Core Insights - Catalyst Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on developing and commercializing novel medicines for patients with rare and difficult-to-treat diseases [1][3] - The company will participate in Citi's 2025 Global Healthcare Conference on December 2, 2025, with a presentation scheduled for 1:00 PM ET [2] Company Overview - Catalyst Pharmaceuticals is committed to improving the lives of patients with rare diseases, emphasizing in-licensing, commercialization, and development of innovative therapies [3] - The company has a strong U.S. presence, which is central to its commercial strategy, while also exploring opportunities for global expansion [3] - 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]

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].

Core Viewpoint - Catalyst Pharmaceutical (CPRX) has shown a 7.2% increase in stock price over the past four weeks, with a mean price target of $34.5 indicating a potential upside of 51.5% from the current price of $22.78 [1] Price Targets and Analyst Consensus - The average price target consists of eight estimates ranging from a low of $32.00 to a high of $40.00, with a standard deviation of $2.67, suggesting a relatively tight clustering of estimates [2] - The lowest estimate indicates a 40.5% increase, while the highest suggests a 75.6% upside, highlighting the variability in analyst predictions [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement direction, which can serve as a starting point for further research [9] Earnings Estimates and Analyst Optimism - Analysts have shown growing optimism regarding CPRX's earnings prospects, as evidenced by a positive trend in earnings estimate revisions, which correlates strongly with near-term stock price movements [11] - Over the last 30 days, three earnings estimates have been revised upward, resulting in a 7.3% increase in the Zacks Consensus Estimate [12] Zacks Rank and Investment Potential - CPRX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside in the near term [13] - While the consensus price target may not be entirely reliable, the implied direction of price movement appears to be a useful guide for investors [14]

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]

Product Overview - The company currently markets three drug products: FIRDAPSE®, AGAMREE®, and FYCOMPA®[168] - FIRDAPSE® received FDA approval in November 2018 and was launched in the U.S. in January 2019, with a recent sNDA approval increasing the maximum daily dosage from 80 mg to 100 mg[171] - The FDA approved AGAMREE® for treating Duchenne muscular dystrophy (DMD) in patients aged two years and older on October 26, 2023[192] - AGAMREE® received marketing authorization from the European Commission on December 18, 2023, for DMD patients aged four and older[199] - AGAMREE® was launched for the treatment of DMD in the U.S. on March 13, 2024, with significant commercialization expenses incurred during the first quarter of 2024[193] Financial Performance - Total revenues for the three and nine months ended September 30, 2025, were approximately $148.4 million and $436.4 million, respectively, compared to $128.7 million and $349.9 million for the same periods in 2024, representing an increase of 15.5% and 24.7%[233][234] - FIRDAPSE® net product revenue increased to approximately $92.2 million and $260.8 million for the three and nine months ended September 30, 2025, up from approximately $79.3 million and $223.5 million in 2024, reflecting a growth of 16.2% and 16.7%[235] - AGAMREE® net product revenue was approximately $32.4 million and $81.8 million for the three and nine months ended September 30, 2025, compared to approximately $15.0 million and $25.0 million in 2024, indicating significant growth following its commercial launch in March 2024[236] - FYCOMPA® net product revenue decreased by approximately $8.3 million or 25.8% for the three months and $5.3 million or 5.3% for the nine months ended September 30, 2025, due to generic competition following patent expiration[239] - Net income for Q3 2025 was $52.8 million ($0.43 per basic share), compared to $43.9 million ($0.37 per basic share) in Q3 2024, reflecting a 20.3% increase[255] - For the nine months ended September 30, 2025, net income was $161.6 million ($1.32 per basic share), compared to $108.0 million ($0.92 per basic share) in the same period of 2024, representing a 49.7% increase[255] Research and Development - A Phase 1 study is currently underway to evaluate the immunosuppressive effects of AGAMREE® for future indications, with results expected by the end of Q1 2026[200] - The company expects future research and development activities to become more significant as it seeks to expand its portfolio and develop additional indications for FIRDAPSE® and AGAMREE®[246] Expenses and Costs - Research and development expenses for the three months ended September 30, 2025, were approximately $2.7 million, a decrease of 19.1% from $3.3 million in 2024, while for the nine months, expenses increased to approximately $10.9 million from $8.9 million, a rise of 23.2%[245] - Cost of sales for the three and nine months ended September 30, 2025, were approximately $22.7 million and $61.2 million, respectively, compared to $19.3 million and $47.2 million in 2024, reflecting an increase of 17.6% and 29.7%[241] - Selling, general and administrative expenses for Q3 2025 were approximately $47.5 million, a 3.5% increase from $45.9 million in Q3 2024, representing 58% and 59% of total operating costs, respectively[247] - For the nine months ended September 30, 2025, selling, general and administrative expenses totaled approximately $140.3 million, up 5.1% from $133.5 million in the same period of 2024[248] Cash and Investments - The company had cash and investments of approximately $689.9 million as of September 30, 2025, sufficient to support operations for at least the next 12 months[214] - Cash and cash equivalents as of September 30, 2025, were $689.9 million, up from $517.6 million at December 31, 2024[256] - Net cash provided by operating activities for the nine months ended September 30, 2025, was $163.8 million, compared to $168.9 million for the same period in 2024[263] Agreements and Collaborations - The company entered into a License and Collaboration Agreement with Santhera Pharmaceuticals for AGAMREE® and made a $75 million payment for exclusive North American rights[190] - The company is obligated to make a milestone payment of $36 million to Santhera following the NDA approval for AGAMREE®[192] - The company agreed to pay Jacobus a total of $30 million in cash related to a settlement, with $10 million paid at closing, $10 million on the first anniversary, and $10 million on the second anniversary[270] - The annual royalty on Catalyst's net sales of amifampridine products in the U.S. is set at 1.5% for 2022-2025 (minimum $3 million per year) and 2.5% for 2026 until patent expiration (minimum $5 million per year)[271] Market and Competition - The estimated number of DMD patients in the U.S. is between 11,000 and 13,000, with approximately 70% currently receiving corticosteroid treatment[197] - The company faces uncertainties regarding the successful commercialization of FIRDAPSE®, AGAMREE®, and FYCOMPA®, including market size estimates and competition from generics[275] Stock and Share Repurchase - A new share repurchase program was authorized on October 1, 2025, allowing for the repurchase of up to $200 million in common stock[215] - As of November 3, 2025, the company repurchased 405,092 shares for an aggregate purchase price of approximately $8.4 million, averaging $20.74 per share[216] Other Financial Metrics - License and other revenue for the three and nine months ended September 30, 2025, was $27 thousand and $71 thousand, respectively, compared to $2.3 million and $2.4 million in 2024, indicating a significant decline due to the absence of milestone payments[240] - Other income, net for Q3 2025 was $4.8 million, down from $6.3 million in Q3 2024, primarily due to a decrease in the share price of investments[251] - The effective income tax rate for the nine months ended September 30, 2025, was approximately 23.6%, slightly lower than 24.0% for the same period in 2024[253] - Total stock-based compensation for Q3 2025 was $5.7 million, an increase from $4.4 million in Q3 2024, and for the nine months, it was $19.1 million compared to $17.1 million in the same period of 2024[250] Marketing and Awareness - The company has expanded its digital and social media activities to increase awareness of its products among potential patients and healthcare providers[176]