UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2024 Earnings Call Transcript

UroGen Pharma Ltd. (NASDAQ:URGN) Q4 2024 Earnings Call Transcript March 10, 2025

Operator: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the UroGen Pharma Fourth Quarter and Full Year 2024 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. Please go ahead.

Vincent Perrone: Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma’s fourth quarter and full year 2024 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 fourth quarter and year ended December 31, 2024. 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 CEO, Dr. Mark Schoenberg, CMO, David Lin, Chief Commercial Officer, and Chris Degnan, 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 commercialization strategy and expectations as well as potential future commercialization activities for UGN-102 if approved, anticipated data, regulatory filings and decisions, UGN-102 being the primary growth driver for UroGen if approved, future R&D, our corporate goals and 2025 financial guidance among other things.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. I’ll now turn the call over to Liz.

Liz Barrett: Thank you, Vincent, and thank you for joining us this morning. 2024 was a year of progress for UroGen as we continue to advance our mission of pioneering new therapies that meet the unique needs of patients with urothelial and specialty cancers. We achieved a major milestone by submitting a new drug application for UGN-102, our investigational product for intermediate risk, low grade, non-muscle invasive bladder cancer, ahead of schedule. With FDA review underway and a PDUFA target date of June 13. We are well positioned to bring this in and we have made meaningful progress advancing our early stage pipeline. Additionally, we strengthened our leadership team, ensuring we have the expertise and vision to drive UroGen’s next phase of success.

I will begin with an important clinical update on the pivotal ENVISION Phase 3 trial that serves as a foundation for the UGN-102 NDA submission. ENVISION demonstrated a compelling complete response rate and unprecedented durability. As a reminder, the CR rate at three months stood at an impressive 79.6%, and the 12-month duration of response was an unprecedented 82.3% Kaplan-Meier analysis. As the data continue to mature, we are highly encouraged by the disease free status of many patients in follow-up. Today, we are reporting updated 18-month duration of response data from ENVISION and note that these results remain consistent with our previous Kaplan-Meier estimate. With 102 patients now followed for at least 18 months following CR, or 21 months post therapy start, the updated duration of response is 80.6% by Kaplan-Meier analysis.

The median follow-up time for these patients has now extended to18.7 months after three months CR, up from 13.8 months at the previous data cut, and the median duration of response is still not reached. We have provided these data to the FDA in our 120-day update, and they will be part of the submission. The durability of response is critical for a disease with historically high recurrence rate. By extending disease free periods, UGN-102 has the potential to increase disease and treatment free intervals, which are associated with morbidity and quality of life challenges in this population. We engaged with the FDA in a productive mid cycle review meeting this past week. The agency confirmed they will be referring the NDA to ODAC. They previously indicated the meeting will take place in May, and we are awaiting official publication of the meeting date in the Federal Registry.

We aligned with the agency that the advisory committee presentation and materials were focused on the recurrent patient population studied in the ENVISION trial. Therefore, we believe that UGN-102, if approved, will be indicated in the recurrent patient population. It’s important to highlight that our data in this population is highly supportive, and this group represents the vast majority of the overall revenue opportunity. While these meetings are confidential and there’s a limit to what we can share today, I want to take this opportunity to reaffirm our confidence in the strength of the data package we have submitted and in the potential of UGN-102 to address a significant unmet need for patients. We remain fully focused on preparing for our ODAC and look forward to the opportunity to present our compelling data to the advisory committee and engage with the broader medical community.

If approved, UGN-102 will become the first medicine for this patient population, introducing a potentially paradigm shifting solution for this disease. An approval of UGN-102 will be transformative for UroGen as it represents a significant market opportunity, a population nearly 10 times larger than the market for JELMYTO. This translates to a total addressable market of more than $5 billion. Importantly, our ability to identify and target physicians and their patients for UGN-102 will be easier. Unlike low grade upper tracheal urothelial carcinoma, which is a dispersed rare disease, low grade intermediate risk non muscle invasive bladder cancer is widespread and managed by nearly all urologists. UGN-102 is designed for seamless integration into outpatient practice workflows.

The ease of use creates the opportunity for physicians to expand their practices and enhance patient care. JELMYTO generated net product revenues of $90.4 million for the full year 2024, compared to $82.7 million for the prior year. The increase of $7.7 million year-over-year was primarily driven by increased underlying demand for JELMYTO, partially offset by a decrease in CREATES Act sales and an increase in 340B chargebacks. If we focus on actual underlying product demand, sales grew by approximately 12% year-over-year. Our commercial team recognizes this is a high touch product, so we have been focused on increasing our reach and frequency with key accounts. This has resulted in consistent improvement across several key metrics, including overall volume, patient enrollment forms and new patient starts, new script writers and new sites of care.

