2Seventy Bio Inc (TSVT) 2024 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good day and thank you for standing by. Welcome to the 2Seventy Bio second quarter 2024 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 with 2seventy Bio. Please go ahead.

    美好的一天,感謝您的支持。歡迎參加 2Seventy Bio 2024 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。我現在想將今天的會議交給您的發言人、2seventy Bio 的 Jenn Snyder。請繼續。

  • Jenn Snyder - Senior VP, Corporate Affairs

    Jenn Snyder - Senior VP, Corporate Affairs

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

    謝謝接線員,大家早安。感謝您加入我們。今天上午,我們發布了有關 2024 年第二季財務業績的新聞稿。新聞稿可在本公司網站 2seventybio.com 的投資者與媒體部分找到。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 include statements 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 applications for Abecma and statements regarding our financial conditions, expectations and 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, Quarterly Reports and other SEC filings.

    這些前瞻性陳述包括有關我們的策略計劃、時間表和對Abecma 的銷售、功效和感知治療益處的預期的陳述、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、預期和未來的陳述財務績效等。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、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. 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。請您注意不要過度依賴這些前瞻性陳述,除非法律要求,我們不承擔更新或修改任何前瞻性陳述的義務。

  • On today's call, we are joined by Chip Baird, Chief Executive Officer; and Vicki Eatwell, Chief Financial Officer; Anna Truppel-Hartman, Chief Medical Officer, is also on the line for questions during the Q&A. And now I will turn it over to Chip. Chip?

    執行長 Chip Baird 也參加了今天的電話會議;財務長 Vicki Eatwell;首席醫療官安娜·特魯佩爾-哈特曼 (Anna Truppel-Hartman) 也在問答環節中回答問題。現在我將把它交給奇普。晶片?

  • William Baird - Chief Executive Officer

    William Baird - Chief Executive Officer

  • Thank you, Jenn, and thank you all for joining this morning. Today, we disclosed our second 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 年第二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。

  • At the beginning of 2024, we took the strategic decision to focus 2seventy exclusively on Abecma and the commercial business. While it was not an easy or risk-free decision, we continue to believe it was the right one given the situation.

    2024 年初,我們做出策略決策,將 2seventy 專注於 Abecma 和商業業務。雖然這不是一個容易或無風險的決定,但我們仍然相信,鑑於目前的情況,這是正確的決定。

  • This quarter, we're beginning to see the positive impact of this major strategic pivot. We're controlling what we can control and are accomplishing what we set out to do; strengthening our financial position, streamline our cost structure and dedicating our resources to driving growth for Abecma.

    本季度,我們開始看到這一重大戰略支點的正面影響。我們正在控制我們能夠控制的事情,並且正在完成我們打算做的事情;加強我們的財務狀況,簡化我們的成本結構,並投入我們的資源來推動 Abecma 的成長。

  • We succeeded in dramatically reducing our cost structure and have also strengthened the balance sheet in the second quarter with $43 million in proceeds from the sale of our oncology R&D business to Regeneron in April and the sale of our hemophilia A program and related megaTAL technology to Novo Nordisk in June.

    我們成功地大幅降低了成本結構,並在第二季度強化了資產負債表,4 月份將我們的腫瘤研發業務出售給Regeneron 以及將我們的血友病A 項目和相關megaTAL 技術出售給Novo 獲得了4300萬美元的收益六月的諾德。

  • The Novo deal was another important strategic transaction in our effort to further streamline and focus the business. We are grateful to the 2seventy team members who have since transitioned to Novo Nordisk and thank them for their incredible work.

    Novo 交易是我們進一步精簡和集中業務的另一個重要策略交易。我們感謝自此轉入諾和諾德的 270 名團隊成員,並感謝他們所做的出色工作。

  • The changes that we have enacted enable us to focus 100% of our effort and energy on Abecma and I'm pleased to report that Abecma performance in the US turned a corner in the second quarter following the FDA's approval to treat earlier line patients. As expected and as previously guided, we achieved modest growth in revenue in the second quarter as we initiated our third line launch.

