Catalyst Pharmaceuticals, Inc. ("Catalyst" or "the Company")
(Nasdaq: CPRX) today reported financial results for the third
quarter of 2023 and provided a corporate update.
"Our strong results in the third quarter reflect
our exceptional strategic execution and substantial investment in
assisting the physician community to better identify and treat LEMS
patients with and without small-cell lung cancer. Our quarterly
results were exceptional, having attained several significant
milestones that have transformed the long-term growth trajectory of
our Company," stated Patrick J. McEnany, Catalyst's Chairman and
CEO. "We are working diligently in preparation for the commercial
launch of AGAMREE® during the first quarter of 2024. We are pleased
to be able to provide AGAMREE to the DMD community, many who have
been anxiously awaiting the availability of a steroid with a
favorable safety profile. Our highly skilled and experienced
neuromuscular commercial and medical affairs teams will be ready to
hit the ground running for the commercial launch of AGAMREE. As we
look ahead to the coming year, we are confident in our ability to
execute our strategic plans, laying the foundation for continued
growth and sustained progress."
Financial Highlights (in Millions of U.S. dollars,
except per share data, unaudited)
For the Three Months Ended September 30, |
|
2023 |
|
|
2022 |
|
% Change |
|
|
|
|
Total Net Product Revenues |
$ |
102,617 |
|
$ |
57,173 |
|
79.5 |
% |
FIRDAPSE Net Product Revenues |
$ |
66,224 |
|
$ |
57,173 |
|
15.8 |
% |
FYCOMPA Net Product Revenues |
$ |
36,393 |
|
|
N/A |
|
N/A |
|
|
|
|
|
GAAP Net
Income (Loss) |
$ |
(30,764 |
) |
$ |
22,748 |
|
(235.2 |
)% |
Non-GAAP
Net Income ** |
$ |
55,870 |
|
$ |
28,615 |
|
95.2 |
% |
|
|
|
|
GAAP Net
Income (Loss) Per Share - Basic |
$ |
(0.29 |
) |
$ |
0.22 |
|
(231.1 |
)% |
Non-GAAP
Net Income Per Share – Basic** |
$ |
0.52 |
|
$ |
0.28 |
|
85.7 |
% |
|
|
|
|
GAAP Net
Income (Loss) Per Share – Diluted |
$ |
(0.29 |
) |
$ |
0.20 |
|
(242.1 |
)% |
Non-GAAP
Net Income Per Share – Diluted** |
$ |
0.49 |
|
$ |
0.26 |
|
88.5 |
% |
|
|
|
|
As of September 30, 2023, and December 31, 2022Cash and Cash
Equivalents |
$ |
120,971 |
|
$ |
298,395 |
|
(59.4 |
%) |
**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.
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, (iv) the provision (benefit) for income
taxes and (v) acquired in-process research & development costs.
Non-GAAP income per share is calculated by dividing non-GAAP income
by the weighted average shares outstanding. See the "Reconciliation
of Non-GAAP Metrics" table below.
Recent Business Highlights
- Achieved record total net revenues of $102.7 million,
reflecting a YoY increase of 79.4%
- Reached new all-time high FIRDAPSE® net product revenue of
$66.2 million, reflecting an exceptional 15.8% year-over-year
growth increase and 23.1% growth increase YTD.
- Achieved FYCOMPA® net product revenue of $36.4 million,
establishing a 5.2% full-quarter increase compared to Q2 2023.
- Raised 2023 full-year total revenue guidance to between $390
million and $395 million.
- Announced FDA approval of AGAMREE® (vamorolone), a novel
corticosteroid for the treatment of Duchenne muscular
dystrophy.
- Anticipate AGAMREE commercial launch by our neuromuscular
franchise teams in the first quarter of 2024.
- sNDA seeking to increase FIRDAPSE (amifampridine) maximum daily
dose to 100mg for the treatment of Lambert-Eaton myasthenic
syndrome was accepted for filing with a PDUFA action date of June
4, 2024.
- Two new patents for FIRDAPSE have recently been allowed and
upon issuance will be added to the FDA's Orange Book further
strengthening our intellectual property portfolio for
FIRDAPSE.
- Expect submission of NDA for FIRDAPSE (amifampridine) by DyDo
Pharma to PMDA in Japan by the end of 2023. Plans are being
developed to expand the global footprint for FIRDAPSE into other
Asian and South American markets through strategic partnerships
upon acceptance of the NDA in Japan.
- Active due diligence is underway on several epilepsy and other
neuroscience related opportunities, which hold further strategic
potential for 2024 if a transaction is successfully completed.
- Appointed Richard J. Daly as the Company's new CEO, effective
on January 1, 2024.
- Announced that Patrick J. McEnany, who will retire as the
Company's CEO at the end of the year, was honored with the 2023
Lifetime Achievement Award by BioFlorida.
