Theravance Biopharma Announces Approval of YUPELRI® (revefenacin) by China's NMPA

• YUPELRI approved by China's NMPA as the first once-daily nebulized LAMA for maintenance treatment of COPD
• Approval triggers $7.5 million milestone payment from Viatris, with eligibility to receive further sales milestones and tiered royalties on net sales in China
• Theravance Biopharma incurs no commercial costs in China; Viatris is responsible for the launch and commercialization

DUBLIN, June 26, 2025 — Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that Viatris Inc. ("Viatris"), has secured regulatory approval from China's National Medical Products Administration (NMPA) for YUPELRI® (revefenacin) inhalation solution, the first once–daily nebulized long–acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) in China.

This approval triggers a one-time $7.5 million milestone from Viatris to Theravance Biopharma, which is expected to be received in Q3 2025. Theravance Biopharma is also eligible for further sales-based milestones of up to $37.5 million and tiered royalties of 14% to 20% on net sales in China. Viatris is responsible for all aspects of development and commercialization of YUPELRI in China.

Today's announcement offers further support for Theravance Biopharma's diversified and improving financial position, which includes $131 million in cash as of March 31, 2025, an additional $225 million from the recent sale of TRELEGY royalties to GSK, 35% of U.S. YUPELRI profits, and up to $150 million in near-term potential TRELEGY milestone payments from Royalty Pharma. It also comes as the Company nears completion of enrollment in the open label portion of CYPRESS, its registrational study of ampreloxetine in symptomatic neurogenic orthostatic hypotension associated with multiple system atrophy. Ampreloxetine is a wholly-owned asset with the potential to address a significant unmet need in this rare neurological disorder.

About Ampreloxetine

Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the US, the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.

About CYPRESS (Study 0197), a Phase 3 Study

Study 0197 (NCT05696717) is currently enrolling. This is a registrational Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. The Study includes four periods: screening, open label (12-week period, participants will receive a single daily 10 mg dose of ampreloxetine), randomized withdrawal (eight-week period, double-blind, placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine), and a long-term treatment extension. Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that require standing for a short time) and item 3 (activities that require walking for a short time).

About Theravance Biopharma

Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value.

For more information, please visit www.theravance.com.

THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries).

YUPELRI® is a registered trademark of Viatris Specialty LLC. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.