OraSure to Implement $18 Million Product Supply Co

BETHLEHEM, Pa., Nov. 29, 2016 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR ), a leader in point of care diagnostic tests and specimen collection devices, announced today that it will begin fulfilling a contract to supply a foreign government with $18 million of product, primarily to support a nationwide hepatitis C (HCV) testing and treatment program with the goal of eliminating HCV infection across the country by 2020.

The contract calls for the purchase of $16 million of OraQuick ^® HCV Rapid Antibody Tests and $2 million of OraQuick ^® Rapid HIV-1/2 Antibody Tests.  This represents the largest supply contract for OraQuick ^® rapid tests in the Company’s history.

“The international marketplace is becoming an increasingly important opportunity for our business and particularly the OraQuick ^® HCV test. This significant purchase is a testament to the high quality and versatility of our technology which is ideal for such broad scale applications,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “This is just one of a growing number of countries evaluating similar country-wide HCV elimination programs.” 

The contract provides for product deliveries over a 12-month period beginning in 2016 and continuing through late 2017.  The Company expects to recognize revenue over the next several quarters as follows: Q4 2016 - $1.4 million; Q1 2017 - $3.0 million; Q2 2017 - $4.8 million; Q3 2017 - $7.6 million; and Q4 2017 - $1.2 million.  Approximately 90 percent of these revenues are for the OraQuick HCV test with the balance being for the OraQuick HIV test. 

The contract also includes an option for 2017/2018 under which the government may make an additional purchase of up to 100 percent of the original quantities of product on the same terms and conditions as provided in the contract.

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of point of care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick ^® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. 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, commercial and industrial entities and consumers. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.

Important Information

This press release contains certain forward-looking statements. 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; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; 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, historic purchase levels or minimum purchase requirements for the Company’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues; ability to identify, complete, integrate and realize the full benefits of future acquisitions; impact of competitors, competing products and technology changes; impact of negative economic conditions, high unemployment levels 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 or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention (“CDC”) or other agencies; 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 the Company’s 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 meet financial covenants in credit agreements; ability to attract and 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, 2015, 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 mentioned above are made as of the date of this release and OraSure Technologies undertakes no duty to update those statements.

For more information on OraSure Technologies, please visit www.orasure.com .

Ronald H. Spair Chief Financial Officer 610-882-1820 Investorinfo@orasure.com Ron Ticho SVP, Corporate Communications 484-353-1575 media@orasure.com