Legend Biotech Corporation (LEGN) 2026 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Legend Biotech first quarter 2026 earnings conference call. (Operator Instructions) Today's conference is being recorded. I will now hand the conference over to your speaker host for today, Jessie Yeung, Vice President of Investor Relations and Finance. Please go ahead.

各位好，感謝您稍候。歡迎參加 Legend Biotech 2026 年第一季財報電話會議。(接線員指示) 今天的會議將被錄音。現在我將把會議交給今天的主持人——投資人關係與財務副總裁 Jessie Yeung。請開始。

Good morning. This is Jessie Yeung, Vice President of Investor Relations and Finance at Legend Biotech. Thank you for joining our conference call today to review our first quarter of 2026 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.

各位早安。我是 Legend Biotech 投資人關係與財務副總裁 Jessie Yeung。感謝各位參加今天的電話會議，一同回顧我們 2026 年第一季的表現。在本次電話會議之前，我們已發布新聞稿，公告本季財務結果。您可於 legendbiotech.com 的投資人關係網站找到該新聞稿。

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

今天與我一同參與電話會議的有：公司執行長 Ying Huang；CARVYKTI 總裁 Alan Bash；以及公司財務長 Carlos Santos。在事先準備的發言之後，我們將開放問答環節。我們的研發總裁 Guowei Fang 也將參與問答環節。

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 herein. 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，我們將發表前瞻性陳述；此類陳述受風險與不確定性影響，可能導致實際結果與本文明示或暗示者存在重大差異。這些前瞻性陳述在我們向 SEC 提交的文件中有更詳細的討論；我們鼓勵您閱讀，並可於公司網站「投資人」專區查閱。

In addition, adjusted net loss is a non-IFRS metrics. 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 this 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 understanding of our financial performance.

此外，調整後淨虧損為非 IFRS 指標。此非 IFRS 財務衡量指標是對依 IFRS 編製之財務績效衡量指標的補充，並非替代，亦不優於後者。相較於其最接近的 IFRS 對應指標，使用此非 IFRS 財務衡量指標存在若干限制。然而，我們相信提供調整後淨虧損及每股調整後淨虧損資訊，有助於投資人更理解我們的財務表現。

We use adjusted net loss as a performance metric that guides management in its operation of and planning for the future of the business. In particularly, we exclude unrealized gain or loss from foreign exchange rate changes. We believe that adjusted net income or loss provide a useful measure of our operating performance from period to period. Our press release includes IFRS to non-IFRS reconciliations for these measures.

我們使用調整後淨虧損作為績效指標，以指引管理層在營運及未來業務規劃上的決策。特別是，我們排除外匯匯率變動所產生的未實現損益。我們相信調整後淨利或淨損可作為衡量我們各期間營運表現的有用指標。我們的新聞稿包含這些指標由 IFRS 轉換至非 IFRS 的調節表。

With that, I will now turn the call over to Ying.

接下來，我將把電話會議交給 Ying。

Hello, everyone. Thank you for joining us today. We began 2026 with strong momentum as we executed commercially and continued to advance our pipeline. Legend is the largest standalone cell therapy company anchored by CARVYKTI, our market-leading and profitable CAR-T therapy for multiple myeloma. In parallel, we're working to advance CARVYKTI into the first-line treatment setting to help reach more patients and further broaden its long-term opportunity.

各位好。感謝各位今天加入我們。我們以強勁動能展開 2026 年，在商業執行上持續推進，並持續推動產品線進展。Legend 是最大的獨立細胞治療公司，以 CARVYKTI 為核心——這是我們在多發性骨髓瘤領域市佔領先且已實現獲利的 CAR-T 療法。同時，我們正推動 CARVYKTI 進入一線治療情境，以幫助觸及更多病患，並進一步擴大其長期機會。

Beyond CARVYKTI, we also have a strong pipeline of potentially transformative cell therapies across additional therapeutic areas where curative options remain limited. As this pipeline matures and it generates more meaningful clinical data, we're looking forward to presenting some of this data at upcoming medical conferences this year.

除 CARVYKTI 之外，我們在其他治療領域亦擁有強勁的產品線，涵蓋多項可能帶來變革的細胞療法；在這些領域中，具治癒性的選項仍然有限。隨著產品線逐步成熟並產出更具意義的臨床數據，我們期待在今年即將舉行的醫學會議上發表其中部分數據。

During the first quarter of 2026, CARVYKTI net trade sales were approximately USD597 million, representing 62% growth compared to the first quarter of 2025. This was comprised of 36% growth in the US year-over-year and more than 200% growth from ex-US sales. This performance reflects strong demand in earlier-line settings, continued global expansion, and consistently best-in-class manufacturing execution.

在 2026 年第一季，CARVYKTI 淨貿易銷售額約為 5.97 億美元，較 2025 年第一季成長 62%。其中，美國市場年增 36%，美國以外市場銷售成長超過 200%。此表現反映出在較早線別治療中的強勁需求、持續的全球擴張，以及一貫同級最佳的製造執行力。

Importantly, the myeloma treatment paradigm continues to shift toward earlier use of CAR-T. In a recent social media poll for KOLs conducted by Dr. Ben Derman from University of Chicago, 66% of respondents indicated they would recommend CAR-T at first relapse for contemporary myeloma patient followed by DVRd induction and maintenance, assuming daratumumab resistance. We view this sentiment as further validation that CARVYKTI is increasingly considered a foundational therapy earlier in the disease course.

重要的是，骨髓瘤治療典範持續朝向更早使用 CAR-T 轉變。在芝加哥大學的 Ben Derman 醫師近期針對 KOL 於社群媒體所做的投票中，66% 的受訪者表示，若假設對 daratumumab 產生抗藥性，對於接受 DVRd 誘導與維持治療的當代骨髓瘤病患，他們會建議在首次復發時使用 CAR-T。我們認為這樣的觀點進一步驗證：CARVYKTI 正日益被視為在疾病較早期即應採用的基礎性治療。

Before transitioning to the pipeline, I want to highlight an important step we announced earlier this month. We recently engaged 6 distinguished scientific advisors, Renier Brentjens, Spencer Fisk, Carl June, Maximilian Konig, Tony Polverino, and Georg Schett, who bring deep expertise across oncology, immunology, and in particular, cell therapy, as well as translational research. As we broaden our pipeline, we believe their input and advice will help guide critical scientific and clinical decisions and strengthen the rigor behind our long-term R&D strategy.

在轉入產品線更新之前，我想強調我們本月稍早宣布的一項重要進展。我們近期延攬 6 位傑出的科學顧問：Renier Brentjens、Spencer Fisk、Carl June、Maximilian Konig、Tony Polverino 與 Georg Schett；他們在腫瘤學、免疫學，尤其是細胞治療，以及轉譯研究方面具備深厚專長。隨著我們擴展產品線，我們相信他們的意見與建議將有助於引導關鍵的科學與臨床決策，並強化我們長期研發策略背後的嚴謹性。

At the top of pipeline, we have some of the larger active CARVYKTI trials. Most importantly, CARTITUDE-5 and CARTITUDE-6 are pivotal Phase III studies designed to assess CARVYKTI in frontline multiple myeloma following its label expansion in earlier lines. Turning to our earlier stage pipeline, you're going to start to hear more about these programs as the clinical data starts to mature from our next-generation cell therapy platforms.

