Core Viewpoint - Catalyst Pharmaceuticals and SERB have reached a settlement with Lupin regarding the patent litigation over FIRDAPSE, allowing Lupin to market a generic version starting February 25, 2035, pending FDA approval [1][2]. Group 1: Settlement Agreement Details - The settlement agreement resolves ongoing patent litigation between Catalyst/SERB and Lupin concerning FIRDAPSE [2]. - Lupin is prohibited from marketing its generic version of FIRDAPSE in the U.S. before February 25, 2035, unless specific circumstances arise [2]. - The agreement includes the termination of all ongoing patent litigation related to FIRDAPSE patents in the U.S. District Court for the District of New Jersey [2]. Group 2: Company Background - Catalyst Pharmaceuticals is focused on developing and commercializing treatments for rare diseases and has a strong commitment to patient care [4]. - The company has been recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies [4].

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 reached $146.6 million, a 19.4% increase year over year, while total revenue for 2025 grew 30.2% to $288 million [5][29] - The company ended Q2 2025 with a cash position of $652.8 million, reinforcing its ability to invest strategically for long-term growth [5][29] - GAAP net income for Q2 2025 was $52.1 million, or $0.41 per diluted share, reflecting a 27.7% increase year over year [30] Business Line Data and Key Metrics Changes - Firdapse generated net product revenue of $84.8 million in Q2 2025, a 9.7% increase year over year, with year-to-date revenue of $168.6 million, representing a 16.9% increase over 2024 [6][29] - GammaRy achieved net product revenue of $27.4 million in Q2 2025, a 213% increase year over year, with first half revenues reaching $49.4 million, up 398% from the prior year [10][29] - Fycompa reported revenue of $34.3 million in Q2 2025, a 6% decrease year over year, with full year guidance remaining unchanged at $90 million to $95 million [11][29] Market Data and Key Metrics Changes - The company is focusing on expanding its reach in the oncology market, where it believes potentially 90% of cancer-associated LEMS patients remain undiagnosed, representing a significant growth opportunity [9][24] - The updated NCCN guidelines for small cell lung cancer, published on July 25, now include VGCC antibody testing and recommend amifampridine for treatment, which is expected to enhance market access [22] Company Strategy and Development Direction - The company is advancing a focused expansion strategy for Firdapse, centered on educating healthcare providers and improving diagnostic access [9][21] - The company remains committed to disciplined business development, actively evaluating opportunities that align with its long-term growth strategy [16][98] - The leadership changes, including the appointment of a new Chief Medical Officer, are aimed at ensuring scientific rigor and operational excellence [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full year 2025 revenue guidance of $545 million to $565 million, supported by strong leading indicators [6][35] - The company anticipates sustained growth driven by the strong performance of its commercial portfolio and the successful execution of its strategic initiatives [35] Other Important Information - The company is awaiting a trial date in ongoing patent litigation for Firdapse, expected in Q4 2025 or Q1 2026 [17] - The company published its 2024 ESG report, underscoring its commitment to sustainable growth and responsible innovation [18] Q&A Session Summary Question: Can you speak more about your strategy for educating oncologists on the LEMS opportunity? - The company is focused on increasing frictionless testing for patients and has implemented digital marketing and educational initiatives to engage oncologists [38][41] Question: What impact are you seeing on Firdapse and GammaRy uptake following the increase in sales force size? - Early indicators show increased engagements and deeper relationships with healthcare providers, with strong performance in enrollments for both products [49][51] Question: How do you view the potential for PTCT's Translarna FDA approval for DMD treatment? - The company believes that GammaRy will continue to retain market share as it is viewed as a differentiated treatment option for DMD [93][95] Question: What is your current stance on near-term strategic initiatives to offset Fycompa's loss of exclusivity? - The company is actively assessing multiple opportunities for business development and lifecycle management to offset potential revenue loss from Fycompa [96][98]

