Urogen Pharma Ltd

NASDAQ:URGN

Earnings Call Analysis

UroGen Pharma Progresses with UGN-102 and Reports Strong Q3 Results

UroGen Pharma showcased its advancements, particularly with UGN-102, aimed at treating non-muscle invasive bladder cancer. Following the FDA's acceptance of the NDA with a target date of June 30, 2025, UGN-102 could notably improve treatment outcomes with a large, untapped market of over 80,000 patients annually in the U.S. Revenue from JELMYTO reached $25.2 million, a 21% increase year-over-year, despite challenges. The company anticipates low double-digit growth for JELMYTO in 2024. With cash reserves of $254 million, UroGen appears well-positioned to support its operational strategies leading up to the upcoming product launch.

A Transformative Moment for UroGen Pharma

UroGen Pharma is at a pivotal point in its journey as it progresses toward potentially launching UGN-102, a groundbreaking therapy for treating low-grade intermediate risk non-muscle invasive bladder cancer. The company recently submitted a New Drug Application (NDA) for UGN-102, which has been accepted by the FDA, setting a target decision date (PDUFA) for June 13, 2025. This achievement is not merely regulatory; it underscores UroGen's commitment to changing treatment paradigms for bladder cancer and the significant market opportunity ahead.

Robust Revenue Growth Despite Challenges

In the third quarter of 2024, UroGen reported net product revenues of $25.2 million for JELMYTO, representing a 21% increase year-over-year. This growth was driven by robust patient demand and key account engagement, with new patient enrollments rising over 30%. However, the revenue growth faced headwinds from gross-to-net erosion linked to factors like the Medicare wastes provision and increased 340B drug pricing program utilization. Despite these challenges, the management anticipates JELMYTO will deliver low double-digit revenue growth for the full year.

Significant Pipeline Advancements

UGN-102, if approved, would represent a considerable advancement in bladder cancer treatment, with an addressable annual patient population exceeding 80,000 in the U.S. This market is estimated to be around $5 billion—approximately ten times larger than the current market for JELMYTO. The company successfully launched a Phase III clinical trial (UTOPIA) for UGN-103, further expanding its pipeline for bladder cancer therapies. Management believes that UGN-102 will seamlessly fit into existing urologic practice workflows, making it more accessible to doctors and patients.

Financial Overview and Future Guidance

During the call, CFO Chris Degnan reported a net loss of $23.7 million for Q3 2024, compared to a loss of $21.9 million in the same quarter last year. UroGen's balance sheet remains strong, with $254.2 million in cash and equivalents, indicating sufficient capital to support its business objectives through the anticipated product launches. For 2024, the company's total operating expenses are projected to be around $175 million to $185 million, aligning with ongoing commercialization efforts for UGN-102, along with a non-cash financing expense expected to be between $21 million and $26 million.

Strategic Preparation for Launch

UroGen is actively preparing for the commercial launch of UGN-102, scaling its sales force from approximately 42 representatives to over 80 by launch time. This expansion is aimed at increasing interaction and support for providers, which has proven effective with JELMYTO. The focus is on education and operational integration support to ensure successful adoption in the market. As the company transitions to this broader market, they emphasize minimizing potential barriers with reimbursement processes through comprehensive support for healthcare professionals.

Emphasis on Regulatory Engagement

The FDA's decision for a standard review rather than a priority designation was notable, with UroGen's leadership fully preparing for an upcoming advisory committee (ODAC) meeting. Scheduled ahead of the PDUFA date, this meeting could crucially shape the positioning of UGN-102 in the market. The company expects robust engagement with the FDA's process, as the agency aims to gather insights regarding UGN-102's innovative treatment model, which presents a significant improvement in managing non-muscle invasive bladder cancer.

Earnings Call Transcript 2024-Q3

[Operator]

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the UroGen Pharma Third Quarter 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. You may now begin.

