UroGen Pharma Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 14, 2023

There are 11 speakers on the call.

Operator

Good morning, ladies and gentlemen, and thank you for standing by, and welcome to the UroGen Pharma Q3 2023 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 begin.

Speaker 1

Thank you, operator. Good morning, everyone, and welcome to EuroGen Pharma's Q3 2023 financial results and business update conference call. Earlier this morning, we issued our Q3 press release and filed our 10 Q where you can find details for our financial and operating results. Both documents can be accessed on the Investors portion of our website at investors. Eurogen.com.

Speaker 1

Joining me on the call today are Liz Barrett, President and Chief Executive Officer Doctor. Mark Schoenberg, Chief Medical Officer Jeff Bova, Chief Commercial Officer and Don Kim, 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 Gelmido, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercial strategy and expectation as well as potential future commercialization activities for EGN-one hundred and two if approved, anticipated data, regulatory filings and decisions, including UGN-one hundred and two potentially receiving priority review, UGN-one hundred and two being the growth driver for UroGen, if approved, future research and development efforts, our corporate goals and 2023 financial guidance among 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. Liz?

Speaker 2

Thank you, Vincent, and welcome to everyone joining us today. Before we remark on the quarter, I must mention the October 7 attack on Israel and its impact on our Israeli colleagues, partners and investors. The safety of our employees is and will continue to be top of mind. With regard to any potential impact to our business operations, I want to assure our shareholders that while we have a portion of our workforce based in Israel, we have robust contingency plans and international partnerships in place to ensure the continued smooth operation of our business. As a result, we do not anticipate any significant impact on our business or operations.

Speaker 2

Finally, we hope and pray for peace to return to the region as soon as possible. I'll now turn to the quarter. Q3 2023 was one of the most important quarters in UroGen's history. During the Q3, we shared extraordinary top line results from our Phase III clinical trials, evaluating the use of UGM-one hundred and two to treat patients with low grade intermediate risk non muscle invasive bladder cancer. Both the ATLAS and ENVISION trials met their primary endpoints, demonstrating meaningful and compelling results overall and compared to the current standard of care TURBT.

Speaker 2

This is particularly notable because UGM-one hundred and two is being developed as the first non surgical therapy for this type of bladder cancer. Mark will talk more about this, but it's important to delineate the various types of bladder cancer and understand that our products are being studied in patient segments that are not being studied by other medicines. Following this announcement, we held a pre NDA meeting with the FDA to align on the regulatory path forward for UGM-one hundred and two. As expected, the FDA confirmed that the current clinical development plan for UGM-one hundred and two, which includes evaluation of duration of response at 12 months following a CR at 3 months in the pivotal ENVISION trial will support submission of an NDA. The FDA also agreed that our NDA can utilize a rolling review, allowing for early submission of CMC sections of the NDA, which is planned for January 2024.

Speaker 2

Looking ahead, we anticipate sharing data from the durational response endpoint in the Q2 of 2024. Pending favorable results, we expect to submit the NDA to the FDA a few months later. If granted priority review, we anticipate approval and launch in early 2025. If approved, we believe that UGM-one hundred and two would represent a groundbreaking nonsurgical option for approximately 82,000 annual patients suffering from low grade intermediate risk non muscle invasive bladder cancer, who currently face frequent recurrences necessitating the need for multiple surgeries. This potential milestone stands to become a major growth driver for UroGen with a substantial market in the U.

Speaker 2

S. Exceeding $3,000,000,000 Q3 2023 was also the 2nd strongest revenue quarter for JALMIDO and low grade upper tracherothelial carcinoma. We're pleased with the pace of growth for JALMIDO, especially when considering this is a rare disease treated in both community and academic centers. We will continue to drive growth and meaningful adoption through increasing sites of care and leveraging the growing body of real world data, highlighting gelMaito's meaningful value and as part of a multimodal kidney sparing approach to disease management. For the Q3, we reported $20,900,000 in Gelmydo net revenues, an increase of 30% year over year.

