2Seventy Bio Inc (TSVT) 2023 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the 2seventy bio Second Quarter 2023 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jenn Snyder, Head of Corporate Affairs. Please go ahead.

美好的一天，感謝您的支持。歡迎參加 2seventy bio 2023 年第二季財報電話會議。 （操作員指示）請注意，今天的會議正在錄製中。現在我想將會議交給今天的發言人、公司事務主管 Jenn Snyder。請繼續。

Thank you, operator. This morning, 2seventy bio issued a press release providing a business update in addition to second quarter 2023 financial results. The press release can be found in the Investors & Media section of the company's website at 2seventybio.com. Speaking on the call today are Nick Leschly, Chief Kairos Officer; Chip Baird, Chief Financial Officer; and Steve Bernstein, Chief Medical Officer. Philip Gregory, Chief Scientific Officer, is also on the line for the Q&A section.

謝謝你，接線生。今天上午，2seventy bio 發布了一份新聞稿，除了 2023 年第二季財務業績外，還提供了業務更新。新聞稿可在本公司網站 2seventybio.com 的投資者與媒體部分找到。 Kairos 首席官員 Nick Leschly 在今天的電話會議上發言。奇普·貝爾德，財務長；和首席醫療官史蒂夫伯恩斯坦。首席科學官 Philip Gregory 也參與了問答部分。

As a reminder, today's discussion will include forward-looking statements related to 2seventy bio's current plans and expectations, which are subject to certain risks and uncertainties. These forward-looking statements include statements regarding our strategic plans, time lines and expectations and statements regarding our financial condition, expectations and other future financial results, among others. Actual results may differ materially due to various risks, uncertainties and other factors, including those described in the Risk Factors section of our most recent Form 10-K and other SEC filings.

提醒一下，今天的討論將包括與 2seventy bio 當前計劃和預期相關的前瞻性陳述，這些陳述受到某些風險和不確定性的影響。這些前瞻性陳述包括有關我們的策略計劃、時間表和預期的陳述，以及有關我們的財務狀況、預期和其他未來財務表現的陳述等。由於各種風險、不確定性和其他因素，包括我們最新的 10-K 表格和其他 SEC 文件的風險因素部分中描述的因素，實際結果可能會存在重大差異。

These forward-looking statements represent our views as of this call and should not be relied upon us representing our views as of any subsequent date. You are cautioned not to place any undue reliance on these forward-looking statements, and except as required by law, we undertake no obligation to update or revise any forward-looking statements. At this time, I would like to turn the call over to Nick Leschly. Nick?

這些前瞻性陳述代表了我們截至本次電話會議的觀點，不應依賴我們在任何後續日期所代表的觀點。請您注意不要過度依賴這些前瞻性陳述，除非法律要求，否則我們不承擔更新或修改任何前瞻性陳述的義務。此時，我想將電話轉給 Nick Leschly。缺口？

Thanks, Jenn. Good morning, everyone, and thank you for joining us as we discuss our second quarter 2023 results and business updates. We are now well into our second full year as 2seventy bio, executing on our mission of giving more time to people living with cancer through the transformative power of cell therapy. Since the creation of 2seventy, our mission has always been dual-pronged: to deliver on the commercial potential of Abecma and to leverage our translational engine to develop an innovative cell therapy pipeline.

謝謝，珍。大家早安，感謝您加入我們，我們將討論 2023 年第二季的業績和業務更新。現在，我們已進入 2seventy bio 的第二個完整年頭，我們的使命是透過細胞療法的變革力量，為癌症患者提供更多時間。自 2seventy 創建以來，我們的使命始終是雙管齊下：發揮 Abecma 的商業潛力，並利用我們的轉化引擎開發創新的細胞治療管道。

And in the first half of 2023, we've made important progress against these goals. With Abecma, we continue to successfully deliver in the commercial setting to an extensive and growing number of people living with multiple myeloma who are in need of better treatment options. We recently hosted a myeloma patient and his wife at our all-hands meeting, reminding us the impact that Abecma, is having on patients and families. It was humbling, inspiring and a deep reflection of our line.

2023 年上半年，我們在實現這些目標方面取得了重要進展。透過 Abecma，我們繼續在商業環境中成功地為越來越多需要更好治療選擇的多發性骨髓瘤患者提供服務。最近，我們在全體會議上接待了一位骨髓瘤患者和他的妻子，提醒我們 Abecma 對患者和家庭的影響。這是令人謙卑、鼓舞人心的，也是我們產品線的深刻展現。

At the same time, we recognize we are in the midst of a rapidly evolving competitive environment, which is expected to impact the second half of Abecma performance. Chip will comment more fully on Abecma market dynamics. And I can say that we've spent a significant amount of time with the broader BMS team to hear not only their rationale for the long-term belief in the potential of Abecma, but also the month-to-month tactical in-line commercial strategy.

同時，我們認識到我們正處於快速變化的競爭環境中，預計這將影響 Abecma 下半年的表現。 Chip 將更全面地評論 Abecma 市場動態。我可以說，我們與更廣泛的 BMS 團隊花費了大量時間，不僅聽取了他們長期相信 Abecma 潛力的理由，還聽取了每月的戰術內聯廣告策略。

It is both grounded and a strong understanding of the landscape and very well supported by internal resources from the CEO to the sales rep given their conviction to the cell therapy field. Overall, we're making significant short- and long-term investments with BMS to maximize the potential of this important therapy for patients.

