2Seventy Bio Inc (TSVT) 2024 Q1 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good day and thank you for standing by. Welcome to the 2Seventy Bio first quarter 2024 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

    美好的一天,感謝您的支持。歡迎參加 2Seventy Bio 2024 年第一季財報電話會議。 (操作員指示)請注意,今天的會議正在錄製中。

  • I would now like to hand the conference over to your speaker today, Jenn Snyder with 2Seventy Bio. Please go ahead.

    我現在想將會議交給今天的演講者,2Seventy Bio 的 Jenn Snyder。請繼續。

  • Jenn Snyder - SVP, Corporate Affairs

    Jenn Snyder - SVP, Corporate Affairs

  • Thank you, Shannon, and good morning, everyone. Thank you for joining us. This morning, we issued a press release on our first quarter 2024 financial results. The press release can be found in the Investors and Media section of the company's website at 2seventybio.com.

    謝謝香農,大家早安。感謝您加入我們。今天上午,我們發布了有關 2024 年第一季財務業績的新聞稿。新聞稿可在公司網站 2seventybio.com 的投資者和媒體部分找到。

  • As a reminder, today's discussion will include forward-looking statements related 2Seventy Bio's current plans and expectations, which are subject to certain risks and uncertainties.

    提醒一下,今天的討論將包括與 2Seventy Bio 目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。

  • These forward-looking statements regarding regarding our strategic plans, timelines and expectations with respect to sales, efficacy and perceived therapeutic benefits of Abecma, the timing and review of additional studies and regulatory application for Abecma and statements regarding our financial condition expectations and future financial results among others.

    這些前瞻性陳述涉及我們對Abecma 的銷售、功效和感知治療益處的策略計劃、時間表和預期、Abecma 的其他研究和監管申請的時間表和審查,以及有關我們的財務狀況預期和未來財務業績的陳述除其他外。

  • 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, quarterly reports and other SEC filings.

    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、季度報告和其他 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 as representing our views as of any subsequent date. And 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.

    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。除法律要求外,我們不承擔更新或修改任何前瞻性聲明的義務。

  • On today's call, we are joined by Chip Baird, Chief Executive Officer; and Vicki Eatwell, Chief Financial Officer; and Anna Truppel-Hartmann, Chief Medical Officer is also on the line for questions during the Q&A.

    執行長 Chip Baird 也參加了今天的電話會議;財務長 Vicki Eatwell;首席醫療官 Anna Truppel-Hartmann 也在問答環節回答問題。

  • And now I will turn it over to Chip. Chip?

    現在我將把它交給奇普。晶片?

  • Chip Baird - CEO

    Chip Baird - CEO

  • Thank you, Jenn, and thank you all for joining this morning. Today, we disclosed our first quarter 2024 financial results and recent business and operational updates. I'd like to walk through some of the business updates and then Vicki Eatwell, our Chief Financial Officer, will go into detail on our financials.

    謝謝你,Jenn,也謝謝大家今天早上的加入。今天,我們揭露了 2024 年第一季財務業績以及最近的業務和營運更新。我想介紹一些業務更新,然後我們的財務長 Vicki Eatwell 將詳細介紹我們的財務狀況。

  • First quarter of 2024 was an eventful one. We completed a major strategic realignment to focus exclusively on Abecma to achieve this, we sold our oncology and auto immune R&D programs to Regeneron. As part of the sale, we transferred approximately 160 employees and approximately 67% of our real estate footprint to Regeneron.

    2024 年第一季是多事之秋。為了實現這一目標,我們完成了一項重大策略調整,專門專注於 Abecma,並將我們的腫瘤學和自體免疫研發項目出售給再生元 (Regeneron)。作為出售的一部分,我們將約 160 名員工和約 67% 的房地產業務轉移到 Regeneron。

  • We think this is an ideal outcome for the science and these programs, and we look forward to seeing what the team can achieve in years to come. We also took the tough but necessary decision to reduce headcount by an additional 14% as part of the strategic refocusing.

    我們認為這對科學和這些專案來說是一個理想的結果,我們期待看到團隊在未來幾年能取得什麼成果。作為策略調整的一部分,我們也做出了艱難但必要的決定,將員工人數額外減少 14%。

  • The end result is that we have emerged with a leaner cost structure, cash runway beyond 2027 and time to get it back on back on track commercially to that end, we have consistently said that the path to have excellent growth hinges on earlier line approval.

