Catalyst Pharmaceuticals Reports Record Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Core Insights - Catalyst Pharmaceuticals reported total revenues of $491.7 million for the full year 2024, reflecting a year-over-year growth of 23.5% driven by strong commercial performance [1][11][12] - The company expects total revenues for 2025 to be between $545 million and $565 million, indicating confidence in continued growth momentum [1][22] Financial Performance - Full year 2024 product revenue, net was $489.3 million, a 23.4% increase from $396.5 million in 2023 [3][12] - Q4 2024 net product revenue was $141.8 million, representing a 28.3% increase compared to Q4 2023 [1][11] - GAAP net income for 2024 was $163.9 million, a significant increase of 129.5% from $71.4 million in 2023 [3][17] - Non-GAAP net income for 2024 was $276.3 million, up 95.1% from $141.6 million in 2023 [3][18] Product Performance - FIRDAPSE product revenue for 2024 was $306.0 million, an 18.4% increase year-over-year [1][9] - AGAMREE product revenue for 2024 was $46.0 million, reflecting a successful commercial launch [1][9] - FYCOMPA product revenue for 2024 was $137.3 million, showing a slight decline of 0.6% compared to 2023 [3][9] Strategic Developments - Catalyst successfully launched AGAMREE in the U.S. on March 13, 2024, for the treatment of Duchenne muscular dystrophy [9][10] - The company received FDA approval for an increased maximum daily dose of FIRDAPSE to 100 mg on May 30, 2024 [9] - Catalyst entered into a settlement agreement with Teva Pharmaceuticals regarding FIRDAPSE patent litigation, preventing Teva from marketing a generic version until February 25, 2035 [9][10] Future Outlook - For 2025, FIRDAPSE's product revenue is expected to range between $355 million and $360 million, while AGAMREE's revenue is anticipated to be between $100 million and $110 million [22][24] - FYCOMPA's product revenue is forecasted to be between $90 million and $95 million, influenced by the anticipated loss of patent exclusivity [25] - Research and development expenses for 2025 are expected to be between $15.0 million and $20.0 million, depending on ongoing studies and potential acquisitions [27]