Theravance Biopharma, Inc. Reports First Quarter 2023 Financial Results and Provides Business Update
- Q1 2023 YUPELRI® (revefenacin) net sales of
$47.0 million , recognized by Viatris, up 8% from Q1 20221 - Q1 2023 YUPELRI retail new patient starts and total prescriptions up 61% and 29%, respectively, year-over-year, reaching all-time highs2
- CYPRESS Phase 3 study of ampreloxetine recruiting; anticipate completing enrollment during H2 2024
- On track to complete
$325 million capital return program by year-end; completed$215 million of share repurchases from inception through4/30/23 Jim Kelly , Managing Director at Weiss Asset Management, joins Board of Directors
"Through the beginning of 2023, we sharpened our commercial and development focus at Theravance, with YUPELRI retail new patient starts growing 61% and achieving a sixth consecutive quarter of record highs. We also delivered an important clinical milestone, having initiated enrollment for CYPRESS, our Phase 3 study for ampreloxetine, since our last update", said Rick E Winningham, Chief Executive Officer. "With the transformation we began nearly two years ago largely completed, we are well positioned to drive an acceleration in YUPELRI performance made possible by its unique value proposition to COPD patients in both the hospital and community settings. We are determined to deliver on this opportunity, while returning substantial capital to shareholders and driving our ampreloxetine study to completion."
"For MSA patients suffering with symptomatic neurogenic orthostatic hypotension (nOH), ampreloxetine has the potential to improve symptoms which impact their quality of life", said
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), achieved
$47.0 million Q1 2023 sales, increasing 8% year-over-year (Q1 2023 vs Q1 2022)1 and increased its share of the long-acting nebulized COPD market to 27.7% throughJanuary 2023 , up from 27.1% in Q4 2022. The PIFR-2 study remains on track for completion during the second half of 2023. - Ampreloxetine, an investigational, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The unique benefits of ampreloxetine treatment reported from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvements, and no signal for supine hypertension. The Company presented findings at three scientific sessions at the 2022
American Autonomic Society meeting.3 Theravance has aligned with the FDA on a new Phase 3 study (CYPRESS) to support a full approval, which was initiated in Q1 2023 and is actively recruiting. $325 Million Return of Capital Program:- Through 3/31/23:
$55 million of share buybacks in Q1 2023 and$183 million since inception inSeptember 2022 throughMarch 2023 . As of 3/31/23, we had$142 million remaining. - Through 4/30/23:
$215 million since inception inSeptember 2022 throughApril 2023 . As of 4/30/23, we had$110 million remaining. - Expect to complete the program by the end of 2023.
- TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD and asthma)
GSK posted first quarter 2023 global net sales of$567 million (up from$454 million , or 25%, from first quarter of 2022).4Theravance Biopharma is entitled to a milestone payment from Royalty Pharma of$50 million if TRELEGY global net sales are equal to or exceed$2.9 billion 5 in 2023, the first of$250 million of potential milestones that can be achieved between 2023 and 2026.
First Quarter Financial Results
- Revenue: Total revenue for the first quarter of 2023 was
$10.4 million , consisting almost entirely of Viatris collaboration revenue. The Viatris collaboration revenue represents amounts receivable from Viatris and comprises 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,Theravance Biopharma's implied 35% share of net sales of YUPELRI for the first quarter of 2023 was$16.4 million which represents an 8% increase compared to the same period in 2022. Viatris collaboration revenue decreased by$0.3 million in the first quarter compared to the same period in 2022 due primarily to timing of higher Viatris costs incurred.
