Company to Host Quarterly Conference Call
at 8:30 am ET Tomorrow
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
third quarter ended September 30, 2018 and provided a corporate
update.
“We are extremely focused on executing on our
launch-readiness plan as we prepare for the potential commercial
launch of Firdapse® for the treatment of Lambert-Eaton Myasthenic
Syndrome (LEMS) early next year,” said Patrick J. McEnany, Chairman
and Chief Executive Officer of Catalyst Pharmaceuticals, Inc. “We
were also pleased to announce the expansion of our clinical
leadership team with the hiring of Stanley Iyadurai, M.D., Ph.D.,
as our Vice President of Clinical Development, to assist us in
accelerating and managing our clinical programs as we continue to
evaluate Firdapse in the treatment of other potential neuromuscular
indications. We believe we are well positioned to achieve our
vision of positively impacting lives of patients living with rare
neuromuscular diseases as we continue to build our rare disease
company.”
Q3-18 and Other Recent Highlights
- Continued progress with pre-commercialization activities for a
potential launch of Firdapse in early 2019
- Appointed Dr. Stanley Iyadurai as VP of Clinical
Development
- Recently added three additional medical science liaisons to our
medical affairs team
- Number of current FTEs is 37 as compared to 18 at the beginning
of this year
- FDA Acceptance of NDA and Priority Review Status for Firdapse
for LEMS
- Ended the third quarter with $66.7 million in cash and
investments and no debt
Upcoming Milestones
- Prescription Drug User Fee Act (PDUFA) goal date of November
28, 2018 for Firdapse for LEMS
- Potential launch of Firdapse for LEMS in early 2019
- Enroll first patients in SMA Type 3 proof of concept study
- Complete enrollment in CMS Phase 3 trial
- Expect top-line results from Phase 3 CMS (CMS-001) trial in the
second half of 2019
- Expect top-line results from Phase 3 trial for MuSK-MG in the
second half of 2019
Financial Results
For the quarter ended September 30, 2018,
Catalyst reported a GAAP net loss of $7,838,873, or $0.08 per basic
and diluted share, compared to a GAAP net loss of $4,177,649, or
$0.05 per basic and diluted share, for the same period in 2017. For
the third quarter of 2018 and 2017, Non-GAAP1 net loss was the same
as GAAP net loss as there were no Non-GAAP1 adjustments.
For the nine months ended September 30, 2018,
Catalyst reported a GAAP net loss of $19,503,905, or $0.19 per
basic and diluted share, as compared to a GAAP net loss of
$13,024,679, or $0.16 per basic and diluted share, for the same
period in 2017. For the nine months ended September 30, 2018, 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
first nine months of 2017 was $12,837,775, or $0.15 per basic and
diluted share, which excludes non-cash loss of $186,904
attributable to the change in fair value of liability-classified
warrants.
Research and development expenses for the third
quarter of 2018 were $4,538,369 compared to $2,704,923 in the third
quarter of 2017. For the nine months ended September 30, 2018,
research and development expenses were $11,502,235 as compared to
$7,970,603 in the same period in 2017. The increase in research and
development expenses for the nine months ended September 30, 2018
when compared to the same period in 2017 is primarily due to
increases in consulting expenses as Catalyst prepared to submit its
NDA for Firdapse during the first quarter of 2018, milestone
expenses relating to the acceptance of Catalyst’s NDA submission in
May 2018, expenses from Catalyst’s medical affairs program, and
compensation and related personnel costs as Catalyst expands its
headcount to support its currently ongoing trials and
programs. Catalyst expects that costs related to research and
development activities will continue to be substantial during the
balance of 2018 as Catalyst works towards completing trials
evaluating Firdapse for the treatment of CMS, MuSK-MG and SMA Type
3, continues its Expanded Access Program for Firdapse and its other
development programs, and prosecutes its NDA submission for
Firdapse for LEMS.
General and administrative expenses for the
third quarter of 2018 totaled $3,644,234 as compared to $1,601,785
in the third quarter of 2017. For the nine months ended September
30, 2018, general and administrative expenses were $8,949,663 as
compared to $5,197,247 in the same period in 2017. The increase
when compared to the same period in 2017 is primarily due to
increases in pre-commercialization expenses and headcount, and
corporate expenses as Catalyst builds up its infrastructure and
commercial programs in preparation for a potential launch of
Firdapse in 2019. Catalyst expects general and administrative
expenses, including pre-commercialization expenses, to continue to
increase in 2018 as Catalyst continues to expand its operations in
preparation for a potential launch of Firdapse in 2019.
