Revefenacin

Definitive agreement to result in one-time $225 million cash payment Theravance Biopharma retains rights to up to $150 million in milestones from Royalty Pharma on Trelegy Ellipta net sales in 2025 and 2026, requiring minimal to no growth over 2024 actuals to be achieved $225 million from royalty transaction announced today, in addition to the $1.1 billion upfront received in 2022, and up to $200 million in milestones (of which $50 million was received in 2025), brings total potential lifetime value from Trelegy Ellipta monetization efforts to $1.525 billion First outcome from Strategic Review Committee's ongoing efforts to maximize shareholder value; Board remains committed to returning excess capital to shareholders DUBLIN, June 2, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that it has entered into a definitive agreement to sell its remaining royalty interest in net sales of Trelegy Ellipta ("Trelegy") to GSK (NYSE: GSK) for $225 million in cash. "Through this agreement with GSK to monetize our outer-year Trelegy royalties, we are translating our long-standing confidence in Trelegy's sustained success into immediate value for Theravance Biopharma shareholders," said Rick E Winningham, CEO of Theravance Biopharma. "Our initial 2022 sale of Trelegy royalty interests generated $1.1 billion in upfront cash, strengthening our balance sheet and enabling us to return significant capital to shareholders. Our decision to retain future Trelegy royalties and potential milestones in the 2022 transaction reflected our confidence in the product's enduring value and commitment to maximize the value of the royalty interest for our shareholders. This latest agreement with GSK, resulting from the ongoing work of the Strategic Review Committee and the company's senior management, further validates this strategy, and comes alongside our continued work to grow YUPELRI and advance ampreloxetine towards potential regulatory approval and launch." Theravance Biopharma's economic interest in Trelegy originates from a 2002 collaboration agreement with GSK, in which Theravance Biopharma's predecessor pooled with GSK its long-acting beta agonist (LABA) assets in exchange for milestones and royalties on LABA-containing combination products subsequently developed and commercialized by GSK, including Trelegy. In 2022, Theravance Biopharma sold its economic interest in the Trelegy royalties to Royalty Pharma in exchange for $1.1 billion upfront and potential sales related milestone payments of up to $250 million in the aggregate, while retaining the right to receive 85% of Trelegy royalties for sales of Trelegy from and after 2029 (ex-U.S.) and 2031 (U.S.) ("Outer Year Royalties"). Under the terms of the agreement announced today, Theravance Biopharma will receive $225 million in cash for the sale of the Outer Year Royalties. The Company retains its right to receive up to $150 million in remaining Trelegy sales related milestones in 2025 and 2026 from Royalty Pharma: $50 million if FY 2025 global net sales reach ~$3.41 billion (approx. -1% vs. 2024) $100 million if FY 2026 global net sales reach ~$3.51 billion (approx. +2% vs. 2024) Theravance Biopharma's financial guidance for 2025 remains unchanged. This transaction represents the first outcome of the ongoing efforts of the Strategic Review Committee (the "Committee") of the Board of Directors. Theravance Biopharma announced on November 12, 2024, that the Board of Directors had formed the Committee, composed entirely of independent directors, to assess all strategic alternatives available to the Company. The Company remains focused on disciplined capital allocation and returning excess cash to shareholders. The Committee will continue to evaluate a range of alternatives to further enhance shareholder value, though there can be no assurance that additional transactions will occur. Advisors Lazard acted as exclusive financial advisor, and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor to Theravance Biopharma. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines 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 visit . 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 Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. TRELEGY and ELLIPTA are registered trademarks of the GSK group of companies. 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 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, potential, and objectives, future growth of YUPELRI sales, future milestone and royalty payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, potential or possible safety, efficacy or differentiation of our investigational therapy, ongoing review activities of the Strategic Review Committee and contingent payments due to the Company from the sale of the Company's Trelegy royalty interests to Royalty Pharma. 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 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 Trelegy 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 Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on May 12, 2025, and other periodic reports filed with the United States Securities Exchange Commission (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. Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

