Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”)
(Nasdaq: CPRX) today reported financial results for the second
quarter of 2024 and provided a corporate update.
"Since the onset of this year, we have advanced
with continued momentum, propelled by the strong performance of our
established product portfolio and the successful U.S. commercial
launch of AGAMREE. Our accomplishments have significantly
strengthened our financial position, aligning with our revenue
guidance for the year, and we believe that we are on track to
achieve the upper end of our previously provided total revenue
forecast,” stated Richard J. Daly, President and CEO of Catalyst.
"With unwavering confidence in our ability to execute our strategic
objectives, we remain steadfast in our plans to capitalize on new
opportunities to broaden our rare orphan portfolio with innovative
and differentiated products and expand our market presence, as
exemplified by our recent license agreement for AGAMREE in Canada.
As we continue to execute our business strategy, we remain focused
on enhancing our growth potential and delivering value to our
stakeholders, while prioritizing the needs of our patient
communities. Backed by our proven track record and dedicated team,
we believe that we are well-positioned for sustained success."
Financial Highlights
For the Three Months Ended June 30, |
|
2024 |
|
|
2023 |
|
% Change |
(In
thousands, except per share data) |
|
|
|
Product Revenue, Net |
$ |
122,653 |
|
$ |
99,477 |
|
|
23.3 |
% |
FIRDAPSE Product Revenue, Net |
$ |
77,372 |
|
$ |
64,898 |
|
|
19.2 |
% |
FYCOMPA Product Revenue, Net |
$ |
36,535 |
|
$ |
34,579 |
|
|
5.7 |
% |
AGAMREE Product Revenue, Net |
$ |
8,746 |
|
|
N/A |
|
|
N/A |
|
GAAP Net
Income |
$ |
40,794 |
|
$ |
37,762 |
|
|
8.0 |
% |
Non-GAAP
Net Income ** |
$ |
69,631 |
|
$ |
60,380 |
|
|
15.3 |
% |
|
|
|
|
GAAP Net
Income Per Share - Basic |
$ |
0.35 |
|
$ |
0.36 |
|
|
(2.8 |
%) |
Non-GAAP
Net Income Per Share – Basic** |
$ |
0.59 |
|
$ |
0.57 |
|
|
3.5 |
% |
|
|
|
|
GAAP Net
Income Per Share – Diluted |
$ |
0.33 |
|
$ |
0.33 |
|
|
0 |
% |
Non-GAAP
Net Income Per Share – Diluted** |
$ |
0.56 |
|
$ |
0.53 |
|
|
5.7 |
% |
|
|
|
|
As of June 30, 2024, and December 31, 2023(In
thousands)Cash and Cash Equivalents |
$ |
375,693 |
|
$ |
137,636 |
|
|
173.0 |
% |
**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.
Recent Business Highlights
- Achieved strong results with total
net product revenues amounting to $122.7 million for Q2 2024,
reflecting a robust 23.3% YoY increase.
- Delivered outstanding FIRDAPSE net
product revenues of $77.4 million for Q2 2024, evidenced by
impressive 19.2% YoY growth.
- Successfully executed the U.S.
commercial launch of AGAMREE, a novel corticosteroid treatment for
Duchenne Muscular Dystrophy, yielding solid results and surpassing
our initial expectations.
- Reported AGAMREE
net product revenues of $8.7 million for Q2 2024, marking the first
full quarter of U.S. commercial availability.
- Achieved Q2 2024 FYCOMPA net
product revenues of $36.5 million, representing a 5.7% YoY
performance.
- On May 30, 2024, the FDA approved
the 100 mg maximum daily dose of FIRDAPSE, enhancing treatment
flexibility for healthcare providers treating LEMS patients.
- In July 2024, Catalyst secured an
exclusive license, supply, and commercialization agreement with KYE
Pharmaceuticals, Inc., for AGAMREE in Canada, marking a pivotal
strategic milestone in expanding the product's North American
footprint.
- Published the Company’s 2023 ESG
Report in June 2024, highlighting key achievements and
initiatives.
- We currently believe that our total
revenue for the year ending December 31, 2024 will be in the upper
half of our previously reported total revenue guidance of between
$455 million and $475 million.
- We are reaffirming our full-year
2024 FIRDAPSE net product revenue guidance to be
approximately $295 million to $310 million and our
2024 FYCOMPA net product revenue guidance to be
approximately $130 million to $135 million,
respectively.
- We are increasing our full-year
2024 net product revenue guidance for AGAMREE to be
approximately $35 million to $40 million, based on
the promising demand trend and an encouraging payer landscape.
