UroGen Pharma Ltd. (NASDAQ:URGN) Q2 2023 Earnings Call Transcript

Liz Barrett: Yes, I think having said that, though, we do expect that there will be an increase in the field. It’s just much smaller than you might expect, obviously, for a big opportunity like UGN-102. But we would add some territories just from a physical and geographical perspective. And as Jeff mentioned, a lot of the other leverages that we can do we absolutely will do, but there will be incremental expenses for launching UGN-102.

Leland Gershell: And actually another quick question that comes to mind there is with respect to the premixing task for many community or urologist that’s something that’s done by third parties. I know you have a number of kind of agreements or you’ve established that that facility for various practices. How should we think about the need for increased coverage across the urological practice base for premixing needs, and would that have any impact on your spend?

Jeff Bova: Like JELMYTO, we have a mixed option for those community accounts that don’t prefer to mix. We will do the same. We are looking at either a JELMYTO like model or a all mix just so everyone would receive the product mix. Obviously, yes, there are incurred expenses but there’s also operational efficiency, there’s not training that’s needed to mix. The stability we believe will be long enough that we can deliver the product on Monday, they can keep it and administer it anytime during that week. And we’re evaluating that decision now. What we won’t do is require folks to mix everyone to mix this. It’ll either be very similar to JELMYTO or a 100% deliberate mix.

Operator: The next question comes from the line of Matt Kaplan of Ladenburg Thalmann.

Matt Kaplan: I guess just going back a little bit, based on the comments at the recent KOL day by some of the panel members. How do you think given the strength of the 102 data and their enthusiasm for it, how do you think it will be utilized in the treatment of an MIBC, especially given the ongoing BCG shortage?

Mark Schoenberg: So I think, obviously, our data have focused on patients with intermediate risk low grade pathology. So my expectation would be after approval that the indication would be in patients who have new and recurrent intermediate risk disease. Having said that, obviously, we’ve seen in the JELMYTO experience, I think, exemplifies this that once physicians have a new tool available to them, they can be creative in their management of patients. Obviously, that would in the setting of patients who are appropriate for treatment with BCG entail off-label use in high grade histology, which we obviously could not and would not promote. But my expectation is that the lion’s share of use would be for the indication, namely for low grade intermediate risk disease, either de novo disease or recurrent disease. And Liz may want to comment on this as well.

Liz Barrett: Yes, I guess I’ll just add to Mark’s point. We obviously in no way would promote for high grade disease. I think the ongoing shortage of the BCG just underlines the need for more treatments. And I think one of the things that we’re considering is now with the data being so strong, do we study UGN-102 in high grade disease, where else do we study UGN-102. I think we have a lot of opportunity and a lot of ideas on where we can take it next. There’s still, again, a high unmet need in this space. But I think from Mark’s perspective, I think you’ll see it really in the intermediate risk patient population in which we study.

Matt Kaplan: And just one quick question for Jeff perhaps. I guess, the learnings from the JELMYTO commercialization, which you think can be applied to UGN-102 once approved to help facilitate the ramp of that uptake?