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Edited Transcript of UROV.OQ earnings conference call or presentation 5-Nov-19 9:30pm GMT

Q2 2020 Urovant Sciences Ltd Earnings Call

Nov 9, 2019 (Thomson StreetEvents) -- Edited Transcript of Urovant Sciences Ltd earnings conference call or presentation Tuesday, November 5, 2019 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Ajay Bansal

Urovant Sciences Ltd. - CFO & Senior VP of Business Development

* Christine G. Ocampo

Urovant Sciences Ltd. - CAO & Senior VP

* Cornelia Haag-Molkenteller

Urovant Sciences Ltd. - Chief Medical Officer of USI

* Keith A. Katkin

Urovant Sciences Ltd. - CEO & Director

* Ryan Kubota

Urovant Sciences Ltd. - Executive Director of IR

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Conference Call Participants

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* Edward D. Marks

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

* Joon So Lee

SunTrust Robinson Humphrey, Inc., Research Division - VP

* Turner Andrew Kufe

JP Morgan Chase & Co, Research Division - Research Analyst

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Presentation

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Operator [1]

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Ladies and gentlemen, thank you for standing by, and welcome to the Urovant Sciences Fiscal 2019 Second Quarter Financial Results Conference Call. (Operator Instructions) As a reminder, today's conference is being recorded. I'd like to turn the conference over to Ryan Kubota, Executive Director of Investor Relations. Please go ahead, Mr. Kubota.

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Ryan Kubota, Urovant Sciences Ltd. - Executive Director of IR [2]

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Thank you, operator. Good afternoon, and thank you all for joining Urovant's Fiscal 2019 Second Quarter Financial Results Conference Call. With me today are 4 members of our leadership team: Keith Katkin, Chief Executive Officer; Christine Combo, Chief Accounting Officer; Dr. Cornelia Haag-Molkenteller, Chief Medical Officer; and Ajay Bansal, our new Chief Financial Officer and Senior Vice President of Business Development.

Today, after market close, we issued a press release containing detailed information on our quarterly results. You may access the release on our company website, urovant.com.

During our call, we will be making forward-looking statements, including statements regarding our planned 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 as we file it later this week.

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

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

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Thank you, Ryan, and my thanks to all of you for joining us today. First, I would like to welcome Ryan Kubota, our new Head of Investor Relations. Ryan joins us from Molina Healthcare, and we look forward to speaking with all of you in the upcoming weeks.

This has been an exciting quarter for Urovant. We achieved key clinical milestones for our OAB development program for vibegron, and now with the substantial financial commitment and enhanced commercial support from the Sumitomo Dainippon Pharma, we are in an optimal position for developing Urovant into a leading specialty urology company.

Last week, Roivant Pharma and Sumitomo entered into a definitive agreement for the creation of a broad Sumitomo-Roivant strategic alliance, which, upon close, will result in Sumitomo becoming the new majority shareholder of Urovant Sciences. In conjunction with the definitive agreement with Roivant, Urovant also entered into an agreement with Sumitomo, whereby Sumitomo has committed to provide Urovant with the following things: first, a $200 million low interest, interest-only 5-year term loan facility; second, certain minority shareholder protections; third, access to enhanced commercial support from the Sumitomo U.S. franchise Sunovion; and finally, expected financial support through profitability.

As you know, DSP is a well-known top 10 Japanese-listed multinational pharmaceutical company with an extensive history of innovation in drug development and commercialization. The company generated over $4 billion in revenue last year through the commercialization of several large pharmaceutical drugs in the United States, including the blockbuster drug Latuda. We look forward to this promising new alliance with Sumitomo as we prepare for the commercial launch of vibegron. Our new drug application or NDA filing and launch preparations for vibegron are well underway, and we're excited to have the strategic support and proven commercial resources of Sumitomo. This partnership should greatly optimize Urovant Sciences' commercial approach to the U.S. market with enhanced resources for drug distribution, operations and managed care support.

Now regarding this quarter results, we achieved another pivotal milestone with the completion of the long-term extension of the Phase III EMPOWUR study of vibegron for patients with overactive bladder. The study achieved its primary objective, confirming vibegron's safety -- favorable safety and tolerability profile and demonstrating further improved treatment benefit on the key overactive bladder symptoms over the 40-week extension period.

