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UroGen Pharma Ltd. (URGN -1.97%)
Q2Â 2019 Earnings Call
Aug 12, 2019, 8:30 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good morning, ladies and gentlemen. Thank you for standing by, and welcome to UroGen Pharma's Second 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.
Kate Bechtold -- Senior Director of Investor Relations
Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's second quarter 2019 financial results and business update conference call. On Friday morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended June 30th, 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 updates. Peter will then provide an overview of our financial highlights for the second 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 provisions 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 on August 9th and other filings that UroGen Pharma makes with the SEC from time to time. We encourage all investors to read the Company's annual report on Form 10-K and the Company's other SEC filings. These documents are available under the SEC filing 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.
Liz Barrett -- President and Chief Executive Officer
Thank you, Kate, and good morning, everyone. We hope you are enjoying this summer and appreciate you taking the time to join our call this morning. Before, we get into the heart of the quarterly call, we're thrilled to announce that on Tuesday, September 24th, we will host our first Investor Day.
The first half of 2019 has set the stage for what is certain to be a pivotal year for UroGen, as we approach key milestones over the next few months. During the event on September 24th, we will provide long anticipated updates on key events, including top line of the final data set for UGN-101 for the treatment of patients with low-grade upper tract urothelial cancer. We will also share the initial complete response data for UGN-102, our investigational program for low-grade nonmuscle-invasive bladder cancer, as well as pre-clinical data for UGN-201, the investigational formulation of our TLR7 agonist.
We will outline our long-term strategy and plans for advancing our portfolio. In addition to updates from management, we will have a panel of urologists with experience using our medicines. They will provide a real-world perspective on how they see our treatments fitting into their practice. We hope you will be able to join us for this exciting event.
For today's call, I am pleased to share that we have submitted the CMC modules of our rolling submission for the new drug application for UGN-101 to the US Food and Drug Administration. We've locked the database on our Phase 3 OLYMPUS study and remain on track to complete the submission and prepare for planned acceptance in the fourth quarter of this year. As many of you will recall, UGN-101 has been granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations by the FDA.
As such, following the anticipated completion of our rolling NDA submission, we expect a six-month PDUFA date, which sets us up for potential US approval and launch for UGN-101 by June of 2020. We are incredibly excited about the potential of this program to transform the treatment paradigm for patients with low-grade UTUC. Low-grade UTUC remains an area of high unmet medical need. If approved, UGN-101 would be the first approved therapy for this patient population, which we believe represents around 6,000 to 7,000 patients.
Today, these patients are treated with surgical intervention, which puts them at risk for the well-known complications associated with repetitive endoscopic and potential kidney removal. Based on the literature, approximately 80% of these patients would ultimately undergo kidney removal. We believe, if approved, UGN-101 can provide patients with a treatment option that avoids the risk and downstream sequela associated with surgery. We are continuing to ramp up our pre-commercial preparation activities and build out. Our commercial strategy will ensure a comprehensive understanding of the high unmet need in these patients, will build awareness of RTGel technology of our Company UroGen and our mission to provide meaningful advances to patients with the urological and oncology conditions. The commercial team is building innovative solutions for physicians and payers to ensure rapid and broad adoption at launch.
UroGen is poised to be the primary resource for all stakeholders in the area of low grade UTUC, a disease that has previously been ignored. It is also critical that UGN-101 fits seamlessly into the urology practice. Our market research indicates that 88% of physicians would like to have a treatment that delays or prevent radical surgery interventions for these patients. We understand the current treatment paradigm and the needs of the physicians, practices and patients.
In addition to our field representatives, we will have a small team of nurse educators to provide training and support around installation. We have hired most of the sales management team and they will begin recruitment for a 50-person sales team to efficiently reach our target urology accounts. Given that 33% of urology practices treat 90% [Phonetic] of the UTUC patient population, we are confident that a lean team of 50 will be able to effectively navigate the unique needs of UGN-101 across these practices.
In addition, given the complexity and importance of reimbursement, we will hire a small team of field reimbursement specialists. Our multi-disciplinary team will be staffed and trained by year-end, so that we will hit the ground running upon potential US approval and launch in the first half of 2020. In addition to our specialized team, we have support programs and distribution reimbursement and pharmacy. Our commercial team has extensive experience in uro-oncology. It is currently finalizing our launch plan to support rapid adoption.
We will be prepared for a successful launch and look forward to bringing UGN-101 to patients in the first half of 2020. In parallel to our commercial preparation activities, we continue to advance our pipeline programs, including UGN-102 for low-grade non-muscle invasive bladder cancer. Patients with low-grade non-muscle invasive bladder cancer have very limited treatment options, as there are currently no drugs approved by the FDA as first line treatment. We believe that UGN-102 has the potential to replace the current standard of care, which is repetitive surgical resection via Transurethral Resection of Bladder Tumor or TURBT for up to 80,000 patients a year. We look forward to sharing early complete response data on a cohort of patients from the Phase 2 OPTIMA II trial of UGN-102 on the 24th of September at our Investor Day. Beyond our internal pipeline programs, we continue to evaluate business development opportunities to maximize the potential of our RTGel technology in both oncology and urology.
We currently have an early stage feasibility agreement with Janssen in a therapeutic area of mutual interest, as well as a collaboration with Allergan, an overactive bladder. Lastly, I'm excited to share that Dr. Robert Uzzo has joined UroGen as a special advisor, and will be working closely with our medical affairs team. Rob is a well-known and well-respected leader in the field of urological oncology and has made important scientific and clinical contributions to the field. Rob brings a unique experience and joins a team of accomplished leaders united in the desire to transform the field of uro-oncology.
I'd now like to turn the call over to Mark, who will discuss our clinical development programs and progress in more detail. Mark?
