Thank you for standing by and welcome to the UroGen Pharma Second Quarter 2020 Financial Results and Business Update Conference Call. At this time, all participants in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator instructions] Please be advised that today's conference is being recorded.

[Operator instructions] I would not like to hand the conference over to your speaker today to Peter Pfreundschuh, CFO. Thank you. Please go ahead..

Thank you, operator. Good morning, everyone and welcome to UroGen Pharma's second quarter 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 ended June 30th 2020.

The press release can be accessed on the Investor's portion of our website at investors.urogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer and Jeff Bova, Chief Commercial Officer. Please note that we are conducting our call today from different locations.

So, we appreciate your patience and understanding should we have any technical difficulties. In just a minute, I will turn things over to Liz who will provide a summary of our recent corporate developments. Mark will then share a clinical development update, and Jeff will discuss our commercial progress made since launching Jelmyto in June.

Following Jeff, I will provide an overview of our financial highlights for the second quarter before opening up the call for questions. As a reminder, during today's call, we will be making forward-looking statements.

Various remarks that we make during this call about the company's future expectations, plans and prospects, constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.

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 UroGen Pharma's quarterly report on Form 10-Q filed with the SEC this morning and other filings that UroGen Pharma makes with the SEC from time-to-time, as well as any negative effects on UroGen's business as well as commercialization and product development plans caused by or associated with COVID-19 pandemic to the extent not disclosed previously.

We encourage all investors to read the company's quarterly report on Form 10-Q and the company's other SEC filings. These documents are available under the SEC Filings section of the Investors page of UroGen's website at investors.urogen.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, Peter. Good morning, everyone, and thank you for joining us today. I'm delighted to be speaking with you representing a company that has successfully transitioned from a clinical to commercial stage biopharmaceutical company.

Since the June 1 launch of Jelmyto for patients with low-grade, upper track urothelial cancer or low-grade UTUC, we have been extremely pleased with the response from both physicians and patients.

We are very pleased that as of June 30, 20 doses have been administered to patients and thanks to the preparedness of our team, we've been able to meet every request for product and support. Jeff will provide more details on the launch, but interest has been significant and we continue to see increased demand despite the challenging environment.

I would like to recognize and thank Jeff and the entire commercial team as they have proven their commitment to bringing this breakthrough therapy to patients.

Further supporting our launch efforts have been the publication of results from the pivotal Phase 3 OLYMPUS trial of Jelmyto and the Lancet Oncology and in a supplement to the April 2020 issue of The Journal of Urology. This data was also the focus of a virtual presentation at the 2020 American Urological Association Annual Meeting in mid-May.

Additionally, Dr. Karim Chamie from UCLA highlighted the benefits of Jelmyto as a kidney-sparing option for low-grade UTUC and reviewed the clinical profile and safety data as part of theater during the AUA live meeting at the end of June.

The publication and presentation of OLYMPUS data continued to underscore why Jelmyto is important to patients as the first and only approved nonsurgical chemo-ablative treatment for those with this rare and difficult to treat disease.

The OLYMPUS study has now completed and we’ve submitted an updated label to the FDA including the final safety and efficacy data. While there's no mandated time line for review, we believe the FDA will approve an updated label in the second half of 2020. It's important to note that the final data is consistent with our previous results.

So we don't anticipate significant changes to our label. In addition to the approval and launch of our first therapy, we continue to advance key initiatives designed to build a long-term growth company. This includes the presentation of updated data from the Phase 2 OPTIMA trial of UGN-102 at the AUA Annual Meeting in May.

No drugs are currently approved by the FDA as first-line treatment for low grade intermediate risk non-muscle invasive bladder cancer.

This is a sizable opportunity with over 80,000 addressable patients in the US alone and we believe UGN-102 has a potential to be the first FDA approved therapy in this setting and an important nonsurgical treatment alternative for this difficult-to-treat patient population.

Mark will share our latest update to the data as of July but we remain very encouraged by the positive complete response in 12 months durability data. This data combined with the data from OLYMPUS durability data.

This data, combined with the data from OLYMPUS for low-grade UTUC, supports the potential of UGN-102 to have a profound impact on patients who deserve better options. We remain on track to share the final CR and durability data from the OPTIMA II trial by year-end, and we will initiate the pivotal Phase 3 clinical study.

Mark will share the details of the trial design including patient numbers and timing which are in line with our previous discussions and expectations. Additionally, our UGN-302 program has generated a lot of excitement internally and externally and it has the potential to transform how high-grade non-muscle invasive bladder cancer is treated.

