UroGen Pharma Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
November 6, 2024

There are 12 speakers on the call.

Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the EuroGen 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 Perron, Head of Investor Relations. You may now begin.

Speaker 1

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's Q3 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.

Speaker 1

Joining me on the call today are Liz Barrett, President and Chief Executive Officer Doctor. Mark Schoenberg, Chief Medical Officer David Lin, Chief Commercial Officer and Chris Stegman, 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 GelMiner, 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-one hundred and two if approved, anticipated data, regulatory filings and decisions, UGN-one hundred and two being the growth driver for UroGen, if approved, future R and 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.

Speaker 1

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 EuroGen disclaims any obligation to update these statements. I'll now turn the call over to Liz Barron.

Speaker 2

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-one hundred and two, 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-one hundred and two 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.

Speaker 2

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-one hundred and two to patients at the earliest opportunity. David will provide more details on this shortly. If approved, UGN-one hundred and two will become the 1st FDA approved medicine for this patient population, introducing a novel solution that could significantly reduce recurrent rates, while extending the time between treatments.

Speaker 2

UGN-one hundred and two aligns with our commitment to enhancing patient outcomes and reshaping treatment paradigms in urologic oncology. The market opportunity for UGM-one hundred and two 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 JALMIDO currently serves and represents an estimated total addressable market of over $5,000,000,000 In contrast to the JALMIDO market opportunity and low grade upper upper trachealothelial carcinoma, which is a rare disease, which is dispersed and episodic, low grade intermediate risk on most invasive bladder cancer is widespread and regularly managed by nearly all urologists. UGN-one hundred and two is straightforward to administer and integrate seamlessly into existing outpatient practice workflows without the need for special equipment.

Speaker 2

Jomita delivered 25 point $2,000,000 in net product revenue for the 3rd quarter, representing a 21% year over year increase. The revenue reflected strong underlying patient demand, but also included $2,600,000 from Create AXLs in Q3 of 2024 compared to $1,100,000 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 Q3 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 year ago.

Speaker 2

We are seeing signs of continued momentum in early Q4 and expect to be able to deliver low double digit revenue growth for JALMAYDO for the full year 2024, despite the gross to net headwinds we experienced in recent quarters. Looking ahead, at the core of UroGen's lifecycle 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-one hundred and three and UGN-one hundred and four, our next generation therapies for UGN-one hundred and two and gel Mito respectively.

Speaker 2

Upon issuance, the patent will extend through December of 2041 and cover the innovative combination of our proprietary RTGel technology with a unique mitomycin formulation licensed from MEDDAC. 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 UGM-one hundred and three 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.

Speaker 2

Chris has extensive CFO experience with publicly traded biotech companies, most recently at Galera Therapeutics and Verica Pharmaceuticals. He has also held senior positions at Endo International and worked at AstraZeneca for more than 10 years. He has broad expertise in financial strategy, Investor Relations, SEC reporting, accounting and compliance. I want to take this opportunity to formally welcome to Craig Urogyen. He is joining us on the call today and will provide financial results for the quarter shortly.

Speaker 2

Chris' appointment is part of the broader initiative to enhance our leadership team as we prepare to commercialize UGN-one hundred and two 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 Schomburg, our Chief Medical Officer for a clinical update. Mark?

Speaker 3

Thank you, Liz. I want to begin by echoing Liz's sentiments regarding the FDA's acceptance of our NDA for UGN-one hundred and two. 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-one hundred and two 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 3 late phase clinical trials, along with an acceptable safety profile.

Speaker 3

The Phase 3 ENVISION trial, which serves as the pivotal trial for the NDA, successfully met its primary endpoint demonstrating a 79 0.6% complete response rate at 3 months after the first installation of UGN-one hundred and two. 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 3 months. Notably, this represents the highest duration of response ever 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.

Speaker 3

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-one hundred and two will represent a significant advancement in the treatment of low grade intermediate risk non muscle and basal bladder cancer. Turning now to the pipeline, as Liz mentioned, we have a comprehensive life cycle management plan for gel Mito and UGN-one hundred and two. In October, we announced the dosing of the first patient in the Phase III clinical trial evaluating UGN-one hundred and three for the treatment of low grade intermediate risk non muscle invasive bladder cancer.

Speaker 3

The Utopia trial is a single arm Phase 3 multicenter study designed to evaluate the efficacy and safety of UGN-one hundred and three. 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-one hundred and three via intravascular installation once a week for 6 weeks. Efficacy will be assessed based on the complete response rate at the 3 month mark. 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 3 months for ongoing evaluation of duration of response.

