Topline results anticipated in Q1 2026 and, if successful, planning for expedited NDA submission  If approved, ampreloxetine could address a critical unmet need as the first therapy with the potential to provide durable benefit for the 40,000 patients in the U.S. with symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) Ampreloxetine has Orphan Drug Designation in the U.S., underscoring the unmet need in symptomatic nOH due to MSADUBLIN, Aug. 25, 2025 /PRNewsw ...

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 Insights - Theravance Biopharma reported strong execution in Q2 2025, driven by commercial growth and operational discipline, with significant progress on ampreloxetine and a milestone payment from YUPELRI's approval in China [2][5][10] Financial Performance - Total revenue for Q2 2025 was $26.2 million, comprising $18.7 million from Viatris collaboration and $7.5 million from licensing revenue [10] - Viatris collaboration revenue increased by 31% year-over-year, amounting to $18.7 million in Q2 2025 [10] - Net income for Q2 2025 was $54.8 million, a significant improvement from a net loss of $16.5 million in Q2 2024 [10][30] - Non-GAAP net loss from operations was $4.2 million in Q2 2025, compared to a loss of $6.3 million in the same period in 2024 [10][30] Operational Highlights - YUPELRI net sales reached $66.3 million in Q2 2025, reflecting a 22% increase year-over-year [5][6] - The pivotal Phase 3 CYPRESS study for ampreloxetine is on track for enrollment completion by late summer 2025, with top-line data expected approximately six months later [5][10] - The company completed the sale of its TRELEGY royalty interest to GSK for $225 million, enhancing its financial position [5][10] Cash Position and Guidance - As of June 30, 2025, the company had $339 million in cash and no debt, indicating a strong balance sheet [5][10] - The company anticipates full-year 2025 global net sales to exceed $3.4 billion, with a milestone of $50 million from Royalty Pharma expected to be triggered [5][10] Strategic Focus - The company is focused on disciplined capital allocation and returning excess cash to shareholders, with ongoing evaluations of strategic alternatives to enhance shareholder value [7][10]

Core Viewpoint - Theravance Biopharma, Inc. is set to report its second quarter 2025 financial results and provide a business update on August 12, 2025, after market close [1] Company Overview - Theravance Biopharma focuses on delivering innovative medicines, including the FDA-approved YUPELRI® for chronic obstructive pulmonary disease (COPD) [3] - The company is developing Ampreloxetine, a late-stage investigational drug for neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), which has the potential to be a first-in-class therapy [3] - Theravance Biopharma is committed to creating and driving shareholder value [3]

Core Viewpoint - Theravance Biopharma announces that Viatris has received regulatory approval in China for YUPELRI® (revefenacin), marking it as the first once-daily nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in the country [1][7] Financial Impact - The approval triggers a one-time milestone payment of $7.5 million from Viatris to Theravance Biopharma, expected in Q3 2025 [2] - Theravance Biopharma is also eligible for additional sales-based milestones of up to $37.5 million and tiered royalties ranging from 14% to 20% on net sales in China [2] - The company reported a financial position that includes $131 million in cash as of March 31, 2025, and an additional $225 million from the recent sale of TRELEGY royalties to GSK [3] Product Development - Theravance Biopharma is nearing completion of enrollment in the open label portion of CYPRESS, a registrational study for ampreloxetine, which targets symptomatic neurogenic orthostatic hypotension associated with multiple system atrophy [3] - Ampreloxetine has shown potential benefits in increasing norepinephrine levels and improving blood pressure without worsening supine hypertension in MSA patients [4] Study Details - The CYPRESS study (Study 0197) is a Phase 3, multi-center, randomized withdrawal study evaluating the efficacy and durability of ampreloxetine after 20 weeks of treatment [5] - The primary endpoint of the study is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [5] Company Overview - Theravance Biopharma focuses on delivering innovative medicines, with YUPELRI® approved for COPD maintenance treatment and ampreloxetine in late-stage development for symptomatic neurogenic orthostatic hypotension [6][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]

Core Insights - Theravance Biopharma presented analyses of its Phase 3 program for ampreloxetine, targeting symptomatic neurogenic orthostatic hypotension (nOH) at the International MSA Congress in Boston [1][2] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a selective norepinephrine reuptake inhibitor for treating nOH in patients with multiple system atrophy (MSA) [6][13] - The company has received Orphan Drug Designation for ampreloxetine in the U.S. and plans to file a New Drug Application (NDA) if ongoing studies yield positive results [6] Clinical Study Findings - A subgroup analysis from the REDWOOD 0170 study indicated that MSA patients had the highest nOH symptom burden, emphasizing the need for improved therapies [2] - Results from the studies support the ongoing registrational study (CYPRESS) evaluating ampreloxetine's efficacy in MSA patients [3] - Patients with MSA showed clinically meaningful improvement in nOH symptoms after 16 weeks of treatment with ampreloxetine, with stable symptoms in the treatment group compared to worsening in the placebo group [7][10] Study Details - The CYPRESS study is a Phase 3, multi-center, randomized withdrawal trial assessing ampreloxetine's efficacy after 20 weeks of treatment, with primary endpoints focused on changes in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [9] - The REDWOOD 0170 study included a 16-week open-label period followed by a 6-week double-blind, placebo-controlled withdrawal period, with a primary endpoint of treatment failure defined by specific worsening scores [10] Patient Impact - MSA patients experience severe symptoms affecting their quality of life due to nOH, with 70-90% of MSA patients experiencing these symptoms [11] - The clinical profile of ampreloxetine demonstrated target engagement and sustained blood pressure effects, indicating its potential as a first-in-class therapy for MSA-related nOH [6][7]

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]

Company Overview - Theravance Biopharma, Inc. focuses on delivering innovative medicines that improve patients' lives, leveraging decades of expertise in the biopharmaceutical industry [3] - The company has developed the FDA-approved YUPELRI® (revefenacin) inhalation solution for the maintenance treatment of chronic obstructive pulmonary disease (COPD) [3] - Ampreloxetine, a late-stage investigational drug, is being developed for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), with potential to be a first-in-class therapy [3] Upcoming Financial Results - Theravance Biopharma will report its first quarter 2025 financial results and provide a business update on May 8, 2025, after market close [1] - A conference call and webcast will be held on the same day at 5:00 pm EDT [1][2] Conference Call Participation - Participants can join the live call by dialing (800) 715-9871 from the US or (646) 307-1963 for international callers, using Conference ID 3369474 [2] - The conference call will also be available for live streaming on Theravance Biopharma's website [2] - A replay of the webcast will be accessible for 30 days until June 7, 2025 [2]