Q4 2022 Urogen Pharma Ltd Earnings Call
Speaker 1: The conference will begin shortly.
Speaker 2: Good day, and thank you for standing by, and welcome to the EuroGen Pharma Q4 2022 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session.
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Speaker 2: 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 3: Thank you, operator. Good morning, everyone, and welcome to Eurogen Pharma's fourth quarter and year-end 2022 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and preliminary financial results.
Speaker 3: for the quarter ended December 31, 2022.
Speaker 3: The press release can be accessed on the investors portion of our website at investors.erogen.com.
Speaker 3: Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, Jeff Bova, Chief Commercial Officer, and Don Kim, Chief Financial Officer.
Speaker 3: During today's call, we will be making certain forward-looking statements.
Speaker 3: These may include statements regarding our ongoing commercialization activities related to gelmido, anticipated seasonality for gelmido in 2023, our ongoing and planned clinical trials, commercial and clinical milestones in the year ahead, the potential of UGN-102 to transform the treatment paradigm as the first non-surgical treatment for gelmido.
Speaker 3: our optimism regarding multiple avenues available to us to further strengthen our balance sheet, and 2023 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SCC disclosure documents.
Speaker 3: You are cautioned not to place undue reliance on these forward-looking statements in your urgentist claims and the obligation to update these statements.
Speaker 3: I will now turn the call over to Liz.
Speaker 4: Thank you, Vincent, and thank you everyone for joining us today. Looking back on 2022, I'm proud of our progress and more enthusiastic than ever about the future of eurigen. We return to growth in Q4, delivering our strongest quarter ever for GelMito, ending the year with $64.4 million in net product revenues.
Speaker 4: representing a 34% increase from full year 2021. This bodes well for UGM-102 as we continue to think of gelmido as proof of concept and the gateway for the much larger market of bladder cancer.
Speaker 4: That belief is substantiated by the incredible momentum we experienced in our UGM-102 clinical trial. In just 20 months, we've enrolled over 500 patients between both the ATLAS and the Envision Phase III trial. In fact, we completed enrollment of Envision, our pivotal study for UGM-102, for the treatment of low-grade, intermediate-risk non-mucumbasive bladder cancer in less than a year.
Speaker 4: an update on complete response and durability in Atlas while also providing the primary endpoint of complete response rate in the envisioned study.
Speaker 4: Assuming positive results, these studies will form the basis of our FDA submission in 2024 plus durability has matured.
Speaker 4: UGM-102 is designed to address a much larger patient population, and administration is much simpler, without the need for fluoroscopy. Therefore, if approved, we anticipate UGM-102 will prove to be our main growth driver in the future.
Speaker 4: At the end of last year, we shared long-term follow-up data from the Jomito Olympus Pivotal trial and the Phase IIb Optima II study of UGM-102. In each of these, we observed a greater than two-year median duration of response. Along with a recently completed small home installation study, we found that the
Speaker 4: encourage almighty and expect revenue growth in 2023 to reflect growth of 20 to 30 percent over 2022 and revenues of 76 to 86 million dollars.
Speaker 4: While we ended the year strong with $100 million in cash, we continued to reduce cash spend and focus on our core assets.
Speaker 4: Especially given the market potential for UGM 102, we are optimistic that we will be in a position to explore multiple avenues to further strengthen our balance sheet when necessary.
Speaker 4: Overall, I am very enthusiastic about the progress we've made in 2022 and the road ahead as we plan for an FDA submission of UGN 102 in 2024. We believe JALMIDO and UGN 102 together represent a billion dollar revenue opportunity for Urogen and remain focused on solid execution to turn that belief into a reality.
Speaker 4: With that, I'll pass the call over to Mark to further update you on our clinical development program. Mark? Yeah.
Speaker 3: Thank you, Liz, and welcome everyone. My comments will underscore Liz's remarks and reinforce our excitement as we advance our lead pipeline program, UGN 102, and highlight recent real-world data from gelmido. As you may recall, we commenced the international multi-center registrational and vision study pipeline.
Speaker 5: in January of 2022.
Speaker 5: The study is intended to evaluate the efficacy and safety of UGN-102 as primary chemo-ablative therapy in patients with recurrent low-grade intermediate risk non-muscle-nasive bladder cancer. As Liz noted, we expect to report out this data by the end of this summer.
Speaker 5: The quickness with which we were able to complete this trial is a testimony to the interest from urologists for a new alternative for treating bladder cancer. Our confidence in the potential outcome of InVision stems from its similarity to the Phase II Optima II trial of UGN-102, which demonstrated a 65% CR rate and duration of response.
Speaker 5: 12 months of 72.5% using Kaplan-Meier analysis.
Speaker 5: UGN 102 also has key similarities with Chymito. Both products utilize minomycin, allow for local delivery, and sustained exposure to minomycin for up to 6 hours. And importantly, both low-grade NMIBC and low-grade UTUC.
Speaker 5: share many biological and clinical similarities, which leads to common clinical features, including the responsiveness to chemotherapy. UGN-102, however, has many important advantages over gel mito, which we believe will have a direct impact on its use.
It does not require special equipment for procedures and is designed to be instilled into the bladder via urethral catheter in an outpatient setting. A common and routine procedure in most urology practices.
This advantage will be critical as low-grade intermediate risk in MIBC is eight to ten times more common than a condition that is routinely managed by eighty to ninety percent of urologists.
inferring a significantly larger addressable patient population.
We recently shared results from a small study that demonstrated the suitability of UGN-102 at home by a visiting nurse under the supervision of a treating physician.
6 of 8, or 75% of patients who received 6 weekly doses of UGN-102, achieved a complete response, defined as no detectable disease after 3 months of starting treatment.
Treatment-related adverse events were mild to moderate, and the few serious adverse events were not treatment-related.
We anticipate a small subset of older patients with social challenges may benefit from being treated at home versus in clinic, and the results from this study provide us with added confidence that our novel investigational therapeutic has the potential to address genuine unmet needs for low-grade bladder cancer patients.
In December , we shared new and supportive long-term follow-up data from the Optima II study of UGN 102 at the annual Society of Urologic Oncology meeting. The study showed a greater than 24-month median duration of response with UGN 102 in 15 of 35 invaluable patients.
Long-term follow-up data from Jill Meito's pivotal trial were also presented at SUO.
The study showed a greater than 28 month median duration of response in 16 of 23 of valuable patients. Together these studies added to the growing body of evidence supporting the potential for long-term recurrence free survival associated with R-key gel delivery of mitomycin to the bladder and urinary tract.
to treat low-grade urethral cancer.
2023 is shaping up to be an important year for UGN 102 with multiple near-term catalysts, including POPLINE data from the ATLAS trial, the precursor to InVision, which enrolled 282 patients who completed treatment with either UGN 102 or primary TURBT.
top-line results from the Phase III Envisioned trial mid-year, and assuming positive results from the Phase III trial, preparing for an NDA submission with the FDA in 2024. The goal would be to target priority review, which, if granted, may potentially result in approval at the end of 2024 or early 2025.
If approved, UGN-102 will be the only primary non-surgical therapy addressing the nearly 80,000 new patients in the U.S. alone who will undergo repetitive endoscopic resection and are burdened with the risks of surgery and anesthesia as their only recourse for disease control. As a practicing neurologist who cares for bladder cancer patients, I am very grateful to the U.S. Department of Health and Human Services.