在產品線最前端，我們有數項規模較大的 CARVYKTI 進行中試驗。其中最重要的是 CARTITUDE-5 與 CARTITUDE-6，這兩項為關鍵性第三期研究，旨在於 CARVYKTI 擴大適應症至較早線別後，評估其在一線多發性骨髓瘤治療中的表現。接著談到我們較早期的產品線：隨著我們次世代細胞治療平台的臨床數據逐步成熟，您將開始聽到更多關於這些計畫的消息。

Our BCMA in vivo program in autoimmune diseases has entered Phase I. Beyond BCMA, our GPRC5D in vivo program in multiple myeloma has also entered Phase I. In parallel, our other in vivo CAR-T programs continue to progress, and we remain on track to report initial data this year in non-Hodgkin's lymphoma. We continue to expect to file one to two US INDs in 2026 and are excited by the differentiated potential of our approach.

我們針對自體免疫疾病的 BCMA 體內（in vivo）計畫已進入第一期。除 BCMA 外，我們針對多發性骨髓瘤的 GPRC5D 體內（in vivo）計畫也已進入第一期。同時，我們其他體內 CAR-T 計畫持續推進，並仍按計畫於今年在非霍奇金淋巴瘤公布初步數據。我們仍預期在 2026 年提交 1 至 2 件美國 IND 申請，並對我們方法的差異化潛力感到振奮。

Financially, our strong balance sheet provides us with flexibility to invest in our priorities while maintaining a clear focus on profitability. We believe this combination of commercial leadership, pipeline innovation, and financial discipline positions Legend well to deliver durable value for patients and shareholders over the long term.

在財務方面，我們強健的資產負債表使我們能在維持對獲利能力清晰聚焦的同時，保有投資於優先事項的彈性。我們相信，商業領導地位、產品線創新與財務紀律的結合，使 Legend 具備良好定位，能在長期為病患與股東創造可持續的價值。

With that, I will turn the call over to Alan.

接下來，我將把電話會議交給 Alan。

Thank you, Ying. I'll start with a high-level view of CARVYKTI's commercial performance and then spend time on what's driving growth beneath the surface. In Q1, CARVYKTI delivered another quarter of sequential growth, reflecting continued share gains, strong site productivity, and increasing penetration in earlier lines of therapy. Demand remained healthy across all major geographies, supported by our expanding global footprint and consistently reliable manufacturing execution.

謝謝你，Ying。我將先從 CARVYKTI 商業表現的高層次概覽開始，接著再談推動成長的深層因素。在第一季，CARVYKTI 再次實現連續季度成長，反映出市佔持續提升、據點生產力強勁，以及在較早線別治療中的滲透率提高。在我們不斷擴大的全球布局與一貫可靠的製造執行力支持下，各主要地區的需求仍維持健康。

CARVYKTI net trade sales in the first quarter were approximately USD597 million, representing 8% sequential growth from Q4 2025. In the US, growth was driven primarily by increased utilization in earlier-line settings, continued activation of new authorized treatment centers, and steady throughput at existing sites.

CARVYKTI 第一季淨貿易銷售額約為 5.97 億美元，較 2025 年第四季季增 8%。在美國，成長主要由於在較早線治療情境中的使用率提升、持續啟用新的授權治療中心，以及既有站點的穩定處理量所帶動。

Outside the US, demand was supported by continued uptake in established European markets and contributions from recent launches, with CARVYKTI now available across 18 global markets and more than 300 global treatment sites. As expected, international growth continues to scale as site experience, manufacturing slots, and referral patterns mature.

在美國以外，需求受到已建立的歐洲市場持續採用以及近期上市貢獻的支持；目前 CARVYKTI 已在全球 18 個市場上市，並覆蓋超過 300 個全球治療站點。如預期，隨著站點經驗、製造產能時段（manufacturing slots）與轉介模式逐步成熟，國際成長仍在持續擴大。

Turning to the next slide, we want to highlight how we are accelerating growth through our manufacturing optimization and earlier-line momentum. From a manufacturing standpoint, we continue to optimize. This past quarter, we achieved a 99% manufacturing success rate and a median turnaround time of approximately 29 days with delivering more than 95% on-time order releases for final product delivery. We believe these metrics are a testament to our commitment to broadening adoption, particularly as physicians move CAR-T earlier in the treatment paradigm.

接著看下一張投影片，我們想強調我們如何透過製造優化與較早線動能來加速成長。就製造面而言，我們持續進行優化。在本季，我們達成 99% 的製造成功率，中位數周轉時間約 29 天，且最終產品交付方面超過 95% 的訂單能準時放行。我們相信，這些指標證明了我們致力於擴大採用的承諾，特別是在醫師將 CAR-T 更早導入治療流程之際。

Importantly, although we do not intend to break this out every quarter since we think about our business on a longer-term basis, we wanted to provide a glimpse of the traction made in earlier-line settings in the US, where nearly 80% of patients are treated in the community setting. As you can see on the far right-hand part of the slide in the color teal, patients in second line and third line represented 41% of CARVYKTI apheresis volume in the US in the first quarter of 2026, compared to 29% in the same period a year ago.

重要的是，雖然我們不打算每一季都拆分揭露，因為我們以更長期的角度看待業務，但我們想提供一個美國較早線治療情境的進展縮影；在美國，近 80% 的患者是在社區醫療場域接受治療。如投影片最右側的藍綠色所示，2026 年第一季在美國，第二線與第三線患者占 CARVYKTI 單採（apheresis）量的 41%，而一年前同期為 29%。

This trend reflects growing physician confidence in CARVYKTI's benefit risk profile earlier in the disease course and our ability to reliably support that shift at scale. We expect this trend to continue and be a major driver of future growth, especially as we advance towards a potential label expansion into the first line setting.

此趨勢反映醫師對 CARVYKTI 在疾病較早期之效益/風險概況的信心提升，以及我們具備在規模化情況下可靠支援此轉變的能力。我們預期此趨勢將持續，並成為未來成長的主要驅動力，尤其是在我們朝向可能擴大適應症標籤至第一線治療邁進之際。

With that, I will turn the call over to Carlos to walk through our financial performance.

接下來，我將把電話會議交給 Carlos，請他帶大家回顧我們的財務表現。

Thank you, Alan, and good morning, everyone. I'm pleased to walk you through our financial performance, which reflects an important quarter of commercial growth and disciplined investment. Turning to the next slide, this chart highlights our progress towards profitability.

謝謝你，Alan，各位早安。我很高興帶大家回顧我們的財務表現，這反映了一個商業成長重要的季度，以及有紀律的投資。接著看下一張投影片，這張圖表凸顯我們朝向獲利的進展。

As you can see, revenue has continued to scale, driven by CARVYKTI performance, and profitability metrics have improved steadily over time. We anticipate company-wide profitability on an adjusted basis in 2026 and expect continued margin improvements from our ongoing expense discipline.

