UroGen Pharma Q3 2026 Earnings Call Transcript

UroGen Pharma (NASDAQ:URGN) reported third-quarter financial results on Wednesday. The transcript from the company’s third-quarter earnings call has been provided below.

This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation.

View the webcast at https://edge.media-server.com/mmc/p/nhp28fed/

Summary

UroGen Pharma reported a strong third quarter, with Zesturi generating $68 million in net product revenue, a 35% increase quarter-over-quarter driven by increased physician adoption and repeat utilization.

The company is expanding its market presence for Zesturi, the only FDA-approved primary therapy for recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer, by focusing on community practices and increasing physician education efforts.

Net product revenue for Jelmyto was $21 million, slightly down due to a one-time unfavorable adjustment and increased competition from clinical trials in the low-grade UTUC space. UroGen Pharma updated its full-year Jelmyto revenue guidance to approximately $90 million.

UroGen Pharma submitted a New Drug Application for UGN-103, with the FDA accepting it for review and assigning a PDUFA goal date of June 14, 2027.

The company announced a strategic collaboration with Intragel Therapeutics to explore the development of oncology products using Intragel’s technology.

Research and development expenses increased to $26 million, reflecting continued investment in clinical development programs, while the company maintains confidence in achieving profitability by the end of 2026.

The company is not issuing full-year guidance for Zesturi, but expects quarter-over-quarter revenue growth.

Full Transcript

OPERATOR

Third quarter 2026 earnings conference call. Currently, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. To remove yourself from the queue, you may press star 11 again. I would now like to hand the call over to Vincent Perrone, Senior Director of Investor Relations. Please go ahead.

Vincent Perrone (Senior Director of Investor Relations)

Thank you. Good morning, everyone, and welcome to UroGen Pharma’s third quarter 2026 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 September 30, 2026. The release can be accessed on the Investors portion of our website at investors.urogen.com. Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; and Chris Degnan, Chief Financial Officer.

On today’s call we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to Zesturi and Jelmyto, our ongoing and planned clinical trials and nonclinical studies, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data, regulatory filings and decisions, the importance of Zesturi’s growth for UroGen’s long-term strategy, anticipated benefits of our strategic collaboration with Intragel Therapeutics, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals and 2026 financial guidance, among other things.

These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements. I’ll now turn the call over to Liz Barrett, Chief Executive Officer.

Liz Barrett (Chief Executive Officer)

Good morning, and thank you for joining us. Today we delivered another quarter of strong execution, with Zesturi generating $68 million in net product revenue, representing a 35% sequential quarter-over-quarter growth. More importantly, the underlying commercial trends continue to strengthen, with increasing repeat utilization, broader physician adoption, and continued expansion into community practices. Together, these trends reinforce our confidence that Zesturi is scaling successfully and establishing a strong foundation for sustained growth.

This momentum reflects Zesturi’s differentiated value proposition. As the first and only FDA-approved medicine for adults with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer, Zesturi offers a primary, surgery-free alternative for disease that historically has been managed through repetitive surgical interventions. We believe this differentiated approach provides patients an opportunity to have more recurrence-free and treatment-free living and is increasingly changing how physicians think about treating these patients.

Turning to the operating metrics we have been tracking, as of September 30, 2026, we had over 1,500 activated accounts. With a substantial foundation of activated accounts now in place, our commercial team’s focus is shifting toward driving utilization within these practices, converting new prescribers into repeat users, and expanding adoption across the broader physician community. Unique prescribers grew to 662 compared with 452 in the second quarter, while repeat prescribers increased to 331 compared to 204 at the end of the prior period.

Repeat prescribers now represent 50% of total writers, up from 45% in the second quarter and 40% in Q1. We continue to view repeat utilization as one of the strongest indicators of sustained adoption. As physicians gain experience with Zesturi’s clinical profile, reimbursement process, and administration workflow, they become increasingly comfortable incorporating the product into routine practice. We believe this growing familiarity and confidence will deepen utilization over time.

We continue to see encouraging adoption trends across community urology practices, with the site-of-care mix remaining relatively consistent with the second quarter and community practices accounting for the majority of the utilization. This reflects the progress we’ve made in expanding our presence in the community setting, where approximately 70% of our addressable market resides. We believe continued growth and deeper penetration within these practices represent a significant opportunity to sustain momentum as the launch continues.

We are also expanding demand-generation efforts through physician education, peer-to-peer programs, and patient awareness initiatives. Many patients living with recurrent low-grade non–muscle invasive bladder cancer remain unaware that a surgery-free treatment option is available. We believe direct-to-patient efforts can encourage more informed discussions between patients and providers, while peer-to-peer programs may help physicians gain confidence from colleagues with firsthand experience using Zesturi.

Together we expect these investments to support broader adoption and help realize the significant commercial opportunity ahead. During the third quarter, we did observe some anticipated summer seasonality for a short period but bounced back quickly, as reflected by the strong quarter results. Importantly, continued growth in new prescribers and patient starts more than offset these seasonal dynamics, reinforcing the underlying strength of demand.

