Full Press Release Details
Catalyst Pharmaceuticals Reports Record First Quarter 2023 Results, Achieving
98% Total Revenue Growth Year-over-Year
CORAL GABLES, Fla. - May 10, 2023 - Catalyst Pharmaceuticals,
Inc. ( Catalyst or the Company ) (Nasdaq: CPRX) today reported financial results for the first quarter of 2023 and provided a corporate update.
Catalyst had an excellent start to the year driven by the sustained organic growth of FIRDAPSE and compelling revenues from the newly acquired product, FYCOMPA . The acquisition of
FYCOMPA was strategically transformational, serving as a differentiating impetus and meaningful contributor to our company s long-term growth and exemplary revenue performance,
stated Patrick J. McEnany, Chairman and CEO of Catalyst. The integration of the FYCOMPA commercial and medical affairs teams is now broadly complete with a talented team that is fully trained and engaged. The seamless integration, coupled with
the strong quarterly revenue performance, is a testament to the exceptional execution capabilities of the entire Catalyst team.
Mr. McEnany continued: As significant progress is being made across all fronts, business development remains a high priority. Our
team continues to make substantial advancements through vigorous evaluation of a robust number of opportunities in pursuit of innovative assets that strategically align and complement our portfolio expansion approach. We remain confident that we are
well positioned to fully leverage our accomplishments and further deliver on key initiatives to enhance the long-term value for all of our stakeholders, with an ongoing commitment to our patient communities.
Financial Highlights (in Millions of U.S. dollars, except per share data, unaudited)
| For the Three Months Ended March 31, | 2023 | 2022 | % Change | |||||||||
| Total Revenues | $ | 85.4 | $ | 43.1 | 98 | % | ||||||
| FIRDAPSE Net Product Revenues | $ | 57.5 | $ | 43.0 | 34 | % | ||||||
| FYCOMPA Net Product Revenues* | $ | 27.8 | $ | 100 | % | |||||||
| GAAP Net Income** | $ | 29.6 | $ | 13.2 | 123 | % | ||||||
| Non-GAAP Net Income** | $ | 46.8 | $ | 19.4 | 141 | % | ||||||
| Earnings per share Diluted GAAP** | $ | 0.26 | $ | 0.12 | 117 | % | ||||||
| Earnings per share Diluted - Non-GAAP** | $ | 0.41 | $ | 0.18 | 128 | % |
Financial Results for First
Product Revenues, Net: Product revenues, net in the first quarter of 2023, were $85.3 Million, compared to $43.0
Million for the first quarter of 2022, representing an increase of 98% year-over-year.
Research and Development Expenses:
Research and development expenses in the first quarter of 2023 were $3.6 Million, compared to $3.4 Million in the first quarter of 2022.
Selling, General, and Administrative Expenses: Selling, general, and administrative expenses for the first quarter of 2023 were $29.7
Million, compared to $16.4 Million in the first quarter of 2022.
Amortization of Intangible Assets: Amortization of intangible
assets was $6.5 Million in the first quarter of 2023, compared to $0.00 in the first quarter of 2022. Intangible assets acquired subsequent to the first quarter of 2022 relate to the FYCOMPA
rights acquired in the first quarter of 2023 and the RUZURGI rights acquired in the third quarter of 2022.
Operating Income: Operating income for the first quarter of 2023 was $35.6 Million, compared to $17.4 Million in the first quarter of
2022, representing an increase of 105% year-over-year.
GAAP Net Income: GAAP net income for the first quarter of 2023 was $29.6
Million ($0.28 per basic share and $0.26 per diluted share), compared to $13.2 Million ($0.13 per basic share and $0.12 per diluted share) for the first quarter of 2022, representing a 123% increase YoY.
Non-GAAP Net Income1: Non-GAAP net income for the first quarter of 2023 was $46.8 Million ($0.44 per basic share and $0.41 per diluted share), compared to $19.4 Million ($0.19 per basic share and $0.18 per diluted share) for the first
quarter of 2022, representing a 132% increase YoY for each basic share and a 128% increase YoY for each diluted share.
Cash and Equivalents: Cash and equivalents were $148.2 Million as of March 31,
2023 Financial Guidance: The Company forecasts full-year 2023 total revenues, including FYCOMPA , to be between $375 Million and $385 Million, representing a 75% - 80% increase in total revenues compared to 2022. Key guidance assumptions in this forecast reflect a
continued recovery in macroeconomic and healthcare activity throughout 2023 related to the current COVID-19 environment.
More detailed financial information and analysis regarding the Company s financial position on March 31, 2023, and its results of
operations for the three months ended on that date can be found in the Company s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the U.S. Securities and Exchange
Commission ( SEC ) on March 10, 2023.
Conference Call & Webcast Details
The Company will host a conference call and webcast on Thursday, May 11, 2023, at 8:30 AM ET to discuss the financial results and provide
U.S./Canada Dial-in Number: (877)
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.