UGN-302 is a combination of UGN-201, our TLR7/8 agonist, and zalifrelimab, the anti-CTLA-4 antibody we licensed from Agenus. There remains a significant unmet need in these patients despite recent approval as the data supporting these approvals reflects only incremental improvement and the continued need for treatment post BCG.

Lastly, we have a strong balance sheet and are pleased with our financial outperformance in Q2. Peter will discuss in more detail, but our cash position allows for our current operations well into 2022, and we have no need for additional capital at this time.

We continue to search for new medicines and partnerships to ensure a sustainable growth, but early successes demonstrate the potential of our medicines and strengthen our belief that we can achieve peak revenue of more than $1 billion annually from our current portfolio.

With that, I'll turn the call over to Mark to discuss our recent clinical update.

Mark?.

Thank you, Liz. We are very encouraged by the progress we’ve made and equally excited about what’s to come. I can tell you first hand that the exciting in neurologic community about our recent advances is palpable.

As a practicing neurologist, I'm particularly encouraged by the interest from my medical colleagues regarding the recent launch of Jelmyto and how they can incorporate this paradigm-shifting therapy into their practices. We had two virtual presentations at the AUA Annual Meeting in May.

The first featured data from the Jelmyto pivotal OLYMPUS trial in patients with low-grade UTUC. The data in the presentation also published in Lancet Oncology demonstrated that 59% of low-grade UTUC patients treated with Jelmyto achieved a complete response.

Based on interim data, durability at 12 months was estimated to be 84% by Kaplan-Meier analysis and median duration of response was not reached. Overall, the most frequently reported adverse events were ureteric stenosis, urinary tract infection, hematuria, flank pain, and nausea.

We also shared interim data from the Phase 2b OPTIMA II trial of UGN-102 in patients with low-grade, intermediate-risk, non-muscle invasive bladder cancer. These data were also published as a supplement to the April 2020 issue of the Journal of Urology.

We are pleased to share updated results as of June 19, 2020 which are consistent with our previous reports showing that 65% or 41 out of 63 patients treated with UGN-102 achieved a complete response three months after the start of therapy.

In the subset of patients, the interim Kaplan-Meier analysis shows a 72.4% estimated duration of response to 12 months. This analysis includes only patients who are present for evaluation at each time point. Follow up of these patients will continue until all patients have reached the 12-month timepoint.

The most common adverse events, greater than 10% were reported as mild to moderate and include dysuria, hematuria, urinary frequency, fatigue, urgency and urinary tract infection. This data continue to validate our hypothesis that increased dwell time significantly improves the effectiveness of intravesical therapy.

But UTUC and non-muscle invasive bladder cancer are treated by repetitive surgical intervention, which carries associated risks in an elderly population.

Much like Jelmyto, UGN-102 may have the potential to fundamentally change the way low-grade, intermediate risk non-muscle invasive bladder cancer is treated and help patients avoid recurrence of their cancer and repetitive surgeries. This time, in a much larger patient population.

We have agreed to the design elements of our Phase 3 study with the FDA and are finalizing the protocol. The study will be a randomized, controlled trial in approximately 600 patients of UGN-102 with or without you TURBT versus TURBT alone in patients with low-grade, non-muscle invasive bladder cancer and intermediate risk of occurrence.

Patients will be randomized to either UGN-102 plus or minus TURBT or TURBT alone. At the three-month timepoint, patients will be assessed for response. Patients who have demonstrated a complete response to either UGN-102 or TURBT will continue for long-term follow-up. Patients who demonstrate a recurrence in either arm will undergo a TURBT.

Based on previous Phase 2 data generated in this population, we believe the majority of patients treated with UGN-102 will not require a TURBT at three months. The primary endpoint of the study is disease-free survival and the study is designed to conclude superiority and who are non-inferiority.

We expect completion of the study within approximately three years, with the potential to stop early and prespecified interim analyses. We are excited by the robustness of the study design, which is important given the potential UGN-102 has to significantly disrupt the current treatment paradigm.

We want to ensure patients have access as soon as possible. And the head-to-head comparison is expected to generate data demonstrating the value of treating patients with UGN-102 versus repetitive surgical intervention.

Before I turn things over to Jeff, I want to provide a little more detail on UGN-302, a combination of UGN-201 which is our TLR 7 agonist, as a monotherapy and zalifrelimab, anti-CTLA4 antibody which we are developing in high-grade, non-muscle invasive bladder cancer.

