Theravance Biopharma, Inc. Q2 FY2025 earnings call

Management Statement and Operational Highlights

• Commercial Success: YUPELRI net sales at $66M, with growth driven by demand, pricing, and hospital channel performance. China approval of YUPELRI triggered a $7.5M milestone. Sale of TRELEGY royalty to GSK enhanced balance sheet.
• Ampreloxetine Progress: CYPRESS trial on track for enrollment completion soon, with top-line data expected ~6 months after. The trial's design leverages ampreloxetine's tailored mechanism to target MSA's nOH, with strong engagement from investigators, patients, and advocacy groups.
• Financials: Collaboration revenue grew 31% Y/Y due to YUPELRI sales, R&D and SG&A expenses in line, share-based comp decreased 16% Y/Y, ended Q2 with ~$340M cash, and non-GAAP losses improved compared to prior year.

Segment Performance

• Commercial Business (YUPELRI): Net sales for the quarter reached approximately $66 million, driven by demand growth, favorable net pricing, and strong pull-through in the hospital channel. YUPELRI received approval in China, triggering a $7.5 million milestone. The $225 million sale of remaining royalty interest in TRELEGY to GSK strengthened the balance sheet.
• Ampreloxetine: Phase III CYPRESS trial is on track to complete enrollment in the open-label portion over the next couple of weeks, with top-line data expected approximately 6 months after. The trial is designed to replicate the Study 170 MSA prespecified subgroup, targeting neurogenic orthostatic hypotension in MSA patients.
• TRELEGY: Strong second quarter performance increased the likelihood of receiving remaining $150 million in milestones from Royalty Pharma over the next 18 months. The $225 million sale of royalty interest to GSK significantly strengthened the balance sheet.

Guidance

• Reaffirmed 2025 financial guidance. Excluding onetime items, expects stronger second half due to underlying business performance and cost discipline. TRELEGY's strong performance increases likelihood of remaining $150 million in milestones from Royalty Pharma over the next 18 months.

Risks

• Actual results may differ from forward-looking statements due to various risk factors. Uncertainties in CYPRESS trial outcomes and market adoption challenges for ampreloxetine pose potential risks.

Question and Answer

Q: On YUPELRI pull-through and channel mix, what's the attribution and outlook for channel mix optimization?

A: Pull-through improvement is related to specialty pharmacy's better fulfillment and persistency. Channel mix optimization remains strategic, focusing on patient and provider education, with no specific timeline set yet.

Q: On YUPELRI China outlook and CYPRESS enrollment split?

A: Viatris leads China launch, with further details on market plan to be provided later. CYPRESS enrollment split is similar to prior study, with top-line data to be disclosed at readout.

Q: On ampreloxetine pricing and reimbursement?

A: Reference to rare disease drug launches suggests ~$380K per year average, with U.S. payers actively engaged, focusing on disease unmet need and data durability.

Q: On SG&A for ampreloxetine and post-CYPRESS outlook?

A: SG&A stable until CYPRESS data readout; post-readout, increased spend expected if data is positive, with targeted launch efforts.

Q: On YUPELRI operating leverage and ampreloxetine trial duration?

A: Operating leverage expected, but continued significant increases not anticipated. CYPRESS trial's 8-week randomized withdrawal design focuses on durability of ampreloxetine's benefit, differing from shorter durations of existing therapies.