Good day and thank you for standing by. And welcome to the UroGen Pharma Q4 2022 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there'll be a question-and-answer session. [Operator Instructions] 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. You may begin..

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma’s fourth quarter and year-end 2022 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and preliminary financial results for the quarter ended December 31, 2022.

The press release can be accessed on the Investors portion of our website at investors.urogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; 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 JELMYTO, anticipated seasonality for JELMYTO in 2023, our ongoing and planned clinical trials, commercial and clinical milestones in the year ahead, the potential of UGN-102 to transform the treatment paradigm as the first non-surgical treatment for low-grade intermediate risk non-muscle invasive bladder cancer, market opportunities, potential future commercialization activities for UGN-102 if approved, data presentations, regulatory filings, future research and development efforts, our corporate goals, our optimism regarding multiple avenues available to us to further strengthen our balance sheet and 2023 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 UroGen disclaims any obligation to update these statements. I will now turn the call over to Liz.

Liz?.

Thank you, Vincent and thank you everyone for joining us today. Looking back on 2022, I'm proud of our progress and more enthusiastic than ever about the future of UroGen.

We returned to growth in Q4, delivering our strongest quarter ever for JELMYTO, ending the year with $64.4 million in net product revenues representing a 34% increase from full year 2021. This goes well for UGN-102 as we continue to think of JELMYTO as proof of concept and the gateway for the much larger market of bladder cancer.

That belief is substantiated by the incredible momentum we experience in our UGN-102 clinical trial. In just 20 months, we've enrolled over 500 patients between both the ATLAS and the ENVISION Phase 3 trials.

In fact, we completed enrollment of ENVISION, our pivotal study for UGN-102 for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer in less than a year.

We firmly believe that this has the potential to transform the way urologists treat patients and based on how quickly we enrolled the trial that we have a base of urologists who are eager to elevate their practice. We are planning to provide top line data from both of our Phase 3 studies of UGN-102 midyear.

We will provide an update on complete response and durability in ATLAS, while also providing the primary endpoint of complete response rate in the ENVISION study. Assuming positive results, these studies will form the basis of our FDA submission in 2024 once durability has matured.

UGN-102 is designed to address a much larger patient population and administration is much simpler without the need for fluoroscopy. Therefore, if approved, we anticipate UGN-102 will prove to be our main growth driver in the future.

At the end of last year, we shared long-term follow-up data from the JELMYTO OLYMPUS pivotal trial and the Phase 2b OPTIMA II study of UGN-102. In each of these, we observed a greater than two year median duration of response along with a recently completed small home installation study.

We are optimistic about the upcoming data from ATLAS and ENVISION will further establish the potentially transformative nature of our products. Before turning the call over to my colleagues, I would like to quickly address our balance sheets.

We've now come to better understand the adoption coverage on JELMYTO and expect revenue growth in 2023 to reflect growth of 20% to 30% over 2022 and revenues of $76 million to $86 million.

While we ended the year strong with $100 million in cash, we continue to reduce cash spend and focus on our core assets, especially given the market potential for UGN-102, we're optimistic that we will be in a position to explore multiple avenues to further strengthen our balance sheet when necessary.

Overall, I’m very enthusiastic about the progress we've made in 2022 and the road ahead as we plan for an FDA submission of UGN-102 in 2024. We believe JELMYTO and UGN-102 together represented $1 billion revenue opportunity for UroGen and remain focused on solid execution to turn that belief into a reality.

With that, I'll pass the call over to Mark to further update you on our clinical development program.

Mark?.

Thank you, Liz, and welcome everyone. My comments will underscore Liz's remarks and reinforce our excitement as we advance our lead pipeline program, UGN-102 and highlight recent real world data from JELMYTO. As you may recall, we commenced the international multi-center registrational ENVISION study for UGN-102 in January of 2022.

The study is intended to evaluate the efficacy and safety of UGN-102 as primary chemo ablative therapy in patients with recurrent low- grade intermediate risk, non-muscle invasive bladder cancer. As Liz noted, we expect to report out this data by the end of this summer.

The quickness with which we were able to complete this trial is a testimony to the interest from urologists for a new alternative for treating bladder cancer.

