UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2022 Earnings Call Transcript

Jeff Bova: Sure. So, hi Mitchell. The main driver continues to be patient identification getting into the offices and really sitting down and looking at various codes that help identify patients that could benefit from JELMYTO. But we €“ the data to continue to get better, we continue to do that. And then, physicians, as you saw from the number that increase from repeat users, they also, once they get experience, they also look for other patients in the practice. We, obviously, have this data will be out there in the hands of the field. So prior to Q4 that we just reported this data wasn’t available. So we’re certainly excited about the pieces of data, the long-term follow-up, Woldu which is the retrospective as well as the Rose paper which talks about additional integrated installations to continue to help us with get in new data is always a positive.

It allows access. Physicians are going to be very, and have been very interested in hearing about the new data since the real world is evidence is really how they’re using JELMYTO, which as you can see is oftentimes endoscopic resection, getting what they can see, understanding that there’s microscopic disease that they couldn’t see, and coming back with six doses of JELMYTO.

Liz Barrett: And on the ex-U.S. question, I think we €“ as we’ve talked about before, the challenge with ex-U.S. isn’t getting an approval on the data we have today. It’s really getting reimbursement. So for a market like Europe, for us to get reimbursement at a decent rate, that’s viable for us or a partner to go in there. We really need to do another study. And so because we prioritize the work that we’re doing here in the U.S. for obvious reasons. So we see that down the road, but we absolutely see an opportunity to do more clinical work that would get us, global €“ give patients frankly global access. And right now we do have a Named Patient Program. We actually have had a lot of success with a few patients, that have had good results after using it through the Named Patient Program because one piece of actually getting governments to pay is when physicians start asking for it.

So with a Named Patient Program and them getting some experience with that and their ability to be able to get access to it. So, right now we’re really focused on the U.S. and making sure we’re bringing 102, but we know what it would take to do something. And it would require another study outside the U.S.

Mitchell Kapoor: Okay. And then, yes, and on 102, just wanted to ask, if the commercial strategy will require any additional infrastructure in the U.S.?

Liz Barrett: Yes, Jeff, do you want to just talk about sort of thoughts around that.

Jeff Bova: Sure. There’s a 95% overlap in key targets. It will not require a significant resource expansion. We’ll always take a look at larger geographies to cut down on windshield time. But because the overlap is so significant, I don’t see a reason for a larger major expansion with the hopeful approval of 102.

Mitchell Kapoor: Okay. Great. Thank you all.

Operator: And thank you. And one moment for our next question. And our next question comes from Paul Choi from Goldman Sachs. Your line is now open.

Unidentified Analyst: Hi, this is Roderick for Paul Choi. Thanks for taking our questions. So the first question is, what could drive further adoption of JELMYTO in 2023 and maybe potentially reach the higher end of your guidance? And maybe another question is in 2023 to anticipate to report additional real world data, including maybe the physician’s feedback based on the stability change in the label in this year? Thanks.

Liz Barrett: Jeff?