Autolus Therapeutics PLC (AUTL) 2024 Q4 法說會逐字稿

Hello ladies and gentlemen and welcome to the Autolus Therapeutics call to discuss its full year 2024 financial results and business updates. As a reminder, this conference call is being recorded.

女士們、先生們，大家好，歡迎參加 Autolus Therapeutics 電話會議，討論其 2024 年全年財務業績和業務更新。提醒一下，本次電話會議正在錄音。

I would now like to turn the conference over to your host, Amanda Cray. Please go ahead.

現在我想將會議交給主持人阿曼達·克雷 (Amanda Cray)。請繼續。

Thank you, Latonya. Good morning or good afternoon, everyone, and thank you for joining us on today's call. With me, our Chief Executive Officer, Dr. Christian Itin, and Chief Financial Officer, Rob Dolski.

謝謝你，拉托尼亞。大家早安或下午好，感謝您參加今天的電話會議。和我一起的還有我們的執行長 Christian Itin 博士和財務長 Rob Dolski。

I'd like to remind you that during today's call, we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1,995.

我想提醒您，在今天的電話會議上，我們將根據聯邦證券法和 1995 年《私人證券訴訟改革法案》的安全港條款做出與我們業務相關的前瞻性聲明。

These may include, but are not limited to statements regarding status of the ongoing commercial launch of a castle in the US, Autolus manufacturing, sales and marketing plans for AUCATZYL. The market potential for AUCATZYL and the status of clinical trials and development and or regulatory timelines for obe-cel and our other product candidates. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statement.

這些可能包括但不限於有關美國城堡正在進行的商業發布的狀態、Autolus 製造、AUCATZYL 的銷售和行銷計劃的聲明。AUCATZYL 的市場潛力以及 obe-cel 和我們其他候選產品的臨床試驗和開發狀態和/或監管時間表。這些聲明受各種風險和不確定性的影響，可能導致實際結果與預期有重大差異，並且僅反映我們截至今天的觀點。我們不承擔更新任何此類前瞻性聲明的義務。

For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and in our SEC filings, both available on the investor section of our website.

有關可能影響我們實際結果的重大風險和不確定性的討論，請參閱今天的新聞稿和我們的美國證券交易委員會文件中確定的風險，這兩份文件都可以在我們網站的投資者部分找到。

On slide 3, you'll see the agenda for today's call. As usual, Christian will provide an overview of our operational highlights.

在投影片 3 上，您將看到今天電話會議的議程。與往常一樣，克里斯蒂安將概述我們的營運亮點。

Rob will then discuss the financial results, and Christian will conclude with upcoming milestones and closing remarks. We will then take your questions. With that, I'll turn it over to Christian.

隨後，羅布將討論財務結果，克里斯蒂安將總結即將到來的里程碑並發表結束語。然後我們將回答您的問題。說完這些，我就把話題交給克里斯蒂安。

Thank you very much, Amanda, and welcome everybody to our fourth quarter 2024 financial results update. So first off, obviously, we had a very successful 2024 which sets us up well for the 2025 that we're already in, a few months now. First of all, I'd like to just highlight kind of the key objectives that we have for the year.

非常感謝，阿曼達，歡迎大家關注我們 2024 年第四季的財務業績更新。首先，顯然我們在 2024 年取得了非常大的成功，這為我們幾個月前就已經進入的 2025 年做好了準備。首先，我想強調我們今年的主要目標。

So the primary objective clearly is to execute a successful commercial launch for AUCATZYL, and we're doing really well and advancing well on that. We'll provide a bit of an update as we go through the presentation.

因此，主要目標顯然是成功實現 AUCATZYL 的商業發布，我們在這方面做得非常好，進展順利。在演示過程中，我們將提供一些更新資訊。

But also we see a lot of opportunity for obe-cel to actually expand its utility, the excellent profile that we've seen in our prior in our current experience with the product, and explore the opportunity and additional indications as well as look at the opportunity for moving some of our other product candidates forward and at the same time, obviously we'll be, I think, very selective and very careful in how we're going to place our investments.

但我們也看到 obe-cel 有很多機會可以真正擴大其實用性，我們在先前的產品體驗中看到了它的出色表現，並探索機會和其他適應症，以及尋找推動其他一些候選產品向前發展的機會，同時，顯然，我認為，我們會非常謹慎和謹慎地進行投資。

Now one of the things that you'll hear us also briefly mention is the fact that we're planning for an R&D event on April 23rd in New York that will actually outline in more detail kind of the plans on how we want to move forward in sort of creating additional opportunities for future growth. So, with that on slide on the next slide. I'm briefly going to summarize kind of the key opportunities that we have seen and sort of achieved during the course of 2024.

現在，您會聽到我們簡要提到的一件事是，我們計劃於 4 月 23 日在紐約舉辦研發活動，該活動將更詳細地概述我們希望如何向前邁進以創造未來增長的更多機會的計劃。因此，請在下一張投影片上繼續討論這一點。我將簡要總結我們在 2024 年期間看到並實現的關鍵機會。

As I mentioned, this has been a remarkably successful year and we had a very strong start of the year in the first quarter when we were able to add about $600 million to our balance sheet through our collaboration with BioNTech as well as a public financing that we conducted in the first quarter. This set us up very well to really be able to focus fully on making sure that we get obe-cel already and to get through the approval process in the US, but also to set us up well for the commercial launch of the product.

正如我所提到的，這是非常成功的一年，我們在第一季有一個非常強勁的開局，透過與 BioNTech 的合作以及我們在第一季度進行的公開融資，我們的資產負債表增加了約 6 億美元。這讓我們能夠完全集中精力確保我們已經獲得 obe-cel 並通過美國的審批程序，同時也為該產品的商業化發布做好了準備。

As we're going through the year, I would say we have continuous activities on the commercial side to actually get the sites ready so that they actually would be in a position once the product was approved to actually start onboarding the product and be in a position to move forward and actually use the product in the commercial space.

在我們度過這一年的過程中，我想說我們在商業方面持續開展活動以真正讓站點做好準備，以便一旦產品獲得批准，他們實際上就可以開始使用該產品，並能夠繼續前進並在商業領域實際使用該產品。

Now when we look at the approval itself, we achieved the approval in the US on November 8th. And I think what was very encouraging was that it not only did we actually achieve the approval slightly ahead of schedule, but also actually had a label which gives us a broad opportunity in the relapsory factory ALL space for adult patients and not and actually having the first product getting through the approval process that actually did not require a REMS program.

現在我們來看批准本身，我們在 11 月 8 日在美國獲得了批准。我認為非常令人鼓舞的是，我們不僅實際上提前獲得了批准，而且實際上還獲得了一個標籤，這為我們在復發工廠 ALL 領域為成年患者提供了廣闊的機會，並且實際上是第一個通過審批流程的產品，實際上並不需要 REMS 計劃。

So very nice setup in terms of the approval itself, the timing of the approval itself, not having a delay, recognizing that the product had an attractive safety profile and therefore no obligation for collecting additional information around CRS and ICANS going forward and that actually is, I think, a very strong foundation.

因此，就批准本身、批准時間本身而言，這是一個非常好的設置，沒有延遲，承認該產品具有吸引人的安全性，因此沒有義務收集有關 CRS 和 ICANS 的其他信息，我認為這實際上是一個非常堅實的基礎。

What was then very helpful is that we were able to actually get the clinical results published in the New England Journal of Medicine in the early part of December, and shortly thereafter, the product was included in the NCCN guidelines. This is very important as you start launching a product because it gives us a lot of confidence and indeed this is a recommended therapy and also will support the decisions that payers have to obviously go through to get the patients signed off for commercial use.

當時非常有幫助的是，我們能夠在 12 月初將臨床結果發表在《新英格蘭醫學雜誌》上，此後不久，該產品就被納入 NCCN 指南。當您開始推出產品時，這一點非常重要，因為它給了我們很大的信心，而且這確實是一種推薦的療法，並且還將支持付款人必須做出的決定，以使患者同意用於商業用途。

Now when we look at the track that we had as we went through the first three months of the launch, we see a very good development in terms of the number of centres that are actually authorized and are able to deliver the product. We're currently showing 33 centres that are authorized as of March 19th, and we expect that that group of centres allows us to reach approximately 60% of the target patient population in the US.

現在，當我們回顧推出後的前三個月所取得的進展時，我們看到實際獲得授權並能夠交付產品的中心數量取得了非常好的發展。我們目前顯示截至 3 月 19 日已獲得授權的 33 家中心，我們預計這些中心可以讓我們覆蓋美國約 60% 的目標患者群體。

We are continued to move forward, adding additional centres as we go through this year. By the end of the year, expect to have approximately 60 centres that'll be, ready and, in a position to deliver, or cancel to patients. We believe that those 60 centres, actually reached the vast majority of the patients, in the US and will give us a very strong foundation, for a successful delivery of the product to, the, patient, patients across the US.

我們將繼續前進，在今年增加更多的中心。到今年年底，預計將有大約 60 個中心做好準備並能夠為患者提供服務或取消服務。我們相信，這 60 個中心實際上已經涵蓋了美國絕大多數患者，並將為我們成功地將產品交付給美國各地的患者奠定非常堅實的基礎。

Already mentioned that we obviously have the publication of the of the study of the FELIX study in the New England Journal, but we're also in addition to obviously getting ready for launch in the US We're also moving through the regulatory steps in the UK and in Europe and had filed in the early part of 2024 with the image with EMA and then by the middle of the year with the MHRA, and we expect actually regulatory decisions in the second half of 2025.

