Theravance Reports Fourth Quarter and Full Year 2005 Financial Results
SOUTH SAN FRANCISCO, CA -- 02/09/2006 -- Theravance, Inc. (NASDAQ: THRX)
reported today its financial results for the fourth quarter and year ended
December 31, 2005. The net loss for the fourth quarter of 2005 was $42.2
million compared to $29.2 million during the same period of 2004, an
increase of $13.0 million. The increase was primarily due to higher
research and development costs associated with telavancin Phase 3 clinical
programs.
Research and development spending for the fourth quarter of 2005 increased
to $41.0 million compared to $27.3 million for the same period of 2004.
This increase was primarily driven by higher external research and
development costs associated with Phase 3 telavancin clinical programs and
Phase 1 clinical studies for the gastrointestinal (GI) motility dysfunction
program. Total external research and development costs were $26.2 million
in the fourth quarter of 2005 compared to $13.2 million in the same period
of 2004. General and administrative costs for the fourth quarter of 2005
increased to $4.6 million compared to $3.9 million in the same period of
2004 primarily driven by higher auditing and consulting costs related to
Sarbanes-Oxley compliance, increases in telavancin prelaunch costs, and
higher employee related expenses.
Revenue was $3.4 million in the fourth quarter of 2005 compared to $2.7
million in the same period of 2004. The increase was primarily due to
amortization of additional upfront and milestone payments received from the
Company's partnerships with GlaxoSmithKline (GSK) and Astellas Pharma Inc.
(Astellas). All payments received to date under these agreements are being
amortized over the relevant performance periods rather than recognized when
received.
Cash, cash equivalents, and short-term investments totaled $200.0 million
at the end of the fourth quarter 2005, an increase of $27.7 million during
the fourth quarter 2005 and a decrease of $57.1 million since December 31,
2004. This increase during the fourth quarter of 2005 includes a $65.0
million payment received in December in connection with the Company's
partnership with Astellas.
Year to Date
For the full year 2005, the net loss increased to $143.2 million compared
to $102.7 million in 2004. The increase was primarily due to higher
research and development costs associated with telavancin Phase 3 clinical
programs.
Research and development spending for the year 2005 was $134.7 million,
compared to $87.0 million in 2004. This increase was primarily driven by
external research and development costs associated with Phase 3 telavancin
clinical studies and Phase 1 clinical studies for the GI motility
dysfunction program and the overactive bladder program, which was
discontinued in October 2005. Total external research and development
spending was $78.7 million for the year 2005, up $43.6 million compared to
2004. General and administrative costs were $21.3 million compared to $19.8
million in 2004. Revenue for the year 2005 was $12.1 million compared to
$8.9 million in 2004, an increase of $3.2 million. The increase was
primarily due to amortization of additional upfront and milestone payments
received from GSK and Astellas.
Recent News
On February 7, 2006, the Company closed an underwritten public offering of
5.2 million shares of common stock at a price per share of $28.50, raising
net proceeds of approximately $139.8 million. The 5.2 million shares
issued in the offering include 600,000 shares issued pursuant to the
underwriters' exercise of their over-allotment option. A shelf registration
statement relating to these shares of common stock became effective upon
filing with the Securities and Exchange Commission (SEC) on January 30,
2006. The final prospectus, dated February 1, 2006 and available for
viewing on the SEC's website at www.sec.gov, contains current information
regarding the status of our programs.
Conference Call and Webcast Information
As previously announced, the Company has scheduled a conference call to
discuss this announcement beginning at 5:00 p.m. Eastern Standard Time
today. To participate in the live call by telephone, please dial
800-810-0924 from the U.S., or 913-981-4900 for international callers.
Those interested in listening to the conference call live via the internet
may do so by visiting the Company's web site at www.theravance.com. To
listen to the live call, please go to the web site 15 minutes prior to its
start to register, download, and install any necessary audio software.
A replay of the conference call will be available on the company's web site
for 30 days through March 11, 2006. An audio replay will also be available
through 11:59 p.m. Eastern Standard Time on February 23, 2006 by dialing
888-203-1112 from the U.S., or 719-457-0820 for international callers, and
entering confirmation code 4105801.