Mark P. Schoenberg -- Chief Medical Officer
Thank you, Liz. We have been very encouraged by the progress we've made in the clinical development front and look forward to the exciting events on the horizon. To provide a brief recap of the results from the OLYMPUS trial for UGN-101, the analysis presented at the AUA showed that in the intent-to-treat population, 71 patients had undergone primary endpoint evaluation at the time of the analysis, and 42 of the 71 patients or 59% achieved a complete response. 41 patients entered follow-up. Of the evaluated complete responses to date, 27 patients have undergone a six-month evaluation, and 24 of the 27 patients, or 89%, have remained disease free at six months.
Overall, five of 41 patients who achieved a complete response have relapsed at any time during the study. Of these 71 patients, 34 were initially characterized by the treating physician as having endoscopically unresectable tumor at baseline, and 20 of 34 of these patients, 59%, achieved an initial complete response. These are the patients who, under the current standard of care, would be candidates for immediate kidney removal. The most common treatment-emergent adverse events were ureteral stenosis, urinary tract infection, hematuria, flank pain, nausea and dysuria. The most treatment-emergent adverse events were characterized as mild or moderate and transient.
Based on the data, we remain encouraged by UGN-101's potential to change the treatment paradigm for low-grade UTUC and to address a significant unmet need. UGN-101 presents physicians and patients with an opportunity to chemoablate and potentially preserve the kidney or delay kidney removal. The technology, procedures and protocols involved in UGN-101 installation are very standard to urology practices. As a practicing urologist, I can personally attest to the clinical challenges that physicians face when treating low-grade UTUC. And we are confident that if approved, UGN-101 will provide urologists with an organ-sparing treatment option that aligns well with standard urology and ambulatory practice.
As Liz mentioned, we look forward to presenting final data from the OLYMPUS Trial at our Investor Day on September 24th. We've also received questions and interest around the possibility of retreating patients who relapsed following treatment with UGN-101. To that end, we have launched a retreatment study as an extension of the OLYMPUS trial, and look forward to providing updates in the future.
In addition to UGN-101, we are making excellent progress in developing our UGN-102 program. We anticipate completion of enrollment of our Phase 2b OPTIMA II clinical trial of UGN-102 ahead of schedule. As a reminder, this trial is a single-arm open-label multi-center trial designed to assess the efficacy and safety of UGN-102 for intravesical instillation as a potential first-line chemoablation agent in the treatment of patients with intermediate risk low-grade non-muscle invasive bladder cancer. Non-muscle invasive bladder cancer is similar to UTUC in the sense that the patient population is broken down into two groups, those with high-grade and those with low-grade disease. And we are again focusing on the low-grade disease.
Within the low-grade patient population, we are studying a population referred to as intermediate risk. The definition of intermediate risk includes patients with multi-focal disease, large tumors and rapid rates of recurrence. This is a patient population whereby the current standard of care Transurethral Resection of Bladder Tumor or TURBT is used repeatedly to address chronic recurrence of disease. These patients experience what can be viewed as a form of surgical failure, and many undergo multiple surgical procedures during their lives to manage bladder cancer recurrences. We believe UGN-102 can have an immediate impact and provide this patient population of approximately 80,000 with a first-line non-surgical option for the treatment of chronic relapse.
As Liz already mentioned, we look forward to providing a data update on this program at our upcoming Investor Day. The initial data update will consist of complete response rate with durability information to be reported at a later time.
We also continue to advance our UGN-201 program, our TLR7/8 immunomodulatory agent for the treatment of high-grade bladder cancer. Phase 1b study of UGN-201 in carcinoma in situ, or CIS has suggested a preliminary advocacy signal, while pre-clinical models have demonstrated anti-tumor effects for high-grade disease. We are exploring the utility of UGN-201 in the context of novel combinatorial immunotherapy for non-muscle invasive bladder cancer and look forward to providing you with updates at our Investor Day.
And with that, I would like to turn the call over to Peter, who will discuss financials.
Peter P. Pfreundschuh -- Chief Financial Officer
Thank you, Mark, and good morning to everyone on today's call. UroGen is well capitalized to further advance our clinical development programs as well as our commercial planning efforts in preparation for a potential US approval and launch of UGN-101 in 2020.
We closed the second quarter of 2019 with $233.3 million in cash, cash equivalents and marketable securities. For the second quarter and six months ended June 30th, 2019, we reported a net loss of $22.5 million, or $1.08 per share and $43.9 million or $2.19 per share, respectively. This compares to a net loss of approximately $18 million, or $1.14 per share and $31.4 million or $2.02 per share for the same periods in 2018. The net losses for the second quarter and six months ended June 30th, 2019 includes $7.2 million and $14.7 million respectively in non-cash stock based compensation expense.
Research and development expenses for the quarter and six months ended June 30th, 2019 were $10 million and $19.7 million respectively, compared to $8.3 million and $15.9 million for the same periods ended June 30th, 2018, and included $2 million and $4.3 million in non-cash stock-based compensation expense respectively. The increase from 2018 to 2019 was attributable mainly to costs associated with UGN-101 Phase 3 OLYMPUS trial and the increase in personnel costs to support our ongoing clinical and regulatory efforts, and an increase in share based compensation expense.
General and administrative expenses for the second quarter and six months ended June 30th, 2019 were $13.8 million and $26.5 million respectively, as compared to $10.2 million and $16.3 million for the same periods in 2018 and includes $5.2 million and $10.3 million in non-cash stock based compensation expenses respectively. The increase from 2018 to 2019 was mainly attributable to an increase in personnel and related costs to support our growth in the business and an increase in commercialization, infrastructure and services, an increase in consulting and other outside fees and an increase in share-based compensation expense.
As of June 30th, 2019, we had approximately 20.8 million ordinary shares outstanding. As you have seen from both our Q1 and Q2 earnings releases, the Company continues to achieve its 2019 financial guidance as set forth in February of this year. Based upon our anticipated activities and business goals, we still plan to have a net loss of approximately $100 million to $115 million, which translates into a cash burn of approximately $76 million to $88 million for calendar year 2019. We still project our current cash balance to carry us for at least the next two years.
