Q2 2025 UroGen Pharma Ltd Earnings Call

August 7, 2025

Any 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 one one on your telephone you will hear an automated message advising you. Your hand is right to withdraw your question. Please press star one one again.

Please be advised that today's conference is being recorded I would now like to go ahead and hand the conference over to your first speaker today, Vincent Perone Investor Relations Vincent you have the floor.

Thank you operator, good morning, everyone and welcome to your Gen Pharma second quarter 2025 financial results and business update conference call.

Earlier. This morning, we issued a press release, providing an overview of our recent corporate highlights and financial results for the quarter ended June 32025.

Press release can be accessed on the investors portion of our website at investors thought your agenda Dot com.

Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, David Lynn, Chief Commercial Officer, and Kris <unk> Chief Financial Officer.

During today's call, we will be making certain forward looking statements. These may include statements regarding our ongoing commercialization activities related to Joe <unk>, our ongoing and planned clinical trials commercial and clinical milestones market and revenue opportunities our commercialization strategy and.

Expectations as well as anticipated data regulatory filings and decisions to dairy being the primary growth driver for you or again, the potential benefits of our products and product candidates future R&D development efforts, our corporate goals in 2025 financial guidance among other things.

The press release can be accessed on the investors portion of our website at investors. Cam.

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.

Joining me on the call today are Liz, Barrett president and chief executive officer, Dr. Mark schenberg chief medical officer, David Lin, Chief commercial officer and Chris Denman, Chief Financial Officer.

You're cautioned not to place undue reliance on these forward looking statements and the origin disclaims any obligation to update these statements.

I'll now turn the call over to Liz.

Thank you Vincent on June 12, we achieved at defining milestone for <unk> with the FDA approval of the story for adults with recurrent low grade intermediate risk non muscle invasive bladder cancer.

This was truly a landmark moment for our company and importantly for that 59000 annual patients in the U S. We think recurrence and repeat surgeries year after year with no approved alternative.

During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing. Commercialization activities related to Joe Mido and Zuri our ongoing and planned clinical trials, commercial and clinical Milestones market and revenue opportunities. Our commercialization strategy and expectations as well as anticipated data regulatory, filings and decisions. This Dury being the primary growth driver for your origin, the potential benefits of our products and product candidates future R&D development experts, our corporate goals and 202.

5 Financial guidance, among other things.

<unk> is the first and only FDA approved pharmacologic treatment for adults with this disease and has the potential to fundamentally change the treatment paradigm and offer patients durable long term recurrence and treatment free living.

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.

Your caution not to place undue Reliance on these forward-looking statements and your origin. Disclaims. Any obligation to update these statements?

I'll now turn the call over to List.

We are proud to be leading that shift.

History is European second commercial product and marks our transition from a rare disease focused company to a scaled multi product organization.

Five years ago, we launched <unk> for the treatment of low grade upper tract <unk> cancer that experienced laid the foundation for everything we're doing today when says dairy we are entering a larger less complex market. The total available market exceeds $5 billion annually and we are well positioned to.

Thank you. Vincent on June 12th. We achieved a defining milestone for your origin with the FDA approval of Zuri for adults with recurrent low-grade intermediate risk, non-muslim invasive, bladder cancer,

Penetrate the opportunity with our expanded sales team of 82 territories as of August one.

Up from 50 previously we have an experienced team with strong knowledge and relationships that will allow us to accelerate and guide the launch of the story.

This was truly a landmark moment for our company and importantly, for the 59000 annual patients, in the US who faced recurrence and repeat surgeries year after year, with no approved alternative. There's Durie is the first and only FDA approved pharmacologic treatment for adults with this disease, and has a potential to fundamentally change. The treatment Paradigm and offer patients, durable, long-term recurrence, and treatment-free living.

We are proud to be leading that shift.

Our commercial organization has a deep understanding of how care is delivered in neurology from academic centers to high volume community practices.

The story is urgent, second commercial product, and marks our transition from a rare disease, focused company to a scaled multi-product organization.

Their established relationships and filled insight position us well for a strong and disciplined launch.

Regarding the commercial launches the story. The initial focus is on setting up sites of care and driving clinical conviction. The team is focused on driving early adoption among urologists, who previously prescribed gum mito and those willing to initiate treatment before a permanent J code is assigned.

This is a disciplined strategic launch built on learnings from our first product as we move to 2026 with broader reimbursement anticipated, we expect our reach to expand significantly David will provide more details on the launch in a few minutes.

5 years ago, we launched John Mido for the treatment of low-grade upper tractor, oil cancer, that experience laid, the foundation for everything. We're doing today with the duree. We are entering a larger but less complex Market. The total available Market exceeds 5 billion dollars annually and we are well positioned to penetrate the opportunity with our expanded sales team of 82 territories. As of August 1st up from 50 previously, we have an experienced team with strong knowledge and relationships that will allow us to accelerate and guide the launch of the story.

Turning to John <unk> I am pleased to report a strong second quarter with net product revenues of $24 2 million.

Volume Community practices.

Their established relationships and filled Insight position as well for a strong and disciplined launch.

<unk>, an 11% increase over the same period in 2024.

<unk> continues to grow with strong underlying demand in the second quarter, demonstrating continued adoption and usage of this important therapy for patients.

The value proposition of Gem Mitre remains clear durable responses backed by long term data and real world use we are pleased with the results and acceptance received by urologists.

Regarding the commercial launches this Dury, the initial focus is on setting up sites of care and driving clinical convictions. The team is focused on driving early. Adoption among urologists, who previously, prescribed young Mido, and those willing to initiate treatment before a permanent J code is assigned.

This is a disciplined strategic launch built on learning from our first product.

<unk> long term goal is to develop and commercialize a differentiated portfolio of treatments that address meaningful unmet needs across your affiliate <unk> and specialty cancers.

As we move to 2026 with broader reimbursement anticipated, we expect our reach to expand significantly. David will provide more details on the launch in a few minutes.

<unk> 301, our anti <unk> monoclonal antibody continues to progress in both monotherapy and combination studies for high grade non muscle invasive bladder cancer.

Turning to John Mido. I'm pleased to report a strong second quarter with net product, revenues of 24.2 million representing an 11% increase over the same period in 2024.

Meanwhile, our next generation pipeline is advancing.

The phase III Utopia trial of <unk> hundred three for recurrent low grade intermediate risk non muscle invasive bladder cancer is now fully enrolled and we expect initial complete response data by the end of 2025.

Joe Mito continues to grow with strong underlying demand in the second quarter, demonstrating continued, adoption and usage of this important therapy for patients.

We will share this data with the FDA and gain agreement on the path forward to approval.

The value proposition of John maider remains clear durable responses, backed by long-term data in real world. Use we are pleased with the results and acceptance received by urologists.

If the trial is successful we expect to file an NDA for this product in 2026.

We've also initiated a phase III trial in June of 2025 for UGI and 104, our next generation <unk> based formulation for low grade <unk>.

Urgent's long-term goal is to develop and commercialize, a differentiated portfolio of treatment that address meaningful unmet needs across Rural and Specialty cancers.

Our balance sheet remains strong with $161 $6 million in cash cash equivalents and marketable securities as of June 30, We believe we have the necessary capital to fund the <unk> launch, while supporting the advancement of our pipeline and other strategic priorities.

Ugn 301 are anti-ctla for monicon. Antibody continues to progress in both monotherapy and combination studies for high-grade non-muslim based of bladder cancer.

Meanwhile, our next Generation pipeline is advancing.

We will be thoughtful about potential opportunities to expand our portfolio for the long term on driving commercial success and profitability goals the.

The phase 3 Utopia trial of UGM 103, for recurrent low-grade. Intermediate risk, non-muslim, based of bladder cancer is now fully enrolled and we expect initial complete response data by the end of 2025.

We will share this data with the FDA and gain agreement on the path forward to approval.

The team at <unk> has demonstrated their dedication and resilience, while striving to make a meaningful impact for patients to neurology community, particularly those participating in research as well as those publicly advocating support for our medicines, we could not do it without you with two.

If the trial is successful, we expect to file an NDA for this product in 2026.

We've also initiated a phase 3 trial in June of 2025 for UGM 104. Our next Generation might of mice and based formulation from low-grade, utuc

<unk> products and advancing pipeline and our commercial infrastructure to scale. Your Gen is well positioned for sustainable growth.

We are executing with discipline and purpose and we remain deeply committed to delivering meaningful innovation for patients and generating value for our shareholders I will now turn the call over to Mark Schoenberg Mark.

Our balance sheet remains strong, with $161.6 million in cash, cash equivalents, and marketable securities as of June 30th. We believe we have the necessary capital to fund this theory launch while supporting the advancement of our pipeline and other strategic priorities.

Thank you Luiz as a practicing urologist I've spent years managing patients with recurrent low grade intermediate risk non muscle invasive bladder cancer.

We will be thoughtful about potential opportunities to expand our portfolio for the long term while driving commercial success and profitability goals.

The team at Urgent has demonstrated their dedication and resilience while striving to make a meaningful impact for patients.

We see the approval of <unk> as a meaningful advancement in how we care for this population for the first time, we can offer patients and their health care providers and effective pharmacologic treatments with targets and the underlying disease and offers a convenient office space outpatient alternative to repeated surgeries we view.

To the Urology Community, particularly those participating in research, as well as those publicly advocating support for our medicines, we could not do it without you. The 2 commercial products in advancing pipeline in the commercial infrastructure to scale, urine is well positioned for sustainable growth.

This is a significant shift in the standard of care.

Historically, <unk> resection of bladder tumor or <unk> as being the only real option for patients with low grade intermediate risk disease.

We are executing with discipline and purpose and we remain deeply committed to delivering meaningful Innovation for patients and generating value for our shareholders, I will now turn the call over to Mark Schamberg, mark.

<unk> is an invasive surgical procedure it requires general anesthesia and access to an operating room and it carries risks, especially in an older population patients are typically diagnosed with bladder cancer in your mid Seventy's and.

Thank you Liz as a practicing urologist. I've spent years managing patients, with recurrent low-grade. Intermediate risk. Non-muslims of bladder cancer.

Many of these patients have comorbidities that make surgery under general anesthesia less than ideal.

We also know this is a highly recurrent disease approximately 68% of patients experienced at least two occurrences and 23% will have five or more.

That means multiple surgeries under general anesthesia in an ongoing burden. It takes a toll on both physical health and quality of life not to mention the burden placed on partners family and other caregivers. In addition repeated few RVP procedures may be associated with an increased risk of mortality.

We see the approval of Zuri is a meaningful advancement in how we care for this population. And for the first time we can offer patients, and their health care providers, an effective pharmacological treatment, that targets the underlying disease. And offers a convenient office-based outpatient alternative to repeated surgeries, we view this as a significant shift in the standard of care

Historically Transit with the reception of bladder tumor or turbt has been the only real option for patients with low-grade intermediate risk disease.

<unk> offers a new non surgical treatment approach.

<unk> is administered as an interim vessel installation of urinary catheter once a week for six weeks in a physician's office no operating room, no general anesthesia and minimal recovery time.

Turbt is an invasive surgical procedure. It requires general anesthesia, and access to an operating room. And it carries risks, especially in an older population. Patients are typically diagnosed with bladder, cancer in their mid-70s. And many of these patients have comorbidities that make surgery under general anesthesia, less than ideal.

