Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update
Rick E Winningham, chairman and chief executive officer, commented: "Following a highly productive 2018, we begin the year with great momentum and continue to make meaningful progress towards our goal of designing more effective and safer medicines to address unmet patient needs. Early in 2018, we entered into a global collaboration with Janssen for TD-1473, our gut-selective pan-JAK inhibitor for inflammatory intestinal diseases, for which we are beginning late-stage clinical trials. In the middle of the year, we showed positive four-week results for ampreloxetine in neurogenic orthostatic hypotension, providing us with the confidence to advance into a registrational Phase 3 program which is now underway. In the latter part of 2018, we and our partner Mylan achieved product approval for YUPELRI in COPD, and formal launch efforts are now underway. We closed out the year with R&D Day where we described our innovative research and development strategy of organ-selective medicines designed to expand the therapeutic index beyond that of conventional therapy and introduced several new research programs. Underpinning the progress of our own business, GSK's TRELEGY ELLIPTA for COPD continues its impressive sales trajectory, and we await the results of the Phase 3 CAPTAIN study in asthma in the first half of 2019.
"We anticipate multiple clinical readouts and milestones over the next several months, including supplemental data presentations at upcoming scientific meetings for TD-1473 in ulcerative colitis and ampreloxetine in nOH, as well as Phase 1 data for TD-8236, and initial commercial metrics for YUPELRI. Following our recently completed note financing tied to our economic interest in TRELEGY ELLIPTA, we enter 2019 with a strong cash balance and are well-positioned to execute against our milestones and continue to deliver value to stakeholders."
Program and Corporate Updates
YUPELRITM (revefenacin) inhalation solution (lung-selective nebulized long-acting muscarinic antagonist (LAMA)):
- First and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
- Formal launch activities underway with partner Mylan; combined sales infrastructures covering the hospital, hospital discharge, and home health settings
TD-1473 (gut-selective pan-Janus kinase (JAK) inhibitor):
- First patients dosed in Phase 2 DIONE induction study in Crohn's disease
- Sites initiated in registrational Phase 2b/3 RHEA induction and maintenance study in ulcerative colitis
- Results from the Phase 1b study of TD-1473 in patients with ulcerative colitis accepted as an oral presentation at Digestive Disease Week (DDW) in
May 2019
Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI)):
- Recently announced initiation of dosing in registrational Phase 3 program in symptomatic neurogenic orthostatic hypotension (nOH)
- Phase 2 study in patients with nOH complete; 5-month data further support previously-announced clinical observations after four weeks of treatment. Detailed study data to be submitted for presentation at mid-year scientific meeting
TD-8236 (novel, lung-selective inhaled pan-JAK inhibitor for serious respiratory diseases):
- Discovery leverages organizational expertise in respiratory diseases and JAK inhibition
- Phase 1 clinical study underway; designed to evaluate safety and provide biomarker data of TD-8236 in healthy volunteers and asthma patients; completion expected in mid-2019
- Multiple JAK-dependent pathways clinically validated in asthma and COPD
- Potentially broad activity with JAK inhibition across a range of respiratory indications and phenotypes
- TD-8236 shown to potently inhibit targeted mediators of Th2-high and Th2-low asthma in human cells in preclinical studies
R&D Day in
- Highlighted our innovative research and development strategy of organ-selective medicines and introduced several new research programs that we plan to advance towards clinical development, each specifically tailored to the organ of interest
TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)1:
- GSK reported fourth quarter 2018 net sales of
$100 million and$207 million for the full year 2018;Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product - Currently available in 26 countries, with additional countries expected over the course of 2019; recent regulatory filings include
Japan andChina - Expanded COPD indication in
Europe for patients not adequately treated with dual bronchodilation, making it the first single inhaler triple therapy indicated for patients with moderate to severe COPD - Completion of Phase 3 CAPTAIN study in asthma patients expected in 1H 2019; if positive, submission of supplemental New Drug Application (sNDA) for TRELEGY ELLIPTA in asthma anticipated in 2H 2019
- Completed a non-dilutive private placement of
$250.0 million in aggregate principal amount of non-recourse notes secured by a portion of the future payments the Company expects to receive related to royalties due on net sales1 of TRELEGY ELLIPTA- 75% share of the payments will be used to satisfy the debt obligations until notes repaid
- Remaining 25% of the payments will be directed to benefit the Company on an ongoing basis
- Proceeds were approximately
$229.0 million net of debt issuance costs and a 5% retention of the notes by the Company
- Strategic infusion of cash in late 2018 with retained economics over TRELEGY ELLIPTA's commercial lifespan; proceeds to support key strategic priorities
VIBATIV® (telavancin): Sale of VIBATIV to
Notes:
1 As reported by
Fourth Quarter and Full Year Financial Results
Revenue
Revenue for the fourth quarter of 2018 was
Research and Development (R&D) Expenses
R&D expenses for the fourth quarter of 2018 were
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the fourth quarter of 2018 were
Cash,
Cash, cash equivalents and marketable securities totaled
2019 Financial Guidance
The Company expects full-year 2019 operating loss, excluding share-based compensation, of
Conference Call and Live Webcast Today at
A replay of the conference call will be available on
About
In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including
We have an economic interest in potential future payments from
For more information, please visit www.theravance.com.
