Autolus Therapeutics PLC (AUTL) 2026 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Autolus Therapeutics second quarter 2026 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

各位好，感謝您耐心等候。歡迎參加 Autolus Therapeutics 2026 年第二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。

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

現在我想把會議交給今天的第一位講者，投資人關係執行董事 Amanda Cray。請開始。

Thank you, Dede. Good morning and 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，Dede。各位早安、午安，感謝大家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，我們將根據聯邦證券法以及 1995 年《私人證券訴訟改革法》(Private Securities Litigation Reform Act of 1995) 的安全港條款，發表與本公司業務相關的前瞻性陳述。

These may include, but are not limited to, statements regarding the status of 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 time lines and market opportunities for obe-cel and our other product candidates. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today.

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 對 AUCATZYL 的製造、銷售與行銷計畫、AUCATZYL 的市場潛力，以及 obe-cel 與我們其他產品候選藥物的臨床試驗狀態、開發及／或法規時程與市場機會。這些陳述受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。

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.

我們不承擔更新任何此類前瞻性陳述的義務。如需了解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美國證券交易委員會（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。如同往常，Christian 將先概述我們的營運重點。接著 Rob 將說明財務結果，最後 Christian 將以即將到來的里程碑與結語作結。之後我們將進行問答。

With that, I'm happy to turn it over to Christian.

接下來，我很高興把時間交給 Christian。

Thanks, Amanda, and welcome, everybody, to our second quarter call. We're moving to slide number 4. We had a very positive second quarter with strong AUCATZYL sales growth in this -- in our second year of launch now. When we look at the AUCATZYL revenue in the second quarter, we're at $45.7 million, which is a substantial increase over the $26 million that we had in the first quarter.

謝謝你，Amanda，也歡迎各位參加我們的第二季電話會議。我們翻到第 4 張投影片。第二季表現非常正面；在目前上市的第二年，我們的 AUCATZYL 銷售成長強勁。就第二季 AUCATZYL 營收而言，我們達到 4,570 萬美元，較第一季的 2,600 萬美元大幅增加。

For the first half of the year, we reached $71.9 million, which is close to the full year number that we had for our first year of launch last year. We see that the positive experience that the physicians are having with the product in the centers that we're active in, which is also reflected in the data that was collected by the ROCCA consortium and the real-world database that was presented at the TANDEM meeting. It builds a very strong foundation for the adoption of the product, and I think the continued positive momentum that we're seeing in the market.

上半年合計達到 7,190 萬美元，已接近我們去年第一個上市年度的全年數字。我們看到在我們已布局的治療中心中，醫師對產品的正面使用經驗；這也反映在 ROCCA 聯盟所蒐集的資料，以及於 TANDEM 會議上發表的真實世界資料庫數據中。這為產品的採用奠定了非常堅實的基礎，也延續了我們在市場上看到的正向動能。

We also obviously have continued to grow our presence from a center perspective. We had indicated at the beginning of the year that we would reach in the range of 80 centers for the full year. We're now at the midyear point, and we're above 80 centers already, and we continue to add centers in the second half of the year as well. When we look to the UK, we started the launch at the beginning of the year.

此外，我們也持續從治療中心的角度擴大布局。我們在年初曾表示，全年將達到約 80 家中心的範圍。目前來到年中，我們已經超過 80 家中心，且在下半年仍將持續新增中心。至於英國，我們在年初啟動上市。

We do see a strong initial adoption, and we obviously continue to also add treatment centers as we go through the remainder of the year. With that, we're going to move to slide number 5. I think we are on a very good path here and show very good momentum for the goals that we have set for ourselves for 2026. When we look at the net revenue projection that we had for the year that was originally set at $120 million to $135 million, we're now at a point where we can actually increase our guidance to $140 million to $150 million for the full year.

我們確實看到強勁的初期採用，同時也會在今年剩餘期間持續新增治療中心。接下來我們翻到第 5 張投影片。我認為我們目前走在非常好的軌道上，並展現出達成 2026 年自訂目標的良好動能。就我們原先對全年淨營收的預測（1.2 億至 1.35 億美元）而言，我們現在可以把全年財測上調至 1.4 億至 1.5 億美元。

The gross margin development, we've seen a very nice move as we're going from the first to the second quarter. The first quarter was just positive on the gross margin. We now made a very positive step in the second quarter, which is driven by increased volumes in terms of batches that we manufactured at our plant at the Nucleus in the UK, but also a lot of the improvements that we made on the operational -- the operations as well, both at the manufacturing side as well as the commercial side.

在毛利率的發展方面，我們看到從第一季到第二季有非常明顯的改善。第一季毛利率僅略為轉正。第二季我們邁出非常正面的步伐，主要受惠於我們在英國 Nucleus 廠區製造的批次量增加，同時也來自我們在營運面所做的多項改善——包括製造端與商業端。

All of that actually supports the gross margin development here. That obviously is a key driver towards the company moving towards profitability for this part of our business. When we look at the commercial expansion, we're now in more than 80 centers, as indicated. We continue to grow. We're particularly going to look at areas that may be underserved where distances to centers are still relatively wide or large.

上述因素共同支持了毛利率的改善。這顯然是推動公司在此業務板塊邁向獲利的關鍵驅動因素。就商業擴張而言，如前所述，我們已進入超過 80 家中心。我們仍在持續成長。我們特別會關注可能服務不足的地區，因為當地到治療中心的距離仍相對較遠。

And we want to make sure so that patients have adequate access and have centers within a reasonable -- within reasonable reach. As we're looking across the US, we do see that we actually have a very good distribution across the US, and we'll continue to add obviously, additional centers in some of the states where we may not be active yet at this point.

我們希望確保病患能有足夠的可近性，並在合理距離內就能找到治療中心。從美國整體來看，我們的布局分布其實相當良好；同時也會在一些目前尚未進入的州，持續新增治療中心。

Moving to slide number 6. I think as we're sort of moving through the ramp-up here on the launch, it was very important that we're obviously driving towards a very stable delivery of the product. And with that, over time, as we're improving our margins of the product, reach profitability for our business in the relapsed/refractory B-ALL indication.

接著翻到第 6 張投影片。在上市爬坡的過程中，確保產品交付非常穩定至關重要。因此，隨著時間推進，我們將在提升產品毛利率的同時，讓我們在復發／難治性 B-ALL 適應症的業務達到獲利。

When we look back into last year, the first objective was to really get us to a place where we have very robust, consistent high-quality product supply and services that we can provide to the centers. We achieved that within the first probably six to nine months during the course of the first year of launch last year. We then started to shift our focus on to starting to optimize the processes and really drive for efficiency as well as obviously increasing the volumes.

回顧去年，我們的第一個目標是讓我們達到能夠提供非常穩健、穩定且高品質的產品供應與服務給各治療中心的狀態。我們在去年第一個上市年度的前六到九個月內，大概就達成了這個目標。之後我們開始把重心轉向流程最佳化，並推動效率提升，同時也持續提高產量。

Together, those two parameters are really the key drivers to improve margins. And that's ultimately what gets us to a place where we expect to be in the not-too-distant future to get us to a place where our gross profit margin is going to reach somewhere in the range of 65% to 70% for the ALL business.

