--Firdapse® NDA to be Resubmitted Before the End
of this Quarter
Catalyst Pharmaceuticals, Inc. (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
fourth quarter and year-ended December 31, 2017.
“Throughout 2017, we made significant progress
in successfully completing our second Phase 3 trial evaluating
Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome
(LEMS) and successfully completing the required abuse liability
studies that confirmed that Firdapse does not exhibit abuse
potential. We also continued to build our rare neuromuscular
disease platform as we prepared to enroll subjects in our Phase 3
clinical trial for MuSK antibody positive myasthenia gravis and our
proof-of-concept clinical trial for spinal muscular atrophy Type
3,” said Patrick J. McEnany, Chairman and Chief Executive Officer
of Catalyst Pharmaceuticals, Inc. “We remain on track to resubmit
our NDA for Firdapse this quarter, and we are actively engaged in
pre-commercialization activities for a potential launch of
Firdapse.”
2017 and Recent Highlights
- Announced top-line results in LMS-003 trial, reaching both
primary and secondary endpoints and completed required abuse
liability studies
- Announced positive data from investigator-sponsored trial of
Firdapse in treating MuSK antibody positive Myasthenia Gravis
- Confirmed timeline for NDA resubmission for Firdapse expected
first quarter of 2018 following a positive Type C meeting recently
held with the FDA
- Announced Phase 2 study of Firdapse in ambulatory patients with
Spinal Muscular Atrophy (SMA) Type 3
- Reached an agreement with the FDA under SPA for Phase 3
Firdapse in MuSK-MG trial
- Reinitiated pre-commercialization activities for a potential
launch of Firdapse
- Raised $53.8M in net proceeds from a public offering in
November
- Ended December 31, 2017 with $84.0
million in cash and investments and no debt
Upcoming Milestones
- Resubmit NDA for Firdapse in the first quarter of 2018
- Enroll first subject in Phase 3 trial for MuSK-MG in H1
2018
- Enroll first subject in SMA Type 3 proof of concept trial in
the second quarter of 2018
- Expect to complete enrollment in the Phase 3 CMS (CMS-001)
trial before the end of 2018 and to report top-line results from
this trial in the first quarter of 2019
Fourth Quarter and Full-Year 2017 Financial
Results
For the year ended December 31, 2017,
Catalyst reported a GAAP net loss of $18,412,377, or $0.21 per
basic and diluted share, compared to a GAAP net loss of
$18,072,452, or $0.22 per basic and diluted share, for the 2016
fiscal year. Excluding non-cash loss of $186,904 attributable to
the change in fair value of liability-classified warrants,
Non-GAAP1 net loss was $18,225,473, or $0.21 per basic and diluted
share, for the year ended December 31, 2017. In comparison,
Non-GAAP1 net loss for the year ended December 31, 2016 was
$18,958,589, or $0.23 per basic and diluted share, which excludes
non-cash gain of $886,137 attributable to the change in fair value
of liability-classified warrants.
For the quarter ended December 31, 2017,
Catalyst reported a GAAP net loss of $5,387,698, or $0.06 per basic
and diluted share, compared to a GAAP net loss of $4,163,320, or
$0.05 per basic and diluted share, for the 2016 fiscal year. For
the fourth quarter of 2017, Non-GAAP1 net loss was the same as GAAP
net loss as there were no Non-GAAP1 adjustments. In comparison,
Non-GAAP1 net loss for the fourth quarter of 2016 was $4,270,266,
or $0.05 per basic and diluted share, which excludes non-cash
gain of $106,946 attributable to the change in fair value of
liability-classified warrants.
Research and development expenses for the year
ended December 31, 2017 were $11,375,237, compared to
$11,369,941 for the 2016 fiscal year. For the fourth quarter of
2017, research and development expenses were $3,404,634, compared
to $2,820,654 for the fourth quarter of 2016. Research and
development expenses in 2017 were consistent with amounts expended
in 2016, and included expenses related to ongoing studies and
trials for Firdapse, the costs of Catalyst's Firdapse Expanded
Access Program, and costs of Catalyst's CPP-115 and generic Sabril®
programs. Catalyst expects that its R&D spend for 2018 will
continue to be substantial as Catalyst completes its clinical trial
for CMS, continues its Expanded Access Program, continues its
clinical programs for MuSK-MG and SMA Type 3, prepares the NDA
submission for Firdapse, and manufactures Firdapse launch
supplies.
General and administrative expenses for the year
ended December 31, 2017 totaled $7,304,399, compared to $7,910,260
in the 2016 fiscal year. For the fourth quarter of 2017, general
and administrative expenses totaled $2,107,152, compared to
$1,493,545 in the same period in 2016. The decrease in general and
administrative expenses from 2017 to 2016 was primarily due to
Catalyst's efforts to conserve cash after the receipt of the FDA’s
“refusal to file letter” for Firdapse. Catalyst expects that
general and administrative costs will increase in 2018, as Catalyst
prepares for the commercialization of Firdapse.
Catalyst had no revenues in the year 2017 or
2016.
At December 31, 2017, Catalyst had cash and
investments of $84 million and no debt. Based on its
current financial position and its forecasts of available cash,
Catalyst believes that it has sufficient funds to support its
operations through 2019 (without considering revenues and cash
receipts that may be received in 2019 if Catalyst is successful in
obtaining an approval of Firdapse and launching the product in
2019, of which there can be no assurance).
More detailed financial information and analysis
can be found in Catalyst's Annual Report on Form 10-K for the
fiscal year ended December 31, 2017, which was filed with
the Securities and Exchange Commission, earlier today, March
14, 2018.
Conference Call
Catalyst management will host an
investment-community conference call and webcast at 5:00 p.m.