它既紮根又對情況有深入的了解，並且得到了從首席執行官到銷售代表的內部資源的大力支持，因為他們對細胞治療領域充滿信心。總體而言，我們正在對 BMS 進行大量的短期和長期投資，以最大限度地發揮這種重要療法對患者的潛力。

On the development side, we continue to apply our scientific knowledge and research engine to address some of the most pressing therapeutic challenges in oncology. We have a number of preclinical and clinical programs in liquid and solid tumors. And the common thread is that we're using layered cell therapy approaches to deliver potentially transformative impact for patients.

在開發方面，我們繼續運用我們的科學知識和研究引擎來解決腫瘤學中一些最迫切的治療挑戰。我們在液體和實體瘤方面有許多臨床前和臨床項目。共同點是我們正在使用分層細胞治療方法為患者帶來潛在的變革性影響。

One such program is DARIC33. Since the Grade 5 AE in June, the 2seventy and Seattle Children's team have conducted the root cause investigation and have developed potential amendments to the PLAT-08 protocol. This past Friday, Seattle Children's received the official notice of the FDA clinical hold. This was expected and we need to hear more from the FDA in terms of their specific concerns and how it will impact the potential path forward for the program. Steve will provide more details later in this call.

DARIC33 就是這樣的程序之一。自 6 月發生 5 級 AE 以來，2seventy 和西雅圖兒童團隊已經進行了根本原因調查，並對 PLAT-08 協議進行了潛在的修訂。上週五，西雅圖兒童醫院收到 FDA 臨床暫停的正式通知。這是預料之中的，我們需要從 FDA 那裡聽到更多關於他們的具體擔憂以及它將如何影響該計劃的潛在前進道路。史蒂夫將在稍後的電話會議中提供更多詳細資訊。

Our pipeline programs are stacked with innovation and represent multiple opportunities for us to make unincremental steps forward for patients with cancer. That said, we will also be clear eyed and disciplined about these programs. And if a program is not flaring a very high bar, we will terminate and allocate capital elsewhere. I look forward to your questions, but for now, I'll hand it over to Chip to take more -- to talk more about Abecma and our Q2 results. Chip?

我們的管道專案充滿了創新，為我們為癌症患者取得持續進步提供了多種機會。也就是說，我們也將對這些計畫保持清醒的頭腦和紀律。如果一個專案沒有達到很高的標準，我們將終止並將資金分配到其他地方。我期待著您的提問，但現在，我將把它交給 Chip 來討論更多關於 Abecma 和我們第二季度業績的問題。晶片?

Thanks, Nick, and thanks to everyone for joining the call. Abecma delivered solid results in the second quarter with $115.1 million of revenue in the United States. As a reminder, we are in a 50-50 COCO with BMS for the U.S. Abecma business and we record collaboration arrangement revenue, which represents our 50% of the operating profit of the U.S. business.

謝謝尼克，也謝謝大家加入電話會議。 Abecma 第二季業績強勁，在美國的營收為 1.151 億美元。提醒一下，我們與 BMS 的美國 Abecma 業務處於 50-50 COCO 狀態，我們記錄了合作安排收入，這代表了我們美國業務營業利潤的 50%。

For the quarter ending June 30, we recorded $24.5 million of collaboration arrangement revenue related to the Abecma collaboration. This is better than we had expected and is driven by an improving gross margin, which in turn has been helped by a continuing improvement in manufacturing success rates, which remain north of 90%. So as expected, the Abecma collaboration is delivering cash flow to 2seventy.

截至 6 月 30 日的季度，我們記錄了與 Abecma 合作相關的合作安排收入 2,450 萬美元。這比我們預期的要好，是由毛利率提高所推動的，而毛利率的提高又得益於製造成功率的持續提高，該成功率仍保持在 90% 以上。正如預期的那樣，Abecma 合作正在為 2seventy 帶來現金流。

As BMS reported in their 2Q earnings, they are forecasting lower revenues in the third quarter with a return to growth in the fourth quarter. Based on this, we have updated our Abecma U.S. revenue guidance for 2023 to the lower end of our original $470 million to $570 million range.

正如 BMS 在第二季收益中報告的那樣，他們預計第三季營收將下降，第四季將恢復成長。基於此，我們將 Abecma 2023 年美國營收指引更新為原來 4.7 億至 5.7 億美元範圍的下限。

We have 3 important points we want investors to hear on this updated forecast: First, the downward revision was not driven by the scheduled maintenance of the S12 manufacturing facility in June. This maintenance was planned and built into the original forecast and as a normal course for aseptic manufacturing processes. The shutdown was successful and we're back online.

關於這項更新的預測，我們希望投資人聽到 3 個要點：首先，向下修正並不是由於 6 月 S12 製造工廠的計畫維護所致。該維護已計劃並納入最初的預測中，並作為無菌製造過程的正常過程。關閉成功，我們重新上線。

Second, the downturn is due to a competitive -- to a dynamic competitive landscape. In the fifth line plus setting, the original patient bolus has been largely addressed, and we are now in an incidence-based market. But with the December PDUFA date for a potential label expansion to third line plus, we believe there is a significant larger opportunity for Abecma coming soon. We are investing with BMS in manufacturing capacity for 2024 and beyond to address this larger market.

其次，經濟低迷是因為競爭──動態的競爭格局所造成的。在第五線+設定中，最初的患者推注已在很大程度上得到解決，我們現在處於基於發病率的市場。但隨著 12 月 PDUFA 日期可能將標籤擴展到第三線以上，我們相信 Abecma 很快就會有更大的機會。我們正在與 BMS 一起投資 2024 年及以後的製造能力，以滿足這個更大的市場。

And third, the BMS commercial team is increasing their sales and marketing efforts on Abecma. We spent the day with the BMS commercial leadership last week, and they are increasing their commercial footprint and intensity across the multiple -- across the myeloma market.

