Legend Biotech Corp (LEGN) 2025 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to Legend Biotech's third quarter 2025 earnings call. (Operator Instructions) Please be advised that today's conference is being recorded.

女士們、先生們，感謝你們的耐心等待。歡迎參加傳奇生物2025年第三季財報電話會議。（操作人員指示）請注意，今天的會議正在錄音。

I would like now to turn the conference over to Jessie Yeung, Vice President of Investor Relations and Finance. Please go ahead.

現在我將把會議交給投資者關係和財務副總裁楊潔篪女士。請繼續。

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 third quarter of 2025 performance. Prior to this call, we issued a press release announcing our financing results for the quarter. You can find the press release on our IR website at legendbiotech.com.

早安.這是傳奇生物科技公司投資者關係及財務副總裁楊潔儀。感謝您今天參加我們的電話會議，共同回顧我們2025年第三季的業績。在本次電話會議之前，我們發布了一份新聞稿，公佈了本季的融資業績。您可以在我們的投資者關係網站 legendbiotech.com 上找到新聞稿。

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 have our President of R&D, Guowei joining the Q&A session.

今天與我一起參加電話會議的有公司執行長黃穎；公司 CARVYKTI 總裁艾倫·巴什；以及公司財務長卡洛斯·桑托斯。在發言結束後，我們將開放問答環節。我們的研發總裁國偉將參加問答環節。

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 Investors Section of our company website.

在今天的電話會議中，我們將發表一些前瞻性聲明，這些聲明存在風險和不確定性，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。這些前瞻性聲明在我們的美國證券交易委員會文件中進行了更詳細的討論，我們鼓勵您閱讀這些文件，這些文件可以在我們公司網站的投資者關係部分找到。

In addition, adjusted net income or loss is a non-IFRS metric. This month, IFRS financial measures 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 new locations related to the use of these non-IFRS financial measures versus the closest IFRS equivalents.

此外，調整後的淨收入或虧損並非國際財務報告準則指標。本月，IFRS財務指標是依照IFRS編製的財務績效指標的補充，而非替代或優於後者。使用這些非 IFRS 財務指標與最接近的 IFRS 等效指標相比，出現了一些新的情況。

However, we believe that providing information concerning adjusted net income or loss and adjusted net income or loss per share enhances and investors' understanding of our financial performance. We use adjusted net income or loss as a performance metric that guides management in its operation and planning for the future of the business. We believe that adjusted net income or loss provides a useful measure of our operating performance from period to period.

但是，我們認為，提供有關調整後淨收入或虧損以及調整後每股淨收入或虧損的信息，可以增進投資者對我們財務業績的了解。我們使用調整後的淨收入或虧損作為績效指標，指導管理階層進行業務運作和未來規劃。我們認為，調整後的淨利或虧損能夠有效地衡量我們各時期的經營績效。

Our press release includes IFRS to non-IFRS reconciliation for these measures. With that, I will now turn the call over to Ying.

我們的新聞稿包含了這些措施的 IFRS 與非 IFRS 調節表。接下來，我將把通話交給瑩。

Hello, everyone. Thank you for joining us today. The third quarter was marked by significant milestones that I will elaborate on momentarily. And we are looking forward to presenting new data at the Annual American Society of Hematology meeting in December.

大家好。感謝您今天蒞臨。第三季取得了一些重要的里程碑式成就，我稍後會詳細說明。我們期待在 12 月舉行的美國血液學會年會上展示新的數據。

During the third quarter, CARVYKTI net trade sales were approximately $524 million, which is an 84% increase year-over-year. We have now treated over 9,000 patients with CARVYKTI, and our launch remains the strongest CAR-T launch to date. In the US, the majority of our utilization is in the earlier line setting.

第三季度，CARVYKTI 的淨貿易銷售額約為 5.24 億美元，年增 84%。我們目前已使用 CARVYKTI 治療了超過 9,000 名患者，我們的產品上市仍然是迄今為止最成功的 CAR-T 產品上市。在美國，我們的大部分利用率都集中在早期生產線設定中。

Additionally, we continue to see a lot of excitement about our long-term survival data presented at ASCO on CARTITUDE-1. As a reminder, one-third of patients with heavily pretreated relapsed/refractory multiple myeloma remain alive and progression-free for five years or more after being treated with CARVYKTI. This is especially impressive considering that today's bridging protocol did not exist at the time of the CARTITUDE-1 trial, and patients in the trial had received a median of 6.5 prior lines of therapy.

此外，我們在 ASCO 上公佈的 CARTITUDE-1 的長期存活數據也引起了廣泛關注。提醒大家，接受 CARVYKTI 治療後，三分之一曾接受過大量治療的復發/難治性多發性骨髓瘤患者仍能存活五年或更長時間，且病情未進展。考慮到 CARTITUDE-1 試驗時還沒有今天的橋接治療方案，而且試驗中的患者平均接受過 6.5 線之前的治療，這一結果尤其令人印象深刻。

Ever since our CARTITUDE-1 results were first presented in 2020, we have been setting new standards for efficacy in CAR-T for multiple myeloma. We're now changing that standard to curative potential. In fact, a recent article from Nature stated that one-third of the treated individuals had no evidence of detectable myeloma after five years without further therapy, an outcome widely thought of as a prerequisite to consider using the term cure.

自從我們在 2020 年首次公佈 CARTITUDE-1 研究結果以來，我們一直在為 CAR-T 療法治療多發性骨髓瘤的療效設定新的標準。我們現在將這項標準改為治療潛力。事實上，《自然》雜誌最近的一篇文章指出，接受治療的患者中有三分之一在五年後無需進一步治療，也沒有發現可檢測到的多發性骨髓瘤，這一結果被廣泛認為是考慮使用「治癒」一詞的先決條件。

This kind of efficacy for heavily pretreating patients is unprecedented in the field of multiple myeloma. On the regulatory front, the FDA recently approved an update to include CARVYKTI's overall survival benefit in this label.

對於經過大量預先治療的患者而言，這種療效在多發性骨髓瘤領域是前所未有的。在監管方面，FDA 最近批准了一項更新，將 CARVYKTI 的整體生存獲益納入該標籤。

This was based on an analysis from the Phase III CARTITUDE-4 study showing a statistically significant improvement in overall survival for CARVYKTI compared to the standard of care therapy in patients with relapsed refractory multiple myeloma after one to three prior lines of therapy.

這是基於 III 期 CARTITUDE-4 研究的分析，該研究顯示，對於接受一至三線治療的複發難治性多發性骨髓瘤患者，CARVYKTI 與標準治療相比，在總生存期方面有統計學意義上的顯著改善。

Importantly, CARVYKTI is the only approved CAR-T in multi-myeloma with a demonstrated overall survival benefit in this label, which represents another step forward towards educating the physician community on CARVYKTI's unique profile as we work to bring CARVYKTI to more second-line patients in need across the United States. We expect label updates such as these and previous REMS updates will continue to improve the patient experience and enhance access in both community and academic settings.

重要的是，CARVYKTI 是目前唯一獲準用於治療多發性骨髓瘤的 CAR-T 療法，在該適應症範圍內已證實具有總生存獲益，這代表著我們在向醫生群體普及 CARVYKTI 的獨特優勢方面又向前邁進了一步，我們將努力把 CARVYKTI 帶給美國各地更多需要二線治療的患者。我們預計此類標籤更新以及先前的 REMS 更新將繼續改善患者體驗，並增強社區和學術機構的醫療服務可近性。

In fact, I want to share findings from a recent survey that was presented at the International Myeloma Society Meeting, where 237 patients and 267 physicians were represented across US, UK, Spain, France, Germany, Italy, Japan and Brazil. In terms of what patients value when selecting a new line of treatment, overall survival was clearly the most important attribute for patients. Also on the topic of survival, we are pleased that there will be two oral presentations on CARVYKTI at this year's upcoming ASH meeting.

事實上，我想分享最近在國際骨髓瘤協會會議上發表的一項調查結果，該調查共有來自美國、英國、西班牙、法國、德國、義大利、日本和巴西的 237 名患者和 267 名醫生參加。就患者在選擇新的治療方案時所重視的因素而言，總存活期顯然是患者最重視的因素。關於生存問題，我們很高興地宣布，今年即將舉行的 ASH 會議上將有兩場關於 CARVYKTI 的口頭報告。

Before we dive deeper into this, I want to highlight that there will be an oral presentation at ASH on LCAR-G39D, our first-in-class allogeneic gamma delta T CAR-T cell therapy targeting both CD19 and CD20 in adults with relapsed/refractory B-cell non-Hodgkin's lymphoma.

在我們深入探討之前，我想強調的是，我們將在 ASH 上就 LCAR-G39D 進行口頭報告，這是我們首創的同種異體 γδ T CAR-T 細胞療法，可同時靶向 CD19 和 CD20，用於治療復發/難治性 B 細胞非霍奇金淋巴瘤成人患者。

As you may have seen in the abstract, we are pleased that preliminary efficacy showed an encouraging response rate and sustained durability in patients. Turning to the CARVYKTI oral presentations. Based on the CARTITUDE-4 subgroup analysis, 80% of patients with standard risk cytogenetics were progression-free and off treatment at 2.5 years.

