Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company")
(Nasdaq: CPRX) today reported financial results for the first
quarter of 2024 and provided a business update.
“Our strong performance in the first quarter
provides us with the momentum for continued growth throughout the
year,” stated Richard Daly, President and Chief Executive Officer
of Catalyst. “The successful U.S. launch of AGAMREE and sustained
double-digit growth of FIRDAPSE are a testament to our team’s
commitment to serving patients through innovative products and
outstanding execution. Building on the positive indicators observed
during the initial phase of AGAMREE’s launch further strengthens
our confidence for accelerated growth of this critically important
product.”
Financial Highlights
For the Three Months Ended March 31, |
|
2024 |
|
|
|
2023 |
|
|
% Change |
(In
thousands, except per share data) |
|
|
|
Product Revenue, net |
$ |
98,441 |
|
|
$ |
85,304 |
|
|
|
15.4 |
% |
FIRDAPSE Product Revenue, net |
$ |
66,842 |
|
|
$ |
57,526 |
|
|
|
16.2 |
% |
FYCOMPA Product Revenue, net** |
$ |
30,425 |
|
|
$ |
27,778 |
|
|
|
9.5 |
% |
AGAMREE Product Revenue, net |
$ |
1,174 |
|
|
|
N/A |
|
|
N/A |
GAAP Net
Income |
$ |
23,275 |
|
|
$ |
29,568 |
|
|
|
(21.3 |
%) |
Non-GAAP
Net Income *** |
$ |
46,767 |
|
|
$ |
46,805 |
|
|
|
(0.1 |
%) |
|
|
|
|
GAAP Net
Income Per Share - Basic |
$ |
0.20 |
|
|
$ |
0.28 |
|
|
|
(28.6 |
%) |
Non-GAAP
Net Income Per Share – Basic*** |
$ |
0.40 |
|
|
$ |
0.44 |
|
|
|
(9.1 |
%) |
|
|
|
|
GAAP Net
Income Per Share – Diluted |
$ |
0.19 |
|
|
$ |
0.26 |
|
|
|
(26.9 |
%) |
Non-GAAP
Net Income Per Share – Diluted*** |
$ |
0.38 |
|
|
$ |
0.41 |
|
|
|
(7.3 |
%) |
|
|
|
|
As of March 31, 2024 and December 31, 2023(In
thousands)Cash and Cash Equivalents |
$ |
310,411 |
|
|
$ |
137,636 |
|
|
|
125.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
_________________________________** For Q1 2023,
represents product revenue, net from the date of acquisition of the
product rights.
*** 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, and (iv) 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 solid performance with Q1
2024 total revenues of $98.5 million, reflecting a 15.4% increase
compared to Q1 2023, driven by the persistent demand for the
Company's innovative commercial products.
- Promptly implemented measures to
ensure uninterrupted patient access to treatment amidst external
third-party prescription processing disruptions while sustaining
the compelling product growth momentum.
- Delivered outstanding growth
performance for FIRDAPSE, achieving net product revenues of $66.8
million for Q1 2024, representing growth of 16.2% compared to
Q1 2023, despite transient revenue impact by external disruptions
in prescription processing during the period.
- Achieved FYCOMPA net product
revenues of $30.4 million for Q1 2024, representing growth of
9.5% compared to Q1 2023. Revenue growth reflects the full quarter
for Q1 2024, compared to the partial Q1 2023 period, due to the
timing of the acquisition.
- Successfully commenced the U.S.
AGAMREE commercial launch, an innovative corticosteroid for the
treatment of Duchenne muscular dystrophy in patients aged two years
and older, on March 13, 2024.
- Early indicators for the AGAMREE
U.S. launch show strong demand exceeding initial expectations.
- Reported AGAMREE net product
revenues of $1.2 million for Q1 2024, reflecting approximately the
first two weeks of U.S. commercial availability.
- Endorsed the inaugural
Lambert-Eaton myasthenic syndrome ("LEMS") Awareness Day, now
officially observed annually on March 30th, marking a significant
milestone for the LEMS community.
- Strong cash position of $310.4
million as of March 31, 2024, fortified by the approximately $140.7
million in net proceeds yielded from the 10 million shares of
common stock offering in January 2024.
