Teva Pharmaceutical Industries Ltd (TEVA) 2024 Q2 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

  • Hello.

    你好。

  • And welcome to the Teva Pharmaceuticals Industries Limited Q2 2024 earnings call.

    歡迎參加梯瓦製藥工業股份有限公司 2024 年第二季財報電話會議。

  • My name is Alex.

    我叫亞歷克斯。

  • And I'll be coordinating the call today.

    今天我將協調電話會議。

  • (Operator Instructions)

    (操作員說明)

  • I'll now hand it over to your host, Ran Meir, SVP, Head of Investor Relations.

    現在我將把它交給主持人、高級副總裁兼投資者關係主管蘭·梅爾 (Ran Meir)。

  • Please go ahead.

    請繼續。

  • Ran Meir - Senior Vice President, Head of Investor Relations and Corporate Communications

    Ran Meir - Senior Vice President, Head of Investor Relations and Corporate Communications

  • Thank you, Alex.

    謝謝你,亞歷克斯。

  • And thank you, everyone, for joining us today.

    感謝大家今天加入我們。

  • We hope you have had a chance to review our Q2 results press release, which was issued earlier this morning.

    我們希望您有機會閱讀今天早上早些時候發布的第二季業績新聞稿。

  • Copy of the press release, along with the slides presented during this call, are available on our website at ir.tevapharm.com.

    新聞稿的副本以及本次電話會議期間演示的幻燈片可在我們的網站 ir.tevapharm.com 上取得。

  • Please review our forward-looking statements on slide 2.

    請查看投影片 2 上的前瞻性陳述。

  • Additional information regarding these statements and the non-GAAP financial measures is available on our earnings release and in our SEC Forms 10-K and 10-Q.

    有關這些報表和非 GAAP 財務指標的更多信息,請參閱我們的收益報告以及 SEC 表格 10-K 和 10-Q。

  • To begin today's call, Richard Francis, Teva's CEO, will provide an overview of Teva's second quarter business performance, recent events, and focus and priorities going forward.

    在今天的電話會議中,Teva 執行長 Richard Francis 將概述 Teva 第二季度的業務業績、近期事件以及未來的重點和優先事項。

  • Then, Dr. Eric Hughes, our Head of R&D and Chief Medical Officer, will discuss progress on our innovative pipeline.

    然後,我們的研發主管兼首席醫療官 Eric Hughes 博士將討論我們創新管道的進展。

  • Our CFO, Eli Kalif, will follow up by reviewing the second quarter financial results and our updated financial outlook in more detail.

    我們的財務長 Eli Kalif 隨後將更詳細地審查第二季的財務表現和我們更新的財務前景。

  • Please note that today's call will run approximately one hour.

    請注意,今天的通話將持續約一小時。

  • And with that, I will now turn the call over to Richard.

    現在,我將把電話轉給理查德。

  • Richard, if you would, please?

    理查德,你願意嗎?

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Thank you, Ran.

    謝謝你,蘭。

  • And good morning, everybody.

    大家早安。

  • And thank you for joining us on our Q2 2024 earnings call.

    感謝您參加我們的 2024 年第二季財報電話會議。

  • So I'd like to start by talking to you about the Pivot to Growth strategy, and it's just over a year since we launched this Pivot to Growth strategy.

    因此,我想先與大家談談「以成長為中心」策略,距離我們推出「以成長為中心」策略才剛剛一年多。

  • And as you know, the foundation of it was four pillars: deliver on our growth engine, step up innovation, sustain generics powerhouse, and focus the business.

    如您所知,它的基礎是四個支柱:提供我們的成長引擎、加強創新、維持仿製藥強國以及專注於業務。

  • And I'm pleased to say we've made great progress over the last year.

    我很高興地說我們在去年取得了巨大進步。

  • Deliver on our growth engines, we have driven -- we continue to drive AUSTEDO and UZEDY and AJOVY from a revenue point of view, and I'm pleased to say that we've launched SIMLANDI, our biosimilar Humira.

    從收入的角度來看,我們已經推動了我們的成長引擎,我們將繼續推動 AUSTEDO、UZEDY 和 AJOVY,我很高興地說我們已經推出了 SIMLANDI,我們的生物仿製藥 Humira。

  • With regards to step-up innovation, Eric and his team have done a great job in bringing this pipeline through quickly.

    在逐步創新方面,埃里克和他的團隊在快速推進這條管道方面做得非常出色。

  • We're pleased to say that Olanzapine is now at 95% of target injections completed with no PDSS.

    我們很高興地說,奧氮平現在已在沒有 PDSS 的情況下完成了 95% 的目標注射。

  • And also, there's some good news on TL1A, with the acceleration of that and top line results expected in Q4 this year.

    此外,TL1A 也有一些好消息,預計今年第四季將加速實現頂線業績。

  • Eric will also start to highlight a bit more about ICS/SABA.

    Eric 也將開始重點介紹有關 ICS/SABA 的更多資訊。

  • And we're pleased to introduce the new member of our pipeline family, a treatment for MSA, where we'll go into in more detail later on.

    我們很高興向大家介紹我們管道家族的新成員,即 MSA 的治療方法,稍後我們將對此進行更詳細的介紹。

  • On the third pillar, sustained generics powerhouse, as you'll see, we've made -- continue to make good progress here as well, with good growth across all regions.

    在第三個支柱上,正如您將看到的,我們已經取得了持續的仿製藥強國——繼續在這裡取得良好進展,所有地區都取得了良好的增長。

  • And then, finally focusing our business and our capital allocation, with regards to TAPI, we have the second quarter of revenue growth, and we're well on our way with the process of divestment there, which I'll go into in a bit more detail later on.

    然後,最後重點關注我們的業務和資本配置,就 TAPI 而言,我們第二季度的收入成長,而且我們的撤資流程進展順利,我稍後會詳細介紹這一點稍後會詳細介紹。

  • So now, is the Pivot to Growth delivering on what we set out to do?

    那麼現在,「成長樞軸」計畫是否實現了我們的預期目標?

  • And as you can see by this slide, I believe it is.

    正如您從這張幻燈片中看到的,我相信確實如此。

  • We've had six quarters of continuous growth, culminating in the quarter two that we're going to walk you through today of a strong 11%.

    我們已經連續六個季度實現了持續成長,最終在第二季實現了 11% 的強勁成長。

  • So clearly, this strategy is helping the company align and get focused and drive revenue growth.

    顯然,這項策略正在幫助公司調整並集中精力並推動收入成長。

  • Now, to go into a bit more detail on these numbers, as you can see by this slide, revenue's up to $4.2 billion, 11%; adjusted EBITDA up to $1.2 billion, 4%; and our non-GAAP EPS up to $0.61, up 9%.

    現在,更詳細地了解這些數字,正如您在這張投影片中看到的那樣,收入高達 42 億美元,佔 11%;調整後 EBITDA 高達 12 億美元,成長 4%;我們的非 GAAP 每股盈餘達到 0.61 美元,成長 9%。

  • Because of these strong results, I'm pleased to announce that we're going to increase our guidance for the year, and that will be across revenue, EBITDA, and EPS.

    由於這些強勁的業績,我很高興地宣布,我們將提高今年的指導,這將涵蓋收入、息稅折舊攤銷前利潤 (EBITDA) 和每股盈餘 (EPS)。

  • And Eli will go into a bit more detail of the specifics of that, but, obviously, we're very pleased to announce that today.

    伊萊將更詳細地介紹具體細節,但顯然,我們今天非常高興地宣布這一點。

  • Now, going into a bit more detail as to what's driving that 11%, what I'm pleased, is that this has been driven across all of our businesses.

    現在,更詳細地說明推動這 11% 的因素,令我感到高興的是,這是我們所有業務的推動因素。

  • As you can see from this slide, our innovative business continues to perform well and grow quickly.

    正如您從這張幻燈片中看到的,我們的創新業務繼續表現良好並快速成長。

  • But, you'll also see that our generics business growing at 14% -- and I'll walk you through how this has grown across all regions -- is also a major contributor.

    但是,您還會看到我們的仿製藥業務以 14% 的速度成長——我將向您介紹這項業務在所有地區的成長情況——也是一個主要貢獻者。

  • And then finally, TAPI API growing at 5% means, once again, we've returned this business to growth and this is our second quarter of growth, and this gives us a lot of confidence for the rest of the year.

    最後,TAPI API 成長 5% 意味著我們再次讓這項業務恢復成長,這是我們第二季的成長,這給了我們對今年剩餘時間充滿信心。

  • Now, get into even more detail on some of these areas, starting with AUSTEDO.

    現在,從 AUSTEDO 開始,更詳細地了解其中一些領域。

  • Really excellent performance by AUSTEDO.

    AUSTEDO 的表演確實非常出色。

  • So congratulations to the team behind this.

    祝賀這背後的團隊。

  • Really proud of what you've done. $407 million of revenue, 32% of revenue growth, and TRX at a strong 30%.

    真的為你所做的事情感到自豪。營收 4.07 億美元,營收成長 32%,TRX 成長 30%。

  • And because of this good strong performance, we're raising guidance from $1.5 billion to $1.6 billion for the year.

    由於這種良好的強勁表現,我們將今年的指導從 15 億美元提高到 16 億美元。

  • So very pleased about the progress we've made on AUSTEDO.

    我們對 AUSTEDO 的進展感到非常高興。

  • Now, just to give you some updated news on AUSTEDO, we completed the family with regards to every dosage form having a once a day.

    現在,為了向您提供有關 AUSTEDO 的一些最新消息,我們完成了有關每種劑型每天一次的系列。

  • And this is a nice sort of completion of the circle and allows the patients who are titrating to have an even more simplistic dosing regimen.

    這是一個很好的循環,讓正在滴定的患者能夠有一個更簡單的給藥方案。

  • So congratulations for the team for bringing that to the market.

    祝賀我們的團隊將其推向市場。

  • As we move on to AJOVY, AJOVY continues to grow strongly at 12%, driven primarily by European business and the international markets.

    隨著我們轉向 AJOVY,AJOVY 繼續以 12% 的速度強勁增長,這主要是由歐洲業務和國際市場推動的。

  • But what I continue to be impressed with is the competitiveness of all of our regions.

    但令我印象深刻的是我們所有地區的競爭力。

  • We are growing market share across all of our regions, US, Europe, and international markets.

    我們在所有地區、美國、歐洲和國際市場的市場份額都在不斷增長。

  • As I've highlighted before, this just shows the quality of the team we have at Teva when it comes to driving these innovative products in even very competitive markets.

    正如我之前強調的,這恰恰表明了我們 Teva 團隊的素質,即使在競爭非常激烈的市場中,也能推動這些創新產品的發展。

  • Now, I'd like to move on to the newest member of our family, UZEDY.

    現在,我想談談我們家族的最新成員 UZEDY。

  • And we're very pleased with the momentum that that we have with UZEDY.

    我們對 UZEDY 的發展勢頭感到非常滿意。

  • What we're seeing is this really favorable product profile continues to attract new physicians and excite them.

    我們看到的是,這種非常有利的產品概況繼續吸引新的醫生並使他們興奮。

  • And as I've mentioned before, from a patient perspective, the subcutaneous needle is obviously something they welcome versus the IM.

    正如我之前提到的,從患者的角度來看,與 IM 相比,皮下針顯然更受他們歡迎。

  • But also, what we're not seeing is the practical nature of the administration, the fact that this product doesn't have to be kept refrigerated, but most importantly, that this can be administered to a patient and they receive -- get a therapeutic dose within 8 to 24 hours, and physicians love that.

    而且,我們沒有看到的是給藥的實用性,事實上該產品不必冷藏,但最重要的是,可以將其給藥於患者,他們會收到——得到一個8 至24 小時內即可達到治療劑量,醫生對此感到滿意。

  • And so this is what is allowing us to compete very effectively and to take market share in the risperidone long-acting market.