正如您在摘要中可能看到的，我們很高興初步療效顯示出令人鼓舞的反應率和持續的療效。接下來是CARVYKTI的口頭報告。根據 CARTITUDE-4 亞組分析，80% 的標準風險細胞遺傳學患者在 2.5 年時未出現疾病進展且已停止治療。

In patients with standard risk disease who achieved MRD-negative CR at one year, this rate increased to 100% -- the low rate of progression events in CARVYKTI treated patients with standard risk cytogenetics shows the profound benefit of a single infusion in this population.

對於一年後達到 MRD 陰性 CR 的標準風險疾病患者，該比率增加到 100%——CARVYKTI 治療的標準風險細胞遺傳學患者的低進展事件發生率表明，單次輸注對該人群具有顯著益處。

In the second oral presentation on CARVYKTI, based on correlated biomarker data, longer PFS is associated with better immune fitness at baseline and stronger immune responses post CARVYKTI infusion. As observed in peripheral blood and within the tumor microenvironment of patients with relapsed refractory multiple myeloma in CARTITUDE-1 and CARTITUDE-4 studies.

在第二次關於 CARVYKTI 的口頭報告中，基於相關的生物標記數據，更長的 PFS 與基線時更好的免疫健康狀況和 CARVYKTI 輸注後更強的免疫反應相關。在 CARTITUDE-1 和 CARTITUDE-4 研究中，在復發難治性多發性骨髓瘤患者的周邊血液和腫瘤微環境中觀察到了這一點。

The peripheral immune fitness was more pronounced in patients with one and prior line of therapy versus three prior lines of therapy and beyond, where deterioration plateaued.

與接受過第三線及以上治療的患者相比，接受過一線及以上治療的患者外周免疫功能下降更為明顯，而接受過三線及以上治療的患者外周免疫功能下降則趨於穩定。

Similarly on this topic, on the next slide, featuring data we presented at ASCO, you can see that while CARVYKTI has a favorable benefit risk profile across all different subgroups and lines of therapy, its PFS improvement diminishes with each line of therapy, which is why it's important to follow the latest International Myeloma Working Group guidelines on obtaining CAR-T therapy as early as first relapse.

同樣地，關於這個主題，在下一張幻燈片中，我們展示了在 ASCO 上公佈的數據，您可以看到，雖然 CARVYKTI 在所有不同的亞組和治療線中都具有良好的獲益風險特徵，但其 PFS 改善隨著治療線的增加而減少，因此遵循國際骨髓瘤工作組關於在首次復發時儘早接受 CAR-T 治療的最新指南非常重要指南。

This slide also contextualizes the significance of our efficacy data from CARTITUDE-1, where there were 6.5 million prime lines of therapy and CARVYKTI still demonstrated a median PFS of 35 months. As we approach 10,000 annualized dose manufacturing capacity, we continue to extend our leadership in cell therapy through further advancing the field of CAR-T in multiple myeloma.

這張投影片也闡明了我們在 CARTITUDE-1 研究中獲得的療效數據的重要性，該研究納入了 650 萬例主要治療方案，而 CARVYKTI 的中位 PFS 仍達到了 35 個月。隨著我們年化劑量生產能力接近 10,000 劑，我們將繼續透過進一步推進 CAR-T 療法在多發性骨髓瘤領域的應用，鞏固我們在細胞療法領域的領先地位。

We recently initiated another study called CARTITUDE-10, which is a Phase II multi-cohort trial to further characterize the efficacy and safety of CARVYKTI, which speaks to our commitment to investigating new product goals.

我們最近啟動了另一項名為 CARTITUDE-10 的研究，這是一項 II 期多隊列試驗，旨在進一步描述 CARVYKTI 的療效和安全性，這體現了我們致力於探索新產品目標的決心。

Furthermore, a recent blood paper on effective bridging strategies across 20 centers found that among the 119 patients who proceeded to CAR-T therapy after receiving (technical difficulty) including 98 patients receiving CARVYKTI.

此外，最近一篇關於 20 個中心有效橋接策略的血液論文發現，在接受（技術困難）治療後繼續接受 CAR-T 治療的 119 名患者中，有 98 名患者接受了 CARVYKTI 治療。

Not only were these deep responses, sustained soluble B-cell maturation energy decline and consistent CAR-T expansion, there were also no cases of peripheral neuropathy, parkinsonism, or colitis reported. As we focus on educating the physician community on our overall survival benefit based on the extensive CARVYKTI data that's been generated, we're also taking the opportunity to remind physicians about the latest research on bridging therapy and ALC monitoring as well as the most recent IMWG guidelines on CAR-T.

不僅這些反應很強烈，可溶性 B 細胞成熟能量持續下降，CAR-T 細胞持續擴增，也沒有報告週邊神經病變、帕金森氏症或結腸炎病例。在我們致力於根據 CARVYKTI 產生的大量數據向醫生群體普及我們的整體生存獲益的同時，我們也藉此機會提醒醫生們注意橋接治療和 ALC 監測的最新研究，以及 IMWG 關於 CAR-T 的最新指南。

In a few moments, you'll hear from Alan on how we and our partner, Johnson & Johnson, are bringing CARVYKTI to more multiple myeloma patients in need. In light of the demand, we continue to see across the US and overseas we are moving full steam ahead on our capacity expansion plans.

稍後，您將聽到 Alan 講述我們和我們的合作夥伴強生公司如何將 CARVYKTI 帶給更多需要的多發性骨髓瘤患者。鑑於市場需求，我們在美國和海外持續推進產能擴張計畫。

On a final note, on CARVYKTI before we turn to our pipeline, we continue to expect to complete enrollment for CARTITUDE-5, 6 this year. We believe the CARTITUDE-5 and 6 trials are key to moving CARVYKTI into the frontline setting.

最後，在談到我們的研發項目之前，關於 CARVYKTI，我們仍然預計今年將完成 CARTITUDE-5、6 的招生工作。我們認為 CARTITUDE-5 和 6 試驗是 CARVYKTI 進入第一線應用的關鍵。

Looking ahead at our long-term growth, in addition to looking forward moving carve into the frontline. We remain focused on solidifying our leadership in cell therapy more broadly. We are making progress in new indications such as solid tumor and NHL programs, as you have seen with the data at recent medical conferences.

展望我們的長期發展，除了展望未來進軍第一線之外，還要展望未來。我們將繼續致力於鞏固我們在細胞療法領域的領先地位。正如您在最近的醫學會議上看到的數據所示，我們在實體瘤和非何杰金氏淋巴瘤等新適應症方面取得了進展。

Additionally, we are looking forward to the ribbon-cutting ceremony tomorrow for our new research facility in Philadelphia, where in vivo delivery will be one of its key focuses, positioning us well to pursue this area of innovation. We remain excited about this new frontier of cell therapy.

此外，我們期待明天在費城舉行的新研究設施的剪綵儀式，該設施的重點之一是體內遞送，這將使我們能夠更好地推進這一創新領域。我們對細胞療法這一新領域依然充滿熱情。

To sum up, Legend is the largest stand-alone cell therapy company with over 9,000 CARVYKTI patients treated as we forged the path to cure. With a cash position of nearly $1 billion, we are investing in our core differentiators in cell therapy and remain focused on delivering operational efficiency in order to ensure durable long-term growth.

總而言之，Legend 是最大的獨立細胞療法公司，我們已治療了超過 9,000 名 CARVYKTI 患者，並開闢了治癒之路。我們擁有近 10 億美元的現金儲備，正在投資於我們在細胞療法方面的核心差異化優勢，並將繼續專注於提高營運效率，以確保持久的長期成長。

We continue to anticipate achieving profitability for CARVYKTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses. And with that, I'll pass it over to Alan to provide an update on CARVYKTI.

我們繼續預期 CARVYKTI 將在 2025 年底實現獲利，並在 2026 年實現公司整體獲利（不包括未實現的匯兌損益）。接下來，我將把麥克風交給艾倫，讓他為大家帶來 CARVYKTI 的最新情況。

Thank you, Ying. CARVYKTI remains the undisputed leader of CAR-T sales in a single quarter with net trade sales of $524 million during the third quarter. In addition to being the highest selling CAR-T ever, CARVYKTI has also achieved a CAGR of 111% since launch, which is unmatched in this class.

謝謝你，穎。CARVYKTI 仍然是 CAR-T 單季銷售額無可爭議的領導者，第三季淨貿易銷售額為 5.24 億美元。除了是有史以來銷量最高的 CAR-T 車型外，CARVYKTI 自上市以來還實現了 111% 的複合年增長率，這在同類車型中是無與倫比的。

Despite these record-setting numbers, we continue to believe there is significant opportunity for further market penetration for CARVYKTI, given the magnitude of the addressable multiple myeloma market opportunity for CAR-T. While we are continuing to expand our footprint of authorized treatment centers in the US, the next frontiers of growth are also expected to come from expanding our presence in the community setting in the US and expanding our market leadership outside the US.