Our confidence in the potential outcome of ENVISION stems from its similarity to the Phase 2 OPTIMA II trial of UGN-102, which demonstrated a 65% CR rate and duration of response at 12 months of 72.5% using Kaplan-Meier analysis. UGN-102 also has key similarities with JELMYTO.

Both products utilize mitomycin allow for local delivery and sustained exposure to mitomycin for up to six hours, and importantly, both low-grade NMIBC and low grade UTUC share many biological and clinical similarities, which leads to common clinical features including the responsiveness to chemotherapy.

UGN-102 however has many important advantages over JELMYTO, which we believe will have a direct impact on its use. It does not require special equipment for procedures and is designed to be instilled in the bladder via urethral catheter in an outpatient setting, a common and routine procedure in most urology practices.

This advantage will be critical as low-grade intermediate-risk NMIBC. It's eight to 10 times more common and a condition that is routinely managed by 80% to 90% of urologists inferring a significantly larger addressable patient population.

We recently shared results from a small study that demonstrated the suitability of UGN-102 installation at home by a visiting nurse under the supervision of a treating physician.

Six of eight or 75% of patients who received six weekly doses of UGN-102 achieved a complete response defined as no detectable disease after three months of starting treatment. Treatment related adverse events were mild to moderate and the few serious adverse events were not treatment related.

We anticipate a small subset of older patients with social challenges may benefit from being treated at home versus in clinic, and the results from this study provide us with added confidence that our novel investigational therapeutic has the potential to address genuine unmet needs for low-grade bladder cancer patients.

In December, we shared new and supportive long-term follow-up data from the OPTIMA II study of UGN-102 at the Annual Society of Urologic Oncology meeting. The study showed a greater than 24 month median duration of response with UGN-102 in 15 of 25 evaluable patients. Long-term follow up data from JELMYTO’s pivotal trial were also presented at SUO.

The study showed a greater than 28 month median duration of response in 16 of 23 evaluable patients. Together, these studies added to the growing body of evidence supporting the potential for long-term recurrence free survival associated with RTGel delivery of mitomycin to the bladder and urinary tract to treat low-grade urothelial cancer.

2023 is shaping up to be an important year for UGN-102 with multiple near-term catalysts, including top line data from the ATLAS trial, the precursor to ENVISION which enrolled 282 patients who completed treatment with either UGN-102 or primary TURBT, top line results from the Phase 3 envisioned trial mid-year and assuming positive results from the Phase 3 trial, preparing for an NDA submission with the FDA in 2024, the goal would be to target priority review, which if granted may potentially result in approval at the end of 2024 or early 2025.

If approved, UGN-102 will be the only primary non-surgical therapy addressing the nearly 80,000 new patients in the U.S. alone who will undergo repetitive endoscopic resection and are burdened with the risks of surgery and anesthesia as their only recourse for disease control. As a practicing neurologist who cares for bladder cancer patients.

This would be a transformative therapeutic advance that I believe will be welcomed by my colleagues and patients alike. Meanwhile, our Phase 1 trial with UGN-301, our in-licensed anti-CTLA-4 antibody for intravesical administration using RTGel technology, continues to enroll.

UGN-301 is in development for the use in combination with other immunomodulators, including UGN-201, our proprietary TLR7 agonist, and other potential chemotherapy and immunotherapies to treat high-grade non-muscle invasive bladder cancer. This study is aimed at identifying the suitable dose for a subsequent Phase 2 trial.

The first arm of this study evaluating dose ranges of UGM-301 as monotherapy is expected to be completed in the second half of 2023. We viewed UGN-301 as a cornerstone checkpoint inhibitor for a variety of potential combination therapies targeting high-grade NMIBC.

In closing, 2023 will be an important year as we look to build upon the foundation of real world evidence and clinical data supporting our increasingly compelling and well established technology and product portfolio of innovative nonsurgical therapies for urothelial cancers.

And with that, I’ll hand the call over to Jeff to provide a commercial update.

Jeff?.

Thank you, Mark. Q4 represented our strongest quarter performance ever for JELMYTO. I’d like to take a moment to highlight a few of the underlying factors which contributed to our performance in the fourth quarter.

