Strong Revenue Growth and Scale
Product net sales of $1.3B in Q4 2025 and $4.2B for full year 2025, representing year-over-year growth of 90%. U.S. Q4 product sales were $1.1B, up 68% year-over-year. Company achieved its first year of annual operating profitability with operating profit of $367M in Q4 and $1.1B for the year, and profit of $533M in Q4 and $1.3B for the full year.
Robust Balance Sheet
Cash, cash equivalents and current financial assets of $4.4B at the end of Q4, representing more than a $1B increase over the year, providing strong capital to invest in commercial expansion and pipeline.
Positive Phase III ADAPT OCULUS Ocular MG Results
Study met primary endpoint (MGII patient‑reported ocular score) with VYVGART Hytrulo showing a mean improvement of 4.04 vs 1.99 for placebo at week 4 (p=0.012). Clear improvements observed in diplopia and ptosis, favorable tolerability and no new safety signals. Company plans to file an sBLA for ocular MG.
Continued MG & CIDP Commercial Momentum
Approximately 19,000 patients on treatment globally at year-end 2025. VYVGART is the fastest-growing and #1 prescribed biologic in MG: 6 out of 10 MG patients starting on a biologic start with VYVGART; 70% of VYVGART patients switched from orals. Prefilled syringe (PFS) launch is a key driver of patient adoption and contributed to >4,700 prescribers (including a dozen new prescribers since PFS launch).
Access Wins Supporting Uptake
Important access win: UnitedHealthcare coverage for the prefilled syringe expanded covered lives to >90%, improving payer access for a key delivery format and supporting adoption in CIDP and MG.
Pipeline Depth and Next-Generation Programs
Advanced immunology pipeline including 4 new molecules from the IIP and next-generation FcRn assets ARGX-213 and ARGX-124. First-in-class candidates progressing (ARGX-121 targeting IgA, ARGX-118 targeting Galectin-10). Company expects to progress 3 Phase I programs in 2026 and has upcoming key readouts including empasiprubart (MMN) readout planned for Q4.
Operational and Strategic Execution
Delivered FY25 combined R&D and SG&A of $2.7B in line with guidance. Management outlines clear strategic priorities (Vision 2030) including label expansions (seronegative PDUFA May 10), new delivery modalities (auto-injector planned for 2027), and a disciplined indication expansion playbook.
Financial Discipline and Tax Position
Year-to-date gross margin ~11% with cost of sales $150M in Q4. Tax for Q4 and full year reflected a net benefit due to nonrecurring items and FX; company expects an effective tax rate in the low- to mid-teens going forward.