Teva Pharmaceutical Industries Ltd (TEVA) 2024 Q1 法說會逐字稿

Hello, and welcome to the First Quarter 2024 Teva Pharmaceutical Industries Limited Earnings Conference Call. My name is Alex. I'll be coordinating the call today.

您好，歡迎參加 Teva Pharmaceutical Industries Limited 2024 年第一季財報電話會議。我的名字叫亞歷克斯。我今天將協調通話。

(Operator Instructions)

（操作員說明）

I'll now hand it over to your host, Ran Meir, Head of Investor Relations. Please go ahead.

現在我將把它交給東道主投資者關係主管蘭·梅爾 (Ran Meir)。請繼續。

Thank you, Alex, and thank you, everyone, for joining us today. We hope you have had a chance to review our Q1 results press release, along with the press release announcing positive Phase III results from olanzapine LAI trial, both issued earlier this morning. Copies of these press releases, along with the slides presented during this call are available on our website at ir.tevapharm.com.

謝謝你，亞歷克斯，也謝謝大家今天加入我們。我們希望您有機會閱讀我們的第一季結果新聞稿，以及宣布奧氮平 LAI 試驗第三階段積極結果的新聞稿，這兩份新聞稿均於今天早上發布。這些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. Additional information on these statements and our non-GAAP financial measures can be found on our earnings release, annual SEC Forms, 10-K and 10-Q.

請查看我們在投影片 #2 上的前瞻性陳述。有關這些報表和我們的非 GAAP 財務指標的更多信息，請參閱我們的收益發布、年度 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 first quarter results and business performance, recent events and our focus and priorities going forward. Then Dr. Eric Hughes, our Head of R&D and Chief Medical Officer, will discuss progress on our Innovative pipeline. Our CFO, Eli Kalif, will follow up by reviewing the first quarter financial results in more detail. Please note that today's call will run approximately 1 hour.

在今天的電話會議中，Teva 執行長 Richard Francis 將概述 Teva 第一季業績和業務表現、最近發生的事件以及我們未來的重點和優先事項。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。我們的財務長 Eli Kalif 隨後將更詳細地審查第一季的財務表現。請注意，今天的通話將持續約 1 小時。

And with that, I will now turn the call over to Richard. Richard, if you would, please.

現在，我將把電話轉給理查德。理查德，如果你願意的話，請。

Thank you, Ran, and good morning, everybody. Glad you could join us this morning. Excited to talk to you about our results for Q1 2024. Just to remind you, this is a year today almost since we launched the Pivot to Growth strategy, strategy designed to get Teva back to growth. And I'm pleased to say that this is our fourth quarter in a row of continuous growth. So the strategy is clearly having some effect, and I'll go into a bit of detail as to why that is and what's driving it.

謝謝你，蘭，大家早安。很高興你今天早上能加入我們。很高興與您談論我們 2024 年第一季的業績。我很高興地說，這是我們連續第四個季度持續成長。因此，該策略顯然產生了一些效果，我將詳細介紹原因以及驅動因素。

But just to remind you a bit about the strategy, it's based on 4 pillars: step up innovation -- deliver on our growth engine, step up innovation, create a sustainable generics powerhouse and focus our business. I'll walk you through what we've achieved on each of these areas. But obviously, we are starting to show that we can really commercialize innovative products.

但只是想提醒您該策略，它基於四大支柱：加強創新——提供我們的成長引擎，加強創新，創建可持續的仿製藥強國並專注於我們的業務。我將向您介紹我們在每個領域所取得的成就。但顯然，我們開始證明我們確實可以將創新產品商業化。

We are starting to show that we can take products through the clinic. And I think we'll talk a bit about olanzapine and the fact that we brought that to the clinic -- through the clinic, 9 months ahead of schedule. And we're showing good growth in our generics business and then I'll finalize with a talk about TAPI and how we've got that back to growth.

我們開始證明我們可以透過診所使用產品。我想我們會談談奧氮平以及我們將其帶到診所的事實——透過診所，比計劃提前 9 個月。我們的仿製藥業務顯示出良好的成長勢頭，最後我將討論 TAPI 以及我們如何使其恢復成長。

But before I do that, I wanted to start with some exciting news on olanzapine long-acting treatment for schizophrenia, which is in the clinic. We had the data readout on the efficacy of this study and it met its primary and secondary endpoints on all dose groups versus placebo. So we're very excited about this. And all doses were generally well tolerated, say, and there were no cases of PDSS. Obviously, the full submission of the safety database will be available in the second half of this year, but this is a really important milestone for ourselves as well as the patients who suffer from this terrible condition.

但在此之前，我想先介紹一些關於奧氮平長效治療精神分裂症的令人興奮的消息，該藥物已在臨床中使用。我們讀出了這項研究功效的數據，與安慰劑相比，它在所有劑量組上都達到了主要和次要終點。所以我們對此感到非常興奮。所有劑量的耐受性一般都很好，且沒有 PDSS 病例。顯然，完整的安全資料庫將於今年下半年提交，但這對我們自己以及患有這種可怕疾病的患者來說是一個非常重要的里程碑。

Now just to reiterate why we are excited about it. I move on to the next slide and just to sort of coordinate on the left-hand side of this slide, you'll see all molecules that are used to treat schizophrenia. And as you can see, the largest of these is olanzapine, which treats moderate to severe. But also, you can see on the right-hand side of this slide, there is no effective long-acting treatment of olanzapine. So there's a significant unmet medical need. And that's why we're so excited about this product and bringing this to the patients who clearly will benefit from it. So more news on that from Eric later in the presentation.

現在只是重申為什麼我們對此感到興奮。我轉到下一張投影片，只是為了在這張投影片的左側進行協調，您將看到用於治療精神分裂症的所有分子。正如您所看到的，其中最大的是奧氮平，可治療中度至重度。而且，您也可以在這張投影片的右側看到，奧氮平沒有有效的長效治療方法。因此，存在大量未滿足的醫療需求。這就是為什麼我們對這款產品如此興奮，並將其帶給顯然會從中受益的患者。埃里克稍後將在演講中介紹更多相關消息。

Now to dive into the results. So the results in constant currency, we were up 5% in revenue, up 12% in adjusted EBITDA, 18% in non-GAAP EPS and our net debt now stands at 3.38. So a good start to the year because of that, we are reconfirming our 2024 financial outlook.

現在深入研究結果。因此，以固定匯率計算的結果是，我們的收入增長了 5%，調整後的 EBITDA 增長了 12%，非 GAAP 每股收益增長了 18%，我們的淨債務目前為 3.38。因此，這是今年的良好開端，我們正在重申 2024 年的財務前景。

So let's go into a bit more detail on all of these numbers. So when it comes to driving this revenue, what I'm pleased to say is the fact that we're hitting it in all our business sectors. So whether it's Innovative or if it's the medicines, whether it's generics or whether it's TAPI and API, we're seeing good growth. And as you can see it, AUSTEDO with 67% growth is a really good start to the year, 18% on AJOVY and our Global Generics business has grown at a really healthy 9% and TAPI API is back to growth at 2%.

讓我們更詳細地了解所有這些數字。因此，當談到推動這項收入時，我很高興地說，我們在所有業務領域都在實現這一目標。因此，無論是創新藥還是藥品，無論是仿製藥還是 TAPI 和 API，我們都看到了良好的成長。正如您所看到的，AUSTEDO 成長了67%，這是今年的一個好開端，AJOVY 成長了18%，我們的全球仿製藥業務成長了9%，非常健康，TAPI API 也恢復了2% 的成長。

So let me go into a bit more detail on all of these. So starting with AUSTEDO. AUSTEDO continues to perform really well, $282 million for quarter 1, up 67% versus quarter 1 2023. And a good, strong TRx growth of 28%. And because of this momentum, we are confirming our guidance of $1.5 billion for 2024. But this momentum gives me more confidence and more excitement around our long-term goal, which is to get to $2.5 billion of revenue by 2027.

讓我更詳細地介紹所有這些內容。所以從 AUSTEDO 開始。 AUSTEDO 的表現持續非常出色，第一季營收為 2.82 億美元，比 2023 年第一季成長 67%。由於這種勢頭，我們確認了 2024 年 15 億美元的目標。

And I just wanted to use this slide to remind you everybody of the potential we have around this product unfortunately, because so many patients are yet to get on treatment. And that is why we started our direct-to-consumer campaign at the start of this year to make those people aware that there is an opportunity to help address this difficult condition and they just need to seek help with their physician. So a very encouraging start to the year with AUSTEDO, and we look forward to that momentum continuing.

不幸的是，我只是想用這張投影片提醒大家我們圍繞該產品的潛力，因為許多患者尚未接受治療。這就是為什麼我們在今年年初開始了直接面向消費者的活動，讓這些人意識到有機會幫助解決這個難題，他們只需要向醫生尋求幫助。 AUSTEDO 為今年帶來了非常令人鼓舞的開端，我們期待這種勢頭繼續下去。

Now moving on to the second part of our Innovative portfolio, which is AJOVY. Once again, good continued growth of 18%, and we're growing particularly strongly in Europe and international markets. But what pleases me about this product is we continue to show market share gains both in the U.S., Europe and international markets, showing the competitiveness of Teva sales and marketing when we have a product like this. So very pleased with that. And once again, I'm reconfirming the guidance of $0.5 billion for 2024.

現在轉向我們創新產品組合的第二部分，即 AJOVY。再次實現 18% 的良好持續成長，我們在歐洲和國際市場的成長尤其強勁。但這款產品令我高興的是，我們在美國、歐洲和國際市場上的市場份額不斷增加，顯示了梯瓦在擁有此類產品時的銷售和行銷競爭力。對此非常滿意。我再次重申 2024 年 5 億美元的指引。

Now moving on to UZEDY, the newest member of our Innovative family. So we launched this product last year, and the momentum continues to build. We continue to see good access when it comes to a fee-for-service in Medicaid. We're working with Medicare. The hospital has continued to expand their coverage, and we're seeing good order -- reordering from our hospitals. And this is driven by, once again, this very favorable product profile. We recently had the associate of psychiatrist meeting in the U.S. last week, I believe it was and the feedback continues to be really strong, particularly about disability to therapeutic doses within 24 hours without any oral supplement. So good momentum. And once again, I can confirm that the guidance of $80 million, we will be confident to achieving.

