argenx Announces Q3 2025 Financial Results and Business Highlights

10/30/2025 – 02:00 AM

$1.13 billion in third quarter global product net sales 

On track to submit seronegative gMG sBLA by year-end and report ADAPT-OCULUS results in 1H26 – supporting pursuit of broadest MG label of any biologic

Five registrational study readouts expected in 2026 from leading immunology pipeline

Management to host conference call today at 1:30 PM CET (8:30 AM ET)

October 30, 2025 7:00 AM CET

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

“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

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    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)  

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