Argenix SE reported diluted earnings of $8.02 per share for 2025, a 29% beat over the consensus estimate of $6.20. Full‑year revenue reached $4.248 billion, up 90% from $2.25 billion in 2024, and the company achieved its first year of operating profitability with a full‑year operating income of $1.1 billion.
The revenue surge was driven by VYVGART, the company’s flagship FcRn‑blocking therapy. Global sales of the drug rose to $4.2 billion, supported by the launch of a pre‑filled syringe formulation that expanded access in both the generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) markets. In the fourth quarter, revenue of $1.322 billion exceeded the $1.105 billion estimate, reflecting strong demand for the new formulation and a growing patient base of 19,000 worldwide.
Operating income climbed to $1.3 billion in Q4 and $1.1 billion for the full year, marking the first time the company has generated operating profit. The improvement reflects disciplined cost management and the benefits of scale as VYVGART sales accelerate, offsetting the higher cost of goods sold associated with the new syringe format.
In clinical development, the Phase 3 ADAPT OCULUS study of VYVGART in ocular myasthenia gravis met its primary endpoint, providing a data foundation for a planned supplemental Biologics License Application in the United States. The positive topline results broaden the drug’s indication portfolio and reinforce the company’s strategy to expand VYVGART’s market reach.
Argenix’s Vision 2030 strategy underpins these results: the company aims to treat 50,000 patients globally, secure 10 labeled indications, and advance five pipeline candidates into Phase 3 by 2030. The firm’s leadership in the FcRn space and its expanding pipeline position it to capitalize on these growth targets.
"Argenix delivered another standout year of execution in 2025. 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," said CEO Tim Van Hauwermeiren.
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