Urogen Pharma Ltd (URGN) 2024 Q3 法說會逐字稿

Good morning. Ladies and gentlemen. Thank you for standing by and welcome to the Urogen Pharma Ltd third quarter, 2024 earnings call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today. Vincent Perrone, head of investor relations. You may now begin.

早安.女士們，先生們。感謝您的支持，歡迎參加 Urogen Pharma Ltd 2024 年第三季財報電話會議。請注意，今天的會議正在錄音。現在，我想將會議移交給今天的發言人。投資者關係主管 Vincent Perrone。現在您就可以開始了。

Thank you, operator. Good morning, everyone and welcome to Urogen Pharma Ltd third quarter, 2024 financial results and business update conference call.

謝謝您，接線生。大家早安，歡迎參加 Urogen Pharma Ltd 2024 年第三季財務業績和業務更新電話會議。

Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended. September 30, 2024.

今天早些時候，我們發布了一份新聞稿，概述了我們近期的公司亮點和本季的財務表現。2024 年 9 月 30 日。

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

您可在我們網站的投資者部分（地址為 investor.Urogen.com）上查閱該新聞稿。

Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Mark P. Schoenberg, M.D., 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、醫學博士 Mark P. Schoenberg、首席醫療官 David Lin、首席商務官和財務長 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 gel mino, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations as well as future commercialization activities for UGN 102 if approved anticipated data regulatory filings and decisions. UGN 102 being the growth driver for EUR and for pro future R&D efforts are corporate goals and 2024 financial guidance. Among other things, these forward-looking statements are based on current information, assumptions and expectations that are subject to change. The description of potential risks can be found in our earnings press release and latest sec disclosure documents, your caution not to place undue reliance on these forward-looking statements and your agenda claims any obligation to update these statements.

在今天的電話會議中，我們將做出某些前瞻性的陳述。這些可能包括有關我們正在進行的與 gel mino 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、我們的商業化戰略和預期以及 UGN 102 的未來商業化活動（如果預期的數據監管備案和決定獲得批准）的聲明。UGN 102 是歐元區的成長動力，也是未來研發工作的動力，是企業目標和 2024 年的財務指導。除其他事項外，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。有關潛在風險的描述可參閱我們的收益新聞稿和最新的證券交易委員會披露文件，請注意不要過分依賴這些前瞻性陳述，並且本公司不承擔更新這些陳述的任何義務。

I'll now turn the call over to Liz Barrett.

現在我將電話轉給利茲·巴雷特。

Thank you, Vincent and thank you for joining us this morning as we continue to innovate and pioneer new treatment paradigms in urothelial cancers. I'm excited to highlight the progress we've made with UGN 102, our groundbreaking therapy for low grade intermediate risk, non-muscle invasive bladder cancer. Ahead of schedule, we successfully submitted the new drug application for U GM 102 in August and in October, we are, we were pleased to announce the FDA S acceptance of the ND A with the PDUFA target date of June 13th, 2025. This milestone represents more than a regulatory achievement is a testament to the dedication of our team and a pivotal step toward our goal of changing how low-grade intermediate risk, non-muscle invasive bladder cancer is treated.

謝謝你，文森特，謝謝你今天早上加入我們，我們將繼續創新和開拓尿路上皮癌的新治療模式。我很高興地強調我們在 UGN 102 方面取得的進展，這是我們針對低度中度風險、非肌肉層浸潤性膀胱癌的突破性療法。我們提前於 8 月成功提交了 U GM 102 的新藥申請，10 月，我們很高興地宣布 FDA 接受了該 ND A，PDUFA 目標日期為 2025 年 6 月 13 日。這個里程碑不僅代表著一項監管成就，也證明了我們團隊的奉獻精神，也是朝著改變低度中度風險、非肌肉層浸潤性膀胱癌治療方式的目標邁出的關鍵一步。

Our regulatory and clinical teams are committed to working closely with the FDA during the review process as we move toward a potential approval. Meanwhile, we are initiating our pre commercial activities to position ourselves for a robust launch with the ability to deliver UGN 102 to patients. At the earliest opportunity, David will provide more details on this shortly.

我們的監管和臨床團隊致力於在審查過程中與 FDA 密切合作，以獲得可能的批准。同時，我們正在啟動商業化前的活動，為強勁推出 UGN 102 做好準備，並有能力將 UGN 102 提供給患者。David 將盡快提供有關此事的更多詳細資訊。

If approved U GM 102 will become the first FDA approved medicine for this patient population. Introducing a novel solution that could significantly reduce recurrent rates while extending the time between treatments.

如果獲得批准，U GM 102 將成為 FDA 批准的首個針對該患者群體的藥物。介紹一種新穎的解決方案，可以顯著降低復發率，同時延長治療間隔。

Em one or two aligns with our commitment to enhancing patient outcomes and reshaping treatment paradigms in neurologic oncology, the market opportunity for U GM 102 has the potential to be transformative for our company with more than 80,000 addressable patients annually in the US. This market is approximately 10 times larger than the market. JDO currently serves and represents an estimated total addressable market of over $5 billion.

Em one 或 two 與我們致力於改善患者治療效果和重塑神經腫瘤學治療模式的承諾相一致，U GM 102 的市場機會有可能為我們公司帶來變革，我們公司每年在美國有超過 80,000 名可治療的患者。這個市場大約比這個市場大10倍。JDO 目前服務並代表預計總目標市場超過 50 億美元。

In contrast to the Gia mito market opportunity and low grade upper tracheal celial carcinoma, which is a rare disease which is dispersed and episodic. Low grade intermediate risk on invasive bladder cancer is widespread and regularly managed by nearly all urologists.

與Gia mito市場機會和低度上氣管癌相比，低度上氣管癌是一種分散、偶發的罕見疾病。低度中度風險的侵襲性膀胱癌很普遍，幾乎所有泌尿科醫師都會定期治療。

UGN 102 is straightforward to administer and integrate seamlessly into existing outpatient practice workflows without the need for special equipment.

UGN 102 管理簡單，可無縫整合到現有的門診實務工作流程中，無需特殊設備。

Domier delivered $25.2 million in net product revenue for the third quarter, representing a 21% year over year increase the revenue reflected strong underlying patient demand but also included $2.6 million from create a sale in Q3 of 2024 compared to $1.1 million in the same period in 2023.

Domier 第三季的淨產品收入為 2,520 萬美元，年增 21%，該收入反映了強勁的潛在患者需求，但也包括 2024 年第三季的 260 萬美元銷售收入，而 2023 年同期為 110 萬美元。

Recognizing the high touch nature of this product, we strategically focused on increasing our reach and frequency with key accounts in the quarter, which we believe is contributing to improved demand growth in the third quarter compared to the first half of this year. In fact, new patient enrollments in Q3 increased over 30% versus prior year representing an all-time high since launch. Similarly, we continue to drive a healthy increase in new prescribers up over 30% versus a year ago.

認識到該產品的高接觸性質，我們在本季度策略性地專注於增加與主要客戶的覆蓋面和頻率，我們相信這有助於第三季度的需求增長相對於今年上半年有所改善。事實上，第三季新病患登記數量比去年同期增加了 30% 以上，創下了自推出以來的歷史新高。同樣，我們繼續推動新處方數量與一年前相比健康增加 30% 以上。

We are seeing signs of continued momentum in early Q4 and expect to be able to deliver low double digit revenue growth for JDO for the full year 2024. Despite the gross to net headwinds, we variance in recent quarters.

