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Edited Transcript of UROV.OQ earnings conference call or presentation 18-Jun-20 8:30pm GMT

Q4 2019 Urovant Sciences Ltd Earnings Call

Jun 18, 2020 (Thomson StreetEvents) -- Edited Transcript of Urovant Sciences Ltd earnings conference call or presentation Thursday, June 18, 2020 at 8:30:00pm 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

* Cornelia Haag-Molkenteller

Urovant Sciences Ltd. - Chief Medical Officer of USI

* James A. Robinson

Urovant Sciences Ltd. - Principal Executive Officer & Director

* Ryan Kubota

Urovant Sciences Ltd. - Executive Director of IR

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Conference Call Participants

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* Eric William Joseph

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

* Raghuram Selvaraju

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Suranjit Mukherjee

Jefferies LLC, Research Division - Equity Associate

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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 Fourth Quarter 2019 Earnings Conference. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

I will now hand the conference over to your speaker today, Ryan 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 Fourth Quarter Financial Results Conference Call. With me today are key members of our leadership team, Jim Robinson, President and Chief Executive Officer; Ajay Bansal, Chief Financial Officer; and Cornelia Haag-Molkenteller, Chief Medical Officer. Christine Ocampo, our Chief Accounting Officer, is also present and will join us for the Q&A portion of the call.

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. We use our website as a channel to distribute important and time-critical company information, and you should look to the Investor Relations page of our website for this information.

During our call, we will be making forward-looking statements, including statements regarding our plans and strategies of 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, which will be filed tomorrow.

With that said, I will now turn the call over to our President and CEO, Jim Robinson. Jim?

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James A. Robinson, Urovant Sciences Ltd. - Principal Executive Officer & Director [3]

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Thank you, Ryan, and thanks to all of you for joining the call today. It's great to meet you virtually, and I hope I'm able to connect personally with more of you very soon.

As many of you know, before joining Urovant as President and CEO in March, I was on the Board of the company for over a year. And as I've gotten to know the organization and the leadership team, I've been impressed by what's been accomplished and increasingly confident about the opportunity we have ahead of us, particularly for vibegron. I've had significant experience in the urology space, and in particular, know the needs of the overactive bladder patient population well. And as we've examined the data from our trials, what we've learned about vibegron leads me to believe that we could be looking at the potential approval of a differentiated, perhaps highly differentiated medicine. A medicine that, if approved, has significant potential in a market where patient dissatisfaction and the need for new treatments is high, where there hasn't been a new branded oral therapy launched since 2012 and where the condition drives significant health care utilization and costs. Vibegron has been specifically developed to address many of the limitations of current therapies, and the extensive clinical development program that's been completed enhances my belief that it could be a welcome new treatment.

Overall, 3 large trials have been conducted for vibegron in over 4,000 patients with overactive bladder. These include both the EMPOWUR trial, which was our 12-week pivotal efficacy and safety study and the EMPOWUR 40-week extension trial. In these trials, not only did once-daily 75 milligram vibegron meet all primary and key secondary efficacy endpoints, it also showed a highly statistically significant improvement in all primary and secondary endpoints versus placebo. Vibegron did that while maintaining durable efficacy out to 52 weeks and demonstrating a favorable safety and tolerability profile. Equally important in the trials, vibegron demonstrated a rapid onset of action, showing meaningful reduction in symptoms as early as 2 weeks. Cornelia will talk about this in greater detail in a moment, and I'll also touch on our other development efforts, including progress in the trial of our novel gene therapy, URO-902, which is being studied for treatment of patients suffering from overactive bladder with urge urinary incontinence or UUI.

