Summary of Catalyst Pharmaceuticals (CPRX) Conference Call Company Overview - Catalyst Pharmaceuticals is a commercial stage company focused on rare orphan diseases, utilizing a license and acquisition model for growth [1] Key Financial Performance - The company reported record sales and earnings for Q1 2025, building on a successful 2024 [3] - Firdapse, a treatment for Lambert-Eaton Myasthenic Syndrome (LEMS), grew by 25% compared to Q1 2024, exceeding the forecasted growth of 15-20% [4][5] - GammaRay, a treatment for Duchenne muscular dystrophy, generated $22 million in its first full quarter on the market [4] - Fycompa, an epilepsy product, showed strong performance despite potential generic competition [4][7] Market Opportunities and Strategies - The company sees a significant market opportunity for Firdapse, estimating it could reach a billion-dollar market with continued growth [9][14] - There is a focus on two distinct markets for Firdapse: idiopathic and cancer-related LEMS, with strategies tailored to each [10][12] - The company is implementing frictionless testing to accelerate patient identification and treatment in the oncology space [13] - The average time from first symptom to treatment with Firdapse is approximately six years, indicating a need for increased patient education [11] Patient Identification and Treatment Dynamics - Approximately 500 patients have been identified who may have LEMS, with 75% believed to be idiopathic [29] - The company is working closely with physicians to improve patient identification and treatment initiation [30] - The persistence rate for idiopathic patients on Firdapse is around 90%, indicating strong long-term treatment adherence [21] Litigation and Market Position - The company is currently involved in litigation regarding Firdapse, with a trial expected to occur by early 2026 [32] - Settlements have been reached with two litigants, and the company is optimistic about resolving remaining cases [34] Competitive Landscape and Product Launches - GammaRay's launch has been successful, sourcing patients from both Emflaza and prednisone, with a retention rate of 85% [42] - The company is not currently facing significant generic competition for GammaRay, which is a positive indicator for market performance [42] Financial Outlook and Growth Projections - The royalty rate on Firdapse is set to decrease significantly from 17% in 2025 to 6% by 2027, which will positively impact the company's financials [57][59] - The company anticipates continued growth, although a slowdown may occur as the base increases [25][26] Macro Environment and Acquisition Strategy - Catalyst Pharmaceuticals is well-positioned to acquire new assets, with $600 million in cash and no debt, making it a strong player in a consolidating biotech environment [70] - The company is actively looking for acquisition opportunities and believes it can effectively bring new products to market [72] Regulatory and Pricing Considerations - The company has a higher exposure to Medicaid for GammaRay (55%) compared to Medicare for Firdapse (40%) [61] - Pricing dynamics in international markets are complex, with significant differences in pricing across countries [62][64] Conclusion - Catalyst Pharmaceuticals is experiencing strong growth driven by its key products, Firdapse and GammaRay, with a clear strategy for market expansion and patient engagement. The company is also strategically positioned for potential acquisitions in a challenging macroeconomic environment.

Core Insights - Catalyst Pharmaceuticals (CPRX) reported adjusted earnings of 68 cents per share for Q1 2025, exceeding the Zacks Consensus Estimate of 53 cents and up from 38 cents in the same quarter last year [1] - Total revenues reached $141.4 million, reflecting a 44% year-over-year growth and surpassing the Zacks Consensus Estimate of $130 million [1] Revenue Breakdown - The primary revenue sources included Firdapse, Fycompa, and Agamree, with Firdapse generating $83.7 million in sales, a 25% increase year-over-year, exceeding estimates [2] - Fycompa, acquired in 2023, contributed $35.6 million in net product revenues, marking a 17% year-over-year growth and surpassing estimates [3] - Agamree generated $22 million in revenues, significantly up year-over-year, also beating estimates [7] Financial Position - As of March 31, 2025, Catalyst Pharmaceuticals had cash, cash equivalents, and investments totaling $580.7 million, an increase from $517.6 million at the end of 2024 [8] 2025 Financial Guidance - The company expects total revenues between $545 million and $565 million for 2025, driven by continued growth in product revenues from Firdapse and Agamree [9] - Firdapse revenues are projected between $355 million and $360 million, while Agamree revenues are anticipated to be between $100 million and $110 million [9] - Fycompa revenues are expected to be between $90 million and $95 million, reflecting anticipated market exclusivity loss [10] Research and Development - R&D expenses are projected to be between $15 million and $20 million in 2025, influenced by investments in the SUMMIT study for Agamree [11] - SG&A expenses are expected to rise "modestly" in 2025 [11]

