Autolus Therapeutics PLC (AUTL) 2026 Q1 法說會逐字稿

Good day, everyone, and welcome to Autolus Therapeutics first quarter 2026 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to turn the call over to the Executive Director of Investor Relations, Amanda Cray. Please go ahead.

各位好，歡迎參加 Autolus Therapeutics 2026 年第一季財務業績電話會議。（接線員指示）請注意，今天的會議將被錄音。現在我想把電話交給投資人關係執行董事 Amanda Cray。請開始。

Thank you, Carmen. Good morning or good afternoon, everyone, and thank you for joining us on today's call. With me are 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，Carmen。各位早安或午安，感謝各位參加今天的電話會議。與我一同出席的有執行長 Christian Itin 博士，以及財務長 Rob Dolski。我想提醒各位，在今天的電話會議中，我們將就本公司業務發表若干依據聯邦證券法及 1995 年《私人證券訴訟改革法》安全港條款所界定的前瞻性陳述。

These may include, but are not limited to, statements regarding status of the ongoing commercial launch of AUCATZYL in the US and UK; 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.

這些陳述可能包括但不限於：AUCATZYL 在美國與英國持續商業上市的進展狀況；Autolus 針對 AUCATZYL 的製造、銷售與行銷計畫；AUCATZYL 的市場潛力，以及 obe-cel 的臨床試驗狀態、開發及／或法規時程與市場機會。

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.

這些陳述受到多項風險與不確定性影響，可能導致實際結果與預期有重大差異，且僅反映我們截至今日的觀點。我們不承擔更新任何此類前瞻性陳述的義務。關於可能影響我們實際結果之重大風險與不確定性的討論，請參閱今日新聞稿及我們向 SEC 提交的文件中所識別的風險；兩者皆可於我們網站的投資人專區取得。

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.

在第 3 張投影片，您將看到今天電話會議的議程。如同以往，Christian 將概述我們的營運重點。接著 Rob 將說明財務結果，Christian 將以即將到來的里程碑與結語作結。我們之後將進行問答。

With that, I will turn it over to Christian.

接下來，我把時間交給 Christian。

Thanks, Amanda, and welcome, everyone, to our first quarter update. Moving to slide number 4. We had a very good first quarter, and we see nice traction building both in the US and obviously, in our early launch in the UK as well.

謝謝你，Amanda，也歡迎各位參加我們的第一季更新。請看第 4 張投影片。我們第一季表現非常好，無論在美國，或是在英國的早期上市，我們都看到良好的推進動能正在形成。

In Q1, we had $26.2 million in revenue booked, and we do see a very nice penetration and deepening with the positive physician experience that was highlighted at the Tandem meeting as part of the ROCCA Consortium presentation, where we had approximately 60% of our commercial patients represented in that data set, and we had discussed the data at the full year update, which is gave a few weeks ago and also was further analyzed and reviewed in the context of a KOL call we did in the early part of April.

第一季我們認列了 2,620 萬美元營收；我們也看到非常不錯的滲透率提升與深化，這得益於醫師端的正向使用經驗。這些經驗在 Tandem 會議上、作為 ROCCA 聯盟（Consortium）報告的一部分被重點呈現，其中約有 60% 的商業化患者納入該資料集。我們在幾週前的全年更新中已討論過這些資料，並且在 4 月上旬我們舉辦的 KOL 電話會議中，亦在其脈絡下進一步分析與檢視。

When we then look into the UK, we do see a very good start in the UK We have more than 10 centers already active. We're going very strong in the UK with regards to not only center onboarding, but also start to see early patients come in and actually become treated under the NHS access program.

再看英國方面，我們在英國的起步非常良好，已有超過 10 家中心啟動。我們在英國的推進力道很強，不僅在中心導入（onboarding）方面，同時也開始看到早期患者進入，並且實際在 NHS 可近用計畫下接受治療。

Now when we look into the 2026 overall outlook, we do see that we have a very nice continued momentum. We're currently from a perspective of US centers already at around 73 centers, and we're increasing beyond 80 centers by the end of the year. Our year-end guidance -- full year guidance is unchanged at $120 million to $135 million. And for the first time this quarter, we did see a shift to positive gross margin, which is important because, obviously, this is one of the key metrics that we're looking at during the course of this year to start to actually see that the overall commercial base and our ability to ultimately drive proper cash flow into the company increase over time.

就 2026 年整體展望而言，我們看到動能持續良好。目前以美國中心數來看，已約達 73 家，並將在年底前提升至超過 80 家。我們的全年指引維持不變，為 1.2 億至 1.35 億美元。此外，本季我們首次看到毛利率轉為正值，這很重要，因為這顯然是我們今年關注的關鍵指標之一，用以開始觀察整體商業基礎以及我們最終為公司帶來適當現金流的能力，如何隨時間提升。

So first time positive gross margin and obviously, a lot of that impacted by, on the one hand, an increase in volume, but also operational improvements that we made to the overall operation of the company, but in particular, the operation of the manufacturing plant that we're running. So this is where we are with regards to the overview from a commercial perspective for AUCATZYL. Very good dynamic, and we believe very strong momentum as we go into Q2.

因此，毛利率首次轉正；這一方面受到銷量增加的影響，另一方面也來自我們對公司整體營運所做的改善，尤其是我們所營運的製造廠之運作改善。以上即為 AUCATZYL 在商業面向的概覽：動態非常良好，我們相信在進入第二季時將延續非常強勁的動能。

So with that, we're going to slide number 5. I would like to start on the right-hand side and just briefly talk about the journey that we're on with regards to moving the product to a place where indeed we have a profitable ALL business. The foundation was really laid during the first year of launch. And what we had to establish during that first year of launch is consistent and high-quality product supply and services so that we have a strong foundation, we serve our patients properly, and we can generate very strong outcomes in these patients. And you've seen all of that actually presented as part of the ROCCA Consortium's experience, which had more than -- actually almost all patients that were intended to be treated actually receive treatment.

接著請看第 5 張投影片。我想先從右側開始，簡要談談我們在推動產品邁向「可獲利的 ALL 業務」這段旅程中的進展。這個基礎其實是在上市第一年奠定的。在上市第一年，我們必須建立的是一致且高品質的產品供應與服務，讓我們有堅實基礎、能妥善服務患者，並在這些患者身上產生非常好的治療結果。各位已在 ROCCA 聯盟的實務經驗中看到這些成果；其中原本預計要接受治療的患者，幾乎都實際接受了治療。

And we also did see that, that treatment actually translated into a very positive safety profile with no high-grade CRS, only 3% high-grade ICANS and more than 90% overall response rate in the patients. So a remarkable outcome in the hands of the physicians in the real-world setting. And we're also starting to see that we already start to see branching out of the patient pool into patients that actually are older, have more comorbidities, typically tend to be considered difficult to treat. That's one expansion that we've seen, but also an expansion into patients that have very limited tumor burden. And with that, obviously, what we have seen in our prior studies certainly have a good opportunity to sort of get a more pronounced benefit over time.

我們也看到治療帶來非常正向的安全性概況：沒有高等級 CRS，高等級 ICANS 僅 3%，且患者的整體反應率超過 90%。這是在真實世界情境下、由臨床醫師操作所取得的卓越結果。我們也開始看到患者族群的擴展：一方面擴展到年齡更大、共病更多、通常被視為較難治療的患者；另一方面也擴展到腫瘤負荷非常有限的患者。就此而言，根據我們先前研究所見，確實有機會隨時間推移獲得更明顯的效益。

So we've seen an expansion already in terms of the patient pools. That is very important because based on that behavior as well as the good safety profile, we do expect that, that forms a very strong foundation, and we see that translate actually already in the first few months in 2026.

因此，我們已看到患者族群在規模上的擴展。這非常重要，因為基於這樣的使用行為以及良好的安全性概況，我們預期這將形成非常強的基礎，而我們也在 2026 年的前幾個月就已看到其轉化成果。

The second stage now as soon as we actually have established consistent high-quality product supply and services, that is actually when we switched gears and really started to drive optimization, improve efficiency as well as at the same time, obviously increase the volumes that actually we're driving through the overall operation. And with that, have an ability to actually get our overall cost down for the products. We expect the peak -- at the peak ALL business to be around 65% to 70% gross profit margin, which gives us a very healthy business for the ALL side of our AUCATZYL.