Looking ahead to the fourth quarter, we remain mindful of typical holiday-related slowdown but continue to see opportunities to expand adoption and utilization and expect quarter-over-quarter revenue growth. Turning to Jelmyto, net product revenue was $21 million in the third quarter compared with $22 million in the second quarter. Importantly, this included a one-time unfavorable gross-to-net adjustment of approximately $1.5 million related to the CMS discarded drug provision true-up. We are also seeing increased competition for eligible patients from ongoing clinical trials in the low-grade UTUC space, including our own UGN-104 Phase 3 trial, which has created some headwinds for patient starts.

Nevertheless, Jelmyto remains an important surgery-free treatment option for patients with low-grade UTUC and continues to support our broader commercial infrastructure. Turning now to the pipeline, we achieved an important milestone with UGN-103, our next-generation investigational therapy for adults with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer. Following our NDA submission in August, the FDA accepted the application for review in October and assigned a PDUFA goal date of June 14, 2027, representing another significant step toward potential approval. UGN-103 is a central component to our longer-term strategy.

It is designed to build on the clinical and commercial foundation of Zesturi, while offering potential manufacturing and operational efficiencies that can further strengthen our business over time and opportunities to expand into other non–muscle invasive bladder cancer populations. Importantly, our newly issued patent, now listed in the FDA’s Orange Book, is expected to provide patent coverage into July of 2044 for both Zesturi and, if approved, UGN-103 for the treatment of low-grade, intermediate-risk non–muscle invasive bladder cancer without a TURBT.

We believe this further strengthens the long-term revenue potential for both products. Beyond the initial indication, our planned expansion into high-grade NMIBC with UGN-103 represents an additional opportunity to broaden our reach and address unmet needs in uro-oncology. As part of our lifecycle management strategy for UGN-103, we also plan to initiate a non-registrational trial evaluating its use as an adjuvant therapy in the newly diagnosed intermediate-risk population. Mark will discuss the regulatory and clinical plans in greater detail shortly.

Finally, in August we announced a strategic collaboration, licensing option, and equity investment agreement with Intragel Therapeutics, representing an exciting expansion of our innovation and growth strategy. The agreement provides access to Intragel’s biodegradable sustained-release platform and gives us the opportunity to develop up to three new oncology products using this technology, while also securing an exclusive option to acquire worldwide rights to their cisplatin gel-based, Phase 2–ready therapy for advanced head and neck cancer.

Importantly, this collaboration expands our capability beyond uro-oncology while remaining aligned with our core expertise in localized sustained drug delivery. We believe it creates meaningful opportunity to broaden our pipeline, advance innovation across additional solid tumors, and support future growth. In closing, the progress we made through the first nine months of 2026 has strengthened our confidence in the opportunity ahead. Zesturi continues to scale, our next-generation programs are advancing toward important milestones, and we are investing in a pipeline that we believe can support multiple drivers of future growth. We are building a company positioned for sustained growth through commercial execution, lifecycle expansion, and continued innovation.

With over $90 million in cash on the balance sheet at quarter end, we remain confident in our ability to reach profitability with our existing capital resources. Above all, our strategy remains grounded in our commitment to patients and the belief that they deserve better treatment options. We see tremendous opportunity to build on our success in uro-oncology, expand our reach into additional specialty cancers, and create meaningful long-term value for our shareholders.

With that, I’ll turn the call over to Mark for a clinical update. Mark

Mark Schoenberg (Chief Medical Officer)

Thank you, Liz, and good morning, everyone. I’d like to begin by building on Liz’s discussion on how Zosturi adoption is evolving, particularly as physicians gain experience and increasingly incorporate the product into routine clinical practice. From a clinical perspective, what makes Zosturi particularly compelling is that it offers a fundamentally different approach to managing adult patients with recurrent low-grade, intermediate-risk NMIBC. It is the only FDA-approved primary therapy in this setting and, unlike other therapies currently in development, it does not require TURBT as part of the treatment regimen.

For patients who have historically faced repeated surgeries under general anesthesia and prolonged treatment courses, the ability to achieve durable disease control without another TURBT represents a meaningful advancement. This distinction becomes increasingly important as the treatment landscape evolves. Many investigational therapies are being evaluated as adjuvant treatments following TURBT, often requiring additional induction and maintenance therapy over extended periods.

Zosturi, by contrast, offers a primary, surgery-free approach with a defined six-week treatment course and no maintenance. From a clinical perspective, we believe the ability to deliver durable disease control while reducing the need for repeated surgical interventions and prolonged treatment courses represents a meaningful advantage for both physicians and patients. One of the more encouraging trends we’re seeing is how physician confidence grows with experience. Physicians often begin by treating a small number of patients, and as they observe clinical benefits and see how readily Zosturi integrates into practice, they begin considering it for a broader range of appropriate patients.

Familiarity with the reimbursement process provides additional reassurance, particularly for practices less experienced with buy-and-bill therapies. In some practices, that experience is also being shared among colleagues, supporting broader adoption across the group. From my perspective, this is an important indication that Zosturi is becoming more firmly integrated into the management of recurrent low-grade, intermediate-risk NMIBC. Turning briefly to Jelmyto, we recently announced the publication of final five-year follow-up results from UroGen Pharma’s Phase 3 OLYMPUS trial in Therapeutic Advances in Urology, further reinforcing the long-term durability of response with Jelmyto in patients with low-grade UTUC. Among all 41 patients who achieved a complete response, the median duration of response was 47.8 months. Of the 20 patients who entered the long-term follow-up study, 75% remained event-free at the last assessment with a median follow-up of 53.3 months.

