Anticipated Milestones of $150 Million for Theravance as CYPRESS trial approaches critical data unveiling
Theravance Biopharma, Inc. (TBPH) held a Q2 2025 earnings call to discuss the company's financial performance during the quarter. CEO Rick E. Winningham highlighted the excellent performance of two key products, YUPELRI and ampreloxetine, as well as a significant investment.
YUPELRI Sales Growth
The call saw Winningham announcing that YUPELRI (revefenacin), a long-acting muscarinic antagonist used for the maintenance treatment of chronic obstructive pulmonary disease (COPD), had net sales of $66.3 million in the U.S., marking a 22% year-over-year increase. This growth was primarily driven by strong demand in the hospital channel and specialty pharmacy, as well as the recent approval of YUPELRI in China triggering a $7.5 million milestone payment from Viatris.
Advancing Ampreloxetine Development
Regarding ampreloxetine, a once-daily, selective norepinephrine reuptake inhibitor targeting symptom relief in Multiple System Atrophy (MSA), Winningham reported that the pivotal Phase 3 CYPRESS study is progressing well, with enrollment on track to complete by late summer 2025. The company plans to report top-line data approximately six months after enrollment completion. Winningham also emphasised the significant unmet need for ampreloxetine, which supports its commercial potential.
Transformative $225 Million Investment
Winningham also announced the completion of a $225 million strategic sale of TBPH's remaining TRELEGY ELLIPTA royalty interest to GSK. This investment significantly strengthens TBPH's financial position, providing strong cash flow and enhancing balance sheet flexibility. TRELEGY year-to-date sales in 2025 are on track to trigger a $50 million milestone payment, with a further $100 million milestone expected in 2026.
TBPH reported strong Q2 2025 financial performance, with an 83.7% revenue increase to $26.2 million and net income surging 431.8% to $54.84 million. The Viatris collaboration (which includes YUPELRI royalties) contributed $18.7 million in revenue, plus $7.5 million from licensing and milestone payments overall. Winningham emphasised "strong execution...driven by commercial growth, disciplined operations, and continued progress on ampreloxetine" as well as momentum entering the second half of 2025 focused on ampreloxetine and key data readouts.
In summary, the CEO highlighted robust YUPELRI sales growth including China milestone, advancing pivotal trial progress for ampreloxetine, and a transformative $225 million royalty interest sale that together underpin TBPH’s strong Q2 financial and operational results.
In light of Theravance Biopharma's (TBPH) robust Q2 2025 financial results, a substantial investment of $225 million in the form of a strategic sale of TBPH's remaining TRELEGY ELLIPTA royalty interest to GSK was announced, which will potentially boost health-and-wellness by providing significant resources for future research and development, particularly in medical-conditions such as Multiple System Atrophy (MSA), where ampreloxetine may offer relief. The pivotal Phase 3 CYPRESS study for ampreloxetine is progressing well, and it is expected to deliver top-line data once enrollment is complete. Meanwhile, YUPELRI, a COPD treatment, recorded a 22% year-over-year increase in net sales due to strong demand in the hospital channel and specialty pharmacy, as well as its recent approval in China.
