Theravance Reports Third Quarter 2008 Financial Results
SOUTH SAN FRANCISCO, CA -- 10/23/2008 -- Theravance, Inc. (NASDAQ: THRX)
reported today its financial results for the quarter ended September 30,
2008. Net loss for the third quarter of 2008 was $20.9 million, compared
with $32.4 million for the same period of 2007, a decrease of $11.5
million. Net loss per share was $0.34 for the third quarter of 2008
compared with a net loss per share of $0.53 for the third quarter of 2007.
"We made progress during the third quarter in our respiratory programs and
with the U.S. telavancin program," said Rick E Winningham, Chief Executive
Officer. "GSK has now completed enrollment in all five Phase 2b studies in
the Horizon program, enrolling approximately 3,000 patients in total. We
anticipate communicating the results from these studies late this year and
in early 2009. Last week, we announced that we believe the ATLAS site
inspection activities for telavancin have been successfully resolved. We
look forward to reviewing the telavancin cSSSI NDA at the upcoming FDA
Advisory Committee meeting in November. In Europe, Astellas and Theravance
recently made a decision following discussions with the CHMP to withdraw
the telavancin cSSTI application and Astellas currently intends to prepare
a new marketing authorization application, including data from the
hospital-acquired pneumonia Phase 3 studies."
Program Highlights
Respiratory Programs
Horizon
Enrollment in the Phase 2b asthma and chronic obstructive pulmonary disease
(COPD) studies of the lead long-acting beta2 agonist (LABA), GW642444
('444), is complete. We expect to report results for the Phase 2b asthma
study of '444 during the fourth quarter of 2008 and for the Phase 2b COPD
study of '444 in early 2009.
Enrollment is also complete for three Phase 2b studies in patients with
mild, moderate, and severe asthma with the lead inhaled corticosteroid
(ICS), GW685698 ('698). We expect to concurrently report results from all
three '698 Phase 2b studies in early 2009.
Inhaled Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) Program
We are formulating a plan with GlaxoSmithKline plc (GSK) for the further
development of GSK961081 ('081), the lead MABA compound for the treatment
of COPD. In July, we reported clinical results from a Phase 2 study with
'081 in COPD patients. In this study, '081 administered once daily to COPD
patients demonstrated 24-hour bronchodilation on hour 24 on day 14 which
was statistically significantly greater than placebo, and similar in
magnitude to a combination therapy active control of salmeterol dosed twice
daily plus tiotropium dosed once daily. '081 was generally well tolerated
throughout the 14-day study, and adverse events were generally mild or
moderate, with the most common adverse events being headache and dizziness.
We received a milestone payment of $10 million in July from GSK in
conjunction with the successful achievement of proof-of-concept in the
Phase 2 clinical study.
Inhaled Long-Acting Muscarinic Antagonist (LAMA) Program
We continue working with GSK to complete the return of the LAMA program
from GSK to Theravance. In July, we reported clinical results from a Phase
1 study of TD-4208, an investigational compound for the treatment of COPD
in the LAMA program. In that study, a single dose of TD-4208 administered
to healthy volunteers was generally well tolerated, with a similar
incidence of adverse events, all mild or moderate, to placebo. In addition,
TD-4208 demonstrated evidence of bronchodilation in volunteers sensitive to
muscarinic antagonists. We intend to explore partnerships with other
companies for the further development of TD-4208.
Bacterial Infections Programs
Telavancin
On October 14, 2008, we announced that the Anti-Infective Drugs Advisory
Committee of the U.S. Food and Drug Administration (FDA) will convene on
the morning of November 19, 2008 to review the New Drug Application (NDA)
for telavancin for the treatment of complicated skin and skin structure
infections (cSSSI) caused by Gram-positive bacteria, including resistant
pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).
Based upon discussions with the FDA, we believe the site inspection issues
in the ATLAS program have been successfully resolved. The FDA requested
that the efficacy data from three clinical sites that enrolled 73 of the
total 1,867 patients from the ATLAS studies be removed from the efficacy
analysis for Advisory Committee review. The removal of these data had no
impact on the previously reported conclusions of the studies.
