UroGen Pharma Ltd. (URGN) Q1 2020 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by and welcome to the UroGen Pharma First Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, today's program is being recorded. And now, I'd like to introduce your host for today's program, Kate Bechtold, Senior Director of Investor Relations. Please go ahead.

Thank you, operator. Good morning, everyone and welcome to UroGen Pharma's first 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 March 31, 2020.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; Dr. Mark Schoenberg, Chief Medical Officer; Jeff Bova, Chief Commercial Officer and Peter Pfreundschuh, Chief Financial 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. Liz will provide a summary of our recent corporate developments, Mark will share clinical development and regulatory updates and Jeff will discuss our commercial strategy and updates. Peter will then provide an overview of our financial highlights for the first quarter before we open up the call for questions. As a reminder, during today's call, we will be making certain 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 the 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, Kate. Good morning, everyone and thank you for joining us today. I'm very pleased to be speaking with you so quickly following the FDA approval of our lead product, Jelmyto for the treatment of adult patients with low-grade upper tract urothelial cancer or low-grade UTUC. The events of the first quarter and flawless execution of our team sets the stage for this new chapter in UroGen. We are now officially a commercial stage company and we could not be more excited about the opportunity to bring Jelmyto to patients and physicians. We have received a very positive response from physicians quickly following our approval, demonstrating the high unmet need in this area. As we look forward to the remainder of 2020, we will maintain the momentum from this landmark event and deliver on our commitments to all stakeholders, particularly to our patients. Our top priorities include the flawless execution of our Jelmyto launch and the continued advancement of our portfolio of innovative medicines. While we continue to navigate through global COVID-19 pandemic, our team remains focused on bringing Jelmyto to patients as quickly as possible. Jeff will provide more detail on commercial activities. But I'm pleased to say that as soon as we received approval, we were contacted by physicians for the identified patients and need of our therapy. As mentioned on our recent call, our commercial team quickly pivoted their strategy to adapt to the current environment, to ensure a successful launch, the creative solutions they have developed, including a virtual platform have already provided for effective engagement with our healthcare professionals and key stakeholders. And the team remains on-track for a launch on June 1. Underscoring this momentum with the publication of the results from the pivotal Phase 3 OLYMPUS trial in the Lancet Oncology just last week, reporting a 59% complete response in patients with low-grade UTUC and 12-month durability based on interim data estimated at 84% for the Kaplan-Meier analysis. Mark will elaborate on this data and product labeling in a moment, but the results supported the approval of Jelmyto for treatment of patients with this difficult-to-treat cancer. With the approval secured, we are now accelerating research to further identify opportunities to bring Jelmyto to patients in other parts of the world. And we look forward to updating you on these plans as we progress. Beyond Jelmyto, our pipeline continues to advance as we look ahead to other medicines in areas of unmet need that could benefit from our proprietary technology or can leverage our core expertise in urologic and specialty cancers. Our latest stage product in development is UGN-102 for the treatment of patients with low-grade intermediate risk, non-muscle invasive bladder cancer. Patients with this type of bladder cancer remain a very challenging population, characterized by high rates of recurrence within 12 months and the need for repetitive surgical intervention. There are currently no drugs approved by the FDA for first-line treatment of this disease and the annual treatable population of patients with low-grade intermediate risk non-muscle invasive bladder cancer is approximately 80,000 patients in the US alone. Updated complete response and durability data from the Phase 2b OPTIMA II trial of UGN-102. And this patient population was recently included as part of a late-breaking abstract published in the April supplement to the Journal of Urology. We are very encouraged by the positive data, which Mark will discuss in more detail. These data combined with the data from the OLYMPUS for low-grade UTUC give us confidence in the potential of UGN-102 to have a profound impact and offer patients a better option for the treatment of this large and important patient population. We are on-track to finalize our pivotal study with the FDA and initiate later this year. Our approval of our first medicine in the positive Phase II data provide strong evidence of the of the actability of our innovative delivery technology, RTGel. We continue to support activities to develop novel medicines within UroGen and through external partnerships. Beyond low-grade disease, we continue to advance UGN-302, a combination of UGN-201, our TLR7/8 agonist, zalifrelimab, an anti-CTLA-4 antibody we licensed from Agenus [ph] for high-grade non-muscle invasive bladder cancer. While no one can fully predict the potential impact to our business and timeline based on the COVID-19 pandemic, our team remains dedicated to pioneering new approaches and treatment options for patients as we build a long-term sustainable growth company. The company is well capitalized and we remain confident we can achieve peak revenue potential of greater than $1 billion from our Jelmyto and UGN-102 programs alone, providing a strong foundation to build upon. With that, I will turn the call over to Mark to discuss our recent clinical updates. Mark?