    最終結果是,我們擁有更精簡的成本結構、2027 年以後的現金跑道,以及為此目的使其在商業上重回正軌的時間,我們一直表示,實現出色增長的道路取決於早期的生產線批准。

  • We traveled quite a journey on this front, including an ODAC meeting in March to advise FDA on our supplemental BLA. the 270 and BMS teams did an amazing job at the panel, and we were subsequently approved in earlier line setting, which opens a much larger addressable patient population.

    我們在這方面走了相當長的路,包括 3 月舉行的 ODAC 會議,就我們的補充 BLA 向 FDA 提供建議。 270 和 BMS 團隊在小組中做了出色的工作,我們隨後在早期的生產線設置中獲得了批准,這開闢了更大的可尋址患者群體。

  • So it's been a great start to the year, and we are now singularly focused on getting a back-to-back contract commercially. We are in the early days of launch and expect it will take into the second half before we see meaningful growth.

    因此,這是今年的一個好開端,我們現在專注於獲得背對背的商業合約。我們正處於發布的早期階段,預計要到下半年才能看到有意義的成長。

  • We've talked for some time now about known strength to our backlog, including strong efficacy. That is reproduced in the real-world setting a well-established and manageable safety profile and consistent manufacturing turnaround time and high rates of inspect product with commentary data in the label and real-world evidence that continues to mature. We believe we have a competitive profile in earlier line triple class exposed patients, which is a population with high unmet need.

    我們已經討論了一段時間我們積壓的已知實力,包括強大的功效。這在現實世界中得到了重現,設置了完善且可管理的安全配置文件、一致的製造週轉時間以及高檢驗率的產品,並帶有標籤中的評論數據和不斷成熟的現實世界證據。我們相信,我們在早期三級暴露患者中具有競爭力,這是一個需求未被滿足的族群。

  • To be clear, multiple myeloma is a competitive market space and a return to growth will take time. But we have a strong commercial organization and launch strategy that we believe in and we look forward to executing on the plan.

    需要明確的是,多發性骨髓瘤是一個競爭激烈的市場空間,恢復成長需要時間。但我們擁有強大的商業組織和啟動策略,我們對此深信不疑,並期待執行該計劃。

  • I'm happy to talk about our strategy in the Q&A, but for now, I will turn it over to our newly promoted CFO, Vicki Eatwell talk about first quarter results. Vicki?

    我很高興在問答中談論我們的策略,但現在,我將把它交給我們新晉升的財務長 Vicki Eatwell 談論第一季的業績。維姬?

  • Jenn Snyder - SVP, Corporate Affairs

    Jenn Snyder - SVP, Corporate Affairs

  • Thanks, Chip. First quarter of Acme U.S. revenues as reported by Bristol-Myers Squibb for $52 million, which was in line with our expectations and reflects ongoing competition in the late-line setting. As Chip stated, we are in the midst of a commercial launch following the recent FDA approval of Abecma based on our Karma three study, which greatly increases the addressable patient population.

    謝謝,奇普。根據百時美施貴寶報告,Acme 美國第一季營收為 5,200 萬美元,符合我們的預期,並反映了後期環境中持續的競爭。正如 Chip 所說,繼 FDA 最近根據我們的 Karma 三研究批准 Abecma 後,我們正處於商業啟動階段,這大大增加了可尋址的患者群體。

  • We look forward to delivering it back to an increased number of patients and expect to see a return to growth in the second half of the year as a reminder, we share equally in the profits or losses of the US investment business with DMS.

    我們期待將其返還給更多的患者,並預計下半年將恢復成長,這提醒我們,我們與 DMS 平等分享美國投資業務的利潤或虧損。

  • And we record collaboration arrangement revenue or loss each quarter, which largely represents our 50% share of revenue, cost of goods sold and selling expenses related to the US business. In the first quarter, we reported share of collaboration loss of $1.2 million related to our collaboration with BMS, driven by decreased patient demand in the late-line setting.

    我們每季都會記錄合作安排的收入或損失,這在很大程度上代表了我們與美國業務相關的收入、銷售成本和銷售費用的 50% 份額。第一季度,由於後期病患需求減少,我們與 BMS 的合作導致了 120 萬美元的合作損失。

  • Turning briefly to our cost structure. And as a reminder, the sale of our R&D pipeline to Regeneron combined with our cost saving actions is expected to achieve $150 million to $200 million of cost savings in 2024 and 2025, respectively.

