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 ...

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 will present new analyses on YUPELRI at the CHEST 2025 annual meeting, highlighting its effectiveness in reducing exacerbations in COPD patients [1][2] Company Overview - Theravance Biopharma focuses on delivering impactful medicines, with YUPELRI (revefenacin) approved for the maintenance treatment of COPD [3] - The company is also developing Ampreloxetine, a potential first-in-class therapy for neurogenic orthostatic hypotension in patients with Multiple System Atrophy [3] Research Findings - A retrospective analysis showed that patients adherent to YUPELRI had significantly fewer exacerbations and lower healthcare costs compared to non-adherent patients [2][6] - Post-hoc analyses from a Phase 3 safety study indicated that YUPELRI's exacerbation profile over one year is at least as effective as tiotropium [2][6] Presentation Details - The presentations at CHEST 2025 include: - "Exacerbation Rates in COPD Patients: A Retrospective Analysis of the Nebulized Once Daily Long-Acting Muscarinic Antagonist Revefenacin in a 52-Week Safety Study" by Edmund J Moran, Ph.D. on October 21, 2025 [2] - "Adherence to Revefenacin Associated with Reductions in Exacerbations and Healthcare Costs Following a COPD-Related Hospitalization" by Grace Leung, MPH on October 21, 2025 [2]

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].