OraSure Technologies Provides Update on Clinical Development Programs and OraQuick Manufacturing
OraQuick® HCV Test
During the fourth quarter of 2008, the Company filed a premarket
approval application (“PMA”) with the
Since filing its PMA, the Company has been in frequent communications
with the
When the agency later raised concerns during the PMA review regarding
potential interpretation bias, the Company reasonably expected to be
able to address these concerns without material impact to the clinical
program because the Company had executed the clinical program as
designed. However, the
Although the Company believes the clinical data originally submitted to
the
The Company also plans to submit its application for CE mark for the
OraQuick® HCV test shortly. A CE mark is required in order to
sell the product in
The Company expects to record a non-cash impairment charge of
OraQuick® HIV OTC Test
In
The
The Company will meet with the
OraQuick ADVANCE® HIV Manufacturing
The Company recently has been experiencing an intermittent difficulty in manufacturing a component required for its OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test that meets the Company’s internal quality requirements. This issue initially resulted in lower production yields, but the Company was able to manufacture sufficient product to meet existing customer demand. More recently, however, the Company has experienced additional difficulty in manufacturing this component. A multi-functional team has been working aggressively with the assistance of outside consultants to resolve this manufacturing issue. Because this issue has not yet been satisfactorily resolved, inventory levels have been reduced and the Company has been allocating available product among its customers. In addition, until this issue is satisfactorily resolved, the Company will be assisting customers in meeting their HIV testing needs.
The Company’s priority has been and continues to be to provide the highest quality product to its customers in compliance with all applicable legal and regulatory requirements. Only OraQuick ADVANCE® devices that meet the Company’s stringent quality standards have been and will be released into the field.
If the Company is unable to resume full-scale production of its OraQuick® HIV test this week, its revenues for the second quarter of 2009 will be negatively impacted. In addition, in view of the foregoing, the Company expects gross margin for the second quarter to be negatively impacted due primarily to higher unabsorbed production costs and scrap expenses.
About
Important Information
This press release contains certain forward-looking statements,
including with respect to revenues, expenses, products, clinical testing
and regulatory filings. Actual results could be significantly different.
Factors that could affect results include the 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; changes
in relationships, including disputes or disagreements, with strategic
partners 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 and success of direct sales efforts; inventory levels at
distributors and other customers; impact of competitors, competing
products and technology changes; 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 and extended shelf life; continued bulk purchases by
customers, including governmental agencies, and the ability to fully
deploy those purchases in a timely manner; 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 product components; availability of related
products produced by third parties or products required for use of our
products; 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; history of losses and ability to achieve sustained
profitability and ability to utilize net operating loss carryforwards 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 changes in international funding sources; loss or impairment
of sources of capital; ability to meet financial covenants in agreements
with financial institutions; ability to retain qualified personnel;
exposure to patent infringement, 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; ability to identify,
complete and realize the full benefits of potential acquisitions; and
general political, business and economic conditions. These and other
factors are discussed more fully in the
Source:
OraSure Technologies
Ronald H. Spair
Chief Financial
Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com