On October 30, 2025 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported its third quarter 2025 financial results and provided a business update.

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"argenx continues to deliver on our bold innovation agenda, driving transformational impact for patients worldwide," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "This year, we expanded our global reach with VYVGART in two blockbuster indications, advanced five registrational programs, and are on track to complete our goal of four Phase 1 molecules by year-end, reflecting our ongoing investment in innovation. VYVGART is redefining expectations for people living with gMG and CIDP, and we see continued growth potential driven by strong patient demand for better outcomes, earlier use in the treatment paradigm, and our commitment to pursuing the broadest possible labels for our medicines. We aim to leverage the successful innovation playbook of MG and CIDP as we prepare for five registrational readouts next year. Building on this momentum, our pipeline is positioned to expand into new indications and reach tens of thousands more patients—bringing us closer to our Vision 2030 goal."

Vision 2030 Strategic Priorities

argenx is advancing its Vision 2030 strategic priorities, 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.

Expand global VYVGART opportunity

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.

Delivered $1.13 billion in global product net sales in the third quarter of 2025, an increase of $554 million year-over-year and $178 million quarter-over-quarter, reflecting strong fundamentals and continued confidence from patients and prescribers.
VYVGART SC prefilled syringe (PFS) for self-injection approved in Japan in September 2025; Canada decision on approval expected by end of 2025
Supplemental Biologics License Application (sBLA) for VYVGART in three anti-acetylcholine receptor antibody negative (AChR-Ab seronegative) gMG subtypes (MuSK+, LRP4+, triple seronegative) on track for filing with U.S. Food and Drug Administration (FDA) by year-end 2025
Pursuing label expansion through ongoing registrational studies:
Topline results expected in first half of 2026 for ocular MG (ADAPT OCULUS)
Topline results expected in the second half of 2026 for primary ITP (ADVANCE-NEXT)
Expanded partnership with FUJIFILM to include new manufacturing site in North Carolina, strengthening global supply chain and supporting anticipated growth in efgartigimod and pipeline assets
Execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 to advance 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 in severe IgG-mediated autoimmune diseases, highlighting the broad potential of FcRn biology across several therapeutic areas including neurology, rheumatology and endocrinology.

Registrational studies are currently ongoing in two rheumatology indications, including idiopathic inflammatory myopathies (IIM or myositis) 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 UNITY study (Sjögren’s disease) expected in 2027
Registrational study in Graves’ disease (GD) to initiate in first half of 2026, expanding development in thyroid-driven autoimmunity, including ongoing registrational studies in thyroid eye disease (TED)
Topline results from UplighTED studies expected in second half of 2026
Proof-of-concept studies ongoing in systemic sclerosis (SSc) and antibody mediated rejection (AMR)
Topline Phase 2 data from lupus nephritis do not support advancing to registrational study

Empasiprubart Development

Empasiprubart, a first-in-class, monoclonal antibody that specifically binds to C2, is currently being evaluated in three indications, including multifocal motor neuropathy (MMN), CIDP and delayed graft function (DGF).

Topline results from registrational EMPASSION study (MMN) expected in second half of 2026
Registrational EMVIGORATE and EMNERGIZE studies ongoing (CIDP)
Topline data from Phase 2 VARVARA study (DGF) expected around year-end 2025
Stopped development of empasiprubart in DM due to operational challenges with enrollment of proof-of-concept EMPACIFIC study
ARGX-119 Development

ARGX-119, a first-in-class agonist antibody that targets muscle-specific kinase (MuSK), is now a registrational asset following positive proof-of-concept data in congenital myasthenic syndromes (CMS). ARGX-119 is also being evaluated in amyotrophic lateral sclerosis (ALS) and spinal muscular atrophy (SMA).

CMS registrational study on track to start in 2026
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 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 study for ARGX-109 expected to complete by end of 2025; Phase 1 studies for ARGX-213 and ARGX-121 expected to complete in first half of 2026
THIRD QUARTER 2025 FINANCIAL RESULTS

argenx SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended Nine Months Ended
September 30, September 30,
(in thousands of $ except for per share data) 2025 2024 2025 2024
Product net sales $ 1,126,961 $ 572,997 $ 2,865,605 $ 1,448,915
Other operating income* 24,377 15,881 60,290 41,904
Total operating income $ 1,151,338 $ 588,878 $ 2,925,895 $ 1,490,819

Cost of sales $ (109,426) $ (59,072) $ (300,978) $ (154,633)
Research and development expenses (355,651) (235,940) (992,418) (686,195)
Selling, general and administrative expenses (336,291) (277,698) (937,441) (769,392)
Loss from investment in a joint venture (3,776) (1,981) (8,863) (5,294)
Total operating expenses $ (805,144) $ (574,691) $ (2,239,700) $ (1,615,514)

Operating profit/(loss) $ 346,194 $ 14,187 $ 686,195 $ (124,695)

