Theravance Reports Second Quarter 2006 Results
SOUTH SAN FRANCISCO, CA -- 07/27/2006 -- Theravance, Inc. (NASDAQ: THRX)
reported today its financial results for the second quarter ended June 30,
2006. The net loss for the second quarter of 2006 was $41.5 million
compared to $31.7 million during the same period of 2005, an increase of
$9.8 million. The higher loss was primarily due to increased research and
development costs associated with telavancin Phase 3 clinical programs and
additional 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)). Research and development costs
of $40.8 million during the second quarter 2006 were $7.9 million lower
than the quarter ended March 31, 2006, due to lower clinical trial
enrollment costs.
"I am pleased with the company's execution during the quarter," said Rick E
Winningham, Chief Executive Officer. "We recently completed enrollment in
our telavancin Phase 3 complicated skin and skin structure program and
expect to report top line data later in Q3. We now have two compounds in a
Phase 2b clinical program in our Beyond Advair Collaboration, with a third
compound progressing well in Phase 2. In addition, we continue to make
progress with our other programs."
Program Highlights
Bacterial Infections Programs:
Telavancin
We have completed enrollment in our Phase 3 studies for the treatment of
patients with serious Gram-positive complicated skin and skin structure
infections (cSSSI), including those due to resistant pathogens such as
methicillin-resistant Staphylococcus aureus (MRSA), and we received a
milestone payment of $25.0 million under our agreement with Astellas Pharma
Inc. (Astellas). Enrollment included over 1,800 patients, of which more
than one third had confirmed methicillin-resistant infections.
Our Phase 3 program for the treatment of resistant Gram-positive
hospital-acquired pneumonia continues to progress. Completion of
enrollment in this program will likely occur during the first half of 2007.
For the upcoming Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC), sixteen telavancin abstracts have been submitted and
accepted.
Heterodimer
We recently completed single-dose Phase 1 studies and have initiated
multiple-dose Phase 1 studies of our unique heterodimer antibiotic TD-1792.
This compound combines the antibacterial activities of a glycopeptide and a
beta-lactam in one molecule.
Respiratory Programs:
Beyond Advair
On June 12, 2006, the company announced that GlaxoSmithKline (GSK) enrolled
the first patient in the Beyond Advair Phase 2b clinical program with
compound 642444 ('444), an investigational long-acting beta2 agonist (LABA)
in patients with mild to moderate asthma. The collaboration now has two
compounds in this phase of development: '444, a GSK-discovered compound,
and 159797 ('797), a Theravance-discovered compound.
Long-Acting Muscarinic Antagonist (LAMA) and Bifunctional Muscarinic
Antagonist-Beta2 Agonist (MABA)
Our LAMA and MABA programs for the treatment of chronic obstructive pulmonary disease continue to progress.
Gastrointestinal (GI) Motility Dysfunction Program:
We have completed single- and multiple-dose Phase 1 studies of TD-5108 and
are currently evaluating the results.
Financial Results
Revenue:
Revenue was $4.8 million in the second quarter of 2006 compared to $2.9
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. All payments received to
date under these agreements are being amortized over the relevant
performance periods rather than recognized when received.
Research and Development:
Research and development spending for the second quarter of 2006 increased
to $40.8 million compared to $28.9 million for the same period of 2005 and
decreased by $7.9 million compared to $48.7 million in the first quarter of
2006. The year-over-year increase was primarily driven by higher external
research and development costs associated with our two Phase 3 programs for
telavancin and the impact of
SFAS 123(R). Total research and development
stock-based compensation expense for the three months ended June 30, 2006
was $3.3 million compared to $0.8 million for the same period in 2005.
Total external research and development costs were $22.9 million in the
second quarter of 2006 compared to $14.4 million in the same period of
2005.
General and Administrative:
General and administrative costs for the second quarter of 2006 increased
to $8.9 million compared to $7.2 million in the same period of 2005
primarily driven by the adoption of SFAS 123(R) and higher employee costs.