    我們所實施的變革使我們能夠將 100% 的努力和精力集中在 Abecma 上,我很高興地報告,在 FDA 批准治療早期患者後,Abecma 在美國的業績在第二季度出現了好轉。正如預期和先前的指導,隨著我們啟動第三條線,我們在第二季度實現了收入的小幅成長。

  • As we've previously shared, there's roughly a two-month lag between the time we enroll a patient and the time that patient receives Abecma, and we recognize revenue. While revenue growth was modest, we were encouraged by the double-digit growth in patients undergoing apheresis, the first step in the Abecma process and a leading indicator of demand.

    正如我們之前所分享的,我們招募患者的時間和患者接受 Abecma 的時間之間大約有兩個月的滯後,我們確認了收入。雖然收入成長不大,但接受單採術的患者數量實現兩位數增長令我們感到鼓舞,這是 Abecma 流程的第一步,也是需求的領先指標。

  • We've also seen an increase in use among sites who have previously stopped prescribing Abecma. Additionally, our commercial and launch messaging on the efficacy of Abecma, a consistent safety profile, has been well received by providers.

    我們也發現先前停止開立 Abecma 處方的網站的使用量增加。此外,我們關於 Abecma 功效的商業和發布資訊以及一致的安全性已受到提供者的好評。

  • While it's too soon to say what the shape of the curve is in terms of the return to growth, these indicators support our ongoing belief that Abecma has an important role to play for patients living with myeloma.

    雖然現在判斷成長恢復曲線的形狀還為時過早,但這些指標支持了我們一直以來的信念,即 Abecma 對骨髓瘤患者可以發揮重要作用。

  • We've now entered the second half of the year, and the BMS and 2seventy teams remain focused on executing the third line launch of Abecma. Our launch is focused on clearly articulating the case for Abecma, namely a competitive efficacy profile that is reproduced in the real-world setting, a well-established and manageable safety profile and a rapid manufacturing turnaround time with high rates of in-spec product.

    現在已經進入下半年,BMS 和 2seventy 團隊仍專注於執行 Abecma 的三線上市。我們的發布重點是清楚地闡述 Abecma 的案例,即在現實環境中重現的具有競爭力的功效概況、完善且可管理的安全概況以及快速的製造週轉時間和高合格產品率。

  • With KarMMa-3 data in the label and real-world evidence that continues to mature, we believe we have competitive profile in earlier line triple class-exposed patients, which is the population with high unmet need.

    憑藉標籤中的 KarMMa-3 數據和不斷成熟的現實世界證據,我們相信我們在早期三類暴露患者(需求未得到滿足的人群)中具有競爭力。

  • We remain optimistic about Abecma's return to growth in the months to come. We'll get to Q&A shortly. But for now, I'll turn it over to Vicki to talk further about the second quarter results. Vicki?

    我們對 Abecma 在未來幾個月恢復成長仍持樂觀態度。我們很快就會進行問答。但現在,我將把它交給 Vicki,進一步討論第二季的表現。維姬?

  • Vicki Eatwell - Chief Financial Officer

    Vicki Eatwell - Chief Financial Officer

  • Thanks, Chip. Second Quarter of Abecma US revenues as reported by Bristol-Myers Squibb were $54 million, which was in line with our expectations and reflects ongoing expansion into the third-line setting. As Chip stated, we are seeing a number of growth indicators, and we look forward to delivering Abecma to an increased number of patients as we return to growth in the second half of the year.

    謝謝,奇普。根據百時美施貴寶報告,Abecma 美國第二季營收為 5,400 萬美元,符合我們的預期,並反映了向三線環境的持續擴張。正如 Chip 所說,我們看到了許多成長指標,隨著我們在下半年恢復成長,我們期待著向更多患者提供 Abecma。

  • As a reminder, we share equally in the profits or losses of the US Abecma business with BMS, and we record collaboration arrangement revenue or loss each quarter, which largely represents our 50% share of revenue, cost of goods sold and selling expenpses related to the US business. In the second quarter, we reported collaboration revenue of $4.4 million related to our collaboration with BMS.