Adoption metrics continue to demonstrate encouraging trends in new and repeat accounts, indicating clinical conviction from JELMYTO adopters and growth in new users. Activated sites on March 1, 2023 were 983, compared to 930 on November 1st of last year. And repeat accounts were 214, compared to 177 for the same period.

This is a 21% increase over the last period. Reimbursement remains at approximately 99% across all coverage types. In Q4, we saw strengthening of the JELMYTO ramp and an increase in uptake in several key territories.

This was driven in part by strategic adjustments to our sales strategy discussed last quarter, including the addition of operation support to facilitate logistical efficiencies and alignment of our field sales team with the appropriate drug and device skillset.

We expect the benefits of our revised strategy to deliver sustainable growth in developing territories and are encouraged by the impact seen thus far. Our performance in Q4 also reflects operational efficiencies from the September 2022 label update, which extended the stability period of JELMYTO admixture from eight to 96 hours.

We’ve seen an immediate positive impact to several logistical challenges, including allowing for delivery of the admixture the day before installation, enabling HCP preferred or early morning installation.

This has led to a shift of approximately 50% of doses today prior delivery, facilitating expansion of the geographical coverage of our mixing partners and optimizing our territory business manager’s time in the field. The growing body of outcomes from real world evidence data continues to reinforce JELMYTO’s efficacy and safety.

In addition to supporting a multi-modal approach of JELMYTO across multiple use cases, the recent independent multi-center retrospective analysis has answered a number of questions not addressed by OLYMPUS, arming our commercial organization with a deeper understanding of JELMYTO’s use across various practice patterns.

Further, outcomes from this study add to the growing body of real world data demonstrating a favorable safety profile and additional benefits of integrated administration, which now represents approximately 60% of JELMYTO installations.

After two years of market experience with JELMYTO, we expect to see stability going forward with respect to quarterly variability or seasonal dynamics as we get back to a new sense of normal.

Looking ahead, we expect typical payer dynamics in play in Q1 resulting from deductible resets followed by stronger demand in the second quarter, slight delay in Q3 as we expect PEP conversions to slow in the summer months, followed by a stronger Q4 as PEP conversions return to baseline.

JELMYTO is undeniably gaining traction and adoption appears to be accelerating as the product becomes increasingly proven easier to administer and incorporated across multiple practice patterns.

This reinforces our optimism and lays the foundation for the potentially much larger opportunity with UGN-102 in low-grade, intermediate-risk non-muscle invasive bladder cancer. With 95% overlap in the prescriber base and well-established practice patterns, we expect a seamless integration of UGN-102 into our commercial efforts if approved.

With that, I will turn the call over to Don to discuss our financial results.

Don?.

Thank you, Jeff, and thank you to everyone for joining today’s call. We finished the year with growing momentum delivering our strongest quarter ever for JELMYTO net sales. On an annualized basis, revenue from JELMYTO sales grew 34% in 2022.

For the fourth quarter of 2022, we reported JELMYTO net revenues over $18.1 million, compared to $16.1 million for the same period in 2021. On a full year basis, we delivered JELMYTO net revenues in line with the consensus estimates of $64.4 million, compared to $48 million for the year 2021.

Our performance reflects our strengthening ramp and growing adoption of JELMYTO. For the fourth quarter of 2022, research and development expenses was $14.4 million, as compared to $13.1 million for the prior year quarter. Full year 2022 R&D expenses were $52.9 million as compared to $47.6 million for the full year 2021.

The increase in R&D expenses of $5.3 million is primarily attributable over to higher research and development expenses in 2022 related to Phase 3 ENVISION study for UGN-102, research into ingredients scale-up and production efficiency for JELMYTO, partially offset by lower stock-based compensation expenses in 2022.

Fourth quarter of 2022, selling, general, and administrative expenses were $21.6 million as compared to $21.4 million for the prior year quarter. Full year 2022 selling, general and administrative expenses were $82.9 million as compared to $87.5 million for the full year 2021.

