Core Viewpoint - Theravance Biopharma reported quarterly earnings of $0.04 per share, exceeding the Zacks Consensus Estimate of a loss of $0.03 per share, marking a significant improvement from a loss of $0.06 per share a year ago, resulting in an earnings surprise of +233.33% [1] Financial Performance - The company achieved revenues of $19.99 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 2.08%, compared to revenues of $16.87 million in the same quarter last year [2] - Over the last four quarters, Theravance Biopharma has exceeded consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Performance - Theravance Biopharma shares have increased approximately 56.8% since the beginning of the year, significantly outperforming the S&P 500's gain of 14.4% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $0.21 on revenues of $59.99 million, while for the current fiscal year, the estimate is -$0.08 on revenues of $121.29 million [7] - The outlook for the Medical - Drugs industry, in which Theravance operates, is favorable, ranking in the top 37% of over 250 Zacks industries, suggesting potential for outperformance [8]

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 robust financial position [4][18] - Collaboration revenue increased to $20 million, up 19% year-over-year, driven by YUPELRI's strong operating leverage [18] Business Line Data and Key Metrics Changes - YUPELRI net sales increased 15% year-over-year to $71.4 million, supported by strong demand growth and favorable net pricing [6][7] - Profit margins for YUPELRI reached record levels, with hospital volume increasing 29% year-over-year [7][9] - The hospital channel's share in the long-acting nebulized market reached approximately 21%, a new high since launch [7] Market Data and Key Metrics Changes - The strong growth trends for Trelegy are expected to lead to a $100 million milestone in 2026, with current sales performance exceeding required thresholds [4][17] - The company is on track to achieve near-term milestones totaling $75 million in Q4 2025, including $50 million for Trelegy and $25 million for YUPELRI [4][19] Company Strategy and Development Direction - Theravance is focused on advancing the pivotal phase III CYPRESS trial of ampreloxetine, with data readout expected in early 2026 [3][15] - The company aims to position ampreloxetine 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's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of the CYPRESS study and the potential of ampreloxetine to be a significant value inflection point for the company [3][20] - The company is optimistic about the upcoming CYPRESS data readout, viewing it as a transformational catalyst with meaningful upside potential [20] - Management emphasized the importance of financial strength and operational efficiency in supporting future growth and capital returns to shareholders [22][23] Other Important Information - The company plans to host a KOL event for investors on December 8th to discuss the unmet medical needs of patients with MSA and the potential of ampreloxetine [4][16] - The operational execution of the CYPRESS study has been aligned with FDA guidelines, ensuring adequate powering for the trial [40] Q&A Session Summary Question: How is the company thinking about capital return to shareholders in light of Trelegy's performance? - Management highlighted 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 reiterated the focus on YUPELRI and ampreloxetine, stating that future options will be evaluated post-ampreloxetine success [25][26] Question: How does the recently published manuscript inform expectations for CYPRESS data? - Management noted that a one-point difference in the composite score is considered clinically meaningful and is crucial for the CYPRESS study [30][33] Question: Can the company share enrollment numbers for the CYPRESS study? - Management confirmed confidence in enrollment numbers and operational execution, stating that the study is adequately powered [40][41]

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]

Theravance Biopharma Third Quarter 2025 Financial Results and Business Update November 10, 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 Examples of such statements include statement ...