如各位所見，營收持續擴大，主要由 CARVYKTI 的表現所帶動，而獲利相關指標也隨時間穩步改善。我們預期公司在 2026 年以調整後基礎達成整體獲利，並預期在持續費用紀律下，毛利率/利潤率將持續改善。

Regarding Q1, the next slide illustrates how revenue growth is translating into operating leverage. Collaboration revenue was approximately USD298 million in the first quarter, primarily driven by CARVYKTI net trade sales under our collaboration with Johnson & Johnson. License and other revenue was approximately USD7 million, resulting in total revenue of USD305 million for the quarter.

就第一季而言，下一張投影片說明營收成長如何轉化為營運槓桿。第一季合作收入約為 2.98 億美元，主要來自我們與嬌生（Johnson & Johnson）合作下的 CARVYKTI 淨貿易銷售額。授權及其他收入約為 700 萬美元，使本季總營收達 3.05 億美元。

Gross margin on net product sales was 41%. The decline from the fourth quarter at 57% was primarily due to one-time expenses associated with ramping up manufacturing in the newly expanded section of our Raritan site and the ongoing Tech Lane facility ramp. Looking ahead to the second quarter, we expect gross margin to be back over 50% as the economies of scale from our manufacturing investment are realized with increasing utilization.

淨產品銷售的毛利率為 41%。相較第四季的 57% 下滑，主要是因為一次性費用，與我們在 Raritan 廠區新擴建區域的製造爬坡，以及 Tech Lane 設施持續爬坡相關。展望第二季，隨著製造投資在使用率提升下帶來規模經濟，我們預期毛利率將回升至 50% 以上。

Research and development expense was USD86 million, reflecting continued investment in our in vivo CAR-T platform and next-generation programs. As the Phase III CARTITUDE-5 and CARTITUDE-6 studies for CARVYKTI mature, we expect a substantial decline in the associated R&D expenses. This allows an increasing proportion of the R&D budget to be reinvested into the pipeline as we leverage the benefit of CARVYKTI profitability to fund the future growth of Legend that will come from the promising in vivo programs and extensive earlier stage pipeline that Ying showed earlier.

研發費用為 8,600 萬美元，反映我們持續投資於體內（in vivo）CAR-T 平台與次世代計畫。隨著 CARVYKTI 的第三期 CARTITUDE-5 與 CARTITUDE-6 研究逐步成熟，我們預期相關研發費用將大幅下降。這使得研發預算中更高比例可再投入到產品線（pipeline），因為我們將運用 CARVYKTI 獲利能力的效益，為 Legend 未來成長提供資金；該成長將來自具前景的體內（in vivo）計畫，以及 Ying 先前展示的廣泛早期產品線。

SG&A expense was USD90 million, driven by targeted commercial investments supporting CARVYKTI growth. Operating loss narrowed compared to the prior year, with an adjusted net loss of USD11 million in Q1. We feel very comfortable in maintaining our projection for achieving company-wide profitability on an adjusted basis in 2026. On a non-IFRS basis, this represents USD0.03 per diluted share, compared with an adjusted net loss of USD27 million or USD0.07 per diluted share in the same period last year.

銷售、一般及行政（SG&A）費用為 9,000 萬美元，主要由支持 CARVYKTI 成長的精準商業投資所驅動。相較前一年，營業虧損收窄，第一季調整後淨虧損為 1,100 萬美元。我們對於維持 2026 年以調整後基礎達成公司整體獲利的預測感到非常有信心。以非 IFRS 基礎計算，這相當於每股稀釋後虧損 0.03 美元；而去年同期調整後淨虧損為 2,700 萬美元或每股稀釋後虧損 0.07 美元。

Turning to the next slide, we ended the quarter with approximately USD835 million in cash, cash equivalents, and time deposits, and no long-term debt. We believe this strong balance sheet provides us with flexibility to advance our in vivo CAR-T pipeline, support continued CARVYKTI profitability expansion, pursue focused business development opportunities, and fund modest capital expenditures tied to manufacturing capacity. Based on our recent progress, we remain confident in our company-wide profitability trajectory as we continue to invest prudently in long-term growth. In summary, the first quarter reflects a business that is scaling efficiently, generating increasing operating leverage, and approaching sustained profitability.

接著看下一張投影片，本季末我們持有約 8.35 億美元的現金、約當現金與定期存款，且沒有長期負債。我們相信，這份強健的資產負債表為我們提供彈性，以推進體內（in vivo）CAR-T 產品線、支持 CARVYKTI 獲利擴張的持續進展、尋求聚焦的業務開發機會，並為與製造產能相關的適度資本支出提供資金。基於近期進展，我們在持續審慎投資長期成長的同時，仍對公司整體獲利軌跡保持信心。總結而言，第一季反映出我們的業務正有效率地擴張，產生愈來愈高的營運槓桿，並接近可持續的獲利。

With that, we're happy to take your questions.

接下來，我們很樂意回答各位的問題。

Terence Flynn, Morgan Stanley.

Morgan Stanley 的 Terence Flynn。

Thanks so much for taking the question. Obviously, there's a growing focus on in vivo programs, platforms. Maybe, Ying, you could give us a little bit of update in terms of how much data we should expect from your lymphoma program and any more specifics on timing. Is EHA a possibility, or is it more likely ASH? How are you thinking about durability, and what will we learn from this first data set with respect to that question? Thank you.

非常感謝讓我提問。顯然，市場對體內（in vivo）計畫與平台的關注正在升溫。Ying，也許你可以就淋巴瘤計畫預期會有多少數據，以及更具體的時間點，給我們一些更新。EHA 是否有可能，還是更可能在 ASH？你們如何看待持久性（durability），而我們能從第一批數據集中學到什麼來回答這個問題？謝謝。

Morning, Terence. Thank you for that question. As typical with our disclosure practice, we cannot really comment on the data without the abstract being officially accepted and also published by the major medical meeting. The only thing I can confirm is that we are planning to potentially present this data set for the first time in patient with non-Hodgkin lymphoma at a major medical meeting around mid-year. That's the only thing I can confirm right now.

早安，Terence。謝謝你的提問。依照我們一貫的資訊揭露做法，在摘要（abstract）尚未被正式接受並由主要醫學會議發表之前，我們無法對數據做出評論。我唯一能確認的是，我們計畫在年中左右的一個主要醫學會議上，可能首次發表這一組非霍奇金淋巴瘤患者的數據。目前我只能確認到這些。

In terms of durability, I guess it's really depending on how many patients and how much follow-up we have. In general, because this is the first disclosure for our clinical data here, I wouldn't expect a very, very long follow-up. We do expect a reasonable number of patients in this first disclosure. I hope that answers your question, Terence.

就持久性而言，我想這確實取決於我們有多少位病人以及有多少隨訪。一般來說，因為這是我們在此首次披露臨床數據，我不會預期會有非常、非常長的隨訪時間。我們確實預期在這次首次披露中會有相當數量的病人。希望這回答了你的問題，Terence。

Umer Raffat, Evercore ISI.