Thank you, Liz. The last several months have obviously been very exciting for UroGen. I see our recent progress not only as the beginning of what's to come for our company, but also as a major milestone for the urologic community. The approval of Jelmyto is a validation of our technology and the potential applicability to improve standard of care and develop non-surgical therapies for diseases such as low-grade UTUC and low grade non-muscle invasive bladder cancer. These are diseases characterized by repetitive surgical intervention and associated risks in an elderly population and with low-grade UTUC, potential kidney removal in approximately 70% to 80% of patients and a host of additional comorbidities. Literature continues to emerge about the molecular and clinical similarities between these two disease. In the recent approval and supporting data in low-grade UTUC further fuel our confidence and excitement about the potential of UGN-102 in low-grade intermediate risk non-muscle invasive bladder cancer. We have spoken quite a bit about our leading neuro-oncology pipeline over the past several months. And today, I would like to highlight the data published in Lancet Oncology along with the ongoing progress of our UGN-102 program. As we discussed on our most recent call, the FDA approval of Jelmyto was based on positive results from the Phase 3 OLYMPUS study, which has demonstrated that Jelmyto achieved clinically significant disease eradication in adults with low-grade UTUC. OLYMPUS was designed as a pivotable open-label single-arm Phase 3 clinical trial of Jelmyto to evaluate the safety, tolerability and tumor ablative effect in patients with low-grade UTUC. The trial enrolled 71 patients at clinical sites across the United States and Israel. Study participants were treated with six weekly installations of Jelmyto administered via standard ureteral catheter, four to six weeks following the last installation, patients underwent a primary disease evaluation to determine response. And the primary endpoint of the study was this complete response. Primary disease evaluation involves the ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine to detect cancer. Patients who achieved a complete response remain followed for up to 12 months to determine the durability of disease control with Jelmyto. We intent to treat population included the 71 patients who received at least one dose of Jelmyto. 48% of these patients had tumors that were deemed endoscopically unresectable. These were patients who, according to the current standard of care, would have been candidates for immediate kidney removal. As reported in Lancet Oncology, Jelmyto achieved a complete response of 59% in the intent-to-treat population and durability of 12 months at the time of data cut-off was estimated to be 84% by Kaplan-Meier analysis. Overall, the most frequently reported adverse events were ureteral stenosis, urinary tract infection, haematuria, flank pain and nausea. No treatment-related deaths occurred. The FDA approved labeling for Jelmyto reports complete response based on the primary endpoint 58% in the intent-to-treat population. The product labeling also reports that at the 12-month time point for assessment of durability, 19 patients remained in complete response, seven had experienced recurrence of disease, nine patients continue to be followed for the 12-month duration of response and median duration of response was not reached as of the FDA approval date. You will know differences in CR and durability in our label versus the publication, reflecting the FDA method of evaluating patients, particularly given the approval was based on immature durability results. The final durability data will be available by June. And as discussed on our prior call, we will submit as soon as possible to have the label updated to reflect all patients at 12-month follow-up. We believe the longer-term data will remain consistent with the results shared to-date. As we look at the recent progress of our clinical development programs, our most advanced pipeline product candidate beyond Jelmyto, UGN-102 which is being developed for the treatment of patients with low-grade intermediate risk non-muscle invasive bladder cancer. We chose to focus on the intermediate risk group, as this is a disease that has been extremely challenging for urologist to control using standard of care surgical intervention or TURBT. Intermediate risk patients are defined as those patients with one or two of the following criteria, multifocal disease, large tumors and rapid rates of recurrence. Updated complete response and durability data in the Phase 2b OPTIMA II trial was recently included in a late-breaking abstract published in the April supplement to the journal of urology. This study demonstrated a complete response rate at three months following onset of treatment of 65%. Of those who achieved a complete response and underwent evaluation of six and nine months, 97% and 85% respectively remained disease free. Most commonly reported adverse events were dysuria, haematuria, urinary frequency, fatigue, urgency and urinary tract infection. And the majority reported as mild to moderate in severity. We look forward to sharing the detailed results in the presentation online via the virtual American Urological Association Annual Meeting in mid-May. As Liz mentioned, we remain actively engaged in discussions with the FDA to finalize the design for our pivotal Phase 3 protocol and still anticipate initiating the study in the second half of this year. We hope to communicate the final design as soon as feasible, but do not believe the ongoing discussion will delay or impact our timing for trial initiation. And with that, I would like to ask Jeff to provide an overview of commercialization activities we have underway as we look ahead to the planned Jelmyto launch. Jeff?