第二階段是：一旦我們建立起一致且高品質的產品供應與服務，我們就會轉換檔位，真正開始推動最佳化、提升效率，同時也提高整體營運所能推動的產量。藉此，我們能夠降低產品的整體成本。我們預期在 ALL 業務達到高峰時，毛利率約為 65% 至 70%，這將使我們在 AUCATZYL 的 ALL 端擁有非常健康的業務。

Now the optimization we ran through, obviously, also was not just an optimization in processes, but also with that, obviously, we have run through a reduction in force at the company of 13%. And we also, at the same time, driven up the efficiency that we're running within the operation. And you'll see that in a very simple metric, we expect to produce twice as much product this year compared to last year with overall staffing that is at or below the levels that we had last year. So that gives us a very clear understanding of why indeed these gross margins are moving into the positive and will continue to improve as we go through the course of this year. Now overall, as once the one-time effect of the restructuring is taken care of, and you'll see that pass through, and Rob will talk to that briefly, we expect for 2027 a net impact of a savings of $15 million on an annualized basis.

我們所推動的最佳化，顯然不僅是流程上的最佳化；同時，我們也進行了公司 13% 的人力縮減。此外，我們也同步提升營運效率。用一個非常簡單的指標即可看出：我們預期今年的產量將是去年的兩倍，而整體人力配置將與去年持平或更低。這讓我們非常清楚理解，為何毛利率確實已轉為正值，並將在今年過程中持續改善。整體而言，一旦重組的一次性影響處理完畢（您將會看到其反映；Rob 也會簡要說明），我們預期 2027 年在年化基礎上，淨影響將節省 1,500 萬美元。

When we then look on to the development side and leveraging the exceptional profile that we now not only are seeing in clinical trials, but see it translated also in the real-world setting, we're obviously building on that set of properties into a range of additional indications. The first one clearly to extend the treatment from the adult population into the pediatric population. And we have the Phase II expansion of the CATULUS study ongoing. Data is expected towards the end of 2027, and we have aligned with the FDA on the protocol design and support for potential registration.

再看研發面向，基於我們目前不僅在臨床試驗中看到、也在真實世界情境中得到驗證的卓越特性，我們顯然正以這些特性為基礎，拓展至一系列額外適應症。第一個明確方向，是將治療從成人族群延伸至兒科族群。我們正在進行 CATULUS 研究的第二期擴展；預期資料將於 2027 年底前後取得，且我們已與 FDA 就試驗方案設計及潛在註冊所需支持達成一致。

The second study, obviously, that is progressing well. We expect actually data during -- additional data towards the end of this year is the CARLYSLE study, where we have added additional patients, and we're also -- obviously, we will have substantial more follow-up in that patient population. And I think that will give us a very good understanding of the type of benefit that indeed a CARLYSLE or obe-cel can induce in indications now beyond oncology in this case, in a refractory form of lupus -- systemic lupus.

第二項研究顯然進展順利。我們預期在今年年底前後會有數據——也就是 CARLYSLE 研究的更多補充數據；在該研究中我們已納入更多病患，同時——顯然——在該病患族群中也將有更長期、更多的追蹤。我認為這將讓我們非常清楚地理解，CARLYSLE 或 obe-cel 在腫瘤學以外的適應症中，確實能帶來何種程度的效益；在此案例中，是針對難治型狼瘡——系統性紅斑狼瘡。

The next study that is actively enrolling is the LUMINA study, which is in lupus nephritis. This is the Phase II study, where we have agreement with the agency to -- based on this study, aim for a registration in refractory lupus nephritis. The study is active in certain countries in Europe as well as the US and we're expecting data from the study in 2028.

下一項正在積極收案的研究是 LUMINA 研究，適應症為狼瘡腎炎。這是一項第二期研究，我們已與主管機關達成共識——將以此研究為基礎，目標是在難治性狼瘡腎炎上推進註冊申請。該研究已在歐洲部分國家以及美國啟動，我們預期於 2028 年取得研究數據。

Finally, the study that will get us into neurological diseases is the progressive multiple sclerosis study that we're conducting, which is the BOBCAT study. This study is continuing to enroll, and we expect initial data at the end of this year and then full data during the course of next year.

最後，將帶領我們進入神經疾病領域的研究，是我們正在進行的進行性多發性硬化症研究，也就是 BOBCAT 研究。該研究持續收案中，我們預期在今年年底取得初步數據，並在明年期間取得完整數據。

When we look a bit more broadly, we also obviously will have additional data collection through the ROCCA Consortium, which is actually continuing to collect information from patients treated with commercial product and actually starting to look at quite a range of questions related to the performance of the product and the properties of the product with a clear view from the real-world setting. In addition, and this was also part of the KOL call that I referenced before, we're seeing investigator-sponsored studies starting that actually are looking at the use of obe-cel in frontline consolidation setting, which is ultimately aiming to explore whether indeed an abbreviated frontline treatment might be possible, and we're obviously very interested to see how the product performs in those settings. And we expect our investigators to report in upcoming conferences on their studies.

若我們把視野放得更廣一些，顯然也會透過 ROCCA 聯盟進行額外的數據收集；該聯盟其實仍在持續蒐集使用商業化產品治療之病患的資訊，並開始從真實世界情境出發，針對產品表現與產品特性相關的一系列問題進行分析。此外——這也包含在我先前提到的 KOL 電話會議內容中——我們看到由研究者主導的研究正在啟動，這些研究實際上在探討 obe-cel 於一線鞏固治療（frontline consolidation）情境中的使用，最終目標是探索是否可能採用縮短的一線治療方案；我們當然非常關注產品在這些情境下的表現。我們也預期研究者將在即將到來的學術會議上報告其研究結果。

With that, I'm at the end of the introductory remarks, and I will hand over now to Rob for the financial results.

以上就是開場說明的最後部分，接下來我把時間交給 Rob 來說明財務結果。

Thanks, Christian, and good morning or good afternoon to everyone. It's my pleasure to review our financial results for the first quarter of 2026, and I'll be referring to slide 8 in the presentation. Total net product revenue for the first quarter of 2026 was $26.2 million compared with $9 million in the first quarter of 2025. This quarter reflects sales in the US and our first quarter in the UK market. Though given it is early in the launch, contribution from the UK was minimal.

謝謝你，Christian，也向各位道早安或午安。很高興向各位回顧我們 2026 年第一季的財務結果，我將參考簡報第 8 頁。2026 年第一季的產品淨營收總額為 2,620 萬美元，相較於 2025 年第一季的 900 萬美元。本季反映了美國的銷售，以及我們在英國市場的第一個季度。不過由於仍處於上市初期，英國的貢獻相對有限。

As Christian noted, we're pleased to shift to a positive gross margin during the quarter with $1.6 million compared to losses in prior quarters in 2025. With the combination of increasing product revenue and our cost reduction initiatives that Christian mentioned that are underway, we expect the margin expansion to continue as we move forward. Underlying that gross margin, cost of sales in the first quarter totaled $24.6 million. That's compared to $18 million for the same period in 2025. The increase primarily reflects costs related to higher AUCATZYL sales period-over-period.

如 Christian 所提，我們很高興本季毛利率轉為正數，毛利為 160 萬美元，相較於 2025 年先前季度為虧損。隨著產品營收增加，以及 Christian 提到、正在推進的成本降低措施，我們預期未來毛利率擴張將持續。在該毛利之下，第一季銷貨成本合計為 2,460 萬美元；相較於 2025 年同期的 1,800 萬美元。增加主要反映 AUCATZYL 銷售量年對年提升所帶來的相關成本。

Our research and development expenses decreased to $21.2 million for the first quarter of '26 from $26.7 million during the same period in 2025. This change was primarily due to a decrease in development activities, including clinical trial and clinical manufacturing supply costs as well as capacity mobilization costs, mostly all related to obe-cel.