    因此,這使我們能夠非常有效地競爭並在利培酮長效市場中佔據市場份額。

  • So pleased with the progress we're making there and confident for the rest of the year.

    我們對在那裡取得的進展感到非常高興,並對今年剩餘的時間充滿信心。

  • Now, as I move on to the last part of the growth drivers, deliver on our first pillar and move on to the biosimilars.

    現在,當我繼續討論成長動力的最後一部分時,我們將實現我們的第一個支柱並繼續討論生物相似藥。

  • And as you know, we launched our SIMLANDI, our biosimilar Humira in Q2 of this year, and we're really pleased with the progress we've made.

    如您所知,我們在今年第二季度推出了 SIMLANDI,這是我們的生物仿製藥 Humira,我們對所取得的進展感到非常滿意。

  • We've fully stocked the channel.

    我們的頻道備貨充足。

  • We're getting good and growing coverage with our payers.

    我們的付款人的覆蓋範圍越來越廣。

  • And also, we set up a private label with Quallent.

    此外,我們也與 Quallent 建立了自有品牌。

  • So I think we are well set for this to generate some performance in Q3 and Q4 of this year.

    因此,我認為我們已經做好準備,可以在今年第三季和第四季取得一些業績。

  • But building on this, we were also pleased that we got approval from the FDA for our biosimilar of Stelara, and this will be launched in February 2025.

    但在此基礎上,我們也很高興我們的 Stelara 生物相似藥獲得了 FDA 的批准,並將於 2025 年 2 月上市。

  • But now we have approval, this gives us the opportunity to start to prepare for this launch in February 2025.

    但現在我們已經獲得批准,這讓我們有機會開始為 2025 年 2 月的發布做準備。

  • Now, it is worth pointing out on this slide also that as excited we are about these two products, we do have another five in the pipeline that are coming in the near term.

    現在,在這張投影片上也值得指出的是,儘管我們對這兩款產品感到興奮,但我們確實還有另外五個產品正在醞釀中,並將在短期內推出。

  • So as you can see that our biosimilar strategy is gaining momentum and it will contribute to the Pivot to Growth strategy and allow us to grow top and bottom line.

    正如您所看到的,我們的生物相似藥策略正在獲得動力,它將有助於成長策略,並使我們能夠實現營收和利潤的成長。

  • Now, moving on to the second pillar, step up innovation.

    現在,轉向第二支柱,加強創新。

  • Eric's going to talk a lot about this later, so I'll try not to steal any of his thunder.

    艾瑞克稍後會詳細討論這個問題,所以我會盡量不搶他的風頭。

  • What I will do is just highlight the significant progress that has been made.

    我要做的只是強調已經取得的重大進展。

  • This is now becoming a deep pipeline that's exciting.

    現在,這正在成為一條令人興奮的深層管道。

  • We'll talk a bit about Olanzapine and obviously TL1A, but it's nice to start to sort of see some data points in the future emerging on TL1A anti-PD1-IL2.

    我們將討論一些奧氮平,當然還有 TL1A,但很高興開始看到未來關於 TL1A 抗 PD1-IL2 的一些數據點。

  • We're also working hard to accelerate ICS/SABA, and as I said earlier, we are pleased that we're bringing a much needed medicine to the MSA community in a Phase 2 study that's starting later this year.

    我們還在努力加速 ICS/SABA,正如我之前所說,我們很高興在今年稍後開始的 2 期研究中為 MSA 社區帶來了急需的藥物。

  • So very excited about the work Eric and his team have done.

    對埃里克和他的團隊所做的工作感到非常興奮。

  • Now, I'm going to go into a couple of these assets to sort of highlight why we're excited about them from a commercial point of view.

    現在,我將介紹其中的一些資產,以強調為什麼我們從商業角度對它們感到興奮。

  • So starting with our ICC/SABA.

    那麼從我們的 ICC/SABA 開始。

  • As you can see, this is a big market.

    正如你所看到的,這是一個很大的市場。

  • There's 13 million people who suffer from asthma in the US and the recommendations of the guidelines, the GINA guidelines are that these people should be on a combination therapy.

    美國有 1300 萬人患有氣喘,GINA 指南建議這些人應該接受聯合治療。

  • So that excites us obviously because IC/SABA is a combination therapy, but what is interesting is we will be differentiated in the fact that we have a pediatric indication and a patient-friendly device.

    這顯然讓我們興奮,因為 IC/SABA 是一種聯合療法,但有趣的是,我們將因擁有兒科適應症和患者友好型設備而與眾不同。

  • Now, just to sort of give you some grounding on the numbers here from a pediatric indication, asthma is the most common chronic disease when it comes to children in the United States.

    現在,為了給您一些兒科適應症數據的基礎,氣喘是美國兒童最常見的慢性疾病。

  • It also accounts for more hospitalizations than any other chronic illness in this patient population.

    在該患者群體中,與任何其他慢性疾病相比,它導致的住院治療也更多。

  • So clearly, there's an opportunity for us to help these people, and that's what we're energized to do with ICS/SABA, hence we're trying to drive this to the market as quickly as possible.

    顯然,我們有機會幫助這些人,這就是我們對 ICS/SABA 所做的努力,因此我們正在努力盡快將其推向市場。

  • Now, another pipeline product that we're very excited about and there's a lot of discussion about is Olanzapine.

    現在,我們非常興奮並且有很多討論的另一個管道產品是奧氮平。

  • And the reason why we're excited about it is obviously the opportunity.

    我們對此感到興奮的原因顯然是機會。

  • There's a large market of $5 billion for long-acting anti-psychotics.

    長效抗精神病藥物有一個價值 50 億美元的龐大市場。

  • What's interesting is there is no long-acting Olanzapine that's used in any quantity at all, and that's because they haven't had the right product profile.

    有趣的是,長效奧氮平根本沒有以任何數量使用,這是因為他們沒有正確的產品簡介。

  • We believe in Olanzapine, our long-acting Olanzapine.

    我們相信奧氮平,我們的長效奧氮平。

  • We will have the product profile that has efficacy, safety, and tolerability all in one.

    我們將擁有集功效、安全性和耐受性為一體的產品概況。

  • It will also have similar attributes to UZEDY, which the ability to reach therapeutic doses quickly, so avoiding oral supplementation, so making it very user-friendly for the physician.

    它還具有與 UZEDY 類似的屬性,能夠快速達到治療劑量,從而避免口服補充劑,因此對醫生來說非常用戶友好。

  • And that's why we're seeing the excitement amongst the psychiatric community.

    這就是為什麼我們看到精神醫學界如此興奮。

  • So now moving on to our third pillar, which is creating a sustainable generics powerhouse.

    現在轉向我們的第三個支柱,即創建一個可持續的仿製藥強國。

  • So as you see here, 40% growth globally, but all regions contributing very strongly.

    正如您在這裡看到的,全球成長了 40%,但所有地區的貢獻都非常強勁。

  • Particularly pleased to see the US at 16%, but as you can see, 8% and 22% for international markets, strong growth across all of our regions.

    特別高興地看到美國成長了 16%,但正如您所看到的,國際市場成長了 8%,成長了 22%,我們所有地區都出現了強勁成長。

  • Now, moving on to TAPI, our final pillar of our strategy, which is focusing on capital.

    現在,我們轉向 TAPI,這是我們策略的最後一個支柱,重點是資本。

  • The aim was to get TAPI management team up and running and focused on driving this business.

    目的是讓 TAPI 管理團隊組建並運行,並專注於推動這項業務。

  • As I've said in the past, it's an $85 billion market.

    正如我過去所說,這是一個價值 850 億美元的市場。

  • We have a great business with TAPI, and the question is keeping it focused.

    我們與 TAPI 有著良好的業務往來,問題是保持專注。

  • Could we get it back to growth?

    我們能讓它恢復成長嗎?

  • We have done that for the second quarter.

    我們在第二季度就做到了這一點。

  • We've seen continued strong traction across the CDMO community.

    我們看到 CDMO 社群持續受到強烈關注。

  • And the divestment process is on track.

    撤資進程也已步入正軌。

  • And we're targeting completion by H1 in 2025.

    我們的目標是在 2025 年上半年完成。

  • So that concludes my presentation for today.

    我今天的演講就到此結束。

  • I'm going to hand over to Eric, who's going to walk you through that exciting pipeline that I spoke about.

    我將把任務交給艾瑞克(Eric),他將引導您完成我談到的令人興奮的流程。

  • Eric Hughes - Executive Vice President - Global R & D, Chief Medical Officer

    Eric Hughes - Executive Vice President - Global R & D, Chief Medical Officer

  • Thank you, Richard.

    謝謝你,理查。

  • Starting with our late-stage innovative pipeline, first I'd like to talk about anti-TL1A, our program in inflammatory bowel disease, also known as Duvakitug.

    從我們的後期創新管道開始,首先我想談談抗 TL1A,這是我們在發炎性腸道疾病(也稱為 Duvakitug)方面的計畫。

  • This is a study that we accelerated.

    這是我們加速進行的一項研究。

  • We randomized our last patient on July 5, and that gives us about a three-month at acceleration, which we're excited to say that we can now produce top line data in the fourth quarter of this year.

    我們在 7 月 5 日對最後一位患者進行了隨機分組,這給了我們大約三個月的加速時間,我們很高興地說我們現在可以在今年第四季度產生頂線數據。

  • Moving on to Olanzapine LAI, we've also accelerated this program by nine months, and we'll be presenting our Phase 3 data on the second half of this year at a conference so that we can review the exciting data we announced earlier this year.

    接下來是奧氮平LAI,我們還將該計劃加快了九個月,我們將在今年下半年的一次會議上展示我們的3 期數據,以便我們可以回顧今年早些時候宣布的令人興奮的數據。

  • Finally, ICS/SABA, our dual-action rescue inhaler that Richard mentioned, we're working very diligently to keep our Phase 3 study on time, which we're doing a good job right now and we're on target for our second half of 2026.

    最後,理查德提到的ICS/SABA,我們的雙作用救援吸入器,我們正在非常努力地工作,以確保我們的第3 階段研究按時進行,我們現在做得很好,並且我們正在實現第二階段的目標2026 年一半。

  • But as usual, we'll always work hard to accelerate that program as well.

    但與往常一樣,我們也將始終努力加速該計劃。

  • So an exciting late-stage program that we've got going here at Teva.

    這是我們在 Teva 正在進行的一項令人興奮的後期計劃。

  • Now, one of the things we announced this month as well is something that I'm particularly proud of is our AJOVY program in pediatrics.

    現在,我們本月宣布的讓我特別自豪的事情之一就是我們的兒科 AJOVY 計劃。

  • We finished our pediatric study in episodic migraine, the SPACE study, and this was a well-controlled robust study of approximately over 200 patients for treatment of eight weeks.

    我們完成了針對陣發性偏頭痛的兒科研究 SPACE 研究,這是一項對照良好的穩健研究,對大約 200 名患者進行了為期八週的治療。

  • And we're very pleased to say that we achieved primary and secondary endpoints that showed a significant reduction in our monthly migraine days compared to placebo.

    我們非常高興地說,我們實現了主要和次要終點,表明與安慰劑相比,我們每個月的偏頭痛天數顯著減少。

  • And this was very consistent with what we saw in the adult population, with no emergent safety signals.

    這與我們在成年人口中看到的情況非常一致,沒有出現緊急安全訊號。

  • So it's very encouraging to see in more fragile population, the safety and the efficacy continue to be shown for AJOVY.

    因此,看到 AJOVY 在更脆弱的人群中繼續顯示出安全性和有效性,這非常令人鼓舞。

  • We continue in our pediatric adolescent program in chronic migraine.

    我們持續進行針對慢性偏頭痛的兒科青少年計畫。

  • So we hope to someday bring this treatment to children around the world and our label, but more to come.

    因此,我們希望有一天能夠將這種治療方法帶給世界各地的兒童和我們的品牌,但未來還會有更多。

  • Now, moving on to a new program that Richard had mentioned, and that's in MSA, multiple system atrophy.