In Q4 2024, we saw our highest ever number of demand units. David Lin will provide more details in his update. We have also made great progress in advancing our long-term growth strategy with the recent acquisition of ICVB-1042 from IconOVir. This next generation investigational oncolytic virus represents an exciting opportunity in cancer care. With its unique mechanism, ICVB-1042 is designed to selectively target and destroy tumor cells without compromising its lytic activity. It’s designed to enter a broad spectrum of tumor cells, allowing it to potentially treat a wide range of tumor types. This acquisition aligns with our vision and strategic focus to develop innovative therapies to address critical gaps in cancer care. For those interested, a replay of our investor webinar announcing the acquisition is available on our website.

UroGen ended 2024 with a strong balance sheet, holding $241.7 million in cash, cash equivalents and marketable securities. We remain well capitalized to execute our operating plan and advance the company to and through profitability with the anticipated launch of UGN-102 later this year. I will now turn the call over to Mark Schomberg, our Chief Medical Officer for a clinical update.

Mark Schoenberg: Thank you, Liz. Beginning with the NDA for UGN-102, our clinical and regulatory teams are fully engaged in preparing for the ODAC meeting where UGN-102 will be reviewed as a potential paradigm shift in the treatment of low grade intermediate risk non muscle invasive bladder cancer. We believe a key consideration for the FDA is that UGN-102 represents a fundamental change in how we approach this disease, moving away from repetitive surgical procedures that have been the standard for decades. We feel confident heading into this discussion. Urologists appreciate the need for alternative treatment options that could potentially provide a longer treatment and recurrence free survival, and UGN-102 has the potential to fill this gap, offering office based administration that aligns with the way urologists practice.

The body of clinical evidence supporting UGN-102 continues to grow. Liz highlighted the latest duration of response data from ENVISION, showing an impressive 80.6% duration of response at 18 months for those patients who had achieved a complete response of three months. We will continue to follow these patients, but the current data represent a potentially significant advance for patients as we have not reached a median duration of response. We continue to appropriately engage with the broader medical community to share our clinical findings from ENVISION. The ENVISION trial results were recently published in the February print edition of the Journal of Urology and were also presented at the Society of Urologic Oncology, or SUO, annual meeting, which took place in Dallas in December.

At SUO, we also had the opportunity to present long term follow-up data from the OLYMPUS trial, which demonstrated a median duration of response of approximately four years in patients who had achieved a complete response with JELMYTO. These data further reinforce JELMYTO’s role as a primary treatment for low grade upper tract urothelial cancer, providing patients with a meaningful alternative to surgery. In January, previously announced results from the real world post commercialization study of JELMYTO were published in urologic oncology. This long term study evaluated 56 patients from 15 high volume centers who achieved complete responses with JELMYTO, demonstrating a recurrence free survival rate of 68% at three years. Notably, recurrence free survival was consistent irrespective of tumor size, location, number of tumors and route of administration with no difference between primary chemoablation and as adjuvant therapy post endoscopic ablation.

These findings further support the use of JELMYTO in a broad patient population. Turning now to the pipeline, we have a comprehensive life cycle management plan for JELMYTO and UGN-102. Enrollment continues in the Phase 3 Utopia trial, which is evaluating UGN-103, our next generation product for low grade intermediate risk NMIDC. Utopia is a single arm multicenter study with a protocol similar to the ENVISION trial. Low grade intermediate risk disease patients with recurrent disease are receiving UGN-103 via intravesical installation once a week for six weeks. Efficacy will be assessed based on the complete response rate at the three month mark, and patients will be followed to evaluate durability of response. We expect to complete enrollment this year and anticipate reporting top line data in 2026.

We have a similar development plan for UGN-104, our next generation formulation of JELMYTO and expect to commence a single arm Phase 3 study in the first half of 2025. In February, we were pleased to announce the acquisition of ICVB-1042, a next generation oncolytic virus developed by IconOVir. This addition meaningfully enhances UroGen’s pipeline by introducing a highly innovative approach to selectively targeting and destroying cancer cells while simultaneously activating a robust antitumor immune response. 1042 was thoughtfully engineered to achieve efficient cell entry, strong selectivity for malignant cells and rapid replication within the tumor microenvironment, features that drive both direct tumor cell lysis and the induction of a durable tumor specific immune response.

