Theravance Biopharma, Inc. Reports Third Quarter 2019 Financial Results and Provides Business Update
Rick E Winningham, Chief Executive Officer, commented:
"As we approach the end of 2019, a critical year of progress for
"2020 will be an important year for our company in terms of delivering data across all of our key development programs: TD-1473, our gut-selective pan-JAK inhibitor, is moving forward in a Phase 2b/3 study in ulcerative colitis and a Phase 2 study in Crohn's disease, partnered with Janssen; ampreloxetine, our norepinephrine reuptake inhibitor, is advancing in a Phase 3 registrational program in symptomatic neurogenic orthostatic hypotension (nOH); TD-8236, our lung-selective pan-JAK inhibitor for which we reported promising Phase 1 data, is planned to be evaluated in additional asthma trials; and TD-5202, our gut-selective irreversible JAK3 inhibitor for inflammatory intestinal diseases, is advancing in Phase 1.
"Regarding our commercial programs, the YUPELRI® U.S. launch is progressing well in partnership with Mylan and we continue to make headway against key performance metrics. Lastly, we continue to be pleased by the commercial momentum of GSK's TRELEGY ELLIPTA.
"Looking ahead, we expect to achieve important milestones over the next 12 to 18 months as we maintain a strong capital position, advance our promising pipeline, build value through our partnerships and prioritize the commercialization of our innovation."
Program Updates
TD-1473 (gut-selective oral pan-Janus kinase (JAK) inhibitor for inflammatory intestinal diseases):
- Phase 2b/3 induction and maintenance study in ulcerative colitis (RHEA) and Phase 2 induction study in Crohn's disease (DIONE) progressing
- Data from the Phase 2b portion of the ulcerative colitis and Phase 2 Crohn's disease studies planned late-2020
Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI) for symptomatic nOH):
- Supplemental data from a small exploratory Phase 2 study in patients with nOH presented at the
International Parkinson and Movement Disorder Society (MDS) inSeptember 2019 suggest mechanistic association between symptom improvement and increases in circulating norepinephrine levels over four weeks of ampreloxetine therapy - Ongoing registrational program in symptomatic nOH comprised of two studies:
- Phase 3 four-week treatment study (SEQUOIA) to demonstrate efficacy, with data expected in 2H 2020
- Phase 3 four-month open label study followed by a six-week randomized withdrawal phase (REDWOOD) to demonstrate durability of response
TD-8236 (lung-selective inhaled pan-JAK inhibitor for inflammatory lung diseases):
- Positive Phase 1 results in healthy subjects and mild asthmatics reported in
September 2018 ; data demonstrated:- Evidence of biological activity in the lung with minimal systemic exposure, favorable overall safety and tolerability; and
- Preliminary positive FeNO (inhaled nitric oxide) data in patients with mild asthma and elevated FeNO levels at baseline
- Part C extension portion of the Phase 1 trial assessing additional biomarkers in more severe asthmatics underway with results expected in 1H 2020
- Phase 2 lung allergen challenge expected to get underway in 4Q19, with results expected in 2020
TD-5202 (gut-selective irreversible JAK3 inhibitor for inflammatory intestinal diseases):
- Phase 1 study in healthy subjects underway, with results expected in 1H 2020
YUPELRI® (revefenacin) inhalation solution (lung-selective nebulized long-acting muscarinic antagonist (LAMA)):
- First and only once-daily, nebulized bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
- U.S. launch underway with partner Mylan; continued strong customer acceptance across key market metrics; combined sales infrastructures covering the hospital, hospital discharge, and home health settings
TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)1:
- 3Q19 net sales of
$172.8 million ;Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product - Product now launched for COPD in 38 markets; approval in
China expected in 4Q19 - GSK filed supplemental NDA for TRELEGY ELLIPTA use in patients with asthma in
