Theravance Biopharma, Inc. Q4 FY2023 earnings call

• Began 2023 by focusing on driving YUPELRI growth, maximizing ampreloxetine value, and increasing capital return program.
• Achieved non-GAAP profitability in the fourth quarter. Completed $325 million capital return program in early January 2024.
• For 2024: Expect YUPELRI net sales growth and profit margin improvements. Viatris plans to submit YUPELRI regulatory application in China by mid-year. Focused on completing CYPRESS study and early commercialization preparations for ampreloxetine. To host a virtual investor event in the second quarter on ampreloxetine.

YUPELRI: Fourth quarter net sales were $61 million, full year net sales were $221 million, both up 9% from prior periods. Hospital volumes for YUPELRI grew 46% for the year. Revenue contribution: YUPELRI was the key segment with significant sales growth. Ampreloxetine: In development phase, with CYPRESS study initiated and orphan drug status granted in May 2023, focusing on completing the study and early commercialization preparations.

• Expect YUPELRI net sales to grow in 2024 and build on profit margin improvements.
• Anticipate approaching non-GAAP break-even in the second half of 2024.
• Potential to achieve $25 million TRELEGY sales milestone in 2024, possibly the higher $50 million milestone.
• Viatris plans to file YUPELRI in China by mid-year, eligible for $7.5 million milestone upon approval in China, with additional sales milestones and royalties of 14-20%.

• Risks related to forward-looking statements involving development pipeline, clinical trial timing, regulatory filings, and financial results.
• Uncertainties in CYPRESS study enrollment and regulatory approvals for ampreloxetine.
• Seasonality and market competition impacts on YUPELRI sales.

Q: About YUPELRI share gains from new accounts vs existing base.

A: Rhonda Farnum stated that the share gain in the hospital segment was drawn both from new accounts and existing accounts converting to therapeutic interchange, with roughly 35% of COPD focus accounts having a therapeutic interchange.

Q: About strategic opportunities to bring in another product.

A: Rick Winningham mentioned that the focus is on ampreloxetine and the CYPRESS study execution, with significant opportunity in YUPELRI hospital sales, and shifting focus to other products could be net harmful.

Q: About Q2 investor event for ampreloxetine and market opportunity vs NORTHERA.

A: Rick Winningham said the investor event will consolidate medical need info, and ampreloxetine has an opportunity in 40,000 MSA patients with nOH, optimistic about its potential.

Q: About China market opportunity for YUPELRI and CYPRESS enrollment split.

A: Rhonda Farnum mentioned Viatris plans to file YUPELRI in China by mid-year, and Aine Miller stated CYPRESS enrollment is expected to have a majority from Europe as prior studies, with efforts to expand in the U.S.