Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and
pharmaceutical company focused on advanced wound care, today
reported financial and operating results for the three and six
months ended June 30, 2011. Highlights of the second quarter of
2011 and recent weeks include:
- Net sales were a record $15.9 million,
up 20% over the prior year second quarter
- Advanced wound care product sales of
$3.8 million increased 47% from the prior year with MEDIHONEY sales
up 66%
- Advanced wound care sales accounted for
24% of net sales, up from 20% from the prior year
- Core product sales for the quarter of
$12.1 million increased 13% over the prior year
- Quarterly net loss decreased to
$551,295 from $976,640 in the prior year
- Reported continued excellent wound
healing at 24 weeks with DSC127 in diabetic foot ulcers
- Preparing for end-of-Phase 2 meeting
with the U.S. Food and Drug Administration (FDA) and began planning
for Phase 3 pivotal trials with DSC127
- Continued licensing dialogues with
potential partners for DSC127
- Raised gross proceeds of $29.1 million,
$26.4 million net, in an equity offering
Management Commentary
“Derma Sciences today is in the strongest position in the
Company’s history, both from a financial and operational
perspective. We achieved record sales in the second quarter due to
an impressive performance by our advanced wound care sales
representatives, who drove both increased sales to existing
accounts as well as to new accounts, and to a solid rebound in our
core products sales, particularly first-aid products,” said Edward
J. Quilty, Derma Sciences chairman and chief executive officer.
“Patients in the follow-up portion of our Phase 2 clinical trial
with DSC127 showed continued healing of diabetic foot ulcers, with
complete healing at 24 weeks following trial enrollment of 73% in
the intent-to-treat population and 85% in the per-protocol
population, a difference of 27 and 33 percentage points,
respectively, compared with patients treated with placebo/standard
of care. We raised $26.4 million and these proceeds, coupled with
the Company's positive cash flow from operations, will allow us to
continue preparations for Phase 3 trials and to immediately expand
our advanced wound care sales force. At this time our funds look to
be sufficient to complete not only the diabetic ulcer Phase 3
trial, but to cover our anticipated expenses through filing of the
NDA.
“The development and marketing of advanced wound care as a
high-margin growth opportunity has been an excellent strategy for
Derma Sciences,” Mr. Quilty continued. “We continue to develop new
line extensions around the MEDIHONEY brand, and recently received
510(k) clearance for MEDIHONEY Hydrogel dressings, which will
expand the use of MEDIHONEY from chronic wounds to include burns
when we launch the product next year. We are optimistic that
MEDIHONEY sales, which increased 66% in the second quarter, will
continue on a strong growth trajectory, and note that for the first
time the prior-year comparison includes a full quarter of sales in
Europe following the licensing of global rights to MEDIHONEY in
February 2010.
“Worldwide advanced wound care sales, which include our
MEDIHONEY franchise as well as our rapidly growing XTRASORB® and
BIOGUARD® lines, among others, increased 47% over the prior year,
and this growth was similar in all territories. We are very pleased
with our ability to replicate the U.S. sales practices to derive
similar results outside the U.S. via our network of direct and
distributed sales. We continue to expect accelerating growth
outside North America as we plan to launch ALGICELL Ag® and our
XTRASORB line of products in the second half of 2011. Our core
wound care business grew 13% during the quarter, largely due to an
increase in first-aid product sales.”
In commenting on the status of DSC127 for the treatment of
diabetic foot ulcers, Mr. Quilty said, “We have been diligently
preparing for a meeting with the FDA, which we anticipate will
occur in the fourth quarter of this year, to discuss the program's
recent positive Phase 2 results and the Company's Phase 3 clinical
trial protocol. Subject to FDA approval, we plan to begin the Phase
3 trial by the end of the first half of 2012. Although we have been
speaking with potential partners about rights to DSC127, our
primary focus has been on our FDA package as we believe that the
value of this asset will be maximized upon approval and initiation
of the Phase 3 program. We believe DSC127 represents an enormous
opportunity for the Company, with a potential annual global market
of $900 million for the rapidly growing population of diabetics
with debilitating and poorly treated foot ulcers,” Mr. Quilty
concluded.
