Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update
Rick E Winningham, Chairman and Chief Executive Officer, commented: "2018 will be an important year for the Company, as we intensify our focus on our strategic priorities, drive clinical execution, and advance programs from our validated research platform towards clinical development. With Trelegy Ellipta launched in the US and multiple strategic partners secured to complement our internal efforts, we are well positioned to execute on the most important opportunities in our portfolio, including optimizing development of our intestinally restricted JAK inhibitor, TD-1473, with Janssen Biotech; advancing our drug for neurogenic orthostatic hypertension, TD-9855, towards a registrational program; launching our nebulized LAMA revefenacin, if approved, with our partner Mylan; and progressing a new program – an inhaled JAK inhibitor for serious respiratory disease – into the clinic."
Anticipated Near-Term Milestones and Events
- TD-1473 (intestinally restricted pan-Janus kinase (JAK) inhibitor): Initiations of Phase 2b/3 induction and maintenance study in ulcerative colitis and Phase 2 induction study in Crohn's disease in second half of 2018
- TD-9855 (norepinephrine serotonin reuptake inhibitor (NSRI)): Data from exploratory Phase 2a study in patients with symptomatic neurogenic orthostatic hypotension (nOH) at the end of the first half of 2018
- Revefenacin (TD-4208, nebulized long-acting muscarinic antagonist (LAMA)): Potential regulatory approval in the US for chronic obstructive pulmonary disease (COPD), with assigned Prescription Drug User Fee Act (PDUFA) target action date of
November 13, 2018 - Progression of inhaled JAK inhibitor, the next program from our research platform aimed at discovering localized medicines that target diseased tissues without systemic exposure, into first-in-human studies in late 2018 or early 2019
- Trelegy Ellipta (Company entitled to approximately 5.5% to 8.5% of worldwide net sales): Potential label expansion in COPD to include IMPACT study data and completion of Phase 3 CAPTAIN study in asthma patients, both expected in 20181
Program Updates
- Recently announced global collaboration with
Janssen Biotech, Inc. (Janssen) to jointly develop and commercialize TD-1473 in inflammatory intestinal diseases, including ulcerative colitis and Crohn's disease.Theravance Biopharma eligible to receive up to$1 billion in potential payments, including$100 million upfront payment received inFebruary 2018 following execution of the agreement; additionally, companies sharing profits and expenses in the US, andTheravance Biopharma would receive double-digit tiered royalties on ex-US sales - Recently announced acceptance by
US Food and Drug Administration (FDA ) of New Drug Application (NDA) for revefenacin for the treatment of COPD and PDUFA target action date ofNovember 13, 2018 - Completed Phase 3b study of revefenacin, designed to assess nebulized revefenacin versus handheld tiotropium via Handihaler® in improving lung function in COPD patients with suboptimal peak inspiratory flow rate (PIFR)
- Primary endpoint of improvement in lung function in COPD patients with suboptimal PIFR, as measured by trough forced expiratory volume in one second (FEV1) after 4 weeks of treatment
- While numerical improvements for revefenacin over tiotropium were not statistically significant for the primary endpoint, the study provided important insights for the use of the product (if approved) in patients with COPD
- In the pre-specified subgroup of severe and very severe (GOLD 3/4) COPD patients (representing approximately 80% of the patients in the study), revefenacin demonstrated nominally statistically significant and clinically relevant improvements in FEV1 versus tiotropium
- Revefenacin was generally well tolerated and no new safety issues were identified
- Study conducted to support commercialization and is not required for
FDA approval
- Expect to provide an update in the first half of 2018 regarding dialogue with US and EU regulators on Phase 3 requirements for velusetrag (TD-5108; 5-HT4 agonist) program in gastroparesis
- Alfasigma S.p.A. evaluating option under existing collaboration agreement to further develop and potentially commercialize velusetrag in the EU (and certain other markets); opt-in by Alfasigma would result in
$10 million payment to the Company and right to receive certain future milestones and royalties
- Alfasigma S.p.A. evaluating option under existing collaboration agreement to further develop and potentially commercialize velusetrag in the EU (and certain other markets); opt-in by Alfasigma would result in
- Phase 3 bacteremia study of VIBATIV® (telavancin) discontinued following recent interim analysis conducted by independent review committee and company-wide review of investment priorities
- Committee concluded the study is underpowered and therefore unlikely to achieve the primary study objective without a significant increase in study size beyond the planned enrollment of 250 patients
- In light of incremental investment required, Company is closing the study
- No new safety issues identified; all currently enrolled patients allowed to complete dosing
- Data generated from study to be shared with regulators and submitted for future scientific publication
- Trelegy Ellipta launched by GSK in
November 2017 1- Commercial and
Medicare Part D coverage at several top national payers secured since earlyJanuary 2018 1 - Landmark IMPACT data submitted to
FDA andEuropean Medicines Agency (EMA) to support expanded label for Trelegy Ellipta1
- Commercial and
Notes:
1 As reported by
Fourth Quarter and Full Year Financial Results
Revenue
Revenue for the fourth quarter of 2017 was
Research and Development (R&D) Expenses
R&D expenses for the fourth quarter of 2017 were
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the fourth quarter of 2017 were
Cash,
Cash, cash equivalents and marketable securities, excluding restricted cash, totaled
2018 Financial Guidance
The Company anticipates full year 2018 operating loss, excluding share-based compensation, will be in the range of
Conference Call Today at
A replay of the conference call will be available on
About
In our relentless pursuit of this objective, we strive to apply insight and innovation at each stage of our business, including research, development and commercialization, and utilize both internal capabilities and those of partners around the world. Our research efforts are focused in the areas of inflammation and immunology. Our research goal is to design localized medicines that target diseased tissues, without systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing localized medicines for the lungs to treat respiratory disease. The first potential medicine to emerge from our research focus on immunology and localized treatments is an oral, intestinally restricted pan-Janus kinase (JAK) inhibitor, currently in development to treat a range of inflammatory intestinal diseases. Our pipeline of internally discovered product candidates will continue to evolve with the goal of creating transformational medicines to address the significant needs of patients.
