Urogen Pharma Ltd (URGN) 2025 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the UroGen Pharma second-quarter 2025 earnings call. (Operator Instructions) Please be advised that today's conference is being recorded.

您好，感謝您的支持。歡迎參加 UroGen Pharma 2025 年第二季財報電話會議。（操作員指示）請注意，今天的會議正在錄音。

I'd now like to go ahead and hand the conference over to your first speaker today, Vincent Perrone, Investor Relations. Vincent, you have the floor.

現在，我想將會議交給今天的第一位發言人，投資者關係部的 Vincent Perrone。文森特，請你發言。

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's second-quarter 2025 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended June 30, 2025. The press release can be accessed on the Investors portion of our website at investors.urogen.com.

謝謝您，接線生。大家早安，歡迎參加 UroGen Pharma 2025 年第二季財務業績和業務更新電話會議。今天早些時候，我們發布了一份新聞稿，概述了我們最近的公司亮點和截至 2025 年 6 月 30 日的季度財務業績。您可在我們網站的投資者部分（網址為 investors.urogen.com）上查閱該新聞稿。

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.

今天與我一起參加電話會議的還有總裁兼執行長 Liz Barrett、首席醫療官 Mark Schoenberg 博士、商務長 David Lin 和財務長 Chris Degnan。

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

在今天的電話會議中，我們將做出一些前瞻性的陳述。這些可能包括有關我們正在進行的與 JELMYTO 和 ZUSDURI 相關的商業化活動、我們正在進行和計劃中的臨床試驗、商業和臨床里程碑、市場和收入機會、我們的商業化策略和預期以及預期數據、監管備案和決定、ZUSDURI 是 UroGen 的主要增長動力、我們的產品和產品候選物的潛在利益、未來的研發發展

These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements.

這些前瞻性陳述基於當前資訊、假設和預期，可能會發生變化。在我們的收益新聞稿和最新的 SEC 揭露文件中找到潛在風險的描述。請注意不要過度依賴這些前瞻性陳述，UroGen 不承擔更新這些陳述的任何義務。

I'll now turn the call over to Liz.

我現在將電話轉給 Liz。

Thank you, Vincent. On June 12, we achieved a defining milestone for UroGen with the FDA approval of ZUSDURI for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. This was truly a landmark moment for our company and importantly, for the 59,000 annual patients in the US who face recurrent and repeat surgeries year after year with no approved alternatives.

謝謝你，文森。6 月 12 日，FDA 批准 ZUSDURI 用於治療復發性低度中度風險非肌肉浸潤性膀胱癌的成年人，這對 UroGen 來說是一個決定性的里程碑。這對我們公司來說確實是一個里程碑時刻，更重要的是，對於美國每年 59,000 名面臨反覆手術且沒有獲批替代方案的患者來說，這是一個里程碑時刻。

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

ZUSDURI 是 FDA 批准的首個也是唯一一個針對患有這種疾病的成年人的藥物治療，有可能從根本上改變治療模式，為患者提供持久的長期復發和無需治療的生活。

We are proud to be leading that shift. ZUSDURI is UroGen's second commercial product and marks our transition from a rare disease-focused company to a scaled multiproduct organization. Five years ago, we launched JELMYTO for the treatment of low-grade upper tract urothelial cancer. That experience laid the foundation for everything we're doing today. With ZUSDURI, we are entering a larger but less complex market.

我們很自豪能夠引領這項轉變。ZUSDURI 是 UroGen 的第二個商業產品，標誌著我們從一家專注於罕見疾病的公司轉型為規模化的多產品組織。五年前，我們推出了 JELMYTO，用於治療低度上泌尿道尿路上皮癌。那段經歷為我們今天所做的一切奠定了基礎。借助 ZUSDURI，我們正在進入一個更大但更簡單的市場。

The total available market exceeds $5 billion annually, and we are well positioned to penetrate the opportunity with our expanded sales team of 82 territories as of August 1, up from 50 previously. We have an experienced team with strong knowledge and relationships that will allow us to accelerate and guide the launch of ZUSDURI.

每年總可用市場超過 50 億美元，截至 8 月 1 日，我們的銷售團隊已從之前的 50 個地區擴展到 82 個地區，我們已準備好抓住這一機會。我們擁有一支經驗豐富的團隊，他們擁有豐富的知識和人脈，這將使我們能夠加速並指導 ZUSDURI 的推出。

Our commercial organization has a deep understanding of how care is delivered in neurology from academic centers to high-volume community practices. Their established relationships and field insights position us well for a strong and disciplined launch. Regarding the commercial launch of ZUSDURI, the initial focus is on setting up sites of care and driving clinical conviction.

我們的商業組織對從學術中心到大批量社區實踐的神經病學護理方式有著深刻的理解。他們建立的關係和領域洞察力為我們強大和有紀律的發布奠定了基礎。關於 ZUSDURI 的商業化推出，最初的重點是建立護理站點和推動臨床信念。

The team is focused on driving early adoption among urologists who previously prescribed JELMYTO and those willing to initiate treatment before a permanent J-Code is assigned. This is a disciplined strategic launch built on learnings from our first product. As we move to 2026 with broader reimbursement anticipated, we expect our reach to expand significantly. David will provide more details on the launch in a few minutes.

該團隊致力於推動先前開過 JELMYTO 處方的泌尿科醫生以及願意在分配永久 J-Code 之前開始治療的泌尿科醫生儘早採用該藥物。這是基於我們第一款產品經驗教訓的嚴謹的策略發布。隨著我們進入 2026 年，預計報銷範圍將更加廣泛，我們預計我們的覆蓋範圍將大幅擴大。幾分鐘後，David 將會提供有關此發布的更多細節。

Turning to JELMYTO. I'm pleased to report a strong second quarter with net product revenues of $24.2 million, representing an 11% increase over the same period in 2024. JELMYTO continues to grow with strong underlying demand in the second quarter, demonstrating continued adoption and usage of this important therapy for patients.

轉向 JELMYTO。我很高興地報告第二季表現強勁，淨產品收入為 2,420 萬美元，比 2024 年同期成長 11%。JELMYTO 在第二季度持續成長，潛在需求強勁，顯示患者繼續採用和使用這種重要的治療方法。

The value proposition of JELMYTO remains clear: durable responses backed by long-term data and real-world use. We are pleased with the results and acceptance received by urologists. UroGen's long-term goal is to develop and commercialize a differentiated portfolio of treatments that address meaningful unmet needs across urothelial and specialty cancers.

JELMYTO 的價值主張仍然明確：以長期數據和實際使用為後盾的持久響應。我們對泌尿科醫師的結果和接受度感到滿意。UroGen 的長期目標是開發和商業化差異化的治療組合，以滿足尿路上皮癌症和特種癌症領域未滿足的重大需求。

UGN-301, our anti-CTLA-4 monoclonal antibody, continues to progress in both monotherapy and combination studies for high-grade non-muscle invasive bladder cancer. Meanwhile, our next-generation pipeline is advancing. The Phase 3 UTOPIA trial of UGN-103 for recurrent low-grade intermediate risk non-muscle invasive bladder cancer is now fully enrolled, and we expect initial complete response data by the end of 2025.

我們的抗 CTLA-4 單株抗體 UGN-301 在高級別非肌肉浸潤性膀胱癌的單一療法和聯合研究中持續取得進展。與此同時，我們的下一代管道正在推進。UGN-103 針對復發性低度中度風險非肌肉層浸潤性膀胱癌的 3 期 UTOPIA 試驗現已全面入組，我們預計到 2025 年底將獲得初步完全緩解數據。

We will share this data with the FDA and gain agreement on the path forward to approval. If the trial is successful, we expect to file an NDA for this product in 2026. We've also initiated a Phase 3 trial in June of 2025 for UGN-104, our next-generation mitomycin-based formulation for low-grade UTUC.

我們將與 FDA 分享這些數據並就批准的途徑達成一致。如果試驗成功，我們預計將於 2026 年為該產品提交 NDA。我們也將於 2025 年 6 月啟動 UGN-104 的 3 期試驗，這是我們針對低度 UTUC 的下一代絲裂黴素配方。

Our balance sheet remains strong with $161.6 million in cash, cash equivalents and marketable securities as of June 30. We believe we have the necessary capital to fund the ZUSDURI launch while supporting the advancement of our pipeline and other strategic priorities. We will be thoughtful about potential opportunities to expand our portfolio for the long term while driving commercial success and profitability goals.

