Urogen Pharma Ltd (URGN) 2024 Q4 法說會逐字稿

Good morning, ladies and gentlemen and thank you for standing by. Welcome to the UroGen Pharma of fourth quarter and full year 2024 earnings call. Please be advised that today's conference is being recorded.

女士們、先生們，早安，謝謝你們的支持。歡迎參加 UroGen Pharma 2024 年第四季和全年財報電話會議。請注意，今天的會議正在錄音。

I would now like to hand the conference over to your speaker today, Vincent Perrone, Head of Investor Relations. Please go ahead.

現在，我想將會議交給今天的發言人、投資者關係主管 Vincent Perrone。請繼續。

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's fourth quarter and full year 2024 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 fourth quarter and year ended December 31, 2024.

謝謝您，接線生。大家早安，歡迎參加 UroGen Pharma 2024 年第四季和全年財務業績及業務更新電話會議。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以及截至 2024 年 12 月 31 日的第四季度和年度的財務業績。

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

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。今天與我一起參加電話會議的還有總裁兼首席執行官 Liz Barrett；首席醫療官 Mark Schoenberg 博士； David Lin，首席商務官；以及首席財務官 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, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as potential future commercialization activities for UGN-102, if approved.

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 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 UGN-102（如果獲得批准）未來的潛在商業化活動的聲明。

Anticipated data, regulatory filings, and decisions, UGN-102 being the primary growth driver for UroGen if approved, future R&D efforts, our corporate goals, and 2025 financial guidance, among other things.

預期數據、監管備案和決策、UGN-102（如果獲得批准）成為 UroGen 的主要成長動力、未來的研發工作、我們的企業目標以及 2025 年財務指導等。

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. We 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。我們被告誡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, and thank you for joining us this morning. 2024 was a year of progress for UroGen as we continue to advance our mission of pioneering new therapies that meet the unique needs of patients with urothelial and specialty cancers.

謝謝你，文森特，謝謝你今天早上加入我們。 2024 年是 UroGen 進步的一年，我們將繼續推進我們的使命，開拓新的療法，滿足尿路上皮癌症和特種癌症患者的獨特需求。

We achieved a major milestone by submitting a new drug application for UGN-102, our investigational product for intermediate risk, low grade non-muscle invasive bladder cancer, ahead of schedule. With FDA review underway in a PDUFA target date of June 13, we are well positioned to bring this innovative therapy to patients.

我們提前提交了 UGN-102（我們針對中度風險、低度非肌肉層浸潤性膀胱癌的研究產品）的新藥申請，實現了一個重要的里程碑。隨著 FDA 按照 PDUFA 目標日期 6 月 13 日進行審查，我們已準備好為患者提供這種創新療法。

At the same time, we continue to generate compelling clinical data that reinforces UGN-102's safety, efficacy, and paradigm changing potential. Our commercial product JELMYTO continues to grow, and we have made meaningful progress advancing our early-stage pipeline. Additionally, we strengthened our leadership team, ensuring we have the expertise and vision to drive UroGen's next phase of success.

同時，我們繼續產生令人信服的臨床數據，以增強 UGN-102 的安全性、有效性和範式改變潛力。我們的商業產品 JELMYTO 持續成長，我們在推動早期產品線方面取得了有意義的進展。此外，我們加強了領導團隊，確保我們擁有推動 UroGen 下一階段成功的專業知識和遠見。

I will begin with an important clinical update on the pivotal vision Phase 3 trial that serves as a foundation for the UGN-102 NDA submission. ENVISION demonstrated a compelling complete response rate and unprecedented durability. As a reminder, the CR rate at 3 months stood as an impressive 79.6%, and the 12 month duration of response was an unprecedented 82.3% by Kaplan-Meier analysis.

我首先會介紹關鍵視力第 3 階段試驗的重要臨床更新，該試驗是 UGN-102 NDA 提交的基礎。ENVISION 展現出了令人信服的完全反應率和前所未有的耐用性。提醒一下，根據 Kaplan-Meier 分析，3 個月的 CR 率高達 79.6%，12 個月的反應持續時間達到了前所未有的 82.3%。

As the data continue to mature, we are highly encouraged by the disease-free status of many patients in follow-up. Today we are reporting updated 18 month duration of response data from ENVISION and note that these results remain consistent with our previous Kaplan-Meier estimates.

隨著數據不斷成熟，我們對後續許多患者的無病狀態感到非常鼓舞。今天，我們報告了 ENVISION 更新的 18 個月回應持續時間數據，並注意到這些結果與我們先前的 Kaplan-Meier 估計值保持一致。

With 101 patients now followed for at least 18 months following CR, or 21 months post-therapy start. The updated duration of response is 80.6%. By Kaplan-Meier analysis, the median follow up time for these patients has now extended to 18.7 months after 3 months CR, up from 13.8 months at the previous data cut, and the median duration of response is still not reached.

目前，已有 101 名患者在完全緩解後接受至少 18 個月的隨訪，或在治療開始後接受至少 21 個月的隨訪。更新後的緩解持續時間為80.6%。根據 Kaplan-Meier 分析，這些患者的中位追蹤時間現已延長至 3 個月 CR 後的 18.7 個月，高於上次數據截斷時的 13.8 個月，且仍未達到中位反應持續時間。

We have provided these data to the FDA in our 120 day update, and they will be part of the submission. The durability of response is critical for a disease with historically high recurrence rate. By extending disease-free periods, UGN-102 has the potential to increase disease and treatment-free intervals, which are associated with morbidity and quality of life challenges in this population.

我們在 120 天更新中向 FDA 提供了這些數據，它們將成為提交文件的一部分。對於歷史上復發率較高的疾病來說，治療反應的持久性至關重要。透過延長無病期，UGN-102 有可能增加疾病和無治療間隔，這與該族群的發病率和生活品質挑戰有關。

We engaged with the FDA in a productive mid-cycle review meeting this past week. The agency confirmed they will be referring the NDA to ODAC. They previously indicated the meeting will take place in May, and we are awaiting official publication of the meeting date in the federal registry.

上週我們與 FDA 進行了一次富有成效的中期審查會議。該機構確認他們將把保密協議提交給 ODAC。他們之前表示會議將於 5 月舉行，我們正在等待聯邦登記處正式公佈會議日期。

We aligned with the agency that the advisory committee presentation and materials were focused on the recurrent patient population studied in the ENVISION trial.

我們與該機構保持一致，諮詢委員會的報告和材料重點關注 ENVISION 試驗中研究的複發患者群體。

Therefore, we believe that UGN-102, if approved, will be indicated in the recurrent patient population. It's important to highlight that our data in this population is highly supportive, and this group represents the vast majority of the overall revenue opportunity.

因此，我們相信，UGN-102 如果獲得批准，將適用於復發患者群體。值得強調的是，我們對這群人的數據具有很強的支持性，而這群人代表了整體收入機會的絕大部分。

While these meetings are confidential and there's a limit to what we can share today, I want to take this opportunity to reaffirm our confidence in the strength of the data package we have submitted and in the potential of UGN-102 to address the significant unmet need for patients.

雖然這些會議是保密的，而且我們今天可以分享的內容有限，但我想藉此機會重申我們對所提交資料包的強度以及 UGN-102 解決患者未滿足的重大需求的潛力的信心。

We remain fully focused on preparing for our ODAC and look forward to the opportunity to present our compelling data to the advisory committee and engage with the broader medical community. If approved, UGN-102 will become the first medicine for this patient population, introducing a potentially paradigm shifting solution for this disease.

我們將繼續全力準備 ODAC，並期待有機會向諮詢委員會展示我們令人信服的數據並與更廣泛的醫學界進行交流。如果獲得批准，UGN-102 將成為針對該患者群體的首個藥物，為該疾病帶來潛在的範式轉移解決方案。

An approval of UGN-102 will be transformative for UroGen as it represents a significant market opportunity, a population nearly 10 times larger than the market for JELMYTO. This translates to a total addressable market of more than $5 billion. Importantly, our ability to identify and target physicians and their patients for UGN-102 will be easier.

