UroGen Pharma Ltd. Q4 FY2020 Earnings Call

Thank you, Jonathan. Good morning, everyone. And welcome to UroGen Pharma’s fourth quarter and full year 2020 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter and year ended December 31, 2020. The press release can be accessed on the Investors portion of our website at investors.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 Molly Henderson, Chief Financial Officer. Please note that we continue to conduct our calls from different locations, so we appreciate your patience and understanding should we have any technical difficulties. Liz will provide a summary of our recent corporate developments, Mark will share clinical development updates, and Jeff will provide commercial updates. Molly will then provide an overview of our financial highlights for the fourth quarter and full year before we open the call for questions. During today’s call, we will be making certain forward-looking statements. This may include statements regarding the timing of our ongoing and planned clinical trials, Jelmyto commercialization, data presentation, potential regulatory filings, future research and clinical development efforts, our ability to change treatment paradigm, manufacturing capabilities, future expectations, plans and prospects and 2021 financial guidance among other things. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of UroGen Pharma’s annual report on Form 10-K 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, commercialization and product development plans caused by or associated with the COVID-19 pandemic to the extent not disclosed previously. We encourage all investors to read the company’s annual report on Form 10-K and 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, Sara, and thank you to everyone joining us today. It’s not an understatement to say that 2020 was memorable for everyone. Despite the challenges we face collectively, it’s been inspiring to see how innovation in the pharma and biotech industries have persevered to the benefit of society. Although this is what our industry does day in and day out, I am grateful to see that heroic efforts being universally applauded. While that work has rightfully been on the forefront, many diseases don’t become front-page news, but they do take center stage for the individuals who have been diagnosed. UroGen is focused on developing treatments, focused on urologic and specialty cancers. Last year, our first approved therapy, Jelmyto, became the first and only FDA-approved non-surgical treatment option for adult patients with low-grade upper tract urothelial cancer. Although launching Jelmyto in the midst of the COVID-19 pandemic certainly presented challenges, we are incredibly pleased with the way our team has responded to those challenges in the first two full quarters of launch. We recorded $8 million in net product sales for the fourth quarter of 2020 and $11.8 million since the June 1, 2020 launch. We continue to be mindful of the environment we’re operating in, including the vaccine rollout and its impact on the healthcare system and the patient populations we serve. We have seen these trends have an impact on patient procedures, including Jelmyto uptake in the first two months of 2021. We continue to closely monitor, and Jeff and Molly will provide more details on our progress shortly. But we remain confident in the outlook for continued and accelerated adoption as the year progresses. And the demonstration of what’s possible makes us even more enthusiastic for what’s to come. We’ve made important progress in advancing our pipeline and executing on our near- and long-term growth strategies. Most recently, we initiated the ATLAS trial, our Phase 3 clinical study of our lead product candidate, UGN-102, for patients diagnosed with low-grade intermediate risk non-muscle invasive bladder cancer. We’re very excited about the UGN-102 program for many reasons, but mainly for the significant unmet need in this patient population with no FDA approved primary treatment options. We believe that there are important similarities across the therapeutic indications for both Jelmyto and UGN-102, and we hope to leverage our learnings and experience from Jelmyto and apply those to UGN-102 and its potential for these approximately 80,000 patients annually in the U.S. alone. The low-grade intermediate risk patient is a unique patient population, identified as at high risk for recurrence, and the current standard is just not good enough. In our Phase 2b study, 57% of patients had received three or more TURBT surgeries prior to enrolling in the trial. These patients deserve better options, and if UGN-102 is approved, these patients may benefit from the first primary non-surgical treatment options. We were very encouraged by the data we shared from the OPTIMA II trial, showing a strong complete and importantly durable response, and believe it supports UGN-102’s potential as an outpatient treatment option for these patients. We intend to present these data at an upcoming medical meeting and publish it in a peer-reviewed journal. Our work extends beyond low-grade disease to high-grade disease. Our early-stage programs, most notably UGN-302, is initially being studied in high-grade non-muscle invasive bladder cancer, a life-threatening disease with risk of progression. We believe that UGN-302, which is a combination of UGN-201, our TLR 7/8 agonist and UGN-301, the anti-CTLA-4 antibody that we licensed from Agenus, combined with our gel technology has the potential to transform this disease and provide advanced treatment options that are currently available. The recently announced three-year research collaboration with the University of Texas MD Anderson Cancer Center is aimed at advancing this combinatorial intravesical immunotherapy for the treatment of high-grade non-muscle invasive bladder cancer, with initial focus on UGN-302. We’re particularly excited to leverage the collective experience of Dr. James Allison and Dr. Pam Sharma, who have both been instrumental in developing breakthrough therapies with immuno-oncology. We continue to expand our focus in immunotherapy research utilizing our proprietary technology with checkpoint inhibitors, as reflected in this week’s announcement of a non-clinical sponsored research agreement with Johns Hopkins University to explore this combination in Glioblastoma Multiforme or GBM, an aggressive and difficult-to-treat brain cancer. These two important programs with world-renowned academic institutions are part of our ongoing efforts to expand our pipeline and realize the full potential of our proprietary RTGel platform. As we look ahead, we are pleased to announce that we completed a strategic transaction with RTW, providing funding of $75 million. We believe this will serve to fuel our mission to advance and bring life-altering therapies to patients. Molly will provide additional detail on this important transaction shortly. This funding ensures a solid financial outlook for our company. As we look ahead, we are building a company to transform how we treat specialty cancers and neurologic diseases. We have and continue to deliver on all of our commitments, and I am proud of the work we are doing. We face challenges every day and our colleagues rise to overcome barriers, because we share a vision to have an impact on patients that need our medicines. We have a strong foundation to ensure a long-term growth business and realize leadership by delivering new approaches to patients that have been left behind. With that, I’ll turn the call over to Mark to discuss our recent clinical update.

