2Seventy Bio Inc (TSVT) 2024 Q3 法說會逐字稿

Good day. And thank you for standing by. Welcome to the 2 seventyBio third quarter, 2024 earnings conference call. At this time. All participants are in listen-only mode after the speaker's presentation, there will be a question and answer session to ask a question during the session. You will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised to withdraw your question. Please press star 11 again. Please be advised that today's conference is being recorded.

再會。感謝您的支持。歡迎參加 2 seventyBio 2024 年第三季財報電話會議。此時。演講者演講結束後，所有參與者都處於只聽模式，會議期間將有一個問答環節來提問。您需要在電話上按下星號 11。然後您將聽到一條自動訊息，通知您舉手撤回您的問題。請再按星號 11。請注意，今天的會議正在錄音。

I would now like to hand the conference over to your speaker today, Morgan Shields in corporate communications. Please go ahead.

現在，我想將會議交給今天的發言人、企業傳播部門的摩根希爾茲 (Morgan Shields)。請繼續。

Thank you, operator. Good morning, everyone. And thank you for joining us this morning. We issued a press release on our third quarter, 2024 financial results. The press release can be found in the investors and media section of the company's website at 2 seventybio.com. 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, timelines and expectations with respect to sales efficacy and perceived therapeutic benefits of abecma and statements regarding our financial condition, expectations and future financial results among others, actual actual results may differ materially due to various risks uncertainties and other factors including those described in the risk factor section of our most recent form, 10-K quarterly reports and other sec filings. These forward-looking statements represent our views as of this call and should not be relied upon as 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 on today's call. We are joined by Chip Beard, Chief Executive Officer and Vicky Eatwell, Chief Financial Officer and now I will turn it over to Chip Chip.

謝謝您，接線生。大家早安。感謝您今天上午加入我們。我們發布了關於 2024 年第三季財務業績的新聞稿。新聞稿可在公司網站 2 seventybio.com 的投資者和媒體部分找到。提醒一下，今天的討論將包括與 2seventy Bio 當前計劃和期望相關的前瞻性陳述，這些陳述受制於一定的風險和不確定性。這些前瞻性陳述包括關於我們的策略計劃、時間表和對 abecma 的銷售功效和感知治療益處的期望的陳述，以及關於我們的財務狀況、期望和未來財務結果等的陳述，實際結果可能因各種風險、不確定性和其他因素而存在重大差異，包括我們最新的表格、10-K 季度報告和其他證券交易委員會文件中風險因素部分中所述的因素。這些前瞻性陳述代表了我們在本次電話會議中的觀點，不應被視為代表我們在任何後續日期的觀點。請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今天電話會議上任何前瞻性陳述的義務。執行長 Chip Beard 和財務長 Vicky Eatwell 也加入我們，現在我將把發言權交給 Chip Chip。

Thank you Morgan and thank you all for joining today's call.

謝謝摩根，也謝謝大家參加今天的電話會議。

It's hard to believe that we have six weeks left in 2024. Looking back, we've navigated a tremendous amount of change at 2seventy this year. As a reminder, we ended 2023 with 277 employees a burn rate of $63 million in the fourth quarter of 2023. And uncertainty surrounding Abecma's earlier line approval on return to growth in 2024. We've accomplished a tremendous amount to improve this picture.

很難相信 2024 年只剩下六週了。回顧過去，今年我們在 2seventy 經歷了巨大的變化。提醒一下，截止 2023 年，我們共有 277 名員工，2023 年第四季的資金消耗率為 6,300 萬美元。此外，Abecma 早先的生產線獲準是否能在 2024 年恢復成長仍有不確定性。我們已付出大量努力來改善這一狀況。

We've successfully completed the sale of our oncology and autoimmune R&D pipeline to Regeneron, including about 160 employees. The majority of our real estate footprint for the next several years, we sold our hemophilia a program and related technology to Novo Nordisk for $40 million.

我們已成功完成將我們的腫瘤學和自體免疫研發管線出售給Regeneron的交易，其中包括約160名員工。在接下來的幾年裡，我們將大部分房地產足跡以 4000 萬美元的價格將我們的血友病 A 項目和相關技術出售給了諾和諾德。

We received FDA approval in the third line setting, making aema available to more patients living with multiple myeloma.

我們在三線治療領域獲得了 FDA 批准，使得更多多發性骨髓瘤患者能夠使用 aema。

And we've achieved a significant return to growth for a backline with third quarter US revenues growing 42% over the prior quarter.