October 2019
Notes:
1 As reported by
Third Quarter Financial Results
Revenue
Total revenue for the third quarter of 2019 was
Research and Development (R&D) Expenses
R&D expenses for the third quarter of 2019 were
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the third quarter of 2019 were
Cash,
Cash, cash equivalents, marketable securities, and restricted cash, totaled
2019 Financial Guidance
The Company has reduced its 2019 full year operating loss guidance to a range of
Arbitration Against Innoviva
As reported in the Company's filings with the
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 September 30, |
Nine Months Ended September 30, |
|||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||
(Unaudited) |
(Unaudited) |
|||||||||||
Revenue: |
||||||||||||
Product sales |
$ |
- |
$ |
3,849 |
$ |
- |
$ |
12,889 |
||||
Collaboration revenue |
8,836 |
8,989 |
21,666 |
31,744 |
||||||||
Licensing revenue |
- |
- |
18,500 |
- |
||||||||
Mylan collaboration agreement |
3,591 |
- |
3,749 |
- |
||||||||
Total revenue |
12,427 |
12,838 |
43,915 |
44,633 |
||||||||
Costs and expenses: |
||||||||||||
Cost of goods sold |
- |
705 |
- |
83 |
||||||||
Research and development (1) |
52,006 |
52,693 |
152,223 |
149,079 |
||||||||
Selling, general and administrative (1) |
25,622 |
21,890 |
73,035 |
71,601 |
||||||||
Total costs and expenses
|
77,628 |
75,288 |
225,258 |
220,763 |
||||||||
Loss from operations |
(65,201) |
(62,450) |
(181,343) |
(176,130) |
||||||||
Income from investment in TRC, LLC |
7,197 |
3,119 |
21,792 |
5,754 |
||||||||
Interest expense |
(8,068) |
(2,137) |
(23,827) |
(6,411) |
||||||||
Interest and other income, net |
2,089 |
1,376 |
7,258 |
4,144 |
||||||||
Loss before income taxes |
(63,983) |
(60,092) |
(176,120) |
(172,643) |
||||||||
Provision for income tax benefit |
5,552 |
659 |
5,271 |
7,305 |
||||||||
Net loss |
$ |
(58,431) |
$ |
(59,433) |
$ |
(170,849) |
$ |
(165,338) |
||||
Net loss per share: |
||||||||||||
Basic and diluted net loss per share |
$ |
(1.05) |
$ |
(1.10) |
$ |
(3.08) |
$ |
(3.07) |
||||
Shares used to compute basic and diluted net loss per share |
55,858 |
54,248 |
55,445 |
53,771 |
||||||||
________________________________ |
||||||||||||
(1)Amounts include share-based compensation expense as follows: |
||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||
(In thousands) |
2019 |
2018 |
2019 |
2018 |
||||||||
Research and development |
$ |
6,458 |
$ |
6,294 |
$ |
18,338 |
$ |
19,757 |
||||
Selling, general and administrative |
6,561 |
5,452 |
18,200 |
19,842 |
||||||||
Total share-based compensation expense |
$ |
13,019 |
$ |
11,746 |
$ |
36,538 |
$ |
39,599 |
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
September 30, |
December 31, |
||||
2019 |
2018 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
319,681 |
$ |
505,276 |
|
Receivables from collaborative arrangements |
4,595 |
10,053 |
|||
Amounts due from TRC, LLC |
16,661 |
5,422 |
|||
Short-term restricted cash |
7,496 |
- |
|||
Other prepaid and current assets |
7,219 |
12,072 |
|||
Total current assets |
355,652 |
532,823 |
|||
Property and equipment, net |
12,189 |
13,176 |
|||
Long-term marketable securities |
24,939 |
11,869 |
|||
Operating lease assets |
46,755 |
- |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
4,969 |
1,534 |
|||
Total assets |
$ |
445,337 |
$ |
560,235 |
|
Liabilities and Shareholders' Deficit |
|||||
Current liabilities |
$ |
108,823 |
$ |
98,554 |
|
Convertible senior notes due 2023, net |
225,622 |
224,818 |
|||
Non-recourse notes due 2033, net |
222,008 |
229,535 |
|||
Long-term operating lease liabilities |
48,620 |
- |
|||
Other long-term liabilities |
23,069 |
58,917 |
|||
Shareholders' deficit |
(182,805) |
(51,589) |
|||
Total liabilities and shareholders' deficit |
$ |
445,337 |
$ |
560,235 |
|
________________________________ |
|||||
(1) |
The condensed consolidated balance sheet as of December 31, 2018 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, 2018. |
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