Financial Results for the Third Quarter
2023
Product Revenues, Net: Product
revenues, net in the third quarter of 2023, were $102.6 million,
compared to $57.2 million for the third quarter of 2022,
representing an increase of 79.5% year-over-year.
Research and Development
Expenses: Research and development expenses were $83.7
million in the third quarter of 2023 compared to $8.3 million for
the third quarter of 2022. The increase in R&D for the third
quarter 2023 is driven by a one-time charge of $81.5 million for
in-process research and development (IPR&D) in connection with
the asset acquisition of AGAMREE (vamorolone) during July 2023.
Selling, General, and Administrative
Expenses: Selling, general, and administrative expenses
for the third quarter of 2023 were $33.6 million, compared to $13.6
million in the third quarter of 2022.
Amortization of Intangible
Assets: Amortization of intangible assets was $8.5 million
in the third quarter of 2023, compared to $518 thousand in the
third quarter of 2022. Intangible assets acquired after the third
quarter of 2022 relate to the FYCOMPA rights acquired in the first
quarter of 2023.
GAAP Net Income (Loss): GAAP
net loss for the third quarter of 2023 was ($30.8) million (($0.29)
per basic and diluted share), compared to net income of $22.7
million ($0.22 per basic share and $0.20 per diluted share) for the
third quarter of 2022, representing a 235.2% decrease YoY.
Non-GAAP Net Income: Non-GAAP
net income for the third quarter of 2023 was $55.9 million ($0.52
per basic share and $0.49 per diluted share), compared to $28.6
million ($0.28 per basic share and $0.26 per diluted share) for the
third quarter of 2022, representing an 87.5% increase YoY for each
basic share and an 88.5% increase YoY for each diluted share.
Cash and Cash Equivalents: Cash
and cash equivalents were $121.0 million as of September 30,
2023.
2023 Financial Guidance: The
Company forecasts full-year 2023 total revenues, including FYCOMPA,
to be between $390 million and $395 million,
representing an 82% to 84% 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 September 30, 2023,
and its results of operations for the three and nine-month periods
ended on that date, can be found in the Company's Quarterly Report
on Form 10-Q filed with the U.S. Securities and Exchange Commission
("SEC") on November 8, 2023.
Conference Call & Webcast DetailsThe
Company will host a conference call and webcast on Thursday,
November 9, 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 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. Finally, on July 18, 2023,
Catalyst acquired an exclusive license for North
America for AGAMREE® (vamorolone) oral suspension 40 mg/mL, a
novel corticosteroid treatment for Duchenne Muscular
Dystrophy. AGAMREE previously received FDA Orphan Drug and
Fast Track designations and was approved by the FDA for
commercialization in the U.S. on October 26, 2023.
For more information about Catalyst
Pharmaceuticals, Inc., visit the Company's website
at www.catalystpharma.com. For Full Prescribing and Safety
Information for FIRDAPSE®, visit www.firdapse.com. For Full
Prescribing Information, including Boxed WARNING for FYCOMPA®,
please visit www.fycompa.com. For Full Prescribing Information
for AGAMREE, please visit https://www.agamree.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) whether AGAMREE can be
successfully launched and whether that launch will occur in the
first quarter of 2024, (ii) whether AGAMREE's commercialization
will be successful and accretive to Catalyst (iii) Catalyst's
ability to continue to sell its current products, (iv) whether
Catalyst will continue to be profitable and cash flow positive, (v)
whether Catalyst's total revenue forecast for 2023 will prove to be
accurate, (vi) whether Catalyst will complete an acquisition of an
epilepsy or other neuroscience related opportunity, and the timing
of such acquisition; 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 second quarter of
2023, 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.
Source: Catalyst Pharmaceuticals, Inc.