我們的研發費用在 2026 年第一季降至 2,120 萬美元，低於 2025 年同期的 2,670 萬美元。此變動主要由於開發活動減少，包括臨床試驗與臨床製造供應成本，以及產能動員成本的下降，而這些多數都與 obe-cel 相關。

Our selling, general and administrative expenses increased to $39.9 million for the first quarter of 2026 compared to $29.5 million in the same period of 2025. This increase was primarily due to salaries, other employment-related costs and professional fees supporting commercialization activities in both the US and UK. In addition, this quarter also included one-time termination-related expenses related to the operational efficiency and cost reduction initiatives that we announced last month in April.

我們的銷售、一般及行政費用在 2026 年第一季增至 3,990 萬美元，較 2025 年同期的 2,950 萬美元增加。此增幅主要來自薪資、其他與僱用相關的成本，以及支援美國與英國商業化活動的專業服務費。此外，本季亦包含一次性之終止聘僱相關費用，與我們上月 4 月宣布的營運效率提升與成本降低措施有關。

Loss from operations for the three months ending March 31, 2026, was $59.5 million as compared to $65.2 million for the same period in '25. And finally, net loss was $71.6 million for the three months ended March 31, 2026, compared to $72 or $70.2 million for the same period in 2025. Our cash, cash equivalents and marketable securities at March 31, 2026, totaled $229.4 million as compared to $300.7 million at December 31, 2025. This decrease was primarily driven by net cash used in our operating activities.

截至 2026 年 3 月 31 日止三個月的營業損失為 5,950 萬美元，相較於 2025 年同期的 6,520 萬美元。最後，2026 年 3 月 31 日止三個月的淨損失為 7,160 萬美元，相較於 2025 年同期的 7,200 萬美元或 7,020 萬美元。截至 2026 年 3 月 31 日，我們的現金、約當現金及有價證券合計為 2.294 億美元，相較於 2025 年 12 月 31 日的 3.007 億美元。此下降主要由營運活動使用的淨現金所致。

As Christian noted, we are reiterating financial guidance issued in January that we expect between $120 million and $135 million in AUCATZYL net product revenue in 2026, including contribution from both the US and UK markets. And finally, based on our current operating plans, including the anticipated AUCATZYL net revenues, we expect that current and projected cash, cash equivalents and marketable securities will be sufficient to fund our operations into Q4 '27.

如 Christian 所提，我們重申 1 月發布的財務指引：我們預期 2026 年 AUCATZYL 產品淨營收介於 1.20 億至 1.35 億美元之間，包含美國與英國市場的貢獻。最後，基於我們目前的營運計畫（包含預期的 AUCATZYL 淨營收），我們預期現有及預估的現金、約當現金及有價證券足以支應營運至 2027 年第四季。

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

接下來我把時間交還給 Christian，請他以對預期里程碑的簡短展望作結。Christian？

Thanks, Rob. So when we look at the -- towards the end of this year, we have updates from three of our programs. We have the longer-term follow-up from the CARLYSLE study. We have initial clinical data from the BOBCAT Phase I in progressive MS. And we expect to have initial clinical data from the ALARIC Phase I study, that's the AUTO8 trial in light chain amyloidosis, which we're collaborating on with UCL also by year-end of this year.

謝謝你，Rob。那麼，當我們看向——今年年底前後，我們有三個專案的更新。我們將取得 CARLYSLE 研究的較長期追蹤結果；我們將取得 BOBCAT 第一/二期（Phase I）在進行性多發性硬化症（progressive MS）的初步臨床數據；並且我們預期在今年年底前取得 ALARIC 第一/二期（Phase I）研究的初步臨床數據，也就是在輕鏈類澱粉沉積症（light chain amyloidosis）的 AUTO8 試驗；該試驗我們也與 UCL 合作進行。

Full data then expected for the BOBCAT study during the course of 2027. The pediatric Phase II data readout is expected for year-end 2027 and the LUMINA Phase II data in lupus nephritis is expected in 2028. Those are the key updates and key milestones.

BOBCAT 研究的完整數據預期將在 2027 年期間取得。兒科第二期數據讀出預期在 2027 年底，LUMINA 在狼瘡腎炎的第二期數據則預期在 2028 年。以上是主要更新與關鍵里程碑。

And with that, we're opening up to questions.

接下來我們開放提問。

(Operator Instructions)

（接線員指示）

Gil Blum, Needham & Company.

Gil Blum，Needham & Company。

Congrats on the progress. So you're saying you're seeing some level of market expansion, older patients, maybe a bit patients for consolidation, that sort of thing. It didn't seem to change the guidance for this year. So I'd appreciate your commentary on that. And then I have a follow-up.

恭喜進展順利。所以你的意思是，你們看到某種程度的市場擴張——年長病患，或許也有一些病患用於鞏固治療之類的情況。但看起來這並沒有改變今年的指引。我希望你們能就此提供一些評論。另外我還有一個追問。

Yes. First of all, thanks a lot for joining, Gil. The dynamic we're seeing in the market is very positive. But obviously, this is -- we're still early in the year. I want to see the dynamic obviously play out into the -- into fuller aspect as we go through the course of the year.

是的。首先非常感謝你加入，Gil。我們在市場上看到的動態非常正面。但顯然，現在——我們仍處於年初。我希望看到這個動態在——在接下來一年進程中更完整地展現。

The guidance at this point, we believe, is reasonable, and there's no -- frankly, no reason for us to change the guidance at this point. But obviously, we'll keep monitoring the development and -- if indeed, we see a different trajectory, we obviously will update the market.

就目前而言，我們認為這份指引是合理的，而且——坦白說——目前沒有理由去調整指引。但我們當然會持續監測發展，並且——如果我們確實看到不同的走勢，我們也會更新市場。

Very helpful. As it relates to the LUMINA study, we just saw another registrational study come up, again, in lupus nephritis kind of like in a similar line of therapy. Are you guys seeing any potential challenges in enrollment? I mean, is it a little crowded?

非常有幫助。關於 LUMINA 研究，我們剛看到另一項註冊性研究出現，同樣是在狼瘡腎炎、而且治療線別有點類似。你們在收案上是否看到任何潛在挑戰？我的意思是，會不會有點擁擠？

Thanks, Gil. So the population we're going after is a proper refractory population that are post the standard of care, which is based on B-cell depleting antibodies as well as calcineurin inhibitors. So it's a very -- that's a pool that's currently not served by the standard of care, you beyond that. And the trial size that we need to recruit is very limited. We're looking at a 30-patient trial. And from that perspective and also given that we're running the study both in the US and outside the US, we believe we're in a good position to enroll the study. So we're not worried about that.

謝謝你，Gil。我們鎖定的族群是真正的難治性族群，也就是在標準治療之後的病患；標準治療包含 B 細胞耗竭抗體以及鈣調神經磷酸酶抑制劑。因此這是一個——這個族群目前在標準治療之外並未被滿足。且我們需要招募的試驗規模非常小，我們目標是一項 30 位病患的試驗。從這個角度來看，再加上我們同時在美國及美國以外地區進行研究，我們認為收案處於有利位置，所以我們不擔心。

Excellent. And maybe a last one on the multiple sclerosis. Can you remind us what level of data you think you may have in 2026?

很好。最後可能再問一題關於多發性硬化症。您能提醒我們，您認為在 2026 年可能會有到什麼程度的數據嗎？

So the BOBCAT study looks -- first of all, it's a dose escalation study. So we're starting at 100 million with an ability to go further up. So that's the basic design of the study. We expect to have initial information on the behavior, obviously, of the product with regards to safety, but also the dynamic, the cellular dynamics that we're seeing, which is important. You want to understand the ability of the product to expand in the periphery, but also look at the presence of the product in the CSF, obviously, on the other side of the blood-brain barrier.

BOBCAT 研究是這樣——首先，它是一項劑量遞增研究。我們從 1 億（細胞）開始，並且具備進一步往上調升的能力。這就是研究的基本設計。我們預期會先取得關於該產品表現的初步資訊，當然包括安全性，但也包括我們觀察到的動態、細胞動態，這點很重要。您會想了解該產品在周邊的擴增能力，同時也會觀察該產品在腦脊髓液（CSF）中的存在情況，當然是在血腦屏障的另一側。

And then certainly, we'll record the various types of markers that we have available here that actually monitor both either the inflammation -- inflammatory state of the disease as well as potential damage to tissue that you can monitor both with biochemical markers as well as with imaging.

