Q1 2025 UroGen Pharma Ltd Earnings Call
Operator: Hello and welcome to Urogen Pharma first quarter 2025 earnings conference 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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again.
Hello, and welcome to your Gen Pharma first quarter 2025 earnings conference 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 the question during the session you will need to press star one on your telephone.
You will then hear automated message advising your hand is raised.
To withdraw your question. Please press star one again.
Vincent Perrone: I would now like to turn the conference over to Vincent Perrone. You may begin. Thank you, operator.
I would now like to turn the conference over to it's in Pahrump you may begin.
Vincent Perrone: Good morning, everyone. And welcome to Urogen Pharma's first quarter 2025 Financial Results and Business Update Conference. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended March 31, 2025. The press release can be accessed on the investors portion of our website at investors.urogen.com.
Speaker Change: Thank you operator good morning.
Speaker Change: Everyone and welcome to origin <unk> first quarter 2025 financial results and business update conference call.
Speaker Change: Earlier. This morning, we issued a press release, providing an overview of our recent corporate highlights and financial results for the quarter ended March 31 2025.
Speaker Change: The press release can be accessed on the investors portion of our website at investors not euro Gen Dot com.
Vincent Perrone: Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, David Lin, Chief Commercial Officer, and Chris Degnan, Chief Financial Officer. During today's call, we will be making certain forward looking statements. These may include statements regarding our ongoing pre-commercialization activities related to UGN-102, regulatory meetings and decisions, our commercialization strategy and expectations, as well as potential future commercialization activities for UGN-102, if approved, market and revenue opportunities, commercialization activities related to gel mito, our ongoing and planned clinical trials, commercial and clinical milestones, UGN-102 being the primary growth driver for Urogen, future R&D efforts, and our goals in 2025 financial guidance, among others.
Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, David Lim, Chief Commercial Officer, and Kris <unk> Chief Financial Officer.
Speaker Change: During today's call, we will be making certain forward looking statements. These may include statements regarding our ongoing pre commercialization activities related to <unk> 102 rigs.
Speaker Change: Regulatory meetings in decisions, our commercialization strategy and expectations as well as potential future commercialization activities for <unk>, one or two if approved marketed revenue opportunities commercialization activities related to John Michael our ongoing and planned clinical trials commercial and clinical milestones.
Speaker Change: <unk> being the primary growth driver for you or again future R&D efforts and our goals in 2025 financial guidance among other things.
Vincent Perrone: These forward-looking statements are based on current information, assumptions, and expectations that are subject to change.
Speaker Change: These forward looking statements are based on current information assumptions and expectations that are subject to change.
Vincent Perrone: The description of potential risks can be found in our earnings press release and latest SEC disclosure document. You are cautioned not to place undue reliance on these forward-looking statements, and your attendance claims any obligation to update them.
Speaker Change: A description of potential risks can be found in our earnings press release and latest SEC disclosure documents.
Speaker Change: You are cautioned not to place undue reliance on these forward looking statements and European disclaims any obligation to update these statements I'll now turn the call over to Liz Barrett Chief Executive Officer.
Liz Barrett: I'll now turn the call over to Liz Barrett, Chief Executive Officer. Thank you, Vincent, and thank you all for joining us this morning. The new drug application for our lead development stage candidate, UGN-102, is now in the final stages of FDA review. with a PDUFA target date of June 13. We designed UGM-102 as a novel and innovative treatment for patients with low-grade, intermediate-risk, non-muscle-invasive bladder cancer. We believe UGM 102 has the potential to change the treatment paradigm and meaningfully improve the standard of care in this patient population. If approved, UGM 102 will be the primary growth driver for our company and alongside Gemmido could solidify our leadership in the urothelial cancer.
Thank you Vincent and thank you all for joining US. This morning, the new drug application for our D development stage candidate you. Jan 102 is now in the final stages of FDA review, where they produce a target date of June 13th we designed to you Jan one or two is a novel and innovative treatment.
Speaker Change: For patients with low grade intermediate risk non muscle invasive bladder cancer, we believe U G M. One or two has the potential to change the treatment paradigm and meaningfully improve the standard of care in this patient population.
Speaker Change: If approved <unk> will be the primary growth driver for our company and alongside John might or could solidify our leadership in the year old failure cancer space.
Liz Barrett: Advancing our mission to bring innovative, patient-centered solutions to urologic cancer. We have been informed by the FDA that an Oncologic Drugs Advisory Committee, or ODAC, meeting has been scheduled for UGM 102 on May 21st. This is consistent with our expectations, and we look forward to the opportunity to showcase the strength and consistency of our clinical data to the members of the panel and the public. We have been preparing for the ODAT meeting and believe we are well prepared to present a clear, compelling, and scientifically robust case supporting the approval of UGM 102. In parallel, our regulatory team continues to engage regularly with the agency and has been responding to their information requests.
Speaker Change: Advancing our mission to bring innovative patient centric solutions to Urologic cancers.
Speaker Change: We have been informed by the FDA that an oncologic drugs Advisory Committee or <unk> meeting has been scheduled for AGM, one or two on May 21st. This is consistent with our expectations and we look forward to the opportunity to showcase the strength and consistency of our clinical data to the members.
Speaker Change: The panel and the public.
Speaker Change: We have been preparing for the <unk> meeting and believe we are well prepared to present, a clear compelling and scientifically robust case supporting the approval of <unk> in one or two.
Speaker Change: In parallel our regular regulatory team continues to engage regularly with the agency and it has been responding to their information requests.
Liz Barrett: To date, we've encountered no resource or policy-related issues that concern us. The UGN 102 NDA is supported by a robust development program demonstrating meaningful complete response rate, durable responses, and an acceptable safety profile across three late-stage clinical trials. In March, we reported updated data from the Pivotal and VISION trial, demonstrating that 80.6% of patients who achieved ACR at three months remained in response at 18 months per Kaplan-Meyer estimate. It's important to highlight that these robust results are with UGM-102 alone and not following a transurethral resection of bladder tissue. Additionally, there are six weekly installations. Then patients are treatment-free until recurrence.
Speaker Change: To date, we've encountered no resource or policy related issues that concern us.
Speaker Change: Thank you Jan one or two NDA is supported by a robust development program demonstrating meaningful complete response rate durable responses and an acceptable safety profile across three late stage clinical trials.
In March we reported updated data from the pivotal envision trial, demonstrating that 86% of patients who achieved a CR at three months remainder response at 18 months per Kaplan Meier estimate.
Speaker Change: It's important to highlight that these robust results or with Eugene and one or two alone and not following a transfer refill resection bladder tumor.
Speaker Change: Additionally, there are six weekly installations, then patients are treatment free until recurrence as Mark will highlight these results along with a broader update on Eugene M 102, and Yamato were shared with the urology community at this years <unk> meeting underscoring our clinical leadership and commit.
Liz Barrett: As Mark will highlight, these results, along with the broader update on UGM-102 and GELMITO, were shared with the urology community at this year's AUA meeting, underscoring our clinical leadership and commitment to advancing innovation in uro-oncology. With a PDUFA date goal approximately one month away, a commercial team has been actively preparing for the potential launch of UGM 102. This launch would mark a pivotal moment in Urgen's evolution from a rare disease-focused company to a scaled, multi-product team positioned to serve a significantly broader patient population. We're expanding our commercial footprint accordingly with plans to grow our sales force from approximately 50 reps today to over 80 at launch.
Net to advancing innovation in euro oncology.
Speaker Change: With a <unk> date goal approximately one month away our commercial team has been actively preparing for the potential launch of <unk> to.
Speaker Change: This launch with Mark a pivotal moment in your origins evolution from a rare disease focused company to a scaled multi product team position to serve a significantly broader patient population, we're expanding our commercial footprint accordingly with plans to grow our sales force from approximately 50 reps today.
Speaker Change: To over 80 at launch our medical Affairs and market access teams are also deeply engaged in prelaunch planning where.
Liz Barrett: Our medical affairs and market access teams are also deeply engaged in pre-launch planning. We are targeting commercial readiness by June, and we will be ready to promote immediately following approval with product availability in July. UGM 102 represents a transformative growth opportunity for Urogen. We estimate an addressable population of approximately 60,000 patients annually with recurrent, low-grade, intermediate-risk, non-muscle-invasive bladder cancer. Translating to a market opportunity of over $5 billion. This is nearly 10 times larger than the Jelmido Market. Critically, this market is highly accessible. Unlike the more fragmented UTUC setting. NMIBC patients are widely distributed and primarily managed by community urologists across the country.
Speaker Change: We're targeting commercial readiness by Jim and we will be ready to promote immediately following approval with product availability in July.
Speaker Change: Eugene and one or two represents a transformative growth opportunity for your Gen. We estimate an addressable population of approximately 60000 patients annually with recurrent low grade intermediate risk non muscle invasive bladder cancer translating to a market opportunity of over $5 billion. This is.
Speaker Change: Nearly 10 times larger than the gyro market critically this market is highly accessible unlike the more fragmented you tuc setting.
Speaker Change: <unk> patients are widely distributed and primarily managed by community urologists across the country.
Liz Barrett: UGM 102 is well aligned with current clinical workflows. It's easy to administer, does not require specialized equipment, and can be delivered by a nurse with minimal additional training. We believe these advantages position UGM-102 to become a foundational therapy in the management of low-grade, intermediate-risk, non-muscle-invasive bladder cancer and a significant driver of long-term value creation for urogen.