This would be a transformative therapeutic advance that I believe will be welcomed by my colleagues and patients alike.
Meanwhile, our phase one trial with UGN 301, our in-licensed anti-CTLA-4 antibody for intervesicle administration using RT-GEL technology, continues to enroll. UGN 301 is in development for use in combination with other immunomodulators, including UGN 301, our proprietary PLR7 agonist.
and other potential chemotherapy and immunotherapies to treat high-grade non-muscle nasal bladder cancer.
This study is aimed at identifying the suitable dose for a subsequent phase 2 trial.
The first arm of this study evaluating dose ranges of UGN-301 as monotherapy is expected to be completed in the second half of 2023. We view UGN-301 as a cornerstone checkpoint inhibitor for a variety of potential combination therapies targeting high-grade NMIPC. In closing, 2023.
will be an important year as we look to build upon the foundation of real-world evidence and clinical data supporting our increasingly compelling and well-established technology and product portfolio of innovative non-surgical therapies for urethral cancer.
And with that, I'll hand the call over to Jeff to provide a commercial update. Jeff? Jeff, are you there?
Thank you, Mark. Q4 represented our strongest quarter performance ever for GelMito. I'd like to take a moment to highlight a few of the underlying factors which contributed to our performance in the fourth quarter.
Adoption metrics continue to demonstrate encouraging trends in new and repeat accounts, indicating clinical conviction from gel-mito adopters and growth in new users. The predicted sites on March 1, 2023 were 983 compared to 930 on November 1 of last year.
and repeat accounts were 214 compared to 177 for the same period. This is a 21% increase over the last period.
Reimbursement remains at approximately 99% across all coverage types.
In Q4, we saw strengthening of the JoeMito ramp and an increase in uptake in several key territories. In Q4, we saw strengthening of the JoeMito ramp and an increase in uptake in several key territories.
This was driven in part by strategic adjustments to our sales strategy discussed last quarter, including the addition of operation support to facilitate logistical efficiencies and alignment of our field sales team with the appropriate drug and device skill set.
We expect the benefits of our revised strategy to deliver sustainable growth in developing territories and are encouraged by the impact scene thus far.
Our performance in Q4 also reflects operational efficiencies from the September 2022 label update which extended the stability period of gelmito admixture from 8 to 96 hours.
We've seen an immediate positive impact to several logistical challenges, including allowing for delivery of the admixture the day before installation, enabling HCP preferred for early morning installation.
This has led to a shift of approximately 50% of doses to day prior delivery, facilitating expansion of the geographical coverage of our mixing partners and optimizing our territory business manager's time in the field.
The growing body of outcomes from real-world evidence data continues to reinforce gel mito's efficacy and safety.
In addition to supporting a multimodal approach of GelMito across multiple use cases,
The recent independent multicenter retrospective analysis has answered a number of questions not addressed by Olympus.
arming our commercial organization with a deeper understanding of Gelmitos use across various practice patterns. Further, outcomes from this study add to the growing body of real-world data demonstrating a favorable safety profile and additional benefits of anti-grade administration.
which now represents approximately 60% of gel mito installations.
After two years of market experience with Telmito, we expect to see stability going forward with respect to quarterly variability or seasonal dynamics.
as we get back to a new sense of normal.
Looking ahead, we expect typical payer dynamics in play in Q1 resulting from deductible resets, followed by stronger demand in the second quarter, slight delay in Q3 as we expect PEP conversions to slow in the summer months.
followed by stronger Q4 as path conversions return to baseline.
GelMido is undeniably gaining traction and adoption appears to be accelerating as the product becomes increasingly proven, easier to administer, and incorporated across multiple practice patterns. This is done to transform the quality of the Inspiration 5 data you have generated in view
This reinforces our optimism and lays the foundation for the potentially much larger opportunity with UGN-102 in low-grade, intermediate-risk, non-muscle invasive bladder cancer.
With 95% overlap in the prescriber base and well-established practice patterns, we expect a seamless integration of UGN 102 into our commercial efforts, if approved.
With that, I will turn the call over to Don to discuss our financial results. Don? Thank you, Jeff, and thank you to everyone for joining today's call. We finished the year with growing momentum, delivering our strongest quarter ever for Jeremiah Tonesti. On an annualized basis, Don and John formed a long term capital F…]
revenue from Jeremiah Tosei's growth grew 34% in 2022. For the fourth quarter of 2022, we reported Jeremiah and Ned revenues of $18.1 million compared to $16.1 million for the same period in 2021.
On a full year basis, we delivered gelmiter net revenues in line with consensus estimates of $64.4 million compared to $48 million for the year 2021. Our performance reflects a strengthening ramp and growing adoption of gelmiter.
For the fourth quarter of 2022,
Research and development expenses were $14.4 million as compared to $13.1 million for the prior year quarter.
Full year 2022 R&D expenses were $52.9 million as compared to $47.6 million for the full year 2021.
The increase in R&D expenses of $5.3 million is primarily attributable to higher research and development expenses in 2022 related to Phase III Envisioned Study for UGN 102, research into ingredient scale-up and production efficiency for Jeremiah.
partially offset by lower stock-based compensation expenses in 2022.
For the quarter of 2022, selling, general, and administrative expenses were $21.6 million compared to $21.4 million for the prior year quarter.
Full year 2022 selling general and administrative expenses were $82.9 million as compared to $87.5 million for the full year 2021.
The decrease in SJNA related expenses of 4.6 million dollars resulted primarily from a decrease in stock-based compensation and compensation related costs in 2022 offset by brand marketing related expenses.
For the fourth quarter of 2022, we reported financing expenses related to the prepaid forward obligation to RTW investment of $5.1 million.
Financing expense related to the prepaid forward obligation to RTW investments totaled $21.6 million for the full year 2022.
The cash payout rate for 2023 will be 13% based on $64.4 million of global net product sales of Jeremiah in 2022.
We anticipate
Full year 2023, JMI to net revenues to be in the range of 76 to 86 million dollars.
Full year operating expense is expected to be in the range of $135 to $145 million including non-cash share-based compensation expense of $6 to $11 million subject to market conditions.
We will continue to scrutinize all expenses in support of our efforts to prioritize catch preservation.
Financing expense related to the prepaid board obligation to RTW investment.
is expected to be in the range of 21 to 26 million dollars of which approximately 9.8 to 11.1 million dollar will be paid in cash.
In addition to RTW financing expense, interest-only payments on the $100 million Tom Lomé In addition to RTW financing expense, interest-only payments on the $100 million Tom Lomé
We ended the year with $100 million in cash and cash equivalent, which is expected to finance operations into the first half of 2024. To echo Liz, we are committed to diligently and proactively managing our balance sheet in support of our commercial and clinical development activities.
We will continue to watch revenues and monitor expenses closely while also routinely evaluating our cash position and capital market environment to the need to opportunistically strengthen our balance sheet arrive. With that, I would like to turn the call back to Li for closing remarks.
Thank you, Don. I'd simply like to close by expressing my pride in all that we have accomplished and continue to execute on from the leadership right through to the entire Urgent team. I'd also like to express my sincere thanks to those individuals as well as to the patients and clinicians who have contributed to this work. This is an honor for Ryan and
that are realizing the benefits of gel-mito adoption and the diligence of the investigators and patients participating in our ongoing clinical trial. Finally, I'd like to thank and reiterate our commitment to our shareholders who see the importance of the goal that we are trying to achieve.