Financial Performance - YUPELRI achieved all-time high U.S. net sales of $71.4 million in Q3 2025, a 15% increase year-over-year driven by 6% customer demand growth [4]. - Total revenue for Q3 2025 was $20.0 million, with Viatris collaboration revenue increasing by 19% compared to Q3 2024 [13]. - Net income for Q3 2025 was $3.6 million, compared to a net loss of $12.7 million in Q3 2024, benefiting from a $6.5 million income tax benefit [17]. - Non-GAAP net income from operations was $2.3 million in Q3 2025, compared to a non-GAAP net loss of $2.9 million in Q3 2024 [17]. - Total revenue for Q3 2025 was $19,990,000, an increase of 18.5% compared to $16,868,000 in Q3 2024 [36]. - YUPELRI net sales recorded by Viatris for Q3 2025 were $71,363,000, up from $62,189,000 in Q3 2024, reflecting a growth of 17.5% [36]. - The company reported a net income of $3,615,000 for Q3 2025, compared to a net loss of $12,698,000 in Q3 2024, marking a significant turnaround [36]. - Non-GAAP net income for Q3 2025 was $2,260,000, compared to a loss of $2,897,000 in Q3 2024 [38]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $332.7 million as of September 30, 2025, with no debt [17]. - Cash and cash equivalents increased to $329,680,000 as of September 30, 2025, up from $88,350,000 at the end of 2024 [33]. - Total current assets rose to $354,697,000 as of September 30, 2025, compared to $161,067,000 at the end of 2024 [33]. - Shareholders' equity increased to $232,681,000 as of September 30, 2025, compared to $175,545,000 at the end of 2024 [33]. - The company has a future contingent milestone and royalty asset valued at $144,200,000 as of December 31, 2024 [33]. Research and Development - Research and Development expenses for Q3 2025 were $8.1 million, down from $9.3 million in Q3 2024 [13]. - Research and development expenses for Q3 2025 were $8,112,000, a decrease from $9,268,000 in Q3 2024 [36]. - The open-label portion of the pivotal Phase 3 CYPRESS study of ampreloxetine is complete, with topline results expected in Q1 2026 [6]. - The company plans to host a virtual Key Opinion Leader event on December 8, 2025, to discuss ampreloxetine's potential in treating neurogenic orthostatic hypotension [9]. Future Projections - The company is on track to exceed full year 2025 global net sales of approximately $3.4 billion, requiring $471 million in Q4 2025 to trigger a $50 million milestone from Royalty Pharma [12]. - Year-to-date sales of TRELEGY are on track to achieve a $50 million milestone in 2025, with global net sales of approximately $2.9 billion, up 13% year-over-year [7]. Expenses - Selling, general and administrative expenses increased to $18,333,000 in Q3 2025 from $16,875,000 in Q3 2024 [36].

Core Insights - Theravance Biopharma reported strong third-quarter results, achieving record net sales for YUPELRI and reaching non-GAAP breakeven, indicating financial and operational discipline [2][4][11] - The company is advancing ampreloxetine towards pivotal Phase 3 CYPRESS study topline results expected in Q1 2026, with a focus on addressing unmet needs in multiple system atrophy patients [2][3][15] Operational Highlights - YUPELRI net sales reached an all-time high of $71.4 million, a 15% increase year-over-year, driven by a 6% growth in customer demand and improved net pricing [4][5] - The open-label portion of the pivotal Phase 3 CYPRESS study for ampreloxetine is complete, with topline results anticipated in Q1 2026 [4][11] - The company plans to host a virtual Key Opinion Leader event on December 8, 2025, to discuss ampreloxetine's potential in treating neurogenic orthostatic hypotension [5][11] Financial Performance - Total revenue for Q3 2025 was $20.0 million, with Viatris collaboration revenue increasing by 19% compared to Q3 2024 [11][31] - R&D expenses for Q3 2025 were $8.1 million, down from $9.3 million in the same period in 2024, while SG&A expenses rose to $18.3 million from $16.9 million [11][31] - Net income for Q3 2025 was $3.6 million, a significant improvement from a net loss of $12.7 million in Q3 2024, aided by a $6.5 million income tax benefit [11][33] Strategic Initiatives - The company is preparing for an expedited NDA submission for ampreloxetine, contingent on supportive data from the ongoing study [5][15] - Theravance Biopharma continues to focus on disciplined capital allocation and returning excess cash to shareholders, with a Strategic Review Committee assessing strategic alternatives [18][20]

Core Insights - Theravance Biopharma Inc. has received an upgrade in its MSCI ESG rating from BBB to A as of October 30, 2025 [1] Company Summary - The upgrade reflects an improvement in Theravance Biopharma's environmental, social, and governance practices [1]

