Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a
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, 2019 and provided a
corporate update.
“The first quarter of this year was very
critical for us, as we became a fully-integrated biopharmaceutical
company with the commercial launch of Firdapse,” said Patrick J.
McEnany, Chairman and Chief Executive Officer of Catalyst
Pharmaceuticals. “We are pleased that the Firdapse launch is
off to an excellent start and while it is still early, with much
work to be done, it is especially gratifying to see the number of
patients that were previously naive to any form of amifampridine
that are now being effectively treated with Firdapse. We continue
to be motivated by the very positive response that we are receiving
from patients and healthcare providers. Lastly, we continue to make
progress in clinical development of our robust pipeline of other
potential indications for Firdapse.”
Mr. McEnany continued, “We were extremely
surprised with the FDA’s decision to approve Jacobus
Pharmaceuticals’ NDA for amifampridine in the treatment of LEMS in
a pediatric population between the ages of 6 and less than 17.
According to a Jacobus spokesperson there are less than 15
pediatric LEMS patients in the U.S. We are currently assessing our
options and we expect to have more to say in that regard in the
coming days.”
Q1-19 Financial Results
- Total net revenue in the first quarter 2019 was $12.4
million.
- Selling, general and administrative expenses for the first
quarter of 2019 totaled $8.4 million as compared to $2.7 million in
the first quarter of 2018. The increase is primarily attributed to
commercial launch expenses, as well as the patient services
programs to support Firdapse.
- Research and development expenses for the first quarter of 2019
were $3.3 million in line with the first quarter of 2018.
- Ended March 31, 2019 with $50.6 million in cash and investments
and no funded-debt.
- Reported a net loss of $645,000 or $(0.01) per basic and
diluted share, compared with a net loss of $5.7 million, or $(0.06)
per basic and diluted share, for the first quarter of 2018.
Recent Developments and
Highlights
- Received FDA approval of Firdapse new drug application on
November 28, 2018
- Initiated commercial launch of Firdapse for LEMS on January 15,
2019
- 409 unique LEMS patients prescribed Firdapse as of May 9,
2019
- 380 LEMS patients active on Firdapse as of May 9, 2019
- 214 unique prescribers that have written at least one Firdapse
prescription as of May 9, 2019
- 81 unique patients prescribed Firdapse that had previously been
naive to any form of amifampridine
- Published LMS-003 Phase 3 clinical data for Firdapse in the
Journal of Clinical Neuromuscular Disease
Upcoming Milestones
- Expect top-line results from Phase 3 trial for MuSK-MG in the
second half of 2019
- Expect top-line results from Phase 3 trial for CMS in the
second half of 2019
- Expect top-line results for SMA Type 3 proof of concept trial
in the first half of 2020
Financial Results
For the quarter ended March 31, 2019, Catalyst
reported a net loss of $644,503, or $0.01 per basic and diluted
share, compared to a net loss of $5,699,892,
or $0.06 per basic and diluted share, for the same period
in 2018.
Catalyst launched its first product, Firdapse,
in January 2019. Related product revenues, net for the quarter
ended March 31, 2019 were $12,448,438. Cost of sales for the same
quarter were $1,711,788.
Research and development expenses for the first
quarter of 2019 were $3,307,959, in line with the comparable period
in 2018 with expenses of $3,259,042. Research and development
expenses for the first three months of 2019 primarily consisted of
expenses in medical, regulatory affairs and quality assurance
programs, as well as expenses from our Firdapse clinical trials,
studies and Expanded Access Program. Research and development
expenses in the comparable period in 2018, primarily consisted of
consulting expenses as we prepared to submit our NDA for Firdapse
for the treatment of LEMS during March 2018, as well as expenses
from our Firdapse clinical trials, studies and Expanded Access
Program. The Company expects that costs related to research and
development activities will continue to be substantial throughout
2019 as it continues its on-going clinical trials and studies in
MusK-MG, CMS and SMA Type 3 and its Expanded Access Program for
Firdapse.
Selling, general and administrative expenses for
the first quarter of 2019 totaled $8,416,460 as compared to
$2,674,398 in the first quarter of 2018. The increase when compared
to the same period in 2018 is primarily due to increased selling
expenses, including the cost of our sales force and supporting
personnel, product launch expenses, market access and market
research expenses. The Company expects selling, general and
administrative expenses to increase in 2019, as we continue to
build up our infrastructure and commercial and patient programs in
support of Firdapse sales activities in 2019.
