UroGen Pharma Ltd. (NASDAQ:URGN) Q3 2023 Earnings Call Transcript

Boris Peaker: Great. And my last question here. You mentioned reimbursement economics that the -102 is more favorable than TURBT. Can you just talk about what those reimbursement economics are in various settings, maybe in academic centers versus private practices or however you want to divide that?

Elizabeth Barrett: Yes, sure. Jeff, we’ll take you through that.

Jeffrey Bova: Boris, yes, so depending on the size of the tumor for TURBT, there isn’t a significant amount that’s reimbursed to the physician. I do think there’s maybe a perception that it’s larger than what it is. But if you were to look at the reimbursement economics, and you couple in insulation of an anti carcinogenic, which would be UGN-102 times as well as the buy-and-bill portion of the drug, which will be given in the clinic predominantly. So the physician would see that buy-and-bill versus a hospital. The economics look very good when compared to TURBT. I don’t — people need to understand that surgeries or reimbursement [indiscernible] has gone down, and we see that as evidence of a TURBT, obviously depends on the size of the tumor. But overall, the reimbursement, we expect -102 to be better than TURBT.

Elizabeth Barrett: Yes. And then look, the only thing I’ll comment about is we are not going out with a profitability message, right? That’s not our message. We can’t do that. We won’t do that but it will be very right. It will be very important to them, that they don’t feel like they’re losing money that is not a detriment to them, even though we know it’s better medicine for the patient, which we will focus on. But we do have field reimbursement managers. We will make sure that our reps are also armed and able to share the information that we can appropriately share because it is an important piece, as you know. Unfortunately, decisions get made that way. But this is — will be, frankly, a net positive if they did from a financial standpoint. But keep in mind, obviously, our role in how we discuss that to the marketplace.

Operator: And our next question comes from Paul Choi from Goldman Sachs.

Paul Choi: Congrats on the good quarter. I was just wondering for Mark, if you could maybe share any additional feedback you’ve had from the physician community since Investor Day, specifically, since the Society of Urologic Oncology is coming up here, any additional feedback you’ve gotten on ENVISION and ATLAS?

Mark Schoenberg: Paul, thanks for the question. And I may actually lean on Jeff as well to talk about this. But I think people are excited about the possibility of the approval of -102. I think everybody — specifically folks who work in urologic oncology understand the need and specifically the unmet needs population. So what I’m hearing from colleagues is anticipation that’s positive. But Jeff, I don’t know if you have additional…

Elizabeth Barrett: You want to talk about what some of the feedback you got at LUGPA?

Jeffrey Bova: Sure. So we just got back, Paul, from LUGPA’s Annual Meeting, the larger groups. We had an advisory board there. where Dr. Prasad presented some of the data that we saw out of day. And I think the initial reaction was overwhelmingly positive. It was designed to sort of get their feedback in and around the data. We workshopped a couple of different patient types, but they’re eager to have a different option. If you on the conservative side of things, they certainly have a number of patients that they do not want to put under general again and have a surgery. So there’s that. And then many of them reiterated that essentially what looks like at least in ATLAS, it’s the same for TURBT and it’s a much longer duration of response which is obviously, a key attribute, if approved, for UGN-102.

So that was 12, 13 advisers, very influential in the community that gave us really strong feedback. We’ll continue to obviously engage as we need that feedback, but that was just an initial reaction.

Boris Peaker: And as a follow-up also for you, Jeff. Just regarding your comments on the buy-and-bill process. Can you maybe just give us some sense of what you think the runway will be before reimbursement? And J-Codes and so forth are established for -102 and just how you think the early mechanics might look like starting with the launch in 2025?

Jeffrey Bova: Sure. As with any Part B drug, you will have — we will have a miscellaneous code for a period of time. We did with JELMYTO. We expect that with 102 — as with any miscellaneous code, it’s a manual process. So we have to really make sure that we’re buttoned up on making sure that we support the office on how they fill everything out correctly with that miscellaneous code. I will say this, it will be clearer than JELMYTO because with JELMYTO, you had to build for both drug and waste. So you had a miscellaneous drug code. You had a miscellaneous waste code. Here, you won’t have as many line items. So it will be much more straightforward. We will put things in place to sort of help with the anxiety in and around a miscellaneous code.

We expect, if approved, in the time line that we think we’re going to get. The nice thing is CMS is reviewing miscellaneous codes more than once a year now. So we expect the J-Code hopefully sooner because of that review process. But we will put those — play things in place to get past that. But I always say it’s a miscellaneous code. It takes a little bit more time on the physician — the physician practice. You’ll have your early adopters that will come out and use it and hopefully, be reimbursed accurately and they can then share that they’ll talk to their peers. And then hopefully, by then, we have a permanent J-Code.