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8-K - FORM 8-K - ORASURE TECHNOLOGIES INCd8k.htm

Exhibit 99

LOGO

Company Contact:

 

Ronald H. Spair
Chief Financial Officer
610-882-1820

Investorinfo@orasure.com

www.orasure.com

OraSure Announces Fourth Quarter and Full Year 2010 Financial Results

BETHLEHEM, PA – February 9, 2011 – (GlobeNewswire) – OraSure Technologies, Inc. (NASDAQ: OSUR), a market leader in oral fluid diagnostics, today announced revenues of $75.0 million and $18.8 million for the year and quarter ended December 31, 2010, respectively. This compares to revenues of $77.0 million and $20.9 million for the year and quarter ended December 31, 2009.

The Company recorded a net loss of $3.5 million, or $0.08 per share, and $1.0 million, or $0.02 per share, for the year and quarter ended December 31, 2010, respectively. This compares to a net loss of $7.8 million, or $0.17 per share, and $2.8 million, or $0.06 per share, for the year and quarter ended December 31, 2009, respectively. Fourth quarter and full year 2009 results include $1.5 million in pre-tax litigation settlement expense. Also included in the full year 2009 results is a $3.0 million pre-tax impairment charge related to the net book value of payments previously capitalized under an HCV patent license agreement.

“We exceeded our fourth quarter guidance on both the top and bottom lines and are pleased to have ended 2010 on a strong note,” said Douglas A. Michels, President and CEO of OraSure Technologies. “During this past year, we also made good progress advancing our clinical programs, most notably with the receipt of a venous whole blood approval and the FDA submission for a finger stick whole blood claim for our OraQuick® HCV test. We also initiated the final clinical study phase for our at-home HIV test and expanded our infectious disease portfolio by acquiring rights to a rapid flu test. I believe OraSure is very well positioned to begin 2011.”

For the year ended December 31, 2010, revenues decreased 3% compared to the year ended December 31, 2009, primarily as a result of lower sales of infectious disease products partially offset by an increase in sales of the Company’s cryosurgical systems products and an increase in licensing and product


development revenues. The decrease in the Company’s infectious disease revenues was largely due to lower international sales. This decrease was offset by higher sales of the Company’s Histofreezer® cryosurgical product to physician offices in the United States. Current year licensing and product development revenue includes $2.0 million in milestone payments received under the terms of a collaboration agreement for the development and promotion of the Company’s OraQuick® rapid HCV test.

For the quarter ended December 31, 2010, revenues decreased 10% compared to the quarter ended December 31, 2009, primarily as a result of lower sales of infectious disease products in the international marketplace and lower cryosurgical systems sales primarily due to the absence in the current quarter of stocking orders associated with the launch of the Company’s over-the-counter (“OTC”) cryosurgical product in Brazil.

The Company’s gross margin was 63% and 64% for the year and quarter ended December 31, 2010, respectively. This compares to gross margin of 61% for the full year 2009 and 59% for the quarter ended December 31, 2009. Full year 2010 gross margin increased largely as a result of the receipt of $2.0 million in milestone payments under the Company’s HCV collaboration agreement with Merck. Gross margin in the fourth quarter of 2010 benefited from a reduction in royalty expense related to the Company’s OraQuick® HIV product.

Operating expenses for the year ended December 31, 2010 were $50.7 million, a $5.2 million decrease from the $55.9 million reported in 2009. Prior year results include the $3.0 million impairment charge and $1.5 million litigation settlement expense mentioned above. Research and development costs were comparable year over year at $13.2 million and $13.4 million for 2010 and 2009, respectively. Sales and marketing expenses decreased slightly from $21.2 million in 2009 to $20.7 million in 2010 primarily due to lower relocation expenses. General and administrative costs remained relatively unchanged at $16.8 million in each year.

Fourth quarter operating expenses decreased $2.9 million from $15.8 million in 2009 to $12.9 million in the fourth quarter of 2010. Fourth quarter 2009 expenses included the $1.5 million litigation settlement expense mentioned above. Research and development expenses for the fourth quarter of 2010 decreased approximately $613,000 from the comparable period in 2009 as lower clinical trial expenses related to the Company’s OraQuick® HCV test were partially offset by higher costs related to the clinical development of the Company’s OraQuick® HIV OTC test. Sales and marketing expenses decreased approximately $854,000 in the fourth quarter of 2010 primarily as a result of lower market research and travel costs. General and administrative expenses for the fourth quarter of 2010 remained flat at approximately $4.0 million compared to $3.9 million for the fourth quarter of 2009.

