Chelsea Therapeutics Reports Fourth Quarter and Full-Year 2013 Results
March 11 2014 - 4:25PM
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today
reported financial results for the fourth quarter and full year
ended December 31, 2013.
"FDA approval of NORTHERA™ (droxidopa) this February for
symptomatic neurogenic orthostatic hypotension is Chelsea
Therapeutics' most important milestone to date," said Joseph G.
Oliveto, President and CEO of Chelsea. "NORTHERA is the first new
treatment option approved for this indication in nearly two
decades, representing a significant market opportunity. We continue
to pursue a dual path of actively assessing the Company's strategic
alternatives and preparing for the commercial launch of
NORTHERA."
Financial Results for the Fourth Quarter
For the quarter ended December 31, 2013, Chelsea reported a net
loss of $5.3 million or ($0.07) per share versus a net loss of $2.2
million or ($0.03) per share for the same period in 2012. For the
twelve months ended December 31, 2013, Chelsea reported a net loss
of $16.4 million or ($0.24) per share compared to a net loss of
$31.7 million of ($0.47) per share for the same period in 2012.
Research and development (R&D) expenses for the fourth
quarter of 2013 were $3.9 million, compared to $0.9 million for the
same period in 2012. For the twelve months ended December 31, 2013,
research and development expenses were $10.4 million, versus $16.7
million for 2012. The reduction in R&D costs year over year is
primarily due to the completion of multiple studies in both the
droxidopa and antifolate development programs during 2012,
contributing to significantly reduced R&D spending during the
first three quarters of 2013.
Selling, general and administrative (SG&A) expenses were
$1.4 million for the three months ended December 31, 2013, compared
to $1.4 million for the same period in 2012. For the twelve months
ended December 31, 2013, SG&A expenses were $6.1 million,
compared to $12.9 million for the prior-year period. The reduction
in SG&A expenses were primarily due to decreases in
compensation and related costs associated with the reduction in
force that occurred in July 2012. Costs incurred in 2013 included
compensation and related expenses for continuing administrative and
business development efforts, legal fees and other professional
fees.
Chelsea ended the year with $45.3 million in cash and cash
equivalents compared to $28.4 million, as of December 31, 2012.
Plans for a NORTHERA™ launch are progressing while the Company
continues to evaluate other strategic alternatives.
About NORTHERA
NORTHERA is indicated for the treatment of orthostatic
dizziness, lightheadedness, or the "feeling that you are about to
black out" in adult patients with symptomatic NOH caused by primary
autonomic failure (Parkinson's disease, multiple system atrophy and
pure autonomic failure), dopamine beta hydroxylase deficiency and
non-diabetic autonomic neuropathy.
Droxidopa was initially developed by Dainippon Sumitomo Pharma
Co., Ltd. (DSP) and first commercialized in Japan in 1989.
Please see NORTHERA full Prescribing Information including Most
Serious Side Effects for additional Important Safety Information at
http://www.chelseatherapeutics.com.
For product information, or to report SUSPECTED ADVERSE
REACTIONS, contact Chelsea Therapeutics, Inc. at 1-855-351-2879 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Chelsea Therapeutics
Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical
development company that acquires, develops and commercializes
innovative products for the treatment of a variety of human
diseases, including central nervous system disorders. Chelsea
acquired global development and commercialization rights to
droxidopa (L-DOPS), or NORTHERA, from Dainippon Sumitomo Pharma
Co., Ltd. in 2006, excluding Japan, Korea, China and Taiwan. For
more information about the Company, visit
www.chelseatherapeutics.com.
This press release contains forward-looking statements regarding
future events including our intention to pursue the development of
NORTHERA . These statements are subject to risks and uncertainties
that could cause the actual events or results to differ materially.
These include the risk that we are unable to successfully
commercialize NORTHERA; the risks associated with fulfilling sales,
marketing and distribution requirements; reliance on key personnel
and our ability to attract and/or retain key personnel; the risk
that FDA will not agree that our clinical trial results demonstrate
the safety and effectiveness of droxidopa or fulfill the post
marketing requirements to achieve full approval; the risk that our
resources will not be sufficient to conduct any study of NORTHERA
that will be acceptable to the FDA; the risk that we cannot
complete Study 401 or any other additional study for NORTHERA
without the need for additional capital; the risks and costs of
drug development and that such development may take longer or be
more expensive than anticipated; our need to raise additional
operating capital in the future; our reliance on our lead drug
candidate droxidopa; the risk that we will not be able to obtain
regulatory approvals of droxidopa or our other drug candidates for
additional indications; the risk of volatility in our stock price,
related litigation, and analyst coverage of our stock; reliance on
collaborations and licenses; intellectual property risks; our
history of losses; competition; market acceptance for our products
when approved for marketing.
