Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a
commercial-stage biopharmaceutical company focused on in-licensing,
developing, and commercializing novel medicines for patients living
with rare diseases, today reported financial results for the first
quarter 2022 and provided a corporate update.
"I am proud of Catalyst’s solid progress in the
first quarter of 2022, where we delivered record revenues, driven
in part, by new patients converting to FIRDAPSE® following the
removal of Ruzurgi® from the U. S. market in February 2022. Our
accomplishments exemplify our exceptional commercial and patient
services capabilities and steadfast commitment to the LEMS patient
community that we serve," said Patrick J. McEnany, Chairman and
Chief Executive Officer of Catalyst. "We also achieved several
meaningful milestones during the quarter, including the issuance of
three new patents that we believe position us to deliver
sustainable long-term growth for FIRDAPSE. We anticipate this to be
a transformative year for Catalyst, as we work with increased
momentum to diversify and invest in innovative therapeutic
opportunities for rare diseases. We approach these objectives from
a position of strength and look forward to enhancing our growth
potential near-term, as well as adding long-term value for all of
our stakeholders."
RECENT BUSINESS HIGHLIGHTS
- Reported record
total revenue of $43.1 million for the first quarter of 2022,
compared to $30.2 million in the comparable 2021 period, a 42.7%
increase, reflecting steady growth for
FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of
Lambert-Eaton myasthenic syndrome ("LEMS") in adults.
- Recently
completed the seamless transition of numerous LEMS patients who
were former Ruzurgi patients converting to FIRDAPSE treatment, with
the support provided by our Catalyst Pathways® assistance
program.
- Organic growth
in new FIRDAPSE patients continues to be strong, due to improved
diagnosis rates, expanded reach to thoracic oncologists, and
continued low patient discontinuations.
- Strengthened
FIRDAPSE patent protection and long-term commercial potential with
three new patents listed in the Orange Book covering additional
patient amifampridine metabolizer types.
- Received
favorable Canadian Federal Court ruling enforcing
FIRDAPSE (amifampridine) Innovative Drug data protection.
Currently, FIRDAPSE® is the only approved product in Canada for
adult LEMS patients.
- Submitted a
supplemental New Drug Application to the FDA to support the
approved use of FIRDAPSE for the treatment of pediatric LEMS
patients.
- Continued momentum in advancing
strategic initiatives to diversify the business and invest in
innovative opportunities for rare diseases.
- On Global Rare
Disease Day in February, partnered with rare disease patients and
advocacy groups to help raise awareness of the need for new
treatments.
First Quarter 2022 Financial
Results
Total revenue: Total revenue in
the first quarter of 2022 was $43.1 million, compared
to $30.2 million for the first quarter of 2021,
representing an increase of 42.7% year-over-year.
Research and development
expenses: R&D expenses in the first
quarter of 2022 were $3.4 million, compared to R&D expenses of
$3.0 million in the first quarter of 2021.
Selling, general, and administrative
expenses: Selling, general, and administrative
expenses for the first quarter of 2022 were $16.4
million, compared to $12.7 million in the first quarter of
2021.
Operating income:
Operating income for the first quarter of 2022 was $17.4
million, compared to $9.8 million in the first
quarter of 2021, representing an increase of 77.2%
year-over-year.
GAAP Net Income for the first
quarter of 2022 was $13.2 million ($0.13 per basic and $0.12 per
diluted share), compared to $7.7 million ($0.07 per basic and
diluted share) for the first quarter of 2021, representing a
year-over-year increase of 72.8%.
Non-GAAP Financial Measures
Non-GAAP1 net income for the first quarter of
2022 was $19.4 million ($0.19 per basic and $0.18 per diluted
share), which excludes from GAAP net income of $13.2 million (i)
stock-based compensation expense of $1.9 million, (ii) depreciation
of $34 thousand, and (iii) the provision for income taxes of $4.2
million. This compares to non-GAAP1 net income for the first
quarter of 2021 of $11.6 million ($0.11 per basic and diluted
share), which excludes from GAAP net income of $7.7 million (i)
stock-based compensation expense of $1.6 million, (ii) depreciation
of $97 thousand, and (iii) a provision for income taxes of $2.2
million. A tabular presentation of non-GAAP1 net income for the
three months ended March 31, 2022 and 2021 is included below.
More detailed financial information and analysis
can be found in the Company's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2022, which was filed with the Securities
and Exchange Commission (“SEC”) on May 10, 2022.
Cash and investments were $198
million as of March 31, 2022, with no funded debt.
Share repurchase program: The
Company implemented a share repurchase program in March 2021. As of
March 31, 2022, the Company had repurchased 2.6 million shares of
Catalyst common stock in the open market, at an average price of
$5.61 per share, for a total purchase price of $14.6 million.
2022 Financial Guidance: The
Company continues to forecast full year 2022 total revenues to be
in the range of between $195 million and $205 million,
representing a 38% - 45% increase in total revenues as compared to
2021, with cash operating expenses for the full year 2022 expected
to be in the range of $65 million to $70 million. Key guidance
assumptions included in these forecasts reflect a continued
recovery in macroeconomic and healthcare activity throughout 2022
as it relates to the current COVID-19 environment.
______________________________
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 the
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.
The non-GAAP financial measure in this press
release excludes from the calculation of net income (i) the expense
associated with non-cash, stock-based compensation, (ii)
depreciation expense, and (iii) the provision for income taxes.
Non-GAAP income per share is calculated by dividing non-GAAP income
by the weighted average common shares outstanding.
Conference Call & Webcast
Details
The Company will host a conference call and
webcast on Wednesday, May 11, 2022, at 8:30 AM ET to discuss
the financial results and provide a business update.