Second Quarter 2024 Financial Results
Total revenues: In the second
quarter of 2024, total revenues were $122.7 million, compared
to $99.6 million for the second quarter of 2023,
representing an increase of approximately 23.2%.
Product revenue, net: Product
revenue, net for the second quarter of 2024 was $122.7 million,
compared to $99.5 million for the second quarter of 2023,
representing an increase of approximately 23.3%.
Research and development
expenses: Research and development expenses for the second
quarter of 2024 were $3.0 million, compared to $4.0
million for the second quarter of 2023, representing a decrease of
approximately 24.5%.
Selling, general, and administrative
expenses: Selling, general, and administrative
expenses for the second quarter of 2024 were $40.7
million, compared to $28.4 million for the second quarter of 2023,
representing an increase of approximately 43.4%, primarily relating
to our preparation for and commercial launch of AGAMREE.
Amortization of intangible
assets: Amortization of intangible assets was $9.3 million
in the second quarter of 2024, compared to $8.5 million in the
second quarter of 2023, representing an increase of approximately
10.1%.
Operating income: Operating
income for the second quarter of 2024 was $54.2 million,
compared to $46.7 million for the second quarter of 2023,
representing an increase of approximately 16.2%.
GAAP net income: GAAP net
income for the second quarter of 2024 was $40.8 million ($0.35 per
basic and $0.33 per diluted share), compared to GAAP net income of
$37.8 million ($0.36 per basic and $0.33 per diluted share) for the
second quarter of 2023.
Non-GAAP net income: Non-GAAP
net income for the second quarter of 2024 was $69.6 million ($0.59
per basic and $0.56 per diluted share), compared to non-GAAP net
income of $60.4 million ($0.57 per basic and $0.53 per diluted
share) for the second quarter of 2023.
Cash and cash equivalents: Cash
and cash equivalents were $375.7 million as of June 30, 2024.
Our Form 10-Q for the second quarter of 2024,
filed with the U.S. Securities and Exchange Commission on August 7,
2024, provides more detailed financial information and analysis of
our financial condition and results of operations.
Conference Call & Webcast
DetailsThe Company will host a conference call and webcast
on Thursday, August 8, 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 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") in adults
and pediatric patients 6 years of age 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. Most
recently, on May 30, 2024, the FDA approved an increased maximum
daily dose of 100 mg for FIRDAPSE for adults and pediatric patients
weighing more than 45 kg.
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.
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. AGAMREE became
commercially available by prescription in the U.S. on March 13,
2024. Further, in July 2024, Catalyst entered into an exclusive
license, supply, and commercialization agreement for AGAMREE in
Canada.
For more information about Catalyst, please
visit the Company's website at www.catalystpharma.com. 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 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 continue to 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 and
continue to be profitable and cash flow positive, (iv) whether
Catalyst's total revenue forecast for 2024 included in this press
release will prove to be accurate, (v) whether Catalyst will
complete additional acquisitions of products, and the timing of any
such acquisitions; (vi) the impact of pending Paragraph IV
litigation relating to FIRDAPSE® if the results of these litigation
matters are adverse, (vii) whether AGAMREE will be approved for
commercialization in Canada, 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 second 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 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 MonthsEnded June
30, |
|
For the Six MonthsEnded June
30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Product revenue, net |
$ |
122,653 |
|