We look forward to keeping you all apprised as important events continue to unfold over the weeks and months ahead.
I'll now turn the call over to the operator for a Q&A session. Operator? System of Digital
And thank you. As a reminder to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q and A roster.
And one moment for our first question.
And our first question comes from Leland Gerschel from Oppenheimer. Your line is now open.
Hey, good morning guys. Thanks for taking the questions and congrats on the progress. Two questions for me. First for Mark, you know as we'll wait for the durability data from Envision, obviously early next year after we get the response top line, and any reasons we should think that would differ than what we saw from what we saw in
And then, second question for Liz. You just teeing off the comments you made about the signs of the UGN 102 market opportunity providing potential opportunities to strengthen the balance sheet. Just wondering if that should lead us to think about any sort of visit development or strategic development that you see at the outset or at the joint executive?
arrangements you may be contemplating down the road with UGN 102 as you get to commercial. Thanks. Okay, thanks, Leland. Mark, why don't you answer and then I'll come back. Thanks, Leland. Good morning. So the short answer is no, just to remind the listeners.
In Optima, about 25% of the cohort studied were patients with de novo disease. The remainder are those patients who had recurrent disease. In Vision, all patients will have had recurrent disease. When we evaluated this question as to whether or not there was a difference between new and recurrent responses to UGM-102 in the Optima cohort, we were not able to discern a difference.
based on that cohort. So our expectation is that in the Envision trial, we will see very similar results what we reported in Optima.
And, you know, to answer your question, Leland, I mean, to be honest with you, we're looking, you know, we're always opportunistically looking at everything. So whether it be BD, a strategic partnership, you know, other forms of capital. So we just, we want to make sure that, you know, we keep doing the diligence around our expenses and, you know, we have other.
it was really going to accelerate our growth. And so we'll continue to look at that as well as a lot of other options as well. But nothing has been decided. We haven't, we just feel like, given that the data is coming up this summer, that that's probably a good time to think about doing something. So thanks for the question.
Great, thanks for the idea Alexander.
Thanks for the welcome. And thank you.
And one moment for our next question. And our next question comes from Mitchell Kapoor from HCW. Your line is now open.
Hi everyone, this is Mitchell on for Ron. Thanks for taking our questions. The first one is, I just wanted to ask about the main driver of GelMito uptake now and how that's differed since the original launch and how does the company intend to optimize the value of XUS? Jeff, you want to take that and then I'll take the XUS question.
Sure. So, hi, Mitchell. The main driver continues to be patient identification, getting into the offices and really sitting down and looking at various codes that help identify patients that could benefit from gelmido. The data to continue to get better, we continue to continue to provide full access to new products.
to do that. And then physicians, as you saw from the number that increased from repeat users, they also, once they get experience, they also look for other patients in the practice. We obviously have this data will be out there in the hands of the field. So prior to Q4 that we just reported, this data wasn't available. So we're certainly excited.
about the pieces of data, the long-term follow-up, the Waldo, which is the retrospective, as well as the Rose Paper, which talks about additional anti-grade installations, to continue to help us with – get in. New data is always a positive. It allows access. towel wrap
Physicians are going to be very and have been very interested in hearing about the new data since the real-world evidence is really how they're using gelmito, which, as you can see, is oftentimes endoscopic resection, getting what they can see, understanding that there's microscopic disease that they couldn't see, and coming back with sick doses of gelmito. And on the XUS question, I think, you know, as we've talked...
And so because we prioritize the work that we're doing here in the US for obvious reasons, so we see that down the road, but we absolutely see an opportunity to do more clinical work that would get us global, give patients, frankly, global access.
And right now we do have a named patient program. We actually have had a lot of success with a few patients that have had good results after using it through the named patient program. Because one piece of actually getting government to pay is when physicians start asking for it. So with a named patient program and them getting some experience with that and their ability to be able to see links in the input form.
And on 102, I just wanted to ask if the commercial strategy will require any additional infrastructure in the US.
Yeah, Jeff, do you want to just talk about sort of our thoughts around that? Sure. Well, because there's a 95 percent overlap in key targets, it will not require a significant resource expansion. We'll always take a look at larger geographies to cut down on windshield time.
But because the overlap is so significant, I don't see a reason for a larger major expansion with the hopeful approval of 102.
Okay, great. Thank you all. And thank you. And one moment for our next question. And our next question comes from Paul Choi from Goldman Sachs. Your line is not open.
Hi, this is Roderick for Powertroid. Thanks for taking our questions. So the first question is, what could drive further adoption of Gemalto in 2023 and maybe potentially reach the higher end of your guidance? And maybe another question is, how do you make sure that the
in 2023 to anticipate to report additional real-world data, including maybe the physician's feedback based on the stability change in the label in this year. Thanks. Thanks, Jeff.
Sure, I think the three pieces of data, actually four, are going to drive greater adoption in 2023. I'll start with the operational data that we have that the FDA approved an 8 to 96 hour stability period. That's already resulted in 50% of doses being delivered a day prior. That's already resulted in 50% of doses being delivered a day prior.
So we've been able to reengage physicians that may have been a little reluctant to adopt gelmido because of the eight hour restriction. The second is certainly the question on long term follow up. How long do patients stay disease free? And we've been able to, you know, from the Olympus data, follow a number of those patients.
but now we see long-term follow-up with a median of 29 months. I think more importantly, the two pieces, the real-world evidence, talked about how physicians really practice. That's going to be key and to go in and be a partner with multimodal, what we use, we use the term multimodal, be a partner with endoscopic resection.
And so, for those physicians that may have only been resecting and holding off on using gelmido, you'll be able to go in and talk about the difference in CR. When I say that you, the representatives will be able to get in and talk about the difference in CR, the increase in CR. And then finally, the Dr. Rose paper with 32 patients.
showing only a 9% stenosis rate with antergrade administration versus the 44% that we saw in Olympus. So all of those key pieces of data give me confidence that we're going to see growth in 2023 from that.
I think what Liz, I'll just add one more comment around the 96 hours. The other thing that 96 hours does for us is it actually frees up our rep. Because in a lot of cases, you know, when you only had eight hours, the rep had to make sure that the dose got to the doctor's office on time.
or the hospital, wherever it was going. And now that we have more time, they don't have to worry about that. And so that's actually very helpful. So they can spend their time actually out generating more patients, generating demand, versus really babysitting the dose to make sure it gets to the doctor's office. But thanks for the question.
Thank you. Thank you.
And one moment for our next question. And our next question comes from Boris Beaker from TD Cowan. Your line is now open. Your line is now open.
Great, thanks. This is Nick on for Boris. I just have a quick question or quick two questions on the Atlas trial. Will you be releasing the TURBT patient data from Atlas? I know that you're planning to release about 280 patients worth of data. Does that include TURBT? Yes, that's correct.
And then also from the UGN-102 arm of the Atlas trial, will this allow for a potential read-through to the InVision trial?
Mark, do you want to give your perspective and then I'll add in commentary? Sure. Thanks for that question.
The answer is that we will be releasing the data from the TUR arm as well. I would caution everybody to remember that because the study is underpowered, we will not be able to compare the arms. However, it will give us a sense in this cohort of the performance of surgery and probably as or more importantly, the performance of the TUR arm.
safety issues around surgery in this population, which is an area of some interest and study in our community right now. And then secondarily, in the 102 arm, I think we have said on multiple occasions we will be providing complete response and durability data as well as safety data for that group of patients.
