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]