Theravance Reports Fourth Quarter and Full Year 2006 Results
SOUTH SAN FRANCISCO, CA -- 02/08/2007 -- Theravance, Inc. (NASDAQ: THRX)
reported today its financial results for the fourth quarter and full year
ended December 31, 2006. Net loss for the fourth quarter and full year
2006 were $37.8 million and $166.0 million, respectively, compared with
$42.2 million and $143.2 million during the same periods of 2005. The
lower net loss during the fourth quarter 2006 was primarily driven by
decreased research and development costs associated with the completion of
the telavancin Phase 3 clinical program in complicated skin and skin
structure infections (cSSSI) partially offset by higher stock-based
compensation expense associated with the adoption of the Financial
Accounting Standards Board's Statement No. 123 (revised 2004), "Share-Based
Payment" (SFAS 123(R)).
"Theravance had a very successful 2006 as we continued to make significant
progress toward our goal of discovering, developing and commercializing
medicines," said Rick E Winningham, Chief Executive Officer. "During the
fourth quarter, we submitted our first NDA to the U.S. FDA for complicated
skin and skin structure infections caused by Gram-positive bacteria and we
initiated two Phase 2 programs: one with TD-1792, our potent,
next-generation heterodimer antibiotic and the other with TD-5108, the lead
compound in our GI motility dysfunction program. The year as a whole was
marked by substantial progress in our clinical programs, five of which are
in Phase 2 or later stages of development. We look forward to an exciting
year ahead, with a number of important events in 2007."
Program Highlights
Bacterial Infections Programs
Telavancin
In December, we submitted a new drug application (NDA) to the U.S. Food and
Drug Administration (FDA) for the treatment of cSSSI caused by
Gram-positive bacteria, including resistant pathogens such as
methicillin-resistant Staphylococcus aureus (MRSA).
Our Phase 3 program for the treatment of hospital-acquired pneumonia caused
by Gram-positive bacteria, including resistant pathogens such MRSA,
continues to progress, with enrollment likely to be completed during the
first half of 2007.
Heterodimer
We recently initiated a Phase 2 clinical program with TD-1792, our
investigational heterodimer antibiotic, for the treatment of cSSSI caused
by Gram-positive bacteria, including resistant pathogens such as MRSA. The
goal of this program is to develop a next-generation antibiotic that is
more efficacious than vancomycin, the current standard of care for the
treatment of serious infections caused by MRSA, and which has an improved
resistance profile relative to other available antibiotics.
Respiratory Programs
Beyond Advair
Our collaboration with GlaxoSmithKline (GSK) to develop and commercialize a
once-daily Long-Acting Beta2 Agonist (LABA) product candidate for the
treatment of asthma and chronic obstructive pulmonary disease (COPD)
continues to progress, with two compounds, GSK159797 and GSK642444,
expected to generate data from the ongoing Phase 2b program during the
first half of 2007.
Inhaled Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) Program
The lead compound in our MABA program, GSK961081, for the treatment of COPD
successfully completed single- and multiple-dose Phase 1 studies in healthy
subjects and was shown to be generally well tolerated, with evidence of 24
hour bronchodilation.
Inhaled Long Acting Muscarinic Antagonist (LAMA)
Our lead compound for the treatment of COPD continues to progress in
preclinical studies.
Gastrointestinal (GI) Motility Dysfunction Program
On October 7, 2006, we announced the initiation of a Phase 2 clinical
program in GI motility dysfunction with TD-5108, an investigational
compound for the treatment of chronic constipation. The program remains on
track, with data expected during the second half of 2007.
Financial Results
Revenue
Revenue was $4.9 million in the fourth quarter of 2006 compared with $3.4
million in the same period of 2005. This increase was primarily due to
higher amortization of upfront and milestone payments received from the
company's partnerships with GSK and Astellas. For the full year 2006,
revenue was $19.6 million, up from $12.1 million during the full year 2005.
All payments received to date under these agreements are being amortized
over the relevant performance periods rather than being recognized when
received.
Research and Development
Research and development spending for the fourth quarter of 2006 decreased
to $38.0 million compared with $41.7 million for the same period of 2005.
The year-over-year decrease was primarily driven by lower external research
and development costs associated with our telavancin Phase 3 program for
cSSSI which were partially offset by the impact of SFAS 123(R). For the
full year 2006, total research and development costs were $166.6 million,
an increase of $28.6 million compared with 2005. This increase was
primarily due to higher costs associated with our two Phase 3 telavancin
programs and higher stock-based compensation expenses related to SFAS
123(R). Total research and development stock-based compensation expenses
for the three months and twelve months ended December 31, 2006 were $3.3
million and $12.6 million, respectively, compared with $0.6 million and
$3.3 million for the same periods in 2005. Total external research and
development costs were $20.1 million in the fourth quarter of 2006 compared
to $26.2 million in the same period of 2005.
