UroGen Pharma Ltd. (URGN) CEO Elizabeth Barrett on Q3 2019 Results - Earnings Call Transcript

Nov. 12, 2019 1:25 PM ETUroGen Pharma Ltd. (URGN)
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UroGen Pharma Ltd. (NASDAQ:URGN) Q3 2019 Earnings Conference Call November 12, 2019 8:30 AM ET

Company Participants

Catherine Bechtold - Senior Director of IR

Elizabeth Barrett - President and CEO

Mark Schoenberg - Chief Medical Officer

Peter Pfreundschuh - CFO

Stephen Mullennix - COO

Jeff Bova - SVP, Commercial

Conference Call Participants

Turner Kufe - JPMorgan

Ram Selvaraju - H. C. Wainwright

Boris Peaker - Cowen

Leland Gershell - Oppenheimer


Good morning, ladies and gentlemen, thank you for standing by and welcome to UroGen Pharma's Third Quarter 2019 Financial Results and Business Update Conference Call.

It is now my pleasure to turn the call over to Kate Bechtold, Senior Director of Investor Relations for UroGen Pharma. Please go ahead.

Catherine Bechtold

Thank you, Operator. Good morning, everyone, and welcome to UroGen Pharma's third quarter 2019 financial results and business update conference call. This morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended September 30, 2019. The press release can be accessed on the Investors' portion of our website at investors.urogen.com.

Joining me on the call today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; and Peter Pfreundschuh, Chief Financial Officer. Joining us for the Q&A portion of this call will be Stephen Mullennix, Chief Operating Officer; and Jeff Bova, Senior Vice President of Commercial.

Liz will provide a summary of our recent corporate developments and Mark will share clinical development and regulatory update. Peter will then provide an overview of our financial highlights for the third quarter of 2019 before we open-up the call for questions.

As a reminder, during today’s call, we will be making certain forward-looking statements. Various remarks that we make during this call about the company's future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of UroGen Pharma’s quarterly report on Form 10-Q filed with the SEC this morning, and other filings that UroGen makes with the SEC from time to time.

We encourage all investors to read the company’s quarterly report on Form 10-Q and the company’s other SEC filings. These documents are available under the SEC Filings section of the Investors page of UroGen’s website at investors.urogen.com.

In addition, all information we provide on this conference call represents our views only as of today, and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future events or otherwise.

I will now turn the call over to Liz.

Elizabeth Barrett

Thank you, Kate. Good morning, everyone, and thank you joining our call this morning.

I just like to start by acknowledging the announcement that came out yesterday on our licensing agreement with Agenus, and I'll comment about that in a moment. But I want to open today's call with a news that we have completed the submission of our rolling New Drug Application or NDA to the FDA for our lead product candidate UGN-101 for the treatment of low-grade upper tract urothelial cancer or low-grade UTUC. The FDA has a 60 day filing review period to determine whether the NDA submission is complete, and the company will communicate the FDA's decision by year-end.

UGN-101 is eligible for priority review, and we anticipate a six month review PDUFA date. To that end commercial preparations are on track to support a planned approval and launch in the first half of 2020. If approved, UGN-101 will be the first drug for the treatment of low-grade UTUC and represents a significant advance for the approximately 6,000 patients who may be eligible for the treatment with UGN-101. We're working closely with the FDA and have a high level of engagement thus far.

UroGen recently presented data from a final analysis of the primary endpoint for our pivotal Phase 3 OLYMPUS clinical trial and Mark will discuss in more detail in a few minutes. We remained very excited by the complete response rate, and more importantly, by the strong 6 month and 12 month durability. We are assembling an experienced commercial team, and developed a strong branding and plan to ensure rapid uptake and adoption.

2019 has been a busy year for this team, as they've gathered intelligence and built programs to ensure the seamless integration into the urology practice. As a reminder, we are planning for a nimble sales force of approximately 50 representatives to cover 90% of the patient potential. And we believe that this force will be able to swiftly and effectively reach our target urology practices.

