Q3 2025 UroGen Pharma Ltd Earnings Call
Good morning, and thank you for standing by. Welcome to the urogen Pharma third quarter 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session to ask a question during the session. You'll need to press star 1, 1 on your telephone, you will then hear an automated message. Advising your hand is raised to withdraw your question. Please press star 1 1 again, please be advised. Today's conference
Recorded. I'd now like to go ahead and hand the conference over to your first Speaker today. Vincent Peron investor relations, Vincent you have the floor.
Thank you.
Good morning everyone and welcome to your agent pharma's third quarter 2025 Financial results and business update conference call.
Earlier this morning, we issued a press release providing an overview of our recent, corporate highlights and financial results for the quarter ended, September 30th 2025.
The press release can be accessed on the Investor's portion of our website at investors.com.
Joining me today are Liz, Barrett president and chief executive officer, Dr. Mark schenberg chief medical officer, David Lynn, Chief commercial officer and Chris Denon Chief Financial Officer.
On today's call, we will be making certain forward-looking statements.
These may include statements regarding our ongoing, commercialization activities related to gelato and Zuri our ongoing and planned clinical trials, and non-clinical trials, commercial and clinical development, milestones market and revenue opportunities. Our commercialization strategy and expectations as well as anticipated data regulatory filings and decisions.
So, story being the primary growth driver for your agent, the potential benefits of our products and product candidates, future R&D efforts, and milestones are corporate gold and 2025 financial guidance, among other things.
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 earnings, press release and latest SEC disclosure documents.
You are cautioned not to place undue reliance on these forward-looking statements, and you disclaim any obligation to update these statements.
I'll now turn the call over to Liz Barrett chief executive officer.
Thank you Vincent. I'd like to address what I know is on everyone's mind and that is the progress of this this Dury launch. While we had expected a faster uptake, there are many factors that support our belief that the near and long-term opportunity for history is on track.
The preliminary demand revenue for October is more than double the previous 3 months, demonstrating increased, usage, and adoption importantly, our patient enrollment forms are pests. In Q3, we're actually on track with our initial expectation, but as we've communicated, it is taking longer to convert a pep to an actual patient being dosed.
We believe the delay is driven solely by logistical and operational challenges including reimbursement. Concerns with a miscellaneous J code.
Pest continued to grow and are currently on Pace with Jomo, after only 4 months on the market.
Since launch position, enthusiasm has been encouraging this clear recognition of the need for new therapeutic options for these patients and our Market access team has executed well to secure broad coverage across major payers. I am pleased to say that we do have paid claims
Requires formal approvals, before a physician ability to use. Remember, we are changing the way Physicians practice and the story is the first and only FDA approved treatment for patients with low-grade intermediate risk, non-muscle invasive, bladder cancer,
The story, addresses, an estimated 5 billion annual market, and we are well positioned to take advantage of this significant opportunity.
We remain confident in the long term potential versus Dury to deliver an important advance for patients.
Becoming standard of care and delivering over 1 billion dollars in Peak Revenue.
We expect to see an acceleration in adoption. Once the permanent product specific J Code goes into effect on January 1st 2026,
David will provide more details on the launch in a few minutes.
Turning to jumo, we delivered another solid quarter with net product, revenue of 25.7. Million representing a 13% increase in underlying demand Revenue over the same period in 2024. Now, 5 years post-launch jumo continues to demonstrate its clinical value and prescriber confidence remains strong
With our expanded field team, we see additional opportunities to drive further growth.
On the clinical front, we continue to advance our next Generation mice and programs. We are pleased to see the 3-month complete response rate from Utopia is consistent with what was observed in The Envision trial and our plan for a New Drug application or NDA submission and approval is on track.
We plan to submit an NDA for UGM 103. In the second half of 2026 with potential approval, anticipated in 2027,
This is a very exciting time for Urgent. We've entered a new phase of growth, from a position of strength, with a solid balance sheet, a capable and focused team, and a portfolio that positions us for durable long-term success.