我們的後勤部門實現了顯著的恢復成長，第三季美國營收較上一季成長了 42%。

The net result of these changes is that we have streamlined the company focusing the business exclusively on Abecma and continuing to make meaningful progress towards our goal of breakeven operations. Our burn rate was approximately $10 million this quarter and we have 70 employees, the majority of whom are funded through the Abecma Coco Agreement with Bristol Myers quid.

這些變化的最終結果是，我們精簡了公司，將業務重點完全集中在 Abecma 上，並繼續朝著收支平衡的目標取得有意義的進展。本季我們的資金消耗率約為 1000 萬美元，我們有 70 名員工，其中大多數是透過與 Bristol Myers 簽訂的 Abecma Coco 協議獲得資助的。

Looking ahead, we're going to focus on two key priorities for a backline.

展望未來，我們將重點放在後防線的兩個關鍵重點事項。

First, we're going to continue to completely we're going to continue to compete commercially.

首先，我們將持續全面進行商業競爭。

AMA has an important place in a growing car t market in third line. Myeloma. Recent real world evidence studies underscore that Abacha has a well established and differentiated safety profile and has a competitive efficacy profile particularly when patients receive effective bridging therapy prior to treatment.

AMA 在不斷成長的第三線汽車市場中佔有重要地位。骨髓瘤。最近的真實世界證據研究強調，Abacha 具有完善的差異化安全性，並且具有競爭性的療效，特別是當患者在治療前接受有效的橋接療法時。

Second, we are working on optimizing the cost structure of the document to increase the operating margin, cash flow from the business. The decision to discontinue enrollment in the Carmen nine study is an example of the kind of financial discipline we will continue to apply across the business together with B MS. We are looking carefully at ways to streamline expenses across clinical manufacturing and commercial.

第二，我們正在致力於優化文件的成本結構，以增加營業利潤率和業務現金流。決定停止參與 Carmen 九項研究就是我們將與 B MS 一起繼續在整個業務範圍內應用的財務紀律的一個例子。我們正在仔細研究簡化臨床製造和商業費用的方法。

As we approach 2025 we are one step closer breaking even. And as we've said, this creates strategic optionality for 2seventy we'll have more to say when we get there, we're to focus on delivering for patients and creating value for shareholders will remain our true north as we move forward, we'll get to Q&A shortly, but for now, I'll turn it over to Vicki to talk further about the third quarter results, Vickki.

隨著 2025 年的臨近，我們距離達到收支平衡又更近了一步。正如我們所說的那樣，這為 2seventy 創造了戰略可選性，到那時我們還會說更多，我們將專注於為患者提供服務，為股東創造價值，這將是我們前進的真正方向，我們很快就會進入問答環節，但現在，我將把它交給 Vicki，讓她進一步談談第三季度的業績，Vickki。

Thanks Chip third quarter. Back my US revenue as reported by B MS were $77 million which reflects ongoing expansion in the third line setting. As Chip said, this was a strong quarter for us backa revenue growth and we look forward to continuing to deliver this important therapy to even more patients living with multiple myeloma. We also acknowledge that the multiple myeloma market continues to be one that is dynamic and competitive.

感謝Chip第三季。根據 B MS 報道，我的美國收入為 7700 萬美元，這反映了第三線市場的持續擴張。正如奇普所說，這對我們來說是一個強勁的季度，收入成長強勁，我們期待繼續為更多多發性骨髓瘤患者提供這種重要的治療方法。我們也承認多發性骨髓瘤市場仍然是一個充滿活力和競爭激烈的市場。

We expect us aema revenues to be approximately $240 to $250 million for 2024. With the fourth quarter expected to be impacted by the continued competition and a reduction in car t infusion scheduled during the US holiday season.

我們預計 2024 年美國 AEMA 收入將達到約 2.4 億至 2.5 億美元。預計第四季將受到持續競爭和美國假期期間卡特注入減少的影響。

As a reminder, we share equally in the profits or losses of the US affect the business with B MS and we record collaboration arrangement, revenue or loss each quarter, which largely represents our 50% share of revenue COGS and selling expenses related to the US business. In the third quarter, we reported collaborative arrangement revenue of approximately $11 million related to our collaboration with B MS.