我們看到第四季初持續成長的跡象，預計 2024 年全年 JDO 的營收將達到低兩位數成長。儘管總淨利潤存在不利因素，但最近幾季我們仍出現了差異。

Looking ahead at the core of Eig's life cycle management strategy is ensuring the long-term success and growth of our EUR oncology franchise in September, we announced receipt of a notice of allowance from the US patent and trademark office for a patent covering key technology used in the development of UGN 103 and UGN 104. Our next generation therapies for U GM 102 and JMI respectively.

展望未來，Eig 的生命週期管理策略的核心是確保我們 EUR 腫瘤學特許經營的長期成功和成長。我們的下一代療法分別針對 U GM 102 和 JMI。

Upon issuance, the patent will extend through December of 2041 and cover the innovative combination of our proprietary RT gel technology with a unique mitomycin formulation licensed from Medac.

專利發布後將延長至 2041 年 12 月，涵蓋我們專有的 RT 凝膠技術與 Medac 授權的獨特絲裂黴素配方的創新組合。

This is a critical step in strengthening our intellectual property portfolio and providing life cycle management that extends our franchise for the long-term dosing in the phase three Utopia trial for E GM 103 commenced in early October demonstrating continued minim momentum in our clinical development mark will provide further details on this exciting progress.

這是加強我們的智慧財產權組合和提供生命週期管理的關鍵一步，它擴大了我們在 10 月初開始的 E GM 103 第三階段 Utopia 試驗中的長期用藥特許經營權，表明我們的臨床開發勢頭持續強勁，並將提供有關這一激動人心的進展的更多詳細信息。

In October, we appointed Chris Degnan as Chief Financial Officer. Chris has extensive CFO experience with publicly traded biotech companies most recently at Galera Therapeutics and Verica Pharmaceuticals. He has also held senior positions at Indo International and worked at AstraZeneca for more than 10 years. He has broad expertise in financial strategy, investor relations, sec reporting, accounting and compliance. I want to take this opportunity to formally welcome origin. He is joining us on the call today and will provide financial results for the quarter shortly.

十月份，我們任命 Chris Degnan 為財務長。Chris 擁有在上市生物科技公司擔任財務長的豐富經驗，最近在 Galera Therapeutics 和 Verica Pharmaceuticals 擔任財務長。他也曾在Indo International擔任高階職位，並在阿斯特捷利康工作了10多年。他在財務策略、投資者關係、證券報告、會計和合規方面擁有豐富的專業知識。我想藉此機會正式歡迎 Origin。他將參加今天的電話會議，並將很快提供本季的財務表現。

Chris' appointment is part of the broader initiative to enhance our leadership team as we prepare to commercialize Eugen N 102 and take Egen to the next stage of growth. We also welcome David Lynn as our new Chief Commercial Officer in June. I will now turn the call over to Mark P. Schoenberg, M.D. our Chief Medical Officer for a clinical update. Mark.

克里斯的任命是我們加強領導團隊的更廣泛舉措的一部分，我們正準備將 Eugen N 102 商業化，並將 Egen 帶入下一階段的發展。我們也將於六月歡迎 David Lynn 擔任我們的新任商務長。現在，我將把電話轉給我們的首席醫療官 Mark P. Schoenberg 博士，以了解臨床最新情況。標記。

Thank you, Liz. I want to begin by echoing Liz's sentiments regarding the FDA S acceptance of our ND A for UGN 102. This is a significant milestone for our company. Our regulatory and clinical teams look forward to collaborating closely with the agency throughout our review process.

謝謝你，莉茲。首先，我想同意 Liz 對 FDA 接受我們的 UGN 102 ND A 的看法。這對我們公司來說是一個重要的里程碑。我們的監管和臨床團隊期待在整個審查過程中與該機構密切合作。

The UN 102 ND A is supported by a robust and comprehensive development program that demonstrated a clinically meaningful complete response rate and a strong duration of response across three late phase clinical trials. Along with an acceptable safety profile. The phase three envision trial which serves as the pivotal trial for the ND A successfully met its primary endpoint demonstrating a 79.6% complete response rate at three months after the first installation of UN 102.

UN 102 ND A 得到了強大而全面的開發計劃的支持，該計劃在三個後期臨床試驗中證明了具有臨床意義的完全緩解率和強勁的反應持續時間。具有可接受的安全性。作為 ND A 關鍵試驗的第三階段設想試驗成功達到了其主要終點，即在首次安裝 UN 102 後三個月的完全緩解率為 79.6%。

More recently, durability data from envision revealed an impressive 82.3% 12 month duration of response by capital Myer analysis in patients who had achieved a complete response of three months. Notably, this represents the highest duration of response ever reported in this patient population.

最近，Envision 的耐久性數據顯示，Capital Myer 分析顯示，對於已達到三個月完全緩解的患者，12 個月的緩解持續時間高達 82.3%。值得注意的是，這是該患者群體有史以來報告的最長反應持續時間。

I am also pleased to report that the long-term durability data from the Envision trial were recently published online in the journal of urology. The article will appear in print early next year as we have communicated, we are anticipating an advisory committee and are proactively preparing for this meeting. The FDA has not notified us of the timing, but we expect to receive notification early in 2025. If approved, we believe UGN 102 will represent a significant advancement in the treatment of low-grade intermediate risk, non-muscle invasive bladder cancer.

我還很高興地報告，Envision 試驗的長期耐久性數據最近在泌尿學雜誌上在線發表。正如我們所溝通的那樣，該文章將在明年初出版，我們期待一個諮詢委員會的成立，並正在積極為這次會議做準備。FDA 尚未通知我們具體時間，但我們預計將在 2025 年初收到通知。如果獲得批准，我們相信 UGN 102 將代表低度中度風險、非肌肉層浸潤性膀胱癌治療的重大進步。

Turning now to the pipeline, as Liz mentioned, we have a comprehensive life cycle management plan for gel mito and UGN one and two. In October, we announced the dosing of the first patient in the phase three clinical trial, evaluating UN one and three for the treatment of low-grade intermediate risk, non-muscle invasive bladder cancer. Utopia trial is a single arm phase three multi-center study designed to evaluate the efficacy and safety of UGN 103. Our goal is to enroll 87 patients. The study protocol mirrors that of the envision trial with low grade intermediate risk NM I BC patients with recurrent disease receiving UGN 103 via intravesical installation. Once a week for six weeks, efficacy will be assessed based on the complete response rate at the three-month mark. Patients achieving a complete response defined as having no detectable disease in the bladder. At this visit, we enter a follow up period during which they will return to the clinic every three months for ongoing evaluation of duration of response. We anticipate filing the new drug application with the FDA in 2026 and if approved the commercial launch in 2027 we foresee a similar development plan for UGN 104. Our next generation formulation of gel Mito and expect to commence a single arm phase three study early next year.