[Vincent Perrone, executive]

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's Third Quarter 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 quarter ended September 30, 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; Dr. Mark Schoenberg, Chief Medical Officer; 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 future commercialization activities for UGN-102 have approved. Anticipated data, regulatory filings and decisions, UGN-102 being the growth driver for UroGen if approved. Future R&D efforts, our corporate goals and 2024 financial guidance among other things. These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. We 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 Barrett.

[Elizabeth Barrett, executive]

Thank you, Vincent, and thank you for joining us this morning. As we continue to innovate and pioneer new treatment paradigms in urothelial cancers, I'm excited to highlight the progress we've made with UGN-102, our groundbreaking therapy for low-grade intermediate risk non-muscle invasive bladder cancer ahead of schedule, we successfully submitted the new drug application for UGN-102 in August. And in October, we were pleased to announce the FDA's acceptance of the NDA with a PDUFA target date of June 13, 2025. This milestone represents more than a regulatory achievement. It is a testament to the dedication of our team and a pivotal step toward our goal of changing how low-grade intermediate risk non-muscle invasive bladder cancer is treated.

Our regulatory and clinical teams are committed to working closely with the FDA during the review process as we move toward a potential approval. Meanwhile, we are initiating our pre-commercial activities to position ourselves for a robust launch with the ability to deliver UGN-102 to patients at the earliest opportunity. David will provide more details on this shortly. If approved, UGN-102 will become the first FDA-approved medicine for this patient population, introducing a novel solution that could significantly reduce recurrent rates while extending the time between treatment. UGN-102 aligns our commitment to enhancing patient outcomes and reshaping treatment paradigms in neurologic oncology. The market opportunity for UGN-102 has the potential to be transformative for our company with more than 80,000 addressable patients annually in the U.S. This market is approximately 10x larger than the market JELMYTO currently serves and represents an estimated total addressable market of over $5 billion.

In contrast to the JELMYTO market opportunity and low-grade upper tract urothelial carcinoma, which is a rare disease, which is dispersed and episodic. Low-grade intermediate risk non [indiscernible] invasive bladder cancer is widespread and regularly managed by nearly all urologists. UGN-102 is straightforward to administer and integrate seamlessly into existing outpatient practice workflows without the need for special equipment. JELMYTO delivered $25.2 million in net product revenue for the third quarter, representing a 21% year-over-year increase. The revenue reflected strong underlying patient demand but also included $2.6 million from [ Create XL ] in Q3 of 2024 and compared to $1.1 million in the same period in 2023.

Recognizing the high-touch nature of this product, we strategically focused on increasing our reach and frequency with key accounts in the quarter. which we believe is contributing to improved demand growth in the third quarter compared to the first half of this year. In fact, new patient enrollments in Q3 increased over 30% versus prior year, representing an all-time high since launch. Similarly, we continue to drive a healthy increase in new prescribers up over 30% versus a year ago. We are seeing signs of continued momentum in early Q4 and expect to be able to deliver low double-digit revenue growth for JELMYTO for the full year 2024. Despite the gross to net headwinds we variance in recent quarters.

Looking ahead, at the core of Urogen's life cycle management strategy is ensuring the long-term success and growth of our uro-oncology franchise. In September, we announced receipt of a notice of allowance from the U.S. Patent and Trademark Office for a patent covering key technology used in the development of UGN-103 and UGN-104, our next-generation therapies for UGN-102 and JELMYTO, respectively. Upon issuance, the patent will extend through December of 2021 and and cover the innovative combination of our proprietary RTGel technology with a unique mitomycin formulation licensed from MEDAC. This is a critical step in strengthening our intellectual property portfolio and providing life cycle management that extends our franchise for the long term.

Dosing in the Phase III utopia trial for UGN-103 commenced in early October demonstrated continued momentum in our clinical development. Mark will provide further details on this exciting progress.

