Theravance Biopharma, Inc. (NASDAQ:TBPH) Q4 2023 Earnings Call Transcript

Rick Winningham: So, on the ampreloxetine, obviously, we are — we’ve initiated a lot of sites, as Aine hit on her comments, high quality sites with physicians who understand MSA patients, understand the care of MSA patients and understand the execution of the clinical trial. We’ll continue to activate sites and there is some work that’s necessary there, but the more and more work, obviously, is focused on just getting patients into and through the sites for the study. We’re making very good progress there and I think if you split that, we got this is really about — is a little bit tilted towards patients as opposed to sites and that’s where our focus will be. In terms of where the study is, I think, we’ll enroll our target, and right now, that’s what we believe we can do is enroll the last patient into the open label portion in the second half of the year.

This would mean data probably sometime in the first half of next year and that’s what we’d be looking forward to, but stay tuned as we progress throughout the year. I think, the — at least from the science and the medicine part of ampreloxetine and the value that it can provide for patients with MSA and nOH, I think, hopefully, our investor event that we have in the second quarter will be able to provide good information to investors about the opportunity that we see there.

David Risinger: Great. Thank you very much.

Rick Winningham: Yeah. Thanks, David.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Eva Privitera from Cowen. Your question, please.

Eva Privitera: Hi, guys. Congrats on the great quarter and thanks for taking our questions. I have a question about the Q2 investor event for ampreloxetine. Will there be any additional analyses that we haven’t seen before?

Rick Winningham: Yeah. Thanks, Eva. I think, relative to ampreloxetine, I think, the additional analysis will be relatively limited. I think, as we mentioned, we will have opinion leaders there that present other analyses, obviously, of both nOH and MSA patients as part of their presentation that outline the medical need and the opportunity that ampreloxetine has to meet that medical need through the data that they have and that is currently published, but certainly consolidating it into one particular event.

Eva Privitera: Got it. That’s helpful. And another one from me. How should we think about ampreloxetine’s market opportunity relative to NORTHERA, which I believe achieved $400 million in peak sales, given all of NORTHERA’s shortcomings and ampreloxetine’s differentiation, how much bigger could ampreloxetine be?

Rick Winningham: Well, I think, very — we’re optimistic on ampreloxetine. That’s one of the reasons why we focused on, both in my comments, as well as Aine’s comments, on patient populations and the fact that there really is no solution that’s adequate out there for patients that have MSA and nOH. But in a population of 40,000 patients with MSA and nOH, and given that, as Aine presented, this is, in fact, a debilitating condition that keeps many of them really unable to interact with their environment, I think, that being able to show, among multiple different parameters as measured by the OHSA composite score, that we improve the well-being of these patients I should — I think should open up a significant opportunity for us.

And as a reminder, we get — we were granted orphan drug designation. This is an orphan drug for a rare disease. So we’re quite excited about, obviously, continuing to progress with the study, the investor event that we have in quarter two, which I think will fill in some more information and then continue to provide additional information as we work towards closing the study and data, so.

Eva Privitera: Perfect. Thank you. Congrats again.

Operator: Thank you. One moment for our next question. And our next question comes from the line of Julian Harrison from BTIG. Your question, please.

Julian Harrison: Hi. Congrats on the quarter and thank you for taking my questions. It was great to see a positive outcome from your Phase 3 trial of YUPELRI in China back in November. I’m wondering if you could remind us about how you’re thinking about the China market opportunity there and what are the gating steps to filing later this year. And then on CYPRESS, do you have a good sense now for what the U.S., ex-U.S. enrollment split will likely look like? Any big differences there relative to the 170 Study? Thank you.

Rick Winningham: Rhonda, you want to comment on China, and then Aine, maybe give just a high level comment on U.S. and non-U.S. on CYPRESS? Rhonda first.

Rhonda Farnum: Yes. Thanks, Julian, for the question and recognizing the positive outcome of that Phase 3 that Viatris completed. So they will be continuing to prepare, and as they’ve indicated, will be striving to make that filing for the application by the midpoint of this year. And in thinking about the market for YUPELRI, we haven’t made an outwardly communication around an absolute market projection, and just thinking about, certainly, it’s a very significant financial burden on that healthcare system, not too dissimilar from the U.S. We can ensure that we continue to evaluate what that opportunity can be for YUPELRI.

Rick Winningham: Yeah. And I think, just to add to that, Julian, Viatris will be commercializing the medicine in China. They have a substantial organization in China, which is one of the reasons that we licensed YUPELRI to them in China. I think that, they’ve — since it is sort of their commercial responsibility, they have, I think, their calls coming up, and you may get some, ask a question of them on opportunity. But, obviously, the China market and COPD is very, very large, and it’s about capturing as much of that opportunity as really makes economic sense.

Rhonda Farnum: Julian, just to give you some fact bases for the China market itself, COPD affects about 100 million patients in that marketplace and a significant roughly 40% of those patients are moderate to very severe patients suffering with COPD. So as you can think about that relative to that being the focus for us here in the U.S., I think that can give you some estimates.

Aziz Sawaf: Julian, hey, it’s Aziz. Thanks for the question. One additional point in our 10-K, which we’ll file in a couple days now, we’re going to be actually disclosing the YUPELRI economics for both the U.S. sales milestones and the China milestones and royalty rates in more detail. So we’ll actually break out the sales milestones, and you can see, for the first time, we broke out the actual percentage of the royalties 14% to 20%. So a pretty significant royalty in a huge market, obviously. So we’re really excited about the opportunity and the economics there.

Julian Harrison: Excellent.

Rick Winningham: Aine, do you want to talk about ampreloxetine?