ARGX -119

February 27, 2025 — argenx SE reported full-year 2024 financial results and a Q4 business update centered on the VYVGART (efgartigimod) franchise (IV and SC/Hytrulo). Global product net sales were $736.97 million in Q4 2024 and $2.186 billion for full-year 2024 (vs. $374.35 million and $1.191 billion in 2023). Total operating income was $2.252 billion; full-year operating loss narrowed to $21.7 million. The company recorded a $747.9 million income tax benefit, including a one-time $725 million recognition of previously unrecognized deferred tax assets, contributing to full-year profit of $833.0 million.

Regulatory updates: argenx received a positive CHMP recommendation for a VYVGART SC pre-filled syringe (PFS) for generalized myasthenia gravis (gMG), enabling EU launch; FDA review for PFS in 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).

Pipeline/business: argenx plans to run 10 Phase 3 and 10 Phase 2 studies in 2025 across efgartigimod, empasiprubart, and ARGX-119, and guides 2025 combined R&D and SG&A expenses of approximately $2.5 billion, while expecting profitability in 2025.