Chelsea Therapeutics Reports Third Quarter 2013 Financial Results
CHARLOTTE, N.C., Nov. 5, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) today reported financial results for the
third quarter ended September 30, 2013.
"The third quarter of 2013 was marked by the successful resubmission of our
New Drug Application for NORTHERA™ and its acceptance by the U.S. Food and
Drug Administration (FDA)," said Joseph G. Oliveto, Interim CEO of Chelsea.
"We are actively preparing for our Advisory Committee Meeting in mid-January
2014, followed by our expected PDUFA goal date in mid-February 2014. Chelsea
continues to diligently manage its financial resources, which are now
projected to fund operating expenses into the first quarter of 2015."
Third Quarter 2013 and Recent Highlights
*In October 2013, Chelsea announced that the FDA had notified the Company
that its NDA seeking approval to market NORTHERA™ (droxidopa) will be
reviewed by the Cardiovascular and Renal Drug Advisory Committee (CRDAC).
The meeting is tentatively scheduled for January 14, 2014.
*In September 2013, Chelsea announced that the FDA acknowledged receipt of
its New Drug Application (NDA) resubmission seeking approval to market
Northera for the treatment of symptomatic NOH. The FDA deemed the
resubmission a complete response to its March 28, 2012 Complete Response
Letter and assigned a new Prescription Drug User Fee Act (PDUFA) goal date
of February 14, 2014.
Financial Results for the Third Quarter
For the quarter ended September 30, 2013, Chelsea reported a net loss of $3.8
million or ($0.06) per share versus a net loss of $6.1 million or ($0.09) per
share for the same period in 2012. For the first nine months of 2013, Chelsea
reported a net loss of $11.1 million or ($0.17) per share compared to a net
loss of $29.5 million or ($0.44) per share for the first nine months of 2012.
Research and development (R&D) expenses for the quarter ended September 30,
2013 were $2.6 million, compared to $2.5 million for the same period in 2012.
The increase was primarily due to initial costs related to the start-up for
Study 401, the NORTHERA™ NDA and Advisory Committee meeting preparation
activities. For the nine months ended September 30, 2013, research and
development expenses were $6.4 million versus $15.9 million for the comparable
prior-year period. The reduction in R&D costs for the nine months period 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
$4.2 million and include estimated costs for Study 401, the planned new trial
of NORTHERA™, which the Company expects will begin enrolling patients in the
fourth quarter of 2013, costs to prepare for the January 2014 meeting of the
CRDAC, and operating costs for research and development activities including
compensation and related costs.
Selling, general and administrative (SG&A) expenses were $1.3 million for the
three months ended September 30, 2013, compared to $1.4 million for the same
period in 2012. For the nine months ended September 30, 2013, SG&A expenses
were $4.7 million versus $11.5 million for the comparable prior-year
period.The reduction is SG&A expenses were primarily due to decreases in
compensation and related costs associated with the reduction in force that
occurred in July 2012.Costs incurred in 2013 included compensation and
related expenses for our continuing administrative and business development
efforts, legal fees and other professional fees.
Chelsea ended the quarter with $20.9 million in cash and cash equivalents
compared to $28.4 million as of December 31, 2012. This includes
approximately $2.8 million of net proceeds, after expenses, raised through the
As of November 1, 2013 the Company had raised total net proceeds, after
expenses, of $10.4 million under its ATM.On November 1, 2013, Chelsea elected
to terminate the ATM sales agreement and, pursuant to that agreement, notified
the bank of our intent to terminate effective November 11, 2013.No further
sales will be made under the ATM.Chelsea anticipates that its cash and cash
equivalents on hand at September 30, along with the proceeds raised from its
ATM as more fully described above, should fund the Company's operations into
the first quarter of 2015. 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 from the FDA.
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 Amyloidotic Polyneuropathy.
In 2000, Droxidopa received expanded marketing approval to include prevention
of vertigo, dizziness and weakness associated with orthostatic hypotension in
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; the risk
that the 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; and 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
For the three months ended For the nine months ended
September 30, September 30,
2013 2012 2013 2012
Research and $2,558,975 $2,479,471 $6,420,790 $15,874,135
Sales and 239,083 221,399 839,506 6,943,327
General and 1,047,864 1,169,157 3,849,100 4,530,435
Restructuring -- 2,218,347 -- 2,218,347
Total operating 3,845,922 6,088,374 11,109,396 29,566,244
Operating loss (3,845,922) (6,088,374) (11,109,396) (29,566,244)
Interest income 3,239 12,076 13,610 58,444
Interest expense -- -- -- --
Net loss $(3,842,683) $(6,076,298) $(11,095,786) $(29,507,800)
Net loss per
basic and $(0.06) $(0.09) $(0.17) $(0.44)
of common stock
number of basic
and diluted 67,208,361 67,040,569 67,126,686 66,837,516
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
Condensed Consolidated Balance Sheet Data
September 30, December 31,
Cash and cash equivalents $20,882 $28,425
Total assets 22,145 28,928
Total liabilities 2,954 3,011
Deficit accumulated during the development stage (226,157) (215,061)
Stockholders' equity 19,191 25,916
Fara Berkowitz / Susan Kim
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