Thank you, Liz. It’s exciting to see the impact Jelmyto is having on real-world practice and an exciting time for patients, as we continue to expand our pipeline in important areas of uro-oncology. During the fourth quarter of 2020, Dr. Surena Matin from MD Anderson presented the final durability data from our Phase 3 OLYMPUS pivotal trial evaluating Jelmyto in low-grade upper tract urothelial cancer in a virtual podium presentation at the 21st Annual Meeting of the Society of Urologic Oncology. We were pleased to see that in both the OLYMPUS intent-to-treat population and in the sub-population of patients who were deemed to have unresectable disease. At study entry, 58% of patients achieved a complete response with durability of response at 12 months estimated to be 81.8% by Kaplan-Meier analysis. Median time to recurrence was not reached. The safety profile in the OLYMPUS data was consistent with previously reported results. This was previously a disease where options for patients included multiple endoscopic procedures or the removal of the kidney and ureter, both of which have consequences impacting patient health and quality of life. These final durability data from OLYMPUS were in line with our expectations and support the use of Jelmyto as a less invasive kidney-preserving durable treatment for a low-grade upper tract urothelial carcinoma, which may reduce the need for multiple endoscopy procedures or loss of a kidney. We also have several updates to provide for our UGN-102 program since our last quarterly call. The first of which is the final topline data from the OPTIMA II Phase 2b trial evaluating UGN-102 as primary therapy in patients with low-grade intermediate risk non-muscle invasive bladder cancer that we announced in November. This study shows that 65% of patients 41 and 63 received the UGN-102 achieve the complete response three months after the start of therapy. In this subset of patients, duration of response to 12 months from the start of therapy was estimated by Kaplan-Meier analysis to be 72.5%. The median duration of response was not reached. Treatment with UGN-102 was generally well tolerated and the safety profile was consistent with previously reported results, with mostly mild to moderate adverse events that resolve over time. In the trial, we observed typical symptoms of exposure to mitomycin and no treatment-related serious adverse events were reported. As was mentioned, we initiated the ATLAS trial, our Phase 3 study of UGN-102 in December and are actively enrolling patients. ATLAS is a randomized controlled global study and will enroll approximately 630 patients and compare UGN-102 plus or minus transurethral resection of bladder tumor or TURBT to TURBT alone, which is standard-of-care in patients diagnosed with low-grade intermediate risk non-muscle invasive bladder cancer. We are following the same enrollment criteria used in our Phase 2b OPTIMA II trial and expect to enroll a similar population. Patients will be randomized one to one to either upfront UGN-102 treatments or TURBT, and at the three-month time point, patients will be assessed for response. Patients who have demonstrated a complete response to either UGN-102 or TURBT will be monitored quarterly for evidence of recurrence. Patients who have tumor present on evaluation at three months in either arm will undergo TURBT and then undergo identical monitoring for recurrence. The primary endpoint of the study is disease-free survival or recurrence-free survival in this disease. The trial is a time-to-event analysis designed to evaluate non-inferiority and superiority. We expect the trial to take approximately one year to enroll and to be completed within approximately three years. There are no non-surgical primary therapies approved in this patient population, and today, patients are managed through repeated transurethral procedures under general anesthesia with a minority of patients receiving adjunct water-based chemotherapy. For published literature, two-thirds of patients have two or more recurrences and approximately one-fourth have five or more recurrences throughout the course of their disease. I see these patients in my practice, and with each recurrence comes an additional surgery. Although the risk of death from disease is relatively modest, the risk of repetitive surgery is real, and these risks include unintended hospitalization for bleeding and infection, as well as a recently reported risk of increased mortality following multiple surgeries for non-muscle