And with caveat again about not being able to compare arms, we do believe that given the substantial comparability of this population to the optimum population reported in our phase two experience, we believe that it will be supportive and directionally in line with what we've previously reported and what we would expect to see in the envision cohort as well.
right in efficacy because you have a much, much bigger patient population. So we'll see. But we believe, to Mark's point, that it will be, you know, that will definitely, you know, be aligned in that case. The other thing is I just also want to caution everybody on the data that we will share, because we will share top-line data, but we will not share all of the data, mainly just because we want to get a publication, you know, a peer review in a peer review journal.
and we want to present it at a meeting, and you know that if we give all of the data, then that won't happen. So we will give top-line data. We won't go into all of the details, but we will get that out in a paper presentation as quickly as possible.
So thank you for the question. Yeah, thank you very much. Just on UGN-102, the at-home administration, do you plan to run an additional trial for this? Or, like, is this more so going to be just for physicians to see and potentially then use if they need to? Yeah, we're not planning to run.
you know, bringing it home and, you know, we think that there will be an opportunity in the future. But the reality of it is that most patients, and we even saw that even in that study, most patients want to go into the doctor's office. And so, but we do think, you know, maybe in nursing homes and there's opportunity. So I think we'll see what the demand is for.
And there's not going to be anything in our label that wouldn't allow for home delivery through a nurse, a home health nurse, just like they get other things through home health today. So I'm not sure that we need a study to be able to do that.
Great, thank you very much. Thank you. And thank you.
Great, thank you very much. Thank you. And thank you. We'll begin in one moment by our next question.
And our next question comes from Matt Kaplan from Lattenberg, Your line is now open.
Hi, good morning and thanks for taking the questions. Just to dig in a little bit more to Joe Mito and the revenue guidance and specifically potentially returning to more accelerated growth of Joe Mito. Can you talk a little bit about the trends as a whole being um
the current use and adoption of the nephrosmosis in terms of administration of Selmaito and what are your thoughts kind of going forward in terms of that helping to drive growth further. Jeff.
Sure. Thank you for the question. It continues to go up. You listen every quarter, it goes up a certain percentage, you have five or 10 percent. I think with the Dr. Rose paper, you're going to see a bump in physicians that maybe have been a little reluctant, if they just really wanted more data. Now, 32 patients, you have a similar, if not better.
and then you have, most importantly, is a reduction in stenosis. I don't ever – I can say for a fact it will never be 100 percent of the installations. Sometimes patients don't really want the catheter in their back for six weeks. So there will always be a subset of retrograde installations. But I do see it continuing.
what we see is usually their first attempt at Antigrade leads to future attempts at Antigrade. So as they identify patients, they no longer give it in a retrograde fashion. They've moved their administration to strictly Antigrade.
And then a follow up with respect to the impact on the stability period. When do you think you'll, obviously it's early in the label change, but when do you think you'll see kind of a full impact on improving adoption and driving this? I think Q2. We've already seen it go from 20%.
to 50% in a short period of time of day before installations. I think you're going to see that continue to increase. Look, some physicians still don't need it the day before, just depending on when they want to do the procedure. But I think what it does is if 50% or the day before, it's freeing up, as Liz alluded to earlier.
really ensuring that operationally the dose arrives. So as our independent pharmacies and our partner pharmacies, the mixer that we currently use, adopt and get used to mixing later in the day and delivering it later, that'll continue to become more efficient. And we'll follow the guidance of the practice. If they were required the day before, we'll continue.
I was just going to comment to your question around the growth. I think what we have said and I think what we continue to see is slow, steady growth. So, unlike, you know, will there be a time where you'll see a hockey stick in selection point, we don't think so. We think that it will continue to grow. We're seeing that. We're seeing more stability, more consistency.
and you'll continue to see that. And I think that is reflected in our guidance for the year. But we're happy about that. It's good to see that consistent growth. But we don't think that, even given the great data that we have, we think we'll continue to get more and more physicians. And we've been adding physicians every quarter. We add physicians, new physicians. And it does get back to what Jeff said earlier around finding the patients. Again, there's 6,000 to 7,000 of these patients.
to the product and the rate lending staff, whether it's a PNC or long-term follow-up, what's the rate lending staff going to do to finally go through and approve it? Yeah, it really is durability, waiting for durability. The agency was very clear, and we talked about that as well.
that durability is very important. So even though complete response is our primary endpoint, a key secondary endpoint is durability. And the FDA wants to see some strong durability data. So we have to wait until, remember, we look at CR after three months from the time they started therapy, and then we need all of those patients to have a minimum of 12.
post their CR, and that will give us some strong data in which to go forward to the FDA. So, that's really what's driving the timing. CMC, knock on wood, in this case, because it is so similar to Delmito, we don't really foresee any issues there. We think that will go very smoothly.
And so it really is just a matter of the clinical data and getting the database cleaned once we get the durability and having that data to go forward. So we haven't given a time exactly of when we're going to file. It is also an event-driven study, right? So in addition, we have to know we have.
a certain number of events as well. And so that's what will drive it. So we're comfortable saying 2024. And we're, you know, we're comfortable saying that, you know, it's given priority review, you know, we could, you know, could potentially get at the end of 24 or beginning of 25.
So, durability data for SAVA 24, is that the expectation? Yes, exactly, absolutely.
Okay. Thank you. And then last question in terms of 301. What will you be looking for on the data of 301 when that reports out over the field? Yeah, Mark, you want to talk about 301? Yeah, sure. Thanks, Matt. So, what we're currently doing is dose-escalating 301.
And that obviously is predominantly a safety experience for the appropriate dose. So the initial finding is going to be the appropriate dose. Subsequently, our plan, as I think you know and others do, is to combine this with other immunomodulators and chemotherapeutics. So ultimately, though those data will not be forthcoming this year, hopefully in the near term we'll be able to share.
combination data that would provide evidence of efficacy in this high-grade population, which is obviously different than the gel-mito and UGN-102 populations we've been focusing on. But for right now, what we're focusing on is finding the appropriate dose and demonstrating safety.
Thanks a lot, guys. And thank you.
All right, thanks a lot, guys. And thank you. And one moment for our next question.
And our next question comes from AJ Velasquez, male, from Jeffries. Your line is now open. Thank you for your half a minute for answering this,?"
Hi, y'all. This is AJ for Chris Harrison. Just one additional question here. For the Envision trial, what gives you confidence that a single-arm design is sufficient for approval, and would you consider, or could you get, like, a SPA agreement with the FDA? So, Mark, do you want to talk about the feedback we got from the FDA, and I can also...
So on the strength of the Phase II data, as well as our interactions with the agency, we believe and they have a—
provided reassurance in writing that the design of the Envision trial would support approval of UGN-102 and that the decision will be based upon the totality of the data we present to them.
Yeah, I think the other thing I'll add is two things about SPA. I mean, the agency doesn't do SPA very often any longer, and so we would have had to have done that before. So, we don't have a special protocol assessment with the FDA, but we do have our minutes from our meeting that says that a single-arm study can be the basis.
And as Mark mentioned, what they say is it's got to be clinically meaningful, and it's based on the totality of the data, which is not different than what they would expect to say, that we would expect them to say. But the good news is that what we have to, everybody has to keep in mind here is there is not another therapy to compare UGN-102 to.
