Teva Pharmaceutical Industries Ltd (TEVA) 2023 Q4 法說會逐字稿

Hello, and welcome to the Fourth Quarter and Full Year 2023 Teva Pharmaceutical Industries Earnings Conference Call. My name is Alex. I'll be coordinating the call today.

您好，歡迎參加梯瓦製藥工業 2023 年第四季和全年財報電話會議。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. Thank you, everyone, for joining us today. We hope you had an opportunity to review our press release, which was issued earlier this morning. A copy of this press release as well as a copy of the slides being presented on this call can be found on our website at tevapharm.com. Please review our forward-looking statements on Slide #2. Additional information regarding these statements and our non-GAAP financial measures is available on our earnings release and in our SEC Forms 10-K and 10-Q.

謝謝你，亞歷克斯。謝謝大家今天加入我們。我們希望您有機會閱讀我們今天早上早些時候發布的新聞稿。您可以在我們的網站 tevapharm.com 上找到本新聞稿的副本以及本次電話會議中簡報的投影片的副本。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 2023 full year 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 fourth quarter financial results in more detail, before providing an overview of Teva's 2024 financial outlook. 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 2023 年全年業績和業務績效、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四季度的財務業績，然後概述 Teva 的 2024 年財務前景。請注意，今天的通話將持續約 1 小時。

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

接下來，我會將電話轉給理查。理查德？

Thank you, Ran, and welcome, everybody. Thank you for joining the call today. 2023 was a transformational year for Teva. We launched the Pivot to Growth strategy to get Teva back to growth. And I'm pleased to say it did exactly that. Moving on to the next slide, here we are. Go back to slide, please. I'd like to remind you that the Pivot to Growth strategy was based on 4 pillars. This is one of our growth engines. Step up innovation, create Generics powerhouse and focus our business. And we're delivering on all 4 of these pillars as I will go through the presentation today. And obviously, you saw today that we've decided to divest our TAPI business, and I'll go into more detail later in the presentation.

謝謝你，蘭，歡迎大家。感謝您今天加入通話。 2023 年對 Teva 來說是轉型的一年。我們推出了「以成長為中心」策略，幫助 Teva 恢復成長。我很高興地說它確實做到了這一點。轉到下一張投影片，我們就在這裡。請返回幻燈片。我想提醒您，以成長為中心的策略是基於四大支柱。這是我們的成長引擎之一。加強創新，打造仿製藥強國並專注於我們的業務。正如我今天將介紹的那樣，我們正在實現所有這四個支柱。顯然，您今天看到我們決定剝離我們的 TAPI 業務，我將在稍後的演示中詳細介紹。

Now I will walk you through the numbers on this slide. I'm pleased to say, as I said, we got back to growth in Teva. I would also like to highlight the numbers include the Sanofi upfront payment as part of this collaboration, the ongoing development and commercialization of TL1-A. So terms of growth was 7% and got the sales revenue of $15.85 billion or if we take out Sanofi, it would be 3%. Adjusted EBITDA was up 5%, non-GAAP EPS up 2% and free cash flow up 6%. I'm also pleased to say we made progress on our net debt to EBITDA, and that now stands at 3.45%.

現在我將向您介紹這張投影片上的數字。我很高興地說，正如我所說，梯瓦公司恢復了成長。我還想強調這些數字，包括作為此次合作一部分​​的賽諾菲預付款、TL1-A 的持續開發和商業化。因此，成長率為 7%，銷售收入為 158.5 億美元，或如果我們剔除賽諾菲，則為 3%。調整後 EBITDA 成長 5%，非 GAAP 每股盈餘成長 2%，自由現金流成長 6%。我還很高興地說，我們的 EBITDA 淨債務取得了進展，目前為 3.45%。

Now on the next slide, I want to go to a bit more detail as to what was driving this performance. So I'm pleased to say that the innovative business performed well. AUSTEDO in particular, grew strongly at 28%, and AJOVY continues to show impressive performance with an 18% growth. With regards to our Generics business, we saw solid performance with Europe growing at 3% and international markets at 14%. And I'm pleased to see the stabilization of our North American Generics business as well.

