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]

Core Insights - Theravance Biopharma announced the presentation of analyses from the initial Phase 3 program of ampreloxetine at the International MSA Congress, highlighting its potential to address neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][2] - The ongoing registrational study (CYPRESS) aims to evaluate the efficacy and durability of ampreloxetine in treating symptomatic nOH in MSA patients [4][5] Company Overview - Theravance Biopharma focuses on developing innovative therapies, with ampreloxetine being a late-stage investigational norepinephrine reuptake inhibitor for symptomatic nOH in MSA patients [3][10] - The company has received Orphan Drug Designation for ampreloxetine in the US, indicating its commitment to addressing unmet medical needs in rare diseases [3] Clinical Study Details - The CYPRESS study is a multi-center, randomized withdrawal trial evaluating ampreloxetine's efficacy after 20 weeks of treatment, with the primary endpoint being the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [4] - Previous studies (Study 0169 and Study 0170) assessed the efficacy and safety of ampreloxetine, with Study 0170 showing a significant benefit in MSA patients, indicated by a 72% reduction in treatment failure odds compared to placebo [5][7] Disease Context - Multiple system atrophy (MSA) is a progressive disorder affecting movement and autonomic functions, with approximately 50,000 patients in the US, of which 70-90% experience nOH symptoms [8][9] - Neurogenic orthostatic hypotension (nOH) is characterized by a significant drop in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [9]

Core Insights - Theravance Biopharma is presenting new analyses of the Phase 3 program for ampreloxetine at the upcoming AAN Meeting, highlighting its selective pharmacodynamic profile [1][2] - The ongoing CYPRESS Study 197 aims to confirm the efficacy of ampreloxetine in treating neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][4] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a once-daily norepinephrine reuptake inhibitor for symptomatic nOH in MSA patients [3][9] - The company has received Orphan Drug Designation for ampreloxetine in the U.S. and plans to file a New Drug Application (NDA) if ongoing studies yield positive results [3] Clinical Study Details - The CYPRESS Study 197 is a multi-center, randomized withdrawal study evaluating the efficacy of ampreloxetine after 20 weeks of treatment, with a primary endpoint of change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [4] - Previous studies (Study 169 and Study 170) indicated that while Study 169 did not meet its primary endpoint, a subgroup analysis suggested significant benefits for MSA patients, showing a 72% reduction in treatment failure odds with ampreloxetine [5][6] Disease Context - Multiple system atrophy (MSA) is a progressive disorder affecting movement and autonomic functions, with approximately 50,000 patients in the U.S., and 70-90% experiencing nOH symptoms [7][8] - Neurogenic orthostatic hypotension (nOH) is characterized by significant drops in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [8]