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Edited Transcript of UROV.OQ earnings conference call or presentation 13-Aug-19 8:30pm GMT

Q1 2020 Urovant Sciences Ltd Earnings Call

Aug 21, 2019 (Thomson StreetEvents) -- Edited Transcript of Urovant Sciences Ltd earnings conference call or presentation Tuesday, August 13, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Christine G. Ocampo

Urovant Sciences Ltd. - Principal Financial & Accounting Officer

* Cornelia Haag-Molkenteller

Urovant Sciences Ltd. - Chief Medical Officer of USI

* Keith A. Katkin

Urovant Sciences Ltd. - CEO & Director

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Conference Call Participants

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* Biren N. Amin

Jefferies LLC, Research Division - MD and Senior Equity Research Analyst

* Edward D. Marks

H.C. Wainwright & Co, LLC, Research Division - Research Analyst

* Eric William Joseph

JP Morgan Chase & Co, Research Division - VP & Senior Analyst

* Joon So Lee

SunTrust Robinson Humphrey, Inc., Research Division - VP

* Ritu Subhalaksmi Baral

Cowen and Company, LLC, Research Division - MD & Senior Biotechnology Analyst

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Presentation

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Operator [1]

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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) 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.

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Christine G. Ocampo, Urovant Sciences Ltd. - Principal Financial & Accounting Officer [2]

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Thank you, Nicky. 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 2 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 Factors 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.

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [3]

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Thank you, Christine, and my thanks to all of you for joining us today. Over the past 3 months, we have 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 III EMPOWUR study of vibegron in patients with 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 there is no need to educate on a new class of therapy.

Regarding our other clinical programs, we completed enrollment in Part 1 of the Phase III study of vibegron in men with OAB and BPH. Assuming an acceptable safety profile, we'll then move into Part 2 of the study in the fourth quarter of this year, an important milestone given there is currently no approved treatment for concomitant OAB and BPH.

Additionally, the Phase IIa trial for vibegron for IBS-related abdominal pain continues to enroll on schedule, with results expected in 2020. And lastly, we have finalized the Phase IIa protocol for a novel gene therapy product for OAB, URO-902, and are preparing to start enrollment for that study by the end of the fourth quarter of this year.

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

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Cornelia Haag-Molkenteller, Urovant Sciences Ltd. - Chief Medical Officer of USI [4]

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Thank you, Keith. As mentioned, we continue to make excellent progress across all 4 of our clinical development programs. First, I will talk about the OAB program for vibegron. We continue to make great progress on the vibegron NDA filing. Following the positive top line results from the Phase III EMPOWUR study of 75-milligram vibegron for overactive bladder, we are now pleased to report that we've achieved the primary endpoint for the ambulatory blood pressure study. The purpose of the study was to rule out an effect of vibegron relative to placebo on daytime systolic blood pressure. The primary endpoint variable was the change from baseline to day 28 in mean daytime ambulatory systolic blood pressure. The protocol was reviewed by the FDA in the fall of 2018.

The protocol predesigned that for an effect of vibegron, a mean ambulatory systolic blood pressure to be ruled out, the upper limit of the 90% confidence interval had to be less than 3.5-millimeter mercury for the daytime ambulatory systolic blood pressure for vibegron compared to placebo. The study enrolled 214 subjects across 10 U.S. sites. In accordance with the FDA guidance, the study population had similar characteristics as the drug target population: men and women aged 40 to 75 years with OAB. This was a controlled study of 75-milligram versus placebo in a 1:1 randomization. The study was based on the 75-milligram vibegron dose planned for registration with the FDA. The duration of the study was 4 weeks, and ambulatory 24-hour blood pressure was measured at baseline and weeks 2 and 4.

Secondary endpoints were the change from baseline in mean daytime diastolic blood pressure and heart rate and the full 24-hour mean change in systolic and diastolic pressure and heart rates as well as the maximum changes 30 minutes to 6.5 hours post dosing. A total of 108 subjects were enrolled into the placebo group, 106 subjects into the vibegron treatment group. 76 of the subjects were female, and the mean age was 59 years. 97% of the subjects completed the study.

