Catalyst Pharmaceuticals Reports Positive Momentum in Second Quarter 2023
01 Junho 2023 - 9:03AM
Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq:
CPRX) today reported positive momentum for the second quarter of
2023 and reaffirmed its full-year 2023 total revenue guidance of
between $375 million and $385 million, representing a 75% to 80%
increase in total revenues compared to 2022. The Company also
reaffirmed its forecast for the full year 2023 non-GAAP net income
to be between $195 million and $205 million. This guidance reflects
Catalyst's confidence in sustained organic revenue growth for
FIRDAPSE® combined with synergistic net product revenues derived
from sales of FYCOMPA®, a second commercial product for which the
Company acquired U.S. rights on January 24, 2023.
"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 Patrick J.
McEnany, Chairman and CEO of Catalyst. "As we advance into the
second quarter of 2023 with sustained momentum, we are on track to
meet our guidance which is supported by our exceptional financial
performance and strategic accomplishments. Given our recent
acquisition of FYCOMPA and the related increase in amortization
expenses of intangible assets, we believe that the non-GAAP
financial measures that we are currently providing in our financial
results press releases provide greater transparency and should
assist in better understanding and assessing Catalyst's business as
well as how we manage our business internally and set operational
goals. We believe the benefits from our diversified and
complementary product portfolio will continue to generate strong
free cash flow as we continue to advance on our growth initiatives
to drive sustainable growth and deliver value for our
shareholders."
Financial Guidance for Full Year
2023
The Company's 2023 financial guidance reflects
considerations reported in its Form 10-Q filed on May 10, 2023, as
well as its performance to date in the 2023 second quarter. Based
on these considerations, the Company believes that it is now in a
position to provide more detailed financial guidance for the full
year 2023 on both a GAAP and a non-GAAP basis.
- 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 $130 million 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 million and $185 million in 2023.
This includes (i) approximately $57 million of expenses directly
related to our FYCOMPA program, which includes approximately $10.3
million for one-time transition services fees ($6.7 million in
Q1-2023 and estimated $3.6 million in Q2-2023), and (ii)
amortization of intangible assets of approximately $32 million
(approximately $8.5 million per quarter for the second, third and
fourth quarter of 2023).
- GAAP net income before income tax
for 2023 is forecasted to be between $150 million and $155
million.
- Non-GAAP net income for 2023 is
forecasted to be between $195 million and $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.
About Catalyst
PharmaceuticalsWith 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 U.S. commercial product is
FIRDAPSE® (amifampridine) Tablets 10 mg, approved for the treatment
of Lambert-Eaton myasthenic syndrome ("LEMS") for adults and for
children ages six and up. 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. For additional information about the Company, please
visit www.catalystpharma.com.
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 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) 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
November 2025, (vi) whether legislative changes already made that
are intended to reduce the cost of prescription drug products and
any similar future legislative changes made by Congress will
adversely affect Catalyst, and (vii) those factors described in
Catalyst's Annual Report on Form 10-K for the 2022 fiscal year,
Catalyst's Quarterly Report on Form 10-Q for the first quarter of
2023, 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.
Contact information:
Investor Contact
Mary Coleman
Catalyst Pharmaceuticals, Inc.
(305) 420-3200
mcoleman@catalystpharma.com
Media Contact
David Schull, Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com
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