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PresentationI'd now like to turn the call over to Rick Winningham, Chief Executive Officer at Theravance Biopharma. Please go ahead, Rick.Good morning and welcome to the Theravance Biopharma KOL event. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the Theravance website following the conclusion of the event.Rick WinninghamCEO & Director Good morning, and thank you for joining us. We're excited to host this KOL event focused on ampreloxetine, a med ...

Theravance Biopharma Conference Call Summary Company Overview - **Company**: Theravance Biopharma - **Focus**: Development of Ampraloxetine for treating neurogenic orthostatic hypotension (NOH) in patients with multiple system atrophy (MSA) [2][4][5] Industry Context - **Target Disease**: Neurogenic orthostatic hypotension (NOH) associated with multiple system atrophy (MSA) - **Patient Population**: Approximately 40,000 MSA patients in the U.S. with NOH [6][44] - **Current Treatment Landscape**: Existing therapies (midodrine, droxidopa) provide only transient relief and are not effective for MSA [46][47] Key Points and Arguments Ampraloxetine Development - **Phase 3 Study**: The pivotal CYPRESS study is nearing completion, with data expected in Q1 2026 [2][5] - **Mechanism of Action**: Ampraloxetine is a selective norepinephrine transporter (NET) inhibitor designed to enhance norepinephrine levels, thereby improving blood pressure and symptoms in NOH patients [31][19] - **Clinical Evidence**: Previous studies indicated that 70% of MSA patients remain symptomatic despite current treatments, highlighting the unmet need [18][46] Financial Position - **Cash Reserves**: Theravance ended the last quarter with $333 million in cash and no debt, achieving cash flow break-even [5] - **Milestones**: Expected near-term milestones of $175 million from existing products (Trelegy and Yupelri) [5] Clinical Trial Insights - **CYPRESS Study Design**: The study incorporates lessons from the previous REDWOOD study, focusing on a randomized withdrawal design to assess treatment effects [32][34] - **Primary Endpoint**: The Orthostatic Hypotension Symptom Assessment (OHSA) composite score is selected as the primary endpoint, reflecting the full spectrum of NOH symptoms [34][38] Market Opportunity - **Commercial Strategy**: Targeting a concentrated patient population with a lean commercial infrastructure, focusing on centers of excellence [44][51] - **Physician Sentiment**: High interest from physicians, with 90% of neurologists likely to prescribe Ampraloxetine if approved [48] - **Pricing Expectations**: Anticipated pricing aligns with other rare disease therapies, potentially around $300,000 annually per patient [57] Regulatory Engagement - **FDA Interactions**: Positive feedback from the FDA regarding the study design and primary endpoint, indicating alignment for a potential NDA submission [38][42] Additional Important Insights - **Safety Profile**: Ampraloxetine has shown an acceptable safety profile with low side effects and no worsening of supine hypertension [40] - **Global Market Potential**: Opportunities exist beyond the U.S. in Europe and Asia, with established relationships in key opinion leader networks [58] Conclusion - **Future Outlook**: If CYPRESS data is positive, Ampraloxetine could become the first tailored treatment for NOH in MSA, addressing a significant unmet medical need and establishing a new standard of care [60]

Financial Status & Milestones - Theravance Biopharma had approximately $333 million in cash with no debt and expects to remain at similar levels in Q4 2025 [7] - The company anticipates $175 million in near-term milestones based on TRELEGY and YUPELRI sales [7] - Theravance Biopharma has a 35% U S profit share with Viatris for YUPELRI, with IP protection into 2039 [7] Ampreloxetine & CYPRESS Trial - Ampreloxetine targets approximately 40,000 underserved patients in the U S with symptomatic nOH due to MSA [7] - The Phase 3 CYPRESS trial completed enrollment in Q3 2025, with topline data expected in Q1 2026 [7] - In a REDWOOD pre-specified MSA subgroup analysis (n=40), the greatest difference was observed in the 6-item OHSA composite score [48, 51] - Approximately 70-80% of patients with MSA will develop nOH in their lifetime, and despite treatment with available pressor agents, 68% remain symptomatic [30] Commercial Opportunity - The U S market includes approximately 40,000 MSA patients with nOH [7, 83, 96] - Only approximately 34% of patients are currently treated, indicating a significant unmet need [84] - The average launch price for chronic neurology therapies is approximately $333,000 [111]

Core Viewpoint - Theravance Biopharma is hosting a virtual key opinion leader investor event to discuss the unmet medical need for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) and the potential of ampreloxetine as a treatment option [1][2][3] Company Overview - Theravance Biopharma focuses on delivering innovative medicines, including the investigational drug ampreloxetine, which is in development for treating symptomatic nOH in MSA patients [9] - The company has previously developed the FDA-approved YUPELRI (revefenacin) inhalation solution for chronic obstructive pulmonary disease (COPD) [9] Event Details - The investor event is scheduled for December 8, 2025, featuring Dr. Horacio Kaufmann from NYU Langone Health, who will discuss the medical need for nOH treatment in MSA patients and review ampreloxetine's potential [1][2] - The event will also provide an overview of the ongoing Phase 3 CYPRESS study of ampreloxetine, including strategic design choices based on positive results from the REDWOOD study [3] Drug Information - Ampreloxetine is a once-daily selective norepinephrine reuptake inhibitor, showing benefits such as increased norepinephrine levels and improved blood pressure in MSA patients [5] - The drug has received Orphan Drug Designation in the U.S. for treating symptomatic nOH in MSA patients, with plans for a New Drug Application (NDA) submission pending supportive results from the CYPRESS study [5] Study Overview - The CYPRESS study (Study 0197) is a Phase 3, multi-center, randomized withdrawal study evaluating the efficacy and durability of ampreloxetine in MSA patients with symptomatic nOH [6] - The primary endpoint is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score after 20 weeks of treatment [6] Disease Context - Multiple system atrophy (MSA) is a progressive brain disorder affecting movement and balance, with approximately 50,000 patients in the U.S., of whom 70-90% experience nOH symptoms [7] - Neurogenic orthostatic hypotension (nOH) is characterized by a significant drop in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [8]

Core Insights - Theravance Biopharma, Inc. will participate in two investor conferences in December 2025, focusing on healthcare and rare diseases [1][2] Group 1: Upcoming Events - The company will present at the 8th Annual Evercore Healthcare Conference on December 4, 2025, in a fireside chat format from 8:20 to 8:40 AM ET [1] - Theravance will also participate in the Oppenheimer Movers in Rare Disease Summit on December 11, 2025, with a panel discussion scheduled from 2:15 to 2:45 PM ET [1] - One-on-one meetings will be available for interested investors during both events [1] Group 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 for neurogenic orthostatic hypotension in patients with Multiple System Atrophy, is being developed as a potential first-in-class therapy [3]

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]