Theravance Biopharma, Inc. Reports Third Quarter 2021 Financial Results and Provides Business Update
"This last month has been about executing on our strategy to create a new
Quarterly 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 its share of the long-acting nebulized COPD market, increasing to 22% in
July 2021 , up from 21% inApril 2021 , and net sales increased by 7% year-over-year (Q3 2021 vs. Q3 2020).- The Company, in collaboration with its partner Viatris, is also initiating a Phase 4 study comparing improvements in lung function in adults with severe to very severe COPD and suboptimal inspiratory flow rate following once-daily treatment with either YUPELRI® (revefenacin) delivered via standard jet nebulizer or tiotropium delivered via a dry powder inhaler (Spiriva® HandiHaler®). This study is aimed at helping to better inform decisions when physicians are designing a personalized COPD treatment plan with patients. Success in this study would capture more of YUPELRI's addressable market and further strengthen its competitive advantage.
- On
September 15, 2021 , the Company announced strategic actions to focus on its respiratory disease portfolio (read more about the actions here). - Ampreloxetine, an investigational,
Theravance Biopharma -discovered, potent, long-acting, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH), reported Phase 3 top-line results (Study 0169 - read more about the data here). - Izencitinib, an orally administered, once-daily, investigational, internally discovered, high affinity, reversible pan-JAK inhibitor which was designed to be gut-selective, reported Phase 2B top-line results (Study 0157 - read more about the data here).
Economic Interest
- TRELEGY (first once-daily single inhaler triple therapy for COPD and asthma), in which the Company holds an economic interest, posted third quarter 2021 global net sales of
$449 million (up from$253 million , 77%, in the third quarter of 2020);Theravance Biopharma is entitled to tiered payments equal to approximately 5.5% to 8.5% of TRELEGY global net sales.3
Upcoming Clinical Milestones
- Izencitinib and ampreloxetine study close out activities to be completed by end of Q1 2022.
- Q1 2022: Izencitinib (gut-selective oral pan-JAK inhibitor for inflammatory intestinal diseases) Phase 2 in Crohn's disease (Study 0173) – top-line results expected in Q1 2022.
- Q1 2022: Ampreloxetine (norepinephrine reuptake inhibitor) Phase 3 for symptomatic neurogenic orthostatic hypotension (Study 0170) – top-line results expected in Q1 2022.
Third Quarter Financial Results
- Revenue: Total revenue for the third quarter of 2021 was
$13.2 million , comprised of non-cash collaboration revenue of$2.8 million primarily attributed to the global collaboration with Janssen and$10.4 million in Viatris collaboration revenue. Total revenue for the third quarter represents a$5.1 million decrease over the same period in 2020 driven by the reduction of non-cash collaboration revenue related to the Janssen collaboration due to the wind down of the izencitinib clinical program. - YUPELRI: The Viatris collaboration revenue of
$10.4 million for the third quarter of 2021 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, the implied 35% share of net sales of YUPELRI for the third quarter of 2021 was$13.8 million , up 7% from Q3 2020. - Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2021 were
$43.7 million , compared to$67.4 million in the same period in 2020. Third quarter R&D expenses included total non-cash share-based compensation of$7.0 million . - Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the third quarter of 2021 were
$21.3 million , compared to$27.5 million in the same period in 2020. Third quarter SG&A expenses included total non-cash share-based compensation of$7.4 million . - Restructuring and Related Expenses: Restructuring expenses for the third quarter of 2021 were
$1.8 million and primarily comprised of severance costs, termination-related benefits, and one-time retention costs. - Operating Loss: Operating loss for the third quarter of 2021 was
$53.6 million compared to$76.6 million in the same period of 2020. - Cash Position: Cash, cash equivalents and marketable securities totaled
$216.2 million as ofSeptember 30, 2021 .
2021 Financial Guidance
- Operating Expenses (excluding share-based compensation): The Company reiterates that it expects full year 2021 R&D expense of
$180 million to$190 million , and SG&A expense of$70 million to$80 million .
