argenx (ARGX) Guggenheim’s Inaugural Healthcare Innovation Conference summary

Strategic vision and milestones

• Achieved all Vision 2025 goals ahead of schedule and launched Vision 2030, focusing on innovation and pipeline expansion.

• Established leadership in myasthenia gravis (MG) with strong product differentiation and rapid patient response.

• Successful launch in CIDP with over 300 patients in the first quarter and robust early adoption.

• Near-term catalysts include myositis data by year-end, bullous pemphigoid data early next year, and a prefilled syringe PDUFA date in April.

• International expansion progressing, with 11 European markets now fully negotiated for pricing and reimbursement.

Commercial performance and market access

• Achieved 54% commercial and 65% government payer coverage for CIDP in the U.S., aiming for broad access by end of Q2 post-launch.

• CIDP launch dynamics differ from MG due to patient switching from IVIG and market access requirements.

• Vyvgart Hytrulo is a key growth driver, especially in international markets where subcutaneous administration is preferred.

• U.S. pricing for CIDP is $450,000 per patient per year, double that of MG at $225,000, reflecting higher utilization.

• European and international markets expected to reach up to two-thirds the size of the U.S. market over time.

Pipeline and R&D updates

• Myositis basket study data to be announced by year-end, with phase 3 enrollment ongoing for all three subsets.

• Bullous pemphigoid phase 2/3 data to be reviewed internally by year-end, with public disclosure likely at JPMorgan.

• Next-generation FcRn inhibitor targeting once-a-month dosing is in development, with IND expected in 2025.

• Ocular and seronegative MG studies are enrolling, each representing about 15% of the MG market.

• Empasiprubart (C2 blocker) moving directly into pivotal CIDP study, aiming to address patients not responsive to current therapy.