這兩個要素合在一起，正是提升毛利率的關鍵驅動因素。最終，這將在不久的將來把我們帶到一個我們預期的位置：在 ALL 業務上，毛利率可達到約 65% 至 70% 的區間。

Now when we look at the development of gross margins, we're still negative in the fourth quarter last year. We were just on the other side, on the positive side in the Q1 this year, and we now have a healthy step-up to a 55% gross margin in the second quarter. We obviously expect to continue to drive the improvements, the optimizations, the drive for efficiency, which obviously are key drivers for the company to reach profitability in this line of business.

現在就毛利率的發展來看，去年第四季我們仍為負值。今年第一季我們剛剛轉為正值，而第二季毛利率則健康地躍升至 55%。我們顯然預期將持續推動改善、最佳化與效率提升；這些都是公司在此業務線達成獲利的關鍵驅動因素。

Moving to slide number 7. I would like just to briefly summarize kind of where we are from a pipeline perspective. We see, obviously, a very strong foundation with obe-cel or AUCATZYL in the adult ALL setting. But it obviously also gives us a lot of opportunity in other B-cell-mediated diseases, both on the oncology but also the autoimmune side.

接著到第 7 張投影片。我想先簡要總結一下，從產品線（pipeline）的角度我們目前所處的位置。我們顯然在成人 ALL 適應症上，憑藉 obe-cel 或 AUCATZYL 建立了非常強勁的基礎。但這也明顯為我們在其他由 B 細胞介導的疾病上帶來許多機會，涵蓋腫瘤領域以及自體免疫領域。

As we're sort of going through the news flow that we're expecting for the upcoming periods, I would start out with kind of the key news flow that we're expecting for the end of this year, which is really focused first on the update for the CARLYSLE study at the ACR conference, which gives us an opportunity to really give us a longer-term view on the data and a clear understanding on the durability of the effect that we have seen in the systemic lupus patients.

在我們梳理未來一段時間預期的新聞流時，我會先從今年年底最關鍵的新聞流談起，重點首先是 ACR 年會上 CARLYSLE 研究的更新，這讓我們有機會以更長期的視角檢視數據，並清楚理解我們在系統性紅斑狼瘡患者中所觀察到療效的持久性。

We will then look into additional updates coming from the FELIX study, where we have a few additional analysis planned to be presented by the end of the year. And as we're going into the next product opportunity with AUTO8, which is a BCMA CD19-targeting product where we have an initial trial ongoing in light-chain amyloidosis, we expect initial data to become available by the end of the year as well.

接著我們也會關注 FELIX 研究的進一步更新，我們計畫在今年年底前發表幾項額外分析。此外，隨著我們推進下一個產品機會 AUTO8（一款同時靶向 BCMA 與 CD19 的產品），目前已在輕鏈型類澱粉沉積症進行初始試驗，我們也預期在今年年底前取得初步數據。

As we're sort of looking into the first part of 2027, the key focus there is going to be on the first data from our BOBCAT study in progressive multiple sclerosis patients. This will be the first data set out of that study. We expect a second data set to become available second half of next year, where we expect longer follow-up, more patients and longer follow-up in that indication.

展望 2027 年上半年，關鍵重點將是我們 BOBCAT 研究在進行性多發性硬化症患者中的首批數據。這將是該研究的第一組數據。我們預期在明年下半年會有第二組數據可用，屆時在該適應症中將有更長的追蹤時間、更多患者以及更長期的隨訪。

Both, obviously, important data points as we go through the course of next year. When we then look to the end of next year, we're at the point where we expect to have the first data coming from the pivotal study, the CATULUS study in pediatric ALL. That study is enrolling very well. We expect that study to actually be -- reach the end of enrollment by the end of the year. And then obviously, we're getting into the follow-up and then the workup of that data, hopefully, towards the filing by the end of next year, early 2028.

這兩者顯然都是我們在明年推進過程中的重要數據節點。再看向明年年底，我們預期將取得關鍵性試驗（pivotal study）——CATULUS 研究在兒科 ALL 的首批數據。該研究入組進展非常順利。我們預期該研究將在年底前完成入組。之後當然會進入隨訪與數據整理，並希望在明年年底、2028 年初朝申報（filing）邁進。

And then in -- when we look a little further out into 2028, we do expect then the Phase II data from the LUMINA study in patients with lupus nephritis. So there's quite a full set of data that we expect from the various studies going beyond the adult ALL opportunity, which we obviously continue to update you on as well.

再往後看至 2028 年，我們也預期將取得 LUMINA 研究在狼瘡腎炎患者中的第二期（Phase II）數據。因此，除了成人 ALL 的機會之外，我們也預期從多項研究中獲得相當完整的一系列數據；而成人 ALL 的進展我們也會持續向各位更新。

When we then look briefly on slide number 8, what to expect with regards to the BOBCAT study in progressive MS, we have in Q1 next year targeting the ACTRIMS meeting, which is obviously one of the key venues for MS data. We would, at that point, expect to have a total of 12 patients that we can report data from. We're going to look at safety at the PK/PD data, biomarker data and certainly early clinical experience.

接著簡要看第 8 張投影片，關於進行性 MS 的 BOBCAT 研究可期待的內容：我們計畫在明年第一季鎖定 ACTRIMS 會議，這顯然是 MS 數據的重要發表平台之一。屆時我們預期可報告合計 12 位患者的數據。我們將檢視安全性、PK/PD 數據、生物標誌物數據，當然也包括早期臨床經驗。

And then looking for the second half of next year with a total of expected 18 patients, we will then have an opportunity to look at clinical response, particularly with the longer-term follow-up. So we'll expect to have imaging data as well as expanding safety, PK/PD, biomarker data.

而在明年下半年，預計總計 18 位患者時，我們將有機會在更長期隨訪下評估臨床反應。因此我們也預期會有影像學數據，以及擴充的安全性、PK/PD 與生物標誌物數據。

And certainly, we'll, at that point, look at potential next steps for the program. So we believe that when we look at this opportunity in MS, obviously, the key clinical scores or EDSS scores, those obviously do contain elements that are either patient or physician-reported. And that is also why I would actually like to have about 12 months of follow-up for patients to understand that indeed, the response is a true reflection of the product activity, and we don't have an overlay of potential outcomes that are reported that might actually have a component that might be more placebo type of effect.

並且在那個時間點，我們也會評估該計畫可能的下一步。我們認為，在 MS 這個機會上，關鍵的臨床評分或 EDSS 分數，確實包含患者回報或醫師回報的要素。這也是為什麼我希望能有約 12 個月的患者隨訪，以確認觀察到的反應確實反映產品活性，而不是受到可能的回報偏差影響，其中可能包含較偏向安慰劑效應的成分。

So with that, I would like to actually move over to slide number 9 and hand over to Rob for the financial results.

