Good day, and thank you for standing by. Welcome to the UroGen Pharma ZUSDURI Approval Investor Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you may press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vincent Perrone, Head of Investor Relations. Please go ahead.
Thank you, Operator. Good morning, everyone, and welcome to UroGen Pharma's ZUSDURI Approval Conference Call. Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; David Lin, Chief Commercial Officer; and Chris Degnan, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our latest SEC disclosure documents. You're cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. I'll now turn the call over to Liz. Liz.
Thanks, Vincent, and thanks to everybody for joining today. I do want to take a moment to do two things. One, thank everybody on the call and all of our investors that have had confidence in us over the years and have stuck with us, and even through this, I would say, roller coaster ride over the last few weeks. I just want to say thank you. It is very much appreciated. The outreach has just been phenomenal, even after the ODAC, before the approval, and obviously since the approval. The second thing is I want to say these things do not happen by accident, and I want to really send a sincere thanks to my team at UroGen. The team worked extremely hard. We conducted very, very good studies over the years. The data is phenomenal, as you guys all know. Never been seen in this patient population before.
I think our filing was very strong. I think the presentations at the ODAC were very strong. Importantly, the work that we did post-ODAC and prior to approval. I am very, very thrilled to be able to be here with you today in this remarkable event and very much a game changer, not just for us, but for patients as well. I am sure you guys have lots of questions. We will get to those. I do want to just also thank the FDA, frankly. I think that if I learned anything through this process, what I learned is that I believe that we have a shared goal. Even though we may look at things very differently, I think at the end of the day, we both want what is in the best interest of patients. I think we learned a lot during the situation, and not necessarily unanticipated.
One of the things that we always knew is being in the ODAC division, Oncology division, with really a product and a disease that is treated by urologists would be challenging. On the other hand, you know that what's nice about the Oncology division is they understand cancer, and they understand the impact that cancer has on patients. I do want to give a shout-out to the FDA. Unlike, I think, what's been said in the media the last few months, the FDA is not in pharmaceutical companies' pockets. I mean, they are very independent. They're very rigorous, and they've definitely put us through it. I think that given the ODAC, and we can obviously talk more about that, we really felt like the way that the ODAC was panned out, that we kind of were set up with the question around the randomized controlled trials.
I think they felt that way too. I mean, I can't speak for them. They never said that, but we know that it definitely conflated the issue and Mark did a nice job in our meetings with them talking about that. I think the other thing was really the strength of urologists and the voice of the urologists at these meetings also had a big impact. We can talk more about it, but don't want to spend too much time focused on the past. Want to really focus on the future. I will tell you, and we have David here today. As you heard, we expect to be able to ship product in a couple of weeks.
There is product in the U.S. already, and we obviously have to do the labeling and all of that, but we put ourselves in a position where within a couple of weeks, we could be ready to go. The plan right now is a July 1 launch. David can get in more detail with you, but the expansion was we had sent out contingent offers, and those offers will have been given out yesterday as soon as we got the approval. We will have another 30-plus reps joining the organization. Until that time, obviously, our current team has been trained and ready to go. Like I said, David can talk more about our launch readiness in a moment. We will file for unique J code by the July 1st deadline, which should give us the permanent J code by January 1st, which is what we expect.
The list price per vial is going to be $21,500. We believe that's the right balance and the right value for the therapy, especially given the unmet need, but also importantly, the data that we've shared so far. I think, again, David can talk more about it, but we've identified early adopters. A lot of those are JELMYTO users, but also accounts that we believe would not be or are willing to write for the drug without a permanent J code. We do have both institutions and community practices that are very comfortable doing that. The team has identified what they believe will be the accounts to go after in the beginning. That doesn't mean we won't be calling on everybody. It just really means that we'll put a focus on those accounts that we know are there and ready to go.
Lastly, and obviously, Chris can talk more about this, but it's March 31st. We reported $200 million in cash, which we believe is sufficient to support the commercial launch of UGN-102 and provide cash runway through profitability. While we also focus on our near term, we're also committed to driving a long-term sustainable growth company. We will continue to evaluate opportunities going forward and capital needs that would support that vision. Expect to hear more about that as we go forward. I think we've talked about it before. We've got 301, we've got 201, and now we have 501.