The management team is on board, and we eagerly anticipate the start of the complete team in January. In addition to the sales reps, we will have a small team of nurse educators to provide training and support around installation, as well as field reimbursement managers to ensure access and reimbursement.

Earlier in 2019, we hired a team of MSLs who have appropriately engaged with physicians interested in learning more about UroGen and our technology. Additionally, we launched an educational campaign to establish the unmet need, and low-grade UTUC filling a void among all stakeholders, including clinicians and patients. Based on recent market research we have learned that 88% of urologists desire a new and differentiated treatment option for their patients and current awareness of UGM-101 is 70%, up from 13% a year ago.

As we navigate the world of access and reimbursement. We are pleased with the recent progress at CMS to move to a quarterly review for permanent J-codes and are hopeful that this will be enacted prior to our approval. Regardless, we have developed access programs to support offices and patients, and ensure that any patient in need of our medicine will be able to access it.

We will be prepared for a successful launch by January, and our team is looking forward to bringing UGN-101 to patients and physicians. Beyond our lead product therapy, we're accelerating development of our next potentially transformative candidate UGN-102 for the treatment of patients with intermediate risk, low-grade, non-muscle invasive bladder cancer. We were pleased to recently share positive complete response data on over half of the patients from the Phase 2b OPTIMA study.

In the interim analysis, we observed a complete response rate of 63% with 20 of 32 patients achieving a CR. We completed enrollment of the Phase 2b OPTIMA II Trial ahead of schedule, and will continue to follow these patients with an intent to report durability data at appropriate intervals.

Mark will talk more about the significance of this data to this large patient population of approximately 80,000 patients. But it's important to know that patients with intermediate risk, low-grade, non-muscle invasive bladder cancer have no treatment options, aside from repetitive surgical resection via a Transurethral Resection of Bladder Tumor or TURBT.

Following the interim look at the data, we are requesting a meeting with the agency in the first quarter of 2020 to discuss our registrational path for UGN-102. Based on previous discussions with the FDA, we are preparing a protocol for a head-to-head study of UGN-102 verses TURBT with a recurrent free time as their primary endpoint.

As a leader in the low-grade space, we are focused on delivering UGN-101 and UGN-102 to patients who are in need of innovative non-surgical options. We believe that that peak revenue potential of these products alarm could be greater than $1 billion, providing a strong foundation to build a long-term sustainable growth business.

As a natural progression of our pipeline, we're very excited to announce the exclusive worldwide license agreement with Agenus to Develop and Commercialize Zalifrelimab, AGEN1884 and anti-CTLA-4 antibody in combination with UGN-201 for the treatment of urinary tract cancers via intravascular delivery.

Zalifrelimab is currently being evaluated by Agenus as monotherapy in PD-1 refractory patients. The initial indication for development will be high-grade non muscle invasive bladder cancer, supported by the encouraging pre-clinical data we recently shared. This agreement with Agenus built upon our leadership in uro-oncology and leverages the expertise and capabilities we have built with UGN-101 and UGN-102.

We are preparing for success in a position of strength today as a result of extensive planning and diligent efforts across our nimble company. With completion of the NDA submission, recent data updates and the license agreement, we have taken a major step forward and our mission to bring patients unique solutions that overcome barriers to treat specialty cancers in urologic diseases.

I'd now like to turn the call over to Mark, who will discuss our clinical development programs in more detail. Mark?

Mark Schoenberg

Thank you, Liz.

Starting with UGN-101, the final analysis of the primary endpoint for our pivotal Phase 3 OLYMPUS trial demonstrated a 59% complete response rate in patients with low grade UTUC, which was consistent with our previously presented results. Durability of response was estimated by Kaplan-Meier, to be 89% of six months, and 84% at 12 months after primary disease evaluation.

The estimated median time to recurrence was 13 months and 34 of the 71 patients treated in the study were initially characterized by the treating physician as having endoscopically unresectable tumor. These are the patients who according to the standard of care would be candidates for immediate kidney removal. There are 41 patients who have entered follow up, which is still ongoing.