Conference Call and Live Webcast Today at
A replay will be available on www.theravance.com for 30 days through
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 BALANCE SHEETS |
|||||
(In thousands) |
|||||
|
|
||||
2021 |
2020 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
216,213 |
$ |
292,941 |
|
Receivables from collaborative arrangements |
14,001 |
15,868 |
|||
Amounts due from |
43,773 |
53,799 |
|||
Prepaid clinical and development services |
13,242 |
20,374 |
|||
Other prepaid and current assets |
9,943 |
10,359 |
|||
Total current assets |
297,172 |
393,341 |
|||
Property and equipment, net |
16,003 |
16,422 |
|||
Operating lease assets |
40,718 |
43,260 |
|||
Equity in net assets of |
45,086 |
12,750 |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
3,297 |
2,451 |
|||
Total assets |
$ |
403,109 |
$ |
469,057 |
|
Liabilities and Shareholders' Deficit |
|||||
Current liabilities |
$ |
66,082 |
$ |
123,571 |
|
Convertible senior notes due 2023, net |
227,767 |
226,963 |
|||
Non-recourse notes due 2035, net |
375,570 |
372,873 |
|||
Long-term operating lease liabilities |
54,353 |
47,220 |
|||
Other long-term liabilities |
2,929 |
2,181 |
|||
Shareholders' deficit |
(323,592) |
(303,751) |
|||
Total liabilities and shareholders' deficit |
$ |
403,109 |
$ |
469,057 |
|
________________________________ |
|||||
(1) The condensed consolidated balance sheet as of |
THERAVANCE BIOPHARMA, INC. |
||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||
(In thousands, except per share data) |
||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||
(Unaudited) |
(Unaudited) |
|||||||||||
Revenue: |
||||||||||||
Collaboration revenue |
$ |
2,797 |
$ |
7,261 |
$ |
8,649 |
$ |
19,381 |
||||
Licensing revenue |
- |
- |
- |
1,500 |
||||||||
Viatris collaboration agreement |
10,397 |
10,996 |
31,716 |
32,246 |
||||||||
Total revenue |
13,194 |
18,257 |
40,365 |
53,127 |
||||||||
Costs and expenses: |
||||||||||||
Research and development (1) |
43,739 |
67,371 |
162,431 |
195,788 |
||||||||
Selling, general and administrative (1) |
21,299 |
27,501 |
77,780 |
78,606 |
||||||||
Restructuring and related expenses |
1,771 |
- |
1,771 |
- |
||||||||
Total costs and expenses |
66,809 |
94,872 |
241,982 |
274,394 |
||||||||
Loss from operations |
(53,615) |
(76,615) |
(201,617) |
(221,267) |
||||||||
Income from investment in |
30,208 |
13,403 |
68,681 |
48,299 |
||||||||
Interest expense |
(11,742) |
(11,573) |
(35,227) |
(32,905) |
||||||||
Loss on extinguishment of debt |
- |
- |
- |
(15,464) |
||||||||
Interest and other income (expense), net |
(166) |
1,235 |
771 |
2,033 |
||||||||
Loss before income taxes |
(35,315) |
(73,550) |
(167,392) |
(219,304) |
||||||||
Provision for income tax benefit (expense) |
7 |
(93) |
- |
(279) |
||||||||
Net loss |
$ |
(35,308) |
$ |
(73,643) |
$ |
(167,392) |
$ |
(219,583) |
||||
Net loss per share: |
||||||||||||
Basic and diluted net loss per share |
$ |
(0.48) |
$ |
(1.16) |
$ |
(2.46) |
$ |
(3.55) |
||||
Shares used to compute basic and diluted net loss per share |
73,574 |
63,303 |
67,945 |
61,881 |
||||||||
________________________________ |
||||||||||||
(1)Amounts include share-based compensation expense as follows: |
||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||
(In thousands) |
2021 |
2020 |
2021 |
2020 |
||||||||
Research and development |
$ |
6,956 |
$ |
7,761 |
$ |
22,192 |
$ |
23,724 |
||||
Selling, general and administrative |
7,414 |
7,803 |
22,951 |
23,701 |
||||||||
Total share-based compensation expense |
$ |
14,370 |
$ |
15,564 |
$ |
45,143 |
$ |
47,425 |
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
3As reported by
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