 66,156 | 77,811 | ||
| Total operating income | 4,248,050 | 2,252,039 | 1,268,594 | ||
| Cost of sales | (450,665) | (227,289) | (117,835) | ||
| Research and development expenses | (1,364,132) | (983,423) | (859,492) | ||
| Selling, general and administrative expenses | (1,367,057) | (1,055,337) | (711,905) | ||
| Loss from investment in a joint venture | (12,390) | (7,644) | (4,411) | ||
| Total operating expenses | (3,194,244) | (2,273,693) | (1,693,643) | ||
| Operating profit/(loss) | 1,053,806 | $ | (21,654) | $ | (425,049) |
| Financial income | 163,091 | 157,509 | 107,386 | ||
| Financial expense | (4,082) | (2,464) | (906) | ||
| Exchange gains/(losses) | 65,792 | (48,211) | 14,073 | ||
| Profit/(Loss) for the year before taxes | 1,278,607 | $ | 85,180 | $ | (304,496) |
| Income tax benefit | 13,428 | $ | 747,860 | $ | 9,443 |
| Profit/(Loss) for the year | 1,292,035 | $ | 833,040 | $ | (295,053) |
| Profit/(Loss) for the year attributable to: | |||||
| Owners of the parent | 1,292,035 | 833,040 | (295,053) | ||
| Weighted average number of shares used for basic profit/(loss) per share | 61,295,149 | 59,855,585 | 57,169,253 | ||
| Basic profit/(loss) per share (in ) | 21.08 | 13.92 | (5.16) | ||
| Weighted average number of shares used for diluted profit/(loss) per share | 66,029,215 | 65,177,815 | 57,169,253 | ||
| Diluted profit/(loss) per share (in ) | 19.57 | 12.78 | (5.16) |
All values are in US Dollars.
1)Comparative figures have been aligned with the presentation adopted in the current period, reflecting the combination of collaboration revenue and other operating income.
ARGENX SE
UNAUDITED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME OR LOSS
| Year Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| (in thousands of $) | 2025 | 2024 | 2023 | |||
| Profit/(Loss) for the year | $ | 1,292,035 | $ | 833,040 | $ | (295,053) |
| Items that may be reclassified subsequently to profit or loss, net of tax | ||||||
| Currency translation differences, arisen from translating foreign activities | 11,738 | (4,711) | 2,263 | |||
| 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 | (4,858) | (648) | (1,915) | |||
| Other comprehensive profit/(loss), net of income tax | $ | 6,880 | $ | (5,359) | $ | 348 |
| Total comprehensive profit/(loss) attributable to: | ||||||
| Owners of the parent | $ | 1,298,915 | $ | 827,681 | $ | (294,705) |
ARGENX SE
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Year Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| (in thousands of $) | 2025 | 20241) | 20231) | |||
| Operating profit/(loss) | $ | 1,053,806 | $ | (21,654) | $ | (425,049) |
| Adjustments for non-cash items | ||||||
| Amortization of intangible assets | 14,858 | 10,282 | 105,674 | |||
| Depreciation of property, plant and equipment | 13,244 | 7,245 | 5,633 | |||
| Provisions for employee benefits | 1,151 | 432 | 573 | |||
| Expense recognized in respect of share-based payments | 248,079 | 235,179 | 232,974 | |||
| Fair value gains on financial assets at fair value through profit or loss | (11,581) | (3,834) | — | |||
| Loss from investment in a joint venture | 12,390 | 7,644 | 4,411 | |||
| Other non-cash expenses/(benefit) | 31,628 | (277) | 2,074 | |||
| $ | 1,363,575 | $ | 235,017 | $ | (73,710) | |
| Movements in current assets/liabilities | ||||||
| (Increase)/decrease in trade and other receivables | (802,327) | (423,112) | (185,694) | |||
| (Increase)/decrease in inventories | (98,952) | (95,996) | (83,030) | |||
| (Increase)/decrease in current prepaid expenses | (139,992) | (54,113) | (58,081) | |||
| (Increase)/decrease in other current assets | (5,742) | (2,041) | (943) | |||
| Increase/(decrease) in trade and other payables | 612,328 | 246,336 | 95,600 | |||
| Movements in non-current assets/liabilities | ||||||
| (Increase)/decrease in other non‑current assets | 14,224 | (19,930) | (29,416) | |||
| (Increase)/decrease in non-current prepaid expense | (2,167) | 23,683 | (47,327) | |||
