Catalyst Pharmaceuticals Inc

Latest Results (09.10.2025):

Catalyst Pharmaceuticals Inc. reported strong financial results for the third quarter of 2023, demonstrating significant growth in total net revenues and enhancing its financial guidance for the full year. The company's strategic initiatives and product developments have positively impacted its performance, setting a robust trajectory for future growth.

Revenue Growth

In the third quarter of 2023, Catalyst Pharmaceuticals achieved total net revenues of $102.7 million, marking a 79.4% increase year-over-year. FIRDAPSE® net product revenues reached $66.2 million, a 15.8% growth compared to the same period last year.

Non-GAAP Profitability

The company reported a non-GAAP net income of $55.9 million for the third quarter of 2023, reflecting a 95.2% increase from $28.6 million in the third quarter of 2022. Non-GAAP net income per share increased to $0.52 from $0.28 year-over-year.

Financial Guidance

Catalyst raised its full-year 2023 total revenue guidance to between $390 million and $395 million, an 82% to 84% increase compared to 2022. This adjustment underscores the company’s confidence in continued revenue growth amid improving macroeconomic and healthcare conditions.

Product Development and Approvals

The FDA accepted Catalyst’s sNDA seeking to increase the maximum daily dose of FIRDAPSE® to 100 mg for treating Lambert-Eaton myasthenic syndrome, with a PDUFA action date set for June 4, 2024. Additionally, the company achieved FDA approval for AGAMREE® (vamorolone) for Duchenne muscular dystrophy, with a commercial launch anticipated in the first quarter of 2024.

Leadership and Strategic Initiatives

Catalyst appointed Richard J. Daly as the new CEO effective January 1, 2024, and honored outgoing CEO Patrick J. McEnany with the 2023 Lifetime Achievement Award by BioFlorida. The company is also actively pursuing opportunities to expand its global footprint and enhance its neuroscience portfolio through strategic partnerships and acquisitions.