The most common treatment emergent adverse events included ureteral stenosis, urinary tract infection, hematuria, flank pain, nausea, dysuria, renal impairment and vomiting. The majority of these were characterized as mild to moderate inseverity and transient. These adverse events are familiar to urologist, given the disease being treated and the instruments utilized.

We've been frequently asked about the potential to retrieve patients with UGN-101. To that end, we have initiated a retreatment protocol, as an extension to the OLYMPUS trial. And this study is ongoing.

Looking at UGN-102, we are very encouraged by the initial CR data from the Phase 2b OPTIMA 2 trial in patients with intermediate risk, low-grade, non-muscle invasive bladder cancer.

In this cohort of 32 patients, 63%, or 20 patients achieved the complete response. In the interim analysis, the most common treatment emergent adverse events observed word dysuria frequency of urination, fatigue, crematoria, and urinary tract infection. The majority were mild or moderate and transient.

It's important to highlight that intermediate risk, low-grade, non-muscle invasive bladder cancer is emerging as a specific clinical entity characterized by frequent recurrence that is difficult to control using standard care interventions, intermediate risk disease has a number of distinguishing features, including multifocality or tumors greater than three centimeters and rapid rates of recurrence.

The contemporary standard of care for these patients is repetitive TURBT a few patients in the U.S. received Agenus intravesical chemotherapy. The end result is a population of patients, perhaps as many as 80,000 annually, who are consigned to chronic surgical intervention to manage their bladder cancer.

Based on the data observed in the interim analysis, we believe, UGN-102 has the potential to have an immediate impact and provide these patients with a first line, non surgical option for the treatment of chronic relapse. We plan to review trial design options for a pivotal Phase 3 trial of UGN-102 with the FDA in the near future.

As you read in the release and Liz mentioned, we are excited to add an anti-CTLA-4 antibody to our portfolio to study in combination with UGN-201, a TLR7/8 Agenus in high-grade non-muscle invasive bladder cancer, based on encouraging preclinical data we shared in September. We are currently designing Phase 1 clinical trials for patients with high-grade non-muscle invasive bladder cancer, and we'll provide further details on this program at a later date.

As a practicing urologist, who has spent his career treating patients with Urinary Tract Cancers, it is exciting to be part of a program bringing novel therapies to patients who have seen little innovation in the past 20 years. Our portfolio of UGN-101, UGN-102, and the combination of UGN-201 with xenophilemad establishes UroGen as a leader in urologic cancers.

And with that, I would like to turn the call over to Peter, who will discuss the financials.

Peter Pfreundschuh

Thank you, Mark.

And good morning to everyone on today's call. UroGen is well capitalized to advance our clinical development programs as well as our commercial planning efforts in preparation for potential U.S. approval and launch of UGM-101 in 2020. We closed the third quarter of 2019 with $221.7 million in cash, cash equivalents and marketable securities.

For the third quarter and the nine months in September 30, 2019, we reported net loss of $22.3 million, or $1.06 per share, and $66.2 million or $3.25 per share, respectively. This compares to net losses of approximately $20.5 million, or $1.28 per share and $51.9 million, or $3.30 per share for the same periods in 2018. The net losses for the third quarter in the nine months ended September 30, 2019, include $7.2 million, and $21.9 million respectively in non-cash stock-based compensation expense.

Research and development expenses for the third quarter and nine months ended September 30thm 2019 we're $9.5 million and $29.2 million, respectively compared to $9.6 million and $25.5 million for the same periods ended September 30th, 2018 and included $6.4 million and $9.1 million in non-cash stock-based compensation expense respectively.

Excluding stock-based compensation expense, the year-on-year increase from 2018 to 2019 was attributable mainly to costs associated with UGN-101 Phase 3 clinical trial, increased clinical activity for UGN-102 Phase 2b clinical trial, and an increase of headcount and related costs supporting increased clinical trial activities.