提醒一下，我們平等分享美國與 B MS 業務的利潤或損失，並且我們每個季度記錄合作安排、收入或損失，這在很大程度上代表了我們與美國業務相關的 COGS 收入和銷售費用的 50% 份額。第三季度，我們報告與 B MS 合作相關的合作安排收入約為 1,100 萬美元。

Turning briefly to our cost structure. This quarter, we achieved a $10 million or 24% reduction in GAAP operating expenses versus the prior quarter and a $140 million or 52% year-to-date reduction in GAAP operating expenses versus the same period last year, primarily driven by a reduction in R&D expenses. As we said before, we expect operating expenses to continue to decline in 2025. As our team prioritizes streamlining of our cost structure for both ABECMA and our supporting corporate functions. We continue to expect net cash spend in the range of $40 to $60 million for 2024 and cash runway beyond 2027. With that, I'll turn it back to Chip.

簡單談談我們的成本結構。本季度，我們的 GAAP 營業費用與上一季相比減少了 1,000 萬美元（降幅 24%），與去年同期相比，年初至今的 GAAP 營業費用減少了 1.4 億美元（降幅 52%），這主要得益於研發費用的減少。正如我們之前所說，我們預計 2025 年營運費用將繼續下降。因為我們的團隊優先精簡 ABECMA 和我們支援公司職能部門的成本結構。我們繼續預期 2024 年淨現金支出將在 4,000 萬至 6,000 萬美元之間，2027 年後仍有現金儲備。說完這些，我就把話題轉回給 Chip。

Thanks Vicki. As we close, I want to reiterate that we are encouraged by strong growth in AMA sales this quarter and are proud to have executed on what we set out to do at the beginning of this year, bringing us one step closer to break even potentially as soon as 2025 we believe in the potential of Bema to make a meaningful impact on the lives of patients and their families and plan to expand E Bema's reach to as many multiple myeloma patients as possible. I want to extend a heartfelt. Thank you to our people who are working hard to deliver on our mission to deliver more time to patients and their families.

謝謝 Vicki。最後，我想重申，本季度 AMA 銷售額的強勁增長令我們感到鼓舞，我們也為能夠完成今年年初制定的目標而感到自豪，這使我們距離實現收支平衡又近了一步，最早可能在 2025 年，我們相信 Bema 有潛力對患者及其家人的生活產生有意義的影響，併計劃將 E Bema 的覆蓋範圍擴大到多發性骨髓瘤盡可能多的多發性骨髓瘤。我想表達一份衷心的感謝。感謝我們的員工努力工作，完成我們的使命，為患者及其家人提供更多的時間。

With that. We're happy to take questions, operator.

就這樣。接線員，我們很樂意回答您的問題。

Thank you. As a reminder to ask a question. Please press star 1,1 on your telephone and wait for your name to be announced to withdraw your question. Please press star 1,1 again.

謝謝。提醒一下，要問一個問題。請按電話上的星號1,1，等待播報您的名字後再撤回您的問題。請再按一次星號 1,1。

We ask that you please limit yourself to one question. Please stand by while we compile the Q&A roster.

我們要求您只問一個問題。請稍候，我們正在編制問答名單。

Our first question comes from the line of Dana Graybosch with leading partners. Your line is now open.

我們的第一個問題來自主要合夥人 Dana Graybosch 的提問。您的線路現已開通。

Hi guys. Thanks for the question. I wonder now that we've been a couple quarters into this earlier line sales. If you could tell us any of your reflections on the market. I guess specifically how it differs in terms of demand in in total, not just for a back month than you had anticipated. And any earlier line that were surprises to you.

嗨，大家好。謝謝你的提問。我現在想知道我們已經進入這條早期產品線銷售的幾個季度了。如果您能告訴我們您對市場的任何看法。我猜測具體來說，整體需求有何不同，而不僅僅是前一個月的需求與你的預期有何不同。以及之前任何令您感到驚訝的台詞。

Dana. Thanks for the question. Yeah, I would say that the demand is what we expected. You know, different than the original launch in in fourth line plus where there was a bolus of patients. I think this has been more of a steady build. When you look at the overall car T class share, you know, between the two commercially approved products. We had a big step forward here in the third quarter. I think that's driven both by step ups in a combined manufacturing capacity, as well as more sites coming online and being in a position to deliver car T to patients as well as just continued awareness in earlier lines. Third line setting of of car t of the benefit of car t of sequencing of car T relative to T cell engagers. So there's no one stock answer. But I think what we've been encouraged by is the steady growth and pick up in car T class share. And again, our view with the back is that we need to and we'll continue to compete for our, our place in that share. And I know you've, you've written about that. And we were pleased to see that particularly around recent news, but you know, we, we have a meaningful share there. We have a differentiated safety profile. We have patients for whom we think a back my eye can be the right treatment option. And you know, and I think the last thing I would just comment is if you look at the exit, Trj Jacky from the third quarter, we're still by our math, less than 25% penetrated into the overall third line setting. If you assume third line represents something like 16,000 patients in the United States. So our view is that. There's still plenty of room to grow and plenty of more patients to get to and, and we're committed to trying to do that. So, thanks for the question.