Speaker 2

We believe there remains significant growth opportunity for Jomita as the first medicine ever approved for low grade UTUC, bringing a differentiated chemoablative approach to patients. The closing of our $120,000,000 private placement during the 3rd quarter was an important milestone that significantly strengthened our balance sheet. Given our fortified financial position, we are committed to deploying maximize shareholder value and plan to utilize proceeds from the raise to develop and execute a comprehensive pre commercialization and launch strategy for UGN-one hundred and two, while continuing to grow JALMIDO cells. Importantly and based on our latest financial forecast, we believe our current cash position will support our commercial organization through the prospective launch of UGN-one hundred and two. Q3 2023 was a transformative quarter for UroGen, Following strong top line data from Atlas and Envision and our pre NDA meeting with the FDA, we have a clear path forward towards an approval for UGM-one hundred and two in low grade intermediate risk non muscle invasive bladder cancer.

Speaker 2

Meanwhile, JALMIDO continues to grow its footprint in low grade UTUC. I'm very proud of the dedication and commitment across our organization as we remain focused on pioneering a new era in urologic and specialty cancer care. UroGen is at its strongest and most encouraging point in the company's history. I'll now pass the call to Mark, who will provide a clinical update. Mark?

Speaker 3

Thank you, Liz, and hello, everyone. I'd like to take a moment to briefly summarize top line results from the ATLAS and ENVISION trials before commenting on our recent pre NDA meeting with the FDA. As a reminder, ATLAS was an open label, randomized controlled Phase III study designed to evaluate UGN-one hundred and two with or without TURBT versus TURBT alone. The trial enrolled 282 new and recurrent low grade intermediate risk NM IBC patients. Atlas met its primary endpoint of disease free survival with UGN-one hundred and two demonstrating superiority to TURBT with a 55% reduction of risk for recurrence, progression or death in patients who received UGN-one hundred and two.

Speaker 3

UGN-one hundred and two also showed a 65% complete response rate at 3 months for patients who only received UGN-one hundred and two compared to a 64% complete response rate at 3 months for patients who only received TURBT. When we evaluate the subgroup of patients in ATLAS with recurrent disease and a history of at least one prior TURBT, the observed duration of response in the UGN-one hundred and two treatment group was a resounding 66.3% 12 months after achieving a complete response or 15 months post randomization. This is in comparison to 40% duration of response observed in the QRBT arm at the same time point. These results offer compelling insight into the effect of UGN-one hundred and two in recurrent patients, which is the population studied in our pivotal trial, ENVISION. During our recent pre NDA meeting, FDA reaffirmed that ENVISION will serve as the pivotal trial for UGN-one hundred and two NDA.

Speaker 3

ENVISION, which is a single arm study of UGN-one hundred and two enrolled 242 recurrent low grade intermediate risk NMIBC patients with a history of at least one prior TURBT. The study met its primary endpoint demonstrating the patients treated with UGN-one hundred and two experienced an impressive 79% complete response rate at 3 months following initiation of treatment. When looking at the totality of clinical data thus far, UGN-one hundred and two has demonstrated consistency in the 3 month complete response endpoints across all three trials, a consistency and durability of response endpoints in ATLAS and OPTIMA demonstrating a compelling therapeutic and safety profile throughout. For Envision, we maintain our view that a rate of duration of response of 50% or greater is a clinically meaningful outcome in this patient population. Given the consistency and the durability endpoints from ATLAS and OPTIMA, we anticipate potentially similar outcomes for Envision, which we believe would position UGN-one hundred and two for approval in low grade intermediate risk NMIBC.

Speaker 3

Before turning the call over to Jeff for a commercial update, I'd like to briefly comment on this on the recently reported clinical data in bladder cancer from several of our peers. As a company, UroGen's mission is to build novel solutions to treat urothelial and specialty cancers because patients deserve better. We recognize the need for innovation and the development of new therapies in our space. Thus, we are encouraged that there are programs in development that may offer patients potentially better options than the current standard of care. However, as we near the final stages of clinical development for UGN-one hundred and two and with the prospect of commercialization on the horizon, we are discovering how the significant distinctions between low grade and high grade NMIBC and even metastatic bladder cancer may not be widely recognized.

