Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 8-K

 


CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November 1, 2006

 


OraSure Technologies, Inc.

(Exact Name of Registrant as Specified in Charter)

 


 

Delaware   001-16537   36-4370966

(State or Other Jurisdiction

of Incorporation)

  (Commission File Number)  

(I.R.S. Employer

Identification No.)

 

220 East First Street

Bethlehem, Pennsylvania

  18015-1360
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: 610-882-1820

 


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



Item 2.02 – Results of Operations and Financial Condition.

On November 1, 2006, OraSure Technologies, Inc. issued a press release announcing its financial results for the quarter and nine months ended September 30, 2006. A copy of the press release is attached as Exhibit 99 to this Form 8-K and is incorporated herein by reference.

Item 9.01 – Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
Number
 

Description

99   Press Release, dated November 1, 2006, announcing financial results of OraSure Technologies, Inc. for the quarter and nine months ended September 30, 2006.


Signatures

Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

  ORASURE TECHNOLOGIES, INC.
Date: November 1, 2006   By:  

/s/ Jack E. Jerrett

    Jack E. Jerrett
    Senior Vice President, General Counsel and Secretary


Index to Exhibits

 

Exhibit No.  

Description

99   Press Release, dated November 1, 2006, announcing financial results of OraSure Technologies, Inc. for the quarter and nine months ended September 30, 2006.
Press Release

Exhibit 99

LOGO

Company Contact:

Ronald H. Spair

Chief Financial Officer

610-882-1820

Investorinfo@orasure.com

www.orasure.com

OraSure Announces Third Quarter Financial Results

BETHLEHEM, PA – November 1, 2006 – (BW HealthWire) – OraSure Technologies, Inc. (NASDAQ: OSUR), a market leader in oral fluid diagnostics, today announced revenues of $17.6 million for the quarter ended September 30, 2006, compared to $18.1 million in revenues recorded for the comparable period in 2005.

The Company’s net income was $2.1 million, or $0.05 per share on a basic and fully-diluted basis, for the third quarter of 2006, which includes charges for stock option expense and a provision for income taxes, neither of which were included in the Company’s 2005 results. Excluding these two charges, net income for the third quarter of 2006 would have been $4.3 million, or $0.09 per share on a fully-diluted basis. These results compare to net income of $3.8 million, or $0.08 per share on a basic and fully-diluted basis, during the third quarter of 2005.

For the nine months ended September 30, 2006, the Company had revenues of $50.4 million compared to revenues of $51.3 million for the nine months ended September 30, 2005. The Company recorded net income of $4.2 million, or $0.09 per share on a basic and fully-diluted basis, for the nine months ended September 30, 2006, which includes charges for stock option expense and a provision for income taxes. Excluding these two charges, net income for the nine months ended September 30, 2006 would have been $10.0 million, or $0.21 per share on a fully-diluted basis. These results compare to net income of $6.8 million, or $0.15 per share on a basic and fully-diluted basis, during the nine months ended September 30, 2005, which excluded costs related to stock options and a provision for income taxes.

- more -


“We are pleased with the Company’s financial performance for the third quarter,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “Our financial results exceeded our expectations and were driven primarily by continued strong performance of our infectious disease testing business along with the increased sales of our substance abuse testing and insurance risk assessment products. Offsetting these increases was a reduction in our cryosurgical systems sales.”

Gross margin in both the third quarters of 2006 and 2005 was 64%.

Operating expenses for the third quarter of 2006 increased to $8.8 million from $8.4 million in the comparable period in 2005. This increase was primarily attributable to stock option expense, increased research and development expenses and costs related to the implementation of a new enterprise resource planning system, offset by lower legal and advertising costs. Operating expenses for the nine months ended September 30, 2006 were $27.3 million, compared to $25.2 million for the comparable period in 2005.

Cash, cash equivalents and short-term investments totaled $89.5 million and working capital was $98.1 million at September 30, 2006, compared to $77.6 million and $90.7 million, respectively, at December 31, 2005.

Cash flow from operations was $5.9 million for the third quarter of 2006, up from the $3.6 million reported for the third quarter of 2005. Cash flow from operations for the nine months ended September 30, 2006 was $14.1 million, compared to $8.5 million for the comparable period in 2005.

Due to the better than expected financial performance in the third quarter of 2006, the Company is raising its 2006 full year, fully-diluted earnings per share guidance to between $0.10 - $0.11 per share as a result of an additional expected $0.01 - $0.02 per share of earnings in the fourth quarter of 2006. The fourth quarter earnings projection is based on attainment of projected revenues of between $17.0 million and $17.5 million for the quarter, resulting in 2006 full-year projected revenues of between approximately $67.5 million and $68.0 million.