達娜。謝謝你的提問。是的，我想說需求正如我們所預期的。您知道，這與最初在第四行推出的版本不同，其中還包含大批患者。我認為這是一個更穩定的建設。當您查看兩款經過商業認可的產品之間的整體 T-Class 汽車份額時，您就會知道。我們在第三季取得了很大進步。我認為這是得益於綜合生產能力的提升，以及更多工廠上線並能夠將 Car T 交付給患者，以及對早期生產線的持續關注。相對於 T 細胞接合器，car T 定序的 car T 益處的第三線設定。因此，沒有一個固定的答案。但我認為，令我們感到鼓舞的是T級車份額的穩定成長和回升。再次強調，我們的觀點是，我們需要並將繼續爭奪我們在該份額中的地位。我知道您已經寫過這方面內容。我們很高興看到這一點，特別是在最近的新聞中，但你知道，我們在那裡佔有重要的地位。我們擁有差異化的安全狀況。對於我們的某些患者，我們認為眼底切除術可能是正確的治療選擇。你知道，我認為我要評論的最後一件事是，如果你看看第三季的退出情況，Trj Jacky，根據我們的計算，我們仍然發現，滲透到整體第三線設定的比例不到 25％。如果你假設第三行代表美國的 16,000 名患者。我們的觀點是這樣的。我們還有很大的發展空間，還有更多的患者需要治療，我們致力於努力做到這一點。感謝您的提問。

Thank you. Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.

謝謝。我們的下一個問題來自高盛的 Salveen Richter。您的線路現已開通。

Hey, thanks. This is Matt on for Salveen.

嘿，謝謝。這是 Salveen 的 Matt。

Was hoping you could speak to what drove the better margins for the Abecma profit share and then separately, it is $400 million in Abecma still the estimated break even point for the overall business. And then finally, kind of given what you've guided to now for four Q. How do you think you're positioned heading into 2025? Thank you.

希望您能談談是什麼推動了 Abecma 利潤份額的提高，然後單獨談談，Abecma 的 4 億美元仍然是整個業務的預計盈虧平衡點。最後，給出您現在對四個 Q 的指導。您認為自己在 2025 年的定位如何？謝謝。

Matt, thanks for those questions. I'll ask Vicki to comment on margin and break even in terms of positioning, you know, heading into 2025. You know, we've guided here, we expect to end 24 of the $240- $250 million range for total back my UF sales not yet guiding for 2025 but as I said in the prior question, we, we certainly have been encouraged by car T class share growth and are are leaning into continue to participate in our share of that. But Vicki, do you want to comment on margin and third quarter margin and then breg break even?

馬特，謝謝你提出這些問題。我會請 Vicki 對 2025 年的定位方面的利潤和損益平衡進行評論。您知道，我們已經在這裡給出了指導，我們預計 2024 年 UF 銷售額將在 2.4 億至 2.5 億美元之間，雖然還沒有為 2025 年制定指導，但正如我在上一個問題中所說，我們確實受到了 T 級汽車份額增長的鼓舞，並且傾向於繼續參與其中。但是 Vicki，你想評論一下利潤率和第三季的利潤率，然後是盈虧平衡嗎？

Yeah. Thanks for the question I would say on the margins, we continue throughout this year, we've really continued to make steady progress on improving those margins. It's largely driven by demand. So obviously, a strong sales quarter pulls through to from a margin perspective. Given the high fixed cost nature of the business, I will say too that we've continued to with our partners at B MS make manufacturing improvements. So we see really strong manufacturing success rate north of 95%. And so that obviously helps as you translate that into margin on the break even question. That's a good one. And in the past, as you, as you noted, Matt, we've, we've guided to about $400 million being the break even sales point for and that's a total us sales for 2seventy as a whole. We think it's closer to $300 million as we sit here today. But we're very much in, in process of evaluating what we think for 2025. And so we'll be able to comment more on that on that later. But closer to 300 is what I would guide.

