Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company")
(Nasdaq: CPRX) today reported financial results for the fourth
quarter and full year 2023 and provided a business update.
"In 2023, Catalyst delivered exceptional
financial performance demonstrated by robust revenue growth,
exceeding our full-year guidance. Our confidence for continued
growth is strengthened by the outstanding execution of our
strategic initiatives, expansion of our product portfolio, and a
growing commercial presence in the U.S. neuroscience market,"
stated Richard J. Daly, CEO of Catalyst. "As we enter this year
with compelling momentum, our commitment to execution and
advancement of our initiatives, with a concentration on orphan CNS
and other strategic adjacencies, remains resolute. With an imminent
U.S. commercial launch for AGAMREE®, we are well poised to propel
further growth. We eagerly anticipate making this innovative
therapy available to eligible Duchenne muscular dystrophy patients.
Coupled with our accomplishments, substantial cash reserves, and
prudent financial management, we aim to further fuel our growth
through strategic avenues that will deliver further value while
upholding our steadfast commitment to serving our patient
communities."
Financial Highlights
For the Year Ended December 31, |
2023 |
2022 |
% Change |
(In thousands, except share
data) |
|
|
|
Net Product Revenue |
$396,502 |
$213,938 |
85.3% |
FIRDAPSE® Net Product Revenue |
$258,426 |
$213,938 |
20.8% |
FYCOMPA® Net Product Revenue |
$138,076 |
N/A |
N/A |
|
|
|
|
GAAP Net Income |
$71,410 |
$83,079 |
(14.0%) |
Non-GAAP Net Income ** |
$223,155 |
$113,865 |
96.0% |
|
|
|
|
GAAP Net Income Per Share - Basic |
$0.67 |
$0.80 |
(16.3%) |
Non-GAAP Net Income Per Share – Basic** |
$2.10 |
$1.10 |
90.9% |
|
|
|
|
GAAP Net Income Per Share – Diluted |
$0.63 |
$0.75 |
(16.0%) |
Non-GAAP Net Income Per Share – Diluted** |
$1.96 |
$1.02 |
92.2% |
|
|
|
|
As of December 31, |
|
|
|
Cash and Cash Equivalents |
$137,636 |
$298,395 |
(53.9%) |
|
|
|
|
**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) acquired in-process research &
development costs, and (v) the provision for income taxes. Non-GAAP
net income per share is calculated by dividing non-GAAP net income
by the weighted average shares outstanding. See the “Reconciliation
of Non-GAAP Metrics” table below.
Recent Business Highlights
- Achieved record total revenues of $110.6 million for Q4
2023 and Full Year 2023 total revenues of $398.2 million,
representing robust growth of 82.0% compared to Q4 2022 (QoQ) and
85.9% compared to Full Year 2022 (YoY), respectively.
- Achieved record FIRDAPSE net product revenue of $69.8
million for Q4 2023 and $258.4 million for the Full Year 2023,
representing growth of 15.0% compared to Q4 2022 and 20.8% compared
to Full Year 2022, respectively.
- Achieved record FYCOMPA net product revenue of $39.3
million for Q4 2023 and $138.1 million for the Full Year
2023.
- Provided Full-Year 2024 total revenue guidance of
between $455 million and $475 million,
reflecting net product revenue of approximately $295 million to
$310 million for FIRDAPSE, AGAMREE net product revenue of
approximately $25 million to $30 million and FYCOMPA net product
revenue of approximately $130 million to $135 million.
- Announced appointments of Dr. Steven Miller to Executive Vice
President, Chief Operating and Scientific Officer, Jeffrey Del
Carmen to Executive Vice President, Chief Commercial Officer, and
newly appointed Michael Kalb as Executive Vice President, Chief
Financial Officer.
- Bolstered the neuroscience franchise commercial portfolio with
the FDA approval of AGAMREE for the treatment of Duchenne muscular
dystrophy for patients aged two years and older.
- On track for the U.S. commercial launch of AGAMREE in the first
quarter of 2024.