    現在,轉到理查德提到的一個新項目,那就是 MSA,多系統萎縮。

  • This is a devastating, fatal, and neurodegenerative adult disease.

    這是一種毀滅性的、致命的、神經退化性成人疾病。

  • It's characterized by autonomic failure, cerebellar ataxia, and Parkinsonism.

    其特徵是自主神經衰竭、小腦性共濟失調和巴金森氏症。

  • It's particularly devastating to think that in five years, 60% of these patients become wheel-bound, and by 12 years after diagnosis, few of the patients are still living.

    尤其令人震驚的是,5 年內,這些患者中 60% 的人開始依賴車輪出行,而診斷後 12 年後,幾乎沒有患者還活著。

  • It's an orphan disease of about 65,000 patients in the G7, and there's currently no available treatments for this terrible disease.

    這是一種罕見疾病,在七國集團中約有 65,000 名患者,目前還沒有針對這種可怕疾病的治療方法。

  • Our program, Emrusolmin, is an important program that targets the alpha-synuclein aggregates that drive the disease pathology.

    我們的計畫 Emrusolmin 是一個重要的項目,針對驅動疾病病理的 α-突觸核蛋白聚集體。

  • Now, it's important to remember, this is an orally administered small molecule.

    現在,重要的是要記住,這是一種口服小分子。

  • It's brain-penetrant.

    真是透腦子啊。

  • That means it gets to not only the membrane-bound alpha-synuclein aggregate, but also the intracellular forms.

    這意味著它不僅可以到達膜結合的 α-突觸核蛋白聚集體,還可以到達細胞內的形式。

  • And that's important because Emrusolmin has the potential to be a disease-modifying treatment.

    這很重要,因為 Emrusolmin 有潛力成為一種疾病緩解療法。

  • It blocks the early aggregates, destabilizes them, creates less toxic early aggregates, and drives them into monomeric form.

    它會阻止早期聚集體,破壞它們的穩定性,產生毒性較小的早期聚集體,並將它們驅動成單體形式。

  • It also blocks the formation of the larger aggregates as well.

    它也會阻止較大聚集體的形成。

  • So really important action, and we're very excited to be starting a Phase 2 study in the second half of this year.

    這是非常重要的行動,我們很高興能在今年下半年開始第二階段研究。

  • Now, moving on to another program that we're excited to show progress in, that's our anti-PD1-IL2 ATTENUKINE program.

    現在,我們很高興能展示另一個專案的進展,那就是我們的抗 PD1-IL2 ATTENUKINE 專案。

  • This is an exciting program because it brings together two important aspects of the immune system, targeted therapies to the PD1 T cells, but bringing an attenuated IL2 to those cells.

    這是一個令人興奮的計劃,因為它匯集了免疫系統的兩個重要方面,即針對 PD1 T 細胞的標靶治療,同時為這些細胞帶來減弱的 IL2。

  • So that's really bringing a powerful cytokine signal to the cells to fight tumor cancer -- tumor cells.

    所以這確實為細胞帶來了強大的細胞激素訊號來對抗腫瘤細胞——腫瘤細胞。

  • So this is an important thing.

    所以這是一件重要的事情。

  • The goal here is to not only activate these T cells, but avoid the cytotoxic toxicity of high doses of IL2.

    這裡的目標不僅是激活這些 T 細胞,而且是避免高劑量 IL2 的細胞毒性。

  • And you can see in this ex vivo study to the left that when you look at melanoma cells with human PBMCs, we have great activity for the anti-PD1-IL2, but also an additional activity if you combine it with a drug such as Keytruda.

    您可以在左側的離體研究中看到,當您用人類PBMC 觀察黑色素瘤細胞時,我們對抗PD1-IL2 具有很強的活性,而且如果將其與Keytruda 等藥物結合使用,還會產生額外的活性。

  • So we're very excited.

    所以我們非常興奮。

  • We've screened our first patient in the study and more to come in the future.

    我們已經篩選了研究中的第一位患者,未來也會篩選更多患者。

  • So as Richard mentioned, we're progressing our innovative pipeline both early and late.

    正如理查德所提到的,我們正在早期和晚期推進我們的創新管道。

  • Starting with Olanzapine LAI, I mentioned we accelerated by nine months.

    從奧氮平 LAI 開始,我提到我們加速了九個月。

  • We'll have the full safety database complete by the second half of this year.

    我們將在今年下半年完成完整的安全資料庫。

  • So we're on target.

    所以我們已經達到目標了。

  • Duvakitug is now moving forward.

    杜瓦基圖格現在正在向前邁進。

  • We accelerated by three months, and we're going to be looking for those top line results in the fourth quarter of 2024.

    我們加快了三個月的速度,我們將在 2024 年第四季看到這些頂線結果。

  • Our anti-IL15 program is now fully enrolled, a POC study for Celiac disease, and we've opened a new IND for vitiligo, and we'll be finishing up our Phase 1 work the second half of this year.

    我們的抗IL15計畫現已全部入組,針對乳糜瀉的POC研究,我們已經針對白斑症開啟了新的IND,我們將在今年下半年完成我們的一期工作。

  • Our anti-PD1, as I mentioned, anti-PD1-IL2, as I mentioned, has now screened its first patient.

    正如我所提到的,我們的抗 PD1 抗體、抗 PD1-IL2 抗體,正如我所提到的,現在已經篩檢了第一個患者。

  • We're looking for full enrollment by 2026 of part one.

    我們希望在 2026 年第一部分實現全面註冊。

  • And our dual action rescue inhaler, ICS/SABA, we're on target for patient recruitment.

    我們的雙作用救援吸入器 ICS/SABA,我們正瞄準病患招募目標。

  • We'll work to accelerate that program as well.

    我們也將努力加速該計劃。

  • We're on target for the second half of 2026.

    我們的目標是 2026 年下半年。

  • And finally, Emrusolmin.

    最後是埃姆魯索爾明。

  • I'm particularly proud to be getting a Phase 2 study started this year.

    我對今年開始的第二階段研究感到特別自豪。

  • And with that, I'll pass it off to Eli Kalif.

    接下來,我會將其轉交給 Eli Kalif。

  • Eliyahu Kalif - Chief Financial Officer, Executive Vice President

    Eliyahu Kalif - Chief Financial Officer, Executive Vice President

  • Thank you, Eric.

    謝謝你,埃里克。

  • And good morning.

    早安.

  • And good afternoon to everyone.

    大家下午好。

  • I will begin my review of our Q2 2024 financial results with slide 26, starting with our GAAP performance.

    我將從幻燈片 26 開始回顧 2024 年第二季的財務業績,首先是我們的 GAAP 表現。

  • Revenue in the second quarter of 2024 were $4.2 billion, an increase of 7% in US dollars or 11% in local currency terms compared to the second quarter of 2023.

    2024年第二季營收為42億美元,與2023年第二季相比,以美元計算成長7%,以當地貨幣計算成長11%。

  • This increase in revenue was mainly driven by growth from generic products across all our segments globally, including strong contribution from generics Revlimid and the launch of generic Victoza in the US and strong continued growth from AUSTEDO.

    營收的成長主要得益於我們全球所有細分市場的仿製藥產品的成長,包括仿製藥 Revlimid 的強勁貢獻和仿製藥 Victoza 在美國的推出以及 AUSTEDO 的強勁持續成長。

  • In Q2 2024, we recorded a GAAP operating loss of $5 million compared to an operating loss of $654 million in the same quarter last year.

    2024 年第二季度,我們的 GAAP 營運虧損為 500 萬美元,而去年同期的營運虧損為 6.54 億美元。

  • This improvement in the second quarter of 2024 was mainly driven by higher revenue and gross profit as well as legal settlement and loss contingencies and the goodwill impairment charges compared to the same quarter last year.

    與去年同期相比,2024 年第二季的改善主要是由於收入和毛利的增加以及法律和解和損失意外費用以及商譽減損費用的推動。

  • GAAP net loss in Q2 2024 was $846 million, and GAAP loss per share was $0.75 compared to the net loss of $872 million and a loss per share of $0.78 in Q2 of last year.

    2024 年第二季的 GAAP 淨虧損為 8.46 億美元,GAAP 每股虧損為 0.75 美元,而去年第二季的淨虧損為 8.72 億美元,每股虧損為 0.78 美元。

  • The lower net loss in the second quarter of 2024 was mainly due to the lower operating loss that I just discussed, partially offset by higher income taxes related to the settlement agreement we announced in June with the Israeli tax authorities to resolve all pending litigation for the company's taxable years from 2008 until 2020.

    2024 年第二季淨虧損較低,主要是由於我剛才討論的營業虧損較低,部分被我們6 月份與以色列稅務機關宣布的和解協議相關的較高所得稅所抵消,該和解協議旨在解決所有未決訴訟公司的課稅年度為2008年至2020年。

  • Turning to slide 27.

    轉到投影片 27。

  • You can see that total non-GAAP adjustment in the second quarter of 2024 were $1.5 billion, similar to Q2 2023.

    您可以看到,2024 年第二季的非 GAAP 調整總額為 15 億美元,與 2023 年第二季類似。

  • A notable non-GAAP adjustment this quarter includes corresponding tax effect and unusual tax items of $503 million, mainly related to the settlement agreement with the Israeli tax authorities I just mentioned.

    本季值得注意的非公認會計準則調整包括相應的稅務影響和5.03億美元的異常稅項,主要與我剛才提到的與以色列稅務機關的和解協議有關。

  • Other notable adjustments include a goodwill impairment charge of $400 million related to our TAPI reporting units based on Teva's Pivot to Growth strategy assumption and our planning for divestment.

    其他值得注意的調整包括根據 Teva 的「轉向成長」策略假設和我們的撤資計劃,與我們的 TAPI 報告單位相關的 4 億美元商譽減損費用。

  • Now, moving to slide 28 for a review of our non-GAAP performance.

    現在,轉到幻燈片 28,回顧我們的非 GAAP 業績。

  • As I mentioned earlier, our second quarter revenue were approximately $4.2 billion, an increase of 7% in US dollars or 11% in local currency terms compared to Q2 of last year.

    正如我之前提到的,我們第二季的營收約為 42 億美元,與去年第二季相比,以美元計算成長了 7%,以當地貨幣計算成長了 11%。

  • Our non-GAAP gross profit margin was 52.9% compared to 52.2% in Q2 2023 and 51.4% in the first quarter of '24.

    我們的非 GAAP 毛利率為 52.9%,而 2023 年第二季為 52.2%,2024 年第一季為 51.4%。

  • This increase in our non-GAAP gross profit margin, both compared to last year and the first quarter of 2024, was mainly driven by expected improvement in our portfolio mix, mainly from strong continued growth from AUSTEDO as well as the decrease in our operation costs.

    與去年和 2024 年第一季相比,我們的非公認會計準則毛利率的成長主要是由於我們的投資組合組合的預期改善,主要來自 AUSTEDO 的強勁持續成長以及我們營運成本的下降。

  • As we progress through the rest of the year, we expect our gross margin to continue to improve in the second half, driven by continuous improvement in our portfolio mix, with a strong continued growth in our innovative products and continuation of our cost optimization programs.

    隨著今年剩餘時間的進展,我們預計下半年的毛利率將繼續提高,這得益於我們的產品組合不斷改善、創新產品的強勁持續成長以及成本優化計畫的持續實施。

  • Moving to non-GAAP operating margin in Q2 2024, which was 25.3% compared to 26.1% in Q2 2023.

    2024 年第二季的非 GAAP 營業利潤率為 25.3%,而 2023 年第二季為 26.1%。

  • This decrease in GAAP operating margin in the second quarter of 2024 was mainly due to higher sales and marketing and R&D expenses as a percentage of revenue, reflecting our deliberate investments to support our key growth engines, including promotional activities related to AUSTEDO and investment in our late-stage pipeline assets, both in line with our Pivot to Growth strategy.