儘管取得了這些創紀錄的數字，但鑑於 CAR-T 療法在多發性骨髓瘤市場的巨大潛力，我們仍然相信 CARVYKTI 有進一步滲透市場的巨大機會。雖然我們正在不斷擴大在美國的授權治療中心規模，但下一個增長點預計也將來自擴大我們在美國社區的影響力以及擴大我們在美國以外的市場領導地位。

Diving deeper into our performance this quarter, CARVYKTI net trade sales grew 84% year-over-year and 19% from the second quarter. Our global growth was driven by continued share gains and site expansion. US net trade sales of $396 million grew 53% year-over-year and 11% quarter-over-quarter.

深入分析本季業績，CARVYKTI 淨貿易銷售額年增 84%，季增 19%。我們的全球成長得益於市場佔有率的持續提升和業務範圍的擴大。美國淨貿易銷售額為 3.96 億美元，年增 53%，季增 11%。

Quarter-over-quarter growth in the US was primarily driven by continued strong demand with 60% utilization in earlier-line settings. Regarding our performance outside the US, we had sales of $128 million which is nearly 5 times the amount over the same period a year ago and represents a 58% increase quarter-over-quarter. Our performance outside the US was driven not only by continued growth in Germany, but by strong launches in Spain and Belgium.

美國季度環比成長主要得益於持續強勁的需求，早期生產線的利用率達到 60%。就我們在美國以外的業績而言，我們的銷售額為 1.28 億美元，幾乎是去年同期的 5 倍，環比成長 58%。我們在美國以外的業績成長不僅得益於德國市場的持續成長，也得益於西班牙和比利時市場的強勁表現。

In terms of supply tailwinds to further build upon our CAR-T market leadership in multiple myeloma, I would like to provide some incremental updates since the second quarter. We are proud to announce that our manufacturing network growth and continued efficiencies mean that we are now able to fully supply the demand and there is no longer a wait for patients.

關於有助於我們進一步鞏固在多發性骨髓瘤領域 CAR-T 市場領先地位的供應利好因素，我想提供一些自第二季度以來的最新進展。我們很自豪地宣布，隨著生產網路的成長和效率的不斷提高，我們現在能夠完全滿足需求，患者不再需要等待。

We expect both supply and demand will continue to expand together to help ensure a seamless customer experience. In the US, we are currently in the final stages of the expansion of the Raritan facility that will significantly expand capacity to support continued US market growth.

我們預計供應和需求將繼續同步成長，以確保為客戶提供流暢的體驗。在美國，我們目前正處於拉里坦工廠擴建的最後階段，這將大幅提高產能，以支持美國市場的持續成長。

As it relates to supporting growth outside the US. I am pleased to announce that our Tech Lane facility recently initiated commercial production. This is an important milestone for serving patients in Europe to meet the increasing demand.

就支持美國以外地區的成長而言。我很高興地宣布，我們的 Tech Lane 工廠最近已開始商業化生產。這是為滿足歐洲患者日益增長的需求而提供服務的一個重要里程碑。

Turning to demand drivers. First, of course, is the recent unprecedented long-term survival data that we presented at ASCO on CARTITUDE-1. Second is our demonstrated overall survival benefit, which has now been added to the US label. We are focused on educating both treating and referring physicians in the academic and community settings on how CARVYKTI is the first and only multiple myeloma cell therapy via a single infusion to significantly extend overall survival versus standard therapies and on our long-term survival data.

轉向需求驅動因素。首先，當然是我們最近在 ASCO 上公佈的關於 CARTITUDE-1 的前所未有的長期生存數據。其次，我們已證實其整體生存獲益，目前已將其添加到美國藥品標籤中。我們致力於向學術界和社區的治療醫生和轉診醫生普及 CARVYKTI 如何成為首個也是唯一一個通過單次輸注即可顯著延長總生存期的多發性骨髓瘤細胞療法，並與標準療法進行比較，同時我們也將介紹我們的長期生存數據。

In the community setting, we continue to raise awareness, drive referrals, and educate oncologists and nursing staff on managing patients once they transition back to their offices. And as Ying mentioned, we are also educating them on the IMWG guidelines and the importance of treating eligible patients as early as possible to take advantage of T-cell fitness and potentially improve survival outcomes.

在社區層面，我們繼續提高公眾意識，推動轉診，並教育腫瘤科醫生和護理人員如何在患者返回診室後對其進行管理。正如 Ying 所提到的，我們也在向他們普及 IMWG 指南，以及儘早治療符合條件的患者的重要性，以便利用 T 細胞功能並有可能改善存活結果。

Lastly, in the US, the number of authorized treatment centers now stands at 131 sites across the US, with about one-third of our sites being community and regional hospitals, which serve an important need in the community setting. We are also pleased with the discussions we've had with many stakeholders about the need to bring CAR-T even closer to the community and with adoption by community networks or practices.

最後，在美國，目前已授權的治療中心數量為 131 個，遍布全美各地，其中約三分之一是社區和區域醫院，滿足了社區的重要需求。我們也很高興與許多利害關係人就如何讓 CAR-T 更貼近社區以及社區網絡或實踐採用 CAR-T 進行了討論。

Our early experience with Virginia Oncology associates indicates that this is an area of large need and opportunity. Currently, we estimate that 80% of myeloma patients live within 5 miles of a CARVYKTI authorized treatment center. While that is strong coverage, we think we can do even better over the next one to two years. And outside the US, we will continue to benefit from the new launches.

我們與維吉尼亞腫瘤協會的早期合作經驗表明，這是一個需求龐大且充滿機會的領域。目前，我們估計 80% 的多發性骨髓瘤患者居住在 CARVYKTI 授權治療中心 5 英里範圍內。雖然目前的覆蓋範圍已經很強，但我們認為在未來一到兩年內我們可以做得更好。在美國以外，我們將繼續受益於新產品的推出。

And with reference to new markets, we are proud to say that we have currently launched in markets around the world. With the help of our partner, Johnson & Johnson, we have activated 246 treatment sites. We continue to be excited about bringing CARVYKTI to more eligible patients in Denmark, Sweden, Belgium, Luxembourg, Spain, Portugal Saudi Arabia and the private markets of Israel and the UK.

至於新市場，我們很自豪地說，我們目前已在全球多個市場推出產品。在合作夥伴強生公司的幫助下，我們已經啟用了 246 個治療點。我們將繼續為丹麥、瑞典、比利時、盧森堡、西班牙、葡萄牙、沙烏地阿拉伯以及以色列和英國的私人市場中更多符合條件的患者帶來 CARVYKTI。

With the approval of commercial production at our Tech Lane facility, we are well on our way to being able to treat over 10,000 patients on an annualized basis around the world. Now it's time to take a closer look at the financials. So I'll turn the call over to Ying as we provide a warm welcome to Carlos.

隨著我們在 Tech Lane 工廠的商業化生產獲得批准，我們正朝著每年在全球範圍內治療超過 10,000 名患者的目標穩步邁進。現在是時候仔細看看財務狀況了。那麼，我將把電話交給 Ying，讓我們一起熱烈歡迎 Carlos 的到來。

Thank you, Alan. As many of you already know, in August, we announced that Carlos Santos who's joining Legend as our new Chief Financial Officer. I'd like to extend my gratitude to Jessie Yeung for her outstanding leadership and significant contributions in guiding our finance organization prior to Carlos's arrival.

謝謝你，艾倫。正如你們中的許多人已經知道的那樣，我們在 8 月宣布 Carlos Santos 將加入 Legend 擔任新的財務長。我謹向楊小姐表示衷心的感謝，感謝她在卡洛斯到來之前對我們財務部門的出色領導和重大貢獻。

Carlos joins Legend from AstraZeneca where he held various positions over the last 10 years, including CFO for US Oncology, CFO of Latin America business and acting Aria VP of the Latin America Commercial unit. His extensive experience in the biotech sector and wealth of financial leadership expertise will be invaluable as we continue to execute on our commercial and clinical plans and seek to attain company-wide profitability in 2026.

Carlos 加入 Legend 之前曾在阿斯特捷利康工作 10 年，擔任美國腫瘤業務首席財務官、拉丁美洲業務首席財務官以及 Aria 拉丁美洲商業部門代理副總裁等多個職位。他在生物技術領域的豐富經驗和豐富的財務領導才能將對我們繼續執行商業和臨床計劃，並力爭在 2026 年實現公司整體盈利起到至關重要的作用。

We are pleased to welcome Carlos to our executive team.

我們很高興歡迎卡洛斯加入我們的管理團隊。

Thank you, Ying. And good morning, everyone. I am very excited to join Legend at this pivotal moment in its global development and growth. After my first three months here and visiting our Tech Lane facility, I can confidently say that there is a clear vision and path for Legend to be the global leader in cell therapy. I also see a strong path to profitability through our revenue growth and operational efficiency.