    提醒一下,我們與 BMS 平均分享美國 Abecma 業務的利潤或虧損,並且我們每季記錄合作安排收入或虧損,這主要代表我們 50% 的收入份額、銷售成本和美國企業與 BMS 相關的銷售費用。第二季度,我們報告與 BMS 合作相關的合作收入為 440 萬美元。

  • Turning briefly to our cost structure. This quarter, we achieved a $28 million or 43% reduction in GAAP operating expenses versus the first quarter of 2024 or a $48 million, 57% reduction versus the same quarter last year, primarily driven by the completion of the sale of our Oncology R&D business to Regeneron at the beginning of the quarter and the streamlining of our operations beginning in the second half of 2023.

    簡要談談我們的成本結構。本季度,我們的GAAP 營運費用與2024 年第一季相比減少了2,800 萬美元,即43%,與去年同期相比減少了4,800 萬美元,即57%,這主要是由於我們完成了腫瘤研發業務的出售。 我們在本季初與 Regeneron 合作,並於 2023 年下半年開始精簡業務。

  • We expect operating expenses to continue to decline into 2025 as our small remaining team prioritizes identifying further efficiencies. We expect a revised net cash spend range of $40 million to $60 million in 2024, which is a reduction from our previously guided net cash spend range of $80 million to $100 million.

    我們預計營運費用將在 2025 年繼續下降,因為我們剩下的小團隊將優先考慮進一步提高效率。我們預計 2024 年修訂後的淨現金支出範圍為 4,000 萬美元至 6,000 萬美元,這比我們先前指導的 8,000 萬美元至 1 億美元的淨現金支出範圍有所減少。

  • Lastly, the income from the Novo transaction has helped us achieve profitability for the quarter with $24.9 million of GAAP net income. And while quarterly profitability is for now a onetime event, we continue to see a path to cash flow breakeven and profitability as soon as 2025.

    最後,Novo 交易的收入幫助我們在本季度實現了盈利,GAAP 淨利潤為 2,490 萬美元。雖然季度獲利目前只是一次性事件,但我們仍然認為最快到 2025 年就能實現現金流收支平衡和獲利。

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

    有了這個,我會把它轉回給奇普。

  • William Baird - Chief Executive Officer

    William Baird - Chief Executive Officer

  • Thanks, Vicki. As we close, I'll reiterate that we are encouraged by what we've accomplished so far this year and set up for the second half of '24. We've turned the corner with Abecma and continue to believe in its potential to make a meaningful impact for patients in the earlier line setting.

    謝謝,維基。在我們結束時,我要重申,我們對今年迄今為止所取得的成就以及為 24 年下半年所做的準備感到鼓舞。我們已經與 Abecma 度過了難關,並繼續相信它有潛力對早期治療的患者產生有意義的影響。

  • We are singularly focused on delivering more time for every myeloma patient that we are able to serve which, together with our partners at BMS, remains our top priority.

    我們特別專注於為我們能夠服務的每位骨髓瘤患者提供更多的時間,與 BMS 的合作夥伴一起,這仍然是我們的首要任務。

  • We will continue to carefully manage investor capital with a streamlined cost structure, we are focused on reaching breakeven and profitability. Together with the rest of the 2seventy team, we will stay focused on these priorities to drive shareholder value.

    我們將繼續以精簡的成本結構謹慎管理投資者資本,我們致力於實現損益平衡和獲利能力。我們將與 2seventy 團隊的其他成員一起,繼續專注於這些優先事項,以推動股東價值。

  • 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

  • Thank you. (Operator Instructions) Daina Graybosch, Leerink.

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

  • Daina Graybosch - Analyst

    Daina Graybosch - Analyst

  • I'd like to understand more of the nature of the type of patients or sites that are starting apheresis in the third line. Any color you can give for either of those that would help us understand the growth going forward would be great.

    我想更多地了解在第三線開始進行血漿分離術的患者或地點的類型的性質。如果你能為其中任何一個提供任何有助於我們了解未來成長的顏色,那就太好了。

  • William Baird - Chief Executive Officer

    William Baird - Chief Executive Officer

  • Thanks, Daina. I appreciate the question. In terms of the type of patients, it is a mix between third-line patients as well as later line, fourth, fifth line patients. It's hard for us to separate those out for reasons having to do with HIPAA and other privacy concerns, we'll have better understanding of that as we move forward. But we clearly believe we're seeing both late-line patients as well as starting to see the impact of these third-line patients.

