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argenx SE
Interim / Quarterly Report • Jul 31, 2025
6221_ir_2025-07-31_f39ecf02-f0bd-4952-96ff-4a06cf9babb1.pdf
Interim / Quarterly Report
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2025 Half-Year Financial Report
Table of Contents
| Management report | 2 | |
|---|---|---|
| 1 | Main events in the first six months of 2025 | 2 |
| 2 | Financial highlights | 4 |
| 3 | Risk factors | 5 |
| 4 | Forward-looking statements | 5 |
| 5 | Statement of the board of directors | 6 |
| Unaudited condensed consolidated interim financial statements | 7 | |
| Unaudited condensed consolidated interim statements of financial position | 7 | |
| Unaudited condensed consolidated interim statements of profit or loss | 9 | |
| Unaudited condensed consolidated interim statements of comprehensive income or loss | 10 | |
| Unaudited condensed consolidated interim statements of cash flows | 11 | |
| Unaudited condensed consolidated interim statements of changes in equity | 12 | |
| Notes to the unaudited condensed consolidated interim financial statements |
13 | |
| 1 | General information about the Company | 13 |
| 2 | Statement of compliance and basis of preperation | 13 |
| 3 | Material accounting policy information | 13 |
| 4 | Inventories | 14 |
| 5 | Trade and other receivables | 14 |
| 6 | Financial assets - Current | 14 |
| 7 | Cash and cash equivalents | 15 |
| 8 | Share capital and share premium | 15 |
| 9 | Share-based payments | 15 |
| 10 | Trade and other payables | 17 |
| 11 | Segment reporting | 18 |
| 12 | Research and development expenses | 18 |
| 13 | Selling, general and administrative expenses | 19 |
| 14 | Income taxes | 19 |
| 15 | Earnings per share | 19 |
| 16 | Related party transactions | 20 |
| 17 | Commitments | 20 |
| 18 | Events after the balance sheet date | 21 |
Management Report
1 Main events in the first six months of 2025
FIRST QUARTER OF 2025
Refer to our Q1 2025 press release.
SECOND QUARTER OF 2025 AND RECENT BUSINESS UPDATE
"We continue to make meaningful progress towards our Vision 2030, advancing bold innovation that has already reached more than 15,000 patients globally" said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "VYVGART is delivering strong growth across all indications, formulations and regions. We are still in the early stages of capturing the full market opportunity in MG and CIDP, with the recent launch of the VYVGART SC prefilled syringe driving demand from new patients and prescribers. In MG, we are shaping the market as the fastest growing biologic, moving earlier in the patient treatment paradigm, and working toward the broadest possible label. In CIDP, we continue to see consistent patient growth, with ample runway to reach the 12,000 patients in the U.S. who remain inadequately controlled on standard of care. This is just the beginning of the larger growth opportunity ahead. With six registrational and six proof-of-concept readouts expected by the end of 2026, we are executing on our proven innovation playbook that is delivering pipeline-in-a-product opportunities aimed at transforming care for patients with high unmet need."
Advancing Towards Vision 2030
argenx has established its strategic priorities to advance Vision 2030, aiming to treat 50,000 patients globally with its medicines, secure 10 labeled indications across all approved medicines, and advance five pipeline candidates into Phase 3 development by 2030.
Expand global VYVGART opportunity and launch VYVGART SC as prefilled syringe
VYVGART® (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-and-only IgG Fcantibody fragment that targets the neonatal Fc receptor (FcRn). It is approved 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., Japan, China, and the EU. The VYVGART-SC prefilled syringe (PFS) is now approved for use in the U.S. and EU.
- Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of \$1,739 million in the first six months of 2025
- – Strong underlying fundamentals across key patient and prescriber metrics with 98% operational growth in product net sales year-over-year from the first six months of 2024
- First patient dosed in Germany following European Commission (EC) approval for VYVGART-SC (vial and PFS) for CIDP
- PFS decision on approval for gMG and CIDP expected in Japan and Canada by end of year
- Evidence generation through label-enabling studies:
- – Topline results expected in second half of 2025 for seronegative gMG (ADAPT-SERON) and first half of 2026 for ocular MG (ADAPT OCULUS)
- – Topline results expected in second half of 2026 to support FDA submission of VYVGART IV for primary ITP (ADVANCE-NEXT)
Execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 to advance the next wave of launches
argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple first-in-class product candidates with potential across high-need indications.
Efgartigimod Development
Efgartigimod is being studied across 15 severe autoimmune diseases, highlighting the broad potential of FcRn biology in neurology, rheumatology, and beyond.
