argenx SE Q3 FY2024 earnings call

Key Points

• Commercial expansion: 11th consecutive quarter of growth, with CIDP launch starting strong. VYVGART Hytrulo has reached over 300 CIDP patients, correlating to revenue approaching that of the first MG quarter.
• AAN presence: Presented new clinical trial and real-world data, including VYVGART driving rapid, deep, and sustained responses with multiyear data on durable efficacy. Showcased three clinical programs from the pipeline.
• Pipeline updates: Myositis go/no-go decision before year-end for efgartigimod in three subsets; discontinued efgartigimod development in MN as interim data lacked efficacy signal. Continued investment in innovation across pipeline programs in MG, CIDP, MMN, CMS, and ALS.
• MG performance: Drove majority of growth, with Hytrulo attracting new patients and prescribers, over 60% of new patients coming from oral, and over half achieving MSE.

In the third quarter of 2024, total product net sales were $573 million, representing 20% quarter-over-quarter growth and 74% growth compared to the corresponding prior year quarter. Product revenue broke down by region as follows: $492 million in the U.S., $24 million in Japan, $46 million in the rest of the world, and $11 million for product supply to Zai Lab in China. The gross margin was 90% in Q3, consistent with previous quarters.

Guidance

• Cash balance at quarter-end was $3.4 billion, increased by $272 million in the quarter. Combined SG&A and R&D spend guidance of $2 billion remains unchanged. Not providing revenue or patient number guidance for CIDP launch, but will continue to monitor relevant KPIs.
• For the pipeline, expect detailed clinical calendar for 2025 to be announced in January, with multiple Phase 3 trials and ongoing Phase 2 work.

Risks

• Market dynamics: Unique market dynamics for CIDP launch, including payer policies and competition. Uncertainties in how utilization trends will play out over time.
• Clinical trial outcomes: Risks associated with clinical trials, such as not seeing sufficient efficacy signals in studies like the myositis basket study or potential challenges in other pipeline programs.
• Payer access: Delays in payer policies coming into place, which can affect patient access to treatment.

Q: How has the CIDP launch trajectory been and how does it figure into guidance?

A: Karen Massey stated CIDP patient starts have been relatively linear, payer policies are on track, and no revenue guidance is provided, but will monitor KPIs like response rates.

Q: What's the update on payer policies and patient treatment time for CIDP?

A: Karen Massey mentioned payer policies take two quarters to come in, currently 54% of commercial lives covered, and patients are moving smoothly from prescription to therapy.

Q: Has the CIDP launch impacted the view on the overall opportunity size?

A: Tim Van Hauwermeiren and Karen Massey stated the addressable market for CIDP is still 12,000 patients, and the 50,000 patient goal by 2030 includes more than MG and CIDP.

Q: Thoughts on dosing frequency and price for CIDP?

A: Karl Gubitz mentioned $450,000 is the launch price, utilization and real-world dosing will determine actual revenue, and it's too early to provide more details.

Q: Update on pipeline clinical trials and launches?

A: Karen Massey discussed the April PDUFA date for VYVGART Hytrulo PFS and ongoing filings for ex-U.S. launch, with detailed clinical calendar for 2025 to be announced in January.