Good morning, ladies and gentlemen, and thank you for standing by. And welcome to the 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 Web site 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 studies 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 pervious 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.

Mark?.

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 kicking 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 TLR 7 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 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 UNG-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 the Johns Hopkins University, aiming to understand how local administration of checkpoint inhibition may be useful in the treatment of glioblastoma.

We continue really 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 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 expense prior to receiving FDA approval.

As a result, our gross margin would have been approximately 87.7% versus the 89.1% for the three-month ended June 30, 2021, if we had not sold Jelmyto units over expense 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 annual 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. [Operator Instructions] 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'd mentioned that you're seeing increased repeat rates at an increasing number of centers.

Maybe wanted to see if you could share more color on kind of what's sort of the kinds of 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 with Leland's follow-up.

So, Jeff?.

Sure, thanks. And so far the number of accounts that are treating more than one patient, it's a couple of things. You've obviously got peer-to-peer influence within that practice, so physicians will ask their peers how did it go on a certain patient.

Clinically, obviously what we hear are positives from a field perspective, and that they're sharing that with their colleagues. Obviously, as we said earlier, representatives are really motivated to go in and expand the depths in that account.

So the reps, between the 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, it has -- I'll say it's been across the indication.

We've had recurrent patients that have been treated, I'm seeing more newly diagnosed or hearing more newly diagnosed, that maybe their resection is going to be challenging.

And as I expected -- at launch, I expected to get more of the recurrent pool, and it'll evolve into probably at 50-50, half of them coming from the recurrent pool, half coming from the newly diagnosed..

Got you. Thank you, that's a --.

Go ahead..

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..

Thanks, Leland. A great question, and as I think you've heard from Liz and from Molly, we are very interested in exploring other opportunities for the platform. And 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. And Liz may want to comment further, but I think that there is more on the horizon..

Yes, my only comment is that is correct. We do see a lot of interest in them and with different academic centers and in using it. And so, any time we get an inbound interest we absolutely -- we absolutely follow-up on them. 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. And we will -- we continuously look to say to think about whether we believe there is opportunity. And then we'll proactively pursue those as well. So, definitely, we believe that we have an opportunity to continue to expand the usage of our very, very unique technology in the RTGel.

So, thanks. Leland..

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

Great..

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, I guess, Jeff, I just wanted to ask what is the current status of utilization of Jelmyto in the different center types, I think that there was some 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.

So, just kind of touching basis with the trends that you're seeing there in terms of the different types of centers? And then the second question that I had is, frankly, I'm just intrigued with the mention that you had at the AUA of the interactive patient builder for UTUC.

And I guess I was just curious what were the important kind of variables or features that you found important or most intriguing or most educational to physicians heading into that experience. And then the third question I had was -- if I may, is for Mark.

I didn't hear any mention of any presentations at AUA this time, so just wanted to see if there was still any kind of presence from either the clinical or pre-clinical that you had been describing? Thank you..

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

So, Jeff?.

Sure. Thanks, Chris. Yes, so some of the trends that we're seeing results is, as you know, physicians can give this in outpatient hospital, an ASE, a surgery center, or they -- as you said, they make arrangements to give it in the clinic either via a nephrostomy tube or they bring [indiscernible] into the clinic.

As expected, we still have most of our administrations taking place in the hospital. What I'm seeing a good trend in is that we're starting to get diagnosis more in the community settings. So, that's starting to balance out.

You're starting to see a diagnosis in the community setting, you're starting to see more administrations in their surgery center, which they may own or they have a strong affiliation with. And so that those are some of the trends we've seen, and I expected to see.

Obviously, if it's diagnosed in the community and they go to the hospital to administer it, that that's fine as well. But I do think you're starting to see an uptake both in diagnosis and administration in the community. And whether they do it in their surgery center or the clinic, it's entirely, obviously, up to them.

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. So, that was your first. The second, the patient builder; yes, so we're excited for this. The field actually has this right now.

The patient builder is designed to capture, as I was talking to Leland, the entire indication. So, the representative is able to build a patient, whether that's a newly diagnosed, whether that's recurrent, number of tumors, size of tumors. And then what it does, it extrapolates out what the data tells us in OLYMPUS.

