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]

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]

Core Insights - Theravance Biopharma is presenting new analyses of the Phase 3 program for ampreloxetine at the upcoming AAN Meeting, highlighting its selective pharmacodynamic profile [1][2] - The ongoing CYPRESS Study 197 aims to confirm the efficacy of ampreloxetine in treating neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][4] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a once-daily norepinephrine reuptake inhibitor for symptomatic nOH in MSA patients [3][9] - 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 [3] Clinical Study Details - The CYPRESS Study 197 is a multi-center, randomized withdrawal study evaluating the efficacy of ampreloxetine after 20 weeks of treatment, with a primary endpoint of change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [4] - Previous studies (Study 169 and Study 170) indicated that while Study 169 did not meet its primary endpoint, a subgroup analysis suggested significant benefits for MSA patients, showing a 72% reduction in treatment failure odds with ampreloxetine [5][6] Disease Context - Multiple system atrophy (MSA) is a progressive disorder affecting movement and autonomic functions, with approximately 50,000 patients in the U.S., and 70-90% experiencing nOH symptoms [7][8] - Neurogenic orthostatic hypotension (nOH) is characterized by significant drops in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [8]