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 fourth quarter and
year-ended December 31, 2019 and provided a corporate update.
Patrick J. McEnany, Catalyst’s Chairman and CEO,
stated: "2019 was an outstanding year for Catalyst as we evolved
into a commercial-stage pharmaceutical company and successfully
launched Firdapse® (amifampridine) tablets 10 mg in the U.S. for
the treatment of adult LEMS patients. I am very proud of our
patient-centric team’s performance and it is inspiring to see how
we are improving the lives of LEMS patients every day." Mr. McEnany
continued: “Catalyst has exceeded all expectations for product
revenues and the number of patients who are currently being treated
with Firdapse. We remain dedicated to expanding our label for
Firdapse to include other neuromuscular conditions, including
MuSK-MG where we expect to report top-line data in the second
quarter of this year.”
Mr. McEnany continued: “In the face of the
coronavirus Covid-19 outbreak, we have been asked by patients,
healthcare providers and investors about our ability to provide a
continuous uninterrupted supply of Firdapse. Let me reassure you
that we are well prepared and well-stocked for any contingencies.
Our API (active pharmaceutical ingredients) and finished dosage
form are sourced from U.S. manufacturers, which are some of the
largest in the world. We also have a qualified second U.S.
manufacturer of our finished dosage form, if ever required.
Finally, as of today we have more than an adequate supply of
Firdapse ready for shipment in the warehouse to meet patients'
needs through the end of this year. We currently have a campaign
underway that will within the next two weeks provide another six
months of inventory beyond December. Our supply chain and safety
stock are solid.”
Q4-19 and FY-19 Financial
Results
- Reported product revenue, net of $30.1 million in the fourth
quarter 2019 and $102.3 million for the full year 2019
- Reported net income of $31.9 million for the 2019 year ($0.31
per basic share and $0.30 per diluted share), compared with a net
loss of $34.0 million ($0.33 per basic and diluted share) for the
year 2018
- Selling, general and administrative expenses for the fourth
quarter of 2019 totaled $11.4 million as compared to $6.9 million
in the fourth quarter of 2018
- Research and development expenses for the fourth quarter of
2019 were $6.3 million as compared to $8.4 million for the fourth
quarter of 2018
- Ended December 31, 2019 with $94.5 million in cash and
investments and no funded debt
Recent Developments and
Highlights
- Reported a total of 532 cumulative Firdapse patient enrollments
at the end of 2019 since commercial launch in January 2019
- Reported that over 190 patients previously naïve to any form of
3,4-DAP were enrolled in Catalyst Pathways™ at the end of the
fourth quarter
- Completed enrollment in pivotal Phase 3 anti-MuSK antibody
positive Myasthenia Gravis trial
- Over 345 patients actively receiving an insurance reimbursed
Firdapse prescription at the end of 2019
- Ongoing commercial expansion, including growth in sales and
marketing departments
- 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 2020 Firdapse net revenues to be
in the range of $135 million to $155 million
Upcoming Milestones
- Expect to report top-line results from Phase 3 trial for
MuSK-MG in the second quarter of 2020
- Expect to report top-line results from the SMA Type 3 proof of
concept trial in the second quarter of 2020
- Expect potential approval of New Drug Submission (NDS) for
Firdapse to treat LEMS in Canada in the second half of 2020
- Assuming the MuSK-MG trial is successful, we hope to submit a
supplemental NDA for Firdapse for MuSK-MG around the end of
2020
Financial ResultsFor fiscal
year ended December 31, 2019, Catalyst reported GAAP net
income of $31,875,337, or $0.31 per basic share and $0.30 per
diluted share, compared to a GAAP net loss of $34,003,514, or $0.33
per basic and diluted share, for the 2018 fiscal year. Excluding
expenses related to stock-based compensation of $3,824,815,
non-GAAP1 net income for the fiscal year ended December 31, 2019
was $35,700,152, or $0.35 per basic share and $0.34 per diluted
share. This compares to a non-GAAP1 net loss of $30,452,870, or
$0.30 per basic and diluted share, excluding stock-based
compensation expense of $3,550,644, for the 2018 fiscal year.