因此，接下來我想轉到第 9 張投影片，並把財務結果交給 Rob。

Thanks, Christian, and good morning or good afternoon to everyone. I'm pleased to review our financial results for what was a strong second quarter of 2026, and I'll be referring to slide 10 in the presentation. Our total net product revenue for the second quarter of '26 was $45.7 million. That's compared with $20.9 million in the second quarter of 2025 or compared to $26.2 million in the first quarter of 2026. This quarter reflects sales in both the US and UK markets. While the UK market is showing strong adoption, it is still early in the launch and contribution from the UK was relatively minor when compared to the US.

謝謝你，Christian，也向各位道早安或午安。我很高興回顧我們在 2026 年第二季的財務結果，這是一個表現強勁的季度；我將參照簡報中的第 10 張投影片。我們 2026 年第二季的產品淨營收總額為 4,570 萬美元。相較之下，2025 年第二季為 2,090 萬美元，或相較 2026 年第一季的 2,620 萬美元。本季反映了美國與英國市場的銷售。雖然英國市場採用情況強勁，但上市仍屬早期，英國的貢獻相較美國仍相對較小。

As Christian noted, based on the recent performance, we've increased our net product revenue guidance, and we now expect full year AUCATZYL revenue of between $140 million and $150 million. We were also pleased to see further improvement in gross margin during the quarter to 55%, up from 6% in Q1 and negative in all prior quarters of 2025.

如 Christian 所提到，基於近期表現，我們已上調產品淨營收指引，現在預期 AUCATZYL 全年營收介於 1.40 億至 1.50 億美元。我們也很高興看到本季毛利率進一步改善至 55%，高於第一季的 6%，且優於 2025 年所有先前季度的負值。

The improvement was driven by a combination of increasing commercial production volume, operating model efficiency and cost reduction initiatives that we undertook beginning earlier this year. We also began for the first time, clinical production in our Nucleus facility in the second quarter, further improving our cost per batch economics. We expect gross margin to continue to improve towards a peak estimate of 65% to 70% in the adult ALL market.

這項改善來自多項因素的組合，包括商業化生產量提升、營運模式效率提升，以及我們自今年稍早開始推動的成本降低措施。我們也在第二季首次於 Nucleus 廠房啟動臨床用生產，進一步改善每批次成本經濟性。我們預期毛利率將持續改善，朝成人 ALL 市場的峰值估計 65% 至 70% 邁進。

Underlying the gross margin, our cost of sales in the second quarter totaled $20.5 million as compared to $24.4 million in the same period in 2025. The decrease was primarily driven by the improvements just mentioned as well as lower inventory reserves and write-offs in the quarter. Our research and development expense was roughly flat at $27.9 million for the second quarter of '26 compared to $27.4 million during the same period in '25.

在毛利率的基礎之下，我們第二季銷貨成本合計為 2,050 萬美元，相較 2025 年同期為 2,440 萬美元。下降主要來自前述改善因素，以及本季較低的存貨準備與沖銷。我們 2026 年第二季研發費用約為 2,790 萬美元，與 2025 年同期的 2,740 萬美元大致持平。

Selling, general and administrative expenses increased to $41.2 million for the second quarter of '26 compared to $30.3 million in the same period in 2025. The increase was primarily due to employment-related costs and professional fees supporting commercialization activities in both the US and UK. In addition, the quarter also includes certain onetime items such as termination-related expenses related to the strategic operational efficiency and cost reduction initiative that we announced back in April of this year.

2026 年第二季銷售、一般及行政費用增至 4,120 萬美元，相較 2025 年同期為 3,030 萬美元。增加主要是由於與僱用相關的成本，以及支援美國與英國商業化活動的專業服務費用。此外，本季亦包含若干一次性項目，例如與我們今年 4 月宣布的策略性營運效率與成本降低計畫相關的解約費用。

Our loss from operations for the second quarter was $43.8 million as compared to $61.2 million for the same period in '25. And finally, net loss was $39.1 million for the three months ending June 30, 2026, compared to $47.9 million for the same period in 2025. Last week, we announced that we entered into a strategic financing with Perceptive Advisors for the sale of notes of up to $250 million in aggregate principal amount as part of a five-year interest-only senior credit facility.

我們第二季營業損失為 4,380 萬美元，相較 2025 年同期為 6,120 萬美元。最後，截至 2026 年 6 月 30 日止三個月的淨損為 3,910 萬美元，相較 2025 年同期為 4,790 萬美元。上週我們宣布，已與 Perceptive Advisors 達成策略性融資安排，作為一項五年期、僅付利息的優先信貸融資的一部分，出售票據的本金總額最高可達 2.50 億美元。

As part of the transaction, an initial $75 million in principal amount was drawn at closing and an additional $25 million will be available at our option for up to six months post closing date. An additional $150 million of subsequent capital may become available in separate tranches upon achievement of certain prespecified revenue milestones.

作為該交易的一部分，我們在交割時提取了本金金額7,500萬美元的初始款項，並且在交割日起最多六個月內，另有2,500萬美元可由我們選擇是否動用。此外，若達成若干預先設定的營收里程碑，後續資本最多1.5億美元可能會以不同分期的方式另行提供。

This financing provides us with additional capital to support key inflection points for the business, including clinical data milestones in our oncology and autoimmune development programs that Christian just walked through. We'll have a meaningful opportunity to expand into new and larger markets, which we view as significant growth drivers and the potential additional tranches provide optionality and flexibility as we advance these pipeline programs.

這項融資為我們提供額外資本，以支持業務的關鍵拐點，包括Christian剛剛介紹過的腫瘤與自體免疫研發計畫中的臨床數據里程碑。我們將有重要機會擴展至新的且更大的市場；我們將其視為顯著的成長驅動因素，而潛在的額外分期也在我們推進這些管線計畫時提供選擇性與彈性。

Our cash, cash equivalents and marketable securities at June 30, 2026, totaled $201.6 million. This excludes the initial drawdown on the Perceptive credit facility, which closed in July. This balance, combined with the anticipated net revenues and the first and second tranches of the credit facility totaling $100 million, provides us with cash runway into the second quarter of 2028.

截至2026年6月30日，我們的現金、現金等價物及有價證券合計為2.016億美元。此數字不包含Perceptive信貸融資安排的初始提取款項，該安排已於7月完成交割。該餘額加上預期的淨營收，以及信貸融資安排第一與第二期合計1億美元，將使我們的現金可支撐至2028年第二季。

I'll now hand back to Christian to wrap things up with expected milestones and conclusions.

接下來我把時間交還給Christian，請他以預期里程碑與結論作收尾。

Thanks, Rob. We're moving to slide number 12 for the conclusion. We believe Autolus is well positioned for value creation. We have, on the one hand, the opportunities on the commercial AUCATZYL product in relapsed/refractory B-ALL patients on the adult population. We have shown very strong execution.