In addition, we completed our pharmacokinetic study of vibegron as a crush tablet. These results are expected to support labeling for the administration of vibegron as a crushed tablet in soft food, a potentially significant advantage for elderly OAB patients who have trouble swallowing. With these key studies complete, final preparations for our NDA for vibegron for patients with OAB are progressing quickly for filing in early 2020, if not, sooner.

Other important business highlights include: initiation of Part II of the Phase III COURAGE trial, which will assess both efficacy and safety of vibegron in men with OAB and BPH, a patient population for which no product is currently approved; continued enrollment of female patients into IBS-associated abdominal pain trial with top line results expected in 2020; and finalization of the Phase IIa protocol for OAB for URO-902, our novel injectable gene therapy product, which is planned to commence patient enrollment by the end of the fourth quarter of 2019.

With that, I'll turn the call over to our Chief Medical Officer, Dr. Cornelia Haag-Molkenteller, who will 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 have achieved key milestones for our OAB program from vibegron and continue to make excellent progress across our other clinical development programs. We are pleased to report positive long-term data from the 40-week extension of the Phase III EMPOWUR study of vibegron in patients with overactive bladder. This was a double-blind 40-week extension of the 12-week placebo-controlled EMPOWUR Phase III study, 505 patients from the EMPOWUR study received blinded study medication of either vibegron 75-milligram or tolterodine 4-milligram extended release.

Those already on vibegron or tolterodine from the EMPOWUR study remained on their respective treatment for a total of 52 weeks of exposure. And the placebo patients from the EMPOWUR study were randomized to either vibegron or tolterodine for a 40-week treatment period. Of the 505 patients in the long-term extension, 85% finished the trial, a very high completion rate for a 40-week study.

The primary objective of the long-term study was safety and tolerability, and the secondary objective was sustained efficacy of vibegron, a reduction in micturitions, urge urinary incontinence and urgency episodes. We are pleased to report that in addition to demonstrating favorable safety and tolerability profile, the study showed further improved treatment benefit on key overactive bladder symptoms and the improvement from 12-week onwards was sustained over the entire 40-week extension study.

Among the 52-week EMPOWUR vibegron treatment group, the reduction micturitions at week 52 was minus 2.5 episodes per day from a baseline of 11.3 episodes, and a reduction in urgency episodes was minus 3.4 episodes per day from a baseline of 8 episodes. In addition, vibegron demonstrated sustained efficacy for urge urinary incontinence, the most bothersome and embarrassing symptom of OAB. The reduction in urge incontinence was minus 2.2 episodes at week 52 from a baseline of 3.2 per day. Overall, a total of 61% of vibegron patients achieved a 75% reduction of their baseline urge incontinence episodes after 52 weeks of treatment, and 41% of vibegron patients were totally dry, meaning without incontinence episodes after 52 weeks.

We are also particularly pleased to see that vibegron achieved numerically better efficacies on tolterodine, the active control at every time point measured. The adverse event profile of vibegron from the extension study was consistent with the 12-week EMPOWUR Phase III study. Adverse event rates were below 10%, and the adverse event rate for hypertension was in the range as for tolterodine, the active control. These data reinforce our belief that vibegron has the potential to become the best-in-class oral OAB treatment. Plans for publication and presentation of both the EMPOWUR Phase III study and the long-term extension results are well underway.

Recently, a detailed view of the EMPOWUR results was presented globally at the International Continence Society Meeting in Gothenburg, Sweden in September 2019. Presentations of the long-term data are planned for future scientific meetings in 2020.

In addition to the completion of the long-term extension of the EMPOWUR Phase III study this quarter, we also completed the Phase I study on food effect with the final vibegron 75-milligram tablet and testing of pharmacokinetic parameters if the tablet is crushed and administered in applesauce. The study results will be used to support the proposed labeling for administration of vibegron without or with food and as a crushed tablet in soft food, which is an important potential benefit as many elderly patients have difficulty swallowing.

Regarding our supplemental development program for vibegron in men with OAB and benign prostatic hyperplasia or BPH, the Phase III COURAGE program, the independent Data Safety Monitoring Board reviewed the safety data from the 82 patients enrolled in Part I of this trial and agreed that the study can now move to Part II of the trial, which -- in which over 1,000 patients will be enrolled. Part II of the Phase III trial will assess both efficacy and safety of vibegron in the OAB and BPH population, a pivotal milestone as there currently is no FDA-approved product specifically indicated for overactive bladder in men with BPH.

