Chelsea Therapeutics Reports First Quarter 2013 Financial Results

Chelsea Therapeutics Reports First Quarter 2013 Financial Results

CHARLOTTE, N.C., May 1, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) today reported financial results for the
first quarter ended March 31, 2013.

"In the first quarter, we made significant progress toward the
commercialization of Northera™ (droxidopa) for the treatment of symptomatic
Neurogenic Orthostatic Hypotension, a debilitating orphan condition that is
greatly in need of alternative therapies," said Joseph G. Oliveto, Interim CEO
of Chelsea. "Our team has navigated through the significant challenges of
showing a symptomatic benefit in this difficult to treat disease state, and
now, with updated guidance from the U.S. Food and Drug Administration, we have
a regulatory path forward toward review and potential approval this year. We
remain focused on resubmission of a New Drug Application for Northera in NOH."

First Quarter Highlights

  *In February 2013, Chelsea received written guidance from the Director of
    the Office of New Drugs at the U.S. FDA stating that Study 306B has the
    potential to serve as the basis for a resubmission of a Northera NDA for
    the treatment of symptomatic NOH. The Company intends to resubmit the
    Northera NDA in the second quarter or the early weeks of the third quarter
    of 2013. Chelsea also intends to initiate a new clinical trial in the
    fourth quarter of 2013, given FDA guidance regarding the potential need
    for Chelsea to verify the durability of effect of Northera in a
    post-marketing study.
  *In March 2013, the results from Studies 306A and 306B were presented at
    the American Academy of Neurology's 65th Annual Meeting, where they were
    featured as part of the 2013 Emerging Science Program and highlighted by
    the AAN both in a data blitz and press release titled "New Drugs May
    Improve Quality of Life for People with Parkinson's Disease".

Financial Results for the First Quarter

For the quarter ended March 31, 2013, Chelsea reported a net loss of $3.9
million or ($0.06) per share versus a net loss of $15.6 million or ($0.23) per
share for the same period in 2012.

Research and development (R&D) expenses for the quarter ended March 31, 2013
were $2.0 million, compared to $8.7 million for the same period in 2012. The
reduction in R&D costs is primarily due to the completion of multiple studies
in both the droxidopa and antifolate development programs in
2012.Droxidopa-related research and development costs during the remainder of
2013 are estimated at $11.3 million and include final costs for our access and
safety program for Neurogenic OH patients, estimated costs for our planned new
trial of Northera scheduled to begin patient dosing in the fourth quarter of
2013, our planned 300mg bioequivalence study and costs to prepare and submit
our revised Northera NDA.

Selling, general and administrative (SG&A) expenses were $2.0 million for the
three months ended March 31, 2013, compared to $6.9 million for the same
period in 2012. The period to period changes in SG&A costs are primarily
related to our significant spending on Northera commercialization and launch
preparation activities that occurred during the latter half of 2011 and the
first half of 2012.By the end of the second quarter of 2012, the majority of
these activities had been brought to a close as related vendor contracts were
cancelled and projects were finalized subsequent to receipt of the Complete
Response Letter from the FDA in March 2012.

Chelsea ended the quarter with $25.1 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 March 31 should fund the Company's
operations into the third quarter of 2014. While details for a future
clinical trial for Northera are yet to be determined, this projection assumes
a new trial would commence dosing in the fourth quarter of 2013.In addition
to the initial costs of a new trial, assumptions underlying this guidance
cover costs related to the NDA re-submission.This current forecast does not
include material activities related to an NDA approval or the
commercialization of Northera.

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

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.

(A Development Stage Company)
                                                           Period from
                                                           April 3, 2002
                            For the three months ended March (inception) to
                            2013            2012             March 31, 2013
Operating expenses:                                         
Research and development     $1,956,966    $8,699,119     $164,461,812
Sales and marketing          359,284        4,968,762       24,605,660
General and administrative   1,607,064      1,920,111       32,510,222
Restructuring                --            --             2,157,795
Total operating expenses     3,923,314      15,587,992      223,735,489
Operating loss               (3,923,314)    (15,587,992)    (223,735,489)
Interest income              6,095          28,774          5,015,208
Interest expense             --            --             (258,348)
Net loss                     $ (3,917,219)  $ (15,559,218)  $(218,978,629)
Net loss per basic and
diluted share of common      $(0.06)       $(0.23)        
Weighted average number of
basic and diluted common     67,075,779     66,429,178      
shares outstanding
See accompanying notes to condensed consolidated financial statements.

Condensed Consolidated Balance Sheet Data
                                                March 31,  December 31,
                                                2013       2012
                                                (in thousands)
Cash and cash equivalents                        $25,059  $28,425
Total assets                                     25,720    28,928
Total liabilities                                3,095     3,011
Deficit accumulated during the development stage (218,979) (215,061)
Stockholders' equity                             22,625    25,916

CONTACT: Investors:
         Fara Berkowitz / Susan Kim
         Argot Partners
         David Pitts
         Argot Partners

Chelsea Therapeutics Logo
Press spacebar to pause and continue. Press esc to stop.