Positive Phase III ADAPT OCULUS Result in Ocular MG
ADAPT OCULUS met its primary endpoint (MGII ocular score) with VYVGART Hytrulo showing a mean 4.04-point improvement vs 1.99 for placebo (p=0.012). No new safety signals were observed and argenx plans to file an sBLA, expanding the label to ocular myasthenia gravis.
Seronegative MG Data and Upcoming PDUFA
Recent positive seronegative MG results (earlier readout) support label expansion; the company has a seronegative PDUFA date of May 10 and estimates seronegative expansion adds ~11,000 patients to the addressable market.
Strong Commercial Revenue Growth
Product net sales were $1.3 billion in Q4 and $4.2 billion for full year 2025, representing 90% year-over-year growth. U.S. product net sales grew 68% year-over-year in Q4.
First Year of Annual Operating Profitability
argenx reported operating profit of $367 million in Q4 and $1.1 billion for the full year 2025, with profit of $533 million for the quarter and $1.3 billion for the year.
Strong Cash Position
Cash, cash equivalents and current financial assets totaled $4.4 billion at the end of Q4, an increase of more than $1 billion over the year, supporting continued investment in commercial growth and R&D.
Growing Patient and Prescriber Base
Approximately 19,000 patients are on treatment globally at year-end 2025. The prefilled syringe (PFS) launch has driven adoption, contributing to over 4,700 prescribers and additional new prescribers since the PFS launch.
Commercial Momentum in MG and CIDP
VYVGART is described as the fastest-growing and #1 prescribed biologic in MG: 6 out of 10 MG patients starting a biologic start with VYVGART, and 70% of VYVGART patients are switching from orals. CIDP launch is earlier but growing; ~85% of CIDP patients are switching from IVIg and UnitedHealthcare coverage for PFS increased covered lives to over 90%.
Pipeline Depth and Future Programs
argenx highlighted progression of multiple assets: 4 new molecules from the internal innovation program, next-generation FcRn assets ARGX-213 and ARGX-124, first-in-class programs ARGX-121 (IgA) and ARGX-118 (Galectin-10), and plans to progress 3 Phase I programs in 2026. Empasiprubart has a Q4 readout planned in MMN.
Operational and Strategic Planning
Management articulated Vision 2030 priorities: broaden VYVGART adoption and label expansion, advance next-gen FcRn and delivery modalities (auto-injector planned for 2027), and a goal of at least one new pipeline candidate per year to sustain long-term growth.
Tax and Margin Guidance
Year-to-date gross margin remained at 11%. The company reported a net tax benefit for the year and expects an effective tax rate in the low- to mid-teens going forward.