The co-primary end points are the reduction micturition frequency and urgency episodes for 24 hours. Key secondary end points are reduction in nocturia episodes, awakening at night to void, prostate symptom scores and safety. In addition to the initiation of the Part II of the Phase III COURAGE study, patients from Part I have enrolled into the long-term extension study, which will follow patients for a total exposure of 52 weeks.

Regarding our clinical program for IBS-associated abdominal pain, study continues to enroll female patients with IBS-associated pain who were then randomized to either 75-milligram of vibegron or placebo. The primary end point is a 30% reduction in abdominal pain intensity on an 11-point rating scale at week 12 for IBS-D, which is IBS with diarrhea. A responder is defined as a subject with at least 30% decrease in the worst abdominal pain compared to the week-2 baseline averages. Secondary end points include global rating scale and safety, in particular, the lack of negative effects of stool frequency or consistency. We expect to report top line data from this study in 2020.

Finally, regarding our novel injectable gene therapy for OAB, URO-902 Phase IIa protocol preparations are proceeding per plan for the start of the study in the U.S., and we expect to start patient roll-on by the end of fourth quarter 2019.

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

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Christine G. Ocampo, Urovant Sciences Ltd. - CAO & Senior VP [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 later this week.

Research and development expenses were $17.8 million for the second quarter of 2019 compared with $20.7 million for the same period in the prior year. In the second quarter of 2019, research and development expenses were comprised of cost related to clinical development, specifically the open-label phase of our Phase III OAB trial as well as our ongoing studies in OAB, BPH and abdominal pain associated with IBS. When comparing the 2 quarters, the decrease in R&D expenses is primarily due to a decrease in cost associated with the Phase III OAB trial, as both the double-blind and open-label phases of this trial were completed in 2019.

General and administrative expenses were $7.4 million for the second quarter of 2019 compared with $3.6 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, commercial readiness cost and general operating expenses.

Total operating expenses were $25.2 million for the second quarter of 2019 compared with $24.3 million for the same period in the prior year. Cash used in operations was $24.5 million for the quarter ended September 30, 2019, an increase of $2 million as compared to the immediate prior quarter ended June 30, 2019.

Net loss was $25.7 million or $0.85 per share for the second quarter of 2019 compared with a net loss of $24.6 million or $1.23 per share for the same period in the prior year. At September 30, 2019, the balance of total cash and cash equivalents was $67.8 million.

Now looking ahead to the remainder of fiscal 2019. We expect our cash used in operations to be approximately $26 million to $28 million per quarter, excluding milestone payments of $12.5 million, which will become due on filing of our NDA. For the third quarter of 2019, we expect our total operating expenses, excluding milestone payments, to be in the range of $30 million to $32 million, as we plan to recognize expense for prepaid expenses that are associated with the Phase III OAB trial. With the additional $200 million loan facility from Sumitomo, we expect to be funded well into 2021. In addition, we expect Sumitomo will continue to fund Urovant Sciences' operating needs through profitability, which will provide financial stability as we move forward with the vibegron launch and our additional development program.

And finally, now that we have passed the 1-year anniversary of our initial public offering, we believe it is prudent financial planning to have an active shelf and an at-the-market facility, or ATM, in place. As such, in the near term, we expect to file a $200 million form S-3 registration statement, which will include a $50 million ATM.

And with that financial update, I will turn the call back over to Keith.

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

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Thanks, Christine. Before I move to my closing remarks, I would like to introduce you to Ajay Bansal, our new Chief Financial Officer and Senior Vice President of Business Development. Ajay brings over 16 years of finance, business development, accounting and mergers and acquisitions experience in start-up and larger biotech environments as a Chief Financial Officer. He has led the growth and strategic capabilities for several leading and innovative biotechnology companies. Ajay also brings a very unique set of experiences to Urovant, which I believe will enhance and strengthen our strategic business development and financing capabilities.

Ajay, would you like to say a few words?