DUBLIN , May 9, 2025 /PRNewswire/ -- Theravance Biopharma , Inc. (" Theravance Biopharma " or the "Company") (NASDAQ: TBPH) today announced presentation of analyses of its previous Phase 3 program evaluating ampreloxetine, an investigational medicine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) at the International MSA Congress , taking place May 9-11 in Boston, Massachusetts . A subgroup analysis selected as a platform presentation focused on patients with Multiple System Atrophy (MSA) in the REDWOOD 0170 study (NCT03829657), an international phase 3, placebo-controlled, double-blind, randomized withdrawal trial, designed to demonstrate clinical worsening in those assigned to placebo. This analysis concluded: Patients with MSA showed clinically meaningful improvement in their nOH symptoms as measured by the OH Symptom Assessment (OHSA) composite score after 16 weeks of open-label treatment with ampreloxetine. After week 6 of randomization, symptoms remained stable in the ampreloxetine group and worsened in the placebo group. Ampreloxetine treatment was associated with an improvement in functional activities, such as standing or walking for a short time, which was lost after withdrawal to placebo. The clinical, cardiovascular and neuroendocrine profile of ampreloxetine showed target engagement of residual peripheral autonomic neurons and a sustained standing blood pressure effect, which is consistent with the profile of a selective norepinephrine reuptake inhibitor. An additional analysis from Study 0169 (NCT03750552) presented at the Congress showed that despite treatment with available nOH medications, patients with MSA had the highest nOH symptom burden on entry, which highlights the substantial unmet need for better nOH therapies in this population. Results from these studies were supportive of the current registrational study in patients with nOH and MSA that is currently ongoing (CYPRESS, NCT05696717). "Patients with MSA often experience severe symptoms and impact to their quality of life due to nOH, and we are motivated to reduce this burden to patients and their caregivers," said Dr. Lucy Norcliffe-Kaufmann , Theravance Biopharma's Executive Director of Clinical Science. "As supported by a clinically-validated measure of patient well-being over 16 to 22 weeks of therapy, these analyses underpin our belief in ampreloxetine's potential to provide durable symptom relief with clinically meaningful outcomes." Presentation information: Ampreloxetine in MSA: A pre-specified subgroup analysis of a phase 3, double-blind, placebo-controlled, randomized withdrawal trial Norcliffe-Kaufmann L , et al. Oral Presentation May 9, 2025 - 9:40 AM EDT Norcliffe-Kaufmann L , et al. Poster #78 May 10, 2025 - 12:00 PM EDT Impact of symptomatic neurogenic orthostatic hypotension on symptom burden and daily functioning in patients with alpha synucleinopathies Iodice V, et al. Poster #29 May 9, 2025 - 11:45 AM EDT Slides presented by Dr. Norcliffe-Kaufmann may be found here in the Presentations section of Theravance Biopharma's website. 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 US, 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) is currently enrolling. 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 the ampreloxetine Phase 3 Program (Study 169 and Study 170) Study 0169 (NCT03750552) was a Phase 3, 4-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ampreloxetine compared to placebo in patients with symptomatic nOH (n=195). Patients from Study 0169 were eligible to enter into Study 0170 (NCT03829657), a Phase 3, multi-center, 22-week study comprising a 16-week open-label period and a 6-week double-blind, placebo-controlled, randomized withdrawal period to evaluate the sustained benefit in efficacy and safety of ampreloxetine in patients with symptomatic nOH. The primary endpoint for Study 0170 of treatment failure at week 6 was defined as a worsening of both Orthostatic Hypotension Symptom Assessment Scale (OHSA) question #1 and Patient Global Impression of Severity (PGI-S) scores by 1.0 point. After Study 0169 did not meet its primary endpoint, the Company took actions to close out the ongoing clinical program including Study 0170. The study was more than 80% enrolled (n=128/154 planned) despite stopping early. The primary endpoint was not statistically significant for the overall population of patients which included patients with Parkinson's disease, pure autonomic failure and MSA (odds ratio=0.6; p-value=0.196). The pre-specified subgroup analysis by disease type suggests the benefit seen in patients receiving ampreloxetine was largely driven by MSA patients (n=40). An odds ratio of 0.28 (95% CI: 0.05, 1.22) was observed in MSA patients indicating a 72% reduction in the odds of treatment failure with ampreloxetine compared to placebo. The benefit to MSA patients was observed in multiple endpoints including OHSA composite, Orthostatic Hypotension Daily Activities Scale (OHDAS) composite, Orthostatic Hypotension Questionnaire (OHQ) composite and OHSA #1 (read more about the data here). 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).[1] There are approximately 50,000 MSA patients in the US[2] and 70-90% of MSA patients experience nOH symptoms.[3] Despite available therapies, many MSA patients remain symptomatic with nOH. 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 deliver Medicines 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 visit www.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 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. Theravance Biopharma 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 goals, designs, strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the Company's goals, designs, strategies, plans, potential, and objectives, the Company's regulatory strategies and timing of clinical studies, potential or possible safety, efficacy or differentiation of our investigational therapy, 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 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: 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, ability to retain key personnel, 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-K filed with the SEC on March 7, 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. Contact: investor.relations@theravance.com650-808-4045 1 https://medlineplus.gov/genetics/condition/multiple-system-atrophy/2 UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K).3 Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999). View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-announces-ampreloxetine-presentations-at-the-international-msa-congress-302451224.html SOURCE Theravance Biopharma, Inc.