現在談到管道，正如 Liz 所提到的，我們針對 gel mito 和 UGN 一號和二號制定了全面的生命週期管理計劃。在十月份，我們宣布了第三階段臨床試驗第一位患者的給藥，該試驗評估了 UN 一號和三號藥物治療低度中度風險、非肌肉層浸潤性膀胱癌的效果。Utopia 試驗是一項單組三期多中心研究，旨在評估 UGN 103 的療效和安全性。我們的目標是招募 87 名患者。此研究方案與設想試驗相似，即對患有復發性疾病的低度中度風險 NM I BC 患者透過膀胱內植入接受 UGN 103 治療。每週一次，持續六週，根據三個月時的完全緩解率來評估療效。達到完全緩解的患者定義為膀胱中沒有可檢測到的疾病。這次訪問後，我們進入追蹤期，在此期間他們將每三個月返回診所，持續評估反應持續時間。我們預計將於 2026 年向 FDA 提交新藥申請，如果 2027 年批准商業發布，我們預計 UGN 104 也會有類似的開發計畫。我們的下一代凝膠 Mito 配方預計將於明年初開始單臂第三階段研究。

Turning to our high-grade bladder cancer pipeline. We continue to develop our immune oncology candidate U GM 301; U GM 301 is an anti CTL A four antibody delivered using our proprietary RT GL technology. We are conducting a phase one clinical study to evaluate safety tolerability and to establish a recommended phase two dose for UGN 301.

轉向我們的高等級膀胱癌管線。我們繼續開發我們的免疫腫瘤候選藥物 U GM 301； U GM 301 是一種抗 CTL A 四抗體，採用我們專有的 RT GL 技術遞送。我們正在進行第一階段臨床研究，以評估安全耐受性並確定 UGN 301 的第二階段建議劑量。

We will present an update of our UGN 301 program at the upcoming Society of Neurologic Oncology meeting scheduled for December 4 through six in Dallas. Additional abstracts were accepted for poster presentation including the envision duration of response data and long term follow up results from the gel Mito Olympus trial. This year's meeting promises to be particularly productive for our team and now over to David Lin for a commercial update, David.

我們將在 12 月 4 日至 6 日在達拉斯舉行的神經腫瘤學會會議上介紹我們的 UGN 301 計劃的最新進展。海報展示的其他摘要也被接受，其中包括凝膠 Mito Olympus 試驗的預期反應持續時間數據和長期追蹤結果。今年的會議對我們的團隊來說肯定是特別有成效的，現在請 David Lin 來介紹商業動態，David。

Thank you, Mark Good morning, everyone.

謝謝，馬克，大家早安。

As we focus on the journey ahead with UGN 102, my top priority continues to be preparing Erigena for an anticipated commercial launch in 2025 with the target PDUFA date of June 13th, 2025. Now established, we have a clear timeline for potential approval and launch our immediate priority is executing a robust pre commercial strategy that will establish a solid foundation for making un one and two accessible to the medical community and driving widespread adoption.

當我們專注於 UGN 102 的未來發展時，我的首要任務仍然是為 Erigena 做好準備，預計該藥物將於 2025 年進行商業發布，目標 PDUFA 日期為 2025 年 6 月 13 日。現在，我們已經制定了明確的潛在批准和發佈時間表，我們的當務之急是執行強有力的商業化前策略，為聯合國一號和二號能夠被醫學界使用並推動廣泛採用奠定堅實的基礎。

We are confident in the strength of our clinical data and the transformative opportunity. It presents to enhance outcomes for patients with low grade intermediate risk, non-muscle invasive bladder cancer.

我們對我們的臨床數據的實力和變革機會充滿信心。它旨在提高低度中度風險、非肌肉浸潤性膀胱癌患者的治療效果。

The launch of UGN 102 would mark Eig's evolution from a rare disease focused organization to a specialty focused multi product team.

UGN 102 的推出標誌著 Eig 從一個專注於罕見疾病的組織轉變為專注於專業的多產品團隊。

We are scaling our commercial capabilities including patient support and distribution infrastructure.

我們正在擴大我們的商業能力，包括患者支援和分銷基礎設施。

Importantly, we plan to expand our sales force from approximately 42 reps to over 80 at launch a significant factor in our decision to expand our sales force stems from our learnings and experiences with gel Mido.

重要的是，我們計劃將銷售隊伍從大約 42 名代表擴大到 80 多名代表，我們決定擴大銷售團隊的一個重要因素源於我們在 Gel Mido 方面的經驗和教訓。

We have learned that more engagement from our sales and support teams leads to more effective responses from clinical practices.

我們了解到，銷售和支援團隊的更多參與會帶來更有效的臨床實務反應。

To that end, we are committed to having an appropriately sized field force in place by the launch of N 102.

為此，我們致力於在 N 102 發射時部署適當規模的實地部隊。

Our updated launch plan is designed to significantly increase the frequency of interactions with targeted physicians ensuring we maximize our impact in the market.

我們更新的發布計劃旨在大幅增加與目標醫生的互動頻率，確保我們最大限度地發揮在市場上的影響力。

At the same time, we are actively advancing our pre-launch activities for UGN 102.

同時，我們正在積極推進UGN 102的發布前活動。

Our focus includes education through various programs aimed at raising awareness of the unmet need in low grade intermediate risk, non-muscle invasive bladder cancer. While our medical affairs team is also sharing our clinical data to appropriately communicate the value proposition ahead of approval to facilitate the integration of UGN 102 into treatment protocols. We will provide comprehensive support including training for health care professionals and their office staff.

我們的重點包括透過各種計畫進行教育，旨在提高人們對低度中度風險、非肌肉層浸潤性膀胱癌未滿足需求的認識。同時我們的醫療事務團隊也在分享我們的臨床數據，以便在批准之前適當地傳達價值主張，以促進 UGN 102 融入治療方案中。我們將提供全面支持，包括對醫療保健專業人員及其辦公室工作人員的培訓。

Additionally, we are implementing engagement initiatives to inform both clinical practices and patients about UGN 102 S coverage options and reimbursement.

此外，我們正在實施參與計劃，向臨床實踐和患者介紹 UGN 102 S 承保選項和報銷情況。

It's important to note that upon approval, UGN 102 will initially be assigned a miscellaneous J code for billing which is standard for new drugs based on the June 2025 PDUFA date. We would expect to secure a unique permanent J code for Eugene 102 by January 2026.

值得注意的是，獲得批准後，UGN 102 將首先被分配一個雜項 J 代碼用於計費，這是根據 2025 年 6 月 PDUFA 日期制定的新藥標準。我們預計將於 2026 年 1 月為 Eugene 102 獲得唯一的永久 J 代碼。

While a miscellaneous J code may pose fewer challenges for hospitals and oncology centers. The permanent J code is particularly important in the community setting.

而雜項 J 代碼可能對醫院和腫瘤中心帶來的挑戰較少。永久 J 代碼在社區環境中尤其重要。

Throughout this period, we are fully committed to offering robust reimbursement support to help providers navigate the interim coding process smoothly, ensuring integration of UGN 102 is seamless.

在此期間，我們全力致力於提供強大的報銷支持，以幫助供應商順利完成臨時編碼流程，確保 UGN 102 的無縫整合。

I will now turn the call over to Chris Degnan to discuss our financials.

現在我將把電話轉給克里斯·德格南 (Chris Degnan) 討論我們的財務狀況。

Thank you, David and good morning, everyone before I get into the financials, I would first like to take a moment to say that I'm thrilled to join Urine at such a pivotal time for the company, the strength of our pipeline and the significant market opportunities ahead, present a unique moment for growth and innovation.