General and administrative expenses for the third quarter and nine months ended September 30th, 2019 were $14 million and $40.5 million respectively as compared to $10.7 million and $27 million for the same periods in 2018 and includes $15.5 million and $12.7 million in non-cash stock-based compensation expenses respectively.

The increase from 2018 to 2019 was attributable mainly to increase in personnel and related costs to support our growing business and increase in commercialization infrastructure and services, and an increase in consulting and other outside fees, as well as an increase in stock-based compensation expense.

As of September 30th, 2019, we had approximately 20.9 million ordinary shares outstanding. Including the recently announced Agenus deal, the company is still on track to end the year with a net loss for the year in a range of $100 million to $110 million, which is expected to include non-cash stock-based compensation expense in a range of $28 million to $30 million subject to market conditions. Based on our current plans, we still project our cash balance and carry us through a successful launch of UGN-101 and well into 2021.

With that operator, I would like to turn the call over for questions.

Question-and-Answer Session


[Operator Instructions] And our first question comes from Eric Joseph from JPMorgan. Please go ahead.

Turner Kufe

Good morning, this is Turner on for Eric. Thank you for taking my question. Just heading into the FDA meeting in 1Q 2020 to discuss the role Phase 3 one or two study. I'm just hoping you could elaborate on the choice of recurrence free time as the primary endpoint, instead of six or 12 months CR rates? And whether you would test for both non-inferiority or superiority to TURBT? And then additionally would you plan to enroll patients who are treatment-naive or would you also include patients who have relapsed post-TURBT. Thank you.

Elizabeth Barrett

So great questions, you know as you know, we share the data from 102, as soon as we actually had the data available. So right now we're in the process of putting together our report that we need to send down to the agency prior to requesting a meeting, so that's happening right now. We expect that in the next week to be able to send our request down to the agency.

I think it's important to note a couple things. One, we actually met with the agency over a year ago before we started UGN-102 and the agency, the direction from the agency has been around that we can do a head-to-head study versus TURBT. To your point, it will be recurrence - free interval. So it is about time, it's not about CR rate that was always the discussion with the agency, and you know I know, I think there's been some misunderstanding about that but it would be recurrence-free timeframe.

So, you know time to recurrence. So we believe given that, and the high recurrence rate of the patients who have this intermediate risk that we have a very high probability of success of a superiority study, but we also will make sure that the study - becomes both a superiority and a non-inferiority that allow us two shots on goal to get an approval from the FDA. So, to answer your question, yes, we expect to go down, depends on when the agency gives us a meeting, but we expect it to be, the first half of the first quarter.

We are already - the protocol is close to being finalized, when we send it briefing documents down to the FDA we will have our proposed protocol, which will be a head-to-head study against TURBT with the endpoint being recurrence-free endpoint. So, we will enroll both - we will allow enrollment of both naive and recurrent patients. Just for your information about 80% of the patients in the 102 study were recurrent patient, but we did have about 20% patient’s naïve so we would allow that as well. So I think that captured all of your questions but if it didn't, please let me know. So thank you.


Our next question comes from Derek Archila from Stifel. Please go ahead.

Unidentified Analyst

This is Dan on for Derek. Thanks for taking my call. Just wondering if you can share some thoughts on what stood out to about 1884 and then was anything else looked at? Thanks.

Elizabeth Barrett

I didn't catch the first part, what about 1884 and I heard the second part was anything else considered, but what was the first question?

Unidentified Analyst

Yes, just - if you can share some thoughts about what - stood out to you about 1884?

Elizabeth Barrett

Yes, I think we spent a lot of time and we did look at many options and different types of partnership arrangements and different access, but we felt like the Agenus 1884 compound allowed us to own the CTLA-4 within our portfolio. And - that was something that we were very interested in. So being able to - manage and lead both the development and commercialization, actually own it in the space of our local delivery and uro-oncology we thought was really important.

