Legend Biotech Corp (LEGN) 2025 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to the Legend Biotech first-quarter 2025 earnings call. (Operator Instructions)

您好，感謝您的支持。歡迎參加傳奇生物2025年第一季財報電話會議。（操作員指示）

Please be advised that today's conference is being recorded. I'd like to hand the conference over to your first speaker today, Caroline Paul, Associate Director of Investor Relations. Please go ahead.

請注意，今天的會議正在錄音。我想將會議交給今天的第一位發言人，投資者關係副總監 Caroline Paul。請繼續。

Good morning. This is Caroline Paul, Associate Director of Investor Relations at Legend Biotech. Thank you for joining our conference call today to review our first quarter of 2025 performance. Prior to this call, we issued a press release announcing our financial results for the quarter. You can find the press release on our IR website at legendbiotech.com.

早安.我是傳奇生物投資者關係副總監 Caroline Paul。感謝您今天參加我們的電話會議，回顧我們 2025 年第一季的業績。在本次電話會議之前，我們發布了一份新聞稿，宣布了本季的財務表現。您可以在我們的 IR 網站 legendbiotech.com 上找到該新聞稿。

Joining me on today's call are Ying Huang, the company's Chief Executive Officer; Alan Bash, the company's President of CARVYKTI; and Jessie Yeung, the company's Interim Chief Financial Officer. Following the prepared remarks, we will open up the call for Q&A. We have our President of R&D, Guowei Fang; and Chief Medical Officer, Mythili Koneru, joining the Q&A session.

參加今天電話會議的還有公司執行長黃英； CARVYKTI 公司總裁 Alan Bash；以及該公司臨時財務長 Jessie Yeung。準備好的發言結束後，我們將開始問答環節。我們的研發總裁是方國偉；和首席醫療官 Mythili Koneru 參加問答環節。

During today's call, we will be making forward-looking statements which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied here within. These forward-looking statements are discussed in greater detail in our SEC filings, which we encourage you to read and can be found under the investor section of our company website.

在今天的電話會議中，我們將做出前瞻性陳述，這些陳述受風險和不確定性的影響，可能導致我們的實際結果與此處明示或暗示的結果有重大差異。這些前瞻性陳述在我們的美國證券交易委員會 (SEC) 文件中有更詳細的討論，我們鼓勵您閱讀，您可以在我們公司網站的投資者部分找到。

In addition, adjusted net loss is a non-IFRS metric. This non-IFRS financial measure is in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with IFRS. There are a number of limitations related to the use of these non-IFRS financial measures versus their closest IFRS equivalents. However, we believe that providing information concerning adjusted net loss and adjusted net loss per share enhances an investor's understanding of our financial performance.

此外，調整後的淨虧損是非國際財務報告準則指標。此非國際財務報告準則財務指標是根據國際財務報告準則所編製的財務績效指標的補充，並不取代或優於該指標。與最接近的 IFRS 財務指標相比，使用這些非 IFRS 財務指標有許多限制。但是，我們相信提供有關調整後淨虧損和調整後每股淨虧損的資訊可以增強投資者對我們財務業績的了解。

We use adjusted net loss as a performance metric that guides management in its operation of and planning for the future of the business. We believe that adjusted net loss provides a useful measure of our operating performance from period to period by excluding certain items that we believe are not representative of our core business. Our press release includes IFRS to non-IFRS reconciliations for these measures. With that, I will now turn the call over to Ying.

我們使用調整後的淨虧損作​​為績效指標，指導管理階層的營運和未來業務規劃。我們認為，透過排除我們認為不代表我們核心業務的某些項目，調整後的淨虧損可以有效衡量我們各個時期的經營績效。我們的新聞稿包括這些措施的國際財務報告準則與非國際財務報告準則的對帳。說完這些，我現在將電話轉給 Ying。

Hello, everyone. Thank you for joining us today. During the first quarter, we continued executing on our strategic priorities by increasing the number of global ATCs and patients treated with CARVYKTI in partnership with J&J, delivering operational efficiency and making continued investment. We continue to anticipate achieving operational break even for coveted by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses.

大家好。感謝您今天加入我們。在第一季度，我們繼續執行我們的策略重點，與強生公司合作增加全球 ATC 和接受 CARVYKTI 治療的患者數量，提高營運效率並持續投資。我們仍然預計，到 2025 年底，公司將實現收支平衡，到 2026 年，公司將實現全公司盈利（不包括未實現的外匯收益或損失）。

Regarding CARVYKTI performance during the first quarter, net trade sales were approximately $369 million, which is a 135% increase year over year. We have now treated over 6,000 patients with CARVYKTI, and our CARVYKTI launch remains the strongest CAR-T launch to date. In the US, more than half of our utilization is now in the earlier line setting.

關於 CARVYKTI 第一季的業績，淨貿易銷售額約為 3.69 億美元，年增 135%。目前，我們已經使用 CARVYKTI 治療了超過 6,000 名患者，而我們的 CARVYKTI 上市仍然是迄今為止最強勁的 CAR-T 上市。在美國，我們現在一半以上的利用率都處於早期線路設定中。

In a recent 50 respondents survey, after presenting (inaudible) 4 data to 86% of physicians from the community setting, preference for CARVYKTI in early line multiple myeloma rose from 34% to 55%. On this note, we're very pleased that overall survival was added to CARVYKTI's EMA label based on the CHMP positive opinion of data from CARTITUDE-4. We're also pleased that Australia's regulator has now approved CARVYKTI in the second line plus setting. We're looking forward to bringing CARVYKTIto more patients outside the US who might benefit from its differentiated efficacy.

在最近對 50 名受訪者進行的調查中，在向 86% 的社區醫生展示 (聽不清楚) 4 個數據後，對早期多發性骨髓瘤使用 CARVYKTI 的偏好度從 34% 上升到 55%。就此而言，我們非常高興，基於 CHMP 對 CARTITUDE-4 數據的正面評價，總存活期被添加到 CARVYKTI 的 EMA 標籤中。我們也很高興澳洲監管機構現已批准將 CARVYKTI 用於二線加治療。我們期待將 CARVYKTI 帶給美國以外的更多患者，讓他們能夠受益於其差異化的療效。

CARVYKTI's profile continues to be demonstrated through extensive data, and we continue to facilitate best practice sharing as we treat more and more patients and generate additional safety data. For example, we've already incorporated additional safety measures in our ongoing CARVYKTI programs, and new data is constantly being generated about cCARVYKTI's benefit versus risk profile. As a result of the posters presented attend the meeting and given that patients are already doing routine blood work, the majority of centers administered CARVYKTI have implemented monitoring for absolute lymphocyte count, followed by dexamethasone intervention as needed. We'll continue highlighting new safety data to the oncology community as it is reported. On the clinical front for CARVYKTI, we continue to expect to complete enrollment for (inaudible) 6 this year. We believe the (inaudible) 5 and 6 trials are key to moving CARVYKTI into the frontline setting.

CARVYKTI 的概況繼續透過大量數據得到證明，並且隨著我們治療越來越多的患者並產生額外的安全數據，我們將繼續促進最佳實踐的共享。例如，我們已經在正在進行的 CARVYKTI 計劃中加入了額外的安全措施，並且不斷產生有關 cCARVYKTI 的益處與風險狀況的新數據。由於會議上展示的海報，並且考慮到患者已經在進行常規血液檢查，大多數使用 CARVYKTI 的中心都實施了絕對淋巴細胞計數監測，然後根據需要進行地塞米松幹預。我們將繼續向腫瘤學界重點介紹新的安全數據。在 CARVYKTI 的臨床方面，我們預計今年將繼續完成 (聽不清楚) 6 人的招募。我們相信（聽不清楚）5 和 6 項試驗是將 CARVYKTI 推向前線環境的關鍵。

Looking at long-term growth for Legend, in addition to moving CARVYKTI into the front line, we remain focused on building out our pipeline programs. As part of our mission to serve more patients around the world through innovative cell therapies, we're investing in research and development where we can bring to bear our industry leading expertise to drive the advancement of innovative new assets. This includes In Vivo Party Delivery, which we believe represents an important opportunity to strengthen our cell therapy leadership.

著眼於 Legend 的長期發展，除了將 CARVYKTI 轉移到前線之外，我們仍將專注於建立我們的管道計劃。作為我們透過創新細胞療法服務全球更多患者的使命的一部分，我們正在投資研發，利用我們行業領先的專業知識來推動創新新資產的進步。其中包括體內派對交付，我們認為這是加強我們細胞治療領導地位的重要機會。

We are excited about the new research facility currently being built in Philadelphia, where In Vivo Delivery will be one of its key focuses, positioning as well to pursue this area of innovation with the right infrastructure and resources. We believe this next generation approach to off the shelf therapy holds a lot of promise for incurable diseases by reprogramming immune cells directly in the body through direct infusion. The need for Ex Vivo cell engineering and manufacturing is eliminated. No lympho depletion aphesis are necessary for In Vivo Delivery, enabling even more scalable manufacturing. We're excited to be embarking on this next frontier of cell therapy innovation, and we look forward to providing additional updates as we make progress on this front.

我們對目前正在費城建設的新研究設施感到非常興奮，體內遞送將是其重點之一，我們也將利用適當的基礎設施和資源來推進這一創新領域。我們相信，這種透過直接輸注在體內重新編程免疫細胞的下一代現成治療方法對治療無法治癒的疾病大有希望。不再需要體外細胞工程和製造。體內遞送不需要進行淋巴球耗竭術，以實現更具可擴展性的製造。我們很高興能夠踏上細胞治療創新的下一個前沿，並期待在這一方面取得進展時提供更多更新。

Turning to our upcoming anticipated company milestones, we anticipate growth to be driven by capacity expansion in Belgium and in New Jersey, which Alan will detail in just a moment. In addition to increasing our manufacturing capacity, we continue to work towards the overall survival benefit being included in the US label now that it's already in the European label.

