Theravance Biopharma, Inc. Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update
Rick E Winningham, Chairman and Chief Executive Officer, commented: "2019 was a year of achievement for
"As we look ahead, 2020 will be an important year for our Company. We have established a strong capital position, augmented by our partnerships, as well as TRELEGY ELLIPTA royalties and YUPELRI commercialization. We are optimistic about future data readouts, especially our wholly owned programs -- ampreloxetine in nOH and TD-8236 in asthma -- which could both represent new treatment paradigms for patients with debilitating chronic diseases. The combined strengths of our research engine, pipeline, proven development expertise and commercial infrastructure have set the stage for a data- and catalyst-rich 2020 -- a year that we believe can deliver meaningful value for stakeholders."
Corporate Highlights
Partnered with Mylan:
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) - One year post-launch -- continued strong customer acceptance across key market metrics; combined
Theravance Biopharma /Mylan sales infrastructures covering the hospital, hospital discharge, and home health settings- Data as of
October 2019 show that YUPELRI achieved an 86% share of the nebulized LAMA market and a 10.7% share of the long-acting nebulized market (including Durable Medical Equipment)
- Data as of
Partnered with Janssen:
TD-5202 (gut-selective irreversible JAK3 inhibitor for inflammatory intestinal diseases):
- TD-5202 was generally well tolerated as a single oral dose up to 2000 milligrams and as a twice-daily oral dose up to 2000 milligrams total per day given for 10 consecutive days in healthy subjects
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 for late-2020
Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI) for symptomatic nOH):
- Ongoing registrational program in symptomatic neurogenic orthostatic hypertension (nOH) comprised of two studies:
- Phase 3 four-week treatment study (SEQUOIA) to demonstrate efficacy, with data expected in late 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):
- Part C extension portion of the Phase 1 trial assessing additional biomarkers in more severe asthmatics underway with results expected in mid-2020
- Phase 2 lung allergen challenge initiated in 4Q 2019; data expected in mid-2020
TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)2:
- 4Q 2019 net sales of
$221.5 million and full-year 2019 net sales of$661.3 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, including
China - GSK filed sNDA 2Q 2019 for mortality benefit compared with ANORO in COPD and sNDA for use in patients with asthma in 3Q 2019
Notes:
1
2 As reported by
Fourth Quarter and Full Year Financial Results
- Revenue: Revenue for the fourth quarter of 2019 was
$29.5 million , comprised of collaboration revenue of$9.6 million primarily attributed to the upfront payment from Janssen for TD-1473, licensing revenue of$10.0 million related to the upfront payment from Pfizer for rights to our skin-selective pan-JAK inhibitor program, and revenue from the Mylan collaboration agreement of$9.9 million . Revenue for the fourth quarter represents a$13.8 million increase over the same period in 2018. The increase was primarily due to licensing revenue associated with the upfront payment from Pfizer and an increase in revenue from the Mylan collaboration agreement, partially offset by a decrease in product sales which resulted from the sale of VIBATIV® to Cumberland Pharmaceuticals in late-2018. Full-year 2019 revenue was$73.4 million , comprised of collaboration revenue of$31.3 million primarily associated with our global collaboration with Janssen, licensing revenue of$28.5 million related to upfronts from Pfizer and Mylan and revenue from the Mylan collaboration of$13.7 million .
- Research and Development Expenses: Research and Development (R&D) expenses for the fourth quarter of 2019 were
$67.0 million , compared to$52.3 million in the same period in 2018. The increase was primarily due to an increase in employee-related costs and share-based compensation related to long-term retention and incentive awards, plus external-related costs associated with the progression of our key programs. Full-year 2019 R&D expenses were$219.2 million , or$190.3 million excluding non-cash share-based compensation.
- Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2019 were
$33.0 million , compared to$25.5 million in the same period in 2018. The increase was primarily due to an increase in share-based compensation related to long-term retention and incentive awards. Full-year 2019 SG&A expenses were$106.1 million , or$74.6 million excluding non-cash share-based compensation.
- Cash,
Cash Equivalents and Marketable Securities Cash, cash equivalents and marketable securities totaled$285.8 million as ofDecember 31, 2019 .
2020 Financial Guidance
- Operating Expenses: The Company expects full-year 2020 operating loss, excluding share-based compensation, of
$205 million to$225 million . Operating loss guidance does not include:- Royalty income for TRELEGY ELLIPTA which the Company recognizes in its statement of operations as "income from investment in
TRC, LLC ;" or - Potential future business development collaborations
- Royalty income for TRELEGY ELLIPTA which the Company recognizes in its statement of operations as "income from investment in
Note: timing and cost of clinical studies associated with key programs, among other factors, could impact financial guidance.
