UroGen Pharma - Q3 2023

Transcript

Operator (participant)

Good morning, ladies and gentlemen, and thank you for standing by, and welcome to the UroGen Pharma Q3 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 Perrone, Head of Investor Relations. You may begin.

Vincent Perrone (Senior Director, Investor Relations)

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's third quarter 2023 financial results and business update conference call. Earlier this morning, we issued our third quarter press release and filed our 10-Q, where you can find details for our financial and operating results. Both documents 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, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercial strategy and expectation, as well as potential future commercialization activities for UGN-102, if approved.

Anticipated data, regulatory filings and decisions, including UGN-102, potentially receiving priority review. UGN-102 being the growth driver for UroGen if approved, future research and development efforts, our corporate goals, 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'll now turn the call over to Liz. Liz?

Liz Barrett (President and CEO)

Thank you, Vincent, and welcome to everyone joining us today. Before we remark on the quarter, I must mention the October seventh attack on Israel and its impact on our Israeli colleagues, partners, and investors. The safety of our employees is and will continue to be top of mind. With regard to any potential impact to our business operations, I want to assure our shareholders that while we have a portion of our workforce based in Israel, we have robust contingency plans and international partnerships in place to ensure the continued smooth operation of our business. As a result, we do not anticipate any significant impact on our business or our operations. Finally, we hope and pray for peace to return to the region as soon as possible. I'll now turn to the quarter. Q3 2023 was one of the most important quarters in UroGen's history.

During the third quarter, we shared extraordinary top-line results from our phase 3 clinical trials, evaluating the use of UGN-102 to treat patients with low-grade, intermediate-risk, non-muscle invasive bladder cancer. Both the ATLAS and ENVISION trials met their primary endpoints, demonstrating meaningful and compelling results overall, and compared to the current standard of care, TURBT. This is particularly notable because UGN-102 is being developed as the first non-surgical therapy for this type of bladder cancer. Mark will talk more about this, but it's important to delineate the various types of bladder cancer and understand that our products are being studied in patient segments that are not being studied by other medicines. Following this announcement, we held a pre-NDA meeting with the FDA to align on the regulatory path forward for UGN-102.

As expected, the FDA confirmed that the current clinical development plan for UGN-102, which includes evaluation of duration of response at 12 months following a CR at 3 months in the pivotal ENVISION trial, will support submission of an NDA. The FDA also agreed that our NDA can utilize a rolling review, allowing for early submission of CMC sections of the NDA, which is planned for January 2024. Looking ahead, we anticipate sharing data from the duration of response endpoint in the second quarter of 2024. Pending favorable results, we expect to submit the NDA to the FDA a few months later. If granted priority review, we anticipate approval and launch in early 2025.

If approved, we believe that UGN-102 would represent a groundbreaking non-surgical option for approximately 82,000 annual patients suffering from low-grade, intermediate-risk, non-muscle invasive bladder cancer, who currently face frequent recurrences, necessitating the need for multiple surgeries. This potential milestone stands to become a major growth driver for UroGen, with a substantial market in the U.S. exceeding $3 billion. Q3 2023 was also the second strongest revenue quarter for JELMYTO in low-grade urothelial carcinoma. We're pleased with the pace of growth for JELMYTO, especially when considering this is a rare disease treated in both community and academic centers. We will continue to drive growth and meaningful adoption through increasing sites of care and leveraging the growing body of real-world data, highlighting JELMYTO's meaningful value and as part of a multimodal kidney-sparing approach to disease management.

For the third quarter, we reported $20.9 million in JELMYTO net revenues, an increase of 30% year-over-year. We believe there remains significant growth opportunity for JELMYTO as the first medicine ever approved for low-grade UTUC, bringing a differentiated chemoablative approach to patients. The closing of our $120 million private placement during the third quarter was an important milestone that significantly strengthened our balance sheet. Given our fortified financial position, we are committed to deploying capital to maximize shareholder value and plan to utilize proceeds from the raise to develop and execute a comprehensive pre-commercialization and launch strategy for UGN-102, while continuing to grow JELMYTO. Importantly, and based on our latest financial forecast, we believe our current cash position will support our commercial organization through the prospective launch of UGN-102.

