Core Insights - argenx SE reported $1.13 billion in global product net sales for Q3 2025, marking a significant increase of $554 million year-over-year and $178 million quarter-over-quarter, indicating strong market performance and confidence from patients and prescribers [1][5][18] - The company is on track to submit a supplemental Biologics License Application (sBLA) for seronegative generalized myasthenia gravis (gMG) by the end of 2025 and anticipates reporting results from the ADAPT-OCULUS study in the first half of 2026, aiming for the broadest MG label of any biologic [1][5][28] - argenx is advancing its Vision 2030 strategic priorities, which include treating 50,000 patients globally, securing 10 labeled indications, and progressing five pipeline candidates into Phase 3 development by 2030 [3][28] Financial Performance - Total operating income for Q3 2025 was $1.2 billion, compared to $0.6 billion in Q3 2024, while total operating expenses were $805 million, up from $575 million in the same period [15][18] - The profit for Q3 2025 was $344 million, significantly higher than the $91 million reported in Q3 2024, with basic earnings per share increasing to $12.41 from $0.99 [19][18] - Cash, cash equivalents, and current financial assets totaled $4.3 billion as of September 30, 2025, compared to $3.4 billion at the end of 2024, reflecting a strong liquidity position [20][31] Product Development and Pipeline - VYVGART, the company's leading product, is approved in three indications, including gMG and CIDP, with ongoing efforts to expand its label through registrational studies [4][5] - Five registrational study readouts are expected in 2026, with ongoing studies in various autoimmune diseases, including ocular MG and primary immune thrombocytopenia (ITP) [5][12] - The company is also advancing multiple first-in-class product candidates, including empasiprubart and ARGX-119, targeting severe autoimmune diseases [7][8][9] Strategic Initiatives - argenx is expanding its global reach with VYVGART and aims to leverage its innovation playbook to drive growth in new indications, targeting tens of thousands more patients [2][5] - The company has expanded its partnership with FUJIFILM to include a new manufacturing site in North Carolina, enhancing its global supply chain [5] - The Immunology Innovation Program (IIP) continues to be a focus for sustainable pipeline growth, with four new pipeline candidates nominated [9][28]

Company Overview - argenx is a global immunology company focused on improving the lives of individuals suffering from severe autoimmune diseases [3] - The company collaborates with leading academic researchers through its Immunology Innovation Program (IIP) to translate immunology breakthroughs into a portfolio of novel antibody-based medicines [3] - argenx has developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker, evaluating its potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines [3] Upcoming Event - Tim Van Hauwermeiren, the Chief Executive Officer of argenx, along with members of the management team, will present at the BofA Securities 2025 Health Care Conference on May 13, 2025, at 4:20 p.m. PT [1] - A live webcast of the presentation will be available on the Investors section of the argenx website, with a replay accessible for approximately 30 days following the event [2]