Autolus Therapeutics PLC (AUTL) 2025 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Autolus second quarter 2025 financial results conference call. (Operator Instructions) Please be advised today's conference is being recorded.

您好，感謝您的支持。歡迎參加 Autolus 2025 年第二季財務業績電話會議。（操作員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your speaker today, Amanda Cray, Executive Director, Investor Relations, please go ahead.

現在，我想將會議交給今天的發言人，投資者關係執行董事 Amanda Cray，請繼續。

Thank you, Kevin. 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，凱文。大家早安，下午好，感謝你們參加今天的電話會議。與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 1995. These may include, but are not limited to, statements regarding status of the ongoing commercial launch of AUCATZYL; Autolus' 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.

我想提醒您，在今天的電話會議中，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。這些可能包括但不限於有關 AUCATZYL 正在進行的商業發布狀態的聲明；Autolus 的 AUCATZYL 製造、銷售和營銷計劃；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/或監管時間表和市場機會的狀態。

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 Investors section of our website.

這些聲明受到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陳述的義務。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. Rob will then discuss the financial results, and Christian will conclude with upcoming milestones and closing remarks. We'll then take questions.

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。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。然後我們將回答問題。

With that, I'll turn it over to Christian.

說完這些，我就把話題交給克里斯蒂安。

Thank you, Amanda. And moving to slide 4. Welcome, ladies and gentlemen, and thank you for joining us for the second-quarter call. We had an excellent second quarter with good momentum in our launch of AUCATZYL. In the second quarter, we generated $20.9 million in product sales, bringing the first six months of the launch to $29.9 million. The product profile resonates very well with treating physicians, and there is a clear unmet medical need. Our supply chain has proven to be robust, reliable, and delivering consistent quality to our customers.

謝謝你，阿曼達。轉到投影片 4。女士們、先生們，歡迎大家光臨，感謝你們參加我們的第二季電話會議。我們在第二季表現出色，AUCATZYL 的推出勢頭良好。第二季度，我們的產品銷售額達到 2,090 萬美元，上市後的前六個月銷售額達到 2,990 萬美元。該產品與主治醫生產生了很好的共鳴，並且明顯存在未滿足的醫療需求。事實證明，我們的供應鏈強大、可靠，並能為客戶提供一致的品質。

We continue to expand our center presence with now 46 centers authorized for use of AUCATZYL and 90% of total US medical lives covered. We are well on track to achieve our year-end objective of reaching 60 plus authorized centers.

我們繼續擴大我們的中心影響力，目前已有 46 個中心授權使用 AUCATZYL，涵蓋了美國 90% 的醫療總數。我們正在順利實現年底達到 60 多個授權中心的目標。

As of July 1, we have permanent HCPCS code effective, following a positive CMS decision on April 1. The decision by CMS of a split reimbursement based on the infusion of product was a deviation of precedence. The impact was twofold: a change in revenue recognition for the company and an adjustment of the administrative processes at the medical centers. The adjustments were made during the second quarter and did slow patient enrollment at those centers. We expect the impact on patients treated to be resolved by Q4.

根據 4 月 1 日 CMS 做出的積極決定，自 7 月 1 日起，我們的永久 HCPCS 代碼將生效。CMS 決定根據產品注入進行分攤報銷，這是先例偏差。其影響是雙重的：公司收入確認的變化和醫療中心行政流程的調整。這些調整是在第二季度進行的，確實減緩了這些中心的患者入院速度。我們預計對接受治療的患者的影響將在第四季度得到解決。

Moving to slide number 5. We're very pleased with the progress of our regulatory filings. In April, we received conditional marketing authorization in the UK and in July from the European Commission. We're working on market access in the UK and are interacting with NICE.

移至投影片 5。我們對監理備案的進展感到非常滿意。今年 4 月，我們獲得了英國的有條件上市許可，並於 7 月獲得了歐盟委員會的有條件上市許可。我們正在致力於英國的市場准入，並與 NICE 進行互動。

In the EU, we are looking at a country-by-country evaluation. While we aim to get AUCATZYL to as many patients as possible, as a small company with limited resources, we also have to be disciplined and make sure to only launch where market access is economically viable. At this stage, we do not expect EU sales in 2025 and 2026.

在歐盟，我們正在對各國進行評估。雖然我們的目標是讓盡可能多的患者能夠使用 AUCATZYL，但作為一家資源有限的小公司，我們也必須嚴格遵守紀律，確保只在經濟可行的市場准入領域推出產品。現階段，我們預期 2025 年和 2026 年歐盟的銷售額不會增加。

Meanwhile, we continue to engage with physicians and study groups, like the German ALL Study Group, to enable ISTs in Europe. In addition, we are broadening our real-world experience in the US with obe-cell, which may provide additional support for our market access conversations elsewhere.

同時，我們繼續與醫生和研究小組（如德國 ALL 研究小組）合作，以在歐洲推廣 IST。此外，我們正在透過 obe-cell 拓展我們在美國的實際經驗，這可能會為我們在其他地方的市場准入對話提供額外的支援。

Moving to slide number 6. The FELIX data continued to mature very favorably. At EHA, we presented an update with 32.8 months of median follow up. Importantly, 38% of the responding patients remain in remission without any subsequent treatment.

移至幻燈片 6。FELIX 數據繼續非常有利地成熟。在 EHA，我們公佈了中位追蹤時間為 32.8 個月的最新進展。重要的是，38% 的反應患者無需任何後續治療即可保持緩解狀態。

On slide 7, consistent with this finding, we see median duration of response reach 42.6 months.

在第 7 張投影片上，與這項發現一致，我們看到平均反應持續時間達到 42.6 個月。

Slide 8 then looks at the overall survival, which shows a plateau forming at around 40%, with most patients beyond two years of observation. A long-term outcome together with the favorable safety profile is a strong foundation to build on.

投影片 8 顯示了整體存活率，結果顯示整體存活率在 40% 左右形成平台期，大多數患者的觀察期超過兩年。長期結果加上良好的安全性是堅實的基礎。

Where next with obe-cel is summarized on slide 9. Our development focus is on expanding the of obe-cel beyond adult patients with relapsed refractory ALL. We made good progress with our pediatric study PY01. We expect the Phase 1 experience to be presented by the year end and are expanding the study from a Phase 1 to a Phase 1/2 study with an intent to expand the age range for our current label.

投影片 9 總結了 obe-cel 的下一步內容。我們的開發重點是將 obe-cel 的適用範圍擴大到復發難治性 ALL 成年患者之外。我們的兒科研究 PY01 取得了良好進展。我們預計第一階段的體驗將在年底前呈現，並將研究從第一階段擴展到第一/第二階段，旨在擴大我們目前標籤的年齡範圍。

Encouragingly, several of the physicians treating commercial patients expressed an interest in exploring obe-cel in frontline consolidation settings, and we expect to see several ISDs active in 2026.

令人鼓舞的是，幾位治療商業患者的醫生表示有興趣在前線整合環境中探索 obe-cel，我們預計 2026 年將有幾家 ISD 活躍起來。

We are also excited about our progress in autoimmune diseases. Building on the encouraging initial experience in SLE, we are starting up a Phase 2 lupus nephritis study with registrational intent. In addition, our Phase 1 study in progressive multiple sclerosis is open for enrollment now.

我們也對我們在自體免疫疾病方面的進展感到興奮。基於 SLE 領域令人鼓舞的初步經驗，我們正在啟動一項具有註冊意圖的 2 期狼瘡性腎炎研究。此外，我們針對進行性多發性硬化症的第一階段研究現已開放招募。

With that, I'm handing over to Rob for the financial results for the second quarter of 2025. Rob?

就這樣，我將把 2025 年第二季的財務表現交給 Rob。搶？

Thanks, Christian, And good morning, or good afternoon to everyone. It's my pleasure to review our financial results for the second quarter of 2025. In the second quarter, net product revenue for the three months ending June 30, 2025, was $20.9 million compared with $9 million in the first quarter. As Christian noted, we continue to be encouraged by AUCATZYL's uptake and strong momentum in the US.

