UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the EuroGen Pharma's fourth quarter and full year 2020 financial results and business update conference call. It is now my pleasure to turn the call over to Sarah Sherman, Head of Investor Relations at EuroGen Pharma. Please go ahead.

Thank you, Jonathan. Good morning, everyone, and welcome to EuroGen Pharma's fourth quarter and full year 2020 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter and year ended, December 31, 2020. 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, Dr. Mark Schoenberg, Chief Medical Officer, Jeff Bova, Chief Commercial Officer, and Molly Henderson, Chief Financial Officer. Please note that we continue to conduct our calls from different locations, so we appreciate your patience and understanding should we have any technical difficulties. Liz will provide a summary of our recent corporate development, Mark will share clinical development updates, and Jeff will provide a commercial update. Molly will then provide an overview of our financial highlights for the fourth quarter and full year before we open the call for questions. During today's call, we will be making certain forward-looking statements. These may include statements regarding the timing of our ongoing and planned clinical trials, gel mito commercialization, data presentations, potential regulatory filings, future research and clinical development efforts, our ability to change treatment paradigms, manufacturing capabilities, future expectations, plans, and prospects, and 2021 financial guidance, among other things. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of Eurogen Pharma's annual report on Form 10-K filed with the SEC this morning and other filings that Eurogen Pharma makes with the SEC from time to time, as well as any negative effects on Eurogen's business, as well as commercialization and product development plans caused by or associated with the COVID-19 pandemic to the extent not disclosed previously. We encourage all investors to read the company's annual report on Form 10-K and and the company's other SEC filings. These documents are available under the SEC filings section of the Investors page of URGEN's website at investors.URGEN.com. In addition, all information we provide on this conference call represents our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future events, or otherwise. I will now turn the call over to Liz.

Thank you, Sarah, and thank you to everyone joining us today. It's not an understatement to say that 2020 was memorable for everyone. Despite the challenges we face collectively, it's been inspiring to see how innovation in the pharma and biotech industries have persevered to the benefit of society. Although this is what our industry does day in and day out, I am grateful to see the heroic efforts being universally applauded. While that work has rightfully been on the forefront, many diseases don't become front-page news, but they do take center stage for the individuals who have been diagnosed. Urogen is focused on developing treatments focused on urologic and specialty cancers. Last year, our first approved therapy, Gelmito, became the first and only FDA-approved non-surgical treatment option for adult patients with low-grade upper tracheothelial cancer. Although launching Gelmito in the midst of the COVID-19 pandemic certainly presented challenges, we are incredibly pleased with the way our team has responded to those challenges in the first two full quarters of launch. We recorded $8 million in net product sales for the fourth quarter of 2020 and $11.8 million since the June 1, 2020 launch. We continue to be mindful of the environment we're operating in, including the vaccine rollout and its impact on the healthcare system and the patient populations we serve. We have seen these trends have an impact on patient procedures, including gel mito uptake, in the first two months of 2021. We continue to closely monitor, and Jeff and Molly will provide more details on our progress shortly, but we remain confident in the outlook for continued and accelerated adoption as the year progresses. And the demonstration of what's possible makes us even more enthusiastic for what's to come. We've made important progress in advancing our pipeline and executing on our near and long-term growth strategy. Most recently, we initiated the ATLAS trial, our Phase III clinical study of our lead product candidate, UGN102, for patients diagnosed with low-grade intermediate-risk non-muscle-invasive bladder cancer. We're very excited about the UGN-102 program for many reasons, but mainly for the significant unmet need in this patient population with no FDA-approved primary treatment options. We believe that there are important similarities across the therapeutic indications for both gelmito and UGN-102, and we hope to leverage our learnings and experience from gelmito and apply those to UGN-102 and its potential for these approximately 80,000 patients annually in the U.S. alone. The low-grade intermediate risk patient is a unique patient population identified as at high risk for recurrence, and current standard is just not good enough. In our Phase IIb study, 57% of patients had received three or more TURBT surgeries prior to enrolling in the trials. These patients deserve better options, and if UGN-102 is approved, these patients may benefit from the first primary non-surgical treatment option. We were very encouraged by the data we shared from the Optima 2 trial, showing a strong, complete, and importantly, durable response, and believe it supports UGN-102's potential as an outpatient treatment option for these patients. We intend to present these data at an upcoming medical meeting and publish in a peer-reviewed journal. Our work extends beyond low-grade disease to high-grade disease. Our early-stage programs, most notably UGN302, is initially being studied in high-grade non-muscle-invasive bladder cancer, a life-threatening disease with risk of progression. We believe that UGN302, which is a combination of UGN201, our TLR7-8 agonist, and UGN301, the anti-CTLA-4 antibody that we license from a genus, combined with our gel technology, has the potential to transform this disease and provide an advance to currently available treatment options. The recently announced three-year research collaboration with the University of Texas MD Anderson Cancer Center is aimed at advancing this combinatorial intravascular immunotherapy for the treatment of high-grade non-muscle-invasive bladder cancer, with an initial focus on UGN302. We're particularly excited to leverage a collective experience of Dr. James Allison and Dr. Pam Sharma, who have both been instrumental in developing breakthrough therapies with MEO oncology. We continue to expand our focus in MEO therapy research, utilizing our proprietary technology with checkpoint inhibitors, as reflected in this week's announcement of a non-clinical sponsored research agreement the Johns Hopkins University, to explore this combination in glioblastoma multiforme, or GBM, an aggressive and difficult-to-treat brain cancer. These two important programs with world-renowned academic institutions are part of our ongoing efforts to expand our pipeline and realize the full potential of our proprietary RTGL platform. As we look ahead, we are pleased to announce that we completed a strategic transaction with RTW providing funding of $75 million. We believe this will serve to fuel our mission to advance and bring life-altering therapies to patients. Molly will provide additional detail on this important transaction shortly, but this funding ensures a solid financial outlook for our company. As we look ahead, we are building a company to transform how we treat specialty cancers and urologic diseases. We have and continue to deliver on all of our commitments, and I am proud of the work we are doing. We face challenges every day, and our colleagues rise to overcome barriers because we share a vision to have an impact on patients that need our medicines. We have a strong foundation to ensure a long-term growth business and realize leadership by delivering new approaches to patients that have been left behind. With that, I'll turn the call over to Mark to discuss our recent clinical updates. Mark?

