UroGen Pharma Q4 2023 Earnings Call Transcript

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March 14, 2024

There are 11 speakers on the call.

Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the UroGen Pharma Full Year 2023 Earnings Call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vincent Perron, Head of Investor Relations. You may begin.

Speaker 1

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's full year 2023 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 year ended December 31, 2023. The press release can be accessed on the Investors portion of our website at investors. Eurogen.com.

Speaker 1

Joining me on the call today are Liz Barrett, President and Chief Executive Officer Doctor. Mark Schoenberg, Chief Medical Officer Jeff Bova, Chief Commercial Officer and Don Kim, Chief Financial Officer. During today's call, we will be making certain forward looking statements. These may include statements regarding our ongoing commercialization activities related to gelmato, our ongoing and planned clinical trials, commercial

Speaker 2

and clinical milestones,

Speaker 1

market and revenue projections and opportunities, our commercialization strategy and expectation as well as potential future commercialization activities for UGN-one hundred and two if approved anticipated data, regulatory filings and decisions including UGN-one hundred and two potentially receiving priority review, UGN-one hundred and two being transformative and the major growth driver for your agenda for proof, future research and development efforts for UGN-one hundred and three, UGN-one hundred and four and UGN-three zero one, our corporate goals and 2024 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 EuroGen disclaims any obligation to update these statements. I will now turn the call over to Liz.

Speaker 1

Liz?

Speaker 3

Thanks, Vincent, and thank you to everyone joining us this morning. 2023 was a very successful year for UroGen, laying the groundwork for progress and growth in the years ahead. The Phase 3 ATLAS and ENVISION trials evaluating our lead development candidate, UGN-one hundred and two, both met their primary endpoints. The data underscore the potential of UGM-one hundred and two to be a transformational product and to advance the standard of care and low grade intermediate risk non muscle invasive bladder cancer. We have started the regulatory submission process and believe that if approved, UGM-one hundred and two will be the major growth driver for our company.

Speaker 3

We see a great opportunity to improve the lives of patients and create value for our stakeholders. Meanwhile, our existing commercial product, Jommeida, continues to enjoy double digit growth and positive adoption trends. The current clinical development plan for UGM-one hundred and two was agreed with the FDA in a pre NDA meeting that was held in late 2023. The FDA confirmed that the current clinical development plan for UGN-one hundred and two, which includes evaluation of duration of complete response data at 12 months from the pivotal ENVISION trial, will support submission of an NDA for the treatment of low grade intermediate risk non muscle invasive bladder cancer. We announced in January this year that we had submitted the chemistry manufacturing and controls, or CMC modules of this application.

Speaker 3

The objective of a rolling NDA is to facilitate early engagement with the agency and potentially allow for more efficient and timely review of the application. We plan to share the data on the duration of response endpoint from Envision in June of this year. Assuming the data is as expected, we will complete submission of the NDA late in Q3. If granted priority review, we anticipate approval and launch of UGN-one hundred and two as early as the Q1 of 2025. The commercial opportunity in low grade intermediate risk non muscle invasive bladder cancer is significant.

Speaker 3

We estimate that approximately 82,000 patients are eligible each year in the U. S. So the overall market is around 10x the size of the urothelial carcinoma market that JALMIDO currently addresses. This translates into a total market in excess of $3,000,000,000 and over a $1,000,000,000 revenue opportunity for UGM-one hundred and two when using conservative assumptions. We also announced in January that we entered into a strategic license and supply agreement with MEDAC to develop next generation novel mitomycin based RTGel formulations of JALMIDO and UGN-one hundred and two.

Speaker 3

Through this agreement, we are combining our proprietary RTGel with Medac's proprietary formulation of mitomycin. Our next generation products are anticipated to provide advantages in terms of production, manufacturing efficiency, supply and product convenience. Importantly, the program could provide additional patent protection for our urothelial cancer franchise. MEDAC has issued IP with protection expected to last until 2,035 and UroGen has separate pending U. S.