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 December 31, |
Year Ended December 31, |
|||||||||||||||
2017 |
2016 |
2017 |
2016 |
|||||||||||||
(Unaudited) |
(Unaudited) |
(1) |
||||||||||||||
Revenue: |
||||||||||||||||
Product sales |
$ |
4,124 |
$ |
5,032 |
$ |
14,788 |
$ |
17,603 |
||||||||
Revenue from collaborative arrangements |
391 |
660 |
598 |
31,045 |
||||||||||||
Total revenue |
4,515 |
5,692 |
15,386 |
48,648 |
||||||||||||
Costs and expenses: |
||||||||||||||||
Cost of goods sold |
3,116 |
1,146 |
6,030 |
2,894 |
||||||||||||
Research and development (2) |
51,051 |
42,014 |
173,887 |
141,712 |
||||||||||||
Selling, general and administrative (2) |
29,524 |
20,366 |
95,592 |
84,509 |
||||||||||||
Total costs and expenses |
83,691 |
63,526 |
275,509 |
229,115 |
||||||||||||
Loss from operations |
(79,176) |
(57,834) |
(260,123) |
(180,467) |
||||||||||||
Interest expense |
(2,137) |
(1,404) |
(8,547) |
(1,404) |
||||||||||||
Other-than-temporary impairment loss |
- |
- |
(8,000) |
- |
||||||||||||
Interest and other income (expense), net |
1,379 |
474 |
4,959 |
1,312 |
||||||||||||
Loss before income taxes |
(79,934) |
(58,764) |
(271,711) |
(180,559) |
||||||||||||
Provision for income taxes |
6,988 |
8,568 |
13,694 |
10,110 |
||||||||||||
Net loss |
(86,922) |
$ |
(67,332) |
$ |
(285,405) |
$ |
(190,669) |
|||||||||
Net loss per share: |
||||||||||||||||
Basic and diluted net loss per share |
$ |
(1.64) |
$ |
(1.36) |
$ |
(5.45) |
$ |
(4.26) |
||||||||
Shares used to compute basic and diluted net loss per share |
52,908 |
49,570 |
52,352 |
44,711 |
||||||||||||
____________________________________ |
||||||||||||||||
(1) |
The condensed consolidated statement of operations for the year ended 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. |
|||||||||||||||
(2) |
Amounts include share-based compensation expense as follows: |
|||||||||||||||
Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||||||
(In thousands) |
2017 |
2016 |
2017 |
2016 |
||||||||||||
Research and development |
$ |
7,668 |
$ |
5,150 |
$ |
22,691 |
$ |
20,202 |
||||||||
Selling, general and administrative |
10,125 |
4,890 |
26,454 |
20,967 |
||||||||||||
Total share-based compensation expense |
$ |
17,793 |
$ |
10,040 |
$ |
49,145 |
$ |
41,169 |
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
December 31, |
|||||
2017 |
2016 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
348,566 |
$ |
501,096 |
|
Receivables from collaborative arrangements |
7,109 |
9,076 |
|||
Prepaid taxes |
291 |
3,060 |
|||
Other prepaid and current assets |
5,953 |
3,051 |
|||
Inventories |
16,830 |
12,220 |
|||
Property and equipment, net |
10,157 |
8,460 |
|||
Long-term marketable securities |
41,587 |
91,565 |
|||
Tax receivable |
8,191 |
- |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
1,883 |
9,893 |
|||
Total assets |
$ |
441,400 |
$ |
639,254 |
|
Liabilities and Shareholders' Equity |
|||||
Current liabilities |
62,552 |
49,268 |
|||
Long-term liabilities |
263,670 |
239,755 |
|||
Shareholders' equity |
115,178 |
350,231 |
|||
Total liabilities and shareholders' equity |
$ |
441,400 |
$ |
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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