    簡要談談我們的成本結構。需要提醒的是,將我們的研發管線出售給 Regeneron 並結合我們的成本節約行動,預計將在 2024 年和 2025 年分別實現 1.5 億至 2 億美元的成本節約。

  • We anticipate staying within our previously guided net cash spend range of $80 million to $100 million from 2024. And we are committed to carefully managing our spend to preserve cash runway as we reported last quarter, we expect our runway to go beyond 2027 and see a path to potential breakeven by 2025 as the Abecma returns to growth.

    我們預計從2024 年起,淨現金支出將保持在先前指導的8000 萬美元至1 億美元的範圍內。預計我們的現金跑道將在2027 年後持續成長,並看到隨著 Abecma 恢復成長,到 2025 年可能會達到盈虧平衡。

  • With that, I'll turn it back to Chip.

    有了這個,我會把它轉回給奇普。

  • Chip Baird - CEO

    Chip Baird - CEO

  • Thanks, Vicki, for closer to thoughts. First, we've been through a lot of change in the first quarter, but one thing that is unchanged our patient focus, we believe in the potential of that front to make a meaningful impact for patients in the earlier-line setting and are singularly focused on delivering more time for every myeloma patient we're able to serve together with our partners at BMS, this will be a top priority.

    謝謝維姬,讓我們更接近想法。首先,我們在第一季度經歷了很多變化,但有一點我們對患者的關注點沒有改變,我們相信這一前沿有潛力對早期患者產生有意義的影響,並且是獨一無二的我們致力於與BMS 的伴侶一起為每位骨髓瘤患者提供更多的服務時間,這將是我們的首要任務。

  • Second, we're focused on being careful stewards of investor capital, staying focused on reaching breakeven and profitability and driving value for shareholders together with Vicki on our Jeff and the rest of the team, we will continue to focus on these priorities to drive value

    其次,我們專注於謹慎管理投資者資本,繼續專注於實現盈虧平衡和盈利能力,並與我們的傑夫和團隊其他成員一起為股東創造價值,我們將繼續專注於這些優先事項以推動價值

  • And with that, we're happy to take questions. Operator?

    因此,我們很樂意回答問題。操作員?

  • Operator

    Operator

  • (Operator Instructions) Daina Graybosch, Leerink Partners.

    (操作員說明)Daina Graybosch,Leerink Partners。

  • Unidentified Participant 1

    Unidentified Participant 1

  • Hi, this is Robert on for Daina. Thank you for the question or the question is related to backlog profitability, how should we think about a backlog, collaboration profitability going forward? Is there a threshold revenue above which the program will be consistently profitable given the flat sales over the last three quarters. What is driving this fluctuation in profitability and collaboration loss from quarter to quarter? And can we better anticipate these fluctuations in our model? And then there's a short follow up after that?

    大家好,我是戴娜的羅伯特。謝謝您提出的問題,或問題與積壓獲利能力有關,我們該如何考慮未來的積壓、協作獲利能力?考慮到過去三個季度的銷售持平,是否存在收入門檻,高於該門檻該計劃將持續盈利。是什麼導致獲利能力和合作損失逐季波動?我們能否更好地預測模型中的這些波動?然後有一個簡短的後續行動嗎?

  • Chip Baird - CEO

    Chip Baird - CEO

  • Sure. I'll comment briefly and then as I think you'd add color. But I mean this fifth line plus setting, we've been fairly flat on the revenue side, for the last couple of quarters and hovering with a small collaboration revenue or small share collaboration loss that we saw this quarter in that $50 million -- $50 million revenue run rate on a quarterly basis.

    當然。我將簡要評論,然後我認為您會添加顏色。但我的意思是,在第五行加上設置,我們在過去幾個季度的收入方面相當持平,徘徊在小額協作收入或小額份額協作損失中,我們在本季度看到了5000 萬美元- 50美元按季度計算的百萬收入運行率。

  • So we're going to need to see that return to growth to see a consistent path towards our collaboration, revenue and profitability. And again, we think we have the plan to do that. I would note too that that profitability, as we increase revenues is helped by a better and better capacity utilization on the manufacturing side.

    因此,我們需要看到成長的回歸,以看到我們的合作、收入和盈利能力的一致道路。再說一遍,我們認為我們有計劃這樣做。我還要指出的是,隨著我們收入的增加,獲利能力得益於製造業方面越來越好的產能利用率。

  • We have, as is typical of CAR-T manufacturing, a high fixed cost structure. And so the more volume we can push through there, the better the margins will become so more to come on that front. But certainly we believe in that path and at levels that we achieved before, we believe this is a a profitable business.

