Accessibility StatementSkip Navigation DUBLIN, Nov. 20, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced that it will host a virtual key opinion leader (KOL) investor event on Monday, December 8, 2025 at 10:30 AM ET. To register, click here. The event will feature Horacio Kaufmann, MD (Dysautonomia Center, NYU Langone Health), who will join company management to discuss the unmet medical need for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple sys ...

Accessibility StatementSkip Navigation SOURCE Theravance Biopharma, Inc. 21% DUBLIN, Nov. 19, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced that management will participate in the following investor conferences in December 2025: 8 Annual Evercore Healthcare ConferenceLocation: Coral Gables, FLFormat: Fireside ChatDate: Thursday, December 4, 2025Time: 8:20-8:40 AM ETWebcast Oppenheimer Movers in Rare Disease SummitLocation: New York, NYFormat: Panel Discussion - Elevator Pitc ...

Theravance Biopharma Third Quarter 2025 Financial Results and Business Update November 10, 2025 THERAVANCE BIOPHARMA®, THERAVANCE®, the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). All third-party trademarks used herein are the property of their respective owners. © 2025 Theravance Biopharma. All rights reserved. Forward Looking Statements Examples of such statements include statement ...

Core Insights - Theravance Biopharma reported strong third-quarter results, achieving record net sales for YUPELRI and reaching non-GAAP breakeven, indicating financial and operational discipline [2][4][11] - The company is advancing ampreloxetine towards pivotal Phase 3 CYPRESS study topline results expected in Q1 2026, with a focus on addressing unmet needs in multiple system atrophy patients [2][3][15] Operational Highlights - YUPELRI net sales reached an all-time high of $71.4 million, a 15% increase year-over-year, driven by a 6% growth in customer demand and improved net pricing [4][5] - The open-label portion of the pivotal Phase 3 CYPRESS study for ampreloxetine is complete, with topline results anticipated in Q1 2026 [4][11] - The company plans to host a virtual Key Opinion Leader event on December 8, 2025, to discuss ampreloxetine's potential in treating neurogenic orthostatic hypotension [5][11] Financial Performance - Total revenue for Q3 2025 was $20.0 million, with Viatris collaboration revenue increasing by 19% compared to Q3 2024 [11][31] - R&D expenses for Q3 2025 were $8.1 million, down from $9.3 million in the same period in 2024, while SG&A expenses rose to $18.3 million from $16.9 million [11][31] - Net income for Q3 2025 was $3.6 million, a significant improvement from a net loss of $12.7 million in Q3 2024, aided by a $6.5 million income tax benefit [11][33] Strategic Initiatives - The company is preparing for an expedited NDA submission for ampreloxetine, contingent on supportive data from the ongoing study [5][15] - Theravance Biopharma continues to focus on disciplined capital allocation and returning excess cash to shareholders, with a Strategic Review Committee assessing strategic alternatives [18][20]

Core Viewpoint - Theravance Biopharma is set to present its clinical development program for ampreloxetine, a potential treatment for neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), at the upcoming International Symposium on the Autonomic Nervous System [1][2]. Company Presentations - The company will have one platform presentation and three poster presentations at the symposium, focusing on the efficacy and methodologies related to ampreloxetine [1][2]. - The platform presentation will highlight results from the REDWOOD trial, showcasing durable symptomatic benefits of ampreloxetine in MSA patients [2]. - The three poster presentations will cover topics such as the impact of ampreloxetine on supine hypertension, retention strategies in rare disease clinical trials, and enrollment strategies in a Phase III trial for MSA-related nOH [2]. About Ampreloxetine - Ampreloxetine is an investigational, once-daily norepinephrine reuptake inhibitor aimed at treating symptomatic nOH in MSA patients [2][8]. - The treatment has shown an increase in norepinephrine levels and a favorable impact on blood pressure, with no worsening of supine hypertension reported [2]. - The company has received Orphan Drug Designation for ampreloxetine in the U.S. and plans to file a New Drug Application (NDA) if the ongoing Phase 3 CYPRESS study yields positive results [2]. Phase 3 Studies - The CYPRESS study is a registrational Phase 3 trial evaluating the efficacy and durability of ampreloxetine in MSA patients with symptomatic nOH after 20 weeks of treatment [3]. - The primary endpoint is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [3]. - The REDWOOD study previously indicated that the benefits of ampreloxetine were particularly significant in MSA patients, with a 72% reduction in the odds of treatment failure compared to placebo [5]. Disease Context - Multiple system atrophy (MSA) is a progressive brain disorder affecting movement and balance, with approximately 50,000 patients in the U.S. [6]. - 70-90% of MSA patients experience symptomatic nOH, which is characterized by a significant drop in blood pressure upon standing [6][7]. - Neurogenic orthostatic hypotension (nOH) can lead to debilitating symptoms, including dizziness and fainting, severely impacting patients' quality of life [7].