We remain Guided by our mission to bring meaningful new treatments, to patients and deliver sustained value for our shareholders. I will now turn the call over to Dr. Mark Schamberg mark.
Thank you, Liz. In The Envision study. This is steury, demonstrated a compelling and clinically meaningful profile. With 80% of patients, achieving a complete response at 3 months and 80% of those patients remaining disease-free at 12 months and remarkably 72% at 24 months.
It's important to note that the story and median duration of response has not been reached.
This level of sustained, response is unprecedented and highly meaningful for a population that has historically faced repeated surgeries and the burden of chronic disease management.
The growing body of evidence supporting zeri was recently highlighted in a comprehensive review. Published in reviews in urology, this October by Dr. Sandeep Prasad, 1 of our leading clinical investigators.
This article reviewed results from our three late-phase clinical trials, Optima, Atlas, and Envision, and underscored the consistency and robustness of Sister's clinical performance.
importantly the review also explored the patient perspective on zeri
Across multiple studies including the phase. 3B home, installation, study and Sub analyses of Optima, 2 and envision patients. Consistently reported that zaz Durie was a less invasive, less painful and less time-consuming alternative to repeated turbt surgery.
Turning to ugn 103, our next Generation formulation for you for low-grade. Uh, intermediate risk, non-muscle invasive, bladder cancer,
Ugn 103 is designed to offer practical advantages over the story including a shorter. Manufacturing process, and simplified reconstitution
We've completed enrollment in the phase 3, Utopia study and are very pleased to report that the 3-month complete response rate was 77.8%.
This is consistent with results. From The Envision clinical trial reinforcing the strength and productivity of our Arty gel platform.
In October, the FDA agreed that our pivotal study, Utopia can serve, as the basis for a New Drug application. We plan to submit the NBA in the second half of 2026 with approval anticipated in 2027.
In June this year we initiated a phase 3 trial UGM 104. Our next Generation might am based formulation for low-grade. Utuc
To ugn 103.
Turning to ugn 301, our anti-ctla for monoclonal, antibody being evaluated for high-grade disease. We have completed a phase 1 dose, escalation study assessing ugn, 301, both as monotherapy. And in combination with ugn 2011, or gem cyb.
The study confirmed proof of concept for our Arty Gel as a viable platform for local delivery of complex immunotherapies.
UGM 301 achieved sustained bladder, exposure of zephyr with minimal systemic. Absorption demonstrating. Our ability to mitigate anti CLA for related toxicities.
The treatment was well tolerated with a favorable safety profile and efficacy signals were observed across cohorts.
However the overall clinical profile did not warrant advancement to a phase 2 study. As such we have made the Strategic decision to discontinue the UGM 301 program and focus our resources on ugn 103 and ugn. 501 in high-grade, non-muscle invasive, bladder cancer.
We plan to share safety and efficacy data in a future publication.
The important takeaway from this program, is that it successfully validates. Our ability to locally deliver complex immunotherapies using our RTL technology. A capability, We Believe will be foundational as we advance future oncology programs,
1 such program is ugn. 501 our next Generation analytic, virus acquired earlier this year.
UGM 501 is designed to selectively destroy cancer cells while retaining potency and triggering, uh, robust immune response.
We are pleased with the results we are seeing in our early work with IND enabling studies ongoing and planned initiation of a Phase 1. Trial in recurrent, non-muscle invasive, bladder cancer in 2026 with additional potential applications beyond the urinary tract.
I'll now turn it over over to the call to David Lynn for a commercial update.
Thank you, Mark.
I will spend most of my time today, discussing the ongoing launch of Zuri.
overall, we remain encouraged by the strong engagement, we're seeing across the Urology community and the early commercial traction, we've achieved
while recognizing the headwinds that accompanied the introduction of a new therapy,
our commercial infrastructure is now fully operational.
By early August, we onboarded trained and deployed 30 new sales representatives, bringing our total to 82 in the field.
