Full Press Release Details
Catalyst Pharmaceuticals Reports Record Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Full Year 2024 Total Revenues of $491.7 Million, Marking Another Year of Record Growth
Full Year 2024 Total Revenues Grew 23.5% YoY, Driven by Strong Commercial Performance
Q4 2024 Net Product Revenue of $141.8 Million, Fueled by Sustained Organic Growth of
FIRDAPSE and Continued Market Adoption of AGAMREE
Pursuing Strategic Investments to Expand Market Presence and Accelerate Growth
Full Year 2025 Total Revenues Expected to be Between $545 Million and $565 Million, Reflecting Confidence in Continued Growth Momentum
Conference Call and Webcast to be Held on February 27, 2025, at 8:30 AM ET
CORAL GABLES, Fla., - February 26, 2025 - Catalyst Pharmaceuticals, Inc. ( Catalyst or Company ) (Nasdaq: CPRX) today
reported financial results for the fourth quarter and full year 2024 and provided a business update.
Our record 2024 performance is a reflection of
Catalyst s successful launch of AGAMREE and our continued outstanding commercial capabilities that fuel the momentum of our existing products, said Richard J. Daly, President and CEO of Catalyst. Achieving total revenues for 2024 of
$491.7 million demonstrates the strength of our scalable business model and the dedication of our teams to patient care. In 2025, we intend to not only seek to continue successfully growing our revenues from sales of our existing products,
but also to continue our robust business development efforts, our efforts to protect FIRDAPSE s intellectual property, and our efforts to increase the geographical availability of FIRDAPSE for LEMS patients.
Financial Highlights
| For the Years Ended December 31, | 2024 | 2023 | % Change | |||||||||
| ( in thousands, except per share data) | ||||||||||||
| Product Revenue, Net | $ | 489,327 | $ | 396,502 | 23.4 | % | ||||||
| FIRDAPSE Product Revenue, Net | $ | 306,035 | $ | 258,426 | 18.4 | % | ||||||
| FYCOMPA Product Revenue, Net | $ | 137,251 | $ | 138,076 | (0.6 | %) | ||||||
| AGAMREE Product Revenue, Net | $ | 46,041 | N/A | N/A | ||||||||
| GAAP Net Income | $ | 163,889 | $ | 71,410 | 129.5 | % | ||||||
| Non-GAAP Net Income** | $ | 276,288 | $ | 141,642 | 95.1 | % | ||||||
| GAAP Net Income Per Share Basic | $ | 1.38 | $ | 0.67 | 106.0 | % | ||||||
| Non-GAAP Net Income Per Share Basic** | $ | 2.33 | $ | 1.33 | 75.2 | % | ||||||
| GAAP Net Income Per Share Diluted | $ | 1.31 | $ | 0.63 | 107.9 | % | ||||||
| Non-GAAP Net Income Per Share Diluted** | $ | 2.21 | $ | 1.25 | 76.8 | % | ||||||
| Cash and Cash Equivalents (as of December 31) | $ | 517,553 | $ | 137,636 | 276.0 | % |
Beginning with the third quarter of 2024, Catalyst no longer includes acquisition in-process research and development
( IPR&D ) in its non-GAAP financial measures. Reported non-GAAP net income for the year ended December 31, 2023, included $81.5 million in
acquisition IPR&D relating to Catalyst s acquisition, during the third quarter of 2023, of the North American license for AGAMREE, which had not yet been approved by the U.S. Food and Drug Administration ( FDA ) at the time of the
acquisition. The commercialization was subsequently approved by the FDA during the fourth quarter of 2023. Prior period amounts have been revised to conform to the current period presentation. Catalyst has made this change to its presentation
following discussions with the Staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission.
Full Year 2024 Financial
Full year 2024 financial results underscore robust revenue expansion, supported by sustained organic momentum, a successful product
launch, and strong portfolio performance.
Fourth Quarter 2024 Financial Highlights:
Fourth-quarter 2024 financial performance was driven by ongoing organic product growth and the accelerating market uptake of AGAMREE.
2024 Commercial and Regulatory Highlights:
Notable Strategic Partnerships and Agreements:
2024 Industry Recognitions:
Fourth Quarter 2024 and Full Year 2024 Financial Results
Total revenues: Total revenues for the fourth quarter of 2024 were $141.8 million, compared to $110.6 million for the fourth
quarter of 2023, representing an increase of approximately 28.3% YoY. Full year 2024 total revenues were $491.7 million, compared to $398.2 million for full year 2023, representing an increase of approximately 23.5% YoY.
