Urogen Pharma Ltd (URGN) 2023 Q4 法說會逐字稿

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the UroGen Pharma full-year 2023 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 begin.

早安，女士們，先生們。感謝您的支持，歡迎參加 UroGen Pharma 2023 年全年財報電話會議。請注意，今天的會議正在錄製中，我現在想將會議交給今天的發言人，投資者關係主管 Vincent Perrone。你可以開始了。

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma's full-year 2023 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter and year ended December 31, 2023.

謝謝你，接線生。大家早安，歡迎參加 UroGen Pharma 2023 年全年財務業績和業務更新電話會議。今天早些時候，我們發布了一份新聞稿，概述了我們最近的公司亮點以及截至 2023 年 12 月 31 日的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, our President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; Jeff Bova, our Chief Commercial Officer; and Don Kim, Chief Financial Officer.

您可以在我們網站的投資者部分訪問該新聞稿：investors.urogen.com。今天和我一起參加電話會議的是我們的總裁兼執行長 Liz Barrett；馬克‧勳伯格博士，首席醫療官； Jeff Bova，我們的商務長；和財務長 Don Kim。

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 projections and opportunities; our commercialization strategy and expectation, as well as potential future commercialization activities for UGN-102, if approved; anticipated data, regulatory filings, and decisions, including UGN-102 potentially receiving priority review, UGN-102 being transformative, and the major growth driver for UroGen if approved; future research and development efforts for UGN-103, UGN-104 and UGN-301; our corporate goals; and 2024 financial guidance among other things.

在今天的電話會議中，我們將做出某些前瞻性聲明。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的臨床試驗的聲明；商業和臨床里程碑；市場和收入預測及機會；我們的商業化策略和期望，以及 UGN-102 未來潛在的商業化活動（如果獲得批准）；預期數據、監管備案和決定，包括 UGN-102 可能獲得優先審查、UGN-102 具有變革性，以及 UroGen 如果獲得批准將成為主要成長動力； UGN-103、UGN-104 和 UGN-301 的未來研發工作；我們的企業目標；以及 2024 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. You are cautioned not to place undue reliance on these forward-looking statements and UroGen disclaims any obligation to update these statements.

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

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

我現在將把電話轉給莉茲。麗茲？

Thanks, Vincent, and thank you to everyone joining us this morning. 2023 was a very successful year for UroGen, laying the groundwork for progress and growth in the years ahead. The Phase 3 ATLAS and ENVISION trials evaluating our lead development candidate, UGN-102, both met their primary endpoints. The data underscore the potential of UGN-102 to be a transformational product and to advance the standard of care in low-grade intermediate risk non-muscle invasive bladder cancer.

謝謝文森特，也謝謝今天早上加入我們的所有人。 2023 年對於 UroGen 來說是非常成功的一年，為未來幾年的進步和成長奠定了基礎。評估我們的主要開發候選藥物 UGN-102 的 3 期 ATLAS 和 ENVISION 試驗均達到了主要終點。這些數據強調了 UGN-102 成為變革性產品並提高低度中危非肌肉層浸潤性膀胱癌護理標準的潛力。

We have started the regulatory submission process and believe that, if approved, UGN-102 will be the major growth driver for our company. We see a great opportunity to improve the lives of patients and create value for our stakeholders.

我們已經啟動了監管提交程序，相信如果獲得批准，UGN-102將成為我們公司的主要成長動力。我們看到了改善患者生活並為利害關係人創造價值的絕佳機會。

Meanwhile, our existing commercial product, JELMYTO, continues to enjoy double-digit growth and positive adoption trends. The current clinical development plan for UGN-102 was agreed with the FDA in a pre-NDA meeting that was held in late 2023. The FDA confirmed that the current clinical development plan for UGN-102, which includes evaluation of duration of complete response data at 12 months from the pivotal ENVISION trial, will support submission of an NDA for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer.

同時，我們現有的商業產品 JELMYTO 持續保持兩位數的成長和正面的採用趨勢。UGN-102 目前的臨床開發計劃在 2023 年底舉行的 NDA 前會議上與 FDA 達成協議。FDA 確認 UGN-102 目前的臨床開發計劃，包括對關鍵 ENVISION 試驗後 12 個月的完全緩解數據持續時間的評估，將支持提交用於治療低度中度風險非肌肉疾病的新藥申請 (NDA)。浸潤性膀胱癌。

We announced in January this year that we had submitted the chemistry manufacturing and controls, our CMC modules of this application. The objective of a rolling NDA is to facilitate early engagement with the agency and potentially allow for more efficient and timely review of the application.

我們在今年一月份宣布，我們已經提交了化學製造和控制，即該申請的 CMC 模組。滾動 NDA 的目的是促進與該機構的早期接觸，並有可能更有效、更及時地審查申請。

We plan to share the data on the duration of response endpoint from ENVISION in June of this year. Assuming the data is as expected, we will complete submission of the NDA late in the third quarter. If granted priority review, we anticipate approval and launch of UGN-102 as early as the first quarter of 2025.

我們計劃在今年 6 月分享 ENVISION 回應端點持續時間的數據。假設數據符合預期，我們將在第三季末完成 NDA 的提交。如果獲得優先審查，我們預計 UGN-102 最早將於 2025 年第一季獲得批准並上市。

The commercial opportunity in low-grade intermediate risk non-muscle invasive bladder cancer is significant. We estimate that approximately 82,000 patients are eligible each year in the US. So the overall market is around 10 times the size of the urothelial carcinoma market that JELMYTO currently addresses. This translates into a total market in excess of $3 billion and over a $1 billion revenue opportunity for UGN-102 when using conservative assumptions.

低度、中度風險的非肌肉層浸潤性膀胱癌的商業機會是巨大的。我們估計美國每年約有 82,000 名患者符合資格。因此，整體市場規模約為 JELMYTO 目前針對的尿路上皮癌市場規模的 10 倍。如果使用保守假設，這意味著 UGN-102 的總市場超過 30 億美元，收入機會超過 10 億美元。

We also announced in January that we entered into a strategic license and supply agreement with medac to develop a next-generation novel mitomycin-based RTGel formulations of JELMYTO in UGN-102. Through this agreement, we are combining our proprietary RTGel with medac's proprietary formulation of mitomycin.

我們也在 1 月宣布與 medac 簽訂策略許可和供應協議，以開發 UGN-102 中的 JELMYTO 的下一代新型基於絲裂黴素的 RTGel 製劑。透過這項協議，我們將我們的專有 RTGel 與 medac 的絲裂黴素專有配方結合。

Our next-generation products are anticipated to provide advantages in terms of production, manufacturing, efficiency, supply and product convenience. Importantly, the program could provide additional patent protection for our urothelial cancer franchise.

