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].

Core Insights - Catalyst Pharmaceutical (CPRX) is currently viewed as a more attractive investment compared to Stevanato Group (STVN) for those seeking undervalued stocks [1][3][7] Valuation Metrics - CPRX has a forward P/E ratio of 11.45, significantly lower than STVN's forward P/E of 45.23, indicating a more favorable valuation for CPRX [5] - The PEG ratio for CPRX is 3.32, while STVN's PEG ratio is much higher at 10.28, suggesting that CPRX offers better growth potential relative to its price [5] - CPRX's P/B ratio stands at 4.26, compared to STVN's P/B of 5.42, further supporting the argument that CPRX is undervalued [6] Earnings Estimates - CPRX holds a Zacks Rank of 2 (Buy), indicating positive earnings estimate revisions, while STVN has a Zacks Rank of 4 (Sell), suggesting a less favorable earnings outlook [3][7] - The stronger estimate revision activity for CPRX compared to STVN reinforces the conclusion that CPRX is the superior option for value investors [7]

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].

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Core Points - Catalyst Pharmaceuticals, Inc. has donated $100,000 to the American Red Cross to support relief efforts for communities affected by Hurricane Helene [1][2] - The company emphasizes its commitment to the community, particularly during crises, and aims to help ensure essential resources reach those in need [2] - The American Red Cross has mobilized over 1,400 disaster responders across the Carolinas, Tennessee, Georgia, and Florida to provide shelter, meals, and comfort to families impacted by the hurricane [2] Company Overview - Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing therapies for rare diseases [4] - The company has a proven track record of bringing life-changing treatments to market and prioritizes patient care and accessibility [4] - Catalyst is headquartered in Coral Gables, FL, and has been recognized as one of America's most successful small-cap companies by Forbes in 2024 [4]

Here are five stocks added to the Zacks Rank #1 (Strong Buy) List today: Catalyst Pharmaceuticals (CPRX) : This commercial-stage biopharmaceutical company which is focused on the development and commercialization of therapies targeting rare and difficult-to-treat diseases, has seen the Zacks Consensus Estimate for its current year earnings increasing 9.7% over the last 60 days. HCI Group (HCI) : This company which is engaged in diverse business activities, including property and casualty insurance, informat ...

Investors interested in Medical - Drugs stocks are likely familiar with Catalyst Pharmaceutical (CPRX) and Stevanato Group (STVN) . But which of these two stocks is more attractive to value investors? We'll need to take a closer look to find out. There are plenty of strategies for discovering value stocks, but we have found that pairing a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system produces the best returns. The proven Zacks Rank puts an emphasis on earnings e ...

Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it. Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate revisions, etc. - ...