Speaker 3

Low grade NMIBC, high grade NMIBC and metastatic bladder cancer are distinct types of bladder cancer with significant differences. Low grade NMIBC is characterized by less aggressive tumors limited to the lining of the bladder and typically carries a better prognosis. High grade disease on the other hand consists of more aggressive cancer cells within the bladder lining, which may have a higher risk of recurrence and progression. In contrast, metastatic bladder cancer represents the most advanced stage where cancer has spread to distant organs, carrying a poor prognosis and necessitating systemic treatments. The key distinctions lie in tumor aggressiveness, location, treatment approaches, prognosis and the stage of disease.

Speaker 3

It's important to understand that UGN-one hundred and two is focused on low grade intermediate risk NMIBC where the competitive landscape is much less densely populated than in high grade disease or metastatic disease. Therefore, these recent data releases do not impact our current development nor commercial plans nor are expected to encroach on what we believe is a significant market opportunity for this program. We are hopeful that UGM-one hundred and two may potentially serve as the 1st non surgical therapy for this indication, which represents a sizable portion of bladder cancer cases each year and is also characterized by a high rate of recurrence. If approved, UGN-one hundred and two has the potential to shift the standard of care away from repetitive surgical care and may improve the quality of life for tens of thousands of individuals battling this highly recurrent disease. With that, I'd like to turn the call over to Jeff for a commercial update.

Speaker 3

Jeff?

Speaker 4

Thanks, Mark. Q3 was another strong quarter for Gelmyto. We had the 2nd strongest quarter in our history with continued momentum in our underlying business. We saw a small decrease from the prior quarter due to typical summer seasonality and continue to see strong double digit year over year growth in gel myto sales in what is now our 3rd full year of commercialization. Jelmato net sales for the Q3 were $20,900,000 which represents 30% growth from the same period last year.

Speaker 4

This growth in our top line reinforces our long term belief in the low grade UTUC opportunity. During the Q3, further strengthening of the Gelmido ramp and expansion of the Gelmido user base was a result of several key factors, including continued commercial execution. JYALMIDO offers clinical utility alone or following endoscopic management as part of a kidney sparing treatment regime. The meaningful differentiated treatment profile gel In addition, the growing body of data from real world evidence studies continues to strengthen and reinforce GelMido's value proposition, supporting its multimodal use across various practice patterns and diverse presentations. Our experience with gelmito has given us a foundation with urologists by establishing the use of mitomycin and our TGEL.

Speaker 4

Consistent growth and adoption for this product reinforces our optimism for the significant opportunity in low grade intermediate risk non muscle invasive bladder cancer with UGN-one hundred and two. However, UGN-one hundred and two offers several distinct advantages over JELMIDO, including simpler administration and a much lighter operational lift. Delivery of UGN-one hundred and two, if approved, is expected to be easier for urologists given that it does not require the use of specialized equipment, scheduling time in the OR will be delivered premixed with an anticipated 1 week shelf life and can be given by a doctor or support staff in clinic as an outpatient procedure. Importantly, we believe that the reimbursement economics for UGN-one hundred and two relative to TURBT will not be a barrier to adoption. Following the positive ATLAS and ENVISION data, we begun executing our pre commercialization plan in preparation for a prospective UGN-one hundred and two launch.

Speaker 4

With approximately 95% overlap in prescriber base and well established practice patterns, we expect the seamless integration of UGN-one hundred and two into our commercial organization and an expedient launch upon approval. If approved, we anticipate that UGN-one hundred and two will be the first ever non surgical treatment option for disease afflicting approximately 82,000 patients in the U. S. Each year with a total market of more than $3,000,000,000 in the U. S.

Speaker 4

With that, I'll turn the call over to Don to discuss our financials. Don?

Speaker 5

Thank you, Jeff, and thank you to everyone for joining today's call. I'm pleased to review our financial results for the Q3 ended September 30, 2023. We are pleased to report another strong quarter of year over year revenue growth. For the Q3 of 2023, we reported J. Miro net product revenues of $20,900,000 an increase of approximately 30% compared to $16,100,000 in the same period last year.

