Theravance Biopharma, Inc. Q2 FY2024 earnings call

Management Statement and Operational Highlights

• YUPELRI: Strong volume growth in hospital doses, customer demand up, but net price reduction. Viatris filed NDA in China and secured a new patent for YUPELRI.
• Ampreloxetine: CYPRESS study enrollment timeline revised; focus on academic institutions and MSA centers for high-quality study. Need to ensure sufficient patients for randomized withdrawal portion of the study.
• Financials: Ended the quarter with $96 million in cash, no debt. Expect losses in second half of 2024, with cash utilization similar to or above first half.
• Trilogy Collaboration: Trelegy sales strong, Q2 net sales up 40% YOY, year-to-date $1.8 billion. Increasing optimism to achieve milestones for Trelegy in 2024 and beyond.

Segment Performance

• YUPELRI: Reported $54.5 million in net sales. Hospital doses up 43% year-over-year, overall customer demand up 13%, but net realized price reduction led to 1% year-over-year decrease in net sales. Viatris filed NDA for YUPELRI in China in June, and a new YUPELRI method of use patent was granted in July.
• Ampreloxetine: Updated timeline for CYPRESS study; now expect to enroll the last patient in the open-label portion mid-2025 (previously guided second half 2024) due to longer site activation lead times. Focus on working with academic institutions and MSA centers of excellence for high-quality study.
• Trilogy (GSK collaboration): GSK reported sales up 40% year-to-date, bringing year-to-date sales to $1.8 billion, up 37%. Increased confidence in achieving the $50 million sales milestone for 2024 and potential milestones in 2025-2026.

Guidance

• YUPELRI: Slight price improvement expected in second half, net sales to increase relative to Q2. 2025 and beyond expected stable pricing with continued demand growth.
• Ampreloxetine: CYPRESS study top line results expected ~6 months after final open-label enrollment (mid-2025).
• Trilogy: Increasing optimism to achieve at least the lower $25 million milestone for Trelegy in 2024, potentially higher, with potential $150 million in 2025-2026.

Risks

• YUPELRI: Channel mix variability affecting net realized price; ongoing Paragraph IV litigations.
• Ampreloxetine: Longer than expected enrollment timeline for CYPRESS study due to site activation challenges.

Question and Answer

Q: Details on YUPELRI channel mix affecting net price A: Channel mix has varied discounting ranges across channels. Viatris taking corrective measures, expecting pricing improvement in 2025 and beyond; second half net sales expected to increase relative to Q2 Q: Update on Paragraph IV litigations for YUPELRI A: Settled with four litigants, in ongoing litigation with seven in New Jersey and one in Pennsylvania; new patent added to orange book Q: CYPRESS study enrollment and data timeline A: Now expect to enroll last patient in open-label mid-2025, top line data ~6 months after; need sufficient patients for randomized withdrawal portion to end up with 60 evaluable patients Q: YUPELRI revenue growth confidence A: Continued demand growth and slight pricing improvement in second half expected to drive net sales growth