With that operator, I would like to turn the call over for questions.
Questions and Answers:
Operator
Thank you. We will now begin the question-and-answer session. [Operator Instructions] And our first question comes from Derek Archila from Stifel. Please go ahead.
Benjamin Burnett -- Stifel -- Analyst
Great. Thanks, guys. This is actually Ben on the line for Derek. Just wanted to ask what type of feedbacks you guys you're hearing docs [Phonetic] from right now. Thanks.
Liz Barrett -- President and Chief Executive Officer
Hi, Derek. Good to hear from you. It's Liz, and then I'll turn it over to Mark and he can also add some commentary. We've been doing obviously a few things with physicians in the market. One, we've been doing our own kind of market research out in the field and the good news is the market research is coming back that about 88% of physicians are interested in -- highly interested in an alternative to kidney removal. So we think that there's a really high unmet need out there. As we've mentioned before, if you think about the number of physicians that were in, have experienced with our UGN-101 and UGN-102, it's a very small portion. So one of the priorities we have for 2019 was around building awareness. We had a great AUA, which we talked about at our last call and our [Indecipherable] are out in the field, and we're getting very positive feedback and reason out, why, Mark, to sort of also comment is that he has also had a few calls from physicians with patients, looking to be able to use it with patients ahead of the approval. So, we've got -- we are getting, I think, more awareness of the -- of our treatment and also a lot of interest. And Mark, can you just comment?
Mark P. Schoenberg -- Chief Medical Officer
Yeah. And just to underscore what Liz was saying, we are continuing to hear from physicians in the community as well as our academic partners and KOLs that there is interest in knowing when the drug will actually be available because they are patients that they are lining up for treatment. And now this is part of their thinking in terms of planning therapy for individuals who have low-grade disease. So, we know that the efforts to socialize the availability of this and the potential of this therapy is beginning to work within the community. So, there is interest and we continue to hear this. And we just actually had a KOL investor -- excuse me, scientific advisory meeting in Washington this weekend and continue to hear this from interested physicians. So I would say there is a high level of interest.
Benjamin Burnett -- Stifel -- Analyst
Great. Thanks for the info, guys.
Liz Barrett -- President and Chief Executive Officer
Thanks, Derek.
Operator
Our next question comes from Eric Joseph from JPMorgan. Please go ahead.
Turner Kufe -- JPMorgan -- Analyst
Hey, good morning, everyone. This is Turner on for Eric. I'm just curious how you're thinking for UGN-101, how are you thinking about outside US commercialization, perhaps, in terms of partnerships? And do you have any EU regulatory feedback and what steps would need to be performed before filing with the EMA? Thanks.
Liz Barrett -- President and Chief Executive Officer
Sure. Turner, it's a great question and one that we've been looking at and actually just started to work with some consultants on moving that forward, outside the US. To be honest with you, we don't think it's much of a regulatory hurdle in the US as it is -- I mean in the EU as it is a reimbursement hurdle. So what we really need to do is we need to -- we have had initial discussions with the regulators. As you know, Europe is usually a lot more difficult to get an approval on an open-label single-arm study. But they also recognize the high unmet need and have been open to a regulatory approval based on our current UGN-101 study. Like I said, the bigger challenge, though, if you think about how reimbursement occurs in a lot of the countries in the EU is they want comparators, right? So they put it in the basket of compares, that's how they price you. And right now, without head-to-head data, they are likely to want a price at the generic level, which obviously doesn't make sense for us or our partner. So one of the things that we're doing as a next step is gathering some additional information on what type of study would they need to see. And it would likely be a superiority study, which we believe we could do and to be able to get a reasonable reimbursement. So, we -- really to be honest, we've been focused on getting the NDA in the US, getting the launch in the US, and then thinking about outside the US.
The other market that I would just want to highlight for a moment, because we've been doing some intelligence work around is Japan. As you may or may not know, the Asia population has a higher incidence of UTUC. And I mean, in a market like Japan, obviously, you can get a fairly reasonable reimbursement and we would need to do a bridging study. So what we have right now is someone working on getting some -- a meeting set with the regulatory agency in Japan where we'll do further work on what it looks like.
We have had other parties, to be honest with you, interested in partnering on certain geographies. But what we don't want to do at this point, we think it's in our best interest and our shareholders' best interest to maintain our freedom to operate and not license out in individual markets. So I think what we'll do is continue to move that ball forward. Now that we're getting closer to the US submission, and we can have some time to be able to address those markets. And then, but, your likelihood is that we would probably look to partner outside of the US.
Turner Kufe -- JPMorgan -- Analyst
Got it. Thank you. That's helpful. And then for UGN-101 life cycle management, there's a study up on ClinicalTrials.gov for 101 retreatment, I'm hoping you just discussed the trial a little bit and what would be viewed as a meaningful, complete response rate in this population. And then just a follow-up to that, do you have any additional plans to conduct further studies for expanded use perhaps, as an adjuvant surgery, for instance? Thank you.
Liz Barrett -- President and Chief Executive Officer
So, I mean, I think, look, we're open to looking at life cycle management across 101. So, absolutely interested in that. And Mark did mention during his remarks in the beginning about the retreatment study and that there's something that we put in place because we do believe and actually have already heard a lot from physicians their plan to retreat, right? So as long as they get a good response the first time and with our high CR rate that we've disclosed with a high CR rate, physicians are interested in retreatment. And which is why I said, Mark can talk to you more about the study specifics, but it's really an extension of our current study. So as these patients recur, which the good news is, is they're not recurring at a high level. We do expect physicians to be interested in and wanting to retreat. And we think it's an important piece of data for them to have as well as hopefully included in our label for -- and for reimbursement. So we're moving forward with that. I don't know, Mark, if you want to add anything else to that?