The results of the ambulatory blood pressure study are as follows. The primary study endpoint was achieved for vibegron. The vibegron minus placebo in square mean change for the daytime ambulatory blood pressure from baseline to day 28 was 0.81 millimeter mercury with a 90% confidence interval of minus 0.88 to plus 2.49. Therefore, the vibegron treatment group never crossed the upper bound of the predefined confidence interval of 3.5-millimeter mercury, making this a successful study as we ruled out a clinically relevant increase in systolic blood pressure of 3.5-millimeter mercury, as agreed with the FDA. The confidence interval includes 0, which indicates that the mean change from baseline in daytime ambulatory blood pressure is not statistically different from placebo.

For the full 24-hour ambulatory systolic blood pressure, the treatment differences from baseline to day 28 for vibegron over placebo were plus 0.57-millimeter mercury; for diastolic blood pressure, minus 0.19-millimeter mercury; and for the heart rate, plus 0.96 beats per minute. There was no statistically significant difference for vibegron compared to placebo in any of these endpoints or the primary endpoints.

Regarding the categorical changes from baseline, systolic blood pressure or the in-clinic visit vital signs, there were small, not clinically relevant increases in the percentage of patients having a 10-millimeter or 15-millimeter mercury increase in systolic blood pressure compared to placebo. This [resident] profile was consistent with the EMPOWUR Phase III study, with the most common adverse events being headache, diarrhea, upper respiratory tract infection and urinary tract infection at rates below 5%.

Regarding the adverse event of hypertension, there were 4 events in the placebo group and 5 in the vibegron group. Therefore, there was 1 event more in the vibegron group compared to placebo. Of note, 1 subject in the vibegron group was taking a weight loss medication, which is known to increase blood pressure. We have discussed these results with leading cardiology experts, and they agreed that these study results represent a very favorable outcome for vibegron. In sum, this study further confirms the overall favorable safety profile observed in the entire Phase III study, and we look forward to discussing the results with the FDA.

To build on this momentum, we are preparing the manuscript of the Phase III EMPOWUR study results for publication, and further results of the EMPOWUR study, we'll present it globally at the International Continence Society meeting in Gothenburg, Sweden in September. In the meantime, the long-term extension portion of the Phase III EMPOWUR study continues to progress well, with data expected by the end of this quarter.

We are continuing with our New Drug Application preparation for OAB indication. Earlier this year, we had a productive pre-NDA meeting with the FDA. We're on track to submit the NDA in early 2020. Of note, the team is continuing to make every effort to accelerate the filing into the fourth quarter of this year.

Regarding our supplemental development program for vibegron in men with OAB -- benign prostatic hyperplasia or BPH, we have completed enrollment in the initial Part I safety assessment in 80 patients, and an assessment or recommendation from the data safety monitoring board is expected in the fourth quarter. Part II of the trial to assess safety and efficacy in patients will start, and that is important milestone as there's currently no FDA-approved products specifically indicated for overactive bladder in men with BPH. The co-primary endpoints will be a reduction in micturition frequency and urgency episodes for 24 hours. Key secondary endpoints are reduction in nocturia episodes, which is awakening at night to void, prostate symptom scores and safety.

Our clinical program for IBS-associated abdominal pain continues to enroll patients, with the plan to enroll 200 females with IBS-associated pain due to IBS with diarrhea or mixed IBS and will be randomized to either 75-milligram vibegron or placebo. The primary endpoint is a 30% reduction abdominal pain intensity on an 11-point rating scale, which goes from 0 to 10 at Week 12 for IBS-D. The responder is defined as a subject with at least 30% decrease in worst abdominal pain compared to the weekly baseline averages. Secondary endpoints include a global rating scale on safety, in particular, in the lack of negative effect on stool frequency or consistency. We expect to report top line data in 2020.

Finally, regarding our novel injectable gene therapy for OAB, URO-902, we are pleased to announce that the Phase IIa protocol has been finalized, and we're preparing to start patient enrollment by the end of the fourth quarter in 2019.

Now I'll pass on to Christine for financial update.

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Christine G. Ocampo, Urovant Sciences Ltd. - Principal Financial & Accounting Officer [5]

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Thank you, Cornelia. In addition to the financial results summarized in the press release, you can find additional information at our upcoming Form 10-Q, which will be filed this week.

Research and development expenses were $22 million for the first quarter of 2019 compared with $28 million for the same period in the prior year. In the first quarter of 2019, research and development costs continued to be primarily attributed to our Phase III EMPOWUR trial. The decrease in R&D expenses in first quarter of 2019 compared to first quarter of 2018 is primarily attributed to a decrease in study costs due to the completion of the double-blind portion of the Phase III EMPOWUR trial.

