Full Press Release Details
Catalyst Pharmaceuticals Reports Record First Quarter 2025 Financial Results and Provides Business Update
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
of Between $545 Million and $565 Million
Strengthens 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 Held on May 8, 2025, at 8:30 AM ET
CORAL GABLES, Fla., - May 7, 2025 - Catalyst Pharmaceuticals, Inc. ( Catalyst or Company ) (Nasdaq: CPRX), today reported
financial results for the first quarter of 2025 and provided a business update.
Catalyst s exceptional first quarter performance underscores
the continued strength of our commercial strategy and the growing demand for our differentiated therapies, said Richard J. Daly, President and CEO of Catalyst. Our 43.6% year-over-year total revenue growth for the first quarter of 2025
is a testament to our focused execution and the increasing recognition of the value that our therapies deliver. Looking ahead, we see meaningful opportunities to further establish AGAMREE as a cornerstone therapy in the Duchenne muscular dystrophy
(DMD) market and expand FIRDAPSE s clinical utility in Lambert-Eaton myasthenic syndrome (LEMS), addressing a significant unmet need for patients in both markets. We continue to evaluate strategically aligned opportunities to strengthen our
portfolio and expand our reach to serve more patients. Building on our momentum, we are confident in our ability to execute our 2025 strategic priorities and drive long-term growth.
Financial Highlights
| For the Three Months Ended March 31, | 2025 | 2024 | % Change | |||||||||
| (In thousands, except per share data) | ||||||||||||
| Product Revenue, net | $ | 141,400 | $ | 98,441 | 43.6 | % | ||||||
| FIRDAPSE Product Revenue, net | $ | 83,731 | $ | 66,842 | 25.3 | % | ||||||
| FYCOMPA Product Revenue, net | $ | 35,627 | $ | 30,425 | 17.1 | % | ||||||
| AGAMREE Product Revenue, net* | $ | 22,042 | $ | 1,174 | 1,777.5 | % | ||||||
| GAAP Net Income | $ | 56,737 | $ | 23,275 | 143.8 | % | ||||||
| Non-GAAP Net Income ** | $ | 86,596 | $ | 46,767 | 85.2 | % | ||||||
| GAAP Net Income Per Share Basic | $ | 0.47 | $ | 0.20 | 135.0 | % |
| Non-GAAP Net Income Per Share Basic** | $ | 0.71 | $ | 0.40 | 77.5 | % | ||||||
| GAAP Net Income Per Share Diluted | $ | 0.45 | $ | 0.19 | 136.8 | % | ||||||
| Non-GAAP Net Income Per Share Diluted** | $ | 0.68 | $ | 0.38 | 78.9 | % | ||||||
| As of March 31, 2025 and December 31, 2024 | ||||||||||||
| (In thousands) | ||||||||||||
| Cash and Cash Equivalents | $ | 580,656 | $ | 517,553 | 12.2 | % |
First Quarter 2025 Financial Highlights
delivered record first quarter 2025 results, reflecting the continued strength of its commercial execution and the durability of its growth strategy.
Year-to-date 2025 Select Business Highlights
Catalyst continued to advance its strategic objectives in the first quarter of 2025, achieving key milestones across intellectual property and regulatory
2025 Financial Outlook Reaffirmed
reaffirming its full-year 2025 revenue outlook, reflecting confidence in its continued commercial execution and portfolio performance.
First Quarter 2025 Financial Results
sales: Cost of sales for the first quarter of 2025 was $17.9 million, compared to $12.5 million in the first quarter of 2024. As previously disclosed, royalties and milestone obligations related to AGAMREE are expected to increase if
full-year product revenue exceeds $100 million. Royalties for FYCOMPA will commence following the loss of market exclusivity in May 2025 and will be subject to tiered rates based on annual net sales and the timing of generic entry. Milestone
obligations are recorded when the obligation is incurred and capitalized over the remaining useful life of the asset.
Research and development
expenses: Research and development expenses for the first quarter of 2025 were $3.9 million, compared to $2.6 million in the first quarter of 2024. The Company anticipates full-year 2025 research and development
expenses to range between $15.0 million and $20.0 million, excluding the impact of any additional acquisitions, reflecting investments in the SUMMIT study and the start of initiatives to investigate the potential for AGAMREE s label
to be expanded in the future.
Selling, general, and administrative expenses: Selling, general, and administrative (SG&A)
expenses for the first quarter of both 2025 and 2024 were $46.9 million. SG&A expenses are expected to increase modestly over the remainder of the year, reflecting personnel additions during 2024 and the strategic realignment of
dedicated commercial teams supporting FIRDAPSE and AGAMREE which became effective at the start of the 2025 second quarter.
Amortization of intangible
assets: Amortization of intangible assets was $9.3 million for the first quarter of both 2025 and 2024.
Operating income for the first quarter of 2025 was $63.4 million, compared to $27.1 million in the first quarter of 2024, representing an increase of approximately 133.6%.
GAAP net income: GAAP net income for the first quarter of 2025 was $56.7 million ($0.47 per basic and $0.45 per diluted
share), compared to GAAP net income of $23.3 million ($0.20 per basic and $0.19 per diluted share) in the first quarter of 2024.
Non-GAAP net income: Non-GAAP net income for the first quarter of 2025 was $86.6 million ($0.71 per basic and $0.68 per diluted share),
compared to non-GAAP net income of $46.8 million ($0.40 per basic and $0.38 per diluted share) in the first quarter of 2024. Non-GAAP net income for all
periods excludes from net income stock-based compensation, depreciation, amortization of intangible assets, and the income tax provision.
rate: The Company s effective income tax rate was 20.4% and 20.0% for the three months ended March 31, 2025 and 2024, respectively. Differences in the effective tax and the statutory federal income tax rate of 21% are driven by
state income taxes, fluctuations in the value of investments, and anticipated annual permanent differences offset by equity compensation deductions.