現在轉向 UZEDY，我們創新家族的最新成員。所以我們去年推出了這個產品，而且勢頭還在繼續增強。在醫療補助服務收費方面，我們仍然看到良好的准入條件。我們正在與 Medicare 合作。醫院繼續擴大覆蓋範圍，我們看到秩序良好——醫院重新訂購。這再次是由這種非常有利的產品概況所推動的。上週我們在美國召開了精神科醫生助理會議，我相信會議確實如此，而且反饋仍然非常強烈，特別是關於在沒有任何口服補充劑的情況下無法在 24 小時內達到治療劑量的問題。勢頭這麼好。我可以再次確認，我們將有信心實現 8000 萬美元的指導。

Now moving on to a slide which gives me a lot of pleasure to talk about, which is our Generics business. Just to sort of orientate you, remember, 65% of our business is outside the U.S., and we continue to see continued good growth in Europe of 5% and international markets of 16%. But I have to say, particularly pleased about the U.S. and the growth of 8% there. Now I think this highlights once again the Pivot to Growth strategy and the focus we placed on our Generics business to make sure we can bring products to the market more regularly on time, and we have a good supply chain that is good cost of goods. I think this is the start. We've got work to do, but this is very encouraging. I'm very pleased, and I want to congratulate the team on this.

現在轉到一張幻燈片，這讓我很高興談論我們的仿製藥業務。只是為了讓您了解一下，請記住，我們 65% 的業務位於美國以外，並且我們繼續看到歐洲 5% 和國際市場 16% 的持續良好成長。但我必須說，我對美國的成長特別滿意，那裡有 8% 的成長。現在我認為這再次凸顯了「以成長為中心」的策略以及我們對仿製藥業務的關注，以確保我們能夠更定期、更準時地將產品推向市場，並且我們擁有良好的供應鏈，具有良好的商品成本。我想這就是開始。我們還有工作要做，但這非常令人鼓舞。我很高興，我想就此向團隊表示祝賀。

Now moving on to another part of our business, which we're excited about, and that's our Biosimilar business. We're excited to be in a position in quarter 2 to be launching our biosimilar Humira and SIMLANDI and we're getting good interest from the payers, the PBMs and the channel with regard to this. Also pleased with the fact that our biosimilar Stelara is also approved and we'll be launching that in February of 2025. But it is worth pointing out that we have a portfolio of biosimilars, and we'll be launching 6 by 2027. So this is really an opportunity to support the Pivot to Growth strategy from a biosimilars perspective.

現在轉向我們業務的另一部分，我們對此感到興奮，那就是我們的生物相似藥業務。我們很高興能夠在第二季度推出我們的生物相似藥 Humira 和 SIMLANDI，付款人、PBM 和管道對此表現出了濃厚的興趣。我們也很高興我們的生物相似藥 Stelara 也獲得批准，我們將在 2025 年 2 月推出該產品。這確實是一個從生物相似藥角度支持成長策略的機會。

Now moving on to step up innovation. I won't go into some great details because Eric will, but on olanzapine, I've already touched upon. But the one thing I would like to highlight on this slide is the capability build and the execution ability that we have at Teva. Olanzapine was recruited 9 months ahead of schedule. TL1A is recruiting incredibly well in UC and CD and we've got ICS/SABA off to a good start, and that is now supported by the partnership we have with Launch Therapeutics and Abingworth. So we understand these assets are important to the patients who need them, and we're focusing on them and we're showing that focus can deliver performance.

現在持續加強創新。我不會詳細介紹一些重要的細節，因為艾瑞克會的，但關於奧氮平，我已經談到了。但我想在這張投影片上強調的一件事是我們在 Teva 的能力建立和執行能力。奧氮平的招募比原計劃提前了 9 個月。 TL1A 在 UC 和 CD 領域的招募情況非常好，我們已經為 ICS/SABA 開了一個良好的開端，現在我們與 Launch Therapeutics 和 Abingworth 的合作夥伴關係為這一點提供了支持。因此，我們知道這些資產對於需要它們的患者來說很重要，我們正在關注它們，我們表明，專注可以帶來績效。

But I want to take it a little minute now to talk to you a bit about our capabilities in CNS because obviously, I do talk a lot about AUSTEDO and AJOVY and rightly so. And olanzapine will get a lot of attention today, but we are building out a very good pipeline when it comes to CNS and we'll be giving you more and more information on this as we move forward. But once again, building a real foundation to Teva in CNS.

但我現在想花一點時間與大家談談我們在 CNS 方面的能力，因為顯然，我確實談論了很多關於 AUSTEDO 和 AJOVY 的內容，這是正確的。奧氮平今天將受到很多關注，但我們正在建立一個非常好的中樞神經系統產品線，隨著我們的進展，我們將向您提供越來越多的信息。但再次為 Teva 在 CNS 領域奠定了真正的基礎。

Now moving on to our final pillar, which is focused the business around TAPI that we obviously announced at the start of this year that we would be divesting TAPI, our API business. And I'm really pleased to see that the team with this freedom to operate outside of Teva and in the global $85 billion API market, they've really started to deliver and got off to a good start with a 2% growth.

現在轉向我們的最後一個支柱，即圍繞 TAPI 的業務，我們在今年年初明確宣布，我們將剝離我們的 API 業務 TAPI。我真的很高興看到團隊能夠在 Teva 之外以及價值 850 億美元的全球 API 市場中自由運營，他們確實開始交付成果，並取得了良好的開端，實現了 2% 的成長。

I see this momentum growing and this performance increasing because of the interest we've got from CDMOs and the interest is based on the fact that we have a broad technology base and our credibility of quality and supply reliability is clearly something that they're interested in. So good news and more to come, I think, on TAPI throughout the year.

我看到這種勢頭不斷增長，這種業績不斷提高，因為我們從CDMO 那裡得到了興趣，這種興趣是基於我們擁有廣泛的技術基礎，而且我們的品質可信度和供應可靠性顯然是他們有興趣的。

To close on something that is important to us, which is about how we operate as a company and how we contribute to society. We launched our sustainability goals in 2023. I just wanted to give you an update on how we progressed. So with regard to healthy people, we launched 7 programs to increase access to medicine across the globe. Healthy planet, we have reduced our carbon emissions by 27% versus 2019. And when it comes to how we conduct ourselves in our business being ethical and compliance, 100% of people who completed their training, and that was achieved in 2023.

結束對我們來說很重要的事情，即我們作為一家公司如何運作以及我們如何為社會做出貢獻。我們在 2023 年啟動了永續發展目標。因此，對於健康人群，我們啟動了 7 個項目，以增加全球範圍內獲得藥物的機會。為了健康的地球，我們的碳排放量比 2019 年減少了 27%。

Now with that, I'll conclude my session, and I'd like to hand over to Eric, who is Head of R&D. Over to you, Eric.

現在，我將結束我的會議，我想將會議交給研發主管 Eric。交給你了，艾瑞克。

Thank you, Richard. As Richard mentioned, we're very excited that today we announced the positive primary endpoint readout of our olanzapine LAI program. It also met its secondary end points -- key secondary endpoints. I thought I'd start off today by describing and reminding you of the study design and where we are in executing the study today.

謝謝你，理查。正如 Richard 所提到的，我們非常高興今天宣布了奧氮平 LAI 計畫的積極主要終點讀數。它也滿足了其次要終點——關鍵次要終點。我想我今天應該先描述並提醒大家研究設計以及我們今天執行研究的進展。

Remember, the study had an 8-week period. It's a randomized placebo-controlled study with 3 dose arms. And today, we are talking about the primary readout at the end of that 8 week. This study also includes a 48-week follow-up for safety that is now being executed with our full randomized patient size of about 675 subject, slightly over-enrolled. So it's important to note that, that second half of the study will be read out for the safety in the second half of this year.

請記住，該研究為期 8 週。這是一項具有 3 個劑量組的隨機安慰劑對照研究。今天，我們討論的是第 8 週結束時的主要讀數。這項研究還包括為期 48 週的安全性隨訪，目前正在對約 675 名受試者進行完全隨機化的患者規模執行，略有超額入組。因此值得注意的是，研究的後半部將在今年下半年宣讀安全性。

So when it comes to the primary efficacy end points, we are very excited to see that we met clinical significance and statistical significance on our primary endpoint using the PANSS score, you can see if the score was between 9.7 and 11.3 points in change from the baseline score. That's the change from baseline to week 8. So right where we expected the efficacy to be and clearly efficacious on all 3 dose groups. Importantly, we are also out to about 80% of our total target injections at this point, and we've seen no PDSS.

因此，當涉及主要療效終點時，我們非常高興地看到我們使用PANSS 評分在主要終點上達到了臨床顯著性和統計顯著性，您可以看到評分是否在9.7 到11.3 分之間變化。這是從基線到第 8 週的變化。重要的是，此時我們也完成了目標注射總量的 80% 左右，並且沒有看到 PDSS。

So the injections were well tolerated throughout the study. I should mention that the key secondary endpoints include the clinical global impressions for schizophrenia scale and the personal and social performance scale which both for all doses achieved clinical significance.

因此，在整個研究過程中註射的耐受性良好。我應該提到，關鍵的次要終點包括精神分裂症量表的臨床總體印像以及個人和社會表現量表，這兩個量表對於所有劑量都達到了臨床意義。

I would like to also say that this study illustrates our ability to execute and accelerate our programs in the Innovative space. We brought this study out up by 9 months. So a real good job by the clinical team.

我還想說，這項研究說明了我們在創新領域執行和加速專案的能力。我們將這項研究提前了 9 個月。所以臨床團隊做得非常好。

Moving on to AUSTEDO. We continue to do great work, informing our patients and our investigators about TD. We are running a study, a real-world observational study called IMPACT-TD. And this is something we're very proud of, where it's looking at both the patient voice and the caregiver perspective on what the impact of tardive dyskinesia is. This study is the largest study for tardive dyskinesia ever and it includes a wide range of ages, race and ethnicity, severities in their baseline movements and their treatment experience that's being run in 23 states in the United States.

繼續前往 AUSTEDO。我們將繼續進行出色的工作，向我們的患者和研究人員通報 TD。我們正在進行一項研究，一項名為 IMPACT-TD 的現實世界觀察研究。這是我們非常自豪的事情，它同時關注患者的聲音和照護者對遲發性運動障礙影響的看法。這項研究是有史以來規模最大的遲發性運動障礙研究，涵蓋了廣泛的年齡、種族和民族、基線運動的嚴重程度以及正在美國 23 個州進行的治療經驗。

And as I mentioned, we're developing a scale that really is measuring both what the patients tell us and what the caregivers see when it comes to tardive dyskinesia. So understanding tardive dyskinesia is our goal and educating our patients and caregivers is our mission. The first set of data will be announced or presented at the second Elevate meeting later this month.

正如我所提到的，我們正在開發一種量表，可以真正測量患者告訴我們的情況以及護理人員在遲發性運動障礙方面所看到的情況。因此，了解遲發性運動障礙是我們的目標，教育我們的患者和照護者是我們的使命。第一組數據將在本月稍後的第二次 Elevate 會議上公佈或呈現。

Now moving on to Asthma. Asthma is a significant patient population. It's a very important chronic illness in the U.S. and around the world, and the majority of these patients use rescue inhalers. There still is over 10 million Asthma exacerbations every year. And we've learned now that combination rescue inhalers are what's needed. And in fact, the guidelines provided the GINA guidelines have changed to the point where that's the recommendation for asthma exacerbations, that's the combination of both a beta agonist and a steroid.

現在轉向氣喘。哮喘是重要的患者群。在美國和世界各地，這是一種非常重要的慢性疾病，大多數患者都使用救援吸入器。每年仍有超過 1000 萬例氣喘發作。我們現在了解到需要組合救援吸入器。事實上，GINA 指南提供的指南已經發生了變化，其中建議氣喘加重，即 β 受體激動劑和類固醇的組合。

And that's why we're excited about our program, TEV-248. This is a combination rescue inhaler using albuterol and fluticasone, 2 well-known medications by our treating physicians. And the important thing is that this is a differentiated device. It's a dry powder inhaler, and that's important for when it comes to taking care of pediatric patients, that's what we're targeting in this study. We're excited that we started our Phase III study at this point. Enrollment is going well. But it's great to collaborate.

這就是為什麼我們對我們的 TEV-248 專案感到興奮。這是一種組合救援吸入器，使用沙丁胺醇和氟替卡松，這是我們的主治醫生使用的兩種眾所周知的藥物。重要的是，這是一款差異化的設備。它是一種乾粉吸入器，對於照顧兒科患者非常重要，這就是我們本研究的目標。我們很高興此時開始了第三階段研究。報名進展順利。但合作真是太好了。

Launch Therapeutics will help to accelerate the program even further and importantly, get those patients in the pediatric population going in the study. So very exciting to be delivering in the future a new treatment for asthmatic exacerbations in accordance with the GINA guidelines.

Launch Therapeutics 將有助於進一步加速該項目，更重要的是，讓兒科患者參與研究。非常令人興奮的是，未來能夠根據 GINA 指南提供一種治療氣喘急性發作的新療法。

Moving on to my last topic, the Anti-IL15 program. This is a very important program because our first indication we'll be taking this compound into is Celiac disease. Now IL15 is a key cytokine in the pathology of Celiac disease. When these patients eat gluten, it causes an inflammatory reaction that releases IL15 and activates intraepithelial lymphocytes. It's a large patient burden in the world and in the U.S., about 2 million patients, only about half of those patients are diagnosed. But the important thing to remember that 50% of these patients still have symptoms even while taking a gluten-free diet, 20% of these patients never even respond to gluten-free diet and 50% of these patients still want treatment beyond a gluten-free diet.

繼續我的最後一個主題，抗 IL15 計劃。這是一個非常重要的計劃，因為我們將這種化合物用於治療的第一個跡像是乳糜瀉。現在，IL15 是乳糜瀉病理學中的關鍵細胞因子。當這些患者食用麩質時，會引起發炎反應，釋放 IL15 並活化上皮內淋巴細胞。這對全世界和美國來說都是一個巨大的患者負擔，大約有 200 萬名患者，其中只有大約一半得到診斷。但要記住的重要一點是，即使採取無麩質飲食，這些患者中的50% 仍然有症狀，其中20% 的患者甚至對無麩質飲食沒有反應，其中50% 的患者仍然希望接受麩質以外的治療。

So that's why I'm excited about our Anti-IL15 program. I've shown you before that we have a very potent antibody that rapidly reduces free IL15 levels and keep those levels suppressed out to almost 80 days. We're exploring the compounded celiac patients right now. We're enrolling a patient by study by the end of this year.

這就是為什麼我對我們的抗 IL15 計劃感到興奮。我之前已經向您展示過，我們有一個非常有效的抗體，可以快速降低遊離 IL15 水平，並將這些水平抑製到近 80 天。我們現在正在探索複合性乳糜瀉患者。我們將在今年年底前透過研究招募一名患者。

Looking at a Celiac challenge study where we give a single dose of TEV-408 and then 2 weeks later, start a gluten-free diet for 14 weeks. So we're very encouraged to see the results of the study, hopefully, soon. And the important part about this study is really focused on the symptoms of the patients really, are we impacting what they see, when they eat food containing sugar. So we think we have a potentially differentiated product that a high affinity in IL15, it suppresses free IL15 rapidly, and it had immunogenicity to date.

在一項乳糜瀉挑戰研究中，我們給予單劑 TEV-408，然後 2 週後開始無麩質飲食 14 週。因此，我們很高興看到研究結果，希望很快就能看到。這項研究的重要部分實際上集中在患者的症狀上，當他們吃含糖的食物時，我們是否會影響他們所看到的東西。因此，我們認為我們擁有一種潛在的差異化產品，它對 IL15 具有高親和力，能夠快速抑制遊離 IL15，並且迄今為止具有免疫原性。

So on my final slide, I just want to talk about we're achieving our milestones and accelerating them where we can. We've shown that our olanzapine LAI today has achieved its primary endpoint, we'll be curious or hopeful to see the final set of the safety data on injections in the second half of this year. Our anti-TL1A program is right on target. The enrollment is going very well for both ulcerative colitis and Crohn's disease, and we'll be looking for that interim analysis in the second half of this year.

因此，在我的最後一張投影片中，我只想談談我們正在實現里程碑，並盡我們所能加速實現它們。我們已經證明，今天的奧氮平 LAI 已達到其主要終點，我們將很好奇或希望在今年下半年看到最終的注射安全數據集。我們的抗 TL1A 計劃是正確的。潰瘍性結腸炎和克隆氏症的入組進展順利，我們將在今年下半年進行中期分析。

I just mentioned our Anti-IL15 program, enrolling our Celiac patients this year in our proof-of-concept study. I'm very excited for the end of this month or the next month where we see a first patient in our anti-PD-1 IL2 program in oncology. And finally, we're enrolling our Phase III study now and working to accelerate our program for our dual action rescue inhaler for asthma. So a lot coming, and we're looking forward to keeping you updated.

我剛剛提到我們的抗 IL15 項目，今年將我們的乳糜瀉患者納入我們的概念驗證研究。我對本月底或下個月感到非常興奮，我們將在腫瘤學抗 PD-1 IL2 計畫中看到第一位患者。最後，我們現在正在進行 III 期研究，並努力加快我們的氣喘雙效救援吸入器計畫。即將推出的內容有很多，我們期待為您提供最新資訊。

So with that, I'm going to pass it off to Eli, and take it away.

因此，我要把它交給 Eli，然後把它拿走。

Thank you, Eric, and good morning and good afternoon to everyone. I'll begin my review of our Q1 2024 financial results with Slide 29, starting with our GAAP performance.

謝謝你，艾瑞克，祝大家早安，下午好。我將從幻燈片 29 開始回顧 2024 年第一季的財務業績，首先是我們的 GAAP 表現。

Revenue in the first quarter of 2024 were $3.8 billion, an increase of 4% in U.S. dollars and 5% in local currency terms compared to the first quarter of 2023. The increase was mainly driven by broad-based growth from generic products across all our segments globally, including strong contribution from generic segment made in the U.S., continued strong growth in AUSTEDO as well as AJOVY in our Europe and international markets segment. This was partially offset by lower revenue from COPAXONE as well as from ANDA, our distribution business in the U.S.

2024 年第一季的營收為38 億美元，與2023 年第一季相比，以美元計算成長4%，以當地貨幣計算成長5%。推動的。這被 COPAXONE 以及我們在美國的分銷業務 ANDA 的收入下降部分抵消。

In Q1 2024, we recorded a GAAP operating loss of $218 million compared to an operating loss of $13 million in the same quarter last year. The increase in operating loss was mainly due to higher impairments of tangible assets and other items as well as higher sales and marketing expenses in the first quarter of 2024, partially offset by higher gross profit, lower legal settlement and loss contingencies and lower intangible asset impairment in the first quarter of 2024.

2024 年第一季度，我們的 GAAP 營運虧損為 2.18 億美元，而去年同期的營運虧損為 1,300 萬美元。營業虧損增加主要是由於2024年第一季有形資產和其他項目減損增加以及銷售和行銷費用增加，但部分被毛利增加、法律和解和損失或有費用減少以及無形資產減損減少所抵銷2024年第一季。

As part of Teva's Pivot to Growth strategy, we have decided to divest our Generic business in Japan, which is part of Teva's International Markets segment. The assets and liabilities in relation to this business were classified as held for sale in the first quarter of 2024 and resulted in an impairment charge of approximately $600 million this quarter. We currently expect the business to be sold within the next year.

作為 Teva 成長策略的一部分，我們決定剝離日本的仿製藥業務，該業務是 Teva 國際市場部門的一部分。與該業務相關的資產和負債在 2024 年第一季被歸類為持有待售，導致本季產生約 6 億美元的減損費用。我們目前預計該業務將在明年內出售。

Moving to GAAP net loss, which was $139 million and GAAP loss per share was $0.12 this quarter compared to a loss per share of $0.20 in Q1 last year. The lower GAAP net loss was mainly due to a higher net loss related to noncontrolling interest, which resulted from higher tangible asset impairment related to the business that was classified as held for sale.

GAAP 淨虧損為 1.39 億美元，本季 GAAP 每股虧損為 0.12 美元，去年第一季每股虧損為 0.20 美元。公認會計準則淨虧損較低主要是由於與非控股權益相關的淨虧損較高，而非控股權益相關的淨虧損較高，這是由於與被分類為持有待售的業務相關的有形資產減值較高所致。

Turning to Slide 30. You can see the total non-GAAP adjustments in the first quarter of 2024 were $688 million compared to $661 million in Q1 2023. A notable non-GAAP adjustment includes legal expenses of $406 million, mainly related to estimated provisions recorded in connection with certain litigation cases in the U.S. Other notable adjustments include amortization, which is intangible assets of $152 million, the majority of which is included in cost of sales. And as I just mentioned, the impairment of tangible assets of approximately $600 million related to the business held for sale.

轉向投影片30。與記錄的估計撥備有關其他值得注意的調整包括攤銷，即 1.52 億美元的無形資產，其中大部分包含在銷售成本中。正如我剛才提到的，與待售業務相關的有形資產減損約為 6 億美元。

Now moving to Slide 31 for a review of our non-GAAP performance. As I mentioned earlier, our first quarter revenues were approximately $3.8 billion, an increase of 4% in U.S. dollars or 5% in local currency terms compared to Q1 of last year. Our non-GAAP gross profit margin was 51.4% compared to 49.1% in Q1 2023. This increase in our gross margin was mainly driven by improvement in our portfolio mix, including strong continued growth in AUSTEDO as well as decrease in our operational costs.

現在轉到幻燈片 31，回顧我們的非 GAAP 業績。正如我之前提到的，我們第一季的營收約為 38 億美元，與去年第一季相比，以美元計算成長了 4%，以當地貨幣計算成長了 5%。我們的非 GAAP 毛利率為 51.4%，而 2023 年第一季為 49.1%。

As expected and in line with the normal seasonality and revenue progression between the quarters, we started the year with a lower non-GAAP profit -- gross profit margin. For the full year of 2024, we continue to expect our non-GAAP gross margin to be between 53% to 54%. Our gross margin will gradually improve as we progress throughout the year driven by continuous improvement in our portfolio mix with a strong growth in our Innovative portfolio and continuation of the ongoing cost optimization program.

正如預期的那樣，並且與季度之間的正常季節性和收入進展一致，我們年初的非公認會計準則利潤（毛利率）較低。對於 2024 年全年，我們繼續預期非 GAAP 毛利率將在 53% 至 54% 之間。隨著我們全年的進步，我們的毛利率將逐步提高，這得益於我們的投資組合組合的持續改進、創新投資組合的強勁增長以及持續的成本優化計劃的持續。

Moving to non-GAAP operating margins in Q1 2024, which was 23.4% compared to 21.4% in Q1 2023. This increase was mainly driven by higher non-GAAP gross margin, as I just explained. This was partially offset by higher sales marketing expenses as a percentage of revenue, reflecting our increased investments to support our key growth engines including promotional activities related to AUSTEDO in line with our Pivot to Growth strategy. We ended the quarter with a non-GAAP earnings per share of $0.48 compared to $0.40 in Q1 2023, mainly driven by higher operating income.

2024 年第一季的非 GAAP 營業利潤率為 23.4%，而 2023 年第一季為 21.4%。這被較高的銷售行銷費用佔收入的比例所部分抵消，反映出我們增加了投資以支持我們的關鍵成長引擎，包括根據我們的成長策略開展與 AUSTEDO 相關的促銷活動。本季末，我們的非 GAAP 每股收益為 0.48 美元，而 2023 年第一季為 0.40 美元，這主要是由於營業收入增加。

The next slide shows our continuing efforts to transform and optimize our global manufacturing and operating footprint to drive efficiencies. During 2023, we closed 3 sites to bring our total footprint down to 49, and we have plans to continue this progress. By the end of 2025, we expect to close or divest 4 additional sites with a goal to bring down the total number of sites to between 40 to 42 sites by 2027. So we're really focused on continuing to optimize our operations to drive efficiencies and improve margins.

下一張投影片展示了我們為提高效率而持續努力轉型和優化我們的全球製造和營運足跡。 2023 年期間，我們關閉了 3 個站點，將總足跡減少到 49 個，我們計劃繼續這項進展。到 2025 年底，我們預計將關閉或剝離另外 4 個站點，目標是到 2027 年將站點總數減少到 40 至 42 個站點。

Turning to free cash flow on Slide 33. Our free cash flow in the first quarter of 2024 was $32 million. As a reminder, Teva's free cash flow tends to face headwinds at the start of the year due to the timing of annual bonus payments paid out in the first quarter of every year. In addition, our free cash flow for Q1 was also impacted by changes in certain working capital items.

轉向幻燈片 33 上的自由現金流。提醒一下，由於每年第一季支付年度獎金的時間，梯瓦的自由現金流往往在年初面臨阻力。此外，我們第一季的自由現金流也受到某些營運資金項目變動的影響。

Today, we are reaffirming our 2024 free cash flow guidance which we provided in January. Our 2024 free cash flow is expected to be in the range of $1.7 billion to $2 billion, and we expect this to pick up during the next 3 quarters, driven by ramp-up in our profitability as I mentioned earlier, and as we continue to drive working capital improvements.

今天，我們重申 1 月提供的 2024 年自由現金流指引。我們2024 年的自由現金流預計將在17 億至20 億美元之間，我們預計這一數字將在未來3 個季度內有所回升，正如我之前提到的，在我們盈利能力提升的推動下，隨著我們繼續推動營運資金改善。

Turning to Slide 34. Our net debt at the end of Q1 2024 was $16.7 billion compared to $16.6 billion at the end of '23. Our gross debt was $19.6 billion compared to $19.8 billion at the end of 2023. The decrease in our gross debt was mainly due to exchange rate fluctuations of $193 million. Our net debt to EBITDA slightly improved coming at 3.38x for Q1 2024, mainly due to higher EBITDA. Subsequent to the quarter close, in April 2024, we repaid $956 million of our senior notes at maturity at the end of March 31 and as of today, there is no amount outstanding under the $1.8 billion revolving credit facility.

轉向投影片 34。2024 年第一季末我們的淨債務為 167 億美元，而 2023 年末為 166 億美元。我們的總債務為 196 億美元，而 2023 年底為 198 億美元。 2024 年第一季度，我們的 EBITDA 淨債務略有改善，為 3.38 倍，這主要是由於 EBITDA 較高。 2024 年 4 月季度結束後，我們償還了 3 月 31 日到期的 9.56 億美元優先票據，截至今天，18 億美元循環信貸安排下沒有未償還金額。

Last week, Teva entered into an amendment to our revolving credit facility to update the company's maximum permitted leverage ratio under the RCF for a certain period. Under the amendment terms of the RCF, the company's leverage ratio shall not exceed 4x in '24 and '25 and in the first quarter of '26, 3.75x in the second, third and fourth quarter of 2026 and 3.5x in the first quarter of 2027 and onwards.

上週，梯瓦公司對我們的循環信貸安排進行了修訂，以更新公司在一定時期內 RCF 允許的最大槓桿率。根據RCF的修訂條款，公司的槓桿率在'24和'25以及'26第一季不得超過4倍，在2026年第二、第三和第四季為3.75倍，在第一季為3.5倍2027 年及以後。

Now let's turn our attention to our 2024 non-GAAP outlook on Slide 35. As we guided in January, when we initially provided our full year outlook, we had expected our revenue and earnings to progress gradually throughout the year. That continues to be our expectation, as we reported today. For the full year of 2024, we continue to expect our revenue to be between $15.7 billion to $16.3 billion. We are also reaffirming our 2024 non-GAAP outlook for operating income, EBITDA, earnings per share and free cash flow, as provided in January.

現在讓我們將注意力轉向幻燈片35 上的2024 年非GAAP 展望。進展。正如我們今天報導的那樣，這仍然是我們的期望。對於 2024 年全年，我們仍然預計我們的收入將在 157 億美元至 163 億美元之間。我們也重申了 1 月提供的 2024 年非公認會計原則營業收入、EBITDA、每股盈餘和自由現金流的展望。

Like I said earlier, our non-GAAP gross margin is expected to be between 53% to 54% for the full year and we expected a gradual pickup in margins in the second quarter, with a further progress in the second half of the year, in line with the revenue trajectory and the portfolio mix as well as improvement from our ongoing cost optimization program. In addition, we continue to make deliberate and thoughtful investments in our Innovative portfolio and to progress our key pipeline assets to drive both the short- and long-term growth for the company. Similar to gross margin improvement, we also expected to see leverage in operating expenses as a percentage of revenue in line with the ramp-up in the revenue as we progress throughout the year.

正如我之前所說，我們全年的非 GAAP 毛利率預計在 53% 至 54% 之間，我們預計第二季度利潤率將逐步回升，下半年將進一步取得進展，符合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。此外，我們繼續對創新投資組合進行深思熟慮的投資，並發展我們的關鍵管道資產，以推動公司的短期和長期成長。與毛利率的改善類似，我們也預計，隨著全年的進展，營運費用槓桿佔收入的比例將與收入的成長保持一致。

With this, I conclude my review of Teva's results for the first quarter of 2024. And now I will hand it back to Richard for a summary.

至此，我對 Teva 2024 年第一季業績的回顧結束了。

Thank you, Eli. Thank you for that. And so based on what we've told you today, we continue to be confident about hitting our 2027 guidance, 30% operating income margin, net debt 2x and cash to earnings 80% and a CAGR of mid-single digit. The reason why we remain confident about that, I can highlight on the next slide. It comes back to the execution of our strategy.

謝謝你，伊萊。謝謝你。因此，根據我們今天告訴您的情況，我們仍然有信心達到2027 年的指導目標，營業利潤率達到30%，淨債務翻倍，現金與收益比率達到80%，複合年增長率達到中個位數。我可以在下一張投影片中強調我們對此保持信心的原因。這又回到了我們戰略的執行。

As we laid out over a year ago, we had a plan to return to growth, accelerate growth and sustain growth. As you can see, we made good progress on return to growth, focusing on our growth engines, our biosimilars and getting our Generics business back to performance. To accelerate that, we clearly have the foundation for that with olanzapine readout today and our focus on ICS/SABA. We also have highlighted the number of biosimilars we have coming by 2027. So I think the momentum we're getting around Pivot to Growth continues to grow. And so that we remain optimistic about the future.

正如我們一年多前製定的那樣，我們制定了恢復成長、加速成長和維持成長的計劃。正如您所看到的，我們在恢復成長方面取得了良好進展，專注於我們的成長引擎、生物相似藥並使我們的仿製藥業務恢復績效。為了加速這一進程，我們顯然已經為今天的奧氮平讀數奠定了基礎，並且我們對 ICS/SABA 的關注。我們也強調了到 2027 年我們將推出的生物相似藥的數量。因此我們對未來保持樂觀。

With that, I welcome to take questions from people on the phone. Thank you.

在此，我歡迎大家在電話中回答問題。謝謝。

(Operator Instructions)

（操作員說明）

Our first question for today comes from Umer Raffat of Evercore ISI.

我們今天的第一個問題來自 Evercore ISI 的 Umer Raffat。

Congrats on the Phase III efficacy portion of the readout. I had 3 questions today, all 3, very trial-specific, if that's okay. First, I know the efficacy delta you're showing, placebo adjusted is about 9% to 10%. I know when Lilly ran their long-acting olanzapine, they were more in the mid-teens camp. Can you perhaps speak to what it is that clinicians want to see? Obviously, PDSS far trumped any sort of trial-to-trial differences in placebo-adjusted efficacy knowing that you also got to low teens in one of the arms.

祝賀讀數的 III 期療效部分。今天我有 3 個問題，全部 3 個，非常針對特定試驗，如果可以的話。首先，我知道你所顯示的功效增量，安慰劑調整後約為 9% 至 10%。我知道當禮來公司使用長效奧氮平時，他們更處於青少年陣營。您能否談談臨床醫師希望看到的是什麼？顯然，PDSS 遠遠超過了任何類型的安慰劑調整療效的試驗間差異，因為知道其中一隻手臂的療效也達到了十幾歲以下。

Secondly, I know the trial that we just saw is acute phase of the study and patients roll over to the safety. Is there any separate plans for a maintenance study as well? I think Lilly ran that and they ran the long-acting olanzapine. I'm curious if that impacts the indication. And then finally, I noticed when you guys developed UZEDY, which is the oral long -- sorry, which is a long-acting risperidone, there were some trial conduct issues, which led to FDA issuing a CRL because of some dosing errors and documentation issues, et cetera, volume of injection. And at the time, all the efficacy analyses ended up having to get either sensitivity analyses or potentially have to run a trial all over. Could you speak to how the trial conduct look different in this study in the efficacy portion versus the way UZEDY Phase III was run?

其次，我知道我們剛剛看到的試驗是研究的急性階段，病人會轉向安全階段。是否還有單獨的維護研究計畫？我認為禮來（Lilly）公司經營這個，他們經營長效奧氮平。我很好奇這是否會影響指示。最後，我注意到，當你們開發UZEDY 時，這是一種口服長效利培酮，抱歉，這是一種長效利培酮，存在一些試驗行為問題，導致FDA 由於一些劑量錯誤和文件而發布了CRL注射量等問題。當時，所有功效分析最終都必須進行敏感度分析，或者可能必須重新進行試驗。您能否談談本研究中的試驗行為在效能部分與 UZEDY III 期試驗的運作方式有何不同？

I'll hand that straight to Eric, over to you.

我會把它直接交給艾瑞克，交給你。

Yes. So Umer, thanks for the questions. Let me take the third one first, the CRL. So that was an issue around common problems you see in schizophrenia from studies where you sometimes get patients double-counted. We learned a lot from that issue in that study. We corrected that, and we actually monitored that extremely closely in the ongoing site. I would say that our ability to execute these sites is clearly one of the best in the industry. We brought this one up by 9 months and accelerated very, very well. And we review all the data very carefully. So that should not be an issue going forward.

是的。烏梅爾，謝謝你的提問。讓我先來看第三個，CRL。因此，這是一個圍繞精神分裂症常見問題的問題，這些問題有時會在研究中對患者進行重複計算。我們從該研究中的這個問題中學到了很多。我們糾正了這一點，並且實際上我們在正在進行的網站中非常密切地監控了這一點。我想說，我們執行這些網站的能力顯然是業內最好的之一。我們把這個提前了 9 個月，並且加速得非常非常好。我們非常仔細地審查所有數據。因此，這不應該成為未來的問題。

Now with regards to the deltas that we saw on our primary endpoint, that's the change in the PANSS score from baseline to week 8. So to be very blunt, these were deltas at exactly where we expect them to be. We were very pleased to see that the placebo behaved the way it should, which is something that is challenging in these studies every year, but ours seems to be run very well with regards to the lack of response in placebo and the delta we saw on each of the 3 doses. So you'll see that, that actually is very consistent with these exposures of olanzapine across many different studies.

現在，關於我們在主要終點上看到的增量，這是 PANSS 評分從基線到第 8 週的變化。我們很高興看到安慰劑的表現符合其應有的方式，這在每年的這些研究中都是一個挑戰，但我們的研究似乎運作得很好，因為安慰劑缺乏反應，而且我們在Delta 上看到了這一點。所以你會發現，這實際上與許多不同研究中奧氮平的暴露非常一致。

Now with regards to what the HCPs we look for, these are clinically significant changes. These are the expected deltas that a patient -- an investigator would want to see to be able to treat their patients. The real benefit here is we're getting the efficacy of olanzapine with just a single dose once a month in an easy subcutaneous injection. So that's the real benefit for the program, and we're excited to see the results today.

現在，就我們尋找的 HCP 而言，這些都是臨床上重大的變化。這些是患者（研究人員）希望看到能夠治療患者的預期增量。這裡真正的好處是，我們只需每月一次簡單的皮下注射，即可獲得奧氮平的功效。這就是該計劃的真正好處，我們很高興今天看到結果。

Our next question comes from David Amsellem from Piper Sandler.

我們的下一個問題來自 Piper Sandler 的 David Amsellem。

So just a couple of questions on biosimilars. So first, can you talk to -- and I apologize if I missed this earlier. Talk to the impact or how you're thinking about the impact of SIMLANDI as we move through the year with the Evernorth/Accredo contract. So how should we think about that? And then secondly, I know AbbVie, you talked about trying to enter into multiyear contracts. I think favorite phrase was with teeth.

關於生物相似藥的幾個問題。首先，你能談談——如果我之前錯過了這個，我深表歉意。隨著 Evernorth/Accredo 合約的臨近，談談影響或您如何看待 SIMLANDI 的影響。那我們該如何思考呢？其次，我知道艾伯維（AbbVie），您談到了嘗試簽訂多年合約。我認為最喜歡的短語是“牙齒”。

How are you thinking about how aggressive they're going to be over the long term in defending the brand and what you think that means for adoption of Humira biosimilars? So that's the second question. And then lastly, on the Stelara biosim, can you talk to -- and I know it's early and this is sort of a next-year question, but talk to how you're thinking about how that market is going to behave in terms of how aggressive the innovator is going to be with contracting and how you're thinking about adoption next year, particularly given that you're going to be launching very early on in biosimilar market formation?

您如何看待他們在長期捍衛該品牌方面將採取多積極的態度以及您認為這對 Humira 生物仿製藥的採用意味著什麼？這是第二個問題。最後，關於 Stelara Biosim，你能談談——我知道現在還為時過早，這是明年的問題，但談談你如何思考該市場將如何表現創新者在合約方面的積極性如何，以及您如何考慮明年的採用，特別是考慮到您將在生物相似藥市場形成的早期階段推出？

Thank you, David. Thanks for the question. So I'll take those. So how do we think about SIMLANDI this year? I think, firstly, we're excited to bring this to the market in Q2. What I would say and I sort of build a bit into your second question, the interest we're getting from payers and PBMs is very high. And I think there's been a change in the market versus last year where there's an appetite to really utilize the benefit that biosimilars bring to the market with containing health care costs long term.

謝謝你，大衛。謝謝你的提問。所以我會接受這些。那我們如何看待今年的 SIMLANDI？我認為，首先，我們很高興能在第二季將其推向市場。我想說的是，我在你的第二個問題中加入了一些內容，我們從付款人和 PBM 那裡得到的利息非常高。我認為與去年相比，市場發生了變化，人們希望真正利用生物相似藥為市場帶來的好處，並長期控制醫療成本。

So I think that dynamic is playing out. We obviously built a certain amount of SIMLANDI into our forecast for the year. It was risk-adjusted because there's many uncertainties. And obviously, we are launching this at this moment, not at the start of the year. So from a contracting point of view, that is something to take into account. But I would say, we remain optimistic about it. Let's see how it plays out.

所以我認為這種動態正在發揮作用。顯然，我們在今年的預測中加入了一定數量的 SIMLANDI。由於存在許多不確定性，因此進行了風險調整。顯然，我們是在此時推出此功能，而不是在今年年初。因此，從承包的角度來看，這是需要考慮的事情。但我想說，我們對此保持樂觀。讓我們看看結果如何。

And I think to your last question, how do we think about Stelara? Well, that's interesting from 2 factors. One is internal. So we have got the approval. So we're not going to be in the position where we are with biosimilar Humira coming to the market later. We'll be coming to the market at the start as you pointed out. That means we can have discussions with the payers, the PBMs, 6 months ahead of coming to the market, which is obviously beneficial.

我想問你的最後一個問題，我們如何看待 Stelara？嗯，這很有趣，有兩個因素。一是內部的。所以我們已經得到了批准。因此，我們不會處於生物相似藥 Humira 稍後上市的境地。正如您所指出的，我們將一開始就進入市場。這意味著我們可以在進入市場前 6 個月與付款人、PBM 進行討論，這顯然是有益的。

The other factor is, and I think this just shows the dynamic nature of the market. We talked about no penetration into the market last year with biosimilar Humiras in general. And now we're starting to see what I think is a more dynamic situation where things are changing, and we're definitely hearing that from the payers and the PBMs. So I believe there's a change in appetite and there's this change in strategic thinking but we'll have to see how that plays out. I think I've been consistent in saying I don't have a crystal ball on that. And that's why I think having a broad portfolio that you bring to the market is a sensible approach. But I would say, optimistic both for this year and optimistic for next year. Thanks for your question.

另一個因素是，我認為這正好顯示了市場的動態本質。去年我們談到生物相似藥 Humiras 總體上沒有滲透到市場。現在我們開始看到我認為更動態的情況，事情正在發生變化，我們肯定從付款人和 PBM 那裡聽到了這一點。因此，我相信需求發生了變化，戰略思維也發生了變化，但我們必須看看效果如何。我想我一直在說我對此沒有水晶球。這就是為什麼我認為將廣泛的產品組合推向市場是一種明智的做法。但我想說，對今年和明年都持樂觀態度。謝謝你的提問。

Our next question comes from Ash Verma of UBS.

我們的下一個問題來自瑞銀集團的 Ash Verma。

Congrats on all the progress. So I have to -- just a quick follow-up on biosimilar Humira. Do you think the Sandoz biosimilar Humira inflection is primarily because of CVS using an exclusionary contracting against the branded drug? And do you believe you can drive similar level of uptake just based of Cigna offering a $0 co-pay for biosimilars and but not necessarily getting into exclusionary contracting?

祝賀所有的進步。所以我必須——對生物仿製藥 Humira 進行快速跟進。您認為 Sandoz 生物相似藥 Humira 的變化主要是因為 CVS 對品牌藥使用排他性合約嗎？您是否相信僅憑 Cigna 為生物仿製藥提供 0 美元的自付費用，但不一定簽訂排他性合同，您就可以推動類似水平的採用？

And then on TAPI, I see on your website, you do provide like the API for semaglutide and tirzepatide injectables, like what is your level of scale here? And is that something that could be of interest to the GLP-1 players that are looking for significant supply expansion?

然後在 TAPI 上，我在你們的網站上看到，你們確實提供了索馬魯肽和替澤帕肽注射的 API，你們的規模是多少？正在尋求大幅擴張供應的 GLP-1 參與者是否會對此感興趣？

Thanks, Ash. Thanks for your call. That was good to talk. So with regard to the contracting, and it sort of goes back to my comment earlier about it's just very dynamic. It's really changed, I think, versus last year. So there are many different opportunities that are emerging, both in the normal channel and in this private label.

謝謝，阿什。感謝您的來電。聊得很好。因此，關於簽約，這有點回到我之前的評論，即它非常動態。我認為，與去年相比，情況確實發生了變化。因此，無論是在正常管道還是在自有品牌中，都出現了許多不同的機會。

And that's evolving almost weekly. So I think for us, that's encouraging. I don't want to try to predict how that's going to play out, whether people are going to mirror other people because I think it's quite individual. I think the bigger picture, which I am encouraged by is this appetite for biosimilars as a whole. And I think that plays out well for obviously us. It plays out well, I think, for patients and society in reducing costs long term.

而且這種情況幾乎每週都在改變。所以我認為這對我們來說是令人鼓舞的。我不想試圖預測事情會如何發展，人們是否會效仿其他人，因為我認為這是因人而異的。我認為更大的前景是對生物相似藥整體的需求，這讓我感到鼓舞。我認為這顯然對我們來說效果很好。我認為，從長遠來看，這對於患者和社會降低成本來說效果很好。

And I think everybody was waiting to see if something like this could happen. I don't think one swallow makes a summer, but I do think this is really interesting in progress. So that's how I would probably phase that. But obviously, when we speak in the next quarter earnings, I think we'll have more data and we'll continuously update you.

我想每個人都在等著看這樣的事情是否會發生。我不認為一隻燕子能構成一個夏天，但我確實認為這確實是一個非常有趣的進展。所以這就是我可能會分階段進行的方式。但顯然，當我們談論下個季度的收益時，我認為我們將獲得更多數據，並且我們將繼續向您更新。

With regard to the API and what you just raised there, I think that we don't go into specifics of each individual API and the potential for us to supply those and capacity. We obviously have lots of API that we manufacture and develop. So it's more complex than that. So that's probably the best way I can answer that question. But thanks for the questions, Ash.

關於 API 以及您剛剛提出的問題，我認為我們不會詳細討論每個 API 的細節以及我們提供這些 API 和容量的潛力。顯然，我們製造和開發了很多 API。所以它比那更複雜。所以這可能是我回答這個問題的最好方式。但謝謝你的提問，阿什。

Our next question comes from Balaji Prasad of Barclays.

我們的下一個問題來自巴克萊銀行的巴拉吉·普拉薩德。

So a couple from me, and apologies if some of these have been asked before. Richard, I had the opportunity to speak to often dozen neurologists recently. The general feedback I got was that (inaudible) AUSTEDO and they do want to use it for some of the indications, too. Generally, they think the feedback is that the insurance has been a challenge. And so I want to get your experience with payers and if there is scope for the commercial team to do better moving on?

我的一些建議，如果之前有人問過其中一些問題，我深感抱歉。理查德，最近我有機會經常與十幾位神經科醫生交談。我得到的一般回饋是（聽不清楚）AUSTEDO，他們也確實想將其用於某些適應症。一般來說，他們認為回饋是保險是一個挑戰。因此，我想了解您與付款人打交道的經驗，以及商業團隊是否有空間可以做得更好？

And two, can you also speak about the areas where you see off-label use or off-label potential for AUSTEDO and any plans around it? That's one. Two, on the biosimilar side, I couldn't help but notice that management commentary on biosimilars had softened in the last couple of months. Now that you are -- the approval of SIMLANDI and SELARSDI are behind you, would you want to revisit your expectations around biosimilars and how would SIMLANDI play through into your '24 guidance seeing that it's been reaffirmed even after that pro?

第二，您能否談談您認為 AUSTEDO 的標籤外使用或標籤外潛力的領域以及圍繞它的任何計劃？這是一個。第二，在生物相似藥方面，我不禁注意到過去幾個月管理層對生物相似藥的評論有所軟化。現在您已經獲得了 SIMLANDI 和 SELARSDI 的批准，您是否想重新審視您對生物仿製藥的期望？

Thanks, Balaji. Thanks for the questions and the interest. So on the first question, the [choice] challenge, actually, we're in a very good place with AUSTEDO and we're actually in a very good place with XR. So I don't think insurance is an issue and access is an issue. Now there's obviously pockets of that, that could be different. So depending on who you speak to, they can be. And I think XR is still lagging a bit behind our BID, but it's closing fast. But I think that's not something that I discuss regularly with the team. And by the way, it's not something I give them an excuse on when it comes to driving this business forward. So hopefully that answers that question.

謝謝，巴拉吉。感謝您的提問和興趣。因此，關於第一個問題，即[選擇]挑戰，實際上，我們在 AUSTEDO 方面處於非常好的位置，並且在 XR 方面我們實際上處於非常好的位置。所以我不認為保險是問題，而准入才是問題。現在顯然有一些東西，可能會有所不同。因此，取決於你與誰交談，他們可能是。我認為 XR 仍然落後於我們的 BID，但它正在快速接近。但我認為這不是我定期與團隊討論的事情。順便說一句，在推動這項業務向前發展時，我不會給他們藉口。希望這能回答這個問題。

With regards to off-label, obviously, I don't want to get into any discussions on that. I think we always want to make sure that the product is used within its label. So probably that's as much as I'll say.

關於標籤外，顯然，我不想對此進行任何討論。我認為我們始終希望確保產品在其標籤內使用。我大概就說這麼多了。

With regard to biosimilars, I sound smart in here because I don't think my language is interpreted a softening in the past. It's more about -- I think I've consistently said, this is an emerging market. This is dynamic, how this is going to play out. I don't want to try and predict because it can change all the time. It rarely happens, but maybe I was right on that one because it changed very quickly quite recently. So I think maybe I was more -- my language is more around how this market will evolve and as I said, I don't have a crystal ball. That is becoming clearer now, and that's probably why you're here. One, we have an approval of 2 of our biosimilars, so that's certainty, which I may not have had when we last spoke.

關於生物仿製藥，我在這裡聽起來很聰明，因為我不認為我的語言在過去被解釋為軟化。我想我一直在說，這是一個新興市場。這是動態的，這將如何發揮作用。我不想嘗試預測，因為它隨時都在變化。這種情況很少發生，但也許我的看法是對的，因為最近它變化得很快。所以我想也許我更多的是——我的語言更多的是關於這個市場將如何發展，正如我所說，我沒有水晶球。現在這一點變得更加清晰，這可能是你來這裡的原因。第一，我們的兩種生物相似藥已獲得批准，所以這是確定性的，而我們上次談話時我可能還沒有獲得批准。

The second thing is I do believe there's a change in the market. Now we'll see how that plays out across the whole market, but it does seem to be people are making interesting moves and the conversations we're having seem to have more purpose and energy than they've ever had. But we'll have to see how that plays out. It's interesting. But for us, it's about -- once we start to get contracts, once we start to ship volume and once we start to get revenue, it's meaningful, then we know there's been a significant change. And I think we'll see how that evolves as we go through the quarters of this year. But Balaji, thanks for your questions.

第二件事是我確實相信市場發生了變化。現在我們將看到整個市場的情況如何，但人們似乎確實正在做出有趣的舉動，我們正在進行的對話似乎比以往任何時候都更有目的和活力。但我們必須看看結果如何。這真有趣。但對我們來說，一旦我們開始獲得合同，一旦我們開始出貨，一旦我們開始獲得收入，這就是有意義的，然後我們就知道發生了重大變化。我想我們會在今年幾季看到這種情況如何發展。但是巴拉吉，謝謝你的提問。

Our next question comes from Jason Gerberry of Bank of America.

我們的下一個問題來自美國銀行的 Jason Gerberry。

First one for me is just on your 2024 guide. And I'm wondering really sort of what are the key variables to getting to the high end or even going through your guidance. It seems like with Humira, there's some upside optionality, but you guys are taking a conservative stance just on how that will get adopted. And I guess you have some exclusive generics that either haven't launched yet or haven't gotten market share on like Sandoz (inaudible) and Korlym.

對我來說，第一個就在你們的 2024 年指南上。我真的想知道達到高端甚至接受您的指導的關鍵變數是什麼。 Humira 似乎有一些很好的選擇，但你們在如何採用這一點上採取了保守的立場。我猜你們有一些尚未推出或尚未獲得市場份額的獨家仿製藥，例如 Sandoz（聽不清楚）和 Korlym。

So that's maybe an upside lever. So just wondering if you can comment on those dynamics if you agree with that characterization? And then secondly, just on the olanzapine LAI program, you have 20% of injections left. I'm just curious, the agreement with the FDA, was there any margin for error if you had a single PDSS event? I think the background rate was like 0.1%. So just kind of curious like if you got unlucky and there was like a single case, can you still avoid having the black box warning?

所以這可能是一個上行槓桿。所以想知道如果您同意這種描述，是否可以對這些動態發表評論？其次，就奧氮平 LAI 計劃而言，您還剩下 20% 的注射量。我只是好奇，與 FDA 達成的協議，如果發生一次 PDSS 事件，是否有任何誤差範圍？我認為背景率大約是 0.1%。所以我有點好奇，如果你運氣不好，只有一個案例，你還能避免出現黑框警告嗎？

Thanks, Jason. I'll take a stab at the first one, and maybe Eli can join, and then I'll hand over to Eric.

謝謝，傑森。我會嘗試第一個，也許 Eli 可以加入，然後我會交給 Eric。

So look, I think you sort of actually framed it really well. We have a bit of a range because we need to see how the biosimilars plays out. We have some product launches coming up, as you've highlighted in the U.S. Timing enough out of those, we have to see how those play out. And then we have to see how the momentum of our business plays out. So I think all of those -- some of those things were waited to happen. And as those start to happen, we'll get more clarity, and I think that gives us more opportunity to narrow the range, if that is what is required.

所以看，我認為你實際上把它框架得很好。我們有一些範圍，因為我們需要看看生物相似藥的效果如何。我們即將推出一些產品，正如您在美國所強調的那樣，這些產品的時機足夠，我們必須看看這些產品的效果如何。然後我們必須看看我們的業務動能如何發揮。所以我認為所有這些——其中一些事情都是等待發生的。隨著這些開始發生，我們將變得更加清晰，我認為這給了我們更多的機會來縮小範圍，如果這是需要的話。

But we think about it in a similar way to risk-adjusted biosimilars. We risk-adjusted some of our new product launches because they are based on timing and various other factors. And because of that, we think that's the prudent thing to do. As that changes and we get more certainty, we will come back very quickly and help you understand what that means and whether that means that the range narrows.

但我們以與風險調整生物相似藥類似的方式來思考它。我們對一些新產品的發布進行了風險調整，因為它們是基於時間和各種其他因素的。正因為如此，我們認為這是明智之舉。隨著這種情況發生變化並且我們獲得更多確定性，我們將很快回來並幫助您了解這意味著什麼以及這是否意味著範圍縮小。

Maybe Eli, would you like to add anything more?

也許 Eli，您還想補充什麼嗎？

No, I don't have anything to add.

不，我沒有什麼要補充的。

Good job, then. I'll hand that one to Eric down on the second one.

那麼乾得好。我會把第二個交給艾瑞克。

Yes. And there was a question about the PDSS and what are the discussions with the FDA. So the discussions we had were around 3,600 injections. That would be the point at which FDA was open to the discussion around not having this as a black box warning. We monitor this very closely. And I think it's important to start by saying, what's the scientific support and rationale and then what's the clinical data. Scientifically, it's very important to note that there's a completely different formulation. It's a subcutaneous formulation, not an intramuscular injection, which we might hit deep vessels. But on top of that, our formulation rapidly aggregates and keeps the API contained almost immediately after injection that has a slow release.

是的。還有一個關於 PDSS 的問題以及與 FDA 的討論內容。所以我們討論的是大約 3,600 次注射。到那時，FDA 將對不將此作為黑框警告的討論持開放態度。我們非常密切地關注這一情況。我認為首先要說的是，科學支持和基本原理是什麼，然後是臨床數據，這一點很重要。從科學角度來看，值得注意的是存在完全不同的配方。這是一種皮下製劑，而不是肌肉注射，我們可能會擊中深層血管。但最重要的是，我們的配方在註射後幾乎立即聚集並保持 API 的緩慢釋放。

So that supports the notion that we should not see PDSS. We have not seen it. Now, as you mentioned, we're up to about -- let's say we're up to about 2,700 injections now. So we're over the 80% mark. We haven't seen it. If we see one, that'll be a negotiation with FDA. The important thing is that we have an adjudication committee. So we should not see accidental PDSS at this point. And I think the science supports no PDSS.

這支持了我們不應該看到 PDSS 的觀點。我們還沒有看到它。現在，正如您所提到的，我們現在已經進行了大約 2,700 次注射。所以我們已經超過 80%了。我們還沒有看到它。如果我們看到這樣的情況，我們將與 FDA 進行談判。重要的是我們有一個評審委員會。所以此時我們不應該看到意外的 PDSS。我認為科學不支持 PDSS。

Our next question comes from Yifeng Liu of HSBC.

我們的下一個問題來自匯豐銀行的劉一峰。

I've got 3 questions. The first one is on olanzapine LAI. Could you just give us an update on the regulatory time lines and whether you have interest in filing outside the U.S.? Second one is on TL1A. Just could you talk about your kind of thinking about leveraging diagnostic tools, specifically companion diagnosis upon your product launch or as you go later in the pipeline?

我有 3 個問題。第一個是奧氮平 LAI。您能否向我們介紹一下監管時間表的最新情況以及您是否有興趣在美國境外提交申請？第二個是在 TL1A 上。您能否談談您對利用診斷工具的想法，特別是在產品發佈時或稍後進行的伴隨診斷？

And the third one is on biosimilar. And by the administration recently had some news about substitution without interchangeability. I just wonder, upon your next probably 6 or more biosimilar launch, how that will play a role in your plan and whether that is going to change anything in the studies you run? Any color on that would be great.

第三個是生物相似藥。政府最近有一些關於替代而不可互換的消息。我只是想知道，在您下一次可能推出 6 個或更多生物仿製藥時，這將如何在您的計劃中發揮作用，以及這是否會改變您進行的研究中的任何內容？任何顏色都會很棒。

Yifeng, thank you for the questions. I'll hand the first 2 to Eric, and then I'll take the third one.

逸風，謝謝你的提問。我會把前兩個交給艾瑞克，然後我會拿第三個。

Sure. Thank you for the question. So with regard to the olanzapine LAI program plans in the future. We're still running the long-term follow-up. We'll hopefully be presenting that data at a congress in the second half of this year. Other things drive submissions. We're planning to do the submission early in 2025 with our stability data on our product for preparedness. So that's the general time lines for olanzapine program.

當然。感謝你的提問。那麼關於奧氮平LAI計畫未來的計畫。我們仍在進行長期追蹤。我們希望在今年下半年的一次大會上展示這些數據。其他因素會推動提交。我們計劃在 2025 年初提交產品的穩定性數據，以做好準備。這就是奧氮平計劃的一般時間表。

With regard to TL1A and diagnostic tools, so we'll need to see the data. We're going to have our interim analysis to second half of this year. We are including all different biomarkers that we could interrogate with regards to serum biomarkers, biopsy biomarkers, proteomics and genomics on predicting response at baseline or on treatment. And we also have the 3 TL1A. So we have lots of data that we'll need to look at. If we find a diagnostic or a predictive value that could really help the program, we'll certainly use that. But our goal is to treat off-comers at this point because these patients need all the options they can get in both ulcerative colitis and Crohn's disease.

關於TL1A和診斷工具，所以我們需要查看數據。我們將在今年下半年進行中期分析。我們包括了所有不同的生物標誌物，我們可以在血清生物標記、活檢生物標記、蛋白質組學和基因組學方面詢問這些生物標誌物，以預測基線或治療時的反應。我們還有 3 台 TL1A。因此，我們有大量數據需要查看。如果我們找到真正可以幫助該程式的診斷或預測值，我們肯定會使用它。但我們目前的目標是治療不合格者，因為這些患者需要在潰瘍性結腸炎和克隆氏症方面獲得的所有選擇。

And the last question, I think you're going to handle with regards to the changes in the biosimilars plans by the FDA.

最後一個問題，我認為您將處理 FDA 生物仿製藥計劃的變化。

Yes. No. So around interchangeability, I think this is something that's been discussed, but it actually hasn't been concluded. So it's been proposed, but it has -- it needs to go to a required legislation to change for this to happen. So I think this -- I'd say, let's see how this plays out. Obviously, when it comes to substitution and allowing biosimilars to have a fast track uptake for patients and payers and society, we would support that. But there's a long way to go. So I think this is just at an embryonic stage, and we'll have to see how that plays out. And as there's more clarity, I'll update you on subsequent calls.

是的。不。所以它已經被提議，但它已經——它需要通過必要的立法來改變才能實現這一點。所以我認為——我想說，讓我們看看結果如何。顯然，當涉及替代品並允許生物相似藥為患者、付款人和社會快速採用時，我們會支持這一點。但還有很長的路要走。所以我認為這還處於萌芽階段，我們必須看看結果如何。隨著情況變得更加清晰，我將在後續電話會議中向您通報最新情況。

Our next question comes from Thibault Boutherin of Morgan Stanley.

我們的下一個問題來自摩根士丹利的蒂博·布瑟林。

Three questions. The first one, just a quick follow-up on biosimilars long term and your in-house pipeline. You mentioned the change in dynamics and how things are opening up for biosimilars. Is that changing in any way your willingness to invest in the kind of next generation of pipeline assets that you're developing internally?

三個問題。第一個，只是對生物相似藥的長期和內部管道的快速跟進。您提到了動態變化以及生物相似藥的發展。這是否會改變您投資內部開發的下一代管道資產的意願？

Second question, just on the olanzapine and market potential. I mean I think you gave in the past a kind of $400 million to $800 million potential for UZEDY. And given the broad use of olanzapine and clearly, your excitement on the asset, is it fair to think about blockbuster potential for olanzapine injectable? And last question, just on the prediction in the slides. We saw interest in the industry for biologic capacity elsewhere. So is there an opportunity for you to potentially diversify or monetize this site prediction exercise? Or is it just expected site closures?

第二個問題，關於奧氮平及其市場潛力。我的意思是，我認為您過去為 UZEDY 提供了 4 億至 8 億美元的潛力。考慮到奧氮平的廣泛用途，並且顯然，您對該資產感到興奮，考慮奧氮平注射劑的重磅炸彈潛力是否公平​​？最後一個問題，只是關於投影片中的預測。我們在其他地方看到了該行業對生物能力的興趣。那麼，您是否有機會使該網站預測活動多樣化或貨幣化？或只是預期的網站關閉？

Okay. Thank you, Thibault. Thank you for those questions. So let me start with the first one, the biosimilar one. I think it was around capital allocation. Do you see the change in dynamics mean that we would invest more in internal development. I think first and foremost, capital allocation occurs when we partner as well.

好的。謝謝你，蒂博。謝謝你提出這些問題。讓我從第一個開始，即生物相似藥。我認為這與資本配置有關。您是否看到動力的變化意味著我們將在內部發展上投入更多資金？我認為首先也是最重要的是，當我們合作時也會發生資本配置。

So obviously, we -- it's a lot less than when we do it internally. But I just want to make sure you're aware that we do allocate capital to our pipeline that is partnered, but it's less. I think we're in a very fortunate position at Teva because of the makeup of our business. And as you've seen from the Innovative pipeline that we have, that allocating capital to this and accelerating this through the clinic, I think, really drives potential to bring life-changing medicines to the market but also helps us drive value for shareholders. So I think we're always talking about our capital allocation. We take that into account as things change in our business, but I see nothing that creates a sizable shift in the strategy we have right now.

很明顯，我們——這比我們內部所做的要少得多。但我只是想確保您知道我們確實向合作管道分配了資金，但數量較少。我認為，由於我們業務的組成，梯瓦公司處於非常幸運的地位。正如您從我們擁有的創新管道中看到的那樣，我認為，為此分配資本並透過診所加速這一進程，確實推動了將改變生命的藥物推向市場的潛力，同時也有助於我們為股東創造價值。所以我認為我們總是在談論我們的資本配置。隨著我們業務的變化，我們會考慮到這一點，但我認為沒有任何事情會對我們目前的策略產生重大轉變。

Then I think you moved on to olanzapine and what's our prediction around this and could this be a blockbuster. Look, I go back to start with, there's clearly an unmet medical need there. There's no long-acting olanzapine as we've seen in the data. And clearly, a big percentage of patients would benefit from a long-acting olanzapine and we get the same feedback from health care positions which is one of the reasons why I think the study was so well recruited because people wanted to be part of it.

然後我認為您轉向了奧氮平，我們對此有何預測？看，我回到開始，那裡顯然存在著未滿足的醫療需求。正如我們在數據中看到的那樣，沒有長效奧氮平。顯然，很大一部分患者將受益於長效奧氮平，我們從醫療保健職位得到了相同的回饋，這就是我認為這項研究招募如此之多的原因之一，因為人們想參與其中。

I think when it comes down to giving guidance, obviously, we want to do a bit of work on understanding the dynamics of the environment, and we will come back and maybe give some bookends up to that later, as we've done with AUSTEDO in the past. So it's something which we're open to do. But we want to give that more time. And obviously, we wanted to get the safety and efficacy readout under our belt before we started to do that.

我認為，當談到提供指導時，顯然，我們希望在理解環境動態方面做一些工作，我們稍後會回來，也許會提供一些書立，就像我們對 AUSTEDO 所做的那樣在過去。所以這是我們願意做的事情。但我們想給予更多時間。顯然，我們希望在開始這樣做之前先了解安全性和有效性。

With regards to the divestment of sites and monetizing that, firstly, I'd say we've always done that. Teva runs very good sites. And the fact that we're reducing our sites is more about our strategy, not about the quality of those sites, the quality of the people who operate in those sites. And so on a regular occurrence, we divest and we sell our sites and people who find them very attractive. I think, obviously, you're talking about the change in environment around biologics and capacity. And so that's something that may make manufacturing sites easier to sell, but we'll see how that plays out over the next few years. Hopefully, that answers all your questions, Thibault. Thank you for them, and appreciate the interest.

關於網站的撤資和貨幣化，首先，我想說我們一直這樣做。 Teva 經營的網站非常好。我們減少站點的事實更多的是我們的策略，而不是這些站點的品質以及在這些站點中操作的人員的品質。因此，我們經常剝離並出售我們的網站和那些認為它們非常有吸引力的人。我認為，顯然，您正在談論圍繞生物製品和產能的環境變化。因此，這可能會讓生產基地更容易銷售，但我們將在未來幾年看看這將如何發揮作用。希望這能回答你所有的問題，蒂博。感謝他們，並感謝他們的興趣。

Our next question comes from Chris Schott of JPMorgan.

我們的下一個問題來自摩根大通的克里斯·肖特。

Just 2 questions for me. Maybe first, just on the international markets and just a 2 piece here. Can you just elaborate, particularly what markets are driving the healthy growth we're seeing here as you just think about that business as a whole? And I think as part of the prepared remarks, you talked about the Japanese generic business that you're divesting and just give us some sense of how large and the growth profile of that piece?

只要問我 2 個問題。也許首先，只是在國際市場上，這裡只有 2 件。您能否詳細說明一下，特別是當您考慮整個業務時，哪些市場正在推動我們在這裡看到的健康成長？我認為，作為準備好的演講的一部分，您談到了您正在剝離的日本仿製藥業務，只是讓我們了解該業務的規模和增長概況？

And then my second question was just coming back to TL1A, I kind of hear you in terms of the need for broad therapies given the unmet need in this space but does seem like a number of the KOLs we speak to are also excited about the potential for a biomarker-driven approach to help better identify patients. So I guess, your hands around, do you see the biomarker piece is something that's kind of secondary and that the studies will be kind of broad all-comers and that you'll kind of see how the biomarker sorts out?

然後我的第二個問題又回到了 TL1A，鑑於這個領域的需求未得到滿足，我聽到您說需要廣泛的療法，但似乎我們採訪過的許多 KOL 也對這種潛力感到興奮採用生物標記驅動的方法來幫助更好地識別患者。所以我想，你是否認為生物標記物是次要的，並且研究將是廣泛的所有參與者，並且你會看到生物標記物是如何排序的？

Or do you see there's a potential to differentiate on biomarkers? Because again, I'm just -- I'm trying to balance that out of kind of entrenched therapies. People want something that's a little bit different versus still again a lot of unmet need here.

或者您認為生物標記有區分的潛力嗎？因為我再次強調，我只是在嘗試用根深蒂固的療法來平衡這一點。人們想要一些有點不同的東西，而這裡仍然有很多未滿足的需求。

Chris, thanks for the questions. So with regards to your 2 international markets. Actually, the encouraging thing about international markets is we have growth across all of them. And we've had growth across all of them for the time I've been here, a credit to the team and the quality of the team. We have done a bit of focus on investing capital and resources more specifically, and I think that's really helped international markets. But there's not one that stands out. And I think that's what -- why we're delivering consistent quarter-on-quarter growth in international markets because of that.

克里斯，謝謝你的提問。關於你們的兩個國際市場。事實上，國際市場令人鼓舞的一點是我們在所有市場上都有成長。在我來到這裡的這段時間裡，我們在所有方面都取得了成長，這歸功於團隊和團隊的品質。我們更加重視投資資本和資源，我認為這確實對國際市場有幫助。但沒有一個是脫穎而出的。我認為這就是我們在國際市場上實現持續季度環比成長的原因。

Just with regard to the Japanese business, we're not stepping out of Japan. We're divesting part of our Generics business. And that goes back to once again to our capital allocation while we can make sure we're giving capital where we can generate a good return. And we have the ability to be thoughtful about that ever because of our scope in geographies and the businesses we have. So that's how that plays out in Japan. And now with TL1A, I'll hand that over to Eric to answer.

就日本業務而言，我們並沒有走出日本。我們正在剝離部分仿製藥業務。這又回到了我們的資本配置，同時我們可以確保我們在能夠產生良好回報的地方提供資本。由於我們的地理範圍和我們擁有的業務，我們有能力對此進行深思熟慮。這就是日本的情況。現在對於 TL1A，我將把這個問題交給 Eric 來回答。

Yes. Thank you for the question about biomarkers and TL1A. So the number of important things to consider when you're talking about biomarkers for one thing in my experience with biologics and discovery of biomarkers, it does take large numbers of patients to really understand and be confident in biomarkers effect. To date, we haven't seen significant delta based on biomarkers. I'd like to see much bigger delta based on many more patients.

是的。感謝您提出有關生物標記和 TL1A 的問題。因此，根據我在生物製劑和生物標記發現方面的經驗，當您談論生物標誌物時需要考慮的重要事項有很多，確實需要大量患者才能真正理解生物標誌物的效果並對之充滿信心。到目前為止，我們還沒有看到基於生物標記的顯著變化。我希望看到基於更多患者的更大增量。

But certainly, it's possible to identify biomarkers that are predictive of response at baseline. And more importantly, you can find strong ones that are predictive on treatment. So we're focused on speed. We're focused on making sure that people have options for these patients. Like we said, these patients cycle through treatment for ulcerative colitis and Crohn's disease, and they need options that last. So I don't want to disabuse patients as a possible treatment choice in the future. So the choice, we'll always look for these biomarkers, but it's going to take much more data than we have today.

但當然，有可能識別出可預測基線反應的生物標記。更重要的是，您可以找到對治療有預測作用的強有力的方法。所以我們專注於速度。我們致力於確保人們為這些患者提供選擇。正如我們所說，這些患者會經歷潰瘍性結腸炎和克隆氏症的治療週期，他們需要持久的選擇。所以我不想讓患者成為未來可能的治療選擇。因此，我們將始終尋找這些生物標誌物，但這將需要比現在更多的數據。

Our final question comes from Glen Santangelo from Jefferies.

我們的最後一個問題來自 Jefferies 的 Glen Santangelo。

Richard, I just want to shift gears for a second. In your prepared remarks, it kind of seemed like you're incrementally excited to talk about the Generics business this quarter. And when you look at the results, obviously, solid growth across all your geographies. Maybe could you just give us a little bit more details maybe about product launches that may be driving that growth? And how we should think about maybe organic volumes in that business and pricing? Just so to help us assess the durability of these recent trends?

理查德，我只想換個話題。在您準備好的發言中，您似乎對本季談論仿製藥業務感到越來越興奮。當你查看結果時，顯然，所有地區都實現了穩健成長。也許您能為我們提供更多有關可能推動成長的產品發布的詳細資訊嗎？我們應該如何考慮該業務的有機銷售和定價？只是為了幫助我們評估這些近期趨勢的持久性嗎？

And maybe as my follow-up, I've asked about Revlimid specifically. I know that created some volatility in the results in 3Q and 4Q last year based on your contracts for that business. And so I was curious if you could just give us an update there as well.

也許作為我的後續行動，我特別詢問了來那度胺（Revlimid）的情況。我知道，根據你們對該業務的合同，去年第三季和第四季的業績造成了一些波動。所以我很好奇您是否也可以提供我們最新情況。

Okay. Thanks for the question, Glen. I suppose I can't hide my excitement. And look, what's behind it? I appreciate the question. So I think I said at the outset when I write here at the Generics business at Teva having all the components to be a great business, which is why we use sustainable powerhouse as a pillar 3 of our strategy. That is not shying away from committing to something by calling it a powerhouse. The reason why we do that is we have an extensive pipeline of generics at Teva.

好的。謝謝你的提問，格倫。我想我無法掩飾我的興奮。看看，背後是什麼？我很欣賞這個問題。因此，我想我一開始就說過，當我在 Teva 仿製藥業務部門撰寫文章時，它擁有成為一家偉大企業的所有要素，這就是為什麼我們使用永續發展動力作為我們策略的第三支柱。這並不是因為稱之為強者而迴避致力於某件事。我們這樣做的原因是我們在 Teva 擁有廣泛的仿製藥產品線。

And we have a great high-quality manufacturing footprint, and we have a great go-to-market model. The lastly was not all of those are working in perfect harmony and they're still not, to be honest, but we're making big progress. And I think some of that comes down to new product launches that you've seen in Q4 that you've seen this year, and you will see more this year.

我們擁有出色的高品質製造足跡，並且擁有出色的上市模式。最後，並不是所有這些都完美和諧地工作，說實話，現在仍然不是，但我們正在取得巨大進展。我認為其中一些可以歸結為您在第四季度看到的新產品發布，今年您已經看到了，今年您將看到更多。

Hopefully, we don't always allow some other people to give us approval for those. That's one. And the second thing on our supply chain. Our supply chain is becoming more efficient and more able to deliver what is an ever-increasing demand. So those are things that make me excited. I don't think this is a linear projection. We're doing some hard work to make this happen. And I think each year, we'll get better and better and better, but we have the ingredients. And for me, this was the quarter that we started to see some of those things come together. And I don't think it will be, as I said, a clear path.

希望我們不要總是允許其他人批准我們的這些行為。這是一個。我們供應鏈上的第二件事。我們的供應鏈變得更有效率，更有能力滿足不斷成長的需求。這些都是讓我興奮的事。我認為這不是線性投影。我們正在做一些艱苦的工作來實現這一目標。我認為每年我們都會變得越來越好，但我們已經具備了要素。對我來說，這個季度我們開始看到其中一些事情結合在一起。正如我所說，我認為這不會是一條清晰的道路。

Your second about Revlimid, as you know, we don't split out our product sales. But I think Revlimid is a good example of the fact that when we get it right in R&D, when we get it right in our approach into the market first, we can maximize an asset. So I think that is something which we're benefiting from this year, but we're also benefiting some of our other launches that we've talked about in other calls. So thanks, Glen. Thanks for your question, and I appreciate it.

你的第二個關於來那度胺（Revlimid）的問題，如你所知，我們不會分割我們的產品銷售。但我認為 Revlimid 是一個很好的例子，說明當我們在研發方面做得正確時，當我們首先在進入市場時做得正確時，我們就可以最大化資產。所以我認為這是我們今年受益的事情，但我們也受益於我們在其他電話會議中討論過的其他一些發布。謝謝，格倫。謝謝你的提問，我很感激。

Thank you for everybody. I think the time is up now. I'd like to thank everybody for their participation and their interest in Teva Pharmaceuticals. I look forward to giving you an update for quarter 2 later in the year. Thank you.

謝謝大家。我想現在時間到了。我要感謝大家的參與以及對梯瓦製藥的興趣。我期待在今年稍後向您提供第二季的最新情況。謝謝。

Thank you all for joining today's call. You may now disconnect your lines.

感謝大家參加今天的電話會議。現在您可以斷開線路。