- Registrational studies are currently ongoing in idiopathic inflammatory myopathies (IIM or myositis), thyroid eye disease (TED), and Sjögren's disease
- – Topline results from ALKIVIA study evaluating three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS) and dermatomyositis (DM)) expected in second half of 2026
- – Topline results from two registrational UplighTED studies (TED) expected in second half of 2026
- – Topline results from registrational UNITY study (Sjögren's disease) expected in 2027
- Proof-of-concept studies ongoing in lupus nephritis (LN), systemic sclerosis (SSc) and antibody mediated rejection (AMR); topline results expected for LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027
Empasiprubart Development
Empasiprubart, a first-in-class, humanized, monoclonal antibody that specifically binds to C2, is currently being evaluated in four indications. These include registrational studies in multifocal motor neuropathy (MMN) and CIDP, and proof-of-concept studies in delayed graft function (DGF) and DM.
- Topline results from registrational EMPASSION study (MMN) evaluating empasiprubart head-to-head versus IVIg expected in second half of 2026
- Registrational EMVIGORATE study ongoing in CIDP evaluating empasiprubart head-to-head versus IVIg
- Topline results expected for DGF in the second half of 2025 and for DM in first half of 2026
ARGX-119 Development
ARGX-119, a first-in-class agonist antibody that targets muscle-specific kinase (MuSK), is being evaluated in congenital myasthenic syndromes (CMS), amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy (SMA).
- Registrational study to start in CMS in 2026 following positive Phase 1b proof-of-concept data
- Phase 2a proof-of-concept study ongoing in ALS; topline results expected in first half of 2026
- SMA proof-of-concept study on track to start by end of year
- ARGX-119 R&D webinar to be hosted on September 16, 2025
Advance four new pipeline molecules and generate sustainable value through continued investment in Immunology Innovation Program
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 biology; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed.
- • Phase 1 results from ongoing ARGX-109 study expected in second half of 2025, and from ongoing ARGX-213 and ARGX-121 studies expected in first half of 2026
- Entered strategic collaboration with Unnatural Products (UNP) to expand argenx discovery capabilities into the oral peptide space. This partnership reinforces argenx's commitment to enhance the patient experience and advance its pipeline of precision therapies.
2 Financial highlights
Total operating income for the six months ended June 30, 2025, was \$1,775 million compared to \$902 million for the same period in 2024, and mainly consists of:
- Product net sales of VYVGART and VYVGART SC for the six months ended June 30, 2025, were \$1,739 million compared to \$876 million for the same period in 2024.
- Other operating income for the six months ended June 30, 2025, was \$36 million compared to \$26 million for the same period in 2024. The other operating income for the six months ended June 30, 2025 and 2024, primarily relates to research and development tax incentives and payroll tax rebates.
Total operating expenses for the six months ended June 30, 2025 were \$1,435 million compared to \$1,041 million for the same period in 2024, and mainly consist of:
- Cost of sales for the six months ended June 30, 2025, was \$192 million compared to \$96 million for the same period in 2024. The cost of sales was related to the sale of VYVGART and VYVGART SC.
- Research and development expenses for the six months ended June 30, 2025, were \$637 million compared to \$450 million for the same period in 2024. The research and development expenses mainly relate to:
- – the clinical development and expansion of efgartigimod in 15 severe autoimmune diseases;
- – the ramp-up of studies for the development of empasiprubart into MMN, DGF, DM and CIDP;
- – the investments for ARGX-119 in proof-of-concept studies ongoing in ALS, CMS and SMA; and
- – other discovery and preclinical pipeline candidates.
- Selling, general and administrative expenses for the six months ended June 30, 2025, were \$601 million compared to \$492 million for the same period in 2024. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the global commercialization of VYVGART franchise, and personnel expenses.
Financial income for the six months ended June 30, 2025, was \$76 million compared to \$78 million for the same period in 2024.
Exchange gains for the six months ended June 30, 2025, were \$76 million compared to \$27 million of exchange losses for the same period in 2024. 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, 2025, consisted of \$74 million of income tax expense compared to \$57 million of income tax benefit for the same period in 2024. Income tax expense for the six months ended June 30, 2025, consists of \$70 million of current income tax expense and \$4 million of deferred tax expense, compared to \$16 million of current income tax expense and \$72 million of deferred tax benefit for the comparable prior period.
Profit for the period of six months ended June 30, 2025 was \$415 million compared to a loss of \$33 million for the same period in 2024. On a per weighted average share basis, the basic profit per share was \$6.80 compared to a loss per share of \$0.55 for the six months ended June 30, 2025 and 2024, respectively.
Cash flow from operating activities for the six months ended June 30, 2025 was \$362 million compared to a cash flow used in operating activities for the same period in 2024 of \$126 million.
3 Risk factors
We refer to the description of risk factors in the 2024 annual report, pp. 81-118 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. 1-29. In summary, the principal risks and uncertainties faced by us relate to: commercialization of our products and product candidates, including new indications, development and clinical testing of our products and product candidates, dependence on third parties, government regulations, financial position, business and industry, intellectual property, our organization and operations.
