Full Press Release Details
DUBLIN,Nov. 10, 2025/PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:TBPH) today reported financial and operational results for the third quarter of 2025.
"Theravance delivered strong results in the third quarter, highlighted by record YUPELRI net sales and the achievement of non-GAAP breakeven, underscoring our commitment to financial and operational discipline," said Rick E Winningham, Chief Executive Officer of Theravance Biopharma. "In parallel, we continue to advance ampreloxetine toward topline results from the pivotal Phase 3 CYPRESS study in the first quarter of 2026. Backed by a strong balance sheet, durable YUPELRI cash flow, and multiple high-value milestones ahead, we approach this important catalyst from a position of strength—ready to deliver results that could transform the standard of care for multiple system atrophy patients and drive lasting value for patients and shareholders."
Operational Highlights:
YUPELRI®(revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long-acting muscarinic antagonist) bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD):
Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA):
TRELEGY
GSK reported third quarter 2025 global net sales of approximately $1.0 billion (up 24% vs. the third quarter of 2024) and year-to-date net sales of approximately $2.9 billion (up 13% vs. 2024 year-to-date):
Disease State Awareness
Third Quarter Financial Results
2025 Financial Guidance
Strategic Review Committee
Conference Call and Live Webcast Today at 5:00 pm EST
Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm EST / 2:00 pm PST / 10:00 pm GMT.To participate in the live call by telephone, please pre-registerhere. Those interested in the live audio webcast of the conference call may access it byclicking hereor visiting theEvents and Presentationspage under the Investors Section onTheravance Biopharma's website.
A replay of the webcast will be available on Theravance Biopharma's website for 30 days through December 10, 2025.
About Ampreloxetine
Ampreloxetine, an investigational, once-daily, selective 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 in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the U.S., the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.
About CYPRESS (Study 0197), a Phase 3 Study
Study 0197 (NCT05696717) has completed enrollment. This is a registrational Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. The Study includes four periods: screening, open label (12-week period, participants will receive a single daily 10 mg dose of ampreloxetine), randomized withdrawal (eight-week period, double-blind, placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine), and a long-term treatment extension. Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that require standing for a short time) and item 3 (activities that require walking for a short time).
About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH)
MSA is a progressive brain disorder that affects movement and balance and disrupts the function of the autonomic nervous system. The autonomic nervous system controls body functions that are mostly involuntary. One of the most frequent autonomic symptoms associated with MSA is a sudden drop in blood pressure upon standing (nOH).8There are approximately 50,000 MSA patients in the US9and 70-90% of MSA patients experience nOH symptoms.10Despite available therapies, many MSA patients remain symptomatic with nOH.11
Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a fall in systolic blood pressure of ⩾20 mm Hg or diastolic blood pressure of ⩾10 mm Hg, within 3 minutes of standing. Severely affected patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain.
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus is to deliverMedicines that Make a Difference®in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI®(revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value.
For more information, please visitwww.theravance.com.
THERAVANCE BIOPHARMA®, THERAVANCE®and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries).
YUPELRI®is a registered trademark of Viatris Specialty LLC. 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. Theravance Biopharma, Inc. (the "Company") intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's expectations regarding its future profitability, expenses and uses of cash, the Company's goals, designs, strategies, plans and objectives, future growth of YUPELRI sales, future milestone or royalty payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, the safety, efficacy or differentiation of our investigational therapy, commercial potential and market opportunity of our investigational therapy, the status of patent infringement litigation initiated by the Company and its partner against certain generic companies in federal district courts, and expectations around the use of OHSA scores as endpoints for clinical trials. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: factors that could increase the Company's cash requirements or expenses beyond its expectations and any factors that could adversely affect its profitability, whether the milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company's shares, and general economic and market conditions. Other risks affecting the Company are in the Company's Form 10-Q filed with the SEC on August 13, 2025, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
Non-GAAP Financial Measures
Theravance Biopharma provides a non-GAAP profitability target and a non-GAAP metric in this press release. Theravance Biopharma believes that the non-GAAP profitability target and non-GAAP net income (loss) provide meaningful information to assist investors in assessing prospects for future performance and actual performance as they provide better metrics for analyzing the performance of its business by excluding items that may not be indicative of core operating results and the Company's cash position. Because non-GAAP financial targets and metrics, such as non-GAAP profitability and non-GAAP net income (loss), are not standardized, it may not be possible to compare these measures with other companies' non-GAAP targets or measures having the same or a similar name. Thus, Theravance Biopharma's non-GAAP measures should be considered in addition to, not as a substitute for, or in isolation from, the Company's actual GAAP results and other targets.
