The
information contained in this Item 7.01 and in the accompanying exhibit
shall not be deemed filed for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by
reference in any filing under the Exchange Act or the Securities Act of
1933, as
amended, except as shall be expressly set forth by specific reference in
such
filing.
On
January 11, 2006, Rick E Winningham and Michael Aguiar, the Chief Executive
Officer and the Chief Financial Officer, respectively, of Theravance, Inc.
(the
“Company”), held a conference call regarding the Company’s January 10, 2006
press release that provided updated guidance relating to the Company’s LABA
collaboration with GlaxoSmithKline. A copy of the transcript of the conference
call is attached hereto as Exhibit 99.1 and is incorporated herein by
reference.
In
addition, Mr. Winningham made a presentation on January 11, 2006 at the
24th
Annual JP Morgan Healthcare Conference during which he discussed the Company’s
significant milestones expected in 2006, as follows:
|
Complete
Phase 3 complicated skin and skin structure infection (cSSSI)
enrollment
|
1st
half of 2006
|
|
Initiate
Beyond Advair (159797) Phase 2b
|
1st
half of 2006
|
|
File
an NDA for Csssi
|
2nd
half of 2006
|
|
Complete
Phase 3 hospital acquired pneumonia (HAP) enrollment
|
2nd
half of 2006
|
Copies
of
the slides shown at this presentation are available for viewing at the
“Investor
Relations” section of our website located at http://ir.theravance.com/medialist.cfm,
although we reserve the right to discontinue that availability at any
time.
This
report contains certain "forward-looking" statements as that term is defined
in
the Private Securities Litigation Reform Act of 1995 regarding, among other
things, statements relating to goals, plans, objectives and future events.
The
Company intends such forward-looking statements to be covered by the safe
harbor
provisions for forward-looking statements contained in Section 21E of the
Exchange Act and the Private Securities Litigation Reform Act of 1995.
Examples
of such statements include statements relating to the goals, timing and
expected
results of clinical and preclinical studies, statements regarding the potential
benefits and mechanisms of action of drug candidates, the enabling capabilities
of the Company’s approach to drug discovery and its proprietary insights,
statements concerning expectations for product candidates through development
and commercialization and projections of revenue and other financial items.
These statements are based on the current estimates and assumptions of
the
Company’s management as of the date of this report and are naturally subject to
risks, uncertainties, changes in circumstances, assumptions and other factors
that may cause the actual results of the Company to be materially different
from
those reflected in its forward-looking statements. Important factors that
could
cause actual results to differ materially from those indicated by such
forward-looking statements include, among others, risks related to delays
or
difficulties in commencing or completing clinical and preclinical studies,
the
potential that results of clinical or preclinical studies indicate product
candidates are unsafe, ineffective, inferior or not superior, and delays
or
failure to achieve regulatory approvals, and risks of collaborating with
a third
party to develop and commercialize products. These and other risks are
described
in greater detail under the heading "Factors Affecting Results, Including
Risks
and Uncertainties" contained in Item 2, "Management's Discussion and Analysis
of
Financial Condition and Results of Operations" in the Company’s Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission (SEC) on
November
14, 2005 and the risks discussed in our other filings with the SEC. Given
these
uncertainties, you should not place undue reliance on these forward-looking
statements. The Company assumes no obligation to update its forward-looking
statements.