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

Jeff Bova: Sure. I think the three pieces of data, actually four are going to drive greater adoption in 2023. I’ll start with the operational data that we have that the FDA approved an eight to 96-hour stability period that’s already resulted in 50% of doses being delivered day prior. So we’ve been able to reengage physicians that may have been a little reluctant to adopt JELMYTO because of the eight-hour restriction. The second is certainly the question on long-term follow-up. How long do patients stay disease free? And we’ve been able to from the OLYMPUS data follows a number of those patients where we see the median at 29 months. That’s although the number is follow-up is a little bit smaller, that’s pretty €“ that’s very significant.

When physicians question or wonder, well, OLYMPUS gave us 12 months upon approval, but now we see long-term follow-up with the median of 29 months. I think more importantly, the two pieces, the real world evidence talks about how physicians really practice and that’s going to be key. And to go in and be a partner with multimodal what we use the term multimodal, be a partner with endoscopic resection. And so for those physicians that may have only been resecting and holding off on using JELMYTO, you’ll be able to go in and talk about the difference in CR, when I say the €“ you the representatives will be able to get in and talk about the difference in CR, the increase in CR. And then finally the Dr. Rose paper with 32 patients showing only a 9% stenosis rate with integrated administration versus the 44% that we saw in OLYMPUS.

So all of those key pieces of data give me confidence to that we’re going to see growth in 2023 from that.

Liz Barrett: I think €“ it’s Liz. I’ll just add one more comment around the 96 hours. The other thing that 96 hours does for us is it actually frees up our rep. Because in a lot of cases, when you only had eight hours, the rep had to make sure that the dose got to the doctor’s office on time or the hospital or wherever it was going. And now that we have more time, they don’t have to worry about that. And so that’s actually very helpful. So they can spend their time actually out generating more patients and generating demand versus really babysitting the dose to make sure it gets to the doctor’s office. But thanks for the questions.

Unidentified Analyst: Thank you.

Operator: And thank you. And one moment for our next question. And our next question comes from Boris Peaker from TD Cowen. Your line is now open.

Unidentified Analyst: Great, thanks. This is Nick on for Boris. I just have a quick question, or quick two questions on the ATLAS trial. Will you be releasing the TURBT patient data from ATLAS? I know that you’re planning to release about 280 patients worth of data. Does that include TURBT? And then also from the UGN-102 arm of the ATLAS trial, will this will allow for a potential read through to the ENVISION trial?

Liz Barrett: Mark, do you want to give your perspective and then I’ll add any commentary.