Legend Biotech Corp (LEGN) 2024 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to Legend Biotech second-quarter 2024 earnings conference call. (Operator instructions) Please be advised that today's conference is being recorded. I would now like to turn the conference over to Jessie Yeung, Vice President of Investor Relations and Finance. Please go ahead.

女士們先生們，謝謝你們的支持。歡迎參加傳奇生物2024年第二季財報電話會議。 （操作員說明）請注意，今天的會議正在錄製中。我現在想把會議交給投資者關係和財務副總裁 Jessie Yeung。請繼續。

Good morning. This is Jessie Yeung, VP of Investor Relations and Finance at Legend Biotech. Thank you for joining our conference call today to review our second quarter of 2024 performance. The second quarter has been an eventful one. We are pleased to report 18.5% sequential growth in capacity sales.

早安.我是傳奇生物科技投資者關係和財務副總裁 Jessie Yeung。感謝您今天參加我們的電話會議，回顧我們 2024 年第二季的業績。第二季是多事之秋。我們很高興地報告產能銷售季增 18.5%。

More important to me, we received label expansion approvals from both FDA and EMA. Lastly, we are most excited about the survival benefit demonstrated by complexity in a secondary analysis of positive four, nothing gives us more choice than helping patients with multiple myeloma live longer.

對我來說更重要的是，我們獲得了 FDA 和 EMA 的標籤擴展批准。最後，我們對陽性四項二次分析的複雜性所證明的生存益處感到最興奮，沒有什麼比幫助多發性骨髓瘤患者延長壽命給我們更多的選擇了。

Joining me on today's call are Ying Huang, the company's Chief Executive Officer, and Lori Macomber number, the company's Chief Financial Officer. Following the prepared remarks, we will open up the call for a Q&A.

參加今天電話會議的還有公司執行長黃英和財務長洛里·麥康伯 (Lori Macomber number)。在準備好的發言之後，我們將開始問答環節。

We have Guowei Fang, Chief Scientific Officer, and Steve Gavel, Head of Commercial Development for the US and Europe, joining the Q&A session.

首席科學官方國偉和美國和歐洲商業開發主管 Steve Gavel 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. Thank you.

在今天的電話會議中，我們將做出前瞻性聲明，這些聲明存在風險和不確定性。這可能導致我們的實際結果與這些前瞻性陳述中明示或暗示的結果有重大差異，這些前瞻性陳述在我們的SEC 文件中進行了更詳細的討論，我們鼓勵您閱讀這些文件，並且可以在我們公司網站的投資者部分找到這些文件。謝謝。

Hello, and welcome to our second quarter earnings call. I am pleased that you could join us. Since our last earnings call, we have made progress on multiple fronts, which you can see in our earnings presentation or slides 5.

您好，歡迎參加我們的第二季財報電話會議。我很高興你能加入我們。自從上次財報電話會議以來，我們在多個方面取得了進展，您可以在我們的財報簡報或投影片 5 中看到這些進展。

First, we announced positive top line results from CARTITUDE-4. In the prespecified second interim analysis, our CARTITUDE demonstrated statistically significant and clinically meaningful improvement in overall survival compared to standard therapies. We look forward to presenting this important data set at major medical meetings in the coming months.

首先，我們宣布了 CARTITUDE-4 的正面頂線結果。在預先指定的第二次中期分析中，我們的 CARTITUDE 證明與標準療法相比，整體存活率具有統計學意義和臨床意義的改善。我們期待在未來幾個月的主要醫學會議上展示這項重要數據集。

Additionally, at ASCO in EHA, we provided new data from the Phase 2 CARTITUDE-2 study, a new and updated data from the Phase 3 CARTITUDE-4 study. We would like to bring to our attention a recent paper published in nature. As you will see on slide 6, data were reviewed from 339 multiple myeloma patients treated at Mayo Clinic with antibody drug conjugates, CAR-T and T-cell engagers targeting BCMA in the period of 2018 through 2023, with a median follow-up of 21 months.

此外，在 EHA 的 ASCO，我們提供了第 2 階段 CARTITUDE-2 研究的新數據、第 3 階段 CARTITUDE-4 研究的新數據和更新數據。我們想提請大家注意最近在《自然》雜誌上發表的一篇論文。正如您將在幻燈片6 中看到的，我們回顧了2018 年至2023 年期間在Mayo Clinic 使用抗體藥物偶聯物、CAR-T 和針對BCMA 的T 細胞接合劑治療的339 名多發性骨髓瘤患者的數據，中位追蹤時間為21個月。

The study found that CAR-T and T-cell engagers demonstrated superior efficacy in both PFS and OS to that of ADCs. The authors also concluded that where feasible CAR-T should be the initial BCMA directed therapy. We are encouraged by the real-world clinical evidence of CAR-T efficacy, particularly the insight it provides into strong efficacy of CARVYKTI.

研究發現，CAR-T 和 T 細胞接合劑在 PFS 和 OS 方面均表現出優於 ADC 的功效。作者也得出結論，在可行的情況下，CAR-T 應該是最初的 BCMA 定向治療。我們對 CAR-T 功效的真實臨床證據感到鼓舞，特別是它提供了對 CARVYKTI 強大功效的見解。

As many of you know, our expansive CARVYKTI dataset enables us to continue building a strong foundation for our market penetration. On this note, we recently added two regulatory approvals to global market opportunity you see on slide 7, the United Kingdom's Medicines and Healthcare products, Regulatory Agency approved CARVYKTI for second-line multiple myeloma and Health Canada approved CARVYKTI as well. Our efforts to bring CARVYKTI to more patients globally translated into net trade sales for the second quarter of $186 million, which is a 50% increase year over year and 18.5% increase quarter-over-quarter. As you will see on slide 9.

正如許多人所知，我們廣泛的 CARVYKTI 資料集使我們能夠繼續為我們的市場滲透奠定堅實的基礎。在這一點上，我們最近在幻燈片7 上看到的全球市場機會中添加了兩項監管批准，英國的藥品和保健產品，監管機構批准了CARVYKTI 用於二線多發性骨髓瘤，加拿大衛生部也批准了CARVYKTI。我們將 CARVYKTI 帶給全球更多患者的努力轉化為第二季淨貿易銷售額 1.86 億美元，年增 50%，季增 18.5%。正如您將在幻燈片 9 中看到的那樣。

The increase in our second quarter performance versus the first quarter was a result of the ongoing launch of CARVYKTI and the share gains from capacity expansion and manufacturing efficiencies. Importantly, we continue to see growth in patient demand, and we are reiterating our expectation for pronounced growth for CARVYKTI in the second half of the year, as we continue to add more slots and expand our capacity. We remain laser focused on making more supply available to the market and reducing vein-to-vein time.

我們第二季業績較第一季有所成長是由於 CARVYKTI 的持續推出以及產能擴張和製造效率帶來的份額成長。重要的是，我們繼續看到患者需求的成長，我們重申我們對 CARVYKTI 在今年下半年顯著成長的預期，因為我們將繼續增加更多的床位並擴大我們的產能。我們仍然專注於向市場提供更多供應並減少靜脈到靜脈的時間。

Turning to slide 11, our CMO, Novartis has begun clinical production of CARVYKTI the US. This frees up production capacity for commercial production at our facility in Raritan, New Jersey. We're on track to complete physical expansion of the Raritan site anticipate approval of the new section of route in the second half of 2025.

轉向幻燈片 11，我們的首席行銷長諾華 (Novartis) 已開始在美國進行 CARVYKTI 的臨床生產。這釋放了我們位於新澤西州拉里坦工廠的商業生產能力。我們正按計畫完成力登工廠的實體擴建，預計新路段將於 2025 年下半年獲得批准。

We continue to expect that our Obelisc facility in Ghent, Belgium will be approved for commercial production later this year. We more than doubled our CARVYKTI production capacity in 2023 and are on track for continued expansion. The increases to our production capacity will help us keep up with growing patient demand.

我們仍然預計我們位於比利時根特的 Obelisc 工廠將於今年稍後獲得商業生產批准。到 2023 年，我們的 CARVYKTI 產能將增加一倍以上，並且有望繼續擴張。我們產能的增加將幫助我們滿足不斷增長的患者需求。

Our cash balance now stands at $1.3 billion, which we believe provides us the resources needed to increase production, as I just mentioned, and gives us financial runway into 2026, when we expect to begin to achieve an operating profit. In other developments, we continue to bring more hospitals online as authorize treatment centers.

我們的現金餘額目前為13 億美元，正如我剛才提到的，我們相信這為我們提供了增加產量所需的資源，並為我們提供了到2026 年的財務跑道，屆時我們預計將開始實現營業利潤。在其他方面，我們繼續讓更多醫院作為授權治療中心上線。

We now have a total of 77 US hospitals, 35 to treat CARVYKTI patients. Outpatient treatment now comprises approximately 40% of our volume and remains an important medium for us as we expand our marketing efforts in the community setting for the second line and beyond.

我們現在美國共有77家醫院，其中35家來治療CARVYKTI患者。目前，門診治療約占我們治療量的 40%，隨著我們在社區環境中擴大二線及其他線的營銷工作，門診治療仍然是我們的重要媒介。

Finally, turning to our pipeline on slide 13, I am pleased to share that we recently completed CARTITUDE-5 enrollment. As you may recall, this randomized Phase 3 study evaluates patients with newly diagnosed multiple myeloma for whom stem cell transplant is not planned as initial therapy. If we were to receive approvals based on CARTITUDE 5 and CARTITUDE-6, we would translate into an additional 52,000 patients annually.

最後，轉向幻燈片 13 上的管道，我很高興地告訴大家，我們最近完成了 CARTITUDE-5 註冊。您可能還記得，這項隨機 3 期研究評估了新診斷的多發性骨髓瘤患者，這些患者並未計劃將幹細胞移植作為初步治療。如果我們獲得基於 CARTITUDE 5 和 CARTITUDE-6 的批准，我們每年將新增 52,000 名患者。

I'm also pleased to share that we recently broke ground on the new state of the art Research Center in Philadelphia to advance our portfolio of next-generation cell therapies. We are excited to expand our research presence in the US and attract top talent from the growing biotechnology innovation hub of Philadelphia, the birthplace of Gene and Cell Therapy.