第三，BMS 商業團隊正在加強 Abecma 的銷售和行銷力度。上週我們與 BMS 商業領導層度過了一天，他們正在擴大其在骨髓瘤市場的商業足跡和強度。

We continue to closely manage our expenses and together with the improving contribution from the Abecma collaboration, you can see the impact on our bottom line. For the second quarter of 2023, we recorded a net loss of $42.1 million, down significantly from a net loss of $77.4 million for the same period last year. We remain committed to maintaining our cash runway into at least 2026 and we continue to actively evaluate pipeline investments and our overall cost structure. With that, I'll hand it over to Steve to provide some additional detail on the update we provided this morning regarding our AML program. Steve?

我們繼續密切管理我們的開支，再加上 Abecma 合作不斷提高的貢獻，您可以看到這對我們的利潤的影響。 2023年第二季度，我們錄得淨虧損4,210萬美元，較去年同期的淨虧損7,740萬美元大幅下降。我們仍然致力於至少將現金跑道維持到 2026 年，並繼續積極評估管道投資和整體成本結構。接下來，我將把它交給 Steve，以提供我們今天早上提供的有關 AML 計劃的更新的一些額外詳細資訊。史蒂夫？

Thanks, Chip. Good morning, everyone. In June, we announced the pause of our PLAT-08 study in AML in response to a fatal Grade 5 serious adverse event. This event occurred in the first patient treated at the second dose level in the Phase I trial. It cannot be stated enough that the safety of every patient who participates in our studies or receives our therapies is of utmost priority to us, and we continue to keep the patient's family in our thoughts.

謝謝，奇普。大家，早安。 6 月，我們宣布暫停針對 AML 的 PLAT-08 研究，以應對致命的 5 級嚴重不良事件。這起事件發生在 I 期試驗中接受第二劑量水平治療的第一位患者身上。無論如何強調，每位參與我們研究或接受我們治療的患者的安全對我們來說都是最重要的，我們將繼續將患者的家人放在心上。

Since that time and in collaboration with Seattle Children's, both our partner and the regulatory study sponsor, we have been conducting a thorough investigation of the root cause of this event. This investigation has provided insights into the pathobiology of this toxicity leading to several study protocol changes, which the team believes may mitigate this toxicity and allow for the continuation of the PLAT-08 study.

從那時起，我們與我們的合作夥伴和監管研究贊助商西雅圖兒童醫院合作，一直在對這一事件的根本原因進行徹底調查。這項調查深入了解了這種毒性的病理生物學，導致了多項研究方案的改變，研究小組認為這可能會減輕這種毒性，並允許 PLAT-08 研究的繼續。

As a result, our collective team is actively amending the protocol. And as Nick shared, we received formal notice of FDA clinical hold on Friday afternoon. We will continue to collaborate with Seattle Children's and the FDA to determine appropriate next steps and a potential path forward here. I'm happy to address any questions in the Q&A portion, but for now, we'll pass it back to Nick.

因此，我們的集體團隊正在積極修改協議。正如尼克所分享的，我們在周五下午收到了 FDA 臨床暫停的正式通知。我們將繼續與西雅圖兒童醫院和 FDA 合作，以確定適當的後續步驟和潛在的前進道路。我很高興在問答部分解決任何問題，但現在我們會將其傳遞給尼克。

Thanks, Steve. We appreciate everyone's time. And we'll close by saying that we remain committed to delivering for patients, to innovation and to driving value for shareholders. There is no hiding that it has been hard -- a hard and rapidly evolving period for the company and all stakeholders. We are focused on doing everything we can to adjust and improve our strategic focus and day-to-day execution to enable us to best deliver across all stakeholders, including hard-working, dedicated employees, committed shareholders and, of course, patients and families in need. With that, operator, you may now open the line for questions.

謝謝，史蒂夫。我們感謝每個人的時間。最後我們要說的是，我們仍然致力於為患者提供服務、創新並為股東創造價值。毫無疑問，這對公司和所有利害關係人來說都是一段艱難且快速發展的時期。我們致力於盡一切努力調整和改進我們的策略重點和日常執行，使我們能夠為所有利益相關者提供最好的服務，包括勤奮、敬業的員工、忠誠的股東，當然還有患者和家屬有需要。接線員，現在可以撥打電話提問了。

(Operator Instructions) Our first question comes from the line of Salveen Richter with Goldman Sachs.

（操作員說明）我們的第一個問題來自高盛的薩爾文·里克特（Salveen Richter）。

This is Tommy on for Salveen. Can we just get a little bit more detail about the drivers behind the updated revenue guidance. I believe that you mentioned that it was not due to the prescheduled shutdown, but more so the patient demographics. Just some more color on that would be helpful.

這是薩爾文的湯米。我們能否更詳細地了解更新後的收入指引背後的驅動因素？我相信你提到這不是由於預定的關閉，而是由於患者的人口統計。只要多加一些顏色就會有幫助。

This is Nick. I think Chip can jump into that. I think we've certainly been watching all the various moving parts. And one thing that you know when these maintenances come, we had some confusion in the marketplace. So I think people are looking to that and saying, wasn't that a bit of a surprise? Or would why was that a surprise? And we just want to make clear that it wasn't right? I think what is evolving is the dynamics in the marketplace. And as Chip said and can elaborate a little bit more on along with BMS, we feel confident that as the marketplace continues to evolve and as the expansion of the lines evolves, then so will be the use of Abecma in combination or not in combination in partnership with these other treatments for myeloma. But Chip, do you want to provide a little bit more detail on what we know?

