Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2014 Financial Results
Rick E Winningham, Chairman and Chief Executive Officer, commented: "In 2014, we successfully separated
- With VIBATIV, the Company expanded the field force supporting the commercial launch, initiated a Phase 3 bacteremia registrational study and initiated a patient registry study.
- The Company held discussions with the
FDAon the design of a Phase 3 program for TD-4208 in COPD and announced plans to initiate the Phase 3 program later this year.
- The Company announced an important strategic collaboration with Mylan to develop and, if approved, commercialize the nebulized formulation of TD-4208.
- The Company successfully co-formulated axelopran with the opiate OxyContin® as a fixed-dose combination in a Phase 1 study.
GSKand Theravance, Inc. announced initiation of a second global Phase 3 study to evaluate the effects of the Closed Triple in patients with COPD.
- In collaboration with partner
Alfa Wassermann, the Company prepared to initiate a Phase 2b study in gastroparesis with velusetrag.
Theravance Biopharma Programs
VIBATIV is a bactericidal, once-daily injectable antibiotic to treat patients with serious, life-threatening infections due to Staphylococcus aureus and other Gram-positive bacteria, including methicillin-resistant (MRSA) strains. VIBATIV is approved in the U.S. and
In 2014, we implemented a phased launch strategy for VIBATIV in the U.S. that focused on a small number of targeted geographic territories across the country. We have since expanded our sales force and medical affairs presence to include additional territories in the U.S. with the goal of strengthening our commercial infrastructure comprised of experienced sales representatives and a significant medical information component focused on the acute care market.
As part of our effort to explore additional settings in which VIBATIV may offer patients therapeutic benefit, in
TD-4208: Long-Acting Muscarinic Antagonist (LAMA)
TD-4208 is an investigational, long-acting muscarinic antagonist (LAMA) in development for the treatment of chronic obstructive pulmonary disease (COPD). We believe that TD-4208 may become a valuable addition to the COPD treatment regimen and that it represents a significant commercial opportunity. Our market research indicates approximately 9% of the treated COPD patients in the U.S. either need or prefer nebulized delivery for maintenance therapy. LAMAs are a cornerstone of maintenance therapy for COPD, but existing LAMAs are only available in handheld devices that may not be suitable for every patient. TD-4208 has the potential to be a best-in-class once-daily single-agent product for COPD patients who require, or prefer, nebulized therapy. The therapeutic profile of TD-4208, together with its physical characteristics, suggest that this LAMA could serve as a foundation for combination products and for delivery in metered dose inhaler and dry powder inhaler products.
Other Late-Stage Programs: Axelopran (TD-1211), Velusetrag, Closed Triple
Axelopran is an investigational, once-daily, oral peripherally active mu opioid receptor antagonist for opioid-induced constipation (OIC). The axelopran Phase 2 program demonstrated a clinically meaningful treatment effect in OIC patients compared to placebo. The goal for this program is to demonstrate the ability to normalize bowel function without impacting analgesia and improve a variety of GI symptoms associated with constipation, which could provide axelopran with a competitive advantage in the OIC market if demonstrated in Phase 3 studies and approved by regulatory authorities. We have developed a patient reported outcomes tool designed to measure patient symptoms which would be used in a Phase 3 registrational program and potentially generate data that could differentiate the product from the competition. We are currently refining our development and commercial strategy for axelopran.
Velusetrag is an oral, investigational medicine 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
The "Closed Triple" program seeks to provide the activity of fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) in a single delivery device. We have an 85% economic interest in future payments that may be made by
2014 Financial Results
The financial statements of
Revenue for the quarter ended
Cost of goods sold for the quarter ended
Research and Development (R&D)
R&D expenses for the quarter ended
Selling, General and Administrative (SG&A)
SG&A expenses for the quarter ended
Cash, cash equivalents and marketable securities, excluding restricted cash, totaled
Conference Call Today at
A replay of the conference call will be available on
The mission of
Our pipeline of internally discovered product candidates includes potential best-in-class opportunities in underserved markets in the acute care setting, representing multiple opportunities for value creation. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S. and
With our successful drug discovery and development track record, commercial infrastructure, experienced management team and efficient corporate structure, we believe that we are well positioned to create value for our shareholders and make a difference in the lives of patients.
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo, MEDICINES THAT MAKE A DIFFERENCE® and VIBATIV® are registered trademarks of the
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.
Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration.
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 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.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
|Three Months Ended||Year Ended|
|Revenue from collaborative arrangements (2)||124||175||7,270||226|
|Costs and expenses:|
|Cost of goods sold||3,222||-||4,058||-|
|Research and development (3)||42,192||32,470||168,522||120,579|
|Selling, general and administrative (3)||21,772||11,785||71,647||35,931|
|Total costs and expenses||67,186||44,255||244,227||156,510|
|Loss from operations||(65,753||)||(44,080||)||(232,539||)||(156,284||)|
|Interest and other income||983||-||1,865||-|
|Loss before income taxes||(64,770||)||(44,080||)||(230,674||)||(156,284||)|
|Provision (benefit) for income taxes||(460||)||-||6,364||-|
|Net loss per share:|
|Basic and diluted net loss per share||$||(2.02||)||$||(1.39||)||$||(7.46||)||$||(4.92||)|
|Shares used to compute basic and diluted net loss per share||31,782||31,741||31,755||31,741|
|(1)||The condensed consolidated statement of operations amounts for the year ended
|(2)||Revenue recognized from collaborative arrangements is as follows:|
|Three Months Ended||Year Ended|
|Clinigen Group plc||$||-||$||-||$||5,011||$||-|
|Total revenue from collaborative arrangements||$||124||$||175||$||7,270||$||226|
|(3)||Amounts include share-based compensation expense as follows:|
|Three Months Ended||Year Ended|
|Research and development||$||7,145||$||3,373||$||21,191||$||15,444|
|Selling, general and administrative||7,275||1,786||22,043||7,032|
|Total share-based compensation expense||$||14,420||$||5,159||$||43,234||$||22,476|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(In thousands, except per share data)|
|Cash, cash equivalents and marketable securities||$||306,010||$||-|
|Prepaid and other current assets||8,213||3,700|
|Property and equipment, net||9,663||10,238|
|Liabilities, shareholders' equity and parent company deficit|
|Current liabilities (2)||41,256||36,853|
|Shareholders' equity and parent company deficit||289,787||(17,035||)|
|Total liabilities, shareholders' equity and parent company deficit||$||337,771||$||25,177|
|(1)||The condensed consolidated balance sheet amounts at
|(2)||Amounts include the current portion of deferred revenue of
Chief Financial Officer
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