Thank you, Mark. And good morning, everyone. Since our last call, just a few weeks ago, our team has hit the ground running. We've been working diligently to ensure our readiness for the official commercial launch of Jelmyto on June 1st. The key takeaway is yes, we are ready. We've been actively monitoring the COVID-19 situation and we'll continue to adjust our solution-oriented mitigation strategies to help keep us on track for a successful launch. Our experienced commercial team has been in place for quite some time now. And as I mentioned on our recent call, they're fully trained and prepared for our adapted approach to launch. As you may recall, our sales force is comprised of 48 reps with successful track records in both urology and oncology. They've been in the field since January educating potential customers on the unmet need in low-grade UTUC. The team is led by seven regional business managers and is a part of account-based approach that we take. Each region includes support from a clinical nurse educator to provide training and support around the installation as well as a field reimbursement manager to ensure access and reimbursement. We believe this structure will allow our team to reach 90% of the patient potential. Additionally, we brought on a team seven medical science liaisons or MSLs, who have taken the appropriate steps to engage with our target physicians that are interested in learning more about UroGen and our novel technology. During this dynamic time with the COVID-19 pandemic, we found that physicians have really embraced the virtual meeting technology to increase the efficiency of their offices and we plan to continue this approach through the launch. I think it's important to reinforce that when Liz joined the company, we identified three critical commercial success factors, patient identification for this orphan indication, reliable reimbursement and a seamless integration into the physician practice. As part of our strategy, we have implemented programs to ensure we are successfully addressing these key areas. Leading up to the recent Jelmyto approval, our team spent significant effort over the past year, improving awareness, a critical element of adoption of our company and the unmet need for patients with low-grade UTUC. Through our market research, we've learned that urologists are increasingly dissatisfied with current treatment options for low-grade UTUC and that 88% desire a new and differentiated treatment option for patients. Urologists recognized the need for an alternative to radical surgery and have identified multiple opportunities to incorporate Jelmyto into their practice. The strong relationship between our veteran field team and the nurse navigators in these practices will enable rapid identification of patients upon diagnosis. Reimbursement is also key element of adoption. As many of you know, Jelmyto is a buy-and-bill drug and we understand physicians wanted to know that we reimburse before widely adopting. Our team of field reimbursement managers will be available to physician offices to ensure that when they need to complete the appropriate forms that they're completing correctly the first time around. We've also developed a support hub to assist offices with questions around reimbursement and to address any potential obstacles that might prohibit a patient from accessing Jelmyto. I'm pleased to say that our hub is already up and running and have received customer requests. And they are triaging those requests for follow-up. At approval, we announced that we have priced Jelmyto at $21,376 per dose. This reflects the value of Jelmyto to transform the treatment paradigm for low-grade UTUC to potentially delay the downstream sequela associated with kidney removal. Based on our conversations with payers, we remain confident in the coverage of Jelmyto. In addition, we are pleased to report that we've been added to the NCCN Clinical Practice Guidelines in Oncology. The NCCN guidelines are the recognized standard for clinical policy in cancer care. As an update to our last call, I'm also happy to announce that the team has completed the application for submission of the C-code. The submission of the J-code application is in process. We continued to expect that the C-code will be secured by October and a J-code by the end of the year if there is no disruption in timing, given the COVID-19 pandemic. In addition, the American Urological Association Policy and Advocacy Group just recently published an article with guidance on how to code for installation of medications to treat low-grade UTUC, which of course will apply to Jelmyto. Urologists and their staff will be able to utilize this resource as a guide when submitting for reimbursement. Finally, we remain concentrated on a seamless integration into physician practices. We've instituted processes to make the preparation and use of Jelmyto as easy as possible for practitioners and staff. As Jelmyto needs to be reconstituted with our gel prior to installation, we entered into an agreement with a major national pharmacy to help prepare and dispense the Jelmyto ad mixture on our behalf, following receipt of the patient prescription. This partnership ensures that Jelmyto is prepared under the appropriate USP conditions and in accordance with the exacting standards of the Jelmyto label to ensure patient safety. Based on the latest information, we do not foresee any disruption to our supply chain as a result of the COVID-19 pandemic. We look forward to the upcoming Virtual American Urological Association Annual Meeting in mid-May in addition to the presentations by Dr. Lerner on the OLYMPUS trial and Dr. Wang on the OPTIMA II trial, we will unveil platform of cutting-edge resources to maximize engagement with healthcare professionals and key stakeholders. These include a virtual booth and interactive exhibits to bring AUA to the physicians interested in our technology. Under Liz's leadership, we remain confident in our team's ability to address any barriers that may come our way as we drive towards launch and fill an unmet need in the urologic community with this effective kidney sparing treatment option. And with that, I would like to turn the call over to Peter, who will discuss financials.