A lot of due diligence, as you can imagine with the molecule and we feel very comfortable between our own internal team and external advisors we believe the molecule is a great molecule. We believe - long experience I think everybody does with CTLA-4. And I think we all understand that CTLA-4 is a great medicine for patients, but systemic delivery of it also has some side effects that has unfortunately caused either dose limiting toxicity, so patients or patients not able to take the medicine.

So we feel like, again our advisors that a local delivery of a CTLA-4 in this context is a great option for patients, and we believe we can get a good effect dose with CTLA-4 without some of the systemic side effects that you - typically see with CTLA-4. So sure we did diligence around across the board on everything that was out there. And came to the conclusion that it was a great fit for us, and I just want to comment that UroGen's team has been great to work with. We see them also as a good partner and we're excited to bring this - into our pipeline and into development for patients.


Our next question comes from Ram Selvaraju from H. C. Wainwright. Please go ahead.

Ram Selvaraju

So just wanted to clarify when you think you might get potential additional certification from CMS once UGN-101 has been approved in other words the timing of the assignation for example of J-code?

Elizabeth Barrett

So, typically what happens as you know with CMS, they used to do it just once a year and they've moved. They actually are officially trying to formalize quarterly review although we know that they have already actually done quarterly reviews on some medicines that have been approved. So, typically they would look at that once a quarter. So we would expect six months to be on the conservative side.

Frankly, that, we should be able to get a permanent J-code within six months. Having said that, I think it's also really important to note Jeff's also on the line, if you have any further questions about this, but that because of these procedures are done in the institution or in the surgery center. They are also eligible for a C-code, and we will be able to get a permanent C-code within the first three to six months. So we're basically conservatively saying that within six months, we would be able to have a permanent C-code and/or J-code - for UGN-101.

Ram Selvaraju

So this is just to clarify within three to six months of approval?

Elizabeth Barrett

Yes, correct.

Ram Selvaraju

And then with respect to the broader OLYMPUS study data set. Have you received any additional feedback from potential utilizing physicians regarding specifically the safety profile of UGN-101?

Elizabeth Barrett

Mark, do you want to comment on that?

Mark Schoenberg

No, actually what we received is more positive feedback that in fact, the AEs that were reported or expected in the context of treating this disease with contemporary technology. So what we've heard from doctors is that in fact this is exactly what they would expect and none of the adverse events reported would represent a barrier to utilization.

Ram Selvaraju

And then, with respect to the Agenus molecule and how you plan to deploy it going forward. I just wondered if you could give us some additional granularity on how you were thinking about deploying this checkpoint inhibitor in the context of urothelial cancer, beyond potentially combination with UGN-201. And also if you could comment on the relative positioning of your forays - into oncology, relative to the systemic administration of checkpoint inhibitors, like for example, the NIVO+IPI combinations in urothelial cancers? Thank you.

Elizabeth Barrett

Yes sure, Mark do you just want to talk about what our plans are initially with AGEN1884 and then we can talk more broadly about your question.

Mark Schoenberg

Sure, the first approach obviously and I think this is pretty well known from things that Liz has already announced, is to deal with the problem of high-grade non-muscle invasive disease, which represents a real conundrum for physicians, particularly those patients who recur or were demonstrate refractory behavior in the presence of BCG, which is the standard of care for this group. So, our first approach is to deal with that unmet medical need.

And so, we will be working on the combination we reported on our recent Investor Day. Because we have very strong reproducible preclinical information that suggest that the combination of 102 - excuse me 201 with 1884 like molecules in urine setting are very potent and actually prolonged survival in the model system. So that's our first attempt to advance this program.

Elizabeth Barrett

Yes. And I think beyond that, we actually don't have concrete plans about where we will take it, but we thought it was important to have the ability to - given the data with UGN-201 or TLR-7/8 agonist in combination with the CTLA-4, we think that there's potential applicability beyond high-grade non-muscle invasive bladder cancer. And to your question around the competitive landscape, this is a very different approach to anything that's out there today, right.