我們的資產負債表依然強勁，截至 6 月 30 日，現金、現金等價物和有價證券為 1.616 億美元。我們相信，我們擁有資助 ZUSDURI 發射所需的資金，同時支持我們管道和其他戰略重點的推進。我們將認真考慮長期擴大投資組合的潛在機會，同時推動商業成功和獲利目標。

The team at UroGen has demonstrated their dedication and resilience while striving to make a meaningful impact for patients. To the urology community, particularly those participating in research as well as those publicly advocating support for our medicines, we could not do it without you. With two commercial products and advancing pipeline and the commercial infrastructure to scale, UroGen is well positioned for sustainable growth. We are executing with discipline and purpose, and we remain deeply committed to delivering meaningful innovation for patients and generating value for our shareholders.

UroGen 團隊在努力為患者帶來有意義的影響的同時，也展現了他們的奉獻精神和韌性。對於泌尿科界的同仁們，特別是那些參與研究以及公開支持我們藥物的同仁們，如果沒有你們，我們就無法做到這一點。憑藉兩種商業產品和不斷推進的管道以及可擴展的商業基礎設施，UroGen 已做好實現永續成長的準備。我們嚴格遵守紀律、有目的地執行任務，並始終堅定地致力於為患者提供有意義的創新並為股東創造價值。

I will now turn the call over to Mark Schoenberg. Mark?

現在我將電話轉給馬克·勳伯格。標記？

Thank you, Liz. As a practicing urologist, I've spent years managing patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. We see the approval of ZUSDURI as a meaningful advancement in how we care for this population. And for the first time, we can offer patients and their healthcare providers an effective pharmacologic treatment that targets the underlying disease and offers a convenient office-based outpatient alternative to repeated surgeries. We view this as a significant shift in the standard of care.

謝謝你，莉茲。身為一名執業泌尿科醫生，我多年來一直致力於治療復發性低度中度風險非肌肉層浸潤性膀胱癌患者。我們認為 ZUSDURI 的批准是我們照顧這群人的有意義的進步。並且，我們首次能夠為患者及其醫療保健提供者提供針對潛在疾病的有效藥物治療，並提供便捷的門診治療，以取代重複手術。我們認為這是護理標準的重大轉變。

Historically, transurethral resection of bladder tumor, or TURBT, has been the only real option for patients with low-grade intermediate risk disease. TURBT is an invasive surgical procedure. It requires general anesthesia and access to an operating room, and it carries risks, especially in an older population. Patients are typically diagnosed with bladder cancer in their mid-70s, and many of these patients have comorbidities that make surgery under general anesthesia less than ideal. We also know this is a highly recurrent disease.

從歷史上看，經尿道膀胱腫瘤切除術（TURBT）一直是低度中度風險疾病患者的唯一真正選擇。TURBT 是一種侵入性手術。它需要全身麻醉並進入手術室，並且具有風險，尤其是在老年人群中。患者通常在 70 多歲時被診斷出患有膀胱癌，其中許多患者患有合併症，這使得全身麻醉下的手術不太理想。我們也知道這是一種復發率極高的疾病。

Approximately 68% of patients experience at least two recurrences and 23% will have five or more. That means multiple surgeries under general anesthesia and an ongoing burden that takes a toll on both physical health and quality of life, not to mention the burden placed on partners, family, and other caregivers.

約 68% 的患者會經歷至少兩次復發，23% 的患者會經歷五次或更多復發。這意味著需要在全身麻醉下進行多次手術，並承受持續的負擔，這會對身體健康和生活品質造成損害，更不用說對伴侶、家人和其他照護者造成的負擔。

In addition, repeated TURBT procedures may be associated with an increased risk of mortality. ZUSDURI offers a new nonsurgical treatment approach. ZUSDURI is administered as an intravesical installation via urinary catheter once a week for six weeks in a physician's office. No operating room, no general anesthesia and minimal recovery time.

此外，重複 TURBT 手術可能會增加死亡風險。ZUSDURI 提供了一種新的非手術治療方法。ZUSDURI 是透過導尿管在醫生辦公室進行膀胱內安裝，每週一次，持續六週。無需手術室，無需全身麻醉，恢復時間極短。

In many cases, a trained nurse can perform the procedure right in the urologist's office. For patients, this means a much less disruptive experience. For medical practices, it means increased OR availability for more complex procedures and an efficient in-office option that can streamline treatment delivery. The clinical data supporting ZUSDURI are both robust and continuing to mature.

在許多情況下，經過訓練的護理師可以直接在泌尿科醫師的辦公室內進行手術。對患者來說，這意味著更少干擾的體驗。對於醫療實踐而言，這意味著可以增加手術室可用於更複雜程序的可用性，並提供高效的診室內選項以簡化治療流程。支持 ZUSDURI 的臨床數據既可靠又不斷成熟。

In our ongoing pivotal Phase 3 ENVISION trial, 79% of patients achieved a complete response at three months following the completion of treatment. Equally important, however, is the durability of that response. In bladder cancer, long-term disease control is what truly improves outcomes and quality of life for patients.

在我們正在進行的關鍵性 3 期 ENVISION 試驗中，79% 的患者在完成治療後三個月內獲得了完全緩解。然而，同樣重要的是這種反應的持久性。對膀胱癌而言，長期疾病控制才是真正改善患者治療結果和生活品質的關鍵。

In our most recent update from ENVISION, which we shared earlier this week, we announced a 24-month duration of response of 72.2% by Kaplan-Meier estimate for patients who achieved a complete response of three months after the first installation of ZUSDURI. The sustained response observed offers real value to both patients and practices, allowing management of recurrence with greater confidence and extending the time between recurrences.

在我們本週稍早分享的 ENVISION 最新更新中，我們宣布，對於首次安裝 ZUSDURI 後三個月內達到完全緩解的患者，其 24 個月的緩解持續時間為 72.2%，這是根據 Kaplan-Meier 估計得出的。觀察到的持續反應為患者和實踐提供了真正的價值，使復發管理更加自信，並延長了復發之間的時間。

Importantly, the median duration of response has not been reached and the event rate has not accelerated and remained steady over time. According to the published literature, the median duration of response for TURBT in this population is approximately six to nine months with a substantial proportion of patients recurring within the first year.

重要的是，反應的中位數持續時間尚未達到，且事件發生率並未加速並隨時間保持穩定。根據已發表的文獻，該族群接受 TURBT 治療的中位反應持續時間約為六至九個月，其中相當一部分患者在第一年內復發。

These results are further supported by the five-year follow-up data from Phase 2 OPTIMA II study in both newly diagnosed and recurrent disease, which was published in the Journal of Clinical Genitourinary Cancer this past June. In that trial, of the 41 patients who achieved a complete response, the median duration of response was approximately two years by Kaplan-Meier estimate. Among the 17 patients who entered the five-year extension study, the median duration of response was 3.5 years.

這些結果得到了第二階段 OPTIMA II 研究的五年追蹤數據的支持，該研究針對新診斷和復發性疾病，於今年 6 月發表在《臨床泌尿生殖系統癌症雜誌》上。在該試驗中，41 名獲得完全緩解的患者中，根據 Kaplan-Meier 估計，緩解持續時間中位數約為兩年。在進入五年延長研究的 17 名患者中，平均反應持續時間為 3.5 年。

These data contribute to the growing and consistent body of evidence demonstrating that ZUSDURI is not only effective in achieving a complete response, but also offers durable disease control over time. We are very optimistic about the emerging long-term durability profile of ZUSDURI.

這些數據為不斷增長且一致的證據提供了支持，證明 ZUSDURI 不僅能夠有效實現完全緩解，而且還能夠長期提供持久的疾病控制。我們對 ZUSDURI 新興的長期耐久性特質非常樂觀。

I'll now briefly update you on the clinical pipeline. UGN-301 is our investigational anti-CTLA-4 antibody delivered via RTGel. It is currently being evaluated in the Phase 1 trial both as monotherapy and in combination with UGN-201, our TLR 7 agonist, and with gemcitabine. We shared the latest data at the AUA meeting in April. And the safety profile continues to be favorable across both the monotherapy and combination arms.

