Catalyst Pharmaceutical (CPRX) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. The power of a ...

CORAL GABLES, Fla., Sept. 24, 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 diseases, today announced that its sub-licensee in Japan, DyDo Pharma, Inc., ("DyDo") has reported that the Ministry of Health, Labor and Welfare of Japan has approved DyDo's New Drug Application ("NDA") to commercialize FIRDAPSE® (amif ...

Ad hoc announcement pursuant to Art. 53 LR A conference call will be held on September 12, 2024, at 14:30 CEST / 13:30 BST / 08:30 EDT. Details are at the end of this news release. Revenue from contracts with customers of CHF 14.1 million (H1-2023: CHF 3.9 million) Operating result of CHF -17.7 million (H1-2023: CHF -20.3 million) and net result of CHF -15.3 million (H1-2023: CHF -23.3 million) AGAMREE® (vamorolone) launched in Germany and Austria as first European markets; North America partner has launche ...

Core Insights - Catalyst Pharmaceutical reported adjusted earnings of 56 cents per share for Q2 2024, exceeding the Zacks Consensus Estimate of 42 cents and showing growth from 53 cents in the same quarter last year [2] - Total revenues reached $122.7 million, a 23% year-over-year increase, surpassing the Zacks Consensus Estimate of $111.6 million [2] Revenue Breakdown - Firdapse sales amounted to $77.4 million, reflecting a 19.2% year-over-year growth and beating the Zacks Consensus Estimate of $72.5 million [3] - Fycompa generated net product revenues of $36.5 million, exceeding the Zacks Consensus Estimate of $33.2 million and showing a year-over-year growth of 5.7% [5] - Agamree, launched in March 2024, generated revenues of $8.7 million in its first full quarter, surpassing the Zacks Consensus Estimate of $6 million [7] Expense Overview - Research and development (R&D) expenses were $3 million, down 25% year-over-year [7] - Selling, general and administrative (SG&A) expenses totaled $40.7 million, up 43% from $28.4 million in the previous year, primarily due to the launch of Agamree [8] Financial Guidance - Catalyst expects total revenues for 2024 to be between $455 million and $475 million, with Firdapse revenues projected at $295 million to $310 million and Fycompa revenues between $130 million and $135 million [9][10] - The revenue guidance for Agamree has been increased to $35 million to $40 million from the previous range of $25 million to $30 million [10] Market Performance - Catalyst shares have increased by approximately 8.3% since the last earnings report, outperforming the S&P 500 [1] - The consensus estimate for Catalyst has shifted upward by 5.14% in the past month, indicating positive investor sentiment [11] Industry Context - Catalyst operates within the Zacks Medical - Drugs industry, where Corcept Therapeutics reported revenues of $163.8 million, a year-over-year increase of 39.1% [14]

Core Insights - Catalyst Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on developing and commercializing novel medicines for rare and difficult-to-treat diseases [1][3] - The company will participate in several upcoming investor conferences, including the Wells Fargo Healthcare Conference, H.C. Wainwright Global Investment Conference, and Cantor Global Healthcare Conference [2] Company Developments - Catalyst's flagship product, FIRDAPSE® (amifampridine) Tablets 10 mg, is approved for treating Lambert-Eaton myasthenic syndrome (LEMS) in patients aged 6 and older, with a recent FDA approval increasing the maximum daily dose to 100 mg for certain patients [3] - In January 2023, Catalyst acquired U.S. commercial rights to FYCOMPA® (perampanel), a medication for treating partial-onset seizures and primary generalized tonic-clonic seizures in patients aged 4 and older [4] - The company acquired an exclusive license for AGAMREE® (vamorolone), a treatment for Duchenne Muscular Dystrophy, which received FDA approval for commercialization in the U.S. on October 26, 2023, and became available by prescription on March 13, 2024 [5]

Catalyst Pharmaceutical (CPRX) closed the last trading session at $19.24, gaining 13.9% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $30.14 indicates a 56.7% upside potential. The average comprises seven short-term price targets ranging from a low of $26 to a high of $38, with a standard deviation of $3.89. While the lowest estimate indicates an increase of 35.1% from the curren ...

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. - ...