Speaker 3

Patent applications that if granted could provide protection until December of 2,041. We will need to conduct clinical endpoint studies to support NDAs for UGN-one hundred and three and for UGN-one hundred and four, our next generation formulation of JALMIDO. Importantly, this will be a smaller development program and we intend to move directly into Phase 3 for both products beginning in 2024. Turning to JALMIDA revenue, the product achieved sales of $23,500,000 in Q4 $82,700,000 for the full year 2023. Reflected in this number are some non patient sales.

Speaker 3

We have also seen an increase in gross to net deductions. But most importantly, patient demand drivers remain strong with patient enrollment forms, new patient starts and doses, all achieving approximately 25% growth for the year. Jeff will provide additional details in a few minutes. As we look toward long term growth, it is critical that we maintain a strong balance sheet and the ability to expand our patient impact through life cycle management and development of new medicines to treat urothelial and specialty cancers. We are pleased to announce our expanded partnership with Pharmakon Advisors, providing us with additional funding of up to $100,000,000 As part of the agreement, we are required to draw down on the first tranche of $25,000,000 by September 30, with the option to draw up to an additional $75,000,000 dollars following UGN-one hundred and two approval if needed.

Speaker 3

The benefits of this agreement are that we now have an additional source of capital with flexibility on the amount we utilize. We have enjoyed a productive and collaborative partnership with Pharmakon Advisors and look forward to closely working with them in the future. With our current cash balance and approximately 25,000,000 dollars recently sourced from the ATM, we expect to have the capital to execute a comprehensive launch for UGM-one hundred and two, if approved, and fund new potential clinical studies. I will now turn the call over to Mark Schomburg, our Chief Commercial Officer. Mark?

Speaker 4

Thank you, Liz. We had the opportunity to share the Phase 3 ATLAS and ENVISION data with the physician community at the Society of Urologic Oncology Annual Meeting, which took place in November. We were especially pleased that the SCO selected the ENVISION data as one of only 2 late breaking trials that were designated for oral presentation at this meeting. Looking at the body of clinical data we have generated, UGN-one hundred and two has demonstrated consistency in the 3 month complete response rate across ATLAS and VISION as well as our prior Phase 2b OPTIMATE 2 study. The complete response rates observed in these three studies were 65%, 79% and 65%, respectively.

Speaker 4

Moreover, ATLAS data suggest UGN-one hundred and two appears to be superior to surgery once the complete response has been achieved. In the ATLAS study, 80% of patients who received UGN-one hundred and two experienced the duration of response of 12 months, compared to only 68% of those patients who had a TURBT alone. We believe that the ability of UGN-one hundred and two to achieve high complete response rates non surgically and to potentially extend disease free living will ultimately minimize the need for multiple surgeries in this patient population. The average age for diagnosis of bladder cancer is in the mid-70s. Many of these patients have comorbidities that highlight the need for non surgical treatment alternatives to the contemporary standard of care, TURBT.

Speaker 4

UGM-one hundred and two has the unique advantage of being easy to administer. Patients can be treated in their urologist office without the need of an OR and all the disruption to daily life associated with surgery. As Liz mentioned, the next milestone in this program will be the secondary endpoint of 12 month duration of response data from ENVISION. Different from the ATLAS data, ENVISION consisted solely of recurrent patients that had received at least 1 TURBT. If we look at the comparable subgroup of recurrent patients in ATLAS, the 12 month duration of response was 66%.

Speaker 4

The Phase 2b OPTIMA study projected a 12 month duration of response in the high 50s. As we have consistently communicated, we expect the ENVISION data to show a duration of response at 12 months that is 50% or higher, and we believe this is clinically meaningful and will be an improvement over the current standard of care. Importantly, in patient interviews conducted during the EMEVISION trial, patients overwhelmingly preferred UGN-one hundred and two and said they would recommend it to other patients, highlighting the lack of disruption to daily life and that UGN-one hundred and two was less invasive, less painful and less time consuming than the standard of care. If approved, UGN-one hundred and two will be the 1st and only non surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries. Beyond our lead programs, we continue to advance our immuno oncology candidate, UGN-three zero one into the clinic.