We plan on submitting to the FDA a NDA for telavancin for the treatment of
hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria
including resistant pathogens such as MRSA either in the fourth quarter of
2008 or in early 2009.
Also, we recently announced that new telavancin data will be presented at
CHEST 2008, the annual meeting of the American College of Chest Physicians
(ACCP) in Philadelphia, PA on October 27, 2008 and at the 48th Annual
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
and the Infectious Diseases Society of America (IDSA) 46th Annual Meeting
to be held in Washington, D.C. from October 25-28, 2008. At CHEST, a
podium presentation titled, "Telavancin: A Novel Agent for
Ventilator-Associated Pneumonia Due to Staphylococcus aureus" and focusing
on subgroup data from the telavancin Phase 3 ATTAIN studies will be
presented by Dr. Andrew Shorr, M.D., M.P.H., Associate Director, Pulmonary
and Critical Care Medicine, Washington Hospital Center and Associate
Professor of Medicine, Georgetown University. At ICAAC/IDSA, telavancin
data will be featured in twenty-five posters or podium presentations.
Astellas Pharma Europe B.V., a European subsidiary of Astellas Pharma Inc.,
voluntarily withdrew the European Marketing Authorization Application (MAA)
for telavancin for the treatment of complicated skin and soft tissue
infections (cSSTI) on October 20, 2008. Astellas and Theravance have taken
this decision based on communications from the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMEA) that
the data provided are not sufficient to allow the Committee to conclude a
positive benefit-risk balance for telavancin for the sole indication of
cSSTI at this time. Astellas currently intends to prepare a new MAA with
expanded clinical trial data that was not available at the time of the
initial application, including data from the HAP Phase 3 studies.
Gastrointestinal (GI) Motility Dysfunction Program
We recently dosed the first subject in a Phase 1 drug-drug interaction
study with TD-5108, our lead compound in the program. We continue to
evaluate the potential of this compound in chronic idiopathic constipation,
constipation-predominant irritable bowel syndrome and other indications,
and we intend to explore partnerships with other companies for the further
development of TD-5108.
Financial Results
Revenue
Revenue was $6.0 million for the third quarter of 2008 compared with $5.7
million for the same period of 2007. This increase was due to higher
amortization of 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 being
recognized when received.
Research and Development
Research and development expense for the third quarter of 2008 decreased to
$20.1 million from $32.0 million for the same period of 2007. Total
external research and development expense for the third quarter of 2008 was
$5.0 million compared with $11.4 million for the same period in 2007. The
lower expenses in the third quarter of 2008 were primarily due to decreased
external clinical study costs associated with TD-5108, TD-1792, and
telavancin as well as lower employee related costs due to the reduction in
force announced in April 2008. Total research and development stock-based
compensation expense for the third quarter of 2008 was $2.9 million
compared with $3.5 million in same period of 2007.
General and Administrative
General and administrative expense for the third quarter of 2008 decreased
to $6.5 million from $8.5 million for the same period in 2007. The lower
expense in the third quarter of 2008 was primarily due to lower employee
and facilities related costs due to the reduction in force announced in
April 2008. Total general and administrative stock-based compensation
expense for the third quarter of 2008 was $1.8 million compared with
$2.4 million for the same period in 2007.
Restructuring Charges
The company incurred restructuring charges in the second and third quarters
of 2008 totaling $5.1 million. The charges resulted primarily from the
reduction in force initiated in April 2008 in response to the completion of
the company's Phase 3 development activities with telavancin and to reduce
its overall cash burn rate. The charges consisted primarily of employee and
severance benefits.
Cash and Cash Equivalents
Cash, cash equivalents and marketable securities totaled $218.8 million as
of September 30, 2008, a decrease of $13.5 million during the quarter. The
decrease was primarily due to cash used in operations and severance related
payments that were partially offset by a $10.0 million milestone payment
received from GSK for the successful achievement of proof-of-concept in the
MABA Phase 2 clinical study.
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
877-397-0235 from the U.S., or 719-325-4855 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 22, 2008. An audio replay will also be
available through 11:59 p.m. Eastern Standard Time on November 6, 2008 by
dialing 888-203-1112 from the U.S., or 719-457-0820 for international
callers, and entering confirmation code 4772510.