    正如典型的 CAR-T 製造一樣,我們擁有較高的固定成本結構。因此,我們在這方面的銷售量越多,這方面的利潤就會越高。但我們當然相信這條道路,並且按照我們之前達到的水平,我們相信這是一項有利可圖的業務。

  • Unidentified Participant 1

    Unidentified Participant 1

  • Thank you. And then just on that manufacturing -- thanks Chip, for going in that direction. How will this shift to suspension vector impact profitability? And when should we expect that transition from adherent to suspension play out in the collaboration of profitability line?

    謝謝。然後就在製造方面——感謝奇普,感謝他朝這個方向前進。這種懸吊向量的轉變將如何影響獲利能力?我們什麼時候可以預期獲利線的協作從堅持到暫停的轉變會發生?

  • Chip Baird - CEO

    Chip Baird - CEO

  • Yeah. So we as we've shared, we've been approved for suspension, which is great news and another important point of execution on the manufacturing side. And that helps certainly from a capacity perspective as well as an overall cost to treat a patient of that transition from adherent to suspension.

    是的。因此,正如我們所分享的,我們已被批准暫停,這是個好消息,也是製造方面執行的另一個重要點。從容量角度以及治療從依從到暫停過渡的患者的整體成本來看,這肯定會有所幫助。

  • In terms of the actual impact on costs will happen over time as we use remaining inherent vector and then make that code over to suspension. But to you from a technical risk perspective, we're past that and we're approved for utilization there, which is great.

    就成本的實際影響而言,隨著時間的推移,我們會使用剩餘的固有向量,然後將該程式碼暫停。但從技術風險的角度來看,我們已經克服了這一點,並且已獲准在那裡使用,這很棒。

  • Operator

    Operator

  • Salveen Richter, Goldman Sachs.

    薩爾文·里克特,高盛。

  • Unidentified Participant 2 - Analyst

    Unidentified Participant 2 - Analyst

  • Hey, thanks. This is Matt on for Salveen. You noted meaningful applications for meaningful growth in second half. Could you expand on that or maybe quantify in any way? And then could you speak to the current dynamics of the launch and how much of it is competition from bispecifics, where corporate versus supply constraints?

    嘿,謝謝。這是薩爾文的馬特。您注意到下半年有意義的成長的有意義的應用。您能否對此進行擴展或以任何方式進行量化?然後您能否談談當前的推出動態以及其中有多少來自雙特異性藥物的競爭,其中企業與供應限制?

  • And then just a follow-up question. Could you please talk about your expectations for OpEx spend in the rest of 2024 and 2025? Thank you.

    然後是一個後續問題。您能否談談您對 2024 年剩餘時間和 2025 年營運支出的預期?謝謝。

  • Chip Baird - CEO

    Chip Baird - CEO

  • Sure. I didn't catch the last part of your view of the three partners question there. Could you say the last part again?

    當然。我沒有聽清楚您對三個合夥人問題的最後部分看法。你能再說一次最後那部分嗎?

  • Unidentified Participant 2 - Analyst

    Unidentified Participant 2 - Analyst

  • The last part was just OpEx spend in 2024 and 2025?

    最後一部分只是 2024 年和 2025 年的營運支出?

  • Chip Baird - CEO

    Chip Baird - CEO

  • Yes, great, yeah. And so in terms of that meaningful growth. We haven't gotten specific on that. But from these levels, again, it doesn't take a lot in what is a much larger market to be posting meaningful growth as a reminder, and we achieved over [$100 million] of revenue in the first and second quarter of last year and a much smaller defined plus market.

    是的,很棒,是的。因此,就有意義的成長而言。我們還沒有具體說明這一點。但從這些水準來看,再次提醒大家,在一個更大的市場中並不需要太多就能實現有意義的成長,我們在去年第一季和第二季實現了超過[1 億美元] 的收入,一個小得多的限定附加市場。

  • So with the expanded label, we feel very excited about the market opportunity and about the dataset that stands behind that and our ability to engage with treating physicians and educate on our product profile, which is different and improved, and we can get into some of that size. And that's what I would say in terms of the path to meaningful growth in the second half of the year. I'll turn it to Vicki to comment on OpEx

    因此,隨著標籤的擴展,我們對市場機會和背後的數據集感到非常興奮,也對我們與治療醫生接觸並教育我們的產品概況的能力感到非常興奮,這是不同的和改進的,我們可以進入一些那個尺寸。這就是我所說的下半年實現有意義成長的道路。我會把它轉給 Vicki 來評論 OpEx

  • Vicki Eatwell - CFO

    Vicki Eatwell - CFO

  • I just address the question on supply constraints, we are not supply constrained. We have enough capacity to meet our existing label. And further, we have the ability to expand capacity within it within our existing manufacturing infrastructure.