| Net cash flows from/(used) in operating activities, before interest and taxes | $ | 940,947 | $ | (90,156) | $ | (382,601) |
| Interest paid | (900) | (392) | (211) | |||
| Income taxes (paid)/received | (254,855) | 7,801 | (37,515) | |||
| Net cash flows from/(used) in operating activities | $ | 685,192 | $ | (82,747) | $ | (420,327) |
| Purchase of intangible assets | (105,515) | (66,500) | (43,000) | |||
| Purchase of property, plant and equipment | (6,165) | (1,801) | (812) | |||
| Purchase of current financial assets | (1,448,930) | (2,183,542) | (1,271,730) | |||
| Sale of current financial assets | 2,388,445 | 1,429,600 | 1,543,999 | |||
| Interest received | 162,670 | 111,649 | 92,753 | |||
| Investment in a joint venture | (6,500) | (7,000) | (13,000) | |||
| Net cash flows from/(used in) investing activities | $ | 984,005 | $ | (717,594) | $ | 308,210 |
| Principal elements of lease payments | (4,107) | (7,638) | (3,801) | |||
| Proceeds from issue of new shares, gross amount | — | — | 1,196,731 | |||
| Issue costs paid | — | — | (821) | |||
| Exchange (losses)/gains from currency conversion on proceeds from issue of new shares | — | — | (1,507) | |||
| Payment of employee withholding taxes relating to restricted stock unit awards | (41,258) | (21,868) | (12,138) | |||
| Proceeds from exercise of stock options | 278,375 | 309,265 | 158,263 | |||
| Net cash flows from financing activities | $ | 233,010 | $ | 279,759 | $ | 1,336,727 |
| Increase/(decrease) in cash and cash equivalents | $ | 1,902,207 | $ | (520,582) | $ | 1,224,610 |
| Cash and cash equivalents at the beginning of the year | $ | 1,499,936 | $ | 2,048,844 | $ | 800,740 |
| Exchange gains/(losses) on cash and cash equivalents | $ | 89,146 | $ | (28,326) | $ | 23,494 |
| Cash and cash equivalents at the end of the year | $ | 3,491,289 | $ | 1,499,936 | $ | 2,048,844 |
1) Comparative figures have been aligned to the presentation adopted in the current year.
ARGENX SE
UNAUDITED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
| 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 | $ | 6,640 | $ | 4,309,880 | $ | (2,109,791) | $ | 129,280 | $ | 535,247 | $ | (57,557) | $ | 2,813,699 | $ | 2,813,699 |
| Loss for the year | (295,053) | (295,053) | (295,053) | |||||||||||||
| Other comprehensive income/(loss) | 2,263 | (1,915) | 348 | 348 | ||||||||||||
| Total comprehensive income/(loss) for the year | — | — | (295,053) | 2,263 | — | (1,915) | (294,705) | (294,705) | ||||||||
| Income tax benefit from excess tax deductions related to share-based payments | 2,310 | 2,310 | 2,310 | |||||||||||||
| Share-based payment | 234,168 | 234,168 | 234,168 | |||||||||||||
| Issue of share capital | 288 | 1,196,444 | 1,196,732 | 1,196,732 | ||||||||||||
| Transaction costs for equity issue | (821) | (821) | (821) | |||||||||||||
| Exercise of stock options | 130 | 158,133 | 158,263 | 158,263 | ||||||||||||
| Ordinary shares withheld for payment of employees’ withholding tax liability | (12,139) | (12,139) | (12,139) | |||||||||||||
| Balance on December 31, 2023 | $ | 7,058 | $ | 5,651,497 | $ | (2,404,844) | $ | 131,543 | $ | 771,725 | $ | (59,472) | $ | 4,097,507 | $ | 4,097,507 |
| Profit for the year | 833,040 | 833,040 | 833,040 | |||||||||||||
| Other comprehensive loss | (4,711) | (648) | (5,359) | (5,359) | ||||||||||||
| Total comprehensive income/(loss) for the year | — | — | 833,040 | (4,711) | — | (648) | 827,681 | 827,681 | ||||||||
| Income tax benefit from excess tax deductions related to share-based payments | 39,650 | 39,650 | 39,650 | |||||||||||||
| Share-based payment | 235,856 | 235,856 | 235,856 | |||||||||||||
| Exercise of stock options | 169 | 319,288 | 319,457 | 319,457 | ||||||||||||
| Ordinary shares withheld for payment of employees’ withholding tax liability | (21,869) | (21,869) | (21,869) | |||||||||||||