這是尼克。我認為奇普可以涉足這一領域。我想我們肯定一直在關注所有不同的動態部分。你知道的一件事是，當這些維護到來時，我們在市場上出現了一些混亂。所以我認為人們正在關注這一點並說，這不是有點令人驚訝嗎？或者為什麼會讓人感到驚訝？我們只是想澄清這是不對的？我認為不斷變化的是市場的動態。正如 Chip 所說，並且可以與 BMS 一起詳細闡述，我們相信，隨著市場的不斷發展和產品線的擴展，Abecma 的組合使用或不組合使用也將如此。與其他骨髓瘤治療方法合作。但是奇普，你想提供更多關於我們所知道的細節嗎？

No, that was well said. I think what we have seen is an increase in the overall CAR T capacity, both our capacity, competitive capacity as well as the utilization of T cell engagers and collectively more patients in the fifth line plus setting, getting the innovative therapies, which is great for patients. Again, we view that as a moment in time, the field is going to shift yet again towards the end of this year with our PDUFA date and again, with other regulatory approvals coming. Stepping back, myeloma is a huge market. It's a huge opportunity. History has never been a winner take all. And so I think these therapies will all have important roles to play and we certainly see that for Abecma as well.

不，這話說得好。我認為我們看到的是整體 CAR T 能力的提高，包括我們的能力、競爭能力以及 T 細胞接合者的利用率，以及更多第五線以上環境中的患者，獲得創新療法，這很棒對於患者。我們再次認為，隨著 PDUFA 日期的臨近，隨著其他監管機構的批准即將到來，該領域將在今年年底再次轉變。退一步來說，骨髓瘤是一個龐大的市場。這是一個巨大的機會。歷史從來就不是贏家通吃的事情。因此，我認為這些療法都將發揮重要作用，我們當然也為 Abecma 看到了這一點。

Our next question comes from the line of Daina Graybosch with Leerink Partners.

我們的下一個問題來自於 Leerink Partners 的 Daina Graybosch。

We've been doing some KOL interviews recently. And there is some skepticism, I'd say, in the market that there's a lot of -- there'll be a lot of demand for CAR T in the earlier lines of myeloma just given referral dynamics and maybe hesitancy for community docs to refer their patients earlier. And I wonder what work you've done with BMS that gives you confidence and that demand will come and how much more demand you would expect as you move into the earlier lines in KarMMa-3?

我們最近一直在做一些KOL採訪。我想說的是，市場上存在一些懷疑，即考慮到轉介動態以及可能對社區文檔轉介猶豫不決，早期骨髓瘤系列對 CAR T 會有大量需求他們的病人更早。我想知道您在 BMS 方面所做的哪些工作給了您信心以及需求將會到來，以及當您進入 KarMMa-3 的早期生產線時您預計會有多少需求？

This is Nick. I'll take a quick stab. I think you can call 100 doctors, probably get 100 different answers. Our view and our conviction and our research in collaboration with BMS is pretty clear that we do think there's a very strong role for CAR T and a very strong role for that as it gets earlier because at the end of the day, cancer is about efficacy. It is about having a dramatic impact and the sooner you can have that, the more impactful it will be over the long term.

這是尼克。我會快速刺一下。我想你可以給100個醫生打電話，可能會得到100個不同的答案。我們的觀點、我們的信念以及我們與BMS 合作的研究非常清楚，我們確實認為CAR T 具有非常強大的作用，而且隨著它的出現越來越早，它的作用也非常強大，因為歸根結底，癌症是關於療效的。這是為了產生巨大的影響，越早產生這種影響，長遠來看，影響力就越大。

So we think that certainly has to be proven out through the data, but it is starting to be proven out by the data by us as well as other CAR Ts. So in that sense, we have a very strong conviction that fifth line, fourth line, third line, second line and certainly, first line is going to be an area where we'll have a very strong contribution in place in the marketplace. Convenience is certainly a factor, especially if you have no alternatives. So for example, in the fifth-line setting, if you can't get a hold of our CAR T, what are you going to do? If you don't have time, you're going to take whatever is available. And that is the dynamic that we've seen.

所以我們認為這當然必須透過數據來證明，但我們和其他 CAR T 已經開始用數據來證明這一點。因此，從這個意義上說，我們堅信第五條線、第四條線、第三條線、第二條線，當然還有第一條線將成為我們在市場上做出強有力貢獻的領域。方便無疑是一個因素，尤其是在您別無選擇的情況下。那麼比如說，在五線設定中，如果你拿不到我們的CAR T，你該怎麼辦？如果你沒有時間，你就會利用一切可用的東西。這就是我們所看到的動態。

We don't think that is a data-driven dynamic. That is an availability driven dynamic. And so over time, that will, we believe, evolve, especially as we get into third line and then as you go even further. And I think we've heard the same thing out of our J&J colleagues as well as anyone else who has a CAR T. So we're pretty confident but again, that's something we'll have to play out quarter-by-quarter.

我們認為這不是數據驅動的動態。這是可用性驅動的動態。因此，隨著時間的推移，我們相信，這將會演變，特別是當我們進入第三線，然後當你走得更遠時。我認為我們從強生同事以及其他擁有 CAR T 的人那裡聽到了同樣的說法。所以我們非常有信心，但同樣，這是我們必須逐季度進行的工作。

Our next question comes from the line of Yaron Werber with TD Cowen.

