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spk01: Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the EuroGen Pharma's first quarter 2021 financial results and business update conference call. It is now my pleasure to turn the call over to Lee Roth of Burns McClellan. Please go ahead. Thank you, operator.
spk07: Good morning, everyone, and welcome to EuroGen Pharma's first quarter 2021 financial results and business update conference call. I'm filling in for Sarah Sherman, head of investor relations at EuroGen, who is on maternity leave. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended March 31st, 2021. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Jeff Bova, Chief Commercial Officer, Dr. Mark Schoenberg, Chief Medical Officer, and Molly Henderson, Chief Financial Officer. Please note that we continue to conduct our calls from different locations, so we appreciate your understanding should we have any technical difficulties. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing commercialization of Gelmido, planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, and 2021 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, as well as the latest SEC disclosure documents. Your cautions not to place undue reliance on these forward-looking statements, and your urgent disclaims any obligation to update these statements. With that, it's my pleasure to turn the call over to Liz.
spk13: Thank you, Lee, and thank you to everyone joining us today. While it has only been eight weeks since we hosted our fourth quarter and full year 2020 earnings call, we have continued to make important progress towards our goal of becoming the leading uro-oncology company. Our ongoing priority is the successful commercialization of Jalmito. Despite facing the unique challenge of launching during a global pandemic, Jalmito's place in the clinic continues to take shape as the only FDA-approved non-surgical treatment for adult patients with low-grade upper tract ulcerative cancer. For the first quarter of 2021, we recorded $7.5 million in net product sales. This brings us to a total of $19.3 million in sales since the June 1, 2020 launch of Jelmido. As mentioned during our year-end earnings call in March, we experienced softness in the beginning of the quarter, which we attribute to the start of the vaccination efforts throughout the United States. And patients, specifically within the age group that are most likely to suffer from UTUC, were delaying treatment appointments until they were vaccinated and felt comfortable going to a healthcare facility. As you have undoubtedly heard as numerous companies report earnings, this impact was seen across the biotech, pharma, and medical device industries. Jeff will provide more detail in a bit, but we are confident in our outlook for Gemido for the remainder of 2021 and beyond. due to the increase in patients treated in March and April and the record number of patient enrollments we received over this same period. We believe the increased demand is driven by the fact that a large percentage of our patient demographic has been vaccinated and COVID-related restrictions are relaxing in many parts of the country. While we have not provided specific financial guidance, we reiterate our position that our internal projection for 2021 is aligned with the analyst revenue consensus. We also want to share that our preliminary results for April represent the highest monthly revenue since launch, making us optimistic about Q2 and the remainder of 2021. Beyond Gemido, we are making progress with our UGN 102 program, and specifically the Phase III Atlas trial, which kicked off in late 2020. We are recruiting and enrolling patients in the U.S., Israel, and Europe, and expect to provide an enrollment update later this year. We are excited about the potential of UGM-102 has to transform the treatment landscape for patients diagnosed with low-grade intermediate risk non-muscular invasive bladder cancer, if approved. There are significant similarities between the therapeutic indications for Gemido and UGM-102, and we expect that we'll be able to successfully leverage our learnings and experience from Gemido as we move the UGN-102 program forward. Another important priority for us is to advance our earlier pipeline and build urogen into a leader in imnio-oncology. Our most advanced IO program is UGN-302, which we are studying as part of a research collaboration with the MD Anderson Cancer Center in high-grade non-muscle-invasive bladder cancer. We have also begun work with the Johns Hopkins University to study in a preclinical setting the potential of checkpoint inhibitors combined with RT gel and glioblastoma multiforme, or GBM, an aggressive form of brain cancer. Mark will provide additional commentary on both of these programs. I'm proud of our continued strong execution during a global pandemic and the significant progress we're making against our strategy. We believe that very few companies are in the unique position we at Urogen enjoy. We have an approved product that alone could be a standalone profitable business, and our second therapy is in a phase three clinical trial and is de-risked given the similarities with gel mito and impressive phase two results. We also have a unique medicine in preclinical that, if successful, has the potential to change the treatment paradigm in high-grade non-muscle-invasive bladder cancer. These three therapies combined reflect what we consider one of the strongest pipelines in uro-oncology and can provide a long-term growth business and a portfolio that can support a sustainable business for many years to come. We will continue to build our presence in urology and oncology and leverage our proprietary technology through partners in other areas that could benefit from a sustained release delivery mechanism. Before I turn things over to Jeff for additional detail on our commercialization efforts, I want to recognize and thank our employees for their hard work and resilience during this challenging time. About three quarters of our employees have been with URGEN for less than two years. This means the majority of their tenure has been significantly impacted by COVID-19. But through it all, they have remained focused and committed to our mission of helping improve outcomes for patients battling urologic malignancies. I could not be prouder to lead this team or more excited about the future of our company. I'd now like to turn the call over to Jeff. Jeff?
