UroGen Pharma Q4 2024 Earnings Call Transcript

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March 10, 2025
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Operator

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the Urogen Pharma Fourth Quarter and Full Year twenty twenty four 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
Vincent Perrone
Senior Director of Investor Relations at UroGen Pharma

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's fourth quarter and full year twenty twenty four 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 12/31/2024. 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 Chief Executive Officer Doctor.

Vincent Perrone
Vincent Perrone
Senior Director of Investor Relations at UroGen Pharma

Mark Schoenberg, Chief Medical Officer David Lin, Chief Commercial Officer and Chris Stegdon, 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 JELMIO, 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-one hundred and two if approved, anticipated data, regulatory filings and decisions, UGN-one hundred and two being the primary growth driver for UroGen if approved future R and D efforts, 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.

Vincent Perrone
Vincent Perrone
Senior Director of Investor Relations at UroGen Pharma

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
Liz Barrett
President & CEO at UroGen Pharma

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-one hundred and two, 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 innovative therapy to patients. At the same time, we continue to generate compelling clinical data that reinforces UGN-one hundred and two safety, efficacy and paradigm changing potential.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

Our commercial product JEMI to continues to grow 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 three trial that serves as a foundation for the UGM-one hundred and two 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 seventy nine point six percent and the twelve month duration of response was an unprecedented eighty two point three percent by Kaplan Meier analysis.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

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 eighteen month duration of response data from Envision and note that these results remain consistent with our previous Kaplan Meierin estimate. With 101 patients now followed for at least eighteen months following CR or twenty one months post therapy start, the updated duration of response is eighty point six percent by Kaplan Meier analysis. The median follow-up time for these patients has now extended to eighteen point seven months after three months CR, up from 13.8 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 one hundred and twenty day update and they will be part of the submission.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

The durability of response is critical for a disease with historically high recurrence rate. By extending disease free periods, UGM-one hundred and two 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.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

We aligned with the agency that the advisory committee presentation and materials were focused on the recurrent patient population studied in the ENCISION trial. Therefore, we believe that UGM-one hundred and two, 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 UGM-one hundred and two 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.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

If approved, UGM-one hundred and two will become the first medicine for this patient population, introducing a potentially paradigm shifting solution for this disease. An approval of UGM-one hundred and two will be transformative for UroGen as it represents a significant market opportunity, a population nearly 10 times larger than the market for gel mito. This translates to a total addressable market of more than $5,000,000,000 Importantly, our ability to identify and target physicians and their patients for UGM-one hundred and two will be easier. Unlike low grade upper tract 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. UGM-one hundred and two is designed for seamless integration into outpatient practice workflows.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

The ease of use creates the opportunity for physicians to expand their practices and enhance patient care. JALMIDO generated net product revenues of $90,400,000 for the full year twenty twenty four compared to $82,700,000 for the prior year. The increase of $7,700,000 year over year was primarily driven by increased underlying demand for Jalmyto, partially offset by a decrease in Creates X 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.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

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 twenty twenty four, we saw our highest ever number of demand units. David Lim 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 ICVB1042 from econovir. This next generation investigational oncolytic virus represents an exciting opportunity in cancer care.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

With its unique mechanism, ICVB1042 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 $241,700,000 in cash, cash equivalents and marketable securities.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

We remain well capitalized to execute our operating plan and advance the company to and through profitability with the anticipated launch of UGM-one hundred and two later this year. I will now turn the call over to Mark Schonberg, our Chief Medical Officer for a clinical update. Mark?

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

Thank you, Liz. Beginning with the NDA for UGN-one hundred and two, our clinical and regulatory teams are fully engaged in preparing for the ODAC meeting where UGN-one hundred and two 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-one hundred and two 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.

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

And UGN-one hundred and two 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-one hundred and two continues to grow. Liz highlighted the latest duration of response data from Envision showing an impressive 80.6% duration of response at 18 for those patients who had achieved a complete response at 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.

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

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 GelMIDO. These data further reinforced GelMido'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 GelMaito were published in urologic oncology. This long term study evaluated 56 patients from 15 high volume centers who achieved complete responses with GelMida demonstrating a recurrence free survival rate of sixty eight percent at three years.

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

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 GelMido in a broad patient population. Turning now to the pipeline, we have a comprehensive life cycle management plan for GelMido and UGN-one hundred and two. Enrollment continues in the Phase III Utopia trial, which is evaluating UGN-one hundred and three, 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.