UGN-102 的批准將對 UroGen 產生變革性的影響，因為它代表著一個巨大的市場機遇，其市場規模幾乎是 JELMYTO 市場的 10 倍。這意味著總目標市場規模超過 50 億美元。重要的是，我們將更容易識別和定位使用 UGN-102 的醫生及其患者。

Unlike low-grade upper tract urothelial carcinoma, which is a dispersed rare disease, low-grade intermediate risk non-muscle invasive bladder cancer is widespread and managed by nearly all urologists. UGN-102 is designed for seamless integration into outpatient practice workflows. The ease of use creates the opportunity for physicians to expand their practices and enhance patient care.

與低度上尿路上皮癌（一種分散的罕見疾病）不同，低度中危非肌肉層浸潤性膀胱癌廣泛存在，幾乎所有泌尿科醫師都可以治療。UGN-102 旨在無縫整合到門診實踐工作流程中。易於使用為醫生創造了擴大實踐和加強患者護理的機會。

JELMYTO generated net product revenues of $90.4 million for the full year 2024, compared to $82.7 million for the prior year. The increase of $7.7 million year over year was primarily driven by increased underlying demand for JELMYTO, partially offset by a decrease and creates excels and an increase in 340B chargebacks. If we focus on actual underlying product demand.

JELMYTO 2024 年全年淨產品收入為 9,040 萬美元，而前一年為 8,270 萬美元。與去年同期相比，增加了 770 萬美元，主要是因為 JELMYTO 的潛在需求增加，但被銷售額的減少和 340B 退款的增加部分抵消。如果我們專注於實際的潛在產品需求。

Sales grew by approximately 12% year over year. Our commercial team recognizes this is a high touch product, so we have been focused on increasing our reach and frequency with key accounts. This has resulted in consistent improvement across several key metrics, including overall volume, patient enrolment forms, and new patient starts, new scriptwriters, and new sites of care.

銷售額較去年同期成長約12%。我們的商業團隊意識到這是一款高接觸產品，因此我們一直致力於增加對主要客戶的覆蓋率和頻率。這使得幾個關鍵指標得到了持續改善，包括總體數量、患者登記表、新患者開始數量、新編劇和新護理地點。

In Q4 2024, we saw our highest ever number of demand units. David Lin will provide more details in his update. We have also made great progress in advancing our long-term growth strategy with the recent acquisition of ICVB-1042 from IconOVir.

2024 年第四季度，我們的需求單位數量達到了歷史最高水準。David Lin 將在他的更新中提供更多詳細資訊。我們最近從 IconOVir 收購了 ICVB-1042，在推動長期成長策略方面也取得了巨大進展。

This next-generation investigational oncolytic virus represents an exciting opportunity in cancer care. With its unique mechanism, ICVB-1042 is designed to selectively target and destroy tumor cells without compromising its lytic activity. It's designed to enter a broad spectrum of tumor cells, allowing it to potentially treat a wide range of tumor types.

這種下一代研究溶瘤病毒代表著癌症治療的一個令人興奮的機會。ICVB-1042 憑藉其獨特的機制，旨在選擇性地靶向和破壞腫瘤細胞，而不會損害其溶解活性。它旨在進入廣泛的腫瘤細胞，從而有可能治療多種類型的腫瘤。

This acquisition aligns with our vision and strategic focus to develop innovative therapies to address critical gaps in cancer care. For those interested, a replay of our investor webinar announcing the acquisition is available on our website.

此次收購符合我們的願景和策略重點，即開發創新療法來解決癌症治療的關鍵差距。對於有興趣的人，可以在我們的網站上觀看宣布此次收購的投資者網路研討會的重播。

UroGen ended 2024 with a strong balance sheet holding $241.7 million in cash equivalents, and marketable securities. We remain well capitalized to execute our operating plan and advance the company to and through profitability with the anticipated launch of UGN-102 later this year.

截至 2024 年，UroGen 擁有強勁的資產負債表，持有 2.417 億美元的現金等價物和有價證券。我們仍然擁有充足的資金來執行我們的營運計劃，並隨著今年稍後預計推出的 UGN-102 推動公司實現盈利。

I will now turn the call over to Mark Schoenberg, our Chief Medical Officer for a clinical update. Mark.

現在我將把電話轉給我們的首席醫療官馬克‧勳伯格 (Mark Schoenberg)，以了解臨床最新情況。標記。

Thank you, Liz. Beginning with the NDA for UGN-102, our clinical and regulatory teams are fully engaged in preparing for the ODAC meeting, where UGN-102 will be reviewed as a potential paradigm shift in the treatment of low-grade intermediate risk non-muscle invasive bladder cancer.

謝謝你，莉茲。從 UGN-102 的 NDA 開始，我們的臨床和監管團隊就全力投入 ODAC 會議的準備工作中，在 ODAC 會議上，UGN-102 將作為治療低度中度風險非肌肉層浸潤性膀胱癌的潛在範式轉變進行審查。

We believe a key consideration for the FDA is that UGN-102 represents a fundamental change in how we approach this disease, moving away from repetitive surgical procedures that have been the standard for decades. We feel confident heading into this discussion.

我們認為，FDA 的一個關鍵考慮因素是，UGN-102 代表了我們治療這種疾病方式的根本性改變，擺脫了幾十年來一直是標準的重複手術程序。我們對這次討論充滿信心。

Neurologists appreciate the need for alternative treatment options that could potentially provide a longer treatment and recurrence-free survival and UGN-102 has the potential to fill this gap, offering office-based administration that aligns with the way urologists practice.

神經科醫生認識到需要替代治療方案，以便能夠提供更長的治療時間和無復發生存期，而 UGN-102 有可能填補這一空白，提供與泌尿科醫生實踐方式一致的辦公室管理。

The body of clinical evidence supporting UGN-102 continues to grow. Liz highlighted the latest duration of response data from vision, showing an impressive 80.6% duration of response at 18 months for those patients who had achieved a complete response to 3 months.

支持 UGN-102 的臨床證據不斷增加。Liz 重點介紹了最新的視力反應持續時間數據，顯示對於那些在 3 個月內達到完全緩解的患者來說，18 個月的反應持續時間達到了令人印象深刻的 80.6%。

We will continue to follow these patients, but the current data represents a potentially significant advance for patients as we have not reached a median duration of response. We continue to appropriately engage with the broader medical community to share our clinical findings from ENVISION.

我們將繼續追蹤這些患者，但由於我們尚未達到平均反應持續時間，因此目前的數據對患者來說可能代表著重大進展。我們將繼續與更廣泛的醫學界進行適當的接觸，分享我們在 ENVISION 上的臨床發現。

The ENVSION trial results were recently published in the February print edition of the Journal of Urology and were also presented at the Society of Urologic Oncology, or SUO annual meeting, which took place in Dallas in December.

ENVSION 試驗結果最近發表在《泌尿外科雜誌》 2 月的印刷版上，並在 12 月於達拉斯舉行的泌尿腫瘤學會 (SUO) 年會上進行了公佈。

At SUO we also had the opportunity to present long term follow up data from the OLYMPUS trial, which demonstrated a median duration of response of approximately four years in patients who had achieved a complete response with JELMYTO. These data further reinforced JELMYTO'S role as a primary treatment for low grade upper tract urothelial cancer, providing patients with a meaningful alternative to surgery.

在 SUO，我們還有機會展示 OLYMPUS 試驗的長期追蹤數據，該數據表明，使用 JELMYTO 獲得完全緩解的患者的中位緩解持續時間約為四年。這些數據進一步強化了 JELMYTO 作為低度上泌尿道尿路上皮癌主要治療方法的作用，為患者提供了有意義的手術替代方案。

In January, previously announced results from the real-world post-commercialization study of JELMYTO were published in neurologic oncology. This long-term study evaluated 56 patients from 15 high volume centres which achieved complete responses with JELMYTO, demonstrating a recurrence-free survival rate of 68% at three years.