接著，我們當然會記錄我們在此可用的各類標記物，這些標記物實際上可用來監測疾病的發炎——發炎狀態，以及可能的組織損傷；這些可同時透過生化標記物以及影像學來監測。

So we'll have early data in terms of the behavior. And then I think as we look into next year, I think we start to have more data points that look at the actual disease scores and the ability, obviously, and frankly, any potential impact on disease scores going forward. For that, you want to have several data points and a longer observation time to make sure you're not actually monitoring potential placebo effects or other types of impact that you might have given that part of those assessments are either physician or patient reported. So hard measures for this year, mostly on the actual behavior and safety. Behavior from a pharmacodynamic perspective and pharmacokinetic markers, but also then as we go into next year, looking into the actual disease scores themselves.

因此，我們會先有一些關於其表現的早期數據。然後我認為，當我們展望明年時，我們會開始有更多數據點來觀察實際的疾病評分，以及其能力——坦白說——未來對疾病評分可能造成的任何影響。為此，您需要多個數據點以及更長的觀察時間，以確保您並非在監測潛在的安慰劑效應或其他類型的影響，因為其中一部分評估是由醫師或病患回報。因此，今年的硬性指標主要會聚焦在實際表現與安全性；表現包含藥效學角度以及藥物動力學標記物；而進入明年後，則會看疾病評分本身。

Simon Baker, Rothschild & Company Redburn.

Simon Baker，Rothschild & Company Redburn。

Two, if I may, please. Christian, I just wonder if you could give us a little bit more detail on the mechanics of the UK rollout. And as I believe there are 20 CAR-T centers that, in principle, could administer AUCATZYL. What's the cadence of rolling those out in terms of getting centers on board?

如果可以的話兩個問題。Christian，我想知道您是否能就英國推廣（rollout）的運作機制提供更多細節。據我了解，原則上有 20 家 CAR-T 中心可以施打 AUCATZYL。就讓各中心加入（on board）的進度節奏而言，會如何推進？

How does this compare with the experience in the US? Any color on that would be helpful. And then on the R&D expense, it was lower than expected in the quarter because of clinical trial activity. I just wonder if you could give us any more color on the evolution of R&D spend as the year goes on.

這與美國的經驗相比如何？若能補充一些說明會很有幫助。另外關於研發費用，本季因臨床試驗活動而低於預期。我想請問您能否就今年接下來研發支出的走勢提供更多說明。

Okay. Thank you. Thanks a lot for joining. With regards to the UK rollout, we actually see a dynamic that we think is at least as quick as what we saw in the initial phase in the US it might actually be quicker. One of the things that is positive about the UK system is that the decision whether or not a patient would actually go on a CAR-T therapy or not is actually centrally made, which actually accelerates decision-making. That's actually a benefit of the way that is organized rather than individual center by center, physician-by-physician decision that is normal in other health care systems. So there are elements actually that are allowing us to probably move even a bit faster than we were able to do in the US.

好的。謝謝。非常感謝各位參與。關於英國的推廣，我們看到的動態，我們認為至少與美國初期階段一樣快，甚至可能更快。英國體系的一個正面之處在於，病患是否接受 CAR-T 治療的決策是由中央統一做出，這實際上加速了決策流程。這是其組織方式的優勢，而不是像其他醫療體系那樣，通常由各中心逐一、甚至逐位醫師來做決定。因此，有些因素讓我們可能比在美國時更能加快推進。

And we see very positive dynamic, very positive messaging also around from the NHS. NHS gave -- there were interviews held on television in the UK, et cetera. So there was quite a lot of presentations and work that the NHS itself did, frankly, increasing the awareness of the product and the opportunity for this new treatment modality for patients. So I think from an awareness perspective as well as from a drive perspective that we see in the center base and then the initial decision-making process or the internal decision-making process basically being going through a single body to take the decisions, I think, is actually very helpful, and we expect a good rollout here in the UK.

我們也看到非常正向的動能，以及來自 NHS 的非常正面的訊息。NHS 也有——英國電視上有進行訪談等等。因此，NHS 本身做了相當多的宣導與工作，坦白說，提高了對該產品的認知，以及讓病患了解這種新治療模式的機會。所以我認為，無論是認知層面，或是我們在中心端看到的推動力，再加上初始決策流程或內部決策流程基本上是透過單一機構來做決策，我認為這非常有幫助，我們也預期在英國會有良好的推廣進展。

With regards to R&D expense, I think I'll start, and then I'll hand over to Rob. I think what's important on the R&D expense, obviously, there is some changes as we see our activity with regards to clinical trials as you transition from one trial phase to another trial phase that usually slows down a little bit the enrollment in that process. There can be some fluctuations. But also if we look back into last year, obviously, there was still quite a lot of work that was ongoing related to the longer-term follow-up of the FELIX study that actually that work will be reduced over time as we're sort of obviously ramping up some of the other clinical activities. So there are quite important trade-offs there that we have on actual clinical trial activity.

關於研發費用，我先說明，然後再交給 Rob。我認為研發費用的重要點在於，隨著臨床試驗活動的變化——當您從一個試驗階段轉換到另一個試驗階段時，通常入組會稍微放慢——因此會有一些波動。另外，如果回頭看去年，顯然仍有相當多與 FELIX 研究長期追蹤相關的工作；隨著時間推進，這些工作會逐步減少，而我們同時也在逐步提升其他臨床活動。因此，在實際臨床試驗活動上，我們確實存在相當重要的取捨。

And then the other area is really the mobilization of additional capacity at The Nucleus, which we're obviously kind of taking on as we're sort of ramping now the demand in the US. And we also had some activities still ongoing during the course of last year. Those activities will substantially be reduced or pretty much are coming to a stop. And so we actually have now an ability to -- obviously, we'll have certain of those activities, which are also R&D-related costs as you mobilize the activity will start to obviously be reduced, while at the same time, we start increasing, obviously, our clinical trial costs. So we expect all in all, that there's going to be very helpful trade-offs and also we'll keep overall that R&D expense at a fairly steady level.

另一個領域則是 The Nucleus 額外產能的動員，我們在美國需求正在提升之際，當然也在同步推進。去年期間我們也仍有一些相關活動在進行。這些活動將大幅減少，或幾乎已接近停止。因此，我們現在有能力——當然，當您動員產能時，其中某些活動也屬於研發相關成本——這些成本將開始下降；同時，我們也會開始提高臨床試驗成本。因此，整體而言，我們預期會有非常有利的取捨，並且我們也會讓研發費用整體維持在相對穩定的水準。

Rob, do you want to add anything?

Rob，你想補充什麼嗎？

Yes. I mean the only additional thing I can add, Simon, I think Christian covered it really well. Another example I'd throw out there certainly was our pediatric study, where it was at a stage where we had that kind of first cohort enrolled and was still active at sites. That was part of the data presentation that happened at the end of last year. But in terms of getting this next wave up and going, we're more in kind of a valley and now we're in the enrollment for the expansion cohort.

是的。我想我唯一能補充的，Simon，我認為 Christian 已經說得非常完整。另一個例子是我們的兒科研究，當時處於第一個隊列已入組、且各研究中心仍在進行的階段。那也是去年年底資料發表的一部分。但就啟動下一波而言，我們目前比較處於一個低谷期，而現在正進入擴增隊列的入組。

And certainly, as we start treating more patients, both in the clinical programs, even on some of the investigator-sponsored trials that we have out there that Christian mentioned, you will see more clinical supply-related costs that will come in. But this is going to kind of move kind of up and down a little bit. We're not projecting any significant add of infrastructure, et cetera, on the R&D side.

而且，隨著我們開始治療更多病患——不論是在臨床計畫中，甚至是在 Christian 提到的一些研究者發起試驗（investigator-sponsored trials）中——您會看到更多與臨床供應相關的成本進來。但這會有些上上下下的波動。我們並未預期在研發端會有任何顯著的基礎設施新增等。

Salim Syed, Mizuho.