談到我們即將實現的公司里程碑，我們預計成長將受到比利時和新澤西產能擴張的推動，艾倫稍後將詳細介紹。除了提高我們的製造能力之外，我們還將繼續努力將整體生存效益納入美國標籤中，因為它已經包含在歐洲標籤中。

To sum up, regardless of the current macroeconomic uncertainties, Legend endures as the largest stand-alone cell therapy company with over 6,000 patients treated by CARVYKTI as we force the past to cure. With a cash position of approximately $1 billion, we are investing in our core differentiators and remain focused on delivering operational efficiency in order to ensure durable, long-term growth. With that, I'll pass it over to Alan to provide an update on CARVYKTI.

總而言之，無論當前宏觀經濟的不確定性如何，傳奇公司仍然是最大的獨立細胞治療公司，超過 6,000 名患者接受了 CARVYKTI 治療，我們正努力治癒過去。我們擁有約 10 億美元的現金，正在投資於我們的核心差異化因素，並繼續專注於提高營運效率，以確保持久的長期成長。說完這些，我將交給艾倫 (Alan) 來提供有關 CARVYKTI 的最新資訊。

Thanks, Ying. Moving on to CARVYKTI's performance, as Ying mentioned, net trade sales of CARVYKTI were approximately $369 million which is a 135% increase year over year and a 10% increase from the fourth quarter. Our global growth was driven by continued share gains and capacity expansion.

謝謝，英。談到 CARVYKTI 的業績，正如 Ying 所提到的，CARVYKTI 的淨貿易銷售額約為 3.69 億美元，同比增長 135%，環比第四季度增長 10%。我們的全球成長得益於持續的市場份額成長和產能擴張。

US net trade sales of $318 million grew 127% year over year and 5% quarter over quarter. In the US, we continue to certify more hospitals as authorized treatment centers, and the total number of US hospitals that are certified to treat with the CARVYKTI is now 114. We remain pleased with the progress we have made in the outpatient setting and continue to anticipate that a majority of our volume will be coming from outpatient use by the end of this year.

美國淨貿易銷售額為 3.18 億美元，年增 127%，季增 5%。在美國，我們繼續認證更多醫院為授權治療中心，目前獲得 CARVYKTI 治療認證的美國醫院總數已達 114 家。我們對門診方面取得的進展感到滿意，並預計到今年年底我們的大部分診療量將來自門診。

Regarding OUS performance, which was notably strong, we had sales of $51 million which is more than double compared to the same period a year ago and represents a 65% increase quarter over quarter. Our OUS performance was driven by expansion in Germany, Switzerland, Austria, and Brazil, and we are pleased to be bringing CARVYKTI to more eligible patients in Spain, the UK, Denmark, Belgium, and Israel, where we recently launched.

OUS 的業績表現特別強勁，銷售額達 5,100 萬美元，較去年同期成長一倍多，較去年同期成長 65%。我們的 OUS 表現得益於在德國、瑞士、奧地利和巴西的擴張，我們很高興將 CARVYKTI 帶給最近在西班牙、英國、丹麥、比利時和以色列推出的更多符合條件的患者。

To this end, we're excited to see that Tech Lane initiated clinical production in Gante during the first quarter and remains on track to initiate commercial production there later this year. This is another critical component of our plans for serving patients in Europe to meet the increasing demand. And to meet additional demand in the United States, we expect to receive approval for our physical expansion and Raritan in the second half of the year.

為此，我們很高興地看到 Tech Lane 於第一季在 Gante 啟動臨床生產，並預計今年稍後在那裡啟動商業生產。這是我們為歐洲患者提供日益增長的需求服務計劃的另一個重要組成部分。為了滿足美國的額外需求，我們預計將在今年下半年獲得實體擴張和 Raritan 的批准。

The progress we've made in executing our manufacturing plan and investments has enabled us to be among the best-in-class. We now have a 97% manufacturing success rate, which we believe is the highest in the CAR-T industry. 95% of the time we deliver CARVYKTI on or before the promised delivery date, and our median turnaround time has been consistently declining and now stands at 30 days. We believe that turnaround time is more than sufficient based on our conversations with physicians. As physicians place their orders, they are mindful that bridging therapy alone takes multiple weeks for a number of patients.

我們在執行製造計劃和投資方面取得的進展使我們成為同類企業中最好的。現在我們的製造成功率為 97%，我們相信這是 CAR-T 產業中最高的。 95％ 的情況下，我們都會在承諾的交貨日期或之前交付 CARVYKTI，而且我們的平均週轉時間一直在下降，現在為 30 天。根據我們與醫生的對話，我們認為週轉時間是足夠的。當醫生下達醫囑時，他們注意到對許多患者來說，光是橋接療法就需要數週的時間。

Going forward, we expect to continue to reduce out of spec rates and increase our efficiency and expect further declines in our turnaround time. Now, it's time to take a closer look at the financials, so I will turn the call over to Jessie.

展望未來，我們預計將持續降低不合格率、提高效率，並預期週轉時間將進一步縮短。現在，是時候仔細看看財務狀況了，所以我將把電話轉給傑西。

Thank you, Alan, and good morning, everyone.

謝謝你，艾倫，大家早安。

During the first quarter, we delivered solid financial results with perfect net sales up 135% year over year. Total revenues were $195 million, driven by collaboration revenue growth of 137% year over year. Q1 delivered a $101 million net loss and a $27 million adjusted net loss after excluding items that are not representative of the company's core business, such as a$ 52 million unrealized foreign exchange loss due to our Treasury Center based in Ireland.

第一季度，我們取得了穩健的財務業績，淨銷售額年增 135%。總收入為 1.95 億美元，主要得益於合作收入年增 137%。第一季淨虧損 1.01 億美元，扣除不代表公司核心業務的項目（例如我們位於愛爾蘭的財務中心造成的 5,200 萬美元未實現外匯損失）後，調整後淨虧損為 2,700 萬美元。

Importantly, our operating loss of $180 million in the same period one year ago was reduced by over half to an operating loss of $51 million. The meaningful improvement in operating results was driven by our operational inefficiency and discipline expense management. Even though we continue to invest in a robust pipeline and supporting the second line indication launch as well as our manufacturing capacity, our first quarter growth margin on net product sales was 63%, improving from 59% in Q4.

重要的是，我們去年同期的營業虧損為 1.8 億美元，減少了一半以上，至 5,100 萬美元。經營績效的顯著改善得益於我們的營運效率和嚴格的費用管理。儘管我們繼續投資於強大的產品線並支持第二線適應症的推出以及我們的製造能力，但我們第一季的淨產品銷售額增長率為 63%，高於第四季度的 59%。

As expected, R&D expenses on an IFRS basis grew only 1% year over year, and SG&A on an IFRS basis only grew 29% from the prior year to $72 million. Overall, we believe we have been making strides towards positive operating cash flow generation and profitability. Our adjusted diluted earnings per share were negative $0.07 compared to negative $0.23 for the same period last year. Now, turning to capital allocation.

如預期的那樣，以 IFRS 計算的研發費用年比僅成長 1%，以 IFRS 計算的銷售、一般及行政費用較上年僅成長 29%，達到 7,200 萬美元。總體而言，我們相信我們已經在實現正向經營現金流產生和獲利方面取得了長足進步。我們的調整後每股攤薄收益為負 0.07 美元，去年同期為負 0.23 美元。現在，轉向資本配置。

We continue to have a strong balance sheet with $1 billion in cash equivalents and time deposits. We believe this is a competitive advantage for us in our industry, and we will continue to prioritize disciplined expense management as we fund our operating and capital expenditures, including future innovation, until we achieve profitability, which we anticipate in 2026, excluding unrealized foreign exchange gains or losses.

我們的資產負債表依然強勁，擁有 10 億美元的現金等價物和定期存款。我們相信這是我們在行業中的競爭優勢，我們將繼續優先考慮嚴格的費用管理，為我們的營運和資本支出（包括未來的創新）提供資金，直到我們實現盈利（我們預計在 2026 年實現盈利，不包括未實現的外匯收益或損失）。

In summary, our first quarter results demonstrate the durability of our stand-alone cell therapy platform. We are pleased with our performance and the advancements of many impactful initiatives, along with increasing operational efficiency in 2025. And now, it's time to take your questions. Operator, we are ready for the first question, please.

總之，我們的第一季業績證明了我們獨立細胞治療平台的耐用性。我們對我們的表現和許多有影響力的舉措的進步以及 2025 年營運效率的提高感到滿意。現在，我們來回答大家的提問。接線員，我們已經準備好回答第一個問題了。

(Operator Instructions)

（操作員指示）

Gena Wang, Barclays.

巴克萊銀行的 Gena Wang。

Thank you for taking my questions. I have three quick questions. The first one is regarding the CARVYKTI price differences between US and the ex-US, if you can give any color there. And the second is regarding the new Warrington section approval in second half '25, would you be able to walk us through the steps you need FDA sign off and any concern on FDA on-time execution? And then lastly, very quickly, I know you have a multiple pipeline assets. Just give us a a rough idea when should we see which program first in the coming years or 2025, we will see additional data.

感謝您回答我的問題。我有三個簡單的問題。第一個問題是關於美國和美國以外地區之間的 CARVYKTI 價格差異，如果您能提供任何詳細資訊的話。第二個問題是關於 2025 年下半年沃靈頓新部分的批准，您能否向我們介紹一下需要 FDA 簽字的步驟以及對 FDA 按時執行有何擔憂？最後，我很快得知，您擁有多個管道資產。請給我們一個大概的概念，我們應該在未來幾年或 2025 年首先看到哪個項目，我們將看到更多數據。

Hi, Gena. it's Alan. The price differential between the US and ex-US is approximately 30%, obviously, varies country to country. In terms of the rarity approval in the second half, we're confident that we will be able to achieve the approval from FDA in terms of capacity expansion, and that is based on the filings with them and the CB30 with that process.

你好，吉娜。是艾倫。美國和美國以外地區的價格差異約為 30%，顯然，各國的價格差異各不相同。就下半年的稀有批准而言，我們有信心獲得 FDA 在產能擴張方面的批准，這是基於向他們提交的文件以及該流程的 CB30。

So in terms of pipeline, our focus is on two different technology platforms, In Vivo cell therapy platform for oncology indication and the all genetic cell platform for autoimmune diseases. We are looking forward to our multiple clinical readout later this year. For the In Vivo CAR-T platform, we expect to have first patient dose investigator initiated the study in June or July and expect to have preliminary clinical result towards the end of this year. On the platform side, we expect to have a clinical results in the second half of this year against the investigating in this study.