Notably, the median duration of response had not been reached in this subgroup, and no progression to high-grade disease was observed. These findings further reinforce the clinical value of Jelmyto as a kidney-sparing, surgery-free treatment option. Turning now to our clinical development programs, as Liz mentioned, the FDA accepted our new drug application for UGN103 and assigned a PDUFA goal date of June 14, 2027. This represents an important milestone as we advance our next-generation mitomycin formulation toward potential regulatory approval. The application is supported by results from the Phase 3 UTOPIA trial, which are generally consistent with the three-month complete response and six-month duration of response observed with Zosturi in the pivotal ENVISION trial.

From a clinical perspective, the consistency of these results is highly encouraging and supports our confidence in the potential of UGN103 to preserve the durable treatment profile established with Zosturi. We plan to supplement the submission with updated 12-month duration-of-response data as they become available, and we’ll share those results in a future announcement. If we receive FDA approval in 2027, we intend to apply for a permanent J-code by the July 1st quarterly submission deadline, which would position us for a January 1st, 2028 effective date.

We anticipate initiating a full commercial launch in 2028, assuming receipt of the permanent J-code. Beyond the initial indication, we are advancing a broader clinical development strategy for UGN103, beginning with high-grade NMIBC. High-grade NMIBC presents a distinct clinical challenge with greater risk of recurrence and progression and a continued need for effective bladder-preserving options. Following productive discussions with the FDA, we plan to initiate a randomized Phase 3 trial in the fourth quarter evaluating UGN103 as adjuvant therapy in patients with recurrent papillary-only high-risk non–muscle-invasive bladder cancer who have previously received BCG therapy.

The study will compare TURBT followed by either UGN103 or gemcitabine induction and maintenance therapy. We believe this study represents an important opportunity to evaluate whether sustained local delivery of mitomycin in RTGel can provide a meaningful clinical benefit in a more challenging patient population. As part of our lifecycle management strategy for UGN103, we also plan to initiate a non-registrational trial evaluating its use as adjuvant therapy in the newly diagnosed intermediate-risk population.

This study will allow us to further characterize the safety and clinical activity of UGN103 in an additional treatment setting and inform our broader development strategy. Turning to UGN104, our next-generation investigational mitomycin formulation for low-grade UTUC, the Phase 3 trial continues to progress and we expect to complete enrollment by the end of the year or in early 2027. Additionally, UGN501, our investigational next-generation oncolytic virus for high-grade NMIBC, received FDA clearance of our IND in July, enabling us to initiate our Phase 1 clinical trial. The first patient has now been dosed, and we anticipate initial clinical data in 2027.

Our Phase 1 study will evaluate intravesical administration in an aqueous formulation with a primary focus on safety, tolerability, and dose selection, while also looking for early evidence of clinical activity. In parallel, we are developing a formulation incorporating our RTGel technology. We believe sustained local delivery may offer several potential advantages, including prolonged exposure at the tumor site and the opportunity to explore whether pre-treatment requirements such as a detergent wash, dosing intervals, or dose levels can be optimized.

These potential benefits will require further evaluation as development progresses. UGN501 represents an important opportunity to expand our therapeutic capabilities beyond chemotherapy, initially within uro-oncology and potentially into other solid tumors. Finally, I’d like to briefly expand on the strategic collaboration with Intragel that Liz referenced. Our RTGel technology has demonstrated the ability to provide sustained local drug exposure within the urinary tract. However, because RTGel is not biodegradable, its applications are generally best suited to anatomical environments where formulation can be naturally voided. Intragel’s SRGel platform offers a complementary approach. It is a biodegradable sustained-release platform designed to maintain high concentrations of a therapeutic agent directly at the tumor site following a single administration while limiting systemic exposure.

We believe this technology complements our existing expertise in localized drug delivery and broadens our innovation capabilities beyond RTGel. The first clinical application of that platform is a cisplatin gel–based intratumoral injection, a Phase 2–ready investigational therapy for advanced head and neck cancer. Early Phase 1b data presented at ASCO demonstrated encouraging tolerability, low systemic cisplatin exposure, and preliminary evidence of antitumor activity, including in patients with cisplatin-resistant disease.

While these findings remain preliminary, they provide an encouraging foundation for further clinical development. This collaboration expands our pipeline beyond uro-oncology while remaining closely aligned with our scientific expertise in localized, sustained drug delivery, which we believe creates meaningful opportunities for further innovation. And with that, I’ll turn the call over to Chris to review our financial results.

Chris Degnan (Chief Financial Officer)

Thank you, Mark, and good morning, everyone. Total revenue was $89 million in the third quarter of 2026 compared with $27.5 million in the third quarter of 2025. This increase was driven by the continued commercial launch of Zosturi. Research and development expenses were $26 million in the third quarter of 2026 compared with $14 million in the same period last year. The increase was primarily attributable to an increase in UGN103 and UGN104 clinical development costs, the PDUFA fee related to the UGN103 NDA submission, and increased development costs related to UGN501. Selling, general and administrative expenses were $47.2 million in the third quarter of 2026 compared with $37.6 million in the same period last year.