- Announced that collaboration partner, DyDo Pharma, Inc.,
reported that it submitted a New Drug Application to Japan’s
Pharmaceuticals and Medical Devices Agency (PMDA) in December 2023,
seeking marketing approval for FIRDAPSE (amifampridine), with the
review period expected to be approximately nine months from the
submission date.
- Strengthened FIRDAPSE intellectual property estate with two new
U.S. patents issued covering methods of treating LEMS with FIRDAPSE
under fasting and fed conditions of dosing.
- Completed a $150.0 million common stock offering in January
2024 with net proceeds of approximately $140.1 million, to be
used to fund the potential acquisition of new product candidates
and for general corporate purposes.
- Ranked on Forbes 2024 List of America's Most Successful
Small-Cap Companies.
- Partnered with Sofie's Journey to bring focus on epilepsy at
the 11th Annual Epilepsy Awareness and Education Expo.
Fourth Quarter 2023 and Full Year 2023
Financial Results
Total revenues: Total revenues
in the fourth quarter of 2023 were $110.6 million, compared
to $60.8 million for the fourth quarter of 2022,
representing an increase of approximately 82.0%
quarter-over-quarter. For full-year 2023, total revenues
were $398.2 million, compared to $214.2 million for
the full-year 2022, representing an increase of approximately 85.9%
YoY.
Product revenue, net: Product
revenue, net in the fourth quarter of 2023, was $109.1 million,
compared to $60.7 million for the fourth quarter of 2022,
representing an increase of approximately 79.8% YoY. The full-year
2023 product revenue, net was $396.5 million, compared to $213.9
million for 2022, representing an increase of approximately 85.3%
YoY.
Research and development
expenses: In the fourth quarter of 2023, research and
development expenses were $2.0 million, compared
to $4.1 million in the fourth quarter of 2022. Research
and development expenses for the full-year 2023
were $93.2 million (including a one-time charge of in-process
research and development expense related to the acquisition of the
license for AGAMREE in the amount of $81.5 million), compared
to $19.8 million for the full-year 2022.
Selling, general, and administrative
expenses: Selling, general, and administrative
expenses for the fourth quarter of 2023 were $42.0
million compared to $14.1 million in the fourth quarter of 2022.
Selling, general, and administrative expenses for the full
year 2023 were $133.7 million, compared to $57.1
million for 2022. Both the QoQ and YoY increases were driven
by incremental effort to support FYCOMPA and pre-launch investments
in preparation for the acquisition of FYCOMPA in the first quarter
of 2023 and the AGAMREE launch in the first quarter of 2024.
Amortization of intangible
Assets. Amortization of intangible assets was $9.1 million
in the fourth quarter of 2023), compared to $0.6 million in the
fourth quarter of 2022. Amortization of intangible assets was $32.6
million in full-year 2023, compared to $1.1 million in full year
2022. Amortization of intangible assets acquired in 2023 relate to
the FYCOMPA rights acquired during the first quarter of 2023 and
the milestone payment made to Santhera upon the approval of AGAMREE
during the fourth quarter of 2023.
Operating
income: Operating income for the fourth quarter of
2023 was $41.7 million, compared
to $30.8 million in the fourth quarter of 2022,
representing an increase of approximately 35.4%. The
full-year 2023 operating income was $86.8 million, compared
to $101.8 million for the full year 2022,
representing a decrease of approximately 14.8%, which is inclusive
of the one-time AGAMREE related in-process R&D expense of $81.5
million in connection with the acquisition of the license.
GAAP net income: GAAP net
income for the fourth quarter of 2023 was $34.8 million ($0.33 per
basic and $0.31 per diluted share), compared to GAAP Net Income of
$25.5 million ($0.24 per basic and $0.22 per diluted share) for the
fourth quarter of 2022. GAAP net income for full year 2023 was
$71.4 million ($0.67 per basic and $0.63 per diluted share),
compared to the full year 2022 GAAP net income of $83.1 million
($0.80 per basic and $0.75 per diluted share).