Thank you, Liz. It's exciting to see the impact gel mito is having on real-world practice and an exciting time for patients as we continue to expand our pipeline in important areas of uro-oncology. During the fourth quarter of 2020, Dr. Serena Matten from MD Anderson presented the final durability data from our Phase III Olympus pivotal trial evaluating gel mito in low-grade upper tract urothelial cancer in a virtual podium presentation at the 21st Annual Meeting of the Society of Urologic Oncology. We were pleased to see that in both the Olympus intent to treat population and in the subpopulation of patients who were deemed to have unresectable disease at study entry, 58% of patients achieved a complete response with durability of response at 12 months estimated to be 81.8% by Kaplan-Meier analysis. Median time to recurrence was not reached. The safety profile in the Olympus data was consistent with previously reported results. This was previously a disease where options for patients included multiple endoscopic procedures or the removal of the kidney and ureter, both of which had consequences impacting patient health and quality of life. These final durability data from Olympus were in line with our expectations and support the use of gel mito as a less invasive, kidney-preserving, durable treatment for low-grade upper tract urothelial carcinoma, which may reduce the need for multiple endoscopic procedures or loss of a kidney. We also have several updates to provide for our UGN 102 program since our last quarterly call. The first of which is the final top line data from the Optima 2 Phase 2B trial evaluating UGN102 as primary therapy in patients with low-grade intermediate risk non-muscle invasive bladder cancer that we announced in November. This study showed that 65% of patients, 41 of 63, receiving UGN102 achieved a complete response three months after the start of therapy. In this subset of patients, duration of response of 12 months from start of therapy was estimated by Kaplan-Meier analysis to be 72.5%. The median duration of response was not reached. Treatment with UGN-102 was generally well tolerated, and the safety profile was consistent with previously reported results, with mostly mild to moderate adverse events that resolved over time. In the trial, we observed typical symptoms of exposure to mitomycin, and no treatment-related serious adverse events were reported. As was mentioned, we initiated the ATLAS trial, our phase three study of UGN102, in December and are actively enrolling patients. ATLAS is a randomized controlled global study and will enroll approximately 630 patients and compare UGN102 plus or minus transurethral resection of bladder tumor, or TURBT, to TURBT alone. which is standard of care in patients diagnosed with low-grade intermediate risk non-muscle-invasive bladder cancer. We are following the same enrollment criteria used in our Phase 2b Optima 2 trial and expect to enroll a similar population. Patients will be randomized one-to-one to either upfront UGN-102 treatment or TURBT. And at the three-month time point, patients will be assessed for response. Patients who have demonstrated a complete response to either UGN-102 or TURBT will be monitored quarterly for evidence of recurrence. Patients who have tumor present on evaluation at three months in either arm will undergo TURBT and then enter identical monitoring for recurrence. The primary endpoint of the study is disease-free survival or recurrence-free survival in this disease. And the trial is a time-to-event analysis designed to evaluate non-inferiority and superiority. We expect the trial to take approximately one year to enroll and to be completed within approximately three years. There are no non-surgical primary therapies approved in this patient population. And today, patients are managed by repeated transurethral procedures under general anesthesia with a minority of patients receiving adjuvant water-based chemotherapy. Per published literature, two-thirds of patients have two or more recurrences and approximately one-fourth have five or more recurrences throughout the course of their disease. I see these patients in my practice, and with each recurrence comes an additional surgery. Although the risk of death from disease is relatively modest, the risk of repetitive surgery is real, and these risks include unintended hospitalization for bleeding and infection, as well as a recently reported risk of increased mortality following multiple surgeries for non-muscle invasive bladder cancer. It is our belief that the ATLAS trial is designed to effectively demonstrate UGN-102's potential to change the treatment paradigm by providing a useful non-surgical therapeutic alternative to patients so they can avoid the potential comorbidities and complications that come from repeated TURBT. We look forward to providing enrollment updates on this trial later this year. While there are many similarities with gel mito and UGN-102, and both represent important advances in patient care. One important differentiation is the additional ease of administration that we believe UGN-102 may offer patients. Given the feedback we've received from our clinical trials, including the potential for a nurse to administer UGN-102, we are planning a small feasibility study to assess the potential for at-home installation. We are currently in the final planning stages of this study and expect to start sometime this year. We will provide more details as we progress, but believe the potential ease and flexibility of administration could be an important differentiator for patients with this disease. We are also focused on expanding our immuno-oncology pipeline, specifically UGN 302, which is the combinatorial approach initially being developed for patients with high-grade non-muscle invasive bladder cancer. As Liz mentioned, UGN302 is a combination of UGN201, our TLR78 agonist, and UGN301, or Xalafrilamab, an anti-CTLA-4 antibody that we have combined with our RT gel technology. There are significant differences between high-grade disease and the low-grade disease that we focus on with gel mito and UGN102. High-grade non-muscle invasive bladder cancer is an aggressive and potentially life-threatening malignancy characterized by both a significant risk of recurrence and disease progression to muscle-invasive cancer. And we know that some patients with high-grade non-muscle-invasive bladder cancer respond to immunotherapy using Dacillus, Kelmet, Garin, or BCG. So there is a strong predicate rationale for exploring potentially better immunotherapies for the treatment of this patient population. As we've shared before, the non-clinical data that the UGN302 program has generated to date have been very encouraging, as the combination of UGN201 and an anti-CTLA-4 antibody resulted in improved survival and decreased tumor size in our murine model. Additionally, we observed changes in immunological markers, such as decreased T regulatory cells and a trend toward increased CD8 Treg ratios. It is our belief that the data generated today support the potential of locally applied combinatorial immunotherapy. We are thrilled to be collaborating with MD Anderson on this novel program, given their expertise in innovative clinical trials and infrastructure. We expect to progress the UGN 302 program this year, which includes potential non-clinical studies for UGN 301 and a combination of UGN 201 and UGN301, as well as clinical studies for UGN201. We are working closely with MD Anderson on next steps and trial designs, and we'll continue to share details as they are available. The second immuno-oncology program to highlight is an interesting new sponsored research agreement with the Johns Hopkins University, where we intend to explore, in a preclinical setting, the potential of checkpoint inhibitors combined with RT-gel in glioblastoma multiforme, or GBM. This program stems from our focus on expanding our novel ARCHI gel technology in combination with other medicines to provide treatment options for patients in diseases with significant unmet need and where local immune modulation may make a difference. Our focus with this program is GBM, an aggressive malignant brain tumor with a five-year survival rate of less than 5%. GBM is difficult to treat, and treatment options today are limited and typically include surgery followed by radiation and chemotherapy. It is the most common primary brain tumor with around 12,000 cases diagnosed per year. With this research, we will examine combining our novel RTGL technology with anti-PD-1 and anti-CTLA-4 antibodies, respectively, to assess the impact on survival in a mouse model of GBM. While early, we continue to investigate the potential of our RT-GEL platform in immuno-oncology and explore local applications of immunotherapy, both within our laboratory and in working with key academic centers who may leverage our technology in exploring therapeutic options. And with that, I'd like to turn the call over to Jeff to provide a commercial update. Jeff?