謝謝你，穎。大家早安。我非常高興能在傳奇影業全球發展壯大的關鍵時刻加入該公司。在我來到這裡三個月並參觀了我們的 Tech Lane 工廠之後，我可以自信地說，Legend 有明確的願景和發展路徑，要成為細胞治療領域的全球領導者。我也看到了透過收入成長和營運效率提升來實現盈利的良好途徑。

First of all, CARVYKTI continues to grow at a strong rate with net sales up 84% year-over-year in the third quarter. And as Alan mentioned, we have a number of tailwinds that should continue to generate demand in the vast multiple myeloma market. I believe there's a significant opportunity for growth in the community setting, especially with our unique outpatient administration advantage, which provides physicians with flexibility.

首先，CARVYKTI 繼續保持強勁成長勢頭，第三季淨銷售額年增 84%。正如艾倫所提到的，我們有很多有利因素，這些因素應該會繼續在龐大的多發性骨髓瘤市場中產生需求。我認為社區醫療領域有很大的發展機會，尤其是我們獨特的門診管理優勢，這為醫生提供了靈活性。

As Ying has mentioned previously, both CARTITUDE-5 and CARTITUDE-6 approvals have the potential to significantly expand the opportunity for our already proven commercial therapy, CARVYKTI. In terms of Legend's operational efficiency, our operating expenses as a percentage of revenue have significantly improved over the last 12 months due to our focus on disciplined expense management and increasing automation throughout our organization, and we continue to look at ways to further unlock efficiencies.

正如 Ying 之前提到的，CARTITUDE-5 和 CARTITUDE-6 的批准都有可能大大擴大我們已證明有效的商業療法 CARVYKTI 的機會。就 Legend 的營運效率而言，由於我們專注於嚴格的費用管理和提高整個組織的自動化程度，過去 12 個月我們的營運費用佔收入的百分比已顯著改善，我們將繼續尋找進一步提高效率的方法。

Drilling deeper into our third quarter, we delivered solid financial results with CARVYKTI net sales up 84% year over year. Total revenues were $272 million, driven by collaboration revenue growth of 84% year over year.

深入分析我們第三季的情況，我們取得了穩健的財務業績，CARVYKTI 淨銷售額年增 84%。總收入為 2.72 億美元，其中合作收入較去年同期成長 84%。

In Q3, we delivered a $40 million net loss, but was $19 million on an adjusted net loss basis, after excluding items that are not representative of the company's core business, such as $15 million in stock-based compensation. Importantly, our operating loss of $70 million in the same period one year ago was reduced by 38% to a $43 million operating loss during the third quarter.

第三季度，我們淨虧損 4,000 萬美元，但經調整後淨虧損為 1,900 萬美元，這是因為剔除了不代表公司核心業務的項目，例如 1,500 萬美元的股票選擇權費用。值得注意的是，我們去年同期的營業虧損為 7,000 萬美元，而第三季的營業虧損減少了 38%，降至 4,300 萬美元。

This meaningful improvement in operating results was driven by our operational efficiency and disciplined expense management. Even though we continue to invest in our robust pipeline and supporting the second-line indication launch and our manufacturing capacity. Our third quarter gross margin on net product sales remained consistent at 57%.

營運績效的顯著提升得益於我們高效率的營運和嚴格的費用管理。儘管我們持續投資於我們強大的產品線，並支持二線適應症的推出和我們的生產能力。第三季淨產品銷售毛利率維持穩定在 57%。

As expected, R&D expense on an IFRS basis grew slightly to $113 million or 42% of revenue, while SG&A on an IFRS basis grew 10% from the prior year to $87 million in the third quarter or 32% of revenue.

如預期，以國際財務報告準則計算，研發費用略為成長至 1.13 億美元，佔營收的 42%；而以國際財務報告準則計算，銷售、管理及行政費用較上年同期成長 10%，第三季達到 8,700 萬美元，佔營收的 32%。

Overall, we have made significant progress on operating cash flow generation as evidenced by our $29 million in cash flow from operations this quarter and we are continuing to make strides towards profitability. Our adjusted diluted earnings per share was a negative $0.05 compared to a negative $0.11 for the same period last year.

總體而言，我們在經營現金流產生方面取得了顯著進展，本季經營現金流達到 2,900 萬美元，這足以證明這一點，而且我們正在繼續朝著獲利目標邁進。經調整後的稀釋每股收益為負 0.05 美元，去年同期為負 0.11 美元。

Now turning to capital allocation. We have maintained a strong balance sheet with approximately $1 billion in cash and equivalents and time deposits. We will continue to prioritize disciplined expense management as we fund our operating and capital expenditures, including future innovation until we achieve company-wide profitability, excluding foreign exchange gains and losses, which we anticipate in 2026.

現在來談談資本配置。我們維持穩健的資產負債表，擁有約10億美元的現金及現金等價物和定期存款。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，直到我們實現公司整體盈利（不包括外匯損益），我們預計在 2026 年實現這一目標。

In summary, our third-quarter results demonstrate continued commercial execution supported by CARVYKTI's unique clinical outcomes along with increased operational efficiency. We are also pleased with our progress towards pioneering next-generation cell therapy treatments as we leverage our unique innovation model to maximize our cell therapy platform.

總而言之，我們第三季的業績表明，在 CARVYKTI 獨特的臨床成果和不斷提高的營運效率的支持下，商業執行持續推進。我們也對我們在開拓下一代細胞療法方面取得的進展感到滿意，因為我們利用我們獨特的創新模式來最大限度地發揮我們的細胞療法平台的作用。

And now it's time to take your questions. Operator, we're ready for the first question, please.

現在是提問環節。接線員，我們準備好回答第一個問題了。

(Operator Instructions) Gena Wang, Barclays.

（操作說明）Gena Wang，巴克萊銀行。

Carlos, congratulations on the new position. since you closed the remarks, maybe I will ask you. I know 2026, we should start to see positive cash flow and if given the robust revenue that CARVYKTI could generate. You actually in 2026, there could be very decent in full cash. So maybe I wanted to ask you with this increased cash in hand, what will be the best way to prioritize the cash and then in terms of the pipeline assets?

卡洛斯，恭喜你榮升新職。既然你已經結束了發言，也許我可以問你一些問題。我知道，如果 CARVYKTI 能夠產生強勁的收入，那麼到 2026 年，我們應該會開始看到正現金流。實際上，到 2026 年，你可能會獲得非常可觀的全額現金。所以我想問的是，有了這筆增加的現金，如何才能最好地優先考慮這筆現金以及管道資產？

And then I have a very quick question regarding the ASH abstract. I do know both J&J and Legend actually withdraw a presentation of a comparison between IMAGINE-1 and CARTITUDE-1. So maybe, Ying if you can or Alan, if you can give a little bit more insight regarding the rationale behind it?

然後我還有一個關於 ASH 摘要的簡短問題。我知道強生公司和 Legend 公司實際上都撤回了 IMAGINE-1 和 CARTITUDE-1 的對比演示。所以，Ying或Alan，如果可以的話，能否再詳細解釋一下背後的原因？

And then lastly, very quickly regarding the Raritan site. I know you did say like a second half, that should be complete completion of expansion. And given we only have less than two months left. Should we expect everything is on track? Is the -- I know that the last step would need to be signed off by the FDA. And should we expect that should happen before year-end '25?

最後，簡單談談拉里坦遺址。我知道你之前說過，就像後半部一樣，那應該是擴建工程的完全完成。而我們只剩下不到兩個月的時間了。我們是否可以認為一切都在按計劃進行？我知道最後一步需要美國食品藥物管理局（FDA）的批准。我們是否可以預期這種情況會在 2025 年底前發生？

Okay. Thank you, Gena. This is Carlos. In terms of your inquiry about how we're going to allocate cash given our profitability expected in 2026. I would say that first and foremost, we want to maximize our CARVYKTI franchise. So this is our priority in terms of capital allocation.

好的。謝謝你，吉娜。這是卡洛斯。關於您詢問我們如何根據 2026 年的預期獲利狀況分配現金的問題。首先，我們要做的就是最大限度地提高 CARVYKTI 特許經營權的利用率。所以這是我們在資本配置上的首要任務。

And as you know, we've been making significant capital investments in manufacturing and expanding our network. At the same time, we will also continue to significantly invest in our CAR-T platform. We're going to be looking into every opportunity to accelerate our existing programs that will strengthen our market leadership in CAR-T, including business development.

如您所知，我們一直在製造業和網路擴張方面進行大量資本投資。同時，我們也將繼續大力投資我們的 CAR-T 平台。我們將尋找一切機會來加速推進現有項目，以鞏固我們在 CAR-T 領域的市場領導地位，包括業務拓展。

And the yes, let me answer the other two questions. In terms of Raritan, the plan is very much on track to be able to have the facility expansion completed, and we've already started the submission process for that. So everything is on track for us to head into 2026 with the annualized doses for 10,000 doses, and that is complemented by, of course, as you know, the news we announced around the commercial production in Tech Lane. So now we have all four nodes operating on a commercial basis.