是的。感謝您的提問，我想說，關於利潤率，我們今年全年都在繼續努力，在提高這些利潤率方面確實取得了穩步的進展。這很大程度上是由需求驅動的。因此，顯然，從利潤率的角度來看，強勁的銷售季度會帶來提振。鑑於業務的高固定成本性質，我還要說的是，我們一直與 B MS 的合作夥伴一起進行製造業改進。因此，我們看到製造成功率確實高達 95% 以上。當您將其轉化為盈虧平衡問題的利潤時，這顯然會有所幫助。那很好。正如您所說，馬特，過去我們預期的損益兩平銷售點約為 4 億美元，這是 2seventy 在美國的總銷售額。我們認為，截至今天，這個數字接近 3 億美元。但我們正處於評估 2025 年目標的過程中。因此我們稍後可以對此發表更多評論。但我的指導數字接近 300。

Thanks, matt

謝謝，馬特

Thank you as a reminder to ask a question at this time. Please press star 11 on your touchtone telephone.

謝謝您提醒我在此時提問。請按鍵電話上的星號 11。

Our next question comes from the line of Samantha Seino with citi. Your line is now open.

我們的下一個問題來自花旗的 Samantha Seino。您的線路現已開通。

Hi, good morning. Thanks very much for taking the question. I appreciate the 2024 guidance. And that seasonality is, is a big part of that. I'm wondering if you could just speak a little bit on the rates that you've seen thus far in four Q and how they compared to the increase you on through Q and, and how we should think about that, trajectory carrying over into 2025. Thanks very much.

嗨，早安。非常感謝您回答這個問題。我很欣賞 2024 年的指導。季節性是其中很重要的一個因素。我想知道您是否可以簡單談談您在四個季度中迄今為止看到的利率，以及它們與整個季度的增幅相比如何，以及我們應該如何看待這種軌跡延續到 2025 年。非常感謝。

Yeah. Hi SAM. Thanks for the call. I mean, thanks for the call. Thanks for the question. Thanks for being part of our call. The Yeah, the rates. You know, that's something that we, we track on a weekly basis. And again, we were very encouraged to see the growth in apes in the third quarter. As we sit here in the fourth quarter, again, II, I would say to the comments on the call, you know, there is seasonality that occurs particularly as think about as people think about where they're going to be, where when they receive those cells and they head into Thanksgiving Christmas those times. You know, that that can be the intensive part of the car t treatment journey for patients. And so, you know, I, I think that's we, we do see that that being said, I think the underlying demand and, and the kind of uptick we've seen since the third line approval back in March has been a real one and that's one that, you know, together with B MS, we're doing everything we can be doing, we should be doing to support commercially. So, again, I think we'll have more to say about 2025 at a later date. But, you know, certainly have been encouraged. And, and really happy with the growth we've seen here in the third quarter.

是的。你好，SAM。感謝您的來電。我的意思是，謝謝你的來電。謝謝你的提問。感謝您參與我們的通話。是的，費率。您知道，這是我們每週都會追蹤的事情。我們非常高興地看到第三季類人猿數量的增長。當我們再次坐在第四季度時，II，我想對電話中的評論說，你知道，存在季節性，特別是當人們考慮他們要去哪裡，當他們收到這些細胞時，他們會進入感恩節和聖誕節的時候。您知道，這可能是患者治療歷程中最緊張的部分。所以，你知道，我認為我們確實看到了這一點，我認為潛在的需求以及自 3 月份第三條線獲批以來我們看到的上漲是真實的，而且，你知道，我們正在與 B MS 一起盡我們所能，我們應該為商業提供支持。所以，我認為我們以後會多談 2025 年。但你知道，我們確實受到了鼓勵。我們對第三季看到的成長感到非常高興。

Thank you. And I'm currently showing no further questions at this time. I'd like to hand the call back over to Chip Baird for closing remarks.

謝謝。目前我沒有其他問題。我想將電話轉回給 Chip Baird，請他做最後發言。

Thanks, thanks operator and thanks to everyone for participating in the call today. We appreciate the time and have a great day.

謝謝，謝謝接線員，也謝謝今天參加電話會議的每個人。感謝您抽出時間並祝您有個愉快的一天。

This concludes today's conference call. Thank you for your participation. 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。