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 12 months ended December 31, 2010. Highlights of the fourth quarter of 2010 and recent weeks include:
  • Reported positive top-line results from its Phase 2 trial with DSC127 for treating diabetic foot ulcers, including meeting the trial’s primary endpoint of complete healing by 12 weeks and all secondary endpoints measured at the time
  • The last patient completed the durability portion of the Phase 2 study; full 24-week healing and durability data expected to be announced in June
  • Received 510(k) clearance for MEDIHONEY® Gel
  • Advanced wound care product sales for the quarter of $3.6 million increased 59% from the prior year fourth quarter and increased 17% from the third quarter of 2010
  • Core product sales for the quarter of $11.7 million rose 3% from the fourth quarter of 2009
  • Total sales were a record $15.3 million, up 12% over the prior year’s fourth quarter

Management Commentary

“We significantly bolstered our position in the high-margin advanced wound care market segment during the year,” commented Edward J. Quilty, chairman and chief executive officer of the company. “We licensed full global rights to MEDIHONEY and worked to develop and market line extensions such as MEDIHONEY Gel, along with the new products in our XTRASORB® and BIOGUARD® lines. New products and line extensions, aided by the investment of several million dollars during the past year in our 20-person U.S.-based sales force, in addition to the investment in our U.K.-based operations, and in ongoing marketing and clinical support, contributed to a 59% increase in sales of advanced wound care products over the prior year fourth quarter. Sales of advanced wound care products are now 24% of total company sales, up from 17% in the fourth quarter of 2009.”

Mr. Quilty continued, “Our basic wound care business remains solid, with a 3% increase in sales for the quarter over the prior year. However, our gross margin continued to be impacted by record-high cotton prices and other cost of goods, including transportation and obsolescence. We have responded by passing along some of these higher costs to our customers, while remaining price competitive in the market. In addition, sales of our first aid products during the quarter reflect the typical seasonal slowdown during the winter months.”

Commenting on international sales, which began in 2010, Mr. Quilty said, “Our international sales were $546,000 in the fourth quarter, up approximately 61% from the preceding quarter. Sales are increasing due to initial sales into the Middle East and continued growth in key European markets. We have been adding to our distributor coverage with new countries in the EU and the Middle East, and we are making our first inroads into Asia and certain larger South American countries. Our XTRASORB products received CE Marks in February of this year, and we look to have an expanded line of products including XTRASORB and ALGICELL®Ag in the EU in the third quarter of this year.

“Our activities throughout the year and in recent weeks have been transformative for Derma Sciences, highlighted by highly favorable results from the DSC127 Phase 2 trial in diabetic foot ulcer healing. In the intent-to-treat population, by 12 weeks 54% of wounds treated with the 0.03% dose of DSC127 achieved 100% closure, compared with 33% of wounds treated with placebo. In the per-protocol population, results were even more impressive with 65% of wounds treated with the 0.03% dose achieving 100% closure in 12 weeks or less, compared with 38% of wounds treated with placebo.

“The last patients completed a further 12 weeks of follow up just this week, which examines healing rates within the full 24-week time frame along with the durability of the healed wounds. We expect to report the complete 24-week dataset from this trial in June and to submit our report to the U.S. Food and Drug Administration by the end of the third quarter. Developing next steps to advance this drug into a Phase 3 registration trial is a key priority for Derma Sciences. We look forward to multiple value-creating events with DSC127 in the months ahead,” Mr. Quilty concluded.

Financial Results

Net sales for the fourth quarter of 2010 were $15,303,435, compared with $13,648,500 in the fourth quarter of 2009. Gross profit increased 2% to $4,307,124 or 28.1% of sales in the quarter, compared with $4,232,044 or 31.0% of sales in the prior year quarter. Gross profit was adversely impacted by higher product, obsolescence and transportation costs. Total operating expenses were $4,442,478 compared with $4,002,106 in the fourth quarter of 2009 due to increased investment in sales and marketing, partially offset by receipt of a $245,479 research and development grant. The net loss for the fourth quarter of 2010 was $347,198 compared with net income of $843 last year.

Net sales for 2010 were $56,474,056, up 16% compared with net sales for 2009 of $48,526,158. Gross profit was $16,527,332 or 29.3% of sales in 2010, compared with gross profit of $15,057,718 or 31.0% of sales in 2009. The net loss for 2010 was $2,448,864 or $0.39 per share, compared with a net loss for 2009 of $1,282,725 or $0.25 per share.

As of December 31, 2010, working capital was $9,943,929, and cash and cash equivalents were $404,216. Line of credit borrowing was $3,075,555 at year end with approximately $800,000 of additional availability at that time.