    謝謝,戴娜。我很欣賞這個問題。從患者類型來看,既有三線患者,也有後期、四線、五線患者。由於與 HIPAA 和其他隱私問題有關的原因,我們很難將它們分開,隨著我們的前進,我們將對此有更好的理解。但我們清楚地相信,我們不僅看到了晚期患者,也開始看到這些三線患者的影響。

  • In terms of the sites, as we've said before, the major academic centers are the primary driver for us in terms of the business, in terms of the total patient volume. And there, we've been encouraged to see some of the sites that had previously gone a long time without writing an Abecma script coming back to Abecma to using that again. And again, I think that's a function of the broader label, the broader data set that we can detail against and the collective efforts of the BMS and 2seventy teams.

    就站點而言,正如我們之前所說,就業務和患者總量而言,主要學術中心是我們的主要驅動力。在那裡,我們很高興地看到一些以前很久沒有編寫 Abecma 腳本的網站又回到 Abecma 並再次使用該腳本。再說一次,我認為這是更廣泛的標籤、我們可以詳細說明的更廣泛的數據集以及 BMS 和 2seventy 團隊的集體努力的結果。

  • Operator

    Operator

  • Kelsey Goodwin, Guggenheim.

    凱爾西·古德溫,古根漢。

  • Kelsey Goodwin - Analyst

    Kelsey Goodwin - Analyst

  • Maybe could you just provide some more color on the strategies that you're using to differentiate safety and efficacy at these sites? And then maybe if I can get a quick follow-up. Could you provide some more color on the sales assumptions that underlie how you think about breakeven for 2seventy?

    也許您可以就您用來區分這些網站的安全性和有效性的策略提供更多資訊嗎?然後也許我可以得到快速跟進。您能否提供更多關於銷售假設的信息,這些假設是您如何看待 2seventy 盈虧平衡的基礎?

  • William Baird - Chief Executive Officer

    William Baird - Chief Executive Officer

  • Sure. Kelsey, thanks for the questions there. I'll ask Anna to comment on the first question in terms of how we're detailing and describing and kind of the key points on safety, the efficacy and how we present Abecma. And then, Vicki, maybe you can comment on breakeven and what that could look like.

    當然。凱爾西,謝謝你的提問。我將請 Anna 對第一個問題發表評論,包括我們如何詳細描述和描述安全性、有效性以及我們如何展示 Abecma 的關鍵點。然後,Vicki,也許你可以評論一下盈虧平衡點以及它可能會是什麼樣子。

  • Anna, do you want to go ahead?

    安娜,你想繼續嗎?

  • Anna Truppel-Hartman - Chief Medical Officer

    Anna Truppel-Hartman - Chief Medical Officer

  • Yeah. Thanks so much, Chip. Thanks so much, Kelly. So for -- first of all, in KarMMa-3, Abecma show a significant superiority over standard of care with a very significant progression-free survival and all the other endpoints were significant as well across all subpopulations that we included in KarMMa-3. So we are clearly messaging on the consistent PFS benefit or efficacy benefit we have seen throughout all of our studies, including real world evidence that is very much consistent with what we're seeing in the clinical trial.

    是的。非常感謝,奇普。非常感謝,凱利。因此,首先,在KarMMa-3 中,Abecma 顯示出優於標準護理的顯著優勢,具有非常顯著的無進展生存期,並且所有其他終點在我們納入KarMMa-3 的所有亞群中也很顯著。因此,我們清楚地傳達了我們在所有研究中看到的一致的 PFS 益處或療效益處,包括與我們在臨床試驗中看到的非常一致的現實世界證據。

  • Also, it is important to note that -- and that was also part of the ODAC meeting, as you will remember, the bridging has gained much more importance over time. So that we are clearly messaging on the bridging therapy. How important it is to bridge patients prior to Abecma infusion because based on our KarMMa-3 data, we have seen greater outcomes or better outcomes influenced by decreased disease burden at time of infusion, which is influenced by the bridging therapy and those data were presented last IMS that showed this.