現在，在下一張幻燈片中，我想更詳細地了解推動這種性能的因素。所以我很高興地說創新業務表現良好。尤其是 AUSTEDO，成長了 28%，AJOVY 繼續表現出色，成長了 18%。至於我們的仿製藥業務，我們看到了穩健的業績，歐洲成長了 3%，國際市場成長了 14%。我很高興看到我們的北美仿製藥業務也趨於穩定。

Now a bit more detail on what's driving behind these numbers, I'll start with AUSTEDO on the next slide. AUSTEDO hit its $1.2 billion guidance that we gave in the U.S., up 20-some percent and strong TRx was contributing to that. I'm pleased with this performance as it shows and clearly highlights the benefit of the additional resources we put behind the brand and the extra capabilities that we built.

現在，我將從下一張投影片上的 AUSTEDO 開始，詳細了解這些數字背後的推動因素。 AUSTEDO 達到了我們在美國給予的 12 億美元指導，成長了 20% 左右，強勁的 TRx 對此做出了貢獻。我對這一表現感到滿意，因為它顯示並清楚地突出了我們在品牌背後投入的額外資源以及我們構建的額外功能的好處。

And this gives you more confidence that as we move on to the next slide that I can reaffirm the guidance for 2027 to hit $2.5 billion. And a step in that direction is the guidance we're giving for 2024, which is a $1.5 billion revenue number. It's worth pointing out and remembering there are a significant amount of patients and people suffering from tardive dyskinesia that go undiagnosed. And we launched a direct-to-consumer campaign early January to help raise awareness and give these people an opportunity to get help and therapy.

這讓您更有信心，當我們進入下一張投影片時，我可以重申 2027 年達到 25 億美元的目標。我們為 2024 年提供的指導是朝這個方向邁出的一步，即 15 億美元的收入數字。值得指出並記住的是，有大量患有遲發性運動障礙的患者和人群並未被診斷出來。我們在一月初發起了一項直接面向消費者的活動，以幫助提高意識並為這些人提供獲得幫助和治療的機會。

Now moving on to the newest member of our family, UZEDY. We have good growth plan for UZEDY for 2024, and we're giving guidance of $80 million. And this is possible because of the work we did in 2023, where we drove awareness and access. We made good progress across the commercial payers as well as Medicare and Medicaid and ensuring (inaudible) awareness is good as feedback about the product profile and the fact that this fits the patient profile that they will be seeing.

現在讓我們來談談我們家族的最新成員 UZEDY。我們為 UZEDY 制定了 2024 年良好的成長計劃，並給出了 8000 萬美元的指導。這之所以成為可能，是因為我們在 2023 年所做的工作，我們提高了認知度和訪問量。我們在商業付款人以及醫療保險和醫療補助方面取得了良好的進展，並確保（聽不清）意識良好，作為對產品概況的反饋以及這符合他們將看到的患者概況的事實。

I'd also highlight the size of this market, it's a $4 billion market growing at 6%. So once again, I think UZEDY will contribute to growth this year and in the coming years as well.

我還要強調這個市場的規模，這是一個價值 40 億美元的市場，成長率為 6%。因此，我再次認為 UZEDY 將為今年和未來幾年的成長做出貢獻。

Now to move on to the last member of our innovative portfolio. That's AJOVY. We are very pleased with the continued momentum with 18% growth. And you see this growth across all of our regions.

現在轉到我們創新產品組合的最後一個成員。那是阿喬維。我們對 18% 的持續成長勢頭感到非常高興。您可以在我們所有地區看到這種增長。

In many geographies, we are gaining market share, which shows the true competitiveness of Teva. It is based on this good performance that we're giving a guidance for 2024, $0.5 billion for AJOVY.