Please see the appendix attached to this press release for a reconciliation of non-GAAP net income (loss) to its corresponding measure, net income (loss). A reconciliation of non-GAAP net income (loss) to its corresponding GAAP measure is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding, and the potential variability of, expenses and other factors in the future.
Contact:[email protected]650-808-4045
| 1 | In the U.S., 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 | Payments from Royalty Pharma (RP) will be triggered if RP receives certain minimum royalty payments from GSK based on TRELEGY global net sales. | ||
| 3 | Source: Viatris Customer Demand (Q3'25). | ||
| 4 | As of 09/30/25, Theravance Biopharma is eligible to receive from Viatris potential global development, regulatory and sales milestone payments (excluding China and adjacent territories) totaling up to $205.0 million in the aggregate; refer to our SEC filings for further information. | ||
| 5 | Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Sept '25. | ||
| 6 | Freeman R, et al. Precision therapy with ampreloxetine for neurogenic orthostatic hypotension in multiple system atrophy. MedRxiv. https://doi.org/10.1101/2025.08.12.25332833. | ||
| 7 | Non-GAAP profit (loss) consists of GAAP net income (loss) before taxes less (i) share-based compensation expense, (ii) non-cash interest expense, (iii) non-cash impairment charges, and (iv) non-recurring revenue and income items. See the section titled "Non-GAAP Financial Measures" for more information. | ||
| 8 | https://medlineplus.gov/genetics/condition/multiple-system-atrophy/ | ||
| 9 | UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K). | ||
| 10 | Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999). | ||
| 11 | Data on file. MSA Natural History Statistics, NYU September 2019. |
| THERAVANCE BIOPHARMA, INC. | |||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
| (In thousands) | |||||
| September 30, | December 31, | ||||
| 2025 | 2024 | ||||
| Assets | (Unaudited) | (1) | |||
| Current assets: | |||||
| Cash and cash equivalents and short-term marketable securities | $ | 329,680 | $ | 88,350 | |
| Receivables from collaborative arrangements | 18,267 | 18,440 | |||
| Receivables from milestone and royalty assets | - | 50,000 | |||
| Other prepaid and current assets | 6,750 | 4,277 | |||
| Total current assets | 354,697 | 161,067 | |||
| Long-term marketable securities | 3,029 | - | |||
| Property and equipment, net | 6,257 | 7,418 | |||
| Operating lease assets | 25,450 | 28,354 | |||
| Future contingent milestone and royalty assets | - | 144,200 | |||
| Restricted cash | 836 | 836 | |||
| Other assets | 25,191 | 12,286 | |||
| Total assets | $ | 415,460 | $ | 354,161 | |
| Liabilities and Shareholders' Equity | |||||
| Income tax payable | $ | 4,074 | $ | 5,853 | |
| Other current liabilities | 33,333 | 26,232 | |||
| Total current liabilities | 37,407 | 32,085 | |||
| Long-term operating lease liabilities | 33,681 | 39,108 | |||
| Future royalty payment contingency | 32,213 | 30,334 | |||
| Unrecognized tax benefits | 79,165 | 75,199 | |||
| Other long-term liabilities | 313 | 1,890 | |||
| Shareholders' equity | 232,681 | 175,545 | |||
| Total liabilities and shareholders' equity | $ | 415,460 | $ | 354,161 | |
| ________________________________ | |||||
| (1)The condensed consolidated balance sheet as of December 31, 2024 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024. |
| THERAVANCE BIOPHARMA, INC. | ||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
| (In thousands, except per share data) | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||