In October, we appointed Chris Degnan as Chief Financial Officer. Chris has extensive CFO experience with publicly traded biotech companies, most recently at [ Galera Therapeutics and Berica Pharmaceuticals ]. He has also held senior positions at [ Endo ] International and worked at AstraZeneca for more than 10 years. He has broad expertise and financial strategy, Investor Relations, SEC reporting, accounting and compliance. I want to take this opportunity to formally welcome to [ Chris Degnan ]. He is joining us on the call today and will provide financial results for the quarter shortly. Chris' appointment is part of the broader initiative to enhance our leadership team as we prepare to commercialize UGN-102 and take UroGen to the next stage of growth. We also welcome David Lin as our new Chief Commercial Officer in June. I will now turn the call over to Mark Schoenberg, our Chief Medical Officer, for a clinical update. Mark?

[Mark Schoenberg, executive]

Thank you, Liz. I want to begin by echoing Liz's sentiments regarding the FDA's acceptance of our NDA for UGN-102. This is a significant milestone for our company. Our regulatory and clinical teams look forward to collaborating closely with the agency through our review process. The UGN-102 NDA is supported by a robust and comprehensive development program that demonstrated a clinically meaningful complete response rate and a strong duration of response across three late-phase clinical trials, along with an acceptable safety profile. The Phase III ENVISION trial, which serves as the pivotal trial for the NDA successfully met its primary endpoint, demonstrating a 79.6% complete response rate at 3 months after the first installation of UGN-102. More recently, durability data from ENVISION revealed an impressive 82.3% 12-month duration of response by Kaplan-Meier analysis in patients who had achieved a complete response of 3 months. Notably, this represents the highest duration of response that were reported in this patient population.

I am also pleased to report that the long-term durability data from the ENVISION trial were recently published online in the Journal of Urology. The article will appear in print early next year. As we have communicated, we are anticipating an advisory committee and are proactively preparing for this meeting. The FDA has not notified us of the timing, but we expect to receive notification early in 2025. If approved, we believe UGN-102 will represent a significant advancement in the treatment of low-grade intermediate risk non-muscle invasive bladder cancer.

Turning now to the pipeline, as Liz mentioned, we have a comprehensive life cycle management plan for JELMYTO and UGN-102. In October, we announced the dosing of the first patient in the Phase III clinical trial evaluating UGN-103, treatment of low-grade intermediate risk non-muscle invasive bladder cancer. The UTOPIA trial is a single-arm Phase III multicenter study designed to evaluate the efficacy and safety of UGN-103. Our goal is to enroll 87 patients. The study protocol mirrors that of the ENVISION trial with low-grade intermediate risk NMIBC patients with recurrent disease receiving UGN-103 via intravesical installation once a week for 6 weeks. Efficacy will be assessed based on the complete response rate at the 3-month mark. Patients assuming a complete response, defined as having no detectable disease in the bladder at this visit will enter a follow-up period during which they will return to the clinic every 3 months for ongoing evaluation of duration of response. We anticipate filing the new drug application with the FDA in 2026 and and if approved, the commercial launch in 2027.

We foresee a similar development plan for UGN-104, our next-generation formulation of JELMYTO and expect to commence a single-arm Phase III study early next year.

Turning to our high-grade bladder cancer pipeline. We continue to develop our immuno-oncology candidate, UGN-301. UGN-301 is an anti-CTLA-4 antibody delivered using our proprietary RTGel technology. We are conducting a Phase I clinical study to evaluate safety, tolerability and to establish a recommended Phase II dose for UGN-301. We will present an update of our UGN-301 program at the upcoming Society of Urological Oncology meeting. scheduled for December 4 through 6 in Dallas. Additional abstracts were accepted for poster presentation, including the envisioned duration of response data and long-term follow-up results from the Jelmyto Olympus trial. This year's meeting promises to be particularly productive for our team. And now over to David Lin for a commercial update. David?