The decrease in SG&A related expenses of $4.6 million, resulted primarily from a decrease in stock-based compensation and compensation related costs in 2022 offset by brand marketing related expenses. For the fourth quarter of 2022, we reported financing expenses related to the prepaid forward obligation to RTW Investments of $5.1 million.

Financing expense related to the prepaid forward obligation to RTW Investments totaled $21.6 million for the full year 2022. The cash payout rate for 2023 will be 13% based on $64.4 million of global net product sales of JELMYTO in 2022. We anticipate full year 2023 JELMYTO net revenues to be in the range of $76 million to $86 million.

Full year operating expense is expected to be in the range of $135 million to $145 million, including non-cash share-based compensation expense of $6 million to $11 million subject to market conditions. We will continue to scrutinize [ph] all expenses in support of our efforts to prioritize cash preservation.

Financing expense related to the prepaid forward obligation to RTW Investments is expected to be in the range of $21 million to $26 million, of which approximately $9.8 million to $11.1 million will be paid in cash.

In addition to RTW financing expense, interest only payments on the $100 million term loan facility with the funds managed by Pharmakon Advisors will be made quarterly and continue to accrue at a rate of LIBOR plus 8.25% in 2023.

We ended the year with $100 million in cash and cash equivalents, which is expected to finance operations into the first half of 2024. To echo Liz, we are committed to diligently and proactively managing our balance sheet in support of our commercial and clinical development activities.

We’ll continue to watch revenues and monitor expenses closely while also routinely evaluating our cash position and capital market environment to the needs to opportunistically strengthen our balance sheet arise. With that, I’d like to turn the call back to Liz for closing remarks..

Thank you, Don. I’d simply like to close by pressing my pride in all that we have accomplished and continue to execute on from the leadership right through to the entire UroGen team.

I’d also like to express my sincere thanks to those individuals as well as to the patients and clinicians that are realizing the benefits of JELMYTO adoption and the diligence of the investigators and patients participating in our ongoing clinical trials. Finally, I’d like to thank and reiterate our commitment to our shareholders.

We see the importance of the goal that we are trying to achieve. We look forward to keeping you all apprised as the important events continue to unfold over the weeks and months ahead. I’ll now turn the call over to the operator for a Q&A session.

Operator?.

And thank you. [Operator Instructions] And one moment for our next question. And our first question comes from Leland Gershell from Oppenheimer. Your line is now open..

Hey, good morning guys. Thanks for taking the questions and congrats on the progress. Two questions for me. First for Mark.

As we’ll wait for the durability data from ENVISION, obviously, early next year after we get the response top line and any reasons we should think that would differ than what we saw – from what we saw in OPTIMA II? And then second question for Liz.

You’ve just teeing off the comment you made about the size of the UGN-102 market opportunity providing potential opportunities to strengthen the balance sheet. Just wondering if that should lead us to think about any sort of development or strategic arrangements you may be contemplating down the road with UGN-102 as you get to commercial? Thanks..

Okay, thanks, Leland. Mark, why don’t you answer and then I’ll come back..

Yes. Sure, Liz. Thanks, Leland. Good morning. So the short answer is no. Just to remind the listeners, in OPTIMA about 25% of the cohorts studied were patients with de novo disease. The remainder of those patients who had recurrent disease. In ENVISION, all patients will have had recurrent disease.

When we evaluated this question as to whether or not there was a difference between new and recurrent responses to UGM-102 in the OPTIMA cohort, we were not able to discern a difference based on that cohort. So our expectation is that in the ENVISION trial, we will see very similar results to what we reported in OPTIMA..

And to answer your question, Leland, I mean, to be honest with you, we’re looking – we are always opportunistically looking at everything. So whether it be BD, a strategic partnership, other forms of capital.

So we just – we want to make sure that we keep doing the diligence around our expenses and we have further identified areas where we can really reduce expenses to make sure our cash keeps us through 2023 and into 2024, so that we’re not forced to do anything.

But look, it would be great to be able to do some sort of strategic partnership with a company if we thought it was the right thing and if we thought it was really going to accelerate our growth. And so, we’ll continue to look at that as well as a lot of other options as well. But nothing has been decided.