我現在將簡要地向您介紹臨床進展。UGN-301 是我們透過 RTGel 遞送的試驗性抗 CTLA-4 抗體。目前，正在進行 1 期試驗評估其作為單一療法以及與 UGN-201（我們的 TLR 7 激動劑）和吉西他濱聯合治療的效果。我們在四月的 AUA 會議上分享了最新數據。單一療法和聯合療法的安全性仍然良好。

We observed clinical responses in both monotherapy and combination arms with follow-up on the combination arms ongoing to evaluate the durability of response. We expect to share updated data later this year, and we'll use those results to guide a potential decision to move into Phase 2 development. As Liz mentioned earlier, we're also advancing our next-generation formulations of ZUSDURI and JELMYTO.

我們觀察了單一療法和聯合療法的臨床反應，並對聯合療法進行了持續的跟踪，以評估反應的持久性。我們預計將在今年稍後分享更新的數據，並將使用這些結果來指導進入第二階段開發的潛在決策。正如 Liz 之前提到的，我們也在推廣 ZUSDURI 和 JELMYTO 的下一代配方。

The Phase 3 UTOPIA trial is evaluating UGN-103, the successor to ZUSDURI, in patients with recurrent low-grade intermediate risk disease and has completed enrollment. This study is modeled closely on ENVISION. Efficacy will be measured by the complete response rate at three months with follow-up focused on assessing durability. We expect top-line complete response data by the end of this year, and we plan to share those results with the FDA to help inform the regulatory path forward.

第三階段 UTOPIA 試驗正在評估 ZUSDURI 的後繼者 UGN-103 對復發性低度中度風險疾病患者的作用，目前已完成招募。這項研究與 ENVISION 緊密相關。療效將透過三個月的完全緩解率來衡量，後續追蹤將重點評估持久性。我們預計今年底將獲得頂線完全緩解數據，並計劃與 FDA 分享這些結果，以幫助指導未來的監管路徑。

We are also taking a similar approach with UGN-104, our next-generation formulation of JELMYTO. We recently initiated a single-arm Phase 3 trial and patient screening is underway. UGN-501, our recently acquired next-generation oncolytic virus candidate, is progressing through IND-enabling studies, with a Phase 1 trial anticipated to begin next year. I will now turn the call over to David for the commercial update.

我們也對 JELMYTO 的下一代配方 UGN-104 採取了類似的方法。我們最近啟動了一項單臂 3 期試驗，患者篩選正在進行中。我們最近獲得的下一代溶瘤病毒候選藥物 UGN-501 正在進行 IND 支持研究，預計第一階段試驗將於明年開始。現在我將把電話轉給大衛，讓他介紹商業更新情況。

Thank you, Mark. As my colleagues have shared, we believe ZUSDURI represents a true shift in how recurrent low-grade intermediate risk non-muscle invasive bladder cancer is treated. Our focus now is on ensuring that all appropriate patients have access to ZUSDURI in an accelerated and successful launch. We have completed the expansion of our sales force, having increased the total number of reps from 50 to 82. With this footprint, we believe we are well positioned to reach the 8,500 healthcare providers who treat approximately 90% of the addressable patient population.

謝謝你，馬克。正如我的同事所分享的，我們相信 ZUSDURI 代表了復發性低級別中風險非肌肉浸潤性膀胱癌治療方式的真正轉變。我們現在的重點是確保所有合適的患者都能以更快、更成功的方式獲得 ZUSDURI。我們已經完成了銷售團隊的擴充，銷售代表總數從 50 人增加到 82 人。憑藉這一覆蓋範圍，我們相信我們有能力覆蓋 8,500 名醫療保健提供者，為大約 90% 的目標患者群體提供治療。

We view the launch in two distinct phases. The first phase covers the period from July through the end of this year. The second begins on January 1, 2026, when we expect to receive a permanent product-specific J-Code. That milestone will be an important catalyst for broadening adoption, particularly in the community setting, where reimbursement logistics play a critical role in treatment decisions. During the initial phase, our commercial priorities fall into three areas: engaging with healthcare providers, activating treatment sites, and advancing market access.

我們將發布分為兩個不同的階段。第一階段從今年7月開始一直到年底。第二個階段將於 2026 年 1 月 1 日開始，屆時我們預計將收到永久的特定產品 J-Code。這一里程碑將成為擴大採用的重要催化劑，特別是在社區環境中，報銷物流在治療決策中發揮關鍵作用。在初始階段，我們的商業重點分為三個方面：與醫療保健提供者合作、激活治療站點以及推進市場准入。

First, our field team is focused on building awareness, establishing clinical conviction, and ensuring providers and staff are educated on how ZUSDURI will benefit appropriate patients. Even at this early stage, we are encouraged by the level of interest we're seeing. Awareness around ZUSDURI is strong and healthcare providers are eager to learn about the profile of ZUSDURI and engage on appropriate patient types. Customer questions focus on the clinical, operational, and financial considerations to begin treating with ZUSDURI.

首先，我們的現場團隊致力於提高意識、建立臨床信念，並確保提供者和員工了解 ZUSDURI 如何使合適的患者受益。即使處於早期階段，我們也對所看到的興趣程度感到鼓舞。人們對 ZUSDURI 的認識很高，醫療保健提供者渴望了解 ZUSDURI 的概況並與適當的患者類型接觸。客戶的問題主要集中在開始使用 ZUSDURI 治療的臨床、操作和財務方面的考慮。

We are initially focused on a group of roughly 2,000 physicians out of our total 8,500 target universe, whom we've identified as likely early adopters. These are physicians who have demonstrated a willingness to introduce new therapies during a miscellaneous J-Code period. Our goal is to engage with the majority of accounts within the first six to eight weeks of launch, and we are making strong progress toward that target.

我們最初將重點關注總共 8,500 名目標群體中的大約 2,000 名醫生，我們將他們確定為可能的早期採用者。這些醫生已表現出願意在雜亂的 J-Code 期間引入新療法的意願。我們的目標是在發布後的前六到八週內與大多數帳戶互動，我們正在朝著這個目標取得重大進展。

Our discussions with physicians are focused on identifying patients who stand to benefit most from treatment with ZUSDURI. This typically involves those with multiple prior recurrences and a history of repeated TURBTs, patients experiencing early recurrences after surgery and patients who may be poor surgical candidates due to comorbidities or other risk factors. The second area of focus is site activation.

我們與醫生的討論重點是確定最能從 ZUSDURI 治療中受益的患者。這通常涉及那些曾多次復發和有重複 TURBT 病史的患者、手術後早期復發的患者以及由於合併症或其他風險因素而可能不適合手術的患者。第二個重點領域是站點啟動。

We are working closely with practices and hospitals to ensure operational readiness. This includes everything from distributor onboarding to clinical training and pharmacy processes. As we have noted previously, many providers prefer to initiate the use of new therapies like ZUSDURI in the hospital outpatient setting where hospital pharmacy budgets are often managed at separate cost centers. We are supporting this process, including working with P&T committees to ensure formulary placement as quickly as possible.

我們正在與診所和醫院密切合作，以確保營運準備就緒。這包括從分銷商入職到臨床培訓和藥房流程的所有內容。正如我們之前所指出的，許多供應商更願意在醫院門診環境中開始使用 ZUSDURI 等新療法，因為醫院藥局預算通常由單獨的成本中心管理。我們支持這項進程，包括與 P&T 委員會合作，以確保盡快實施處方集。

On the market access front, our team is actively engaged with major payers nationwide. At this stage, we have secured open access for approximately 84% of covered lives. These efforts are central to the launch and reflect our commitment to ensuring patients can access ZUSDURI without unnecessary administrative or financial barriers.

在市場准入方面，我們的團隊積極與全國主要付款人合作。目前，我們已確保約 84% 的受保人口能夠享有開放服務。這些努力對於此次發布至關重要，反映了我們致力於確保患者能夠在沒有不必要的行政或財務障礙的情況下存取 ZUSDURI。

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

展望 2026 年，永久 J 代碼的分配將大大簡化報銷流程。屆時，我們打算擴大我們的商業重點，涵蓋泌尿科市場的更廣泛領域，包括更多的社區實踐。

Turning to JELMYTO. We continue to drive strong year-over-year unit growth, which reflects growing comfort and conviction among urologists. We see steady growth in both the number of sites of care and the number of new prescribers, and we are encouraged by the positive trends in patient identification. The message around durability of response remains central and continues to resonate, and our team is maintaining high-frequency engagement with top-performing accounts to sustain momentum and drive further growth.