Financial Data and Key Metrics Changes - Catalyst Pharmaceuticals reported total revenue of $146.6 million for Q2 2025, a 19.4% increase year over year, and total revenue for 2025 reached $288 million, reflecting a 30.2% growth [5][28] - The company ended Q2 2025 with a cash position of $652.8 million, indicating strong financial health and capacity for strategic investments [5][28] - GAAP net income for Q2 2025 was $52.1 million, or $0.41 per diluted share, representing a 27.7% increase year over year [29] Business Line Data and Key Metrics Changes - Firdapse generated net product revenue of $84.8 million in Q2 2025, a growth of $7.5 million compared to Q2 2024, with year-to-date revenue of $168.6 million, a 16.9% increase over the previous year [6][28] - GammaRy achieved net product revenue of $27.4 million in Q2 2025, a 213% increase year over year, with first half revenues reaching $49.4 million, up 398% from the prior year [10][28] - Fycompa reported revenue of $34.3 million in Q2 2025, reflecting a 6% decrease year over year, with full year guidance remaining unchanged at $90 million to $95 million [11][28] Market Data and Key Metrics Changes - The company noted that approximately 90% of cancer-associated LEMS patients remain undiagnosed, presenting a significant opportunity for market expansion [9][23] - Prescription approval rates for Firdapse remained above 90%, indicating strong patient adherence and a solid foundation for sustained performance [20] Company Strategy and Development Direction - Catalyst Pharmaceuticals is focused on expanding Firdapse's market presence in oncology, supported by updated NCCN guidelines that recommend its use for cancer patients with LEMS [9][22] - The company is actively pursuing a three-step strategy to enhance diagnostic access and improve patient outcomes, which includes frictionless testing, educational initiatives, and partnerships with oncology practices [21][23] - The leadership team has been strengthened with the addition of new executives, enhancing the company's strategic capabilities [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full year 2025 revenue guidance of $545 million to $565 million, supported by strong leading indicators and a balanced commercial portfolio [6][33] - The company remains committed to disciplined financial management and strategic growth, with a focus on long-term value creation [16][33] Other Important Information - Catalyst Pharmaceuticals is awaiting a trial date for ongoing patent litigation related to Firdapse, with expectations for clarity following a scheduled Markman hearing [16] - The company published its 2024 ESG report, emphasizing its commitment to sustainable growth and responsible innovation [17] Q&A Session Summary Question: Can you speak more about your strategy for educating oncologists on the LEMS opportunity? - The company is focused on increasing frictionless testing for patients and enhancing education through digital marketing, congresses, and publications. Success will be tracked through increased VGCC antibody testing and a growing mix of cancer-associated LEMS patients [36][39][41] Question: What impact are you seeing on Firdapse and GammaRy uptake following the increase in sales force size? - Early indicators show increased engagements and deeper relationships with healthcare providers, with strong performance in enrollments and a solid pipeline for both products [47][50][51] Question: How do you view the potential for PTCT's Translarna FDA approval for DMD treatment? - The company believes that GammaRy will continue to retain market share as it is viewed as a differentiated steroid treatment for DMD, unaffected by Translarna's approval [88][90] Question: What is your current stance on near-term strategic initiatives to offset Fycompa's loss of exclusivity? - The company is actively assessing multiple opportunities for business development and lifecycle management to offset potential revenue loss from Fycompa [92][93]

Core Insights - Catalyst Pharmaceuticals reported record financial results for Q2 and the first half of 2025, with total revenues of $146.6 million for Q2, reflecting a 19.4% year-over-year increase, and $288.0 million for the first half, a 30.2% increase over the prior year [1][6][8] - The company reaffirmed its full-year 2025 revenue guidance of $545 million to $565 million, indicating broad-based growth and sustained demand across its product portfolio [1][6] Financial Performance - Q2 2025 net product revenue reached $146.5 million, a 19.5% increase year-over-year, driven by strong demand across the portfolio [4][8] - FIRDAPSE net product revenue for Q2 2025 was $84.8 million, up 9.7% year-over-year, while the first half revenue was $168.6 million, a 16.9% increase [1][8] - AGAMREE achieved remarkable growth with Q2 2025 net product revenue of $27.4 million, a 212.9% increase year-over-year, and $49.4 million for the first half, a 398.0% increase [1][8] - FYCOMPA's Q2 2025 net product revenue was $34.3 million, reflecting a slight decrease of 6.0% year-over-year due to generic competition [1][8] Profitability Metrics - GAAP net income for Q2 2025 was $52.1 million, representing a 27.7% increase from $40.8 million in Q2 2024 [15] - Non-GAAP net income for Q2 2025 was $86.4 million, a 24.0% increase from $69.6 million in the same quarter of the previous year [16] - Operating income for Q2 2025 was $66.3 million, up 22.2% from $54.2 million in Q2 2024 [14] Cash Position - As of June 30, 2025, the company reported a strong cash position of $652.8 million with no funded debt [1][18] Strategic Developments - The National Comprehensive Cancer Network® updated guidelines to include VGCC antibody testing for cancer-associated Lambert-Eaton myasthenic syndrome (LEMS) and the use of FIRDAPSE in treatment, which is expected to enhance clinical awareness and diagnostic rates [8] - The company appointed Daniel J. Curran, MD, to its Board of Directors on August 4, 2025, and published its 2024 ESG Report on June 30, 2025 [8][17]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [Mark One] ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2025 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File No. 001-33057 CATALYST PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) | Delaware | 76-0837053 | | --- | --- | | (State or other juri ...