Thank you, Jeff. And good morning to everyone on today's call. We closed the first quarter of 2020 with $159.2 million in cash, cash equivalents and marketable securities. This excludes restricted cash. For the first quarter and three months ended March 31, 2020, we reported net loss of $37.8 million or $1.79 per share. This compares to net losses of approximately $21.4 million or $1.11 per share for the same period in 2019. The net loss for the first quarter and three months ended March 31, 2020 includes $7.6 million in non-cash share-based compensation expense. Research and development expenses for the first quarter and three months ended March 31, 2020 were $16.6 million compared to $9.7 million for the same period in 2019. The quarter-on-quarter increase of $6.9 million from 2019 to 2020 is mostly due to a one-time settlement payment of $6.6 million to unwind our obligation to the IIA on grants provided to the company during the period 2004 through 2016. Research and development expenses also include $1.9 million of non-cash share-based compensation expenses for the first quarter and three months ended March 31, 2020 as compared to $2.3 million for the same period in 2019. Selling and marketing expenses for the first quarter and three months ended March 31, 2020 were $10.7 million as compared to $2.6 million for the same period in 2019. The increase in selling and marketing expenses of $8.1 million resulted from increased activity and preparation for the launch of Jelmyto, which includes the addition of the commercial field force. Selling and marketing expenses include $1.1 million of non-cash share-based compensation expenses for the first quarter and three months ended March 31, 2020 as compared to $0.4 million for the same period in 2019. General and administrative expenses for the first quarter and three months ended March 31, 2020 were $11.3 million as compared to $10.1 million for the same period in 2019. The increase in general and administrative expenses of 1.2 million resulted primarily from increases in headcount and a severance payment for senior officer. General and administrative expenses include $4.6 million of non-cash share-based compensation expense for the first quarter and three months ended March 31, 2020 as compared to $4.7 million for the same period in 2019. UroGen continues to be well capitalized as we prepare for the launch of Jelmyto and advance our clinical development programs, including the initiation of UGN-102 Phase 3 trial later this year. With that, operator, I would like to turn the call over for questions.

Certainly. [Operator Instructions] And our first question comes from the line of Raghuram Selvaraju. Your question please. From HC Wainwright.

Hi. This is Blair [ph] calling on for Ram. Couple of questions for you. Do you think the gradual reopening of states and the permissions to conduct selective surgeries should affect the launch of Jelmyto?

Hi, it's Liz. I'll comment and then if Jeff wants to add anything. I think what we've been saying all along and what we've seen so far is that first of all, there are some state in the country where things have not been as impacted. So it's definitely a geographical decision. We obviously think areas such as New Jersey and New York will still be slower to open. And Jeff can tell you in some of his conversations he has had where physicians are looking at doing things differently. Right. The good news about our therapy versus the alternative is that you don't have to do it in a hospital. And so what we've seen and actually I've read sometime the other day where all oncology treatment across the Board has been down 40%. And a lot of that is due to patients worry about going into the hospital, right, because there are a lot of COVID patients. So at this point in time, and again I'll ask Jeff to comment, we don't see it meaningfully changing our expectations, because as we've noted before, our revenue projections really started in the Q3, Q4 timeframe and the team has been able to do a lot of that work virtually and believe that will be able to get out. I do think in some large areas, which actually impacts us as well, because more patients are seeing in these urban areas, they may be slower to open. But, Jeff, do you have any other comments in addition to that?

Sure. Just to add a little bit with regards to the states that may be slower to open. Physicians are looking for solutions across the Board. They believe that the clinics will be probably the first to open and patients will be more open to go into their clinic versus the hospital. So they are looking to move CRM, which is the fluoroscopy machine into their clinic to possibly have another option of delivering Jelmyto in the clinic. Those that are interested now and have patience, they've all been key targets we talked about. They have a strong affiliation with the surgery center. Again, the surgery center is a place where patient would more likely wants to go, since they are treating COVID patients there. And yes, we could - the states that Liz mentioned will be a little slower, but the - from a geography standpoint, there is a handful of states that surgery centers are still open seeing patients and doesn't expect it to t delay there.