We also refer to the description of our financial risk management given in the 2024 annual report, pp. 278-281, 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," "committed," "continue," "expand," "expect," "growth," and "progress" and include statements argenx makes concerning its innovation agenda and growth strategy, including (i) its Vision 2030 to reach 50,000 patients globally across 10 labeled indications and to advance fix pipeline candidates into Phase 3 development by 2030 across efgartigimod, empasiprubart and ARGX-119 to create significant opportunity to expand into new therapeutic areas and reach broader patient populations and (ii) its goal to transform care for patients with high unmet need; its confidence regarding its growth trajectory; its commitment to improving the lives of people suffering from severe autoimmune diseases; its expectation regarding the insights from proof-of-concept and registrational studies across various programs; the advancement of anticipated clinical development, data readouts and regulatory milestones and plans, including: (1) the PFS decision on approval for gMG and CIDP expected in Japan and Canada by end of 2025, (2) topline results for seronegative gMG (ADAPT-SERON) expected in second half of 2025 and for ocular and pediatric MG (ADAPT-OCULUS, JR) expected in first half of 2026, (3) topline results for ADVANCE-NEXT to support FDA submission of VYVGART IV for primary ITP expected in second half of 2026, (4) new therapeutic areas and ongoing registrational studies in three subsets of myositis, thyroid eye disease (TED), and Sjögren's disease, with topline results from (a) ALKIVIA expected in second half of 2026, (b) two registrational UplightTED studies expected in second half of 2026 and (c) registrational UNITY study expected in 2027, (5) proof-ofstudies ongoing in LN, SSc and AMR, with topline results expected in fourth quarter of 2025, second half of 2026 and 2027, respectively, (6) its plans to develop empasiprubart, including (a) registrational EMPASSION study in MMN, with topline results expected in second half of 2026, (b) registrational EMVIGORATE study in CIDP, expected to start in first half of 2025 and (c) topline results for DGM and DM expected in second half of 2025 and first half of 2026, respectively, (7) its plans to develop ARGX-119, including: (a) the registrational study to start in CMS in 2026; (b) Phase 2a proof-of-concept study in ALS, with topline results expected in first half of 2026; and (c) SMA proof-ofconcept study; and (8) its plans to advance four new pipeline molecules and generate sustainable value through continue investment in its IIP, through (a) ongoing studies for ARGX-213 and ARGX-121, with results expected in first half of 2026, (b) ARGX-109, with Phase 1 results expected in second half of 2025, and (c) a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forwardlooking 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 costeffective; 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.
5 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, 2025, prepared in accordance with IFRS® Accounting Standards (IFRS) namely IAS 34 "Interim Financial Reporting" 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
Unaudited condensed consolidated interim financial statements
Unaudited condensed consolidated interim statements of financial position
| As of | ||||
|---|---|---|---|---|
| June 30, | December 31, | |||
| (in thousands of \$) | Note | 2025 | 2024 | |
| Assets | ||||
| Non-current assets | ||||
| Property, plant and equipment | 45,795 | 43,517 | ||
| Intangible assets | 218,977 | 181,445 | ||
| Deferred tax assets | 14 | 899,607 | 924,299 | |
| Research and development incentive receivables | 100,467 | 94,854 | ||
| Investment in a joint venture | 16 | 10,681 | 9,268 | |
| Prepaid expenses | 23,643 | 23,643 | ||
| Other non-current assets | 46,683 | 42,393 | ||
| Total non-current assets | 1,345,853 | 1,319,419 | ||
| Current assets | ||||
| Inventories | 4 | 340,621 | 407,233 | |
| Prepaid expenses | 362,715 | 187,948 | ||
| Trade and other receivables | 5 | 1,197,070 | 904,471 | |
| Research and development incentive receivables | 1,157 | 4,625 | ||
| Financial assets | 6 | 1,842,200 | 1,878,890 | |
| Cash and cash equivalents | 7 | 2,085,976 | 1,499,936 | |
| Total current assets | 5,829,739 | 4,883,103 | ||
| Total assets | 7,175,592 | 6,202,522 |
| As of | ||||
|---|---|---|---|---|
| June 30, | December 31, | |||
| (in thousands of \$) | Note | 2025 | 2024 | |
| Equity and Liabilities | ||||
| Equity | 8 | |||
| Equity attributable to owners of the parent | ||||
| Share capital | 7,264 | 7,227 | ||
| Share premium | 6,025,789 | 5,948,916 | ||
| Translation differences | 133,348 | 126,832 | ||
| Accumulated losses | (1,156,977) | (1,571,804) | ||
| Other reserves | 1,086,328 | 987,112 | ||
