Theravance Biopharma, Inc. Reports Second Quarter 2019 Financial Results and Provides Business Update
Rick E Winningham, Chief Executive Officer, commented: "2019 is a critical year of progress that sets the stage for what we believe will be an extraordinary year of data-driven, value-creating milestones in 2020.
"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. Ampreloxetine, our norepinephrine reuptake inhibitor, is advancing in a Phase 3 registrational program in symptomatic nOH. New data from the Phase 2 study of ampreloxetine presented at recent scientific meetings demonstrated consistent and durable improvements in both symptom severity and daily activity performance in patients with nOH treated with ampreloxetine for 20 weeks. These data further support the potential of this therapy to provide patients with greater durability of effect. The Phase 1 study of TD-8236, our lung-selective inhaled pan-JAK inhibitor, in healthy volunteers and asthmatics is ongoing, and we anticipate results in
"The YUPELRI U.S. launch is progressing well in partnership with Mylan and we are pleased by our progress against key performance metrics. Additionally, we were excited to announce the expansion of our development and commercialization agreement with Mylan for nebulized revefenacin to include
"We are well capitalized and enter the second half of the year in a strong position to continue to drive our key programs toward meaningful inflection points. We are proud of our ability to advance a rich pipeline of differentiated assets that can yield a broad line-up of important milestones and catalysts over the next 12 to 18 months as our later-stage trials mature, earlier-stage programs advance to the clinic, and our commercial efforts gain traction. We look forward to the near-term resolution of the dispute with
Program Updates
TD-1473 (gut-selective pan-Janus kinase (JAK) inhibitor):
- Supplemental data from the four-week exploratory Phase 1b study of TD-1473 in patients with ulcerative colitis shared in an oral presentation at Digestive Disease Week (DDW) in
May 2019 - Study designed to measure signals of localized biologic activity, and with little to no systemic exposure or immunosuppression
- Data were positive across a variety of measures, including disease activity, including rectal bleeding and endoscopic improvement, as well as biomarker changes confirming target engagement
- Registrational 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)):
- New 20-week data from the Phase 2 study in patients with neurogenic orthostatic hypotension (nOH) presented at the
International Association of Parkinsonism and Related Disorders (IAPRD) inJune 2019 and in an oral presentation at the 32ndEuropean Neurology Congress (ENC) inJuly 2019 - Consistent and durable improvements in both symptom severity and daily activity performance in patients with nOH were sustained through 20 weeks of ampreloxetine therapy
- Following withdrawal of ampreloxetine treatment, patients' symptom severity and daily activity scores returned to pre-treatment baseline levels
- Ongoing registrational program in symptomatic nOH comprised of two studies:
- Phase 3 4-week treatment study (SEQUOIA), with data expected in 2H 2020
- Phase 3 4-month open label study followed by a 6-week randomized withdrawal phase (REDWOOD) to demonstrate durability of response
TD-8236 (novel, lung-selective inhaled pan-JAK inhibitor for serious respiratory diseases):
- Phase 1 data expected in
September 2019 ; study designed to evaluate safety and provide biomarker data of TD-8236 in healthy volunteers and asthmatic patients- Program goal in asthma is the prevention of exacerbations and the improvement of symptoms in patients uncontrolled by steroids despite compliance
- TD-8236 shown to potently inhibit targeted mediators of Th2-high and Th2-low asthma in human cells in preclinical studies
YUPELRI® (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 COPD
- Launch underway with partner Mylan; continued strong customer acceptance and brand performance across key market metrics; combined sales infrastructures covering the hospital, hospital discharge, and home health settings
- Development and commercialization agreement with Mylan for nebulized revefenacin expanded to include
China and certain adjacent geographies
TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)1:
- Q2 2019 net sales of
$151.4 million ;Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product - Supplemental NDA submitted to