    另外,值得注意的是,這也是 ODAC 會議的一部分,您會記得,隨著時間的推移,橋樑變得越來越重要。這樣我們就可以清楚地傳達有關橋接療法的訊息。在Abecma 輸注之前橋接患者非常重要,因為根據我們的KarMMa-3 數據,我們發現輸注時疾病負擔減輕會帶來更好的結果或更好的結果,而輸注時疾病負擔的減輕又受到橋接療法的影響,並且提出了這些數據上次 IMS 顯示了這一點。

  • And we have even seen a medium PFS of 20.7 months in those patients who had decreased disease burden post -- with post bridging and prior Abecma. So that's the second message. So we are clearly messaging on efficacy that is further enhanced with optimized bridging therapy that is in the real world even easier because in the earlier line setting there are more options available for bridging.

    我們甚至發現那些在橋接後和先前 Abecma 治療後疾病負擔減輕的患者的中位無惡化存活期 (PFS) 為 20.7 個月。這是第二條訊息。因此,我們清楚地傳達了透過優化橋接療法進一步增強療效的訊息,這在現實世界中甚至更容易,因為在早期的線路設定中,有更多的橋接選項可供選擇。

  • And last, but not least, is the safety profile. We -- as seen in our USPI but also in every single data set we are publishing, the safety profile is well manageable, consistent throughout with low numbers and very, very low frequency of these delayed neurotoxicities such as Parkinson's or GPS. We didn't see anything in KarMMa-3. And we do believe we have otherwise as well a very compelling safety profile with Abecma. So taking the efficacy and the safety together, we do believe we have a very strong profile. Yeah, that's combined with a very reliable manufacturing process as well.

    最後但並非最不重要的一點是安全性。正如我們在 USPI 以及我們發布的每個資料集中所看到的,安全狀況是易於管理的,始終一致,這些遲發性神經毒性(如帕金森氏症或 GPS)的數量很少且頻率非常低。我們在 KarMMa-3 中沒有看到任何東西。我們確實相信 Abecma 在其他方面也具有非常引人注目的安全性。因此,將功效和安全性結合起來,我們確實相信我們擁有非常強大的形象。是的,這也與非常可靠的製造流程相結合。

  • I don't know if anyone wants to add something to the messaging.

    不知道有沒有人想在訊息中加入一些內容。

  • William Baird - Chief Executive Officer

    William Baird - Chief Executive Officer

  • Anna, well said. And then, Vicki, over to you on the question around breakeven.

    安娜,說得好。然後,維琪,關於損益平衡的問題就交給你了。

  • Vicki Eatwell - Chief Financial Officer

    Vicki Eatwell - Chief Financial Officer

  • Yeah. Thanks, Kelsy, for your question. So in terms of underlying sales assumptions for breakeven, we've guided in the past that we believe total US sales of less than $400 million makes us breakeven as a total company. So obviously, we're continuing to tighten 2seventy internal OpEx as we head into the end of the year and then into 2025. And so it doesn't take much for us to become breakeven as a holdco given the amount of cost savings that we're delivering this year.

    是的。謝謝凱爾西的提問。因此,就盈虧平衡的基本銷售假設而言,我們過去曾指導過,我們認為美國總銷售額低於 4 億美元將使我們作為一家整體公司實現盈虧平衡。顯然,隨著我們進入年底和 2025 年,我們將繼續收緊 270 內部營運支出。 因此,考慮到我們節省的成本,作為控股公司,我們不需要太多就能實現盈虧平衡。

  • Operator

    Operator

  • Vikram Purohit, Morgan Stanley.

    維克拉姆‧普羅希特,摩根士丹利。

  • Unidentified Participant

    Unidentified Participant

  • This is Morgan on for Vikram. So I wanted to understand a bit more context on the early experience for the 3L launch for Abecma, particularly with regards to volume of patients in this setting that have been treated with Abecma to date and how the slope of the 3L uptake curve compared to the later line launch curve you initially experienced.

    這是摩根替維克拉姆上場。因此,我想了解更多有關 Abecma 3L 推出的早期經驗的背景信息,特別是迄今為止接受 Abecma 治療的患者數量以及 3L 攝取曲線與 3L 攝取曲線相比的斜率如何您最初經歷的後來的線啟動曲線。

  • William Baird - Chief Executive Officer

    William Baird - Chief Executive Officer

  • Morgan, thanks for the question there. I think a little bit of the answer is going to be stay tuned. And when we're able to report third quarter results in October, late October when BMS has their earnings and our call shortly thereafter, we can get into it more.