| Total equity | 6,095,752 | 5,498,283 | ||
| Non-current liabilities | ||||
| Provisions for employee benefits | 2,368 | 1,803 | ||
| Lease liabilities | 35,568 | 32,520 | ||
| Total non-current liabilities | 37,936 | 34,323 | ||
| Current liabilities | ||||
| Lease liabilities | 7,584 | 6,533 | ||
| Trade and other payables | 10 | 1,016,160 | 649,993 | |
| Tax liabilities | 18,160 | 13,390 | ||
| Total current liabilities | 1,041,904 | 669,916 | ||
| Total liabilities | 1,079,840 | 704,239 | ||
| Total equity and liabilities | 7,175,592 | 6,202,522 | ||
Unaudited condensed consolidated interim statements of profit or loss
| Six Months Ended | ||||
|---|---|---|---|---|
| June 30, | ||||
| (in thousands of \$ except per share data) | Note | 2025 | 2024 | |
| Product net sales | 11 | 1,738,644 | 875,918 | |
| Other operating income* | 35,913 | 26,023 | ||
| Total operating income | 1,774,557 | 901,941 | ||
| Cost of sales | 4 | (191,552) | (95,561) | |
| Research and development expenses | 12 | (636,767) | (450,255) | |
| Selling, general and administrative expenses | 13 | (601,150) | (491,694) | |
| Loss from investment in a joint venture | (5,087) | (3,313) | ||
| Total operating expenses | (1,434,556) | (1,040,823) | ||
| Operating profit/(loss) | 340,001 | (138,882) | ||
| Financial income | 75,517 | 77,828 | ||
| Financial expense | (2,261) | (1,084) | ||
| Exchange gains/(losses) | 76,003 | (27,215) | ||
| Profit/(loss) for the period before taxes | \$ 489,260 |
\$ | (89,353) | |
| Income tax (expense)/benefit | 14 | (74,433) | 56,822 | |
| Profit/(loss) for the period | \$ 414,827 |
\$ | (32,531) | |
| Profit/(loss) for the period attributable to: | ||||
| Owners of the parent | 414,827 | (32,531) | ||
| Weighted average number of shares used for basic profit/(loss) per share | 15 | 61,034,202 | 59,400,217 | |
| Basic profit/(loss) per share (in \$) | 15 | 6.80 | (0.55) | |
| Weighted average number of shares used for diluted profit/(loss) per share | 15 | 65,653,007 | 59,400,217 | |
| Diluted profit/(loss) per share (in \$) | 15 | 6.32 | (0.55) |
The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.
**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.
Unaudited condensed consolidated interim statements of comprehensive income or loss
| Six Months Ended | ||||
|---|---|---|---|---|
| June 30, | ||||
| (in thousands of \$) | Note | 2025 | 2024 | |
| Profit/(loss) for the period | 414,827 | (32,531) | ||
| Items that may be reclassified subsequently to profit or loss, net of tax | ||||
| Currency translation differences, arisen from translating foreign activities | 6,516 | (2,608) | ||
| Items that will not be reclassified subsequently to profit or loss, net of tax | ||||
| Fair value gain/(loss) on investments in equity instruments designated as FVTOCI | 4,989 | (5,682) | ||
| Other comprehensive income/(loss), net of income tax | 11,505 | (8,290) | ||
| Total comprehensive profit/(loss) attributable to: | ||||
| Owners of the parent | 426,332 | (40,821) |
Unaudited condensed consolidated interim statements of cash flows
| Six Months Ended | |||
|---|---|---|---|
| June 30, | |||
| (in thousands of \$) | Note | 2025 | 2024 |
| Operating profit/(loss) | 340,001 | (138,882) | |
| Adjustments for non-cash items | |||
| Amortization of intangible assets | 6,309 | 4,956 | |
| Depreciation of property, plant and equipment | 6,954 | 3,667 | |
| Provisions for employee benefits | 480 | 143 | |
| Expense recognized in respect of share-based payments | 9 | 110,794 | 102,381 |
| Fair value gains on financial assets at fair value through profit or loss | – | (445) | |
| Loss from investment in a joint venture | 16 | 5,087 | 3,313 |
| Other non-cash expenses | 30,582 | 8 | |
| 500,207 | (24,859) | ||
| Movements in current assets/liabilities | |||
| (Increase)/decrease in trade and other receivables | 5 | (359,631) | (97,612) |
| (Increase)/decrease in inventories | 4 | 35,001 | (16,072) |
| (Increase)/decrease in other current assets | (170,209) | (45,821) | |
| Increase/(decrease) in trade and other payables | 10 | 359,541 | 76,710 |
| Movements in non-current assets/liabilities | |||
| (Increase)/decrease in other non-current assets | 7,116 | (18,139) | |
| Net cash flows from/(used) in operating activities, before interest and taxes | 372,025 | (125,793) | |
| Interest paid | (664) | (157) | |
| Income taxes (paid)/received | 14 | (9,515) | 1,294 |
| Net cash flows from/(used) in operating activities | 361,846 | (124,656) | |
| Purchase of intangible assets | (43,841) | (21,500) | |
| Purchase of property, plant and equipment | (5,207) | (811) | |
| Purchase of current financial assets | 6 | (1,108,938) | (1,108,410) |
| Sale of current financial assets | 6 | 1,154,260 | 568,410 |
| Interest received | 72,530 | 48,552 | |
| Investment in a joint venture | 16 | (6,500) | – |