And so, it 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. So, we'll expand upon that. We're excited for a live AUA. But yes, the reps have that patient builder right now..

Chris, thanks for asking about the AUA. The organization has very specific roles about embargo related to accepted research that will be presented during the meeting. And as Liz alluded to, we have a bunch of things coming up for presentation at the meeting this year. But, unfortunately, 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 stuff to present. And we can't talk about it yet, although we expect that the embargo will be lifted in the next couple of days, and hopefully 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. And I'll hop back in the queue..

Right, thanks, Chris..

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

Yes.

So, 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. Hi, Ram. They are one of the top, and I want to say distributors, but commercial partners for many companies in Israel. So, they have a very -- I mean we, as you can imagine, there was a lot of interest from multiple companies in Israel to be our commercial arm. We actually also considered do we do it ourselves.

But we felt like Neopharm has the capability, they already have the infrastructure. And it fit very nicely into the work what they're already doing. So, we worked very closely with them for Israel. And look, we've -- it's not a huge market, right, let's realistic about that.

But it's a -- it's very prideful for us, right, as we are an Israeli company, we started in Israel. They were a big part of what we've done. But Neopharm, we looked, like I said, at all of the different options, and felt like, both from a financial and a capability standpoint, it made the most sense to do a partnership.

And Neopharm, of all the companies, rose to the top because of their capability. And they've been really great to work with. So, we feel very good about that decision. And we'll be looking for similar type of partners, frankly, as we expand globally.

You want partners that -- that if we're not going to do it ourselves, that can bring that added extra capability. And we believe that Neopharm does that in Israel..

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?.

Sure. They were interested in other countries, but as we talked about before, we think it's really important for us to be very thoughtful about who we partner with in which geographies, right. We want to make sure that the partners we have are the top partners in those geographies.

And I think what we also want to make sure we don't do, is have so many partners that one dilutes the effort, both our internal resources, but also the potential to have a bigger partner worldwide. So, we have not started, even though we have had inbound interest in different regions.

And I would say pretty much every region in the world we've had inbound interest. But we want to be careful that we don't just, again, have 10 different partners in 10 different regions around the world, but be a little bit more thoughtful.

So, what we've actually been focused on is let us develop, let us really understand what does it take to get approval and reimbursement in Europe? What does it take to get approval and reimbursement in Japan? And we are very close to having a full plan set in place.

And we've started to have conversations with those companies that have expressed interest. And then at the time where we feel like we have the knowledge and the path forward laid out, then we will also make some proactive contacts with companies in those regions.

So, I'll just say we are looking at potentially a company that has both Europe and Japan, and China; and so one ex-U.S. partner outside of Israel, obviously. So, that would be ideal, I think, in a lot of ways. But you want to make sure that it's a partner that will successful in those markets.

If that doesn't work out, then we'll probably look at potentially Europe, Japan, and maybe China, because obviously China is very unique. And again, while we have had some preliminary conversations, we just are finishing up exactly what will it take to be successful in those markets.

We can't negotiate the best deal for our company and for our shareholders with our partners and until we know exactly what it would take. And that's kind of what we've been focused on. So we've had -- we've engaged experts in this area. I, obviously, have run global businesses; we have other people in the company that have a lot of experience in areas.

Our Chief Business Officer lived in China for several years, so she has personal relationships. So, we've really leveraged the knowledge and the know-how that we have to make sure that when we do start to have those conversations, that we're putting ourselves in the best situation possible. So, those will start in the fall.

And I think that we'll be able to give an updated over the next, I would say, two months on exactly what that looks like, like what is it going to take. And I've said this before, Japan; you always have to do a bridging study. They want to see the medicine in their patients; it's more of a safety than an efficacy.

But we know that we can get reimbursement there. Europe, it was about understanding what are the possibilities of us getting a decent reimbursement, and not being compared to generic mitomycin and we think we have a path forward there. So, now that we feel like we have more of an understanding of exactly what it takes, we'll start those conversations.