Core Insights - Theravance Biopharma, Inc. will report its Q3 2025 financial results and provide a business update on November 10, 2025, after market close [1] - A conference call and webcast will be held on the same day at 5:00 pm EST [2] Company Overview - Theravance Biopharma focuses on delivering impactful medicines, leveraging decades of expertise [3] - The company has developed YUPELRI (revefenacin), an FDA-approved inhalation solution for chronic obstructive pulmonary disease (COPD) [3] - Ampreloxetine, a late-stage investigational drug, is being developed for neurogenic orthostatic hypotension in patients with Multiple System Atrophy, potentially becoming a first-in-class therapy [3]

Core Insights - Theravance Biopharma will present new analyses on YUPELRI at the CHEST 2025 annual meeting, highlighting its effectiveness in reducing exacerbations in COPD patients [1][2] Company Overview - Theravance Biopharma focuses on delivering impactful medicines, with YUPELRI (revefenacin) approved for the maintenance treatment of COPD [3] - The company is also developing Ampreloxetine, a potential first-in-class therapy for neurogenic orthostatic hypotension in patients with Multiple System Atrophy [3] Research Findings - A retrospective analysis showed that patients adherent to YUPELRI had significantly fewer exacerbations and lower healthcare costs compared to non-adherent patients [2][6] - Post-hoc analyses from a Phase 3 safety study indicated that YUPELRI's exacerbation profile over one year is at least as effective as tiotropium [2][6] Presentation Details - The presentations at CHEST 2025 include: - "Exacerbation Rates in COPD Patients: A Retrospective Analysis of the Nebulized Once Daily Long-Acting Muscarinic Antagonist Revefenacin in a 52-Week Safety Study" by Edmund J Moran, Ph.D. on October 21, 2025 [2] - "Adherence to Revefenacin Associated with Reductions in Exacerbations and Healthcare Costs Following a COPD-Related Hospitalization" by Grace Leung, MPH on October 21, 2025 [2]

Company Announcement - Theravance Biopharma, Inc. will participate in the H.C. Wainwright 27th Annual Global Investment Conference in New York City on September 9, 2025 [1] - CEO Rick Winningham will engage in a Fireside Chat during the event at 1:30 PM EDT [1] Investor Engagement - Management will host in-person meetings during the conference, and interested investors are encouraged to contact their H.C. Wainwright representative for meeting requests [1] Company Overview - Theravance Biopharma focuses on delivering impactful medicines, with FDA-approved YUPELRI® for chronic obstructive pulmonary disease (COPD) [3] - The company is developing Ampreloxetine, a late-stage investigational therapy for neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), which has the potential to be a first-in-class treatment [3] - Theravance Biopharma is committed to creating and driving shareholder value [3]