Speaker 4

UGN-three zero one is comprised of an anti CTLA-four antibody delivered using our proprietary RTGel technology. We are conducting a Phase 1 clinical study to evaluate the safety, tolerability and establish a recommended Phase 2 dose for UGN-three zero one as monotherapy and in combination with other agents. Safety and tolerability data for the monotherapy arm are expected in mid-twenty 24. We have also initiated combination therapy arms evaluating UGN-three zero one plus gemcitabine and UGN-three zero one plus UGN-two zero one, our proprietary formulation of the eniquimod, a TLR7 agonist in high grade NMIBC patients. We believe we have a unique approach in this area and look forward to providing updates on this trial as it moves forward.

Speaker 4

Finally, as Liz mentioned at the beginning of the call, we are pushing ahead with next generation formulations of our upper tract and bladder products for low grade urothelial cancers. We look forward to commencing Phase 3 efforts for both drugs, UGN-one hundred and three for the bladder and UGN-one hundred and four for the upper tract soon, and we'll keep you posted as those clinical programs advance. With that, I will turn the call over to Jeff Boba to provide a commercial update.

Speaker 5

Jeff? Thank you, Mark. Jelmito sales, as Liz mentioned, were $23,500,000 $82,700,000 for the Q4 and full year 2023, respectively. Demand remains strong in 2023. Despite achieving our targeted unit sales, the value of each unit was lower than anticipated, primarily due to gross to net erosion driven by higher than forecasted 340 rebates and estimated Medicare refunds for discarded drug, offset by non patient sales.

Speaker 5

We are providing guidance for 2024 for the first time today and are forecasting full year Joe Mito net revenues to be in the range of $95,000,000 to $102,000,000 While slightly lower than consensus, this reflects continued growth to net erosion despite anticipated continuing double digit patient growth. Don will provide additional detail on our guidance in a few minutes. It is important to note that the CMS discarded drug provision will not impact UGN-one hundred and two as the bladder allows for installation without waste. Additionally, UGN-one hundred and two will be less sensitive to 340B since it will primarily be administered in the doctor's office. As mentioned in past calls, we've added regional operational managers, which help every facet of the business, particularly operational roles intended to focus on opening new accounts and preparing them for GelMido use.

Speaker 5

Our data show that territories with the most sites of care are the most successful and this role is instrumental in growing sites of care. There is a growing body of evidence from real world evidence studies that continue to strengthen and reinforce JALMAYDO's value proposition. We have data from over 3 years in the market that reinforce and support the product's efficacy and safety in the real world setting. I am pleased to report 3 abstracts reviewing JELMIDO real world evidence outcomes have been accepted at the upcoming AUA meeting, and our registry will provide additional insight into outcomes with JALMIDO use in the real world setting. For UGN-one hundred and two, we are now executing our pre commercialization plan in preparation for prospective launch in early 2025.

Speaker 5

This includes engaging with urologists and patient advocacy groups. There is approximately 95% overlap in the prescriber base with Yalmaya, which allows us to leverage our existing commercial organization. Our research tells us physicians are concerned with the high rate of recurrence in many other patients who often experience limited intervals between TURBTs. They're seeking strategies to prolong or extend the interval between recurrences as these patients don't get much of a break between the TURBTs. The literature shows that complete response rates for surgery at 3 months are in the range of 40% to 70%.

Speaker 5

Our understanding of bladder cancer is that the underlying pathology of this disease is not always visible to the surgeon. Normal appearing cells in the bladder may contain genetic abnormalities that will give rise to disease recurrence. UGN-one hundred and two treats the disease in a way that permits us to not only treat the visible lesions, but also that background pathology. And we believe that's why we achieve better long term disease control and longer disease free intervals than the current standard of care in our ATLAS study. We are also considering the economics of how bladder cancer is treated.

Speaker 5

There's a misconception that surgeons generate a lot of income from TURBT. The reality is that while overall costs of the surgery are quite high, surgeons are only paid a few $100 per operation. Given the potential for better outcomes with UGN-one hundred and two, we do not expect practice economics to be a barrier to adoption. Based on our market research, we believe the fastest adoption for UGN-one hundred and two would initially occur in 3 groups of patients. They are patients who have had multiple recurrences, those who would be considered surgical failures, patients with early recurrence, and finally, patients who are ineligible or unwilling to undergo surgery.