In many cases, a trained nurse can perform a procedure right in the urologist office.

Patients. This means a much less disruptive experience for medical practices. It means increased ore availability for more complex procedures and inefficient in office option that can streamline treatment delivery.

We'll have 5 or more.

The clinical data supporting the story are both robust and continuing to mature.

In our ongoing pivotal phase III envision trial, 79% of patients who achieved a complete response at three months. Following the completion of treatment equally important. However is the durability of that response and bladder cancer long term disease control as we're truly improves outcomes and quality of life for patients.

That means multiple surgeries under general anesthesia and an ongoing burden, that takes a toll on both physical health and quality of life, not to mention, the burden, placed on Partners family. And other caregivers in addition. Repeated TBT procedures may be associated with an increased risk of mortality.

The story offers a new non-surgical treatment approach. This story is the ministered as an intravesical installation via urinary. Catheter once a week for 6 weeks in a physician's office. No, operating room. No general anesthesia and minimal recovery time.

Our most recent update from envision, which we shared earlier this week, we announced the 24 month duration of response of 72, 2% by Kaplan Meier estimate for patients who achieved a complete response at three months. After the first installation of this history with.

In many cases a trained nurse. Can perform the procedure right in the neurologist's office.

The sustained response observed offers real value to both patients and practices, allowing management of recurrence with greater confidence in extending the time between recurrences.

For patients, this means a much less disruptive experience for medical practices. It means increased. Oh, availability for more complex procedures and an efficient in-off option that can streamline treatment delivery.

<unk>. The median duration of response has not been reached.

The event rate has not accelerated and remained steady overtime.

And the published literature. The median duration of response for <unk>. In this population is approximately six to nine months with a substantial proportion of patients recurring within the first year.

The clinical data supporting those 3 are both robust and continuing to mature in our ongoing pivotal phase 3 and vision trial. 79% of patients achieved a complete response of 3 months following the completion of treatment equally important. However is the durability of that response in bladder cancer. Long-term Disease. Control is what truly improves outcomes and quality of life for patients.

These results are further supported by the five year follow up data from Phase III Optima II study in <unk>.

Both newly diagnosed and recurrent disease, which was published in the journal of clinical genital urinary cancers. This past June.

In our most recent update from Envision, which we shared earlier this week, we announced the 24-month duration of response is 72.2% by Kaplan Meier estimate. For patients, who achieved a complete response of 3 months after the first installation of the steering.

In that trial of the 41 patients who achieved a complete response. The median duration of response was approximately two years by Kaplan Meier estimate among the 17 patients who entered the five year extension study. The median duration of response was three five years. These data contribute to the growing and consistent body of evidence demonstrating that this is Jerry.

The sustained response, observed offers real value to both patients and practices allowing management of recurrence with greater confidence and extending the time between recurrences importantly, the median duration of response has not been reached and the event rate has not accelerated and remains steady over time.

<unk> is not only effective in achieving a complete response, but also offers durable disease control over time, we're very optimistic about the emerging long term durability profile of the story.

According to the published literature the median, duration of response for TBT in this population is approximately 6 to 9 months with a substantial proportion of patients recurring within the first year.

I will now briefly update you on our clinical pipeline.

<unk> 301 is our investigational anti <unk> four antibody delivered via RT gel.

He is currently being evaluated in a phase one trial, both as monotherapy and in combination with <unk> 201, <unk> seven agonist and with Gemcitabine.

These results are further supported by the 5-year, follow-up data from Phase, 2 Optima, 2 study, in both newly diagnosed and recurrent disease which was published in the journal of clinical genital urinary cancer. This passage in

We share the latest data at the <unk> meeting in April and the safety profile continues to be favorable across both the monotherapy and combination arms, we observed clinical responses in both monotherapy and combination arms with follow up on the combination arms ongoing to evaluate the durability of response, we expect.

And that trial of the 41 patients who achieved a complete response, the median duration of response was approximately 2 years by Kaplan Meier estimate, among the 17 patients, who entered the 5-year, extension study the median. Duration of response was 3.5 years. These data contribute to the growing and consistent body of evidence demonstrating, that Zuri, is not only effective in achieving a complete response but also offers durable Disease Control.

To share updated data later this year and we'll use those results to guide a potential decision to move into phase III development.

Over time, we are very optimistic about the emerging long-term durability profile of Zuri.

I'll now briefly update you on the clinical pipeline.

As Liz mentioned earlier, we're also advancing our next generation formulations as history and Joe might own it.

Phase III Utopia trials evaluating <unk> in one of three the successors is jewelry in patients with recurrent low grade intermediate risk disease and has completed enrollment in this study is modeled closely on envision efficacy will be measured by the complete response rate at three months with follow up focused on assessing durability we.

Egn 301 is our investigational anti-ctla for antibody delivered via RT gel. It is currently being evaluated in a Phase 1, trial both as monotherapy. And in combination with ugn 2011, our tlr7 Agonist and with gemcitabine,

we share the latest data at the AUA meeting in April and the safety profile continues to be favorable, across both the monotherapy and combination arms.

Topline complete response data by the end of this year and we plan to share those results with the FDA to help inform the regulatory path forward we.

We are also taking a similar approach with your June 100 for our next generation formulation of <unk>.

We recently initiated a single arm phase III trial and patient screening is underway.

We observed clinical responses in both mono therapy and combination arms with follow-up on the combination arms, ongoing to evaluate the durability of response. We expect to share updated data later this year and we'll use those results to guide a potential decision to move into phase 2 development.

And final one our recently acquired next generation analytics virus candidate is progressing through IND, enabling studies with a phase one trial anticipated to begin next year.

As Liz mentioned earlier, we're also advancing our next Generation formulations as auri and gel minino.

I will now turn the call over to David for the commercial update.

Thank you Mark.

As my colleagues have shared we believes the story represents a true shift in how recurrent low grade intermediate risk non muscle invasive bladder cancer is treated.

The phase 3 Utopia trial is evaluating ugn. 103 the successor, this is Dury in patients, with recurrent low-grade, intermediate risk disease and has completed enrollment this study is modeled closely on Envision. Efficacy will be measured by the complete response rate of 3 months, with follow-up, focused on assessing durability.

Our focus now is on ensuring that all appropriate patients have access to <unk> and an accelerated and successful launch.

We expect Topline complete response data by the end of this year and we plan to share those results with the FDA to help inform the regulatory path forward.

We have completed the expansion of our Salesforce heavy increase the total number of reps from 50 to 82.

We are also taking a similar approach with ugn 104 our next Generation formulation of General Mito.

We recently initiated a single arm phase 3 trial in patients screenings on your way.

With this footprint, we believe we are well positioned to reach the 8500 health care providers, who treat approximately 90% of the addressable patient population.

We view the launch in two distinct phases.

UGM 501 or recently acquired next Generation on koltuk virus candidate is progressing through IND enabling studies with a Phase 1 trial anticipated to begin next year.

First phase covers the period from July through the end of this year.

The second begins on January one 2026, but we expect to receive a permanent product specific J code.

Thank you, Mark.

That milestone will be an important catalyst for broadening adoption, particularly in the community setting where reimbursement logistics play a critical role in treatment decisions.

It's my colleagues have shared. We believe the story represents a true shift in how recurrent low-grade intermediate risk. Non-muscle invasive, bladder cancer is treated

Our Focus now is on ensuring that all appropriate patients, have access to the story in an accelerated and successful launch.

During the initial phase of our commercial priorities fall into three areas.

Engaging with health care providers active.

We have completed the expansion of our sales force. Have you increase the total number of reps from 50 to 82?

Activating treatment sites and advancing market access.

First our field team is focused on building awareness, establishing clinical conviction and ensuring providers and staff are educated on how is the story will benefit appropriate patients.

With this footprint we believe we are well positioned to reach the 8,500. Healthcare providers, who treat approximately 90% of the addressable patient population

We view the launch in 2 distinct phases.

Even at this early stage, we are encouraged by the level of interest we're seeing.

The first phase covers the period from July through the end of this year.

Awareness around the story is strong and health care providers are eager to learn about the profile of the story and engage on appropriate patient types.

The second begins on January 1st 2026 when we expect to receive a permanent product specific J code.

Customer questions focus on the clinical operational and financial considerations to begin treating with history.

That Milestone will be an important Catalyst for broadening adoption, particularly in the community setting, where reimbursement Logistics, play a critical role in treatment decisions.

We are initially focused on a group of roughly 2000 physicians out of our total 8500 target universe.

During the initial phase, our commercial priorities fall into three areas.

Engaging with healthcare providers.

We've identified is likely early adopters. These are physicians, who have demonstrated a willingness to introduce new therapies during a miscellaneous J code period.

Activating treatment sites and advancing Market access.

First, our field team is focused on building awareness.

Our goal is to engage with the majority of accounts within the first six to eight weeks of launch and we are making strong progress towards that target.

Establishing clinical convictions and ensuring providers and staff are educated on how the story, will benefit appropriate patients.

Our discussions with physicians are focused on identifying patients who stand to benefit most from treatment with the story.

even at this early stage, we are encouraged by the level of Interest we're seeing

This typically involves those with multiple prior recurrences and a history of repeated <unk>.

Awareness around the story is strong, and healthcare providers are eager to learn about the profile of this story and engage on appropriate patient types.

Patients experiencing early recurrences after surgery and patients who may be poor surgical candidates due to comorbidities or other risk factors.

Customer questions, focus on the clinical operational, and financial considerations to begin treating with this story.

The second area of focus is site activation we.

We are initially focused on a group of roughly 2,000. Physicians out of our total 8,500 Target Universe.

We are working closely with practices and hospitals to ensure operational readiness.

This includes everything from distributor Onboarding, two clinical training and pharmacy processes.

Whom we've identified as likely early adopters are physicians who have demonstrated a willingness to introduce new therapies during a miscellaneous J-Code period.

As we have noted previously many providers prefer to initiate the use of new therapies like the story in the hospital outpatient setting for hospital pharmacy budgets are often managed at separate cost centers.

Our goal is to engage with the majority of accounts within the first 6, to 8 weeks of launch and we are making strong progress toward that Target.

Our discussions with Physicians are focused on identifying patients, who stand to benefit most from treatment with the story.

We are supporting this process, including working with PNC committees to ensure formulary placement as quickly as possible.

This typically involves those with multiple prior recurrences and a history of repeated tubes.

On the market access front, our team is actively engaged with major payers nationwide.

At this stage, we have secured open access for approximately 84% of covered lives.

Patients experiencing early, recurrences after surgery and patients who may be poor surgical candidates due to comorbidities or other risk factors?

The second area of focus is site activation.

These efforts are central to the launch and reflect our commitment to ensuring patients can access the history without unnecessary administrative or financial barriers.

We are working closely with practices and hospitals to ensure operational readiness.

Looking ahead to 2026, the assignment of a permanent J code should significantly simplify the reimbursement process at that point, we intend to broaden our commercial focus to include a broader segment of the urology market, including many more community based practices.

This includes everything from distributor onboarding to clinical training and Pharmacy processes.