Non-GAAP net
income: Non-GAAP net income for the fourth quarter of 2023
was $60.1 million ($ 0.56 per basic and $0.53 per diluted share),
compared to non-GAAP net income of $35.5 million ($0.34 per basic
and $0.31 per diluted share) for the fourth quarter of 2022.
Non-GAAP net income for full year 2023 was $223.2 million ($2.10
per basic and $1.96 per diluted share), compared to full year 2022
non-GAAP net income of $113.9 million ($1.10 per basic and $1.02
per diluted share).
Cash and cash equivalents: Cash
and cash equivalents were $137.6 million as of December 31,
2023.More detailed financial information and analysis of our
financial condition and results of operations can be found in our
Annual Report on Form 10-K for fiscal year 2023, which was filed
with the U.S. Securities and Exchange Commission on February 28,
2024.
2024 Outlook
Product revenue, net: Bolstered
by continued growth of FIRDAPSE and additional net product revenue
from AGAMREE, which we expect to launch during the first quarter of
2024, we anticipate achieving total revenues in 2024 within the
range of $455 million and $475 million, reflecting net product
revenue of approximately $295 million to $310 million for FIRDAPSE,
AGAMREE net product revenue of approximately $25 million to $30
million, and FYCOMPA net product revenue of approximately $130
million to $135 million.
Product revenue for FYCOMPA in 2024 will be
affected by differences in variable consideration (gross-to-net)
compared to 2023, when revenues were booked under Eisai’s cost
arrangements with distributors and government authorities. Starting
on January 1, 2024, all such costs are tied to arrangements between
the Company and those distributors and government agencies, which
costs are likely to be higher than Eisai’s costs, thereby
increasing the gross-to-net deductions for FYCOMPA and
correspondingly decreasing FYCOMPA net product revenue.
Research and development
expenses: Due to the expected launch of the AGAMREE
long-term safety and quality of life study, we anticipate research
and development expenses in 2024 to approximate the amount that was
incurred in 2022.
Selling, general, and administrative
expenses: We anticipate a significant increase in selling,
general and administrative expenses in 2024 due to the launch of
AGAMREE and the accompanying support of three commercial products,
compared to two in 2023.
Tax rate: We anticipate our
effective tax rate to increase slightly for 2024.
Conference Call & Webcast DetailsThe
Company will host a conference call and webcast on February 29,
2024, 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, Inc.
With exceptional patient focus, Catalyst is
committed to developing and commercializing innovative
first-in-class medicines that address rare and difficult to treat
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 revenues and net product revenue forecasts
for 2024 will prove to be accurate, (vi) whether Catalyst will
complete more acquisitions of products, and the timing of such
acquisition; and (vii) those factors described in Catalyst's Annual
Report on Form 10-K for the 2023 fiscal year, 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 |
(in
thousands, except share data) |
|
|
|
|
|
(Unaudited)For the Three
MonthsEnded December 31, |
|
For the YearEnded December
31, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
Product revenue, net |
$ |
109,104 |
|
$ |
60,683 |
|
$ |
396,502 |
|
$ |
213,938 |
License and other revenue |
|
1,464 |
|
|
74 |
|
|
1,702 |
|
|
265 |
Total revenues |
|
110,568 |
|
|
60,757 |
|
|
398,204 |
|
|
214,203 |
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
Cost of sales (a) |
|
15,809 |
