Theravance Reports Third Quarter 2010 Financial Results
SOUTH SAN FRANCISCO, CA -- (Marketwire - October 21, 2010) - Theravance, Inc. (NASDAQ: THRX)
reported today its financial results for the quarter ended September 30,
2010. Revenue for the third quarter of 2010 was $5.3 million. Net loss for
the third quarter of 2010 was $21.2 million or $0.29 per share. Cash, cash
equivalents and marketable securities totaled $192.5 million as of
September 30, 2010.
"We have made significant progress in the third quarter," said Rick E
Winningham, Chief Executive Officer. "The RELOVAIR™ Phase 3 programs in
COPD and asthma are progressing well and have now enrolled over 8,000
patients. Last month, preclinical and Phase 2a and 2b clinical data from
the RELOVAIR™ programs were presented by our partner, GSK, at the
European Respiratory Society Annual Congress in Barcelona, Spain.
Importantly, earlier today, we announced positive proof-of-concept results
from a Phase 2 clinical study with TD-1211, our internally discovered
peripherally selective mu opioid receptor antagonist, in patients with
opioid-induced constipation."
Program Highlights
RELOVAIR™ Programs
The RELOVAIR™ Phase 3 programs in chronic obstructive pulmonary disease
(COPD) and asthma are progressing and enrollment in the studies is largely
in line with expectations. RELOVAIR™ is an investigational medicine
that combines fluticasone furoate (an inhaled corticosteroid or ICS) and
vilanterol trifenatate (a newly developed long-acting beta agonist or LABA)
in a once-daily treatment for patients with COPD or asthma.
The Phase 3 asthma program consists of eight studies to determine the
safety and efficacy of RELOVAIR™ in asthma patients who remain
uncontrolled on current treatment. These studies include an exacerbation
study, a 12-month safety study (which also supports the COPD program), a
12-week low-dose combination efficacy study, a 24-week high-dose
combination efficacy study, a 24-week head-to-head study of RELOVAIR™
versus Advair/Seretide, a 24-week study of fluticasone furoate versus
fluticasone propionate, a 12-week study of vilanterol trifenatate versus
salmeterol, and a hypothalamic-pituitary-adrenal (HPA) axis study.
The Phase 3 program in COPD consists of five studies, including two
12-month exacerbation studies, two 6-month efficacy and safety studies, and
a detailed lung function profile study. Both the Phase 3 programs in COPD
and asthma will enroll approximately 11,000 patients in total.
In September 2010, GlaxoSmithKline (GSK) presented preclinical and clinical
abstracts for RELOVAIR™ and its individual components in COPD and asthma
at the European Respiratory Society Annual Congress in Barcelona Spain.
Eight of these abstracts highlighted Phase 2a and Phase 2b results of
RELOVAIR™ and its components.
Peripheral Mu Opioid Receptor Antagonist (PUMA) -- TD-1211
Earlier today, positive topline results from a Phase 1 multiple-ascending
dose study and proof-of-concept Phase 2 clinical study evaluating TD-1211
in patients with opioid-induced constipation (OIC) were announced. TD-1211
is a once-a-day, orally-administered, peripherally selective, multivalent
inhibitor of the mu opioid receptor designed to alleviate gastrointestinal
side effects of opioid therapy without affecting analgesia. The positive
Phase 1 and Phase 2 clinical results demonstrate proof-of-concept and
support further development of
TD-1211 for the treatment of patients with opioid-induced constipation.
Financial Results
Revenue
Revenue was $5.3 million for the third quarter of 2010 compared with $5.5
million for the same period in 2009. During the third quarter, $0.4
million of royalty revenue was earned from VIBATIV™ net sales of $2.3
million.
Research and Development
Research and development expense for the third quarter of 2010 decreased to
$18.5 million compared with $19.5 million for the same period in 2009. The
decrease was primarily due to lower external costs from our new drug
discovery programs and facilities costs. Total external research and
development expense was $3.5 million during the third quarter of 2010
compared with $3.8 million for the same period in 2009. Total research and
development stock-based compensation expense for the third quarter of 2010
was $2.6 million compared with $2.9 million for the same period in 2009.
General and Administrative
General and administrative expense for the third quarter of 2010 decreased
to $6.6 million from $7.1 million for the same period in 2009. Total
general and administrative stock-based compensation expense for the third
quarter of 2010 was $1.9 million compared with $2.1 million for the same
period in 2009.