spk06: Thank you, Liz. I'm pleased to provide you with an update on our commercial launch of Gelmito. As Liz mentioned, we reported 7.5 million in net product sales in the first quarter of 2021, which totals to 19.3 million from the start of Gelmito's launch on June 1st, 2020. Please keep in mind, as we discussed in March, that about 500 to 800,000 of sales in Q4 were stock-ups that were worked through in the January, February timeframe. When you take this into account, Q1 surpassed Q4 in terms of patient demand. As noted earlier, the COVID-19 pandemic has presented challenges to our industry. At the beginning of the year, COVID infections and hospitalizations spiked across the country. Vaccinations were still in the very early stages of rollout, and this created a situation where we believe that patients postponed doctor and treatment appointments. This was happening across our industry, as evidenced by a recent Kaiser Family Foundation study that reported 25% of Americans said that they or someone in their household had delayed medical care in December due to coronavirus concerns. Another report from the U.S. Centers for Disease Control and Prevention found that 41% of Americans delayed medical care, including 12% who postponed urgent or emergency care. And lastly, in January, elective procedures were down 25%, according to IQVIA data. We believe the impact of patients postponing treatments until they are vaccinated is generally behind us, given that the vast majority of people in the U.S. over the age of 65, which is our patient demographic, are now vaccinated. In fact, as of today, 83% of the U.S. population over the age of 65 have received at least one dose of a COVID vaccine, and close to 70% have been fully vaccinated. With market conditions improving, we are seeing a rebound in gel mito sales in the second quarter and expect this to continue for the rest of the year. As Liz mentioned, we have already seen a steady increase in patient activity. In fact, in March and April, we set new records in terms of patient enrollment forms received. The total number of patient enrollment forms received in March and April was more than four times the number we received in January. And as a reminder, patient enrollment forms are the initial step to getting a patient treated and our best leading indicator of future patient starts. To minimize the time between receiving an enrollment form and treating the patient, we have been diligently working to activate sites since our launch last year. I'm proud to report that as of May 1st, we have increased the activated sites to 316, up from 250 just eight weeks ago, and up from 210 at the end of 2020. These are sites who have either treated patients or have completed all of the internal processes required to allow them to treat patients. The other indicator we routinely monitor is the number of repeat accounts, meaning accounts that have treated more than one patient. We believe this suggests that physicians are potentially seeing clinical efficacy of the therapy, that reimbursement is working, and all of the other components of the process have run smoothly. As of May 1st, we have increased the number of repeat accounts to 40, up from 31 accounts on March 1st and 24 accounts at the end of 2020. This is a critical success factor showing us that the processes and support in place are working, and clinicians are identifying additional patients and gaining comfort in using this treatment. Access to physicians has also started to increase across the country. Our team did a great job since launch in June, engaging with doctors virtually. But there is really no substitute for face-to-face interaction. I have been out with members of our field team recently, and I can tell you that they are excited. and are looking at this as the in-person phase of our launch. To me, we are finally in a fair fight, and our team is taking full advantage. To underscore this point even further, field-related travel and entertainment expenses were up 15-fold from January to February, and we saw another four-fold jump from February to March. Our ability to have meetings in offices and conduct live speaker programs played an important role in our strong finish to the first quarter and the great start we had to Q2. Before I turn things over to Mark for a clinical update, I want to share results from the most recent awareness, trial, and usage research we conducted. These studies track physicians' awareness of the product and their experience using the product. The data for gel mito is extremely positive. The following trends were noted. Aided and unaided awareness of gel mito have continued to increase, and are now 94% and 68% respectively. These percentages are almost unprecedented in our industry, especially this early into a launch. The second point I want to share is that urologists who have used gel mito report 88% overall satisfaction, which is an average of how they rated patient acceptance, ease of administration, logistics, safety, and efficacy. And lastly, and most importantly, 83% of the urologists in the survey suggest they would use Jelmido within the next 12 months. The leading indicators and feedback we are getting from physicians are all very positive, and we remain highly optimistic that the increased activity we've experienced in March and April will continue and that we will deliver on our full year 2021 revenue expectations. With that, I'll turn the call over to Mark.