Salim Syed，Mizuho。

Congrats on the quarter. Just one for us on the data that we're expecting this year, Christian and Rob, it sounds like for the MS, the more important data set is going to be coming in '27. I don't know if you sort of interpret the same way for ALARIC. I'm just trying to balance how important do you guys deem these data sets coming at year-end? Are we expected to get any sort of bogey or how you guys are deeming what is the successful outcome on these year-end measures?

恭喜本季表現。我們這邊只有一題，關於今年預期會看到的數據，Christian 和 Rob，聽起來對 MS 而言，更重要的數據集會在 2027 年出來。我不確定你們是否也以同樣方式解讀 ALARIC。我只是想權衡一下：你們認為年底這些數據集的重要性有多高？我們是否應該期待任何基準（bogey），或你們如何界定年底這些衡量指標下的成功結果？

I'm just trying to balance that with just the cash runway here of 4Q '27.

我也想把這點與目前現金跑道到 2027 年第四季做個平衡。

Yes. So when we look at the nature of the MS study, obviously, we're collecting data points on disease score. And in order to actually get, I think, a good sense of the trajectory of the disease score, you need to have a certain amount of observation period. We obviously collect the data. We'll have an initial view on that.

是的。所以當我們看 MS 研究的性質時，顯然我們正在收集疾病評分的數據點。而要真正對疾病評分的走勢有一個良好的掌握，您需要一定的觀察期間。我們當然會收集數據，也會對此有初步的觀察。

But to actually be -- make a strong statement about the trajectory that you'll see after a few months is probably not sufficient. I know there is a temptation to do that, and there is certainly -- we see that sometimes in the market that that's been done. But we believe with those types of data points, we actually want to have a little further out a view. And with that, I think that more stable data.

但若要——對於幾個月後會看到的走勢做出有力的陳述，可能仍不夠。我知道確實會有這樣的誘惑，而且我們也確實看到市場上有時會這麼做。但我們認為，對於這類數據點，我們希望把視角放得更往後一些。如此一來，我認為數據會更穩定。

On the ALARIC study, I think what we do have is certainly an initial good understanding of the level of activity we have in this disease setting. We haven't actually reported on that before. And I think that should give us a good feel for the level of activity that we're seeing and the impact we're seeing in these patients. So I think that's certainly going to be a data point that we're obviously -- I think will be very helpful and will certainly from a readout perspective, I think will certainly be interpretable in a clear way. And -- but the other aspect, I think, is also getting back to the MS program.

關於 ALARIC 研究，我認為我們目前確實已對在此疾病情境中的活性水準有了初步且良好的理解。我們過去其實尚未就此進行報告。我認為這將讓我們對所觀察到的活性水準，以及在這些患者身上所看到的影響，有更好的掌握。因此我認為這無疑會是一個數據點——顯然我們會關注——而且我認為它將非常有幫助；從讀出（readout）的角度來看，我認為也將能以清楚的方式加以解讀。而——不過我認為另一個面向，也是在回到 MS 計畫上。

I think one of the things to sort of be clear about is that the importance here is, on the one hand, in the short for the data point at the end of the year, is the ability to demonstrate that indeed the product actually can be -- give us a safe product profile in these patients, which I think is very important for these patients. But also then actually have -- be able to actually show that indeed, the product is active in the CSF and with that in the central nervous system. I think that actually is a key piece of the information and it really goes to the foundation of the rationale for using the cell-based product because that allows us to actually get into the -- across the blood-brain barrier and with that, have an ability for activity.

我認為有一點需要先釐清：這裡的重要性在於，一方面，短期來看、在年底的那個數據點，是能夠證明該產品確實可以——在這些患者中提供安全的產品特性（profile），我認為這對這些患者非常重要。但另一方面，也要能夠實際顯示：該產品在 CSF（腦脊髓液）中是有活性的，並因此在中樞神經系統中也有活性。我認為這其實是關鍵資訊之一，並且直接關係到使用細胞型產品的理論基礎，因為這讓我們能夠實際進入——穿越血腦屏障，並因此具備產生活性的能力。

And just as a reminder for some of you, if you haven't actually been able to listen to the KOL call, Lori Muffly did present one of her patients that had explosive ALL or filled up bone marrow, the disease strongly, frankly, intruding into the brain and into the CSF and frankly, putting pressure onto the spine directly leading to the patient becoming paraplegic. What she described is that she treated the patient with AUCATZYL, which she thought was the only treatment she could give the patient that would be actually safe enough.

另外提醒各位，如果你們還沒有機會收聽 KOL 電話會議，Lori Muffly 確實分享了她的一位患者：該患者有爆發性的 ALL，或骨髓被疾病大量佔據；疾病非常強勢，坦白說，已侵入腦部與 CSF（腦脊髓液），並且坦白說，直接對脊髓造成壓迫，導致患者出現截癱。她描述說，她以 AUCATZYL 治療該患者，並認為這是她能提供、且在安全性上足夠的唯一治療。

And what she was seeing is that the patient within 28 days had actually the leukemia taking care of MRD negative in the periphery, but also obviously, clearance in the CNS and the patient actually recovered mobility and control over her body. So that tells you a lot about the ability of the product to cross the blood-brain barrier to be very active and remove CD19 positive cells, in this case, also leukemic cells in the brain to a point where indeed there is massive improvement that could be seen in the patient. But that's really at the heart of the feature, which is unique to this type of a therapy, and that's really what we're building on for the BOBCAT study in progressive MS.

她所觀察到的是，患者在 28 天內，白血病在周邊達到 MRD 陰性；同時也很明顯地在 CNS（中樞神經系統）獲得清除，而患者實際上恢復了活動能力與對身體的控制。這充分說明該產品能穿越血腦屏障、具有很強的活性，並清除 CD19 陽性細胞——在此案例中也包括腦部的白血病細胞——以至於患者出現可見的巨大改善。但這正是此類療法獨特特性的核心，而這也正是我們在進行進行性 MS 的 BOBCAT 研究時所要建立與延伸的基礎。

James Shin, Deutsche Bank.

James Shin，德意志銀行。

First one, I appreciate AUCATZYL achieving positive gross margin this quarter. And pending AUCATZYL's top line growth and with the RIF in place, could we see Autolus becoming profitable on a company level basis by, say, late '27? And second question, between Besponsa and Blincyto, is Blincyto the main bridge before patients receive AUCATZYL? And does the bridging tend to align with AUCATZYL's manufacturing turnaround time?

第一個問題，我很欣賞 AUCATZYL 本季達成正的毛利率。若 AUCATZYL 的營收（top line）持續成長，且裁員（RIF）已到位，我們是否可能在公司層級於例如 2027 年底前後看到 Autolus 轉為獲利？第二個問題，在 Besponsa 與 Blincyto 之間，Blincyto 是否是患者接受 AUCATZYL 前的主要橋接治療？而橋接治療的使用是否通常會與 AUCATZYL 的製造週轉時間相匹配？

Thanks, James. Very good question. So the first related to kind of the trajectory for the ALL business. What we're projecting for the ALL business is that we're going to cross the line to profitability in the ALL business in 2028. Whether or not the company will actually be profitable at that point also depends on the reinvestment rate that we'll have in the upcoming 1.5 years towards that time point. So that's going to be the key driver whether or not we're going to be -- can be profitable as a company or not by that time point. But as an ALL business, we expect to cross that line in 2028.

謝謝你，James。非常好的問題。第一個問題與 ALL 業務的發展軌跡有關。我們對 ALL 業務的預期是：在 2028 年，ALL 業務將跨越獲利門檻。至於公司在那個時間點是否也能獲利，還取決於在接下來約 1.5 年內、我們在那個時間點之前的再投資速度（reinvestment rate）。因此，這將是決定我們屆時是否能以公司層級獲利的關鍵驅動因素。但就 ALL 業務而言，我們預期在 2028 年跨越獲利線。

With regards to the bridging therapies that are employed for AUCATZYL, typically, you would use for bridging either chemotherapy or inotuzumab or Besponsa, you would not use Blincyto. And the reason for Blincyto is this is when a treatment when you started, it should go for -- it's basically a continuous IV infusion for four weeks, which is actually longer than the manufacturing turnaround time for these patients, and that actually wouldn't make sense. So we don't actually see the use of Blincyto for bridging in -- with our product. It's mostly driven by chemotherapy and/or inotuzumab.