轉向 JELMYTO。我們持續推動強勁的同比單位成長，反映出泌尿科醫師的舒適度和信心不斷增強。我們看到醫療服務點的數量和新開處方者的數量都在穩步增長，患者識別的正面趨勢也令我們感到鼓舞。關於響應持久性的信息仍然是核心並繼續引起共鳴，我們的團隊正在與表現最佳的帳戶保持高頻互動，以保持發展勢頭並推動進一步增長。

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

現在我將把電話轉給 Chris Degnan 來報告財務最新情況。

Thank you, David. As Liz mentioned earlier, JELMYTO net product revenues were $24.2 million for the three months ended June 30, 2025, compared with $21.8 million in the same period in 2024. Year-over-year revenue growth of 11% was driven by underlying demand growth of 7% and price favorability as the gross to net rate for JELMYTO has stabilized in recent quarters.

謝謝你，大衛。正如 Liz 先前提到的，截至 2025 年 6 月 30 日的三個月，JELMYTO 淨產品收入為 2,420 萬美元，而 2024 年同期為 2,180 萬美元。營收年增 11%，這得益於潛在需求成長 7% 以及價格優惠，因為 JELMYTO 的毛利率在最近幾季已經穩定下來。

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

2025 年第二季的研發費用為 1,890 萬美元，其中包括 40 萬美元的非現金股權激勵費用。相較之下，2024 年同期為 1,540 萬美元，其中包括 60 萬美元的非現金股權激勵費用。

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

研發費用增加 350 萬美元，主要是由於 ZUSDURI 的製造成本增加以及與 UGN-103 的 3 期 UTOPIA 試驗相關的成本增加，但與 ZUSDURI 相關的臨床試驗成本和監管費用降低部分抵消了這一增加。

Selling, general and administrative expenses for the second quarter of 2025 were $43.2 million, including noncash share-based compensation expense of $2.3 million. This compares to $30.1 million, including noncash share-based compensation expense of $3 million for the same period in 2024. The year-over-year increase of $13.1 million was primarily driven by ZUSDURI commercial preparation activities as well as an increase in overall commercial costs.

2025 年第二季的銷售、一般和行政費用為 4,320 萬美元，其中包括 230 萬美元的非現金股權激勵費用。相較之下，2024 年同期為 3,010 萬美元，其中包括 300 萬美元的非現金股權激勵費用。年比增長 1,310 萬美元，主要由於 ZUSDURI 商業準備活動以及整體商業成本的增加。

We reported noncash financing expense related to the prepaid forward obligation to RTW Investments of $4.6 million in the second quarter of 2025 compared to $5.8 million in the same period in 2024. Interest expense related to the term loan facility with funds managed by Pharmakon Advisors was $4.1 million in the second quarter of 2025 compared to $3.5 million in the same period in 2024. The increase was primarily driven by interest expense related to the third tranche of the loan that was funded in September 2024.

我們報告稱，2025 年第二季與預付給 RTW Investments 的遠期債務相關的非現金融資費用為 460 萬美元，而 2024 年同期為 580 萬美元。2025 年第二季度，與 Pharmakon Advisors 管理的基金定期貸款相關的利息支出為 410 萬美元，而 2024 年同期為 350 萬美元。成長的主要原因是 2024 年 9 月發放的第三筆貸款相關的利息支出。

We do not intend to draw down the fourth and final tranche of $75 million that is available to us at our discretion until August 29, 2025. Net loss was $49.9 million or $1.05 per basic and diluted share in the second quarter of 2025 compared to a net loss of $33.4 million or $0.82 per basic and diluted share in the same period in 2024. As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $161.6 million.

我們不打算在 2025 年 8 月 29 日之前提取第四筆也是最後一筆 7500 萬美元的可自行支配資金。2025 年第二季淨虧損為 4,990 萬美元，即每股基本虧損和稀釋虧損均為 1.05 美元，而 2024 年同期淨虧損為 3,340 萬美元，即每股基本虧損和稀釋虧損均為 0.82 美元。截至 2025 年 6 月 30 日，現金、現金等價物及有價證券總額為 1.616 億美元。

Turning now to guidance. Our full-year guidance for JELMYTO remains unchanged. We continue to expect full-year 2025 net product revenues from JELMYTO to be in the range of $94 million to $98 million, and this implies year-over-year growth of approximately 8% to 12% over the $87.4 million in demand-driven JELMYTO sales in 2024. This excludes the $3 million in CREATES Act sales reported in 2024.

現在轉向指導。我們對 JELMYTO 的全年指導保持不變。我們繼續預期 2025 年全年 JELMYTO 的淨產品收入將在 9,400 萬美元至 9,800 萬美元之間，這意味著 2024 年受需求驅動的 JELMYTO 銷售額將比 8,740 萬美元年增約 8% 至 12%。這還不包括 2024 年報告的 300 萬美元 CREATES 法案銷售額。

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.

2025 年全年營運費用指引也維持不變，預計在 2.15 億美元至 2.25 億美元之間，其中包括 1,100 萬美元至 1,400 萬美元的非現金股權激勵費用。

We anticipate operating expenses to decrease modestly over the remainder of the year, reflecting the impact of several nonrecurring costs incurred during the first half of 2025, partially offset by the sales force expansion in the second half of the year. These nonrecurring costs totaled approximately $15 million and included expenses related to the acquisition of UGN-501, preparations for the ZUSDURI ODAC, our national launch meeting for ZUSDURI, and manufacturing expenses for ZUSDURI, which were accounted for as R&D expense prior to FDA approval.

我們預計今年剩餘時間內的營運費用將小幅下降，這反映了 2025 年上半年發生的幾項非經常性成本的影響，但部分被下半年銷售隊伍的擴張所抵消。這些非經常性成本總計約 1500 萬美元，包括與收購 UGN-501 相關的費用、ZUSDURI ODAC 的準備工作、ZUSDURI 的全國發布會議以及 ZUSDURI 的製造費用，這些費用在 FDA 批准之前被記為研發費用。

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

我們的準備好的演講到此結束。我們現在準備開始提問。操作員？

(Operator Instructions) Tara Bancroft, TD Cowen.

（操作員指示）Tara Bancroft，TD Cowen。

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

感謝您回答這個問題。因此我必須問大家心中必問的第一個問題。您能否提供一些關於 7 月份迄今為止所達到的指標的信息，例如處方率、活躍帳戶或處方者的數量，或者任何定性信息，例如那些可能正在等待 TURBT 而希望獲得 ZUSDURI 的人的被壓抑需求水平，如果有的話，諸如此類的事情？

Yeah. A great question, Tara. It's Liz. And I'm going to ask David to comment, and then I'll probably add some color as well. So David?

是的。塔拉，這個問題問得好。是莉茲。我將請大衛發表評論，然後我可能也會添加一些顏色。那麼大衛？

Yeah. Thanks for the question. We're really excited by the positive receptivity of not only the healthcare providers that we have engaged, but also the payer community. As we heard prior to launch, they're very eager for a new treatment option, and they took on the ZUSDURI product profile with great enthusiasm. So we are very pleased with how we've heard about it.

是的。謝謝你的提問。我們非常高興，不僅與我們合作的醫療保健提供者，而且付款人社區也表現出了積極的接受態度。正如我們在產品發布前所聽到的，他們非常渴望一種新的治療選擇，並且他們對 ZUSDURI 產品表現出了極大的熱情。因此，我們對這一消息感到非常高興。

In the stage of the launch, as we said, we're really actively engaging physicians. We're helping them identify sites of care. And importantly, we're also continuing to make sure that market access -- we laid the groundwork for market access so that all the patients have access to the product per label. So anyway, thank you for the question, and we'll be looking forward to sharing more results in the future.

正如我們所說，在發布階段，我們確實積極地與醫生接觸。我們正在幫助他們確定護理地點。重要的是，我們還將繼續確保市場准入——我們為市場准入奠定了基礎，以便所有患者都能根據標籤獲得產品。無論如何，感謝您的提問，我們期待將來分享更多結果。

Yeah. Tara, look, I'll give you a little bit more color on that. One, we're not going to give metrics at this point. I'm sure everybody would love to have them, but it's still very early for us. What I will tell you is that we've all been spending a lot of time out in the field and talking to doctors.