|
|
|
|
CATALYST PHARMACEUTICALS, INC.CONSOLIDATED
STATEMENTS OF OPERATIONS (unaudited)(in thousands,
except share data) |
|
|
|
|
|
For the Three MonthsEnded September
30, |
|
For the Nine MonthsEnded September
30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
Product revenue, net |
$ |
102,617 |
|
|
$ |
57,173 |
|
|
$ |
287,398 |
|
|
$ |
153,255 |
License and other revenue |
|
71 |
|
|
|
71 |
|
|
|
238 |
|
|
|
191 |
Total revenues |
|
102,688 |
|
|
|
57,244 |
|
|
|
287,636 |
|
|
|
153,446 |
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
Cost of sales (a) |
|
14,167 |
|
|
|
9,665 |
|
|
|
36,158 |
|
|
|
23,198 |
Research and development |
|
83,662 |
|
|
|
8,310 |
|
|
|
91,178 |
|
|
|
15,696 |
Selling, general and administrative (a) |
|
33,560 |
|
|
|
13,649 |
|
|
|
91,674 |
|
|
|
42,997 |
Amortization of intangible assets |
|
8,487 |
|
|
|
518 |
|
|
|
23,506 |
|
|
|
518 |
Total operating costs and expenses |
|
139,876 |
|
|
|
32,142 |
|
|
|
242,516 |
|
|
|
82,409 |
Operating income (loss) |
|
(37,188 |
) |
|
|
25,102 |
|
|
|
45,120 |
|
|
|
71,037 |
Other income (expense),
net |
|
(833 |
) |
|
|
905 |
|
|
|
2,684 |
|
|
|
674 |
Net income (loss) before income taxes |
|
(38,021 |
) |
|
|
26,007 |
|
|
|
47,804 |
|
|
|
71,711 |
Income tax provision
(benefit) |
|
(7,257 |
) |
|
|
3,259 |
|
|
|
11,238 |
|
|
|
14,103 |
Net income (loss) |
$ |
(30,764 |
) |
|
$ |
22,748 |
|
|
$ |
36,566 |
|
|
$ |
57,608 |
|
|
|
|
|
|
|
|
Net income (loss) per
share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.29 |
) |
|
$ |
0.22 |
|
|
$ |
0.34 |
|
|
$ |
0.56 |
Diluted |
$ |
(0.29 |
) |
|
$ |
0.20 |
|
|
$ |
0.32 |
|
|
$ |
0.52 |
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
106,568,137 |
|
|
|
103,318,572 |
|
|
|
106,133,077 |
|
|
|
102,967,280 |
Diluted |
|
106,568,137 |
|
|
|
111,986,025 |
|
|
|
113,751,370 |
|
|
|
110,352,214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) exclusive of
amortization of intangible assets |
|
|
|
|
|
|
CATALYST PHARMACEUTICALS,
INC.RECONCILIATION OF NON-GAAP METRICS
(unaudited)(in thousands, except share
data) |
|
|
|
|
|
|
|
|
For the Three MonthsEnded September
30, |
|
|
For the Nine MonthsEnded September
30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
GAAP net income
(loss): |
$ |
(30,764 |
) |
|
$ |
22,748 |
|
|
$ |
36,566 |
|
|
$ |
57,608 |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Stock-based compensation expense |
|
3,810 |
|
|
|
2,055 |
|
|
|
10,000 |
|
|
|
5,981 |
Depreciation |
|
81 |
|
|
|
35 |
|
|
|
232 |
|
|
|
106 |
Amortization of intangible assets |
|
8,487 |
|
|
|
518 |
|
|
|
23,506 |
|
|
|
518 |
Income tax provision (benefit) |
|
(7,257 |
) |
|
|
3,259 |
|
|
|
11,238 |
|
|
|
14,103 |
In-process R&D |
|
81,513 |
|
|
|
-- |
|
|
|
81,513 |
|
|
|
-- |
Non-GAAP net income (loss) |
$ |
55,870 |
|
|
$ |
28,615 |
|
|
$ |
163,055 |
|
|
$ |
78,316 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.52 |
|
|
$ |
0.28 |
|
|
$ |
1.54 |
|
|
$ |
0.76 |
Diluted |
$ |
0.49 |
|
|
$ |
0.26 |
|
|
$ |
1.43 |
|
|
$ |
0.71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
106,568,137 |
|
|
|
103,318,572 |
|
|
|
106,133,077 |
|
|
|
102,967,280 |
Diluted |
|
113,551,919 |
|
|
|
111,986,025 |
|
|
|
113,751,370 |
|
|
|
110,352,214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CATALYST PHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(in
thousands) |
|
|
|
|
|
September
30,2023(unaudited) |
|
December 31, 2022 |
Assets |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
120,971 |
|
$ |
298,395 |
Accounts receivable, net |
|
48,049 |
|
|
10,439 |
Inventory |
|
9,035 |
|
|
6,805 |
Prepaid expenses and other current assets |
|
13,962 |
|
|
5,167 |
Total current assets |
|
192,017 |
|
|
320,806 |
Operating lease right-of-use asset |
|
2,575 |
|
|
2,770 |
Property and equipment, net |
|
1,186 |
|
|
847 |
License and acquired intangibles, net |
|
167,108 |
|
|
32,471 |
Deferred tax assets, net |
|
37,428 |
|
|
18,736 |
Investment in equity securities |
|
12,897 |
|
|
-- |
Total assets |
$ |
413,211 |
|
$ |
375,630 |
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
4,598 |
|
$ |
3,975 |
Accrued expenses and other liabilities |
|
53,208 |
|
|
53,613 |
Total current liabilities |
|
57,806 |
|
|
57,588 |
Operating lease liability, net of current portion |
|
3,282 |
|
|
3,557 |
Other non-current liabilities |
|
3,575 |
|
|
14,064 |
Total liabilities |
|
64,663 |
|
|
75,209 |
Total stockholders' equity |
|
348,548 |
|
|
300,421 |
Total liabilities and stockholders' equity |
$ |
413,211 |
|
$ |
375,630 |
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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