謝謝，克里斯蒂安，大家早安，或下午好。我很高興回顧我們 2025 年第二季的財務表現。第二季度，截至 2025 年 6 月 30 日的三個月的淨產品收入為 2,090 萬美元，而第一季為 900 萬美元。正如克里斯蒂安所指出的，AUCATZYL 在美國的普及和強勁勢頭繼續令我們感到鼓舞。

Cost of sales in the second quarter total $24.4 million. As a reminder, this amount includes the cost of all commercial product delivered to the authorized treatment centers, including product delivered but not yet administered to patients. So again, as a reminder, the sales value of these products not yet recorded as product revenue in the P&L is reflected as deferred revenue on the balance sheet, and our deferred revenue balance at the end of Q2 was $2.1 million.

第二季銷售成本總計 2,440 萬美元。提醒一下，該金額包括運送到授權治療中心的所有商業產品的成本，包括已運送但尚未給患者使用的產品。因此，再次提醒一下，這些尚未在損益表中記錄為產品收入的產品的銷售價值在資產負債表上反映為遞延收入，而我們第二季末的遞延收入餘額為 210 萬美元。

Additionally, cost of sales includes any canceled orders in the period, our patient access program product, third-party royalties for certain technologies, as well as idle capacity. As expected, this dynamic will drive cost of sales to be higher at the beginning of the launch as we've experienced. And versus what we consider our ultimate target, our expectation is to see improvement as volumes increase and as we improve efficiencies in our own manufacturing operations.

此外，銷售成本包括該期間取消的任何訂單、我們的患者存取計劃產品、某些技術的第三方特許權使用費以及閒置產能。正如我們所預料的，這種動態將導致產品發布之初的銷售成本更高。與我們的最終目標相比，我們的期望是隨著產量的增加和我們自身製造業務效率的提高，看到業績的改善。

Moving on to research and development. These expenses decreased to $27.4 million for the three months ending June 30, 2025. That's compared to $36.6 million during the same period in '24. This change was primarily driven by the commercial manufacturing related employee and infrastructure costs that have shifted out of R&D expense into our cost of sales and inventory.

繼續進行研究和開發。截至 2025 年 6 月 30 日的三個月，這些費用減少至 2,740 萬美元。相比之下，24 年同期的營收為 3,660 萬美元。這項變更主要是由商業製造相關的員工和基礎設施成本所推動的，這些成本已從研發費用轉移到我們的銷售和庫存成本。

Our selling, general, and administrative expenses increased to $30.3 million for the three months ending June 30, 2025, and that's compared to $21.9 million in the same period in '24. This increase was primarily due to salaries and other employee related costs driven by increased headcounts supporting our commercialization activities.

截至 2025 年 6 月 30 日的三個月，我們的銷售、一般及行政費用增加至 3,030 萬美元，而 24 年同期為 2,190 萬美元。這一增長主要是由於支持我們商業化活動的員工人數增加而導致的工資和其他員工相關成本。

Our loss from operations for the three months ending June 30, 2025, was $61.2 million as compared to $58.9 million for the same period in 2024.

截至 2025 年 6 月 30 日的三個月，我們的營業虧損為 6,120 萬美元，而 2024 年同期為 5,890 萬美元。

During the quarter, we also recorded $12.1 million in net interest income and expense. This is primarily driven by a one-time non-cash adjustment to the liability related to the valuation of future royalties and milestones associated with the Blackstone and BioNTech agreements. The valuation assessment incorporated the revised commercial assumptions already discussed by Christian with respect to the EU launch.

本季度，我們也記錄了 1,210 萬美元的淨利息收入和支出。這主要是由於與 Blackstone 和 BioNTech 協議相關的未來特許權使用費和里程碑估值相關的負債的一次性非現金調整。估值評估納入了 Christian 就歐盟發布所討論的修訂後的商業假設。

And finally, net loss was $47.9 million for the three months ending June 30, 2025, reduced from a loss of $58.3 million for the same period in 2024. Our cash, cash equivalents, and marketable securities at Q2 2025 totaled $454.3 million as compared to $588 million at the end of December 2024. This decrease was primarily driven by net cash use in operating activities and also impacted by a delayed cash receipt of approximately $21.7 million in R&D tax credit that we've expected from the UK HMRC, which was expected to receive during the six months ending June 30, but has been delayed.

最後，截至 2025 年 6 月 30 日的三個月淨虧損為 4,790 萬美元，較 2024 年同期的 5,830 萬美元有所減少。截至 2025 年第二季度，我們的現金、現金等價物及有價證券總額為 4.543 億美元，而 2024 年 12 月底為 5.88 億美元。這一下降主要是由於經營活動中的淨現金使用，同時也受到我們預期從英國稅務海關總署獲得的約 2,170 萬美元研發稅收抵免的延遲現金收據的影響，這筆款項預計將在截至 6 月 30 日的六個月內收到，但已被推遲。

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 and to obtain data in the LN pivotal trial as well as MS Phase 1 study.

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，我們有足夠的資金來推動 obe-cel 的推出和商業化，並獲取 LN 關鍵試驗以及 MS 第 1 階段研究的數據。

I'll now hand back to Christian to wrap things up with a brief outlook on expected milestones for the rest of the year. Christian?

現在我將把時間交還給克里斯蒂安，讓他對今年剩餘時間的預期里程碑做一個簡要的展望。基督教？

Thanks a lot, Rob. So this gets me to kind of the outlook for the remainder of the year. The two data releases that we're planning, the first one is the updated data from our Phase 1 (technical difficulty) which we expect to provide the update at the ACR meeting at the end of October. And then we're aiming to provide a review of the Phase 1 data of our pediatric ALL experience towards the end of the year.

非常感謝，羅布。因此，這讓我對今年剩餘時間的前景有了一定的了解。我們計劃發布兩次數據，第一次是第一階段（技術難度）的更新數據，我們預計將在 10 月底的 ACR 會議上提供更新。然後，我們計劃在今年年底之前對我們的兒科 ALL 經驗的第一階段數據進行審查。

When we look at the clinical trial conduct, we expect first patients to be dosed for our lupus nephritis Phase 2 study, our MS Phase 1 study, and the AUTO8 study in amyloidosis, which is also expected to dose the first patient in the second half of the year.

當我們觀察臨床試驗的進行時，我們預計第一批患者將接受狼瘡性腎炎 2 期研究、MS 1 期研究和澱粉樣變性 AUTO8 研究的給藥，預計該研究也將在下半年對第一位患者進行給藥。

So a lot of progress and I think driving towards a very attractive dynamic on the launch, but also driving hard towards an expanded use of obe-cel beyond the relapsed refractory at adult ALL opportunity. And with that, I think we're in a great spot for the second half of the year.

因此，我認為取得了很大的進展，並且在推出時朝著非常有吸引力的動態發展，同時也在努力擴大 obe-cel 的使用範圍，使其超越復發難治性成人 ALL 的機會。因此，我認為我們今年下半年的情況非常好。

We're happy for you to actually join us for the Q&A session. Thank you.

我們很高興您能參加我們的問答環節。謝謝。

(Operator Instructions) James Shin, Deutsche Bank.

（操作員指示）德意志銀行的 James Shin。

First question is for Christian on the Germany launch. Was this originally a green light, call it, but flip to hold based on pricing and reimbursement changes from, say, the [MFN] under current? And then, I guess, the second one for Rob is, once the split reimbursement is, I guess, absorbed or embedded by the hospitals, then is enrollment and sales expected to accelerate? Or like what's the recognition pattern or cadence thereafter? Thank you.

第一個問題是關於克里斯蒂安在德國的發表會。這是否最初是一個綠燈，但根據現行的 [MFN] 定價和報銷變化而變為持有？然後，我想，對於 Rob 來說，第二個問題是，一旦分攤報銷被醫院吸收或嵌入，那麼入院人數和銷售額是否會加速成長？或是此後的識別模式或節奏是什麼樣的？謝謝。

Thanks a lot for joining, James. So what I think is important to understand in terms of the market access process in Europe in general is that the methodologies that are being used for market access are designed to use data from randomized controlled studies. And that has been a challenge, I think, for -- I think, many of the CAR-T programs and cell and gene therapy programs in general, which are based typically -- are placed in rare diseases initially, typically based on single-arm studies. So that's a methodological challenge that we do have across the board and across all of the assessing agencies and bodies. So that's, I think, first, the first observation. So there is a disjointedness, and with that, an element of a judgment call required.