As we have noted, previously, many providers prefer to initiate the use of new therapies like zeri in the hospital outpatient. Setting for Hospital. Pharmacy, budgets are often managed at separate cost centers.

Turning to Joe My though we continue to drive strong year over year unit growth, which reflects growing comfort and conviction among urologists.

We are supporting this process including working with pnt committees to ensure formulary placement as quickly as possible.

We see steady growth in both the number of sites of care and the number of new prescribers and we are encouraged by the positive trends in patient identification.

On the market access front. Our team is actively engaged with major payers Nationwide.

At this stage, we have secured open access for approximately 84% of covered lives.

The message around durability of response remains central and continues to resonate and our team is maintaining high frequency engagement with top performing accounts to sustained momentum and drive further growth.

These efforts are Central to the launch and reflect our commitment to ensuring patients can access the story without unnecessary, administrative or financial barriers.

I will now turn the call over to Chris Degner for a financial update.

Looking ahead to 2026. The assignment of a permanent J. Code should significantly simplify the reimbursement process.

Thank you David as Liz mentioned earlier, Joe might have net product revenues were $24 $2 million for the three months ended June 32025, compared with $21 8 million in the same period in 2024 year over year revenue growth of 11% was driven by underlying demand growth of 7% and price favorability as the gross to net.

At that point, we intend to broaden. Our commercial Focus to include a broader segment of the Urology Market including many more Community Based practices.

Turning to John Mido, we continue to drive strong year-over-year unit growth which reflects growing comfort and conviction among urologists.

<unk> has stabilized in recent quarters R&D.

R&D expenses for the second quarter of 2025, or $18 9 million, including noncash share based compensation expense of <unk> 4 million. This compares to $15 4 million, including noncash share based compensation expense of <unk> 6 million for the same period in 2024.

We see steady growth in both the number of sites of care and the number of new prescribers, and we are encouraged by the positive Trends in patient identification.

The message around durability of response remains Central and continues to resonate and our team is maintaining high frequency engagement with top, performing accounts to sustain momentum and drive further growth.

The increase in R&D expenses of $3 $5 million was primarily driven by higher manufacturing costs for <unk> story and costs associated with the phase III Utopia trial view June 103, partially offset by lower clinical trial costs and regulatory expenses in connection with the story.

I will now turn the call over to Chris Denman for a financial update.

<unk> general and administrative expenses for the second quarter of 2025 were $43 $2 million, including noncash share based compensation expense of $2 $3 million.

7% and price capability as the gross to net rate for Meto, has stabilized in recent quarters,

This compares to $30 1 million, including noncash share based compensation expense of $3 million for the same period in 2020 for the.

Year over year increase of $13 1 million was primarily driven by the story commercial preparation activities as well as an increase in overall commercial cost.

R&D expenses for the second quarter of 2025 or 18.9 million including non-cash, share-based compensation, expense of 0.4 million. This compares to 15.4 million, including non-cash, share-based compensation, expense of 0.6 million for the same period in 2024.

We reported non cash financing expense related to the prepaid forward obligation to RTW investments of $4 6 million in the second quarter of 2025 compared to $5 8 million in the same period in 2024.

The increase in R&D expenses of $3.5 million was primarily driven by higher manufacturing costs for the USA story and costs associated with the Phase 3 Utopia trial for Yugi and 103, partially offset by lower clinical trial costs and regulatory expenses in connection with the story.

Interest expense related to the term loan facility with funds managed by Pharmacon advisors was $4 $1 million from the second quarter of 2025.

Compared to $3 5 million in the same period in 2020 for the.

Selling General and administrative expenses for the second quarter of 2025 were 43.2 million including non-cash. Share-based compensation expense of 2.3 million

The increase was primarily driven by interest expense related to a third tranche of the loan that was funded in September 2024.

This compares to the $30.1 million, including non-cash, share-based compensation expense of $3 million for the same period in 2024.

We do not intend to draw down the fourth and final tranche of $75 million that is available to us at our discretion until August 29 2025.

The year-over-year increase of 13.1 million was primarily driven by the story commercial, preparation activities, as well as an increase in overall commercial costs.

Net loss was $49 $9 million or $1 <unk> per basic and diluted share in the second quarter of 2025, compared with a net loss of $33 4 million or <unk> <unk> per basic and diluted share in the same period in 2024.

We reported non-cash financing expense related to the prepaid Ford obligation to rtw, Investments of 4.6 million in the second quarter of 2025 compared to 5.8 million in the same period in 2024.

As of June 32025, cash cash equivalents in marketable securities totaled $161 6 million.

Interest expense related to the term 1 facility with funds managed by Farm account, advisors was 4.1 million in the second quarter of 20125.

Turning now to guidance, our full year guidance for <unk> remains unchanged. We continue to expect full year 2025, net product revenues from <unk> to be in the range of $94 million to $98 million.

Compared to 3.5 million in the same period in 2024. The increase was primarily driven by interest expense related to the third strong to the loan. That was funded in September 2024.

And this implies year over year growth of approximately 8% to 12%.

We do not intend to draw down the fourth and final tranche of 75 million that is available to us at our discretion until August 29th 2025.

The $87 $4 million in demand has driven <unk> sales in 2024.

This excludes the $3 million increase ex sales reported in the 2024.

Guidance on full year 2025 operating expenses is also unchanged and is expected to be in the range of $215 million to $225 million.

Net loss was 49.9 million or 1 dollar 5 cents per basic and diluted share in the second quarter of 2025 compared with the net loss of 33.4 million or 82 cents per basic and diluted share and the same period in 2024.

Including noncash share based compensation expense of $11 million to $14 million.

as of June 30th, 2025 Cash, Cash, equivalents and marketable, securities total 161.6 million

We anticipate operating expenses to decrease modestly over the remainder of the year, reflecting the impact of several nonrecurring costs incurred during the first half of 2025.

Partially offset by the sales force expansion in the second half of the year.

Turning now to guidance our full year, guidance for Joe Mido remains unchanged. We continue to expect full year 2025. Net product revenues from jaido to be in the range of 94 to 98 million.

These nonrecurring costs totaled approximately $15 million and included expenses related to the acquisition of <unk> 501.

And this implies year-over-year growth of approximately 8 to 12% over the 87.4 million in demand driven, Joe Mido sales in 2024,

Preparations for the <unk> or.

Our national launch meeting for the story the.

This excludes the million dollars and creates sales reported in 2024.

The manufacturing expenses for is a story, which were accounted for as R&D expense prior to FDA approval.

That concludes our prepared remarks, we're now ready to open the call for questions.

Guidance on full year 2025 operating expenses is also unchanged and is expected to be in the range of 215 to 225 million.

Later.

Including non-cash, share-based compensation expense of 11 to 14 million dollars.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile the Q&A roster.

We anticipate operating expenses to decrease modestly over the remainder of the Year, reflecting the impact of several non-recurring costs incurred, during the first half of 2025,

Partially offset by the sales force expansion and the second half of the year.

Our first question comes from Tara Bancroft with TD Cohen, Karen go ahead with your question.

These non-recurring costs total of approximately 15 million dollars and included expenses related to the acquisition of UGM 501.

Preparations for the zest story odac.

Thanks, and good morning, Thanks for taking the questions. So I have to ask the obligatory first question on all of our mines is there anything that you can offer on metrics you've hit so far for July like I mean script rate number of active accounts are prescribers that you have a really anything qualitative like the perceived level of.

Our national launch meeting for the story.

The manufacturing expenses for our story, which were accounted for as R&D, expense prior to FDA approval.

That concludes our prepared remarks. We are now ready to open the call for questions, operator.

Pent up demand from those who are maybe waiting to get a <unk> to instead receive that story, if any things like that thank you.

Yes, great question, Terra Hi, <unk> I'm going to ask.

David comment and then I'll add some color as well so David.

Thank you. At this time. We will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced to withdraw your question. Please, press star 1 1, again please, stand by while we compile the Q&A roster.

Yes. Thanks for the question, we're really excited by the positive receptivity of not only the health care providers that we have engaged but also the payer community.

Our first question comes from Terra bankrupt. With TD Cohen Tara go ahead with your question.

As we heard prior to launch they are very eager for a new treatment option and.

They took on his history product profile with great enthusiasm. So we are very pleased with how we've heard about it.

In this stage of the launch as we said, we're really actively engaging physicians we're helping.

Helping them identify sites of care and importantly, we're also continuing to make sure that market access.

If any, um, things like that. Thank you.

We lay the groundwork for market access so that all the patients have access to the product per label. So.

Anyway. Thank you for the question and will.

Great question, Tara, Heights, Liz. And I'm going to ask um, David to come in and then I'll probably add some color as well. So David

Looking forward to sharing more results in the future, yes Tara.

Give me a little bit more color on that one we're not going to give metrics at this point.

Im sure everybody would love to have downside, it's still very early for us what I will tell you is that we've all been spending a lot of time out in the field and talking to doctors and to David's point is a lot of excitement and what you hear from doctors is.

They all have patients and I wanted to sort of.

Put a note on patients.

Because when you launched <unk>, it's like I have a patient and when we talk to doctors today. They have several patients. The biggest hurdle frankly is reimbursement, which we knew that I can tell you that I went to any of that last week with a lot of practice.

Yeah, thanks for the question. Um, we're really excited by the positive receptivity of. Not only the healthcare providers that we have engaged but also the payer Community uh as as we heard prior to launch uh they're very eager for a new treatment option and uh they took on these Theory product profile with great enthusiasm. So we are very pleased with uh, how we've heard about it um, in the stage of uh, the launch. As we said, we're really actively engaging Physicians. We're uh, helping them identify sites of care, and importantly, we're also continuing to make sure that market access. Um, we lay the groundwork for Market access so that um all the patients have access to the product per label. So um anyway, thank you for the question and uh we'll

Practices and doctors and the first thing they say so maybe you get a permanent J code as soon as you get a permanent J code in Ah.

Be looking forward to sharing more results in the future. Yeah, I Tara look um

Be a little bit more color on that 1. We're not going to give

you a metrics and

Patients waiting.

And we've always said that would not be a bolus of patients, but again, what I can tell you is that our paths are coming and patient enrollment forms. So the top of the funnel, we're very happy with where we're going there and the team as David said is working.

Then, um, you know, I'm sure everybody would love to have them but it's still very early for us. What I will tell you is that we've all been spending a lot of time out in the field and talking to doctors and to David's Point. There's a lot of excitement and what you hear from doctors is they all have patience. And I want to sort of, um,

The sites of care pulling those through.

Yes, dosing really getting patients dose.

I would say at this client.

Put a note on patience because you know, when you launched John Mido, it's like I have a patient. And when we talked to doctors today, they have several patients

Very optimistic we feel really good about where we are we think.

Consensus as we said for the for the year.

We are still aligned with that and.

I now have the opportunity to see some real uptake over.

Over the next few months I do think David commented. This in the prepared remarks that you will see.

That the biggest hurdle frankly is a reimbursement which we knew that. Um I can tell you that I went to an event last week with a lot of um Community practices and doctors and the first thing they say as soon as you get a permanent J Code as soon as you get a permanent J Code, I've got it but you know, patients waiting.

We don't, and we've always said that would not be bullish.

Acceleration after the first of the year when we had the J curve, but we have the hospitals, we have institutions and we've got some large practices that are all willing to right. So it sounds like no one is willing to take.

