Legend Biotech Corp (LEGN) 2025 Q2 法說會逐字稿

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

女士們、先生們，感謝你們的支持。歡迎參加傳奇生物2025年第二季財報電話會議。（操作員指示）請注意，今天的會議正在錄音。

I would now like to turn your conference over to Caroline Paul, Associate Director of Investor Relations. Please go ahead.

現在，我想將你們的會議交給投資者關係副總監 Caroline Paul。請繼續。

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

早安.我是傳奇生物投資者關係副總監 Caroline Paul。感謝您今天參加我們的電話會議，回顧我們 2025 年第二季的業績。在本次電話會議之前，我們發布了一份新聞稿，宣布了本季的財務表現。您可以在我們的 IR 網站 legendbiotech.com 上找到新聞稿。

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

參加今天電話會議的還有公司執行長黃英 (Ying Huang)、公司 CARVYKTI 總裁艾倫·巴什 (Alan Bash) 和公司臨時首席財務官 Jessie Yeung。準備好發言後，我們將開始問答環節。我們的研發總裁方國偉和首席醫療官 Mythili Koneru 參加了問答環節。

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

In addition, adjusted net income or loss is a non-IFRS metric. This non-IFRS financial measure is in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with IFRS. There are a number of limitations related to the use of these non-IFRS financial measures versus their closest IFRS equivalent. However, we believe that providing information concerning adjusted net income or loss and adjusted net income or loss per share enhances an investors' understanding of our financial performance. We use adjusted net income or loss as a performance metric that guides management and its operation of and planning for the future of the business.

此外，調整後的淨收入或虧損是非國際財務報告準則指標。此非國際財務報告準則財務指標是根據國際財務報告準則所編製的財務績效指標的補充，並不取代或優於該指標。與最接近的 IFRS 財務指標相比，使用這些非 IFRS 財務指標有許多限制。但是，我們相信，提供有關調整後淨收入或損失以及調整後每股淨收入或損失的資訊可以增強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指導管理及其業務營運和未來規劃的績效指標。

We believe that adjusted net income or loss provides a useful measure of our operating performance from period to period. Our press release includes IFRS to non-IFRS reconciliations for these measures.

我們相信，調整後的淨收入或虧損可以有效衡量我們各期間的經營績效。我們的新聞稿包括這些措施的國際財務報告準則與非國際財務報告準則的對帳。

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

說完這些，我現在將電話轉給 Ying。

Hello, everyone. Thank you for joining us today. We had quite an eventful second quarter as we made history with our long-term survival data at ASCO and achieved the most CAR-T sales ever during a single quarter. During the second quarter, CARVYKTI net trade sales were approximately $439 million, which is a 136% increase year over year. We have now treated over 7,500 patients with CARVYKTI, and our launch remains the strongest CAR-T launch to date.

大家好。感謝您今天加入我們。我們經歷了相當多事的第二季度，我們在 ASCO 上創造了長期生存數據的歷史，並實現了單季 CAR-T 銷售額的最高紀錄。第二季度，CARVYKTI 淨貿易銷售額約為 4.39 億美元，年增 136%。目前，我們已經使用 CARVYKTI 治療了超過 7,500 名患者，我們的上市仍然是迄今為止最強勁的 CAR-T 上市。

In the US, more than half of our utilization is now in the earlier line setting. We continue to anticipate achieving operational breakeven for CARVYKTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses.

在美國，我們現在一半以上的利用率都處於早期線路設定中。我們繼續預計，到 2025 年底，CARVYKTI 將實現營運盈虧平衡，到 2026 年，公司整體將實現盈利（不包括未實現的外匯收益或損失）。

On the regulatory front, we're excited about the FDA's decision to remove risk evaluation and mitigation strategies or reps for currently approved BCMA- and CD19-directed autologous CAR-T therapies. As a result of this change, CARVYKTI's FDA label was also updated to reduce monitoring requirements, such as instructing patients to remain within proximity of a healthcare facility for at least two weeks instead of four weeks, and advising patients to avoid driving for at least two weeks following product administration compared to eight weeks previously. We expect this label update to improve the patient experience and enhance access for patients in both the community and academic settings.

在監管方面，我們對 FDA 決定取消目前批准的 BCMA 和 CD19 導向自體 CAR-T 療法的風險評估和緩解策略或代表感到興奮。由於這項變化，CARVYKTI 的 FDA 標籤也進行了更新，以減少監測要求，例如指示患者在至少兩週（而不是四周）內留在醫療機構附近，並建議患者在服用產品後至少兩週內避免駕駛，而之前是八週。我們希望此標籤更新能夠改善患者體驗並增強社區和學術環境中患者的可近性。

On another overwhelmingly positive note, we received a lot of great publicity following our presentations at ASCO and EHA in June. Starting with new data presented at ASCO on our pipeline candidates. In the Phase 1 study, LB1908, our autologous clouding 18.2 targeted CAR-T cell product demonstrated encouraging antitumor activity with manageable safety and tolerability, and CAR-T cell expansion was observed in all patients.

另一個非常積極的消息是，我們在 6 月於 ASCO 和 EHA 進行演講後獲得了大量宣傳。從 ASCO 上展示的有關我們的候選產品的新數據開始。在第 1 階段研究中，我們的自體雲 18.2 靶向 CAR-T 細胞產品 LB1908 表現出令人鼓舞的抗腫瘤活性，具有可控的安全性和耐受性，並且在所有患者中都觀察到 CAR-T 細胞擴增。

Additionally, in the Phase 1 dose escalating study evaluating LB2102, our DLL3 targeting CAR-T candidate, no dose limiting toxicity were reported and the preliminary efficacy signal was observed up to for those levels. As a reminder, we have an exclusive global licensing agreement with Novartis to develop and commercialize LB2102 and other DLL3 targeting CAR-T therapies discovered by Legend.

此外，在評估我們的 DLL3 靶向 CAR-T 候選藥物 LB2102 的 1 期劑量遞增研究中，未報告劑量限制性毒性，並且在這些水平下觀察到初步療效信號。提醒一下，我們與諾華公司簽訂了獨家全球許可協議，以開發和商業化 LB2102 以及傳奇生物發現的其他 DLL3 靶向 CAR-T 療法。

Turning to CARVYKTI. There were two different analysis I'd like to spend some time highlighting from ASCO. First, you'll recall that in the final protocol-specified analysis of CARTITUDE-1, the median PFS was 35 months, and median overall survival has not been reached, which had already established a new benchmark for triple-class exposed patients with relapsed refractory multiple myeloma. Subsequently, at ASCO this year, in an analysis of remission and survival from CARTITUDE-1, 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 without further multiple myeloma treatment. Furthermore, patients with high-risk telegenetics and those with extramedullary plasmacytomas, were equally likely to be progression free.

轉向 CARVYKTI。我想花一些時間重點介紹 ASCO 的兩種不同分析。首先，您會記得，在 CARTITUDE-1 的最終方案指定分析中，中位 PFS 為 35 個月，中位總生存期尚未達到，這已經為接受三類治療的複發難治性多發性骨髓瘤患者設立了新的基準。隨後，在今年的 ASCO 上，對 CARTITUDE-1 的緩解和生存進行分析時發現，三分之一的接受過大量治療的複發/難治性多發性骨髓瘤患者在接受 CARVYKTI 治療後，無需進一步接受多發性骨髓瘤治療，仍可存活五年或更長時間且無進展。此外，具有高風險遠隔遺傳學特徵的患者和患有髓外漿細胞瘤的患者同樣有可能沒有進展。

To put this into context, at our ASCO Investor Event, Dr. Sundar Jagannath noted that some of these patients were deciding between hospice and CAR-T therapy. The median overall survival of five years clearly set a new benchmark in this population. As a result of this groundbreaking data, numerous media outlets publicize these results as well as patient stories. A number of clinicians indicated to us that they have noticed increased patient awareness about CARVYKTI following some of these articles and TV news stories.

為了說明這一點，在我們的 ASCO 投資者活動上，Sundar Jagannath 博士指出，其中一些患者正在決定是接受臨終關懷還是 CAR-T 療法。五年的中位總存活期顯然為這群人設定了新的基準。由於這些突破性的數據，許多媒體都宣傳了這些結果以及患者的故事。許多臨床醫生向我們表示，在閱讀這些文章和電視新聞報導後，他們注意到患者對 CARVYKTI 的認識有所改善。

Second, based on analysis of subgroups in intent to treat population from CARTITUDE-4, CARVYKTI improved progression-free survival and overall survival versus the standard of care in all subgroups including patients with standard and high-risk cytogenetics, EMD and one prior line of therapy and beyond. For example, the median PFS for patients with high-risk strategy next was 37 months, compared to 10 months for the standard of care. These data continue to support a positive benefit versus risk ratio for CARVYKTI in patients with lenalidomide refractory multiple myeloma as early as after first relapse.

