Financial Data and Key Metrics Changes - Theravance Biopharma achieved non-GAAP break-even in Q3 2025, reflecting strong execution and financial discipline [2][18] - The company ended the quarter with approximately $333 million in cash and no debt, indicating a solid financial position [4][18] - Collaboration revenue increased to $20 million, up 19% year-over-year, driven by UPELRI's strong performance [18] Business Line Data and Key Metrics Changes - UPELRI net sales increased 15% year-over-year to $71.4 million, supported by strong demand growth and favorable net pricing [6][18] - UPELRI's profit margins reached record levels, with hospital volume increasing 29% year-over-year [7][9] - The company is on track to achieve a $25 million milestone from Viatris based on UPELRI's year-to-date sales [3][6] Market Data and Key Metrics Changes - UPELRI's share in the long-acting nebulized hospital market reached approximately 21%, a new high since launch [7] - Strong growth trends for Trelegy are expected to lead to a $100 million milestone in 2026 [4][17] Company Strategy and Development Direction - Theravance is focused on advancing the pivotal phase III Cypress trial of ampraloxetine, with top-line results expected in early 2026 [3][15] - The company aims to position ampraloxetine as the first precision therapy for symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy [4][15] - A new disease education campaign for healthcare professionals was launched to raise awareness of neurogenic orthostatic hypotension associated with MSA [5] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of the Cypress study and the potential of ampraloxetine to be a significant value inflection point for the company [3][20] - The company is optimistic about achieving near-term milestones totaling $75 million in Q4 2025 [4][19] - Management highlighted the importance of the upcoming Cypress data readout as a transformational catalyst for the company [20] Other Important Information - The company plans to host a KOL event for investors on December 8 to discuss the unmet medical need for patients with MSA and the potential of ampraloxetine [4][16] - The operational execution of the Cypress study has been aligned with FDA requirements, ensuring adequate powering for the trial [39] Q&A Session Summary Question: How does the company plan to balance returning capital to shareholders with the potential launch of ampraloxetine? - Management emphasized the importance of financial strength and the need to evaluate capital return timing based on the execution of the Cypress study [22][23] Question: Are there any pipeline assets being considered for future development? - Management stated that the current focus is on UPELRI and ampraloxetine, with potential evaluation of other options post-ampraloxetine success [25][27] Question: How does the recently published manuscript inform expectations for the Cypress data? - Management indicated that the publication is important for understanding the minimally clinically important difference needed for the Cypress study [30][33] Question: Can the company share enrollment numbers for the randomized withdrawal portion of the Cypress study? - Management confirmed confidence in enrollment numbers and operational execution, stating that the study is adequately powered [39][40]

Financial Data and Key Metrics Changes - Theravance Biopharma achieved non-GAAP break-even in Q3 2025, reflecting strong execution and financial discipline [3][19] - The company ended the quarter with approximately $333 million in cash and no debt, indicating a robust financial position [4][19] - Collaboration revenue increased to $20 million, up 19% year-over-year, driven by UPELRI's strong operating leverage [19] Business Line Data and Key Metrics Changes - UPELRI net sales increased 15% year-over-year to $71.4 million, supported by strong demand growth and favorable net pricing [6][19] - UPELRI's profit margins reached record levels, with hospital volume increasing 29% year-over-year [8][10] - The company is on track to achieve a $25 million milestone from Viatris based on UPELRI's year-to-date sales performance [3][4] Market Data and Key Metrics Changes - UPELRI's share in the long-acting nebulized hospital market reached approximately 21%, a new launch-to-date high [8] - The strong growth trends for Trelegy are expected to lead to a $100 million milestone in 2026, with GSK reporting $1 billion in sales for the quarter [4][18] Company Strategy and Development Direction - The company is focused on advancing the pivotal phase III Cypress trial of ampraloxetine, with top-line results expected in early 2026 [3][16] - Theravance is committed to raising awareness of neurogenic orthostatic hypotension (NOH) associated with multiple system atrophy (MSA) through a new disease education campaign [5] - The management emphasizes the importance of executing the Cypress study and preparing for the potential launch of ampraloxetine [24][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Cypress data readout, viewing it as a significant milestone for the company [16][21] - The company remains optimistic about the transformational potential of ampraloxetine for patients with MSA-related NOH [4][21] - The management highlighted the importance of financial strength and operational execution in maximizing shareholder value [24][26] Other Important Information - The company plans to host a KOL event for investors on December 8 to discuss the unmet medical need for patients with MSA and the potential of ampraloxetine [4][17] - The company reiterated its expense guidance for 2025, expecting results to remain broadly consistent in Q4 [20] Q&A Session Summary Question: How is the company thinking about returning capital to shareholders while preparing for the launch of ampraloxetine? - Management emphasized the importance of financial strength and the need to evaluate capital return timing based on the execution of the Cypress study [24] Question: Are there any pipeline assets being considered for future opportunities? - Management stated that the focus remains on the success of ampraloxetine and UPELRI, with potential evaluations of other options post-launch [26] Question: How does the recently published manuscript inform expectations for the Cypress data? - The publication is important as it establishes a clinically meaningful difference that the company aims to replicate in the Cypress study [32][34] Question: Can the company share enrollment numbers for the randomized withdrawal portion of the Cypress study? - Management expressed confidence in the operational execution and stated that they believe the study is adequately powered [39][40]