EX-99 2 dex99.htm PRESS RELEASE Press Release

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 2007 Financial Results

- Annual Revenues Reach Record Level With 21% Growth Over 2006 -

BETHLEHEM, PA – February 12, 2008 – (BW HealthWire) – OraSure Technologies, Inc. (NASDAQ: OSUR), a market leader in oral fluid diagnostics, today announced revenues of $82.7 million and $19.8 million for the year and quarter ended December 31, 2007, respectively. This compares to revenues of $68.2 million and $17.7 million for the year and quarter ended December 31, 2006, respectively.

The Company reported net income of $2.5 million, or $0.05 per share on a fully-diluted basis, for the full year 2007. These results compare to net income of $5.3 million, or $0.11 per share on a fully-diluted basis, for the full year 2006. Net income for the full year 2007 included a $1.4 million pre-tax gain on sale of an investment in a privately-held nonaffiliated company.

For the quarter ended December 31, 2007, the Company reported net income of $27,000 representing break-even earnings per share on a fully-diluted basis. These results compare to net income of $1.0 million, or $0.02 per share on a fully-diluted basis, for the quarter ended December 31, 2006.

For the year ended December 31, 2007, increased sales of the Company’s OraQuick® rapid HIV-1/2 antibody tests and over-the-counter (“OTC”) cryosurgery products, together with an increase in funded research and development related to the Company’s rapid Hepatitis C (“HCV”) test, contributed to the 21% increase in total revenue. Revenue for the quarter ended December 31, 2007 increased 12%, also as a result of increased sales of the Company’s OraQuick® tests and OTC cryosurgery products, as well as increased sales in the insurance risk assessment market. These increases for the quarter were partially offset by a decrease in sales of the Company’s Intercept® oral fluid drug testing product compared to 2006.


“We are pleased with the robust revenue increase delivered in 2007, and in particular with the continued growth of our infectious disease business,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “We believe the OraQuick® rapid HIV test will continue to drive significant growth in the future. During 2007, we also expanded our international business and continued to build the groundwork for our future success by making significant progress in the clinical development of a rapid HIV test for home use and a rapid Hepatitis C test for professional use.”

The Company’s gross margins were 61% and 58% for the full year 2007 and quarter ended December 31, 2007, respectively. Gross margins decreased from 64% for the full year 2006 and from 65% for the quarter ended December 31, 2006. The decrease in gross margin for the year was largely due to an increase in inventory scrap expenses, higher product support costs and a less favorable product mix. The decrease for the fourth quarter was largely due to a less favorable product mix and a higher unit cost associated with the introduction of a new cryosurgical device in the European OTC Market. The 2006 fourth quarter and full year margins also benefited from a favorable adjustment to royalty expense as the result of a re-negotiated patent license.

For the full year 2007, operating expenses increased to $51.5 million from $37.9 million in 2006. Operating expenses for the quarter ended December 31, 2007 were $13.0 million, compared to $10.7 million for the comparable period in 2006. These increases were primarily attributable to higher research and development costs associated with the development and clinical work for an OraQuick® rapid HIV test for home use and an OraQuick® hepatitis C test for professional use, higher staffing related costs and increased advertising reimbursement expense related to the Company’s international OTC cryosurgical product. Operating expenses for the full year 2007 were also higher due to increased legal expenses related to the dispute with Prestige Brands, which was resolved in the fourth quarter of 2007.

Cash flow from operating activities was $11.5 million in 2007, compared to $16.9 million reported in 2006. The decrease was primarily the result of lower net income and increases in inventories and accounts receivable, partially offset by an increase in accounts payable and accrued expenses.

Cash, cash equivalents and short-term investments totaled $95.6 million and working capital was $105.6 million at December 31, 2007, compared to $91.0 million and $96.0 million, respectively, at December 31, 2006.

