SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 02/12/13 -- Theravance, Inc. (NASDAQ: THRX) (the "Company") reported today its financial results for the fourth quarter and full year ended December 31, 2012. Revenue for the full year was $135.8 million. Net loss for the fourth quarter and full year of 2012 was $31.3 million and $18.5 million, respectively, compared with $37.0 million and $115.3 million for the same periods of 2011. Net loss per share was $0.33 and $0.20 for the fourth quarter and full year of 2012, respectively, compared with a net loss per share of $0.45 and $1.41 for the same periods of 2011. Cash, cash equivalents, and marketable securities totaled $343.7 million as of December 31, 2012, an increase of $102.8 million from December 31, 2011.
"Theravance made significant progress in 2012, particularly in our lead respiratory programs partnered with GSK," said Rick E Winningham, Chief Executive Officer. "Looking forward, 2013 will be more significant for Theravance with potential regulatory events for RELVAR/BREO, ANORO, and VIBATIV®. In addition, we continue to progress our internal programs, including Phase 2 studies in fibromyalgia and ADHD with TD-9855, a Phase 2b study in COPD with TD-4208, and a Phase 2 study in gastroparesis with velusetrag. Overall, we are well positioned both strategically and financially."
Respiratory Programs with GlaxoSmithKline plc (GSK)
RELVAR or BREO (Fluticasone Furoate/Vilanterol, FF/VI)
FF/VI is an investigational once-daily inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) combination treatment, comprising fluticasone furoate (FF) and vilanterol (VI), for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and patients with asthma. FF/VI is administered by a new dry powder inhaler called ELLIPTA. RELVAR (FF/VI for the European Union (EU) and Japan), BREO (FF/VI for the United States (U.S.)), and ELLIPTA (for the EU, U.S. and Japan) are proposed brand names and use of these brand names has not yet been approved by any regulatory authority.
In September 2012, GSK and Theravance announced that the New Drug Application (NDA) for FF/VI for patients with COPD was accepted by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act goal date was confirmed as May 12, 2013 and the FDA's Pulmonary-Allergy Drugs Advisory Committee is scheduled to discuss the NDA for BREO for COPD at a meeting on March 7, 2013. GSK and Theravance also reported that the Marketing Authorization Application for FF/VI for COPD and asthma was validated by the European Medicines Agency (EMA) and GSK also submitted a Japanese New Drug Application for FF/VI for patients with COPD and asthma in September 2012.
ANORO (Umeclidinium Bromide/Vilanterol, UMEC/VI)
UMEC/VI is a once-daily investigational medicine, combining a long-acting muscarinic antagonist (LAMA), UMEC, and a LABA, VI, for the maintenance treatment of patients with COPD. UMEC/VI is administered by the ELLIPTA dry powder inhaler.
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