invasive bladder cancer. It is our belief that the ATLAS trial is designed to effectively demonstrate UGN-102’s potential to change the treatment paradigm by providing a useful non-surgical therapeutic alternative to patients so they can avoid the potential comorbidities and complications that come from repeated TURBT. We look forward to providing enrollment updates on this trial later this year. While there are many similarities with Jelmyto and UGN-102, both represent important advances in patient care. One important differentiation is the additional ease of administration that we believe UGN-102 may offer patients. Given the feedback we’ve received from our clinical trials, including the potential for a nurse to administer UGN-102, we are planning a small feasibility study to assess the potential for at-home installation. We are currently in the final planning stages of this study and expect to start sometime this year. We will provide more details as we progress, but believe that the potential ease and flexibility of administration could be an important differentiator for patients with this disease. We’re also focused on expanding our immuno-oncology pipeline, specifically UGN-302, which is a combinatorial approach, initially being developed for patients with high-grade non-muscle invasive bladder cancer. As Liz mentioned, UGN-302 is a combination of UGN-201, our TLR 7/8 agonist, and UGN-301, or zalifrelimab, an anti-CTLA-4 antibody that we have combined with our RTGel technology. There are significant differences between high-grade disease and low-grade disease that we focus on with Jelmyto and UGN-102. High-grade non-muscle invasive bladder cancer is an aggressive and potentially life-threatening malignancy characterized by both a significant risk of recurrence and disease progression to muscle-invasive cancer. We know that some patients with high-grade non-muscle invasive bladder cancer respond to immunotherapy using Bacillus Calmette-Guérin or BCG. So there is a strong predicate rationale for exploring potentially better immunotherapies for the treatment of this patient population. As we’ve shared before, the non-clinical data that the UGN-302 program has generated to-date have been very encouraging, as the combination of UGN-201 and an anti-CTLA-4 antibody has resulted in improved survival and decreased tumor size in our murine model. Additionally, we observed changes in immunological markers such as decreased T regulatory cells and a trend toward increased CD8 T-reg ratios. It is our belief that the data generated to-date support the potential of a locally applied combinatorial immunotherapy. We are thrilled to be collaborating with MD Anderson on this novel program, given their expertise in innovative clinical trials and infrastructure. We expect to progress the UGN-302 program this year, which includes potential non-clinical studies for UGN-301 and the combination of UGN-201 and UGN-301, as well as clinical studies for UGN-201. We are working closely with MD Anderson on next steps and trial designs, and we will continue to share details as they are available. The second immuno-oncology program highlight is an interesting new sponsored research agreement with Johns Hopkins University where we intend to explore in a preclinical setting the potential of checkpoint inhibitors combined with RTGel in Glioblastoma Multiforme or GBM. This program stems from our focus on expanding our novel RTGel technology in combination with other medicines to provide treatment options for patients in diseases with significant unmet need, and where local immune modulation may make a difference. Our focus with this program is GBM, an aggressive malignant brain tumor, with a five-year survival rate of less than 5%. GBM is difficult to treat and treatment options today are limited and typically include surgery followed by radiation and chemotherapy. It is the most common primary brain tumor with around 12,000 cases diagnosed per year. With this research, we will examine combining our novel RTGel technology with anti-PD-1 and anti-CTLA-4 antibodies, respectively, to assess the impact on survival in a mouse model of GBM. While early, we continue to investigate the potential of our RTGel platform in immuno-oncology and explore local applications of immunotherapy, both within our laboratory and in working with key academic centers, who may leverage our technology exploring therapeutic options. And with that, I’d like to turn the call over to Jeff to provide a commercial update.