The increase was primarily attributable to increased commercial spend related to the ongoing Zosturi launch. We recorded non-cash financing expense related to our prepaid forward obligation to RTW Investments of $4.5 million in the quarter compared with $4.6 million in the third quarter of 2025. Interest expense on our long-term debt was $4.8 million compared with $3.4 million in the same period last year. The increase in interest expense was primarily attributable to the $75 million of additional borrowings drawn in the first quarter of 2026 in connection with the Pharmakon refinancing, offset by the lower interest rate.

Net loss in the third quarter was $1.5 million, or $0.03 per basic and diluted share, compared with a net loss of $33.3 million, or $0.69 per basic and diluted share, in the third quarter of 2025. As of September 30, 2026, we had $90.5 million in cash, cash equivalents and marketable securities. I would highlight that our cash burn in the quarter included the one-time $4.8 million PDUFA fee associated with the UGN103 NDA submission and a $4 million investment into Intragel related to our strategic collaboration.

With our current cash, cash equivalents and marketable securities, together with $117 million in accounts receivable as of September 30, 2026, we remain confident in our ability to fund the business through profitability with our existing capital resources. Based on our current expectations, we anticipate achieving profitability and generating positive cash flow in the fourth quarter of 2026. Turning to guidance, we are updating our full-year Jelmyto net product revenue guidance to approximately $90 million. This primarily reflects the $1.5 million unfavorable one-time gross-to-net adjustment Liz mentioned, together with headwinds from ongoing competitive clinical trial enrollment in low-grade upper tract urothelial cancer that has affected Jelmyto patient starts. As we have noted previously, we are not issuing full-year Zosturi guidance while the launch is still in its early stages.

We are maintaining our full-year operating expense guidance of $260 million to $270 million, including $20 to $24 million of non-cash share-based compensation. We now anticipate operating expenses to land toward the upper end of the guidance range. This guidance reflects our investment in Zosturi healthcare professional education and patient awareness, start-up activities for the UGN103 high-grade trial, and development activities to explore UGN501 with our RTGel technology.

That concludes our prepared remarks. We will now open the call to questions.

OPERATOR

Thank you. As a reminder, to ask a question you will need to press Star 11 on your telephone to remove yourself from the queue. You may press Star 11 again. Please stand by while we compile the Q and A roster. Our first question comes from the line of Leland Gersho of Oppenheim. Your line is open, Leland.

Leland Gersho (Analyst)

Great. Good morning, everyone. Thanks for taking our questions. Just two from us. First, we just want to drill in a bit, Mark, on your comments about, you know, sort of the type of patient who would be the go-to for Zosturi versus another TURBT. It sounds like, you know, given the data, Zosturi can treat, you know, a fairly broad range of such patients, but perhaps urologists are a bit more narrow. Could you sort of share with us kind of what that looks like in terms of their preference now versus what the data have shown?

And then I’ll have a follow-up.

Mark Schoenberg (Chief Medical Officer)

Sure. So thank you, Leland. What we’re seeing urologists do right now is, as Liz mentioned and as I’ve said on multiple calls before this one, is get familiar with the drug. The data support using this in patients with a recurrence or maybe two recurrences. In fact, that’s what we studied. But truthfully, the drug is appropriate for a patient who has recurred after standard of care with intermediate-risk, low-grade disease. So in terms of the appropriate population, it would be appropriate for patients who’ve recurred after standard of care, which would be TURBT and then, based on guidelines, possible use of intravesical postoperative therapy. So anybody who’s recurred with low-grade disease could receive the drug.

But again, what we’re seeing is the doctors are getting familiar, so they’re using it in patients who’ve had more than a couple of TURBTs. And I would imagine what will happen is, as they gain greater familiarity with this, they will move it to earlier in the line of therapy for this population. Liz and Chris may also want to have comments based on their understanding of the commercial launch. Thanks, Leland. Sounds like that’s the answer.

Leland Gersho (Analyst)

Okay, thank you. And also just curious, given that 3Q could have seen some seasonal weakness or softness in terms of visits and procedures, just wondering if there’s any way to either quantify or give color around how much that could have impacted Zosturi despite obviously the continued growth. Thank you.

Chris Degnan (Chief Financial Officer)

This is Chris. So just on this, it’s tough to quantify. I mean, what we did see, seasonality, as Liz mentioned, it generally impacted, if we just look at the pace of new patient enrollment forms during the summer months. But the momentum from Q2 patient enrollments and therefore patients on therapy coming into the quarter, plus just the continued growth in new and repeat prescribing, more than offset those dynamics, which contributed to another strong quarter in terms of revenue.

So it’s really hard to quantify the true impact there. But as we said, we saw a bit of it there.

Liz Barrett (Chief Executive Officer)

Yeah, hi, it’s Liz, and I apologize because I’m not in the room with the team, and so I want to go back, Leland, to your previous question, though—when Mark answered, I couldn’t get off of mute fast enough. But I’ll answer that question first. I don’t think that if you think about pure revenue that it impacted it that greatly because of the way we bounced back pretty quickly. So because PEFs and new patient starts are fairly variable anyway, I don’t think we lost a lot of patients, if that makes sense.

So while we did see a leveling of PEFs for a couple of weeks, it came right back. And because it takes several weeks anyway for these patients, I would say that it didn’t have a huge impact on revenue. So maybe minimal, but not huge. Going back to Mark’s, though, I want to be really clear. We actually are seeing in the claims database—we’re seeing usage across the board. So not just—I think what we’ve said from the beginning is we expected that physicians will start with their more heavily pretreated patients, but they very quickly get to all of their patients. And we’ve seen that in the claims database where we’ve seen the shift to physicians using it after one and after two.