| Balance on December 31, 2024 | $ | 7,227 | $ | 5,948,916 | $ | (1,571,804) | $ | 126,832 | $ | 1,047,231 | $ | (60,119) | $ | 5,498,283 | $ | 5,498,283 |
| Profit for the year | 1,292,035 | 1,292,035 | 1,292,035 | |||||||||||||
| Other comprehensive income/(loss) | 11,738 | (4,858) | 6,880 | 6,880 | ||||||||||||
| Total comprehensive income/(loss) for the year | — | — | 1,292,035 | 11,738 | — | (4,858) | 1,298,915 | 1,298,915 | ||||||||
| Income tax benefit from excess tax deductions related to share-based payments | 38,780 | 38,780 | 38,780 | |||||||||||||
| Share-based payment | 249,349 | 249,349 | 249,349 | |||||||||||||
| Exercise of stock options | 127 | 278,896 | 279,023 | 279,023 | ||||||||||||
| Ordinary shares withheld for payment of employees’ withholding tax liability | (41,258) | (41,258) | (41,258) | |||||||||||||
| Balance on December 31, 2025 | $ | 7,354 | $ | 6,186,554 | $ | (279,769) | $ | 138,570 | $ | 1,335,360 | $ | (64,977) | $ | 7,323,092 | $ | 7,323,092 |
argxq4slides_final
Leading a new era of innovation in immunology 1 4 Q 2 0 2 5 F I N A N C I A L R E S U L T S C A L L F E B R U A R Y 2 6 , 2 0 2 6
Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company or any director, employee, agent, or adviser of the company. This presentation does not purport to be all-inclusive or to contain all of the information you may desire. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the company’s own internal estimates and research. While argenx believes these third-party studies, publications, surveys and other data to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of argenx’s internal estimates or research, and no reliance should be made on any information or statements made in this presentation relating to or based on such internal estimates and research. Certain statements contained in this presentation, other than present and historical facts and conditions independently verif iable at the date hereof, may constitute forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “advance,” “broaden,” “build,” “deliver,” and “expand,” and include statements argenx makes regarding its new era of innovation in immunology; its advancement of its Vision 2030, including (1) 5 new molecules in Phase 3; (2) 10 labeled indications; and (3) 50,000 patients on treatment, supported by its 2025 execution; its 2026 strategic priorities, including its goals to: (1) impact more patients with VYVGART through delivery of broadest MG label, AIM and ITP Phase 3 readouts, and expansion into rheumatology; (2) shape long-term future of FcRn, including advancement of combination approaches and 3 clinical-stage FcRn molecules; and (3) deliver the next wave of innovation, including first empa Phase 3 readout (MMN), 4 Phase 3 molecules, and 10 clinical molecules; its commitment to key expansion opportunities in autoimmune myositis and multifocal motor neuropathy, including redefining biology, treatment, and patient outcomes; its investment in sustainable innovation; its expected timing of its sBLA submission by Q3 2026 based on its positive data from the ADAPT-OCULUS Phase 3 Clinical Trial in ocular MG; its belief that its prefilled syringe launch is increasing patient impact and broadening prescriber base; its commitment to building durable leadership with the broadest label in MG, with an expected total addressable market of 60,000 U.S. MG patients in 2030, as well as its redefinition of patient outcomes through its (1) expected launch in seronegative MG; (2) Ocular MG Phase 3 readout; (3) empowerment of HCP treatment choice; and (4) combination of empasiprubart and efgartigimod; and its clear path to CIDP market expansion by redefining: (1) treatment through evidence generation and HCP prescriber growth and (2) patient outcomes through its biomarker exploration and progression of multiple mechanisms of action. 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, including tariffs, export controls, sanctions and other regulations on its 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 (the “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 presentation, including any forward-looking statements, except as may be required by law. This presentation contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. 2