Financial Data and Key Metrics Changes - Total net revenues increased by 43.6% year over year to $141,400,000, with significant contributions from all products [5][25]. - Net income before income taxes for Q1 2025 was $71,300,000, a 145% increase year over year compared to $29,100,000 in Q1 2024 [27]. - GAAP net income for Q1 2025 was $56,700,000 or $0.47 per basic share, up 144% from $23,300,000 or $0.20 per basic share in Q1 2024 [27][29]. - Non-GAAP net income for Q1 2025 was $86,600,000 or $0.71 per basic share, compared to $46,800,000 or $0.40 per basic share in Q1 2024 [29]. Business Line Data and Key Metrics Changes - Firdapse generated revenue of $83,700,000, a 25.3% increase year over year, driven by strong adoption among newly diagnosed patients [7][26]. - Agamry's net product revenues totaled $22,000,000, compared to $1,200,000 in Q1 2024, reflecting its first full quarter of sales [9][26]. - Fycompa's net product revenue was $35,600,000, representing a year-over-year growth of 17.1% [11][27]. Market Data and Key Metrics Changes - Approximately 20% to 25% of current Firdapse patients are cancer-associated LEMS patients, with expectations to grow this segment significantly [47][90]. - The market size for LEMS is estimated at $1,200,000,000, with the company currently holding about 25% market penetration [95]. Company Strategy and Development Direction - The company aims to expand its market leadership for Firdapse and enhance its growth through strategic initiatives targeting cancer-associated LEMS patients [8][19]. - Business development remains a core growth lever, focusing on opportunities with strategic synergy and clinical differentiation [15][54]. - The company is committed to expanding access to rare disease therapies in international markets, including Japan and Canada [13][14]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining operational excellence and delivering durable growth while addressing the needs of rare disease patients [16][34]. - The company reaffirmed its full-year total product revenue guidance of between $545,000,000 and $565,000,000 for 2025 [16][25]. Other Important Information - The company has a strong cash position of $580,700,000, allowing for financial flexibility to support R&D and strategic initiatives [6][33]. - Research and development expenses increased to $3,900,000 in Q1 2025 from $2,600,000 in Q1 2024, reflecting ongoing investments in clinical studies [32]. Q&A Session Summary Question: How much of Firdapse's growth is attributed to the Change Healthcare impact? - Management indicated that if the Change Healthcare impact is backed out, Firdapse would still be in the 15% to 20% growth range [39][40]. Question: What proportion of Fycompa patients are on the tablet versus oral suspension? - Approximately 98% of Fycompa patients are on the tablet formulation [42]. Question: How is the uptake of Firdapse among small cell lung cancer patients trending? - Currently, about 20% to 25% of LEMS patients on Firdapse are cancer-associated, with plans to increase this through screening initiatives [47][90]. Question: What are the current thoughts on business development in the changing macro environment? - The company remains focused on immediately accretive opportunities and sees the current market dynamics as beneficial for its strategy [54][55]. Question: What gives confidence in the strategy for cancer-associated LEMS? - There is significant interest from the oncology community in diagnosing and treating cancer-associated LEMS, indicating a strong unmet need [58][60].