Condensed Financial Data

(In thousands, except per-share

data and percentages)

Unaudited

 

     Three months ended
September 30,
   Nine months ended
September 30,
     2006    2005    2006    2005

Results of Operations

           

Revenues

   $ 17,639    $ 18,077    $ 50,421    $ 51,335

Cost of products sold

     6,365      6,432      18,516      20,773
                           

Gross profit

     11,274      11,645      31,905      30,562

Operating expenses:

           

Research and development

     1,753      1,298      5,150      3,750

Acquired in-process technology

     —        —        600      —  

Sales and marketing

     3,632      3,965      11,977      12,289

General and administrative

     3,445      3,168      9,545      9,132
                           

Total operating expenses

     8,830      8,431      27,272      25,171
                           

Operating income

     2,444      3,214      4,633      5,391

Other income, net

     955      594      2,642      1,421

Income tax provision

     1,264      —        3,033      —  
                           

Net income

   $ 2,135    $ 3,808    $ 4,242    $ 6,812
                           

Earnings per share

           

Basic

   $ 0.05    $ 0.08    $ 0.09    $ 0.15
                           

Diluted

   $ 0.05    $ 0.08    $ 0.09    $ 0.15
                           

Shares used in computing earnings per share:

           

Basic

     45,922      45,372      45,888      44,936
                           

Diluted

     47,247      46,676      47,712      45,850
                           
     Three months ended
September 30,
   Nine months ended
September 30,
     2006    2005    2006    2005

Reconciliation of Non-GAAP Financial Measures

           

Net income – before charges

   $ 4,344    $ 3,808    $ 9,992    $ 6,812

Stock option expense

     945      —        2,717      —  

Income tax provision

     1,264      —        3,033      —  
                           

Net income – GAAP basis

   $ 2,135    $ 3,808    $ 4,242    $ 6,812
                           

Diluted earnings per share – before charges

   $ 0.09    $ 0.08    $ 0.21    $ 0.15

Stock option expense

     0.02      —        0.06      —  

Income tax provision

     0.02      —        0.06      —  
                           

Diluted earnings per share – GAAP basis

   $ 0.05    $ 0.08    $ 0.09    $ 0.15
                           


     Three months ended September 30,  
     Dollars    %
Change
    Percentage of
Total Revenues
 
     2006    2005      2006     2005  
Market Revenues             

Infectious disease testing

   $ 7,536    $ 7,037    7 %   42 %   39 %

Substance abuse testing

     4,213      3,595    17     24     20  

Cryosurgical systems

     4,025      6,143    (34 )   23     34  

Insurance risk assessment

     1,734      1,275    36     10     7  
                            

Product revenues

     17,508      18,050    (3 )   99     100  

Licensing and product development

     131      27    385     1     —    
                            

Total revenues

   $ 17,639    $ 18,077    (2 )%   100 %   100 %
                            
     Nine months ended September 30,  
     Dollars    %
Change
    Percentage of
Total Revenues
 
     2006    2005      2006     2005  

Market Revenues

            

Infectious disease testing

   $ 21,239    $ 19,672    8 %   42 %   38 %

Substance abuse testing

     11,694      10,060    16     23     20  

Cryosurgical systems

     13,063      16,002    (18 )   26     31  

Insurance risk assessment

     4,128      5,364    (23 )   8     11  
                            

Product revenues

     50,124      51,098    (2 )   99     100  

Licensing and product development

     297      237    25     1     —    
                            

Total revenues

   $ 50,421    $ 51,335    (2 )%   100 %   100 %
                            

Balance Sheets

 

     September 30,
2006
   December 31,
2005

Assets

     

Cash, cash equivalents and short-term investments

   $ 89,534    $ 77,620

Accounts receivable, net

     10,236      11,602

Inventories

     4,812      4,128

Current portion of deferred income taxes

     3,511      6,504

Other current assets

     1,646      1,553

Property and equipment, net

     16,478      5,815

Deferred income taxes

     20,580      20,205

Other non-current assets

     2,938      3,320
             

Total assets

   $ 149,735    $ 130,747
             

Liabilities and Stockholders’ Equity

     

Current portion of long-term debt

   $ 636    $ 456

Accounts payable

     2,519      2,547

Accrued expenses

     8,526      7,734

Long-term debt, less current portion

     10,303      884

Other liabilities

     375      207

Stockholders’ equity

     127,376      118,919
             

Total liabilities and stockholders’ equity

   $ 149,735    $ 130,747
             


Non-GAAP Financial Measures

Net income - before charges and diluted earnings per share - before charges, each exclude the impact of stock option expensing and income tax provisions. These financial measures should not be considered an alternative to net income or diluted earnings per share, respectively, which are indicators of operating performance determined in accordance with GAAP. OraSure Technologies believes that net income - before charges and diluted earnings per share - before charges, although non-GAAP financial measures, are also useful and meaningful to investors because they provide investors with the Company’s underlying earnings performance as another criterion in making their investment decisions. OraSure’s management also uses these calculations in measuring certain corporate performance goals. Other companies may use different measures to present financial information.

Conference Call

The Company will host a conference call and audio webcast today to discuss the Company’s third quarter 2006 financial results and to provide an update on major business objectives, beginning 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 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), 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 November 08, 2006, by dialing 800-642-1687 (Domestic) or 706-645-9291 (International) and entering the Conference ID #8995949.

About OraSure Technologies

OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices and tests and other diagnostic products using its 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 and earnings per share. Actual results could be significantly different. Factors that could affect results include the ability to market and sell products; changes in relationships 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 our products; impact of competitors, competing products and technology changes; ability to develop, commercialize and market new products; market acceptance of oral fluid testing or other new products or technology; changes in market acceptance 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; ability to obtain, and timing and cost of obtaining, necessary regulatory approval 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; 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; 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, patent infringement, 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, 2005, 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.

# # #