Theravance Biopharma, Inc. Q1 FY2025 earnings call

YUPELRI Performance - Strong Q1 results with 6% sales growth, driven by demand, pricing, and channel mix. - Hospital volume reached a record high of approximately 316,000 units, up 48% year over year. - Future potential with market research supporting demand growth and a sizable remaining addressable patient population. ### Trelegy - GSK's Q1 sales up 14% year over year, on track for the $50 million milestone. - Confidence in achieving up to $150 million in milestones from 2025-2026. ### Ampreloxetine - Progress in phase three Sypris trial, nearing completion of open-label enrollment with top-line data expected in 6 months. - Making excellent progress on key modules of the NDA, with plans for an expedited regulatory submission and Priority Review. ### Financials - Collaboration revenue $15.4 million, up 6% year over year. - YUPELRI brand level cash profitability grew faster than collaboration revenue. - Operating expenses increased, driven by R&D (Cypress patient enrollment, NDA/regulatory activity) and SG&A (ampreloxetine prelaunch initiatives).

YUPELRI: Net sales increased 6% to just over $58 million in the quarter, driven by demand growth, favorable pricing, and channel mix. Hospital doses increased 48% year on year. Trelegy: GSK reported $854 million in sales in Q1, up 14% year over year, placing Theravance Biopharma on pace to achieve the $50 million milestone in 2025.

• Reaffirming 2025 financial guidance. - Anticipated decline in R&D clinical trial costs in H2, flat or slightly lower SG&A. - Expecting improvement in recurring non-GAAP loss and cash burn, except for one-time tax payment in Q2 due to TRELEGY milestone. - Trelegy on track for $50 million milestone, with confidence in achieving higher end of $150 million in 2025-2026.

• Potential impact of future policies or trade developments on ampreloxetine, though currently no material impact expected.

Q: Maybe one kind of on ampreloxetine, then and then I'll have a follow-up on the commercial performance for Rhonda. To start on the manufacturing side, I appreciate your comments that you have some time before the NDA is even filed, let alone launching the product in the US. So you have some time to maybe adjust to whatever policies may come out. Can you just give us a status update of, like, where the current plan for manufacturing is in terms of locations and then where the IP resides? Is it in Ireland, or has that already been placed in the United States?

A: Yeah. Thanks, Marc, for the question. Yeah. The IP for ampreloxetine currently is in Ireland. Manufacturing of the API is outside the United States, in Taiwan. So we will obviously, we've got a lot of time to adjust what you know, where supplies are, etcetera. But we feel pretty good about you know, where we are right now and the flexibility that we've got.

Q: Hi. This is Ria on for Julian. Thank you for taking our question. Just a couple for us. First, on ampreloxetine. Have you received any feedback yet from payers on ampreloxetine and nOH, or is that something that likely occurs after top-line data from Cyprus? And if, like, on that point, what endpoints do you expect payers to be most receptive to?

A: Yes. Thanks, Ria, for the question. As you would likely anticipate, we have started engagement with payers to ensure not only they have an appreciation of the significant need and the burden this disease has on patients so that they fully appreciate what role a therapy like ampreloxetine can serve in this patient population. And we're working very closely to ensure that on the endpoint and likely scenarios of data input from the study readout itself. The messaging, and their reaction and questioning and additional educational support that they may need. In a post-approval situation that they are armed with the right details and support. So we're definitely very active in space now, but, obviously, we've got a bit of time to ensure that we have that segment and critical element in access set up.

Q: Got it. Thank you. And if I could ask one on YUPELRI, could you provide us with an update on the paragraph four filers? Have settlements been reached for all parties?

A: Yeah. Sure. We've settled with five of the eight filers. We have three outstanding litigants. Really no other update other than outside of that.