OraSure to Implement $18 Million Product Supply Contract From Foreign Government for HCV Elimination Program
November 29 2016 - 6:00AM
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
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