今年 1 月，JELMYTO 真實世界商業化後研究的先前發表的結果在《神經腫瘤學》上發表。這項長期研究評估了來自 15 個高容量中心的 56 名患者，這些患者使用 JELMYTO 獲得了完全緩解，三年無復發生存率為 68%。

Notably, recurrence for survival was consistent irrespective of tumor size, location, number of tumors, and route of administration, with no difference between primary chemo ablation and as adjuvant therapy post-endoscopic ablation. These findings further support the use of JELMYTO in a broad patient population.

值得注意的是，無論腫瘤大小、位置、腫瘤數量和給藥途徑如何，生存復發率都是一致的，初次化學消融和內視鏡消融後輔助治療之間沒有差異。這些發現進一步支持在廣大患者群體中使用 JELMYTO。

Turning now to the pipeline, we have a comprehensive life cycle management plan for JELMYTO and UGN-102. Enrolment continues in the Phase 3 UTOPIA trial, which is evaluating UGN-103, our next generation product for low-grade intermediate risk NMIBC. UTOPIA is a single-arm multi-centre study with a protocol similar to the ENVISION trial.

現在談到管道，我們對 JELMYTO 和 UGN-102 有一個全面的生命週期管理計劃。第三階段 UTOPIA 試驗的招募工作仍在繼續，該試驗正在評估 UGN-103，這是我們針對低中度風險 NMIBC 的下一代產品。UTOPIA 是一項單組多中心研究，其方案與 ENVISION 試驗類似。

Low-grade intermediate risk disease patients with recurrent disease are 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, and patients will be followed to evaluate durability of response.

患有復發性疾病的低度中度風險疾病患者每週透過膀胱內植入接受一次 UGN-103，持續六週。將根據三個月時的完全緩解率來評估療效，並將對患者進行追蹤以評估緩解的持久性。

We expect a complete enrolment this year and anticipate reporting top line data in 2026. We have a similar development plan for UGN-104, our next generation formulation of JELMYTO, and expect to commence a single arm Phase 3 study in the first half of 2025.

我們預計今年將完成全部招生，並預計在 2026 年報告頂線數據。我們對 JELMYTO 的下一代製劑 UGN-104 也有類似的開發計劃，預計將於 2025 年上半年開始單臂 3 期研究。

In February, we were pleased to announce the acquisition of ICVB-1042, next-generation investigational oncolytic virus developed by IconOVir. This edition meaningfully enhances UroGen's pipeline by introducing a highly innovative approach to selectively targeting and destroying cancer cells while simultaneously activating a robust anti-tumor immune response.

二月份，我們很高興地宣布收購了由 IconOVir 開發的下一代研究性溶瘤病毒 ICVB-1042。此版本透過引入一種高度創新的方法來選擇性地瞄準和摧毀癌細胞，同時激活強大的抗腫瘤免疫反應，從而顯著增強了 UroGen 的產品線。

1042 was thoughtfully engineered to achieve efficient cell entry, strong selectivity for malignant cells, and rapid replication within the tumor microenvironment, features that drive both direct tumor cell lysis and the induction of a durable tumor specific immune response. Our development plan for 1042 is advancing. With IND enabling studies expected to begin this year. We intend to evaluate several modes of administration, including delivery using our proprietary RTGel technology.

1042 經過精心設計，可實現高效的細胞進入、對惡性細胞的強選擇性以及在腫瘤微環境中的快速複製，這些特性可直接驅動腫瘤細胞裂解並誘導持久的腫瘤特異性免疫反應。我們的1042開發計畫正在進行中。IND 支持研究預計今年開始。我們打算評估幾種管理模式，包括使用我們專有的 RTGel 技術進行交付。

While our initial focus will be on bladder cancer, we anticipate exploring 1042's potential to address a broader range of malignancies beyond the genitourinary space. Finally, UroGen will have a significant presence at this year's American Urology Association meeting to take place April 26 to 29. In Las Vegas, Nevada.

雖然我們最初的重點是膀胱癌，但我們期待探索 1042 治療泌尿生殖系統以外更廣泛的惡性腫瘤的潛力。最後，UroGen 將在今年 4 月 26 日至 29 日舉行的美國泌尿外科協會會議上發揮重要作用。在內華達州拉斯維加斯。

This is an important conference for us, and I'm pleased to say that we have six abstracts accepted this year. These include a podium presentation of the ENVISION trial results by Dr. Sandip Prasad, the principal investigator of the UGN-102 trial.

這對我們來說是一次重要的會議，我很高興地說，今年我們有六篇摘要被接受。其中包括 UGN-102 試驗首席研究員 Sandip Prasad 博士在講台上展示 ENVISION 試驗結果。

Now over to David Lin for a commercial update.

現在請 David Lin 介紹商業更新情況。

Thank you, Mark. Good morning, everyone. I'm pleased to provide an update on our commercial initiatives as we move closer to the PDUFA target action date for UGN-102. The upcoming launch would mark a pivotal moment in UroGen's evolution from a rare disease-focused company to a multi-product specialty driven team.

謝謝你，馬克。大家早安。隨著我們越來越接近 UGN-102 的 PDUFA 目標行動日期，我很高興提供有關我們商業計劃的最新消息。即將推出的產品將標誌著 UroGen 從專注於罕見疾病的公司轉變為多產品專業驅動團隊的關鍵時刻。

Our goal is to deliver a seamless and successful launch, ensuring that our efforts translate into patient access to this potentially groundbreaking therapeutic option. Our immediate priority is continuing to execute our comprehensive pre-commercial strategy that we believe will lay a strong foundation for widespread access and adoption of UGN-102.

我們的目標是實現無縫且成功的發布，確保我們的努力轉化為患者能夠獲得這種具有突破性的治療選擇。我們的當務之急是繼續執行全面的商業化前策略，我們相信這將為 UGN-102 的廣泛使用和採用奠定堅實的基礎。

We are confident in the strength of our clinical data and the potential it holds for patients with low grade intermediate risk non-muscle invasive bladder cancer. We're focused on three key priorities in our pre-approval preparation.

我們對我們的臨床數據的強度及其對低度中度風險非肌肉層浸潤性膀胱癌患者的潛力充滿信心。我們在審批前的準備中重點放在三個關鍵優先事項。

First, we're actively working to raise awareness about the unmet needs in low-grade intermediate risk, non-muscle invasive bladder cancer through a variety of educational programs. Our medical affairs team is engaging in scientific exchange activities involving the clinical data supporting UGN-102.

首先，我們正在積極努力透過各種教育計畫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。我們的醫學事務團隊正在從事涉及支持 UGN-102 的臨床數據的科學交流活動。

Next, we continue to gather insights across key stakeholders such as prescribers, payers, and patients in order to refine our launch plans. Of course, we'll leverage learnings we have gained through our experience with JELMYTO.

接下來，我們將繼續收集處方者、付款人和患者等主要利害關係人的見解，以完善我們的發布計劃。當然，我們會利用透過 JELMYTO 獲得的經驗教訓。

And finally, we are scaling our commercial infrastructure and capabilities to ensure we're appropriately sized to fully address the opportunity for UGN-102, if approved. We are significantly expanding our sales force from 52 reps today to approximately 83 at our anticipated launch.

最後，我們正在擴大我們的商業基礎設施和能力，以確保我們擁有適當的規模，並在獲得批准後充分抓住 UGN-102 的機會。我們將大幅擴大銷售隊伍，從目前的 52 名銷售代表增加到預計推出時的約 83 名。

We are also building out our customer support capabilities to support a broader portfolio, particularly in our ability to provide comprehensive training and support for healthcare professionals and their staff to ensure seamless integration of UGN-102 into treatment protocols.