Thank you, Mark. I'm pleased to provide you with an update on our commercial launch of Gelmito. As Liz mentioned, we achieved $8 million in net product sales in the fourth quarter of 2020 and $11.8 million from the start of Gelmido's launch on June 1st through the end of 2020. This represents a great early start to the launch and is a testament to the important work the team is doing and the value that Gelmido can bring to adult patients with low-grade UTUC. The feedback that our team continues to receive from physicians treating their patients with Gelmido remains extremely positive. and we are seeing firsthand the tremendous impact that gel mito is making in the lives of patients. The most consistent and recurring themes we hear include patients avoiding surgery and achieving a complete response post-treatment, consistent with what we have observed in our clinical trial. We've heard from a number of physicians who have treated their first patient with gel mito, received a promising response, and are now working on identifying additional patients. In November of 2020, we announced that CMS established a permanent and product-specific J-code for Gelmito, which took effect on January 1st of this year. The J-code replaces the previously issued and temporary C-code and standardizes and facilitates reimbursement in the hospital outpatient, ambulatory surgery center, and physician office settings of care. This J-code is helpful in simplifying and streamlining reimbursement for physicians, And we believe it will translate into improved access to Jalmito throughout 2021. There are a couple of data points I've been sharing on our calls to help illustrate the success of the launch to date and the growth that we've seen early on. The first is activated sites. As of March 1st, we have increased our activated sites over 250 sites up from 210 sites at the year end and 165 sites as of November 1st, 2020. These are sites who have treated patients or are ready to treat patients. We expect this number to continue to grow as our sales force of 48 reps continue to target hospital and community accounts where most of the patients are treated. The other data point that is important to note is repeat accounts, or accounts that have treated more than one patient. As it suggests, the physicians are seeing clinical efficacy of the drug, that reimbursement is working, and all of the other components of the process have gone well. As of March 1st, we have increased that number to 31 accounts, up from 24 accounts at year end and 13 as of November 1st. This is a critical factor demonstrating that the processes and support in place are working, and clinicians are identifying additional patients and gaining comfort in using this treatment. As we continue to expand the usage of Gelmito and reach additional target providers and accounts, we expect this number to become less relevant but believe it's valuable in the early stages of launch. We have also received compelling market research results showing the increased level of gel mito awareness, a testament to the team's efforts. As of November 2020, aided awareness increased to 94 percent, up from approximately 70 percent pre-launch. We also see a slight shift towards physicians viewing radical nephro-ureterectomies as less favorable than prior to gel mito's approval. and we expect to see that increase. I'd like to take a moment to highlight what we're seeing in the industry today and the impact of COVID-19. We saw that in 2020, cancer diagnoses were down about 40%, and from our own market research, it's evident that at least one-third of the patients are delaying treatment due to the pandemic. These phenomena are industry-wide, and in January 2021, based on the IQVIA data, elective procedures were down 25%. We are not immune to these trends and are also seeing patients with low-grade tumors deferring treatment. While we're optimistic for the future, January was the harshest month as it relates to COVID deaths in the U.S., and we want to share two potential trends that are important to note as the pandemic continues to evolve. Given the patient population with low-grade UTUC is generally in their 70s and make up the majority of patients being vaccinated in the early rollout, These patients have prioritized and we expect near term will continue to prioritize receiving the vaccine before seeking treatment. Additionally, at the hospital level, we are aware that some formulary reviews are being delayed because of the vaccine rollout as the hospitals are focused on prioritizing vaccines. These trends are resulting in a softer first quarter of 2021 than previously anticipated. That being said, we are seeing leading indicators of potentially new patient starts in the coming months, and all metrics reflect high physician and patient interest in adopting gel mito into their practice. Based on the recent interactions I've had in the field with physicians, I continue to hear that physicians are supportive of gel mito and its potential benefit to patients. We are closely monitoring this environment as the pandemic and vaccination rollout continues, but anticipate improvement in patient access to treatment providers and to Jelmido in the coming months as patients and physicians are vaccinated. We will continue to monitor and adapt to ensure patients have access to Jelmido. Although we are navigating the unchartered territory of this pandemic, our team continues to deliver, and I would be remiss if I didn't thank our team, as well as the many external parties involved, including our partners and our healthcare providers, for their continued efforts and commitment to patients. Our team's commitment to providing patients with our novel, effective, and potentially kitten-sparing treatment option remains unwavering, and we believe our experience with Telmido bodes well for potential commercialization of UGN-102 if approved. And with that, I would like to turn the call over to Molly, who will discuss financials.

