CORAL GABLES, Fla., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that it has been named on the BioSpace 2025 Best Places to Work. Catalyst is among 50 U.S. operating employers on the Best Places to Work list. The recipients are recognized as the most so ...

Catalyst Pharmaceuticals (CPRX) reported adjusted earnings of 57 cents per share for the third quarter of 2024, beating the Zacks Consensus Estimate of 49 cents. The company had incurred an adjusted loss of 24 cents in the year-ago quarter.Total revenues, the majority of which comprised product revenues, amounted to $128.7 million in the reported quarter, representing growth of 25.3% year over year. The recorded figure also surpassed the Zacks Consensus Estimate of $123 million.Catalyst’s top line primarily ...

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q3 2024 Earnings Conference Call November 7, 2024 8:30 AM ET Company Participants Richard Daly - President and Chief Executive Officer Michael Kalb - Chief Financial Officer Jeffrey Del Carmen - Chief Commercial Officer Steven Miller - Chief Operating Officer and Chief Scientific Officer Gary Ingenito - Chief Medical & Regulatory Officer Conference Call Participants Joon Lee - Truist Securities Charles Duncan - Cantor Fitzgerald Samantha Semenkow - Citi Investmen ...

Have you been paying attention to shares of Catalyst Pharmaceutical (CPRX) ? Shares have been on the move with the stock up 13.7% over the past month. The stock hit a new 52-week high of $23.12 in the previous session. Catalyst Pharmaceutical has gained 35.1% since the start of the year compared to the 3.2% move for the Zacks Medical sector and the -2.8% return for the Zacks Medical - Drugs industry.What's Driving the Outperformance?The stock has a great record of positive earnings surprises, as it hasn't m ...

For the quarter ended September 2024, Catalyst Pharmaceutical (CPRX) reported revenue of $128.7 million, up 25.3% over the same period last year. EPS came in at $0.57, compared to -$0.24 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $122.97 million, representing a surprise of +4.65%. The company delivered an EPS surprise of +16.33%, with the consensus EPS estimate being $0.49.While investors closely watch year-over-year changes in headline numbers -- revenue and ea ...

Catalyst Pharmaceutical (CPRX) came out with quarterly earnings of $0.57 per share, beating the Zacks Consensus Estimate of $0.49 per share. This compares to loss of $0.24 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 16.33%. A quarter ago, it was expected that this specialty drug company would post earnings of $0.42 per share when it actually produced earnings of $0.56, delivering a surprise of 33.33%.Over the last four qua ...

Reports Q3 2024 Total Revenues of $128.7 Million, Representing a 25.3% YoY Increase Record Revenues Driven by Continued Organic Growth in its Rare Disease Franchise Robust Financial Performance Highlights Operational Excellence and Strong Commercial Execution FIRDAPSE® Q3 2024 Net Product Revenues of $79.3 Million, Representing a 19.7% YoY Increase AGAMREE® Q3 2024 Net Product Revenues of $15.0 Million, Demonstrating Early U.S. Launch Success FYCOMPA® Q3 2024 Net Product Revenues of $32.1 Million Q3 2024 ...