我們的下一代產品預計將在生產、製造、效率、供應和產品便利性方面提供優勢。重要的是，該計劃可以為我們的尿路上皮癌專營權提供額外的專利保護。

Medac has issued IP with protection expected to last until 2035, and UroGen has separate pending US patent applications that, if granted, could provide protection until December of 2041. We will need to conduct clinical endpoint studies to support NDAs for UGN-103 and for UGN-104, our next generation formulation of JELMYTO. Importantly, this will be a smaller development program and we intend to move directly into Phase 3 for both products beginning in 2024.

Medac 已發布智慧財產權，保護期預計將持續到 2035 年，而 UroGen 也有單獨的待審美國專利申請，如果獲得批准，可以提供保護到 2041 年 12 月。我們需要進行臨床終點研究，以支持 UGN-103 和 UGN-104（我們的下一代 JELMYTO 製劑）的 NDA。重要的是，這將是一個較小的開發計劃，我們打算從 2024 年開始直接進入這兩種產品的第三階段。

Turning to JELMYTO revenue, the product achieved sales of $23.5 million in Q4 and $82.7 million for the full-year 2023. Reflected in this number are some non-patient cells. We have also seen an increase in gross to net deductions. But most importantly, patient demand drivers remain strong, with patient enrollment forms, new patient starts, and doses -- all achieving approximately 25% growth for the year. Jeff will provide additional details in a few minutes.

談到 JELMYTO 的收入，該產品第四季的銷售額為 2,350 萬美元，2023 年全年銷售額為 8,270 萬美元。這個數字反映了一些非患者細胞。我們也看到總扣除額與淨扣除額的增加。但最重要的是，患者需求驅動因素仍然強勁，患者登記表、新患者開始數量和劑量——今年均實現了約 25% 的增長。傑夫將在幾分鐘內提供更多詳細資訊。

As we look toward long-term growth, it is critical that we maintain a strong balance sheet and the ability to expand our patient impact through lifecycle management and development of new medicines to treat urothelial and specialty cancers. We are pleased to announce our expanded partnership with Pharmakon Advisors, providing us with additional funding of up to $100 million.

當我們著眼於長期成長時，保持強勁的資產負債表以及透過生命週期管理和開發治療尿路上皮癌和特殊癌症的新藥來擴大患者影響的能力至關重要。我們很高興地宣布擴大與 Pharmakon Advisors 的合作夥伴關係，為我們提供高達 1 億美元的額外資金。

As part of the agreement, we are required to draw down on the first tranche a $25 million by September 30, with the option to draw up to an additional $75 million following UGN-102 approval if needed. The benefits of this agreement are that we now have an additional source of capital with flexibility on the amount we utilize. We have enjoyed a productive and collaborative partnership with Pharmakon Advisors and look forward to closely working with them in the future.

作為協議的一部分，我們需要在 9 月 30 日之前提取第一筆款項 2500 萬美元，如果需要，可以選擇在 UGN-102 獲得批准後額外提取最多 7500 萬美元。該協議的好處是，我們現在有了額外的資金來源，並且可以靈活地使用金額。我們與 Pharmakon Advisors 建立了富有成效的合作夥伴關係，並期待未來與他們密切合作。

With our current cash balance and approximately $25 million recently sourced from the ATM, we expect to have the capital to execute a comprehensive launch for UGN-102, if approved and fund new potential clinical studies.

憑藉我們目前的現金餘額和最近從 ATM 獲得的約 2500 萬美元，如果獲得批准並資助新的潛在臨床研究，我們預計將有資金執行 UGN-102 的全面啟動。

I will now turn the call over to Mark Schoenberg, our Chief Commercial Officer. Mark?

我現在將把電話轉給我們的首席商務官馬克·勳伯格。標記？

Thank you, Liz. We have the opportunity to share the Phase 3 ATLAS and ENVISION data with the physician community at the Society of Urologic Oncology Annual Meeting, which took place in November. We were especially pleased that the SUO selected the ENVISION data as one of only two late-breaking trials that were designated for oral presentation at this meeting.

謝謝你，莉茲。我們有機會在 11 月舉行的泌尿腫瘤學會年會上與醫師界分享 3 期 ATLAS 和 ENVISION 數據。我們特別高興的是，SUO 選擇 ENVISION 數據作為僅有的兩項指定在本次會議上進行口頭報告的最新試驗之一。

Looking at the body of clinical data we have generated, UGN-102 has demonstrated consistency in the three-month complete response rate across ATLAS and ENVISION as well as our prior Phase 2b OPTIMA to study. The complete response rates observed in these three studies were 65%, 79%, and 65% respectively.

從我們產生的臨床數據來看，UGN-102 在 ATLAS 和 ENVISION 以及我們先前研究的 2b 期 OPTIMA 中的三個月完全緩解率表現出一致性。這三項研究中觀察到的完全緩解率分別為 65%、79% 和 65%。

Moreover, ATLAS data suggest UGN-102 appears to be superior to surgery once the complete response has been achieved. In the ATLAS study, 80% of patients who received UGN-102 experienced the duration of response to 12 months compared to only 68% of those patients who had a TURBT alone.

此外，ATLAS 數據表明，一旦獲得完全緩解，UGN-102 似乎優於手術。在 ATLAS 研究中，接受 UGN-102 治療的患者中有 80% 的緩解持續時間長達 12 個月，而僅接受 TURBT 治療的患者中這一比例僅為 68%。

We believe that the ability of UGN-102 to achieve high complete response rates non-surgically and to potentially extend disease-free living will ultimately minimize the need for multiple surgeries in this patient population. The average age for diagnosis of bladder cancer is in the mid-70s. Many of these patients have comorbidities that highlight the need for nonsurgical treatment alternatives to the contemporary standard of care, TURBT.

我們相信 UGN-102 能夠實現非手術的高完全緩解率並有可能延長無病生活，最終將最大限度地減少該患者群體的多次手術需求。膀胱癌的平均診斷年齡為 70 多歲。這些患者中的許多人都患有合併症，這凸顯了對現代護理標準 TURBT 的非手術治療替代方案的需求。

UGN-102 has the unique advantage of being easy to administer. Patients can be treated in their urologist's office without the need of an OR and all the disruption to daily life associated with surgery. As Liz mentioned, the next milestone in this program will be the secondary endpoint of 12-month duration of response data from ENVISION.

UGN-102具有易於管理的獨特優勢。患者可以在泌尿科醫師的辦公室接受治療，無需手術室，也無需與手術相關的日常生活中斷。正如 Liz 所提到的，該計劃的下一個里程碑將是 ENVISION 的 12 個月回應資料持續時間的次要終點。

Different from the ATLAS data, ENVISION consisted solely of recurrent patients that had received at least one TURBT. If we look at the comparable subgroup of recurrent patients in ATLAS, the 12-month duration of response was 66%.

