Q3 2024 UroGen Pharma Ltd Earnings Call
Good morning, ladies and gentlemen. Thank you for standing by and welcome to the hero gen Barrett, third quarter, 2020 for 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.
Speaker Change: Thank you, operator. Good morning, everyone. And welcome to your agenda, Farmers 3rd Quarter 2024 by the Interest Office 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-end incident of 10th or 30, 2024.
The press release can be accessed on the Investors portion of our website at investors.urigen.com
Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, David Lynn, Chief Commercial Officer, and Chris Begdon, Chief Financial Officer.
During today's call, we will be making certain photo-looking statements.
These main crew statements regarding our ongoing commercialization activities related to gel mine out.
Our ongoing plan clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations as well as future commercialization activities for UGN102 at approved.
and to support his data, regulatory filings and decisions, UGN102 being the growth driver for your again, at Pro Pro. Future R&D efforts are corporate goals in 2024 financial guidance among others.
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 your agenda displays any obligation to update these statements.
I'll now turn the call over to Liz Barrett.
Liz Barrett: 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 UGM-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.
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, UGM-102 will become the first FDA-approved medicine for this patient population, introducing a novel solution that can significantly reduce recurrent rates while extending the time between treatments.
UGM 102 aligns with our commitment to enhancing patient outcomes and reshaping treatment paradigms in neurologic oncology.
The market opportunity for UGM 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 10 times larger than the market Yalmito currently serves.
Liz Barrett: and represents an estimated total addressable market of over $5 billion.
In contrast to the gel mito market opportunity in low-grade upper tracheal filial carcinoma, which is a rare disease which is dispersed and episodic, low-grade intermediate risk anomalous invasive bladder cancer is widespread and regularly managed by nearly all urologists.
Liz Barrett: UGN 102 is straightforward to administer and integrates seamlessly into existing outpatient practice workflows without the need for special equipment.
Delmito 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 Act sales.
in Q3 of 2024 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 percent versus a year ago.
Speaker Change: Thank you.
Liz Barrett: Looking ahead at the core of URGEN's lifecycle management strategy is ensuring the long-term success and growth of our uro-oncology franchise.
Liz Barrett: 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 gelmito, respectively.
Liz Barrett: Upon issuance, the patent will extend through December of 2041 and cover the innovative combination of our proprietary RT gel technology with a unique mitomycin formulation licensed from Medac.
Liz Barrett: Dosing in the Phase III Utopia trial for UGM-103 commenced in early October demonstrated continued momentum in our clinical development. Mark will provide further details on this exciting progress.
Liz Barrett: In October, we appointed Chris Dagnon as Chief Financial Officer.
Liz Barrett: Chris has extensive CFO experience with publicly traded biotech companies.
Liz Barrett: most recently at Galera Therapeutics and Verica Pharmaceuticals.
Liz Barrett: He has also held senior positions at Indow International and worked at AstraZeneca for more than 10 years. He has broad expertise in financial strategy, investor relations, SEC reporting, accounting, and compliance.
Speaker Change: I want to take this opportunity to formally welcome Mr. Krierijan. He is joining us on the call today and will provide financial results for the quarter shortly.
Liz Barrett: Chris's 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.
Mr. Krierijan: 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 throughout the review process.
Liz Barrett: 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.
Liz Barrett: The Phase III Envisioned Trial, which serves as the pivotal trial for the NDA, successfully met its primary endpoint, demonstrating a 79.6% complete response rate at three months after the first installation of UGN-102.
Liz Barrett: 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 at three months. Notably, this represents the highest duration of response ever reported in this patient population.
Liz Barrett: 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.
Liz Barrett: 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.
Liz Barrett: If approved, we believe UGN-102 will represent a significant advancement in the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer.
Speaker Change: Turning now to the pipeline, as Liz mentioned.
Speaker Change: We have a comprehensive life cycle management plan for gelmito and UGN-102.
Speaker Change: In October, we announced the dosing of the first patient in the Phase III clinical trial evaluating UGN-103 for the treatment of low-grade, intermediate-risk, non-muscle basal bladder cancer.
Speaker Change: The UTOPIA trial is a single arm, phase 3, multi-center study designed to evaluate the efficacy and safety of UGN-103. Our goal is to enroll 87 patients.
Speaker Change: efficacy will be assessed based on the complete response rate at the three month mark.
Speaker Change: Patients achieving 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 three months for ongoing evaluation of duration of response.
Speaker Change: We anticipate filing the new drug application with the FDA in 2026.
Speaker Change: and if approved at the commercial launch in 2027. We foresee a similar development plan for UGN-104, our next generation formulation of gelmido and expect to commence a single arm phase three study early next year.