And so it’s a pretty even group of patients. Like I said, after one, after two. Yeah, you see the ones after three, after four, after five—we’ve got patients, as we’ve talked about before, after 20 and after 40 TURBTs. So it is across the board, but any physician is going to likely start with their more heavily pretreated patient, but adopt it across the board. And we’re still seeing that. And that’s what we’re hearing also from physicians as we’re out there talking to physicians.

So hope that helps. And my apologies for being delayed.

Leland Gersho (Analyst)

Absolutely. Thank you very much. Very helpful.

OPERATOR

Thank you. Our next question comes from the line of Sara Bancroft of TD Cowen. Please go ahead, Sara.

Sara Bancroft (Analyst)

Hi, good morning, and congrats on this great quarter. I know that it’s challenging to predict going forward, but I’m curious, even based on your years of experience with Jelmyto, if maybe we should expect these types of trends that you saw in Q3 to be the norm going forward each year, or maybe if there were any effects that are unique to the early stages of the launch, maybe you could tell us about that. And then also looking forward to Q4, if you could maybe talk about any impacts that we can expect then that could potentially offset demand growth.

Just what to expect there in the near term and long term. Thanks.

Chris Degnan (Chief Financial Officer)

Yeah. So, Tara, this is Chris. I’ll start and then Liz, you can jump in just in terms of the Q3 dynamics. And I think just Jelmyto is not a great analog here, Tara—just mainly, one, just the sheer number of patients, right, in terms of Zosturi market opportunity is much larger. And so coming into the quarter, we anticipated some seasonality as we talked about, but were confident that just given the number of available patients, that would more than offset any potential seasonal impact, which we saw.

So I think this is part of it as we think about the Zosturi guidance—wanted to get through some of these quarterly dynamics just to better understand kind of the magnitude and what this looks like. So hard to predict exactly what this would look like on a recurring basis, but still in the early stage of launch, think that there’s obviously opportunity for continued quarter-over-quarter growth momentum here. So coming on your point then around Q4, you know, we do continue to expect to see, you know, quarter-over-quarter revenue. We’re encouraged by the trends we’re seeing in terms of the number of new prescribers within Q3 as well as the percentage of those prescribers who become repeat writers. So, you know, we are mindful, as Liz mentioned in our remarks, that, you know, there could be some typical holiday-related seasonality in Q4. We have, you know—we did see it a bit even in the early stages with Zosturi launch last year where the weeks of the holidays, you know, you can have fewer patient starts and doses shipped.

But overall, you know, we do expect continued growth, and we are comfortable with where consensus sits for the full year for Zosturi.

Sara Bancroft (Analyst)

Okay, sounds great. Thanks.

OPERATOR

Thank you. Our next question comes from the line of Raghuram Sovaraju of HC Wainwright company. Your line is open, Raghav.

Raghuram Sovaraju (Analyst)

Thank you. Thank you so much for taking our questions. I was just wondering if we could maybe start with Jelmyto—if you anticipate that there is likely in the long run to remain some incremental quarter-over-quarter growth potential for the product, or if at this juncture you’re seeing any indications of market saturation.

Liz Barrett (Chief Executive Officer)

Hey Chris, I’ll take that. Hi Ram, it’s Liz. I think what we’re doing, and I think it’s fair to say that Jelmyto, like every other product that I’ve ever been familiar with, is promotion sensitive. And so what we’re doing is we are developing sort of a strike team to go into sort of our heavy users of Jelmyto to ensure that we maintain that promotional share of voice in there. Having said that, we really did get hit with the clinical trials. I have to be honest with you, I’m very surprised that you’ve got about four, four or five companies right now doing studies in this low-grade UTUC space with a very limited patient population. And our heavy users are also clinical trial sites. So if you sort of annualized—if you annualize—it’s several million dollars of revenue. Not saying that we would have gotten all of that.

But if you think about it, so I guess my point is going to be, yeah, once we get past this hump. Now, granted, there’s still going to be clinical trials in 2027, so you’ll still continue to have that headwind there. But I do think that there’s opportunity to get back on track with Jelmyto in the sense of our trial will be fully enrolled—our UGN-104 trial. So as we—that’s one that will be done. And as they start to end, I think you’ll see that. And then I do think that adding some promotional muscle back behind Jelmyto specifically. And look, we prioritized Zosturi, we made that decision and, you know, we knew that there was a potential that, you know, that Jelmyto would have challenges. I think our hope was that with the incremental physicians you would see some of that come back. But, you know—and as we talked about with the $1.5 million hit from there—so we’ve had a few headwinds there, but still think that there’s a lot of opportunity on Jelmyto.

But what we’ve said, you know, it’s likely to be around a $100 million opportunity as we get into UGN-104. There may be some opportunity there that could draw that a little bit higher than that. But, you know, we’ve always talked about the fact that we felt like, you know, within that 100 to 150 range is likely to be where Jelmyto will be long term.