Core Insights - Catalyst Pharmaceuticals announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Small Cell Lung Cancer (SCLC) now include new recommendations regarding Lambert Eaton myasthenic syndrome (LEMS) and the use of amifampridine (FIRDAPSE) [1][2] Group 1: NCCN Guidelines Update - The updated NCCN guidelines for SCLC now specify symptoms of LEMS, including proximal muscle weakness and autonomic dysfunction, and recommend diagnosis through neurological evaluation and testing for PQ- and N-type VGCC antibodies [2] - Amifampridine is recommended as a treatment option in consultation with neurology under the principles of supportive care [2] Group 2: LEMS and SCLC Connection - Approximately 50% of LEMS cases are associated with an underlying malignancy, most commonly SCLC, with literature indicating that LEMS is observed in 3% of SCLC patients [3] - An internal healthcare database analysis suggests that potentially 90% of LEMS patients with SCLC remain undiagnosed, which may lead to untreated symptoms during SCLC treatment [3] Group 3: Importance of Early Diagnosis - Early diagnosis of LEMS in SCLC is critical for improving patient outcomes, as effective treatment of LEMS symptoms can enhance the overall management of SCLC [4] - Accurate identification through VGCC antibody testing and comprehensive neurological evaluation is emphasized as essential for patient care [4] Group 4: Company Overview - Catalyst Pharmaceuticals is focused on improving the lives of patients with rare diseases and has a proven track record in bringing life-changing treatments to market [5] - The company prioritizes accessibility and support services to ensure patients receive necessary care, maintaining a strong U.S. presence while exploring global expansion opportunities [5] - Catalyst was recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies [5]

Core Insights - Catalyst Pharmaceuticals, Inc. has appointed Dr. Daniel Curran to its Board of Directors, bringing over 25 years of pharmaceutical experience [1][2] - Dr. Curran's expertise includes strategy, business development, and rare disease knowledge, which will support Catalyst's growth strategy [3][4] - The company has a strong foundation in delivering innovative therapies for rare diseases and aims to expand its global presence [7] Company Overview - Catalyst Pharmaceuticals is focused on improving the lives of patients with rare diseases through innovative therapies [7] - The company has been recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list [7] - Catalyst emphasizes patient care and accessibility, providing comprehensive support services to ensure patients receive necessary treatments [7] Leadership Background - Dr. Curran has held significant roles at Takeda Pharmaceutical Company, including Senior Vice President and Head of the Rare Genetics and Hematology Therapeutic Area Unit [3][4] - He has also served in leadership positions at Millennium Pharmaceuticals and DuPont Merck Pharmaceuticals [4][5] - Dr. Curran holds an M.D. from the University of Pennsylvania, an M.B.A. from The Wharton School, and a B.S. in chemistry from King's College [6]

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Core Viewpoint - Catalyst Pharmaceuticals, Inc. is set to release its second quarter 2025 financial results on August 6, 2025, followed by a conference call and webcast on August 7, 2025, to discuss these results and provide a business update [1][2]. Company Overview - Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing novel medicines for patients with rare and difficult-to-treat diseases [1][4]. - The company has a proven track record of bringing life-changing treatments to market and emphasizes patient care and accessibility through a comprehensive suite of support services [4]. - Catalyst is headquartered in Coral Gables, Florida, and has been recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies [4]. Conference Call & Webcast Details - The conference call and webcast will take place on August 7, 2025, at 8:30 AM ET [2][3]. - Dial-in numbers for the call include (877) 407-8912 for US/Canada and (201) 689-8059 for international participants [3]. - The webcast will be accessible on the company's website and will be available for replay for at least 30 days following the event [3].