Speaker Change: Turning to our high-grade bladder cancer pipeline, we continue to develop our immuno-oncology candidate, UGM-301.
Liz Barrett: UGN-301 is an anti-CTLA-4 antibody delivered using our proprietary RT-gel technology. We are conducting a Phase I clinical study to evaluate safety, tolerability, and to establish a recommended Phase II dose for UGN-301.
Liz Barrett: We will present an update of our UGM 301 program at the upcoming Society of Urologic Oncology meeting.
Liz Barrett: scheduled for December 4th through 6th in Dallas.
Liz Barrett: Additional abstracts were accepted for poster presentation, including the envisioned duration of response data and long-term follow-up results from the Gelmido Olympus trial. This year's meeting promises to be particularly productive for our team.
Speaker Change: And now over to David Lin for a commercial update. David?
David Lin: Thank you, Mark. Good morning, everyone. As we focus on the journey ahead with UGN 102, my top priority continues to be preparing Urigen for an anticipated commercial launch in 2025.
Liz Barrett: With the target PDUFA date of June 13, 2025 now established, we have a clear timeline for potential approval and launch.
Liz Barrett: 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.
Liz Barrett: 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.
Liz Barrett: The launch of UGN 102 would mark Urigen's evolution from a rare disease focused organization to a specialty focused multi-product team.
Liz Barrett: A significant factor in our decision to expand our sales force stems from our learnings and experiences with gelmido. We have learned that more engagement from our sales and support teams leads to more effective responses from clinical practices.
Liz Barrett: To that end, we are committed to having an appropriately sized field force in place by the launch of UGN-102.
Liz Barrett: Our updated launch plan is designed to significantly increase the frequency of interactions with targeted physicians, ensuring we maximize our impact in the market.
Liz Barrett: At the same time, we are actively advancing our pre-launch activities for UGM 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.
Liz Barrett: While our medical affairs team is also sharing our clinical data to appropriately communicate the value proposition ahead of approval.
Liz Barrett: To facilitate the integration of UGN 102 into treatment protocols, we will provide comprehensive support, including training for healthcare professionals and their office staff.
Liz Barrett: Additionally, we are implementing engagement initiatives to inform both clinical practices and patients about UGN 102's coverage options and reimbursement.
Liz Barrett: 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.
Liz Barrett: Based on the June 2025 PDUFA date, we would expect to secure a unique permanent J code for UGN 102 by January 2026.
Liz Barrett: 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.
Liz Barrett: 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.
Speaker Change: I will now turn the call over to Chris Degnan to discuss our financials.
Chris Degnan: Thank you, David, and good morning, everyone.
Chris Degnan: Before I get into the financials, I would first like to take a moment to say that I'm thrilled to join Urgent at such a pivotal time for the company.
Liz Barrett: The strength of our pipeline and the significant market opportunities ahead present a unique moment for growth and innovation.
Liz Barrett: 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.
Liz Barrett: Turning now to the quarter, as Liz mentioned, Jomito 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.
Liz Barrett: Our focus efforts to increase our reach and frequency with key accounts generated solid momentum, which positively impacted Q3 results.
Liz Barrett: Volume growth was partially offset by continued year-over-year growth to net erosion due in part to the Medicare wastage provision and growing 340B utilization.
Liz Barrett: The overall gross net rate for gelmido was relatively consistent quarter over quarter.
Liz Barrett: Cost of revenue in the third quarter was $2.5 million compared with $2.4 million for the comparable period in 2023.
Liz Barrett: This slight increase was primarily attributable to the increased volume of sales of Jomito, partially offset by certain non-recurring payments made in connection with our supply arrangement in the prior year.
Liz Barrett: Research and development expenses in the third quarter were $11.4 million, compared with $10.2 million for the comparable quarter in 2023.
Liz Barrett: The increase, year over year, was primarily attributable to higher costs related to the initiation of the Phase III Utopia trial for UGN-103, partially offset by lower UGN-102 clinical trial costs.
Liz Barrett: and costs related to the research into ingredients, scale-up, and production efficiency for gelmido.
Liz Barrett: Selling, general, and administrative expenses for the third quarter of 2024 were $28.9 million, including non-cash, share-based compensation expense of $2.9 million.
Liz Barrett: This compares to $21.8 million, including non-cash, share-based compensation expense of $1.8 million for the same period in 2023.
Liz Barrett: The year-over-year increase was primarily driven by UGN 102 pre-commercialization activities.
Liz Barrett: We reported non-cash financing expense of $5.9 million in the third quarter relating to the prepaid forward obligation to RTW Investments.