Total revenue for the first quarter represents a$2.8 million decrease compared to the same period in 2022, primarily due to a$2.5 million non-recurring milestone payment received in the first quarter of 2022 related to the Company's licensing arrangement with Pfizer. - Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2023 were
$14.6 million , compared to$23.3 million in the same period in 2022. First quarter R&D expenses included total non-cash share-based compensation of$2.4 million . - Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter of 2023 were
$19.2 million , compared to$17.8 million in the same period in 2022. First quarter SG&A expenses included total non-cash share-based compensation of$4.2 million . - Stock Based Compensation: Share-based compensation expenses for the first quarter of 2023 were
$7.0 million , compared to$14.5 million in the same period in 2022. Excluding restructuring-related expenses, share-based compensation expenses were$6.7 million and$10.0 million for the first quarter of 2023 and 2022, respectively. Share-based compensation expenses consisted of$2.4 million for R&D and$4.2 million for SG&A in the first quarter of 2023, compared to$4.5 million and$5.5 million , respectively, in the same period in 2022. The significant reduction in total share-based compensation expenses was primarily driven by our 2021 restructuring, which was substantially completed in early 2022. - Restructuring Expenses and Related Expenses: Restructuring expenses and related expenses for the first quarter of 2023 were
$1.6 million compared to$9.3 million in the same period in 2022. These expenses primarily comprised severance costs, termination-related benefits, and share-based compensation expense related to the Company's 2023 strategic actions, announced inFebruary 2023 , and the Company's 2021 restructuring announced inSeptember 2021 . Cash restructuring expenses related to the 2023 strategic actions were$1.2 million and non-cash restructuring expenses were$0.4 million in the first quarter of 2023. We do not expect any additional employee-related restructuring expenses, including share-based compensation expenses, after the first quarter of 2023. - Net Loss from Operations and Non-GAAP Net Loss (from continuing operations)6: Net loss from continuing operations was
$22.1 million in the first quarter of 2023 compared to$40.3 million in the same period in 2022, and non-GAAP net loss from continuing operations was$14.9 million in the first quarter of 2023 compared to$25.2 million in the same period in 2022. Non-GAAP net loss from continuing operations consists of GAAP net income (loss) from operations, excluding share-based compensation expense, non-cash interest expense, and income tax expense (benefit). See the section titled "Non-GAAP Financial Measures" for more information. - Cash Position: Cash, cash equivalents and marketable securities totaled
$260.0 million as ofMarch 31, 2023 .
2023 Financial Guidance
- Operating Expenses (excluding share-based compensation and one-time restructuring costs): The Company continues to expect full year 2023 R&D expense of
$35 million to$45 million and SG&A expense of$45 million to$55 million . - The Company reaffirms its expectation that it will generate non-GAAP profit in 2H 2023.6
Conference Call and Live Webcast Today at
A replay of the webcast will be available on
About
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 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.
Non-GAAP Financial Measures
Contact:
investor.relations@theravance.com
650-808-4045
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
|
|
||||
2023 |
2022 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
241,263 |
$ |
327,484 |
|
Receivables from collaborative arrangements |
12,270 |
16,785 |
|||
Prepaid clinical and development services |
1,524 |
1,513 |
|||
Other prepaid and current assets |
6,281 |
7,682 |
|||
Total current assets |
261,338 |
353,464 |
|||
Long-term marketable securities |
18,776 |
- |
|||
Property and equipment, net |
12,103 |
11,875 |
|||
Operating lease assets |
39,204 |
40,126 |
|||
Future contingent milestone and royalty assets |
194,200 |
194,200 |
|||
Restricted cash |
836 |
836 |
|||
Other assets |
12,093 |
6,899 |
|||
Total assets |
$ |
538,550 |
$ |
607,400 |
|
Liabilities and Shareholders' Equity |
|||||
Current liabilities |
$ |
26,184 |