Along with our regional operations managers field. Reimbursement, managers and nurse Educators. We now have approximately 130 customer-facing professionals supporting Zuri as well as Joe Mido.
As Liz mentioned, Zuri generated sales of 1.8 million during the third quarter. And we're pleased to report a preliminary demand Revenue estimate of 4.5 million for October reflecting, encouraging early momentum in Q4.
From launched on July 1st 2025, through the end of October. There were 54, unique zust, story, prescribers and 16, repeat resistor prescribers.
I'd like to spend a few minutes highlighting. What's driving? These numbers as well as some of the challenges we're addressing.
First, we're very encouraged by the level of Interest, we're seeing in the Urology community.
Awareness among urologists is strong and we're seeing consistent engagement with our team. To better understand the stories clinical profile and appropriate use in the eligible patients.
Second Market, access progress has been excellent. Is this jury is now broadly accessible to patients through commercial. Medicare and Medicaid Insurance programs with open access to more than 95% of covered lives and approximately 296 million eligible patients.
Third.
operational execution remains a major Focus as it is a complex Network and what we believe is the biggest driver of delayed treatment
we are partnering closely with practices and hospitals to ensure sites are prepared for ordering and administration including distributor on boarding, Pharmacy, workflows, and clinical training,
We now have nearly 600 sites activated and are ready to order and administer the story.
Still, it is a positive sign that the infrastructure and operational Readiness for adoption. Continue to expand.
We closely monitor patient enrollment as a leading indicator of demand.
Eligible, patient. They submit a patient enrollment form or PF.
To our hub.
A clear intent to treat with just hurry.
Weekly path volumes are showing strong growth and are now equal to or in some weeks greater than Joe Mito paths reflecting increasing demand and intent to treat.
We are however, seeing an average, if 45 to 60 day, lag between pest submission and patient dosing.
We believe this is largely because many initial cases are occurring in hospital settings where formulary and pnt approvals can extend timelines.
Our field team is actively working to shorten that conversion window by providing education on streamlining, reimbursement. Workflows accelerating patient benefit. Verification and ensuring sites are fully ready to administer treatment.
Over time, we expect conversions to narrow to 2 to 3 weeks, similar to Joe Mido.
As these processes improve and clinical teams gain experience, we expect conversion rates to increase meaningfully in the months ahead.
As you are aware, we are also navigating the temporary use of the miscellaneous J code.
Which adds administrative complexity for practices, given that the story is a buy and build drug.
Many large community practices have indicated, strong interest in treating resistor, once a permanent J code is available.
We were pleased to announce last week that we have been assigned. The permanent J Code by CMS that will go into effect on January 1st 2026.
in the interim, we prioritize around 2,000 early adopter Physicians, who have shown a willingness to prescribe under a missing Jacob,
Once the permanent J code becomes effective. We expect to see acceleration in adoption. Primarily in the community setting.
Where Physicians tend to be more cautious with new buy and Bill therapies during miscellaneous J Code periods.
This change will simplify reimbursement and significantly reduce several of the barriers. We are currently seeing
taking together while the temporary J Code has presented near-term. Headwinds, we continue to see strong interest expanding the site Readiness and a clear path to broader adoption. As we move into the first half of 2026,
Turning to John Mido, we're seeing continued demand growth and steady utilization among high-performing accounts, our expanded sales force which now also promotes gel Mito. Alongside zhuri is helping us reach more Urology, practices with greater frequency and depth.
In addition gross to net adjustments, have normalized further.
Providing a clearer view of consistent, underlying Revenue growth.
taken together, these Trends, reflect durable, demand, and strong commercial execution, that continue to position John Mido, as a standard of care for patients, with low-grade upper tract, urothelial cancer
I will now turn the call over to Chris to review our financial results.
Thank you, David total revenues in the third quarter were 27.5 million and this consists of 25.7 million in Joel Mito sales and 1.8 million dollars in the story sales.
Joe Mito sales in the same period of 2024 were 25.2 million. However, this included 2.6 million dollars in creates a sales.
