Theravance Biopharma, Inc. Reports First Quarter 2022 Financial Results and Provides Business Update
- Implied 35% share of YUPELRI® (revefenacin) net sales1:
$15.3M Q1 2022 up 19% from Q1 2021 - TRELEGY Q1 2022 global net sales:
$454M , up 33% from Q1 20212 - Results from a Phase 3 study of ampreloxetine showed a benefit in study patients with multiple system atrophy (MSA)
- Restructuring process completed in Q1 2022
"We continue to execute against our business plan, stay disciplined in capital allocation, and 2022 remains on track to become sustainably cash-flow positive by the second half of this year and going forward on an annual basis," said Rick E Winningham, Chief Executive Officer. "Our team's perseverance as demonstrated by YUPELRI's hospital sales performance and continued gain of hospital and community market share creates a strong base for future growth. Considering the benefit that ampreloxetine provided to MSA patients in our Study 0170, we will define a path forward through ongoing discussions with regulators and strategic partners. We plan to continue to unlock value from our pipeline throughout 2022."
- 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 23.5% through
January 2022 , up from 23.2% inOctober 2021 , and net sales increased by 19% year-over-year (Q1 2022 vs Q1 2021).
- 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). Phase 3 results (Study 0170) showed a benefit to MSA patients in the study that was observed in multiple endpoints including Orthostatic Hypotension Symptom Assessment (OHSA) composite, Orthostatic Hypotension Daily Activities Scale (OHDAS) composite, Orthostatic Hypotension Questionnaire (OHQ) composite and OHSA #1. (Read more about the data here).
- TRELEGY (first once-daily single inhaler triple therapy for COPD and asthma), in which the Company holds an economic interest, posted first quarter 2022 global net sales of
$454 million (up from$341 million , 33%, in first quarter of 2021);Theravance Biopharma is entitled to tiered payments equal to approximately 5.5% to 8.5% of TRELEGY global net sales.3
- Revenue: Total revenue for the first quarter of 2022 was
$13.2 million , primarily comprised of licensing revenue of$2.5 million related to a development milestone payment from Pfizer for the first patient dosed in a Phase 1 clinical trial of the skin-selective pan-Janus kinase (JAK) inhibitor program and$10.7 million in Viatris collaboration revenue. Total revenue for the first quarter represents a$1.1 million decrease over the same period in 2021 driven by the completion of the recognition of non-cash Janssen collaboration revenue in 2021, resulting from the planned close-out of the izencitinib program.
- YUPELRI: The Viatris collaboration revenue of
$10.7 million for the first quarter of 2022 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 first quarter of 2022 was$15.3 million , up 19% from the first quarter of 2021. We achieved 19% year-over-year growth in net sales, however, due to accounting guidelines, our Viatris collaboration revenue increased by only 3% due to lower costs incurred byTheravance Biopharma as a result of the corporate restructuring, which improves YUPELRI profitability but lowers Viatris collaboration revenue.
- Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2022 were
$23.3 million , compared to$67.6 million in the same period in 2021. First quarter R&D expenses included total non-cash share-based compensation of$4.5 million .
- Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter of 2022 were
$19.1 million , compared to$30.6 million in the same period in 2021. First quarter SG&A expenses included total non-cash share-based compensation of$5.5 million .
- Restructuring and Related Expenses: Restructuring expenses for the first quarter of 2022 were
$9.3 million and primarily comprised of severance costs, termination-related benefits, one-time retention costs, and share-based compensation expense. Cash restructuring expenses were$4.8 million for the first quarter of 2022; and non-cash restructuring expenses were$4.5 million for the first quarter of 2022.
- Operating Loss: Operating loss for the first quarter of 2022 was
$38.5 million compared to$83.9 million in the same period of 2021.
- Cash Position: Cash, cash equivalents and marketable securities totaled
$147.5 million as ofMarch 31, 2022 .
- 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 and going forward on an annual basis.
A replay of the conference call will be available on
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.
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: Gail B. Cohen
Corporate Communications / 917-214-6603
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 |
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
|
|
||||
2022 |
2021 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
147,516 |
$ |
173,465 |
|
Receivables from collaborative arrangements |
12,277 |
14,065 |
|||
Amounts due from |
35,559 |
43,534 |
|||
Prepaid clinical and development services |
4,742 |
10,245 |
|||
Other prepaid and current assets |
4,542 |
8,561 |
|||
Total current assets |
204,636 |
249,870 |
|||
Property and equipment, net |
13,236 |
13,657 |
|||
Operating lease assets |
39,349 |
39,690 |
|||
Equity in net assets of |
94,108 |
67,537 |
|||
Restricted cash |
836 |
837 |
|||
Other assets |
3,194 |
3,228 |
|||
Total assets |
$ |
355,359 |
$ |
374,819 |
|
Liabilities and Shareholders' Deficit |
|||||
Current liabilities |
$ |
44,201 |
$ |
58,587 |
|
Convertible senior notes due 2023, net |
228,303 |
228,035 |
|||
Non-recourse notes due 2035, net |
384,161 |
371,359 |
|||
Long-term operating lease liabilities |
47,415 |
52,681 |
|||
Other long-term liabilities |
2,729 |
2,730 |
|||
Shareholders' deficit |
(351,450) |
(338,573) |
|||
Total liabilities and shareholders' deficit |
$ |
355,359 |
$ |
374,819 |
|
________________________________ |
|||||
(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 |
||||||
2022 |
2021 |
|||||
(Unaudited) |
||||||
Revenue: |
||||||
Viatris collaboration agreement |
$ |
10,687 |
$ |
10,385 |
||
Collaboration revenue |
9 |
3,872 |
||||
Licensing revenue |
2,500 |
- |
||||
Total revenue |
13,196 |
14,257 |
||||
Costs and expenses: |
||||||
Research and development (1) |
23,253 |
67,599 |
||||
Selling, general and administrative (1) |
19,121 |
30,550 |
||||
Restructuring and related expenses (1) |
9,324 |
- |
||||
Total costs and expenses |
51,698 |
98,149 |
||||
Loss from operations |
(38,502) |
(83,892) |
||||
Income from investment in |
25,110 |
16,547 |
||||
Interest expense |
(11,655) |
(11,873) |
||||
Interest income and other income (expense), net |
(375) |
(234) |
||||
Loss before income taxes |
(25,422) |
(79,452) |
||||
Provision for income tax expense |
(524) |
(227) |
||||
Net loss |
$ |
(25,946) |
$ |
(79,679) |
||
Net loss per share: |
||||||
Basic and diluted net loss per share |
$ |
(0.34) |
$ |
(1.24) |
||
Shares used to compute basic and diluted net loss per share |
75,247 |
64,493 |
||||
________________________________ |
||||||
(1) Amounts include share-based compensation expense as follows: |
||||||
Three Months Ended |
||||||
(In thousands) |
2022 |
2021 |
||||
Research and development |
$ |
4,530 |
$ |
7,921 |
||
Selling, general and administrative |
5,498 |
7,911 |
||||
Restructuring and related expenses |
4,517 |
- |
||||
Total share-based compensation expense |
$ |
14,545 |
$ |
15,832 |
||
View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-inc-reports-first-quarter-2022-financial-results-and-provides-business-update-301541217.html
SOURCE