    摩根,謝謝你的提問。我認為部分答案將繼續關注。當我們能夠在 10 月報告第三季業績時,即 10 月底,當 BMS 公佈其收益以及不久後我們的電話會議時,我們可以進一步了解這一點。

  • But certainly, the growth in apheresis that we saw in the second quarter, which is meaningful growth, double-digit growth should -- will pull-through into revenue growth here in the third quarter. So we'll be able to much better define the slope of that curve and how that curve should continue to change over time when we are on the same call three months from now.

    但可以肯定的是,我們在第二季度看到的單採術成長是有意義的成長,兩位數的成長應該會在第三季帶動收入成長。因此,當我們在三個月後進行同一個通話時,我們將能夠更好地定義該曲線的斜率以及該曲線應如何隨時間繼續變化。

  • But I think the early experience, as we've characterized, has been a positive one, an encouraging one. We have seen green shoots as measured by the growth in AFS, the additional sites kind of coming back to Abecma, the interactions that we've had with treating physicians and just a much broader dataset to detail in a much larger patient population.

    但我認為,正如我們所描述的那樣,早期的經歷是積極的、令人鼓舞的。我們已經看到了復甦的苗頭,透過 AFS 的成長來衡量,Abecma 的其他網站有點回歸,我們與治療醫生的互動以及更廣泛的數據集來詳細說明更大的患者群體。

  • And the last thing I'll say is that it is a different market than it was when we launched in the fifth line as the first commercial approved CAR-T and BCMA directed therapy where there was a big bolus there are patients waiting. This is a much more fluid, much more dynamic market, much bigger market, which again, I think, plays to our favor and plays to some of the belief that Vicki was just detailing in terms of it doesn't take much for us to breakeven or better with this larger third-line label. So more to come there, but I think the signs we've seen give us a lot of reason to be optimistic about the curve.

    我要說的最後一件事是,現在的市場與我們作為第一個商業批准的 CAR-T 和 BCMA 定向療法在第五線推出時不同,當時有大量的推注,有患者在等待。這是一個更流動、更有活力的市場,更大的市場,我認為這再次對我們有利,並且符合維基只是詳細說明的一些信念,我們不需要太多時間就能這個更大的三線品牌可以實現損益平衡或更好。所以還會有更多的事情發生,但我認為我們看到的跡象給了我們很多理由對曲線持樂觀態度。

  • Operator

    Operator

  • Salveen Richter, Goldman Sachs.

    薩爾文·里克特,高盛。

  • Unidentified Participant

    Unidentified Participant

  • This is (inaudible) on for Salveen. Just in case you might have missed this earlier on the call, when might you start providing guidance around Abecma sales. And is there -- do you have any updates around the timing for the Regeneron led pipeline assets and the next type data readout there?

    這是 Salveen 的(聽不清楚)。萬一您可能在早些時候的電話會議中錯過了這一點,您什麼時候可以開始提供有關 Abecma 銷售的指導。關於再生元領導的管道資產和下一個類型的數據讀出的時間安排,您有任何更新嗎?

  • William Baird - Chief Executive Officer

    William Baird - Chief Executive Officer

  • Yeah. Thanks for those questions. I can take those. In terms of guidance, we haven't provided revenue guidance. I think we want to get a couple of quarters into the launch before we start to guide specifically there. So stay tuned. But we're not guiding on that one at this time.

    是的。謝謝你提出這些問題。我可以接受那些。在指導方面,我們尚未提供收入指導。我認為我們希望在發布後幾季再開始具體指導。所以請繼續關注。但我們目前不會就這一問題提供指導。

  • And then from a Regeneron oncology assets that went to the Regeneron cell medicines business, that's more their products now. So we don't have direct visibility or control over those anymore. We do have downstream participation in terms of commercial and late-stage milestones, but that's not going to be a factor for us in certainly the next couple of quarters.