On an underlying basis, excluding creates a sales. This represents 13% year-over-year, Revenue growth for gel Mido driven by both price favorability and volume growth.
R&D expenses for the third quarter of 2025, were 14 million, including non-cash, share-based compensation, expense of 0.7 million.
This compares to 11.4 million, including non-cash, share-based compensation, expense of 0.6 million for the same period in 2024.
the increase in R&D expenses of 2.6 million was primarily driven by costs associated with the phase 3, Utopia trial for ugn 103,
Partially offset by lower clinical trial costs, manufacturing costs.
And Regulatory expenses in connection with the story.
So selling General and administrative expenses for the third quarter of 2025 were 37.6 million including non-cash, share-based compensation expense of 2.3 million
This compares to 28.9 million, including non-cash, share-based compensation expense of 2.9 Million for the same period in 2024.
The year-over-year increase of 8.7 million was primarily driven by the story commercial, preparation activities, as well as an increase in overall commercial operation costs.
Including the expansion of the sales force.
Non-cash financing expense related to the prepaid Ford obligation, the rtw Investments of 4.6 million in the third quarter of 2025 compared to 5.9 million in the same period in 2024.
Interest expense related to the term loan facility with funds managed by Pharma account, advisors was 3.4 million in the third quarter of 2025 compared to 2.7 million in the same period in 2024.
The increase was primarily driven by interest expense related to the third challenge of the loan that was funded in September 2024.
Net loss was $33.33 million, or 69 cents per basic and diluted share, in the third quarter of 2025, compared to a net loss of $23.7 million, or 51 cents per basic and diluted share, in the same period in 2024.
As of September 30th 2025 cash, cash. Cash, equivalents and marketable, securities total 127.4 million.
Turning out the guidance. We are providing Revenue guidance for Joe Mo. Only at this point, we continue to expect 2025 Joe Mido. Net product revenues, to be in the range of 94 to 98 million.
This implies year-over-year growth of approximately 8 to 12% over the 87.4 million in demand-driven, gelato sales in 2024.
This excludes the million dollars and creates actual sales reported in 2024.
Guidance on full-year 2025 operating expenses is also unchanged and is expected to be in the range of $215 million to $225 million, including non-cash, share-based compensation expense of $11 million to $14 million.
I'll now turn it back to Liz for summary remarks.
I want to take a moment to acknowledge that this error for Urgent is the result of many years of hard work in a challenging environment. The company was founded for this exact moment to deliver a better option for patients with bladder cancer, and we believe we can deliver that promise.
The journey has not been easy. But we have demonstrated unprecedented clinical results. Where no other FDA approved, treatments exist.
We are creating A New Path and opportunity for patients and it would not be possible without the Urgent team and for them I am grateful.
We believe We will deliver on our commitment for sustainable and meaningful growth and the creation of shareholder value with that, we can open the call to Q&A.
Thank you, ladies and gentlemen, if you have a question or a comment at this time, please press star 1, 1 on your telephone. If your question has been answered, you wish to remove yourself from the queue? Please press star. 1. 1 again, we will pause for a moment while we compile, our Q&A roster.
Our first question comes from Tara brofft with TD, cow, and your line is open.
Hi, good morning, everyone. So my question is, um, I'm hoping you can maybe explain for us a little more specifics on the timing that you mentioned regarding revenue recording. I know, I know you stated previously that there’s a 45 to 60-day time to treatment and then a similar time to remittance. Um, but I'd really love to hear more on, you know, the actual timing that you observed in real time. Like, did it end up on the longer end of those ranges or even longer? And, especially for the remittance time, you know, where that ended up and then any outlook on how you think that timing in Q4 could play out, um, if that should stay consistent until the permanent J Code or not. Thank you so much. Yeah. Great, Tara. Hi. Um, thanks for the question, and I'll ask David to sort of, you know, give you more information about, you know, why the 45 to 60 days, what we're actually seeing, and then, you know, how we expect that to evolve over time? So, David.
