Urovant Sciences Limited (UROV) CEO Keith Katkin on Q4 2018 Results - Earnings Call Transcript

About: Urovant Sciences Ltd. (UROV)
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Earning Call Audio

Urovant Sciences Limited (NASDAQ:UROV) Q4 2018 Earnings Conference Call June 13, 2019 4:30 PM ET

Company Participants

Christine Ocampo - Senior Vice President and Chief Accounting Officer

Keith Katkin - Chief Executive Officer

Cornelia Haag-Molkenteller - Chief Medical Officer

Michael McFadden - Chief Commercial Officer

Conference Call Participants

Jeet Mukherjee - Jefferies LLC

Ritu Baral - Cowen and Company

Eric Joseph - JPMorgan

Raghuram Selvaraju - H.C. Wainwright & Co, LLC


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

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

Christine Ocampo

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

After the close of market today, Urovant issued a press release containing detailed information on results. You may access this release on our Company website, urovant.com.

Today's remarks contain forward-looking statements, including statements regarding our plans and strategies for the clinical development of vibegron and another treatment for urologic diseases. I direct your attention to the forward-looking statements disclosure in today's press release and the Risk Factor section of the quarterly report on Form 10-Q, which was filed with the SEC in February 2019 as well as the Form 10-K, which will be filed with the SEC in the near-term for a review of the various risks and uncertainties that could cause actual results to differ materially from projections.

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

Keith Katkin

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

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

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

Furthermore, during the past quarter, we gained alignment with the FDA on the proposed Phase IIa protocol for our novel gene therapy product for OAB, URO-902. And finally to further our cash runway, we secured a debt finance agreement with Hercules Capital for up to $100 million.

With that, I'll now turn the call over to our Chief Medical Officer, Dr. Cornelia Haag-Molkenteller who will provide a more detailed update on our clinical programs. Cornelia?

Cornelia Haag-Molkenteller

Thank you, Keith. We continue to make excellent progress across all four of our clinical development program. First, I would like to talk about our international EMPOWUR Phase III trial for vibegron adults with overactive bladder. The EMPOWUR study, our pivotal Phase III study in OAB completed in early 2019 and we announced positive topline results in March.

The primary efficacy analysis, once-daily vibegron 75 milligram met the co-primary endpoints at week 12, achieving statistical significance compared to placebo on both reduction in daily urinary urge incontinence episodes, a key symptoms for patient seeking OAB treatment and daily micturitions.

The difference from placebo for both daily UUI episodes, which are the Urge Urinary Incontinence episodes and micturitions was highly statistically significant by week 2, which was the first timepoint measured and efficacy for both primary endpoints was maintained at all timepoint measured throughout week 12.

Moreover, the subgroup analyses for both co-primary variables showed efficacy in patients above 65 years of age, patients with prior anticholinergics and patients with prior mirabegron. All seven pre-specified secondary endpoints were also met, including statistically significant reduction in daily urgency episodes, the most important secondary measure.

Also vibegron significantly increased the volume voided per micturition over placebo, which is an important and objective pharmacologic parameter for OAB drugs. Vibegron was also well tolerated in the Phase III. The most common adverse events were at or below 4% included headache, nasopharyngitis, diarrhea and nausea. The frequency of serious adverse events was similar across treatment arms. Also the incidence of the reported adverse events of hypertension was equal to placebo, which is 1.7% in vibegron and 1.7% in placebo.

The EMPOWUR study was recently presented at the American Urological Association meeting by Dr. David Staskin from Boston, as a breaking news in the plenary session. Further presentation and full publication of the study are planned. The long-term extension study is still ongoing and results expected towards the end of the third quarter.

New Drug Application also called NDA, preparations are continuing well with the targets submission in the first quarter of 2020. Of note, we are also exploring all options to accelerate this timelines to the end of the fourth quarter of 2019.

Second, we have our OAB program for men with Benign Prostatic Hyperplasia or BPH. This is an important supplemental development program for vibegron, because there is currently no FDA approved product specifically indicated for overactive bladder in men with BPH.

The co-primary endpoints are reduction micturition frequency and urgency episodes for 24 hours. Key secondary endpoints are reduction in nocturia episodes, which is the awakening at night devoid, prostate symptom scores and safety.

Given the limited clinical data available in men with OAB and BPH, we aligned under two-part trial with the FDA. In Part 1, we will assess initial safety in 80 patients via an Independent Data Safety Monitoring Boards. In Part 2, we will assess safety and efficacy in all patients. Part 1 started enrolling in March 2019 and is expected to complete in the fall of 2019.

