Chelsea Therapeutics Reports Third Quarter 2012 Financial Results

Increasing Guidance for Year End Cash on Hand to $27 Million

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| Source: Chelsea Therapeutics

CHARLOTTE, N.C., Nov. 7, 2012 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the quarter and nine months ended September 30, 2012.

"As 2012 draws to a close, we look forward to reporting results, in the fourth quarter, from Northera Study 306B, the largest clinical trial ever conducted in symptomatic neurogenic orthostatic hypotension," said Joseph G. Oliveto, Interim CEO of Chelsea. "These data, along with input from the FDA, should enable us to finalize the size and design of an additional confirmatory clinical study to support our effort to gain marketing approval of Northera in Neurogenic OH."

Mr. Oliveto added: "Thanks to our restructuring and ongoing cost containment efforts, we currently project that year-end cash will be over $27 million. Based on our current projections, including the recently announced waiver of a 2013 purchase obligation, this should provide us with sufficient cash runway to cover operations into the second quarter of 2014."

Financial Results for the Third Quarter

For the quarter ended September 30, 2012, Chelsea reported a net loss of $6.1 million or ($0.09) per share versus a net loss of $10.9 million or ($0.18) per share for the same period in 2011.  For the first nine months of 2012, Chelsea reported a net loss of $29.5 million or ($0.44) per share compared to a net loss of $38.0 million or ($0.64) per share for the same period in 2011.

Research and development (R&D) expenses for the third quarter of 2012 were $2.5 million, compared to $7.4 million for the same period in 2011.  For the nine months ended September 30, 2012, research and development expenses were $15.9 million versus $29.6 million for the comparable prior-year period. The reduction in R&D costs is primarily due to the completion of multiple studies in both the droxidopa and antifolate development programs.

Selling, general and administrative (SG&A) expenses were $1.4 million for the three months ended September 30, 2012 compared to $3.5 million for the same period in 2011. For the nine months ended September 30, 2012, SG&A expenses were $11.5 million, compared to $8.6 million for the prior-year period. This increase is primarily due to increased spending during the first quarter of 2012 related to commercialization activity for Northera. During the second and third quarter of 2012, the majority of these activities had been brought to a close as related vendor contracts were cancelled and projects were finalized.

Chelsea ended the quarter with $33.0 million in cash and cash equivalents compared to $45.6 million, including short-term investments, at December 31, 2011. Chelsea anticipates that it will end 2012 with over $27 million in cash and cash equivalents which should fund the company's operations into the second quarter of 2014. While details and timing for a future clinical trial for Northera are yet to be determined, this projection assumes a new trial would commence dosing in the third quarter of 2013 with the initiation of spending expected to begin in the second quarter of 2013.

About Northera

NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure – a group of diseases that includes 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.

         
         
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
         
         
         
  For the three months ended September 30, For the nine months ended September 30,
  2012 2011 2012 2011
         
Operating expenses:        
Research and development  $ 2,479,471  $ 7,417,477  $ 15,874,135  $ 29,557,451
Sales and marketing  221,399  2,203,898  6,943,327  4,639,245
General and administrative  1,169,157  1,278,085  4,530,435  3,928,255
Restructuring  2,218,347  --   2,218,347  -- 
Total operating expenses  6,088,374  10,899,460  29,566,244  38,124,951
         
Operating loss  (6,088,374)  (10,899,460)  (29,566,244)  (38,124,951)
Interest income  12,076  45,222  58,444  131,120
Interest expense  --   --   --   -- 
         
Net loss  $ (6,076,298)  $ (10,854,238)  $ (29,507,800)  $ (37,993,831)
         
         
Net loss per basic and diluted share of common stock  $ (0.09)  $ (0.18)  $ (0.44)  $ (0.64)
         
Weighted average number of basic and diluted common shares outstanding  67,040,569  61,847,700  66,837,516  59,544,028
         
See accompanying notes to condensed consolidated financial statements.
     
     
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
Condensed Consolidated Balance Sheet Data
(unaudited)
     
  September 30, December 31, 
  2012 2011
  (in thousands)
     
Cash and cash equivalents  $ 33,038  $ 41,106
Short-term investments  --   4,500
Total assets  33,807  46,903
Total liabilities  6,113  13,238
Deficit accumulated during the development stage  (212,833)  (183,326)
Stockholders' equity  27,694  33,665
     
     

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 the FDA will not accept any proposal regarding any trial or other data to support Study 301 or any other study, including the primary endpoint; 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 develop 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 risk that we do not achieve anticipated cost savings; reliance on key personnel including specifically in this time of uncertainty following the resignation of Dr. Pedder; risks of distraction of the Board and management at this critical time; 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; and market acceptance for our products if any are approved for marketing.

Investors:
Michelle Y. Carroll/Susan Kim
Argot Partners
212-600-1902



Media:
David Pitts
Argot Partners
212-600-1902