Full Press Release Details
Catalyst Pharmaceuticals Reports Solid First Quarter 2024 Financial Results and Provides Business Update
Achieved Total Q1 2024 Revenues of $98.5 Million, a 15.4% YoY Increase, Underscored by Exceptional Execution and Continued Demand for
FIRDAPSE Q1 2024 Net Product Revenues of $66.8
Million, a 16.2% YoY Increase
Robust Revenue Momentum for FIRDAPSE
Successfully Commenced the U.S. Launch of AGAMREE on March 13, 2024
Reported AGAMREE Q1 2024 Net Product Revenues of $1.2 Million for the
First Two Weeks of Commercial Availability
Early AGAMREE Launch
Indicators Highlight Promising Product Uptake Surpassing Initial Expectations
Q1 2024 GAAP Net Income of $23.3 Million, $0.19 Per
Q1 2024 Non-GAAP Net Income of $46.8 Million, $0.38 Per Share Diluted
Reaffirm Full Year 2024 Total Revenue Guidance Between $455 Million and $475 Million
Conference Call and Webcast to be Held on May 9, 2024, at 8:30 AM ET
CORAL GABLES, Fla., May 8, 2024 - Catalyst Pharmaceuticals, Inc. ( Catalyst or Company ) (Nasdaq: CPRX)
today reported financial results for the first quarter of 2024 and provided a business update.
Our strong performance in the first quarter provides
us with the momentum for continued growth throughout the year, stated Richard Daly, President and Chief Executive Officer of Catalyst. The successful U.S. launch of AGAMREE and sustained double-digit growth of FIRDAPSE are a testament to
our team s commitment to serving patients through innovative products and outstanding execution. Building on the positive indicators observed during the initial phase of AGAMREE s launch further strengthens our confidence for accelerated
growth of this critically important product.
Financial Highlights
| For the Three Months Ended March 31, | 2024 | 2023 | % Change | |||||||||
| ( In thousands, except per share data) | ||||||||||||
| Product Revenue, net | $ | 98,441 | $ | 85,304 | 15.4 | % | ||||||
| FIRDAPSE Product Revenue, net | $ | 66,842 | $ | 57,526 | 16.2 | % | ||||||
| FYCOMPA Product Revenue, net** | $ | 30,425 | $ | 27,778 | 9.5 | % | ||||||
| AGAMREE Product Revenue, net | $ | 1,174 | N/A | N/A | ||||||||
| GAAP Net Income | $ | 23,275 | $ | 29,568 | (21.3 | %) | ||||||
| Non-GAAP Net Income *** | $ | 46,767 | $ | 46,805 | (0.1 | %) | ||||||
| GAAP Net Income Per Share - Basic | $ | 0.20 | $ | 0.28 | (28.6 | %) | ||||||
| Non-GAAP Net Income Per Share Basic*** | $ | 0.40 | $ | 0.44 | (9.1 | %) | ||||||
| GAAP Net Income Per Share Diluted | $ | 0.19 | $ | 0.26 | (26.9 | %) | ||||||
| Non-GAAP Net Income Per Share Diluted*** | $ | 0.38 | $ | 0.41 | (7.3 | %) | ||||||
| As of March 31, 2024 and December 31, 2023 | ||||||||||||
| ( In thousands) | ||||||||||||
| Cash and Cash Equivalents | $ | 310,411 | $ | 137,636 | 125.5 | % |
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 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
First Quarter 2024 Financial Results
Total revenues: In the first quarter of 2024, total revenues were $98.5 million, compared to $85.4 million for the first quarter of
2023, representing an increase of approximately 15.4%.
Product revenue, net: Product revenue, net for the first quarter of 2024 was
$98.4 million, compared to $85.3 million for the first quarter of 2023, representing an increase of approximately 15.4%.
Research and development expenses: Research and development expenses for the first quarter of 2024
were $2.6 million, compared to $3.6 million for the first quarter of 2023, representing a decrease of approximately 27.5%.
Selling, general, and administrative expenses: Selling, general, and administrative expenses for the first quarter of 2024
were $46.9 million, compared to $29.7 million for the first quarter of 2023, representing an increase of approximately 57.9% primarily relating to preparation for the launch of AGAMREE.
Amortization of intangible assets: Amortization of intangible assets was $9.3 million in the first quarter of 2024, compared to $6.5 million
in the first quarter of 2023, representing an increase of approximately 43.1%.
Operating income: Operating income for the first quarter of
2024 was $27.1 million, compared to $35.6 million for the first quarter of 2023, representing a decrease of approximately 23.8%.
net income: GAAP net income for the first quarter of 2024 was $23.3 million ($0.20 per basic and $0.19 per diluted share), compared to GAAP net income of $29.6 million ($0.28 per basic and $0.26 per diluted share) for the first quarter
Non-GAAP net income: Non-GAAP net income for the first
quarter of 2024 was $46.8 million ($0.40 per basic and $0.38 per diluted share), compared to non-GAAP net income of $46.8 million ($0.44 per basic and $0.41 per diluted share) for the first quarter
Cash and cash equivalents: Cash and cash equivalents were $310.4 million as of March 31, 2024.
