|[January 16, 2014]
Derma Sciences Announces Record Revenues for the 2013 Fourth Quarter and Full Year, Introduces 2014 Revenue Guidance, Provides Update on DSC127 Phase 3 Clinical Trials
PRINCETON, N.J. --(Business Wire)--
Derma Sciences, Inc. (Nasdaq:DSCI), a medical device and pharmaceutical
company focused on advanced wound care, today announced that total
revenue for the full year ended December 31, 2013 is expected to be
$79.7 million, up 7.7% compared with 2012. Advanced wound care (AWC)
revenue for the fourth quarter of 2013 is expected to be $9.4 million,
up 22.5% compared with the fourth quarter of 2012, and full year 2013
AWC revenue is expected to be $33.9 million, up 36.6% compared with
2012. Derma Sciences expects to report 2013 full financial results on
March 14, 2014.
The Company expects 2014 total revenue to increase approximately 15.5%
to $92 million, driven primarily by the continued organic AWC revenue
growth for the year of 30% to 40%.
Barry Wolfenson, the Company's group president of advanced wound care
and pharmaceutical development, said, "Throughout 2013 we continued to
break advanced wound care sales records led by our category-leading
advanced wound care brands MEDIHONEY® and TCC-EZ®. With the addition of
two novel human placental-derived tissue products from BioD to be
branded as AmnioMatrix®, announced earlier this week, along with the
expansion of our advanced wound care sales force, we are looking forward
to continued growth in 2014."
"Today we are introducing 2014 revenue guidance for organic growth in
our advanced wound care business segment to between 30% and 40%, which
is consistent with our historical growth rates," commented Edward J.
Quilty, chairman and chief executive officer of Derma Sciences. "In
addition, we expect our Traditional Wound Care business segment to grow
between 2% and 5% in 2014, driven by stronger sales in Canada, as well
as institutional and retail private label sales growth."
The Company expects to complete patient enrollment in its two Phase 3
pivotal trials with DSC127 for the treatment of diabetic foot ulcers in
the first half of 2015 with top line data read out in the second half of
2015. The Company expects tat costs for the entire development program,
which would include launch inventory, up to the filing of a New Drug
Application (NDA) with the U.S. Food and Drug Administration (FDA), will
be approximately $55 million.
Later this month Derma Sciences will convene a meeting with clinical
investigators in South Africa who will be participating in the trial,
with patient screening initiation at 14 clinical sites expected to occur
Also, Derma Sciences reports that following meetings with its DSC127
development team and several of the leading clinical trial sites
participating in the study, and also upon consultation with several
leading experts in the treatment of diabetic foot ulcers, the Company
has filed amendments with the FDA for various minor changes to the
clinical trial inclusion protocols that Derma Sciences and its advisors
believe will be helpful in accelerating the screening and enrollment of
patients into the Phase 3 clinical trials. In addition, as previously
reported, the Company has added resources in the form of a clinical
trial patient recruitment firm in order to provide further support for
the pace of enrollment. The Company will provide an update at the
halfway point of patient enrollment in the Phase 3 pivotal trials.
In addition to the ongoing development program with DSC127 for the
treatment of diabetic foot ulcers, Derma Sciences announces that it has
initiated preclinical work with this drug candidate for surgical scar
reduction, a second clinical indication.
About Derma Sciences, Inc.
Derma Sciences is a medical technology company focused on three segments
of the wound care marketplace: pharmaceutical wound care products;
advanced wound care dressings to address chronic wounds including
diabetic ulcers; and traditional dressings. The Company has begun its
Phase 3 clinical trials in diabetic foot ulcer healing with DSC127,
based on excellent Phase 2 data. Its MEDIHONEY® product is the leading
brand of honey-based dressings for the management of wounds and burns.
The product has been shown in clinical studies to be effective in a
variety of indications. TCC-EZ® is its gold-standard total contact
casting system for diabetic foot ulcers. Other novel products introduced
into the $14 billion global wound care market include XTRASORB® for
better management of wound exudate, and BIOGUARD® for barrier protection
against microbes and other contaminants.
For more information please visit www.dermasciences.com.
Statements contained in this news release that are not statements of
historical fact may be deemed to be forward-looking statements. Without
limiting the generality of the foregoing, words such as "may," "will,"
"expect," "believe," "anticipate," "intend," "could," "estimate" or
"continue" are intended to identify forward-looking statements. Readers
are cautioned that certain important factors may affect the Company's
actual results and could cause such results to differ materially from
any forward-looking statements that may be made in this news release or
that are otherwise made by or on behalf of the Company. Factors that may
affect the Company's results include, but are not limited to, product
demand, market acceptance, impact of competitive products and prices,
product development, completion of an acquisition, commercialization or
technological difficulties, the success or failure of negotiations and
trade, legal, social and economic risks. Additional factors that could
cause or contribute to differences between the Company's actual results
and forward-looking statements include but are not limited to, those
discussed in the Company's filings with the U.S. Securities and Exchange
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