Advancing Vision 2030 10 New Molecules Entered Pipeline 4 Ongoing Registrational Studies ~19K Patients Treated Globally* 5 10 50 New Molecules in Phase 3 Patients on TreatmentK Labeled Indications VISION 2030 Michele, CIDP Patient Execution in 2025
2026 Strategic Priorities Impact More Patients with VYVGART Deliver Next Wave of Innovation Deliver broadest MG label AIM and ITP Phase 3 readouts Expand into rheumatology Shape Long-Term Future of FcRn 3 Clinical-stage FcRn molecules Advance combination approaches First empa Phase 3 readout (MMN) 4 Phase 3 molecules 10 Clinical-stage molecules 4
-5 -4.5 -4 -3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 BL W1 W2 W3 W4 W5 W6 W7 W8 ADAPT-SERON* -5 -4.5 -4 -3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 BL W1 W2 W3 W4 W5 W6 W7 W8 W10 ADAPT* -5 -4.5 -4 -3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 BL W1 W2 W3 W4 W5 W6 W7 ADAPT-OCULUS* M e a n C h a n g e f ro m B L i n M G -A D L M e a n C h a n g e f ro m B L i n M G -A D L M e a n C h a n g e f ro m B L i n M G II ( P R O ) O c u la r Confirms IgG Mediated Pathogenesis of Disease Across Subtypes Data Support Broadest Label in MG Placebo Efgartigimod * ADAPT: AChR-Ab seropositive gMG patients only, ADAPT-SERON: AChR-Ab seronegative gMG patients only, ADAPT-OCULUS: AChR-Ab seropositive and seronegative oMG patients
6 Registrational Readouts Over Next 24 Months Phase 3 Data Readouts Sjogren’s Disease Myositis ITP CIDP MMN EFGARTIGIMOD EMPASIPRUBART AChR- gMG (MuSK+, LRP4+, triple seronegative) PDUFA date of May 10, 2026 Decision on Approval 2H 2027 3Q 2026 4Q 2026 2H 2027 4Q 2026 6
Innovation Model Generating World-Class Pipeline ApprovedRegistrationalPoCPhase 1IIP/Preclinical Seronegative Ocular MG ITP Graves’ Disease Sjogren’s Disease Myositis MMN CIDP CMS ARGX-213 25 Active IIP programs Spanning neurology, rheumatology, renal and skin targets ARGX-118 (Galectin) ARGX-124 (FcRn) ARGX-125 TSP-101 (Fn14) AMR Scleroderma AIE DGF SMA IgA Nephropathy ARGX-109 (IL6) Efgartigimod Empasiprubart Adimanebart Other PROGRAMS ARGX-213 ARGX-121 ARGX-109 Target of 1 IND per year 7
ADAPT-OCULUS Phase 3 Study MGFA Class I MGII (PRO) ocular score of ≥6 at screening & Baseline On a stable dose of current treatment (CT) for MG Screening Open Label ExtensionDouble-Blinded Treatment Period 7 wk≤5 wk ≤104 wk 1000mg efgartigimod PH20 SC+ CT 4-week follow-up 4-week follow-up* Week 0 1 2 3 Week 0 1 2 3 Placebo PH20 SC + CT 1000mg efgartigimod PH20 SC+ CT 4-week follow-up 4-week follow-up efgartigimod PH20 SC Treatment Placebo Treatment 3-week dosing 3-week dosing 3-week dosing 3-week dosing TREATMENT CYCLES141 Patients entered study * From cycle 3 onwards, participants may be retreated as needed based on clinical effect, with minimal period of 1 week between cycles Primary Endpoint: Change in MGII PRO ocular score from baseline to day 29
Positive Ocular MG Data Support MG Label Expansion First registrational study in oMG Study met primary endpoint (p=0.012) 2.05-point placebo-adjusted improvement in MGII PRO No new safety concerns identified -5 -4.5 -4 -3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 BL W1 W2 W3 W4 W5 W6 W7 ADAPT-OCULUS* M e a n C h a n g e f ro m B L i n M G II ( P R O ) O c u la r Placebo Efgartigimod *AChR-Ab seropositive and seronegative oMG patients
