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 third quarter ended
September 30, 2019 and provided a corporate update.
“We are pleased with the continued strength of
our commercial launch for Firdapse® in adult LEMS patients and are
very encouraged by the feedback we have received from LEMS
patients, including high levels of satisfaction regarding their
treatment journey through Catalyst Pathways™, our patient
assistance program,” said Patrick J. McEnany, Chairman and Chief
Executive Officer of Catalyst Pharmaceuticals. “While the U.S.
launch of Firdapse remains our primary focus, we have made
significant progress on our other strategic priorities. These
include our recent filing of a New Drug Submission (NDS) for
Firdapse with Health Canada, for which we have been granted a
Priority Review. In addition, we recently met with Japanese
regulatory authorities about registration requirements to obtain
approval of Firdapse for Japan. Our team has done an excellent job
in executing our business plan this year, and we are on track to
meet all of our goals and objectives for 2019 as we move into the
new year.”
Q3-19 Financial Results
- Reported product revenue, net in the third quarter 2019 of
$30.9 million
- Reported net income of $13.6 million, or $0.13 per basic and
diluted share, in the third quarter of 2019, compared with a net
loss of $7.8 million, or $0.08 per basic and diluted share, for the
third quarter of 2018
- Selling, general and administrative expenses for the third
quarter of 2019 totaled $8.1 million as compared to $3.6 million in
the third quarter of 2018
- Research and development expenses for the third quarter of 2019
were $4.6 million as compared to $4.5 million for the third quarter
of 2018
- Ended September 30, 2019 with $81.6 million in cash and
investments and no funded debt
Recent Developments and
Highlights
- Reported a total of 494 cumulative Firdapse unique patient
enrollments at the end of the third quarter since commercial launch
at beginning of year
- Reported that over 170 patients previously naïve to any form of
3,4-DAP were enrolled in Catalyst Pathways at the end of the third
quarter
- Over 370 patients actively receiving an insurance-reimbursed
Firdapse prescription at the end of the third quarter
- Announced top-line results from CMS-001 Phase 3 trial of
Firdapse for CMS
- Continued with global expansion efforts of Firdapse for LEMS
with recent meetings with Japanese regulatory authorities to
discuss regulatory path forward in Japan
- Recently filed New Drug Submission (NDS) with Health Canada for
Firdapse to treat LEMS and have been granted a Priority Review
Revenue Guidance
- The Company expects full-year 2019 net revenues to be
approximately $100 million
- The Company expects full-year 2020 net revenues to be in the
range of $135 million to $155 million
- Both the 2019 and the 2020 net revenue forecast assume only
sales of Firdapse for the treatment of adult LEMS patients
Upcoming Milestones
- Expect to meet with the FDA before year-end to discuss CMS-001
study outcome and path forward
- Expect to report top-line results from Phase 3 trial for
MuSK-MG in the first half of 2020
- Expect to report top-line results from the SMA Type 3 proof of
concept trial in the first half of 2020
Financial Results
For the quarter ended September 30, 2019,
Catalyst reported net income of $13,630,179, or $0.13 per basic and
diluted share, compared to a net loss of $7,838,873, or $0.08 per
basic and diluted share, for the same period in 2018. For the nine
months ended September 30, 2019, Catalyst reported net income of
$23,945,624, or $0.23 per basic and diluted share, as compared to a
net loss of $19,503,905, or $0.19 per basic and diluted share, for
the same period in 2018.
Catalyst launched its first product, Firdapse,
in January 2019. Product revenue, net for the quarter and nine
months ended September 30, 2019 were $30,897,444 and $72,183,782,
respectively. Cost of sales for the quarter and nine months ended
September 30, 2019 were $4,387,461 and $10,360,874,
respectively.
Research and development expenses for the third
quarter of 2019 were $4,597,039 as compared to $4,538,369 in the
third quarter of 2018. For the nine months ended September 30,
2019, research and development expenses were $12,534,362 as
compared to $11,502,235 in the same period in 2018. Research and
development expenses for the three and nine months ended September
30, 2019 primarily consisted of expenses for medical and regulatory
affairs and quality assurance programs, as well as expenses from
our ongoing clinical trials and studies evaluating Firdapse for the
treatment of other ultra-orphan neuromuscular diseases and our
Expanded Access Program. Research and development expenses in
the comparable period in 2018, primarily consisted of consulting
expenses as the Company submitted an NDA for Firdapse for the
treatment of LEMS, as well as expenses from Catalyst's ongoing
clinical trials and studies and its 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 and
SMA Type 3 and its Expanded Access Program for Firdapse.
Selling, general and administrative expenses for
the third quarter of 2019 totaled $8,067,792 as compared to
$3,644,234 in the third quarter of 2018. For the nine months ended
September 30, 2019, selling, general and administrative expenses
were $25,471,974 as compared to $8,949,663 in the same period in
2018. The increase when compared to the same period in 2018 is
primarily due to increased selling expenses, including costs of
commercial system implementation, expansion of the Company's sales
force and supporting personnel, product launch expenses, market
access and market research expenses, and professional fees
associated with Catalyst’s lawsuit against the FDA. The Company
expects selling, general and administrative expenses to increase in
2019 and into 2020, as the Company continues to build its
infrastructure and commercial and patient programs in support of
Firdapse sales activities and pursues its lawsuit against the
FDA.