But before I turn over to Cornelia, let me take a few minutes to talk more about our immediate priority, and that's preparing for the potential approval and successful launch of vibegron. As I mentioned earlier, unmet patient need in OAB is high. More than 30 million Americans suffer from overactive bladder and 14 million discuss their symptoms with their doctor. There are roughly 3.5 million patients on prescription therapy each year, of which a full 50% are new to therapy. And 1/3 of these patients don't stay on treatment. And that's, in some cases, because of the time it takes for current therapies to become effective. Today, nearly 18.5 million prescriptions are written in the U.S. each year for the treatment of overactive bladder. And of those 18.5 million plus prescriptions, roughly 80% for anticholinergics, the balance of prescriptions are for the only beta-3 agonist currently in the market, and this beta 3 market continues to grow. In addition, we know that better addressing the needs of patients with OAB has the potential to lower the overall cost of care. Unfortunately, overactive bladder is often dismissed as a quality of life issue, but it has very real impacts, especially for patients and our health care system. Consider these published facts. Annual direct medical costs for OAB patients are more than 2.5x higher than for non-OAB patients. Admission to a nursing facility is 2x greater for incontinent women and 3x greater for incontinent men. And when OAB is treated, there's a 23% decrease in non-pharmacy cost versus those patients who remain untreated.

With its efficacy and safety profile, we believe vibegron has the potential to reduce the burden of OAB by improving lives of patients and lowering health care cost. As you know, the target PDUFA date for vibegron is December 26 of this year, and we're rapidly moving forward with building our commercial infrastructure for launch. A key element of building this infrastructure has been the recent hiring of Walt Johnston, our Senior Vice President of Commercial; and Ken Stewart, Senior Vice President of Market Access. And just this morning, we also announced a 3-year agreement with Sunovion, an affiliate of our majority shareholder, Sumitomo Dainippon Pharma to provide us with trade, distribution and select operational services. As our plans progress, we'll provide additional details.

Now with that, let me turn the call over to our Chief Medical Officer, Dr. Cornelia Haag-Molkenteller, who will provide more details on 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, Jim. As Jim just stated, we submitted our new drug application for vibegron for the treatment of OAB to the FDA in December 2019. And on March 5 this year, the FDA notified us that they have accepted our NDA for review that our PDUFA goal date has been designed for December 26, 2020. We continue to expect a 12-month review cycle at the FDA and are currently responding to FDA requests as part of the regular review cycle.

Let me now provide updates on further data presentations for vibegron and OAB and our other clinical development programs. In March, the manuscript for the 12-week EMPOWUR Phase III study was published online in the Journal of Urology. The key peer review journal, Dr. David Staskin, the principal EMPOWUR study investigator and a leading urologist from Boston is the first author, and we expect the print publication to be available in August.

This year's annual American Neurological Association meeting was conducted virtually due to the COVID-19 pandemic. The 2 EMPOWUR presentations were accepted for the meeting and are posted on the AUA website on May 15. The first presentation was of our 52-week EMPOWUR extension study data and post hoc analysis. The second presentation included EMPOWUR data by age. Let me provide a little more detail on both of these presentations. The EMPOWUR extension study demonstrated that vibegron was able to sustain its efficacy over the 52 weeks of observation with a very favorable long-term efficacy results and a good long-term safety and tolerability profile. In addition, we performed a post hoc analysis to test the difference at week 52 between vibegron 75 milligram and the active comparator tolterodine on the change from baseline and urge urinary incontinence or UUI and total incontinence. In both of these measures, vibegron demonstrated a statistically significant reduction over tolterodine. The symptoms of urinary incontinence are key symptoms in OAB and the main reason for patients to seek treatment. This post hoc analysis further supports the strong efficacy profile of vibegron. The placebo-controlled 12-week EMPOWUR Phase III data by age examined patient data below and above the age of 65. For patients aged 65 years and older, statistically significant improvements were seen with 75 milligram vibegron compared to placebo in the co-primary endpoints of micturitions and UUI episodes. Statistically significant improvements were also seen across the key secondary endpoints, including urgency episodes. Overall, the adverse event rates were comparable between older patients and the total study population. Further presentations of EMPOWUR data are planned for later in the year, including at the upcoming meeting of the International Continence Society in Las Vegas in November of 2020.