ET, today, Wednesday, March 14, 2018 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), congenital myasthenic syndromes (CMS), MuSK
antibody positive myasthenia gravis, and infantile spasms.
Firdapse® has received Breakthrough Therapy Designation from the
U.S. Food and Drug Administration (FDA) for the treatment of LEMS
and Orphan Drug Designation for LEMS, CMS and myasthenia gravis.
Firdapse is the first and only approved drug in Europe for
symptomatic treatment in adults with LEMS.
Catalyst is also developing CPP-115 to treat
refractory infantile spasms. CPP-115 has been granted U.S. Orphan
Drug Designation for the treatment of infantile spasms by the FDA
and has been granted E.U. Orphan Medicinal Product Designation for
the treatment of West syndrome by the European Commission. In
addition, Catalyst is developing a generic version of Sabril®
(vigabatrin).
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 results of the LMS-003
trial, combined with the results of the Company's previous Phase 3
trial, will be acceptable to the FDA as support for an approval of
Firdapse for the treatment of LEMS, (ii) whether the results of the
abuse liability studies undertaken by Catalyst will be acceptable
to the FDA as support for an approval of Firdapse, (iii) whether
any NDA submitted for Firdapse will be accepted by the FDA, and the
timing of any such submission and acceptance, (iv) whether the
receipt of breakthrough therapy designation for Firdapse will
expedite the development and review of Firdapse by the FDA or the
likelihood that the product will be found to be safe and effective,
(v) whether, if an NDA for Firdapse is accepted for filing, such
NDA will be given a priority review by the FDA, (vi) whether
Firdapse will ever be approved for commercialization, (vii) whether
Catalyst will be the first company to receive an approval for
amifampridine (3,4-DAP), giving it 5-year marketing exclusivity for
its product, and (viii) those other factors described in Catalyst's
Annual Report on Form 10-K for the fiscal year 2017 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.
_________________________ 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
loss the expense (or the income) associated with the change in fair
value of the liability-classified warrants. Non-GAAP net loss
per share is calculated by dividing non-GAAP net loss by the
weighted average common shares outstanding.
CATALYST PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
|
For the Three
Months Ended December 31, |
|
For the YearEnded December
31, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
$ |
3,404,634 |
|
|
$ |
2,820,654 |
|
|
$ |
11,375,237 |
|
|
$ |
11,369,941 |
|
|
General
and administrative |
|
2,107,152 |
|
|
|
1,493,545 |
|
|
|
7,304,399 |
|
|
|
7,910,260 |
|
|
Total
operating costs and expenses |
|
5,511,786 |
|
|
|
4,314,199 |
|
|
|
18,679,636 |
|
|
|
19,280,201 |
|
|
Loss from
operations |
|
(5,511,786 |
) |
|
|
(4,314,199 |
) |
|
|
(18,679,636 |
) |
|
|
(19,280,201 |
) |
|
Other income,
net |
|
124,088 |
|
|
|
43,933 |
|
|
|
454,163 |
|
|
|
321,612 |
|
|
Change in fair value of
warrants liability |
|
- |
|
|
|
106,946 |
|
|
|
(186,904 |
) |
|
|
886,137 |
|
|
Loss
before income taxes |
|
(5,387,698 |
) |
|
|
(4,163,320 |
) |
|
|
(18,412,377 |
) |
|
|
(18,072,452 |
) |
|
Provision for income
taxes |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Net
loss |
$ |
(5,387,698 |
) |
|
$ |
(4,163,320 |
) |
|
$ |
(18,412,377 |
) |
|
$ |
(18,072,452 |
) |
|
Net loss per share –
basic and diluted |
$ |
(0.06 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.22 |
) |
|
Weighted average
shares outstanding – basic and diluted |
|
91,451,695 |
|
|
|
82,899,526 |
|
|
|
85,802,487 |
|
|
|
82,875,281 |
|
|
|
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|
December 31,
2017 |
|
December 31, 2016 |
|
|
|
|
ASSETS |
|
|
|
Current
Assets: |
|
|
|
Cash and
cash equivalents |
$ |
57,496,702 |
|
$ |
13,893,064 |
Short-term investments |
|
26,516,711 |
|
|
26,512,753 |
Prepaid
expenses and other current assets |
|
1,173,744 |
|
|
1,047,944 |
Total
current assets |
|
85,187,157 |
|
|
41,453,761 |
Property
and equipment, net |
|
191,385 |
|
|
244,204 |
Deposits |
|
8,888 |
|
|
8,888 |
Total
assets |
$ |
85,387,430 |
|
$ |
41,706,853 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
Liabilities: |
|
|
|
Accounts
payable |
$ |
1,945,575 |
|
$ |
933,176 |
Accrued
expenses and other liabilities |
|
2,320,587 |
|
|
1,161,359 |
Total
current liabilities |
|
4,266,162 |
|
|
2,094,535 |
Accrued expenses and other liabilities, non-current |
|
157,456 |
|
|
181,162 |
Warrants liability, at fair value |
|
- |
|
|
122,226 |
Total
liabilities |
|
4,423,618 |
|
|
2,397,923 |
|
|
|
|
Total stockholders’ equity |
|
80,963,812 |
|
|
39,308,930 |
Total
liabilities and stockholders’ equity |
$ |
85,387,430 |
|
$ |
41,706,853 |
Investor Contact
Brian Korb
The Trout Group LLC
(646) 378-2923
bkorb@troutgroup.com
Media Contact
David Schull
Russo Partners
(212) 845-4271
david.schull@russopartnersllc.com
Company Contact
Patrick J. McEnany
Catalyst Pharmaceuticals
Chief Executive Officer
(305) 420-3200
pmcenany@catalystpharma.com
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