其次，基於對 CARTITUDE-4 意向治療人群亞組的分析，CARVYKTI 與所有亞組的標準治療相比，改善了無進展生存期和總體生存期，包括具有標準和高風險細胞遺傳學、EMD 和一線先前治療及其他治療的患者。例如，高風險策略患者的中位 PFS 為 37 個月，而標準治療患者的中位 PFS 為 10 個月。這些數據繼續支持 CARVYKTI 對來那度胺難治性多發性骨髓瘤患者在第一次復發後就具有積極的效益與風險比。

Turning to further improvements in CARVYKTI safety profile. We continue to leverage our learnings on extensive data that's been generated on over 7,500 patients treated with CARVYKTI. We are facilitating best practice sharing on predicting, mitigating, and managing neurologic events, and we continue to highlight new safety data to patients and physicians. Importantly, we do not see a material impact on utilization and expect continued strong performance on CARVYKTI. In a few months -- moments, you'll hear from Alan on how we and our partner, Johnson & Johnson, are trying to bring CARVYKTI to more patients in need of a CAR-T therapy with a demonstrated survival benefit.

轉向進一步改善 CARVYKTI 安全性。我們將繼續利用從 7,500 多名接受 CARVYKTI 治療的患者身上獲得的大量數據來學習。我們正在促進預測、緩解和管理神經系統事件的最佳實踐共享，並繼續向患者和醫生強調新的安全數據。重要的是，我們沒有看到對利用率的重大影響，並預計 CARVYKTI 將繼續表現強勁。幾個月後，您將聽到艾倫講述我們和我們的合作夥伴強生公司如何嘗試將 CARVYKTI 帶給更多需要 CAR-T 療法並具有明顯生存益處的患者。

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

最後要說的是，在我們轉向我們的管道之前，關於 CARVYKTI，我們仍然預計今年將完成 CARTITUDE-6 的招募。我們相信 CARTITUDE-6 和 CARTITUDE-6 是 CARVYKTI 引入前線環境的關鍵。

Looking at long-term growth for Legend in addition to looking towards moving CARVYKTI into the frontline, we remain focused on solidifying our leadership in the field of cell therapy. We're making progress in new indications such as solid tumor programs, as you have seen with the recent ASCO data. Additionally, we remain excited about the new research facility currently being built in Philadelphia, where in vivo delivery will be one of its key focuses, positioning us well to pursue this area of innovation with the right infrastructure and resources. We believe this next-generation approach to off-the-shelf therapy holds a lot of promise for incurable diseases.

著眼於傳奇的長期發展，除了著眼於將 CARVYKTI 推向前線之外，我們仍將致力於鞏固我們在細胞治療領域的領導地位。正如您在最近的 ASCO 數據中看到的那樣，我們在實體瘤計畫等新適應症方面正在取得進展。此外，我們對目前正在費城建設的新研究設施感到興奮，體內遞送將是其重點之一，這使我們能夠利用適當的基礎設施和資源很好地開展這一創新領域。我們相信，這種現成的下一代治療方法對於治療無法治癒的疾病大有裨益。

Our new platform, TaVec, which is showed for T-cell activation vector is being used to target oncology and autoimmune indications. It provides T-cell specificity, activation and safety through mutations in glycoprotein to block transduction of non-T-cell. We've already dosed a few patients in the IIT study for non-Hodgkin's lymphoma, and we're planning for multiple US IND-enabling studies in the future. We're excited to be embarking on this next frontier of cell therapy innovation, and we look forward to providing additional updates as we make progress on this front.

我們的新平台 TaVec 被展示為 T 細胞活化載體，用於治療腫瘤學和自體免疫疾病。它透過糖蛋白突變來阻斷非 T 細胞的轉導，從而提供 T 細胞特異性、活化和安全性。我們已經在非霍奇金淋巴瘤的 IIT 研究中對幾名患者進行了給藥，並且我們計劃在未來進行多項美國 IND 支持研究。我們很高興能夠踏上細胞治療創新的下一個前沿，並期待在這一方面取得進展時提供更多更新。

To sum up, Legend is the largest standard alone cell therapy company with over 7,500 CARVYKTI patients treated as we forge the path to cure. With a cash position of approximately USD1 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 是最大的標準單一細胞治療公司，為超過 7,500 名接受 CARVYKTI 治療的患者提供了治療，並開闢了治癒之路。我們擁有約 10 億美元的現金，正在投資細胞療法領域的核心差異化因素，並繼續專注於提高營運效率，以確保長期持久的成長。

And with that, I'll pass it over to Alan to provide an update on CARVYKTI.

接下來，我將把主題交給艾倫 (Alan)，讓他提供有關 CARVYKTI 的最新資訊。

Thank you, Ying. As Ying mentioned, CARVYKTI is now the highest selling CAR-T therapy in a single quarter. CARVYKTI net trade sales of $439 million during the second quarter surpassed the previous CAR-T industry record of $414 million in sales in a single quarter. And all of this was achieved in just 12 quarters, which is record breaking in the industry.

謝謝你，英。正如 Ying 所提到的，CARVYKTI 現在是單季銷量最高的 CAR-T 療法。CARVYKTI 第二季淨貿易銷售額為 4.39 億美元，超過了先前 CAR-T 產業單季銷售額 4.14 億美元的紀錄。而這一切僅花了12個季度就實現了，創下了產業紀錄。

Diving deeper into our performance this quarter, CARVYKTI net trade sales grew 136% year over year and 19% from the first quarter. Our global growth was driven by continued share gains and capacity expansion. US net trade sales of $358 million grew 114% year over year and 13% quarter over quarter. Quarter over quarter growth in the US was primarily driven by continued strong demand with nearly 60% utilization in earlier line settings.

深入了解本季的業績，CARVYKTI 淨貿易銷售額年增 136%，季增 19%。我們的全球成長得益於持續的市場份額成長和產能擴張。美國淨貿易銷售額為 3.58 億美元，年增 114%，季增 13%。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接近 60%。

Regarding OUS performance, we had sales of $81 million, which is 4 times the amount over the same period a year ago and represents a 59% increase quarter over quarter. Our OUS performance was driven by expansion in Germany, Switzerland, Austria, and Brazil, and we continue to be excited about bringing CARVYKTI to more eligible patients in Spain, Denmark, Sweden, Belgium, Portugal, and the private markets of Israel and the UK where we recently launched.

關於 OUS 業績，我們的銷售額為 8,100 萬美元，是去年同期的 4 倍，較上季成長 59%。我們的 OUS 表現得益於在德國、瑞士、奧地利和巴西的擴張，我們繼續很高興將 CARVYKTI 帶給西班牙、丹麥、瑞典、比利時、葡萄牙以及我們最近推出的以色列和英國私人市場的更多符合條件的患者。

Turning to tailwinds to build upon our CAR-T market leadership in multiple myeloma. As it relates to manufacturing, we expect to receive approval for our physical expansion in Raritan by the end of the year. Our Tech Lane facility also remains on track to initiate commercial production later this year. This is another critical component of our plans for serving patients in Europe to meet the increasing demand.

順風而行，鞏固我們在多發性骨髓瘤 CAR-T 市場的領導地位。就製造而言，我們預計將在今年年底前獲得在拉里坦進行實體擴張的批准。我們的 Tech Lane 工廠也預計在今年稍後開始商業化生產。這是我們為歐洲患者提供日益增長的需求服務計劃的另一個重要組成部分。

The progress we've made in executing our manufacturing plan and investments has enabled us to be among the best-in-class. Our manufacturing success rate remains at 97%, which we believe is the highest in the CAR-T industry, and we are focused on continued reductions in our turnaround time, which stands at 30 days. We believe this turnaround time is more than sufficient based on our conversations with physicians.

我們在執行製造計劃和投資方面取得的進展使我們成為同類企業中最好的。我們的製造成功率維持在 97%，我們相信這是 CAR-T 產業中最高的，我們致力於繼續縮短週轉時間，目前為 30 天。根據我們與醫生的談話，我們認為這個週轉時間已經足夠了。

As we expand manufacturing capacity and enhance our efficiency, we expect to benefit from a number of demand tailwinds as well. First, of course, is the recent unprecedented long-term survival data that we presented at ASCO on CARTITUDE-1.

隨著我們擴大生產能力並提高效率，我們預計也將受益於一系列需求順風。首先當然是我們在 ASCO 上展示的 CARTITUDE-1 的最新前所未有的長期存活數據。

Second is our demonstrated overall survival benefit. The superior efficacy we have compared to other CAR-Ts should be further aided by the recent REMS updates which are an incremental positive for patients receiving CAR-T therapy and their quality of life post CAR-T administration.