至於 AUCATZYL 所採用的橋接治療（bridging therapies），一般而言，橋接會使用化療或 inotuzumab（或 Besponsa），不會使用 Blincyto。原因在於，Blincyto 一旦開始治療，就需要——基本上是連續靜脈輸注四週，這其實比這些患者的製造週轉時間還要長，因此並不合理。所以我們並未看到 Blincyto 作為我們產品橋接治療的使用；主要是由化療和／或 inotuzumab 所驅動。

Matthew Phipps, William Blair.

Matthew Phipps，William Blair。

I guess could you maybe characterize a little bit of the growth that you've seen this quarter? Is it from greater utilization at current centers? You mentioned expansion in older patients? Or is it mainly expansion into new centers? I guess what percent of the market do you think you'll have covered when you reach the 80 centers by the end of this year?

我想請你們稍微描述一下本季看到的成長來源：是來自既有中心的使用率提升嗎？你們提到在年長患者中的擴張？還是主要來自新增中心的擴張？另外，當你們在今年底達到 80 個中心時，你們認為大概能覆蓋市場的百分之多少？

Thanks, Matt. So when we look at the growth, we see that actually, given that we already have 73 centers on when you compare to the beginning of the year, we were at about 65. The majority obviously comes from the centers that were already active. And that's where you see the repeat use and you see that build up. The new centers obviously gradually build on, but their initial activity is going to be limited. There's going to be one or two patients, initial experience gained and then that eventually translates further. So we see a lot of good positive momentum out of the centers.

謝謝你，Matt。當我們看成長時，我們看到的是：目前我們已有 73 個中心；若與年初相比，當時大約是 65 個。主要的成長顯然來自已經在運作的中心；你會看到重複使用，並看到量能逐步累積。新中心當然會逐步貢獻，但其初期活動會比較有限，可能只有一到兩位患者，先累積初期經驗，之後才會進一步轉化。因此我們看到各中心帶來相當好的正向動能。

One of the metrics we're looking at is also not just the centers themselves because when you look into the centers, what you do see initially is that typically, it's a small number of physicians that might actually use product. And what you really want to do is you want to see actually the group of physicians using the product increase per center. So one of the metrics we're looking at is obviously the physicians that are actually using the product, and we actually see very nice progression in terms of the numbers of physicians using the product and actually dosed the patient. So we kind of track that as one of the key metrics, and we clearly see that dynamic.

我們觀察的其中一個指標也不只是中心數本身，因為當你深入看中心內部，初期通常只有少數醫師可能會使用該產品。你真正希望看到的是：每個中心內使用該產品的醫師群體逐步增加。因此我們追蹤的其中一個指標，顯然就是實際使用該產品、並為患者給藥的醫師數量；我們確實看到使用該產品的醫師人數有非常好的進展。我們把這作為關鍵指標之一來追蹤，也清楚看到這樣的動態。

And for the most part, that expansion actually is within the centers we're already active in, and we're starting to see broader adoption. And that's really how ultimately you will build market share. It's the use of the product by most of the physicians at each given center across the range of the indication and the label, and that gives you really the ability to grow that market share. Overall, we do believe we see very good dynamic in terms of increasing the market share, obviously, as we're going forward. And based on just our guidance, you would expect that we would have a substantial increase in the overall market share that we're projecting, obviously, for 2026, and that's the guidance we have reiterated.

而在很大程度上，這種擴張其實發生在我們已經活躍的中心內，我們開始看到更廣泛的採用。這也正是最終建立市占率的方式：在每個中心，讓大多數醫師在適應症與標籤（label）的範圍內使用該產品，這會真正帶來擴大市占的能力。整體而言，我們確實認為，隨著我們往前推進，市占率提升的動態非常良好。並且僅根據我們的指引（guidance），你會預期我們在 2026 年的整體市占率將有顯著提升；這也是我們已再次重申的指引。

Emily Bodnar, H.C. Wainwright.

Emily Bodnar，H.C. Wainwright。

Maybe a follow-up from the prior question. Can you kind of comment on what contribution UK revenue had on growth in the first quarter and how you're kind of expecting that to play out for the remainder of 2026? And then maybe on the data update for SLE and LN later this year, if you can kind of talk about what level of durability you're hoping to see in the updated data and also response rates for the 100 million dose.

也許延續上一題。你們能否談談第一季成長中，英國營收的貢獻大概是多少，以及你們預期在 2026 年剩餘期間會如何發展？另外，關於今年稍晚 SLE 與 LN 的數據更新，你們能否談談在更新數據中希望看到的持久性（durability）水準，以及 1 億劑量的反應率？

All right. Thanks a lot, Emily. Thanks for joining. So for UK sales, given that the UK is obviously a fraction of the size of the US we decided not to actually break out UK sales numbers, certainly initially in the launch because frankly, it doesn't make much sense. It is too early in the process. We expect to break it out likely towards the end of the year.

好的。非常感謝你，Emily。也謝謝你加入。關於英國銷售，由於英國的市場規模顯然只是美國的一小部分，我們決定在上市初期不單獨揭露英國銷售數字，坦白說，這樣做意義不大，因為目前仍處於非常早期的階段。我們預期可能會在年底左右開始單獨揭露。

But for the first quarter, that doesn't actually make much sense at this point because obviously, a lot of the products would still be -- patients would roll in, you start to produce initial products and then you start to actually see the momentum translated into actual sales numbers.

但就第一季而言，現階段其實不太合理，因為很明顯，許多產品仍會是——病患會陸續進來，你開始生產初期產品，然後才會開始看到動能轉化為實際的銷售數字。

With regards to the LN update, obviously, we have patients that will have about 12 months or more follow-up in terms of the initial cohort. I think that is going to be very meaningful because it tells us a lot about not just the initial safety and the initial reset, but then also whether -- how the B cell compartment sort of reconstitutes over time. And with that, then also the ability to see sustained response in these patients going forward, which is one of the key elements and metrics that we're looking at.

關於 LN 的更新，很明顯，我們在初始隊列中會有病患具備約 12 個月或更長的追蹤期。我認為這將非常有意義，因為它不僅告訴我們初期的安全性與初期的重置情況，也能讓我們了解——B 細胞區室隨時間如何重新建構。並且藉此也能觀察這些病患未來是否能維持持續反應，這是我們正在關注的關鍵要素與指標之一。

And then obviously, for the other patients, which include a higher dose cohort as well as adolescent patients, we're obviously going to have a limited follow-up. So that's going to be mostly around the initial response, the safety, the initial response and initial kind of recovery of the B-cell compartment. But obviously, that will have a limited follow-up compared to what we will have from the first cohort, where we're going to be certainly beyond the year of follow-up.

然後很明顯，對於其他病患（包括較高劑量隊列以及青少年病患），我們的追蹤期會相對有限。因此重點將主要放在初期反應、安全性、初期反應以及 B 細胞區室的初步恢復。不過很明顯，與第一個隊列相比，這些病患的追蹤期會較短；而第一個隊列我們肯定會超過一年的追蹤。

Jacob Mekhael, KBC Securities.

Jacob Mekhael，KBC Securities。

I have a few, if I may. First of all, just on the gross margin. You mentioned in one of the slides earlier that you expect it to be 65% to 70% at peak. Curious, do you plan to provide peak sales guidance at some point in the future? And when would be the right time to do that in your view?

如果可以的話我有幾個問題。首先，關於毛利率。你們在先前的一張投影片提到，預期在高峰時毛利率可達 65% 到 70%。我想了解的是，你們是否計畫在未來某個時間點提供高峰銷售（peak sales）指引？在你看來，什麼時候會是合適的時點？

That's the first one. And then maybe I have a follow-up on the -- on your agreement with Cellares for the manufacturing. Is there a timeline by which you need to have a formal agreement in order to incorporate that into the new manufacturing process for the pivotal program in autoimmune.