謝謝你，Rob。我們翻到第12張投影片作結論。我們相信Autolus具備良好的價值創造定位。一方面，我們在商業化產品AUCATZYL上，於成人復發/難治性B-ALL患者族群中擁有機會。我們已展現非常強的執行力。

We've seen a very positive market expansion, reached $71.9 million in net revenue for the first half of the year. This has allowed us to increase the guidance for the fiscal year 2026 to $140 million to $150 million in net product revenue. We believe there's a significant opportunity to grow the CAR T market share in this indication.

我們看到非常正向的市場擴張，上半年淨營收達到7,190萬美元。這使我們得以上調2026會計年度指引至淨產品營收1.4億至1.5億美元。我們相信在此適應症上，提升CAR T市場占有率有顯著機會。

And we're building on very strong physician interest, which is also, I think, exemplified by the interest to investigate obe-cel in the first-line setting in ALL in investigator-sponsored trials, which actually have already started, and we're looking forward to obviously seeing the results of those trials in the upcoming periods. When we then look in terms of the additional opportunities beyond the adult ALL population, we obviously have two pivotal studies ongoing.

我們也建立在醫師高度興趣之上；我認為這也體現在由研究者發起的試驗中，對於在ALL一線治療情境下研究obe-cel的興趣——這些試驗其實已經開始，我們也期待在接下來的期間看到其結果。此外，若從成人ALL族群以外的機會來看，我們目前顯然有兩項樞紐性研究正在進行。

We have the pediatric ALL study ongoing, the CATULUS study, which is expected to read out by the end of next year. And we have also the pivotal study, the LUMINA study in lupus nephritis ongoing, which is expected to deliver data in 2028. Finally, with the opportunity beyond the classical rheumatology indications in the lupus setting, we're also looking at the opportunity in progressive multiple sclerosis, which gives us, I think, a shot at potentially getting to a very substantial commercial opportunity beyond what we are currently targeting in the oncology setting. This program is ongoing in a Phase I study.

我們正在進行兒科ALL研究CATULUS，預計於明年年底讀出結果。我們也在進行狼瘡腎炎的樞紐性研究LUMINA，預計於2028年提供數據。最後，除了狼瘡領域的傳統風濕免疫適應症之外，我們也在評估進行性多發性硬化症的機會；我認為這讓我們有機會觸及一個非常可觀的商業機會，超越我們目前在腫瘤領域所鎖定的目標。該計畫目前正在第一期研究中進行。

It's the BOBCAT study. And as indicated, we expect to provide data updates during the course of 2027. With that, we believe we actually have a set of interesting data catalysts and updates during the course of 2027, which will set us up well for then the expected opportunity for a launch in pediatric ALL in 2028 and subsequent launches in 2029 on the lupus side.

這是BOBCAT研究。如先前所述，我們預期在2027年期間提供數據更新。因此，我們相信在2027年期間將有一系列有趣的數據催化劑與更新，為我們在2028年於兒科ALL的預期上市機會奠定良好基礎，並在2029年於狼瘡領域進行後續上市。

When we look in terms of the overall setup of the company, obviously, the foundation that we built is a very strong foundation, both from a manufacturing and from a commercial capability perspective. And obviously, having now experience in more than 80 centers, authorized treatment centers across the US and approaching 20 authorized treatment centers also in the UK, which provides a very strong foundation for all the new indications that we're also planning and are developing here as well.

從公司的整體布局來看，我們所建立的基礎顯然非常扎實，無論在製造端或商業化能力方面皆是如此。此外，我們目前已在美國超過80家中心（授權治療中心）累積經驗，英國也接近20家授權治療中心，這為我們規劃與開發中的所有新適應症提供非常強的基礎。

So with that, I'd like to actually conclude and open up for questions.

因此，我想在此作結並開放提問。

(Operator Instructions)

（接線員指示）

Salim Syed, Mizuho.

Salim Syed，瑞穗（Mizuho）。

Congrats on the progress. Just one from us on the guide. So Christian, Rob, when you look at the high end of the guide, it would imply a slight decline versus the 2Q $45 million revenue. Is that just conservatism on your part? Or are you expecting some sort of seasonality or other one-timers to affect the 3Q and 4Q revenue?

恭喜你們的進展。我們只有一個關於指引的問題。Christian、Rob，若看指引的高端，意味著相較於第二季4,500萬美元營收會略有下滑。這只是你們較為保守嗎？還是你們預期會有某種季節性或其他一次性因素影響第三季與第四季營收？

Very good question. So when we look at the -- obviously, the first half of the year, we see obviously a pretty significant step-up in Q2. We believe that is in part driven by the positive data that was reported from the real-world experience at the TANDEM meeting and certainly did drive a very significant increase in registrations onto the program in the second half of the first quarter.

非常好的問題。當我們看——顯然，上半年我們看到第二季有相當顯著的躍升。我們認為這部分是由TANDEM會議上所報告的真實世界經驗正向數據所帶動，並且確實在第一季下半段推動了加入該計畫的註冊量大幅增加。

And those -- obviously, those patients obviously were driving to quite an extent, I think, the very positive outcome we've seen in Q2. So we think that creates a very good foundation for the rest of the year. There is certainly going to be elements of seasonality that we would expect during the course of the year.

而這些——顯然，這些患者在很大程度上推動了我們在第二季看到的非常正向成果。因此我們認為，這為今年剩餘期間奠定了非常好的基礎。在一年當中，我們確實預期會存在一些季節性因素。

And so given that, certainly, we've seen that to some extent last year. It is an element that we're considering. And we believe that the guidance that we're providing is reasonable and certainly has an element of prudence as well.

因此，基於這點，我們去年確實在某種程度上也看到了這種情況。這是我們正在納入考量的因素之一。我們相信所提供的指引是合理的，並且也包含一定程度的審慎。

Matt Phipps, William Blair.

Matt Phipps，William Blair。

This is Madeleine on for Matt Phipps. On gross margins, could you provide any color on how we should think about the trajectory for the rest of the year and maybe comment on potential timing to achieve that target of 65% to 70%, given we're at 55% now?

我是Madeleine，代替Matt Phipps提問。關於毛利率，能否提供一些看法，讓我們理解今年剩餘期間的走勢？另外，鑑於目前為55%，也請評論一下達成65%至70%目標的可能時間點？

Thanks, Madeleine. Obviously, a very good question. It's an area of significant focus from our side. Elements that obviously contributed to this substantial step-up in gross margin in the second quarter were, on the one hand, obviously, the number of batches that were manufactured through that period. Obviously an increase, as you could see on the commercial side, but we also did actually consolidate our clinical trial manufacturing into the Nucleus.