在許多地區，我們正在獲得市場份額，這顯示了 Teva 的真正競爭力。正是基於這種良好的業績，我們為 AJOVY 提供了 2024 年 5 億美元的指引。

Now another aspect of our delivery on our growth engines and our strategies, our Biolojic Design portfolio, which I'd like to move on to now. I'd just like to highlight the fact that we will be launching 5 biosimilars in the next 4 years, which have an opportunity to contribute to our top and bottom line growth. Now when it comes to biosimilar HUMIRA, we are awaiting an FDA inspection result with our partner site that's based with our partner, Alvotech, it's a site based in Iceland. And based on the successful outcome here, we aim to launch biosimilar HUMIRA this year.

現在，我們交付成長引擎和策略的另一個方面是我們的 Biolojic 設計產品組合，我現在想繼續討論。我想強調的是，我們將在未來 4 年內推出 5 種生物相似藥，它們有機會為我們的營收和利潤成長做出貢獻。現在，說到生物相似藥 HUMIRA，我們正在等待 FDA 的檢查結果，我們的合作夥伴網站位於我們的合作夥伴 Alvotech，該網站位於冰島。基於這裡的成功成果，我們的目標是今年推出生物相似藥 HUMIRA。

Now moving on to the second pillar of our Pivot to Growth strategy and our pipeline. Eli Kalif will walk you through this in greater detail. Once again, with the strategy and the focus I've mentioned, we've really moved the needle. Olanzapine is completed, the recruitment is starting, and we expect the results in H2 of this year.

現在轉向我們的成長策略和管道的第二個支柱。 Eli Kalif 將帶您更詳細地了解這一點。再一次，透過我提到的策略和重點，我們確實取得了進展。奧氮平已經完成，招募工作正在啟動，預計今年下半年會有結果。

ICS/SABA entered the clinic in Q4 of last year. And as you can see, this is an attractive market where we think we have a differentiated product and there's only 1 other competitor. We have good momentum around TL1-A, and we're very excited about the partnership we have with Sanofi to really maximize this asset going forward.

ICS/SABA於去年第四季進入臨床。正如您所看到的，這是一個有吸引力的市場，我們認為我們擁有差異化的產品，並且只有 1 個其他競爭對手。我們圍繞 TL1-A 擁有良好的勢頭，我們對與賽諾菲的合作夥伴關係感到非常興奮，以真正最大限度地發揮這一資產的未來。

Now moving on to the third pillar of our strategy, our Generics and making this a Generics powerhouse. As I've said in the past, this is based on 3 specific areas we're focused on, making sure we have the right portfolio in the market that's been executed by commercial teams; focusing our pipeline so we can bring high-value products to grow the top and bottom line to the market on time more often; and also optimizing our network and actually the efficiency of our network.

現在轉向我們策略的第三個支柱，我們的仿製藥，並使之成為仿製藥的強大力量。正如我過去所說，這是基於我們關注的 3 個特定領域，確保我們在市場上擁有由商業團隊執行的正確投資組合；集中我們的產品線，以便我們能夠更頻繁地按時向市場推出高價值產品，以增加收入和利潤；並優化我們的網路以及實際上我們網路的效率。

I'll talk you through the pipeline, but I just want to just highlight the work we've done on our network. We have closed 3 sites in 2023, so we continue to rationalize and optimize that. And also, we have kicked off an operational excellence plan for 2024, where our aim is to reduce COGS and to allow us to drive gross margin expansion.

我將向您介紹整個流程，但我只想強調我們在網路上所做的工作。我們已於 2023 年關閉了 3 個站點，因此我們將繼續對其進行合理化和優化。此外，我們還啟動了 2024 年卓越營運計劃，目標是降低銷貨成本並推動毛利率擴張。

But now let me talk a bit about the pipeline because we have made some progress here. As you can see for this, when it comes to complex Generics, I think we're in a leading position in the U.S. Across multiple technologies and platforms we have and we can launch complex Generics products. We launched 10 between 2022 and 2023, but I'm excited by the 13 that we'll be launching between '24 and '25.