Patients with this disease are at higher risk for rapid progression with an increased risk of developing a life threatening illness. Since the disease primarily impacts people in their 60s and 70s, often with other comorbidities, non-surgical treatment options are of vital importance.

The current standard of care for high-grade, non-muscle mass of bladder cancer is transurethral resection of bladder tumor or TURBT, in addition to BCG.

Those who do not respond to BCG then receive alternative intravesical therapies, enroll in a clinical trial or undergo radical cystectomy, which is a complex surgery involving bladder removal and urinary tract reconstruction using a segment of the intestinal tract.

This operation is associated with all of the typical risks of a major surgery and specific risks such as dehydration, electrolyte abnormalities, urinary tract infection, bowel obstruction and ureter blockage urinary tract infection, bowel obstruction, and ureter blockage.

A cystectomy is associated with high rates of complication including gastrointestinal dysfunction, deep vein thrombosis, heart attacks and death. The hypothesis that the preclinical team has been working on is it combinatorial immunotherapy is feasible and meaningful when applied locally which is a very novel idea.

Delivering the combination intravesically may sign step -- systemic side effects and adverse events associated with systemic immunotherapy.

What we found is that a combination of UGN-201 with an anti-CTLA-4for antibody resulting smaller tumors and better survival in mice and some changes of immunological markers such as decreased T regulatory cells and increased CD8 to T-reg ratios in arm [ph] model.

We think these data support advancing this program into human trials as this may represent a novel approach to managing high grade disease that has otherwise failed therapy with contemporary standards of care. As Liz mentioned, this program has generated considerable interest based on its potential to dramatically change how we treat this disease.

I'd like to now turn the call over to Jeff..

Thank you, Mark. I'm excited to speak with you today on the heels of our June 1, Jelmyto launch which is to the head of our timing and guidance to the street. As Liz shared, interested Jelmyto has been significant and demand continued to increase despite the challenging environment thanks to the efforts of our entire team.

We booked almost $400,000 in net sales as of June 30. We're definitely off to a solid start and I remain optimistic that we can sustain our early momentum moving forward. While patient access is challenging in today's environment due to COVID-19, we are seeing patients able to be treated.

Some of our field personnel have been limited in their live interactions with physicians especially in areas of the country where infection rates are on the rise. But we have increased our investment in digital tools and are finding ATPs open to engaging with us virtually.

Importantly, while some states are not allowing certain surgical procedures including RNUs, Jelmyto can be instilled in the clinic. And when patients are treated in a hospital setting, it’s an outpatient procedure typically under local anesthesia. In fact, most installations to-date has been under local anesthesia.

Thanks to this flexibility, we haven't heard about procedures being canceled or delayed due to COVID-19 and we've been able to treat patients in states hit disproportionately hard by the virus including California and New Jersey which is where our first patient was treated in June.

While we are obviously early in our launch, we've seen many positive indicators. To date, we've activated roughly 100 sites which means they have completed their internal processes and have or are ready to treat patients. This includes sites who participated in the Phase 3 OLYMPUS trial. We have also had two accounts treat more than one patient.

This is an important metric to show that the process we have put in place has been smooth and the account is identifying other patients who could benefit from the treatment with Jelmyto. To date, roughly 75% of treating physicians were not part of our Phase 3 trial.

This isn't surprising given UTUC is a disease predominantly diagnosed in the community. But it underscores the fact that we have been focused on the right targets and we're able to generate broad awareness of Jelmyto amongst community urologists. It also validates our mixing strategy and the utility of the partnership we established with Option Care.

From a coding and reimbursement perspective, we have committed significant resources to working with our top accounts and institutional accounts. As a result, multiple treatments have already been successfully reimbursed. Additionally, thanks to our market access team, we were able to complete both our C and J code applications.

We are on track to receive our C code in September, which means it will go into effect in October and our J code in January of next year. So, again we are definitely off to a solid start and we feel we are well-positioned to build on the momentum we generated since our June 1 launch.

Before I turn things over to Peter, I want to recognize and applaud the efforts of health care providers and staff who have worked collaboratively with us to bring Jelmyto to patients.

It's certainly been a challenging couple of months but our team has overcome every obstacle and remain committed to do so whatever is necessary to address the unmet need in the urologic community with this novel and effective kidney sparing treatment option.