非常感謝你的加入，詹姆斯。因此，我認為，就歐洲市場准入流程而言，重要的是要了解，用於市場准入的方法旨在使用來自隨機對照研究的數據。我認為這是一個挑戰，因為我認為許多 CAR-T 計畫以及細胞和基因治療計畫通常最初都是基於罕見疾病，通常是基於單臂研究。因此，這是我們所有評估機構和團體都面臨的方法論挑戰。所以，我認為這是第一個觀察。因此存在著一種脫節，因此需要進行一些判斷。

The second is clearly that we have to make sure that we are navigating, I think, the various processes such that we do get to an (inaudible) that is economically reasonable for us and doable for us. What we have seen in the past is that for certain products were launched below their actual production prices, which obviously is not a good precedent and doesn't really, I think, support a sustained business. And as a consequence, we've seen a substantial proportion of cell and gene therapy products actually not being launched in Europe. There's something like 8 out of 18 that were not launched.

第二，顯然我們必須確保我們正在引導各種流程，以便我們能夠實現對我們來說經濟合理且可行的目標（聽不清楚）。我們過去看到的情況是，某些產品的推出價格低於其實際生產價格，這顯然不是一個好的先例，而且我認為，這實際上不利於業務的持續發展。因此，我們發現相當一部分細胞和基因治療產品實際上並未在歐洲推出。大約有 18 個中 8 個尚未啟動。

So that's the backdrop. So we're going to do this very methodically, going to go through country by country and are navigating that. What is important to understand as well is obviously in the current environment that there is a number of countries actually do publish the actual negotiated prices. And you were pointing to [MFN], and you can imagine that also creates obviously a possible tension that may or may not be helpful in the process.

這就是背景。因此，我們將非常有條不紊地進行這項工作，逐一走訪各國並進行指導。同樣重要的是要理解，在當前環境下，顯然有許多國家確實公佈了實際談判價格。您剛才提到了[最惠國待遇]，您可以想像，這顯然也會造成一種可能的緊張局勢，這種緊張局勢可能對這一進程有幫助，也可能沒有幫助。

So we're going to take a very disciplined approach. We're going to engage with the respective countries, and we're going to work through the process. But we're also -- we'll certainly make sure that we're going to get to the right outcomes before launching, which is why we're sort of putting to a longer timeline before we realize any sales in Europe.

因此我們將採取非常嚴謹的方法。我們將與相關國家進行接觸，並努力完成這項進程。但我們也會——我們一定會確保在推出之前獲得正確的結果，這就是為什麼我們在實現歐洲任何銷售之前都會制定更長的時間表。

And with that, I'm handing over to Rob.

現在，我將把發言權交給 Rob。

Your question on the revenue recognition, so just to maybe clarify the specifics here. So we moved from the first quarter where ALL recognized -- was recognized on the first administration of obe-cel to a 50-50 split between the first administration and the second administration. At the time, we also called out that -- obviously, this is only for a portion of patients, CMS outpatients. And the time between those two time points was per the label about 10 days, plus or minus two days, I think in the field, we've seen about nine days thus far. So the specific implementation of the revenue recognition change, as we said at the time was going to have a very little impact, and we kind of see that as this quarter has even played out.

您的問題是關於收入確認的，所以也許只是為了澄清這裡的具體細節。因此，我們從第一季開始，在 obe-cel 的第一次管理中，所有人都得到了認可，而到了第一次管理和第二次管理中，認可度則達到了 50-50。當時，我們也指出——顯然，這只針對一部分患者，即 CMS 門診患者。根據標籤，這兩個時間點之間的時間大約為 10 天，加減兩天，我認為在現場，到目前為止我們已經看到了大約 9 天。因此，正如我們當時所說，收入確認變更的具體實施將產生很小的影響，我們認為這一影響在本季度已經顯現。

The adjustments that Christian referred to certainly that the centers had to make more on the administrative side and then in turn, impacting some of the registrations that were happening in that time frame, we really expect those to resolve themselves on kind of a full quarter basis by Q4, but we will see some of that certainly in Q2 and probably early in Q3.

克里斯蒂安提到的調整肯定意味著中心必須在行政方面做出更多調整，進而影響到該時​​間範圍內發生的一些註冊，我們確實希望這些問題能夠在第四季度以整個季度為基礎得到解決，但我們肯定會在第二季度甚至可能在第三季度初看到其中一些問題。

Thank you.

謝謝。

Matt Phipps, William Blair.

馬特菲普斯、威廉布萊爾。

I guess, Robert, quickly then, what happens if a patient only gets the first infusion? I realize this doesn't happen very often, but is there just an eventual time where you can recognize the rest of that? And then just thinking ahead, I'm sure no guidance here, but do you think you can become -- you can gross profit positive sometime by the end of this year or next year? Just wondering how we think about kind of that, getting over that fixed cost and getting to kind of capacity levels where you think we at least get to a gross profit level. Thank you.

羅伯特，我想，那麼，如果病人只接受第一次輸液，會發生什麼事？我知道這種情況並不常發生，但最終是否能讓你認識到其餘的事情？然後只是向前思考，我確信這裡沒有指導，但您認為您可以在今年年底或明年某個時候實現毛利為正嗎？只是想知道我們是如何看待這種情況的，克服固定成本並達到某種產能水平，您認為我們至少可以達到毛利水平。謝謝。

Thanks for joining, Matt. I'll take first the first question and hand over to Rob. So when you have the first infusion and only the first infusion, which is actually extremely rare, because obviously the only reason why that second infusion wouldn't happen if the patient would have an adverse event reaction, that wouldn't allow you to actually do the second dose.

感謝您的加入，馬特。我先回答第一個問題，然後交給 Rob。因此，當您進行第一次輸液並且僅進行第一次輸液時，這實際上極為罕見，因為顯然第二次輸液不會發生的唯一原因是如果患者出現不良事件反應，那就不允許您實際進行第二次劑量。

And you remember from our clinical experience, that is exceedingly rare. And in fact, we do see this very, very rarely in the commercial setting. If that happens, then only the first infusion will be recognized. If the second is not administered, that will not be recognized. So with that, I'm handing over to Rob to address the fixed cost question.

從我們的臨床經驗來看，這種情況極為罕見。事實上，我們在商業環境中很少見到這種情況。如果發生這種情況，那麼只有第一次輸液會被辨識。如果第二次沒有實施，那就不會被承認。因此，我將把解決固定成本問題的任務交給 Rob。

Yeah. Matt, so on the gross margin front, certainly, we saw, as you looked quarter-to-quarter from Q4 even last year where we had to recognize some idle capacity costs and then into Q1 and Q2, certainly trending the right way in terms of that number getting closer to breakeven. It's really a volume story for this year. And so what we've been very focused on is making sure the product is available, and we want to really make sure there's no limitations to the launch.

是的。馬特，在毛利率方面，當然，我們看到，從去年第四季度開始逐季度來看，我們不得不承認一些閒置產能成本，然後進入第一季度和第二季度，就該數字接近盈虧平衡而言，趨勢肯定是正確的。這確實是今年的一大新聞。因此，我們一直非常關注的是確保產品的可用性，並且我們希望確保產品的發布沒有任何限制。

We do expect as certainly the second half of the year will play out, and we continue to see volume increases that, that will continue moving in the right direction. No specific timing in terms of guidance and kind of when something will flip, but we certainly expect in the second half to continue in that direction.

我們確實預計下半年將會順利進行，並且我們將繼續看到交易量的成長，這將繼續朝著正確的方向發展。沒有具體的指導時間以及何時會發生轉變，但我們確實預計下半年將繼續朝著這個方向發展。

Gil Blum, Needham & Company.

吉爾布魯姆，Needham & Company。

Congrats on a strong quarter. Maybe a quick question here as it relates to kind of how is the product being received by the community in the US. Do you have some anecdotal feedback and maybe already some level of reorders? And I have a follow-up.

恭喜本季業績強勁。這裡可能有一個簡單的問題，即該產品在美國社區的接受程度如何。您是否有一些軼事回饋，或者可能已經有一定程度的重新訂購？我還有一個後續問題。

Well, thanks a lot for joining, Gil. The reception has been very, very positive. What we're seeing is and what we have pointed out in the past is obviously that the safety profile and the manageability was really something that was immediately experienceable, and that's been incredibly helpful. And we believe it's one of the key reasons also why we had early -- very early on we started to see actually reorders at the centers for the product. And that actually is developing very nicely across the centers that are active -- commercially active at this point.