Umer Raffat，Evercore ISI。

Thanks for taking my question. I have -- I wanted to touch up on this in vivo CAR-T theme in a little more detail, perhaps. Maybe for everyone listening in, Ying, because this is a new theme popping up beyond CARVYKTI, beyond Arcellx, could you just remind everyone, first of all, that the CD19, CD20 CAR-T you have is not the gamma delta, which is allo. We're talking about in vivo, A, if you could just clarify that. B, the name of the program, like the number. Number 3, I acknowledge you can't say if it'll be at EHA or not and the scope of the data, but could you just give us a sense for what the trial design is that's being run? And should we expect efficacy data as well, or should the data disclosure only be limited to whether you dosed it and they developed CAR-T, and then what the safety looked like? Should there be some early efficacy as well? Thank you.

謝謝讓我提問。我想——我希望能更詳細地談一下這個體內（in vivo）CAR-T 的主題。也許為了讓所有在收聽的人都更清楚，Ying，因為這是一個在 CARVYKTI、在 Arcellx 之外新出現的主題，你能否先提醒大家：首先，你們的 CD19、CD20 CAR-T 並不是 γδ（gamma delta），後者是同種異體（allo）。我們談的是體內（in vivo），A，如果你能澄清一下。B，這個項目的名稱，比如編號。第三點，我理解你不能說是否會在 EHA 上披露以及數據範圍，但你能否讓我們了解一下目前正在進行的試驗設計是什麼？我們是否也應該期待有效性數據，還是披露僅限於是否完成給藥、是否產生了 CAR-T，以及安全性表現如何？是否也會有一些早期有效性？謝謝。

Umer, thanks for your question. I will answer the first two parts, then I'll ask my colleague, Guowei, President of R&D, to answer the third question regarding the design and everything else.

Umer，謝謝你的問題。我會先回答前兩部分，然後我會請我的同事、研發總裁 Guowei 來回答第三個關於設計及其他事項的問題。

First of all, yes, we can confirm that this is not the gamma delta T program. This is actually in vivo CAR-T targeting CD19 and CD20, using a lentiviral vector delivery. That's first. Secondly, I can confirm that the internal codename we use for this program is LB2501. This program is already up on ClinicalTrials.gov. If you want to search for the details on the protocol and the enrollment.

首先，是的，我們可以確認這不是 γδ T 的項目。這其實是一個以慢病毒載體（lentiviral vector）遞送的體內 CAR-T，靶向 CD19 與 CD20。這是第一點。第二，我可以確認我們對這個項目使用的內部代號是 LB2501。這個項目已經登載在 ClinicalTrials.gov 上。如果你想查詢方案與入組的細節，可以去搜尋。

On the third question, I'll ask Wei to answer.

關於第三個問題，我請 Wei 來回答。

Yes. In terms of clinical data to be released, the trial was initiated last year. We do expect to release both safety and efficacy data. We have to wait and share the data presentation to really disclose specific information. In terms of our internal expectation, our expectation for in vivo program is to have manageable safety and promising efficacy, including deep response. That's our expectation.

好的。就將要發布的臨床數據而言，該試驗於去年啟動。我們確實預期會同時發布安全性與有效性數據。我們需要等到數據發表時，才能真正披露具體資訊。就我們內部的預期而言，我們對體內項目的期望是安全性可控且有效性具前景，包括深度緩解。這就是我們的預期。

Thank you very much.

非常感謝。

Jessica Fye, JPMorgan.

Jessica Fye，摩根大通（JPMorgan）。

Good morning. Thanks for taking my questions. A couple on kind of the existing business. First, appreciate the additional detail on the breakdown of CARVYKTI used across lines of therapy. If we look out another year or two, what do you think that pie chart mix will look like? And then second, just on the higher COGS this quarter, how much of that about USD100 million year-over-year increase was one-time versus sort of ongoing? Thank you.

早安。謝謝讓我提問。有幾個關於現有業務的問題。首先，感謝你們補充了 CARVYKTI 在不同治療線別使用情況的拆分細節。如果我們往後看一到兩年，你認為那個圓餅圖的組合會是什麼樣子？第二，關於本季較高的銷貨成本（COGS），這個約 1 億美元的同比增幅中，有多少是一次性的、多少是偏持續性的？謝謝。

Hi, it's Alan. Thanks for the question. In terms of our business mix, we're very pleased to show the data that reflects the fact that in earlier lines, specifically in second and third line, we have about 41% of our patients coming through those lines. I think that's important for a couple of reasons.

嗨，我是 Alan。謝謝你的問題。就我們的業務組合而言，我們很高興展示的數據反映出：在較早治療線別，特別是第二線與第三線，大約有 41% 的病人來自這些線別。我認為這有幾個重要原因。

One is it does speak to the fact that we're getting community adoption because those earlier patients start in the community and are getting referred into the authorized treatment centers. It also speaks to the fact that our clinical data is resonating with the earlier is better data both for efficacy, safety, and manufacturing, all based on the data that we shared at ASH and previous conferences that earlier is better. I think it also sets us up well from a competitive standpoint to make sure we are penetrating the second- and third-line businesses in the face of whether it's bispecifics or potential future BCMA CAR-T competition.

其一，這確實說明我們正在獲得社區端的採用，因為那些較早線別的病人通常從社區端開始，之後被轉診到授權治療中心。這也說明我們的臨床數據正在呼應「越早越好」的結論——無論是有效性、安全性還是製造端——這些都基於我們在 ASH 以及先前會議上分享的數據，即越早越好。我認為這也讓我們在競爭層面上處於有利位置，確保在面對雙特異性抗體或未來潛在的 BCMA CAR-T 競爭時，我們能夠滲透第二線與第三線市場。

To answer your question, we've also shown progression in the overall second through fourth line at about 2/3 of our business, and we do expect that that will continue to grow, probably to about 3/4 of our business is where we would anticipate that emerging over the next year or so. All segments continue to grow, and we're very excited by the penetration in the earlier lines.

回答你的問題，我們也顯示出整體第二線到第四線約占我們業務的三分之二，而且我們預期這一比例會持續成長，可能在未來一年左右提升到約四分之三，這是我們預估的走勢。各個細分市場都在持續成長，我們對於在較早線別的滲透感到非常振奮。

Related to the gross margin question, we did see a sequential decline in the first quarter since we brought new capacity into our network, specifically to our Raritan site. This, together with one-time expenses associated with the expansion, resulted in this one-time impact to gross margin. However, we do expect that gross margins will return to over 50% in Q2.

關於毛利率的問題，由於我們將新增產能導入我們的網絡，特別是導入到 Raritan 廠區，因此第一季毛利率確實出現了環比下滑。這一點再加上與擴產相關的一次性費用，導致毛利率出現這次一次性的影響。不過，我們確實預期第二季毛利率會回到 50% 以上。

Can you quantify the one-time impact a little more?

你能否再多量化一點這個一次性影響？

We do not disclose those particulars.

我們不披露這些具體細節。

Thank you.

謝謝。

Jess, this is Ying. I just want to add that you heard from Carlos that we fully expect the gross margin to recover to prior level in the second and also the ensuing quarters for the year.

Jess，我是 Ying。我只是想補充，你也聽到 Carlos 說，我們完全預期毛利率會在第二季以及今年後續各季恢復到先前水準。

Thanks.

謝謝。

Kostas Biliouris, Oppenheimer.