The work we are doing now will not only help us to achieve our short-term goals, but will build a foundation for future success with UGN-102 and the other opportunities in our pipeline. And with that, I'd like to turn the call over to Peter who will discuss financials..

Thank you, Jeff. And good morning, everyone, on today's call. Urogen recorded net product sales of Jelmyto for the second quarter of 2020 of approximately $371,500 reflecting sales only during the month of June 2020. Associated costs of revenues were approximately $48,200 including certain onetime initial cost.

In periods prior to receiving FDA approval for Jelmyto, the company to recognized inventory and relate costs associated with the manufacturing of Jelmyto as research and development Jelmyto as research and development expenses.

We expect this to continue to impact our cost of revenues during the fourth quarter of 2021 as we produce Jelmyto at costs reflecting the full cost of manufacturing and as we deplete these inventories that we had expensed prior to receiving FDA approval.

For the second quarter ended June 30, 2020, we recorded a net loss of $31.3 million or $1.44 per share. This compares to a net loss of approximately $22.5 million or $1.08 per share for the same period in 2019.

The net loss for the second quarter ended June 30, 2020 includes $7.1 million in noncash share-based compensation expense as compared to $7.2 million for the same period in 2019. For the six months ended June 30, 2020, we recorded a net loss of $69.1 million or $3.22 per share.

This compares to a net loss of approximately $43.9 million or $2.19 per share for the same period in 2019. The net loss for the six months ended June 30, 2020 includes $14.7 million in noncash share-based compensation expense as compared to $14.7 million for the same period in 2019.

Research and development expenses for the second quarter ended June 30, 2020 were $8.1 million as compared to $10 million for the same period in 2019.

Research and development expenses also include $1.6 million of noncash share-based compensation expense with the second quarter ended June 30, 2020 as compared to $2 million for the same period in 2019.

The decrease in research and development expenses from 2019 to 2020 is mainly attributable to the completion of the Phase 3 clinical trials and regulatory activity for UGN-101, and decreased activity related to UGN-102 Phase 2 clinical trials partially offset by an increase of head count, the related costs in anticipation of UGN-102 Phase 3 clinical trials.

Research and development expenses for the six months ended June 30, 2020 were $24.7 million as compared to $19.7 million for the same period in 2019. Research and development expenses also includes $3.5 million of noncash share-based compensation expense for the six months ended June 30, 2020 as compared to $4.3 million for the same period in 2019.

In addition to the above, the increase in research and development expenses for the six months ended June 30 from 2019 to 2020 was mainly attributable to a onetime payment of $6.6 million to online the company's obligation to the Israeli Innovation Authority during the first quarter of 2020.

Sales and marketing expenses for the second quarter ended June 30, 2020 were $12.8 million as compared to $3.2 million for the same period in 2019. Sales and marketing expenses include $1.2 million of non-cash share-based compensation expense to the second quarter ended June 30, 2020, as compared to $0.5 million for the same period in 2019.

The increase in selling and expenses resulted from the increased costs and activities related to the launch of Jelmyto including headcount and related costs associated with our sales force. Selling and marketing expenses for the six months ended June 30, 2020, were $23.4 million compared to $5.8 million for the same period in 2019.

Selling and marketing expenses include $2.3 million of non-cash share-based compensation expense for the six months ended June 30, 2020, as compared to $0.9 million for the same period in 2019.

The increase in selling and marketing expenses resulted from increased costs and activities related to the launch of Jelmyto including headcount and related costs associated with our sales force. General and administrative expenses for the second quarter ended June 30, 2020, were $11.3 million as compared to $10.6 million for the same period in 2019.

General and administrative expenses include $4.3 million of non-cash share-based compensation expense for the second quarter ended June 30, 2020, as compared to $4.7 million for the same period in 2019.

The increase in general and administrative expenses from 2019 to 2020 resulted primarily from an increase in cost as part of the build-out of our company with commercialization of our first products and consulting and other outside fees.

General and administrative expenses for the six months ended June 30, 2020 were $22.6 million as compared to $20.7 million for the same period in 2019. General and administrative expenses include $8.9 million on noncash share-based compensation expense for the six months ended June 30, 2020, as compared to $9.4 million for the same period in 2019.

The increase in general and administrative expenses from 2019 to 2020 resulted primarily from an increase in cost as part of the build-out of the company for the commercialization of our first product and consulting and other outside fees. We closed the second quarter of 2020 with $151.6 million in cash, cash equivalents and marketable securities.