Raghuram Sovaraju (Analyst)

And then with respect to the Zosturi franchise, just two items here. I was wondering if you could comment on the prospects regarding kinetics behind expansion of the total complement of activated sites of care, and if you anticipate that there might be potential to see an inflection point on that front either before the end of this year or sometime during the first half of 2027. Also, if you could maybe comment on the trend with respect to percentage of repeat prescribers as a percentage of the total prescribers going forward, and if you anticipate that there might be the likelihood of that percentage ticking up meaningfully above the 50% level.

And with respect to the 103 application, if there has been any indication from the reviewers of that application that they want to see additional controlled data or if really what they are looking for is simply confirmation of the durability of response rate at the 12-month cutoff. And then lastly, I just wondered if you could briefly comment on what you are looking for to trigger the exercise of the option in the Intragel agreement on their cisplatin candidate.

Thank you.

Liz Barrett (Chief Executive Officer)

Chris, you want to start? Yeah. So let’s—I’ll start with the activated sites and a little bit around the prescriber rate and then maybe turn it over to Mark on the 103 question and then to you for the Intragel piece. So just, Ram, on activated sites, you know, we’ve done a good job of, you know, building a substantial foundation there in terms of activated sites, and we’ll continue to add them. And it can be a bit lumpy, as you’ve seen. I mean, we added quite a few activated sites in Q2, maybe fewer in Q3.

But the team’s really been focused on driving and converting those accounts into prescribers. And so I think really the focus has been and should be the focus in terms of KPIs is looking at our new prescribers as well as looking at what that repeat utilization rate is. And we still believe there’s substantial opportunity here to expand adoption within the existing account base that we’ve already set up. But we will continue to add accounts as we go.

In terms of the repeat prescriber rate, again, that’s a rate that we look at because as Mark mentioned, typically what urologists are doing is trying Zestoria on one or two patients, understanding the reimbursement dynamics, how it incorporates in their operational workflow, looking at the clinical experience and then starting to use it on additional patients. And so looking at how that repeat prescriber base evolves over time is a really important focus for us.

And so part of it is how fast you fill the top of the funnel in terms of new prescribers, which we’re really pleased with, how that’s tracking in terms of performance in Q3, but then also expanding that repeat writer base. And so we would expect the number of repeat writers, as they get experience with the story, to continue to grow as well.

Mark Schoenberg (Chief Medical Officer)

Ron, thanks for the question about 103. We’ve not received any additional information from the FDA suggesting that they want comparative data or anything other than what we had originally proposed, namely complete response, safety, and then obviously the update with the 12-month durability data. So we are still on track with our original proposal and there hasn’t been any change in that to date.

Liz Barrett (Chief Executive Officer)

Yeah, and look, I’m just going to comment a little bit more around your question around can it accelerate and can you have an inflection point? I don’t think you’ll see an inflection point in the next few quarters. Right. I think there’s two things, and we’ve talked about this a little bit before, that could cause an inflection. One, we’ve talked about DTC. We are going all in on DTC in 2027. That takes time. So it’s not likely to be before kind of mid-year 2027.

And I do think that that can be a real driver and inflection point for us. And the other is, to your point, you’ve got to get a lot of large group practices and these community practices where most patients are to really implement kind of a bladder line of service. What do I mean by that? And, you know, they talk a lot about patient navigators, having these bladder champions where they go and they’re actually actively looking for patients. And I think when you do get to enough of a breadth of those types of practices, then you can see kind of an inflection point.

You know, we always—we think about bladder cancer every day. But urology practices, it’s only about 20% of their practice. Right. So they’ve got a lot of other things on their mind. So these types of things take time. But in all of our conversations with these large practices, they get not only the clinical benefit, but they also get the practice benefit to doing this. And so we are hearing—we continue to hear—very positive feedback about their intention to use ASTRU and their intention to continue to drive that depth of usage in their practice.

And today, yeah, I mean, we talk about we’ve grown our number of users, but the reality of it is that that’s still a very small percentage of the total urologists. So what is driving our revenue today is the depth of those users. So that’s why we have to get the breadth and the depth in those. So like I said, what’s driving more today is more that depth. And yes, we do expect that more and more—more than 50%—that will continue to grow as we, you know, they’re, quote unquote, repeat users.

We don’t see any kind of one and done. And we’ve talked about all of our research. 100% of physicians who have used it said they’d use it again. And we know that patients are really happy with it. So when those all things come together, we expect to continue to see growth. On the Intragel, basically, we need to see positive data in their phase two study. And that’s when we would discuss whether it makes sense for us to take that forward. So that’s really what we would be looking at for the Intragel. It’s a similar approach and so one that we’re quite familiar with. We like the data we’ve seen so far, but we need to see more data before we would decide to take an option on that. So hope that helps, Ram.

Raghuram Sovaraju (Analyst)

Yes. Thank you very much.

OPERATOR

Thank you. Our next question comes from the line of Kelsey Goodwin of Piper Sandler. Your line is open. Kelsey,

Kristin (Analyst)

Hi, this is Kristin on for Kelsey. Thanks for taking your question. Just a couple of quick ones. So what factors are most important to drive acceleration as we move into years two and three of the launch of this jury? And what is most important when trying to broaden the number of unique prescribers? Thank you,

Chris Degnan (Chief Financial Officer)

Liz, I’ll start and you can weigh in. Thanks, Kristin, for the question. Liz mentioned in prior remarks just in terms of what could generate acceleration going forward. I think the two main factors that we would point to is, one, patient activation. As we talked about, looking to invest in that more heavily in 2027. And so patients coming in and asking for non-surgical approach we think can contribute towards an acceleration. As Liz said, that’s also going to take some time.