Full Year and First Quarter 2008 Outlook

The Company expects total revenues for 2008 to range from approximately $90.0 to $92.0 million. This projection does not include the amount payable under the Schering-Plough settlement for past sales which will be recorded as other income, nor does it include


any contribution in 2008 from the reintroduction of a cryosurgical wart treatment product in the U.S. OTC market or launch of an OTC cryosurgical product line extension for which the Company is seeking FDA 510(k) clearance. The timing and potential magnitude of any revenues from these cryosurgical products are not predictable at this time. The Company does not include items in its guidance unless it believes the related revenues are likely to be achieved.

The Company expects to increase its Research and Development expenditures for 2008 to approximately $21.0 million, representing an increase of $7.0 million or approximately $0.08 per share over 2007. As a result, the Company expects to achieve fully diluted earnings per share for 2008 of approximately $0.05 to $0.07.

For the first quarter of 2008, revenues are expected to range from approximately $18.0 to $18.5 million with sequential growth in infectious disease and substance abuse testing revenues compared to the fourth quarter of 2007, offset by lower cryosurgical revenues as a result of seasonality and the absence of U.S. OTC cryosurgical sales. The Company is currently projecting fully-diluted earnings per share for the first quarter of 2008 of approximately $0.03 to $0.04.


Condensed Financial Data

(In thousands, except per-share

data and percentages)

Unaudited

     Three months ended
December 31,
   Year ended
December 31,
     2007     2006    2007     2006

Results of Operations

         

Revenues

   $ 19,809     $ 17,734    $ 82,686     $ 68,155

Cost of products sold

     8,281       6,240      32,403       24,756
                             

Gross profit

     11,528       11,494      50,283       43,399
                             

Operating expenses:

         

Research and development

     4,240       2,898      14,136       8,648

Sales and marketing

     5,063       3,945      20,062       15,921

General and administrative

     3,668       3,885      17,304       13,367
                             

Total operating expenses

     12,971       10,728      51,502       37,936
                             

Operating income (loss)

     (1,443 )     766      (1,219 )     5,463

Other income, net

     1,070       1,020      5,513       3,599
                             

Pre-tax income (loss)

     (373 )     1,786      4,294       9,062

Income tax provision (benefit)

     (400 )     761      1,821       3,794
                             

Net income

   $ 27     $ 1,025    $ 2,473     $ 5,268
                             

Earnings per share

         

Basic

   $ —       $ 0.02    $ 0.05     $ 0.11
                             

Diluted

   $ —       $ 0.02    $ 0.05     $ 0.11
                             

Weighted average shares:

         

Basic

     46,625       45,974      46,325       45,910
                             

Diluted

     47,336       46,440      46,878       46,580
                             

 

     Three months ended December 31,  
     Dollars    %
Change
    Percentage of
Total Revenues
 
     2007    2006      2007     2006  

Market Revenues

            

Infectious disease testing

   $ 9,444    $ 7,943    19 %   48 %   45 %

Substance abuse testing

     3,390      4,058    (16 )   17     23  

Cryosurgical systems

     5,343      4,269    25     27     24  

Insurance risk assessment

     1,605      1,437    12     8     8  
                                

Product revenues

     19,782      17,707    12     100     100  

Licensing and product development

     27      27    —       —       —    
                                

Total revenues

   $ 19,809    $ 17,734    12 %   100 %   100 %
                                


     Year ended December 31,  
     Dollars    %
Change
    Percentage of
Total Revenues
 
     2007    2006      2007     2006  

Market Revenues

            

Infectious disease testing

   $ 35,791    $ 29,180    23 %   43 %   43 %

Substance abuse testing

     15,789      15,752    —       19     23  

Cryosurgical systems

     23,533      17,333    36     28     25  

Insurance risk assessment

     5,464      5,565    (2 )   7     8  
                                

Product revenues

     80,577      67,830    19     97     99  

Licensing and product development

     2,109      325    549 %   3     1  
                                

Total revenues

   $ 82,686    $ 68,155    21 %   100 %   100 %
                                

 

     Three months ended
December 31,
   %
Change
    Year ended
December 31,
   %
Change
 
     2007    2006      2007    2006   

OraQuick® Revenues

                

Direct to U.S. Public Health

   $ 5,460    $ 4,475    22 %   $ 19,799    $ 15,268    30 %

Abbott

     2,018      1,674    21       8,103      6,897    17  

SAMHSA

     —        150    N/A       339      406    (17 )