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

Low grade intermediate risk disease patients with recurrent disease are receiving UGN-one hundred and three via intravascular 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-one hundred and four, our next generation formulation of gel mito and expect to commence a single arm Phase three study in the first half of twenty twenty five. In February, we were pleased to announce the acquisition of ICVB ten forty two, a next generation oncolytic virus developed by Iconovir.

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

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 anti tumor immune response. Ten forty two 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 ten forty two 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 ten forty two potential to address a broader range of malignancies beyond the genitourinary space.

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

Finally, UroGen will have a significant presence at this year's American Urology Association meeting to take place April '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 Doctor. Sandeep Prasad, the Principal Investigator of the UGN-one hundred and two trial. Now over to David Lin for a commercial update.

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

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-one hundred and two. The upcoming launch would mark a pivotal moment in UroGen's evolution from a rare disease focused company to a multi product 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.

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

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-one hundred and two. 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 are focused on three key priorities in our pre approval 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-one hundred and two.

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

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 JALMAYDO. And finally, we are scaling our commercial infrastructure and capabilities to ensure we're appropriately sized to fully address the opportunity for UGN-one hundred and two 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-one hundred and two into treatment protocols.

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

Additionally, we are preparing our engagement initiatives to inform both clinical practices and patients about UGN-one hundred and two's coverage options and reimbursement. While 2 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-one hundred and two 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 GelMido, as Liz mentioned, the product delivered $87,400,000 in underlying demand revenue in 2024, an increase of 12% versus the prior year.

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

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 3313% 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 JELMIDO. These results continue to reinforce its important role in treating low grade upper tract urothelial cancer.

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

We are continuing our high touch strategy with a focused effort on key accounts, ensuring JELMIDO remains a key part of our commercial portfolio. As we expand our sales force in preparation for the UGN-one hundred and two launch, the new representatives will also be promoting JELMIDO. 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
Chris Degnan
CFO at UroGen Pharma

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 $241,700,000 providing a solid foundation to continue executing on our strategic initiatives. With the anticipated launch of UGN-one hundred and two 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.

Chris Degnan
Chris Degnan
CFO at UroGen Pharma

Gelm Lytle net product revenues were $24,600,000 in the fourth quarter of twenty twenty four compared to $23,500,000 for the same period in 2023. Underlying demand revenue increased by 15%, partially offset by decrease in Creates Act sales, which totaled $200,000 in the fourth quarter of twenty twenty four compared to $2,400,000 for the same period in 2023. Gelmido net product revenues for the full year ended 12/31/2024 were $90,400,000 compared with $82,700,000 of revenue in 2023. Research and development expenses for the fourth quarter of twenty twenty four were $14,900,000 as compared to $11,300,000 for the same period in 2023. R and D expenses for the full year 2024 were $57,100,000 compared with $45,600,000 for 2023.

Chris Degnan
Chris Degnan
CFO at UroGen Pharma

The year over year increase was primarily driven by manufacturing expenses for our product candidates, regulatory expenses related to UGN-one hundred and two and costs associated with the UGN-one hundred and three Utopia trial. SG and A expenses for the fourth quarter of twenty twenty four were $34,900,000 compared to twenty four point six million dollars in the same period in 2023. For the full year 2024, SG and A expenses were $121,200,000 compared with $93,300,000 in 2023. The year over year increase was primarily driven by UGN-one hundred and two commercial preparation activities. We reported non cash financing expense related to the prepaid forward obligation to RTW investments of $6,100,000 in the fourth quarter of twenty twenty four compared to $5,500,000 in the same period in 2023.

Chris Degnan
Chris Degnan
CFO at UroGen Pharma

Non cash financing expense related to RTW investments was $23,400,000 in the full year 2024 compared with $21,600,000 in 2023. Interest expense related to the outstanding $125,000,000 term loan facility with Pharmacon Advisors was $3,900,000 and $12,500,000 respectively for the fourth quarter and full year 2024 compared with $3,600,000 and $14,700,000 respectively for the fourth quarter and full year 2023. Net loss was $37,500,000 or $0.8 per basic and diluted share in the fourth quarter of twenty twenty four compared with a net loss of $26,000,000 or $0.72 per basic and diluted share in the same period in 2023. For the full year 2024, net loss was $126,900,000 or $2.96 per basic and diluted share compared with a net loss of 102,200,000 or $3.55 per basic and diluted share in 2023. Turning to forward guidance for 2025.