We haven’t – we just feel like given that the data is coming up this summer, that’s probably a good time to think about doing something. So thanks for the question..

Great, thanks for the color..

And thank you. And one moment for our next question. And our next question comes from Mitchell Kapoor from HCW. Your line is now open..

Hi, everyone. This is Mitchell on for Ram. Thanks for taking our questions.

The first one is I just wanted to ask about the main driver of JELMYTO uptake now and how that’s differed since the original launch? And how does the company intend to optimize the value ex-U.S.?.

Jeff, you want to take that and then I’ll take the ex-U.S. question..

Sure. So, hi Mitchell. The main driver continues to be patient identification getting into the offices and really sitting down and looking at various codes that help identify patients that could benefit from JELMYTO. But we – the data to continue to get better, we continue to do that.

And then, physicians, as you saw from the number that increase from repeat users, they also, once they get experience, they also look for other patients in the practice. We, obviously, have this data will be out there in the hands of the field. So prior to Q4 that we just reported this data wasn’t available.

So we’re certainly excited about the pieces of data, the long-term follow-up, Woldu which is the retrospective as well as the Rose paper which talks about additional integrated installations to continue to help us with get in new data is always a positive. It allows access.

Physicians are going to be very, and have been very interested in hearing about the new data since the real world is evidence is really how they’re using JELMYTO, which as you can see is oftentimes endoscopic resection, getting what they can see, understanding that there’s microscopic disease that they couldn’t see, and coming back with six doses of JELMYTO..

And on the ex-U.S. question, I think we – as we’ve talked about before, the challenge with ex-U.S. isn’t getting an approval on the data we have today. It’s really getting reimbursement. So for a market like Europe, for us to get reimbursement at a decent rate, that’s viable for us or a partner to go in there. We really need to do another study.

And so because we prioritize the work that we’re doing here in the U.S. for obvious reasons. So we see that down the road, but we absolutely see an opportunity to do more clinical work that would get us, global – give patients frankly global access. And right now we do have a Named Patient Program.

We actually have had a lot of success with a few patients, that have had good results after using it through the Named Patient Program because one piece of actually getting governments to pay is when physicians start asking for it.

So with a Named Patient Program and them getting some experience with that and their ability to be able to get access to it. So, right now we’re really focused on the U.S. and making sure we’re bringing 102, but we know what it would take to do something. And it would require another study outside the U.S..

Okay.

And then, yes, and on 102, just wanted to ask, if the commercial strategy will require any additional infrastructure in the U.S.?.

Yes, Jeff, do you want to just talk about sort of thoughts around that..

Sure. There’s a 95% overlap in key targets. It will not require a significant resource expansion. We’ll always take a look at larger geographies to cut down on windshield time. But because the overlap is so significant, I don’t see a reason for a larger major expansion with the hopeful approval of 102..

Okay. Great. Thank you all..

And thank you. And one moment for our next question. And our next question comes from Paul Choi from Goldman Sachs. Your line is now open..

Hi, this is Roderick for Paul Choi. Thanks for taking our questions.

So the first question is, what could drive further adoption of JELMYTO in 2023 and maybe potentially reach the higher end of your guidance? And maybe another question is in 2023 to anticipate to report additional real world data, including maybe the physician’s feedback based on the stability change in the label in this year? Thanks..

Jeff?.

Sure. I think the three pieces of data, actually four are going to drive greater adoption in 2023. I’ll start with the operational data that we have that the FDA approved an eight to 96-hour stability period that’s already resulted in 50% of doses being delivered day prior.

So we’ve been able to reengage physicians that may have been a little reluctant to adopt JELMYTO because of the eight-hour restriction. The second is certainly the question on long-term follow-up.

How long do patients stay disease free? And we’ve been able to from the OLYMPUS data follows a number of those patients where we see the median at 29 months. That’s although the number is follow-up is a little bit smaller, that’s pretty – that’s very significant.

When physicians question or wonder, well, OLYMPUS gave us 12 months upon approval, but now we see long-term follow-up with the median of 29 months. I think more importantly, the two pieces, the real world evidence talks about how physicians really practice and that’s going to be key.