謝謝你，Madeleine。顯然是個非常好的問題。這是我們高度聚焦的領域。第二季毛利率大幅提升的因素之一，顯然是該期間製造的批次數量。商業端如你所見有所增加，同時我們也確實將臨床試驗製造整合至Nucleus。

So there is a larger amount of volume that we pushed through both on the commercial as well as the clinical side. That obviously helps a lot in terms of the key base cost that we have in the operation, the fixed cost within the operation and obviously allows us to sort of actually get to a broader number of batches that can support that.

因此，無論在商業端或臨床端，我們都推進了更大的產量。這在我們營運中的關鍵基礎成本方面帶來很大幫助，也就是營運中的固定成本，並且顯然讓我們能夠擴大可支撐的批次數。

In addition, we've been very active on reviewing our entire operating model and looked at every aspect along the manufacturing process to ensure that we actually gain efficiency in the entirety of the manufacturing process, both production as well as product release. Those activities will continue, but we've made some significant changes during the course of the second quarter that we expect to actually have beneficial impact as we continue the rest of the year.

此外，我們也非常積極地檢視整體營運模式，並審視製造流程中的每一個環節，以確保我們在整個製造流程中（包含生產以及產品放行）都能提升效率。這些工作將持續進行；不過我們在第二季期間已做出一些重大調整，預期在今年剩餘期間持續帶來正面影響。

So those are kind of the key areas that actually impact and actually did drive this very positive development that we've seen. We're guiding to 65% to 70% for kind of the more mature ALL business, which we expect to reach somewhere in the range of about 12 to 18 months. That's kind of the ballpark that we're currently seeing in terms of development. And those we will continue to update you on that, but obviously, an important step that we've taken now and which allows us to actually build a very strong foundation for the business.

所以，這些算是實際上會產生影響、也確實推動我們所看到這項非常正向進展的關鍵領域。對於較成熟的 ALL 業務，我們的指引是 65% 到 70%，我們預期大約在 12 到 18 個月內可達到該水準。這大致就是我們目前在發展上所看到的區間。我們也會持續向各位更新；但顯然，我們現在所採取的一個重要步驟，讓我們得以為業務建立非常堅實的基礎。

Yanan Zhu, Wells Fargo.

Yanan Zhu，富國銀行。

Congrats on a great quarter. So on the sales side, I was just wondering about your confidence about the next quarter or two, given what you -- what visibility you might have into the third quarter. What's the confidence for another quarter with strong sales, given that you have this 74% jump from the first quarter to the second quarter.

恭喜本季表現亮眼。在銷售面，我想請教你們對下一季或接下來兩季的信心如何，考量到你們——你們對第三季可能掌握的能見度。在第一季到第二季銷售跳增 74% 的情況下，對於再出現一季強勁銷售的信心如何？

So the main question is ability to maintain continued sales at the new foundation, similar, I guess, along the lines of a prior question. And if you can comment on market share within the CAR T category and whether you are -- whether the growth is from switching patients or taking share or growing the market in a way?

所以主要問題是：是否有能力在新的基礎水準上維持持續的銷售，類似於我想先前一個問題的方向。另外，若可以的話，請評論一下在 CAR T 類別中的市占情況，以及成長是否來自病患轉換、搶占份額，或是以某種方式擴大市場？

Yes, Yanan, thanks for joining. I think when we look at the kind of future growth, I think this is very much growing the overall CAR T market share is kind of the key area of focus for us. And so that's sort of where really most of the drive is to sort of make sure that, that's kind of where we're headed with the product.

是的，Yanan，謝謝你加入。我想當我們看未來成長時，對我們而言，關鍵的聚焦領域非常在於推動整體 CAR T 市場的市占提升。因此，主要的驅動力就是確保我們的產品朝這個方向前進。

We see -- I think most of the dynamic we've seen so far has been both obviously, within kind of the patient pool that already had prior access to CAR T, but it also included also patients that were kind of somewhat outside of the group of patients that were considered to be suitable for CAR T therapy.

我們看到——我認為目前為止我們看到的大部分動態，顯然一方面來自原本就已經能取得 CAR T 的病患族群，但同時也包含一些原本略微不在、或不被認為適合接受 CAR T 治療的病患。

And that's already visible in the data that was presented by the ROCCA consortium at TANDEM when you look at the patient composition. So I think we're seeing a very positive dynamic. I think we have good -- we see good continued activity and demand. We expect that obviously to continue for the rest of the year and then continue to build momentum in 2027.

當你看 ROCCA 聯盟在 TANDEM 上所呈現的數據、並觀察病患組成時，這點已經在資料中可見。所以我認為我們看到非常正向的動態。我認為我們有良好——我們看到持續良好的活動與需求。我們預期這種情況顯然會在今年剩餘時間持續，並在 2027 年繼續累積動能。

So we're, I think, in a very good place there. As Salim asked before, there's going to -- probably going to be some elements of fluctuations that we may see between the quarters, but we're very confident with the guidance we're giving for the full year, and I think we're very optimistic for 2027 as well.

所以我認為我們目前處於非常好的位置。如同 Salim 先前問到的，季度之間可能——可能會出現一些波動因素，但我們對全年所給出的指引非常有信心，也對 2027 年非常樂觀。

Gil Blum, Needham & Company.

Gil Blum，Needham & Company。

Also, I'd like to add my congratulations on a very strong quarter. Just a couple of quick ones from us. As it relates to the updated sCR for lupus nephritis, we're assuming it's the same number of patients just with longer follow-up, if you have any additional color to give there? And as a follow-up, you guys are already at 82 centers and you're thinking about 80 centers by year-end. How should we think about how many centers you may have by year-end?

我也想補充，恭喜你們本季表現非常強勁。我們這邊有幾個簡短問題。關於狼瘡腎炎更新後的 sCR，我們假設是同一批病患、只是追蹤時間更長；你們是否能提供更多說明？另外作為追問，你們已經到 82 個中心，且你們原本想在年底達到 80 個中心。我們應該如何看待你們到年底可能會有多少中心？

Thanks, Gil. Really appreciate the question. With regards to the CARLYSLE study, obviously, we're going to have a substantial portion of the patients that will have 12 months and longer follow-up, which we believe is going to be very meaningful and give us a real sense for the quality of the reset that I think we've seen early evidence for in our last data update for the CARLYSLE study.

謝謝，Gil。非常感謝這個問題。就 CARLYSLE 研究而言，顯然會有相當一部分病患具備 12 個月及更長期的追蹤，我們相信這將非常有意義，並讓我們真正了解我們在上一次 CARLYSLE 研究數據更新中已看到早期證據的那種「重置」品質。

But this obviously gives us substantially longer view on those patients and believe that this is actually going to be there. So I think very helpful to understand sort of the magnitude of the clinical benefit that we may be able to induce in the severe lupus patients.

但這顯然讓我們能以更長的時間視角來觀察這些病患，我們相信這確實會呈現出來。因此我認為，這將非常有助於理解我們可能在重度狼瘡病患中誘發的臨床效益幅度。

So that's going to be, I think, the key focus is really the longer-term follow-up and the impact on the clinical outcomes. With regards to the centers, as you rightly pointed out, we kind of hit the goal midyear of being at 80 centers or above. I would assume we're going to be at the 90-plus centers by the end of the year. And obviously, that gives us a very good reach, and I think will allow us to make sure that the product is properly accessible across the entirety of the US. And so this is really kind of one of the key areas we'll continue to work on.