Speaker 5

For the Q3 of 2023, research and development expenses were $10,200,000 as compared to $13,100,000 for the same period in 2022. The overall decrease is primarily due to lower expenses related to the conclusion of the ATLAS trial and lower cost of ENVISION trial for UGN-one hundred and two offset by higher R and D expenses related to Phase 1 study for UGN-three zero one and ingredient scale up and production for UGN-one hundred and two. Selling, general and administrative expenses for the Q3 of 2023 were $21,800,000 compared to $19,100,000 for the same period in 2022. The increase in SG and A is primarily due to higher marketing, commercial operations, professional services and training, offset by lower commercial back office services and support expenses. Uxian reported a non cash financing expense related to the prepaid forward obligation to RTW Investment of $5,500,000 for the Q3 of 2023 compared to $4,800,000 for the same period in 2022.

Speaker 5

Interest expense related to the $100,000,000 term loan facility with the funds managed by Pharmakon advisors was $3,800,000 for the Q3 of 2023 compared to 2 point $7,000,000 for the same period last year. EuroGen reported a net loss of $21,900,000 or a basic and diluted net loss per ordinary share of $0.68 for the Q3 of 2023, as compared to $25,800,000 or basic and diluted net loss per ordinary shares of $1.13 for the same period in 2022. Turning to forward guidance, we reiterate anticipated full year 2023 net product revenues from JEMIRA to be in the range of $76,000,000 to $86,000,000 We reiterate the full year 2020 3 operating expenses to be in the range of $135,000,000 to $145,000,000 The company reiterates anticipated full year 2023 non cash financing expense related to the prepaid forward obligation to RTW Investments in the range of $21,000,000 to $26,000,000 Of this amount, approximately $9,900,000 to $11,200,000 is expected to be in cash. We ended the 3rd quarter with $153,900,000 in cash and cash equivalents and marketable securities, which includes proceeds from the $120,000,000 private placement, which closed during the Q3. With that, I'd like to turn the call over to the operator for questions.

Speaker 5

Operator?

Operator

Thank And our first question comes from Leland Gershell from Oppenheimer. Your line is now open.

Speaker 6

Hi, good morning. Thank you for taking the questions. Just a few from me. I want to ask Mark in the FDA meeting, did you have any discussion around what range of durability from Envision the agency would like to see when you have those data?

Speaker 3

Leland, thanks for the question. As I think we've discussed previously, our interactions with the FDA indicated that they are interested in and we are going to provide a totality of the data regarding our data sets. And so no specific numerical bar has been discussed as a bar for approval. But it will but the agency has indicated that it will be the entirety of and the clinical meaning of the outcome of these trials that will inform their decision regarding approval.

Speaker 6

Okay. And with respect to the ADLIF data, do we have a view on whether those will be part of, 102 ultimate label at this point? How much of this, I would say, would be the distribution base? Thanks.

Speaker 3

Let me defer to Liz on that.

Speaker 7

Leland, nice to talk to you. Absolutely, the ATLAS data will be in the label. And so yes, we believe that the agency in the meeting talked about that data is supportive of our filing. So yes, we expect that to be in the filing and we expect it to be able to use that data externally.

Speaker 6

Okay, great. Thanks. And just one last question for me. As we had talked in the past about work you have been doing with respect to lengthening your tenants of property runway, wondering if you might have any update on on patent protections for 102?

Speaker 7

Yes. No update specifically except to tell you that you'll hear more in the very near future, and we are on track to do that. And as what we've stated before, it's minimally 2,035, but we actually believe it will be 2,041. So working through final details, but no show stoppers, looks really great, and we hope to provide an update very shortly.

Speaker 6

Okay, great. Thanks so much for the update and taking the questions.

Speaker 7

Absolutely. Thank you.

Operator

And thank you. And one moment for our next question. And our next question comes from Raghuram Selvaraju from H. C. Wainwright and Company.

Operator

Your line is now open.

Speaker 8

Hi, thanks very much for taking my questions and congrats on all the progress recently. I just wanted to get an update on where you folks think you are operationally in terms of identifying any potential efficiencies or cost reductions? And if you think that in particular on the G and A line, we might see some additional evidence of that being realized over the course of the coming quarters? Or if you think at this juncture, you've kind of reached optimum operating efficiency?