與 ATLAS 數據不同，ENVISION 僅由接受至少一次 TURBT 的複發患者組成。如果我們觀察 ATLAS 中復發患者的可比亞組，12 個月的緩解持續時間為 66%。

The Phase 2b OPTIMA study projected a 12-month duration of response in the high 50s. As we have consistently communicated, we expect the ENVISION data to show a duration of response at 12 months at least 50% or higher, and we believe this is clinically meaningful and will be an improvement over the current standard of care.

2b 期 OPTIMA 研究預計 12 個月的反應持續時間在 50 多歲左右。正如我們一直以來所傳達的那樣，我們預計 ENVISION 數據顯示 12 個月時的緩解持續時間至少為 50% 或更高，我們相信這具有臨床意義，並且將是對當前護理標準的改進。

Importantly, in patient interviews conducted during the ENVISION trial, patients overwhelmingly prefer UGN-102 and said they would recommend it to other patients, highlighting the lack of disruption to daily life. And the UGN-102 was less invasive, less painful and less time consuming than the standard of care. If approved, UGN-102 will be the first and only nonsurgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.

重要的是，在 ENVISION 試驗期間進行的患者訪談中，絕大多數患者更喜歡 UGN-102，並表示他們會將其推薦給其他患者，強調不會對日常生活造成乾擾。而且 UGN-102 比標準護理侵入性更小、疼痛更小、耗時更少。如果獲得批准，UGN-102將成為第一個也是唯一一個治療以高復發率和多次手術為特徵的膀胱癌亞型的非手術主要療法。

Beyond our lead programs, we continue to advance our immuno-oncology candidate, UGN-301, into the clinic. UGN-301 is comprised of an anti-CTLA 4 antibody delivered using our proprietary RTGel technology. We are conducting a Phase 1 clinical study to evaluate the safety, tolerability, and establish a recommended Phase 2 dose for UGN-301 as monotherapy and in combination with other agents.

除了我們的主導項目之外，我們還繼續將我們的免疫腫瘤候選藥物 UGN-301 推向臨床。UGN-301 由使用我們專有的 RTGel 技術提供的抗 CTLA 4 抗體組成。我們正在進行一項 1 期臨床研究，以評估 UGN-301 的安全性、耐受性，並確定 UGN-301 作為單一療法和與其他藥物聯合治療的建議 2 期劑量。

Safety and tolerability data for the monotherapy arm are expected in mid-2024. We have also initiated combination therapy arms evaluating UGN-301 plus gemcitabine and UGN-301 plus UGN-201, our proprietary formulation of imiquimod, a TLR 7 agonist in high-grade NMIBC patients. We believe we have a unique approach in this area and look forward to providing updates on this trial as it moves forward.

單藥治療組的安全性和耐受性數據預計將於 2024 年中期公佈。我們也啟動了聯合治療組，評估 UGN-301 加吉西他濱和 UGN-301 加 UGN-201，我們的咪喹莫特專有製劑，一種用於高級別 NMIBC 患者的 TLR 7 激動劑。我們相信我們在這一領域擁有獨特的方法，並期待隨著試驗的進展提供有關該試驗的最新資訊。

Finally, as Liz mentioned at the beginning of the call, we are pushing ahead with next-generation formulations of our upper tract and bladder products for low-grade urothelial cancers. We look forward to commencing Phase 3 efforts for both drugs, UGN-103 for the bladder and UGN-104 for the upper tract soon, and we'll keep you posted as those clinical programs advance.

最後，正如 Liz 在電話會議開始時提到的那樣，我們正在推動低級別尿路上皮癌的上消化道和膀胱產品的下一代配方。我們期待很快開始這兩種藥物的 3 期工作，即用於膀胱的 UGN-103 和用於上泌尿道的 UGN-104，隨著這些臨床項目的進展，我們將及時通知您。

And with that, I will turn the call over to Jeff Bova to provide a commercial update. Jeff?

接下來，我會將電話轉給傑夫·博瓦 (Jeff Bova)，以提供商業更新。傑夫？

Thank you, Mark. JELMYTO sales, as Liz mentioned, were $23.5 million and $82.7 million for the fourth-quarter and full-year 2023, respectively. Demand remained strong in 2023. Despite achieving our targeted unit sales, the value of each unit was lower than anticipated, primarily due to gross-to-net erosion driven by higher-than-forecasted 340B rebate and estimated Medicare refunds for discarded drug offset by non-patient sales.

謝謝你，馬克。正如 Liz 所提到的，JELMYTO 2023 年第四季和全年的銷售額分別為 2,350 萬美元和 8,270 萬美元。2023 年需求依然強勁。儘管實現了我們的單位銷售目標，但每個單位的價值仍低於預期，這主要是由於高於預期的340B 回扣和估計的廢棄藥物醫療保險退款導致的總淨額侵蝕，被非患者銷售抵消。

We are providing guidance for 2024 for the first time today and are forecasting full-year JELMYTO net revenues to be in the range of $95 million to $102 million. While slightly lower than consensus, this reflects continued gross-to-net erosion despite anticipated continuing double-digit patient growth. Don will provide additional detail on our guidance in a few minutes.

我們今天首次提供 2024 年業績指引，並預測 JELMYTO 全年淨收入將在 9,500 萬美元至 1.02 億美元之間。雖然略低於共識，但這反映了儘管預計患者將持續兩位數成長，但總淨值持續下降。唐將在幾分鐘內提供有關我們指導的更多詳細資訊。

It is important to note that the CMS discarded drug provision will not impact UGN-102 as the bladder allows for installation without waste. Additionally, UGN-102 will be less sensitive to 340B since it will primarily be administered in the doctor's office. As mentioned in past calls, we've added regional operational managers, which helps every facet of the business, particularly operational rules intended to focus on opening new accounts and preparing them for JELMYTO use.

值得注意的是，CMS 廢棄藥物的供應不會影響 UGN-102，因為膠囊允許無浪費地安裝。此外，UGN-102 對 340B 的敏感度較低，因為它主要在醫生辦公室施用。正如在過去的電話會議中所提到的，我們增加了區域營運經理，這有助於業務的各個方面，特別是旨在專注於開設新帳戶並為 JELMYTO 使用做好準備的營運規則。

Our data show that territories with the most sites of care are the most successful and this role as instrumental in growing sites of care. There is a growing body of evidence from real-world evidence studies that continues to strengthen and reinforce JELMYTO's value proposition. We have data from over three years in the market that reinforce and support the product's efficacy and safety in the real-world setting.