Perfect. And do you expect any changes to the BotuGel program under AbbVie now that the Allergan-AbbVie transaction has been cleared?

Do we expect any changes to our program with them?

Yes.

Yes. So, we don't think that - look - as soon as that acquisition was announced, we spoke to both AbbVie and Allergan. And they are still moving forward as planned. They did update the timing in clinicaltrial.gov which demonstrates a bit of a delay versus where they were. So, their primary completion date is now the end of June. Previously, it was at May and then you have a few months after that before they start to get the data. So, at this point in time, we have no further information except to believe that we'll have that by the end of the year. And I think the - only other thing to know is AbbVie has made it very clear that BOTOX is one of their priorities. And look we talk to them and said if they had any interest or didn't have interest in moving forward that we would absolutely have interest of moving, advancing that on our own, but they've made it very clear that they're interested in continuing this. So we don't really see any changes, except if there were some delays because of COVID or other thing, and the study actually getting finalized and then the pace, the pivotal study, hopefully, the pivotal study getting on board.

Okay, great. And last one for me. I know you reiterated the guidance for the Phase 3 and 102, but do you see any issues with enrollment because of COVID if it extends later for the year?

I think, again, we've said that the study would start toward the end of the year. We actually have patients coming in. So, I think unless it goes into next year, we don't see any delays. Clearly, if it does start to get heightened back up again in the winter like it maybe, then there could be a delay, mainly because not just in the US, but this is a global study. And so, we would have sites around the world. So, it may be a little bit slower, but we've been talking about this, and said that we will put all of our resources that are necessary to either add sites or make sure that we're going to high enrolling sites and doing all the things we can to ensure that we don't lose any time on our Phase 3 study.

Awesome. Thank you. That's it from me.

All right. Thank you.

Thank you. Our next question comes from the line of Derek Archila from Stifel. Your question please.

Just wondering if you can share some more info on the virtual launch plan. What could something add AUA look like? And then also the practices that you do plan to target, do you know how many of them are open now and treating patients or play to be open by June 1? Thanks.

So, Jeff, if you could answer that would be great.

Sure. So, we're going to bring AUA to the physicians. We are going to - the reps are going to have sort of a pop-up of our actual booth and they'll be able to go to the website. And we are going to have a couple of creative, innovative stations that the physician could go to at the live AUA. So instead, they're going to be able to, for example, to be able to manipulate that the temperature on an iPad and what's the Gel turn from liquid to semi-solid. They'll be able to then see the technology that fills the renal pelvis. So, we're going to - the plan is for everything that we are going to have from innovative standpoint AUA; we're going to bring AUA to the physician. And I apologize, could you repeat the second question around the basin?

Yes. Just on the practices that you guys going to target. Do you know how many are open right now in treating patients or plan to be opened by June 1?

Yes. So it's about 75%, I'd say, I don't want to give a - I'll give you a range 50% to 75% are open to treating patients and just literally waiting for us to get drive into the US. Others, I spoke to physicians from New York yesterday, as well as physicians from Virginia, July alone, probably a better target. They've obviously got a back load of patients, they are going to begin prioritizing soon, but those states will - won't be June 1, they'll be closer to July and August.

Okay. Thanks. And then just one more for us. I guess, Peter, I know you guys - so the guidance that you issued before still holds. But I was wondering if there are any qualitative comments you could add about how COVID will affect OpEx for 2020 both in respect to R&D and SG&A? And that's it, guys. Thanks for taking my questions.

Yes. So, with regards to our guidance, we are reiterating our guidance. I think, at this moment, so we've laid out the guidance for the Street earlier as part of our fourth quarter and full-year numbers back in March. That was operating expenditures of $145 million to $155 million, embedded in those numbers was in fact the settlement payment associated with the IIA which cleared out in the first quarter. With regards to the other guidance numbers that we provide to the Street, they also stand, those were around stock-based compensation, that was $32 million to $36 million for the full year. And then other operating income, which was $2.5 million for the year. Again, we feel very comfortable relative to all of those guidance numbers as of this moment. And there is no change relative to COVID-19.

Okay. Thanks, guys.

Thank you.

Next question comes from the line of Paul Choi from Goldman Sachs. Your question please.