And to go in and be a partner with multimodal what we use the term multimodal, be a partner with endoscopic resection.

And so for those physicians that may have only been resecting and holding off on using JELMYTO, you’ll be able to go in and talk about the difference in CR, when I say the – you the representatives will be able to get in and talk about the difference in CR, the increase in CR. And then finally the Dr.

Rose paper with 32 patients showing only a 9% stenosis rate with integrated administration versus the 44% that we saw in OLYMPUS. So all of those key pieces of data give me confidence to that we’re going to see growth in 2023 from that..

I think – it’s Liz. I’ll just add one more comment around the 96 hours. The other thing that 96 hours does for us is it actually frees up our rep. Because in a lot of cases, when you only had eight hours, the rep had to make sure that the dose got to the doctor’s office on time or the hospital or wherever it was going.

And now that we have more time, they don’t have to worry about that. And so that’s actually very helpful. So they can spend their time actually out generating more patients and generating demand versus really babysitting the dose to make sure it gets to the doctor’s office. But thanks for the questions..

Thank you..

And thank you. And one moment for our next question. And our next question comes from Boris Peaker from TD Cowen. Your line is now open..

Great, thanks. This is Nick on for Boris. I just have a quick question, or quick two questions on the ATLAS trial. Will you be releasing the TURBT patient data from ATLAS? I know that you’re planning to release about 280 patients worth of data.

Does that include TURBT? And then also from the UGN-102 arm of the ATLAS trial, will this will allow for a potential read through to the ENVISION trial?.

Mark, do you want to give your perspective and then I’ll add any commentary..

Sure. Thanks for the question. The answer is that we will be releasing the data from the TUR arm as well. I would caution everybody to remember that because the study is underpowered, we will not be able to compare the arms.

However, it will give us a sense in this cohort of the performance of surgery and probably as or more importantly safety issues around surgery in this population, which is an area of some interest in study in our community right now.

And then secondarily in the 102 arm, I think we have said on multiple occasions we will be providing complete response and durability data as well as safety data for that group of patients.

And with caveat, again about not being able to compare arms, we do believe that given the substantial comparability of this population to the OPTIMA population reported in our Phase 2 experience, we believe that it will be supportive and directionally in line with what we’ve previously reported and what we would expect to see in the ENVISION cohort as well..

Yes. So I’ll just add two caveats, right. The – our OPTIMA II study was only 65 patients. Typically, if you look at clinical studies and look, I haven’t seen the data, so I have no idea. You typically see somewhat of a decline, right, in efficacy, because you have a much bigger patient population. So we’ll see.

But we believe to Mark’s point, that it will be that will definitely be aligned in that case. The other thing is that just to also want to caution everybody on the data that we will share, because we will share top line data.

But we will not share all of the data, mainly just because we want to get a publication, a peer review – in a peer review journal, and we want it presented at a meeting. And that if we give all of the data, that won’t happen. So we will give top line data, we won’t go into all of the details.

But we will get that out in a paper as a presentation as quickly as possible. So thank you for the questions..

Yes, thank you very much.

Just on UGN-102, the at home administration, do you plan to run an additional trial for this? Or like, is this more so going to be just for physicians to see and potentially then use if they need to?.

Yes, we’re not planning to run another study. I think from our perspective, there were a couple things, right. We were in the middle of COVID, when actually it was our Chairman, Arie suggested it.

You are hearing a lot more around, frankly, home is a hospital I think is coin a phrase that we've heard, bringing it home and we think that there'll be an opportunity in the future, but reality of it is, is that most patients, and then we even saw that even in that study, most patients want to go into the doctor's office, and so, but we do think, maybe in nursing homes and there's opportunity.

So I think we'll see what the demand is for once 102 is approved and absolutely we could support an investigator-initiated study in bigger study. But the likelihood of us doing a large study to go after an approval, I would say probably not very likely.

But I think the data will allow, I mean, there's not going to be anything in our label that wouldn't allow for home delivery through a nurse, a home health nurse, just like they get other things through home health today. So I'm not sure that we need a study to be able to do that..

Great. Thank you very much..

Thank you..