| Net cash flows from/(used) in investing activities | 62,304 | (513,759) | |
| Principal elements of lease payments | (1,012) | (3,604) | |
| Payment of employee withholding taxes relating to restricted stock unit awards | (4,514) | (1,792) | |
| Proceeds from exercise of stock options | 79,016 | 45,470 | |
| Net cash flows from financing activities | 73,490 | 40,074 | |
| Increase/(decrease) in cash and cash equivalents | 497,640 | (598,341) | |
| Cash and cash equivalents at the beginning of the period | 7 | 1,499,936 | 2,048,844 |
| Exchange gains/(losses) on cash and cash equivalents | 88,400 | (12,256) | |
| Cash and cash equivalents at the end of the period | 7 | 2,085,976 | 1,438,247 |
Unaudited condensed consolidated interim statements of changes in equity
| Attributable to owners of the parent | ||||||||
|---|---|---|---|---|---|---|---|---|
| Fair value | ||||||||
| Share-based | movement on | |||||||
| payment and | investment in | |||||||
| income tax | equity | Total equity | ||||||
| deduction on | instruments | attributable to | ||||||
| Share | Accumulated | Translation | share-based | designated as | owners of the | |||
| (in thousands of \$) | Share capital | premium | losses | differences | payments | FVTOCI | parent | Total equity |
| Balance on January 01, 2024 | 7,058 | 5,651,497 | (2,404,844) | 131,543 | 771,725 | (59,472) | 4,097,507 | 4,097,507 |
| Loss for the period | (32,531) | (32,531) | (32,531) | |||||
| Other comprehensive income/(loss) | (2,608) | (5,682) | (8,290) | (8,290) | ||||
| Total comprehensive income/(loss) for the period | – | – | (32,531) | (2,608) | – | (5,682) | (40,821) | (40,821) |
| Income tax benefit from excess tax deductions related to share-based | ||||||||
| payments | 7,013 | 7,013 | 7,013 | |||||
| Share-based payments | 102,544 | 102,544 | 102,544 | |||||
| Exercise of stock options | 60 | 97,736 | 97,796 | 97,796 | ||||
| Ordinary shares withheld for payment of employees' withholding tax liability | (1,792) | (1,792) | (1,792) | |||||
| Balance on June 30, 2024 | 7,118 | 5,747,441 | (2,437,375) | 128,935 | 881,282 | (65,154) | 4,262,247 | 4,262,247 |
| Balance on January 1, 2025 | 7,227 | 5,948,916 | (1,571,804) | 126,832 | 1,047,231 | (60,119) | 5,498,283 | 5,498,283 |
| Profit for the period | 414,827 | 414,827 | 414,827 | |||||
| Other comprehensive income | 6,516 | 4,989 | 11,505 | 11,505 | ||||
| Total comprehensive income for the period | – | – | 414,827 | 6,516 | – | 4,989 | 426,332 | 426,332 |
| Income tax benefit from excess tax deductions related to share-based | ||||||||
| payments | (17,166) | (17,166) | (17,166) | |||||
| Share-based payments | 111,393 | 111,393 | 111,393 | |||||
| Exercise of stock options | 37 | 81,387 | 81,424 | 81,424 | ||||
| Ordinary shares withheld for payment of employees' withholding tax liability | (4,514) | (4,514) | (4,514) | |||||
| Balance on June 30, 2025 | 7,264 | 6,025,789 | (1,156,977) | 133,348 | 1,141,458 | (55,130) | 6,095,752 | 6,095,752 |
Please refer to ''Note 8 Share capital and share premium'' for more information on the share capital.
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 Amsterdam, the Netherlands and its registered office is at Laarderhoogtweg 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 Statement of compliance and basis of preperation
The unaudited condensed consolidated interim financial statements for the six months ended June 30, 2025 have been prepared in accordance with IAS 34 Interim Financial Reporting under IFRS® Accounting Standards (IFRS) as adopted by the European Union (EU-IFRS). The unaudited condensed consolidated interim financial statements should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2024.
All amounts herein are presented in thousands of US dollar (\$), 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 30, 2025.
3 Material accounting policy information
New standards and interpretations applicable for the annual period beginning on January 1, 2025
There were no significant changes in the material accounting policies 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, 2024.
The Company has not adopted new standards and interpretations since the year ended December 31, 2024.
The Company has concluded that the critical accounting judgement applied by the Company as of December 31, 2024 on the recognition of its Deferred Tax Assets does not constitute a critical accounting judgement as of the period ended June 30, 2025.
New standards and interpretations issued, but not yet applicable for the annual period beginning on January 1, 2025
The Group continues to evaluate the impacts of the application of the amendments and new standards being issued on the consolidated financial statements in future periods. We have not early adopted any standard, interpretation, or amendment that has been issued but is not yet effective.
