Urovant Sciences Ltd (NASDAQ:UROV) Q4 2018 Earnings Conference Call - Final Transcript

Jun 13, 2019 • 04:30 pm ET


Urovant Sciences Ltd (NASDAQ:UROV) Q4 2018 Earnings Conference Call - Final Transcript


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Ladies and gentlemen, thank you for standing by. Welcome to the Urovant Sciences Fiscal 2018 Fourth Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following managements prepared remarks, we will odd a question-and-answer session. (Operator Instructions) As a reminder, today's conference is being recorded.

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

Christine Ocampo

Thank you. It is my pleasure to welcome you to our conference call to discuss our financial and operating results for the fiscal 2018 fourth quarter. I am joined today by several members of our leadership team; including Keith Katkin, our Chief Executive Officer; Dr. Cornelia Haag-Molkenteller, our Chief Medical Officer, and Michael McFadden, our Chief Commercial Officer.

After the close of market today, Urovant issued a press release containing detailed information on results. You may access this 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 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 February 2019 as well as the Form 10-K, which will be filed with the SEC in the near-term for a review of the various risks and uncertainties that could cause actual results to differ materially from projections.

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

Keith Katkin

Thank you, Christine and my thanks to all of you for joining us today. The fourth fiscal quarter marked a pivotal time for Urovant with the achievement of key milestones across our business, moving us closer to developing Urovant into a leading specialty urology company. In March, we announced positive topline data results from our pivotal Phase 3 EMPOWUR study of vibegron in patients with overactive bladder, in which vibegron met both co-primary endpoints, as well as all seven key secondary endpoints.

We believe the EMPOWUR Phase 3 study positions vibegron, if approved by the FDA, to be a best-in-class beta-3 agonist and potentially a best-in-class, a best-in-category oral OAB treatment. This belief is supported by the early launch success of vibegron in Japan.

March was also a milestone month for the COURAGE study with the first patient enrolled in the pivotal Phase 3 trial vibegron in men with OAB and BPH, an important supplemental program for vibegron given there is currently no approved treatment for the concomitant OAB and BPH. Additionally, the Phase 2a trial for vibegron for IBS-related abdominal pain which was initiated in December 2018 also continues to enroll well with topline results expected in 2020.

Furthermore, during the past quarter, we gained alignment with the FDA on the proposed Phase 2a protocol for our novel gene therapy product for OAB, URO-902. And finally to further our cash runway, we secured a debt finance agreement with Hercules