Financial Data and Key Metrics Changes - In Q2 2024, Catalyst Pharmaceuticals reported total revenues of $122.7 million, a 23.2% increase compared to Q2 2023, driven by strong organic growth from FIRDAPSEE and AGAMREE [4][12][19] - Net income before income taxes was $55.8 million, a 15% increase from $48.5 million in Q2 2023, with GAAP net income of $40.8 million or $0.33 per diluted share, an 8% year-over-year increase [19][20] - Non-GAAP net income for Q2 2024 was $69.6 million or $0.56 per diluted share, compared to $60.4 million or $0.53 per diluted share in Q2 2023 [20] Business Line Data and Key Metrics Changes - FIRDAPSEE achieved Q2 net sales of $77.4 million, a 19.2% increase year-over-year, attributed to steady new patient enrollments and a low discontinuation rate [13][14] - FYCOMPA generated Q2 net revenues of $36.5 million, with expectations for stable revenues in the second half of 2024 [15] - AGAMREE reported Q2 product net revenues of $8.7 million, exceeding initial launch expectations, with 46% of new enrollments transitioning from EMFLAZA [16][17] Market Data and Key Metrics Changes - The company received US approval for FIRDAPSEE's expanded maximum daily dose of 100 milligrams, enhancing treatment flexibility for healthcare professionals [6] - The ongoing collaboration with DyDo Pharma in Japan is expected to yield a NDA decision for FIRDAPSEE by the end of Q3 or early Q4 2024 [7] Company Strategy and Development Direction - The company is focused on a threefold growth strategy: outstanding execution, portfolio diversification, and targeted ex-US partnerships [10][11] - Catalyst aims to continue its buy and build plan, enhancing its capabilities in identifying and launching products that deliver value [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving total revenue at the upper end of the previously guided range of $455 million to $475 million for 2024, driven by strong performance across its product portfolio [5][19] - The company remains committed to advancing patient care and unlocking growth potential while maintaining a strong balance sheet [24] Other Important Information - The company ended Q2 2024 with cash and cash equivalents of $375.7 million, significantly up from $137.6 million at the end of 2023, driven by a capital raise and operational cash generation [22][23] - Research and development expenses decreased to $3 million in Q2 2024 from $4 million in Q2 2023, while SG&A expenses increased due to the launch of AGAMREE [22] Q&A Session Summary Question: Was there a bolus in AGAMREE sales due to pent-up demand? - Management confirmed significant pent-up demand leading to strong sales in Q2, with expectations for continued interest moving forward [25][26] Question: How will the new higher dose of FIRDAPSEE impact patient discontinuation rates? - Management does not expect an increase in discontinuation rates due to the new dosing flexibility, as the majority of discontinuations occur within the first six months of therapy [30][31] Question: What is the company's strategy for business development? - The company is focused on orphan and differentiated orphan products, with a broad approach to potential opportunities in the neuro space and beyond [31] Question: How is the patient mix for AGAMREE expected to evolve? - Management anticipates the patient mix will remain stable, with no significant impact from the generic entrance of EMFLAZA observed so far [34][36] Question: What is the status of ongoing litigation related to FIRDAPSEE? - Management is working diligently to resolve ongoing litigation favorably but refrained from commenting in detail [37] Question: What is the company's approach to future business development deals? - The company is inclined to pursue deals that enhance income diversity, with a preference for cash-funded deals initially, followed by potential leverage for larger transformational opportunities [39][40]

Catalyst Pharmaceuticals, Inc. (CPRX) reported adjusted earnings of 56 cents per share for the second quarter of 2024, beating the Zacks Consensus Estimate of 42 cents. The company reported adjusted earnings of 53 cents in the year-ago quarter. Total revenues, the majority of which comprised product revenues, amounted to $122.7 million in the reported quarter, representing growth of 23% year over year. The recorded figure also surpassed the Zacks Consensus Estimate of $111.6 million. Catalyst's top line pri ...

Core Insights - Catalyst Pharmaceutical (CPRX) reported $122.71 million in revenue for Q2 2024, a year-over-year increase of 23.2% [1] - The earnings per share (EPS) for the same period was $0.56, up from $0.33 a year ago, indicating a strong performance [1] - The reported revenue exceeded the Zacks Consensus Estimate of $111.76 million by 9.80%, and the EPS also surpassed the consensus estimate of $0.42 by 33.33% [1] Revenue Breakdown - Product revenue, net was $122.65 million, compared to the average estimate of $111.57 million from five analysts [3] - License and other revenue was $0.06 million, falling short of the average estimate of $0.32 million from three analysts [4] - FYCOMPA product revenue, net reached $36.54 million, exceeding the average estimate of $33.21 million from two analysts [5] - AGAMREE product revenue, net was $8.75 million, surpassing the average estimate of $5.98 million from two analysts [6] - FIRDAPSE product revenue, net totaled $77.37 million, compared to the average estimate of $72.53 million from two analysts [7] Stock Performance - Catalyst shares have returned +3.7% over the past month, contrasting with the Zacks S&P 500 composite's -5.9% change [7] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [7]