Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
"While COVID continues to impact communities around the country and health systems are strained, YUPELRI saw the highest quarter of net sales since its launch," said Rick E Winningham, Chief Executive Officer. "I am proud of our team and their ability to find a way to service the COPD community during this challenging time. YUPELRI once a day dosing is proving increasingly important in helping over-burdened healthcare professionals provide relief to their COPD patients. In addition, GSK's TRELEGY sales reached their highest levels since launch driven by growth in the asthma indication."
"Strong performance by YUPELRI in Q4 and into 2022 will enable us to invest in our inhaled JAK inhibitor respiratory pipeline," continued Winningham. "Through an active business development program, we will continue to unlock value from our non-core asset portfolio throughout 2022. We remain on target to become sustainably cash-flow positive beginning the second half of this year."
Year-end Highlights
- YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), continued to increase market share and achieved year-over-year net sales growth of 13%; its share of the long-acting nebulized COPD market increased to 23.2% through
October 2021 (up from 18.2% inOctober 2020 ).- On
January 10, 2022 , the Company announced the enrollment of the first patient in a Phase 4 study of YUPELRI® (read more about the announcement here).
- On
Economic Interest
- TRELEGY (first once-daily single inhaler triple therapy for COPD and asthma), in which the Company holds an economic interest, posted fourth quarter 2021 global net sales of
$479 million (up from$315 million , in fourth quarter of 2020) achieving quarterly year-over-year sales growth of 52%, and full year 2021 global net sales of$1,674 million (up from$1,058 million , in 2020), achieving year-over-year sales growth of 58%;Theravance Biopharma is entitled to tiered payments equal to approximately 5.5% to 8.5% of TRELEGY global net sales.3
Fourth Quarter and Full Year Financial Results
- Revenue: Total revenue for the fourth quarter of 2021 was
$14.9 million , comprised of non-cash collaboration revenue of$2.8 million primarily attributed to our global collaboration with Janssen and$12.1 million in Viatris collaboration revenue. Total revenue for the fourth quarter represents a$3.8 million decrease over the same period in 2020. Full year 2021 revenue was$55.3 million , comprised of non-cash collaboration revenue of$11.5 million primarily attributed to our global collaboration with Janssen and$43.8 million in Viatris collaboration revenue. - YUPELRI: The Viatris collaboration revenue of
$12.1 million for the fourth quarter represents amounts receivable from Viatris and is comprised of the Company's 35% share of net sales of YUPELRI as well as its proportionate amount of the total shared costs incurred by the two companies. The non-shared YUPELRI costs incurred byTheravance Biopharma are recorded within operating expenses. While Viatris records the total net sales of YUPELRI within its financial statements, our implied 35% share of net sales of YUPELRI for the fourth quarter of 2021 was$15.3 million . - Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 were
$31.2 million , compared to$65.2 million in the same period in 2020. Fourth quarter R&D expenses included total non-cash share-based compensation of$3.4 million . In terms of Financial Guidance, full-year 2021 R&D expenses excluding non-cash share-based compensation and one-time restructuring costs were$168.0 million vs. Guidance of$170 million to$180 million . - Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2021 were
$21.5 million , compared to$30.1 million in the same period in 2020. Fourth quarter SG&A expenses included total non-cash share-based compensation of$5.1 million . In terms of Financial Guidance, full-year 2021 SG&A expenses excluding non-cash share-based compensation and one-time restructuring costs were$71.2 million vs. Guidance of$65 million to$75 million . - Restructuring and Related Expenses: Restructuring expenses for the fourth quarter of 2021 were
$18.4 million and primarily comprised of severance costs, termination-related benefits, one-time retention costs, and share-based compensation expense. Full year 2021 restructuring and related expenses were$20.1 million . Cash restructuring expenses were$9.8 million for the fourth quarter of 2021 and$11.5 million for full-year 2021; non-cash restructuring expenses were$8.6 million for the fourth quarter of 2021 and for the full-year 2021. - Operating Loss: Operating loss for the fourth quarter of 2021 was
$56.2 million compared to$76.5 million in the same period of 2020. Full year 2021 operating loss was$257.8 million , or$195.7 million excluding share-based compensation expense compared to$297.8 million , or$234.8 million excluding share-based compensation expense in 2020. - Cash Position: Cash, cash equivalents and marketable securities totaled
$173.5 million as ofDecember 31, 2021 .
2022 Financial Guidance
- Operating Expenses (excluding share-based compensation and one-time restructuring costs): The Company expects full year 2022 R&D expense of
$45 million to$55 million and SG&A expense of$35 million to$45 million . - The Company expects to be sustainably cash-flow positive beginning 2H 2022.