As a development-stage biopharmaceutical
company, Catalyst had no revenues in either the third quarter of
2018 and 2017 or the first nine months of 2018 and 2017.
At September 30, 2018, Catalyst had cash and
investments of $66.7 million and no debt. Catalyst believes that
its existing capital resources will be sufficient to support its
planned 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
may be found in the Company's Quarterly Report on Form 10-Q, which
was filed with the Securities and Exchange Commission (SEC) on
November 7, 2018.
_________________________
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.
Conference Call
Catalyst management will host an
investment-community conference call and webcast at 8:30 a.m. ET,
tomorrow, Thursday, November 8, 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 spinal muscular atrophy
(SMA) type 3. Firdapse® (amifampridine phosphate) 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 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 Firdapse will ever be
approved for commercialization, (ii) whether, even if Firdapse is
approved for commercialization, Catalyst will be successful in
commercializing Firdapse, (iii) 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 (iv) 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.
|
|
|
CATALYST PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited) |
|
|
|
|
For the Three Months
Ended September 30, |
For the Nine Months
Ended September 30, |
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
4,538,369 |
|
|
$ |
2,704,923 |
|
|
$ |
11,502,235 |
|
|
$ |
7,970,603 |
|
General
and administrative |
|
3,644,234 |
|
|
|
1,601,785 |
|
|
|
8,949,663 |
|
|
|
5,197,247 |
|
Total
operating costs and expenses |
|
8,182,603 |
|
|
|
4,306,708 |
|
|
|
20,451,898 |
|
|
|
13,167,850 |
|
Loss from
operations |
|
(8,182,603 |
) |
|
|
(4,306,708 |
) |
|
|
(20,451,898 |
) |
|
|
(13,167,850 |
) |
Other
income, net |
|
343,730 |
|
|
|
129,059 |
|
|
|
947,993 |
|
|
|
330,075 |
|
Change
in fair value of warrants liability |
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
(186,904 |
) |
Loss
before income taxes |
|
(7,838,873 |
) |
|
|
(4,177,649 |
) |
|
|
(19,503,905 |
) |
|
|
(13,024,679 |
) |
Provision for income taxes |
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
Net
loss |
$ |
(7,838,873 |
) |
|
$ |
(4,177,649 |
) |
|
$ |
(19,503,905 |
) |
|
$ |
(13,024,679 |
) |
Net loss
per share – basic and diluted |
$ |
(0.08 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.16 |
) |
Weighted
average shares outstanding – basic and diluted |
|
102,641,504 |
|
|
|
84,797,969 |
|
|
|
102,598,740 |
|
|
|
83,898,724 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
2018 |
|
|
2017 |
ASSETS |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
Cash and
cash equivalents |
$ |
10,616,313 |
|
$ |
57,496,702 |
Short-term investments |
|
51,047,842 |
|
|
26,516,711 |
Prepaid
expenses and other current assets |
|
816,820 |
|
|
1,173,744 |
Total
current assets |
|
62,480,975 |
|
|
85,187,157 |
Investments |
|
5,018,857 |
|
|
-- |
Property
and equipment, net |
|
201,093 |
|
|
191,385 |
Deposits |
|
8,888 |
|
|
8,888 |
Total
assets |
$ |
67,709,813 |
|
$ |
85,387,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
Accounts
payable |
$ |
1,340,984 |
|
$ |
1,945,575 |
Accrued
expenses and other liabilities |
|
2,127,450 |
|
|
2,320,587 |
Total
current liabilities |
|
3,468,434 |
|
|
4,266,162 |
|
|
|
|
|
|
Accrued expenses and
other liabilities, non-current |
|
164,781 |
|
|
157,456 |
Total
liabilities |
|
3,633,215 |
|
|
4,423,618 |
|
|
|
|
|
|
Total stockholders’
equity |
|
64,076,598 |
|
|
80,963,812 |
Total liabilities and
stockholders’ equity |
$ |
67,709,813 |
|
$ |
85,387,430 |
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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