Q3 2023 was a transformative quarter for UroGen, following strong top-line data from ATLAS and ENVISION and our pre-NDA meeting with the FDA. We have a clear path forward towards an approval for UGN-102 in low-grade intermediate-risk non-muscle invasive bladder cancer. Meanwhile, JELMYTO continues to grow its footprint in low-grade UTUC. I'm very proud of the dedication and commitment across our organization as we remain focused on pioneering a new era in urologic and specialty cancer care. UroGen is at its strongest and most encouraging point in the company's history. I'll now pass the call to Mark, who will provide a clinical update. Mark?

Mark Schoenberg (Chief Medical Officer)

Thank you, Liz, and hello, everyone. I'd like to take a moment to briefly summarize top-line results from the ATLAS and ENVISION trials before commenting on our recent pre-NDA meeting with the FDA. As a reminder, ATLAS was an open-label, randomized, controlled Phase 3 study designed to evaluate UGN-102 with or without TURBT versus TURBT alone. The trial enrolled 282 new and recurrent low-grade intermediate-risk NMIBC patients. ATLAS met its primary endpoint of disease-free survival, with UGN-102 demonstrating superiority to TURBT, with a 55% reduction of risk for recurrence, progression, or death in patients who received UGN-102. UGN-102 also showed a 65% complete response rate at three months for patients who only received UGN-102, compared to a 64% complete response rate at three months for patients who only received TURBT.

When we evaluate the subgroup of patients in ATLAS with recurrent disease and a history of at least one prior TURBT, the observed duration of response in the UGN-102 treatment group was a resounding 66.3%, 12 months after achieving a complete response or 15 months post-randomization. This is in comparison to 40% duration of response observed in the TURBT arm at the same time point. These results offer compelling insight into the effect of UGN-102 in recurrent patients, which is the population studied in our pivotal trial, ENVISION. During our recent pre-NDA meeting, FDA reaffirmed that ENVISION will serve as the pivotal trial for UGN-102 NDA. ENVISION, which is a single-arm study of UGN-102, enrolled 242 recurrent low-grade intermediate-risk NMIBC patients with a history of at least one prior TURBT.

The study met its primary endpoint, demonstrating that patients treated with UGN-102 experienced an impressive 79% complete response rate at three months following initiation of treatment. When looking at the totality of clinical data thus far, UGN-102 has demonstrated consistency in the three-month complete response endpoints across all three trials, a consistency and durability of response endpoints in ATLAS and OPTIMA, demonstrating a compelling therapeutic and safety profile throughout. For ENVISION, we maintain our view that a rate of duration and response of 50% or greater is a clinically meaningful outcome in this patient population. Given the consistency and the durability endpoints from ATLAS and OPTIMA, we anticipate potentially similar outcomes for ENVISION, which we believe would position UGN-102 for approval in low-grade intermediate-risk NMIBC.

Before turning the call over to Jeff for a commercial update, I'd like to briefly comment on the recently reported clinical data in bladder cancer from several of our peers. As a company, UroGen's mission is to build novel solutions to treat urothelial and specialty cancers because patients deserve better. We recognize the need for innovation and the development of new therapies in our space. Thus, we are encouraged that there are programs in development that may offer patients potentially better options than the current standard of care. However, as we near the final stages of clinical development for UGN-102, and with the prospect of commercialization on the horizon, we are discovering how the significant distinctions between low-grade and high-grade NMIBC, and even metastatic bladder cancer, may not be widely recognized.

Low-grade NMIBC, high-grade NMIBC, and metastatic bladder cancer are distinct types of bladder cancer with significant differences. Low-grade NMIBC is characterized by less aggressive tumors limited to the lining of the bladder and typically carries a better prognosis. High-grade disease, on the other hand, consists of more aggressive cancer cells within the bladder lining, which may have a higher risk of recurrence and progression. In contrast, metastatic bladder cancer represents the most advanced stage, where cancer has spread to distant organs, carrying a poor prognosis and necessitating systemic treatments. The key distinctions lie in tumor aggressiveness, location, treatment approaches, prognosis, and the stage of disease. It's important to understand that UGN-102 is focused on low-grade intermediate-risk NMIBC, where the competitive landscape is much less densely populated than in high-grade disease or metastatic disease.