Financial income $ 42,700 $ 40,586 $ 118,217 $ 118,414
Financial expense (993) (676) (3,254) (1,760)
Exchange (losses)/gains (1,848) 33,927 74,155 6,712

Profit/(loss) for the period before taxes $ 386,053 $ 88,024 $ 875,313 $ (1,329)
Income tax (expense)/benefit $ (41,795) $ 3,386 $ (116,228) $ 60,208
Profit for the period $ 344,258 $ 91,410 $ 759,085 $ 58,879
Profit for the period attributable to:
Owners of the parent $ 344,258 $ 91,410 $ 759,085 $ 58,879
Weighted average number of shares used for basic profit per share 61,371,508 60,087,498 61,147,873 59,633,179
Basic profit per share (in $) 5.61 1.52 12.41 0.99
Weighted average number of shares used for diluted profit per share 66,441,326 65,636,686 65,944,952 65,024,955
Diluted profit per share (in $) 5.18 1.39 11.51 0.91
*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 nine months ended September 30, 2025 was $1.2 billion and $2.9 billion, respectively, compared to $0.6 billion and $1.5 billion, respectively, for the same periods in 2024, and mainly consisted of:

Product net sales of VYVGART for the three and nine months ended September 30, 2025, were $1.1 billion and $2.9 billion, respectively, compared to $0.6 billion and $1.4 billion, respectively, for the same periods in 2024.

Other operating income for the three and nine months ended September 30, 2025 was $24 million and $60 million, respectively, compared to $16 million and $42 million, respectively, for the same periods in 2024. The other operating income in these periods primarily related to research and development tax incentives and payroll tax rebates.

Total operating expenses for the three and nine months ended September 30, 2025 were $805 million and $2.2 billion, respectively, compared to $575 million and $1.6 billion, respectively, for the same periods in 2024, and mainly consisted of:

Cost of sales for the three and nine months ended September 30, 2025 was $109 million and $301 million, respectively, compared to $59 million and $155 million, respectively, for the same periods in 2024. The cost of sales related to the sale of VYVGART.

Research and development expenses for the three and nine months ended September 30, 2025 were $356 million and $992 million, respectively, compared to $236 million and $686 million, respectively, for the same periods in 2024. The research and development expenses mainly related to:

Advancing efgartigimod across multiple severe autoimmune indications, supporting ongoing registrational and expansion studies;
Progressing empasiprubart into multiple indications namely in MMN, DGF and CIDP;
Executing studies for ARGX-119 in rare neuromuscular diseases, including a registrational study in CMS and proof-of-concept studies in ALS and SMA; and
Early-stage discovery and preclinical programs to sustain long-term pipeline growth.

Selling, general and administrative expenses for the three and nine months ended September 30, 2025 were $336 million and $937 million, respectively, compared to $278 million and $769 million, 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 nine months ended September 30, 2025 was $43 million and $118 million, respectively, compared to $41 million and $118 million, respectively, for the same periods in 2024.

Exchange losses/gains for the three and nine months ended September 30, 2025 were a $2 million loss and a $74 million gain, respectively, compared to $34 million and $7 million gains, respectively, for the same periods in 2024. Exchange losses/gains were mainly attributable to unrealized exchange rate fluctuations on the cash, cash equivalents and current financial assets denominated in Euros.

Income tax for the three and nine month periods ended September 30, 2025 and 2024 is detailed below:

Three Months Ended Nine Months Ended
30 September, 30 September,
(in millions of $) 2025 2024 2025 2024
Current tax expense $ (52) $ (13) $ (122) $ (29)
Deferred tax benefit 10 17 6 89
Income tax (expense)/benefit $ (42) $ 3 $ (116) $ 60
Profit for the three and nine month periods ended September 30, 2025 was $344 million and $759 million, respectively, compared to $91 million and $59 million, respectively, for the same periods in 2024. On a per weighted average share basis, the basic earnings per share was $12.41 for the nine months ended September 30, 2025 compared to $0.99 for the nine months ended September 30, 2024.

Cash, cash equivalents and current financial assets1 consisted of $2.6 billion in cash and cash equivalents and $1.7 billion in current financial assets which totals $4.3 billion as of September 30, 2025 compared to $1.5 billion in cash and cash equivalents and $1.9 billion in current financial assets which totals $3.4 billion as of December 31, 2024.

FINANCIAL GUIDANCE

The financial guidance on the combined research and development and selling, general and administrative remains unchanged at approximately $2.5 billion.

REMAINING KEY DATES

February 26, 2026: Full-year 2025 Financial Results and Fourth Quarter 2025 Business Update

CONFERENCE CALL DETAILS

The third quarter 2025 financial results and business update will be discussed during a conference call and webcast presentation today at 1:30 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.

(Press release, argenx, OCT 30, 2025, View Source [SID1234657115])