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 second quarter ended June 30, 2019 and provided a
corporate update.
“We are very pleased with the continued strength
of the commercial launch of Firdapse®, the first and only
evidence-based, FDA approved drug for the treatment of adult
patients with Lambert-Eaton myasthenic syndrome (LEMS). We are
greatly encouraged by the support we continue to receive from LEMS
patients and their healthcare providers,” said Patrick J. McEnany,
Chairman and Chief Executive Officer of Catalyst Pharmaceuticals.
“While the launch remains our greatest area of focus, we are also
enthused with the advances we continue to make with our ongoing
clinical programs, as well as our effort to expand our reach with
Firdapse to other countries without an approved therapy for
LEMS.”
Q2-19 Financial Results
- Product revenue, net in the second quarter 2019 was $28.8
million
- Reported net income of $11.0 million, or $0.11 per basic and
$0.10 per diluted share, in the second quarter of 2019, compared
with a net loss of $6.0 million, or $0.06 per basic and diluted
share, for the second quarter of 2018.
- Selling, general and administrative expenses for the second
quarter of 2019 totaled $9.0 million as compared to $2.6 million in
the second quarter of 2018.
- Research and development expenses for the second quarter of
2019 were $4.6 million as compared to $3.7 million for the second
quarter of 2018.
- Ended June 30, 2019 with $64.9 million in cash and investments
and no funded debt.
Recent Developments and
Highlights
- Initiated commercial launch of Firdapse for LEMS on January 15,
2019.
- Had 409 adult LEMS patients on Firdapse as of June 30, 2019,
compared to 337 patients on March 31, 2019.
- As of today, 138 patients previously naïve to any form of
3,4-DAP are enrolled in Catalyst Pathways.
- Amended our Firdapse license agreement to expand the commercial
territory to include Japan.
- Global expansion of Firdapse for LEMS underway in Canada and
Japan.
- Filed federal lawsuit against U.S. Food and Drug Administration
challenging the approval of RuzurgiTM for the treatment of
pediatric LEMS patients (ages 6 to under 17).
Upcoming Milestones
- Expect to complete enrollment for the MuSK-MG trial in the
second half of 2019 and to report top-line results from this trial
in the first half of 2020.
- 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 June 30, 2019, Catalyst
reported net income of $10,959,948, or $0.11 per basic and $0.10
per diluted share, compared to a net loss of $5,965,140, or $0.06
per basic and diluted share, for the same period in 2018. For the
six months ended June 30, 2019, Catalyst reported net income of
$10,315,445, or $0.10 per basic and diluted share, as compared to a
net loss of $11,665,032, or $0.11 per basic and diluted share, for
the same period in 2018.
Research and development expenses for the second
quarter of 2019 were $4,629,364 as compared to $3,704,824 in the
second quarter of 2018. For the six months ended June 30, 2019,
research and development expenses were $7,937,323 as compared to
$6,963,866 in the same period in 2018. Research and development
expenses for the three and six months ended June 30, 2019 primarily
consisted of expenses in 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 prepared to submit 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, CMS and SMA Type 3
and its Expanded Access Program for Firdapse.
Selling, general and administrative expenses for
the second quarter of 2019 totaled $8,987,722 as compared to
$2,631,031 in the second quarter of 2018. For the six months ended
June 30, 2019, selling, general and administrative expenses were
$17,404,182 as compared to $5,305,429 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, 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
suit against the FDA. The Company expects selling, general and
administrative expenses to increase in 2019, as the Company
continues to build its infrastructure and commercial and patient
programs in support of Firdapse sales activities in 2019, and
prosecutes its lawsuit against the FDA.
Catalyst launched its first product, Firdapse,
in January 2019. Product revenue, net for the quarter and six
months ended June 30, 2019 were $28,837,900 and $41,286,338,
respectively. Cost of sales for the quarter and six months ended
June 30, 2019 were $4,261,625 and $5,973,413, respectively.
At June 30, 2019, Catalyst had cash and cash
equivalents and investments of $64.9 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 August 7, 2019.
Conference Call
Catalyst management will host an
investment-community conference call and webcast at 8:30 a.m. ET,
tomorrow, Thursday, August 8, 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. Prior to its approval,
Firdapse for LEMS had received breakthrough therapy designation and
orphan drug designation from the FDA.