I will now comment on our ongoing clinical trials. Since the outbreak of the COVID-19 pandemic, we have been monitoring the situation closely in the regions where our ongoing clinical trials are running. In March 2020, we decided to temporarily halt the screening of new patients for a clinical trial as a precautionary measure. However, for already enrolled patients, trial health continued in alignment with the FDA's guidance on the conduct of clinical trials during the COVID-19 pandemic. We've maintained close communication with our sites and will continue to do so. At the end of April, we began to reopen our trial sites for the screening of new patients and have done this in a stepwise manner. For a Phase III COURAGE development program for vibegron in men with OAB and benign prostatic hyperplasia or BPH, we are now in Part 2 of the trial, in which over 1,000 patients will be involved. The trial is running in North America, and we have begun initiating the first study sites in Europe. Part 2 of this Phase III trial will assess both the efficacy and safety of vibegron in men with OAB and BPH. Co-primary endpoints are the reduction in micturation frequency and urgency episodes for 24 hours. Key secondary endpoints are reduction in nocturia episodes, which is the awakening at night to void, prostate symptom scores and safety. Additionally, the first patients are also enrolling into a long-term extension trial, which will follow patients for a total exposure of 52 weeks. As a reminder, there's currently no FDA-approved product specifically indicated for overactive data in men with BPH.

Regarding our Phase IIa clinical program for vibegron in IBS-associated abdominal pain, the study is enrolling female patients with IBS-associated pain, and following the slight delay due to COVID-19, we now plan to complete the enrollment this summer. Patients are randomized to either 75 milligram of vibegron or placebo. The primary endpoint is a 30% reduction in abdominal pain intensity on a 11-point rating scale over 12 weeks for IBS-D, which is the IBS with diarrhea. A responder is defined as a subject with at least a 30% decrease in worst abdominal pain compared to the weekly baseline average. Secondary endpoints include a global rating scale of safety, in particular, a lack of negative effects of stool frequency or consistency. We now plan to report top line data from this study in the fourth quarter of 2020.

I will now be moving on to URO-902. The Phase IIa trial for URO-902, our novel injectable gene therapy product candidate for patients with OAB who are failed oral pharmacologic therapy has also resumed enrollment after the pause in screening of new patients we previously mentioned due to COVID-19. This is a randomized, double-blind, placebo-controlled trial that will evaluate the efficacy, safety and tolerability of a single administration of URO-902. This therapy is administered via direct (inaudible) injections to the bladder wall under local anesthesia. The trial is expected to enroll approximately 80 female patients [with IBS] in 2 cohorts. The first cohort will receive either single administration of 24 milligram of URO-902 or matching placebo, and the second cohort will receive 48 milligram of URO-902 or matching placebo. The primary outcome measure is the change in the average daily number of UUI episodes from baseline at week 12 as well as assessment of the safety and tolerability of this new potential therapy. Patients will then be followed for up to 48 weeks after 1 injection. The decision to move from cohort 1 to cohort 2 will be made on the recommendation from the independent data safety monitoring Board, or DSMB, which is now planning to meet in the fourth quarter.

Overall, I'm pleased with the progress we made and look forward to providing you with further updates in the coming quarters. Now I'll pass on to Ajay for a financial update.

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Ajay Bansal, Urovant Sciences Ltd. - CFO & Senior VP of Business Development [5]

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Thank you, Cornelia. In addition to the financial results summarized in our press release, you can find additional information, including full year information in our upcoming Form 10-K, which will be filed tomorrow. R&D expenses were $29.5 million for the fourth quarter of fiscal 2019 compared with $22.9 million for the same period in the prior year. R&D expenses were $92.4 million for the full fiscal year 2019 compared with $92.2 million for the prior year.

In the fourth quarter of 2019, R&D expenses comprised of our ongoing studies in OAB plus BPH and an abdominal pain associated with IBS. We also included a $10 million milestone payment made to Merck upon the acceptance of a new drug application for vibegron by the FDA. When comparing the fiscal fourth quarter of 2019 to the same period in the prior year, the increase in R&D expenses is primarily due to the Merck milestone payment and an increase of $4 million in drug substance and other starting material costs for the manufacturing of our initial validation batches of vibegron. These increased expenses were partially offset by lower clinical study costs of $6.6 million, primarily due to the completion of Phase III EMPOWUR study in fiscal 2019.