There are a lot of systemic PD-1 checkpoint inhibitor, studies happening in this space but we are the only ones that would be looking at this delivery mechanism for both TLR-7/8 in combination with CTLA-4. And just to be a little bit more finer on the plane, our plan is, is that we would use our RTGel, our proprietary technology with CTLA-4. And then the TLR-7/8 would be just an installation. So we have the ability to utilize our technology that no one else actually has access to.

So we think that this is a unique approach for the high-grade non-muscle invasive bladder cancer. And that we will have the R&D team looking beyond that. But that's where we have our data today. And we'll look to see if there are other applications outside of that.

Ram Selvaraju

And then just as a clarificatory point based on what you were just saying was, to what extent do you have a privileged intellectual property position with respect to the principle of localized delivery of an anti-CTLA-4 or checkpoint inhibitor as it were, whether in combination with a drug like UGN-201 or just directly.

Elizabeth Barrett

Yes. So our patent family is within our RTGel technology, so clearly the CTLA-4 in combination with our technology is something that we will continue to protect from a patent standpoint, and where we're able to continue to broaden that we will. But today, our patent protection is really on our RTGel and so it's 2031 to 2033. So we have a nice ability to protect that and going forward.


Our next question comes from Boris Peaker from Cowen. Please go ahead.

Boris Peaker

My first question is on the plan Phase 3 study of 102. I'm just curious, if we assume that will be using TURBT as a control which is kind of the current base case assumption. What do you anticipate the CR rate to be in that control on?

Elizabeth Barrett

Mark, would you like to talk about that.

Mark Schoenberg

Sure. As we've talked about before, this is a group of people have a very high rate of recurrence in a year and so we would expect based on published literature and also our internal experience that in the control group, the recurrence rate of the year would be somewhere between 50 and as high as 80%, so it's a group of people whom we would largely expect to recur, given their treatment with the standard of care.

Elizabeth Barrett

But I think - the question was really around but - is that your question Boris or was it really around initial CR.

Boris Peaker

Well, that's how I was going to say this initial CR and then there's the 12 months durability, so kind of want to - I want both.

Mark Schoenberg

Sorry, okay. Well, so as you - as it was mentioned earlier the focus of that trial will be on durability. But with respect to CR, I think it's important to step back and think about one other piece of information that doesn't get widely discussed in these conversations, which is that although Transurethral Resection is considered the gold standard for the primary treatment of this.

The CR rate is in fact not a 100%. So we would expect based on published literature with for example, augmented Transurethral Resection technology that this CR rate would probably be somewhere on the order of 80%. Because, we know that there is a stable recurrence rate, when white light cystoscopy is used during Transurethral Resection for the control group. So I think you need to think about that when you think about what the results would look like for the “experimental” or clinical trial group.

Elizabeth Barrett

Yes. I just want to know the focus on CR is not the focus right, it's not with UGN, I mean, it's important. The initial CR, but even with UGN-101, UGN-102, if you can't get the durability of response. So if you get, if you go in with a TURBT, even if it's 100% which we know it's not, we know it's closer to 80%.

If they're patient is back in three months. The initial CR is not very helpful, right? And so the reason that this patient population has such a high unmet need is because unfortunately they recur very quickly and very often. And, you know, we know from again as Mark said from the literature as well as the, you know, physicians that we've spoken to that everyone has those patients.

And this is an elderly patient and at some point, just you're doing more harm than good by continuing to have these repetitive TURBT. So the good news is, is that both the EAUA and AUA have come up with very specific guidelines as to who these patients are, so you can identify them up front, they're likely to recur.

But then again, as I mentioned before, the majority of our patients in our study were recurrent patients. So a patient comes in, they recover three to six months later, and - that is likely to be, the majority of our patients, which frankly is the biggest patient population, because that's the more the prevalent pool than the incident pool of this patient population.

Boris Peaker

And my last question is you've mentioned in the past a potential path forward with a single arm study designed for bladder cancer. Is that still a possibility, could you just comment on that?