Financial Data and Key Metrics Changes - Total net revenues increased by 43.6% year over year to $141,400,000, with significant contributions from all products [4][26] - Net income before income taxes for Q1 2025 was $71,300,000, a 145% increase year over year [28] - GAAP net income for Q1 2025 was $56,700,000, or $0.47 per basic share, reflecting a 144% increase year over year [28] - Non-GAAP net income for Q1 2025 was $86,600,000, or $0.71 per basic share, compared to $46,800,000 in Q1 2024 [28][29] Business Line Data and Key Metrics Changes - Firdapse generated revenue of $83,700,000, a 25.3% increase year over year [6][27] - Agamry's net product revenues totaled $22,000,000, compared to $1,200,000 in Q1 2024, marking its first full year of commercial availability [9][27] - Fycompa's net product revenue was $35,600,000, representing a year-over-year growth of 17.1% [11][28] Market Data and Key Metrics Changes - Approximately 20% to 25% of current Firdapse patients are cancer-associated LEMS patients, with expectations to increase this percentage through screening initiatives [49][90] - The market for LEMS is estimated at $1,200,000,000, with the company currently holding about 25% market penetration [94] Company Strategy and Development Direction - The company aims to expand its market leadership for Firdapse and Agamry while managing the transition of Fycompa post-patent expiry [12][15] - Strategic initiatives include enhancing patient access and focusing on business development opportunities that align with the company's goals [15][75] - The company is committed to advancing health equity by expanding access to therapies for underserved populations [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining growth momentum and achieving full-year revenue guidance of $545,000,000 to $565,000,000 [16][26] - The company is focused on executing strategic priorities and maintaining operational excellence [15][36] Other Important Information - The company ended Q1 2025 with cash and cash equivalents of $580,700,000, an increase from $517,600,000 at the end of 2024 [34] - Research and development expenses for Q1 2025 were $3,900,000, up from $2,600,000 in Q1 2024, reflecting ongoing investments in clinical studies [33] Q&A Session Summary Question: What contributed to Firdapse's growth this quarter? - Management indicated that approximately 15% to 20% growth is typical, and the strong performance in Q1 was partly due to recovery from the Change Healthcare incident [39][41] Question: What is the proportion of Fycompa patients on tablet versus oral suspension? - Approximately 85% of Fycompa patients are on the tablet formulation [44][62] Question: How is the uptake of Firdapse among small cell lung cancer patients? - Currently, 20% to 25% of LEMS patients on Firdapse are cancer-associated, with plans to increase this through screening efforts [49][90] Question: What are the company's current thoughts on business development? - The company remains focused on identifying immediately accretive opportunities and sees the current market dynamics as beneficial for its strategy [54][56] Question: How does the company plan to minimize brand erosion for Fycompa post-exclusivity? - Management noted that there is a tendency for anti-seizure medications to retain patients, which may help minimize brand erosion [70][72] Question: What is the company's market penetration for Firdapse? - The company estimates a market penetration of about 25% for Firdapse, with significant growth potential remaining [94][96]

Core Insights - Catalyst Pharmaceutical (CPRX) reported a revenue of $141.42 million for Q1 2025, marking a year-over-year increase of 43.6% and exceeding the Zacks Consensus Estimate by 8.92% [1] - The earnings per share (EPS) for the same quarter was $0.68, which is a significant increase from $0.38 a year ago, representing an EPS surprise of 28.30% over the consensus estimate of $0.53 [1] Revenue Breakdown - Product revenue from FIRDAPSE was $83.73 million, surpassing the average estimate of $77.44 million [4] - Product revenue from FYCOMPA reached $35.63 million, exceeding the estimated $31.80 million [4] - Product revenue from AGAMREE was $22.04 million, compared to the average estimate of $20.04 million [4] - Total product revenue net was $141.40 million, compared to the estimated $129.40 million, reflecting a 43.6% increase year-over-year [4] - Revenue from licenses and other sources was $0.02 million, significantly below the estimated $0.88 million, indicating a 69.1% decrease compared to the previous year [4] Stock Performance - Catalyst's shares have returned +7.8% over the past month, while the Zacks S&P 500 composite has increased by +10.6% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Catalyst Pharmaceutical (CPRX) came out with quarterly earnings of $0.68 per share, beating the Zacks Consensus Estimate of $0.53 per share. This compares to earnings of $0.38 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 28.30%. A quarter ago, it was expected that this specialty drug company would post earnings of $0.52 per share when it actually produced earnings of $0.70, delivering a surprise of 34.62%.Over the last four ...

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]