spk09: Mark? Thank you, Jeff. Since our last quarterly call, we've continued to make progress on our UGN 102 program for patients with low-grade, intermediate-risk, non-muscle-invasive bladder cancer. We are enrolling patients in our Phase III ATLAS trial with about a third of the trial sites in the U.S., a handful in Israel, and the remainder in Europe, primarily Eastern Europe. We look forward to providing you enrollment updates for ATLAS in the second half of this year as we work to bring this investigational treatment to patients. In addition to ATLAS, we are planning to initiate a small, single-arm, at-home installation study of 102 with a goal of demonstrating that at-home installation is a feasible method of administration and further reinforcing its potential differentiation from TURBT. We plan to enroll approximately 10 patients who would receive UGN 102 administered by a qualified home health provider. This study is expected to initiate in the second half of 2021. As you know, our goal with UGN 102 program is to demonstrate that a non-surgical therapeutic alternative can function as primary therapy for low-grade intermediate risk non-muscle invasive bladder cancer patients. Importantly, a non-surgical option would help patients avoid the risk of potential complications that come from the current treatment approach, which is repeated TURBT procedures. Dr. Gary Steinberg and I recently had a manuscript published in the Journal of Urology, which highlighted the challenges associated with repeated TURBT, including the high rate of disease recurrence, as well as the risks and complications of the procedure. The manuscript, which is currently available online and will be in the July print edition of the journal, addresses the desire of both patients and physicians to identify non-surgical alternatives to TURBT for recurrent NMIBC. We also recently received notification that the AUA accepted multiple abstracts we submitted for the presentation at the annual national meeting in September. We have been conducting extensive research aimed at better understanding the unmet need and clinical course of patients living with intermediate-risk NMIBC. This work, which is performed in partnership with groups at both UCLA and the University of North Carolina, explores multiple aspects of the disease course and the contemporary patient experience. Turning to gel mito, we are launching a registry program that will enable us to collect information about this drug's use in practice and gain a real-world evidence-based look at how physicians are treating patients across the U.S. We believe this information will be invaluable as we look to optimize treatment with gel mito. One of the things the registry program will help us better understand is the prevalence of nephrostomy tube administration and what impact this has on the patient experience and clinical outcomes. While none of the patients in our Olympus trial were treated via nephrostomy tube, It is a part of our label, and we know doctors are treating patients this way in clinical practice. It's too early to talk numbers or outcomes, but treatment via nephrostomy tube seems to be gaining momentum, and it is intriguing to hypothesize that nephrostomy tube administration could be easier for the patient and physician practice, and may also mitigate some of the adverse events observed with ureteral catheter administration. More to come on this topic in the future. Next, I want to talk about our earlier pipeline. As Liz mentioned, we continue to expand our immuno-oncology pipeline and advance programs for high-grade disease. Our UGN302 program, a combination of UGN201, our TLR78 agonist, and UGN301, or Xalafrilumab, an anti-CTLA-4 antibody that we have combined with our RT-gel technology, is initially being developed for patients with high-grade non-muscle invasive bladder cancer. We've often discussed that there are significant differences between high-grade and low-grade disease. High-grade non-muscle invasive bladder cancer is an aggressive and potentially life-threatening malignancy characterized by both significant risk of recurrence and rapid disease progression. Some patients with high-grade non-muscle invasive bladder cancer respond to immunotherapy using Bacillus Calmectoran, or BCG, which explains the strong rationale for exploring immunotherapies for the treatment of this patient population. Our 302 program has demonstrated encouraging non-clinical data to date, which support the potential of locally applied combinatorial immunotherapy. Our collaboration with MD Anderson for this program allows us to leverage their expertise in innovative clinical trials, and we look forward to providing updates as we work on next steps and trial designs. We also recently announced a sponsored research agreement with Johns Hopkins University in which we intend to explore, in a preclinical setting, the potential of checkpoint inhibitors combined with RT-GL in chleoblastoma multiforme, or GBM. The origin of this program was our focus on expanding our novel RT-GL technology in combination with other medicines to investigate potential treatment options for patients in diseases with significant unmet need and where local immune modulation may make a difference. GBM, the initial area of focus for this agreement, is an aggressive malignant brain tumor with a five-year survival rate of less than 5%. This is a difficult-to-treat disease with limited available treatment options, most of which include surgery followed by radiation and chemotherapy. It is the most common primary brain tumor with around 12,000 cases diagnosed each year in the U.S. We look forward to examining the combination of our RT-gel technology in immuno-oncology and continuing to pursue potential collaborations with academic centers who may leverage our technology in exploring therapeutic options. And with that, I'd like to turn the call over to Mollie for a financial overview. Mollie?
