argenx SE (Euronext & Nasdaq: ARGX), a global immunology company focused on improving the lives of people with severe autoimmune diseases, today announced its financial results for the first quarter of 2025 and provided a comprehensive business update.
CEO Statement
“We are delivering on our bold innovation agenda, aligned with our ‘Vision 2030’ to reach 50,000 patients across 10 labeled indications,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “Our commitment to improving patient outcomes is reflected in the continued success of VYVGART, where we are setting new benchmarks for sustained efficacy and safety. The strong fundamentals of our launch strategy are evident in the consistent growth of both patient and prescriber adoption in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Looking ahead, we are excited about the momentum created by the recent U.S. approval of our pre-filled syringe for self-injection, which allows us to reach patients earlier in their treatment journey. With 10 Phase 2 and 10 Phase 3 trials underway across our key programs — efgartigimod, empasiprubart, and ARGX-119 — we are poised to expand into new therapeutic areas and reach broader patient populations. We anticipate meaningful insights from several proof-of-concept and registrational studies by year-end, while also advancing four innovative IND candidates that showcase the depth of our pipeline.”
Advancing Vision 2030
argenx’s Vision 2030 sets the company’s strategic priorities:
- Treat 50,000 patients globally with its medicines
- Secure 10 labeled indications across all approved products
- Advance five pipeline candidates into Phase 3 development by 2030
Expanding the Global VYVGART Opportunity
VYVGART® (IV: efgartigimod alfa-fcab; SC: efgartigimod alfa and hyaluronidase-qvfc) is the first and only targeted IgG Fc-antibody fragment approved in three indications worldwide:
- Generalized myasthenia gravis (gMG) globally
- Primary immune thrombocytopenia (ITP) in Japan
- Chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S., Japan, and China
The VYVGART-SC pre-filled syringe (PFS) is now approved in both the U.S. and EU, enabling strong commercial growth through global expansion, earlier adoption in treatment pathways, and momentum in both gMG and CIDP. Additionally, argenx is broadening its reach with ongoing studies targeting seronegative, ocular, and pediatric MG populations.
Q1 2025 Highlights:
- Global product net sales: $790 million, nearly doubling (99% growth) year-over-year from Q1 2024, and up 7% from Q4 2024
- PFS rollout progress:
- First patients treated with VYVGART-SC PFS for self-injection in the U.S. and Germany
- Positive CHMP recommendation from the EMA for VYVGART-SC (PFS and vial) for CIDP
- Regulatory decisions in Japan and Canada for gMG and CIDP expected by year-end
Upcoming Data Readouts:
- H2 2025: Seronegative gMG (ADAPT-SERON) topline results
- H1 2026: Ocular and pediatric MG (ADAPT-OCULUS, JR) topline results
- H2 2025: Phase 4 switch study in CIDP (IVIg to VYVGART SC)
- H2 2026: ADVANCE-NEXT topline results to support FDA submission for VYVGART IV in ITP
Driving the Next Wave of Launches: 20 Clinical Studies Underway
argenx is advancing a robust immunology pipeline, reinforcing leadership in:
- FcRn biology with efgartigimod
- Complement inhibition with empasiprubart
- MuSK modulation at the neuromuscular junction with ARGX-119
Efgartigimod Development
15 autoimmune diseases in active evaluation, including:
- Registrational studies:
- Myositis subsets (IMNM, ASyS, DM) → topline results H2 2026
- Thyroid eye disease (TED, UplighTED studies) → topline results H2 2026
- Sjögren’s disease (UNITY study) → topline results 2027
- Proof-of-concept studies:
- Lupus nephritis → topline results Q4 2025
- Systemic sclerosis → topline results H2 2026
- Antibody-mediated rejection → topline results 2027
Empasiprubart Development
- Registrational studies:
- Multifocal motor neuropathy (MMN, EMPASSION study) → topline results H2 2026
- CIDP (EMVIGORATE study) → study start H1 2025
- Proof-of-concept studies:
- Delayed graft function (DGF) → topline results H2 2025
- Dermatomyositis → topline results H1 2026
ARGX-119 Development
- Phase 1b (CMS) → topline results H2 2025
- Phase 2a (ALS) → topline results H1 2026
- SMA study on track to begin in 2025
Advancing the Pipeline
argenx’s Immunology Innovation Program (IIP) continues to fuel sustainable growth with four new pipeline candidates:
- ARGX-213 (FcRn)
- ARGX-121 (IgA, first-in-class)
- ARGX-109 (IL-6, key in inflammation)
- A novel sweeping antibody (target undisclosed)
Upcoming milestones:
- ARGX-109 Phase 1 topline: H2 2025
- ARGX-213 and ARGX-121 Phase 1 toplines: H1 2026
First Quarter 2025 Financial Results
| Category | Q1 2025 | Q1 2024 |
|---|---|---|
| Total operating income | $807 million | $413 million |
| Product net sales (VYVGART + SC) | $790 million | $398 million |
| Other operating income | $17 million | $12 million |
| Total operating expenses | $668 million | $506 million |
| Cost of sales | $81 million | $43 million |
| R&D expenses | $309 million | $225 million |
| SG&A expenses | $276 million | $236 million |
| Financial income | $37 million | $39 million |
| Exchange gains/(losses) | $27 million gain | $19 million loss |
| Income tax (expense)/benefit | $33 million expense | $13 million benefit |
| Net profit/(loss) | $169 million profit | $62 million loss |
| Profit/(loss) per share | $2.78 profit | $1.04 loss |
argenx’s strong first quarter results reflect its commitment to transforming the treatment landscape for autoimmune diseases, advancing its innovation pipeline, and building sustainable, long-term growth aligned with Vision 2030.
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.