Financial Results
Net sales for the second quarter of 2011 were $15,879,609,
compared with $13,230,106 in the second quarter of 2010, an
increase of 20%. This growth reflects higher sales of both advanced
and core wound care products. Gross profit increased 18% to
$4,626,815, or 29.1% of net sales, compared with $3,913,104, or
29.6% of net sales, in the second quarter of 2010. The slightly
lower gross margin reflects an increase in sales of lower-margin
core products, unfavorable core sales mix towards lower margined
products, and higher cost of goods, partially offset by increasing
sales of higher-margin advanced wound care products.
Selling, general and administrative expenses were $4,945,322,
compared with $4,574,974 in the second quarter of 2010, with the
increase due to investment in sales and marketing associated with
the expansion of the advanced wound care sales force, and marketing
and clinical personnel added in the second half of 2010. The net
loss for the second quarter of 2011 was $551,295, or $0.07 per
share, compared with a net loss of $976,640, or $0.15 per share, in
the prior year’s second quarter.
For the six months ended June 30, 2011, net sales were
$30,250,879, compared with $26,074,487 in the prior year six-month
period, an increase of 16%. The Company reported a net loss of
$1,098,358, or $0.16 per share, in the six months ended June 30,
2011, compared with a net loss of $1,555,329, or $0.25 per share,
in the prior year period.
Working capital as of June 30, 2011 was $37,244,840, compared
with $9,943,929 as of December 31, 2010. This increase reflects
financing activities, positive cash flow from operations, and funds
received from warrant and stock option exercises during the
quarter. As of June 30, 2011 the Company had cash and cash
equivalents of $27,981,224. Subsequent to the close of the quarter,
the Company repaid the $3,340,176 balance on its line of credit.
Management is in the process of evaluating the cost/benefit of
terminating this line of credit. Based on achieving three
consecutive months of MEDIHONEY sales in excess of $600,000
(equivalent to an annual run rate of $7,200,000) the Company
achieved its first MEDIHONEY milestone objective. Accordingly, it
will make a cash payment of $1,000,000 to Comvita New Zealand Ltd.
in August 2011 under the terms of the MEDIHONEY license
agreement.
Conference Call and Webcast
Derma Sciences management will host a conference call to discuss
these results and answer questions today beginning at 11:00 a.m.
Eastern time. In addition, management will provide a business
update and discuss recent and upcoming milestones.
To access the conference call, from the U.S. please dial (888)
563-6275 and from outside the U.S. please dial (706) 634-7417. All
listeners should provide the following passcode: 90475666.
Individuals interested in listening to the live conference call via
the Internet may do so by logging on to the Company’s website,
www.dermasciences.com.
Following the end of the conference call, a telephone replay
will be available through August 22, 2011, and can be accessed by
dialing (855) 859-2056 within the U.S. or (404) 537-3406 outside of
the U.S. All listeners should provide the following passcode:
90475666. The webcast will also be available for 30 days.
About Derma Sciences
Derma Sciences is a medical technology company focused on the
wound care marketplace, addressing; traditional dressings, advanced
wound care dressings, and pharmaceutical wound care products. Its
MEDIHONEY product is the leading brand of honey-based dressings for
the management of wounds and burns. The product has been shown to
be effective in a variety of indications, and was the focus of a
positive large-scale, randomized controlled trial involving 108
subjects with leg ulcers. Other novel products introduced into the
$14 billion global wound care market include XTRASORB for better
management of wound exudate, and BIOGUARD for infection prevention.
Derma Sciences has successfully completed a Phase 2 clinical trial
in diabetic foot ulcer healing with DSC127, a novel pharmaceutical
drug under development for accelerated wound healing and scar
reduction. For more information please visit
www.dermasciences.com.