In the full year and the fourth quarter of 2009, the Company recorded an income tax benefit of $622,000, primarily related to refundable alternative minimum taxes paid in previous years.


Cash, cash equivalents and short-term investments totaled $75.7 million and working capital was $77.8 million at December 31, 2010, compared to $79.7 million and $89.4 million, respectively, at December 31, 2009. This change in working capital reflects the reclassification of the Company’s remaining unpaid principal balance of its debt obligation to a current liability as a result of its maturity in June 2011 as well as the reduction of cash, cash equivalents and short-term investments. Cash flow provided by operating activities for the year ended December 31, 2010 was $3.9 million compared to $293,000 used in operating activities for the year ended December 31, 2009.

First Quarter 2011 Outlook

The Company expects total revenues for the first quarter of 2011 to range from approximately $16.75 million to $17.25 million and is projecting a net loss per share for the first quarter of 2011 of approximately $0.08.


Financial Data

OraSure Technologies, Inc.

 

    

Condensed Financial Data

(In thousands, except per-share data)

 
    

Unaudited

 
     Three months ended
December 31,
    Year ended
December 31,
 
     2010     2009     2010     2009  

Results of Operations

        

Revenues

   $ 18,817      $ 20,887      $ 75,015      $ 77,026   

Cost of products sold

     6,853        8,512        27,656        29,896   
                                

Gross profit

     11,964        12,375        47,359        47,130   
                                

Operating expenses:

        

Research and development

     4,048        4,661        13,192        13,371   

Sales and marketing

     4,830        5,684        20,727        21,224   

General and administrative

     4,018        3,982        16,794        16,848   

Litigation settlement

     —          1,451        —          1,451   

Impairment of patent and product rights

     —          —          —          3,028   
                                

Total operating expenses

     12,896        15,778        50,713        55,922   
                                

Operating loss

     (932     (3,403     (3,354     (8,792

Other income (expense), net

     (91     (54     (143     357   
                                

Loss before income taxes

     (1,023     (3,457     (3,497     (8,435

Income tax benefit

     —          (622     —          (622
                                

Net loss

   $ (1,023   $ (2,835   $ (3,497   $ (7,813
                                

Loss per share:

        

Basic and Diluted

   $ (0.02   $ (0.06   $ (0.08   $ (0.17
                                

Weighted average shares:

        

Basic and Diluted

     46,221        45,921        46,187        45,878   
                                

 

     Three months ended December 31,  
     Dollars      %
Change
    Percentage of
Total Revenues
 
     2010      2009        2010     2009  

Market Revenues (Unaudited)

            

Infectious disease testing

   $ 11,437       $ 12,691         (10 )%      61     61

Substance abuse testing

     2,886         3,137         (8     15        15   

Cryosurgical systems

     2,844         3,160         (10     15        15   

Insurance risk assessment

     1,355         1,604         (16     7        8   
                                    

Product revenues

     18,522         20,592         (10     98        99   

Licensing and product development

     295         295         —          2        1   
                                    

Total revenues

   $ 18,817       $ 20,887         (10 )%      100     100
                                    


     Year ended December 31,  
     Dollars      %
Change
    Percentage of
Total Revenues
 
     2010      2009        2010     2009  

Market Revenues (Unaudited)

            

Infectious disease testing

   $ 41,738       $ 46,098         (9 )%      55     60

Substance abuse testing

     11,671         12,026         (3     16        16   

Cryosurgical systems

     11,965         10,888         10        16        14   

Insurance risk assessment

     5,825         6,157         (5     8        8   
                                    

Product revenues

     71,199         75,169         (5     95        98   

Licensing and product development

     3,816         1,857         105        5        2   
                                    

Total revenues

   $ 75,015       $ 77,026         (3 )%      100     100
                                    

 

     Three months ended
December 31,
     %
Change
    Year ended
December 31,
     %
Change
 
      2010      2009        2010      2009     

OraQuick® Revenues

                

Domestic

   $ 10,137       $ 9,949         2   $ 38,218       $ 39,306         (3 )% 

International

     829         2,141         (61     1,919         4,511         (57
                                        

Total OraQuick® revenues

   $ 10,966       $ 12,090         (9 )%    $ 40,137       $ 43,817         (8 )% 
                                        
     Three months ended
December 31,
     %
Change
    Year ended
December 31,
     %
Change
 
      2010      2009        2010      2009     

Intercept® Revenues

                

