Theravance Biopharma, Inc. Reports Second Quarter 2017 Financial Results and Provides Business Update
Rick E Winningham, Chairman and Chief Executive Officer, commented: "We are incredibly pleased with our progress to date in 2017, which includes the delivery of meaningful clinical data across a number of our key pipeline programs. We are in an unprecedented period at
Recent Pipeline Updates
- Positive results announced from a 12-month Phase 3 safety study of revefenacin (TD-4208), the Company's once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD), partnered with Mylan.
- Positive results announced in the 5 mg treatment arm of velusetrag (5-HT4 agonist; TD-5108) from a Phase 2b study in patients with gastroparesis.
- Early evidence of localized target engagement announced from first cohort of Phase 1b study of TD-1473 (intestinally restricted pan-Janus kinase (JAK) inhibitor) in patients with ulcerative colitis.
Expected Upcoming Milestones and Events
- Revefenacin (TD-4208): NDA filing anticipated in 4Q 2017; completion of the Phase 3b PIFR study in the first quarter of 2018, designed to support commercialization; potential regulatory approval in the US for COPD in 2018.
- Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol)1: Results from the Phase 3 IMPACT study in 2017; potential regulatory approval in the US and EU for COPD in late 2017; Phase 3 CAPTAIN study completion in asthma patients and potential supplementary regulatory submissions for asthma in 2018.
- VIBATIV: Televancin Observational Use Registry (TOURTM) data to be published throughout remainder of 2017; data from the Phase 3 registrational bacteremia study in 2018 or 2019.
- TD-1473: Data from the remaining cohorts of the Phase 1b study in patients with ulcerative colitis in 2018; targeting initiation of induction and maintenance study in 2018.
- TD-9855 (NSRI): Data from the Phase 2a study in patients with nOH in first half of 2018.
Notes:
1 As reported by
Second Quarter Financial Results
Revenue
Revenue for the second quarter of 2017 was
Research and Development (R&D) Expenses
R&D expenses for the second quarter of 2017 were
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the second quarter of 2017 were
Cash,
Cash, cash equivalents and marketable securities, excluding restricted cash, totaled
2017 Financial Guidance
The Company is revising its guidance for operating loss excluding non-cash share-based compensation for the full-year of 2017 to a range of
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 June 30, |
Six Months Ended June 30, |
|||||||||||
2017 |
2016 |
2017 |
2016 |
|||||||||
(Unaudited) |
(Unaudited) |
|||||||||||
Revenue: |
||||||||||||
Product sales |
$ |
3,474 |
$ |
5,359 |
$ |
6,524 |
$ |
8,670 |
||||
Revenue from collaborative arrangements |
35 |
112 |
72 |
15,211 |
||||||||
Total revenue |
3,509 |
5,471 |
6,596 |
23,881 |
||||||||
Costs and expenses: |
||||||||||||
Cost of goods sold |
1,364 |
638 |
1,929 |
1,416 |
||||||||
Research and development (1) |
42,927 |
32,069 |
83,492 |
67,748 |
||||||||
Selling, general and administrative (1) |
24,339 |
20,261 |
45,125 |
43,857 |
||||||||
Total costs and expenses |
68,630 |
52,968 |
130,546 |
113,021 |
||||||||
Loss from operations |
(65,121) |
(47,497) |
(123,950) |
(89,140) |
||||||||
Interest expense |
(2,137) |
- |
(4,274) |
- |
||||||||
Interest and other income (loss), net |
1,425 |
308 |
2,455 |
495 |
||||||||
Loss before income taxes |
(65,833) |
(47,189) |
(125,769) |
(88,645) |
||||||||
Provision for income taxes |
454 |
36 |
5,837 |
730 |
||||||||
Net loss |
$ |
(66,287) |
$ |
(47,225) |
$ |
(131,606) |
$ |
(89,375) |
||||
Net loss per share: |
||||||||||||
Basic and diluted net loss per share |
$ |
(1.27) |
$ |
(1.06) |
$ |
(2.53) |
$ |
(2.16) |
||||
Shares used to compute basic and diluted net loss per share |
52,255 |
44,407 |
51,938 |
41,366 |
||||||||
(1)Amounts include share-based compensation expense as follows: |
||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||
(In thousands) |
2017 |
2016 |
2017 |
2016 |
||||||||
Research and development |
$ |
4,917 |
$ |
4,959 |
$ |
10,018 |
$ |
10,119 |
||||
Selling, general and administrative |
5,481 |
4,945 |
10,649 |
11,115 |
||||||||
Total share-based compensation expense |
$ |
10,398 |
$ |
9,904 |
$ |
20,667 |
$ |
21,234 |
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
June 30, |
December 31, |
||||
2017 |
2016 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
361,820 |
$ |
501,096 |
|
Receivables from collaborative arrangements |
5,318 |
9,076 |
|||
Prepaid taxes |
242 |
3,060 |
|||
Inventories |
12,126 |
12,220 |
|||
Other prepaid and current assets |
5,376 |
3,051 |
|||
Property and equipment, net |
8,679 |
8,460 |
|||
Long-term marketable securities |
136,445 |
91,565 |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
13,047 |
9,893 |
|||
Total assets |
$ |
543,886 |
$ |
639,254 |
|
Liabilities and Shareholders' Equity |
|||||
Current liabilities |
57,103 |
49,268 |
|||
Long-term liabilities |
245,656 |
239,755 |
|||
Shareholders' equity |
241,127 |
350,231 |
|||
Total liabilities and shareholders' equity |
$ |
543,886 |
$ |
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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