SOUTH SAN FRANCISCO, CA, Oct. 27, 2009 (Marketwire) --
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 10/27/09 -- Theravance, Inc. (NASDAQ: THRX) reported today its financial results for the quarter ended September 30, 2009. Net loss for the third quarter of 2009 was $22.2 million compared with $20.9 million for the same period in 2008. Net loss per share was $0.35 for the third quarter of 2009 compared with a net loss per share of $0.34 for the same period in 2008.
"In the third quarter, Theravance achieved significant milestones with the approval of VIBATIV(TM) in the United States and in Canada," said Rick E Winningham, Chief Executive Officer. "VIBATIV was discovered and developed by Theravance and is our first approved medicine. We believe that VIBATIV will provide an important new option for physicians treating complicated skin and skin structure infections caused by Gram-positive bacteria including MRSA. In the Horizon program, GlaxoSmithKline (GSK) and Theravance announced the initiation of the large Phase 3 program in COPD this morning and noted our full commitment to the development of the asthma program. We are excited about the accomplishments of Theravance and will continue to work diligently to advance our programs."
Key Program Highlights
Respiratory Programs
Horizon
Earlier today, GSK and Theravance reported that the first patient has commenced treatment in the Phase 3 program to develop a next-generation combination treatment for patients with chronic obstructive pulmonary disease (COPD). The Phase 3 program comprises a broad range of large scale Phase 3 studies to evaluate the investigational once-a-day long-acting beta agonist (LABA), 642444 ('444), in combination with the once-a-day inhaled corticosteroid (ICS), fluticasone furoate (FF), for the treatment of COPD. The overall program, which will study more than 6,000 patients, includes two 12-month exacerbation studies, two 6-month efficacy and safety studies, a detailed lung function profile study, and studies to assess the potential for superiority of the fixed combination of '444 and FF versus other treatments for COPD.
Bacterial Infections
Telavancin
On September 11, 2009, the U.S. Food and Drug Administration (FDA) approved VIBATIV(TM) (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. VIBATIV was also recently approved by Health Canada for the treatment of adult patients with cSSSI. In October, we announced that Theravance earned a milestone payment of $20.0 million for the FDA approval of VIBATIV and supplying its collaboration partner, Astellas Pharma US, Inc. (Astellas), with the launch inventory for the first commercial sale in the United States. It was also reported that Astellas recently began notifying wholesalers that it is now accepting orders for VIBATIV in preparation for a commercial launch during the fourth quarter of 2009.
The New Drug Application (NDA) for telavancin for the treatment of nosocomial pneumonia (NP) is currently under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of November 26, 2009. We believe that it is likely the review of the NDA will extend into 2010.
Eleven telavancin posters were presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, CA in September. In addition, telavancin posters will be presented at the 47th Annual Meeting of the Infectious Diseases Society of America in Philadelphia, PA from October 29 - November 1, 2009 and at CHEST 2009, the annual meeting of the American College of Chest Physicians (ACCP), in San Diego, CA from October 31 - November 5, 2009.
Financial Results
Revenue
Revenue was $5.5 million for the third quarter of 2009 compared with $6.0 million for the same period in 2008. Milestone payments received to date under our agreements with GSK and Astellas are being amortized over the relevant performance periods.
Research and Development
Research and development expense for the third quarter of 2009 decreased to $19.5 million from $20.1 million for the same period in 2008. Total external research and development expense for the third quarter of 2009 was $3.8 million compared with $5.0 million for the same period in 2008. The lower expenses in the third quarter of 2009 were primarily due to decreased external costs related to the regulatory process for telavancin. Total research and development stock-based compensation expense was $2.9 million for both the third quarter of 2009 and 2008.
General and Administrative
General and administrative expense for the third quarter of 2009 increased to $7.1 million from $6.5 million for the same period in 2008. The higher expense in the third quarter of 2009 was due to increased employee-related and stock-based compensation expenses that were partially offset by reduced facilities and external expenses. Total general and administrative stock-based compensation expense for the third quarter of 2009 was $2.1 million compared with $1.8 million for the same period in 2008.
Restructuring Charges
The company incurred restructuring charges totaling $1.3 million for the nine months ended September 30, 2009. The charges resulted primarily from a loss recognized on the sublease of excess space in one of the company's South San Francisco, CA buildings as well as employee severance and benefits resulting from the reduction in force announced in April 2008.
Cash and Cash Equivalents
Cash, cash equivalents and marketable securities totaled $154.2 million as of September 30, 2009, a decrease of $21.5 million during the 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 888-857-6930 from the U.S., or 719-457-2710 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 26, 2009. An audio replay will also be available through 11:59 p.m. Eastern Standard Time on November 3, 2009 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 5942530.
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.