G&A expenses were $16.7 million for the fourth fiscal quarter of 2019 compared with $5.9 million for the same period in the prior year. G&A expenses of $46.3 million for the full fiscal year of 2019 compared with $18.6 million for the prior year. When comparing the fourth quarter of 2019 to the same period in the prior year, the increase in G&A expenses is primarily due to an increase of $4.4 million in share-based compensation and increases in the personnel costs and other general and corporate expenses. When comparing fiscal year 2019 to the prior year, the increase in G&A expenses is primarily due to an increase of $14.7 million in share-based compensation as well as increases in personnel costs and other general and corporate expenses.

Total operating expenses of $46.2 million for the fourth quarter of 2019 and $138.7 million for fiscal year 2019 compared with $28.8 million and $110.8 million for the same period in the prior year.

Net loss was $51.3 million or $1.68 per share for the fourth quarter of 2019 compared with a net loss of $29 million or $0.96 per share for the same period in the prior year. Our net loss for fiscal 2019 was $146.7 million or $4.82 per share compared with a net loss of $111.3 million or $4.43 per share for fiscal 2018.

Cash used in operations was $31.6 million for the quarter ended March 31, 2020, an increase of $8 million as compared to the immediate prior quarter ended December 31, 2019. Cash used in operations was $102.1 million for fiscal 2019. At March 31, 2020, total cash was $51.4 million. In early April, we added to this cash position by drawing down $41 million from a low interest, 5-year term loan facility with DSP. We now have $171.5 million remaining under the DSP loan facility.

Looking ahead, we expect our operating expenses and cash burn to increase significantly throughout fiscal 2020 as we prepare for the potential December approval and subsequent launch of vibegron in the first quarter of 2021. We project that expenses for full fiscal 2020, excluding share-based compensation expenses as follows: R&D expenses are projected between $90 million to $95 million. These estimates include manufacture of trade product and samples completed prior to approval of vibegron as well as expenses related to ongoing clinical studies. SG&A expenses are projected to be between $90 million to $100 million as we develop our commercial infrastructure, launch our marketing programs and hire our sales force.

In addition, approval of our NDA will trigger a $14 million milestone payment to Merck. And we expect to incur interest payments of between $9 million to $10 million to DSP. Taken together, our cash burn for fiscal year 2020 is projected to range between $200 million to $220 million.

With that financial update, I would like to turn the call back over to Jim.

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James A. Robinson, Urovant Sciences Ltd. - Principal Executive Officer & Director [6]

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Thank you, Ajay. As we prepare to go to your questions, I'd like to summarize how we're thinking about what we've accomplished and the next 6 months to come. We're pleased with the progress we've made so far and the strides we continue to make across all aspects of our business. We're continuing to build out our commercial team and finalize launch plans, and we have several milestones in the back half of the year that will continue to drive us forward. These include top line safety data from the Phase IIa study of vibegron for the treatment of IBS-associated pain, the expected completion of cohort 1 enrollment in the Phase IIa of our novel injectable gene therapy for OAB, URO-902 and potential approval of vibegron in late December.

In summary, we believe we are well positioned to be a strong, leading competitor in this market and are excited about the future.

And with that, operator, we finished our prepared remarks, and we'll now go to questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question is from Eric Joseph with JP Morgan.

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Eric William Joseph, JP Morgan Chase & Co, Research Division - VP & Senior Analyst [2]

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I was just hoping you could elaborate a little bit further on the terms of the agreement announced this morning with Sunovion and what impact, if any, there is on the product P&L for vibegron, and just what the impact might be to commercial margins? And secondly, I'm just wondering if you could sort of just give us your latest thoughts on sizing of the sales force on the heels of this agreement, announced Sunovion as well?

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James A. Robinson, Urovant Sciences Ltd. - Principal Executive Officer & Director [3]

