Theravance Biopharma, Inc. Reports First Quarter 2015 Financial Results
Rick E Winningham, Chairman and Chief Executive Officer, commented: "We achieved our objectives and made good progress in advancing key programs during the first quarter. The expansion of our field force, and the initiation of the TOUR and bacteremia studies are helping to build the VIBATIV® (telavancin) brand, and plans are underway for additional commercial expansion this year to further drive market uptake. We are on track to initiate a Phase 3 registrational program in TD-4208 in COPD later this year, in collaboration with Mylan. Additional progress includes the initiation of a Phase 2b study of velusetrag, partnered with
First Quarter 2015 Highlights and Business Update
- Expanded field force driving market uptake of VIBATIV: commencing further expansion of sales force to 50 representatives, based on steady account growth, new formulary wins and sales growth in target regions.
- Phase 3 bacteremia registrational study enrolling patients: designed to support regulatory filing for telavancin as a treatment for Staphylococcus aureus bacteremia.
- TOUR patient registry study enrolling: designed to generate real-world data to guide future development and optimal use of VIBATIV.
- TD-4208 Phase 3 registrational program in COPD to begin in the second half 2015: plan includes two replicate three-month efficacy studies and a single twelve-month safety study.
- Velusetrag Phase 2b study progressing: testing the efficacy, safety and tolerability of velusetrag in the treatment of patients with gastroparesis.
- Novel neprilysin inhibitor development candidates for heart failure moving from research into IND-enabling toxicology studies: targeting initiation of Phase 1 in late 2015/early 2016.
- Ulcerative colitis development candidate advancing into IND-enabling toxicology studies; targeting initiation of Phase 1 in late 2015/early 2016.
First Quarter 2015 Financial Results
On
The financial statements of
Revenue
Product sales of VIBATIV for the quarter ended
Revenue from collaborative arrangements 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, cash equivalents and marketable securities, excluding restricted cash, totaled
Revised 2015 Financial Guidance
The Company is lowering its full year 2015 operating loss guidance to
The updated guidance reflects a reduction in operating loss due to revenues and reimbursements received from Mylan, offset by an increase in investment in both VIBATIV commercialization and early development programs. The Company is investing in VIBATIV by expanding its sales force commencing in Q2 2015. The investment in early development programs reflects the decision to advance multiple product candidates from the Company's neprilysin inhibitor and ulcerative colitis programs towards the clinic.
The Company is targeting VIBATIV net sales of approximately
Conference Call Today at
A replay of the conference call will be available on
About
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.)
Mortality
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.
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
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.
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
(Unaudited) | ||||||||||
(In thousands, except per share data) | ||||||||||
Three Months Ended |
||||||||||
2015 | 2014 | |||||||||
Revenue: | ||||||||||
Product sales | $ | 1,280 | $ | 945 | ||||||
Revenue from collaborative arrangements | 19,121 | - | ||||||||
Total revenue | 20,401 | 945 | ||||||||
Costs and expenses: | ||||||||||
Cost of goods sold | 371 | 188 | ||||||||
Research and development (1) | 36,019 | 42,558 | ||||||||
Selling, general and administrative (1) | 21,748 | 18,217 | ||||||||
Total costs and expenses | 58,138 | 60,963 | ||||||||
Loss from operations | (37,737 | ) | (60,018 | ) | ||||||
Interest and other income | 211 | - | ||||||||
Loss before income taxes | (37,526 | ) | (60,018 | ) | ||||||
Provision for income taxes | 4,948 | - | ||||||||
Net loss | $ | (42,474 | ) | $ | (60,018 | ) | ||||
Net loss per share: | ||||||||||
Basic and diluted net loss per share | $ | (1.29 | ) | $ | (1.89 | ) | ||||
Shares used to compute basic and diluted net loss per share | 32,830 | 31,741 | ||||||||
(1) Amounts include share-based compensation expense as follows:
Three Months Ended |
|||||||
(In thousands) | 2015 | 2014 | |||||
Research and development | $ | 7,482 | $ | 5,556 | |||
Selling, general and administrative | 8,144 | 7,145 | |||||
Total share-based compensation expense | $ | 15,626 | $ | 12,701 | |||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(In thousands, except per share data) | ||||||||
2015 | 2014 | |||||||
(Unaudited) | (1) | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents and marketable securities | $ | 274,757 | $ | 306,010 | ||||
Receivables from collaborative arrangements (2) | 19,660 | 1,840 | ||||||
Prepaid and other current assets | 7,323 | 6,373 | ||||||
Inventories | 12,337 | 12,546 | ||||||
Restricted cash | 833 | 833 | ||||||
Property and equipment, net | 9,305 | 9,663 | ||||||
Other assets | 686 | 506 | ||||||
Total assets | $ | 324,901 | $ | 337,771 | ||||
Liabilities and Shareholders' Equity: | ||||||||
Current liabilities (3) | $ | 28,852 | $ | 41,256 | ||||
Long-term liabilities | 6,934 | 6,728 | ||||||
Shareholders' equity | 289,115 | 289,787 | ||||||
Total liabilities and shareholders' equity | $ | 324,901 | $ | 337,771 | ||||
Note 1: The condensed consolidated balance sheet at
Note 2: Receivables from collaborative arrangements at
Note 3: Amounts include the current portion of deferred revenue of
Contact Information:
Renee Gala
Chief Financial Officer
650-808-4045
investor.relations@theravance.com
Source:
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