Our development plan for 1042 is advancing with IND enabling studies expected to begin this year. We intend to evaluate several modes of administration, including delivery using our proprietary RTGel technology. While our initial focus will be on bladder cancer, we anticipate exploring 1042’s potential to address a broader range of malignancies beyond the genitourinary space. Finally, UroGen will have a significant presence at this year’s American Urology Association meeting to take place April 26 to 29 in Las Vegas, Nevada. This is an important conference for us and I’m pleased to say that we have six abstracts accepted this year. These include a podium presentation of the ENVISION trial results by Dr. Sandeep Prasad, the principal investigator of the UGN-102 trial.

Now over to David Lin for a commercial update.

David Lin: Thank you, Mark. Good morning, everyone. I’m pleased to provide an update on our commercial initiatives as we move closer to the PDUFA target action date for UGN-102. The upcoming launch would mark a pivotal moment in UroGen’s evolution from a rare disease focused company to a multiproduct specialty driven team. Our goal is to deliver a seamless and successful launch, ensuring that our efforts translate into patient access to this potentially groundbreaking therapeutic option. Our immediate priority is continuing to execute our comprehensive pre commercial strategy that we believe will lay a strong foundation for widespread access and adoption of UGN-102. We are confident in the strength of our clinical data and the potential it holds for patients with low grade intermediate risk non muscle invasive bladder cancer.

We’re focused on three key priorities in our preapproval preparation. First, we’re actively working to raise awareness about the unmet needs in low grade intermediate risk non muscle invasive bladder cancer through a variety of educational programs. Our medical affairs team is engaging in scientific exchange activities involving the clinical data supporting UGN-102. Next, we continue to gather insights across key stakeholders such as prescribers, payers, and patients in order to refine our launch plans. Of course, we’ll leverage learnings we have gained through our experience with JELMYTO. And finally, we are scaling our commercial infrastructure and capabilities to ensure we’re appropriately sized to fully address the opportunity for UGN-102 if approved.

We are significantly expanding our sales force from 52 reps today to approximately 83 at our anticipated launch. We are also building out our customer support capabilities to support a broader portfolio, particularly in our ability to provide comprehensive training and support for healthcare professionals and their staff to ensure seamless integration of UGN-102 into treatment protocols. Additionally, we are preparing our engagement initiatives to inform both clinical practices and patients about UGN-102’s coverage options and reimbursement. While UGN-102 will initially be assigned a miscellaneous J-code for billing, we expect to secure a permanent J-code by January 2026, which will be particularly important in the community setting. In the interim, we are fully committed to offering strong reimbursement support to help providers navigate the coding process, helping to ensure the integration of UGN-102 is as smooth as possible.

We are on the cusp of a truly exciting launch, and we are energized by the opportunity to bring this investigational treatment to patients and continue making strides in the fight against bladder cancer. Turning to JELMYTO, as Liz mentioned, the product delivered $87.4 million in underlying demand revenue in 2024, an increase of 12% versus the prior year. Fourth quarter underlying demand revenues increased 15% year-over-year, and we saw consistent improvement across multiple key metrics. Demand units in Q4 were our highest ever, up 15% compared to Q4 of last year. New prescribers and new patient starts increased 33% and 13%, respectively, in 2024 compared to 2023. The recent clinical data and publications that Mark referenced, including the long term follow-up from OLYMPUS and positive results from the real world study, further underscore the impressive durability of JELMYTO.

These results continue to reinforce its important role in treating low grade upper tract urothelial cancer. We are continuing our high touch strategy with a focused effort on key accounts, ensuring JELMYTO remains a key part of our commercial portfolio. As we expand our sales force in preparation for the UGN-102 launch, the new representatives will also be promoting JELMYTO. This strategic increase in our sales team is designed to drive growth for both products, enhancing our ability to support key accounts and maximize market impact. I will now turn the call over to Chris Degnan to discuss our financials.