第二是我們證明的整體存活益處。與其他 CAR-T 相比，我們的療效更佳，這得益於最近的 REMS 更新，這對於接受 CAR-T 治療的患者及其接受 CAR-T 治療後的生活品質具有積極的促進作用。

Lastly, in the US, we have expanded access to CARVYKTI in the community by continuing to activate more treatment sites. The number of authorized treatment centers have quickly increased since launch. We now have 123 sites across the United States. And outside of the US, we will continue to benefit from the recent launches I mentioned earlier.

最後，在美國，我們透過繼續啟動更多的治療點，擴大了社區獲得 CARVYKTI 的機會。自成立以來，授權治療中心的數量迅速增加。我們目前在美國有 123 個站點。在美國以外，我們將繼續受益於我之前提到的近期發布的產品。

I'd like to expand now on our strategy for second line plus adoption in the US and provide an update on our progress outside the US. First, the opportunity to offer CARVYKTI to the second-line multiple myeloma patients and beyond remains significant. We estimate that there are about 80,000 patients globally in the second to fourth line who could potentially benefit from our treatment. Combined with the fifth line plus opportunity, this represents over 100,000 patients globally.

我現在想詳細說明我們在美國採用二線以上療法的策略，並提供我們在美國以外的進展。首先，向二線多發性骨髓瘤患者及其他患者提供 CARVYKTI 的機會仍然很大。我們估計，全球約有 8 萬名二線至四線患者可能受益於我們的治療。加上第五線機會，這意味著全球有超過 10 萬名患者。

Aside from targeting specific types of relapse refractory patients, who might benefit most from CAR-T based on their prognosis, we have now implemented strategies to engage treaters, referrers, and patients.

除了針對特定類型的復發難治性患者（根據他們的預後，他們可能從 CAR-T 中受益最多）之外，我們現在還實施了吸引治療者、轉診者和患者的策略。

In parallel with educating physicians on CARVYKTI's profile in order to increase referrals to CARVYKTI sites, we are also working to increase patient awareness through advocacy efforts and even direct-to-consumer education efforts. In fact, we know that multiple myeloma patients and their caregivers are highly educated and engaged in their care, which is why we think engaging them directly will be impactful. We recently launched an awareness campaign on multiple digital streaming and social platforms about the benefit versus risks of a onetime infusion of CARVYKTI. We are looking forward to building awareness through this ever-patient campaign.

在向醫生介紹 CARVYKTI 的概況以增加對 CARVYKTI 站點的推薦的同時，我們也致力於透過宣傳活動甚至直接面向消費者的教育活動來提高患者的意識。事實上，我們知道多發性骨髓瘤患者及其護理人員受過高等教育並積極參與患者的護理，因此我們認為直接與他們接觸會產生積極的影響。我們最近在多個數位串流媒體和社交平台上發起了一項宣傳活動，宣傳一次性輸注 CARVYKTI 的益處與風險。我們期待透過這場耐心的活動來提高人們的意識。

While we engage community physicians and patients today, we are also looking ahead to continue to expand treatment into the community as well. Our launch took us from a concentrated set of tertiary care and academic centers to where we are today with an expanded footprint, about a third of which is made up of regional and community hospitals who have become local experts in CAR-T. And as we look to the rest of this year and beyond, we are embarking on bringing CARVYKTI even closer to the community with identifying community practices that can do CAR-T administration. We are pleased to announce that Virginia Oncology Associates, a network of practices serving a large part of the state is one of our first partners in this effort.

如今，我們在與社區醫生和患者接觸的同時，也期待繼續將治療擴展到社區。我們的成立使我們從集中的三級護理和學術中心發展到今天的規模，業務範圍不斷擴大，其中約三分之一由已成為 CAR-T 領域本地專家的地區和社區醫院組成。展望今年剩餘時間及以後，我們正著手讓 CARVYKTI 更加貼近社區，並確定可以進行 CAR-T 管理的社區實踐。我們很高興地宣布，維吉尼亞腫瘤協會（Virginia Oncology Associates）是我們在這項努力中的首批合作夥伴之一，該協會是一個服務於該州大部分地區的實踐網絡。

To sum up, I'm very pleased with our progress to date to reach more patients. Alongside Johnson & Johnson, we have activated 123 treatment sites since launch. And while practices in the community setting cannot be activated overnight, we have multiple strategies in place to make CARVYKTI a more readily available treatment option in the future.

總而言之，我對我們迄今為止在幫助更多患者方面取得的進展感到非常高興。自成立以來，我們與強生公司合作，已啟動 123 個治療點。雖然社區環境中的實踐不可能一夜之間啟動，但我們已經制定了多種策略，使 CARVYKTI 在未來成為更容易獲得的治療選擇。

CARVYKTI has also seen significant international expansion. In 2024, we launched four markets, and we've more than doubled that for 2025, and we are only in August. Our growing footprint in markets outside the US is supported by our manufacturing facility in Obelisc and we will be further supported with the Tech Lane site expected to start commercial production for Europe later this year. Globally, with the help of our partner, Johnson & Johnson, we have activated 213 treatment sites.

CARVYKTI 也實現了顯著的國際擴張。2024 年，我們推出了四個市場，而 2025 年，這一數字將增加一倍以上，而現在才 8 月。我們位於 Obelisc 的製造工廠為我們在美國以外市場的不斷增長提供了支持，而 Tech Lane 工廠預計將於今年稍後開始為歐洲進行商業生產，這將為我們帶來進一步的支持。在全球範圍內，我們在合作夥伴強生公司的幫助下，已經啟動了213個治療點。

The record-breaking pace at which we have moved to expand access and become the highest selling CAR-T therapy in a single quarter with a demonstrated overall survival benefit is a testament to our joint ability to trailblaze in the field of myeloma cell therapy.

我們以創紀錄的速度擴大了治療管道，並成為單季銷量最高的 CAR-T 療法，且具有明顯的整體生存優勢，這證明了我們在骨髓瘤細胞治療領域共同開拓的能力。

Now it's time to take a closer look at the financials, so I will turn the call over to Jessie.

現在是時候仔細看看財務狀況了，所以我會把電話轉給傑西。

Thank you, Alan, and good morning, everyone. During the second quarter, we delivered solid financial results with CARVYKTI, net sales up 136% year over year. Total revenues were $255 million, driven by collaboration revenue growth of 136% year over year. Q2 delivered $125 million net loss, but $10 million in adjusted net income. After excluding items that are not representative of the company's core business, such as $111 million unrealized foreign exchange loss due to our treasury center based in Ireland.

謝謝你，艾倫，大家早安。第二季度，CARVYKTI 取得了穩健的財務業績，淨銷售額年增 136%。總收入為 2.55 億美元，主要得益於合作收入年增 136%。第二季淨虧損 1.25 億美元，但調整後淨收入 1,000 萬美元。排除不代表公司核心業務的項目後，例如由於我們位於愛爾蘭的財務中心而產生的 1.11 億美元未實現外匯損失。

Importantly, our operating loss of $41 million in the same period one year ago was reduced by almost half to an operating loss of $22 million during the second quarter. The 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 second quarter gross margin on net product sales was 57%. As expected, R&D expense on an IFRS basis declined slightly to $98 million or 39% of revenue while SG&A on an IFRS basis grew 23% from the prior year to $81 million in the second quarter or 32% of revenue.

重要的是，我們去年同期的營業虧損為 4,100 萬美元，而第二季的營業虧損幾乎減少了一半，為 2,200 萬美元。經營績效的顯著改善得益於我們的營運效率和嚴格的費用管理。儘管我們繼續投資於強大的產品線並支援二線適應症的推出和我們的製造能力，但我們第二季淨產品銷售的毛利率為 57%。如預期的那樣，以 IFRS 計算的研發費用略有下降，至 9,800 萬美元，佔營收的 39%，而 IFRS 計算的銷售、一般及行政費用較上年同期成長 23%，至第二季的 8,100 萬美元，佔營收的 32%。

Overall, we believe we have been making strides towards positive operating cash flow generation and profitability. Our adjusted diluted earnings per share was $0.03 compared to negative $0.01 for the same period last year.

總體而言，我們相信我們已經在實現正向經營現金流產生和獲利方面取得了長足進步。我們的調整後每股攤薄收益為 0.03 美元，去年同期為負 0.01 美元。

Now turning to capital allocation. We continue to have a strong balance sheet with $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 profitability, which we anticipate in 2026 excluding unrealized foreign exchange gains or losses.