Product Net Sales of $1.3 billion in Q4 Q4 2025: growth of 14% vs Q3 2025 *All growth is operational and excludes the impact of FX (in millions of $) Q4 2025 Q3 2025 Growth QoQ % Growth * US 1,087 964 124 13% Japan 63 60 3 9% RoW 110 94 15 16% China supply 26 9 17 192% Total 1,286 1,127 159 14% Total ex-China 1,260 1,118 142 13% (in millions of $) Q4 2025 Q4 2024 Growth YoY % Growth * US 1,087 649 438 68% Japan 63 27 36 134% RoW 110 49 61 108% China supply 26 12 14 113% Total 1,286 737 549 74% Q4 2025: growth of 74% vs Q4 2024Product Net Sales by Quarter *Net sales growth % excludes the impact FX Full Year 2025 Product Net Sales of $4.2 billion Year-over-Year Growth of 90%* Q2’22 Q3’22 Q4’22 Q1’23 Q2’23 Q3’23 Q4’23 Q1’24 Q2’24 Q3’24 Q4’24 Q1’25 Q2’25 Q3’25 Q4’25Q1’22 75 131 173 218 269 329 374 398 478 573 737 790 949 1,127 1,286 21 China RoW Japan US $’m
Q4 2025 Financial Summary Financial Strength to Invest in Sustainable Innovation (in million of $) 2025 2024 2025 2024 Product net sales 1,286 737 4,151 2,186 Other operating income 36 24 97 66 Total operating income 1,322 761 4,248 2,252 Cost of sales (150) (73) (451) (227) Research and development expenses (372) (297) (1,364) (983) Selling, general and administrative expenses (430) (286) (1,367) (1,055) Loss from investment in a joint venture (4) (2) (12) (8) Total operating expenses (955) (658) (3,194) (2,274) Operating profit/(loss) 368 103 1,054 (22) Financial income 45 39 163 158 Financial expense (1) (1) (4) (2) Exchange (losses)/gains (8) (55) 66 (48) Profit for the period before taxes 403 87 1,279 85 Income tax benefit 130 688 13 748 Profit for the period 533 774 1,292 833 Comparative figures have been presented to be consistent with the one adopted in the current period with respect to the combination of co llaboration revenue and other operating income. Three months ended Twelve months ended December 31 December 31 $1.1 billion in operating income in 2025, marking first year of operating profitability (in million of $) 2025 2024 2025 2024 Product net sales 1,286 737 4,151 2,186 Other operating income* 36 24 97 66 Total operating income 1,322 761 4,248 2,252 Cost of sales (150) (73) (451) (227) Research and development expenses (372) (297) (1,364) (983) Selling, general and administrative expenses (430) (286) (1,367) (1,055) Loss from investment in a joint venture (4) (2) (12) (8) Total operating expenses (955) (658) (3,194) (2,274) Operating profit/(loss) 368 103 1,054 (22) Financial income 45 39 163 158 Financial expense (1) (1) (4) (2) Exchange (losses)/gains (8) (55) 66 (48) Profit for the period before taxes 403 87 1,279 85 Income tax benefit 130 688 13 748 Profit for the period 533 774 1,292 833 Three months ended Twelve months ended December 31 December 31
Innovation has no value unless it provides meaningful benefit to patients
20% YoY increase in new prescribers >4,700 Prescribers in the US NEW PRESCRIBER AND PATIENT GROWTH Prefilled Syringe Launch is Increasing Patient Impact and Broadening Prescriber Base 70% Source: argenx market research Achieved Blockbuster Status as of 3Q 2025 MG EXPANSION Earlier Line Patients #1 PRESCRIBED BIOLOGIC VYVGART drove 60% Growth in overall MG biologics share CIDP EXPANSION Patients directly from orals As of 4Q 2025 Financial Results Mary Beth, MG Patient 13
Building Durable Leadership with the Broadest Label in MG Launch in Seronegative MG* Ocular MG Phase 3 Readout Limited current treatment options First and only development in Ocular MG * Pending decision on approval Redefine Patient Outcomes U.S. Addressable MG Patients 17K +11K +7K +25K 60K Seronegative Ocular Growth in Biologics Share of Market Combination Empasiprubart & efgartigimod Generating real world evidence Empowering HCP Treatment Choice Addressable Market at Launch Total Addressable Market in 2030 14
Roadmap to CIDP Market Expansion Evidence Generation ADHERE+ Functional Benefit 42K 24K 12K Total Treated Patients Addressable Market at Launch Total Diagnosed Patients HCP Prescriber Growth Biomarker Exploration IgG, IgM Autoantibodies Progressing Multiple MOAs Co-positioning VYVGART & Empasiprubart Redefine Treatment Redefine Patient Outcomes 15
HumilityInnovation ExcellenceCo-Creation Empowerment We are on a bold mission