Uhm miscellaneous code, but you do see a big difference.

And sort of attitude kind of before and after but the good news is is that all of the metrics that backward getting have not talked to one doctor who said no I don't see a role for this and none of them frankly that say, they're going to really limited.

A patient. Um, but again, what I can tell you is that our tests are coming in patient enrollment form. So the top of the funnel, we're very happy with where we're going there. And the team, as David said, is working, um, you know, the sites of care pulling those through, um, you know, and dosing, you know, really getting patients dosed. Um, so I would say at this point, we're very optimistic. We feel really good about where we are. We think the, um, consensus, as we said for the year, uh, we are still aligned with that and, um,

And again, a lot of excitement around using this in multiple patients and they're in their practice, so hopefully that extra color helps without giving very specific.

Numbers for you, but David also mentioned sites of care, we have set up a lot of sites of care and we're on track with where.

And the number of sites of care that we already have set up.

So far that to deliver on what we have.

Great.

David we are going to deliver for the year, so hopefully that helps.

Yes, definitely that's all very helpful. Thank you so much.

Standby for our next question.

Our next question comes from Michael Schmidt with Guggenheim. Michael Go ahead with your question.

Hey, guys. Good morning, Thanks for taking my questions of perhaps a follow up just on the early launch here. We certainly had some very positive feedback from urologists does a lot of that we spoke with in terms of intent to prescribe.

Therapy, but I'm just curious what are you seeing so far around the reimbursement process early on and are using a miscellaneous code just curious if you could.

Comment, perhaps how much.

So it's not like no 1's willing to take to, uh, you know, do it during the miscellaneous code. But you do see a big difference in, um, in sort of attitude, kind of before and after. But the good news is, is that all of the, um, the metrics, the feedback we're getting have not talked to 1. Doctor Who said, no, I don't see a role for this, and none of them, frankly. They say they're going to really limited. Um, you know, again, a lot of excitement around using this in, you know, multiple patients in their, in their practice. So hopefully that extra color helps, uh, without giving very specific, um, you know, numbers for you. But David also mentioned sites of care. We we have set up a lot of sites of care and we're on track with where we need to be. And the number of sites that care that we already have set up, um, you know, this uh, so far that uh, to deliver what we've um, you know, what we've uh, stated we would deliver for the year so hopefully that helps

Time, it takes in terms of intent to prescribe until the conversion to <unk>.

Yeah, definitely. That's all very helpful. Thank you so much.

<unk> prescription.

Again, bye. For our next question.

Anything along those lines would be helpful. And then I had a follow up.

Sorry go ahead David.

Thank you for the question Michael.

Our next question comes from Michael Schmidt. With Guggenheim, Michael, go ahead with your question.

I'll just comment on the initial process in terms of educating accounts. So as we discussed in our prepared remarks, we are really focused on a group of around 2000 providers that have demonstrated a willingness to adopt product. During this particular period and so that's pretty much what we're seeing in terms of interest rate there.

One of the things, we do which.

Is very similar to what we did with Joe <unk> at that launch is we spend a good amount of time educating them on the actual process for claims and billing and then reimbursement. So we educate them fully on on that so it's white glove service and with that they have the reassurance of knowing that they're in.

They enroll a patient they know what their patients co pay is going to be what the coverage is going to be in the office feels.

More reaffirmed in terms of how that process is going to work as you know with the miscellaneous J code period. It is a little bit of a different process, because it's manual, but what we're seeing so far is that when we engage the practices they feel assured that.

What theyre doing is setting them up for a positive experience, but too early to get too early that we haven't had any quite unquote paid.

Claims yet so it's too early to start to say how long is it going to take.

As we start to see that coming through we will be able to give you more color on that but it's too early to see that.

Alright, and then I guess, if you were to compare the in this whole experience.

The storylines tier experienced with <unk> five years ago.

I guess, how much commercial synergies are there in place today, given your commercial footprint around the <unk> product.

Yep, sir, go ahead, David. Yes, thank you for the question, Michael. Um, I'll just comment on the initial process in terms of educating accounts. So as we discussed in our prepared remarks, we are really focused on a group of around 2,000 providers, that have demonstrated, willingness to adopt product during this particular period. And so, that's pretty much what we're seeing in terms of Interest right there. 1 of the things we do, which um, is very similar to what we did with Joe Mido at that launch, is we spend a good amount of time? Educating them on the actual process for claims and billing and then reimbursement, so we educate them fully on, um, on that. So it's white glove service and with that, they have the reassurance of knowing that they've in the, in, when they enroll a patient, they know what that patient's co-pay is going to be, they know what the coverage is going to be, and the office feels uh, more reaffirmed in terms of um how that process is going to work as you know, with the miscellaneous.

Any key learnings that.

The launch of jewelry essentially into a very similar from a market here.

J Code period. Um it is a little bit of a different process because it's manual but what we're seeing so far is that when we engage the practices um they feel assured that um what they're doing is setting them up for a positive experience.

Yes, since March and I haven't seen only two people here when we launched.

But too early to get too early to say we haven't had any quote unquote paid. Um,

I'll give you some comment and ask mark to add anything.

I think the.

Similar in a lot of ways in the sense of what you have to do with the J code, which has to do with reimbursement Wojciech <unk> identifying patients so and what you have to deal with frankly for office to get set up set up with the distributor. The good news is obviously a lot of these offices are.

Claims yet. So it's too early to sort of say, how long is it going to take, um, you know, as we start to see that coming through, we'll be able to give you more color on that. But it it's it's too early to see that.

Ready setup. So all we have to do is to add.

Add in this journey, where they already were so so there is a little bit of paperwork that happens there absolutely with some of the first.

Right. And then I guess if you were to compare the initial experience of the, the story lines to your experience with gel Mido 5 years ago. Um, you know, I guess how much commercial strategies are there in place today, you know, given your commercial footprint around the gel Mido product. Um, and you know, any key learnings that, um, as as you launch this story essentially into a very similar similar Market here.

Physicians that we see that are writing far as history, our riders of job, so which makes a lot of sense.

And I think what we also are seeing that.

Yeah, since, uh, Mark, and I was the only 2 people here when we launched, um, Domo, I'll give you some comment and asked Mark to add anything. You know, I, I think the

For the most part people were really happy with the.

Support that we gave them, which are <unk> and are happy with the support that they're getting again physicians that I've personally interacted with have commented about particularly our reimbursement team because thats. The number one thing right now and how good is how good they are knowledgeable. They are helpful. They are.

If if similar in a lot of ways in the sense of, you know what, what you have to deal with, with the J Code, what you have to do is with reimbursement, which you have to deal with identifying patients. So and what you have to deal with frankly for uh, office to get set up, you know where it's set up with the distributor. The good news is obviously a lot of these offices are already set up. So all we have to do is add

And then I am going to let Mark talk about the numbers because I think that's a big big difference between watching while we heard when we launched our might have versus what we're hearing now that mark yes. Thanks Laurence.

So it's I think obvious to many on the call that we're dealing with a completely different demographics so to speak.

Demographic opportunity.

Upper tract <unk> carcinoma, the target or <unk> is a very small population of patients.

On average most practicing urologist will see one or two patients a year. So it's hard to find the patients and it's hard to find.

Individuals' true Jo Mira, which I think explains a lot of experience with one of the gel minor ramp has been what it has been but that's very different than what we're dealing with with the <unk> launch there are lots of patients who qualify bye.

By the label alone.

For the use of this drug and physicians are exceedingly.

Familiar with this population of patients. These are people who are sitting in the office on a very regular basis.

You know, add in says, Dury where they already were. So, so there is a little bit of paperwork. You know, that happens there. Absolutely. Some of the First physicians that we see that are writing far as this Dury are writers of John Mayo. So which makes a lot of sense. Um, and I think the, you know, what we also are seeing is that, you know, for the most part people were really happy with the, the, uh, support that we gave them with John Mido and or happy with the support that they're getting again. The Physicians that I've personally interacted with have commented about particularly our reimbursement team because that's the number 1, you know, thing right now and and how how good is, how good they are, how knowledgeable they are, how helpful they are. And then I'm going to let Mark talked about the numbers because I think that's a big big difference between what you what we heard when we launched Joe Mido versus what we're hearing now. So Mark. Yeah. Thanks Liz. Um, so it's, I think,

So I do think although as was pointed out in many of the sort of mechanical issues related to bringing the drug into the practice are similar and we will be familiar to people who have used yamato the opportunity of ease of administration and the fact that it is going to be given in an office with essentially minimal physician involved with this because it's driven by a nurse will really change.

<unk> the way of his history experience looks compared to our experience previously with Joe might have lunch.

Um obvious to many on the call that we're dealing with a completely different demographic, so to speak. Um and demographic opportunity uh upper track your ethereal carcinoma and the target of gel Mito. Use is a very small population of patients and you know on average most practicing urologists will see 1 or 2 patients a year. So it's hard to find the patients and it's hard to find um, you know, individuals to treat with Joe Mido, which I think explains a lot of the experience with why the gel material ramp has been what it

And I'll just squeeze one more and this one is on.

<unk> Gen. One out of three and so now with the Utopia study fully enrolled.

I was just curious.

My husband. That's very different than what we're dealing with with, uh, this is a story launch. There are lots of patients who qualify, uh, by the label Alone, um, for the use of this drug and Physicians are exceedingly. Um,

If you had the chance to have any additional discussions with the regulators in terms of sort of coming off of the panel earlier. This year in terms of whether the study is in fact supportive of potential approval and.

From a from a clinical perspective is the goal to essentially a rep produce the envision data or is there opportunity to differentiate clinically with one of the three thanks so much.

Yes, no great question.

I have not interacted its we don't have enough data yet we're waiting on additional data before we interact with the FDA, but we will absolutely do that and have feedback for you prior to the end of this year. So I think that's the timing on that the goal is to replicate and we actually have.

Familiar with the with this population of patients, these are people who are seeing in the office on a very regular basis. So, you know, I do think, although, as Liz pointed out, many of them, sort of mechanical issues related to bringing the drug into the practice, or similar, and will be familiar to people who have used young Mido, the opportunity, the ease of administration. The fact that this can be given in an office with essentially minimal physician involvement. This can be driven by a nurse uh, will really change the way of the Zuri experience. Looks compared to our experience previously, with Joe M lunch.

Purposely did that because what we didn't want to do is introduce and a potential issues right that would that would muddy the waters as far as as far as the data is concerned that we tried to replicate almost exactly the envision study. So there unfortunately differentiation, but fortunately what we're doing is trying not to enter.

To introduce any biases, our expectation is that the FDA will.

Accept that study as they had previously communicated mainly because this is a new formulation and they actually have <unk> history as a historical control now so.

We do plan to interact again with them, we'll have feedback for you before the end of the year, but that's our expectation and Thats why were moving forward with having said that we and ourselves we want to continue to expand the use of the AGM. One of three so we are in the planning additional lifecycle management studies.