所以我認為關鍵焦點會是更長期的追蹤，以及其對臨床結果的影響。至於中心數，如你所指出的，我們在年中就達成了 80 個中心或以上的目標。我預期到年底我們會達到 90 個以上的中心。而這顯然讓我們的覆蓋範圍非常好，也將使我們能確保產品在全美各地都能適當取得。因此，這確實是我們將持續努力的關鍵領域之一。

Simon Baker, Rothschild & Company.

Simon Baker，Rothschild & Company。

Two quick ones, if I may, please. I wonder if you could give us any help on OpEx run rate. It seems that we've had a fairly similar performance in the last two quarters on SG&A. R&D has fluctuated a little bit. I'm just wondering how Q2 or H1 works for those two cost lines as an indicator for the second half?

如果可以的話，我有兩個簡短問題。想請問你們是否能就營運費用（OpEx）的運行水準（run rate）提供一些協助。看起來過去兩季在 SG&A 的表現相當類似。R&D 則有些波動。我想了解 Q2 或上半年在這兩條成本線上，對下半年而言可作為何種指標？

And then secondly, on -- a question on capacity. The guidance for this year implies probably about 300 patients treated. Given the -- given that volume and given the clinical trial material, which will obviously only increase going forward, I just wonder if you could give us an update on where we are for capacity at Nucleus as it stands. And we know it's a very modular facility, how that can evolve over the coming years?

第二個是——關於產能的問題。今年的指引大概意味著約 300 位病患接受治療。考量到該量體，以及臨床試驗用料（其需求顯然只會在未來增加），我想請你們更新一下目前 Nucleus 的產能狀況。我們知道這是一個高度模組化的設施，未來幾年它將如何演進？

Thanks, Simon. Very good question. I'll start with the capacity question and then hand over for the OpEx question to Rob. On the capacity side, we're very well set up from a capacity perspective. We have an ability, we believe, at this point to fully serve the ALL market with our current setup and our current -- which is both the actual physical setup as well as from an operator and process perspective.

謝謝，Simon。非常好的問題。我先回答產能問題，然後把 OpEx 的問題交給 Rob。在產能方面，從產能角度來看我們準備得非常充分。以目前的配置——包括實體設施配置，以及操作人力與流程面——我們相信此刻已具備完全服務 ALL 市場的能力。

So we're very well set up from a capacity perspective. And we have an ability to obviously take on license additional clean rooms and as we're getting ready to really substantially increase beyond the ALL, which includes both adults and peds where we're very well set up today. Going beyond, obviously, we can mobilize additional clean rooms at the facility.

所以從產能角度來看，我們的準備非常充分。而且我們顯然也有能力再承租（license）額外的無塵室；當我們準備在 ALL 之外大幅擴張時——ALL 包含成人與兒科，我們今天在這方面已經準備得很完善——再往外擴張時，我們可以在該設施動員更多無塵室。超出部分，顯然我們可以在設施內動員額外的無塵室。

You don't want to do that too early because at that point, it would actually increase your overall cost of goods, which you don't want to do because your operating costs go up with more capacity than in that case might be idle and not properly used. But we have adequate levels of capacity we can mobilize beyond where we're currently set up. But for -- from an ALL perspective, we're fully set up for both adults and pediatrics in the territories we're active in and can actually very well manage that.

你不會想太早這麼做，因為那樣會提高整體銷貨成本（cost of goods），而你不希望如此；因為當產能增加但可能閒置、未被妥善利用時，你的營運成本會上升。但我們確實有足夠的產能水準，可以在目前配置之外再動員。不過就 ALL 而言，在我們目前活躍的地區，我們對成人與兒科都已完全就緒，並且能夠很好地加以管理。

But it also gives you a good sense for the level of improvements we're expecting to see. And with that, obviously, what's ultimately going to drive as we're increasing the number of batches through the facility, will actually how this is going to help us drive down the overall cost per batch, but also increase, obviously, the margins overall for the products. With that, I think we're headed over to the OpEx question, and I think this is one for you, Rob.

但這也讓你對我們預期將看到的改善幅度有一個很好的概念。而且，顯然，最終在我們提高工廠內每期（batch）產出數量的同時，真正會驅動的，是這將如何幫助我們降低每期的整體成本，同時也會提升產品的整體毛利率。基於此，我想我們接下來要轉到營運費用（OpEx）的問題，我想這題應該由你來回答，Rob。

Yes. Thanks for the question, Simon. I'll give you maybe a little bit more color. When you think about our R&D line, it's been -- if you look at last year, even it's probably on average of kind of mid- to high $20 million per quarter. What you'll see here is some variability around clinical production and when that actually hits in terms of the actual quarter of production and delivery to the sites.

是的。謝謝你的問題，Simon。我可以再補充一些細節。談到我們的研發（R&D）費用線，如果你看去年，平均大概每季在2,000多萬美元中段到高段的水準。你在這裡會看到一些波動，主要與臨床生產以及其在實際生產季度、並交付到各試驗中心的時間點有關。

You saw a step-up from Q1 to Q2 this year that was largely driven by kind of enrollment in studies more than anything in some of the clinical production. This associated with that, it's kind of like a onetime event within the study itself. But other than that, I think it's fair to say that we're not expecting any other kind of significant ramp-up or decrease. We're in the middle of executing a lot of this next wave of studies that Christian's kind of walked through.

你看到今年從第一季到第二季有一個上升，這主要是由研究入組（enrollment）所驅動，甚至比部分臨床生產的影響更大。與此相關的支出，在研究本身中有點像一次性事件。但除此之外，我認為可以合理地說，我們不預期還會有其他顯著的上升或下降。我們正處於執行下一波研究的中段，Christian 先前也已大致說明過。

On the SG&A line, the one thing I would call out is predominantly in the first quarter and second quarter of this year, we also were taking some of these onetime charges associated with the restructuring that we announced back in April. So that is incorporated on this line for the total company. Again, if you look to kind of exit last year, we were in kind of a mid- to high 30 range.

在銷售、一般及行政（SG&A）費用線方面，我想特別指出的是，今年第一季和第二季我們也認列了一些與我們在4月宣布的重組相關的一次性費用。因此，這些已納入公司整體的這條費用線中。同樣地，如果你回看去年年底的水準，我們大概是在3,000多萬美元中段到高段的區間。

And so when you kind of adjust for some of those things, we're kind of still in that ballpark with some very typical kind of year-over-year inflation increases and those kind of things. But fairly stable from that standpoint. Again, we're not expecting any significant kind of ramp-up for decrease other than some of those onetime items, which are largely behind us now with the second quarter.