我還很高興地告訴大家，我們最近在費城新建的最先進的研究中心破土動工，以推進我們的下一代細胞療法組合。我們很高興能夠擴大我們在美國的研究業務，並從基因和細胞療法的誕生地費城不斷發展的生物技術創新中心吸引頂尖人才。

In summary, we are executing against the substantial opportunity ahead of us as we expand our manufacturing capabilities and increase our earlier line commercial activities with an eye towards investment in future transformative cell therapies.

總之，隨著我們擴大製造能力並增加我們的早期商業活動，著眼於對未來變革性細胞療法的投資，我們正在抓住擺在我們面前的巨大機會。

Now I would like to turn the call over to Lori, to walk you through the financials for the second quarter. Lori?

現在我想將電話轉給洛里，讓您了解第二季的財務狀況。洛瑞？

Thank you, Ying, good morning, everyone. As Jean mentioned, we generated approximately $186 million in total net sales for EBIT during the second quarter, an increase of 60% year over year, driven by the progress we have made with ongoing market launches, expanding market share and capacity improvements. As a reminder, we share equally in all profits and losses occur, ex China, with our partner Johnson.

謝謝瑩，大家早安。正如 Jean 所提到的，我們第二季的息稅前利潤淨銷售額約為 1.86 億美元，年增 60%，這得益於我們在持續推出市場、擴大市場份額和提高產能方面取得的進展。謹此提醒，我們與我們的合作夥伴約翰遜平等分享中國以外發生的所有利潤和損失。

Turning to our revenue, as you'll see on slide 14, total revenues for the second quarter were $187 million, consisting of $93 million of collaboration revenue from the sale of gravity and license revenue of $91 million, driven by $75 million revenue recognized in connection with milestones achieved under the Johnson agreement for sit to sell $16 million in recognition of deferred revenue in connection with our agreement with Novartis to develop, manufacture and commercialize LB2102 and other potential CAR-T therapies selectively targeting DL3. Net loss for the quarter ended June 30, 2024 was $18 million or a loss of $0.05 per share compared to a net loss of $199 million or a loss of $0.57 per share for the same period last year.

談到我們的收入，正如您將在幻燈片14 中看到的那樣，第二季度的總收入為1.87 億美元，其中包括來自重力銷售的9300 萬美元的協作收入和9100 萬美元的許可收入，其中7500 萬美元的收入來自於與根據Johnson 協議實現的里程碑有關，Sit 出售1600 萬美元，以確認與我們與諾華簽署的關於開發、製造和商業化LB2102 以及選擇性針對DL3 的其他潛在CAR-T療法的協議有關的遞延收入。截至 2024 年 6 月 30 日的季度淨虧損為 1,800 萬美元，即每股虧損 0.05 美元，而去年同期淨虧損為 1.99 億美元，即每股虧損 0.57 美元。

Moving on to expenses on slide 15. Collaboration cost of revenue for the second quarter 2024 was $45 million compared to $33 million for the same period last year. These are Legends portion of collaboration cost to sales in connection with the collaboration revenue under the Johnson agreement, along with expenditures to support the manufacturing capacity expansion.

接下來是投影片 15 上的費用。這些是與約翰遜協議下的合作收入相關的合作銷售成本的 Legends 部分，以及支持製造能力擴張的支出。

Additionally, cost of license and other revenue for the second quarter of 2024 was $5 million compared to no cost of license or other revenue for the second quarter of 2023. These costs are in connection with our agreement with Novartis to develop, manufacture and commercialize LV2102 and other potential CAR-T therapies selectively targeting DL3.

此外，2024 年第二季的授權成本和其他收入為 500 萬美元，而 2023 年第二季沒有授權成本或其他收入。選擇性標靶DL3 的潛在CAR-T 療法。

Research and development expenses for the second quarter 2024 for $113 million compared to $96 million for the same period last year, an increase of $17 million for the three months ended June 30, 2024 compared to three months ended June 30, 2023 was due primarily to research and development activities and to sell, including startup costs for clinical production in Belgium and continued investment in our solid tumor programs.

2024年第二季的研發費用為1.13億美元，去年同期為9,600萬美元，截至2024年6月30日止三個月較截至2023年6月30日止三個月增加1,700萬美元，主要是由於研發活動和銷售，包括比利時臨床生產的啟動成本以及對我們實體瘤計畫的持續投資。

Administrative expenses for the three months ended June 30, 2024, were $35 million compared to $28 million for the same period last year. The increase of $8 million year over year is primarily due to the expansion of administrative functions and infrastructure to support the increased manufacturing capacity.

截至 2024 年 6 月 30 日止三個月的管理費用為 3,500 萬美元，而去年同期為 2,800 萬美元。年比增加 800 萬美元主要是由於行政職能和基礎設施的擴大，以支持製造能力的提高。

Selling and distribution expense for three months ended June 30, 2024 was $30 million compared to $21 million for the same period last year. The increase of $9 million year over year due to costs associated with commercialization activity, including the expansion of sales force and second line indication launch preparations.

截至 2024 年 6 月 30 日止三個月的銷售和分銷費用為 3,000 萬美元，而去年同期為 2,100 萬美元。由於與商業化活動相關的成本（包括擴大銷售團隊和二線適應症上市準備），較去年同期增加 900 萬美元。

To summarize, our spending remains on track, and we continue to maintain a strong balance sheet. As of June 30, we have $1.3 billion in cash equivalents, deposits and investments. Thus, we believe we have sufficient capital to fund our operating and capital expenditures into 2026 when we expect to begin to achieve an operating profit.

總而言之，我們的支出仍處於正軌，我們繼續保持強勁的資產負債表。截至 6 月 30 日，我們擁有 13 億美元的現金等價物、存款和投資。因此，我們相信我們有足夠的資本來為 2026 年的營運和資本支出提供資金，屆時我們預計將開始實現營運利潤。

Thank you. I will now pass it back to Ying, for closing remarks.

謝謝。現在我將其傳回給Ying，供其結案陳詞。

Thanks Lori. To sum up, our team remains dedicated to our strategic priorities. I am pleased to share that we recently surpassed 3,000 CARVYKTI patients treated to date, reflecting our deep commitment to multiple myeloma patients and their families. I'd like to thank each of our employees for their dedication to the patients we serve as we steadfastly execute our capacity expansion and also our commercial launch in second line.

謝謝洛瑞。總而言之，我們的團隊仍然致力於我們的戰略重點。我很高興地告訴大家，迄今為止，我們最近已治療超過 3,000 名 CARVYKTI 患者，這反映了我們對多發性骨髓瘤患者及其家人的堅定承諾。我要感謝我們的每位員工在我們堅定不移地進行產能擴張以及二線商業啟動的過程中對我們所服務的患者的奉獻。

Before we open it up for Q&A, I'd like to assure you that our Board and management team have been taking a close look at our business to ensure we are best positioned to continue our growth and momentum as we advance our mission to help multiple myeloma patients. We know there has been recent speculation about potential political risk, particularly given this being an election year, our board is active and engaged and continues to assess the potential impact of those risks.

在我們開始問答之前，我想向您保證，我們的董事會和管理團隊一直在密切關注我們的業務，以確保我們在推進幫助多個國家的使命時處於最佳位置，能夠繼續我們的成長和勢頭。我們知道最近有人猜測潛在的政治風險，特別是考慮到今年是選舉年，我們的董事會積極參與，並繼續評估這些風險的潛在影響。

We're not going to speculate on hypotheticals on this call. But rest assured, we are focused on driving shareholder value as we consider our path forward. If and when we have updates to share, we will provide them at the right time. In the meantime, we appreciate if you can keep your questions focused on our earnings results. And with that, we'd like to take your questions.

我們不會對這次電話會議做出假設。但請放心，在考慮我們的前進道路時，我們將專注於推動股東價值。如果我們有更新要分享，我們將在適當的時間提供。同時，如果您能將問題集中在我們的獲利結果上，我們將不勝感激。因此，我們願意回答您的問題。

Operator, we're ready for the first question.

接線員，我們準備好回答第一個問題了。

(Operator instructions)

（操作員說明）

Gena Wang, Barclays.

王吉娜，巴克萊銀行。

Thank you, I know you said we should not ask anything about speculative comments. I know you also cannot comment too much, but I do wanted to ask because this is the number one, it is a major overhang on the stock regarding potential political country risk and biosecurity impact to the stock. I know you cannot comment too much.

謝謝您，我知道您說過我們不應該詢問任何有關投機性評論的資訊。我知道您也不能發表太多評論，但我確實想問，因為這是第一，就潛在的政治國家風險和生物安全對股票的影響而言，這是股票的主要懸念。我知道你不能評論太多。

But, I don't know how much can you share some a little bit more color rather than very high level comments? You'll have a little bit more color on what you could do or the company is in the process to prepare and to address this potential questions.

但是，我不知道您能分享多少更多的色彩而不是非常高水準的評論？您將對您可以做什麼或公司正在準備和解決這些潛在問題有更多的了解。

And the second is regarding the New Jersey Warrington site. As of now, Novartis already has a clinical production in July 2024. Is it fair to say now the warranty side is 100% commercial product?

第二個是關於新澤西州沃靈頓站點。截至目前，諾華已於2024年7月進行臨床生產。

Yes, sure, and thank you for your questions on. Maybe I can address the second question first. So you're right since some July, Novartis site in March, when New Jersey has initiated clinical production, the first patient was coming from car to six and that follows the IND clearance by the FDA. So right now, we are in a process of shifting more clinical trial patients to the production side.

是的，當然，感謝您提出的問題。也許我可以先解決第二個問題。所以你是對的，從 7 月開始，諾華工廠在 3 月新澤西州開始臨床生產，第一個患者從車上來到了 6 名患者，這是在 FDA 批准 IND 後進行的。所以現在，我們正在將更多的臨床試驗患者轉移到生產方面。

The Novartis are more cell sites however, we do still have certain production for clinical trials in the routing side and over the next few months with the cancer side going commercial and Novartis ramping up clinical trial production. I think you should expect that the percentage of clinical production will go lower in bright. So that's about routing.