我們也正在建立我們的客戶支援能力，以支援更廣泛的產品組合，特別是為醫療保健專業人員及其員工提供全面的培訓和支持，以確保 UGN-102 與治療方案無縫整合。

Additionally, we are preparing our engagement initiatives to inform both clinical practices and patients about UGN-102's coverage options and reimbursement. While UGN-102 will initially be assigned a miscellaneous J-code for billing, we expect to secure a permanent J-code by January 2026, which will be particularly important in the community setting.

此外，我們正在準備參與計劃，以告知臨床實踐和患者有關 UGN-102 的承保選項和報銷情況。雖然 UGN-102 最初將被分配一個雜項 J 代碼用於計費，但我們預計到 2026 年 1 月將獲得永久的 J 代碼，這在社區環境中尤其重要。

In the interim, we are fully committed to offering strong reimbursement support to help providers navigate the coding process, helping to ensure the integration of UGN-102 is as smooth as possible. We are on the cusp of a truly exciting launch, and we are energized by the opportunity to bring this investigational treatment to patients and continue making strides in the fight against bladder cancer.

在此期間，我們全力致力於提供強有力的報銷支持，幫助提供者完成編碼過程，幫助確保 UGN-102 的整合盡可能順利。我們正處於一個真正令人興奮的發布之初，我們為有機會將這種研究性治療方法帶給患者並繼續在對抗膀胱癌的鬥爭中取得進展而感到振奮。

Turning to JELMYTO, as Liz mentioned, the product delivered $87.4 million in underlying demand revenue in 2024, an increase of 12% versus the prior year. Fourth quarter underlying demand revenues increased 15% year over year, and we saw consistent improvement across multiple key metrics.

談到 JELMYTO，正如 Liz 所提到的，該產品在 2024 年實現了 8,740 萬美元的潛在需求收入，比前一年增長 12%。第四季基礎需求收入年增 15%，我們看到多個關鍵指標持續改善。

Demand units in Q4 were our highest ever, up 15% compared to Q4 of last year. New prescribers and new patient start increased 33% and 13% respectively in 2024 compared to 2023. The recent clinical data and publications that Mark referenced, including the long-term follow-up from OLYMPUS and positive results from the real-world study, further underscore the impressive durability of JELMYTO.

第四季的需求單位數量是我們有史以來最高的，與去年第四季相比成長了 15%。與 2023 年相比，2024 年新開處方者和新患者數量分別增加了 33% 和 13%。Mark 引用的最新臨床數據和出版物，包括 OLYMPUS 的長期追蹤和真實世界研究的積極結果，進一步強調了 JELMYTO 令人印象深刻的耐用性。

These results continue to reinforce its important role in treating low grade upper tract urothelial cancer. We are continuing our high-tech strategy with a focused effort on key accounts, ensuring JELMYTO remains a key part of our commercial portfolio. As we expand our sales force in preparation for the UGN-102 launch, the new representatives will also be promoting JELMYTO.

這些結果繼續強化了其在治療低度上尿路上皮癌的重要作用。我們將繼續實施高科技策略，重點關注重點客戶，確保 JELMYTO 仍然是我們商業組合的重要組成部分。隨著我們擴大銷售隊伍以準備推出 UGN-102，新代表也將推廣 JELMYTO。

This strategic increase in our sales team is designed to drive growth for both products, enhancing our ability to support key accounts and maximize market impact.

我們銷售團隊的這項策略性擴張旨在推動這兩種產品的成長，增強我們支持關鍵客戶和最大化市場影響力的能力。

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. Before I turn to our financial results, I'm pleased to report UroGen and 2025 from a position of financial strength. At the close of 2024, cash equivalents, and marketable securities totaled $241.7 million providing a solid foundation to continue executing on our strategic initiatives.

謝謝你，大衛。在介紹我們的財務表現之前，我很高興地報告 UroGen 和 2025 的財務實力。截至 2024 年底，現金等價物和有價證券總額為 2.417 億美元，為繼續執行我們的策略計畫奠定了堅實的基礎。

With the anticipated launch of UGN-102 later this year, we are well equipped to drive our company towards profitability and create long-term value for our shareholders.

隨著 UGN-102 預計今年稍後推出，我們有能力推動公司獲利並為股東創造長期價值。

Turning now to our financial results, JELMYTO net product revenues were $24.6 million in the fourth quarter of 2024 compared to $23.5 million for the same period in 2023. Underlying demand revenue increased by 15%, partially offset by decrease and creates a sales, which totaled $0.2 million in the fourth quarter of 2024, compared to $2.4 million for the same period in 2023.

現在來看看我們的財務業績，JELMYTO 2024 年第四季的淨產品收入為 2,460 萬美元，而 2023 年同期為 2,350 萬美元。基礎需求收入成長了 15%，但部分被下降所抵消，並創造了銷售額，2024 年第四季總計 20 萬美元，而 2023 年同期為 240 萬美元。

JELMYTO net product revenues for the full year ended December 31, 2024 were $90.4 million compared with $82.7 million of revenue in 2023. Research and development expenses for the fourth quarter of 2024 were $14.9 million as compared to $11.3 million for the same period in 2023.

截至 2024 年 12 月 31 日的全年 JELMYTO 淨產品收入為 9,040 萬美元，而 2023 年的收入為 8,270 萬美元。2024 年第四季研發費用為 1,490 萬美元，而 2023 年同期為 1,130 萬美元。

R&D expenses for the full year 2024 were $57.1 million compared with $45.6 million for 2023. The year over year increase was primarily driven by manufacturing expenses for our product candidates, regulatory expenses related to UGN-102, and costs associated with the UGN-103 UTOPIA trial.

2024 年全年研發費用為 5,710 萬美元，而 2023 年為 4,560 萬美元。同比增長主要由於我們候選產品的製造費用、與 UGN-102 相關的監管費用以及與 UGN-103 UTOPIA 試驗相關的成本。

SG&A expenses for the fourth quarter of 2024 were $34.9 million compared to $24.6 million in the same period in 2023. For the full year 2024, SG&A expenses were $121.2 million compared with $93.3 million in 2023.

2024 年第四季的銷售、一般及行政費用為 3,490 萬美元，而 2023 年同期為 2,460 萬美元。2024 年全年銷售、一般及行政費用為 1.212 億美元，而 2023 年為 9,330 萬美元。

The year over year increase was primarily driven by UGN-102 commercial preparation activities. We reported non-cash financing expense related to the pre-paid forward obligation to RTW investments of $6.1 million in the fourth quarter of 2024 compared to $5.5 million in the same period in 2023.

年比成長主要得益於 UGN-102 商業準備活動。我們報告稱，2024 年第四季與 RTW 投資預付遠期債務相關的非現金融資費用為 610 萬美元，而 2023 年同期為 550 萬美元。

non-cash financing expense related to RTW investments was $23.4 million in the full year 2024 compared with $21.6 million in 2023. Interest expense related to the outstanding $125 million term loan facility with Pharmakon Advisors was $3.9 million and $12.5 million respectively, for the fourth quarter and full year 2024 compared with $3.6 million and $14.7 million respectively for the fourth quarter and full year 2023.

2024 年全年與 RTW 投資相關的非現金融資費用為 2,340 萬美元，而 2023 年為 2,160 萬美元。2024 年第四季和全年與 Pharmakon Advisors 未償還 1.25 億美元定期貸款相關的利息支出分別為 390 萬美元和 1,250 萬美元，而 2023 年第四季和全年分別為 360 萬美元和 1,470 萬美元。

Net loss was $37.5 million or $0.80 per basic and diluted share in the fourth quarter of 2024 compared with a net loss of $26 million or $0.72 per basic and diluted share in the same period in 2023. For the full year 2024, net loss was $126.9 million or $2.96 per basic and diluted share compared with a net loss of $102.2 million or $3.55 per basic and diluted share in 2023.