現在轉向資本配置。我們的資產負債表依然強勁，擁有 10 億美元的現金及等價物和定期存款。在為我們的營運和資本支出（包括未來的創新）提供資金時，我們將繼續優先考慮嚴格的費用管理，直到我們實現盈利，我們預計在 2026 年實現盈利（不包括未實現的外匯收益或損失）。

In summary, our second quarter results demonstrate strong commercial execution supported by CARVYKTI's differentiated clinical profile, along with increasing operational efficiency. We are also pleased with our progress towards pioneering like generation cell therapy treatments for intractable and incurable diseases, as we look to maximize our cell therapy platform.

總之，我們的第二季業績表明，在 CARVYKTI 差異化臨床特性的支持下，商業執行力強勁，營運效率也在不斷提高。我們也對我們在針對難治性疾病和無法治癒的疾病的開創性細胞療法治療方面取得的進展感到高興，因為我們希望最大限度地利用我們的細胞療法平台。

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

現在是時候回答你們的提問了。接線員，我們已經準備好回答第一個問題了。

(Operator Instructions) Terence Flynn, Morgan Stanley.

（操作員指示） 特倫斯·弗林，摩根士丹利。

Congrats on the progress. Maybe two for me. I was just wondering if you can give us any update on potential timing of interim readouts from CARTITUDE-5 and CARTITUDE-6 recognizing the importance of these studies to moving into the first line setting. And then on the efforts in the community oncology setting, can you provide us any more details about Virginia Oncology, like why they elected to lean in here and how you think about that as a template maybe some other community oncology centers to follow and what the timeline might be? Thank you.

恭喜你取得進展。對我來說也許有兩個。我只是想知道您是否可以向我們提供有關 CARTITUDE-5 和 CARTITUDE-6 中期讀數的潛在時間安排的任何更新，以認識到這些研究對於進入一線設定的重要性。然後，關於社區腫瘤學方面的努力，您能否向我們提供有關弗吉尼亞腫瘤學的更多詳細信息，例如他們為什麼選擇在這裡開展工作，以及您如何看待它作為模板，也許其他一些社區腫瘤學中心可以效仿，以及時間表可能是怎樣的？謝謝。

Thanks for your question. Regarding the interim readouts, I think we're monitoring the events closely and it's ultimately going to be driven by the events that we see. Obviously, we're in discussions also with the FDA about using MRD as a dual primary end point.

謝謝你的提問。關於中期數據，我認為我們正在密切關注事件發展，最終數據將由我們看到的事件決定。顯然，我們也在與 FDA 討論使用 MRD 作為雙重主要終點。

And we don't have much to say beyond that, that we will continue those discussions and see -- continue to see how the data evolves.

除此之外，我們沒有太多要說的，我們將繼續這些討論，並觀察數據如何發展。

Terence, it's Alan. Yes, our efforts in Virginia Oncology is in fact a template for how we're thinking about the community adoption. As we talked about before, it has the following components. We want to make sure that we are expanding our footprint into the community and regional hospital setting. We want to make sure we're driving referrals from city practices.

特倫斯，我是艾倫。是的，我們在維吉尼亞腫瘤學方面的努力實際上是我們如何考慮社區採用的模板。正如我們之前討論過的，它有以下組成部分。我們希望確保將我們的業務範圍擴展到社區和地區醫院環境。我們希望確保我們能夠從城市實踐中獲得推薦。

And as VOA demonstrated as a key milestone for us, also starting to activate in the network of immuno-oncology practices. VOA is a leader in this space. They previously administered CAR-T, both in lymphoma and the myeloma space. So they're well respected in this area. They're part of the McKesson network, and they were very excited to partner with CARVYKTI.

正如 VOA 所證明的那樣，這對我們來說是一個重要的里程碑，它也開始在免疫腫瘤學實踐網絡中活躍起來。美國之音是這一領域的領導者。他們之前曾對淋巴瘤和骨髓瘤進行 CAR-T 治療。因此他們在這個領域很受尊重。他們是 McKesson 網路的一部分，他們非常高興與 CARVYKTI 合作。

Gena Wang, Barclays.

巴克萊銀行的 Gena Wang。

Also congrats on the strong quarter. So maybe I will follow Terence's question regarding the community expansion effort. So have you seen any percentage of revenue was driven by this effort in '25? If not, when do you see this effort was started to be shown in the revenue?

也祝賀本季業績強勁。因此，也許我會回答 Terence 關於社區擴展工作的問題。那麼，您是否看到 25 年有任何比例的收入是由這項努力推動的？如果沒有，您認為這項努力何時會開始反映在收入上？

And then also related launch questions. Of 123 treated centers -- treatment centers what percentage has outpatient set -- set up? And also for 2Q '25 revenue, what percentage of patients or revenue was from outpatient setting?

然後還有相關的發布問題。在 123 個治療中心中，有多少百分比設有門診？另外，對於 25 年第二季的收入，有多少比例的患者或收入來自門診？

Gena, it's Alan. I'll share a couple of factors here. First of all, 70% of patients come from the community setting. So that's why the community setting and our continued penetration in that space is very important. And as I mentioned, those efforts will include not only expanding the footprint within the community and regional hospitals, driving referrals, but also starting to administer in the community practices. I think it's a little early for us to pin specific numbers on each element or the contribution of each element or any particular site.

吉娜，我是艾倫。我將在這裡分享幾個因素。首先，70%的患者來自社區。所以這就是為什麼社區環境和我們在該領域的持續滲透非常重要。正如我所提到的，這些努力不僅包括擴大社區和地區醫院的影響力、推動轉診，還包括開始在社區實踐中進行管理。我認為現在就確定每個元素的具體數字或每個元素或任何特定站點的貢獻還為時過早。

In terms of outpatient though, I'll also give an update. We continue to see that a little over half of our patients are administered in the outpatient setting. That is both across any of these community sites, as I mentioned, as well as in the academic centers, their ability to use an outpatient setting. And that's important because that frees up capacity from the inpatient constraints and infrastructure constraints and enables us to not only improve the experience for patients, but also improve the experience for the centers.

不過，就門診而言，我也會提供最新消息。我們繼續看到，超過一半的患者是在門診接受治療的。正如我所提到的，這既適用於任何社區場所，也適用於學術中心，它們都具有使用門診環境的能力。這很重要，因為這可以釋放出住院限制和基礎設施限制的容量，使我們不僅能夠改善患者的體驗，而且能夠改善中心的體驗。

The other element that we've talked about before is earlier line treatment. And as we go into the community, we expect to be able to see more patients referred into the academic centers and the authorized treatment centers from the earlier lines of therapy.

我們之前討論過的另一個要素是早期治療。隨著我們走進社區，我們期望能夠看到更多患者從早期的治療管道轉診到學術中心和授權治療中心。

John Miller, Evercore.

約翰·米勒，Evercore。

Congrats on all the progress. Two for me. I would love to hear more about the breakdown of your currently treated patients in these early line settings? I know you talk about the CARTITUDE-4 label from second to fourth line, but what about patients in the second line specifically and the third line specifically where you won't be overlapping at all with competitors. How much of your current revenues are driven by those second and third-line patients specifically?

祝賀你取得的所有進展。對我來說是兩個。我很想聽聽您目前在這些早期治療環境中接受治療的患者的詳細情況？我知道您談到了從第二行到第四行的 CARTITUDE-4 標籤，但對於第二行和第三行的患者俱體來說呢？在這些情況下，您與競爭對手完全不會重疊。您目前的收入有多少是來自二線和三線病患？

And then just one on J&J's bispecific efforts. How do you expect that their next-gen T-cell engagers are going to interact with CARVYKTI eventually when they're competing on the market? And how do you expect J&J to be positioning them relative to cell therapy? Thank you.

接下來我們再來談談強生公司的雙特異性努力。當他們在市場上競爭時，您認為他們的下一代 T 細胞接合劑最終將如何與 CARVYKTI 相互作用？您認為強生公司將如何定位細胞療法？謝謝。

John, we don't plan to break down any more detail around the various lines of therapy. But what I can say is, as we said before, that nearly 60% of our orders are coming from the second through fourth line population. So those are the earlier line patients who we feel will provide us a significant advantage to any potential competitor who comes in, in later lines and that's from our ordering system. So that is self-reported data from physicians, and we're very excited about that growing each quarter and continuing to grow throughout the course of this year and certainly before any competitor launches.

