Catalyst Enters 2025 With Strong Momentum; Reiterates Confidence in Full-Year Outlook Delivers Record Q1 2025 Total Revenues of $141.4 Million, a 43.6% YoY Increase FIRDAPSE® and AGAMREE® Drive Sustained Organic Growth, Underscoring Execution Strength Reaffirms Full-Year 2025 Total Revenue Guidance Provided Earlier This Year of Between $545 Million and $565 MillionStrengthens Balance Sheet with Cash and Cash Equivalents of $580.7 Million and No Debt as of March 31, 2025 Conference Call and Webcast to be He ...

Product Approvals and Launches - FIRDAPSE® received FDA approval for pediatric use, expanding the age range for treatment to include patients six years and older[165]. - AGAMREE® was launched in March 2024, with a strategic decision to split field forces for better product support effective April 1, 2025[167][168]. - Santhera's NDA for AGAMREE® was approved by the FDA on October 26, 2023, triggering a $36 million milestone payment[186]. - AGAMREE® was launched in the U.S. on March 13, 2024, for the treatment of DMD, with significant commercialization expenses incurred in Q1 2024[187]. - AGAMREE® has received marketing authorization in the EU for patients aged four and older, with a positive benefit-risk profile acknowledged by the CHMP[192]. Financial Performance - Total revenues for Q1 2025 were approximately $141.4 million, a 43.4% increase from $98.5 million in Q1 2024[227]. - FIRDAPSE® net sales increased by 25.3% to approximately $83.7 million in Q1 2025 from $66.8 million in Q1 2024[228]. - AGAMREE® net sales reached approximately $22.0 million in Q1 2025, compared to $1.2 million in the same period of 2024[228]. - Net income for the three months ended March 31, 2025, was approximately $56.7 million, a 143% increase from $23.3 million for the same period in 2024[244]. - Cash and cash equivalents increased to $580.7 million as of March 31, 2025, up from $517.6 million at December 31, 2024[245]. Research and Development - Research and development expenses for Q1 2025 were approximately $3.9 million, up 50.6% from $2.6 million in Q1 2024, representing 5% of total operating costs[235]. - Future research and development activities may increase as the company seeks to expand indications for FIRDAPSE® and AGAMREE®[236]. - The company is exploring the potential for additional indications for AGAMREE® and the ability to commercialize these indications[264]. Market Strategy and Expansion - The company is actively pursuing global expansion opportunities for FIRDAPSE®, particularly in Asia and Latin America[173]. - The company is exploring opportunities for portfolio expansion in rare disease products, focusing on licensing and asset acquisitions[209]. - The company entered into a license agreement with KYE for AGAMREE® in Canada, with KYE responsible for obtaining regulatory approval[196]. Regulatory and Compliance - The company is focused on successfully marketing and selling FIRDAPSE®, FYCOMPA®, and AGAMREE® while ensuring compliance with federal and state regulations[263]. - The company is monitoring the compliance of third-party suppliers and contract manufacturers with Good Manufacturing Practices (cGMP)[264]. Financial Obligations and Risks - The company anticipates a decline in FYCOMPA® product revenue after patent expiration on May 23, 2025, for tablets and December 15, 2025, for oral suspension[231]. - Ongoing patent litigation against generic manufacturers may affect the market entry of generic versions of FIRDAPSE®[180]. - The company is preparing for the loss of exclusivity for FYCOMPA®, expected to occur on or after May 23, 2025, for the tablet version[203]. - The company has sufficient funds to support operations for at least the next 12 months, but future profitability and funding availability are uncertain[247]. - The company may require additional working capital depending on the success of FIRDAPSE®, FYCOMPA®, and AGAMREE® sales[248]. Operational Costs - Selling, general and administrative expenses for Q1 2025 were approximately $46.9 million, consistent with $46.9 million in Q1 2024, representing 60% of total operating costs[237]. - Cost of sales for Q1 2025 was approximately $17.9 million, compared to $12.5 million in Q1 2024, primarily due to royalty payments[232]. - Amortization of intangible assets was approximately $9.3 million for both Q1 2025 and Q1 2024[233]. Other Financial Metrics - Other income for Q1 2025 was approximately $7.9 million, significantly higher than $2.0 million in Q1 2024, driven by increased interest income and gains on equity securities[240]. - Net cash provided by operating activities was $60.0 million for the three months ended March 31, 2025, compared to $31.9 million for the same period in 2024[251]. - Net cash provided by financing activities was $3.1 million for the three months ended March 31, 2025, down from $141.0 million in 2024[253]. Tax and Interest Rate Management - The effective income tax rate was approximately 20.4% for the three months ended March 31, 2025, compared to 20.0% for the same period in 2024[242]. - The company is managing interest rate risk primarily through investments in highly liquid money market funds and U.S. Treasuries[267].