    我只是解決供應限制的問題,我們沒有供應限制。我們有足夠的產能來滿足我們現有的標籤要求。此外,我們有能力在現有的製造基礎設施內擴大產能。

  • And just to turn to your question on OpEx, when we think about spend in 2024, excluding noncash OpEx, we're characterizing 2024 as being about half of what 2023 spend was. And as we turn to 2025, I would guide that spend would be about a third of what we would have expected of what we experienced in 2023. So I would use that for from a modeling perspective.

    回到你關於營運支出的問題,當我們考慮 2024 年的支出(不包括非現金營運支出)時,我們將 2024 年的支出描述為 2023 年支出的一半左右。當我們轉向 2025 年時,我預計支出將約為 2023 年預期支出的三分之一。

  • Operator

    Operator

  • Kelsey Goodwin, Guggenheim Securities.

    凱爾西‧古德溫,古根漢證券公司。

  • Kelsey Goodwin - Analyst

    Kelsey Goodwin - Analyst

  • Oh, hey, good morning. Thanks for taking my question first, I guess, can you provide any early commentary on what you're seeing and hearing kind of post label expansion with Karma three?

    哦,嘿,早安。感謝您首先提出我的問題,我想您能否對您所看到和聽到的 Karma 3 的後廠牌擴展提供任何早期評論?

  • And then I guess maybe prior to the expansion in terms of the competition and the headwinds you were facing previously were or are you seeing that mainly from CAR-T competitors or bispecifics or a blend and just kind of the market in general, just trying to get a little more color there.

    然後我想也許在競爭擴張之前,您之前面臨的逆風是或您看到的主要來自 CAR-T 競爭對手或雙特異性藥物或混合藥物以及一般市場,只是試圖那裡多一點顏色。

  • Chip Baird - CEO

    Chip Baird - CEO

  • Thanks so much, Kelcy. Yes, thanks. Good questions. I'll take the second first, which is from a competitor perspective, as we've said in myeloma, is a competitive field. And I think on CAR-T competition as well as by specs, are all at play in the in kind of where we stand with that fifth line plus setting, I think it is a bit of a reset as we move into the third line setting on today by specs are not present there.

    非常感謝,凱爾西。對了謝謝。好問題。我首先考慮第二個,這是從競爭對手的角度來看,正如我們在骨髓瘤中所說的那樣,是一個競爭領域。我認為 CAR-T 競爭以及規格都在我們所處的第五行加設定中發揮作用,我認為當我們進入第三行設定時,這有點重置今天的規格不存在那裡。

  • And again, I think our focus commercially is some articulating the Beckman story and the data set that we have there. And again, I think asking and engaging with treating physicians to them to look at their own patients and the experience with the product across all dimensions of our efficacy, safety, manufacturing, reliability, all of that.

    再說一遍,我認為我們在商業上的重點是闡明貝克曼的故事和我們在那裡的數據集。再說一次,我認為要求治療醫生並與他們接觸,讓他們了解自己的患者以及我們在功效、安全性、製造、可靠性等各個方面的產品體驗。

  • So we are we've got a strong belief set there. We had a terrific launch meeting with MS team last month, and I would say it's early days. So don't ask me the question on commentary again in a month or two, but we're certainly fired up and ready to go and out engaging with the treating physician community.

    所以我們有一個堅定的信念。上個月我們與 MS 團隊舉行了一次精彩的啟動會議,我想說現在還為時過早。因此,一兩個月後不要再問我有關評論的問題,但我們肯定已經興奮不已,準備好與治療醫生社區接觸。

  • Operator

    Operator

  • Yaron Werber, TD Cowen.

    亞龍·韋伯,TD·考恩。

  • Unidentified Participant 3 - Analyst

    Unidentified Participant 3 - Analyst

  • Hi, this is Gina on for Yaron. Thanks for taking my questions. Two parter from me. So you're saying that the overall efficacy manufacturability are points of differentiation for Abecma. Can you remind us what your current manufacturing success rate out of spec rate over a Abecma.

    大家好,我是亞龍的吉娜。感謝您回答我的問題。我的兩個夥伴。所以你是說整體功效可製造性是 Abecma 的差異化點。您能否提醒我們,您目前的製造成功率相對於 Abecma 的不合格率是多少?