2024 年第四季淨虧損為 3,750 萬美元，即每股基本虧損和稀釋虧損均為 0.80 美元，而 2023 年同期淨虧損為 2,600 萬美元，即每股基本虧損和稀釋虧損均為 0.72 美元。2024 年全年淨虧損為 1.269 億美元，即每股基本虧損和稀釋虧損均為 2.96 美元，而 2023 年淨虧損為 1.022 億美元，即每股基本虧損和稀釋虧損均為 3.55 美元。

Turning the forward guidance for 2025, the company expects full year 2025 JELMYTO revenues to be in the range of $94 million to $98 million. This implies a year over year growth rate of approximately 8% to 12% over the $87.4 million in demand-driven JELMYTO revenues in 2024, which excludes the $3 million in creates Act sales reported in 2024.

展望 2025 年，該公司預計 2025 年全年 JELMYTO 收入將在 9,400 萬美元至 9,800 萬美元之間。這意味著 2024 年 JELMYTO 的需求驅動收入將超過 8,740 萬美元，年成長率約為 8% 至 12%，其中還不包括 2024 年報告的 300 萬美元的《創造法案》銷售額。

Full year 2025 operating expenses are expected to be in the range of $215 million to $225 million including non-cash share-based compensation expense of $11million to $14 million.

預計 2025 年全年營運費用將在 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。

The anticipated increase in full year operating expenses is primarily driven by the planned salesforce expansion and additional commercial and medical activities to support the UGN-102 launch, as well as the advancement of our UGN-103 and UGN-104 clinical programs.

預計全年營運費用的成長主要由於計劃中的銷售團隊擴張和額外的商業和醫療活動，以支持 UGN-102 的推出，以及 UGN-103 和 UGN-104 臨床項目的推進。

We're now ready to open the call for questions, operator.

接線員，我們現在可以開始回答問題了。

(Operator Instructions)

（操作員指示）

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特（Tara Bancroft），TD Cowen。

Great, thanks. This is Nick on for Tara. You noted on the call that you anticipate approval in the recurrent setting. Do you anticipate that UGN-102 could still be used in the about 10% of patients or so that are ineligible for surgery, which would be the frontline setting, and would this then require it to be used off label? Thanks.

太好了，謝謝。這是尼克 (Nick) 代替塔拉 (Tara)。您在通話中指出，您期望在重複設定中獲得批准。您是否預計 UGN-102 仍可用於約 10% 不適合手術的患者（這將是前線設定），這是否需要將其用於標籤外用途？謝謝。

Yeah, hi Nick. It's Liz. Yeah, I think that would be considered off label, so clearly we wouldn't be able to promote there and I think it would be up to the physician to work with their insurance company because that's really what it comes down to is really more of a situation of making sure that they can get paid for it.

是的，你好，尼克。是莉茲。是的，我認為這會被視為標籤外用藥，所以顯然我們不能在那裡推廣，我認為這將取決於醫生與他們的保險公司的合作，因為這實際上更多的是一種確保他們能夠獲得報酬的情況。

So, as we've talked about before, we actually thought they might go there they did in the meeting and it was really driven by the fact that they always viewed that as being the unmet need and we it doesn't change our revenue projections and be really clear about that so we still believe that the medicine 102 will be over a billion dollars revenue.

因此，正如我們之前談到的，我們實際上認為他們可能會在會議上這樣做，這實際上是因為他們始終認為這是未滿足的需求，而且我們不會改變我們的收入預測，並且對此非常清楚，因此我們仍然相信藥物 102 的收入將超過 10 億美元。

And that doesn't change that and it never did. It was more of exactly what you're talking about, like we wanted physicians to have the ability for those few patients that they really don't want to put under because we all know that the newly diagnosed patients. They almost all of them get a TURBT for diagnostic purposes, but there are a handful of patients that physicians would just prefer not to put under.

但這並沒有改變事實，而且從來沒有改變過。這更像是您所說的，就像我們希望醫生能夠為那些他們真的不想接受治療的少數患者提供治療，因為我們都知道那些新診斷的患者。幾乎所有患者都會接受 TURBT 以進行診斷，但也有少數患者醫生不願意接受該手術。

Mark can comment, I think about what would happen. They usually do it anyway, right? And it's a little bit more risky, but, and physicians have told us they would like to be able to make that choice and not the FDA but it was clear in the conversation that we had with them.

馬克可以評論一下，我在想會發生什麼。他們通常都會這麼做，對吧？這確實有點冒險，但是，醫生告訴我們，他們希望能夠做出選擇，而不是 FDA，但在我們與他們的談話中，這一點很明顯。

And we had discussed it internally and knew that if they did go there, it's better for us, frankly, to go into the ODAC aligned with them on that so that we don't spend time in the ODAC, going back and forth on that and that we also don't risk, a vote because a negative vote because, panelists say, well, I don't want the newly diagnosed.

我們內部已經討論過這個問題，我們知道，如果他們真的去了那裡，坦率地說，我們最好和他們一起去 ODAC，這樣我們就不會在 ODAC 上浪費時間，來回爭論這個問題，我們也不會冒險投票，因為小組成員說，我不想要新診斷出的患者，所以投了反對票。

So this obviously makes it a smaller patient population but not really smaller from a business opportunity, but to your point, it would be up to the physician to work with the payer and the patient, for them to get reimbursed and we were obviously also, think about whether we should do some clinical work in this space or not, but it's a very small financial opportunity again just a matter of being able to help physicians make it easier for them to use.

因此，這顯然會使患者群體變小，但從商業機會來看並不會變小，但正如你所說，這取決於醫生與付款人和患者之間的合作，以便他們獲得報銷，我們顯然也在考慮是否應該在這個領域開展一些臨床工作，但這又是一個非常小的財務機會，僅僅是能夠幫助醫生更容易地使用它的問題。

It's very clear. Thank you very much.

非常清楚。非常感謝。

Thanks Nick.

謝謝尼克。

Michael Schmidt, Guggenheim.

古根漢美術館的麥可·施密特。

Hey, good morning. Thanks for taking our questions. On UGN-102 as you think about the potential SA approval later this summer in June, how should investors think about the initial launch trajectory, perhaps relative to JELMYTO or other potential benchmarks, are there any, analogs that, we should look at.

嘿，早安。感謝您回答我們的問題。關於 UGN-102，當您考慮今年夏天晚些時候（6 月）可能獲得的 SA 批准時，投資者應該如何看待初始發布軌跡，也許相對於 JELMYTO 或其他潛在基準，是否有任何類似物值得我們關注。

And then how should we think about pricing, again of one or two relatives to JELMYTO and would you expect any meaningful channel inventory built, early this year?

那麼，我們應該如何考慮與 JELMYTO 相關一兩個產品的定價？您是否預計今年年初會建立任何有意義的通路庫存？

Thanks for the question. I'll turn it over to David Lin, our Chief Commercial Officer, to answer those questions, David.

謝謝你的提問。我將把這個問題交給我們的首席商務官 David Lin 來回答，David。

Yeah, thanks for the question. In terms of launch trajectory, like we mentioned, we're going to continue educating our physician provider universe, and obviously maintaining a lot of support. So, the way we're thinking about, the overall shape of the curve is very akin to how we thought about JELMYTO, while the absolute numbers would be larger because of the patient population.

是的，謝謝你的提問。就發布軌跡而言，正如我們所提到的，我們將繼續教育我們的醫生提供者群體，並且顯然會保持大量的支持。因此，我們思考的方式是，曲線的整體形狀與我們對 JELMYTO 的思考非常相似，但由於患者人數眾多，絕對數字會更大。

The overall shape we are, modeling very similar to that of JELMYTO because there's a lot of similarities in terms of the operational, considerations. On your question with regard to pricing, I think we continue to think of pricing in the $1800 to $19,000 per dose. However, we continue to do research with payers to refine our assumptions and but that's how we're thinking about it for right now.

我們的整體造型、造型與JELMYTO非常相似，因為在操作、考慮方面有很多相似之處。關於您提出的定價問題，我認為我們繼續考慮將價格定在每劑 1800 美元至 19,000 美元之間。然而，我們會繼續與付款人進行研究，以完善我們的假設，但這就是我們目前的想法。

Great, thank you.

太好了，謝謝。

Raghuram Selvaraju, H. C. Wainwright.

