CORAL GABLES, Fla., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst”) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today announced that it will release its fourth quarter and full-year 2023 financial results after the market close on February 28, 2024. Catalyst's management team will host a conference call and webcast the f ...

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q3 2023 Results Conference Call November 9, 2023 8:30 AM ET Company Participants Ali Grande - Chief Financial Officer Patrick McEnany - Chairman and Chief Executive Officer Steven Miller - Chief Operating Officer and Chief Scientific Officer Jeffrey Del Carmen - Chief Commercial Officer Conference Call Participants Les Sulewski - Truist Securities Charles Duncan - Cantor Fitzgerald Joe Catanzaro - Piper Sandler Scott Henry - ROTH Capital Partners Operator Hello, ...

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 September 30, 2023 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 jurisdiction of incor ...

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q2 2023 Earnings Conference Call August 10, 2023 8:30 AM ET Company Participants Alicia Grande - Vice President, Chief Financial Officer and Treasurer Patrick McEnany - Chairman and Chief Executive Officer Jeffrey Del Carmen - Chief Commercial Officer Steven Miller - Chief Operating Officer and Chief Scientific Officer Conference Call Participants Joe Catanzaro - Piper Sandler Les Sulewski - Truist Securities Charles Duncan - Cantor Fitzgerald Operator Hello, and ...

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, 2023 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 jurisdiction of incorporat ...

Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) Q1 2023 Earnings Conference Call May 11, 2023 8:30 AM ET Company Participants Patrick McEnany - Chairman, Chief Executive Officer Alicia Grande - Vice President, Chief Financial Officer Jeff Del Carmen - Chief Commercial Officer Steven Miller - Chief Operating Officer, Chief Scientific Officer Conference Call Participants Les Sulewski - Truist Securities Joe Catanzaro - Piper Sandler Pete Stavropoulos - Cantor Fitzgerald Operator Greetings and welcome to the Catal ...

Catalyst's New Drug Application for FIRDAPSE ®(amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome (LEMS) was approved in 2018 by the U.S. Food & Drug Administration (FDA), and FIRDAPSE ®is commercially available in the United States as a treatment for adults with LEMS. Further, Canada's national healthcare regulatory agency, Health Canada, approved the use of FIRDAPSE ®for the treatment of adult patients in Canada with LEMS in 2020 and FIRDAPSE ®is commercially a ...

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q4 2022 Earnings Conference Call March 16, 2023 8:30 AM ET Company Participants Alicia Grande - VP, CFO, and Treasurer Patrick J. McEnany - Chairman, President, and CEO Jeff Del Carmen - Chief Commercial Officer Steven R. Miller - COO and CSO Conference Call Participants Joseph Catanzaro - Piper Sandler Pete Stavropoulos - Cantor Fitzgerald Unidentified Analyst - Truist Securities Scott Henry - ROTH Capital Partners Operator Greetings and welcome to the Catalyst ...

Financial Performance - For the year ended December 31, 2022, the company recognized $213.9 million in net revenue from product sales of FIRDAPSE®, a 55% increase from $138.0 million in 2021, driven by a 49% increase in sales volume [46]. - Selling, general and administrative expenses increased to approximately $58.2 million in 2022, up from $49.6 million in 2021, accounting for 52% of total operating costs [31]. - Other income for 2022 was $2.9 million, up from $0.3 million in 2021, attributed to higher yields on investments and increased invested balances [50]. - Total selling, general, and administrative expenses for 2022 were $58.2 million, a 17.2% increase from $49.6 million in 2021 [58]. - Employee stock-based compensation increased to $7.9 million in 2022 from $6.1 million in 2021, reflecting a 29.5% rise [59]. - As of December 31, 2022, the company had cash and investments of approximately $298 million, which decreased to $136 million after the FYCOMPA® acquisition [92]. Research and Development - The company incurred total research and development expenses of $19.8 million for the year ended December 31, 2022, representing a 16.8% increase from $16.9 million in 2021 [30]. - Research and development expenses for 2022 were approximately $19.8 million, representing about 18% of total operating costs, an increase of $2.9 million from 2021 [48]. - The increase in research and development expenses was primarily due to a one-time acquisition of RUZURGI® inventory costing approximately $4.1 million [48]. - The company expects substantial research and development expenses to continue in 2023 as it seeks to acquire innovative technology platforms in rare disease categories [48]. Acquisitions and Partnerships - The acquisition of FYCOMPA® included an upfront payment of $160 million and a potential additional payment of $25 million if a patent extension is approved [34]. - The company is exploring additional opportunities to acquire companies with commercial drug products or products in development to diversify its portfolio [34]. - The company has entered into a definitive agreement with Endo for the development and commercialization of generic Sabril® tablets, with an upfront payment of $500,000 and a potential milestone payment of $2.0 million [61]. - The company is exploring additional acquisition opportunities in rare disease and CNS therapeutic categories to diversify its product portfolio [91]. Product Development and Marketing - FYCOMPA® is the first and only AED targeting the AMPA receptor, with ongoing efforts to market this product [54]. - The company expects to hire approximately 34 sales and marketing personnel to support the marketing of FYCOMPA® [34]. - FYCOMPA® is expected to be marketed by the company through its own sales team starting May 2023, with plans to hire approximately 34 sales and marketing personnel [89]. - The company plans to expand FIRDAPSE® commercialization efforts into Japan and other Asian territories upon approval [93]. Regulatory and Legal Matters - The company filed lawsuits against three generic drug manufacturers to protect its patents for FIRDAPSE® following Paragraph IV Certification Notice Letters received in January 2023 [33]. - The company has filed lawsuits against three generic drug manufacturers following Paragraph IV Certification Notice Letters received in January 2023, which challenge the validity of six patents listed in the FDA Orange Book for FIRDAPSE® [128]. - The company is required to conduct a pediatric safety study and has established a pregnancy surveillance program for FIRDAPSE® [112]. Market and Competitive Landscape - The pharmaceutical industry is highly competitive, with many organizations having greater resources than the company [66]. - The company faces significant competition in the biotechnology and pharmaceutical industries, with competitors having greater financial resources and experience [204]. - The commercial success of the company's drug products will depend on third-party payor coverage and reimbursement, which may not be sufficient to ensure profitability [212]. Patient Access and Support Programs - The company has a co-pay assistance program that reduces out-of-pocket costs for LEMS patients to no more than $10.00 per month, currently averaging less than $2.00 per month [88]. - The company is committed to patient access programs to ensure no LEMS patient is denied access to FIRDAPSE® for financial reasons [93]. - Catalyst Pathways® is a personalized treatment support program that assists patients in managing the dosing and titration regimen for FIRDAPSE® [82]. Intellectual Property and Patent Protection - The company aims to maintain its patent protection for FIRDAPSE® to prevent generic competition after orphan drug exclusivity expires [86]. - The company holds patent rights for FIRDAPSE® with a patent expiration date of April 7, 2034, protecting specific dosing regimens [127]. - Catalyst Pharmaceuticals emphasizes the importance of protecting its intellectual property and regulatory exclusivities as a strategic priority for future success [128]. Operational Challenges - The company is reliant on third-party contract manufacturers for production, which poses risks related to compliance with current good manufacturing practices (cGMP) and potential disruptions in supply [209]. - The ongoing COVID-19 pandemic may adversely affect the company's business operations and financial results [219]. - The company may encounter difficulties in managing growth, which could adversely affect its financial condition and operational results [211].