我們的下一個問題來自 Yaron Werber 和 TD Cowen 的對話。

Great. I have a couple of questions. One, when you're thinking dynamically what's going on in the competitive market right now, was the issue in the quarter sort of just prioritizing the wait list or the list in general and clinics to make sure that they match up with supply because, obviously, plenty of demand out there.

偉大的。我有一些問題。一，當你動態思考目前競爭激烈的市場正在發生什麼時，本季的問題是優先考慮等待名單或一般名單和診所，以確保它們與供應相匹配，因為，顯然，需求量很大。

And secondly, it sounds to me like your Q3 is going to be sort of a downtick over Q2 and then Q4 is going to grow over Q3. Can you just explain a little bit? I know July is obviously mostly off-line because of the way it worked out. But are you totally back to your capacity back in May? Or are you able to increase it at this point by the end of the year? And how fast would that happen?

其次，在我看來，第三季將比第二季下降，然後第四季將比第三季成長。能簡單解釋一下嗎？我知道七月顯然大部分時間都是離線的，因為它的運作方式。但是五月的時候你已經完全恢復到你的能力了嗎？或者你能在年底前增加它嗎？這會發生多快？

Chip, do you want to just and I will add a few comments there.

Chip，你願意嗎？我會在那裡添加一些評論。

Yes. Thanks, Yaron. Yes, I think you have it right. The third quarter is impacted by the June shutdown. So again, as we've talked about, the June slots become July revenue. So there's roughly a month lag there. So July is a late month, which contributes to the expectation that the third quarter is down. We do expect a return to growth as we move month-to-month and quarter-to-quarter here driven by a couple of different factors.

是的。謝謝，亞龍。是的，我認為你說得對。第三季受到六月停工的影響。因此，正如我們所討論的，六月的時段變成了七月的收入。所以大約有一個月的滯後。因此，7 月是一個較晚的月份，這加劇了人們對第三季下滑的預期。我們確實預計，在幾個不同因素的推動下，我們會逐月和逐季恢復成長。

We're with BMS expanding the number of sites and the overall commercial footprint. We're expanding the number of reps and people in the field, detailing the backlog, talking to treaters, not just at academic centers, but in the community setting and back to Daina's earlier question, I think that's an important dynamic year as well as that community referral dynamic that's important fifth line will be important in the earlier lines as well. So again, I think it will evolve over time, but we certainly -- from the top on down, this is a priority for us. This is a priority for BMS as well.

我們與 BMS 合作擴大站點數量和整體商業足跡。我們正在擴大該領域的代表和人員數量，詳細說明積壓的工作，與治療人員交談，不僅在學術中心，而且在社區環境中，回到戴娜之前的問題，我認為這是重要的充滿活力的一年，第五行中重要的社區推薦動態在前面的行中也很重要。再說一次，我認為它會隨著時間的推移而發展，但我們當然——從上到下，這是我們的首要任務。這也是 BMS 的首要任務。

And Yaron, just highlight a few things that Chip just said because I think this was and is very active and has been a very active ongoing effort. I'm sure you've chatted with the equivalent folks over at BMS, and we certainly have that there's a pretty dramatic full force investment going on across the capacity, which has been a lot of the focus, but also around sites, around sales, boots on the ground, et cetera, where now you're getting to a more traditional kind of share of voice situation where you want to make sure that people have access but it has still been settling, right? And I view this what happened in the last quarter or the last 6 months, it's still very much a settling phenomenon. It is not a kind of the situation is done and over. That is not the way we look at this, very much a growth and continued settlement.

Yaron，請強調 Chip 剛才所說的一些事情，因為我認為這過去和現在都非常積極，並且一直是一項非常積極的持續努力。我確信您已經與 BMS 的同等人員進行了交談，我們當然知道整個產能正在進行相當大的全力投資，這是很多關注的焦點，但也圍繞網站、圍繞銷售、腳踏實地等等，現在你正處於一種更傳統的聲音分享情況，你想確保人們能夠訪問，但它仍然在解決，對嗎？我認為上個季度或過去 6 個月發生的事情仍然是一個穩定的現象。這並不是一種已經結束的情況。這不是我們看待這個問題的方式，很大程度上是成長和持續的解決。

And I think there's going to be more than enough growth opportunity for both Abecma and certainly the other assets in CAR T as well as the TCEs that are sitting out there are other drugs that are coming forth in myeloma. We've seen that again and again and again. We're just in that early ramp-up phase and Abecma is one of them. And this quarter certainly sort of the situation we're in right now is very much evolving and one that I don't think anyone has a clear understanding on. We're getting one ourselves that is better and one that has led us to a lot of confidence, and we are happy to see that BMS shares that confidence and certainly have no waiver in their stance.

我認為 Abecma 以及 CAR T 中的其他資產以及其他治療骨髓瘤的藥物中的傳統文化表現形式都將有足夠的成長機會。我們已經一次又一次地看到這一點。我們正處於早期的啟動階段，Abecma 就是其中之一。本季我們現在所處的情況肯定正在發生很大的變化，我認為沒有人對此有清晰的認識。我們自己正在獲得一個更好的產品，並且讓我們充滿信心，我們很高興看到 BMS 也有這種信心，當然不會放棄他們的立場。

(Operator Instructions) Our next question comes from the line of Kelsey Goodwin with Guggenheim.