So, sorry, that was a long-winded answer to your question, Ram..

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

Well, what we've been doing over the last two months is actually having those conversations with some of the payers. So, we have some experts that we've been working with. So that was our decision that we felt like we wanted to understand, right. So, some of the partners have said they have their perspective on what that would look like.

And you want somebody who has that capability. In Europe, that's probably the number one capability you need, is market access, can they get in there, can they negotiate a good deal with the government. So, that -- we'll be looking for that capability.

But I think we're in a position now where we have enough information, enough knowledge that we'll be able to start those discussions..

Okay.

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

Well, I would be remiss if I said there it would have no impact. I mean I think that we've seen just things change the last couple of weeks, they're changing daily. Jeff can comment, but accounts that maybe were going to open access are now shutting down access.

I had my own personal experience with the healthcare system where a family member couldn't even get a -- couldn't get a hospital bed because of COVID. And so, to say that it won't have any impact, I don't know that, right. We are - we continue to see good access. We do see -- we still see restrictions, right.

And so we - it's a day-by-day, week-by-week thing.

As far as ATLAS is concerned we feel like, because we have a lot of sites up and running and different areas around the world, that if we need to pivot and get more patients in one area versus others, that we can actually do that, which is one of the reasons that we actually wanted to have more sites.

And as you heard, we've got the 100 sites activated. So, to be in that position, I think, will help us from an ATLAS standpoint. I don't think that the Delta variant or COVID, at this point, would shut down our business, if that makes sense. So, I don't think we're in a position where we're not going to be able to continue to be successful.

So, it might impact the ramp, but I don't think it's going to impact -- some patients are still going to be - need to. And I think patients are more comfortable now, especially those that have been vaccinated are more comfortable going out there. And Jeff talked about the nephrostomy tube.

I personally am very excited about that administration, and think that if things continue to shut down and the hospitals aren't able to do elective surgeries or elective procedures, then you may see an increase in nephrostomy tube.

And we'll make sure that we are in a position to be able to support physician offices, to be able to do that route of administration..

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

No, that's okay.

Mark, do you just want to comment on that? I don't remember if we said anything bout time?.

Yes, we actually haven't. We're moving along. We're expecting data at the end of the year. So, I suspect that we'll decide to talk about that after the end of the year. So, I guess that's probably what the -- [multiple speakers]..

Yes, [multiple speakers] next year, yes..

Great, thank you..

Thanks, Ram..

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

Hey, guys. Congrats on the good quarter.

Just wanted to follow up in terms of digging a little bit more to the prior question in terms of how have, I guess, third quarter sales and new starts been shaping versus the second quarter? And have you been able to maintain the momentum that you saw in the second quarter in the third quarter, given the changing dynamics here now with the Delta variant? And then another question with respect to the nephrostomy tube study data, I guess maybe more for Mark.

How will this, do you think, impact use and uptake of Jelmyto going forward, and not only in the context of the pandemic, but also further out after we're kind of out of that range?.

Yes, Matt, Liz. We're not really providing month-over-month or month-to-month data around patients. I would say we continue to see patient enrollment forms come in. We continue to see new patients being dosed. So, we continue to see growth in the numbers that Jeff talked about.

So, we expect that we will continue to see adoption increase over the next few months, and beyond. So, we remain bullish about that.

But Jeff, maybe you can just comment on what you're seeing out in the field around physicians and around the reps, and the representatives and what they're able to do? I think that would be very helpful for how things are going, and turn it over to Mark to answer the question on the study.

So, Jeff?.

Yes, thanks. It's exactly what you said, so reps are going deeper into accounts where continue to see growth, and will continue to see that. And so, as I said earlier, they've got a tool now to help even expand to the full indication, excited to have that. And I think AUA; it'll be good timing to finish the year strong as well, first live meeting.

So, Mark?.

Yes. And, Matt, just to make sure I'm answering the right question. The nephrostomy tube issue, I think, is what you're asking about.

And it's an interesting byproduct of the launch, because [indiscernible], there's no -- the pivotal study was done entirely in the retrograde manner, meaning that the drug was instilled into the kidney through a catheter placed through the urethra into the bladder, and then into the kidney.

