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

Aug 13, 2019 • 04:30 pm ET


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


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Ladies and gentlemen, thank you for standing by. Welcome to the Urovant Sciences Fiscal 2019 First Quarter Financial Results Conference Call. [Operator Instructions] Following management's prepared remarks, we will hold a question-and-answer session. [Operator Instructions]

I'd now like to turn the call over to Christine Ocampo, Chief Accounting Officer. Please go ahead. Ms. Ocampo.

Christine G. Ocampo

Thank you. It is my pleasure to welcome you to our conference call to discuss our financial and operating results for the fiscal 2019 first quarter. I'm joined today by two members of our leadership team, Keith Katkin, our Chief Executive Officer; and Dr. Cornelia Haag-Molkenteller, our Chief Medical 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 and other treatments 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 Form 10-K, which was filed in June 2019, as well as the Form 10-Q, which will be filed this week for a review of the 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.

Keith A. Katkin

Thank you, Christine, and my thanks to all of you for joining us today. Over the past three months, we've made significant progress across all of our programs, including the preparation of our NDA filing of vibegron. Importantly, today we announced that our ambulatory blood pressure study was successful and achieved its primary endpoint measure, which Cornelia will discuss in more detail later in this call. These results further support the safety and tolerability of vibegron and will be an important part of the vibegron NDA. We also had a very productive pre-NDA meeting with the FDA and continue to make excellent progress with the goal of filing the NDA by early 2020.

Other important business highlights include, in May, we presented the positive top line results from the pivotal Phase 3 EMPOWUR study of vibegron in patient's overactive bladder at the annual AUA meeting. We are now looking forward to presenting vibegron's positive clinical outcomes in more detail at the International Continence Society meeting in Sweden in September. Regarding the future commercialization of vibegron, we are pleased to see that the beta-3 agonist market share continues to increase with a 19% growth in the first half of 2019 compared with the same period in 2018. In addition, the overall OAB market is growing at approximately 2% year-over-year. We believe that the continued adoption of the beta-3 agonist mechanism of action is a strong benefit for vibegron commercialization given that there is no need to educate on a new class of therapy.

Regarding other clinical programs, we completed enrollment in part one of the Phase 3 study of vibegron in men with OAB and BPH.