Elizabeth Barrett

Well, I think that's the conversation we want to have with the agency, right and frankly, I think I probably did not do a good enough job, having everybody understand that we know from the agency already in our discussions that we can do a head-to-head versus TURBT. We can do that, we're writing the protocol, we're on - protocols almost I was finalized, again we're requesting a meeting with the FDA, we feel very strongly there won't be any issues with that.

The question that we had is given the results are much stronger than we expected them to be and we'll see how that plays out over the next few months. If they maintain - if we have a good durability then we would want to talk to the agency to see if there's a faster path to making this available to patients, whether it's a single arm study with a control real-world evidence study, or whatever it might be, but we would want to do that.

But we're not going to delay the start of our head-to-head study. But we do want to have that conversation with the agency. You never know, we think that the likelihood based on the conversation we've had with them in the past, they want to see a head-to-head study.

I think that they also don't really understand we need to educate them around this intermediate risk patient, which is the patient that has a high, high probability of recurrence and likely recurs within a few months. So, we want to have that conversation with them. So, is there an opportunity? Sure there is. But what do we know that we can do as a head-to-head study with TURBT and that's where we've moving forward with.


Our next question comes from Leland Gershell from Oppenheimer. Please go ahead.

Leland Gershell

Thanks for taking my question. Also a couple of questions on - one or two, I guess for Mark. If you could tell us what you may think the required sample size might be for the head-to-head study in terms of number of patients needs to be adequately powered for that endpoint? And also, if you may have any further clarity on when we might see the next reveal on the current OPTIMA study? Then I have a follow-up. Thanks.

Mark Schoenberg

So, I think the answer to the first question is we're still working on it and I think Liz is really emphasize the fact that we're coming down the final stretch of working on that protocol. Obviously, trying to balance non-inferiority and superiority trial designs as they impact power. So, we know that this is going to be a trial that is going to involve hundreds of patients, the question is specifically how many and we're working on that now and I think we'll have more clarity on that once we've had our opportunity to finalize the design and then talk to the agency. That's probably about as much as I can say.

And then in terms of the additional information about OPTIMA II, I think I have to defer to Liz on timing, but we are advancing that program and we know that we're going to have a lot more data on the durability of that cohort in the first half of 2020.

Elizabeth Barrett

Yes, I mean I think what we'll do is we'll see how the data plays out and when we feel like we have enough data that it's meaningful, we'll share that data. So, we won't be shy about sharing it but we want to make sure that when we do, we have enough to make it relevant.

Leland Gershell

And then one question on 101 as we the toward commercial next year in addition to modeling expense for selling in terms of salesforce infrastructure, I also wanted to hear any commentary you may have about other expenses that may relate to logistics, given the nature of the product, mixing requirements, and so forth. Thanks.

Elizabeth Barrett

Yes, I'll just answer. I know Jeff's on the line, but since you're really specifically asking about expenses and then Peter can comment if he has any other questions. We do have obviously expenses within our supply chain right. So as we talk about before a very key strategy for us is ensuring the ease of use which means that it will - the our supply chain will require us to go to a specialty distributor, and then to a mixing partner which is fairly typical for this - these types of products.

And so all of those would be included in our cost of goods and so, you know we are looking at to have that. So it's a big part of our strategy. I wouldn't say, it's like overly expensive, it's very reasonably priced to be able to do it, makes a lot of sense. Because, again, we think that key to early adoption and quick adoption will be making it as easy as possible on the positions.


Our next question comes from Chris Howerton from Jefferies. Please go ahead.

Unidentified Analyst

This is [Syed] in for Chris. The first question that I had was really a clarifying one on your comments for the one or two pivotal. Did you say that you were trying to make it both a non-inferior and superiority study and if so, could you please comment on how that would work, start there?

Elizabeth Barrett

So, yes, what I would - I did say that, I did say that we would want the ability to be able to have, both a superiority and a non-inferiority standpoint, if you employing - I'm sorry if you, and this has happened, many, many times in the past. But it's basically, when you look at it and when you do - review of the day, then and if the data is, you know, this is a time bound as we talked a lot about.