但現在讓我談談管道，因為我們在這裡取得了一些進展。正如您所看到的，當涉及複雜的仿製藥時，我認為我們在美國處於領先地位。在我們擁有的多種技術和平台上，我們可以推出複雜的仿製藥產品。我們在 2022 年至 2023 年期間推出了 10 個產品，但我對我們將在 24 年至 25 年之間推出的 13 個產品感到興奮。

And as you can see here highlighted on this slide, with the green circles, there's a number that we've already launched. So this has an opportunity for us to drive growth and offset some of the price erosion that obviously is there in the U.S. market.

正如您所看到的，這張投影片上突出顯示的綠色圓圈表示我們已經推出了一些產品。因此，這對我們來說是一個推動成長並抵消美國市場明顯存在的價格侵蝕的機會。

Now to move on to the final pillar and focusing our capital. Today, we announced the intention to divest Teva api. This is in line with our strategy and this will allow TAPI to realize its full potential in the world api market, which is valued at $85 billion. And subsequently allowed Teva to focus its capital on driving the Pivot to Growth strategy primarily focused on our innovative and Generics portfolio.

現在轉向最後一個支柱並集中我們的資本。今天，我們宣布打算剝離 Teva api。這符合我們的策略，將使 TAPI 充分發揮其在價值 850 億美元的世界 API 市場中的潛力。隨後，梯瓦得以將其資金集中用於推動成長策略，主要關注我們的創新和仿製藥產品組合。

Moving on to the next slide to give you a guide of the milestones that we have in 2024. It's pretty much more of the same, keep executing on the strategy, driving our innovative portfolio, as you see that $1.5 billion for AUSTEDO, keep driving the pipeline through the clinic to bring it to market as soon as possible and work on driving the efficiency in our launches and our manufacturing base in our Generics business and obviously, the work we'll be doing this year to divest TAPI at the end of this year, start of next year.

轉到下一張投影片，為您提供 2024 年里程碑的指南。這幾乎是一樣的，繼續執行策略，推動我們的創新投資組合，正如您看到的 AUSTEDO 15 億美元，繼續推動盡快將其推向市場，並努力提高仿製藥業務的上市和製造基地的效率，顯然，我們今年將在年底剝離TAPI今年，明年開始。

Moving on to my final slide. I'd like to announce our Healthy Future plan, which is a continuation of our ESG journey at Teva. Teva is focused on 3 main areas, and these divided are healthy people, and that's making sure we create access to medicines across the planet, making sure people have their medicines they needed at the right time and also making sure we have an inclusive and diverse culture at Teva.

繼續我的最後一張投影片。我想宣布我們的「健康未來」計劃，這是 Teva ESG 之旅的延續。 Teva 專注於3 個主要領域，這些領域都是健康人群，這確保我們在全球範圍內創造獲得藥物的機會，確保人們在正確的時間獲得所需的藥物，並確保我們擁有包容性和多元化的環境梯瓦的文化。

Secondly, Healthy Planet. This is really about Teva stepping up and helping minimize the impact of global warming with the many initiatives we've put in place. And finally, healthy (technical difficulty) everything we do at Teva is compliant and has the highest ethical standards.

其次，健康星球。這實際上是關於 Teva 加強並透過我們採取的許多舉措幫助最大限度地減少全球暖化的影響。最後，健康（技術難度），我們在 Teva 所做的一切都是合規的，並且具有最高的道德標準。

With that, I'll hand over this portion of the presentation to my colleague, Eric Hughes.

接下來，我會將簡報的這一部分交給我的同事 Eric Hughes。

Thank you, Richard. Moving on to the slide for AJOVY. We know physicians choose AJOVY because of its safety and efficacy as well as its convenient auto-injector, monthly dosing (technical difficulty) but today, I'm excited to show you our recent data that we produced from 2 real-world evidence studies, PEARL and FINESSE, showing the durability of AJOVY.