是的，讓我來回答另外兩個問題。就 Raritan 而言，該設施擴建計劃進展順利，我們已開始提交相關申請。因此，一切進展順利，我們將在 2026 年實現每年 10,000 劑的疫苗產量目標，當然，如您所知，我們也宣布了有關 Tech Lane 商業化生產的消息。現在我們所有四個節點都已投入商業營運。

I did want to just address your question on the abstract. So there was a poster from ASH that was withdrawn and due to the limited data available for ANIDA cell in the public domain at this point, the abstract was drawn in alignment with the authors, and we are looking forward to future opportunities to share the data.

我只想回答你關於摘要的問題。因此，ASH 撤回了一張海報，由於目前公共領域中 ANIDA 細胞的數據有限，摘要是根據作者的意見撰寫的，我們期待未來有機會分享這些數據。

Terence Flynn, Morgan Stanley.

Terence Flynn，摩根士丹利。

I just wondered -- I know you provided us with the ATC numbers, both in the U.S. and rest of world now. But as you look into 2026, where do you think those can go realistically? And then on the manufacturing capacity, again, great to hear all the progress there. You mentioned the 10,000 unit number now.

我只是想問一下——我知道你們現在已經向我們提供了美國和世界其他地區的空中交通管制號碼。但展望 2026 年，你認為這些目標現實中能達到什麼程度？至於生產能力方面，同樣很高興聽到這方面取得的所有進展。你剛才提到了10000台這個數字。

Again, when you kind of complete all of these ongoing efforts, where should that number end up approximately?

再說一遍，當你完成所有這些正在進行的工作後，這個數字最終大概會是多少？

So regarding the ATC as you mentioned, we're at 131. Actually, we have an update. We have 132 sites in the US. So combine that with the OUS, we're past the 250 mark for total number of sites, and that's a recent update. We continue to update this every single day as we watch it. And to your question about where it could go in '26, we have our sights on continuing to expand, for example, making sure that we have full coverage in the 160-plus sites that some of the competition has.

關於您提到的空中交通管制，我們目前是 131 號。實際上，我們有最新消息。我們在美國有132個站點。加上 OUS，站點總數已經超過 250 個，而且這是最近的更新。我們會持續關注，並每天更新報道。至於你問到它在 2026 年的發展方向，我們的目標是繼續擴張，例如，確保我們在一些競爭對手擁有的 160 多個站點實現全面覆蓋。

So as you hear from competitors around their network, we're very confident that in 2026 by the time they are launched that we'll be able to have coverage in the same vein. I will also add that as we look even ahead, the total number of sites in the US that have either started to do CAR-T or have seriously expressed interest and have started the process is something in the 180 number of sites, [Mark].

因此，正如您從競爭對手那裡聽到的那樣，我們非常有信心，到 2026 年他們推出服務時，我們將能夠提供相同程度的覆蓋。我還要補充一點，展望未來，美國已經開始進行 CAR-T 治療或認真表示有興趣並已開始進行該治療的機構總數約為 180 家。[標記]。

And we believe that we are well on track to be able to get there over time and then continue to expand further into the community setting. I will also address your question about the plan beyond 10,000.

我們相信，隨著時間的推移，我們能夠順利實現這一目標，並繼續進一步擴展到社區環境中。我也會回答你關於10000人之後計畫的問題。

So with all four nodes in the network, that being in the US, obviously, Raritan, the expansion there, Novartis, which continues to ramp for us and deliver and of course, in Europe with the increasing demand in Europe, we have the Tech Lane facility now coming online with full commercial production and Obelisc continuing to drive production, as well and gaining efficiencies.

因此，網路中的四個節點都位於美國，顯然包括 Raritan（其業務正在擴張）、諾華（其業務持續增長並為我們交付產品），當然還有歐洲（隨著歐洲需求的增長，我們的 Tech Lane 工廠現在已全面投入商業生產），而 Obelisc 也在繼續推動生產，並提高效率。

This is a network that we believe will enable us to get eventually to 20,000 doses annualized. And that's through not only continued ramp in all four of the nodes but also continued efficiencies, lowering the out of stack, improving the manufacturing success rates.

我們相信，透過這個網絡，我們最終能夠實現每年 20,000 劑疫苗的產量。這不僅得益於所有四個節點持續的產能提升，還得益於效率的持續提高，降低了堆疊溢位率，提高了製造成功率。

Eric Schmidt, Cantor.

埃里克·施密特，坎托爾。

As you move from a supply-constrained environment to a demand-constrained environment, what do you think the most important things are that you need to do to mobilize demand to fulfill your new supply and how quickly do you think you can get to essentially near full utilization of the 10,000 doses? Thank you.

當您從供應受限的環境過渡到需求受限的環境時，您認為為了調動需求以滿足新的供應，您最需要做的是什麼？您認為您能以多快的速度基本實現 10,000 劑疫苗的充分利用？謝謝。

This is Alan again. So in terms of accelerating demand, we have a number of plans in place to be able to do that. First of all, it's all about making sure that physicians around the US and around the world, really fully appreciate the benefits of treating earlier. And that's something that we have certainly gotten traction on, whether that's data that's coming out in the real world or some of the app flow-throughs that you see in presentations.

我是艾倫。因此，為了加速需求成長，我們已經制定了一系列計劃來實現這一目標。首先，最重要的是確保美國乃至全世界的醫生真正充分認識到早期治療的好處。而這正是我們已經取得進展的地方，無論是現實世界中的數據，還是你在簡報中看到的一些應用程式流程。

There's a broader and greater appreciation for the fact that efficacy is better when you treat in earlier lines the safety, the incidence of neurologic events and other adverse events is lower when you have patients treated in the earlier lines. You have improved T cell fitness, which is another aspect to have closer that's going to be at ASH. And as you see from the ASH posters, we also have data that clearly suggests that at the out spec rates are lower.

人們越來越認識到，早期治療可以提高療效，降低安全性，減少神經系統事件和其他不良事件的發生率。你們的 T 細胞健康狀況得到了改善，這是 ASH 會議上需要重點關注的另一個面向。正如您從 ASH 海報中看到的那樣，我們也有數據清楚地表明，不合格率較低。

So where everything is better earlier, and that's a key message that we'll continue to drive not only with the current authorized treatment centers, but also the referred in the community.

所以，一切都應該儘早好起來，這是我們將繼續努力傳達的關鍵訊息，不僅在目前獲得授權的治療中心，而且在社區轉介的治療中心也是如此。

Just to add one more point. We have a network as we talked about and the footprint today, but our community strategy is really based on not only continuing to leverage the one-third of sites that are in the community, the one-third of sites in our current network at our community and regional hospitals, but also driving referrals from the physician practices that are not in the network.

我再補充一點。正如我們剛才所討論的，我們擁有一個網絡，並且今天也擁有一定的覆蓋範圍，但我們的社區策略實際上不僅基於繼續利用我們目前在社區和區域醫院網絡中的三分之一的站點，還基於推動來自網絡外醫生診所的轉診。

And then ultimately, we're having conversations with some of the large practices such as the one you saw from our announcement earlier in the year in VOA to enable the community to actually start to administer CAR-T themselves.

最終，我們正在與一些大型醫療機構進行對話，例如您在今年早些時候透過美國之音發布的公告中看到的那家，以便讓社區能夠真正開始自行管理 CAR-T 療法。

And any sense on when you get to full capacity?

你們大概什麼時候會達到滿載運轉狀態？

Well, I think as we said today, we are -- our capacity is now meeting the demand in the marketplace. And as we're going to be increasing capacity, we'll also be increasing the demand as well.

嗯，我認為正如我們今天所說，我們的產能現在已經能夠滿足市場需求。隨著產能的提升，需求也會隨之增加。

I meant in terms of having almost 10,000 doses to dose in the near future. Do you think there's a time line to utilize that capacity?

我的意思是，在不久的將來，我們需要準備近 10,000 劑疫苗。你認為利用這項產能有時間表嗎？

Well, I think we'll be able to achieve those goals in 2026, and that translates into the consensus revenues that we see in 2026 or that have been issued for 2026. So we're very much on track for that.

我認為我們能夠在 2026 年實現這些目標，這將轉化為我們在 2026 年看到的或已經發布的 2026 年的預期收入。所以，我們目前進展非常順利。

Eric, this is Ying. Maybe I'll tell you that from where I sit, the latest data suggests that we're really running at nearly 100% capacity utilization at all four nodes right now. So we continue to expect that all four nodes will be utilized at very high capacity next year as well. Thank you.

艾瑞克，這是英。或許我可以告訴你，從我目前掌握的情況來看，最新數據顯示，我們現在所有四個節點的容量利用率都接近 100%。因此，我們仍然預計明年所有四個節點都將以非常高的容量被利用。謝謝。

Jessica Fye, JPMorgan.