    然後,再生元腫瘤學資產轉移到再生元細胞藥物業務,現在更多的是他們的產品。因此,我們不再能夠直接查看或控制這些內容。在商業和後期里程碑方面,我們確實有下游參與,但這肯定不會成為我們未來幾季的一個因素。

  • Really, the story there was moving those assets, those people, those real estate into fertile soil with Regeneron and the longer-term capital base that they have. So that's what we've done. And again, as we said at the top of the call, that streamlines our approach so we can focus exclusively on unlocking value with Abecma.

    事實上,那裡的故事正在將這些資產、那些人、那些房地產轉移到再生元和他們擁有的長期資本基礎的肥沃土壤中。這就是我們所做的。正如我們在電話會議開頭所說,這簡化了我們的方法,使我們能夠專注於透過 Abecma 釋放價值。

  • Operator

    Operator

  • Yaron Werber, Cowen.

    亞龍·韋伯,考恩。

  • Unidentified Participant

    Unidentified Participant

  • This is Jana on for Yaron. A follow-up on the previous question asking about the types of patients that started apheresis in Q2. Are you hearing from physicians that there are any specific subsets of multiple myeloma patients that would preferentially receive Abecma rather Carvykti or a bispecific?

    我是雅娜 (Jana) 代表亞龍 (Yaron)。上一個問題的後續問題,詢問第二季開始血漿分離術的患者類型。您是否從醫生那裡聽說,有任何特定的多發性骨髓瘤患者亞群會優先接受 Abecma 而不是 Carvykti 或雙特異性藥物?

  • William Baird - Chief Executive Officer

    William Baird - Chief Executive Officer

  • No, thanks for the question, Jana. I think it's a broad spectrum. As you said, it's third-line patients. It's later line patients. One of the things that I think is something we're hearing about is just safety candidly. And I think the risk with a sector of some of the more severe neurotox, the risk of Parkinson's is something that weighs heavily, particularly for sites that have experienced one of those cases.

    不,謝謝你的提問,賈娜。我認為這是一個廣泛的範圍。正如你所說,這是三線患者。後面就是排隊病人了。坦白說,我認為我們聽到的其中一件事就是安全。我認為一些更嚴重的神經毒素的風險,帕金森氏症的風險是很重要的,特別是對於經歷過其中一種情況的場所。

  • And so again, there, I think we have differentiated safety profile. And so that's one that we hear about. But again, I think it's early days there, and we'll start to understand better -- more the split of patients and the third line or the later line as we move through the launch. But I'll ask Anna to see if there's anything to add there in terms of what we're hearing from treating physicians.

    再說一次,我認為我們有差異化的安全狀況。這就是我們所聽到的。但同樣,我認為現在還處於早期階段,隨著我們的推出,我們將開始更好地了解患者和第三線或後來線的劃分。但我會請安娜看看根據我們從主治醫生那裡聽到的情況是否有任何需要補充的內容。

  • Anna Truppel-Hartman - Chief Medical Officer

    Anna Truppel-Hartman - Chief Medical Officer

  • Yeah. Thank you, Chip. So I would like to repeat again that all patients in our clinical trials as well as real world evidence benefit from the use of Abecma. So there is no subgroup that have shown a better outcome or worse outcome. That's why every patient can benefit. So that's also something that to be keep in mind.

    是的。謝謝你,奇普。因此,我想再次重申,我們臨床試驗中的所有患者以及現實世界的證據都受益於 Abecma 的使用。因此,沒有哪個亞組表現出更好或更差的結果。這就是為什麼每個患者都能受益。所以這也是需要記住的事情。

  • There is also the fact that also in previous conferences, clearly it was recommended to use the CAR-T prior to TCEs. And so whenever a patient can access and can receive a CAR-T or CAR-Ts given prior to a TCE, and that's kind of what we are hearing throughout all of the KOLs and all of the conferences that are where the sequencing questions, et cetera, are being discussed.

    還有一個事實是,在先前的會議上,也明確建議在 TCE 之前使用 CAR-T。因此,每當患者可以訪問並接受在 TCE 之前給予的 CAR-T 或 CAR-T 時,這就是我們在所有 KOL 和所有會議中聽到的內容,這些會議涉及測序問題等等等,正在討論中。

  • And finally, it's also a patient's choice and safety matters a lot, especially in earlier lines, as Chip already mentioned, the low -- very low frequency of Parkinson's and also the well manageable safety profile is compelling for many physicians and patients, which also guides decision-making.

