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Chelsea Therapeutics Reports Fourth Quarter And Full-Year 2012 Results

Stocks in this article: CHTP

About Northera

NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure – an indication that includes a significant number of patients with Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF).  Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally.

About Chelsea Therapeutics

Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders.  Chelsea is currently pursuing FDA approval in the U.S. for Northera™ (droxidopa), a novel, late-stage, orally-active therapeutic agent for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure.  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 reliance on key personnel and our ability to attract and/or retain key personnel, risks of distraction of the Board and management at this critical time; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that we will not be able to resubmit the NDA for Northera and that the FDA will not approve a resubmitted NDA; 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 any 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; risk of regulatory approvals of droxidopa or our other drug candidates for additional indications; 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 if any are 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
  2012 2011 2010 December 31, 2012
       
Operating expenses:        
Research and development  $ 16,744,423  $ 37,270,138  $ 30,871,125  $ 162,504,846
Sales and marketing  7,221,800  8,067,709  2,476,494  24,246,376
General and administrative  5,679,485  5,276,146  4,154,944  30,903,158
Restructuring  2,157,795  --   --   2,157,795
Total operating expenses  31,803,503  50,613,993  37,502,563  219,812,175
         
Operating loss  (31,803,503)  (50,613,993)  (37,502,563)  (219,812,175)
Interest income  67,594  161,828  242,883  5,009,113
Interest expense  --   --   (70,389)  (258,348)
         
Net loss  $ (31,735,909)  $ (50,452,165)  $ (37,330,069)  $ (215,061,410)
         
Net loss per basic and diluted share of common stock  $ (0.47)  $ (0.84)  $ (0.91)  
         
Weighted average number of basic and diluted common shares outstanding  66,892,982  60,136,326  41,184,623  
 
 
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
         
        Period from
  For the three months ended    For the twelve months ended April 3, 2002
  December 31,  December 31,  (inception) to
  2012 2011 2012 2011 December 31, 2012
           
Operating expenses:          
Research and development  $ 870,287  $ 7,712,687  $ 16,744,423  $ 37,270,138  $ 162,504,846
Sales and marketing  278,472  3,428,463  7,221,800  8,067,709  24,246,376
General and administrative  1,149,050  1,347,891  5,679,485  5,276,146  30,903,158
Restructuring  (60,552)  --   2,157,795  --   2,157,795
Total operating expenses  2,237,257  12,489,041  31,803,503  50,613,993  219,812,175
           
Operating loss  (2,237,257)  (12,489,041)  (31,803,503)  (50,613,993)  (219,812,175)
Interest income  9,150  30,708  67,594  161,828  5,009,113
Interest expense  --   --   --   --   (258,348)
           
Net loss  $ (2,228,107)  $ (12,458,333)  $ (31,735,909)  $ (50,452,165)  $ (215,061,410)
           
Net loss per basic and diluted share of common stock  $ (0.03)  $ (0.20)  $ (0.47)  $ (0.84)  
           
Weighted average number of basic and diluted common shares outstanding  67,058,174  61,893,905  66,892,982  60,136,326  
   
See accompanying notes to condensed consolidated financial statements.  
 
 
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
Condensed Consolidated Balance Sheet Data
(unaudited)
     
  December 31, December 31, 
  2012 2011
  (in thousands)
     
Cash and cash equivalents  $ 28,425  $ 41,106
Short-term investments  --   4,500
Total assets  28,928  46,903
Total liabilities  3,011  13,238
Deficit accumulated during the development stage  (215,061)  (183,326)
Stockholders' equity  25,916  33,665
CONTACT: Investors:
         Fara Berkowitz / Susan Kim
         Argot Partners
         212-600-1902
         fara@argotpartners.com
         susan@argotpartners.com
         
         Media:
         David Pitts
         Argot Partners
         212-600-1902
         david@argotpartners.com

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