UroGen Pharma Ltd. Q2 FY2021 Earnings Call

Good morning, ladies and gentlemen, and thank you for standing by. And welcome to UroGen Pharma's Second Quarter 2021 Financial Results and Business Update Conference Call. It is now my pleasure to turn the call over to Sara Sherman, Head of Investor Relations at UroGen Pharma. Please go ahead.

Thank you, Operator, and welcome everyone to UroGen Pharma's second quarter 2021 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended June 30, 2021. The press release can be accessed on the Investors portion of our website at investors.urogen.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 patience and understanding should we have any technical difficulties. During today's call, we will be making certain forward-looking statements. This may include statements regarding the success and timing of our ongoing commercialization of Jelmyto, planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, 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 and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. I will now turn the call over to Liz.

Thank you, Sara, and thank you all for joining us today as we provide an update on our progress and recent corporate development. At UroGen, we believe patients deserve better options, and we're steadfast in our approach to fundamentally change the way uro-oncology is treated today. As we move into the second-half of 2021, one of our key priorities remains the increased adoption of Jelmyto, the first approved therapy from a novel reverse-thermal hydrogel technology platform. As we announced in July, we recorded $13 million in Jelmyto net product sales for the second quarter of 2021, and $20.5 million for the first-half of 2021. We believe this early success with Jelmyto provides proof of concept for the broader platform both in low-grade disease with UGN-102, as well as our expansion into high-grade disease and other tumor types. We are focused on changing the way urothelial cancers are treated, an area where there have been no significant advances in recent years. And we see Jelmyto as our first opportunity to make a positive impact for patients. It's critical for patients to have alternatives to invasive and/or repetitive surgeries which have a well-defined associated morbidity, including negative outcomes from the use of general anesthesia. Our novel technology has enabled us to deliver Jelmyto and expand with our second uro-oncology investigational product candidate, UGN-102, which is being studied in low-grade intermediate risk non-muscle invasive bladder cancer, a large patient population where there are no non-surgical primary treatment options. Our RTGel platform enables us to develop these novel therapeutic approaches, and we are enthusiastic about their potential. Mark will provide a more detailed update on the UGN-102 Phase 3 ATLAS study, but we are pleased with the progress and interest to date from centers around the world. While we focus on expanding our pipeline, we have also made progress in our commitment to expand Jelmyto's geographic presence. We announced our first collaboration, which involves a license and supply agreement, with Neopharm, to pursue regulatory approval and commercialization for Jelmyto in Israel. UroGen was founded in Israel, and they played a key role in our pivotal trial. We look forward to the possibility of patients in Israel having access to this innovative treatment as quickly as possible. The two other priority regions for near-term expansion are Japan and Europe. Based on the work we have done today, we believe we have a plan for Jelmyto regulatory and reimbursement pathways, and look forward to providing more detail on our ex-U.S. strategy in the coming months. As we have communicated, our goal remains to establish our first two medicines as standard of care, changing the way these patients with low-grade disease are treated. We believe by doing so, these two lead products set a strong foundation for our company. And assuming regulatory approval of UGN-102, our goal is to deliver peak revenues of over $1 billion by the end of 2027. Given the total market size of low-grade UTUC is over $700 million and low-grade intermediate risk non-muscle invasive bladder cancer over $3 billion, we believe this goal is attainable, and positions UroGen as a leader in uro-oncology. Beyond Jelmyto and UGN-102, we continue to expand and progress our early-stage pipeline, both internally as well as with academic collaboration. And Mark will talk more about these programs. We are actively seeking opportunities to expand our portfolio with innovative medicines in areas for which there are no adequate treatment, and where new technologies and innovation can make a difference for patients. And we will share updates as available. And with that, I'd like to turn the call over to Jeff to provide a commercial update. Jeff?