[David Lin, executive]

Thank you, Mark. Good morning, everyone. As we focus on the journey ahead with UGN-102, my top priority continues to be preparing UroGen for an anticipated commercial launch in 2025. With the target PDUFA date of June 30, 2025, now established, we have a clear time line for potential approval and launch. Our immediate priority is executing a robust pre-commercial strategy that will establish a solid foundation for making UGN-102 accessible to the medical community and driving widespread adoption. We are confident in the strength of our clinical data and the transformative opportunity it presents to enhance outcomes for patients with low-grade intermediate risk non-muscle invasive bladder cancer.

The launch of UGN-102 would mark UroGen's evolution from a rare disease-focused organization to a specialty-focused multiproduct team. We are scaling our commercial capabilities including patient support and distribution infrastructure. Importantly, we plan to expand our sales force from approximately 42 reps to over 80 at launch. A significant factor in our decision to expand our sales force stems from a learnings and experiences with JELMYTO. We have learned that more engagement from our sales and support teams leads to more effective responses from clinical practices.

To that end, we are committed to having an appropriately sized field force in place by the launch of UGN-102. Our updated launch plan is designed to significantly increase the frequency of interactions with targeted physicians, ensuring we maximize our impact in the market. At the same time, we are actively advancing our prelaunch activities for UGN-102. Our focus includes education through various programs aimed at raising awareness of the unmet need in low-grade intermediate risk non-muscle invasive bladder cancer. While our medical affairs team is also sharing our clinical data to appropriately communicate the value proposition ahead of approval.

To facilitate the integration of UGN-102 into treatment protocols we will provide comprehensive support, including training for health care professionals and their office staff. Additionally, we are implementing engagement initiatives to inform both clinical practices and patients about UGN-102 coverage options and reimbursement. It's important to note that upon approval, UGN-102 will initially be assigned a miscellaneous J-code for billing, which is standard for new drugs. Based on the June 2025 PDUFA date, we would expect to secure a unique permanent J-code for UGN-102 by January 2026. While a miscellaneous J-code may pose fewer challenges for hospitals and oncology centers, the permanent J-code is particularly important in the community setting. Throughout this period, we are fully committed to offering robust reimbursement support to help providers navigate the interim coding process smoothly, ensuring integration of UGN-102 is seamless. I will now turn the call over to Chris Degnan to discuss our financials.

[Christopher Degnan, executive]

Thank you, David, and good morning, everyone. Before I get into the financials, I would first like to take a moment to say that I'm thrilled to join UroGen at such a pivotal time for the company. The strength of our pipeline and the significant market opportunities ahead presenting a unique moment for growth and innovation. I'm excited to work with the talented team that we have here to help bring our transformative therapies to patients and drive long-term value for our shareholders.

Turning now to the quarter. As Liz mentioned, JELMYTO net product revenues reached $25.2 million in the third quarter of 2024 compared to $20.9 million for the same period in 2023. Primarily driven by strong underlying demand growth. Our focused efforts to increase our reach and frequency with key accounts generated solid momentum, which positively impacted Q3 results. Volume growth was partially offset by continued year-over-year gross to net erosion due in part to the Medicare wastes provision and growing 340B utilization. The overall gross to net rate for JELMYTO was relatively consistent quarter-over-quarter.

Cost of revenue in the third quarter was $2.5 million compared with $2.4 million for the comparable period in 2023. The slight increase was primarily attributable to the increased volume of sales of JELMYTO, partially offset by certain nonrecurring payments made in connection with our supply arrangement in the prior year. Research and development expenses in the third quarter were $11.4 million compared with $10.2 million for the comparable quarter in 2023. The increase year-over-year was primarily attributable the higher costs related to the initiation of the Phase III UTOPIA trial for UGN-103, partially offset by lower UGN-102 clinical trial costs and costs related to the research into ingredients, scale-up and production efficiency for JELMYTO.

Selling, general and administrative expenses for the third quarter of 2024 were $28.9 million including noncash share-based compensation expense of $2.9 million. This compares to $21.8 million, including noncash share-based compensation expense of $1.8 million for the same period in 2023. The year-over-year increase was primarily driven by UGN-102 pre-commercialization activities. We reported noncash financing expense of $5.9 million in the third quarter relating to the prepaid forward obligation to RTW investments. This compares with $5.5 million in the comparable period in 2023. The increase of $0.4 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.