Next regarding our clinical program for IBS-associated abdominal pain, we started enrollment into a Phase IIa study in December 2018. We plan to enroll 200 female patients with IBS-associated pain due to IBS with diarrhea or mixed IBS. Patients will be randomized to either 75 milligram of vibegron or placebo.

The primary endpoint is a 30% reduction of abdominal pain intensity on an 11-point rating scale at week 12 for the IBS-D. The 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 the global rating scale and safety in particular also negative – lack of negative effects on the stool frequency or consistency. Enrollment continues to go well and we expect it to report topline data in 2020.

Lastly, in the first quarter of 2019, we received feedback from the FDA on development and proposed Phase IIa protocol for a novel gene therapy product for OAB, called URO-902. The FDA was generally aligned with our plan and we expect to start patient enrollment towards the end of the first quarter 2019.

With that, I'll turn the call over to our Chief Commercial Officer, Michael McFadden.

Michael McFadden

Thanks, Cornelia. We continue to be excited about the commercial opportunities for vibegron. Beta-3 agonist market share continues to increase and new patients consistently enter pharmacologic treatment in a large OAB category.

Also we continue to observe this high patient turn with existing treatments in the OAB class, further adding to the great opportunity, a potential new treatment like vibegron, which if approved will be the first new oral OAB product in eight years.

Post the EMPOWUR study topline data release, we conducted an in-depth qualitative market research study across 42 physicians including both OAB thought leaders and prescribing physicians to ascertain their opinions about the vibegron data.

The market research results support our belief that vibegron, if approved, will represent a highly differentiated options for physicians treating OAB. Specifically, the interviewed physicians believe vibegron, if approved, would represent a clear choice over the Myrbetriq based on vibegron's rapid 2-week onset versus Myrbetriq’s 8-week onset.

In addition, the interviewed doctors rated UUI episodes volume voided data, urgency and responder secondary endpoints as top differentiators versus Myrbetriq. Vibegron's single dose and lack of titration will also viewed positively by interviewed physicians as simple dosing is always preferred. And vibegron's safety profile was rated highly by the interviewed physicians and is expected to be a significant decision-making factor on its own.

The results of this market research confirm our thinking about the strength of the pivotal trial results and our commercial team's ability to differentiate vibegron from the currently available OAB medications. Our plan is to commercialize vibegron in the United States with urology and long-term care specialty sales forces that will focus on physicians who treat high numbers of OAB patients.

We believe we can deliver this footprint with approximately 150 sales personnel, which will provide a significant reach in the both segments. And both segments combined represent a potential market in excess of $3 billion. We plan to demonstrate success in these segments first and then either bolt-on or partner our primary care and internal management sales force.

Now I'd like to address the top three commercial questions typically raised about the launch of vibegron. First, how are we going to successfully launch vibegron? The market is large. We estimate over 8 million patients have failed one to two pharmacologic therapies. We will market to these patients directly and through partners to alert them of a new therapy option.

Additionally, we'll target our sales force urologists and long-term care providers that are seeing high numbers of patients with OAB. Our indicational efforts will target these practitioners to educate them on vibegron. And lastly, we will utilize our expertise and manage markets to obtain access so the patients will have access to vibegron with an affordable co-pay.

Second question that we receive, how can we effectively compete with Astellas? With regard to Myrbetriq, the beta-3 competitor, we plan to match Astellas share of voice among urologist as well as via new and dominant share of voice and long-term care. The share voice is important in this category, and we believe we can effectively compete with an efficiently sized sales force.

Third, how can we compete in a generic market? Although the OAB treatment market has been highly genericized for decades, several blockbuster drugs have entered this market over the years, which is further evidence that OAB continues to remain a market with a high unmet need, high patient turnover rate, high adverse events from anticholinergics medications and a very large market size of 18 million prescriptions provide a great market dynamic for new products.

Now I'll pass to Christine for financial update.

Christine Ocampo

Thank, Michael. In addition to the financial results summarized in the press release, you can find additional information including full-year information and our upcoming Form 10-K, which will be filed with the SEC in the near-term. Research and development expenses were $22.9 million for the fourth quarter of 2018 compared with $16.4 million for the same period in the prior year.

Research and development expenses were $92.2 million for the fiscal year 2018 compared with $32.4 million for the prior year. In the fourth fiscal quarter and the full fiscal year of 2018, research and development costs were primarily attributed to our ongoing Phase III EMPOWUR trial of vibegron in adults with OAB.