CDC

     —        282    N/A       1,125      1,291    (13 )

International

     1,181      509    132 %     3,291      1,694    94  
                                        

Total OraQuick® revenues

   $ 8,659    $ 7,090    22 %   $ 32,657    $ 25,556    28 %
                                        

 

     Three months ended
December 31,
   %
Change
    Year ended
December 31,
   %
Change
 
     2007    2006      2007    2006   

Intercept® Revenues

                

Workplace testing

   $ 1,282    $ 1,871    (31 )%   $ 6,650    $ 6,616    1 %

Criminal Justice

     622      600    4       2,570      2,398    7  

International

     431      636    (32 )     2,188      2,314    (5 )

Direct

     264      200    32       1,003      728    38  
                                        

Total Intercept® revenues

   $ 2,599    $ 3,307    (21 )%   $ 12,411    $ 12,056    3 %
                                        

 

     Three months ended
December 31,
   %
Change
    Year ended
December 31,
   %
Change
 
     2007    2006      2007    2006   

Cryosurgery Revenues

                

Professional domestic

   $ 1,806    $ 1,203    50 %   $ 5,247    $ 5,360    (2 )%

Professional international

     798      788    1       2,349      2,284    3  

OTC domestic

     650      1,216    (47 )     6,237      5,174    21  

OTC international

     2,089      1,062    97       9,700      4,515    115 %
                                        

Total cryosurgery revenues

   $ 5,343    $ 4,269    25 %   $ 23,533    $ 17,333    36 %
                                        


     December 31, 2007    December 31, 2006

Balance Sheets

     

Assets

     

Cash, cash equivalents and short-term investments

   $ 95,566    $ 91,001

Accounts receivable, net

     11,296      10,357

Inventories

     9,410      5,534

Current deferred income taxes

     5,061      3,676

Other current assets

     2,744      1,990

Property and equipment, net

     20,911      17,375

Deferred income taxes

     17,266      19,846

Other non-current assets

     5,387      6,786
             

Total assets

   $ 167,641    $ 156,565
             

Liabilities and Stockholders’ Equity

     

Current portion of long-term debt

   $ 557    $ 609

Accounts payable

     5,905      3,312

Accrued expenses

     11,996      12,658

Long-term debt

     8,818      10,031

Other liabilities

     311      451

Stockholders’ equity

     140,054      129,504
             

Total liabilities and stockholders’ equity

   $ 167,641    $ 156,565
             

 

     Year ended December 31,
     2007    2006

Additional Financial Data

     

Capital expenditures

   $ 5,372    $ 12,643

Depreciation and amortization

   $ 2,736    $ 1,923

Accounts receivable – days sales outstanding

     50 days      55 days

Conference Call

The Company will host a conference call and audio webcast to discuss the Company’s 2007 fourth quarter and full-year financial results, business developments and 2008 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 888-742-2024 (Domestic) or 706-643-0033 (International) and reference Conference ID #32848688, 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 19, 2008, by dialing 800-642-1687 (Domestic) or 706-645-9291 (International) and entering the Conference ID #32848688.


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 revenues, net income and products. Actual results could be significantly different. Factors that could affect results include the ability to market and sell products; changes in relationships, including disputes or disagreements, with strategic partners 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 competitors, competing products and technology changes; ability to develop, commercialize and market new products; market acceptance of oral fluid testing, rapid point-of-care testing or other products; changes in market acceptance of products based on product performance; 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 and legal requirements; history of losses and ability to achieve sustained profitability; volatility of our stock price; uncertainty relating to patent protection; 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; loss or impairment of sources of capital or investments; ability to meet financial covenants in agreements with financial institutions; ability to retain qualified personnel; exposure to patent infringement, 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 complete consolidation or restructuring activities; 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 Securities and Exchange Commission (“SEC”) filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the


year ended December 31, 2006, its Quarterly Reports on Form 10-Q, and its other filings with the SEC. Although forward-looking statements help to provide complete 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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