約翰，我們不打算進一步詳細討論各種治療方法。但我可以說的是，正如我們之前所說，我們近 60% 的訂單來自二線至四線人口。因此，我們認為，這些較早排隊的患者將為我們提供顯著的優勢，使我們免受任何進入後期排隊的潛在競爭對手的競爭，而這正是來自我們的訂購系統。這是來自醫生的自我報告數據，我們對每個季度的成長感到非常興奮，並且在今年全年繼續成長，當然在任何競爭對手推出之前也是如此。

In terms of the bispecifics, I think we've seen that CAR-T is very well regarded as not only a treatment because of its onetime infusion, but also the overall survival benefit and the durability that CAR-T and specifically CARVYKTI can provide. And so in terms of positioning, right now, CARVYKTI is really owning that second through fourth line opportunity within the J&J portfolio. This is an opportunity for us to really solidify our position with patients for whom they've already had one relapse. They're looking for overall survival. They're looking for long-term durability and J&J and Legend are combined, very committed to this positioning for CARVYKTI.

就雙特異性抗體而言，我認為我們已經看到 CAR-T 不僅因為其一次性輸注而被視為一種治療方法，而且 CAR-T 和特別是 CARVYKTI 還可以提供整體生存益處和持久性。因此，就定位而言，目前，CARVYKTI 確實擁有強生產品組合中第二至第四線的機會。對我們來說，這是一個真正鞏固我們在復發的患者中的地位的機會。他們正在尋求整體生存。他們尋求的是長期耐用性，強生和 Legend 合併後非常致力於 CARVYKTI 的這一定位。

And also John, this is Ying. I want to add to Alan's comments. If you notice that you can find naturally trials on clinicaltrials.gov, where our partner, J&J, is actually combining and/or sequencing CARVYKTI with some of devices in their portfolio. So you will see the direction of that development. It is too early and premature to comment on strategy on developing the prices of it because right now it's still at a very stage in Phase 1 stage.

還有約翰，這是英。我想補充一下艾倫的評論。如果您注意到，您可以在 clinicaltrials.gov 上找到自然試驗，我們的合作夥伴 J&J 實際上正在將 CARVYKTI 與其產品組合中的某些設備進行結合和/或排序。所以你會看到這種發展的方向。現在評論其價格製定策略還為時過早，因為目前它仍處於第一階段。

Although we cannot disclose the breakdown of second, third, fourth, and fifth line and beyond, and plus some of those are coming from actually insurance claims data. It's not necessarily coming from our own data, but I can tell you if you combine second and third line, those are probably the fastest-growing revenue contributor in the mix of CARVYKTI.

雖然我們不能透露第二、第三、第四、第五行及以後的細目，但其中一些實際上來自保險索賠數據。這不一定來自我們自己的數據，但我可以告訴你，如果將第二線和第三線結合起來，它們可能是 CARVYKTI 組合中成長最快的收入貢獻者。

Also, if you talk to physicians, you will notice that, the large majority, probably 70%, 80% of patients are actually receiving a bridging therapy. So sometimes if you look at insurance claim, you will see a second-line patient who comes in and then received a bridging therapy for one or two cycle would actually be classified as a third-line patient. That is another reason why we should look at second and third line not combined.

此外，如果你與醫生交談，你會發現，絕大多數（大概 70%、80%）的患者實際上正在接受橋接療法。因此，有時如果您查看保險索賠，您會看到二線患者進來後接受了一到兩個週期的橋接治療，實際上會被歸類為三線患者。這也是為什麼我們應該將第二行和第三行結合起來看待的另一個原因。

Just one other comment regarding the trispecific from J&J. If the video that was released, a lot of it was in the BCMA naive population, which, as we know, is getting harder and harder to find. And so as we move CARVYKTI into earlier lines of therapy, it's really going to be in other BCMA products approved, it's going to be hard to find that patient population.

關於強生公司的三特異性抗體還有一則評論。如果發布的影片是 BCMA 天真人群拍攝的，那麼很多都是這樣的，但正如我們所知，這種人群越來越難找到了。因此，當我們將 CARVYKTI 轉移到早期治療線時，它實際上將出現在其他 BCMA 批准的產品中，找到這樣的患者群體將會很困難。

Jessica Fye, JPMorgan.

潔西卡費伊（Jessica Fye），摩根大通。

This is Adam on for Jess. I really had two. Can you comment on the recent blood paper as it relates to real-world rates of neurotox with CARVYKTI?

這是亞當為傑西表演的。我確實有兩個。您能否評論一下最近的血液論文，因為它與 CARVYKTI 的實際神經毒性發生率有關？

And my second one, what is your latest perspective on CARVYKTI's penetration into the CARTITUDE-4 indication of second to fourth line?

我的第二個問題是，您對 CARVYKTI 滲透到 CARTITUDE-4 第二至第四行適應症的最新看法是什麼？

Sure. Regarding the blood paper that you're referring to by Dr. (inaudible) in that large data that 98 patients were treated with cilta-cel at 20 various centers. And in those patients that used TALVEY as bridging therapy to a single infusion of CARVYKTI, it was noted that there were no events of parkinsonism or Guillain-Barré syndrome. And there are only two reports of (technical difficulty) policies, both of which resolved.

當然。關於您所提到的血液試紙，博士（聽不清楚）在大量數據中，有 98 名患者在 20 個不同的中心接受了 cilta-cel 治療。並且，在那些使用 TALVEY 作為 CARVYKTI 單次輸注的過渡療法的患者中，沒有出現帕金森氏症或格林-巴利綜合症的事件。且只有兩份（技術難題）政策報告，都已解決。

It really highlights the opportunity of an improved safety profile with strong bridging like with TALVEY. And if you compare that to the real-world data of about 2% decreases to 0% in the large data set.

它確實凸顯了透過像 TALVEY 這樣的強大橋接來提高安全性的機會。如果將其與現實世界的數據進行比較，則大型數據集中約 2% 會下降到 0%。

In terms of the CARTITUDE-4 population, second through fourth line, again, as we said before, this is our main growth driver. We're focused on driving earlier lines of therapy. And as we said before, nearly 60% of our sales are coming from that population. But I would say, again, as we talked about before, this is a population that is about 80,000 patients worldwide. And so you can just based on -- on the numbers of patients that we treated to date, we still have a lot of opportunity in this space, a very large opportunity for us to continue to capture in the second through fourth line population globally.

就 CARTITUDE-4 族群而言，第二至第四線，正如我們之前所說，這是我們的主要成長動力。我們專注於推動早期治療。正如我們之前所說，我們近 60% 的銷售額來自該族群。但我想再次強調，正如我們之前所討論的，全球範圍內大約有 80,000 名患者。因此，僅根據我們迄今為止治療的患者數量，我們就可以看出，我們在這個領域仍然有很多機會，這是一個非常大的機會，我們可以繼續在全球範圍內吸引第二到第四線人群。

Adam. Thanks for this question on blood paper. We actually think it's a very important paper here because if you compare this data set from the competing dataset, you're looking at a total of 134 patients receiving TALVEY out of which 119 per city to get a CAR-T and then 98 patients received commercial CARVYKTI. These are from multicenters, right, 20 centers, including 18 in the US and 2 in Germany.

亞當。感謝您對血紙的提問。我們實際上認為這是一篇非常重要的論文，因為如果你將這個數據集與競爭數據集進行比較，你會看到總共有 134 名患者接受 TALVEY，其中每個城市有 119 名患者接受 CAR-T 治療，然後 98 名患者接受商業 CARVYKTI。這些來自多中心，對，20 個中心，其中美國 18 個，德國 2 個。

If you also look at patient baseline, they received the medium five prime lines of therapy, 44% had high-risk telegenetics, 41% had EMD actual measured disease. So 85% of those patients would not have qualified for CARTITUDE-1. And yet still, if you look at the safety profile, we did not see any delayed neurotox such as parkinsonism or GBS. There were only two cases of mild cranial nerve policy and both resolved.

如果您也查看患者基線，他們接受了中等五種主要療法，其中 44％ 患有高風險遠端遺傳學，41％ 患有 EMD 實際測量疾病。因此，85% 的患者不符合 CARTITUDE-1 的資格。然而，如果你看一下安全性概況，我們並沒有發現任何延遲性神經毒性，例如帕金森氏症或格林巴利症候群。僅有兩例輕度腦神經損傷病例，均已痊癒。

So if you compare this data sense, when you're competing dataset of about 120 patients, I would argue it's a very similar denominator here. And also, if you look at the neurotox, very similar as well. I think that is a very well-documented study, like I said, peer reviewed on blood journal. So this gives you a sense of the real world safety.

因此，如果您比較這個數據意義，當您競爭大約 120 名患者的數據集時，我會認為這是一個非常相似的分母。而且，如果你觀察一下神經毒素，它們也非常相似。我認為這是一項有據可查的研究，就像我說的，在《血液》雜誌上經過同行評審。這能讓你感受到現實世界的安全。

Konstantinos Biliouris, BMO Capital Markets.

