OraSure Technologies Announces New Co-Promotion Agreement for OraQuick(R) HCV Rapid Antibody Test
2014年6月11日 - 9:00PM
OraSure Technologies (Nasdaq:OSUR), a market leader in point of
care diagnostics, announced today that it has entered into a Master
Program Services and Co-Promotion Agreement with AbbVie under which
AbbVie and OraSure will co-promote the Company's OraQuick® HCV
Rapid Test in the United States. The product will be used to test
individuals at-risk for hepatitis C (HCV). OraSure will be
responsible for manufacturing and selling the product directly into
all markets.
Under the agreement, OraSure has granted exclusive promotion
rights to AbbVie for the OraQuick® HCV test in certain markets and
will provide certain additional services in support of HCV testing.
In exchange for the exclusive rights granted to AbbVie, OraSure
will receive up to $75 million in exclusivity payments over the
term of the agreement, which runs through December 31, 2019. In
addition, upon achievement of certain performance-based milestones,
OraSure will be eligible to receive additional payments annually
over the life of the agreement. Further information regarding the
agreement will be available in the Company's 8-K Report filed later
today with the SEC.
According to the Centers for Disease Control and Prevention
(CDC), HCV is the most common chronic blood-borne infection in the
United States, with approximately 5 million people infected. It is
estimated that one in 30 Baby Boomers (adults born between 1945 and
1965) have chronic hepatitis C and up to 75% of the people infected
with HCV are unaware of their infection. The CDC, the U.S.
Preventative Services Task Force (USPSTF), and the American
Association for the Study of Liver Diseases (AASLD) have all issued
guidance that recommends HCV testing for at-risk individuals
including all Baby Boomers.
"We believe it is critical that at-risk
individuals be tested for hepatitis C to prevent serious
consequences from untreated infection," said Douglas A. Michels,
President and Chief Executive Officer of OraSure Technologies.
"This new collaboration allows us to educate healthcare
professionals and the patients they treat about hepatitis C and
provide them with a very important rapid diagnostic tool."
The OraQuick® HCV test is the first and only FDA-approved and
CLIA-waived point of care test for detection of HCV infection in
at-risk individuals. The simple platform enables healthcare
providers to deliver a diagnosis based on lab-accurate test results
in 20 minutes, using fingerstick or venipuncture blood.
Updated Financial Guidance
As a result of the new co-promotion agreement announced today,
the Company has updated its financial guidance to reflect the
initial impact of this arrangement and is now projecting
consolidated net revenues ranging from $26.0 to $26.5 million and a
consolidated net loss of approximately $0.08 to $0.09 per share for
the second quarter of 2014.
Conference Call
The Company will host a conference call and audio webcast to
discuss the co-promotion agreement today beginning at 8:30 a.m.
Eastern Time (5:30 a.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 prepared remarks by management and a question and
answer session.
In order to listen to the conference call, please either dial
844-831-3030 (Domestic) or 315-625-6887 (International) and
reference Conference ID #59796252 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 June 18, 2014, by
dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and
entering the Conference ID #59796252.
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 innovative products include rapid tests for
the detection of antibodies to HIV and HCV at the point of care and
testing solutions tests for detecting various drugs of abuse. The
Company sells the OraQuick® In-Home HIV Test, the first and only
rapid HIV test approved by the U.S. Food and Drug Administration
for sale to the consumer over-the-counter market 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.
OraSure Technologies Forward-Looking
Statement
This press release contains certain forward-looking statements,
including with respect to expected revenues and product usage.
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 DNA Genotek
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 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; 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 the Company's 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 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, 2013, 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
Media Contact:
Jennifer Moritz
Zer0 to 5ive for OraSure Technologies
917-748-4006
jmoritz@0to5.com
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