Mark P. Schoenberg -- Chief Medical Officer
The only thing that I think I would add is, that we have some confidence that retreatment would make scientific and medical sense because there is a predicate practice in urology using mitomycin repetitively in responders who have not invasive bladder cancer. So the notion and the scientific basis for doing this in the kidney with 101 makes sense to us and make sense to our colleagues in practice. And as was pointed out, I think we will see physicians retreating patients and we obviously are interested in seeing the data as our experience matures in that area as well.
Turner Kufe -- JPMorgan -- Analyst
Great. Thanks so much.
Liz Barrett -- President and Chief Executive Officer
Thank you. Next question.
Operator
And our next question comes from Paul Choi from Goldman Sachs. Please go ahead.
Paul Choi -- Goldman Sachs -- Analyst
Hi. Good morning, everyone, and thanks for taking our questions. Maybe one for Mark to start just with regard to the OLYMPUS update that you'll have at your Investor Day. Can you maybe just confirm for us that all the patients that didn't -- weren't included in the six-month follow-up at AUA data will be included at the six-month? Will have follow-up there. And then second, for the patients, you did have at AUA, can you just maybe confirm for us that what the median follow-up will be for that population?
Mark P. Schoenberg -- Chief Medical Officer
So the answer to the first question is we're going to tell you that everybody we've got in locked database at our Investor Day. So we'll -- we're going to give you what we think is the bottom line story on this trial. So I hope that sufficiently informative to gives you confidence that you're going to have a lot of information about this trial at that presentation. And I'm sorry, I'm not sure I understood the second question?
Paul Choi -- Goldman Sachs -- Analyst
For the patients who were included in the six-month follow-up at AUA, I was just wondering, can you maybe confirm for us what the median follow-up roughly will be for those patients?
Mark P. Schoenberg -- Chief Medical Officer
The median follow-up for those who were not presented?
Paul Choi -- Goldman Sachs -- Analyst
For those who were included in the AUA presentation?
Mark P. Schoenberg -- Chief Medical Officer
Yeah. I can't give that to you right now, but we will certainly present -- we will present a full picture of our six-month follow-up data, which will be more than was presented at the AUA.
Liz Barrett -- President and Chief Executive Officer
So, Paul, do I -- it's Liz. Are you asking for the follow-up beyond six months in [Phonetic] what will be shared?
Paul Choi -- Goldman Sachs -- Analyst
That's correct. Right. Not all patients were included in the six-month follow-up at AUA, so I was just curious for the ones that were included. What the median follow-up would be for them?
Liz Barrett -- President and Chief Executive Officer
Right. So just a couple of points on that. One, as Mark stated, we locked the 101 database, but that does not mean that we will have 100% of patients in follow-up. As we've communicated earlier, our discussion with the FDA is that they wanted to see at least 75% of the patients. We will not have a CR in 100% of patients, and we won't for our submission, we've been very transparent about that along in conversations with the FDA because we didn't want -- that would have put us into 2020 with a submission. So, we will, as Mark said, we've locked the database. This will -- the data you'll see on the 24th will be the full data set that we will share with the FDA.
Now, what we have not disclosed and likely will not, is on patients, all that -- all of the data beyond that and mostly because of publication. And we want to make sure we maintain the integrity of the data, so that we can -- because well, that our next step will be and we've already begun to work with the investigators is to ensure that we have a publication prior to launch. So, some of that data will be maintain confidentiality until we get our publication.
Paul Choi -- Goldman Sachs -- Analyst
Got it. Thanks for that. And then on 102, we're looking forward to seeing the initial cohort you described at your Investor Day as well. But just in terms of progressing with next steps, do you feel that the data you have in hand is enough to inform sort of next steps either with the regulators, or do you want to see data first from the additional patients?
Liz Barrett -- President and Chief Executive Officer
No, I think that, one of the reasons that we picked September 24th was that we knew that we would have enough of data for 102 that we would have a really, really great signal as to whether it works or doesn't work in this patient population. The team together and thinking about the timing of taking an interim look, we were really close to having about 50% of the patients. So it was important, by the time we get to the September 24th, they will actually have the initial CR data on almost half of the patient population. And so, because we have -- we will have the data on half of the patient population, depending on the results, if they're positive, our plan is to immediately move to a meeting with the FDA to understand exactly what they would need and want to see for a pivotal study.
And we want to move forward and accelerate that as quickly as possible. And so, the plan at this point is as soon as we have the data and look at the data, review it, is to move forward and not to wait to -- because we think that with half of the patients, we think that would be a good projection for what we would see in the final -- with the final data. The piece we won't have and when we talk to the agency, which will be important, but it will give us some level of confidence with the data that we do have is the durability, right, and the duration of response. But once we see the current database, I think we'll -- we believe that we'll have enough data to be able to have a meaningful conversation with the agency on what they would want to see because we want to accelerate that and start that study as quickly as possible.
Paul Choi -- Goldman Sachs -- Analyst
Okay. Thanks for that. Just then, turning to your recently announced collaboration with Janssen, can you maybe just frame for us, what's involved with regard to the clinical development and sort of help us book and what sort of bio bucks might ultimately be involved with the deal? Thanks for taking our questions.
Liz Barrett -- President and Chief Executive Officer
So, look, we've been very clear that we have a limited amount of data that we can actually share. And what we've said is that, it's a formulation feasibility study. So the important thing about our proprietary RTGel is that we knew every time that we develop the gel with an agent, whether it's -- the mitomycin that we have today are with other novel agents, taking BOTOX for it as an example, we actually have to customize the formulation.
And so, while we believe that there is not an issue to be able to put any novel therapy into our gel, that's something that we obviously have to figure out. So what we're doing with our announcement is we're making sure that we can take the innovative medicine that we have with Janssen and move forward with a formulation. So that's the work that's ongoing right now, is a formulation feasibility. Once that data, assuming that it's positive and we're able to develop a new therapy with our RTGel and their novel medicine, then we would have discussions around how we take that forward and what the clinical development plan looks like and what a partnership may or may not a collaboration may or may not look like. So we have not gotten to that point. We've been very clear that what we have right now is a feasibility study. So I hope that's helpful.