General and administrative expenses were $5.5 million for the first quarter of 2019 compared with $3.5 million for the same period in the prior year. The increase in G&A expenses is primarily attributed to personnel costs, including share-based compensation; professional fees such as legal and accounting; and general overhead and corporate operation expenses. Total operating expenses for the first quarter of 2019 were $27.5 million compared with $31.5 million for the same period in fiscal 2018. Cash used in operations decreased by $1.5 million to $22.5 million for the quarter ended June 30, 2019 as compared to the previous quarter that ended March 31, 2019.

Our net loss for the fiscal first quarter of 2019 was $28.5 million or $0.94 per share compared with a net loss of $31.3 million or $1.56 per share for the same period in fiscal 2018. As of June 30, 2019, our total cash and cash equivalent balance was $62.4 million or $92.4 million, with the $30 million available to be drawn from Hercules Capital by September 30, 2019.

Now looking ahead to the second fiscal quarter of 2019. We currently expect our total operating expenses to be in the range of $30 million to $32 million as we close out the open-label extension portion of our Phase III trial and continue our Phase II trial for the treatment of abdominal pain due to IBS and Part 1 of the Phase III trial for the treatment of OAB in men with BPH. And for the remainder of fiscal 2019, we expect our cash used in operations to be approximately $24 million to $26 million per quarter, excluding anticipated milestone payments of $12.5 million that are due to Merck and Kyorin upon NDA filing.

And with that summary of our financial results, I'll turn the call back over to Keith for closing remarks.

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [6]

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Thanks, Christine. In summary, there are a number of milestones planned for the remainder of fiscal year 2019 that will continue to drive us towards the goal of developing Urovant into a leading specialty urology company.

To recap our recent highlights and near-term goals, first, the positive Phase III EMPOWUR results for vibegron will continue to be shared in more detail through publication and congress presentations, which will further support our belief that vibegron has the potential to be a best-in-class OAB therapy if approved by the FDA. The initial safety study of vibegron in men with OAB and BPH with an independent data safety monitoring board is on target to be completed by the fourth quarter of 2019, and we plan to move quickly into Part II of the pivotal trial for this significant unmet need. Also, with the Phase IIa protocol finalized for our novel gene therapy product for OAB, we plan to start enrollment by the end of the fourth quarter 2019, and most importantly, we continue to make great progress on our NDA with the goal of filing by early 2020.

With that, I would now like to open the line for questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Ritu Baral of Cowen.

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Ritu Subhalaksmi Baral, Cowen and Company, LLC, Research Division - MD & Senior Biotechnology Analyst [2]

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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 CNC? And then I've got a follow-up.

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [3]

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Sure. Thanks, Ritu. So as it relates to what we need for the NDA filing, we have most everything we need. Importantly, we still need the double-blind extension study results, so that was the 40-week double-blind extension of the original Phase III 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 with the NDA as quickly as possible post receipt of the stability data.

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Ritu Subhalaksmi Baral, Cowen and Company, LLC, Research Division - MD & Senior Biotechnology Analyst [4]

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

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [5]

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Yes, 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 committed safety over a full 52-week treatment period. We do have efficacy measures in the study as well. However, there's no placebo. As a reminder, the extension study is just vibegron and tolterodine, so any comparisons that we'll be looking out would just be numeric comparisons from an efficacy perspective.

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Ritu Subhalaksmi Baral, Cowen and Company, LLC, Research Division - MD & Senior Biotechnology Analyst [6]

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So is the key there to just look at durability of effect on OAB measures?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [7]

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

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Ritu Subhalaksmi Baral, Cowen and Company, LLC, Research Division - MD & Senior Biotechnology Analyst [8]

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Got it. And my follow-up is on, basically, what we're seeing out there about potentially increased awareness, 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 urologist community?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [9]

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So yes, we have done work. The work that we have done preceded all of the recent news pickups. You may have seen it on CBS News, USA TODAY with the latest journal article coming out. But what I can tell you is that prior -- the research that we did earlier this year, there's very low awareness from -- particularly patients had obviously almost no awareness. And from the clinician perspective, a small percentage of doctors had heard something, but they didn't know exactly what the data looked like. So we obviously view this as a very significant opportunity as we get closer and closer to launch to appropriately educate the doctors on this risk and also to appropriately educate patients on this risk. But to doctors and patients that we have exposed to the information and their patients, almost all of them want to switch off of an anticholinergic therapy immediately upon learning this information. And then for clinicians, they want more information. They really want to understand the risks, so they can make the appropriate trade-offs with their patients.