（操作員說明）我們的下一個問題來自凱爾西·古德溫（Kelsey Goodwin）和古根海姆（Guggenheim）的線路。

Maybe shifting gears off of Abecma. Maybe could you just provide some more color on the toxicity root cause analysis in the PLAT-08 study. And maybe could you provide some color on what protocol changes were made post analysis.

也許會放棄 Abecma。也許您可以提供有關 PLAT-08 研究中毒性根本原因分析的更多資訊。也許您可以提供一些有關分析後協議更改的資訊。

Kelsey, this is Nick. Great question. And I'll save my colleague, Steve, here -- Steve from a painful sort of nonanswer. Right now, we're very much -- like you said, we have done the root cause analysis. We're confident that we have some proposals in collaboration with the FDA to get this study sort of back up and enrolling. We can't get into the details of that right now because we want to make sure we honor the relationship not only with the study and the patients but also with the FDA. So that's about as far as we can go at this point in time. So that was -- the wording that we chose there was pretty specific that it's ongoing. We have a plan, it's shared with SCRI and the FDA, engagement has begun. And so we're confident, but we don't share details at a subsequent date.

凱爾西，這是尼克。很好的問題。我會在這裡拯救我的同事史蒂夫——讓史蒂夫免於痛苦的不回答。現在，正如您所說，我們已經完成了根本原因分析。我們有信心與 FDA 合作提出一些建議，以支持這項研究並招募患者。我們現在無法透露細節，因為我們希望確保我們不僅尊重與研究和患者的關係，而且尊重與 FDA 的關係。這就是我們目前所能做到的。所以，我們選擇的措辭非常具體，表明它正在進行中。我們有一個計劃，已與 SCRI 和 FDA 共享，合作已經開始。所以我們有信心，但我們不會在隨後的日期分享細節。

Our next question comes from the line of Vikram Purohit with Morgan Stanley.

我們的下一個問題來自 Vikram Purohit 與摩根士丹利的對話。

Just 2 quick ones from our side. First, on the increased commercial presence you alluded to from BMS aside, could you talk a little bit more about kind of the size and scope of that increased commercial muscle that BMS plans to put into Abecma. What is the scale of that? And what are some of the key messages that you've discussed with BMS that they'll be putting forward to help Abecma compete further? And then secondly, could you remind us what implied from like a pipeline development standpoint in your cash run rate guidance for 2026?

我們這邊只有 2 個快速的。首先，除了您提到的 BMS 商業影響力的增加之外，您能否多談談 BMS 計劃投入 Abecma 的商業力量的規模和範圍。其規模有多大？您與 BMS 討論過哪些關鍵訊息，他們將提出哪些資訊來幫助 Abecma 進一步競爭？其次，您能否提醒我們，從管道開發的角度來看，您的 2026 年現金運作率指引意味著什麼？

It's Nick again. Thanks. Good question. So you're also going to be a little probably sort of not totally associated with my answer. We're not going to provide the details on that expansion there, but it is sizable, and it is significant, both along the sites and the intention there. So that rollout, getting to more and more centers in a rapid fashion, still the leading in the field on that, but also people and boots on the ground across their cell therapy capabilities because the innovation base sell on this. This is something that's really important and that is an exciting piece.

又是尼克。謝謝。好問題。所以你也可能有點不完全同意我的答案。我們不會提供有關該擴展的詳細信息，但它的規模相當大，而且無論是沿著站點還是在那裡的意圖都非常重要。因此，這種推出，以快速的方式進入越來越多的中心，仍然是該領域的領先者，而且人們和靴子也了解他們的細胞治療能力，因為創新基地以此為賣點。這是非常重要的事情，也是令人興奮的事情。

So that I feel a lot of confidence on. And Chris, the incoming CEO there, is very much convicted behind cell therapy always has been. He's been our lead contact throughout our entire relationship. So we're very pleased to see that he got the opportunity to be the incoming CEO. So in that sense, I'm confident around the commitment in that regard. As far as it relates to what the messages are, that will become clear in the field, but we certainly stand behind the real-world evidence and how people are experiencing Abecma in a very consistent manner. Not only from a manufacturing point of view, but from a safety point of view and efficacy point of view.

讓我感覺信心十足。即將上任的執行長克里斯 (Chris) 一直對細胞療法深信不疑。在我們整個關係中，他一直是我們的主要聯絡人。因此，我們很高興看到他有機會擔任新任執行長。因此，從這個意義上說，我對這方面的承諾充滿信心。就資訊內容而言，這一點在現場將會變得清晰，但我們當然支持現實世界的證據以及人們如何以非常一致的方式體驗 Abecma。不僅從製造的角度來看，而且從安全的角度和功效的角度來看。

And so there's lots of ample data out there that will continue to evolve that leads us to believe that it's sort of one of the drugs of choice for sure in the CAR T space. And as it expands, we feel that there is plenty of opportunities that relates to that. And those are the types of messages people are going out there with. And that is, as you know, is going to be a quarter-by-quarter now kind of battle, if you will, but one that BMS is certainly used to and their experience in myeloma is probably exceeds just about any other player in the space given their Celgene history.

因此，有大量的數據將繼續發展，這使我們相信它肯定是 CAR T 領域的首選藥物之一。隨著它的擴展，我們認為有很多與之相關的機會。這些就是人們所傳達的訊息類型。如你所知，如果你願意的話，這將是一場逐季度的戰鬥，但 BMS 肯定已經習慣了這場戰鬥，而且他們在骨髓瘤方面的經驗可能超過了該領域的任何其他參與者。鑑於他們的Celgene 歷史，空間。

Do you want to address that in '26?