Great. Thank you. Good morning, everyone. Maybe first with commercial question and just with regard to the feedback your sales force has been getting in terms of virtual interactions. Can you maybe just comment on how procedure volume such as operations and so forth have changed in the current backdrop? Just to sort of gauge, help us gauge what the volume change has been to help us think through the backlog of procedures at physicians' offices.

Liz, do you want me to take?

Yes.

Yes. So it depends institution to institution, I can tell you, from a virtual portfolio, your first question, I've had a couple of conversations that have gone 25, 30 minutes because physicians are certainly engaged. I know reps have had the same thing that - face-to-face is obviously always a better choice, but because physicians do have a little bit more time, the virtual presentations have gone extremely well. And can you clarify your second question, so that I mean I guess depending on where you are in a country - like I said - some group don't have backlog at all, others have a small backlog. It just depends on from a priority standpoint, we heard Mark talked about it. These patients that suffer from low-grade UTUC, the way about a month, they are not going to wait much longer than that from what we've heard. I mean they reminded every time they urinate that their cancer is back. And so what we've heard is the way about a month or two, but they certainly want to get treated because of the, obviously, the reminder that and the anxiety that they have with the cancer. From a prioritization standpoint, I'd say that this depends on the institution. And some I know are - there is not a priority, they're still treating others, for example, like up to some accounts again in the Northeast. They've got a few hundred patients that they've got to prioritize. So, hopefully that helps answer your question.

Okay. Sure, thanks for that. And then one for Mark as a follow-up. Just with regard to the next update from OPTIMA, I guess are you looking to have sort of a minimum number of patients just to present on the 12-month update? And then when could we potentially expect the 12-month data? Thank you very much.

Thanks, Paul. I think probably the best answer I can give you is, later this year we won't to be able to give a very clear view of the durability of the experience of these patients. And we already know that the complete response rate is very favorable and mimics what we've seen in the OLYMPUS trial. So, I think given the fact that at least directionally the information we have currently is very positive, we'd like to be able to tell our complete story and I suspect that will be later this year. But that's probably about a specific as I should be at this point.

Does that answer your question?

Yes, it does. Thank you very much.

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

Hi, guys. Good morning and thanks for taking the questions. I guess maybe first for Jeff and Liz. Can you talk about kind of the roll out of reimbursement and coverage that you expect to see during the year, as you're launching the product?

Yes, I'll let Jeff sort of get into the details on that. But I think it's always important to remember that whenever a drug first gets approved, you actually get reimbursement prior to any particular insurance company making a final decision. Having said that, and Jeff can expand upon this as - majority of these patients are Medicare patients. And Medicare, if a drug is approved by the FDA then Medicare reimburses. So we don't really see big issues, but Jeff can tell you kind of where we are with our coding and stuff. So Jeff, do you just want to expand upon that?

Sure. So, the patients that we - the providers that have patients right now, typically, this is the way it happens or the rollout is. You deliver [ph] clinical presentation, the rep will - the physicians want to understand the data in OLYMPUS and they handle all the questions from a clinical standpoint. The second call is oftentimes with the effect that - we will be doing coding and reimbursement. So that's where our field reimbursement manager will have a second call with those folks, sometimes with the physicians, most of the time not to sort of align on the correct coding, the correct reimbursement, how to fill the form out, that's normally the process. From miscellaneous code, C-code to J-code, if I could walk you through that, so we will have a miscellaneous code, we believe until October 1 at which that point will have a unique C-code. The C-code is the pass-through code for hospitals and surgery centers. And we'll have that unique to Jelmyto. So our pieces and promotions will talk to the miscellaneous code. In fact, the AUA site and article that I referenced earlier talked about what miscellaneous code they use. Once we have a C-code, obviously we will pull all of the pieces that we have replaced that with the C-code and then we expect the J-code by the end of the year. So the permanent J-code then supersedes the C-code. So that's sort of the transition we have as we go out. The current plan is because it's buy and bill, as we wait for the C-code providers will be using a miscellaneous code.

Okay, that's very helpful. Thank you. And I guess for Liz in terms of the strategy for approval of Jelmyto ex-US and using - what that data do you think it will suffice ex-US for approval?

