argenx SE Q4 FY2024 earnings call

• 2024 was a phenomenal year for argenx with expansion to over 10,000 patients globally across 3 approved indications and key clinical milestones achieved. • Commercially, VYVGART has shaped the gMG treatment landscape, with the prefilled syringe expected to drive growth in 2025. The launch of VYVGART Hytrulo in CIDP and plans to run an IVIg switch study and advance C2 inhibitors into a registrational study. • Disciplined approach to scaling with plans to advance 10 Phase III studies and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119. Leading in FcRn development with broad development plans across various indications. • Nominating 4 new molecules into Phase I development, including a second FcRn inhibitor, ARGX-213.

Product net sales were $737 million in Q4 2024 and $2.2 billion for the full year 2024. This represents 29% quarter-over-quarter growth and 98% growth compared with the same quarter from the prior year. Product revenue broke down by region to $649 million in the U.S., $27 million in Japan, $49 million in the rest of the world and $12 million in product supplied to Zai Lab in China. Gross margin was 90% with cost of sales at $73 million in Q4 and $227 million for the full year. For 2025, OpEx guidance is approximately $2.5 billion of combined R&D and SG&A expenses, a 25% increase year-over-year.

• 2025 OpEx guidance is approximately $2.5 billion of combined R&D and SG&A expenses, a 25% increase year-over-year. • Cash balance at year-end 2024 was $3.4 billion, increased by $200 million in 2024. • Anticipated to transition to profitability in 2025.

• Actual results may differ materially from forward-looking statements. • Uncertainty around FDA regulatory decisions for approvals of products like the prefilled syringe. • Competition in the autoimmune disease treatment space could impact market share.

Q: Tazeen Ahmad asked about pent-up demand for PFS, pricing, and potential magnitude of net price impacts.

A: Karen Massey said no pent-up demand expected, pricing to be provided at launch with framework of responsible and sustainable pricing. Karl Gubitz discussed net price impacts with self-administration leading to higher gross to net offset by increased patient volumes.

Q: Alex Thompson followed up on net price impacts and magnitude.

A: Karl Gubitz explained self-administration leads to higher gross to net with increased patient volumes offsetting it.

Q: Derek Archila asked about quarter-over-quarter growth cadence in MG and seasonal impacts.

A: Karen Massey said continued momentum in MG with Q1 seasonality an industry-wide phenomenon but underlying dynamics good.

Q: Yaron Werber asked about VBAs phasing out and CIDP trial assessments.

A: Karl Gubitz discussed VBAs phasing out with payer agreements, and Karen Massey said doctors use 12-week trials with simple assessments in CIDP.

Q: Victor Floch asked about 2025 news flow and self-administration importance ex U.S.

A: Tim Van Hauwermeiren and Karen Massey discussed news flow importance, self-administration benefit for patients and prescribers in other markets.

Q: Amy asked about myositis trial design and lupus nephritis data.

A: Tim Van Hauwermeiren said no changes to myositis trial protocol and discussed lupus nephritis data relevance.

Q: Rajan Sharma asked about biologics share progression in MG.

A: Karen Massey said market expansion with VYVGART used earlier and 60% of patients coming from orals.

Q: Suzanne van Voorthuizen asked about longer-term FcRn franchise and ARGX-213.

A: Tim Van Hauwermeiren discussed FcRn franchise optionality and ARGX-213's Phase I data plans.

Q: Vikram Purohit asked about auto-injector update.

A: Tim Van Hauwermeiren said auto-injector in background with 2027 aim.

Q: Andy Chen asked about CIDP launch metrics.

A: Karen Massey said early success in CIDP launch with 85% of patients switched from IVIg.

Q: Delma asked about seronegative and ocular MG trials.

A: Tim Van Hauwermeiren said no dosing or pricing difference from generalized MG.

Q: Matt Phipps asked about myositis trial patient enrollment.

A: Tim Van Hauwermeiren said need for minimum representation of subsets in Phase III trial.

Q: Gavin Clark-Gartner asked about PFS and VBAs in CIDP.

A: Karl Gubitz said VBAs would phase out for pharmacy benefit in CIDP.

Q: Samantha Semenkow asked about FDA granting self-administration for PFS.

A: Tim Van Hauwermeiren said strong data set submitted and confident in review process.

Q: Thomas Smith asked about LN trial baseline characteristics.

A: Tim Van Hauwermeiren praised Zai's partnership and discussed LN Phase II trial focus on mechanism of action.

Q: Leland Gershell asked about ARGX-119 proof-of-concept data.

A: Tim Van Hauwermeiren discussed ARGX-119's focus on CMS and related indications.

Q: Mehdi Goudarzi asked about ARGX-109.

A: Tim Van Hauwermeiren discussed ARGX-109's best-in-class IL-6 blocker properties and Phase I plans.

Q: Chris asked about PFS approval reach to patients.

A: Karen Massey said ready to launch PFS soon after PDUFA date.

Q: Douglas Tsao asked about ocular MG approval impact.

A: Karen Massey discussed potential impact on MG treatment paradigm and disease-modifying therapy view.

Q: Manos Mastorakis asked about competitors in CIDP and complement inhibitors.

A: Tim Van Hauwermeiren discussed CIDP response rates and empasiprubart's role in addressing unmet needs.