UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2023 Earnings Call Transcript

Elizabeth Barrett: Yes. What we’ve — when we spoke to the FDA about it, they felt like they were different enough that we needed a clinical study. And as we’ve said in the past, we actually think that’s good news because if we have to do it, so will others, right? And that’s part of our strategy around any other company trying to come in, into our space. So we feel really good about that, but what we have discussed with the FDA and we’ll continue to align with them is that it needs to show efficacy — safety and efficacy and durability. But they want to see results consistent, but we don’t have to have the same timeline. So the 102 study will be probably around 85 patients. So if you think about ENVISION at 220 patients where we ended up with 240 patients, we only have to do an 85 patient study and something smaller than that for UGN-104 for the next-generation JELMYTO formulation.

So maybe in the 50 to 60 patient perspective. We’re prioritizing UGN-102 for obvious reasons from a start perspective. And then the follow-up as well. So as long as the results are consistent, then the FDA is open to us filing on less data, but just showing consistency. And so that’s kind of where we are. So our expectation at this point is that we would have approval for both of those in the 2027 time period. So we feel really good about kind of where we are and our ability to get those approved, or get the J-Code for both of them and do an appropriate switch to the new formulation before taking the old formulations off the market.

Matt Kaplan: Okay. That’s really helpful. Thanks. Thanks Liz.

Operator: That concludes today’s question-and-answer session. I’d like to turn the call back to Liz Barrett for closing remarks.

Elizabeth Barrett: Yes, thanks, and thanks, everybody, for joining. I think everybody understands that this is a defining year for us at UroGen. We’re excited about the prospects and about preparing for UGN-102 on continuing to increase adoption of JELMYTO and we’re seeing nice events and nice data coming out of our registry and out of some investigator-initiated areas. So thanks. We’ll keep you guys posted as we — as things go along and really always appreciate your interest in our company. Thank you. Operator, you can disconnect now.