謝謝，大衛，大家早上好，在介紹財務情況之前，我首先想花點時間說一下，我很高興在公司如此關鍵的時刻加入 Urine，我們強大的產品線和未來巨大的市場機遇，為公司的增長和創新提供了一個獨特的時刻。

I'm excited to work with the talented team that we have here to help bring our transformative therapies to patients and drive long term value for our shareholders.

我很高興能與我們優秀的團隊合作，幫助為患者帶來變革性的療法，並為我們的股東創造長期價值。

Turning now to the quarter, as Liz mentioned, do Mito net product revenues reached $25.2 million in the third quarter of 2024 compared to $20.9 million for the same period. In 2023 primarily driven by strong underlying demand growth.

現在談到本季度，正如 Liz 所提到的，Mito 的淨產品收入在 2024 年第三季達到 2,520 萬美元，而同期為 2,090 萬美元。2023 年主要由強勁的潛在需求成長所推動。

Our focus efforts to increase our reach and frequency with key accounts generated solid momentum which positively impacted Q3 results.

我們專注於努力提高對重點客戶的覆蓋率和頻率，產生了強勁勢頭，對第三季的業績產生了積極影響。

Volume growth was partially offset by continued year over year gross to net erosion due in part to the Medicare WTES provision and growing 340 B utilization.

銷售成長被持續的同比毛利與淨利下滑部分抵消，部分原因是由於 Medicare WTES 條款和 340 B 使用率的不斷增長。

The overall gross to net rate for Del Mio was relatively consistent quarter over quarter cost of revenue in the third quarter was $2.5 million compared with $2.4 million for the comparable period. In 2023 the slight increase was primarily attributable to the increased volume of sales of jo Mito partially offset by certain non-recurring payments made in connection with our supply arrangement in the prior year.

Del Mio 的整體毛淨利率與上一季相比相對穩定，第三季的收入成本為 250 萬美元，而去年同期為 240 萬美元。2023 年的小幅成長主要歸因於 jo Mito 的銷售量增加，但部分被上一年度與我們供應安排相關的某些非經常性付款所抵消。

Research and development expenses in the third quarter were $11.4 million compared with $10.2 million for the comparable quarter. In 2023 the increase year over year was primarily attributable to higher costs related to the initiation of the phase three Utopia trial for UGN 103 partially offset by lower UGN 102 clinical trial costs and costs related to the research into ingredients. Scale up and production efficiency for gel Mito selling general and administrative expenses for the third quarter of 2024 were $28.9 million including non-cash share based compensation expense of $2.9 million. This compares to $21.8 million including non cash share based compensation expense of $1.8 million. For the same period. In 2023 the year over year increase was primarily driven by UN one or two pre commercialization activities.

第三季研發費用為 1,140 萬美元，去年同期為 1,020 萬美元。2023 年同比增長主要歸因於啟動 UGN 103 第三階段 Utopia 試驗相關的成本增加，但 UGN 102 臨床試驗成本降低以及與成分研究相關的成本部分抵消了這一影響。2024 年第三季凝膠 Mito 銷售一般及行政費用的擴大和生產效率為 2,890 萬美元，其中包括 290 萬美元的非現金股權激勵費用。相比之下，其中包括 180 萬美元的非現金股權薪酬費用，而淨利潤為 2,180 萬美元。同一時期。2023 年的年增率主要得益於聯合國一或二期商業化預活動。

We reported noncash financing expense of $5.9 million in the third quarter relating to the prepaid forward obligation to RT W investments.

我們報告第三季的非現金融資費用為 590 萬美元，與預付 RT W 投資的長期債務有關。

This compares with $5.5 million in the comparable period. In 2023 the increase of $0.4 million was driven primarily by changes in underlying assumptions for remeasuring the effective rate interest expense related to the $125 million term loan facility with Pharmakon advisors was $2.7 million in the third quarter compared with $3.8 million for the comparable period. In 2023 the decrease was primarily attributable to the decrease in the margin interest rate and the related impact to amortization of the discount on the Pharmakon loan. As a result of the amended and restated loan agreement in March 2024.

相比之下，同期這一數字為 550 萬美元。2023 年增加 40 萬美元，主要由於重新計量有效利率的基本假設的變化，與 Pharmakon 顧問達成的 1.25 億美元定期貸款相關的利息費用在第三季度為 270 萬美元，而去年同期為 380 萬美元。2023 年的下降主要歸因於保證金利率的下降以及對 Pharmakon 貸款折扣攤銷的相關影響。這是2024年3月修改重述的貸款協議的結果。

The third tranche of $25 million under the amended and restated loan agreement was funded in late September 2024.

根據修訂和重述的貸款協議，第三筆 2500 萬美元的資金將於 2024 年 9 月下旬撥付。

Net loss for the third quarter was $23.7 million or 55¢ per basic and diluted ordinary share as compared to a net loss of $21.9 million or 68¢ per basic and diluted share in the same period in 2023 as of September 30 2024 we had $254.2 million in cash and cash equivalents and marketable securities with our fortified balance sheet. We believe we have the requisite cash and capital to execute our business objectives.

第三季的淨虧損為 2,370 萬美元，即每股基本和稀釋普通股 55 美分，而 2023 年同期的淨虧損為 2,190 萬美元，即每股基本和稀釋每股 68 美分。 截至 2024 年 9 月 30 日，我們的現金和資產等價物以及資產負債表穩健證券為 2.54 億美元，資產負債表穩健我們相信我們擁有實現業務目標所需的現金和資本。

Turning to forward guidance.

轉向前瞻性指引。

Although we saw strong underlying demand in the quarter, we expect full year gel Mito revenues to fall below the low end of our previous guidance. However, we do believe that gel Mito will deliver low double digit revenue growth for the full year despite the higher than expected gross to net headwinds in recent quarters.

儘管我們看到本季強勁的潛在需求，但我們預計全年凝膠 Mito 收入將低於我們先前預期的低端。不過，儘管最近幾季的毛利與淨利逆風高於預期，但我們確實相信，Gel Mito 全年營收將實現低兩位數成長。

Regarding 2024 full year operating expense guidance, we now expect operating expenses to be near the midpoint of our previously guided range of 175 to $185 million including non-cash share based compensation expense of 9 to $13 million.

關於 2024 年全年營運費用指引，我們現在預計營運費用將接近我們先前指引的 1.75 億至 1.85 億美元的中點，其中包括 900 萬至 1,300 萬美元的非現金股權激勵費用。

This outlook reflects the shift in timing of expenditures tied to the PDUFA target date and preparations for the potential commercial launch of UN 102.

這一前景反映了與 PDUFA 目標日期相關的支出時間的變化以及為 UN 102 的潛在商業發布所做的準備。

The anticipated full year 2024 noncash financing expense related to the prepaid obligation to RT W investments is unchanged and expected to be in the range of 21 to $26 million.

與 RT W 投資預付款相關的預計 2024 年全年非現金融資費用保持不變，預計在 2,100 萬至 2,600 萬美元之間。

The rate for the cash component of the RT W obligation will be 13% of global net product sales of Gel Mido. In 2024 we're now ready to open the call for questions, operator.

RT W 義務的現金部分的比率將為 Gel Mido 全球淨產品銷售額的 13%。2024 年，我們現在準備開始回答問題了，接線生。

Thank you. At this time, we will conduct the question-and-answer session as a reminder to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced to withdraw a question. Please press star 11 again. Please stand by while we compile the Q&A roster.