因此，就產品線而言，我們的重點是兩個不同的技術平台，即用於腫瘤適應症的體內細胞治療平台和用於自體免疫疾病的全基因細胞平台。我們期待今年稍後的多項臨床讀數。對於體內CAR-T平台，我們預計第一位患者劑量研究人員將在六月或七月啟動研究，並預計在今年年底獲得初步臨床結果。在平台方面，我們預計今年下半年將根據這項研究的調查得出臨床結果。

Autoimmune currently, we are running some IT trial in China using the triple targeting or target cell therapy product targeting CD19, CD20, CD22, try to drive a different response. And we also expect to have a clinical result in the later part of the year.

目前，針對自體免疫，我們正在中國進行一些 IT 試驗，使用針對 CD19、CD20、CD22 的三重標靶或標靶細胞治療產品，嘗試引發不同的反應。我們也預計將在今年下半年獲得臨床結果。

Lastly, on the US side, we have two ongoing Phase 1 program targeting CLAUDIN 18.2 for gastric cancer and DR, small cell lung cancer. Again, we are reading out of the Phase 1 escalation data for both programs.

最後，在美國方面，我們有兩個正在進行的 I 期項目，分別針對胃癌和 DR（小細胞肺癌）的 CLAUDIN 18.2。再次，我們正在讀取這兩個程式的第一階段升級資料。

Yeah, I can expand on that a little bit. For the DLL 3 program, we have an oral presentation at ASGCT next week, and both the DLL 3 programs in the CLAUDIN 18 2. programs have (inaudible) posters and that you may have seen from the titles that were released back in April.

是的，我可以稍微詳細闡述。對於 DLL 3 程序，我們下週將在 ASGCT 上進行口頭報告，並且 CLAUDIN 18 2 中的兩個 DLL 3 程序都有（聽不清）海報，您可能已經從 4 月份發布的標題中看到過。

Hi, Gina. This is Ying, maybe I'll supplement the answers by pointing out two things. First of all, I know you guys are looking at the price difference, right? So you're pretty much aware that in the United States, there are three types of customers that we pay a mandatory Federal required rebate. So it's Medicaid, 340B hospitals, and also VA hospitals, right. We provide a 23.1% rebate to those customers from the list price, and this is why we don't see a really significant difference between the EUR price and those types of customers in the US. So we don't see a big impact regarding some of the proposals from the administration here.

你好，吉娜。我是 Ying，也許我會指出兩件事來補充答案。首先，我知道你們正在關注價格差異，對嗎？所以您很清楚，在美國，有三類客戶需要我們支付聯邦政府強制要求的回饋。所以它是醫療補助、340B 醫院，還有 VA 醫院，對吧。我們為這些客戶提供標價 23.1% 的折扣，這就是為什麼我們沒有看到歐元價格和美國這類客戶之間有顯著的差異。因此，我們認為政府的一些提議不會產生太大影響。

And then on FDA approval, I know people are concerned that you're seeing some staff reduction agency but based on our current interaction with FDA on expansion at (inaudible). Like Alan mentioned, FDA agreed that we'll use the so-called CB30 pathway. That is once we and file the application in writing within 30 days, if we don't hear from the agency, it's deemed approval, or if there's any request during that 30 days we can answer, then again, we don't expect any delays here. So we fully expect the on-time approval from FDA for the physical expansion rather than. And right now, we're still on track to achieve that by the end of this year.

關於 FDA 的批准，我知道人們擔心你會看到一些裁員機構，但根據我們目前與 FDA 在擴張方面的互動（聽不清楚）。正如艾倫所提到的，FDA 同意我們使用所謂的 CB30 途徑。也就是說，一旦我們在 30 天內以書面形式提交申請，如果我們沒有收到該機構的回复，則視為批准，或者如果在這 30 天內有任何請求，我們可以答复，同樣，我們不希望出現任何延誤。因此，我們完全期待 FDA 能夠按時批准物理擴張。目前，我們仍有望在今年年底前實現這一目標。

Jessica Fye, JP Morgan.

傑西卡費伊 (Jessica Fye)，摩根大通 (JP Morgan)。

Hey, guys, good morning. Thanks for taking my question. I was wondering if you could just take a minute to kind of make the case to investors that CARVYKTI will successfully penetrate the community. The reason I ask is one pushback we hear from investors is that when they do KOL calls, so with key centers, the physicians indicate they don't have a backlog and thus I think some investors come away thinking that demand is largely satisfied and there's limited growth ahead. So just hoping you can spend a minute on kind of making the case about why you have conviction this product can get into the community. Thank you.

嘿，大家早安。感謝您回答我的問題。我想知道您是否可以花一點時間向投資者說明 CARVYKTI 將成功滲透到社區。我之所以問這個問題，是因為我們聽到投資者反對的一個觀點是，當他們與關鍵患者中心進行電話溝通時，醫生們表示他們沒有積壓訂單，因此我認為一些投資者認為需求已基本得到滿足，未來的增長有限。所以我只希望您能花一點時間來解釋為什麼您確信該產品能夠進入社區。謝謝。

Based on many of the discussions we've had both with the KOL in the authorized treatment centers as well as physicians out in the community, there is a high demand for providing CARVYKTI as an option for patients in earlier lives. And what we hear is that the benefits based on the profile of extending survival, extending long-term remission to these patients is very attractive, and there are obviously, as you know, the majority of nearly 80% of the patients out there in the community.

根據我們與授權治療中心的關鍵意見領袖以及社區醫生進行的多次討論，我們發現，為早期患者提供 CARVYKTI 作為治療選擇的需求很高。我們聽說，基於延長生存期、延長長期緩解期的概況，這些療法對這些患者來說非常有吸引力，而且顯然，如您所知，社區中的大多數患者接近 80%。

What we have done is, and based on the feedback we've received is we've increased our investment and efforts along with J&J in terms of educating the community, going out and reaching all the major community sites, and we're in the process of doing that. And not only raising awareness, there's already high awareness of CARVYKTI as an option, but actually where we see more opportunities to raise awareness and increase that call to action in terms of referring patients into the authorized treatment centers.

我們所做的是，根據收到的回饋，我們與強生公司一起增加了投資和努力，對社區進行教育，走出去並接觸所有主要的社區網站，我們正在這樣做。不僅提高了認識，人們對 CARVYKTI 作為一種選擇的認識已經很高，而且實際上我們看到了更多機會來提高認識並增加在將患者轉診到授權治療中心方面的行動號召。

The second thing we're doing is we are connecting the experts in the authorized treatment centers with the experts out in the community, and this is getting a lot of great traction, a lot of increased dialogue, a lot of really good opportunities for those referrals to happen.

我們正在進行的第二件事是將授權治療中心的專家與社區中的專家聯繫起來，這正在產生很大的推動作用，增加很多對話，為這些轉診提供許多非常好的機會。

And then thirdly, we are explaining to the community that those patients are going to be coming back to them, and we are building a platform around transition of support so that those patients actually will need to get back to their community physician for ongoing monitoring, other health checks, and so that the community understands that they will not be losing those patients. So the profile of the product, the outpatient administration, the overall survival benefit, the unique differentiated benefit, these are all things that we see gaining traction in the community.

第三，我們向社區解釋這些患者將會回到他們身邊，我們正在圍繞支持過渡建立一個平台，以便這些患者實際上需要回到他們的社區醫生那裡進行持續監測和其他健康檢查，並讓社區明白他們不會失去這些患者。因此，產品概況、門診管理、整體生存效益、獨特的差異化效益，這些都是我們看到在社區中越來越受到關注的東西。

And just -- this is Ying. Maybe I'll just add one more point to Alan's comments. So we will present some long-term data at ASCO. In fact, you'll see the abstract coming out next week, and we and Ginger are extremely pleased with the results, and we think this will be actually another impetus for the community to take up CARVYKTI in the second line, given the unprecedented benefits.

這就是英。也許我只想對艾倫的評論再補充一點。因此我們將在 ASCO 上展示一些長期數據。事實上，您將在下週看到摘要，我們和 Ginger 對結果非常滿意，我們認為，鑑於其前所未有的好處，這實際上將成為社區在第二線採用 CARVYKTI 的另一個動力。

Also, I'm happy to report that our overall survival result was just added officially into the label in Europe following the CHMP opinion already. So again, in both the US market and European markets, we will be able to promote on the merit of overall survival and also the significant results from (inaudible) 4 that demonstrates both clinically meaningful and also statistically significant (inaudible) in survival over standard of care, so that will help the community uptake.

此外，我很高興地報告，我們的整體生存結果已根據 CHMP 的意見正式添加到歐洲的標籤中。因此，無論在美國市場還是歐洲市場，我們都能夠根據總體生存率的優點以及 (聽不清楚) 4 的顯著結果進行推廣，這些結果證明了在標準治療中生存率既具有臨床意義，也具有統計學意義 (聽不清楚)，因此這將有助於社區的接受。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Great, thanks so much. I've got two quick questions. Number one, in terms of capacity for Q2, now that obelisk is online and continuing to sort of you're pushing volume through it, should we expect -- can you give us a sense sort of we're expecting, obviously, a step up in terms of quarter-to-quarter growth over Q1? But is that going to be more European centric than the US? And then secondly, it sounds like you do not need to get the new Raritan facility inspected, the new expansion. Can you just confirm that? Thank you.

太好了，非常感謝。我有兩個簡單的問題。第一，就第二季度的容量而言，既然方尖碑已經上線，並且正在繼續通過它來推動容量，我們是否應該預期——您能否告訴我們，我們預期與第一季度相比，季度環比增長會有所提升？但這會不會更加以歐洲為中心，而不是以美國為中心？其次，聽起來你不需要對新的 Raritan 設施和新擴建進行檢查。能確認一下嗎？謝謝。

Yeah, so in terms of (inaudible), you're actually right, it came online in September of last year and it is now delivering for Europe. So we do expect that that will continue to improve our ability to supply Europe, and we do expect modest growth in Q2 with more sequential growth and acceleration of the back half of the year supported by not only (inaudible) but also the US capacity expansions as we've outlined previously with Raritan as well as Novartis coming online in the first half of this year.