Speaker 5

We are confident that as physicians gain experience in these early groups, UGN-one hundred and two will quickly expand to all recurrent patients if approved. We look forward to providing additional insight into our plans as the year progresses. I will now turn the call over to Don Kim to discuss our financials.

Speaker 2

Thank you, Jeff. Revenues for the Q4 of 2023 were $23,500,000 compared to $18,100,000 in the comparable period in 2022. Revenues for the full year ended December 31, 2023 were $82,700,000 compared to $64,400,000 in 2022. Cost of revenues for the Q4 and full year 2023 were $2,300,000 $9,400,000 respectively, compared to $2,300,000 $7,700,000 respectively, for the Q4 and full year 2022. The overall increase of 1 point $7,000,000 year over year was primarily due to the increased volume of Gem Mitra sales.

Speaker 2

R and D expenses were $11,300,000 $45,600,000 respectively, for the Q4 and full year 2023, compared with $14,500,000 $52,900,000 respectively for the comparable period in 2022. The decrease in R and D expenses year over year is primarily attributable to lower research and development expenses due to the conclusion of ATLAS trial, lower cost related to Phase 3 ENVISION trial for UGN-one hundred and two and the ending of our collaboration with MD Anderson, partially offset by higher R and D expenses related to our Phase I study for UGN-three zero one, cost incurred related to research into ingredient scale up and production for UGN-one hundred and two and clinical compensation expenses. SG and SG and A expenses were $24,600,000 $93,300,000 respectively for the Q4 and full year 2023 compared with $21,600,000 $82,800,000 for the Q4 and full year 2022. The increase year over year was a result of increase in brand marketing and general commercial expenses as well as increase in compensation expenses, 3rd party advisory providers, recruiting fees, certain media and meeting expenses and ongoing managed services. These were partially offset by lower commercial back office services and support expenses.

Speaker 2

Interest expense was $3,600,000 $14,700,000 respectively for the 4th quarter and full year 2023, compared with $3,200,000 $8,400,000 respectively, for the Q4 and full year 2022. The cost for the full year 2023 relates to interest expense on the Pharmakon loan for the full quarters versus the prior year given the funding of the first tranche and second tranche of the Pharmakon loan was in March 2022 and in December 2022, respectively. In addition, the increase year over year was attributable to increase in interest rates related to the Pharmakon loan. Net loss was $26,000,000 or $0.72 per share and $102,200,000 or $3.55 per share for the Q4 and full year 2023. This compares with net losses of $28,900,000 or $1.25 per share and $109,800,000 or $4.81 per share for the Q4 and full year 2022.

Speaker 2

EuroGen has $141,500,000 in cash and cash equivalents and marketable securities at December 31, 2023. Based on our latest financial forecast, we believe our current cash position and resources and projected revenue will support our commercial organization through the potential launch of UGN-one hundred and two in early 2025. Switching now to 2024 full year guidance. We anticipate full year 2024 JLMiCER net revenues to be in the range of $95,000,000 to $102,000,000 Full year operating expense is expected to be in the range of $175,000,000 to $185,000,000 including non cash share based compensation expense of $6,000,000 to $11,000,000 subject to market conditions. We'll continue to scrutinize all expenses in support of our efforts to prioritize cash preservation.

Speaker 2

Financing expense related to the prepaid forward obligation to RTW Investments is expected to be in the range of $21,000,000 to $26,000,000 of which approximately $12,400,000 dollars to $13,300,000 will be in cash. In addition to RTW financing expense, interest only payments on the $100,000,000 term loan facility with the funds managed by Pharmakon Advisors will continue to be made quarterly and accrue at a rate of adjusted term so far plus 7.25 percent in 20 24. For further details on our financials, please refer to our annual report on Form 10 ks with the SEC. We are now ready to open the call for questions. Operator?

Operator

Our first question will come from the line of Tara Bancroft with TD Cowen.