|
|
11,195 |
|
|
51,967 |
|
|
34,393 |
Research and development |
|
1,972 |
|
|
4,093 |
|
|
93,150 |
|
|
19,789 |
Selling, general and administrative (a) |
|
42,036 |
|
|
14,088 |
|
|
133,710 |
|
|
57,085 |
Amortization of intangible assets |
|
9,059 |
|
|
580 |
|
|
32,565 |
|
|
1,098 |
Total operating costs and expenses |
|
68,876 |
|
|
29,956 |
|
|
311,392 |
|
|
112,365 |
Operating income |
|
41,692 |
|
|
30,801 |
|
|
86,812 |
|
|
101,838 |
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
5,015 |
|
|
2,207 |
|
|
7,699 |
|
|
2,881 |
Net income before income taxes |
|
46,707 |
|
|
33,008 |
|
|
94,511 |
|
|
104,719 |
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
11,863 |
|
|
7,537 |
|
|
23,101 |
|
|
21,640 |
Net income |
$ |
34,844 |
|
$ |
25,471 |
|
$ |
71,410 |
|
$ |
83,079 |
|
|
|
|
|
|
|
|
Net income per share: |
|
|
|
|
|
|
|
Basic |
$ |
0.33 |
|
$ |
0.24 |
|
$ |
0.67 |
|
$ |
0.80 |
Diluted |
$ |
0.31 |
|
$ |
0.22 |
|
$ |
0.63 |
|
$ |
0.75 |
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
106,714,944 |
|
|
104,583,296 |
|
|
106,279,736 |
|
|
103,374,606 |
Diluted |
|
113,755,677 |
|
|
113,531,124 |
|
|
113,753,154 |
|
|
111,375,631 |
|
|
|
|
|
|
|
|
|
|
|
|
(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 December
31, |
|
For the Year Ended December
31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
GAAP net income: |
$ |
34,844 |
|
$ |
25,471 |
|
$ |
71,410 |
|
$ |
83,079 |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Stock-based compensation expense |
|
4,250 |
|
|
1,926 |
|
|
14,250 |
|
|
7,907 |
Depreciation |
|
84 |
|
|
35 |
|
|
316 |
|
|
141 |
Amortization of intangible assets |
|
9,059 |
|
|
580 |
|
|
32,565 |
|
|
1,098 |
Income tax provision |
|
11,863 |
|
|
7,537 |
|
|
23,101 |
|
|
21,640 |
In-process R&D |
|
-- |
|
|
-- |
|
|
81,513 |
|
|
-- |
Non-GAAP net income |
$ |
60,100 |
|
$ |
35,549 |
|
$ |
223,155 |
|
$ |
113,865 |
Non-GAAP net income
per share: |
|
|
|
|
|
|
|
Basic |
$ |
0.56 |
|
$ |
0.34 |
|
$ |
2.10 |
|
$ |
1.10 |
Diluted |
$ |
0.53 |
|
$ |
0.31 |
|
$ |
1.96 |
|
$ |
1.02 |
|
|
|
|
|
|
|
|
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
106,714,944 |
|
|
104,583,296 |
|
|
106,279,736 |
|
|
103,374,606 |
Diluted |
|
113,755,677 |
|
|
113,531,124 |
|
|
113,753,154 |
|
|
111,375,631 |
|
|
|
|
|
|
|
|
CATALYST
PHARMACEUTICALS, INC. |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
(in
thousands) |
|
|
December 31,2023 |
|
December 31, 2022 |
Assets |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
137,636 |
|
$ |
298,395 |
Accounts receivable, net |
|
53,514 |
|
|
10,439 |
Inventory |
|
15,644 |
|
|
6,805 |
Prepaid expenses and other current assets |
|
12,535 |
|
|
5,167 |
Total current assets |
|
219,329 |
|
|
320,806 |
|
|
|
|
|
|
Operating lease right-of-use asset |
|
2,508 |
|
|
2,770 |
Property and equipment, net |
|
1,195 |
|
|
847 |
License and acquired intangibles, net |
|
194,049 |
|
|
32,471 |
Deferred tax assets, net |
|
36,544 |
|
|
18,736 |
Investment in equity securities |
|
16,489 |
|
|
— |
Total assets |
$ |
470,114 |
|
$ |
375,630 |
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
14,795 |
|
$ |
3,975 |
Accrued expenses and other liabilities |
|
61,268 |
|
|
53,613 |
Total current liabilities |
|
76,063 |
|
|
57,588 |
Operating lease liability, net of current portion |
|
3,188 |
|
|
3,557 |
Other non-current liabilities |
|
2,982 |
|
|
14,064 |
Total liabilities |
|
82,233 |
|
|
75,209 |
|
|
|
|
|
|
Total stockholders’ equity |
|
387,881 |
|
|
300,421 |
Total liabilities and stockholders’ equity |
$ |
470,114 |
|
$ |
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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