是的，就（聽不清楚）而言，您實際上是對的，它於去年 9 月上線，現在正在向歐洲交付。因此，我們確實預計這將繼續提高我們向歐洲供貨的能力，並且我們確實預計第二季度將出現溫和增長，下半年將出現更多連續增長和加速，這不僅受到（聽不清）的支持，也受到美國產能擴張的支持，正如我們之前概述的那樣，Raritan 和 Novartis 將於今年上半年上線。

In terms of the in terms of the Raritan physical plant expansion as Ying described, at this point, we do not expect that there will be required any inspections relative to that CB30 process and the approval there.

就 Ying 所描述的 Raritan 實體工廠擴建而言，目前我們預計不需要對 CB30 流程和批准進行任何檢查。

Konstantinos Biliouris, BMO Capital Markets.

蒙特利爾銀行資本市場的 Konstantinos Biliouris。

Good morning, everyone. Thanks for taking our question. Can you remind us please what is the difference between high-risk patients and functional high-risk patients? What is the percentage of functional high-risk patients in Multiple Myeloma, and what percentage of the patients treated with CARVYKTI in early lines correspond to functional high-risk patients? Thank you.

大家早安。感謝您回答我們的問題。您能否提醒我們高風險患者和功能性高風險患者之間有什麼區別？多發性骨髓瘤中功能性高風險患者的比例是多少，早期接受CARVYKTI治療的患者中功能性高風險患者的比例是多少？謝謝。

Sure. When we refer to high-risk patients, we are referring to patients with certain cytogenetic factors, whereas the definition of functional high risk is more related to the concept that they progress quickly after sort of a frontline setting. So it's more related to how the patients respond to a particular therapy, In terms of the Cartitude 4 study, as the abstract titles show for ASCO, we will be having data coming out on the subgroup analysis of on these various patients in Cartitude 4. But in general, Cartitude 4 has shown very strong both PSS and OS in the population in these early lines of patients, so we feel confident that both of these populations, both high risk and functional high risk, do very well with still to sell administration.

當然。當我們提到高風險患者時，我們指的是具有某些細胞遺傳學因素的患者，而功能性高風險的定義則更多地與他們在一線環境後快速進展的概念相關。因此，這更與患者對特定療法的反應有關，就 Cartitude 4 研究而言，正如 ASCO 的摘要標題所示，我們將獲得關於 Cartitude 4 中這些不同患者的亞組分析數據。但總體而言，Cartitude 4 在這些早期患者群體中表現出了非常強勁的 PSS 和 OS，因此我們相信，這兩個群體，無論是高風險還是功能性高風險，在仍在銷售的管理下都會表現得很好。

And in terms of CARVYKTI uptake in early lines, what dynamics do you see there with functional high-risk patients? Is this a high percentage of such patients in the uptake that you see in early lines?

就早期 CARVYKTI 的吸收而言，您看到功能性高風險患者有何動態？在早期治療中，此類患者的比例高嗎？

Yeah. I think in the early lines, namely the second through fourth line, we do see that where physicians tend to start are in these categories that I just described the functional high risk and the high-risk patients. That's a natural place for them to begin to think about CARVYKTI as an option. But we've also in our conversations heard that many physicians, once they've gotten comfortable there and they have started to use it in that population will then expand. So I think to your point, this is a progression from utilizing CARVYKTI in the early lives for the patients who are either fast progressors or have the high side of genetic risk and then moving on from there.

是的。我認為在早期階段，即第二到第四線，我們確實看到醫生傾向於從我剛才描述的這些類別開始，即功能性高風險和高風險患者。他們很自然地開始考慮將 CARVYKTI 作為一種選擇。但我們在談話中也聽說，許多醫生一旦適應了這種療法並開始在人群中使用它，就會擴大其應用範圍。所以我認為，正如您所說，這是一個進步，即在早期對病情進展較快或具有較高遺傳風險的患者使用 CARVYKTI，然後從那裡繼續治療。

Kelly Shi, Jefferies.

Kelly Shi，傑富瑞集團。

Hi, good morning. This is Clara on for Kelly. Thanks for taking our questions. So you just initiated (inaudible) clinical production at the tackling facility. So just wondering if you can give us a little bit more color about the manufacturing expansion moving forward. And also, just want to quickly touch upon the In Vivo CAR-T initiative you mentioned, wondering where do you see the differentiations might land in this novel space? Thank you.

嗨，早安。我是克拉拉，代替凱利。感謝您回答我們的問題。因此，您剛剛在處理設施中啟動了（聽不清楚）臨床生產。所以我只是想問您是否可以向我們詳細介紹未來的製造業擴張情況。另外，我只想快速談談您提到的 In Vivo CAR-T 計劃，想知道您認為這個新領域的差異化可能體現在哪裡？謝謝。

Yes. As you mentioned, we achieved approval for the clinical production and began that in Tech Lane, and that sets us up well for the ability to start commercial production in Tech Lane by the end of this year, and we're on track for that. So between Tech Lane and the OLS facility, which is already approved in commercial, we are quite significantly ramping there to support the European launches. And just to remind you, the European launches are across Germany, Switzerland, Austria, Denmark, and then, throughout the world, we have the UK in private market, is in the private market, and Brazil as well. And as you saw from the release, Australia is now achieving approval reimbursement and launch will come later.

是的。正如您所提到的，我們獲得了臨床生產的批准，並在 Tech Lane 開始了生產，這為我們在今年年底前在 Tech Lane 開始商業化生產奠定了基礎，我們正按計劃進行。因此，在 Tech Lane 和已經獲得商業批准的 OLS 設施之間，我們正在大力推進以支持歐洲的發布。需要提醒您的是，我們的歐洲產品發布範圍遍及德國、瑞士、奧地利、丹麥，而在全球範圍內，我們的產品發布範圍還包括英國的私人市場，以及巴西。正如大家從新聞稿中看到的，澳洲目前正在獲得批准報銷，並將在稍後推出。

Just to add to the two facilities, again, as we've already mentioned, we've talked about the Raritan expansion and the Novartis commercial production, which started the first part of this year in January, is also starting to meaningfully contribute in Q2 here and then Q3 and beyond. In addition, let me just mention because we have talked about the fact that there is an investment in Tech Lane that the companies have jointly approved, and so that speaks to the additional capacity that we plan to build in Tech Lane to the tune of $150 million jointly by the collaboration.

除了這兩家工廠之外，正如我們已經提到的，我們討論了 Raritan 的擴建和諾華的商業化生產，這兩家工廠於今年 1 月份上半年開始生產，並且也開始在第二季度、第三季度及以後做出有意義的貢獻。此外，我想提一下，因為我們已經討論過，兩家公司已經共同批准了對 Tech Lane 的投資，這意味著我們計劃透過合作在 Tech Lane 共同投資 1.5 億美元來增加產能。

So in terms of In Vivo CAR-T approach, this is a platform where you -- we use molecular engineering, the antivirus that can specially recognize the immune cell. In this case, T cell in the body patient. At the same time, we also engineer a virus to reduce the generic or non-specific transaction to normal tissue, and we are expecting the first station those in in June and July this year.

因此，就體內 CAR-T 方法而言，這是一個平台，我們使用分子工程、可以專門識別免疫細胞的抗病毒藥物。在這種情況下，患者體內有 T 細胞。同時，我們也設計了一種病毒來減少對正常組織的通用或非特異性交易，我們預計第一站將在今年六月和七月。

In terms of advantage of In Vivo CAR-T compared to convention law Ex Vivo manufactured cell therapy, there are a few key areas. One is those things are engineered -- recognized engineering in the body of patient and therefore, in general, it have better self phenotype based on our preclinical data characterization. Second is completely off shelf without the need for depletion. So there's no delay in terms of administrating the therapy and no need for deletion also provide additional safety benefit to the patient. Lastly, it's a scalable manufacture due to the nature of lentivirus being the drug product. So those are the few key areas.

就In Vivo CAR-T與傳統Ex Vivo製造細胞療法相比的優勢而言，有幾個關鍵領域。一是這些東西是經過工程改造的——在患者體內經過公認的工程改造，因此，一般來說，根據我們的臨床前數據表徵，它具有更好的自我表型。第二種是完全現成的，無需消耗。因此，在治療管理方面不會延誤，也不需要刪除，還能為病人提供額外的安全效益。最後，由於慢病毒作為藥物產品的特性，它是一種可擴展的生產方式。這些就是幾個關鍵領域。

John Miller, Evercore ISI.

約翰·米勒，Evercore ISI。

Hi, guys. Thanks so much for taking the question. A couple of clarifications, if I may start with those. I know you already spoke about the general price difference US versus ex-US, but what's the price delta between the US and the lowest cost anywhere else in the world, not just the average difference?

嗨，大家好。非常感謝您回答這個問題。如果可以的話，我先澄清幾點。我知道您已經談到了美國與美國以外地區的一般價格差異，但美國與世界其他任何地方的最低成本之間的價格差異是多少，而不僅僅是平均差異？

And secondly, you talked a little bit about penetrating the community, but most of the stuff that you were talking about is how to get referrals into academic centers. I know you've also talked about getting actual CAR-T infusion into select community centers this year. Can you give us an update on how that process is going and how rapidly you expect to be able to deliver CAR-T in the community itself?

其次，您談到了一些關於滲透社區的問題，但您談論的大部分內容是如何獲得學術中心的推薦。我知道您也談到了今年將實際的 CAR-T 輸注引入選定的社區中心。您能否向我們介紹一下這一進程的進展以及您預計能夠多快在社區內推廣 CAR-T 療法？

And then maybe lastly on those In Vivo CAR-T differentiators that you that you just spoke of that makes sense relative to an Ex Vivo CAR-T, but how do you feel differentiated for your approach In Vivo space relative to other In Vivo players who are also working on similar lenty-based approaches? Thank you.