Speaker 6

Hi, good morning. So I was hoping you could tell us more about what you envision for how the early launch of 102 can look like. I understand there's significant overlap in practice across the two products with DALMIDO. So I was hoping to better understand how you're thinking about commercial synergy and how you expect that to play out in the coming years as 102 launches?

Speaker 3

Yes. Hi, Tara, it's Liz. Thanks for the message and apologize for my voice. I'm kind of overcoming a really bad head cold right now. So I'm going to turn it over to Jeff, but just say to your point, lots of synergy here, but we also want to ensure early significant uptake.

Speaker 3

And so because of that, we are adding resources. But Jeff, can you put more color around exactly what that's going to look like? And I also want to let everybody know that we have Silvio Pacheco is our Vice President of Market Access join the call as well in case there were anyone wanted more details around the wastage provision or the gross to net. But Jeff, why don't you answer the question?

Speaker 5

Sure. Hi, Tara. So I have said in the past, we look to expand 1 to 2 regions. I feel comfortable now confirming we will expand a region and roughly go from 45 to 60 TBMs. Two main drivers there is obviously with 45 territories, you have some significant geography.

Speaker 5

So we would increase the efficiency there with those TBMs. And then the other is there are a lot of more physicians that really do specialize in bladder cancer. As opposed to upper track, not a lot of urologists really do a significant number of upper track, quite contrary with bladder, there are more urologists that specialize in bladder and we want to make sure that we increase and have a significant reach and frequency on those key targets. It's a we talked about the operational difference between 102 and GelMido. We're obviously looking at how to deliver the product.

Speaker 5

I talked to the fact that we may go out with just a mixed product, which will allow for additional convenience. And then the obviously the buy and build portion of this, Silvio is on the call, but we'll prepare for everything ready to get a permanent J code soon thereafter launch. Those three areas that I talked about earlier will be the areas we will certainly focus physician and message on with the goal of obviously then growing into just really any patient that recurs would be a candidate for UGM-one hundred and two.

Speaker 6

Okay. Thanks so much.

Operator

Our next question will come from the line of Leland Gershell with Oppenheimer.

Speaker 7

Hi, good morning. Thanks for taking my questions. 2 from me. First, I guess for Jeff, just wanted to ask a bit more on the 340B related discounting. Is that something which we would expect to see perhaps more of as we get through 2024 and beyond for JALMIDO?

Speaker 7

Or is that kind of a one time dynamic that we do not have as much concern about in terms of its impact on what maybe your 2024 guidance? And if you could also share to what extent is Gilmide have business exposed to 340B? And then I'll have a question for Mark. Thank you.

Speaker 5

Thanks, Leland. Why don't I ask Sylvia to have comment on the 340B and what we saw last year and what we think will continue?

Speaker 8

Leland, yes, thanks for the question. So what I would say is similar to other companies, the impact of 340B is a macro event. And as we all know that the program, the 340B program continues to expand in the marketplace and continues to be a challenge for manufacturers. It is at this point, we closely monitor what potentially the impact may be. And we'll certainly continue to see how we forecast for that in the future.

Speaker 8

What I would like to say though is, as we start thinking about UGN-one hundred and two, as Jeff mentioned, we anticipate that the adoption of UGN-one hundred and two will be primarily in the community space of private practice, and therefore will not have as much of an impact or be impacted as much by the 340B program.

Speaker 3

And Silvio, just to answer his question, I think we feel like we don't expect it to continue to grow Leland significantly versus where we are. But so I just want to make sure that, that's sort of obviously, there may be some risk, but we projected for the year a little bit of erosion, but very minor compared to the past. So as Silvio said, it's every company is probably, in my view, it's the biggest challenge we have as an industry is 340B discounts. And but I think we're in a stable a more stable position now over the last couple of years.

Speaker 7

Thanks, Liz. That's all very helpful. And then Mark, just wanted to ask you, obviously, NMIDC, highly recurrent disease and given the level of recurrence, it could be pretty strong use of 102 as a different near option than TURBT. But why don't you ask about risk of progression from low grade to high grade and even to MIBC. How does that kind of play into urologists' sort of interest and productivity, I guess, in terms of treating patients who have recurrent disease?