謝謝你，理查。繼續看 AJOVY 的幻燈片。我們知道醫生選擇AJOVY 是因為它的安全性和有效性，以及方便的自動注射器、每月給藥（技術難度），但今天，我很高興向您展示我們從2 項真實世界證據研究中得出的最新數據， PEARL和FINESSE，展現AJOVY的耐用性。

Migraine is a chronic disease and having durability of response is very important. And what we can see in this study is that the days that you're free of migraine has been maintained for 2 years after starting AJOVY. This is very important.

偏頭痛是一種慢性疾病，反應的持久性非常重要。我們在這項研究中可以看到，在開始使用 AJOVY 後，沒有偏頭痛的日子可以維持 2 年。這個非常重要。

And this translates not only to just a simple reduction in monthly migraines, but it really is 8 full days for some patients to achieve a day without migraine. So each month, a patient gets back about a week of their life without migraine. So very important.

這不僅意味著每月偏頭痛的減少，而且對於某些患者來說，實際上需要 8 天才能實現一天沒有偏頭痛。因此，每個月，患者都會恢復約一週的偏頭痛症狀。所以非常重要。

Moving on to our slide for UZEDY. As Richard mentioned, we are very excited to get the approval last year and launch UZEDY. And we're also happy to show more durability of UZEDY as well. Here, following up on subjects from our pivotal study, we show that the quality of life in patients not only are maintained up to 56 weeks, but also slightly improved. So this is very important as well for patients with schizophrenia because we had patients with long duration of disease, the short durations of disease but we can show here that the long acting injectable, we could actually not only maintain but improve their quality of life.

繼續我們的 UZEDY 幻燈片。正如理查德所提到的，我們非常高興去年獲得批准並推出 UZEDY。我們也很高興展示 UZEDY 的耐用性。在這裡，我們對關鍵研究的受試者進行跟踪，結果表明患者的生活品質不僅可以維持長達 56 週，而且還略有改善。因此，這對精神分裂症患者也非常重要，因為我們有病程長、病程短的患者，但我們可以在這裡表明，長效注射劑實際上不僅可以維持而且可以改善他們的生活品質。

This is important for long-acting injectables because we believe this is important to maintain the exposure in the patient's blood to the risperidone. So we think this is very important. We're happy to see this durability of response.

這對於長效注射劑很重要，因為我們相信這對於維持患者血液中利培酮的暴露很重要。所以我們認為這是非常重要的。我們很高興看到這種持久的回應。

Moving on to AUSTEDO. One of the things that's important for AUSTEDO,and as Richard mentioned, there's very much a room to grow and access patients who have tardive dyskinesia. And one of the things we need to do is make sure it is easy and convenient to use AUSTEDO as possible. We know in real world evidence that only about 50% of our patients without a titration pack can achieve the dose range that is necessary to get good at.

繼續前往 AUSTEDO。對於 AUSTEDO 來說重要的事情之一，正如理查德所提到的，有很大的成長空間和接觸患有遲發性運動障礙的患者。我們需要做的事情之一就是確保 AUSTEDO 的使用盡可能簡單方便。我們知道，現實世界的證據表明，在沒有滴定包的情況下，只有約 50% 的患者能夠達到擅長所需的劑量範圍。

So we ran a study (technical difficulty) and we were pleased to see that 78% of the subjects could finish the titration pack, and we're 90% and 87% adherent. And this is important because getting to the titration pack easily and simply for patients gets those patients up into the right dose ring that makes sure that we get our patients the right efficacy. And we hope this translates into durability and adherence for long-term treatment. So very important, and we're glad to see this works so well for our patients.

因此我們進行了一項研究（技術難度），我們很高興地看到 78% 的受試者能夠完成滴定包，而我們的堅持率分別為 90% 和 87%。這很重要，因為對於患者來說，輕鬆簡單地使用滴定包可以讓患者進入正確的劑量環，確保我們為患者提供正確的療效。我們希望這能轉化為長期治療的持久性和依從性。非常重要，我們很高興看到這對我們的患者非常有效。

Finally, I just want to review our milestones in the R&D organization. We are doing well in our enrollment for our Phase II study TL1-A, and it's accelerating. We're looking forward to that Phase II interim analysis in the second half of 2024. We are fully enrolled in our olanzapine LAI Phase III globally, and we'll be having our full clinical package of efficacy and safety in the second half of 2024.

最後，我想回顧一下我們在研發組織中的里程碑。我們的 II 期研究 TL1-A 的註冊工作進展順利，並且正在加速。我們期待在 2024 年下半年進行 II 期中期分析。我們已在全球範圍內全面註冊奧氮平 LAI III 期臨床試驗，我們將在 2024 年下半年獲得完整的療效和安全性臨床資料包。

Our anti IL-15 program is finishing up its Phase I SAD and MAD study in healthy volunteers, and we'll present that data in the second half of this year, and we'll also finish enrollment of a proof-of-concept study in celiac patients by the end of this year. We're excited to look forward to the first-in-human dosing of our anti-PD-1 IL-2 program in the first half of this year. And finally, we're actively enrolling our Phase III study in ICS/SABA and looking forward to those results in the second half of 2026.

我們的抗 IL-15 計畫正在完成在健康志願者中進行的 I 期 SAD 和 MAD 研究，我們將在今年下半年提供這些數據，我們還將完成概念驗證研究的招募到今年年底在乳糜瀉患者中。我們很高興期待今年上半年我們的抗 PD-1 IL-2 計畫首次人體給藥。最後，我們正在 ICS/SABA 中積極進行 III 期研究，並期待在 2026 年下半年獲得這些結果。

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

接下來，我會將其轉交給 Eli Kalif。

Thank you, Eric, and good morning and good afternoon to everyone. I'll begin a review of our 2023 financial results with our main focus being on fourth quarter performance. This will be followed by our non-GAAP outlook for 2024 and same -- and some of the important assumptions behind it.

謝謝你，艾瑞克，祝大家早安，下午好。我將開始回顧我們 2023 年的財務業績，主要關注第四季度的業績。接下來是我們對 2024 年的非 GAAP 展望以及背後的一些重要假設。

Beginning on Slide 24, I would like to remind everyone that in October 2023, Teva entered to an exclusive collaboration with Sanofi to develop and commercialize Teva's anti-TL1-A asset. As per the terms of the collaboration agreement, Teva received an upfront payment of $500 million in the fourth quarter of 2023, which was recognized as license arrangement revenues. This upfront payment had a positive contribution of $500 million to both our revenue and free cash flow.

從投影片 24 開始，我想提醒大家，2023 年 10 月，Teva 與賽諾菲達成獨家合作，開發 Teva 的抗 TL1-A 資產並將其商業化。根據合作協議條款，Teva 在 2023 年第四季收到了 5 億美元的預付款，該筆款項被確認為授權安排收入。這筆預付款為我們的收入和自由現金流帶來了 5 億美元的積極貢獻。

After adjusting for certain transactions-related costs, this payment had a positive contribution of approximately $430 million. Now throughout the presentation, I will be discussing our results for the quarter and for the full year 2023 as reported.

在調整某些交易相關成本後，這筆款項產生了約 4.3 億美元的正面貢獻。現在，在整個演示過程中，我將討論我們報告的本季和 2023 年全年的業績。

Also, I want to draw your attention to the disclosure we included in the press release this morning regarding the revision to certain GAAP financial metrics in 2022 and 2023 to correct errors related to contingent consideration liability. This provision did not impact our non-GAAP results for either year.