好吧，非常感謝你的加入，吉爾。反響非常非常正面。我們所看到的以及我們過去指出的顯然是，安全性和可管理性確實是可以立即體驗到的，而且非常有幫助。我們相信這也是我們很早就開始看到產品中心重新訂購的主要原因之一。事實上，目前各個商業活躍的中心都發展得非常好。

So this looks very positive, and I think has a very nice reinforcing impact. And I think it's in line with, frankly, our prior experience. What we now see, obviously, as we go to the middle of the year, is that we start -- obviously, the physicians start to see the outcome, not just the immediate manageability of the product, but also the outcome in their patients. And we think that's going to be sort of a second push as we go into the second part of the year. And certainly, the FELIX data that we update, that we presented at EHA strongly, I think, point in that direction with the long-term plateau that we're seeing in the data and the survival data and obviously, a lot of the patients not requiring additional therapy, which is obviously resonating very well.

所以這看起來非常積極，而且我認為具有非常好的強化作用。坦白說，我認為這與我們之前的經驗一致。顯然，現在到了年中，我們開始看到——顯然，醫生開始看到結果，不僅是產品的直接可管理性，還有病人的結果。我們認為，這將是我們進入今年下半年的第二次推動。當然，我認為，我們在 EHA 上更新的 FELIX 數據強烈地指向了這一方向，我們在數據和生存數據中看到了長期平台期，顯然，許多患者不需要額外的治療，這顯然引起了很好的共鳴。

So we're really pleased with what we're seeing, the dynamic, and the feedback we're getting from the product, the experience, but also the experience, obviously, that the centers have with our commercial team and the reliability on the supply side, on the production side, which I think are really important to sort of actually have a -- be a real partner, frankly, for these physicians and patients in this space.

因此，我們對所看到的、從產品中獲得的動態和反饋感到非常滿意，當然，還有中心與我們的商業團隊的合作經驗以及供應方和生產方的可靠性，我認為這些對於成為這個領域的醫生和患者的真正合作夥伴非常重要。

Thank you for that. And can you provide any additional color regarding your negotiations with NICE?

謝謝你。您能否提供有關與 NICE 談判的更多詳細資訊？

So the process is obviously a very regulated process where there's obviously a query for quite a substantial amount of information and health economic assessments that we sort of provide and provide the data behind that. And then, it is a process that actually involves to quite an extent the -- treating physicians with experience with the product and experience with the indication, but also the patients themselves, which do actually have a voice in this process.

因此，這個過程顯然是一個受到嚴格監管的過程，其中顯然需要查詢大量資訊和健康經濟評估，我們會提供這些資訊和評估背後的數據。然後，這個過程實際上在很大程度上涉及到有產品經驗和適應症經驗的主治醫生，以及病人本身，他們在這個過程中確實有發言權。

So there is a dynamic there, where there's -- the company provides information, but we're actually not actively negotiating in that process in that particular interaction with NICE. But it's a process that's actually within that body, with obviously information requested from us, but then also support from the physician and patient community. And so this is ongoing.

因此，這其中存在一種動態，即——公司提供訊息，但在與 NICE 的特定互動過程中，我們實際上並沒有積極地進行談判。但這實際上是該機構內部的一個過程，顯然需要我們提供資訊，但同時也需要醫生和患者社群的支持。這一切仍在繼續。

We went through a first step. There is a second step now that we're running through. And we'll need to see where we get to, and then there's additional different paths that you can take from there on forward. So we're in the midst of this. So this is also a time point where it's very difficult to sort of give a view on where it may go, and we'll need to see kind of how it develops.

我們踏出了第一步。現在我們正在進行第二步。我們需要看看我們能到達哪裡，然後從那裡開始還有其他不同的路徑可以走。所以我們正處於這個階段。因此，這也是一個很難預測其走向的時間點，我們需要觀察其如何發展。

But overall, very strong support from the physicians and the patients for the product, which is obviously consistent with the experience that we had with obe-cel or AUCATZYL in the UK. And obviously, many of the patients that we have treated in our clinical trials were UK patients. So there is a strong amount of experience, also firsthand experience available, which we believe is helpful.

但總體而言，醫生和患者對該產品的支持非常強烈，這顯然與我們在英國使用 obe-cel 或 AUCATZYL 的體驗一致。顯然，我們在臨床試驗中治療的許多患者都是英國患者。因此，我們擁有豐富的經驗和第一手經驗，我們相信這是有幫助的。

Thank you for taking our questions.

感謝您回答我們的問題。

Asthika Goonewardene, Truist.

Asthika Goonewardene，Truist。

I'll echo my congrats on the strong AUCATZYL launch here that's panning out. A couple of quick financial questions and operational questions, and I got something more bigger picture. So start with, you've added about a dozen or so ATCs since your Q1 earnings. Can you maybe just walk us through the plan for bringing on more centers by year-end? And is there sort of like a training period as you bring on a new center that would make us kind of think about how productive these centers are as they come on?

我要再次祝賀 AUCATZYL 的強勢推出，並取得圓滿成功。透過幾個簡單的財務問題和營運問題，我得到了更全面的了解。首先，自從第一季獲利以來，您已經增加了大約十個 ATC。您能否向我們介紹年底前引進更多中心的計畫？當您引進新中鋒時，是否會有一個類似訓練期，讓我們思考這些中鋒上任後的效率如何？

And then the other quick financial question is, can you quantify the impact of out-of-spec products in your COGS?

然後另一個快速的財務問題是，您能量化不合格產品對您的 COGS 的影響嗎？

Okay. I'll take the ATC question first and then hand off to Rob on the OS question. So we did add -- obviously, you're correct, we added about 12 ATCs that are active. And we're going to continue, obviously, to add to the end of the year. We expect to be at 60 plus by the end of the year.

好的。我將首先回答 ATC 問題，然後將 OS 問題交給 Rob。所以我們確實增加了——顯然，你是對的，我們增加了大約 12 個活躍的 ATC。顯然，我們將繼續增加產量直到年底。我們預計到今年底將達到 60 歲以上。

So that progresses very nicely. When we look at the centers, obviously, the way that we have weighted the centers was to really look at those centers that have larger patient flows and often actually already have experience very early on and then kept adding to that. So you start actually with what do you think the centers are that will have a relatively high patient flow, and then gradually actually fill out the network of centers to make sure that patients have a good reach and also wouldn't have too much of a distance to access the therapy. And that's kind of what we're in.

所以進展非常順利。當我們考察這些中心時，顯然，我們對這些中心進行加權的方式是真正關注那些擁有較大患者流量並且通常實際上很早就已經擁有經驗並且不斷增加經驗的中心。因此，您實際上首先要考慮哪些中心的患者流量相對較高，然後逐步充實中心網絡，以確保患者能夠輕鬆到達，並且不會因為距離太遠而無法接受治療。這就是我們所處的境況。

So at this point in time, we keep on expanding into geographies that we haven't been present in, which we believe is important to make sure we're serving the breadth of the US very well. And we're making good progress on that. And with that also, I think we have an ability to make sure that the therapy actually becomes truly accessible for the vast majority of patients in the US.

因此，目前，我們繼續向我們尚未涉足的地區擴張，我們認為這對於確保我們能夠很好地服務美國各地非常重要。我們在這方面取得了良好的進展。並且，我認為我們有能力確保美國絕大多數患者能夠真正接受這種治療。

So this is -- when you look at the -- you can look at the ATC locator and you see we have a very significant amount of centers basically almost in a U-shaped form, from Chicago all the way up through the Midwest down to the South and back up again to -- way up to the West. And there's clearly additional centers that we're opening up in between to make sure that we actually have a very good distribution there.

所以這是——當你查看——你可以查看 ATC 定位器，你會發現我們有非常多的中心，基本上呈 U 形，從芝加哥一直向上穿過中西部到南部，然後再回到——一直到西部。顯然，我們正在開設額外的中心，以確保我們在那裡擁有非常好的分銷能力。

So that's sort of the way we look at that. And really a clear focus is to make sure that there is access in a reasonable distance. And with that, I think having an attractive network of clinics available for the patients to access. So with that, I think, Rob, just a follow-up on the OS question and potential impact overall.