Speaker 7

Is there a sort of a time factor as patients recur that there's a increased chance that they will progress and therefore those patients should come in sooner for procedures. Maybe Mark, if you could kind of share us from a medical perspective what the risk of progression beyond what grade is? Thank you.

Speaker 4

Leland, thanks. Sure. It's an interesting clinical question. What we know about this population of intermediate risk with blood gradation is that the fact that a risk progression either at

Speaker 9

a higher rate in invasives

Speaker 4

or even the muscle invasive disease is exceedingly low. In our experience, progression of muscle invasion is 0. So from our own clinical experience at UroGen, that's not something we've observed in lower than the pure allergic risk. We expect that in this population, which is carefully followed in any event. So the likelihood of progression muscle invasion in a near term scenario would be very, very unlikely.

Speaker 4

Change in grade has preserved again, as you've heard Liz and others say on many occasions, our experience in that of others is that this is a chronically relapsing illness, which is why UGN-one hundred and one to take so much sense in the group of patients that they want to surgical resection every time they have a recurrence.

Speaker 7

Okay, thanks. I think I got most of that a little broken up on the connection. But thank you for taking the questions.

Speaker 4

Thanks.

Operator

Our next question will come from the line of Paul Choi with Goldman Sachs.

Speaker 10

Hi, thanks and good morning. Thank you for taking our questions. My first question is for Mark. I think there seems to be some persistent confusion in the market just with regard to follow-up period for Envision here. And could you maybe just again clarify for us what the total follow-up period will be?

Speaker 10

It's 3 months for the installation period followed by 12 months, if my understanding is correct. If you could just confirm that for us.

Speaker 4

Paul, thank you. I hope you can hear me. You are absolutely correct. So when we say 12 months of follow-up, we mean 12 months after the initial evaluation to demonstrate the complete response, which means 3 months to begin trial. So it would be 15 months from the beginning of the study, but 12 months from the primary disease evaluation.

Speaker 4

So you are correct. It's 12 months after that initial 3 months following the completion of the trial, so 15 months into the trial, 12 months following CR.

Speaker 10

Great, perfect. Thanks for clarifying the 15 months of total time. And then my second question is just for both maybe Liz and Don, just with respect to the guidance and cash burn. If we take the median of your midpoint of your revenue guidance and the midpoint of your OpEx guidance and we strip out the non cash items including stock comp as well as the RTW financing expense, we get to a range of roughly $40,000,000 to $45,000,000 in incremental cash burn versus 2023. And I was just wondering if you could clarify how much of that is related to the build out of your sales force that Jeff referenced earlier versus incremental R and D spend for UGN-103 and 104 and just the timing of when that cash burn would potentially accelerate.

Speaker 10

Are we fair correct to assume that it will be primarily back end weighted towards the end of 2024? Thanks so much.

Speaker 3

So I'll let Don give you details. But yes, toward the you're all right, it will be more in the back end. But Don, do you want to give more color around that?

Speaker 2

Yes, absolutely. Thank you, Paul. So basically, this $40,000,000 increase in OpEx, you are correct. And big portion like 25%, 30% of that $40,000,000 increase is actually 1 or 2 commercial product build up. Because before we get the FDA approval, we cannot use this as a cost or our cost.

Speaker 2

So we just use it it expense for inventory buildup. And the other another portion of 50% of this incremental OpEx is obviously the sales force and brand marketing. So as you just mentioned that, yes, it's more of the back end of the year, but it will be incremental cost.

Speaker 3

And there's just minor incremental in R and D because of the with the 103 and 104 trial starting this year.

Speaker 10

Okay, great. That's a lot of helpful detail. Thanks so much for clarifying.

Speaker 3

Thanks, Paul.

Operator

Our next question will come from the line of Matt Kaplan with Ladenburg Thalmann.

Speaker 9

Hey, good morning guys. Thanks for taking the questions. I guess just staying on 102 initially, what's your expected chance for the FDA toward a priority review to the once the filings complete in September?