Paul Choi -- Goldman Sachs -- Analyst
It is. Thank you very much for taking our questions.
Liz Barrett -- President and Chief Executive Officer
Thank you.
Operator
And our next question comes from Boris Peaker from Cowen. Please go ahead.
Boris Peaker -- Cowen -- Analyst
Great. Thanks for taking my questions. My first one is on the just the low-grade UTUC. Can you comment, what fraction of patients could be resected versus the ones that can't be?
Liz Barrett -- President and Chief Executive Officer
So I'll let Mark talk about the patients.
Mark P. Schoenberg -- Chief Medical Officer
Boris, let me just make sure I'm going to answer your question. Are you talking about within the trial, or are you talking sort of generally within the population for which...
Boris Peaker -- Cowen -- Analyst
Generally within the population.
Mark P. Schoenberg -- Chief Medical Officer
Yeah. So if the trial is any reflection of the general population, which we believe it is, then we think based on what our surgeons have told us in the trial, that somewhere -- around 50% of patients are amenable to an endoscopy resection and 50% actually or not. 50% of the participants in this trial were just about 50% had tumors that were characterized by the investigators as technically unreachable by laser fiber. So therefore, would not have been amenable to endoscopic resection.
Boris Peaker -- Cowen -- Analyst
And so just --- if we divide the world into those two groups of resectable, and non-resectable, do you see one particular -- one of them kind of lower hanging fruit for the drug when you launch it, or is the need or an adoption you anticipate to be similar in both of those?
Liz Barrett -- President and Chief Executive Officer
And I think the important data that we shared at AUA around the non-resectable and the resectable was that regardless of whether it's resectable or non-resectable, the data was very similar. And that was an important finding for us. So, we don't see, frankly, a difference between the resectable or non-resectable population as far as physicians desire to use the medicine. And so, we expect that we will be able to use it and gain adoption in both of those patient populations.
I think the other thing to mention, as Mark said, you have to keep in mind that around 80% of the patients -- 78% of patients will eventually get a kidney removal. So -- and physicians know this, they are aware of this. The patients that do get endoscopic resection in the beginning tend to come back again and again for repetitive endoscopic resection before they finally move to a kidney removal. And so, with this in mind, we don't see why physicians wouldn't want to use this in all of their patient populations because they again know that eventually these patients usually end up in kidney removal. So we see that as being an opportunity for all of the patient population.
Boris Peaker -- Cowen -- Analyst
Great. And my last question is on the clinical development side. If we think about the bladder strategy there, can you comment just around the Phase 3 specifically? Would you have to run it against UTUC and would you need to look at superiority versus non-inferiority be adequate as an endpoint? And just kind of ballpark, how long would a study like this take?
Liz Barrett -- President and Chief Executive Officer
Yeah. So, actually the team has been working on developing the what a Phase 3 might look like is frankly at this point is a simulation. It's like if the agency accepts this, we believe that they would take a non-inferiority. The question is, would you want to do with a non-inferiority or superiority study. And it really depends on what the agents have to say. I think one of the things that we've been focused on with 102 is and moving forward with a potential Phase 3, assuming the data is positive, is really a gathering in one of the things that Mark and his team are working on right now is gathering data around this intermediate risk patient population. I don't believe that there's a true appreciation by the FDA and the regulatory bodies at this point about this particular patient population. As Mark has mentioned, we've talked many times, this is a patient -- again, a patient population that ends up with these repetitive surgeries. And they're just -- they're just not -- their needs are not met by today's standard of care.
So this is a patient population that we want to have more of a dialogue with the FDA to one, share the data, some data that we're currently generating around that patient population and the high unmet need in that patient population. And we believe that the agency has really understands that -- I think that they will be more flexible. At least, we hope that they'll be more flexible around what a Phase 3 pivotal study might look like. But that would be one piece of data that we would want to generate.
And so, I think we're prepared and we've got like I said, different scenarios of whether we have to do an non-inferiority or superiority study, we feel very confident that, if the data is met -- we have to wait to see, but if the data is similar to what we see in our 101 for the UTUC, but I think the important thing for us is to really sit down with the FDA and have a discussion around what that pivotal study would look like.
So we don't have timing because clearly, as you know, it depends on the number of patients that would be in that study and that really depends on what the FDA wants to see. I think one thing I will tell you is we are ahead of our enrollment in the 102 study and which is the reason that we will be able to share 50% of the patients. I think when we initially started talking, we had -- we were hoping we'd have 25% to 30% of that patients to be able to share in our first publication of the initial data, instead, we're going to have 50% of the patient population. So I think that shows you that there's an interest -- a high interest among investigators. So, we believe that we'll be able to hopefully accelerating and quickly enroll any [Phonetic] pivotal study that we need to do for 102.
Boris Peaker -- Cowen -- Analyst
Great. Thank you for taking my questions.
Liz Barrett -- President and Chief Executive Officer
Thank you.
Operator
Our next question comes from Ram Selvaraju from H.C. Wainwright. Please go ahead.
Raghuram Selvaraju -- H.C. Wainwright -- Analyst
Thanks very much for taking my questions. So, I wanted to drill down on whether you see any evidence that the 12-month follow-up data is specific to the low-grade UTUC indication would be necessary or potentially awaited by physicians in order to have them fully change their treatment practices in this indication.
Liz Barrett -- President and Chief Executive Officer
Yeah. I'll just make a comment and turn it over to Mark, and he can add any additional color. The reason that we are filing with the six-month data is this is the average -- current average time to recur. So patients, average time that recur today is six months, so we believe that, that's the most meaningful. And that's the conversation we've had with the agency.
Of course, I think everybody would be interested in the 12-month data, but we don't think that, that data is necessary for adoption, although I'm sure physicians would be interested in. And Mark, I don't know if you want to add anything.