Interest expense related to the $125 million term loan facility with [ Pharmakon ] Advisors was $2.7 million in the third quarter compared with $3.8 million for the comparable period in 2023. The decrease was primarily attributable to the decrease in the margin interest rate and the related impact to amortization of the discount on the [ Pharmakon ] loan as a result of the amended and restated loan agreement in March 2024. The third tranche of $25 million under the amended and restated loan agreement was funded in late September 2024.

Net loss for the third quarter was $23.7 million or $0.55 per basic and diluted ordinary share as compared to a net loss of $21.9 million or $0.68 per basic and diluted share in the same period in 2023. As of September 30, 2024, we had $254.2 million in cash and cash equivalents and marketable securities. With our four to five balance sheet, we believe we have the requisite cash and capital to execute our business objectives.

Turning to forward guidance. Although we saw strong underlying demand in the quarter, we expect full year JELMYTO revenues to fall below the low end of our previous guidance. However, we do believe that JELMYTO will deliver low double-digit revenue growth for the full year despite the higher-than-expected gross to net headwinds in recent quarters. Regarding 2024 full year operating expense guidance, we now expect operating expenses to be near the midpoint of our previously guided range of $175 million to $185 million including noncash share-based compensation expense of $9 million to $13 million. This outlook reflects the shift in timing of expenditures tied to the PDUFA target date and preparations for the potential commercial launch of UGN-102.

The anticipated full year 2024 noncash financing expense related to the prepaid obligation to RTW investments is unchanged and expected to be in the range of $21 million to $26 million. The rate for the cash component of the RTW obligation will be 13% of global net product sales of JELMYTO in 2024. We are now ready to open the call for questions. Operator?

[Operator]

Thank you. At this time, we will conduct the question-and-answer session. [Operator Instructions]. Our first question comes from the line of Tara Bancroft with TD Cohen.

[Tara Bancroft, analyst]

First of all, congrats on the NDA acceptance. It's really great to see. And I was wondering if you received and got any more clarity from the 72-day letter in writing, perhaps on why the decision was made for standard review? Or aside from the letter, do you have any other insight into that based on your interactions?

[Elizabeth Barrett, executive]

Yes. Thanks, Tara. It's Liz. They didn't say anything about priority review in the letter. They just talked about, obviously, the review questions, which are does ENVISION provide enough data for -- to demonstrate efficacy what's the role of Atlas. And overall, is a profile acceptable. So kind of the typical what you expect the FDA to say at this point in time. We do know from -- just from correspondence with them and in our initial meeting where we did the application review that they had not at that point in time actually reviewed our data. We know they reviewed the portions that we sent in back in January the nonclinical, but they had not yet reviewed the clinical portion.

So look, we can sit here and guess as to why. My view on it is obviously prior if you would have put them against the wall from a timing standpoint. And the argument has always been, well, they can go back to surgery. And we don't think that's a great argument. We actually very much believed that we qualified for priority review, but obviously, they saw it differently. So -- and I think the other thing is we've consistently said that we expect an ODAC. And so I think, again, from a timing perspective, had we gotten priority review, it would have been, I think, a very short period of time for them to prepare. So that's the only sort of guess we have, but nothing -- they didn't even acknowledge one way or the other, the priority versus standard review. I just gave us our timing and then gave us here are your potential review issues and the three that I mentioned.

[Operator]

Our next question comes from the line of Ram Selvaraju with H.C. Wainwright & Co.

[Raghuram Selvaraju, analyst]

Firstly, I was wondering if you could elaborate on a couple of commercial points, particularly the gross to net discounting with respect to JELMYTO and why you expect that not to be a factor for UGN-102?

[Elizabeth Barrett, executive]

Sure. Chris, do you want to take that?