  • Also vein-to-vein time and the second part is on the attack in March. The committee seemed a little bit concerned about PFS for a government not being durable. Student is going to hinder our Beckman uptake in earlier line settings. Thank you.

    同樣是針鋒相對的時間,第二部分是三月的進攻。委員會似乎有點擔心政府的 PFS 不持久。學生將阻礙我們在早期生產線設置中吸收貝克曼。謝謝。

  • Chip Baird - CEO

    Chip Baird - CEO

  • Yes, thanks for the question. On on on manufacturing success rates, we're north of 90% manufacturing and spec, and that's been consistent for quite some time. Now I'm always looking to do even better for every patient.

    是的,謝謝你的提問。就製造成功率而言,我們的製造和規格已達到 90% 以上,而且這種情況在相當長的一段時間內保持不變。現在,我一直希望為每位患者做得更好。

  • And as we move into earlier lines and with cells that are have seen less lines of therapy, we're optimistic that that could get even better. And then from a turnaround time, we've been consistently just system a little bit under 30 days on turnaround time. I'm sorry, can you remind me the question. Gina, are you still there?

    當我們進入早期的細胞系和接受較少治療的細胞時,我們樂觀地認為情況會變得更好。從週轉時間來看,我們的系統週轉時間一直略低於 30 天。抱歉,你能提醒我這個問題嗎?吉娜,你還在嗎?

  • Unidentified Participant 3 - Analyst

    Unidentified Participant 3 - Analyst

  • Can I unmuted asking about durability of PFS and how it all right into the panel?

    我可以直接詢問 PFS 的耐用性以及它如何進入面板嗎?

  • Chip Baird - CEO

    Chip Baird - CEO

  • Yes, sorry. Thank you. Yes, from that, we think that the panel took a study that was focused on PFS and I think really go deep on overall survival. And you know the confounding factors that that study but 13 months of PFS versus on the standard of care, which demonstrated about four months. We had that we felt that was a statistically significant statistically significant difference on the prespecified primary endpoints so we feel good about those data. And as you get into subgroup analysis on, we believe it looks even better. I'm sorry, on an honest, not the same room with us. Anna, could you comment further on that one?

    是的,抱歉。謝謝。是的,據此,我們認為該小組進行了一項專注於 PFS 的研究,我認為確實深入研究了整體存活率。您知道研究的混雜因素,但 13 個月的 PFS 與標準護理相比,後者顯示了大約 4 個月的 PFS。我們認為,在預先指定的主要終點上存在統計上顯著的統計學顯著差異,因此我們對這些數據感覺良好。當您進行亞組分析時,我們相信它看起來會更好。對不起,說實話,和我們不在同一個房間。安娜,你能進一步評論一下嗎?

  • Anna Truppel-Hartmann - Chief Medical Officer

    Anna Truppel-Hartmann - Chief Medical Officer

  • Thank you so much, and thank you for the good questions. And it was it does discuss the Oregon also commended by the biostatistician. And it is to be noted, noted that the PFS analysis has a certain data cut with also certain data maturity.

    非常感謝您,也感謝您提出的好問題。正是它確實討論了俄勒岡州也受到生物統計學家的讚揚。要注意的是,PFS 分析有一定的資料切割,也有一定的資料成熟度。

  • And with more follow-up of course, and there is more centering in curve and it was clearly know that also the old act there was some censoring before the end. So it is definitely not a mature curve. That's one.

    當然,隨著更多的後續行動,曲線也更加集中,而且很明顯,舊的表演在結束之前也有一些審查。所以它絕對不是一個成熟的曲線。這是一個。

  • Second, we have served to PFS data cuts that are in the public domain. If you look at the second PFS data cut is seems to be really going apart a bit better.

    其次,我們為公共領域的 PFS 資料削減提供服務。如果你看第二次 PFS 資料切割,你會發現情況確實好一些了。

  • And finally, I'd like to also mention we're speaking about multiple myeloma patients who unfortunately still do not have a cure at this point in time. So therefore, we would expect that at some point in time, patients relapse and then need to go to the next therapy. So that's all from my end on the on the PFS a discussion about activity.

    最後,我還想提一下,我們談論的是多發性骨髓瘤患者,但不幸的是,他們目前仍無法治癒。因此,我們預期在某個時間點,患者會復發,然後需要下一次治療。這就是我在 PFS 上關於活動的討論的全部內容。

  • Chip Baird - CEO

    Chip Baird - CEO

  • Thanks, Ana.