Mark P. Schoenberg -- Chief Medical Officer
I agree. That's the answer.
Raghuram Selvaraju -- H.C. Wainwright -- Analyst
Okay. Fantastic. I also wanted to ask about whether you could just give us a brief overview of the billing process that you envisage for UGN-101, and the potential relevance of the faster J-code assignations that we've been seeing on multiple other fronts from CMS?
Liz Barrett -- President and Chief Executive Officer
Yes. I'm really thrilled that we have Jeff Bova on the line, and he's our Head of Commercial. And the team has been working diligently on the issue of reimbursement because we do believe that will be a key success factor for us. So I'm just going to turn it over and let Jeff answer your question. Jeff?
Jeffrey Bova -- Senior Vice President of Commercial
Sure. Thanks, Ram, for the question. Yes, from a billing standpoint, the physicians that either own or are affiliated with their own surgery center will bill for three components, the professional fee, which is the fee that the physician actually gets; the technical fee, which will be the fee that the office of the surgery center would get; and then because we are a Part B, as in boy, drug, we will have a buy-and-bill model, where they will be reimbursed on the drug as well.
With regards to the J-code application, we will go through the traditional application timelines, depending on -- and if approved, that will sort of outline when we will have our permanent code. But as most know, before we get a permanent J-code, we will submit for pass-through. Pass-through comes off, depending on the timing of the approval, anywhere between a month to three months following. That pass-through code will help in the surgery center as well as the hospital to get -- to no longer have a miscellaneous code. So we'll go from a miscellaneous code to a pass-through code for a period of time until we get our permanent J-code.
Liz Barrett -- President and Chief Executive Officer
I think just to add one comment that you made, as some -- as you know, the CMS right now is considering moving to a quarterly review instead of an annual review for permanent J-codes. And we're hopeful and believe that by the time we get approved, we're hoping that they have then moved to this quarterly review, and that will obviously expedite our ability to get a permanent J-code. We don't know yet that and we don't have that built in, so Jeff and the team is ensuring that regardless of whether that happens or doesn't happen, that we have everything in place that we need to ensure reimbursement for these physicians. So that -- because that will obviously be something that will be important to doctors.
Raghuram Selvaraju -- H.C. Wainwright -- Analyst
Okay. Great. And then I wanted to ask about the UGN-102 sort of long-term treatment regimen. As I understand it, in the OPTIMA study, you're looking at an initial six-week regimen where the drug is instilled weekly and then monthly instillations after that on a long-term basis. And just wanted to better understand how you're thinking about this in terms of the context in the real-world setting and real-world practice, potentially in the situation where the drug is approved, whether you think there is likely to be a need for the long-term sort of monthly recurring installations, if those can be dispensed with after a set period of time. And if so, what that period is likely to be?
Mark P. Schoenberg -- Chief Medical Officer
Thanks for the question. And this is Mark. And I'll -- let me just clarify one thing. There actually is no maintenance arm in the 102 program. It is an induction arm or an induction protocol once a week for six weeks, and that's the treatment protocol for this group of patients. And then they enter follow-up. So there actually is no maintenance. That was removed from the protocol. And our expectation is that, that would be the core application in the non-muscle invasive bladder cancer space for this technology. The reason is because maintenance with mitomycin in fact is used very haphazardly in the community and it is not entirely clear that it is of therapeutic benefit. And most physicians would, in fact, use an induction course as the initial foray, where they're using mitomycin in water as an adjuvant following surgery. So, we have no intention at this time of using a maintenance protocol. And that might be something people would explore later on, but not for this trial or for this initial foray into using the 102 product.
Liz Barrett -- President and Chief Executive Officer
I think one of the things that we've really been focused on is doing what we believe is in the best interest of the patients. And we think that it's burdensome to have monthly, and to Mark's point, we don't really know if there's a benefit or not. So we really have to do a study with and without. And I think that given the results that we saw in 101 and our expectation around 102 is that patients really don't need the maintenance, and that is though why -- also why we believe that doing a retreatment study, and we shifted away from maintenance and added a retreatment study. And I think in whatever protocol we move forward with in 102, we would want to do the same as well. So hopefully, that's helpful.
Raghuram Selvaraju -- H.C. Wainwright -- Analyst
Okay. Just two very quick clarifications on that point, then. If we look at the possibility of applying this solely in a retreatment context, and I think, Liz, you and I had discussion about this before. The possibility might be that you don't necessarily need six instillations that you could potentially get the optimal result with a couple fewer instillations. So I was wondering if you could maybe comment on that. And also, referring to what you were saying earlier regarding the potential design of a pivotal program and the possibility that you would have to do some kind of comparator controlled work. If we assume what might be the design of a pivotal study involving a comparator control, what might be some options for that comparator control in this study?
Liz Barrett -- President and Chief Executive Officer
Yes. I think that a comparator control would likely be against TURBT, as Mark stated, because that's the current standard of care. I'll give you my sort of point of view on the six instillations and then let Mark comment.
At this point, there is no data, right? There's no data that suggest that doing fewer than the six will work. We do know that some patients actually ended up with a PR. And one of the questions that we have, one of the things we may want to look into the future is, if those patients had a PR after six weeks, would those patients benefit from actually incremental instillations, and might a longer treatment help those patients from a -- that were at PR to get to a CR? So I think that you will end up with some patients that have more and some patients that have less. But our sort of perspective right now is that we really need to do the six instillations, that's the data that we have.
Doesn't mean that we won't, in the future, look to do other studies because at the end of the day, we want to make sure that we're doing what's in the best interest of the patients and the physicians, and we believe that, that will ensure rapid and more broader adoption. But at this point, there's no data that suggests that below six treatments is actually going to be effective. Mark, I don't know if you want to add...