最後，也許您剛才談到的體內 CAR-T 差異化因素相對於體外 CAR-T 是有意義的，但是您認為您的體內方法與其他同樣採用類似基於劑量方法的體內參與者相比有何不同？謝謝。

This is Alan. I don't think we'll be commenting on the specific lowest price, but I do want to just remind you that we have a band, a pricing band that J&J, given their pricing policy, does adhere to, so we don't go below that price. And that's supported basically based on the costs and other factors, obviously, speaking to the value of car safety in the marketplace as well. So there is a price there.

這是艾倫。我認為我們不會對具體的最低價格發表評論，但我確實想提醒您，我們有一個價格區間，強生公司根據其定價政策遵守該價格區間，因此我們不會低於該價格。這基本上是基於成本和其他因素的支持，顯然也說明了汽車安全在市場上的價值。所以這是有代價的。

You're absolutely right that I was speaking to the penetrating of the community in terms of referral base, but to add to that, we are also in active discussions around having perfectly closer to the patient and administered in the community setting. We have several, I would say sort of demonstration projects and initial plans with certain community centers this year in the works. Nothing to announce as of yet, but we do expect that this year, we'll have at least one if not two or more community -- large community networks starting to administer CARVYKTI in some of their centers.

您說得完全正確，我所說的是在轉診基礎方面對社區的滲透，但除此之外，我們還在積極討論如何在社區環境中更貼近患者並進行管理。我想說，我們今年正在與某些社區中心合作幾個示範計畫和初步計畫。目前還沒有任何消息可以宣布，但我們確實預計，今年我們將至少有一個（如果不是兩個或更多）社區——大型社區網絡開始在其一些中心管理 CARVYKTI。

And then the third leg of that journey, if you will, is actually bringing it to even more sites around the country and having CARVYKTI adopted in the community setting as well. So we are on that journey starting with some centers this year.

那麼，如果你願意的話，這段旅程的第三站實際上是將它帶到全國更多的地點，並讓 CARVYKTI 也在社區環境中被採用。因此，我們從今年的一些中心開始踏上這趟旅程。

Yeah, I'm getting to your second question in terms of differentiation of our In Vivo approach versus our peer groups approach across the industry. This is a novel platform and rapidly evolving. We began to invest in this platform two years ago. We think that there are probably four or five areas of key differentiation that we actually set up from the get-go.

是的，我想回答你的第二個問題，關於我們的 In Vivo 方法與整個行業中同行方法的區別。這是一個新穎的平台，並且正在快速發展。我們兩年前就開始投資這個平台。我們認為，我們從一開始就確定了四到五個關鍵的差異化領域。

One is on the T cell recognition mechanism. So there are many different ways to recognize T cell and then induce the transaction. We are testing multiple mechanisms of T cell recognition and to drive the transaction efficiency as well as to control the safety signal. Those approach we invested will play out in the setting.

一是T細胞辨識機制。因此，有許多不同的方法來識別 T 細胞並誘導交易。我們正在測試 T 細胞識別的多種機制，以提高交易效率並控制安全訊號。我們所投入的方法將會在環境中發揮作用。

The second area of differentiation is really about the engineering venting virus, reducing the generic transduction capacity of virus. We have specific point mutations with our own IP position to really reduce the generic transaction and therefore expand the potential therapeutic window between the T cell recognition and non-specific recognition.

第二個區別領域其實是關於病毒的工程排氣，降低病毒的通用傳導能力。我們擁有具有自身智慧財產權的特定點突變，可以真正減少通用交易，從而擴大 T 細胞識別和非特異性識別之間的潛在治療窗口。

The third area is the CAR design. We have large experience and the expertise in optimizing the CAR design, com combined with armor mechanisms. So I think that's a key area that can drive the differentiation and the activity of the In Vivo CAR-T.

第三個領域是CAR設計。我們在優化 CAR 設計並與裝甲機制相結合方面擁有豐富的經驗和專業知識。所以我認為這是推動體內 CAR-T 差異化和活性的關鍵領域。

The fourth area is another area we have a tremendous expertise coming from committee's experience that is the CMC. The process development, process robustness and the ability to scale up. I found the get our goal is to optimize the CMC process so that we can not only support the initial (inaudible) try but also have the ability to further develop down the road.

第四個領域是我們從委員會的經驗中獲得了豐富的專業知識的另一個領域，即 CMC。流程開發、流程穩健性和擴大規模的能力。我發現我們的目標是優化 CMC 流程，以便我們不僅可以支援最初的（聽不清楚）嘗試，而且還有能力在未來進一步發展。

And then last area, the fifth area of differentiation, we focus on is really the execution of validation for those platforms. We have end-to-end capacity in development on the ground in China. We can execute the (inaudible) try very efficiently. Our first development candidate for In Vivo platform was selected last December and six months later, we are looking forward to first patient dosing. So let's speak to the speed and efficiency of our clinic development process. All those, I think we bring value to our (inaudible).

最後一個領域，即第五個差異化領域，我們真正關注的是這些平台的驗證執行。我們在中國擁有端到端的本地開發能力。我們可以非常有效地執行（聽不清楚）嘗試。我們針對 In Vivo 平台的第一位開發候選藥物於去年 12 月被選中，六個月後，我們期待第一位患者用藥。那麼讓我們來談談我們的診所發展過程的速度和效率。所有這些，我認為我們是我們的（聽不清楚）。

Leonid Timashev, RBC.

列昂尼德·蒂馬舍夫（RBC）。

Hey, thanks, guys. Thanks for taking my question. I wondered if you could talk a bit more about the community referral process. I guess, I'm wondering how much brand awareness and stickiness actually is there in the community for CARVYKTI specifically versus that decision being made at other centers. I guess, effectively, are you laying the groundwork for CARVYKTI or for all CAR-Ts, including I guess, future and current competitors? And then related to that, I guess what's the messaging from you and your partner in the community given that your commercialization partner also has buy specific offerings which are pretty popular in the community. Thanks.

嘿，謝謝大家。感謝您回答我的問題。我想知道您是否可以再多談談社區推薦流程。我想，我想知道的是，與其他中心做出的決定相比，社群對 CARVYKTI 的品牌知名度和黏性到底有多大。我猜，實際上，您是在為 CARVYKTI 或所有 CAR-T 奠定基礎，包括未來和現在的競爭對手？與此相關，鑑於您的商業化合作夥伴也購買了在社區中非常受歡迎的特定產品，我想您和您的社區合作夥伴想要傳達什麼訊息。謝謝。

Yeah, there's growing awareness of CAR-T and specifically CARVYKTI in the community. We estimate, we do some surveys that about 70% of community oncologists are aware of CARVYKTI. Where we see more opportunity is actually to get them to kind of go from awareness to action based on the earlier line approval of the CAR-T 4 population. But we are certainly laying the groundwork for that in the ways that I described earlier in terms of strong education through our field teams, through medical education, through connecting the experts at the treatment centers to the community and making sure that the community understands that they will be getting their patients back for a transition of support and monitoring and ongoing care.

是的，社區對 CAR-T 尤其是 CARVYKTI 的認識正在不斷提高。我們估計，我們做了一些調查，大約 70% 的社區腫瘤學家都知道 CARVYKTI。我們看到的更多機會實際上是讓他們根據 CAR-T 4 人群早期的批准，從意識到行動。但我們確實正在以我之前描述的方式為此奠定基礎，即透過我們的實地團隊進行強有力的教育，透過醫學教育，透過將治療中心的專家與社區聯繫起來，並確保社區了解他們將把患者帶回來接受支持、監測和持續護理的過渡。

In terms of -- I think that was the answer on that. The messaging with the partner, yeah. So we and our partners are very committed to the fact that cell therapy, specifically BCMA CAR-T, is the very best option for patients in terms of earlier lines. We have the overall survival data, we have the durability, and the IMWG recommendations are very clear that for patients who are eligible for both by specifics and CAR-T should really be evaluated for CAR-T first, and that's based on the clinical profile. J&J is committed to this, and I should just remind you that we have our own teams out in the field, our own sales teams dedicated to CARVYKTI both on the J&J side and on the Legend side making this case.

就這一點而言——我認為這就是答案。是的，與合作夥伴進行訊息傳遞。因此，我們和我們的合作夥伴堅信細胞療法，特別是 BCMA CAR-T，是早期患者的最佳選擇。我們有整體存活數據，我們有耐久性，並且 IMWG 建議非常明確，對於符合具體情況和 CAR-T 治療條件的患者，應該首先對 CAR-T 進行評估，這是基於臨床特徵的。強生公司致力於此，我應該提醒您，我們在該領域擁有自己的團隊，強生公司和傳奇公司都有自己的銷售團隊致力於 CARVYKTI 的銷售。

Vikram Purohit, Morgan Stanley.

摩根士丹利的維克拉姆·普羅希特（Vikram Purohit）。

Hi, good morning. Thank you for taking our questions. We have wo. So first, can you just kind of walk us through your in your initial thoughts on the recently appointed leadership at CDER and what you see as the potential implications and key considerations here that we should keep in mind for the CDER development program. And then secondly, related to an earlier question, could you remind us what portion of CARVYKTI use is currently in the Cartitude 4 population and where do you see that trending over, say, the course of the next year? Thank you.

嗨，早安。感謝您回答我們的問題。我們有女人。首先，您能否向我們介紹一下您對 CDER 最近任命的領導層的初步想法，以及您認為在 CDER 發展計劃中我們應該牢記的潛在影響和關鍵考慮因素。其次，與先前的問題相關，您能否提醒我們，目前在 Cartitude 4 人群中，CARVYKTI 的使用比例是多少，以及您認為這種趨勢在未來一年會如何發展？謝謝。

And just to answer your second question first, we see that nearly 60% of our patients, and this is based on our ordering system, nearly 60% are coming from that Cartitude 4 population. We expect that to continue to evolve in that direction and get to about three quarters either by the end of this year or certainly before our competitor in this space is launched. So again, as they get into the market in a later land population, we will have significantly evolved our business into the earlier lines.