Chris Degnan: Thank you, David. Before I turn to our financial results, I’m pleased to report UroGen entered 2025 from a position of financial strength. At the close of 2024, cash, cash equivalents and marketable securities totaled $241.7 million, providing a solid foundation to continue executing on our strategic initiatives. With the anticipated launch of UGN-102 later this year, we are well equipped to drive our company towards profitability and create long term value for our shareholders. Turning now to our financial results. JELMYTO net product revenues were $24.6 million in the fourth quarter of 2024 compared to $23.5 million for the same period in 2023. Underlying demand revenue increased by 15%, partially offset by a decrease in CREATES Act sales, which totaled $0.2 million in the fourth quarter of 2024 compared to $2.4 million for the same period in 2023.

JELMYTO net product revenues for the full year ended December 31, 2024 were $90.4 million compared with $82.7 million of revenue in 2023. Research and development expenses for the fourth quarter of 2024 were $14.9 million as compared to $11.3 million for the same period in 2023. R&D expenses for the full year 2024 were $57.1 million compared with $45.6 million for 2023. The year-over-year increase was primarily driven by manufacturing expenses for our product candidates, regulatory expenses related to UGN-102 and costs associated with the UGN-103 Utopia trial. SG&A expenses for the fourth quarter of 2024 were $34.9 million compared to $24.6 million in the same period in 2023. For the full year 2024, SG& A expenses were $121.2 million compared with $93.3 million in 2023.

The year-over-year increase was primarily driven by UGN-102 commercial preparation activities. We reported non-cash financing expense related to the prepaid forward obligation to RTW investments of $6.1 million in the fourth quarter of 2024 compared to $5.5 million in the same period in 2023. Non cash financing expense related to RTW investments was $23.4 million in the full year 2024 compared with $21.6 million in 2023. Interest expense related to the outstanding $125 million term loan facility with Pharmakon Advisors was $3.9 million and $12.5 million respectively for the fourth quarter and full year 2024 compared with $3.6 million and $14.7 million respectively for the fourth quarter and full year 2023. Net loss was $37.5 million or $0.80 per basic and diluted share in the fourth quarter of 2024 compared with a net loss of $26 million or $0.72 per basic and diluted share in the same period in 2023.

For the full year 2024, net loss was $126.9 million or $2.96 per basic and diluted share compared with a net loss of $102.2 million or $3.55 per basic and diluted share in 2023. Turning to forward guidance for 2025. The company expects full year 2025 JELMYTO revenues to be in the range of $94 million to $98 million. This implies a year-over-year growth rate of approximately 8% to 12% over the $87.4 million in demand driven JELMYTO revenues in 2024, which excludes the $3 million in CREATES Act sales reported in 2024. Full year 2025 operating expenses are expected to be in the range of $215 million to $225 million including non-cash share based compensation expense of $11 million to $14 million. The anticipated increase in full year operating expenses is primarily driven by the planned sales force expansion and additional commercial and medical activities to support the UGN-102 launch as well as the advancement of our UGN-103 and UGN-104 clinical programs.

We are now ready to open the call for questions. Operator?

Q&A Session

Operator: Our first question is going to come from the line of Tara Bancroft with TD Cowen. Your line is open. Please go ahead.

Unidentified Analyst: Great. Thanks. This is Nick on for Tara. You noted on the call that you anticipate approval in the recurrent setting. Do you anticipate that UGN-102 could still be used in the about 10% of patients or so that are ineligible for surgery, which would be the frontline setting? And would this then require to be used off label? Thanks.

Liz Barrett: Yeah. Hi, Nick. It’s Liz. Yeah. I think that would be considered off label. So, clearly, we wouldn’t be able to promote there, and I think it would be up to the physician to work with their insurance company because that’s really what it comes down to. It’s really more of a situation of making sure that they can get paid for it. So, you know, as we’ve talked about before, we actually thought they might go there. They did in the meeting, and it was really driven by the fact that they always viewed that as being the unmet need. And it doesn’t change our revenue projections and be really clear about that. So, we still believe that the medicine 102 will be over a billion dollars revenue, and that doesn’t change that.

And it never did. It was more of exactly what you’re talking about. Like, we wanted physicians to have the ability for those few patients that they really don’t want to put under because we all know that the newly diagnosed patients, they almost all of them get a TRBT for diagnostic purposes, but there are a handful of patients that physicians would just prefer not to put under. Mark can comment, I think, about what would happen. They usually do it anyway. Right? And it’s a little bit more risky, and physicians have told us they would like to be able to make that choice and not the FDA. But it was clear in the conversation that we had with them. And we had discussed it internally and knew that if they did go there, it’s better for us, frankly, to go into the ODAC aligned with them on that so that we don’t spend time in the ODAC, talk going back and forth on that, and that we also don’t risk a negative vote because panelists say, well, I don’t want the newly diagnosed.