Total general and administrative stock-based compensation expense for the
second quarter of 2006 was $3.5 million compared to $0.6 million for the
same period last year.
Cash and Cash Equivalents:
Cash, cash equivalents and marketable securities totaled $293.5 million as
of June 30, 2006, a decrease of $5.3 million during the quarter. This
decrease was primarily due to cash usage of approximately $38.3 million
during the second quarter offset by the receipt of milestone payments of
$33.0 million, including $25.0 million from Astellas and $8.0 million from
GSK.
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 Daylight 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 August 26, 2006. An audio replay will also be
available through 11:59 p.m. Eastern Daylight Time on August 26, 2006 by
dialing 888-203-1112 from the U.S., or 719-457-0820 for international
callers, and entering confirmation code 6744312.
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, 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 Theravance's 10-Q filed with the Securities and
Exchange Commission (SEC) on May 8, 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 Six Months Ended
June 30, June 30,
-------------------- --------------------
2006 2005 2006 2005
--------- --------- --------- ---------
(unaudited) (unaudited)
Revenue (1) $ 4,837 $ 2,913 $ 9,133 $ 5,670
Operating expenses:
Research and development (2) 40,751 28,889 89,459 59,086
General and administrative (2)
8,899 7,215 16,173 12,851
--------- --------- --------- ---------
Total operating expenses 49,650 36,104 105,632 71,937
--------- --------- --------- ---------
Loss from operations (44,813) (33,191) (96,499) (66,267)
Interest and other income, net 3,474 1,619 6,359 3,437
Interest expense (136) (144) (287) (337)
--------- --------- --------- ---------
Net loss $ (41,475) $ (31,716) $ (90,427) $ (63,167)
========= ========= ========= =========
Net loss per share (3) $ (0.70) $ (0.60) $ (1.55) $ (1.19)
========= ========= ========= =========
Shares used in computing
net loss per share (3) 59,440 53,163 58,185 53,025
========= ========= ========= =========
(1) Revenue includes amounts from GSK, a related party, of $3.3 million and
$6.4 million for the three months and six months ended June 30, 2006,
respectively, and $2.9 million and $5.7 million for the three months
and six months ended June 30, 2005, respectively.
(2) Amounts include stock-based compensation expense for the three months
and six months ended June 30 as follows (in thousands):
Three Months Ended Six Months Ended
June 30, June 30,
----------------- -----------------
2006 2005 2006 2005
-------- -------- -------- --------
(unaudited) (unaudited)
Research and development $ 3,290 $ 839 $ 6,337 $ 1,681
General and administrative 3,465 595 5,431 1,161
-------- -------- -------- --------
Total stock-based compensation expense $ 6,755 $ 1,434 $ 11,768 $ 2,842
======== ======== ======== ========
(3) 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 and shares subject to repurchase as of June
30, 2006 and 2005, respectively, as their effect would be antidilutive.
THERAVANCE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
June 30, December 31,
2006 2005
------------ ------------
(unaudited) (2)
Assets
Cash, cash equivalents and marketable
securities $ 242,441 $ 161,925
Other current assets 5,066 4,893
Marketable securities - non-current 51,045 38,084
Property and equipment, net 13,413 13,180
Other assets 6,932 6,753
------------ ------------
Total assets $ 318,897 $ 224,835
============ ============
Liabilities and stockholders equity
Current liabilities, net of current portion of
deferred revenue (1) $ 32,595 $ 31,179
Deferred revenue (1) 154,112 128,245
Other long-term liabilities 6,583 5,827
Stockholders equity 125,607 59,584
------------ ------------
Total liabilities and stockholders equity $ 318,897 $ 224,835
============ ============
(1) Deferred revenue includes the current portion of $21.5 million and
$17.0 million as of June 30, 2006 and December 31, 2005, respectively.
The net increase in total deferred revenue is a result of additional
upfront and milestone payments that were earned under the company's
strategic alliance 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.