CORAL GABLES, Fla., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced it ranked 304 on the 2025 Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in No ...

CORAL GABLES, Fla., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that Rich Daly, President and CEO, along with other members of Catalyst's management team, will participate in Citi’s 2025 Global Healthcare Conference in Miami on Tuesday, December 2, 202 ...

Summary of Catalyst Pharmaceuticals Conference Call Company Overview - Catalyst Pharmaceuticals (NasdaqCM: CPRX) is a buy-and-build organization focused on commercializing products in the rare disease space within the United States [1][5] - The company emphasizes a patient-centric approach, particularly through its robust patient support program [2][6] Core Business Model - Catalyst operates without traditional R&D, focusing instead on commercial risk and optimizing its product portfolio [5][6] - The company has a strong balance sheet with $689 million in cash and no funded debt, allowing for aggressive market actions [23] Product Portfolio - **Firdapse**: The only evidence-based treatment for Lambert-Eaton myasthenic syndrome (LEMS) in the U.S. with a significant addressable market estimated at $1 billion [10][12] - **Agamree**: A novel corticosteroid for Duchenne muscular dystrophy (DMD), with a market potential of $1 billion, recently approved in Canada [19][24] - **Fycompa**: An epilepsy drug that has outperformed expectations despite facing generic competition [7][20] Market Dynamics - LEMS has a limited patient population in the U.S., estimated between 3,600-5,400 patients, with a 50/50 split between cancer-associated and idiopathic cases [8][12] - The company has developed a patient identification system using data and AI to enhance diagnosis and treatment [9][10] Growth Strategies - Catalyst aims to optimize daily dosing for Firdapse and enhance patient adherence through pharmacy programs [10] - The company is actively working with group purchasing organizations to increase testing and treatment for cancer-associated LEMS [13][15] - For Agamree, the focus is on transitioning patients from standard corticosteroids, with a current transition rate of 85% [19] Financial Performance - Total net product revenue grew by 17.4%, with a year-over-year growth of 25.6% in the first nine months [21][22] - The company updated its revenue guidance to $565-$585 million for the year [22] Intellectual Property and Litigation - Catalyst has settled with three litigants in a patent case, with one remaining, extending commercial life until February 2035 [11][23] - The company is focused on protecting its intellectual property while pursuing synergistic assets through business development [24][25] Future Priorities - Accelerate education and promotion in the oncology space, particularly for cancer-associated LEMS [24] - Fully enroll the ongoing summit study for Agamree to assess its benefits compared to standard care [25]

Core Viewpoint - Catalyst Pharmaceutical (CPRX) is currently more attractive to value investors compared to Zoetis (ZTS) based on various valuation metrics and earnings outlook improvements [3][7]. Valuation Metrics - CPRX has a forward P/E ratio of 9.50, significantly lower than ZTS's forward P/E of 19.12 [5]. - The PEG ratio for CPRX is 0.80, indicating a more favorable valuation relative to its expected earnings growth, while ZTS has a PEG ratio of 2.11 [5]. - CPRX's P/B ratio stands at 3.03, compared to ZTS's P/B of 9.95, further highlighting the relative undervaluation of CPRX [6]. Earnings Outlook - CPRX has experienced stronger estimate revision activity, suggesting a more positive earnings outlook compared to ZTS [3][7]. - The Zacks Rank for CPRX is 2 (Buy), indicating a favorable investment position, while ZTS has a Zacks Rank of 4 (Sell) [3].

Catalyst Pharmaceutical (CPRX) closed the last trading session at $22.78, gaining 7.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $34.5 indicates a 51.5% upside potential.The average comprises eight short-term price targets ranging from a low of $32.00 to a high of $40.00, with a standard deviation of $2.67. While the lowest estimate indicates an increase of 40.5% from the cur ...

Core Insights - Catalyst Pharmaceuticals (CPRX) reported adjusted earnings of 68 cents per share for Q3 2025, exceeding the Zacks Consensus Estimate of 51 cents and up from 57 cents in the same quarter last year [1][6] - Total revenues reached $148.4 million, reflecting a 15% year-over-year growth and surpassing the Zacks Consensus Estimate of $136 million [1][6] Revenue Breakdown - Firdapse sales amounted to $92.2 million, a 16% increase year-over-year, driven by strong demand and increased prescription rates [3][6] - Agamree generated revenues of $32.4 million, more than doubling year-over-year, and also exceeding estimates [5][6] - Fycompa reported net product revenues of $23.8 million, down 26% year-over-year due to generic competition, but still beating estimates [8][6] Financial Guidance - Following strong Q3 results, Catalyst Pharmaceuticals raised its 2025 revenue guidance to a range of $565 million to $585 million, up from the previous range of $545 million to $565 million [10][12] - Specific revenue expectations for Firdapse are between $355 million and $360 million, Agamree between $105 million and $115 million, and Fycompa between $100 million and $110 million [12] Strategic Developments - The company acquired exclusive rights to manufacture and supply Agamree in 2023, which was approved by the FDA for treating Duchenne Muscular Dystrophy [4][6] - Catalyst Pharmaceuticals settled its Firdapse patent litigation with Lupin, blocking generic competition until February 2035, which strengthens the long-term revenue outlook for Firdapse [14][15]

