Catalyst Pharmaceuticals Reports Positive Momentum in Second Quarter 2023
Reaffirms Full Year 2023 Total Revenue Guidance of Between
Forecasts FIRDAPSE® 2023 Net Product Revenue Guidance of Between
Forecasts FYCOMPA® 2023 Net Product Revenue of Approximately
Reaffirms Full Year 2023 Non-GAAP Net Income Forecast of Between
"As recently reported, the ongoing execution of our commercial strategy drove record results for the first quarter of this year as viewed against all metrics," said
Financial Guidance for Full Year 2023
The Company's 2023 financial guidance reflects considerations reported in its Form 10-Q filed on
- Full-year 2023 total revenues are forecasted to be in the range of between $375 million and $385 million, representing a 75% - 80% increase in total revenues as compared to 2022.
- FIRDAPSE® net product revenues for 2023 are forecasted to be between $245 million to $255 million, a 17% increase from the mid-point year over year.
- FYCOMPA® net product revenues for 2023 are forecasted to be approximately
$130million for approximately 11 months of sales. The Company's acquisition of this product closed on January 24, 2023.
- Cost of goods sold is expected to be approximately 13% of aggregate net product revenues.
- GAAP operating expenses are forecasted to be between
$175 millionand $185 millionin 2023. This includes (i) approximately $57 millionof expenses directly related to our FYCOMPA program, which includes approximately $10.3 millionfor one-time transition services fees ( $6.7 millionin Q1-2023 and estimated $3.6 millionin Q2-2023), and (ii) amortization of intangible assets of approximately $32 million(approximately $8.5 millionper quarter for the second, third and fourth quarter of 2023).
- GAAP net income before income tax for 2023 is forecasted to be between
$150 millionand $155 million.
- Non-GAAP net income for 2023 is forecasted to be between
$195 millionand $205 million.
This forecast does not account for the impact on the forecasted results of any future acquisition transactions that Catalyst may complete in 2023. Further, non-GAAP net income for 2023 excludes from GAAP net income stock-based compensation, depreciation, amortization, and income taxes. Finally, key guidance assumptions included in these projections reflect a continued recovery in macroeconomic and healthcare activity throughout 2023 and no change to the current COVID-19 environment.
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 flagship
For Full Prescribing and Safety Information for FIRDAPSE®, please visit www.firdapse.com. For Full Prescribing Information, including Boxed WARNING for FYCOMPA®, please visit www.FYCOMPA.com. For more information about
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) Catalyst's ability to successfully continue to sell its current products, (ii) Catalyst's ability to locate and acquire new product candidates through acquisition or in-licensing, (iii) Catalyst's ability to sell products acquired in the future that are already approved and to successfully develop any new product candidates acquired or in-licensed, (iv) whether Catalyst's forecasts of its financial results for 2023 will prove to be accurate, (v) whether Catalyst's patents will be sufficient to eliminate generic competition for FIRDAPSE® after Catalyst's orphan drug exclusivity for FIRDAPSE® for LEMS expires in late
Contact information: Investor Contact
Mary Coleman Catalyst Pharmaceuticals, Inc.(305) 420-3200 email@example.com Media Contact David Schull, Russo Partners(858) 717-2310 firstname.lastname@example.org
Source: Catalyst Pharmaceuticals, Inc.