    2024 年第二季GAAP 營運利潤率的下降主要是由於銷售和行銷以及研發費用佔收入的百分比上升,反映出我們為支持我們的關鍵成長引擎而進行的刻意投資,包括與AUSTEDO 相關的促銷活動以及對我們的後期管道資產,均符合我們的成長策略。

  • These were partially offset by our higher gross margin.

    這些被我們較高的毛利率部分抵銷。

  • We ended the quarter with a non-GAAP earnings per share of $0.61 compared to $0.56 in Q2 2023, mainly driven by higher operating income and lower financial expenses.

    本季結束時,我們的非 GAAP 每股收益為 0.61 美元,而 2023 年第二季為 0.56 美元,這主要是由於營業收入增加和財務費用減少。

  • Now, moving to slide 29.

    現在,轉到投影片 29。

  • As communicated in the beginning of this year, we are making a thoughtful and deliberate investment to support our growing innovative portfolio as well as progress and accelerated our key pipeline assets.

    正如今年年初所傳達的那樣,我們正在進行深思熟慮的投資,以支持我們不斷增長的創新投資組合以及進展並加速我們的關鍵管道資產。

  • As you can see, this is reflected in our first half results, a continued improvement in our portfolio mix and a disciplined cost management in driving our margin expansion as well as enabling us to invest in our business to drive short-term and long-term growth.

    正如您所看到的,這反映在我們上半年的業績中,我們的投資組合不斷改善,嚴格的成本管理推動了我們的利潤率擴張,並使我們能夠投資於我們的業務以推動短期和長期的增長生長。

  • Looking at the rest of 2024, we expect to see operating leverage in the second half of this year, driven by expected ramp in our revenue and continue to expect operating expenses to be in the initially provided range of 27% to 27.5% for the full year.

    展望 2024 年剩餘時間,在營收預期成長的推動下,我們預計今年下半年的營運槓桿率將達到預期,並繼續預期營運費用將在最初提供的 27% 至 27.5% 的範圍內。

  • Turning to free cash flow on slide 30.

    轉向幻燈片 30 上的自由現金流。

  • Our free cash flow in the second quarter of 2024 was $324 million compared to $632 million in Q2 2023.

    我們 2024 年第二季的自由現金流為 3.24 億美元,而 2023 年第二季為 6.32 億美元。

  • The decrease in the free cash flow in the second quarter of 2024 resulted mainly from changes in working capital items due to revenue growth, including a negative impact from accounts receivable due to timing of collections and accounts payable, higher tax payments as well as higher proceeds from divestitures of business and other assets in the second quarter of last year.

    2024年第二季自由現金流的減少主要是由於收入成長導致營運資本項目發生變化,包括因收款和應付帳款時間安排而產生的應收帳款負面影響、更高的稅款以及更高的收益去年第二季剝離業務和其他資產。

  • Today, we are reaffirming our 2024 free cash flow guidance which we initially provided in January.

    今天,我們重申我們最初在 1 月提供的 2024 年自由現金流指引。

  • Our 2024 free cash flow is expected to be in the range of $1.7 billion to $2 billion, and we expected it to continue to pick up during the second half of the year, driven by higher revenue and profitability as well as working capital improvements.

    我們 2024 年的自由現金流預計在 17 億至 20 億美元之間,並且在收入和盈利能力提高以及營運資本改善的推動下,我們預計下半年自由現金流將繼續增加。

  • Turning to slide 31.

    轉到投影片 31。

  • Our net debt at the end of Q2 2024 was $16.4 billion.

    截至 2024 年第二季末,我們的淨負債為 164 億美元。

  • Our gross debt was $18.6 million compared to $19.8 million at the end of 2023.

    我們的總債務為 1,860 萬美元,而 2023 年底為 1,980 萬美元。

  • The decrease in our gross debt was mainly due to repayment of $956 million or 6% seniority notes at maturity in April 2024 and the positive impact of $247 million from exchange rate fluctuations.

    我們的總債務減少主要是由於償還了2024年4月到期的9.56億美元或6%的優先票據以及匯率波動帶來的2.47億美元的正面影響。

  • Our net debt to EBITDA slightly improved, coming in 3.3 times for Q2 2024, mainly due to higher EBITDA.

    我們的 EBITDA 淨債務略有改善,為 2024 年第二季的 3.3 倍,主要是 EBITDA 較高。

  • As of June 30 and as of today, there is no amount outstanding under our $1.8 billion revolving credit facilities.

    截至 6 月 30 日和今天,我們的 18 億美元循環信貸額度中沒有任何未償還金額。

  • Now, let's turn to slide 32 to our 2024 non-GAAP outlook discussion.

    現在,讓我們轉向幻燈片 32,討論 2024 年非 GAAP 展望。

  • As Richard highlighted earlier and as I reflected on the first half of this year, we have made a solid progress in terms of our revenue.

    正如理查德早些時候強調的那樣,以及我對今年上半年的反思,我們在收入方面取得了堅實的進展。

  • This includes solid momentum in our key growth engine, especially AUSTEDO, which continues to see strong demand, supported by our focus on investment.

    這包括我們關鍵成長引擎的強勁動力,尤其是 AUSTEDO,在我們對投資的關注的支持下,需求持續強勁。

  • In addition, our core generics business continued to perform very well across all our markets, and we also expected COPAXONE revenue to be better than initially guided in our provided guidance in January.

    此外,我們的核心仿製藥業務在所有市場上繼續表現良好,我們也預計 COPAXONE 收入將優於我們 1 月提供的指導中的最初指導。

  • Therefore, to reflect our revenue performance in the first half, along with expected development in the second half of 2024, we are raising our 2024 full year revenue guidance to $16 billion to $16.4 billion.

    因此,為了反映我們上半年的營收表現以及 2024 年下半年的預期發展,我們將 2024 年全年營收指引上調至 160 億至 164 億美元。

  • This reflects an increase of $200 million at the midpoint of our previous guidance range.

    這反映了我們之前指導範圍中點增加了 2 億美元。

  • Accordingly, we are also raising the lower end of our 2024 non-GAAP outlook for operating income and EBITDA by $100 million and lower end of the earnings per share guidance by $0.10 to be between $2.30 to $2.50.

    因此,我們也將 2024 年非 GAAP 營業收入和 EBITDA 展望下限調高 1 億美元,將每股盈餘指引下限提高 0.10 美元,至 2.30 美元至 2.50 美元之間。

  • We continue to expect our non-GAAP gross margin to be between 53% to 54% for the full year, with a gradual pickup in the margin in the second half of the year, in line with our revenue trajectory and portfolio mix as well as improvement from our ongoing cost optimization programs.

    我們仍然預計全年非 GAAP 毛利率將在 53% 至 54% 之間,下半年利潤率將逐步回升,這與我們的收入軌跡和投資組合以及我們正在進行的成本優化計劃的改進。

  • Like I mentioned earlier, we expect to see operating leverage in the second half of the year and our operating expenses to be as initially provided range of 27% to 27.5% for the full year.

    正如我之前提到的,我們預計下半年的營運槓桿率將達到最初設定的 27% 至 27.5%。

  • Coming to free cash flow, we continue to expect free cash flow to be between $1.7 billion to $2 billion for the full year.

    在自由現金流方面,我們仍然預期全年自由現金流在 17 億美元至 20 億美元之間。

  • With this, I conclude my review of Teva results for the second quarter of 2024.

    至此,我結束了對 Teva 2024 年第二季業績的回顧。

  • And now, I will hand it back to Richard for a summary.

    現在,我將把它交還給理查德,讓他做一個總結。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Thank you, Eli.

    謝謝你,伊萊。

  • And I'd just like to take the opportunity to reiterate our 2027 financial guidance.

    我想藉此機會重申我們的 2027 年財務指引。

  • We aim to grow at mid-single digit revenue, the operating margin at 30% we're committed to, net debt-to-EBITDA 2 times and cash flow to earnings of 80%.

    我們的目標是營收實現中個位數成長,營業利潤率達到我們承諾的 30%,淨負債與 EBITDA 的比率達到 2 倍,現金流與收益的比率達到 80%。

  • So once again, we reiterate our commitment to that.

    因此,我們再次重申對此的承諾。

  • Now, if I move on to our confidence in that and what drives that is the Pivot to Growth strategy.

    現在,如果我繼續談談我們對此的信心以及推動這一點的動力,那就是「以成長為中心」策略。

  • And as you know, the first period of time was '23 to '24 to return the company to growth.

    如您所知,第一個時期是 23 至 24 年,使公司恢復成長。

  • And as I showed on my earlier slide, we've done six quarters of growth.

    正如我在之前的幻燈片中所示,我們已經實現了六個季度的成長。

  • And we continue to believe we will be returning to growth and have the opportunity to continue on that journey because of the work we're doing and the results we're seeing with AUSTEDO, UZEDY, AJOVY and also the generics business as well as the biosimilar pipeline starting to come through.

    我們仍然相信,我們將恢復成長,並有機會繼續這一旅程,因為我們正在做的工作以及我們在 AUSTEDO、UZEDY、AJOVY 以及仿製藥業務以及生物仿製藥管道開始出現。

  • We believe that allows us to position ourselves to '25 and beyond to continue that growth and accelerate it based on some of the exciting programs that Eric has talked about, but also the fact that in those products I've mentioned, AUSTEDO and UZEDY, we have growth that we predicted and we've communicated as well that we think can drive beyond '25.

    我們相信,這使我們能夠將自己定位到 25 歲及以後,繼續這種增長,並基於 Eric 談到的一些令人興奮的計劃以及我提到的那些產品 AUSTEDO 和 UZEDY 的事實來加速它,我們的成長符合我們的預測,我們也進行了溝通,認為可以推動25 年後的發展。

  • So with that, we remain very optimistic about the future.

    因此,我們對未來仍然非常樂觀。

  • And I'd like to close the presentation.

    我想結束演示。

  • And now, open it up to questions and answers.

    現在,開放問題和答案。

  • Operator

    Operator

  • (Operator Instructions) Ash Verma, UBS.

    (操作員說明)Ash Verma,UBS。

  • Ash Verma - Analyst

    Ash Verma - Analyst

  • Great.

    偉大的。

  • Good morning.

    早安.

  • Thanks.

    謝謝。

  • Thanks for taking my question and I have two.

    感謝您提出我的問題,我有兩個問題。

  • So just on the API business, it's good to see back to growth dynamics here.

    因此,就 API 業務而言,很高興看到這裡的成長動態。

  • Can you talk broadly about like what's the composition of this business?

    您能大致談談這個業務的組成嗎?

  • Is it like small molecule, heavy, large molecule or peptide or any flexibility to switch the mix?

    它是小分子、重分子、大分子還是勝肽,還是可以靈活切換組合?

  • And it seems like the demand trends are very different depending on which segment you're in.

    而且,根據您所在的細分市場,需求趨勢似乎大不相同。

  • So that would have some significant implication on the divestment proceeds.

    因此,這將對撤資收益產生重大影響。

  • And then, secondly, on AUSTEDO, I wanted to ask like, do you expect to be on the CMS list for 2027?

    其次,關於 AUSTEDO,我想問一下,您預計會出現在 2027 年的 CMS 名單上嗎?

  • Thanks.

    謝謝。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Great.

    偉大的。

  • Thanks, Ash.

    謝謝,阿什。

  • Thanks for the questions.

    感謝您的提問。

  • Always appreciate it.

    永遠感激它。

  • So with regard to TAPI, I think what I can say is that the exciting thing about TAPI is it works across all technologies and platforms.

    因此,關於 TAPI,我認為我可以說的是,TAPI 令人興奮的一點是它適用於所有技術和平台。

  • So it's the second-largest API manufacturer in the world with extensive R&D and manufacturing capabilities.