| (Unaudited) | (Unaudited) | |||||||||||
| Revenue: | ||||||||||||
| Viatris collaboration agreement (1) | $ | 19,990 | $ | 16,868 | $ | 54,073 | $ | 45,627 | ||||
| Licensing revenue | - | - | 7,500 | - | ||||||||
| Total revenue | 19,990 | 16,868 | 61,573 | 45,627 | ||||||||
| Costs and expenses: | ||||||||||||
| Research and development (2) | 8,112 | 9,268 | 30,054 | 28,190 | ||||||||
| Selling, general and administrative (2) | 18,333 | 16,875 | 55,132 | 50,673 | ||||||||
| Impairment of long-lived assets (non-cash) | - | 1,562 | - | 4,513 | ||||||||
| Total costs and expenses | 26,445 | 27,705 | 85,186 | 83,376 | ||||||||
| Loss from operations | (6,455) | (10,837) | (23,613) | (37,749) | ||||||||
| Net gain on realized contingent milestone and royalty assets | - | - | 75,137 | - | ||||||||
| Interest expense (non-cash) | (573) | (630) | (1,879) | (1,903) | ||||||||
| Interest income and other income, net | 4,139 | 1,415 | 6,534 | 3,977 | ||||||||
| Loss before income taxes | (2,889) | (10,052) | 56,179 | (35,675) | ||||||||
| Provision for income tax benefit (expense) | 6,504 | (2,646) | (11,308) | (5,216) | ||||||||
| Net income (loss) | $ | 3,615 | $ | (12,698) | $ | 44,871 | $ | (40,891) | ||||
| Net income (loss) per share: | ||||||||||||
| Net income (loss) per share - basic | $ | 0.07 | $ | (0.26) | $ | 0.89 | $ | (0.84) | ||||
| Net income (loss) per share - diluted | $ | 0.07 | $ | (0.26) | $ | 0.88 | $ | (0.84) | ||||
| Shares used to compute net income (loss) per share - basis | 50,520 | 49,038 | 50,137 | 48,690 | ||||||||
| Shares used to compute net income (loss) per share - diluted | 51,908 | 49,038 | 50,976 | 48,690 | ||||||||
| Non-GAAP net income (loss) | $ | 2,260 | $ | (2,897) | $ | (10,583) | $ | (13,692) | ||||
| ________________________________ | ||||||||||||
| (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 September 30, | Nine Months Ended September 30, | |||||||||||
| (In thousands) | 2025 | 2024 | 2025 | 2024 | ||||||||
| YUPELRI net sales (100% recorded by Viatris) | $ | 71,363 | $ | 62,189 | $ | 196,037 | $ | 171,945 | ||||
| YUPELRI net sales (Theravance Biopharma implied 35%) | 24,977 | 21,766 | 68,613 | 60,181 | ||||||||
| (2)Amounts include share-based compensation expense as follows: | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| (In thousands) | 2025 | 2024 | 2025 | 2024 | ||||||||
| Research and development | $ | 1,080 | $ | 1,111 | $ | 3,137 | $ | 3,727 | ||||
| Selling, general and administrative | 3,496 | 3,852 | 10,859 | 11,840 | ||||||||
| Total share-based compensation expense | $ | 4,576 | $ | 4,963 | $ | 13,996 | $ | 15,567 |
| THERAVANCE BIOPHARMA, INC. | ||||||||||||
| Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Income (Loss) | ||||||||||||
| (In thousands) | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||
| (Unaudited) | (Unaudited) | |||||||||||
| GAAP net income (loss) | $ | 3,615 | $ | (12,698) | $ | 44,871 | $ | (40,891) | ||||
| Adjustments: | ||||||||||||
| Licensing revenue (1) | - | - | (7,500) | - | ||||||||
| Net gain on realized contingent milestone and royalty assets (1) | - | - | (75,137) | - | ||||||||
| Non-cash impairment expense of long-lived assets (1) | - | 1,562 | - | 4,513 | ||||||||
| Share-based compensation expense | 4,576 | 4,963 | 13,996 | 15,567 | ||||||||
| Non-cash interest expense | 573 | 630 | 1,879 | 1,903 | ||||||||
| Income tax benefit (expense) | (6,504) | 2,646 | 11,308 | 5,216 | ||||||||
| Non-GAAP net income (loss) | $ | 2,260 | $ | (2,897) | $ | (10,583) | $ | (13,692) | ||||
| (1)Non-recurring item |