Firdapse is 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 myasthenia
gravis and CMS. 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, even if Catalyst is
successful in commercializing Firdapse, Catalyst will achieve
sustained profitability, (ii) the effect on Catalyst’s business and
future results of operations of the recent approval by the FDA of
Ruzurgi for the treatment of pediatric LEMS patients (ages 6 to
under 17); (iii) whether Catalyst's suit against the FDA seeking to
vacate the FDA's approval of Ruzurgi will be successful; (iv)
whether Firdapse will ever be approved for commercialization 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 June
30, |
|
For the Six MonthsEnded June
30, |
| |
|
2019 |
|
|
2018 |
|
|
|
2019 |
|
|
2018 |
|
| Product revenue,
net |
$ |
28,837,900 |
|
$ |
-- |
|
|
$ |
41,286,338 |
|
$ |
-- |
|
| |
|
|
|
|
|
|
|
| Operating costs and
expenses: |
|
|
|
|
|
|
|
| Cost of
sales |
|
4,261,625 |
|
|
-- |
|
|
|
5,973,413 |
|
|
-- |
|
| Research and
development |
|
4,629,364 |
|
|
3,704,824 |
|
|
|
7,937,323 |
|
|
6,963,866 |
|
| Selling, general and
administrative |
|
8,987,722 |
|
|
2,631,031 |
|
|
|
17,404,182 |
|
|
5,305,429 |
|
| Total
operating costs and expenses |
|
17,878,711 |
|
|
6,335,855 |
|
|
|
31,314,918 |
|
|
12,269,295 |
|
| Operating income
(loss) |
|
10,959,189 |
|
|
(6,335,855 |
) |
|
|
9,971,420 |
|
|
(12,269,295 |
) |
| Other income, net |
|
450,410 |
|
|
370,715 |
|
|
|
793,676 |
|
|
604,263 |
|
| Net income (loss)
before income taxes |
|
11,409,599 |
|
|
(5,965,140 |
) |
|
|
10,765,096 |
|
|
(11,665,032 |
) |
| Provision for income
taxes |
|
449,651 |
|
|
-- |
|
|
|
449,651 |
|
|
-- |
|
| Net income
(loss) |
$ |
10,959,948 |
|
$ |
(5,965,140 |
) |
|
$ |
10,315,445 |
|
$ |
(11,665,032 |
) |
| |
|
|
|
|
|
|
|
| Net income (loss) per
share: |
|
|
|
|
|
|
|
| Basic |
$ |
0.11 |
|
$ |
(0.06 |
) |
|
$ |
0.10 |
|
$ |
(0.11 |
) |
| Diluted |
$ |
0.10 |
|
$ |
(0.06 |
) |
|
$ |
0.10 |
|
$ |
(0.11 |
) |
| |
|
|
|
|
|
|
|
| Weighted average shares
outstanding: |
|
|
|
|
|
|
|
| Basic |
|
102,869,202 |
|
|
102,596,446 |
|
|
|
102,808,897 |
|
|
102,577,005 |
|
| Diluted |
|
105,928,970 |
|
|
102,596,446 |
|
|
|
105,098,930 |
|
|
102,577,005 |
|
|
CATALYST PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
|
June 30,
2019 |
|
December 31,
2018 |
|
|
(unaudited) |
|
|
|
ASSETS |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and cash equivalents |
$ |
23,417,512 |
|
$ |
16,559,400 |
|
Short-term investments |
|
36,503,442 |
|
|
36,922,213 |
|
Accounts receivable, net |
|
10,376,427 |
|
|
-- |
|
Inventory |
|
269,879 |
|
|
56,012 |
|
Prepaid expenses and other current assets |
|
1,488,603 |
|
|
1,649,781 |
|
Total current assets |
|
72,055,863 |
|
|
55,187,406 |
|
Investments |
|
5,008,400 |
|
|
5,008,243 |
|
Operating lease right-of-use asset |
|
1,013,590 |
|
|
-- |
|
Property and equipment, net |
|
147,619 |
|
|
245,425 |
|
Deposits |
|
8,888 |
|
|
8,888 |
|
Total assets |
$ |
78,234,360 |
|
$ |
60,449,962 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
$ |
3,328,726 |
|
$ |
2,337,367 |
|
Accrued expenses and other liabilities |
|
10,822,803 |
|
|
7,173,987 |
|
Total current liabilities |
|
14,151,529 |
|
|
9,511,354 |
|
Accrued expenses and other liabilities, non-current |
|
-- |
|
|
154,799 |
|
Operating lease liability, net of current portion |
|
801,264 |
|
|
-- |
|
Total liabilities |
|
14,952,793 |
|
|
9,666,153 |
|
|
|
|
|
|
Total stockholders’ equity |
|
63,281,567 |
|
|
50,783,809 |
|
Total liabilities and stockholders’ equity |
$ |
78,234,360 |
|
$ |
60,449,962 |
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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