Yes. We've shared some of that information in the past and to be honest with you, we sort of put on hold our work ex-US because the entire team and all of our resources were really focused on getting our FDA approval. And it was the right decision to do that at that time. So now we are starting to reengage with regulatory authorities, particularly in Europe and Japan obviously being the biggest market. The biggest issue in Europe isn't really getting approved or the biggest issue in Europe is getting a decent reimbursement, because many of the countries will do a comparison and they want to use generic mitomycin as the comparator, absent any other comparator. And so what we plan to do is have discussions with probably Germany and France being two of the big five that used direct competitors and see what they would like to see before they would give a decent reimbursement. And I think we'll revisit a question with the regulatory authorities there. They have a different view on orphan drug, status, but if we could get orphan drug status there, that will eliminate the issues around reimbursement. So we have a couple of strategies going into Europe. Japan, probably a little bit easier. Right. So, we - right now are scheduling, our next step there is to schedule a meeting with the Japan FDA, and actually ask them how many patients they are going to want to see a bridging study in the Asian population, how many patients would they want to see and then probably to conduct a small study to be able to get regulatory approval in Japan. So, and we've had other discussions with other companies around the world. But I think those will do hit there first. In addition to Israel, the good news about Israel, obviously is that they accept the FDA. So there will be some work that needs to be done to gain approval there, but it's important for us considering, we are an Israeli-based company and a lot of participants in the study were from Israel. So that would probably be one that's a little bit easier, but we could do. And then the rest of the world again will prioritize I think more likely when we get 102 up and running as I mentioned before, 102 will be a global study. So with the comparator and I think that plays better outside of the US as you can imagine with most of them expecting and wanting direct competitor. So that's really the biggest issue again in Europe, which is our - the biggest opportunity for us.

Okay. Okay, thank you. And last question maybe for Mark. Can you give us some details on your thinking for the Phase 3 design for UGN-102 and low-grade intermediate risk non-muscle invasive bladder cancer?

Thanks, Matt. Yes, I think, based on our conversations with the FDA and our internal discussions, we believe that the study is going to be a randomized trial comparing primary ablation to transurethral resection of bladder tumors, which is the contemporary standard of care. I think that we've received positive feedback from the regulators that this type of design and as well as from the urologic community. So I believe directionally that's the sort of the course that the trial design will ultimately take.

Okay. Thanks for taking my question, guys, and congrats on the progress.

Thank you.

Thank you. Our next question comes from the line of Boris Peaker from Cowen. Your question please.

Great. Thanks for squeezing me in [ph]. I just want to understand from the Jelmyto launch perspective. What kind of training does a doc need before they start using Jelmyto? And at this point, how many docs have been trained and how do you see that training increasing over time?

So Mark, maybe you can just talk about what you think a physician needs and then Jeff can talk to you about sort of our plan to ensure the education and training of physician.

Sure. Boris, thank you. Luckily for us, the acquisition of the skills to provide this therapy to patients is not complicated for urologists, because the instrumentation and the technique utilized is taught in all urology residency programs. And this is very basic straightforward stuff. So, urologic practitioners across the country already know how to do this, how to use the equipment and are familiar with the approach. The only finesse aspect of this therapy is learning how to inject - slightly viscous liquid, which is what Jelmyto is when it is cool prior to installation. So, it's a very familiar process and in our experience with the clinical trial was to participate in the OLYMPUS trial, it's a very little training to familiarize them with the technique. And I think Jeff has also spoken extensively with physicians about this and has a sense of what it would take to ramp up the training in community.

So, yes, we have a team of nurses - clinical nurse educators that will be there if the physician wants assistance. What we've typically heard is we need - maybe there may be the first dose, maybe the second, but certainly after that they are good. If for some reason, offices aren't comfortable with more people in the actual procedural room, we've also engaged with our Phase 3 OLYMPUS sites those that administered Jelmyto in the Phase 3. They will act as virtual proctors. So we will have a technology that will allow the nurse to kind of have - you have an iPad - be talking with the physician through the procedure. So, we've got roughly eight or nine of those folks on call if a physician were to want something virtually versus having or see any in the procedural room.

Got you. Okay. My last question maybe on the UGN-102 Phase 3 study. Assuming you get it started later this year, do you have kind of a ballpark sense of how long this study will take?

No. We have not finalized that. I haven't seen it yet. We actually are having a meeting this week to review. And we expect it will be several hundred patients. So, we will definitely be a two to three year program, but we don't have the exact numbers yet.

Okay, great. Thank you very much for taking my question.

Thanks.

Thank you. Our next question comes from the line of Leland Gershell from Oppenheimer. Your question please.

Good morning. Thanks for taking my questions. Just one quick question for Jeff. As the reopenings across the country are inconsistent, variation in terms of geographies, wanted to know if you're going to use that pattern to inform where you place your efforts initially as you want to [ph] Jelmyto versus simply covering the territories irrespective of reopenings and the pace of kind of normalization? Thanks.