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

Thank you, Jeff, and thank you to everyone who joined today’s call. Before I discuss our fourth quarter and year-end 2020 financials, I’d like to touch upon the strategic transaction announced this morning with RTW and provide some details. We are pleased to partner with RTW, an influential healthcare investor whose mission is to invest in innovative companies looking to bring important new products to patients. RTW is research-driven, and we believe this investment reflects their confidence in the UroGen team and the important impact that Jelmyto has on patients, as well as the excitement surrounding the potential opportunity for UGN-102 and non-muscle invasive bladder cancer. The $75 million in funding from RTW puts us in a solid financial position to support the continued launch of Jelmyto and the development of UGN-102. In return, RTW will receive tiered future cash payments based upon global annual net sales of Jelmyto equal to 9.5% of annual net sales up to $200 million, 3% of annual net sales between $200 million and $300 million, and 1% of annual net sales above $300 million. If certain annual revenue thresholds for Jelmyto’s aggregate worldwide net sales are not met, the future payments with respect to the first year of net sales will increase by 3.5% and subsequently decrease depending on meeting certain annual net sales thresholds. In addition, RTW will receive tiered future payments based on global annual net sales of UGN-102, subject to FDA approval, equal to 2.5% of annual net sales up to $200 million, 1% of annual net sales between $200 million and $300 million, and 0.5% of annual net sales above $300 million. Payments based on net sales of both Jelmyto and UGN-102 will terminate upon the date that RTW has received an aggregate amount equal to $300 million. We are excited to partner with RTW, an industry leader providing UroGen with a solid balance sheet to execute on our mission. I will now take a moment to review the fourth quarter and year-end 2020 financials. UroGen recorded net product sales of Jelmyto for the fourth quarter 2020 of approximately $8 million. Full year 2020 net product sales of Jelmyto, which launched on June 1, 2020, were $11.8 million. Before turning to the cost of revenues, I’d like to mention a few external trends that we’re watching as we start 2021. First, as Liz and Jeff mentioned, we continue to be mindful of the evolving pandemic landscape and expect the vaccine rollout to have an impact on our first quarter 2021 results. Second, we are cognizant of the severe weather in the U.S. throughout the first quarter of this year and the impact that it has had on shipments of Jelmyto to patients. Lastly, given the concerns over potential shipment delays around the year and the holidays last year, we received several bulk orders at the end of 2020 that were recognized in 2020 revenue of approximately $500,000 to $800,000. We don’t anticipate similar bulk purchases or stocking patterns in the first quarter of 2021. Based on these three impacts, we are carefully monitoring our Q1 revenues for 2021. Turning to the cost of revenues for the fourth quarter of 2020 and the year ended December 31, 2020. Cost of revenues were approximately $652,000 and $1 million, respectively, and included certain one-time startup costs in periods prior to receiving FDA approval of Jelmyto, and pursuant to accounting rules, we recognize inventory and related costs associated with the manufacturing of Jelmyto as research and development expenses. We expect a favorable impact on cost of revenues through the first quarter of 2022, as we deplete inventories that we had expensed prior to receiving FDA approval. Research and development expenses for the fourth quarter and year ended December 31, 2020, were $12.4 million and $47.3 million, respectively, compared to $20.1 million and $49.3 million, respectively, for the same periods in 2019. Research and development expenses for 2019 included a $10 million milestone payment related to our license agreement with Agenus. Setting aside that expense, research and development expenses increased by $8 million year-over-year. The increase of $8 million resulted primarily from a one-time payment of $6.6 million to unwind the company’s obligations to the Israeli Innovation Authority during the first quarter of 2020 and increased expenses related to UGN-102 clinical trial and UGN-201 studies, partially offset by the completion of the Jelmyto Phase 3 clinical trial and reduced regulatory activity. Research and development expense also includes $1.4 million and $6.4 million of non-cash share-based compensation expense for the fourth quarter and year ended December 31, 2020, respectively, as compared to $1.9 million and $8.3 million, respectively, for the same period in 2019. Selling, general, and administrative expenses for the fourth quarter and year ended December 31, 2020, were $22.2 million and $90.2 million, respectively, as compared to $19.7 million and $60.2 million, respectively, for the same periods in 2019. The increase in annual selling, general, and administrative expenses resulted primarily from increased costs and activities related to the commercial launch of Jelmyto in June of 2020, including headcount and related costs associated with building our sales force and administrative costs. Selling, general, and administrative expenses included $5.1 million and $21.6 million of non-cash share-based compensation expense for the fourth quarter and year ended December 31, 2020, respectively, as compared to $6.2 million and $21.7 million, respectively, for the same period in 2019. For the fourth quarter and year-end December 31, 2020, we reported a loss of $32.5 million or $1.38 per share and $128.5 million or $5.90 per share, respectively. This compares to net losses of approximately $39 million or $1.86 per share and $105.1 million or $5.12 per share, respectively, for the same periods in 2019. The loss for the fourth quarter and year ended December 31, 2020, includes $6.5 million and $28 million, respectively, of non-cash share-based compensation expense. Our guidance for 2021 operating expenses is in the range of $155 million to $170 million. This is largely driven by the initiation of our Phase 3 ATLAS study late last year. This includes an estimated non-cash share-based compensation expense of $24 million to $28 million, subject to market conditions. Lastly, we closed the fourth quarter and year-end with approximately $103.9 million in cash and cash equivalents and marketable securities with no debt. This was supplemented post-year-end by the $75 million in funding we announced this morning from RTW. We believe we are in a solid position to execute on our strategy. With that, Operator, I would like to turn over the call for questions.

