Theravance Biopharma, Inc. Reports Third Quarter 2017 Financial Results and Provides Business Update
Rick E Winningham, Chairman and Chief Executive Officer, commented: "In 2017, we continue to demonstrate the potential of our portfolio with encouraging clinical data across multiple key programs. Looking forward, we are positioned to achieve numerous clinical and regulatory milestones, with a plan to deliver on the promise of developing differentiated medicines for patients in need."
Recent Updates1
- Trelegy Ellipta (the combination of fluticasone furoate, umeclidinium, and vilanterol, previously referred to as the Closed Triple) approved in the US for the treatment of chronic obstructive pulmonary disease (COPD) in appropriate patients
European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion of Trelegy Ellipta, recommending marketing authorization for the product- Landmark IMPACT study met primary endpoint showing reduction in exacerbations with Trelegy Ellipta compared to dual therapies in patients with COPD; safety findings were consistent with the known profile of individual medicines and their dual combinations; regulatory filings for IMPACT data expected in 2018
Expected Upcoming Milestones and Events
- Revefenacin (TD-4208, a once-daily nebulized long-acting muscarinic antagonist (LAMA) for COPD): NDA filing anticipated in 4Q 2017; potential regulatory approval in the US for COPD in 2018; Phase 3b PIFR study, designed to support commercialization, expected to complete in 1Q 2018
- Trelegy Ellipta1: Commercial launch expected
mid-November 2017 ; economic interest related to Trelegy Ellipta entitlesTheravance Biopharma to upward tiering royalty of 5.5% to 8.5% on worldwide net sales; potential regulatory approval in the EU for COPD in late 2017; Phase 3 CAPTAIN study in asthma patients expected to complete in 2018 - TD-1473 (intestinally restricted pan-Janus kinase (JAK) inhibitor): Data from the remaining cohorts of the Phase 1b study in patients with ulcerative colitis in 2018; targeting initiation of large, multi-dose induction and maintenance study in 2018
- TD-9855 (norepinephrine serotonin reuptake inhibitor (NSRI)): Data from the Phase 2a study in patients with nOH in first half of 2018
- VIBATIV: Televancin Observational Use Registry (TOURTM) data to be published in 2018; data from the Phase 3 registrational bacteremia study in 2018 or 2019
Notes:
1 As reported by
Third Quarter Financial Results
Revenue
Revenue for the third quarter of 2017 was
Research and Development (R&D) Expenses
R&D expenses for the third quarter of 2017 were
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the third quarter of 2017 were
Other-than-Temporary Impairment Loss
In the third quarter, a non-cash impairment charge of
Cash,
Cash, cash equivalents and marketable securities, excluding restricted cash, totaled
2017 Financial Guidance
The Company's guidance on operating loss excluding non-cash share-based compensation for the full-year of 2017 remains unchanged at
Conference Call Today at
A replay of the conference call will be available on
About
Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S.,
In addition, we have an economic interest in future payments that may be made by
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo, and VIBATIV® are registered trademarks of the
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, expectations and future events.
Contact Information:
Head of Investor Relations
650-808-4045
investor.relations@theravance.com
THERAVANCE BIOPHARMA, INC. |
||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||
(In thousands, except per share data) |
||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||
2017 |
2016 |
2017 |
2016 |
|||||||||
(Unaudited) |
(Unaudited) |
|||||||||||
Revenue: |
||||||||||||
Product sales |
$ |
4,140 |
$ |
3,901 |
$ |
10,664 |
$ |
12,571 |
||||
Revenue from collaborative arrangements |
135 |
15,174 |
207 |
30,385 |
||||||||
Total revenue |
4,275 |
19,075 |
10,871 |
42,956 |
||||||||
Costs and expenses: |
||||||||||||
Cost of goods sold |
985 |
332 |
2,914 |
1,748 |
||||||||
Research and development (1) |
39,343 |
31,951 |
122,835 |
99,698 |
||||||||
Selling, general and administrative (1) |
20,944 |
20,286 |
66,069 |
64,143 |
||||||||
Total costs and expenses |
61,272 |
52,569 |
191,818 |
165,589 |
||||||||
Loss from operations |
(56,997) |
(33,494) |
(180,947) |
(122,633) |
||||||||
Interest expense |
(2,136) |
- |
(6,410) |
- |
||||||||
Other-than-temporary impairment loss |
(8,000) |
- |
(8,000) |
- |
||||||||
Interest and other income (expense), net |
1,124 |
344 |
3,579 |
839 |
||||||||
Loss before income taxes |
(66,009) |
(33,150) |
(191,778) |
(121,794) |
||||||||
Provision for income taxes |
868 |
812 |
6,705 |
1,542 |
||||||||
Net loss |
$ |
(66,877) |
$ |
(33,962) |
$ |
(198,483) |
$ |
(123,336) |
||||
Net loss per share: |
||||||||||||
Basic and diluted net loss per share |
$ |
(1.27) |
$ |
(0.73) |
$ |
(3.80) |
$ |
(2.86) |
||||
Shares used to compute basic and diluted net loss per share |
52,611 |
46,470 |
52,165 |
43,080 |
||||||||
(1)Amounts include share-based compensation expense as follows: |
||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||
(In thousands) |
2017 |
2016 |
2017 |
2016 |
||||||||
Research and development |
$ |
5,005 |
$ |
4,933 |
$ |
15,023 |
$ |
15,052 |
||||
Selling, general and administrative |
5,680 |
4,962 |
16,329 |
16,077 |
||||||||
Total share-based compensation expense |
$ |
10,685 |
$ |
9,895 |
$ |
31,352 |
$ |
31,129 |
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
September 30, |
December 31, |
||||
2017 |
2016 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
335,001 |
$ |
501,096 |
|
Receivables from collaborative arrangements |
11,547 |
9,076 |
|||
Prepaid taxes |
289 |
3,060 |
|||
Inventories |
15,258 |
12,220 |
|||
Other prepaid and current assets |
5,038 |
3,051 |
|||
Property and equipment, net |
8,618 |
8,460 |
|||
Long-term marketable securities |
99,399 |
91,565 |
|||
Tax receivable |
8,070 |
- |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
2,106 |
9,893 |
|||
Total assets |
$ |
486,159 |
$ |
639,254 |
|
Liabilities and Shareholders' Equity |
|||||
Current liabilities |
48,786 |
49,268 |
|||
Long-term liabilities |
253,256 |
239,755 |
|||
Shareholders' equity |
184,117 |
350,231 |
|||
Total liabilities and shareholders' equity |
$ |
486,159 |
$ |
639,254 |
|
________________________________ |
|||||
(1) |
The condensed consolidated balance sheet at December 31, 2016 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2016. |
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