諾華有更多的細胞站點，但是，我們在路由方面仍然有一定的臨床試驗生產，在接下來的幾個月裡，隨著癌症方面的商業化，諾華也加大了臨床試驗的生產。我認為你應該預料到臨床生產的百分比將會降低。這就是路由的問題。

And then your first question on and first of all, I can say that we have carefully evaluated the draft bill and also we have been engaging with certain stakeholders in Washington, DC, including on committee and house Vickers office. So at this point, we do not believe there will be any direct impact to Legend and given how our operation model is and how in terms of data and also IP flow, we conduct the business. So suffice to say that we are not too concerned that our target of the passenger appeal. Thank you.

然後是你的第一個問題，首先，我可以說，我們已經仔細評估了該法案草案，而且我們一直在與華盛頓特區的某些利益相關者進行接觸，包括委員會和眾議院維克斯辦公室。因此，考慮到我們的營運模式以及資料和 IP 流方面的業務開展情況，我們認為這不會對聯想產生任何直接影響。可以說，我們並不太關心我們的乘客目標的吸引力。謝謝。

Jessica Fye, JPMorgan.

潔西卡法耶，摩根大通。

Hey, guys, good morning. Thanks for taking my questions, which outpatient use now up the 40%, can you just remind us where that was last quarter and is the increase kind of coming across the board like as that proportion it is up? Or is this more dynamic where new institutions coming on are say 100% outpatient, and that's what's driving the change.

嘿，夥計們，早安。感謝您回答我的問題，哪個門診使用量現在增加了 40%，您能否提醒我們上個季度的情況，以及成長是否像這個比例一樣全面成長？或者說，這種情況是否更具活力，即將出現的新機構據說是 100% 門診病人，而這正是推動這項改變的原因。

And then I also wanted to follow up on in his question and recognizing that it doesn't look like you're directly impacted by bio secure, but the stock really did come under pressure in the first half of the year as a result.

然後我還想跟進他的問題，並認識到您看起來並沒有直接受到生物安全的影響，但該股票在今年上半年確實面臨壓力。

Can you just talk about what you see as the best path forward for shareholder value creation.

您能否談談您認為創造股東價值的最佳方法是什麼？

And does it make sense for Legend you stand on company heading into a potentially contentious political period in the US? Or should the Board be considering other alternatives?

對於傳奇公司來說，您所代表的公司即將進入美國潛在的有爭議的政治時期，這有意義嗎？或者董事會是否應該考慮其他替代方案？

It, Steve, why don't I take the first one, Jessica? Your question has to do with outpatient outpatient trends where those patients are coming from. So US also quarter over quarter. So last quarter we reported that we were at 35% outpatient actually were trending closer right now to 45% as opposed to 40. So there's a significant jump up in outpatient use in the US in terms of where is that coming from?

史蒂夫，我為什麼不選第一個呢，潔西卡？您的問題與這些患者來自哪裡的門診趨勢有關。美國也是逐季成長。上個季度我們報告說，我們的門診患者比例為 35%，實際上現在正接近 45%，而不是 40%。

If you look at the US on volume in the sites that we serve is largely top-heavy. So you see largely about the top 2015 to 20% of these hospitals driving the majority of the volume. So the majority of the outpatient volume we see is in our large academic centers as opposed to evenly spread throughout our 77 sites right now. Typically the rate limiter to get a site onboard or lease using, I should say, perfectly in the outpatient setting, just reps are patient rapid repetitions.

如果你看看美國，我們所服務的網站的訪問量基本上是頭重腳輕的。因此，您會看到，2015 年，這些醫院中排名前 20% 的醫院佔據了大部分銷售。因此，我們看到的大部分門診量都在我們的大型學術中心，而不是目前均勻分佈在我們的 77 個站點。我應該說，通常情況下，在門診環境中獲得站點使用或租賃使用的速率限制器完全是代表耐心的快速重複。

And and as we bring new sites onboard, that's the key thing that they are looking for is just trying to understand in the real-world setting is a toxicity profile, a profile similar to what we see in a registration study. So that's how it spread out right now, but I just wanted to make sure we have the corrected percentage. We're trending right at 45% right now for the quarter. I'll turn it back over to Ying.

當我們引入新網站時，他們正在尋找的關鍵是試圖了解現實世界中的毒性概況，類似於我們在註冊研究中看到的概況。這就是它現在的傳播方式，但我只是想確保我們有正確的百分比。目前本季的趨勢為 45%。我會把它轉回給Ying。

So we've been a public company for about four years. And I think in that period as a company, Legend has made tremendous progress delivering for patients. We also have achieved numerous milestones and data. If you look at our recent second line approval in both the US and Europe and also the preliminary feedback from the field and what we can see from the order book and production data.

我們成為上市公司已有四年了。我認為，在那個時期，傳奇公司在為患者提供服務方面取得了巨大進步。我們也取得了許多里程碑和數據。如果你看看我們最近在美國和歐洲的二線批准以及現場的初步反饋以及我們從訂單和生產數據中可以看到的情況。

Clearly, there's a lot of potential in the new indication, and we just announced that we've completed enrollment for CARTITUDE-5. That's another entry into the frontline. So we certainly believe that there's a lot of growth ahead of us, and we remain confident in our current long-term strategy to realize the full potential of correctly and also advance our pipeline as we continue to develop innovative, but treat us shouldn't options.

顯然，新適應症有很大的潛力，我們剛剛宣布我們已經完成了 CARTITUDE-5 的註冊。這是又一次進入前線。因此，我們當然相信我們前面還有很大的成長空間，我們對當前的長期策略充滿信心，以正確地充分發揮潛力，並在我們繼續開發創新的同時推進我們的管道，但對待我們不應該選項。

So I think, you know, it's not a one answer or one way to create or maximize shareholder value, although as I mentioned on at this point, our bodies are engaged with investors and other stakeholders. And obviously, we have the fiduciary responsibility of maximizing shareholder value. And so that's pretty much what I can say about this. Thank you.

因此，我認為，這不是創造或最大化股東價值的唯一答案或一種方式，儘管正如我在這一點上提到的，我們的機構正在與投資者和其他利害關係人接觸。顯然，我們負有股東價值最大化的信託責任。關於這一點我能說的就這麼多了。謝謝。

Thank you.

謝謝。

Kelly Shi, Jefferies.

施凱莉，傑弗里斯。

Thank you for taking my questions. System approval in second line and for correct here, how do you see the demand and the use in second-line patients change over time? And also one, only one patient received the curve if you treat them into what is the typical patient baseline characteristics regarding prior therapies, refractoriness and performance status either fashion? Thank you.

感謝您回答我的問題。二線系統的批准以及此處的正確性，您如何看待二線患者的需求和使用隨著時間的推移而變化？還有一個，只有一名患者收到曲線，如果您將他們治療為有關先前治療、不應性和表現狀態的典型患者基線特徵，無論哪種方式？謝謝。

Hi Kelly, it's Steve. When I take the question in terms of how the launch is going and where we're seeing the use, et cetera. And so just to remind folks that we launched early part of the quarter. So you really didn't start to see the impact from a revenue perspective until late in the quarter. We're starting to see it more pronounced. The now in the third quarter.

嗨，凱利，我是史蒂夫。當我提出有關發布進度如何以及我們在哪裡看到使用等問題時。只是為了提醒大家，我們是在本季初推出的。因此，直到本季末，您才真正開始從收入角度看到影響。我們開始看到它更加明顯。現在已經是第三季了。

So that's the first thing a lot of the performance we saw in the second quarter was off of CARTITUDE-1 indication as opposed to CARTITUDE-2. However, you did see again some some uptick at the end of the quarter. What we are seeing in terms of some of the leading indicators, and we're measuring this through the data that we are analyzing through our ordering portal.

因此，這是我們在第二季度看到的許多表現都偏離了 CARTITUDE-1 指示的第一件事，而不是 CARTITUDE-2 指示。然而，您確實在本季度末再次看到了一些上升。我們在一些領先指標方面看到了什麼，我們正在透過訂購入口網站分析的數據來衡量這一點。

We're seeing right now on average about between 50% to 60% of new patient orders coming into our portal is related to the CARTITUDE-4 indications. So that's a very good demonstration of good leading indicator of hopefully what we see moving forward.

目前，我們發現進入我們入口網站的新患者訂單中平均有 50% 至 60% 與 CARTITUDE-4 適應症相關。因此，這是一個很好的領先指標，希望我們能看到未來的發展。

Now, again, these are not treated patients. These are patients that are entering the quarter portal For scheduling purposes, but I did want to provide that data point on to you. In terms of actual data, we won't be able to see the data coming through the claims and channels until towards the end of this month is when we'll start to start to see that.

現在，再說一次，這些都不是接受治療的患者。這些患者是出於安排目的而進入季度入口網站的，但我確實想向您提供該數據點。就實際數據而言，我們將無法看到透過聲明和管道傳遞的數據，直到本月底我們才會開始看到這一點。

And that will give us more objective evidence in terms of exactly what line of therapy these patients are are seeing the use. But we're very, very excited by the fact that we're seeing over 50% of all inbound patients at least in our ordering quarter portal come coming through the CARTITUDE-4 indication.

這將為我們提供更客觀的證據，說明這些患者正在使用什麼療法。但我們非常非常興奮的是，至少在我們的訂購季度入口網站中，我們看到超過 50% 的入境患者來自 CARTITUDE-4 適應症。

Thank you

謝謝

Ash Verma, UBS.

阿什‧維爾瑪，瑞銀集團。

Good morning. Thanks for taking our questions. So maybe they go first one. So you saw the Galapagos part, their BCMA CAR-T study on finding Parkinsonism. Can you comment on how correctly binder compares to the Galapagos compound? And does this make you believe that M&T's could be something that is more specific to chemically derived antibodies like yours?

早安.感謝您回答我們的問題。所以也許他們先走。所以你看到了加拉巴哥群島的部分，他們的 BCMA CAR-T 研究發現帕金森氏症。您能否評論一下黏合劑與加拉巴哥化合物的比較是否正確？這是否讓您相信 M&T 可能對像您這樣的化學衍生抗體更具特異性？

And then just secondly, on the on the 2Q, the 3Q dynamic, so that the 9% price increase that you talked like, is that benefit mostly realized in 2Q sales already? Or could that also be an additional tailwind for 3Q? Thanks.

