Catalyst Pharmaceuticals, Inc. ("Catalyst or the Company")
(Nasdaq: CPRX) today reported financial results for the first
quarter of 2023 and provided a corporate update.
"Catalyst had an excellent start to the year
driven by the sustained organic growth of FIRDAPSE® and compelling
revenues from the newly acquired product, FYCOMPA®. The acquisition
of FYCOMPA® was strategically transformational, serving as a
differentiating impetus and meaningful contributor to our company's
long-term growth and exemplary revenue performance," stated Patrick
J. McEnany, Chairman and CEO of Catalyst. "The integration of the
FYCOMPA commercial and medical affairs teams is now broadly
complete with a talented team that is fully trained and engaged.
The seamless integration, coupled with the strong quarterly revenue
performance, is a testament to the exceptional execution
capabilities of the entire Catalyst team."
Mr. McEnany continued: "As significant progress
is being made across all fronts, business development remains a
high priority. Our team continues to make substantial advancements
through vigorous evaluation of a robust number of opportunities in
pursuit of innovative assets that strategically align and
complement our portfolio expansion approach. We remain confident
that we are well positioned to fully leverage our accomplishments
and further deliver on key initiatives to enhance the long-term
value for all of our stakeholders, with an ongoing commitment to
our patient communities."
Financial Highlights (in Millions of U.S. dollars,
except per share data, unaudited)
For the Three Months
Ended March 31, |
|
2023 |
|
|
|
2022 |
|
|
% Change |
|
|
|
|
Total Revenues |
$ |
85.4 |
|
|
$ |
43.1 |
|
|
|
98 |
% |
FIRDAPSE®Net Product
Revenues |
$ |
57.5 |
|
|
$ |
43.0 |
|
|
|
34 |
% |
FYCOMPA®Net Product
Revenues* |
$ |
27.8 |
|
|
$ |
- |
|
|
|
100 |
% |
|
|
|
|
GAAP Net Income** |
$ |
29.6 |
|
|
$ |
13.2 |
|
|
|
123 |
% |
Non-GAAP Net Income** |
$ |
46.8 |
|
|
$ |
19.4 |
|
|
|
141 |
% |
|
|
|
|
Earnings per share Diluted –
GAAP** |
$ |
0.26 |
|
|
$ |
0.12 |
|
|
|
117 |
% |
Earnings per share Diluted -
Non-GAAP** |
$ |
0.41 |
|
|
$ |
0.18 |
|
|
|
128 |
% |
___________________________________
*FYCOMPA® revenues are for the approximately 2
months that we owned the U.S. rights to the product.**Non-GAAP
financial measures refer to reconciliations of non-GAAP financial
measures to GAAP financial measures included in the accompanying
schedules. Non-GAAP financial measures exclude from GAAP financial
measures stock-based compensation, depreciation and amortization,
and income taxes. See the "Reconciliation of Non-GAAP Metrics"
table below.
BUSINESS HIGHLIGHTS
- Achieved all-time high total
revenues of $85.4 Million for Q1 2023, an 98% YoY increase and a
41% increase compared to Q4-2022, bolstered by the addition of
FYCOMPA® net product revenues.
- Completed the
FYCOMPA® acquisition; reported robust net product revenues of
$27.8 Million for the approximately two months following the close
of the product acquisition on January 24, 2023.
- Achieved Q1 2023 FIRDAPSE® net
product revenue of $57.5 Million, representing a substantial 34%
YoY increase.
- On track to achieve forecast total
revenues of between $375 Million and $385
Million.
- Completed a seamless U.S. FYCOMPA®
commercial team integration, with the full integration of
operations expected to be completed by the end of Q2 2023.
- Expect to file a supplemental New
Drug Application ("sNDA") to increase the maximum daily dosage of
FIRDAPSE® (amifampridine) from 80mg to 100mg for the treatment of
Lambert-Eaton myasthenic syndrome ("LEMS") early in the third
quarter of 2023.
- Anticipate FIRDAPSE® Phase 3 LEMS
registrational study completion in Japan by late 2023, and assuming
the study is successful, an expected NDA filing with the PMDA
(Pharmaceuticals and Medical Devices Agency) in the second quarter
of 2024 (by DyDo Pharma).
- Continue to vigorously pursue
innovative rare neurological assets in alignment with our portfolio
expansion strategy.