Product Approvals and Launches - FIRDAPSE® received FDA approval for an increased maximum daily dosage from 80 mg to 100 mg, enhancing treatment flexibility for LEMS patients[83]. - The U.S. FDA approved AGAMREE® for treating DMD in patients aged two years and older, with a milestone payment of $36 million made to Santhera during Q4 2023[89]. - The U.S. commercial launch of AGAMREE® is scheduled for March 13, 2024, with substantial commercialization expenses incurred in preparation for the launch[89]. - KYE Pharmaceuticals is expected to file for regulatory approval of AGAMREE® in Canada in early 2025, with the company receiving an upfront payment and potential future royalties[90]. Financial Performance - Total revenues for the three and nine months ended September 30, 2024, were $128.7 million and $349.9 million, respectively, representing an increase of 25.4% and 21.7% compared to the same periods in 2023[104]. - FIRDAPSE® net sales increased by 19.7% to $79.3 million for the three months and by 18.5% to $223.5 million for the nine months ended September 30, 2024, compared to the same periods in 2023[104]. - Net income for the three and nine months ended September 30, 2024, was $43.9 million and $108.0 million, respectively, compared to a net loss of $30.8 million and a net income of $36.6 million in the same periods of 2023[117]. - The company reported net income of $108.0 million for the nine months ended September 30, 2024, an increase of $71.4 million compared to $36.6 million for the same period in 2023[120]. Expenses and Investments - Research and development expenses significantly decreased by approximately $80.4 million (96.1%) for the three months and $82.3 million (90.3%) for the nine months ended September 30, 2024, primarily due to the absence of the $81.5 million IPR&D purchase consideration from 2023[108][109]. - Selling, general and administrative expenses rose by approximately $12.3 million (36.7%) for the three months and $41.9 million (45.7%) for the nine months ended September 30, 2024, driven by increased employee compensation and commercialization expenses[110][111]. - The company incurred significant commercialization expenses for AGAMREE®, including sales and marketing, while only adding approximately 10 members to the commercial team[89]. - The company raised approximately $140.7 million from a public offering of 10 million shares of common stock completed on January 9, 2024[118]. Licensing and Royalties - The company reported a $160 million upfront payment for the acquisition of U.S. rights to FYCOMPA® and will pay royalties post-patent expiration[87]. - AGAMREE® License Agreement included a $75 million payment for exclusive North American rights to the investigational product candidate, vamorolone[88]. - The company recognized approximately $34.0 million in royalties payable under license agreements for FIRDAPSE®, compared to $27.7 million for the same period in 2023[121]. - The company recognized approximately $1.7 million and $2.7 million in royalties payable under the AGAMREE® license agreement for the three and nine months ended September 30, 2024, respectively[124]. Cash and Liquidity - The company has approximately $442.3 million in cash and cash equivalents as of September 30, 2024, sufficient to support operations for at least the next 12 months[92]. - As of September 30, 2024, the company had cash and cash equivalents of $442.3 million and working capital of $433.6 million, compared to $137.6 million and $143.3 million, respectively, at December 31, 2023[118]. - Net cash provided by operating activities for the nine months ended September 30, 2024, was $168.9 million, an increase from $88.0 million for the same period in 2023[120]. - The company emphasizes liquidity and preservation of principal in its investment activities, with exposure to interest rate risk confined to cash and cash equivalents[129]. Strategic Partnerships and Initiatives - The company is actively involved in partnerships with rare disease advocacy organizations to increase awareness and support for LEMS patients[85]. - The company is exploring partnerships and licensing opportunities to expand its rare neurology product portfolio, focusing on orphan CNS diseases[91]. - The company has established a joint steering committee with Santhera to oversee the lifecycle management and development of AGAMREE® for additional indications[89]. Market and Regulatory Considerations - The company faces uncertainties regarding the successful commercialization of AGAMREE®, FIRDAPSE®, and FYCOMPA® due to market dynamics and regulatory compliance[126]. - The company is evaluating the potential impact of transitioning DMD patients to gene therapy on AGAMREE® usage[127]. - The company is assessing whether the acquisition of the North American license for AGAMREE® will be accretive to EBITDA and EPS in 2024 and beyond[127]. - The company is focused on maintaining compliance with Good Manufacturing Practices (cGMP) through its third-party suppliers and contract manufacturers[127]. Patent and Legal Matters - Patent protection for FYCOMPA® includes two key patents expiring on May 23, 2025, and July 1, 2026, with ongoing litigation against ANDA filers[87]. - The company has initiated patent litigation against multiple generic drug manufacturers challenging FIRDAPSE® patents, with ongoing cases in federal court[85].

Investors with an interest in Medical - Drugs stocks have likely encountered both Catalyst Pharmaceutical (CPRX) and Stevanato Group (STVN) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look.We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. The Zacks Rank is a proven strategy that targets companies with positive earnings ...

Core Viewpoint - Catalyst Pharmaceuticals, Inc. is set to release its third quarter 2024 financial results on November 6, 2024, followed by a conference call on November 7, 2024, to discuss these results and provide a business update [1]. Company Overview - Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing treatments for rare diseases, with a commitment to improving patient lives [2]. - The company has a proven track record of bringing innovative therapies to market and emphasizes accessibility through comprehensive support services [2]. - Catalyst is headquartered in Coral Gables, Florida, and has been recognized as one of America's most successful small-cap companies by Forbes in 2024 [2].