The only other treatment is surgery. And there has never been in any, across any therapeutic area, a study that had to be done to get a therapeutic approved, where they had to demonstrate how it did versus surgery. It was always looked at as an option to surgery.
And so that was part of the argument that we had with the FDA and the discussions around it. And they agreed. And so, you know, add that to the complexity of trying to make a comparison to a surgery. And that's why, you know, ultimately the FDA agreed. They just weren't comfortable. Frankly, we asked for approval on our phase two study. They just weren't comfortable with sixty.
no further questions. I would now like to turn the call back over to Liz Barrett for closing remarks.
Thank you, operator. And again, as always, we really appreciate your interest in our company. We're very excited about what's happening with John . We're very excited about the fact that this year we'll actually be able to share data on a significant number of patients for Eugene one of two. As everybody knows, and that's been a highly anticipated medicine for us.
And, you know, we appreciate everything and look forward to sort of sharing more as the year goes on. So let us know if you have any additional questions. Always happy to jump on the phone. So, operator, you can now disconnect. Thanks everyone. This concludes today's conference call. Thank you for participating. You may now disconnect.
I have.
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Good day, and thank you for standing by, and welcome to the EuroGen Pharma Q4 2022 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star one one on your telephone.
You will then hear an automated message advising your hand has been raised. To withdraw your question, please press star 11 again. 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.
Thank you, operator. Good morning, everyone, and welcome to EuroGen Pharma's fourth quarter and year-end 2022 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and preliminary financial results for the quarter ended December 31, 2022. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Thank you. Thank you very much for joining us today.
Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, Jeff Bova, Chief Commercial Officer, and Don Kim, Chief Financial Officer. And I'm Mark Schoenberg, Chief Medical Officer, and Don Kim, Chief Medical 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, anticipated seasonality for gelmido in 2023, our ongoing and planned clinical files, AoF- Democrat N
Commercial and clinical milestones in the year ahead, the potential of UGN-102 to transform the treatment paradigm as the first non-surgical treatment for low-grade, intermediate-risk, non-muscle invasive bladder cancer, market opportunities, potential future commercialization activities for UGN-102, if approved,
data presentations, regulatory filings, future research and development efforts, our corporate goals, our optimism regarding multiple avenues available to us to further strengthen our balance sheet, and 2023 financial guidance among other things.
These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. We are cautioned not to place undue reliance on these forward-looking statements and your agenda's claims and the obligation to update these statements. I will now turn the call over to Liz. Liz? Thank you, Vincent, and thank you, everyone, for joining us today.
Looking back on 2022, I'm proud of our progress and more enthusiastic than ever about the future of eurigen. We return to growth in Q4, delivering our strongest quarter ever for gelmito, ending the year with $64.4 million in net product revenues, representing a 34% increase from full year 2021. This bodes well for UGM 102 as we continue to think of gelmito as proof of concept surpriseeeeeeeeeeeeeeeeeeeeeeeeeee
and the gateway for the much larger market of bladder cancer. That belief is substantiated by the incredible momentum we experienced in our UGN-102 clinical trial. In just 20 months, we've enrolled over 500 patients between both the ATLAS and the Envision Phase III trial. In fact, we completed enrollment of Envision, our pivotal study for UGN-102, for the treatment of low-grade, intermediate-risk non-musclimb-based bladder cancer in less than a year. We firmly believe that this has the potential to transform the way urologists treat patients.
and based on how quickly we enrolled the trial, that we have a base of urologists who are eager to elevate their practice.
We are planning to provide top-line data from both of our Phase III studies of UGM-102 mid-year. We will provide an update on complete response and durability in Atlas while also providing the primary endpoint of complete response rate in the Envision study. Assuming positive results, these studies will form the basis of our FDA submission in 2024.
once durability has matured. UGM-102 is designed to address a much larger patient population, and administration is much simpler without the need for fluoroscopy. Therefore, if approved, we anticipate UGM-102 will prove to be our main growth driver in the future. At the end of last year, we shared long-term follow-up data from the Jomito Olympus Pivotal trial.
and the Phase IIB Optima II study of UGM-102. In each of these, we observe a greater than two-year median duration of response. Along with the recently completed small home installation study, we are optimistic about the upcoming data from Atlas and Vision will further establish the potentially transformative nature of our products. Before turning the call over to my colleagues, I would like to quickly address our balance sheet.
We've now come to better understand the adoption curve of Jomito and expect revenue growth in 2023 to reflect growth of 20 to 30 percent over 2022 and revenues of $76 to $66 million.
While we ended the year strong with $100 million in cash, we continued to reduce cash spend and focus on our core assets. Especially given the market potential for UGM 102, we are optimistic that we will be in a position to explore multiple avenues to further strengthen our balance sheet when necessary. We will continue to explore multiple avenues to further strengthen our balance sheet when necessary.
Overall, I am very enthusiastic about the progress we've made in 2022 and the road ahead as we plan for an FDA submission of UGN 102 in 2024. We believe JALMIDO and UGN 102 together represent a billion dollar revenue opportunity for eurigen and remain focused on solid execution to turn that belief into a reality.
With that, I'll pass the call over to Mark to further update you on our clinical development program. Mark? Thank you, Liz, and welcome, everyone. My comments will underscore Liz's remarks and reinforce our excitement as we advance our lead pipeline program, UGN 102.
and highlight recent real-world data from gelmido. As you may recall, we commenced the international multi-center registrational and vision study for UGN-102 in January of 2022. The study is intended to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
As Liz noted, we expect to report out this data by the end of this summer. The quickness with which we were able to complete this trial is a testimony to the interest from urologists for a new alternative for treating bladder cancer. Our confidence in the potential outcome of InVision stems from its similarity to the Phase II Optima II trial of UGN-102, which demonstrated a 65% CR rate and duration of response.
at 12 months of 72.5% using Kaplan-Meier analysis. UGN-102 also has key similarities with germito. Both products utilize mitomycin, allow for local delivery, and sustained exposure to mitomycin for up to six hours. And importantly, both low-grade NMIVC and low-grade UTUC share many biological and clinical similarities.
which leads to common clinical features, including the responsiveness to chemotherapy. UGN-102, however, has many important advantages over gel mito, which we believe will have a direct impact on its use. It does not require special equipment for procedures and is designed to be instilled into the bladder via urethral catheter in an outpatient setting, a common and routine procedure in most urology practices.
This advantage will be critical as low-grade intermediate risk and MIBC is 8 to 10 times more common and a condition that is routinely managed by 80 to 90% of neurologists, inferring a significantly larger addressable patient population.
We recently shared results from a small study that demonstrated the suitability of UGN-102 at home by a visiting nurse under the supervision of a treating physician.
6 of 8, or 75% of patients who received 6 weekly doses of UGN-102, achieved a complete response, defined as no detectable disease after 3 months of starting treatment.
