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]

Theravance Biopharma Second Quarter 2025 Financial Results and Business Update August 12, 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 This presentation contains certain "forward-lo ...

Core Viewpoint - Theravance Biopharma has entered into a definitive agreement to sell its remaining royalty interest in Trelegy Ellipta to GSK for $225 million in cash, translating confidence in Trelegy's sustained success into immediate value for shareholders [1][2] Financial Summary - The sale of Outer Year Royalties will provide Theravance Biopharma with $225 million in cash, in addition to the $1.1 billion received from the initial sale of Trelegy royalty interests in 2022, bringing the total potential lifetime value from Trelegy monetization efforts to $1.525 billion [3][6] - The company retains rights to receive up to $150 million in remaining Trelegy sales-related milestones in 2025 and 2026 from Royalty Pharma, with minimal growth required over 2024 actuals to achieve these milestones [3][6] Strategic Review Committee - This transaction is the first outcome of the ongoing efforts of the Strategic Review Committee formed by the Board of Directors to assess strategic alternatives and enhance shareholder value [4] - The Committee will continue to evaluate various alternatives to maximize shareholder value, although there is no assurance that additional transactions will occur [4] Product Development - Theravance Biopharma is focused on growing YUPELRI and advancing ampreloxetine towards potential regulatory approval and launch, indicating a commitment to developing its product pipeline [2][8]

Financial Data and Key Metrics Changes - The total YUPELRI business has shown strong growth, particularly in the hospital channel, recovering well post-COVID pandemic [2][3] - The company has been able to slightly increase pricing, stabilizing it after previous disruptions [12] Business Line Data and Key Metrics Changes - The hospital business for YUPELRI has been growing unit volume at a faster rate, driven by formulary wins and increased sales representative collaboration with Viatris [4][5] - The company is still in the early stages of growth for YUPELRI, indicating significant potential for future expansion [9] Market Data and Key Metrics Changes - The entry of ensifentrine has not significantly impacted the market share of YUPELRI, as it is generally added to existing therapies rather than replacing them [10][11] - The company is focused on optimizing the channel to improve net pricing and overall fulfillment processes [12] Company Strategy and Development Direction - The company is prioritizing the growth of YUPELRI in the hospital setting before considering adding new products to the sales force [14][15] - Ampreloxetine is viewed as a critical asset for future growth, with a focus on efficient commercialization strategies [30][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term potential of YUPELRI and Trelegy, highlighting the challenges of replicating Trelegy's success [33][35] - The company is committed to returning excess capital to shareholders while focusing on the success of YUPELRI and the development of ampreloxetine [38] Other Important Information - The company has a strong cash position with $130 million on the balance sheet and potential milestones from Trelegy and YUPELRI [31] - The development of Ampreloxetine is seen as a unique opportunity to address a significant unmet need in treating MSA patients [19][24] Q&A Session Summary Question: Are you losing patients at the initial script fill or during refills? - Management indicated that they lose patients both at the initial fill and during follow-up with regional pulmonologists [8] Question: How is the enrollment for the Ampreloxetine study progressing? - Management emphasized the importance of selecting the right patients and sites for the study, ensuring quality care throughout the process [26][27] Question: What is the long-term outlook for Trelegy and its royalties? - Management believes that Trelegy will continue to perform well in both asthma and COPD markets, with royalties reverting back to the company in 2029 [35]

YUPELRI Performance and Potential - YUPELRI net sales for Q1 2025 reached $58.3 million, a 6% increase compared to Q1 2024[10, 24] - Hospital doses of YUPELRI increased by 48% in Q1 2025 compared to Q1 2024[10, 20] - Theravance Biopharma receives 35% of US profits from YUPELRI sales due to a co-promotion agreement with Viatris[9, 11, 16, 23, 58] - A $25 million milestone is achievable if US net sales of YUPELRI exceed $250 million, requiring a 5% growth from 2024[24, 57] - Viatris submitted an NDA in China for YUPELRI in June 2024, with a potential $45 million milestone and 14-20% tiered royalties for Theravance Biopharma[24, 57] TRELEGY Milestones and Royalties - 2024 TRELEGY net sales reached $854 million, a 14% year-over-year increase, positioning the company to trigger a $50 million milestone in 2025[10, 27] - Theravance Biopharma could receive up to $150 million in TRELEGY sales milestones in 2025 and 2026[9, 27, 57] - To trigger the first $25 million milestone in 2025, Royalty Pharma needs to receive $260 million or more in royalty payments from GSK, equivalent to $3063 billion in TRELEGY global net sales[9] - Royalties from TRELEGY net sales, ranging from 5.5% to 8.5%, will return to Theravance Biopharma starting July 1, 2029 (ex-US) and January 1, 2031 (US), extending through the mid-2030s[32, 34, 57, 58] Financial Overview - Theravance Biopharma's cash and cash equivalents totaled $130.9 million at the end of Q1 2025, including a $50 million TRELEGY milestone payment received in February 2025, with no debt[10, 50, 57] - Non-GAAP net loss for Q1 2025 was $8.6 million, compared to $4.5 million for Q1 2024[45, 50] - VIATRIS collaboration revenue was $15.4 million in Q1 2025, compared to $14.5 million in Q1 2024[45, 50]