In addition to a lot of life cycle trials that we want to do with UGN-103 as the next generation, as we move into high-grade disease with UGN-103, as well as maybe even we have to think about what we're considering other patient populations in the low-grade, intermediate-risk patients. Again, thank you, everybody, for joining us today, and we can open it up for questions.
Thank you. As a reminder to ask a question at this time, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from the line of Tara Bancroft with TD Cowen. Your line is now open.
Hi, good morning. I just want to offer my sincere congratulations. This is a wonderful outcome, so congrats. I think for me, my question is going to be about expectations, both for cadence and magnitude, especially with the focus on potentially with institutional and hospital settings for the miscellaneous J code. If there's any potential maybe for a bolus as a patient due to pent-up demand for a therapy or anything, yeah, just expectations for the initial launch.
Yeah, and Tara, thank you. You've been a great supporter. Really appreciate it and appreciate your comments over the last few weeks as well as your wishes. Thank you so much for the support. I'm going to turn it over to David. I will say before I do, we do not expect Ebola as a patient. He can talk to you why. David, do you want to just talk about the expectation around cadence?
Yeah, absolutely. Thanks for the question. Yeah, we'll start with the question around the bolus. We don't anticipate a bolus, but in talking to practices and urologists through the last period of six months as they've been tracking our NDA, they do know that these patients exist. Just given the standard of care, there are options today which they undergo, as you know, with TURBT, intravesical chemo. While they're really excited to have a new option, we just don't see a bolus being present right now, but they will begin to identify patients as we engage in promotion. In terms of the cadence and magnitude, our focus at the launch is really to establish a very strong beachhead.
As Liz mentioned, we are going to focus on a cohort of, or I'll say extra focus on a cohort of urologists who have demonstrated a willingness to adopt new therapies, particularly in the early parts of launch. Many of those are JELMYTO writers already, and we will focus on a specific group of not only urologists, but also their affiliated sites of care. We can enable them to get clinical experience with ZUSDURI, whether it's in their clinical, their community practice, or in an affiliated hospital outpatient setting. As we turn the corner into 2026, we'll expect to expand our penetration as well as the number of sites of care that we're interacting with.
We'll consider it a very focused start, but then broadening over time, and that will be very consistent with how we've learned through our research and how to engage these urologists. Thanks for the question.
Great. Thanks so much.
Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is now open.
Hey, good morning. Thanks for taking my questions. I want to congratulate you on this great, great achievement and the FDA approval after a very, very interesting ODAC discussion, obviously. A couple more questions just around the commercial opportunity. You mentioned the list price earlier. Could you just comment on perhaps what proportion of the market is expected to be Medicare-driven and how we should think about net price in that market segment? The other question I had is, I think you talked about this 59,000 patient opportunity per year in the U.S.. Maybe talk about what fraction of that opportunity the initial commercial effort is addressing perhaps in the coming years and how we should think about the trajectory given the size of the opportunity. I'll leave it at that. I have a couple of follow-ups.
Okay, great. Thank you. And thanks again for the support. Chris, I'm going to ask you just to talk about the net price assumptions and then turn it over to David to answer the other questions. I'll chime in if we miss anything. So Chris.
Sure. Sure. Michael, I would think about ZUSDURI net price similar to what we are realizing for JELMYTO, maybe slightly better. Just a reminder, JELMYTO, we are realizing about an average 75% GTN.
David.
Yeah. Okay. Hi, Michael. Yeah, in terms of the patient population, I think if we look at the overall payer mix, we do expect Medicare to be the majority. So 65%-70% of the population is expected to be Medicare, very consistent with the patient demographic. To your point about the overall addressable population, you're right. Where you look at the world is about 59,000 patients who are recurring every year. The way we think about that is obviously there's going to be very low hanging fruit, which is not really going to be the focus of our messaging. We're going to talk about recurrence because that really is the problem that these urologists are trying to solve. We'll be identifying patients along with the practices. We'll look at early recurrence. We'll help them identify frequent recurs.
Of course, as I mentioned, the low hanging fruit that they're already thinking about is going to be the surgically ineligible patients. That's a group that's often you hear about as frail, and they really just can't undergo another anesthesia. Physicians have well understood that. We heard that from the research. Our main goal in terms of promotional messaging is to leverage the compelling data that we have from our phase three trial to help them identify the early recurs, the frequent recurs. When you add all that up together, that's probably one-third of the addressable population right off the bat. Thanks for the question.