因此，當你把其中一些因素調整掉後，我們大致仍在那個區間，只是會有一些很典型的年對年通膨增幅等因素。但從這個角度來看相當穩定。再次強調，除了那些一次性項目之外，我們不預期會有任何顯著的上升或下降；而這些一次性項目在第二季之後基本上已經告一段落。

Sebastiaan van der Schoot, Kempen.

Sebastiaan van der Schoot，Kempen。

Congrats on the excellent quarter. I was wondering whether you could provide some insights into those 80 activated sites. How many of those have actually already treated and have had experience with AUCATZYL? And do you see an acceleration of the time between activation and first patient treatment?

恭喜這個非常出色的季度表現。我想請問你們是否能就那80個已啟用（activated）的中心提供一些洞見。其中有多少已經實際治療過病人，並且有使用 AUCATZYL 的經驗？另外，你們是否看到從中心啟用到第一位病人接受治療之間的時間正在加速縮短？

And then regarding the capacity, you're also evaluating an automated system. When would you implement such a system? Is it already in the -- for adult ALL indication? Or would that only be if you also get approvals in autoimmune?

另外，關於產能，你們也在評估一套自動化系統。你們會在什麼時候導入這樣的系統？它是否已經納入成人 ALL 適應症的規劃之中？還是只有在你們也取得自體免疫適應症核准時才會導入？

Thanks for that, Seb. With regards to the 80 sites, the majority -- vast majority of them actually have already treated a patient. So we do see that actually that transition from getting activated and actually treating patients tends to be fairly quick. Quite often, actually, the activation is sort of motivated by one or two patients that are suitable for CAR T therapy at the center.

謝謝你的問題，Seb。關於這80個中心，絕大多數——非常大多數——其實都已經治療過病人。因此我們確實看到，從中心完成啟用到實際開始治療病人的轉換通常相當快。很多時候，啟用本身是因為該中心有一到兩位適合接受 CAR T 治療的病人而促成的。

And that's really driving the process and obviously, I think is a key part of the motivation also for centers to get authorized and to get online. So we're seeing a very positive dynamic there. And obviously, depending on the level of familiarity with obe-cel, most of the centers, obviously, that we now actually are adding are -- have not been part of clinical trials with obe-cel before.

這確實在推動整個流程，而且我認為這也是中心願意取得授權並上線的一個關鍵動機。所以我們看到非常正向的動態。當然，依據對 obe-cel 的熟悉程度而定，我們目前新增的大多數中心——顯然——先前並未參與 obe-cel 的臨床試驗。

So that obviously is going to be then the first time that we're going to be using the product. So that is certainly, I think, the dynamic that we're seeing at the stage that we're at. Obviously, early on, we had a lot of centers that already had experience, and we basically had always a seamless roll forward in terms of the experience from the development to the commercial side.

因此，這顯然會是他們第一次使用這個產品。我認為這確實就是我們在目前階段所看到的動態。當然，在早期，我們有很多中心本來就有相關經驗，因此在從研發到商業化的轉換上基本上是無縫銜接。

Now most of the centers we're adding on are centers that actually where obe-cel is going to be probably a new product that hasn't been actually used at the center before. And that also, obviously, certainly, as the centers start building, doesn't lead to an acceleration, but a pretty steady pace that we're seeing across these centers from here on forward. That's sort of the expectation.

現在我們新增的大多數中心，都是 obe-cel 可能是全新產品、先前未在該中心使用過的中心。而且，顯然，當這些中心開始建立量能時，這不會帶來加速，而是我們從現在起在各中心看到的相當穩定的推進速度。這就是我們的預期。

With regards to the capacity question, obviously, as I indicated before to Simon, we're very well set up. Our manufacturing process is actually to quite a significant extent already automated. We're going to expect to do another significant change on our current platform probably over the next 12 to 15 months, which will get us to a very, very high level of automation on the system.

關於產能問題，正如我先前對 Simon 所提到的，我們的準備非常充分。我們的製造流程其實在相當大的程度上已經自動化。我們預期在未來12到15個月內，會在現有平台上再進行一次重大的變更，這將使系統的自動化程度提升到非常、非常高的水準。

And then obviously, we're looking at additional technology for future opportunities. But in terms of the ALL setup, we're very well set up. And we're basically getting a lot of the gains out of the operational improvements that we're doing in the facility, not just on the actual manufacturing process, but the entirety of the whole chain of events that from the input into the facility, products coming in to all processes through testing, through release and then obviously the products reaching or being sent back to the treatment centers.

然後，當然，我們也在為未來的機會評估額外的技術。但就 ALL 的配置而言，我們已經準備得非常充分。而且我們正從在廠內所做的營運改善中獲得大量效益，不僅是在實際製造流程本身，也涵蓋整個事件鏈：從原料/產品進入廠區、到所有製程、到檢測、到放行（release），再到產品送回治療中心、抵達治療中心。

Every one of those steps actually is currently being evaluated, and we're working on improvements and efficiency gains. It's been quite significant progress that we've already been able to actually realize and build into the operation at this point in time.

上述每一個步驟目前都在評估中，我們也正在推動改善與效率提升。到目前為止，我們已經能夠實際實現並納入營運中的進展相當顯著。

Rajan Sharma, Goldman Sachs.

Rajan Sharma，高盛（Goldman Sachs）。

I realize it's early, but just could you help us understand what the UK, contribution was to AUCATZYL revenues in the quarter and what the initial feedback has been on the launch there? And perhaps if you could just help us understand also how we should think about contribution for the remainder of the year and where you are in terms of center activation.

我知道現在還早，但你們能否協助我們了解本季英國對 AUCATZYL 營收的貢獻是多少，以及當地上市初期的回饋如何？另外，也請協助我們理解，今年剩餘期間的貢獻應該如何看待，以及你們在中心啟用方面目前進展到哪個階段。

Yes. Thanks a lot, Rajan. Really good question. So when we look, obviously, at the UK, the UK has about, give or take, 60 million people, which is about 1/6 of the US population. So I think that's a ratio, I think, that sort of gets to sort of what's the potential ultimately and what's the ultimate patient numbers that you're going to have. There's certainly going to be about that ratio in terms of differential that we're going to expect.

是的。非常感謝你，Rajan。這是個很好的問題。我們來看英國的話，英國人口大約6,000萬左右，約為美國人口的六分之一。因此我認為這個比例大致可以用來理解最終的潛在規模，以及你最終可能看到的病人數量。我們確實預期在差異上大致會是這樣的比例。

We are -- we do see a very positive initial momentum. Obviously, we've been active in a substantial number of clinical trials over the years in the UK. So there's an element of familiarity with the product across a number of the academic centers. And we now obviously have activated already a good number of them. We expect to be at around 20 or so by the end of the year.

