Theravance Biopharma, Inc. Reports Third Quarter 2016 Financial Results and Provides Business Update
Rick E Winningham, Chairman and Chief Executive Officer, commented: "2016 continues to unfold as an important year for
"We are also excited by the progress of our two early stage programs - TD-1473, our intestinally restricted JAK inhibitor, for which we initiated a Phase 1b study in ulcerative colitis patients, and TD-0714, our potential best-in-class NEP inhibitor which successfully completed a Phase 1 MAD study clearing the way for further development.
"We remained focused on executing our commercial and label expansion strategies for VIBATIV® and are pleased with the data emerging from our TOUR registry study which highlight real-world experience with VIBATIV in a range of difficult-to-treat infections. We believe our pipeline of proprietary and partnered assets and our economic interest in certain respiratory programs being developed by GSK and Innoviva, combined with a strong balance sheet and numerous upcoming milestones, are enabling us to build a strong foundation for developing differentiated therapies and creating meaningful value for shareholders."
Recent Highlights
- Completed Public Offerings: The Company announced the closing of its concurrent public offerings of ordinary shares and convertible senior notes with net proceeds of approximately
$316.2 million (after deducting underwriting discounts and commissions and other estimated transaction expenses), which closed onNovember 2, 2016 . - Revefenacin (TD-4208) Program: Once-Daily Nebulized Long-Acting Muscarinic Antagonist (LAMA) for Chronic Obstructive Pulmonary Disease (COPD):
- Two replicate three-month Phase 3 studies met primary efficacy endpoints demonstrating statistically significant and clinically meaningful improvements in trough lung function of revefenacin after 12 weeks of dosing and was generally well-tolerated at both doses studied.
- 12-month safety study fully enrolled. Data expected in 2017, followed by a planned NDA filing by the end of 2017.
- Intestinally Restricted Pan-Janus Kinase (JAK) Inhibitor Program for Ulcerative Colitis and Other Inflammatory Bowel Diseases:
- TD-1473: Reported positive Phase 1 results of single-ascending and multiple-ascending oral doses that demonstrated the compound to be generally well-tolerated and the achievement of target pharmacokinetic profile. Initiated Phase 1b study in patients with moderate to severe ulcerative colitis; data expected mid-2017.
- TD-3504: Announced a second JAK inhibitor compound, chemically distinct from TD-1473. Designed to release active tofacitinib directly into the intestinal tract. Company plans to initiate a Phase 1b study of TD-3504 in ulcerative colitis patients in the first half of 2017.
Neprilysin (NEP) Inhibitor Program for Cardiovascular and Renal Diseases :- TD-0714: Completed Phase 1 multiple-ascending dose study. Results demonstrated sustained target engagement, low levels of renal elimination and a favorable safety and tolerability profile. Company plans to advance an intravenous formulation into a Phase 1 study in early 2017.
- TD-1439: Announced a second NEP inhibitor compound, structurally distinct from TD-0714. Phase 1 single-ascending and multiple-ascending dose studies underway in healthy volunteers; data expected in first half of 2017.
- VIBATIV® (telavancin):
U.S. net product sales of VIBATIV for the third quarter of 2016 were$3.9 million .- TOUR patient registry study enrolling rapidly with over 600 of 1,000 patients enrolled to date. First TOUR data presented in poster presentations at ID Week highlighting real-world experience with VIBATIV in a range of difficult-to-treat infections.
- Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol):
- In September, GlaxoSmithKline (GSK) and Innoviva reported positive top-line results from the pivotal Phase 3 FULFIL study of the Closed Triple in COPD. Data demonstrated superiority for the Closed Triple as compared to Symbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients.
- In October, GSK stated that
U.S. and EU regulatory filings for COPD are on track to be filed in Q4 2016. - In November, GSK disclosed that it is recruiting patients in a Phase 3 study of the Closed Triple for the treatment of asthma.
- TD-8954 (TAK-954): Upfront payment of
$15.0 million recognized in the third quarter, related to the recently announced collaboration agreement with Takeda.