[Christopher Degnan, executive]

Sure, Ram. So the two big headwinds we've been seeing on gross to net, one is 340B and the second is the Medicare wastes provision. With respect to 102, we don't expect the wastes provision to apply just given the yield loss that we see with the mixing of JELMYTO in the size of the kidney relative to be able to use the full dose within the bladder. And then from a 340B pricing perspective, we do expect more utilization over time in the community setting, which should mitigate some of the 340B exposure that we're seeing with JELMYTO.

[Raghuram Selvaraju, analyst]

And then with respect to the commercial preparations for UGN-102, can you maybe give us a sense of how the time line might have shifted with respect to receipt of standard review for the 102 NDA application. And when you expect to incept specific prelaunch activities as you approach the PDUFA date?

[David Lin, executive]

Yes, this is David. The standard review doesn't change consequentially, any major things we're doing in terms of prelaunch education. As we mentioned, our top priority right now is from an organization standpoint, is to educate on the unmet need in non-muscle invasive low-grade intermediate bladder cancer. And our medical teams continue to share the clinical data with providers in the field of uro-oncology. So otherwise, the preparations remain largely intact, which is preparing our infrastructure and our distribution networks to take on a new product that is considerably larger. And as we mentioned, we will be increasing the size of our field team by about 2x by the time we launch UGN-102.

[Raghuram Selvaraju, analyst]

Okay. And then just two very quick additional questions. Firstly, I was wondering if you could comment on the timing with which you expect office action on the patent covering -- the patent application covering the MEDAC formulation of mitomycin that Liz, you mentioned in your prepared remarks.

And also, maybe, Mark, I don't know if you want to comment at this time on what you anticipate the composition of the future AdCom panel to be just on a qualitative basis, but if you had any insights there, that would be much appreciated.

[Elizabeth Barrett, executive]

Why don't you go ahead, Mark. And then...

[Mark Schoenberg, executive]

Yes. Thanks, Ram. So I think the short answer is, while I don't know the composition, my suspicion would be that it would be reflective of other AdComs, particularly reflected by the evaluation of other drugs in this space. So we'd expect some urologists, particularly urologic oncologists would expect with experience in treating this disease surgically. But I imagine there will also be medical oncologists as well and then specialists in Biostatistics. So probably a fairly typical and expected composition of the group, but certainly, some urologic oncologists who have familiarity with non-muscle invasive bladder cancer.

[Elizabeth Barrett, executive]

Yes. Unfortunately, Ram, I don't have an answer to your question around the IP, but we'll -- I'll find it out from the GC and I'll let you know.

[Raghuram Selvaraju, analyst]

Congrats on all the progress, particularly the NDA acceptance very important for the company.

[Operator]

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

[Leland Gershell, analyst]

So just wanted to fill in further on the IP with respect to the total litigation. I wonder if you can give us any time lines with respect to next steps is a [ Markman ] hearing being scheduled or hasn't been scheduled, is you have any visibility on the net maker.

[Elizabeth Barrett, executive]

Yes, Leland, we don't have any additional updates at this point. We're obviously waiting to get our trial date. But typically, what happens is you see that closer to the 30-month mark. So we expect that likely to happen in 2026, but we don't have that information yet. So to be honest with you, we're sort of just moving forward with all of the typical things that we have to do at this point in relation to that. We feel very strongly, I feel very good about our position and where we are and nothing has changed around that. So again, we're just going forward and waiting for the date but preparing and making sure that we're fully prepared for that outcome.

[Leland Gershell, analyst]

Okay. And would the implications be for whatever the outcome is with the JELMYTO. With those carry over to presumably UGN-102 given overlending IP. In other words, if you were to prevail, then presumably, that would ensure the ability for [indiscernible] to 102. Is that a fair conclusion?

[Elizabeth Barrett, executive]

Yes, that's a fair conclusion on that. And the reality of it is until we get an approval, they can't do anything. But yes, we fully expect that to happen. So in addition, a little difference with 102. We do have some other pending patents for UGN-102 that we think will even make that stronger than where we are to just put other things around it. And just keep in mind and remember that for both of them, the next-generation formulation for UGN-102, which is UGN-103 will actually expect approval in '27. So we -- that would actually be on the market before you ever even got regulatory exclusivity was up for UGN-102. So we feel really good about kind of where we are with our patents, feel very strongly about them, but also feel good around the strategy that we've built around it.