This excludes restricted cash. Our current balance sheet supports the company well into 2022 as we ramp the commercialization of Jelmyto and start to see offsetting operating margin and cash inflows from commercial sales.

This will allow us to vigorously advance the clinical development of UGN-102 as well as other clinical programs already in the pipeline. With that operator, I would like to turn the call over for questions..

Thank you, sir. [Operator Instructions] Our first question comes from the line of Ram Selvaraju from H.C. Wainwright. Please go ahead..

Hi. This is Blair [ph] on for Ram. A couple of questions from me.

First, can you talk a little bit more about how COVID-19 has affected the launch of Jelmyto? And what kind of strategies are you employing to mitigate this impact? Do you anticipate a more normalized commercial environment to materialize later on? And how is your virtual platform been functioning thus far and what attendance there might..

I would just make a couple of comments and turn it over the Jeff because he can give you more specifics around it. I think as Jeff mentioned earlier, we have not seen an issue when patients actually get scheduled or them coming in to have their medicine.

And Jeff also mentioned that in some states, they're not really allowing face-to-face interaction with a representative. And so, that's why a lot of what we're doing is virtual. But I do want to comment that we also have, as we've talked about before, nurse educators and medical science liaisons.

And they are able to go in and educate doctors and answer any questions that they have. My personal opinion, and we have no data that sort of shows this, but if you look at read overall, you are seeing sort of a, I would say, reduced patient engagement with physicians overall. Not just for us but for everyone.

I will tell you that despite any of that, we are well ahead of where we expected to be right now. So, we don't really see it impacting specifically right now. I think the impact of COVID will be yet to be determined. And what I mean by that is it depends on what happens over the next few months.

Because like I said, you can read everywhere that they’ll show that cancer diagnosis and treatment is down over 40%; but to Jeff’s point, we haven’t seen that specifically but we are seeing some of the limited engagement because of that.

So, I think, and Jeff can talk to you more about the strategies to impact, I think we're just going to have -- it's a fluid situation.

But despite all of that, I think it's really important for you to know that the number of patients we have in the pipeline and the number of patients that we treated so far is well above where we expect it to be right now. So, I think it's still something we need to be very cognizant of. And I'll turn it over to Jeff to talk more about our strategy.

So, Jeff?.

Sure. Thanks, Liz. So, what we’ve done is we’ve increased our resources and investment in our digital platform as well as our non-personnel promotion.

So, I think everyone got to see the virtual AUA that was successfully rolled out continues to get what we can measure of click-throughs, how long folks stay on the site, continue to be well above industry average. And as Liz said, I mean, it is a fluid situation. Actually hospitals -- a lot of hospitals can't perform an RNU. It's an overnight surgery.

I talked to a couple of physicians where that's a surgery that they cannot perform right now. And so Jelmyto becomes another option because, as we said, it can be given in an outpatient setting under a local.

But those are some of the -- certainly the increase just to keep the awareness high in major periodicals that urologists read, we're increasing our investment there.

And really anything that's holding -- the things that are we're working through are typically the internal processes of our customers whether that's an informal formulary review and whether that’s making sure we sit down and meet with billing and coding. We haven't had delays due to COVID-19..

Okay. Great.

And could you talk a little bit about the impact of the inclusion of the NCCN Clinical Practice Guidelines for Jelmyto?.

Sure. First of all, it's a record inclusion. I think NCCN also recognizes the unmet need in this area. And so they included it quickly in their guidelines. We have -- we'll work with NCCN to communicate that. That'll be a piece we can promote that the inclusion of the guidelines.

Any sort of inclusion like this is certainly something that will help the brand that will help the promotional team go out with and so it's been a positive and even more so that it came, you know, very soon after launch..

I think the other only comment about the NCCN Guidelines, as you know a lot of payers follow NCCN Guidelines and you know and so that also helps us when we think about any reimbursement as we go forward. So, thanks, Blair..

Okay. Great. And if I could just squeeze in one more real quick.

Do you anticipate any impediments to enrollment with UGN-102 the pivotal study due to COVID-19?.

We actually do not at this point and mainly because we have increased our number of sites outside of the US and in some other Eastern European markets where we don't see -- where they're not seeing the COVID or the delays because of that.

So, we expect it may have some delay in the US but we've already planned for that and don't expect it to impact our enrollment at all..

Thank you. Our next question comes from Derek Archila from Stifel. Please go ahead..