Expected 2016-2018 Key Milestones
- Closed Triple:
U.S. and EU regulatory filings for COPD by GSK and Innoviva (2016)1 - Closed Triple: Initiation of a Phase 3 study in asthma by GSK and Innoviva (2016)1
- TD-1473 (JAK inhibitor): Complete Phase 1b study in ulcerative colitis patients (2017)
- TD-0714 (NEP inhibitor): Advance IV formulation into Phase 1 clinical study (2017)
- Velusetrag (TD-5108): Complete Phase 2b study in gastroparesis (2017)
- Revefenacin (TD-4208): Complete long-term safety study in COPD and file NDA (2017)
- VIBATIV®: Complete Phase 3 bacteremia study (2018)
Notes: |
1As reported by |
Third Quarter 2016 Financial Results
Revenue
Revenue for the third quarter of 2016 was
Research and Development (R&D) Expenses
R&D expenses for the third quarter of 2016 were
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the third quarter of 2016 were
Cash,
Cash, cash equivalents and marketable securities, excluding restricted cash, totaled
Receivables from Collaborative Arrangements
Certain collaborative arrangements entered into by the Company result in reimbursement of expenses in the quarter after they are incurred. Total receivables from collaborative arrangements totaled
2016 Financial Guidance
We anticipate our operating loss, excluding share-based compensation, will be approximately
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
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, MEDICINES THAT MAKE A DIFFERENCE® 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:
Chief Financial Officer
650-808-4045
investor.relations@theravance.com
THERAVANCE BIOPHARMA, INC. | ||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
(Unaudited) | ||||||||||||
(In thousands, except per share data) | ||||||||||||
Three Months Ended |
Nine Months Ended | |||||||||||
2016 |
2015 |
2016 |
2015 | |||||||||
Revenue: |
||||||||||||
Product sales |
$ |
3,901 |
$ |
2,312 |
$ |
12,571 |
$ |
5,716 | ||||
Revenue from collaborative arrangements |
15,174 |
8,386 |
30,385 |
32,517 | ||||||||
Total revenue |
19,075 |
10,698 |
42,956 |
38,233 | ||||||||
Costs and expenses: |
||||||||||||
Cost of goods sold |
332 |
581 |
1,748 |
1,456 | ||||||||
Research and development (1) |
31,951 |
30,367 |
99,698 |
96,763 | ||||||||
Selling, general and administrative (1) |
20,286 |
22,845 |
64,143 |
66,139 | ||||||||
Total costs and expenses |
52,569 |
53,793 |
165,589 |
164,358 | ||||||||
Loss from operations |
(33,494) |
(43,095) |
(122,633) |
(126,125) | ||||||||
Interest and other income |
344 |
104 |
839 |
518 | ||||||||
Loss before income taxes |
(33,150) |
(42,991) |
(121,794) |
(125,607) | ||||||||
Provision for income taxes |
812 |
4,323 |
1,542 |
11,786 | ||||||||
Net loss |
$ |
(33,962) |
$ |
(47,314) |
$ |
(123,336) |
$ |
(137,393) | ||||
Net loss per share: |
||||||||||||
Basic and diluted net loss per share |
$ |
(0.73) |
$ |
(1.40) |
$ |
(2.86) |
$ |
(4.12) | ||||
Shares used to compute basic and diluted net loss per share |
46,470 |
33,689 |
43,080 |
33,353 | ||||||||
(1)Amounts include share-based compensation expense as follows: |
||||||||||||
Three Months Ended |
Nine Months Ended | |||||||||||
(In thousands) |
2016 |
2015 |
2016 |
2015 | ||||||||
Research and development |
$ |
4,933 |
$ |
6,035 |
$ |
15,052 |
$ |
20,334 | ||||
Selling, general and administrative |
4,962 |
6,216 |
16,077 |
22,205 | ||||||||
Total share-based compensation expense |
$ |
9,895 |
$ |
12,251 |
$ |
31,129 |
$ |
42,539 |
THERAVANCE BIOPHARMA, INC. | |||||
CONSOLIDATED BALANCE SHEETS | |||||
(Unaudited) | |||||
(In thousands) | |||||
|
| ||||
2016 |
2015 | ||||
Assets |
|||||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
230,482 |
$ |
172,434 | |
Receivables from collaborative arrangements (1) |
22,713 |
35,232 | |||
Prepaid taxes |
3,168 |
12,764 | |||
Inventories |
12,480 |
10,005 | |||
Other prepaid and current assets |
5,192 |
7,037 | |||
Property and equipment, net |
8,832 |
9,873 | |||
Long-term marketable securities |
58,769 |
42,860 | |||
Restricted cash |
833 |
833 | |||
Other assets |
13,820 |
9,078 | |||
Total assets |
$ |
356,289 |
$ |
300,116 | |
Liabilities and Shareholders' Equity |
|||||
Current liabilities |
45,410 |
49,470 | |||
Long-term liabilities |
13,006 |
7,581 | |||
Shareholders' equity |
297,873 |
243,065 | |||
Total liabilities and shareholders' equity |
$ |
356,289 |
$ |
300,116 |
_________________________ | |||||
(1) |
Receivables from collaborative arrangements includes |
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