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

Boris Peaker: First question is on the ATLAS study. Obviously, we saw very impressive data there. I’m curious if you’ve had any interactions with the FDA to discuss whether or not that could be the basis of a pivotal study potentially allowing you to file earlier than waiting out for ENVISION?

Liz Barrett: We have not as of yet had conversations with the FDA, we will be requesting a meeting with them and how long the FDA takes, so it takes them 60 days to award us a meeting. And so as soon as we can talk to them, we will talk to them. I think the base case and what I think we should expect from the FDA based on the conversations we had with them is that they’re going to want to see durability in ENVISION. We feel very confident given the — not only the OPTIMA data but the durability in ATLAS. We feel very confident about the durability but the FDA has been very clear all along that durability is very important. So we will talk to them about to see if there’s any wiggle room from a timing standpoint. But at this point in time, I think it’s fair to say that we’re sticking with our current timeline as far as the FDA is concerned.

Boris Peaker: My second question is, can you just outline what exactly is the formulation difference between JELMYTO and 102? And I guess the purpose of the question is just to get a sense of can 102, once approved, be used in place of JELMYTO?

Liz Barrett: Mark, can you talk about that and why that’s — it can’t be interchanged, but the differences in them?

Mark Schoenberg: So there are some very specific differences. The first of which is 102 is a much larger volume with a lower concentration of mitomycin per CC compared to JELMYTO. So I think it’s important to understand that while both are efficacious different doses of medication are actually delivered by the different medications, they are not interchangeable and 102 would not be an acceptable agent for use in the upper urinary tract based on our published data.

Operator: Our next question comes from the line of Leland Gershell of Oppenheimer.

Leland Gershell: Couple from me. First, I know it’s a little bit early, but would you expect that the data section of the 102 label, therefore, to feature both the full complement of the ATLAS and ENVISION data? And secondly, as we think about operating expense for the company going forward, clearly, lots of overlap here with the existing commercial infrastructure. You mentioned 95% overlap in prescriber base. What should we contemplate for modeling purposes as we think about what additional expense UroGen may need to incur as the company expands its scope to be selling 102?

Liz Barrett: I think we don’t know but we would expect all of the data to be in the label, just obviously in the clinical trial section of the label, if nowhere else. But we obviously will have those discussions with the FDA, to your point, it’s early. But I don’t see any reason why that data would not be included. I’m just going to ask Jeff to comment on expenses from a standpoint of launching UGN-102 and the leverage ability across with JELMYTO. So Jeff?

Jeff Bova: So yes, obviously, with the 95% overlap, you could also say 100% overlap with wherever we would be conference wise for JELMYTO, we will be there for 102. Obviously, we’ll build in launch expenses but the synergies, for meetings, for conferences, for other events, for the overlap and the targets, I don’t see a significant expansion in the field. Because of the overlap in the targets, we will adequately prepare for a strong launch with 102. But yes, there are significant synergies that we can take from JELMYTO.