Our first question comes from Chris Howerton from Jefferies. Please go ahead with your question.

Excellent. Good morning and thank you for the questions. I appreciate all the progress made during a challenging year. To start off, Jeff, regarding the repeat customers, I'm curious if you've observed any trends there, specifically if they tend to be more from academic centers or community centers. What are your expectations or insights on that? Secondly, concerning the first quarter revenue numbers, I want to fully grasp the expected dynamics of the net revenues. Molly, you mentioned some weather-related shipment delays and possibly larger orders in the fourth quarter. Additionally, is there anything to clarify regarding the payer environment, such as payment plan resets? Could you help us understand the expected dynamics for the first quarter revenue figures? That’s all for now, but I may have a follow-up.

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

Thanks, Liz. Hi, Chris. In response to your first question, approximately 60% to 70% of the patients or physicians with multiple patients are primarily in the hospital. However, we also have community accounts where several physicians are prescribing Jelmyto for their patients, as well as individual physicians who have identified more than one patient. As I mentioned before, I continue to expect that this will increasingly shift towards community practices adopting and treating multiple patients. For now, though, the majority of multiple patients are coming from the hospital setting.

Great. Okay.

Hi, Chris. To answer your question about the Q1 revenues, as Jeff and I mentioned, we began noticing some softness in January and February this year. Many of the reasons we discussed were related to the vaccine rollout and weather impacts. However, we are starting to see a rebound from that. The patient population we serve overlaps with those getting vaccinated, which aligns with the recovery we are witnessing in March. Since we are still in the first quarter, we won’t provide further clarity on our expectations because we have a couple more weeks to go. However, we wanted to highlight the market dynamics we are monitoring.

