SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): June 17, 2002
ORASURE TECHNOLOGIES, INC.
----------------------------
(Exact name of issuer as specified in charter)
DELAWARE 1-10492 36-4370966
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation or file Identification
Organization) number) Number)
150 Webster Street
Bethlehem, Pennsylvania 18015
(Address of principal executive offices)
(610) 882-1820
(Registrant's telephone number, including area code)
Item 5 - Other Events.
OraSure Technologies, Inc. (the "Company" or "OraSure") and Abbott Laboratories
("Abbott") jointly issued a press release on June 17, 2002, announcing
agreements for the co-exclusive distribution of the Company's OraQuick(R) rapid
test for the detection of antibodies to the Human Immunodeficiency Virus Type 1
("HIV-1") and for a non-exclusive sublicense of certain lateral-flow patents for
which Abbott is the exclusive licensor. A copy of the press release is attached
to this Report as Exhibit 99.
OraQuick(R) is a rapid, point-of-care test designed to detect antibodies to
HIV-1 within 20 minutes, and is the only rapid device in the world designed to
use oral fluid and whole blood samples. In June 2001, OraSure submitted an
application with the U.S. Food and Drug Administration ("FDA") for pre-market
approval of the OraQuick(R) device to test finger-stick whole blood specimens
for HIV-1. On May 11, 2002, OraSure received notification from the FDA that its
application was approvable, subject to OraSure meeting certain conditions.
OraSure intends to file an application for use of the device with oral fluid
specimens later in 2002.
Under the terms of the distribution agreement, Abbott was appointed as
co-exclusive distributor of the OraQuick(R) HIV-1 device in the United States,
and is expected to focus primarily on the hospital and physician's office
laboratory markets. The agreement also permits OraSure to sell OraQuick(R)
directly in the United States, and OraSure expects to sell primarily in the
public health and criminal justice markets in which it already has a direct
sales force to sell its products.
The distribution agreement contains certain minimum purchase commitments by
Abbott. Pursuant to these commitments, the Company expects to receive product
revenues of up to approximately $4 million through the end of 2003. These
expected revenues and the timing of their receipt are subject to the Company's
receipt of final FDA approval of the OraQuick(R) test during the third quarter
of 2002 and market acceptance of this product in the United States.
The foregoing contains certain forward-looking statements with respect to
revenues, products and markets. Actual results could be significantly different.
Factors that could affect results include the ability to market products; impact
of competitors, competing products and technology changes; ability to develop,
commercialize and market new products; market acceptance of oral fluid testing
products and other products; ability to fund research and development and other
projects and operations; ability to obtain and timing of obtaining necessary
regulatory approvals; ability to develop product distribution channels;
uncertainty relating to patent protection and potential patent infringement
claims; ability to enter into international manufacturing agreements; loss or
impairment of sources of capital; exposure to product liability and other types
of litigation; changes in international, federal or state laws and regulations;
changes in relationships with strategic partners and reliance on strategic
partners for the performance of critical activities under collaborative
arrangements; changes in accounting practices or interpretation of accounting
requirements; customer inventory practices and consolidations; equipment
failures and ability to obtain needed
raw materials and components; the impact of terrorism and civil unrest; and
general business, political and economic conditions. These and other factors are
discussed more fully in the Company's Securities and Exchange Commission
filings, including its registration statements, its Annual Report on Form 10-K
for the year ended December 31, 2001, and most recent Quarterly Report on Form
10-Q. Although forward-looking statements help to provide complete 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 Report and the Company undertakes no duty to update these
statements.
Item 7 - Financial Statements and Exhibits.
(c) Exhibits.
Exhibits are listed on the attached exhibit index following the signature
page of this Report.
Signatures
Pursuant to the requirements of the Securities and Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned, hereunto duly authorized.
OraSure Technologies, Inc.
Date: June 17, 2002 By: /s/ Jack E. Jerrett
------------------------------------
Jack E. Jerrett
Vice President, General Counsel
and Secretary
EXHIBIT INDEX
Exhibit
-------
99 Press Release issued June 17, 2002 by OraSure Technologies, Inc.
and Abbott Laboratories announcing distribution agreement for the
OraQuick(R) rapid HIV-1 test and sublicense of certain lateral
flow technology.