Catalyst Pharmaceuticals (NasdaqCM:CPRX) FY Conference Transcript

Summary of Catalyst Pharmaceuticals FY Conference Call Company Overview - Catalyst Pharmaceuticals operates in the Central Nervous System (CNS) space, focusing on therapies for rare diseases, particularly Lambert-Eaton Myasthenic Syndrome (LEMS) and Duchenne Muscular Dystrophy (DMD) [3][4] Key Product Insights FIRDAPSE - FIRDAPSE is a successful therapy for LEMS, with over six years on the market and a strong performance record, achieving 15 consecutive quarters of 15% or more growth until impacted by a cyberattack [5] - In the first half of 2025, FIRDAPSE sales grew by 17% compared to the first half of 2024, with a current addressable market of approximately $1.2 billion [5] - The company has split its brand team to focus on idiopathic and oncology-related markets, aiming to sustain growth [6] - The NCCN guidelines inclusion is expected to enhance market penetration, with a focus on integrating these guidelines into care pathways of major oncology practices [8][10] AGAMREE - AGAMREE is a differentiated steroid for DMD, with a significant unmet medical need as only 7% of diagnosed patients are currently on steroids despite 95% having used them at some point [23] - The product has penetrated 93% of the 100 centers of excellence in the U.S., with a dedicated sales force to enhance growth [24][25] - The company is addressing competition from gene therapies and has a strong share of voice in the steroid market [26] - AGAMREE's side effect profile is reported to be superior, with benefits in bone health and reduced anxiety compared to other steroids [32] Market Dynamics - The company is actively identifying patients through AI and machine learning, focusing on misdiagnosed cases of myasthenia gravis to drive growth in the idiopathic market [11][12] - The average physician sees very few LEMS patients, making patient prospecting essential [13] - There are approximately 900 LEMS patients diagnosed annually with small cell lung cancer, presenting a significant opportunity for the company [14] Intellectual Property and Litigation - Catalyst Pharmaceuticals has settled three out of four lawsuits related to its intellectual property, with ongoing litigation against Hetero [18] - The settlements extend the product's market exclusivity, potentially allowing for an additional 10 years of growth [19] Business Development Strategy - The company is focused on acquiring differentiated, profitable products and emphasizes the importance of cultural fit in partnerships [38][39] - Current market conditions are seen as favorable for finding new assets, with 80-90% of opportunities being inbound due to the company's success [39] Future Outlook - Catalyst Pharmaceuticals aims to explore opportunities within the CNS space, particularly in movement disorders, while keeping peak year sales under $500 million to avoid competition with larger players [40] - The company is therapeutic agnostic, believing its existing infrastructure can support various therapeutic areas [41] Conclusion - Catalyst Pharmaceuticals expresses optimism about future growth opportunities and appreciates the support from stakeholders [42]