Summary of Theravance Biopharma FY Conference Call Company Overview - **Company**: Theravance Biopharma (NasdaqGM:TBPH) - **Key Product**: Yupelri, generating approximately $50 million annually in operating cash [4][27] - **Financial Position**: The company has no debt and has cleaned up its balance sheet, positioning itself well for upcoming developments [4][34] Key Focus Areas - **Phase 3 Cypress Study**: The primary focus is on the Cypress study, which is expected to read out in Q1 2026. This study is pivotal for the approval of ampraloxetine for treating neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA) patients [4][5][20] - **Previous Studies**: The Redwood study indicated a strong signal in MSA patients, leading to the design of Cypress as an MSA-only study [6][7] Clinical Data and Efficacy - **Redwood Study Results**: The Redwood study showed a 1.6-point change in the OHSA composite score, indicating a clinically meaningful improvement in symptoms associated with nOH [9][10] - **Cypress Study Goals**: The Cypress study aims for at least a one-point change in the composite score, which is considered clinically meaningful [9][10] - **Symptom Improvement**: The Redwood study showed consistent improvement across various symptoms, including dizziness and weakness, which are expected to be replicated in the Cypress study [11][12] Regulatory and Commercial Strategy - **NDA Preparation**: The NDA for ampraloxetine is largely complete, pending positive results from the Cypress study. The company has conducted extensive safety and efficacy evaluations [14][16] - **Payer Discussions**: Initial discussions with payers have been positive, emphasizing the rarity of the condition and the lack of existing chronic treatments [23][24] Yupelri Insights - **Market Strategy**: Theravance co-promotes Yupelri with Viatris, focusing on hospital formularies and ensuring patients are discharged with prescriptions [27][28] - **Patient Retention**: The company is working to improve patient retention on Yupelri through better first-fill processes and partnerships with specialty pharmacies [29][30] - **Clinical Benefits**: Yupelri has shown comparable or superior benefits in managing COPD exacerbations compared to leading competitors [32] Financial Outlook - **Cash Position**: Theravance has a strong financial foundation with $330 million in cash and an additional $175 million in near-term milestones expected over the next 15 months [33][34] - **Investment Potential**: The combination of financial strength, successful commercialization experience, and potential positive outcomes from the Cypress study positions Theravance favorably for future growth [34] Additional Considerations - **Unique Market Position**: The company aims to establish a new standard of care for MSA patients with chronic treatment options, which are currently lacking in the market [20][21] - **KOL Engagement**: A key opinion leader event is scheduled for December 8, 2025, to further discuss commercial strategies and the potential impact of ampraloxetine [24]

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]