是的。塔拉，聽著，我會給你更詳細地講解這一點。首先，我們目前不會給予指標。我相信每個人都希望擁有它們，但對我們來說還為時過早。我要告訴你們的是，我們都花了很多時間在現場與醫生交談。

And to David's point, there's a lot of excitement. And what you hear from doctors is they all have patients. And I want to sort of put a note on patients, because when we launched JELMYTO, it's like I have a patient. And when we talk to doctors today, they have several patients. The biggest hurdle, frankly, is reimbursement, which we knew that.

正如大衛所說，這讓人非常興奮。而你從醫生那裡聽到的是，他們都有病人。我想給病人一些提示，因為當我們推出 JELMYTO 時，就像我有一個病人一樣。當我們今天與醫生交談時，他們有幾位病人。坦白說，最大的障礙是報銷，我們知道這一點。

I can tell you that I went to an event last week with a lot of community practices and doctors and the first thing they say is, as soon as you get a permanent J-Code, I've got patients waiting. We don't and we've always said there would not be a bolus of patients. But again, what I can tell you is that our PEFs are coming in, patient enrollment forms. So the top of the funnel, we're very happy with where we're going there. And the team, as David said, is working on the sites of care, pulling those through, and dosing -- really getting patients dosed.

我可以告訴你，上週我參加了一個有很多社區診所和醫生參加的活動，他們說的第一件事就是，只要你獲得永久的 J-Code，就會有病人在等著。我們不會，而且我們一直說不會有大量患者。但我可以再次告訴你們的是，我們的 PEF 正在進來，即病患登記表。因此，對於漏斗頂部的情況，我們感到非常滿意。正如戴維所說，該團隊正在護理現場開展工作，將這些藥物輸送到患者手中並進行給藥——真正為患者提供藥物。

So I would say at this point, we're very optimistic. We feel really good about where we are. We think the consensus, as we said for the year, we are still aligned with that and have the opportunity to see some real uptake over the next few months. I do think David commented this in the prepared remarks that you will see an acceleration after the first of the year when we have the J-Code.

所以我想說，目前我們非常樂觀。我們對目前的狀況感到非常滿意。我們認為，正如我們今年所說的那樣，我們仍然與這一共識保持一致，並有機會在未來幾個月看到一些真正的成長。我確實認為大衛在準備好的評論中評論了這一點，當我們擁有 J-Code 時，您將在年初之後看到加速。

But we have hospitals, we have institutions, and we've got some large practices that are all willing to write. So it's not like no one is willing to take -- to do it during the miscellaneous code. But you do see a big difference in sort of attitude kind of before and after.

但是我們有醫院，有機構，還有一些大型診所都願意寫。所以並不是沒有人願意在雜項程式碼期間做這件事。但你確實看到前後態度上的巨大差異。

But the good news is, is that all of the metrics, the feedback we're getting –- I have not talked to one doctor who said, no, I don't see a role for this. And none of them, frankly, that say they're going to really limit it. So again, a lot of excitement around using this in multiple patients in their practice.

但好消息是，根據我們得到的所有指標和回饋，我還沒有遇到一位醫生說「不，我不認為這有什麼作用」。坦白說，沒有一個人說他們會真正限制它。因此，他們在實踐中對多名患者使用這種方法感到非常興奮。

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

因此希望額外的顏色能夠有所幫助，而無需提供非常具體的數字。但大衛也提到了護理地點。我們已經建立了許多護理站點，我們正在按照既定計劃完成今年的護理站點數量，以實現我們承諾的目標。希望這能有所幫助。

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

是的。這一切都非常有幫助。太感謝了。

Michael Schmidt. Guggenheim.

邁克爾·施密特。古根漢。

Thanks for taking my questions. Perhaps a follow up just on the early launch. Yeah, we've certainly had some very positive feedback from urologists as well that we spoke with in terms of intent to prescribe the therapy. But just curious what you're seeing so far around the reimbursement process early on using the miscellaneous codes.

感謝您回答我的問題。也許只是對早期發布的後續行動。是的，我們確實也從泌尿科醫生那裡得到了一些非常積極的回饋，我們在開這種療法的意向方面也與他們進行了交談。但我只是好奇到目前為止，您看到使用雜項程式碼的早期報銷流程是什麼樣的。

Just curious if you could comment perhaps how much time it takes in terms of intent to prescribe until sort of conversion to paid prescription? Or anything along those lines would be helpful. And then I have a follow up.

我只是好奇，您是否可以評論一下，從開處方意向到轉換為付費處方需要多長時間？或者任何類似的事情都會有幫助。然後我有一個後續行動。

Yeah, sure. Go ahead, David.

是的，當然。繼續吧，大衛。

Yeah. Thanks for your question, Michael. I'll just comment on the initial process in terms of educating accounts. So as we discussed in our prepared remarks, we are really focused on a group of around 2,000 providers that have demonstrated a willingness to adopt product during this particular period. And so that's pretty much what we're seeing in terms of interest right there. One of the things we do, which is very similar to what we did with JELMYTO at that launch, is we spend a good amount of time educating them on the actual process for claims and billing and then reimbursement.

是的。謝謝你的提問，麥可。我只想對帳戶教育的初始過程進行評論。因此，正如我們在準備好的發言中所討論的那樣，我們真正關注的是一群約 2,000 家供應商，他們已表現出願意在此特定時期採用產品。這就是我們所看到的興趣。我們所做的事情之一與我們在 JELMYTO 發佈時所做的事情非常相似，那就是我們花了大量時間向他們講解索賠、計費和報銷的實際流程。

So we educate them fully on that. So it's white glove service. And with that, they have the reassurance of knowing they've -- when they enroll a patient, they know what that patient's co-pay is going to be, they know what the coverage is going to be, and the office feels more reaffirmed in terms of how that process is going to work.

因此，我們對此進行了充分的教育。所以這是白手套服務。這樣，他們就可以放心地知道——當他們登記一名患者時，他們知道該患者的共同支付額是多少，他們知道保險範圍是多少，並且辦公室對於該流程將如何運作感到更加放心。

As you know, with the miscellaneous J-Code period, it is a little bit of a different process because it's manual. But what we're seeing so far is that when we engage the practices, they feel assured that what they're doing is setting them up for a positive experience.

如您所知，對於雜項 J-Code 期間，由於它是手動的，因此過程略有不同。但到目前為止我們看到的是，當我們參與這些實踐時，他們感到確信他們所做的事情正在為他們帶來積極的體驗。

But too early to give -- too early, so we haven't had any, quote-unquote, paid claims, yet. So it's too early to sort of say how long is it going to take. As we start to see that coming through, we'll be able to give you more color on that. But it's too early to see that.

但現在下結論還為時過早了，所以我們還沒有收到任何所謂的已付索賠。所以現在說這要多久還太早。當我們開始看到這一點時，我們將能夠為您提供更多詳細資訊。但現在判斷這一點還為時過早。

Right. And then I guess if you were to compare the initial experience of the ZUSDURI launch to your experience with JELMYTO five years ago, I guess, how much commercial synergies are there in place today given your commercial footprint around the JELMYTO product? And any key learnings that -- as you launch ZUSDURI essentially into a very similar market here?

正確的。然後我想，如果您將 ZUSDURI 的首次推出體驗與五年前 JELMYTO 的推出體驗進行比較，那麼，考慮到您在 JELMYTO 產品周圍的商業足跡，今天有多少商業協同效應？當您將 ZUSDURI 引入這裡一個非常相似的市場時，您有什麼關鍵的經驗嗎？

Yeah. Since Mark and I were the only two people here when we launched JELMYTO, I'll give you some comment and ask Mark to add anything. I think the –- it's similar in a lot of ways in the sense of what you have to deal with the J-Code, what you have to deal with reimbursement, what you have to deal with identifying patients, and what you have to deal with, frankly, for an office to get set up, set up with the distributor. The good news is, obviously, a lot of these offices are already set up. So all we have to do is add in ZUSDURI where they already were.

是的。由於我們推出 JELMYTO 時只有我和馬克兩個人在這裡，所以我會給你一些評論，並請馬克添加任何內容。我認為——在很多方面都是相似的，例如你必須處理 J-Code、你必須處理報銷、你必須處理識別患者，坦白說，你必須處理設立辦事處、與經銷商建立聯繫等。好消息是，顯然很多這樣的辦公室已經設立了。因此，我們所要做的就是在原有的位置加入 ZUSDURI。

So there is a little bit of paperwork that happens there. Absolutely, some of the first physicians that we see that are writing for ZUSDURI are writers of JELMYTO, which makes a lot of sense. And I think the -- what we also are seeing is that for the most part, people were really happy with the support that we gave them with JELMYTO and are happy with the support that they're getting.