Financial Data and Key Metrics Changes - YUPELRI net sales increased by 6% to just over $58 million, driven by increased demand and favorable pricing [2][4] - Collaboration revenue reported at $15.4 million, up 6% year over year, with YUPELRI brand level cash profitability growing faster than collaboration revenue [16][18] - The company ended the quarter with $131 million in cash and no debt, reflecting a strong financial position [18][24] Business Line Data and Key Metrics Changes - Hospital doses of YUPELRI increased by 48% year on year, achieving record high volume with approximately 316,000 units pulled through the hospital channel [2][7] - GSK reported Trelegy global net sales up 14%, positioning the company to achieve a $50 million milestone from Royalty Pharma in 2025 [4][10] Market Data and Key Metrics Changes - Market research indicates significant future potential for YUPELRI, with additional demand growth expected and a sizable remaining addressable patient population [8] - The company anticipates a decline in clinical trial costs in the second half of the year as the Cyprus study nears completion [19] Company Strategy and Development Direction - The company remains focused on advancing the Sypris trial and optimizing patient enrollment and experience [3] - YUPELRI is positioned as a core growth driver, with strategies in place to improve its financial contribution and achieve key economic milestones [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial prospects of ampreloxetine, with ongoing engagement with payers to ensure understanding of the therapy's role [35][38] - The company reaffirmed its financial guidance metrics and does not anticipate material impacts from potential tariff measures [19][21] Other Important Information - The company is on track to achieve a one-time $25 million milestone if YUPELRI sales reach $250 million in the calendar year [24] - The company is preparing for an expedited NDA submission for ampreloxetine, with significant progress on key modules already completed [16][25] Q&A Session Questions and Answers Question: Status update on ampreloxetine manufacturing and IP - The IP for ampreloxetine is currently in Ireland, with manufacturing of the API outside the U.S. in Taiwan, allowing flexibility in supply adjustments [28] Question: Efforts to increase hospital prescriptions turning into filled chronic prescriptions - The company is focused on ensuring patients receive support through fulfillment programs and follow-up care, emphasizing the importance of local partnerships [29][31] Question: Feedback from payers on ampreloxetine - The company has started engaging with payers to educate them on the disease burden and the role of ampreloxetine, with further discussions expected post-top line data [35][36] Question: Update on YUPELRI Paragraph IV filers - The company has settled with five of the eight filers, with three outstanding litigants remaining [39]