Liz Barrett: This compares with $5.5 million in the comparable period in 2023.
Liz Barrett: The increase of $0.4 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate.
Liz Barrett: Interest expense related to the 125 million dollar term loan facility with Pharmacon Advisors was 2.7 million dollars in the third quarter compared with 3.8 million dollars for the comparable period in 2023.
Liz Barrett: The decrease was primarily attributable to the decrease in the margin interest rate and the related impact to amortization of the discount on the Pharmacon loan as a result of the amended and restated loan agreement in March 2024.
Liz Barrett: The third tranche of $25 million under the amended and restated loan agreement was funded in late September 2024.
Liz Barrett: 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.
Liz Barrett: As of September 30, 2024, we had $254.2 million in cash and cash equivalents and marketable securities.
Liz Barrett: With our fortified balance sheet, we believe we have the requisite cash and capital to execute our business objectives.
Liz Barrett: Turning to Ford Guidance.
Liz Barrett: Although we saw strong underlying demand in the quarter, we expect full-year Gelmido revenues to fall below the low end of our previous guidance.
Liz Barrett: However, we do believe that Gelmido will deliver low double-digit revenue growth for the full year despite the higher-than-expected gross-to-net headwinds in recent quarters.
Liz Barrett: and David Tse. Thank you. Thank you. Thank you. Thank you.
Liz Barrett: Regarding 2024 full-year operating expense guidance, we now expect operating expenses to be near the midpoint of our previously guided range of $175 to $185 million, including non-cash share-based compensation expense of $9 to $13 million.
Liz Barrett: 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.
Liz Barrett: The anticipated full year 2024 non-cash financing expense related to the prepaid obligation to RTW Investments is unchanged and expected to be in the range of $21 to $26 million.
Liz Barrett: The rate for the cash component of the RTW obligation will be 13% of global net product sales of gelmido in 2024.
Liz Barrett: We are now ready to open the call for questions. Operator?
Speaker Change: Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw a question, please press star 1-1 again. Please stand by while we compile the Q&A roster.
Liz Barrett: Our first question comes from the line of Tara Bancroft with TD Cohen. Your line is now open.
Tara Bancroft: Hi, and good morning. 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, you know, aside from the letter.
Liz Barrett: if you have any other insight into that based on your interactions. Thanks.
Liz Barrett: Thanks, Terrence, 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 to demonstrate efficacy?
Liz Barrett: what's the role of Atlas, and overall, is the AE profile acceptable? So kind of the typical, what you expect the FDA to say at this point in time.
Liz Barrett: We do know 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 non-clinical, but they had not yet reviewed the clinical portion.
Liz Barrett: Look, we can sit here and guess as to why, you know, my view on it is obviously the Pryder review would have put them against the wall from a timing standpoint.
Liz Barrett: And, you know, 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.
Liz Barrett: 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.
Liz Barrett: 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, you know, guess we have, but nothing...
Liz Barrett: They didn't even acknowledge, one way or the other, the priority versus standard review. Just gave us our timing and then gave us the, here are your potential review issues, and the three that I mentioned.
Speaker Change: Thank you.
Speaker Change: Okay, great. Yeah, that makes a lot of sense. Thanks so much.
Speaker Change: Thanks Tara.
Speaker Change: Thank you. Our next question comes from the line of Ram Selvaraju with HC Wainwright & Co. Your line is now open.
Ram Selvaraju: Thanks very much for taking my questions. Firstly, I was wondering if you could elaborate on a couple of commercial points, particularly the growth to net discounting with respect to gelmido and why you expect that not to be a factor for UGN 102.
Ram Selvaraju: you know, the yield loss.
Speaker Change: that we see with the mixing of gelmito and 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 gelmito.
Speaker Change: Thank you. Thank you.
Speaker Change: And then with respect to the commercial preparations for UGN-102, can you maybe give us a sense of how the timeline might have shifted with respect to the receipt of standard review for the 102 NDA application, and when you expect to incept specific pre-launch activities as you approach the PDUFA date?
Speaker Change: Thank you.
Speaker Change: Hi, this is David.
Liz Barrett: Standard review doesn't change consequentially any of the major things we're doing in terms of pre-launch 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
Liz Barrett: Low-Grade Intermediate
Liz Barrett: bladder cancer.
Liz Barrett: 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 great.
Liz Barrett: preparing our infrastructure and our distribution.
Speaker Change: That works
Liz Barrett: 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.
Speaker Change: 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. Thanks.
Mark Schoenberg: I think the short answer is, while I don't know the composition, my suspicion would be
Mark Schoenberg: that it would be reflective of other ADCOMs, particularly reflected by, you know, the...