Speaker Change: You Jan one or two is well aligned with current clinical workflows, it's easy to administer does not require a specialized equipment and can be delivered by a nurse with minimal additional training.
Speaker Change: We believe these advantages position Eugene wanted to become a foundational therapy in the management of low grade intermediate risk non muscle invasive bladder cancer and a significant driver of long term value creation for your gen.
Liz Barrett: Turning to Gemido, we reported $20.3 million in first quarter sales and 8% year-over-year growth compared to the first quarter of 2024, driven by underlying demand growth of 12%. We continue to advance our pipeline across multiple fronts, including our next-generation programs for gelmido and UGM-102, as well as our emerging immuno-oncology initiatives.
Speaker Change: Turning to <unk>, we reported $23 million in first quarter sales and 8% year over year growth compared to the first quarter of 2024, driven by underlying demand growth of 12%.
Speaker Change: We continue to advance our pipeline across multiple fronts, including our next generation programs for <unk> and <unk> in one or two as well as our emerging immuno oncology initiatives.
Liz Barrett: In February, we acquired product candidate ICVB1042, a next-generation investigational oncolytic virus from Iconivir, which we have assigned an internal code name of UGN501. This is an important step in expanding our presence in immune-based therapies for urologic cancer. In parallel, we also have multiple strategic research collaborations in place aimed at leveraging our proprietary RTGEL technology to enhance the delivery and effectiveness of various existing drugs. Urogen is executing with focus and discipline.
Speaker Change: In February we acquired product candidate ICB $10 42, a next generation investigational alkylating fibers from economy here, which we have assigned an internal codename abuse and 501.
This is an important step in expanding our presence in immune based therapies for Urologic cancers.
Speaker Change: In parallel we also had multiple strategic research collaborations in place aimed at leveraging our proprietary Archie gel technology to enhance the delivery and effectiveness of various existing drugs.
Speaker Change: Urogenital executing with focus and discipline, we remain committed to transforming the treatment landscape in euro oncology and are supported by a strong balance sheet with just over $200 million in cash cash equivalents and marketable securities as of March 31.
Liz Barrett: We remain committed to transforming the treatment landscape in uro-oncology and are supported by a strong balance sheet with just over $200 million in cash, cash equivalents and marketable securities as of March 31st. We are investing in innovation with purpose, driven by the opportunity to make a meaningful impact on patients while delivering value to our shareholders.
Speaker Change: We are investing in innovation with purpose driven by the opportunity to make a meaningful impact on patients while delivering value to our shareholders.
Mark Schoenberg: I will turn the call over to Mark Schoenberg, who will provide a clinical update. Thank you, Liz. I would like to echo what Liz shared regarding the strength of the clinical data supporting UGN-102. We've assembled a compelling and comprehensive clinical package that we believe demonstrates both the safety and efficacy. of UGN 102. This gives us a high level of confidence as we approach the upcoming ODAC meeting and the PDUFA target.
I will turn the call over to Mark Schoenberg, who will provide a clinical update mark.
Mark Schoenberg: Thank you Liz.
Speaker Change: I would like to Echo what Liz shared regarding the strength of the clinical data supporting <unk> and one or two we've assembled a compelling and comprehensive clinical package that we believe demonstrates both the safety and efficacy of UGI and one or two.
Speaker Change: This is a high level of confidence as we approach the upcoming <unk> meeting.
Mark Schoenberg: This year's AUA was an important event for Urogen. It provided a valuable platform to present the latest data on UGN-102 and gelmito with the broader urologic community. We were proud of the six abstracts accepted, reflecting the growing body of evidence behind our programs and the continued momentum of our clinical efforts. The highlight was the updated 18-month duration of response data from the Phase III InVision trial, which, as you know, is the pivotal trial that is the foundation of our NDA for UGN 102. The data were featured in a podium presentation by Dr. Sandip Prasad, the principal investigator on the study.
Speaker Change: Target date.
Speaker Change: This year's anyway was an important event for your origin. It provided a valuable platform to present, the latest data on Jan one or two and Yamato with the broader Urologic community. We were proud of the six abstracts accepted reflecting the growing body of evidence behind our programs and the continued momentum of our clinical efforts.
The highlight was the updated 18 month duration of response data from the phase III envision trial, which as you know is the pivotal trial that is the foundation of our NDA for <unk> 102.
Speaker Change: The data were featured in a podium presentation by Dr. Sandy Prasad the principal investigator on the study.
Mark Schoenberg: We are highly encouraged by the continued durability of response observed in the Phase III InVision trial. Among patients who achieved a complete response, the duration of response at 18 months remains strong at 80.6% by Kaplan-Meier estimates. Median follow-up time has now extended to 18.7 months post three-month CR, up from 13.8 months at the previous data cut, and the median duration of response has still not been reached. For reference, the 12-month duration of response was previously reported at 82.5%. These results continue to reinforce the potential of UGN-102 to offer a durable, non-surgical treatment approach for patients with recurrent low-grade intermediate risk and MIBC.
Speaker Change: We are highly encouraged by the continued durability of response observed in the phase III envision trial, among patients who achieved a complete response.
Speaker Change: <unk> responds to 18 months remains strong at 86% by Kaplan Meier estimate median follow up time has now extended to $18 seven months post three months CR up from $13 eight months at the previous data cut and the median duration of response has still not been reached for reference the 12.
Speaker Change: Month duration of response was previously reported at 82, 5%.
Speaker Change: These results continue to reinforce the potential of <unk> in one or two to offer a durable non surgical treatment approach for patients with recurrent low grade intermediate risk <unk>.
Mark Schoenberg: We also presented a poster featuring patient-reported outcomes from the three late-stage UGN-102 studies, OPTIMA-2, ATLAS, and ENVISION. These assessments use the EORTC 24-item Quality of Life Questionnaire specific to NMIBC to evaluate the symptom burden and overall health status. Timings were consistent across trials, showing that treatment with UGN-102 did not negatively impact symptom burden, patient function, or quality of life, an important consideration for a novel therapy intended for use in routine clinical practice.
Speaker Change: We also presented a poster featuring patient reported outcomes from the three late stage <unk> in one or two studies Optima II Atlas and envision.
Speaker Change: These assessments use the EUR <unk> 24 item quality of life question specific to <unk> to evaluate the symptom burden and overall health status and function. The findings were consistent across trials showing that treatment with <unk> in one or two did not negatively impact symptom burden patient function or quality of.
Speaker Change: Like an important consideration for a novel therapy intended for use in routine clinical practice.
Mark Schoenberg: At the AUA, we also shared data from the Phase 1 Dose Escalation Study of UGN-301, our investigational anti-CTLA-4 antibody delivered via RT-GEL. These results were previously presented at SUO in late 2024 and continue to support a favorable safety profile for UGN-301, both as monotherapy and in combination with UGN-201, our TLR7 agonist, and with gem-siting. We observed clinical responses in both the monotherapy and combination arms with follow up on the combination arms ongoing to evaluate durability.
Speaker Change: At <unk>, we also shared data from the phase one dose escalation study of <unk> 301, our investigational anti <unk> four antibody delivered via our T gel.
Speaker Change: These results were previously presented at suo late 2024, and continue to support a favorable safety profile for <unk> 301, both as monotherapy and in combination with <unk> hundred one our telos seven agonist and with Gemcitabine.
Speaker Change: We observed clinical responses in both the monotherapy and combination arms with follow up on the combination arms ongoing to evaluate durability of response.
Mark Schoenberg: We expect to share updated data from this program later this At that point, we anticipate being in a position to make a go-no-go decision on whether to advance UGN 301 into Phase 2 development. Our next generation candidates are actively advancing through development.
Speaker Change: We expect to share updated data from this program later this year.
Speaker Change: At that point, we anticipate being in a position to make a go no go decision on whether to advance <unk> 301 into phase III development.
Speaker Change: Our next generation candidates are actively advancing through development.
Mark Schoenberg: Enrollment is ongoing in the Phase 3 Utopia trial, which is evaluating UGN 103 in patients with recurrent low grade intermediate risk NMID. Utopia is a single-arm, multi-center study modeled on the ENVISION trial. Efficacy will be measured by complete response at three months, following treatment, with follow-up focused on assessing durability. Enrollment is progressing ahead of plan, and we expect a complete enrollment by the middle of this year, with top-line data anticipated in 2026. We are taking a similar approach with UGN 104, our next generation formulation of gel mito, and expect to commence a single-arm Phase III study by mid-year this year.
Enrollment is ongoing in the phase III Utopia trial, which is evaluating <unk> 103 in patients with recurrent low grade intermediate risk <unk>, Utah.
Speaker Change: Utopia as a single arm multicenter study modeled on the envision trial efficacy will be measured by complete response at three months following treatment with follow up focused on assessing durability enrollment is progressing ahead of plan and we expect to complete enrollment by the middle of this year with top line data anticipated in 2026.
Speaker Change: We are taking a similar approach with UGI and 104, our next generation formulation of <unk> and expect to commence a single arm phase III study by mid year. This year.
David Lin: Now, over to David Lin for a commercial update. Thank you, Mark. Our organization is now fully engaged in the final stages of pre-launch activities for UGM 102. The goal is to deliver a seamless and impactful launch that will ensure timely access for patients as soon as possible following approval. Our team is highly energized, and we have the necessary experience, resources and talent to drive adoption.
David Lim: Now over to David Lim for a commercial update.