Hey, thanks, guys. This is [indiscernible] for Derek. Thanks for taking my call. I'm just wondering if you guys did comment on the number of patients who were actually using the drug right now. And then how many docs are actually doing it too and then does this varied by I guess -- vary by parts of the country. And that's it for us. Thanks..

Yeah. It’s Liz. I'm -- the number that we had talked about the 20 doses, I will share with you that -- that was eight patients. In June, we -- going forward, we're not going to every month or every quarter give all of the patient numbers as we start to get into our revenue generation.

But I think it's important for you to know that that and the reason I share that is because it shows that we've gotten both new patient as well as repeat patients. So, as you know, as we go into the months and weeks, these patients are getting kicked to weekly doses. So, it's important that they continue to get their all six doses.

So, we do have patients in that June time frame that got one. We've got patients that got multiple doses. I'll let Jeff talk about the physicians that are engaged. We're just pleased and like I said, we can't share numbers after Q2 but I'll just remark that we're continuing to see progress and happy with our progress as we go into like Q3.

So, Jeff, do you just want to comment about physician without giving too much specific information that that's in this early stage?.

Yeah. We’ve had a growing number of interests in physicians both in community and academic settings. And to your question around do we have sort of pockets, we don’t, I’m not saying that -- I can’t say. We’ve had patients on California. Our first patient was in New Jersey.

We just recently had a patient in Long Island which as you know is the hard-hit area. We also had patients in Missouri. And so, we’re not seeing sort of geographical impact with regards to patient access. So, hopefully that helps..

Thank you. Our next question comes from the line of Boris Peaker from Cowen. Please go ahead..

Good morning. For Jelmyto, I'm just curious, do you anticipate a stronger uptake in the academic or community settings? And if you can also expand on what are some of the economic implications for using the drug in both of these settings..

Yeah.

Jeff, why don’t you answer that?.

Sure. So, we believe that most of this and it’s proven to be true in the patients that we've got today, most of the diagnoses occurs in the community. We think that that will be probably 75% of patients. Having said that, some of the patients that we've received were part of our -- went to our Phase 3 physicians, they were part of OLYMPUS.

So, those are, as you know, big referral centers. They’ll continue to be that. So, they'll be very important for Jelmyto as well. But as we stated, the majority of patients are diagnosed in the community and depending on where the urologist does his or her surgery, that will be dependent on where they go to actually administer the question.

And with regards to -- from a financial standpoint, this is a buy-and-bill drug. So part B is in void. So, physicians now are lining up their claims submission. They will fill out the appropriate forms to be reimbursed buy-and-bill. Reimbursement will -- it will be consistent until we get an established ASP.

And depending on the MAC carrier, there are 9 to 10 MACs that cover Medicare throughout the nation. They'll reimburse either 95% of AWP or WAAC plus model until we establish an ASP which we expect the ASP to be in January. But yeah, there’s a -- they certainly -- they understand buy-and-bill from drugs like PROVENGE and Xofigo.

So, this is nothing new to them which is -- which we're fortunate that we don't have the kind of face that hurdle. They’re very familiar with the buy-and-bill landscape..

Got you.

And my last question what's the status of the European update? When should we be hearing from there?.

Yeah. We just recently engaged a small firm there that have two principles that actually were part of the EMA and we're working through that as we've said before. So, we expect to have a plan in the next couple of months. As we've stated before, the issue isn't so much getting an approval. It’s really getting reimbursement.

So, we've got to work through countries like Germany and France and we've got upcoming meetings around what would it actually take to get good reimbursement there because they use the comparator model. That’s a challenging situation for UGN-101.

For UGN-101 with the head-to-head in UGN-102, we won’t have that issue, but we do want to make sure that we have it available. We also have engaged in Japan, the regulatory authorities. And so, we’re working through those and I think we’ll see something in the next three to four months, we'll have a more clear plan.

When do we need to do another study or what exactly we would need to commercialize in those geographies..

Thank you. Our next question comes from the line of Leland Gershell from Oppenheimer. Please go ahead..

Hey good morning. Thanks for taking my questions. First question on commercial, I guess for Jeff, but also maybe for Mark as well. We've had some recent publications in the literature that reviewed the data from past studies in different tumors with regard to how long patients can go without treatment and what the outcomes would be.

As we’re in the COVID-19, as urologists sort of triage those patients who are more important to see first versus later in terms of intervention.