Liz Barrett: evaluation of other drugs in this space, so we'd expect some urologists.
Liz Barrett: particularly urologic oncologists would expect, would experience.
Liz Barrett: 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 neurologic oncologists who have familiarity with non-muscle nasobladder cancer.
Speaker Change: Unfortunately, Ram, I don't have an answer to your question around the IP, but I'll find out from the GC and let you know.
Speaker Change: Thank you very much and congrats to all the progress, particularly the MBA acceptance. Very important for the company. Great. Thank you, Ram. Appreciate it.
Speaker Change: Thank you.
Speaker Change: Thank you. One moment for our next question.
Speaker Change: Our next question comes from the line of Leland Gershel with Oppenheimer. Your line is now open.
Leland Gershel: Thanks for the commentary and taking my questions. So I just wanted to fill in further on the...
Leland Gershel: on the IP with respect to the type of litigation. I'm wondering if you can give us any timelines with respect to next steps in the Markman hearing.
Liz Barrett: being scheduled or hasn't been scheduled due to any disability and when that may occur.
Speaker Change: Yeah 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.
Liz Barrett: But, you know, we don't have that information yet. So, you know, to be honest with you, we're sort of just moving forward with all of the
Liz Barrett: Dr Ivanka Trujillo
Liz Barrett: and making sure that we're fully prepared for that outcome.
Liz Barrett: Okay, and we're good.
Leland: Would the implications be, you know, for whatever the outcome is with the Jelmido litigation, you know, would those carry over to presumably UGN-102, given overlapping IP? In other words, if you were to prevail, then presumably that would hinder the ability for generic to…
Leland: 102. Is that a fair concession?
Speaker Change: Yes, that's a fair conclusion on that, and the reality of it is that until we get an approval, they can't do anything. But yes, we fully expect that to happen.
Leland: A little difference with 102, we do have some other pending patents for UGN-102.
Leland: that we think will even make that stronger than where we are to, you know, just put other things around it. And just keep in mind and remember that for both of them,
Leland: the next generation formulation for UGN-102 which is UGN-103 will actually
Liz Barrett: expect approval in 27. So we that would actually be on the market before you ever even got regulatory.
Leland: 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.
Speaker Change: Okay, thanks for taking the questions.
Speaker Change: Thanks Leland.
Leland: Thank you.
Speaker Change: Our next question comes from the line of Kelsey Goodwin with Guggenheim. Your line is now open.
Leland: and many more. Thank you.
Kelsey Goodwin: Oh, hey, everyone. Thanks for taking our questions and congrats on all the progress the last few months.
Kelsey Goodwin: 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?
Kelsey Goodwin: 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? Thank you.
Speaker Change: Yeah, great and nice to talk to you, Kelsey. We, you know, from, you know, from the standpoint of your last question on
Kelsey Goodwin: on the Miscellaneous Code. I'll ask David to sort of comment on that. But so, David, you want to take that first? Yeah. Hi, Kelsey. Our expectation in terms of that initial period is not unlike a lot of the other...
David: 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.
David: in terms of training and operations of how to manage the billing during that cycle and there's plenty of examples that we can draw on from not only Gelmido but also other products that have launched in the space.
Speaker Change: Yeah, and I think, you know, in addition to that, I think what you would expect is in the beginning, the sites of care, very much like Jelmido as well, were more in the hospital than they were in the community setting for that exact reason.
Speaker Change: 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 an ODAC.
Kelsey Goodwin: We expect to know that. The agency has been very clear on that from the beginning. You know, 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.
Kelsey Goodwin: The timing on it, usually you see the ODAC two to three months prior to the PDUFA, so we would expect the ODAC, you know, in the April time frame. It could go as late as May, and we expect a two to three month notice.
Kelsey Goodwin: So, if it's May, then we expect to find out by the beginning of March, if it's April, you know, maybe the February, you know, beginning of, again, beginning of March, depending on when in April. So, April, May timing for the actual ODAC.
Kelsey Goodwin: There is the other...
Kelsey Goodwin: The next step is our mid-cycle review meeting. We actually do have a meeting with them, and that would be in the January-February timeframe. We will ask at that meeting for an update on the ODAC and expect that we at least will get some acknowledgment.
Kelsey Goodwin: and, you know, idea of timing. But, you know, just to know we're in full ODAC preparation. We've actually always been welcomed in ODAC. I know that that sounds, you know, odd, but given
Kelsey Goodwin: What we know about users and physicians and practitioners and the way that they think about this.
Kelsey Goodwin: You know, we believe that that would actually be helpful for us. And so, you know, we're, you know, 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.