Kostas Biliouris，Oppenheimer。

Thanks for taking our question. Congrats on the progress. Maybe a couple of quick questions from us. One on the commercial side, do you see any meaningful impact after TECVAYLI approval in the second line now, perhaps on any particular segments of patients or any particular geographies?

謝謝讓我們提問。恭喜取得進展。我們這邊可能有兩個簡短問題。第一個在商業端：TECVAYLI 現在獲批用於第二線之後，你們是否看到任何顯著影響——例如對某些特定病人族群或特定地區？

The second one on the in vivo CAR-T, can you help us understand what the benchmarking is there? Some investors are trying to compare your upcoming data to other ex vivo CAR-T therapies in NHL. Some other investors are looking to benchmark it to in vivo CAR-T from multiple myeloma. Any thoughts on where the benchmarking is in your view would be helpful. Thank you.

第二個關於體內 CAR-T：你能否幫我們理解你們的對標（benchmarking）基準是什麼？有些投資人試圖把你們即將公布的數據與 NHL 的其他體外（ex vivo）CAR-T 療法做比較。也有一些投資人想把它與多發性骨髓瘤的體內 CAR-T 做對標。你們認為應該如何對標的任何看法都會很有幫助。謝謝。

Our business continues to grow, as you saw from our report today, it continues to grow, particularly in the earlier lines. In terms of competition from TECVAYLI or the presence of bispecifics, I'll remind you that this is a large market in second through fourth line, about 100,000 patients. Only about 5% have seen a BCMA, there's significant growth potential for multiple options in the earlier lines. I think that's also reflected by the IQVIA data that you see.

我們的業務持續成長，正如你今天從我們的報告中所看到的，持續成長，尤其是在較前線的治療線別。就來自 TECVAYLI 的競爭或雙特異性抗體的存在而言，我提醒你，這在第二線到第四線是一個很大的市場，約有 10 萬名患者。只有約 5% 曾接受過 BCMA 治療，在較前線仍有多種選項的顯著成長潛力。我認為這也反映在你所看到的 IQVIA 數據中。

While other products are growing, CARVYKTI has also shown healthy growth as well. Through potential competition with bispecifics, I think this is a large market that's severely underserved and under-penetrated, that portends well for the opportunity for CARVYKTI.

在其他產品成長的同時，CARVYKTI 也展現了健康的成長。面對雙特異性抗體的潛在競爭，我認為這是一個嚴重服務不足、滲透率偏低的大市場，這預示著 CARVYKTI 的機會前景良好。

For the second question, in term of a benchmark for in vivo CAR-T program, our lead program is CD19, CD20 dual targeting in vivo CAR-T program targeted for non-Hodgkin's lymphoma patient. Our current thinking is that we are expecting or we are looking for deep and durable response, and therefore, the benchmark would expected to align with that type of efficacy response. Currently that's still early, and we are accumulating more data.

關於第二個問題，就體內（in vivo）CAR-T 計畫的標竿而言，我們的領先計畫是 CD19、CD20 雙靶向的體內 CAR-T 計畫，目標族群為非霍奇金氏淋巴瘤患者。我們目前的想法是，我們期望或正在尋求深度且持久的反應，因此標竿預期會與那類療效反應一致。目前仍屬早期，我們正在累積更多數據。

If I can add a follow-up here. If you see these type of responses in NHL, deep responses as you call it, would that translate to multiple myeloma to some extent as well for the in vivo CAR-T platform? Thank you.

如果我可以在這裡追問一下。如果你在 NHL 看到這類反應，也就是你所說的深度反應，這是否也能在某種程度上轉譯到多發性骨髓瘤，用於體內 CAR-T 平台？謝謝。

Excellent question. We do think that in vivo CAR-T platform has the transformative potential by moving all the cell engineering and the cell expansion into the body of patients, therefore generate a better cell fitness. Therefore, that could translate into even better clinical response. That's our expectation across different disease areas. Thank you.

很好的問題。我們確實認為體內 CAR-T 平台具有變革性的潛力，因為它把所有細胞工程與細胞擴增移到患者體內進行，從而產生更佳的細胞適能。因此，這可能轉化為更好的臨床反應。這是我們對不同疾病領域的共同預期。謝謝。

Etzer Darout, Barclays.

Etzer Darout，巴克萊。

Thanks for taking the question. Congrats on the quarter. A couple of questions, maybe on the CARVYKTI side, if you could maybe provide any updates, new updates on the timing for CARVYKTI 5 or 6. And then on the pipeline, just wondered if you could maybe talk about the scope of the BCMA trial that you're initiating with the in vivo CAR-T, I think LB2505. Maybe if you can comment on the scope and the trial design there. Thank you.

謝謝讓我提問。恭喜本季表現。有幾個問題，可能先從 CARVYKTI 這邊，如果可以的話，能否提供 CARVYKTI 5 或 6 的時程方面是否有任何更新或新的進展。另外在研發管線方面，我想請教你們正在啟動的、以體內 CAR-T 進行的 BCMA 試驗（我想是 LB2505）的規模。如果可以的話，請評論一下其範圍與試驗設計。謝謝。

CARTITUDE-5 and CARTITUDE-6 are fully enrolled, but these are event driven, so we don't have an update here on the timing, and we'll continue to monitor in terms of how the events accrue.

CARTITUDE-5 與 CARTITUDE-6 都已完成收案，但這些是事件驅動（event-driven）的，因此我們目前沒有時程更新；我們會持續監測事件累積的情況。

For the in vivo CAR-T program, we are excited about our platform and product. We are exploring this product platform across different diseases. Multiple myeloma is important disease area. BCMA certainly is a top target within the multiple myeloma disease space. Our partnership with Johnson & Johnson cover all and any BCMA-directed cell therapy in multiple myeloma that both company are working on. Therefore, at this point, there's nothing more we can share.

就體內 CAR-T 計畫而言，我們對我們的平台與產品感到振奮。我們正在不同疾病中探索這個產品平台。多發性骨髓瘤是一個重要的疾病領域。BCMA 當然是多發性骨髓瘤領域中的首要靶點之一。我們與嬌生（Johnson & Johnson）的合作涵蓋兩家公司在多發性骨髓瘤中所進行的任何及所有以 BCMA 為導向的細胞治療。因此，目前我們沒有更多可以分享的內容。

Etzer, this is Ying. I also want to add that we are initiating another trial for the same construct, LB2505, targeting BCMA, and this will be in autoimmune diseases. You will learn in the near future about that program once we include that in ClinicalTrials.gov.

Etzer，我是 Ying。我也想補充，我們正在為同一個構型（construct）LB2505 啟動另一項試驗，靶向 BCMA，但這將用於自體免疫疾病。一旦我們把該計畫納入 ClinicalTrials.gov，你們在不久的將來就會了解更多。

Great. Thank you.

很好。謝謝。

Eric Schmidt, Cantor Fitzgerald.

Eric Schmidt，Cantor Fitzgerald。

Thanks for taking my question. Maybe just a quick follow-up on the CARTITUDE-5 event rate. I think at one point, we had expected it would be possible to have data toward the end of this year. Is that still the case, Alan?