toward a much smoother path in terms of time to treating the first uh, time to First dose
And then I think on your second question on remittance. Um, we have paid claims now and, uh, on average, I think what we have experienced from, in terms of what our practices, our customers have told us is that it does take a little longer during the miscellaneous J code. And, uh, so that's playing out as we've as we anticipated. Thanks for the question. Um, yeah, I guess so, only other thing. David was the, um, how do we expect it to be in Q4? And then going into q1? Yeah. Thank you. Liz. Um, we expect the same Dynamic to play out through Q4 Tara and, um, as we turn the corner into to the first half of, uh, 2026, much of that Dynamic will, um, start to wane, but it'll take some time. Um, but we do see gradual Improvement across all those measures during the first half of 26.
Okay, very helpful. Thank you so much.
1 moment for our next question.
Our next question comes from Michael Schmidt with. Uh, Guggenheim, your line is open.
Hey, good morning. Uh, it's Paul on for Michael, thanks for taking our question. For this Zuri, I just wondering how much visibility you have into Physicians, who are waiting for the permanent J code to kick in on January 1st, to begin submitting. Those patient enrollment forms. Are there any qualitative metrics, you can share on on feedback from those docs? Or is there a way to quantify the sort of kind of demand that's made?
Being held up until the J code is effective.
Yeah, great question. Uh, Paul. So I was just David to comment and may may add some commentary myself at the end, but David, yeah, thanks for the question. Um, we do hear from quite a few Physicians, particularly in the community setting, um, that they are interested in prescribing, the story of identified patients, uh, but really want to wait until January um,
Until the permanent J code is in effect. So that's been
encouraging in terms of understanding the demand and also having the transparency from the customers as to when they anticipate starting. So we're going to do everything we can during the fourth quarter to make sure they are set up so that uh, all they need to do is really activate the patient enrollment form, come January 1st. Uh but it is uh really encouraging what we're seeing so far.
My personal experience, uh, going out to the field and talking, uh, to doctors to practice managers and, you know, 1 of the things that David mentioned around administrative approvals. I think we're seeing more of that. Now, that you've seen the consolidation and private Equity, you've seen the buyout of, um, you know, from Cardinals. So we are seeing more sort of top down, uh, where the, you know, practice is saying, no, you can't prescribe it prior to uh, getting a J Code. So I I think um, my experience anecdotally is that more Physicians than not and
More practices than not or waiting, which is, which is why we have this a good outlook for what we expect to see, you know, going into 2026 because they, um, you know, they have all identified patients but have just made it very clear for several reasons that they will not prescribe until, um, you know, until they see a j code to your point about quantifying that. Um, what I can say is that the team has a list, right? We haven't Quantified that but we have a list, um, and to David's Point, uh, our our top priority is pulling through our patient, enrollment forms, right? And getting pnt committees, that's our number 1 objective. But the second objective is, ensuring that all of those patients and Physicians who have said to us, I have patients identified. And once we get into the new year, I will prescribe with a permanent J code to Davis point. We're making sure that they're ready to go as quickly as they can be.
Um, when we do get to the new year, so that's our second priority. But priority number 1 is, you know, we have a lot of pests, as we've said many times the the top of the funnel is actually very strong and um, it's just our ability to pull it through and um, so that's got to be our number 1 objective and um so uh so hopefully that helps Paul and, you know, to provide some extra color.
Great, thank you very much.
1 moment for our next question.
Our next question comes from Kelsey Goodwin with Piper Sandler. Your line is open.
Effective. Um, and then, secondly, we've gotten a couple questions specifically on the wording of demand Revenue estimate. I guess that 4.5 million figure is that the actual sales estimate for October or the implied demand, you know, 45 to 60 days later. Thank you.