Thank you, Jeff, and thank you to everyone who joined today's call. Before I discuss our fourth quarter and year-end 2020 financials, I'd like to touch upon the strategic transaction announced this morning with RTW and provide some details. We are pleased to partner with RTW, an influential healthcare investor whose mission is to invest in innovative companies looking to bring important new products to patients. RTW is research-driven, and we believe this investment reflects their confidence in the URGEN team and the important impact that Jelmido has on patients, as well as the excitement surrounding the potential opportunity for UGN-102 and non-muscle invasive bladder cancer. The $75 million in funding from RTW puts us in a solid financial position to support the continued launch of Gemido and the development of UGN 102. In return, RTW will receive tiered future cash payments based upon global annual net sales of Gemido equal to 9.5% of annual net sales up to $200 million 3% of annual net sales between $200 million and $300 million, and 1% of annual net sales above $300 million. If certain annual revenue thresholds for Gemido aggregate worldwide net sales are not met, the future payments with respect to the first year of net sales will increase by 3.5%, and then subsequently decrease depending on meeting certain annual net sales thresholds. In addition, RTW will receive tiered future payments based upon global annual net sales of UGN 102 subject to FDA approval equal to 2.5% of annual net sales up to $200 million, 1% of annual net sales between $200 million and $300 million, and 0.5% of annual net sales above $300 million. Payments based on net sales of both Gemido and UGN 102 will terminate upon the date that RTW has received an aggregate amount equal to $300 million. We are excited to partner with RTW, an industry leader, providing URGEN the solid balance sheet to execute on our mission. I will now take a moment to review the fourth quarter and year-end 2020 financials. URGEN recorded net product sales of Gemido for the fourth quarter 2020 of approximately $8 million. Full year 2020 net product sales of Gemido, which launched on June 1, 2020, were $11.8 million. Before turning to cost of revenues, I'd like to mention a few external trends that we're watching as we start 2021. First, as Liz and Jeff mentioned, we continue to be mindful of the evolving pandemic landscape and expect the vaccine rollout to have an impact on our first quarter 2021 results. Second, we are cognizant of the severe weather in the US throughout the first quarter of this year and the impact that it has had on shipments of gemido to patients. Lastly, Given the concerns over potential shipment delays around the year and holidays last year, we received several bulk orders at the end of 2020 that were recognized in 2020 revenue of approximately $500,000 to $800,000. We don't anticipate similar bulk purchases or stocking patterns in the first quarter of 2021. Based on these three impacts, we are carefully monitoring our Q1 revenues for 2021. Turning to cost of revenues for the fourth quarter of 2020 and the year ended December 31, 2020, cost of revenues were approximately $652,000 and $1 million, respectively, and included certain one-time startup costs. In periods prior to receiving FDA approval of Gemido and pursuant to accounting rules, we recognized inventory and related costs associated with the manufacture of Gemido as research and development expenses. We expect a favorable impact on cost of revenues through the first quarter of 2022 as we deplete inventories that we had expensed prior to receiving FDA approval. Research and development expenses for the fourth quarter year-end, December 31, 2020, were $12.4 million and $47.3 million, respectively, compared to $20.1 million and $49.3 million, respectively, for the same periods in 2019. Research and development expenses for 2019 included $10 million milestone payment related to our license agreement with Agenis. Setting aside that expense, research and development expenses increased by $8 million year over year. The increase of $8 million resulted primarily from a one-time payment of $6.6 million to unwind the company's obligation to the Israeli Innovation Authority during the first quarter of 2020 and increased expense related to UGN-102 clinical trial and UGN-201 studies. partially offset by the completion of the GMIDO Phase III clinical trial and reduced regulatory activity. Research and development expense also includes $1.4 million and $6.4 million of non-cash share-based compensation expense for the fourth quarter and year ended December 31, 2020, respectively, as compared to $1.9 million and $8.3 million, respectively, for the same period of 2019. Selling general administrative expenses for the fourth quarter and year end in December 31st, 2020, were $22.2 million and $90.2 million, respectively, as compared to $19.7 million and $60.2 million, respectively, for the same periods in 2019. The increase in annual selling general administrative expenses resulted primarily from increased costs and activities related to the commercial launch of Delmido in June of 2020, including headcount and related costs associated with building our sales force and administrative costs. Selling general administrative expenses included $5.1 million and $21.6 million of non-cash share-based compensation expense for the fourth quarter and year-end in December 31, 2020, respectively, as compared to $6.2 million and $21.7 million, respectively, for the same periods in 2019. The fourth quarter and year end December 31st, 2020 reported a loss of $30.5 million or $1.38 per share and $128.5 million or $5.90 per share respectively. This compares to net losses of approximately $39 million or $1.86 per share and $105.1 million or $5.12 per share respectively for the same period in 2019. The loss for the fourth quarter and year-end of December 31, 2020 includes $6.5 million and $28 million, respectively, of non-cash share-based compensation expense. Our guidance for 2021 operating expenses is in the range of $155 million to $170 million. This is largely driven by the initiation of our Phase III ATLAS study late last year. This includes estimated non-cash share-based compensation expense of $24 million to $28 million subject to market conditions. Lastly, we closed the fourth quarter in year with approximately $103.9 million in cash and cash equivalents and marketable securities with no debt. This was supplemented post-year end by the $75 million in funding we announced this morning from RTW. We believe we are in a solid position to execute on our strategy. With that, operator, I would like to turn over the call for questions.