我們的數據顯示，擁有最多護理場所的地區是最成功的，這一作用有助於增加護理場所。來自現實世界證據研究的越來越多的證據不斷強化和加強 JELMYTO 的價值主張。我們擁有三年多的市場數據，這些數據增強並支持了產品在現實環境中的功效和安全性。

I am pleased to report three aspects reviewing JELMYTO real-world evidence outcomes have been accepted at the upcoming AUA meeting, and our registry will provide additional insight into outcomes with JELMYTO use in the real-world setting.

我很高興地報告，審查 JELMYTO 現實世界證據結果的三個方面已在即將召開的 AUA 會議上被接受，我們的註冊表將提供有關 JELMYTO 在現實環境中使用的結果的更多見解。

For UGN-102, we are now executing our pre-commercialization plan in preparation for prospective launch in early 2025. This includes engaging with urologists and patient advocacy groups. There is approximately 95% overlap in the prescriber base with JELMYTO, which allows us to leverage our existing commercial organization.

對於 UGN-102，我們現在正在執行預商業化計劃，為 2025 年初的發射做準備。這包括與泌尿科醫生和患者倡導團體合作。處方者基礎與 JELMYTO 大約有 95% 的重疊，這使我們能夠利用現有的商業組織。

Our research tells us physicians are concerned with the high rate of recurrence in many of their patients who often experience limited intervals between TURBT. They're seeking strategies to prolong or extend the interval between recurrences as these patients don't get much of a break between the TURBT.

我們的研究告訴我們，醫生擔心許多患者的高復發率，這些患者的 TURBT 間隔時間通常很有限。他們正在尋求延長復發間隔的策略，因為這些患者在 TURBT 之間沒有太多的休息時間。

The literature shows that complete response rates for surgery at three months are in the range of 40% to 70%. Our understanding of bladder cancer is that the underlying pathology of this disease is not always visible to the surgeon. Normal appearing cells in the bladder may contain genetic abnormalities that will give rise to this recurrence.

文獻顯示，三個月時手術的完全緩解率為 40% 至 70%。我們對膀胱癌的理解是，外科醫生並不總是能看到這種疾病的潛在病理學。膀胱中正常的細胞可能含有遺傳異常，導致這種復發。

UGN-102 treats the disease in a way that permits us to not only treat the visible lesions, but also that background pathology. And we believe that's why we achieve better long-term disease control and longer disease-free intervals than the current standard of care in our ATLAS study.

UGN-102 治療疾病的方式使我們不僅可以治療可見病變，還可以治療背景病理。我們相信，這就是為什麼我們在 ATLAS 研究中比目前的護理標準實現了更好的長期疾病控制和更長的無病間隔。

We are also considering the economics of how bladder cancer is treated. There's a misconception that surgeons generate a lot of income from TURBT. The reality is that while overall costs of the surgery are quite high, surgeons are only paid a few hundred dollars per operation. Given the potential for better outcomes with UGN-102, we do not expect practice economics to be a barrier to adoption.

我們還在考慮膀胱癌治療的經濟學原理。人們有一種誤解，認為外科醫生從 TURBT 中獲得了大量收入。現實情況是，雖然手術的總體成本相當高，但外科醫生每次手術的報酬只有幾百美元。鑑於 UGN-102 具有取得更好結果的潛力，我們預期實踐經濟學不會成為採用的障礙。

Based on our market research, we believe the fastest adoption for UGN-102 would initially occur in three groups of patients. They are: patients who have had multiple recurrences, those who would be considered surgical failures; patients with early recurrence; and finally, patients who are ineligible or unwilling to undergo surgery.

根據我們的市場研究，我們相信 UGN-102 的最快採用最初將出現在三組患者中。他們是：多次復發的患者，將被視為手術失敗的患者；早期復發患者；最後，不適合或不願意接受手術的患者。

We are confident that as physicians gain experience in these early groups, UGN-102 will quickly expand to all recurrent patients, if approved. We look forward to providing additional insight into our plans as the year progresses.

我們相信，隨著醫生在這些早期群體中累積經驗，UGN-102 如果獲得批准，將迅速擴展到所有復發患者。隨著時間的推移，我們期待對我們的計劃提供更多見解。

I will now turn the call over to Don Kim to discuss our financials.

我現在將把電話轉給 Don Kim，討論我們的財務狀況。

Thank you, Jeff. Revenues for the fourth quarter of 2023 were $23.5 million compared to $18.1 million in the comparable period in 2022. Revenues for the full year ended December 31, 2023, was $82.7 million compared to $64.4 million in 2022.

謝謝你，傑夫。2023 年第四季的營收為 2,350 萬美元，而 2022 年同期營收為 1,810 萬美元。截至 2023 年 12 月 31 日的全年收入為 8,270 萬美元，而 2022 年為 6,440 萬美元。

Cost of revenues for the fourth-quarter and full-year 2023 for $2.3 million and $9.4 million, respectively, compared to $2.3 million and $7.7 million, respectively, for the fourth-quarter and full-year 2022. The overall increase of $1.7 million year over year was primarily due to the increased volume of JELMYTO sales.

2023 年第四季和全年的收入成本分別為 230 萬美元和 940 萬美元，而 2022 年第四季和全年的收入成本分別為 230 萬美元和 770 萬美元。整體年增 170 萬美元，主要是由於 JELMYTO 銷量的增加。

R&D expenses were $11.3 million and $45.6 million, respectively for the fourth-quarter and full-year 2023 compared with $14.5 million and $52.9 million, respectively, for the comparable period in 2022.

2023 年第四季和全年的研發費用分別為 1,130 萬美元和 4,560 萬美元，而 2022 年同期的研發費用分別為 1,450 萬美元和 5,290 萬美元。

The decrease in R&D expenses year over year is primarily attributable to lower research and development expenses due to the conclusion of ATLAS trial, lower costs related to Phase 3 ENVISION trial for UGN-102, and the ending of our collaboration with MD Anderson, partially offset by higher R&D expenses related to our Phase 1 study for UGN-301, cost incurred related to research into ingredients, scale-up and production for UGN-102, and clinical compensation expenses.

研發費用年減主要是由於 ATLAS 試驗結束導致研發費用減少、UGN-102 3 期 ENVISION 試驗相關成本降低以及我們與 MD 安德森合作的結束，部分抵消與UGN-301 一期研究相關的更高研發費用、與UGN-102 成分研究、放大和生產相關的成本以及臨床補償費用。

SG&A expenses were $24.6 million and $93.3 million, respectively for the fourth-quarter and full-year 2023 compared with $21.6 million and $82.8 million for the fourth-quarter and full-year 2022. The increase year over year was the result of the increase in brand marketing and general commercial expenses as well as increase in compensation expenses, third-party providers, recruiting fees, certain media and meeting expenses, and ongoing managed services. These were partially offset by lower commercial and back-office services and support expenses.