General and Administrative
General and administrative costs for the fourth quarter and full year of
2006 were $8.2 million and $32.2 million, respectively, compared with $5.6
million and $23.7 million for the same periods in 2005. This increase was
primarily driven by stock-based compensation expenses, IT consulting costs
related to the NDA filing, and higher employee costs. Total general and
administrative stock-based compensation expense for the fourth quarter and
full year of 2006 was $2.1 million and $9.2 million, respectively.
Cash and Cash Equivalents
Cash, cash equivalents and marketable securities totaled $235.6 million as
of December 31, 2006, a decrease of $31.5 million during the fourth
quarter.
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
800-811-0667 from the U.S., or 913-981-4901 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 10, 2007. An audio replay will be available
through 11:59 p.m. Eastern Standard Time on February 22, 2007 by dialing
888-203-1112 from the U.S., or 719-457-0820 for international callers, and
entering confirmation code 5395479.
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 motility dysfunction. 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 and
regulatory review, 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, 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 under the heading
"Risk Factors" contained in Item 1A of Theravance's Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission (SEC) on
November 6, 2006 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. 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 Twelve Months Ended
December 31, December 31,
---------------------- ----------------------
2006 2005 2006 2005
---------- ---------- ---------- ----------
(unaudited) (unaudited) (3)
Revenue (1) $ 4,930 $ 3,378 $ 19,587 $ 12,054
Operating expenses:
Research and
development(2) 38,002 41,646 166,564 137,936
General and
administrative (2) 8,152 5,644 32,193 23,674
---------- ---------- ---------- ----------
Total operating expenses 46,154 47,290 198,757 161,610
---------- ---------- ---------- ----------
Loss from operations (41,224) (43,912) (179,170) (149,556)
Interest and other income,
net 3,415 1,816 13,649 6,969
Interest expense (28) (115) (523) (577)
---------- ---------- ---------- ----------
Net loss $ (37,837) $ (42,211) $ (166,044) $ (143,164)
========== ========== ========== ==========
Net loss per share (4) $ (0.63) $ (0.79) $ (2.81) $ (2.69)
========== ========== ========== ==========
Shares used in
computing net loss per
share (4) 59,932 53,264 59,013 53,270
========== ========== ========== ==========
(1) Revenue includes amounts from GSK, a related party, of $2.8 million and
$12.6 million for the three months and twelve months ended December 31,
2006, respectively, and $3.0 million and $11.7 million for the three
months and twelve months ended December 31, 2005, respectively.
(2) Amounts include stock-based compensation expense for the three months
and twelve months ended December 31 as follows (in thousands):
Three Months Twelve Months
Ended Ended
December 31, December 31,
----------------- -----------------
2006 2005 2006 2005
-------- -------- -------- --------
(unaudited) (unaudited) (3)
Research and development $ 3,257 $ 623 $ 12,635 $ 3,259
General and administrative 2,090 1,066 9,196 2,364
-------- -------- -------- --------
Total stock-based compensation expense $ 5,347 $ 1,689 $ 21,831 $ 5,623
======== ======== ======== ========
(3) The condensed consolidated statement of operations amounts for the year
ended December 31, 2005 are derived from audited financial statements.
(4) Shares used in computing net loss per share exclude approximately 10.6
million and 10.3 million shares issuable upon exercise of outstanding
stock options and warrants, restricted shares, and shares subject to
repurchase as of December 31, 2006 and 2005, respectively, as their
effect would be antidilutive.
THERAVANCE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
December 31, December 31,
2006 2005
------------ ------------
(unaudited) (2)
Assets
Cash, cash equivalents and marketable
securities $ 201,080 $ 161,925
Other current assets 4,969 4,893
Marketable securities non-current 34,490 38,084
Property and equipment, net 15,101 13,180
Other assets 6,784 6,753
------------ ------------
Total assets $ 262,424 $ 224,835
============ ============
Liabilities and stockholders equity
Current liabilities, net of current portion of
deferred revenue (1) $ 40,336 $ 31,179
Deferred revenue (1) 153,656 128,245
Other long-term liabilities 5,122 5,827
Stockholders equity 63,310 59,584
------------ ------------
Total liabilities and stockholders equity $ 262,424 $ 224,835
============ ============
(1) Deferred revenue includes the current portion of $19.3 million and
$17.0 million as of December 31, 2006 and December 31, 2005,
respectively. The net increase in total deferred revenue is the result
of additional upfront and milestone payments that were earned under the
Companys strategic alliance and Beyond Advair collaboration with GSK
and its collaboration with Astellas partially offset by the
amortization of deferred revenue.
(2) The condensed consolidated balance sheet amounts at December 31, 2005
are derived from audited financial statements.