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Ajay Bansal, Urovant Sciences Ltd. - CFO & Senior VP of Business Development [7]

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Thank you, Keith. Firstly, I'm just delighted to be here at Urovant. I believe it's a terrific time for me to be joining Urovant with the vibegron NDA filing coming up soon followed by launch preparations and now with enhanced financial resources at our disposal, the next 2, 3 years are going to be very exciting and critical in the evolution of Urovant into a leading specialty urology company. I'm impressed at vibegron's clinical data to date, and I believe that it has the potential to become a best-in-class therapy for OAB patients. I'm delighted to be a part of this journey and look forward to interacting and meeting with several of you over the coming weeks.

With that, let me turn the call back to Keith for closing remarks.

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [8]

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Thanks, Ajay. I would like to reiterate our excitement for the new alliance with Sumitomo, which should provide long-term financial stability for Urovant while also providing access to a global -- to global platform of enhanced commercialization resources and other significant advantages as we prepare for the launch of vibegron.

In closing, the second fiscal quarter of 2019 marked key milestones across all aspects of our business, and we look forward to several upcoming milestones that will continue to drive us toward the goal of developing Urovant into a leading specialty urology company. These upcoming milestones include filing our NDA for vibegron in overactive bladder by the first quarter of 2020 with the possibility of accelerating the file into late fourth quarter 2019; initiation of Part 2 of the Phase III COURAGE trial, which will assess both the efficacy and safety of vibegron in men with OAB and BPH; continued enrollment in our Phase II IBS-associated abdominal pain study with top line data readout expected in 2020; and the start of patient enrollment into the Phase IIa of our novel injectable gene therapy for OAB, URO-902, by the end of the fourth quarter of 2019.

With that, I'd now like to open up the call 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 is from Ritu Baral from Cowen.

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Unidentified Analyst, [2]

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This is [Dushant] on for Ritu Baral. Two questions from our end. The first is any expectations for a differentiation in terms of the labeling for vibegron versus Myrbetriq, so just like a better safety language. And the second question is given that the patent is set to expire on Myrbetriq in 2023, how do you see that affecting uptake in the next 5 years and if generics [would possibly] hit the market and possibly insurance coverage?

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

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Sure. Appreciate that. And let me try and tick those off one at a time. I think, first, as it relates to differentiation, we actually think that our package insert will likely be differentiated from mirabegron in a number of different ways. First, let me touch on the efficacy parameters. I think, first and potentially most importantly, we believe that the charts in our label will demonstrate a 2-week onset of action as our Phase III study demonstrated vibegron's efficacy at 2 weeks. And this compares very favorably to mirabegron's starting dose of 25 milligrams, which the package insert clearly states that it takes up to 8 weeks to work. So in our market research, that has resonated very strongly with both doctors and patients.

Additionally, I think as we've discussed before, based on our discussions with the FDA, we believe that we may be able to have some additional efficacy end point that no other OAB drug has had in their package insert. This would include the outcome of urgency given our strong performance in the Phase III on the urgency end point and also responder analyses, many of the things that Cornelia was talking about, for example, the percent of patients that experienced a 75% reduction in their urge urinary incontinence episodes, things of that nature. So we think, we'll be well differentiated from an efficacy perspective.

From a safety perspective, there, too, we think there'll be a number of points of differentiation. First and foremost, our lack of drug-drug interactions, particularly on 2D6. If you look at the mirabegron label, they certainly do inhibit 2D6, and from our market research, almost 40% of patients that are taking mirabegron are on drugs that are metabolized via that pathway and therefore, giving those patients a new option where they don't have to worry about drug-drug interactions, we believe, will be very meaningful for them as well. In addition, we have demonstrated that vibegron has no impact on QTc, whereas mirabegron, we know at supratherapeutic dose, it does have that impact on QTc.

And then finally, just to wrap up, our single convenient dose will certainly be an advantage versus vibegron's dose titration and our ability to be crushed, particularly for the elderly patients who have problems swallowing, whereas mirabegron can't be crushed because it's an extended-release formulation. So we think there's a whole host of reasons why physicians and patients will prefer vibegron over mirabegron, and we very much look forward to getting that NDA in and getting FDA approval.