Therefore, these recent data releases do not impact our current development, nor commercial plans, nor are expected to encroach on what we believe is a significant market opportunity for this program. We are hopeful that UGN-102 may potentially serve as the first non-surgical therapy for this indication, which represents a sizable, sizable portion of bladder cancer cases each year, and is also characterized by a high rate of recurrence. If approved, UGN-102 has the potential to shift the standard of care away from repetitive surgical care, and may improve the quality of life for tens of thousands of individuals battling this highly recurrent disease. With that, I'd like to turn the call over to Jeff for a commercial update. Jeff?

Jeffrey Bova (Chief Commercial Officer)

Thanks, Mark. Q3 was another strong quarter for JELMYTO. We had the second strongest quarter in our history, with continued momentum in our underlying business. We saw a small decrease from the prior quarter due to typical summer seasonality, and continue to see strong double-digit year-over-year growth in JELMYTO sales in what is now our third full year of commercialization. JELMYTO net sales for the third quarter were $20.9 million, which represents 30% growth from the same period last year. This growth in our top line reinforces our long-term belief in the low-grade UTUC opportunity. During the third quarter, further strengthening of the JELMYTO ramp and expansion of the JELMYTO user base was the result of several key factors, including continued commercial execution. JELMYTO offers clinical utility alone or following endoscopic management as part of a kidney-sparing treatment regimen.

The meaningful differentiated treatment profile of JELMYTO and its unique feature of being the only FDA-approved non-surgical treatment indicated for low-grade UTUC continues to resonate with both patients and physicians. In addition, the growing body of data from real-world evidence studies continues to strengthen and reinforce JELMYTO's value proposition, supporting its multimodal use across various practice patterns and diverse presentations. Our experience with JELMYTO has given us a foundation with urologists by establishing the use of mitomycin and RTGel. Consistent growth and adoption for this product reinforces our optimism for the significant opportunity in low-grade, intermediate-risk, non-muscle invasive bladder cancer with UGN-102. However, UGN-102 offers several distinct advantages over JELMYTO, including simpler administration and a much lighter operational lift.

Delivery of UGN-102, if approved, is expected to be easier for urologists, given that it does not require the use of specialized equipment, scheduling time in the OR, will be delivered pre-mixed with an anticipated one-week shelf life, and can be given by a doctor or support staff in clinic as an outpatient procedure. Importantly, we believe that the reimbursement economics for UGN-102 relative to TURBT will not be a barrier to adoption. Following the positive ATLAS and ENVISION data, we've begun executing our pre-commercialization plan in preparation for a prospective UGN-102 launch. With approximately 95% overlap in prescriber base and well-established practice patterns, we expect a seamless integration of UGN-102 into our commercial organization and an expedient launch upon approval.

If approved, we anticipate that UGN-102 will be the first-ever non-surgical treatment option for a disease afflicting approximately 82,000 patients in the U.S. each year, with a total market of more than $3 billion in the U.S. With that, I'll turn the call over to Don to discuss our financials. Don?

Don Kim (CFO)

Thank you, Jeff, and thank you to everyone for joining today's call. I'm pleased to review our financial results for the third quarter ended September 30, 2023. We are pleased to report another strong quarter of year-over-year revenue growth. For the third quarter of 2023, we reported JELMYTO net product revenues of $20.9 million, an increase of approximately 30% compared to $16.1 million in the same period last year. For the third quarter of 2023, research and development expenses were $10.2 million, as compared to $13.1 million for the same period in 2022.

The overall decrease is primarily due to lower expenses related to the conclusion of the ATLAS trial and lower cost of ENVISION trial for UGN-102, offset by higher R&D expenses related to phase 1 study for UGN-301 and ingredient scale-up and production for UGN-102. Selling, general, and administrative expenses for the third quarter 2023 were $21.8 million, compared to $19.1 million for the same period in 2022. The increase in SG&A is primarily due to higher marketing, commercial operations, professional services, and training, offset by lower commercial back-office services and support expenses. UGN reported a non-cash financing expense related to the prepaid forward obligation to RTW Investments of $5.5 million for the third quarter of 2023, compared to $4.8 million for the same period in 2022.