For more information please visit www.dermasciences.com.
Forward-Looking Statements
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 Commission.
DERMA SCIENCES, INC AND
SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS
(UNAUDITED)
Three Months Ended
June 30,
2011 2010 Net Sales $
15,879,609 $ 13,230,106 Cost of sales 11,252,794
9,317,002
Gross Profit 4,626,815
3,913,104
Operating Expenses Selling,
general and administrative 4,945,322 4,574,974 Research and
development 150,566 123,744 Total operating expenses
5,095,888 4,698,718 Operating loss (469,073)
(785,614) Other expense, net: Interest
expense 121,800 134,707 Other income, net (41,321)
(68,625) Total other expense 80,479 66,082
Loss before income taxes (549,552) (851,696) Income taxes
1,743 124,944
Net Loss $ (551,295)
$ (976,640) Net loss per common share- basic and diluted
$ (0.07) $ (0.15) Shares used in computing net loss
per common share – basic and diluted 7,375,521
6,558,562
Six Months Ended
June 30,
2011 2010 Net Sales $
30,250,879 $ 26,074,487 Cost of sales 21,195,683
18,171,484
Gross Profit 9,055,196
7,903,003
Operating Expenses Selling,
general and administrative 9,683,339 8,762,719 Research and
development 294,394 239,851 Total operating expenses
9,977,733 9,002,570 Operating loss (922,537)
(1,099,567) Other expense, net:
Interest expense 215,429 294,599 Loss on debt extinguishment
- 114,072 Other income, net (114,750)
(178,131) Total other expense 100,679 230,540 Loss
before income taxes (1,023,216) (1,330,107) Income taxes
75,142 225,222
Net Loss $ (1,098,358)
$ (1,555,329) Net loss per common share – basic and diluted
$ (0.16) $ (0.25)
Shares used in computing net loss per
common share – basic and diluted
7,006,902 6,105,386
DERMA SCIENCES, INC. AND
SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
June 30
December 31,
ASSETS
2011
2010
Current Assets Cash and cash equivalents $
27,981,224 $ 404,216 Accounts receivable, net 5,795,587
5,441,511 Inventories 11,515,818 12,498,519 Prepaid
expenses and other current assets 1,509,086 609,164
Total current assets 46,801,715 18,953,410 Equipment and
improvements, net 3,859,796 3,608,242 Identifiable
intangible assets, net 6,124,626 6,971,626 Goodwill
7,119,726 7,119,726 Other assets 266,741
316,859
Total Assets $64,172,604
$36,969,863 LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities
Line of credit borrowings $ 3,340,176 $ 3,075,555
Current maturities of long-term debt - 5,851 Accounts
payable 4,306,405 3,777,454 Accrued expenses and other
current liabilities 1,910,294 2,150,621 Total current
liabilities 9,556,875 9,009,481 Long-term liabilities
305,915 211,581 Deferred tax liability 1,105,135
1,068,088 Total Liabilities 10,967,925
10,289,150 Shareholders’ Equity
Convertible preferred stock, $.01 par
value; 1,468,750 shares authorized; issued and outstanding: 284,635
shares at June 30, 2011 and 284,844 at December 31, 2010
(liquidation preference of $4,191,394 at June 30, 2011)
2,846
2,848
Common stock, $.01 par value; 18,750,000
authorized; issued and outstanding: 10,302,421 at June 30, 2011;
6,563,076 at December 31, 2010
103,024
65,631
Additional paid-in capital 76,228,805 48,803,210
Accumulated other comprehensive income –
cumulative translation adjustments
1,764,278
1,604,940
Accumulated deficit (24,894,274) (23,795,916) Total
Shareholders’ Equity 53,204,679 26,680,713
Total
Liabilities and Shareholders’ Equity $64,172,604
$36,969,863
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