謝謝。此時，我們將進行問答環節，作為提醒您提問，您需要在電話上按下星號 11 並等待宣布您的名字以撤回問題。請再按一次星號 11。請稍候，我們正在編制問答名單。

Our first question comes from the line of Tara Bancroft with TD Cohen. Your line is now open.

我們的第一個問題來自 TD Cohen 的 Tara Bancroft。您的線路現已開通。

Hi and good morning. First of all, congrats on the ND A acceptance, it's really great to see and I was wondering if you received and, and got any more clarity from the 72 day letter in in writing perhaps on why the decision was made for standard review or you know, aside from the letter, do you have any other insight into that based on your interactions? Thanks.

嗨，早安。首先，恭喜您獲得 ND A 的認可，這真的很高興，我想知道您是否收到了這封 72 天的書面信函，並且對為什麼做出標準審查的決定有了更清晰的了解，或者除了這封信之外，根據您的互動，您是否還有其他見解？謝謝。

Yeah, thanks, Tara. They didn't say anything about priority review in the in the letter they just talked about obviously, the review questions, you know, which are does envision, you know, provide enough data for, you know, to demonstrate efficacy. You know, what's the role of Atlas and you know, overall, you know that is a profile, you know, acceptable. So kind of the typical, what you expect the, the FDA to say at this point in time, we do know from just from correspondence with them and in our initial meeting where we had did the application review that they had not at that point in time, actually reviewed our, our, our data, we know they reviewed the, the, the portions that we sent in back in January, the non-clinical, but they had not yet reviewed the clinical portion. So, look, we can sit here and guess as to why, you know, my view on it, obviously, the prior to review would have put them against the wall from a timing standpoint. And you know, the, the argument has always been, well, they can go back to surgery, and we don't think that's a great argument. We, we act actually very much believed that we qualified for priority review, but obviously they saw it differently. So, and I think the other thing is we've consistently said that we expect an ODAC. And so, I think again, from a timing perspective, had we gotten priority review? It would have been, I think a very short period of time for them to prepare. So that's the only the only sort of, you know, guess we have but, but nothing, you know, they didn't, they, they didn't even acknowledge one way or the other, the priority versus standard review. Just gave us our timing and then gave us the here are your potential you know, review issues and with the three that I mentioned.

是的，謝謝，塔拉。他們在信中沒有提到優先審查，顯然他們剛才談到的審查問題確實設想提供足夠的數據來證明療效。你知道 Atlas 的作用是什麼，總的來說，這是一個可以接受的概況。因此，您期望 FDA 此時會說什麼，我們從與他們的通信中以及在我們進行申請審查的初次會議上確實知道，他們當時尚未實際審查我們的數據，我們知道他們審查了我們在一月份發送的非臨床部分，但他們尚未審查臨床部分。所以，看，我們可以坐在這裡猜測為什麼，你知道，我的觀點是，顯然，從時間的角度來看，事先的審查會讓他們陷入困境。你知道，爭論的焦點一直是，他們可以重新進行手術，而我們認為這不是一個很好的論點。我們實際上非常相信我們有資格獲得優先審查，但顯然他們有不同的看法。所以，我認為另一件事是我們一直表示我們期待 ODAC。因此，我再次思考，從時間角度來看，我們是否獲得了優先審查？我認為，對他們來說，這段準備時間非常短。所以這是唯一的一種，你知道，猜猜我們有，但是，但是什麼都沒有，你知道，他們甚至沒有承認優先順序與標準審查之間的區別。只是告訴我們時間安排，然後告訴我們潛在的審查問題以及我提到的三個問題。

Okay, great. Yeah, that makes a lot of sense. Thanks so much.

好的，太好了。是的，這很有道理。非常感謝。

Thanks Sarah.

謝謝莎拉。

Thank you. Our next question comes from the line of Ram Selvaraju with HC Wainwright and co your line is now open.

謝謝。我們的下一個問題來自 HC Wainwright 和同事 Ram Selvaraju，您的熱線現已開通。

Thanks very much for taking my questions. Firstly, I was wondering if you could elaborate on a couple of commercial points, particularly the gross to net discounting with respect to Jo Mido. And why you expect that not to be a factor for eg 102?

非常感謝您回答我的問題。首先，我想知道您是否可以詳細說明幾個商業要點，特別是關於 Jo Mido 的毛利與淨利折扣。並且為什麼您認為這不會成為例如 102 的一個因素？

Sure, Chris. You want to take that?

當然，克里斯。你想拿走那個嗎？

Sure. So the two big headwinds we've been seeing on gross and net one is 340 B and the second is the Medicare waste is provision. With respect to 102, we don't expect the waste is provision to apply just given you know, the yield loss that we see with the mixing of Joe Mito and the size of the kidney relative to be able to use the, the full dose within the bladder. And then from a 340 B pricing perspective, we do expect more utilization over time in the community setting, which should mitigate some of the 340 B exposure that we're seeing with gel.

當然。因此，我們在總收入和淨收入方面看到的兩個大阻力是，一是 3,400 億美元，二是醫療保險浪費。對於 102，我們不希望浪費的規定適用，只是考慮到我們看到的 Joe Mito 混合造成的產量損失以及腎臟的大小相對於能夠在膀胱內使用全劑量。然後從 340 B 定價的角度來看，我們確實預計隨著時間的推移，社區環境中的利用率會更高，這應該會減輕我們在凝膠中看到的一些 340 B 暴露。

And then with respect to the commercial preparations for UGN 102. Can you maybe give us a sense of how the timeline might have shifted with respect to the receipt of standard review for the 102 ND A application. And when you expect to incept specific pre-launch activities as you approach the PDUFA date.

然後是關於 UGN 102 的商業準備。您能否向我們介紹一下，102 ND A 申請的標準審查時間表可能發生了哪些變化。當您接近 PDUFA 日期時，您預計會開始特定的發布前活動。

Maybe.

或許。

Yeah. Hi, this is David. The standard review doesn't change consequentially any of the major things we're doing in terms of pre-launch education. As we mentioned, our top priority right now is from an organization standpoint is to educate on the unmet need in non-muscle invasive low grade intermediate bladder cancer. And our medical teams continue to share the clinical data with providers in the field of neuro oncology. So, otherwise, the preparations remain largely intact, which is preparing our infrastructure and our distribution networks to take on a new product that is considerably larger. And as we mentioned, we will be increasing the size of our field team by about two weeks, by the time we launch UGN 102.

是的。你好，我是大衛。標準審查不會對我們在發布前教育方面所做的任何重大工作產生重大改變。正如我們所提到的，從組織的角度來看，我們現在的首要任務是教育人們關注非肌肉層浸潤性低度中期膀胱癌的未滿足需求。我們的醫療團隊繼續與神經腫瘤學領域的供應商分享臨床數據。因此，除此之外，準備工作基本上完好無損，即為我們的基礎設施和分銷網絡做好迎接更大規模的新產品的準備。正如我們所提到的，在啟動 UGN 102 時，我們的現場團隊規模將增加約兩週。

Okay. And then just two very quick additional questions. Firstly, I was wondering if you could comment on the timing with which you expect office action on the patent covering the patent application covering the Medac formulation of mitomycin that Liz you mentioned in your prepared remarks and also maybe mark, I don't know if you want to comment at this time on what you anticipate the composition of the future Adcom panel to be just on a qualitative basis. But if you had any insights there, that would be much appreciated. Thank.