David Lim: Thank you Mark.
David Lim: Our organization is now fully engaged in the final stages of prelaunch activities for UGI and wanted to the.
Speaker Change: The goal is to deliver a seamless and impactful launch that will ensure timely access for patients as soon as possible following approval.
Speaker Change: Our team is highly energized and we have the necessary experience resources and talent to drive adoption.
David Lin: Our clinical data supports our conviction that UGN 102 can be a transformative product that will change the standard of care in recurrent, low-grade, intermediate-risk, non-muscle-invasive bladder For more information visit www.UGN.org There are three ongoing activities that I want to highlight. First, our medical affairs team is leading an educational effort, engaging directly with urologists to highlight the unmet needs in recurrent low-grade intermediate risk, NMIBC, and ensure strong awareness of the clinical evidence supporting UGN 102. Second, we are scaling the organization to capture a larger opportunity in low-grade intermediate risk, non-muscle invasive bladder. This includes expanding our sales force from approximately 50 reps today to over 80 at launch.
Speaker Change: Our clinical data supports our conviction that Eugene one or two can be a transformative product that will change the standard of care and recurrent low grade intermediate risk non muscle invasive bladder cancer.
Speaker Change: There are three ongoing activities that I want to highlight.
Speaker Change: First our medical affairs team is leading an educational effort engaging directly with neurologists to highlight the unmet needs in the.
Speaker Change: Current low grade intermediate risk and it might be C and ensure strong awareness of the clinical evidence supporting <unk> in one or two.
Speaker Change: Second we are scaling the organization to capture a larger opportunity in low grade intermediate risk non muscle invasive bladder cancer.
Speaker Change: This includes expanding our sales force from approximately 50 reps today to over <unk> launch.
David Lin: We are also building out the rest of the commercial infrastructure, including a robust patient support and distribution network.
Speaker Change: We are also building out the rest of the commercial infrastructure, including a robust patient support and distribution network.
David Lin: Third, we are executing a focused payer engagement strategy. Our market access and medical affairs teams are actively engaging with payers and formulary decision makers to communicate the clinical data supporting UGN 102. We recognize that timely access can make a meaningful difference for patients, and our goal is to ensure coverage decisions are aligned closely with approval to support rapid adoption. If approved, UGN 102 will launch with a temporary miscellaneous J-code, and we anticipate securing a permanent product-specific J-code by January 2026, which will be particularly important for broad adoption in the community setting. In the first six to nine months, our strategy is to focus on a defined group of urologists who have demonstrated a willingness to adopt new therapies during the miscellaneous J-code period.
Speaker Change: Third we are executing a focused payer engagement strategy, our market access and medical affairs teams are actively engaging with payers and formulary decision makers to communicate the clinical data supporting <unk> and one or two with.
Speaker Change: We recognize the timely access to make a meaningful difference for patients and our goal is to ensure coverage decisions are aligned closely with approval to support rapid adoption.
Speaker Change: If approved <unk>, one or two we will launch with a temporary miscellaneous J code and we anticipate securing a permanent product specific J code by January 2026, which will be particularly important for broad adoption in the community setting.
Speaker Change: In the first six to nine months our strategy is to focus on a defined group of urologists, who have demonstrated a willingness to adopt new therapies. During the miscellaneous J code period. We are also working to identify affiliate sites of care for these physicians to help facilitate access and to support product administration.
David Lin: We are also working to identify affiliate sites of care for these physicians to help facilitate access and to support product administration. Our experience with Jalmito, along with recent customer insights, tells us that many providers prefer to initiate use of new therapies in the hospital outpatient setting, where pharmacy budgets are often managed as separate cost centers. During this initial phase, our goal is to establish a strong foundation for UGM 102 adoption, positioning us for broader expansion once the permanent J code is in place. As we enter the final phase of pre-launch execution, we do so with a confidence and momentum.
Speaker Change: Our experience with gel motto, along with recent customer insights tells us that many providers.
Speaker Change: <unk> to initiate use of new therapies in the hospital outpatient setting.
Speaker Change: Where pharmacy budgets are often managed as separate cost centers.
Speaker Change: During this initial phase our goal is to establish a strong foundation for <unk> in one or two adoption positioning us for broader expansion once the permanent J code is in place.
Speaker Change: As we entered the final phase of prelaunch execution, we do so with a confidence and momentum.
David Lin: The interest from the healthcare community in UGN 102 has been very encouraging, and we are implementing a robust strategy to support its introduction.
Speaker Change: The interest from the health care community and Eugene on one or two has been very encouraging and we are implementing a robust strategy to support its introduction.
David Lin: Now turning to Gelmido, first quarter sales were $20.3 million, with demand continuing to grow at a double digit pace. We remain focused on high frequency engagement with our top performing accounts. As we scale our commercial organization in preparation for the anticipated launch of UGN 102, our expanded sales force will also support continued promotion of Jelmido. This integrated effort will allow us to deliver broader utilization across both products while maximizing the impact of our commercial infrastructure.
Speaker Change: Now turning to <unk> first quarter sales were $23 million.
Speaker Change: With demand continuing to grow at a double digit pace we remain.
Speaker Change: <unk> focused on high frequency engagement with our top performing accounts as.
Speaker Change: As we scale, our commercial organization in preparation for the anticipated launch of <unk> in one or two.
Speaker Change: Our expanded Salesforce will also support continued promotion of John <unk>.
Speaker Change: This integrated effort will allow us to deliver broader utilization across both products, while maximizing the impact of our commercial infrastructure.
Chris Degnan: I will now turn the call over to Chris Degnan to review our financial results. Thank you, David. Jomito net product revenues were $20.3 million and $18.8 million for the three months ended March 31, 2025 and 2024 respectively. year-over-year revenue growth of 8% was driven by underlying demand growth of 12%. partially offset by higher 340B charge. The growth to net rate for Jomito has stabilized in recent quarters, and we expect resulting headwinds on year-over-year growth to be less impactful going forward.
Speaker Change: I will now turn the call over to Chris Degner to review our financial results.
Speaker Change: Yes.
Speaker Change: Thank you David Joe might have net product revenues were $20 3 million and $18 8 million for the three months ended March 31, 2025, and 2024, respectively.
Speaker Change: Year over year revenue growth of 8% was driven by underlying demand growth of 12%.
Speaker Change: Partially offset by higher 340, b charge backs.
Speaker Change: And that rate for Joe Mandato has stabilized in recent quarters, and we expect resulting headwinds on year over year growth to be less impactful going forward.
Chris Degnan: R&D expenses for the first quarter of 2025 were $19.9 million, including non-cash, share-based compensation expense of $0.6 million, as compared to $15.5 million, including non-cash, share-based compensation expense of $0.5 million for the same period in 2024. The year-over-year increase in R&D expenses was primarily driven by the equity consideration issued to Iconivere for the acquisition of UGN 501, which was expensed in the quarter, higher manufacturing costs, and costs associated with the Phase III Utopia trial for UGN 103, partially offset by lower clinical trial costs and regulatory expenses in connection with UGN 102.
Speaker Change: R&D expenses for the first quarter of 2025 were $19 9 million, including noncash share based compensation expense of zero point $6 million as compared to $15 $5 million, including noncash share based compensation expense of <unk> 5 million for the same period in <unk>.
Speaker Change: 2020 for.
Speaker Change: The year over year increase in R&D expenses was primarily driven by the equity consideration issued to icon of your for the acquisition of <unk> 501, which was expense in the quarter higher manufacturing costs and costs associated with the phase III <unk> trial for <unk> 103, partially offset by lower clinical trial.
Speaker Change: Costs and regulatory expenses in connection with Eugene one or two.
Chris Degnan: Selling general and administrative expenses for the first quarter of 2025 were $35 million, including non-cash share-based compensation expense of $2.5 million. This compares to $27.3 million, including non-cash, share-based compensation expense of $2.2 million for the same period in 2024. The year-over-year increase was primarily a result of UGN 102 commercial preparation activity.
Speaker Change: Selling general and administrative expenses for the first quarter of 2025 or $35 million.
Speaker Change: Noncash share based compensation expense of $2 5 million.
Speaker Change: This compares to $27 3 million.
Speaker Change: Noncash share based compensation expense of $2 2 million for the same period in 2024.
Speaker Change: Year over year increase was primarily a result of new Gen, one or two commercial preparation activities.
Chris Degnan: We report a non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.6 million in the first quarter of 2025, compared to $5.7 million in the same period in 2024. Interest expense related to the $125 million term loan facility with funds managed by Pharmacon Advisors was $4.1 million in the first quarter of 2025, compared to $2.4 million in the same period in 2024. The increase was primarily driven by interest expense related to the $25 million third tranche of the loan that was funded in September 2024.
Speaker Change: We reported non cash financing expense related to the prepaid forward obligation to RTW investments of $4 $6 million in the first quarter of 2025 compared to $5 7 million in the same period in 2024.
Speaker Change: Interest expense related to the $125 million term loan facility with funds managed by pharma kind of advisors was $4 $1 million in the first quarter of 2025.
Speaker Change: <unk> to $2 4 million in the same period in 2024.
Speaker Change: The increase was primarily driven by interest expense related to the $25 million third tranche of the loan that was funded in September 2024.
Chris Degnan: Net loss was $43.8 million or $0.92 per basic and diluted share in the first quarter of 2025 compared with a net loss of $32.3 million or $0.87 per basic and diluted share in the same period in 2024. As of March 31, 2025, cash, cash equivalents, and marketable securities totaled $200.4 million.