Our Form 10-Q for the first quarter of 2024, filed with the U.S. Securities and Exchange Commission on May 8,
2024, provides more detailed financial information and analysis of our financial condition and results of operations.
The Company will host a conference call and webcast on May 9, 2024, at 8:30 AM ET to discuss the financial results and provide a
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.
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. On July 18th, 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 26th, 2023. AGAMREE became available in the U.S. by prescription on March 13, 2024.
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 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 the launch of AGAMREE will surpass initial
expectations and exceed 2024 full-year revenue forecasts for sales of the product that were previously published by the Company (ii) whether AGAMREE s commercialization will ultimately be profitable, cash flow positive, and accretive to
Catalyst, (iii) Catalyst s ability to continue to successfully sell its current products, (iv) whether Catalyst will continue to be profitable and cash flow positive, (v) whether Catalyst s total revenue forecast for 2024
included in this press release will prove to be accurate, (vi) whether Catalyst will complete additional acquisitions of products, and the timing of any such acquisitions; (vii) the impact of pending Paragraph IV litigation relating to the
Company s FIRDAPSE and FYCOMPA products if the results of these litigation matters are adverse, and (viii) those factors
described in Catalyst s Annual Report on Form 10-K for the 2023 fiscal year, Catalyst s Quarterly Report on Form 10-Q for the first quarter of 2024, 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.
CATALYST PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
(in thousands, except share and per share data)
| For the Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ | 98,441 | $ | 85,304 | ||||
| License and other revenue | 68 | 62 | ||||||
| Total revenues | 98,509 | 85,366 | ||||||
| Operating costs and expenses: | ||||||||
| Cost of sales (a) | 12,520 | 9,946 | ||||||
| Research and development | 2,581 | 3,562 | ||||||
| Selling, general and administrative (a) | 46,938 | 29,718 | ||||||
| Amortization of intangible assets | 9,344 | 6,531 | ||||||
| Total operating costs and expenses | 71,383 | 49,757 | ||||||
| Operating income | 27,126 | 35,609 | ||||||
| Other income, net | 1,963 | 1,704 | ||||||
| Net income before income taxes | 29,089 | 37,313 | ||||||
| Income tax provision | 5,814 | 7,745 | ||||||
| Net income | $ | 23,275 | $ | 29,568 | ||||
| Net income per share: | ||||||||
| Basic | $ | 0.20 | $ | 0.28 | ||||
| Diluted | $ | 0.19 | $ | 0.26 | ||||
| Weighted average shares outstanding: | ||||||||
| Basic | 116,806,117 | 105,561,229 | ||||||
| Diluted | 123,403,626 | 113,986,129 |
CATALYST PHARMACEUTICALS, INC.
RECONCILIATION OF NON-GAAP METRICS (unaudited)
(in thousands, except share and per share data)
| For the Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| GAAP net income | $ | 23,275 | $ | 29,568 | ||||
| Non-GAAP adjustments: | ||||||||
| Stock-based compensation expense | 8,248 | 2,892 | ||||||
| Depreciation | 86 | 69 | ||||||
| Amortization of intangible assets | 9,344 | 6,531 | ||||||
| Income tax provision | 5,814 | 7,745 | ||||||
| Non-GAAP net income | $ | 46,767 | $ | 46,805 | ||||
| Non-GAAP net income per share: | ||||||||
| Basic | $ | 0.40 | $ | 0.44 | ||||
| Diluted | $ | 0.38 | $ | 0.41 | ||||
| Weighted average shares outstanding: | ||||||||
| Basic | 116,806,117 | 105,561,229 | ||||||
| Diluted | 123,403,626 | 113,986,129 |
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, 2024 | December 31, 2023 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 310,411 | $ | 137,636 | ||||
| Accounts receivable, net | 60,493 | 53,514 | ||||||
| Inventory | 19,953 | 15,644 | ||||||
| Prepaid expenses and other current assets | 13,745 | 12,535 | ||||||
| Total current assets | 404,602 | 219,329 | ||||||
| Operating lease right-of-use asset | 2,440 | 2,508 | ||||||
| Property and equipment, net | 1,308 | 1,195 | ||||||
| License and acquired intangibles, net | 184,705 | 194,049 | ||||||
| Deferred tax assets, net | 38,276 | 36,544 | ||||||
| Investment in equity securities | 15,345 | 16,489 | ||||||
| Total assets | $ | 646,676 | $ | 470,114 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 10,261 | $ | 14,795 | ||||
| Accrued expenses and other liabilities | 69,305 | 61,268 | ||||||
| Total current liabilities | 79,566 | 76,063 | ||||||
| Operating lease liability, net of current portion | 3,091 | 3,188 | ||||||
| Other non-current liabilities | 2,607 | 2,982 | ||||||
| Total liabilities | 85,264 | 82,233 | ||||||
| Total stockholders equity | 561,412 | 387,881 | ||||||
| Total liabilities and stockholders equity | $ | 646,676 | $ | 470,114 |
Source: Catalyst Pharmaceuticals, Inc.
Contact Information:
Mary Coleman, Catalyst Pharmaceuticals,
David Schull, Russo Partners