- Reaffirm the 2024 full-year total
revenue guidance in the range of $455 million and $475
million.
First Quarter 2024 Financial
Results
Total revenues: In the first
quarter of 2024, total revenues were $98.5 million, compared
to $85.4 million for the first quarter of 2023,
representing an increase of approximately 15.4%.
Product revenue, net: Product
revenue, net for the first quarter of 2024 was $98.4 million,
compared to $85.3 million for the first quarter of 2023,
representing an increase of approximately 15.4%.
Research and development
expenses: Research and development expenses for the first
quarter of 2024 were $2.6 million, compared to $3.6
million for the first quarter of 2023, representing a decrease of
approximately 27.5%.
Selling, general, and administrative
expenses: Selling, general, and administrative
expenses for the first quarter of 2024 were $46.9
million, compared to $29.7 million for the first quarter of 2023,
representing an increase of approximately 57.9% primarily relating
to preparation for the launch of AGAMREE.
Amortization of intangible
assets: Amortization of intangible assets was $9.3 million
in the first quarter of 2024, compared to $6.5 million in the first
quarter of 2023, representing an increase of approximately
43.1%.
Operating
income: Operating income for the first quarter of
2024 was $27.1 million, compared to $35.6 million for the
first quarter of 2023, representing a decrease of approximately
23.8%.
GAAP net income: GAAP net
income for the first quarter of 2024 was $23.3 million ($0.20 per
basic and $0.19 per diluted share), compared to GAAP net income of
$29.6 million ($0.28 per basic and $0.26 per diluted share) for the
first quarter of 2023.
Non-GAAP net income: Non-GAAP
net income for the first quarter of 2024 was $46.8 million ($0.40
per basic and $0.38 per diluted share), compared to non-GAAP net
income of $46.8 million ($0.44 per basic and $0.41 per diluted
share) for the first quarter of 2023.
Cash and cash equivalents: Cash
and cash equivalents were $310.4 million as of March 31, 2024.
Our Form 10-Q for the first quarter of 2024,
filed with the U.S. Securities and Exchange Commission on May 8,
2024, provides more detailed financial information and analysis of
our financial condition and results of operations.
Conference Call & Webcast
Details The Company will host a conference call and
webcast on May 9, 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. On July 18th, 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 26th, 2023. AGAMREE became
available in the U.S. by prescription on March 13,
2024.
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 www.agamree.com.
Forward-Looking StatementsThis
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 the launch of AGAMREE® will surpass initial
expectations and exceed 2024 full-year revenue forecasts for sales
of the product that were previously published by the Company (ii)
whether AGAMREE's commercialization will ultimately be profitable,
cash flow positive, and accretive to Catalyst, (iii) Catalyst's
ability to continue to successfully sell its current products, (iv)
whether Catalyst will continue to be profitable and cash flow
positive, (v) whether Catalyst's total revenue forecast for 2024
included in this press release will prove to be accurate, (vi)
whether Catalyst will complete additional acquisitions of products,
and the timing of any such acquisitions; (vii) the impact of
pending Paragraph IV litigation relating to the Company’s FIRDAPSE®
and FYCOMPA® products if the results of these litigation matters
are adverse, and (viii) those factors described in Catalyst's
Annual Report on Form 10-K for the 2023 fiscal year, Catalyst's
Quarterly Report on Form 10-Q for the first quarter of 2024, 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.