And thank you. And one moment for our next question. And our next question comes from Matt Kaplan from Ladenburg Thalmann. Your line is now open..

Hi, good morning. And thanks for taking the questions. Just to want to dig in a little bit more to JELMYTO and your revenue guidance and specifically potentially returning to more accelerated growth of JELMYTO.

Can you talk a little bit about the current use and adoption of the nephrostomy tube in terms of administration of JELMYTO, and what are your thoughts kind of going forward in terms of that helping to drive growth further?.

Jeff?.

Sure. Hi Matt. Thank you for the question. It continues to go up. You listen every quarter, it goes up a certain percentage of 5% or 10%. I think with the Dr. Rose paper, you're going to see a bump in physicians that maybe have been a little reluctant if they just really wanted more data.

Now 32 patients, you have a similar if not better CR and then you have most importantly is a reduction in stenosis. I don't ever – I can say for a fact, it will never be 100% of the installations. Sometimes patients don't really want the catheter in their back for six weeks. So there will always going to be a subset of retrograde installations.

But I do see it continuing in the next few quarters because of the Rose data, 5% or 10% every quarter and the convenience to patients, as physicians experience being able to give this in the clinic, what we see is usually their first attempt at antegrade leads to future attempts at antegrade.

So as they identify patients they no longer give it in a retrograde fashion. They've moved their administration to strictly antegrade..

Great.

And then a follow up with respect to the impact on the stability period, when do you think you'll – obviously it's early in a label change, but when do you think you'll see kind of a full impact on improving adoption in driving growth?.

I think Q2, we've already seen it go from 20% to 50% in a short period of time, a day before installations. I think you're going to – can see that continue to increase. Look, some physicians still don't need it the day, the day before, just depending on when they want to do the procedure.

But I think what it does is if 50% or the day before, it's freeing up, as Liz alluded to earlier that time of the representative. And so you'll start to see more demand driven activities from the representative versus really ensuring that operationally the dose arrives.

So as our independent pharmacies and our partner pharmacy, the mixer that we currently use, adopt and get used to mixing later in the day and delivering it later that'll continue to become more efficient. And we'll follow the guidance of the practice. If they were required it the day before, we'll continue to evolve there.

So Q2, Q3 would be the impact and then from there on forward, in the end it frees up more time for the representative. And as we deliver the dose the day before..

And Matt – sorry Matt, I was just going to comment to your question around the growth, I mean, I think what we have said, and I think what we continue to see is slow steady growth. So unlike, will there be a time where you'll see a hockey stick inflection point? We don't think so. We think that it will continue to grow.

We are seeing that, we're seeing more stability, more consistency, and you'll continue to see that. And I think that is reflected in our guidance for the year. But, we're happy about that.

It's good to see that consistent growth but I don't – we don't think that even given the great data that we have, we think we'll continue to get more and more physicians. And we've been adding physicians every quarter. We add physicians, new physicians, and it does get back to what Jeff said earlier around finding the patients.

Again, there's 6,000 to 7,000 of these patients being treated by 10,000 physicians. So it's always a matter of being in the doctor's office at the time that they identify that patient. But thanks for your question. I hope that helps..

No, that's helpful.

And then just a question on 102, given the expectation for top line data in the middle of this year, 2023, can you elaborate more on the regulatory timeline for the product and the rate limiting step, whether it's CMC or long-term follow up? What's going to – what's the rate limit step as to apply it for you?.

It really is durability. Waiting for durability, the agency was very clear and we've talked about that as well, that durability is very important. So even though complete responses are primary endpoint, a key secondary endpoint is durability. And the FDA wants to see some strong durability data.

So we have to wait until, remember, we look at CR after three months from the time they started therapy, and then we need all of those patients to have a minimum of 12 months. The good news is, obviously some of them will have more than that.

And that was the strategy we used with JELMYTO is we didn't wait for everybody to have long-term follow up, but we were able to go in there with the majority of them. For 102, we'll wait for everybody to have 12 months post their CR and that will give us some strong data in which to go forward to the FDA. So that's really what's driving the timing.

CMC knock on wood in this case, because it is so similar to JELMYTO, we don't really foresee any issues there. We think that will go very smoothly. And so it really is just a matter of the clinical data and getting that the database cleaned, once we get the durability and having that data to go forward.