US/Canada Dial-in Number: |
(877) 407-8912 |
International Dial-in Number: |
(201) 689-8059 |
A webcast and accompanying materials will be
accessible under the investor section on the Company's website at
www.catalystpharma.com. A replay of the webcast will be available
on the Catalyst website for 30 days following the date of the
event.
About Catalyst
Pharmaceuticals
Catalyst Pharmaceuticals is a
commercial-stage biopharmaceutical company focused on in-licensing,
developing, and commercializing novel medicines for patients living
with rare diseases. With exceptional patient focus, Catalyst is
committed to developing a robust pipeline of cutting-edge,
best-in-class medicines for rare diseases. Catalyst's New Drug
Application for FIRDAPSE® (amifampridine) Tablets 10 mg for
the treatment of adults with Lambert-Eaton myasthenic syndrome
("LEMS") was approved in 2018 by the U.S. Food & Drug
Administration ("FDA"), and FIRDAPSE is commercially available
in the United States as a treatment for adults with LEMS.
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.
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 continuing effect of the
COVID-19 pandemic on Catalyst's business and results of operations,
(ii) Catalyst's ability to locate and acquire new product
candidates through acquisition or in-licensing, (iii) Catalyst's
ability to successfully develop any new product candidates acquired
or in-licensed, (iv) whether Catalyst's total revenue and cash
operating expenses forecasts for 2022 will prove to be accurate,
and (v) those factors described in Catalyst's Annual Report on Form
10-K for the fiscal year 2021 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.
|
CATALYST PHARMACEUTICALS, INC.CONSOLIDATED
STATEMENTS OF OPERATIONS (unaudited)(in thousands,
except share data) |
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
43,033 |
|
|
$ |
30,205 |
|
License and other revenue |
|
|
56 |
|
|
|
-- |
|
Total revenues |
|
|
43,089 |
|
|
|
30,205 |
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
Cost of sales |
|
|
5,890 |
|
|
|
4,681 |
|
Research and development |
|
|
3,403 |
|
|
|
3,007 |
|
Selling, general and administrative |
|
|
16,430 |
|
|
|
12,716 |
|
Total operating costs and expenses |
|
|
25,723 |
|
|
|
20,404 |
|
Operating income |
|
|
17,366 |
|
|
|
9,801 |
|
Other income, net |
|
|
93 |
|
|
|
81 |
|
Net income before income taxes |
|
|
17,459 |
|
|
|
9,882 |
|
Income tax provision |
|
|
4,218 |
|
|
|
2,219 |
|
Net income |
|
$ |
13,241 |
|
|
$ |
7,663 |
|
|
|
|
|
|
|
|
|
|
Net income per share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.13 |
|
|
$ |
0.07 |
|
Diluted |
|
$ |
0.12 |
|
|
$ |
0.07 |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
102,781,771 |
|
|
|
103,814,725 |
|
Diluted |
|
|
109,041,096 |
|
|
|
106,680,344 |
|
|
|
|
|
|
|
|
|
|
|
CATALYST PHARMACEUTICALS,
INC.RECONCILIATION OF NON-GAAP METRICS
(unaudited)(in thousands, except share
data) |
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
GAAP net income |
|
$ |
13,241 |
|
|
$ |
7,663 |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
1,903 |
|
|
|
1,571 |
|
Depreciation |
|
|
34 |
|
|
|
97 |
|
Income tax provision |
|
|
4,218 |
|
|
|
2,219 |
|
Non-GAAP net
income |
|
$ |
19,396 |
|
|
$ |
11,550 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income per
share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.19 |
|
|
$ |
0.11 |
|
Diluted |
|
$ |
0.18 |
|
|
$ |
0.11 |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
102,781,771 |
|
|
|
103,814,725 |
|
Diluted |
|
|
109,041,096 |
|
|
|
106,680,344 |
|
|
|
|
|
|
|
|
|
|
|
CATALYST PHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(in
thousands) |
|
|
|
|
|
March 31,2022 |
|
December 31,2021 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
178,372 |
|
|
$ |
171,445 |
|
Short-term investments |
|
19,424 |
|
|
|
19,821 |
|
Accounts receivable, net |
|
10,552 |
|
|
|
6,619 |
|
Inventory |
|
7,827 |
|
|
|
7,870 |
|
Prepaid expenses and other current assets |
|
5,016 |
|
|
|
4,351 |
|
Total current assets |
|
221,191 |
|
|
|
210,106 |
|
Operating lease right-of-use
asset |
|
2,957 |
|
|
|
3,017 |
|
Property and equipment, net |
|
925 |
|
|
|
959 |
|
Deferred tax assets, net |
|
21,890 |
|
|
|
23,697 |
|
Deposits |
|
9 |
|
|
|
9 |
|
Total assets |
$ |
246,972 |
|
|
$ |
237,788 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
5,139 |
|
|
$ |
2,768 |
|
Accrued expenses and other liabilities |
|
17,799 |
|
|
|
24,295 |
|
Total current liabilities |
|
22,938 |
|
|
|
27,063 |
|
Operating lease liability, net of current portion |
|
3,813 |
|
|
|
3,894 |
|
Total liabilities |
|
26,751 |
|
|
|
30,957 |
|
|
|
|
|
Total stockholders’ equity |
|
220,221 |
|
|
|
206,831 |
|
Total liabilities and
stockholders’ equity |
$ |
246,972 |
|
|
$ |
237,788 |
|
|
|
|
|
|
|
|
|
Media Contact
David Schull
Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com
Investor Contact
Mary Coleman
Catalyst Pharmaceuticals, Inc.
(305) 420-3200
mcoleman@catalystpharma.com
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