THERAVANCE® and the Cross/Star logo 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:
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, |
|||||||||||
2018 |
2017 |
2018 |
2017 |
|||||||||
(Unaudited) |
(Unaudited) |
(1) |
||||||||||
Revenue: |
||||||||||||
Product sales |
$ |
2,415 |
$ |
4,124 |
$ |
15,304 |
$ |
14,788 |
||||
Collaboration revenue |
10,047 |
391 |
41,791 |
598 |
||||||||
Profit sharing revenue |
3,275 |
- |
3,275 |
- |
||||||||
Total revenue |
15,737 |
4,515 |
60,370 |
15,386 |
||||||||
Costs and expenses: |
||||||||||||
Cost of goods sold |
632 |
3,116 |
715 |
6,030 |
||||||||
Research and development (2) |
52,269 |
51,051 |
201,348 |
173,887 |
||||||||
Selling, general and administrative (2) |
25,457 |
29,524 |
97,058 |
95,592 |
||||||||
Total costs and expenses |
78,358 |
83,691 |
299,121 |
275,509 |
||||||||
Loss from operations |
(62,621) |
(79,176) |
(238,751) |
(260,123) |
||||||||
Income from investment in TRC, LLC |
5,428 |
170 |
11,182 |
170 |
||||||||
Interest expense |
(4,071) |
(2,137) |
(10,482) |
(8,547) |
||||||||
Other-than-temporary impairment loss |
- |
- |
- |
(8,000) |
||||||||
Interest and other income, net |
7,822 |
1,209 |
11,966 |
4,789 |
||||||||
Loss before income taxes |
(53,442) |
(79,934) |
(226,085) |
(271,711) |
||||||||
Provision for income tax benefit (expense) |
3,256 |
(6,988) |
10,561 |
(13,694) |
||||||||
Net loss |
$ |
(50,186) |
$ |
(86,922) |
$ |
(215,524) |
$ |
(285,405) |
||||
Net loss per share: |
||||||||||||
Basic and diluted net loss per share |
$ |
(0.92) |
$ |
(1.64) |
$ |
(3.99) |
$ |
(5.45) |
||||
Shares used to compute basic and diluted net loss per share |
54,555 |
52,908 |
53,969 |
52,352 |
||||||||
________________________________ |
||||||||||||
(1) The condensed consolidated statement of operations for the year ended December 31, 2017 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2017. |
||||||||||||
(2)Amounts include share-based compensation expense as follows: |
||||||||||||
Three Months Ended December 31, |
Year Ended December 31, |
|||||||||||
(In thousands) |
2018 |
2017 |
2018 |
2017 |
||||||||
Research and development |
$ |
5,806 |
$ |
7,668 |
$ |
25,563 |
$ |
22,691 |
||||
Selling, general and administrative |
5,908 |
10,125 |
25,750 |
26,454 |
||||||||
Total share-based compensation expense |
$ |
11,714 |
$ |
17,793 |
$ |
51,313 |
$ |
49,145 |
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
December 31, |
December 31, |
||||
2018 |
2017 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
505,276 |
$ |
348,566 |
|
Receivables from collaborative arrangements |
10,053 |
7,109 |
|||
Other prepaid and current assets |
17,494 |
6,244 |
|||
Inventories |
- |
16,830 |
|||
Total current assets |
532,823 |
378,749 |
|||
Property and equipment, net |
13,176 |
10,157 |
|||
Long-term marketable securities |
11,869 |
41,587 |
|||
Tax receivable |
- |
8,191 |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
1,534 |
1,883 |
|||
Total assets |
$ |
560,235 |
$ |
441,400 |
|
Liabilities and Shareholders' (Deficit) Equity |
|||||
Current liabilities |
$ |
98,554 |
$ |
62,552 |
|
Convertible senior notes due 2023, net |
224,818 |
223,746 |
|||
Non-recourse notes due 2033, net |
229,535 |
- |
|||
Other long-term liabilities |
58,917 |
39,924 |
|||
Shareholders' (deficit) equity |
(51,589) |
115,178 |
|||
Total liabilities and shareholders' (deficit) equity |
$ |
560,235 |
$ |
441,400 |
________________________________ |
|||||
(1) The condensed consolidated balance sheet at December 31, 2017 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2017. |
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