Catalyst Pharmaceuticals Reports Preliminary Fourth Quarter and Full Year 2022 Total Revenues and Provides Full Year 2023 Revenue Guidance

2022 Total Revenues Estimated at $214 Million, Representing 52% YoY Growth

Forecast 2023 Total Revenues of Between $375 Million and $385 Million Including FYCOMPA(R) , Representing YoY Growth of 75% - 80%

2023 FIRDAPSE(R) Net Revenues Estimated at $245 Million to $255 Million

2023 FYCOMPA Net Revenues Estimated at $130 Million - 11 Months

FYCOMPA Business Unit Integration Expected to be Completed by Mid-Year 2023

Ended 2022 with Approximately $298 Million in Cash and Cash Equivalents

CORAL GABLES, Fla., Feb. 07, 2023 (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 2022 fourth quarter and full year total revenues estimates, a forecast of 2023 total revenue expectations, and a corporate update.

"2022 was an exceptional year for Catalyst, as we delivered record performance driven by consecutive quarterly revenue growth. The robust results capped an important year for our company, as we successfully executed our strategic initiatives across the business, adding further confidence in the long-term growth of the company," stated Patrick J. McEnany, Chairman and CEO of Catalyst. "We entered 2023 well positioned to capitalize on our expanded product portfolio, with a clear objective to fuel the continued growth of our highly complementary products, FIRDAPSE(R) and FYCOMPA(R) . We look forward to welcoming and onboarding to the Catalyst team many of the Eisai employees responsible for the success of the FYCOMPA epilepsy program. In doing so, we remain dedicated to serving our patient communities and enhancing access, as we leverage our proven competencies and our expanded U.S. presence in neuroscience. We expect to continue to deliver a sustained performance in 2023 and anticipate a meaningful increase in revenues as we build upon our momentum to maximize value for all our stakeholders. The Catalyst team is incredibly proud of what we accomplished in 2022 and excited about the prospects for the year ahead."

The information in this press release is based on preliminary unaudited information and management estimates for the full year 2022 and is subject to the completion of Catalyst's financial closing procedures. Catalyst expects to report its 2022 fourth quarter and full year results of operations on or about March 15, 2023.

CORPORATE HIGHLIGHTS

Preliminary Unaudited 2022 Fourth Quarter and Full Year Revenue and Year End Cash Position

Total 2022 Revenue

   -- Fourth quarter 2022 total revenues are estimated to be approximately $61        million, compared to total revenues of approximately $38 million in the        fourth quarter of 2021, representing an increase of approximately 61%        year-over-year.       -- Full year 2022 total revenues are estimated to be approximately $214        million, compared to total revenues of $141 million for 2021,        representing an increase of approximately 52% year-over-year. 

Total 2022 Cash and Investments

   -- Year end 2022 cash and cash equivalents are expected to be        approximately $298 million. 

2023 Financial Guidance

   -- The Company forecasts 2023 full year total revenues to be in the range        of between $375 million and $385 million, representing a range of between        75% - 80% increase in total revenues as compared to 2022.       -- FIRDAPSE net revenues for 2023 are forecasted to be between $245 million        to $255 million.       -- FYCOMPA net revenues for 2023 are forecasted to be $130 million for        approximately 11 months of sales. The Company's acquisition of this asset        closed on January 24, 2023. 

Key guidance assumptions included in these projections reflect a continued recovery in macroeconomic and healthcare activity throughout 2023 as it relates to the current COVID-19 environment.

2023 Strategic Priorities

   -- Sustain "patient first" commitment through established assistance        programs to all patients seeking access to treatment with FIRDAPSE for        LEMS and FYCOMPA for epilepsy.       -- Expect to complete the full integration of the FYCOMPA business unit by        mid-year. Currently extending offers to individuals on the Eisai teams        responsible for FYCOMPA sales, marketing, and medical affairs.       -- Continue to vigorously defend all our intellectual property rights.       -- Grow U.S. revenues for FIRDAPSE through awareness and education to        patients and healthcare professionals, with an expanded focus on        small-cell lung cancer patients who are comorbid with LEMS.       -- Capitalize on proven commercial capabilities to enhance the growth        potential of FYCOMPA, an established, first-in-class, commercial-stage        epilepsy asset.       -- Continue to leverage data from the FIRDAPSE NDA and additional data via        third-party relationships to further expand FIRDAPSE regulatory approvals        internationally, with current focus on Japan and potentially other        territories in Asia.       -- Continue to execute our focused strategic plan to expand and diversify        our rare disease neuroscience portfolio of product offerings and        late-stage pipeline opportunities to drive long-term sustainable growth.