General and administrative expenses of $5.9 million for the fourth quarter of 2018 compared with $2.7 million for the same period in the prior year. General and administrative expenses were $18.6 million for the fiscal year 2018 compared with $4.6 million for the prior year. When comparing the two fiscal years, fiscal 2017 did not reflect a full-year of G&A cost associated with the establishment of our U.S. headquarters in Irvine, California and the related personnel costs as the office was not opened until the middle of the fourth quarter 2017.

Total operating expenses for the fiscal year and fourth quarter of 2018 were $110.8 million and $28.8 million respectively compared with $37 million and $19.1 million for the same period in fiscal 2017.

Cash used in operations decreased by $16.7 million to $24 million for the quarter ended March 31, 2019 as compared to the previous quarter that ended December 31, 2018. Our net loss for the fiscal fourth quarter of 2018 was $29 million, or $0.96 per share, compared with the net loss of $19.1 million or $0.95 per share for the same period in fiscal 2017.

Our net loss for the fiscal 2018 was $111.3 million or $4.43 per share compared with a net loss of $37.1 million or $2.16 per share for fiscal 2017. We closed our debt financing facility for up to $100 million for Hercules Capital in February, resulting in net proceeds of approximately $14.1 million received at closing.

Following the announcement of the positive topline results from the EMPOWUR study, we are able to draw an additional $30 million under the debt facility anytime through September 30, 2019. As of March 31, 2019, our total cash and cash equivalents balance was $85.4 million or $115.4 million with the $30 million available from Hercules.

Looking ahead to the first quarter of 2019, we currently expect our total operating expenses to remain consistent at $27 million to $29 million. As we close out our Phase III EMPOWUR trial and continue our Phase IIa 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, which was initiated in March. We expect our cash used in operations in the first quarter of 2019 to be approximately $23 million to $24 million.

With that summary of our financial results, I'd like to turn the call back over to Keith for closing remarks.

Keith Katkin

Thanks, Christine. To build on Christine's financial comments, I also wanted to comment on how we're thinking about our current capital plan. We're obviously very disappointed with our current stock price and do not think it reflects the true value of Urovant.

As such, we do not want to do a financing at these levels in the near-term as we think it will legitimize the stock price. We are fortunate that we have a strong financial background in our parent company Roivant and do not need to be in a rush to do a financing at the current stock price levels.

In addition, we believe that we have a number of milestones later this year and in 2020 that can meaningfully impact the stock price. We are also pleased to see that Roivant recognizes how undervalued our stock is at the current time and is demonstrating their conviction by buying stock in the open market.

Now to recap, in the fourth fiscal quarter, we achieved significant key milestones across all aspects of our business. As I mentioned before, we look forward to a number of upcoming milestones that will continue to drive us toward the goal of developing Urovant into a leading specialty urology company.

These milestones include completion of the EMPOWUE Phase III extension study in late summer, continuing enrollment in both our Phase III OAB BPH study and our Phase II IBS-associated pain study, with data from the IBS pain study expected in 2020, and filing our NDA for vibegron in OAB in the first quarter of 2020, while trying to accelerate that filing into the fourth quarter of 2019.

With that summary of milestones, I'll now open the call to questions. Operator?

Question-and-Answer Session


Thank you. [Operator Instructions] Our first question comes from the line of Biren Amin of Jefferies. Your line is open.

Jeet Mukherjee

Hi, guys. This is Jeet on for Biren. Thanks for taking our question. Just wanted to know if you could provide any additional color on physician and payer feedback following the EMPOWUR readout and what data points might [have split out] in particular to them compared to mirabegron? Thanks.

Keith Katkin

Yes. So we conducted a qualitative market research of 42 physicians, both thought leaders and prescribing physicians and reviewed the topline data with them. They also were aware – these physicians were aware of other products in the market and what their data was in the context of that research. And the physician feedback was very clear. They felt that the product if approved will represent a clear choice versus Myrbetriq and I believe it already would represent a clear choice versus anticholinergic.

And I think the attributes that were called out by the physicians is most impactful were 2-week onset versus Myrbetriq’s 8-week onset. They also – physicians commented that the UUI data, volume voided data, urgency and responder secondary endpoints were key differentiators and were – represented really robust efficacy numbers. Additionally, the safety profile was viewed as favorable by those physicians. And last but not least, they commented that any drug that does not require titration, single dose and starting dose is preferable for their practice.

