Theravance Biopharma, Inc. Reports First Quarter 2017 Financial Results and Provides Business Update
Rick E Winningham, Chairman and Chief Executive Officer, commented: "As we progress into mid-2017, we are on track to deliver clinical results at every stage of development through the remainder of this year and into 2018. This unprecedented period for the Company underscores the depth and breadth of our portfolio, the productivity of our internal R&D engine, and our robust business model. In addition, the Closed Triple for COPD represents an important strategic asset and a promising potential source of income for
Pipeline Update
- Phase 3b low peak inspiratory flow rate (PIFR) study initiated with revefenacin (TD-4208), the Company's once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD), partnered with Mylan. Study is designed to support commercialization and will enroll approximately 200 GOLD1 2, 3, and 4 COPD patients with low PIFR, to compare the effects of nebulized revefenacin versus inhaled tiotropium.
- Phase 2a protocol for TD-9855 (dual norepinephrine and serotonin reuptake inhibitor (NSRI)) amended in neurogenic orthostatic hypotension (nOH) study to include a treatment extension of up to 20 weeks of therapy to assess durability of treatment effects in patients, following encouraging treatment responses in the majority of patients tested to date in the study.
- Phase 1 multiple-ascending dose (MAD) study completed in healthy volunteers with TD-1439, the second compound in the neprilysin (NEP) inhibitor program for cardiovascular and renal diseases. Positive study results demonstrated sustained target engagement, low levels of renal elimination and a favorable safety and tolerability profile, in-line with program objectives.
Expected Upcoming Milestones
- TD-1473 (intestinally restricted pan-janus kinase (JAK) inhibitor): Data from the Phase 1b study in patients with ulcerative colitis in mid-2017.
- Velusetrag (5-HT4 agonist; TD-5108): Data from the Phase 2b study in patients with gastroparesis in mid-2017.
- TD-9855 (NSRI): Data from a Phase 2a study in patients with nOH in 2017.
- Revefenacin (TD-4208): Completion of the 12-month Phase 3 safety study in patients with COPD in mid-2017; potential NDA filing in late 2017; completion of the Phase 3b PIFR study in early 2018; potential regulatory approval in the US for COPD in 2018.
- VIBATIV: Televancin Observational Use Registry (TOURTM) data to be published throughout 2017; completion of the Phase 3 registrational bacteremia study in 2018, to be followed by potential sNDA submission in the US for bacteremia.
- Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol)2: Completion of 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 supplementary regulatory submissions for asthma in 2018.
Notes:
1 Global Initiative for Chronic Obstructive Lung Disease guidelines
2 As reported by
First Quarter Financial Results
Revenue
Revenue for the first quarter of 2017 was
Research and Development (R&D) Expenses
R&D expenses for the first quarter of 2017 were
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the first quarter of 2017 were
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
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 | ||||||
2017 |
2016 | |||||
(Unaudited) | ||||||
Revenue: |
||||||
Product sales |
$ |
3,050 |
$ |
3,311 | ||
Revenue from collaborative arrangements |
37 |
15,099 | ||||
Total revenue |
3,087 |
18,410 | ||||
Costs and expenses: |
||||||
Cost of goods sold |
565 |
778 | ||||
Research and development (1) |
40,565 |
35,678 | ||||
Selling, general and administrative (1) |
20,786 |
23,596 | ||||
Total costs and expenses |
61,916 |
60,052 | ||||
Loss from operations |
(58,829) |
(41,642) | ||||
Interest expense |
(2,137) |
- | ||||
Interest and other income |
1,030 |
186 | ||||
Loss before income taxes |
(59,936) |
(41,456) | ||||
Provision for income taxes |
5,383 |
694 | ||||
Net loss |
$ |
(65,319) |
$ |
(42,150) | ||
Net loss per share: |
||||||
Basic and diluted net loss per share |
$ |
(1.27) |
$ |
(1.10) | ||
Shares used to compute basic and diluted net loss per share |
51,617 |
38,326 | ||||
________________________________ |
||||||
(1) Amounts include share-based compensation expense as follows: |
||||||
Three Months Ended | ||||||
(In thousands) |
2017 |
2016 | ||||
Research and development |
$ |
5,101 |
$ |
5,160 | ||
Selling, general and administrative |
5,168 |
6,170 | ||||
Total share-based compensation expense |
$ |
10,269 |
$ |
11,330 | ||
THERAVANCE BIOPHARMA, INC. | |||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
(In thousands) | |||||
|
| ||||
2017 |
2016 | ||||
Assets |
(Unaudited) |
(1) | |||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
392,768 |
$ |
501,096 | |
Receivables from collaborative arrangements |
7,639 |
9,076 | |||
Prepaid taxes |
3,083 |
3,060 | |||
Inventories |
13,215 |
12,220 | |||
Other prepaid and current assets |
4,799 |
3,051 | |||
Property and equipment, net |
8,251 |
8,460 | |||
Long-term marketable securities |
147,885 |
91,565 | |||
Restricted cash |
833 |
833 | |||
Other assets |
9,566 |
9,893 | |||
Total assets |
$ |
588,039 |
$ |
639,254 | |
Liabilities and Shareholders' Equity |
|||||
Current liabilities |
48,984 |
49,268 | |||
Long-term liabilities |
245,109 |
239,755 | |||
Shareholders' equity |
293,946 |
350,231 | |||
Total liabilities and shareholders' equity |
$ |
588,039 |
$ |
639,254 | |
________________________________ | |||||
(1) |
The condensed consolidated balance sheet at |
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