[Operator]

Our next question comes from the line of Kelsey Goodwin with Guggenheim.

[Kelsey Goodwin, analyst]

Congrats on all the progress in the last few months. I guess, first from us, when would you expect to hear from the FDA around an ODAC timing or scheduling? Is there a time after which it could be ruled out. And then second, to what extent do you expect impact to the UGN-102 uptake in the initial quarters with the miscellaneous J-code versus the permanent J-code likely in 2026.

[Elizabeth Barrett, executive]

Yes. Great. And nice to talk to you, Kelsey. We -- from the standpoint of your last question on the miscellaneous code, I'll ask David to sort of comment on that. But so David, do you want to take that first?

[David Lin, executive]

Yes. Kelsey, our expectation in terms of that initial period is not unlike a lot of the other drugs that are launched that have that same billing phenomenon. So we expect that some customers may have a little bit more reservation around adopting, but we fully intend to be promoting to be educating and showing them with our reassurance in terms of training and operations of how to manage billing during that cycle. And there's plenty of examples that we can draw on from not only JELMYTO, but also other products that have launched in the space.

[Elizabeth Barrett, executive]

Yes. And I think in addition to that, you -- I think what you would expect is in the beginning, the sites of care, very much like JELMYTO as well. We're more in the hospital than they were in the community setting for that exact reason. To the question around the timing around ODAC, look, I think we've been very clear. We expect an ODAC. We are in full preparation for ODAC. We expect to ODAC -- the agency has been very clear on that from the beginning really driven by the fact that this is a completely new way of treating these patients and they want to hear from key stakeholders. So we expect that to happen.

The timing on it, usually, you see the ODAC 2 to 3 months prior to the PDUFA. So we would expect the ODAC in the April time frame. It could go as late as May. And we expect a 2- to 3-month notice. So if it's May, then we expect to find out by the beginning of March, if it April, maybe the February, beginning of March, depending on when in April. So April, May timing for the actual ODAC, there is the other sort of the next step is our mid-cycle review meeting. We actually do have a meeting with them. And that would be in kind of the January, February time frame. And we will ask at that meeting for an update on the ODAC and expect that we -- at least we'll get some acknowledgment an idea of timing. But just to know we're in full ODAC preparation. We've actually always been welcomed in ODAC. I know that, that sounds odd, but given what we know about users and physicians and practitioners and the way that they think about this. We believe that would actually be helpful for us.

And so we're very much, like I said, in planning mode and excited about the team that we have around us and including the external experts that will be talking at the ODAC on our behalf. The patients that we'll be talking at ODAC on our behalf and believe that physicians and clinicians will actually welcome the opportunity to have a medicine like UGN-102.

[Operator]

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

[Matthew Kaplan, analyst]

Just wanted to follow up on the ODAC. I guess, frequently, ODAC are called if there's some controversy, can you talk a little bit about the buy-in that you have from the FDA on the ENVISION trial design as a single-arm study and how it could suffice further the approval of 102. And is that also -- is there any controversy there with respect to also, I guess, Utopia's Phase III design as very similar designed to the ENVISION study as well.

[Mark Schoenberg, executive]

Matt, it's Mark. Thanks for the question. So I'm going to try to compress a long story into a short answer. But the answer is we had a meeting with the FDA, during which they agreed in writing that ENVISION could potentially support approval of UGN-102, which was, in fact, the gating conversation to the transition from the ATLAS randomized trial to the ENVISION single-arm trial. So we feel quite comfortable that there was a meeting of the minds on that question.