首先回答您的第二個問題，根據我們的訂購系統，我們發現近 60% 的患者來自 Cartitude 4 人群。我們預計這一趨勢將繼續發展，並在今年年底或在該領域的競爭對手推出之前達到約三個季度。因此，當他們進入後期土地市場時，我們的業務將顯著發展到早期的路線。

Hey, Vikram, so I'll answer the question about the new CDER leadership at FDA. So we're happy to see that Dr. Prasad has been appointed the director of CDER, which regulates all the cell and gene therapy approvals. First of all, we agree with Dr. Prasad's point that in any cancer trial, you should use gold standard of survival benefit. And to that end, we're happy to report that first of all, we will report long-term minimum five-year fallout from (inaudible)1, and you guys will see the data at ASCO. In fact, the assets coming out next week, so you'll see the unprecedented benefit we bring to this population, and that is survival, which is a hard endpoint, right?

嘿，維克拉姆，我來回答有關 FDA 新 CDER 領導層的問題。因此，我們很高興看到 Prasad 博士被任命為 CDER 主任，該機構負責監管所有細胞和基因治療的批准。首先，我們同意 Prasad 博士的觀點，在任何癌症試驗中，都應該使用生存效益的黃金標準。為此，我們很高興地報告，首先，我們將報告（聽不清楚）1 的長期至少五年影響，你們將在 ASCO 看到數據。事實上，資產將於下周公布，所以你會看到我們為這個群體帶來的前所未有的好處，那就是生存，這是一個硬終點，對吧？

Secondly, I think if you look at the history of CARVYKTI approval, we did secure FDA approval back in February of 2022 based on the prime endpoint of overall response rate. However, when we started the trial back in 2018, 2019, these patients have exhausted all the available therapy to them, so it represents a very significant on mathematical need by then. Today, of course, you can argue things are different because you have 2 BCMA targeting CAR-T available as commercial therapy and 3 soon to be 4 by 3 antibodies again indicated for myeloma so it's very different. But since we conducted that trial, we have demonstrated the survival benefit. We have demonstrated the PFS, which is nearly three years from historically about four to five months in this patient population. So that is the hard evidence we demonstrated.

其次，我認為，如果你回顧一下 CARVYKTI 批准的歷史，我們確實在 2022 年 2 月根據總體反應率的主要終點獲得了 FDA 的批准。然而，當我們在 2018 年、2019 年開始試驗時，這些患者已經用盡了所有可用的治療方法，因此到那時，這在數學上的需求非常大。當然，今天你可以說情況有所不同，因為有 2 種 BCMA 靶向 CAR-T 可用作商業療法，還有 3 種即將成為 4x3 的抗體再次用於治療骨髓瘤，所以情況非常不同。但自從我們進行那次試驗以來，我們已經證明了生存益處。我們已經證明了 PFS，對於該患者群體來說，PFS 從歷史上的四到五個月縮短了近三年。這就是我們所展示的確鑿證據。

And then thirdly, we also secured both FDA and also EMA approval based on TFS standpoint. However, in September of last year, we demonstrated, again, clinically meaningful and also specifically significant benefit in survival with has a ratio of 0.55%, which means 45% improvement in survival from standard of care. So we think CARVYKTI comes with a very strong benefit in terms of clinical outcome with survival, and then that's also accompanied by the surge endpoints such as PFS and overall response rate, right? That is why Legend and also J&J stands by the best-in-class profile. So we welcome Dr. Prasad as the CDER leadership because we have clearly demonstrated the survival benefit here.

第三，從 TFS 的角度來看，我們也獲得了 FDA 和 EMA 的批准。然而，去年 9 月，我們再次證明了具有臨床意義且特別顯著的生存獲益，其比例為 0.55%，這意味著生存率比標準治療提高了 45%。因此，我們認為 CARVYKTI 在臨床結果和存活率方面具有非常強大的優勢，並且還伴隨著 PFS 和整體反應率等激增終點，對嗎？這就是為什麼 Legend 和 J&J 都保持著一流的形象。因此，我們歡迎 Prasad 博士擔任 CDER 領導，因為我們已經清楚地證明了生存優勢。

Now, I know there are questions from investors about MRD connectivity. So we think that given the support from ODA last year using MRDA as a survey endpoint. We plan to sit down with the FDA to explore the possibility of using MRD activity as a potential end point for accelerated approval. We think this is a good study in the first line study because as you know, today, it's a newly diagnosed multiple myeloma patient is treated. Expected survival is probably over five to seven years. Therefore, in this setting, a surrogate input makes perfect sense.

現在，我知道投資者對 MRD 連接性有一些疑問。因此我們認為，鑑於去年 ODA 的支持，使用 MRDA 作為調查終點。我們計劃與 FDA 坐下來探討使用 MRD 活動作為加速批准的潛在終點的可能性。我們認為這是第一線研究中的一項很好的研究，因為如你所知，今天，一位新診斷的多發性骨髓瘤患者正在接受治療。預期存活期大概為五至七年。因此，在這種情況下，替代輸入非常有意義。

Now, in the last line or even second line. If you look at our data from CAR 4, right, the standard of cure had a PFS of shorter than one year. So in that setting, we're not sure whether a surrogate end point makes sense or not under the leadership of Dr. Prasad. As I mentioned again, we agree that in oncology studies survival should be the gold standard, and we're happy to report that CARVYKTI does bring that life-saving benefit to patients.

現在，在最後一行甚至第二行。如果您查看我們來自 CAR 4 的數據，那麼治癒標準的 PFS 短於一年。因此，在這種情況下，我們不確定在普拉薩德博士的領導下替代終點是否有意義。正如我再次提到的，我們一致認為，在腫瘤學研究中，存活率應該是黃金標準，我們很高興地報告，CARVYKTI 確實為患者帶來了挽救生命的好處。

James Shin, DB.

詹姆斯·辛，DB。

Hey, good morning, guys. Thank you for taking our question. I want to kind of piggyback on the Dr. Prasad question. I know base case for card 26 is to lean on PFS, and it sounds like you have engaged on possibly exploring MRD, but any thoughts on like competitors or the utilization of a percentage of patients completing 12 months of follow up. And then for Alan, what is the status on like, I believe there was an industry coalition for lowering community-based CAR-T accreditation is that, I guess, called a bottleneck for community adoption right now? Thank you.

嘿，大家早安。感謝您回答我們的問題。我想順便提一下普拉薩德博士的問題。我知道卡 26 的基本情況是依靠 PFS，聽起來您可能已經開始探索 MRD，但對於競爭對手或完成 12 個月隨訪的患者比例的利用率有什麼想法嗎？那麼對艾倫來說，目前的狀況如何？我相信有一個產業聯盟致力於降低社區為基礎的 CAR-T 認證，我猜這被稱為目前社區採用的瓶頸？謝謝。

Regarding your first question, unfortunately, if we do not comment on competitors, I can't say what they are doing. We're confident about our approach and discussions that we will be having on with the FDA on our on our cards base study.

關於您的第一個問題，不幸的是，如果我們不評論競爭對手，我就無法知道他們在做什麼。我們對我們的方法以及與 FDA 就我們的卡片基礎研究進行的討論充滿信心。

Yeah, the industry discussions around providing some sort of fact light accreditation are ongoing. There are some centers we are in discussions with that, and they are affiliated with the larger academic centers around the country, so that I would say is in process and that should potentially unlock some of the opportunities in the community as well.

是的，業界正在就提供某種事實認證進行討論。我們正在與一些中心進行討論，它們隸屬於全國各地較大的學術中心，因此我認為這項工作正在進行中，也有可能為社區帶來一些機會。

In addition, just to add to the CARVYKTI, as I mentioned, we have a clear plan to have conversations with the FDA, and we intend on meeting with them in about two-month time frame.

此外，正如我所提到的，補充一下 CARVYKTI，我們有一個與 FDA 進行對話的明確計劃，我們打算在大約兩個月的時間內與他們會面。

Mitchell Kapoor, H.C. Wainright.

米切爾·卡普爾，H.C.溫賴特。

Hey, everyone. Thanks for taking the questions. I wanted to ask one about outpatient volume. I think last quarter, you'd mentioned that it comprised over half of all volume for CARVYKTI. Can you quantify that trend now and just give us a little bit of the direction of where that is heading? And then secondly, can you talk through your assumptions and pipeline efforts for cash runway through second quarter of 2026? Would you need to seek some avenues of non-diluted capital to bridge yourself like well into profitability, or do you think that maybe there are some other opportunities you might seek?

嘿，大家好。感謝您回答這些問題。我想問一下門診量的情況。我想上個季度，您提到它佔 CARVYKTI 總銷售量的一半以上。您現在能量化這一趨勢並告訴我們其發展方向嗎？其次，您能否談談對 2026 年第二季現金流的假設和準備？您是否需要尋求一些非稀釋資本的途徑來實現盈利，或者您認為也許還有其他一些機會可以尋求？

In terms of outpatient volume, we see that growing steadily but slowly also because as new centers come on, sometimes they start in the inpatient. So our latest claims data continues to show that it's a little over half. We do see growth each quarter, but it's kind of in the single-digit percentage points.

就門診量而言，我們看到其穩定增長，但速度緩慢，因為隨著新中心的出現，有時它們從住院病人開始。因此，我們最新的索賠數據繼續顯示，這一數字略高於一半。我們確實看到每個季度都有成長，但增幅都只有個位數百分點。

I expect that over time, we will continue to see continued move to the outpatient setting. Again, this might be center specific, or it might be patient specific depending on the patient characteristics, but I would say we probably get into kind of the two-thirds, one-third outpatient versus inpatient over time with the treatment centers that we have now and the ones that will be coming on board in the future.