因此那裡需要處理一些文書工作。當然，我們看到的第一批為 ZUSDURI 撰稿的醫生中有一些是 JELMYTO 的作者，這很有道理。我認為——我們也看到，大多數人對我們透過 JELMYTO 給予他們的支持感到非常滿意，並且對他們現在所得到的支持感到滿意。

Again, the physicians that I've personally interacted with have commented about particularly our reimbursement team because that's the number one thing right now and how good they are, how knowledgeable they are, how helpful they are.

再次，與我親自接觸過的醫生們對我們的報銷團隊發表了特別的評價，因為這是目前的首要任務，他們非常優秀，知識淵博，樂於助人。

And then I'm going to let Mark talk about the numbers because I think that's a big, big difference between what you -- what we heard when we launched JELMYTO versus what we're hearing now. So Mark?

然後我將讓馬克談論這些數字，因為我認為，當我們推出 JELMYTO 時聽到的消息與我們現在聽到的消息之間存在很大差異。那麼馬克？

Yeah. Thanks, Liz. So it's, I think, obvious to many on the call that we're dealing with a completely different demographic, so to speak, a demographic opportunity. Upper tract urothelial carcinoma, the target of JELMYTO use, is a very small population of patients. And on average, most practicing urologists will see one or two patients a year.

是的。謝謝，莉茲。因此，我認為，對於電話會議中的許多人來說，很明顯，我們正在處理一個完全不同的人口統計數據，可以這麼說，這是一個人口統計數據機會。JELMYTO 的應用對像是上泌尿道尿路上皮癌，而此類患者的數量非常少。平均而言，大多數執業泌尿科醫師每年會接診一到兩名患者。

So it's hard to find the patients and it's hard to find individuals to treat with JELMYTO, which I think explains a lot of the experience of why the JELMYTO ramp has been what it has been. That's very different than what we're dealing with, with the ZUSDURI launch. There are lots of patients who qualify by the label alone for the use of this drug, and physicians are exceedingly familiar with this population of patients. These are people we're seeing in the office on a very regular basis.

因此很難找到患者，也很難找到 JELMYTO 治療的個人，我認為這在很大程度上解釋了 JELMYTO 的療效。這與我們所處理的 ZUSDURI 發射情況非常不同。有許多患者僅憑標籤就有資格使用這種藥物，醫生對這類患者非常熟悉。這些人是我們在辦公室經常見到的人。

So I do think -- although as Liz pointed out, many of the sort of mechanical issues related to bringing the drug into the practice are similar and will be familiar to people who have used JELMYTO. The opportunity, the ease of administration, the fact that this can be given in an office with essentially minimal physician involvement, this can be given by a nurse, will really change the way the ZUSDURI experience looks compared to our experience previously with the JELMYTO launch.

所以我確實認為——儘管正如 Liz 指出的那樣，將藥物帶入實踐中所涉及的許多機械問題都是相似的，並且對於使用過 JELMYTO 的人來說很熟悉。這種機會、管理的簡便性、可以在辦公室進行、醫生幾乎不參與的事實以及可以由護士進行的事實，將真正改變 ZUSDURI 的體驗，與我們之前推出 JELMYTO 的體驗相比。

Let's just squeeze one more in, and this one is on UGN-103. And so now with the UTOPIA study fully enrolled, I was just curious if you had the chance to have any additional discussions with the regulators in terms of sort of coming off of the panel earlier this year in terms of whether the study is, in fact, supportive of potential approval?

我們再擠進一個，這個在 UGN-103 上。現在 UTOPIA 研究已經完全招募完畢，我很好奇您是否有機會與監管機構進行進一步討論，就今年早些時候的小組討論而言，這項研究是否確實支持潛在的批准？

And from a clinical perspective, is the goal to essentially reproduce the ENVISION data? Or is there opportunity to differentiate clinically with 103?

從臨床角度來看，目標基本上是否是重現 ENVISION 資料？或者是否有機會透過臨床與 103 進行區分？

Yeah. No, a great question. We have not interacted. It's -- we don't have enough data yet. So we're waiting on additional data before we interact with the FDA. But we will absolutely do that and have feedback for you prior to the end of this year. So I think that's the timing on that.

是的。不，這是一個很好的問題。我們沒有互動。這是——我們還沒有足夠的數據。因此，在與 FDA 互動之前，我們正在等待更多數據。但我們絕對會這樣做，並在今年年底之前向您提供反饋。所以我認為時機已經成熟。

The goal is to replicate. And we actually purposely did that because what we didn't want to do is introduce any potential issues, right, that would muddy the waters as far as the data is concerned. So we tried to replicate almost exactly the ENVISION study. So there -- unfortunately, there's no differentiation.

目標是複製。我們實際上是故意這樣做的，因為我們不想引入任何潛在問題，對吧，這會混淆數據。因此，我們嘗試幾乎完全複製 ENVISION 研究。所以，不幸的是，沒有差別。

But fortunately, what we're doing is trying not to introduce any biases. Our expectation is that the FDA will accept the study as they had previously communicated, mainly because this is a new formulation. And they actually have UGN-102, ZUSDURI, as a historical control now. So we do plan to interact again with them.

但幸運的是，我們正在努力避免引入任何偏見。我們的期望是 FDA 能夠像他們之前傳達的那樣接受這項研究，主要是因為這是一種新的配方。現在他們實際上已經擁有 UGN-102、ZUSDURI 作為歷史控制。所以我們確實計劃再次與他們互動。

We'll have feedback for you before the end of the year. But that's our expectation and that's what we're moving forward with. Having said that, we and ourselves want to continue to expand the use of UGN-103. So we are in the planning of additional life cycle management studies that we will start fairly quickly on UGN-103 regardless of the FDA feedback. But we have other studies that we want to do in other populations, and we'll be starting those as quickly as possible.

我們將在年底前給您回饋。但這是我們的期望，也是我們前進的方向。話雖如此，我們自己都希望繼續擴大 UGN-103 的使用。因此，我們正在計劃進行額外的生命週期管理研究，無論 FDA 的回饋如何，我們都將很快開始對 UGN-103 進行研究。但我們想在其他人群中進行其他研究，我們將盡快開始這些研究。

Thank you.

謝謝。

Leland Gershel, Oppenheimer.

利蘭·格謝爾，奧本海默。

Thanks for taking our question. A few from us. With respect to the first phase of the launch pre the J-Code assignment, I'm wondering, as you're going after those 2,000 docs you've identified as early adopters, can you share what -- how those break down with respect to community versus academic docs? Should we think of the academic -- those who practice in an academic setting as maybe having easier access to the medication?

感謝您回答我們的問題。我們中的一些人。關於 J-Code 任務啟動之前的第一階段，我想知道，當您追蹤那些被確定為早期採用者的 2,000 份文檔時，您能否分享一下——這些文檔在社區文檔和學術文檔方面是如何細分的？我們是否應該認為學者──那些在學術環境中實踐的人可能更容易獲得藥物？

Is the miscellaneous J-Code easier in the hospital setting or through that process? Is there a P&T committee dynamic that we should consider for ZUSDURI in the hospital setting? If you could share, yeah, any color around that as we think about 2025 sales before the J-Code kicks in.

在醫院環境中或透過該流程處理雜項 J-Code 是否更容易？我們是否應該考慮在醫院環境中為 ZUSDURI 建立 P&T 委員會動態？是的，如果您可以分享一下，在我們考慮 J-Code 生效之前的 2025 年銷售情況時，您對此有何看法？

Yeah, absolutely. David?

是的，絕對是如此。戴維？

Yeah. Thanks, Leland. The majority of that 2,000 physician, I'll say, early adopter list that we've identified reside in the community, and there are some in institutional settings. And as you know, some have privileges in hospitals as well. So when we think about them gaining access to ZUSDURI, it is -- there's a spectrum. In private practice, as we've mentioned, there's historically some hesitation there.

是的。謝謝，利蘭。我想說，在我們確定的早期採用者名單中，這 2,000 名醫生大多居住在社區中，還有一些居住在機構環境中。而且如你所知，有些人在醫院也享有特權。因此，當我們考慮讓他們獲得 ZUSDURI 的存取權限時，這是一個範圍。正如我們所提到的，在私人執業中，歷史上存在著一些猶豫。

And so what we try to do is help them identify a site of care where they can administer ZUSDURI for the first time and gain experience. And that often is in a hospital outpatient setting. If it is a specific hospital account, I think that process varies. But generally speaking, you'll see that they have formal P&T reviews.