As it relates to your question about the generic entry for mirabegron, right now, we're uncertain whether that will happen at the end of 2023 or sometime in 2024. But irrespective, it'll give us about 3 years of marketing with them before the generic is introduced. And we think that's plenty of time to establish vibegron as a best-in-class OAB product. Additionally, as we've had discussions with payers evenly -- even as recently as last week, the payers do not view this as a highly managed category. They have communicated to us they would not expect to have a step-through of mirabegron to use vibegron whatsoever. It's just not cost effective for them to have to do that within their plans. So all in all, we are extremely excited at the profile that's emerged from vibegron in the studies and how we'll be able to effectively position ourselves versus mirabegron.

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Operator [4]

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Our next question is from Eric Joseph from JPMorgan.

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Turner Andrew Kufe, JP Morgan Chase & Co, Research Division - Research Analyst [5]

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This is Turner on for Eric. I'm just hoping you could elaborate a bit on the commercial support you'll receive from Sumitomo and if there are any specific aspects of distribution and/or sales force that you are able to leverage. And does this change your plan to 150-person sales force and initial efforts to target primarily urologists in long-term care centers? And then one other quick one. I'm just -- it's been a while since we've heard anything. I'm just curious if there's an update for the IBS pain study.

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

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Sure. Appreciate the questions, Turner. So we are still exploring and having discussions with Sumitomo's U.S. business here, which is Sunovion. They have quite a large infrastructure and obviously have demonstrated a tremendous amount of success with the sales of Latuda exceeding $2 billion. We talked to them so far about a host of different areas where we may be able to collaborate with them. Certainly, drug distribution is an important focal point for us. You're probably well aware that smaller companies, wholesalers [whole hosted] -- with very high wholesaler service fees. We think now that we can -- that we'll be under the Sumitomo umbrella, we can have access to their much lower wholesaler service fees, which should actually save us a fair bit on gross margin.

Additionally, they've got a very large managed care footprint with a number of account managers and account executives. So we're discussing with them how we can potentially tap into all of those relationships and also having the leverage of the full Sunovion franchise in the U.S., and we're having discussions with payers. And then they also have a number of back-office commercial support capabilities as well, which we're exploring with them. And so all in all, I think to the extent that people had concerns about our ability to launch as a small company, I think the ability to tap into the Sunovion and Sumitomo infrastructure should greatly alleviate any concerns that people have about a "small company" being able to effectively commercialize as well.

In regards to your question about sales force and sales force expectations, we continue to expect that we'll have a 100-person urology field sales force. We've already brought on a national sales director for that team, who's got tremendous experience in urology, and we look forward to being able to ramp up that field sales team as we get near approval. Additionally, we'll have a 50-person long-term care sales force, which we will be able to focus and call upon all of the key accounts and key homes within that area.

We are having some discussions with Sunovion about -- is there a potential for a copromote. I think it's too early on whether or not that's something that we could reasonably expect on anything that we would do with them. We would treat it at an arm's length transaction and would have to make sense for Urovant and Urovant shareholders for us to potentially do -- to do something like that.

And then I think your second question was in regards to the IBS pain program. That program continues to move forward with top line data expected in 2020. And so we're very much looking forward to providing continued updates on that program as we continue enrollment there.

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Operator [7]

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We have now the line of Raghuram Selvaraju from H.C. Wainwright.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [8]

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This is Edward Marks on for Ram. I appreciate you taking the questions. Just to go back to the Sumitomo arrangement really on the earlier half after you've just gone through the commercialization. Just wondering if you could lay out more of the spending plan for that initial $200 million. And then specifically, just a few points, just wondering about that $100 million Hercules Capital loan, whether you'll pay that down with the $200 million, whether more funds will be devoted towards the launch or some of the clinical aspects that are still ongoing and then wondering also if there's a roof on how much capital Sumitomo was willing to commit before you guys reach profitability.

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

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Appreciate all of the questions. So I think, in general, our spending plan is unchanged, and as Christine had said, with the $200 million loan facility, we expect that we'll be funded well into 2021. We are, as you'd expect, certainly, evaluating whether or not we should pay down the Hercules loan. What we expect, that the Sumitomo loan will be at a lower interest level, and so it may make really good, prudent sense to retire that. But we'll need to go through that with our Board and look at all the economics associated with that deal.

In terms of more dollars on clinical programs or commercial. We have always had a pretty full plant -- full plan as it related to commercial spending and clinical spending. So I don't really foresee any increase in spending on that front but rather, as Christine had said, with the guidance for the remainder of this year, staying on track with that guidance.