Additionally, as announced on
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 FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.
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:
Corporate Communications and Investor Relations
917-214-6603
THERAVANCE BIOPHARMA, INC. |
|||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||||||
(In thousands, except per share data) |
|||||||||||||
Three Months Ended |
Year Ended |
||||||||||||
2019 |
2018 |
2019 |
2018 |
||||||||||
Revenue: |
(Unaudited) |
(Unaudited) |
(1) |
||||||||||
Product sales |
$ |
- |
$ |
2,415 |
$ |
- |
$ |
15,304 |
|||||
Collaboration revenue |
9,584 |
10,047 |
31,250 |
41,791 |
|||||||||
Licensing revenue |
10,000 |
- |
28,500 |
- |
|||||||||
Mylan collaboration agreement |
9,915 |
3,275 |
13,664 |
3,275 |
|||||||||
Total revenue |
29,499 |
15,737 |
73,414 |
60,370 |
|||||||||
Costs and expenses: |
|||||||||||||
Cost of goods sold |
- |
632 |
- |
715 |
|||||||||
Research and development (2) |
67,025 |
52,269 |
219,248 |
201,348 |
|||||||||
Selling, general and administrative (2) |
33,046 |
25,457 |
106,081 |
97,058 |
|||||||||
Total costs and expenses |
100,071 |
78,358 |
325,329 |
299,121 |
|||||||||
Loss from operations |
(70,572) |
(62,621) |
(251,915) |
(238,751) |
|||||||||
Income from investment in |
11,913 |
5,428 |
33,705 |
11,182 |
|||||||||
Interest expense |
(8,035) |
(4,071) |
(31,862) |
(10,482) |
|||||||||
Interest and other income, net |
1,137 |
7,822 |
8,395 |
11,966 |
|||||||||
Loss before income taxes |
(65,557) |
(53,442) |
(241,677) |
(226,085) |
|||||||||
Provision for income tax benefit (expense) |
(49) |
3,256 |
5,222 |
10,561 |
|||||||||
Net loss |
$ |
(65,606) |
$ |
(50,186) |
$ |
(236,455) |
$ |
(215,524) |
|||||
Net loss per share: |
|||||||||||||
Basic and diluted net loss per share |
$ |
(1.17) |
$ |
(0.92) |
$ |
(4.25) |
$ |
(3.99) |
|||||
Shares used to compute basic and diluted net loss per share |
56,102 |
54,555 |
55,610 |
53,969 |
|||||||||
________________________________ |
|||||||||||||
(1) The condensed consolidated statement of operations for the year ended |
|||||||||||||
(2) Amounts include share-based compensation expense as follows: |
|||||||||||||
Three Months Ended |
Year Ended |
||||||||||||
(In thousands) |
2019 |
2018 |
2019 |
2018 |
|||||||||
Research and development |
$ |
10,615 |
$ |
5,806 |
$ |
28,953 |
$ |
25,563 |
|||||
Selling, general and administrative |
13,297 |
5,908 |
31,497 |
25,750 |
|||||||||
Total share-based compensation expense |
$ |
23,912 |
$ |
11,714 |
$ |
60,450 |
$ |
51,313 |
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
|
|
||||
2019 |
2018 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
280,831 |
$ |
505,276 |
|
Receivables from collaborative arrangements |
11,996 |
10,053 |
|||
Receivables from licensing arrangements |
10,000 |
- |
|||
Amounts due from |
28,574 |
5,422 |
|||
Other prepaid and current assets |
7,087 |
12,072 |
|||
Total current assets |
338,488 |
532,823 |
|||
Property and equipment, net |
12,644 |
13,176 |
|||
Long-term marketable securities |
4,985 |
11,869 |
|||
Operating lease assets |
46,604 |
- |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
5,272 |
1,534 |
|||
Total assets |
$ |
408,826 |
$ |
560,235 |
|
Liabilities and Shareholders' Deficit |
|||||
Current liabilities |
$ |
111,703 |
$ |
98,554 |
|
Convertible senior notes due 2023, net |
225,890 |
224,818 |
|||
Non-recourse notes due 2033, net |
219,300 |
229,535 |
|||
Long-term operating lease liabilities |
47,725 |
- |
|||
Other long-term liabilities |
28,048 |
58,917 |
|||
Shareholders' deficit |
(223,840) |
(51,589) |
|||
Total liabilities and shareholders' deficit |
$ |
408,826 |
$ |
560,235 |
|
(1) |
The condensed consolidated balance sheet as of |
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