Jeet Mukherjee

Okay. Thank you.


Thank you. Our next question comes from Edward Nash of SunTrust. Your line is open.

Unidentified Analyst

Hey. This is [indiscernible] on for Edward. Did you have any early discussion with payers with regard to how vibegron is likely going to be reimbursed?

Keith Katkin

So we completed an initial payer research last summer. We did that with two different payer research studies, both of which came back with the exact same output from the study. They represent over 160 million payer lives in the U.S. both commercial and Medicare D.

And the payers shared with – they offer that research was really threefold: One, they don't view the class as one that they highly manage or regulate, they view it as very predictable for their [auctorial models] to manage and price the class for employers and patients; and third, they manage the class with co-pay differential today and will continue to do so in the future meaning that if a patient chooses to fill a branded script, they prefer to differentiate the branded script from a generic with co-pay differential.

They don't actively manage the class with prior authorizations or stuff added, and we believe that is due to the pricing of the class and the predictability of the class. And indeed, we've quantified that the results of that research by looking at how drugs in the class are covered and they are covered with no restriction in over 90% of covered lives. And that includes Myrbetriq, it included and it includes [indiscernible]. So the payers are telling us pre-open class relative to many others that they manage. We have not done completed research with the payers post topline data, but we will do that work in the fall of this year.

Unidentified Analyst

That's very helpful. And then secondly, so basically you present some data of efficacy in some key subpopulations. Is there anything you would like to highlight or call out?

Michael McFadden

Yes. So I think what we were very excited to see in that or we focus particularly on three subpopulations: The first, patients that are 65 years or older. Obviously, that is a delicate patient population that we've been clear profiler of vibegron, if approved would work very well. And in that population, we're very pleased to see that a strong treatment effect in that group.

Additionally, one question that we get to ask very frequently is what about patients that have been on prior therapy either in prior anticholinergic therapy or even more importantly, prior mirabegron therapy. And so we were pleased to report that in both of those groups, we also saw a very strong treatment effect. And so we think that's a very meaningful commercially. One, obviously you would expect that anticholinergics and if even people failed anticholinergics that the beta-3 at vibegron would work, so that was good to confirm that.

And then second, we often get to ask if the patient does not successful on mirabegron, then will they be successful on vibegron? And I think that these data show a very strong treatment effect and for patients that were previously on mirabegron when treated with vibegron. So we think that positions us very well as we move forward towards launch.

Unidentified Analyst

Great. Thank you so much.

Keith Katkin

Thank you.


Thank you. Our next question comes from Ritu Baral of Cowen. Your line is open.

Ritu Baral

Good afternoon, guys. Thanks for taking the question. I wanted to ask about a couple of things. One, what's left to do on the NDA filing? And also, you mentioned that you might be able to expedite this. What are the leverage points for potentially expediting the filing? And then I've got a follow-up.

Keith Katkin

Sure. So in terms of left-to-do, three things that are needed in order to file the NDA: The first is completion of the open-label extension study, which we should have late in the summer. The second is the ambulatory blood pressure study that was requested by the FDA, which that too we should have late in the summer.

And then the last, which is actually the critical path item, is stability on the new 75-milligram dose. And so that is the – what would potentially allow us to accelerate into Q4 is essentially how quickly we can move the stability data once we get it into the NDA.

Obviously, we want to make certain that the NDA is perfect when it's submitted the links work and then if the highest quality document possible. So it really blows down to how long it will take us to get that stability data into the NDA as everything else will be complete just waiting on the stability data.

Ritu Baral

The ambulatory blood pressure study, is that open-label? Are you able to monitor that? Is it perceived?

Keith Katkin

It is a double-blind study. As a reminder, over 200 patients, and we'll be obviously thoroughly monitoring blood pressure at multiple timepoints and multiple visits to understand what if any impact that vibegron has on blood pressure.

And just as a reminder, our going-in assumption is that we'll see some very minimal increases much like vibegron saw in their studies, which could result in similar labeling. That said, we do think it would be a very significant upside event if no blood pressure changes were observed in the study.

Ritu Baral

Got it. Moving to commercial, you mentioned the – right now the estimated sales force size is about 150 reps. Can you talk about the number of potential targets that you guys have in mind? You mentioned urologists, are there any high-prescribing PCPs also targeted in the current plan? And how do you think about potentially tearing the calls of those 150 reps?