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Operator [10]

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Our next question comes from Joon Lee of SunTrust Robinson.

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Joon So Lee, SunTrust Robinson Humphrey, Inc., Research Division - VP [11]

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Congrats on all your progress. One of the things I was surprised to learn is that in your presentation, you mentioned about 2.4 million patients or about 7% of the patients on drug discontinued. Can you discuss some of the main reasons for discontinuation and whether the efficacy demonstrated by your vibegron in Phase III EMPOWUR study is adequate to address those deficiencies in order to be commercially successful? And I have a follow-up.

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [12]

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Great. Thanks, Joon. So the -- I think what you're referring to is we believe that about 3.3 million patients start oral therapy every year. Over 70% of them discontinue within that first year, so there's about 2.4 million patients that are back in the pool looking for a new treatment option every year, which is likely why most all products that have been launched for OAB have been quite successful with most of them achieving blockbuster status.

We think that the reason for the high dropout rate is really twofold. If you're talking about the anticholinergics, which is a majority of the prescriptions, anticholinergics, if you look at the package inserts, you can see that many of them are associated with very high rates of constipation, very high rates of dry mouth and some have even had new label updates talking about cognitive concern and ability to cause agitation.

So what we believe is that if the patients are dealing with all of those side effects, they're looking at that relative to the relief that they're getting for their OAB and they just are coming to the conclusion that it's not worth it and then therefore go back into the treatment pool, which is why we believe Myrbetriq has been so successful since being launched in 2012.

Changing gears to Myrbetriq though and looking at that information, we believe that a high percentage of patients stop using Myrbetriq early in the product -- early with the product's use because many patients, our data shows about 50% of patients are on the 25-milligram dose and due to that starting dose, patients aren't getting the full adequate relief that they could get if they dose titrated. But these patients, while it's got a great safety profile, these patients are not thrilled with the efficacy that they're getting at the starting 25-milligram dose. And therefore our research suggests that's why they're dropping off, which is why we think and having a one single convenient dose that delivers efficacious therapy at the starting dose is something that the market will accept and really adopt quite quickly.

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Joon So Lee, SunTrust Robinson Humphrey, Inc., Research Division - VP [13]

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And so just following up with that response, I believe in your subset analysis, you had included those who were previously treated with mirabegron who -- I don't know if they responded, but who responded well to vibegron. Were those patients mirabegron failures? And if so, why do you think they are responding to vibegron, given similar mechanism of action?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [14]

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Yes, all we know is that the patients in the study stopped taking mirabegron for whatever reason. We don't know if we can technically call them a failure. But obviously, for whatever reason, they started on Myrbetriq and then stopped it at some point in time. That said, obviously, we were quite pleased with the subset analysis where we saw a really robust treatment effect in those patients that had previously on mirabegron when they were given vibegron.

So we think that, again, just speaks to our enthusiasm for getting vibegron FDA approved and getting out there for patients because we think it's going to be an excellent choice for patients and hopefully, will be able to bring relief to the millions of OAB patients that are out there suffering with their OAB.

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Joon So Lee, SunTrust Robinson Humphrey, Inc., Research Division - VP [15]

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Great. And my last question is, I do appreciate your experiences at your previous -- prior firm where you successfully launched a drug in the long-term care centers. What can you tell us about your experiences there and any insights you gained that could be applied to the launch of vibegron?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [16]

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Yes, absolutely. And the long-term care setting is one that is not very straightforward. It's more of a -- essentially a facility approach to treating the patient. So there's a number of different stakeholders which have an interest in the appropriate treatment of the patients.

So we feel very fortunate that we've got a team that's got tremendous experience within this area, knows who all the stakeholders are, knows how to bring them together appropriately in order to have the dialogue and help them with patient identification and then ultimately, be able to bring -- hopefully bring relief to these patients suffering from OAB.

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Operator [17]

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Our next question comes from Eric Joseph of JP Morgan.