I want to ask about with low-grade UTUC, to what extent do you think that urologists will defer therapy, even though you haven't seen evidence perhaps of that to prioritize treatment of patients who have more aggressive or later stage disease.

At the same time with hospitals not -- perhaps some hospitals not doing RNUs, urologist may have more office time to do those types of in-office procedures for earlier stage cancers. How should we think about kind of those two push-pull factors as we get through the pandemic? And then I've got a couple of R&D questions. Thanks..

Yeah. So, Jeff, why don’t you start first and then Mark can give his perspective from a physician's standpoint and then answer your R&D questions. So, Jeff..

Sure. So, what we've heard is just like everyone is trying to find solutions and -- to the COVID-19, our physicians are doing that as well.

And so, you know, I'll give you an example where a patient didn't want to go to the hospital and so the physician actually sought out some surgery centers to where the patient would feel more comfortable because as the citizen said to me, and I'll let Mark allude to, how long patients would wait.

But the patients are reminded perhaps every day that their cancer is back. There is significant -- there can be significant amount of blood and urine. And so their anxiety levels, as you can imagine, go up as there -- as the time before any sort of treatment occurs. So, we're finding physicians are working with their patients.

They're working to make their patients feel comfortable in areas where either hospital access is not there right now. They're prioritizing other patients or just the patient as I alluded to, the patient in this case is uncomfortable going to a hospital.

Mark, you want to comment?.

Yeah. Leland, it's a great question and I think as you might well anticipate, everyone is struggling. We're all struggling with huge backlogs of patients who were delayed because of the limitations on the availability of elective surgery time for patients just like this. So, we're doing all the things that Jeff just described.

But I do think actually the circumstances provide an opportunity for physicians to think creatively about how to treat patients with low-grade disease.

So, in a very paradoxical way, COVID is providing an interesting opportunity for physicians to really think through alternative therapies for patients with low-grade disease and obviously Jelmyto is such an alternative.

So, in a paradoxical way, it may actually push physicians and patients to consider this therapy more readily than they might otherwise have..

All right. Thank you. And then on the R&D side, one question on Jelmyto. I believe you had a study -- either it was rolling bits or maybe if that's any way you were looking at Jelmyto in the maintenance setting for a longer-term use and/or patients getting back on Jelmyto after initial use if they have recurrence.

I wanted to ask about the status of those data. And also with regard to the upcoming bladder trial, Mark, you’ve mentioned a couple of interim opportunities may be too early or kind of moving advancement into a filing. I wanted to ask if you have any more color around what the bars would be for those interims? Thanks..

Sure. Thanks. So, with respect to maintenance, I think the Lancet article actually gives a very good description of what we and don't know about maintenance.

And what we do know is that most patients in the trial received a dose at least of maintenance therapy, but the application of maintenance across the trial was so individualized as to make it very difficult for us to draw any conclusions about the value of maintenance in this context.

So, that's really the use of maintenance is really left to physician discretion in the context of the use of Jelmyto in the treatment of upper tract [indiscernible] disease. With respect to retreatment, we are contemplating a retreatment program because obviously that would be very valuable to patients who had a good response and then relapse.

So, we would want to study the utility of retreatment and plan to do that. We had a retreatment trial open but unfortunately we didn’t have any patients to treat. So, we’re going to reinitiate that program as we continue to follow patients in Jelmyto. At least we can continue to follow these patients for up to three years for additional information.

And then, finally, with respect to the bladder program and the bladder Phase 3, we haven't really disclosed what the bars would be for early -- earlier closure or reevaluation of the data but, you know, it's obviously part of the design.

And as we initiate the trial and start accumulate information, if there are exciting updates, I'm sure we'll be sharing them with you but we haven't specifically talked about that yet..

Great. Thanks for answering my questions..

Thank you. Our next question comes from Paul Choi from Goldman Sachs. Please go ahead..

Hi. Thank you and good morning, everyone, and congrats on all the progress. Two pipeline questions for me if I could. First on UGN-102 o in the plan Phase 3 that's going to start later this year.

Can you maybe just clarify for us just in terms of potential patient stratification, how you're -- if any you’re going to include with regard to risk factors and or prior target experience or may naive patients. And then I had a follow-up question with that..

Mark, you want to go ahead and answer that?.

Yeah. Sure. Paul, thank you. So, a great question. This is in our Phase 2 study. As you know, the study including both patients with new disease, patients who had not previously been treated as well as patients who have recurred.