At March 31, 2019, Catalyst had cash and cash
equivalents and investments of $50.6 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
year.
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 10, 2019.
Conference Call
Catalyst management will host an
investment-community conference call and webcast at 8:30 a.m. ET,
today, Monday, May 13, 2019 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 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), congenital myasthenic syndromes (CMS), 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 recently approved by the U.S. Food & Drug
Administration ("FDA"), and Firdapse is now commercially available
in the United States. 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, CMS, and SMA Type 3
and has received Orphan Drug Designation from the FDA for CMS and
myasthenia gravis. Firdapse (amifampridine) 10 mg tablets is the
first and only approved drug in Europe for the symptomatic
treatment in adults with LEMS.
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 Catalyst will be
successful in commercializing Firdapse, (ii) whether, even if
Catalyst is successful in commercializing Firdapse, Catalyst will
become profitable, (iii) the effect on Catalyst’s business and
future results of operations of the recent approval by the FDA of
an NDA for Jacobus Pharmaceuticals for their version of 3,4-DAP for
the treatment of pediatric LEMS patients; (iv) whether Firdapse
will ever be approved for the treatment of MuSK-MG, CMS, SMA Type
3, or any other disease, and (v) those other factors described in
Catalyst's Annual Report on Form 10-K for the fiscal year 2018 and
its 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, |
|
|
|
2019 |
|
|
|
2018 |
|
Product revenue, net |
|
$ |
12,448,438 |
|
|
$ |
-- |
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
Cost of sales |
|
|
1,711,788 |
|
|
|
-- |
|
Research and development |
|
|
3,307,959 |
|
|
|
3,259,042 |
|
Selling, general and administrative |
|
|
8,416,460 |
|
|
|
2,674,398 |
|
Total operating costs and expenses |
|
|
13,436,207 |
|
|
|
5,933,440 |
|
Loss from operations |
|
|
(987,769 |
) |
|
|
(5,933,440 |
) |
Other income, net |
|
|
343,266 |
|
|
|
233,548 |
|
Loss before income taxes |
|
|
(644,503 |
) |
|
|
(5,699,892 |
) |
Provision for income taxes |
|
|
-- |
|
|
|
-- |
|
Net loss |
|
$ |
(644,503 |
) |
|
$ |
(5,699,892 |
) |
Net loss per share – basic and diluted |
|
$ |
(0.01 |
) |
|
$ |
(0.06 |
) |
Weighted average shares
outstanding – basic and diluted |
|
|
102,747,923 |
|
|
|
102,557,350 |
|
|
|
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|
March 31,
2019 |
|
December 31,
2018 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
19,081,714 |
|
$ |
16,559,400 |
Short-term investments |
|
26,551,064 |
|
|
36,922,213 |
Accounts receivable, net |
|
7,251,381 |
|
|
-- |
Inventory |
|
96,587 |
|
|
56,012 |
Prepaid expenses and other current assets |
|
1,881,266 |
|
|
1,649,781 |
Total current assets |
|
54,862,012 |
|
|
55,187,406 |
Investments |
|
4,991,600 |
|
|
5,008,243 |
Operating lease right-of-use asset |
|
1,074,020 |
|
|
-- |
Property and equipment, net |
|
140,320 |
|
|
245,425 |
Deposits |
|
8,888 |
|
|
8,888 |
Total assets |
$ |
61,076,840 |
|
$ |
60,449,962 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
2,940,086 |
|
$ |
2,337,367 |
Accrued expenses and other liabilities |
|
6,086,029 |
|
|
7,173,987 |
Total current liabilities |
|
9,026,115 |
|
|
9,511,354 |
Accrued expenses and other liabilities, non-current |
|
-- |
|
|
154,799 |
Operating lease liability, net of current portion |
|
875,098 |
|
|
-- |
Total liabilities |
|
9,901,213 |
|
|
9,666,153 |
|
|
|
|
Total stockholders’ equity |
|
51,175,627 |
|
|
50,783,809 |
Total liabilities and stockholders’ equity |
$ |
61,076,840 |
|
$ |
60,449,962 |
Investor Contact
Brian Korb
The Trout Group LLC
(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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