蒙特利爾銀行資本市場的 Konstantinos Biliouris。

Congrats on the progress. We would love to hear your thoughts around the recent efficacy data from a competitor and specifically the 18-month PFS, which appears to be similar to CARTITUDE-1. Any thoughts around that, although the follow-up is sorted than what you have presented. And how do you think -- are you thinking about the positioning of CARVYKTI moving forward? Thank you.

恭喜你取得進展。我們很想聽聽您對競爭對手的最新療效數據的看法，特別是 18 個月的 PFS，它似乎與 CARTITUDE-1 相似。儘管後續工作比您提出的要有條理，但您對此還有什麼想法嗎？您認為 CARVYKTI 未來的定位如何？謝謝。

Thanks for your question. I'd like to stress that CARVYKTI is really the best-in-class BCMA CAR-T. We've treated over 7,500 patients, as you've just heard earlier. And it's really demonstrated an overall survival benefit in this early second to fourth line patient population as reported into the CARTITUDE-4 study. So in addition to that, the CARTITUDE-1 data from the ASCO has shown that with the onetime infusion of CARVYKTI, a third of the patients in this very heavily pretreated population actually didn't progress after five years.

謝謝你的提問。我想強調的是，CARVYKTI 確實是同類最佳的 BCMA CAR-T。正如您之前所聽到的，我們已經治療了超過 7,500 名患者。CARTITUDE-4 研究報告顯示，它確實為早期二線至四線患者群體帶來了整體存活益處。除此之外，來自 ASCO 的 CARTITUDE-1 數據顯示，透過一次性輸注 CARVYKTI，該群體中三分之一接受過大量預先治療的患者在五年後病情實際上沒有出現進展。

This is unprecedented data and shows the long follow-up that we have with patients treated with CARVYKTI. I would argue that the patient population (inaudible) study that you're referring to is really fundamentally a different patient population. In particular, the prior lines of therapy, the CARTITUDE-1 study is a much more heavily pretreated patient population. And as you have mentioned, their data is immature and still evolving with not sufficient follow-up. So based on some other conversations we've had with physicians, they're really wondering how these patients have done when they reach the 18th month PFS, how many of them have actually reached that point.

這是前所未有的數據，顯示我們對接受 CARVYKTI 治療的患者進行了長期追蹤。我認為您所指的患者群體（聽不清楚）研究實際上從根本上來說是不同的患者群體。特別是，與先前的療法相比，CARTITUDE-1 研究針對的是接受過更多預先治療的患者群體。正如您所說，他們的數據還不成熟，仍在不斷發展，後續跟進不足。因此，根據我們與醫生進行的其他一些對話，他們真正想知道這些患者在達到第 18 個月 PFS 時的表現如何，其中有多少人真正達到了這一點。

And without the evidence of the Kaplan-Meier curve, which actually the CARVYKTI we had reported around the 18-month timeframe, it's really hard to tell the [RSLC study] how these patients did overall. That's why I think it's important that we see that data and stress the fact that CARVYKTI really key differentiated and have very durable responses with the large amount of data sets that we've provided to date.

而且，如果沒有 Kaplan-Meier 曲線的證據（實際上是我們在 18 個月左右的時間範圍內報告的 CARVYKTI），就很難告訴 [RSLC 研究] 這些患者的整體表現如何。這就是為什麼我認為查看這些數據並強調 CARVYKTI 確實具有關鍵的差異性並且對我們迄今為止提供的大量數據集具有非常持久的響應非常重要。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Congrats on the quarter. Mythili, you noted on the call that you're on track to finish enrolling CARTITUDE-6 this year. This sees incrementally pushed out versus mid-2025 previously to any reason that rule might be progressing a little more slowly than expected. And does this mean that we're still going to see an impact on Q3 revenues from slots being diverted to CARTITUDE-6? And overall, does that change your expectations that previously on accelerating growth for CARVYKTI in second half of the year versus first half? Thanks so much.

恭喜本季取得佳績。Mythili，您在電話中提到，您預計今年將完成 CARTITUDE-6 的註冊。與 2025 年中期相比，這一時間將逐步推遲，原因是規則的進展可能比預期的要慢一些。這是否意味著我們仍會看到時段轉移到 CARTITUDE-6 對第三季營收產生影響？總體而言，這是否會改變您先前對 CARVYKTI 下半年相對於上半年加速成長的期望？非常感謝。

Our enrollment in CARTITUDE-6 has been progressing quite speedily. In fact, we've completed enrollment (technical difficulty) totally except for continuing to complete in Japan, which is the last country. So we're very excited about the fact that physicians were enrolling on the study, and it shows the excitement of this patient population with CARVYKTI.

我們在 CARTITUDE-6 的註冊進展非常迅速。事實上，除了最後一個國家日本需要繼續完成以外，其他的招生（技術難度）都已經全部完成了。因此，我們對醫生參與這項研究感到非常興奮，這也顯示了患者群體對 CARVYKTI 的興奮之情。

And just to add in terms of your second part of your question, we're very confident in our ability to continue to drive capacity expansion in the second half of this year. Novartis continues to ramp throughout the year. The tech line clinical approval is taking on those patient slots and enabling more commercial capacity across the network as well as we continue to get efficiencies from our network in terms of out of step rates, improved turnaround time and better manufacturing success rates across the network.

關於您問題的第二部分，我再補充一下，我們對今年下半年繼續推動產能擴張的能力非常有信心。諾華全年持續保持成長動能。技術線臨床批准正在承擔這些患者名額，並在整個網路中實現更多的商業容量，同時我們繼續從我們的網路中獲得效率，包括失步率、縮短週轉時間和提高整個網路的製造成功率。

And as we mentioned before, in the second half of this year, we anticipate the physical expansion for Raritan as well as the commercial approval for Tech Lane.

正如我們之前提到的，今年下半年，我們預計 Raritan 將實現實體擴張，Tech Lane 將獲得商業批准。

And (inaudible), maybe I'll just add that if you recall for the CARTITUDE-1 trial for that indication, we actually enrolled also very small, less than 10 patients cohort, just specifically for the Japanese approval because that's a requirement from PMDA. So we're doing the same for CARTITUDE-6. But like you just heard from our Chief Medical Officer that we have already completed global enrollment for CARTITUDE-6.

而且（聽不清楚），也許我只想補充一點，如果您還記得針對該適應症的 CARTITUDE-1 試驗，我們實際上招募的患者數量也非常少，不到 10 名患者，這只是為了獲得日本的批准，因為這是 PMDA 的要求。因此，我們對 CARTITUDE-6 也做了同樣的事情。但正如您剛剛從我們的首席醫療官那裡聽到的那樣，我們已經完成了 CARTITUDE-6 的全球招募。

Kelly Shi, Jefferies.

Kelly Shi，傑富瑞集團。

Congrats on another strong quarter. Curious as CARVYKTI has traded now over 7,000 patients, also follow-up on your commentaries on the overall safety profile, including delayed neurotox. Curious, any noticeable difference that has been observed in earlier line patients versus late line? If so, what are the factors that drive the difference?

恭喜您又一個季度表現強勁。令人好奇的是，CARVYKTI 目前已服務超過 7,000 名患者，同時關注您對整體安全性概況（包括延遲神經毒性）的評論。好奇的是，早期患者和晚期患者之間有觀察到任何明顯的差異嗎？如果是的話，造成這種差異的因素是什麼？

Thank you for your question. As we've shown from the CARTITUDE-1 to CARTITUDE-4 data, the delayed neurologic event has decreased, particularly the parkinsonism from 6% to 1% in CARTITUDE-4. So we do believe that earlier line treatment does improve the safety profile quite significantly. And part of that success is the strong bridging therapy that is provided to these patients, and these patients just have more options for good bridging therapy in the earlier lines.

感謝您的提問。正如我們從 CARTITUDE-1 到 CARTITUDE-4 數據所顯示的那樣，延遲神經系統事件有所減少，尤其是帕金森氏症在 CARTITUDE-4 中從 6% 下降到 1%。因此我們確實相信早期治療確實可以顯著提高安全性。而成功的部分原因在於為這些患者提供了強有力的橋接治療，這些患者在早期治療中擁有更多良好橋接治療的選擇。

As we discussed earlier in the call, the blood paper by Dr. (inaudible) shows that in a large data set that there was no evidence of parkinsonism, further showing the importance of having good bridging therapy to decrease the neurologic events, but also improve the efficacy profile ultimately. Both of these things, I think, will be really important.

正如我們在電話會議早些時候所討論的那樣，（聽不清楚）博士的血液論文表明，在大量數據中沒有帕金森氏症的證據，這進一步表明了良好的橋接療法對減少神經系統事件的重要性，但最終也能提高療效。我認為這兩件事都非常重要。

I think as we continue the mitigation strategies that we put in place are important and treating physicians are using them, and they continue to show improvement in these safety events.