我預計，隨著時間的推移，我們將繼續看到向門診環境的轉變。再次，這可能是特定於中心的，也可能是特定於患者的，這取決於患者的特徵，但我想說，隨著時間的推移，我們可能會將現在的治療中心和未來將要加入的治療中心的門診患者與住院患者的比例控制在三分之二或三分之一。

And Mitchell, as you know, we have many reasons to be optimistic about Legend's future, and we are the market leader with the fastest launch in the CAR-T space, and we continue to expect CARVYKTI will break even operationally by the end of '25, and we anticipate profitability in 2026, excluding FX fluctuations. We have $1 billion of cash on. And that will reach profitability when we that will last till 2026. So we don't have any pressing needs to raise capital and we have a joint investment with J&J on CapEx for $150 million that will last for 2028 for the Tech Lane Phase 2 expansion and that is included in our cash runway.

米切爾，如您所知，我們有很多理由對 Legend 的未來感到樂觀，我們是 CAR-T 領域推出速度最快的市場領導者，我們繼續預計 CARVYKTI 將在 2025 年底實現收支平衡，我們預計 2026 年將實現盈利（不包括外匯波動）。我們有10億美元現金。到 2026 年，我們才能獲利。因此，我們沒有任何迫切的籌集資金的需求，並且我們與強生公司聯合投資了 1.5 億美元的資本支出，用於Tech Lane 第二階段擴建，將持續到 2028 年，這筆資金包含在我們的現金流中。

(inaudible) BTIG.

（聽不清楚） BTIG。

Great, thanks for taking my questions. Just two from me. First, coming back to integrating CAR-T therapy into the community setting, when it comes to the tertiary and regional centers, what are the biggest infrastructure hurdles for them currently and what are you doing to facilitate this? And second, on the DLL3 and CLAUDIN 18.2 data sets we're expecting, will the data be as part of the conference abstracts, or will they perhaps be saved for the conference presentations themselves? Thank you.

太好了，感謝您回答我的問題。我只差兩個。首先，回到將 CAR-T 療法融入社區環境的話題，對於三級和區域中心來說，他們目前面臨的最大基礎設施障礙是什麼？您正在採取哪些措施來促進此目標的實現？其次，對於我們期望的 DLL3 和 CLAUDIN 18.2 資料集，這些資料將作為會議摘要的一部分，還是可能會保存用於會議演示本身？謝謝。

In terms of infrastructure, certainly, capacity and chair space and staff are some of the factors that we look at. But again, speaking to the prior question around outpatients, we do see that over half of our patients are getting perfectly in the outpatient setting, and that's based on a couple of factors. One of which importantly is our profile around the time of onset for CRS and that gives the centers confidence to safely infuse it in the community and then monitor patients, and that opportunity for outpatients is one of the ways that we overcome some of the infrastructure hurdles there.

在基礎設施方面，容量、座位空間和工作人員當然是我們考慮的一些因素。但是，再次談到有關門診病人的先前問題，我們確實看到超過一半的病人在門診環境中得到了完美的治療，這是基於幾個因素。其中最重要的是我們對 CRS 發病時間的了解，這讓中心有信心將其安全地註入社區，然後監測患者，而為門診患者提供機會是我們克服那裡的一些基礎設施障礙的方法之一。

One of the other infrastructure hurdles that we are monitoring, and we keep a close conversation on with our centers is any capacity limits in terms of pickups and apheresis and cryopreservation. Again, there are multiple ways that centers around the country are addressing this, including use of third-party suppliers for apheresis pickup as well as cryopreservation, and we're engaging those companies to help make sure that those infrastructure hurdles are not a limit to patients getting a (inaudible)

我們正在監控的另一個基礎設施障礙是取血、血液分離和冷凍保存方面的容量限制，我們也正在與我們的中心保持密切溝通。再次強調，全國各地的中心正在採取多種方式解決這個問題，包括使用第三方供應商進行血液採集和冷凍保存，我們正在與這些公司合作，以確保這些基礎設施障礙不會成為患者獲得（聽不清楚）

Regarding DLL3 and CLAUDIN 18.2, as I mentioned, DLL3 will have an oral presentation at ASGCT next week regarding the ASCO abstracts. There will be key data from the dose escalation in both studies that will be available next week when the abstracts are released and look forward to providing more details at the conference itself.

關於 DLL3 和 CLAUDIN 18.2，正如我所提到的，DLL3 將於下週在 ASGCT 上就 ASCO 摘要進行口頭報告。兩項研究中劑量遞增的關鍵數據將於下週摘要發佈時提供，並期待在會議期間提供更多細節。

Ash Verma, UBS.

瑞銀的 Ash Verma。

Hey, yeah, thanks for taking our questions. So maybe just on CARVYKTI, so I know you've talked about second quarter as a step up since the what the supply comes online. Is that a step up more of the magnitude what we saw in the third quarter of last year, which was a pretty robust, sequential growth quarter for you? And then secondly, any thoughts you can share on the potential upcoming clinical data from our select? We saw 98 patients of data at the at the ASH conference and presumably now getting 19 additional patients with more than two months of follow up. So do you think that there can be any non (inaudible) talks that can show up in the upcoming update? Thanks.

嘿，是的，感謝您回答我們的問題。所以也許只是關於 CARVYKTI，所以我知道您已經談到第二季度是自供應上線以來的一個進步。這是否比去年第三季的增幅更大？去年第三季對您來說是一個相當強勁的連續成長季度？其次，您能分享我們選擇的潛在即將發布的臨床數據嗎？我們在 ASH 會議上看到了 98 名患者的數據，據推測現在又有 19 名患者的數據進行了兩個多月的追蹤。那麼，您認為在即將發布的更新中會出現任何非（聽不清楚）的對話嗎？謝謝。

The step up for Novartis is now starting to contribute to our capacity expansion towards our goal of 10,000 doses by the end of this year, and we feel very confident with that target of providing the ability to supply 10,000 annualized patient doses. In terms of size of the step-ups and size of growth, I think we're projecting that Q2 will be another modest step up in terms of our growth based on demand and supply with sequential growth and then further acceleration in the back half of the year.

諾華的進步現在開始促進我們的產能擴張，朝著今年年底 10,000 劑的目標邁進，我們對提供每年 10,000 劑患者劑量的能力這一目標非常有信心。就提升規模和成長規模而言，我認為我們預計第二季我們的成長將再次適度提升，基於需求和供應，實現連續成長，然後在下半年進一步加速。

Just in terms of some of the dynamics for Q1, I think one of the reasons why we saw a solid 10% growth, not only because of the European markets coming online, but also based on some of the improvements we saw in (inaudible) with turnaround time and our Obelisk facility ramping a little bit faster than we expected. This is just great execution from our team in Europe to supply the European launches, and that helped pull in some of the revenue from what we were projecting for Q2 into Q1 for a solid Q1 performance.

僅就第一季的一些動態而言，我認為我們實現 10% 穩健成長的原因之一，不僅是因為歐洲市場開始上線，還基於我們在周轉時間方面看到的一些改進（聽不清楚），而且我們的方尖碑工廠的產能提升速度比我們預期的要快一些。這是我們歐洲團隊為歐洲新產品發布提供的出色執行，有助於將我們預計的第二季度的部分收入帶入第一季度，從而實現穩健的第一季業績。

Regarding your second question on the clinical data from RFlex, I can't comment on what's going to be presented besides just the title aspect that we are aware of at ASCO. And what I can say is that or whether they'll have any evidence of neurotoxin in their studies, they are obviously starting a Phase 3 randomized study and so I think that will be very telling about more of their safety profile.

關於您關於 RFlex 臨床數據的第二個問題，除了我們在 ASCO 上了解到的標題方面之外，我無法評論將會呈現什麼。我可以說的是，無論他們的研究中是否有神經毒素的證據，他們顯然正在開始第三階段的隨機研究，所以我認為這將非常能說明他們的安全性。

What I can say is regarding our study, we're very excited about the ASCO presentation of a protitude one long-term data set. I think you'll be pleasantly excited as well when you see the data being presented. In addition, I can also say that our monitoring of the absolute lymphocyte count or ALC and the use of prophylactic steroids with ALC counts of greater than 3,000 is being further incorporated into major academic centers and as well as in our Cartitude studies and we're seeing good response from the KOLs who are implementing this, and we expect additional data to come out later this year so we will report on that in the near future.

關於我們的研究，我可以說的是，我們對 ASCO 展示的 protitude 一長期資料集感到非常興奮。我想當您看到所呈現的數據時，您也會感到高興和興奮。此外，我還可以說，我們對絕對淋巴細胞計數或 ALC 的監測以及 ALC 計數大於 3,000 時使用預防性類固醇的做法正在被進一步納入主要學術中心以及我們的 Cartitude 研究，我們看到實施這一做法的 KOL 做出了良好的反應，我們預計今年晚些時候會有更多的數據出來，因此我們將在不久的將來報告。

George Farmer, Scotiabank Airlines.

喬治法默 (George Farmer)，加拿大豐業航空公司。

Hi, good morning. This is Chloe on for George. Thank you for squeezing us in, a couple from us. So I wanted to double click on the survey number that you mentioned earlier about the preference from (inaudible) in the second line, prescribing the second line, rising from 34% to 55%. I was wondering if you could provide a little bit more color here on the diversity or the geographical -- geographic location or volume of the centers where these monks are operating at and what they need to see to keep pushing beyond that 55%? And if you could also comment on uptake in this early line setting in the EU if you expect the updated label to have a significant impact there on early airline use.

嗨，早安。這是克洛伊 (Chloe) 代替喬治 (George) 上場的。謝謝你們抽空給我們，我們是一對夫妻。因此，我想雙擊您之前提到的關於第二行中（聽不清楚）的偏好的調查數字，規定第二行從 34％ 上升到 55％。我想知道您是否可以提供更多關於這些僧侶所從事活動的中心的多樣性或地理位置或數量的詳細信息，以及他們需要看到什麼才能繼續超越 55% 的水平？如果您預計更新的標籤會對早期的航空使用產生重大影響，您是否也可以評論一下歐盟早期航線的採用情況？

Also wanted to ask about outpatient administration, you did say it's a little over 50% now. And could you maybe break that down for us between the earlier and the and the end stage disease, like in your second to fourth patients, what proportion of those are being treated in outpatient versus in patient and how does that compare to the end-stage patients?