其次，在第二季、第三季的動態上，您所說的 9％ 的價格上漲，是否已經在第二季的銷售中實現了大部分收益？或者這也可能成為第三季的額外推動力？謝謝。

And as the senior, thanks for the questions up. So on the first one on, yes, we did see what happened that the collateral collaborative program. And I think, you know, obviously MNT or the movement and neurological on toxicity, it's not coming from just BCMA is not just coming from CAR-T either, although the mechanism of that action has not been well elucidated with our science experiments state.

作為前輩，感謝您提出的問題。因此，在第一個專案中，是的，我們確實看到了附帶合作專案所發生的情況。我認為，你知道，顯然 MNT 或運動和神經毒性，它不僅僅來自 BCMA，也不僅僅來自 CAR-T，儘管我們的科學實驗狀態尚未很好地闡明該作用的機制。

We think, you know, obviously, you have to watch this in the clinic and that if you look at the data from our commercial launch of correctly, I'm sure everyone follows the same FDA our database in the first quarter. We saw 21 cases reported for PBC patients and that went down to seven cases in the second quarter, while we dramatically increased the population of treated patients by carbon. So we feel really confident about the safety profile demonstrated by corporate in the real world here.

我們認為，顯然，你必須在診所中觀察這一點，如果你正確地查看我們商業發布的數據，我確信每個人都遵循第一季 FDA 的相同資料庫。我們看到報告的 PBC 患者有 21 例，第二季下降到 7 例，同時我們通過碳治療的患者人數大幅增加。因此，我們對企業在現實世界中所展現的安全狀況非常有信心。

And then secondly, we also believe that our risk mitigation strategy is working very well in the clinic and also in the trials. So that's what I can say about the MNT and neurotox here. On the second question, I believe in the second quarter, the last ramp-up was mostly reflected, although it's not fully 100% reflected in the second quarter. So we continue to reap that benefit in the third quarter. Thank you.

其次，我們也相信我們的風險緩解策略在臨床和試驗中都非常有效。這就是我在這裡可以說的關於 MNT 和神經毒素的內容。關於第二個問題，我認為在第二季度，上次的成長大部分都得到了體現，儘管在第二季度並沒有完全100%反映出來。因此，我們在第三季繼續受益。謝謝。

Leonid Timashev, RBC Capital Markets.

列昂尼德·蒂馬舍夫（Leonid Timashev），加拿大皇家銀行資本市場。

Thanks. I shouldn't ask on them. You mentioned that you recently hit overall survival and CARTITUDE-4 and obviously there was some discussion of the overall survival endpoint at the advisory committee. So I guess some just curious on that. I guess what are you hearing from physicians about the importance of this data.

謝謝。我不應該問他們。您提到您最近達到了總體生存率和 CARTITUDE-4，顯然諮詢委員會對總體生存率終點進行了一些討論。所以我想有些人只是對此感到好奇。我想您從醫生那裡聽到了關於這些數據重要性的說法。

I mean, did you sense that there were perhaps any physicians are waiting to continue to use cavity in earlier lines to see more overall survival data expectation of when you might see this on the label and sort of how this is going to impact your overall marketing strategy?

我的意思是，您是否感覺到可能有醫生正在等待繼續在早期產品線中使用腔體，以查看更多的總體生存數據，期望您何時可以在標籤上看到這一點，以及這將如何影響您的整體行銷策略？

And maybe I'll take that, Steve. The I mean, physicians are very excited with this data for actually, we have a pretty large study right now, fielded tested to look at different hazard ratios to see what perspective the the market has on that. But generally speaking at all of our advisory board, as you can imagine, it's very, very positive from the question we have and I'm sure it may be that you have is does this data start to open up more the standard risk population in earlier earlier lines.

也許我會接受，史蒂夫。我的意思是，醫生們對這些數據感到非常興奮，因為實際上，我們現在有一項相當大的研究，透過現場測試來觀察不同的風險比，看看市場對此有何看法。但總的來說，正如您可以想像的那樣，我們所有的諮詢委員會從我們提出的問題來看，這是非常非常積極的，我相信您可能會發現，這些數據是否開始開放更多的標準風險人群較早較早的線路。

So we'll see we just don't have an answer for you yet, but we'll have that once we get this data to readout. But generally speaking, as you can imagine, we're very enthusiastic by it. I mean, you take the next question from.

所以我們會發現我們還沒有給你答案，但一旦我們讀出這些數據，我們就會得到答案。但總的來說，正如你可以想像的，我們對此非常熱情。我的意思是，你回答下一個問題。

Yeah, I'll talk about the other part of the question, which is are we and J&J teams are working on cleaning up the data. And we do have plans to submit to the agencies, including FDA and EMA on survival on label expansion. So hopefully the data will be published at a major medical meeting soon. And you will see the magnitude of benefit for which you already had a preview at Kodak, and we see a statistically significant and also clinically meaningful separation here on survival benefit, which is very, very important, as you know, given that myeloma is still incurable many patients cycle through different therapies.

是的，我將討論問題的另一部分，即我們和強生團隊正在努力清理資料。我們確實有計劃向 F​​DA 和 EMA 等機構提交有關標籤擴展生存問題的計劃。因此希望這些數據很快就能在一次重要的醫學會議上公佈。您將看到您已經在柯達預覽過的益處的大小，我們在這裡看到生存益處具有統計意義和臨床意義的分離，正如您所知，鑑於骨髓瘤仍然存在，這是非常非常重要的。許多無法治癒的患者循環使用不同的療法。

So it's been very difficult to show it a meaningful and also significant survival benefit in the clinical trials. And I think Kartik is one of the few of trucks out there, which will have a survival benefit on the label. So we think it's going to be a very powerful tool in the promotions and also when we explained the benefit to our physicians and patients are literally in the second line by not having the late-line.

因此，很難在臨床試驗中證明它具有有意義且顯著的生存益處。我認為 Kartik 是市場上為數不多的能夠在標籤上帶來生存效益的卡車之一。因此，我們認為這將成為促銷中非常強大的工具，當我們解釋對醫生和患者的好處時，它實際上是在第二線，因為沒有晚線。

So if you look at competition or upcoming competition, we think we may be the only one with that kind of benefit potentially on the label. And again, that's a huge differentiation factor. And obviously, if you talk to physicians in the field, right they care about certain things, but survival is one of the top considerations compared to also PFS and CR rate. So we feel really, really good about a strong benefit demonstrated in such a global randomized active control trial without benefit.

因此，如果你看看競爭或即將到來的競爭，我們認為我們可能是唯一一家在標籤上具有這種潛在優勢的公司。再說一遍，這是一個巨大的差異化因素。顯然，如果您與該領域的醫生交談，您會發現他們關心某些事情，但與 PFS 和 CR 率相比，生存是首要考慮因素之一。因此，我們對於在這樣一項沒有益處的全球隨機主動對照試驗中所證明的強大益處感到非常非常高興。

Jonathan Miller, Evercore ISI.

喬納森·米勒，Evercore ISI。

I guess, thanks for taking my question and congrats on all the progress. Your lots of manufacturing news and expansion expected second happening as you as you went through. But could you walk us through what the delta is between all of that stuff that's coming on and in the second half and the guidance for end of '25, what is left to be done in '25 that's going to take you from end of this year to end of that year.

我想，感謝您提出我的問題並祝賀所有的進展。您的許多製造業新聞和擴張預計會在您經歷時發生。但是，您能否向我們介紹下半年即將發生的所有事情與 25 年底的指導之間的差異是什麼，25 年底還需要做什麼，這將帶您完成本年底的工作年至該年年底。

And then secondly, you mentioned the enormous market potential for newly diagnosed setting. Obviously, there's a lot of patients there, but there's already so many more patients than you're even your manufacturing guidance covers is manufacturing ever going to be sufficient to cover the extensible market here, even even if you look out five or more years.

其次，您提到了新診斷環境的巨大市場潛力。顯然，那裡有很多病人，但病人的數量已經比你的製造指南所涵蓋的要多得多，即使你展望五年或更長時間，製造是否足以覆蓋這裡的可擴展市場。

And Jonathan, thank you for the questions. On the first one, I can layout of what we expect to have in between end of this year and have '25 or so of switching end of this year, by which time we should have commercial production in our first facility in Ghent, Belgium cause of risk. Right now, we're expecting a commercial approval by end of next month in September.

喬納森，謝謝你的提問。在第一個方面，我可以規劃我們預計在今年年底之間實現的目標，並在今年年底左右進行25 年左右的轉換，到那時我們應該在比利時根特的第一個工廠進行商業生產，因為的風險。目前，我們預計將於 9 月底獲得商業批准。

And then we can start our first commercial production in Europe and then on by end of this year. Also, we expect the construction activities to complete in the other facility in Belgium called tech land. So by early next year in the first half, first, we do expect the clinical production to come from the tech land facility in Ghent, Belgium to start. And then after that, on sometime in first half of '25, we expect Novartis our Morris Plains, New Jersey site to also start commercial production pending FDA approval.

然後我們可以在歐洲開始我們的首次商業生產，然後在今年年底開始。此外，我們預計建設活動將在比利時另一個名為「科技園區」的設施中完成。因此，到明年初上半年，我們確實預期臨床生產將在比利時根特的科技園區開始。此後，在 25 年上半年的某個時間，我們預計諾華位於新澤西州莫里斯平原的工廠也將開始商業生產，等待 FDA 批准。

And then after that, in the second half of 2025, we have two major milestones here first, we expect the expansion of resin side to gain FDA approval to start commercial production in the second half of '25. And the other upcoming milestone is in the second half of 2025. We also expect the tech land facility in Ghent, Belgium to start commercial production. So this is a the cadence of all the different nodes that could happen between end of this year and of next year.

然後，在2025年下半年，我們在這裡有兩個重要的里程碑，首先，我們預計樹脂的擴張將獲得FDA批准，在25年下半年開始商業生產。另一個即將到來的里程碑是在 2025 年下半年。因此，這是今年年底到明年之間可能發生的所有不同節點的節奏。

Now in terms of the on ongoing launch in second line and also future opportunities in first line, you're right, we and our partner. J&J have already been having a lot of productive discussions about how we can satisfy the demand, especially given the very encouraging uptake in second line, only three months after launch. I know there are many skeptics saying that. Well, where's the second line demand?