Speaker 7

Yes. Look, it's a great question. To be honest with you, you got to remember, we're about to prepare for a launch of a new medicine and one that is projected to be a blockbuster. So we are not looking at reducing important thing we're looking at is how much do we actually have to grow for UGM-one hundred and two and leveraging the organization that we have and obviously shifting some of the focus from JALMIDO to UGM-one hundred and two being the broader opportunity for us from a patient perspective. So I don't really see us reducing expenses.

Speaker 7

In some areas, absolutely. Like an example is in R and D as we look at the ENVISION study and the ATLAS study coming to a close, you'll see some reductions there. But as we've talked about before, to extend the patent life, we'll be looking at adding a study, but it won't be at the same rate. So we'll definitely see some decreases and we'll see some efficiencies across the board, but we're not looking at significant cost reduction in total. But we are being as efficient and trust me, challenging the team internally for particularly on infrastructure ensuring that we're only adding what we need and we're shifting where we can.

Speaker 7

And even looking at things like inventory and how much inventory do we need. The other thing just to sort of note in OpEx is that we have we also are insuring our supply. So we're doing a lot around supply and secondary suppliers to ensure that there's no disruption. And that's obviously some incremental expense, although not significant, but it is something that we want to make sure that we don't have an issue with supply.

Speaker 8

Okay. And then just a bifurcated question regarding the earlier stage pipeline and potential additions to the portfolio. If you look at 2024, can you give us a sense of what you expect to be the most important earlier stage pipeline developments that you're anticipating over the course of next year, particularly if these pertain to valafilumab and also any other potential pipeline programs that you anticipate would likely see notable advancement over the course of 2024, with the exception, of course, of UGN-one hundred and two, which I think is very much at the forefront of people's mind. And if you could also give us a sense of whether you are looking to add anything to broaden the portfolio within oncology via strategic licensing or M and A? Thank you.

Speaker 7

Great question. I'm going to ask Mark to answer the first one and I'll come back and answer the second question. Mark?

Speaker 3

Yes, thanks. So we are advancing the Phase 1 monotherapy program for zalafirlimab, the anti CTLA-four antibody for intravascular treatment in high grade disease. And as we've discussed previously, this is part of a master protocol that will permit us to study combinations with the antibody and we are already in the process of creating those components of the trial. So we would expect next year to be able to talk about our monotherapy experience and update you on how our combination work is going, particularly with our TLR7 agonist as well as potentially with other drugs of interest such as gemcitabine.

Speaker 7

Yes. And I think even from that standpoint to answer sort of the second question, but part of that as well, is we also are looking at other products that are in the market that we would like to combine with and our technology. And so we are having active discussions with external companies, nothing obviously to report right now, but it is a priority for us to your second question. Sure, we would love to bring in something in this space. It's a very active space, as you know, right now, with large pharma, but also in the biotech area.

Speaker 7

I think not likely in 2024 that we'll be doing that, but as we get into 20 25, absolutely. The one thing that's really important about this business to note is this business is a highly leverageable business. When we think about going in and being in uro oncology, you can add multiple products to your portfolio and not have to add meaningfully to the infrastructure. So when you start to get down to 1, 2 years post UGM-one hundred and two, it's a very significant improvement on our bottom line, which will give us the resources that we need to continue to build this company over the long haul. And the only other thing I'll mention is, we also are interested in taking UGM-one hundred and two to high grade disease.

Speaker 7

We're interested in taking UGM-one hundred and two to unwilling, unable in the broader low grade space. So there's a lot of things that we'll start to look at down the road. And I think one of the other things and I introduced Mike Louie is here with us. He's our new Vice President, Medical Affairs and Clinical Development. He's the lead on UGM-one hundred and 2, is also looking at a registry for UGN-one hundred and two, just like we're doing with YALMIDA, and we're seeing a lot of great data coming out of that registry that will start to publicize, and you'll see more publications in 2024 around that.

Speaker 8

Thank you.

Operator

And thank you. And our next question comes from Boris Beaker from TD Cowen. Your line is now open.

Speaker 9

Great. Thanks. Several questions for me. First, from the FDA discussion you've had, did they specifically say why they wouldn't accept ATLAS as a pivotal trial to support approval, just given the very strong hazard ratio and just efficacy data that study has reported?