Giving you that would actually it's not implied. It's not like 45 to 60 days later. Um, that you know. But but but a great question, um, so I'll ask David to sort of, uh, you know, um, answer your first question. Yeah. On your question around. Um, the trend of enrollments we are seeing very steady, demand, uh, or steady growth in enrollment forms month over month. And, uh, while we're really in the second full quarter of the launch, um, early signs are that we are seeing that uh,
Average per week continue to go up so we're very encouraged by that demand. Um and as we mentioned, you know we're at that point where
On some weeks, we are actually equal to, or greater than Joe mitos. So it gives you a sense that we're, uh, Crossing an inflection barrier there.
Those, you know, there's always a a conversion rate, um, and we see that on just still John Mido today. You're not, you're never going to get 100% of those, but, but Kelsey to say it's healthy is a, you know, is is um,
You know, I, I think it's very healthy and so feel really good, which is why we feel very good about the Outlook. If the patient enrollment forms weren't there, that's showing clear demand, because of patient has been identified.
Perfect. Thanks so much and congrats again.
Thank you.
1 moment for our next question.
Our next question comes from Ruger Robin Salvage with AC Rain. Your line is open.
Thanks very much for taking my question. Um, firstly I just wanted to drill down a little bit further on what you expect the granular quantitative impact of the J code to be, you know, as soon as it comes online. And in particular, if you could comment on what you anticipate, the reduction in lag time between the receipt of the patient enrollment form relative to actual patient dosing, uh, could be once the job takes effect. In other words, you know, with the active J Code, you know, will the lag time be reduced from 45 to 60 days to under 30 days? Or, you know, do you do you have more granular sense of what the impact of the J code? Is going to have on that time frame and then my second question is related to ugn 103. I was just wondering if you could give us some additional granularity on what the FDA is likely to consider.
Sufficient longitudinal clinical data, including but not limited to the, uh,
Sustained complete response rate achieved in the Utopia trial for you to be able to file for approval of the product. So, obviously, you've announced a 3-month data. We just want to know, uh, how much additional long-term sustained complete response data and any other efficacy parameters, you will need to furnish in order to be in position to file the ugn 103 NDA. Thank you.
Yeah, thanks.
David to answer the first question then Mark will comment on um the FDA.
So I can order the product and that they're trained. And then, of course, as Liz mentioned earlier on, we want to make sure that they have permission. So while Physicians are, um, interested in using it, they have to make sure that they have permission whether it's in the hospital setting or in their practice. All of those things will improve over time. Particularly as you as a, as a practice treats, a patient. Um, and they're on to the second patient. So you can imagine a lot of that starts to ease. So, um, we do anticipate steady Improvement in terms of the time to new patients start. Uh, it will be gradual, it will not be a overnight sensation, it'll just be, uh, something that we continue to work through, but the key to that is going as you go to a practice and you get deeper into, um, into the practice where they're treating more than 1 patient, a lot of that becomes, much more standardized and uh they're not doing it for the first time. Uh, the other question you had um was around just
The other component around J code.
It makes it a lot simpler for the, um, for the office. Remember that during the miscellaneous J Code, period. The primary thing that uh, practices have to deal with is that they're doing a manual claim submission and it takes on average about 2x, uh, the time to Ribbons as it would be when they have a permanent J Code. So once we have uh, turned the corner into 2026, um, the claim submissions are going to be electronic and then the remittance will be considerably faster that should, uh, increase their confidence in terms of reimbursement. And then when you add that to the overall operation,
Readiness that we will have. We do anticipate that overall adoption can accelerate. And then the final point I'll make is regarding our comments.
We have been actively setting up the sites of care, and that just means while they may not have treated the patient, they are operationally ready to order the story. And so, because we got out ahead of that, we realized that's going to be important for the first half of 2026. We do feel good that we're laying a good foundation in terms of supporting broader adoption.
Yeah, the only thing that I'll add to that.
Right now.