_________________________
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 income (loss) the
expense associated with non-cash stock-based compensation. Non-GAAP
income (loss) per share is calculated by dividing non-GAAP income
(loss) by the weighted average common shares outstanding.
Catalyst launched its first product, Firdapse,
in January 2019. Product revenue, net for the quarter and year
ended December 31, 2019 were $30,122,555 and $102,306,337,
respectively. Cost of sales for the quarter and year ended December
31, 2019 were $4,398,265 and $14,759,139, respectively. During
fourth quarter and fiscal year 2018, Catalyst had no revenues from
product sales and revenues from collaboration agreements of
$500,000 from its collaboration with Endo for generic Sabril.
For the quarter ended December 31, 2019,
Catalyst reported GAAP net income of $7,929,713, or $0.08 per basic
share and $0.07 per diluted share, compared to a GAAP net loss of
$14,499,609, or $0.14 per basic and diluted share, for the 2018
fiscal year.
Research and development expenses for the fiscal
year ended December 31, 2019 were $18,842,752, compared to
$19,919,204 for the 2018 fiscal year. For the fourth quarter of
2019, research and development expenses were $6,308,390, compared
to $8,416,969 for the fourth quarter of 2018. Research and
development expenses for the quarter and year ended December 31,
2019 primarily consisted of expenses for medical and regulatory
affairs and quality assurance programs, as well as expenses from
Catalyst’s ongoing clinical trials and studies evaluating Firdapse
for the treatment of other ultra-orphan neuromuscular diseases and
its Expanded Access Program. Research and development expenses in
the comparable period in 2018, primarily consisted of consulting
expenses and milestones as the Company submitted and the FDA
approved an NDA for Firdapse for the treatment of adults with LEMS,
as well as expenses from Catalyst's 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 2020 as Catalyst completes its on-going
clinical trials and studies in MuSK-MG and SMA Type 3 and continues
its Expanded Access Program and sustained release product
development program for Firdapse.
Selling, general and administrative expenses for
the fiscal year ended December 31, 2019 totaled $36,881,187,
compared to $15,875,961 in the 2018 fiscal year. For the fourth
quarter of 2019, selling, general and administrative expenses
totaled $11,409,213, compared to $6,926,298 in the same period in
2018. The increase year over year 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 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 December 31, 2019, Catalyst had cash and cash
equivalents and investments of $94.5 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 from this date.
More detailed financial information and analysis
may be found in the Company's Annual Report on Form 10-K, which was
filed with the Securities and Exchange Commission (SEC)
on March 16, 2020.
Conference Call
Catalyst management will host an
investment-community conference call and webcast at 8:30 a.m. ET,
tomorrow, Tuesday, March 17, 2020 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 commercial-stage
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) 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. 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 and SMA Type 3 and has
received Orphan Drug Designation from the FDA for
myasthenia gravis.