And in fact, we know that the majority of patients in the Phase 2 trial for patients with the prior history of tumor which is very characteristic, as I’m sure you know, of the group we are focusing on which is the intermediate-risk low-grade population. And just to remind everyone, the intermediate-risk is disease that is low-grade for the most part.

Our study will be low-grade multifocal larger tumors and very importantly, a history of prior treatment for relapsing disease.

So, we will be focusing on exactly the same population that we looked at in the Phase 2 trial and would expect that there might well be a greater number of patients with recurrent disease because that is the nature of the population. They will likely also be patients with de novo disease as well..

Okay. Thanks for that clarification, Mark. And then my second pipeline question is on UGN-302 and specifically with regard to sort of next steps and potential data updates either for UGN-201 or for the zalifrelimab CTLA-4, either when you would might potentially provide either monotherapy or combination updates. Thank you very much..

Paul, thanks. So, we are working in earnest internally as we have announced previously. Our plan is to initiate a human trial as part of this composite program this year and that is still our intention, but we haven't disclosed any additional details about that.

And some of this is, as I think you can well imagine, a series of the complex interactions, the planning of the clinical trial with various preclinical activities as well after including some aspects of formulation.

But our plan is to go ahead with clinical experiments for the end of this year and we're certainly update you as we had more specifics to share..

Thank you very much..

Thank you. Our last question comes from the line of Matt Kaplan from Ladenburg Thalmann. Please go ahead..

Hey, guys. Good morning. Thanks for taking the question. Just wanted to follow up a little bit more on the UGN-102 Phase 3 clinical trial design and timeline.

Mark, maybe perhaps you can give us some or Liz some additional detail in terms of what you expect the primary endpoint would be and the potential timeline for that -- the completion of that study?.

Yeah. I think -- hi, Matt, thanks for joining. Mark gave most of the data in his --during his comment section. But it’s around 600 patients and we expect enrollment to be completed within a year.

As I mentioned during our earlier Q&A, a large portion of the patients will be outside of the US to ensure that our enrollment is not slowed down at all by the pandemic and we're very confident in what we've been doing the work that the development team has been doing.

Under Mark and specifically around getting some accelerated CROs in place and… So, we are well under way to start that study. And so, we feel really good about it.

And as Mark mentioned, we have a couple of pre-specified interim analysis to ensure that at that point in time -- look, it's an event-driven trial, so we can't tell you exactly what the timing will be but our part has a very conservative projection say that it would be completed within three years and that's assuming it goes all the way through.

It had both non-inferiority and superiority and so that’s sort of the data and that’s the kind of guidelines that we'll be following. Again, it's an event-driven study. There'll be a data monitoring committee, you know, who will be taking a look at the data because it's responded to us.

And so I think that sort of gives you all of the information we have at this point. I'm not sure Mark if I missed anything.

Is there something you want to add?.

No. Liz, thanks. No. I think that’s what we can share right now….

Well, I'm sorry. He asked about the endpoint. Yeah. I'm sorry, Mark. He ask about the endpoint if you could talk about that end point would be very….

Oh. Yeah. So, right. So, yeah. So, obviously, in this game with this disease which was managing recurrence show, you know, in any typical setting, we'd be talking about recurrence-free survival for this type of disease. So, I hope that helps with that particular question..

Great. No. Thanks. Thanks, Liz. Thanks, Mark and congrats on the progress..

Thank you. This concludes our Q&A session. At this time, I'd like to turn the call over to Liz Barrett for closing comments. Please go ahead..

Great. Thank you. Thank you, operator. We've made significant progress in 2020. We look forward to continuing the momentum. It has been, as I've mentioned a couple of times on the call, better than we expected even including in the pandemic. We know we've hit the ground running from a commercial standpoint.

We've hit every milestone with a positive outcome. That you used to heard Peter talk about our financial and financial situation. The team is really showing creativity and resilience.

They're launching our first product as we navigate through COVID-19 and I'm really confident in our ability to continue to advance the mission to pioneer new treatments for the improved patient care and specialty cancers and neurologic disease. Our overall fundamentals and long-term prospects remain strong.

Our team continues to work around the clock to make sure that we provide Jelmyto to patients. And who’ve been waiting for better options. And as we make progress with our commercial launch, we advance our pipeline of innovative medicines. We look forward to providing you with further updates.

So, we really appreciate your time and interest in our company and for your continued support. So, operator, you may disconnect at this time. Thank you..

Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Good day..