Theravance Biopharma's YUPELRI approved in China, triggers $7.5mln milestone payment from Viatris.

• Theravance Biopharma's YUPELRI approved in China for COPD treatment • First once-daily nebulized LAMA for maintenance treatment • Approval triggers $7.5mln milestone payment from Viatris • Viatris responsible for commercialization in China • Theravance incurs no commercial costs in China • Eligible for further sales milestones and royalties on net sales in China

DUBLIN, June 19, 2025 — Theravance Biopharma, Inc. (NASDAQ: TBPH) has announced that its partner, Viatris Inc., has received regulatory approval from China's National Medical Products Administration (NMPA) for YUPELRI® (revefenacin) inhalation solution. This approval marks a significant milestone for Theravance Biopharma, as it is the first once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) in China.

The approval triggers a one-time milestone payment of $7.5 million from Viatris to Theravance Biopharma, which is expected to be received in the third quarter of 2025. Additionally, Theravance Biopharma is eligible for further sales-based milestones of up to $37.5 million and tiered royalties of 14% to 20% on net sales in China. Notably, Theravance Biopharma incurs no commercial costs in China, with Viatris responsible for all aspects of development and commercialization of YUPELRI.

This approval comes at a critical time for Theravance Biopharma, which has been focusing on strengthening its financial position. The company currently holds $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. Furthermore, the company is nearing 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.

The approval of YUPELRI in China represents a significant regulatory achievement for Theravance Biopharma, establishing the drug as the first once-daily nebulized LAMA treatment for COPD in the world's largest potential COPD market. China has over 100 million COPD patients, creating substantial commercial opportunity. The financial structure of this deal is particularly advantageous for Theravance Biopharma, as it receives an immediate $7.5 million milestone payment expected in Q3 2025, with potential for additional sales milestones up to $37.5 million and tiered royalties on net sales in China.

References:
[1] https://finance.yahoo.com/news/theravance-biopharma-announces-approval-yupelri-100000193.html
[2] https://www.stocktitan.net/news/TBPH/theravance-biopharma-announces-approval-of-yupelri-revefenacin-by-93dupui8ifq3.html