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Eric William Joseph, JP Morgan Chase & Co, Research Division - VP & Senior Analyst [18]

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I guess with -- first with the BP study successfully completed, maybe you could sort of just discuss practically how we should be thinking about what the implications are for a potential label in contrast to Myrbetriq. Curious to know to what extent the warnings and adverse reaction language for Myrbetriq currently give docs pause? And also whether there were any beta-3 class effects that we should be thinking about here with implications to safety language in the label?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [19]

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Yes, thanks, Eric, I appreciate the questions. So obviously, whatever we do will be a discussion with the FDA in terms of what the ultimate label looks like. Certainly, we think we've got a very strong profile with vibegron. We would expect all of the information from the ambulatory blood pressure study, from our thorough QT study, from our Phase III study, all to go within the pharmacodynamic section of the package insert in Section 12.2.

So that's certainly going to be our baseline starting discussions with the FDA. It is entirely possible that the FDA will say beta-3s have a class effect on blood pressure and therefore, we will get the same warning and precaution that mirabegron has for blood pressure within our label as well. That said, we're going to do everything that we can in our discussions with the FDA to convince them that, that is not something that should be incorporated in our label, given the extensive data that we have generated on the impact of vibegron on blood pressure.

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Eric William Joseph, JP Morgan Chase & Co, Research Division - VP & Senior Analyst [20]

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Great. And then maybe just a commercial follow-up if I could. Picking up on some of your earlier comments about script growth with Myrbetriq, its demand continues on a solid quarterly growth trend, kind of approaching something like 25% year-over-year, but recent quarter sales seems to have flattened somewhat with -- that implies some sort of net pricing pressure. I'm just curious to get a sense of what your latest market research is with respect to anticipated pricing for vibegron relative to Myrbetriq or other comps in the segment?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [21]

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Yes, yes. No, appreciate that. And we have noticed that there seems to have been a small drop off in the gross to net for mirabegron as well. We are very pleased to see that there is that robust volume growth within the -- for the only beta-3 for mirabegron, which I think speaks to the advantages of beta-3s and that people are certainly looking for relief outside of the anticholinergics.

In terms of our pricing, obviously we continue to watch mirabegron, what they do from a pricing perspective. They have taken pretty regular price increases, so we estimate that by the time we launch that their net price -- or their gross -- or their WAC price will be somewhere between $450 and $500. So we would see pricing within a band of wherever they're at of somewhere around plus or minus 20%.

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Operator [22]

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Our next question comes from the line of Raghuram Selvaraju of H.C. Wainwright.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [23]

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This is Edward on for Ram. Firstly, did you have any indication that vibegron might have applicability in some of the pain related indication beyond IBSD? And just if so, what might these indications be and how vibegron's mechanism of action maybe be applicable in some of these arenas?

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Cornelia Haag-Molkenteller, Urovant Sciences Ltd. - Chief Medical Officer of USI [24]

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Yes, so this is Cornelia. You need to have at least beta-3 receptors or organs which have beta-3 receptors responsible for the pain. That's where the idea of the IBS comes from because we have beta-3 receptors in our bladder and the gut. So that would be the only indication as of now. It is not probably to be seen as a systemic pain medication as opiates or things like that. You need beta-3 receptors for the drug to act. I mean there's potential, also there's painful bladder conditions that could be possible, which have to do with bladder contractility but that would be speculation as of now. Definitely it's a [me-too] relating to the pharmacology and the presence of beta-3 receptors.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [25]

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I see. And then moving onto BPH, I'm just wondering if physicians are indicating to you that data from COURAGE will significantly sway the prescriber decisions with respect to the usage of vibegron. And how likely might it be for vibegron usage to occur in patients with BPH who present with urgency prior to the formal extension of the label in this population?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [26]

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Yes. So honestly can't comment about how doctors may view the study and how they may incorporate it into their practice patterns. What we can say is that we are real excited about the potential for this indication. And as we've discussed before, the FDA has said specifically that they believe it is a separate and distinct indication for the treatment of OAB in men that have BPH. And so therefore, I know companies that just have an OAB indication, the FDA does not consider that appropriate for being used in these men.

If you look at the market opportunity, there's really 2 ways to win within this market. We estimate there's about 2 million men in the U.S. that suffer from concomitant OAB and BPH. Our data suggests that only about 25% of them are treated, and those that are treated are mostly treated with anticholinergics. And given anticholinergics are associated with increased risk of urinary retention, something that is very bad for this population, we think we can come in and really focus on those 25% of men that are being treated and make a very strong case to move them over to vibegron once we have this -- assuming the study is successful and we get this indication with the FDA.

But the real opportunity is in that 75% of men that go untreated. And they go untreated primarily because there has not been a huge dialogue between the doctors and the patients about their OAB. And so we believe that by bringing this data to the forefront, we can have those conversations with doctors, we will be able to have those conversations with patients and really be able to explore helping these patients and these men that are suffering from both OAB and BPH.