Chris Degnan
Chris Degnan
CFO at UroGen Pharma

The company expects full year 2025 Gelmido revenues to be in the range of $94,000,000 to $98,000,000 This implies a year over year growth rate of approximately 8% to 12% over the $87,400,000 in demand driven Gelmito revenues in 2024, which excludes the $3,000,000 in Createx sales reported in 2024. Full year 2025 operating expenses are expected to be in the range of $215,000,000 to $225,000,000 including non cash share based compensation expense of $11,000,000 to $14,000,000 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-one hundred and two launch as well as the advancement of our UGN-one hundred and three and UGN-one hundred and four clinical programs. We are now ready to open the call for questions. Operator?

Operator

Thank you. And our first question is going to come from the line of Terry Bancroft with TD Cowen. Your line is open. Please go ahead.

Analyst

Great. Thanks. This is Nik on for Tara. You noted on the call that you anticipate approval in the recurrent setting. Do you anticipate that UGN-one hundred and two could still be used in the about ten percent of patients or so that are ineligible for surgery, which would be at the frontline setting?

Analyst

And would this then require to be used off label? Thanks.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

Yeah. Hi, Nick. It's Liz. Yeah. I think that would be considered off label.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

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 is really more of a situation of making sure that they can get paid for it. So as we've talked about before, we thought 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.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

And it doesn't change our revenue projections and be really clear about that. So we still believe that the Medicine 01/2002 will be over $1,000,000,000 revenue. And that doesn't change that. And it never did. It was more of exactly what you're talking about.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

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 it's a little bit more risky, but and physicians have told us they would like to be able to make that choice and not the FDA.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

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 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 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 also think about whether we should do some clinical work in this space or not.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

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.

Analyst

That's very clear. Thank you very much.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

Thanks, Cinc.

Operator

Thank you. And one moment for our next question. Our next question will be coming from the line of Michael Schmidt with Guggenheim. Your line is open. Please go ahead.

Michael Schmidt
Senior Managing Director & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC

Hey, good morning. Thanks for taking our questions. On 2, as you think about the potential FA approval later this summer in June, How should investors think about the initial launch trajectory perhaps relative to Gelmido or other potential benchmarks? Are there any analogs that we should

Michael Schmidt
Senior Managing Director & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC

look

Michael Schmidt
Senior Managing Director & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC

at? And then, yes, how should we think about pricing again of one or two relative to JELMIDO? And would you expect any meaningful channel inventory builds early this year?

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

Thanks for the question. I'll turn it over to David Lin, our Chief Commercial Officer, to answer those questions. David?

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

Yes. Thanks for the question. In terms of launch trajectory, we intend to like we mentioned, we're going 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 GelMido. While the absolute numbers would be larger because of the patient population, The overall shape we are modeling very similar to that of Gel Myo because there's a lot of similarities in terms of the operational considerations.

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

On your question with regard to pricing, I think we've been we continue to think of pricing in the eighteen thousand dollars 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.

Michael Schmidt
Senior Managing Director & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC

Great. Thank you. Thank

Operator

you. One moment as we move on to the next question. Our next question is going to come from the line of Regal Ram Selvaraju with CHC Wainwright. Your line is open. Please go ahead.

Raghuram Selvaraju
Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC

Thanks so much for taking our questions. Firstly, with respect to UGN-one hundred and two 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 will have the generic J code and once you actually have the specific J code in January of twenty twenty six, 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-one hundred and three 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.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

Yes, great question. So I'll ask David to answer the first question around reimbursement and then move to Mark to give you an update on UGM-one hundred and three and timing. So David?

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

Yes. Thanks again for the question there. 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 fifty day to sixty days for a provider to be reimbursed.

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

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 our broader audience.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

Well, let me I just want to add a couple of things. We will have services to get physicians through that time period. So like we did with JALMAYDA, we'll have a 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 Jomayto, that the initial uptake from a CytoCare 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 the J code becomes more challenging is really the private practices who are therapy at that place.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

So again, as the therapy at that place. So again, as we mentioned earlier, as David mentioned earlier, I think you can look at JALMAYDO in the initial couple of first eighteen months. I would not look at John Mito post those eighteen months because we do believe that the opportunity is far greater for UGM-one hundred and two and we should see an acceleration that's greater than we see with John Mito. But the first couple of years of John Mito, if you see, in our first year, we sold 15 mill around the same six months, almost $15,000,000 in revenue and then it went up to almost $50,000,000 in the full year following. So I would use that as a good analog for the first eighteen months.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

So hopefully that helps.