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: 54576672. 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 April 6, 2011, and can be accessed by dialing (800) 642-1687 from the U.S. or (706) 645-9291 from outside of the U.S. All listeners should provide the following passcode: 54576672. The webcast will be available for 30 days.

About Derma Sciences

Derma Sciences is a medical technology company focused on three segments of the wound care marketplace: pharmaceutical wound care products, advanced wound care dressings and traditional dressings. Derma Sciences has successfully completed the treatment phase of 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. 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.

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
 
Three Months Ended

December 31, (unaudited)
        2010       2009
Net Sales $ 15,303,435         $ 13,648,500  
Cost of sales         10,996,311           9,416,456  
Gross Profit         4,307,124           4,232,044  
Operating Expenses                  
Selling, general and administrative   4,565,050           3,890,886  
Research and development         (122,572 )         111,220  
Total operating expenses         4,442,478           4,002,106  
Operating (loss) income         (135,354 )         229,938  
Other expense, net:                  
Interest expense   166,502           210,224  
Other income, net         (86,555 )         (131,805 )
Total other expense, net         79,947           78,419  
(Loss) income before income taxes   (215,301 )         151,519  
Income taxes         131,897           150,676  
Net (Loss) Income       $ (347,198 )       $ 843  
Net (Loss) Income per common share- basic       $ (0.05 )       $ 0.00  
Net (Loss) Income per common share- diluted       $ (0.05 )       $ 0.00  
Shares used in computing Net (Loss) income per common share–basic         6,562,682           5,029,372  
Shares used in computing Net (Loss) income per common share–diluted         6,562,682           5,474,975  
     
Year Ended

December 31,
        2010       2009
Net Sales $ 56,474,056         $ 48,526,158  
Cost of sales         39,946,724           33,468,440  
Gross Profit         16,527,332           15,057,718  
Operating Expenses                  
Selling, general and administrative   17,905,097           15,135,233  
Research and development         292,660           399,558  
Total operating expenses         18,197,757           15,534,791  
Operating loss         (1,670,425 )         (477,073 )
Other expense, net:                  
Interest expense   580,622           842,132  
Loss on debt extinguishment   114,072           -  
Other income, net         (340,216 )         (244,596 )
Total other expense, net         354,478           597,536  
Loss before income taxes   (2,024,903 )         (1,074,609 )
Income taxes         423,961           208,116  
Net Loss       $ (2,448,864 )       $ (1,282,725 )
Net Loss per common share – basic and diluted       $ (0.39 )       $ (0.25 )
Shares used in computing Net Loss per common share–basic and diluted         6,335,798           5,031,557  
           

DERMA SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS
 

 

ASSETS
     

December 31,2010
     

December 31,

2009
Current Assets            
Cash and cash equivalents $ 404,216   $ 243,524  
Accounts receivable, net   5,441,511     3,372,712  
Inventories   12,498,519     11,489,724  
Prepaid expenses and other current assets         609,164           456,675  
Total current assets   18,953,410     15,562,635  
Cash – restricted   -     2,032,164  
Equipment and improvements, net   3,608,242     3,741,347  
Identifiable intangible assets, net   6,971,626     3,994,250  
Goodwill   7,119,726     7,119,726  
Other assets         316,859           849,753  
Total Assets       $ 36,969,863         $ 33,299,875  
LIABILITIES AND SHAREHOLDERS’ EQUITY                        
Current Liabilities                  
Line of credit borrowings $ 3,075,555         $ 2,306,306  
Current maturities of long-term debt   5,851           1,759,185  
Accounts payable   3,777,454           3,363,096  
Accrued expenses and other current liabilities         2,150,621           1,342,467  
Total current liabilities   9,009,481           8,771,054  
Long-term debt   -           2,305,851  
Other long-term liabilities   211,581           96,564  
Deferred tax liability         1,068,088           895,306  
Total Liabilities         10,289,150           12,068,775  
                 
Commitments                  
                 
Shareholders’ Equity                  
Convertible preferred stock, $.01 par value; 1,468,750 shares
authorized; issued and outstanding 284,844 at December 31, 2010
and 285,051 at December 31,2009 (liquidation preference of
$4,201,426 at December 31, 2010)   2,848           2,851  
Common stock, $.01 par value; 18,750,000 authorized; issued and
outstanding 6,563,076 at December 31, 2010 and 5,039,468 at
December 31, 2009   65,631           50,395  
Additional paid-in capital   48,803,210           41,221,613  
Accumulated other comprehensive income –
cumulative translation adjustments   1,604,940           1,303,293  
Accumulated deficit         (23,795,916 )         (21,347,052 )
Total Shareholders’ Equity         26,680,713           21,231,100  
Total Liabilities and Shareholders’ Equity       $ 36,969,863         $ 33,299,875  

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