Urovant Sciences Ltd (NASDAQ:UROV) Q3 2018 Earnings Conference Call Transcript

Feb 13, 2019 • 04:30 pm ET

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Urovant Sciences Ltd (NASDAQ:UROV) Q3 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Hello, and welcome to the Urovant Sciences Third Quarter 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, this conference is being recorded.

And I now like to introduce your host for today's call, Christine Ocampo. You may begin.

Executive
Christine Ocampo

Thank you, Towanda. It is my pleasure to welcome you to our conference call to discuss our financial and operating results for the fiscal 2018 third quarter. I am joined today by several members of our leadership team; including Keith Katkin, Chief Executive Officer; Dr. Cornelia Haag-Molkenteller, Chief Medical Officer and Michael McFadden, Chief Commercial Officer. After the close of market today, Urovant issued a press release containing detailed information on results. You may access the release on our Company website, urovant.com.

Today's remarks contain forward-looking statements, including statements regarding our plans and strategies for the clinical development of vibegron, another treatment for urologic diseases. I direct your attention to the forward-looking statements disclosure in today's press release and the Risk Factor section of the quarterly report on Form 10-Q, which was filed with the SEC in November 2018 as well as the Form 10-Q, which will be filed with the SEC by tomorrow. For a review of various risks and uncertainties that could cause actual results to differ materially from projections.

With that said, I'll turn the call over to our CEO, Keith Katkin.

Executive
Keith Katkin

Thank you, Christine and my thanks to each of you for joining us today. The third fiscal quarter was a productive quarter as we continued to advance key clinical programs. We were pleased that we made significant progress across all of our development programs. In November we completed enrollment in our international Phase III trial for vibegron called the EMPOWUR Study and we expect topline data by the end of March 2019. In December we initiated enrollment in the Phase IIa program for vibegron for IBS-related abdominal pain. We were pleased to reach this milestone by the end of 2018. In January we gained alignment with the FDA to our trial protocol for a pivotal Phase III study for vibegron in men with overactive bladder and benign prostatic hyperplasia. This is an important supplemental program for vibegron as there are currently no approved treatments for men with concomitant OAB and BPH. Also in January, we submitted a request to the FDA to discuss the development of a Phase IIa study for a novel gene therapy URO-902, which was previously called hMaxi-K. And finally, we presented our clinical programs in view of a commercial opportunity in urology at our first Research and Development Day held last week in New York City. A replay of that event is available on the Urovant website.

With that, I will turn the call over to our Chief Medical Officer, Dr. Cornelia Haag-Molkenteller, who will provide more detail on our clinical programs, Cornelia?

Executive
Cornelia Haag-Molkenteller

Thank you, Keith. First, I would