Let's try to squeeze 1 more in, in this 1's on, uh, on Eugie and 103. And so, now with the uh Utopia study fully enrolled, um, I was just curious. Um, if you had the chance to have any additional discussions, uh, with with, with The Regulators in terms of, you know, sort of coming off of the, uh, the panel earlier this year, in terms of, whether the, the study is, in fact, supportive of potential approval and, um, from a, from a clinical perspective, you know, is the goal to essentially reproduce The Envision, uh, data or is their opportunity to differentiate clinically with uh, 1 or 3? Uh, thanks so much. Yeah, no great question. Um, we have not interacted. It's uh, we don't have enough data yet. So we're waiting on additional Data before we interact with the FDA but we will absolutely do that and have uh feedback for you prior to the end of this year. So I think that's the the the timing on that the goal is to replicate and that we

That we will start fairly quickly on <unk> three <unk>.

Regardless of the FDA feedback, but we have other studies that would want to do in other populations and well be starting those as quickly as possible.

Thank you.

we we actually purposely did that because what we didn't want to do is introduce any potential issues, right? That would that would muddy the waters as far as um as far as the data is concerned. So we tried to replicate almost exactly The Envision study so there unfortunately, there's no differentiation but fortunately what we're doing is trying not to do introduce any biases. Um, our expectation is that the FDA will um, except the study as they had previously communicated

Our next question comes from Leland <unk> shell.

With Oppenheimer Leland go ahead with your question.

Hi, good morning, and thanks for taking our questions if you're from.

Yes.

With respect to the first phase of the launch pre the J code assignment wondering as Youre going after those 2000 docs you've identified something doctors.

Can you just share what others breakdown with respect to community versus academic docs can you think of the academic those who participate in academic setting is maybe having easier access to the medication is a miscellaneous J code easier in the hospital setting or through that.

Indicated. Mainly because this is a new formulation and they actually have UGM 102 this Dury as a historical control now. Um, so uh, we do plan to interact again with them. We'll have to be back for you before the end of the year. But that's our expectation. And that's what we're moving forward with having said that we and ourselves want to continue to expand the use of UGM 103. So we are in the planning of additional life, cycle management studies that we will start fairly quickly on UGM 103, um, you know, regardless of the FDA, uh, feedback. But we have other studies that we want to do in other populations. And we'll, we'll be starting those, um, as quickly as possible.

Thank you.

Process is there a TNT committee.

That mix that we should consider.

Our next question comes from Leland Gershel.

This is Jerry in the hospital setting if you could share any color around that as we think about 2025 sales for the J code takes them. Thank you.

With, Oppenheimer Leland. Go ahead with your question.

Yeah, absolutely David Thanks, Leland the majority of that 2000 physician I'll say early adopter list that we've identified reside in the community and there are some institutional settings and as you know some have privileges and hospitals as well. So when we think about them gaining access to the story it is.

There is a spectrum and private practice as we've mentioned there is.

Historically, some hesitation there and so what we've tried to do is help them identify a site of care, where they can administer the story for the first time and gain experience and that often is in a hospital outpatient setting.

Hi. Good morning and thanks for taking our questions a few from from us. Um you know with respect to this first phase of the launch, you know pre the um the J Code assignment wondering, you know as as you're going after those 2,000 docs, you've identified, you know, it's probably a doctor's. Um, can you share what how this breakdown with respect to community versus academic docs? Should we think of the academic? Those who practice in the academic setting is maybe having, you know, easier access to the medication is the, you know, miscellaneous, J Code, you know, easier and

If it is a specific hospital account.

I think that process varies but generally speaking you will see that they have formal PMT reviews, and so one of the things. We did immediately upon launch was engaged major accounts. So that we can begin working with them to provide the clinical the operational and financial information to support a successful PMT review.

Hospital setting or through that, um, process. Um, is there a TNT committee Dynamic that we should consider for as this jury, uh, in the hospital setting? If you could share, you know, any color around that as we think about, you know, 2025 sales for the the jco kicks in. Thank you.

Yep. Absolutely.

Okay great.

And then just another question with respect to.

Yeah, thanks Lynn. Uh, the majority of that 2,000 position, um, I'll say early adopter list that we've identified reside in the community, and there are some in institutional settings. As you know, some have privileges in hospitals as well. So, when we think about um, them gaining access to the story, it is, um, there's a spectrum in private practice, um, as we've mentioned.

The Utopia.

Trial.

Yesterday.

Ask for.

Longer durability data or anything that maybe incremental to what was shown with envision or do you think it truly would be kind of a replicate of envision data set that could get one or two points. Thank you.

Historically some hesitation there. And so what we try to do is help them identify a site of care where they can administer the story for the first time and gain experience. And that often is in a hospital outpatient setting.

Thanks, Leland, Yes, we are.

We're expecting it to be similar to.

What we presented for envision.

We're going to talk to the FDA about their expectations, but our expectation is that it would be it would mirror similar.

Types of requirements as envisioned mainly concentrating on CR with some reasonable amount of durability data and that would obviously be something that we'd have to talk to you can see that.

If it is a specific Hospital account. Um, I think that process varies. But generally speaking, you'll see that they have, uh, formal pnt, reviews, and so 1 of the things we did immediately upon launch was engage the major accounts so that we could begin working with them to provide the clinical, the operational, and financial information to support a successful pnt review.

Okay. Thank you.

Okay, great. Um, and then just another question with respect to

Our next question comes from Jeremy <unk> with HC Wainwright and company go ahead with your question.

the, uh, Utopia, uh, trial. Um, do you think the FDA would ask for?

Thanks, very much for taking my questions and congratulations on all the progress so far I wanted to ask first of all about clarification of a couple of commercial things firstly.

A longer durability data or anything that may be incremental to what was shown with envisioned, or do you think it truly would be, um, kind of a replicative of The Envision data set that I could get 1 at 3 app? Thank you.

You alluded to once the formal J code assignation is complete at the beginning of next year that there would be outreach facilitated by that to a broader group of prescribers can you maybe quantify for us how many more prescribers are likely to be targets beyond the initial 2000.

And then also I wanted to ask if you are seeing any evidence that the commercial availability of the story and the increased visibility of the company overall is having any potential beneficial spillover effect on jump micro itself and if youre seeing any noteworthy reacceleration of momentum in <unk>.

Envision uh we um we're we're going to talk to the FDA about their expectations but our expectation is that it would be it would it would mirror a similar um, types of requirements as indigenous, namely concentrating on Crescent with some reasonable amount of durability data and that would obviously be something that we'd have to talk to the agency about

Okay, thank you.

Our next question comes from, rajaram vahu with HC rain, Wright, and Company. Go ahead with your question.

It causes the story is now available.

Yes, Thanks, Rob David.

Hey, Rob Thanks for the question. So on your question around how we're going to engage the total universe. So as we said we are focused on the 2000 that we think are very important. So the early stages of a launch it doesn't mean that we won't see others in the universe. If theyre in the same office, but broadly speaking as we turned the corner into 2026, we will.

We'll expand our efforts beyond that 2000 and that will begin very rapidly then expanding our reach to a greater number of them. So I would say by the middle of next year, we're going to see we're going to be broadly engaging everyone in that total universe and keep in mind that universe also includes in each office.

Physician assistance Theres nurses, so our efforts go well beyond just the HCP with regard to your question on <unk>, it's too early to say that but what I can tell you. What we've observed so far is that as Liz mentioned those who've used Joe Mito definitely understand the technology behind the story.

Thanks so much for taking our questions and congratulations on all the progress so far. I wanted to ask first of all about, uh, clarification of a couple of commercial things. Firstly, uh, you know, you alluded to once the uh formal J Code. A nation is complete at the beginning of next year. That there would be Outreach facilitated by this to a broader, uh, group of prescribers. Can you maybe? Quantify for us, how many more prescribers are likely to be targetable beyond the initial 2000? And then also, I wanted to ask if you are seeing any evidence that the commercial availability of the story and the increased visibility of the company overall is having any potential beneficial spillover effects on Joe Mito itself. And if you're seeing any noteworthy react of momentum in jahleed, that causes the story is now available.

Yeah. Thanks Ron. David

And what I would say as we move forward in time as we penetrate the overall market for low grade intermediate risk non muscle invasive bladder cancer in history, we will see.

That increased reach and frequency through the universe will support the continued steady growth of <unk>.

Great and then just one follow up with respect to you Jan 103, I was wondering if at this juncture you have any reason to believe that because of the characteristics of the new formulation 103 might have advantages and safety tolerability or ease of administration relative.

Because the story itself.

Ron. Thank you. The answer is we don't we didn't expect any real changes.

Hey Rob, thanks for the question. So on your question around um, how we're going to engage the total universe. So as we said, we're we are focused on the 2000 that we think are very important to the early stages of a launch. It doesn't mean that we won't see others in the universe if they're in the same office. But broadly, speaking as we turn the corner into 2026, we will expand our efforts. Um, beyond that 2000 and we'll begin very rapidly, then expanding our reach to a greater number of them. So I would say by the middle of next year, we're going to see, we're going to be broadly. Engaging everyone, in that total universe and keep in mind that Universe also includes in each office. There's a physician assistance. There's nurses. So, um, our efforts go well beyond just the hcp with regard to your question on, um, Joe Mido. It's too early to say that, but what I can tell you what we've observed so far is that as Liz, mentioned those who have used gel Mido, uh, definitely understand the technology behind the story.

For the audience just to remind you of the <unk>.

Principal issues related to this formulation relate to solubility ease of reconstitution.

Related to a change in the excipient preparation, but we don't expect to change in terms of the clinical profile and where it's premature for us to talk further about that and we will be happy to share those data when we havent later in the year.

And uh, what I would say, as we move forward in time, as we penetrate the overall market for low-grade, intermediate risk, non-muscle invasive, bladder, cancer, and Zuri, uh, we will see that that increased reach and frequency. Um, through the universe will support, the continued steady growth of gel Mido

Yes.

Thank you.

As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

Great. And then just 1 follow-up with respect to ugn 103. I was wondering if that this juncture you have any reason to believe that because of the characteristics of the new formulation 103 might have advantages in safety. Tolerability or ease of administration relative to the story itself.

Our next question comes from Paul Choi with Goldman Sachs. Paul Go ahead with your question.

Hi, Thank you good morning, and thanks for taking our questions.

I also wanted to follow up on Utopia, maybe ask is there anything.

In terms of either the data or product profile that you might call out that would allow you to address additional segments of the low grade intermediate risk population.

Feel like you can currently starting just sort of would there be any sort of incremental subset of patients that might be better candidates for that product.

Um, Ron, thank you. Uh, the answer is, we don't, uh, and we didn't expect any, uh, real changes. Uh, for, for the, um, audiences to remind you of the principal issues related, to this formulation relate to solubility. Use of reconstitution, um, related to a change in the exhibits of the preparation, uh, but we don't expect to change in terms of the clinical profile and and we're it's premature for us to talk further about that and we will be happy to share those data when we have them later in the year.

Thank you.

And my second question on sorry, I was just.

I guess as you think about sort of the product.

Let me drill flow and doctors' offices.

As a reminder, to ask a question, you will need to press star 1 1 1 on your telephone and wait for your name to be announced to withdraw your question. Please press star 1 1 1 again.

Can you maybe just comment on how youre thinking about non positions such as licensed nurse practitioners.

As a percentage of the.

Our next question comes from Paul Choi with Goldman Sachs Paul. Go ahead with your question.

Mix and are there other requirements for non neurologist too to use the use of the product thanks for taking our questions.