也想問門診管理的情況，您確實說過現在門診管理率略高於 50%。您能否為我們細分早期和末期疾病，例如在第二到第四位患者中，接受門診治療和住院治療的比例是多少，與終末期患者相比如何？

And a last question if I may, just to clarify when you specify the turnaround time is around 30 days for CARVYKTI, are you using that kind of interchangeably with vein-to-vein time here?

如果可以的話，我還有最後一個問題，請澄清一下，當您指定 CARVYKTI 的周轉時間約為 30 天時，您是否在這裡將其與靜脈到靜脈的時間互換使用？

Yes. So first of all, in terms of the EU, we do expect that the updated label will support the use in the earlier lines and that's the feedback we've been getting from the centers in Germany that are now online and in the other European markets as we mentioned. So we do expect that it's the overall survival data that is very compelling and this will enable patients, much like it has in the US, to sort of move into the earlier treatment settings with CARVYKTI.

是的。因此，首先，就歐盟而言，我們確實希望更新後的標籤將支援早期生產線的使用，這是我們從現在上線的德國中心和其他歐洲市場得到的回饋，正如我們所提到的。因此，我們確實預期整體存活數據非常引人注目，這將使患者能夠像在美國一樣，進入使用 CARVYKTI 的早期治療環境。

In terms of outpatient, we don't have a specific breakdown between how much of the outpatient uses in the earlier line versus the end stage, but I -- qualitatively, I will tell you that as we get into more patients receiving CARVYKTI in the earlier lines, that does correlate somewhat with the ability and the comfort level with additions to administer in the outpatient setting. Although the outpatient setting is more a factor of sort of safety monitoring and we do see, again, in the earlier lines, a lower rates of CRS and lower rates of MMTs. And so, these are the things that physicians do gain comfort with as they as they move to earlier lines.

就門診而言，我們沒有對早期和晚期門診用藥量進行具體細分，但我——從質量上講，我會告訴你，隨著我們在早期階段接受 CARVYKTI 治療的患者越來越多，這確實與門診環境中添加藥物的能力和舒適度有一定相關性。儘管門診環境更多是一種安全監測因素，但我們確實在早期看到了 CRS 發生率和 MMT 發生率較低。因此，這些都是醫生在轉向早期治療時確實感到安心的事情。

In terms of turnaround time, our media 30 days, everyone uses a bit of a different definition in terms of what vein to vein is, but we think this is the most relevant way to think about our ability to deliver to physicians because this is the point at which they (inaudible) the patient and then when is the product available for them to take it back and infuse patients. And as we discussed on the presentation, because of bridging therapy, this is a very acceptable, I wouldn't say even acceptable, I would say comfortable place for physicians to be by the time they get through the bridging therapy that most patients are going to receive. Whether that's in later lines or in earlier lines, we're really at the 30-day mark. And so, turnaround time is quite competitive to where physicians needed to be at this point, but we do expect that we'll continue to be able to reduce that over time.

就週轉時間而言，我們的媒體是 30 天，每個人對靜脈到靜脈的定義都有點不同，但我們認為這是思考我們向醫生提供服務的能力最相關的方式，因為這是他們（聽不清楚）患者的時間點，然後他們什麼時候可以將產品帶回去並輸注給患者。正如我們在演講中討論的那樣，由於橋接療法，當醫生完成大多數患者將要接受的橋接療法時，這是一個非常可以接受的，我什至不能說是可以接受的，我會說是舒適的狀態。無論是後期還是早期，我們確實已經到了 30 天的標記。因此，與醫生目前所需的時間相比，週轉時間相當具有競爭力，但我們確實希望隨著時間的推移，我們能夠繼續縮短週轉時間。

Yeah. I mean, you heard from Alan how much improvement we have seen in our manufacturing process. In fact, the latest data from Rason suggests that the median efficiency delivery time is about 27 days now.

是的。我的意思是，您從艾倫那裡聽說了我們的製造流程取得了多大的進步。事實上，Rason 的最新數據表明，目前的平均效率交付時間約為 27 天。

And then Chloe, I want to answer a question about the publication. So it's a paper published actually from Cardinal Health with collaboration with the Vanderbilt University Medical Center, and it was based on the response from 50 hematologists and the oncologists. In terms of the breakdown of the survey physicians, it's about 86% in the community practice and then 14% in the academic setting.

然後，克洛伊，我想回答一個關於出版物的問題。這是一篇由 Cardinal Health 與范德比爾特大學醫學中心合作發表的論文，基於 50 名血液學家和腫瘤學家的回饋。從受訪醫師的分佈來看，約有 86% 的醫生從事社區醫療，14% 的醫生從事學術醫療。

It's also very well distributed in terms of geographic distribution of these doctors. So it's 28% from the South, 28% from the Western area, 24% Midwest, 20% Northeast. So if you want to know more about this paper on the survey of 50 physicians on CAR 4 data, we're happy to send you the paper, but it's a very well representative sample set here.

從這些醫生的地理分佈來看，分佈也非常均勻。因此，28% 來自南部，28% 來自西部地區，24% 來自中西部，20% 來自東北部。因此，如果您想了解有關這篇關於 50 名醫生使用 CAR 4 數據進行調查的論文的更多信息，我們很樂意將其發送給您，但這是一個非常有代表性的樣本集。

Okay. Thanks, Ying. I'm wondering if you could maybe comment on what feedback you got from them on what, well, I guess, what are you hearing and what is needed to further improve kind of their approval ratings in the second line prescriber setting.

好的。謝謝，英。我想知道您是否可以評論一下您從他們那裡得到的反饋，嗯，我猜，您聽到了什麼，以及需要做什麼來進一步提高他們在第二線處方環境中的支持率。

So what we're hearing anecdotally from the field is that obviously, the community-based hematologists and oncologists are really excited about survival. When we surveyed them on the three most important decision factors when they choose a medicine for Second Life, they ranked in such an order, right, survival followed by TFS and then followed by a response rate including complete response rate. So that shows you there's a divergence here because in the academic setting, the physicians in (inaudible) also tend to put TFS on par with OS, but in the community setting, clearly, there's a very strong preference on survival here. That's what we're finding out in the community setting.

因此，我們從現場聽到的傳聞是，顯然，社區的血液學家和腫瘤學家對生存感到非常興奮。當我們調查他們在為 Second Life 選擇藥物時最重要的三個決策因素時，他們按這樣的順序排列，對吧，生存率，其次是 TFS，然後是反應率，包括完全反應率。這表明這裡存在分歧，因為在學術環境中，（聽不清楚）的醫生也傾向於將 TFS 與 OS 相提並論，但在社區環境中，顯然，他們更傾向於生存。這就是我們在社區環境中發現的。

And like I said, we fully expect the FDA to approve our survival data in the label in the fall this year, we have a date here. And you know, this survival benefit will also be augmented by our ASCO presentation in the next month. So you will see that once we have the detailed data and the physicians, I'm sure will be excited about by the long-term follow up data in terms of the long-term remission.

正如我所說的，我們完全希望 FDA 在今年秋季批准標籤中的生存數據，我們這裡已經有一個日期了。您知道，我們下個月在 ASCO 上展示的內容也將增強這種生存優勢。因此，您會看到，一旦我們獲得了詳細的數據，我相信醫生們會對長期緩解的長期追蹤數據感到興奮。

Sean McCutcheon, Raymond James.

肖恩麥卡琴、雷蒙德詹姆斯。

Hi guys, thanks for squeezing me in. Can you speak to the bar to take the CLAUDIN 18.2 program forward? We've seen some decent results from (inaudible) with some entrying frontline signals in sequence with chemo, and but the durability for the second line setting looks like it could be more of a question. And maybe it's restricted to the CLAUDIN 1.2 high expressers. And secondarily, should we expect a similar approach on the development compared to the DLL3 program, meaning would you want to take it forward with a partner? Thanks.

大家好，感謝你們邀請我加入。您能和酒吧談談如何推進 CLAUDIN 18.2 計畫嗎？我們已經看到了一些不錯的結果，（聽不清楚）一些進入前線訊號與化療順序，但第二線設定的耐久性似乎是一個問題。也許它僅限於 CLAUDIN 1.2 高表達者。其次，我們是否應該期待與 DLL3 程式類似的開發方法，這意味著您是否希望與合作夥伴一起推廣它？謝謝。

Thank you for your question. So regarding the CLAUDIN 18.2 study, we are, as discussed earlier, going to be presenting some data at ASCO. We anticipate the dose escalation to be complete later at the end of summer, and then we anticipate the expansions to begin in at that time. We have -- obviously, CLAUDIN 18.2 is important both in gastric cancer but also pancreatic cancer. I think it's also while there is an antibody approved Zotuximab in the frontline setting in gastric cancer, the expression, the CLAUDIN expression is quite high in order for people to use that antibody.

感謝您的提問。關於 CLAUDIN 18.2 研究，正如先前所討論的，我們將在 ASCO 上展示一些資料。我們預計劑量增加將在夏末晚些時候完成，然後我們預計擴展將在那時開始。顯然，CLAUDIN 18.2 對胃癌和胰臟癌都很重要。我認為，雖然有一種抗體 Zotuximab 已被批准用於治療胃癌的第一線治療，但 CLAUDIN 的表達相當高，人們才可以使用這種抗體。

I think in general, we've seen that CAR-T cells tend to have more sensitivity for lower expressing cells, so there's, I think, an opportunity to pursue CAR-T in this space, both in gastric cancer and pancreatic cancer. So we'll have to wait and see how the completion of the safety dose escalation is, but we are excited for the opportunity to explore this further in the expansion.

我認為總的來說，我們已經看到 CAR-T 細胞對低表達細胞具有更高的敏感性，因此我認為在這個領域有機會探索 CAR-T，無論是在胃癌還是胰腺癌中。因此，我們必須拭目以待，看看安全劑量升級的完成情況，但我們很高興有機會在擴展中進一步探索這一點。

Thank you. This concludes the question-and-answer session. Thank you for your participation in today's conference. This has conclude the program, you may now disconnect.

謝謝。問答環節到此結束。感謝大家參加今天的會議。程式已結束，您現在可以斷開連線。