Financial Data and Key Metrics Changes - Catalyst Pharmaceuticals reported total revenue of $148.4 million for Q3 2025, a 15.3% increase year over year from $128.7 million in Q3 2024 [4][21] - Net income before income taxes for Q3 2025 was $71.0 million, reflecting a 24.2% increase compared to $57.2 million in Q3 2024 [22] - GAAP net income for Q3 2025 was $52.8 million, or $0.42 per diluted share, up 20.3% from $43.9 million, or $0.35 per diluted share in Q3 2024 [22] - Non-GAAP net income for Q3 2025 was $86.1 million, or $0.68 per diluted share, compared to $71.1 million, or $0.57 per diluted share in Q3 2024 [23] - The company ended Q3 2025 with a cash position of $689.9 million and no debt, an increase from $517.6 million at the end of 2024 [5][26] Business Line Data and Key Metrics Changes - Firdapse generated revenue of $92.2 million in Q3 2025, a 16.2% increase year over year [6][14] - AGAMREE achieved net product revenue of $32.4 million in Q3 2025, a 115.2% increase from Q3 2024 [8][18] - FYCOMPA reported revenue of $23.8 million in Q3 2025, a decrease of 25.8% year over year due to generic competition [9][19] Market Data and Key Metrics Changes - The company raised its total revenue guidance for 2025 to between $565 million and $585 million, reflecting strong performance across its product lines [5][20] - Firdapse's full-year net product revenue guidance was maintained at between $355 million and $360 million [8][15] - AGAMREE's full-year net product revenue guidance was raised to between $105 million and $115 million [9][19] Company Strategy and Development Direction - Catalyst Pharmaceuticals is focused on expanding its market presence in both idiopathic and cancer-associated LEMS, with a strong emphasis on patient identification and education [7][16] - The company is actively pursuing business development opportunities and evaluating a broad range of potential acquisitions [12] - Catalyst Pathways, a personalized treatment support program, is a key differentiator in enhancing patient engagement and adherence [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term outlook, citing strong demand for rare disease therapies and operational excellence [4][5] - The company anticipates continued growth momentum into 2026, particularly for Firdapse and AGAMREE [8][17] - Management acknowledged the challenges posed by generic competition but remains optimistic about brand loyalty for FYCOMPA [19][33] Other Important Information - Catalyst announced a new share buyback program to repurchase up to $200 million of its common stock [5] - The company is committed to defending its intellectual property, with ongoing litigation against Hetero USA Incorporated set for trial in March 2026 [13][86] Q&A Session Summary Question: Insights on Firdapse's oncology efforts and Fycompa's brand loyalty - Management indicated that they are in the early stages of penetrating the oncology market for LEMS and will provide updates in future quarters [30][31] - Regarding Fycompa, management noted that brand loyalty remains strong, but they expect some revenue erosion as more generics enter the market [33][34] Question: Adoption of NCCN guidelines and Fycompa's stickiness - Management stated that the adoption of updated NCCN guidelines is more of a 2026 story, with ongoing efforts to educate oncology practices [41][42] - The stickiness of Fycompa is attributed to patient reluctance to switch medications, especially for anti-seizure treatments [38][39] Question: AGAMREE prescriber base and lifecycle management opportunities - Management reported strong adoption of AGAMREE across key treatment centers, with ongoing efforts to deepen prescribing [45][46] - Lifecycle management opportunities for AGAMREE are being evaluated, focusing on rare therapeutic areas [47][48] Question: Firdapse growth drivers and guidance rationale - Management highlighted that growth for Firdapse will come from both idiopathic and cancer-associated LEMS, with strong new patient enrollments [62][63] - The decision to maintain guidance rather than raise it reflects a cautious approach, anticipating potential seasonality in Q4 [67][68]