Okay. Super helpful context. I just had one more sort of a clinical type question. Sort of coming out of the ODAC meeting, and as we think about UGN-103 and the development path for that product, do you plan any changes to the trial design or the market strategy, or are you sticking with what you've started so far?
Yeah, I think that that's something that we are working on, and we will be in contact with the FDA to confirm what the expectation and needs are for UGN-103. We don't have any additional information at this point. I can tell you that for our purposes internally, we are well prepared and plan to do more studies with UGN-103 anyway, regardless of what the FDA says. The strategy hasn't changed, and we still believe that no matter what, we can actually continue to launch UGN-103, have the time to switch the market before our patent expiry. The strategy hasn't changed at all, but we have not had the opportunity to discuss any other changes with the FDA.
Look, I also failed to mention in the intro, as you guys saw with the label, we got the full recurrent low-grade non-muscle-based IR non-muscle-based bladder cancer, and there were not any randomized control studies as any post-marketing commitment. I think part of that is driven by the fact that it is very difficult to do one. We kind of got off track right in the conversation at the ODAC, but there were reasons, very, very good reasons why we did not continue with the randomized control trial. Unfortunately, those reasons still exist. I think the other thing that was recognized was we can do an adjuvant study. Those are easy to do. That is what our other companies are doing in this space. Then you have to do a surgery with the adjuvant.
It's going to be this sort of balance between randomized control trials, but now that UGN-102 is out there, there's something to compare to. Anyway, I just bring that up in the sense of as we think about what we do in the future, some of the challenges that we had have not gone away. Those are still conversations we need to have with the FDA.
Great. Thank you. Yeah, congrats again to the approval here.
Thank you. Appreciate it.
Our next question comes from the line of Raghuram Selvaraju with H.C. Wainwright & Co. Your line is now open.
Thanks so much for taking my questions. Once again, congratulations. I think this is a landmark achievement not only for the company, but also for non-muscle-invasive bladder cancer patients who historically have really not had much in the way of pharmacotherapy options. I wanted to, first of all, drill down on the number of vials you expect on average to be used per patient. If you can comment at this juncture on if you look at an annualized basis, approximately how many treatments might be administered in order to address the recurrence issue?
Yeah. Okay. Thanks, Ram. And you've been here from the beginning, so I just want to put a special shout-out for you. I appreciate it. I'll turn it over to David to answer the question. I'll chime in if there's any additional information. David.
Yeah. Hi there. Thanks for the question. In terms of the number of vials per patient, we expect that to be somewhere between five and six when you look at it across the totality of the business. That somewhat mirrors JELMYTO. That's our working assumption right now. Given the ease of administration and the overall side effect profile, one of the things we do anticipate here is that when physicians prescribe ZUSDURI, we'll, for the most part, expect them to see the full course of therapy of six doses over six weeks. Ram, could you remind me the second part of your question was the number of treatments?
Yeah. Number of treatments on an annualized basis on average that you anticipate for a typical patient who's needing to use this product to manage recurrence risk?
My perspective is that it's a little early to tell. Given the compelling data that was generated in ENVISION, the expectation that we will have going in is that once a patient is treated, they're going to be monitored with their physician in typical form. Right now, I don't expect, I wouldn't expect personally, to see anything that's very different than our ENVISION trial results. I think we'll have to just learn as we go through the market and get customer feedback. I think for the most part, they are very, very enthused by the overall clinical trial results. That's the way they're thinking about treating patients.
About treating patients.
Okay. Ram, let me just clarify. Are you just asking within a given year, will a patient be able to get all six? Is that what you're asking?
No, no. I understand that in an individual treatment cycle, you're looking at the administration of five or six vials' worth of product. I think ultimately, if you look at the ENVISION trial results, clearly after a patient has been treated with UGN-102 once, one would expect them to remain recurrence-free for an extended period of time, right?
Correct. Yeah. So yes, are you asking would patients get retreated in a year?
Yes. What proportion of patients you might expect to be retreated in a year?
Yeah. I mean, very few, right? To your point, if you look at the data, and we haven't reached our median yet, but if you look at the data, the expectation is that most patients will be out a couple of years before needing another round, whether it's obviously we will be that's one of the things that we'll be wanting to answer is retreatment and how patients do with retreatment. We will expect that we'll see some retreatment. We see it with JELMYTO. There's no reason that assuming that they get a good response, they wouldn't, but I would not assume that it would be within a year. I think that it's a good question. Sorry for the confusion. I wasn't really sure what you were asking, but I think that hopefully that's helpful.