FDA supporting revised labelling for TRELEGY ELLIPTA on reduction in risk of all-cause mortality compared with ANORO ELLIPTA in patients with COPD - Phase 3 CAPTAIN study in asthma met primary endpoint demonstrating statistically significant improvement in lung function compared with RELVAR/BREO; regulatory submissions planned for 2H 2019
- Product now launched in 36 countries, including
Japan ; approval inChina expected in Q4 2019
Notes:
1 As reported by
Second Quarter Financial Results
Revenue
Total revenue for the second quarter of 2019 was
Research and Development (R&D) Expenses
R&D expenses for the second quarter of 2019 were
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the second quarter of 2019 were
Cash,
Cash, cash equivalents and marketable securities, excluding restricted cash, totaled
2019 Financial Guidance
The Company's guidance on operating loss excluding non-cash share-based compensation for the full year of 2019 remains unchanged at
Arbitration Against Innoviva
In
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:
For general corporate:
650-808-4045
investor.relations@theravance.com
For
Profile
gmarose@profileadvisors.com / ckiaie@profileadvisors.com
THERAVANCE BIOPHARMA, INC. |
||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||
(In thousands, except per share data) |
||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||
(Unaudited) |
(Unaudited) |
|||||||||||
Revenue: |
||||||||||||
Product sales |
$ |
- |
$ |
5,361 |
$ |
- |
$ |
9,040 |
||||
Collaboration revenue |
7,650 |
18,115 |
12,988 |
22,755 |
||||||||
Licensing revenue |
18,500 |
- |
18,500 |
- |
||||||||
Total revenue |
26,150 |
23,476 |
31,488 |
31,795 |
||||||||
Costs and expenses: |
||||||||||||
Cost of goods sold |
- |
(1,448) |
- |
(622) |
||||||||
Research and development (1) |
46,399 |
48,621 |
100,217 |
96,386 |
||||||||
Selling, general and administrative (1) |
22,227 |
25,007 |
47,413 |
49,711 |
||||||||
Total costs and expenses |
68,626 |
72,180 |
147,630 |
145,475 |
||||||||
Loss from operations |
(42,476) |
(48,704) |
(116,142) |
(113,680) |
||||||||
Income from investment in TRC, LLC |
8,366 |
1,949 |
14,595 |
2,635 |
||||||||
Interest expense |
(7,901) |
(2,137) |
(15,759) |
(4,274) |
||||||||
Interest and other income, net |
2,374 |
1,284 |
5,169 |
2,768 |
||||||||
Loss before income taxes |
(39,637) |
(47,608) |
(112,137) |
(112,551) |
||||||||
Provision for income tax (expense) benefit |
(201) |
6,790 |
(281) |
6,646 |
||||||||
Net loss |
$ |
(39,838) |
$ |
(40,818) |
$ |
(112,418) |
$ |
(105,905) |
||||
Net loss per share: |
||||||||||||
Basic and diluted net loss per share |
$ |
(0.72) |
$ |
(0.76) |
$ |
(2.04) |
$ |
(1.98) |
||||
Shares used to compute basic and diluted net loss per share |
55,529 |
53,799 |
55,235 |
53,529 |
||||||||
________________________________ |
||||||||||||
(1)Amounts include share-based compensation expense as follows: |
||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||
(In thousands) |
2019 |
2018 |
2019 |
2018 |
||||||||
Research and development |
$ |
5,720 |
$ |
6,904 |
$ |
11,880 |
$ |
13,463 |
||||
Selling, general and administrative |
5,578 |
6,951 |
11,639 |
14,390 |
||||||||
Total share-based compensation expense |
$ |
11,298 |
$ |
13,855 |
$ |
23,519 |
$ |
27,853 |
||||
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
June 30, |
December 31, |
||||
2019 |
2018 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
396,072 |
$ |
505,276 |
|
Receivables from collaborative arrangements |
979 |
10,053 |
|||
Other prepaid and current assets |
28,987 |
17,494 |
|||
Total current assets |
426,038 |
532,823 |
|||
Property and equipment, net |
12,662 |
13,176 |
|||
Long-term marketable securities |
- |
11,869 |
|||
Operating lease assets |
47,831 |
- |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
5,083 |
1,534 |
|||
Total assets |
$ |
492,447 |
$ |
560,235 |
|
Liabilities and Shareholders' Deficit |
|||||
Current liabilities |
$ |
110,136 |
$ |
98,554 |
|
Convertible senior notes due 2023, net |
225,354 |
224,818 |
|||
Non-recourse notes due 2033, net |
217,715 |
229,535 |
|||
Long-term operating lease liabilities |
48,565 |
- |
|||
Other long-term liabilities |
27,901 |
58,917 |
|||
Shareholders' deficit |
(137,224) |
(51,589) |
|||
Total liabilities and shareholders' deficit |
$ |
492,447 |
$ |
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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