Speaker 7

Yes. Mark, do you want to answer or you want me to?

Speaker 3

I'll start out and Liz will undoubtedly comment. I think we had originally planned to enroll a larger number of patients in the ATLAS trial, substantially larger than we ultimately enrolled. The data are very strong, but I think the fact that we halted enrollment to continue the trial with a smaller number of patients than originally anticipated in the original statistical analysis plan probably inform some of the FDA's position on the aggregate value of the ATLAS data as a standalone submission. But Liz may want to comment as well.

Speaker 7

No, I think that's right. Look, we tried, we the data is very compelling. Their initial stance on the data is exploratory. We made very clear that it is not exploratory data. It is significant data.

Speaker 7

They did come around to that way of thinking. But given that the if you think about it from a prospective statistical analysis plan, we didn't reach the endpoints that we would have needed to reach to for that to be the pivotal study. So they just came back to I will say and Mark can say this as well is it was a very positive study. It's probably the meeting with them. It was the most positive they have ever been.

Speaker 7

They were very impressed with the data. There was no pushback on the Envision, only we want to see durability, which frankly not only have they said that to us, they've said it to everybody else in this space. We want to see durability. You hear that every time you hear us about somebody in bladder cancer. So it was really more a matter of prospective analysis plan and not being able to have that data in hand.

Speaker 7

But again, very positive interaction. But they've been very clear all along that they want to see durability and durability as is as important to them as CR. But that was it. I mean, we did try Boris. I mean, it was obviously, we felt like compelling enough data, but we understood and we knew that it was a probability that they would say you've got we want to see the Envision Durability Day, which is exactly what they said.

Speaker 7

So we feel like we're in a very, very strong position with them and knowing exactly what they want to see, when they want to see it, and we're marching toward that.

Speaker 9

Great. And my last question here, you mentioned reimbursement economics that the 102 is more favorable than TURBT. Can you just talk about what those reimbursement economics are in various setting, maybe in academic centers versus private practices or however you want to divide that?

Speaker 7

Yes, sure. Jeff will take you through that.

Speaker 4

Hey, Boris. Yes, so depending on the size of the tumor for TURBT, there isn't a significant amount that's reimbursed to the physician. I do think there's maybe a perception that it's larger than what it is. But if you would look at the reimbursement economics and you couple in installation of an anti carcinogenic, which would be UGN-one hundred and two times 6 as well as the buy and bill portion of the drug, which will be given in the clinic predominantly. So the physician would see that buy and bill versus a hospital.

Speaker 4

The economics look very good when compared to TURBT. I do I don't people need to understand that surgeries or reimbursement for surgeries has gone down and we see that as evidence of a TURBT, obviously, depends on the size of the tumor. But overall, the reimbursement, we expect for 102 to be better than TURBT.

Speaker 7

Yes. And then look, the only thing I'll comment about is we are not going out with a profitability message, right? That's not our message. We can't do that. We won't do that.

Speaker 7

But it will be very you're right, Bora. It will be very important to them that they don't feel like they're losing money. That's it's not a detriment to them, even though we know it's better medicine for the patient, which we'll focus on. But we do have field reimbursement managers. We will make sure that our reps are also armed and able to share the information that we can appropriately share because it is an important piece, as you know.

Speaker 7

Unfortunately, decisions get made that way, but this is will be frankly a net positive if they use it from a financial standpoint. But keep in mind, obviously, our role and how we discuss that to the marketplace.

Speaker 9

Great. Thank you very much for taking my question.

Operator

And thank you. And one moment for our next question. And our next question comes from Paul Choi from Goldman Sachs. Your line is now open.

Speaker 10

Hi, thank you and good morning and congrats on the good quarter. I was just wondering for Mark, if you could maybe share any additional feedback you've had from the physician community since the Investor Day, specifically since the Society of Urologic Oncology is coming up here, any additional feedback you've gotten on Envision and Atlas? Thank you.

Speaker 3

Paul, thanks for the question. And I may actually lean on Jeff as well to talk about this. But I think people are excited about the possibility of the approval of 102. Think everybody, specifically folks who work in urologic oncology understand the need and specifically the unmet need in this population. So what I'm hearing from colleagues is anticipation that's positive.

