OraSure Announces 2013 First Quarter Financial Results

OraSure Announces 2013 First Quarter Financial Results

BETHLEHEM, Pa., May 8, 2013 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc.
(Nasdaq:OSUR), a market leader in oral fluid diagnostics, today announced its
consolidated financial results for the first quarter of 2013.

Quarterly Highlights

  *Consolidated net revenues were $21.2 million for the first quarter of
    2013, a 1% increase from the comparable quarter of 2012. Net product
    revenues increased 6% primarily due to sales of the Company's OraQuick®
    In-Home HIV test and higher sales from the Company's molecular collection
    systems subsidiary, DNA Genotek ("DNAG").
    
  *Included in the 2013 first quarter net revenues were $1.5 million in gross
    sales of the OraQuick® In-Home HIV test, which were reduced by customer
    allowances for cooperative advertising, cash discounts and other
    allowances, resulting in net revenues of $1.4 million recorded for the
    period.Most revenue for this product is currently recognized upon the
    consummation of a sale to a retail customer either in a store or over the
    internet.
    
  *Net revenues generated by DNAG during the first quarter of 2013 were $3.9
    million, a 19% increase from the comparable period in 2012. This increase
    was primarily the result of higher sales to commercial customers.
    
  *Consolidated net loss for the first quarter of 2013 was $10.2 million, or
    $0.18 per share, which compares to a net loss of $3.3 million, or $0.07
    per share, for the first quarter of 2012.The net loss for the first
    quarter of 2013 included $6.9 million in advertising and promotional
    expenses for the Company's newly-launched OraQuick® In-Home HIV test.

"We are pleased to see the first quarter performance by our molecular
collection systems business and the increasing sales of our OraQuick® In-Home
HIV test," said Douglas A. Michels, President and Chief Executive Officer of
OraSure Technologies, Inc. "We continue to refine our advertising and
promotion strategies as we learn more about how consumers are responding to
the availability of our In-Home HIV test."

Financial Results

Consolidated net product revenues for the quarter increased 6%, primarily as a
result of the higher sales of the Company's molecular collection systems,
infectious disease testing, and substance abuse testing products.These
increases were partially offset by lower sales of the Company's cryosurgical
systems and insurance risk assessment products.

Consolidated licensing and product development revenues for the first quarter
of 2013 decreased to $202,000 from $1.2 million in the first quarter of 2012.
This decrease was primarily attributed 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 in the
first quarter of 2013.

Consolidated gross margin for the three months ended March 31, 2013 was 57%
compared to 66% for the three months ended March 31, 2012. The current quarter
gross margin was negatively impacted by a change in product mix, the absence
in the current quarter of the $1.0 milestone payment received in the first
quarter of 2012, higher royalties paid on sales of the Company's OraQuick®
products, and an increase in scrap, spoilage, and unabsorbed overhead costs as
a result of production issues that were identified and corrected in the
current quarter.

Consolidated operating expenses increased to $22.6 million for the first
quarter of 2013, from $17.4 million in the comparable period of 2012. This
increase was primarily the result of higher promotional and advertising
expense associated with the Company's OraQuick® In-Home HIV test.The current
quarter expenses included $6.9 million of promotional and advertising costs
related to this product compared to $1.0 million spent on launch preparation
costs in the first quarter of 2012.

For the three months ended March 31, 2013 and 2012, the Company recorded an
income tax benefit of $410,000 and $521,000, respectively, associated with the
loss before income taxes and certain Canadian research and development and
investment tax credits at DNAG.

Cash totaled $79.3 million at March 31, 2013 compared to $87.9 million at
December 31, 2012.Working capital was $94.9 million at March 31, 2013
compared to $103.5 million at December 31, 2012.For the three months ended
March 31, 2013, the Company used $7.7 million to fund operations, including
the advertising and promotional activities related to the OraQuick® In-Home
HIV test.

Second Quarter 2013 Outlook

The Company expects consolidated net revenues to range from $23.5 to $24.0
million and is projecting a consolidated net loss of approximately $0.15 -
$0.16 per share for the second quarter of 2013.

