Catalyst Pharmaceuticals, Inc. (“Catalyst” or “the Company”)
(Nasdaq: CPRX) today reported financial results for the second
quarter of 2023 and provided a corporate update.
"We are extremely pleased with the remarkable
progress we achieved during the first half of 2023, fueled by the
sustained and exceptional organic growth of FIRDAPSE, a significant
contributor to our revenue accomplishments. Moreover, our sales of
FYCOMPA, which we acquired at the end of January 2023, have
bolstered our success for the first half of 2023, and we have
recently completed our integration of the FYCOMPA team and believe
that FYCOMPA will be a synergistic and meaningful contributor to
our future revenue potential," stated Patrick J. McEnany, Chairman
and CEO of Catalyst. "Our most recent acquisition, which we closed
in July, is the North American license for vamorolone, a late-stage
asset with a PDUFA action date of October 26th, 2023, for the
treatment of Duchenne muscular dystrophy. Assuming approval, this
product is expected to further strengthen our neuromuscular product
portfolio. Results achieved from these significant accomplishments
have established a robust foundation to advance our strategic
initiatives and reinforce the durability of our near and long-term
growth potential. We look forward to achieving numerous important
milestones in the second half of this year to further build an even
more vital business."
Financial Highlights (in Millions of U.S. dollars,
except per share data, unaudited)
For the Three Months Ended June 30, |
2023 |
2022 |
% Change |
|
|
|
|
|
Total Net Product Revenues |
$99.5 |
$53.0 |
87.5% |
|
FIRDAPSE Net Product Revenues |
$64.9 |
$53.0 |
22.3% |
|
FYCOMPA Net Product Revenues |
$34.6 |
N/A |
N/A |
|
|
|
|
|
GAAP Net
Income |
$37.8 |
$21.6 |
74.7% |
|
Non-GAAP
Net Income ** |
$60.4 |
$30.3 |
99.2% |
|
|
|
|
|
GAAP Net
Income Per Share - Basic |
$0.36 |
$0.21 |
69.0% |
|
Non-GAAP
Net Income Per Share – Basic** |
$0.57 |
$0.29 |
92.8% |
|
|
|
|
|
GAAP Net
Income Per Share – Diluted |
$0.33 |
$0.20 |
67.9% |
|
Non-GAAP
Net Income Per Share – Diluted** |
$0.53 |
$0.28 |
91.5% |
|
|
|
|
|
Cash and Cash Equivalents |
$178.8 (a) |
$220.8 |
|
(a) Post June 30, 2023, cash was used for the following: (i) $75
million for the North American License for vamorolone; (ii)
approximately $15 million for the equity investment in Santhera;
and (iii) $10 million to pay the second installment of the purchase
price for the Ruzurgi acquisition.
**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 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 all-time high total
revenues of $99.6 million for Q2 2023, an 87.5% YoY increase, and a
16.7% increase compared to Q1 2023, bolstered by continued organic
growth of FIRDAPSE and the addition of FYCOMPA net product
revenues.
- Achieved an all-time record high of
FIRDAPSE net product revenue of $64.9 million for the second
quarter of 2023, representing an exceptional 22.3% YoY
increase.
- Reported strong FYCOMPA net product
revenues of $34.6 million and completed the seamless integration of
the FYCOMPA commercial and medical affairs teams during the second
quarter of 2023.
- Raised 2023 full-year total revenue
guidance to between $380 million and $390 million.
- Appointed Ms. Tamar Thompson to our
Board of Directors.
- Acquired the North American license
for vamorolone, a treatment candidate for Duchenne muscular
dystrophy, from Santhera Pharmaceuticals, with a PDUFA date of
October 26, 2023. Developing the commercial plan for an anticipated
launch (assuming approval of the product by the PDUFA date) in
Q1-24.
- Submitted sNDA seeking to increase
the maximum daily dosage of FIRDAPSE (amifampridine) to 100mg for
the treatment of Lambert-Eaton myasthenic syndrome.
- Anticipate that DyDo Pharma, our
partner in Japan, will submit their NDA for FIRDAPSE
(amifampridine) to the Pharmaceuticals and Medical Devices Agency,
(“PMDA”) by the end of 2023. Under our license with SERB
(previously BioMarin), when this submission to PMDA is completed,
it will provide us with further geographical rights for FIRDAPSE
and we will begin exploring partnerships, especially in
specifically targeted markets like China and South Korea.