Certainly. Ladies and gentlemen, if you have a question at this time, please press star then 1 on your touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue, please press the pound key. Our first question comes from the line of Chris Howarthen from Jefferies. Your question, please.

Excellent. Good morning, and thanks for taking the questions and really appreciate all the progress through a pretty difficult year last year. Um, great. So I guess maybe is, uh, to start things off, um, in terms of Jeff, um, for the, the repeat customers that you saw in terms of the accounts, you know, I guess I'm just wondering if there's any trends that you see there, um, categorically, is that more tend to be academic centers, community centers is, you know, what's your expectations there, um, or kind of what you're seeing first of all. And then secondly, With respect to the first quarter revenue numbers, I guess I just want to fully understand the expected dynamics to the net revenues. I think, Molly, you said that there were some weather-related shipment delays, and then there was also perhaps some larger orders in the fourth quarter. And then, you know, perhaps there's also something to be understood with respect to the payer environment, payment plan resets, or anything like that, I guess, just maybe help us better understand the expected dynamics for the first quarter revenue numbers. And I think maybe that's it for now, and I might have a follow-up.

Hey, Chris. Thanks. It's Liz. How are you? I'll turn it over to Jeff to answer your first question, and then, Molly, you can talk a little bit more about Q4 and Q1. So, Jeff?

Thanks, Liz. Hi, Chris. And to address your first question, the multiple or the patients or the physicians that have multiple patients, it's primarily probably 60% to 70% are those in the hospital, but we do have community accounts that have multiple physicians writing gel mito for their patients or single physicians that have identified more than one patient as well. So my expectations, I think, As I said in the past, I continue to expect this will translate more into the community. Some more community practices will begin to adopt and treat multiple patients. But for the time being, the predominant number of multiple patients are coming out of the hospital setting. Great. Okay.

And hi, Chris, to answer your question on the Q1 revenues. So as Jeff and I both alluded to, we started to see some softness as we went into January and February this year. A lot of the reasons we discussed in our narrative around the vaccine rollout and some other impacts as it relates to the weather. To that effect, we're starting to see the rebound of that. And I think when we look at the patient population that we serve, it was the same patient population that was getting the vaccination or in the queue to get vaccinated. And so that really trends in line with kind of the rebound we're seeing in March. We're still in the first quarter, so we're not going to provide any more clarity as far as where we expect because we still have a couple more weeks to go. But we certainly wanted to flag that to the market because those are some of the dynamics that we're watching. And then maybe lastly, as it relates to some of the stocking charges we saw last year, I referenced about a $500,000 to $800,000 estimate based upon some indication we got from certain practices that they were looking to stock and or get ahead of any shipment concerns. I remember last year's holiday season, there was a lot of delays in shipments. So we saw some of that in advance buyings. last year, and we're not going to see a similar pattern. So I wanted to cue the market into some of that dynamic as well.

Okay. Great. And maybe just as one clarifying question with respect to that, in terms of the shipment delays in the first quarter, did that impact any kind of treatment schedule or any effect in terms of the patients or just maybe like initiation of treatment? Just a clarification there and then Another question for Mark would be, you know, what do you expect the impact could be of in-home installation? And is that, you know, primarily in the context of a COVID environment, maybe very impactful and not so much outside of that? Or maybe just how you're seeing that would be helpful to understand. Thanks.

Do you want to take the impact to patient treatment?

Sure. So it did impact, you know, we had a few that needed to be rescheduled. Fortunately, and the Olympus trial was designed that though it's once weekly, you know, and not everyone was got a dose every seven days. So they were able to miss a day or two in the Olympus trial. Therefore, physicians felt comfortable. And obviously, you know, given the weather that we had, shipments were delayed by a day or two. They just simply rescheduled those patients.