Core Insights - Catalyst Pharmaceutical (CPRX) reported $148.39 million in revenue for Q3 2025, marking a year-over-year increase of 15.3% and exceeding the Zacks Consensus Estimate by 8.77% [1] - The earnings per share (EPS) for the quarter was $0.68, up from $0.57 a year ago, representing a surprise of 33.33% over the consensus estimate of $0.51 [1] Revenue Breakdown - Product revenue from FIRDAPSE was $92.18 million, slightly above the average estimate of $91.78 million, reflecting a year-over-year increase of 16.2% [4] - Product revenue from FYCOMPA was reported at $23.8 million, significantly higher than the estimated $15.16 million, but this represents a decline of 25.8% compared to the previous year [4] - Product revenue from AGAMREE reached $32.38 million, surpassing the average estimate of $29.47 million, with a substantial year-over-year increase of 115.2% [4] - Total product revenue netted $148.37 million, exceeding the average estimate of $136.41 million, and showing a year-over-year growth of 17.4% [4] - License and other revenues were reported at $0.03 million, slightly above the average estimate of $0.02 million [4] Stock Performance - Catalyst's shares have returned +2.5% over the past month, outperforming the Zacks S&P 500 composite, which saw a +1% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [3]

Core Insights - Catalyst Pharmaceutical (CPRX) reported quarterly earnings of $0.68 per share, exceeding the Zacks Consensus Estimate of $0.51 per share, and showing an increase from $0.57 per share a year ago, resulting in an earnings surprise of +33.33% [1][2] - The company achieved revenues of $148.39 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 8.77% and up from $128.7 million year-over-year [2] - Catalyst has consistently outperformed consensus EPS and revenue estimates over the last four quarters [2] Earnings Outlook - The future performance of Catalyst's stock will largely depend on management's commentary during the earnings call and the trends in earnings estimate revisions [3][4] - The current consensus EPS estimate for the upcoming quarter is $0.48 on revenues of $137.08 million, and for the current fiscal year, it is $2.29 on revenues of $561.49 million [7] Industry Context - The Medical - Drugs industry, to which Catalyst belongs, is currently ranked in the top 40% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - The performance of Catalyst's stock may also be influenced by the overall industry outlook and trends [8] Competitor Insights - Guardian Pharmacy Services (GRDN), another company in the same industry, is expected to report quarterly earnings of $0.24 per share, reflecting a year-over-year increase of +112%, with revenues projected at $353.95 million, up 12.6% from the previous year [9][10]

Core Insights - Catalyst Pharmaceuticals reported Q3 2025 total revenues of $148.4 million, a 17.4% increase from Q3 2024, driven by growth in FIRDAPSE®, AGAMREE®, and continued demand for FYCOMPA® [1][5][9] - The company raised its full-year 2025 total revenue guidance to between $565 million and $585 million, reflecting better-than-expected performance [1][5] - A share repurchase program of up to $200 million was announced, indicating confidence in the company's long-term outlook [1][7] Financial Performance - Q3 2025 net product revenues reached $148.4 million, up from $126.4 million in Q3 2024, marking a 17.4% increase [5][9] - FIRDAPSE net product revenue for Q3 2025 was $92.2 million, a 16.2% increase compared to Q3 2024 [5][11] - AGAMREE net product revenue for Q3 2025 was $32.4 million, reflecting a 115.2% increase year-over-year [5][6] - FYCOMPA net product revenue for Q3 2025 was $23.8 million, a 25.8% decrease from Q3 2024 due to generic competition [5][6] Income and Expenses - GAAP net income for Q3 2025 was $52.8 million, a 20.3% increase from $43.9 million in Q3 2024 [11][24] - Non-GAAP net income for Q3 2025 was $86.1 million, up from $71.1 million in Q3 2024, representing a 21.2% increase [12][24] - Research and development expenses for Q3 2025 were $2.7 million, down from $3.3 million in Q3 2024 [10][21] - Selling, general and administrative expenses for Q3 2025 were $47.5 million, compared to $45.9 million in Q3 2024 [10][21] Cash Position - Cash and cash equivalents as of September 30, 2025, were $689.9 million, a 33.3% increase from $517.6 million at the end of 2024 [13][26] Strategic Developments - Catalyst announced the settlement of FIRDAPSE patent litigation with Lupin, allowing Lupin to market a generic version starting February 2035 [7] - The company is actively enrolling patients in the SUMMIT study for AGAMREE, aimed at evaluating its long-term clinical safety profile [5][7] - Catalyst has been recognized as one of the BioSpace 2026 Best Places to Work, ranking 13th among small companies in the U.S. [8]