謝謝讓我提問。想就 CARTITUDE-5 的事件發生率做個快速追問。我記得之前一度預期可能在今年底前取得數據。Alan，現在仍是如此嗎？

Then a financial question on the adjusted net income guidance for profitability in 2026. The adjustments in Q1 are about USD40 million, USD44 million to net income. Is that sort of a non-GAAP adjustment that we'll see on an ongoing basis? I guess I'm looking for some help on the differential between adjusted and GAAP financials. Thank you.

接著是一個財務問題，關於 2026 年達到獲利的調整後淨利指引。第一季的調整項目約為 4,000 萬美元、4,400 萬美元，影響淨利。這是否屬於一種我們會持續看到的非 GAAP 調整？我想請你協助說明調整後與 GAAP 財務數字之間的差異。謝謝。

On CARTITUDE-5, Eric, we would plan to see data at some point in either 2026 or 2027. Again, this is event-driven, so it's really reflective of how the events accrue.

關於 CARTITUDE-5，Eric，我們預計會在 2026 或 2027 年的某個時間點看到數據。同樣地，這是事件驅動的，因此真正取決於事件累積的速度。

On the adjusted net income, as we approach profitability, we wanted to be more specific with our definition. And as we mentioned when we introduced the non-IFRS reconciliation last year, we view adjusted net income as a more accurate reflection of profitability and our financial performance since it excludes certain non-cash items that are not representative of our core business operations. This is aligned with the way most of the industry reports, and it will also allow better comparison both with peers and consistently year-over-year.

關於調整後淨利，隨著我們接近獲利，我們希望更明確地界定其定義。正如我們在去年引入非 IFRS 調節表（reconciliation）時所提到的，我們認為調整後淨利能更準確反映獲利能力與財務表現，因為它排除了某些不代表核心營運的非現金項目。這與多數同業的揭露方式一致，也能讓我們與同業比較以及年對年比較更具一致性。

Okay, I understand why you're doing it. Is the USD44 million differential between the two metrics something that might exist on an ongoing basis?

好的，我理解你們為什麼要這麼做。那麼，兩個指標之間 4,400 萬美元的差距，是否可能會持續存在？

As I mentioned, we do exclude the certain non-cash items, so this would be primarily share-based compensation, depreciation, amortization, and impairments, and foreign exchange.

如我所提到的，我們確實會排除某些非現金項目，因此主要會是以股份為基礎的薪酬、折舊、攤銷與減損，以及外匯。

Thank you.

謝謝。

James Shin, Deutsche Bank.

James Shin，德意志銀行。

Good morning. Thank you for the questions. Circling back to the pipeline, there's three autologous and one in vivo variant for the GPRC5Ds. Are these GPRC5D binders consistent across all the variants, or are the FAST CAR variants using a different manufacturing process and therefore have different binders? Then just following up on the one-time cost of collaboration question, if you exclude this one-time charge, would 1Q '26 been profitable on an adjusted basis? Thank you.

早安。謝謝讓我提問。回到研發管線，有三個自體（autologous）以及一個體內（in vivo）變體用於 GPRC5D。這些變體所使用的 GPRC5D 結合分子（binder）是否一致？還是 FAST CAR 變體使用不同的製造流程，因此有不同的 binder？另外追問一次性合作成本的問題，如果排除這筆一次性費用，2026 年第一季在調整後口徑下是否會是獲利？謝謝。

On the GPRC5D front, all autologous program use the same binder. We are testing the -- have tried to validate the binder as well as try to understand how the patient respond using different design of the CAR-T molecule.

在 GPRC5D 方面，所有自體計畫都使用相同的 binder。我們正在測試——也已嘗試驗證該 binder，同時也試圖了解患者在使用不同 CAR-T 分子設計時的反應情況。

Yes. On the one-time charge, question, the answer is yes. If we wouldn't have had that one-time charge, we would have been profitable on an adjusted income basis.

是的。關於一次性費用的問題，答案是肯定的。如果沒有那筆一次性費用，我們在調整後收益基礎上本來會是獲利的。

Leonid Timashev, RBC Capital Markets.

Leonid Timashev，RBC Capital Markets。

Thanks for taking my question. Wanted to ask on community adoption. I think before you've talked about how you've onboarded Virginia Oncology, Tennessee Oncology. I guess, how's uptake looking in those centers? I guess I'm specifically curious about the actual use of CAR-T in those centers, not necessarily referrals, and sort of what the plan and cadence is of adding additional community centers that can actually administer the CAR-T. Thanks.

謝謝讓我提問。我想問一下社區端的採用情況。我記得你們之前談過已經讓 Virginia Oncology、Tennessee Oncology 上線。那麼這些中心的採用/使用情況如何？我特別想了解的是這些中心實際使用 CAR-T 的情況，不一定是轉介量；以及你們新增更多能夠實際施打 CAR-T 的社區中心的計畫與節奏是什麼。謝謝。

Hey, it's Alan. As we've said before, the community adoption has two components to it, one of which is the one you're speaking to, which is administration in the community among the community networks. We're seeing positive responses from the clinicians in both those sites. You mentioned two of them, we also have the West Cancer Center in Tennessee as well. There are additional sites that are coming online this year.

嗨，我是 Alan。如同我們之前說過的，社區端採用有兩個組成部分，其中之一就是你提到的：在社區端、於社區醫療網絡中進行施打。我們在這兩個據點都看到臨床醫師的正面回饋。你提到其中兩個，我們在田納西州也有 West Cancer Center。今年還會有其他據點陸續上線。

I would say that it's a bit of a longer cycle to make sure that those sites are set up well and have the infrastructure, but we do expect additional sites this year. The experience has been quite positive. Again, speaking to the fact that CAR-T can be administered in the outpatient setting relatively easily, and clinicians are getting more and more comfortable with patient management dynamics.

我會說這是一個相對較長的週期，需要確保這些據點建置完善並具備相關基礎設施，但我們確實預期今年會有更多據點加入。整體經驗相當正面。再次強調，CAR-T 在門診環境中相對容易施打，而臨床醫師也越來越熟悉病患管理的各項動態。

The other part of the community adoption is the referral piece, which you alluded to as well. Again, there we're seeing strong indications that we are getting additional referrals, again, speaking to the fact that our earlier-line business is growing significantly.

社區端採用的另一部分是轉介（referral），你也有提到。同樣地，我們看到強烈跡象顯示轉介量正在增加，這也反映我們較早線治療的業務正在顯著成長。

Then finally, just as a point, we're up to 148 authorized treatment centers in the US. About a third of those are community and regional hospitals, and that's an important component to our mix because that means that we're bringing CARVYKTI closer to patients in those settings as well.

最後補充一點，我們在美國已經有 148 家獲授權的治療中心。其中約三分之一是社區與區域型醫院，這對我們的組合非常重要，因為這代表我們也能在這些場域把 CARVYKTI 帶得更接近病患。

Sean McCutcheon, Raymond James.

Sean McCutcheon，Raymond James。

Thanks for the question. One on CARTITUDE-5 for me. Can you speak to how you're framing, and what you need to show to drive utilization in the frontline transplant-eligible or transplant-not-intended population on a cross-trial basis relative to CEPHEUS, and how you think about the scale and opportunity that could be unlocked by CARTITUDE-5? Thanks.