Speaker Change: Net loss was $43 8 million or <unk> 92 per basic and diluted share in the first quarter of 2025.
Speaker Change: Paired with a net loss of $32 $3 million or <unk> 87 per basic and diluted share in the same period in 2024.
Speaker Change: As of March 31, 2025, cash cash equivalents and marketable securities totaled $204 million.
Chris Degnan: Turning now to guidance. We last provided financial guidance with our year-end 2024 results in March, and that guidance remains unchanged. We continue to expect full-year 2025 net product revenues from Gelmido to be in the range of $94 to $98 million, and this implies a year-over-year growth rate of approximately 8 to 12 percent over the $87.4 million in demand-driven Gelmido sales in 2024.
Speaker Change: Turning now to guidance, we last provided.
Speaker Change: <unk> financial guidance with our year end 2024 results in March and that guidance remains unchanged.
Speaker Change: To expect full year 2025, net product revenues from <unk> to be in the range of <unk> $94 million to $98 million in.
Speaker Change: This implies a year over year growth rate of approximately 8% to 12% over the $7 4 million and the ban driven Joe might owe sales in 2024, which excludes the $3 million in <unk> sales reported in 2024.
Chris Degnan: Excludes the $3 million in CrateSac sales reported in 2024. Guidance on full-year 2025 operating expenses is also unchanged. It is expected to be in the range of $215 to $225 million, including non-cash share-based compensation expense of $11 to $14 million.
Speaker Change: Guidance on full year 2025 operating expenses is also unchanged and is expected to be in the range of $215 million to $225 million, including noncash share based compensation expense of $11 million to $14 million.
Operator: We're now ready to open the call for questions, operator. Thank you. Ladies and gentlemen, as a reminder to ask a question, please press star 1-1 on your telephone, then 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.
Speaker Change: We're now ready to open the call for questions operator.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen, as a reminder to ask a question. Please press star one on your telephone.
Speaker Change: For your name to be announced.
To withdraw your question. Please press star one again.
Speaker Change: Standby, while we compile the Q&A roster.
Tara Bancroft: Our first question comes from the line of Tara Bancroft with T-Day Cohen. Your line is open. Hi, good morning, and thanks for taking the questions.
Speaker Change: Our first question comes from the line of Tower Bancroft with D. J Cohen Your line is open.
Tower Bancroft: Hi, good morning, and thanks for taking the question. So I was hoping that you know in.
Liz Barrett: So I was hoping that, you know, in light of today's events, can you possibly give us the breakdown of Medicare and Medicaid exposure that you anticipate for UGN one on two and, and currently for Jelmido, really how you think pricing dynamics could play out? Thanks so much.
In light of today's event can you, possibly give us the breakdown of Medicare and Medicaid exposure that you anticipate for UGI, we wanted to and current link for Jim I know really how do you think pricing dynamics could play out. Thanks, so much.
David Lin: Yeah, hi, Tara, it's Liz. And I'll ask David to comment on that in a moment when thinking about the percent of our business. But keep in mind that we're only a U.S. focused company. So we don't have any issues from a best price perspective, favored nation perspective outside. So we don't we don't have any risk associated with that.
Speaker Change: Yes, Hi, Tera sleds, and I'll ask David to comment on that in a moment when thinking about the percentage of our business but.
Speaker Change: Keep in mind that we are only a U S focused company. So we don't have any issues from a best price perspective.
Speaker Change: Nation perspective.
Speaker Change: So we don't we don't have any risk associated with that but David can you just talk about the Medicare.
Operator: But David, can you just talk about the Medicare? Yeah, hi, Tara, it's David. We anticipate that the Medicare population will comprise about 70% of our business, very consistent with the overall patient demographic in low grade intermediate risk and MIBC. And as we think about a launch, our principal priority will also be to drive reimbursement confidence with the providers who treat these patients. Thanks very much for the question. Appreciate it. Yeah, thank you. Please stand by for our next question.
David: Yes, Hi, Tera its David we anticipate that the Medicare population will comprise about 70% of our business very consistent with the overall.
David: Patient demographic and low grade intermediate risk and it might be you see and as we think about a launch our principle priority. We will also be to drive reimbursement confidence with the providers who treat these patients. Thanks very much for the question I appreciate it.
David: Yes. Thank you.
David: Please standby for our next question.
Kelsey Goodwin: Our next question comes from the line of Kelsey Goodwin with Guggenheim. Your line is open. Oh, hey, good morning. Thanks for taking my question. Congrats on getting one step closer to this exciting approval.
Speaker Change: Our next question comes from the line of Kelsey Goodwin with Guggenheim. Your line is open.
Kelsey Goodwin: Oh, Hey, good morning, and thanks for taking my question and congrats on getting one step closer to this exciting approval in.
Liz Barrett: In terms of preparing for the ODAC, I guess, how are you preparing? And where do you expect the most pushback from the panel? And what do you think are your strongest arguments there? Thank you. Yeah.
Speaker Change: In terms of preparing for the <unk>.
Speaker Change: How are you preparing and where do you expect the most pushback from the panel and what do you think are your strongest arguments there. Thank you.
Liz Barrett: Hi, Kelsey, it's Liz. Thanks for the question. We have been preparing for quite a few months, frankly, since last fall. We have had our mock ODAC panels. We've had several now. We've had them with distinguished guests that are medical oncologists that have been on ODAC, statisticians. So what we've tried to do is really have a situation where it's just like if we were at the ODAC. So a lot of the members have been ODAC members in the past. Some have even been leaders of the ODAC. So we feel like we've really put ourselves through the paces, and we will continue to do so up until the day of the ODAC.
Kelsey Goodwin: Yeah, Hi, Kelsey plus further.
Speaker Change: Further question, we have been preparing for quite a few months frankly since last fall we have had our mark.
Kelsey Goodwin: <unk> panels, we've had several now we've had them with <unk>.
Speaker Change: English guest that we have our medical oncologists that have been on <unk>.
Speaker Change: Statisticians, so what we've tried to do.
Speaker Change: It's really have a situation where we are.
Speaker Change: It's just like Uber at the Kodak. So a lot of the members have been members in the past some have even been leaders of the <unk>.
Speaker Change: So we feel like we've really put ourselves through the paces and we will continue to do so up until the day of the <unk>.
Liz Barrett: I'm going to give my perspective, and then I'm going to turn it over to Mark and ask him to comment as well. So my perspective is that the biggest question is around the fact that Envision is a single-arm study. It's the basis for an approval, for our approval, and how do the results, how do you compare those results? How do you put them in context? So in other words, it sounds great, right? Your 80% sounds great, and your 80%, it sounds great, but I don't have anything to compare it to. And unfortunately, with the exception of our own study, Atlas, and we can talk about sort of the challenges with Atlas, but except for our own study, Atlas, there hasn't been a lot of peer-reviewed studies or data published in this specific patient population, the low-grade intermediate risk non-muscular basal bladder cancer.
Speaker Change: Im giving you my perspective.
Speaker Change: And then I'm going to turn it over to Mark and ask him to comment as well. So my perspective is that the biggest question is around the fact that envision is a single arm study, it's the basis for an approval for our approval and how did the results. How do you compare those results how do you put them in context. So another.
Speaker Change: The words.
Speaker Change: It sounds great right Youre, 80% sounds great in your 80% it sounds great, but I don't have anything to compare it to and unfortunately and the with the exception of our on study Atlas and we can talk about sort of the challenges with Atlas, but except for our own study Alex there hasnt been a lot of peer reviewed.
Speaker Change: Studies are data published in this specific patient population.
Speaker Change: The low grade intermediate risk non motor based on bladder cancer. So it's really about putting it in context and how do you take a single arm study and put the data in context, having said that we obviously feel really good about it and I can tell you that and our mock <unk>, we've gotten positive vote, that's where it comes down to.
Mark Schoenberg: So it's really about putting it in context, and how do you take a single-arm study and put the data in context? Having said that, we obviously feel really good about it. And I can tell you that in our mock ODACs, we've gotten a positive vote. That's where it comes down to, and we are not dealing with people who are being easy on us, trust me. And we give our presentation, we give an FDA presentation, we give them a briefing book. So again, we try to simulate an ODAC meeting. And ultimately, in those situations, we have come out with a positive vote.
Speaker Change: And we are not dealing with people who are being easy on US Trust me.
Speaker Change: And we give our.
Speaker Change: Our presentation will be given FDA presentation.
Give them a briefing book, so again, we try to simulate a node at meeting.
Mark Schoenberg: And ultimately in those situations, we have come out with a positive vote, but mark do you will you comment one the second part of <unk> question, which is why we feel good about where we are and what our arguments are and any other comments you have around you think potential challenges.
Mark Schoenberg: But Mark, will you comment, one, at the second part of Kelsey's question, which is why we feel good about where we are, and what our arguments are, and any other comments you have around, you think, potential challenges? Sure. Thanks, Liz. So the evidence we've got for starters, and actually this came out of extensive conversations with the FDA in preparation for this meeting, are the fact that, as everybody listening probably remembers, we are working in a recurrent population. So the population we're treating and talking about in this meeting are patients who've already I think one of our strongest arguments is that we have great results in a population of patients who didn't do well with the standard of care.
Mark Schoenberg: Sure. Thanks Louis.
Okay.
Mark Schoenberg: So we've got for starters.