2023 年第四季和全年的 SG&A 費用分別為 2,460 萬美元和 9,330 萬美元，而 2022 年第四季和全年的 SG&A 費用分別為 2,160 萬美元和 8,280 萬美元。年比增長的原因是品牌行銷和一般商業費用的增加，以及薪酬費用、第三方提供者、招聘費用、某些媒體和會議費用以及持續管理服務的增加。這些費用被較低的商業和後台服務及支援費用所部分抵銷。

Interest expense was $3.6 million and $14.7 million, respectively, for the fourth-quarter and full-year 2023 compared with $3.2 million and $8.4 million, respectively, for the fourth-quarter and full-year 2022. Cost for the full year 2023 relate to interest expense on the Pharmakon loan for the four full quarters versus the prior year, given the funding of the first tranche and second tranche of the Pharmakon loan was in March 2022 and in December 2022, respectively.

2023 年第四季和全年的利息支出分別為 360 萬美元和 1,470 萬美元，而 2022 年第四季和全年的利息支出分別為 320 萬美元和 840 萬美元。鑑於 Pharmakon 貸款的第一筆和第二筆資金分別於 2022 年 3 月和 2022 年 12 月提供，2023 年全年成本與 Pharmakon 貸款四個完整季度與去年相比的利息支出相關。

In addition, the increase year over year was attributable to increase in interest rates related to the Pharmakon loan. Net loss was $26 million or $0.72 per share and $102.2 million or $3.55 per share for the fourth-quarter and full-year 2023. This compares with net losses of $28.9 million or $1.25 per share and $109.8 million or $4.81 per share for the fourth-quarter and full-year 2022.

此外，年成長是由於與Pharmakon貸款相關的利率上升。2023 年第四季和全年淨虧損為 2,600 萬美元或每股 0.72 美元，淨虧損為 1.022 億美元或每股 3.55 美元。相比之下，2022 年第四季和全年的淨虧損為 2,890 萬美元或每股 1.25 美元，淨虧損為 1.098 億美元或每股 4.81 美元。

UroGen had $141.5 million in cash and cash equivalents and marketable securities at December 31, 2023. Based on our latest financial forecast, we believe our current cash position and resources and projected revenue will support our commercial organization through the potential launch of UGN-102 in early 2025.

截至 2023 年 12 月 31 日，UroGen 擁有 1.415 億美元的現金和現金等價物以及有價證券。根據我們最新的財務預測，我們相信我們目前的現金狀況和資源以及預計收入將支持我們的商業組織在 2025 年初推出 UGN-102。

Switching now to 2024 full-year guidance. We anticipate full-year 2024 JELMYTO net revenues to be in the range of $95 million to $100 million. Full-year operating expense is expected to be in the range of $175 million to $185 million, including non-cash share-based compensation expense of $6 million to 11 million, subject to market conditions.

現在切換至 2024 年全年指導。我們預計 JELMYTO 2024 年全年淨收入將在 9,500 萬美元至 1 億美元之間。全年營運費用預計在 1.75 億美元至 1.85 億美元之間，其中包括 600 萬美元至 1,100 萬美元的非現金股份補償費用，具體​​取決於市場狀況。

We have continued to prioritize all expenses in support of our efforts to prioritize cash preservation. Financing expense related to the prepaid forward obligation to RTW Investments is expected to be in the range of $21 million to $26 million, of which approximately $12.4 million to $13.3 million will be in cash.

我們繼續優先考慮所有支出，以支持我們優先考慮現金保存的努力。與 RTW Investments 預付遠期債務相關的融資費用預計在 2,100 萬美元至 2,600 萬美元之間，其中約 1,240 萬美元至 1,330 萬美元將為現金。

In addition to RTW financing expense, interest only payments on the $100 million term loan facility with the funds managed by Pharmakon Advisors, will continue to be made quarterly and accrue at a rate of adjusted term SOFR plus 7.25% in 2024.

除了 RTW 融資費用外，由 Pharmakon Advisors 管理的資金為 1 億美元定期貸款安排支付的僅利息將繼續按季度支付，並按調整後的定期 SOFR 利率在 2024 年加 7.25% 計算。

For further details on our financials, please refer to our annual report on Form 10-K with the SEC.

有關我們財務狀況的更多詳細信息，請參閱我們向 SEC 提交的 10-K 表格年度報告。

We are now ready to open the call for questions. Operator?

我們現在準備開始提問。操作員？

(Operator Instructions)

（操作員說明）

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特，TD·考恩。

Hi, good morning. So I was hoping you could tell us more about what you envision for how the early launch of UGN-102 can look like. And I understand there's significant overlap in practice across the two products with JELMYTO.

早安.所以我希望您能告訴我們更多關於 UGN-102 早期發射的設想。據我所知，JELMYTO 的兩種產品在實踐中存在顯著的重疊。

So I was hoping to better understand how you're thinking about commercial synergy and how you expect that to play out in the coming years as UGN-102 launches.

因此，我希望更好地了解您如何看待商業協同效應，以及您期望在未來幾年隨著 UGN-102 的推出，這種協同效應將如何發揮作用。

Hi, Tara. Thanks for the message. And apologize for my voice. I'm kind of overcoming a bad head cold right now. So I'm going to turn it over to Jeff. But just say to your point, lots of synergy here, but we also want to ensure early significant uptake. And so because of that, we are adding resources. But Jeff, can you put more color around exactly what that's going to look like?

嗨，塔拉。感謝你的資訊。並為我的聲音道歉。我現在正在克服重感冒。所以我要把它交給傑夫。但只是說一下你的觀點，這裡有很多協同作用，但我們也希望確保儘早顯著採用。因此，我們正在增加資源。但是傑夫，你能為它的外觀添加更多顏色嗎？

And I also want to let everybody know that we have Silvio Pacheco, our Vice President of Market Access, join the call as well. In case if anyone wanted more details around the wastage provision or the gross to net. But Jeff, why don't you answer the question?

我還想讓大家知道，我們的市場准入副總裁西爾維奧·帕切科（Silvio Pacheco）也加入了電話會議。如果有人想了解更多有關浪費規定或淨值總額的詳細資訊。但是傑夫，為什麼不回答這個問題呢？

Sure. Hi, Tara. So I have said in the past, we look to expand one to two regions. I feel comfortable now confirming we will expand a region and roughly go from 45 to 60 TBMs. Two main drivers there: there's obviously the 45 territories, you have some significant geography. So we would increase the efficiency there with those TBMs.

