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Catalyst Pharmaceuticals(CPRX) - 2022 Q3 - Quarterly Report
2022-11-08 16:00
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, 2022 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(CPRX) - 2022 Q2 - Earnings Call Transcript
2022-08-10 18:00
Financial Data and Key Metrics Changes - Catalyst Pharmaceuticals reported an all-time high in total FIRDAPSE net revenue of $53 million for Q2 2022, representing a 57.7% increase compared to the same period last year [6] - Net income before income taxes for Q2 2022 was $28.2 million, a 77.6% increase compared to $15.9 million for Q2 2021 [7] - GAAP net income for Q2 2022 was $21.6 million, or $0.21 per basic share and $0.20 per diluted share, reflecting a 77.5% increase year-over-year [49] - The company ended Q2 2022 with $220.8 million in cash and investments and no funded debt [7][57] Business Line Data and Key Metrics Changes - FIRDAPSE net sales for Q2 2022 were $53 million, showing a 23.3% growth quarter-over-quarter and a 57.7% growth year-over-year [22] - The company successfully transitioned nearly 100% of adult LEMS patients from Ruzurgi to FIRDAPSE without a lapse in therapy [23] - Payer approval rates for adult LEMS patients transitioning from Ruzurgi were greater than 90% [24] Market Data and Key Metrics Changes - The company expects steady organic growth in the second half of 2022, primarily driven by new patient enrollments of already diagnosed LEMS patients not yet on FIRDAPSE [26] - Leading indicators for Q3 are positive, with July net new patients ahead of forecast due to low discontinuation rates and consistent new enrollments [27] Company Strategy and Development Direction - Catalyst Pharmaceuticals aims to broaden and diversify its product portfolio through collaborative partnerships and acquisitions of commercial stage assets [17] - The company is actively engaged in advanced stages of due diligence for several acquisition opportunities [18] - The company has made significant progress in building its ESG program, publishing its inaugural set of industry-specific disclosures [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, believing the company is well-positioned to execute its growth strategy and deliver long-term value for stakeholders [21] - The company anticipates that 2022 will continue to be a transformative year with increased momentum to diversify and invest in innovative opportunities for rare diseases [60] Other Important Information - The company resolved issues with Jacobus Pharmaceuticals, acquiring certain intellectual property rights, including U.S. and Mexico rights for Ruzurgi [12] - A supplemental new drug application for FIRDAPSE to support its use in pediatric LEMS patients has been accepted by the FDA for review [15] Q&A Session Summary Question: What are the key factors to achieve the upper end of revenue guidance? - Management indicated that strong new patient enrollments and low discontinuation rates are crucial for achieving the upper end of revenue guidance [64] Question: What information was provided to the FDA regarding the pediatric LEMS supplemental application? - The company submitted pediatric safety data and simulations on how adult data translates to pediatric patients [67] Question: Will potential business development activities be accretive to revenue opportunities next year? - Management expects that any potential business development activities would be accretive to revenues next year, leveraging established commercial infrastructure [68] Question: What is the expected pace of naïve new patient enrollments in the second half of the year? - Management expects the pace of growth to continue, with strong new enrollments and steady discontinuation rates [74] Question: What does the newly acquired patent cover? - The patent contains claims for a new and novel previously unknown impurity that appears in all products containing amifampridine [78]
Catalyst Pharmaceuticals(CPRX) - 2022 Q2 - Quarterly Report
2022-08-08 16:00
Table of Contents Title of Each ClassTicker SymbolName of Exchange on Which Registered Common Stock, par value $0.001 per share CPRX NASDAQ Capital Market Emerging growth company ☐ 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, 2022 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File ...
Catalyst Pharmaceuticals (CPRX) Investor Presentation - Slideshow
2022-05-26 18:18
| --- | --- | |------------------------------|-------| | | | | Dedicated To Making A | | | Meaningful Difference In The | | | Lives Of Patients | | | Suffering From Rare Diseases | | NASDAQ: CPRX May 2022 1 Confidential Safe Harbor 2 Confidential This presentation contains forward-looking statements that are subject to a number of risks and uncertainties, many of which are outside our control. All statements regarding our strategy, future operations, financial position, estimated revenues or losses, project ...
Catalyst Pharmaceuticals(CPRX) - 2022 Q1 - Earnings Call Transcript
2022-05-11 15:43
Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q1 2022 Earnings Conference Call May 11, 2022 8:30 AM ET Company Participants Ali Grande - Vice President, Chief Financial Officer and Treasurer Patrick McEnany - Chairman and Chief Executive Officer Jeff Del Carmen - Chief Commercial Officer Steven Miller - Chief Operating Officer and Chief Scientific Officer Conference Call Participants Joe Catanzaro - Piper Sandler Charles Duncan - Cantor Fitzgerald Les Sulewski - Truist Securities Scott Henry - ROTH Capital O ...
Catalyst Pharmaceuticals(CPRX) - 2022 Q1 - Quarterly Report
2022-05-09 16:00
Table of Contents Title of Each ClassTicker SymbolName of Exchange on Which Registered Common Stock, par value $0.001 per share CPRX NASDAQ Capital Market Emerging growth company ☐ 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 March 31, 2022 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission Fil ...
Catalyst Pharmaceuticals(CPRX) - 2021 Q4 - Earnings Call Transcript
2022-03-17 20:36
Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q4 2021 Earnings Conference Call March 17, 2022 8:30 AM ET Company Participants Patrick McEnany - Co-Founder, Chairman, President and CEO Alicia Grande - VP, CFO and Treasurer Steven Miller - COO and Chief Scientific Officer Jeff Del Carmen - Chief Commercial Officer Gary Ingenito - Chief Medical and Regulatory Officer Conference Call Participants Joseph Catanzaro - Piper Sandler Charles Duncan - Cantor Fitzgerald Scott Henry - ROTH Capital Partners Joon Lee - Tr ...
Catalyst Pharmaceuticals(CPRX) - 2021 Q4 - Annual Report
2022-03-15 16:00
Table of Contents Title of Each Class Ticker SymbolName of Exchange on Which Registered Common Stock, par value $0.001 per share CPRX NASDAQ Capital Market Emerging Growth Company ☐ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [Mark One] ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission F ...
Catalyst Pharmaceuticals(CPRX) - 2021 Q3 - Earnings Call Transcript
2021-11-10 17:56
Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q3 2021 Earnings Conference Call November 10, 2021 8:30 AM ET Company Participants Patrick McEnany – Chairman and Chief Executive Officer Ali Grande – CFO Steven Miller – Chief Operating Officer and Chief Scientific Officer Jeffrey Del Carmen – Chief Commercial Officer Gary Ingenito – Chief Medical and Regulatory Officer Conference Call Participants Charles Duncan – Cantor Fitzgerald Scott Henry – ROTCE Capital Joseph – from Piper Sandler Joon Lee – Truist Operat ...
Catalyst Pharmaceuticals(CPRX) - 2021 Q3 - Quarterly Report
2021-11-08 16:00
Table of Contents Title of Each ClassTicker SymbolName of Exchange on Which Registered Common Stock, par value $0.001 per share CPRX NASDAQ Capital Market Emerging growth company ☐ 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, 2021 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission ...