argenx SE Q2 FY2025 earnings call

Vision and Growth

• Vision 2030 is the road map for long-term value creation, with VYVGART achieving 97% YOY growth across all approved indications and initiating multiple registrational trials in large market opportunities.

VYVGART Performance

• 15,000 patients globally are being treated with VYVGART, including 2,500 CIDP patients 1 year into launch, with growth across all indications, formulations, and regions.

Pipeline Progress

• 3 Phase III pipeline assets, including efgartigimod in myositis and Sjögren's, empasiprubart in MMN and CIDP, and ARGX-119 in CMS; ARGX-119 showed consistent functional improvements in a Phase I CMS study.

Immunology Innovation

• Rapidly advancing 4 new molecules in Phase I, including an IL-6 inhibitor, second FcRn blocker, and IgA targeting antibody; collaboration with Unnatural Products to expand AI-driven discovery capabilities.

In the second quarter of 2025, total operating income was $967 million, with $949 million in product net sales. Product net sales breakdown: $802 million in the U.S., $52 million in Japan, $83 million in rest of world markets (including Europe, Canada, and partner markets), and $12 million for product supply to Zai Lab in China. The U.S. contributed the largest share, over 80% of global product net sales. VYVGART achieved 97% year-over-year growth across all approved indications, and the prefilled syringe was driving new patient starts and prescriber demand.

Forward-Looking

• Expect data from 6 Phase III and 6 Phase II trials in the next 18 months to expand reach into new patient populations.
• Net revenue per MG and CIDP patient remains consistent despite higher gross to net, with PFS expected to help expand patient reach.

Risks

• Clinical trial risks: Intrinsic risks associated with the progress of ongoing clinical trials.
• Competitive risks: Potential increased competition in MG and CIDP markets.
• Regulatory and Safety: Uncertainties in regulatory timelines and safety monitoring (e.g., FAERS updates).

Q: How have cycles per year in MG evolved as additional chronic dosing data from AdDAP-NXT and neurologists' comfort with chronic FcRn administration are considered?

A: Karl noted net revenue per patient for MG and CIDP remains consistent despite higher gross to net, with variables like product mix, list price, etc. Karen mentioned continuing to guide to 5 cycles per year on average for an MG patient, with higher utilization and adherence due to Hytrulo and PFS convenience.

Q: Breakdown of PFS switches between Hytrulo and IV in MG?

A: Karen stated 50% of PFS patients were new to VYVGART, with the prefilled syringe driving market expansion rather than just switching existing markets.

Q: Expectations for increasing competition in MG and discontinuation rate?

A: Karen said Argenx is well-positioned to lead in MG with high MSE rate, rapid efficacy, and product presentations, welcoming innovation. Discontinuation rate is in line with expectations for chronic medicine.

Q: Gross margin outlook going forward?

A: Karl stated gross margin is expected to remain around 11%, with offsetting factors of decreasing cost of sales from CDMOs and increasing royalties from Hytrulo.