Thank you, Liz. I'm pleased to provide you with an update on our commercial launch of Jelmyto. During the second quarter, we saw some return to a sense of normalcy with respect to the commercialization of Jelmyto, and access to physicians, and have been able to benefit from a higher level of in-person physician interaction. Challenges do remain with 30% to 40% offices closed to representatives as we monitor the evolving COVID situation, and the potential further impacts the pandemic may have on the business, physicians, and patients. As we enter the fall conference season, we look forward to having a major presence at key urology conferences, including the American Urological Association, or AUA, which will be held from September 10th through the 13th in Las Vegas, and is the largest medical conference in the urology space. AUA will be a hybrid, virtual, and in-person meeting this year. It will allow UroGen the opportunity to meet with physicians, and provide education on Jelmyto. We will have both a virtual and in-person booth, including an interactive patient builder, and demonstrations on how our innovative hydrogel technology makes chemoablation possible. We'll have a product theater, with Dr. Katie Murray focused on how Jelmyto is transforming the treatment paradigm in low-grade UTUC, moving away from previous surgical treatments to the first drug therapy of its kind. Since launch, physician response to Jelmyto has been positive, and we've been able to leverage the growing enthusiasm to increase the number of sites treating patients, as well as the number of patients treated in each site. We expect this growth to continue, alongside the total number of active sites as we expand field engagement. As of August 1, we have increased the number of activated sites to 407, up from 316 as of May 1. These are sites that have either treated patients or have completed all of the internal processes required to allow them to treat patients. For repeat accounts, we have increased the number of repeat accounts to 63, as of August 1, up from 40 as of May 1. This suggests that physicians are seeing clinical efficacy of the therapy and benefit to patients, that reimbursement is working, and all the components of the process are running smoothly. We also hear from physicians that the education and support received from UroGen's staff and nurse educators along the treatment continuum is critical to seamless integration of Jelmyto in their practices, and that practices are receiving timely and accurate reimbursement across Medicare and commercial covered lives. We consistently watch this number to ensure that physicians are identifying additional patients, and gaining more and more comfort using our therapy. Reflecting on our strong quarter, we do believe that there was some impact from patients who decided to wait for their vaccinations in the first quarter, who were then treated in the second quarter. And we're pleased that patients are returning to their physicians and seeking treatment. In-person engagement with the physician and office is critical, given the administration of the therapy, as well as the orphan drug nature of the disease. And this remains an important focus for our field team. As we look to the second-half of the year, we see the importance of depth in each account. We will focus on expanding the physicians and patients in our current accounts, and leveraging the positive experience peers have with our treatment to increase the number of physicians utilizing our therapy. With that, I'll turn the call over to Mark to discuss our recent clinical updates.

Thank you, Jeff. I'll now touch upon the progress we have made on our clinical and non-clinical programs this quarter. Starting with Jelmyto, we are paving the way to do something different in uro-oncology. As we explore ways to optimize treatments and think through lifecycle management, it is incumbent on us to ensure physicians and patients are utilizing Jelmyto in the most optimal and appropriate manner for patient success. And we are committed to generating the data to support our key stakeholders. We plan to start a registry, and are also working with clinicians to better understand the use of administering Jelmyto via nephrostomy tube in clinical practice. We expect to see data from nephrostomy tube use in the community starting later this year. As Liz mentioned, our leading late-stage clinical program is UGN-102, for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer. And we are actively enrolling patients in the ongoing ATLAS trial studying UGN-102 plus or minus TURBT, compared to TURBT alone. As an event-driven Phase 3 trial, we expect it will take approximately one year to enroll, and an additional two years to complete, targeting an approval potentially by the end of 2024. This is a very important patient population, where the current standard of care is repeated surgery. And we are seeing that there is significant demand with nearly 100 sites activated in the U.S., Europe, and Israel, and the momentum in enrollment is picking up. We look forward to providing updates for ATLAS later this year. We've talked about the trial design for this study, and how we relied on our Phase 2b OPTIMA II study to help inform the design and assumptions for the trial. We anticipate presenting the final OPTIMA II data at a medical meeting this year, as well as publishing the results in a peer-reviewed journal. In addition to the OPTIMA II publication, we have sponsored research in a variety of areas of special relevance to our programs, including work on patient preference for non-surgical options in non-muscle invasive bladder cancer, and the natural treated history of non-muscle invasive bladder cancer in a U.S. HMO population. We have worked with our colleagues in academia to examine the financial impacts and medical complication rates associated with current standards of care for NMIBC in the U.S., and we expect data from these studies to be presented at a medical meeting later this year. In parallel to the ATLAS trial, we are also on track to begin our home installation feasibility study in the second-half of this year. The trial will be a small 10-patient study, with the goal to demonstrate that UGN-102 can be safely administered by a healthcare professional in the home setting. We expect to enroll at approximately five centers in the U.S. I'd like to touch upon the progress we've made in our early stage immuno-uro-oncology pipeline, namely with UGN-301, our CTLA-4 antibody, and UGN-201, our TLR7 agonist. We see UGN-301 as a foundational checkpoint inhibitor, and intend to study this agent as monotherapy and in combination therapy, including in combination with UGN-201, as well as other agents. We refer to the combination of UGN-201 and UGN-301 as UGN-302, and are initially studying this combination in patients with high-grade non-muscle invasive bladder cancer. In June, we started a non-human primate toxicity study for UGN-301, which is on a critical path as we move towards submitting an IND for this asset. We expect to have the results of the toxicity study by the end of the year. And assuming an acceptable toxicity profile, we'll submit an IND for UGN-301 in the first-half of 2022. We are actively working with MD Anderson to further progress our understanding of the synergy between UGN-201 and UGN-301, and are on track to start a study in humans later this year with UGN-201 to assess the immune-modulatory activity in the bladder. We expect to see additional non-clinical data throughout 2022 from both monotherapy and combination therapy. Last quarter, we announced a sponsored research agreement with Johns Hopkins University, aiming to understand how local administration of checkpoint inhibition may be useful in the treatment of glioblastoma. We continue to work with Johns Hopkins, and are exploring the possibility to expand to other molecules and other tumor types. Our team is also actively working, both in our own labs and with other academic centers, to explore our pipeline in other solid tumors. And with that, I'd like to turn the call over to Molly, who will discuss financials.