Okay.

And then, maybe, lastly, as it relates to some of the stocking charges we saw last year, I referenced about a $500,000 to $800,000 estimate based upon some indication we got from certain practices that they were looking to stock and/or get ahead of any shipment concerns. Remember, last year’s holiday season, there was a lot of delays in shipments. So we saw some of that in advance buying last year, and we’re not going to see a similar pattern. So one of the queues and market into some of that dynamic as well.

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

Jeff, do you want to take the impact to patient treatment?

Sure. So it did impact. We had a few that needed to be rescheduled. Fortunately, the OLYMPUS trial was designed that though it’s once weekly, not everyone was got a dose every seven days. So they were able to miss a day or two in the OLYMPUS trial; therefore, physicians held comfortable, and obviously, given the weather that we had, shipments were delayed by a day or two, they just simply rescheduled those patients.

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

Yeah. Okay. All right. Well, great. Thanks so much for all the answers and again appreciate all the progress.

Thanks, Chris.

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

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

Sure, good morning, Derek. Regarding the J-Code, we've noticed that the community tends to have some anxiety about miscellaneous codes, which makes them appreciate having the J-Code that is specific to our product. They are being trained by CMS, which has provided guidance on proper billing for the drugs. This has certainly contributed to the expected increase in use within the community, and I anticipate that having a permanent J-Code will support this trend moving forward.

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

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

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

Yeah. Thanks. Congrats again.

Yeah. Thank you, Derek.

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

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

Yeah. Jeff, why don’t you take those?

It's consistent with what we observed in the OLYMPUS trial. When physicians choose to share information about patient progress, we have access to that data. Maintenance therapy has typically been a topic for physician discussion. I can say that we have an increasing number of patients and physicians considering maintenance therapy and initiating it, but the majority of patients are still receiving the six doses without maintenance.

The only comment about CR is that what we're seeing is anecdotal, and we aren't capturing real world CR. However, anecdotally, I would say it's at least as good or better, and it's well tolerated. We do capture the MEAs that have to come into the company, so we feel confident about both the efficacy and safety. Do you have a follow-up question, Hannah?

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

We are definitely interested in starting that study as soon as it is feasible. The reason I mention this is that patients need to have a recurrence after responding well to the treatment. Since patients have only been on the treatment for the last six months, we do not expect to start that study until the end of this year and likely into 2022. However, we know that there have been patients in the study who have undergone retreatment, which is already part of our label, but we would like to gather additional data on retreatment. While this is not preventing physicians from retreating patients, we want to ensure we capture data on this. It will be several months before we can even begin that study.

Okay. Great. Very helpful. Thanks for taking the question.

All right. Thank you.

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

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

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

Sure. Thanks, Matt. To answer your question simply, it depends on your location, the severity of cases in that area, and when delays on elective procedures were implemented. Most procedures that had been postponed are now on hold. Elective procedures are starting back up, and as you mentioned, they will begin prioritizing patients. With the decline in COVID cases, we've seen an increase in patient enrollments.

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

Liz…

No.

Exactly.

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

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

No, I think that’s correct. To address your question, Matt, as Mark mentioned, we estimated around 50%, understanding that literature indicates recurrence rates for those patients can range from 50% to 80% if they only undergo a TURBT and meet the criteria for intermediate risk. We also relied on our Phase 2 data for our assumptions, while being conservative in our approach. This positions us well for technical success.

Great. Thanks for that detail and thanks for the questions.

Thanks, Matt.

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

Hi. Good morning, team, and I want to congratulate you on the progress as well. I would like to revisit ATLAS, particularly regarding your comments about patients being treated at home. My question has two parts: First, do you view this as a possible real-world treatment option for the low-grade intermediate risk population instead of treatment in a clinic or hospital? Secondly, if there is potential for an at-home treatment model, how might that impact the economics of UGN-102 given our current environment?