Interest expense related to the $100 million term loan facility with the funds managed by Pharmakon Advisors was $3.8 million for the third quarter of 2023, compared to $2.7 million for the same period last year. UroGen reported a net loss of $21.9 million or a basic and diluted net loss per ordinary share of $0.68 for the third quarter of 2023, as compared to $25.8 million or a basic and diluted net loss per ordinary shares of $1.13 for the same period in 2022. Turning to forward guidance, we reiterate anticipated full year 2023 net product revenues from JELMYTO to be in the range of $76 million-$86 million.

We reiterate the full year 2023 operating expenses to be in the range of $135 million-$145 million. The company reiterate anticipated full year 2023 non-cash financing expense related to the prepaid forward obligation to RTW Investments in the range of $21 million-$26 million. Of this amount, approximately $9.9 million-$11.2 million is expected to be in cash. We ended the third quarter with $153.9 million in cash and cash equivalents and marketable securities, which includes proceeds from the $120 million private placement, which closed during the third quarter. With that, I'd like to turn the call over to the operator for questions. Operator?

Operator (participant)

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question comes from Leland Gershell from Oppenheimer. Your line is now open.

Leland Gershell (Managing Director and Senior Biotechnology Analyst)

Hi, good morning. Thank you for taking the question. Just a few from me. Want to ask, Mark, in the FDA meeting, did you have any discussion around what range of durability from ENVISION the agency would like to see when you have that data?

Mark Schoenberg (Chief Medical Officer)

Leland, thanks for the question. As I think we've discussed previously, our interactions with the FDA have indicated that they are interested in, and we are going to provide a totality of the data regarding our datasets. And so no specific numerical bar has been discussed as a bar for approval, but the agency has indicated that it will be the entirety of and a clinical meaning of the outcome of these trials that will inform their decision regarding approval.

Leland Gershell (Managing Director and Senior Biotechnology Analyst)

Okay. And with respect to the ATLAS data, do we have a view on whether those will be part of one oh two's ultimate label at this point? How might those ATLAS data be, you know, the distribution of those things?

Mark Schoenberg (Chief Medical Officer)

Let me defer to Liz on that.

Liz Barrett (President and CEO)

Yeah. But, Leland, hi, nice to talk to you. Absolutely, the ATLAS data will be in the label. And, so yeah, we, we believe that the agency in the meeting, you know, talked about that data is supportive of our filing. So yes, we expect that to be in the filing, and we expect it to be able to use that data externally.

Leland Gershell (Managing Director and Senior Biotechnology Analyst)

Okay, great. Thanks. Just one last question for me. Liz, we had talked in the past about work you have been doing with respect to lengthening your intellectual property runway. Wondering if you might have any update on patent protections for 102.

Liz Barrett (President and CEO)

Yeah, no update specifically, except to tell you that you'll hear more in the very near future. And we are on track to you know to do that, and as what we've stated before, is minimally 2035, but we actually believe it will be 2041. So, we're working through final details, but no showstoppers, looks really great, and we hope to provide an update very shortly.

Leland Gershell (Managing Director and Senior Biotechnology Analyst)

Okay, great. Thanks so much for the update and taking the question.

Liz Barrett (President and CEO)

Absolutely. Thank you.

Operator (participant)

Thank you. One moment for our next question. Our next question comes from Raghuram Selvaraju from H.C. Wainwright & Co. Your line is now open.

Raghuram Selvaraju (Managing Director, Healthcare Equity Research)

Hi, thanks so much for taking my question, and congrats on all the progress recently. I just wanted to get an update on where you folks think you are operationally in terms of identifying any potential efficiencies or cost reductions. If you think that, in particular, on the G&A line, we might see some additional evidence of that being realized over the course of the coming quarters, or if you think at this juncture, you know, you've kind of reached optimum operating efficiency.

Liz Barrett (President and CEO)

Yeah, look, it's a great question. To be honest with you, you got to remember, we're about to prepare for a launch of a new medicine and one that is projected to be a blockbuster. So we are not looking at reducing expenses at this point. Obviously, we're very efficient. As a matter of fact, we're right now going through all of our operating plans. We remain very efficient, and I think the most important thing we're looking at is how much do we actually have to grow for UGN-102 and leveraging the organization that we have, and obviously shifting of some of the focus from JELMYTO to UGN-102 being the, you know, the, you know, broader opportunity for us from a patient perspective. So I don't really see us, you know, reducing expenses.