Core Insights - CorMedix (CRMD) and Theravance Biopharma (TBPH) are small-cap biotechnology companies with market caps under $1 billion, operating in niche therapeutic markets and characterized by limited product portfolios and high volatility potential for investors [1][5] CorMedix (CRMD) - CorMedix's lead product, DefenCath, received FDA approval in late 2023 as the first antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections in adult patients undergoing hemodialysis [2] - DefenCath generated $78.8 million in net revenues in the first half of 2025, with expectations for strong year-over-year growth in the third quarter [7] - The company plans to expand DefenCath's label into total parenteral nutrition, enhancing its customer base [8] - CorMedix acquired Melinta Therapeutics for $300 million, adding seven approved therapies to its portfolio and diversifying its revenue streams [9] - Preliminary third-quarter 2025 results showed net revenues exceeding $125 million, prompting an increase in full-year revenue guidance to at least $375 million [12] - The Zacks Consensus Estimate for CorMedix's 2025 sales and EPS indicates year-over-year increases of approximately 488% and 717%, respectively [19] Theravance Biopharma (TBPH) - Theravance collaborates with Viatris to commercialize Yupelri, a nebulized treatment for COPD, sharing profits with Viatris receiving 65% and Theravance 35% [13] - Revenues from the Viatris collaboration rose 19% year-over-year to $34.1 million in the first half of 2025 [15] - Theravance is developing ampreloxetine for neurogenic orthostatic hypotension, with top-line data expected in Q1 2026 [16] - The company sold its remaining royalty interest in Trelegy Ellipta to GSK for $225 million, strengthening its balance sheet [17] - The Zacks Consensus Estimate for Theravance's 2025 sales implies an 88% year-over-year increase, with a projected 75% narrowing of loss per share [19] Comparative Analysis - CorMedix's strategy focuses on immediate revenue generation through DefenCath, while Theravance relies on a partnership for revenue and is dependent on the success of its late-stage drug program [4][31] - CorMedix's diversified portfolio and strong commercial execution position it favorably compared to Theravance, which faces higher risks due to its limited pipeline and reliance on a single collaboration [31] - Year-to-date, CRMD shares have gained 39.6%, while TBPH shares have increased by 50.5%, outperforming the industry average of 10.7% [24]

Core Viewpoint - Theravance Biopharma is set to present its clinical development program for ampreloxetine, a potential treatment for neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), at the upcoming International Symposium on the Autonomic Nervous System [1][2]. Company Presentations - The company will have one platform presentation and three poster presentations at the symposium, focusing on the efficacy and methodologies related to ampreloxetine [1][2]. - The platform presentation will highlight results from the REDWOOD trial, showcasing durable symptomatic benefits of ampreloxetine in MSA patients [2]. - The three poster presentations will cover topics such as the impact of ampreloxetine on supine hypertension, retention strategies in rare disease clinical trials, and enrollment strategies in a Phase III trial for MSA-related nOH [2]. About Ampreloxetine - Ampreloxetine is an investigational, once-daily norepinephrine reuptake inhibitor aimed at treating symptomatic nOH in MSA patients [2][8]. - The treatment has shown an increase in norepinephrine levels and a favorable impact on blood pressure, with no worsening of supine hypertension reported [2]. - The company has received Orphan Drug Designation for ampreloxetine in the U.S. and plans to file a New Drug Application (NDA) if the ongoing Phase 3 CYPRESS study yields positive results [2]. Phase 3 Studies - The CYPRESS study is a registrational Phase 3 trial evaluating the efficacy and durability of ampreloxetine in MSA patients with symptomatic nOH after 20 weeks of treatment [3]. - The primary endpoint is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [3]. - The REDWOOD study previously indicated that the benefits of ampreloxetine were particularly significant in MSA patients, with a 72% reduction in the odds of treatment failure compared to placebo [5]. Disease Context - Multiple system atrophy (MSA) is a progressive brain disorder affecting movement and balance, with approximately 50,000 patients in the U.S. [6]. - 70-90% of MSA patients experience symptomatic nOH, which is characterized by a significant drop in blood pressure upon standing [6][7]. - Neurogenic orthostatic hypotension (nOH) can lead to debilitating symptoms, including dizziness and fainting, severely impacting patients' quality of life [7].