因此，我們嘗試做的是幫助他們找到一個可以首次管理 ZUSDURI 並累積經驗的護理地點。這通常發生在醫院門診。如果是特定的醫院帳戶，我認為流程會有所不同。但一般來說，你會看到他們有正式的 P&T 評論。

And so one of the things we did immediately upon launch was engaged major accounts so that we could begin working with them to provide the clinical, the operational and financial information to support a successful P&T review.

因此，我們在推出後立即採取的措施之一就是與主要客戶接洽，以便我們可以開始與他們合作，提供臨床、營運和財務信息，以支持成功的 P&T 審查。

Okay. Great. And then just another question with respect to the UTOPIA trial. Do you think the FDA would ask for longer durability data or anything that may be incremental to what was shown with ENVISION? Or do you think it truly would be kind of a replicate of the ENVISION data set that could get 103 approved?

好的。偉大的。然後是關於 UTOPIA 試驗的另一個問題。您認為 FDA 會要求提供更長時間的耐久性資料或任何可能與 ENVISION 所示內容有增量的資料嗎？或者您認為它真的可以成為 ENVISION 資料集的複製品，從而獲得 103 項批准？

Thanks Leland. Yeah, we are expecting it to be similar to what we presented for ENVISION. We're going to talk to the FDA about their expectations. But our expectation is that it would be -- it would mirror similar types of requirements as ENVISION, namely concentrating on CR with some reasonable amount of durability data. And that would obviously be something that we have to talk to the agency about.

謝謝 Leland。是的，我們期望它與我們為 ENVISION 展示的類似。我們將與 FDA 討論他們的期望。但我們的期望是——它將反映與 ENVISION 類似的要求，即專注於 CR 並提供一些合理數量的耐久性數據。顯然，我們必須與該機構討論此事。

Okay. Thank you.

好的。謝謝。

Raghuram Selvaraju, HC Wainwright & Company.

Raghuram Selvaraju，HC Wainwright & Company。

Thanks so much for taking our questions. And congratulations on all the progress so far. I wanted to ask, first of all, about clarification of a couple of commercial things. Firstly, you alluded to once the formal J-Code designation is complete at the beginning of next year, that there would be outreach facilitated by this to a broader group of prescribers. Can you maybe quantify for us how many more prescribers are likely to be targetable beyond the initial 2,000?

非常感謝您回答我們的問題。並祝賀迄今為止的所有進展。首先，我想問一些商業問題的澄清。首先，您提到，一旦明年年初 J-Code 正式指定完成，這將有利於更廣泛的處方者群體獲得服務。您能否為我們量化一下，除了最初的 2,000 名處方醫生之外，還有多少人可能成為目標？

And then also, I wanted to ask if you are seeing any evidence that the commercial availability of ZUSDURI and the increased visibility of the company overall is having any potential beneficial spillover effects on JELMYTO itself? And if you're seeing any noteworthy reacceleration of momentum in JELMYTO because ZUSDURI is now available?

另外，我想問一下，您是否看到任何證據表明 ZUSDURI 的商業可用性和公司整體知名度的提高對 JELMYTO 本身產生了任何潛在的有益溢出效應？您是否看到 JELMYTO 的發展勢頭因 ZUSDURI 現已推出而出現任何值得注意的復甦？

Yeah. Thanks, Ram. David?

是的。謝謝，拉姆。戴維？

Ram, thanks for the question. So on your question around how we're going to engage the total universe. So as we said, we are focused on the 2,000 that we think are very important to the early stages of a launch. It doesn't mean that we won't see others in the universe if they're in the same office. But broadly speaking, as we turn the corner into 2026, we will expand our efforts beyond that 2,000 and we'll begin very rapidly then expanding our reach to a greater number of them. So I would say by the middle of next year, we're going to see -- we're going to be broadly engaging everyone in that total universe.

Ram，謝謝你的提問。那麼關於你的問題，我們將如何參與整個宇宙。正如我們所說，我們專注於我們認為對發布初期非常重要的 2,000 個。這並不意味著如果宇宙中的其他人在同一個辦公室，我們就不會看到他們。但從廣義上講，隨著我們進入 2026 年，我們將把我們的努力擴展到 2,000 家以上，我們將迅速開始，然後擴大我們的覆蓋範圍，涵蓋更多的公司。所以我想說，到明年年中，我們就會看到——我們將廣泛地吸引整個宇宙中的每個人。

And keep in mind that universe also includes in each office, there's physician assistants, there's nurses. So our efforts go well beyond just the HCP. With regard to your question on JELMYTO, it's too early to say that. But what I can tell you what we've observed so far is that, as Liz mentioned, those who have used JELMYTO definitely understand the technology behind ZUSDURI.

請記住，宇宙還包括每個辦公室，有醫師助理，有護士。因此，我們的努力遠遠超出了 HCP 的範圍。關於您對 JELMYTO 的疑問，現在說這個還為時過早。但我可以告訴你，到目前為止我們觀察到的情況是，正如 Liz 所提到的，那些使用過 JELMYTO 的人肯定了解 ZUSDURI 背後的技術。

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

我想說的是，隨著時間的推移，隨著我們滲透到低度中度風險非肌肉層侵襲性膀胱癌和 ZUSDURI 的整體市場，我們將看到，宇宙覆蓋面和頻率的增加將支持 JELMYTO 的持續穩定增長。

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

偉大的。然後僅針對 UGN-103 進行一次跟進。我想知道，此時此刻，您是否有理由相信，由於新配方的特性，103 可能在安全性、耐受性或易於管理方面比 ZUSDURI 本身俱有優勢？

Ram, thank you. The answer is we don't, and we didn't expect any real changes. For the audience, just to remind you, the principal issues related to this formulation relate to solubility, ease of reconstitution related to a change in the excipients of the preparation. But we don't expect a change in terms of the clinical profile, and it's premature for us to talk further about that, and we will be happy to share those data when we have them later in the year.

拉姆，謝謝你。答案是，我們不知道，而且我們也不期待任何真正的改變。對於觀眾，只需提醒您，與該配方相關的主要問題涉及溶解度，與製劑賦形劑的變化相關的重構的容易性。但我們並不期望臨床特徵發生變化，現在進一步討論這個問題還為時過早，當我們在今年稍後獲得這些數據時，我們將很樂意分享這些數據。

Thank you.

謝謝。

(Operator Instructions) Paul Choi, Goldman Sachs.

（操作員指示）高盛的 Paul Choi。

Thanks for taking our question. I also want to follow up on UTOPIA and maybe ask, is there anything in terms of either the data or product profile that you might call out that would allow you to address additional segments of the low-grade intermediate risk population that you feel like you can't currently tap with ZUSDURI? And just sort of would there be any sort of incremental subset of patients that might be better candidates for that product?

感謝您回答我們的問題。我還想跟進 UTOPIA 的情況，也許想問一下，在數據或產品概況方面，您是否可以指出一些內容，讓您能夠解決低級中等風險人群中的其他部分，而您認為目前無法通過 ZUSDURI 來解決這些部分？那麼，是否有任何種類的增量患者子集可能更適合該產品？

And my second question on ZUSDURI is just, I guess, as you think about sort of the product procedural flow in doctors' offices, can you maybe just comment on how you're thinking about nonphysicians such as licensed nurses practitioners as a percentage of the mix? And are there other requirements for non-urologists to use the product? Thanks for taking our questions.

我關於 ZUSDURI 的第二個問題是，我想，當您考慮醫生辦公室的產品程序流程時，您能否評論一下您如何看待非醫生（例如持照護士）在其中所佔的比例？非泌尿科醫師使用該產品還有其他要求嗎？感謝您回答我們的問題。

Go ahead, Mark. Do you want to answer the UTOPIA question? Are there any --

繼續吧，馬克。您想回答 UTOPIA 問題嗎？有沒有--

Yeah, sure. Paul, thank you for that. So the answer to the first question is no. As Liz mentioned, we are really formatting the evaluation of 103 in the UTOPIA trial in exactly the same manner as we did ZUSDURI and ENVISION. So it would be applicable to the same population of patients, and we wouldn't expect a change in terms of the target population it would be used in initially.