Thank you, Mark. And thank you to everyone for joining today's call. As mentioned by Liz and Jeff, we recorded net product sales of Jelmyto for the second quarter 2021 of approximately $13 million, and $20.5 million for the first-half of 2021. Cost of revenues for the second quarter 2021 were approximately $1.4 million, resulting in a gross margin of 89.1%. As we've mentioned on previous calls in periods prior to receiving FDA approval for Jelmyto, we recognized inventory and related the cost associated with the manufacture of Jelmyto as research and development expense. We expect this to continue to impact cost of revenues through the second quarter of 2022, as we deplete inventories that we had expensed prior to receiving FDA approval. As a result, our gross margin would have been approximately 87.7% versus the 89.1% for the three months ended June 30, 2021, if we had not sold Jelmyto units expensed prior to regulatory approval. Research and development expense for the second quarter ended June 30, 2021, were $12.1 million, compared to $8.1 million in the same period of 2020. Research and development also includes $1 million in non-cash share-based compensation expense for the second quarter ended June 30, 2021, as compared to $1.6 million for the same period in 2020. The overall increase in R&D expense relates to the initiation of our Phase 3 ATLAS study for UGN-102, at the end of 2020. Selling, general, and administrative expenses for the second quarter ended June 30, 2021, were $22.3 million, as compared to $24 million in the same period in 2020. The decrease in selling, general, and administrative expenses resulted primarily from the higher brand marketing expense in the second quarter of 2020 in preparation for the launch of Jelmyto, as well as a decrease in share-based compensation expense. Selling, general, and administrative expenses included $5 million in non-cash share-based compensation expense for the second quarter ended June 30, 2021, as compared to $5.5 million for the same period in 2020. For the second quarter ended June 30, 2021, we reported financing expense related to the prepaid forward obligation to RTW Investments of $3.1 million. As previously reported, and in accordance with U.S. Generally Accepted Accounting Principles, we expect to accrue approximately $12 million to $15 million in non-operating financing expense related to the RTW transaction, which is reported below the operating income or loss line. Cash payments in 2021 will equal 9.5% of net Jelmyto sales recognized subsequent to the May 2021 closing. For the second quarter ended June 30, 2021, we reported a loss of $26.2 million or $1.17 per share. This compares to a net loss of approximately $31.3 million or $1.44 per share for the same period in 2020. The net loss for the second quarter ended June 30, 2021, includes $6 million in non-cash share-based compensation expense. For the first six months of 2021, net loss was $52.2 million, as compared to $69.1 million for the same period in the prior year. This improvement in operating loss over the period was driven by our Jelmyto revenue of $20.5 million, as compared to $400,000 in the prior year. Total operating expense decreased slightly, to $67.1 million, as compared to $70.7 million in the prior year. Our guidance for 2021 operating expense remains unchanged, and is in the range of $155 million to $165 million. This includes estimated non-cash share-based compensation expense of $24 million to $28 million, subject to market conditions. Lastly, we closed the second quarter with $129.3 million in cash, cash equivalents, and marketable securities. This includes the $75 million in funding from RTW, which we announced early in the year, and which closed in May. Based on our current operating plan and cash position, we believe we will have sufficient capital to fund operations into 2023. As a biotech company, and as Mark indicated, we are always evaluating opportunities to expand the use of our platform technology. As such, we will continue to evaluate our cash needs to ensure we are investing in our future. With that, operator, I would like to turn the call over for questions.