CATALYST PHARMACEUTICALS, INC.CONSOLIDATED
STATEMENTS OF OPERATIONS (unaudited)(in thousands,
except share and per share data) |
|
|
For the Three Months Ended March 31, |
|
|
2024 |
|
|
|
2023 |
|
Revenues: |
|
|
|
|
|
Product revenue, net |
$ |
98,441 |
|
|
$ |
85,304 |
|
License and other revenue |
|
68 |
|
|
|
62 |
|
Total revenues |
|
98,509 |
|
|
|
85,366 |
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
Cost of sales (a) |
|
12,520 |
|
|
|
9,946 |
|
Research and development |
|
2,581 |
|
|
|
3,562 |
|
Selling, general and administrative (a) |
|
46,938 |
|
|
|
29,718 |
|
Amortization of intangible assets |
|
9,344 |
|
|
|
6,531 |
|
Total operating costs and expenses |
|
71,383 |
|
|
|
49,757 |
|
Operating income |
|
27,126 |
|
|
|
35,609 |
|
Other income, net |
|
1,963 |
|
|
|
1,704 |
|
Net income before income taxes |
|
29,089 |
|
|
|
37,313 |
|
Income tax provision |
|
5,814 |
|
|
|
7,745 |
|
Net income |
$ |
23,275 |
|
|
$ |
29,568 |
|
Net income per share: |
|
|
|
|
|
Basic |
$ |
0.20 |
|
|
$ |
0.28 |
|
Diluted |
$ |
0.19 |
|
|
$ |
0.26 |
|
Weighted average shares
outstanding:Basic |
|
116,806,117 |
|
|
|
105,561,229 |
|
Diluted |
|
123,403,626 |
|
|
|
113,986,129 |
|
_________________________________________(a)
exclusive of amortization of intangible assets
CATALYST
PHARMACEUTICALS, INC.RECONCILIATION OF NON-GAAP
METRICS (unaudited)(in thousands, except share and
per share data) |
|
|
|
For the Three Months Ended March 31, |
|
2024 |
|
2023 |
GAAP
net income |
$ |
23,275 |
|
|
$ |
29,568 |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Stock-based compensation expense |
|
8,248 |
|
|
|
2,892 |
|
Depreciation |
|
86 |
|
|
|
69 |
|
Amortization of intangible assets |
|
9,344 |
|
|
|
6,531 |
|
Income tax provision |
|
5,814 |
|
|
|
7,745 |
|
Non-GAAP net income |
$ |
46,767 |
|
|
$ |
46,805 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income per share: |
|
|
|
|
|
|
|
Basic |
$ |
0.40 |
|
|
$ |
0.44 |
|
Diluted |
$ |
0.38 |
|
|
$ |
0.41 |
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
116,806,117 |
|
|
|
105,561,229 |
|
Diluted |
|
123,403,626 |
|
|
|
113,986,129 |
|
CATALYST
PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED
BALANCE SHEETS(in thousands) |
|
|
March 31,2024 |
|
December 31,2023 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
310,411 |
|
|
$ |
137,636 |
|
Accounts receivable, net |
|
60,493 |
|
|
|
53,514 |
|
Inventory |
|
19,953 |
|
|
|
15,644 |
|
Prepaid expenses and other current assets |
|
13,745 |
|
|
|
12,535 |
|
Total current assets |
|
404,602 |
|
|
|
219,329 |
|
Operating lease right-of-use
asset |
|
2,440 |
|
|
|
2,508 |
|
Property and equipment, net |
|
1,308 |
|
|
|
1,195 |
|
License and acquired intangibles,
net |
|
184,705 |
|
|
|
194,049 |
|
Deferred tax assets, net |
|
38,276 |
|
|
|
36,544 |
|
Investment in equity
securities |
|
15,345 |
|
|
|
16,489 |
|
Total assets |
$ |
646,676 |
|
|
$ |
470,114 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
10,261 |
|
|
$ |
14,795 |
|
Accrued expenses and other liabilities |
|
69,305 |
|
|
|
61,268 |
|
Total current liabilities |
|
79,566 |
|
|
|
76,063 |
|
Operating lease liability, net of current portion |
|
3,091 |
|
|
|
3,188 |
|
Other non-current liabilities |
|
2,607 |
|
|
|
2,982 |
|
Total liabilities |
|
85,264 |
|
|
|
82,233 |
|
|
|
|
|
Total stockholders' equity |
|
561,412 |
|
|
|
387,881 |
|
Total liabilities and stockholders' equity |
$ |
646,676 |
|
|
$ |
470,114 |
|
Source: Catalyst Pharmaceuticals, Inc.
Contact Information:
Investor ContactMary Coleman,
Catalyst Pharmaceuticals, Inc.(305)
420-3200mcoleman@catalystpharma.com
Media ContactDavid Schull,
Russo Partners(858) 717-2310david.schull@russopartnersllc.com
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