Raghuram Selvaraju，H.C.溫賴特。

Thanks so much for taking our questions. Firstly, with respect to UGN-102 and the projected reimbursement environment, I was just wondering if you could maybe provide us with additional granularity regarding the difference in reimbursement level and degree of market access that you expect to have during the period immediately after launch when you will have the generic J-code and once you actually have the specific J-code in January of 2026.

非常感謝您回答我們的問題。首先，關於 UGN-102 和預計的報銷環境，我只是想知道您是否可以為我們提供更多詳細信息，說明您預計在推出後立即擁有通用 J 代碼的期間內以及在 2026 年 1 月真正擁有特定 J 代碼後的報銷水平和市場准入程度的差異。

Just kind of spell out for us how the environment is going to change when you shift from one J-code to another. And then secondly with regard to the pipeline development activities, can you give us some update on how enrollment kinetics appear to be progressing in the UGN-103 program and if you still expect to be in a position to report data from that trial either next year or in 2027? Thank you.

只要向我們說明一下，當你從一個 J 程式碼轉換到另一個 J 程式碼時環境將如何變化。其次，關於管道開發活動，您能否向我們介紹 UGN-103 計劃的入組動力學進展情況，以及您是否仍預計明年或 2027 年能夠報告該試驗的數據？謝謝。

Yeah, great question. So, I'll ask David to answer the first question around reimbursement and then move to Mark to give you an update on EGN-103 and timing. So, David.

是的，很好的問題。因此，我會請 David 回答有關報銷的第一個問題，然後請 Mark 向您提供有關 EGN-103 和時間安排的最新情況。那麼，大衛。

Yeah, thanks again for the question there. From a reimbursement perspective, as we stated in the initial six months, assuming the June 13, action date, we do anticipate a miscellaneous J-code being used. Essentially what this means from an assumption standpoint is that the overall reimbursement process we believe takes a little bit longer.

是的，再次感謝您的提問。從報銷角度來看，正如我們在最初六個月中所述，假設行動日期為 6 月 13 日，我們確實預期會使用雜項 J 代碼。從假設的角度來看，這實際上意味著我們認為整個報銷過程需要更長的時間。

So somewhere around the 50 to 60 days for a provider to be reimbursed, and that number does cut down by about half when we have a unique permanent miscellaneous J-code which we assume will be in the January 2026 time frame. So our real focus is going to be making sure that we are with our accounts supporting them in the coding and reimbursement process to guide them through that initial period and so we would continue to provide the same level of support as we are now just to a broader audience.

因此，大約需要 50 到 60 天的時間才能讓提供者獲得報銷，而當我們擁有一個獨特的永久性雜項 J 代碼時，這個數字確實會減少一半左右，我們假設這個代碼將在 2026 年 1 月的時間範圍內實現。因此，我們真正的重點是確保我們的帳戶在編碼和報銷過程中為他們提供支持，以指導他們度過初始階段，因此我們將繼續為更廣泛的受眾提供與現在相同級別的支持。

Well, let me, I just want to add a couple things that we will have services to get physicians through that time period. So like we did with JELMYTO, we'll have a longer dating so they don't have to put the money out before they get reimbursed, as well as the hub.

好吧，我只想補充幾點，我們將提供服務來幫助醫生度過那段時期。因此，就像我們與 JELMYTO 合作一樣，我們會延長合作期限，這樣他們就不必在獲得報銷之前先把錢拿出來，中心也是如此。

And the other thing that I'll comment on is, we also expect, like we saw with JELMYTO that the initial uptake from a site of care perspective will be more in the hospital and the institutions, because the pharmacy takes the risk at that point in time and not the private practice.

我要評論的另一件事是，我們也預計，就像我們在 JELMYTO 中看到的那樣，從護理場所的角度來看，最初的採用將更多地在醫院和機構中進行，因為藥房在那個時間點承擔風險，而不是私人診所。

So where the J-code becomes, more challenging is really the private practices who are concerned about putting out that kind of money and taking the risk of not being reimbursed. So we expect those physicians would just take their patient to the hospital or the institution in which they're affiliated and they would conduct the therapy at that place.

因此，當 J 代碼生效時，私人診所面臨的挑戰更大，他們擔心花費大量資金並承擔無法獲得報銷的風險。因此，我們希望這些醫生能夠將病人帶到他們所屬的醫院或機構，並在那裡進行治療。

So again, as we mentioned earlier, as David mentioned earlier, I think you can look at JELMYTO in the initial couple of first, 18 months. I would not look at JELMYTO post those 18 months because we do believe that that the opportunity is far greater for UGN-102, and we should see an acceleration that's greater than we see with JELMYTO.

所以，正如我們之前提到的，正如 David 之前提到的，我認為您可以在最初的 18 個月內看到 JELMYTO。我不會在 18 個月後關注 JELMYTO，因為我們確實相信 UGN-102 的機會要大得多，我們應該會看到比 JELMYTO 更大的加速度。

But the first couple of years of JELMYTO, if you see in our first year we sold $15 million around the same six months, around almost $15 million in revenue and then it went up to almost $50 million in the in the full year, following, so I would use that as a good analog for the first 18 months. So hopefully that helps.

但在 JELMYTO 成立後的頭幾年，如果你看到我們第一年在大約六個月內銷售額為 1500 萬美元，收入約為 1500 萬美元，然後在全年增長到近 5000 萬美元，因此，我會用它作為前 18 個月的一個很好的類比。希望這能有所幫助。

Well, what I would also mention, of course, is for those who remember you launched JELMYTO in the middle of a pandemic and that will clearly not be the case with 102.

當然，我還想提一下，對於那些記得你們在疫情期間推出 JELMYTO 的人來說，102 顯然不會出現這種情況。

Exactly, absolutely, but like if you just take into consideration, and I'm not suggesting the same amount of revenue, but if to David's point earlier, it's a much bigger patient population, the price may be, a little bit less, but you can See At 10 times the size, even if JELMYTO were the analog, it it'd still be a very positive for the first few months, of our of the launch.

確實如此，絕對如此，但如果你只是考慮到，我並不是建議相同的收入數額，但如果按照 David 之前的觀點，患者群體要大得多，價格可能會稍微低一點，但你可以看到，即使 JELMYTO 是類似物，規模擴大 10 倍，在我們推出後的頭幾個月裡，它仍然會是非常積極的。

But you're absolutely right, we launched into a pandemic and hopefully knock on wood, everybody, we won't be having a pandemic in 2025 and 2026. So, thanks for the question and the comment as well. And then I'll turn it over to Mark to answer the question on 103, Mark.

但您說得完全正確，我們已經陷入了一場大流行，希望各位，我們在 2025 年和 2026 年不會再經歷一場大流行。所以，也感謝您的提問與評論。然後我將把問題 103 交給馬克回答，馬克。

Yeah, thanks, Liz. With respect to 103 and the trial is the UTOPIA trial, we're anticipating complete enrolment this year, data in '26 and approval in '27, so it's sort of a lockstep progression, but things are going well and we're very optimistic that we're going to be able to keep to that timeline.

是的，謝謝，莉茲。對於 103 和 UTOPIA 試驗，我們預計今年將完成招募，26 年獲得數據，27 年獲得批准，因此這是一種步調一致的進展，但一切進展順利，我們非常樂觀地認為我們將能夠遵守這個時間表。

Thank you very much.

非常感謝。

Leland Gershell, Oppenheimer.

利蘭·格謝爾，奧本海默。

Good morning and thanks for the update and taking our questions. Just one from us, just teeing off the earlier question about examining, treatment naive, patients with low grade, just wondering if you get the ongoing trial with 103 if you would look to possibly amend that or if you would look to do further study in treatment naive for the benefit of 103's eventual label. Thank You.