    因此它是全球第二大原料藥生產商,擁有廣泛的研發和製造能力。

  • So we touch every aspect of API across all platforms and technologies, which has allowed us to return it to growth quickly because obviously we can work with many partners, CDMOs, as well as actually pharmaceutical companies.

    因此,我們跨所有平台和技術接觸 API 的各個方面,這使我們能夠快速恢復成長,因為顯然我們可以與許多合作夥伴、CDMO 以及實際上的製藥公司合作。

  • So we feel very confident that company is -- that part of our business is well positioned for growth for this year as well as beyond when it's separated.

    因此,我們對公司非常有信心——我們的部分業務在今年以及分離後都處於良好的成長勢頭。

  • With regard to AUSTEDO and your question about I think the IRA and the pending change in the payer landscape, what I would say, when we put the Pivot to Growth strategy together in last year and we communicated our $2.5 billion target for AUSTEDO in 2027, if you remember, we communicated that we took into account IRA at that point.

    關於 AUSTEDO 以及您關於 IRA 和付款人格局即將發生的變化的問題,我想說的是,當我們去年制定“以增長為中心”戰略並傳達了 2027 年 AUSTEDO 25 億美元的目標時,如果你還記得的話,我們表示當時我們考慮了IRA。

  • And so, we have included that within our forecast going forward.

    因此,我們已將其納入我們的未來預測中。

  • Now, it's a dynamic situation and as we get more information, obviously that gives us more clarity on what we've planned for and what we've -- the assumptions we've made.

    現在,這是一個動態的情況,隨著我們獲得更多信息,顯然這使我們更清楚我們的計劃和我們所做的假設。

  • So that answers that second part of the question.

    這回答了問題的第二部分。

  • I think I will add though, as you've seen by the presentation today, both from Eric and myself, we have a lot of assets as well coming through.

    我想我要補充一點,正如您在今天的演示中看到的那樣,無論是來自埃里克還是我自己,我們也有很多資產。

  • We have UZEDY, which is gaining momentum.

    我們有 UZEDY,它的勢頭正在增強。

  • We have Olanzapine that's coming to the market.

    我們的奧氮平即將上市。

  • We have ICS/SABA that's coming to an exciting market that's differentiated.

    我們的 ICS/SABA 即將進入一個令人興奮的差異化市場。

  • And then we have obviously in a slightly longer midterm, we have TL1A.

    然後我們顯然有一個稍長的中期,我們有 TL1A。

  • So I think -- I hope I've answered your question clearly on AUSTEDO, but I also would like to highlight to everybody that we have an innovative pipeline that is maturing very quickly, and that also helps us maintain our growth trajectory.

    所以我想——我希望我已經清楚地回答了你們關於 AUSTEDO 的問題,但我也想向大家強調,我們擁有一條正在迅速成熟的創新管道,這也有助於我們保持成長軌跡。

  • Thanks for your question, Ash.

    謝謝你的提問,阿什。

  • Operator

    Operator

  • Balaji Prasad, Barclays.

    巴拉吉·普拉薩德,巴克萊銀行。

  • Balaji Prasad - Analyst

    Balaji Prasad - Analyst

  • Hi.

    你好。

  • Good morning, everyone.

    大家早安。

  • And great to see the all-round growth across all business segments.

    很高興看到所有業務部門的全面成長。

  • Two questions from me, firstly on AUSTEDO.

    我提出兩個問題,首先是關於 AUSTEDO。

  • Richard, you have commented, and you have spoken about the efforts that you have been doing in revamping this business.

    理查德,您發表了評論,並談到了您在改革這項業務方面所做的努力。

  • Maybe it's a good time to kind of revisit and help us understand what's working here and where do you see scope for further improvement in the field with regard to diagnosis or spreading the knowledge?

    也許現在是重新審視並幫助我們了解這裡的工作原理的好時機,以及您認為該領域在診斷或傳播知識方面有哪些進一步改進的空間?

  • Two, on SIMLANDI, I think what we are seeing latest biosimilar MI trends is like 20% biosimilar MI have 20% in market share.

    第二,在 SIMLANDI 上,我認為我們看到的最新生物相似藥 MI 趨勢是 20% 的生物相似藥 MI 佔據 20% 的市場份額。

  • We are yet to see SIMLANDI starting to impact this and accelerate the trend.

    我們尚未看到 SIMLANDI 開始影響這一趨勢並加速這一趨勢。

  • So you did call out that you expect to see launch in Q3 and Q4, and your partner has commented upon purchase orders booked for 1.1 million units, approximately 10% of the market.

    因此,您確實表示預計將在第三季和第四季推出,而您的合作夥伴已對預訂的 110 萬台採購訂單發表評論,約佔市場的 10%。

  • So could you quantify what that means in terms of impact for Teva?

    那麼您能否量化這對 Teva 的影響意味著什麼?

  • Thanks.

    謝謝。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Thanks, Balaji.

    謝謝,巴拉吉。

  • Appreciate the questions.

    感謝您提出的問題。

  • So on AUSTEDO, what keeps driving the momentum and the performance, I think I've sort of mentioned this in the past, but it is worth reiterating.

    因此,在 AUSTEDO 上,是什麼推動了勢頭和性能,我想我過去已經提到過這一點,但值得重申。

  • We have a great team.

    我們有一支很棒的團隊。

  • We put together an absolutely great team, world-class team here.

    我們在這裡組建了一支絕對優秀的團隊,世界一流的團隊。

  • We've given that team the resources necessary to execute the plans that they have, and that execution is getting better quarter on quarter.

    我們已經為該團隊提供了執行他們所製定的計劃所需的資源,並且執行情況逐季變得更好。

  • Some of the plans this team put in place last year, we're only going to start to really gain traction this year.

    該團隊去年制定的一些計劃今年才會開始真正發揮作用。

  • And there are other things that have been done by this team that'll gain momentum.

    團隊還做了其他一些事情,這些事情將獲得動力。

  • DTC is one of them, bringing more of these undiagnosed patients into the office, but that's merely just one of them.

    DTC 就是其中之一,它將更多未確診的患者帶入辦公室,但這只是其中之一。

  • There's many things this team are doing around the channel, effectiveness, adherence, getting patients onto therapy, onto the right dose, but it really comes back to a world class team who know what they're doing.

    這個團隊圍繞著管道、有效性、依從性、讓患者接受治療、接受正確的劑量等方面做了很多事情,但這實際上取決於一個知道自己在做什麼的世界級團隊。

  • So that gives me a lot of confidence that this trajectory that AUSTEDO is on can be maintained.

    因此,這給了我很大的信心,相信 AUSTEDO 的這條軌跡能夠維持下去。

  • Now, with regard to SIMLANDI, we did launch in Q2, as you pointed out, and we have had significant interest from the channel and the payers.

    現在,關於 SIMLANDI,正如您所指出的,我們確實在第二季度推出了,並且頻道和付款人對我們產生了濃厚的興趣。

  • So what I've communicated in my presentation is we're well set.

    所以我在演講中傳達的訊息是我們已經準備就緒。

  • We have the channel stocked.

    我們有渠道庫存。

  • We've had good interaction and we're getting ever increasing coverage with the payers.

    我們已經進行了良好的互動,並且我們與付款人的覆蓋範圍不斷擴大。

  • And now it's down to us to try and pull that through, working with our partners to pull that through.

    現在,我們需要努力實現這一目標,並與我們的合作夥伴一起努力實現這一目標。

  • And I think that's when we're going to get more clarity on how effective we are at doing that, and the market is switching from the brand to the biosimilars in Q3 and Q4.

    我認為那時我們將更清楚地了解我們在這方面的效率,而市場正在第三季和第四季從品牌轉向生物相似藥。

  • So I'd say there's more to come on that as we play out the rest of the year, but we're excited by the opportunity.

    所以我想說,隨著今年剩下的時間,我們還會有更多的事情要做,但我們對這個機會感到興奮。

  • And as I keep communicating, we have a portfolio here and we're going to keep bringing this portfolio to the market.

    正如我不斷溝通的那樣,我們在這裡有一個產品組合,我們將繼續將該產品組合推向市場。

  • I think the US market's going to continue to mature and become more dynamic and more receptive to biosimilars.

    我認為美國市場將繼續成熟,變得更有活力,更容易接受生物相似藥。

  • We've seen that start this year.

    我們從今年就看到了這種情況。

  • I envision that will continue throughout the rest of this year and years going forward.

    我預計這種情況將在今年剩餘時間和未來幾年持續下去。

  • So we remain excited about how biosimilars and our portfolio can help drive Pivot to Growth.

    因此,我們對生物相似藥和我們的產品組合如何幫助推動成長保持興奮。

  • Thanks, Balaji.

    謝謝,巴拉吉。

  • Operator

    Operator

  • David Amsellem, Piper Sandler.

    大衛·阿姆塞勒姆,派珀·桑德勒。

  • David Amsellem - Analyst

    David Amsellem - Analyst

  • Hey, thanks.

    嘿,謝謝。

  • So I wanted to drill down more on operating leverage, not so much for the back half of this year, but longer term.

    因此,我想更深入地了解營運槓桿,不是今年下半年的情況,而是更長期的情況。

  • So in terms of spend, you've got eventual launch of LAI Olanzapine, so there's launch spend there, obviously investments in AUSTEDO.

    因此,就支出而言,最終會推出 LAI 奧氮平,因此那裡有啟動支出,顯然是對 AUSTEDO 的投資。

  • And then of course, you're talking about further investment in R&D.

    當然,你正在談論進一步的研發投資。

  • So can you just talk about the trajectory of spend longer term and how that fits in with your ability to drive significant operating leverage as we move through next year and longer term.

    那麼,您能否談談長期支出的軌跡,以及在我們進入明年和更長期的過程中,這與您推動顯著營運槓桿的能力有何關係。

  • So that's number one.

    所以這是第一。

  • And then secondly, can talk more broadly about your neuroscience business and specifically how M&A fits into that.

    其次,可以更廣泛地談論您的神經科學業務,特別是併購如何融入其中。

  • You have a leverageable asset with your sales organization.

    您的銷售組織擁有可利用的資產。

  • So how much of that is a priority as opposed to just focusing on cultivating the pipeline?

    那麼,與僅僅專注於培養管道相比,其中有多少是優先事項呢?

  • So help us understand your thought process there.

    所以請幫助我們理解您的思考過程。

  • Thank you.

    謝謝。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Thanks, David.

    謝謝,大衛。

  • Thanks for the question.

    謝謝你的提問。

  • So on operating leverage, a couple of things to help sort of frame it.

    因此,在營運槓桿方面,有幾件事可以幫助建造它。

  • Firstly, we have a lot of opportunity at Teva to drive growth.

    首先,我們在 Teva 有很多機會來推動成長。

  • And I think as I've communicated in the past, we've made a decision to invest in that, to make sure we can take this opportunity and maximize it.

    我認為正如我過去所傳達的那樣,我們已經決定對此進行投資,以確保我們能夠抓住這個機會並最大限度地利用它。

  • And that's both across the products we have in the market, AUSTEDO, UZEDY, AJOVY, and soon to be Olanzapine, as well as the pipeline that Eric's team are bringing through quickly.

    這不僅包括我們在市場上擁有的產品,AUSTEDO、UZEDY、AJOVY,以及即將推出的奧氮平,也包括 Eric 團隊正在快速推出的產品線。

  • Now, just a couple of things to build on what you said.

    現在,根據您所說的內容,我們需要做幾件事。

  • Obviously, when it comes to launching Olanzapine, we already have the infrastructure, the sales force, everything in place with UZEDY.

    顯然,在推出奧氮平時,我們已經有了 UZEDY 的基礎設施、銷售團隊以及一切準備就緒。

  • So that's a beautiful synergy we have there.

    所以這是我們之間美妙的協同作用。

  • So as we launch some of these products, we see probably maybe an incremental increase in S&M, but nothing of any major because we have this C&S-focused sales force that we can leverage.