這就是我們看待這個問題的方式。真正明確的重點是確保在合理的距離內可以進行訪問。有了它，我認為就可以建立一個有吸引力的診所網絡供患者使用。因此，我認為，Rob，只是跟進作業系統問題和整體潛在影響。

Yeah, sure. Thanks, Asthika, for the question. So let me first comment, when you think about out-of-spec and kind of financially where things land, there's actually two places where this can go. And so it's important to understand what drives that. So in certain situations, we do have an out-of-spec protocol that the site can choose to put the patient on to. And if the patient does receive the dose, even though it's out-of-spec under that out-of-spec protocol, it actually lands in our R&D expense.

是的，當然。謝謝 Asthika 提出的問題。因此，首先讓我評論一下，當你考慮超出規格和財務狀況的情況時，實際上有兩個可能的情況。因此，了解其驅動因素非常重要。因此，在某些情況下，我們確實有一個超出規格的協議，網站可以選擇讓患者遵守協議。如果患者確實接受了該劑量，即使該劑量不符合該超出規格的方案，它實際上也計入我們的研發費用。

What lands in cost of sales is out-of-spec product that is not administered under that protocol effectively like a scrap charge that goes through our cost of sales. So it's very hard to predict where patients will land in those two buckets, but it's fair to say that our experience to date overall in terms of our out-of-spec rates have been very in line with the FELIX study. And we said in the past that that's going to land somewhere between a 5% to 10% kind of range in terms of the experience and to date what we've seen in the commercial launch.

計入銷售成本的是不符合規格的產品，這些產品未依照該協議進行有效管理，例如計入我們銷售成本的廢品費用。因此，很難預測患者會落入這兩類情況中的哪一種，但可以公平地說，就我們的超標率而言，迄今為止我們的整體經驗與 FELIX 研究非常一致。我們過去曾說過，根據經驗以及迄今為止我們在商業發布中看到的情況，這一比例將在 5% 到 10% 之間。

Great. Thanks guys. And then just a bigger picture question on Europe here, on the European rollout. If you decide to launch in a specific country, let's say, in the UK, would you expect patients to travel from neighboring countries to receive therapy? Have you seen this happen with other CAR-T launches in Europe? And maybe if you can talk a little bit about the profile of AUCATZYL that might permit this to take place?

偉大的。謝謝大家。然後是關於歐洲的一個更大的問題，關於歐洲的推廣。如果您決定在特定國家/地區（例如英國）推出產品，您是否會期望患者從鄰國趕來接受治療？您在歐洲其他 CAR-T 產品上市時見過這種情況嗎？也許您可以稍微談談 AUCATZYL 的概況，以便實現這一點？

It's a really good question and something we've been looking into. So first of all, what we're seeing from a UK perspective is that there is a certain amount of medical tourism towards the UK for patients to get access. Typically, that medical tourism is coming from outside the EU to the UK, but there is a level of that.

這是一個非常好的問題，我們一直在研究這個問題。首先，從英國的角度來看，我們看到有一定數量的患者前往英國接受醫療旅遊。通常，醫療旅遊來自歐盟以外的國家，但也有一定程度的。

When we look within the EU, what we do see is that there is cross-border treatments that we certainly would see in a lot of the, particularly the border regions, where the infrastructure may not be evenly distributed across the border. Some of you know that I'm a Swiss national. I grew up close to Basel, which is very close to, I would say, Germany and France, literally bordering on both countries. And it's quite typical that if there are complex cases, children with complex issues or adults with complex issues that they might actually be coming from the surrounding areas within Germany or France into the university hospital in Basel across the border to be treated there. And there are also movements the other way if the specialty actually is on the other side of the border.

當我們觀察歐盟內部時，我們確實看到，在許多地方，特別是邊境地區，存在著跨境待遇，這些地區的基礎設施可能不是均勻分佈在邊境的。你們有些人知道我是瑞士人。我在巴塞爾附近長大，那裡離德國和法國都很近，實際上與這兩個國家接壤。很典型的是，如果出現複雜的病例，兒童有複雜的問題，或者成人有複雜的問題，他們可能會從德國或法國的周邊地區跨越邊境來到巴塞爾的大學醫院接受治療。如果特產實際上位於邊境的另一側，那麼也會有其他方式的流動。

So that actually does happen. And it is probably at this point difficult to quantify, but it clearly is not unusual to actually see that. To what extent that would be applicable for patients with acute leukemia, I do not know. But what we do know, and this is my old experience developing Blincyto, we had patients from very -- quite a wide range of countries and certainly during clinical trials to access trials in Germany and looking for treatment in Germany. And we also see that on the -- there is also some of that on the commercial side as well.

這確實發生了。目前可能很難量化，但實際上看到這種情況顯然並不罕見。我不知道這對急性白血病患者有多大程度的適用性。但我們確實知道，這是我開發 Blincyto 的舊經驗，我們有來自非常廣泛國家的患者，當然在臨床試驗期間，我們會在德國參加試驗並尋求在德國的治療。我們也看到，商業方面也存在一些這樣的情況。

So it is very much -- I think it's a possibility. And I think it's an area we're looking more into. Obviously, this has a lot to do with the nature of the insurance and the payer setup and obviously getting clearance from the payers, which typically for, certainly emergencies, that's clearly happening. And we're looking into what extent and what breadth this would be applicable here as well. But it is not unusual to see complex therapies to be accessed across the border.

所以我認為這是很有可能的。我認為這是我們正在深入研究的領域。顯然，這與保險的性質和付款人的設置有很大關係，顯然需要付款人的批准，這通常對於緊急情況來說顯然是會發生的。我們正在研究這在多大程度上和多大廣度上也適用於此。但跨境取得複雜療法的情況並不罕見。

Thanks, guys.

謝謝大家。

Kelly Shi, Jefferies.

Kelly Shi，傑富瑞集團。

Congrats on the progress. As you're now expanded to 46 treatment centers across the US, curious if you could share learnings (inaudible) the early adopters and also with reordering comes from also the high-volume centers of Tecartus or you actually see a different pattern? And also, for Germany and the UK, when could we anticipate the first revenue recording? And also have a follow-up. Thanks.

恭喜你取得進展。現在，您的治療中心已擴展到全美 46 個，您是否可以分享早期採用者的經驗（聽不清楚）以及來自 Tecartus 大容量中心的重新訂購，或者您實際上看到了不同的模式？另外，對於德國和英國，我們什麼時候可以預期首次收入紀錄？並且還有後續行動。謝謝。

Okay. Very good. Thanks for joining, Kelly. You're right, it's very interesting when we look at our centers in the US and we look at the use pattern across the centers, we have a range of centers that have quite exceeded our expectations in terms of the patients that they treated. And part of that expectation on our side was actually prior knowledge of the level of use of CAR-T in this indication in the past. And clearly, that looks changed in a good number of centers. So that's been very encouraging.

好的。非常好。謝謝你的加入，凱利。你說得對，當我們觀察美國的醫療中心並觀察這些中心的使用模式時，我們發現許多中心在治療患者方面已經遠遠超出了我們的預期。而我們這邊的這種期望部分其實是對過去 CAR-T 在此適應症中的使用水準的預先了解。顯然，許多中心的情況都改變了。這非常令人鼓舞。

We're also seeing centers where there is -- there are multiple physicians actually administering the product, which is another key metric that we're looking at. So not only have one physician at a center prescribed, but actually getting the use of the product more broadly distributed across all of the prescribing physicians for this indication.

我們也看到有多位醫生實際管理該產品的中心，這是我們正在關注的另一個關鍵指標。因此，不僅需要中心的一名醫生開立處方，而且實際上可以讓針對此適應症的所有開立處方的醫生更廣泛地使用該產品。

That's a dynamic we're following very carefully. And I think it's one of the key areas that we're going to be focusing on for our centers. It's important to understand that most of the patients are, in fact, being -- or expect that most of the patients with the relapsed, refractory disease are going to be treated at those, give or take, 60 centers that we're targeting now. And that gives you clearly a very -- a significant opportunity to focus from a commercial perspective and really build on the relationships, the connections, the experience at the center to actually keep expanding the use so that we are sort of getting to a place where the patients that are eligible for the therapy and can benefit from the therapy actually get access to it. So the dynamic I think we're seeing is very remarkable.

