Theravance Reports 2013 Financial Results
"2013 was a transformative year for
Corporate Development
Separation Strategy
Activities related to the separation into two publicly traded companies are progressing with the goal of completing it in early 2014. In
Program Highlights
Respiratory Programs with GlaxoSmithKline plc (GSK)
RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol "FF/VI")
RELVAR®/BREO® ELLIPTA® has been approved by eight regulatory agencies for marketing and has been launched in seven countries as of
In
In
In
BREO® ELLIPTA® is the proprietary name in the U.S. and
Fluticasone Furoate/Vilanterol "FF/VI"
In
ANORO™ ELLIPTA™ (umeclidinium bromide/vilanterol,
On
ANORO™ ELLIPTA™ (umeclidinium and vilanterol inhalation powder) is the first once-daily product approved in the U.S. that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD. The
In addition, ANORO™ ELLIPTA™ (
Inhaled Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) - GSK961081
GSK961081 ('081) is an investigational, single molecule bifunctional bronchodilator with both muscarinic antagonist and beta2 receptor agonist activities. Preclinical Phase 3-enabling studies with the combination '081/FF are ongoing to explore its potential as a once-daily medicine delivered in the ELLIPTA™ inhaler.
Bacterial Infections Program
VIBATIV® (telavancin)
Central Nervous System (CNS)/Pain Programs
Norepinephrine and Serotonin Reuptake Inhibitor - TD-9855
TD-9855 is an investigational norepinephrine and serotonin reuptake inhibitor for the treatment of central nervous system conditions such as chronic pain. TD-9855 is being evaluated in an ongoing Phase 2 study in patients with fibromyalgia. Results from the Phase 2 study in fibromyalgia are anticipated to be reported during the first half of 2014.
GI Motility Dysfunction Program
Velusetrag
Velusetrag,
TD-8954
TD-8954 is a selective 5-HT4 receptor agonist.
Financial Results
Revenue
Revenue was
Research and Development (R&D)
Research and development expense for the full year of 2013 was
Selling, General and Administrative
Selling, general and administrative expense for the full year of 2013 was
Cash and Cash Equivalents, Short-Term Investments and
Cash and cash equivalents, short-term investments and marketable securities totaled
Conference Call and Webcast Information
As previously announced,
A replay of the conference call will be available on
About
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. 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 central nervous system (CNS)/pain. Theravance's key programs include: RELVAR®/BREO® ELLIPTA® (FF/VI), ANORO™ ELLIPTA™ (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance's web site at www.theravance.com.
RELVAR®, BREO®, ANORO™ and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.
VIBATIV® is a registered trademark of
BREO® ELLIPTA® Important Safety Information (U.S.)
The following ISI is based on the Highlights section of the U.S. Prescribing Information for BREO® ELLIPTA®. Please consult the full Prescribing Information for all the labeled safety information for BREO® ELLIPTA®.
Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol, one of the active ingredients in BREO® ELLIPTA®, increase the risk of asthma-related death. A placebo-controlled trial with another
BREO® ELLIPTA® is contraindicated in patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to either fluticasone furoate, vilanterol, or any of the excipients.
BREO® ELLIPTA® should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
BREO® ELLIPTA® should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABAs, as an overdose may result.
Oropharyngeal candidiasis has occurred in patients treated with BREO® ELLIPTA®. Patients should rinse their mouth with water without swallowing after inhalation to help reduce this risk.
An increase in the incidence of pneumonia has been observed in subjects with COPD receiving the fluticasone furoate/vilanterol combination, including BREO® ELLIPTA® 100 mcg/25 mcg, in clinical trials. There was also an increased incidence of pneumonias resulting in hospitalization. In some incidences these pneumonia events were fatal.
Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of inhaled corticosteroids in susceptible individuals.
Caution should be exercised when considering the coadministration of BREO® ELLIPTA® with long-term ketoconazole and other known strong CYP3A4 inhibitors because increased systemic corticosteroid and cardiovascular adverse effects may occur.
As with other inhaled medicines, BREO® ELLIPTA® can produce paradoxical bronchospasm which may be life-threatening. Vilanterol, the
BREO® ELLIPTA® should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients. Beta-adrenergic agonist medicines may produce transient hyperglycemia in some patients.
The most common adverse reactions (greater than or equal to 3% and more common than in placebo) reported in two 6-month clinical trials with BREO® ELLIPTA® (and placebo) were nasopharyngitis, 9% (8%); upper respiratory tract infection, 7% (3%); headache, 7% (5%); and oral candidiasis, 5% (2%). In addition to the events reported in the 6-month studies, adverse reactions occurring in greater than or equal to 3% of the subjects treated with BREO® ELLIPTA® in two 1-year studies included COPD, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, diarrhea, peripheral edema, and pyrexia.