Speaker Change: This came out of extensive conversations with the FDA in preparation for this meeting.
Mark Schoenberg: The fact that.
Mark Schoenberg: As already listening probably remembers we are working in a recurrent population. So the population, we're treating and talking about in this meeting are patients who've already.
Mark Schoenberg: Had surgery and who have recurred. So the agency identified this as the greatest unmet medical need and we completely agree. These are patients who have failed standard of care and then they receive treatment primary treatment as was said with Aegean one of them.
Mark Schoenberg: Two and achieved.
Mark Schoenberg: 80% complete response rate.
Mark Schoenberg: The profile and 18 months later.
Over 80% Euro ability of that complete response. These are from a clinical perspective remarkable result.
Thank you I think one of our strongest arguments is that we have great results in a population of patients who didn't do well with the standard of care. So that's number one and I think our experience with the mock panels as loose as pointed out has been favorable precisely because of the encouraging safety profile and the sort of remarkable result.
Mark Schoenberg: So that's number one. And I think our experience with the mock panels, as Liz has pointed out, has been favorable precisely because of the encouraging safety profile and the sort of remarkable results of the Envision trial and the supportive data from Atlas and Optum. So I think Liz has articulated where we think. The conversation is going to go the importance of the you know, how to interpret the single-arm trial We have scoured the literature, and we've got all the supporting data you can possibly have for the single arm trial, the meaningfulness of ATLAS, the safety profile, and then the unmet medical need and how to articulate that.
Mark Schoenberg: <unk>.
Mark Schoenberg: The envision trial and the supportive data from Atlas and Optima, So I think I think <unk> articulated.
Mark Schoenberg: We see.
Speaker Change: The conversation is going to go the importance of.
Mark Schoenberg: How do we interpret the single arm trial.
Mark Schoenberg: We have done we've scoured the literature and we've got a we've got all the supporting data you can possibly have.
Mark Schoenberg: For the single arm trial, the meaningfulness of Atlas safety profile, and then the unmet medical need and how to articulate that.
Mark Schoenberg: And we believe those are going to be the areas of conversation, and as Liz pointed out, we have been preparing for months to answer those questions.
Mark Schoenberg: Believe those are going to be the areas of conversation as was pointed out we have been preparing for months to answer those questions.
Mark Schoenberg: You know, one thing I'll just add as well is we have two very strong KOLs that are joining us. They're part of our presentation. They'll be giving a presentation and they'll be also answering some of the questions. They have a lot of credibility. They're well known. Again, a lot of credibility. So when questions do get asked, and they are the ones who are standing up answering it, it's very helpful for us. And so I'm really, really pleased with the two KOLs that are joining us for our presentation during the ODAC.
Mark Schoenberg: One thing I'll, just add as well as we have two very strong kols that are joining us theyre part of our presentation there'll be giving a presentation and there'll be also answering some of the questions. They have a lot of credibility there well again a lot of credibility. So when the question is do get asked.
Mark Schoenberg: And they are the ones who are standing up answering it.
Mark Schoenberg: Helpful for us and so I'm really really pleased with the with the two kols that are joining us for our <unk>.
Mark Schoenberg: Presentation during the <unk>.
Kelsey Goodwin: Great, thank you so much for all the color and we're looking forward to watching it.
Mark Schoenberg: Great. Thank you so much for all the color and we're looking forward to watching it good luck. Thanks.
Liz Barrett: Good luck. Yeah, thanks. Thanks, Kelsey.
Speaker Change: Thanks Kelsey.
Operator: Please stand by for our next question.
Speaker Change: Please standby for our next question.
Leland Gershell: Our next question comes from the line of Leland Gershell with Oppenheimer. Your line is open. Hey, good morning. Thanks for taking my questions, two from us. First, I just want to ask, you know, in the FDA review process, we are about a month away from the PDUFA date. Just wondering, you know, given the adcom is still pending, just wanted to ask if you could share any color on your recent directions. Presumably you've had your late cycle meeting. Have you had the chance to discuss proposed labeling? Just wanted to ask if you're able to share any details there.
Speaker Change: Our next question comes from the line of Leland <unk> with Oppenheimer. Your line is open.
Speaker Change: Hey, good morning, Thanks for taking my questions two from us.
Speaker Change: First just wanted to ask in the FDA review process and we are about a month away from.
Speaker Change: The <unk> date, just wondering given given the add Tom is still pending just wanted to ask if you could share any color on your on your recent directions.
Speaker Change: You just had your late cycle meeting have you had the chance to discuss proposed labeling.
Speaker Change: I just wanted to ask Mr. <unk> to share any details there and then the second question I guess for Mark or David.
Liz Barrett: And then the second question, I guess, for Mark or David, you know, when I choose position to become, as you say, a foundational therapy and low grade intermediate risk at the same time, you know, urologist adoption may begin with a certain type of patient profile. Just wondering what you see as kind of that, you know, that most likely patient profile for urologists to start using 102, you know, out of the 60,000 patients, but what fraction might that be? Sure.
Speaker Change: Why not choose positioned to become as you say a foundational therapy in low grade intermediate risk at the same time.
Speaker Change: Urologist adoption may begin with a certain type of patient profile just wondering what you see.
Speaker Change: As kind of that debt.
Speaker Change: That most likely a patient profile for urologists to start using one or two.
Speaker Change: Out of the 60000.
Speaker Change: Patients with what fraction Mike Thank you sure.
Liz Barrett: So thanks, Leland, for the question. You know, I would say we feel really good about kind of where we are with the FDA. We've had continuous interactions with them, you know, all, you know, them asking questions. That's right. You can tell from where we are and the questions that they are asking where they are in the review. And so we have no concerns about the PDUFA date. And, you know, we don't want to get into a very specific conversation about our conversations with the FDA, but suffice it to say that it's very clear that, you know, they're at the end of their review, right?
Speaker Change: Thanks Leland for the question I.
I would say we felt really good about kind of where we are with the FDA, we've had continuous interactions with them.
Speaker Change: Yes, Im asking questions. That's great you can tell from where we are in the questions that they are asking where they are in the review and so we have no concerns about the <unk> date.
Speaker Change: And we don't want to get into very specific conversation about our conversations with the FDA, but suffice it to say that it's very clear that they are at the end of their review and we are in a position and it will be in a really good position post Ode act for that to move very quickly so again.
Liz Barrett: And we are in a position, and we'll be in a really good position post-ODAC for that to move very quickly. So again, you know, no concerns there. I think that, you know, as far as I think the conversation we had, the mid-cycle review around the label and switching it to the recurrent patient population has really made things, really simplified things, both from our presentation as well as any of the labeling or discussions with the FDA. And so I think that has helped a tremendous amount.
Speaker Change: No no concerns there I think as far as I think that conversation we had the mid cycle review around the label and switching it to the recurrent patient population has really made thing really simplify things both from our presentation as well as any of the labeling our discussions with the FDA and so I think that has helped.
Liz Barrett: We did not have a late-cycle meeting, and we're not going to have a late-cycle meeting. So when we met with them, I don't know if you recall, the mid-cycle review meeting was really later than it was supposed to be. There hasn't been a need for a late-cycle meeting, and they informed us at that time that there would not be a late-cycle review.
Speaker Change: A tremendous amount we did not have a late late cycle meeting and we're not going to have a late cycle meeting. So when we met with them I don't know if you recall the mid cycle review meeting was really late later than it was supposed to be there hasnt been a need for a late cycle meeting and they informed us at that time that there would not be at late cycle review, So we won't have that.
David Lin: So we don't have that. I'm going to ask David to talk to you about the populations in which we expect will be the kind of Low-Hanging Fruit, and the first patient that physicians will use this on. So, David. Yeah. Thanks, Liz. And thanks, Leland, for the question. Coming out of the gates, first I'll just share, we've done extensive market research with physicians, and suffice it to say, they are really pleased with the clinical data we've shared on UGN 102. They find it very compelling, and they see a need for it in their practices because of the multiple recurrences that their patients experience.
David: I'm going to ask David to talk to you about the populations in which.
David: We expect will be the kind of.
David: The low hanging fruit in the first patients that physicians will use his answer David yes, thanks, Louis and thanks Leland for the question.
Speaker Change: Coming out of the gate first I'll just share we've done extensive market research with physicians and suffice it to say there. They are really pleased with the clinical data we've shared on <unk> 102, they find it very compelling and they see a need for it in their practices because of the multiple recurrences that their patients experience.
David Lin: Coming out of the gates, there's really three segments that we've teased out in talking to physicians. First, it's those patients who have multiple recurrences. As you know, 70% of the patients have multiple recurrences. The second group are patients who are early recurrers. And then finally, there's a small set of patients that are just not able to have surgery for one reason or the other. It could be because of polypharmacy or they can't handle anesthesia, but those are the primary patient populations that we think are very, very ripe for uptake when we launch UGN 102. Importantly, though, one of the things around UGN 102 is that it fits into the workflow of the urologist office.
Speaker Change: Coming out of the gates Theres really three segments that we've teased out and talking to physicians first if those patients who have multiple recurrences as you know 70% of the patients have multiple recurrences.
Speaker Change: The second group are patients who are early recurs.
Speaker Change: And then finally, there is a small set of patients that are just not able to have surgery for one reason or the other it could be because of polypharmacy or they can't handle anesthesia, but those are the primary patient populations that we think are very very ripe for uptake when we launched <unk> 102, importantly, though one of the.
