Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Catalyst Pharmaceuticals Inc (CPRX, Financial) reported a 25.3% year-over-year increase in total revenues for Q3 2024, reaching $128.7 million.
- The company updated its full-year 2024 total revenue guidance to between $475 million and $485 million, reflecting strong performance.
- Ferds continues to deliver outstanding net revenues and growth, with a 19.7% increase year-over-year.
- A gaming's market success led to an increase in full-year 2024 net revenue projections to between $40 million and $45 million.
- Catalyst Pharmaceuticals Inc (CPRX) is making strides in global expansion, with recent regulatory approval in Japan and ongoing efforts in Canada.
Negative Points
- Capa experienced a 12% decrease in net revenues compared to Q3 2023 due to adjustments in gross to net.
- Increased gross to net deductions for Pampa were driven by higher costs tied to arrangements with distributors and government agencies.
- The company faces competitive challenges in the market, particularly with the launch of a gaming into an active competitive environment.
- Research and development expenses are expected to be significantly lower than previously provided guidance, indicating potential delays in R&D initiatives.
- The effective tax rate is likely to fluctuate in future periods, affecting financial predictability.
Q & A Highlights
Q: Now that FAPS will be commercially available in Japan this year, what are you looking for in a partner to commercialize in other regions such as China? Also, what drove the gross-to-net adjustment for BIPA, and how should we expect that to trend going forward?
A: We expect FAPS to be launched in Japan at the end of the year and are evaluating other territories globally. Regarding China, we continue to explore opportunities and will update as they become clear. For BIPA, fees reflected in gross-to-net are higher with distributors and government agencies compared to last year. This is likely to remain consistent as long as we have exclusivity.
Q: Can you speak to the greatest source of uptake for FAPS? Was it idiopathic or small cell lung cancer patients? Also, with the improved near-term ramp for a GY, what are your thoughts on its peak sales potential?
A: Small cell lung cancer LEMS patients make up about 20-25% of our total patients. We aim to help the 90% of undiagnosed small cell lung cancer LEMS patients get tested. Our pipeline of over 500 patients has been consistent. For a GY, we believe it has a better product profile than Emflaza, and while Emflaza is a good surrogate, we think a GY has the potential to exceed it.
Q: Can you help us understand the synergies in commercial efforts between a GY and FAPS?
A: FAPS focuses on educating healthcare providers for testing and diagnosis, with over 80% of prescribers being one-time prescribers. For a GY, the focus is on educating about its benefits for DMD, with 250 prescribers making up 90% of steroid prescriptions. The approach is more targeted for a GY due to the concentrated prescriber base.
Q: Regarding the summit study, what do you anticipate over the next year in terms of patient numbers and target product profile?
A: The study is a five-year study focusing on long-term data for DMD. We are in the site activation stage, ensuring high-quality data collection. We aim to demonstrate positive effects on bone health, reduced fracture rates, and limited weight increase, alongside preserving muscle strength and mobility.
Q: Are you seeing any trends in the durability of therapy for a GY, and how stable is your patient mix?
A: We are seeing strong durability with a 15% discontinuation rate, which is stable and within expectations. The patient mix for transitions from prednisone and Emflaza is stable, and we expect this trend to continue, showing positive transitions across both corticosteroid segments.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