我們正在密切關注這一動態。我認為這是我們中心將重點關注的重點領域之一。重要的是要明白，事實上大多數患者——或者預計大多數患有復發性、難治性疾病的患者將在我們現在瞄準的 60 個中心接受治療。這顯然為你提供了一個非常重要的機會，從商業角度來關注，並真正建立關係、聯繫和中心經驗，以不斷擴大使用範圍，以便我們能夠讓符合治療條件並能從治療中受益的患者真正獲得治療。所以我認為我們所看到的動態非常引人注目。

Repeat use is one of the key things we're looking at. We're seeing a very nice adoption of repeat use across all our centers. And we're really monitoring that very carefully and supporting that process. So this has been very, I think, very interesting and the high-volume centers have been phenomenal to see kind of the level of engagement and patient flow that resulted from that. And we're clearly building on that, and we're going to go to take the learnings from those centers also into the other centers.

重複使用是我們正在關注的關鍵事項之一。我們看到所有中心都出現了非常好的重複使用現象。我們確實在非常仔細地監控並支持這一進程。所以我認為這非常有趣，大容量中心的參與度和患者流量水平令人驚嘆。我們顯然正在以此為基礎，並將把這些中心的經驗帶到其他中心。

And then with regards to the UK and Germany, obviously, those are two different processes from a patient access perspective. We're in the midst of the current process in the UK. And I hope that over the next few months, we can actually get to a resolution there. And then actually, if positive, we would expect to be able to launch in the probably early part end of this year, early part of next year. But it is contingent on obviously getting a reasonable outcome that is economically viable for us. And so that's kind of what we're working towards.

至於英國和德國，顯然，從病人就醫的角度來看，這是兩個不同的流程。我們正處於英國當前的進程之中。我希望在接下來的幾個月裡，我們能夠真正達成解決方案。實際上，如果結果為肯定的話，我們預計可能能夠在今年年底或明年年初推出。但這顯然取決於能否獲得對我們來說經濟上可行的合理結果。這就是我們努力的目標。

And in Germany, we certainly want to sort of have more engagement on the physician, the patient side, but also with the respective regulatory bodies in Germany. And at the same time, we're looking for more data to also become available over time from the experience, the real-world experience in the US, which we hope would also actually be supportive for these conversations. So at this point, we're not guiding to sales in Germany because it ultimately is dependent on where we're going to end up in those negotiations.

在德國，我們當然希望與醫生、病人以及德國的相關監管機構有更多的接觸。同時，我們也在尋求隨著時間的推移從經驗、美國現實世界的經驗中獲得更多的數據，我們希望這些數據實際上也能支持這些對話。因此，目前我們不會指導德國的銷售情況，因為這最終取決於我們在談判中的結果。

But we're also looking at other European countries, and we may change the order of access within Europe based on where we are and what we know at this point.

但我們也在關注其他歐洲國家，我們可能會根據目前的狀況和了解的情況改變歐洲境內的准入順序。

Super helpful. Thanks so much. And also for autoimmune, curious for the ACR presentation in Q4, what other data points could be included beyond what has been presented in the past? And also, could you share some additional color maybe, do you have other ongoing [translational] studies, maybe to tell us more on like the B-cell dynamic or maybe some of the correlation to patient baseline characteristics to guide future development in autoimmune space? Thank you.

超有幫助。非常感謝。對於自體免疫，我很好奇第四季的 ACR 演示，除了過去呈現的內容之外，還可以包括哪些其他數據點？另外，您能否分享一些額外的信息，您是否還有其他正在進行的 [轉化] 研究，也許可以告訴我們更多關於 B 細胞動態或與患者基線特徵的一些相關性，以指導自身免疫領域的未來發展？謝謝。

Yeah, very good questions. Thanks, Kelly. So on the -- with regards to the data at ACR, obviously, the key update will be related to the longer follow-up of the six patients that we had reported on at the R&D event earlier in Q2. And I think that will give us a good idea of kind of how the product overall actually is performing because we're going to have six plus months of follow-up with all the patients. So I think that will be, I think, probably the key part of the follow-up.

是的，非常好的問題。謝謝，凱利。因此，就 ACR 的數據而言，顯然，關鍵的更新將與我們在第二季早些時候的研發活動中報告的六名患者的長期追蹤有關。我認為這將讓我們很好地了解產品的整體表現，因為我們將對所有患者進行六個月以上的追蹤。所以我認為這可能是後續行動的關鍵部分。

We actually did enroll more patients on the study. So there's also going to be earlier data from those patients that will be included. And I think that's obviously one of the key areas. We've been looking very carefully at a lot of different parameters for these patients to develop a good understanding of the pharmacodynamics both of the product, but also and how we're impacting potential disease stations, et cetera. So those are data sets that we're also pulling together and we're going to be looking at. We're looking at a range of -- obviously, I've been evaluating a range of indications.

我們確實招募了更多的患者參與這項研究。因此，還將包括這些患者的早期數據。我認為這顯然是關鍵領域之一。我們一直在非常仔細地研究這些患者的許多不同參數，以便更好地了解產品的藥效動力學以及我們如何影響潛在的疾病站等等。這些也是我們正在匯總並要查看的資料集。我們正在研究一系列——顯然，我一直在評估一系列跡象。

Obviously, the first one that we sort of decided to move on is lupus nephritis. That's clearly where we're going to double down on. And I mentioned the fact that we're -- obviously, we're opening that study, and we're making really good progress there and expect to have patients treated still this year. And that gives us -- I think, will give us a very nice momentum in that study, also considering it's a very compact study, will give us a shot to also, frankly, be first-in-class in that indication. And then secondly, we're obviously very interested in seeing the performance of the product in the progressive MS patients.

顯然，我們決定先著手治療的是狼瘡性腎炎。這顯然是我們要加倍努力的地方。我提到，顯然，我們正在進行這項研究，並且取得了非常好的進展，預計今年仍將有患者接受治療。我認為，這將為我們在該研究中帶來非常好的勢頭，同時考慮到這是一項非常緊湊的研究，坦率地說，這將使我們有機會在該適應症中成為一流的。其次，我們顯然非常有興趣看到該產品在進展型多發性硬化症患者中的表現。

And there's going to be also a lot of analysis that will be done in those patients, translational type of analysis, to understand the impact of the mechanism of action, et cetera, in addition to obviously the actual clinical readouts and the imaging readouts that we're going to be taking from those patients. So there's quite a lot going on there, and there's also obviously additional work that we're doing to look into additional indication options. But obviously, for now, very much focused on the indications I just went through. Thank you.

除了我們將從這些患者身上獲得的實際臨床讀數和影像讀數之外，我們還會對這些患者進行大量的分析，轉換類型的分析，以了解作用機制的影響等等。所以那裡有很多事情要做，而且顯然我們還在做額外的工作來研究額外的指示選項。但顯然，目前，我非常關注我剛剛經歷的跡象。謝謝。

Simon Baker, Rothschild & Company Redburn.

西蒙貝克 (Simon Baker)，羅斯柴爾德公司雷德伯恩分公司。

Two, if I may, please. Firstly, Christian, just going back to the European launch outlook. Shall we say, traditional drug launches, there's a fairly established routine of go in Germany first because you can set your price and then it gets adjusted and then work your way through the countries ultimately receiving towards the end reimbursement in France. Clearly, that's not the same in cell therapy. So I wonder if you could just highlight any areas where there is a markedly different process of seeking reimbursement, which affects the order of countries in which you will seek to launch?

如果可以的話，請給我兩張。首先，克里斯蒂安，我們來回顧歐洲的發布前景。我們可以說，傳統的藥品上市，有一個相當成熟的流程，首先在德國進行，因為你可以設定價格，然後進行調整，然後逐步推廣到其他國家，最終在法國獲得報銷。顯然，細胞療法的情況有所不同。所以我想知道您是否可以強調在哪些領域尋求報銷的流程明顯不同，這會影響您尋求啟動的國家順序？

And then secondly, going back to the UK, at the same time that NICE was saying no to capsule, the MHRA introduced the world's first framework for point-of-care manufacture of cell therapies, including CAR-T. I just wanted to get your perspectives on the pertinence of that to Autolus and if any other regulators in the world are looking at similar approaches. Thanks so much.