當然。嗨，塔拉。所以我過去說過，我們希望擴大一到兩個地區。我現在很放心地確認我們將擴大一個區域，並將 TBM 數量大致從 45 台增加到 60 台。有兩個主要驅動因素：顯然有 45 個地區，並且有一些重要的地理因素。因此，我們將利用這些隧道掘進機來提高效率。

And then the other is there are a lot of more physicians that really do specialize in bladder cancer. As opposed to upper tract, not a lot of urologists really do a significant number of upper tract, quite contrary with bladder. There are more urologists that specialize in bladder. And we want to make sure that we increase and have a significant reach and frequency on those key targets.

另一個是有更多的醫生真正專注於膀胱癌。與上泌尿道相反，沒有多少泌尿科醫生真正做大量的上泌尿路，與膀胱相反。有更多專門研究膀胱的泌尿科醫生。我們希望確保我們在這些關鍵目標上增加並具有顯著的影響力和頻率。

We've talked about the operational difference between UGN-102 and JELMYTO. We're obviously looking at how to deliver the product. I talk to you the fact that we may go out with just a mixed product which will allow for additional convenience. And then the obviously the buy-and-build portion of this. Silvio is on the call, but we'll prepare for everything ready to get a permanent J-code soon thereafter launch.

我們已經討論了 UGN-102 和 JELMYTO 之間的操作差異。顯然我們正在研究如何交付產品。我告訴你的事實是，我們可能只推出混合產品，這將帶來更多便利。然後顯然是購買和建造部分。Silvio 正在接聽電話，但我們將做好一切準備，以便在發布後不久獲得永久 J 代碼。

Those three areas that I talked about earlier will be the areas we will certainly focus position and message on, with the goal of obviously and growing into just really any patient that recurs, it would be a candidate for UGN-102.

我之前談到的這三個領域將是我們肯定會重點關注的領域和訊息，目標顯然是讓任何復發的患者都成為 UGN-102 的候選者。

Leland Gershell, Oppenheimer.

利蘭·格謝爾，奧本海默。

Hi, good morning. Thanks for taking my questions. Two for me. First for -- I guess for Jeff, just wanted to ask a bit more on the 340B related discounting. Is that something which we would expect to see perhaps more of as we get through 2024 and beyond for JELMYTO? Or is that kind of a one-time dynamic that we do not have as much concern about in terms of its impact on what maybe your 2024 guidance? And if you could also share to what extent JELMYTO business exposed to 340B? And then I have a question for Mark. Thank you.

早安.感謝您回答我的問題。給我兩個。首先，我想是傑夫，只是想多問一些 340B 相關折扣的問題。在 2024 年及以後的時間裡，我們是否會期望在 JELMYTO 上看到更多這樣的情況？或者說，這是一種一次性的動態，我們不太關心它對 2024 年指導方針的影響？您是否也可以分享一下JELMYTO業務在多大程度上暴露於340B？然後我有一個問題要問馬克。謝謝。

Thanks, Leland. Why don't we ask Silvio to have comment on the 340B and what we saw last year and what we think will continue.

謝謝，利蘭。我們為什麼不請 Silvio 對 340B 以及我們去年看到的情況以及我們認為將會繼續發生的情況發表評論。

Leland, thanks for the question. So what I would say is similar to other companies, the impact of 340B as a macro event. And as we all know that the program, the 340B program continues to expand in the marketplace and continues to be a challenge for manufacturers. It is -- at this point, we closely monitor what potentially the impact may be, and we will certainly continue to see how we forecast for that in the future.

利蘭，謝謝你的提問。所以我想說的是和其他公司類似，340B作為一個宏觀事件的影響。眾所周知，340B 方案在市場中不斷擴大，並且仍然對製造商構成挑戰。目前，我們正在密切關注可能產生的潛在影響，並且我們肯定會繼續關注未來的預測。

What I would like to say, though, is as we start thinking about UGN-102, as Jeff mentioned, we anticipate that the adoption of UGN-102 will be primarily in the community space of private practice and therefore will not have as much of an impact or be impacted as much by the 340B program.

不過，我想說的是，正如傑夫所提到的，當我們開始考慮 UGN-102 時，我們預計 UGN-102 的採用將主要在私人診所的社區空間中進行，因此不會有太多的影響或受到340B 計劃的影響。

And Silvio, just to answer this question, I think we feel like we don't expect it to continue to grow, Leland, significantly versus where we are. I just want to make sure that sort of -- you know, obviously, there may be some risks, but we projected for the year a little bit of erosion, but very minor compared to the past.

Silvio，只是為了回答這個問題，我認為我們認為我們不希望它繼續增長，利蘭，與我們現在的情況相比，顯著增長。我只是想確保這種 - 你知道，顯然，可能存在一些風險，但我們預計今年會出現一點侵蝕，但與過去相比非常小。

So as Silvio said, it's -- every company is probably -- in my view, it's the biggest challenge we have as an industry, as 340B discounts. But I think we're in a stable position, a more stable position now over the last couple of years.

正如 Silvio 所說，在我看來，每家公司都可能是，340B 折扣是我們作為一個行業面臨的最大挑戰。但我認為我們處於一個穩定的位置，在過去幾年中更加穩定。

Thanks, Liz. So that's all very helpful. And then, Mark, just wanted to ask, obviously, NMIBC, highly recurrent disease. And given the level of recurrence, you know, could be a pretty strong use of UGN-102 as a friendlier option than TURBT. But wanted to ask about risk of progression from low grade to high grade and even to MIBC. How does that kind of play into urologists' sort of interest and productivity, I guess in terms of treating patients who have recurrent disease? Is there sort of a time factor as patients recur that there is an increased chance that they will progress and therefore those patients should come in sooner for procedures? Maybe, Mark, if you could kind of share us from a medical perspective what the risk of progression beyond the grade is. Thank you.

謝謝，莉茲。所以這一切都非常有幫助。然後，馬克，顯然只是想問，NMIBC，高度復發的疾病。考慮到復發的程度，您知道，UGN-102 可能是比 TURBT 更友善的選擇。但想詢問從低級進展到高級甚至 MIBC 的風險。我想，在治療復發性疾病患者方面，這如何影響泌尿科醫師的興趣和生產力？當患者復發時，是否存在某種時間因素，導致他們病情進展的機會增加，因此這些患者應該儘早接受手術？也許，馬克，如果你能從醫學角度告訴我們，超出等級的風險是什麼。謝謝。

Leland, thanks, and sure. It's an interesting clinical question. What we know about this population of intermediate risk low-grade station is that the contracts that are risk progression operator at a higher rate bases or even muscle-invasive disease is exceedingly low.

利蘭，謝謝，當然。這是一個有趣的臨床問題。我們對這些中風險低級別人群的了解是，以較高比率基礎甚至肌肉侵襲性疾病進行風險進展操作的合約非常低。

In our experience, progression of muscle invasion is zero. So from our own clinical experience in UroGen. (technical difficulty) population, which is carefully followed in any event.