4 Inventories
| As of June 30, | As of December 31, | |
|---|---|---|
| (in thousands of \$) | 2025 | 2024 |
| Raw materials and consumables | 258,076 | 337,832 |
| Inventories in process | 11,957 | 26,357 |
| Finished goods | 70,588 | 43,044 |
| Total inventories | 340,621 | 407,233 |
The cost of inventories, which is recognized under "Cost of sales" on the unaudited condensed consolidated statements of profit or loss, amounted to \$119 million for the six months ended June 30, 2025 (compared to \$76 million for the six months ended June 30, 2024).
5 Trade and other receivables
Trade and other receivables are composed of receivables which are detailed below:
| As of June 30, | As of December 31, | |
|---|---|---|
| (in thousands of \$) | 2025 | 2024 |
| Trade receivables | 1,126,445 | 817,707 |
| Interest receivables | 37,720 | 40,214 |
| Tax receivables | 32,733 | 40,886 |
| Other receivables | 171 | 5,664 |
| Total trade and other receivables | 1,197,070 | 904,471 |
The carrying amounts of trade and other receivables approximate their respective fair values. On June 30, 2025 and December 31, 2024, the Company did not have a material provision for expected credit losses.
6 Financial assets - Current
| As of June 30, | As of December 31, | |
|---|---|---|
| (in thousands of \$) | 2025 | 2024 |
| Term accounts | 1,842,200 | 1,878,890 |
| Total current financial assets | 1,842,200 | 1,878,890 |
On June 30, 2025, the current financial assets included \$117 million (€100 million) held in EUR which could generate a foreign currency exchange gain or loss in the financial results in accordance with the fluctuations of the USD/EUR exchange rate as the Company's functional and reporting currency is USD.
7 Cash and cash equivalents
| As of June 30, | As of December 31, | |
|---|---|---|
| (in thousands of \$) | 2025 | 2024 |
| Money market funds | 2,082,094 | 1,394,409 |
| Term accounts | – | 100,000 |
| Cash and bank balances | 3,882 | 5,527 |
| Total cash and cash equivalents | 2,085,976 | 1,499,936 |
Cash and cash equivalents comprise cash and bank balances, term accounts with an original maturity not exceeding three months, and money market funds that are readily convertible to cash and are subject to an insignificant risk of changes in value.
Cash positions are invested with preferred financial partners, which are considered to be high quality financial institutions with sound credit ratings to reduce credit risk.
On June 30, 2025, cash and cash equivalents included \$429 million (€366 million) held in EUR which could generate a foreign currency exchange gain or loss in the financial results in accordance with the fluctuations of the USD/EUR exchange rate as the Company's functional and reporting currency is USD.
8 Share capital and share premium
On June 30, 2025, the Company's share capital was represented by 61,166,252 shares. All shares were issued, fully paid up and of the same class. The table below summarizes the share issuances as a result of the exercise of stock options and vesting of restricted stock units under the Company's Employee Stock Option Plan, for the period ended June 30, 2025.
| Number of shares outstanding on December 31, 2024 | 60,760,957 |
|---|---|
| Exercise of stock options | 346,001 |
| Vesting of RSUs | 59,294 |
| Number of shares outstanding on June 30, 2025 | 61,166,252 |
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 and/or performance stock units.
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 one ordinary share of the Company upon exercise. The stock options carry neither rights to dividends nor voting rights. Stock options may be exercised at any time from the date of vesting to the date of their expiry.
The stock options granted vest, in principle, as follows:
- 1/3rd of the total stock options granted on the first anniversary of the granting of the stock options; and
- 1/36th 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.
No other conditions are attached to stock options.
Below is an overview of the parameters used in relation to the new grant during the six months ended June 30, 2025:
| Stock options granted in | March 2025 | June 2025 1) |
|---|---|---|
| Number of options granted | 21,469 | 593,475 |
| Average Fair value of options (in \$) 2) | 147.95 - 194.55 | 177.33 - 195.75 |
| Share price (in \$) 2) | 547.67 - 584.66 | 550.61 |
| Exercise price (in \$) 2) | 596.99 | 561.74 |
| Expected volatility | 32.61 - 33.43% % | 31.56 - 31.61% |
| Average Expected option life (in years) | 4.33 - 6.52 | 5.34 - 6.35 |
| Risk-free interest rate | 1.91 - 2.43% % | 2.30 - 2.37% |
| Expected dividends | –% % | –% |
1) In June 2025, the Company granted a total of 593,475 stock options of which 180,620 stock options to Belgian taxed beneficiaries. Belgian taxed beneficiaries can choose between a contractual term of 5 or 10 years. The expected option life ranges between 4.16 and 6.35 years. The fair value per option granted to Belgian taxed beneficiaries at grant date would have ranged from \$153.82 to \$195.75 depending on the accepted terms of the grant. This estimate will be reassessed once the acceptance period of 60 days has passed and the beneficiaries will have made a choice between a contractual term of 5 or 10 years.