    謝謝,安娜。

  • Operator

    Operator

  • Samantha Synenco with Citi.

    Samantha Synenco 的花旗銀行。

  • Unidentified Participant 4

    Unidentified Participant 4

  • Hey, this is Eric on for Sam. Thanks for taking our questions. Can you speak to any utilization trends you're seeing across treatment centers where Abecma is the only BCMA CAR-T available versus those that offer carbon-free as well and are you seeing utilization across all activated treatment centers? Or is it clustered in a subset? And if so, can you characterize that subset?

    嘿,這是艾瑞克為山姆發言。感謝您回答我們的問題。您能否談談您在治療中心看到的任何利用趨勢,其中 Abecma 是唯一可用的 BCMA CAR-T 與那些提供無碳的治療中心相比,您是否看到所有激活的治療中心的利用趨勢?還是它聚集在一個子集中?如果是這樣,你能描述這個子集的特徵嗎?

  • Chip Baird - CEO

    Chip Baird - CEO

  • Yes. Thanks for the question. As we track. Obviously, the utilization data across all the centers where we're activated on and those saw those trends can vary over time. And again, we have centers that are have higher rates of utilization and ones that are less. So I would I would say the academic centers, the major centers side, you tend to drive a lot of the overall utilization.

    是的。謝謝你的提問。當我們追蹤時。顯然,我們激活的所有中心以及看到這些趨勢的中心的利用率數據可能會隨著時間的推移而變化。再說一遍,我們的中心有利用率較高的,也有使用率較低的。所以我想說的是,學術中心、主要中心面,往往會推動整體使用率的提升。

  • But from a growth perspective, extending the overall footprint to more geographically remote places the United States on is helpful for those patients where we're travel time to receive their CAR T and the follow-up involves matters. And so we think our site expansion is important part of the overall commercial strategy.

    但從成長的角度來看,將整體足跡擴展到美國地理上更偏遠的地方對於那些我們需要時間接受 CAR T 且後續涉及問題的患者來說是有幫助的。因此,我們認為我們的網站擴張是整體商業策略的重要組成部分。

  • And again, we're engaging right now with every one of those centers highlighting the common three data, the data that are on the label on the real-world evidence and everything else that we're able to do and compliantly in the commercial setting. So more to come on that. But, again, as we've said before, we're excited to get back out there with a new and expanded data set.

    再說一次,我們現在正在與每個中心合作,強調共同的三個數據,現實世界證據標籤上的數據以及我們在商業環境中能夠做到並合規的所有其他數據。所以還有更多的事情要做。但是,正如我們之前所說,我們很高興能帶著新的擴展資料集回到那裡。

  • Operator

    Operator

  • Vikram Purohit, Morgan Stanley.

    維克拉姆‧普羅希特,摩根士丹利。

  • Unidentified Participant 5

    Unidentified Participant 5

  • Hi, this is Morgan on for Vikram. Thanks for taking your question. So I wanted to ask about your anticipation of the initial launch ramp curves and the third-line setting and how this might compare to late-line setting uptake. Thank you.

    大家好,我是維克拉姆的摩根。感謝您提出問題。所以我想問一下您對初始啟動斜坡曲線和第三線設定的預期,以及這與後期設定的採用情況相比如何。謝謝。

  • Chip Baird - CEO

    Chip Baird - CEO

  • Hi, Morgan. Thanks. So thanks for the question. On the fixed line launch was a different dynamic in the sense that there were patients with no treatment options. There was clearly a bolus of patients who had been waiting for that approval and capacity was limited.

    嗨,摩根。謝謝。謝謝你的提問。固定線路的推出是一種不同的動態,因為有些患者沒有治療選擇。顯然有大量患者一直在等待批准,但容量有限。

  • And so that resulted in long lines in terms of wait times and just triage in the best that we could as a manufacturer and as a sponsor from today, until I'd say, very different dynamics on more treatment options for those patients, a much larger market.

    因此,從今天起,這導致等待時間排得很長,並且我們作為製造商和贊助商盡最大努力進行分類,直到我想說,為這些患者提供更多治療選擇的動態非常不同,更大的市場。

  • We have, as Vicki highlighted earlier on, based on the present demand unlimited capacity. And so that I think sets us up well to expand into that market. But it's not the same kind of bolus effect. We expanded expected in the fifth line. So again, as we said early days here, it will be on return to growth. But we expect given the lag time between enrollments, if and then revenue kind of the revenue impact we don't expect to be able to show until we get into the second half of the year results, Q3, Q4 results.

