Catalyst Pharmaceuticals Reports Record First Quarter 2025 Financial Results and Provides Business Update

Core Insights - Catalyst Pharmaceuticals reported record total revenues of $141.4 million for Q1 2025, reflecting a 43.6% year-over-year increase, driven by strong demand for its products [1][3][6] - The company reaffirmed its full-year 2025 revenue guidance, expecting total revenues to be between $545 million and $565 million [1][8] - Catalyst's balance sheet remains strong with cash and cash equivalents of $580.7 million and no debt as of March 31, 2025 [1][16] Financial Performance - Product revenue for Q1 2025 was $141.4 million, up from $98.4 million in Q1 2024, marking a 43.6% increase [3][24] - FIRDAPSE product revenue was $83.7 million, a 25.3% increase from $66.8 million in the previous year [3][9] - AGAMREE product revenue surged to $22.0 million from $1.2 million, representing a 1,777.5% increase [3][9] - GAAP net income for Q1 2025 was $56.7 million, a 143.8% increase compared to $23.3 million in Q1 2024 [3][14] - Non-GAAP net income for Q1 2025 was $86.6 million, an 85.2% increase from $46.8 million in the same period last year [3][15] Strategic Outlook - The company aims to establish AGAMREE as a cornerstone therapy in the Duchenne muscular dystrophy market and expand FIRDAPSE's clinical utility in Lambert-Eaton myasthenic syndrome [2] - Catalyst is actively evaluating opportunities to strengthen its portfolio and expand its market reach [2] - The company announced that Health Canada accepted the New Drug Submission for AGAMREE with Priority Review, potentially leading to approval by year-end 2025 [9] Operational Highlights - Research and development expenses for Q1 2025 were $3.9 million, up from $2.6 million in Q1 2024, with full-year expectations ranging between $15 million and $20 million [11] - Selling, general, and administrative expenses remained stable at $46.9 million for both Q1 2025 and Q1 2024, with a modest increase expected for the remainder of the year [12] - Operating income for Q1 2025 was $63.4 million, a significant increase from $27.1 million in Q1 2024 [13]