Speaker 3

We anticipate filing the new drug application with the FDA in 2026 and if approved, the commercial launch in 2027. We foresee 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 3 study early next year. Turning to our high grade bladder cancer pipeline, we continue to develop our immuno oncology candidate UGN-three zero one. UGN-three zero one is an anti CTLA-four antibody delivered using our proprietary RTGel technology. We are conducting a Phase 1 clinical study to evaluate safety, tolerability and to establish a recommended Phase 2 dose for UGN-three zero one.

Speaker 3

We will present an update of our UGN-three zero one program at the upcoming Society of Urologic Oncology meeting scheduled for December 4 through 6 in Dallas. Additional abstracts were accepted for poster presentation, including the ENVISION duration of response data and long term follow-up results from the JEL MITO 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?

Speaker 4

Thank you, Mark. Good morning, everyone. As we focus on the journey ahead with UGN-one hundred and two, my top priority continues to be preparing UroGen for an anticipated commercial launch in 2025. With the target PDUFA date of June 13, 2025 now established, we have a clear timeline for potential approval and launch. Our immediate priority is executing a robust pre commercial strategy that will establish a solid foundation for making UGN-one hundred and two accessible to the medical community and driving widespread adoption.

Speaker 4

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-one hundred and two would mark UroGen's evolution from a rare disease focused organization to a specialty focused multi product 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 our learnings and experiences with Gelmido.

Speaker 4

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-one hundred and two. 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 pre launch activities for UGN-one hundred and two. 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.

Speaker 4

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-one hundred and two into treatment protocols, we will provide comprehensive support, including training for healthcare professionals and their office staff. Additionally, we are implementing engagement initiatives to inform both clinical practices and patients about UGN-one hundred and two's coverage options and reimbursement. It's important to note that upon approval, UGN-one hundred and two 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-one hundred and two by January 2026.

Speaker 4

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-one hundred and two is seamless. I will now turn the call over to Chris Deignan to discuss our financials.

Speaker 5

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 present 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.

Speaker 5

As Liz mentioned, Jomito net product revenues reached $25,200,000 in the Q3 of 2024 compared to $20,900,000 for the same period in 2023, primarily driven by strong underlying demand growth. Our focus 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 waste is provision and growing 340B utilization. The overall gross to net rate for Gelmido was relatively consistent quarter over quarter. Cost of revenue in the Q3 was $2,500,000 compared with $2,400,000 for the comparable period in 2023.

Speaker 5

The slight increase was primarily attributable to the increased volume of sales of gel Maito, partially offset by certain non recurring payments made in connection with our supply arrangement in the prior year. Research and development expenses in the Q3 were $11,400,000 compared with $10,200,000 for the comparable quarter in 2023. The increase year over year was primarily attributable to higher costs related to the initiation of the Phase 3 Utopia trial for UGN-one hundred and three, partially offset by lower UGN-one hundred and two clinical trial costs and costs related to the research into ingredient scale up and production efficiency for JALMIDO. Selling, general and administrative expenses for the Q3 of 2024 were $28,900,000 including non cash share based compensation expense of $2,900,000 This compares to $21,800,000 including non cash share based compensation expense of $1,800,000 for the same period in 2023. The year over year increase was primarily driven by UGN-one hundred and two pre commercialization activities.

Speaker 5

We reported non cash financing expense of $5,900,000 in the 3rd quarter relating to the prepaid forward obligation to RTW Investments. This compares with $5,500,000 in the comparable period in 2023. The increase of $400,000 was driven primarily by changes in underlying assumptions for remeasuring the effective rate. Interest expense related to the $125,000,000 term loan facility with PharmaCon Advisors was $2,700,000 in the 3rd quarter compared with $3,800,000 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.

Speaker 5

The 3rd tranche of $25,000,000 under the amended and restated loan agreement was funded in late September 2024. Net loss for the Q3 was $23,700,000 or $0.55 per basic and diluted ordinary share as compared to a net loss of $21,900,000 or $0.68 per basic and diluted share in the same period in 2023. As of September 30, 2024, we had $254,200,000 in cash and cash equivalents and marketable securities. With our fortified balance sheet, we believe we have the requisite cash and capital to execute our business objectives. Turning to forward guidance.