Keith Katkin

Yes. It's a great question, Ritu. There are about 7,000 urologists that treat the majority of OAB patients and write the majority of OAB prescriptions, we'll certainly call all of those urologists. And then there are about 1,000 to 3,000 primary care physicians/internal medicine physicians and their supporting Nurse Practitioner and Physician Assistant, ACPs that write a very large majority of the PCP, OAB prescriptions. And we plan to call on both of those with our urology sales force.

And then the other segment that we're going to enter is long-term care. We feel like we can do that with a 50-person in sales force and we can cover about half of the bed lives in long-term care directly. And then a substantial portion indirectly with that sales force size.

Ritu Baral

Got it. So the 150 includes those 50 long-term care reps or is that a separate force?

Keith Katkin

It does. No, it can include.

Ritu Baral

Got it, okay. And then last question, how with the additional work you've done over the last few months, how are you thinking about pricing? Or should we all still assume branded parity or are there other factors that play here now?

Keith Katkin

Well, there's still work to be done with the payers this fall and that will certainly inform and expand potentially our thinking on pricing, as of now. I think parity pricing with Myrbetriq plus or minus or bracket of about 20% seems to make sense in this market. But we still need to see the data that is to come with the blood pressure study and have the market research this fall with the payers to solidify our thinking on that.

Ritu Baral

Great. Thanks for taking all the questions.

Michael McFadden

Thank you, Ritu.


Thank you. Our next question comes from Eric Joseph of JPMorgan. Your line is open.

Eric Joseph

Hey, guys. Thanks for taking the questions. I'm just wondering if you could speak to any incremental visibility on the Japanese vibegron launched by Kyorin and any feedback on how that product is being received clinically relative to Myrbetriq whether it's – that is while informing your commercial strategy here in the U.S.? Then I have a follow-up.

Keith Katkin

Yes. Thanks for the question Eric. So we have very limited data on exactly what's going on with the launch in Japan. This is a reminder, it's co-marketed between Kyorin and Kissei Pharmaceutical in Japan. Kyorin actually announces their data and the quarterly revenues.

And so my comment earlier in terms of the success of the Japanese launches, in their first full quarter of launch, they actually posted some pretty attractive revenue numbers in that first quarter. We're just not certain if it's a combination of all the sales between Kyorin and Kissei or if there's a revenue split between the two companies.

But if you do look at Kyorin's forecast for this year, they actually have quite a substantial revenue forecast for vibegron. When you consider that the Japanese market in total is about $300 million a year, they're actually projecting that they get a very nice percent market share in their first year on the market.

Again, we don't have access to IMS or [indiscernible] data in Japan. So we don't have great visibility. But it does look like their first quarter revenue performance was strong and their projections for the full-year revenue performance are quite strong, such that if we achieved similar levels then we'd certainly have an incredibly strong launch here in the States.

Eric Joseph

Got it. And just a follow-up here on COURAGE and then with OAB due to BPH, just wondering to what extent the male subjects that were accrued in EMPOWUR reflect those being recruited to COURAGE? And whether subset-analysis you may have conducted on EMPOWUR. How are you thinking about – I guess expectations around the success of the co-primary endpoint that in COURAGE or micturition and urgency of that?

Keith Katkin

Cornelia, would you like to answer that one?

Cornelia Haag-Molkenteller

Yes. So thank you, Eric. So first of all, the men in our current EMPOWUR study are not totally reflective because of course here in the COURAGE study, we require them to also be on an alpha blocker. They also need to have a minimum number of urgency and micturition and they also need to have nocturia, which was not a requirement from EMPOWUR, so you can't really compare them.

We looked at micturition [indiscernible] urgency as well, looks at least in the right range. However, we do know to look of course at these data more carefully. But at the moment, we're confident in our current co-primary variables that we will continue to look of course.

Eric Joseph

Got it. That's it. That’s helpful. Thanks for taking the questions, guys.

Keith Katkin

Thanks, Eric.


[Operator Instructions] Our next question comes from the line of Ram Selvaraju of H.C. Wainwright. Your line is open.

Raghuram Selvaraju

Thanks very much for taking my questions. Just three very quick one, guys. So with respect to vibegron, I wanted to know whether you could maybe quantify for us what you think the delta or the distance might be between vibegron and mirabegron, if vibegron were to obtain successfully a label for use in patients with concomitant OAB and BPH.

Secondly, if you could give us a sense of what – to what degree physicians would require prior treatment and failure or prior treatment at all with mirabegron in patients who would not be considered particularly good candidates for mirabegron therapy before starting vibegron therapy.