現在，就第二線的持續推出以及一線的未來機會而言，您是對的，我們和我們的合作夥伴。強生公司已經就如何滿足需求進行了大量富有成效的討論，特別是考慮到二線產品上市僅三個月後就獲得了非常令人鼓舞的採用。我知道有很多懷疑論者這麼說。那麼，二線需求在哪裡呢？

We have a queue in Raritan. We have acute in all the major hospital centers today for second line and we are being creative here and do we and J&J are trying to think out of box in terms of finding the future supply that includes internal notes, construction of greenfield or brownfield or alternative other route. I can assure you that that is one of the highest priority of the partnership, and we have been engaging with our partners at J&J to discuss this and you should stay tuned. Thank you.

我們在 Raritan 排隊。今天，我們在所有主要醫院中心都急需二線產品，我們在這裡發揮創意，我們和強生是否正在嘗試跳出框框，尋找未來的供應，包括內部說明、綠地或棕地建設或替代方案其他路線。我可以向您保證，這是合作夥伴關係的最高優先事項之一，我們一直在與強生的合作夥伴進行討論，您應該繼續關注。謝謝。

Makes sense. And then maybe can I ask just one question on the pipeline? Since I know nobody's nobody's asked about that about that yet. When do you anticipate beginning to show data from some of those early pipeline assets that are currently in drilling phase one, especially on those dual CARs where are they relative to the single targets? And do you have expectations for the IND timing for autoimmune?

有道理。然後也許我可以只問一個關於管道的問題嗎？據我所知，還沒有人問過這個問題。您預計什麼時候開始顯示目前處於第一階段鑽探的一些早期管道資產的數據，特別是那些相對於單一目標的雙 CAR 數據？您對自體免疫類藥物的 IND 時間有預期嗎？

Thanks, Jonathan. Yes, this is Guowei. We are having multiple choice under IT, and we also have a US Phase one trial next year, we expect to see initial safety and efficacy data for Claudin 18.2 topics that are top of CAR-T, which is our US Phase 1 trial. Currently, we have IT trial in China in autoimmune indications. So this is the trial targeting CD19, CD20, CD22 tumor-targeting talks, CAR-T are being tested in a broad spectrum of different room with a logical and neurological autoimmune indication.

謝謝，喬納森。是的，這就是國偉。我們在IT方面有多種選擇，明年我們還有美國一期試驗，我們預計會看到Claudin 18.2主題的初步安全性和有效性數據，這是CAR-T的首要內容，這是我們的美國一期試驗。目前，我們在中國正在進行自體免疫適應症的IT試驗。這是針對 CD19、CD20、CD22 腫瘤靶向會談的試驗，CAR-T 正在廣泛的不同房間進行測試，具有邏輯和神經學自體免疫適應症。

The first phase you have it does that towards Q4 this year we expect to see clinical readout in 2025, as you pointed out, that we also have multiple other generic product, some reserves or do targeting oncology indications. We expect to readout data in 2025 in terms of other generic products for US R&D funding, we are activity of initiating IND-enabling studies this year, and we are projecting the R&D filing, and you asked around 2026. Thank you.

您擁有的第一階段是在今年第四季完成的，我們預計將在2025 年看到臨床結果，正如您所指出的，我們還有多種其他仿製藥產品、一些儲備或針對腫瘤學適應症。我們預計在 2025 年讀出美國研發資金的其他仿製藥的數據，我們今年正在啟動 IND 授權研究，我們正在預測研發申請，您在 2026 年左右詢問。

Yaron Werber, TD Cowen.

亞龍·韋伯，TD·考恩。

Great. Thanks for taking my question and nice growth this quarter. And maybe just a couple of questions. As you think about supply ramping in Q4 over Q3, can you give us a little bit of a sense, it looks like Q3 is going to have a meaningful jump over Q2, Q4, the same, meaningful jump and maybe slightly smaller.

偉大的。感謝您提出我的問題以及本季的良好成長。也許只是幾個問題。當您考慮到第四季度的供應量超過第三季時，您能否給我們一點感覺，看起來第三季將比第二季、第四季出現有意義的跳躍，同樣的、有意義的跳躍，而且可能會稍微小一點。

And then as you think about you've said that you can double capacity next year, but not all of that is obviously commercial capacity, right? Some of it is going to be for qualification lots and still some clinical. Can you give us maybe a little bit of that sort of doubling how much can be commercial? Thank you.

然後，正如您所言，您可以在明年將產能增加一倍，但顯然並非所有這些都是商業產能，對嗎？其中一些將用於資格批次，還有一些用於臨床。您能否提供我們一點這種雙倍的​​商業收益？謝謝。

Hey Yaron, thanks for the questions. Obviously, on the first one on. I can tell you that we expect next ramp-up to happen probably around end of this year or early next year. It's a little bit difficult for me to give you the exact timing now because obviously we need to run experiments when you collect the data, analyze data and submit to the FDA. And then there's FDA review process as you can imagine. And so it's going to be around that time, like I mentioned end of this year, beginning of next year.

嘿亞龍，謝謝你的提問。顯然，在第一個上。我可以告訴你，我們預計下一次升級可能會在今年年底或明年初左右發生。我現在很難給你確切的時間，因為顯然當你收集數據、分析數據並提交給 FDA 時，我們需要進行實驗。然後就是你可以想像的 FDA 審查流程。所以它將在那個時候左右，就像我提到的今年年底、明年年初。

We can not comment specifically on Q4, but in general I think we have said in the beginning of the year that throughout 2024, we do expect sequential growth every quarter. So you have seen that our 18.5% sequential growth from Q1. And now we do expect a much higher growth in Q3 and hopefully follow-up with the sequential growth again in Q4.

我們無法具體評論第四季度，但總的來說，我認為我們在年初曾說過，整個 2024 年，我們確實預計每個季度都會出現環比增長。所以您已經看到我們從第一季開始環比增長了 18.5%。現在我們確實預計第三季會有更高的成長，並希望第四季能夠再次實現環比成長。

So that's where we stand on production. And then on on the capacity, I will say in general, I'm going forward, right, given that our volume continues to increase higher the percentage of the clinical production and also the percentage of what we call non-revenue generating our runs will decline as a relative percentage. So I wouldn't go into too much detail. But if you look at that commercial production capacity. If we say overall capacity is doubling, then that means roughly the commercial production will double as well because and next year, we're look at a much larger batch number compared to 2024.

這就是我們在生產上的立場。然後關於產能，我會說，總的來說，我會繼續前進，對吧，鑑於我們的產量繼續增加，臨床生產的百分比以及我們所謂的非收入產生的運行的百分比將繼續增加。的形式下降。所以我不會講太多細節。但如果你看看商業生產能力。如果我們說整體產能翻倍，那麼這意味著商業產量大致上也會翻倍，因為明年我們的批次數量將比 2024 年大得多。

James Shin, Deutsche Bank.

詹姆斯‧辛，德意志銀行。

Good morning. Thanks for the question on when the C4 data unveiled later this year, is it possible that you will have a post hoc crossover OS analysis?

早安.感謝您提出有關今年稍後 C4 數據何時公佈的問題，您是否有可能進行事後交叉操作系統分析？

And my second question, as it relates to doubling of capacity, should we expect a gross margin benefit as well as '25? Thank you.

我的第二個問題，因為它與產能翻倍有關，我們是否應該期望毛利率收益以及“25”？謝謝。

I'll answer you. This is Lori. I'll answer your second question and then I'll turn it over to Ying to answer your first question, as you can imagine, as we're bringing on the different nodes, you're going to see variability in your gross margins because as you're ramping up in each of those locations, you have to get to a certain level of volume to really keep the consistency in your gross margins. But we do anticipate once all of our no other online that our gross margins will be in line with the industry standard.

我來回答你。這是洛瑞。我將回答你的第二個問題，然後我將把它交給Ying 來回答你的第一個問題，正如你可以想像的，當我們引入不同的節點時，你將看到毛利率的變化，因為當你在每個地點增加業務時，你必須達到一定的銷售水平才能真正保持毛利率的一致性。但我們確實預計，一旦我們沒有其他線上服務，我們的毛利率將符合行業標準。

Hey James, on survival question, I'm not going to be able to steal the thunder from the medical meeting presentation, but I'm sure you guys are in the survival curve from the hour that panel back in March. So overall, the shape really did not change. And in general we're encouraged by two things. Number one, yes, there was a very small early imbalance of overall survival in the very beginning of the curve as you guys saw. And but that never crossover again after that initial period rate.

嘿，詹姆斯，關於生存問題，我無法從醫學會議的演講中搶走風頭，但我確信你們從三月份的小組會議開始就處於生存曲線中。所以整體來說，形狀確實沒有改變。總的來說，我們受到兩件事的鼓舞。第一，是的，正如你們所看到的，在曲線的一開始，整體生存率存在非常小的早期不平衡。但在初始時期利率之後就再也不會交叉了。

And secondly, I think when you see the overall survival curves, you will see it's a wide separation between the two curves, not only that was very encouraged by the so-called tail, which is the flattening trend of survival after a certain period. Again, we have consistently showed that in every single trial we conduct for correctly and in every setting. So clearly, there's a portion of patients who will benefit does so in a lower in terms of PFS of CR and also overall survival. And that is very, very consistent trend. I think it's going to be hard for competition to beat.

其次，我認為當你看到整體生存曲線時，你會發現兩條曲線之間有很大的分離，這不僅受到所謂的尾部的鼓勵，尾部是一段時間後生存的扁平化趨勢。我們再次證明，在每一次試驗中，我們在每種情況下都正確進行。很明顯，部分患者將受益於較低的 PFS、CR 和總存活率。這是非常非常一致的趨勢。我認為競爭將很難被擊敗。

Thank you.

謝謝。

Vikram Purohit, Morgan Stanley.

維克拉姆‧普羅希特，摩根士丹利。

Good morning. Thank you for taking our questions. We had two both on carbon first on, I think last quarter you mentioned that there were 70 hospitals certified to treat patients with cardiac. The I think this morning you reported 77 was just curious where you think that footprint could go by and of this year and also by end of 2025.

早安.感謝您接受我們的提問。我們首先有兩家醫院都使用碳，我想上個季度您提到有 70 家醫院經過認證可以治療心臟病患者。我認為您今天早上報告的 77 個只是好奇您認為今年以及 2025 年底足跡會走向何方。

And then secondly, had a question on timing updates for some earlier line data sets. So data from CARTITUDE-2 and F from Q2 to and now that CARTITUDE-5 has completed enrollment, when do you think you might be realistic to expect initial data there? And then in the same vein of CARTITUDE-6, could you just give us an update on how enrollment is progressing versus your expectations? Thank you.