Right from, uh, you know, depending on the patient. So we expect to get similarly there. Um, but I do agree with David that it's not going to happen January 1st, right? He doesn't, it's not a, it's not a flip of a switch because the J code is just 1 component of, um, of what, you know, why it takes the 45 to 60 days. So you'll see that improve over time, but but it will take some time to get there and we will eventually get below, you know, below, uh, 30 days. So Mark maybe comment on the 103. Yeah. Uh, Ron thanks for the question. So our expectation is as we've previously announced
Publicly that we'd submit in 26 with expectation of approval in 27 and will our our, our experience of the FDA and The Envision trial suggests that ultimately they're going to want to preponderance and follow-up data around 12 months. So we would submit. And then as we have done previously in a number of applications update during the uh submission process. So that's probably what we'd be looking at with um, with 103 as well.
Thank you. 1 moment for our next question.
Our next question comes from Paul Choi with the government's actual line is open.
Hi, uh, good morning everyone. Thanks for taking our questions. Um, along a similar line. I want to ask, uh, do you think you can get the time between the enrollment form, to to revenue recognition down to where, uh, Joe Mido currently is in the time frame of 2026 or will that be something that will take a little longer any color on on that would would be helpful. Um, and my second question is, um, as we look at your cash position and and your, uh, net loss for the quarter. Can you comment on whether you you feel like you uh you'll need additional capital in 26, just at the current run rate or are you assuming, uh, either the revenue side or or the cost savings side? So we'll be sufficient to to transition you to, to profitability relative to your your current cash position. Thank you very much.
Yeah, um, um, thanks Paul. Um, you know, we can David can answer the first question and then turn it over to Chris to, uh, talk about the CAS position. So David, hi Paul. In terms of your question around getting the, uh, time to new patient starts, um, equal to that of Joe Mido, one of the things we’ll be tracking very closely and we’re putting in a lot of extra effort, obviously to accelerate. Um, but we do anticipate that over the course of 2026, those, uh, those times to new patient starts will converge exactly. It’s hard to say exactly when that will be, but the key is we understand the components of that. And so we have a very deliberate plan and actions to actually, um, do everything we can to shorten each component of that time from Pep to new patient start.
Okay great. Thanks. Liz.
And then Paul on cash. So you saw, you know, we have a little over 127 million in cash. So, you know, we're well, positioned to be able to, you know, deliver,
On our core priorities. There's a story launch. And, and with the expectations around Revenue growth, you know, and based off our current operational plan, you know, we continue to believe that we do have cash to profitability. Uh, but you know, we will continue and remain disciplined in terms of how we think about and be opportunistic, you know, future Capital needs.
Okay, thank you.
1 moment for our next question.
Our next question comes from Leland gershel with Oppenheimer. Your line is open.
Thank you for this update and for taking our questions, um, you know, for David wondering, if you could share with us, I know it's early days and and, you know, the J code dynamic. Um, but as you've progressed and as history, early launch, um, could you comment on on kind of the ratio of, you know, Community uptake versus institution? And it was a fair to say that that Community. Um, practitioners are really still waiting for the J code, and there's been minimal contribution um, to demand from Community, or has there been sort of a somewhat of a rise in community demand as you progressed in the first. Um, couple quarters. Thank you.
Hey everyone, thanks for the question. Um, you know, launched a date. We're seeing approximately 35 to 40% of our patients, treated in the community and roughly 60 65 in the hospital setting, um, as we have outlined even prior to launch, um, a lot of the hcps are going to find it advantageous to treat in a hospital outpatient setting, just because of the economics. Um, but we're very encouraged that the interest level in the community practice uh, among those who are willing to treat right now and also with those who have indicated a sincere desire to treat, come January 1st. So hopefully that gives you a little bit of color but 1 of the things I'll say is as we turn the corner into 2026 as the permanent J code is in effect. We do anticipate the proportion of community physicians to steadily increase over the course of the year into the into the out years.
Thanks and again, early early days. But um, I'm not sure if you, I don't think you could comment on this in the prepared remarks. But can you just give us some color on what the overlap is, uh, and historical, John Mido users and their interest in just dirty versus what maybe, um, you know, untapped previously untapped neurologists and um, they are interested in the story. Thank you.