About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally
discovered product candidates. Theravance is focused on the discovery,
development and commercialization of small molecule medicines across a
number of therapeutic areas including respiratory disease, bacterial
infections and gastrointestinal disorders. Of the five programs in
development, two are in late stage -- its telavancin program focusing on
treating serious Gram-positive bacterial infections with Astellas Pharma
Inc., and the Beyond Advair collaboration with GlaxoSmithKline. By
leveraging its proprietary insight of multivalency to drug discovery
focused on validated targets, Theravance is pursuing a next generation drug
discovery strategy designed to discover superior medicines in large
markets. For more information, please visit the company's web site at
www.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE®
are registered trademarks of Theravance, Inc. This press release contains
and the conference call will contain 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. Theravance 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 Theravance'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 management of Theravance as of the date of this press
release and the conference call and are subject to risks, uncertainties,
changes in circumstances, assumptions and other factors that may cause the
actual results of Theravance 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 third parties to develop and commercialize products.
These and other risks are described in greater detail in Theravance's
filings with the Securities and Exchange Commission (SEC), including its
prospectus dated February 1, 2006 filed with the SEC pursuant to Rule
424(b)(5) of the Securities Act of 1933, as amended. Given these
uncertainties, you should not place undue reliance on these forward-looking
statements. Theravance assumes no obligation to update its forward-looking
statements.
THERAVANCE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended Year Ended
December 31, December 31,
---------------------- ----------------------
2005 2004 2005 2004
--------- --------- --------- ---------
(unaudited) (unaudited) (3)
Revenue (1) $ 3,378 $ 2,740 $ 12,054 $ 8,940
Operating
expenses:
Research and
development 41,023 27,302 134,677 86,996
General and
administrative 4,578 3,859 21,310 19,818
Stock-based
compensation 1,689 2,361 5,623 8,521
--------- --------- --------- ---------
Total operating
expenses 47,290 33,522 161,610 115,335
--------- --------- --------- ---------
Loss from
operations (43,912) (30,782) (149,556) (106,395)
Interest and
other income, net 1,816 1,802 6,969 4,564
Interest
expense (115) (191) (577) (823)
--------- --------- --------- ---------
Net loss $ (42,211) $ (29,171) $(143,164) $(102,654)
========= ========= ========= =========
Net loss
per share (2) $ (0.79) $ (0.56) $ (2.69) $ (3.08)
========= ========= ========= =========
Shares used
in computing
net loss
per share (2) 53,624 52,441 53,270 33,283
========= ========= ========= =========
Shares
outstanding
at the end
of the
period (2) 53,877 52,924 53,877 52,924
========= ========= ========= =========
(1) Revenue includes amounts from GSK, a related party, of $3,005 and
$11,681 for three months and year ended December 31, 2005,
respectively and $2,740 and $8,940 for the three months and year ended
December 31, 2004, respectively.
(2) Shares used in computing net loss per share excludes approximately
10.3 million and 9.8 million shares subject to repurchase and shares
issuable upon exercise of outstanding stock options and warrants as of
December 31, 2005 and 2004, respectively, as their effect would be
antidilutive.
(3) The condensed consolidated statements of operations amounts for the
year ended December 31, 2004 are derived from audited financial
statements.
THERAVANCE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
December 31, December 31,
2005 2004
--------- ---------
(unaudited) (2)
Assets
Cash, cash equivalents and short-term
investments $ 200,009 $ 257,141
Other current assets 4,893 7,327
Property and equipment, net 13,180 13,242
Other assets 6,753 8,312
--------- ---------
Total assets $ 224,835 $ 286,022
========= =========
Liabilities and stockholders' equity
Current liabilities, net of current
portion of deferred revenue (1) $ 31,179 $ 22,979
Deferred revenue (1) 128,245 67,298
Other long-term liabilities 5,827 5,378
Stockholders' equity 59,584 190,367
--------- ---------
Total liabilities and stockholders' equity $ 224,835 $ 286,022
========= =========
(1) Deferred revenue includes the current portion of $17.0 million and
$11.0 million as of December 31, 2005 and 2004, respectively. The net
decrease in total deferred revenue is a result of the amortization of
deferred revenue partially offset by additional upfront and milestone
payments that were received under the Companys "Beyond Advair"
collaboration and strategic alliance with GSK in March and June 2005,
respectively.
(2) The condensed consolidated balance sheet amounts at December 31, 2004
are derived from audited financial statements.