$ |
28,715 |
|
Long-term operating lease liabilities |
43,763 |
45,407 |
|||
Future royalty payment contingency |
25,988 |
25,438 |
|||
Unrecognized tax benefits |
64,191 |
64,191 |
|||
Other long-term liabilities |
7,865 |
1,849 |
|||
Shareholders' equity |
370,559 |
441,800 |
|||
Total liabilities and shareholders' equity |
$ |
538,550 |
$ |
607,400 |
|
________________________________ |
|||||
(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 |
||||||||||||
2023 |
2022 |
|||||||||||
(Unaudited) |
||||||||||||
Revenue: |
||||||||||||
Viatris collaboration agreement (1) |
$ |
10,411 |
$ |
10,687 |
||||||||
Collaboration revenue |
6 |
9 |
||||||||||
Licensing revenue |
- |
2,500 |
||||||||||
Total revenue |
10,417 |
13,196 |
||||||||||
Costs and expenses: |
||||||||||||
Research and development (2) |
14,572 |
23,253 |
||||||||||
Selling, general and administrative (2) |
19,183 |
17,842 |
||||||||||
Restructuring and related expenses (2) |
1,574 |
9,324 |
||||||||||
Total costs and expenses |
35,329 |
50,419 |
||||||||||
Loss from operations |
(24,912) |
(37,223) |
||||||||||
Interest expense |
(550) |
(2,137) |
||||||||||
Interest income and other income (expense), net |
2,979 |
(375) |
||||||||||
Loss from continuing operations before income taxes |
(22,483) |
(39,735) |
||||||||||
Provision for income tax benefit (expense) |
395 |
(524) |
||||||||||
Net loss from continuing operations |
(22,088) |
(40,259) |
||||||||||
Income from discontinued operations before income taxes |
- |
14,313 |
||||||||||
Provision for income tax benefit (expense) |
- |
- |
||||||||||
Net income from discontinued operations |
- |
14,313 |
||||||||||
Net loss |
$ |
(22,088) |
$ |
(25,946) |
||||||||
Net income (loss) per share: |
||||||||||||
Continuing operations - basic and diluted |
$ |
(0.35) |
$ |
(0.53) |
||||||||
Discontinued operations - basic and diluted |
$ |
- |
$ |
0.19 |
||||||||
Net income (loss) - basic and diluted |
$ |
(0.35) |
$ |
(0.34) |
||||||||
Shares used to compute per share calculations - basic and diluted |
62,934 |
75,247 |
||||||||||
Non-GAAP net loss from continuing operations |
(14,912) |
(25,190) |
||||||||||
________________________________ |
||||||||||||
(1) While Viatris, Inc. records the total YUPELRI net sales, the Company is entitled to a 35% share of the net profit (loss) |
||||||||||||
pursuant to a co-promotion agreement with Viatris as presented below: |
||||||||||||
Three Months Ended |
||||||||||||
(In thousands) |
2023 |
2022 |
||||||||||
YUPELRI net sales (100% recorded by Viatris) |
$ |
46,955 |
$ |
43,666 |
||||||||
YUPELRI net sales ( |
16,434 |
15,283 |
||||||||||
(2) Amounts include share-based compensation expense as follows: |
||||||||||||
Three Months Ended |
||||||||||||
(In thousands) |
2023 |
2022 |
||||||||||
Research and development |
$ |
2,441 |
$ |
4,530 |
||||||||
Selling, general and administrative |
4,223 |
5,498 |
||||||||||
Restructuring and related expenses |
357 |
4,517 |
||||||||||
Total share-based compensation expense |
$ |
7,021 |
$ |
14,545 |
THERAVANCE BIOPHARMA, INC. |
||||||
Reconciliation of GAAP to Non-GAAP Net Income from Continuing Operations |
||||||
(In thousands, except per share data) |
||||||
Three Months Ended |
||||||
2023 |
2022 |
|||||
(Unaudited) |
||||||
GAAP Net Loss from Continuing Operations |
$ |
(22,088) |
$ |
(40,259) |
||
Adjustments: |
||||||
Share-based compensation expense |
7,021 |
14,545 |
||||
Non-cash interest expense |
550 |
- |
||||
Income tax expense (benefit) |
(395) |
524 |
||||
Non-GAAP Net Loss from Continuing Operations |
$ |
(14,912) |
$ |
(25,190) |
||
Non-GAAP Net Loss per Share from Continuing Operations |
||||||
Net loss - basic and diluted |
$ |
(0.24) |
$ |
(0.33) |
||
Shares used to compute per share calculations - basic and diluted |
62,934 |
75,247 |
1 In the US, Viatris is leading the commercialization of YUPELRI, and the Company co-promotes the product under a profit and loss sharing arrangement (65% to Viatris; 35% to the Company).
2 Symphony Health METYS Prescription Dashboard.
3
4 Source: GSK-reported
5 The first milestone payment of
6 Non-GAAP profit (loss) consists of GAAP net income (loss) before taxes less share-based compensation expense and non-cash interest expense. See the section titled "Non-GAAP Financial Measures" for more information.
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