Yeah, I think um with gel Mido um he was a little bit heavier in the institution um and today with John Mido it's probably half half 50/50 and so that gives you a sense. We do expect though because the patient population for lgir nmibc patients is largely seen in the community practices. We we do expect like I said to continue to see more uptake in that Community setting.
No. But I think what he's asking is, um, John of the John might there's a story people are using their story. How many of those are? John Mido users, and a lot of them are Leyland. So, a lot of our initial usage of this story has been with John Mido users. The good news is, is that we also are seeing some new Physicians using, uh, John Mido. Because because we're going in to talk about the story. So, as we've talked about before, with the expansion of the sales organization, we're seeing more doctors, and we have seen this reverse Halo start to, um, generate some demand for some Mido that we, um, in positions that hadn't seen them before. So, to your point, the absolutely, you know, some of our first prescribers have been John Mido users, but not all of them, but definitely, you know, definitely those familiar with John Mido. And we expect, um, you know, that uh, to continue in the Halo to continue into 2026.
All right, thank you both.
1 moment from our next question.
Our next question comes from Aiden housing off with ladenburg. Your line is open.
Hi. Thanks so much for taking our questions. Um I got couple. So could you remind us how long it usually takes for for a patient to schedule a repetitive T surgery? And if those are the same urologist, do you think they have more financial incentives to run another T surgery or administer the story?
Great. Great question.
Yeah, thanks for the question in terms of scheduling, a to RBT what we generally hear from our customers, is it takes them 4 to 6 weeks to actually schedule 1. So, um,
Administers a story. It can be roughly right now. Um they've got to schedule the patient in but it again it's basically it's based on the patient's desire uh and their schedules from a financial perspective. Um 1 of the things that we'll think about is a patient, a physician's fee uh for doing a turbt is going to be in a couple of hundred dollar range. Um and that is excluding any sort of fee for the actual hospital. Um, and 1 of the things that we have been asked a lot in terms of the financial um, economics of the story that our Market access team can speak to is that um there is ability to be positive from administering the story. So and then importantly because it can be done by a nurse. It does allow the urologist to actually attend to other matters. So hopefully that gives you a little color in terms of the uh the time to schedule and also the economics.
Thank you, very helpful. And another question I have on UroGen, 501, uh, next generation on collecting virus. So can you help us understand the competitive landscape for UroGen and 501? And what are the possible parallels with, uh, with the CG oncologist story?
Um, so thank you. Uh, it is, uh, analogous at least in terms of the type of asset and the meccan, the the purported mechanism of action. Uh, that the CG asset. Um, utilizes in its uh effect on BCG refractory, um, carcinoma and Saito and Associated papillary disease. So, this is This falls into the asset class of developed for high-grade disease, high-grade, non-muslim Mason cancer. The thing about the 501 asset to keep in mind, although obviously, we are in IND enabling stage and anticipate Phase 1. Uh, in 26, is based on what we know about this. Highly very specifically engineered virus. It has very specific replication advantages in terms of its potency, its replication speed and also its ability to affect both primary tumor cell, license and an adjunctive anti-tumor immune response.
So it would be unfair at this stage to directly compare this asset to the CG asset. It's a similar class, we think it is a very, very potent and very promising molecule and just to close. Remember this is an asset that we are going to be primarily developing in the context of treating patients with non-muslim invasive, bladder cancer, starting with high grade disease, but we also believe that it will have application Beyond Urologic oncology. And we are having internal conversations about the development of that, uh, plan as well. So,
Something for the future to think about.
Thank you very helpful.
And I'm not showing any further questions at this time. I'd like to turn the call back over to the list for any further remarks.
Right. Thank you. I just want to take the opportunity to say thank you to everybody on the call for joining. Um hopefully we've got um a lot of things to look forward to over the next few months. As we continue to accelerate adoption was this Dury, you know, deliver on John Mido revenue and importantly, Advance our pipeline. So again, thanks thanks everybody for joining and we look forward to keeping you guys a breast. Thanks.
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