Raghuram Selvaraju
Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC

Well, what I would also mention, of course, is for those who remember, you launched GelMido in the middle of a pandemic and that will clearly not be the case with 01/2002.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

Exactly. Absolutely. But 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 a little bit less, but you can see at 10 times the size, even if JALMIDA were the analog, it would still be a very positive for the first few months of the launch. But you're absolutely right.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

We launched into a pandemic and hopefully, and now come with everybody, we won't be having a pandemic in 2025 and 2026. So thanks for the question and the comment as well. And then I'll turn it over to Mark to answer the question on 01/2003. Mark?

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

Yes. Thanks, Liz. With respect to 01/2003 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 to be able to keep to that timeline.

Raghuram Selvaraju
Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC

Thank you very much.

Operator

Thank you. And one moment as we move on to the next question. And our next question is going to come from the line of Leland Gershault with Oppenheimer. Your line is open. Please go ahead.

Leland Gershell
MD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.

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 if 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
Liz Barrett
President & CEO at UroGen Pharma

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 UGM-one hundred and three is that we would be moving to our patent protection on that medicine will be until through 02/1941.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

So we have a lot of time. So I think we would take a look at it, but no, we would not amend the current 01/2003. And the reason we would not amend the 103 is because we need to keep that study as close to UGM-one hundred and two as possible. So that 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 UGM-one hundred and two.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

So you want to keep that study as quickly as possible. But we'll evaluate UGM-one hundred and three 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 UGM-one hundred and three. 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.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

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 Gershell
MD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.

Thanks. And I'll just actually slip in a quick second just in terms of the pipeline following the recent update on ICDB-one hundred and two, 01/1942 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 03/2001 if we might see more reveal from that ongoing development? Thank you.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

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?

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

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-three zero one and October?

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

Yes, thanks. So with respect to October, this year is IND enabling studies. So we'll be focused on that formulation, etcetera. And obviously, we have notable output from that. We would share that.

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

But as Liz points out, it will probably be next year before we have substantive data to share. And it's early in that program. With respect to 03/2001, we did announce the monotherapy data, the SEO this past year. We actually, as everyone knows, have combination arms in that trial, which is a Phase one trial combining three zero one with our TLR7 agonist two zero one, as well as with gemcitabine. We have seen some interesting data with respect to responses.

Mark Schoenberg
Mark Schoenberg
Chief Medical Officer at UroGen Pharma

Again, it's a Phase one trial, but we are following those patients for the durability of those responses and anticipate reporting that later this year.

Leland Gershell
MD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.

Super. Thanks very much.

Operator

Thank you. And one moment as we move on to the next question. 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
Paul Choi
Analyst at Goldman Sachs

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 costs for repeat turbits, have you sort of stress tested maybe potentially higher pricing and just sort of your payout reactions on this for 102 here, just again given the durability and potential longer term reduction in costs, any color there would be great.

Paul Choi
Paul Choi
Analyst at Goldman Sachs

And second, with 103 potentially launching as early as 2027, can you comment on how you're thinking about positioning one hundred and two versus one hundred and three? Would there be a switch strategy? Or would you just sort of fade out one hundred and two in favor of one hundred and three 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
Liz Barrett
President & CEO at UroGen Pharma

Yes, great questions, Paul. And I can tell you that we are revisiting. We had already 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.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

And I'm sorry, your second question, remind me again.

Paul Choi
Paul Choi
Analyst at Goldman Sachs

Yes, sure, Liz. Just how you're thinking about positioning 103 versus 102 apart from IP and just are you going to state it out 102 out and just how you think about the potential return profile for 01/2002 if you do switch to 103?

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

Yes, absolutely. Sorry. But yes, what we would do is we would as soon as 103 is approved, we would likely wait for the J code, right, to get so there's no concern about reimbursement. But then after that, we would actually fade out UGM 102 and we would take UGM 102 off the market and shift all of that the business to UGM 103. And that what that provides us is that 102 won't be on the market, so there won't be any automatic substitution or there won't be inter changeability.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

So if a generic or someone came in at post 2,031, 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 and 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 JALMAYDO 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 Jomito to UGM-one hundred and two because JYALMIDO is the only one right now that generics have obviously since 102 isn't on the market.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

But again, 102 would not be on the market for the generic companies to be able to compare to. So hope that helps.