根據我們的經驗，肌肉侵襲的進展為零。根據我們自己在 UroGen 的臨床經驗。 （技術難度）人口，無論如何都要仔細遵循。

So the likelihood of progression muscle invasion in the near-term scenario would be very unlikely. (technical difficulty)

因此，在近期情況下，肌肉侵襲進展的可能性非常小。（技術難度）

As you heard Liz and others say on many occasions, our experience and that of others is that this is a chronically relapsing illness, (technical difficulty) surgical resection, every time they have a recurrence.

正如你在許多場合聽到Liz和其他人說的那樣，我們和其他人的經驗是，這是一種慢性複發性疾病，（技術難度）手術切除，每次都復發。

Okay, thanks. I think, I got most of that. A little broken up on the connection, but thank you for taking the question.

好的謝謝。我想，我已經得到大部分了。連接有點中斷，但感謝您提出問題。

Paul Choi, Goldman Sachs.

保羅‧崔，高盛。

Hi, thanks and good morning. Thank you for taking our questions. My first question is for Mark. I think there seems to be some persistent confusion in the market just with regard to follow-up period for ENVISION here. And could you maybe just again clarify for us what the total follow-up period will be? It's three months for the installation period followed by 12 months, if my understanding is correct, if you could just confirm that for us.

你好，謝謝，早安。感謝您接受我們的提問。我的第一個問題是問馬克的。我認為市場對於遠景的後續時期似乎存在一些持續的困惑。您能否再次向我們澄清一下總的追蹤期是多少？安裝期是三個月，然後是12個月，如果我的理解正確的話，如果你能為我們確認一下的話。

Paul, thank you. I hope you can hear me. You're absolutely correct. So when we say 12 months of follow-up, we mean 12 months after the initial evaluations (technical difficulty)

保羅，謝謝你。我希望你能聽到我的聲音。你是完全正確的。因此，當我們說 12 個月的追蹤時，我們指的是初始評估後 12 個月（技術難度）

So it would be 15 months from the beginning of the study, but 12 months from the primary disease evaluation. So you are correct. It's 12 months after that initial three month (technical difficulty). So 15 months into the trial, 12 months following CR.

因此，距離研究開始還有 15 個月，但距離原發病評估還有 12 個月。所以你是對的。最初三個月過去了 12 個月（技術難度）。試驗進行了 15 個月，CR 後 12 個月。

Great. Perfect. Thanks and thanks for clarifying the 15 months of total time. And then my second question is just for both maybe Liz and Don, just with respect to the guidance and cash burn. If we take midpoint of your revenue guidance and the midpoint of your OpEx guidance and we strip out the non-cash items, including stock comp as well as the RTW financing expense, we get to a range of roughly $40 million to $45 million in incremental cash burn versus 2023.

偉大的。完美的。感謝並感謝您澄清 15 個月的總時間。然後我的第二個問題可能是針對莉茲和唐的，只是關於指導和現金消耗。如果我們採用您的收入指導和營運支出指導的中點，並剔除非現金項目，包括股票補償以及 RTW 融資費用，我們將獲得大約 4000 萬至 4500 萬美元的增量範圍與2023 年相比的現金消耗情況。

And I was just wondering if you could clarify how much of that is related to the build out of your sales force that Jeff referenced earlier versus incremental R&D spend for UGN-103 and UGN-104 and just the timing of when that cash burn would potentially accelerate. Are we correct to assume that it will be primarily back end weighted towards the end of 2024? Thanks so much.

我只是想知道您是否能澄清其中有多少與傑夫之前提到的銷售隊伍建設與 UGN-103 和 UGN-104 的增量研發支出有關，以及現金消耗可能發生的時間加速。我們假設到 2024 年底它將主要是後端加權，這是否正確？非常感謝。

So I'll let Don give you details. But yes, towards the -- you are right, it will be more in the back end. But Don, do you want to give more color around that?

所以我會讓唐給你詳細資料。但是，是的，你是對的，它會更多地發生在後端。但唐，你想為此賦予更多色彩嗎？

Yes, Liz. So thank you, Paul. So basically in this $40 million increase in OpEx, you are correct. And big portion like 25%, 30% of the $40 million increase is actually one or two commercial, the product build up. Because before we get the FDA approval, we cannot use this as cost. So we just use it as expense for inventory buildup.

是的，莉茲。所以謝謝你，保羅。所以基本上在這 4000 萬美元的營運支出成長中，你是對的。4000 萬美元成長中的 25%、30% 等很大一部分實際上是一兩個商業產品的累積。因為在我們獲得FDA批准之前，我們不能用這個作為成本。所以我們只是將其用作庫存累積的費用。

And another question on 50% of this incremental OpEx is obviously the sales force buildup and brand marketing. So as you just mentioned that, yes, it's more of a back end of the year, but it will be incremental costs.

50% 增量營運支出的另一個問題顯然是銷售隊伍建立和品牌行銷。正如您剛才提到的，是的，這更多是在今年年底，但這將是增量成本。

And there are just minor incremental and R&D because of the 103 and 104 trials starting this year.

由於今年開始的 103 和 104 項試驗，只有少量的增量和研發。

Matthew Kaplan, Ladenburg Thalmann.

馬修卡普蘭，拉登堡塔爾曼。

Good morning, guys. Thanks for taking the questions. I guess just staying UGN-102 initially. What's your expected chance for the FDA toward a priority review once the final is complete in September?

早上好傢伙。感謝您提出問題。我想一開始就留在UGN-102。一旦 9 月的決賽結束，您預計 FDA 獲得優先審查的機會有多大？

Look, you never know, Matt, so we can't guarantee it. But I think there's a lot of things going in our favor. One, we had a priority review for JELMYTO. Two, assuming the data is consistent, when we see the duration data, the data right now is very compelling. And I think that the FDA understands the unmet need out there and the need to get these treatments out there. So we believe we have a high probability of a priority review, and that's our expectation.

聽著，你永遠不知道，馬特，所以我們不能保證。但我認為有很多事情對我們有利。第一，我們對 JELMYTO 進行了優先審查。第二，假設數據是一致的，當我們看到持續時間數據時，現在的數據非常引人注目。我認為 FDA 理解尚未滿足的需求以及推出這些治療方法的必要性。所以我們相信我們有很高的機率獲得優先審查，這也是我們的預期。

So again, you can't say for sure, because we won't know until we file and ask for priority review, but we did get the rolling submission that we asked for. We have started that, as you know. So I think that we feel like we're in a good position to do that.

