ARGX-213

February 27, 2025 — argenx SE reported full-year 2024 financial results and a Q4 2024 business update, highlighting continued growth of its VYVGART franchise (efgartigimod; IV and SC). Global product net sales were $737.0 million in Q4 2024 and $2.186 billion for full-year 2024 (vs. $374.4 million and $1.191 billion in 2023). Total operating income was $2.252 billion in 2024, while operating loss narrowed to $21.7 million; argenx reported 2024 net profit of $833.0 million, driven by a deferred tax benefit of $802 million, including a one-time $725 million recognition of previously unrecognized deferred tax assets.

Commercially/regulatorily, argenx received a positive CHMP recommendation for a VYVGART SC pre-filled syringe (PFS) for generalized myasthenia gravis (gMG), enabling an EU launch. FDA review of the PFS for gMG and CIDP remains on track with a PDUFA date of April 10, 2025; additional PFS decisions are expected in the EU (CIDP, H1 2025) and Japan/Canada (H2 2025). The company stated it surpassed 10,000 patients treated across three indications and plans 10 Phase 3 and 10 Phase 2 studies in 2025 across efgartigimod, empasiprubart, and ARGX-119, supporting pipeline expansion and future growth; 2025 R&D+SG&A guidance is ~ $2.5 billion.