Go ahead, Mark you want to answer the Utopia question are there any yeah sure hi, Paul. Thank you for that so the answer to the first question is no as Liz mentioned, we are really formatting. The devaluation of 103 in the Utopia trial in exactly the same manner as we did <unk> envision so it would be.

Applicable to the same population of patients and we wouldn't expect.

Change in terms of the target population would be used initially of what you are anticipating I think in your question is the possibility of us doing additional clinical trials, which is something we have to talk about think about and Liz will ultimately make a decision about but currently the plan is for the same group of patients with that drug when it becomes available and is approved but what as I mentioned earlier we.

Hi. Thank you. Good morning, and thanks for taking our questions. Uh, I also want to follow up on Utopia, maybe ask, you know, is there anything in terms of either the data or or product profile that you might call out that would allow you to address, you know, additional segments of the uh low-grade intermediate risk population that you, you feel like you can't currently tap with this story and just sort of. Would there be any sort of incremental subset of patients? That might be better candidates for for that product. Um and my second question on Z zero is just um,

We expect to expand.

<unk> III into other patient population, but not because it's different vince's history right from a clinical perspective, but just because we would be doing that with UTI and one or two so it makes more sense for us to be doing that with new GM. One of three assuming the data is very similar as we start to as the data starts to play out, but that's our expectations.

We will expand absolutely into other patient populations, but not really driven by any differences, we see David you want to answer the question around the story.

So on the question of the story and actually who might be administering this in the office.

We're hearing early on is obviously the physician will want to be.

Understanding the entire process the ordering all the way through administration, but we do expect and we've heard this consistently that as practices get more experience that it will really fall on the shoulders of someone specifically, who does intra vesicle therapies likely a nurse.

And so that's pretty much what we're hearing right now consistent with what we learned before launch and we are engaging all people in the practice right everybody from physician to here.

Go ahead. Mark, you want to answer the Utopia question? Are there any? Yeah? Sure. Uh, hi Paul. Uh, thank you for that. Uh, so the answer to the first question is no. As Liz mentioned. We are really formatting the uh the evaluation of 1 of 3 in the Utopia trial in exactly the same manner as uh we did. So durian and vision. So it would be applicable to the same population of patients that we wouldn't expect uh a change in terms of the the target population would be used in initially. What you're anticipating. I think in your question is the possibility of us doing additional clinical trials, which is something we we have to talk about and think about and Liz will ultimately make a decision about but currently the plan is for the same group of patients, uh, with that drug when it becomes available and is approved. Yeah, but what, as, as I mentioned earlier, we absolutely expect to expand, um, UGM 103 into other patient populations, but not because it's different than just as as Dury, right? From a clinical perspective, but just because we would be doing that with Yugi and 102, so it makes more sense for us to be doing.

As to your yes.

The reimbursement team so from that perspective included in the 8500 target.

Our other targets outside of physicians will continue continue to do that this is a fall.

Comprehensive account Sal and needs to be but in the beginning clearly the position conviction around wanting to use it is going to drive the early adoption.

That with UGM 103 assuming the data is very similar as we start to as the data start to play out. But that's our expectation. So we will expand absolutely into other patient populations but not really driven by any differences. We see David. You want to answer the question around the story. Yeah so on the question of the story and actually who might be administering this in the office? Um what we're hearing early on is that obviously the physician will want to be um understanding the entire process. The you know, ordering

So thanks Paul.

Okay.

Our next question comes from Adrian <unk> with Ladenburg <unk> you can go ahead with your question.

Hi, Good morning, everyone. Thank you for taking my questions and congrats on the quarter.

Couple of questions. So first on <unk>.

Wanted to ask that.

If there were not questions about.

Permanent J code, if we didn't have any ships with Jacob please see a permanent J code. This year, how many patients do you think it would be possible.

To those in 2025, so the reason I'm asking because envision trial enrolled very quickly I think 420 patient 10 months gross 90 side. So I'm just trying to understand if we did not have reimbursement.

All the way through Administration. Um, but we do expect and we've heard this consistently that um, as practices get more experience that it will really fall on the, the shoulders of someone specifically who does intravesical therapies, likely a nurse. Um, and so that, that's pretty much what we're hearing right now. Consistent with what we learned before launch and we are engaging all people in the practice, right? Everybody from Physicians to your POs to your, um, you know, the, the reimbursement team. So from that perspective, you know, included in the 8500, Target, you know, are other targets outside of position, so we we'll we'll continue continue to do that. This is a full, you know, uh, comprehensive account. Sell it needs to be, but in the beginning, clearly the Physicians conviction around wanting to use it is going to drive the early adoption.

So, thanks Paul.

Reimbursement issues at this point, so how many patients would it be possible to dose 2025.

Yeah look that's a great question not one that we're going to speculate on.

Our next question comes from Aiden Husno with Leaden. Go ahead with your question.

But suffice it to say that absolutely. It's a significant number of patients as I mentioned earlier that number one the number one barrier right now is reimbursement and its not around that desire for clinical use and that's a good that's a good thing.

Hi, good morning everyone. Thank you for taking questions and congrats, uh, with the quarter. Um, good. Couple of questions, we'll now. So first, um, I wanted to ask that, um, if

That's a really good thing I mean rarely do you rollout where theres not question more questions around that clinical data that clinical use that patient identification and we're not hearing that the only the only again on all the conversations I've had its only been <unk>.

If they, they were not questions about um, permanent J Code. If we didn't have issues with J Code, they see a permanent job this year. How many patients do you think it would be possible? Um, for you to do those in 2025? So there is, I'm asking because Envision trial, enrolled are very quickly, I think, 2020 patient, 10 months across 90 size. I was trying to understand if we did not have reimbursement. Um, um, reimbursement issues at this point. So, how many patients would it be possible to those 2025?

<unk> reimbursement so that's actually a good thing because we can solve that right. It takes time to solve that but once we start getting explanation of benefits <unk> out there once we start to see what we're hearing from a lot of practices is okay I'll try it on one patient.

Yeah, look that's a great question. Not not.

That we're going.

Typically you wanted to be a Medicare fee for service patient because thats kind of the one that they felt most confident about and then once they get that experience and see a positive reimbursement than theyre more willing to expand beyond to other patients, but I think.

And without speculating on the number it would be significantly more there is no doubt about it and I think the good news is is when you're out there talking to doctors.

That's the question, it's really around reimbursement and not around the clinical.

Usage of our utility our need for this this drug and I think thats, a very tight for us to be.

But um, but it suffices to say that absolutely, it's a significant number of patients. Um, as I mentioned earlier, the number 1, you know, the number 1 barrier right now is reimbursement and it's not around the desire for clinical use and that that's a good. That's a good thing. That's a really good thing. I mean, rarely, do you roll out where there's not question, you know, more questions around the clinical data? Um, the clinical use the patient identification and we're not hearing that, the only the only again, uh, you know, and all the conversations I've had. It's only been around reimbursement. So that's actually a good thing because we can solve that right? Um, it takes time to solve that, but once we start getting explanation of benefits eobs out there, once we they start,

When do you think you'd be able to provide short term and long term guide us for the story.

Just trying to I know that.

Talking about the sort of being overall targeting five below market, but we're also trying to understand what would be the peak sales.

Yes.

Just wanted to understand the level of comparable provider, both short term and long term guidance.

Okay.

Hey, this is Chris Thanks for the question there I mean, I think we've been pretty clear in terms of potential we've use the story as over $1 billion opportunity.

<unk> itself in terms of providing more short term guidance I think we will get through the early initial launch phase this year and look to potentially provide guidance for 2026.

The questions it's really around reimbursement and not around the clinical um you know, usage or utility or need. Um for this uh this drug. And I I think that's a very good place for us to be.

Okay. Thanks, so much.

Thank you thanks, David.

This concludes the question and answer session I would now like to turn it back to Liz Barrett for closing remarks.

Yes, I just wanted to take an opportunity to say thank you to everybody. Thanks for hanging in there with us over the years. It is an exciting time for us.

We're still in the early days, but things are looking great.

Wondering, can you be able to provide, uh, short-term and long-term guidance for the story and just trying to? I, I know that, uh, we're talking about the story being overall targeting 5 billion Market. But we also trying to understand what would be the peak sales. Um, just uh, you know, just monetize on the level of comfortable provided both short-term and long-term guidance for the truck. Yeah.

Excited about kind of where we are and where we ought to be and we will keep you guys posted as as things play out. So thanks, a lot and we appreciate it operator you can disconnect at this moment. Thank you.

Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Hey, this is Chris. Thanks for the question there. I mean, I think we've been pretty clear in terms of peak potential. We've used a story as over a billion dollar opportunity uh by itself. Um in terms of providing more short-term guidance, you know, I think

We'll get through the early initial launch phase this year and and look to potentially provide guidance uh for 2026.

Okay, thanks so much.

Thank you and thanks, Aiden.

This concludes the question and answer session, I would now like to turn it back to Liz Barrett for closing remarks.

Yeah, I just want to take an opportunity to say, thank you to everybody. Thanks for hanging in there with us over the years. It's an exciting time for us. Um, you know, we're still still in the early days, but things are looking great. And we're very excited about kind of where we are, and where we are to be. And, um, you know, we'll keep you guys posted as, um, as things, uh, play out. So, thanks a lot. We appreciate it. Operator can just connect at this moment. Thank you.

Thank you for your participation. In today's conference, this does conclude the program. You may now disconnect

Good day, and thank you for standing by. Welcome to the urogen Pharma, second quarter 2025 earnings call. At this time. 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 1, 1 on your telephone. You will then hear an automated message advising you. Your hand is raised to withdraw your question. Please press star 1 1 again.

Please be advised that today's conference is being recorded, I'd now like to go ahead and hand the conference over to your first Speaker today. Vincent Peron investor relations, Vincent you have the floor.

Thank you, operator. Good morning, everyone, and welcome to youren. Farmer's, second quarter 2025 Financial results and business update conference call.

Earlier this morning, we issued a press release providing an overview of our recent, corporate highlights and financial results for the quarter ended, June 30th 2025.

The press release can be accessed on the investors portion of our website at investors.com.

During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing. Commercialization activities related to Joe Mido and Z's duree, our ongoing and planned clinical trials, commercial and clinical Milestones market and revenue opportunities. Our commercialization strategy and expectations as well as anticipated data regulatory, filings and decisions. This Dury being the primary growth driver for your again, the potential benefits of our products and product candidates future R&D development efforts our corporate goals and 2025 Financial guidance among other things.

You are cautioned not to place undue Reliance on these forward-looking statements and your origin. Disclaims. Any obligation to update these statements?

I'll now turn the call over to Liz.

Thank you. Vincent on June 12th. We achieved a defining milestone for your origin with the FDA approval of the story. For adults with recurrent low-grade intermediate risk non-muslim, invasive, bladder cancer. This was truly a landmark moment for our company and importantly, for the 59,000, annual patients, in the US who faced recurrence and repeat surgeries year after year, with no approved Alternatives. There's Durie is the first and only FDA approved pharmacologic treatment for adults with this disease, and has a potential to fundamentally change. The treatment Paradigm and offer patients, durable, long-term recurrence, and treatment-free living.

We are proud to be leading that shift.

