Historic Profitability Secured: argenx Posts First Operating Profit (ARGX Q4 2025 Earnings Call)
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argenx delivered its first full year of operating profitability in fiscal year 2025, driven by surging global adoption of its core immunology biologic VYVGART. The company capped the year with record net sales and a pivotal Phase III clinical trial victory in ocular myasthenia gravis, solidifying its leadership in FcRn-targeted therapeutics.
Commercial Momentum Propels argenx to Historic Operating Profitability
argenx achieved its first annual operating profit of $1.1 billion in company history for the full year of 2025. This historic milestone was propelled by product net sales reaching $4.2 billion. This revenue performance represented a remarkable 90% growth compared to the prior fiscal year.
Capital Strength Positions Company for Continued Immunology Pipelines
To support its long-term strategy, argenx expects its operating expenses to grow in fiscal year 2026 at a percentage rate similar to the 30% growth recorded in the prior year. In 2025, combined R&D and SG&A expenses reached $2.7 billion. CFO Karl Gubitz remarked: 'The strength of our balance sheet allows us to invest with confidence in growing our commercial business as well as our pipeline.'
Phase III Ocular Trial and Prefilled Syringe Expand Patient Access
The company achieved a clinical breakthrough in its Phase III ADAPT OCULUS study of VYVGART Hytrulo in ocular myasthenia gravis. The trial randomized 141 patients to receive either the active biologic or a placebo. The active treatment group demonstrated a mean 4.04 point improvement on the patient-reported ocular score at day 29 compared to a 1.99 point improvement for placebo.
argenx ended the fiscal year with approximately 19,000 patients on treatment globally. U.S. product net sales grew by 68% year-over-year in the fourth quarter, driven by strong prescriber adoption of the newly launched prefilled syringe. This launch was further supported by securing a critical access win in chronic inflammatory demyelinating polyneuropathy, which expanded insurance coverage to the vast majority of covered lives in the U.S. through UnitedHealthcare.
Label Expansion and Pricing Strategy Define long-Term Growth Strategy
During the Q&A session, management highlighted its pricing and expansion strategy for the upcoming seronegative and ocular myasthenia gravis indications. Karl Gubitz stated that the company expects a net price of approximately $225,000 per patient, matching the rate established for generalized disease. These expansions will target significant patient segments, with seronegative myasthenia gravis representing 11,000 addressable U.S. patients and the ocular subindication representing 7,000 eligible patients.
These two additions will position VYVGART to achieve the broadest possible label and reach a total target addressable U.S. population of approximately 60,000 patients. The regulatory PDUFA date for seronegative disease is scheduled for May 10. Additionally, Karen Massey noted that 85% of chronic inflammatory demyelinating polyneuropathy patients currently on therapy are switching from traditional intravenous immunoglobulin infusions.