spk11: Thank you, Mark, and thank you to everyone who joined today's call. As mentioned, we recorded net product sales of Jomaido for the first quarter and in March 31st, 2021, of approximately 7.5 million. Although this was a slower start to 2021 than we had initially anticipated, we are optimistic with respect to revenues for the remainder of the year. As Jeff mentioned, we have set new records in patient enrollment forms in March and April. And April was our strongest month yet in terms of both new patient starts and shipments. Cost of revenues for the first quarter of 2021 were approximately $0.9 million, resulting in a gross margin of 88%. In periods prior to receiving FDA approval of Gemido, we recognized inventory and related costs associated with the manufacture of Gemido as research and development expenses. We expect this to continue to impact cost of revenues through the second quarter of 2022 as we produce Gemido at costs reflecting the full cost of manufacturing and as we deplete inventories that we had expensed prior to receiving FDA approval. Gross margin would have been approximately 85.6% versus the 88% for the three months ended March 31st, 2021, if we had not sold Jalmatu units that were expensed prior to regulatory approval. Research and development expenses for the first quarter ended March 31st, 2021, were 10.5 million compared to 16.6 million for the same period in 2020. R&D expenses declined 6.1 million in the first quarter of 2021, compared to the first quarter of 2020 due to a one-time payment of $6.6 million to the Israel Innovation Authority to unwind our obligation regarding grants that were loaned to the company between January 2004 and September 2016. Other than the commitment to continue at least 75% of our R&D jobs in Israel for a period of at least three years, all other obligations with the IIA have ended. Also included in research and development expense was $1.1 million in non-cash share-based compensation expense for the first quarter ended March 31, 2021 as compared to $1.9 million for the same period in 2020. Selling general administrative expenses for the first quarter ended March 31, 2021 were $22.2 million as compared to $22 million for the same period in 2020. The increase in selling general administrative expenses resulted primarily from an increased cost and activities related to the commercial launch of Gemido. Selling general administrative expenses included $5.1 million of non-cash share-based compensation expense for the first quarter ended March 31, 2021, as compared to $5.7 million for the same period in 2020. For the first quarter ended March 31, 2021, we reported the loss of $25.9 million, or $1.17 per share, This compares to a net loss of approximately $37.8 million, or $1.79 per share, for the same period in 2020. The net loss for the first quarter ended March 31, 2021, includes $6.2 million in non-cash share-based compensation expense. In light of the impact of the COVID-19 pandemic has had on our revenues in the early months of 2021, we continue to monitor our expenditures to ensure that we are spending wisely and investing in areas of business that will yield a strong return on investment. As a result, we are narrowing our guidance for 2021 operating expenses to $155 to $165 million, which is the lower end of the range previously announced of $155 to $170 million. Additionally, in accordance with U.S. generally accepted accounting principles, the company anticipates accruing approximately $12 to $15 million in non-operating finance expense relating to the RTW transaction announced in March. of which cash payments for 2021 will equal 9.5% of Jomaito sales. The financing charge will be reported below the operating income and loss line. Lastly, we closed the first quarter with approximately $75.9 million in cash, cash equivalents, and marketable securities with no debt. This was supplemented following the end of the first quarter by the $75 million in funding we announced last month from RTW, which was received in the second quarter following receipt of necessary regulatory approvals. We anticipate that our current cash balance supports the company's initiative into 2023 and believe we are in a solid financial position to execute on our strategy. With that, operator, I would like to turn the call over for questions.
spk10: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Eric Joseph with JPMorgan. Your line is now open.
spk12: Good morning. Thanks for taking the question. This is Hannah on for Eric. Just a few from us. First, looking at the soft sales from the last quarter, as things start opening back up, do you anticipate that you might be seeing any patient warehousing impacts from the pandemic, and therefore any potential for a bullish effect in second quarter and third quarter that might not be reflective of the subsequent quarters?
spk13: Hi, it's Liz. Thanks for the question. I think what we have already seen and what we've talked about on this call is we've already seen an uptake. I would not call it a bolus, and I'll ask Jeff to comment as well. You know, one big bolus that you would actually see go down, but I think what we're seeing is very consistent higher patients coming in. So, Jeff, do you want to add anything to that?
spk06: Sure. So we see steady growth. So I would agree with Liz. You just don't see a significant bolus. But as offices are opening up, patients are getting vaccinated, patients are coming in to get treated, we're starting to see that steady growth. And then even the access to the representatives, you know, obviously in an orphan drug setting, patient identification is key. And our reps are the face of Gelmido. And so having them in there help identify additional patients, Again, not a bolus effect, but a steady increase in patients coming in Q2 to Q3.