- Continue to pursue the acquisition
of innovative rare neurological and epilepsy assets in alignment
with our portfolio expansion strategy.
- Launched the Company’s inaugural
ESG Report highlighting the Company's ESG strategy, areas of focus,
and meaningful progress in key areas.
Financial Results for Second Quarter
2023
Product Revenues, Net: Product
revenues, net in the second quarter of 2023, were $99.5 million,
compared to $53.0 million for the second quarter of 2022,
representing an increase of 87.5% year-over-year.
Research and Development
Expenses: Research and development expenses were $4.0
million in both the second quarter of 2023 and 2022.
Selling, General, and Administrative
Expenses: Selling, general, and administrative expenses
for the second quarter of 2023 were $28.4 million, compared to
$12.9 million in the second quarter of 2022.
Amortization of Intangible
Assets: Amortization of intangible assets was $8.5 million
in the second quarter of 2023, compared to $0 million in the second
quarter of 2022. Intangible assets acquired subsequent to the
second quarter of 2022 relate to the FYCOMPA rights acquired in the
first quarter of 2023 and the RUZURGI® rights acquired in the third
quarter of 2022.
Operating Income: Operating
income for the second quarter of 2023 was $46.7 million, compared
to $28.6 million in the second quarter of 2022, representing an
increase of 63.5% year-over-year.
GAAP Net Income: GAAP net
income for the second quarter of 2023 was $37.8 million ($0.36 per
basic share and $0.33 per diluted share), compared to $21.6 million
($0.21 per basic share and $0.20 per diluted share) for the second
quarter of 2022, representing a 74.7% increase YoY.
Non-GAAP Net Income: Non-GAAP
net income for the second quarter of 2023 was $60.4 million ($0.57
per basic share and $0.53 per diluted share), compared to $30.3
million ($0.29 per basic share and $0.28 per diluted share) for the
second quarter of 2022, representing a 92.8% increase YoY for each
basic share and a 91.5% increase YoY for each diluted share.
Cash and Cash Equivalents: Cash
and cash equivalents were $178.8 million as of June 30, 2023.
2023 Financial Guidance:
The Company forecasts full-year 2023 total revenues, including
FYCOMPA, to be between $380 million and $390
million, representing a 77% to 82% 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 June 30, 2023, and
its results of operations can be found in the Company's Quarterly
Report on Form 10-Q filed with the U.S. Securities and Exchange
Commission ("SEC") on August 9, 2023.
Conference Call & Webcast DetailsThe
Company will host a conference call and webcast on Thursday, August
10, 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. Further, on July 18, 2023, Catalyst acquired an
exclusive license for North America for vamorolone, a promising
best-in-class dissociative anti-inflammatory steroid treatment for
Duchenne muscular dystrophy. Vamorolone has received FDA Orphan
Drug and Fast Track designations and has been granted a PDUFA
action date of October 26, 2023.
For more information about Catalyst
Pharmaceuticals, Inc., visit the Company’s website at:
www.catalystpharma.com. For the Full Prescribing and Safety
Information for FIRDAPSE®, please visit www.firdapse.com. For
the Full Prescribing Information for FYCOMPA®, please
visit www.fycompa.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 the NDA for vamorolone
will be approved by the PDUFA date, or at all, (ii) Catalyst's
ability to continue to sell its current products, (iii) whether
Catalyst will continue to be profitable and cash flow positive,
(iv) whether Catalyst’s total revenue forecast for 2023 will prove
to be accurate, and (v) 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 first 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 June
30, |
|
For the Six MonthsEnded June