The practitioners have started placing a nephrostomy tube which, as many know, is a tube placed directly through the skin of the back into the kidney, which provides direct access without the need for lower urinary tract instrumentation in order to deliver Jelmyto.

And what we're hearing anecdotally is that it is a very acceptable method for delivering the drug, both from a practitioner and also from a patient perspective. I think there was initial worry that the nephrostomy tube would be viewed by patients as an encumbrance and an inconvenience.

As it turns out, it actually is both convenient, well tolerated, and very significantly simplifies the office workflow. Imagine a patient coming into the office, pulling up their shirt, exposing the port, effectively, the tube access into the kidney; the practitioner instills the drug, and the patient goes home.

So, we're hearing, anecdotally that there are a lot of advantages, both from a patient acceptance as well as a workflow perspective using nephrostomy tubes. We know that there are investigators in the field now studying this. And we are excited actually to see some presentations and papers in the coming year about this.

So like I said, that if what we're hearing anecdotally continues, that there will be a significant uptake of this mode of delivery, because it has a lot of advantages both in terms of, again, in-office workflow as well as patient acceptability..

Okay, that's very helpful. Thanks for the added detail. And one last question, I guess, given the success that you've been having.

Any plans to change your commercial footprint at this point?.

No, not really. We may, we're adding a couple of clinical nurse educators, because we want to make sure that we -- one of the things that's been very helpful is that the success and the support that we provided at the physician offices.

So, other than a couple of clinical nurse educators who need to be there the first or second time they do the installation, the footprint should stay the same..

Okay, very good. Thanks for taking the questions..

Thank you, Matt..

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.

Just a couple from us, maybe starting with your comments on the community setting, could you maybe just elaborate a little more if this is just more sort of early trialing by practitioners in the community or this is more reflective of Jeff and team beginning their sort of next wave of tiering and target account penetration here?.

Jeff?.

Yes. So, I would say it's the next wave. I think you're starting to see community; they're obviously looking to bring back revenue. There's been a big push to bring back revenue in the surgery center.

And so, you're starting to see -- and as I've said this -- you know, as well, they like the J Code, they don't like having the permanent code, and there's just a little more level of comfort.

And so those doctors that were diagnosing in their -- in the community and going to the hospital are now saying, "Okay, I'm going to diagnose in the community and this do this in my surgery center." So -- and to your point, we expected, out of the gate, to be in the hospital.

And as we grow, we're going to continue to grow -- we'll continue to grow on the hospital, but you're going to start to see more of that into the community..

Okay, thanks for that color. Then one on the pipeline side for us, just with regard to 301, I know you mentioned that the -- to an earlier question, that the non-human primate work would be completed around year-end or so. But your comment on -- that you see it as a [commoditorial] [Ph] asset for additional solid tumor types.

Have you identified; I guess, at this point, based on sort of analogues in the market, where directionally you would go? And then would you pursue this additional combination development as either investigator-sponsored trials or would these be primarily a company directed -- company sponsored, excuse me?.

Yes, great question. I think that we are just starting to look to see other areas. And I think it would be both, right. We have investigators that are interested in potentially seeing it used in certain ways, and we would do that.

And we also, when we see other assets out in the marketplace that are being studied, where we think, "Oh wow, that might be a good opportunity for us to do a combination," then we may do some partnerships with other companies. So, I think we're looking at it in the continuum of different areas.

But we don't have anything specific yet; this is just as we started to work with and the feedback that we're getting so far with 301. Anti-CTLA-4 is well known -- the efficacy is well known. So, our ability to deliver it locally, we believe, has advantages, both from an efficacy and safety standpoint.

And so, if we're able to do that in combination, we think there's a lot of opportunity there..

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

Thanks. Great, thank you..

Thank you. 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, as I mentioned before, 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, like I said, work. And we know now that we have the flexibility and the adaptability to adapt to whatever situation there is, because we are committed to ensuring that patients have access to Jelmyto. So, again, thanks for your interest in our company. We look forward to more dialogue. And, 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..