我認為，隨著我們繼續實施緩解策略，我們實施的緩解策略非常重要，治療醫生正在使用它們，並且他們在這些安全事件中繼續表現出改善。

Kelly, I'll just add a little color on what we're seeing from physicians and hearing from the field. The earlier the patients are referred in and treated the better experience overall. The T-cells were fitter, so that means that we have lower out of stack. We have better efficacy. We also, by virtue of what [My] outlined.

凱利，我只是想稍微補充一下我們從醫生那裡看到的情況和從現場聽到的情況。患者越早轉診和治療，整體體驗就越好。T 細胞更適合，這意味著我們的堆疊溢出更少。我們的功效更好。我們也按照[我的]所概述的。

Also, we have lower rates of any of the rare but serious side effects. So we are in a situation where everything is better when you treat earlier, and that message is very much resonating. That's what the thought leaders are talking about from the podium get your patients in earlier and you get the benefit of CAR-T earlier in the treatment paradigm.

此外，我們出現任何罕見但嚴重的副作用的機率也較低。因此，我們現在的情況是，越早治療，一切都會越好，這個訊息非常具有共鳴。這就是思想領袖在講台上談論的內容，讓您的患者儘早接受治療，您就可以在治療模式中儘早獲得 CAR-T 的益處。

And Kelly, this is Ying. Maybe I'll just add to the last point, which is everyone follows the FDA AR database. Again, if you look at the overall incidents, it's increasing, but that's because we're treating more than 7,500 patients. However, if you do the math using the denominator, numerator, we just provided you will see. In fact, I've seen a few sell-side reports saying that the percentage incidence rates is actually coming down in terms of delay neurotoxicities.

凱莉，這是英。也許我只想補充最後一點，那就是每個人都遵循 FDA AR 資料庫。再說一次，如果你看一下總體事件，你會發現它正在增加，但這是因為我們正在治療超過 7,500 名患者。但是，如果您使用我們剛剛提供的分母、分子進行計算，您就會明白。事實上，我看到一些賣方報告稱，延遲神經毒性的發生率實際上正在下降。

Leonid Timashev, RBC.

列昂尼德·蒂馬舍夫（RBC）。

I wanted to ask on the -- where demand is going to be coming from in the future. I guess in the past, you've talked about your ability to titrate demand. So I'm thinking how are you guys thinking about 2026, specifically where the supply curve is going to be relative to the demand curve. And I'm curious if you can speak to that maybe on a geography basis, I guess, the US and EU separately.

我想問的是──未來的需求將來自哪裡。我想，過去您曾談論過您滴定需求的能力。所以我想知道你們對 2026 年有什麼看法，特別是供給曲線相對於需求曲線的位置。我很好奇您是否可以從地理角度來談談這個問題，我想，分別談談美國和歐盟。

Just given that CARTITUDE-1 have done well in Europe? And should we be expecting more growth coming out of Europe in 2026? And ultimately approach relative parity with the US I guess just how are you thinking about the relative position of the supply and demand curves for US versus EU? Thanks.

只因為 CARTITUDE-1 在歐洲表現良好？我們是否應該期待 2026 年歐洲將實現更多成長？並最終接近與美國的相對平價我猜你是如何看待美國與歐盟的供需曲線的相對位置的？謝謝。

We will be driving both supply and demand simultaneously. They don't grow necessarily on a linear fashion each, but as both grow, we'll be able to support the market with supply. And in terms of the breakdown in terms of geography, you saw in this quarter, increasing contribution from Europe with the 11 markets outside of the US now launched we anticipate that, that will continue to grow over 2026 and beyond. Additional major markets are planned for 2026. And so ex US contribution will continue to become an increasing and meaningful component of the CARVYKTI sales.

我們將同時推動供給和需求。它們不一定都以線性方式成長，但隨著兩者的成長，我們將能夠透過供應來支持市場。從地理分佈來看，本季度您會看到，隨著美國以外 11 個市場的推出，歐洲的貢獻不斷增加，我們預計，這一數字將在 2026 年及以後繼續增長。計劃於 2026 年開拓更多主要市場。因此，美國以外的貢獻將繼續成為 CARVYKTI 銷售額中不斷增長且有意義的組成部分。

And in terms of demand, just to provide a little bit more detail on some of the demand dynamics within the US. We talked about it in the opening remarks, but the ASCO data and the recognition of the overall survival benefit and the long-term survival is something that's going to continue to grow in terms of awareness. And that will translate into not only driving referrals, but also increasing utilization in the earlier lines.

就需求而言，我只是想提供一些更多關於美國國內需求動態的細節。我們在開幕詞中談到了這一點，但 ASCO 數據以及對整體生存益處和長期生存的認可在認識方面將繼續增長。這不僅可以帶來推薦，還可以提高早期產品的使用率。

We also talked about the fact that the REMS removal will be an important component of improving the patient experience. Patients can then be treated in an authorized treatment facility, but then monitored act closer to home, as you heard from Ying, lowered number of weeks in terms of monitoring, fewer number of weeks in terms of the driving restrictions. These things really do matter to patients and their family and caregivers when they're trying to get back into a normal functioning life.

我們也討論了 REMS 移除將成為改善患者體驗的重要組成部分。然後，患者可以在授權的治療機構接受治療，但隨後在家附近進行監測，正如您從 Ying 那裡聽到的，監測的周數減少了，駕駛限制的周數減少了。當患者、他們的家人和照護人員試圖恢復正常生活時，這些事情確實很重要。

So you think about the REMS removal, you think about the overall survival, the ASCO data. And then as we talked about as part of the opening remarks, we've also started to directly engage patients. So this is our DTC effort in a very targeted way, recognizing the fact that myeloma patients and their caregivers lot to hear about CAR-T. They want to learn about CAR-T. They want to be able to have the conversation with their physicians, and that's what we started to do.

因此，您考慮 REMS 移除，考慮整體存活率、ASCO 數據。然後，正如我們在開幕詞中談到的那樣，我們也開始直接與患者接觸。因此，這是我們非常有針對性的 DTC 努力，認識到骨髓瘤患者及其照護者很想了解 CAR-T。他們想了解CAR-T。他們希望能夠與醫生交談，而這就是我們開始做的事情。

So I expect the demand to come from many of those drivers.

因此我預計這項需求將來自許多駕駛者。

James Shin, DB.

詹姆斯·辛，DB。

Appreciate DOA coming online, but what does the partnership should bring to Legend and I guess, broader question is, what percentage of the smaller community practices like VOA are still pending CARVYKTI slots? Secondly is the biggest driver for community adoption getting a lighter version of fact accreditation?

感謝 DOA 上線，但這次合作能為 Legend 帶來什麼？我想，更廣泛的問題是，有多少比例的像 VOA 這樣的小型社群實踐仍在等待 CARVYKTI 的席位？其次，推動社群採用的最大動力是否是獲得更輕鬆版本的事實認證？

We're in the very early stages of having more penetration in the network practices like VOA. So VOA is the first key milestone for us. But as I mentioned, it's the first one in the ones that are planned with J&J and Legend. In terms of fact accreditation, there are several efforts underway both industry groups as well as legislation at the state level to lift the requirement for (inaudible) accreditation. So we want to make sure that authorized treatment centers for cell therapy and for BCMA CAR-T are of course, qualify to do so experts in that area, but not necessarily facing all the significant burdens required with fact accreditation.

我們正處於進一步滲透美國之音等網路實踐的早期階段。因此，美國之音對我們來說是第一個重要的里程碑。但正如我所提到的，這是強生和傳奇公司計劃合作的第一個項目。在事實認證方面，行業團體和州級的立法都在做出多項努力，以取消（聽不清楚）認證的要求。因此，我們希望確保授權的細胞療法和 BCMA CAR-T 治療中心當然有資格成為該領域的專家，但不一定面臨事實認證所需的所有重大負擔。

So there are multiple efforts as you mentioned, to provide some sort of either fact, light or create a fact umbrella from an academic center such as U-Penn to other community hospitals that are part of that umbrella.

因此，正如您所提到的，我們做出了多種努力，從賓大等學術中心向屬於該保護傘的其他社區醫院提供某種事實、啟示或創建事實保護傘。

So again, these are all efforts that will continue to bring CAR-T closer to patients, patients don't want to have to travel into the cities or the major centers for their treatment. And so this enables them to get CAR-T closer to home.

所以，這些努力都是為了讓 CAR-T 更貼近患者，患者不想為了接受治療而前往城市或主要中心。因此，這使得他們能夠讓 CAR-T 更接近本土。

And James, just to supplement what Alan just commented. In fact, Texas is the first state in the US that actually passed a State Legislature recently that in the state of Texas, there's no longer a requirement for fact accreditation for reimbursement by insurance carriers. And we do foresee that more and more states will follows it.

