Catalyst Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Catalyst Pharmaceuticals (CPRX) reported a 2021 revenue increase of 18% YoY, reaching $141 million. The fourth quarter saw revenues of $38 million, up 24% from 2020. Catalyst anticipates 2022 revenues between $195 million and $205 million, bolstered by orphan drug exclusivity for FIRDAPSE and new patent issuances extending exclusivity to 2034. Cash and investments stand at $191 million with no funded debt. The company is actively pursuing opportunities to diversify its portfolio and will host a conference call on March 17, 2022, for further updates.
- 2021 total revenues increased 18% YoY to $141 million.
- Strong fourth quarter revenue growth of 24% YoY.
- 2022 revenue guidance of $195 - $205 million, indicating a 38% - 45% increase.
- New patent issuances enhance FIRDAPSE exclusivity to 2034.
- GAAP net income for 2021 dropped to $39 million from $75 million in 2020.
- Fourth quarter GAAP net income decreased to $9 million from $11 million in the previous year.
Total 2021 Revenues Increased Approximately
Strong 2022 Revenue Growth Expected, Supported by FIRDAPSE® Orphan Drug Exclusivity
New Patent Issuances Strengthens FIRDAPSE Long-Term Commercial Potential to 2034
Actively Pursuing Opportunities to Diversify Commercial and Development Portfolio
Strong Cash and Investments Position of
Company to Host a Conference Call and Webcast on March 17, 2022, at 8:30 AM ET
CORAL GABLES, Fla., March 16, 2022 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today reported financial results for the fourth quarter and full year 2021 and provided a corporate update.
"We achieved strong financial performance during 2021, marked by our sustained focus on commercial and operational execution, which created a sizeable foundation as we continue to execute on our business strategy and invest in our long-term growth," said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst. "We entered 2022 with great momentum, having received affirmation of the orphan drug exclusivity for FIRDAPSE coupled with the issuance of three new patents directed to the treatment of patients suffering from LEMS, further reinforcing and diversifying our existing patent exclusivity to 2034. These important milestones significantly reinforce the product's commercial durability and are defining inflection points supporting the Company's continued growth. We believe we are well-positioned to build upon our success and are optimistic about the future of the Company as we diligently pursue opportunities to diversify our commercial and development portfolio, which aligns with our core mission to deliver value to our patients, healthcare providers, and shareholders."
RECENT BUSINESS HIGHLIGHTS
- Received positive outcome from U.S. Courts reaffirming the orphan drug exclusivity for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS").
- Transition of LEMS patients previously treated with Ruzurgi® is occurring seamlessly through Catalyst Pathway's differentiated "patient first" product access support program, established for all patients seeking access to FIRDAPSE for LEMS treatment.
- Sustained U.S. product revenue growth through enhanced awareness and education to patients and healthcare professionals, including our focus on paraneoplastic LEMS and oncology.
- Anticipate submission of a supplemental New Drug Application ("sNDA") to the U.S. Food and Drug Administration ("FDA") to support the approved use of FIRDAPSE for the treatment of pediatric LEMS patients before the end of the first quarter.
- Further strengthened the long-term commercial potential of FIRDAPSE as a result of the issuance of three new patents covering additional patient amifampridine metabolizer types, further adding to its current U.S. patent exclusivity protection until 2034.
- Received favorable Canadian Federal Court ruling enforcing FIRDAPSE's Innovative Drug data protections, resulting in the setting aside of the approval of Ruzurgi®.
- Provided 2022 total revenue guidance of
$195 million -$205 million supported by U.S. market exclusivity and an enhanced intellectual property portfolio for FIRDAPSE. - Advanced global initiatives with the initiation of a Phase 3 registrational study by sub-licensee partner DyDo Pharma to evaluate the efficacy and safety of FIRDAPSE for the treatment of LEMS in Japan.
- Continued to advance strategic initiatives to acquire a differentiated portfolio of innovative products to treat rare diseases, with a goal of driving long-term sustainable growth.
- Partnered with rare disease patients and advocacy groups supporting the 2022 Global Rare Disease Day to help raise awareness and amplify patients' voices for the need for new treatments.
Fourth Quarter and Full Year 2021 Financial Results
Total revenues: Total revenue in the fourth quarter of 2021 was
Total product revenue, net: Total product revenue, net in the fourth quarter of 2021 was
Operating income: Operating income for the fourth quarter of 2021 was
Research and development expenses: In the fourth quarter of 2021, research and development expenses were
Selling, general, and administrative expenses: Selling, general, and administrative expenses for the fourth quarter of both 2021 and 2020 were
GAAP Net Income for the fourth quarter of 2021 was
Non-GAAP Financial Measures
Non-GAAP1 net income for the fourth quarter of 2021 was
Non-GAAP1 net income for the full year 2021 was
More detailed financial information and analysis can be found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which was filed with the Securities and Exchange Commission ("SEC") on March 16, 2022.
Cash and investments were
Share repurchase program: The Company implemented a share repurchase program in March 2021. As of December 31, 2021, the Company had repurchased 2.2 million shares of Catalyst common stock in the open market, at an average price of
2022 Financial Guidance: The Company forecasts 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) depreciation expense, and (iii) the (benefit) 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 Thursday, March 17, 2022, at 8:30 AM ET to discuss the financial results and provide a business update.
