Theravance Reports Third Quarter 2007 Financial Results
Thursday October 25, 4:15 pm ET
SOUTH SAN FRANCISCO, CA--(MARKET WIRE)--Oct 25, 2007 -- Theravance, Inc. (NasdaqGM:THRX - News) today reported financial results for the third quarter ended September 30, 2007. Net loss for the third quarter of 2007 was $32.4 million, compared with $37.8 million for the same period of 2006, a decrease of $5.4 million. Net loss per share was $0.53 for the third quarter of 2007 compared with a net loss per share of $0.63 for the third quarter of 2006.
"We continue to make progress across our major clinical programs," said Rick E Winningham, Chief Executive Officer. "In particular, we are very pleased that we successfully completed and achieved a positive outcome from our end-of-Phase 2 meeting with the FDA for compound TD-5108 for the treatment of chronic constipation. In July, we announced positive proof-of-concept data from an approximately 200-patient study with TD-1792, a novel antibiotic designed to treat resistant Gram-positive infections. Finally, earlier this week we announced that Theravance received an approvable letter from the FDA for telavancin, and we are working diligently toward submission of a complete response to the FDA."
Program Highlights
Bacterial Infections Programs
Telavancin
Earlier this week we announced that the U.S. Food and Drug Administration (FDA) issued an approvable letter 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). The FDA letter indicated that the telavancin application is approvable, subject to: resolution of current good manufacturing practices (cGMP) compliance issues not specifically related to telavancin at a third-party manufacturer; and submission of revised labeling or re-analyses of clinical data or additional clinical data. Astellas Pharma Inc. (Astellas) and Theravance believe that no additional clinical studies will need to be initiated to respond to the approvable letter. Telavancin is also under review for its safety and efficacy by regulatory authorities in Europe for the treatment of complicated skin and soft tissue infections and in Canada for the treatment of cSSSI.
Thirteen telavancin posters and a slide presentation on telavancin in cSSSI associated with surgical procedures were presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in September. In addition, telavancin posters were presented at the 45th Annual Meeting of the Infectious Diseases Society of America in October.
We are on track to report top-line data from our Phase 3 program in hospital-acquired pneumonia by the end of 2007.
TD-1792
In July we announced positive results from an approximately 200-patient study in cSSSI with TD-1792, our next-generation antibiotic for the treatment of Gram-positive infections, including resistant pathogens such as MRSA. We are evaluating the potential of this compound in more serious infections such as bacteremia.
Fourteen posters on TD-1792 were presented at ICAAC in September.
Respiratory Programs
Beyond Advair
In our collaboration with GlaxoSmithKline plc (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), GSK has advised us that the development program for the inhaled corticosteroid and LABA is progressing to plan.
Inhaled Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) Program
Our lead compound in the MABA program for the treatment of COPD, GSK961081, continues to progress and is expected to enter Phase 2 shortly.
Inhaled Long-Acting Muscarinic Antagonist (LAMA) Program
Our lead compound in the LAMA program for COPD has successfully completed pre-Phase 1 safety studies.
Gastrointestinal (GI) Motility Dysfunction Program
We recently obtained a positive outcome from our end-of-Phase 2 meeting with the FDA for TD-5108, our highly selective 5-HT4 receptor agonist for the treatment of GI motility dysfunction such as chronic idiopathic constipation (CIC) and constipation-predominant irritable bowel syndrome. The FDA confirmed that the TD-5108 data package, including the results of the approximately 400-patient Phase 2 ACCORD study reported by Theravance in June 2007, was adequate to progress TD-5108 into Phase 3 efficacy and safety studies in patients with CIC. The FDA also indicated that the size of the clinical program should be consistent with the International Conference on Harmonisation (ICH) guidelines for the development of drugs for chronic use. Additionally, we began enrolling patients in a Phase 1 thorough QTc study during the third quarter.
Financial Results
Revenue
Revenue was $5.7 million for the third quarter of 2007 compared with $5.5 million for the same period of 2006. This increase was due to higher amortization of upfront and milestone payments received from the company's strategic alliance with GSK and collaboration with 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 costs for the third quarter of 2007 decreased to $32.0 million compared with $39.1 million for the same period of 2006. This decrease was primarily driven by lower external research and development costs associated with telavancin. Total research and development stock-based compensation expense for the third quarter of 2007 was $3.5 million compared with $3.0 million for the same period in 2006. Total external research and development costs were $11.4 million in the third quarter of 2007 compared with $20.6 million in the same period of 2006.
General and Administrative
General and administrative costs for the third quarter of 2007 were $8.5 million compared with $7.9 million for the same period of 2006. This increase was primarily driven by higher stock-based compensation expense. Total general and administrative stock-based compensation expense for the third quarter of 2007 was $2.4 million compared with $1.7 million for the same period in 2006.
Cash and Cash Equivalents
Cash, cash equivalents and marketable securities totaled $166.5 million as of September 30, 2007, a decrease of $11.2 million during the quarter. This decrease was due to cash used in operations partially offset by a $25.0 million milestone payment received under our telavancin agreement with Astellas.
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 877-502-9272 from the U.S., or 913-981-5581 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 24, 2007. An audio replay will also be available through 11:59 p.m. Eastern Standard Time on November 8, 2007 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 4891018.
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, four are in late stage -- its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc., the Gastrointestinal Motility Dysfunction program, the Beyond Advair collaboration with GlaxoSmithKline plc and TD-1792 for the treatment of serious Gram-positive infections. By leveraging its proprietary insight of multivalency toward drug discovery focused on validated targets, Theravance is pursuing a next generation 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. |