已經提到，我們顯然已經在《新英格蘭雜誌》上發表了 FELIX 研究的研究成果，但除了顯然準備在美國推出之外，我們還在英國和歐洲推進監管步驟，並於 2024 年初向 EMA 提交了圖像申請，然後在年中向 MHRA 提交了圖像申請，我們預計實際監管決定將在 2025 年下半年做出。

We also started the process to actually establish ultimately the utility of the product in the UK and we're going through the assessment by the National Institute for Health and Care Excellence or NICE, which is one of the key processes that you have to run through, to get to a position, to actually get a product adequately reimbursed, in the UK.

我們也啟動了最終確定該產品在英國的實用性的流程，我們正在接受英國國家健康與臨床優化研究所 (NICE) 的評估，這是在英國獲得產品充分報銷必須經歷的關鍵流程之一。

As we went through the year, there were several data presentations at key conferences that really focused on the properties that we have observed with a capsule or obe-cel in the relapsed refractory adult population as we were going through and sort of actually gained more and more data from the FELIX study.

在這一年中，我們在幾個重要會議上進行了多次數據展示，這些展示真正側重於我們在復發難治性成年人群中使用膠囊或 obe-cel 所觀察到的特性，並且實際上從 FELIX 研究中獲得了越來越多的數據。

We could report on the durability of the product, highlighted the safety profile, the impact of having deep molecular responses and persistence as indicators and likely requirements to get to long term outcomes with the patients.

我們可以報告產品的耐用性，強調安全性、深度分子反應和持久性的影響作為指標以及獲得患者長期結果的可能要求。

And we're also actually were able to show the impact of tumor burden-guided dosing as well as the safety profile's impact on reducing health economic cost when we look at the cost of treating the patients. So quite a comprehensive data set that we actually were able to share across a range of conferences during the course of last year, including the Tandem meeting in February this year.

當我們考慮治療患者的成本時，我們實際上也能夠顯示腫瘤負擔指導劑量的影響以及安全性對降低健康經濟成本的影響。因此，我們實際上能夠在去年的一系列會議上分享相當全面的數據集，包括今年 2 月的 Tandem 會議。

Moving to the next slide, we're looking briefly here at some of the key outcomes that were actually presented and published in the New England Journal publication, and what we're seeing is that the product has a very high level of clinical activity reaching deep molecular responses in the majority of the patients.

轉到下一張投影片，我們在這裡簡要介紹一下《新英格蘭雜誌》上實際介紹和發表的一些關鍵結果，我們看到該產品具有非常高的臨床活性，在大多數患者中達到了深層分子反應。

And that type of activity obviously has come with an attractive safety profile and we can see that overall the level of high grade cytokine release syndrome and the level of high grade neurological toxicity or ICANS are low. In fact, when we look at patients that have low levels of disease burden at the time of dosing, those patients did not experience high grade events either CRS or ICANS, which I think gives us a good understanding of patient profile and also kind of from a safety perspective.

這種類型的活動顯然具有有吸引力的安全性，我們可以看到，總體而言，高級細胞因子釋放綜合徵的水平和高級神經毒性或 ICANS 的水平較低。事實上，當我們觀察服藥時疾病負擔較低的患者時，這些患者並沒有經歷 CRS 或 ICANS 等高級別事件，我認為這讓我們能夠很好地了解患者的狀況，並且從安全角度來看也是如此。

And as we're looking at the next slide, we also see that the tumor burden also actually gives us important information about the impact of the therapy it can have in terms of longer term outcome. In this slide, we're looking at event free survival. As you can see in the top part of the panel, event free survival stabilizes at around between 45% and 50%.

當我們看下一張投影片時，我們也會看到腫瘤負荷實際上也為我們提供了有關治療對長期結果的影響的重要資訊。在這張幻燈片中，我們正在研究無事件生存。正如您在面板頂部看到的，無事件存活率穩定在 45% 到 50% 之間。

And we see that the line actually is starting to go horizontal, indicating that there is a proportion of patients that do not actually seem to progress or actually have, events that are occurring. When we look at, what the impact is of the disease burden prior to dosing, we can see that patients that have low disease burden, less than 5%, do remarkably well, whereas most patients with a wide range of disease burden, up to 75% actually continued to do very well and only the patients that had extremely high levels of disease burden of more than 75% of two of blasts in the bone marrow at the time of dosing obviously have a lower outcome.

我們看到這條線實際上開始變成水平線，表明有一部分患者的病情實際上似乎沒有進展，或者實際上沒有發生任何事件。當我們觀察服藥前疾病負擔的影響時，我們可以看到，疾病負擔較低（低於 5%）的患者表現非常好，而大多數疾病負擔範圍較廣（高達 75%）的患者實際上仍然表現得很好，只有服藥時疾病負擔極高（骨髓中兩個原始細胞超過 75%）的患者的結果明顯較差。

So overall I think gives us a lot of information about the properties of the product. We have just talked about the safety that we've seen across the Board, the obviously the efficacy from an event free survival across the Board, which looks very attractive. And also there are the impact of actually treating patients when the disease burden is still at a lower level, which gives us a very good, prognosis for these patients.

所以總的來說，我認為這為我們提供了有關產品屬性的大量資訊。我們剛剛討論了我們所看到的全面安全性，顯然，全面無事件生存的功效看起來非常有吸引力。而且，當疾病負擔仍處於較低水平時，對患者進行實際治療也會產生影響，這為我們提供了對這些患者的非常好的預後。

When we look in the next slide, we see that translating into overall survival, and we see the same overall picture again stabilization of overall survival in the overall population and as well an impact that we see in terms of tumor burden where patients again with lower tumor burden and lymphodepletion and also patients with extremely high levels of tumor burden actually have a poorer outlook.

當我們看下一張幻燈片時，我們會看到這轉化為總體生存率，我們再次看到相同的總體情況，即整個人群的總體生存率趨於穩定，同時我們還看到腫瘤負擔方面的影響，其中腫瘤負擔較低和淋巴細胞耗竭的患者以及腫瘤負擔極高的患者實際上前景較差。

Overall remarkable set of data and I think sets us up, for a very attractive proposition for patients in this field.

總體而言，這是一組非常出色的數據，我認為它為我們提供了對該領域患者非常有吸引力的建議。

Moving to the next slide as we're sort of thinking about sort of the early momentum, of the launch in the US, indicators here is the centres that can actually actively deliver products to patients. As I mentioned, we reached 33 centres on the 19th of March, which gives us obviously a very good reach and distribution already across the US and obviously a presence in a lot of the more densely parts of the populated parts of the US, which is also the reason why we're already reaching more than 60% or around 60% of the patient population.

轉到下一張投影片，我們正在考慮在美國推出該產品的早期勢頭，這裡的指標是可以真正主動地向患者提供產品的中心。正如我所提到的，我們在 3 月 19 日已經涵蓋了 33 個中心，這顯然使我們在全美範圍內具有了很好的覆蓋範圍和分佈，並且顯然在美國人口較為密集的地區都有業務，這也是我們已經覆蓋了 60% 以上或 60% 左右患者群體的原因。

What's also important is we're making good progress in terms of patient access, in terms of lives covered, and we see actually very good momentum there as well as we go through the have been going through the last three months. So that is very encouraging and also actually is a good sign that indeed patients do have really an opportunity here to get access to this therapeutic option.

同樣重要的是，我們在患者就醫、覆蓋人群方面取得了良好進展，而且我們看到了非常好的發展勢頭，就像我們過去三個月經歷的那樣。這非常令人鼓舞，實際上也是一個好兆頭，表明患者確實有機會獲得這種治療選擇。

Finally, on the next slide on the update, you have heard us actually talk quite a bit about the actual manufacturing facility for commercial supply, which is the nuclear facility. I think one of the remarkable things about this field is obviously as you have the first commercial patient coming, that's when you literally start the operation at that facility.

最後，在更新的下一張投影片中，您已經聽到我們實際上談論了很多有關商業供應的實際製造設施，即核設施。我認為這個領域的一個顯著特徵是，當你迎來第一位商業患者時，你就可以真正在該設施開始手術。

And I think at this point we can say that we had, we're off to a really good start and the facility came to life and is humming well and I think will be a very strong, give us a very strong foundation in our ability to reliably deliver product to the centres.

我認為現在我們可以說，我們已經有了一個非常好的開始，設施已經投入使用並且運作良好，我認為這將是一個非常強大的基礎，為我們可靠地向中心提供產品的能力奠定了非常堅實的基礎。

So with that, on the next slide, which is really focusing on the expansion of the obe-cel opportunity, a key area that obviously we're going to be focusing on in 2025. First off, on the autoimmune side, we've been running obviously the CARLYSLE study. We have, the initial cohort that we, of six patients that are all dosed. We're running through the data [cut], for the upcoming R&D event on April 23rd, and we're looking forward to updating you on that initial experience, with the first six patients.

因此，下一張投影片將真正關注 obe-cel 機會的擴展，這顯然是我們將在 2025 年重點關注的關鍵領域。首先，在自體免疫方面，我們顯然一直在進行 CARLYSLE 研究。我們最初的隊列中有六名患者，均已服藥。我們正在為即將於 4 月 23 日舉行的研發活動整理數據，並期待向您介紹前六名患者的初步體驗。

And we're also are planning to present the data with long term follow up, across the patients at a later point in the second half of the year. On the Oncology side, obviously we're also have been moving forward with our pediatric study, the PY01 study, and we expect to provide an update also second half of the year that study is also has been envolving very nicely.