Speaker 3

Look, you never know, Matt, so we can't guarantee it. But I think there's a lot of things going in our favor. 1, we had a priority review for JALMIDO. 2, assuming the data is consistent, when we see the duration data, the data right now is very compelling. And I think that they the FDA understands the unmet need out there and the need to get these treatments out there.

Speaker 3

So we believe we have a high probability of a priority review, and that's our expectation. So again, you can't say for sure because we won't know until we file and ask for priority review, but we did get the rolling submission that we asked for. We have started that, as you know. And so I think that we felt like we're in a good position to do that.

Speaker 4

Sure, sure.

Speaker 9

Makes sense. And then in terms of after approval, what's your expected ramp of payer coverage for 102? And how should we think about that?

Speaker 3

Yes. Silvio, since you're joined us today, why don't you talk about the payer from a 102 perspective?

Speaker 8

Sure. Matt, thanks for the question. So from a payer coverage perspective, I think there's a couple of elements to consider. One is the inclusion of 102 in the treatment guidelines with the National Comprehensive Cancer Network. And also the application of the J code.

Speaker 8

So the application for a J code happens on a quarterly basis and it is dependent on the FDA approval. So we will work expeditiously to get the J code up and running and we will start engaging payers in the next few months here, providing them with some pre approval information, so they can become aware of UGN-one hundred and two and the clinical value proposition of UGN-one hundred and two.

Speaker 4

Okay. Thank

Speaker 3

you. But Sylvia, if you just comment, we I mean, our expectation, we have over 99% coverage on JALMIDO. We don't expect it to be different for UGN-one hundred and two. We expect significant coverage out of the gates. As you know, about 70% of the population is Medicare.

Speaker 3

And that gets covered because if you get an FDA approval, then Medicare covers it. So we don't really have an issue there. And even with commercial, initially, we won't have a problem and we don't we expect it to be pretty close to where we are with JALMADA, which when I say over 99% coverage.

Speaker 9

Okay, great, great. Thanks. And then just with UGN-one hundred and three and 104, you stated that you plan to start Phase III development for both, but that it would be smaller and more focused studies. Can you give us a little bit more detail in terms of what the regulatory path looks like for both of those? Is it just one study needed for each of them?

Speaker 9

Or how will it work, do you think?

Speaker 3

Yes. What we when we spoke to the FDA about it, they felt like they were different enough that we needed a clinical study. And as we've said in the past, we actually think that's good news because if we have to do it, so will others, right? And that's part of our strategy around any other company trying to come in into our space. So we feel really good about that.

Speaker 3

But what we have discussed with the FDA and we'll continue to align with them is that it needs to show efficacy safety and efficacy and durability, but they want to see results consistent, but we don't have to have the same timeline. So the 102 study will be probably around 85 patients. So if you think about ENVISION at 2 20 patients where we ended up with 240 patients, we only have to do an 85 patient study and something smaller than that for UGN-one hundred and four for the next generation JALMIDO formulation. So maybe in the 50 to 60 patient perspective, we're prioritizing UGN-one hundred and two for obvious reasons from a start perspective and then the follow-up as well. So as long as the results are consistent, then the FDA is open to us filing less data, but just showing consistency.

Speaker 3

And so that's kind of where we are. So our expectation at this point is that we would have approval for both of those in the 2027 time period. So we feel really good about kind of where we are in our ability to get those approved, get the J code for both of them and do an appropriate switch to the new formulation before taking the old formulations off the market.

Operator

That concludes today's question and answer session. I'd like to turn the call back to Liz Barrett for closing remarks.

Speaker 3

Yes. Thanks, and thanks everybody for joining. I think everybody understands that this is a defining year for us at UroGen. We're excited about the prospects and about preparing for UGM-one hundred and two while continuing to increase adoption of gelmitone. We're seeing nice events and nice data coming out of our registry and out of some investigator initiated areas.

Speaker 3

So thanks. We'll keep you guys posted as we as things go along and really always appreciate your interest in our company. Thank you. Operator, you can disconnect now.

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