Cash and Cash Equivalents
Cash, cash equivalents and marketable securities totaled $192.5 million as
of September 30, 2010, a decrease of $18.2 million during the third
quarter. The decrease was primarily due to cash used in operations.
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 (877)
837-3908 from the U.S., or (973) 890-8166 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 November 20, 2010. An audio replay will also be
available through 11:59 p.m. Eastern Daylight Time on October 28, 2010 by
dialing (800) 642-1687 from the U.S., or (706) 645-9291 for international
callers, and entering confirmation code 13531113.
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. The Company's key
programs include: VIBATIV™ (telavancin) with Astellas Pharma Inc. and
the RELOVAIR™ program and Bifunctional Muscarinic Antagonist-Beta2
Agonist (MABA) program with GlaxoSmithKline plc. By leveraging its
proprietary insight of multivalency toward drug discovery, Theravance is
pursuing a best-in-class strategy designed to discover superior medicines
in areas of significant unmet medical need. 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.
VIBATIV is a trademark of Astellas Pharma Inc.
RELOVAIR is a trademark of Glaxo Group Limited. Mark is intended for U.S.
and subject to FDA approval.
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
and timing of clinical studies and product commercialization, statements
regarding the potential benefits of drug candidates, statements concerning
the timing of seeking regulatory approval of our product candidates,
statements concerning enabling capabilities of Theravance's approach to
drug discovery and its proprietary insights, and statements regarding
expectations for product candidates through development and
commercialization and projections of revenue, expenses 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 studies, the potential that results of
clinical or preclinical studies indicate product candidates are unsafe or
ineffective, our dependence on third parties in the conduct of our clinical
studies, delays or failure to achieve regulatory approvals for product
candidates, risks of relying on third-party manufacturers for the supply of
our product candidates 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
Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on August 4, 2010 and the risks discussed in our other
period filings with 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 Nine Months Ended
September 30, September 30,
-------------------- --------------------
2010 2009 2010 2009
-------------------- --------------------
(unaudited) (unaudited)
Revenue $ 5,302 $ 5,515 $ 17,281 $ 20,552
Operating expenses:
Research and development (1) 18,537 19,541 57,594 59,118
General and administrative (1) 6,610 7,061 20,077 20,909
Restructuring charges - (6) - 1,307
--------- --------- --------- ---------
Total operating expenses 25,147 26,596 77,671 81,334
--------- --------- --------- ---------
Loss from operations (19,845) (21,081) (60,390) (60,782)
Interest and other income 136 413 364 2,232
Interest expense (1,513) (1,515) (4,537) (4,542)
--------- --------- --------- ---------
Net loss $ (21,222) $ (22,183) $ (64,563) $ (63,092)
========= ========= ========= =========
Basic and diluted net loss
per share $ (0.29) $ (0.35) $ (0.91) $ (1.00)
========= ========= ========= =========
Shares used in computing basic
and diluted net loss per share 73,726 63,236 70,675 62,792
========= ========= ========= =========
(1) Amounts include stock-based compensation expense for the three months
and nine months ended September 30 as follows (in thousands):
Three Months Ended Nine Months Ended
September 30, September 30,
-------------------- --------------------
2010 2009 2010 2009
-------------------- --------------------
(unaudited) (unaudited)
Research and development $ 2,564 $ 2,913 $ 7,709 $ 8,975
General and administrative 1,933 2,083 6,607 6,408
--------- --------- --------- ---------
Total stock-based compensation
expense $ 4,497 $ 4,996 $ 14,316 $ 15,383
========= ========= ========= =========
THERAVANCE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
September 30, December 31,
2010 2009
------------- -------------
(unaudited) (2)
------------- -------------
Assets
Cash, cash equivalents and marketable
securities $ 192,468 $ 155,390
Other current assets 5,019 6,652
Property and equipment, net 10,253 12,927
Other assets 4,840 6,424
------------- -------------
Total assets $ 212,580 $ 181,393
============= =============
Liabilities and stockholders' net
capital deficiency
Current liabilities (1) $ 36,381 $ 38,946
Deferred revenue 142,246 157,426
Convertible subordinated notes 172,500 172,500
Other long-term liabilities 2,597 1,515
Stockholders' net capital deficiency (141,144) (188,994)
------------- -------------
Total liabilities and stockholders'
net capital deficiency $ 212,580 $ 181,393
============= =============
(1) Amounts include current portion of deferred revenue of $22.8 million
and $23.7 million as of September 30, 2010 and December 31, 2009,
respectively.
(2) The condensed consolidated balance sheet amounts at December 31, 2009
are derived from audited financial statements.