我們也計劃在今年下半年稍後公佈針對患者的長期追蹤數據。在腫瘤學方面，顯然我們也在推進兒科研究 PY01 研究，我們預計在今年下半年提供更新信息，該研究的進展也非常順利。

In terms of the early pipeline, we obviously have a set of activities ongoing, with our partners at the University College London, and we are, moving forward or have been active in, AUTO1/22, AUTO6NG and AUTO8, and we continue to progress, the activities around those programs, collecting more information around the programs and are planning tools to give a short update at the R&D day, at the, end of, towards the end of April.

就早期管道而言，我們顯然正在與倫敦大學學院的合作夥伴開展一系列活動，我們正在推進或已經積極參與 AUTO1/22、AUTO6NG 和 AUTO8，我們將繼續推進圍繞這些項目的活動，收集更多有關這些項目的信息，併計劃在 4 月底的研發日上提供簡短的更新。

So with that, I'd like to actually hand over to Rob and give us a summary of the financial results.

因此，我想將時間交給 Rob，並向我們提供財務結果的摘要。

Thanks, Christian, and good morning or good afternoon everyone. It's my pleasure to review our financial results for the full year 2024.

謝謝，克里斯蒂安，大家早安或下午好。我很高興回顧我們 2024 年全年的財務表現。

Cash equivalents and marketable securities at year end 2024 totalled $588 million as compared to $239 million at the December 31st, 2023, time frame. This increase was primarily a result of our strategic collaboration with BioNTech and concurrent equity financing for a combined $600 million in gross proceeds to bolster the balance sheet ahead of our US commercial launch for AUCATZYL.

2024 年底的現金等價物和有價證券總額為 5.88 億美元，而 2023 年 12 月 31 日為 2.39 億美元。這一成長主要得益於我們與 BioNTech 的策略合作以及同時進行的股權融資，共獲得 6 億美元的總收益，以增強我們在美國推出 AUCATZYL 之前的資產負債表。

Loss from operations for the year ending December 31, 2024 was $241.4 million as compared to $179.7 million for the year end in 2023. Cost of sales totalled $11.4 million following the BLA approval for obe-cel.

截至 2024 年 12 月 31 日止年度的營業虧損為 2.414 億美元，而 2023 年末的營業虧損為 1.797 億美元。obe-cel 獲得 BLA 批准後，銷售成本總計 1,140 萬美元。

This amount represents the cost of commercially available plant capacity that can no longer be classified as R&D expense as of November 8th, obe-cel approval date, even though it was not associated with product sales in the fourth quarter.

該金額代表自 obe-cel 批准日期 11 月 8 日起不再歸類為研發費用的商業可用工廠產能成本，即使它與第四季度的產品銷售無關。

Our research and development expenses increased to $138.4 million for the year end in December 31, 2024 compared to $130.5 million in the same period 2023. This change was primarily driven by increases in employee salaries, related costs, manufacturing costs related to obe-cel, and then partly offset some by some decreases in professional fees and facility costs.

截至 2024 年 12 月 31 日，我們的研發費用已增至 1.384 億美元，而 2023 年同期為 1.305 億美元。這項變更主要是由於員工薪資、相關成本、與 obe-cel 相關的製造成本的增加所致，而專業費用和設施成本的下降則部分抵銷了部分影響。

Our selling general and administrative expenses increased to $101.1 million for the year compared to 46.7 for the same period in 2023. This increase was primarily due to the salaries, other employee related costs driven by the overall increase in headcount supporting commercialization activities.

我們的銷售、一般及行政開支今年增至 1.011 億美元，而 2023 年同期為 4,670 萬美元。這一增長主要是由於支持商業化活動的員工總數總體增加所致的工資和其他員工相關成本。

And finally, net loss was $220.7 million for the year ending December 31, 2024, compared to $208.4 million for the same period in 2023. With the recent approval of AUCATZYL in the US, I'd also like to note two financial milestones that were triggered in the fourth quarter.

最後，截至 2024 年 12 月 31 日的年度淨虧損為 2.207 億美元，而 2023 年同期為 2.084 億美元。隨著 AUCATZYL 最近在美國獲得批准，我還想指出第四季度觸發的兩個財務里程碑。

As a result of the FDA approval, Autolus received a $30 million milestone payment from Blackstone based on the terms of our previously announced Blackstone collaboration agreement. In addition, the company made a regulatory milestone payment of GBP10 million in accordance with our UCLB license agreement.

由於 FDA 批准，Autolus 根據我們先前宣布的 Blackstone 合作協議條款從 Blackstone 獲得了 3000 萬美元的里程碑付款。此外，該公司根據我們的 UCLB 許可協議支付了 1000 萬英鎊的監管里程碑付款。

These are both detailed, more specifically in our 10-K filing. We continue to believe that with our current cash equivalents, and marketable securities, we are well capitalized to drive the full launch and commercialization of obe-cel and relapse refractory adult ALL as well as to advance our pipeline development plans, which includes adequate runway to reaching data in the first pivotal study of obe-cel in the autoimmune disease. And as Christian noted, we look forward to providing further detail on these plans at our upcoming R&D event.

這些都很詳細，更具體地說在我們的 10-K 文件中。我們始終相信，憑藉我們現有的現金等價物和有價證券，我們擁有充足的資金來推動 obe-cel 和復發難治性成人 ALL 的全面推出和商業化，並推進我們的管道開發計劃，其中包括在自身免疫性疾病中 obe-cel 的首個關鍵研究中獲取數據的充足跑道。正如克里斯蒂安所說，我們期待在即將舉行的研發活動中提供有關這些計劃的更多細節。

I'll now hand back to Christian to wrap up with a brief outlook on expected milestones.

現在我將把發言權交還給克里斯蒂安，讓他對預期的里程碑做一個簡短的展望。

Thank you very much, and moving to the upcoming milestones, so when we look into, 2025, we are starting the year with, also the update on the SLE1 CARLYSLE study, which we are planning to provide on April 23rd at the R&D company R&D event in New York. We then, when we look at the pediatric study, expect to provide the update on the pediatric study second half of the year, as well as obviously longer term follow up on the CARLYSLE study as well second half of the year.

非常感謝，接下來是即將到來的里程碑，當我們展望 2025 年時，我們也將從 SLE1 CARLYSLE 研究的更新開始，我們計劃於 4 月 23 日在紐約的研發公司研發活動上提供該更新。然後，當我們研究兒科研究時，我們期望在下半年提供兒科研究的最新進展，以及對下半年 CARLYSLE 研究的長期追蹤。

And we do expect also during the second half that we received the notifications around the regulatory process for the UK as well as for the EU regarding potential approvals in those two jurisdictions for obe-cel.

我們確實預計，在下半年，我們將收到有關英國和歐盟監管流程的通知，以了解這兩個司法管轄區對 obe-cel 的潛在批准。

So I think a very interesting year for us in terms of the progression of opportunity that we're actually starting to execute on. We're outlined at the company R&D day, but then also obviously we'll be able to provide more and more evidence and projections as well with regards to the launch progress that we're making for a castle in the US. So, with that, we're happy to take questions and we'll take over I hand over to the operator.

因此，我認為，就我們實際開始執行的機會的進展而言，這對我們來說是非常有趣的一年。我們在公司研發日進行了概述，但顯然，我們也能夠提供越來越多的證據和預測，關於我們在美國城堡的發布進展。因此，我們很樂意回答問題，然後我會將問題交給接線員。

(Operator Instructions)

（操作員指示）

James Shin, Deutsche Bank.

德意志銀行的詹姆斯辛 (James Shin)。

Hey, good morning, guys. Thank you for the question.

嘿，大家早安。謝謝你的提問。

On AUCATZYL launch, and I know it's a progressively evolving situation. Can you provide any color on the initial demand or the book of orders thus far?

在 AUCATZYL 推出時，我知道這是一個逐漸演變的情況。您能否提供有關初始需求或迄今為止的訂單的任何資訊？

And then secondly, Oncologists have mentioned that the split dosing and the delayed onset of CRS AUCATZYL can be useful for outpatient administration. Can you say whether outpatient use is happening or planned thus far?

其次，腫瘤學家提到，CRS AUCATZYL 的分次給藥和延遲起效對於門診給藥很有用。您能否透露一下目前門診使用情況是否正在進行或計劃進行？

And I'll just leave it there.

我就把它留在那裡。

Yeah, well, first of all, thanks a lot for joining, James. On the launch, I think what we can say is that we have also seen a very nice dynamic around the actual activation of the centres, which is really critical and it's very much driven by the level of interest and enthusiasm by the centres to actually do that work and actually and get the product active.

是的，首先，非常感謝你的加入，詹姆斯。關於發布會，我想我們可以說的是，我們也看到了圍繞中心實際激活的非常好的動態，這是非常關鍵的，並且很大程度上取決於中心對實際開展這項工作和實際激活產品的興趣和熱情程度。

That also is often driven by actually having patients that are in need of therapy, which is sort of usually actually the key driver in that in that process. So I think that gives you gives us a very good level of confidence in terms of the how the product is viewed, the level of interest, and I think the dynamic we've been seeing has been very encouraging.

這也常常是由實際有需要治療的患者所驅動的，這通常是過程中的關鍵驅動因素。因此，我認為這讓我們對產品的看法、興趣程度非常有信心，而且我認為我們所看到的動態非常令人鼓舞。

Obviously we provide a obviously a fuller picture at the Q1 update, but I think what we can say is that we see a very good dynamic and I think a very significant level of interest and I think a recognition that the product has attractive properties for these patients. With regards to the outpatient, question.

顯然，我們在第一季的更新中提供了更全面的圖景，但我認為我們可以說的是，我們看到了非常好的動態，我認為人們的興趣程度非常高，而且我認為人們認識到該產品對這些患者俱有吸引人的特性。關於門診，有疑問。

I think there is an opportunity, as you've seen from the safety data that I highlighted during the presentation, is that patients that have very low levels of tumor burden and lymphodepletion tend to have a very limited amount of immunological safety events.

我認為存在一個機會，正如您從我在演講中強調的安全數據中看到的那樣，腫瘤負擔和淋巴細胞清除水平非常低的患者往往具有非常有限的免疫安全事件。

And I think that is certainly attractive and has led to a number of physicians to suggest that they might be interested to actually explore and possibly to administer the product in a sort of a hospital outpatient setting. We'll need to see how that evolves. A lot of that has to do with the actual experience gained with the product on the commercial setting and the confidence physicians are building up and I think we'll see that evolve over the upcoming of the upcoming periods.

我認為這確實很有吸引力，並且已經導致許多醫生表示他們可能有興趣實際探索並可能在醫院門診環境中使用該產品。我們需要觀察其如何發展。這在很大程度上與產品在商業環境中獲得的實際經驗以及醫生正在建立的信心有關，我認為我們將在未來一段時間內看到這種情況的發展。

I don't think at this point in time I think we can guide you in any way at this point. I think it's too early in the launch, but it's clearly an observation that a number of the physicians certainly have made, and it will be interesting to sort of follow that as we go through the year.

我認為目前我們無法以任何方式指導您。我認為現在推出還為時過早，但這顯然是許多醫生做出的觀察，隨著我們度過這一年，跟踪這一觀察將會很有趣。

Rajan Scharma, Goldman Sachs.

高盛的拉詹·沙爾瑪（Rajan Scharma）。

Hi, thanks for, taking my questions.

你好，謝謝你回答我的問題。

It's just a couple of logistics actually. So, obviously you have the target to have 60 authorized centres, by the end of the year. We're just interested in the ramp to get to that from where you are right now. Should we expect that to be linear or are they kind of could this potentially come in in blocks of centres coming online.

實際上這只是一些後勤事務。因此，顯然你們的目標是在今年底擁有 60 個授權中心。我們只是對從您現在所在位置到達那裡的坡道感興趣。我們是否應該預期這是線性的，或者這是否有可能以中心上線的方式出現。

And then the second one just on tariffs actually that's obviously been a focus for investors in the sector given the headlines we're seeing, could you maybe just talk to how you think that could potentially impact given that manufacturing is in in the UK?

然後第二個問題實際上是關於關稅的，從我們看到的頭條新聞來看，這顯然已經成為該行業投資者關注的焦點，您能否談談，考慮到製造業在英國，您認為這可能會產生什麼影響？

Yeah, thanks a lot for joining. So, the question, the first question is related to, the ramp up of the centres getting online. I think we've seen in the first 30 centres, I think a pretty steady, sort of trajectory of these centres actually getting online, which I think has been, expected because we do have a, we didn't have the 30 centres prepared for onboarding by the time of approval and then it's the activation step that they were running through and you could see that basically that we had early January as we had reported around 20 centres that were active and then that obviously built then through the quarter to, now middle of March to about 33.

是的，非常感謝您的加入。所以，第一個問題與中心上線速度的提升有關。我認為我們已經看到前 30 個中心的上線軌跡相當穩定，我認為這是預期的，因為我們確實有一個，在批准時我們並沒有為這 30 個中心做好入職準備，然後是他們正在進行的激活步驟，你可以看到，基本上我們在 1 月初報告了大約 20 個活躍的中心，然後顯然在整個季度中都在增加到現在 3 月。

So there's a pretty continuous kind of flow and movement that we've seen with the next 30 centres, I think we, we'll see that, I think build gradually as we go through the year. It's obviously very much, a lot of that is really driven by the individual centres and the time, and the speed at which the onboarding process is sort of conducted. A lot of that has to do with legal reviews and so on.

因此，我們在接下來的 30 個中心中看到了一種相當連續的流動和運動，我想我們會看到這一點，我認為我們會隨著時間的推移逐漸建立起來。顯然，這很大程度取決於各個中心、時間以及入職流程的進行速度。其中很多與法律審查等有關。

And frankly the capacity at the respective hospitals to sort of manage that workload. So there is an element of variability, but we would assume that we have sort of a reasonably steady process as we go through the year, and we obviously, we'll be able to keep updating you on a quarter by quarter basis and also the actual centres obviously are visible for physicians and patients on the website. So it is something that actually is, can actually be followed and, but as, in terms of projection, we would expect that to go relatively steady as we go through the course of the year.

坦白說，各個醫院都有能力管理這些工作量。因此存在一些變化因素，但我們認為，在全年中，我們有一個相當穩定的過程，而且我們顯然能夠按季度向您更新，而且醫生和患者顯然可以在網站上看到實際的中心。因此，這實際上是可以追蹤的，但就預測而言，我們預計，隨著時間推移，這一趨勢將相對穩定。

With regards to tariffs, I think, very much an open question at this point in time whether there will be tariffs, what it might be, what type of products might be impacted, etc. I think very hard to speculate, in most other, I think in the past, if we look at tariffs that sort of imposed on pharmaceutical products. They tend to actually, be very, well thought through and typically minimal, because nobody wants to actually have an impact on the supply of medication for a population that's not a good thing to do from a health perspective, but also overall perspective, clearly not the, I think something that is really attractive, to impose.

關於關稅，我認為，目前仍是一個懸而未決的問題：是否會徵收關稅，徵收什麼關稅，哪些類型的產品會受到影響，等等。我認為，如果我們看看過去對藥品徵收的關稅，就很難推測大多數其他情況。它們實際上往往是經過深思熟慮的，並且通常影響很小，因為沒有人希望對人口的藥物供應產生實際影響，從健康角度來看這不是一件好事，而且從總體角度來看，這顯然不是一件有吸引力的事情。

And typically blocked products have been excluded from tariffs if you look at, historically at the development of tariffs. I think at this point; I think way too early to actually have a have a real view. I don't think we have visibility in the space and so at this point in time I don't think there's more that we can really comment on that.

如果你回顧關稅的歷史發展，那麼通常被封鎖的產品就被排除在關稅之外。我認為在這一點上；我認為現在還無法得出真正的觀點。我認為我們對這個領域還沒有清晰的認識，所以目前我們無法對此發表更多評論。

Thank you

謝謝

Asthika Goonewardene, Truist.

Asthika Goonewardene，Truist。

Hey, good morning and good afternoon guys. Thanks for taking my questions.

嘿，大家早上好，下午好。感謝您回答我的問題。

Among the centres that have treated patients in the commercial setting with their CAR T-cell, can you give us a little bit of color on what the spread is from, the spread of time from site activation to getting that first patient in and then have a quick follow up.

在商業環境中使用 CAR T 細胞治療患者的中心中，您能否向我們稍微介紹一下擴散的情況，從部位激活到接收第一位患者的時間跨度，然後進行快速跟進。

Yeah, so, thanks for joining, Asthika. It's quite variable, in terms of the time it takes to actually go from activation to actually having a patient on. For many of the centres, the, a lot of the activation process and the speed at which the activation process kind of went through has to do with the patient actually, being suitable for the therapy and considered to be suitable for the therapy and the momentum around that.

是的，感謝 Asthika 的加入。從實際啟動到實際有患者就診所需的時間而言，變化很大。對於許多中心來說，激活過程以及激活過程進行的速度實際上與患者有關，患者是否適合該療法，是否被認為適合該療法以及圍繞該療法的動力。

So there's some centres where there's a relatively short period in between, but you could also have situations where if the process, took a certain amount of time that maybe the patient had to move on to other therapy and then there might be somewhat of a bit of a lag until the next patient might actually come along. I think the short answer is it's variable.

因此，有些中心的治療間隔時間相對較短，但也可能出現這樣的情況：如果治療過程需要一定的時間，患者可能必須轉向其他療法，然後可能會有一點滯後，直到下一個患者真正到來。我認為簡短的回答是它是可變的。

I don't think it's, I don't think we could easily project that, within X amount of time the patients are on. We're seeing in general that we see, centres actually get into sort of a repeat mode, and actually get more than one patient, obviously on, which is really good because one of the things we would like to see that over time centres actually start using the product more regularly and with that, obviously you will start to see some element of momentum build over time. So early signs, I think, are very positive, but it's still early days.

我不認為我們可以輕易預測患者在 X 時間內的情況。總體而言，我們看到，各個中心實際上進入了一種重複模式，並且實際上接收了不止一名患者，這顯然非常好，因為我們希望看到的一件事是，隨著時間的推移，各個中心實際上開始更有規律地使用該產品，並且顯然，隨著時間的推移，您將開始看到一些勢頭的增強。所以我認為早期跡象非常積極，但現在還為時過早。

And then, I know it's very early age of the launch right now, but one of the intriguing things about our CAR T-cell was that, perhaps patients, do better by not having, but not, being bred to a transplant. And you've had several opportunities to talk about the data and present the data in medical journals, since approval. I'm just wondering with your initial experience right now.

然後，我知道現在推出該產品還處於早期階段，但我們的 CAR T 細胞的一個有趣之處在於，也許患者即使沒有接受移植，也不會因此而表現得更好。自從獲得批准以來，您已經多次有機會談論這些數據並在醫學期刊上展示這些數據。我只是想知道您現在的初步經驗。

What seems to be the sentiment among prescribers and treating physicians? Has there been some sort of an appreciation for this, or do you think you'll still need more time and to give them more hands-on experience to feel comfortable saying I don't want to take this patient to transplant after our CAR T-cell?

開處方者和主治醫生的情緒是怎麼樣的？對此是否有某種程度的讚賞，或者您是否認為您仍然需要更多時間並讓他們獲得更多實踐經驗，以便他們能夠放心地說我不想在 CAR T 細胞治療後帶這個病人去移植？

Yeah, I think that the question with regards to, is there a need for sort of subsequent therapy, when we look at the trial experience, we had about 18% of the patients move to a subsequent stem cell transplants, a relatively low percentage of the patients. A lot of the patients, if you had a prior transplant, actually wouldn't be eligible again for a transplant or they might have other, comorbidities, etc.that would sort of prevent, a transplant or make it unlikely to be successful.

是的，我認為問題是，是否需要進行後續治療，當我們回顧試驗經驗時，我們發現大約有 18％ 的患者進行了後續幹細胞移植，這一比例相對較低。許多患者如果之前接受過移植，實際上將不再適合再次接受移植，或者他們可能患有其他合併症等，這些都會阻礙移植或使移植不太可能成功。

So it depends to some extent on the nature of the patients coming in, but overall, obviously, even in the trial, we have seen a relatively limited use of transplant. We'll need to see kind of how that develops. I don't think at this point we have; we can even tell because it's just too early. But we also based on the experiences that the physicians had, with the product through the development that we would see probably initially a similar picture and then as there's more, I think experience gained we need to see where that, where that's headed.

因此，這在某種程度上取決於入院患者的性質，但總體而言，顯然，即使在試驗中，我們也看到移植的使用相對有限。我們需要觀察事情如何發展。我認為目前我們還沒有；我們甚至無法判斷，因為現在還為時過早。但是，我們也根據醫生對產品在開發過程中的經驗，最初我們可能會看到類似的情況，然後隨著經驗的積累，我們需要了解它的發展方向。

But overall, obviously very encouraging and also an option for, patients that currently, you would have, very limited treatment options for. And I think gives us an opportunity here to really position the product across the entire range of, risk factors of age, and I think that's really where, there's a significant appeal for this product because this, it is actually can actually, deliver positive outcomes across the entire range of the patients, that we have in the relapsed refractory setting.

但總體而言，這顯然非常令人鼓舞，而且對於目前治療選擇非常有限的患者來說也是一種選擇。我認為這給了我們一個機會，讓我們能夠真正將產品定位於所有年齡風險因素，我認為這就是該產品的巨大吸引力所在，因為它實際上可以為復發難治性環境中的所有患者帶來積極的結果。

And obviously, what we have seen is that the patients that were receiving transplant didn't appear to actually do better, and, than patients who did not receive transplant, and that certainly has resonated with a lot of the physicians. And so, we'll see how it how it develops. I think too early to tell, but overall I think a lot of conviction that there is a real opportunity for the product to be a standalone therapy without the need for subsequent consolidation.

顯然，我們看到接受移植的患者實際上並沒有比未接受移植的患者表現得更好，這肯定引起了許多醫生的共鳴。所以，我們將看看它如何發展。我認為現在下結論還為時過早，但總的來說，我相信該產品確實有機會成為一種獨立的治療方法，而無需後續的整合。

Matthew Phipps, William Blair.

馬修菲普斯、威廉布萊爾。

Hi Christian, thanks for taking my question. I was wondering if you could just maybe comment on any of the manufacturing success rate or turnaround time so far in the commercial launch, maybe just if it's, I guess maybe I'm in line with some of the clinical experience.

你好，克里斯蒂安，謝謝你回答我的問題。我想知道您是否可以評論一下迄今為止商業發布的製造成功率或週轉時間，也許只是，我想也許我與一些臨床經驗一致。

And then I assume that BioNTech has not yet made any decision on AUTO6NG in as far as opting in. Is there a timeline for when that might occur?

然後我假設 BioNTech 尚未就 AUTO6NG 的選擇做出任何決定。有沒有一個時間表顯示何時會發生這種情況？

Yeah, thanks for joining, Matt. In terms of sort of the production experience that we're gaining now on the commercial side, we see that actually mirroring very nicely what the experience was, during the conduct of the pivotal study. So that's very reassuring.

是的，謝謝你的加入，馬特。就我們現在在商業方面獲得的生產經驗而言，我們發現這實際上很好地反映了在進行關鍵研究期間的經驗。所以這讓人非常放心。

And obviously, we're starting to get more and more experience as we're sort of running more and more products through the facility, but we're seeing, the data to track very nicely what our prior experience was. So that's the first observation. The second question was related to the options that BioNTech has an option on our [solitu program 0.6NG], and that's an option that actually is still running, and I think it's obviously going to be an option as we had indicated before that will be triggered prior to moving the product into a pivotal study.

顯然，隨著我們透過工廠運作越來越多的產品，我們開始獲得越來越多的經驗，但我們看到，數據可以很好地追蹤我們之前的經驗。這是第一個觀察。第二個問題與 BioNTech 在我們的 [solitu 程式 0.6NG] 上提供的選項有關，該選項實際上仍在運行，而且我認為這顯然是一個選項，正如我們之前指出的那樣，它將在將產品轉移到關鍵研究之前觸發。

So we're still obviously running through the current clinical study we're conducting with UCL. And so, we would expect that trial to actually, deliver results and then after we have the results in that the path is clear for, the path forward is clear, that that sort of actually would sort of be the time point for an option exercise. So, it's still a little bit ahead of us here.

因此，我們顯然仍在與倫敦大學學院合作進行目前的臨床研究。因此，我們期望試驗能夠真正取得成果，然後在我們得到結果之後，路徑清晰，前進的道路清晰，這實際上將成為選擇權行使的時間點。所以，我們在這方面還有一點進步。

Gil Blum, Needham & Company.

吉爾·布魯姆（Gil Blum），Needham & Company。

Good afternoon. Good morning, and thanks for taking our question. Just a quick couple from us. So, we're going to see some of the SLE data and your upcoming R&D day and maybe you maybe you can put that data in context. I mean six patients, what kind of data are we're going to see here safety B-cell aplasia?

午安.早安，感謝您回答我們的問題。我們只是一對情侶。因此，我們將看到一些 SLE 數據和您即將到來的研發日，也許您可以將這些數據放在上下文中。我的意思是六名患者，我們將在這裡看到什麼樣的安全 B 細胞發育不全數據？

And my second question is where would you say most of your resources as it relates to the launch are being invested just site roll out or is there more to it?

我的第二個問題是，您認為與發布相關的大部分資源都投入到了哪裡，只是網站建設，還是還有其他用途？

Yeah, thanks a lot, much appreciated, Gil. So, with regards to the SLE data as I indicated, this is a cohort of six patients dosed of 50 million cells.

是的，非常感謝，吉爾。因此，就我指出的 SLE 數據而言，這是一組六名患者，接受了 5000 萬個細胞的治療。

There's a set of parameters we're looking at. The first set of parameters are really understanding the properties of the product. We've seen quite a bit of variability across the various programs in terms of the ability of the products to actually expand in vivo and the. So the persistence that there was observed with these products.

我們正在查看一組參數。第一組參數真正了解產品的屬性。就產品在體內實際擴增的能力而言，我們發現不同項目之間有相當大的差異。因此我們觀察到這些產品具有持久性。

So that's the first observation because that gives us a sense of the quality of the product and how it actually performs, and it also gives us an ability to sort of look at the, and compare back to as an example, the experience that the, [A Jets team] had in airline which I think is still kind of the key data point or set of data points that I think the field is comparing to.

這是第一個觀察結果，因為它讓我們了解產品的品質和它的實際性能，也讓我們能夠觀察並比較，例如，[Jets 團隊] 在航空公司的經驗，我認為這仍然是該領域正在比較的關鍵數據點或數據點集。

So first is product property from a behavior perspective of the product itself. The second is clearly around safety. We've seen variability in terms of the safety events. So, we're going to look obviously at the, CRS. We're going to look whether there's anything that we would pick up on neurological talks, but that gives us sort of the next picture element of the picture in terms of the behavior of the product in these autoimmune patients.

首先是從產品本身的行為角度來看的產品屬性。第二個顯然是關於安全。我們已經看到安全事件方面的變化。因此，我們顯然會關注 CRS。我們將看看是否有任何我們可以在神經學談話中發現的東西，但這為我們提供了關於產品在這些自身免疫患者中的行為的下一個圖像元素。

The third area is around the actual expected action of the product, and that actually goes to the depletion of B-cells. So, we're going to look at B-cell depletion. We're also going to look at the impact on auto reactive antibodies. We're going to look at disease scores, and in particular we're going to also look at not just the disease score as a generic score, but also to look at the individual components of the disease score, which I think is important and has certainly led to a bit of confusion during the last year when I think, different data sets were compared to each other or people were trying to do that.

第三個領域是圍繞產品的實際預期作用，這實際上與 B 細胞的消耗有關。因此，我們將研究 B 細胞耗竭。我們也將研究對自身反應抗體的影響。我們將研究疾病評分，特別是我們不僅要將疾病評分作為一般評分來研究，還要研究疾病評分的各個組成部分，我認為這很重要，並且在去年當不同的數據集相互比較或人們試圖這樣做時肯定會引起一些混亂。

In general, I think the patient population we're looking at, is a sort of a more advanced and more real world population that we're looking at, in our CARLYSLE study. These are patients that do have, actually significant impact on the kidney, and so it is a population that has, a, an actual level of, tissue damage that you actually do see an impact on kidney function.

總的來說，我認為我們在 CARLYSLE 研究中關注的患者群體是一種更先進、更真實的群體。這些患者的腎臟確實受到了嚴重的影響，因此，他們是具有一定程度組織損傷的人群，而腎臟功能確實受到了影響。

So it's a more real world population compared to the very young and early in the disease population that we've seen in airline, but I think it gives us a very good view to sort of actually compare to some of those early experiences, but also gives us an understanding of the profile of the product. The follow up obviously is limited, and that's also what we're pointing to the second half of the year for longer term follow up, full reconstitution of the of the B-cell compartment post persistence, stops in those patients.

因此，與我們在航空公司看到的非常年輕和早期患病人群相比，這是一個更真實的世界人群，但我認為這讓我們能夠很好地與一些早期經驗進行比較，同時也讓我們了解產品的概況。顯然，後續行動是有限的，這也是我們指向下半年進行長期跟進的原因，在這些患者中，B 細胞區室在持續存在後會完全重建，並停止。

So that will be sort of a second data set later in the year, but I think we're going to get a very good feel for the product and the properties that we were expected, that we expect to see in these patients.

所以這將是今年稍後的第二組數據集，但我認為我們將對該產品以及我們預期在這些患者身上看到的特性有非常好的了解。

And then in terms of so the resources going into the launch, I think what's important about from a commercial perspective that, what we're delivering at this with these types of therapies is really a set of services, to support the centres. So it's different from your conventional, commercial model, and it's much more focused on delivering services and providing support.

然後就投入到發布的資源而言，我認為從商業角度來看重要的是，我們透過這些類型的療法提供的實際上是一套支持中心的服務。因此，它不同於傳統的商業模式，它更注重提供服務和支援。

We do that through, a single point of access that actually, triages and supports the centre, triages the needs and requests for support, and actually it's directly engaging with the centres, and partners with the centre very closely. I think that's sort of the model that we're running and that's obviously been supported by medical affairs, as well as obviously the support on the reimbursement side.

我們透過單一存取點來實現這一點，該存取點實際上對中心進行分類和支持，對支援需求和請求進行分類，並且實際上直接與中心接觸，並與中心密切合作。我認為這就是我們正在運行的模型，並且顯然得到了醫療事務的支持，以及報銷方面的支持。

And the engagement from a market access perspective. So that's sort of the distribution we have. So, it's much more on the service side than it would be sort of the more classical, sales and marketing functions that you would have with a conventional, launch of a product. So maybe that could be helpful.

以及從市場進入角度的參與。這就是我們的分佈情況。因此，它更多的是在服務方面，而不是傳統的產品發布中的銷售和行銷功能。所以這也許會有幫助。

Kelly Shi, Jefferies.

Kelly Shi，傑富瑞集團。

Congrats on the progress and thank you for taking my questions.

恭喜您的進展，感謝您回答我的問題。

I have to first, for the adult ALL program curious if the first wave of treatment, adoption included the centres had no prior [triages] experience and, for the centres have some hesitation to make a switch from triages to what would be the top reasons you're here?

首先，對於成人 ALL 計劃，我很好奇第一波治療、採用是否包括中心之前沒有 [分診] 經驗，並且對於中心是否猶豫從分診轉換為其他治療，您來這裡的主要原因是什麼？

Yeah, thanks for the questions, Kelly. I think what's been very interesting to see is that we had both centres with prior experience with obe-cel as part of the FELIX study, as well as centres that were not part of the FELIX study that we saw actually very early on, onboarding and activate and getting activated. So it's very interesting to see that we have, both types of centres actually moving very quickly.

是的，謝謝你的提問，凱利。我認為非常有趣的是，我們既有在 FELIX 研究中與 obe-cel 有過合作的中心，也有在 FELIX 研究初期就未參與其中的中心，這些中心也參與了入職、激活和激活。因此，看到這兩種類型的中心實際上都發展得非常快，這非常有趣。

And we do see that there's clearly a substantial need there in terms of patients that were considered by those physicians to be very suitable for the treatment with obe-cel and in their view, apparently felt that that was the appropriate treatment for these patients. So it was very interesting to see the dynamic of both types of centres to get on very quickly.

我們確實看到，這些醫生認為患者非常適合使用 obe-cel 治療，並且顯然認為這是適合這些患者的治療方法，因此，這些患者顯然有很大的需求。因此，看到這兩種類型的中心的動態快速發展是非常有趣的。

And I think we're seeing, very good, sort of interest levels for using the product, early on and across quite a wide range of patients in terms of the conditions that the patients were in. So I think overall, I think, looking very positive and sort of, similar to kind of the range of experience I think that we were having in the pivotal study.

我認為，我們在早期就看到了對使用該產品的興趣水平很高，而且從患者所處的狀況來看，患者群體非常廣泛。所以我認為總體而言，看起來非常積極，並且有點類似於我們在關鍵研究中累積的一系列經驗。

Thanks for the color and also for SLE you have mentioned that you could add a few more patients at the same 50 million dose or higher. Just curious, what kind of efficacy signals would drive your decision to do higher than $50 million or alternative question here is, after several, data sets dropped from last year for [cell] therapy and SLE, could you share your insights on the treatment the goal of CAR-T for lupus at this moment?

感謝您提供的信息，對於 SLE，您還提到，您可以在相同的 5000 萬劑量或更高劑量下增加更多患者。只是好奇，什麼樣的療效訊號會促使您決定投入超過 5000 萬美元，或者另一個問題是，在去年 [細胞] 療法和 SLE 的幾組數據集被​​刪除之後，您能否分享您對目前 CAR-T 治療狼瘡目標的見解？

Yeah, so, obviously the way we set up the study is to, go in with a fixed dose, which is a translation of the pediatric ALL dose, use that as the basis for the fixed dose. That's how we arrived at the 50 million cell dose. We then had an opportunity or designed the trial in a way that would allow us to actually step up or step down. And, we also have an opportunity to expand the cohort. We'll provide more information obviously at the R&D day and we'll sort of give you a sense of kind of how we're moving forward and what the next steps are and where we're going to go, in that space.

是的，所以，顯然我們進行研究的方式是採用固定劑量，這是兒科 ALL 劑量的翻譯，並以此作為固定劑量的基礎。這就是我們得出 5000 萬個細胞劑量的方法。然後我們就有機會或設計試驗，以便我們能夠真正地加強或減弱。而且，我們也有機會擴大群體。我們顯然會在研發日提供更多信息，讓您了解我們未來的進展、下一步計劃以及我們在該領域的發展方向。

And I think that will sort of answer actually I think the question in much more deeply. Fundamentally, we're obviously, I think we're at a good place. In terms of, the experience that we had and also the safety data we already had, with the product at that dose level as well as the efficacy level and it's the ability to really remove B-cells very deeply, in patients based on the pediatric ALL as well as the adult ALL experience.

我認為這實際上可以更深入地回答這個問題。從根本上來說，我認為我們顯然處於一個很好的位置。就我們已有的經驗以及現有的安全數據而言，該產品在劑量水平和功效水平上具有非常深層清除 B 細胞的能力，這是基於兒童 ALL 和成人 ALL 的經驗。

So we think we're in a good spot there. We have a good understanding of what our product does and how it behaves. And we're looking forward to giving you the update in terms of where we're going to go next, at the, April 23rd R&D day.

因此我們認為我們目前處於有利地位。我們對我們的產品的功能和行為有很好的了解。我們期待在 4 月 23 日的研發日向您通報我們下一步的計畫。

And then I think you had a question related to SLE and the positioning of [CAR T-cell]. Did I hear that right?

然後我認為你有一個與 SLE 和定位相關的問題[CAR-T細胞]。我沒聽錯吧？

Yes, okay

是的，好的

So I think with our review actually in terms of the positioning of CAR T-cell, I don't think has really changed. Obviously when you look at SLE in the US, you've got about 400,000 patients overall, so it's a very large population on an incidence basis, but many of these patients can be managed, with standard of care at the at a reasonably sensible level.

因此我認為，實際上從我們對 CAR T 細胞定位的審查來看，我認為並沒有真正改變。顯然，當你觀察美國的 SLE 時，你會發現總共有大約 40 萬名患者，因此從發病率來看，這是一個非常龐大的群體，但其中許多患者都可以透過合理水平的標準護理進行管理。

But you do have a small proportion of patients that do actually progress, to very severe stages of the disease, where the level of intensity of therapy that we're obviously having with the CAR-T therapy, we believe is very well positioned, very well warranted. And that's actually a much smaller population. We had indicated that this is somewhere between 10,000 and 20,000 patients out of the 400,000.

但確實有一小部分患者的病情確實進展到了非常嚴重的階段，我們認為，我們採用 CAR-T 療法所達到的治療強度水平非常合適，非常有必要。但實際上，這個數字要小得多。我們曾指出，在 40 萬名患者中，約有 1 萬至 2 萬名患者。

So it's a much smaller population in the true high medical needs segment of the disease where we think that this type of a therapy is well suited to be used, and I think also where you have a compelling health economic argument, to treat those patients with a therapy.

因此，我們認為，在真正具有高醫療需求的疾病群體中，只有一小部分人適合採用這種療法，而且我認為，在有令人信服的健康經濟論點的情況下，可以用這種療法治療這些患者。

Yanan Zhu, Wells Fargo.

朱亞南，富國銀行。

Great. Thanks for taking our questions.

偉大的。感謝您回答我們的問題。

So first, I was wondering, could you comment on in terms of the centres onboarded, have you onboarded the Top 10 centres in terms of, BALL patient volume or is there still work to be done there?

所以首先，我想知道，您能否評論一下已入駐的中心情況，就 BALL 患者數量而言，您是否已入駐前 10 名的中心，或者那裡是否還有工作要做？

And, also wondering, are you in a position to comment on a number of apheresis, to date, or how has that been evolving? And lastly, AUCATZYL was wondering if you, whether you plan to provide sales guidance at some point, and if so, when might be the right time to do so?

另外，我還想知道，您是否可以評論一下迄今為止的血液分離術的數量，或者其發展情況如何？最後，AUCATZYL 想知道您是否計劃在某個時候提供銷售指導，如果是，什麼時候是合適的時機？

Thanks a lot, and I do understand your questions, so let me go through first of all, have the top 10 centres being included, when you go on to the, this website, you can actually see the centres that are on there. You do see that, many of the top institutions in the US are already in a position to actively, deliver or cancel. So, I think that's something, that's actually publicly visible. You see the key centres there, that have very significant catchment area and very consistent, high levels of patient flows.

非常感謝，我確實理解您的問題，所以首先讓我來介紹一下，其中包括排名前 10 位的中心，當您訪問這個網站時，您實際上可以看到那裡的中心。你確實看到，美國許多頂尖機構已經做好了積極實施或取消的準備。所以，我認為這是實際上公開可見的事情。您可以看到那裡的關鍵中心，它們擁有非常大的集水區和非常穩定、高水準的患者流量。

So, we do believe that within those, first 33 centres that we have, many, of the very high volume centres, there are probably only a few additional high volume centres that may not yet be active at this point.

因此，我們確實相信，在我們擁有的首批 33 個中心中，許多都是業務量非常大的中心，可能只有少數幾個額外的業務量大的中心目前可能尚未活躍。

And this is why we're guiding to, already within that population to cover a very substantial proportion of the, of, provided, a large proportion of access to the US patients already. And that also coincides when you look at the distribution also with the big, the areas in the states with a lot of, with high levels of population, across as well, which is a way to look at this and sort of get a feel for that.

這就是為什麼我們要引導已經在該人群中覆蓋很大一部分人，已經為美國患者提供了很大一部分治療機會。而且，當您查看分佈情況時，也會發現情況與各州中人口眾多、人口密集的地區的分佈情況相吻合，這是一種觀察和感受這種情況的方式。

With regards to apheresis, we do not guide on apheresis. And I think there's been some companies that have tried to do that. We don't think it's going to be helpful to do that because there's obviously a time difference between aphes collection and actually dosing of the patients which actually then gets, I think, a very complex way of reporting and sort of following the story.

關於血液分離術，我們不提供血液分離術指導。我認為有些公司已經嘗試這樣做了。我們認為這樣做不會有幫助，因為在收集血小板和實際給患者服藥之間顯然存在時間差，我認為這實際上需要一種非常複雜的報告和追蹤方式。

So we're going to report actually on the patients that were dosed. Which we think is the cleanest way of doing that because that is also the time point when in fact you re you recognize revenue. So that's important. So, we're going to have a very consistent way of reporting that and we're not going to give a leading-edge sort of view based on the number of states.

因此，我們將實際報告接受治療的患者情況。我們認為這是最乾淨的方式，因為這也是您實際確認收入的時間點。這很重要。因此，我們將採用非常一致的方式來報道這一點，並且我們不會根據州的數量給出前沿的觀點。

And then the last point was around sales guidance. We certainly for this year we will not give any, sales guidance, and we don't believe that that's actually a very sensible thing for us to do, to give guidance, simply because you basically have multiple.

最後一點是關於銷售指導。我們今年當然不會給出任何銷售指導，而且我們認為，僅僅因為基本上有多個銷售指導，我們實際上並不認為這是非常明智的做法。

Developments that you're actually going to go through that each one of them will be on a trajectory and a and a curve of its own. So, you have obviously the number of centres that are active and you'll see that report on that and this is publicly visible. So that is also the basis to even have an ability to deliver therapy. So that momentum and the onboarding and the addition of centres obviously will sort of increase your footprint and your ability to sort of, drive sales.

您實際上將要經歷的發展，每個發展都會有自己的軌跡和曲線。因此，您顯然知道活躍的中心數量，並且會看到有關該中心的報告，而這些報告都是公開可見的。所以這也是提供治療能力的基礎。因此，這種勢頭、入職培訓和中心的增加顯然會增加您的足跡和推動銷售的能力。

The second aspect is that obviously within each one of the centres, there are multiple physicians that typically do deliver therapies. They have different backgrounds, and you often start with an individual physician starting to use the product and over time and experience gain more of the physicians, we expect to start using the product. That's another kind of ramp that you're going through. And the third has a lot to do with obviously the experience made with the program per se.

第二個方面是，顯然在每個中心內，都有多位醫生通常會提供治療。他們有不同的背景，通常從個別醫生開始使用產品開始，隨著時間的推移和經驗的積累，我們希望更多的醫生也開始使用該產品。這是您要經歷的另一個坡道。第三個顯然與程式本身的經驗有很大關係。

And with that, the ability to actually, get access, and provide access to a larger proportion of patients who today may not actually have, considered access to as well. So, you have several, developments that each of those are in an in curve. Trying to actually overlay that and project is actually very challenging, and we're not planning to do that. So, we're going to actually stick with reality, which is patience dost and revenue recognizable. And I think that gives us a very clear, very clean communication. I think we'll allow everybody to follow exactly where we are.

這樣，我們實際上就能夠獲得治療機會，並為今天可能實際上沒有考慮過治療機會的更多患者提供治療機會。因此，您有幾種發展趨勢，每種趨勢都呈現曲線狀。嘗試真正覆蓋該和項目實際上是非常具有挑戰性的，我們不打算這樣做。因此，我們實際上將堅持現實，即耐心和可確認的收入。我認為這給我們帶來了非常清晰、非常乾淨的溝通。我想我們會讓每個人都準確地跟隨我們的步伐。

Great. That makes a lot of sense. If I may have a very quick, follow up on the SLE second half data update. I was wondering, beyond the additional follow-up for the first six patients, what might be the incremental, date, new data, at that update?

偉大的。這很有道理。如果可以的話，我可以很快跟進 SLE 下半年的資料更新。我想知道，除了前六名患者的額外跟進之外，更新後的增量、日期和新數據可能是什麼？

Yeah, so I think the most important update will be obviously the follow up because one of the key questions that you have with this type of a therapy is whether indeed you had a full reset of the compartment. So, whether you were able to actually, have an impact on the disease, remove the auto reactive antibodies. And then actually once the therapy stops working in the patient, you see the recurrence of the B-cells and what you want to see at that point is an absence of all the reactive B-cells that gives you the information that indeed you were able to do a reset in the compartment.

是的，所以我認為最重要的更新顯然是後續行動，因為對於這種類型的治療，其中一個關鍵問題是您是否確實對隔間進行了完全重置。因此，無論您是否能夠真正對疾病產生影響，請去除自體反應抗體。實際上，一旦治療對患者不再起作用，你就會看到 B 細胞的複發，而此時你想要看到的是所有反應性 B 細胞的消失，這為你提供了信息，表明你確實能夠在隔室中進行重置。

So I think that's really important information because it gives you information about the actual clinical impact and true impact that the therapy will have. So that's the most important information and then we're going to guide obviously at the April meeting and how we're going to plan going forward, but I think the primary and the most valuable piece of the information we'll be sharing will certainly be around the long-term follow-up.

所以我認為這是非常重要的訊息，因為它提供了有關治療的實際臨床影響和真實影響的資訊。這是最重要的訊息，然後我們顯然會在四月份的會議上提供指導，並說明我們將如何規劃未來，但我認為我們將要分享的主要和最有價值的信息肯定是圍繞長期後續行動。

Great, thank you.

太好了，謝謝。

Jacob Mekhael, KBC Securities.

Jacob Mekhael，KBC 證券。

Hi there, and thanks for taking my question. I just wanted to zoom in again on the initial experience with AUCATZYL in the commercial setting, particularly in terms of the vein-to-vein time that you have been able to achieve. Have you been able to achieve your target of 16 days with the first few batches and perhaps more broadly, what has been going well and are there any learnings from the first few?

您好，感謝您回答我的問題。我只是想再次放大在商業環境中使用 AUCATZYL 的初步體驗，特別是您能夠實現的靜脈到靜脈時間方面。您是否能夠透過前幾批實現 16 天的目標？更廣泛地說，哪些方面進展順利？從前幾批您學到了什麼？

Yeah. I guess batches that you will implement going forward.

是的。我猜你們將陸續實施這些批次。

Yeah, so, thanks for joining Jacob. So what we see actually In the during the initial phase of the launch in terms of the turnaround time for the product is that we see a high degree of consistency with our prior experience and tracking on within our expectations that we had for and the guidance that we had out for the product itself. So we feel very confident that the consistency we're seeing actually builds very nicely and we see those processes work very well.

是的，感謝 Jacob 的加入。因此，就產品發布初期的周轉時間而言，我們實際上看到的是，它與我們先前的經驗高度一致，並且符合我們對產品本身的預期和指導。因此，我們非常有信心，我們看到的一致性實際上建立得非常好，我們看到這些流程運作得非常好。

In terms of the learnings, I think one of the interesting things, of course, is that I've mentioned that in the context of the manufacturing side it's little the patient number one coming through the door, basically that's when you actually, turned the engine on and you start to actually have every aspect of the process. From, supporting the centres to with information to support actually and secure reimbursement all the way through to the actual handling of the product, the handling of the reset, the whole logistics chain, the manufacturing process itself, and then obviously the additional support of the centre in terms of training, etc.

就學習而言，我認為其中一件有趣的事情當然是，我提到過，在製造方面，它就像是第一個走進門的病人，基本上就是當你真正打開引擎，開始真正掌握流程的各個方面的時候。從為中心提供資訊支援、實際支援和確保報銷，一直到產品的實際處理、重置處理、整個物流鏈、製造過程本身，當然還有中心在培訓等方面的額外支援。

So you have actually all of those items that actually start to actually run and also they have to run on time. They have to be consistent, and all of the systems also have to be robust and stable. And that's an interesting transition. So, I think a lot of, good input that we had working very closely with the centres to really focus on making sure that the experience for the centres are positive and that we're also taking as much of the workload of the centres and I think that's been a key focus and.

因此，實際上所有這些項目都開始實際運行，而且它們必須按時運行。它們必須保持一致，並且所有系統也必須強大且穩定。這是一個有趣的轉變。因此，我認為，我們與各中心密切合作，獲得了很多很好的意見，真正致力於確保各中心的體驗是積極的，並且我們也承擔了盡可能多的中心工作量，我認為這一直是一個重點。

As you can imagine, each centre works a bit differently and so there's a lot of, learnings that obviously we're going through with each one of the centre just to make sure that this is a positive an experience as possible and that we're continuously improving our platform, for the engagement, the booking, and all the way through in terms of the delivery of the product.

你可以想像，每個中心的工作方式都有點不同，所以我們顯然要與每個中心一起學習很多東西，只是為了確保這是一個盡可能積極的體驗，並且我們正在不斷改進我們的平台，以提升參與度、預訂能力，並在整個產品交付過程中不斷改進。

So this is an ongoing process and I think we're seeing, really good collaboration, with all our centres, very valuable feedback, and we're continuously looking and strive to actually improve the experience and that's actually the process we're in and we're convinced we're going to be in that for the duration of the delivery of this product because we want to be as easy to use as possible for the centres, as easy to access as possible.

所以這是一個持續的過程，我認為我們看到了與所有中心的良好合作，得到了非常寶貴的反饋，我們也在不斷尋求並努力改善體驗，這實際上就是我們正在進行的過程，我們確信我們將在產品交付期間一直保持這種狀態，因為我們希望中心盡可能方便使用，盡可能方便訪問。

And we're going to continue to work on that to make sure that that's going to be an experience that we can actually continuously improve over time. But great start, good level of engagement, great feedback, and I think, puts us in a very strong position.

我們將繼續努力，以確保這將是一個能夠隨著時間的推移而不斷改進的體驗。但良好的開端、良好的參與度、良好的回饋，我認為，讓我們處於非常有利的地位。

Okay, thank you. I just have one more, if I may, on your conversations with the EMA on the EU approval. Based on those conversations, where in the second half do you expect the approval to come?

好的，謝謝。如果可以的話，我還有一個關於您與 EMA 就歐盟批准進行的對話的問題。根據這些對話，您預計下半年會何時獲得批准？

And perhaps, are you able to comment on any preparations that you're working on for the EU launch? And how does that process compare to the US in terms of centre on boarding?

或許，您能評論一下您為歐盟啟動所做的準備工作嗎？就登機中心而言，這項流程與美國相比如何？

Yeah, so the, interaction with the European agency is going through the normal process, which is a very well described, and also from a timeline perspective, etc. well-defined process, to go through, so that's we're on, that's running. We started the process in, the end of March last year, so we're kind of getting to the latter later part of the process, which is a series of questions, answers, additional review, final questions, again, a review answers, a final review, and then you go into the final steps, that sort of ultimately result in an approval or no approval.

是的，與歐洲機構的互動正在按照正常流程進行，這個流程描述得非常清楚，而且從時間表等角度來看，也是一個定義明確的流程，所以這就是我們正在進行的。我們從去年三月底就開始了這個過程，所以我們現在進入了這個過程的後半部分，即一系列的問題、答案、額外的審查、最後的問題，再次，審查答案，最後審查，然後進入最後的步驟，最終決定批准或不批准。

So we're in that, second half of the process, but I don't think it makes sense for us to actually try to pinpoint a date that, wouldn't be a sensible thing for the for us to do because frankly, we don't run the clock. So with regards to the preparation, I mean very similar to, what we did in the US in terms of preparation, working with the clinical centres, in the UK and we're working with, clinical centres.

因此，我們處於這個過程的後半段，但我認為我們實際上沒有必要嘗試確定一個日期，這對我們來說不是一件明智的事情，因為坦白說，我們不按時完成。因此，就準備工作而言，我的意思是，這與我們在美國與臨床中心合作所做的準備工作非常相似，在英國，我們也在與臨床中心合作。

An earlier stage in Germany as the first country that we're interested in to potentially be in a position to launch. So we're in conversation with the centre who start to do the preparatory work as we've done in the US, very similar process that we're running through, and a lot of the learnings that we have made in the US, obviously very applicable also for the UK as well as is applicable for European centres.

德國是我們感興趣的第一個可能開展這項業務的國家，目前處於早期階段。因此，我們正在與開始進行準備工作的中心進行對話，就像我們在美國所做的那樣，我們正在經歷非常相似的過程，而我們在美國學到的許多東西顯然也適用於英國以及歐洲的中心。

So that's ongoing, and obviously gives us a very strong basis because obviously a lot of the systems have been worked out. Already for the US launch and, they, require typically on the minimal adaptation, for, the jurisdictions in Europe as well. So, we think we're in a very good spot there and can do that and, actually, frankly do that work in a very efficient way.

所以這是持續進行的，並且顯然為我們提供了非常堅實的基礎，因為顯然很多系統已經制定出來了。它們已經在美國推出，通常也需要進行最低限度的調整，以適應歐洲的司法管轄區。因此，我們認為我們處於一個非常好的位置，可以做到這一點，而且實際上坦率地說，可以非常有效地完成這項工作。

Okay, thank you. That's very clear.

好的，謝謝。這非常清楚。

Simon Baker, Redburn Atlantic.

西蒙貝克 (Simon Baker)，雷德伯恩大西洋公司 (Redburn Atlantic)。

Thank you very much for taking my question too, if I may please. Firstly, just continuing on or cancel and the UK, typically we see the importance of a NICE, assessment as having relevance far beyond the borders of the UK. So I just wondering if you could give us an idea on the expected timeline of the decision, by NICE on or [CAR-T cell].

如果可以的話，也非常感謝您回答我的問題。首先，繼續或取消，在英國，我們通常認為 NICE 評估的重要性遠遠超出了英國的邊界。所以我只是想知道你是否可以告訴我們 NICE 預計做出決定的時間表，或者[CAR-T細胞]。

And then moving on to the CARLYSLE study, could you give us an idea of the duration of exposure that we will see at that interim analysis for the six patients you started dosing in February 24, so I just want you to give us some flavor of how much follow up there will be across those initial sic patients?

然後談到 CARLYSLE 研究，您能否告訴我們，在中期分析中，對於您於 2 月 24 日開始為 6 名患者進行的藥物治療，我們將看到患者接受藥物治療的持續時間，我只是想讓您告訴我們，對於這些最初患病的患者，將會進行多少次跟踪？

Thanks Simon. So, I'll start with the second question, which is sort of the follow-up time. Out of the six patients, we're going to have one patient with more than six months of follow up, two patients with more than three months, and three patients that are somewhere between one and three months of follow up.

謝謝西蒙。那麼，我將從第二個問題開始，這是一個後續時間。在六名患者中，我們將有一名患者的追蹤時間超過六個月，兩名患者的追蹤時間超過三個月，三名患者的追蹤時間在一到三個月之間。

So that's sort of the. The nature of the follow-up, and that's also why I indicated the importance of going to the second half of the year for longer follow up and understanding kind of the overall profile in terms of the reconstitution of the visa compartment.

就是這樣。後續行動的性質，這也是為什麼我指出下半年進行更長時間的跟進和了解簽證重組總體情況的重要性。

With regards to the, to the UK, as you point out, this sort of two processes that you run in the UK you have on the one hand, the regulatory process which is run through the MHRA and has its run through its own timeline.

關於英國，正如您所指出的，英國運作的這兩種流程一方面是透過 MHRA 運作的監管流程，有自己的時間表。

It's the second set of engagements which is really to sort of actually demonstrate the health economic benefit of your product as part of the as part of the assessment that ultimately will lead them to a determination of what the price in the UK is.

這是第二組活動，實際上是為了展示您的產品的健康經濟效益，作為評估的一部分，最終將幫助他們確定英國的價格。

Both processes take, not insignificant amount of time, and both are processes that are ongoing and, obviously not entirely under our control in terms of the timing. But I think it, both are, well on where they need to be, relative to each other, and so we're looking forward to updating you once we're sort of actually cleared the regulatory hurdle and then obviously we can talk about the final steps that you have to go through before you can actually deliver product in the UK.

這兩個過程都需要花費相當多的時間，而且都是持續進行的過程，顯然在時間方面我們並不完全能夠控制。但我認為，兩者都處於各自需要的位置，因此，一旦我們真正清除了監管障礙，我們期待著向您通報最新情況，然後我們顯然可以討論在您真正向英國交付產品之前必須經歷的最後步驟。

Great, thanks so much.

太好了，非常感謝。

And I would now like to hand the call back to Christian for closing remarks.

現在我想把發言權交還給克里斯蒂安，請他作最後發言。

Yeah, first off, thanks a lot for joining exciting 2024. I think we're in a really good start for 2025. We're excited about where we are with the launch, the opportunity to, broaden the utility, of obe-cel in the future as well.

是的，首先，非常感謝您參加令人興奮的 2024。我認為我們對於 2025 年已經有了一個非常好的開始。我們對 obe-cel 的發布感到非常興奮，我們也有機會在未來擴大其實用性。

And we're looking forward to updating you at the 23rd of April at the R&D Day in New York, and obviously we would love to see many of you actually be able to join us in person at that event. So, thank you very much and thanks for your questions. Have a great day.

我們期待在 4 月 23 日紐約研發日向你們通報最新情況，顯然，我們很高興看到你們中的許多人能夠親自參加這項活動。非常感謝您，也感謝您的提問。祝你有美好的一天。

And 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。