Theravance Reports Fourth Quarter and Full Year 2012 Financial Results
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Program Highlights
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
In
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.
In
Inhaled Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA)
GSK961081 ('081) is an investigational, single molecule bifunctional bronchodilator with both muscarinic antagonist and beta2 receptor agonist activities. Based on the results from the Phase 2b study, GSK and
Bacterial Infections Program
VIBATIV® (telavancin)
In November, 2012,
Central Nervous System (CNS)/Pain Program
Oral Peripheral Mu Opioid Receptor Antagonist - TD-1211
TD-1211 is an investigational once-daily, orally administered, peripherally selective, multivalent inhibitor of the mu opioid receptor designed with a goal of alleviating gastrointestinal side effects of opioid therapy without affecting analgesia. In
Monoamine Reuptake Inhibitor - TD-9855
TD-9855 is an investigational norepinephrine and serotonin reuptake inhibitor for the treatment of central nervous system conditions such as Attention-Deficit/Hyperactivity Disorder (ADHD) and chronic pain. TD-9855 is being evaluated in an ongoing Phase 2 safety and efficacy study in adults with ADHD. In addition, we initiated a Phase 2 study with TD-9855 in patients with fibromyalgia in
Theravance Respiratory Program
Long-Acting Muscarinic Antagonist - TD-4208
In
GI Motility Dysfunction Program
Velusetrag
Velusetrag, an oral, investigational medicine dosed once daily, is a highly selective agonist with high intrinsic activity at the human 5-HT4 receptor. In
Financial Results
Revenue
Revenue was
Research and Development
Research and development expense for the fourth quarter of 2012 decreased to
General and Administrative
General and administrative expense for the fourth quarter of 2012 decreased to
Cash and Cash Equivalents
Cash, cash equivalents and marketable securities totaled
Conference Call and Webcast Information
As previously announced,
A replay of the conference call will be available on
About
THERAVANCE®, the
RELVAR™ or BREO™ (FF/VI) and ANORO™ (UMEC/VI) are investigational medicines and are not currently approved anywhere in the world. RELVAR™, BREO™, ANORO™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies. The use of these brand names has not yet been approved by any regulatory authority.
VIBATIV® is a registered trademark of
VIBATIV® Important Safety Information (U.S.)
Fetal Risk
Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV®. Avoid use of VIBATIV® during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV® treatment.
Nephrotoxicity
New onset or worsening renal impairment occurred in patients who received VIBATIV®. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV® prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV® versus discontinuing and initiating therapy with an alternative agent should be assessed. Clinical cure rates in telavancin-treated patients were lower in patients with baseline CrCl ≤ 50 mL/min compared to those with CrCl > 50 mL/min. Consider these data when selecting antibacterial therapy for use in patients with baseline moderate/severe renal impairment.
Geriatric Use
Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.
Infusion Related Reactions
VIBATIV® is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause "Red-man Syndrome" like reactions including: flushing of the upper body, urticaria, pruritus, or rash.
Clostridium difficile-Associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use.
Development of Drug-Resistant Bacteria
Prescribing VIBATIV® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. As with other antibacterial drugs, use of VIBATIV® may result in overgrowth of nonsusceptible organisms, including fungi.
QTc Prolongation
Caution is warranted when prescribing VIBATIV® to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV® prolonged the QTc interval. Use of VIBATIV® should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.
Coagulation Test Interference
VIBATIV® does not interfere with coagulation, but does interfere with certain tests used to monitor coagulation such as prothrombin time, international normalized ratio, activated partial thromboplastin time, activated clotting time, and coagulation based factor Xa tests. Blood samples for these coagulation tests should be collected as close as possible prior to a patient's next dose of VIBATIV®.
Adverse Reactions
The most common adverse reactions (≥ 10% of patients treated with VIBATIV®) observed in the Phase 3 cSSSI clinical trials were taste disturbance, nausea, vomiting, and foamy urine.
In the Phase 3 cSSSI clinical trials, serious adverse events were reported in 7% of patients treated with VIBATIV® and most commonly included renal, respiratory, or cardiac events. Serious adverse events were reported in 5% of vancomycin-treated patients, and most commonly included cardiac, respiratory, or infectious events.
For full Prescribing Information, including Boxed Warning and Medication Guide in the US, please visit www.VIBATIV.com.
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.
(THRX-F)
THERAVANCE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended Twelve Months Ended
December 31, December 31,
---------------------- -----------------------
2012 2011 2012 2011
---------- ---------- ----------- ----------
(unaudited) (unaudited) (2)
---------------------- ----------- ----------
Revenue $ 5,799 $ 5,361 $ 135,758 $ 24,512
Operating expenses:
Research and development
(1) 28,120 32,468 117,898 103,568
General and
administrative (1) 7,658 8,469 30,859 30,681
---------- ---------- ----------- ----------
Total operating expenses 35,778 40,937 148,757 134,249
---------- ---------- ----------- ----------
Loss from operations (29,979) (35,576) (12,999) (109,737)
Interest and other income 156 71 460 415
Interest expense (1,500) (1,502) (6,003) (6,022)
---------- ---------- ----------- ----------
Net loss $ (31,323) $ (37,007) $ (18,542) $ (115,344)
========== ========== =========== ==========
Net loss per share:
Basic and Diluted $ (0.33) $ (0.45) $ (0.20) $ (1.41)
========== ========== =========== ==========
Weighted average shares:
Basic and Diluted 95,787 82,862 90,909 82,051
========== ========== =========== ==========
(1) Amounts include stock-based compensation expense for the three months
and twelve months ended December 31 as follows (in thousands):
Three Months Ended Twelve Months Ended
December 31, December 31,
----------------------- ------------------------
2012 2011 2012 2011
----------- ----------- ------------ -----------
(unaudited) (unaudited)
Research and development $ 3,338 $ 3,401 $ 13,667 $ 13,422
General and administrative 2,401 2,809 10,116 11,494
----------- ----------- ------------ -----------
Total stock-based
compensation expense $ 5,739 $ 6,210 $ 23,783 $ 24,916
=========== =========== ============ ===========
(2) The condensed consolidated statement of operations amounts for the year
ended December 31, 2011 are derived from audited financial statements.
THERAVANCE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
December 30, December 31,
2012 2011
------------- ------------
(unaudited) (1)
------------- ------------
Assets
Cash, cash equivalents and marketable
securities $ 343,683 $ 240,915
Other current assets 5,130 3,848
Inventory 7,514 --
Property and equipment, net 9,154 10,372
Other assets 3,101 3,647
------------- ------------
Total assets $ 368,582 $ 258,782
============= ============
Liabilities and stockholders' equity (net
capital deficiency)
Current liabilities (2) $ 29,966 $ 45,496
Deferred revenue, non-current 6,014 122,017
Convertible subordinated notes 172,500 172,500
Other long-term liabilities 5,074 5,821
Stockholders' equity (net capital deficiency) 155,028 (87,052)
------------- ------------
Total liabilities and stockholders' equity
(net capital deficiency) $ 368,582 $ 258,782
============= ============
(1) The condensed consolidated balance sheet amounts at December 31, 2011
are derived from audited financial statements.
(2) Amounts include current portion of deferred revenue of $4.6 million and
$18.7 million as of December 31, 2012 and December 31, 2011 ,
respectively.
Contact Information:Michael W. Aguiar Senior Vice President and Chief Financial Officer 650-808-4100 investor.relations@theravance.com
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