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 interim statement of profit or loss totaled \$55 million for the six months ended June 30, 2025 compared to \$70 million for the six months ended June 30, 2024.
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 one ordinary share of the Company upon vesting. The RSUs carry neither rights to dividends nor voting rights. RSUs once converted into ordinary shares, may be sold at any time from the date of vesting, have no expiry date and may be held by the participant without limitation. The fair value of RSUs is based on the closing sale price of our Company's common stock on the day prior to the date of issuance. RSUs vest over a period of four years with 1/4th of the total grant vesting at each anniversary of the date of grant.
RSUs granted to non-executive directors prior to the year ended December 31, 2024 vest over a period of four years with 1/4th of the total grant vesting at each anniversary of the date of grant. RSUs granted to non-executive directors as from the year ended December 31, 2024 vest at the one year anniversary of the grant and are subject to a holding period of three years after vesting. The Company has assessed a reduction in fair value associated to RSUs subject to a holding period.
The total share-based payment expense related to RSUs recognized in the unaudited condensed consolidated interim statements of profit or loss totaled \$56 million for the six months ended June 30, 2025 compared to \$33 million for six months ended June 30, 2024.
9.3 Performance Stock Units (PSUs)
The PSUs are granted to key persons of the Company and its subsidiaries. The PSUs have been granted free of charge. Each employee's PSUs converts into one ordinary share of the Company upon vesting. The PSUs carry neither rights to dividends nor voting rights. PSUs once converted into ordinary shares, may be sold at any time from the date of vesting, have no expiry date and may be held by the participant without limitation. The fair value of PSUs is based on the closing sale price of our Company's common stock on the day prior to the date of issuance.
PSUs vest at the end of their three-year performance period. Pay-out levels depend upon the achievement of performance measures, subject to threshold, target and maximum levels as determined by the Board. PSUs have a maximum upside payout opportunity of 150% of target.
The Company granted 30,360 units of PSUs on June 30, 2025. This is the first grant of PSUs by the Company.
10 Trade and other payables
| As of June 30, | As of December 31, | |
|---|---|---|
| (in thousands of \$) | 2025 | 2024 |
| Trade payables | 531,969 | 342,228 |
| Sales rebates and reserves | 320,234 | 140,474 |
| Short-term employee benefits | 127,720 | 150,818 |
| Other payables | 36,237 | 16,473 |
| Total trade and other payables | 1,016,160 | 649,993 |
The carrying amounts of trade and other payables approximate their respective fair values.
Trade payables correspond primarily to research & development, commercial 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 summarizes the movement in the sales rebates and reserves:
| Distribution fees | |||
|---|---|---|---|
| Rebates and | and product | Total sales rebates | |
| (in thousands of \$) | chargebacks | returns | and reserves |
| Balance on January 1, 2025 | 127,411 | 13,063 | 140,474 |
| Estimate related to current period sales | 355,083 | 49,371 | 404,454 |
| Adjustment for prior year sales | (3,922) | 212 | (3,710) |
| Credits or payments | (185,975) | (44,470) | (230,445) |
| Foreign currency translation differences | 9,975 | (514) | 9,461 |
| Balance on June 30, 2025 | 302,572 | 17,662 | 320,234 |
11 Segment reporting
The Company manages its activities and operates as one business unit which is reflected in its organizational structure and internal reporting. The Company does not distinguish in its internal reporting different segments, neither business nor geographical segments. The chief operating decision-maker is the Board of Directors.
The following table summarizes the product net sales by country of sales based on the country of the entity that recognizes product net sales:
| Six Months Ended | ||
|---|---|---|
| June 30, | ||
| (in thousands of \$) | 2025 | 20241) |
| United States | 1,482,882 | 754,542 |
| Japan | 83,678 | 38,114 |
| China | 32,902 | 16,196 |
| Netherlands | 1,588 | – |
| Rest of the World | 137,594 | 67,066 |
| Total product net sales | 1,738,644 | 875,918 |
1) Comparative figures have been presented to be consistent with the one adopted in the Company's latest Annual Report.
The Company sells its products through a limited number of distributors and wholesalers. Five U.S. customers represent approximately 85% of the product net sales during the six months ended June 30, 2025 (compared to 86% for the same period in 2024).