So we’re developing that program and we’ll look to roll that out in earnest in the mid part of next year. Then the other piece goes back to the protocol establishment at some of these large group practices where really driving Sistori, you know, kind of first in terms of how they think about utilization within their group practices. In terms of the unique prescriber piece—you know, look, as Liz said as well—we’re still in the early stages of that. And so if you just think about, we talked previously that our broad target universe is over 8,000 urologists.

Our core target, so deciles 2 through 10, is roughly 6,500 urologists. And through Q3, you know, we just have over 10% of those urologists having prescribed Systori. So there’s plenty of opportunity for us to really continue to drive the breadth of utilization. And that’s, you know, what we’re focused on every day in terms of, you know, getting that—you know, our sales force out there, you know, make sure they have clinical conviction, getting them to try the product.

And we know urologists are a bit slower and more methodical in adopting new products. So, you know, getting them out there, getting comfortable with the reimbursement profile and the operational dynamics of this is, you know, obviously a key part of our strategy.

Kristin (Analyst)

Thank you. And just one quick follow up. What is the split currently of the story being used as a primary therapy versus an adjuvant.

Liz Barrett (Chief Executive Officer)

Yeah, so it’s Liz. Right now—and this is, look, just as anecdotal and through our claims database, so it’s, you know, just take it for what it’s worth. Right. We don’t have quantitative and we don’t capture that information—but it looks like over 60% is primary and we have seen that increase. So again, initially maybe some doctors said, let me do the—I want to do the TURBT first and then come back with it. And we’re seeing more and more doctors being more comfortable with primary treatment, which is what we think is what we should do.

And that’s what we talk about and that’s what we promote. And so we think that’s in the best interest of the patient. So you’re seeing now the amount of adjuvant decline to a little bit less than 40%.

Kristin (Analyst)

Great. Thank you so much.

OPERATOR

Thank you. Our next question comes from the line of Michael Schmidt of Guggenheim Securities. Your line is open. Michael.

Michelle (Analyst at Guggenheim Securities)

Hi, this is Michelle on for Michael. Thanks so much for taking our question. Just a question on the UGN103 transition. With the plan to submit the 12-month durability data for FDA review, do you see this durability update changing the label? And then also, how long do you expect there to be an overlap between the transition from Zosturi to UGN103 before the unique J code? Thanks,

Mark Schoenberg (Chief Medical Officer)

Yeah. With respect to the durability data, we obviously think that the 12-month durability data will be incredibly important to the label, as it was with CIS3. So it’s an important update, but it won’t change the timeline of review. And then I’ll defer to Chris.

Chris Degnan (Chief Financial Officer)

So just in terms of the transition. So the plan is right now, with PDUFA date being mid-June, to submit then for the J code by the July 1 submission date, which should position us for an effective date of January 1, 2028. And then, you know, at some point during ’28, you know, we do have, you know, flexibility here in terms of just given, you know, the additional IP that we have for Zesturi as well, to be thoughtful and mindful about the transition.

And so our plan is, you know, in 1H28, then to introduce 103 into the market, and there will be a period of time where both products will be available to make sure that it is a seamless transition, that all patients ultimately get therapy. So I would expect several months over the course of ’28 for both products to be on the market, and then at one point where we have the majority of patients moved over, we will pull the story from the market.

Michelle (Analyst at Guggenheim Securities)

Great, thank you.

OPERATOR

Thank you. Our next question comes from the line of Amin Makaram of Jefferies. Your line is open. Amin,

Chris Degnan (Chief Financial Officer)

I’ll start with the linear growth question. We’ve said, even coming into the start of the year, that given the way urologists adopt new products, we saw this more as a steady linear growth trajectory. If you think about the quarterly dynamics, you mentioned the 20 million, which was the absolute growth between Q2 and Q1. Q1 grew about 15 million, and this past quarter grew about 18 million. So we do expect a general linear growth trajectory, but there’s going to be some quarter-to-quarter variability.

Thinking about it in the framework of growing 15 to 20 million this year, and as we think about Q4, we expect continued growth and we’re comfortable with where full-year consensus currently sits versus 30. You’re trying to factor in those quarterly dynamics at play. For the trajectory in ’27, we’re not issuing guidance at this point for Zosturi and haven’t really provided much in terms of context for the ’27 outlook, but we think about a steady growth rate, and I think that range is reasonable.

There may be opportunities to accelerate that growth rate in a future period. As we think about the 103 program, maybe I’ll turn it over to Mark to talk about how we’re looking at that.

Mark Schoenberg (Chief Medical Officer)

Thanks for the question about that. The purpose of the adjuvant trial in the newly diagnosed is specifically to provide physicians—who we already know are, in some patients, using Zosturi as an adjuvant and presumably would also use 103 as an adjuvant in select patients—with safety and tolerability information. Remember, we primarily study patients using Zosturi 102 and 103 as a primary therapy. But we know that some doctors in the community are using primary chemoablation actually after, as an adjuvant therapy.

So again, the goal is safety and tolerability. We would obviously report any efficacy information as well as part of that trial. This is, as you noted, not a registrational trial, so we would not be planning on changing the label based on these data. But I would defer to Liz as to whether or not she thinks this would impact guidelines.

