Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a
commercial-stage biopharmaceutical company focused on developing
and commercializing innovative therapies for people with rare
debilitating, chronic neuromuscular and neurological diseases,
today reported financial results for the first quarter ended March
31, 2020 and provided a corporate update.
“I am very proud of the way that the entire
Catalyst team has quickly responded and adapted in these
challenging and unprecedented times to ensure the safety of all
employees, while still providing uninterrupted access to Firdapse®
for LEMS patients and continuing our support with their healthcare
providers, albeit remotely” said Patrick J. McEnany, Chairman and
Chief Executive Officer of Catalyst Pharmaceuticals. “We entered
2020 with a very clear operational plan to drive the growth of the
Firdapse franchise, advance our clinical development programs,
including MuSK antibody positive Myasthenia Gravis, and secure our
supply chain and safety stock of Firdapse. We have made progress
against all of these objectives and our first quarter results
reflect the solid execution of this plan.”
Q1-20 Financial Results
- Reported net product revenue of $29.1 million in the first
quarter 2020 compared to $12.4 million in the first quarter of
2019, an increase of $16.7 million, or 134%.
- Reported GAAP net income of $10.4 million, or $0.10 per basic
and diluted share, for the first quarter of 2020, compared with a
GAAP net loss of $645 thousand, or $0.01 per basic and diluted
share, for the first quarter of 2019.
- Research and development expenses for the first quarter of 2020
were $4.2 million as compared to $3.3 million for the first quarter
of 2019.
- Selling, general and administrative expenses for the first
quarter of 2020 totaled $10.1 million as compared to $8.4 million
in the first quarter of 2019.
- Ended March 31, 2020 with $101.8 million in cash and
investments and no funded debt.
Recent Developments and
Highlights
- In the first quarter nearly doubled the size of our field sales
force and contracted with a rare-disease experienced inside sales
agency to support our commercial efforts.
- Increased our marketing efforts in non-personal promotion and
digital communications.
- 46 new LEMS patients were prescribed Firdapse in first quarter
of 2020.
Financial Highlights and Guidance
- Withdrawing previously provided 2020 revenue guidance due to
the uncertainties surrounding COVID-19 disruptions to the
healthcare system.
- Strong balance sheet with $101.8 million in cash and
investments, and no funded debt.
- Focused on exercising financial discipline.
Upcoming Milestones
- Expect to report top-line results from Phase 3 trial for
MuSK-MG in the third quarter of 2020.
- Expect to report top-line results from the SMA Type 3 proof of
concept trial before the end of 2020.
- Expect potential approval of New Drug Submission (NDS) for
Firdapse to treat LEMS in Canada in the second half of 2020.
- Expect to submit a supplemental NDA for Firdapse for MuSK-MG,
assuming successful completion of the MSK-002 trial, later this
year or early next year.
COVID-19 Impact
- Issued a no travel and remote work policy for all Catalyst
employees on March 16th.
- Our first quarter revenues were minimally impacted by
COVID-19.
- We believe that our current base of LEMS patients on reimbursed
Firdapse is fairly stable and very compliant to their medication
regimen.
- Top-line data for MuSK-MG trial has moved to third quarter as a
result of clinical trial sites temporarily suspending trial
activities.
- Have not experienced any disruptions in the supply chain or
production of Firdapse.
- Completed manufacturing campaigns to provide Firdapse inventory
through June 2021, with new campaigns underway.
- Partnered with First Responder’s Children’s Foundation/COVID-19
Emergency Response Fund, which provides emergency grants to support
frontline emergency and healthcare workers and their families
enduring financial hardship during this COVID-19 pandemic.