CHELSEA THERAPEUTICS
INTERNATIONAL, LTD. AND SUBSIDIARY |
(A Development Stage
Company) |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
April 3, 2002 |
|
For
the years ended December 31, |
(inception) through |
|
2013 |
2012 |
2011 |
December 31,
2013 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
$ 10,367,757 |
$ 16,744,423 |
$ 37,270,138 |
$ 172,872,603 |
Sales and marketing |
1,089,053 |
7,221,800 |
8,067,709 |
25,335,429 |
General and administrative |
4,977,546 |
5,679,485 |
5,276,146 |
35,880,704 |
Restructuring |
-- |
2,157,795 |
-- |
2,157,795 |
Total operating expenses |
16,434,356 |
31,803,503 |
50,613,993 |
236,246,531 |
|
|
|
|
|
Operating loss |
(16,434,356) |
(31,803,503) |
(50,613,993) |
(236,246,531) |
Interest income |
18,123 |
67,594 |
161,828 |
5,027,236 |
Interest expense |
-- |
-- |
-- |
(258,348) |
|
|
|
|
|
Net loss |
$ (16,416,233) |
$ (31,735,909) |
$ (50,452,165) |
$ (231,477,643) |
|
|
|
|
|
Net loss per basic and diluted share
of common stock |
$ (0.24) |
$ (0.47) |
$ (0.84) |
|
|
|
|
|
|
Weighted average number of basic and diluted
common shares outstanding |
68,825,944 |
66,892,982 |
60,136,326 |
|
|
|
|
|
|
|
|
|
|
|
CHELSEA THERAPEUTICS
INTERNATIONAL, LTD. AND SUBSIDIARY |
(A Development Stage
Company) |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
April 3, 2002 |
|
For
the three months ended December 31, |
For
the twelve months ended December 31, |
(inception) to |
|
2013 |
2012 |
2013 |
2012 |
December 31,
2013 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ 3,946,967 |
$ 870,287 |
$ 10,367,757 |
$ 16,744,423 |
$ 172,872,603 |
Sales and marketing |
249,547 |
278,472 |
1,089,053 |
7,221,800 |
25,335,429 |
General and administrative |
1,128,446 |
1,149,050 |
4,977,546 |
5,679,485 |
35,880,704 |
Restructuring |
-- |
(60,552) |
-- |
2,157,795 |
2,157,795 |
Total operating expenses |
5,324,960 |
2,237,257 |
16,434,356 |
31,803,503 |
236,246,531 |
|
|
|
|
|
|
Operating loss |
(5,324,960) |
(2,237,257) |
(16,434,356) |
(31,803,503) |
(236,246,531) |
Interest income |
4,514 |
9,150 |
18,123 |
67,594 |
5,027,236 |
Interest expense |
-- |
-- |
-- |
-- |
(258,348) |
|
|
|
|
|
|
Net loss |
$ (5,320,446) |
$ (2,228,107) |
$ (16,416,233) |
$ (31,735,909) |
$ (231,477,643) |
|
|
|
|
|
|
Net loss per basic and diluted share of
common stock |
$ (0.07) |
$ (0.03) |
$ (0.24) |
$ (0.47) |
|
|
|
|
|
|
|
Weighted average number of basic and diluted
common shares outstanding |
73,868,309 |
67,058,174 |
68,825,944 |
66,892,982 |
|
|
|
|
|
|
|
See accompanying notes to
condensed consolidated financial statements. |
|
|
|
|
|
|
|
|
|
|
|
|
CHELSEA THERAPEUTICS
INTERNATIONAL, LTD. AND SUBSIDIARY |
Condensed Consolidated Balance
Sheet Data |
(unaudited) |
|
|
|
|
December 31, |
December 31, |
|
2013 |
2012 |
|
(in
thousands) |
|
|
|
Cash and cash equivalents |
$ 45,323 |
$ 28,425 |
Total assets |
46,503 |
28,928 |
Total liabilities |
3,247 |
3,011 |
Deficit accumulated during the development
stage |
(231,478) |
(215,061) |
Stockholders' equity |
43,256 |
25,916 |
CONTACT: Media:
David Connolly
LaVoie Group
617-374-8800, Ext. 104
dconnolly@lavoiegroup.com
Investors:
Susan Kim
Argot Partners
212-600-1902
susan@argotpartners.com
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