Chris, thanks for the question about home installation. I think this is an example of something that Liz has really fostered in the company, which has been, I think, accelerated by COVID, which is thinking innovatively and out of the box. The concept of home care for patients with recurrent disease is really a very innovative one. but it's possible with this therapy. And so we want to explore that because we think it represents a very positive step in the right direction for this population. And obviously, you know, we have to do the study in order to examine whether it makes sense. But it is a really interesting, I think, and innovative way of thinking about the next iteration of treating patients. And COVID, I think, has made us think about this in an accelerated fashion. So I think it has had a little bit to do with COVID, but I also think it's completely consistent with our larger corporate goals, as you heard Liz articulate many times.

Yeah, okay. All right, well, great. Thanks so much for all the answers, and again, I appreciate all the progress.

Thanks, Chris. Thank you. Our next question comes from Derek from Stiefel. Your question, please.

Hey, good morning, everyone, and congrats on the news and the updates here. So just two questions from us. I think the first one's for Jeff. I just wanted to get an understanding of how you think the sales ramp and the trajectory for Jelmido may be impacted with the JCO now that you have it. Maybe you can kind of talk to some of the things that have happened or some of the trends thus far in the first quarter. And then maybe the second for Liz and Molly is, Now with the RTW investment, I guess, you know, do you think this is enough runway to get yourself to profitability? I'm just kind of curious how you're thinking about that. Thanks.

Yeah, Jeff, you can answer. So with regards to the date code, what we've seen, particularly in the community, the community, you know, whether it's warranted or not, tends to be a little bit, have a little bit more anxiety around miscellaneous code. And so they liked having the J-code, the product-specific code. They're being trained with the CMS giving guidance on how to bill correctly for the drug. So it certainly has helped with regards to uptake in the community. I expect it to continue as well, having a permanent J-code.

Molly, you want to give your perspective on the financing, and then I'll chime in as well.

Sure. Hi, Derek. Yeah, so we're excited to announce that financing this morning. We haven't provided any specific guidance on when we anticipate the breakeven, but it's safe to say this additional funding gets us into 2023 and certainly allows us the ability to continue the launch efforts that we have on Jelmido and the Atlas trial relating to 102.

Yeah, I think, Derek, the only other comment I'll make is, you know, we've had a lot of questions and comments from, you know, from investors and around needing to, you know, raise money, obviously, and people wondering where we're going to go back out to the market. And this is non-dilutive financing. And so we just, you know, I think this hopefully answers that question. And, you know, we don't have a need to go out to the market right now. And I think, you know, it depends. We're well-funded to do the things that we need to do right now. I think there's always a question of business development, right? If we find something we're excited about, we're constantly looking for new opportunities. So if we find something we're excited about, that might change things. But at this point in time, I think, you know, as you, I'm sure, can tell, we're funded where we need to be and don't expect to be doing any dilutive financing anytime soon. Okay. Thanks for the question.

Yeah, thanks, and congrats again.

No, thank you, Derek.

Thank you. Our next question comes from the line of Eric Joseph from J.P. Morgan. Your question, please.

Good morning. This is Hannah on for Eric. Thanks for taking the question. Just a few from us. So now that you're further into the launch, are you able to speak a little to the frequency of maintenance therapy use in the commercial setting? You mentioned earlier that a number of patients have seen a complete response, but have you been able to determine what proportion of patients are retrieving SCR and how that would compare to the Olympus trial? And then I have a follow-up after that.

Yeah, Jeff, why don't you take those?

Yeah, as I said, you know, it's consistent with what we saw on Olympus, the Olympus trial week, whereas, you know, the physician, if they choose to tell us how the patient is doing, that's You know, that's information that we have. We haven't really, you know, maintenance has been something that is at physician discretion. I will say this. We have more patients, more physicians considering maintenance and putting patients on maintenance, but, you know, the bulk of the majority of the patients are getting the treatment, the six doses with no maintenance. Okay.

Yeah, and the only comment about CR and what we're seeing is, you know, as Jeff commented, that's anecdotal, right? We don't capture, you know, real world. We're not capturing real world CR. But, you know, from what anecdotally, you know, I would say at least as good or better. And, you know, it's well tolerated. And we do capture, obviously, any AEs that have to come in. you know, to the company. And so we feel really good about not only the efficacy but the safety as well. So you said you had a follow-up question, Hannah?

Yes. You had mentioned a little while ago interest in pursuing a retreatment trial. Just wondering if that was still of interest and if there's any particular timelines where we might see that come to fruition.

Yeah, we're definitely interested in that. And we will start that study as soon as it's feasible. The reason I say that is because you know, patients have to recur, right? So they have to do well on the treatment and then have a recurrence. So we would not see to start that study. Obviously, patients are just starting on the treatment in the last six months. So we wouldn't expect to start that study until the end of this year or really into probably 2022. Having said that, just, you know, we do know that there were patients that were in the study that, you know, have gotten retreated. It is in our label today, but we would like to generate additional data on retreatment. It's not stopping physicians from retreating patients. As I said, it's part of our label, but we would like to capture data. But it will be quite a few months before we'll actually be able to even start that study.

Okay, great. Very helpful. Thanks for taking the question.

All right. Thank you.

Thank you. Our next question comes from the line. I'm Matt Kaplan from Latimer, Delman. Your question, please.