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Great. Eric, it's Jim Robinson. Thanks for your question. In terms of the Sunovion agreement, I'll start, and Ajay can answer some of it as well. But first of all, we're very pleased to have reached agreement with Sunovion. As we said in the press release, they have well-established commercial capabilities. The capabilities that we're working with them on, as we speak, are areas, first and foremost, in logistics. So that's the 3 PL, so the management of the distribution of our product vibegron. Also, we'll be partnering with them on the wholesaler distribution and retail distribution aspects that are important for us to ensure availability of our product across the country. And we'll also meet working with them on select account management capabilities, especially in the areas of group purchasing organizations where they have such strong relationships. And they'll also be our provider for some very important back office services, specifically contract operations, where they're going to be responsible for helping us with rebates, charge backs and government price reporting. So very pleased to have the ability to work in partnership with Sunovion to address these very important capabilities to ensure a successful launch of vibegron. In terms of margin and savings, I'll turn it to Ajay, but on a global basis, the benefit of working with Sunovion is the ability to really avail ourselves of their well-established capabilities without having to build them ourselves. In addition to that, there's strong relationships with and distribution, specifically, the big 3 wholesalers are going to be critically important for our launch. And since they have the presence and they already have agreements in place, it's also a very important efficiency for us to gain. I'm not sure, Ajay, if you want to add any more comments to that.

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Ajay Bansal, Urovant Sciences Ltd. - CFO & Senior VP of Business Development [4]

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No, Jim, I think you have summarized it very well. In terms of the margins, Eric, that Jim was speaking to, hopefully, we'll -- because of their scale, we'll be able to enjoy superior discounts to wholesalers and trade than we would have if we were to go on our own.

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James A. Robinson, Urovant Sciences Ltd. - Principal Executive Officer & Director [5]

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And then I'll address the sales force side thing as well, Eric. So as we've stated in the past, we feel we're very well positioned as we build our sales force of 160 sales professionals with the original -- or the initial footprint will be urology, which is very important to the launch. That will be 120 or 210 urology sales force, sales professionals. And we'll also be building a long-term care sales for us. So that, as we've stated before, we'll be roughly 30 to 50 representatives. We'll also be able to, with that 160 representatives, also call on the high decile, high-prescribing primary care physicians. And so we'll be able to address at launch, greater than 50% of the addressable market at launch.

We're also, as we've discussed in the past, evaluating partnerships in primary care and evaluating the opportunity to have a primary care sales force for vibegron at launch. And as we progress on that strategy and/or make decisions, we'll make sure that we communicate that as well.

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Operator [6]

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Our next question is from Raghuram Selvaraju with H.C. Wainwright.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [7]

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I just wondered if you could perhaps provide us with a bit more granularity on certain aspects of the service agreement with Sunovion, particularly with respect to select account management activities, if you could describe for us in a bit more detail what that means?

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James A. Robinson, Urovant Sciences Ltd. - Principal Executive Officer & Director [8]

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Sure. Thanks, Ram. So thanks again for the question. From a global perspective, at Urovant, we announced a week or so ago, the hiring of Ken Stewart. Ken will be our Senior Vice President of Market Access. We're right now in the process of building a national account. So that national accounts team will be responsible for your national payers. It will also be responsible for the large regional payers. Our primary focus will be on Medicare Part D and commercial, but also be a strong focus in long-term care, especially in the GPO space. So where we will partner with Sunovion, will be first in that GPO space. They have strong relationships. And so we'll conduct joint calls with our Sunovion colleagues to ensure that we have the adequate coverage for these GPOs. And then if necessary, we'll provide the responsibilities among either the Urovant account manager or the Sunovion account manager. They'll also be responsible for managing the trade account relationships solely. So they'll be responsible for wholesaler relationships as well as retail distributor relationships. That will be the Sunovion responsibility.

So in some cases, we'll have shared responsibility like in the GPO space, and in some cases, they'll go at it alone. And from a national accounts perspective, we'll manage the national accounts.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [9]

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Okay. Great. That's very helpful. Also I wanted to know if you could perhaps detail what pre-launch activities are likely to be accomplished prior to the PDUFA date, and which of these are to be conducted in conjunction with Sunovion versus independently?

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James A. Robinson, Urovant Sciences Ltd. - Principal Executive Officer & Director [10]

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Yes. So good question. So we will start this summer in earnest in engaging as appropriate with preapproval information exchange with our national accounts and regional accounts team. So as allowed and required, we'll make sure that we're out as appropriate sharing what we can about the buy background clinical profile in advance of PDUFA. That will be a very important activity for us.

