Release Date: August 05, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Theravance Biopharma Inc (TBPH, Financial) reported $54.5 million in net sales for YUPELRI, reflecting strong volume growth and demand generation.
- Hospital doses of YUPELRI increased by 43%, and overall customer demand rose by 13% year-over-year.
- Theravance Biopharma Inc (TBPH) was granted a new YUPELRI method of use patent with a 2039 expiration date, listed in the FDA Orange Book.
- GSK reported a 40% increase in Trelegy sales, bringing year-to-date sales to $1.8 billion, boosting confidence in achieving significant sales milestones.
- Theravance Biopharma Inc (TBPH) finished the quarter with $96 million in cash and no debt, indicating strong financial health.
Negative Points
- Net sales for YUPELRI decreased by 1% year-over-year due to a reduction in net realized price.
- Theravance Biopharma Inc (TBPH) no longer expects to approach non-GAAP breakeven and instead anticipates reporting losses in the second half of 2024.
- The CYPRESS study for Ampreloxetine has experienced delays, with the last patient enrollment now expected in mid-2025, pushing top-line results to approximately six months later.
- The company incurred a $3 million non-cash impairment charge due to the write-down in the value of its operating lease assets related to excess lab space.
- YUPELRI's net sales performance was disappointing due to lower-than-anticipated realized net price, reflecting the brand's evolved channel mix.
Q & A Highlights
Q: How did the unexpected pricing dynamics for YUPELRI arise, and what corrective actions are being taken?
A: Rhonda Farnum, Chief Business Officer: The channel mix for YUPELRI shifted, putting pressure on gross to net pricing. Viatris manages the pricing and contracting, and they have taken corrective measures to improve pricing, which we expect to see more significantly in 2025 and beyond. Despite the current challenges, we anticipate slight improvements in net price in the second half of the year.
Q: Can you provide an update on the Paragraph IV litigations for YUPELRI?
A: Rick Winningham, CEO: We have settled with four of the original litigants. Currently, there are eight litigants in total, seven in New Jersey and one in Pennsylvania. Additionally, we have added a new patent for YUPELRI in the FDA Orange Book.
Q: What are the pricing dynamics for YUPELRI in China compared to the US?
A: Rick Winningham, CEO: We do not have specific comments on pricing in China at this time. Viatris will likely provide more details as we approach approval and complete the regulatory process.
Q: How did the negative channel mix shift for YUPELRI occur, and how can it be reversed?
A: Rhonda Farnum, Chief Business Officer: The fulfillment dynamics are complex and involve various channels such as retail, long-term care, and hospital. We aim to ensure patients have the best access possible, and Viatris is working on corrective measures to improve the pricing dynamics.
Q: What gives you confidence that YUPELRI's revenue can grow in 2025 despite recent pricing issues?
A: Rhonda Farnum, Chief Business Officer: Continued demand growth is key, and Viatris has taken actions to improve pricing dynamics. We expect these measures to result in revenue growth in 2025.
Q: Can you elaborate on the updated timeline for the CYPRESS study and the factors affecting patient enrollment?
A: Aine Miller, Head of Development: We now expect to complete enrollment in the open-label portion of the CYPRESS study by mid-2025, with top-line data expected approximately six months later. The study design includes a 12-week open-label period followed by an 8-week randomized withdrawal, requiring sufficient patient progression to achieve 60 evaluable patients.
Q: How does the channel mix affect YUPELRI's pricing?
A: Rhonda Farnum, Chief Business Officer: The channel mix involves varied discounting across different channels such as retail, long-term care, and hospital. The fulfillment dynamics within these channels impact the overall pricing.
Q: What is the expected timeline for the top-line data release for the CYPRESS study?
A: Rick Winningham, CEO: The top-line data for the CYPRESS study is expected approximately six months after completing enrollment in the open-label portion, which is now anticipated by mid-2025.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