    最後,這也是患者的選擇,安全性也很重要,特別是在早期的產品線中,正如Chip 已經提到的那樣,帕金森氏症的低——非常低的頻率以及易於管理的安全性對許多醫生和患者來說都是引人注目的,這也指導決策。

  • Operator

    Operator

  • Daina Graybosch, Leerink.

    戴娜·格雷博斯,萊林克。

  • Daina Graybosch - Analyst

    Daina Graybosch - Analyst

  • I think for the follow-up, we're talking a lot about safety and I wonder -- this question is for Anna. As we see more data with Abecma in the real world and with other CAR-T programs, if you have any updated view on what underlies the Abecma differential safety versus the competing product? And is it just Parkinsonism or the other of the neurotox, the lower grade that doctors are talking about? And are those meaningful to their choice to Abecma as well? I'm wondering which one specifically.

    我認為對於後續行動,我們談論了很多關於安全的問題,我想知道——這個問題是問安娜的。隨著我們在現實世界中看到更多 Abecma 以及其他 CAR-T 項目的數據,您是否對 Abecma 與競爭產品的安全性差異有任何最新看法?這只是帕金森氏症還是另一種神經毒素,即醫生所說的較低程度的神經毒素?這些對 Abecma 的選擇也有意義嗎?我想知道具體是哪一個

  • Anna Truppel-Hartman - Chief Medical Officer

    Anna Truppel-Hartman - Chief Medical Officer

  • Yeah. Thank you, Daina. A very good question. So first of all, I'd like to say that, of course, real world evidence data are coming in day after day. And so we are always assessing everything that is published and everything that comes in and looking at that.

    是的。謝謝你,戴娜。這是一個很好的問題。首先,我想說,當然,現實世界的證據數據日復一日地出現。因此,我們總是評估已發布的所有內容和收到的所有內容並進行研究。

  • In addition to that, of course, we are looking at our own safety database, where we are collecting all the adverse events and we are also collecting of course those events specifically and looking at that. And so all of the events that we are seeing is really like -- this ICANS neurotoxicity, I think that's very well published and also characterized. I don't think that there is a huge difference between CARs that we are knowing at this point in time. It's specifically the debate, neurotoxicities, which also includes several policy, et cetera.

    除此之外,當然,我們正在查看我們自己的安全資料庫,我們正在其中收集所有不良事件,當然我們也正在專門收集這些事件並進行研究。因此,我們所看到的所有事件都非常像——ICANS 神經毒性,我認為這已經得到很好的發表並且也得到了描述。我不認為我們目前所知的 CAR 之間存在巨大差異。具體來說,這是關於神經毒性的爭論,其中還包括一些政策等等。

  • And there's also an effect of A, the terminology is a bit of a confusing fact and you're right there that there needs to be more correct, better characterization which events you're really talking about. But in general, everything that is non-ICANS neurotoxicity seems to be at a very low frequency for Abecma compared to other products.

    還有 A 的影響,術語有點令人困惑,你就在那裡,需要更正確、更好地描述你真正談論的事件。但總的來說,與其他產品相比,Abecma 出現非 ICANS 神經毒性的頻率似乎非常低。

  • Does this answer your question, Daina?

    這能回答你的問題嗎,戴娜?

  • Operator

    Operator

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

    謝謝。目前我不會再提出任何問題。我想將電話轉回給奇普·貝爾德(Chip Baird),讓他發表結束語。

  • William Baird - Chief Executive Officer

    William Baird - Chief Executive Officer

  • Thank you, and thanks, everyone, for making time for the call today. We continue to focus on execution and returning Abecma to growth. We're available for follow-up with analysts and investors throughout the day, and we look forward to seeing everyone again on our third quarter earnings call and sharing the latest results there for Abecma. Have a great day.

    謝謝大家,謝謝大家今天抽空來參加電話會議。我們繼續專注於執行力和讓 Abecma 恢復成長。我們整天都可以與分析師和投資者進行跟進,我們期待在第三季財報電話會議上再次見到大家,並在那裡分享 Abecma 的最新業績。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。