Cash and cash equivalents: Cash and cash equivalents were $580.7 million as of March 31, 2025.
Our Form 10-Q for the first quarter of 2025, filed with the U.S. Securities and Exchange
Commission on May 7, 2025, provides more detailed financial information and analysis of our financial condition and results of operations.
Conference Call & Webcast Details
| Date: | May 8, 2025 | |||
| Time: | 8:30 AM ET | |||
| US/Canada Dial-in Number: | (833) 316-2483 | |||
| International Dial-in Number: | (785) 838-9284 |
The webcast will be accessible under the Investors section on the Company s website
at www.catalystpharma.com. A webcast replay will be available on Catalyst s website for at least 30 days following the date of the event.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals,
Inc. (Nasdaq: CPRX) is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on
in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a
comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence while actively seeking to expand its global commercial footprint through strategic
agreements. Catalyst, headquartered in Coral Gables, Fla., was 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.
For more information, please visit
Catalyst s website at www.catalystpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking
statements involve known and unknown risks and uncertainties, which may cause Catalyst s actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Catalyst s revenue
forecasts for 2025 that are included in this press release will prove to be accurate, (ii) whether Catalyst will continue to be profitable and cash flow positive in 2025 and beyond, (iii) whether Catalyst will complete any acquisitions of
additional products, and the timing of any such acquisitions, (iv) the impact of the pending Paragraph IV litigation relating to FIRDAPSE if the results of these litigation matters are adverse, and (v) those factors described in
Catalyst s Annual Report on Form 10-K for the 2024 fiscal year, Catalyst s Quarterly Report on Form 10-Q for the first quarter of 2025, and its subsequent
filings with the U.S. Securities and Exchange Commission ( SEC ), could adversely affect Catalyst. Copies of Catalyst s filings with the SEC are available from the SEC, may be found on Catalyst s website, or may be obtained upon
request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
CATALYST PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
(in thousands, except share and per share data)
| For the Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ | 141,400 | $ | 98,441 | ||||
| License and other revenue | 21 | 68 | ||||||
| Total revenues | 141,421 | 98,509 | ||||||
| Operating costs and expenses: | ||||||||
| Cost of sales (a) | 17,911 | 12,520 | ||||||
| Research and development | 3,887 | 2,581 | ||||||
| Selling, general and administrative (a) | 46,911 | 46,938 | ||||||
| Amortization of intangible assets | 9,345 | 9,344 | ||||||
| Total operating costs and expenses | 78,054 | 71,383 | ||||||
| Operating income | 63,367 | 27,126 | ||||||
| Other income, net | 7,919 | 1,963 | ||||||
| Net income before income taxes | 71,286 | 29,089 | ||||||
| Income tax provision | 14,549 | 5,814 | ||||||
| Net income | $ | 56,737 | $ | 23,275 | ||||
| Net income per share: | ||||||||
| Basic | $ | 0.47 | $ | 0.20 | ||||
| Diluted | $ | 0.45 | $ | 0.19 | ||||
| Weighted average shares outstanding: | ||||||||
| Basic | 121,472,468 | 116,806,117 | ||||||
| Diluted | 126,957,982 | 123,403,626 |
CATALYST PHARMACEUTICALS, INC.
RECONCILIATION OF NON-GAAP METRICS (unaudited)
(in thousands, except share and per share data)
| For the Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| GAAP net income | $ | 56,737 | $ | 23,275 | ||||
| Non-GAAP adjustments: | ||||||||
| Stock-based compensation expense | 5,850 | 8,248 | ||||||
| Depreciation | 115 | 86 | ||||||
| Amortization of intangible assets | 9,345 | 9,344 | ||||||
| Income tax provision | 14,549 | 5,814 | ||||||
| Non-GAAP net income | $ | 86,596 | $ | 46,767 | ||||
| Non-GAAP net income per share: | ||||||||
| Basic | $ | 0.71 | $ | 0.40 | ||||
| Diluted | $ | 0.68 | $ | 0.38 | ||||
| Weighted average shares outstanding: | ||||||||
| Basic | 121,472,468 | 116,806,117 | ||||||
| Diluted | 126,957,982 | 123,403,626 |
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, 2025 | December 31, 2024 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 580,656 | $ | 517,553 | ||||
| Accounts receivable, net | 71,265 | 65,476 | ||||||
| Inventory | 19,778 | 19,541 | ||||||
| Prepaid expenses and other current assets | 14,019 | 21,039 | ||||||
| Total current assets | 685,718 | 623,609 | ||||||
| Operating lease right-of-use asset, net | 2,158 | 2,230 | ||||||
| Property and equipment, net | 1,239 | 1,354 | ||||||
| License and acquired intangibles, net | 147,327 | 156,672 | ||||||
| Deferred tax assets, net | 48,222 | 45,982 | ||||||
| Investment in equity securities | 24,208 | 21,564 | ||||||
| Total assets | $ | 908,872 | $ | 851,411 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 11,197 | $ | 16,593 | ||||
| Accrued expenses and other liabilities | 100,452 | 104,085 | ||||||
| Total current liabilities | 111,649 | 120,678 | ||||||
| Operating lease liability, net of current portion | 2,681 | 2,786 | ||||||
| Other non-current liabilities | 259 | 315 | ||||||
| Total liabilities | 114,589 | 123,779 | ||||||
| Total stockholders equity | 794,283 | 727,632 | ||||||
| Total liabilities and stockholders equity | $ | 908,872 | $ | 851,411 |
Source: Catalyst Pharmaceuticals, Inc.
Contact information:
Mary Coleman, Catalyst Pharmaceuticals,
David Schull, Russo Partners