Certainly. Our first question comes from the line of Leland Gershell from Oppenheimer. Your question, please.

Hi, good morning. Thank you for taking my question and congratulations on the nice commercial performance. Couple questions, first on Jelmyto. You mentioned that you're seeing increased repeat rates at an increasing number of centers. I wanted to see if you could share more color on kind of what's the feedback you're getting from physicians at those centers in terms of their interest in using Jelmyto again. And the types of patients in which they may be using Jelmyto with respect to degree of pathology and location of the tumors, and so forth? Then I have a follow-up. Thank you.

Hi, thanks, Leland. Jeff, why don't you take that? And, Mark, if you have any additional comments once Jeff is done, and then let's do Leland's follow-up.

Sure, thanks. So far the number of accounts that are treating more than one patient is due to a couple of things. You've obviously got peer-to-peer influence within that practice, so physicians will ask their peers how it went on a certain patient. Clinically, what we hear are positives from a field perspective, and they are sharing that with their colleagues. The representatives are really motivated to go in and expand the depth in those accounts. So the reps, between representatives doing a good job expanding the depth and physicians talking to physicians, that's really why we've seen an increase in the number of accounts treating multiple patients. We have to continue that. There's still a lot of potential within given accounts, given some of these accounts are 10, 15, 20-plus urologists in the account, so we'll continue to do that. As far as the patients treated, because we have so many that have been treated, I'll say it's been across the indication. We've had recurrent patients that have been treated, and I'm seeing more newly diagnosed patients or hearing more about newly diagnosed patients whose resection may be challenging. As I expected at launch, we started with more of the recurrent pool, and it'll evolve into probably about 50-50, half of them coming from the recurrent pool and half coming from the newly diagnosed.

Got you. Thank you, that's very helpful. And then a question for Mark, in terms of these collaborations, obviously MD Anderson, and then Johns Hopkins in glioblastoma, maybe if you could just give us a sense of how much further we should see additional potential academic-type collaborations materialize as you go forward with the potential application of the RTGel platform?

Thanks, Leland. A great question. As I think you've heard from Liz and Molly, we are very interested in exploring other opportunities for the platform. We know that the gel we're using can deliver a lot of different types of molecules for a lot of different types of venues within the body. So, the answer is I think you would expect to see more in time. We're very actively pursuing this. Liz may want to comment further.

Yes, that's correct. We do see a lot of interest from different academic centers in using the platform. Any time we get inbound interest we follow up on it. We've got a couple in the works right now that hopefully we can talk about in the next few months. In addition to that, we haven't actively gone out to other companies broadly, but we continuously look to determine whether there is opportunity and then proactively pursue those as well. We definitely believe we have an opportunity to continue to expand the usage of our very unique RTGel technology. Thanks, Leland.

Great. Thanks very much. I'll hop back in the queue.

Thank you. Our next question comes from the line of Chris Howerton from Jefferies. Your question, please.

Fantastic. Good morning, and thanks for taking the questions. First, Jeff, I wanted to ask what is the current status of utilization of Jelmyto in the different center types? I recall discussion of trends that you were seeing of additional equipment that physicians could augment their offices with to be able to instill Jelmyto in their locations, as opposed to going to an ambulatory surgical center. Could you touch on the trends you're seeing in terms of the different types of centers? And then the second question: I'm intrigued with the mention of the interactive patient builder for UTUC. What were the important variables or features that you found most educational to physicians heading into that experience? And third, Mark, I didn't hear any mention of any presentations at AUA this time, so just wanted to see if there was still any presence from either clinical or pre-clinical work that you had been describing?

So, Jeff, why don't you take the first two, and Mark can share what he can around AUA. We won't be able to share specifics yet, but we definitely have a lot happening at AUA.

Sure. Some of the trends we're seeing: physicians can give this in outpatient hospital, an ASC, a surgery center, or they make arrangements to give it in the clinic either via a nephrostomy tube or they bring portable equipment into the clinic. As expected, most of our administrations are still taking place in the hospital, but we're starting to get diagnoses more in the community settings. That's starting to balance out. You're starting to see diagnoses in the community setting and more administrations in their surgery centers, which they may own or have a strong affiliation with. So those are some of the trends we've seen. It's still a very small portion of the administrations via nephrostomy tube, but it is growing. We get a lot of questions around it, and we are hoping to collect a lot of data when we start the registry. Regarding the patient builder, the field actually has this tool right now. The patient builder is designed to capture the entire indication. The representative is able to build a patient profile, whether that's newly diagnosed or recurrent, number of tumors, size of tumors. It then extrapolates what the data tells us in OLYMPUS, and allows the field to really talk to the entire indication to make sure that every one of those 6,000 to 7,000 patients that we see every year, Jelmyto is considered. We're excited to expand upon that. The reps have that patient builder now.