    正如 Vicki 之前所強調的那樣,我們擁有基於當前需求的無限產能。因此,我認為這使我們能夠很好地擴展到該市場。但這不是同一種推注效應。我們擴大了第五線的預期。因此,正如我們早些時候所說,經濟將恢復成長。但我們預計,考慮到註冊之間的滯後時間,如果然後是收入影響,我們預計要等到下半年的結果、第三季、第四季的結果才能顯示出來。

  • Operator

    Operator

  • John Newman, Canaccord Genuity.

    約翰紐曼,Canaccord Genuity。

  • John Newman - Analyst

    John Newman - Analyst

  • Thanks for the question and congrats on the really great work that was done for the FDA panel. It was a tough one, but I can tell you were very well prepared and just had a question we've been hearing from some of the physicians at academic centers that they are devoting more resources over time to the Far East this portion of treatment.

    感謝您提出問題,並祝賀 FDA 小組所做的出色工作。這是一個艱難的過程,但我可以告訴你們,你們已經做好了充分的準備,並且我們剛剛從學術中心的一些醫生那裡聽到了一個問題,即隨著時間的推移,他們將在遠東的這在部分治療中投入較多的資源。

  • And some of them have sort of suggested that maybe in the future in conjunction with some of the companies perhaps some of that resource could be done off-site and not in the academic centers are just wanted to get your thoughts on that and whether it's something that you're sort of considering in conjunction with Bristol as we go forward.

    他們中的一些人建議,也許將來與一些公司合作,也許其中一些資源可以在場外而不是在學術中心完成,只是想了解您對此的想法以及是否有什麼東西在我們前進的過程中,您正在考慮與布里斯托爾一起考慮。

  • Chip Baird - CEO

    Chip Baird - CEO

  • Yes, John, thanks for the question. And then come up and FDA. We're certainly excited, as you said, with the team's performance there on the guide, it's anytime you solve a bottleneck that nuance created a supply chain as complex as CAR T therapy.

    是的,約翰,謝謝你的提問。然後上來FDA。正如您所說,我們當然很興奮,根據指南中團隊的表現,您可以隨時解決因細微差別而產生的像 CAR T 療法一樣複雜的供應鏈的瓶頸。

  • And so I think with the approval of suspension vector with the amount of capacity that we've been able to establish consistently on the drug product side on and you start to think about other bottlenecks, and that could be the number of beds in the clinic that could be a risk, a services capacity. These are all things that collectively as an industry we're thinking about.

    因此,我認為,隨著懸浮載體的批准以及我們能夠在藥品方面一致建立的容量,您開始考慮其他瓶頸,這可能是診所的床位數量這可能是一種風險,一種服務能力。這些都是我們作為一個行業正在考慮的所有事情。

  • And to the extent that we can influence on. We are those are ultimately decisions that make are made by the academic centers and hospitals, et cetera. But it's all part of the broader ecosystem. We've been playing a leading role there for some time.

    在我們可以影響的範圍內。我們最終的決定是由學術中心和醫院等做出的。但這都是更廣泛的生態系統的一部分。一段時間以來,我們一直在那裡發揮主導作用。

  • And we're going to continue to work to make access and availability for us for as many patients who can benefit here as we can. And we think that's that's a big number and we're going to be out of for quite some time on. I don't know if you have any additional thoughts on that one.

    我們將繼續努力為盡可能多的患者提供訪問和可用性,讓他們能夠在這裡受益。我們認為這是一個很大的數字,我們將在相當長的一段時間內缺席。不知道您對此還有什麼補充的想法嗎?

  • Vicki Eatwell - CFO

    Vicki Eatwell - CFO

  • Thank you, Chip. I think you answered that very well.

    謝謝你,奇普。我認為你回答得很好。

  • Operator

    Operator

  • 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。目前我沒有提出任何進一步的問題。我想將電話轉回給奇普·貝爾德(Chip Baird),讓他發表結束語。

  • Chip Baird - CEO

    Chip Baird - CEO

  • I thank you all for calling in today. If you have questions, we're happy to follow up further and look forward to them continuing to get after the return to growth for Beckman here throughout the balance of the year. Thanks, everyone. Have a great day.

    我感謝大家今天打電話來。如果您有疑問,我們很樂意進一步跟進,並期待他們在今年餘下的時間裡繼續關注貝克曼恢復增長的情況。感謝大家。祝你有美好的一天。

  • Operator

    Operator

  • 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。