是的，當然。保羅，謝謝你。所以第一個問題的答案是否定的。正如 Liz 所提到的，我們實際上正在以與 ZUSDURI 和 ENVISION 完全相同的方式對 UTOPIA 試驗中的 103 進行評估。因此它適用於相同的患者群體，我們預計它最初適用的目標群體不會發生變化。

\What you're anticipating, I think, in your question is the possibility of us doing additional clinical trials, which is something we have to talk about and think about and Liz will ultimately make a decision about. But currently, the plan is for the same group of patients with that drug when it becomes available and is approved.

\我認為，您在問題中預期的是，我們可能會進行額外的臨床試驗，這是我們必須討論和思考的事情，莉茲最終會做出決定。但目前，該計劃是針對同一組患者，待該藥物上市並獲得批准後再進行治療。

Yeah. But as I mentioned earlier, we absolutely expect to expand UGN-103 into other patient populations, but not because it's different than ZUSDURI, right, from a clinical perspective, but just because we would be doing that with UGN-102. So it makes more sense for us to be doing that with UGN-103, assuming the data is very similar as we start to -- as the data starts to play out. But that's our expectation.

是的。但正如我之前提到的，我們絕對希望將 UGN-103 擴展到其他患者群體，但這並不是因為從臨床角度來看它與 ZUSDURI 不同，而只是因為我們會對 UGN-102 這樣做。因此，當我們開始研究數據時，假設數據非常相似，那麼使用 UGN-103 進行這項研究就更有意義了——當數據開始發揮作用時。但這是我們的期望。

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

因此，我們絕對會擴展到其他患者群體，但實際上不會受到我們看到的任何差異的影響。大衛，你想回答有關 ZUSDURI 的問題嗎？

Yeah. So on the question of ZUSDURI and actually who might be administering this in the office, what we're hearing early on is that, obviously, the physician will want to be understanding the entire process, the ordering all the way through administration. But we do expect and we've heard this consistently that as practices get more experience, that it will really fall on the shoulders of someone specifically who does intravesical therapies, likely a nurse. A

是的。因此，關於 ZUSDURI 的問題以及實際上誰可能在辦公室管理這個問題，我們很早就聽到的是，顯然，醫生希望了解整個過程，從下令到管理的整個過程。但我們確實期望並且我們也一直聽到這樣的觀點：隨著實踐經驗的增加，這項任務將真正落在專門進行膀胱內治療的人的肩上，例如護士。一個

And so that's pretty much what we're hearing right now, consistent with what we learned before launch.

這就是我們現在聽到的，與我們在發布之前了解到的信息一致。

And we are engaging all people in the practice, right, everybody from physicians to your PAs to your -- the reimbursement team. So from that perspective, included in the 8,500 targets are other targets outside of physicians. So we'll continue to do that. This is a full –- a comprehensive account sell, it needs to be. But in the beginning, clearly, the physicians' conviction around wanting to use it is going to drive the early adoption.

我們讓所有人都參與實踐中來，從醫生到你的私人助理，再到你的報銷團隊。因此從這個角度來看，8,500 個目標中還包括醫生以外的其他目標。因此我們會繼續這樣做。這是一個完整的——一個全面的帳戶銷售，它需要如此。但一開始，顯然醫生想要使用它的信念將推動早期採用。

Aydin Huseynov, Ladenburg.

拉登堡的艾登‧胡賽諾夫 (Aydin Huseynov)。

Thank you for taking the questions. Congrats on the quarter. A good couple of questions I want to ask. So first, I wanted to ask that if there were not questions about permanent J-Code, if we didn't have issues with J-Code this year, permanent J-Code this year, how many patients do you think it would be possible for you to dose in 2025?

感謝您回答這些問題。恭喜本季取得佳績。我想問幾個好問題。所以首先，我想問一下，如果沒有關於永久性 J-Code 的問題，如果我們今年沒有遇到 J-Code 問題，今年是永久性 J-Code，您認為 2025 年可以為多少患者進行治療？

So the reason I'm asking because ENVISION trial enrolled very quickly, I think, 220 patients, 10 months across 90 sites. I was trying to understand if we did not have reimbursement issues at this point, so how many patients would it be possible to dose in 2025?

我之所以問這個問題，是因為 ENVISION 試驗招募速度非常快，我記得有 220 名患者，在 90 個地點進行了 10 個月的招募。我想了解的是，如果我們現在沒有報銷問題，那麼到 2025 年可以為多少患者提供藥物治療？

Yeah. Look, that's a great question, not one that we're going to speculate on. But suffice to say that absolutely it's a significant number of patients. As I mentioned earlier, the number one barrier right now is reimbursement. It's not around the desire for clinical use.

是的。瞧，這是一個很好的問題，我們不需要去猜測。但可以肯定地說，這絕對是相當多的患者。正如我之前提到的，目前最大的障礙是報銷。這與臨床應用的願望無關。

And that's a good thing. That's a really good thing. I mean, rarely do you roll out where there's no question -- more questions around the clinical data, the clinical use, the patient identification, and we're not hearing that. The only -- again, in all the conversations I've had, it's only been around reimbursement.

這是一件好事。這真是一件好事。我的意思是，很少會推出沒有任何疑問的產品——更多的是有關臨床數據、臨床使用、患者識別的問題，而我們沒有聽到這些。唯一的——再說一次，在我所有的談話中，它只涉及報銷問題。

So that's actually a good thing, because we can solve that, right? It takes time to solve that. But once we start getting explanation of benefits, EOVs out there, once they start to see what we're hearing from a lot of the practices, is, okay, I'll try it on one patient. They typically want it to be a Medicare fee-for-service patient, because that's kind of the one that they feel most confident about.

所以這其實是一件好事，因為我們可以解決這個問題，對吧？解決這個問題需要時間。但是，一旦我們開始了解其益處，一旦 EOV 開始了解我們從許多實踐中聽到的內容，那麼，好吧，我會在患者身上嘗試。他們通常希望患者是按服務收費的醫療保險患者，因為這是他們最有信心的。

And then once they get that experience and see a positive reimbursement, then they're more willing to expand beyond to other patients. But I think, again, without speculating on the number, it would be significantly more. There's no doubt about it.

一旦他們獲得了這種經驗並看到了積極的報銷，他們就更願意擴展到其他患者。但我再次認為，無需猜測具體數字，實際數字會大得多。毫無疑問。

And I think the good news is when you're out there talking to doctors, that's the question. It's really around reimbursement and not around the clinical usage or utility or need for this drug. And I think that's a very good place for us to be.

我認為好消息是，當你與醫生交談時，這就是問題所在。這實際上與報銷有關，而不是與該藥物的臨床使用或效用或需求有關。我認為這對我們來說是一個非常好的處境。

When do you think you'd be able to provide short-term and long-term guidance for ZUSDURI? And just trying to -- I know that we're talking about the story being overall targeting $5 billion market, but we're also trying to understand what would be the peak sales. Just wanted to understand the level of comfort to provide a both short-term and long-term guidance for the drug.

您認為何時能夠為 ZUSDURI 提供短期和長期指導？只是想——我知道我們正在談論的是針對 50 億美元市場的總體目標，但我們也試圖了解銷售高峰是多少。只是想了解舒適度水平，以便為該藥物提供短期和長期指導。

Yeah. Aydin, this is Chris. I mean I think we've been pretty clear in terms of peak potential. We view ZUSDURI as over $1 billion opportunity by itself. In terms of providing more short-term guidance, I think we'll get through the early initial launch phase this year and look to potentially provide guidance for 2026.

是的。艾丁，這是克里斯。我的意思是，我認為我們在峰值潛力方面已經非常清楚了。我們認為 ZUSDURI 本身就蘊藏著超過 10 億美元的商機。在提供更多短期指導方面，我認為我們將在今年完成早期啟動階段，並有望為 2026 年提供指導。

Okay. Thanks so much.

好的。非常感謝。

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

問答環節到此結束。現在我想請莉茲·巴雷特作最後發言。

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

是的。我只是想藉此機會向大家表示感謝。感謝您多年來的陪伴。對我們來說這是一個令人興奮的時刻。我們仍處於早期階段，但一切看起來都很順利，我們對目前的狀況和未來的發展方向感到非常興奮。我們會及時向大家通報事情的進展。非常感謝。我們對此表示感謝。

Operator, you can disconnect at this moment. Thank you.

接線員，您現在可以掛斷電話了。謝謝。

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

感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。