So, this obviously makes it a smaller patient population, but not really smaller from a from a business opportunity. But to your point, it would be up to the physician to work with the payer and the patient for them to get reimbursed. And we obviously think about whether we should do some clinical work in this space or not, but it’s a very small financial opportunity. Again, just a matter of being able to help physicians make it easier for them to use.

Operator: Our next question will be coming from the line of Michael Schmidt with Guggenheim. Your line is open. Please go ahead.

Michael Schmidt: Hey, good morning. Thanks for taking our questions. On UGN-102, as you think about the potential FDA approval later this summer in June, how should investors think about the initial launch trajectory perhaps relative to JELMYTO or other potential benchmarks? Are there any analogs that we should look at? And then, how should we think about pricing again of one or two relative to JELMYTO? And would you expect any meaningful channel inventory builds early this year?

David Lin: In terms of launch trajectory, we intend to continue educating our physician provider universe and obviously maintaining a lot of support. So, the way we’re thinking about the overall shape of the curve is very akin to how we thought about JELMYTO. While the absolute numbers would be larger because of the patient population, The overall shape we are modeling very similar to that of JELMYO because there’s a lot of similarities in terms of the operational considerations. On your question with regard to pricing, I think we continue to think of pricing in the $18,000 to $19,000 per dose. However, we continue to do research with payers to refine our assumptions. But that’s how we’re thinking about it for right now.

Operator: Our next question is going to come from the line of Raghuram Selvaraju with H. C. Wainwright. Your line is open. Please go ahead.

Raghuram Selvaraju: Thanks so much for taking our questions. Firstly, with respect to UGN-102 and the projected reimbursement environment, I was just wondering if you could maybe provide us with additional granularity regarding the difference in reimbursement level and degree of market access that you expect to have during the period immediately after launch when you’ll have the generic J-code and once you actually have the specific J-code in January of 2026, just kind of spell out for us how the environment is going to change when you shift from one J code to another? And then secondly, with regard to the pipeline development activities, can you give us some update on how enrollment kinetics appear to be progressing in the UGN-103 program? And if you still expect to be in a position to report data from that trial either next year or in 2027? Thank you.

David Lin: From a reimbursement perspective, as we stated in the initial six months assuming the June 13 action date, we do anticipate a miscellaneous J-code being used. Essentially what this means from an assumption standpoint is that the overall reimbursement process we believe takes a little bit longer. So, somewhere around the 50 day to 60 days for a provider to be reimbursed. And that number does cut down by about half when we have a unique permanent miscellaneous J-code, which we assume will be in the January 2026 timeframe. So, our real focus is going to be making sure that we are with our accounts supporting them in the coding and reimbursement process to guide them through that initial period. And so, we will continue to provide the same level of support as we are now just to a broader audience.

Liz Barrett: We will have services to get physicians through that time period. So, like we did with JELMYTO, we’ll have longer dating so they don’t have to put the money out before they get reimbursed as well as the hub. And the other thing that I’ll comment on is we also expect, like we saw with JELMYTO, that the initial uptake from a site of care perspective will be more in the hospital and the institutions because the pharmacy takes the risk at that point in time and not the private practice. So, where J-code becomes more challenging is really the private practices who are concerned about putting out that kind of money and taking the risk of not being reimbursed. So, we expect those physicians would just take their patient to the hospital or the institution in which they’re affiliated, and they would they would conduct the therapy at that place.

So, again, as David mentioned earlier, I think you can’t look at JELMYTO in the initial couple of first 18 months. I would not look at JELMYTO post those 18 months because we do believe that the opportunity is far greater for UGN-102, and we should see an acceleration that’s greater than we see with JELMYTO. But the first couple of years of JELMYTO, if you see, in our first year, we sold around the same six months, around almost $15 million in revenue, and then it went up to almost $50 million in the sec in the full year following. So, I would use that as a good analog for the first 18 months. So, hopefully, that helps.

Raghuram Selvaraju: Well, what I would also mention, of course, is for those who remember, you launched JELMYTO in the middle of a pandemic, and that will clearly not be the case with 102.