And then finally, in terms of a cap on relative spends, that -- obviously, we're still very early in the relationship with Sumitomo. So we are very appreciative that they expect to fund the company through profitability. And we'll have to discuss with them, as we move forward and execute on our plan, on exactly what that full capital commitment would look like. We obviously do want to continue with our business development efforts. We want to bring in more products and continue to grow the pipeline of Urovant, so that will be a big focus for us as well as we kick off our relationship with Sumitomo.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [10]

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Excellent. I appreciate all the details. Just a little bit on Sumitomo's strategy. What's their commitment and interest level for indications beyond OAB for vibegron? And then I have one more follow-up.

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [11]

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Yes, certainly. So I think if you put yourself in their shoes, they're looking at a $2 billion patent cliff in 2023 when Latuda goes generic. And so I think they're taking a very intelligent approach with a number of different shots on goal, so to say, with products that can fill that pipeline gap, and I think vibegron is one of the more important products that they have that could potentially fill that pipeline gap for them. So I believe that they're open to maximizing the full potential of vibegron in all possible indications. Obviously, we're all very excited about OAB. We're very excited to potentially be the first product ever approved for men that have OAB and BPH. And certainly, to the extent we saw a robust treatment effect in IBS pain, I think there would certainly be capital available to support that very large indication with a number of patients out there suffering from IBS-related abdominal pain.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [12]

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That makes a lot of sense. And then final question, just on the long-term 52-week data. It does compare very favorably to the long-term data from mirabegron. I'm just wondering when that full data will be released and whether it's going to be in a presentation or publication form. And then when you're talking to prescribers about this long-term data, what is the degree to which they're indicating they find this long-term superiority to tolterodine more clinically meaningful?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [13]

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Cornelia, do you want to comment in terms of the publication plan and timing?

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Cornelia Haag-Molkenteller, Urovant Sciences Ltd. - Chief Medical Officer of USI [14]

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Yes, okay. Well, this is Cornelia. So we plan to present the long-term data first at the Scientific Congress most likely in the early second quarter of 2020, and that will be followed by full paper publications. So it will first be presentations. You can expect it to be in the second quarter of 2020 and then publications. That will be the first one. Keith, do you want to take the prescriber question?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [15]

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Yes, certainly. And so certainly, as you'd expect, the health care providers that we've shared the long-term data with are very excited at that data. And I think, as you astutely pointed out, the numeric benefit of vibegron versus tolterodine is not lost on many of them, especially when you consider the fact that with mirabegron in their one study, which included tolterodine, mirabegron actually performed worse than tolterodine on a number of those end points throughout the 52-week period. So we think it really supports the best-in-class and potentially best-in-area efficacy profile of vibegron, and as I said, look forward to moving vibegron through the approval process with the FDA.

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Operator [16]

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Next, we have Joon Lee from SunTrust.

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Joon So Lee, SunTrust Robinson Humphrey, Inc., Research Division - VP [17]

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Congrats on becoming part of the Sumitomo family. As you mentioned, the starting dose for mirabegron is 25 milligrams. What's the typical steady-state dose for mirabegron? Is that eventually end up being 50 or 75 milligrams? And how does the efficacy at a higher dose compare with 75 milligrams of vibegron? And I have a follow-up.

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [18]

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Yes. So if you take a look at IQVIA data in terms of what the mix of the mirabegron business is, it's about 40% to 45% of the 25-milligram and the remainder being 50 milligrams. So almost half of the market there is on the lower dose and doesn't wind up progressing to the higher dose or is potentially just falling off of therapy because they're starting on that smaller dose and not getting the relief that they want.

And so to the second part of your question about comparing the mirabegron 50-milligram data with vibegron 75-milligram data there. If you look at previous studies between mirabegron and do a cross-study comparison to vibegron, which certainly has certain limitations, you will see that the relief provided by vibegron on a numerical -- on a numeric base is actually higher than what we're seeing with vibegron -- that we're seeing with mirabegron. And so I think that relates to the last question that was asked, looking at tolterodine, there's an active control and why we're so pleased that we were able to be numerically better than tolterodine at all time points in the 52-week extension study.