Treatment-related adverse events were mild to moderate, and the few serious adverse events were not treatment-related. We anticipate a small subset of older patients with social challenges may benefit from being treated at home versus in clinic, and the results from this study provide us with added confidence that our novel investigational therapeutic has the potential to address genuine, unmet needs.
for low-grade bladder cancer patients. In December , we shared new and supportive long-term follow-up data from the OPTIMA 2 study of UGN 102 at the Annual Society of Urologic Oncology meeting. The study showed a greater than 24-month median duration of response.
with UGN-102 in 15 of 25 evaluable patients. Long-term follow-up data from gelmito's pivotal trial were also presented at SUO. The study showed a greater than 28-month median duration of response in 16 of 23 evaluable patients. Together, these studies added to the growing body of evidence.
supporting the potential for long-term recurrence-free survival associated with RT-gel delivery of mitomycin to the bladder and urinary tract to treat low-grade urethral cancer. 2023 is shaping up to be an important year for UGN 102 with multiple near-term catalysts, including POPLINE data from the ATLAS trial, the precursor to InVision, which enrolled 282 patients.
who completed treatment with either UGN-102 or primary TURBT, top-line results from the Phase III Envisioned Trial mid-year, and assuming positive results from the Phase III trial, preparing for an NDA submission with the FDA in 2024. The goal would be to target priority review, which it granted.
may potentially result in approval at the end of 2024 or early 2025. If approved, UGN-102 will be the only primary non-surgical therapy addressing the nearly 80,000 new patients in the U.S. alone who will undergo repetitive endoscopic resection and are burdened with the risks of surgery and anesthesia as their only recourse for disease control. As a practicing neurologist who cares for bladder cancer patients, this would be a transformative therapeutic advance that I believe will be welcomed by my colleagues and patients alike.
Meanwhile, our phase one trial with UGN 301, our in-licensed anti-CTLA-4 antibody for intervesicle administration using RT-GEL technology continues to enroll. UGN 301 is in development for use in combination with other immunomodulators, including UGN 201, our proprietary PLR7 agonist.
and other potential chemotherapy and immunotherapies to treat high-grade non-muscle nasal bladder cancer. This study is aimed at identifying the suitable dose for a subsequent Phase II trial. The first arm of this study, evaluating dose ranges of UGM-301 as monotherapy, is expected to be completed in the second half of 2023.
We view UGM-301 as a cornerstone checkpoint inhibitor for a variety of potential combination therapies targeting high-grade NMIPC.
In closing, 2023 will be an important year as we look to build upon the foundation of real-world evidence and clinical data supporting our increasingly compelling and well-established technology and product portfolio of innovative non-surgical therapies for urethral cancer.
And with that, I'll hand the call over to Jeff to provide a commercial update. Jeff? Thank you, Mark. Q4 represented our strongest quarter performance ever for GelMito. I'd like to take a moment to highlight a few of the underlying factors which contributed to our performance in the fourth quarter. And metrics continue to demonstrate encouraging trends in new and repeat accounts.
indicating clinical conviction from gel-mito adopters and growth in new users. Activated sites on March 1, 2023 were 983, compared to 930 on November 1 of last year. And repeat accounts were 214, compared to 177 for the same period. This is a 21% increase over the last period. Reimbursement remains at approximately 99% across all coverage types. In Q4, we saw strengthening of the gel-mito ramp and an increase in up to
Our performance in Q4 also reflects operational efficiencies from the September 2022 label update, which extended the stability period of gel-mito admixture from 8 to 96 hours. We've seen an immediate positive impact to several logistical challenges.
including allowing for delivery of the admixture the day before installation, enabling HCP preferred early morning installation.
This has led to a shift of approximately 50% of doses to day prior delivery, facilitating expansion of the geographical coverage of our mixing partners and optimizing our territory business manager's time in the field.
The growing body of outcomes from real-world evidence data continues to reinforce GelMito's efficacy and safety. In addition to supporting a multimodal approach of GelMito across multiple use cases, the
The recent independent multicenter retrospective analysis has answered a number of questions not addressed by Olympus, arming our commercial organization with a deeper understanding of gelmitos use across various practice patterns. Further, outcomes from this study add to the growing body of real-world data demonstrating a favorable safety profile for the
or seasonal dynamics as we get back to a new sense of normal.
Looking ahead, we expect typical payer dynamics in play in Q1 resulting from deductible resets, followed by stronger demand in the second quarter, slight delay in Q3 as we expect PEP conversions to slow in the summer months.
followed by a stronger Q4 as PEP conversions return to baseline. GelMito is undeniably gaining traction, and adoption appears to be accelerating as the product becomes increasingly proven, easier to administer, and incorporated across multiple practice patterns. This reinforces our optimism and lays the foundation for the potentially much larger opportunity with UGN102.
to discuss our financial results. Don? Do something about it, and if the the company's
Thank you Jeff and thank you to everyone for joining today's call. We finish the year with growing momentum, delivering our strongest quarter ever for Jeremiah T Health Green.
On an annualized basis, revenue from Jeremiah Tosei's growth grew 34% in 2022. For the fourth quarter of 2022, we reported Jeremiah net revenues of $18.1 million compared to $16.1 million for the same period in 2021.
On a full year basis, we delivered Jeremiah to net revenues in line with consensus estimates of $64.4 million compared to $48 million for the year 2021. Our performance reflects a strengthening ramp and growing adoption of gelmiter.
partially offset by lower stock-based compensation expenses in 2022. For the quarter of 2022, selling general and administrative expenses were $21.6 million as compared to $21.4 million for the prior year quarter. For year 2022, selling general and administrative expenses were $82.9 million as compared to $87.5 million for the full year 2021. The decrease in SJNA-related expenses of $4.6 million resulted primarily from a decrease in stock-based compensation and compensation-related costs in 2022 offset by brand marketing.
revenues to be in the range of $76 to $86 million. Full year operating expense is expected to be in the range of $135 to $145 million including non-cash share based compensation expense of $6 to $11 million subject to market conditions. We will continue to scrutinize all expenses in support of our efforts.
In addition to RTW financing expense, interest only payments on the $100 million Tomlorn facility with funds managed by pharma con advisors will be made quarterly and continue to accrue at a rate of libel plus 8.25% in 2023. We ended the year with $100 million in cash.
cash equivalents, which is expected to finance operations into the first half of 2024. To echo Liz, we are committed to diligently and proactively managing our balance sheet in support of our commercial and clinical development activities.
We will continue to watch revenues and monitor expenses closely while also routinely evaluating our cash position and capital market environment to the needs to opportunistically strengthen our balance sheet arrive. With that, I'd like to turn the call back to Li for closing remarks. Thank you, Dawn. I'd simply like to close by expressing my pride.
in our ongoing clinical trial.
Finally, I'd like to thank and reiterate our commitment to our shareholders. You see the importance of the goal that we are trying to achieve.
We look forward to keeping you all apprised as important events continue to unfold over the weeks and months ahead. I'll now turn the call over to the operator for a Q&A session. Operator?
And thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. And one moment for our first question.