Speaker Change: Things around Eugene wanted to is that it fits into the workflow of the urologist office. So we're very pleased that with minimal training, we can help onboard UGI, one or two into practice and make it seamless experience I appreciate the question.
David Lin: So we're very pleased that with minimal training, we can help onboard UGN 102 into practice and make it a seamless experience.
David Lin: Appreciate the question.
Speaker Change: Alright. Thanks.
Operator: Thank you. Please stand by for our next question.
Speaker Change: Thank you.
Speaker Change: Please standby for our next question.
Raghuram Selvaraju: Our next question comes from the line of Raghuram Selvaraju with HC Wainwright. Your line is open. Thanks so much for taking my questions. Just, you know, in furtherance of, you know, what has already been asked on this call regarding the ODAC. I was wondering if you could comment on two aspects in particular. Firstly, to what extent there has been communication regarding the purpose of the ODAC that pertains specifically to the lack of specific precedent for products being approved in low-grade, intermediate-risk NMI-BC. If you expect that to be a meaningful topic of discussion at the ODAC meeting with regard to UGN-102.
Speaker Change: Our next question comes from the line of Rick who ran several Roger with H C. Wainwright. Your line is open.
Rick: Thanks, so much for taking my questions just on further and so.
Rick: What has already been asked on this call regarding the <unk> I was wondering if you could comment on two aspects in particular firstly.
Rick: To what extent.
Rick: There has been communication regarding the purpose of the <unk> that pertains specifically to the lack of specific precedent for products being approved in low grade intermediate risk and there might be if you expect that to be.
Rick: A meaningful topic of discussion at the <unk> meeting with regard to you Jan one or two and then secondly to what extent you expect the precedent case of gel Mito to aid and facilitate the discussion around <unk> 102 to effectively put the committee.
Mark Schoenberg: And then secondly, to what extent you expect the precedent case of gelmido to aid and facilitate the discussion around UGN-102 to effectively put the committee in a position to be familiar with how UGN-102 works, what its benefit level is, and effectively facilitate potentially direction towards a favorable panel vote because of this precedent example that utilizes the same active ingredient and the same fundamental principle of delivery. Great, great points, Ram, and Mark, why don't you comment and then I'll add some color as well. Yeah, sure. Thanks for the insightful comments. With respect to the first question, I think it's implicit in your observation that this is a...
Rick: In a position to be familiar with our <unk> 102 works what gets benefit level is and effectively.
Rick: Facilitate potentially direction towards the favorable panel vote.
Rick: Cause of this precedent example that utilizes the same active ingredient and took the same fundamental principle of delivery. Thank you.
Speaker Change: Great Great points, Rob and Mark why don't you comment and then I'll add some color as well, yes sure. Thanks for the insightful comments.
Rick: The.
Rick: With respect to the first question I think it's implicit in your observation that this is <unk>.
Rick: Therapy that were presented to the agency.
Rick: FDA with like a public conversation about what the meaningfulness of this approach to this disease would be.
Mark Schoenberg: I thank you all for joining us. with an option that does not involve surgery, we think a robust discussion about that is going to take place within the context of what Liz was referring to earlier, namely the... clinical clinician trial. That said, we believe we have ample data to support the meaningfulness of the clinical outcome we've observed in our trials, as well as the benefit to patients of having an option. It is interesting to remember that this would be the only urologic cancer, to my knowledge, where patients really don't have a choice of therapies. They only have one therapy.
Rick: In the setting of an expert panel. So we've always thought that that was part of the reason for the <unk> that the FDA has promised us for a very long time would be the case in the approval process for UGI and one or two.
Rick: It is a different way of treating patients because it is a primary therapy because it does.
Rick: With an option that does not involve surgery, we think a robust discussion about that it's going to take place within the context of what <unk> was referring to earlier, namely the move.
Rick: The implementation trial that said, we believe we have ample data to support.
Speaker Change: The meaningfulness of the clinical outcome, we've observed in our trials as well as the benefit to patients who are having an option. It is interesting to remember that this would be the only urologic cancer to my knowledge, where patients really don't have a choice of therapies. They only have one therapy. So eugene.
Mark Schoenberg: So UGN 102 would present this population with the type of option that many patients with urologic cancers have in other settings, whether they be prostate or kidney cancer, or more advanced forms of bladder cancer. So we think we can address that, and we think that is going to be a part of the conversation overall.
Speaker Change: Present at this population with the type of option that many patients with Urologic cancers had in other settings, whether they be prostate or kidney cancer, where more advanced forms of bladder cancer. So we think we can address that and we think that is going to be a part of the conversation to overall.
Mark Schoenberg: And then, sorry, the second question is It was around the precedent case of gelmido. Oh, I'm sorry. Yes. And we and so we actually do as part of our presentation, we actually remind or acquaint the committee with, with gelmido and its history and the fact that as informative with respect to thinking about upper tract disease. So we have, in fact, put forward a segment of our presentation to specifically familiarize the advisory committee with gelmido and its history and the similarities with respect to approach and active ingredient to reassure them that this is, in fact, the follow on conceptually to what we've already had approved by the FDA.
And then.
Speaker Change: Sorry, the second question is.
Speaker Change: It was around the precedent case John might have.
Speaker Change: Sorry, yes.
Speaker Change: And so we actually do as part of our presentation, we actually remind were acquainted.
Speaker Change: Committee with.
Speaker Change: <unk> in its history and the fact that her.
Speaker Change: As informative with respect to thinking about our protract disease. So we have in fact.
Speaker Change: Put forward a segment of our presentation to specifically familiarize the advisory committee with gel Mito and its history and the similarities with respect to approach an active ingredient.
Speaker Change: To reassure them that this is in fact, a follow on conceptually to what we've already had approved by the FDA, but listen I want to comment as well.
Liz Barrett: But Liz may want to comment. Yeah, no, I think that's great. I think the only other comment I'll make is one of the reasons we want to do that is because the ODAC panel will be made up mostly of medical oncologists, right? So they will have ad hoc members, urologists. But because medical oncologists are not familiar with either this disease or our treatments, we felt like it was important. And, you know, Mark put that into the presentation. So, but but great, great, great questions, because those are exactly why we're actually going to the ODAC and exactly the right questions to ask.
Speaker Change: Yes, no I think thats, great I think the only other comment I'll make is one of the reasons. We wanted to do that is because the <unk> panel will be made up mostly of medical oncologists right. So they will have AD hoc members urologists.
Speaker Change: But because of medical oncologists are not familiar with.
Speaker Change: Either this disease or treatment, we felt like it was important.
Speaker Change: Mark put that into the presentation, so but great great great questions. Because those are exactly why we are actually going to the <unk> in exactly the right questions.
Liz Barrett: So thank you all.
Rob: So thank you Rob.
Raghuram Selvaraju: Just one quick follow-up, if I may. Can you give us an update on the current status of the UGN 103 Clinical Development Program, and when you expect to report the next material update on the progress of that trial? Yeah, we're almost fully enrolled. And so we'll be able to share that soon.
Speaker Change: Just one quick follow up if I may can you give us an update on the current status of the Eugene 100, III clinical development program and when do you expect to report the next material updates on the progress of that trial. Thank you.
Rob: Yeah.
Rob: It's fully enrolled and so we'll be able to share that soon so as soon as over the next couple of months as soon as were finished enrollment will be able to provide the fact that we.
Mark Schoenberg: So as soon as over the next couple of months, as soon as we're finished enrollment, we'll be able to provide the fact that we've finished enrollment will be by the end of the summer. And then we'll go from there as far as the timing for the CR, you know, all patients at CR and then all patients, you know, and durability. So that those would be the next steps, you'll start to see data in 26.
Rob: Finish enrollment.
Rob: We will be by the end of the summer and then we'll go from there as far as the timing for the CR.
Rob: All patients in CR, and then all patients and durability. So that those would be the next steps you'll start to see data in 2006.
Alana Paul Choi: Thank you. Will you stand by for our next question? Our next question comes from Alana Paul Choi with Goldman Sachs, your line is open. Hi, thank you and good morning everyone. I had a question about how maybe you're thinking about the market for 102 here. David provided some nice color on the population size and opportunity as well as expected greater patient population in the community setting. But I was just curious, given the trend you're seeing with 340B utilization for gelmido, is that something structural you also expect for the 102 market? Just some color there would be helpful in just thinking about hospital pharmacy pricing.
Rob: Thank you.
Please standby for our next question.
Speaker Change: Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is open.
Paul Choi: Hi, Thank you and good morning, everyone.
Paul Choi: Had a question about how maybe you're thinking about the market for one or two here David provided some nice color on the population size and opportunity as well.
Paul Choi: <unk>.
Paul Choi: Greater patient population in the community setting, but I was just curious given the trends youre seeing with 340 B utilization for <unk> is that something structural you also expect for the 100 to market just some color there would be helpful. On just thinking about.
Liz Barrett: And then my second question is for Mark, just in terms of your earlier comments on thinking about advancing 301, sort of maybe can you provide us how you're thinking about maybe the bar for the go or no-go decision for that program for the CTLA-4? Thank you very much. Yeah, the good news for UGM 102 is the 340B, we expect the discounts not to be as great as they are for gelmido because to your point, we do expect that ultimately, not at the beginning, but ultimately that it will be a sort of 70% of the business will be in the community based off of the comments that David made around that.
Paul Choi: Hospital pharmacy pricing.