其次，有一個關於一些早期線路資料集的定時更新的問題。那麼，從第二季度到 CARTITUDE-2 和 F 的數據，現在 CARTITUDE-5 已經完成註冊，您認為何時可以現實地期望那裡的初始數據？然後，與 CARTITUDE-6 一樣，您能否向我們介紹一下註冊進度（與您的預期相比）的最新情況？謝謝。

We'll take the clinical questions. Okay. So why don't I take it, Steve, why don't I take the questions around site activation. So for Q1, we have reported 71 sites. And you're right, we're at 77 sites by year end. We are forecasting to be right around 100 sites. And again, I keep reminding during these calls, something to keep in mind is that on a per site basis because of the percentage of patients that we treat now in the outpatient setting, our throughput is very efficient versus competition in the sites that we sell into.

我們將回答臨床問題。好的。那麼，史蒂夫，我為什麼不回答有關網站啟動的問題呢？因此，對於第一季度，我們報告了 71 個站點。您是對的，到年底我們已擁有 77 個站點。我們預計大約有 100 個站點。再次，我在這些電話中不斷提醒，需要記住的是，在每個站點的基礎上，由於我們現在在門診環境中治療的患者百分比，我們的吞吐量與我們銷售的站點的競爭相比非常高效進入。

So please keep that in mind. It's not so much of a site race. It's really how many patients per site per site that we treat. I'm going to turn it over to some of the clinical questions around some of the data releases that.

所以請記住這一點。這並不是一場場地競賽。這實際上是我們每個站點治療的患者數量。我將把它轉向圍繞一些數據發布的一些臨床問題。

Yes, sure. And so all CARTITUDE-4 survival. Yes, we and also J&J are very excited about the survival benefit. We also have consulted with certain physicians again for physicians who have innovated and very encouraged by the survival benefit. Remember, this is actually our first interim survival analysis, and we already hit the prespecified high bar for statistical significance at this interim analysis.

是的，當然。等所有CARTITUDE-4存活下來。是的，我們和強生公司都對生存效益感到非常興奮。我們也再次諮詢了某些醫生，他們的創新精神讓生存獲益深受鼓舞。請記住，這實際上是我們的第一個中期生存分析，並且在此中期分析中我們已經達到了預先設定的統計顯著性高標準。

So clearly that tells you the magnitude of the benefits in terms of early life on I guess you would have to wait until a later date of any medical meeting to see if we're planning to publish those data on that. But given what we're seeing in car to six trial, I can tell you the enrollment is tracking way ahead of our expectation at this point, even though we only are enrolled our first patient in October of last year, right now, we fully expect that the enrollment of our two six will complete in the year of 2026. So I think that's also a reflection of clinical benefit, the patients and physicians are seeing. And that clarity, I think, helps the enrollment.

如此清楚地告訴您在早期生活方面的好處有多大，我想您必須等到任何醫學會議的晚些時候才能看看我們是否計劃發布這些數據。但考慮到我們在汽車到六項試驗中所看到的情況，我可以告訴你，目前的註冊情況遠遠超出了我們的預期，儘管我們在去年10 月才註冊了第一位患者，但現在，我們完全預計我們的兩個六名患者的註冊將在 2026 年完成。我認為這種清晰度有助於招生。

Justin Zelin, BTIG.

賈斯汀·澤林，BTIG。

Thanks for taking the question. Just on out of spec rates now that the threshold has been relaxed a bit. Can you comment on how rates have decreased?

感謝您提出問題。現在門檻已經放寬了一點，只是超出了規格率。您能評論一下利率是如何下降的嗎？

Thank you for the question of. So it's still very early because as you recall, we received a wider release backed by FDA on April 5, along with the second line label. So at this point, our if you compare the quarterly data the quality of the spec rate in second quarter was slightly lower than the OS. rate in the first quarter. And I might take a little bit more time before we can start to see a more pronounced OS. because as you can imagine, we're in a very early launch of second line.

謝謝你的提問。所以現在還為時過早，因為正如您所記得的，我們在 4 月 5 日收到了 FDA 支持的更廣泛的發布以及二線標籤。因此，在這一點上，如果您比較季度數據，第二季的規格率品質略低於作業系統。第一季的利率。在我們開始看到一個更明顯的作業系統之前，我可能需要更多的時間。因為正如你所想像的，我們正處於二線產品的早期推出階段。

So you shouldn't be surprised to see that it is probably the sickest are on high-risk cytogenetics mutation patients who come online for second line at this point. And therefore, we shouldn't expect to see the full benefit of second line or the wider release back anytime soon, but we should expect to continue to see that trend over time. And I think eventually it will settle down to a point that is 5% to 10% lower than what we had before some enhancement.

因此，您不應驚訝地發現，此時接受二線治療的高風險細胞遺傳學突變患者可能病情最嚴重。因此，我們不應該指望很快就能看到二線或更廣泛的釋放的全部好處，但我們應該期望隨著時間的推移繼續看到這種趨勢。我認為最終它會穩定下來，比我們在進行一些增強之前的水平低 5% 到 10%。

That make sense, thanks for taking my question.

這是有道理的，謝謝你提出我的問題。

Mitchell Kapoor, H.C. Wainwright.

米切爾·卡普爾，H.C.溫賴特。

Thanks for taking the questions. I wanted to ask on the I mentioned earlier of the queue at major medical centers for a second line demand. Are you able to provide a little bit more color on the magnitude of demand that is in the queue. And then also on on treating initially the patients in second line with the highest risk cytogenetics and who are the sickest of in your discussions with physicians on who they like to treat?

感謝您提出問題。我想詢問一下我之前提到的主要醫療中心排隊等候二線的需求。您能否提供更多有關隊列中需求量的資訊？然後，關於最初治療細胞遺傳學風險最高的二線患者以及您與醫生討論他們喜歡治療的患者中病情最嚴重的患者？

Can you tell me a little bit about, you know, would they like to transition all of their patients at this point, it's just a function of supply or is it where they want to test it out in their highest risk cytogenetics patients before migrating into, I guess, more mild restriction?

你能告訴我一些關於他們是否願意在此時轉移所有患者，這只是供應的函數，還是他們想在轉移到最高風險的細胞遺傳學患者之前對其進行測試，我想，更溫和的限制？

Yes, hi, it's Steve. When I take that question, I'll take the last question maybe first, in terms of the patient characteristics, and this is true what we saw during the CARTITUDE-1 launch, and we're seeing it as well in Europe. What you're seeing for all these indications is the sickest of the sick are treated first right. So you're seeing the high risk takers right out of the gate bomb gets filled to sell, and we expect that to also happen with the CARTITUDE-4 launch.

是的，嗨，我是史蒂夫。當我回答這個問題時，我可能會先回答最後一個問題，就患者特徵而言，這就是我們在 CARTITUDE-1 發射期間看到的情況，我們在歐洲也看到了這一點。從所有這些跡像中你看到的是，病情最嚴重的人首先得到治療。因此，您會看到高風險承擔者一開始就充滿了炸彈來出售，我們預計 CARTITUDE-4 的發射也會發生這種情況。

So to a point earlier in earlier lines and were again, our research was was bearing out on that before we launch, we'll see how it goes once we actually see that the true data, but all the data was pointing in high-risk earlier lines that they would be the first candidates out that would be receiving cilta-cel under the new indication. I'm trying to think without what was the other question here.

因此，在早期的某個點上，我們的研究在我們推出之前就已經證實了這一點，一旦我們真正看到真實的數據，我們就會看到它的進展情況，但所有數據都指向高風險早些時候曾表示，他們將是第一批在新適應症下接受cilta-cel 的候選者。我試著思考這裡的另一個問題是什麼。

All physicians, yes, in terms of their how they plan on treating. So that's generally speaking, right? Academic centers, how they're looking at this the, um, the way I look at the market though, is kind of bifurcated by the academics within our sites. But as you know, there's a large referring dynamic for these patients now. So this is where we are deployed with our partner now in the outpatient clinics to work on the referral side of the equation.

是的，所有醫生都計劃如何治療。所以一般來說是這樣，對吧？學術中心，他們如何看待這個問題，嗯，我看待市場的方式，在我們網站內的學術界中存在分歧。但如您所知，這些患者現在有很大的轉診動態。因此，我們現在與我們的合作夥伴一起部署在門診診所，負責轉診方面的工作。

And this is where in the standard risk population. That's the one that we have probably our greatest work, quite frankly, in the earlier lines. These are patients to the point that have a lot of different options. But this is the area that we're currently deployed against to meet with these physicians and educate them and identifying the patients that would benefit the most.

這就是標準風險族群中的情況。坦白說，這可能是我們在早期作品中最偉大的作品。這些患者有很多不同的選擇。但這是我們目前部署的領域，目的是與這些醫生會面並對他們進行教育並確定最受益的患者。

Maybe Mitchell, I'll add that in terms of how they use this right. Again, this is some of the feedback, early feedback from the field. So yes, they are focusing on the roughly 25% of patients in second line who harbor a high-risk strategy that mutation. But that's not the only population, for example, I'm sure you have seen our data presentation at [ASH] call rights.

也許米切爾，我會補充說他們如何使用這項權利。同樣，這是一些回饋，來自該領域的早期回饋。所以，是的，他們正在關注大約 25% 的二線患者，這些患者攜帶著突變的高風險策略。但這並不是唯一的人群，例如，我確信您已經在 [ASH] 認購權中看到了我們的數據演示。

There's a portion of patients what we call the young functional high-risk, which means they may not Harbor cytogenetic mutation, but they actually do progress within 18 months of the first line treatment of those patients are desperate and needing another acute nausea. So that's also another population.

有一部分患者被我們稱為年輕功能性高風險患者，這意味著他們可能不攜帶細胞遺傳學突變，但實際上在一線治療後18 個月內確實取得了進展，這些患者處於絕望狀態，需要再次出現急性噁心。所以這也是另一個人口。

And then lastly, there's a population who is relatively young and these folks are still working. They would like to get the once and done benefits from a CAR-T administration so that they can go back to their normal daily living activities. So those are probably the three buckets of patients that likely will get a CAR-T in the second line at this point. And so that's if you look at the numbers, it's roughly probably 35% of our second-line population if you add those three buckets here.

