The exercise-and-sell transaction came as the rare disease drugmaker reported strong quarterly results. Jeffrey Del Carmen, Chief Commercial Officer of Catalyst Pharmaceuticals (CPRX +0.26%), exercised and immediately sold 10,983 shares of common stock on November 26, 2025, for a total value of approximately $256,200, as disclosed in this SEC Form 4 filing.Transaction summaryMetricValueShares sold10,983Transaction value~$256,200Post-transaction shares3,962Post-transaction value (direct ownership)~$92,800Tra ...

Group 1 - Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) is considered a cheap healthcare stock with a consensus Buy rating from all seven analysts covering it, indicating a potential upside of 48.75% from its current price of $35 [1] - The company is focused on advancing education in the oncology space and accelerating organic growth by targeting patients at various stages of the diagnostic journey, despite competition in the epilepsy market [3] - Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company based in Florida, founded in 2002, and offers treatments such as Firdapse, Fycompa, Ruzurgi, and AGAMREE for life-threatening diseases [4] Group 2 - On November 26, the Chief Commercial Officer of Catalyst Pharmaceuticals, Jeffrey Del Carmen, sold 10,983 shares of common stock for approximately $256,244, leaving him with 3,962 shares [2]

Summary of Catalyst Pharmaceuticals Conference Call Company Overview - **Company**: Catalyst Pharmaceuticals (NasdaqCM: CPRX) - **Key Products**: Agamree and Firdapse - **Focus**: Rare diseases and orphan drug development Key Points Business Development and Licensing - Catalyst Pharmaceuticals is focused on business development (BD) and licensing as core components of its strategy, particularly concerning Firdapse's intellectual property (IP) resolution before significant capital deployment [4][5][18] - The company has assessed over 100 opportunities since the beginning of the year, indicating a proactive approach to identifying potential acquisitions [6][7] Financial Position - Catalyst has approximately $689 million in cash and no funded debt, positioning it as a strong bidder in the market [9] - The company is cautious about entering bidding wars with larger players and aims to focus on opportunities that are immediately accretive or nearly so [5][9] Product Performance and Market Potential - Firdapse has the potential to exceed $500 million in revenue, with a focus on lifecycle management to optimize patient engagement and product usage [11][12] - Agamree is showing promising patient sourcing, with 45% from Emflaza, 45% from Prednisone, and 10% naive patients, indicating strong market acceptance [29][30] - The addressable market for steroids is estimated to be above $1 billion, with the potential for significant growth if the product proves effective in clinical trials [33][34] Clinical Trials and Research - The SUMMIT trial is critical for validating the efficacy of Agamree, with expectations of positive outcomes based on previous trials [35][36] - The company is conducting a phase one study to determine the immunosuppressive dose of Agamree, which could open new therapeutic avenues [15][17] Intellectual Property and Litigation - Catalyst is actively defending its IP for Firdapse, having settled with three out of four defendants in ongoing litigation [18][50] - The company believes its patent estate is robust, which is crucial for maintaining market exclusivity [50][69] Market Dynamics and Competitive Landscape - The company is facing generic competition for Fycompa, but brand stickiness is reportedly holding up better than expected [63][64] - The introduction of generics has not significantly dented Firdapse's business, indicating strong market positioning and patient loyalty [70] Future Outlook and Strategic Focus - Catalyst aims to expand its portfolio into other rare conditions requiring long-term steroid use, focusing on patient populations that can benefit most from its products [46][48] - The company is also exploring opportunities in the oncology space, particularly for cancer-associated LEMS patients, which could enhance its market reach [55][76] Capital Allocation - A $200 million share repurchase program has been authorized, signaling confidence in the company's financial health while maintaining flexibility for business development [66][67] - The company is committed to balancing capital allocation between share buybacks and potential acquisitions [67] Payer Coverage and Market Access - Payer coverage for Agamree is improving, with nearly 90% of prescriptions being approved, indicating growing acceptance among insurers [39][40] - The company is working to streamline the process for patients to access its therapies, which is critical for maintaining market share [39][40] Conclusion Catalyst Pharmaceuticals is strategically positioned in the rare disease market with a strong financial foundation and a focus on innovative product development. The company is actively managing its IP, exploring new market opportunities, and optimizing its existing product lines to drive growth and enhance shareholder value.

