Catalyst Pharmaceuticals(CPRX)

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Catalyst Pharmaceuticals(CPRX) - 2022 Q3 - Earnings Call Transcript
2022-11-10 19:34
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]
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
Financial Data and Key Metrics Changes - The company reported record net product revenue of $43 million for Q1 2022, a 42.5% increase compared to Q1 2021 [6] - Net income before income taxes for Q1 2022 was $17.5 million, a 76.7% increase from $9.9 million in Q1 2021 [7] - GAAP net income for Q1 2022 was $13.2 million, or $0.13 per basic share, representing a 72.8% increase year-over-year [39] - The company ended the quarter with $198 million in cash and short-term investments, with no funded debt [46] Business Line Data and Key Metrics Changes - FIRDAPSE net sales for Q1 2022 were $43 million, reflecting a 42% growth compared to the same quarter last year [21] - The transition of patients from Ruzurgi to FIRDAPSE was successful, with over 90% of adult LEMS patients transitioned by the end of March 2022 [22] - The company anticipates the conversion of remaining patients to be completed by the end of Q2 2022 [10] Market Data and Key Metrics Changes - The company estimates approximately 3,000 LEMS patients in the U.S., with about half undiagnosed or misdiagnosed [12] - The company has identified over 500 potential new patients based on claims data and field intelligence [62] Company Strategy and Development Direction - The company aims to diversify its product portfolio through collaborative partnerships and acquisitions of commercial-stage assets [14] - The company is actively evaluating several potential opportunities for acquisition but has not entered into any agreements to date [15] - The company has fortified its intellectual property with three new patents, enhancing the commercial durability of FIRDAPSE [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining organic growth driven by newly diagnosed patients and those misdiagnosed [12] - The company reiterated its full-year 2022 total revenue guidance of $195 million to $205 million, representing a 38% to 45% increase compared to 2021 [8] - Management highlighted the importance of the favorable court ruling that removed Ruzurgi from the market, which is expected to drive additional patient enrollment [9] Other Important Information - The company has submitted a supplemental NDA for pediatric label expansion to the FDA, aiming to provide access to FIRDAPSE for pediatric LEMS patients [17] - The company received a favorable Canadian Federal Court ruling enforcing data protection for FIRDAPSE, resulting in the removal of Ruzurgi from the Canadian market [18] Q&A Session Summary Question: Transition of Ruzurgi patients to FIRDAPSE - Management confirmed that over 90% of adult LEMS patients transitioned from Ruzurgi to FIRDAPSE, with payer approval rates greater than 95% [52][53] Question: Trends in new patient enrollment - Management noted that April's new patient enrollments remained strong, almost matching March's figures, and attributed this to improved access to healthcare [54] Question: Business development activities - Management indicated they are deep into due diligence on several promising commercial opportunities, focusing on FDA-approved drugs that have not yet launched [56] Question: Revenue contributors for Q2 - Management expects the full impact of the Ruzurgi transition and strong organic growth from new patient enrollments to contribute significantly to Q2 revenue [60] Question: Pediatric LEMS patients on FIRDAPSE - Management estimated there are fewer than 20 pediatric LEMS patients currently receiving FIRDAPSE through expanded access [71] Question: Targeting tumor LEMS patients - Management reported that around 22% of new enrollments are from tumor LEMS patients, with ongoing educational efforts aimed at oncologists to increase this percentage [72] Question: Organic growth rate - Management indicated an organic growth rate of approximately 15% to 20% year-over-year, with expectations for continued strong growth as patient visits increase [75]
Catalyst Pharmaceuticals(CPRX) - 2022 Q1 - Quarterly Report
2022-05-09 16:00
Company Focus and Strategy - The company is focused on developing and commercializing novel medicines for rare diseases, with a commitment to a robust pipeline of best-in-class medicines [99]. - In 2021, the company made a strategic decision to diversify its product portfolio through acquisitions in rare disease therapeutic categories outside of neuromuscular diseases [100]. - The company is exploring several potential opportunities to acquire or in-license drug products in development, although no definitive agreements have been made to date [100]. - The company is exploring growth opportunities beyond FIRDAPSE® through acquisitions and in-licensing of product opportunities [171]. Product Information and Development - FIRDAPSE® was approved by the FDA on November 28, 2018, and launched in January 2019, with a dedicated sales force of approximately 30 personnel [107]. - The company is actively pursuing regulatory approval for FIRDAPSE® for pediatric LEMS patients, although success is not guaranteed [115]. - A Phase 3 registrational study for FIRDAPSE® in Japan was initiated by DyDo Pharma, with completion anticipated in 2023 [122]. - The company has expanded its commercial territory for FIRDAPSE® to include Japan and has the option to expand further into Asia and Latin America upon achieving certain milestones [119]. - The company is assessing the potential for its version of vigabatrin tablets to be approved by the FDA and the implications for milestone payments or royalties [171]. Financial Performance - For the three months ended March 31, 2022, the company recognized $43.0 million in net revenue from product sales of FIRDAPSE®, an increase of approximately $12.8 million or 42.4% compared to $30.2 million in the same period of 2021 [145]. - Net income for the three months ended March 31, 2022, was $13.2 million, an increase of 71.4% compared to $7.7 million for the same period in 2021 [156]. - Cash and cash equivalents and investments totaled $197.8 million as of March 31, 2022, up from $191.3 million at December 31, 2021 [157]. - Net cash provided by operating activities was $8.5 million for the three months ended March 31, 2022, compared to $3.8 million for the same period in 2021 [164]. - The company had cash and investments of approximately $198 million as of