UNITED STATES
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): October 5, 2005
Gen-Probe Incorporated
(Exact Name of Registrant as Specified in Charter)
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Delaware
(State or Other Jurisdiction of
Incorporation)
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001-31279
(Commission
File Number)
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33-0044608
(I.R.S. Employer
Identification No.) |
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10210 Genetic Center Drive
San Diego, CA
(Address of Principal Executive Offices)
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92121
(Zip Code) |
(858) 410-8000
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
TABLE OF CONTENTS
Item 8.01. Other Events.
On October 5, 2005, Gen-Probe Incorporated (“Gen-Probe”) issued a news release providing an
update on the regulatory status of its investigational blood screening products based on recent
communications with the U.S. Food and Drug Administration (“FDA”).
The FDA notified Gen-Probe that it considers the
PROCLEIX® TIGRIS® system “not substantially equivalent” to the PROCLEIX
enhanced semi-automated system (“eSAS”) for screening donated human blood with the PROCLEIX
ULTRIOTM assay. The FDA made this determination in response to Gen-Probe’s 510(k)
application for the TIGRIS system. Gen-Probe has discussed the determination with the FDA and is
scheduling a series of meetings to resolve the outstanding issues.
Gen-Probe previously received 510(k) marketing clearance for the eSAS system used to screen
donated human blood using the ULTRIO assay. Gen-Probe also continues to expect approval of
its Biologics License Application for the ULTRIO assay this year.
This approval, if
granted, would enable U.S. customers to run the ULTRIO assay on the eSAS system on a commercial basis.
A copy of the news release is furnished with this Current Report as Exhibit 99.1.
Forward-Looking Statements
Any statements in this Current Report about Gen-Probe’s expectations, beliefs, plans,
objectives, assumptions or future events or performance are not historical facts and are
forward-looking statements. These statements are often, but not always, made through the use of
words or phrases such as “believe,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “plan,”
and “would.” For example, statements concerning Gen-Probe’s financial condition, possible or
expected future results of operations, growth opportunities, and plans and objectives of management
are all forward-looking statements. They involve known and unknown risks, uncertainties and
assumptions that may cause actual results, levels of activity, performance or achievements to
differ materially from those expressed or implied by any forward-looking statement. Some of the
risks, uncertainties and assumptions that could cause actual results to differ materially from
estimates or projections in the forward-looking statement include, but are not limited to: (i) the
risk that new products, including the PROCLEIX ULTRIO and PROCLEIX West Nile virus assays and the
PROCLEIX TIGRIS system, will not be cleared for marketing in the timeframes we expect, if at all,
(ii) the risk that we may not earn or receive milestone payments from our collaborators, including
Chiron (iii) the possibility that the market for the sale of our new products, such as our ULTRIO
and West Nile virus assays and the TIGRIS system, may not develop as expected, (iv) we may not be
able to compete effectively, (v) we may not be able to maintain our current corporate
collaborations and enter into new corporate collaborations or customer contracts, and (vi) we are
dependent on Chiron and other third parties for the distribution of some of our products. For
additional information about risks and uncertainties Gen-Probe faces and a discussion of
Gen-Probe’s financial statements, see documents filed with the SEC, including our Quarterly Report
on Form 10-Q for the quarter ended June 30, 2005 and all periodic filings made with the SEC.
Gen-Probe assumes no obligation and expressly disclaims any duty to update any forward-looking
statement to reflect events or circumstances after the date of this current report or to reflect
the occurrence of subsequent events.
Item 9.01. Financial Statements and Exhibits.
(c) The following exhibit is furnished with this Current Report:
99.1 News release dated October 5, 2005.(1)
(1) This Exhibit is being “furnished” by the Registrant and shall not be deemed “filed”
by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, or deemed to
be incorporated by reference into any filing under the Securities Act of 1933 or the Securities
Exchange Act of 1934.