And our first question comes from Leland Gerschel from Oppenheimer. Your line is now open. Hey, good morning, guys. Thanks for taking the questions and congrats on the progress. Two questions for me. First for Mark.
as we'll wait for the durability data from Envision, obviously, early next year after we get the response top line. And any reasons we should think that would differ from what we saw in Optimate 2? And then, second question for Liz. You just teeing off the comments you made about the size of the UGN 102 market opportunity providing potential opportunities to strengthen the balance sheet. Just wondering if that –
were patients with de novo disease, the remainder are those patients who had recurrent disease. In vision, all patients will have had recurrent disease. When we evaluated this question as to whether or not there was a difference between new and recurrent responses to UGM-102 in the opulent cohort, we were not able to discern a difference based on that cohort. So our expectation is
that in the Envision trial, we will see very similar results to what we reported in Optima. And, you know, to answer your question, Leland, I mean, to be honest with you, we're looking, you know, we're always opportunistically looking at everything. So whether it be BD, a strategic partnership, you know, other forms of capital. So we just want to make sure that, you know, we keep doing the diligence around our expenses, and, you know, we have further, you know, identified areas where we can really reduce expenses to make sure our cash.
keeps us through 23 and into 24, so that we're not forced to do anything. But look, it would be great to be able to do some sort of strategic partnership with a company if we thought it was the right thing, and if we thought it was really going to accelerate our growth. And so we'll continue to look at that as well as a lot of other options as well. But nothing has been decided. We haven't, we just feel like, given that the data is coming up this summer, that's probably a good time to think about doing something. So thanks for the question.
takes now and how that's differed since the original launch and how does the company intend to optimize the value of XUS? Jeff, you want to take that and then I'll take the XUS question.
Sure. So, hi, Mitchell. The main driver continues to be patient identification, getting into the offices and really sitting down and looking at various codes that help identify patients that could benefit from gelmido. The data to continue to get better, we continue to continue.
to do that. And then physicians, as you saw from the number that increased from repeat users, they also, once they get experience, they also look for other patients in the practice. We obviously have this data will be out there in the hands of the field. So prior to Q4 that we just reported, this data wasn't available. So we're certainly excited.
about the pieces of data, the long-term follow-up, the Waldo, which is the retrospective, as well as the Rose paper, which talks about additional anti-grade installations, to continue to help us with access, you know, get in. New data is always a positive. It allows access. Physicians are going to be very, and have been very interested in hearing about the new data since the real world is evidence is really how they're using gelmito.
which as you can see is oftentimes endoscopic resection, getting what they can see, understanding that there's microscopic disease that they couldn't see, and coming back with sick doses of gelmitin. And on the XUS question, I think, as we've talked about before, the challenge with XUS isn't getting an approval on the data we have today. It's really getting reimbursement. So, for a market like Europe , for us to get reimbursement at a decent rate that's viable for us.
actually have had a lot of success with a few patients, you know, that have had good results after using it through the name patient program. Because one piece of actually getting government to pay is when physicians start asking for it. So with a name patient program, and them getting some experience with that and, you know, their ability to be able to get access to it.
So, right now we're really focused on the US and making sure we're bringing you 102, but we know what it would take to do something, and it would require another study outside the US. Okay. And then, yeah, and on 102, just wanted to ask if the commercial strategy will require any additional infrastructure in the US. Yeah, Jeff, do you want to just talk about sort of our thoughts around that? Sure. Well, because there's a 95% overlap in key targets, it will not require a significant resource expansion. We'll always take a look at larger geographic...
Thanks for taking our questions. So the first question is, what could drive further adoption of Gemalto in 2023 and maybe potentially reach the higher end of your guidance? And maybe another question is, in 2023, do you anticipate to report additional real world data including 5 mall Baby
maybe the physician's feedback based on the stability change in the label in this year. Thanks. VA Prayer for Mass degraing in humans
physician's feedback based on the stability change in the label in this year. Thanks. Jeff?
Sure, I think the three pieces of data, actually four, are going to drive greater adoption in 2023. I'll start with the operational data that we have that the FDA approved an 8 to 96 hour stability period. That's already resulted in 50% of doses being delivered a day prior.
So, we've been able to reengage physicians that may have been a little reluctant to adopt gelmito because of the eight-hour restriction. The second is certainly the question on long-term follow-up. How long do patients stay disease-free? And we've been able to, from the Olympus data, follow a number of those patients.
where we see the median at 29 months. That's, although the number is, you know, follow up is a little bit smaller, that's very significant when physicians question or wonder, you know, well, you know, Olympus gave us 12 months upon approval, but now we see long-term follow up with the median of 29 months. I think more importantly, the two pieces, the real world evidence, talks about how physicians really practice. And,
That's going to be key and to go in and be a partner with multimodal, what we use, we use the term multimodal, be a partner with endoscopic resection. And so for those physicians that may have only been resecting and holding off on using gelmido, you'll be able to go in and talk about the difference in CR. When I say that you, the representatives will be able to again talk about the difference in CR, the increase in CR. And then finally, the Dr. Rose paper with 32 patients showing only a 9% stenosis rate with antigrade administration versus the 44% that we saw.
They don't have to worry about that. And so that's actually very helpful so they can spend their time actually out generating more patients and generating demand versus really babysitting the dose to make sure it gets to the doctor's office. But thanks for the question.
Thank you. And thank you. We'll give him one moment for our next question.
And our next question comes from Boris Beaker from TD Cowan. Your line is now open. Great, thanks. This is Nick on for Boris. I just have a quick question or quick two questions on the Atlas trial. Will you be releasing the TURBT patient data from Atlas? I know that you're planning to release about two and a half minutes.
Any commentary? Sure. Thanks for the question.
The answer is that we will be releasing the data from the TUR arm as well. I would caution everybody to remember that because the study is underpowered, we will not be able to compare the arms. However, it will give us a sense in this cohort of the performance of surgery and probably as or more importantly, safety issues around surgery in this population, which is an area of some.
interest and study in our community right now. And then secondarily, in the 102 arm, we, I think we have said on multiple occasions, we will be providing a complete response and durability data as well as safety data for that group of patients. And with caveat again, about not being able to compare arms, we do believe that given the substantial comparability of this population to the optimal population reported in our phase two experience.
we believe that it will be supportive and directionally in line with what we've previously reported and what we would expect to see in the Envision cohort as well. Yeah, so I'll just add two caveats, right? Our Optima 2 study was only 65 patients. Typically, if you look at clinical studies, and, look, I haven't seen the data, so I have no idea, you typically see somewhat of a decline in efficacy because you have a much bigger patient population. So we'll see. But we believe, to Mark's point, that it will be, you know, that will definitely be aligned in that case.
The other thing is I just also want to caution everybody on the data that we will share, because we will share top-line data, but we will not share all of the data, mainly just because we want to get a publication, you know, a peer review in a peer-reviewed journal, and we want to present it at a meeting, and you know that, you know, if we give all of the data, then that won't happen. So…
You know, we will give top-line data. We won't go into all of the details, but we will get that out, you know, in a paper and a presentation as quickly as possible. So, thank you for the question. Yeah, thank you very much. Just on UGN 102, the at-home administration, do you plan to run an additional trial for this, or, like, is this more so going to be just for physicians to see and potentially then use if they need to? Yeah, we're not planning to run another study. I think from our perspective, there were a couple things, right? We were in the middle of COVID when we, and actually, it was our chairman, Ari.
you know, investigator-initiated study, you know, bigger studies, but the likelihood of us doing a large study to go after an approval, I would say probably not very likely, but I think the data will allow. I mean, there's not going to be anything in our label that wouldn't allow for, you know, home delivery through a nurse, a home health nurse.
just like they get other things through home health today. So, I'm not sure that we need a study to be able to do that. Great. Thank you very much. Thank you. And thank you.
other things through home health today. So I'm not sure that we need a study to be able to do that. Great, thank you very much. Thank you. And thank you. And one moment for our next question.
