Urovant Sciences Ltd (NASDAQ:UROV) Q3 2019 Earnings Conference Call - Final Transcript

Feb 13, 2020 • 04:30 pm ET

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Urovant Sciences Ltd (NASDAQ:UROV) Q3 2019 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Good day, ladies and gentlemen, and welcome to Urovant Fiscal Third Quarter 2019 Earnings. [Operator Instructions]

I would now like to turn the call over to Ryan Kubota. Sir, you may begin.

Executive
Ryan Kubota

Thank you, Fathi. Good afternoon and thank you all for joining Urovant fiscal 2019 third quarter financial results conference call. With me today are four members of our leadership team: Keith Katkin, Chief Executive Officer; Ajay Bansal, Chief Financial Officer; Dr. Cornelia Haag-Molkenteller, Chief Medical Officer; and Christine Ocampo, Chief Accounting Officer. Today after market close, we issued a press release containing detailed information on our quarterly results. You may access our release on our company website, urovant.com.

During our call, we will be making forward-looking statements, including statements regarding our plans and strategies for the clinical development of vibegron and other treatments for urologic diseases. Listeners are cautioned that all of our forward-looking statements are based on our current expectations and assumptions, which are subject to numerous risk factors that could cause our actual results to differ materially. Accordingly, we advise listeners to review the forward-looking statements disclosure in today's press release and the Risk Factors section of our Form 10-K, as well as our Form 10-Q, which we filed later today.

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

Executive
Keith A. Katkin

Thank you, Ryan. And my thanks for all of you for joining us this afternoon. This has been a very exciting and transformational quarter for Urovant marked by key milestones across all aspects of our business. First, in December, we submitted our new drug application to the US Food and Drug Administration for vibegron for the treatment of patients with overactive bladder. The submission comes one quarter earlier than we initially anticipated and we are very excited to have submitted our application by the end of the calendar year and ahead of schedule. Second, we initiated our Phase 2a study in URO-902, our novel gene therapy product for patients with overactive bladder suffering with urge urinary incontinence that have failed oral pharmacologic therapy. The study is evaluating URO-902's efficacy, safety and tolerability of a single administration of the product and we expect top-line safety data towards the end of the year.

Third, pursuant to the transaction between Sumitomo Dainippon Pharma also known as DSP and Roivant Sciences, DSP is now Urovant's majority shareholder. As part of the transaction, Urovant entered into a loan agreement with DSP, whereby DSP provided Urovant with a $300 million low interest, interest only five year term loan facility with no repayments due until the end of the term. This loan facility provides Urovant with capital well into 2021 and enabled us to pay back the outstanding amount on our previous loan agreement with Hercules Capital. DSP also expect to support Urovant through profitability and provide support for the commercialization of vibegron providing access to its US commercial infrastructure, including drug distribution, operations and managed care support.

Finally, Urovant and DSP entered into an investor rights agreement