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8-K - FORM 8-K - ORASURE TECHNOLOGIES INCd623748d8k.htm
EX-99.2 - EX-99.2 - ORASURE TECHNOLOGIES INCd623748dex992.htm

Exhibit 99.1

 

LOGO

Company Contact:

Ronald H. Spair

Chief Financial Officer

610-882-1820

Investorinfo@orasure.com

www.orasure.com

OraSure Announces 2013 Third Quarter Financial Results

—  Quarterly Revenues Reach Record High  —

BETHLEHEM, PA – November 6, 2013 – (Globe Newswire) – OraSure Technologies, Inc. (NASDAQ: OSUR), a market leader in oral fluid diagnostics, today announced its consolidated financial results for the third quarter and nine months ended September 30, 2013.

Financial Highlights

 

    Consolidated net revenues for the third quarter of 2013 were $24.7 million, a 12% increase from the comparable quarter of 2012. Consolidated net revenues for the nine months ended September 30, 2013 were $70.2 million, a 7% increase from the comparable period of 2012. During the current quarter and nine month period, net product revenues increased 13% and 9%, respectively, compared to the year ago periods. These increases were primarily due to sales of the Company’s OraQuick® In-Home HIV test and record revenues from the Company’s molecular collection systems subsidiary, DNA Genotek (“DNAG”).

 

    Net revenues for the third quarter and first nine months of 2013 included $1.9 million and $5.6 million in gross sales of the OraQuick® In-Home HIV test, respectively. These gross sales were reduced by customer allowances for cooperative advertising, cash discounts and other allowances, resulting in net revenues of $1.8 million and $5.2 million recorded in each respective period. There were no sales recorded for this product in the comparable 2012 periods.

 

   

Net revenues generated by DNAG during the third quarter of 2013 were $5.0 million, a 48% increase from the comparable period in 2012. DNAG net revenues during the nine months ended September 30, 2013 were $13.6


 

million, a 36% increase from the comparable period in 2012. The increase in both periods was primarily the result of higher sales to commercial customers.

 

    Consolidated net loss for the third quarter of 2013 was $1.9 million, or $0.03 per share, which compares to a net loss of $2.4 million, or $0.04 per share, for the third quarter of 2012. Consolidated net loss for the nine months ended September 30, 2013 was $17.4 million, or $0.31 per share, which compares to a net loss of $9.2 million, or $0.18 per share, for the comparable period of 2012. The net loss for the third quarter and first nine months of 2013 included $1.9 million and $14.2 million in advertising and promotional expenses, respectively, associated with the Company’s OraQuick® In-Home HIV test.

“We are pleased with the Company’s record revenue performance for the third quarter,” said Douglas A. Michels, President and CEO of OraSure Technologies. “Our molecular collection systems business continues to deliver strong growth and we are encouraged by the higher sales of our OraQuick® HCV test. We have also launched a new targeted promotional campaign for the OraQuick® In-Home HIV test in an effort to accelerate growth of that important product line.”

Financial Results

Consolidated net product revenues for the third quarter and nine month periods of 2013 increased 13% and 9%, respectively, primarily as a result of higher sales of the Company’s infectious disease testing and molecular collection systems products. These increases were partially offset by lower sales of the Company’s substance abuse testing, cryosurgical systems and insurance risk assessment products.

Consolidated licensing and product development revenues for the third quarter of 2013 decreased to $147,000 from $386,000 for the third quarter of 2012 as a result of the expiration of certain patents licensed to a third party. Consolidated licensing and product development revenues for the nine months ended September 30, 2013 decreased to $623,000 from $1.9 million in the comparable period of the prior year, primarily due to the absence of a $1.0 million milestone payment received in the first quarter of 2012 under the Company’s HCV collaboration agreement with Merck. No similar payment was received during 2013 because the collaboration agreement with Merck was terminated in November 2012.

Consolidated gross margin for the three and nine months ended September 30, 2013 was 61% and 59%, respectively. Consolidated gross margin for the three and nine months ended September 30, 2012 was 63% and 64%, respectively. The current quarter gross margin was negatively impacted by higher royalties paid on sales of the Company’s OraQuick® HIV products and an unfavorable change in product mix partially offset by an improvement in overhead absorption and a

 

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decline in scrap and spoilage costs. Gross margin for the current nine month period was negatively impacted by the higher royalties, the change in product mix and the absence of the $1.0 million HCV milestone payment, partially offset by the improvement in overhead absorption.