這是第一個。接著我可能有一個追問，關於——你們與 Cellares 的製造合作協議。為了將其納入自體免疫關鍵性（pivotal）計畫的新製造流程，你們是否需要在某個時間點之前簽訂正式協議？是否有時間表？

All right. Well, first, thanks for joining, Jacob. First, with regards to the gross margin reference on peak sales, I think what we have been pointing out with regards to the overall opportunity in the relapsed/refractory setting in the US is that we have approximately 1,600 to 1,800 patients. And we have seen certainly with other agents before that you can get with a good profile up to about 60% penetration, which we expect or market share, which we expect kind of the upper end of the range is in the relapsed/refractory setting.

好的。首先，謝謝你加入，Jacob。第一，關於毛利率與高峰銷售的提問，我想我們一直在指出的是：在美國復發／難治（relapsed/refractory）情境下的整體機會，我們大約有 1,600 到 1,800 名病患。而且我們也確實看到，過去其他藥物若具備良好的特性，滲透率最高可達約 60%；我們預期在復發／難治情境下，市場滲透或市占的上緣大致就在這個範圍。

So that's kind of where we are and I think where we sort of see the opportunity. I think to guide towards a more formal peak sales, I think that's premature at this point in time. But I think it gives you a good understanding of kind of the overall size of the market and the overall opportunity that we're sort of identifying for the product.

所以這就是我們目前的位置，也是我們看待機會的方式。我認為要在此時提供更正式的高峰銷售指引，現在還為時過早。但我想這能讓你對市場的整體規模，以及我們為該產品所辨識的整體機會，有一個不錯的理解。

With regards to the Cellares timing, we're in the midst of a feasibility study. So we want to understand where the product actually produced on that technology platform versus the platform we're using at The Nucleus today, how the products compare. And so that's a key analysis that we're running. That's what we're really going to be focusing on this year. And if that data turns out positive, that's I think the timing -- the time point to actually take the next steps.

關於 Cellares 的時程，我們正在進行可行性研究。因此我們想了解：在該技術平台上生產出的產品，與我們目前在 The Nucleus 使用的平台所生產的產品相比，兩者的產品表現如何、可比性如何。這是我們正在進行的關鍵分析，也是我們今年真正會聚焦的重點。如果數據結果正面，我認為那就是——實際採取下一步行動的時點。

In terms of being in time, we believe that the key area where I think that technology, I think, could be attractive to us is if we're sort of getting to a step change in the need for product. we believe that, that step change certainly could come from an indication like progressive MS. And I think that's sort of where we're looking to sort of actually work through and make sure that we have an option there that would allow us to actually scale production in a reasonable and economical way as well.

就時程是否來得及而言，我們認為該技術可能對我們具有吸引力的關鍵領域，是當我們面臨產品需求出現階躍式（step change）提升的情況。我們相信，這種階躍式提升很可能會來自像進行性 MS 這樣的適應症。我想這就是我們正在努力推進並確認的方向，確保我們有一個選項，能讓我們以合理且具成本效益的方式擴大產能。

So that's sort of where -- frankly, the elements that are being connected. But for this year, it's really around making sure we get the clear data from the feasibility and our understanding that whether this quality of the product we're getting actually is comparable.

所以——坦白說，這些要素正在被串連起來。但今年的重點，確實是要先確保我們從可行性研究中取得清楚的數據，並理解我們所得到的產品品質是否真的具有可比性。

Roger Song, Jefferies.

Roger Song，Jefferies。

This is Fiona on for Roger. Just a couple from us. On the AUCATZYL revenue, how should we think about the near-term and long-term growth driver? And any active measures you're taking to further the penetration in the US versus ex US dynamics? And just another one, understanding that you're going to switch to a positive gross margin from this quarter. Do you see any further optimization needed moving forward? Or do you want to see the impact of the cost reduction play out?

我是代 Roger 發言的 Fiona。我們這邊有幾個問題。關於 AUCATZYL 的營收，你建議我們如何看待短期與長期的成長驅動因素？以及你們是否有任何積極措施，來進一步提升美國的滲透率，相較於美國以外市場的動態？另外一個問題是，理解你們從本季開始會轉為正毛利率。往後你們是否還需要進一步優化？還是你們想先觀察成本降低措施的效果逐步反映？

Thanks a lot, Fiona. First with regards to the revenue drivers. Clearly, what -- there's two key elements here. There's sort of getting to a large percentage of the patients that -- or the market you can cover in terms of access -- patient access to centers, we believe that we're in this 80-plus center range, we're getting to certainly in the range of 80% of the patients that we can actually cover from that perspective, which I also believe is an add-on answer to what Matt was asking as well before.

非常感謝，Fiona。首先談營收驅動因素。很清楚——這裡有兩個關鍵要素。其一是，在可及性方面，讓我們能覆蓋市場中相當比例的病患——也就是病患能進入治療中心的可及性；我們認為目前大約在 80 多家中心的範圍，從這個角度來看，我們已經能覆蓋大約 80% 的病患。我也認為這同時也補充回答了先前 Matt 的問題。

What really drives the ability for -- to drive the market share up, and this is in any jurisdiction that you're active in, is really getting the physicians at a given center to use the product consistently, gain experience and gain confidence. And with that, starting to use the product in the first place for typically a limited number of patients, which is sort of typically patients they think they cannot serve with the standard of care that they have experience with, gain experience with the product and then actually start to apply the product much more widely across the full range of the label. We've seen that play out actually during clinical trials, and we see it play out also now in the marketplace as well. So that is really what drives ultimately the market share is the conviction of the physicians that this product actually allows you to treat a wide range of patients.

真正驅動——推升市占能力的因素（這在你所營運的任何司法管轄區都一樣），其實是讓特定中心的醫師能夠持續使用該產品、累積經驗並建立信心。隨之而來的是，醫師一開始通常會先在少數病患身上使用該產品——通常是他們認為用自己熟悉的標準治療無法妥善處理的病患——先累積對產品的使用經驗，然後才會開始在標籤適用範圍內更廣泛地使用。我們在臨床試驗期間就看到這種情況發生，而現在在市場上也同樣正在發生。所以，最終真正驅動市占的，是醫師的信念：這個產品確實能讓你治療更廣泛範圍的病患。

And again, Lori made these types of comments actually also at the call that we had organized. And what she was talking about is the ability to actually have an option with AUCATZYL that irrespective of modality actually gives you a safe way of treating patients and actually allows us to treat patients she would not have even considered treating before. And that was actually not a differentiation between CAR-T products, but across the range of product options and modalities that she has available. That's kind of an expression of that level of confidence. And I think that is where we see, I think, the biggest growth is for physicians to get to that place.

同樣地，Lori 在我們安排的那場電話會議上也發表了類似的評論。她談到的是：使用 AUCATZYL 作為一個選項，不論治療模式（modality）為何，都能提供一種安全的方式來治療病患，並且讓我們能治療一些她以前甚至不會考慮治療的病患。那其實不是在 CAR-T 產品之間做區隔，而是在她可用的各種產品選項與治療模式之間的比較。這正是那種信心程度的展現。我認為我們看到最大的成長空間，就是讓醫師能達到那樣的狀態。

That's also where the ultimate decision-making resides is obviously with the physician. The patients receive the product once. It's a one-time experience for the patient. It's a repeat experience for the physicians. And that's really what's your foundation and what's really driving this. And this is true whether this is in the US or it's in the UK or elsewhere.

而最終的決策當然也在醫師手上。病患只會接受一次產品治療，對病患而言是一次性的體驗；但對醫師而言是可重複的體驗。這才是你的基礎，也是驅動一切的核心。不論是在美國、英國或其他地方，都是如此。

With regards to the opportunity to sort of expand beyond the US, obviously, we're active in the UK at this point. We continue conversations in Europe. And we're navigating market access and MFN topics in Europe. And obviously, we need to make sure we get to reasonable places there.

至於擴展到美國以外市場的機會，很明顯我們目前已在英國展開。我們也持續在歐洲進行對話，並且正在處理歐洲的市場准入以及 MFN 相關議題。我們當然需要確保在那裡能達到合理的結果。

At this point, we're not guiding for European sales. We're obviously approved. We continue those conversations. And we'll certainly, once we actually get through market access in first European countries, we'll obviously inform everyone on that. But this is an ongoing process and certainly somewhat delicate also with the policy changes that we see across the board that we need to take into account.