    因此,當我們推出其中一些產品時,我們可能會看到 S&M 的增量成長,但沒有任何重大變化,因為我們擁有可以利用的以 C&S 為中心的銷售團隊。

  • So I think that's one thing to understand.

    所以我認為這是需要理解的一件事。

  • The other thing is, we have thought very carefully about how we accelerate our pipeline and how in some cases we've partnered with people to do that because we're conscious that we do want to achieve leverage.

    另一件事是,我們非常仔細地考慮瞭如何加速我們的管道,以及在某些情況下我們如何與人們合作來做到這一點,因為我們意識到我們確實希望獲得影響力。

  • We do want to get to the 30%, and we believe we've developed a path to do that.

    我們確實希望達到 30%,我們相信我們已經找到了實現這一目標的途徑。

  • The other thing I'd add in, which I did have on one of my slides, but I didn't talk about is, we're also increasing the performance in the efficiency within our manufacturing base, which obviously is a significant cost base.

    我要補充的另一件事是,我在一張投影片上確實提到了這一點,但我沒有談論的是,我們還在提高製造基地的效率,這顯然是一個重要的成本基礎。

  • And so, we put together a value-added program, we call it values acceleration program, sorry, which is all about driving down COGS, driving in efficiency, driving improvement in net working capital in all the fundamentals, but we're going after that with a real vigor.

    因此,我們制定了一個增值計劃,我們稱之為價值加速計劃,抱歉,這一切都是為了降低銷售成本,提高效率,推動所有基本面淨營運資本的改善,但我們正在追求充滿活力。

  • So that's also going to be able to improve our gross margin, which will help obviously fall down the P&L.

    因此,這也將能夠提高我們的毛利率,這將有助於顯著降低損益表。

  • And obviously, to highlight, we've hired Matt Shields, our new head of manufacturing, TGO, who comes with a great wealth of experience of putting programs like that in place.

    顯然,需要強調的是,我們聘請了 TGO 的新任製造主管 Matt Shields,他在實施此類計劃方面擁有豐富的經驗。

  • So that's another area.

    這是另一個領域。

  • So that's why we believe we remain confident about hitting the 30% margin.

    這就是為什麼我們相信我們仍然有信心達到 30% 的利潤率。

  • And also, I'd like to add on that, we do have significant growth in these products, in AUSTEDO, in UZEDY, and Olanzapine and ICS/SABA.

    另外,我想補充一點,我們在 AUSTEDO、UZEDY、奧氮平和 ICS/SABA 等產品方面確實取得了顯著成長。

  • And I think that's where also people need to understand how that with the different gross margin falls down the P&L.

    我認為這也是人們需要了解不同毛利率如何影響損益表的地方。

  • Now, to move on to your second question about our neuroscience business, we're very excited about it.

    現在,轉到關於我們神經科學業務的第二個問題,我們對此感到非常興奮。

  • We're very excited about the capability, and I think we've had a few questions around this, about how we've managed to really drive the performance of AUSTEDO, also the performance of AJOVY in a very competitive market, and the acceleration and the momentum we've got behind UZEDY.

    我們對此功能感到非常興奮,我認為我們對此有一些疑問,關於我們如何真正推動 AUSTEDO 的性能,以及 AJOVY 在競爭非常激烈的市場中的性能,以及加速以及我們在 UZEDY 背後的動力。

  • So that is an asset, and I think you described it as that, our sales organization, our commercial team, and we are looking to add to that.

    所以這是一項資產,我認為您將其描述為我們的銷售組織、我們的商業團隊,我們正在尋求補充。

  • So let me be very clear, we are, but we are pretty choosy.

    所以讓我非常明確地說,我們是,但我們非常挑剔。

  • We're very mindful of Teva's position, Teva's balance sheet, and the opportunity we have organically.

    我們非常關注 Teva 的地位、Teva 的資產負債表以及我們有機擁有的機會。

  • So we want to make sure whatever asset we bring in, it is complementary from a financial perspective, as well as complementary from a capability perspective.

    因此,我們希望確保我們引進的任何資產,從財務角度來看都是互補的,從能力角度來看也是互補的。

  • And so, we are looking, but we want to make sure we do the right decision because we think we have good momentum.

    因此,我們正在尋找,但我們希望確保做出正確的決定,因為我們認為我們有良好的動力。

  • We're the right track.

    我們走在正確的道路上。

  • And So we want to make sure that it's additive to that.

    所以我們想確保它是附加的。

  • So that's the answer to your second question, David.

    這就是你第二個問題的答案,大衛。

  • And appreciate your questions.

    感謝您的提問。

  • Operator

    Operator

  • Jason Gerberry, Bank of America.

    傑森‧格伯里,美國銀行。

  • Jason Gerberry - Analyst

    Jason Gerberry - Analyst

  • Hey, guys.

    嘿,夥計們。

  • Thank you for taking my questions.

    感謝您回答我的問題。

  • First one is just on generic Revlimid.

    第一個是通用來那度胺(Revlimid)。

  • It's clearly a big contributor from what I can gather.

    從我收集到的信息來看,這顯然是一個很大的貢獻者。

  • And so how should investors think about the sort of size of this product?

    那麼投資人該如何看待該產品的規模呢?

  • They're going to need to model, this is revenue that will need to be replaced in 2026 when the limited competition dynamics come to an end.

    他們需要建模,當有限的競爭動態結束時,這將需要在 2026 年取代。

  • And along those lines, I'm seeing like in the first half, non-GAAP adjustments of about $270 million for contingent considerations on future royalties tied to generic Revlimid.

    沿著這些思路,我看到上半年,非公認會計準則調整約為 2.7 億美元,用於與仿製藥 Revlimid 相關的未來特許權使用費的或有考慮。

  • So can you talk to the accounting on that?

    那你能和會計談談這個問題嗎?

  • Is that just sort of a planned future royalties over the next 1.5 years while the product is subject to limited competition?

    這是否只是未來 1.5 年計畫的未來特許權使用費,而該產品的競爭有限?

  • So those are my questions.

    這就是我的問題。

  • Thanks.

    謝謝。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Okay, Jason.

    好吧,傑森。

  • Thanks for the questions.

    感謝您的提問。

  • I'll start and maybe give Eli a chance to also contribute so you don't have to just continuously listen to me talk.

    我會開始,也許給伊萊一個機會也做出貢獻,這樣你就不必一直聽我說話。

  • So we're pleased about -- firstly, let me just say we're pleased about our generics business, 14% growth globally.

    因此,我們很高興——首先,我只想說,我們對我們的仿製藥業務全球成長 14% 感到高興。

  • And we have a big business, as I've mentioned many times in the past, in Europe and international, and that's growing at 8% and 22%.

    正如我過去多次提到的,我們在歐洲和國際上擁有龐大的業務,並且正在以 8% 和 22% 的速度成長。

  • So really proud of that and congratulations to the team, and I want to make sure we appreciate that.

    對此我感到非常自豪,並向團隊表示祝賀,我想確保我們對此表示讚賞。

  • Now, moving on to the US, which obviously we saw significant growth.

    現在,轉向美國,顯然我們看到了顯著的成長。

  • Now, part of that is driven by Revlimid, the continued good performance there, but I do want to remind everybody that we have launched a number of complex generics into the market this year, and that also drives growth, as well as we launched Victoza in Q2.

    現在,部分原因是來那度胺(Revlimid)的持續良好表現,但我確實想提醒大家,我們今年已經向市場推出了許多複雜的仿製藥,這也推動了增長,我們還推出了 Victoza在第二季。

  • And obviously, Victoza's an exciting opportunity, the first GLP-1 into the market.

    顯然,Victoza 是一個令人興奮的機會,是第一個進入市場的 GLP-1。

  • And so, that's received a lot of attention.

    因此,這受到了很多關注。

  • And so, also that's helping us drive growth.

    因此,這也有助於我們推動成長。

  • We also do have just underlying good performance in our generics business as we manage our supply chain better than we've done in the past.

    我們的仿製藥業務也確實取得了良好的業績,因為我們比過去更好地管理了我們的供應鏈。

  • So I think all those fundamentals fit together.

    所以我認為所有這些基本原則都是相互契合的。

  • Now, we are aware that in Revlimid, there is going to come a point where this does come to an end, and because of that, we're focusing really hard on making sure we bring our high-value complex directs to the market on time more often.

    現在,我們意識到來那度胺(Revlimid)的這種情況將會結束,正因為如此,我們非常努力地專注於確保我們將高價值的複合直接藥物推向市場時間更頻繁。

  • And I think you've seen some progress on that, and we have more than to come hopefully this year as well as early next year.

    我認為你們已經看到了這方面的一些進展,而且我們希望今年和明年初能取得更多進展。

  • We also have our biosimilar portfolio, which I've highlighted earlier, is six biosimilars to come to the market.

    我們還有我們的生物相似藥產品組合,我之前強調過,有六種生物相似藥即將上市。

  • So as we put those together with the improvement in the operational efficiency of our base generics business, I think we have the ability to minimize the impact of Revlimid when that product has more competition.

    因此,當我們將這些與基礎仿製藥業務營運效率的提高結合起來時,我認為當該產品面臨更多競爭時,我們有能力將 Revlimid 的影響降至最低。

  • So that's the way we view it and we are planning for it.

    這就是我們的看法和計劃。

  • So I think we feel that we're in a good place.

    所以我認為我們感覺我們處於一個很好的位置。

  • We have to keep executing, of course.

    當然,我們必須繼續執行。

  • But with that, I'll hand it over to Eli to answer more of that specific question around the royalties.

    但接下來,我將把它交給 Eli 來回答更多有關版稅的具體問題。

  • Eliyahu Kalif - Chief Financial Officer, Executive Vice President

    Eliyahu Kalif - Chief Financial Officer, Executive Vice President

  • Yes.

    是的。

  • So Jason, as you saw last quarter and this quarter, actually year-to-date, we're around $238 million on the adjustment on the continuous consideration.

    Jason,正如您在上個季度和本季看到的那樣,實際上今年迄今為止,我們對持續考慮的調整約為 2.38 億美元。

  • This quarter is $174 million.

    本季為 1.74 億美元。

  • This is coming strictly from the fact that based on accounting rules, you need to forecast actually -- that's the ability that you have on the balance sheet, which is coming from legacy acquisitions, as you know.

    這嚴格來自於這樣一個事實:根據會計規則,你需要實際進行預測——這就是你在資產負債表上擁有的能力,正如你所知,它來自於遺留收購。

  • And this is just a reflection of our forecast.

    這只是我們預測的反映。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Thanks, Jason.

    謝謝,傑森。

  • Thanks for the questions.

    感謝您的提問。

  • Operator

    Operator

  • Omri Efroni, Oppenheimer.

    奧姆裡·埃夫羅尼,奧本海默。

  • Omri Efroni - Analyst

    Omri Efroni - Analyst

  • Hi, guys.

    嗨,大家好。

  • And congrats on a great quarter.

    並祝賀這個季度的出色表現。

  • I was wondering if you have -- if can give some of color about the biosimilars market share in the United States, because last time we talked, the market wasn't open yet because (inaudible) paid the PBMs rebates, and I was wondering if some movement has been taken into the market.

    我想知道您是否可以對美國生物仿製藥市場份額提供一些信息,因為上次我們談話時,市場尚未開放,因為(聽不清楚)支付了 PBM 回扣,我想知道如果市場出現一些變動。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Hi, Omri.

    嗨,奧姆裡。

  • Good morning.

    早安.

  • I didn't quite catch that question clearly.

    我不太清楚這個問題。

  • Maybe if you could repeat it, that'd be helpful.

    如果你能重複一遍,也許會有幫助。

  • Thank you.

    謝謝。

  • Omri Efroni - Analyst

    Omri Efroni - Analyst

  • I was wondering if Teva has seen some movement in the biosimilar market in the United States because last time we talked, the biosimilar market was pretty close, and I was wondering if the dynamics has changed.

    我想知道 Teva 是否看到了美國生物相似藥市場的一些變化,因為上次我們談話時,生物相似藥市場非常接近,我想知道這種動態是否發生了變化。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Yes.

    是的。

  • Okay, I got it.

    好的,我明白了。

  • Thank you for that.

    謝謝你。

  • Thank you for repeating.

    謝謝您重複一遍。

  • So the dynamics have changed, and it continues to remain dynamic.

    因此,動態已經改變,並且將繼續保持動態。

  • So we have seen more of an appetite for the PBMs and the payers to embrace the opportunity of biosimilars.

    因此,我們看到 PBM 和付款人越來越有興趣擁抱生物相似藥的機會。

  • That said, it is a complex market in the US and how you take that and how you drive that through the channel to the physician, to the patient is variable.

    也就是說,美國是一個複雜的市場,你如何看待這個市場以及如何透過管道將其傳遞給醫生和患者是可變的。

  • But I think what is most important for me is, as we've seen it with some of the deals that we've done on private label and other things, that the payers and the PBMs and the channel are really looking at biosimilars in a different way.

    但我認為對我來說最重要的是,正如我們在自有品牌和其他方面所做的一些交易中看到的那樣,付款人、PBM 和管道確實在考慮生物仿製藥不同的方式。

  • And I think they're seen this as a strategic opportunity to help them manage costs better and help them give access to these important therapies to patients.

    我認為他們將此視為一個策略機會,可以幫助他們更好地管理成本並幫助他們為患者提供這些重要的治療方法。

  • But it's dynamic, and I use that word specifically because it is constantly changing.

    但它是動態的,我專門使用這個詞是因為它不斷變化。

  • And so, I don't think this is necessarily a straight line.

    所以,我認為這不一定是一條直線。

  • I think we'll end up at a place where it becomes very settled, but I think we're still on that journey.

    我認為我們最終會到達一個非常穩定的地方,但我認為我們仍在這段旅程中。

  • Omri Efroni - Analyst

    Omri Efroni - Analyst

  • Okay.

    好的。

  • Got it.

    知道了。

  • And maybe a follow-up question.

    也許還有一個後續問題。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Yes.

    是的。

  • Go ahead.

    前進。

  • Operator

    Operator

  • Umer Raffat, Evercore.

    烏默·拉法特,Evercore。

  • Umer Raffat - Analyst

    Umer Raffat - Analyst

  • Hi, guys.

    嗨,大家好。

  • Thanks for taking my question.

    感謝您提出我的問題。

  • I have a couple here if I may.

    如果可以的話,我這裡有一對。

  • Perhaps first, Richard, I know you spoke to the AUSTEDO dynamic, but could you remind us, is it about half of it, which is Medicare?

    也許首先,理查德,我知道您談到了 AUSTEDO 動態,但您能否提醒我們,其中大約一半是醫療保險?

  • Because I was trying to think about potential IRA inclusion in 2027, and if half the sales have a 25% price cut, wouldn't it mean AUSTEDO could be flat in 2027?

    因為我試圖考慮 2027 年可能納入 IRA,如果一半的銷售額降價 25%,那不是意味著 2027 年 AUSTEDO 可能會持平嗎?

  • So I'm just trying to think about the $2.5 billion number, and maybe that's broadly the ballpark, not precisely to the dot, but just wanted to put that in perspective.

    所以我只是想考慮一下 25 億美元的數字,也許這只是大概的數字,並不精確,但只是想客觀地看待這個數字。

  • Secondly, on TL1A, could you confirm there was not any interim analysis?

    其次,關於TL1A,你能確認沒有進行任何中期分析嗎?

  • Thank you very much.

    非常感謝。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Hi, Umer.

    嗨,烏默。

  • Thanks for the question.

    謝謝你的提問。

  • So I'll answer the first part and then I'll let Eric answer the other one, just so Eric can talk.

    所以我會回答第一部分,然後讓艾瑞克回答另一部分,這樣艾瑞克就可以說話了。

  • I don't want him to go through the hour without talking.

    我不想讓他一個小時都不說話。

  • So answering the question on AUSTEDO, look, I think as I said in my first comments, we have taken into account the IRA with AUSTEDO.

    因此,在回答有關 AUSTEDO 的問題時,我認為正如我在第一條評論中所說,我們已經將 IRA 與 AUSTEDO 納入考慮。

  • And we thought about that long and hard last year because we only set the $2.5 billion.

    去年我們認真思考了這個問題,因為我們只設定了 25 億美元。

  • We knew that would be challenged for many reasons.

    我們知道這會因多種原因而受到挑戰。

  • And so, we wanted to be sure.

    因此,我們想確定一下。

  • Now, so we have taken into account.

    現在,我們已經考慮到了。

  • Now, one of the things you've highlighted is we don't know how this is going to play out accurately.

    現在,您強調的一件事是我們不知道這將如何準確地發揮作用。

  • And we're going to learn a lot in the next few weeks, and we're going to learn a lot in the next six months.

    我們將在接下來的幾週內學到很多東西,並且在接下來的六個月內我們將學到很多東西。

  • And that allows us to refine the assumptions we made and those predictions we made.

    這使我們能夠完善我們所做的假設和我們所做的預測。

  • But I feel confident because of the fact that we took it into account right at the start, and I think that was the most important thing.

    但我很有信心,因為我們從一開始就考慮到了這一點,我認為這是最重要的事情。

  • So as that becomes even clearer, more accurate, we'll come back to you, Umer, and everybody else to give you an update on that.

    因此,當這變得更加清晰、更加準確時,我們將向您、Umer 和其他所有人提供最新情況。

  • But I feel we're in a good position.

    但我覺得我們處於有利位置。

  • With regard to the TL1A, I'll hand that to Eric.

    關於 TL1A,我會把它交給 Eric。

  • So over to you, Eric.

    那就交給你了,艾瑞克。

  • Eric Hughes - Executive Vice President - Global R & D, Chief Medical Officer

    Eric Hughes - Executive Vice President - Global R & D, Chief Medical Officer

  • And thank you, Umer, for the question.

    謝謝烏默爾提出的問題。

  • And I can confirm, there's been no interim analysis for our TL1A program.

    我可以確認,我們的 TL1A 計畫沒有進行中期分析。

  • The study remains blinded.

    該研究仍然是盲目的。

  • We're just very excited that we're able to accelerate the enrollment, get the full data set going so that we can bring that into 2024 in the fourth quarter.

    我們非常高興能夠加快註冊速度,獲得完整的資料集,以便我們可以在 2024 年第四季實現這一目標。

  • This is agreed upon by our DMC, and we're excited just to accelerate the program so we have a full data set by the end of the year.

    這是我們的 DMC 同意的,我們很高興能夠加速該計劃,以便我們在今年年底之前擁有完整的數據集。

  • Operator

    Operator

  • Glen Santangelo, Jefferies.

    格倫桑坦傑洛,傑弗里斯。

  • Glen Santangelo - Analyst

    Glen Santangelo - Analyst

  • Yes.

    是的。

  • Thanks for taking my questions.

    感謝您回答我的問題。

  • I just wanted -- two quick ones for me.

    我只是想要——給我兩個快速的。

  • First, I wanted to follow up on the strength of the generics business.

    首先,我想跟進仿製藥業務的實力。

  • I mean, Richard, you obviously called out the contribution from Revlimid, epinephrine, and Truxima.

    我的意思是,理查德,您顯然指出了 Revlimid、腎上腺素和 Truxima 的貢獻。

  • I think you also mentioned Victoza in the press release, but that seems like it was launched right before the end of the quarter.

    我想您在新聞稿中也提到了 Victoza,但它似乎是在本季度末之前推出的。

  • And so, I'm just trying to think about the growth outlook in the second half of the year in the generics business relative to the first just sort of given the unique characteristics of the Revlimid agreement, offset potentially by the recent launch of Victoza and maybe what's going on with SIMLANDI, et cetera.

    因此,考慮到 Revlimid 協議的獨特特徵(可能被最近推出的 Victoza 和 Victoza 所抵消),我只是想考慮一下仿製藥業務相對於上半年的增長前景。

  • So if you could just sort of frame the second half for us versus the first half.

    所以,如果你能為我們安排下半場與上半場的比較。

  • And then, my second question maybe is for Eli.

    然後,我的第二個問題可能是問伊萊的。

  • I'm just kind of curious if you can give us a rough sense of the profitability characteristics of the TAPI business so we can maybe start to get some working assumptions about the potential proceeds from this divestment in 2025.

    我只是有點好奇您能否讓我們大致了解 TAPI 業務的盈利特徵,以便我們可以開始對 2025 年此次撤資的潛在收益做出一些可行的假設。

  • Thanks.

    謝謝。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Thanks for the question, Glen.

    謝謝你的提問,格倫。

  • So I'll start with the first one on generics and then hand over to Eli.

    所以我將從第一個仿製藥開始,然後交給 Eli。

  • So I think you've highlighted a number of the variables which have made the performance of our generics business in the US strong and perform well.

    因此,我認為您強調了一些使我們在美國的仿製藥業務表現強勁且表現良好的變數。

  • And I think as Eli has highlighted, that is part of why we're raising our guidance for the year, is our generics business is performing well across the globe as well.

    我認為,正如 Eli 所強調的那樣,這就是我們提高今年指引的部分原因,因為我們的仿製藥業務在全球範圍內也表現良好。

  • So I think we remain confident that the strategy we're executing around our generics business is paying out well.

    因此,我認為我們仍然相信,我們圍繞仿製藥業務執行的策略取得了良好的回報。

  • I would also like to highlight, and I think it's well understood that when it comes to Revlimid, the majority of sales occur in Q2 and Q3.

    我還想強調的是,我認為眾所周知,來那度胺 (Revlimid) 的大部分銷售發生在第二季和第三季。

  • And so, obviously you see the slowdown there from a Revlimid contribution in Q4.

    因此,顯然您會看到第四季度來那度胺 (Revlimid) 貢獻的放緩。

  • But at the same time, we've got Victoza that we've launched and we've seen a good start to that.

    但同時,我們已經推出了 Victoza,我們已經看到了一個好的開始。

  • And we have some other complex generics that we're going to be launching in Q3 and Q4.

    我們還有一些其他複雜的仿製藥,我們將在第三季和第四季推出。

  • So our aim, going back to the strategy, is always to keep focusing on our pipeline and bring it to the market as fast as possible.

    因此,回到策略上,我們的目標始終是繼續專注於我們的產品線並儘快將其推向市場。

  • But to answer your question, yes, the guidance has been moved because of some of our innovative products, but also our generics business.

    但要回答你的問題,是的,由於我們的一些創新產品以及我們的仿製藥業務,指南已被移動。

  • Over to you, Eli.

    交給你了,伊萊。

  • Eliyahu Kalif - Chief Financial Officer, Executive Vice President

    Eliyahu Kalif - Chief Financial Officer, Executive Vice President

  • Yes.

    是的。

  • So we are in a very mature process, I will say with the API.

    所以我們正處於一個非常成熟的流程中,我會說 API。

  • We will come with more, better updates in the next quarter.

    我們將在下個季度提供更多、更好的更新。

  • We're not providing actually any prediction about the proceeds because we want to respect the process with the potential buyers and our advisors that are helping us in these transactions.

    我們實際上並沒有提供任何有關收益的預測,因為我們希望尊重潛在買家和在這些交易中幫助我們的顧問的流程。

  • And so, we just need to be a bit patient.

    所以,我們只需要有點耐心。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Thanks for the questions, Glen.

    謝謝你的提問,格倫。

  • Operator

    Operator

  • Chris Schott, JPMorgan.

    克里斯‧肖特,摩根大通。

  • Chris Schott - Analyst

    Chris Schott - Analyst

  • Great.

    偉大的。

  • Thanks so much for the questions.

    非常感謝您的提問。

  • First question was just on the biosimilar Stelara market.