Paul Choi: My second question is for Mark just in terms of your earlier comments on thinking about advancing 301 sort of maybe can you provide us how youre thinking about maybe the bar for the go or no go decision for that program for the <unk>. Thank you very much.
Paul Choi: Yes, the good news for <unk> 102 is the 340 B, we expect not the discounts not to be as great. As they are for John Mito because to your point, we do expect that ultimately not at the beginning but ultimately it will be at sort of 70% of the business will be in the community based offers.
Speaker Change: The comments that David made around that so so we are really hopeful and expect spectrum that the three or four it will be will be much less and Eugene one or two.
Liz Barrett: So we are really hopeful and expecting that the 340B will be much less in UGM 102 than it is for, but we have been more conservative with our assumptions also as we go into UGM 102, because as you know, gelmido, that's been one of the headwinds we've shared because our data, our actual patient demand has been much greater, but we've seen some real challenges with the 340B.
Speaker Change: Then it is far but we have been more conservative with our assumptions also as we go into <unk> because as you know John Mitre Thats been one of the headwinds we've shared because our data our actual patient demand has been much greater but we've seen some some real challenges for the $3 40.
Mark Schoenberg: Mark, do you want to talk about, Paul's second question? Sure. Thanks, Paul. So, as the audience will undoubtedly remember, 301 is our Intravesical Immunotherapy Approach to High-Grade Disease, and it's a Phase I study, both, as Liz said earlier, a monotherapy study, and in combination with our TLR7 agonist, DGN 201, as well as with the germ cytosine. So, as a Phase I study, it's primarily focused on tolerability and safety and not on efficacy. That said, we have said publicly that we've seen a few responses, and we are very interested in these responses for obvious reasons. But in a Phase I study, it would be a little bit difficult to give you a numeric bar that we are expecting to be meaningful.
Mark Schoenberg: Mark do you want to talk about.
Paul Choi: Paul The second question sure.
Speaker Change: Sure.
Speaker Change: Thanks, Paul.
Speaker Change: No.
Speaker Change: The audience will undoubtedly remember 301 is our.
Speaker Change: Intra vesicle immunotherapy approach to high grade disease, and it's a phase one study you. Both as was said earlier a monotherapy study in combination with our Telos seven agonist <unk> 201, as wallet share as well as with Gemcitabine.
Speaker Change: So as a phase one study is primarily focused on tolerability and safety and not an efficacy that said we have said publicly that we have seen a few responses and.
Speaker Change: We are very interested in these responses for obvious reasons.
Speaker Change: But in a phase one study it would be a little bit difficult to give you a numeric bar that we're expecting to be meaningful with what we're doing now is following patients to look for the durability of these responses and later this year.
Mark Schoenberg: What we are doing now is following patients to look for the durability of these responses. And later this year, we anticipate presenting those data, probably at the SUO at the end of the year, at which time we'll have had a chance to assess both the durability and quality of those responses in the combination arms. And at that point, we'll probably be in a go-no-go decision about a trial that would be able to answer the question that you're asking, namely what numeric bar would be meaningful for us in comparison to the other assets out there currently addressing this population.
Speaker Change: Presenting those data probably at the suo at the end of the year at which time, we will have a chance to assess both the durability.
Speaker Change: <unk> and quality of those are responses in the combination arms and.
Speaker Change: At that point, we will probably be in a position to make a go no go decision about a trial that would be able to answer the question that youre, asking, namely what numeric bar would be meaningful for us in comparison to the other assets out there currently addressing this population. So I guess my my short answer is it's probably premature for me to give you a number but we are encouraged.
Mark Schoenberg: So, I guess my short answer is it's probably premature for me to give you a number, but we are encouraged that we're seeing responses, we're tracking those, and we'll be able to talk later this year about what would constitute a signal to us for go-no-go for Phase 2.
Speaker Change: We're seeing responses, we're tracking those and we'll be able to talk later this year about what what would constitute a signal to us for go no go for phase two and this may want to comment as well.
Liz Barrett: And Liz may want to comment as well. Yeah, my, my comments are really around, it's very clear that the bar for efficacy and safety, but particularly for efficacy is definitely higher than it was when we started the program, given the results, you know, that you've seen, I do think there's still a lot of opportunity in high grade disease for several reasons. One, these patients are not cured, unfortunately, so they continue to see recurrences, and so they need more treatments because it's not, these aren't cures. Two, I think all of the current programs that are out there that are seeing the higher complete response rates and durability are because you're seeing continuous dosing.
Speaker Change: Yes.
Speaker Change: My comments are really around it's very clear that the bar.
Speaker Change: <unk> efficacy and safety, but particularly for efficacy is definitely higher than it was when we started the program given the results that you've seen I do think there is still a lot of opportunity and high grade disease for several reasons. One these patients are not short unfortunately.
Speaker Change: So they continue to see recurrences and so they need more treatment because it's not these aren't yours too I think all of the current programs that are out there that are seeing the higher complete response rates and durability are because youre seeing continuous dosing so almost all of them.
Liz Barrett: So almost all of them are requiring re-inductions, continuous dosing, and so I still think that there's opportunity if you can have a situation like we have with UGN 102 and intermediate risk, where actually we're given six weeks and then the patients don't have treatment. And I think that's very important for patients to not only be recurrence-free, but also treatment-free. And so being able to have a more simple administration and administration schedule, although I do believe that in high grade you're more likely to need to have some sort of maintenance or retreatment, I do think that there's still a lot of opportunity, but we will be very diligent and we'll be very critical before we launch into a very expensive phase two or phase three study with UGN 301.
Speaker Change: Our requiring re inductions continuous dosing and so I still think that there is opportunity. If you can have a situation like we have with <unk> 102 in intermediate risk. We're actually we're given six weeks and then the patients don't have treatment and I think that's very important.
Speaker Change: For patients cannot only be recurrence free but also treatment free.
Speaker Change: So being able to have more simple administration and administration schedule, Although I do believe in high grade youre more likely to need to have some sort of maintenance or re treatment.
Speaker Change: Do think that there's still a lot of opportunity, but we will be very diligent and we will be very critical before we launch into a very expensive phase II or phase III study with <unk> hundred one and also I just wanted to mentioned fiber one right. We're very excited about that so we will have to make a determination.
Liz Barrett: And also I just want to mention 501, right? We're very excited about that. So we will have to make a determination for 301 and 501 about where we move and when we move and how we move. And so those are all things that we're working on right now. And so, as Mark said, a little too early to comment, except to understand that the bar is definitely higher. And we believe that both of those approaches actually can easily reach that bar and potentially simplify the administration. Great.
Speaker Change: For 301, and 501 about where we move and when we move and how we move and so those are all things that we're working on right now.
Speaker Change: And so as.
Speaker Change: As Mark said, a lot too early to comment except to understand that the bar is definitely higher and we believe that both of those approaches actually can can easily reach that bar and potentially.
Speaker Change: Potentially simplify the administration.
Alana Paul Choi: Thank you for the caller. Thank you. Thanks, Paul.
Great. Thank you for the color.
Paul Choi: Thank you thanks Paul.
Operator: Please stand by for our next question.
Speaker Change: Please standby for our next question.
George Farmer: Our next question comes from the line of George Farmer with Scotiabank. Your line is open. Hi, good morning. Thanks for taking my questions. A few from me. Can you confirm that the FDA representatives you've been speaking with are still employed with the agency? That's number one. Number two, this 18-month data that you presented at AUA, is that going to be included during the discussion at ODAC? And number three, Do you see a need, or are you planning for any sort of direct-to-consumer advertising campaign? Thanks.
Speaker Change: Our next question comes from the line of George Farmer with Scotiabank. Your line is open.
George Farmer: Hi, good morning, Thanks for taking my questions a few for me.
George Farmer: Can you confirm that the FDA representatives, you've been speaking with are still employed with the agency that's number one.
George Farmer: Number two this 18 month data that you presented at <unk> is that going to be included.
George Farmer: Yes during the discussion at <unk> and number three.
Speaker Change: Do you see a need or are you planning for any sort of direct to consumer advertising campaign. Thanks, Yeah, great. Great question <unk>. Thank you very much the FDA team and knock on wood is still in place. The same team that had been there since Joe might owe frankly.
Liz Barrett: Yeah, look, great questions, Russ. Thank you very much. The FDA team at Knock Home Wood is still in place, the same team that have been there since Jelmido, frankly. So hopefully, over the next few weeks, that team stays in place. But they're still the same people that we've been working with all along, and we can confirm that they're still employed in there. The 18-month data has already been incorporated. The FDA received that before it was even public, so all that data is with the FDA, and has been, and is part of all of our discussions and presentation with them.
Speaker Change: So hopefully over the next few weeks that team stays in place, but there is still the same people that we've been working with a long and we are we can confirm that there are still employed and there. The 18 month data has already been incorporated the.
Speaker Change: The FDA received that before it was even public so that all of that data is with the FDA and has been and is part of all of our discussions and presentations with them and I'm, sorry, I forgot the last question direct to consumer direct to consumer.
Liz Barrett: And I'm sorry, I forgot the last question. Direct-to-consumer. Oh, direct-to-consumer.
Liz Barrett: Well, I wouldn't expect broad-based direct-to-consumer, but we will absolutely have programs that engage the patient. It's really important. I think you've heard several times, we talk about the fact that 90% of patients prefer UGM-102 to a TRBT. These are patients that have had a TRBT, and they've had UGM-102, and 90% of them prefer UGM-102. So we really need to ensure that we engage the patient, because we want that physician, we want them to be part of the discussion and part of the treatment decision. So when a physician gives them the option that they understand and know.