潔西卡費伊，摩根大通。

This is [Dana] on for Jess. I really have just one question here. I wanted to ask you if you guys could throw some color on anything that would be watching out for at ASH from a competitive standpoint?

這是[Dana]替Jess主持節目。我其實只有一個問題。我想問各位，從競技角度來看，在ASH比賽中有哪些需要注意的地方？

I think in the absence of information -- sorry, it's Alan here. It might be the absence of information that is most relevant. We're fully ready and prepared to compete with a potential [BC] of a CAR-T that's coming out potentially next year. But I will say that we haven't seen the Kaplan-Meier curve from ANIDA Cell yet. So it's quite hard to know what that data is going to look like.

我認為在缺乏資訊的情況下——抱歉，我是艾倫。或許最關鍵的是資訊的缺失。我們已經做好充分準備，迎接明年可能上市的 CAR-T 療法的挑戰。但我要說的是，我們還沒看到 ANIDA Cell 的 Kaplan-Meier 曲線。所以很難知道這些數據會是什麼樣子。

But I will say that we're going to continue to be raising the bar on efficacy we have a significant advantage in terms of the efficacy that we've seen in the CARTITUDE-4 population in the subgroups in the earlier lines in CART-4 and over the next year, we're going to be also demonstrating the fact that just as we did in CAR-T.

但我要說的是，我們將繼續提高療效標準，我們在療效方面具有顯著優勢，我們在 CARTITUDE-4 人群、CART-4 早期治療的亞組中都看到了這一點，在接下來的一年裡，我們還將證明，就像我們在 CAR-T 中所做的那樣。

CARTITUDE-1 that CARTITUDE-4 has the long-term durability that physicians and patients are asking for. So we're very comfortable with the data that we're going to be presenting in terms of efficacy, and it's really just a question of when we might see that data from competition.

CARTITUDE-1 認為 CARTITUDE-4 具有醫生和病人所要求的長期耐用性。因此，我們對即將公佈的功效數據非常有信心，現在的問題只是我們何時才能看到競爭對手的數據。

Yes. And this is what -- on the pipeline side, we are also going to release early clinical data for our internal (technical difficulty) platform. And this is a product with a unique design and unique CMC process. We see a highly manageable safety profile and good expansion in oncology patients. The preliminary efficacy show encouraging response rate and also importantly, sustained durability.

是的。此外，在研發方面，我們也將發布我們內部（技術難度較高）平台的早期臨床數據。這是一款設計獨特、CMC工藝獨特的產品。我們看到其安全性良好，並且在腫瘤患者中應用前景廣闊。初步療效顯示出令人鼓舞的反應率，而且更重要的是，療效持久。

Jon Miller, Evercore.

Jon Miller，Evercore。

I'd love to dial in more on the community progress that you've made -- specifically in the VOA network, have you been treating patients there already? How has the uptake been going in that patient network? Do you have plans to expand beyond the Virginia network near term? And when you say that one-third of your sites are regional or community centers, I mean, I assume most of that is regional centers. Can you talk a little bit more about adoption expectations in the communities specifically as we head into '26?

我很想更深入地了解您在社區方面取得的進展——特別是在美國之音網絡方面，您是否已經在那裡治療過病人了？該患者網路中的接受度如何？近期是否有計劃將業務拓展到維吉尼亞州以外的地區？當你說你的站點中有三分之一是區域或社區中心時，我的意思是，我假設其中大部分是區域中心。能否再詳細談談隨著我們邁入 2026 年，各個社區對收養的期望？

Sure. Yes. So let me unpack that a little bit. We think about the community strategy on a number of paradigm. The first is the fact that we have in our current network, as you mentioned, sites that are already community and regional hospitals.

當然。是的。讓我稍微解釋一下。我們從多個角度思考社區策略。首先，正如您所提到的，我們目前的網路中已經包含一些社區醫院和區域醫院。

And it's a mix because sometimes a large regional hospital will be servicing a community, and that's what we mean by that group. It's about one-third of the 130 or so space that we currently have. And we see that, that segment of our network is already contributing about past the growth that we see. So it's a very healthy, robust part of our network. It's going to continue to grow and it's going to continue to serve the community at large.

而且情況比較複雜，因為有時一個大型區域醫院會為一個社區提供服務，這就是我們所說的族群。這大約是我們目前擁有的130個左右空間的三分之一。我們看到，我們網路中的這一部分所做出的貢獻已經超過了我們所看到的成長。所以它是我們網路中非常健康、強大的組成部分。它將繼續發展壯大，並將繼續服務於廣大社區。

The second part of the strategy is around engaging community physicians who are referred and we've been doing that over the last many months with our partner, J&J, we have sales teams and medical teams who are engaging fully with the referring network. We're building a lot of good information there for them. We're communicating on the profile we're communicating on the fact that referring earlier is better, and we're gaining traction there as well.

這個策略的第二部分是圍繞著與被轉診的社區醫生進行互動，在過去的幾個月裡，我們一直與我們的合作夥伴強生公司一起開展這項工作，我們的銷售團隊和醫療團隊正在與轉診網絡進行充分的互動。我們正在那裡為他們收集很多有用的信息。我們正在透過個人資料進行宣傳，強調儘早推薦更好，而且我們也正在取得一些成效。

The third leg of the journey, if you will, is then going to the community networks, and you mentioned VOA. So just to answer your question, yes, we have started to treat patients at VOA. The feedback has been positive so far.

如果要說旅程的第三階段，那就是進入社群網絡，你提到了美國之音。所以，回答你的問題，是的，我們已經開始在VOA治療病人了。目前為止，回饋都是正面的。

We're also learning a number of things about just how these community networks will need to be supported throughout their experience of coming online, but there is definitely plans to engage not only with VOA and continue to grow that network but also to engage with other practices throughout the next several months and into 2026.

我們也正在了解這些社群網路在上線過程中需要如何得到支持，但我們確實有計劃不僅與美國之音合作並繼續發展該網絡，而且在接下來的幾個月以及 2026 年裡與其他機構合作。

And when you think about the community-specific practices here, I mean, I guess I'm asking about your ability to dose in settings where your potential competitors absolutely would not be able to dose at least not first, not just referring to academic centers, but folks getting treated in the community where competitors don't have reach. Can you talk about how that will evolve in '26?

當你考慮到社區的具體情況時，我的意思是，我想問的是，你是否有能力在你的潛在競爭對手絕對無法（至少一開始無法）提供服務的環境中提供治療，這不僅指學術中心，也指在競爭對手無法觸及的社區中接受治療的人。您能談談這種情況在 2026 年會如何發展嗎？

Well, I think we're laying the groundwork for having that -- having all that presence in the community, but also to your point, we have about half of our current patients are treated in the outpatient setting. And by virtue of the fact that we have a median onset of the CRS in the clinical studies at seven days.

嗯，我認為我們正在為此奠定基礎——在社區中擁有如此強大的影響力，但正如您所說，我們目前大約有一半的患者是在門診接受治療的。而臨床研究表明，CRS 的中位發病時間為 7 天。

That means that increasingly, practices are comfortable with making sure that physicians can dose patients in the outpatient setting, they can be monitored. And then if they need to be readmitted for one reason or the other, they're able to do that afterwards.

這意味著越來越多的醫療機構能夠確保醫生在門診環境中給予患者用藥，並對其進行監測。如果他們之後因為某些原因需要重新入院，他們也可以這樣做。

And in addition, as we've discussed before, the removal of the REMS is also an important tailwind because it's been enabling patients to have only two weeks of local modeling before they're able to go back home. And then also it removes the driving description of eight weeks, and that's now down to two weeks. So that's another important factor for patients being able to get dosed get infused and then be able to be monitored more close to home and get back with their lives.

此外，正如我們之前討論過的，取消 REMS 也是一個重要的利多因素，因為它使得患者只需接受兩週的局部建模治療即可回家。此外，它還刪除了八週的駕駛描述，現在縮短到了兩週。所以，對病人來說，能夠接受給藥、輸液，然後在離家更近的地方接受監測，並且恢復正常生活，這是另一個重要的因素。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

This is [Dana] on for Yaron. n an amazing quarter. I have a question on the ASH abstracts. I think there were two abstracts from Mayo and Moffitt suggesting that prophylactic dex doesn't seem to reduce the risk of delayed neurotox with CARVYKTI. And given those results, how are you thinking about adjusting your strategy for mitigating delayed neurotox?

這是達娜為亞倫效力。這是一個精彩的季度。我有一個關於ASH摘要的問題。我認為 Mayo 和 Moffitt 的兩篇摘要表明，預防性地塞米松似乎並不能降低 CARVYKTI 治療後遲發性神經毒性的風險。有鑑於這些結果，您打算如何調整策略來減輕遲發性神經毒性？

Are you considering any alternative regimens or thinking about amending any Phase III protocols?