Core Insights - Catalyst Pharmaceuticals 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 [2] - Total revenues for the quarter reached $148.4 million, reflecting a 15% year-over-year growth and surpassing the Zacks Consensus Estimate of $136 million [3] - The company raised its full-year sales guidance for 2025, now expecting total revenues between $565 million and $585 million, an increase from the previous range of $545 million to $565 million [8] Financial Performance - Firdapse sales amounted to $92.2 million, a 16% increase year-over-year, beating the Zacks Consensus Estimate of $91.8 million [4] - Agamree generated revenues of $32.4 million, more than doubling year-over-year and exceeding the Zacks Consensus Estimate of $29.5 million [5] - Fycompa revenues were reported at $23.8 million, down 26% year-over-year due to generic competition, but still beating the Zacks Consensus Estimate of $15.2 million [6] Cash Position - As of September 30, 2025, Catalyst Pharmaceuticals had cash, cash equivalents, and investments totaling $689.9 million, up from $652.8 million as of June 30, 2025 [7] Revenue Guidance - Firdapse revenues are projected to remain between $355 million and $360 million, while Agamree revenues are now expected to be in the range of $105 million to $115 million [9] - Fycompa revenue guidance has been raised to $100 million to $110 million, up from the previous range of $90 million to $95 million [9] Market Sentiment - Estimates for Catalyst Pharmaceuticals have trended upward, with a consensus estimate shift of 6.06% over the past month [10] - The stock has an aggregate VGM Score of B, with a strong value grade of A, indicating favorable conditions for value investors [12] Industry Context - Catalyst Pharmaceuticals operates within the Zacks Medical - Drugs industry, where another player, United Therapeutics, reported revenues of $799.5 million, reflecting a year-over-year increase of 6.8% [14] - United Therapeutics is expected to post earnings of $6.74 per share for the current quarter, representing a year-over-year change of 8.9% [15]

Financial Data and Key Metrics Changes - The company reported a strong cash position with $689.9 million in cash and cash equivalents and no funded debt, indicating financial stability and capacity for acquisitions [63] - The company anticipates a mid-term growth rate of 15%-20% for Firdapse as it continues to optimize patient adherence and retention strategies [58][59] Business Line Data and Key Metrics Changes - Firdapse has been on the market since 2019 and is focused on Lambert-Eaton myasthenic syndrome (LEMS), with a significant opportunity for growth in both idiopathic and cancer-associated segments [2][6] - Agamree, aimed at treating Duchenne muscular dystrophy, is expected to penetrate the market further, with 95% of patients having received steroids but only 70% currently on treatment [17][59] - Fycompa, while experiencing revenue decline due to generic competition, has overperformed expectations despite losing patent protection [3][5] Market Data and Key Metrics Changes - The total addressable market for Agamree is estimated at $1.2 billion, with potential for significant growth if the product demonstrates superiority over existing treatments [17][51] - The company has achieved 95% penetration in the top 100 centers of excellence (COEs) for DMD, indicating strong market adoption [13] Company Strategy and Development Direction - The company is focused on a buy-and-build strategy, seeking to acquire de-risked products that are either on the market or near market approval [4] - The strategy includes optimizing existing products and exploring further development opportunities in the pipeline, particularly in rare diseases [4][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming the decline of Fycompa through strong patient adherence programs and continued growth in Firdapse and Agamree [55][56] - The company is optimistic about the potential for Agamree to expand beyond Duchenne muscular dystrophy into other rare conditions requiring steroid treatment [11][20] Other Important Information - The company has settled three out of four patent challenges, extending the exclusivity of Firdapse until February 2035, which is crucial for maintaining market position [52][53] - The management emphasized the importance of education and awareness among physicians to improve diagnosis rates for LEMS, particularly in the oncology segment [28][30] Q&A Session Summary Question: What is the peak market opportunity for Agamree? - The peak market opportunity for Agamree is estimated at $1.4 billion, with a conservative total addressable market of $1.2 billion based on current treatment rates [17][51] Question: How is the company addressing the decline of Fycompa? - The company is implementing strong patient adherence programs and optimizing dosing strategies to reduce discontinuation rates and maintain revenue [55][56] Question: What is the company's approach to business development? - The ideal business development opportunity involves rare diseases with peak sales potential around $500 million, focusing on products that are immediately accretive [60][62] Question: How does the company plan to penetrate the idiopathic LEMS market? - The company plans to leverage increased awareness and testing for generalized myasthenia gravis to identify and convert potential LEMS patients [39][40]