Financial Results
For the quarter ended March 31, 2020, Catalyst
reported net income of $10.4 million, or $0.10 per basic and
diluted share, compared to a net loss of $645 thousand, or $0.01
per basic and diluted share, for the same period in 2019. Excluding
expenses related to stock-based compensation of $1.5 million,
non-GAAP1 net income for the first quarter of 2020 was $11.9
million, or $0.12 per basic share and $0.11 per diluted share. This
compares to a non-GAAP1 net income of $289 thousand, or $0.00 per
basic and diluted share, excluding stock-based compensation expense
of $933 thousand, for the first quarter of 2019.
_________________________
1 Statements made in this press release
include a non-GAAP financial measure. 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). This non-GAAP financial
measure is intended to enhance an overall understanding of
Catalyst's current financial performance. Catalyst believes that
the non-GAAP financial measure presented in this press release
provides 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. The non-GAAP financial measure in this press
release excludes from the calculation of net income (loss) the
expense associated with non-cash stock-based compensation.
Non-GAAP income (loss) per share is calculated by dividing non-GAAP
income (loss) by the weighted average common shares
outstanding.
Catalyst launched its first product, Firdapse,
in January 2019. Related product revenues, net for the quarter
ended March 31, 2020 were $29.1 million compared to $12.4 million
in the same period of 2019. Cost of sales for the quarter ended
March 31, 2020 were $4.2 million compared to $1.7 million in the
same period in 2019.
Research and development expenses for the first
quarter of 2020 were $4.2 million, compared to $3.3 million in the
first quarter of 2019. The increase of $915 thousand in
research and development expenses for the first three months of
2020 is primarily attributable to increases in headcount, medical
and regulatory affairs, quality assurance programs, and expenses
from our Firdapse clinical trials and studies, as well as an
increase in non-cash employee-stock based compensation. The Company
expects that costs related to research and development activities
will continue to be substantial throughout 2020 as Catalyst
continues its clinical programs evaluating Firdapse in MuSK-MG and
SMA Type 3, continues its Expanded Access Program and sustained
release product development program for Firdapse, begins to
evaluate Firdapse as a treatment for other neuromuscular diseases
and, assuming positive results from the trial, prepares a sNDA for
Firdapse for the treatment of MuSK-MG.
Selling, general and administrative expenses for
the first quarter of 2020 totaled $10.1 million as compared to $8.4
million in the first quarter of 2019. The increase when compared to
the same period in 2019 is primarily due to additional cost from
expansion of the sales force and contracting with a rare-disease
experienced inside sales agency, and an increase in non-cash
stock-based compensation. The Company expects selling, general and
administrative expenses to increase in 2020, as the Company
continues to build its infrastructure and commercial and patient
programs in support of Firdapse sales activities.
At March 31, 2020, Catalyst had cash and cash
equivalents and investments of $101.8 million and no funded-debt.
Catalyst believes that its existing capital resources will be
sufficient to support its planned operations for at least the next
12 months.
More detailed financial information and analysis
may be found in the Company's Quarterly Report on Form 10-Q, which
was filed with the Securities and Exchange
Commission (SEC) on May 11, 2020.
Conference Call
Catalyst management will host an
investment-community conference call and webcast at 8:30 a.m. ET,
tomorrow, Tuesday, May 12, 2020 to discuss the financial results
and provide a corporate update. Investors who wish to participate
in the conference call may do so by dialing (877) 407-8912 for
domestic and Canadian callers or (201) 689-8059 for international
callers. Those interested in listening to the conference call live
via the internet may do so by visiting the Investors page of the
company's website at www.catalystpharma.com and clicking on
the webcast link on the Investors home page. A webcast replay will
be available on the Catalyst website for 30 days following the call
by visiting the Investor page of the company's website at
www.catalystpharma.com.
About Catalyst
Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for people with rare debilitating, chronic
neuromuscular and neurological diseases, including Lambert-Eaton
myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia
gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3.
Catalyst's new drug application for Firdapse® (amifampridine) 10 mg
tablets for the treatment of adults with LEMS was approved in
November 2018 by the U.S. Food & Drug
Administration ("FDA"), and Firdapse is now commercially
available in the United States as a treatment for adults (age
17 and up) with LEMS. Prior to its approval, Firdapse for LEMS had
received breakthrough therapy designation and orphan drug
designation from the FDA.