Financial Data

Condensed Consolidated Financial Data
(In thousands, except per-share data)
                                     
Unaudited
                          
                          Three months ended
                          March 31,
                          2013        2012
Results of Operations                 
Net revenues               $21,164   $20,944
Cost of products sold      9,135      7,212
Gross profit               12,029     13,732
Operating expenses:                   
Research and development   3,357      3,444
Sales and marketing        13,874     7,874
General and administrative 5,387      6,066
Total operating expenses   22,618     17,384
Operating loss             (10,589)   (3,652)
Other expense              (47)       (121)
Loss before income taxes   (10,636)   (3,773)
Income tax benefit         (410)      (521)
Net loss                   $(10,226) $(3,252)
Loss per share:                       
Basic and Diluted          $(0.18)   $(0.07)
                                     
Weighted average shares:              
Basic and Diluted          55,449      47,807


Summary of Revenues by Market and Product (Unaudited)
                                                               
                                 Three Months Ended March 31,
                                                             Percentage of
                                 Dollars                   Total Net
                                                             Revenues
Market                            2013      2012      %      2013   2012
                                                      Change
                                                               
Infectious disease testing        $10,687 $9,776  9%     49%    47%
Substance abuse testing           2,249    2,087    8      11     10
Cryosurgical systems              3,085    3,478    (11)   15     16
Molecular collection systems      3,932    3,298    19     19     16
Insurance risk assessment         1,009    1,099    (8)    5      5
Net product revenues              20,962   19,738   6      99     94
Licensing and product development 202      1,206    (83)   1      6
Net revenues                      $21,164 $20,944 1%     100%   100%

                      
                      Three Months Ended
                      March 31,
OraQuick^® Revenues    2013      2012     %
                                          Change
                                       
Domestic HIV           $7,672  $8,148 (6)%
International HIV      554      660     (16)
Domestic HIV OTC       1,442    --      N/A
Domestic HCV           428      536     (20)
International HCV      240      282     (15)
Net OraQuick® revenues $ 10,336 $9,626 7%

                       
                       Three Months Ended
                       March 31,
Intercept^® Revenues    2013     2012     %
                                          Change
                                       
Domestic                $1,274 $1,523 (16)%
International           388     46      743
Net Intercept® revenues $1,662 $1,569 6%

                                 
                                 Three Months Ended
                                 March 31,
Cryosurgical Systems Revenues     2013     2012     %
                                                    Change
                                                 
Professional domestic             $891   $1,371 (35)%
Professional international        348     287     21
Over-the-Counter                  1,846   1,820   1
Net cryosurgical systems revenues $3,085 $3,478 (11)%

                                                           
Condensed Consolidated Balance                March 31, 2013 December 31, 2012
Sheets(Unaudited)
Assets                                                      
                                                           
Cash                                          $79,276      $87,888
Accounts receivable, net                      16,955        17,545
Inventories                                   13,056        12,758
Other current assets                          3,599         2,212
Property and equipment, net                   18,297        18,546
Intangible assets, net                        25,749        27,207
Goodwill                                      24,823        25,445
Other non-current assets                      281           124
Total assets                                  $182,036     $191,725
                                                           
Liabilities and Stockholders' Equity                        
Accounts payable                              $5,622       $3,380
Deferred revenue                              5,611         5,580
Accrued expenses                              6,756         7,960
Other non-current liabilities                 249           89
Deferred income taxes                         3,881         4,401
Stockholders' equity                          159,917       170,315
Total liabilities and stockholders' equity    $182,036     $191,725

                                     
                                     Three months ended
                                     March 31,
Additional Financial Data(Unaudited) 2013      2012
                                              
Capital expenditures                  $480    $306
Depreciation and amortization         $1,602  $1,809
Stock based compensation              $1,394  $1,192
Cash used in operating activities     $7,674  $1,356

Conference Call

The Company will host a conference call and audio webcast to discuss the
Company's 2013 first quarter financial results, business developments and
financial guidance for the second 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
#42321505 or go to 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 May 15, 2013, by dialing 855-859-2056 (Domestic) or
404-537-3406 (International) and entering the Conference ID #42321505.

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 for the Company's OraQuick® In-Home HIV Test for sale
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 an 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; ability to identify, complete, integrate
and realize the full benefits of future acquisitions; 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,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, extended shelf life 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.

CONTACT: Company Contact:

         Ronald H. Spair
         Chief Financial Officer
         610-882-1820
         Investorinfo@orasure.com
         www.orasure.com

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