其次，回到英國，在 NICE 拒絕膠囊的同時，MHRA 推出了世界上第一個細胞療法（包括 CAR-T）的即時診斷製造框架。我只是想了解您對此事與 Autolus 的相關性的看法，以及世界上是否有其他監管機構正在考慮類似的方法。非常感謝。

Yeah, good question. So the first one is around kind of sequence of launch in Europe. You're correct. For many of more traditional therapies, the sequence of launch tends to be Germany -- the least traditionally it's Germany, and then you kind of walk through kind of a series of countries to sort of ultimately get the majority of them. That started to actually change somewhat.

是的，好問題。因此，第一個是關於歐洲的發布順序。你是對的。對於許多更傳統的療法來說，推出的順序往往是德國——最不傳統的是德國，然後你需要經過一系列國家，最終獲得大多數療法。情況確實開始有所改變。

Obviously, Germany is still the single biggest market. But in terms of market access, not necessarily the most attractive country in Europe. So I think that's -- and we're talking sort of pre-the-current administration. That's certainly been true.

顯然，德國仍然是最大的單一市場。但就市場進入而言，不一定是歐洲最具吸引力的國家。所以我認為這是——我們正在談論現任政府之前的情況。這確實是事實。

When we look at the current administration, I think there are a few things to keep in mind. First of all, the most favorite nation process, obviously, is one that actually reference prices in various territories. Now, there are two types of prices that tend to be quoted. One is a list price, the other one is discounted price. Now, different countries actually deal with that in different ways. Some countries publish list prices, but not negotiated prices. Some countries publish negotiated prices.

當我們審視現任政府時，我認為有幾件事需要牢記。首先，最受歡迎的國家流程顯然是實際上參考各個地區價格的流程。現在，有兩種類型的價格往往會被引用。一個是標價，一個是折扣價。現在，不同的國家實際上以不同的方式處理這個問題。有些國家公佈的是標價，但不公佈協商價格。一些國家公佈協商價格。

And you can imagine in the current environment where there's a lot of uncertainty around what processes are, frankly, what are the rules, what's going to be applicable and so on and so forth, that creates, I think, a lot of questions for, frankly, all pharmaceutical companies looking at launching in Europe because depending on where you are, what you agree to, et cetera, you may actually have a discrepancy to the US price, at which point you might actually be having an exposure that may or may not be reasonable to take.

你可以想像在當前的環境下，對於流程、規則、適用條件等存在很多不確定性，坦白說，這給所有考慮在歐洲推出產品的製藥公司帶來了很多問題，因為根據你所在的位置、你同意的內容等，你的價格實際上可能與美國價格存在差異，此時你可能會面臨可能合理也可能不合理的風險。

So that's one generally across the board, I think something that I think every pharmaceutical company needs to look at, needs to think about because it's a very significant level of uncertainty and very unclear set of rules that ultimately may apply or may not apply. So that's sort of one area to look at.

所以，我認為這是一個普遍的問題，每個製藥公司都需要關注、需要思考，因為這是一個非常大的不確定性和非常不明確的規則，最終可能適用也可能不適用。這是一個值得關注的領域。

The second part is that -- and this has been one of the real challenges in the cell and gene therapy space, is that the methodology to actually calculate the prices and sort of provide market access at, has been designed for very different type of products and very different types of clinical data. So when you look at the cell and gene therapy space, most of the indications we're developing in, we're developing in very high medical need settings in smaller indications, and we're going for very high treatment effects.

第二部分是——這是細胞和基因治療領域面臨的真正挑戰之一，即實際計算價格和提供市場准入的方法是針對不同類型的產品和不同類型的臨床數據而設計的。因此，當您觀察細胞和基因治療領域時，我們會發現，我們正在開發的大多數適應症都是在醫療需求非常高的環境下針對較小的適應症進行的開發，並且我們追求的是極高的治療效果。

The reason what that does is it allows us to actually develop -- and which is what all regulators agree with -- to develop with single-arm clinical trials for approval and demonstrating very clear-cut clinical benefit and risk-benefit profile in those indications. And we see that across the board. There's a huge disconnect between the view that we have with the regulators and the methodology that we're seeing for market access, which are all based on classical randomized controlled studies, that then also assume we can do a direct comparison to a similar product.

這樣做的原因是，它使我們能夠真正地進行開發——這也是所有監管機構都同意的——通過單臂臨床試驗來獲得批准，並展示出在這些適應症中非常明確的臨床益處和風險收益概況。我們普遍看到了這一點。我們對監管機構的看法和我們所看到的市場准入方法之間存在巨大差異，這些方法都是基於經典的隨機對照研究，也假設我們可以與類似產品進行直接比較。

And quite often -- and so that's typically then obviously difficult. You haven't seen CAR-T therapies that are being compared in a single trial. And we're not going to see that going forward. That's not actually doable. So what's then happening is your next best thing is you got to compare against some form of standard of care, which varies widely of what that actually is considered to be.

而且經常如此——因此這通常顯然很困難。您還沒有看到在單次試驗中進行比較的 CAR-T 療法。而我們不會再看到這種情況發生。這實際上是不可行的。那麼接下來最好的事情就是與某種形式的護理標準進行比較，這與實際的護理標準有很大差異。

And then in the absence of a actual direct comparison and randomized controlled data to your product creates the situation that the model doesn't actually allow you to quantify because the model doesn't -- can't handle the data. And so as a consequence, you get a benefit which is acknowledged, but it cannot be quantified. And hence, it's called a non-quantifiable benefit, which is oxymoron in English. It kind of works in German where some of those concepts came from. So the problem that, that creates is a very significant disconnect that actually the system is not set up to value that.

然後，由於缺乏對您的產品進行實際直接比較和隨機控制數據的情況，模型實際上不允許您量化，因為模型無法處理數據。因此，你會獲得公認的利益，但無法量化。因此，它被稱為不可量化的利益，這在英語中是矛盾的。它在德語中是可行的，其中一些概念來自德語。因此，由此產生的問題是嚴重的脫節，實際上系統並沒有重視這一點。

And on top of that, you have not in the UK, but for most of Europe, a disconnect between how healthcare actually and healthcare costs are looked at. You have obviously a very significant component that are infrastructure related. These are your hospitals, your staffing, your basic operation, et cetera, which is a huge chunk of the cost in any healthcare system. Well, in most European countries, that is covered by taxes. And it's opaque, not actually -- not transparent, not visible to the public what that actually costs.

除此之外，不僅在英國，歐洲大部分地區對醫療保健的實際情況和醫療成本的看法也存在脫節。顯然，您有一個與基礎設施相關的非常重要的元件。這些是您的醫院、您的人員、您的基本營運等等，它們在任何醫療保健系統中都是很大一部分成本。嗯，在大多數歐洲國家，這部分費用都由稅收負擔。而且它是不透明的，實際上並不透明，公眾無法看到它的實際成本。

What then actually is sort of going into the assessment is, in essence, what's left over. And that's mostly the therapeutic cost and the diagnostic cost and some very specific procedures. And that's actually what's carried by the payers. That disconnect is very, very significant and creates a problem because then if you want to have a full value assessment, you cannot actually properly do that because obviously, a big chunk, as an example, of a one-off therapy that gives you a curative outcome, as a hypothetical example, that has a huge impact on your infrastructure bit and not using -- not actually utilizing that infrastructure. That's not covered. That's not part of the model.

那麼，實際上進入評估的是本質上剩下的東西。這主要是治療費用、診斷費用和一些非常特定的程序。這實際上就是付款人所承擔的。這種脫節非常非常嚴重，並且會產生問題，因為如果您想進行全面的價值評估，您實際上無法正確地做到這一點，因為顯然，舉個例子，一次性治療的很大一部分可以給您帶來治愈結果，作為一個假設的例子，這會對您的基礎設施產生巨大影響，並且不會使用 - 實際上不會利用該基礎設施。這不包括在內。這不是模型的一部分。

And hence, we do have a huge disconnect in the view of value. And that's where the fundamental disconnect is in the various systems. And that is sort of why there is -- this is more of an actual process to go through and why it leads to kind of quite different types of outcomes and different assessments. So those are, I think, a few points there to consider, which are just very different -- significant differences in the underlying methodology and the way that, frankly, healthcare is being paid for.