Mark P. Schoenberg -- Chief Medical Officer
Yes. I just want to make sure that I respond to one thing that Ram may have brought up here. I think we are mixing products and trials when we're talking about this. So the retreatment program is for the upper tract. We don't have any retreatment information about the use of 102 in non-muscle invasive bladder cancer, so that would be a subsequent program. I just want to make sure that, that was clear.
Raghuram Selvaraju -- H.C. Wainwright -- Analyst
Yeah. That's very clear. Just one very quick last item for me, which is do you have any indication at this juncture, based on prior experience with mitomycin C, that more instillations or longer duration of therapy would be necessary in the retreatment context? Or is that just purely speculative? We just -- as you say, there's very little data here, we can't really hazard a guess on that front.
Mark P. Schoenberg -- Chief Medical Officer
Well, what we know, and I think that we have talked about this before, and really the fundamental basis for why we believe 101 and 102 are going to be valuable clinically is because the technology addresses a core requirement for the efficacy or the optimal efficacy of mitomycin, which has really been known since the 1990s, which is duration and high concentration of medication. So because we're able to deliver to the tumor high concentrations of medication over an extended period of time, we believe that this is going to provide a much better performance profile for the active pharmaceutical agent in this context. So I think in some ways, we're already addressing the question you were asking. And what you're asking is a very interesting question which we believe the trials are answering, which is, if you provide a higher concentration of drug for a longer period of time, do you see better results? And we are encouraged, based on our results to date that, that in fact is correct.
Liz Barrett -- President and Chief Executive Officer
I think the other thing that's really important is think about it in the context of chemotherapy in patients who -- in other tumors outside of urological area, and if you respond to chemotherapy and you're chemo, considered to be chemo-sensitive, which is very analogous to this patient population, then the expectation is, and these patients typically get retreated with the same treatment if the treatment worked the first time. So we actually expect, and so I think to Mark's point, there's a really good rationale for why we believe that retreatment will work. I think the other thing just in the -- to go back to the number of instillations. This -- and Mark, I actually would probably use your prior comment more on this because you were around before I was. But this is fairly typical for a urology office. And they're used to doing not just this procedure, but other procedures in their office, that the six instillations is an area in which they're used to and this is typically what they do. So we don't expect that we will be able -- we don't expect that, that's actually going to be an issue for us. We think that the protocol, that the data we have, and we believe that they will do that. I don't know, Mark, if you want to add anything.
Mark P. Schoenberg -- Chief Medical Officer
No. I think it's a very important point. One of the constructs that urologists use in thinking about intravesical and intra-catheter [Phonetic] therapy is this notion of weekly instillations for six weeks. And we wanted to make sure that we were doing something in designing this therapy that is comfortable and familiar to urologists. So that also informs frankly the treatment paradigm, familiarity, the use of the drug in prior settings in this way. And it's -- and we have seen this in our clinical trials that when you talk to urologists about this type of a treatment paradigm, they are readily accepting of it because it's very familiar.
Raghuram Selvaraju -- H.C. Wainwright -- Analyst
Great. Thank you very much.
Operator
And our next question comes from Chris Howerton from Jefferies. Please go ahead.
Chris Howerton -- Jefferies -- Analyst
Great. Well, I'll try to make this quick. Thank you for taking my questions. I guess for 102, I think, Liz and Mark, you said a couple of times, if the data are positive. Maybe you could just help us frame what would be positive. What's a number that would get you excited or at least start the conversation for the next steps?
Liz Barrett -- President and Chief Executive Officer
Yeah, Mark?
Mark P. Schoenberg -- Chief Medical Officer
I think that given the fact that as -- I think Liz has said on a number of occasions, and we've talked before, Chris, about this. We've chosen people for this trial who are effectively surgical failures. People who have recurrences, people who have larger tumors, multi-focal disease, sort of classic intermediate disease patients who are very familiar to urologists in practice and who represent a real challenge because our standards of care just don't work. And these are elderly individuals for whom repetitive surgery becomes more and more of a challenge as they age and they will have their comorbidities that interfere with safe operations, so to speak.
So for us, I think if we were able to achieve a CR rate after the initial induction course of therapy of 50%, and if at 12 months, 50% of those people were free of disease, that would represent, I think, a significant clinical step forward for this population. Because remember, these are people who are likely to recur often more than once within the course of 12 months. So that should give you a ballpark for what we are thinking internally and would represent success and a reason for an informed conversation with the regulatory agencies.
Chris Howerton -- Jefferies -- Analyst
Excellent. Okay, yes, no, that's [Indecipherable]. Thank you, Mark. And then I assume we'll discuss this on September 24th, but I guess I'd ask now. For 201, I think you're talking about potential combinations. Are there particular mechanisms that you think are attractive in this case for this high-grade non-muscle invasive bladder cancer?
Liz Barrett -- President and Chief Executive Officer
Yeah. I think that what you'll see on September 24th is some of the pre-clinical data that we have, and it's in combination with checkpoint inhibitors, which is where we really think that we'll get the most -- patients will get the most benefit. So I think moving forward, our plan is to do 201, a TLR agonist, in combination with checkpoint inhibitors going forward. So I think that we're continuing to do more pre-clinical work around there and ensure that we're optimizing the best strategy. But I think you'll see some of the data that we've seen that makes us really bullish on the opportunity to move 201 forward.
Mark P. Schoenberg -- Chief Medical Officer
Okay.
Chris Howerton -- Jefferies -- Analyst
All right. Well, thank you very much for taking the questions, and obviously look forward to the Analyst Day in just about a month.
Liz Barrett -- President and Chief Executive Officer
Great. Thank you, Chris.
Operator
Our next question comes from Matt Kaplan from Ladenburg Thalmann. Please go ahead.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Thank you. Good morning. Wanted to just touch based on the 101 NDA filing, I guess, given that you've submitted the CMC modules. I guess, what's the rate-limiting step for completing that NDA later this year?