No, that's very helpful. Then just two other very quick ones, if I may. Firstly, you talked about the extent of the magnitude of the sales force expansion. I just wanted to get some clarity on if you feel comfortable that that level of magnitude of sales force expansion would enable you to appropriately target at least that initial third of potentially eligible patients that you consider to be the lowest hanging fruit. In point of fact, with that level of sales force staffing, you feel reasonably confident in being able to fully penetrate the part of the market that is likely to be most accessible?
David, you want to answer that question?
Yes. Yeah. We're very confident that the overall size of our field organization is more than capable of addressing that particular segment. Not only that, but also the total population. As was asked in a previous question, it's really a phased approach. We're going to focus on an initial group, and then we'll broaden our reach over time. Turning into 2026, the HCP penetration will increase even further. Whether it's the sales rep or the team that supports them, like the nurses and the reimbursement managers, we're very well prepared. We know who those early adopter cohorts are and very confident in our ability to address them in this initial stage.
Yeah. The only thing I'll add, Ram, is that we've sized it for the entire market, not just for the initial, right? Actually, we had added more than what the initial evaluation suggested. That's because we know that these are high-touch cells. We know that we need people in there. Because of that, we actually added more reps. That doesn't mean we won't add more if we feel like we need to going forward. At this point in time, we feel very good, as David said, very good about where we are, not just for the initial stage, but to be able to reach all of the patient population. I think we're reaching like 85%-90% of the patient population with our sales team.
Just very quickly, I wanted to ask you folks about one aspect that came up during the ODAC discussion, which was this question around how many TURBT procedures are likely to be avoidable in the context of deployment of UGN-102. I just wanted to ask if you, in your discussions with the prescribers out there, to whatever extent you've had those discussions both leading up to and after the ODAC meeting, to what extent there is a prevailing view that one might only be able to say that the initial TURBT might be avoidable. This was a point that was raised during the ODAC meeting. Personally, I do not think that this is really supported by the data available. I think the data available obviously provides ample evidence of durability and indicates very strongly that multiple TURBT procedures can be avoided.
I just wanted to ask if this alternate view has in any way arisen in your discussions with potential prescribers. Thank you.
Yeah. I'll answer that. No, it hasn't. I'm going to ask Mark to just comment on that discussion at the ODAC and why it was a premature discussion. Mark, you want to just talk about that?
Yeah. Sure. Good morning. Thanks, Ram. I think, as Liz is, I think, alluding to, what got missed in the ODAC, I believe, and I think to some extent this is because of who we were talking to, largely non-specialists with no familiarity with this operation or disease, the importance of missing or skipping that first TURBT is huge. That is an operation that is avoided in virtually all of the patients who received UGN-102 in the trial. Remember the complete response rate was in excess of almost 80%. You can say charitably that only 20% of people ended up having to have an operation. The durability to date, and we have not reached the median, shows that the vast majority of these people still do not have to have an operation 18 months after that initial intervention.
No, I don't think that is going to be a talking point for prescribers. In fact, quite the opposite. I think urologists, I'm speaking for myself included, will view being able to avoid that first TURBT as very advantageous for many patients. There obviously is going to be the very beneficial impact of the long durability so far demonstrated by UGN-102 in the context of treating this patient population that will also be seen as a benefit. I guess the short answer is no. I think we have to flip it around and say, "Look at the benefit of skipping that first TUR.
You missed the first TUR, and so far, long-term, it looks like you're not going to need one for a long time afterwards. In the population we studied, 50% of those patients, if they'd had a TUR as their first therapy, would have needed another TUR within about a year.
Yeah. I think that's important. The durability point is what's important, right? We hadn't finished our durability. You were looking at data at the ODAC that was premature, and we only have the data up until a certain period of time. I think that that was a discussion that was, again, unfortunate, but a real lack of understanding of the disease. Thanks, Ram, for the questions.
Really appreciate it. Thanks for your patience once again.
Thanks.
Our next question comes from the line of Paul Choi of Goldman Sachs. Your line is now open.