- Launched our inaugural
Environmental, Social, and Governance ("ESG") Report on May 1,
2023, highlighting the Company's ESG strategy, areas of focus, and
meaningful progress in key areas.
Financial Results for First Quarter 2023
Product Revenues, Net: Product
revenues, net in the first quarter of 2023, were $85.3 Million,
compared to $43.0 Million for the first quarter of 2022,
representing an increase of 98% year-over-year.
Research and Development
Expenses: Research and development expenses in the first
quarter of 2023 were $3.6 Million, compared to $3.4 Million in the
first quarter of 2022.
Selling, General, and Administrative
Expenses: Selling, general, and administrative expenses
for the first quarter of 2023 were $29.7 Million, compared to $16.4
Million in the first quarter of 2022.
Amortization of Intangible
Assets: Amortization of intangible assets was $6.5 Million
in the first quarter of 2023, compared to $0.00 in the first
quarter of 2022. Intangible assets acquired subsequent to the first
quarter of 2022 relate to the FYCOMPA® rights acquired in the first
quarter of 2023 and the RUZURGI® rights acquired in the third
quarter of 2022.
Operating Income: Operating
income for the first quarter of 2023 was $35.6 Million, compared to
$17.4 Million in the first quarter of 2022, representing an
increase of 105% year-over-year.
GAAP Net Income: GAAP net
income for the first quarter of 2023 was $29.6 Million ($0.28 per
basic share and $0.26 per diluted share), compared to $13.2 Million
($0.13 per basic share and $0.12 per diluted share) for the first
quarter of 2022, representing a 123% increase YoY.
Non-GAAP Net
Income1: Non-GAAP net income for the
first quarter of 2023 was $46.8 Million ($0.44 per basic share and
$0.41 per diluted share), compared to $19.4 Million ($0.19 per
basic share and $0.18 per diluted share) for the first quarter of
2022, representing a 132% increase YoY for each basic share and a
128% increase YoY for each diluted share.
Cash and Equivalents: Cash and
equivalents were $148.2 Million as of March 31, 2023.
_______________________
1 Statements made in this press release include
non-GAAP financial measures. Such information is provided as
additional information and not as an alternative to Catalyst's
financial statements presented in accordance with
U.S. generally accepted accounting principles (GAAP). These
non-GAAP financial measures are intended to enhance an overall
understanding of Catalyst's current financial performance. Catalyst
believes that the non-GAAP financial measures presented in this
press release provide investors and prospective investors with an
alternative method for assessing Catalyst's operating results in a
manner that Catalyst believes is focused on the performance of
ongoing operations and provides a more consistent basis for
comparison between periods. Non-GAAP financial measures should not
be considered in isolation or as a substitute for comparable GAAP
accounting. Further, non-GAAP measures of net income used by
Catalyst may be different from and not directly comparable to
similarly titled measures used by other companies.
2023 Financial
Guidance: The Company forecasts full-year 2023 total
revenues, including FYCOMPA®, to be between $375
Million and $385 Million, representing a 75% - 80%
increase in total revenues compared to 2022. Key guidance
assumptions in this forecast reflect a continued recovery in
macroeconomic and healthcare activity throughout 2023 related to
the current COVID-19 environment.
More detailed financial information and analysis
regarding the Company's financial position on March 31, 2023, and
its results of operations for the three months ended on that date
can be found in the Company's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023, filed with the U.S. Securities and
Exchange Commission ("SEC") on March 10, 2023.
Conference Call & Webcast
DetailsThe Company will host a conference call and webcast
on Thursday, May 11, 2023, at 8:30 AM ET to discuss the financial
results and provide a business update.
U.S./Canada
Dial-in Number: |
(877)
407-8912 |
International Dial-in Number: |
(201) 689-8059 |
A webcast will be accessible under the investor
section on the Company's website at www.catalystpharma.com. A
webcast replay will be available on the Catalyst website for 30
days after the event.
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 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.
_______________________
The non-GAAP financial measure included in this
press release excludes from the calculation of net income (i) the
expense associated with non-cash, stock-based compensation, (ii)
non-cash depreciation expense, (iii) non-cash amortization of
intangible assets expense, and (iv) the provision for income taxes.
Non-GAAP income per share is calculated by dividing non-GAAP income
by the weighted average common shares outstanding.
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 total revenue
forecast 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 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.