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Joon So Lee, SunTrust Robinson Humphrey, Inc., Research Division - VP [19]

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So the patients who don't get relief from 25 or maybe 50 milligrams of mirabegron, do physicians typically explore higher dose as tolerated? Or -- and how many patients actually tolerate the higher dose if that is something that physicians try to do?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [20]

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Yes. I think what our research suggests is that you would think that the communication between the patient and the physician is better than it is, but it's really not. So the patient gets the 25-milligram dose. They maybe get it as a sample or prescription. They fill it. They wind up not getting the relief that they were hoping for either because the doctor didn't fully prepare them on what to expect or because they had higher hopes themselves. And then many of these patients wind up stopping mirabegron very early in the treatment cycle. And a large percentage come off within 3 months. And so we think that's a huge opportunity, one, to pick up those mirabegron failures in all those patients that are coming off within -- around a 3-month period. But also why start with a subtherapeutic dose with another product that inhibits 2D6, has GT concerns and doesn't work fast when you could have a product that works fast, doesn't have any DDI concerns and doesn't have any GT concerns. And so we think that the prescribing decision is going to be pretty easy once we're -- once vibegron is out there and available for the physician.

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Joon So Lee, SunTrust Robinson Humphrey, Inc., Research Division - VP [21]

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Great. And then I totally understand that it's just house -- a good housekeeping to have a shelf in place. But what would be the use for that $20 million in the shelf and $50 million in ATM given that you have a low-interest $20 million loan from Sumitomo?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [22]

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Yes. At the current time, we just think and our Audit Committee believes that it's just good, prudent financial planning. You never know what may happen, and you may want to opportunistically take advantage of funds that are available out there. And so the last thing we would want to do is not be in a position where we could take advantage of capital market that they were strong, and our Board thought that they were worth tapping into. But at the current time, obviously, we're very happy with the $200 million that we've received from Sumitomo, and we'll just continue to monitor market conditions, stock price, things of that nature as we move forward.

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Operator [23]

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(Operator Instructions) We have again the line of Raghuram Selvaraju from H.C. Wainwright.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [24]

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Edward Marks here. Just 2 quick ones for me. Just making sure the stability testing data is still the major gating factor for that NDA submission and that is still on track to be completed in December.

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [25]

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That is correct. And it's kind of like watching paint dry now as we're waiting to get to that data next month.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [26]

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I can imagine. Yes. And then just finally on a broader level in terms of the OAB market growth, it seems to be growing pretty strong and considering some of the details that you talked about with Astellas' patent cliff, they seem to be backing out of active promotion of Myrbetriq. So I'm wondering if you could talk about what's really driving this consistent OAB market growth. And what -- I'm sorry, if patients are actually switching to beta-3 medications, would the messaging for vibegron focus more on this differentiation versus mirabegron? Or would there still be a need to have a broader conversation around the benefits of beta-3 medications over stuff like the anticholinergics?

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [27]

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Yes, it's a really good question. And I think what's important to note is that, as you look at the market, still a large majority of the market are anticholinergics. And as we've talked about in the past, there's more and more emerging literature about the concerns of anticholinergics, their impact on cognition and certainly the increased risk of dementia from the use of those anticholinergics. So as we sit back and as we think about where the biggest market opportunity is, the biggest market opportunity is not going head to head with Astellas and trying to fight for those patients that are going over to a beta-3. We think when they make that choice, obviously, we want to position vibegron as the best choice, but we really think that the big opportunity is conversion of those patients from anticholinergics over to a beta-3.

And so if you look at historical class situations where you've got an existing class like the anticholinergics and then a new class like the beta-3s, typically, when you see a second in class products come out, you see, I think, a large expansion in that class of product. So our hope is that the beta-3 class expands when we're on the market as well, and, that we are converting more patients from anticholinergics over to beta-3s than we are taking patients from mirabegron. And we think, quite frankly, that just represents a win-win for both us and Astellas and for patients because beta-3s are better and safer, in our opinion, than the anticholinergics for these patients suffering from OAB.

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Operator [28]

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(Operator Instructions) We don't have any further questions at the moment. That brings us to the end of the question-and-answer session of today's call. I will turn the call over to Keith Katkin for the closing remarks.

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Keith A. Katkin, Urovant Sciences Ltd. - CEO & Director [29]

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Thank you very much, operator, and we appreciate everybody joining us for our call today and look forward to providing you with continued updates on our progress. Have a great day.

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Operator [30]

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Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.