Speaker 3

But Jeff, I don't know if you have additional.

Speaker 6

You

Speaker 7

want to talk about what some of the feedback you got at LUGFA?

Speaker 4

Sure. So we just got back, hi, Paul, from LUGFA annual meeting, the larger groups. We had an advisory board there, where Doctor. Prasad presented some of the data that we saw out today. And I think the initial reaction was overwhelmingly positive.

Speaker 4

It was designed to sort of get their feedback in and around the data. We workshopped a couple different patient types. But they're eager to have a different option. If you're on the conservative side of things, they certainly have a number of patients that they do not want to put under general again and have a surgery. So there's that.

Speaker 4

And then many of them reiterated that essentially with looks like in at least in Atlas, it's the same for TURBT and it's a much longer duration of response, which is obviously a key attribute if approved for UGN-one hundred and two. So that was 12, 13 advisors, very influential in the community. They gave us really strong feedback. We'll continue to obviously engage as we need that feedback, but that was just an initial reaction.

Speaker 10

Okay, great. Thanks for that color. And as a follow-up also for you, Jeff, just regarding your comments on the buy and bill process, can you maybe just us some sense of what you think the runway will be before reimbursement and J codes and so forth are established for 102? And just how you think the early mechanics might look like starting with a launch in 2025? Thank you.

Speaker 4

Sure. As with any Part B drug, you will have we will have a miscellaneous code for a period of time. We did with JALMIDO. We expect that with 102 as well. As with any miscellaneous code, it's a manual process.

Speaker 4

So we have to really make sure that we're buttoned up

Speaker 6

on making sure that we support the office

Speaker 4

on how they fill everything out clearer than, gelmito because with gelmito, you had to bill for both drug and waste. So you had a miscellaneous drug code, you had a miscellaneous waste code. Here you won't have as many line items. So it will be much more straightforward. We will put things in place to sort of help with the anxiety in and around the miscellaneous code.

Speaker 4

We do expect, if approved in the time line that we think we're going to get the nice thing is CMS is reviewing miscellaneous codes more than once a year now. So we expect a J code hopefully sooner because of that review process. But we will put those things in place to get past that. But I always say it's a miscellaneous code. It takes a little bit more time on the physician, the physician practice.

Speaker 4

You'll have your early adopters that will come out and use it and hopefully be reimbursed accurately. We can then share that. They'll talk to their peers. And then hopefully by then we have a permanent J code.

Speaker 10

Great. Thank you.

Operator

And thank you. And I am showing no further questions. I would now like to turn the call back over to Liz Barrett for closing remarks.

Speaker 7

Thank you, and thanks to everybody for your continued interest in UroGen. I think it's been a tough market the last few weeks, but as everybody has seen that we've made significant progress. We continue to make significant progress, both on JALMIDO and then importantly on UGM-one hundred and two. So appreciate, we have a lot of key catalysts coming up in the next 6 months. So appreciate your interest and we'll keep everybody posted.

Speaker 7

Thanks a lot. Appreciate it. Operator, you can now disconnect.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

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Key Takeaways

  • In Q3 2023, UroGen announced positive top‐line results from its Phase III ATLAS and ENVISION trials of UGN-102 in low‐grade intermediate‐risk NMIBC, demonstrating superior disease‐free survival and complete response rates versus TURBT.
  • Following a pre‐NDA meeting, the FDA agreed to a rolling review for UGN-102, with CMC sections to be submitted in January 2024 and potential priority review paving the way for an early 2025 launch.
  • If approved, UGN-102 would be the first non–surgical therapy for approximately 82,000 annual low‐grade intermediate‐risk NMIBC patients in the U.S., targeting a market opportunity exceeding $3 billion.
  • Gelmyto net product revenues reached $20.9 million in Q3, up 30% year‐over‐year, marking the company’s second‐strongest quarter and highlighting continued adoption in low‐grade UTUC.
  • The $120 million private placement closed in Q3, combined with $153.9 million in cash, extends UroGen’s runway through the prospective launch of UGN-102 and supports ongoing R&D investments.
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Earnings Conference Call
UroGen Pharma Q3 2023
00:00 / 00:00