好的。然後還有兩個非常簡單的附加問題。首先，我想知道您是否可以評論一下您預計對涵蓋絲裂黴素 Medac 配方的專利申請的專利採取審查行動的時間，Liz 您在準備好的評論中提到了這一點，也許還有 Mark，我不知道您是否想在此時僅從定性角度評論一下您對未來 Adcom 小組的組成預期。但如果您有任何見解，我們將非常感激。感謝。

You. Why don't you go ahead and mark and then, yeah.

你。為什麼不繼續做標記然後呢，是的。

Thanks. So, I think the short answer is, well, I don't know the composition. My, my suspicion would be that it would be reflective of other atoms, particularly reflected by you know, the evaluation of other drugs in space. So, we'd expect some urologists, particularly neurologic oncologists would expect that we experience in treating this disease surgically. But I imagine there will also be medical oncologists as well and then specialists in biostatistics. So probably a fairly typical and expected composition of the group, but certainly some neurologic oncologists who have familiarity with non-muscle invasive bladder cancer.

謝謝。因此，我認為簡短的回答是，嗯，我不知道其組成。我懷疑它會反映其他原子，特別是透過對太空中其他藥物的評估來反映。因此，我們希望一些泌尿科醫生，特別是神經腫瘤學家能夠期待我們在手術治療這種疾病方面有經驗。但我想也會有腫瘤醫學專家，以及生物統計學專家。因此，該小組的組成可能相當典型且在意料之中，但肯定有一些神經腫瘤學家熟悉非肌肉浸潤性膀胱癌。

Yeah, unfortunately, I don't have an answer to your question around the IP, but, well, I'll, I'll find out from the GC and I'll let you know.

是的，不幸的是，我無法回答您有關 IP 的問題，但是，我會從 GC 中找到答案，然後告訴您。

Thank you very much and congrats on all the progress, particularly the NBA acceptance. Very important for the company.

非常感謝，並祝賀你取得的所有進展，特別是獲得 NBA 的認可。對公司來說非常重要。

Thank you. Appreciate it.

謝謝。非常感謝。

Thank you one moment for our next question.

謝謝您，請回答我們的下一個問題。

Our next question comes from the line of Leland Gershen with Oppenheimer. Your line is now open.

我們的下一個問題來自奧本海默的 Leland Gershen。您的線路現已開通。

Yeah, thanks for the commentary and taking my questions. So, so just wanted to go in further on the on the it with respect to the type of litigation wondering if you can give us any timelines with respect to. Next steps is a Markman hearing being scheduled or hasn't been scheduled. Do you have any visibility on when that may occur?

是的，感謝您的評論和回答我的問題。所以，我只是想進一步探討有關訴訟的類型，想知道您是否可以給我們相關的時間表。下一步是安排或尚未安排馬克曼聽證會。您是否知道這種情況何時會發生？

Yeah, Leland, we, we don't have any additional updates at this point. We're obviously waiting to get our trial date. But typically, what happens is you see that closer to the 30-month mark. So, we expect that probably likely to happen in 2026. But, you know, we, we don't have that information yet. So, you know, to be H1st with you, we're sort of just moving forward with all of the, you know, typical, you know, things that we have to do at this point in relation to that, we feel very strongly, feel very good about our, our position and where we are and nothing has changed around that. So, you know, again, we're just, we're just going forward and waiting, you know, waiting for the date, but you know, preparing and making sure that we're fully prepared for the, for that outcome.

是的，Leland，我們目前沒有任何其他更新。我們顯然正在等待審判日期。但通常情況下，你會看到這種情況接近 30 個月大關。因此，我們預計這很可能在 2026 年發生。但你知道，我們還沒有這些資訊。所以，你知道，作為 H1st，我們只是在推進所有與此相關的典型事情，我們對我們的地位和現狀感到非常滿意，並且沒有任何改變。所以，你知道，再說一次，我們只是，我們只是繼續前進，等待，你知道，等待日期，但你知道，準備並確保我們為那個結果做好了充分的準備。

Okay. And, and what would the implications be, you know, for whatever the outcome is with the JMI of litigation? You know, would those carry over to presumably UGN 102 given overlapping IP. In other words, if you were to prevail, then presumably that would endure the ability for generic to 102. Is that a fair condition?

好的。而且，您知道，無論 JMI 訴訟的結果如何，這會有什麼影響？您知道，考慮到重疊 IP，這些是否會延續到大概的 UGN 102。換句話說，如果你要獲勝，那麼大概這將使通用的能力達到 102。這是一個公平的條件嗎？

Yes, that's a fair conclusion on that. And, you know, reality of it is, is that until we get an approval, they can't do anything. But yes, we, we fully expect that to happen. So in, in addition, a little difference with 102, we do have some other pending patents for UGN 102 that we think will even make that stronger than where, where, where we are to, you know, just put other things around it and just keep in mind and remember that for both of them, the next generation formulation for EGN 102, which is usually 103, we'll actually expect approve only 27. So, we that would actually be on the market before you ever even got regulatory exclusivity was up for you know, for UDM 102. So, we feel really good about kind of where we are with our patents, feel very strongly about them, but also feel good around the strategy that we built around it.

是的，這是一個合理的結論。你知道，事實是，在我們獲得批准之前，他們什麼都做不了。但是的，我們完全期待這樣的事情會發生。因此，此外，與 102 略有不同，我們確實有一些其他正在申請的 UGN 102 專利，我們認為這些專利將使其比我們要在它周圍添加其他東西時更強大，請記住，對於它們兩者，EGN 102 的下一代配方，通常是 103，我們實際上只希望批准 27 個。所以，在獲得 UDM 102 的監管獨佔權之前，我們實際上已經將其推向了市場。所以，我們對我們的專利現狀感到非常滿意，對它們有非常強烈的信心，而且對我們圍繞它制定的策略也感到滿意。

Okay. Thanks for taking the.

好的。感謝您的參與。

Preference.

偏愛。

Yeah, thanks Leland.

是的，謝謝 Leland。

Thank you.

謝謝。

Our next question comes from the line of Kelsey Goodwin with Guggenheim. Your line is now open.

我們的下一個問題來自古根漢的凱爾西古德溫。您的線路現已開通。

Oh, hey, everyone. Thanks for taking our questions and congrats on all the progress the last few months. I guess first from us, when would you expect to hear from the FDA around an ODAC timing or, or scheduling? Is there a time after which it could be ruled out? And then second, to what extent do you expect impact to the UN 102 uptake in the initial quarters with the miscellaneous J code versus the permanent J code likely in 2026. Thank you.

哦，嘿，大家好。感謝您回答我們的問題，並祝賀過去幾個月取得的所有進展。我想先請問您何時能從 FDA 獲得有關 ODAC 時間表或日程安排的資訊？過了某個時間之後，這種可能性就會被排除嗎？第二，您預計雜項 J 代碼與永久 J 代碼（可能在 2026 年）對最初幾季的 UN 102 採用率會產生多大影響。謝謝。

Yeah, great and nice to talk to you Chelsea. We you know, from, you know, from the standpoint of your last question on you know, on the miscellaneous code, I'll ask David to sort of comment, comment on that. But so David, you want to take that first? Yeah.