Liz Barrett: Exactly. Absolutely. But, you know, like, if you just take into consideration, and I’m not suggesting the same amount of revenue, but to David’s point earlier, it’s a much bigger patient population. The price may be, you know, a little bit less, but you can see at 10 times the size, even if JELMYTO were the analog, it would it’d still be a very positive for the first few months of the launch. But you’re absolutely right. We launched into a pandemic. And, hopefully, knock on wood, everybody, we won’t be having a pandemic in 2025 and 2026. then I’ll turn it over to Mark to answer the question.

Mark Schoenberg: Yeah. Thanks, Liz. With respect to 103 and the trial is the Utopia trial, we’re anticipating complete enrollment this year, data in ’26 and approval in ’27. So, it’s sort of a lockstep progression, but things are going well and we’re very optimistic that we’re going be able to keep to that timeline.

Operator: Our next question is going to come from the line of Leland Gershel with Oppenheimer. Your line is open.

Leland Gershel: Good morning and thanks for the update and taking our questions. Just one from us. Just teeing off the other question about examining treatment naive patients with low grade. Just wondering given the ongoing trial with 103, if you would look to possibly amend that or if you would look to do further study in treatment naive for the benefit of 103 eventual label? Thank you.

Liz Barrett: Yes, it’s a great question, Leland. And to be honest with you, this just happened last week. So, we haven’t spent a lot of time thinking about it. I think at the end of the day, it would more likely be around generating data in real world use, maybe like a registry or through an IIR. But because, as I mentioned, the opportunity is fairly small, although the good news with UGN-103 is that we would be moving to our patent protection on that medicine will be until through 2041. So, we have a lot of time. I think we would take a look at it, but, no, we would not amend the current 103. And the reason we would not amend the 103 is because we need to keep that study as close to UGN-102 as possible because that’s what they’ll be using as a comparison.

Right? So, to get that drug approved and approved quickly, they’ll be using UGN-102. So, you want to keep that study as quickly as possible, but we’ll evaluate UGN-103 just like where you’ve been talking about. We’ll move 103 into high-grade disease. We’ll look at other areas where we can study UGN-103. There may be other populations, and it may be not just in the newly diagnosed intermediate risk, but there may be a population, the unwilling and unable population, which is actually broader than just the intermediate risk. And that’s something that I’ve been wanting to do for the last few years. So, maybe we take an opportunity to do that, and that would include newly diagnosed across a broader spectrum of patients that physicians just don’t want to or patients don’t want to go to surgery.

But it’s a great question. We’ll have to give it some more thought from that perspective.

Leland Gershel: And I’ll just actually slip in a quick second just in terms of pipeline following the recent update on ICVB-1042 and other collaborative agreements. Just wondering if you have any plans to share more there either data or more about the collaborations in 2025 and also 301 if we might see more reveal from that ongoing development? Thank you.

Liz Barrett: Yes. No, great question. On the collaborations, I think we will wait till we see some data, some feasibility data. These are early studies. They’re really the first question is, can you put the drug in the gel? Does it work? Does it provide the benefit that we think it does? So, we’ll do some preclinical work there. But absolutely, if that moves forward, we will share that. And then Mark, do you just want to give an update on what we expect that we’ll see this year for UGN-301 and 1042?

Mark Schoenberg: Yeah, thanks. So, with respect to 1042, this year is IND enabling studies, so we’ll be focused on that formulation, obviously, we have notable output from that we would share that. But as Liz points out, it’ll probably be next year before we have substantive data to share and it’s early in that program. With respect to 301, we did announce the monotherapy data at the SCO this past year. We actually as everyone knows have combination arms in that trial, which is a Phase 1 trial combining 301 with our TLR7 agonist 201 as well as with gemcitabine. We have seen some interesting data with respect to responses. Again, it’s a Phase 1 trial, but we are following those patients for the durability of those responses and anticipate reporting that later this year.

Operator: Our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.

Paul Choi: Hi, thank you. Good morning and thanks for taking our questions. I want to revisit pricing for 102 for a moment. And I just want to ask given the impressive durability that the ENVISION data has shown relative to the total all in cost for [indiscernible]. Have you sort of stress tested maybe potentially higher pricing and just sort of your payer reactions on this for 102 here, just again given the durability and potential long-term reduction in cost? Any color there would be great. And second, with 103 potentially launching as early as 2027, can you comment on how you’re thinking about positioning 102 versus 103? Would there be a switch strategy? Or would you just of fade out 102 in favor of 103 given the longer IP considerations there? And just how you’re thinking about the potential return on 102 if you do think about a switch strategy? Thank you very much.

