Catalyst Pharmaceuticals, Inc.

Catalyst reported 2025 total revenues of $589.0 million, up 19.8% from $491.7 million in 2024; fourth-quarter 2025 total revenues were $152.6 million, up 7.6% year over year. Net product revenue for 2025 was $588.8 million, up 20.3% year over year. GAAP net income was $214.3 million, or $1.68 per diluted share, versus $163.9 million, or $1.31 per diluted share, in 2024; non-GAAP net income was $346.2 million, or $2.72 per diluted share. FIRDAPSE full-year revenue was $358.4 million, up 17% for the year and 18.3% in Q4; AGAMREE full-year revenue was $117.1 million, up 154.3% year over year and 67.5% in Q4; FYCOMPA full-year revenue was $113.3 million. Cash and cash equivalents ended 2025 at $709.2 million, up from $517.6 million at year-end 2024. For 2026, the company guided total revenue to $615 million to $645 million, FIRDAPSE to $435 million to $450 million, AGAMREE to $140 million to $150 million, and FYCOMPA to $40 million to $45 million.

Rich Daly said 2025 was another “fantastic year” and framed the company as entering 2026 “from a position of strength” with significant momentum. He emphasized dual-market expansion for FIRDAPSE, deeper penetration for AGAMREE, and a disciplined business-development strategy focused on differentiated rare disease products with clear regulatory paths and near-term value. He also reiterated confidence in protecting FIRDAPSE IP and in expanding AGAMREE through data generation and possible label/lifecycle opportunities.

Mike Kalb detailed the financial results and guidance, including $589.0 million of 2025 revenue, $214.3 million of GAAP net income, and $709.2 million of cash and cash equivalents at year-end. He noted that 2026 FIRDAPSE guidance reflects a higher gross-to-net burden from the IRA impact on Medicare Part D, that AGAMREE’s growth continues to require meaningful royalty payments, and that FYCOMPA will remain meaningful even as generic competition erodes sales. He also said 2026 R&D is expected to be $17.5 million to $22.5 million and SG&A to increase slightly, while cash generation should support R&D, obligations, business development, and portfolio expansion.

Analysts focused on what drives 2026 growth for FIRDAPSE and AGAMREE, whether FIRDAPSE growth could remain above its historical range beyond 2026, and whether a business-development deal is likely this year. Management pointed to a greater than 600-patient identified LEMS pool, 21% growth in VGCC testing year over year, better lead quality via AI/machine learning and multiple data sources, and a 12% reduction in discontinuations after pharmacy interventions. On AGAMREE, they said adoption is broad across top DMD centers, reimbursement is above 85% and closer to 90%, the median age of new enrollees has fallen by about a year, and about 10% of patients start AGAMREE as their first steroid. On BD, management said they are evaluating opportunities thoughtfully and opportunistically but did not commit to a transaction in 2026.