Chris, thanks for asking about AUA. The organization has very specific rules about embargo related to accepted research that will be presented during the meeting. As Liz alluded to, we have a number of items coming up for presentation at the meeting this year, but the embargo has not been formally lifted. So, all I can tell you at this point is that we're going to be very busy, and we have a lot of exciting work to present. We expect the embargo will be lifted in the next couple of days, and at that point we'll be able to be more transparent about the specific research.

Okay, all right. Well, that's very clear. Thank you very much for taking the questions. I'll hop back in the queue.

Thank you. Our next question comes from the line of Ram Selvaraju from H.C. Wainwright. Your question, please.

Yes. If you could, first of all, maybe give us some background on the relationship with Neopharm, and what might be some perspectives regarding the local Israeli market and Neopharm's capabilities in that region?

Sure. They are one of the top commercial partners for many companies in Israel. We evaluated multiple options, including commercializing ourselves, but felt Neopharm has the capability and infrastructure that fit nicely with what they're already doing. It is not a huge market, but it's meaningful to us because UroGen was founded in Israel. Neopharm played a significant role in our pivotal trial and has been great to work with. We feel very good about the decision. We'll be looking for similar types of partners as we expand globally — partners that can bring added capability if we do not commercialize ourselves in a region.

Has Neopharm expressed any interest in commercializing the product in countries outside of Israel, or would you need to seek partners distinct from Neopharm for those territories? And if so, give us an update on how the discussions are progressing?

They were interested in other countries, but we want to be thoughtful about who we partner with in which geographies. We want partners that are top in their regions and won't dilute effort by having too many small partners. We've had inbound interest from pretty much every region in the world, but we've focused on understanding what it takes to get approval and reimbursement in Europe and Japan. We are close to having a full plan in place and have started conversations with companies that have expressed interest. Ideally we'd like a single strong ex-U.S. partner covering Europe and Japan, and possibly China, but China is unique and may require a separate approach. We're engaging experts and leveraging internal experience to ensure we negotiate the best deal for the company and our shareholders. Those discussions will start in the fall, and we expect to provide updates over the next two months on the path forward. For Japan, there will likely be a bridging study focused on safety. For Europe, it's about reimbursement strategy and positioning versus generic mitomycin. Now that we have more understanding of what it takes, we will begin those conversations.

So, just as a follow-on, are you seeing any evidence that, specifically within the context of Europe, potential partners want to actually see not only regulatory approval but also reimbursement discussions completed before they would be interested in getting involved? Or could potential partnerships be consummated before all of that is set in stone?

We've been having conversations with some payers and engaging experts so that when we talk to partners we have a clear view on reimbursement. In Europe, market access capability is critical, so we'll be looking for partners with that strength. We're in a position now where we have enough information to start those discussions and evaluate potential partners effectively.

Okay. And then given the rise of the Delta variant, are you seeing any evidence that if further restrictions are placed on face-to-face promotional activity or clinical site recruiting activity, that either the continued rollout of Jelmyto or enrollment in the ATLAS trial would be affected, and if so, in what way? Or do you think that this is something you can manage through on both of those fronts?

I would be remiss to say there is no impact — things are changing daily. We've seen accounts that were going to open access now shutting down access. I had a personal experience where a family member couldn't get a hospital bed because of COVID. We continue to see good access overall but with restrictions. For ATLAS, we have many sites up and running across different regions, and if needed we can pivot enrollment geographically, which is one reason we wanted broad site activation. I don't believe the Delta variant will shut down our business; it might impact the ramp but not our ability to continue. Patients who are vaccinated are more comfortable seeking treatment. I'm also excited about nephrostomy tube administration; if hospitals reduce elective procedures, nephrostomy administration could increase, and we will support physician offices for that route.

Okay, and lastly, did you provide a timeline for completion of the non-human primate study with UGN-301? I apologize if I missed that.

We haven't provided detailed timing beyond noting that we're moving along and expecting data at the end of the year. We will likely decide to discuss further after the end of the year.