Financial Data and Key Metrics Changes - YUPELRI net sales increased by 6% to just over $58 million, driven by demand growth and favorable pricing [2][4] - Collaboration revenue reported at $15.4 million, up 6% year over year, with YUPELRI brand level cash profitability growing faster than collaboration revenue [16][18] - Operating expenses, excluding share-based compensation, increased to $25 million, primarily due to R&D and SG&A expenses [17][18] - The company ended the quarter with $131 million in cash and no debt, reflecting a strong financial position [18][22] Business Line Data and Key Metrics Changes - Hospital doses of YUPELRI increased by 48% year on year, achieving record high volume with approximately 316,000 units pulled through the hospital channel [2][6] - The performance of YUPELRI in the hospital setting is a key strategic differentiator, contributing significantly to overall brand growth [5][6] - TRELEGY reported global net sales of $854 million, up 14% year over year, positioning the company to achieve a $50 million milestone in 2025 [4][10] Market Data and Key Metrics Changes - Market research indicates significant future potential for YUPELRI, with additional demand growth expected [7] - The company is focused on transitioning hospital patients to community maintenance care, which is critical for long-term growth [6][8] Company Strategy and Development Direction - The company aims to deliver high-quality results in the Sypris trial, with a focus on enrolling the right patients and optimizing study factors [3][12] - YUPELRI is positioned as a foundational and highly profitable asset, with plans to achieve a $25 million near-term milestone and extended IP protection through 2039 [8][9] - The company is preparing for an expedited NDA submission for ampreloxetine, with ongoing engagement with the MSA community [12][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving higher-end milestones for TRELEGY, with consensus estimates for 2025 and 2026 increasing by approximately $100 million [10][11] - The company does not anticipate material impacts from potential tariff measures and remains focused on its value drivers [19][21] - Management highlighted the importance of the transition of care for hospital patients to ensure they receive ongoing treatment [28][30] Other Important Information - The company is actively engaging with payers regarding ampreloxetine and its potential role in treating nOH [33][34] - Five out of eight Paragraph IV filers have been settled regarding YUPELRI, with three litigants remaining [38] Q&A Session Summary Question: Status update on ampreloxetine manufacturing and IP - The IP for ampreloxetine is currently in Ireland, with API manufacturing outside the U.S. in Taiwan, allowing flexibility for future adjustments [26] Question: Efforts to increase hospital prescriptions to filled chronic prescriptions - The company is focused on ensuring patients receive support through fulfillment programs and follow-up care after leaving the hospital [27][30] Question: Feedback from payers on ampreloxetine - The company has started engaging with payers to educate them on the disease burden and the potential role of ampreloxetine [33][34] Question: Update on Paragraph IV filers for YUPELRI - Settlements have been reached with five of the eight filers, with three outstanding litigants [38]

Financial Data and Key Metrics Changes - In Q4 2024, YUPELRI net sales increased by 10% year-over-year, reaching $66.7 million, marking an all-time high [4] - Full year YUPELRI sales totaled $239 million, with an 8% increase in net sales for 2024 and an 11% growth in demand [11][14] - Collaboration revenue grew by 8% to approximately $19 million in Q4 [32] - Operating expenses, excluding share-based compensation, increased to $22 million due to higher commercial and medical affairs spending [32] Business Line Data and Key Metrics Changes - YUPELRI's hospital performance saw doses increase by 49% year-over-year, with 285,000 redoses pulled through to hospital customers [4][13] - The hospital business accounts for roughly 10% of total YUPELRI volume, with 90% coming from community settings [77] - Ample enrollment in the CYPRESS study for ampreloxetine is on track, with expectations for expedited NDA filing [5][20] Market Data and Key Metrics Changes - TRELEGY reported full year sales of $3.5 billion, up 26% year-over-year, triggering a $50 million milestone payment [15] - The company anticipates achieving an additional $150 million in milestones from TRELEGY in 2025 and 2026 [16] Company Strategy and Development Direction - The company aims to grow YUPELRI revenue while increasing brand profitability, with potential near-term sales milestones in the U.S. and royalties from China [7] - For ampreloxetine, the focus is on completing enrollment in the CYPRESS study and preparing for an expedited NDA filing [8] - The company is committed to maximizing the value of TRELEGY and returning excess capital to shareholders [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the financial position entering 2025, with $88 million in cash and no debt [39] - The company is focused on driving YUPELRI growth through strong demand generation and a patient-centered strategy [40] - Management highlighted the potential impact of ampreloxetine on patients with MSA suffering from nOH symptoms [41] Other Important Information - The company completed market research indicating a significant unmet need for better nOH therapies, with over 70% of surveyed neurologists agreeing [25] - The target product profile for ampreloxetine aligns with physician preferences, suggesting a favorable outlook if approved [28] Q&A Session Summary Question: What drove the success in the hospital channel this quarter? - The success was attributed to effective execution of strategy and wins in larger systems, with therapeutic interchange contributing to increased volume [45][46] Question: What is the trend for the hospital performance into 2025? - Q1 is typically softer, but there is a demonstrated need for YUPELRI, which may provide a tailwind [60] Question: What are the next steps for YUPELRI in China? - The company is waiting for regulatory feedback from Viatris, with a typical two-year window expected from submission to approval [62] Question: What was the nature of the recent FDA feedback on ampreloxetine? - The feedback was from a Type C meeting to clarify filing content and ensure alignment on key requirements for full approval [67] Question: What percentage of YUPELRI sales are non-hospital sales? - The hospital business accounts for roughly 10% of total YUPELRI volume, with the community setting making up the majority [77] Question: What is the bar for success for the CYPRESS readout? - A one-point change in the OHSA composite score is considered clinically meaningful for success [88]