12 Research and development expenses
| Six Months Ended | ||
|---|---|---|
| June 30, | ||
| (in thousands of \$) | 2025 | 2024 |
| External research and development expenses | 416,448 | 286,038 |
| Personnel expenses | 167,840 | 132,903 |
| BIS expenses | 26,429 | 16,493 |
| Materials and consumables | 3,983 | 2,309 |
| Depreciation and amortization | 5,047 | 2,769 |
| Other expenses | 17,020 | 9,743 |
| Total research and development expenses | 636,767 | 450,255 |
13 Selling, general and administrative expenses
| Six Months Ended | ||
|---|---|---|
| June 30, | ||
| (in thousands of \$) | 2025 | 2024 1) |
| Personnel expenses | 225,419 | 194,026 |
| Marketing services | 178,240 | 150,341 |
| Professional fees | 105,550 | 90,576 |
| BIS expenses | 21,259 | 11,647 |
| Supervisory board | 8,558 | 4,267 |
| Facilities and occupancy expenses | 8,479 | 6,613 |
| Depreciation and amortization | 3,548 | 1,424 |
| Other expenses | 50,097 | 32,800 |
| Total selling, general and administrative expenses | 601,150 | 491,694 |
1) Comparative figures have been presented to be consistent with the one adopted in the Company's latest Annual Report.
14 Income taxes
The Company recorded an income tax expense of \$74 million for the six months ended June 30, 2025 compared to an income tax benefit of \$57 million for the same period in 2024.
Income tax expense for the six months ended June 30, 2025, consists of \$70 million of current income tax expense and \$4 million of deferred tax expense, compared to \$16 million of current income tax expense and \$72 million of deferred tax benefit for the comparable prior period.
The key elements impacting the effective tax rate for the six months ended June 30, 2025 were primarily the mix of income generated among the jurisdictions in which the Company operates and various tax incentives in certain jurisdictions.
15 Earnings per share
| Six Months Ended | ||||
|---|---|---|---|---|
| 30 June, | ||||
| (in thousands of \$ except for shares and EPS) | 2025 | 2024 | ||
| Profit/(loss) for the period | \$ | 414,827 | \$ | (32,531) |
| Weighted average number of shares outstanding | 61,034,202 | 59,400,217 | ||
| Basic profit/(loss) per share (in \$) | 6.80 | (0.55) | ||
| Weighted average number of shares outstanding for purpose of diluted profit/(loss) per share | 65,653,007 | 59,400,217 | ||
| Diluted profit/(loss) per share (in \$) | 6.32 | (0.55) |
Profit/(loss) per ordinary share is calculated by dividing the profit/(loss) for the period by the weighted average number of ordinary shares during the period. Diluted profit/(loss) per share is calculated by adjusting the weighted average number of shares by in the money outstanding dilutive stock options, RSUs and PSUs.
As the Company reported a net loss for the six months ending June 30, 2024, stock options and RSUs had an antidilutive effect rather than a dilutive effect. As such, there is no difference between basic and diluted loss per ordinary share for this periods.
16 Related party transactions
In 2022, the University of Colorado Anschutz Medical Campus and the University of Colorado Health (UCHealth) created an asset-centric spin-off, OncoVerity, Inc (OncoVerity), focused on optimizing and advancing the development of cusatuzumab, a novel anti-CD70 antibody, in acute myeloid leukemia (AML). OncoVerity is an entity of co-creation, combining the extensive translational biology insights from Dr. Clayton Smith, M.D. from the University of Colorado with our experience on the CD70/CD27 pathway. The Company contributed \$6.5 million in 2025 (\$7 million in the year ended December 31, 2024).
The investment has been accounted under IAS 28 Investment in associates and Joint Ventures using the equity method of accounting and has been designated as an "Investment in a joint venture" in the unaudited condensed consolidated interim statements of financial position. The share of net loss resulting from investment in joint ventures is presented in the unaudited condensed consolidated interim statements of profit or loss and the unaudited condensed consolidated interim statements of other comprehensive income or loss in line "Loss from investment in a joint venture". The cash contributions made by the Company to the Joint Venture is reported under Cash flow from investing activities under "Investment in a joint venture" in the unaudited condensed consolidated interim statements of cash flows.
During the six months ended June 30, 2025 a total of 73,091 stock options and 24,742 PSUs were granted to senior management members as a group. During the six months ended June 30, 2025 a total of 5,624 restricted stock units were granted to non-executive board members.
17 Commitments
As of the balance sheet date, there were no commitments signed for the acquisition of property, plant and equipment.
In February 2019, the Company entered into a global collaboration and license agreement with Halozyme Therapeutics., which was later amended in September 2020 and again in September 2024.
Under the terms of the agreement, the Company will pay up to \$70 million to achievement of specific regulatory and sales-based milestones related specifically to its FcRn target. This amount represents the maximum amount that would be paid if all milestones would be achieved but excludes variable royalty payments based on unit sales.
Further, the Company will pay up to \$78 million per other non-FcRn target subject to achievement of specified development, regulatory and sales-based milestones. This amount represents the maximum amount that would be paid per target if all milestones would be achieved but excludes variable royalty payments based on unit sales. The Company has a total of six nominated targets under this agreement including its FcRn target.
The Company's 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 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, the Company has outstanding commitments for efgartigimod under the commercial supply agreements of \$456 million as of June 30, 2025.
The Company has engaged with Fujifilm for large-scale manufacturing of efgartigimod drug substance. The commitments under this commercial supply agreement total \$130 million as of June 30, 2025.
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.