Yes. So the reps will be - it will just be sort of facing on the patients. I know rep had - there is a very large group in Virginia and the rep recently had a clinical conversation. They'll just - they'll stay engaged with the practice they'll follow and respect the procedures that the practice puts in place. The key for us now as Liz mentioned, I mentioned earlier is really identifying the patients in that orphan drug. So this gives them maybe a little bit more time to work with the nurse navigator and identify the patient. So I think the rep after will stay consistent across the US, they'll just have to be patient with regards to where, what the institutions policies are. But, yes, we're not going to delay. For example, like I said, we are not - if the physician can talk to us in Virginia, New York, New Jersey area, we're certainly engaging them virtually and that means [ph] you need to have contact with those both. We'll just have to wait until those institutions open their doors.

Great, thank you very much.

Sure.

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

Excellent. Thank you very much. So for Jeff, maybe I was just thinking about the cadence to the launch here. So one of the comments you made was that physicians won't widely adopt this until they're comfortable that they will attain reimbursement. So I guess I was just wondering how many patients typically do doctors serve? And what is the relative effort to an acquisition costs, let's say, to compared to physician as a user of Jelmyto generally versus a broader adoption within their patients?

Yes. So each account is different, but if I walk into a typical larger group where there's 20 or 25 urologists, there is, you could be [ph] one or two that create a significant amount of bladder cancer or upper tract, and then really a lot of the physicians in that group have a few patients. I think when I say widely adopted, they're going to want that first patient, as I said, they're going to want to see the reimbursement from an accuracy standpoint. I do think we - it will be quick. We've had conversations with regard to some of the CEOs, some of the COOs in and around our policies that we put in place with - while we have a miscellaneous code. When I say, it will be adopted, I do think like once they treat their first patient, once they start to see the accurate reimbursement, you'll start - you'll just start to see like every other drug, it starts to pick up a little bit more efforts to find patients in their system picks up a little bit more, but I don't expect anything to slow down with the miscellaneous code. They are used to miscellaneous codes with other drugs like Provenge and Xofigo. And so, hopefully Chris, that answers your question.

Yes. No, no, that definitely does. And I guess another one. I don't know if this would be appropriate for you Jeff or potentially Peter, just maybe if you could give us some color around what you expect the gross to net to be particularly given the idea that a majority of these patients are Medicare?

Yes. This is Liz. I mean, I'll just make a comment about it, because we really haven't provided guidance around gross to net. I think the best way to sort of think about gross to net, I don't think that Medicare really is the determining factor there. But I think you - we won't be discounting right, I don't know if that was your point around Medicare patients. But even alternatively there aren't alternatives. Right. So, you are not in a situation where many other therapeutic areas have multiple products in that area and so therefore, no need to discount. So I think the best way to think about it is in the context, you had - we will have sort of some of your traditional gross to net costs associated with admin fees and those types of typical discount fees, but I think that's sort of the best way to think about it. But you wouldn't expect heavy gross to net due to discounting with insurance company.

Sure, okay. And then last one, I think quickly for Mark for the presentation later this month, that is part of the virtual AUA. Will we get an update on safety in that trial and I guess what are the details might we learn outside of what we already know?

Yes, Chris. Thank you. We will certainly give you a sense of adverse events encountered so far, which I can say think we are mild, moderate and unexpected given the therapy that we're delivering. But I think apart from some additional incremental durability data, it will be the overall complexion of the trial as we understand it right now, understanding that these are interim data obviously and we have not completed the study.

Okay. Well, thank you very much and I appreciate you taking my questions.

Thank you.

Thanks, Chris.

This does conclude the question-and-answer session of today's program. I would like to hand the program back to Liz Barrett, President and Chief Executive Officer for any further remarks.

Thank you, operator. And thanks everyone for joining and your interest in UroGen. Just a couple of weeks ago, when we received approval, I received many messages from my peers and colleagues, reminding me that most biotech companies never get to this day. So it's an exciting time for us. I'm incredibly proud of our team and confident in our ability to advance our mission to pioneer new treatment to improve patient care and specialty cancers in urologic diseases. Our team has been working tirelessly to provide Jelmyto to patients who have been waiting. And so as we approach the exciting events on the horizon, we look forward to staying in touch with you, as we deliver - continue to deliver patient and shareholder value. So thanks everybody for your time and your continued support. So, operator, you may now disconnect. Thank you.

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