Accessibility StatementSkip Navigation DUBLIN, Nov. 20, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced that it will host a virtual key opinion leader (KOL) investor event on Monday, December 8, 2025 at 10:30 AM ET. To register, click here. The event will feature Horacio Kaufmann, MD (Dysautonomia Center, NYU Langone Health), who will join company management to discuss the unmet medical need for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple sys ...

Accessibility StatementSkip Navigation SOURCE Theravance Biopharma, Inc. 21% DUBLIN, Nov. 19, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced that management will participate in the following investor conferences in December 2025: 8 Annual Evercore Healthcare ConferenceLocation: Coral Gables, FLFormat: Fireside ChatDate: Thursday, December 4, 2025Time: 8:20-8:40 AM ETWebcast Oppenheimer Movers in Rare Disease SummitLocation: New York, NYFormat: Panel Discussion - Elevator Pitc ...

Sales Performance - YUPELRI (revefenacin) inhalation solution generated US net sales of $71.4 million in Q3 2025, a 15% increase from $62.2 million in Q3 2024[100]. - YUPELRI net sales for the three months ended September 30, 2025, were $71.4 million, a 15% increase year-over-year, and for the nine months, net sales were $196.0 million, also a 14% increase[122]. - Total revenues for the nine months ended September 30, 2025, were $61.6 million, a 35% increase compared to the prior year, driven by higher net sales of YUPELRI[125]. - TRELEGY global net sales for 2024 reached $3.46 billion, representing a 26% increase compared to 2023, and are expected to peak at approximately $4.0 billion in 2026[113]. - For the three months ended September 30, 2025, TRELEGY global net sales were $979 million, reflecting a 24% year-over-year growth, while for the nine months, sales were $2.92 billion, showing a 13% increase[113]. Milestone Payments and Royalties - The company is eligible to receive up to $205 million in potential global sales and regulatory milestone payments from Viatris, with $160 million associated with YUPELRI monotherapy[96]. - To achieve a $25 million sales milestone for YUPELRI in 2025, approximately $54 million in US net sales is required in Q4 2025[97]. - Viatris' Phase 3 study of YUPELRI in China yielded positive results, leading to regulatory approval and a $7.5 million milestone payment to the company[98]. - As of September 30, 2025, YUPELRI's cumulative net sales in the China Region could trigger additional sales milestones of up to $37.5 million[99]. - As of September 30, 2025, a total of $150.0 million in potential Milestone Payments remain available, with eligibility for $25.0 million or $50.0 million based on TRELEGY global net sales thresholds of approximately $3.06 billion and $3.41 billion, respectively[111]. - The company received a maximum $50 million milestone payment from Royalty Pharma in February 2025, based on achieving a minimum royalty amount from TRELEGY's global net sales of $3.46 billion in 2024[110]. - The company is eligible for tiered royalties on net sales of nebulized revefenacin in the China Region, with rates ranging from 14% to 20% based on sales thresholds[100]. Research and Development - Ampreloxetine is in a Phase 3 clinical study, with top-line data expected in Q1 2026, following positive results from earlier studies[106]. - Royalty Pharma invested $40 million in ampreloxetine, including a $25 million upfront payment and a $15 million payment upon the first regulatory approval[107]. Expenses and Financial Management - R&D expenses for the three months ended September 30, 2025, decreased by 12% to $8.1 million, primarily due to a reduction in external-related expenses[127]. - SG&A expenses for the three months ended September 30, 2025, were $18.3 million, a 9% increase compared to the prior year, with total SG&A expenses for the nine months at $55.1 million[131]. - Year-to-date G&A expenses (excluding SBC) increased by $2.7 million, primarily due to one-time legal costs; excluding these costs, G&A expenses were 3% lower compared to the prior year[134]. - Total SBC related to SG&A expenses was $3.5 million and $10.9 million for the three and nine months ended September 30, 2025, respectively, compared to $3.9 million and $11.8 million for the same periods in 2024[135]. - No impairment charges for long-lived assets were recognized for the three and nine months ended September 30, 2025, compared to non-cash impairment charges of $1.6 million and $4.5 million in the prior year[137]. Income and Cash Flow - A net gain of $75.1 million on realized contingent milestone and royalty assets was recognized for the nine months ended September 30, 2025, resulting from the sale of TRELEGY royalties to GSK[138]. - Interest expense for the three and nine months ended September 30, 2025, was $0.6 million and $1.9 million, respectively, representing non-cash interest expense associated with a $25.0 million funding received in July 2022[140]. - Interest and other income, net, increased by $2.7 million and $2.6 million for the three and nine months ended September 30, 2025, respectively, primarily due to increased interest income from cash and marketable securities[141]. - The provision for income tax expense for the nine months ended September 30, 2025, was $11.3 million, primarily due to the net gain on realized contingent milestone and royalty assets[144]. - As of September 30, 2025, the company had approximately $332.7 million in cash, cash equivalents, and investments in marketable securities, with no long-term debt[145]. - Net cash provided by operating activities was $244.6 million for the nine months ended September 30, 2025, driven by a net income of $44.9 million and significant cash inflows from milestone payments[149]. - Net cash used in investing activities was $105.9 million for the nine months ended September 30, 2025, primarily from the purchase and maturities of marketable securities[151]. Strategic Focus - The company remains focused on disciplined capital allocation and evaluating strategic alternatives to enhance shareholder value, as initiated by the Strategic Review Committee[115].

Core Insights - Theravance Biopharma (TBPH) reported third-quarter 2025 adjusted earnings of 4 cents per share, exceeding the Zacks Consensus Estimate of a loss of 3 cents, and improved from an adjusted loss of 6 cents per share in the same quarter last year [1][6] - Total revenues for the third quarter reached $20 million, aligning with the Zacks Consensus Estimate, and reflecting a 19% year-over-year increase driven by collaboration revenues from partner Viatris (VTRS) [1][6] Financial Performance - The revenue for the quarter was solely derived from Viatris' collaboration revenues related to Yupelri (revefenacin) sales [3] - U.S. sales of Yupelri increased by 15% year over year, contributing to the positive financial results [6] - Viatris recorded $71.4 million in U.S. net sales of Yupelri for the third quarter, marking a 15% increase from the previous year [7] Expense Management - Research and development expenses (excluding share-based compensation) totaled $7 million, a decrease of approximately 14.6% from the year-ago quarter [7] - Selling, general and administrative expenses (excluding share-based compensation) rose around 13.8% year over year to $14.8 million [7] Cash Position - As of September 30, 2025, Theravance had cash, cash equivalents, and marketable securities amounting to $332.7 million, down from $338.8 million as of June 30, 2025 [8] Financial Guidance - Theravance reaffirmed its financial guidance for 2025, expecting adjusted R&D expenses (excluding share-based compensation) in the range of $32-$38 million and adjusted SG&A expenses between $50 million and $60 million [9] - The company anticipates share-based compensation expenses of $18-$20 million in 2025 [9] Pipeline Developments - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [11] - The pivotal phase III CYPRESS study for ampreloxetine has completed enrollment, with top-line data expected in the first quarter of 2026 [11] - An expedited new drug application (NDA) filing for ampreloxetine is planned if the study data are positive, with a request for priority review from the FDA [12]

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].