Hi, good morning, and let me add my congratulations to the progress. Just wanted to dig in a little bit to kind of the dynamics of patients receiving treatment that you're seeing, I guess, given the pandemic and patients not seeing the doctors as you and diagnoses going down. Are you seeing some sort of a backlog of patients given this backdrop? And do you think these patients have been ID'd by practices and are just awaiting therapy that you'll start to see them roll in to receiving the treatment sometime this year?

Yeah. Hi, Matt. It's Liz. Thanks for the question. I'm going to ask Jeff to comment. But before, you know, he does, I think we would speculate, right, that even in – you know, even in the beginning of our launch that there were some patients that, you know, had not come in as you saw, you know, COVID cases go down somewhat. We did, you know, Jeff did some nice work on understanding the dynamics of COVID versus, you know, versus our patients. And you can clearly see that when, you know, diagnosis of COVID went down, patients went up. So we do think that even in the first six months of the launch, there were likely patients that had been kind of waiting for You know, and so, you know, I think that dynamic exists. It's hard to quantify. But, you know, Jeff, I would love for you to share with Matt your perspective.

Sure. Thanks, Matt. And I guess to easily answer the question, it depends on where in the country you are, how bad the cases have been, when did they put into place if they put in a delay in elective procedures. I will say majority that had put in, you know, elective procedures or are on hold have now opened elective procedures up. And to your point, Matt, they do begin then to prioritize these patients. And so as we see, as we've seen with COVID going down, cases going down, we've seen an increase in patient enrollments.

Okay. That's helpful. Okay. And you mentioned in your prepared remarks that you have now, I guess, over 250 sites activated. Can you give us a sense in terms of the number of those sites that have treated a patient so far?

Liz, we haven't provided yet.

Exactly. Okay. And then I guess maybe a question for Mark on the the ATLAS study. Can you give us a sense in terms of, just remind us of the kind of the endpoint and the powering of that study for the low-grade intermediate risk non-muscle invasive bladder cancer?

Sure. Thanks, Matt. I'm sure as you probably remember in our discussions, the primary endpoint is recurrence-free or disease-free survival. And it's an event-driven trial. So the objective here is to look for curve separation between the group receiving primary EGN-102 versus those who are treated primarily with surgery. There are planned interim analyses that are event-driven, so we can't tell you when those will occur. And I think that's probably about what we've shared, along with the fact that we know that in the control arm, we expect recurrence rates to be approximately 50%. or higher at a year, we've been pretty conservative about our design. So I hope that's helpful in terms of thinking about the trial. But the primary endpoint is recurrence-free survival. And Liz may want to comment further on this as well.

No, I think that's right. I think that powering to your point, to your question, Matt, you know, as Mark said, you know, we used around 50% knowing that, In the literature, anywhere from 50% to 80% of those patients will recur if they only have a TRBT and, you know, meet the criteria for intermediate risk. And obviously, you know, we used our own Phase II data for the assumptions, but on a conservative side for us as well. So, you know, put ourselves in a position where we can be successful from a technical standpoint.

All right. Thanks for that detail, and thanks for the questions.

Thanks, Matt.

Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Your question, please.

Hi. Good morning, team, and let me add my congratulations on the progress as well. I wanted to maybe just revisit ATLAS, if we could, and just with regard to your comments with regard to patients being treated at home. I guess my question is twofold here. First, do you see this as potentially for this low-grade intermediate risk population as a potential real-world treatment paradigm versus being treated in the clinic or in the hospital? And then secondly, you know, if there is potential for, you know, an at-home treatment model here, how does that, you know, potentially affect the economics of UGN-102? or is this just more like a function of the environment we're in currently?

Yeah, you know, thanks, Paul. How are you? I think from our perspective, you know, we want to make things as easy as possible on patients. You start to think about TRBT. I think one of the misinformation or misunderstanding is that, you know, people think, oh, TRBT, no big deal. As we shared, 57% of the patients in our study, you know, had three or more TRBT. It's a patient population we're talking about. And as they have more and more, we know it's an independent, you know, factor of mortality. So, you know, we're saying how, one, can we differentiate our therapy from what's there today, which, frankly, doesn't work. And we do know that more and more, you know, this is an elderly patient population. So it's just one additional way to We still think that, frankly, the majority of the patients will go in, you know, to the clinic to get treated. But having an opportunity to treat these patients at home I think will be a benefit to some of those patients who are, you know, unwilling or unable to get to the doctor, make it, you know, make it easier on them. I don't think it will impact the financials, you know, at all because obviously, you know, you would get treated at home. You know, it would be through a home health, you know, company. So I guess the difference is for physicians, obviously they would make more money if the patient comes into the office. But the, again, ability to offer that to patients and have that as an option we think is important. So the financials for us won't really change. The financials for the, you know, for the office, you know, obviously would if, you know, if the patient came into their office, they would, you know, they would see the revenue associated with that.

Okay. Thank you for that concept, Liz. And then maybe as a follow-up either for you or for Jeff, just with regard to your comments on the, you know, the trends you're seeing so far in the first quarter here, Can you maybe just help us contextualize, in your view, is this more just specific to this quarter, given the various factors such as COVID that you mentioned here, or, you know, with regard to historical practice and in this population on the commercial side, is this more reflective, you think, of typical seasonality in the Medicare population and donut holes and those kinds of factors? Any clarity on that point would be great.

Yeah, Jeff, you want to comment and maybe I'll add something after.