是的，很高興與您交談，切爾西。你知道，從你最後一個問題的角度來看，關於雜項代碼，我會請大衛對此進行評論。但大衛，你想先拿那個嗎？是的。

Hi Kelsey. Our expectation in terms of that initial period is not unlike a lot of the other drugs that are launched that have that same billing phenomenon. So, we expect that some customers may have a little bit more reservation around adopting, but we fully intend to be promoting to be educating and showing them with our reassurance in terms of training and operations of how to manage the billing during that cycle. And there's plenty of examples that we can draw on from not only Gilma but also other products that have launched in the space.

你好，Kelsey。我們對初始階段的預期與許多其他上市的具有相同計費現象的藥物並無不同。因此，我們預計一些客戶在採用方面可能會有更多的保留，但我們完全打算透過培訓和營運方面向他們推廣教育並向他們保證如何在該週期內管理帳單。我們不僅可以從 Gilma 中藉用許多例子，還可以從該領域推出的其他產品中藉鏡許多例子。

Yeah. And I think you know, in a in addition to that you, I think what you would expect is in the beginning, the sites of care very much like Mido as well. We're more in the hospital than they were in the community setting for that exact reason. To the question around the timing around ODAC. Look, I think we've been very clear, we expect a ODAC, we are in full preparation for an ODAC. We expect an ODAC, the agency has been very clear on that from, from the beginning, I, you know, really driven by the fact that this is a completely new way of treating these patients and they want to hear from key stakeholders. So we, we expect that to happen the timing on it. Usually you see the ODAC 2 to 3 months prior to the PDUFA. So we would expect the ODAC, you know, in the April time frame, it could go as late as May. And we expect the 2 to 3 months' notice. So, if it's May, then we expect to find out by the beginning of March, if it's April, you know, maybe the February, you know, beginning of again, beginning of March depending on when, when in April. So, April may timing for the actual ODAC. We there is the other sort of the next step is our mid cycle review meeting. We actually do have a meeting with them and, and that would be in kind of January February time frame. And we will ask at that meeting for an update on the ODAC and expect that we are aeast we'll get some acknowledgment and you know, idea of timing. But, you know, just to know we're in full ODAC preparation, we've actually always been welcomed in ode I know that, that sounds, you know, odd. But given what we know about users and physicians and, you know, practitioners and the way that they think about this, you know, we believe that that that would actually be helpful for us. And so, you know, we're, you know, we're very much like I said, in, in, in planning mode and excited about the team that we have around us and including the external experts that will be talking at the ODAC on our behalf. The patients that will be talking to ODAC on our behalf and believe that physicians and clinicians will actually welcome the opportunity to have a medicine like U GM 102.

是的。而且我想您知道，除此之外，我想您所期望的是，一開始，護理站點也非常像 Mido。正是因為這個原因，我們去醫院的時間比他們去社區的時間還要多。關於 ODAC 時間安排的問題。看，我認為我們已經非常清楚了，我們期待 ODAC，我們正在為 ODAC 做好充分準備。我們期待一個 ODAC，該機構從一開始就非常清楚這一點，你知道，這確實是因為這是一種治療這些患者的全新方式，他們希望聽取主要利益相關者的意見。因此，我們預計這將按時發生。通常您會在 PDUFA 之前 2 到 3 個月看到 ODAC。因此，我們預計 ODAC 將在 4 月進行，最晚可能會在 5 月進行。我們預計提前 2 至 3 個月收到通知。因此，如果是五月，那麼我們預計會在三月初得到結果，如果是四月，那或許是二月初，或者三月初，這取決於四月的具體時間。因此，四月可能是實際 ODAC 的時間。我們的下一步是舉行中期審查會議。我們確實與他們舉行了會議，時間大概是在一月或二月。我們將在該會議上詢問有關 ODAC 的最新消息，並期望我們能盡快得到一些確認，以及時間方面的資訊。但是，你知道，只是要知道我們已經為 ODAC 做好了充分的準備，我們實際上一直受到頌歌的歡迎，我知道，這聽起來很奇怪。但考慮到我們對使用者、醫生和從業者的了解以及他們對此的看法，我們相信這實際上對我們是有幫助的。所以，你知道，就像我說的，我們處於規劃模式，並且對我們周圍的團隊以及將代表我們在 ODAC 發言的外部專家感到興奮。患者將代表我們與 ODAC 進行交談，並相信醫生和臨床醫生實際上會歡迎獲得像 U GM 102 這樣的藥物的機會。

Great. Thank you so.

偉大的。非常感謝。

Much.

很多。

Thanks.

謝謝。

Thank you.

謝謝。

Our next question comes from the line of Matt Kaplan with Ladenburg Thalman. Your line is now open.

我們的下一個問題來自拉登堡·塔爾曼 (Ladenburg Thalman) 的馬特·卡普蘭 (Matt Kaplan)。您的線路現已開通。

Hey guys, thanks for taking the question and just wanted to follow up on, on the ODAC. I guess, you know, frequently ODAC's are called if there's some controversy. Can you talk a little bit about the buy in that you have from the FDA? On the, the Envision trial design is a single arm study and how it could suffice for the, the, the, the approval of 102? And does that is that also, is there any controversy there with respect to also, I guess Utopia's phase three design as, as very similar design to the envision study as well.

嘿夥計們，感謝你們回答這個問題，我只是想跟進一下 ODAC 的情況。我想，您知道，如果有爭議的話，經常會召開 ODAC 會議。您能否談談您從 FDA 獲得的支持？一方面，Envision 試驗設計是一項單臂研究，它如何能夠獲得 102 的批准？那麼，這是否也存在爭議呢？

Hey, Matt, it's Mark. Thanks for the question. So, I'm going to try to compress a long story into a short answer. But the answer is we had a meeting with the FDA during which they agreed in writing that envision could potentially support approval of EGN 102, which was in fact the gating conversation to the transition from the Atlas randomized trial to the envision single arm trial. So, we feel quite comfortable that there was a meeting of the minds on that question with respect to your sort of larger question about what are the controversies or what might be underlying the need for an OAC? I think we've also been briefed the idea that Eng wanted to present urologists and patients with a potentially paradigm changing approach to non-muscle las bladder cancer. So, we believe, and I think with good reason that the FDA would like to hold a public vetting with experts in the room to talk about what that would mean in terms of the practical application of the M 102 and its inclusion in the Armamentarium currently available to urologists for the treatment of this population of patients.

嘿，馬特，我是馬克。謝謝你的提問。因此，我將嘗試將長篇故事壓縮成一個簡短的答案。但答案是，我們與 FDA 舉行了一次會議，他們書面同意 Envision 可能支持批准 EGN 102，這實際上是從 Atlas 隨機試驗過渡到 Envision 單臂試驗的門控談話。因此，我們感到非常高興，對於您提出的更大問題，即存在哪些爭議或需要 OAC 的根本原因是什麼，大家在這個問題上達成了共識。我想我們也已經了解了這樣的想法，即 Eng 希望向泌尿科醫生和患者提供一種可能改變範式的非肌肉型膀胱癌治療方法。因此，我們相信，並且我認為有充分的理由表明， FDA 希望與專家進行一次公開審查，討論這對 M 102 的實際應用以及將其納入目前可供泌尿科醫生用於治療這類患者的醫療設備意味著什麼。

Okay, thank thanks, Mark. That's very helpful. And then just a question for Chris with respect to your cash runway. How should we think about that? You finished the quarter in a strong cash position. But I guess with the pending launch coming up second half of next year for 102.