你想在 26 年解決這個問題嗎？

Sorry. That's the second question.

對不起。這是第二個問題。

I think the second question was just into '26 and what's assumed there? And I think we assume a contribution from Abecma, which we've already seen and that contribution from a cash flow perspective continues and starts to ramp as we move into the third line setting, but certainly between the overall utilization and the margin pickup that we've seen there. That's something that we feel good about, and we'll continue to closely monitor and drive towards.

我認為第二個問題是 26 年剛提出的，那裡的假設是什麼？我認為我們假設Abecma 做出了貢獻，我們已經看到了這一點，從現金流的角度來看，這種貢獻持續存在，並隨著我們進入第三線設定而開始增加，但肯定是在整體利用率和我們的利潤率上升之間。在那裡見過。這是我們感覺良好的事情，我們將繼續密切監控並努力實現這一目標。

From an investment perspective, we have a number of shots on goal in the clinical setting and then moving into the clinical setting, our goal in the first 15 to 30 patients is to achieve human proof of concept in an incremental way. And either we see that or we move on. I mean, as Nick said before, we allocate capital elsewhere. The other thing that we've been emphasizing and we showed this slide on our R&D Day, but just to say it again, a lot of that R&D is funded through collaborations, whether it's the solid tumor programs with Regeneron, whether it's our investment in Abecma with BMS, we actually have a good amount of subsidy that comes in the collaborations that we've put in place to enable us to prosecute a cell therapy pipeline across a number of programs.

從投資的角度來看，我們在臨床環境中進行了多次嘗試，然後進入臨床環境，我們對前 15 到 30 名患者的目標是以增量方式實現人類概念驗證。我們要么看到這一點，要么繼續前進。我的意思是，正如尼克之前所說，我們將資本分配到其他地方。我們一直強調的另一件事，我們在研發日展示了這張幻燈片，但我再說一遍，很多研發都是透過合作資助的，無論是與再生元的實體瘤項目，還是我們對Abecma 與BMS合作，實際上我們在合作中獲得了大量補貼，使我們能夠在多個項目中推行細胞治療管道。

Just one last thing I'll add to the question. Real quick on the backside of Abecma. Just to go back to it because I find this entertaining is the wrong word, but I find it curious to see how everyone is so quick to draw conclusions on the performance of a drug and the future of a drug based on sort of information that is happening real time. And I think if CAR T has shown us anything over the last couple of years is that we don't know what the hell we're talking about half the time as it relates to what the opportunity is at that moment in time because the field is digesting this, the FDA is digesting this, manufacturing specialists are digesting this, the sites are digesting all this. And that we're still very much in that space.

我要在問題中添加最後一件事。 Abecma 的背面速度非常快。只是回到它，因為我發現這種娛樂這個詞是錯誤的，但我很好奇看到每個人如何如此迅速地根據以下信息對藥物的性能和藥物的未來得出結論實時發生。我認為如果說 CAR T 在過去幾年中向我們展示了什麼的話，那就是我們有一半時間都不知道我們到底在談論什麼，因為它與當時的機會有關，因為這個領域正在消化這一點，FDA正在消化這一點，製造專家正在消化這一點，這些網站正在消化這一切。我們仍然處於這個領域。

So from our point of view, this quarter and the bounciness of this quarter has no reflection on the future of this opportunity as it relates to Abecma. The one thing we know about myeloma is it has unfortunately, a tremendous number of patients that are in need. And that is going to continue to expand and Abecma is going to have a very strong role in that. We feel very strongly about that and it will play out quarter by quarter but the long-term aspects and potential of this medicine has never been a question nor is any question for BMS.

因此，從我們的角度來看，本季和本季的反彈並沒有反映出這個與 Abecma 相關的機會的未來。關於骨髓瘤，我們所知道的一件事是，不幸的是，有大量的患者需要治療。這種情況將繼續擴大，Abecma 將在其中發揮非常重要的作用。我們對此有強烈的感受，並且它將逐個季度地發揮作用，但這種藥物的長期方面和潛力從來都不是問題，對於 BMS 來說也不是任何問題。

Our next question is a follow-up from the line of Daina Graybosch with Leerink Partners.

我們的下一個問題是 Daina Graybosch 和 Leerink Partners 的後續問題。

I'm going to ask another Abecma one. And sorry, Nick, asked you to look at what's happening in the moment. You have really different sites where they're big academic centers and both the competitive CAR T and Abecma are offered. And then BMS has really already expanded it to sites where the other competitive CAR T don't have available sites. And I wonder what you're learning from in these 2 different types of sites competitively, those that have more options and those have fewer options. If you have any insights that you've gained as you have more thoughts available on the demand and the competitiveness and any implications of that going forward.

我要去問另一位 Abecma 的人。抱歉，尼克，請你看看現在發生了什麼事。你有非常不同的網站，它們是大型學術中心，並提供有競爭力的 CAR T 和 Abecma。然後，BMS 實際上已經將其擴展到其他競爭性 CAR T 沒有可用站點的站點。我想知道你從這兩種不同類型的競爭性網站中學到了什麼，那些有更多的選擇，那些有更少的選擇。如果您對需求和競爭力以及未來的任何影響有更多的想法，那麼您獲得了任何見解。

Yes, I do, frankly, and so does BMS. But frankly, it's not one that we're going to spend a lot of time talking about publicly because it is exactly that dynamic that gives us actually quite a bit of confidence, which is there are some centers certainly that have both available. They're one that have, in some cases, just Abecma available, and we're following that at a site-by-site level. And that's something that gives us insight into utilization.

