Core Insights - Theravance Biopharma (TBPH) reported a narrower adjusted net loss of 8 cents per share for Q2 2025, compared to the expected loss of 14 cents and a loss of 13 cents in the same quarter last year [1][7] - Total revenues for Q2 reached $26.2 million, exceeding the Zacks Consensus Estimate of $17 million, and reflecting an 83.2% year-over-year increase driven by collaboration and licensing revenues [2][7] - Year-to-date, Theravance's shares have increased by 26.6%, outperforming the industry average rise of 5.3% [2] Financial Performance - Revenues from the collaboration with Viatris related to Yupelri sales amounted to $18.7 million, marking a 31% increase year-over-year [8] - Viatris reported U.S. net sales of Yupelri at $66.3 million for Q2, a 22% increase year-over-year, indicating strong demand growth [5][7] - The company received a milestone payment of $7.5 million from Viatris following Yupelri's approval in China [8] Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) totaled $9.5 million, an increase of nearly 8% from the previous year [9] - Selling, general, and administrative expenses (excluding share-based compensation) rose approximately 16.4% year-over-year to $12.8 million [9] - Theravance reaffirmed its financial guidance for 2025, expecting adjusted R&D expenses between $32 million and $38 million, and SG&A expenses between $50 million and $60 million [10] Pipeline and Strategic Updates - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy [11] - The phase III CYPRESS study for ampreloxetine is expected to complete patient enrollment by late summer, with top-line data anticipated six months post-enrollment [12] - Theravance sold its remaining royalty interest in Trelegy Ellipta to GSK for $225 million, marking a strategic move to maximize shareholder value [13]

Core Insights - Theravance Biopharma (TBPH) has entered into an agreement to sell its remaining royalty interest in Trelegy Ellipta to GSK plc for $225 million in cash [1][2] - The transaction is part of Theravance's strategic review efforts to maximize shareholder value, with potential additional milestone payments of up to $150 million from Royalty Pharma based on Trelegy Ellipta's net sales in 2025 and 2026 [2][7] - Following the announcement, Theravance's shares increased by 22% [2] Financial Performance - Theravance's stock has increased by 18.5% year-to-date, contrasting with a 1.9% decline in the industry [3] - In February 2025, Theravance received a $50 million milestone payment based on Trelegy Ellipta's net sales of $3.46 billion in 2024, with a similar milestone payment of $150 million contingent on projected sales of approximately $3.41 billion in 2025 and $3.51 billion in 2026 [4][8] Revenue Generation - Theravance generates revenue from its collaboration with Viatris (VTRS) related to the sales of Yupelri, a nebulized therapy for COPD, sharing profits at a ratio of 35% for Theravance and 65% for Viatris [9][10] - In Q1 2025, Theravance reported $15.4 million in collaboration revenues from Yupelri sales, reflecting a year-over-year increase of 6.2% [11] Pipeline Development - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [11] - The phase III CYPRESS study for ampreloxetine is expected to complete patient enrollment by late summer, with top-line data anticipated six months post-enrollment [12]

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]

Core Viewpoint - Theravance Biopharma reported a wider-than-expected adjusted net loss for Q1 2025, indicating ongoing financial challenges despite a year-over-year revenue increase driven by collaboration revenues from Viatris [1][2]. Financial Performance - The adjusted net loss for Q1 2025 was 17 cents per share, compared to a loss of 11 cents estimated by Zacks Consensus, and a loss of 9 cents in the same quarter last year [1]. - Total revenues for the first quarter were $15.4 million, missing the Zacks Consensus Estimate of $16 million, but representing a 6.2% increase year-over-year due to higher collaboration revenues from Viatris [2]. - The reported loss, including share-based compensation and other expenses, was 27 cents per share, compared to a loss of 24 cents in the prior year [2]. Collaboration and Revenue Sources - Revenues were entirely derived from Viatris' collaboration related to Yupelri (revefenacin) sales, which is used for chronic obstructive pulmonary disease treatment [4]. - Viatris recorded $58.3 million in U.S. net sales of Yupelri for Q1 2025, reflecting a 6% year-over-year increase [6]. - Theravance receives 35% of the profits from Yupelri sales, while Viatris retains 65% [5]. Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) were $10.4 million, up 40.5% from the previous year, while selling, general, and administrative expenses increased by 13.2% to $14.6 million [10]. - Theravance reaffirmed its financial guidance for 2025, expecting adjusted R&D expenses between $32 million and $38 million, and SG&A expenses between $50 million and $60 million [11]. Pipeline Developments - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy [12]. - The phase III CYPRESS study for ampreloxetine is expected to complete patient enrollment by late summer, with top-line data anticipated six months post-enrollment [13].

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]

Core Viewpoint - Theravance Biopharma reported its financial and operational results for Q1 2025, highlighting growth in YUPELRI sales and advancements in clinical trials for ampreloxetine, while also addressing ongoing strategic reviews to enhance shareholder value [1][2][8]. Financial Performance - Total revenue for Q1 2025 was $15.4 million, entirely from Viatris collaboration revenue, which increased by $0.9 million, or 6%, compared to Q1 2024 [4][29]. - YUPELRI net sales reached $58.3 million, reflecting a 6% increase year-over-year [5][6]. - The company reported a net loss of $13.6 million for Q1 2025, compared to a net loss of $11.7 million in Q1 2024 [13][29]. Operational Highlights - The CYPRESS study for ampreloxetine is nearing completion, with final patient enrollment expected by late summer 2025 [5][6]. - Customer demand for YUPELRI grew by 5% in Q1 2025, with doses pulled through the hospital channel increasing by 48% year-over-year [6][5]. - The company presented data at the American Academy of Neurology 2025 Annual Meeting, showcasing the pharmacodynamic effects of ampreloxetine [6]. Strategic Initiatives - A Strategic Review Committee has been formed to evaluate alternatives aimed at unlocking shareholder value [8]. - The company continues to expect full-year 2025 R&D expenses between $32 million and $38 million, and SG&A expenses between $50 million and $60 million [14]. Market Context - Ampreloxetine is being developed for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), with potential for significant clinical benefits [15][19]. - There are approximately 50,000 MSA patients in the US, with 70-90% experiencing nOH symptoms, indicating a substantial unmet medical need [17][18].

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]