Full Press Release Details
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 , Representing YoY Growth of 75% 80%
2023 FIRDAPSE Net Revenues Estimated at $245 Million to $255 Million
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. 7, 2023 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 and FYCOMPA . 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.
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
2022 Cash and Investments
2023 Financial Guidance
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
About Catalyst Pharmaceuticals
With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare neurological and epileptic diseases. Catalyst s U.S. commercial product portfolio consists of
FIRDAPSE (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome ( LEMS ) for adults and 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.
prescribing and safety information on FIRDAPSE, please visit www.firdapse.com, and for full prescribing and safety information on FYCOMPA, please visit www.fycompa.com. For more information about Catalyst Pharmaceuticals,
Inc., visit the Company s website at 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 successfully sell its current products, (iii) Catalyst s ability to locate and acquire new product candidates through acquisition or
in-licensing, (iv) Catalyst s ability to sell products acquired that are already approved and to successfully develop any new product candidates acquired or
in-licensed, (v) whether Catalyst s fourth quarter and full year 2022 total revenue forecast will prove to be accurate, (vi) whether Catalyst s total revenue forecast for 2023 and its net
revenue forecasts for FIRDAPSE and FYCOMPA for 2023 will prove to be accurate, (vii) whether Catalyst s patents listed in
the Orange Book will be sufficient to eliminate generic competition for FIRDAPSE after Catalyst s orphan drug exclusivity for FIRDAPSE for LEMS expires in late November 2025, (viii) whether legislative changes currently being considered
by Congress that are intended to reduce the cost of prescription drug products will adversely affect Catalyst, and (ix) those factors described in Catalyst s Annual Report on Form 10-K for
the 2021 fiscal year, Catalyst s Quarterly Report on Form 10-Q for the third quarter of 2022, 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.