目前我們不提供歐洲銷售指引。我們已經獲准上市，也持續進行相關對話；一旦我們在首批歐洲國家完成市場准入，我們當然會向大家更新。不過這是一個持續進行的流程，而且考量到我們看到各方面的政策變動，也確實相對敏感，需要納入考量。

And then finally, optimization. The final question, I think you had was on optimization. Actually, optimization certainly from a manufacturing process is a continuous process. It's not just a one-off. But we made some very significant changes in our operating model that are now implemented, and we continue to improve as we go through literally every step along the way of the manufacturing process.

最後是最佳化。我想你最後一個問題是關於最佳化。其實，從製造流程的角度來看，最佳化當然是一個持續的過程，不是一次性的。但我們已經對營運模式做出一些非常重大的變更，且目前已落地實施；同時，我們也會在製造流程的每一個步驟中持續精進。

And what we're really aiming for is to make sure that the hours of work that go in to produce every single product can be minimized. And so it's really a drive to minimize the work spent per product. At the same time, obviously, we want to reduce the overall contribution from the fixed cost, and that's really -- that particular aspect is driven by the volume of products you run through the facility.

我們真正的目標是確保生產每一項產品所投入的工時能夠降到最低。因此，這確實是在推動把每件產品的工時投入最小化。同時，顯然我們也希望降低固定成本的整體占比，而這一點主要是由你在該設施中所處理的產品產量所驅動。

And those are the two key metrics that actually are driving ultimately your cost down per product. One is the total volume and with that, a reduction of the fixed cost allocation and then also a reduction of -- a reduced number of work hours per product. And that's really what we're driving at, and we'll see a very significant steady impact as we go over the upcoming probably two years.

而這兩項就是最終推動單位產品成本下降的兩個關鍵指標：一是總產量，隨之帶來固定成本分攤的降低；二是每件產品所需工時的下降。這正是我們努力的方向；在接下來大概兩年內，我們將看到非常顯著且穩定的影響。

Shyam Kotadia, Goldman Sachs.

Shyam Kotadia，高盛。

Just two from my end. So on the gross margin that reached positive this quarter, how should we think about that cadence for the rest of this year? Should we expect a steady improvement? And what is your target gross margin, I guess, for full year '26? And also on that peak margin you mentioned, when are you expecting to reach that?

我這邊兩個問題。關於本季毛利率轉正，接下來今年其餘時間的節奏應該怎麼看？是否預期會穩步改善？另外，你們對 2026 全年的目標毛利率大概是多少？以及你提到的峰值毛利率，預計何時能達到？

That's the first one on gross margin. And then the second one on multiple sclerosis. I know it's early, but I just wanted to see if you guys could provide any color on your commercialization plan there? Are you planning to go at this yourself? Or would you look to partner or in-license for this indication?

第一個是毛利率。第二個是多發性硬化症（MS）。我知道還很早，但想請你們分享一下商業化計畫的方向？你們打算自行推進，還是會考慮就這個適應症尋求合作夥伴或引進授權（in-license）？

Thank you very much. So with regards to the gross margin, we expect to actually see continuous improvement over the growth of the gross margin as we go through the course of this year. We obviously have implemented significant improvement in the operating model in the first few months this year. They will start to actually have impact in terms of the cost as we get through the remainder of the year. I think we'll see sort of an increased impact over time.

非常感謝。關於毛利率，我們預期今年接下來的期間，毛利率將會持續改善。我們在今年前幾個月已經在營運模式上落實了重大改善；隨著今年剩餘時間的推進，這些改善將開始在成本端產生影響。我認為其影響會隨時間逐步放大。

And at the same time, we'll see, obviously, and we expect an increase in terms of the volume of product that we're running through the facility as well. And those two parameters will actually be supportive to really see a continuous improvement of the gross margin. We haven't given guidance on where we expect to be by the end of this year. But obviously, it's a metric that we continuously report, and I think you'll start to get a good understanding and feel for the dynamic as we go through the next few quarters. So that's the first part of the question.

同時，我們也會看到——而且我們預期——在該設施中所處理的產品量也會增加。這兩個參數將共同支撐毛利率的持續改善。我們尚未提供今年年底毛利率的指引；但這顯然是我們持續揭露的指標，我想在接下來幾個季度，你會開始對其動態有更好的理解與掌握。以上是第一部分。

The second is, when do we expect peak typically to get through to peak sales in indications like ALL, that's probably taken between four and five years. But the main impact that you will see from a gross margin perspective is likely going to be somewhat earlier because the -- if you get to a certain level of volume of product you run through the facility, the amount of improvement you get on the fixed cost contribution obviously becomes limited. You're running an asymptotic line.

第二個問題是，我們預期何時達到峰值。通常像 ALL 這類適應症，要達到峰值銷售大概需要四到五年。但從毛利率的角度來看，你會看到的主要影響可能會更早出現，因為——當你在該設施中達到一定的產品處理量後，固定成本占比改善的幅度顯然會變得有限；你會沿著一條漸近線運行。

And obviously, the big gains that we expect on productivity and with that reduction of labor cost is expected to happen actually during the course of this year. And then there may individual elements where we might actually introduce particular improvements on technology that can actually lead again to a step change, but those will not be -- those obviously will take time and will not be in a straight line, but obviously will then give us sort of individual discrete steps that we expect to see.

而且我們預期在生產力方面的重大提升，以及隨之而來的人力成本下降，將會在今年內發生。之後可能會有一些個別要素，我們會導入特定的技術改善，進而再次帶來階躍式的變化；但那些不會——顯然需要時間，也不會呈現直線式改善，而是會以我們預期可見的、離散的個別步階方式出現。

But for the time being, I think most of it is really just the actual improvement on the work hours and the impact of the changes in the operating model, which will likely have the single biggest contribution that will be made through that. And then there are a number of much smaller initiatives that over time will add to that.

但就目前而言，我認為大部分仍是工時的實質改善，以及營運模式變更所帶來的影響；這很可能會是最大的單一貢獻來源。此外，還有一些規模更小的計畫，會隨時間逐步累積貢獻。

And then with regards to the MS commercialization question. What we're seeing in MS is obviously a population of patients that obviously are much more -- first of all, it's a much larger population. They're much more distributed. But there also -- it's also a patient group that's extremely motivated, and we see that also even in the conduct of the clinical study, where we see even a different dynamic even to acute leukemia, where you know this is a disease that can actually quite likely may kill you, there's still actually a higher degree, I think, of dynamic that we're seeing with MS patients. So that is sort of one side of the equation.

接著談 MS 商業化的問題。我們在 MS 看到的顯然是一個患者族群：首先，這是一個更大的族群；患者分布也更分散。但同時——這也是一個動機非常強的患者群體；我們甚至在臨床試驗的執行中也看到了這一點，呈現出與急性白血病不同的動態。你知道，急性白血病是一種很可能會致命的疾病，但我們在 MS 患者身上看到的動態程度反而更高。我想這是方程式的一面。

But then there's a sheer volume question in terms of if you have some product that actually impacts these patients, it's a very substantial patient population. And so from that perspective, it does make sense to consider certainly a commercial approach where you would operate in collaboration with a partner, and that's certainly one of the areas that we're exploring.

但另一方面，還有一個純粹的量體問題：如果你有一個產品能夠影響這些患者，那將面對的是非常龐大的患者族群。因此，從這個角度來看，確實有理由考慮採取與合作夥伴協作的商業化方式，而這也正是我們正在探索的方向之一。

Thank you. And this concludes our Q&A session for today.

謝謝。今天的問答環節到此結束。

Very good.

很好。

Thank you so much.

非常感謝。

Thanks, everybody, and have a great Q2. I'm looking forward to keeping you updated at the various conferences during the quarter. Thank you.

謝謝各位，祝大家第二季順利。我期待在本季的各個會議上持續向各位更新進展。謝謝。

Thank you for participating in today's conference. This concludes the program, and you may now disconnect.

感謝您參與今天的電話會議。本次議程到此結束，您現在可以中斷連線。