Speaker 5

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. 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 $175,000,000 to $185,000,000 including non cash share based compensation expense of $9,000,000 to $13,000,000 This outlook reflects the shift in timing of expenditures tied to the PDUFA target date and preparations for the potential commercial launch of UGN-one hundred and two. 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 $21,000,000 to $26,000,000 The rate for the cash component of the RTW obligation will be 13% of global net product sales of Gelmido in 2024. We're now ready to open the call for questions.

Speaker 5

Operator?

Operator

Thank you. Our first question comes from the line of Tara Bancroft with TD Cowen. Your line is now open.

Speaker 6

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 aside from the letter, do you have any other insight into that based on your interactions?

Speaker 6

Thanks.

Speaker 2

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 the AE profile acceptable.

Speaker 2

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 non clinical, 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 to review would have put them against the wall from a timing standpoint. And the argument has always been, well, they can go back to surgery.

Speaker 2

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.

Speaker 2

Just gave us our timing and then gave us the here are your potential review issues and with the 3 that I mentioned.

Speaker 6

Okay, great. Yes, that makes a lot

Speaker 2

of sense. Thanks so much. Thanks, Tara.

Operator

Thank you. Our next question comes from the line of Ram Selvaraju with H. C. Wainwright and Co. Your line is now open.

Speaker 7

Thanks very much for taking my questions. Firstly, I was wondering if you could elaborate on a couple of commercial points, particularly the gross to net discounting with respect to JALMIDO and why you expect that not to be a factor for UGN-one hundred and two?

Speaker 2

Sure. Chris, do you want to take that?

Speaker 5

Sure. Ram, so the 2 big headwinds we've been seeing on gross to net, one is 340B and the second is the Medicare Wases provision. With respect to 102, we don't expect the Wases provision to apply just given the yield loss that we see with the mixing of Jelmito 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 gel Mito.

Speaker 7

And then with respect to the commercial preparations for UGN-one hundred and two, 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 4

David? Yes. Hi, this is David. The standard review doesn't change consequentially any 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 low grade intermediate bladder cancer.

Speaker 4

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-one hundred and two.

Speaker 7

Okay. And then just 2 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. Thank you.

Speaker 2

Why don't you go ahead Mark and then?

Speaker 3

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.

Speaker 3

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.

Speaker 2

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

Speaker 7

Thank you very much and congrats on all the progress, particularly the NDA acceptance, very important for the company.

Speaker 2

Great. Thank you, Ram. Appreciate it.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Leland Gershell with Oppenheimer. Your line is now open.

Speaker 8

Thanks for the commentary and taking my questions. So just wanted to fill in further on the IP with respect to the type of litigation. Wondering if you can give us any timelines with respect to next steps. Is the Markman hearing being scheduled or hasn't been scheduled? Do you have any visibility on when that may occur?

Speaker 2

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.

Speaker 2

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, 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 the for that outcome.

Speaker 8

Okay. And would the implications be for whatever the outcome is with the JALMIDO litigation, would those carry over to presumably UGN-one hundred and two given overlapping IP? In other words, if you were to prevail, then presumably that would hinder the ability for generic to 102. Is that a fair concern?

Speaker 2

Yes, that's a fair conclusion on that. And reality of it is, is that 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-one hundred and two that we think will even make that stronger than where we are to just put further things around it. And just keep in mind and remember that for both of them, the next generation formulation for UGN-one hundred and two, which is UGN-one hundred and three, we'll actually expect approval in 20 20 7.

Speaker 2

So we that would actually be on the market before you ever even got regulatory exclusivity was up for UGM-one hundred and two. 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.

Speaker 8

Okay. Thanks for taking the questions.

Speaker 2

Yes. Thanks, Leland.

Operator

Thank you. Our next question comes from the line of Kelsey Goodwin with Guggenheim. Your line is now open.

Speaker 9

Hey, everyone. Thanks for taking our questions and congrats on all the progress 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-one hundred and two uptake in the initial quarters with the miscellaneous J code versus the permanent J code likely in 2026?

Speaker 9

Thank you.

Speaker 2

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, you want to take that first?

Speaker 4

Yes. Hi, 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 the billing during that cycle. And there's plenty of examples that we can draw on from not only GelMida, but also other products that have launched in the space.

Speaker 2

Yes. And I think, in addition to that, I think what you would expect is in the beginning, the sites of care, very much like JALMIDO 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 a ODAC. We are in full preparation for ODAC. We expect a ODAC.

Speaker 2

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 timeframe.

Speaker 2

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's April, maybe the February beginning of again 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.