|
$ |
99,477 |
|
|
$ |
221,094 |
|
|
$ |
184,781 |
|
License and other revenue |
|
57 |
|
|
|
105 |
|
|
|
125 |
|
|
|
167 |
|
Total revenues |
|
122,710 |
|
|
|
99,582 |
|
|
|
221,219 |
|
|
|
184,948 |
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
Cost of sales (a) |
|
15,405 |
|
|
|
12,045 |
|
|
|
27,925 |
|
|
|
21,991 |
|
Research and development |
|
2,985 |
|
|
|
3,954 |
|
|
|
5,566 |
|
|
|
7,516 |
|
Selling, general and administrative (a) |
|
40,730 |
|
|
|
28,396 |
|
|
|
87,668 |
|
|
|
58,114 |
|
Amortization of intangible assets |
|
9,344 |
|
|
|
8,488 |
|
|
|
18,688 |
|
|
|
15,019 |
|
Total operating costs and expenses |
|
68,464 |
|
|
|
52,883 |
|
|
|
139,847 |
|
|
|
102,640 |
|
Operating income |
|
54,246 |
|
|
|
46,699 |
|
|
|
81,372 |
|
|
|
82,308 |
|
Other income, net |
|
1,542 |
|
|
|
1,813 |
|
|
|
3,505 |
|
|
|
3,517 |
|
Net income before income taxes |
|
55,788 |
|
|
|
48,512 |
|
|
|
84,877 |
|
|
|
85,825 |
|
Income tax provision |
|
14,994 |
|
|
|
10,750 |
|
|
|
20,808 |
|
|
|
18,495 |
|
Net income |
$ |
40,794 |
|
|
$ |
37,762 |
|
|
$ |
64,069 |
|
|
$ |
67,330 |
|
|
|
|
|
|
|
|
|
|
|
Net income per share: |
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.35 |
|
|
$ |
0.36 |
|
|
$ |
0.55 |
|
|
$ |
0.64 |
|
Diluted |
$ |
0.33 |
|
|
$ |
0.33 |
|
|
$ |
0.52 |
|
|
$ |
0.59 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
|
Basic |
|
118,180,396 |
|
|
|
106,258,790 |
|
|
|
117,493,257 |
|
|
|
105,911,936 |
|
Diluted |
|
124,655,999 |
|
|
|
113,673,534 |
|
|
|
124,028,752 |
|
|
|
113,840,155 |
|
(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 MonthsEnded June
30, |
|
For the Six MonthsEnded June
30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP net
income |
$ |
40,794 |
|
|
$ |
37,762 |
|
|
$ |
64,069 |
|
|
$ |
67,330 |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Stock-based compensation expense |
|
4,408 |
|
|
|
3,298 |
|
|
|
12,656 |
|
|
|
6,190 |
|
Depreciation |
|
91 |
|
|
|
82 |
|
|
|
177 |
|
|
|
151 |
|
Amortization of intangible assets |
|
9,344 |
|
|
|
8,488 |
|
|
|
18,688 |
|
|
|
15,019 |
|
Income tax provision |
|
14,994 |
|
|
|
10,750 |
|
|
|
20,808 |
|
|
|
18,495 |
|
Non-GAAP net income |
$ |
69,631 |
|
|
$ |
60,380 |
|
|
$ |
116,398 |
|
|
$ |
107,185 |
|
Non-GAAP net income
per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.59 |
|
|
$ |
0.57 |
|
|
$ |
0.99 |
|
|
$ |
1.01 |
|
Diluted |
$ |
0.56 |
|
|
$ |
0.53 |
|
|
$ |
0.94 |
|
|
$ |
0.94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
118,180,396 |
|
|
|
106,258,790 |
|
|
|
117,493,257 |
|
|
|
105,911,936 |
|
Diluted |
|
124,655,999 |
|
|
|
113,673,534 |
|
|
|
124,028,752 |
|
|
|
113,840,155 |
|
|
|
|
|
|
|
|
|
|
|
|
CATALYST PHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(in
thousands) |
|
|
June
30,2024(unaudited) |
|
December 31,2023 |
Assets |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
375,693 |
|
|
$ |
137,636 |
|
Accounts receivable, net |
|
57,172 |
|
|
|
53,514 |
|
Inventory |
|
18,014 |
|
|
|
15,644 |
|
Prepaid expenses and other current assets |
|
23,550 |
|
|
|
12,535 |
|
Total current assets |
|
474,429 |
|
|
|
219,329 |
|
Operating lease right-of-use asset |
|
2,371 |
|
|
|
2,508 |
|
Property and equipment, net |
|
1,227 |
|
|
|
1,195 |
|
License and acquired intangibles, net |
|
175,361 |
|
|
|
194,049 |
|
Deferred tax assets, net |
|
39,889 |
|
|
|
36,544 |
|
Investment in equity securities |
|
13,083 |
|
|
|
16,489 |
|
Total assets |
$ |
706,360 |
|
|
$ |
470,114 |
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
7,116 |
|
|
$ |
14,795 |
|
Accrued expenses and other liabilities |
|
85,202 |
|
|
|
61,268 |
|
Total current liabilities |
|
92,318 |
|
|
|
76,063 |
|
Operating lease liability, net of current portion |
|
2,991 |
|
|
|
3,188 |
|
Other non-current liabilities |
|
2,396 |
|
|
|
2,982 |
|
Total liabilities |
|
97,705 |
|
|
|
82,233 |
|
Total stockholders’ equity |
|
608,655 |
|
|
|
387,881 |
|
Total liabilities and stockholders’ equity |
$ |
706,360 |
|
|
$ |
470,114 |
|
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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