Chelsea Therapeutics International Ltd.
) reported fourth quarter 2013 loss of 7 cents per share, in line
with the Zacks Consensus Estimate, but wider than the year-ago
loss of 3 cents per share.
In 2013, Chelsea Therapeutics reported a loss of 24 cents per
share, narrower than the year-ago loss of 44 cents per share but
a penny wider than the Zacks Consensus Estimate of a loss of 23
cents per share.
In 2013, Chelsea Therapeutics did not have any approved
product in its portfolio and hence did not generate any revenues
in the reported quarter as well as in 2013. The company's first
drug to gain U.S. Food and Drug Administration (FDA) approval is
Northera, which was approved in Feb 2014.
In the fourth quarter of 2013, Chelsea Therapeutics' R&D
expenses shot up by 353.5% year over year to $3.9 million.
General and administrative (G&A) expenses edged down 1.8%
year over year to $1.1 million.
Northera, is currently the only therapy approved by the FDA
for the treatment of orthostatic dizziness, lightheadedness, or
the "feeling that you are about to black out" in adults with
symptomatic neurogenic orthostatic hypotension (NOH) caused by
primary autonomic failure, DBH deficiency, and non-diabetic
autonomic neuropathy. Chelsea Therapeutics intends to begin
commercialization of Northera in the second half of 2014.
We note that Northera has orphan drug designation in the U.S.
and the EU with seven years and ten years of marketing
Meanwhile, Chelsea Therapeutics plans to pursue label
expansion of Northera. The company said that it intends to study
Northera for other norepinephrine-related conditions and
We are positive on the FDA approval for Northera. Chelsea
Therapeutics currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks in the biotech sector include
Alexion Pharmaceuticals, Inc.
Gilead Sciences Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).
ALEXION PHARMA (ALXN): Free Stock Analysis
AMGEN INC (AMGN): Free Stock Analysis Report
CHELSEA THERAP (CHTP): Free Stock Analysis
GILEAD SCIENCES (GILD): Free Stock Analysis
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