Sure. Now, we have a very small number, you know, of patients at Medicare that don't have supplemental. I don't think that that's a great impact as much so as we've seen with sort of prioritizing the vaccine, both from a patient standpoint and a hospital or a provider standpoint. You know, the good thing is that the majority of accounts that we're you know, that we had out there or the accounts that we're pushing off formulary review are now reviewing. Things are starting to get back to normal within the provider. But there's a very minimal impact with regards to out-of-pockets because the majority of our patients have supplemental insurance.

Yeah, and just a comment about the trends. We, you know, we don't think that it will continue that way. As a matter of fact, as Molly mentioned, we've already seen it start rebounding in, you know, in March. So, you know, it made sense that these patients and the physicians want, you know, now that the vaccine's available, you know, wait a few weeks, you know, get the vaccine. There's tons of publications out there and literature out there that says that across the board, hospitals around the country, institutions around the country are doing that. Not, you know, not just obviously in this instance, but across the board. And so we don't expect to see that trend continue. And, you know, as Jeff said, we think we'll be in a good position. So for us, the outlook on the year hasn't changed at all, right? It's just more a timing thing.

Okay. Thanks for the call, Liz, and congratulations again.

Great. Thank you.

Thank you. And as a reminder, ladies and gentlemen, if you have a question at this time, please press star, then 1. Our next question comes from the line of Ram Selvaraju from HC Wingright. Your question, please.

Good morning. This is Maz speaking on behalf of RAHM. Thanks for taking our questions. I have a couple of COVID impact questions and then two follow-ups after that. So in terms of the gel meter of sales effort being conducted in the context of COVID-19, do you anticipate being able to conduct certain promotional activities in the coming months that you weren't able to perform previously? You know, because the COVID-19 pandemic is the curve coming down. And then in terms of the artless trial enrollment, you mentioned you expect to provide enrollment updates later in the year. But are you facing any logistical challenges in execution of the trial due to COVID-19? And, you know, if so, what are these and how are you mitigating them?

Thanks. Yeah, I'll comment about the study. I would say not really. We anticipated that there would likely be delays. So our expectations for enrollment, you know, from an amount of enrollment, obviously it starts slow anyway. We did make sure that we sort of were around the world doing the study. You know, there were a couple of countries that, you know, that delayed the start of the study, but then there were other countries that didn't. So we'll continue to work through that, but we feel like we have enough sites, and it's one of the reasons that we actually increased the number of sites versus our initial expectation, because we wanted to make sure that with COVID, if a country or area is shut down, that we would be able to sort of make up that enrollment elsewhere. So, and then, Jeff, you want to comment on promotion?

Sure. So what we've seen is an increase in face-to-face interactions. I was fortunate to get out with some accounts last week, a couple weeks ago, and the face-to-face is improving. So they're opening the up to face-to-face interactions. And more importantly, they'll open up to have representatives come in and do presentations over lunch. So a lot of places that have limited lunches or face-to-face interaction are slowly beginning to open those interactions up. Where that's still limited, we continue, you know, the field does an excellent job of continuing to have virtual reminders, virtual presentations with the physicians, being mindful and respectful of what the office prefers at this time. But I am happy to say that, yes, there's more face-to-face that are taking place. I can see that continuing as COVID cases go down.

Okay, excellent. And do you expect the difference between the number of sites activated and the number of sites, you know, that have treated more than one patient with gel meter to narrow substantially over the course of the next several quarters? And if not, why do you think that went on?

No, I expect both to grow. And, I mean, I think someone asked a question too. We want all of our sites activated treating more than one patient. I mean, we want to get to the point where, you know, physicians are opening it up. We've had that too. Initially you obviously have a champion in the office, but the ask and the goal of the reps, representatives are to go in and open it up to the other physicians. So I expect both numbers to continue to grow as we've got, you know, a large number of accounts that, you know, either are putting it on formulary, have it on formulary, looking for a patient. And then once they experience using gel mito with the patient, either finding more patients or certainly that peer-to-peer influence that I talk about, discussing it with other physicians during their – all of these accounts have tumor boards or medical meetings with their urologists. Making sure that we're part of that agenda is a key goal for us to get the majority of the urologists within an account considering gel mito for their patients.

Okay, great. And then just the final financial housekeeping question. Are there any time frame restrictions on the funding received from RTW investments. So, in other words, does RTW have a right to impose, you know, additional conditions that require additional consideration if the $300 million amount is not paid back within a specific period of time? And what are these additional conditions, if any? So is this funding from RTW secured by any of Eurogen's IP, perhaps?

Molly? Yes, sure, to answer that. There's no timeframe commitment in the event that $300 million is achieved over a certain period of time. So to answer that question, there's no time commitment. As far as collateral, certainly they have a security lien interest on the strip of Jelmido, and then that's carved out within the IP interest as well, but certainly nothing that we believe would prohibit us to look at XUS or other BD type activities in these products.

I think it makes sense. Thanks for taking our questions.

Great. Thank you.

Thank you. This does conclude the question and answer session of today's program. I'd like to hand the program back to Liz Barrett for any further remarks.

Great. Thank you, Operator. As we look back into 2020, we're really pleased with what we were able to accomplish, both with our first approved medicine as well as significant progress made in our pipeline. It's an exciting time in our company, and we're committed to ensuring that patients that need our medicines have access to them. As we look to the other side of the pandemic, hopefully, we look forward to continuing dialogue with you and as we advance our long-term growth strategy in 2021 and beyond. As always, we appreciate your support and interest in our company, and thanks for taking the time today. Operator, you can disconnect the call at this time. Thank you.

Thank you. And thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.