Paul Choi
Paul Choi
Analyst at Goldman Sachs

Got it. Okay. Thank you very much. Thanks. Thanks, Paul.

Operator

Thank you. And one moment for our next question. Our next question comes from the line of Aden Husanov with Ladenburg. Your line is open. Please go ahead.

Aydin Huseynov
Equity Research Analyst at Ladenburg Thalmann & Co. Inc

Hi, good morning, everyone. Thank you for taking questions and congrats with the progress this quarter. Question I have is regarding the preparedness commercial preparedness and infrastructure. So I think you mentioned the increase of reps from $52,000,000 to $83,000,000 and your current reps obviously selling JoeMaidos making $100,000,000 And potentially, Eugene, in 01/2002, I think your guidance is $1,000,000,000 in the peak sales. So 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.

Aydin Huseynov
Equity Research Analyst at Ladenburg Thalmann & Co. Inc

So maybe you can help us understand this from commercial preparedness perspective.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

Sure. Absolutely. David, do you want to comment on that and why we feel like the 83 is an

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

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 Gelmido and the low grade UTUC, with something like six thousand 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 markets covered.

David Lin
David Lin
Chief Commercial Officer at UroGen Pharma

So we are really hitting the sweet spot in learning from our experiences with Joe might have and that the frequency of our visits does make a difference. And so we are 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
Liz Barrett
President & CEO at UroGen Pharma

Yes. 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 and the really comprehensive support system for physician offices. So given the entire field organization is much greater than eighty three, we feel really good about the number and where we are.

Aydin Huseynov
Equity Research Analyst at Ladenburg Thalmann & Co. Inc

Thank you. Thanks so much.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

Thank you.

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
Liz Barrett
President & CEO at UroGen Pharma

Great. Thanks, everybody. Just want to say thank you. It's been a very busy year in 2024. We've already turned the page in 2025.

Liz Barrett
Liz Barrett
President & CEO at UroGen Pharma

We'll be the most transformational year for our company. We're excited about the opportunity for UTM102 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

This concludes today's conference call. Thank you for participating and you may now disconnect. Everyone have a great day.

Executives
    • Vincent Perrone
      Vincent Perrone
      Senior Director of Investor Relations
    • Liz Barrett
      Liz Barrett
      President & CEO
    • Mark Schoenberg
      Mark Schoenberg
      Chief Medical Officer
    • David Lin
      David Lin
      Chief Commercial Officer
    • Chris Degnan
      Chris Degnan
      CFO
Analysts
    • Analyst
    • Michael Schmidt
      Senior Managing Director & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC
    • Raghuram Selvaraju
      Managing Director, Healthcare Equity Research at H.C. Wainwright & Co., LLC
    • Leland Gershell
      MD & Senior Biotechnology Analyst at Oppenheimer & Co. Inc.
    • Paul Choi
      Analyst at Goldman Sachs
    • Aydin Huseynov
      Equity Research Analyst at Ladenburg Thalmann & Co. Inc
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Key Takeaways

  • NDA submission for UGN-102 was filed ahead of schedule and granted a PDUFA target date of June 13, 2025, supported by Envision Phase 3 data showing a 79.6% complete response at 3 months and 80.6% durability at 18 months (median not reached).
  • UroGen expects UGN-102 to address a $5 billion total addressable market for recurrent intermediate-risk, low-grade NMIBC, with an ODAC advisory committee meeting slated for May.
  • JELMYTO net product revenues reached $90.4 million in 2024 (up 12% in underlying demand), driven by record Q4 demand units and an expanded footprint of prescribers and sites.
  • Pipeline progress includes the Utopia Phase 3 trial of UGN-103 (topline data anticipated in 2026, launch in 2027), a Phase 3 study for next-generation gelmibido (UGN-104) starting H1 2025, and the acquisition of ICVB1042, a next-gen oncolytic virus.
  • UroGen ended 2024 with a strong balance sheet of $241.7 million in cash and equivalents, positioning the company to fund its UGN-102 launch and advance its pipeline toward profitability.
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Earnings Conference Call
UroGen Pharma Q4 2024
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