您是否考慮過其他治療方案或修改任何三期臨床試驗方案？

This is Ying. I'll answer this question. So obviously, if you look at both the presentations asset, you see that ALC remains a very predictive marker. However, the dexamethasone prophylaxis may not be sufficient. And in fact, recently, you have seen publications from real-world studies, including the blood paper that was published in August, right?

這是英。我會回答這個問題。所以很明顯，如果你看一下演示資產，你會發現 ALC 仍然是一個非常有預測性的指標。然而，地塞米松預防可能不足以發揮作用。事實上，最近你們也看到了一些來自真實世界研究的出版物，包括 8 月發表的關於血液的論文，對吧？

So we think that the most important factor is you need to treat those patients with high tumor burden with effective bridging regimen. And you will see actually quite a few assets coming out in the ASH next month, that various centers are using different recipes or different regimens.

所以我們認為最重要的因素是，你需要用有效的橋接方案來治療那些腫瘤負荷高的病人。在下個月的 ASH 會議上，您將會看到很多成果，各個中心都在使用不同的配方或不同的治療方案。

But again, all the commonality suggests that you have to use an effective bridging therapy. In fact, one of the PIs from Mayo, right, Dr. Lin recently said at IMS that you have to switch to a different effective regimen if the first one does not work. So the critical factor here is we have to bring the tumor burden down. And once you do that, you will not see adverse events such as neurotox colitis or CRS.

但同樣，所有這些共同點表明，你必須使用有效的過渡療法。事實上，梅奧診所的一位首席研究員，林博士，最近在IMS會議上表示，如果第一種有效的治療方案無效，就必須換用另一種有效的治療方案。所以關鍵在於我們必須降低腫瘤負荷。一旦你這樣做，你就不會看到神經毒性結腸炎或細胞激素釋放症候群等不良事件。

So that is actually a trend we're seeing. Like I said, you will see more real-world data and also more presentations at ASH about this.

所以這確實是我們觀察到的趨勢。正如我所說，在 ASH 大會上，你會看到更多真實世界的數據，也會看到更多相關的演講。

James Shin, DB.

James Shin，DB。

I got a couple on CARTITUDE-10. I see fludarabine is being removed, but is there any change to cyclophosphamide dosing? And assuming this looks, I guess, to Legend standards, will this be somehow added to the label or formally, I guess, approved by the FDA and can be adopted broadly?

我在 CARTITUDE-10 上收到了幾個。我看到氟達拉濱被停用了，那麼環磷酰胺的劑量會有變化嗎？假設這符合 Legend 的標準，那麼它會以某種方式添加到標籤上，或者正式獲得 FDA 批准並被廣泛採用嗎？

James, this is Ying. So you're right. We and our partner, Johnson & Johnson, recently initiated a Phase II study called CARTITUDE-10. And the first cohort would evaluate the fludarabine-free regimen for lymphodepletion. The reason being that we know fludarabine has been established as a neurotox factor here.

詹姆斯，我是英。你說得對。我們和我們的合作夥伴強生公司最近啟動了一項名為 CARTITUDE-10 的 II 期研究。第一批受試者將評估不含氟達拉濱的淋巴清除方案。原因是我們知道氟達拉濱在這裡已被證實具有神經毒性。

So we'd like to see whether we can actually achieve similar level of lymphodepletion without using fludarabine. So that is already up and running. We're enrolling and dosing patients now. Now on your second question, we have to generate the data first. And of course, if the data is positive, we would potentially take that to the FDA to see if that could be included in the label.

因此，我們想看看是否能在不使用氟達拉濱的情況下達到類似的淋巴細胞清除水平。所以它已經上線運行了。我們現在正在招募患者並進行給藥。關於你的第二個問題，我們首先需要產生數據。當然，如果數據是正面的，我們可能會將其提交給 FDA，看看是否可以將其納入標籤中。

But right now, it's premature to say anything about the label inclusion.

但現在談論標籤是否包含在內還為時過早。

Can I ask one more on the primary being MRD? Was that any insight from the FDA? And do you have any insight on MRD becoming formally a surrogate?

我可以再問一個關於主要診斷為 MRD 的問題嗎？這是美國食品藥物管理局（FDA）提供的任何資訊嗎？您對MRD正式成為代理孕母有什麼看法嗎？

Yes. So James, regarding MRD as a potential registrational endpoint, we're continuing our discussion with the FDA. And also, we'd like to see under which setting in which line potentially can margin activity be an endpoint. But you have to stay tuned. And when we have more to say, we'll disclose about that.

是的。所以 James，關於 MRD 作為潛在的註冊終點，我們正在繼續與 FDA 進行討論。此外，我們也想了解在哪條線路的哪種設定下，保證金活動有可能成為終點。但請繼續關注。如果有更多消息，我們會另行公佈。

Justin Zelin, BTIG.

Justin Zelin，BTIG。

I was curious if you could give us an update on outpatient administration, what percentage of patients are you seeing dose in the outpatient setting? And any update on the contribution of revenue from earlier lines versus later lines?

我想了解您關於門診給藥的最新情況，您有多少比例的患者是在門診接受給藥的？關於早期產品線和後期產品線的收入貢獻，是否有任何最新資訊？

Yes. So I think I mentioned this earlier, outpacing based on claims data is about 50% of the patients currently and we continue to expect that will be growing over time. Although as we onboard new sites, sometimes they tend to start with patients in the inpatient.

是的。我想我之前提到過，根據理賠數據，目前約有 50% 的患者超過了預期，我們預計隨著時間的推移，這一比例還會繼續增長。雖然我們在引入新站點時，有時它們往往會從住院病人開始。

So the growth of the site network is also a little bit of a drag on the outpatient overall mix, but those sites that have converted into outpatient are doing so with good success, and it's enabling additional capacity at each site and efficiency.

因此，站點網路的成長也對門診整體組成造成了一定的拖累，但那些已經轉型為門診的站點都取得了良好的成功，並且提高了每個站點的容量和效率。

To answer your second question, we see about 60% of our overall scripts coming from the second through fourth line population. That does continue to grow, albeit a little bit more slowly than we had anticipated, but we see that evolution continue, and in fact, the fastest-growing part of that mix is in the third line.

關於你的第二個問題，我們發現大約 60% 的劇本來自二至四線演員。雖然成長速度比我們預期的要慢一些，但這種成長仍在繼續，事實上，成長最快的部分是第三行。

So what that tells us is that increasingly, there is adoption, there's acceptance and there's enthusiasm for bringing CAR-T and CARVYKTI specifically into the earlier line setting based on the CARTITUDE-4 data.

這告訴我們，根據 CARTITUDE-4 數據，越來越多的人開始採用、接受並熱衷於將 CAR-T 和 CARVYKTI 特別引入早期治療方案中。

Mitchell Kapoor, HC Wainwright.

米切爾·卡普爾，HC·溫賴特。

This is Katie on for Mitchell. Regarding your guidance for profitability by 2026, what milestones and roadblocks are kind of underpinning that? And what should we be keeping an eye on to understand if you're on track to hit that goal?

這是凱蒂替米切爾報道。關於您提出的到 2026 年實現盈利的預期，有哪些里程碑事件和障礙需要克服？那麼，我們應該專注在哪些方面才能知道你是否正朝著目標穩步前進呢？

Yes. Thank you, Katie. Our view on profitability has not changed. We actually expect to have profitability for CARVYKTI this year in 2025 and enterprise-wise or for Legend as a company in 2026. This is underpinned by our significant growth for the [factor] for CARVYKTI, and our management of operating expenses resulting in positive free cash flow in the year of 2026.

是的。謝謝你，凱蒂。我們對獲利能力的看法沒有改變。我們預計 CARVYKTI 將於 2025 年實現盈利，而 Legend 公司將於 2026 年實現盈利。這得益於 CARVYKTI [因子] 的顯著成長，以及我們對營運費用的管理，從而在 2026 年實現了正的自由現金流。

Again, as we've mentioned, we have significant tailwinds in our revenue growth, and this should serve us well for profitability next year.

正如我們之前提到的，我們的收入成長有很大的有利因素，這應該會對我們明年的獲利能力大有裨益。

Ash Verma, UBS.

阿什維爾馬，瑞銀集團。

So just maybe like I'm trying to understand if I mix between the second to fourth line that you commented on third line you said there's a post comment. Can you give us a sense of how much is that? And just secondly, on the Majestic III data, like top line is available now, but just curious how that can start to impact the second line opportunity for you in any way?

所以，我只是想弄明白，如果我把你在第三行評論的第二行到第四行混在一起，你說那裡有一條帖子評論。你能大概說說那是多少嗎？其次，關於 Majestic III 的數據，例如第一線數據現在已經可用，但我很好奇這會以任何方式對您在第二線投資機會產生什麼影響？

Yes. So we wouldn't break down -- we're not going to break down the split between how much is coming from each line. But I think it is important that all of the lines of therapy on an absolute basis are growing. We're getting more and more patients in the second line, more and more patients than third, et cetera, et cetera.