謝謝讓我提問。我有一個關於 CARTITUDE-5 的問題。你能談談你們如何定位（framing），以及在跨試驗比較、相對於 CEPHEUS 的情況下，你們需要展示什麼才能推動在一線、可移植（transplant-eligible）或不打算移植（transplant-not-intended）族群中的使用量？以及你們如何看待 CARTITUDE-5 可能解鎖的規模與機會？謝謝。

Morning, Sean. This is Ying. If you look at the design for CARTITUDE-5, we are enrolling patients who are not eligible for stem cell transplant or who are eligible, but who choose to defer transplant for various reasons. If you look at comparison arm, it is RVd, it's a three-drug cocktail composing of REVLIMID, Velcade and dexamethasone.

早安，Sean。我是 Ying。如果你看 CARTITUDE-5 的試驗設計，我們納入的是不適合做幹細胞移植的病患，或是符合移植條件但因各種原因選擇延後移植的病患。對照組是 RVd，這是一個三藥組合，由 REVLIMID、Velcade 與 dexamethasone 組成。

Historically, if you look at RVd in the frontline setting in this transplant ineligible population, you have two trials. One is the IFM trials, run by Celgene. The other one is the SWOG S0777 trial. If you look at the median PFS for RVd in this setting in those two Phase II trials, it's in the range of 35 months to 40 months. That is our assumption when we at J&J designed this trial for CARTITUDE-5.

歷史上，如果你看 RVd 在一線、這個不適合移植族群中的表現，有兩個試驗。一個是由 Celgene 執行的 IFM 試驗。另一個是 SWOG S0777 試驗。如果你看這兩個第二期試驗中 RVd 在此情境下的中位無惡化存活期（PFS），大約落在 35 個月到 40 個月。這就是我們在 J&J 設計 CARTITUDE-5 試驗時所採用的假設。

Again, we're looking at cross-trial comparison, as you rightfully mentioned, 35 to 40 months. If you recall, Sean, in CARTITUDE-1, where we enrolled 97 patients with heavily pretreated regimen, the median line of therapy, prior therapy was 6.5, yet we still achieved 35-month PFS for CARVYKTI treated patients. This is why we and J&J are highly confident that we will be able to achieve the superiority against RVd in this specific patient population. If you compare that to CEPHEUS and other trials, of course, you do see certain numbers shifting because of better standard of care.

同樣地，正如你所說，我們在做跨試驗比較時，基準是 35 到 40 個月。Sean，如果你還記得 CARTITUDE-1，我們納入了 97 位接受過高度前線治療的病患，先前治療的中位線數是 6.5，但 CARVYKTI 治療病患仍達到 35 個月的 PFS。這也是為什麼我們與 J&J 對於能在這個特定病患族群中相較 RVd 達到優效性（superiority）非常有信心。若與 CEPHEUS 及其他試驗相比，當然你會看到某些數字因標準治療改善而有所變動。

On the other hand, still, given what we know about CARTITUDE-1 and also CARTITUDE-4, where, with a median follow-up of nearly 3 years, we have not reached median PFS yet in that second to fourth line patient population. We remain highly confident that CARVYKTI will demonstrate superiority in PFS compared to RVd. That is our assumption here.

另一方面，基於我們對 CARTITUDE-1 以及 CARTITUDE-4 的了解——在後者中，近 3 年的中位隨訪下，我們在第二到第四線病患族群的中位 PFS 仍尚未達到——我們仍然非常有信心 CARVYKTI 在 PFS 上將優於 RVd。這就是我們在此的假設。

Ashwani Verma, UBS.

Ashwani Verma，UBS。

Thanks for taking our question. Maybe just on the CD19, CD20 CAR-T. Can you talk about the safety differentiation with some of the other programs out there? Some of these programs have seen CRS or ICANS or neutropenia. Are you confident that your program can have minimal to no cases of Grade 3 and above CRS and ICANS?

謝謝讓我們提問。想先問 CD19、CD20 CAR-T。你能談談相較於其他一些在研計畫，你們在安全性上的差異化嗎？有些計畫出現了 CRS、ICANS 或嗜中性球低下。你們是否有信心你們的計畫能將 3 級及以上的 CRS 與 ICANS 降到極少甚至沒有？

Then, just like secondly, on CARVYKTI, I mean, the 4Q to 1Q sequential growth in US is at 3%. Any seasonality dynamic going on there? Just like trying to understand what is the growth trajectory from here. Can you continue to see sequential growth for the rest of 2026 and any impact of MajesTEC-3 on CARVYKTI sales? Thanks.

其次，關於 CARVYKTI，我的意思是，美國市場從第 4 季到第 1 季的連續成長只有 3%。這裡是否有任何季節性因素？我只是想了解接下來的成長軌跡。你們是否能在 2026 年剩餘時間持續看到逐季成長？以及 MajesTEC-3 對 CARVYKTI 銷售是否會有任何影響？謝謝。

Thanks, Ash. I can answer the first question on the safety side. Certainly, safety is paramount for a novel platform in oncology patients. I cannot disclose specific clinical safety profile at this point. We have to wait until the clinical data is presented. What I can say is that safety is a key parameter we focus on from the get-go in the design phase. Our unique design mechanism as well as the CMC manufacturing process, I think that will provide differentiate the safety profile in clinic. In term of how the research data correlates with the clinical data, let's wait, stay tuned until we are ready to disclose clinical data. Thank you.

謝謝，Ash。我可以先回答第一個關於安全性的問題。對於腫瘤病患而言，新平台的安全性當然是最重要的。目前我無法披露具體的臨床安全性特徵。我們必須等到臨床數據公布。我能說的是，從一開始在設計階段，我們就把安全性作為關鍵參數來聚焦。我們獨特的設計機制以及 CMC 製造流程，我認為將能在臨床上帶來差異化的安全性表現。至於研究數據與臨床數據之間的關聯性，我們就先等待；在我們準備好披露臨床數據之前，請持續關注。謝謝。

And on the CARVYKTI performance in Q1, yes, coming out of the holidays there is a little bit of a lag in patient appointments as patients get re-upped in their insurance and they get rescheduled. We're very encouraged with the trends that we've seen in the patient bookings through the progress of the quarter and even beyond that. I would say that we would expect to see sequential growth, quarter-on-quarter both in the US and OUS for the remainder of this year.

關於 CARVYKTI 在第一季的表現，是的，假期過後，因為病患需要重新續保並重新安排就診時間，病患門診預約會有些許滯後。我們對本季進展過程中、甚至之後所看到的病患預約趨勢感到非常鼓舞。我會說，我們預期今年剩餘時間在美國與美國以外（OUS）市場都會看到環比成長、也就是一季比一季成長。

Ash, maybe, this is Ying. I want to add that you guys all follow IQVIA weekly scripts and weekly sales. As you can see, we had a very strong March followed by a very strong April. Now we're early in May, but again, ordering looks quite strong. You guys can track that every week. As we have mentioned before, it's not a zero-sum game. You see both TECVAYLI and daratumumab and you see CARVYKTI steadily growing in second line.