Liz Barrett (Chief Executive Officer)

I think that there definitely will be enough information and enough data when you combine it with our ATLAS study. Whether we’ll get in the guidelines or not, I don’t know; I can’t really comment on that. That’s not really our goal. As Mark said, the objective is to ensure that physicians understand the data, because we haven’t generated data in that specific patient population. I think it’s really important, and we already know, as Mark commented, that some docs have actually already used it that way.

So we want to make sure that there’s data generated in that space, and that’s the goal. And look, if it’s really, really strong data, who knows—maybe we will go back and do a registrational study after that. But the purpose is really to ensure that there’s some data generated in that patient population, which is really the only patient population in the low-grade IR space that we haven’t studied. We would absolutely submit the data—both the results of this study along with our ATLAS data—and have published data around that so that physicians would have access to it.

OPERATOR

Thank you. Our next question comes from the line of Kevin Deketter of Ladenburg Thalmann. Your line is open, Kevin.

Kevin Deketter (Analyst)

Hey, great. Thanks for taking our questions. Maybe just three quick ones. With regard to Zosturi commercial metrics, can you comment from an operational perspective what part of the commercial team’s messaging is most effective in transitioning unique first-time users to repeat users? And then, as I think about 2027, any thoughts with regard to headcount expansion in the commercial team, specifically around Zosturi, and what sort of impacts the timing of turning on a DTC program for Zudori, potentially in 2027?

Chris Degnan (Chief Financial Officer)

Liz, I’ll start with the headcount expansion and timing on DTC, and then you can comment around what messaging we find is most effective. In terms of headcount expansion, Kevin, we feel like we are well positioned with the number of reps that we have out there currently promoting Zestory. We have roughly about 80. When you factor in the field reimbursement managers, operations managers, key account directors, and nurse educators to help support the staff and the offices around all the other dynamics that go along with the drug—like Zestory, the reimbursement, the operational piece—our overall customer-facing footprint is about 160 people.

So going into next year, we feel like we’re well positioned to continue to drive the uptake of Zosturi. In terms of DTC and timing, we have to go through all the development, and our marketing team is working on that now. In terms of launching it, it’s more likely going to be around the mid-part of next year before we’re in market with the DTC campaign.

Liz Barrett (Chief Executive Officer)

Sure. When you think about it, I’ll be honest, the most compelling thing is actually the results that they see from a clinical perspective. But we’ve always talked about the fact that the operational lift and the reimbursement lift are the biggest barriers to use. At the end of the day, our team is there to—and Chris talked about all the roles, which is the reason we have all these different roles—to help them operationally. So making sure that they’re set up just to get it from the specialty pharmacy or the specialty distributor.

In the case of the community practices, they want it mixed, so we mix it for them. Really getting it set up in the office is about training, making sure that the doctor’s communicated to the practice that they’ve gone through the administration. There are a lot of different people within an account that you’ve got to get ready. The operational pieces I would say aren’t necessarily a barrier. They take time. The barriers really come down to reimbursement and changing a physician’s mind that they don’t need to do surgery. Those are the two biggest things we continue to hear. Even though we have great reimbursement, there’s this kind of fear of reimbursement and ensuring that they know that they’re going to get reimbursed. That’s why they use it on a couple of patients first and make sure that they get reimbursed—and they get reimbursed at the level that they need to get reimbursed at—before they’re willing to adopt it broader into the office.

So, again, the clinical message—what they’re seeing when they actually use it—is driving them to use it again because they’re seeing that it works, and they’re seeing that they get reimbursed. We just have to continue to knock down those barriers. Unfortunately, there’s not one thing that we can do that overcomes that. You just have to be in that office, and every office is different, so you’ve got to be in there talking to all of the different stakeholders within the practice.

Kevin Deketter (Analyst)

Very helpful. Thanks for taking our questions.

OPERATOR

Thank you. I would now like to turn the conference back to Liz Barrett for closing remarks.

Liz Barrett (Chief Executive Officer)

Thank you. And thanks, everybody, for the great questions. I know every quarter everybody wants us to tell what’s exactly going to happen. What I can tell you is that the excitement that we see and hear when we talk to physicians about the role—whether I’m out there, Mark’s out there—we’re out there all the time talking to docs, and they continue to be very excited and continue to talk to us about how they’re going to adopt it in their practice. That gives us, along with the Q3 results, a lot of confidence that we’ll continue to grow Zisteri and that we’ll continue to see our path to the $1.2 billion peak that we’ve talked about in the past.

Also excited about all of the progress that we’re making in our pipeline—advancing 103 and life-cycle management into other spaces and really starting to get data on UGN-501. It’s an exciting time for our company. And Chris talked about the fact that not only are we in a very good position from a cash perspective, but we expect to hit profitability in Q4. It’s an exciting year for us, and we expect to continue to drive adoption of Zestory, also with Jalmido, and to advance our pipeline.

Really appreciate all the support as we build this long-term sustainable growth company. We’ll keep you posted on all the updates. That ends our call. Thanks. You can disconnect now.

OPERATOR

Thank you. This concludes today’s conference call. Thank you for participating. You may now disconnect.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company’s SEC filings and official press releases. Corporate participants’ and analysts’ statements reflect their views as of the date of this call and are subject to change without notice.