So we haven't given a time exactly of when we're going to file. And I’ll let you know, it is also an event driven study, right. So in addition, we have to know, we have a certain number of events as well. And so that's what will drive it.

So we're comfortable saying 2024 and we're comfortable saying that, if given priority review, we could potentially get at the end of 2024 or beginning of 2025..

So durability data, first half of 2024, is that the expectation?.

Well, yes, exactly. Absolutely..

Okay. Thank you.

And last question in terms of 301, what will you be looking for on the data 301 when that reports out later this year?.

Yes.

Mark, you want to talk about 301?.

Yes, sure. Thanks, Matt. So what we're currently doing is dose escalating 301, and that obviously is predominantly a safety experience for the appropriate dose. So the initial finding is going to be the appropriate dose. Subsequently our plan is, I think and others do is to combine this with other immunomodulators and chemotherapeutics.

So ultimately though, those data will not be forthcoming this year, hopefully in the near-term we'll be able to share combination data that would provide evidence of efficacy in this high grade population, which is obviously different than the JELMYTO and UGN-102 populations we've been focusing on.

But for right now what we're focusing on is finding the appropriate dose and demonstrating safety..

Thanks a lot guys..

And thank you. And one moment for our next question. And our next question comes from ‪AJ Velasquez Mao‬ from Jefferies. Your line is now open..

Hi y'all. This is AJ for Chris Howerton.

Just one additional question here, for the ENVISION trial, what gives you confidence that a single arm design is sufficient for approval? And would you consider or could you get like SPA agreement with the FDA?.

So Mark, do you want to talk about the feedback we got from the FDA and I can also add any color?.

Thank you, the confidence has to do with our interactions with the FDA in presenting our Phase 2 data and long conversations with them about the role we believe UGN-102 can play in neurologic practice.

So on the strength of the Phase 2 data, as well as our interactions with the agency, we believe and they have provided reassurance in writing that the design of the ENVISION trial would support approval of UGN-102 and that the decision will be based upon the totality of the data we present to them..

Yes, I think the only other thing, I'll add is and two things about SPA, I mean, the agency doesn't do SPAs very often any longer. And so we would've had to have done that before. So no, we don't have a special protocol assessment with the FDA.

But we do have our minutes from our meeting that says that a single arm study can be the basis for an approval. And they've made it very clear, we've shared this before that we'll go to an ODAC. And frankly, we're very happy to go to ODAC. We believe we'll win in an ODAC, we know that physicians want access to this medicine.

And so we're very comfortable and confident with that. And as Mark mentioned, what they say is it's got to be clinically meaningful and it's based on the totality of the data, which is not different than what they would expect to say. We would expect them to say.

But the good news is, is that what we have to everybody has to keep in mind here is there is not another therapy to compare UGN-102 to, the only other treatment is surgery.

And there has never been in any – across any therapeutic area, a study that had to be done to get a therapeutic approved that where they had to demonstrate how it did versus surgery. It was always looked at as an option to surgery. And so, that was part of the argument, we had with the FDA and the discussions around it and they agreed.

And add that to the complexity of trying to make a comparison to a surgery. And that's why ultimately the FDA agreed, they just weren't comfortable, frankly, we asked for approval on our Phase 2 study. They just weren't comfortable with 65 patients. So they're like, we need a much larger patient population. And we agreed with them on the 220 patients.

So I hope that helps..

Very helpful. Thank you. .

And thank you. And I am showing no further questions. I would now like to turn the call back over to Liz Barrett for closing remarks..

Thank you, operator. And again, as always, we really appreciate your interest in our company.

We're very excited about what's happening with JELMYTO, we're very excited about the fact that this year we'll actually be able to share data on a significant number of patients for UGN-102, as everybody knows, that's been a highly anticipated medicine for us. And we appreciate everything and look forward to sort of sharing more as the year goes on.

So let us know if you have any additional questions, always happy to jump on the phone. So operator, you can now disconnect. Thanks to everyone..

This concludes today's conference call. Thank you for participating. You may now disconnect..