Consolidated operating expenses remained relatively flat at $17.0 million during the third quarter of 2013 compared to $16.8 million in the comparable period of 2012. For the nine months ended September 30, 2013, consolidated operating expenses were $59.7 million, an increase over the $52.4 million reported for the nine months ended September 30, 2012. The increase for the first nine months of 2013 was primarily the result of higher promotional and advertising expenses associated with the Company’s OraQuick® In-Home HIV test. The current quarter and nine month period expenses included $1.9 million and $14.2 million of promotional and advertising costs related to this product, compared to $1.8 million and $4.7 million spent in the third quarter and first nine months of 2012, respectively.

For the three and nine months ended September 30, 2013, the Company recorded a Canadian income tax benefit of $127,000 and $786,000, respectively, associated with the loss before income taxes and certain Canadian research and development and investment tax credits at DNAG.

The Company’s cash balance totaled $82.6 million at September 30, 2013 compared to $87.9 million at December 31, 2012. Working capital was $92.1 million at September 30, 2013 compared to $103.5 million at December 31, 2012. For the nine months ended September 30, 2013, the Company used $3.1 million to fund operations, including the advertising and promotional activities related to the OraQuick® In-Home HIV test. Cash generated by operations in the third quarter of 2013 was $6.1 million.

Fourth Quarter 2013 Outlook

The Company expects consolidated net revenues to range from $27.5 to $28.0 million and is projecting a consolidated net loss of approximately $0.07 - $0.08 per share for the fourth quarter of 2013.

 

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Financial Data

Condensed Consolidated Financial Data

(In thousands, except per-share data)

Unaudited

 

     Three months ended     Nine months ended  
   September 30,     September 30,  
     2013     2012     2013     2012  

Results of Operations

        

Net revenues

   $ 24,671      $ 22,115      $ 70,172      $ 65,675   

Cost of products sold

     9,738        8,227        28,711        23,356   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     14,933        13,888        41,461        42,319   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Research and development

     2,670        2,994        8,720        9,551   

Sales and marketing

     8,981        8,602        35,224        25,490   

General and administrative

     5,342        5,220        15,742        17,398   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     16,993        16,816        59,686        52,439   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (2,060     (2,928     (18,225     (10,120

Other income (expense)

     41        (34     36        (267
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (2,019     (2,962     (18,189     (10,387

Income tax benefit

     (127     (527     (786     (1,138
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (1,892   $ (2,435   $ (17,403   $ (9,249
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss per share:

        

Basic and Diluted

   $ (0.03   $ (0.04   $ (0.31   $ (0.18
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares:

        

Basic and Diluted

     55,592        54,441        55,534        50,177   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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Summary of Revenues by Market and Product (Unaudited)

 

     Three Months Ended September 30,  
     Dollars            Percentage of
Total Net
Revenues
 

Market

   2013      2012      %
Change
    2013     2012  

Infectious disease testing

   $ 12,873       $ 10,718         20     52     48

Substance abuse testing

     2,092         2,331         (10     8        11   

Cryosurgical systems

     3,649         4,199         (13     15        19   

Molecular collection systems

     4,964         3,353         48        20        15   

Insurance risk assessment

     946         1,128         (16     4        5   
  

 

 

    

 

 

      

 

 

   

 

 

 

Net product revenues

     24,524         21,729         13        99        98   

Licensing and product development

     147         386         (62     1        2   
  

 

 

    

 

 

      

 

 

   

 

 

 

Net revenues

   $ 24,671       $ 22,115         12     100     100
  

 

 

    

 

 

      

 

 

   

 

 

 
     Nine Months Ended September 30,  
     Dollars            Percentage of
Total Net
Revenues
 

Market

   2013      2012      %
Change
    2013     2012  

Infectious disease testing

   $ 35,526       $ 30,880         15     51     47

Substance abuse testing

     6,455         7,305         (12     9        11   

Cryosurgical systems

     10,910         12,181         (10     16        19   

Molecular collection systems

     13,550         9,992         36        19        15   

Insurance risk assessment

     3,108         3,448         (10     4        5   
  

 

 

    

 

 

      

 

 

   

 

 

 

Net product revenues

     69,549         63,806         9        99        97   

Licensing and product development

     623         1,869         (67     1        3   
  

 

 

    

 

 

      

 

 

   

 

 

 

Net revenues

   $ 70,172       $ 65,675         7     100     100
  

 

 

    

 

 

      

 

 

   

 

 

 

 

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     Three Months Ended     Nine Months Ended  
     September 30 ,     September 30,  

OraQuick® Revenues

   2013      2012      %
Change
    2013      2012      %
Change
 

Domestic HIV

   $ 8,093       $ 8,527         (5 )%    $ 23,854       $ 25,106         (5 )% 

International HIV

     1,157         884         31        2,457         2,287         7   

Domestic HIV OTC

     1,762         —           N/A        5,196         —           N/A   

Domestic HCV

     653         678         (4     1,772         1,958         (9

International HCV

     924         241         283        1,409         734         92   
  

 