In some areas, absolutely. Like, you know, an example is in R&D, as we, you know, as we look at, you know, the ENVISION study and the ATLAS study coming to a close, you'll see some reductions there. But as we've talked about before, to extend the patent life, we'll be looking at adding a study, but it won't be at the same rate. So we'll definitely see some decreases, and we'll see some efficiencies across the board, but we're not looking at significant cost reduction in total. But we are being as efficient, and trust me, you know, challenging the team internally for particularly on infrastructure and ensuring that what, you know, we're only adding what we need, and we're, you know, shifting where we can.

And even looking at things like inventory and, you know, how much inventory do we need? The other thing to, just to sort of note in OpEx is that we have, you know, we also are ensuring our supply. So we're doing a lot around supply and secondary suppliers to ensure that there's no, disruption, and, and that's obviously, some incremental expense. You know, although, although not, not significant, but it, it is something that we wanna make sure that we don't have an issue with, with supply.

Raghuram Selvaraju (Managing Director, Healthcare Equity Research)

Okay, and then just a bifurcated question regarding, you know, the earlier stage pipeline and potential additions to the portfolio. If you look at 2024, can you give us a sense of what you expect to be the most important earlier-stage pipeline developments that you're anticipating over the course of next year, particularly if these pertain to zalifrelimab? And also any other potential pipeline programs that you anticipate would likely see notable advancement over the course of 2024, you know, with the exception, of course, of UGN-102, which I think is very much at the forefront of people's minds. And if you could also give us a sense of whether you are looking to add anything to broaden the portfolio within oncology via strategic licensing or M&A. Thank you.

Liz Barrett (President and CEO)

Great question. I'm gonna ask Mark to talk to answer the first one, and I'll come back and answer the second question. Mark?

Mark Schoenberg (Chief Medical Officer)

Yeah, thanks. So, we are advancing the phase 1 monotherapy program for zalifrelimab, the anti-CTLA-4 antibody for intravenous treatment of high-grade disease. As we've discussed previously, this is part of a master protocol that will permit us to study combinations with the antibody, and we are already in the process of creating those components of the trial. So we would expect next year to be able to talk about our monotherapy experience and update you on how our combination work is going, particularly with our TLR7 agonist, as well as potentially with other drugs of interest, such as gemcitabine.

Liz Barrett (President and CEO)

Yeah, and I think even from that standpoint, to answer sort of the second question, but part of that as well, is we also are looking at other products that are in the market that we would like to combine with Zalifrelimab and our technology. And so we are having active discussions with external companies. Nothing obviously to report right now, but it is a priority for us. To your second question, sure, we would love to bring in something, you know, in this space. It's a very active space, as you know, right now, with large pharma, but also in the biotech area. I think not likely in 2024 that we'll be doing that, but as we get into 2025, absolutely. The one thing that's really important about this business to note is this, this business is a highly leverageable business.

When we think about going in and being in uro-oncology, you can add multiple products to your portfolio and not have to add meaningfully to the infrastructure. So when you start to get down, you know, to one, two years post UGN-102, it's a very, you know, very significant improvement on our bottom line, which will give us the resources that we need to continue to build this company over the long haul. And the only other thing I'll mention is, you know, we also are interested in taking UGN-102 to high-grade disease. We're interested in taking UGN-102 to unwilling, unable, and the broader low-grade space. So there's a lot of things that we'll start to look at down the road.

And I think one of the other things I introduced, Michael Louie, is here with us. He's our new Vice President, Medical Affairs and Clinical Development, who's the lead on UGN-102. You know, is also looking at a registry for UGN-102, just like we're doing with JELMYTO, and we're seeing a lot of great data coming out of that registry that we'll start to publicize, and you'll see more publications in 2024 around that.

Raghuram Selvaraju (Managing Director, Healthcare Equity Research)

Thank you.

Operator (participant)

Thank you. One moment for our next question. Our next question comes from Boris Peaker from TD Cowen. Your line is now open.