好的，謝謝你，馬克。這非常有幫助。然後我只想問克里斯一個關於你的現金流的問題。我們該如何思考這個問題？本季結束時，您的現金狀況強勁。但我想 102 將於明年下半年上市。

Yeah, Matt, thanks for the question. So, you know, we, we exited with a fortified balance sheet, you know, $254 million in cash and we believe that we have the requisite cash to get the business, you know, to profitability based off of our current business objectives based off of the, the June PDUFA date.

是的，馬特，謝謝你的提問。因此，您知道，我們退出時擁有穩健的資產負債表，即 2.54 億美元現金，並且我們相信，我們擁有必要的現金，可以根據我們目前的業務目標（基於 6 月份的 PDUFA 日期）使業務盈利。

Great. Thanks for, thanks for taking the question guys.

偉大的。謝謝大家回答這個問題。

Thanks, Matt.

謝謝，馬特。

Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.

謝謝。為了提醒您提問，請在電話上按星號 11 並等待播報您的名字。我們的下一個問題來自高盛的 Paul Choi。您的線路現已開通。

Hi, everyone. This is Kle calling in for Paul. Thank you so much for taking our questions and congratulations on the ND A acceptance, I guess with regard to the updated commercial plan for Eugen 102. Could you perhaps provide an overview of how like the whole process could be improved and increment perhaps just in the context and the challenges some of the urologist's face with Joe Mido, whether that's access reimbursement, the process of actually administering the drug itself, etcetera. That'd be really helpful to get like a 30,000 ft view. Thank you so much.

大家好。這是克萊 (Kle) 代替保羅 (Paul) 打來的。非常感謝您回答我們的問題，我也祝賀 ND A 獲得批准，我想這與 Eugen 102 更新的商業計劃有關。您能否概述如何改善和增加整個過程，也許只是在背景和一些泌尿科醫生在使用 Joe Mido 時面臨的挑戰方面，無論是獲得報銷，還是實際管理藥物的過程本身，等等。這對於獲得 30,000 英尺的視野非常有幫助。太感謝了。

David. Yeah. Thanks for the question. So I think a couple of things when we draw on, we, we take what we've learned from gel Mido. And we also think about the unique nature of treating patients with low grade intermediate risk, non muscle invasive bladder cancer. So a couple of things, what we learned about Joe Mido is that the operational financial support has to immediately follow the clinical discussion. So once we've identified that there's clinical conviction around identifying patients and treating with gel mido, we immediately follow up with helping them to operationalize the actual six doses and then make sure that they have the education and support from a reimbursement perspective. All of that will still hold true with a potential UGN 102 approval. What's important also is what's different with GM 102 I'll say is that because it is a process that is much more familiar to the physician offices, we will still do the requisite training from a clinical perspective. But one of the things we will also do is right up front, help them understand how this fits into their workflow and how they identify the low grade intermediate risk, non muscle invasive bladder cancer patients. So all of that together is we will leverage everything we learned about mito we'll pivot accordingly to the new patient population. But all of that just means that we will continue to drive clinical conviction upon approval and also support them operationally and financially. And it is worth reminding that ahead of PDUFA, our medical affairs team continues to educate the urology community on the envision data and the unmet need in low grade intermediate risk, non muscle invasive bladder cancer.

大衛。是的。謝謝你的提問。因此，我認為，當我們借鑒時，我們會從 Gel Mido 學到的東西中學習。我們也考慮了治療低度中度風險、非肌肉層浸潤性膀胱癌患者的獨特性。因此，我們從 Joe Mido 了解到的一些情況是，營運財務支援必須立即跟進臨床討論。因此，一旦我們確定臨床上確信可以識別患者並使用 gel mido 進行治療，我們會立即跟進，幫助他們實施實際的六劑治療，然後確保他們從報銷的角度接受教育和支持。如果 UGN 102 獲得批准，那麼所有這些仍然適用。同樣重要的是，我要說的是，GM 102 的不同之處在於，由於該過程對於醫生辦公室來說更為熟悉，因此我們仍將從臨床角度進行必要的培訓。但我們首先要做的事情之一就是幫助他們了解這如何適應他們的工作流程以及如何識別低度中度風險、非肌肉層浸潤性膀胱癌患者。所以，我們將綜合利用所有這些知識，以適應新的患者群體。但所有這些僅意味著我們將在批准後繼續推動臨床信念，並在營運和財務上為他們提供支援。值得提醒的是，在 PDUFA 之前，我們的醫療事務團隊將繼續向泌尿科界宣傳有關低度中度風險、非肌肉浸潤性膀胱癌的預期數據和未滿足的需求。

And just to add a couple of things to that one, remember the rare disease nature of John Mido firsts, the not so rare disease nature versus of Eugene 102. So, all physicians I mentioned earlier, I see these patients and you don't need special equipment. It's done by a nurse in the office. To your point about the ease of use. And we have learned that, you know, g mido is hard, you know, the, the physicians will say it's a, it's a heavy lift for the practice and a heavy lift.

再補充幾點，請記住，John Mido 首例病例屬於罕見疾病，而 Eugene 102 病例則屬於較不罕見的疾病。所以，我之前提到的所有醫生，我看這些病人，不需要特殊的設備。這是由辦公室裡的一名護士完成的。關於您提到的易用性。我們已經知道，g mido 很難，醫生會說，對於實踐來說，這是一個沉重的負擔。

And so, the bar was definitely very different. And even though we've done, I think a really good job of supporting as best we can and at the end of the day, it is what it is, right? You either have to have a fluoroscopy, you know, manipulate the upper track or you've got to have a nephrostomy tube. And so, I think when you look at U GM 102 and the ease of use around that, and we've heard that from, you got the feedback from all the physicians we've spoken to and the practices that we've spoken to is going to be a very, very different situation.

所以，酒吧肯定是非常不同的。儘管我們已經盡力了，但我認為我們已經盡力提供了很好的支持，最終，事情就是這樣，對吧？您必須進行螢光透視檢查，或操作上通道，或必須使用腎造口管。因此，我認為當您查看 U GM 102 及其易用性時，我們已經聽說了這一點，您從我們交談過的所有醫生那裡得到了反饋，並且我們交談過的實踐將是一個非常非常不同的情況。

But thanks for the question.

但感謝您的提問。

Thank you.

謝謝。

Thank you.

謝謝。

I am showing no further questions at this. Time I would now like to turn it back to Liz Barrett for closing remarks.

對此我沒有其他疑問。現在我想請莉茲·巴雷特作最後發言。

Okay. Thank you. You know, we continue to make progress across the company with our priorities and you know, really do believe that we're uniquely positioned company to change the practice for bladder cancer in these patients and also to bring significant value to our shareholders. So as always, we appreciate your support, and we'll keep you posted on things as they arise. So, appreciate it. Thank you.

好的。謝謝。您知道，我們在整個公司範圍內繼續按照我們的優先事項取得進展，您知道，我們確實相信，我們是一家具有獨特優勢的公司，能夠改變這些患者治療膀胱癌的治療方法，同時也為我們的股東帶來重大價值。因此，與往常一樣，我們感謝您的支持，並將隨時向您通報最新情況。所以，請珍惜吧。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。這確實完成了該程序，您現在可以斷開連接。