Catalyst Pharmaceuticals Reports Record Third Quarter 2022 Financial Results and Provides a Corporate Update
Achieved Record Q3 2022 FIRDAPSE® Net Revenue of
Company Increases Full Year 2022 Total Revenue Guidance to
Q3 2022 GAAP Net Income of
Cash and Short-Term Investments Increased in Q3 2022 by
Non-GAAP Net Income for Q3 2022 of
Company to Host a Conference Call and Webcast on
"Catalyst delivered another solid quarter driven by record net revenues that exceeded expectations, marking this as another strong quarter of sequential growth of our FIRDAPSE® brand. These results reflect our exceptional commercial execution and continued commitment to the patient community that we serve," said
McEnany continued, "During the quarter, our priorities continued to be focused on commercial execution, preparing for the launch of our thoracic oncology programs to reach small-cell lung cancer patients with LEMS and diversifying our product portfolio with the acquisition of innovative therapies that address unmet medical needs in rare diseases. Moving ahead, we are well positioned to continue to drive organic growth as we look to strengthen our business with strategic opportunities that translate into added long-term value creation for all of our stakeholders."
RECENT BUSINESS HIGHLIGHTS
- Achieved all-time high net FIRDAPSE® product revenue of
$57.2 million for Q3 2022, representing robust growth of 59.3% year-over-year increase and a 7.8% increase compared to Q2 2022. - In
July 2022 , completed the acquisition of Ruzurgi®, including the acquisition of intellectual property and inventory and a license for commercial rights in theU.S. andMexico , which settledU.S. patent litigation and pending disputes in theU.S. betweenCatalyst andJacobus Pharmaceutical Company, Inc. - In
September 2022 , received FDA approval of the supplemental New Drug Application for FIRDAPSE®, expanding the indicated age range to include pediatric patients six years of age and older for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS"). - Enhanced intellectual property portfolio with an additional patent listed in the Orange Book with an expiry date of
February 25, 2037 , bringing the total number of U.S. patents listed to six. - Advanced Environmental, Social, and Governance ("ESG") initiatives through the launch of a comprehensive assessment of key ESG topics to identify appreciable targets for sustainability activities. Expect inaugural ESG Report in the first half of next year.
- On
September 15 th Catalyst was added to the S&P SmallCap 600 Index. For inclusion in the index, a stock must have a market cap that ranges from$850 million to$3.7 billion . - In the third quarter of 2022 we were ranked #39 in the 2022 Fortune 100 Fastest Growing Companies List.
- Recently awarded the BioFlorida 2022 "
David J. Gury Company of the Year” for the achievement of significant milestones and contributions to the growth ofFlorida's life science industry. - Advanced strategic growth initiatives to diversify our product portfolio with innovative therapies that address unmet needs in rare diseases.
Third Quarter 2022 Financial Results
Revenue: Product revenue, net in the third quarter of 2022, was
Research and development expenses: Research and development expenses in the third quarter of 2022 were
Selling, general, and administrative expenses: Selling, general, and administrative expenses for the third quarter of 2022 were
Operating income: Operating income for the third quarter of 2022 was
GAAP net income: GAAP net income for the third quarter of 2022 was
Non-GAAP Financial Measures
Non-GAAP1 net income for the third quarter of 2022 was
Cash and investments: Cash and investments were
Share repurchase program: The Company implemented a share repurchase program in
More detailed financial information and analysis regarding the Company's financial position at
2022 Financial Guidance: The Company has increased its forecast for the full year 2022 total revenues to be in the range of between
1 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 the 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 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 and amortization expense, and (iii) the provision for income taxes. Non-GAAP income per share is calculated by dividing non-GAAP income by the weighted average common shares outstanding.
Conference Call & Webcast Details
The Company will host a conference call and webcast on
International Dial-in Number: (862) 298-0702
A webcast and accompanying materials 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 following the date of the event.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, best-in-class medicines for rare diseases. Catalyst's New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration ("FDA") and FIRDAPSE® is commercially available in the United States as a treatment for adults and children ages six to seventeen with LEMS. 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.