So for example, those patients who either are on concomitant medications would be consider candidates for concomitant medications were there are likely to be drug-drug interactions with mirabegron, whether you think there's any likelihood at all that physicians would continue, sort of, counterintuitively to insist that those patients try mirabegron first before going on vibegron.

And then lastly, a question on URO-902, if you could just give us a sense of what you expect the timing of initiation of the Phase IIa study to be and also whether you can confirm at this juncture whether the route of administration would be similar to what reduced by Ion Channel before or whether it's been changed? Thank you.

Keith Katkin

Thank you, Ram. Appreciate the question. I'll take the first one. I'll let Michael take the second and then Cornelia to take the third one on that. So first off, your first question was about quantifying potential benefit of vibegron in OAB and BPH relative to mirabegron. And there, I don't know if there's – it's not really a question of quantifying the differential.

Right now, there are no approved products for contaminant OAB and BPH. And in our discussions with the FDA, the FDA was very clear. They view that men would have OAB and BPH as a separate and distinct indication from an OAB indication. So what that means is if our study is successful, we will be able to file a sNDA and have essentially a label enhancing indication allowed on the vibegron labels.

And so given the FDA's stance, we don't think that it's – we don't believe that Astellas would promote into that marketplace, which then would make obviously, vibegron the only promoted product into that category. And we do view that as a very large category.

I think as you are aware, 75% of the men that have OAB and BPH, their OAB goes untreated. And so we think that is a very large market opportunity with over 2 million men out there that can benefit from vibegron, if approved for that additional indication.

So with that, let me turn over to Michael to talk about your question about whether or not physicians would maybe require to have or may want prior treatment with mirabegron before prescribing vibegron.

Michael McFadden

Yes. Let me comment on two fronts. First from the payer front, how they’ll view it? And what the physicians have told us in market research. From the payer front, they have shared with us, this is a non-managed class. They managed it with co-pay differential.

And then their [content is to let] each manufacturer, trying to differentiate their product and physician select the product, if they think is best for the patient, whether that's [indiscernible] or generic or whether that is Myrbetriq or ultimately what – if approved with vibegron.

So we believe the differentiation choice for – from a payer standpoint is that non-managed class let the physician that patient work through those issues. From the physician standpoint, when we look at the market, I'll frame the question maybe how we're thinking about it. There are about 14 million active patients that are in the process of seeking treatment has sought treatment or have sought treatment and [indiscernible] on treatment.

There are 3.3 million of those patients that are active meaning, they are taking medicine today. They're filling scripts at a pharmacy. There are about 8 million to 10 million that have failed, one, two and/or three medications.

And so as we think about the market, we will certainly pursue the active patients, the 3.3 million, because we know the medicine they own today, over 70% of them will not be taking that medicine six months from now. And they stop taking it typically for tolerability issues with the old anticholinergics and from Myrbetriq, we know they lose 40|% of our patients by month two.

And so we will actively pursue next choice for those patients as they represent the majority of the market. And then there are about 8 million to 10 million patients who failed everything, and we're actively working on ways to bring those patients back into therapy by sharing information with them, finding them first and then sharing information about a coming therapy.

And ultimately if approved, we'll talk to them about the therapy option of vibegron and ask them to engage their doctor if they want to reengage the therapy. So as we think about, there are a lot of different opportunities across the continuum for us to differentiate the product and then actively pursue different patient types.

And then last, but not the least the long-term care. There is no product in OAB today that has a better profile for the long-term care patient both from a safety and efficacy standpoint. So we believe that vibegron will be highly differentiated in that category, which we believe represents $1 billion potential.

Cornelia Haag-Molkenteller

Okay. So on URO-902, is that correct?

Keith Katkin

Yes, please. It's about – when we're planning on initiating in route of administration.

Cornelia Haag-Molkenteller

Yes. We are planning to initiate towards the end of the year. And the route of administration will be in [particular injections] just as the last of the Ion studies and equivalent to BOTOX and essentially all of that has been established for BOTOX injections, and the local anesthesia is an in-office procedure.

Raghuram Selvaraju

Great. Thank you very much for those nuanced answers. Much appreciated.

Keith Katkin

Thanks Ram. Appreciated.


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

Keith Katkin

Thank you. Just like that, thank you everybody for joining us on our conference call today, and we look forward to seeing everyone at the JMP Conference in New York next week or on our next earnings call. Thank you, everyone.


And this concludes today's conference call. Thank you for your participation, and have a wonderful day. You may disconnect your lines at this time.