是的，坦白說，我願意，BMS 也是如此。但坦白說，我們不會花很多時間公開討論這個問題，因為正是這種動態給了我們很大的信心，因為肯定有一些中心同時具備這兩種能力。在某些情況下，他們只提供 Abecma，我們正在逐個網站進行追蹤。這讓我們能夠深入了解利用率。

And in some cases, generically speaking, right, people have a good experience with one drug or the other and you're going to move in one direction or the other for a period of time. But as people get and want to use both medicines more frequently, we're not seeing that one light goes out and on light turns on, and that's the end of the story. It's very much not the dynamic. And BMS' footprint has expanded, but has not expanded greatly in the last few months and partly because that's we were going from a demand basis, right, where you're supply constrained, to now go into where you actually want to drive more and more demand because supply is catching up.

在某些情況下，一般來說，人們對一種藥物或另一種藥物有很好的體驗，並且你會在一段時間內朝一個方向或另一個方向前進。但隨著人們越來越頻繁地使用這兩種藥物，我們並沒有看到一盞燈熄滅然後一盞燈亮起，這就是故事的結局。這很大程度上不是動態的。 BMS 的足跡已經擴大，但在過去幾個月並沒有大幅擴大，部分原因是我們從需求基礎開始，對，供應有限，現在進入你真正想要推動更多和需求增加，因為供應正在趕上。

So I continue to have that dynamic. I think Abecma performs very well in the real world. We saw that in the data and also in the dialogue as it relates to how a provider can have very clear expectations of the efficacy and safety profile and clarity on the probability of being able to manufacture.

所以我繼續保持這種活力。我認為 Abecma 在現實世界中表現得非常好。我們在數據和對話中看到了這一點，因為它涉及供應商如何對功效和安全性狀況以及能夠製造的可能性有非常明確的預期。

Lots of those things, I think, puts Abecma in a very good position. And the analytics that I won't go into detail on very much support that. And that's something that will play out. Does that mean we know everything? No, not at all. Does it mean we have confidence about the future and our place in that? I would go so far as to say yes on that. And I think BMS would agree on that. But as you and I both know, BMS certainly is not sort of prone to sharing a tremendous amount of detail at that level because it's sort of not necessarily relevant. It's also a competitive field. So we're going to continue to participate accordingly.

我認為，許多這些因素使 Abecma 處於非常有利的位置。我不會詳細介紹的分析也支持這一點。這就是將會發生的事情。這是否意味著我們知道一切？一點都不。這是否意味著我們對未來以及我們在其中的地位充滿信心？我什至會對此說“是”。我認為 BMS 會同意這一點。但正如你我都知道的那樣，BMS 當然不太願意在該級別共享大量細節，因為它不一定相關。這也是一個競爭激烈的領域。因此，我們將繼續相應地參與。

Our next question comes from the line of John Newman with Canaccord Genuity.

我們的下一個問題來自 Canaccord Genuity 的 John Newman。

So you've discussed in the past about the ongoing work to transition to suspension vector. I think you've actually investigated that in KarMMa-3. Curious when that comes online, should we think about that suspension vector process as giving you more capacity or pushing the success rate even higher. You've always been in a very high success rate, but wondering if it's one of those or perhaps both of those?

您過去已經討論過向懸浮向量過渡的正在進行的工作。我認為您實際上已經在 KarMMa-3 中對此進行了調查。很好奇，當它上線時，我們是否應該將暫停向量過程視為為您提供更多容量或將成功率推得更高。您的成功率一直非常高，但想知道這是其中之一還是兩者都有？

Yes, John, I'm happy to take that one. Yes, the suspension moving towards a commercial approval for that early next year. What that does for us is a couple of things. It certainly will help on the gross margin. Suspension is a more cost-effective way of manufacturing vector, which is a key starting material for our manufacturing process. It also has greater capacity. And so that derisks the supply chain and our ability to continue to scale drug product. Ultimately, drug product is what we're going to be focused on for couple of years to come in terms of increasing capacity there, but factor -- and suspension vector is an important component of that.

是的，約翰，我很高興接受這個。是的，暫停計劃將在明年初獲得商業批准。這對我們來說有幾件事。這肯定會對毛利率有所幫助。懸浮液是一種更具成本效益的製造載體方式，也是我們製造過程的關鍵原料。它還具有更大的容量。因此，這會降低供應鏈的風險以及我們繼續擴大藥品規模的能力。最終，藥品是我們未來幾年在增加產能方面的重點，但懸浮載體是其中的重要組成部分。

And I will show no further questions at this time. I'd like to turn the call back over to Nick Leschly for closing remarks.

目前我不會提出任何進一步的問題。我想將電話轉回尼克萊斯利 (Nick Leschly) 作結束語。

Yes. Thank you, everybody, and thank you for joining and thank you for the questions. And I would encourage you if you want to understand any of these in more detail to reach out to us, we're more than happy to talk about any elements of this. But for now, I'll just thank everyone for joining the call and hope everyone has a great day.

是的。謝謝大家，謝謝你們的加入，也謝謝你們提出的問題。如果您想更詳細地了解其中任何一個，我會鼓勵您聯繫我們，我們非常樂意討論其中的任何內容。但現在，我只想感謝大家加入電話會議，並希望每個人都有美好的一天。

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

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。