Product revenue, net: Product revenue, net for the fourth quarter of 2024, was $141.8 million, compared to $109.1 million for the
fourth quarter of 2023, representing an increase of approximately 30.0% YoY. Full year 2024 product revenue, net was $489.3 million, compared to $396.5 million for full year 2023, representing an increase of approximately 23.4%
Research and development expenses: In the fourth quarter of 2024, research and development
expenses were $3.8 million, compared to $2.0 million in the fourth quarter of 2023. Research and development expenses for full year 2024 were $12.6 million, compared to $93.2 million for full
year 2023, which included an $81.5 million IPR&D expense related to the acquisition of a North American license for AGAMREE in the third quarter of 2023.
Selling, general, and administrative expenses: Selling, general, and administrative expenses for the fourth quarter of 2024
were $44.2 million, compared to $42.0 million in the fourth quarter of 2023. Selling, general, and administrative expenses for full year 2024 were $177.7 million, compared to $133.7 million for full year
Amortization of intangible assets: Amortization of intangible assets was $9.3 million in the fourth quarter of 2024, compared
to $9.1 million in the fourth quarter of 2023. Amortization of intangible assets was $37.4 million in full year 2024, compared to $32.6 million for full year 2023.
Operating income: Operating income for the fourth quarter of 2024 was $62.8 million, compared to $41.7 million in the
fourth quarter of 2023, representing an increase of approximately 50.7%. Full year 2024 operating income was $195.1 million, compared to $86.8 million for full year 2023, representing an increase of approximately 124.8%.
GAAP net income: GAAP net income for the fourth quarter of 2024 was $55.9 million ($0.47 per basic
and $0.44 per diluted share), compared to GAAP net income of $34.8 million ($0.33 per basic and $0.31 per diluted share) for the fourth quarter of 2023. GAAP net income for full year 2024 was $163.9
million ($1.38 per basic and $1.31 per diluted share), compared to full year 2023 GAAP net income of $71.4 million ($0.67 per basic and $0.63 per diluted share).
Non-GAAP net income: Non-GAAP net income for the fourth quarter of
2024 was $88.8 million ($ 0.74 per basic and $0.70 per diluted share), compared to non-GAAP net income of $60.1 million ($0.56 per basic and $0.53 per diluted
share) for the fourth quarter of 2023. Non-GAAP net income for full year 2024 was $276.3 million ($2.33 per basic and $2.21 per diluted share), compared to full year 2023 non-GAAP net income of $141.6 million ($1.33 per basic and $1.25 per diluted share). Non-GAAP net income in all periods excludes from net income
stock-based compensation, depreciation, amortization of intangible assets, and the income tax provision.
equivalents: Cash and cash equivalents were $517.6 million as of December 31, 2024.
More detailed financial information
and analysis of our financial condition and results of operations can be found in our Annual Report on Form 10-K for fiscal year 2024, which was filed with the U.S. Securities and Exchange
Commission on February 26, 2025.
For full year 2025, the Company expects total revenues to be between $545 million and $565 million, reflecting continued growth in product revenue,
net from FIRDAPSE and AGAMREE.
The Company expects FIRDAPSE s product revenue, net for fiscal 2025 to range between $355 million
and $360 million. The Company anticipates an increase in Q1 2025 product revenue, net compared to Q1 2024 due to the temporary market dynamics following the Change Healthcare disruption in February 2024, which led to short-term shifts in
prescription fulfillment patterns. These effects are expected to normalize in Q2 2025, with revenue trends aligning with longer-term projections for the remainder of the year.
AGAMREE s product revenue, net for 2025 is expected to be between $100 million and $110 million, reflecting its continued market adoption and
commercial momentum. As a reminder, the Company commercially launched AGAMREE on March 13, 2024.
FYCOMPA s product revenue, net is forecasted
to be between $90 million and $95 million, driven by ongoing market demand ahead of the anticipated loss of patent exclusivity at the end of May 2025, for FYCOMPA tablets, and December 2025, for FYCOMPA oral suspension, with expected entry
of generic competition following each loss of exclusivity.
Cost of sales: AGAMREE royalties paid to the product licensor increase when AGAMREE
product revenue, net exceeds $100 million in any calendar year. Further, the Company will be required to make a $12.5 million milestone payment to the product licensor once AGAMREE product revenue for the calendar year reaches
$100 million. Further, the Company is required to pay royalties, based on net product revenue, to the product licensor for FYCOMPA following the loss of exclusivity.
