Full Press Release Details
Catalyst Pharmaceuticals Reports Preliminary Fourth Quarter and Full Year 2021 Total Revenues; Provides 2022 Total Revenue Guidance and Corporate Update
2021 Total Revenues Estimated at $141 Million, Representing 18% YoY Growth
Forecast 2022 Total Revenues of Between $195 Million and $205 Million, Representing YoY Growth of 38% to 45%
Recently Regained Orphan Drug Exclusivity in the U.S. for Amifampridine to Treat LEMS
Entering 2022 with a Strong Cash Position of Approximately $191 Million and No Funded Debt
Poised to Acquire Products, Pipeline and/or Companies in 2022
CORAL GABLES, Fla., Feb. 07, 2022 (GLOBE NEWSWIRE) Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage, patient-centric
biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today provided preliminary 2021 fourth quarter and full
year total revenue estimates, a forecast of 2022 total revenue expectations, and a corporate update.
2021 was a landmark year for Catalyst as we
achieved record revenues while attaining a significant milestone in upholding our Orphan Drug Exclusivity for FIRDAPSE for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). Our
strong performance is representative of our exceptional commercial, strategic, and operational capabilities, as well as our continued commitment to the patients we serve, said Patrick J. McEnany, Chairman and Chief Executive Officer
of Catalyst Pharmaceuticals. As a result of our accomplishments, we expect to realize a meaningful increase in 2022 revenues and look forward to building upon this momentum to fully maximize the value of FIRDAPSE. As we enter 2022, we
believe that our strong financial position will further empower us to execute on our strategic objectives to build a differentiated portfolio of products to drive long-term sustainable growth. We are excited about the year ahead as we remain
focused on executing on our near and longer-term initiatives.
RECENT EVENT - Conclusion of FDA Lawsuit
CORPORATE HIGHLIGHTS
information in this press release is based on preliminary unaudited information and management estimates for the full year 2021 and is subject to the completion of Catalyst s financial closing procedures. Catalyst expects to report its 2021
fourth quarter and full year results of operations on or about March 16, 2022.
Preliminary Unaudited 2021 Fourth Quarter and Full Year Financial
Total 2021 Cash and Investments
2022 Financial Guidance
Key guidance assumptions included in these projections reflect a continued recovery in macroeconomic and healthcare activity throughout
2022 as it relates to the current COVID-19 environment.
Catalyst Pharmaceuticals 2022 Strategic Priorities
About Catalyst Pharmaceuticals
Pharmaceuticals is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare
diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for rare diseases.
Catalyst s New Drug Application for FIRDAPSE (amifampridine) Tablets 10 mg for the treatment of adults with 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 (amifampridine) 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) Catalyst s ability to successfully develop and commercialize a long-acting formulation of FIRDAPSE, and (v) those factors described in
Catalyst s Annual Report on Form 10-K for the fiscal year 2020 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.