Chelsea Therapeutics Reports Third Quarter 2012 Financial Results

Chelsea Therapeutics Reports Third Quarter 2012 Financial Results

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

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     For the nine months ended
                September 30,                  September 30,
               2012           2011            2012            2011
                                                           
Operating                                                   
expenses:
Research and    $2,479,471   $7,417,477    $15,874,135   $29,557,451
development
Sales and       221,399       2,203,898      6,943,327      4,639,245
marketing
General and     1,169,157     1,278,085      4,530,435      3,928,255
administrative
Restructuring   2,218,347     --            2,218,347      --
Total operating 6,088,374     10,899,460     29,566,244     38,124,951
expenses
                                                           
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       $(0.09)      $(0.18)       $(0.44)       $(0.64)
diluted share
of common stock
                                                           
Weighted
average number
of basic and    67,040,569    61,847,700     66,837,516     59,544,028
diluted common
shares
outstanding
                                                           
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.

CONTACT: Investors:
         Michelle Y. Carroll/Susan Kim
         Argot Partners
         212-600-1902
         michelle@argotpartners.com
         susan@argotpartners.com
        
         Media:
         David Pitts
         Argot Partners
         212-600-1902
         david@argotpartners.com

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