Chelsea Therapeutics Reports Second Quarter 2013 Financial Results

Chelsea Therapeutics Reports Second Quarter 2013 Financial Results

CHARLOTTE, N.C., Aug. 6, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) today reported financial results for the
second quarter ended June 30, 2013.

"Chelsea continues to diligently manage its financial resources, which are
projected to fund operating expenses into the third quarter of 2014, as we
work to finalize our NDA submission for NORTHERA™ (droxidopa) in the treatment
of symptomatic Neurogenic Orthostatic Hypotension (NOH)," said Joseph G.
Oliveto, Interim CEO of Chelsea. "We anticipate that this effort will be
completed in August, at which point a new PDUFA date, expected in the first
quarter of 2014, will be set by the Agency."

Recent Highlights

  *In early July 2013, Chelsea resubmitted its New Drug Application (NDA) to
    the U.S. Food and Drug Administration (FDA) seeking approval to market
    Northera for the treatment of symptomatic NOH. On July 29, Chelsea
    reported that the U.S. Food and Drug Administration (FDA) identified
    certain technical difficulties with the resubmitted New Drug Application
    (NDA). The Company expects to submit the necessary response in August
    2013, at which point a new six month Prescription Drug User Fee Act
    (PDUFA) review clock is expected to begin.
  *In June 2013, Chelsea was added to the Russell 3000® and Russell 2000®
    Indexes when the Russell Investment Group reconstituted its family of U.S.
    indexes.

Financial Results for the Second Quarter

For the quarter ended June 30, 2013, Chelsea reported a net loss of $3.3
million or ($0.05) per share versus a net loss of $7.9 million or ($0.12) per
share for the same period in 2012. For the first six months of 2013, Chelsea
reported a net loss of $7.3 million or ($0.11) per share compared to a net
loss of $23.4 million or ($0.35) per share for the first half of 2012.

Research and development (R&D) expenses for the quarter ended June 30, 2013
were $1.9 million, compared to $4.7 million for the same period in 2012. For
the six months ended June 30, 2013, research and development expenses were
$3.9 million versus $13.4 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 reflecting
significantly reduced clinical activity in 2013 when compared to 2012.
Droxidopa-related research and development costs during the remainder of 2013
are estimated at approximately $7.9 million and include estimated costs for
the planned new trial of Northera which the Company expects will begin
enrolling patients in the fourth quarter of 2013, costs to prepare for a
potential late-year meeting of CRDAC, and operating costs for research and
development activities including compensation and related costs.

Selling, general and administrative (SG&A) expenses were $1.4 million for the
three months ended June 30, 2013, compared to $3.2 million for the same period
in 2012. For the six months ended June 30, 2013, SG&A expenses were $3.4
million versus $10.1 million for the comparable prior-year period.With no
formalized selling activities or near-term plans for commercialization of any
of our drug candidates, sales and marketing expenses decreased significantly
for the second quarter when compared to the same period of 2012.Costs
incurred in 2013 included compensation and related expenses for our continuing
business development efforts and legal fees related to our intellectual
property activities.

Chelsea ended the quarter with $22.0 million in cash and cash equivalents
compared to $28.4 million as of December 31, 2012. Chelsea anticipates that
its cash and cash equivalents on hand at June 30 should fund the Company's
operations into the third quarter of 2014. This current forecast does not
include significant costs related to commercialization or other activities and
events that are related to and would follow an NDA approval.

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.

Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd.
(DSP), initially received Japanese approval in 1989 for the treatment of
frozen gait and dizziness on standing associated with Parkinson's Disease and
for the treatment of orthostatic hypotension, syncope or dizziness on standing
associated with Shy-Drager syndrome and Familial Amyloid Polyneuropathy. In
2000, Droxidopa received expanded marketing approval to include prevention of
vertigo, dizziness and weakness associated with orthostatic hypotension in
hemodialysis patients.

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; the risk
that FDA will not agree that our clinical trial results demonstrate the safety
and effectiveness of droxidopa; 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 the FDA will not approve the 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 that we
will not be able to obtain 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
(unaudited)
                                                           
                                                           
               For the three months ended June For the six months ended June
                30,                            30,
               2013            2012            2013           2012
                                                           
Operating                                                   
expenses:
Research and    $1,904,849    $4,695,546    $3,861,815   $13,394,664
development
Sales and       241,139        1,753,166      600,423       6,721,928
marketing
General and     1,194,172      1,441,167      2,801,236     3,361,278
administrative
Restructuring   --            --            --           --
Total operating 3,340,160      7,889,879      7,263,474     23,477,870
expenses
                                                           
Operating loss  (3,340,160)    (7,889,879)    (7,263,474)   (23,477,870)
Interest income 4,276          17,594         10,371        46,368
Interest        --            --            --           --
expense
                                                           
Net loss        $(3,335,884)  $(7,872,285)  $(7,253,103) $(23,431,502)
                                                           
Net loss per
basic and       $(0.05)       $(0.12)       $(0.11)      $(0.35)
diluted share
of common stock
                                                           
Weighted
average number
of basic and    67,094,460     67,040,569     67,085,171    66,734,874
diluted common
shares
outstanding


CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
Condensed Consolidated Balance Sheet Data
(unaudited)
                                                          
                                                June 30,   December 31,
                                                2013       2012
                                                (in thousands)
                                                          
Cash and cash equivalents                        $22,012  $28,425
Total assets                                     22,574    28,928
Total liabilities                                2,800     3,011
Deficit accumulated during the development stage (222,315) (215,061)
Stockholders' equity                             19,774    25,916

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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