Liz Barrett: Yes, great questions, Paul. And I can tell you that we are revisiting. There’s research underway because the pricing research we had done was before the impressive data to your point, durability data. So, we are looking at that, and we do believe that there’s an opportunity to increase that slightly. So, we will definitely be looking at that. And I’m sorry, your second question, remind me again.

Paul Choi: Just how you’re thinking about positioning 103 versus 102 apart from IP? And just are you going to fade 102 out? And how you’re thinking about the potential return profile for 102 if you do switch to 103?

Liz Barrett: What we would do is, we would, as soon as 103 is approved, we would likely wait for the J-code to get so there’s no concern about reimbursement. But then after that, we would actually fade out UGN-102, and we would take UGn-102 off the market and shift all of that the business to UGN-103. And that what that provides us is that is that 102 won’t be on the market, so there won’t be any automatic substitution or there won’t be inter interchangeability. So, if a generic or someone came in at post 2031, they would actually have to promote the product, and the doctor would actually have to write for their specific products. So, it wouldn’t be a 102 for them to write, again, it’d be interchangeable. In addition to that, I don’t know if anyone saw, but we had the product specific guidance came out in November around JELMYTO, and the guidance says that they have to demonstrate that it is identical, not equivalent, but identical.

And I think that raises the bar for anyone to come in regardless of whether 102 is on the market or not. And we’re obviously just shifting the information that we have for JELMYTO to UGN-102 because JELMYTO is the only one right now that generics have you know, obviously, since 102 isn’t on the market. But, again, 102 would not be would, you know, would not be on the market for the generic companies to be able to compare to. So, I hope that helps.

Operator: Our next question comes from the line of Aydin Huseynov with Ladenburg. Your line is open. Please go ahead.

Aydin Huseynov: Hi, good morning, everyone. Thank you for taking questions and congrats for the progress this quarter. A question I have is regarding the commercial preparedness and infrastructure. So, I think you mentioned the increase of reps from 52 to 83 and your current reps obviously selling JELMYTO, it’s making $100 million, and potentially, UGN-102, I think your guidance is $1 billion in the peak sales. Can you help us understand the sort of economies of scale of increasing from 52 to 83 given that it’s actually 10 times more potential peak sales? So maybe you can help us understand this from commercial preparedness perspective.

Liz Barrett: Sure, absolutely. David, do you want to comment on that and why we feel like the 83 is an appropriate number even despite the fact that it’s obviously a much bigger opportunity?

David Lin: Yes. That’s a great question. So, our analysis to increase the size of our commercial footprint from about 52 territories to around 83 territories is really hinged on the patient epidemiology. And one important thing to note is that with JELMYTO and the low grade UTUC with something like 6000 patients in a year that might present, the likelihood of any one urologist seeing more than one of these is fairly uncommon. In the case of low grade intermediate risk NMIBC, what we hear from customers is that they are seeing they know who these patients are. And the vast majority of urology practices do see these patients. And so. the sizing of 83 territories allows us to get to the vast majority of treating physicians and practices.

So, it’s something like roughly 85% of the market is covered. So, we are really hitting the sweet spot in learning from our experiences with JELMYTO and that the frequency of our visits does make a difference. And so, we’re increasing that. And importantly, the patients are in these practices. So, we feel very good about the size of our commercial footprint going forward. And it will allow us to see and provide the comprehensive service that we know is required to help them get these patients started and through therapy.

Liz Barrett: Yeah. And the only thing I’ll add is that in addition to the 83 reps, as David talked about, we have nurse educators, we have medical science liaisons for peer to peer, we have operations managers that help with the operational lift and logistics pieces of it, and we’ve got account directors and field reimbursement managers. So, it’s not just the 83. It’s these other roles that we have found to be very critical in the, you know, the really comprehensive support system for physician offices. So given the entire field organization is much greater than 83, we feel really good about the number and where we are.

Operator: Thank you. And I’m showing no further questions at this time, and I would like to hand the conference back to Liz Barrett for any further remarks.

Liz Barrett: Great. Thanks, everybody. I just want to say thank you. It’s been a very busy year in 2024. We’ve already turned the page and 2025 will be the most transformational year for our company. We’re excited about the opportunity for UGN-102 to bring that to patients. And we look forward to providing more updates as things happen throughout the year. So, appreciate everyone joining. We can disconnect now. Thank you.

Operator: Concludes today’s conference call. Thank you for participating, and you may now disconnect. Everyone, have a great day.