Chelsea Therapeutics Reports Fourth Quarter and Full-Year 2013 Results

Chelsea Therapeutics Reports Fourth Quarter and Full-Year 2013 Results

CHARLOTTE, N.C., March 11, 2014 (GLOBE NEWSWIRE) -- 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   $10,367,757   $16,744,423   $37,270,138   $172,872,603
development
Sales and      1,089,053      7,221,800      8,067,709      25,335,429
marketing
General and    4,977,546      5,679,485      5,276,146      35,880,704
administrative
Restructuring  --            2,157,795      --            2,157,795
Total
operating      16,434,356     31,803,503     50,613,993     236,246,531
expenses
                                                           
Operating loss (16,434,356)   (31,803,503)   (50,613,993)   (236,246,531)
Interest       18,123         67,594         161,828        5,027,236
income
Interest       --            --            --            (258,348)
expense
                                                           
Net loss       $(16,416,233) $(31,735,909) $(50,452,165) $(231,477,643)
                                                           
Net loss per
basic and
diluted share  $(0.24)       $(0.47)       $(0.84)       
ofcommon
stock
                                                           
Weighted
average number
of basic and   68,825,944     66,892,982     60,136,326     
diluted common
shares
outstanding
                                                           
                                                           

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    For the twelve months ended     (inception) to
               December 31,                 December 31,
              2013           2012           2013            2012            December 31,
                                                                             2013
                                                                        
Operating                                                                
expenses:
Research and   $3,946,967   $870,287     $10,367,757   $16,744,423   $172,872,603
development
Sales and      249,547       278,472       1,089,053      7,221,800      25,335,429
marketing
General and    1,128,446     1,149,050     4,977,546      5,679,485      35,880,704
administrative
Restructuring  --           (60,552)      --            2,157,795      2,157,795
Total
operating      5,324,960     2,237,257     16,434,356     31,803,503     236,246,531
expenses
                                                                        
Operating loss (5,324,960)   (2,237,257)   (16,434,356)   (31,803,503)   (236,246,531)
Interest       4,514         9,150         18,123         67,594         5,027,236
income
Interest       --           --           --            --            (258,348)
expense
                                                                        
Net loss       $(5,320,446) $(2,228,107) $(16,416,233) $(31,735,909) $(231,477,643)
                                                                        
Net loss per
basic and
diluted share  $(0.07)      $(0.03)      $(0.24)       $(0.47)       
of common
stock
                                                                        
Weighted
average number
of basic and   73,868,309    67,058,174    68,825,944     66,892,982     
diluted common
shares
outstanding
                                                                        
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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