我們——我們確實看到非常正面的初期動能。顯然，過去多年我們在英國參與了相當多的臨床試驗。因此，在多個學術中心之間，對該產品存在一定程度的熟悉度。而且我們現在顯然已經啟動了其中相當多的中心。我們預期到年底大約會達到20個左右。

And that gives us, we believe, a good footprint across the UK. Now at this point, when we talk about the UK, we're really talking about predominantly the England. We're in the process of market access in Scotland. That will obviously then expand to the full size of the UK as well. So there is -- we're in, I think, on very good footing there.

我們認為，這讓我們在英國建立了良好的據點覆蓋。目前當我們談到英國時，實際上主要指的是英格蘭。我們正在推進蘇格蘭的市場准入流程。之後顯然也會擴展到整個英國的完整規模。所以我認為——我們在那裡的基礎非常穩固。

We have very good momentum. And we do expect that, that will actually continue going forward for the second half of the year. So from, I think, an initial, I think, perspective, we do believe that we actually have seen very nice momentum.

我們的動能非常好。而且我們確實預期，這種態勢在下半年會持續延續。因此，從初期的角度來看，我們確實相信我們已經看到非常不錯的動能。

But given the difference in just the population size, we're looking at substantially less than 10% of US sales that we're sort of seeing at this point in time. So that eventually, I think we'll sort of probably get beyond that. But it's an early part of the launch, and we just have completed the second quarter of the launch in the UK.

但考量到人口規模的差異，我們目前看到的銷售額大幅低於美國銷售額的10%。因此我認為，最終我們可能會超過那個水準。但這仍是上市初期，我們也才剛完成在英國上市的第二個季度。

Emily Bodnar, H.C. Wainwright.

Emily Bodnar，H.C. Wainwright。

Congrats on the quarter as well. Maybe can you frame the ALARIC readout for us by year-end and what you're kind of looking to see response rate-wise versus BCMA CAR T to maybe want to move this program forward?

也恭喜本季表現。或許您能幫我們說明一下年底前的 ALARIC 讀出，以及就反應率而言，您希望看到相較於 BCMA CAR T 的表現如何，才會想推進這個計畫？

Thanks, Emily. On the ALARIC study, this is a study we're conducting with our colleagues at UCL. And we are evaluating, obviously, the use of the BCMA program here in the light-chain amyloidosis setting. What we're interested in is to see obviously a good level of activity, a good safety profile, which is important in these patients and sort of with that, I think, build the foundation for the program.

謝謝，Emily。關於 ALARIC 研究，這是我們與 UCL 的同仁共同進行的一項研究。我們正在評估，顯然是在輕鏈類澱粉沉積症（light-chain amyloidosis）的情境下使用 BCMA 計畫。我們關注的是，顯然要看到良好的活性水準，以及良好的安全性概況——這對這些病人很重要——並以此為該計畫建立基礎。

I think at this point, it's probably too early to guide on how we might want to consider taking the program forward. We're in this Phase I study, which is not complete at this point. This is the first data set coming out of the study, and certainly a bit premature to sort of actually get a good feel for how the program might stack up.

我認為目前要指引我們可能會如何考慮推進這個計畫，可能還太早。我們正處於這項第一期研究中，而目前尚未完成。這是該研究首次釋出的資料集，現在要真正對這個計畫可能的競爭力形成清晰判斷，確實還有點言之過早。

I think it's worthwhile keeping in mind that the activity that you expect in this indication is very high, and it's probably not going to be straightforward to actually look at differentiation based on response rates in this indication, certainly not in small patient numbers. But I think we're going to see a very solid response rate in these patients and a good safety profile. I think those are the two hallmarks and the two pieces of information we're looking for.

值得記住的是，在這個適應症中你所期待的活性非常高，因此要僅以反應率來看差異化並不容易——至少在這個適應症中、尤其在病人數不多的情況下更是如此。但我認為，我們會在這些病人身上看到非常扎實的反應率以及良好的安全性概況。我認為這兩點就是我們在尋找的兩個標誌性特徵，也是我們要的兩項資訊。

Roger Song, Jefferies.

Roger Song，Jefferies。

This is Fiona on for Roger. Congrats on an amazing quarter. Just following up on the question regarding the activated centers and physician adoption. Can you comment on the utilization and repeat behavior from physicians among the centers that is more active or you have more visibility into? Is it more concentrated in certain centers? Or is it more widely distributed? And I'll hop back in the queue.

我是 Fiona，代 Roger 提問。恭喜你們有一個非常出色的季度。我想延續剛才關於已啟動中心與醫師採用的問題。你們能否評論一下，在那些更活躍或你們掌握較多資訊的中心中，醫師的使用情況與重複使用行為？是否更集中在某些中心？還是分布更為廣泛？我會回到隊列中。

Thanks a lot, Fiona. So when we look at the centers that we've been active in for a longer period of time now, we do see a very positive adoption across those centers. They do report the patients slightly differently depending on the center. So you might actually have centers that report predominantly through one name, but actually what you -- what's happening behind that name is actually the broader team that's actually utilizing the product and actually employing it.

非常感謝，Fiona。因此，當我們看那些我們已經運作較長一段時間的中心時，我們確實看到在這些中心之間非常正面的採用情況。各中心回報病人的方式會因中心而略有不同。因此你可能會看到某些中心主要以一個名稱來回報，但實際上——在那個名稱背後發生的是更廣泛的團隊正在使用並施用該產品。

Other centers actually report on the individual physician basis, and we have better visibility. So we see -- but in general, we see a very nice level of adoption across, obviously, all the CAR T users at the centers. And one of the key things that we're obviously looking at and we're certainly working on is to see that we can expand ultimately the number of CAR T users in those centers to really get a much broader adoption in each one of the centers. That's one dimension. The other dimension that we're certainly looking at very carefully is, obviously, the referral patterns into the centers and obviously to look for ways to support the referrals into the centers as well.

其他中心則會以個別醫師為基礎來回報，我們的可視性更高。所以我們看到——但總體而言，我們確實看到在各中心中，顯然所有 CAR T 使用者對產品的採用程度都相當不錯。而我們顯然正在關注、也確實在努力的一個關鍵點，是最終能擴大這些中心內 CAR T 使用者的人數，讓每個中心都能達到更廣泛的採用。這是一個面向。另一個我們也非常仔細在看的面向，顯然是轉診進入這些中心的模式，並尋找方法來支持轉診進入中心。

Thank you. I'm showing no further questions at this time. I'd like to turn it back to Christian Itin for closing remarks.

謝謝。目前顯示沒有其他問題。我想把時間交回給 Christian Itin 作結語。

Well, thank you very much for joining us for our Q2 update. Obviously, a very positive quarter, a lot of good momentum, and we're looking forward to keeping you updated and talk to you at the latest at our next quarterly update, but most likely meet in between. Thank you very much, and have a great day.

非常感謝各位參加我們的第二季更新。顯然這是一個非常正面的季度，動能良好；我們也期待持續向各位更新，並最晚在下一次季度更新時與各位交流，但更可能在此之前就會再見面。非常感謝，祝各位有美好的一天。

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

今天的電話會議到此結束。感謝各位參與，現在可以掛線。