Kelsey Goodwin: The patients that will be talking at ODAC on our behalf and believe that physicians and clinicians will actually welcome the opportunity to have a medicine like UGM-102.
Speaker Change: Great. Thank you so much.
Kelsey Goodwin: Thanks.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of Matt Kaplan with Leidenberg Thalmann. Your line is now open.
Kelsey Goodwin: and many more. Thank you. Thank you.
Speaker Change: Hey guys, thanks for taking the question.
Kelsey Goodwin: Just wanted to follow up on the ODAC.
Kelsey Goodwin: Thank you.
Kelsey Goodwin: I guess, you know, frequently ODACs are called if there's some controversy.
Kelsey Goodwin: Can you talk a little bit about the...
Kelsey Goodwin: buy-in that you have from the FDA on the envisioned trial design as a single arm study and how it could suffice for the approval of 102 and does that also, is there any controversy there with respect to also I guess Utopia's phase three design as very similar design to the FDA?
Kelsey Goodwin: to the EnVision study as well.
Mark Schoenberg: Hey 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 InVision
Mark Schoenberg: could potentially support approval of EGN-102, which was, in fact,
Kelsey Goodwin: 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.
Kelsey Goodwin: With respect to your sort of larger question about what are the controversies or what might be underlying the need for an ODAC
Kelsey Goodwin: non-muscle basal bladder cancer.
Kelsey Goodwin: 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 UGM-102 and its inclusion in the armamentarium currently available to urologists for the treatment of this population of patients.
Speaker Change: Okay. Thanks, Mark. That's very helpful. And then just a question for...
Speaker Change: For Chris, with respect to your 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.
Chris Degnan: Thanks for the question. So we exited with a fortified balance sheet, $254 million in cash. And we believe that we have the requisite cash to get the business to profitability based off of our current business objectives, based off of the June PDUFA date.
Speaker Change: Thank you.
Chris Degnan: Great. Thanks for taking the question, guys. Thanks, Matt.
Speaker Change: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.
Speaker Change: Hi everyone, this is Khalil calling in for Paul. Thank you so much for taking our questions and 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 the whole process could be improved incrementally perhaps? Just in the context of the challenges some of the urologists face with gelmido, whether that's...
Speaker Change: Access, Reimbursement, the process of actually administering the drug itself, etc. That'd be really helpful if you get like a 30,000 foot view. Thank you so much. Sure. Absolutely.
Speaker Change: Yeah, thanks for the question. So I think a couple of things when we draw on we take what we've learned from gelmito 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 gelmito is
Speaker Change: that the operational financial support has to immediately follow
Speaker Change: the clinical discussion. So once we've identified
Speaker Change: that there's clinical conviction around identifying patients and treating with
Speaker Change: John Maido
Speaker Change: 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.
Speaker Change: All of that will still hold true with a potential UGN-102 approval.
Speaker Change: What's important also is what's different with UGM-102, I'll say.
Speaker Change: is that because it is a process that is much more familiar to the physician offices.
Speaker Change: We will still do the requisite training.
Speaker Change: from a clinical perspective, but one of the things we will also do
Speaker Change: is right up front, help them understand how this fits into their workflow and how they identify the low-grade, intermediate-risk, non-muscle-invasive bladder cancer patient.
Speaker Change: So, all of that together is we will leverage everything we learned with Jelmido, 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.
Speaker Change: And it is worth reminding that a head 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.
Speaker Change: And just to add a couple of things to that, one, remember the rare disease nature of Jelmido versus the not-so-rare disease nature versus of Eugene-102, so all physicians I mentioned earlier see these patients.
Speaker Change: And you don't need special equipment. It gets done by a nurse in the office, to your point about the ease of use.
Speaker Change: And we have learned that, you know, gelmido is hard, you know, the physicians will say it's a heavy lift for the practice and a heavy lift.
Speaker Change: 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, you know, manipulate the upper tract, or you've got to have a nephrostomy tube.
Speaker Change: And so I think when you look at UGM 102 and the ease of use around that, and we've heard that from, gotten feedback from all the physicians we've spoken to, and the practices that we've spoken to, it's going to be a very, very different situation.
Speaker Change: But thanks for the question.
Speaker Change: Thank you. Thank you.
Speaker Change: Thank you.
Speaker Change: and many more. Thank you. Thank you.
Speaker Change: 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.
Liz Barrett: 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.
Speaker Change: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
Speaker Change: Thank you. Thank you.
Speaker Change: Special Thanks to Jeffrey Bova and Don Kim Transcription by Trans-Experts Online And thanks to
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