30, |
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
Product revenue, net |
$ |
99,477 |
|
$ |
53,049 |
|
|
$ |
184,781 |
|
$ |
96,082 |
|
License and other revenue |
|
105 |
|
|
64 |
|
|
|
167 |
|
|
120 |
|
Total revenues |
|
99,582 |
|
|
53,113 |
|
|
|
184,948 |
|
|
96,202 |
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
Cost of sales (a) |
|
12,045 |
|
|
7,643 |
|
|
|
21,991 |
|
|
13,533 |
|
Research and development |
|
3,954 |
|
|
3,983 |
|
|
|
7,516 |
|
|
7,386 |
|
Selling, general and administrative (a) |
|
28,396 |
|
|
12,918 |
|
|
|
58,114 |
|
|
29,348 |
|
Amortization of intangible assets |
|
8,488 |
|
|
-- |
|
|
|
15,019 |
|
|
-- |
|
Total operating costs and expenses |
|
52,883 |
|
|
24,544 |
|
|
|
102,640 |
|
|
50,267 |
|
Operating income |
|
46,699 |
|
|
28,569 |
|
|
|
82,308 |
|
|
45,935 |
|
Other income (expense),
net |
|
1,813 |
|
|
(324) |
|
|
|
3,517 |
|
|
(231) |
|
Net income before income taxes |
|
48,512 |
|
|
28,245 |
|
|
|
85,825 |
|
|
45,704 |
|
Income tax provision |
|
10,750 |
|
|
6,626 |
|
|
|
18,495 |
|
|
10,844 |
|
Net income |
$ |
37,762 |
|
$ |
21,619 |
|
|
$ |
67,330 |
|
$ |
34,860 |
|
|
|
|
|
|
|
|
|
Net income per share: |
|
|
|
|
|
|
|
Basic |
$ |
0.36 |
|
$ |
0.21 |
|
|
$ |
0.64 |
|
$ |
0.34 |
|
Diluted |
$ |
0.33 |
|
$ |
0.20 |
|
|
$ |
0.59 |
|
$ |
0.32 |
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
106,258,790 |
|
|
102,795,600 |
|
|
|
105,911,936 |
|
|
102,788,719 |
|
Diluted |
|
113,673,534 |
|
|
109,264,730 |
|
|
|
113,840,155 |
|
|
109,149,185 |
|
(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 June
30, |
|
For the Six MonthsEnded June
30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
GAAP net
income |
$ |
37,762 |
|
$ |
21,619 |
|
$ |
67,330 |
|
$ |
34,860 |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Stock-based compensation expense |
|
3,298 |
|
|
2,023 |
|
|
6,190 |
|
|
3,926 |
Depreciation |
|
82 |
|
|
37 |
|
|
151 |
|
|
71 |
Amortization of intangible assets |
|
8,488 |
|
|
-- |
|
|
15,019 |
|
|
-- |
Income tax provision |
|
10,750 |
|
|
6,626 |
|
|
18,495 |
|
|
10,844 |
Non-GAAP net income |
$ |
60,380 |
|
$ |
30,305 |
|
$ |
107,185 |
|
$ |
49,701 |
Non-GAAP net income
per share: |
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.57 |
|
$ |
0.29 |
|
$ |
1.01 |
|
$ |
0.48 |
Diluted |
$ |
|
0.53 |
|
$ |
0.28 |
$ |
0.94 |
|
$ |
0.46 |
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
Basic |
106,528,790 |
|
102,795,600 |
|
105,911,936 |
|
|
102,788,719 |
Diluted |
113,673,534 |
|
109,264,730 |
113,840,155 |
|
|
109,149,185 |
|
|
|
|
|
|
|
|
CATALYST PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands)
|
June
30,2023(unaudited) |
|
December 31, 2022 |
Assets |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
178,787 |
|
$ |
298,395 |
Accounts receivable, net |
|
42,796 |
|
|
10,439 |
Inventory |
|
10,751 |
|
|
6,805 |
Prepaid expenses and other current assets |
|
8,634 |
|
|
5,167 |
Total current assets |
|
240,968 |
|
|
320,806 |
Operating lease right-of-use asset |
|
2,641 |
|
|
2,770 |
Property and equipment, net |
|
1,203 |
|
|
847 |
License and acquired intangibles, net |
|
175,595 |
|
|
32,471 |
Deferred tax assets, net |
|
23,489 |
|
|
18,736 |
Total assets |
$ |
443,896 |
|
$ |
375,630 |
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
4,421 |
|
$ |
3,975 |
Accrued expenses and other liabilities |
|
48,082 |
|
|
53,613 |
Total current liabilities |
|
52,503 |
|
|
57,588 |
Operating lease liability, net of current portion |
|
3,376 |
|
|
3,557 |
Other non-current liabilities |
|
12,723 |
|
|
14,064 |
Total liabilities |
|
68,602 |
|
|
75,209 |
Total stockholders’ equity |
|
375,294 |
|
|
300,421 |
Total liabilities and stockholders’ equity |
$ |
443,896 |
|
$ |
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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