Speaker 2

We actually do have a meeting with them and that would be in kind of January, February timeframe. And we will ask at that meeting for an update on the ODAC and expect that we at least we'll get some acknowledgment and idea of timing. But just to know we're in full ODAC preparation. We've 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 that would actually be helpful for us.

Speaker 2

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 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-one hundred and two.

Speaker 9

Great. Thank you so much. Thanks. Thank you.

Operator

Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Your line is now open.

Speaker 10

Hey, guys. Thanks for taking the question. And just wanted to follow-up on the ODAC. I guess frequently ODACs 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 for the approval of 102?

Speaker 10

And does that also is there any controversy there with respect to also I guess Utopia's Phase 3 design as very similar design to the ENVISION study as well?

Speaker 3

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 Envision could potentially support approval of EGN-one hundred and two, 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.

Speaker 3

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 very clear about the idea that UGN-one hundred and two present urologists and patients with a potentially paradigm changing approach to non muscle mesa 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 VGN-one hundred and two and its inclusion in the armamentarium currently available to urologists for the treatment of this population of patients.

Speaker 10

Okay. Thanks, Mark. That's very helpful. And then just a question for Chris. With respect to your cash runway, how should we think about that?

Speaker 10

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?

Speaker 5

Yes, Matt. Thanks for the question. So we exited with a 4 to 5 balance sheet, dollars 254,000,000 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 10

Great. Thanks for taking the question guys.

Speaker 2

Thanks, Matt.

Speaker 3

Thanks, Matt.

Speaker 9

Thank you.

Operator

Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.

Speaker 11

Hi, everyone. This is Cleo 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-one hundred and two, 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 faced with JALMIDO, whether that's access reimbursement, the process of actually administering the drug itself, etcetera, that'd be really helpful to get like a 30,000 foot view? Thank you so much.

Speaker 2

Sure. Absolutely. David?

Speaker 4

Yes. Thanks for the question. So I think a couple of things. When we draw on, we take what we've learned from gel Mito 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.

Speaker 4

What we learned about JALMIDO 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, JALMIDO, we immediately follow-up with helping them to operationalize the actual 6 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-one hundred and two approval. What's important also is what's different with UGN-one hundred and two 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.

Speaker 4

So all of that together is we will leverage everything we learned at JALMIDO. 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 an unmet need in low grade intermediate risk non muscle invasive bladder cancer.

Speaker 2

And just to add a couple of things to that. One, remember the rare disease nature of JALMIDO versus the not so rare disease nature versus of UGN-one hundred and two. So all physicians I mentioned earlier see these patients. And you don't need special equipment. It's done by a nurse in the office to your point about the ease of use.

Speaker 2

And we have learned that JAMAITO 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 tract or you've got to have a nephrostomy tube.

Speaker 2

And so I think when you look at UGM-one hundred and two and the ease of use around that and we've heard that from you got the feedback from all the physicians we've spoken to and the practices we've spoken to, it's going to be a very, very different situation. But thanks for the question.

Speaker 10

Thank you.

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.

Speaker 2

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.

Speaker 2

Thank you.

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Key Takeaways

  • UroGen’s NDA for UGN-102 in low-grade intermediate-risk NMIBC was accepted ahead of schedule with a PDUFA date set for June 13, 2025, positioning it as the first potential FDA-approved therapy for this patient population.
  • Gelmato net product revenue reached $25.2 million in Q3 2024, up 21% year-over-year, driven by a 30% increase in new patient enrollments and prescribers, and is expected to deliver low double-digit revenue growth for the full year despite gross-to-net headwinds.
  • Lifecycle management advances include a U.S. patent allowance extending proprietary RTGel technology through 2041, commencement of the Phase III Utopia trial for UGN-103, and plans to initiate a Phase III study for UGN-104 next year, as well as ongoing development of the high-grade candidate UGN-301.
  • Pre-commercial activities are ramping up with a planned expansion of the sales force from ~42 to >80 reps by launch, comprehensive training and reimbursement support, and strategies to navigate interim miscellaneous J-code billing ahead of a permanent code expected in January 2026.
  • Q3 results included a net loss of $23.7 million (-$0.55/share) versus $21.9 million a year ago, a cash position of $254.2 million, and 2024 guidance updated to reflect low double-digit Gelmato growth and operating expenses near the midpoint of prior ranges.
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Earnings Conference Call
UroGen Pharma Q3 2024
00:00 / 00:00