Domestic

   $ 1,883       $ 1,972         (5 )%    $ 7,274       $ 7,405         (2 )% 

International

     454         479         (5     1,976         2,003         (1
                                        

Total Intercept® revenues

   $ 2,337       $ 2,451         (5 )%    $ 9,250       $ 9,408         (2 )% 
                                        
     Three months ended
December 31,
     %
Change
    Year ended
December 31,
     %
Change
 
      2010      2009        2010      2009     

Cryosurgical Systems Revenues

                

Professional domestic

   $ 1,492       $ 933         60   $ 5,967       $ 3,902         53

Professional international

     520         318         64        1,385         1,919         (28

Over-the-counter

     832         1,909         (56     4,613         5,067         (9
                                        

Total cryosurgical systems revenues

   $ 2,844       $ 3,160         (10 )%    $ 11,965       $ 10,888         10
                                        


      December 31, 2010      December 31, 2009  

Balance Sheets (Unaudited)

     
Assets      

Cash, cash equivalents and short-term investments

   $ 75,738       $ 79,670   

Accounts receivable, net

     12,471         13,693   

Inventories

     7,346         8,845   

Prepaid expenses

     1,930         2,610   

Property and equipment, net

     19,611         20,014   

Other non-current assets

     5,424         2,159   
                 

Total assets

   $ 122,520       $ 126,991   
                 
Liabilities and Stockholders’ Equity      

Current portion of long-term debt

   $ 7,791       $ 510   

Accounts payable

     2,899         3,370   

Accrued expenses

     8,987         11,503   

Long-term debt

     —           7,792   

Other liabilities

     —           9   

Stockholders’ equity

     102,843         103,807   
                 

Total liabilities and stockholders’ equity

   $ 122,520       $ 126,991   
                 

 

    

Year ended

December 31,

 
      2010      2009  

Additional Financial Data (Unaudited)

     

Capital expenditures

   $ 2,106       $ 1,200   

Depreciation and amortization

   $ 3,012       $ 3,050   

Cash flows provided by (used in) operating activities

   $ 3,887       $ (293

Accounts receivable – days sales outstanding

     61 days         65 days   

Conference Call

The Company will host a conference call and audio webcast to discuss the Company’s 2010 fourth quarter and full-year financial results, business developments and first quarter 2011 financial guidance, beginning today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will be Douglas A. Michels, President and Chief Executive Officer, and Ronald H. Spair, Chief Financial Officer and Chief Operating Officer. The call will include prepared remarks by management and a question and answer session.

In order to listen to the conference call, please either dial 877-348-9357 (Domestic) or 970-315-0488 (International) and reference Conference ID #41326273, or go to OraSure Technologies’ web site, www.orasure.com, and click on the Investor Info link. A replay of the call will be archived on OraSure Technologies’ web site shortly after the call has ended and will be available for seven days. A replay of the call can also be accessed until February 16, 2011, by


dialing 800-642-1687 (Domestic) or 706-645-9291 (International) and entering the Conference ID #41326273.

About OraSure Technologies

OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices and tests and other diagnostic products using proprietary technologies, including immunoassays and other in vitro diagnostic tests and other medical devices. These products are sold in the United States and certain foreign countries to clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. For more information on the Company, please visit www.orasure.com.

Important Information

This press release contains certain forward-looking statements, including with respect to expected revenues, loss per share, and expected clinical development, regulatory filings and approvals. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: ability to market and sell products, whether through an internal, direct sales force or third parties; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; failure of distributors or other customers to meet purchase forecasts or minimum purchase requirements for the Company’s products; impact of replacing distributors and success of direct sales efforts; inventory levels at distributors and other customers; impact of competitors, competing products and technology changes; impact of the economic downturn, high unemployment and poor credit conditions; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid testing or other products; changes in market acceptance of products based on product performance, extended shelf life or other factors; continued bulk purchases by customers, including governmental agencies, and the ability to fully deploy those purchases in a timely manner; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical product components; availability of related products produced by third parties or products required for use of our products; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; history of losses and ability to achieve sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of our stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other


technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; loss or impairment of sources of capital; ability to meet financial covenants in agreements with financial institutions; ability to retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; ability to identify, complete and realize the full benefits of potential acquisitions; and general political, business and economic conditions. These and other factors are discussed more fully in the Company’s Securities and Exchange Commission filings, including its registration statements, Annual Report on Form 10-K for the year ended December 31, 2009, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.

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