ANORO™ ELLIPTA™ Important Safety Information (U.S.)
The following Important Safety Information (ISI) is based on the Highlights section of the Prescribing Information for ANORO™ ELLIPTA™. Please consult the full Prescribing Information for all the labeled safety information for ANORO™ ELLIPTA™.
Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol, one of the active ingredients in ANORO™ ELLIPTA™, increase the risk of asthma-related death. A placebo-controlled trial with another
ANORO™ ELLIPTA™ is contraindicated in patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to either umeclidinium, vilanterol, or any of the other ingredients.
ANORO™ ELLIPTA™ should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of bronchospasm, which should be treated with an inhaled, short-acting beta2-agonist.
ANORO™ ELLIPTA™ should not be used more often than recommended, at higher doses than recommended, or in conjunction with additional medicine containing a
ANORO™ ELLIPTA™ should be used with caution when considering coadministration with long-term ketoconazole and other known strong cytochrome P450 3A4 inhibitors because increased cardiovascular adverse effects may occur.
As with other inhaled medicines, ANORO™ ELLIPTA™ can produce paradoxical bronchospasm, which may be life-threatening.
ANORO™ ELLIPTA™ should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
ANORO™ ELLIPTA™ should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
ANORO™ ELLIPTA™ should be used with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician immediately should any signs or symptoms of narrow-angle glaucoma occur.
ANORO™ ELLIPTA™ should be used with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder neck obstruction. Instruct patients to contact a physician immediately should any signs or symptoms of urinary retention occur.
Beta-adrenergic agonist medicines may produce significant hypokalemia and transient hyperglycemia in some patients.
The most common adverse reactions (incidence greater than or equal to 1% and more common than placebo) reported in four 6-month clinical trials with ANORO™ ELLIPTA™ (and placebo) were pharyngitis, 2% (less than1%); sinusitis 1% (less than1%); lower respiratory tract infection, 1% (less than1%); constipation, 1% (less than1%); diarrhea, 2% (1%); pain in extremity 2% (1%); muscle spasms, 1% (less than1%); neck pain, 1% (less than1%); and chest pain 1% (less than1%). In addition to the 6-month efficacy trials with ANORO™ ELLIPTA™, a 12-month trial evaluated the safety of umeclidinium/vilanterol 125 mcg/25 mcg in subjects with COPD. Adverse reactions (incidence greater than or equal to 1% and more common than placebo) in subjects receiving umeclidinium/vilanterol 125 mcg/25 mcg were: headache, back pain, sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral respiratory tract infection, toothache, and diabetes mellitus.
Use of beta2-agonists, such as vilanterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated.
Use beta-blockers with caution as they not only block the pulmonary effect of beta-agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD.
Use with caution in patients taking non-potassium-sparing diuretics, as electrocardiographic changes and/or hypokalemia associated with non-potassium-sparing diuretics may worsen with concomitant beta-agonists.
Avoid co-administration of ANORO™ ELLIPTA™ with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects such as cardiovascular effects, worsening of narrow-angle glaucoma, and worsening of urinary retention.
VIBATIV® Important Safety Information (U.S.)
Mortality
Patients with pre-existing moderate/severe renal impairment (CrCl less than or equal to 50 mL/min) who were treated with VIBATIV® for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus vancomycin. Use of VIBATIV® in patients with pre-existing moderate/severe renal impairment (CrCl less than or equal to 50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.
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.
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.
Contraindication
VIBATIV® is contraindicated in patients with a known hypersensitivity to the drug.
Hypersensitivity Reactions
Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. VIBATIV® should be used with caution in patients with known hypersensitivity to vancomycin.
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.
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.
Most Common Adverse Reactions
The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV®) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.
Full Prescribing Information, including Boxed Warning and Medication Guide in the U.S., is available at 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.