是的。所以，我們不會細分——我們不會細分每條生產線貢獻的金額。但我認為，所有療法的發展壯大都是非常重要的。我們發現二線患者越來越多，三線患者也越來越多，以此類推。

We also happen to be getting more patients in the later lines. That's just by virtue of the demand for CARVYKTI across all lines, and that's why the mix continues to be about a 60-40 split between the earlier lines of CARTITUDE-4 and the CARTITUDE-1 populations.

我們也發現後期就診的患者越來越多。這完全是因為所有產品線對 CARVYKTI 的需求，所以早期 CARTITUDE-4 產品線和 CARTITUDE-1 產品線的比例仍維持在 60-40 左右。

But again, the -- where the growth we're seeing most pronounced is in the third line, and that's because, again, physicians are recognizing that they want to try to get patients with -- into CARVYKTI treatment as quickly as possible post first relapse or perhaps second relapse.

但同樣地，我們看到成長最明顯的是在第三線，這是因為醫生們再次意識到，他們希望讓患者在第一次復發或第二次復發後儘快接受 CARVYKTI 治療。

Ash, I do want to answer a question about Majestic III. First of all, we're really pleased that there could be potentially another regimen for patients in second line with multiple myeloma. And secondly, I want to point out that the commercial opportunity for this addressable market is very large. You're looking at about 80,000 to 100,000 patients in that segment. And thirdly, I think we are targeting potentially a different segment here, right?

Ash，我想回答一個關於 Majestic III 的問題。首先，我們非常高興，對於多發性骨髓瘤二線治療患者來說，可能又多了一種治療方案。其次，我想指出，這個目標市場的商業機會非常大。該細分市場約有 8 萬到 10 萬名患者。第三，我認為我們瞄準的可能是不同的細分市場，對嗎？

Because if you look at CARVYKTI, we want to emphasize that CARVYKTI has unmatched unprecedented survival data and also with durability. It's also a onetime treatment. So there is a certain patient population who really prefer that kind of a convenience, right, brought by a onetime infusion without further need for any other medication for myeloma. So that is how I view this market, and we don't really expect MAJESTIC III. Data will really impact the uptake for CARVYKTI in second line.

因為如果你看看 CARVYKTI，我們想強調的是，CARVYKTI 擁有無與倫比的、前所未有的生存數據，而且具有耐久性。這也是一次性治療。因此，有一部分患者確實更喜歡這種便利，即一次性輸液後無需再服用任何其他治療多發性骨髓瘤的藥物。這就是我對這個市場的看法，我們並不真正期待 MAJESTIC III。數據將對CARVYKTI作為二線治療藥物的接受度產生重大影響。

Clara Dong, Jefferies.

克拉拉‧董，傑富瑞。

This is [Jenna] on for Clara. Could you give us some comments on your strong international growth? Maybe elaborate on -- where are you seeing the strongest demand and uptake now versus where do you see higher growth potential after Tech Lane comes on? And going into '26 and beyond, how do you foresee the Tech Lane capacity impact market share?

這是[Jenna]替Clara上線。您能否談談貴公司強勁的國際成長動能？能否詳細說明一下—目前您認為哪些領域的需求和接受度最高？而Tech Lane上線後，您認為哪些領域更有成長潛力？展望 2026 年及以後，您認為 Tech Lane 的運能會對市佔​​率產生怎樣的影響？

Yes. Outside of the US, which is obviously led by our partner, J&J, there's been strong uptake in Germany, Spain and Belgium, in particular, as well as the other markets that have launched. Many of the European markets to really see the value here of a onetime infusion, the durability that you get with the PFS and OS benefit as truly providing a strong value not only to patients but also to the health system.

是的。在美國以外（顯然是由我們的合作夥伴強生公司主導的），德國、西班牙和比利時等國以及其他已推出產品的市場都獲得了強勁的反響。許多歐洲市場真正看到了一次性輸注的價值，以及 PFS 和 OS 帶來的持久療效，這不僅對患者，而且對醫療系統來說，都真正具有巨大的價值。

So there's a lot of support for using CARVYKTI earlier in the treatment paradigm, and that's encouraging. We continue to advance the launches that we've already had in the 14 markets around the world, which we listed in the presentation. And we're very excited to have Tech Lane now online from a commercial standpoint to enable the supply both between Tech Lane and Obelisc together, we'll be able to meet the capacity demand for the growing European launches.

因此，在治療方案的早期階段使用 CARVYKTI 得到了廣泛的支持，這令人鼓舞。我們將繼續推動已在全球 14 個市場推出的產品，這些市場已在簡報中列出。從商業角度來看，我們非常高興 Tech Lane 現在能夠上線，從而實現 Tech Lane 和 Obelisc 之間的供應，我們將能夠滿足歐洲日益增長的發布需求。

Sean McCutcheon, Raymond James.

Sean McCutcheon，Raymond James。

A couple of quick ones from us. You noted improving out of spec rates. Can you speak to the trend as you see more real-world patients in the earlier line setting and ongoing efforts to push that out of spec lower? And any commentary on what you think is a feasible kind of minimum steady state there?

我們這裡還有幾個簡短的問題。您提到不合格率有所改善。您能否談談隨著越來越多真實的患者採用早期治療方案以及不斷努力將治療方案的適用範圍下限降低這一趨勢？您認為可行的最小穩態是什麼？對此您有什麼看法？

And then secondarily, can you speak to any early impact of loosening REMS requirements through auto CAR-T and whether you're seeing an uptick in referrals for earlier line patients?

其次，您能否談談透過自動 CAR-T 療法放寬 REMS 要求的早期影響，以及您是否看到早期線患者的轉診數量增加？

Yes. There is an abstract at ASH that's reviewing about 3,000 patient records for out of spec. And the out-of-spec rate is somewhere in the 6% to 9% accorded abstract and in fact, it's lower in the earlier lines. So it's very consistent with what we're hearing around earlier is better. is very consistent with the fact that the T cell is stronger in the earlier patients, and that's enabling a better dose and better viability and lower out of spec.

是的。ASH 上有一篇摘要，正在審查約 3,000 份病患記錄，以確定是否存在不符合規範的情況。不合格率在 6% 到 9% 之間，與預期相符，而且實際上，早期生產線的不合格率更低。所以這與我們聽到的「早期治療效果更好」的說法非常一致。這與早期患者的T細胞更強這一事實非常吻合，這使得他們能夠接受更好的劑量、更高的存活率和更低的超標率。

And we'll continue to drive that down over time across all the nodes in the network, and we believe that, that's going to be very competitive with other products on the market. In terms of the REM, it's a little bit early. We're hearing sort of a mix of reactions from sites.

我們將繼續逐步降低網路中所有節點的開銷，我們相信，這將使產品在市場上具有強大的競爭力。就快速動眼睡眠（REM）而言，現在還稍微早了一點。我們從各個網站聽到的反應不一。

One is that this is great news for patients and that it is enabling patients to get back home more quickly. Other sites are taking a little bit more of a wait-and-see approach in saying they're going to decide on a patient-by-patient basis, which patients were able to go back and which patients they want to keep more close to home.

首先，這對患者來說是個好消息，可以讓患者更快回家。其他一些機構則採取了更觀望的態度，表示他們將根據每位患者的具體情況來決定哪些患者可以返回醫院，哪些患者希望留在離家更近的地方接受治療。

But it's going to be a consultation. The bottom line is it's a burden lifted and it's one that is enabling a more robust conversation about the fact that we can extend the benefit and the efficacy we see with CARVYKTI to more and more patients.

但這將是一次磋商。歸根結底，這減輕了我們的負擔，也讓我們能夠更深入地探討這樣一個事實：我們可以將 CARVYKTI 的益處和療效擴展到越來越多的患者。

I show no further questions at this time. I would now like to turn the call back over to Ying for closing remarks.

我目前沒有其他問題。現在我想把電話交還給穎，請她做總結發言。

Thanks, everyone, for joining today's call. As you can see, we had a really strong quarter, and we continue to expect another strong quarter in the fourth quarter, as well as a very strong year in the next year, 2026.

感謝各位參加今天的電話會議。正如你所看到的，我們本季業績非常強勁，我們繼續預計第四季度業績也將強勁，並且預計2026年也將是業績非常強勁的一年。

So I just want to say that we look forward to seeing everyone here at ASH because we and James are very confident about the efficacy of CARVYKTI and in fact, we will publish the data in an oral presentation of some data. That's not including the ASH abstracts. And we strongly believe that the data at ASH will raise the bar even further for efficacy. So we look forward to seeing everyone in Orlando. Thank you.

所以我想說，我們期待在 ASH 大會上見到大家，因為我們和 James 對 CARVYKTI 的療效非常有信心，事實上，我們將以口頭報告的形式公佈一些數據。這還不包括 ASH 會議摘要。我們堅信，ASH 的數據將進一步提高療效標準。我們期待在奧蘭多見到大家。謝謝。

Thank you. That does conclude today's conference call. Thank you for participating, and you may now disconnect.

謝謝。今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接了。