spk12: Okay, thank you. And also, just looking at the breakdown between re-treatment sites versus newly treating sites, in terms of the proportion of treated patients, do you see re-treatment sites picking up in that respect? For example, treating a larger proportion of patients? compared to before, or is that breakdown in terms of percentages remaining more or less steady?
spk06: No, I see that increasing as well. You're starting to see multiple patients in one account. The other thing that we're starting to see are multiple physicians in that account. I always talk about that peer-to-peer interaction being a second wave of launch, and we're starting to see that number grow as well, and we'll continue that
spk12: And if I could, thank you so much. And if I could, just one more. So you've guided to ex-U.S. regulatory updates in the second half of 2021, but while you might not be able to provide outcomes at the moment, just wondering what regulatory agencies you've been speaking to and what those topics of conversations have been so far.
spk13: So we haven't had any regulatory outside of the U.S., obviously. I don't think we talked at all about regulatory updates. What we said was that the you know, by kind of mid-year, we would know more about what we needed to do to launch around the world. And part of that is obviously talking to regulatory agencies, but it's also, you know, understanding what clinical studies we might need to do. So there's more than just regulatory. So we're in ongoing dialogues in the U.S. on many things, right? We have our IND for our 302 program, and we're always talking to them about UGN 102. And And making sure that we're covering all our bases there from a standpoint of maybe other populations that we might be able to study. So we have an ongoing dialogue with the FDA. We do have upcoming meetings in both Europe and Japan that will give us more of an understanding of exactly what needs to, for us, exactly what we need to do to launch in those space, in those geographies. But Those, as we said, would be kind of mid-year timeframe. We'll be able to give a better idea of what's happening ex-US.
spk12: Okay, great. Thanks so much for taking the questions.
spk10: Thank you. Thank you. Our next question comes from Chris Howitton with Jefferies. Your line is now open.
spk02: Great. Well, congratulations to your team, Jeff. Really a good quarter from my perspectives and nice to see. I guess with respect to kind of the performance that we're seeing overall there, what, you know, I think you said in your prepared remarks something along the lines that one cue is outperforming patient demand. If you could just walk us through those numbers relative to what you saw in fourth quarter, I think that would be really helpful. And then the second question I have is for Mark. I guess I'm curious if you could just give us a little more color as to what the expected presentations might be at AUA. And in particular, I'm interested if you have any analysis of recurrent rates for the TURB-T procedure in the intermediate risk patient population. Thank you.
spk13: So, Jeff, why don't you take that first, and then Mark can chime in.
spk06: Sure. Thanks, Chris. So to put some light on what happened at the end of the year. So what we had were a handful of accounts that because of, I think everyone can relate to the shipping issues, the demand from Amazon and FedEx and everything else. We had a handful of accounts that ordered a bulk amount. So they ordered the six doses. They wanted to be sure that they had the accounts. We had Obviously, a lot of weather issues at FedEx Hub in Tennessee. And so the 500 to 800 would have been reflected in Q1. Therefore, Q1's demand was actually higher than Q4. So most accounts, in fact, 95%, you know, they'll order one at a time. What we saw at the end of the year because of all the issues we were having, weather-related and then package demand, accounts ordered more than one. Hopefully that helped.
spk09: Yeah. Okay. I got it. Chris, thanks for the question. And I have to apologize in advance. I can tell you generally that we've been focused, as you know, on getting a better understanding of the actual course and experience of patients with intermediate risk disease. And so a number of the abstracts will in fact, address at a granular level some of that information, which comes from a very good contemporary database. In addition, there will be some very specific information presented about patient experience and patient attitudes towards surgery. Unfortunately, I can't be more specific because the abstracts are actually embargoed, but I hope that's helpful, at least in giving you a sense of where these presentations will go directionally.
spk02: Yeah, okay. Yeah, that is helpful. And I guess, do you know Any more timelines in terms of when the abstracts or whatever would become available? I know you said the meeting is in September.
spk09: Yeah. Historically, the abstracts have become available, I believe, about three or four weeks before the meeting. But I'm sure that we'll be able to provide more updates because it's been a bit of an unusual year in terms of scheduling of the AUA and format presentations. It's a little hard to predict. But if history is any guide, it'll probably be sometime in August.
spk02: Okay, well, awesome. I very much look forward to that. Thank you. Thanks, Chris.
spk10: Thank you. Our next question comes from Ram Savaraju with HC Wainwright. Your line is now open.
spk05: Hi, thanks so much for taking my questions and congrats on all the progress. Can you hear me?
spk13: Yes, we can. Thank you.
