OraSure Technologies and AbbVie Agree to an Early Termination of HCV Co-Promotion Agreement
July 01 2016 - 6:00AM
OraSure Technologies (NASDAQ:OSUR), a market leader in point of
care diagnostics, announced today that OraSure Technologies and
AbbVie have mutually agreed to an early termination of their Master
Program Services and Co-Promotion Agreement under which the
companies have been co-promoting OraSure’s OraQuick® HCV Rapid
Antibody Test in the United States. The agreement was originally
scheduled to continue through December 31, 2019 and will now end on
December 31, 2016.
Under the agreement, which was signed in June
2014, OraSure granted exclusive rights to AbbVie to co-promote the
OraQuick® HCV test in certain U.S. markets and provided certain
additional services in support of HCV testing in exchange for up to
$75 million from AbbVie in exclusivity payments over the term of
the agreement.
Following the termination of the agreement,
AbbVie will be relieved of its co-promotion obligations, including
its obligation to detail the OraQuick® HCV Rapid Test into
physician offices, and will have no further financial obligations
to OraSure. OraSure will no longer be obligated to compensate
AbbVie for product detailing activities and will be free to pursue
arrangements with other pharmaceutical companies to market and
promote its OraQuick® HCV Rapid Antibody Test in the U.S.
As previously disclosed, the Company has been
ratably recognizing the $75 million in aggregate exclusivity
payments contemplated by the agreement over the original five and
one-half year term. As a result of the shortened term, only a
portion of the $75 million will be received by OraSure and an
additional $5.4 million in exclusivity payments will be ratably
recognized as revenue over the remainder of 2016.
“Demand for our OraQuick® HCV Rapid Test is
growing,” said Douglas A. Michels, President and Chief Executive
Officer of OraSure Technologies. “With newly available HCV
therapeutics people can be cured of the disease over a relatively
short period of time with minimal side effects. In addition, both
government and non-government agencies are increasing efforts to
identify new HCV patients. We believe these factors will continue
to positively impact sales of our test.”
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 in 20 minutes, using
finger stick or venipuncture blood.
Conference Call
The Company will host a conference call and
audio webcast today 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 on the early termination of the OraSure/AbbVie
co-promotion agreement and on certain potential business
opportunities that could positively impact the Company’s future
growth. There will also be 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 #42635222 or go to
OraSure Technologies' web site at www.orasure.com and click on
the Investor Relations page. Please click on the webcast link and
follow the prompts for registration and access ten (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 July 8, 2016, by dialing (855) 859-2056 (Domestic) or (404)
537-3406 (International) and entering the Conference ID
42635222.
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.
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; 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 our 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, including changes in CDC or
other testing guidelines, algorithms or other recommendations;
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 OraSure’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 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 are made as of the date of this press
release and OraSure Technologies undertakes no duty to update these
statements.
Company Contact:
Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
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