Catalyst Pharmaceuticals Reports Strong Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
- Record total revenues of $398.2 million for 2023, an 85.9% increase YoY.
- Record fourth quarter 2023 total revenues of $110.6 million, an 82.0% increase QoQ.
- Reported GAAP net income of $71.4 million for 2023.
- Achieved non-GAAP net income of $223.2 million for 2023.
- FDA approval of AGAMREE for Duchenne muscular dystrophy.
- Commercial launch of AGAMREE on track for Q1 2024.
- Full-year 2024 revenue guidance of $455 million to $475 million.
- Key executive appointments and strategic collaborations.
- Cash and cash equivalents of $137.6 million as of December 31, 2023.
- None.
Insights
The reported financial results of Catalyst Pharmaceuticals indicate a substantial year-over-year (YoY) revenue growth of 85.9%, with a significant increase in net product revenue. This growth trajectory is particularly notable for FIRDAPSE, a key product in their portfolio, which saw a 20.8% increase in revenue. However, it's important to note the decline in GAAP net income by 14.0% compared to the previous year, which may raise questions among stakeholders regarding the company's profitability amidst expansion.
From an investment perspective, the full-year 2024 revenue guidance suggests a positive outlook, projecting further growth. However, the increase in selling, general and administrative expenses and the potential impact on FYCOMPA net product revenue due to changes in variable consideration should be carefully assessed for their effect on future margins and profitability.
The cash and cash equivalents position shows a significant reduction from the previous year, which could be a point of concern for liquidity, although this may be offset by the recent common stock offering. Investors should weigh the potential for growth against these financial health indicators.
The neuroscience sector, particularly the market for orphan CNS treatments, is witnessing increased demand and innovation. Catalyst's strategic focus on this area, bolstered by the FDA approval of AGAMREE, positions the company to capitalize on this trend. The anticipated Q1 2024 commercial launch of AGAMREE is expected to open new revenue streams and strengthen the company's market presence.
Investors should consider the competitive landscape and the potential market share Catalyst could capture with its expanded portfolio. The company's strategic partnerships and intellectual property developments, such as the new U.S. patents for FIRDAPSE, enhance its competitive edge and may contribute to sustained growth.
The FDA approval of AGAMREE for Duchenne muscular dystrophy patients aged two years and older represents a significant milestone for Catalyst Pharmaceuticals, potentially addressing an unmet medical need. The orphan drug status of AGAMREE may afford certain financial incentives, including market exclusivity, which can have a positive impact on the company's financial performance.
However, the successful commercialization of AGAMREE will depend on the drug's market uptake, pricing strategy and reimbursement landscape. The long-term safety and quality of life study for AGAMREE will also be crucial for maintaining its market authorization and could influence the company's R&D expenses.
Achieved Record 2023 Total Revenues of
Achieved Record Fourth Quarter 2023 Total Revenues of
Reported 2023 GAAP Net Income of
Reported 2023 Non-GAAP Net Income of
Bolstered Neuroscience Commercial Portfolio with the FDA Approval of AGAMREE®
Commercial Launch of AGAMREE on Track for Q1 2024
Full Year 2024 Total Revenues Guidance of Between
Conference Call and Webcast to be Held on February 29, 2024, at 8:30 AM ET
CORAL GABLES, Fla., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX) today reported financial results for the fourth quarter and full year 2023 and provided a business update.
"In 2023, Catalyst delivered exceptional financial performance demonstrated by robust revenue growth, exceeding our full-year guidance. Our confidence for continued growth is strengthened by the outstanding execution of our strategic initiatives, expansion of our product portfolio, and a growing commercial presence in the U.S. neuroscience market," stated Richard J. Daly, CEO of Catalyst. "As we enter this year with compelling momentum, our commitment to execution and advancement of our initiatives, with a concentration on orphan CNS and other strategic adjacencies, remains resolute. With an imminent U.S. commercial launch for AGAMREE®, we are well poised to propel further growth. We eagerly anticipate making this innovative therapy available to eligible Duchenne muscular dystrophy patients. Coupled with our accomplishments, substantial cash reserves, and prudent financial management, we aim to further fuel our growth through strategic avenues that will deliver further value while upholding our steadfast commitment to serving our patient communities."