因此，我們在價值觀上確實存在著巨大的差距。這就是各個系統之間根本脫節的地方。這就是為什麼這更像是一個實際的過程，也是為什麼它會導致不同類型的結果和不同的評估。所以，我認為，這些是需要考慮的幾個點，它們非常不同——在基本方法和坦率地說，醫療保健支付方式方面存在顯著差異。

Great. Thank you.

偉大的。謝謝。

Yanan Zhu, Wells Fargo.

朱亞南，富國銀行。

This is Jeff on for Yanan. For the AUCATZYL launch in the US, can you provide any detail on how many patients were treated in the second quarter and year to date? And then second question on the longer-term SLE readout at ACR in late October. It was mentioned that additional patients have been enrolled beyond the initial six. How many patients do you anticipate including in the readout? I believe there were a total of 12 to be dosed in Phase 1. Have all 12 been treated? And were any of them adolescent? Thanks.

我是傑夫，代表延安。對於 AUCATZYL 在美國的推出，您能否提供第二季和今年迄今為止治療了多少患者的詳細資訊？第二個問題是關於 10 月下旬 ACR 的長期 SLE 讀數。據稱，除了最初的六名患者外，還招募了更多患者。您預計讀數中會包含多少名患者？我相信第一階段總共有 12 人需要服藥。12 個人都接受治療了嗎？他們當中有人是青少年嗎？謝謝。

Yeah, very good question. So first of all, we have not guided on the number of patients, but you can actually backtrack the numbers, I think, reasonably well from knowing the cost of the therapy. But we haven't given a detailed number there, but I think you can get very close just by backtracking.

是的，非常好的問題。首先，我們還沒有確定患者人數，但我認為，透過了解治療費用，你實際上可以相當好地追溯這些數字。但我們並沒有給出詳細的數字，但我認為只要回溯一下就可以得到非常接近的數字。

The second is related to the number of SLE patients. We obviously continue to dose patients. We had a small cohort at an elevated dose level of 100 million cells, and we have expanded the trial to include three adolescent patients. We do not expect, given the timing of the data [cut] to actually have adolescent patients in the analysis. The focus will be on the adult patients, and we'll sort of give an up-to-date view on the experience with the 50 million and probably initial experience on 100 million.

第二與SLE患者數有關。我們顯然會繼續給患者服藥。我們有一個劑量水平高達 1 億個細胞的小群體，並且我們已將試驗範圍擴大到包括三名青少年患者。考慮到數據[截取]的時間，我們並不期望在分析中真正包含青少年患者。重點將放在成年患者身上，我們將對 5000 萬名患者的最新經驗以及可能 1 億患者的初步經驗提供最新看法。

Got it. Thank you very much.

知道了。非常感謝。

Max (inaudible), Goldman Sachs.

馬克斯（聽不清楚），高盛。

This is Max for Rajan Sharma. First one is, could you comment on what proportion of your centers are now operational and enrolling patients? And how should we think about the revenue momentum and trajectory? Is the growth between 1Q and 2Q a good run rate for the full year?

這是 Rajan Sharma 的 Max。首先，您能否評論一下目前有多少比例的中心正在運作並接收患者？我們該如何看待收入動能和軌跡？第一季和第二季之間的成長對於全年來說是一個良好的成長速度嗎？

And the second question is about the lupus Phase 2 trial. Could you talk us through when we could see data from this trial and what do you see as the bar for success? Thank you.

第二個問題是關於狼瘡第二階段試驗的。您能否告訴我們何時可以看到這次試驗的數據以及您認為成功的標準是什麼？謝謝。

Yeah. So thanks for joining, Max. So the momentum, obviously, we're seeing has been very positive first half of the year. As we indicated, we do see an impact from the resolution of the CMS decision on the pricing because it had an impact on the centers to sort of adjust their actual internal policy and procedures. And during that process, some of the centers were actually not enrolling patients or have to slow down enrollment of patients.

是的。感謝你的加入，Max。因此，顯然我們看到今年上半年的勢頭非常積極。正如我們所指出的，我們確實看到了 CMS 決議對定價的影響，因為它影響了中心調整其實際的內部政策和程序。在這個過程中，一些中心實際上並沒有招募患者，或者不得不放慢招募患者的速度。

So that has an impact because that obviously then (inaudible) goes through given the time it takes to manufacture, release and actually ultimately treat the patient. So we're expecting to have an impact in the current quarter. We expect to be outside of any impact related to the CMS decision in the fourth quarter.

這會產生影響，因為顯然（聽不清楚）需要經過製造、發布和最終治療患者所需的時間。因此我們預計本季將產生影響。我們預計第四季不會受到 CMS 決定的任何影響。

So that's kind of where we are. So we're kind of -- obviously have a very good first half. I think we had a very good second quarter, and we think we're going to actually overall have a very positive continuation in the second half of the year, but we're not going to, at this point, can give you sort of more guidance than that.

這就是我們現在的狀況。所以，我們顯然上半年表現非常好。我認為我們第二季度的表現非常好，而且我們認為下半年的整體表現將會非常積極，但目前我們無法給您更多指導。

With regards to the centers that are active, so out of the 46 centers you see on the access page, the vast majority of those patients actually have treated obviously, their patients. There's obviously some very new ones that are actually starting now to actually -- are now ready and are ready to actually receive patients. So those are in the process of actually getting their first patient, but the vast majority of the centers that you see on the ATC locator actually have been already treating patients and many of them actually have treated multiple patients.

關於活躍的中心，在訪問頁面上看到的 46 個中心中，絕大多數患者顯然已經接受了治療。顯然，有一些非常新的醫院實際上現在已經開始準備接收病人。因此，這些中心實際上正在接收第一位患者，但您在 ATC 定位器上看到的絕大多數中心實際上已經在治療患者，其中許多中心實際上已經治療了多名患者。

And then the question related to the lupus nephritis study and when to expect data, I think that is premature at this point in time. We have indicated, I think, the regulatory hurdle that the trial is basically designed to (inaudible). And as we discussed in the Q&A session at the R&D event, there's obviously a regulatory hurdle, but there was also an expectation that we're probably going to exceed or would like to set that level to be exceeded.

然後關於狼瘡性腎炎研究的問題以及何時可以獲得數據，我認為目前還為時過早。我認為，我們已經指出了這項試驗的監管障礙，基本上是為了（聽不清楚）。正如我們在研發活動的問答環節中所討論的那樣，顯然存在監管障礙，但我們也期望我們可能會超過或希望設定超過該水平。

But in terms of data, that is too early to tell. We're starting the study up. We haven't enrolled a single patient at this point. We expect to have enrolled patients by the end of the year. So this is premature to actually give guidance on the time line for enrollment and data. Thank you.

但就數據而言，現在下結論還為時過早。我們正在開始這項研究。目前我們還沒有招募任何一名患者。我們預計今年底就能招募到病患。因此，現在就招生和數據的時間表給出指導還為時過早。謝謝。

I'm not showing any further questions this time. I'd turn the call back to Christian for any further remarks.

這次我不會提出其他問題。我會把電話轉回給克里斯蒂安，讓他發表進一步的評論。

Well, first of all, thanks a lot for joining. Obviously, a great quarter. We're keeping you updated, obviously, as we go through the third quarter here. We're very pleased with the dynamic we're seeing and the reception of the product. We keep pushing, and we certainly keep pushing our clinical trials and are looking forward to sort of looking for ways to actually making the product available to a larger number of patients beyond adult ALL. And we'll obviously show first data in that regard towards the end of the year, both on the SLE side as well as the pediatric ALL side.

嗯，首先，非常感謝您的加入。顯然，這是一個偉大的季度。顯然，隨著我們進入第三季度，我們會隨時向您通報最新情況。我們對所看到的動態和產品的接受度感到非常高興。我們將繼續努力，我們當然將繼續推進我們的臨床試驗，並期待著找到方法，讓更多的成人 ALL 患者能夠真正享受到該產品的益處。我們顯然會在年底前展示這方面的第一批數據，包括 SLE 方面以及兒科 ALL 方面。

With that, I'd like to thank you for joining and wish you a great summer. Thank you.

最後，我要感謝您的加入，並祝福您有個愉快的夏天。謝謝。

Thank you, ladies and gentlemen. That's concludes today's presentation. You may now disconnect, and have a wonderful day.

謝謝各位，女士們、先生們。今天的演講到此結束。現在您可以斷開連接，享受美好的一天。