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) the effect of the COVID-19 pandemic on Catalyst's business and results of operations, (ii) Catalyst's ability to locate and acquire new product candidates through acquisition or in-licensing, (iii) Catalyst's ability to sell products acquired that are already approved and to successfully develop any new product candidates acquired or in-licensed, (iv) whether Catalyst's total revenue, cash operating expense, and non-GAAP net income forecasts for 2022 will prove to be accurate, (v) whether Catalyst's patents listed in the Orange Book will be sufficient to eliminate generic competition for FIRDAPSE® after our orphan drug exclusivity for FIRDAPSE® for LEMS expires in late
Source:
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
(in thousands, except share data)
| For the Three Months Ended |
For the Nine Months Ended |
|||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Product revenue, net | $ | 57,173 | $ | 35,890 | $ | 153,255 | $ | 99,731 | ||||
| License and other revenue | 71 | 64 | 191 | 2,793 | ||||||||
| Total revenues | 57,244 | 35,954 | 153,446 | 102,524 | ||||||||
| Operating costs and expenses: | ||||||||||||
| Cost of sales | 9,665 | 5,310 | 23,198 | 14,536 | ||||||||
| Research and development | 8,310 | 4,487 | 15,696 | 11,944 | ||||||||
| Selling, general and administrative | 14,167 | 12,153 | 43,515 | 36,401 | ||||||||
| Total operating costs and expenses | 32,142 | 21,950 | 82,409 | 62,881 | ||||||||
| Operating income | 25,102 | 14,004 | 71,037 | 39,643 | ||||||||
| Other income (expense), net | 905 | 68 | 674 | 211 | ||||||||
| Net income before income taxes | 26,007 | 14,072 | 71,711 | 39,854 | ||||||||
| Income tax provision | 3,259 | 3,743 | 14,103 | 9,681 | ||||||||
| Net income | $ | 22,748 | $ | 10,329 | $ | 57,608 | $ | 30,173 | ||||
| Net income per share: | ||||||||||||
| Basic | $ | 0.22 | $ | 0.10 | $ | 0.56 | $ | 0.29 | ||||
| Diluted | $ | 0.20 | $ | 0.10 | $ | 0.52 | $ | 0.28 | ||||
| Weighted average shares outstanding: | ||||||||||||
| Basic | 103,318,572 | 103,196,550 | 102,967,280 | 103,470,762 | ||||||||
| Diluted | 111,986,025 | 107,843,196 | 110,352,214 | 107,476,175 | ||||||||
RECONCILIATION OF NON-GAAP METRICS (unaudited)
(in thousands, except share data)
| For the Three Months Ended |
For the Nine Months Ended |
||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||
| GAAP net income | $ | 22,748 | $ | 10,329 | $ | 57,608 | $ | 30,173 | |||||
| Non-GAAP adjustments: | |||||||||||||
| Stock-based compensation expense | 2,055 | 1,512 | 5,981 | 4,601 | |||||||||
| Depreciation | 35 | 31 | 106 | 159 | |||||||||
| Amortization | 518 | -- | 518 | -- | |||||||||
| Income tax provision | 3,259 | 3,743 | 14,103 | 9,681 | |||||||||
| Non-GAAP net income | $ | 28,615 | $ | 15,615 | $ | 78,316 | $ | 44,614 | |||||
| Non-GAAP net income per share: | |||||||||||||
| Basic | $ | 0.28 | $ | 0.15 | $ | 0.76 | $ | 0.43 | |||||
| Diluted | $ | 0.26 | $ | 0.14 | $ | 0.71 | $ | 0.42 | |||||
| Weighted average shares outstanding: | |||||||||||||
| Basic | 103,318,572 | 103,196,550 | 102,967,280 | 103,470,762 | |||||||||
| Diluted | 111,986,025 | 107,843,196 | 110,352,214 | 107,476,175 | |||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
2022 |
2021 |
||||
| (unaudited) | |||||
| ASSETS | |||||
| Current Assets: | |||||
| Cash and cash equivalents | $ | 256,065 | $ | 171,445 | |
| Short-term investments | -- | 19,821 | |||
| Accounts receivable, net | 9,337 | 6,619 | |||
| Inventory | 7,132 | 7,870 | |||
| Prepaid expenses and other current assets | 3,776 | 4,351 | |||
| Total current assets | 276,310 | 210,106 | |||
| Operating lease right-of-use asset | 2,833 | 3,017 | |||
| Property and equipment, net | 882 | 959 | |||
| License and acquired intangibles, net | 33,051 | -- | |||
| Deferred tax assets, net | 20,029 | 23,697 | |||
| Deposits | 9 | 9 | |||
| Total assets | $ | 333,114 | $ | 237,788 | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current Liabilities: | |||||
| Accounts payable | $ | 2,529 | $ | 2,768 | |
| Accrued expenses and other liabilities | 42,152 | 24,295 | |||
| Total current liabilities | 44,681 | 27,063 | |||
| Operating lease liability, net of current portion | 3,643 | 3,894 | |||
| Other non-current liabilities | 14,749 | -- | |||
| Total liabilities | 63,073 | 30,957 | |||
| Total stockholders’ equity | 270,041 | 206,831 | |||
| Total liabilities and stockholders’ equity | $ | 333,114 | $ | 237,788 | |
Contact information: Media ContactDavid Schull Russo Partners (858) 717-2310 david.schull@russopartnersllc.com Investor ContactMary Coleman Catalyst Pharmaceuticals , Inc. (305) 420-3200 mcoleman@catalystpharma.com
Source: Catalyst Pharmaceuticals, Inc.