Financial Highlights
| For the Year Ended December 31, | 2023 | 2022 | % Change |
| (In thousands, except share data) | |||
| Net Product Revenue | |||
| FIRDAPSE® Net Product Revenue | |||
| FYCOMPA® Net Product Revenue | N/A | N/A | |
| GAAP Net Income | ( | ||
| Non-GAAP Net Income ** | |||
| GAAP Net Income Per Share - Basic | ( | ||
| Non-GAAP Net Income Per Share – Basic** | |||
| GAAP Net Income Per Share – Diluted | ( | ||
| Non-GAAP Net Income Per Share – Diluted** | |||
| As of December 31, | |||
| Cash and Cash Equivalents | ( | ||
**Statements made in this press release include non-GAAP financial measures. Such information is provided as additional information and not as an alternative to Catalyst's financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP). These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst's current financial performance. Catalyst believes that the non-GAAP financial measures presented in this press release provide investors and prospective investors with an alternative method for assessing Catalyst's operating results in a manner that Catalyst believes is focused on the performance of ongoing operations and provides a more consistent basis for comparison between periods. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP accounting. Further, non-GAAP measures of net income used by Catalyst may be different from and not directly comparable to similarly titled measures used by other companies.
The non-GAAP financial measure included in this press release excludes from the calculation of net income (i) the expense associated with non-cash stock-based compensation, (ii) non-cash depreciation expense, (iii) non-cash amortization of intangible assets expense, (iv) acquired in-process research & development costs, and (v) the provision for income taxes. Non-GAAP net income per share is calculated by dividing non-GAAP net income by the weighted average shares outstanding. See the “Reconciliation of Non-GAAP Metrics” table below.
Recent Business Highlights
- Achieved record total revenues of
$110.6 million for Q4 2023 and Full Year 2023 total revenues of$398.2 million , representing robust growth of82.0% compared to Q4 2022 (QoQ) and85.9% compared to Full Year 2022 (YoY), respectively. - Achieved record FIRDAPSE net product revenue of
$69.8 million for Q4 2023 and$258.4 million for the Full Year 2023, representing growth of15.0% compared to Q4 2022 and20.8% compared to Full Year 2022, respectively. - Achieved record FYCOMPA net product revenue of
$39.3 million for Q4 2023 and$138.1 million for the Full Year 2023. - Provided Full-Year 2024 total revenue guidance of between
$455 million and$475 million , reflecting net product revenue of approximately$295 million to$310 million for FIRDAPSE, AGAMREE net product revenue of approximately$25 million to$30 million and FYCOMPA net product revenue of approximately$130 million to$135 million . - Announced appointments of Dr. Steven Miller to Executive Vice President, Chief Operating and Scientific Officer, Jeffrey Del Carmen to Executive Vice President, Chief Commercial Officer, and newly appointed Michael Kalb as Executive Vice President, Chief Financial Officer.
- Bolstered the neuroscience franchise commercial portfolio with the FDA approval of AGAMREE for the treatment of Duchenne muscular dystrophy for patients aged two years and older.
- On track for the U.S. commercial launch of AGAMREE in the first quarter of 2024.
- Announced that collaboration partner, DyDo Pharma, Inc., reported that it submitted a New Drug Application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in December 2023, seeking marketing approval for FIRDAPSE (amifampridine), with the review period expected to be approximately nine months from the submission date.
- Strengthened FIRDAPSE intellectual property estate with two new U.S. patents issued covering methods of treating LEMS with FIRDAPSE under fasting and fed conditions of dosing.
- Completed a
$150.0 million common stock offering in January 2024 with net proceeds of approximately$140.1 million , to be used to fund the potential acquisition of new product candidates and for general corporate purposes. - Ranked on Forbes 2024 List of America's Most Successful Small-Cap Companies.
- Partnered with Sofie's Journey to bring focus on epilepsy at the 11th Annual Epilepsy Awareness and Education Expo.
Fourth Quarter 2023 and Full Year 2023 Financial Results
Total revenues: Total revenues in the fourth quarter of 2023 were
Product revenue, net: Product revenue, net in the fourth quarter of 2023, was
Research and development expenses: In the fourth quarter of 2023, research and development expenses were
Selling, general, and administrative expenses: Selling, general, and administrative expenses for the fourth quarter of 2023 were
Amortization of intangible Assets. Amortization of intangible assets was
Operating income: Operating income for the fourth quarter of 2023 was
GAAP net income: GAAP net income for the fourth quarter of 2023 was
Non-GAAP net income: Non-GAAP net income for the fourth quarter of 2023 was
Cash and cash equivalents: Cash and cash equivalents were
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 2023, which was filed with the U.S. Securities and Exchange Commission on February 28, 2024.