And our next question comes from Matt Kaplan from Lattenberg, Thalman. Your line is now open. Hi, good morning, and thanks for taking the questions. Just to, I want to dig in a little bit more to Joe Mito and your revenue guidance, and specifically, potentially returning to more accelerated growth of Joe Mito. Can you talk a little bit about the...
the current use and adoption of the morphosmative in terms of administration of the morphosmative and what are your thoughts going forward in terms of that helping to drive growth further.
Jeff? Sure. Hey, Ananya, thank you for the question. It continues to go up. You listen every quarter. It goes up a certain percentage, 5 or 10%. I think with the Dr. Rose paper, you're going to see a bump in physicians that maybe have been a little reluctant.
If they just really wanted more data, now 32 patients, you have a very similar, if not better, CR, and then you have, most importantly, is a reduction in stenosis. I don't ever, I can say for a fact, it will never be, you know, 100% of the installations. Sometimes patients don't really want the catheter in their back for six weeks. So they're always going to be, you know,
first attempt at anti-grade leads to future attempts at anti-grade. So as they identify patients, they no longer give it in a retrograde fashion. They've moved their administration to strictly anti-grade. And then a follow-up with respect to the impact on the stability period. When do you think you'll, obviously it's early and the label changed, but when do you think you'll see kind of a
the full impact on improving adoption and driving costs. I think Q2, we've already seen it go from 20% to 50% in a short period of time of day before installations. I think you're gonna see that continue to increase. Look, some physicians still don't need it the day before, just depending on when they wanna do the procedure. But I think what it does is if 50% or the day before, it's freeing up, as Liz alluded to earlier.
that time of the representative. And so you'll start to see more demand-driven activities from the representative versus really ensuring that operationally the dose arrives. So as our independent pharmacies and our partner pharmacies, the mixer that we currently use, adopt and get used to mixing later in the day and delivering it later, that'll continue to become more efficient. And we'll follow the guidance of the practice, if they were required the day before.
And I think what we continue to see is slow, steady growth. So unlike, you know, will there be a time where you'll see a hockey stick inflection point? We don't think so. We think that it will continue to grow. We're seeing that. We're seeing more stability, more consistency, and you'll continue to see that. And I think that is reflected in our guidance for the year. But, you know, we're happy about that. It's good to see that consistent growth.
And, but I don't, we don't think they given even given the great data that we have, we think we'll continue to get more and more positions. And we've been adding positions every quarter. We add positions, new positions, and it does get back to what Jeff said earlier around finding the patients. You know, again, there's six to seven thousand of these patients being treated. By ten thousand physicians, so it's always a matter of being in the doctor's office at the time that they identify that patient. But thanks for your question. I hope that helps. No, that's helpful. And then just a question on one or two, given the expectation for top line data this year.
Can you elaborate more on the regulatory timeline for the product and the rate-limiting step, whether it's DMC or long-term follow-up? What's the rate-limiting step for filing for the NFT? Yeah, it really is durability, you know, waiting for durability.
Remember, we look at CR after three months from the time they started therapy, and then we need all of those patients to have a minimum of 12 months. The good news is obviously some of them will have more than that. And that was the strategy we used with Gelmito is we didn't wait for everybody to have long term follow up, but we were able to go in there with the majority of them. For 102, we'll wait for everybody to have 12 months.
post their CR, and that will give us some strong data in which to go forward to the FDA. So that's really what's driving the timing. CMC, knock on wood, in this case, because it is so similar to Delmito, we don't really foresee any issues there. We think that will go very smoothly. And so it really is just a matter of the clinical data and getting the database cleaned once we get the durability.
and having that data to go forward. So we haven't given a time exactly of when we're going to file. And, you know, it is also an event-driven study, right? So in addition, we have to know we have a certain number of events as well. And so that's what will drive it. So we're comfortable saying 2024, and we're comfortable saying that, you know, if given priority review, you know, we could potentially get at the end of 24 or, you know, beginning of 25.
So, durability data for SAVA 24, is that the expectation? Well, yes, exactly, absolutely. Thank you. And then last question in terms of 301, what will you be looking for on the data of 301 that will put SAVA over the SAVA?
Yeah, Mark, you want to talk about 301? Yeah, sure. Thanks, man. So what we're currently doing is those escalating 301 and that obviously is predominantly a safety experience. For the appropriate dose.
So the initial finding is going to be the appropriate dose. Subsequently, our plan, as I think you know and others do, is to combine this with other immunomodulators and chemotherapeutics. So ultimately, though those data will not be forthcoming this year, hopefully in the near term we'll be able to share combination data that would provide evidence of efficacy in this.
high-grade population, which is obviously different than the gel mito and UGN-102 populations we've been focusing on. But for right now, what we're focusing on is finding the appropriate dose and demonstrating safety. Thanks a lot, guys.
which is obviously different than the gel mito and UGN-102 populations we've been focusing on. But for right now what we're focusing on is finding the appropriate dose and demonstrating safety. Alright, thanks a lot guys. And thank you.
And thank you. And one moment for our next question. And our next question comes from AJ Velasquez, male from Jefferies. Your line is now open. Hi, all. This is AJ for Chris Harrison. Just one additional question here. For the Envision trial, what gives you confidence that a single-arm design is sufficient for approval? And would you consider, or could you get like a SPA agreement with the FDA?
So, Mark, do you want to talk about the feedback we got from the FDA? And I can also add any color. Yeah, thanks.
Thank you. The the confidence has to do with our interactions with the FDA in presenting our phase 2 data and long conversations with them about the role we believe UGN 102 can play in neurologic practice. So on the strength of the phase 2 data as well as our interactions with the agency we believe and they have
provided reassurance in writing that the design of the envisioned trial would support approval of UGN-102 and that the decision will be based upon the totality of the data we present to them. Yeah, I think the other thing I'll add is two things about SPA. I mean, the agency doesn't do SPA very often any longer, and so we would have had to have done that before, so we don't have a special protocol assessment with the FDA.
But we do have our minutes from our meeting that says that a single-arm study can be the basis for an approval. And they've made it very clear, and we've shared this before, that we'll go to an ODAC. And frankly, we're very happy to go to an ODAC. We believe we'll win in an ODAC. We know that physicians want access to this medicine. And so we're very comfortable and confident with that. And as Mark mentioned, what they say is it's got to be clinically meaningful, and it's based on the totality of the data, which is not different than what they would.
that had to be done to get a therapeutic approved, where they had to demonstrate how it did versus surgery. It was always looked at as an option to surgery. And so that was part of the argument we had with the FDA and the discussions around it. And they agreed. And so add that to the complexity of trying to make a comparison.
you know, to a surgery, and that's why, you know, ultimately the FDA agreed. They just weren't comfortable, frankly. We asked for approval on our phase two study. They just weren't comfortable with 65 patients. So they're like, we need a much larger patient population, and we agreed with them on the 220 patients. So I hope that helps. Very helpful. Thank you. Very helpful. Thank you. And thank you. 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. Thank you, operator. And again, as always, we really appreciate your interest in our company. We're very excited about what's happening with JALMIDA. We're very excited about the fact that this year we'll actually be able to share data on a significant number of patients for UGN-102, as everybody knows. And that's been a highly anticipated medicine for us.
And, you know, we appreciate everything and look forward to sort of sharing more as the year goes on. So let us know if you have any additional questions. Always happy to jump on the phone. So operator, you can now disconnect. Thanks, everyone. This concludes today's conference call. Thank you for participating. You may now disconnect.