And when you consider that of those 2 million men, for every 100,000 that we can put on therapy represents another $300 million revenue opportunity, it's easy to see how this indication could become quite meaningful quite quickly as we will be the only FDA product approved for the treatment of men that have OAB and BPH.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [27]

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Yes, absolutely. And then finally from me, just on the gene therapy, I'm wondering if you've received any feedback from physicians regarding URO-902 and the mechanism of action? And just if so, what kind of feedback have you been receiving so far?

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Cornelia Haag-Molkenteller, Urovant Sciences Ltd. - Chief Medical Officer of USI [28]

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Well, we do have experts with whom we consulted of the protocol, that's the main feedback. And they're very much looking forward to it because again, they believe it may have, and we have to emphasize may have a longer duration of action and based on the current data, may not lead to urinary retention and that's because it's a different mechanism of action. It's not a neurotoxin. So -- and of course we need to see the study results. So the physicians we've talked to are predominantly the experts who are consulting with us on the study protocol.

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Operator [29]

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Our next question comes from the line of Biren Amin of Jefferies.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [30]

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Keith, I guess on vibegron, the pre-NDA meeting with the FDA, did the agency have any additional follow-up requests that they asked of you?

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Cornelia Haag-Molkenteller, Urovant Sciences Ltd. - Chief Medical Officer of USI [31]

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No. I mean the main meeting -- reason for pre-NDA meeting is to discuss the structure. So the file to discuss the structure of statistical tables, additional parameters. At the meeting there were no surprises, no additional requirements that the FDA brought up. They know what our package will be, and we've discussed with them and that was basically the result of the meeting. It was a productive meeting, was not a very long meeting and was productive.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [32]

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And given you're filing the NDA in early 2020 and you're likely going to have probably launch prep during the course of 2020, how are you thinking about your cash runway, given with, I guess the Hercules Capital debt facility of $30 million, if we count that, you have about 4.5 quarters of cash currently?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [33]

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Yes, so obviously from a cash perspective, we continue to be unhappy with our stock price. We don't think it's really reflective of a company that's got great Phase III data launching into a market that has created blockbuster after blockbuster. So we continue to be patient. Again we're fortunate that we've got a strong financial backer with Roivant as our parent company. And so as we move forward, we'll continue to really look at the market, look at the different ways of financing the company. But at the current time, not in a huge rush, particularly with these -- at this stock price to do something.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [34]

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Got it. And then I guess just on the additional indications for vibegron, can you talk about the IBS pain indication, where that trial is currently in terms of enrollment? So I just wanted to ask on that indication.

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [35]

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Yes, absolutely. So the study continues to enroll and as we've said, expect to have top line data in 2020. As we get closer to the end of the year and closer to end of enrollment, I think we'll be able to refine that timeline. But we still have a little ways to go with that study. But certainly expect that it's going to be a data readout in 2020 and we're going to push to make it as early in 2020 as we can.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [36]

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Okay. And then I guess just on the 902 Phase IIa trial protocol, are you dosing patients with a 24,000-microgram dose? And then I think previously, you've mentioned that you would dose on a single administration to assess for durability. And just wanted to get your thoughts on how long you'll follow these patients in the IIa trial and whether these patients coming into the study will have failed on Botox and/or neuromodulation.

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Cornelia Haag-Molkenteller, Urovant Sciences Ltd. - Chief Medical Officer of USI [37]

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Okay. To answer your first question after consulting with the experts, they advised against taking Botox failures into the Phase IIa study because there's no reason to know why there's Botox failures. So definitely we will have patients who are non-Botox failures for the bladder. And then the first, as you note the 20 -- as you noted, the 24,000-microgram was the highest dose in the Phase Ib that was effective. We're going to start with this, then we're going to have a data monitoring safety board review, then we're going to dose 1 higher dose and then we're going to follow in total 48 weeks.

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Operator [38]

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Thank you. At this time, I'd like to turn the call back over to Keith Katkin for any closing remarks. Sir?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [39]

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Thank you very much. Appreciate everybody's time this afternoon and look forward to keeping everyone apprised of our progress through the remainder of the year. Have a great afternoon and great evening.

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Operator [40]

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Ladies and gentlemen, this concludes today's conference. Thank you for your participation. You may disconnect your lines at this time. Have a great day.