So the longer that you follow these patients, the more likely we are to be superior. And in our case and - but you can get to a point where, if you want to look at, similar recurrent free rates, you could potentially have a claim of non-inferiority.

So it's easy to design a study, they've been done many times where you have both a superiority and then are able to follow for non-inferiority. So likely you would have “a non-inferiority earlier, and a superiority later” but we just we want to make sure again that we cover all of our bases.

Having said that, we feel pretty strongly that we're going to get to have a superiority right we've seen the data we share with you the data, the durability, looks good and if that holds up, then you know we think that is a very high likelihood that will have a superiority study.

Again, I guess another point just to add on that is, if you have non inferiority from an advocacy standpoint, clearly a management and the color associated with that actually having multiple TURBT is another area in which we believe that we will have a benefit versus current standard of care. So I hope that's helpful.

Unidentified Analyst

Yes, that's very helpful. But you know, the one remaining question I have as it relates to that is that, if you are open to the possibility of both, does that mean that you are trying to enroll for the non-inferiority, so I guess what I'm saying is are you trying to enroll the larger patient population versus what you would need to for superiority - for superiority trial?

Elizabeth Barrett

We haven't seen that data, the numbers yet, so we'll have to make that decision. As I said, the team is finalizing the protocol. We're working with a couple of external statisticians that will make sure that we understand exactly what you know, what we need. So that will - it will be dependent on the number of patients to your point.

Unidentified Analyst

And the last question that I had was on the 101 commercialization. Thanks for providing all the color earlier, but I kind of wanted to know, what were the remaining steps to get prepared for this commercial launch. You said you're going to be prepared by very early next year, so I'm curious to know what the last remaining steps are?

Elizabeth Barrett

Sure, absolutely. And we have Jeff Bova, he's on the line. He's our Head of Commercial. So Jeff, can you take that question, please.

Jeff Bova

Sure. So, as Liz alluded to earlier, we will have the field force hired by early mid-January, so that the step. Once we bring them on board, they'll go through training, background on the disease. Once we have a label will be a final training with regards to the label, while they're - when they're brought on they'll also do some account profiling, so they'll call on the various accounts understand the logistics how things work, so we're able to if approved immediately begin to promote the product into the practice and as another option for patients.

We also, as right now, from a marketing standpoint, we're finalizing our messaging campaign. We're getting, you know we're getting pieces ready for journal ads that if approved will say, you know, not now approved everything will be in place.

From a market access standpoint, we've already chosen the hub. Our hub will be how the customer provided order the product. So the hub is already chosen as well as our PPL and our specialty distributor. So those, those are all in place now. And once, as we move closer to launch, will be able to accept, like I said, if it wasn't approved, be able to take an order through the hub and get it into or get it to the provider.


Thank you. I am showing no further questions at this time. I will now turn the call back over to UroGen’s President and CEO, Liz Barrett for closing remarks.

Elizabeth Barrett

So thank you operator, and thanks everybody for the questions. I think it's a very exciting time. As you've heard this morning and then our announcement yesterday, I think with the addition of the CTLA-4 Agenus 1884 trial pipeline, you can see that we're really covering the gamut of uro-oncology. We've got UGN-101. Now we have filed. Expectation is to launch mid-year next year UGN-102, which will go into a pivotal study next year and then now with the addition will be - it will begin to advance UGN-201 or a tail or seven, eight agonist in combination with local delivery of CTLA-4 and high-grade disease.

So an exciting time for us and that'd be a nice complimentary pipeline to move forward. So again we couldn't be more excited as we grow our position as a leader in uro-oncology and build value for both our shareholders and importantly bring new innovative unique treatments to options to these patients in areas of high unmet needs.

So we'll continue to update you as milestones come through for the remainder of this year and into next year and we thank you for joining our call and your continued interest in UroGen. You can disconnect now operator. Thanks, everyone.


Thank you, ladies and gentlemen. You may now disconnect.

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