From a rare disease focused company to a scaled multi-product organization.

5 years ago, we launched John Mido for the treatment of low-grade upper tractorul cancer that experience, laid, the foundation for everything we're doing today.

With the duree. We are entering a larger but less complex Market. The total available Market exceeds 5 billion dollars annually and we are well positioned to penetrate the opportunity with our expanded sales team of 82 territories. As of August 1st up from 50 previously, we have an experienced team, which strong knowledge and relationships that will allow us to accelerate and guide the launch of the story.

Our commercial organization has a deep understanding of how care is delivered in your neurology from academic centers to high volume Community practices.

Their established relationships and filled insights position as well for a strong and disciplined launch.

Regarding the commercial launches of the story. The initial focus is on setting up, sites of care and driving clinical convictions. The team is focused on driving early. Adoption among neurologists who previously prescribed young Mido and those willing to initiate treatment before a permanent J code is assigned.

This is a discipline strategic launch built on learning from our first product.

As we move to 2026 with broader reimbursement anticipated, we expect our reach to expand significantly. David will provide more details on the launch in a few minutes.

Turning to John Mido. I'm pleased to report a strong second quarter with net product, revenues of 24.2 million representing an 11% increase over the same period in 2024.

Joe Mito continues to grow with strong underlying demand in the second quarter, demonstrating continued, adoption and usage of this important therapy for patients.

The value proposition of John maider remains clear durable responses, backed by long-term data in real world. Use we are pleased with the results and acceptance received by urologists.

Jurgen's long-term goal is to develop and commercialize a differentiated portfolio of treatments that address meaningful unmet needs across rural, familial, and specialty cancers.

Ugn 301 are anti-ctla for mono. Antibody continues to progress in both monotherapy and combination studies for high-grade, non-muslim invasive, bladder cancer. Meanwhile our next Generation pipeline is advancing.

The Phase 3 Utopia trial of UGM 103 for recurrent low-grade, intermediate-risk, non-muscle-invasive bladder cancer is now fully enrolled. We expect initial complete response data by the end of 2025. We will share this data with the FDA and gain agreement on the path forward to approval.

If the trial is successful, we expect to file an NDA for this product in 2026.

We've also initiated a phase 3 trial in June of 2025 for UGM 104. Our next Generation might Amy based formulation from low-grade, utuc

Our balance sheet remains strong, with 161.6 million in cash, cash equivalents and marketable, securities as of June 30th. We believe we have the necessary Capital to fund this Theory launch while supporting the advancement of our Pipeline and other strategic priorities.

We will be thoughtful about potential opportunities to expand our portfolio for the long term while driving commercial success and profitability goals.

The team at Urgent has demonstrated their dedication and resilience while striving to make a meaningful impact for patients.

To the Urology Community, particularly those participating in research, as well as those publicly advocating support for our medicines, we could not do it without you.

The 2 commercial products in advancing pipeline in the commercial infrastructure to scale. Urine is well positioned for sustainable growth.

We are executing with discipline and purpose and we remain deeply committed to delivering meaningful Innovation for patients and generating value for our shareholders.

I will now turn the call over to Mark Schamberg, mark.

Thank you Liz as a practicing urologist. I've spent years managing patients, with recurrent low-grade. Intermediate risk. Non-muslims of bladder cancer.

And offers a convenient office based outpatient alternative to repeated surgeries. We view this as a significant shift in the standard of care.

Historically Transit, the reception of bladder tumor or turbt has been the only real option for patients with low-grade intermediate risk disease.

Trbt is an invasive surgical procedure. It requires general anesthesia and access to an operating room. And it carries risks, especially in an older population patient certificate, diagnosed with bladder cancer, in their mid-70s. And many of these patients have comorbidities that make surgery under general anesthesia, less than ideal.

We also know this is a highly recurrent disease approximately. 68% of patients experience. At least 2 recurrences and 23% will have 5 or more.

That means multiple surgeries under general anesthesia and an ongoing burden that takes a toll on both physical health and quality of life, not to mention the burden placed on partners, family, and other caregivers. In addition, repeated treatment procedures may be associated with an increased risk of mortality.

The story offers a new non-surgical treatment approach. This story is administered as an intravesical installation via urinary catheter once a week for 6 weeks in a physician's office. No, operating room. No general anesthesia and minimal recovery time.

In many cases a trained nurse. Can perform the procedure right in the neurologist's office.

For patients, this means a much less disruptive experience for medical practices. It means increased or ability for more complex procedures and an efficient in-office option that can streamline treatment delivery.

The clinical data supporting those 3 are both robust and continuing to mature in our ongoing pivotal phase 3, Envision trial 79% of patients achieved a complete response of 3 months following the completion of treatment equally important. However is the durability of that response in bladder cancer. Long-term Disease. Control is what truly improves outcomes and quality of life for patients.

According to the published literature the median duration of response for trbt in this population is approximately 6 to 9 months with a substantial proportion of patients recurring within the first year.

In that trial of the 41 patients who achieved a complete response, the median duration of response was approximately 2 years by Kaplan-Meier estimate. Among the 17 patients who entered the 5-year extension study, the median duration of response was 3.5 years. These data contribute to the growing and consistent body of evidence demonstrating that this is durable, is not only effective in achieving a complete response but also offers durable disease control over time.

We are very optimistic about the emerging long-term durability profile of Zuri.

I'll now briefly update you on the clinical pipeline.

Ugn 301 is our investigational anti-ctla for antibody delivered via RT gel. It is currently being evaluated in a Phase 1, trial both as monotherapy. And in combination with ugn 2011, our tlr7 Agonist and with gemcitabine,

we share the latest data at the AUA meeting in April and the safety profile continues to be favorable, across both the monotherapy and combination arms.

As Liz mentioned earlier, we're also advancing our next-generation formulations, as auri and gel might help.

Current low-grade intermediate risk disease and has completed enrollment this study is modeled closely on Envision. Efficacy will be measured by the complete response rate of 3 months, with follow-up, focused on assessing durability.

We expect Topline complete response data by the end of this year and we plan to share those results with the FDA to help inform the regulatory path forward.

We are also taking a similar approach with ugn 104 our next Generation formulation of General Mito.

We recently initiated a single alarm phase 3 trial in patients screenings on your way.

UGM 501 or recently acquired next Generation on Cally virus candidate is progressing through IND enabling studies with a Phase 1 trial, anticipated to begin next year.

I will now turn the call over to David for the commercial update.

Thank you, Mark.

As my colleagues have shared, we believe the story represents a true shift in how recurrent low-grade intermediate risk. Non-muscle invasive, bladder cancer is treated

Our Focus now is on ensuring that all appropriate patients have access to this story in an accelerated and successful launch.

We have completed the expansion of our sales force. Have you increased the total number of reps from 50 to 82?

With this footprint we believe we are well positioned to reach the 8,500. Healthcare providers, who treat approximately 90% of the addressable patient population

We view the launch in 2 distinct phases.

The first phase covers the period from July through the end of this year.

The second begins on January 1, 2026, when we expect to receive a permanent product-specific J code.

That Milestone will be an important Catalyst for broadening adoption, particularly in the community setting, where reimbursement Logistics, play a critical role in treatment decisions.

During the initial phase, our commercial priorities fall into 3 areas.

Engaging with healthcare providers.

Activating treatment sites and advancing Market access.

First, our field team is focused on building awareness establishing clinical convictions and ensuring providers and staff are educated on how the story will benefit appropriate patients.

Even at this early stage, we are encouraged by the level of interest we're seeing.

Awareness around the story is strong and Healthcare Providers are eager to learn about the profile of the story and engage on appropriate patient types.

Customer questions, focus on the clinical operational, and financial considerations to begin treating with this story.

We are initially focused on a group of roughly 2,000. Physicians out of our total 8,500 Target Universe.

Whom we've identified as likely, early adopters, these are Physicians who have demonstrated a willingness to introduce new therapies during a miscellaneous. J Code period.

Our goal is to engage with the majority of accounts within the first 6 to 8 weeks of launch, and we are making strong progress toward that target.

Our discussions with Physicians are focused on identifying patients, who stand to benefit most from treatment with Zuri.

This typically involves those with multiple prior recurrences and a history of rep, repeated tubes.

Patients experiencing early, recurrences after surgery and patients who may be poor surgical candidates due to comorbidities or other risk factors?

The second area of focus is site activation.

We are working closely with practices and hospitals to ensure operational readiness.

This includes everything from distributor onboarding to clinical training and Pharmacy processes.

As we have noted previously, many providers prefer to initiate the use of new therapies like Zeri in the hospital outpatient setting, where hospital pharmacy budgets are often managed at separate cost centers.

We are supporting this process including working with pnt committees to ensure formulary placement as quickly as possible.

On the market access front. Our team is actively engaged with major payers Nationwide.

At this stage, we have secured open access for approximately 84% of covered lives.

These efforts are Central to the launch and reflect our commitment to ensuring patients can access us Dior without unnecessary, administrative, or financial barriers.

Looking ahead to 2026. The assignment of a permanent J. Code should significantly simplify the reimbursement process.

At that point, we intend to broaden. Our commercial Focus to include a broader segment of the Urology Market including many, more community-based practices.

Drive strong year-over-year unit growth which reflects growing comfort and conviction among urologists.

We see steady growth in both the number of sites of care and the number of new prescribers, and we are encouraged by the positive Trends in patient identification.

The message around durability of response remain Central and continues to resonate and our team is maintaining high frequency engagement with top, performing accounts to sustain momentum and drive further growth.

I will now turn the call over to Chris Denman for a financial update.

Thank you, David. As Liz mentioned earlier, Joe Mito, net product revenues were 24.2 million for the 3-month ended. June 3020 2025 compared with 21.8 million and the same period in 2024 year over year. Revenue. Growth of 11% was driven by underlying demand growth of 7% and price capability as the gross to net rate. For Jomo has stabilized in recent quarters,

R&D expenses for the second quarter of 2025 or 18.9 million including non-cash, share-based compensation, expense of 0.4 million.

This compares to 15.4 million, including non-cash, share-based compensation expense of 0.6 million for the same period in 2024.

The increase in R&D expenses of 3.5 million was primarily driven by higher manufacturing costs for USA story and cost associated with the phase 3, Utopia trial for ugn 103, partially offset by lower clinical trial costs and Regulatory expenses in connection with the story.

Selling General and administrative expenses for the second quarter of 2025 were 43.2 million including non-cash. Share-based compensation expense of 2.3 million

This compares, the 30.1 million, including non-cash, share-based compensation, expense of 3 million for the same period in 2024.

The year-over-year increase of 13.1 million was primarily driven by the story commercial, preparation activities, as well as an increase in overall commercial costs.

We reported non-cash financing expense related to the prepaid forward, obligation to rtw, Investments of 4.6 million in the second quarter of 2025 compared to 5.8 million in the same period in 2024.

interest expense related to the term 1 facility with funds, managed by pharmacon advisors was 4.1 million in the second quarter of 2025,

Compared to 3.5 million in the same period in 2024.

