argenx Highlights 2025 Strategic Priorities

Financial Performance - Reported preliminary full-year 2024 global product net sales of $2.2 billion, including$737 million in Q4 sales [1] - As of December 31, 2024, the company had approximately 3.4 billion in cash, cash equivalents, and current financial assets [16] - Expected combined R&D and SG&A expenses in 2025 to be approximately 2.5 billion [18] Strategic Priorities for 2025 - Expand the global VYVGART opportunity by reaching more patients across MG, CIDP, and ITP through additional regulatory approvals and evidence generation [3] - Launch VYVGART SC as a pre-filled syringe to innovate the patient experience and move earlier in the MG and CIDP treatment paradigms [3] - Execute 10 registrational and 10 proof-of-concept studies to fuel pipeline growth across efgartigimod, empasiprubart, and ARGX-119 [3][4] - Advance four new molecules into Phase 1 development, expanding the next wave of innovation [3] Pipeline Development - Efgartigimod is being evaluated in over 15 severe autoimmune diseases, with development discontinued in bullous pemphigoid (BP) based on Phase 2 BALLAD study results [5][9] - Empasiprubart is being evaluated in registrational studies for MMN and CIDP, and proof-of-concept studies in DGF and DM [6][19] - ARGX-119 is being evaluated in CMS, ALS, and SMA, with SMA nominated as a third indication [14][19] - Four new pipeline molecules (ARGX-213, ARGX-121, ARGX-109, ARGX-220) nominated, with IND applications to be filed in 2025 [15] Regulatory and Clinical Milestones - FDA PDUFA target action date for pre-filled syringe approval set for April 10, 2025 [1][13] - Regulatory decisions on VYVGART for gMG expected in Israel (SC), South Korea (IV), and Kuwait (IV) in H1 2025 [13] - Topline results expected for multiple studies, including ALKIVIA (H2 2026), UplighTED (H2 2026), UNITY (2027), and Phase 4 switch study in CIDP [5][13] - Auto-injector development underway with a planned launch in 2027 [13] Vision 2030 - Aim to treat 50,000 patients globally with its medicines by 2030 [11] - Secure 10 labeled indications across all approved medicines by 2030 [11] - Advance five pipeline candidates into Phase 3 development by 2030 [11] Innovation and Investment - Continued investment in the Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth [8][15] - Focus on first-in-class, antibody-based medicines with pipeline-in-a-product potential [8] - Innovation playbook applied to bring transformational outcomes to more patients by unleashing the next wave of autoimmune indications and therapies [7]