Financial Data and Key Metrics Changes - Catalyst Pharmaceuticals reported a record quarterly net product revenue of $57.2 million for Q3 2022, representing a 59.3% increase compared to Q3 2021 [5][44] - GAAP net income for Q3 2022 was $22.7 million, or $0.22 per basic share, reflecting a 120.2% increase year-over-year [6][45] - Non-GAAP net income for Q3 2022 was $28.6 million, or $0.28 per basic share, which is an 83.3% increase compared to Q3 2021 [7][48] - The company ended Q3 2022 with $256 million in cash and short-term investments, marking a $35.3 million increase from the previous quarter [9][55] Business Line Data and Key Metrics Changes - Firdapse net sales for Q3 2022 were $57.2 million, showing an 8% growth quarter-over-quarter and a 59.3% growth year-over-year [22] - The discontinuation rate of reimbursed patients in Q3 was 35% lower than in Q2, indicating improved patient retention [23] - Average co-pay for patients enrolled in Catalyst Pathways was less than $2 per month, facilitating access to treatment [24] Market Data and Key Metrics Changes - Approximately 50% of LEMS patients have a comorbidity of small cell lung cancer, representing a significant market opportunity for Catalyst [11] - The company estimates that there are about 1,500 small cell lung cancer LEMS patients in the U.S., with over 80% currently undiagnosed [27] Company Strategy and Development Direction - Catalyst aims to broaden and diversify its product portfolio through acquisitions and partnerships, with ongoing due diligence for potential commercial stage products [15][42] - The company has launched a marketing initiative targeting thoracic oncologists to educate them about LEMS and Firdapse, expected to ramp up in early 2023 [11][28] - Catalyst is focused on expanding access to Firdapse for all LEMS patients, including pediatric patients aged six and older, following recent FDA approval [14][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2022 objectives, revising Firdapse revenue guidance upward to $205 million to $210 million [8] - The company anticipates continued organic growth driven by new patient enrollments and improved diagnostic efforts [24][80] - Management acknowledged the potential for challenges to their patent position but indicated preparedness for such events [80] Other Important Information - Catalyst was named Company of the Year by BioFlorida and ranked 39th in Fortune Magazine's 2022 Top 100 Fastest Growing Companies [17][18] - The company was added to the S&P SmallCap 600 Index on September 15, 2022, reflecting its market capitalization and growth [19] Q&A Session Summary Question: How many patients are currently offered Firdapse, and how many are small cell lung cancer patients? - Management indicated that about 30% of new enrollments are small cell lung cancer LEMS patients, with expectations for growth in this area [60] Question: What is the target for small cell lung cancer patients in 2023? - The company expects to increase the percentage of small cell lung cancer patients among new enrollments from 30% to about 35% to 40% in 2023 [61] Question: Is the patient growth from breadth or depth in the prescriber base? - The prescriber base is broad, with 75% of prescribers treating only one patient, indicating potential for future growth as physicians gain experience [66] Question: Are there differences in persistence between treatment naïve patients and those switching from Ruzurgi? - No significant differences in persistence were observed between the two groups, with both groups showing similar treatment adherence [68] Question: What is the current status of patients on Ruzurgi for other indications? - Approximately 100 patients with congenital myasthenic syndromes are being treated with Ruzurgi under INDs, but no specific plans to pursue this indication currently exist [72]