Speaker Change: I Wouldnt say I Wouldnt expect broad based direct to consumer, but we will absolutely have programs that engage the patient.
Speaker Change: Really important I think you've heard several times when we talk about the fact that 90% of patients prefer <unk>, one or two to <unk>. These are patients that have had at <unk> and they've had to EOG and wanted to and 90% of them prefer Eugene one or two so we really need to ensure that we engage the patient because.
Speaker Change: We want that position, we want them to be part of that discussion and part of the treatment decision. So we're in a position gives them the option that they had they understand and noticed that so we will again engage a patient but not expected initially to be in broad based DTC.
Liz Barrett: So we will, again, engage a patient, but not expect it initially to be in broad-based. Okay. Thanks, Liz. Thank you. Please stand by for our next question.
Speaker Change: Okay. Thanks Les.
Speaker Change: Thank you.
Speaker Change: Please standby for our next question.
Aydin Huseynov: Our next question comes from a line of Aydin Huseynov with Landenburg. Your line is open. Hi, good morning, everyone. Thank you for taking our questions. I got a couple.
Speaker Change: Our next question comes from the line of Iden housing up with Ladenburg. Your line is open.
Speaker Change: Hi, Good morning, everyone and thank you for taking our questions I got a couple.
Mark Schoenberg: Maybe this is a little bit unusual question, but curious what would happen to patients who progress on UGN 1 or 2 with 20 or 25 or whatever percentage. So would they switch back to TURP or would you re-dose them with UGN 1 or 2? Yeah, Mark, do you want to take that? Sure. So let me start out by saying that thankfully, very few patients did what's called progress during treatment. UGSR program and when we say progression what we're talking about is a patient with low-grade disease turning into someone with high-grade disease or even more unusually turning into someone with invasive disease.
Speaker Change: Maybe this is a little bit unusual question, but curious what would happen to patients who progress on <unk>, two the 20 or 25% or whatever.
Speaker Change: So wood based switch back to term or would you read those them with you Jim wanted to them.
Speaker Change: Yes, Mark do you want to take that sure.
Mark Schoenberg: So let me start out by saying that thankfully very few patients did what's called progress.
During treatment.
Speaker Change: Across <unk>, our program and when we say progression what we're talking about.
Speaker Change: Patients with low grade disease, turning into somewhere with high grade disease, or even more unusually turning into summer with invasive disease. So that eventuality that rarely occurred in our program that said impatient.
Mark Schoenberg: So that eventuality that rarely occurred in our program. That said, in patient who responded and then recurred or didn't respond completely after treatment with UGN-102, the use of transurethral resection to remove any residual or recurrent tumor was not associated with complications or problems that were exceptional or unusual. So standard of care currently, which is our experience in our clinical trials program, is that it's not complicated by prior use with treatment with the UGM-102.
Speaker Change: Two bonded and then recurred or didn't respond completely with after treatment in Eugene and one or two.
Speaker Change: <unk> resection to remove any residual or recurrent tumor was not associated with complications or problems that were exceptional or unusual.
Speaker Change: So we entered a care currently which is our experience of our clinical trials program is that it's not complicated by prior use with <unk>.
Speaker Change: Treatment with Eugene one or two as for what Youre anticipating which is.
Liz Barrett: As for what you're anticipating, which is, you know, if approved and patients are successfully treated initially with UGM-102, how would they subsequently be treated, assuming they had the same disease? I think I'm going to defer to Liz as to how she thinks that would happen. We don't currently have clinical trials data to tell us specifically about what retreatment would mean or look like. But, Liz, I don't know if you want to postulate what you think would happen once approved. Yeah, I mean, I think it's very similar to what you would see in other cancers. If a patient gets a good response and a durable response, and then they recur, physicians are likely to retreat with what they use the first time.
Speaker Change: If approved and patients were successfully treated initially with your GM one of.
Speaker Change: They subsequently be treated assuming they have the same disease, I think I'm going to defer to lose as to how she thinks that would happen. We don't currently have clinical trials data to tell us specifically about what re treatment would mean will look like but I don't know if you want to postulate, what you think would happen once approved.
Speaker Change: Yeah, I mean, I think it's very similar to what you would see and other cancers. If a patient gets a good response and durable response and then they recur physicians are likely to occur to retreat with what they use the first time and so we expect that to happen, we will absolutely either launch phase.
Liz Barrett: And so we expect that to happen.
Liz Barrett: We will absolutely either launch a phase four study, or have a registry or some way to generate data that shows what happens when patients recur and get treated. And then the other patient population that we'll want to study as well are partial responders. So, you know, we, I don't know if you remember, but when we did the announcement of the durability, one of the doctors talked about the fact that, you know, that they had one patient had so much tumor, and UTM-102 got 90% of the tumor, but they couldn't be considered a complete responder. So what would happen if you gave that patient a couple of additional, you know, treatments?
Speaker Change: <unk> study or have a registry or some way to generate data that shows what happens when patients recur and get retreated and then the other patient population that will want to study as well are partial responders. So.
Speaker Change: I don't know if you remember when we did the announcement of the durability one of the Doctor has talked about the fact that you know.
Speaker Change: One patient had so much tumor.
Speaker Change: And you'd see it in one or two got 90% of the tumor, but they couldnt be considered a complete responder. So what would happen. If you gave that patient a couple of additional.
Liz Barrett: Could you take these partial responders and put them into complete response? So we will be looking at all of those questions through either IRRs, phase four, registry, but we will have a way to generate data that will support the use of UTM-102 once a patient has recurred either on our drug or, you know, after a TRBT.
Speaker Change: Treatments could you take these partial responders and put them into complete response, so we will be looking at all of those questions through.
Speaker Change: Through either IRR space for registry, but we will have a way to generate data that will support the use of <unk> to once a patient has recurred either own our drug or after a T. RPT. So very much expect that you would be able to retreat very much like you do like I said in other cancers.
Aydin Huseynov: So very much expect that you would be able to retreat very much like you do, like I said, in other Thank you. I appreciate that.
Speaker Change: Thank you I appreciate that and then another question Thats commercial question.
Chris Degnan: And another question is a commercial question. Could you clarify the GTN gross net for Jomido and what should be the expectation of GTN for UGN-102? Yep, Chris. So, Aydin, we've been, you know, kind of in the mid-70s percent net of growth for gel mito and, you know, the one thing we said on the call is we do expect At the headwinds we've been experiencing for 340B, you know, some of those headwinds have started to annualize a bit. So from a year-over-year growth perspective, as we think about the rest of this year, we would expect that impact to be less impactful in terms of our growth rate.
Speaker Change: Could you clarify the GTA gross to net for <unk> and what should be the expectation of GTS for UGI and one or two.
Speaker Change: Yes, Chris.
Speaker Change: So we've been.
Speaker Change: Kind of in the mid 70%.
Speaker Change: Percent net of gross for Joe <unk>.
Speaker Change: And what we said on the call is we do expect.
Speaker Change: But the headwinds we've been experiencing for 340 B. Some of these headwinds are sort of annualize a bit so from a year over year growth perspective, as we think about the rest of this year, we would expect that impact to be less impactful in terms of our growth rate.
Chris Degnan: In terms of UGN 102, as Liz mentioned, over time, we do expect the growth to net profile to be more favorable for UGN 102 as compared to gelmito, namely because mix of business to be more heavily weighted towards community.
Speaker Change: In terms of Eugene and one or two as Liz mentioned over time, we do expect the gross to net profile to be more favorable for you Jan one or two as compared to Joe might owe, namely because mix of business to be more heavily weighted towards community.
Aydin Huseynov: Initially at launch, we do expect more utilization in the hospital setting, but over time that should shift over time. Okay, thanks so much for taking questions. Thank you.
Speaker Change: Initially at launch we do expect more utilization in the hospital setting, but over time that that should shift over to the community.
Speaker Change: Okay. Thanks, so much for taking the question.
Speaker Change: Thank you.
Operator: Ladies and gentlemen, I'm showing no further questions in the queue.
Speaker Change: Ladies and gentlemen, I'm showing no further questions in the queue I would now like to turn the call back to Lee for closing remarks.
Liz Barrett: I would now like to turn the call back to Liz for closing remarks. Well, thanks, everybody. As you can imagine, a lot of excitement over here as we prepare and get ready for the ODAC next week. We appreciate all of your support. It's been a long time coming. We're excited about it, though. We feel really good about it. And, you know, most importantly, these patients need new options. And so we're very much looking forward to next week and then following that, the PDUFA. So thanks, and we'll keep you guys informed of any happening. So thanks a lot.
Lee: Thanks to everybody as you can imagine a lot of it.
Lee: <unk> over here as we prepare and get ready for the <unk> next week. We appreciate all of your support it's been long a long time coming and we're excited about it though we feel really good about it and most importantly, these patients need new options and.
Lee: And so we're very much looking forward to next week and then following that the producers. So thanks, and we'll keep you guys informed of any of any any happening. So thanks, a lot we'll talk to you guys. Soon bye bye.
Operator: We'll talk to you guys soon. Bye-bye.
Operator: Ladies and gentlemen that concludes today's conference call. Thank you for your participation.
Speaker Change: Ladies and gentlemen that concludes today's conference call. Thank you for your participation you may now disconnect.
You may now disconnect.