In addition, that we'll be partnering with Sunovion as we start to engage in building out how we're going to address the relationship with managing distribution, managing the back-office functions. So a lot of that will be behind the scenes as we prepare for launch to ensure that we're fully operational at launch. In terms of other activities leading up to launch, other very critical activity, we'll be building out our sales organization. So we'll be expanding our sales leadership team. We'll be expanding our regional sales manager team, and we'll be hiring a full 160 sales force in anticipation of PDUFA of December 26. We'll hire that sales force contingent upon the approval.

So there will be contingent offers made and upon approval of those offers will then go out.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [11]

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Okay. And then last one is, has the failure of linaclotide under the name MD-7246 been viewed as helpful for the competitive positioning of vibegron in IBS-associated pain? Or do you not really view that as having had any kind of impact or long-term impact?

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James A. Robinson, Urovant Sciences Ltd. - Principal Executive Officer & Director [12]

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That's a really good question, Ram. I'm going to have Cornelia to start that, if that's okay. Cornerlia?

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Cornelia Haag-Molkenteller, Urovant Sciences Ltd. - Chief Medical Officer of USI [13]

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This is Cornelia. So first of all, lenaclotide is actually indicated for IBS constipation. This is not what we're studying. This compound, to our knowledge, and you can look it up was a different formulation of linaclotide, it still is linaclotide. And we are studying IBS-D, diarrhea and IBS-M. We do not think that this is related because the mode of action is totally different between these compounds, between lenaclotide and vibegron. I'll hand back to Jim on competitive considerations. And again, our study is a Phase IIa proof of concept. I'd like to reiterate that again, please.

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James A. Robinson, Urovant Sciences Ltd. - Principal Executive Officer & Director [14]

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Yes. So as Cornelia said, in different compound, we feel comfortable. It's where we are today, there's still a significant unmet medical need in large addressable market.

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Operator [15]

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(Operator Instructions) We have a follow-up from Ram Selvaraju from H.C. Wainwright.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [16]

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Yes. Just 2 very quick items for me. Cornelia, maybe you can just remind us how quickly you expect Part 2 of the COURAGE study to complete enrollment? And also, if you can just run through the types of drugs that are excluded from the URO-902 OAB trial?

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Cornelia Haag-Molkenteller, Urovant Sciences Ltd. - Chief Medical Officer of USI [17]

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Okay. So we have given guidance that we will provide results of the COURAGE study, which is the OAB plus BPH study in the second half of 2021. This is our current guidance. As you know, we are still in the year 2020, and I think we're going to give more guidance about when we anticipate the end of enrollment towards the end of this year, early next year. Regarding URO-902, these are patients who have failed oral pharmacologic therapy. So they do not longer take any oral or transdermal drug. They will not have any concomitant medication for overactive bladder at the same time. This is an injectable therapy directly into the bladder. It's a very focused direct therapy.

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Operator [18]

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Our next question is from Jeet Mukherjee with Jefferies.

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Suranjit Mukherjee, Jefferies LLC, Research Division - Equity Associate [19]

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This is Jeet on for Biren. I think you perhaps were hinting at this, but if you could provide a little bit more color on any discussions with payers you've had to date and what those conversations have been like? And then second, on pricing, have you had any discussions or conversations on that? And would you consider a discount to Myrbetriq perhaps?

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James A. Robinson, Urovant Sciences Ltd. - Principal Executive Officer & Director [20]

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Yes. So good question. Thanks for it. We -- as I mentioned, we'll begin in earnest our preapproval information exchange activities in the summer. But we are in the process of building out our national accounts team and we just hired the head of market access. So we'll have much more information towards the end of this year in terms of the perspective clinically on vibegron, its value proposition and whether it resonates with payers, which we believe it will and the be able to have a better sense of what the dynamics need to look like for us to successfully secure formulary access, which would also include pricing at that time.

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Operator [21]

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And with that, I will pass the call back to Mr. Jim Robinson for his final remarks.

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James A. Robinson, Urovant Sciences Ltd. - Principal Executive Officer & Director [22]

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I want to say thank you for everyone for joining our call today, and we appreciate the engagement and the questions, and we look forward to our next call coming up in the near term. Thanks very much.

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Operator [23]

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Thank you, again, ladies and gentlemen, for participating in today's program, and you may now disconnect. Good day.