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 2020 will prove correct, (ii) whether
Catalyst can successfully increase sales of Firdapse from current
levels through expansion of its sales personnel, (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 accepted for filing with Health Canada will be approved;
(vii) whether Catalyst will report results in its current clinical
trials on a timely basis, particularly because of the possible
impact of the recent coronavirus ourtbreak, (viii) whether Firdapse
will ever be approved for the treatment of MuSK-MG, SMA Type 3, or
any other disease, and (ix) the impact on our business generally of
the economic disruptions that may occur because of the recent
coronavirus outbreak, and (x) those other factors described in
Catalyst's Annual Report on Form 10-K for fiscal year 2019 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
MonthsEnded December 31, |
|
For the YearEnded December
31, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Product revenue, net |
$ |
30,122,555 |
|
|
$ |
-- |
|
|
$ |
102,306,337 |
|
|
$ |
-- |
|
Revenues from collaborative
arrangement |
|
-- |
|
|
|
500,000 |
|
|
|
-- |
|
|
|
500,000 |
|
Total revenues |
|
30,122,555 |
|
|
|
500,000 |
|
|
|
102,306,337 |
|
|
|
500,000 |
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
Cost of sales |
|
4,398,265 |
|
|
|
-- |
|
|
|
14,759,139 |
|
|
|
-- |
|
Research and development |
|
6,308,390 |
|
|
|
8,416,969 |
|
|
|
18,842,752 |
|
|
|
19,919,204 |
|
Selling, general and administrative |
|
11,409,213 |
|
|
|
6,926,298 |
|
|
|
36,881,187 |
|
|
|
15,875,961 |
|
Total operating costs and expenses |
|
22,115,868 |
|
|
|
15,343,267 |
|
|
|
70,483,078 |
|
|
|
35,795,165 |
|
Operating income (loss) |
|
8,006,687 |
|
|
|
(14,843,267 |
) |
|
|
31,823,259 |
|
|
|
(35,295,165 |
) |
Other income, net |
|
398,683 |
|
|
|
343,658 |
|
|
|
1,585,774 |
|
|
|
1,291,651 |
|
Net income (loss) before income taxes |
|
8,405,370 |
|
|
|
(14,499,609 |
) |
|
|
33,409,033 |
|
|
|
(34,003,514 |
) |
Provision for income
taxes |
|
475,657 |
|
|
|
-- |
|
|
|
1,533,696 |
|
|
|
-- |
|
Net income (loss) |
$ |
7,929,713 |
|
|
$ |
(14,499,609 |
) |
|
$ |
31,875,337 |
|
|
$ |
(34,003,514 |
) |
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share: |
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.08 |
|
|
$ |
(0.14 |
) |
|
$ |
0.31 |
|
|
$ |
(0.33 |
) |
Diluted |
$ |
0.07 |
|
|
$ |
(0.14 |
) |
|
$ |
0.30 |
|
|
$ |
(0.33 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
|
Basic |
|
103,180,946 |
|
|
|
102,738,170 |
|
|
|
102,944,316 |
|
|
|
102,633,884 |
|
Diluted |
|
106,567,001 |
|
|
|
102,738,170 |
|
|
|
106,020,936 |
|
|
|
102,633,884 |
|
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|
December
31,2019 |
|
December
31,2018 |
|
|
|
|
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
89,511,710 |
|
$ |
16,559,400 |
Short-term investments |
|
5,007,050 |
|
|
36,922,213 |
Accounts receivable, net |
|
10,536,997 |
|
|
-- |
Inventory |
|
1,956,792 |
|
|
56,012 |
Prepaid expenses and other current assets |
|
4,351,074 |
|
|
1,649,781 |
Total current assets |
|
111,363,623 |
|
|
55,187,406 |
Investments |
|
-- |
|
|
5,008,243 |
Operating lease right-of-use asset |
|
793,252 |
|
|
-- |
Property and equipment, net |
|
210,467 |
|
|
245,425 |
Deposits |
|
8,888 |
|
|
8,888 |
Total assets |
$ |
112,376,230 |
|
$ |
60,449,962 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
4,117,447 |
|
$ |
2,337,367 |
Accrued expenses and other liabilities |
|
19,981,295 |
|
|
7,173,987 |
Total current liabilities |
|
24,098,742 |
|
|
9,511,354 |
Accrued expenses and other
liabilities, non-current |
|
-- |
|
|
154,799 |
Operating lease liability, net
of current portion |
|
647,532 |
|
|
-- |
Total liabilities |
|
24,746,274 |
|
|
9,666,153 |
|
|
|
|
Total stockholders’ equity |
|
87,629,956 |
|
|
50,783,809 |
Total liabilities and
stockholders’ equity |
$ |
112,376,230 |
|
$ |
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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