詹姆斯，我只是想補充艾倫剛才的評論。事實上，德州是美國第一個最近通過州立法的州，該州不再要求保險公司對報銷進行事實認證。我們確實預見到會有越來越多的國家效法。

Mitchell Kapoor, H.C. Wainright.

米切爾·卡普爾、H.C. 溫賴特。

Have to -- the first one, could you just talk about since we're halfway through the third quarter at this point about now? Can you talk about the important CARVYKTI trends that you're seeing since the end of June that may show up in the third quarter numbers?

一定——第一個問題，您能談談嗎，因為現在已經到了第三季的一半了？您能否談談自 6 月底以來看到的可能在第三季數據中體現的重要 CARVYKTI 趨勢？

And then second, on geography and mix. Could you talk about the ex-US mix trend? And if the 30% US EU pricing delta is likely to hold as access broadens? Thank you.

其次，關於地理和混合。您能談談美國以外的混合趨勢嗎？隨著市場准入的擴大，美國與歐盟 30% 的定價差異是否可能維持下去？謝謝。

Our demand trends are strong. We're very comfortable with where things are headed for the rest of this year.

我們的需求趨勢強勁。我們對今年剩餘時間的情況發展非常滿意。

In terms of the mix, as I said before, we believe that the launches in Europe will continue to provide incremental demand, out of Germany is the largest of the markets ex-US and that is continuing to grow very nicely, and we continue to see that Europe will be a meaningful and increasing contribution to the overall sales picture for CARVYKTI.

就產品組合而言，正如我之前所說，我們相信在歐洲推出的產品將繼續提供增量需求，德國是美國以外最大的市場，並且正在繼續保持良好的成長勢頭，我們繼續看到歐洲將對 CARVYKTI 的整體銷售狀況做出有意義且不斷增長的貢獻。

And unfortunately, we cannot comment on pricing as you can understand. We believe that CARVYKTI offers a very, very strong health economic benefit based on the survival and also the PFS benefits we have seen. In fact, if you follow last month's ODAC held by FDA to evaluate brand rep from GSK. I think one doctor, one KOL, Dr. Paul Richardson from Dana-Farber and Harvard Medical School actually pointed out in one of the slides that so far in the second-line setting, there's only one trial and one drug that proves survival benefit significantly over standard of care, and that is CARVYKTI in CARTITUDE-4. So we're very well positioned with all these benefits.

不幸的是，正如您所理解的那樣，我們無法對定價發表評論。我們相信，根據我們所見的生存率和 PFS 益處，CARVYKTI 提供了非常非常強大的健康經濟效益。事實上，如果你關注上個月 FDA 舉辦的 ODAC 來評估 GSK 的品牌聲譽。我認為一位醫生，一位關鍵意見領袖，來自丹娜法伯癌症研究所和哈佛醫學院的保羅·理查森博士實際上在其中一張幻燈片中指出，到目前為止，在二線治療中，只有一項試驗和一種藥物證明其生存獲益顯著超過標準治療，那就是 CARTITUDE-4 中的 CARVYKTI。因此，我們擁有所有這些優勢，處於非常有利的地位。

Okay. Yeah. More specifically on the first question, is there anything since the end of June that you guys are seeing that is different than what we've heard on the call so far that may be a trend in Q2?

好的。是的。更具體地說，關於第一個問題，自 6 月底以來，你們看到的東西與我們迄今為止在電話會議上聽到的有什麼不同，這可能是第二季的趨勢嗎？

The only thing I'll add is, anecdotally, and Ying alluded to this earlier, since the ASCO presentation, we've heard more and more patients coming in and actually either holding up one of the local newspaper articles or the New York Times article or having heard about the data, and it's reaching patients, it started to have those conversations with physicians. We heard that from the physicians themselves that that's what patients are saying. So anecdotally, this is creating a lot of buzz and excitement both among the prescribing community. If you go to a medical conference, and there was one this past weekend, I think you'll see physicians start their talk by showing the New York Times headlines from ASCO.

我唯一要補充的是，根據軼事，Ying 之前也提到過這一點，自從 ASCO 報告發布以來，我們聽到越來越多的患者前來就診，他們實際上要么拿著當地報紙文章或紐約時報文章，要么聽說過這些數據，這些數據正在傳達給患者，然後開始與醫生進行這些對話。我們從醫生那裡聽說，這就是病人所說的。因此，有趣的是，這在處方界引起了許多關注和興奮。如果您去參加醫學會議（上週末就有一個），我想您會看到醫生們透過展示紐約時報上來自 ASCO 的頭條新聞來開始他們的演講。

And so again, the anecdotes are showing that there's a lot of interest in the long-term survival benefit that you get from CARVYKTI and we see that is starting to take shape in the marketplace as well.

因此，再次，這些軼事表明，人們對 CARVYKTI 帶來的長期生存益處非常感興趣，我們看到這種趨勢也開始在市場上形成。

Justin Zelin, BTIG.

BTIG 的 Justin Zelin。

Congrats on the strong record-breaking quarter here. So with the $1 billion in cash here, you're approaching profitability, just curious how do you think about approaching reinvestment, with reaching profitability here across manufacturing your pipeline, licensing once you're reaching profitability with your, your vision and your position in the global cell therapy landscape?

恭喜本季業績強勁突破紀錄。因此，有了 10 億美元現金，您就接近盈利了，只是好奇，一旦您的願景和在全球細胞治療領域的地位達到盈利水平，您如何考慮進行再投資，通過製造您的管道、許可來實現盈利？

Thank you for your question. We are committed to reach profitability with $1 million in cash. We are still very disciplined in funding, but we are committed to the next generation of cell therapies treatment for intractable and incurable diseases.

感謝您的提問。我們致力於利用 100 萬美元現金實現盈利。我們在資金方面仍然非常嚴格，但我們致力於針對難治性和無法治癒的疾病的下一代細胞療法治療。

And then just another question that we get is do you expect any material impacts from the recent tariff changes under manufacturing costs or your supply chain and just any impact on how you're mitigating those?

我們收到的另一個問題是，您是否預期最近的關稅變化會對製造成本或供應鏈產生任何重大影響，以及對您如何緩解這些影響會產生什麼影響？

Our understanding is that the details relating to any potential pharma-related tariffs are still being worked out, but because our US products are predominantly made and sourced in the US, at this point, we believe that any potential exposure to tariffs will be immaterial based on our evaluation.

我們的理解是，與任何潛在的製藥相關關稅的細節仍在製定中，但由於我們的美國產品主要在美國製造和採購，因此目前，根據我們的評估，我們認為任何潛在的關稅風險都是無關緊要的。

Ash Verma, UBS.

瑞銀的 Ash Verma。

So just quickly on the ramp of Novartis commercial supply, is that more steady for the remainder of second half? Or should we expect most of that to be reflected in the 3Q sales? And just on -- secondly, on the first-line data generation for CARTITUDE-5, like, do you have line of sight that you can get this data in calendar year 2026. And I know you've previously talked about this CARTITUDE-2 cohort [E&S], which we're still pending. Is that something that we could see later this year?

那麼，諾華商業供應的快速成長，在下半年剩餘時間內是否會更穩定？或者我們是否應該預期其中大部分會反映在第三季的銷售額？其次，關於 CARTITUDE-5 的第一線資料生成，您是否預計可以在 2026 年獲得這些資料。我知道您之前談過這個 CARTITUDE-2 佇列 [E&S]，我們目前仍在等待結果。這是我們今年晚些時候能看到的事情嗎？

On Novartis, we got the approval earlier this year for commercial production, and that has continued to ramp and we expect it to be at full capacity by the end of this year. So that will continue to contribute to our growth over the course of the year.

關於諾華，我們在今年稍早獲得了商業生產的批准，並且一直在不斷增加生產力度，我們預計到今年年底將達到滿載生產。因此，這將繼續促進我們今年的成長。

Regarding your other parts of your question regarding CARTITUDE-5, it will be events driven. So we really need to monitor those closely. So we will not be able to provide more details beyond that.

關於您關於 CARTITUDE-5 的問題的其他部分，它將由事件驅動。所以我們確實需要密切監視這些。因此我們無法提供更多細節。

Regarding the CARTITUDE-2 E&S cohorts looking at frontline patients, we cannot disclose what is being submitted to conferences later this year at this time.

關於關註第一線患者的 CARTITUDE-2 E&S 隊列，我們目前無法透露今年稍後提交給會議的內容。

Thank you. And this does conclude today's question-and-answer session and also concludes today's conference call. Thank you so much for participating, and you may now disconnect.

謝謝。今天的問答環節和電話會議到此結束。非常感謝您的參與，您現在可以斷開連接了。