Discovery Laboratories, Inc.
) reported fourth quarter 2013 loss (excluding change in fair
value of common stock warrant liability) of 15 cents per share,
narrower than the Zacks Estimate of a loss of 16 cents per share.
The loss (excluding change in fair value of common stock warrant
liability) in the year-ago quarter was approximately 29 cents.
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The company reported revenues of $74,000 in the final quarter of
2013, down 62%. Discovery Labs stated that revenues worth
$140,000 from its approved drug Surfaxin were deferred in
accordance with the revenue recognition policy followed by the
company. Surfaxin, an intratracheal suspension, has been cleared
by the U.S. Food and Drug Administration (FDA) for the prevention
of respiratory distress syndrome (RDS) in premature infants who
are at high risk of being affected by the disease.
Surfaxin is the first FDA-approved synthetic, peptide-containing
surfactant available for the prevention of RDS in premature
infants. Before Surfaxin, only animal-derived surfactants like
) Survanta were available in the market.
Discovery Labs reported research & development (R&D)
costs of $5.8 million in the final quarter of 2013 as against
$6.1 million in the year-ago quarter. Selling, general &
administrative (SG&A) costs declined 37% to $4.1 million in
the final quarter of 2013.
For full year 2013, revenues jumped 99% to $388,000. The Zacks
Consensus Estimate was $1 million. Loss for 2013 (excluding
change in fair value of common stock warrant liability) narrowed
to 83 cents per share from 96 cents incurred in 2012. The Zacks
Consensus Estimate hinted at a loss of 84 cents per share.
Apart from releasing financial results, Discovery Labs provided
an update on RDS candidate, Aerosurf. The company is evaluating
the candidate in a phase IIa open label, single-dose study.
Discovery Labs expects to report results from the study in the
third quarter of this year.
Shares Down on Withdrawal of Surfaxin 2014 Sales
Shares of Discovery Labs tumbled in excess of 11% primarily due
to the company's decision to withdraw the previously announced
guidance of $8 million-$10 million for Surfaxin sales. The
company said that it is of the opinion that the time needed to
have the drug reviewed by hospital committees, accepted on
hospital formulary, purchased by the hospital pharmacy and used
in the neonatal intensive care unit is longer than what it had
assumed while issuing the previous short-term revenue guidance
for the drug. The company believes that it needs more actual
experience pertaining to Surfaxin product cycle time to
effectively project short-term sales of the drug,.
Discovery Labs carries a Zacks Rank #3 (Hold). Some better-ranked
stocks in the sector include
Alexion Pharmaceuticals, Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).