Theravance Biopharma, Inc. Reports Second Quarter 2014 Financial Results
"We are excited to move forward as a newly independent entity, with a legacy of achievement in discovering, developing and commercializing important medicines for patients," commented Rick E Winningham, Chairman and Chief Executive Officer. "We look forward to sharing more details regarding our strategy and portfolio of differentiated assets during an Investor & Analyst Day event expected to take place in the fourth quarter. We believe that the productivity of our R&D organization, combined with the advantages of our corporate structure, strong cash position and quality of our management team and organization, afford us a range of options to build shareholder value, create medicines for patients that make a difference in their lives, and establish
Theravance Biopharma Respiratory Program
Long-Acting Muscarinic Antagonist (LAMA) - TD-4208
TD-4208 is currently in a dose-ranging Phase 2b study as a nebulized aqueous solution in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), and the Company expects to report top-line data in the fourth quarter of 2014. TD-4208 is a once-daily inhaled nebulized muscarinic antagonist discovered internally for the treatment of a subset of COPD patients that the Company believes are underserved by current hand-held products. The Company believes that TD-4208 has the potential to serve as a foundation for several combination nebulized products as well as potential metered dose inhaler or dry powder inhaler products. Positive top-line data from a Phase 2b study to evaluate the bronchodilatory effect, pharmacokinetics, safety and tolerability of multiple doses of TD-4208 were announced in
Bacterial Infections Program
The Company is currently commercializing VIBATIV® in the U.S. through a targeted program consisting of a small number of sales representatives and medical science liaisons supporting physician education on the proper usage of VIBATIV®.
VIBATIV® (telavancin) is a bactericidal, once-daily injectable antibiotic discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including methicillin-resistant (MRSA) strains. VIBATIV® is approved in the U.S. and
The Company plans to progress VIBATIV® into a registrational study for the treatment of patients with bacteremia and a patient registry study, with an objective of generating additional safety and efficacy data that can further elucidate the potential therapeutic benefit and utilization of VIBATIV®.
GI Motility Dysfunction Programs
Velusetrag is an oral, investigational medicine discovered internally and developed for gastrointestinal motility disorders. It is a highly selective agonist with high intrinsic activity at the human 5-HT4 receptor.
Velusetrag is being developed in collaboration with
TD-8954, like velusetrag, is an internally discovered highly selective agonist with high intrinsic activity at the human 5-HT4 receptor. The Company is investigating the development potential of TD-8954 for acute use in the hospital setting for patients who require rapid restoration of upper and lower GI motility. The Company believes that TD-8954 may help hospitalized patients with enteral feeding intolerance, or EFI, and potentially other GI disorders. A Phase 2a study evaluating the safety, tolerability and pharmacodynamics of a single dose of TD-8954 administered intravenously compared to metoclopramide in critically ill patients with EFI is ongoing.
Central Nervous System (CNS)/Pain Program
Oral Peripheral Mu Opioid Receptor Antagonist - Axelopran (TD-1211)
Axelopran is an internally discovered 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
Positive results from a Phase 2 study of TD-9855, an internally discovered investigational norepinephrine and serotonin reuptake inhibitor (NSRI), in patients with fibromyalgia were announced in
Economic Interests in GlaxoSmithKline plc (GSK) Respiratory Programs Partnered with Theravance
"Closed Triple" or FF/UMEC/VI (fluticasone furoate/umeclidinium bromide/vilanterol)
The "closed triple" program seeks to provide the activity of an inhaled corticosteroid (FF) plus two bronchodilators (UMEC, a LAMA, and VI, a long-acting beta2 agonist or LABA) in a single delivery device. If the "closed triple" is successfully developed and commercialized, TRC is entitled to receive upward-tiering royalties from 6.5% to 10% from GSK on worldwide net sales. 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 (MABA) activity that was discovered by the Company when it was part of Theravance. Earlier this month, Theravance reported that preclinical Phase 3-enabling studies and a Phase 1 study with healthy volunteers of '081/FF are ongoing to explore its potential as a once-daily medicine delivered in GSK's ELLIPTA® inhaler.
If a single-agent MABA medicine containing '081 is successfully developed and commercialized, TRC is entitled to receive royalties from GSK of between 10% and 20% of annual global net sales up to
Due to the completion of the Spin-Off on
Total revenue in the second quarter was
Research and Development (R&D)
Research and development expenses for the second quarter of 2014 were
Selling, General and Administrative (SG&A)
Selling, general and administrative expenses for the second quarter of 2014 were
Cash and Cash Equivalents, Short-Term Investments and
Cash and cash equivalents, short-term investments and marketable securities totaled
THERAVANCE, the Cross/Star logo, MEDICINES THAT MAKE A DIFFERENCE and VIBATIV are trademarks and/or registered trademarks of the
RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.
VIBATIV® Important Safety Information (U.S.)
Patients with pre-existing moderate/severe renal impairment (CrCl ≤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 ≤50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.
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.
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.
VIBATIV® is contraindicated in patients with a known hypersensitivity to the drug.
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.
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.
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 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.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
|Three Months Ended
||Six Months Ended
|Revenue from collaboration agreements||2,113||5||2,113||27|
|Total revenue (1)||2,974||5||3,919||27|
|Costs and expenses:|
|Cost of goods sold||279||-||467||-|
|Research and development (2)||46,283||30,400||88,006||55,808|
|Selling, general and administrative (2)||13,118||8,557||32,170||15,345|
|Total costs and expenses||59,680||38,957||120,643||71,153|
|Loss from operations||(56,706||)||(38,952||)||(116,724||)||(71,126||)|
|Loss before income taxes||(56,492||)||(38,952||)||(116,510||)||(71,126||)|
|Provision for income taxes||(1,723||)||-||(1,723||)||-|
|Net loss per share:|
|Basic and diluted net loss per share||$||(1.83||)||$||(1.23||)||$||(3.72||)||$||(2.24||)|
|Shares used to compute basic and diluted net loss per share||31,768||31,768||31,768||31,768|
(1) Revenue recognized from collaborative agreements is as follows (in thousands):
|Three months Ended
||Six months Ended
|Total revenue from collaborative agreements||$||2,113||$||5||$||2,113||$||27|
(2) Amounts include stock-based compensation expense as follows (in thousands):
|Three Months Ended
||Six Months Ended
|Research and development||$||4,194||$||4,310||$||8,914||$||7,998|
|Selling, general and administrative||2,570||1,897||10,550||3,725|
|Total share-based compensation expense||$||6,764||$||6,207||$||19,464||$||11,723|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash, cash equivalents, short-term investments, and marketable securities||$||387,427||$||--|
|Receivable from Theravance, Inc.||15,243||--|
|Other current assets||3,538||3,700|
|Property and equipment, net||9,624||10,238|
|Liabilities and stockholders' equity|
|Other current liabilities (2)||$||40,111||$||36,853|
|Deferred revenue, non-current||729||585|
|Other long-term liabilities||4,989||4,774|
|Stockholders' equity and parent company deficit||384,759||(17,035||)|
|Total liabilities and stockholders' equity and parent company deficit||$||430,588||$||25,177|
(1) The condensed consolidated balance sheet amounts at
(2) Amounts include current portion of deferred revenue of
Rick E Winningham
Chief Executive Officer
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