2024 Outlook
Product revenue, net: Bolstered by continued growth of FIRDAPSE and additional net product revenue from AGAMREE, which we expect to launch during the first quarter of 2024, we anticipate achieving total revenues in 2024 within the range of
Product revenue for FYCOMPA in 2024 will be affected by differences in variable consideration (gross-to-net) compared to 2023, when revenues were booked under Eisai’s cost arrangements with distributors and government authorities. Starting on January 1, 2024, all such costs are tied to arrangements between the Company and those distributors and government agencies, which costs are likely to be higher than Eisai’s costs, thereby increasing the gross-to-net deductions for FYCOMPA and correspondingly decreasing FYCOMPA net product revenue.
Research and development expenses: Due to the expected launch of the AGAMREE long-term safety and quality of life study, we anticipate research and development expenses in 2024 to approximate the amount that was incurred in 2022.
Selling, general, and administrative expenses: We anticipate a significant increase in selling, general and administrative expenses in 2024 due to the launch of AGAMREE and the accompanying support of three commercial products, compared to two in 2023.
Tax rate: We anticipate our effective tax rate to increase slightly for 2024.
Conference Call & Webcast Details
The Company will host a conference call and webcast on February 29, 2024, at 8:30 AM ET to discuss the financial results and provide a business update.
| U.S./Canada Dial-in Number: | (877) 407-8912 |
| International Dial-in Number: | (201) 689-8059 |
A webcast will be accessible under the investor section on the Company's website at www.catalystpharma.com. A webcast replay will be available on the Catalyst website for 30 days after the event.
About Catalyst Pharmaceuticals, Inc.
With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare and difficult to treat diseases. Catalyst's flagship U.S. commercial product is FIRDAPSE® (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS") for adults and for children ages six to seventeen. In January 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA® (perampanel) CIII, a prescription medicine approved in people with epilepsy aged four and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS. Finally, on July 18, 2023, Catalyst acquired an exclusive license for North America for AGAMREE® (vamorolone) oral suspension 40 mg/mL, a novel corticosteroid treatment for Duchenne Muscular Dystrophy. AGAMREE previously received FDA Orphan Drug and Fast Track designations and was approved by the FDA for commercialization in the U.S. on October 26, 2023.
For more information about Catalyst Pharmaceuticals, Inc., visit the Company's website at www.catalystpharma.com. For Full Prescribing and Safety Information for FIRDAPSE®, visit www.firdapse.com. For Full Prescribing Information, including Boxed WARNING for FYCOMPA®, please visit www.fycompa.com. For Full Prescribing Information for AGAMREE, please visit https://www.agamree.com/.
Forward-Looking Statements
This press release contains forward-looking statements. 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 AGAMREE can be successfully launched and whether that launch will occur in the first quarter of 2024, (ii) whether AGAMREE's commercialization will be successful and accretive to Catalyst, (iii) Catalyst's ability to continue to sell its current products, (iv) whether Catalyst will continue to be profitable and cash flow positive, (v) whether Catalyst's total revenues and net product revenue forecasts for 2024 will prove to be accurate, (vi) whether Catalyst will complete more acquisitions of products, and the timing of such acquisition; and (vii) those factors described in Catalyst's Annual Report on Form 10-K for the 2023 fiscal year, and Catalyst's other filings with the 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.
Source: Catalyst Pharmaceuticals, Inc.