再說一次，你不能肯定地說，因為在我們提交並要求優先審查之前我們不會知道，但我們確實得到了我們要求的滾動提交。如您所知，我們已經開始這樣做了。所以我認為我們感覺我們有能力做到這一點。

Sure. Makes sense. And then in terms of after approval, what's your expected ramp of payer coverage for 102 and how should we think about that?

當然。說得通。然後，就批准後而言，您對 102 的付款人承保範圍的預期增長是多少？我們應該如何考慮？

Silvio, since you've joined us today, why don't you talk about the payer from a 102 perspective.

Silvio，既然你今天加入我們，為什麼不從102的角度來談談付款人呢？

Sure. Matt, thanks for the question. From a payer coverage perspective, I think there's a couple of elements to consider. One is the inclusion of 102 in the treatment guidelines with the National Comprehensive Cancer Network and also the application of the J-code. So the application for a J-code happens on a quarterly basis and it is dependent on the FDA approval.

當然。馬特，謝謝你的提問。從付款人承保範圍的角度來看，我認為有幾個因素需要考慮。一是將102納入國家綜合癌症網絡的治療指南並應用J代碼。因此，J 代碼的申請每季度進行一次，並且取決於 FDA 的批准。

So we will work expeditiously to get to the J-code up and running, and we will start engaging payers in the next few months here, providing them with some pre-approval information so. They can become aware of UGN-102 and the clinicals value proposition of UGN-102.

因此，我們將迅速啟動並運行 J 代碼，我們將在接下來的幾個月內開始與付款人互動，為他們提供一些預先批准的資訊。他們可以了解 UGN-102 和 UGN-102 的臨床價值主張。

Silvio, can you just comment, wait -- I mean our expectation, we have over 99% coverage on JELMYTO. We don't expect it to be different for UGN-102. We expect significant coverage out of the gates.

Silvio，您能發表評論嗎？等等——我的意思是我們的期望，我們對 JELMYTO 的覆蓋率超過 99%。我們預計 UGN-102 不會有什麼不同。我們預計將有大量報導。

As you know, about 70% of the population is Medicare. And that gets covered because if you get an FDA approval, then Medicare covers it. So we don't really have an issue there. And even with commercial initially, we won't have a problem and we expect it to be pretty close to where we are with JELMYTO, which I would say over 99% coverage.

如您所知，大約 70% 的人口有醫療保險。這會得到承保，因為如果您獲得 FDA 批准，那麼 Medicare 就會承保。所以我們確實沒有問題。即使最初是商業廣告，我們也不會有問題，我們預計它會非常接近 JELMYTO 的情況，我想說覆蓋率超過 99%。

And then just with UGN-103 and -104, you stated that you plan to start Phase 3 development of both, but that it would be smaller and more focused studies. Can you give us a little bit more detail in terms of what the regulatory path looks like for both of those? Is it just one study needed for each of them or how will it work, do you think?

然後就 UGN-103 和 -104 而言，您表示計劃開始兩者的第三階段開發，但這將是規模更小、更有針對性的研究。您能否為我們提供更多有關這兩者的監管路徑的詳細資訊？您認為每個人都只需要一項研究嗎？或者它將如何運作？

Yeah. When we spoke to the FDA about it in a day, they felt like they were different enough that we needed a clinical study. And as we've said in the past, we actually think that's good news. Because if we have to do it, so will others, right? And that's part of our strategy around any other company trying to come in into our space.

是的。當我們在一天內與 FDA 討論這個問題時，他們覺得它們足夠不同，以至於我們需要進行臨床研究。正如我們過去所說，我們實際上認為這是個好消息。因為如果我們必須這樣做，其他人也會這樣做，對吧？這是我們針對任何其他試圖進入我們領域的公司的策略的一部分。

So we feel really good about that. But what we have discussed with the FDA and we'll continue to align with them, is that we need to show efficacy -- safety, efficacy, and durability, but they want to see results consistent, but we don't have to have the same timeline.

所以我們對此感覺非常好。但我們與 FDA 討論過並將繼續與他們保持一致的是，我們需要展示功效——安全性、有效性和持久性，但他們希望看到結果一致，但我們不必相同的時間線。

So the 102 study will be probably around 85 patients. So if you think about ENVISION at 220 patients where we ended up at 240 patients, we only have to do an 85-patient study and something smaller than that for UGN-104 for the next-generation JELMYTO formulation. So maybe in the 50- to 60-patient perspective,

因此，102 項研究可能涉及 85 名患者左右。因此，如果你考慮ENVISION 的受試者為220 名患者，而我們最終的受試者為240 名患者，那麼我們只需要進行一項85 名患者的研究，並且在下一代JELMYTO 配方中進行比UGN -104 小的研究。所以也許從 50 到 60 名患者的角度來看，

We're prioritizing new UGN-102 for obvious reasons from a start perspective and then the follow-up is well. So as long as the results are consistent, then the FDA is open to us filing on a less data, but just showing consistency. And so that's kind of where we are. So our expectation at this point is that we would have approval for both of those in the 2027 time period.

從一開始我們就優先考慮新的 UGN-102，原因很明顯，然後後續工作就很好。因此，只要結果一致，FDA 就會允許我們提交較少的數據，但只是顯示一致性。這就是我們現在的處境。因此，我們目前的預期是，我們將在 2027 年期間批准這兩項計劃。

So we feel really good about kind of where we are in our ability to get those approved again, get the J-code for both of them, and do an appropriate switch to the new formulation before taking the old formulations off the market.

因此，我們對我們能夠再次獲得這些批准、獲得它們的 J 代碼以及在將舊配方撤出市場之前適當切換到新配方的能力感到非常滿意。

That concludes today's question-and-answer session. I'd like to turn the call back to Liz Barrett for closing remarks.

今天的問答環節到此結束。我想將電話轉回給莉茲·巴雷特（Liz Barrett）做結束語。

Yeah. Thanks, and thanks, everybody, for joining. And I think everybody understands that this is a defining year for us at UroGen. We're excited about the prospects about preparing for UGN-102 while continuing to increase adoption of JELMYTO. And we're seeing a nice events and nice data coming out of our registry and out of some investigator-initiated areas. So thanks. We'll keep you guys posted as things go along and really always appreciate your interest in our company. Thank you.

是的。謝謝，謝謝大家的加入。我想每個人都明白，今年對我們 UroGen 來說是決定性的一年。我們對準備 UGN-102 同時繼續增加 JELMYTO 的採用的前景感到興奮。我們看到來自我們的註冊表和一些調查員發起的區域的良好事件和數據。那謝謝啦。隨著事情的進展，我們會隨時向大家通報情況，並且非常感謝您對我們公司的興趣。謝謝。

Operator, you can disconnect now.

接線員，您現在可以斷開連接了。