早安，感謝您的更新和回答我們的問題。我們只想問一個問題，關於檢查未經治療的低級別患者，我只是想知道，如果您參加了 103 的持續試驗，您是否會考慮修改它，或者您是否會考慮對未經治療的患者進行進一步研究，以獲得 103 的最終標籤。謝謝。

Yeah, it's a great question, Leland, and to be honest with you, this just happened last week, so we haven't spent a lot of time thinking about it. I think at the end of the day it would more likely be around generating data in real world use, maybe like a registry or through an IIR.

是的，這是一個很好的問題，利蘭，老實說，這件事上週才發生，所以我們還沒有花很多時間去思考它。我認為最終它更有可能圍繞在現實世界中使用生成數據，可能像註冊表或通過 IIR。

But, because as I mentioned, the opportunity is fairly small, although the good news with UGN-103 is that we would be moving to our patent protection on that medicine will be until through 2041. So, we have a lot of time. So, I think we would take a look at it, but no, we would not amend the current 103, and the reason we would not amend the 103 is because we need to keep that study as close to UGN-102 as possible.

但是，正如我所提到的，機會相當小，儘管 UGN-103 的好消息是我們將轉向對該藥物的專利保護，直到 2041 年。所以，我們有很多時間。所以，我認為我們會看一下，但不，我們不會修改目前的 103，我們不會修改 103 的原因是因為我們需要讓研究盡可能接近 UGN-102。

So that because that's what they'll be using as a comparison, right? So, to get that drug approved and approved quickly, they'll be using UGN-102. So, you want to keep that study as quickly as possible, but we'll evaluate UGN-103 just like where you've been talking about, we'll move 103 into high grade disease. We'll look at other areas where we can study UGN-103.

因為他們將用它作為比較，對嗎？因此，為了使該藥物獲得批准並快速獲得批准，他們將使用 UGN-102。因此，您希望盡快保留該研究，但我們會評估 UGN-103，就像您一直在談論的那樣，我們將 103 轉移到高級疾病中。我們將研究可以研究 UGN-103 的其他領域。

There may be other, and it may be not just in the newly diagnosed intermediate risk, but there may be a population, the unwilling and unable population which is actually broader than just the intermediate risk. And that's something that I've been wanting to do for the last few years.

可能還有其他情況，可能不只是新診斷出的中度風險族群，還可能有不願意和不能的人群，這實際上比中度風險族群的範圍更廣。這也是我過去幾年一直想做的事。

So maybe we take an opportunity to do that and that would include newly diagnosed across a broader spectrum of patients that physicians just don't, want to or patients don't want to go to surgery. But it's a great question. We'll have to give it some more thought from that perspective.

因此，也許我們可以藉此機會做到這一點，其中包括更廣泛的新診斷患者，而醫生不想或患者不想接受手術。但這是一個很好的問題。我們必須從這個角度進一步考慮。

Thanks, I'll just actually slip in a quick second just in terms of the pipeline, following the recent update on ICVB-1042 and other collaborative agreements, just wondering if you have any plans to share more, their either data or more about the collaborations in 2025 and also 301 if we might see more reveal from that ongoing development. Thank you.

謝謝，實際上，我只想快速地問一下關於管道的問題，根據最近關於 ICVB-1042 和其他合作協議的更新，我只是想知道您是否有計劃分享更多信息，無論是他們的數據還是有關 2025 年合作的更多信息，以及 301，如果我們可以從正在進行的開發中看到更多揭示。謝謝。

Yeah, quite great question. On the collaborations, I think we will wait till we see some data, some feasibility data, these early studies, they're really the first question is can you put the drug in the gel? Does it work? Does it provide the benefit that we think it does, so we'll do some pre-clinical work there.

是的，這個問題問得非常好。關於合作，我認為我們會等到看到一些數據、一些可行性數據，這些早期的研究，他們真正的第一個問題是，你能把藥物放進凝膠裡嗎？它有用嗎？它是否提供了我們認為的益處，所以我們將在那裡做一些臨床前工作。

But absolutely if that moves forward, we will share that. And then Mark, do you just want to give an update on what we expect that we'll see this year for UGN-301 and 1042.

但如果事情有進展，我們絕對會分享。然後馬克，您是否想更新我們對今年 UGN-301 和 1042 的預期情況？

Yeah, thanks. So, with respect to 1042 this year is IND enabling studies, so we'll be focused on that formulation, et cetera. And obviously, we have notable output from that, we would share that, but as Liz points out, it'll probably be next year before we have substantive data to share, and it's early in that program.

是的，謝謝。因此，就 1042 而言，今年是 IND 支持研究，因此我們將重點放在該配方等等。顯然，我們在這方面取得了顯著的成果，我們會分享這些成果，但正如 Liz 指出的那樣，可能要到明年我們才能有實質性的數據可以分享，而且現在還處於該計劃的早期階段。

With respect to 301, we did announce the monotherapy data at the SUO this past year. We actually, as everyone knows, have combination arms in that trial, which is a Phase 1 trial combining 301 with our TLR7 agonist 201, as well as with gemcitabine.

關於 301，我們確實在去年在 SUO 公佈了單一療法數據。眾所周知，我們實際上在該試驗中設有聯合治療組，這是將 301 與我們的 TLR7 激動劑 201 以及吉西他濱相結合的 1 期試驗。

We have seen some interesting data with respect to responses. Again, it's a Phase 1 trial, but we are following those patients for the durability of those responses and anticipate reporting that later this year.

我們看到了一些與回應有關的有趣數據。再次強調，這是第一階段試驗，但我們正在追蹤這些患者的反應的持久性，並預計在今年稍後報告結果。

Super, thanks very much.

非常好，非常感謝。

Paul Choi, Goldman Sachs.

高盛的保羅·崔（Paul Choi）。

Hi, thank you, good morning and thanks for taking our questions. I want to revisit pricing for 102 for a moment and I just want to ask, given the, impressive durability that the ENVISION data has shown, relative to the, total all in cost for repeat TURBTs, have you sort of stress tested maybe, potentially higher pricing and just sort of your pair reactions on this for 102 here, just again given the durability and potential, longer term reduction in costs any color there would be great.

嗨，謝謝，早上好，感謝您回答我們的問題。我想重新討論一下 102 的定價，我只想問一下，鑑於 ENVISION 數據顯示的令人印象深刻的耐用性，相對於重複 TURBT 的總成本，您是否對潛在的更高定價進行過壓力測試，並且您對 102 的反應是，再次考慮到耐用性和潛力，長期降低成本，任何顏色都會很棒。

And second, with 103 potentially launching as early as 2027, can you comment on how you're thinking about positioning 102 versus 103, would there be a switch strategy, or would you just, sort of fade out 102 in favor of 103 given the longer IP considerations there and just. How you're thinking about the potential return on 102 if you do think about a switch strategy? Thank you very much.

其次，由於 103 可能最早在 2027 年推出，您能否評論一下您如何考慮將 102 與 103 進行定位，是否會有一個轉換策略，或者您是否會因為更長遠的 IP 考慮而淡出 102 而支援 103。如果您確實考慮轉換策略，您如何看待 102 的潛在回報？非常感謝。

Yeah, great questions, Paul, and I can tell you that we are revisiting. We had already there's research underway because the pricing research we had done was before the impressive data to your point, durability data so we are looking at that and we do believe that there's an opportunity to increase that slightly, so we will definitely be looking at that and I'm sorry, your second question remind me again.

是的，保羅，這個問題問得很好，我可以告訴你，我們正在重新討論這個問題。我們已經在進行研究，因為我們所做的定價研究是在您提到的令人印象深刻的數據、耐用性數據之前進行的，所以我們正在研究這一點，我們確實相信有機會稍微提高這一點，所以我們一定會研究這一點，很抱歉，您的第二個問題再次提醒我。

Yes, sure, Liz, just how you're thinking about positioning 103 versus 102 apart from IP and just, are you going to fade it out 102 out, and just how you're thinking about the potential return profile for 102 if you do switch to 103?