    第一個問題是關於生物相似藥 Stelara 市場。

  • Assuming, given the launch next year, you're starting to have some payer discussions, I'm just wondering if you see any similarities or relevant differences we should think about relative to how biosimilar Humira shaped up.

    假設明年推出,您將開始進行一些付款人討論,我只是想知道您是否看到我們應該考慮的與生物仿製藥 Humira 的形成方式有任何相似之處或相關差異。

  • My second question was on the Olanzapine LAI opportunity.

    我的第二個問題是關於奧氮平 LAI 機會。

  • Can you just elaborate a little bit more about how you're thinking about the market development?

    能否詳細說明一下您對市場發展的看法?

  • And specifically, do you think of this as largely a conversion of oral Olanzapine, or is it an opportunity to convert existing LAI products?

    具體來說,您認為這在很大程度上是口服奧氮平的轉換,還是轉換現有 LAI 產品的機會?

  • And maybe a second part to that Olanzapine question.

    也許是奧氮平問題的第二部分。

  • There does seem to be a lot of enthusiasm for the muscarinics that are going to be launching in 2025 and 2026.

    人們似乎對 2025 年和 2026 年推出的毒蕈鹼藥物有著極大的熱情。

  • Does that factor at all in terms of how you think about an uptake for Olanzapine LAI, if physicians are kind of excited to try a new mechanism in their tougher patients, could that be a hurdle at all to getting penetration with Olanzapine LAI?

    就您如何看待奧氮平 LAI 的吸收而言,這個因素是否重要? 如果醫生很興奮在病情較重的患者中嘗試一種新機制,那麼這是否會成為奧氮平 LAI 滲透的障礙?

  • Thanks so much.

    非常感謝。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Thanks, Chris.

    謝謝,克里斯。

  • Appreciate the questions.

    感謝您提出的問題。

  • So starting with the biosimilar of Stelara, I think a couple of things that I think play out here is, one, from our perspective -- I'll talk them from our perspective and from the markets.

    因此,從 Stelara 的生物相似藥開始,我認為這裡發生的一些事情是,第一,從我們的角度來看——我將從我們的角度和市場的角度來談論它們。

  • From our perspective, we know we're going to be able to launch in February 2025.

    從我們的角度來看,我們知道我們將能夠在 2025 年 2 月推出。

  • We've had approval from the FDA.

    我們已經獲得 FDA 的批准。

  • And so, that allows us to plan effectively.

    因此,這使我們能夠有效地進行計劃。

  • We probably didn't have that luxury in the past with biosimilar Humira because of the challenges we faced, as you know.

    如您所知,由於我們面臨的挑戰,我們過去可能沒有那麼奢侈地使用生物相似藥 Humira。

  • Now, we can't start talking to payers until six months prior to February because that's part of the agreement.

    現在,我們要到二月之前的六個月才能開始與付款人交談,因為這是協議的一部分。

  • But there's many things that we have learned through biosimilar Humira, as well as the time we'll have for the team to plan for that.

    但我們透過生物相似藥 Humira 學到了很多東西,也讓我們的團隊有時間為此進行規劃。

  • So I think that sets us up better.

    所以我認為這讓我們的處境變得更好。

  • With regard to the market, how is that going to play out?

    就市場而言,這將如何發揮作用?

  • What I've learned from my time launching lots of biosimilars, particularly in Europe as well is, no one biosimilar is the same.

    我從推出大量生物相似藥(尤其是在歐洲)的過程中學到的是,沒有一種生物相似藥是相同的。

  • That said, I would say the people, the PBMs, the payers, the channel, are becoming more knowledgeable and have an increasing appetite for the benefit of biosimilars, and that will play favorably for Stelara.

    也就是說,我想說的是,人們、PBM、付款人、通路正在變得更加了解,並且對生物相似藥的好處越來越感興趣,這將對 Stelara 有利。

  • So I think the market's changing, becoming more receptive.

    所以我認為市場正在發生變化,變得更容易接受。

  • We are getting more experience in how to bring these products to the market in this dynamic market.

    我們在如何在這個充滿活力的市場中將這些產品推向市場方面獲得了更多經驗。

  • So I think that gives us a positive encouragement for how we can launch Stelara.

    所以我認為這給我們推出 Stelara 帶來了積極的鼓勵。

  • Now, moving on to the Olanzapine opportunity, you are right.

    現在,轉向奧氮平機會,您是對的。

  • There is a lot of excitement around this.

    圍繞這一點有很多令人興奮的事情。

  • And the reason why there's a lot of excitement is Olanzapine is the number one prescribed molecule for treating schizophrenia.

    之所以如此令人興奮,是因為奧氮平是第一個治療精神分裂症的處方分子。

  • And it's the number one because it's considered the most efficacious.

    它是第一名,因為它被認為是最有效的。

  • But there isn't a long-acting that meets the needs of the physicians.

    但目前還沒有一種長效藥物能滿足醫師的需求。

  • And so hence the excitement.

    因此,人們感到興奮。

  • Now, you ask where it's going to come from.

    現在,你問它從哪裡來。

  • Is it going to come from oral Olanzapine or are we going to start switching some of the other long-actings?

    它是來自口服奧氮平還是我們要開始更換其他一些長效藥物?

  • I think our going in assumption is it's going to come from the orals because obviously a patient that's on Olanzapine oral, they haven't been able to go into a long-acting because they don't have that availability, and we see that as a simple opportunity.

    我認為我們的假設是它將來自口服藥物,因為顯然服用奧氮平口服藥物的患者,他們無法進入長效治療,因為他們沒有這種可用性,我們認為一個簡單的機會。

  • Will there be some of the long-actings that could come across if they need more efficacy?

    如果需要更高的功效,是否會出現一些長效藥物?

  • I think that's probably -- the answer to that is yes.

    我認為這可能是——答案是肯定的。

  • How much?

    多少?

  • We'll see.

    我們拭目以待。

  • And we are building more and more of an understanding as we've got these positive results through, and we're going to the market to understand how physicians think about this.

    隨著我們獲得這些積極的結果,我們正在建立越來越多的理解,我們將前往市場了解醫生如何看待這個問題。

  • But that's my initial answer to that question.

    但這是我對這個問題的初步回答。

  • And then, with regard to some of the new mechanisms of action coming through, I'll start and then I'll hand over to Eric.

    然後,關於一些新的行動機制,我將開始,然後交給艾瑞克。

  • But one of the things we've seen and as we gain knowledge with launching UZEDY in this mark, I think we're getting really good knowledge of this physician community and the patients, as well as some of the research we're doing on Olanzapine is, these molecules are trusted and understood.

    但我們看到的一件事是,當我們透過在這個領域推出 UZEDY 來獲得知識時,我認為我們對這個醫生群體和患者以及我們正在進行的一些研究有了非常深入的了解奧氮平是,這些分子是值得信賴和理解的。

  • They do what they're required to do, and Olanzapine particularly is considered to be incredibly efficacious in helping patients control their schizophrenia.

    他們按照要求做的事情,特別是奧氮平被認為在幫助患者控制精神分裂症方面非常有效。

  • So I think in these conditions, understanding what works and what they have experience, plays out significantly, but I'll hand that over to somebody who's probably more educated on it, to Eric, to further answer it.

    所以我認為在這種情況下,了解什麼是有效的以及他們有什麼經驗會發揮重要作用,但我會將其交給可能受過更多教育的人,即埃里克,以進一步回答這個問題。

  • Eric Hughes - Executive Vice President - Global R & D, Chief Medical Officer

    Eric Hughes - Executive Vice President - Global R & D, Chief Medical Officer

  • Yes.

    是的。

  • Thank you, Richard.

    謝謝你,理查。

  • And it's exciting to see developments in the schizophrenia space.

    看到精神分裂症領域的發展令人興奮。

  • It's always good for patients, but to emphasize some things that Richard said, the value in UZEDY and Olanzapine LAI, is the long-acting injectable.

    這對患者總是有好處的,但要強調 Richard 所說的一些事情,UZEDY 和 Olanzapine LAI 的價值在於長效注射。

  • And the fact that they're well-known, tried and true medications that physicians use.

    事實上,它們是醫生使用的眾所周知、經過驗證的真實藥物。

  • So that change won't happen overnight.

    所以這種改變不會在一夜之間發生。

  • I think the value that we're launching and the science of where treatment of schizophrenia is going is in these convenient, easily used, convenient injectables that are easy for the patient to take.

    我認為我們正在推出的價值以及精神分裂症治療的科學進展在於這些方便、易於使用、方便患者服用的注射。

  • So that's the value and I think that that will stay for quite a while.

    這就是價值,我認為這種價值會持續很長一段時間。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Thanks, Eric and Chris.

    謝謝,埃里克和克里斯。

  • Thanks for the question.

    謝謝你的提問。

  • Operator

    Operator

  • Yifeng Liu, HSBC.

    劉亦鋒,匯豐銀行。

  • Yifeng Liu - Analyst

    Yifeng Liu - Analyst

  • Thank you for taking my question.

    感謝您回答我的問題。

  • I've got two.

    我有兩個。

  • The first one is on your sort of early-stage innovative assets.

    第一個是關於您的早期創新資產。

  • Just wonder how you're thinking about these assets and is the collaboration with Sanofi on TL1A something to refer to in the future?

    只是想知道您如何看待這些資產以及與賽諾菲在 TL1A 上的合作是否值得將來參考?

  • Or you are also thinking about doing the whole development in-house?

    或者您也在考慮在內部進行整個開發?

  • And my second question is on the guidance.

    我的第二個問題是關於指導。

  • So in the event of the TL1A possible Phase 3 happening, so is there any sort of milestone baked in this current guidance update?

    那麼,如果 TL1A 可能發生第 3 階段,那麼目前的指導更新中是否存在任何里程碑?

  • Thank you.

    謝謝。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • Okay.

    好的。

  • Thanks for the question.

    謝謝你的提問。

  • So we are very excited about our innovative pipeline, and as Eric's outlined, I think just to clarify something, the TL1A is in partnership with Sanofi.

    因此,我們對我們的創新管道感到非常興奮,正如 Eric 所概述的那樣,我想澄清一下,TL1A 是與賽諾菲合作的。

  • So the development of that into Phase 3 will be -- the Phase 3 execution will be done by our partner Sanofi, which we're very excited about because of their experience.

    因此,第三階段的開發將由我們的合作夥伴賽諾菲完成,我們對他們的經驗感到非常興奮。

  • With regards to the guidance, there are no milestones in this guidance for this year because we'll actually be moving into Phase 3 next year.

    關於指南,今年的指南沒有里程碑,因為我們實際上將在明年進入第三階段。

  • And as per our agreement that we announced, any milestone will occur once we enter Phase 3.

    根據我們宣布的協議,一旦進入第三階段,任何里程碑都會發生。

  • So if that does happen, that will be happening in 2025.

    因此,如果這種情況確實發生,那也將在 2025 年發生。

  • But thanks for your questions.

    但謝謝你的提問。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • At this time, we currently have no further questions.

    目前,我們沒有進一步的問題。

  • So I'll hand back to Richard for any further remarks.

    因此,我將把任何進一步的評論交還給理查德。

  • Richard Francis - President, Chief Executive Officer

    Richard Francis - President, Chief Executive Officer

  • So I'd just like to thank everybody for dialing in and having the interest in Teva.

    因此,我要感謝大家撥打電話並對 Teva 感興趣。

  • We very much appreciate that.

    我們非常讚賞這一點。

  • And thank you for your time.

    感謝您抽出時間。

  • And look forward to giving you an update on the performance of Teva and Pivot to Growth in Q3.

    並期待為您提供有關 Teva 和 Pivot to Growth 第三季業績的最新資訊。

  • Thank you.

    謝謝。

  • Bye-bye.

    再見。

  • Operator

    Operator

  • Thank you all for joining today's call.

    感謝大家參加今天的電話會議。

  • You may now disconnect your lines.

    現在您可以斷開線路。