Boris Peaker (Managing Director, Biotechnology Equity Research)

Great, thanks. Several questions for me. First, from the FDA discussion you've had, did they specifically say why they wouldn't accept ATLAS as a pivotal trial to support approval, just given the very strong hazard ratio and just efficacy data that study has reported?

Liz Barrett (President and CEO)

Yeah, Mark, do you wanna answer or you want me to?

Mark Schoenberg (Chief Medical Officer)

I'll start out, and Liz will undoubtedly comment. I think, you know, we had originally planned to enroll a larger number of patients in the ATLAS trial, substantially larger than we ultimately enrolled. The data are very strong, but I think the fact that we halted enrollment but continued the trial with a smaller number of patients than originally anticipated in the original statistical analysis plan, probably informed some of the FDA's position on the aggregate value of the ATLAS data as a standalone submission. But Liz may want to comment as well.

Liz Barrett (President and CEO)

No, I think that's right. Look, we tried, the data is very compelling. You know, they, you know, their initial stance on the data is it's exploratory. We made very clear that it is not exploratory data, it is significant data. They did, they did come around to that way of thinking. But given that the, and if you think about it from a prospective statistical analysis plan, you know, we didn't, we didn't reach the endpoints that we would have needed to reach, you know, to for that to be the pivotal study. So they, they just came back to... I will say, and, and Mark can say this as well, is, is it was a very positive study. Probably the meeting with them, it was the most positive they have ever been.

They were very impressed with the data. There was no pushback on the ENVISION, only, you know, "We want to see durability," which frankly, not only have they said that to us, they've said to everybody else in this space, "We want to see durability." You hear that, you know, every time you hear about somebody in bladder cancer. So it was really more a matter of prospective, you know, analysis plan and not being able to have, you know, that data in hand. But again, very, very positive interaction. But they've been very clear all along, you know, that they want to see durability, and durability is as important to them as CR. But that was it. I mean, we did try, Boris.

I mean, it was, obviously, we felt like compelling enough, data, but, but, you know, we understood and we knew that it was, you know, that it was a probability that they would say, "You've got, you know, if you-- we want to see the ENVISION, the, durability data," which is exactly what they said. So we feel like we're in a, very, very strong position with them and, and, and knowing exactly what they want to see, when they want to see it, and, and, you know, we're marching toward that.

Boris Peaker (Managing Director, Biotechnology Equity Research)

Great. And my last question here. You mentioned reimbursement economics, that the UGN-102 is more favorable than TURBT. Can you just talk about what those reimbursement economics are in various settings, maybe in academic centers versus, you know, private practices or however you want to divide them?

Liz Barrett (President and CEO)

Yeah, sure. Jeff will take you through that.

Jeffrey Bova (Chief Commercial Officer)

Hey, Boris. Yeah, so depending on the size of the tumor for TURBT, there isn't a significant amount that's reimbursed to the physician. I do think there's a per- maybe a perception that it's larger than what it is. But if you would, if you were to look at the reimbursement economics, and you couple in instillation of an anti-carcinogenic, which would be UGN-102 times six, as well as the buy and bill portion of the drug, which will be given in the clinic predominantly, so the physician would see that buy and bill versus a hospital, the economics look very good when compared to TURBT. I do, I don't-- we...

People need to understand that, surgeries or reimbursement for surgeries has gone down, and we see that as evidence of a TURBT. Obviously, it depends on the size of the tumor, but overall, the reimbursement we expect for UGN-102 to be better than TURBT.

Liz Barrett (President and CEO)

Yeah. And then, look, the only thing I'll comment about is, you know, we are, are not going out with a profitability message, right? That's not our message. We, we, we can't do that. We won't do that. But it will be very... You're right, Boris. It will be very important to them that they don't feel like they're losing money, that it's not a detriment to them, even though we know it's better medicine for the patient, which we'll, we'll focus on. But we do have field reimbursement managers. We will make sure that our reps are also armed and able to, to share the information that we can appropriately share, because it is an important piece, as you know. Unfortunately, you know, decisions get made that way.

But this is, you know, will be, you know, frankly, a net positive if they use it from a financial standpoint. But keep in mind, obviously, you know, our role and how we discuss that to the marketplace.