Yes, next year we will provide more detail.

Great, thank you.

Thank you. Our next question comes from the line of Matt Kaplan from Ladenburg Thalmann. Your question, please.

Hey, guys. Congrats on the good quarter. I wanted to follow up on the prior question: how have third quarter sales and new starts been shaping versus the second quarter? Have you been able to maintain the momentum seen in the second quarter, given the changing dynamics with the Delta variant? And another question for Mark: how will the nephrostomy tube data impact use and uptake of Jelmyto going forward, both in the context of the pandemic and further out after we're beyond it?

Matt, we're not providing month-over-month data around patients. I would say we continue to see patient enrollment forms come in and new patients being dosed. We continue to see growth in the numbers Jeff discussed, and expect adoption to increase over the next few months and beyond. We remain bullish about that. Jeff, could you comment on what you're seeing in the field? Mark, please answer the nephrostomy tube question.

Thanks. Reps are going deeper into accounts where we continue to see growth, and will continue to do so. They have a tool to help expand to the full indication, and we're excited for the first live meetings such as AUA to help finish the year strong.

Matt, regarding the nephrostomy tube: the pivotal study was done entirely in a retrograde manner, meaning the drug was instilled into the kidney through a catheter placed through the urethra into the bladder, and then into the kidney. Practitioners have started placing a nephrostomy tube, which is a tube placed directly through the skin of the back into the kidney, providing direct access without the need for lower urinary tract instrumentation to deliver Jelmyto. Anecdotally, it is a very acceptable method both for practitioners and patients. Initially there was concern a nephrostomy tube would be an encumbrance for patients, but it has actually proven convenient, well tolerated, and significantly simplifies office workflow. A patient can come into the office, expose the port, the practitioner instills the drug, and the patient goes home. We're hearing that there are a lot of advantages, both in terms of office workflow and patient acceptability, and we expect presentations and papers on this topic in the coming year. If these anecdotal reports hold, there could be a significant uptake of this delivery mode.

Okay, that's very helpful. Thanks for the added detail. And one last question: any plans to change your commercial footprint at this point?

No, not really. We are adding a couple of clinical nurse educators because the success and support provided to physician offices has been important. Other than that, the footprint should stay the same.

Okay, very good. Thanks for taking the questions.

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

Hi, thank you. Good morning, everyone, and congrats, Liz and team, on the strong quarter. A couple questions: Paul asked about the community setting — could you elaborate if this is more early trialing by practitioners in the community or reflective of Jeff and team beginning their next wave of targeting accounts? And on the pipeline side for UGN-301, have you identified directionally where you would go in other solid tumor types, and would additional combination development be pursued as investigator-sponsored trials or company-sponsored?

Jeff?

I would say it's the next wave. Physicians are looking to bring back revenue, and there's been a push to bring back revenue in the surgery center. Those diagnosing in the community are opting to administer in their surgery center. We expected to start in hospitals and move into community settings as we grow.

Okay, thanks for that color. Then on 301, I know you mentioned the non-human primate work completing around year-end. You described it as a foundational asset for additional solid tumor types. Have you identified where you'd go and whether you'd pursue combinations as investigator-sponsored or company-sponsored trials?

Great question. We're just starting to look at other areas. It would be both investigator-sponsored and company-sponsored work. We have investigators interested in certain uses, and we will also consider partnerships with other companies if we see complementary assets in development. Anti-CTLA-4 efficacy is well known, and our ability to deliver it locally could offer advantages in efficacy and safety. If we can do that in combination, we see a lot of opportunity.

Okay, thank you very much, Liz. I'll hop back in queue.

And 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, and thanks to everybody for joining us today. As we look forward to the remainder of the year we're really poised to continue to advance our efforts, both our commercial efforts and our pipeline priorities. We'll continue to provide updates, as we always do, as we leverage the proprietary technology we have, deliver on our promise to bring patients these novel therapies in areas where there really has been little innovation. So, while we do recognize the COVID landscape is evolving daily, we keep a close eye on it and the potential impact that it has to both patients and the healthcare system. We still feel very positive and optimistic about patients' ability to come in and get our medicine. So it remains fluid; we can't predict the impact. But we consistently work and we know we have the flexibility and adaptability to respond to whatever situation there is, because we are committed to ensuring that patients have access to Jelmyto. Again, thanks for your interest in our company. We look forward to more dialogue. Operator, you can now disconnect.

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.