spk05: Okay, so firstly, a question for Liz on strategy. I think you were talking earlier about regulatory interactions in ex-U.S. territories. Can you discuss a little bit the overall plan with respect to Jelmido, UGN 101's penetration into ex-U.S. territories, how you're viewing the most expeditious and optimal, effective, efficient way of doing that, whether that's going to be via partnerships or distribution arrangements, you know, how your thinking has evolved over time, you know, since the Gelmido launch in the United States?
spk13: Yeah, it's a great question. And, you know, I think we're obviously thinking about it opportunistically. I think we feel like likely we would not commercialize ourselves, you know, XUS. And, you know, we've looked at it, but we'll likely partner with, We have had a lot of interest in, like, individual regions, but so we're considering whether it makes more sense to have one or two larger partners that can cover more geography, or are we willing to sort of take, you know, more regional deals. I think at this point in time, we've decided that the freedom to operate and to maintain, you know, fewer partners, XUS is probably the better route for us, you know, because if you start to think about, you know, just the distraction and the individual countries for gelmido, again, being an orphan drug. Now, as we start to think about 102, you know, that could easily change. But at this point in time, you know, we have had interest in Europe, we've had interest in Japan, we've had interest in China, we've had interest in, you And, you know, Latin America, we've had interest in Canada. And so what we're, you know, what we have to do first is find out exactly what it's going to take because before we could do a deal with a partner, you know, we need to understand what has to get done in those regions. And, you know, as we've talked about before, you know, a small company, we haven't, we didn't have the resources to really spend there, but we are doing that now. So we have interactions upcoming, as I mentioned, both with Europe and Japan and And after that, then we'll, you know, more increase the conversations that we've been having with some of our partners after we understand that we've had a lot of interest in China, as you can imagine. And so I think the first step is for us to know exactly what the plan is and then to, you know, to discuss with potential partners what that might look like. But I think if I had my preference, I think I'd rather have fewer partners you know, with more geography. I think the one area that we may feel differently about is Israel, which is not financially doesn't matter so much, you know, isn't significant, but frankly, you know, we are an Israeli based company and we think it's important for us in the, you know, Israel physicians and institutions were part of the studies since we started. And so we are looking to try to commercialize in Israel as quickly as possible. Either ourselves, we could do it, or through a partner there. So we're working on that as we speak.
spk05: Okay, and then just a couple quick questions. I don't know whether these are more addressable by Jeff or by Mark, perhaps by both. If we could start with the at-home installation potential for UGN 102. I was just wondering if you could provide some more color on the degree to which this might be commercially impactful presentation of the drug and also the extent to which you're already seeing interest in this presentation, this context from both patients and physicians. Thank you.
spk13: Yeah, I think I'll just take that because it's just easier. The home installation is for the 102. It's not for gel mito. I think that's really important. I think there may have been some confusion around that. So what we're looking at and the purpose of doing that was a couple of fold. One is the installation for 102 is much easier than it is for gel mito, given that it's in the lower tract. And we think it's really important for patients, for physicians to understand, and for regulators to understand the ease of use of 102. So to provide the flexibility of being able to have these installations done at home, that not only broadens the patient population that may be able to get 102, But it also serves to demonstrate the ease of use of 102. So in fairness, we don't expect a large majority of the patients. It would probably be a small minority of the patients that would actually end up with using it at home. But we think it's important to do a home installation study, given what's happened this past year in the pandemic and some of the challenges we've had is to demonstrate our ability to actually have a therapy that is much easier to give than what you see with TRBT. So those are some of the reasons and rationale for us doing this study. So I hope that helps.
spk05: Yeah, that's very helpful. One last one here. With respect to the nephrostomy tube-based application, I was just wondering if you already had clarity regarding how to pursue this from a regulatory perspective, or what are the implications with regard to labeling or if you think that this is likely to be more pursued or become part of the treatment continuum with respect to the product from a commercial standpoint, purely on the basis of physician discretion, as it were.
spk13: Yeah, the good news is it's already in our label. So because it was part of this trial, even though no one used it, it's actually in our label today. So we don't need to do any additional regulatory work. We do think that it's an exciting area for us because we have found physicians are able to give it in the clinic and in their office, and so it may be an ease of use, but we don't need to do anything from a regulatory standpoint. We want to be able to share with physicians and other physicians the experience that some are having with it, which is one of the reasons we want to be able to talk about it more and to share experiences, but we don't need to do anything from a regulatory standpoint.
spk08: Thank you.
spk10: Thank you. Our next question comes from Derek Archillo with Stiefel. Your line is now open.