Ash，或許我補充一下，我是 Ying。我想補充的是，你們大家都在追蹤 IQVIA 的每週處方量與每週銷售。如你們所見，我們 3 月非常強勁，接著 4 月也非常強勁。現在才 5 月初，但同樣地，訂單看起來相當強勁。你們每週都可以追蹤到這些數據。如我們先前提到的，這不是零和遊戲。你會看到 TECVAYLI 與 daratumumab，也會看到 CARVYKTI 在二線治療中穩定成長。

Thank you.

謝謝。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Thanks so much for taking my question. Maybe just the first question, Alan, for you, the -- those seasonality that you mentioned in Q4 with some of the bags sort of remaining over and ultimately being infused in early Q1, and it seems like as you're moving upstream in Q1, J&J talked about having the same effect. Can you give us a little bit of a sense, kind of net-net, how that worked out on a quarter-over-quarter basis? Is that sort of phenomenon of just a little bit of a delay to infusion will continue as you're moving to second line?

非常感謝讓我提問。第一個問題可能想請教 Alan：你提到第四季的季節性因素，有些「袋子」有點延後，最後在第一季初才完成輸注；而且看起來你們在第一季往更早線別推進時，J&J 也談到有同樣的影響。你能否讓我們大概了解一下，整體（net-net）來看，這在季對季的基礎上是如何反映的？當你們往二線治療推進時，這種「只是輸注稍微延後」的現象是否會持續？

And then a question for in vivo for BCMA, can you maybe share a little bit about the construct itself? Are you using sort of the same camelid antibody targeting BCMA with the same dual epitope targeting? Is it sort of the same stem? Are you doing any de-targeting through the LDL receptor and CD3 to try to avoid the sort of liver uptake and the sink and reduce some of the ICANS and inflammation? Thank you.

另外一個關於 BCMA 的體內（in vivo）項目問題：你能否分享一下這個構建（construct）本身？你們是否使用同樣的駱駝科（camelid）抗體來標靶 BCMA，並採用相同的雙表位（dual epitope）標靶？是否是相同的骨架（stem）？你們是否透過 LDL 受體與 CD3 做任何去標靶（de-targeting），以避免肝臟攝取與「匯」（sink）效應，並降低部分 ICANS 與發炎？謝謝。

Yaron, it's Alan. I'll just go back to what I said previously, which is that we do continue to see a strong order flow both as the quarter progresses as well as Ying mentioned going into April and beyond. We do expect to continue to see the growth and in particular in that earlier-line setting, where we are gaining more and more patients, more and more referrals, setting us up well from a competitive standpoint as well.

Yaron，我是 Alan。我先回到我先前說過的：我們確實持續看到強勁的訂單流，不僅在本季進行期間如此，正如 Ying 提到的，進入 4 月及之後也是如此。我們預期成長會持續，特別是在更早線別的治療情境中；我們正在獲得越來越多病患、越來越多轉介，從競爭角度來看也讓我們處於很好的位置。

With regard to the BCMA compound, in term of the binder design, we are not ready to disclose special information at this point. On the platform side, I do want to add that we generate glycoprotein mutations on the virus itself, and therefore the engineered virus does not recognize the receptor. We use internally discovered and optimize the CD3 binder for T-cell targeting, which is differentiated from many other players in the space where they use existing CD3 binder borrowed from other purpose.

關於 BCMA 化合物，就結合子（binder）設計而言，我們目前尚未準備好在此時披露特定資訊。在平台方面，我想補充的是，我們會在病毒本身產生醣蛋白突變，因此工程化病毒不會辨識該受體。我們使用內部發現並優化的 CD3 結合子來進行 T 細胞標靶，這點與領域內許多其他參與者不同；他們使用的是既有、從其他用途借用的 CD3 結合子。

Thank you so much.

非常感謝。

Mitchell Kapoor, H.C. Wainwright.

Mitchell Kapoor，H.C. Wainwright。

Thank you for taking my question. This is (inaudible) sitting in for Mitchell Kapoor. I have a question on the LB2501, the in vivo CD19, CD20 program. You list the studies enrolling, and you have pointed to this in vivo data coming later in the year. Separately, you have Johnson & Johnson recently announcing it discontinued its ex vivo CD20 mono and CD19, 20 bi-CAR-T programs in LBCL. Without asking you to comment on their program specifically, I just want to get a sense of how you're thinking about the competitive bar for LB2501.

謝謝讓我提問。我是（聽不清）代替 Mitchell Kapoor 發言。我有一個關於 LB2501（體內 in vivo 的 CD19、CD20 項目）的問題。你們列出研究正在招募中，並指出今年稍晚會有這個 in vivo 數據出來。另外，Johnson & Johnson 最近宣布已停止其在 LBCL 的 ex vivo CD20 單靶以及 CD19/20 雙靶 bi-CAR-T 計畫。不請你評論他們的計畫本身，我只是想了解你們如何看待 LB2501 的競爭門檻（competitive bar）。

This is a dual targeting mechanism and cumulative data across all target-cells clinical data on the targets front comparing CD19 versus CD19, CD20 dual targeting mechanism do point to the promise of dual targeting in term of driving deeper and the more durable response.

這是一種雙重標靶機制；在標靶端，跨所有標靶細胞的臨床累積數據，將 CD19 單靶與 CD19/CD20 雙靶機制作比較，確實顯示雙靶在帶來更深且更持久反應方面具有潛力。

J&J recently announced that they discontinued their development program for the dual targeting mechanism, and I will not be able to comment on their specific rationale. But we do believe that the dual targeting mechanism provide benefit over the mono targeting. The in vivo data is evolving, and we are very much looking forward to disclose our clinical program.

J&J 最近宣布他們已停止雙重標靶機制的研發計畫，我無法評論他們的具體理由。但我們確實相信，雙重標靶機制相較於單靶具有優勢。體內（in vivo）數據仍在演進中，我們非常期待披露我們的臨床計畫。

Thank you.

謝謝。

Thank you. I'm showing no further questions in the queue at this time. I will now turn the call back over to the CEO, Ying Huang, for any closing remarks.

謝謝。我目前看到隊列中沒有其他問題。我現在把電話交回給執行長 Ying Huang，請她做結語。

Well, it's great hearing from everyone this morning. We are really pleased with the momentum of CARVYKTI. As you heard from Alan, we look forward to stronger quarters in the rest of the year, and we do expect sequential growth in both US and ex-US. We continue to see deepening penetration in the community and also in second line. We're actually all full speed on with our in vivo programs. We look forward to seeing you all at the upcoming major medical meetings. Thank you.

今天早上很高興聽到大家的分享。我們對 CARVYKTI 的動能感到非常滿意。正如你們從 Alan 那裡聽到的，我們期待今年剩餘時間的季度表現更強勁，並且確實預期美國與美國以外市場都將呈現環比成長。我們持續看到在社區端以及二線治療中的滲透率加深。我們的 in vivo 計畫也正全速推進。我們期待在即將到來的重要醫學會議上與各位見面。謝謝。

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and you may now disconnect.

各位女士、先生，今天的電話會議到此結束。感謝各位的參與，您現在可以掛線。