| CATALYST PHARMACEUTICALS, INC. | |||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||
| (in thousands, except share data) | |||||||||||
| (Unaudited) For the Three Months Ended December 31, | For the Year Ended December 31, | ||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||
| Product revenue, net | $ | 109,104 | $ | 60,683 | $ | 396,502 | $ | 213,938 | |||
| License and other revenue | 1,464 | 74 | 1,702 | 265 | |||||||
| Total revenues | 110,568 | 60,757 | 398,204 | 214,203 | |||||||
| Operating costs and expenses: | |||||||||||
| Cost of sales (a) | 15,809 | 11,195 | 51,967 | 34,393 | |||||||
| Research and development | 1,972 | 4,093 | 93,150 | 19,789 | |||||||
| Selling, general and administrative (a) | 42,036 | 14,088 | 133,710 | 57,085 | |||||||
| Amortization of intangible assets | 9,059 | 580 | 32,565 | 1,098 | |||||||
| Total operating costs and expenses | 68,876 | 29,956 | 311,392 | 112,365 | |||||||
| Operating income | 41,692 | 30,801 | 86,812 | 101,838 | |||||||
| Other income, net | 5,015 | 2,207 | 7,699 | 2,881 | |||||||
| Net income before income taxes | 46,707 | 33,008 | 94,511 | 104,719 | |||||||
| Income tax provision | 11,863 | 7,537 | 23,101 | 21,640 | |||||||
| Net income | $ | 34,844 | $ | 25,471 | $ | 71,410 | $ | 83,079 | |||
| Net income per share: | |||||||||||
| Basic | $ | 0.33 | $ | 0.24 | $ | 0.67 | $ | 0.80 | |||
| Diluted | $ | 0.31 | $ | 0.22 | $ | 0.63 | $ | 0.75 | |||
| Weighted average shares outstanding: | |||||||||||
| Basic | 106,714,944 | 104,583,296 | 106,279,736 | 103,374,606 | |||||||
| Diluted | 113,755,677 | 113,531,124 | 113,753,154 | 111,375,631 | |||||||
(a) exclusive of amortization of intangible assets
| CATALYST PHARMACEUTICALS, INC. | ||||||||||||||
| RECONCILIATION OF NON-GAAP METRICS (unaudited) | ||||||||||||||
| (in thousands, except share data) | ||||||||||||||
| For the Three Months Ended December 31, | For the Year Ended December 31, | |||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||
| GAAP net income: | $ | 34,844 | $ | 25,471 | $ | 71,410 | $ | 83,079 | ||||||
| Non-GAAP adjustments: | ||||||||||||||
| Stock-based compensation expense | 4,250 | 1,926 | 14,250 | 7,907 | ||||||||||
| Depreciation | 84 | 35 | 316 | 141 | ||||||||||
| Amortization of intangible assets | 9,059 | 580 | 32,565 | 1,098 | ||||||||||
| Income tax provision | 11,863 | 7,537 | 23,101 | 21,640 | ||||||||||
| In-process R&D | -- | -- | 81,513 | -- | ||||||||||
| Non-GAAP net income | $ | 60,100 | $ | 35,549 | $ | 223,155 | $ | 113,865 | ||||||
Non-GAAP net income per share: | ||||||||||||||
| Basic | $ | 0.56 | $ | 0.34 | $ | 2.10 | $ | 1.10 | ||||||
| Diluted | $ | 0.53 | $ | 0.31 | $ | 1.96 | $ | 1.02 | ||||||
| Weighted average shares outstanding: | ||||||||||||||
| Basic | 106,714,944 | 104,583,296 | 106,279,736 | 103,374,606 | ||||||||||
| Diluted | 113,755,677 | 113,531,124 | 113,753,154 | 111,375,631 | ||||||||||
| CATALYST PHARMACEUTICALS, INC. | |||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
| (in thousands) | |||||
| December 31, 2023 | December 31, 2022 | ||||
| Assets | |||||
| Current Assets: | |||||
| Cash and cash equivalents | $ | 137,636 | $ | 298,395 | |
| Accounts receivable, net | 53,514 | 10,439 | |||
| Inventory | 15,644 | 6,805 | |||
| Prepaid expenses and other current assets | 12,535 | 5,167 | |||
| Total current assets | 219,329 | 320,806 | |||
| Operating lease right-of-use asset | 2,508 | 2,770 | |||
| Property and equipment, net | 1,195 | 847 | |||
| License and acquired intangibles, net | 194,049 | 32,471 | |||
| Deferred tax assets, net | 36,544 | 18,736 | |||
| Investment in equity securities | 16,489 | — | |||
| Total assets | $ | 470,114 | $ | 375,630 | |
| Liabilities and Stockholders’ Equity | |||||
| Current Liabilities: | |||||
| Accounts payable | $ | 14,795 | $ | 3,975 | |
| Accrued expenses and other liabilities | 61,268 | 53,613 | |||
| Total current liabilities | 76,063 | 57,588 | |||
| Operating lease liability, net of current portion | 3,188 | 3,557 | |||
| Other non-current liabilities | 2,982 | 14,064 | |||
| Total liabilities | 82,233 | 75,209 | |||
| Total stockholders’ equity | 387,881 | 300,421 | |||
| Total liabilities and stockholders’ equity | $ | 470,114 | $ | 375,630 | |
FAQ
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What is the significance of the FDA approval of AGAMREE for Catalyst Pharmaceuticals, Inc.?
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What key event is Catalyst Pharmaceuticals, Inc. on track for in Q1 2024?