spk03: Hey, good morning, guys. This is Jacques on Fort Derrick. Thanks for taking our questions. Just a couple from us here. First, regarding formulary approvals, are there any upcoming ones that could be major drivers? And then if I could... fit the last one in here about how you view spending quarter over quarter and what the progression might look like there. Thanks.
spk13: So, Jeff, why don't you take the formulary question and then Molly can follow up with the quarter over quarter spending.
spk06: Sure. So, yes, Jacques, you could, every quarter, every week, we have formulary reviews. You have committees starting to meet again. if they delayed because of the vaccine or COVID. So we have a significant number still in formulary review and accounts coming on. Every one of those is a huge win because you get through that internal process, the bureaucracy of the particular account. So it then opens it up for physicians within that practice. I will say, for the most part, the major cancer institutions, if not all, have us already on formulary. But for us to be, you know, constantly working through formulary, I see that continuing and opening up accounts, and they will have significant impact the remainder of the year.
spk11: And as it relates to spending quarter of a quarter for the year, I think, you know, you saw Q1 was a little bit lower largely because of COVID, some T&E commercial spends. But we would expect that would continue to ramp for the rest of the year, especially as it relates to the ongoing 102 trial.
spk03: Great. Thanks. That's very helpful. And congrats on all the progress.
spk10: Thank you. Thank you. Our next question comes from Matt Kaplan with Ladenburg-Thalmann. Your line is now open.
spk08: Great. Thanks. Good morning, guys. Just wanted to get a little bit more color, I guess, now with 316 sites open up. Can you put that in context for us in terms of the number of sites overall that you would expect to be able to have, you know, trained and ready to use Gelmida?
spk06: Jeff? Sure. So we have, you know, we target around 1,300, 1,500 accounts, of which, you know, we quartile one or our top accounts, 500 to 600. So I'm very pleased with where we are with the major accounts that we wanted to make sure that we had access to early on. That number, as I stated, continues to grow, will continue to grow up to that, you know, 1,300 to 1,500. at peak and to have the majority or all of those accounts on board. But the 316 continues to grow in those key accounts that we're obviously targeting.
spk08: Okay, that's very helpful. Thanks, Jeff. And then I guess maybe for Mark, give us a little bit more color in terms of how the enrollment in Atlas is going. and sites opening up. You mentioned kind of expectation for one-third of the sites in the U.S. and some in Israel and another bulk of sites in Eastern Europe. Can you give us a sense in terms of where you are in opening those sites and enrollment in the study?
spk09: Matt, thank you. We actually have not released specific information either about patient numbers or site numbers, but I can tell you that we're charging along, working hard to open up the sites that we predicted we would, both in the U.S. and in Europe. And that is, in fact, happening. We've had calls as recently as yesterday with European regulators regarding the protocol. So we are moving forward and pleased with the way that is going. But unless Liz wants to comment further, I think that's probably about as much as I can say right now.
spk13: Yeah, I think, you know, the only, Mark's right. You know, it's typical. It's actually what I'm seeing here is now that we're kind of starting to open sites, it's very typical of what you would normally see in any clinical study, right? You'll, we'll get to a point where we start to see a hockey stick. We're not there yet, but we are seeing sites, you know, coming on, you know, every week. So, we'll be able to be in a better position and give more of an update later this year.
spk08: So thanks, Matt. Yeah, that's helpful. Thanks. And then our last question, I guess, more on kind of get a sense on your business development. I guess two areas in terms of questioning in terms of your RTGL technology and business development there and how you're thinking about that. And then I guess now with your commercial operations up and running fully in uro-oncology, urology, I guess what are your plans from a business development point of view to bring in potentially new products as well externally?
spk13: Yeah, it's a great question. You know, on the RT-JAL, you know, we absolutely talk to mostly academic centers, but we have had a couple of companies say, hey, there might be something, you know, interesting either for us in their portfolio or for them in their portfolio. So we are, you know, we are always looking for potential areas even outside of uro-oncology that, you know, that others are interested in. Nothing that's far enough along for us to have discussion about. We are excited about one particular area that, you know, we're working with one academic institution about and, you know, when at the appropriate time we'll be able to share that information that sort of expands the use of, you know, of our technology. As far as bringing products in, we absolutely are looking for them all the time. We want to make sure we're staying within our spaces, right, of uro-oncology and specialty oncology, you know, both with and without the gel. So, you know, we constantly are doing something. We're in the process right now of doing another screen, you know, looking. You know, they're hard to find, but we absolutely would love to leverage our Our team, our company, our infrastructure, we believe we have, you know, the right infrastructure, the right people, the right expertise to add to our portfolio. But we also are not going, we don't need it, right? So it's not a situation where we need something to come in. We would like to add more to our portfolio. As I mentioned before, you know, we right now have three, you know, three different medicines at three different stages of development. But, of course, we'd love to add more either, again, in neuro-oncology or specialty oncology. So we continue to look. and hope that, you know, we can bring something in, but we want to make sure it's something that will advance standard of care and, you know, is in the right, you know, the right space for us. But, you know, always looking. If you ever run across anything, have any suggestions, please feel free to forward them along.