Hi. Thank you. Good morning. Congratulations to you, Liz, and the team. Very great positive outcome, and particularly on your leadership for keeping the faith here. My first question is regarding the commercial strategy and just how you're thinking about potentially pivoting or expanding following the establishment of a J code. Just any color there would be helpful. Secondly, for modeling purposes, just with regard to the capital structure, is it your plan to access the next tranche of debt that's available to you under your financing agreement? The last one, just in modeling, can you maybe remind us of what the royalty rate is associated with the UGN-102 approval that kicks in now that the drug is approved? Thank you very much for taking our questions.
Sure. No problem. Thanks, Paul. Appreciate it. Appreciate the kind words. David, can you just answer the question on once we get a J code anticipated changes? And then Chris, you can answer the financial question. So first, David.
Yeah. Thanks, Paul. As we mentioned, at the initial part of the launch, we're going to focus on those prescribers who've already demonstrated a willingness to prescribe new therapies during a miscellaneous J code period. It doesn't mean that we won't talk to more offices because we'll be continuing to share the clinical data from ENVISION as part of our promotional message. What it will enable us to do is, following receipt of a permanent J code, we'll be able to help them integrate ZUSDURI into practice so they can get their first patients treated. It'll just be a, I'll call it a lighter touch with some of the physicians who we know will really expand when there's a miscellaneous J code.
I'll just say we'll take it in phases, but we absolutely will be touching the vast majority of our overall population over the next six months.
Good morning, Paul. Just on the financial questions. One, from a cash runway perspective, the cash to profitability does not contemplate drawing the additional $75 million under our loan agreement with Pharmakon. From a royalty perspective for ZUSDURI, it's a tiered royalty. It's a 2.5% royalty for the first $200 million of annual sales, steps down to one percent for the tier between $200 million and $300 million, and then it's a half a percent for sales over $300 million.
Okay. Great. Thank you.
Thank you.
Our next question comes from the line of George Farmer with Scotiabank. Your line is now open.
Hi. Great. Thanks for taking my questions. Again, my congratulations as well. A couple from me. The pricing that you arrived at, can you kind of walk us through how you arrived at this, thinking about costs associated with TURBT and the treatment burden, etc.? Liz, I know you said you did not want to look backwards, but could you give us a little bit of insight on what happened with your interactions with FDA after ODAC? Thanks very much.
Yeah. From a pricing perspective, what we do is we do extensive research, extensive research with payers, with physicians, with patients to understand what they view the value is. It's very difficult. There's not a ton of data, and we do have pharmacoeconomic data, obviously, around TURBTs because it ends up being how many—again, this conversation we were having earlier, because of the durability of UGN-102, you have to look at it in that perspective. We will prospectively be continuing that work. It is one of the factors, but the main factor is really around payer and physician and patients around the value. Where do they see the value of the medicine? As we had initially been speaking earlier, we were talking—we said $18,000 and $19,000, but that was before we saw the durability data. Given the strong durability data, we did more research.
You want to balance having any restrictions from a payer perspective or any restrictions from a physician perspective. I think it is one of the things that we have from a pricing standpoint, you have to think about when you have these other medicines that will be coming into the low-grade space from the high-grade space. In our view, if we had come out with a price that was similar to high-grade, it would limit the adoption. It is going to be interesting to sort of see as some of those companies kind of move into this space. What I will say, I am not going to get into a lot of detail, but I think I have shared some of the conversation.
Again, coming out of that, the conversation was really around what happened at the ODAC and the fact that in the beginning, the conversation did not center around our data, frankly. The addition of the discussion right before the vote of a randomized controlled trial, one of the things that did not come out in that and in that conversation was the fact they kept saying, "Well, you did a randomized—so clearly it is feasible." What did not come out was it was not about the feasibility of doing a randomized controlled study. It was about agreeing on an endpoint. That was not our issue, right? That was not just our issue. That was an issue that the FDA was not willing to accept certain endpoints, and we were not willing to accept certain endpoints. That is because we were being put in an unfair—so we had that conversation.
We had the conversation about the data. We had the conversation about the agreement that we had with them where they did tell us that a single-arm study could be the basis for an approval. We had all of those conversations with them. We talked about the patient populations. We talked about post-marketing commitments. I think you see where we ended up because what the conversation came around to is that all of our conversations before the ODAC clearly were very thorough, and we had those conversations. A lot of the issues, like I said, that came up were not new issues, right? These were conversations that we had been having. It was unfortunate that the full story did not really come out at the ODAC, only the little pieces of it, right? It did not paint a very good story from their perspective.