The increase was primarily driven by interest expense related to the third draw on the loan that was funded in September 2024.

we do not intend to draw down the fourth and final tranche 75 million that is available to us at our discretion until August 29th 2025

Net loss was 49.9 million or 1 dollar 5 cents per basic and diluted share in the second quarter of 2025 compared the net loss of 33.4 million or 82 cents per basic and diluted share in the same period in 2024.

as of June, 30, 2025 cash, cash, cash, equivalents and marketable, securities total 161.6 million

Turning now to guidance our full year, guidance for Joe Mido remains unchanged, we continue to expect 4 year 2025 net product revenues from jaido to be in the range of 94 to 98 million.

This implies year-over-year growth of approximately 8% to 12% over the $87.4 million and the management-driven Joe Maider sales in 2024.

This excludes the million dollars and creates sales reported in 2024.

Guidance on full year 2025 operating expenses is also unchanged and is expected to be in the range of 215 to 225 million.

Including non-cash, share-based compensation expense of 11 to 14 million.

We anticipate operating expenses to decrease modestly over the remainder of the Year, reflecting the impact of several non-recurring costs. Incurred, during the first half of the 2025

Partially offset by the sales force expansion in the second half of the year.

These now recurring costs total of approximately 15 million dollars and included expenses related to the acquisition of UGM 501.

Preparations for the zest story odac.

Our national launch meeting for the story.

And Manufacturing expenses for us, our story, which were accounted for as R&D, expense prior to FDA approval.

That concludes our prepared remarks. We are now ready to open the call for questions, operator.

As a reminder, to ask a question, you will need to press *11 on your telephone and wait for your name to be announced to withdraw your question. Please press *11 again and stand by while we compile the Q&A roster.

Our first question comes from Terra Bankrupt. With TD Cohen, Tara, go ahead with your question.

Thanks and and good morning. Thanks for taking the questions. So I have to ask the obligatory first question on all of our minds, um, is there anything that you can offer on metrics you've hit so far for July, like, I mean, script rate number of active accounts or prescribers that you have or really, anything qualitative, like the perceived level of pent-up, demand from those who were maybe waiting to get a TBT to instead receive the story if any um, things like that. Thank you.

Yeah, great question, Tara Heights, Liz. And I'm going to ask, um, David to come in and then I'll probably add some color as well. So David

Engaging physicians. We're, uh, helping them identify sites of care and, importantly, we're also continuing to make sure that market access—um, we lay the groundwork for market access so that, um, all the patients have access to the product per label. So, um, anyway, thank you for the question and, uh, we'll be looking forward to sharing more results in the future. Yeah, I tier a look. Um, I'll give...

You a little bit more color on that 1. We're not going to give, you know, metrics at this point. Um, you know, I'm sure everybody would love to have them but it's still very early for us. What I will tell you is that we've all been spending a lot of time out in the field and talking to doctors and to David's Point. There's a lot of excitement and what you hear from doctors is they all have patience. And I want to sort of, um,

Put a note on patients.

Because, you know, when you launched John Mido, it's like I have a patient. And when we talked to doctors today, they have several patients.

That the biggest hurdle, frankly, is reimbursement, which we knew. I can tell you that I went to an event last week with a lot of community practices and doctors, and the first thing they say is, as soon as you get a permanent J Code, as soon as you get a permanent J Code, I've got it, you know, patients waiting.

We don't and we've always said it would not be a bolus.

Of patients. Um but again, what I can tell you is that our pests are coming in patient enrollment form. So the top of the funnel we're very happy with where we're going there and the team as David said is working on, you know, the sites of care pulling those through, um, you know, dosing, you know, really getting patients dosed. Um, so I would say at this point, we're very optimistic, we feel really good about where we are. We think the, um, consensus is we said for the, for the year, uh, we are still aligned with that and, um,

You know, have the opportunity to to see something real, um, uptake, you know, over the next few months. Um, I do think, uh, David commented, this in the prepared remarks that you will see, um, you know, a acceleration after the first of the year when when we have the J Code, but we have the hospitals, we have institutions and we've got some large practices that are all willing to write. So it's not like no 1's willing to take to, uh, you know, do it during the miscellaneous code. But you do see a big difference in, um, in sort of attitude, kind of before and after. But the good news is, is that all of the, um, the metrics, the feedback we're getting have not talked to 1. Doctor Who said, no, I don't see a role for this and none of them frankly that say they're going to really limit it. Um, you know, so again a lot of excitement,

Around using this and you know multiple patients in their in their practice. So hopefully that extra color helps uh, without giving very specific um, you know, numbers for you. But David also mentioned sites of care. We we have set up a lot of sites of care and we're on track with where we need to be. And the number of sites of care that we already have set up, um, you know, this uh, so far that uh, to deliver what we've um, you know, what we've uh, stated we would deliver for the year so hopefully that helps

Yeah, definitely. That's all very helpful. Thank you so much.

Question.

Our next question comes from Michael Schmidt. With Guggenheim, Michael, go ahead with your question.

Yeah, good morning. Thanks for taking my question.

Um perhaps a a follow-up just on the early line here we certainly had some, you know, very positive feedback from uh your artists as well that that we spoke with in terms of intent to prescribe uh the therapy. But yeah, just curious what you're seeing uh, so far around the reimbursement process early on, you know, using the miscellaneous code. It's just curious if you could, uh, comment, perhaps, how much, uh, time it takes in terms of, you know, intent to prescribe until sort of conversion to, uh, paid prescription. Um, or you know, anything along those lines would be helpful and then I had a follow-up.

Yep, sure, go ahead, David. Yes, thank you for the question, Michael. Um, I'll just comment on the initial process in terms of educating accounts. So as we discussed in our prepared remarks, we are really focused on a group of around 2,000 providers that have demonstrated a willingness to adopt product during this particular period. And so that's just pretty much what we're seeing in terms of Interest right there. 1 of the things we do which um, is very similar to what we did with Joe Mido at that launch, is we spend a good amount of time? Educating them on the actual process for claims and billing and then reimbursement, so we educate.

Them fully on, um, on that. So it's white glove service and with that, they have the reassurance of knowing that they've in the, in when they enroll a patient, they know what that patient's co-pay is going to be, they know what the coverage is going to be, and the office feels uh, more reaffirmed in terms of um how that process is going to work. As you know, with the miscellaneous J Code period. Um it is a little bit of a different process because it's manual but what we're seeing so far is that when we engage the practices um they feel assured that um what they're doing is setting them up for a positive experience.

So it's too early to sort of say, how long is it going to take um, you know, as we start to see that coming through, we'll be able to give you more color on that. But it it's it's too early to see that.

And then I guess if you were to compare the initial experience of the the story launch to your experience with gel Mido 5 years ago. Um, you know, I guess how much commercial strategies are there in place today, you know, given your commercial footprint around the gel Mido product um and you know, any key learnings that um as as you launch the story, essentially into a very similar similar Market here.

Yeah, since, uh, Mark, and I was the only 2 people here. When we launched, um, tomato. I'll give you some comment and asked Mark to add anything. You know, I, I think the

If similar in a lot of ways in the sense of, you know what, what you have to deal with, with the J Code, what you have to do is with reimbursement, which you have to deal with identifying patients. So and what you have to deal with frankly for uh, office to get set up, you know where it's set up with the distributor. The good news is obviously a lot of these offices are already set up. So all we have to do is add

You know, add in this jury where they already were. So so there is a little bit of paperwork. You know, that happens there. Absolutely. Some of the First physicians that we see that are writing far as this Dury are writers of John Mayo. So which makes a lot of sense. Um, and I think the, you know, what we also are seeing is that, you know, for the most part people are really happy with the the, uh, support that we gave them with John Mido and are happy with the support that they're getting again. The Physicians that I've personally interacted with have commented about particularly our reimbursement team because that's the number 1, you know, thing right now and and how how good is, how good they are, how knowledgeable they are, how helpful they are. And then I'm going to let Mark talked about the numbers because I think that's a big big difference between what you what we heard when we launched.

Has been what it has been. That's very different than what we're dealing with with uh, this is a story launch. There are lots of patients who qualify, uh, by the label Alone, um, for the use of this drug and Physicians are exceedingly. Um,

Familiar with the with this population of patients, these are people we're seeing in the office on a very regular basis. So, you know, I do think, although, as Liz pointed out, many of them, sort of mechanical issues related to bringing the drug into the practice, or similar, and will be familiar to people who have used young Mido, the opportunity, the ease of administration. The fact that this can be given in an office with essentially minimal physician involvement. This can be driven by a nurse uh, will really change the way of the Zuri experience. Looks compared to our experience previously, with Joe M lunch.

On Eugene 103. And so, now with the uh, Utopia study fully enrolled, um, I was just curious. Um, if you had the chance to have any additional discussions, uh, with with, with The Regulators in terms of, you know, sort of coming off of the, uh, the panel earlier this year, in terms of, whether the, the study is, in fact, supportive of potential approval and, um, from a, from a clinical perspective, you know, is the go to essentially a reproduce The Envision, uh, data or is their opportunity to differentiate clinically with uh 1 or 3? Uh, thanks so much.

Yeah, no. Great question. Um, we have not interacted it's uh we don't have enough data yet. So we're waiting on additional Data before we interact with the FDA but we will absolutely do that and have uh feedback for you prior to the end of this year. So I think that's the the the timing on that the goal is to replicate and we we actually purposely did that because what we didn't want to do is introduce any potential issues, right? That would that would muddy the waters as far as um as far as the data is concerned. So we tried to replicate almost exactly The Envision study so there, unfortunately, there's no differentiation but fortunately what we're doing is trying not to introduce any biases. Um, our expectation is that the FDA will um, except the study as they had previously communicated, mainly because this is a new formulation and they actually have UGM 102 this Dury as a historical control. Now, um,

So uh we do plan to interact again with them. We'll have feedback for you before the end of the year, but that's our expectation. And that's what we're moving forward with having said that we and ourselves want to continue to expand the use of UGM 103. So we are in the planning of additional life, cycle management studies that we will start fairly quickly on UGM 103, um, you know, regardless of the FDA, uh, feedback. But we have other studies that we want to do.

Do in other populations and we'll, we'll be starting those um, as quickly as possible.

Thank you.

Our next question comes from Leland gershel.

With, Oppenheimer Leland. Go ahead with your question.

Hi. Good morning and thanks for taking our questions a few from from us. Um you know with respect to this first phase of the launch you know pre the um the J Code assignment. 1 thing you know as as you're going after those 2,00 docs you've identified you know it's probably a doctor's. Um can you share what how those breakdown with respect to community versus academic docs? Should we think of the academic those who practice in an academic setting, is maybe having, you know, easier access to the medication is the, you know, miscellaneous. J Code, you know, easier in the hospital setting or through that um, process. Um, is there a TNT committee Dynamic that we should consider for us this jury, uh, in the hospital setting? If you could share, you know, any color around that as we think about, you know, 2025 sales for the the jco kicks in. Thank you.

Yep. Absolutely.

Yeah. Thanks Lynn. Uh, the majority of that 20000 physician. Um, I'll say early adopter list that we've identified reside in the community and there are some in institutional settings and as, you know, some have privileges in hospitals as well. So, when we think about, um, them gaining access to the story, it is, um, they're just

Spectrum in private practice. Um, as we've mentioned, there's historically some hesitation there. And so, what we try to do is help them identify a site of care where they can administer the story for the first time and gain experience. Not often is in a hospital outpatient setting.

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