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| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
| (In thousands, except per share data) | |||||||||||||||||
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Three Months Ended |
Twelve Months Ended |
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| 2013 | 2012 | 2013 | 2012 | ||||||||||||||
| (unaudited) | (unaudited) | (1) | |||||||||||||||
| Net royalty revenue | $ | 1,202 | $ | - | $ | 1,202 | $ | - | |||||||||
| Revenue from collaborative arrangements | 446 | 5,799 | 3,556 | $ | 135,758 | ||||||||||||
| Total net revenue (2) | 1,648 | 5,799 | 4,758 | 135,758 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development (3) | 33,631 | 28,120 | 125,181 | 117,898 | |||||||||||||
| Selling, general and administrative (3) | 16,467 | 7,658 | 48,440 | 30,859 | |||||||||||||
| Total operating expenses | 50,098 | 35,778 | 173,621 | 148,757 | |||||||||||||
| Loss from operations | (48,450 | ) | (29,979 | ) | (168,863 | ) | (12,999 | ) | |||||||||
| Other income (expense), net (4) | (2 | ) | - | 6,732 | - | ||||||||||||
| Interest income | 211 | 156 | 778 | 460 | |||||||||||||
| Interest expense | (1,687 | ) | (1,500 | ) | (9,348 | ) | (6,003 | ) | |||||||||
| Net loss | $ | (49,928 | ) | $ | (31,323 | ) | $ | (170,701 | ) | $ | (18,542 | ) | |||||
| Basic and diluted net loss per common share | $ | (0.46 | ) | $ | (0.33 | ) | $ | (1.67 | ) | $ | (0.20 | ) | |||||
| Shares used to compute basic and diluted net loss per common share | 108,667 | 95,787 | 102,425 | 90,909 | |||||||||||||
| (1) |
The condensed consolidated statement of operations amounts for the year ended |
| (2) | Net revenue is comprised of the following (in thousands): |
|
Three Months Ended |
Twelve Months Ended |
|||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||
| (unaudited) | (unaudited) | (1) | ||||||||||||
| Royalty revenue | $ | 1,945 | $ | -- | $ | 1,945 | $ | -- | ||||||
| Amortization of intangible assets | (743 | ) | -- | (743 | ) | -- | ||||||||
| Net royalty revenue | 1,202 | -- | 1,202 | -- | ||||||||||
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-- | 907 | 1,815 | 3,629 | ||||||||||
| Strategic alliance--MABA program license | 271 | 415 | 1,515 | 1,984 | ||||||||||
| Total net revenue from GSK | 1,473 | 1,322 | 4,532 | 5,613 | ||||||||||
| Revenue from other collaborative arrangements | 175 | 4,477 | 226 | 130,145 | ||||||||||
| Total net revenue | $ | 1,648 | $ | 5,799 | $ | 4,758 | $ | 135,758 | ||||||
| (3) |
Amounts include stock-based compensation expense for the three months and twelve months ended |
|
Three Months Ended |
Twelve Months Ended |
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| 2013 | 2012 | 2013 | 2012 | |||||||||
| (unaudited) | (unaudited) | (1) | ||||||||||
| Research and development | $ | 3,521 | $ | 3,338 | $ | 16,017 | $ | 13,667 | ||||
| Selling, general and administrative | 2,463 | 2,401 | 9,670 | 10,116 | ||||||||
| Total stock-based compensation expense | $ | 5,984 | $ | 5,739 | $ | 25,687 | $ | 23,783 | ||||
| (4) |
For the year ended |
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| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands) | ||||||||
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| 2013 | 2012 | |||||||
| (unaudited) | (1) | |||||||
| Assets | ||||||||
| Cash, cash equivalents, short-term investments, and marketable securities | $ | 520,499 | $ | 343,683 | ||||
| Other current assets | 7,667 | 5,130 | ||||||
| Inventories | 10,406 | 7,514 | ||||||
| Property and equipment, net | 10,238 | 9,154 | ||||||
| Intangible assets, net | 124,257 | - | ||||||
| Other assets | 8,188 | 3,101 | ||||||
| Total assets | $ | 681,255 | $ | 368,582 | ||||
| Liabilities and stockholders' equity (net capital deficiency) | ||||||||
| Other current liabilities (2) | $ | 44,404 | $ | 29,966 | ||||
| Payable to related-party | 40,000 | - | ||||||
| Deferred revenue, non-current | 5,455 | 6,014 | ||||||
| Convertible subordinated notes | 287,500 | 172,500 | ||||||
| Other long-term liabilities | 4,774 | 5,074 | ||||||
| Stockholders' equity | 299,122 | 155,028 | ||||||
| Total liabilities and stockholders' equity (net capital deficiency) | $ | 681,255 | $ | 368,582 | ||||
| (1) |
The condensed consolidated balance sheet amounts at |
| (2) |
Amounts include current portion of deferred revenue of |
Contact Information:
Senior Vice President and Chief Financial Officer
650-808-4100
investor.relations@theravance.com
Source:
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