Thank you, Paul. How are you? From our perspective, we want to make things as easy as possible for patients. When you think about TURBT, there's a common misconception that it's not a big deal. Our study shows that 57% of patients had three or more TURBTs, and this patient population indicates that as the number increases, it is an independent factor for mortality. We are considering how our therapy can differentiate itself from existing solutions, which often fall short. Additionally, this patient population is largely elderly. While we believe that most patients will still seek treatment in a clinic, having the option for at-home treatment could benefit those who are reluctant or unable to visit a doctor. We don’t expect this to impact our financials since treatment at home would be provided through a home health company. For physicians, it’s clear they would earn more if patients come into the office, but we think offering this option to patients is crucial. While our financials remain stable, the office's financials would be affected as they would see revenue only if patients visit their facilities.

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

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

We have a very small number of Medicare patients without supplemental insurance. I don’t think this has much of an impact. We’ve prioritized the vaccine from both the patient and provider perspectives. The majority of our accounts are now reviewing formulary views, and things are returning to normal for providers. There’s a minimal impact regarding out-of-pocket costs since most of our patients have supplemental insurance.

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

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

Great. Thank you.

Thank you. Our next question comes from Ram Selvaraju from H.C. Wainwright. Please go ahead with your question.

Good morning. This is Mark speaking on behalf of Ram. Thank you for taking our questions. I have a couple of questions regarding the impact of COVID and then two follow-ups. First, regarding the Jelmyto sales efforts in the context of COVID-19, do you expect to carry out the same promotional activities in the upcoming months that were previously restricted? Additionally, with the progress of the COVID-19 pandemic, concerning the ATLAS trial enrollment, you indicated that you would provide an enrollment update. Do you foresee any logistical challenges in executing the trial due to COVID-19, and if so, what are they and how are you addressing them? Thank you.

I’ll address the study. We expected some delays regarding enrollment, which typically starts slow. We ensured the study was conducted globally. While a few countries experienced delays in starting the study, others did not. We will keep working through these challenges. We feel confident with the number of sites available, which is one reason we increased the number from our initial estimate. This was to ensure that if a country or area shuts down due to COVID, we can compensate for that enrollment from other locations. Jeff, would you like to discuss promotion?

We have observed an increase in face-to-face interactions. Recently, I had the opportunity to meet with some accounts, and the improvement in face-to-face meetings is noticeable. Clients are becoming more open to having representatives come in for presentations over lunch. Many locations that previously limited such interactions are gradually allowing more face-to-face engagement. In areas where this is still restricted, our team continues to effectively conduct virtual reminders and presentations with physicians while being respectful of their current preferences. I'm pleased to report that face-to-face interactions are on the rise, and I believe this trend will continue as COVID cases decrease.

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

No, I expect both to grow. I think someone asked about our goal to have all of our sites activated and treating more than one patient. We want to reach a point where physicians are adopting it. Initially, there is usually a champion in the office, and the goal of our representatives is to engage with other physicians. I expect the numbers to continue to increase as we have a significant number of accounts either putting Jelmyto on formulary or looking for patients. Once they experience using Jelmyto, they may find more patients or influence their peers. All of these accounts have tumor boards or medical meetings with urologists, so ensuring we are part of that agenda is crucial to getting more urologists within an account to consider Jelmyto for their patients.

Okay. Great. And then just the final two housekeeping questions. So, are there any timeframe restrictions on the funding received from RTW investments? So, in other words, does RTW have the right to impose additional conditions or require additional consideration of the $300 million amounts not paid back within a specific period of time? And will are these additional commissions if any, so if funding from RTW secured by any of UroGen’s IP tax?

Molly?

Yes. To answer your question, there is no commitment to a specific timeframe concerning the $300 million achieved over a certain period. So, to clarify, there are no time commitments involved. Regarding collateral, they certainly hold a security interest in the strip of Jelmyto. This is also included in the IP interest, but we do not believe this would prevent us from pursuing opportunities outside the U.S. or other business development activities in these products.

Perfect. Makes sense. Thanks for taking my questions.

Great. Thank you.

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

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

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