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: telavancin for the treatment of serious Gram-positive
bacterial infections with Astellas Pharma Inc., the Horizon program and
Bifunctional Muscarinic Antagonist-Beta2 agonist (MABA) program with
GlaxoSmithKline plc, and the Gastrointestinal Motility Dysfunction program.
By leveraging its proprietary insight of multivalency toward drug discovery
focused primarily on validated targets, Theravance is pursuing a next
generation 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.
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 expected timing of clinical studies and data from studies, statements
regarding the potential benefits and mechanisms of action of drug
candidates, statements concerning the timing of seeking regulatory approval
of our product candidates (including with respect to telavancin statements
regarding any expectation that regulatory authorities will approve
telavancin on the basis of existing preclinical and clinical data or at
all), 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 or operating cost savings and restructuring charges
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, 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
Item 1A of Theravance's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on August 7, 2008 and the risks
discussed in our other periodic 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 Nine Months Ended
September 30, September 30,
---------------------- ----------------------
2008 2007 2008 2007
---------- ---------- ---------- ----------
(unaudited) (unaudited)
Revenue (1) $ 5,999 $ 5,669 $ 17,149 $ 16,372
Operating expenses:
Research and development
(2) 20,075 31,964 66,850 124,319
General and
administrative (2) 6,494 8,462 22,916 26,772
Restructuring charges 50 -- 5,113 --
---------- ---------- ---------- ----------
Total operating expenses 26,619 40,426 94,879 151,091
---------- ---------- ---------- ----------
Loss from operations (20,620) (34,757) (77,730) (134,719)
Interest and other income,
net 1,209 2,414 4,176 7,855
Interest expense (1,517) (21) (4,164) (75)
---------- ---------- ---------- ----------
Net loss $ (20,928) $ (32,364) $ (77,718) $ (126,939)
========== ========== ========== ==========
Net loss per share $ (0.34) $ (0.53) $ (1.27) $ (2.10)
========== ========== ========== ==========
Shares used in computing
net loss per share 61,545 60,664 61,247 60,384
========== ========== ========== ==========
(1) Revenue includes amounts from GSK, a related party, of $3.3 million
and $9.0 million for the three and nine months ended
September 30, 2008, respectively, and $2.8 million and $8.5 million
for the three and nine months ended September 30, 2007, respectively.
(2) Amounts include stock-based compensation expense for the three and
nine months ended September 30 as follows (in thousands):
Three Months Ended Nine Months Ended
September 30, September 30,
----------------- -----------------
2008 2007 2008 2007
-------- -------- -------- --------
(unaudited) (unaudited)
Research and development $ 2,947 $ 3,514 $ 7,539 $ 10,078
General and administrative 1,810 2,359 5,863 7,089
-------- -------- -------- --------
Total stock-based compensation expense $ 4,757 $ 5,873 $ 13,402 $ 17,167
======== ======== ======== ========
THERAVANCE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
September 30, December 31,
2008 2007
------------- -------------
(unaudited) (2)
Assets
Cash, cash equivalents and marketable
securities $ 218,837 $ 126,816
Other current assets 8,890 7,271
Marketable securities - non-current -- 2,456
Property and equipment, net 17,328 20,091
Other assets 10,207 5,349
------------- -------------
Total assets $ 255,262 $ 161,983
============= =============
Liabilities and stockholders equity (net
capital deficiency)
Current liabilities, net of current portion
of deferred revenue $ 19,709 $ 33,014
Deferred revenue (1) 182,506 188,655
Convertible subordinated notes 172,500 --
Other long-term liabilities 5,699 6,578
Stockholders equity (net capital
deficiency) (125,152) (66,264)
------------- -------------
Total liabilities and stockholders equity
(net capital deficiency) $ 255,262 $ 161,983
============= =============
(1) Deferred revenue includes the current portion of $24.0 million
and $22.5 million as of September 30, 2008 and December 31, 2007,
respectively. Deferred revenue is the result of milestone payments
that were earned under the companys collaborations with Astellas
and GSK.
(2) The condensed consolidated balance sheet amounts at
December 31, 2007 are derived from audited financial statements.