US/Canada Dial-in Number: | (877) 407-8912 |
International Dial-in Number: | (201) 689-8059 |
A webcast and accompanying materials will be accessible under the investor section on the Company's website at www.catalystpharma.com. A replay of the webcast 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 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.
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 continuing effect of the COVID-19 pandemic on Catalyst's net product revenues and net income, (ii) Catalyst's ability to locate and acquire new product candidates through acquisition or in-licensing, (iii) Catalyst's ability to successfully develop any new product candidates acquired or in-licensed, (iv) whether Catalyst's total revenue forecast for 2022 will prove to be accurate, and (v) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2021 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.
Source: Catalyst Pharmaceuticals, Inc.
Media Contact
David Schull
Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com
Investor Contact
Mary Coleman
Catalyst Pharmaceuticals, Inc.
(305) 420-3200
mcoleman@catalystpharma.com
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, | |||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||
Revenues: | ||||||||||||||
Product revenue, net | $ | 38,266 | $ | 30,882 | $ | 137,997 | $ | 118,790 | ||||||
License and other revenue | 43 | 133 | 2,836 | 283 | ||||||||||
Total revenues | 38,309 | 31,015 | 140,833 | 119,073 | ||||||||||
Operating costs and expenses: | ||||||||||||||
Cost of sales | 7,348 | 4,869 | 21,884 | 17,039 | ||||||||||
Research and development | 4,992 | 4,175 | 16,936 | 16,497 | ||||||||||
Selling, general and administrative | 13,227 | 13,353 | 49,628 | 44,234 | ||||||||||
Total operating costs and expenses | 25,567 | 22,397 | 88,448 | 77,770 | ||||||||||
Operating income | 12,742 | 8,618 | 52,385 | 41,303 | ||||||||||
Other income, net | 71 | 106 | 282 | 587 | ||||||||||
Net income before income taxes | 12,813 | 8,724 | 52,667 | 41,890 | ||||||||||
Income tax provision (benefit) | 3,504 | (2,713 | ) | 13,185 | (33,093 | ) | ||||||||
Net income | $ | 9,309 | $ | 11,437 | $ | 39,482 | $ | 74,983 | ||||||
Net income per share: | ||||||||||||||
Basic | $ | 0.09 | $ | 0.11 | $ | 0.38 | $ | 0.72 | ||||||
Diluted | $ | 0.09 | $ | 0.11 | $ | 0.37 | $ | 0.71 | ||||||
Weighted average shares outstanding: | ||||||||||||||
Basic | 103,108,077 | 103,694,845 | 103,379,349 | 103,512,913 | ||||||||||
Diluted | 108,956,513 | 105,838,449 | 107,795,585 | 106,242,273 |
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, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
GAAP net income | $ | 9,309 | $ | 11,437 | $ | 39,482 | $ | 74,983 | |||||||
Non-GAAP adjustments: | |||||||||||||||
Stock-based compensation expense | 1,472 | 1,469 | 6,073 | 6,261 | |||||||||||
Depreciation | 33 | 19 | 192 | 92 | |||||||||||
Income tax provision (benefit) | 3,504 | (2,713 | ) | 13,185 | (33,093 | ) | |||||||||
Non-GAAP net income | $ | 14,318 | $ | 10,212 | $ | 58,932 | $ | 48,243 |
Non-GAAP net income per share: | ||||||||||||||||||||
Basic | $ | 0.14 | $ | 0.10 | $ | 0.57 | $ | 0.47 | ||||||||||||
Diluted | $ | 0.13 | $ | 0.10 | $ | 0.55 | $ | 0.45 | ||||||||||||
Weighted average shares outstanding: | ||||||||||||||||||||
Basic | 103,108,077 | 103,694,845 | 103,379,349 | 103,512,913 | ||||||||||||||||
Diluted | 108,956,513 | 105,838,449 | 107,795,585 | 106,242,273 |
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
December 31, 2021 | December 31, 2020 | ||||
ASSETS | |||||
Current Assets: | |||||
Cash and cash equivalents | $ | 171,445 | $ | 130,237 | |
Short-term investments | 19,821 | 10,041 | |||
Accounts receivable, net | 6,619 | 5,987 | |||
Inventory | 7,870 | 4,651 | |||
Prepaid expenses and other current assets | 4,351 | 8,328 | |||
Total current assets | 210,106 | 159,244 | |||
Operating lease right-of-use asset | 3,017 | -- | |||
Property and equipment, net | 959 | 130 | |||
Deferred tax assets, net | 23,697 | 32,971 | |||
Deposits | 9 | 9 | |||
Total assets | $ | 237,788 | $ | 192,354 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
Current Liabilities: | |||||
Accounts payable | $ | 2,768 | $ | 4,256 | |
Accrued expenses and other liabilities | 24,295 | 18,500 | |||
Total current liabilities | 27,063 | 22,756 | |||
Operating lease liability, net of current portion | 3,894 | -- | |||
Total liabilities | 30,957 | 22,756 | |||
Total stockholders' equity | 206,831 | 169,598 | |||
Total liabilities and stockholders' equity | $ | 237,788 | $ | 192,354 |
FAQ
What were Catalyst Pharmaceuticals' total revenues for 2021?
What is the revenue guidance for Catalyst Pharmaceuticals in 2022?
How did Catalyst Pharmaceuticals perform in the fourth quarter of 2021?
What is the significance of the new patents issued for FIRDAPSE?