Firdapse is currently being evaluated in
clinical trials for the treatment of MuSK-MG and SMA Type 3 and has
received Orphan Drug Designation from the FDA for
myasthenia gravis.
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) the impact of the effects of the
COVID-19 pandemic on Catalyst's 2020 net product revenues and on
the timeline for reporting the top-line results from Catalyst's
MuSK-MG trial and SMA Type 3 proof-of-concept study, and (ii) those
factors described in Catalyst's Annual Report on Form 10-K for the
fiscal year 2019 and Catalyst's other filings with the U.S.
Securities and Exchange Commission (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)
|
|
For the Three Months Ended March
31, |
|
|
|
2020 |
|
|
2019 |
|
Product revenue, net |
|
$ |
29,136,472 |
|
$ |
12,448,438 |
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
Cost of sales |
|
|
4,150,866 |
|
|
1,711,788 |
|
Research and development |
|
|
4,222,811 |
|
|
3,307,959 |
|
Selling, general and administrative |
|
|
10,063,048 |
|
|
8,416,460 |
|
Total operating costs and expenses |
|
|
18,436,725 |
|
|
13,436,207 |
|
Operating income (loss) |
|
|
10,699,747 |
|
|
(987,769 |
) |
Other income, net |
|
|
336,233 |
|
|
343,266 |
|
Net income (loss) before income taxes |
|
|
11,035,980 |
|
|
(644,503 |
) |
Provision for income taxes |
|
|
609,965 |
|
|
-- |
|
Net income (loss) |
|
$ |
10,426,015 |
|
$ |
(644,503 |
) |
Net income (loss) per share – basic and diluted |
|
$ |
0.10 |
|
$ |
(0.01 |
) |
Weighted average shares
outstanding – basic |
|
|
103,407,347 |
|
|
102,747,923 |
|
Weighted average shares
outstanding – diluted |
|
|
106,534,600 |
|
|
102,747,923 |
|
CATALYST PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS
|
March 31,
2020 |
|
December 31,
2019 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
101,750,937 |
|
$ |
89,511,710 |
Short-term investments |
|
-- |
|
|
5,007,050 |
Accounts receivable, net |
|
6,918,563 |
|
|
10,536,997 |
Inventory |
|
2,211,338 |
|
|
1,956,792 |
Prepaid expenses and other current assets |
|
6,062,715 |
|
|
4,351,074 |
Total current assets |
|
116,943,553 |
|
|
111,363,623 |
Operating lease right-of-use asset |
|
730,284 |
|
|
793,252 |
Property and equipment, net |
|
196,926 |
|
|
210,467 |
Deposits |
|
8,888 |
|
|
8,888 |
Total assets |
$ |
117,879,651 |
|
$ |
112,376,230 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
1,347,577 |
|
$ |
4,117,447 |
Accrued expenses and other liabilities |
|
16,287,936 |
|
|
19,981,295 |
Total current liabilities |
|
17,635,513 |
|
|
24,098,742 |
Operating lease liability, net of current portion |
|
568,421 |
|
|
647,532 |
Total liabilities |
|
18,203,934 |
|
|
24,746,274 |
|
|
|
|
Total stockholders’ equity |
|
99,675,717 |
|
|
87,629,956 |
Total liabilities and stockholders’ equity |
$ |
117,879,651 |
|
$ |
112,376,230 |
Investor Contact
Brian Korb
Solebury Trout
(646) 378-2923
bkorb@troutgroup.com
Company Contact
Patrick J. McEnany
Catalyst Pharmaceuticals
Chief Executive Officer
(305) 420-3200
pmcenany@catalystpharma.com
Media Contact
David Schull
Russo Partners
(212) 845-4271
david.schull@russopartnersllc.com
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