Boris Peaker (Managing Director, Biotechnology Equity Research)

Great. Thank you very much for taking my question.

Mark Schoenberg (Chief Medical Officer)

Thank you. One moment for our next question. Our next question comes from Paul Choi from Goldman Sachs. Your line is now open.

Paul Choi (Biotechnology Analyst)

Hi, thank you, and good morning, and congrats on the good quarter. I was just wondering for, from Mark, if you could maybe share any, additional feedback you've had, from the physician community since the, since the Investor Day, specifically, since the Society of Urologic Oncology is coming up here, any additional feedback you've gotten on ENVISION and ATLAS? Thank you.

Mark Schoenberg (Chief Medical Officer)

Paul, thanks for the question, and I may actually lean on Jeff as well to talk about this. But, you know, I think people are excited about the possibility of the approval of 102. I think everybody, specifically folks who work in urologic oncology, understand the need and specifically the unmet need in this population. So what I'm hearing from colleagues is anticipation that's positive. But Jeff, I don't know if you have additional-

Liz Barrett (President and CEO)

You want to talk about what some of the feedback you got at LUGPA?

Jeffrey Bova (Chief Commercial Officer)

Sure. So we just got back, hi, Paul, from LUGPA annual meeting, the larger groups. We had an advisory board there, where Dr. Prasad presented some of the data that we saw at AUA. And I think the initial reaction was overwhelmingly positive. It was designed to sort of get their feedback in and around the data. We workshopped a couple different patient types, but they're eager to have a different option. If you're on the conservative side of things, you know, they certainly have a number of patients that they do not want to put under general again and have a surgery, so there's that.

And then many of them reiterated that, you know, essentially, what looks like in at least ATLAS, it's the same for TURBT, and it's a much longer duration of response, which is obviously a key attribute if approved for UGN-102. So, that was 12, 13 advisors, very influential in the community. They gave us really strong feedback. We'll continue to obviously engage as we need that feedback, but that was just an initial reaction.

Paul Choi (Biotechnology Analyst)

Great. Thanks for that color. And as a follow-up, also for you, Jeff, just regarding your comments on the buy and bill process, can you maybe just give us some sense of what you think the runway will be before reimbursement and coding J-codes and so forth are established for 102, and just how you think the early mechanics might look like, you know, starting with a launch in 2025? Thank you.

Jeffrey Bova (Chief Commercial Officer)

Sure. As with any Part B drug, you will have a—we will have a miscellaneous code for a period of time. We did with JELMYTO. We expect that with 102 as well. As with any miscellaneous code, it's a manual process, so we have to really make sure that we're buttoned up on making sure that we support the office on how they fill everything out correctly with that miscellaneous code. I will say this, it will be clearer than JELMYTO, because with JELMYTO, you had to bill for both drug and waste. So you had a miscellaneous drug code, you had a miscellaneous waste code. Here, you won't have as many line items, so it'll be much more straightforward.

We will put things in place, you know, to sort of help with the anxiety in and around a miscellaneous code. We do expect, if approved in the timeline that we think we're gonna get. You know, the nice thing is CMS is reviewing miscellaneous codes more than once a year now. So we expect a J-code hopefully sooner because of that review process. But we will put those, you know, put things in place to get past that. But I always say, it's a miscellaneous code. It takes a little bit more time on the physician practice. You'll have your early adopters that will come out and use it and hopefully be reimbursed accurately. We can then, you know, share that.

They'll talk to their peers, and then hopefully by then, we have a permanent J-code.

Paul Choi (Biotechnology Analyst)

Great. Thank you.

Operator (participant)

Thank you. I'm showing no further questions. I would now like to turn the call back over to Liz Barrett for closing remarks.

Liz Barrett (President and CEO)

Thank you, and thanks to everybody for your continued interest in UroGen. I think, you know, it's been a tough market the last few weeks, but as everybody has seen, that we've made significant progress. We continue to make significant progress, both on JELMYTO and then, importantly, on UGN-102. So appreciate, we have a lot of key catalysts coming up in the next six months, so appreciate your interest, and we'll keep everybody posted. Thanks a lot. Appreciate it. Operator, you can now disconnect.

Operator (participant)

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