CATALYST PHARMACEUTICALS, INC.CONSOLIDATED
STATEMENTS OF OPERATIONS (unaudited)(in thousands,
except share data) |
|
|
For the Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
Revenues: |
|
|
|
Product revenue, net |
$ |
85,304 |
|
|
$ |
43,033 |
|
License and other revenue |
|
62 |
|
|
|
56 |
|
Total revenues |
|
85,366 |
|
|
|
43,089 |
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
Cost of sales (a) |
|
9,946 |
|
|
|
5,890 |
|
Research and development |
|
3,562 |
|
|
|
3,403 |
|
Selling, general and administrative (a) |
|
29,718 |
|
|
|
16,430 |
|
Amortization of intangible assets |
|
6,531 |
|
|
|
-- |
|
Total operating costs and expenses |
|
49,757 |
|
|
|
25,723 |
|
Operating income |
|
35,609 |
|
|
|
17,366 |
|
Other income, net |
|
1,704 |
|
|
|
93 |
|
Net income before income taxes |
|
37,313 |
|
|
|
17,459 |
|
Income tax provision |
|
7,745 |
|
|
|
4,218 |
|
Net income |
$ |
29,568 |
|
|
$ |
13,241 |
|
|
|
|
|
|
|
|
|
Net income per share: |
|
|
|
|
|
|
|
Basic |
$ |
0.28 |
|
|
$ |
0.13 |
|
Diluted |
$ |
0.26 |
|
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
105,561,229 |
|
|
|
102,781,771 |
|
Diluted |
|
113,986,129 |
|
|
|
109,041,096 |
|
(a) Exclusive of amortization of intangible assets
CATALYST PHARMACEUTICALS,
INC.RECONCILIATION OF NON-GAAP METRICS
(unaudited)(in thousands, except share
data) |
|
|
For the Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
GAAP
net income |
$ |
29,568 |
|
|
$ |
13,241 |
|
Non-GAAP
adjustments: |
|
|
|
|
|
|
|
Stock-based compensation expense |
|
2,892 |
|
|
|
1,903 |
|
Depreciation |
|
69 |
|
|
|
34 |
|
Amortization of intangible assets |
|
6,531 |
|
|
|
-- |
|
Income tax provision |
|
7,745 |
|
|
|
4,218 |
|
Non-GAAP net income |
$ |
46,805 |
|
|
$ |
19,396 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income per share: |
|
|
|
|
|
|
|
Basic |
$ |
0.44 |
|
|
$ |
0.19 |
|
Diluted |
$ |
0.41 |
|
|
$ |
0.18 |
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
105,561,229 |
|
|
|
102,781,771 |
|
Diluted |
|
113,986,129 |
|
|
|
109,041,096 |
|
|
|
|
|
|
|
|
|
CATALYST PHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(in
thousands) |
|
|
March 31,2023 |
|
December 31,2022 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
148,247 |
|
|
$ |
298,395 |
|
Accounts receivable, net |
|
33,402 |
|
|
|
10,439 |
|
Inventory |
|
10,328 |
|
|
|
6,805 |
|
Prepaid expenses and other current assets |
|
6,934 |
|
|
|
5,167 |
|
Total current assets |
|
198,911 |
|
|
|
320,806 |
|
Operating lease right-of-use
asset |
|
2,706 |
|
|
|
2,770 |
|
Property and equipment, net |
|
1,285 |
|
|
|
847 |
|
License and acquired intangibles,
net |
|
184,083 |
|
|
|
32,471 |
|
Deferred tax assets, net |
|
20,242 |
|
|
|
18,736 |
|
Total assets |
$ |
407,227 |
|
|
$ |
375,630 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
3,391 |
|
|
$ |
3,975 |
|
Accrued expenses and other liabilities |
|
53,318 |
|
|
|
53,613 |
|
Total current liabilities |
|
56,709 |
|
|
|
57,588 |
|
Operating lease liability, net of current portion |
|
3,468 |
|
|
|
3,557 |
|
Other non-current liabilities |
|
13,389 |
|
|
|
14,064 |
|
Total liabilities |
|
73,566 |
|
|
|
75,209 |
|
|
|
|
|
Total stockholders’ equity |
|
333,661 |
|
|
|
300,421 |
|
Total liabilities and
stockholders’ equity |
$ |
407,227 |
|
|
$ |
375,630 |
|
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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