是的，當然，Liz，除了 IP 之外，您是如何考慮將 103 與 102 進行定位的，您是否會將其淡出 102，如果您確實切換到 103，您如何考慮 102 的潛在回報概況？

Yeah, no, absolutely sorry, but yes, what we would do is we would as soon as 103 is approved we would likely wait for the J-code right to get so there's no concern about reimbursement. But then after that we would actually fade out UGN-102 and we would take UGN-102 off the market and shift all of that, the business to UGN-103.

是的，不，非常抱歉，但是是的，我們會做的是，一旦 103 獲得批准，我們可能會等待 J 代碼權利，這樣就不必擔心報銷。但在那之後，我們實際上會逐漸淘汰 UGN-102，並將 UGN-102 撤出市場，將所有業務轉移到 UGN-103。

And that what that provides us is that is that 102 won't be on the market so there won't be any automatic substitution or there won't be interchangeability. So if a generic or someone came in at post 2031, they would actually have to promote the product, and the doctor would actually have to write for their specific product.

這給我們帶來的是，102 將不會出現在市場上，因此不會有任何自動替代或互換性。因此，如果在 2031 年後出現仿製藥或新藥，他們實際上必須推廣該產品，而醫生實際上必須為他們的特定產品撰寫文章。

So it wouldn't be a 102 for them to write and again it'd be interchangeable. In addition to that, I don't know if anyone saw but we had the product specific guidance came out in November around JELMYTO and the guidance says that they have to demonstrate that it is identical, not equivalent but identical. And I think that raises the bar for anyone to come in regardless of whether 102 is on the market or not.

因此他們不需要寫 102，而且可以互換。除此之外，我不知道是否有人看到，但我們在 11 月發布了有關 JELMYTO 的產品特定指南，該指南指出他們必須證明它是相同的，不是等效而是相同。我認為這提高了任何人進入的門檻，無論 102 是否在市場上。

And we're obviously just shifting the information that we have for JELMYTO to UGN-102, because JELMYTO is the only one right now that you know that generics have, obviously since 102 isn't on the market. But again 102 would not be on the market for the generic companies to be able to compare to. So, I hope that helps.

顯然，我們只是將有關 JELMYTO 的資訊轉移到 UGN-102，因為 JELMYTO 是目前唯一一種仿製藥所擁有的藥物，顯然是因為 102 還沒有上市。但 102 不會再次出現在市場上，供仿製藥公司進行比較。所以，我希望這會有所幫助。

Got it. Okay, thank you very much.

知道了。好的，非常感謝。

Thanks Paul.

謝謝保羅。

Aydin Huseynov, Ladenburg.

拉登堡的艾登‧胡賽諾夫 (Aydin Huseynov)。

Hi, good morning, everyone. Thank you for taking questions and congrats for the progress this quarter. Question I have is regarding the preparedness, commercial preparedness, and infrastructure. So, I think you mentioned the increase of reps from 52 to 83, and your current reps obviously selling JELMYTO, making $100 million and potentially, UGN-102, I think your guidance a $1 billion in the peak sales.

大家好，早安。感謝您回答問題，並祝賀本季的進展。我的問題是關於準備、商業準備和基礎設施。所以，我認為您提到了銷售代表從 52 人增加到 83 人，而您目前的銷售代表顯然在銷售 JELMYTO，賺了 1 億美元，而且可能還有 UGN-102，我認為您的指導峰值銷售額是 10 億美元。

So, can you help us understand the sort of economies of scale of increasing from 52 to 83 given that it's actually 10 times more potential pixels, so maybe you can help us understand this from commercial preparedness perspective.

那麼，您能否幫助我們理解從 52 增加到 83 的規模經濟，因為實際上潛在像素增加了 10 倍，所以也許您可以從商業準備的角度幫助我們理解這一點。

Sure, absolutely. David, do you want to comment on that and why we feel like the 83 is an appropriate number even despite the fact that it's a, it's obviously a much, bigger opportunity.

當然，絕對是如此。大衛，你想對此發表評論嗎？為什麼我們覺得 83 是一個合適的數字，儘管這顯然是一個更大的機會。

Yeah, that's a great question. So our, analysis to increase the size of our commercial footprint from about 52 territories to around 83 territories is really hinged on the patient epidemiology and one important thing to note is that with JELMYTO and the low grade UTUC, with something like 6,000 patients in a year that might present, the likelihood of any one neurologist seeing more than one of these is fairly uncommon.

是的，這是一個很好的問題。因此，我們將商業足跡從約 52 個地區擴大到約 83 個地區的分析實際上取決於患者流行病學，需要注意的一件重要事情是，對於 JELMYTO 和低級別 UTUC，每年可能有 6,000 名患者出現，任何一位神經科醫生看到其中一位以上患者的可能性相當罕見。

In the case of low-grade intermediate risk NMIBC, what we hear from customers is that they are seeing, they know who these patients are, and the vast majority of urology practices do see these patients. And so the sizing of 83 territories allows us to get to the vast majority of treating physicians and practices. So it's something like 80% roughly 85% of the market's covered, so we are really hitting the sweet spot in.

對於低度中度風險 NMIBC 的情況，我們從客戶那裡聽到的是，他們正在看病，他們知道這些病人是誰，而且絕大多數泌尿科診所確實會看這些病人。因此，83 個地區的規模使我們能夠接觸到絕大多數的治療醫生和實踐。因此，我們的市場覆蓋率約為 80% 到 85%，因此我們確實達到了最佳水平。

Learning from our experiences with JELMYTO in that frequency of our visits does make a difference and so we're increasing that and importantly, the patients are in these practices. So we feel very good about the size of our commercial footprint going forward and it will allow us to see and provide the comprehensive service that we know is required to help them get these patients started and through therapy.

從我們在 JELMYTO 的經驗中，我們了解到我們的就診頻率確實有所不同，因此我們正在增加就診頻率，而且重要的是，患者也參與了這些實踐。因此，我們對未來的商業足跡規模感到非常滿意，它將使我們能夠看到並提供我們所知道的全面服務，以幫助這些患者開始並完成治療。

Yeah, and the only thing I'll add is that in addition to the 83 reps, as David talked about, we have nurse educators, we have medical science liaisons for peer to peer, we have operations managers to help with the operational and logistics pieces of it, and we've got account directors and field reimbursement managers.

是的，我唯一要補充的是，除了 83 名代表之外，正如 David 談到的，我們還有護理教育者、同行醫學科學聯絡員、營運經理來幫助處理營運和物流部分，我們還有客戶總監和現場報銷經理。

So it's not just the 83, it's these other roles that we have found to be very critical in the really comprehensive support system for physician offices. So given the entire field organization is much greater than 83, we feel really good about the number and where we are.

因此，我們發現，不僅僅是這 83 個角色，這些其他角色在真正全面的醫生辦公室支援系統中也至關重要。因此，考慮到整個現場組織的數量遠遠超過 83 個，我們對這個數字以及我們所處的位置感到非常滿意。

Thank you, thanks so much.

謝謝，非常感謝。

Thank you.

謝謝。

Thank you, and I'm showing no further questions at this time, and I would like to hand the conference back to Liz Barrett for any further remarks.

謝謝，我現在沒有其他問題了，我想將會議交還給利茲·巴雷特 (Liz Barrett)，以便做出進一步的評論。

Great, thanks to everybody. Just want to say thank you. It's been a very busy year in 2024. We've already turned the page in 2025, will be the most transformational year for our company.

太好了，謝謝大家。我只想說聲謝謝。2024年是非常忙碌的一年。我們已經翻開了2025年的新篇章，這將是我們公司最具變革性的一年。

We're excited about the opportunity for UGN-102 to bring that to patients and we look forward to providing more updates as things happen throughout the year. So, I appreciate everyone joining. We can disconnect now. Thank you.

我們很高興 UGN-102 有機會為患者帶來這種益處，我們期待在全年的發展過程中提供更多更新資訊。因此，我感謝大家的加入。我們現在可以斷開連線。謝謝。

This concludes today's conference call. Thank you for participating and you may now disconnect. Everyone have a great day.

今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接。祝大家有個愉快的一天。