最後，有一群人相對年輕，而且這些人仍在工作。他們希望從 CAR-T 治療中獲得一次性的好處，以便他們能夠恢復正常的日常生活活動。因此，這些可能是目前可能在第二線接受 CAR-T 治療的三類患者。所以，如果你看一下數字，如果你把這三個部分加在這裡，它大約占我們二線人口的 35%。

Great. Thank you so much for that detail.

偉大的。非常感謝您提供的詳細資訊。

George Farmer, Scotiabank.

豐業銀行的喬治法默。

Hi, good morning. Thanks for taking my questions. A couple from me and let's see now getting back to the 52,000 patient number you threw out there, you're hearing about, you know, potentially the market potential and, you know, you're heavily focused on manufacturing, Spansion, you know, what kind of costs are we looking at and done? And how should we think about putting those numbers in our model in out years out years? That's number one.

嗨，早安。感謝您回答我的問題。我的一對夫婦，讓我們現在回到你在那裡拋出的 52,000 名患者人數，你聽說過，你知道，潛在的市場潛力，你知道，你非常專注於製造，Spansion，你知道，我們正在考慮並完成什麼樣的成本？未來幾年我們應該如何考慮將這些數字放入我們的模型中？這是第一名。

Number two, I was wondering if you could comment on the belantamab results that were published in the New England Journal of Medicine. That's the BCMA ADC. It looks like you had some pretty good activity in frontline would be great to get your perspective on how that data compares to what you've seen with CAR-T.

第二，我想知道您是否可以對《新英格蘭醫學雜誌》上發表的 belantamab 結果發表評論。這就是 BCMA ADC。看起來您在前線進行了一些相當不錯的活動，如果您能了解這些數據與您在 CAR-T 中看到的數據相比如何，這將非常有用。

And then finally, on this overall survival and balance that FDA was pounding on at Kodak now in the early early phases of follow-up, does that ever come up with physicians as in the real world? I'd be helpful to get your comments on that?

最後，關於 FDA 在早期追蹤階段對柯達進行的整體生存和平衡研究，醫生是否像在現實世界中那樣想到過這一點？我會幫助您獲得對此的評論嗎？

Yes, George, thanks for your three-part questions on. So on the first one on in terms of some on capital investment here. So if you look at our capital plans we have decided upon with our partner, J&J, it's roughly $1 billion in total in this round. And our first get us to the 10,000 of those capacity by end of next year and then next about two years after that two to three years after that, with somewhat very incremental investment, we can get to about 20,000 capacity. And then in terms of the on in terms of the additional investment on. So we think that it really depends on which mode we choose. Right?

是的，喬治，謝謝你提出的由三個部分組成的問題。第一個是關於資本投資的。因此，如果你看看我們與合作夥伴強生 (J&J) 共同決定的資本計劃，本輪融資總額約為 10 億美元。我們首先要在明年年底前達到 10,000 個產能，然後再過兩年左右，再過兩到三年，透過一些非常增量的投資，我們可以達到約 20,000 個產能。然後就額外投資而言。所以我們認為這實際上取決於我們選擇哪種模式。正確的？

Is it going to be a greenfield facility we break ground from scratch or is it going to be a brownfield with the existing structure orders, some other modest. So it's a little bit hard to on to say that at this point. But obviously, we don't want to leave those markets done on the table here.

這將是我們從頭開始破土動工的綠地設施，還是將成為具有現有結構訂單的棕地，以及其他一些適度的設施。所以現在說這個有點困難。但顯然，我們不想把這些市場留在談判桌上。

So we are having a very thoughtful discussion with our partner here in terms of how we actually unlock the potential and then tap into the frontline market or maybe even more penetration to secondary market with additional capacity on.

因此，我們正在與我們的合作夥伴進行非常深思熟慮的討論，討論我們如何真正釋放潛力，然後進入一線市場，或者在增加產能的情況下進一步滲透到二級市場。

And then on ATC, I think there was a session right at ASCO, George, if you recall, there are a couple of chaos will discuss the data from T-cell engagers, CAR-T and also ADC. And I think the consensus view from that panel and also through our recent channel checking from doctors in Alberta, is that on really CAR-T is considered to be the first option given the down benefit and also the durability of the response we see, including now survival benefit.

然後在 ATC 上，我想在 ASCO 上有一個會議，喬治，如果你還記得的話，有一些混亂的會議將討論來自 T 細胞參與者、CAR-T 和 ADC 的數據。我認為該小組的共識觀點以及透過我們最近對阿爾伯塔省醫生的管道檢查得出的共識是，鑑於我們所看到的副作用以及反應的持久性，CAR-T 確實被認為是第一選擇，包括現在生存效益。

So I do think there is a position in the market for ATC, but we're not thinking that it will really change the dynamic or the landscape today. And again, we just saw this publication from nature are that's coming from a large on real-world patient study at Mayo Clinic, clearly based on both PFS and overall survival party is better than T-cell engagers and T-cell engagers, a better name, etc.

因此，我確實認為 ATC 在市場上佔有一席之地，但我們並不認為它會真正改變當今的動態或格局。再說一次，我們剛剛看到這篇來自Nature 的出版物，它來自Mayo Clinic 的一項大型真實世界患者研究，顯然基於PFS 和總體生存率，派對優於T 細胞接合者和T 細胞接合者，更好姓名等

I think that some very indisputable results from a large cohort study at Mayo Clinic. I think that speaks volume of the benefit of CAR-T versus the other two modes of action. So we feel really good about the long-term prospect of CapEx this year and based on the benefit we have seen in PFS, OS.

我認為梅奧診所的一項大型隊列研究得出了一些非常無可爭議的結果。我認為這充分說明了 CAR-T 相對於其他兩種作用模式的優勢。因此，基於我們在 PFS、OS 中看到的好處，我們對今年資本支出的長期前景感到非常樂觀。

And then maybe on the last question on the OS imbalance? No, we haven't encountered too many questions in the field on given that data because clearly that's actually before CAR-T was even administered rate and you saw some of that a similar phenomenon in some other CAR-T experiments that some you know, that is a I guess, a phenomena you see in the CAR-T experiments in the clinic.

然後也許是關於作業系統不平衡的最後一個問題？不，鑑於這些數據，我們在該領域並沒有遇到太多問題，因為顯然這實際上是在CAR-T 給藥之前，並且您在一些您知道的其他CAR-T 實驗中看到了類似的現象，我想這就是你在臨床 CAR-T 實驗中看到的現象。

On the other hand, we are doing a lot of work in terms of shrinking the vein-to-vein time. And also today, there is an increasing on our momentum of bridging therapies available to the physicians. So that could also address that issue as well. But in short, no, we're not really encountering a lot of questions asked about that early imbalance.

另一方面，我們在縮短靜脈間時間方面做了很多工作。如今，我們為醫生提供的橋接療法的勢頭不斷增強。所以這也可以解決這個問題。但簡而言之，不，我們並沒有真正遇到很多關於早期不平衡的問題。

Okay, thanks.

好的，謝謝。

Rick Bienkowski, Cantor Fitzgerald.

里克·賓科夫斯基，康托·費茲傑拉。

Hey, good morning and thank you for taking the questions. First, I just wanted to confirm it sounds like the initiation of clinical production by Novartis should immediately free up capacities for commercial production. I was hoping if you could comment on if you do expect to should have an immediate effect on capacity for the third quarter.

嘿，早上好，感謝您提出問題。首先，我只是想確認諾華啟動臨床生產聽起來應該立即釋放商業生產的能力。我希望您能評論一下您是否確實預計會對第三季的產能產生立竿見影的影響。

And my second question, I also just wanted to ask about the downstream effects that an improved spec rate could have on operations. And I guess I'm specifically thinking about cost of goods and how quickly patients get drug on average. I'd like to hear your thoughts on how a 5% to 10% improvement in auto spec rate could impact P&L over time?

我的第二個問題，我也只是想問一下提高規格率可能對營運產生的下游影響。我想我正在特別考慮商品成本以及患者獲得藥物的平均速度。我想聽聽您對汽車規格率提高 5% 到 10% 隨著時間的推移會如何影響損益的看法？

So I'll talk about the first and third question, Rick, on Novartis. Yes, the first batch production initiated last month in the Novartis facility. But as you can imagine, in any CAR-T facility, it's not a hockey stick. It is typically a gradual up tick in current year. So yes, if we have for example, 10 batches on that Novartis are producing for our card to six, then that does free up 10 batch of commercial capacity at route. And so that is the direct impact but I wouldn't say it's a dramatic impact in Q3. So yes, there's definitely some incremental positive impact on that.

Rick，我將討論關於諾華的第一個問題和第三個問題。是的，第一批生產已在上個月在諾華工廠開始。但正如你可以想像的那樣，在任何 CAR-T 設施中，它都不是曲棍球桿。今年通常會逐漸上升。所以，是的，如果我們有，例如，諾華公司正在為我們的卡生產 10 批次，達到 6 批次，那麼這確實會釋放 10 批次的商業產能。這就是直接影響，但我不會說這對第三季產生巨大影響。所以，是的，這肯定會產生一些正面的增量影響。

And then on the third question, on the vein-to-vein time, I can give you the latest data. So in the second quarter on our P90 or 90% of the inspect sample were shipped out within 42 days. That is a freeze to delivery to a shipment. And then if you look at the median, it was about 30 to 35 days, so it's less than six weeks. So we're continuing to make progress in terms of our vein-to-vein time here.

然後關於第三個問題，關於靜脈到靜脈的時間，我可以給你最新的數據。所以第二季我們的P90或說90%的檢驗樣品在42天內就出貨了。這就是凍結發貨。如果你看中位數，大約是 30 到 35 天，所以不到六週。因此，我們將繼續在我們的靜脈間時間方面取得進展。

And then the second part, I'll ask Lori to comment.

然後是第二部分，我會請洛瑞發表評論。

Hi Rick. So in relation to the P&L, as you can imagine, if there is an improvement in the vein-to-vein time. There's an improvement in the US that will help to drive down your COGS. But I can't give you direct definitive on guidance on how much that would improve our COGS. But yes, that would definitely be one of the influences to help bring and drive down our cost of goods sold.