spk08: Great. Thanks. Thanks for taking the questions, and, you know, congrats on the good results in the quarter.
spk10: Thanks, Matt. Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is now open.
spk14: Hi. Thank you. Good morning, and thank you for taking our questions. One commercial one, perhaps for Jeff to start, just with regard to time, getting time out to therapy. Jeff, I was wondering if you could maybe just provide a little bit of color as to how, over the course of the quarter, the time that patients start between the script and them actually getting the installation has progressed, and, you know, if Right now, the primary sort of headwind is either just COVID or payer approval and so forth. Any color there would be great. And then I had a follow-up.
spk06: Yeah, well, great question. So I'll say this. It continues to get faster. We, you know, on average, it's four to five weeks to get an account up and running. A lot depends on that account. If there's a formulary process we need to go through, it could take longer. And I will say that when I said it gets faster, once an account's up and running, that number goes down to about two weeks, sometimes even less. So once they've gotten through everything, been trained on RN, gotten through the formulary process, so accounts that are on board bring that four- to five-week average significantly down. But, yes, you know, there's still accounts that if a formulary meeting isn't for a couple months, it will take a little bit longer. But the average is coming down from a setup standpoint.
spk14: Okay, great. That's very helpful. And then I had one pipeline question for Mark just regarding any expanded or updated thoughts on the GBM program and just how you're thinking about positioning the drug there. And, you know, thoughts on an early basket trial or early trial design in terms of patient groups. Are you thinking mostly operative or perioperative population, or are you thinking perhaps about, you know, in combinations with, like, device therapies like the Optune device?
spk09: Great question. And I think, to be quite honest, although we've had very intriguing conversations with our collaborators at Johns Hopkins about these very issues, it is a little premature for me to tell you about where this is going to go once it becomes a clinical project, because right now we're focusing on demonstrating the preclinical value of this thinking, which we think is going to be very interesting, but I think we need to provide a little bit more data before we move toward answering those questions. But we're certainly thinking about them, and I think Ultimately, I hope we get where you want to go with this, but I think it's too early to say.
spk14: Okay. Thank you, Mark, and thanks for taking our questions.
spk10: Thanks, Paul. Thank you. Our next question comes from Leland Gershaw with Oppenheimer. Your line is now open.
spk04: Hey, good morning, everyone. Thanks for taking my questions. I wanted to ask, you know, as the GemLighter launch, you know, rolls forward and there's more experience in the field, Just wanted to ask if you are aware of the kinds of patients who are getting the product. Is it, you know, are there certain characteristics of anatomy? Is it, you know, surgical eligibility? Or is it kind of across the board and more dependent on just, you know, those centers and those providers who are, you know, able to have access to give the product? Just wanted some more color on kind of the population of patients and their characteristics, I guess, for anybody who can answer. Thank you.
spk13: Yeah, Jeff, I think it's probably the best person to answer that question. Jeff?
spk06: Sure. So at launch, it was probably more the recurrent pool of patients of late. It's across the board, as you stated. So we're seeing physicians use it in an unresectable population or even a resectable. They'll go in, remove what they can see, and then come back a week or two later with six doses to clean up what they can't see or can't get. So it's fully what I expected at launch. You know, the first few months where patients were recurring, they knew their cancer was back. Physicians wanted a different treatment option. And as we evolve and we go in and we get face-to-face interaction and we promote the entire indication, physicians start to think about other patients, and we're starting to see that, that could benefit from gel mito. Great. Thank you. That's helpful.
spk04: Thanks very much.
spk10: Thanks, Laila. Thank you. I'm not showing any further questions at this time. I would now like to turn the call back over to Liz Barrett for closing remarks.
spk13: Thank you, Operator, and thanks to everyone. As we look forward to the remainder of 2021, we're very enthusiastic. We feel like we're having a significant impact on patients, and we're seeing that, as we talked about with John Maito, You know, we have the people, we have the financial strength to drive Gemmido and our pipeline forward. So we'll continue to provide updates throughout the year as we execute on our long-term strategy. So I just want to say thank you to everybody for your time today, your interest and support. So operator, you may now disconnect.
spk10: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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