Financial Data and Key Metrics Changes - The company reported a strong cash position of $689.9 million with no funded debt, indicating financial stability and capacity for acquisitions [63] - The company anticipates a mid-term growth rate of 15%-20% for Firdapse as it continues to optimize patient adherence and retention strategies [58][59] Business Line Data and Key Metrics Changes - Firdapse has been on the market since 2019 and is focused on Lambert-Eaton myasthenic syndrome (LEMS), with a significant opportunity for growth in both idiopathic and cancer-associated segments [2][6] - Agamree, targeting Duchenne muscular dystrophy, is expected to penetrate the market further, with a total addressable market estimated at $1.4 billion [17][51] - Fycompa, while experiencing revenue decline due to generic competition, has overperformed expectations despite losing patent protection [3][5] Market Data and Key Metrics Changes - The company has achieved 95% penetration in the top 100 Centers of Excellence (COEs) for DMD, indicating strong market adoption [13] - The cancer-associated LEMS market remains largely untapped, with 90% of patients currently undiagnosed, presenting a significant growth opportunity [28] Company Strategy and Development Direction - The company is focused on a buy-and-build strategy, seeking to acquire de-risked products that are either on the market or near market [4] - The management emphasizes the importance of education and changing care pathways to increase diagnosis rates for LEMS, particularly in oncology settings [24][30] - The company is considering moving further back into the pipeline for future development opportunities as it seeks to accelerate growth [65] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming the decline of Fycompa through strong patient adherence programs and optimizing existing products [55] - The company is optimistic about the potential of Agamree, especially if it can demonstrate superiority over standard steroids in various health outcomes [17][19] - The management acknowledged the challenging market environment but remains focused on executing its growth strategy [65] Other Important Information - The company has settled three out of four patent challenges, providing a clearer path for market stability through February 2035 [52][53] - The management highlighted the importance of leveraging its strong infrastructure to support rare disease treatments and patient retention [62] Q&A Session Summary Question: What is the peak market opportunity for Agamree? - The company estimates a $1.4 billion opportunity for Agamree, with potential for a 25% market share if it can demonstrate superiority over competitors [17][51] Question: How is the education and diagnosis process for cancer-associated LEMS progressing? - The company is actively educating oncologists and has seen a significant increase in VGCC antibody tests, indicating progress in diagnosis [34][28] Question: What is the strategy for Firdapse moving forward? - The company plans to continue optimizing patient adherence and retention, aiming for a mid-term growth rate of 15%-20% [58][59] Question: What is the company's approach to business development? - The ideal business development opportunity focuses on rare diseases with peak sales potential around $500 million, allowing for strategic acquisitions [60][62] Question: How does the company view its financial health and acquisition capacity? - The company is comfortable with its cash position and can consider acquisitions exceeding $1 billion, maintaining a strong balance sheet [63]

Financial Data and Key Metrics Changes - The company reported a strong cash position with $689.9 million in cash and cash equivalents and no funded debt, indicating financial health and flexibility for future acquisitions [63] - The company anticipates a mid-term growth rate of 15%-20% for Firdapse as it continues to optimize patient adherence and reduce discontinuation rates [56][58] Business Line Data and Key Metrics Changes - Firdapse has been on the market since 2019 and is focused on Lambert-Eaton myasthenic syndrome (LEMS), with a strong emphasis on both idiopathic and cancer-associated LEMS [2][3] - Agamree, for Duchenne muscular dystrophy, is expected to penetrate the market further, with 95% of patients having received steroids, but only 70% currently on treatment [58] - The company has achieved 95% penetration in 100 Centers of Excellence (COEs) for DMD, with 100% penetration in the top 45 COEs that account for 80% of the steroid business [14] Market Data and Key Metrics Changes - The total addressable market for Agamree is estimated at $1.4 billion, with a conservative estimate of $1.2 billion based on current patient treatment rates [18][51] - The company noted that 90% of cancer-associated LEMS patients remain undiagnosed, highlighting a significant opportunity for growth through education and screening [29] Company Strategy and Development Direction - The company is focused on a buy-and-build strategy, acquiring products that are de-risked and near market, while also considering late-stage development opportunities [4] - The management is looking to deepen market penetration for both Firdapse and Agamree, with a systematic approach to education and care pathway changes [36][40] - The company aims to leverage its strong infrastructure to support patients in rare diseases, remaining therapeutically area-agnostic [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming the decline of Fycompa due to generic competition by focusing on growth in other product lines [55] - The company is optimistic about the potential for Agamree and Firdapse, citing strong patient adherence programs and ongoing education efforts [56][58] - Management acknowledged the challenging market environment but remains committed to pursuing strategic acquisitions to accelerate growth [64] Other Important Information - The company has settled three out of four patent challenges, with the remaining challenge expected to be resolved in the future, providing a clearer path for market stability [52][63] - The company has conducted over 100 assessments for potential business development opportunities since January, indicating a proactive approach to growth [62] Q&A Session Summary Question: What is the peak market opportunity for Agamree? - The company estimates the peak market opportunity for Agamree at approximately $1.4 billion, with a conservative total addressable market of $1.2 billion based on current treatment rates [18][51] Question: How is the education and screening for cancer-associated LEMS progressing? - The company is focusing on educating physicians about the undiagnosed cancer-associated LEMS patients, with significant efforts in screening and care pathway changes [29][30] Question: What is the strategy for Firdapse amidst generic competition? - The company believes it can outgrow the decline of Fycompa by optimizing patient adherence and leveraging strong educational programs [55][56]

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 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]