March 31, 2022, which is expected to support operations for at least the next 12 months [129]. - The company anticipates sufficient resources to support operations for at least the next 12 months [158]. Expenses and Costs - The cost of sales for the three months ended March 31, 2022, was approximately $5.9 million, compared to $4.7 million for the same period in 2021, reflecting an increase of 25.5% [146]. - Research and development expenses for the three months ended March 31, 2022, were approximately $3.4 million, representing 13% of total operating costs, compared to $3.0 million or 15% in the same period of 2021 [148]. - Selling, general and administrative expenses for the three months ended March 31, 2022, were approximately $16.4 million, an increase of 29.2% from $12.7 million in the same period of 2021 [150]. - The increase in selling, general and administrative expenses was primarily due to contributions to organizations supporting LEMS patients of approximately $2.1 million and increases in sales commissions and employee compensation [150]. - Total stock-based compensation for the three months ended March 31, 2022, was $1.9 million, compared to $1.6 million for the same period in 2021 [152]. Legal and Regulatory Matters - The company has filed lawsuits against Jacobus and PantherRx for patent infringement related to FIRDAPSE®, which are currently in the discovery stage [126]. - The company is currently involved in lawsuits against Jacobus Pharmaceutical Company for patent infringement, with the outcome uncertain [171]. - The company is pursuing additional patent applications for FIRDAPSE® to further protect its intellectual property, although there is no assurance that additional patents will be issued [125]. Market and Economic Considerations - The company is monitoring potential changes in reimbursement and coverage policies from government and private payors, which could impact FIRDAPSE® sales [171]. - The company is assessing the impact of the Canadian Court's decision to overturn the approval of Ruzurgi® and its potential effects on FIRDAPSE® sales in the U.S. [171]. - The company is focused on the successful commercialization of FIRDAPSE® in Canada and is awaiting the outcome of appeals regarding Ruzurgi® [171]. - The company is closely monitoring the state of the economy and its potential impact on business operations [171]. Investment and Liquidity - The company emphasizes liquidity and preservation of principal in its investment activities, focusing on cash and short-term investments [174]. - The company does not use derivative financial instruments in its investment portfolio, prioritizing capital preservation [174]. - The company may require additional working capital depending on future success with FIRDAPSE® sales [159]. - The effective income tax rate increased to 24.2% for the three months ended March 31, 2022, from 22.5% in the same period of 2021 [154].
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
Financial Data and Key Metrics Changes - Catalyst Pharmaceuticals reported record Firdapse revenue of $35.9 million for Q3 2021, a 23% increase compared to Q3 2020 [6] - For the nine-month period, Firdapse revenues reached $99.7 million, up 13% year-over-year from $87.9 million [7] - Net income before income taxes for Q3 2021 was $14.1 million, a 20% increase from $11.7 million in Q3 2020 [7] - GAAP net income for Q3 2021 was $10.3 million, or $0.10 per share, compared to $43.3 million in Q3 2020, which included a one-time non-cash deferred tax asset [34] Business Line Data and Key Metrics Changes - Firdapse sales were driven by steady new patient enrollments and favorable reimbursement dynamics, with new patient enrollments up 26% year-over-year [21] - The company has reached approximately 800 adult LEMS patients since the launch of Firdapse, with a focus on expanding its reach to the remaining undiagnosed patients [22] Market Data and Key Metrics Changes - The company has only reached about 25% of the estimated 3,000 U.S. LEMS patients, indicating significant growth potential [10] - Approximately 50% of LEMS patients are thought to be tumor LEMS patients, primarily linked to small cell lung cancer, highlighting a key growth area for the company [23] Company Strategy and Development Direction - Catalyst is focused on expanding the label for Firdapse to include pediatric LEMS patients and is preparing a supplementary MDA submission for this purpose [27] - The company is also working on a long-acting formulation of Firdapse to improve patient experience and therapeutic consistency [26] - Catalyst has decided to end the MuskMG program to concentrate R&D efforts on more promising areas, indicating a strategic shift towards maximizing resource utilization [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued organic growth through the end of the year and beyond, despite challenges posed by the Delta variant of COVID-19 [7][19] - The company is well-prepared to ensure uninterrupted access to Firdapse for LEMS patients and is committed to addressing patient needs [12] Other Important Information - Catalyst ended the quarter with $174.8 million in cash and short-term investments, providing financial flexibility for future growth opportunities [8] - The company has made substantial investments in Firdapse and is focused on expanding its intellectual property portfolio, with two patents extending exclusivity to 2034 [13][31] Q&A Session Summary Question: What are the key growth drivers for Firdapse in 2022? - Management indicated that they may provide guidance in early Q1 2022 and highlighted the importance of increasing awareness and the breadth of prescribers as key growth factors [40][41] Question: Can you provide details on the pediatric filing for LEMS? - Management confirmed that pediatric LEMS is an autoimmune condition similar to adult LEMS, with an estimated 10 to 15 known cases, and emphasized the importance of ensuring treatment access for all patients [46][47] Question: What would be the impact if a competitor's product is pulled from the market? - Management expressed concern for a smooth transition for patients and indicated that they expect a significant influx of patients over a 30 to 60-day period if that event occurs [55][57] Question: What challenges have you faced in business development diligence? - Management noted that valuation was a significant challenge in their recent assessments, leading them to walk away from a potential acquisition due to discomfort with the valuation [62]