Core Points - Catalyst Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on developing and commercializing novel medicines for patients with rare diseases [1][3] - The company will participate in the BofA Securities Health Care Conference 2025 on May 14, 2025, in Las Vegas, Nevada [1][2] - Catalyst has been recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies [3] Presentation Details - The presentation will take place on May 14, 2025, at 8:00 am PT [2] - A webcast of the presentation will be available on the company's website, with a replay accessible for at least 14 days [2] Company Overview - Catalyst Pharmaceuticals is committed to improving the lives of patients with rare diseases through innovative therapies and a comprehensive suite of support services [3] - The company maintains a strong U.S. presence and is actively seeking to expand its global commercial footprint through strategic partnerships [3]

Core Viewpoint - Catalyst Pharmaceuticals, Inc. will release its first quarter 2025 financial results on May 7, 2025, and will host a conference call and webcast on May 8, 2025, to discuss these results and provide a business update [1][2]. Company Overview - Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients with rare and difficult-to-treat diseases [4]. - The company has a proven track record of bringing life-changing treatments to market and prioritizes patient care through a comprehensive suite of support services [4]. - Catalyst is headquartered in Coral Gables, Florida, and has been recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies [4]. Conference Call & Webcast Details - The conference call and webcast will take place on May 8, 2025, at 8:30 AM ET [3]. - US/Canada dial-in number is (833) 316-2483, and the international dial-in number is (785) 838-9284 [3]. - The webcast will be accessible on the company's website, with a replay available for at least 30 days following the event [3].

CORAL GABLES, Fla., April 08, 2025 (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 reported that its sub-licensee in Canada, Kye Pharmaceuticals, Inc. (Kye), has announced that Health Canada has accepted the New Drug Submission (NDS) for AGAMREE®, a novel corticosteroid treatment ...

CORAL GABLES, Fla., April 08, 2025 (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 reported that its sub-licensee in Canada, Kye Pharmaceuticals, Inc. (Kye), has announced that Health Canada has accepted the New Drug Submission (NDS) for AGAMREE®, a novel corticosteroid treatment ...

Duchenne muscular dystrophy is a rare, debilitating and life-shortening neuromuscular disease1 Upon approval, vamorolone would be the first and only treatment option indicated for patients diagnosed with Duchenne muscular dystrophy in Canada The Canadian regulatory submission of vamorolone follows approvals in the US in 2023, and the European Union in early 2024 This New Drug Submission reflects Kye Pharmaceuticals' commitment to advancing treatments for rare diseases and serving the unmet needs of Canadia ...

It has been about a month since the last earnings report for Catalyst Pharmaceutical (CPRX) . Shares have added about 14.7% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is Catalyst due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers.How Have Estimates Been Moving Since T ...

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Company Overview - Catalyst Pharmaceutical (CPRX) shares increased by 6.2% to $25.74 in the last trading session, with a notable trading volume, and have gained 12.1% over the past four weeks [1] - The rise in stock price is linked to positive investor sentiment regarding the sales growth of Firdapse and Agamree, which are expected to drive growth for Catalyst in 2025 and beyond [2] Financial Performance - Catalyst is projected to report quarterly earnings of $0.54 per share, reflecting a year-over-year increase of 42.1% [2] - Expected revenues for the upcoming quarter are $131.07 million, representing a 33.1% increase from the same quarter last year [2] Earnings Estimate Revisions - The consensus EPS estimate for Catalyst has been revised 13.6% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook [4] Industry Comparison - Catalyst operates within the Zacks Medical - Drugs industry, where another company, Ironwood Pharmaceuticals (IRWD), saw a 5.7% increase in its stock price to $1.49, but has experienced a -22.3% return over the past month [4] - Ironwood's consensus EPS estimate has changed by -400% over the past month to -$0.01, although this reflects a 50% improvement from the previous year [5]