Conference Call and Live Webcast Today at
A replay of the conference call will be available on
About
In pursuit of its purpose, Theravance Biopharma leverages decades of respiratory expertise to discover and develop transformational medicines that make a difference. These efforts have led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Its respiratory pipeline of internally discovered programs is targeted to address significant patient respiratory needs.
Theravance Biopharma has an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.
For more information, please visit www.theravance.com.
YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris Company. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.
Forward-Looking Statements
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 / 917-214-6603
THERAVANCE BIOPHARMA, INC. |
||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||
(In thousands, except per share data) |
||||||||||||
Three Months Ended |
Year Ended |
|||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||
(Unaudited) |
(Unaudited) |
(1) |
||||||||||
Revenue: |
||||||||||||
Collaboration revenue |
$ |
2,813 |
$ |
7,083 |
$ |
11,463 |
$ |
26,464 |
||||
Licensing revenue |
- |
- |
- |
1,500 |
||||||||
Viatris collaboration agreement |
12,132 |
11,647 |
43,848 |
43,893 |
||||||||
Total revenue |
14,945 |
18,730 |
55,311 |
71,857 |
||||||||
Costs and expenses: |
||||||||||||
Research and development (2) |
31,225 |
65,165 |
193,657 |
260,953 |
||||||||
Selling, general and administrative (2) |
21,516 |
30,055 |
99,296 |
108,661 |
||||||||
Restructuring and related expenses (2) |
18,371 |
- |
20,142 |
- |
||||||||
Total costs and expenses |
71,112 |
95,220 |
313,095 |
369,614 |
||||||||
Loss from operations |
(56,167) |
(76,490) |
(257,784) |
(297,757) |
||||||||
Income from investment in |
35,305 |
20,139 |
103,987 |
68,438 |
||||||||
Interest expense |
(11,662) |
(11,680) |
(46,889) |
(44,585) |
||||||||
Loss on extinguishment of debt |
- |
- |
- |
(15,464) |
||||||||
Interest and other income, net |
338 |
798 |
1,109 |
2,831 |
||||||||
Loss before income taxes |
(32,186) |
(67,233) |
(199,577) |
(286,537) |
||||||||
Provision for income tax benefit |
151 |
8,799 |
151 |
8,520 |
||||||||
Net loss |
$ |
(32,035) |
$ |
(58,434) |
$ |
(199,426) |
$ |
(278,017) |
||||
Net loss per share: |
||||||||||||
Basic and diluted net loss per share |
$ |
(0.43) |
$ |
(0.92) |
$ |
(2.87) |
$ |
(4.46) |
||||
Shares used to compute basic and diluted net loss per share |
73,960 |
63,725 |
69,461 |
62,345 |
||||||||
________________________________ |
||||||||||||
(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) |
2021 |
2020 |
2021 |
2020 |
||||||||
Research and development |
$ |
3,442 |
$ |
7,570 |
$ |
25,634 |
$ |
31,294 |
||||
Selling, general and administrative |
5,113 |
7,981 |
28,065 |
31,682 |
||||||||
Restructuring and related expenses |
8,362 |
- |
8,362 |
- |
||||||||
Total share-based compensation expense |
$ |
16,917 |
$ |
15,551 |
$ |
62,061 |
$ |
62,976 |
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
|
|
||||
2021 |
2020 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
173,465 |
$ |
292,941 |
|
Receivables from collaborative arrangements |
14,065 |
15,868 |
|||
Amounts due from |
43,534 |
53,799 |
|||
Prepaid clinical and development services |
10,245 |
20,374 |
|||
Other prepaid and current assets |
8,561 |
10,359 |
|||
Total current assets |
249,870 |
393,341 |
|||
Property and equipment, net |
13,657 |
16,422 |
|||
Operating lease assets |
39,690 |
43,260 |
|||
Equity in net assets of |
67,537 |
12,750 |
|||
Restricted cash |
836 |
833 |
|||
Other assets |
3,229 |
2,451 |
|||
Total assets |
$ |
374,819 |
$ |
469,057 |
|
Liabilities and Shareholders' Deficit |
|||||
Current liabilities |
$ |
58,587 |
$ |
123,571 |
|
Convertible senior notes due 2023, net |
228,035 |
226,963 |
|||
Non-recourse notes due 2035, net |
371,359 |
372,873 |
|||
Long-term operating lease liabilities |
52,681 |
47,220 |
|||
Other long-term liabilities |
2,730 |
2,181 |
|||
Shareholders' deficit |
(338,573) |
(303,751) |
|||
Total liabilities and shareholders' deficit |
$ |
374,819 |
$ |
469,057 |
|
________________________________ |
|||||
(1) The condensed consolidated balance sheet as of |
1 While Viatris, Inc. ("Viatris") records the total YUPELRI net sales, the Company is entitled to a 35% share of the profits and losses pursuant to a co-promotion agreement with Viatris.
2 As reported by
3 As reported by
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