嗨瑞克。因此，就損益而言，正如您可以想像的那樣，如果靜脈間時間有所改善。美國的一項改進將有助於降低您的銷貨成本。但我無法給您直接明確的指導，說明這將在多大程度上改善我們的銷貨成本。但是，是的，這肯定是有助於降低我們的銷售成本的影響之一。

Sean McCutcheon, Raymond James.

肖恩麥卡琴，雷蒙德詹姆斯。

Hi, guys. Thanks for taking the question. And maybe to piggyback off of that last point can you speak to the progress in specific of any additional manufacturing efficiency efforts?

嗨，大家好。感謝您提出問題。也許您可以藉用最後一點來談談任何額外的製造效率努力的具體進展嗎？

And separately, any update around your thinking for MRD as an intermediate endpoint for accelerated approval in your front-line studies?

另外，您對將 MRD 作為加速批准一線研究的中間終點的想法有何更新？

Yes, Sean, this is Lori. I'll take your first question regarding the additional manufacturing efficiencies that you're seeing. That is why you saw in our Q2 earnings, you saw that there was pretty significant improvement over Q1 in our gross margins and as we continue to realize manufacturing efficiencies as we turn on a different note as well that you'll continue to see those costs go down and our gross margins improve on.

是的，肖恩，這是洛瑞。我將回答您關於您所看到的額外製造效率的第一個問題。這就是為什麼您在我們第二季的收益中看到，我們的毛利率比第一季有了相當大的改善，並且隨著我們繼續提高製造效率，我們也會繼續看到這些成本下降，我們的毛利率提高。

As I mentioned before, just to be a transparent, you will see variability in each of the quarters in your gross margin as we bring these additional dose online and we continue to invest in capital, but we saw really good strong gross margins for our product quarter over quarter, and we do expect to continue to see those.

正如我之前提到的，為了透明起見，隨著我們將這些額外劑量上線並繼續投資資本，您會看到每個季度的毛利率都有變化，但我們看到我們產品的毛利率非常好每個季度都如此，我們確實預計會繼續看到這種情況。

Ying do you want to take the second question and frontline?

瑩你想接第二個問題和前線嗎？

Yes, sure. So on given the recent old recommendation, we and our partner to have plans to request a meeting and sit down with the agency to talk about using MRD negativity as a potential registration endpoint. And so if you look at the clinical trial protocol we published on clinicaltrials gov. You will see that in that continue six trial MRD negativity is already on a co-primary endpoint.

是的，當然。因此，根據最近的舊建議，我們和我們的合作夥伴計劃要求召開一次會議，並與該機構坐下來討論使用 MRD 陰性作為潛在的註冊端點。因此，如果您查看我們在臨床試驗政府上發布的臨床試驗方案。您將看到，在接下來的六次試驗中，MRD 陰性已經出現在共同主要終點上。

Now, could we use on just margin activity or a 12-month margin activity as a registration endpoint that remains to be discovered the agency. If the agency agrees, certainly, we would welcome that and that could actually on significantly decreased the time to market entry for cardio six out of the first line indication.

現在，我們是否可以僅使用保證金活動或 12 個月的保證金活動作為註冊端點，這仍有待機構發現。如果該機構同意，我們當然會歡迎這一點，這實際上可能會顯著縮短一線適應症之外的有氧運動六種產品的上市時間。

Konstantinos Biliouris, BMO Capital Market.

Konstantinos Biliouris，BMO 資本市場。

Hi, this is Phil on for Konstantinos. Congrats on the quarter and thanks for taking our questions. So just one question from us regarding the labor, the current coverage to label.

大家好，我是康斯坦丁諾斯的菲爾。恭喜本季度，感謝您提出我們的問題。我們只問一個關於勞工、目前標籤覆蓋範圍的問題。

So on Peter was recently mentioned that FDA may revisit the black box warning on secondary malignancy risk in the CAR-T labels. Given that the notice, the incidence of such risk is order of magnitude lower versus the chemotherapies and with only a few cases will be positive for the consequences and inform us.

Peter 最近提到 FDA 可能會重新審視 CAR-T 標籤中關於繼發性惡性腫瘤風險的黑框警告。鑑於該通知，此類風險的發生率比化療低一個數量級，並且只有少數病例會對後果產生積極影響並通知我們。

So we just wonder if you have any discussion with FDA on label updates that potentially can removed such wording? And also if you can provide any additional color around that topic? It was super helpful.

所以我們只是想知道您是否與 FDA 就可能刪除此類措辭的標籤更新進行了討論？另外，您是否可以圍繞該主題提供任何其他顏色？這非常有幫助。

Thanks for the question. I think last time when some of the SPM. on label was updated, it was a class label. So basically FDA put in very similar, if not the same language in our six commercial CAR-T savo. So we probably expect that potentially if there's any change that might be a cost level as well, but I wouldn't want to speculate on that at this point because we have not have any detailed discussion with the agency about that. I think everything will be guided by the clinical data and also in the real world of data collection as well.

謝謝你的提問。我想起上次SPM時的一些。標籤已更新，它是一個類別標籤。所以基本上 FDA 在我們的六種商業 CAR-T savo 中使用了非常相似的語言，即使不是相同的語言。因此，我們可能預計，如果有任何變化，也可能是成本水平，但我目前不想對此進行推測，因為我們尚未與該機構就此進行任何詳細討論。我認為一切都將以臨床數據以及數據收集的現實世界為指導。

But regardless, we continue to believe that given the small incidence of those SPM and also the large clinical benefit we observed in both the clinical trials and also in the real world. We continue to believe there's a very strong benefit over risk here. And so that also has not been really a big concern from prescribing physicians either because, as you know in the field of multiple myeloma, this SPM issue has been out there for decades and physicians know very much about there's some adverse events associated with some of the treatments.

但無論如何，我們仍然相信，鑑於這些 SPM 的發生率很小，而且我們在臨床試驗和現實世界中觀察到了巨大的臨床益處。我們仍然相信這裡的收益遠大於風險。因此，這也不是處方醫生真正關心的問題，因為正如您所知，在多發性骨髓瘤領域，這種SPM 問題已經存在了幾十年，而且醫生非常清楚，某些不良事件與某些藥物相關。

And I mean, just to call to one physician, we have discussed this topic with he said, Oh, I am in no way to Mark focused and concerned about treating the cancer the patient has rather than worrying about what other cancer the patient may have later.

我的意思是，只是打電話給一位醫生，我們討論了這個話題，他說，哦，我絕不會讓馬克專注於治療患者患有的癌症，而不是擔心患者可能患有其他癌症之後。

Thank you.

謝謝。

Asthika Goonewardene, Truist.

Asthika Goonewardene，真理主義者。

Hey, guys, good morning. Thanks for taking my question and congrats on the progress being made here and the question of going back to the onboarding process, the new 80 series on Gilead talks about making a strong push to a some of those larger community centers and in that in your target of 100 agencies by year end and what do we have for 2025?

嘿，夥計們，早安。感謝您提出我的問題並祝賀這裡取得的進展以及回到入職流程的問題，吉利德的新 80 系列討論了大力推動一些較大的社區中心以及您的目標到年底將有100 家代理機構，2025年我們有什麼？

I wanted to get your thoughts on how you're thinking about targeting some of these larger community centers, more what mix there would be. Obviously you want to have the academics, but what makes with these larger community centers is can your priority list and what impact that would have on the inpatient side of things?

我想了解您如何考慮針對這些較大的社區中心，以及更多的組合。顯然，您希望擁有學者，但這些較大的社區中心的特點是您的優先事項清單以及這會對住院方面產生什麼影響？

Thanks, it's Steve. Why don't I take that question. Thanks for bringing that up because that's an important part of the strategy for for this brand. So as you said, we're basically deployed today and into the near term in our major academic centers. However, we are running pilots today as well, where our major academic centers are partnering with their community referring centers to basically offload some of the capacity constraints that they have at the site level.

謝謝，我是史蒂夫。為什麼我不回答這個問題。感謝您提出這一點，因為這是該品牌策略的重要組成部分。正如您所說，我們今天和短期內基本上已部署在我們的主要學術中心。然而，我們今天也在進行試點，我們的主要學術中心正在與他們的社區推薦中心合作，以基本上減輕他們在站點層面的一些容量限制。

So we are already engaged in some pilot activity through our academic centers where they're working very closely with their community affiliates. So that is that's been ongoing and that's been ongoing for the better part of a year because you're right, as we start moving into that early second line, which we are today, and we'll continue to broaden out our commercial footprint to include not only the large academic centers, but also with those centers to bring onboard the community of affiliates of that.

因此，我們已經透過我們的學術中心進行了一些試點活動，他們與社區附屬機構密切合作。所以這一直在持續，並且已經持續了一年的大部分時間，因為你是對的，當我們開始進入早期的第二條線時，我們今天就是這樣，我們將繼續擴大我們的商業足跡不僅包括大型學術中心，也包括那些將其附屬機構社區納入其中的中心。

So it's very important that we bring on the academics with us as a because then it's much more coordinated. And obviously, the key thing for us is always keeping patient safety first. So we want to make sure that we do that in accordance with our large academics.

因此，讓學者參與其中非常重要，因為這樣會更協調。顯然，對我們來說最重要的是始終將病人安全放在第一位。因此，我們希望確保我們按照我們的大型學術機構的要求來做到這一點。

And then finally, the third leg of our strategy is that the right point in time because there was some earlier conversation around Frontline is ultimately getting out into the clinic. And that's something downstream that we've had some initial conversations with some of the large retail clinic providers out there to see and then better understand what is their role and how does that dovetail with the role of the community hospitals as well as their referring large academic centers.

最後，我們策略的第三條腿是正確的時間點，因為之前圍繞 Frontline 進行了一些對話，最終將進入診所。這是下游的事情，我們與一些大型零售診所提供者進行了一些初步對話，以了解並更好地了解他們的作用以及這與社區醫院的作用以及他們所轉診的大醫院的作用如何相吻合。

So that's something forthcoming. It's something something that would be will be rolling out over the next couple of years as we prepare the market for our launch in frontline.

這就是即將發生的事情。當我們為我們在一線的推出做好市場準備時，這將在未來幾年內推出。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。