 

    

 

 

      

 

 

    

 

 

    

Net OraQuick® revenues

   $ 12,589       $ 10,330         22   $ 34,688       $ 30,085         15
  

 

 

    

 

 

      

 

 

    

 

 

    
     Three Months Ended     Nine Months Ended  
     September 30,     September 30,  

Intercept® Revenues

   2013      2012      %
Change
    2013      2012      %
Change
 

Domestic

   $ 1,495       $ 1,499         0   $ 4,240       $ 4,981         (15 )% 

International

     29         279         (90     385         616         (38
  

 

 

    

 

 

      

 

 

    

 

 

    

Net Intercept® revenues

   $ 1,524       $ 1,778         (14 )%    $ 4,625       $ 5,597         (17 )% 
  

 

 

    

 

 

      

 

 

    

 

 

    
     Three Months Ended     Nine Months Ended  
     September 30,     September 30,  

Cryosurgical Systems Revenues

   2013      2012      %
Change
    2013      2012      %
Change
 

Professional domestic

   $ 1,803       $ 2,025         (11 )%    $ 4,192       $ 5,342         (22 )% 

Professional international

     435         453         (4     1,039         1,110         (6

Over-the-Counter

     1,411         1,721         (18     5,679         5,729         (1
  

 

 

    

 

 

      

 

 

    

 

 

    

Net cryosurgical systems revenues

   $ 3,649       $ 4,199         (13 )%    $ 10,910       $ 12,181         (10 )% 
  

 

 

    

 

 

      

 

 

    

 

 

    

 

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Condensed Consolidated Balance Sheets (Unaudited)    September 30, 2013      December 31, 2012  
Assets      

Cash

   $ 82,590       $ 87,888   

Accounts receivable, net

     14,292         17,545   

Inventories

     12,000         12,758   

Other current assets

     2,516         2,212   

Property and equipment, net

     17,989         18,546   

Intangible assets, net

     23,701         27,207   

Goodwill

     24,510         25,445   

Other non-current assets

     614         124   
  

 

 

    

 

 

 

Total assets

   $ 178,212       $ 191,725   
  

 

 

    

 

 

 
Liabilities and Stockholders’ Equity      

Accounts payable

   $ 3,859       $ 3,380   

Deferred revenue

     4,472         5,580   

Accrued expenses

     10,995         7,960   

Other non-current liabilities

     539         89   

Deferred income taxes

     3,456         4,401   

Stockholders’ equity

     154,891         170,315   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 178,212       $ 191,725   
  

 

 

    

 

 

 

 

     Nine months ended  
   September 30,  
Additional Financial Data (Unaudited)    2013      2012  

Capital expenditures

   $ 1,696       $ 1,402   

Depreciation and amortization

   $ 4,846       $ 5,455   

Stock based compensation

   $ 4,187       $ 3,845   

Cash used in operating activities

   $ 3,142       $ 4,006   

Conference Call

The Company will host a conference call and audio webcast to discuss the Company’s 2013 third quarter financial results, business developments and financial guidance for the fourth quarter of 2013, 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, Ronald H. Spair, Chief Financial Officer and Chief Operating Officer, and Kathleen Weber, Senior Vice President and General Manager, Consumer Products. 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 #87563319 or go to

 

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OraSure Technologies’ web site, www.orasure.com, and click on the Investor Relations page. Please click on the webcast link and follow the prompts for registration and access 10 minutes prior to the call. 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 13, 2013, by dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and entering the Conference ID #87563319.

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In July 2012, the Company received approval from the U.S. Food and Drug Administration to sell its OraQuick® In-Home HIV Test directly to consumers in the over-the-counter (OTC) market – making it the first and only rapid OTC HIV test approved in the U.S. In addition, the Company is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. OraSure’s portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians’ offices, and commercial and industrial entities. The Company’s products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. For more information on OraSure Technologies, please visit www.orasure.com.

Important Information

This press release contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. 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 our internal, direct sales force or third parties; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; 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; 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; inventory levels at distributors and other customers; ability to integrate and realize the full benefits of the Company’s acquisition of DNA Genotek; ability of DNA Genotek to achieve its financial and strategic objectives and continue to increase its revenues; ability to identify, complete, integrate and realize the full

 

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benefits of future acquisitions; impact of competitors, competing products and technology changes; impact of negative economic conditions and high unemployment; 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, including the OraQuick® In-Home HIV test; market acceptance of oral fluid testing or other products; changes in market acceptance of products based on product performance or other factors; 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 products and components; availability of related products produced by third parties or products required for use of our products; 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; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; 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; 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, 2012, 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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