Urovant Sciences Ltd (NASDAQ:UROV) Q1 2019 Earnings Conference Call Transcript

Aug 13, 2019 • 04:30 pm ET

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Urovant Sciences Ltd (NASDAQ:UROV) Q1 2019 Earnings Conference Call Transcript

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Q & A
Operator
Operator

Thank you. [Operator Instructions] Our first question comes from the line of Ritu Baral of Cowen. Your line is open.

Analyst
Ritu Baral

Good afternoon, everyone. Thanks for taking the question. Keith, can you remind us what's left before you can file the NDA application, now that the ambulatory blood pressure data is all in. Do you have any outstanding safety experience left to collect, anything left on CMC? And then I've got a follow-up.

Executive
Keith A. Katkin

Sure. Thanks, Ritu. So as it relates to what we need for the NDA filing, we have mostly everything we need. Importantly, we still need the double blind extension study results. So that was a 40-week double blind extension of the original Phase 3 EMPOWUR. We expect that we'll have those results available in September. And then the only other component we need is, we just need our 12-month stability data for the program and that data is expected in December. Thus, we'll work once we get that data to file the NDA as quickly as possible post receipt of the disability data.

Analyst
Ritu Baral

Got it. And the 40-week extension with the efficacy component of that going to be supportive of the efficacy package or is that safety alone? And how do you plan on releasing that?

Executive
Keith A. Katkin

Yeah. So certainly we'll release that either like we did with the ambulatory blood pressure study as part of an earnings call or separately. For the study, obviously, the safety is of paramount importance just to be able to demonstrate the continued safety over a full 52-week treatment period. We do have efficacy measures in the study as well. However, there is no placebo as a reminder, the extension study is just vibegron and tolterodine so any comparisons that we'll be looking at will just be numeric comparisons from an efficacy perspective.

Analyst
Ritu Baral

So the key there, as you just look at durability and effect on OAB measures?

Executive
Keith A. Katkin

Exactly. I mean, ideally we'd want to see results similar to what we saw in the Merck Phase 2 long-term extension study in which efficacy was maintained over the entire time period or even slightly improved with a performance that is numerically better than tolterodine.

Analyst
Ritu Baral

Got it. And my follow-up is on, basically what we're seeing out there about potentially increased awareness, the increased focus on the dementia risk associated with anticholinergic medication. Can you talk about whether that's shown up on your most recent market research and if you've done any work on the awareness of that in the urologists community?

Executive
Keith A. Katkin

So, yes, we have done work. The work that we have done perceived all of the recent news pickups. You may have seen it on CBS News, USA Today, we've got a late journal article coming out. But what I can tell you is that prior research that we did earlier this year, there is very low awareness from particularly patients that obviously -- almost no awareness. And from the clinician perspective, small percentage of doctors have heard something, but they didn't know exactly