Liz Barrett -- President and Chief Executive Officer
Yeah. The rate-limiting step, as we've talked about all along is six-month durability data on 75%-plus of the patients. So if that was -- it's really, we -- like Mark said and I said earlier in my comments, we've locked the database to ensure that we have at least 75% of the patient population at six months. So I was just making sure that we had quote unquote, 75% of patients at six months. So right now, we're just going through your typical cleaning of the database with the clinical data and capturing all of the data and ensuring the quality of the data because what's most important to us is that we ensure robust submission.
We've been very happy so far with the response from the FDA. We know that when we put the CMC module in, as we've said, that we've already gotten acknowledgment from that. We know they're reviewing it because we've received a couple of questions from them around our CMC. So, we don't actually see any big barriers right now. It's really simply a matter of getting the clinical data together and submitting that. And we expect to do that in the Q4 time period.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Okay. Great. Thanks. That's helpful. And then I guess given the relative near-term for potential approval of 101 for UTUC, just wanted to talk a little bit about kind of your commercial preparations that are ongoing. And kind of you alluded to this a little bit before, but what are you thinking of pricing right now? And can you detail kind of the support systems that you'll have in place to facilitate the reimbursement process for our physicians and patients alike?
Liz Barrett -- President and Chief Executive Officer
Sure. Thanks, Matt. And as I've said before, we have Jeff on the phone. But before I put him on the line -- but before I turn it over to Jeff, I'll just reiterate the fact that we're not providing pricing information at this point. We actually haven't even finalized our price. We're still gathering data, doing pharmacoeconomic study around this patient population and current standard of care as well as looking at what we believe the best price will be. What we have said in the past and will continue to say is that quote unquote oncology-like pricing.
The team -- Jeff and the team have been very busy moving things forward. And I'll turn it over to him and he can talk to you about specifically what they're doing around reimbursement and other preparations for the commercial launch. But I just want to say that we're really thrilled to have Jeff, and he has built a great team so far of very experienced colleagues in the area of uro-oncology. So Jeff?
Jeffrey Bova -- Senior Vice President of Commercial
Sure. Thanks, Liz. So we're working on prior to launch, we have a couple of campaigns that we've been focused on. One is primarily for the patients. Prior to UGN-101 coming along, there really wasn't a resource for both the patients and the physicians with regards to their disease. And so, we have a website, UTUC.com, that with the help of our advisors, provides a lot of clarity in and around the patient's disease, their options at the current time. And we've had a positive response for that, because as I've said before, before UTUC.com, if you did go to try to research the disease, it was very challenging and difficult. So we've got that for a recourse for both the patients and the physicians.
The other is the unmet need campaign. And we're calling it intactivism [Phonetic]. And the intactivism is obviously the importance of keeping your kidney, so keeping your kidney intact. So there's education that's in popular urology journals right now. This will be something that the rest, once they're brought onboard, will also highlight when they're in the field, just the unmet medical need around keeping your kidney and keeping it obviously intact.
The last thing obviously that we're doing is gearing up for launch. So as Liz alluded to earlier, we are close to hiring the first-line sales management team. Once they're onboard, they will begin to hire the representatives. The representatives will have a couple months to discuss the unmet medical need campaign as well as begin to profile the accounts in anticipation of approval.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Thanks for the added detail. Then I guess just shifting gears a little bit, just I guess more for Liz, kind of plans to explore the use the RTGel technology outside of urology. Are there indications, are there potential uses of that?
Liz Barrett -- President and Chief Executive Officer
Yeah. No, I think there are a lot of uses. We've talked -- one of the things we are really working on right now is a longer-term strategy for UroGen Pharma. I think it's safe to say that we -- our focus is really on uro-oncology, right? So, in the urologic -- urology space and the oncology space, we would want to own any RTGel or partner and be in a collaboration. I think outside of uro-oncology is something we would look to outlicense to other partners interested. We have gotten a lot of enthusiasm from physicians that when we sit down and talk to them, they will give you a laundry list of all of the potential uses for the gel.
And we have a Head of BD that works for -- reports into Peter, and they're obviously fielding any requests that we have and for this -- and we've been talking about does it make sense for us to be more active in this space. And again, I think right now, we want to make sure that we are all in, in the uro-oncology space. That's our focus, that's our priority. The team in Israel, so the early clinical team, had been working on some other areas, and we've really focused them on making sure that they're really focused on uro-oncology opportunities. And again, outside of that, we would look to outlicense.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Thanks a lot. Congrats for the progress.
Liz Barrett -- President and Chief Executive Officer
Great. Thank you.
Operator
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.
Liz Barrett -- President and Chief Executive Officer
Thank you, operator. I just would like to say that we think we've made important progress so far this year. It's been a very, very busy year for us in executing some very critical events, i.e., around advancing our portfolio as well as ensuring a robust submission to the FDA. So we're excited about our meeting on September 24th, where we'll be able to share more detailed data around all of these opportunities. And we hope that you'll be able to join us. So appreciate you joining the call today, your continued interest in UroGen, your active questions. And we're always here to answer anything that you might have. So just want to say thank you to everybody, and we'll talk to you soon. Hopefully, see you in September. Thanks. You can disconnect now, operator.
Operator
[Operator Closing Remarks]
Duration: 66 minutes
Call participants:
Kate Bechtold -- Senior Director of Investor Relations
Liz Barrett -- President and Chief Executive Officer
Mark P. Schoenberg -- Chief Medical Officer
Peter P. Pfreundschuh -- Chief Financial Officer
Jeffrey Bova -- Senior Vice President of Commercial
Benjamin Burnett -- Stifel -- Analyst
Turner Kufe -- JPMorgan -- Analyst
Paul Choi -- Goldman Sachs -- Analyst
Boris Peaker -- Cowen -- Analyst
Raghuram Selvaraju -- H.C. Wainwright -- Analyst
Chris Howerton -- Jefferies -- Analyst
Matt Kaplan -- Ladenburg Thalmann -- Analyst