With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare neurological and epileptic 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 and up. 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. For additional information about the
Company, please visit www.catalystpharma.com.
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, and (iv) the provision for income taxes. Non-GAAP income per share is calculated by dividing non-GAAP income by the
weighted average common shares outstanding.
For Full Prescribing and Safety Information for FIRDAPSE , please visit www.firdapse.com. For Full Prescribing Information, including Boxed WARNING for FYCOMPA , please
visit www.fycompa.com. For more information about Catalyst Pharmaceuticals, Inc., visit the Company s website at www.catalystpharma.com.
Forward-Looking Statements
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) Catalyst s ability to successfully continue to sell its current products, (ii) Catalyst s ability to locate and acquire new product candidates through acquisition or
in-licensing, (iii) Catalyst s ability to sell products acquired in the future that are already approved and to successfully develop any new product candidates acquired or in-licensed, (iv) whether Catalyst s total revenue forecast for 2023 will prove to be accurate, (v) whether Catalyst s patents will be sufficient to eliminate generic competition for FIRDAPSE after Catalyst s orphan drug exclusivity for FIRDAPSE for LEMS expires in late November 2025, (vi) whether legislative changes
already made that are intended to reduce the cost of prescription drug products and any similar future legislative changes made by Congress will adversely affect Catalyst, and (vii) those factors described in Catalyst s Annual Report on
Form 10-K for the 2022 fiscal year and Catalyst s other 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 data)
| For the Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ | 85,304 | $ | 43,033 | ||||
| License and other revenue | 62 | 56 | ||||||
| Total revenues | 85,366 | 43,089 | ||||||
| Operating costs and expenses: | ||||||||
| Cost of sales (a) | 9,946 | 5,890 | ||||||
| Research and development | 3,562 | 3,403 | ||||||
| Selling, general and administrative (a) | 29,718 | 16,430 | ||||||
| Amortization of intangible assets | 6,531 | |||||||
| Total operating costs and expenses | 49,757 | 25,723 | ||||||
| Operating income | 35,609 | 17,366 | ||||||
| Other income, net | 1,704 | 93 | ||||||
| Net income before income taxes | 37,313 | 17,459 | ||||||
| Income tax provision | 7,745 | 4,218 | ||||||
| Net income | $ | 29,568 | $ | 13,241 | ||||
| Net income per share: | ||||||||
| Basic | $ | 0.28 | $ | 0.13 | ||||
| Diluted | $ | 0.26 | $ | 0.12 | ||||
| Weighted average shares outstanding: | ||||||||
| Basic | 105,561,229 | 102,781,771 | ||||||
| Diluted | 113,986,129 | 109,041,096 |
CATALYST PHARMACEUTICALS, INC.
RECONCILIATION OF NON-GAAP METRICS (unaudited)
(in thousands, except share data)
| For the Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| GAAP net income | $ | 29,568 | $ | 13,241 | ||||
| Non-GAAP adjustments: | ||||||||
| Stock-based compensation expense | 2,892 | 1,903 | ||||||
| Depreciation | 69 | 34 | ||||||
| Amortization of intangible assets | 6,531 | |||||||
| Income tax provision | 7,745 | 4,218 | ||||||
| Non-GAAP net income | $ | 46,805 | $ | 19,396 | ||||
| Non-GAAP net income per share: | ||||||||
| Basic | $ | 0.44 | $ | 0.19 | ||||
| Diluted | $ | 0.41 | $ | 0.18 | ||||
| Weighted average shares outstanding: | ||||||||
| Basic | 105,561,229 | 102,781,771 | ||||||
| Diluted | 113,986,129 | 109,041,096 |
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, 2023 | December 31, 2022 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 148,247 | $ | 298,395 | ||||
| Accounts receivable, net | 33,402 | 10,439 | ||||||
| Inventory | 10,328 | 6,805 | ||||||
| Prepaid expenses and other current assets | 6,934 | 5,167 | ||||||
| Total current assets | 198,911 | 320,806 | ||||||
| Operating lease right-of-use asset | 2,706 | 2,770 | ||||||
| Property and equipment, net | 1,285 | 847 | ||||||
| License and acquired intangibles, net | 184,083 | 32,471 | ||||||
| Deferred tax assets, net | 20,242 | 18,736 | ||||||
| Total assets | $ | 407,227 | $ | 375,630 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 3,391 | $ | 3,975 | ||||
| Accrued expenses and other liabilities | 53,318 | 53,613 | ||||||
| Total current liabilities | 56,709 | 57,588 | ||||||
| Operating lease liability, net of current portion | 3,468 | 3,557 | ||||||
| Other non-current liabilities | 13,389 | 14,064 | ||||||
| Total liabilities | 73,566 | 75,209 | ||||||
| Total stockholders equity | 333,661 | 300,421 | ||||||
| Total liabilities and stockholders equity | $ | 407,227 | $ | 375,630 |
Source: Catalyst Pharmaceuticals, Inc.
Contact information:
Pharmaceuticals, Inc.