Product Approvals and Launches - FIRDAPSE® received FDA approval for pediatric use, expanding the age range for treatment to include patients six years and older[165]. - AGAMREE® was launched in March 2024, with a strategic decision to split field forces for better product support effective April 1, 2025[167][168]. - Santhera's NDA for AGAMREE® was approved by the FDA on October 26, 2023, triggering a $36 million milestone payment[186]. - AGAMREE® was launched in the U.S. on March 13, 2024, for the treatment of DMD, with significant commercialization expenses incurred in Q1 2024[187]. - AGAMREE® has received marketing authorization in the EU for patients aged four and older, with a positive benefit-risk profile acknowledged by the CHMP[192]. Financial Performance - Total revenues for Q1 2025 were approximately $141.4 million, a 43.4% increase from $98.5 million in Q1 2024[227]. - FIRDAPSE® net sales increased by 25.3% to approximately $83.7 million in Q1 2025 from $66.8 million in Q1 2024[228]. - AGAMREE® net sales reached approximately $22.0 million in Q1 2025, compared to $1.2 million in the same period of 2024[228]. - Net income for the three months ended March 31, 2025, was approximately $56.7 million, a 143% increase from $23.3 million for the same period in 2024[244]. - Cash and cash equivalents increased to $580.7 million as of March 31, 2025, up from $517.6 million at December 31, 2024[245]. Research and Development - Research and development expenses for Q1 2025 were approximately $3.9 million, up 50.6% from $2.6 million in Q1 2024, representing 5% of total operating costs[235]. - Future research and development activities may increase as the company seeks to expand indications for FIRDAPSE® and AGAMREE®[236]. - The company is exploring the potential for additional indications for AGAMREE® and the ability to commercialize these indications[264]. Market Strategy and Expansion - The company is actively pursuing global expansion opportunities for FIRDAPSE®, particularly in Asia and Latin America[173]. - The company is exploring opportunities for portfolio expansion in rare disease products, focusing on licensing and asset acquisitions[209]. - The company entered into a license agreement with KYE for AGAMREE® in Canada, with KYE responsible for obtaining regulatory approval[196]. Regulatory and Compliance - The company is focused on successfully marketing and selling FIRDAPSE®, FYCOMPA®, and AGAMREE® while ensuring compliance with federal and state regulations[263]. - The company is monitoring the compliance of third-party suppliers and contract manufacturers with Good Manufacturing Practices (cGMP)[264]. Financial Obligations and Risks - The company anticipates a decline in FYCOMPA® product revenue after patent expiration on May 23, 2025, for tablets and December 15, 2025, for oral suspension[231]. - Ongoing patent litigation against generic manufacturers may affect the market entry of generic versions of FIRDAPSE®[180]. - The company is preparing for the loss of exclusivity for FYCOMPA®, expected to occur on or after May 23, 2025, for the tablet version[203]. - The company has sufficient funds to support operations for at least the next 12 months, but future profitability and funding availability are uncertain[247]. - The company may require additional working capital depending on the success of FIRDAPSE®, FYCOMPA®, and AGAMREE® sales[248]. Operational Costs - Selling, general and administrative expenses for Q1 2025 were approximately $46.9 million, consistent with $46.9 million in Q1 2024, representing 60% of total operating costs[237]. - Cost of sales for Q1 2025 was approximately $17.9 million, compared to $12.5 million in Q1 2024, primarily due to royalty payments[232]. - Amortization of intangible assets was approximately $9.3 million for both Q1 2025 and Q1 2024[233]. Other Financial Metrics - Other income for Q1 2025 was approximately $7.9 million, significantly higher than $2.0 million in Q1 2024, driven by increased interest income and gains on equity securities[240]. - Net cash provided by operating activities was $60.0 million for the three months ended March 31, 2025, compared to $31.9 million for the same period in 2024[251]. - Net cash provided by financing activities was $3.1 million for the three months ended March 31, 2025, down from $141.0 million in 2024[253]. Tax and Interest Rate Management - The effective income tax rate was approximately 20.4% for the three months ended March 31, 2025, compared to 20.0% for the same period in 2024[242]. - The company is managing interest rate risk primarily through investments in highly liquid money market funds and U.S. Treasuries[267].

Core Points - Catalyst Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on developing and commercializing novel medicines for patients with rare diseases [1][3] - The company will participate in the BofA Securities Health Care Conference 2025 on May 14, 2025, in Las Vegas, Nevada [1][2] - Catalyst 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 [3] Presentation Details - The presentation will take place on May 14, 2025, at 8:00 am PT [2] - A webcast of the presentation will be available on the company's website, with a replay accessible for at least 14 days [2] Company Overview - Catalyst Pharmaceuticals is committed to improving the lives of patients with rare diseases through innovative therapies and a comprehensive suite of support services [3] - The company maintains a strong U.S. presence and is actively seeking to expand its global commercial footprint through strategic partnerships [3]

Core Viewpoint - Catalyst Pharmaceuticals, Inc. will release its first quarter 2025 financial results on May 7, 2025, and will host a conference call and webcast on May 8, 2025, to discuss these results and provide a business update [1][2]. Company Overview - Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients with rare and difficult-to-treat diseases [4]. - The company has a proven track record of bringing life-changing treatments to market and prioritizes patient care 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 May 8, 2025, at 8:30 AM ET [3]. - US/Canada dial-in number is (833) 316-2483, and the international dial-in number is (785) 838-9284 [3]. - The webcast will be accessible on the company's website, with a replay available for at least 30 days following the event [3].