With respect to your sort of larger question about what are the controversies or what might be underlying the need for an ODAC, I think we've also been doing about the idea that UGN-102 present urologists and patients with a potentially paradigm-changing approach to non-muscle invasive bladder cancer. So we believe, and I think with good reason, that the FDA would like to hold a public vetting with experts in the room to talk about what that would mean in terms of the practical application of UGN-102, and its inclusion in the armamentarium currently available to urologists for the treatment of this population of patients.

[Matthew Kaplan, analyst]

Okay. That's very helpful. And then just a question for Chris. With respect to cash runway, how should we think about that? You finished the quarter in a strong cash position. But I guess with the pending launch coming up second half of next year for 102.

[Christopher Degnan, executive]

Yes, Matt, thanks for the question. So we exited with a four to five balance sheet, $254 million in cash, and we believe that we had the requisite cash to get the business to profitability based off of our current business objectives based off of the June PDUFA date.

[Operator]

Thank you. [Operator Instructions]. Our next question comes from the line of Paul Choi with Goldman Sachs.

[Unknown Analyst]

This is Clay calling in for Paul. Congratulations on the NDA acceptance I guess with regard to the updated commercial plan for UGN-102, could you perhaps provide an overview of how like the whole process could be improved and incrementally perhaps just in the context of the challenges some of the urologists face with JELMYTO, whether that's access reimbursement, the process of actually administering the drug itself, et cetera, that would be really helpful to get like a 30,000-foot view.

[Elizabeth Barrett, executive]

Absolutely. David?

[David Lin, executive]

Yes. Thanks for the question. So I think a couple of things. When we draw on, we take what we've learned from JELMYTO, and we also think about the unique nature of treating patients with low-grade intermediate risk non-muscle invasive bladder cancer. So a couple of things. What we learned about JELMYTO is that the operational financial support has to immediately follow the clinical discussion. So once we've identified that there's clinical conviction around identifying patients and treating with JELMYTO, we immediately follow up with helping them to operationalize the actual six doses and then make sure that they have the education and support from a reimbursement perspective.

All of that will still hold true with a potential UGN-102 approval. What's important also is -- what's different with UGN-102, I'll say, is that because it is a process that is much more familiar to the physician offices, we will still do the requisite training from a clinical perspective. But one of the things we will also do is right upfront, help them understand how this fits into their workflow. And how they identify the low-grade intermediate risk non-muscle invasive bladder cancer patient. So all of that together, as we will leverage everything we learned about JELMYTO. We'll pivot accordingly to the new patient population. But all of that just means that we will continue to drive clinical conviction upon approval. And also support them operationally and financially.

And it is worth reminding that ahead of PDUFA, our medical affairs team continues to educate the urology community on the ENVISION data and the unmet need in low-grade intermediate risk non-muscle invasive bladder cancer.

[Elizabeth Barrett, executive]

And just to add a couple of things to that. One, remember the rare disease nature of JELMYTO versus the not so rare disease nature versus of UGN-102. So all physicians, I mentioned earlier see these patients. And you don't need special equipment. It gets done by a nurse in the office, to your point about the ease of use. And we have learned that JELMYTO is hard. The physicians will say, it's a heavy lift for the practice and a heavy lift. And so the bar was definitely very different. And even though we've done, I think, a really good job of supporting as best we can. At the end of the day, it is what it is, right? You either have to have a fluoroscopy, manipulate the upper track or you've got to have a nephrostomy tube. And so I think when you look at UGN-102 and the ease of use around that, and we've heard that from -- we got the feedback from all the positions we've spoken to and the practices that we've spoken to, it's going to be a very, very different situation. But thanks for the question. .

[Operator]

Thank you. I am showing no further questions at this time. I would now like to turn it back to Liz Barrett for closing remarks.

[Elizabeth Barrett, executive]

Okay. Thank you. We continue to make progress across the company with our priorities and really do believe that we are a uniquely positioned company to change the practice for bladder cancer in these patients and also to bring significant value to our shareholders. So as always, we appreciate your support, and we'll keep you posted on things as they arise. So appreciate it. Thank you.

[Operator]

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.