Research and development expenses: Due to anticipated activities relating to the SUMMIT study and efforts seeking to begin the development of
additional indications for AGAMREE, the Company anticipates research and development expenses in 2025, absent another acquisition, to be between $15.0 and $20.0 million. Further, if the Company completes an acquisition, its R&D expenses may
become more significant.
Selling, general, and administrative expenses: The Company anticipates an increase in selling, general and
administrative expenses in 2025 compared to 2024, primarily driven by increased headcount, including full year costs for individuals hired throughout 2024 in certain functional areas to support the growth of its business and its overall strategy as
the Company focuses on expanding its product portfolio, including the separate commercial and medical field forces for FIRDAPSE and AGAMREE which is scheduled to commence at the beginning of the 2025 second quarter.
Tax rate: The Company anticipates that its effective tax rate will be relatively consistent for 2025 compared to 2024 and 2023.
Conference Call & Webcast Details
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 partnerships. 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 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
(in thousands, except share and per share data)
| (Unaudited) For the Three Months Ended December 31, | For the Years Ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Product revenue, net | $ | 141,809 | $ | 109,104 | $ | 489,327 | $ | 396,502 | ||||||||
| License and other revenue | 11 | 1,464 | 2,407 | 1,702 | ||||||||||||
| Total revenues | 141,820 | 110,568 | 491,734 | 398,204 | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of sales (a) | 21,643 | 15,809 | 68,845 | 51,967 | ||||||||||||
| Research and development | 3,798 | 1,972 | 12,648 | 93,150 | ||||||||||||
| Selling, general and administrative (a) | 44,192 | 42,036 | 177,740 | 133,710 | ||||||||||||
| Amortization of intangible assets | 9,344 | 9,059 | 37,377 | 32,565 | ||||||||||||
| Total operating costs and expenses | 78,977 | 68,876 | 296,610 | 311,392 | ||||||||||||
| Operating income | 62,843 | 41,692 | 195,124 | 86,812 | ||||||||||||
| Other income, net | 11,338 | 5,015 | 21,139 | 7,699 | ||||||||||||
| Net income before income taxes | 74,181 | 46,707 | 216,263 | 94,511 | ||||||||||||
| Income tax provision | 18,245 | 11,863 | 52,374 | 23,101 | ||||||||||||
| Net income | $ | 55,936 | $ | 34,844 | $ | 163,889 | $ | 71,410 | ||||||||
| Net income per share: | ||||||||||||||||
| Basic | $ | 0.47 | $ | 0.33 | $ | 1.38 | $ | 0.67 | ||||||||
| Diluted | $ | 0.44 | $ | 0.31 | $ | 1.31 | $ | 0.63 | ||||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 119,892,062 | 106,714,944 | 118,457,673 | 106,279,736 | ||||||||||||
| Diluted | 126,280,116 | 113,755,677 | 124,943,603 | 113,753,154 |
CATALYST PHARMACEUTICALS, INC.
RECONCILIATION OF NON-GAAP METRICS (unaudited)
(in thousands, except share and per share data)
| For the Three Months Ended December 31, | For the Years Ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| GAAP net income: | $ | 55,936 | $ | 34,844 | $ | 163,889 | $ | 71,410 | ||||||||
| Non-GAAP adjustments: | ||||||||||||||||
| Stock-based compensation expense | 5,171 | 4,250 | 22,251 | 14,250 | ||||||||||||
| Depreciation | 114 | 84 | 397 | 316 | ||||||||||||
| Amortization of intangible assets | 9,344 | 9,059 | 37,377 | 32,565 | ||||||||||||
| Income tax provision | 18,245 | 11,863 | 52,374 | 23,101 | ||||||||||||
| Non-GAAP net income | $ | 88,810 | $ | 60,100 | $ | 276,288 | $ | 141,642 | ||||||||
| Non-GAAP net income per share: | ||||||||||||||||
| Basic | $ | 0.74 | $ | 0.56 | $ | 2.33 | $ | 1.33 | ||||||||
| Diluted | $ | 0.70 | $ | 0.53 | $ | 2.21 | $ | 1.25 | ||||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 119,892,062 | 106,714,944 | 118,457,673 | 106,279,736 | ||||||||||||
| Diluted | 126,280,116 | 113,755,677 | 124,943,603 | 113,753,154 |
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS