Autolus Therapeutics PLC (AUTL) 2025 Q3 法說會逐字稿

Good day. Thank you for standing by. Welcome to Autolus Therapeutics' third-quarter 2025 financial results conference call. (Operator Instructions) Please note that today's conference is being recorded.

再會。感謝您的耐心等待。歡迎參加 Autolus Therapeutics 2025 年第三季財務業績電話會議。（操作員說明）請注意，今天的會議正在錄音。

I will now hand the conference over to your first speaker, Amanda Cray, Executive Director for Investor Relations. Please go ahead.

現在我將把會議交給第一位發言人，投資者關係執行董事阿曼達·克雷。請繼續。

Thank you, Livia. 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. 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 1995.

謝謝你，莉維婭。各位早安/下午好，感謝各位參加今天的電話會議。與我同行的還有我們的執行長克里斯蒂安·伊廷博士；以及財務長羅布·多爾斯基。我想提醒各位，在今天的電話會議中，我們將就我們的業務發表一些根據聯邦證券法和 1995 年《私人證券訴訟改革法案》安全港條款屬於前瞻性的聲明。

These may include, but are not limited to, statements regarding status of the ongoing commercial launch of AUCATZYL in the US; Autolus's manufacturing, sales, and marketing plans for AUCATZYL; the market potential for AUCATZYL; and the status of clinical trials, development, and/or regulatory timelines and market opportunities for obe-cel and our other product candidates.

這些可能包括但不限於以下聲明：AUCATZYL 在美國持續商業上市的狀況；Autolus 公司針對 AUCATZYL 的生產、銷售和行銷計劃；AUCATZYL 的市場潛力；以及 obe-cel 和我們其他候選產品的臨床試驗、開發和/或監管時間表以及市場機會的狀況。

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 statements. 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.

這些聲明受多種風險和不確定因素的影響，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目前為止的觀點。我們不承擔更新任何此類前瞻性陳述的義務。有關可能影響我們實際業績的重大風險和不確定性的討論，請參閱今天發布的新聞稿和我們向美國證券交易委員會提交的文件中所列的風險，這兩份文件均可在我們網站的投資者關係部分查閱。

On slide 3, you'll see the agenda for today's call. As usual, Christian will provide an overview of our operational highlights. Rob will then discuss the financial results, and Christian will conclude with upcoming milestones and closing remarks. We'll then take questions. With that, I'll turn it over to Christian.

在第 3 張投影片上，您將看到今天電話會議的議程。克里斯蒂安將照例概述我們的營運亮點。接下來，羅布將討論財務業績，克里斯蒂安將總結即將到來的里程碑並作閉幕致辭。接下來我們將回答問題。接下來，我將把麥克風交給克里斯蒂安。

Thank you very much, Amanda, and let's move to slide number four. Welcome, everybody, and thank you for joining us at the third quarter financial results. We had a very good quarter, and I think we're off to an excellent launch with AUCATZYL in the US treating or targeting patients with relapsed/refractory BLL. We managed in the first nine months to achieve market leadership, broad market access and coverage, and established reliable product delivery.

非常感謝你，阿曼達，我們來看第四張投影片。歡迎各位，感謝各位參加第三季財務業績發表會。我們本季業績非常好，我認為 AUCATZYL 在美國的上市將會非常成功，該產品用於治療或針對復發/難治性 BLL 患者。在最初的九個月裡，我們成功實現了市場領先地位、廣泛的市場准入和覆蓋，並建立了可靠的產品交付系統。

We also believe that there is a significant opportunity to grow the CAR T market in this indication, and we're very pleased with the feedback we're receiving from physicians using the product and the interest expressed in conducting investigator-sponsored trials in front-line settings in ALL as well.

我們也相信，CAR T 市場在該適應症領域有很大的發展機會，我們對使用該產品的醫生給予的反饋以及他們對在 ALL 一線治療中開展研究者發起的試驗表現出的興趣感到非常高興。

We're now at the point where we have achieved a significant amount of stability in our operation and our ability to deliver product in a timely and high-quality manner. And we're now actually focusing on optimizing our operation and really leveraging the investments that we've made in our infrastructure and our systems and have now an opportunity with a lot of data that we collected along the way in these first nine months to optimize our processes, and with that, drive efficiencies going forward.

現在，我們的營運已經相當穩定，並且能夠及時、高品質地交付產品。我們現在正專注於優化運營，真正利用我們在基礎設施和系統方面的投資，並有機會利用我們在前九個月收集的大量數據來優化流程，從而提高未來的效率。

Importantly, in parallel, we're expanding the opportunity that we believe we have with obe-cel or AUCATZYL and are looking to build a pipeline in a product and are working on three current indications. The first one is in pediatric ALL, where we're initiating a potentially pivotal study, a Phase 2 study in lupus nephritis, also with an intent to drive towards a label, and an exploratory Phase 1 study in progressive multiple sclerosis. In short, we're focusing on driving market share in ALL, improve the margins, and expand beyond ALL.

重要的是，同時，我們正在擴大我們認為與 obe-cel 或 AUCATZYL 相關的機遇，並尋求建立產品線，目前正在研究三種適應症。第一項是針對兒童急性淋巴性白血病（ALL）的，我們正在啟動一項可能具有關鍵意義的研究；第二項是針對狼瘡性腎炎的 2 期研究，也旨在獲得適應症標籤；第三項是針對進行性多發性硬化症的探索性 1 期研究。簡而言之，我們的目標是提高 ALL 市場的份額，提高利潤率，並拓展到 ALL 以外的市場。

Moving to slide number 5, quick view on the performance that we have to date in our launch of AUCATZYL in the US. We have achieved $21.1 million in net sales in the third quarter, and we have deferred revenue of $7.6 million indicating that there is a good number of products currently sitting at the centers at the end of the third quarter, not yet infused and ready for infusion in the fourth quarter. The nine months ended September 30. We achieved $51 million in sales for the product.

接下來是第 5 張投影片，快速瀏覽我們迄今為止在美國推出 AUCATZYL 的表現。第三季度，我們的淨銷售額達到 2,110 萬美元，遞延收入為 760 萬美元，這表明截至第三季末，中心內有大量產品尚未輸注，準備在第四季度輸注。這九個月截至9月30日。該產品銷售額達5,100萬美元。

When we look at how we're executing on product delivery and patient access, we're tracking very well. We had, at the beginning of the year, told you that we're targeting to authorize 60 centers by the end of this year. We achieved that goal, so we're at 60 centers today, and we will keep adding additional centers to fill out the geographic gaps that we're having across the US, and with that, minimize the travel distances for patients to access therapy.

從產品交付和患者獲取方面的執行情況來看，我們做得非常好。今年年初，我們曾告訴你們，我們的目標是在今年年底前授權設立 60 個中心。我們已經實現了這個目標，所以現在我們有 60 個中心，我們將繼續增加中心，以填補我們在美國各地存在的地理空白，從而最大限度地減少患者接受治療的出行距離。

The manufacturing success rate is well above 90%, and we have attained patient access for more than 90% of US covered lives. So this gives us a very strong foundation, both from a rollout perspective, but also from a dynamic perspective, as we're sort of looking into the fourth quarter and into 2026.

生產成功率遠高於 90%，我們已經為超過 90% 的美國參保人員實現了病患用藥。因此，無論從推廣的角度來看，還是從動態的角度來看，這都為我們奠定了非常堅實的基礎，因為我們正在展望第四季以及 2026 年。

Moving to slide 6, we believe there's a significant opportunity to increase the penetration and grow the CAR T market share. When we look at the level of CAR T market, CAR T use, before our product entered commercialization in 2024, we're seeing about 15% market share for CAR T therapies in this indication.

翻到第 6 張投影片，我們認為 CAR-T 的滲透率有很大的機會提高，市佔率也有很大的成長空間。當我們觀察 CAR T 市場水準和 CAR T 使用情況時，在我們的產品於 2024 年進入商業化之前，我們看到 CAR T 療法在該適應症中的市佔率約為 15%。

When we look in the treatment centers, the 60 treatment centers that we're active in now, which actually cover the vast majority of the relapsed/refractory ALL patients, we believe that the market share within that group of 60 centers at this point is probably around 20%. This gives us an opportunity for substantial growth within the centers that we're already present in and the footprint we already built. This is about relationship building and deepening those relationships to really drive the uptake further and actually drive towards the types of levels of uptake that we've seen a few years ago within sight to achieve in this particular indication.

當我們審視我們目前活躍的 60 個治療中心時，這些中心實際上涵蓋了絕大多數復發/難治性 ALL 患者，我們認為，目前這 60 個中心的市場份額可能在 20% 左右。這為我們提供了在現有中心和已建立的業務範圍內實現大幅成長的機會。這關乎建立和深化關係，從而真正推動推廣，並朝著幾年前我們在這個特定適應症中看到的推廣水平邁進。

The importance, I think, of the experience that the physicians are making with the product really cannot be overstated. The actual hands-on experience is critical here, and we believe that the way that we're seeing the product perform and also what we're seeing being reported or planned to be reported at ASH from the ROCCA Consortium indicates that there is a very positive experience that the physicians are making with the product consistent with the experience that we have gained through our development and in particular also within our registration study, the FELIX study.

我認為，醫生在使用產品過程中所獲得的經驗的重要性怎麼強調都不為過。實際操作經驗至關重要，我們相信，從我們目前所看到的該產品的性能，以及 ROCCA 聯盟在 ASH 大會上報告或計劃報告的內容來看，醫生們對該產品有非常積極的體驗，這與我們通過研發，特別是通過註冊研究 FELIX 研究所獲得的經驗相一致。

Moving to slide number 7. We're going now, focusing -- we had a quick look at the launch. We're now focusing on the key approaches here that we're looking to optimize our operation and really improve the overall margins and efficiencies. When we look at slide number 8, first, a quick look at changes that we have made within the leadership team. We have three new key members in the team that joined us during the course of the third quarter.

轉到第7張投影片。我們現在要走了，集中精力——我們快速瀏覽了一下發布會。我們現在專注於關鍵方法，希望優化運營，真正提高整體利潤率和效率。當我們來看第 8 張投影片時，先快速看一下我們在領導團隊內部所做的改變。第三季期間，我們團隊新增了三位關鍵成員。

First off, Miranda Neville, who some of you may actually have met in the past, has been actually with the company for about five years and initially worked on the planning and setup of the Nucleus facility; then actually took over the overall program team for obe-cel and drove the program through the registrations and getting us the approvals in the US, in Europe, and also in the UK; and now actually returns back to product delivery in the role of Chief Technology Officer leading the entire team.

首先，米蘭達·內維爾（Miranda Neville），你們中的一些人可能以前見過她，實際上已經在公司工作了大約五年，最初參與了 Nucleus 工廠的規劃和建設；然後接管了 obe-cel 的整個項目團隊，推動該項目完成了註冊，並在美國、歐洲和英國獲得了批准；現在，她以首席技術官的身份回歸

Cintia Piccina has taken over from Brent Rice as the US Chief Commercial Officer and Country Manager. and has an extensive set of experience in oncology, in immunology, but most importantly for us, in cell and gene therapy. She has an extensive experience launching products in this space and we believe is extremely well-positioned to actually grow the opportunity for AUCATZYL from here forward.

Cintia Piccina 接替 Brent Rice 擔任美國首席商務官兼國家經理，她在腫瘤學、免疫學領域擁有豐富的經驗，但對我們來說最重要的是，她在細胞和基因治療領域也擁有豐富的經驗。她在該領域擁有豐富的產品上市經驗，我們相信她完全有能力從現在開始真正擴大 AUCATZYL 的發展機會。

And then Patrick McIlvenny, who's taken over from Andrew Mercieca as the Chief Accounting Officer reporting into Rob Dolski. Patrick joins us from Horizon Pharma, where he's been going through the very significant growth that that company went through and also increase in complexity and believe has an excellent background to really help us actually go through the next phase of optimization and also of growth for the company.

然後是帕特里克·麥克伊爾文尼，他接替安德魯·默西卡擔任首席會計官，向羅布·多爾斯基匯報工作。Patrick 先前在 Horizo​​​​n Pharma 工作，他親身經歷了該公司的顯著增長和日益複雜的運營，並相信他擁有豐富的經驗，能夠真正幫助我們進入公司下一個優化和增長階段。

Now I would like to sort of highlight also the three members of our team that actually handed over the responsibilities to Miranda, Cintia, and Patrick. Dave Brochu, who's been the Chief Technical Officer, handing over to Miranda, has done an excellent job building our product delivery team, building also the Nucleus facility, taking it into operation, and launching the product. It was a huge accomplishment to actually go through that entire growth phase and building that entire part of the operation from the ground up. And there's a huge thanks that goes to Dave for that incredible achievement.

現在，我還想重點介紹我們團隊的三位成員，他們實際上把責任移交給了米蘭達、辛蒂婭和帕特里克。戴夫·布羅丘（Dave Brochu）擔任首席技術官，並將職位移交給米蘭達（Miranda）。他在組建產品交付團隊、建造 Nucleus 工廠、使其投入營運以及推出產品方面都做得非常出色。真正經歷整個成長階段，從零開始建立起整個營運體系，這是一項巨大的成就。在此，我們要衷心感謝戴夫所取得的這項驚人成就。

Brent Rice, a predecessor of Cintia, has done a fantastic job building a very strong commercial team. The systems required and actually executed an excellent launch of the product and getting us really rolling now, I think, in a way that is quite remarkable and gives us, I think, a great outlook as we're sort of looking into 2026 now under the leadership of Cintia. And also Andrew Mercieca had built obviously a lot of the infrastructure pieces from a corporate side perspective that Patrick's now taken over, and also a great thanks going to Andrew as well.

Cintia 的前任 Brent Rice 在組建一支非常強大的商業團隊方面做得非常出色。這個系統確實出色地完成了產品發布，並讓我們真正開始運轉起來，我認為這非常了不起，也讓我們對未來充滿信心，因為在 Cintia 的領導下，我們現在正展望 2026 年。此外，Andrew Mercieca 顯然從公司層面建立了許多基礎設施，現在 Patrick 接手了這些工作，也非常感謝 Andrew。

So with that, I'd like to move to slide number 9 and just a few thoughts in terms of the ability to really drive efficiencies and cost savings. I think where we are is that we have now built a very strong foundation through the strong launch performance with a highly reliable product supply. That's been the critical piece that we had to actually build and establish this year and frankly has been a very significant challenge for most companies launching cell therapy and in particular CAR T products.

接下來，我想轉到第 9 張投影片，談談如何真正提高效率和節省成本。我認為我們現在所處的位置是，憑藉強勁的上市表現和高度可靠的產品供應，我們已經建立了一個非常堅實的基礎。這是我們今年必須建立和建立的關鍵部分，坦白說，這對大多數推出細胞療法，特別是 CAR T 產品的公司來說，都是一個非常重要的挑戰。

Having established that now gives us an ability also with all the learnings that come out of that experience to really streamline the processes. The training wheels can go off and we can now focus on making sure that we're just simple -- that we're as simple as possible, as straightforward as possible in terms of the processes that we run; take those processes that we decided that are necessary, optimize them, and automate them to the extent we can; and importantly, innovate.

既然已經取得了這樣的成果，我們就能結合從經驗中獲得的所有教訓，真正簡化流程。我們可以擺脫輔助輪，現在專注於確保我們的流程盡可能簡單——盡可能簡單、盡可能直接地運行流程；對我們認為必要的流程進行優化，並儘可能實現自動化；更重要的是，要進行創新。

And one of the two key areas that we're planning to and we're focusing to innovate on is really on manufacturing, where there's a lot of activity going on, on technology, on automation, but also on the biology side and on market access to make sure that we can actually increase the footprint -- the geographic footprint for the product and the ability to actually serve a substantially larger group of patients going forward.

我們計劃重點創新的兩個關鍵領域之一是製造領域，該領域正在進行大量的創新活動，包括技術、自動化，以及生物學方面和市場准入，以確保我們能夠真正擴大產品的地域覆蓋範圍，並有能力在未來服務更多患者。

So with that, I'd like to go to slide number 10, and we're now actually moving forward looking at the opportunities to expand the potential for and realize the potential of obe-cel in additional sets of indications. With that, heading to slide 11, a quick overview of the clinical trials that are ongoing to expand the use of obe-cel in additional sets of indications.

那麼，接下來我想轉到第 10 張投影片，我們現在將著手研究如何擴大 obe-cel 的潛力，並在其他適應症領域實現其潛力。接下來，請看第 11 張投影片，快速概述正在進行的臨床試驗，以擴大 obe-cel 在其他適應症中的應用。

We're starting with the pediatric B-ALL study called CATALYST that is ongoing. We are reporting the Phase 1 portion of that trial at ASH, and we also have just received a few weeks ago an RMAT designation for the program as well. We're in the process of starting up the Phase 2 portion of this trial, and we're excited about the opportunity and obviously the opportunity to share the initial experience from our Phase 1.

我們首先要介紹的是正在進行的名為 CATALYST 的兒童 B 細胞急性淋巴性白血病 (B-ALL) 研究。我們將在 ASH 會議上報告該試驗的第一階段部分，而且就在幾週前，我們還獲得了該計畫的 RMAT 資格。我們正在啟動這項試驗的第二階段，我們對此機會感到非常興奮，當然也很高興有機會分享我們在第一階段的初步經驗。

The second study is the CARLYSLE study in severe systemic lupus patients. We had initial data presented at ACR, and I'll briefly talk about that in the upcoming slides. And we are planning for an oral presentation at ASH with a slightly expanded data set. Lupus nephritis is the focus for our first pivotal study in autoimmune disease. The study is called LUMINA, and we expect to have the first patient in the study before the end of the year. And then finally, our exploratory Phase 1 study in progressive multiple sclerosis called BOBCAT. BOBCAT started in the third quarter, and we had our first patient dosed in October.

第二項研究是針對重度系統性紅斑狼瘡患者的 CARLYSLE 研究。我們在 ACR 上展示了初步數據，我將在接下來的幻燈片中簡要介紹。我們計劃在 ASH 會議上作口頭報告，並提交一份略微擴展的資料集。狼瘡性腎炎是我們首個自體免疫疾病關鍵性研究的重點。這項研究名為 LUMINA，我們預計在年底前迎來第一位受試者。最後，我們還有一項名為 BOBCAT 的探索性 1 期研究，旨在研究進行性多發性硬化症。BOBCAT 計畫於第三季啟動，我們的第一位患者於 10 月接受了治療。

Now in addition to the internal studies, we obviously are going to support the investigator-sponsored trials, exploring the use of AUCATZYL in front-line settings. But also, our OC will follow the real-world experience that the ROCCA Consortium is collecting for obe-cel in relapsed/refractory adult ALL. And it's truly a reflection of the real-world experience of our customers, collected by them and analyzed by them.

除了內部研究之外，我們顯然還將支持研究者發起的試驗，探索 AUCATZYL 在第一線治療中的應用。此外，我們的 OC 將遵循 ROCCA 聯盟正在收集的關於 obe-cel 在復發/難治性成人 ALL 中的真實世界經驗。這真實反映了我們客戶在現實世界中的體驗，由他們收集和分析。

So with that, we're going to slide number 12 and just a few words on the data that we actually presented at the ACR conference in Chicago just at the end of October. We did present the experience that we had with the product at the 50 million fixed dose level that we have evaluated in six patients. These patients are patients with very advanced disease, very high SLEDAI scores at inclusion, very significant impact on their kidney function.

接下來，我們將翻到第 12 張投影片，簡單介紹一下我們在 10 月底於芝加哥舉行的 ACR 會議上展示的數據。我們介紹了我們在 5000 萬固定劑量水平下對六名患者進行評估後獲得的產品經驗。這些患者病情非常嚴重，入院時 SLEDAI 評分非常高，腎功能受到非常顯著的影響。

We have at least six months of follow up with the patients that we've reported on, and we have seen that five out of the six patients achieved DORIS remission. We have 50% of three of six achieved a complete renal remission. And we have no evidence of new disease activity up to 14 months of follow up, and the patients do not receive any lupus-directed therapy. Also, obviously when you have or in a DORIS remission, the steroid levels that patients may receive are at or below 5 milligrams per day.

我們對報告的患者進行了至少六個月的隨訪，結果顯示，六名患者中有五名達到了 DORIS 緩解。六名患者中有三名（50%）實現了完全腎臟病緩解。在長達 14 個月的追蹤中，我們沒有發現新的疾病活動跡象，而且患者也沒有接受任何針對狼瘡的治療。另外，顯然，當患者處於 DORIS 緩解期時，患者每天接受的類固醇劑量為 5 毫克或更低。

The safety profile with the product was very positive. The patients had no ICANs, no high-grade cytokine release syndrome, no DLTs at the 50 million cell dose level. PK and biomarkers, we showed a quick B cell depletion after infusion. We saw then obviously that at the point when the CAR T cells stopped persisting that the B cells started to recover. And we do see a predominance of naive B cells and reconstitution. More of that data is expected to be shown at ASH.

該產品的安全性非常好。患者在 5,000 萬個細胞劑量下沒有出現 ICAN、高等級細胞激素釋放症候群或 DLT。透過藥物動力學和生物標記檢測，我們發現輸注後 B 細胞迅速耗竭。我們當時很明顯地看到，當 CAR T 細胞停止持續存在時，B 細胞就開始恢復。我們確實看到幼稚 B 細胞和重建細胞占主導地位。預計在ASH會議上將公佈更多相關數據。

When we look in terms of now the next steps with the study, there are two directions that we're sort of exploring further. One is actually at 50 million cell dose adolescent patients aged 12 to 17. For a lot of these patients with early onset of lupus, they have a particularly challenging course of the disease, and there's a very significant medical need. In fact, when you look at the population, the highest medical need is in the youngest patients.

當我們展望這項研究的下一步時，我們正在進一步探索兩個方向。其中一項研究對象為 12 至 17 歲的青少年患者，劑量為 5,000 萬細胞。對於許多早期發病的狼瘡患者來說，他們的病情發展尤其具有挑戰性，存在著非常大的醫療需求。事實上，從人口角度來看，醫療需求最高的是年齡最小的患者族群。

So this will be explored at 50 million cell dose, which is obviously equivalent to, as you may remember, the pediatric level that we would use and just translate it into a fixed dose level. And we're also exploring one additional dose level on the adult side to sort of round out the experience in the SLE patients. The recommended Phase 2 dose is already defined as 50 million cells.

因此，我們將以 5000 萬個細胞的劑量進行研究，這顯然相當於，正如您可能記得的那樣，我們將使用的兒科劑量水平，並將其轉換為固定劑量水平。我們也在成人方面探索一個額外的劑量水平，以完善 SLE 患者的治療體驗。建議的二期臨床試驗劑量已確定為 5,000 萬個細胞。

Moving to the next slide, slide 13. This is a more detailed look at the safety for the product. And as you can see, it's a very good safety profile, no ICANs. We only had observed one Grade 1 CRS in half of the patients, a relatively short period of neutropenia following lymphodepletion, which was resolved by day 22. No high-grade infections that we have observed in the patients. And not unusual for patients that have significant kidney involvement, we have seen five patients with transient hypertension. Three had preexisting hypertension of the five.

接下來是下一張投影片，第 13 張投影片。這是對該產品安全性的更詳細分析。正如你所看到的，它的安全性非常好，沒有ICAN。我們只在半數患者中觀察到 1 級 CRS，即淋巴細胞耗竭後相對較短的中性粒細胞減少症，該症狀在第 22 天得到緩解。我們未在患者中觀察到任何高級別感染。對於腎臟受累嚴重的患者來說，出現短暫性高血壓的情況並不少見，我們已經看到 5 例患者出現短暫性高血壓。五人中有三人患有高血壓。

When we now look on slide 14, this is a view of the SLEDAI scores and the progression of the SLEDAI scores over time, looking at each individual patient. And what we're looking at, if you look at the screening bars, which are on the left-hand side of the respective charts, you can see that every one of these patients had a significant kidney component. This is the blue part of the bar.

現在我們來看第 14 張投影片，這裡展示了 SLEDAI 評分以及 SLEDAI 評分隨時間推移的變化情況，並針對每位患者進行了分析。我們看到的是，如果你看一下各個圖表左側的篩檢條，你會發現這些病人都有明顯的腎臟問題。這是長條圖中的藍色部分。

And then the other colors actually relate in part to increased DNA binding, as well as low complement, which is the black and the yellow. And the other colors actually are linked to other forms of autoimmune manifestation and inflammatory processes, whether this would be mucosal ulcers, rashes, arthritis, alopecia that we have seen in these patients.

其他顏色實際上與 DNA 結合增加以及互補性降低有部分關係，黑色和黃色就是這種情況。而其他顏色實際上與自體免疫表現和發炎過程的其他形式有關，例如我們在這些患者身上看到的黏膜潰瘍、皮疹、關節炎、脫髮等。

So as you can see, these patients have not just actually a renal component; they have a multitude of disease manifestations. And you can see, as these patients progress over time, these manifestations actually are very quickly reduced. And we then actually see with a bit of a lag also in, as the majority of the patients, a reduction of the renal signal as well. So all very encouraging. What's important is, again, none of these patients actually had any form of relapse or flare.

所以正如你所看到的，這些患者實際上不僅僅患有腎臟疾病；他們還有多種疾病表現。你可以看到，隨著這些患者病情逐漸好轉，這些症狀實際上會很快減輕。然後，我們實際上也看到，稍有延遲之後，大多數患者的腎臟訊號也出現了減弱。所以一切都非常令人鼓舞。重要的是，這些患者實際上都沒有任何形式的復發或病情惡化。

So moving to the next slide, this is slide number 15. This is a quick look at the DORIS assessment that you can see that five out of six patients achieved a DORIS remission with a median onset of five months. And again, in terms of the steroid dose that by month six, all patients had steroids tapered to less than or equal of 5 milligrams per day, and no other lupus medication, of course.

接下來是下一張投影片，這是第 15 張投影片。快速查看 DORIS 評估結果，可以看到六名患者中有五名達到了 DORIS 緩解，中位緩解時間為五個月。再說一遍，就類固醇劑量而言，到第六個月，所有患者的類固醇劑量都逐漸減少到每天 5 毫克或更少，當然，也沒有服用其他狼瘡藥物。

Now when we look at the upcoming data presentations on slide 16 in oncology, pediatric ALL, poster presentation, Phase 1 experience from the CATALYST study, adult ALL first, an oral presentation from the FELIX trial looking at the impact of the product cell phenotypes or the actual features of the product and the linkage to the longer-term outcome in these patients. And then second, a poster, which is looking at CAR T-cell persistence at month three and the ability to actually predict outcome based on that data for these patients, the longer-term outcomes; again, experience from the FELIX study.

現在，我們來看看第 16 張幻燈片中即將公佈的腫瘤學數據，包括兒科 ALL、海報展示、CATALYST 研究的 1 期經驗、成人 ALL 首先、FELIX 試驗的口頭報告，該報告探討了產品細胞表型或產品的實際特徵以及與這些患者長期預後的聯繫的影響。其次，還有一張海報，展示了 CAR T 細胞在第三個月的持久性，以及根據這些數據預測這些患者的長期療效的能力；同樣，這是來自 FELIX 研究的經驗。

On the autoimmune side, as mentioned, we have an oral presentation for the CARLYSLE trial. And we just want to highlight the fact that the ROCCA Consortium has several presentations, one of which looks at the patient characteristics, toxicity response after real-world administration of both obe-cel and brexu-cel, alongside the same time horizon within those centers, which at least to my knowledge is probably the first time we're seeing basically data collection of two CAR Ts in the real-world setting in parallel.

在自體免疫方面，如同前面所提到的，我們將就 CARLYSLE 試驗進行口頭報告。我們想強調的是，ROCCA 聯盟有幾場報告，其中一場報告著眼於患者特徵、真實世界中使用 obe-cel 和 brexu-cel 後的毒性反應，以及這些中心相同的時間範圍，據我所知，這可能是我們第一次看到在真實世界環境中並行收集兩種 CAR-T 的數據。

With that, we're heading to financial results and heading over to Rob.

接下來，我們將進入財務業績部分，並請羅布發言。

Thanks, Christian, and good morning or good afternoon to everyone. It's my pleasure to review our financial results for the third quarter of 2025. I'll be moving in the slide deck to slide number 18. In the third quarter, net product revenue for the three months ended September 30, 2025, was $21.1 million, compared with $20.9 million in the second quarter. Our deferred revenue balance at the end of Q3 with $7.6 million compared to $2.1 million in Q2. As a reminder, the deferred revenue balance represents products delivered to the authorized treatment centers but not yet infused for the purposes of revenue recognition in the P&L.

謝謝你，克里斯蒂安，也祝大家早安/下午好。我很榮幸能為大家回顧我們2025年第三季的財務表現。我將把投影片切換到第 18 張投影片。截至 2025 年 9 月 30 日的第三季度，淨產品收入為 2,110 萬美元，而第二季度為 2,090 萬美元。第三季末，我們的遞延收入餘額為 760 萬美元，而第二季末為 210 萬美元。提醒一下，遞延收入餘額代表已交付給授權治療中心但尚未輸注的產品，因此不計入損益表的收入確認。

Moving on to cost of sales in the third quarter, that amount totaled $28.6 million. As we've discussed previously, this amount includes the cost of all commercial product delivered to the authorized treatment centers, including the product delivered but not yet administered to patients; essentially, the manufacturing costs related to that deferred revenue I just mentioned.

接下來來看第三季的銷售成本，總額為 2,860 萬美元。正如我們之前討論過的，這個金額包括交付給授權治療中心的所有商業產品的成本，包括已交付但尚未給患者使用的產品；本質上，就是我剛才提到的遞延收入相關的製造成本。

Additionally, cost of sales includes any canceled orders in the period, patient access program product, inventory reserves or write-offs, third-party royalties for certain technology licenses, as well as idle capacity. Our expectation is to see cost-to-sales improvements as volumes increase and as we improve efficiencies in our own manufacturing operations, as Christian spoke about earlier.

此外，銷售成本包括該期間內取消的任何訂單、患者准入計劃產品、庫存儲備或註銷、某些技術許可的第三方特許權使用費以及閒置產能。正如克里斯蒂安之前所說，我們期望隨著銷售量的增加以及我們自身生產營運效率的提高，銷售成本率能夠得到改善。

Moving on, our research and development expense was $27.9 million for the three months ended September 30, 2025. That's compared to $40.3 million during the same period in '24. This change was primarily driven by the commercial manufacturing-related employee and infrastructure costs that has shifted from R&D into our cost-to-sales and inventory accounting.

接下來，截至 2025 年 9 月 30 日止的三個月內，我們的研發費用為 2,790 萬美元。相較之下，2024 年同期為 4,030 萬美元。這項變更主要是由於與商業製造相關的員工和基礎設施成本從研發轉移到了我們的銷售成本和庫存會計。

Our selling and general and administrative expenses increased to $36.3 million for the three months ending September 30, 2025, and that's compared to $27.3 million in the same period, 2024. This increase was primarily due to the salaries and other employee-related costs driven by increased headcount supporting our commercialization activities.

截至 2025 年 9 月 30 日的三個月，我們的銷售及一般及行政費用增加至 3,630 萬美元，而 2024 年同期為 2,730 萬美元。這一成長主要是由於員工人數增加，帶動了薪資和其他與員工相關的成本，以支持我們的商業化活動。

Our loss from operations for the three months ending September 30, 2025, was $71.6 million as compared to $67.9 million for the same period in 2024. And finally, net loss was $79.1 million for the three months ending September 30, 2025, reduced from a loss of $82.1 million for the same period in 2024.

截至 2025 年 9 月 30 日的三個月，我們的經營虧損為 7,160 萬美元，而 2024 年同期為 6,790 萬美元。最後，截至 2025 年 9 月 30 日的三個月淨虧損為 7,910 萬美元，低於 2024 年同期虧損 8,210 萬美元。

Our cash, cash equivalents, and marketable securities at September 30, 2025, totaled $367.4 million as compared to $588 million at the end of December 2024. This decrease is primarily driven by net cash views and operating activities and also impacted by a delayed cash receipt of approximately $20.1 million in our R&D tax credit from the UK HMRC.

截至 2025 年 9 月 30 日，我們的現金、現金等價物和有價證券總額為 3.674 億美元，而截至 2024 年 12 月底，這一數字為 5.88 億美元。這一下降主要受淨現金預期和經營活動的影響，同時也受到英國稅務海關總署 (HMRC) 研發稅收抵免款項約 2,010 萬美元延遲到帳的影響。

We continue to believe that with our current cash, cash equivalents, and marketable securities, we are well-capitalized to drive the launch and commercialization of obe-cel in relapsed/refractory adult ALL, and to generate data in the two pivotal trials in lupus nephritis and pediatric ALL, as well as the exploratory Phase 1 trial in MS.

我們仍然相信，憑藉我們目前的現金、現金等價物和有價證券，我們擁有充足的資金來推動 obe-cel 在復發/難治性成人 ALL 中的上市和商業化，並在狼瘡性腎炎和兒童 ALL 的兩項關鍵試驗以及 MS 的探索性 1 期試驗中生成數據。

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

現在我將把麥克風交還給克里斯蒂安，讓他簡要展望一下預期的里程碑。基督教？

Thanks, Rob. Moving to slide 20, we expect two, obviously, key data points from our key trials at ASH related to the pediatric study and the SLE CARLYSLE study. Also, there's the additional two presentations I already mentioned coming from the FELIX study. We then actually are in the startup, obviously, of two additional trials, the LUMINA trial and lupus nephritis, our Phase 2 study. And the ALARIC trial in patients with light-chain amyloidosis, which we're doing in collaboration with UCL. Both of those programs expected to have their first patient before year-end.

謝謝你，羅伯。接下來是第 20 張投影片，我們預計會收到來自 ASH 關鍵試驗的兩個關鍵數據點，分別與兒科研究和 SLE CARLYSLE 研究有關。此外，還有我之前提到的來自 FELIX 研究的另外兩份報告。接下來，我們實際上正處於另外兩項試驗的啟動階段，即 LUMINA 試驗和狼瘡性腎炎的第 2 期研究。還有我們正在與倫敦大學學院合作進行的針對輕鏈澱粉樣變性患者的 ALARIC 試驗。這兩個項目都預計在年底前迎來首例患者。

So with that, moving to slide 21, the focus is clearly for us to drive market share in adult ALL, improve margins, and expand beyond ALL. And with that, I think we're ready to open up for questions.

因此，接下來請看第 21 張幻燈片，我們的重點顯然是提高成人 ALL 的市場份額，提高利潤率，並擴展到 ALL 以外的領域。那麼，我想我們現在可以開始回答問題了。

Thank you. (Operator Instructions) Asthika Goonewardene, Truist Securities.

謝謝。（操作員指示）Asthika Goonewardene，Truist 證券公司。

Hey, guys. Good morning. Thanks for taking my question. I got a simple one. Can you just talk just a little bit about the patient flow that you're getting in here and the anticipated patient flow going forward? What proportion of these patients do you think are patients who might have been, who were, in the near term, were planned to give TECARTUS and were maybe had a treatment decision changed by the physicians to give AUCATZYL? Thank you.

嘿，夥計們。早安.謝謝您回答我的問題。我拿到的是一個簡單的。您能否簡單談談您目前的患者就診量以及未來預期的患者就診量？您認為這些患者中有多少比例是原本計劃在近期接受 TECARTUS 治療，但後來醫生改變了治療方案，改為接受 AUCATZYL 治療的患者？謝謝。

I'm not quite sure whether we have that level of resolution. What we do know is, first of all, that we have a good proportion of patients that clearly were not initially considered for CAR T therapy. And I think part of that, we're seeing expansion already of the prior market penetration in the space. Overall, we see, I think, very consistent access of the product, and I think very consistent use across the centers.

我不太確定我們是否具備那種解析度。我們首先知道的是，有相當一部分患者最初顯然沒有被考慮接受 CAR-T 療法。我認為部分原因是，我們已經看到該領域先前的市場滲透率有所擴大。總的來說，我認為，我們看到該產品在各個中心的使用和獲取都非常一致。

And we're looking forward to obviously getting with the additional centers that are open, so preparing, running through this quarter, but also preparing for 2026. And I think very excited with the dynamic we're seeing. And I think we'll have a nice, I think, reception of the additional data that we're expecting at ASH, including the real-world experience with the program.

我們當然期待與更多開放的中心合作，為此，我們不僅要準備並經營本季度，還要為 2026 年做好準備。我對我們目前看到的這種發展勢頭感到非常興奮。我認為，我們在 ASH 大會上將會收到令人滿意的額外數據，包括該專案的實際應用經驗。

Gil Blum, Needham & Company.

吉爾布魯姆，尼德姆公司。

Good morning, everyone, and thanks for taking our question. Just maybe a quick one on competitive positioning for obe-cel and pediatric patients. Is this a similar concept to what we're seeing in the adult relapsed/refractory patients, meaning differentiating on safety, or how are you thinking about this? Thank you.

各位早安，感謝你們回答我們的問題。或許可以簡單談談肥胖症患者和兒科患者的競爭定位。這與我們目前在成人復發/難治性患者中看到的區分安全性的概念類似嗎？或者您對此有何看法？謝謝。

Yes, thanks, Gil. Good question. So I think that the first part, I think, is to look at the actual patients that are eligible, pediatric patients that are eligible for CAR T therapy. And one of the key groups of patients that are actually not eligible for CAR T therapy are high-risk patients. So the patient population that we're focusing on certainly includes the high-risk patients as well.

是的，謝謝你，吉爾。問得好。所以我認為，第一步是要檢視符合條件的患者，也就是符合 CAR-T 療法條件的兒科患者。而實際上不適合接受 CAR-T 療法的關鍵患者群體之一是高風險患者。因此，我們關注的患者群當然也包括高風險患者。

What we do obviously know, and you've seen that from our prior publications going all the way back to the [CARPAL] study, in 2019, is that we do have obviously also in children a very good safety profile and a very good efficacy profile. I think having consistent, reliable access to product is absolutely critical with pediatric patients, and expanding the access to patients who are high-risk patients I think is particularly important because that's the group that currently has very limited options.

我們顯然知道，而且從我們先前的出版物，包括 2019 年的 [CARPAL] 研究，也可以看出，我們在兒童身上也明顯具有非常好的安全性和非常好的療效。我認為，對於兒科患者來說，持續、可靠地取得產品至關重要，而擴大高風險患者的取得途徑尤其重要，因為目前該族群可選擇的方案非常有限。

So that's kind of the key focus for the program and is, frankly, reflected also by, frankly, the physician interest that we have seen and received. And we're behind the decision that we took here also to move into the pediatric setting, understanding that there is a very significant need that they see for a product with the properties that they see for obe-cel.

所以這算是該計畫的重點，坦白說，這也從我們所看到和收到的醫生們的興趣中得到了體現。我們之所以做出進軍兒科領域的決定，也是因為我們理解兒科領域對具有像 obe-cel 那樣特性的產品有著非常大的需求。

Thank you. Very helpful.

謝謝。很有幫助。

Thanks, Gil.

謝謝你，吉爾。

Salim Syed, Mizuho Group.

Salim Syed，瑞穗集團。

Great. Congrats on the progress, guys. Christian, Rob, maybe just I'll ask one and then the follow up as well. I guess the first one. I'm thinking about 3Q over 2Q performance of AUCAT. Was there something in particular that drove the more or less flattish, especially since ATCs picked up quite meaningfully quarter over quarter? Are you starting to see some seasonality in the business with holidays, et cetera, and how does this relate all to 4Qs or pent-up demand there and there's deferred revenue? So that's question one.

偉大的。恭喜各位取得進展。克里斯蒂安，羅布，也許我會問一個問題，然後再問後續問題。我猜是第一個。我正在考慮AUCAT第三季相對於第二季的表現。是什麼因素導致了這種相對平穩的局面，尤其是在空中交通管制員（ATC）季度環比大幅增長的情況下？您是否開始注意到業務中存在一些季節性因素，例如假日等？這與第四季或積壓的需求以及遞延收入有何關係？這是第一個問題。

And then just on the follow-up question, on gross margins, Rob, curious how you're handling DNA in the COGS. We learned from Iovance this quarter that they had loaded a bunch of DNA into their COGS. They are now stripping it out to at least optically improve gross margins. Curious how much of your COGS is DNA or how you're exactly handling that. Thank you.

然後，關於毛利率的後續問題，Rob，我很好奇你是如何處理銷售成本中的 DNA 的。本季我們從 Iovance 了解到，他們已將大量 DNA 加載到他們的 COGS 中。他們現在正在剝離這部分成本，至少在表面上是為了提高毛利率。很好奇你們的COGS中有多少是DNA，或者你們是如何處理DNA的。謝謝。

All right. Well, thanks a lot. First off, questions related to sort of the sales numbers and possible seasonality in the fourth quarter. So as you remember, as we went through the second quarter, one of the things that we reported on is the fact that CMS had changed from precedence in terms of their reimbursement policy. And that required us to actually change our trade policy, adjust that, and it did lead to a reduction of patients enrolled in the second quarter, which meant that as we went into third quarter, we had a limited amount of product waiting to be infused and ready to go.

好的。非常感謝。首先，關於第四季度的銷售數據以及可能的季節性因素，有一些問題需要解答。如您所知，在第二季度，我們報道過的事情之一是，CMS 的報銷政策改變了以往的做法。因此，我們不得不改變貿易政策，進行調整，這導致第二季入組患者人數減少，這意味著進入第三季時，我們只有有限的產品可供輸注和使用。

And so we had an impact from that CMS decision and sort of the subsequent workup of that in the second half of the second quarter, but also going through the first half of the third quarter, because obviously the patients were not enrolled, they had not been manufactured. And obviously that had contributed to the performance that we were seeing for the third quarter as well. And we did highlight that also at the Q2 call that this is likely going to be the dynamic we're seeing.

因此，CMS 的這項決定以及隨後在第二季下半段和第三季上半場的後續工作都對我們產生了影響，因為很明顯，患者還沒有登記，也沒有生產出來。顯然，這也對我們第三季的表現產生了影響。我們在第二季財報電話會議上也強調了這一點，這很可能就是我們將看到的動態。

What is obviously very encouraging is when you look at the deferred revenue is that obviously we have had a very healthy amount of patients that actually got manufactured for and that were ready also then for infusion into the fourth quarter. So that's kind of, I think, tells us we're kind of behind that impact you have from CMS, which was sort of bridging between the second and the third quarter.

顯然，從遞延收入來看，非常令人鼓舞的是，我們已經為大量患者生產了藥物，這些藥物也準備好在第四季輸注。所以，我認為這說明我們有點落後於 CMS 的影響，CMS 的影響起到了連接第二季和第三季的作用。

In terms of seasonality in the fourth quarter, I think this is going to be our first fourth quarter we're going to be running. And so at this point, I don't think we can easily judge what the impact, what it might look like, if there is impact, and what it would look like. We're obviously going now into the Thanksgiving week in a short while, ASH conference, which also impacts a number of the physicians that we're working with, but also then obviously the Christmas break.

就第四季的季節性而言，我認為這將是我們第一次正常營運第四季。因此，在這一點上，我認為我們還不能輕易判斷其影響，如果存在影響，其影響會是什麼樣子。顯然，我們很快就要進入感恩節週，還有 ASH 會議，這也會影響我們正在合作的許多醫生，當然還有聖誕假期。

I think, at this point, it's hard to actually estimate. And we'll need to sort of actually go through that and actually gain that experience. I don't think there's something that's easy to sort of actually sort of estimate or adjudicate at this point. With that, I'm handing over to Rob for the growth margin question.

我認為，在目前這個階段，很難做出準確的估計。我們需要真正經歷這個過程，真正獲得那方面的經驗。我認為目前沒有什麼事情是容易估算或判斷的。接下來，我將把問題交給羅布，由他來回答成長率的問題。

So Salim, thanks for the question. So currently, with respect to any kind of deep depreciation amortization, it's kind of very typical accounting treatment. So you absolutely see depreciation from the Nucleus, the manufacturing facility, flowing through cost of sales. There are kind of non-cash stock-based comp that's also in there, as well as some commercial milestone amortization that occurs in the cost-to-sales line.

薩利姆，謝謝你的提問。所以目前，對於任何類型的深度折舊攤銷，這都是一種非常典型的會計處理方式。因此，您可以看到 Nucleus（製造工廠）的折舊完全計入銷售成本。其中也包含一些非現金的股票補償，以及一些計入銷售成本的商業里程碑攤提。

So we haven't broken that out. I think it's -- certainly, as we look into next year, we're already starting to think about how do we adjust or how do we think about communications for next year. And so it might be something that we can think through a little bit more. But right now, it's kind of presented the very typical standard way.

所以，我們還沒有把這部分單獨列出來。我認為——當然，展望明年，我們已經開始思考如何調整或如何看待明年的溝通方式。所以，這或許是我們可以再仔細思考的事情。但就目前而言，它的呈現方式非常典型且標準。

Okay. Thanks so much, guys.

好的。非常感謝各位。

Thank you.

謝謝。

Yanan Zhu, Wells Fargo Securities.

朱亞楠，富國證券。

Great. Thanks for taking our questions. I was wondering if you could talk about the CAR T share growth a little more as you alluded to in your prepared remarks. Where do you think the share growth will come from in the current kind of treatment landscape in B-ALL? And also, if you could comment on any front-line consolidation use that you see in the real world.

偉大的。謝謝您回答我們的問題。我想請您再詳細談談您在準備好的發言稿中提到的 CAR T 股份增長情況。在目前B-ALL的治療格局下，您認為市場佔有率的成長將來自哪裡？另外，如果您能就您在現實世界中看到的任何一線整合應用發表一下看法就更好了。

And maybe as a follow up, in terms of autoimmune diseases, can you give us an updated thinking on the lay of land based on new data from various CAR T players as well as bispecifics players, and how does that affect the positioning of obe-cel going forward? Thank you.

或許可以作為後續問題，就自體免疫疾病而言，您能否根據來自各種 CAR-T 療法參與者和雙特異性抗體參與者的新數據，為我們更新目前的情況，以及這將如何影響 obe-cel 未來的定位？謝謝。

Okay. Thanks, Yanan. I think these are three questions, so I'll try to tackle those in one go. So first of all, the question of growth, where can growth come from? I think what's important to understand is that when we look at the CAR T penetration at this point in time, in the relapsed/refractory adult ALL setting, at the centers that we're already present in, it is at approximately 20%.

好的。謝謝亞楠。我認為這是三個問題，所以我盡量一次回答它們。首先，關於成長的問題，成長從何而來？我認為需要理解的是，目前在復發/難治性成人 ALL 治療領域，在我們已進行治療的中心，CAR T 療法的滲透率約為 20%。

To put it differently, the majority of the patients at this point are not yet receiving CAR T therapy. And that gives you a significant opportunity for growth in the current centers that we're already active in. And that has to do, obviously, in a change of practice, because obviously these patients get treated today, typically without a transplant or other therapeutic modalities.

換句話說，目前大多數患者還沒有接受 CAR-T 療法。這為我們目前已開展業務的中心提供了巨大的發展機會。這顯然與實踐的改變有關，因為很明顯，如今這些患者通常無需移植或其他治療方式即可得到治療。

And so there is a significant opportunity to keep growing, for the centers to gain experience, for the physician to get comfortable with the treatment modality, and to grow from there into the broader set that's captured in our label. And that is currently, at this point, many of these patients receiving other types of treatment.

因此，對於各個中心來說，這是一個持續發展的巨大機會，可以累積經驗，讓醫生熟悉治療方式，並在此基礎上發展到我們標籤所涵蓋的更廣泛的領域。目前，許多這類患者正在接受其他類型的治療。

Obviously, what's very helpful here is the fact that the product is well manageable. It has a good safety profile. It's well manageable. And that builds confidence. So the experience that we think -- actually, well, one of the key elements of experience is obviously the safety, which is the immediate experience. But the second part is also that the centers have obviously started treating -- the early centers started treating patients in the first half of this year. They now start to actually get a feel for the longer-term outcome of these patients and the efficacy, not just the responses, but also the longer-term outcome.

顯然，這款產品易於管理這一點非常有幫助。它具有良好的安全性能。完全可以應付。這有助於建立自信。所以我們認為的體驗——實際上，體驗的關鍵要素之一顯然是安全，也就是直接的體驗。但第二點也是，這些中心顯然已經開始治療──早期的中心在今年上半年就開始治療病人了。他們現在開始真正感受到這些患者的長期療效和結果，不僅是反應，還有長期結果。

When we also believe that that visibility for those centers and the physicians of their own patients reaching longer-term outcomes, I think we'll actually have a reinforcing effect. And so those are the key parameters that we're working on. And it's not just the way that we're thinking about it. It's also when you look at the abstract from the ROCCA data or also then we'll see the actual presentation, you start to get a good sense of indeed that that's actually also reflecting very much of what the physicians are seeing and how they're thinking about the product.

當我們也相信，這些中心及其醫生能夠看到自己的患者取得長期療效，我認為這實際上會產生強化作用。所以，這些就是我們正在研究的關鍵參數。而且這不僅僅是我們思考這個問題的方式。當你查看 ROCCA 數據的摘要，或看到實際的演示時，你會開始清楚地意識到，這實際上也反映了醫生所看到的以及他們對該產品的看法。

Those physicians that actually have already gained substantial experience are thinking actually already quite a bit beyond the current setting, and they're considering running investigator-sponsored trials in the front-line consolidation setting. So that's already happening, which tells you something about what the perception is of these physicians, where the product actually should go in their view.

那些已經累積了相當豐富經驗的醫生，他們的思維實際上已經遠遠超越了當前的環境，他們正在考慮在一線鞏固治療環境中開展研究者發起的試驗。所以這種情況已經發生了，這說明這些醫生對產品應該走向何方的看法。

What we do not see, and I wouldn't expect to see, is actually any form of front-line use for an extended period of time. Because obviously, we do not have data in front-line setting, nor do we have the label in front-line setting. So it's not something that we expect to see for the upcoming period ahead of us, and certainly with more experience and potentially changes in guidelines that may change over time, but that will take time to develop.

我們沒有看到，而且我也不指望看到，實際上在前線長時間使用任何形式的武器。顯然，我們沒有一線環境下的數據，也沒有一線環境下的標籤。因此，我們預計在接下來的這段時間裡不會看到這種情況，當然，隨著經驗的累積和指導方針的可能變化，這種情況也需要時間來發展。

And then the last question is related to the competitive landscape in autoimmune disease. I think it was very interesting to see the data that was presented at the ACR conference. I think encouraging that there's been -- obviously, there's a good overall, I think, shared view across data that, indeed, the CAR T therapies, irrespective of the nature of the CAR T therapies, do give a positive outcome, provide positive outcome for patients with autoimmune disease.

最後一個問題與自體免疫疾病領域的競爭格局有關。我認為在ACR會議上展示的數據非常有趣。我認為令人鼓舞的是，顯然，從數據來看，總體上存在著一種良好的共識，即 CAR T 療法，無論 CAR T 療法的性質如何，確實能帶來積極的結果，為自身免疫性疾病患者帶來積極的結果。

However, when you look at the data more closely, you do see there's a lot of differences within the data sets. There's differences in terms of the patients and the severity that the patients actually have with their respective disease. And then we see differences in safety. We see flares coming up in independent programs and so on.

但是，當你仔細查看數據時，你會發現資料集之間有許多差異。患者本身以及他們所患疾病的嚴重程度都存在差異。然後我們看到了安全性方面的差異。我們看到獨立項目等方面出現了一些問題。

So it's worthwhile taking a closer look and actually look at the data and keep following the data as it evolves. But the sense that we have from our own data set is that we're actually stacking up very well with our data, both on safety as well as in efficacy. And we believe we're very well positioned in the indications that we've chosen to move into.

因此，仔細研究數據並持續關注數據的變化是值得的。但從我們自己的數據集來看，我們的數據實際上非常吻合，無論是在安全性還是有效性方面。我們相信，在我們選擇進入的這些領域，我們處於非常有利的地位。

In terms of other modalities beyond CAR T, there's very little data that was actually published. I would expect to see more data emerge during the course of next year. And it'll be interesting to see where some of that data lands. I would assume part of it will certainly be our programs that are looking to position against monoclonal antibodies and try to sort of basically go into that space.

除了 CAR-T 療法之外的其他療法，目前已發表的數據非常少。我預計明年將會出現更多數據。看看這些數據最終會得出什麼結果，將會很有意思。我估計其中一部分肯定是我們那些旨在對抗單株抗體並嘗試進入該領域的計畫。

As you remember, the way that we're positioning our product is actually after the patients have gone through monoclonal antibody therapy and sort of relapsed and have recurring disease after that. And so it is a more advanced group of patients that we're looking at, the patient that has actually at this point no approved treatment options. So it's a different form of severity and level of severity that we're actually developing in and so we may see different modalities at slightly different places as we see it today, starting with steroids, going to antimalarials, going to monoclonal antibodies.

您應該還記得，我們​​產品的定位其實是針對那些接受過單株抗體治療後病情復發的患者。因此，我們現在關注的是一群病情較嚴重的患者，也就是目前還沒有核准治療方案的患者。所以，我們實際上正在研究的是不同形式的嚴重程度和嚴重程度，因此，我們可能會在略有不同的地方看到不同的治療方式，就像我們今天看到的那樣，從類固醇開始，到抗瘧疾藥物，再到單株抗體。

We see that whole range in the calcineurin inhibitors. We see that whole range actually evolve and be positioned across the severity grade and the development of the disease. We're focusing on the most severe patients, where we think we can have very profound impact. That's the initial approach. And then, obviously, once we have data in that setting, we'll certainly consider to broaden out.

我們在鈣調磷酸酶抑制劑中看到了這種範圍。我們看到整個範圍實際上會隨著疾病的嚴重程度和發展而演變和定位。我們專注於病情最嚴重的患者，因為我們認為我們可以對他們產生非常深遠的影響。這是初步方案。然後，很顯然，一旦我們獲得了該環境的數據，我們一定會考慮擴大範圍。

Great. Thanks for all the insights.

偉大的。感謝您提供的所有見解。

Thank you very much.

非常感謝。

James Shin, Deutsche Bank.

James Shin，德意志銀行。

Hi, this is Sam on for James. I'm just wondering if you can provide more color on the data you're expecting at ASH?

大家好，我是Sam，替James為您報道。我只是想問一下，您能否詳細介紹一下您預計在ASH會議上獲得的數據？

Yes, happy to do that. Hi, Sam. Thanks for joining. So I did mention on the pediatric ALL study, that is obviously the Phase 1 experience. So we have around 20 patients' worth of data in that data set that we're going to be presenting in a poster. Obviously, it has longitudinal data, response data, safety data. So I think it'll give us a good view. And I think it'll be, I think, very clear why we decided to actually move forward into the second stage of that study, the Phase 2 stage of that study.

是的，我很樂意這樣做。嗨，山姆。謝謝參與。所以我提到了兒科 ALL 研究，那顯然是 1 期臨床試驗的經驗。所以，我們在這個數據集裡有大約 20 位患者的數據，我們將在海報中展示這些數據。顯然，它擁有縱向資料、回應資料和安全資料。所以我覺得它能給我們很好的視野。我認為，大家會很清楚地明白我們為何決定要推進研究的第二階段，也就是第二期研究。

With regards to the CARLYSLE study, the CARLYSLE study, obviously, we had the data presented in a poster of ACR that I just referenced earlier in the prepared remarks. We're going to expand on that data, certainly look at additional pharmacodynamic recovery data, et cetera, to sort of actually round out the picture and, I think, frankly, go through, one, the impact on the disease, but then also the ability of the immune system to reset without also the disease to recur. So that's going to be a key part of the focus of that presentation.

關於 CARLYSLE 研究，顯然，我們在 ACR 的海報中展示了 CARLYSLE 研究的數據，我剛才在準備好的發言稿中提到過。我們將擴展這些數據，當然還會研究額外的藥效學恢復數據等等，以真正完善整個情況，坦白說，我認為，首先要考察對疾病的影響，其次要考察免疫系統在不使疾病復發的情況下重置的能力。所以這將是那次演講的重點部分。

And then when we're looking at the product profile versus longer-term outcome, obviously an analysis we've done where we looked at a range of product parameters to see which one of these product parameters actually are tracking with long-term outcome. And I think that's going to be an interesting oral presentation, because it also has a substantial data set behind it. And with that, I think meaningful, I think, learnings from that analysis.

然後，當我們查看產品概況與長期結果時，顯然我們已經進行了一項分析，研究了一系列產品參數，以了解哪些產品參數與長期結果真正相關。我認為這將是一場有趣的口頭報告，因為它背後有大量的數據支撐。我認為，透過這些分析，我們可以獲得一些有意義的經驗教訓。

And then the final part is obviously when you actually induce a response in the ALL patients, you obviously would like to know whether -- or would like to have early information or indication about the likelihood that the patient will remain in remission going forward. And so the teams and the physicians have been looking at various parameters to see what might actually track. And one of the areas that they thought was interesting is to actually look at the persistence of the product at three months as sort of an indicator.

最後一部分顯然是，當你在 ALL 患者中實際誘發反應時，你顯然想知道——或者說，你希望獲得關於患者未來能否保持緩解的早期資訊或跡象。因此，各團隊和醫生一直在研究各種參數，看看哪些參數可能真正有效。他們認為有趣的一個面向是，實際觀察產品在三個月時的持久性，以此作為某種指標。

And so we'll need to see -- obviously, there's more analysis that is being conducted, but that's going to be a part of the focus of a particular poster presentation. So those, I think, are the key parts of the presentation. And then, as I pointed out, please go have a look at the various presentations from the ROCCA Consortium. I think, very insightful, and I think gives you a good sense for what the actual reception is of the product and why it resonates the way it does.

因此，我們需要看看——顯然，還有更多的分析正在進行中，但這將是某個海報展示的重點之一。所以，我認為，這些就是演講的關鍵部分。然後，正如我所指出的，請去看看 ROCCA 聯盟的各種簡報。我認為這很有見地，能讓你很好地了解產品的實際反應以及它為何能引起如此共鳴。

Thanks very much.

非常感謝。

Thank you.

謝謝。

Clara Dong, Jefferies.

克拉拉‧董，傑富瑞。

Hi, good morning. Thanks for taking our questions. So one for me. So you mentioned the potential pivotal studies in pediatric ALLs. So just wondering whether you've had any regulatory dialogue or what kind of interactions have you had with the FDA in terms of this pivotal trial and what would be the requirement for the trial to be pivotal? Thank you.

您好，早安。謝謝您回答我們的問題。所以，我選一個。所以您提到了兒童急性淋巴性白血病（ALL）的潛在關鍵性研究。所以我想知道您是否與FDA就這項關鍵性試驗進行過任何監管對話或互動，以及這項試驗要成為關鍵性試驗需要滿足哪些要求？謝謝。

Yes, thanks a lot, Clara, for joining. Much appreciated. Yes, of course, we reviewed the Phase 1 data with the agency and reviewed with them the trial design, which is a trial design that we have developed with COG, the Children's Oncology Group, the leading oncology group in the US. And there's been agreement that, first of all, that the medical need in the high-risk patients, obviously, is significant, and that it would be beneficial to actually have a product that actually could include these patients in therapy. and provide a therapeutic option.

是的，非常感謝克拉拉的參與。非常感謝。是的，當然，我們與監管機構一起審查了 1 期數據，並與他們一起審查了試驗設計，該試驗設計是我們與美國領先的腫瘤組織——兒童腫瘤協作組 (COG) 共同製定的。各方一致認為，首先，高風險患者的醫療需求顯然十分顯著，如果能有一種產品能夠真正將這些患者納入治療範圍，並提供治療選擇，那將是有益的。

So very clear conversation around the patient population, the type of data that we need to have, as well as the size of the study. So very consistent, and it was only after we had those conversations and we had clarity on the path forward that we actually communicated that, indeed, this is what we're going to do, which I think is what we did for the first time at the Q2 call.

因此，圍繞著患者群體、我們需要的資料類型以及研究規模，展開了非常清晰的討論。所以，我們一直非常堅持，只有在我們進行了這些對話，明確了前進的方向之後，我們才真正溝通說，這確實是我們要做的事情，我認為這是我們在第二季度電話會議上第一次這樣做。

Okay, thank you.

好的，謝謝。

Thank you.

謝謝。

Matt Phipps, William Blair.

馬特·菲普斯，威廉·布萊爾。

Great. Sorry for the technical issues. This is Madeleine on for Matt. Thanks for taking the question. For the pediatric opportunity, do you have any rough timelines at this point for completing the pivotal cohort? And then related to that, what do you think is sort of the total market opportunity across both adult and pediatric ALL patients? Thank you.

偉大的。抱歉，出現了技術問題。這是 Madeleine 為 Matt 主持節目。感謝您回答這個問題。對於兒科項目，目前是否有完成關鍵隊列的大致時間表？那麼，與此相關的是，您認為成人和兒童 ALL 患者的整體市場機會如何？謝謝。

Thanks, Madeleine, for joining. So with regards to the pediatric opportunity, we do believe that when you look at the current medical needs segment, it's about 1,000 patients all in between Europe and US. So it's about 500 in the US. And a good proportion of these patients are in the high-risk category, and they're currently not being treated or not actually having direct access to CAR T therapy. So we would expect that we'd be able to sort of capture and support that part as well as having an opportunity to sort of actually broaden out the use of the product more broadly across the population.

謝謝瑪德琳的參與。所以就兒科市場而言，我們認為，從目前的醫療需求來看，歐洲和美國共有約 1000 名患者。所以美國大約有500人。而這些患者中有相當一部分屬於高風險族群，他們目前沒有接受治療，或實際上無法直接獲得 CAR-T 療法。因此，我們希望能夠抓住並支持這一部分，並有機會在更廣泛的人群中推廣該產品的使用。

I think at this point, I think it's not quite straightforward to give you a number. What we're seeing in general is I think there's an opportunity for a few hundred patients that could be actually reached through that type of a label. In terms of the study itself, we're starting up the Phase 2 portion of the study. We have, certainly in the Phase 1, seen a good rate of enrollment, and we hope that that will continue, and we expect that that is something we can actually build on in the Phase 2, so that we should actually be in the follow-up period, or get into the follow-up period in 2027, and hopefully have data maybe at the end of '27 or early '28.

我認為目前來說，給出一個確切的數字還不太容易。總的來說，我認為透過這種類型的標籤，實際上可以接觸到數百名患者。就研究本身而言，我們即將啟動研究的第二階段。在第一階段，我們已經看到了良好的入組率，我們希望這種情況能夠繼續下去，並且我們預計我們可以在第二階段以此為基礎繼續發展，以便我們能夠在 2027 年進入隨訪期，並希望在 2027 年底或 2028 年初獲得數據。

Thank you.

謝謝。

Thank you.

謝謝。

Shyam Kotadia, Goldman Sachs.

Shyam Kotadia，高盛集團。

Hi there. Shyam here from Goldman Sachs on behalf of Rojin. So I just had a question on AUCATZYL dynamics for the remainder of '25. So you mentioned already the CMS coding impact that impacted 3Q '25. So I just wanted to get a bit more color. Were you expecting revenues to be flat quarter on quarter, or was this above your expectations?

你好呀。我是高盛的Shyam，代表Rojin發言。所以，我有一個關於 AUCATZYL 在 2025 年剩餘時間內的動態問題。您之前已經提到 CMS 編碼對 2025 年第三季的影響。所以我只是想讓顏色更豐富一些。您是否預期本季營收與上季持平，還是超出了您的預期？

And therefore, given that the CMS lag was expected to be resolved in 4Q '25, how should we think about AUCATZYL sales for 4Q? Should we still expect to see some upside to 3Q, or would it likely be broadly flat? So that's the first one. And then a follow on, going forward, you've mentioned that you're entering a new phase of growth. So how should we think about AUCATZYL trajectory for 2026? Thank you.

因此，鑑於 CMS 滯後問題預計將在 2025 年第四季解決，我們應該如何看待 AUCATZYL 在第四季度的銷售額？我們是否仍應預期第三季會出現一些成長，還是很可能整體持平？這是第一個。然後，接下來，您提到您即將進入一個新的成長階段。那我們該如何看待 AUCATZYL 在 2026 年的發展軌跡呢？謝謝。

Thanks a lot for joining. Thanks for the question. So in terms of the Q3 dynamic, we did highlight already at the Q2 call that we expected to have an impact in terms of the recovery from the CMS event and actually going through that. And we did guide to, I think, relatively flat trajectory at that point in time, because we did know that there clearly was a lag in patients that were actually coming into the third quarter, which obviously was clear that would have an impact on the overall dynamic in the third quarter.

非常感謝您的參與。謝謝你的提問。因此，就第三季的動態而言，我們在第二季電話會議上已經強調，我們預計 CMS 事件的恢復以及實際經歷該事件將產生影響。我認為，當時我們確實引導了相對平穩的軌跡，因為我們知道，進入第三季度的患者數量明顯存在滯後，這顯然會對第三季的整體動態產生影響。

We saw that actually the second half of the quarter actually being fully reversed and actually the second half of the quarter actually running at the expected clip. For Q4, I don't think we're going to give guidance on Q4. The basic reason, as I mentioned before, is that this is the first time we're going through the end-of-the-year stretch with certainly Thanksgiving week, which leads to a slowdown typically at the clinics. ASH tends to have an impact, and then obviously the holiday season.

我們看到，實際上本季後半段的情況完全逆轉，實際上本季後半段的情況達到了預期水準。對於第四季度，我認為我們不會給出第四季度的業績指引。正如我之前提到的，基本原因是，這是我們第一次經歷年底的繁忙時期，尤其是感恩節那週，這通常會導致診所的業務放緩。ASH 往往會產生影響，當然還有節慶季。

So it's something that I think we just need to experience. We don't think that we have a good way to handicap that at this point and give a good sense around that, what to expect at this point. We're still in the first year of launch. There's a steep learning curve. And I think the fourth quarter certainly will be important to sort of understand the dynamic we're seeing there in the market, which is too early to call.

所以我覺得這是我們需要親身體驗的事情。我們認為目前還沒有很好的方法來預測這種情況，也無法很好地說明目前應該期待什麼。我們目前仍處於產品發布的第一年。學習曲線很陡峭。我認為第四季對於了解我們目前在市場中看到的動態至關重要，但現在下結論還為時過早。

Thank you.

謝謝。

Simon Baker, Redburn.

西蒙貝克，雷德本。

Thanks for taking my question. One related two-parter, if I may, please. Just going back to the question of revenues and deferred revenues, well, I think you said the deferred revenue balance was about $7.6 million. Could you just give us any idea as to how typical that is, if there are any factors in there? I'm just trying to get an idea of is this simply effectively the timing of the back end of the quarter just from when you book it, it just gets into the next, or whether there are any other factors within that? Just really from a modeling perspective.

謝謝您回答我的問題。如果可以的話，請再補充一個相關的兩部分內容。回到收入和遞延收入的問題，我想你說過遞延收入餘額約為 760 萬美元。您能否簡要說明一下這種情況的普遍程度，以及其中可能存在的因素？我只是想了解一下，這是否只是指從你記帳到下一個季度結束的時間安排，還是其中還有其他因素？純粹是從建模的角度來看。

And then related to that, clearly at this stage, the cost of goods line is understandably noisy. But I just wondered if you could give us an idea of the underlying sequential trends here. Is it too early to be seeing an underlying improvement in gross margin? And over what time period do you expect to see an improvement in the gross margin? Thanks so much.

與此相關的是，顯然在現階段，商品成本線波動較大也是可以理解的。但我只是想知道您能否為我們介紹這裡的潛在發展趨勢。現在就斷言毛利率出現根本性改善是否為時過早？您預計毛利率會在多長時間內有所改善？非常感謝。

Yes, very good question, Simon. I'll start, and then I will hand over to Rob to sort of add to that. So first of all, with regards to revenue and preferred revenue, obviously one of the, I think, characteristics of this type of a therapy is that you obviously have quite a time period between the inclusion of a patient and apheresis of a patient and the actual dosing.

是的，西蒙，問得好。我先開始，然後交給羅布補充。首先，就收入和優先收入而言，我認為，這種療法的特點之一是，從納入患者到進行患者血液分離術再到實際給藥之間，顯然存在相當長的一段時間。

And what that does is that as you get towards the end of the quarter, you obviously continue to actually include patients. You manufacture for those patients. The products actually get released and then get shipped to the centers. Typically, when the product is at the centers, there's still scheduling to be done to get the patient in. You may have situations where the patient may have actually picked up an infection. If that's the case, then the patient first needs to sort of get rid of the infection before you could actually start the lymphodepletion and then the treatment.

這樣做的好處是，隨著季度接近尾聲，你顯然會繼續將患者納入其中。你為這些患者生產產品。產品實際發布後，會運送到各中心。通常情況下，當產品到達中心後，也需要安排患者就診。可能會出現患者實際上已經感染的情況。如果是這種情況，那麼患者首先需要清除感染，然後才能開始淋巴清除和治療。

So there is a gap. There is a lag between. And depending on the condition of the patients, you may actually have a set of products that actually are shipped but not yet dosed. And so these sit basically at the center, and they're in the process of scheduling the patient or managing the patient through a crisis the patient may have experienced before the patient actually can receive the product.

所以這裡存在差距。兩者之間存在滯後。根據患者的具體情況，您可能實際上會有一批產品已經發貨，但尚未進行劑量配製。因此，這些人員基本上處於中心位置，他們負責安排患者就診或管理患者度過危機，以便患者在實際獲得產品之前能夠順利接受治療。

And it's only when the patient actually gets the product infused and, in fact, obviously, with the first and then the second infusion, that in fact the full payment actually becomes true and the revenue will be recognized in our numbers. So that's why there is a lack there. And while you have a buildup towards the end of the quarter, you have a good proportion of product that is either still finishing manufacturing or has already finished manufacturing, has been shipped.

只有當患者實際接受輸注產品後，而且顯然是在第一次和第二次輸注後，才能真正完成全部付款，收入才能在我們的財務報表中得到確認。所以這就是那裡出現短缺的原因。雖然季度末會出現積壓，但相當一部分產品要么仍在完成生產，要么已經完成生產並已發貨。

And it's that portion of the ones that are finished and shipped and received at the centers that go into the deferred revenue bucket. So that's the dynamic, and I think that's a dynamic we're just going to see. And it's sort of a reflection of the continuous flow of activity that we see quartering to from one quarter into the next quarter.

而那些已經完成、出貨並在中心收到的那部分收入，就計入了遞延收入。這就是目前的動態，我認為我們將會看到這種動態持續下去。這在某種程度上反映了我們從一個季度到下一個季度持續不斷的活動趨勢。

The COGS, to your point, obviously are noisy, and that's true. And obviously one of the key elements, particularly as you start, as you launch, is that you launch, obviously, initially have a number of patients going through your manufacturing setup. That is not obviously anywhere close to the setup that you actually designed for the larger opportunities. In other words, there is a significant portion of the infrastructure that is not actually utilized for commercial supply, particularly early on in the launch. And early on is still certainly within the first year of the launch.

正如你所說，COGS 顯然存在噪聲，這是事實。顯然，關鍵要素之一，尤其是在你開始、推出產品的時候，就是你最初要有一些病人來體驗你的生產設定。顯然，這與你為掌握更大機會而實際設計的方案相去甚遠。換句話說，相當一部分基礎設施實際上並沒有用於商業供應，尤其是在發射初期。而「早期」肯定是指產品上市後的第一年內。

And as you obviously then keep on growing the opportunity and you run more product through the facility, that's actually where your overhead cost, your overall cost for the facility obviously gets divided by a larger number. You see a decrease over time. So that's one dynamic. So volume is one of the key drivers that actually will reduce the actual cost of goods line overall and improves the ratio between revenue and cost of goods.

隨著機會的不斷增長，工廠生產的產品品質也隨之提高，實際上，工廠的營運成本（總成本）就會被更大的數字分攤。隨著時間的推移，你會看到下降。這是其中一個動態因素。因此，銷售量是降低整體商品成本並提高收入與商品成本比率的關鍵驅動因素之一。

The other part is actually the improvements in the actual operations itself. So in other words, in very simplistic terms, there's work that goes in, which are work hours, and there is materials that go in. And then there is some operating cost in terms of running the clean rooms. But time and the cost of materials are key elements.

另一部分實際上是實際營運本身的改進。換句話說，簡單來說，投入的有勞動（即工時），投入的材料也有勞動。此外，運作無塵室也需要一定的營運成本。但時間和材料成本是關鍵因素。

Cost of materials obviously is one of the drivers, so you actually drive down and you get more and more efficient. But one of the biggest elements that you actually look at and you look to improve on is the time you spend per product released. And that has a lot to do with experience, with optimizing your operating model, and actually really take all the experience we've now gained and take that and actually create, develop a more efficient operating model over time. And so that's a significant improvement process you're going to run through, and we are going to run through.

材料成本顯然是驅動因素之一，所以實際上你會降低材料成本，從而變得越來越有效率。但你真正需要專注並努力改進的最大要素之一，就是你為每個發布的產品所花費的時間。這與經驗有很大關係，與優化營運模式有關，實際上，要真正利用我們現在獲得的所有經驗，並隨著時間的推移，創造、發展出更有效率的營運模式。所以，這將會是一個你我都要經歷的重要改進過程。

And that gives us an ability to actually reduce on a per-batch basis the actual cost that is driven by actually producing this particular batch in terms of the work and the materials that go in. So those are key parameters that impact. So we expect to actually see, as we increase sales during the course of next year, we actually expect that we also see a decrease in the ratio of costs that we have or cost of sales versus what we're seeing in the first year of launch. So that's the dynamic we're looking at. And I'm handing over to Rob to sort of add on maybe some of the more technical accounting points.

這樣一來，我們就能夠逐批次地降低生產該批次產品所投入的人工和材料的實際成本。所以這些都是影響因素的關鍵參數。因此，我們預計，隨著明年銷售額的成長，我們的成本比率（即銷售成本）與產品上市第一年相比也會有所下降。這就是我們所看到的動態。接下來我將把麥克風交給羅布，讓他補充一些更專業的會計知識。

Yes, thanks, Christian. And thanks, Simon. The only thing I might add, I think Christian covered it very well, but I think you made the point. These are three quarters, three data points, and I would say that there's still a little bit of noise. And we've got to get to a more steady pattern, so to speak.

是的，謝謝你，克里斯蒂安。謝謝你，西蒙。我唯一想補充的是，我覺得 Christian 已經解釋得很清楚了，但我認為你已經表達清楚了。這是四分之三的數據，三個數據點，我認為仍然存在一些雜訊。我們必須建立更穩定的模式。

So to the CMS issue and to the Q2 and Q3 quarters that Christian talked about, the CMS really impacted the end of the Q2, early Q3. You actually saw that play through from a treatment perspective, even in some of the deferred revenue balance there. That's a difference between the finish that we have in the Q3 -- with Q3, that deferred revenue, we've recognized a much larger quantity, in fact, really quarter to quarter.

所以，關於 CMS 問題以及 Christian 提到的第二季和第三季度，CMS 確實對第二季末和第三季初產生了影響。實際上，從治療的角度來看，你甚至在一些遞延收入餘額中也看到了這一點。這與我們第三季的業績有所不同——第三季度，我們確認的遞延收入實際上比上一季多得多。

The main difference in our gross margin was driven by the amount of deferred revenue that we had to recognize the cost for. But that's also going to kind of give us a nice load, so to speak, with sales and gross margin going into Q4. We still have to play out the rest of the year. And again, Christian mentioned going through the first time with the holidays in ASH. So I just think that we need some more time and data point here to really see more of a smoothing effect in more of these quarter-over-quarter dynamics.

我們毛利率的主要差異是由我們需要確認成本的遞延收入金額所造成的。但從某種意義上說，這也將為我們帶來不錯的業績，尤其是在第四季的銷售額和毛利率方面。我們還要打完今年剩下的比賽。克里斯蒂安再次提到他在 ASH 第一次經歷假期。所以我認為我們需要更多的時間和數據點，才能真正看到這些季度比動態中更多的平滑效應。

Great. Thanks so much.

偉大的。非常感謝。

Thanks a lot, Simon.

非常感謝，西蒙。

Thank you. We'll now turn the call back over to Dr. Christian Itin for any closing remarks.

謝謝。現在我們將把電話轉回給克里斯蒂安·伊廷博士，請他作總結發言。

Well, thank you very much for joining us today. We're really looking forward to seeing you either at ASH through one or the other of the many data updates or then at the latest early in the year in San Francisco. I hope you're doing well and looking forward to connecting with you at one of those venues. Thank you. Bye-bye.

非常感謝您今天能來參加我們的節目。我們非常期待在 ASH 大會上見到您，屆時我們將進行眾多數據更新，或最遲在今年年初的舊金山與您見面。希望你一切都好，期待在其中一個場合與你見面。謝謝。再見。

This concludes today's conference call. Thank you for your participation and you may now disconnect.

今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接了。