Core Insights - Theravance Biopharma has completed enrollment in the pivotal Phase 3 CYPRESS study for ampreloxetine, targeting symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][3][5] - nOH affects approximately 80% of MSA patients, leading to severe symptoms and a lack of effective treatment options [1][8] - The CYPRESS study aims to evaluate the efficacy and safety of ampreloxetine, with topline data expected in Q1 2026 [3][5] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a selective norepinephrine reuptake inhibitor for nOH in MSA patients [4][9] - The company has received Orphan Drug Designation for ampreloxetine in the U.S., highlighting the unmet medical need in this patient population [5][9] Study Details - The CYPRESS study is a global, randomized-withdrawal trial assessing ampreloxetine's impact on nOH symptoms, with a primary endpoint of change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [2][6] - The study includes a 12-week open-label phase followed by an 8-week randomized withdrawal phase [2][6] Market Context - There are approximately 40,000 patients in the U.S. suffering from symptomatic nOH due to MSA, indicating a significant market opportunity for effective treatments [2][5] - Current therapies for nOH often fail to provide lasting relief and have safety concerns, underscoring the need for new solutions like ampreloxetine [2][3]

Financial Data and Key Metrics Changes - The company reported net sales for YUPELRI of approximately $66 million for the quarter, representing a 22% year-over-year increase, marking the highest Q2 results since launch [4][8] - Collaboration revenue grew by 31% year-over-year, driven by YUPELRI's net sales growth, leading to improved brand-level profit margins [22][24] - Non-GAAP losses improved to $4.2 million compared to $6.3 million in the prior year, excluding one-time items [25] Business Line Data and Key Metrics Changes - YUPELRI's hospital channel volume increased by 31% compared to 2024, with a long-acting nebulized market share in hospitals reaching approximately 20% [10][11] - The company completed the $225 million sale of its remaining royalty interest in Trelegy to GSK, significantly strengthening its balance sheet [4][22] - Ampreloxetine's Phase 3 Cyprus trial is nearing completion of enrollment, with expectations to report top-line data approximately six months after [5][28] Market Data and Key Metrics Changes - YUPELRI received approval in China, triggering a $7.5 million milestone payment, with plans for commercialization led by Beatrice [4][11] - GSK reported an all-time high of $1.1 billion in Trelegy sales for Q2, contributing to a year-to-date sales total of approximately $2 billion, an 8% increase year-over-year [22] Company Strategy and Development Direction - The company is focused on enhancing shareholder value through strategic reviews and disciplined capital management [6][28] - Ampreloxetine is positioned as a potential transformative therapy for patients with multiple system atrophy (MSA), with a targeted addressable population of approximately 40,000 patients in the U.S. [21][28] - The company aims to maintain a strong financial position while preparing for the upcoming data readout from the Cyprus study [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the $250 million sales threshold for YUPELRI, which would trigger a $25 million milestone payment [9][10] - The company anticipates a stronger second half of the year compared to previous expectations, creating a solid financial foundation as it approaches the Cyprus data readout [26][28] - Management highlighted the importance of the upcoming Cyprus trial results, which could redefine the standard of care for patients with MSA [28] Other Important Information - The company ended the quarter with approximately $340 million in cash and no debt, indicating strong cash management [6][25] - The company is preparing for NDA readiness in parallel with the Cyprus study, with modules already in advanced stages of drafting [19] Q&A Session Summary Question: What contributed to the improved pull-through for YUPELRI this quarter? - Management attributed the improved pull-through to the shift of volume to specialty pharmacy, which enhances patient support and fulfillment [32][35] Question: What is the outlook for YUPELRI in China and the enrollment trends for Cyprus? - Management noted that Beatrice will lead the commercialization in China, and the enrollment profile for Cyprus is expected to be similar to previous studies [41][42] Question: How will pricing for Ampreloxetine be determined? - Management indicated that while it is early to finalize pricing, analysis of recent rare neuro drug launches suggests an average price around $380,000 per year [47] Question: What are the expectations for SG&A increases associated with Ampreloxetine? - Management expects SG&A to remain stable through the second half of the year, with potential increases post-data readout if results are positive [54][56]