At September 30, 2019, Catalyst had cash and
cash equivalents and investments of $81.6 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
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 November 12, 2019.
Conference Call
Catalyst management will host an
investment-community conference call and webcast at 8:30 a.m. ET,
tomorrow, Wednesday, November 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 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.
Firdapse is 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 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 the Company's forecast for
net revenue in full year 2019 and full year 2020 will prove
correct, (ii) whether Catalyst can successfully increase sales of
Firdapse through expansion of its sales personnel from current
levels, (iii) whether, even if Catalyst achieves its forecasted net
revenue targets, it will remain profitable, (iv) whether Catalyst
will be able to compete successfully for adult LEMS patients
against off-label use of Ruzurgi® (which is priced lower than
Firdapse), (v) whether payors will, in the future, require that
patients try off-label Ruzurgi® first before such payors will
approve Firdapse as a treatment for adult LEMS patients (vi)
whether Catalyst’s NDS for Firdapse filed with Health Canada will
be accepted for filing, and even if it is accepted for filing,
whether it will be approved; (vii) whether Firdapse will ever be
approved for the treatment of CMS, MuSK-MG, SMA Type 3, or any
other disease, and (viii) 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.
Investors are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date made.
While Catalyst may voluntarily do so from time to time, Catalyst
undertakes no commitment to update forward-looking statements,
whether as a result of new information, future events or otherwise,
except as may be required by applicable securities laws.
CATALYST PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
|
For the Three Months Ended September
30, |
|
For the Nine MonthsEnded September
30, |
|
|
|
2019 |
|
|
2018 |
|
|
|
2019 |
|
|
2018 |
|
Product revenue, net. |
$ |
30,897,444 |
|
$ |
-- |
|
|
$ |
72,183,782 |
|
$ |
-- |
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
Cost of sales |
|
4,387,461 |
|
|
-- |
|
|
|
10,360,874 |
|
|
-- |
|
Research and
development |
|
4,597,039 |
|
|
4,538,369 |
|
|
|
12,534,362 |
|
|
11,502,235 |
|
Selling, general and
administrative |
|
8,067,792 |
|
|
3,644,234 |
|
|
|
25,471,974 |
|
|
8,949,663 |
|
Total operating costs
and expenses |
|
17,052,292 |
|
|
8,182,603 |
|
|
|
48,367,210 |
|
|
20,451,898 |
|
Operating income (loss) |
|
13,845,152 |
|
|
(8,182,603 |
) |
|
|
23,816,572 |
|
|
(20,451,898 |
) |
Other income, net |
|
393,415 |
|
|
343,730 |
|
|
|
1,187,091 |
|
|
947,993 |
|
Net income (loss)
before income taxes |
|
14,238,567 |
|
|
(7,838,873 |
) |
|
|
25,003,663 |
|
|
(19,503,905 |
) |
Provision for income
taxes |
|
608,388 |
|
|
-- |
|
|
|
1,058,039 |
|
|
-- |
|
Net income (loss) |
$ |
13,630,179 |
|
$ |
(7,838,873 |
) |
|
$ |
23,945,624 |
|
$ |
(19,503,905 |
) |
|
|
|
|
|
|
|
|
Net income (loss) per
share: |
|
|
|
|
|
|
|
Basic |
$ |
0.13 |
|
$ |
(0.08 |
) |
|
$ |
0.23 |
|
$ |
(0.19 |
) |
Diluted |
$ |
0.13 |
|
$ |
(0.08 |
) |
|
$ |
0.23 |
|
$ |
(0.19 |
) |
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
102,974,105 |
|
|
102,641,504 |
|
|
|
102,864,571 |
|
|
102,598,740 |
|
Diluted |
|
107,045,234 |
|
|
102,641,504 |
|
|
|
105,821,609 |
|
|
102,598,740 |
|
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|
September 30, 2019 |
|
December 31, 2018 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
44,983,218 |
|
$ |
16,559,400 |
Short-term investments |
|
31,561,673 |
|
|
36,922,213 |
Accounts receivable, net |
|
10,095,352 |
|
|
-- |
Inventory |
|
599,801 |
|
|
56,012 |
Prepaid expenses and other current assets |
|
3,339,399 |
|
|
1,649,781 |
Total current assets |
|
90,579,443 |
|
|
55,187,406 |
Investments |
|
5,008,800 |
|
|
5,008,243 |
Operating lease right-of-use asset |
|
952,340 |
|
|
-- |
Property and equipment, net |
|
141,088 |
|
|
245,425 |
Deposits |
|
8,888 |
|
|
8,888 |
Total assets |
$ |
96,690,559 |
|
$ |
60,449,962 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
4,147,029 |
|
$ |
2,337,367 |
Accrued expenses and other liabilities |
|
13,835,292 |
|
|
7,173,987 |
Total current liabilities |
|
17,982,321 |
|
|
9,511,354 |
Accrued expenses and other liabilities, non-current |
|
-- |
|
|
154,799 |
Operating lease liability, net of current portion |
|
725,700 |
|
|
-- |
Total liabilities |
|
18,708,021 |
|
|
9,666,153 |
|
|
|
|
Total stockholders’ equity |
|
77,982,538 |
|
|
50,783,809 |
Total liabilities and stockholders’ equity |
$ |
96,690,559 |
|
$ |
60,449,962 |
Investor Contact
Brian Korb
Solebury Trout
(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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