I think they said there were unintended consequences. I feel like that was an unintended consequence. I think they recognized that, which is why we got an approval. We got an approval on the basis of all of the things that we had discussed with them prior to the ODAC. Again, I think that weighing more heavily, weighing and being reliant on the urologists who actually treat these patients, I think that was a big driver as well. I'm not in their mind, so they will not—they do not share a lot of information, but I think that that's kind of where our perspective on it is. I hope that helps everybody. Again, I want to commend our team. We did not have any stone unturned. We had advocates. We had advocates advocating on our behalf during that time period.
I think our team did a fantastic job of having those conversations with the agency.
Great. That's very helpful. Thank you.
Of course. Yeah. Thank you.
Our next question comes from the line of Leland Gershell with Oppenheimer. Your line is now open.
Hey. Hey. Good morning. Let me add my congratulations on what looks like a best-case outcome here. Just a question, Liz, on UGN-103. I know you continue to have deliberations with FDA on the requirements for that to be approved. Just wondering, and maybe Chris, you could add your commentary. With respect to getting toward profitability, should you—I mean, obviously, you've already begun your kind of ENVISION replicate trial for UGN-103, single-arm. Should you have to change course and run what I guess would be like an Atlas-like study, which would involve a lot more patients and probably expense? Could you comment on what impact it may have on your course toward what could be cash flow positive without having to access the capital markets? Thanks.
Yeah. Sure. Chris, do you want to answer that?
Sure. Leland, good morning. When we do our operational planning, we do earmark spend for other development programs. We have headroom within our operational plan to fund additional programs such as perhaps a UGN-103 RCT. Those things are on the table with not necessarily impacting our ability to reach profitability. Thanks for the question.
Thanks.
Thank you. Our next question comes from the line of Aydin Huseynov with Ladenburg. Your line is now open.
Hi. Good morning, everyone. Congratulations as well for the nice outcome, for the approval. A couple of questions from us. Are you planning to provide any guidance for ZUSDURI for 2025 or for the longer term? If no, when do you expect to start providing annual guidance for ZUSDURI just like you do it for JELMYTO?
Chris?
Sure. Aiden, good morning. We are not planning to provide guidance for 2025 as we go through the launch. I think it is fair to assume likely going into 2026, around that time period is where we may start to establish providing guidance for ZUSDURI similar to JELMYTO.
Okay. Appreciate that. The operational guidance that you provided earlier this year, do you think it might change as you roll out the launch as you probably, if you plan to expand the team or maybe expand the expenses for the marketing? Any changes you would expect throughout the year?
No plans to the operational expense guidance that we provided that did contemplate the sales force expansion, the approval of ZUSDURI launched in July. This all lines up with the guidance we provided at the start of the year. No change to our financial guidance there.
Okay. This is helpful. Regarding post-marketing commitments, I think the FDA asked you for a 63-month follow-up period, annual duration of response updates. How do you think these updates would be sort of influential for urologists to prescribe and for payers, essentially, to pay? How important are these updates in your opinion?
Yeah. I do not think the updates to the FDA have any basis, but we absolutely believe that the longer follow-up is important to physicians and understanding what the median time duration durability is. We absolutely will be sharing that with physicians. We will not be looking at updating the label, but we will provide that information to the FDA, and we will expect to see that information published. We definitely believe that physicians want to see, "Okay. How long is the durability?" What we know now, as you guys have seen, the 18-month durability, we will be getting the 24-month durability, not too distant future. All of that will absolutely be important and be a big part of our promotional campaign.
Okay. Thank you. Thanks so much for taking questions. Congrats again with the approval.
Thank you. Yeah, thank you so much. Appreciate the support.
Thank you. I'm currently showing no further questions at this time. I'd like to hand the call back over to Liz Barrett for closing remarks.
Yeah. Again, everybody, just want to say a big thank you. We're around if you have further questions. I'm glad that we finally got here. Glad for us, but most importantly, important for patients. We expect to be able to share this and patients have access to this as soon as possible. Again, thank you. We'll keep you updated on any happenings over the next few months. You may disconnect now, operator. Thank you.
Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect.