CATALYST PHARMACEUTICALS, INC. Q3 FY2024 earnings call

Management Statement and Operational Highlights

• Financial Performance: Total revenues for Q3 2024 were $128.7 million, a 25.3% increase year-over-year. Full year 2024 total revenue guidance updated to between $475 million and $485 million.
• Clinical and Regulatory: SUMMIT study for AGAMREE underway to gather real-world data on clinical benefits like bone health, growth parameters, etc.
• Global Expansion: FIRDAPSE approved in Japan, expected to launch end of Q4 2024 with a $2.1 million milestone payment. AGAMREE in Canada in regulatory approval process. Focus on strategic partnerships in LatAm and APAC.
• Strategic Initiatives: Business development teams evaluating rare disease opportunities; inbound opportunities increasing, signaling market confidence in Catalyst's track record.

Segment Performance

• FIRDAPSE: Q3 2024 net product revenues were $79.3 million, a 19.7% increase year-over-year compared to $66.2 million in Q3 2023. Full year 2024 net revenue guidance updated to the $300 million to $310 million range.
• AGAMREE: Q3 2024 net product revenues were $15.0 million, reflecting continued strong commercial launch. Full year 2024 net revenue guidance updated to the $40 million to $45 million range.
• FYCOMPA: Q3 2024 net revenues were $32.1 million, a 11.9% decrease from Q3 2023 due to increased gross to net deductions. Remains on track to meet full year 2024 guidance.

Guidance

• Full year 2024 total revenue guidance updated to between $475 million and $485 million.
• FIRDAPSE full year 2024 net revenue guidance updated to the $300 million to $310 million range.
• AGAMREE full year 2024 net revenue guidance updated to the $40 million to $45 million range.
• FYCOMPA remains on track to meet full year 2024 guidance.

Risks

• Forward-looking statements involve risks, uncertainties, and assumptions; actual results may vary from expectations. Reference to SEC filings for detailed risk factors.

Question and Answer

Q: Now that FIRDAPSE will be commercially available in Japan this year, what are you looking for in a partner to commercialize in other regions such as China? And what's your growth adjustment for FYCOMPA and how should we expect that to trend going forward?

A: Steve Miller noted they continue to evaluate other territories for FIRDAPSE and will report when more is known. Michael Kalb explained FYCOMPA's gross to net adjustment is due to higher fees with distributors/government agencies, and the product's prescription performance is solid, with guidance still on track.

Q: Can you speak to what was the greatest source of uptake of FIRDAPSE? Was it idiopathic or small cell lung cancer patients? And how has the number of patients in your pipeline of identified candidates been? With regards to AGAMREE, with the improved near-term ramp, wondering if you have any thoughts on peak sales potential.

A: Jeffrey Del Carmen stated small cell lung cancer LEMS patients make up around 20%-25% of total patients, with efforts to increase testing for undiagnosed patients. Pipeline of identified candidates remains consistent at over 500. Regarding AGAMREE, EMFLAZA is a relatively good surrogate, but the SUMMIT study will help prove the product's advantages over time.

Q: When you think about FIRDAPSE, it seems like it's about finding new patients. With AGAMREE, it's a little bit different. So can you help us understand the synergies that you see in the commercial efforts? And a follow-up on the SUMMIT study.

A: Jeffrey Del Carmen explained FIRDAPSE focuses on educating for testing/diagnosis, with over 80% of prescribers being one-time, requiring broad coverage. AGAMREE targets a concentrated group of prescribers in DMD centers. Gary Ingenito noted the SUMMIT study is a 5-year study to gather long-term data on bone health, muscle strength, etc., with sites being trained for quality data collection.

Q: I had questions around AGAMREE versus FIRDAPSE's commercial strategy. First of all, when you think about FIRDAPSE, it seems like it's about finding new patients. With AGAMREE, it's a little bit different. So can you help us understand the synergies that you see in the commercial efforts? And then I had a follow-up on the SUMMIT study.

A: Jeffrey Del Carmen stated FIRDAPSE focuses on testing/diagnosis education, while AGAMREE targets a concentrated group of DMD prescribers. For the SUMMIT study, Gary Ingenito explained it's a 5-year study with site activation, central reading facilities, and training for quality data on bone health, muscle strength, etc.