另外，我想提請您注意我們今天早上在新聞稿中披露的有關修訂 2022 年和 2023 年某些 GAAP 財務指標的披露，以糾正與或有對價負債相關的錯誤。這項規定並沒有影響我們任何一年的非公認會計準則表現。

Now starting with our Q4 GAAP performance. Revenue in the fourth quarter of 2023 were $45 million, an increase of 15% in U.S. dollars and 14% in local currency terms compared to the fourth quarter of 2022. The increase was mainly driven by the upfront payments that I just mentioned, the sale of certain product rights in Europe segment, continued strong growth in AUSTEDO and higher revenue from Generics products in international markets.

現在從我們第四季度的 GAAP 業績開始。 2023年第四季的營收為4,500萬美元，與2022年第四季相比，以美元計算成長了15%，以當地貨幣計算成長了14%。這一成長主要是由我剛才提到的預付款推動的，即銷售歐洲部分的某些產品權利、AUSTEDO 的持續強勁增長以及國際市場仿製藥產品的收入增加。

This was partially offset by lower revenue from Generics products and our distribution business in North America and from COPAXONE. In Q4 2023, we recorded a GAAP operating income of $755 million compared to an operating loss of $940 million in the same quarter last year.

這被仿製藥產品和我們在北美的分銷業務以及 COPAXONE 的收入下降所部分抵消。 2023 年第四季度，我們的 GAAP 營業收入為 7.55 億美元，而去年同期的營業虧損為 9.4 億美元。

The increase in operating income was mainly due to goodwill impairment charges in the fourth quarter of 2022 and higher gross profit (technical difficulty) this year, partially offset by higher impairments, restructuring and other items in the fourth quarter of 2023 with a net income of $461 million and GAAP earnings per share of $0.41 which was higher than last year, mainly driven by higher operating income, as I just explained.

營業收入的增加主要是由於2022年第四季的商譽減損支出和今年較高的毛利（技術難度），部分被2023年第四季較高的減損、重組和其他項目所抵消，淨利潤為正如我剛才所解釋的，4.61 億美元和 GAAP 每股收益為 0.41 美元，高於去年，主要是由於營業收入增加所致。

Turning to Slide 25, you can see the non-GAAP adjustment in the fourth quarter of 2023 and notable adjustments this quarter included a contingent consideration expenses of $408 million, mainly related to the change in the estimated future royalty payments in connection with Generics revenue.

轉向幻燈片25，您可以看到2023 年第四季的非GAAP 調整，本季的顯著調整包括4.08 億美元的或有對價費用，主要與仿製藥收入相關的預計未來特許權使用費的變化有關。

Now moving to Slide 26 for a review of our non-GAAP performance. As I mentioned earlier, our fourth quarter revenue were approximately $4.5 billion, our annual revenue in 2023 were $15.8 billion, an increase of 6% in U.S. dollars or 7% in local currency terms compared to 2022. Excluding the contribution from upfront payments regarding our anti-TL1-A collaboration, our revenue growth in 2023 was 3%.

現在轉到幻燈片 26，回顧我們的非 GAAP 業績。正如我之前提到的，我們第四季的營收約為45 億美元，2023 年的年收入為158 億美元，與2022 年相比，以美元計算成長6%，以當地貨幣計算成長7%。不包括我們的預付款貢獻抗 TL1-A 合作，我們 2023 年的營收成長為 3%。

Now let's move down the P&L, starting with the gross profit margin. Our non-GAAP gross profit margin was 58.2% compared to 54.2% in Q4 2022. The increase in our gross margin was mainly due to the upfront payment, as I just mentioned, and a favorable portfolio mix as well as the sale of certain products drive in Europe and part of our portfolio rationalization. This was partially offset by higher costs related to inflationary and other macroeconomic pressures.

現在讓我們從毛利率開始降低損益表。我們的非 GAAP 毛利率為 58.2%，而 2022 年第四季為 54.2%。毛利率的成長主要是由於我剛才提到的預付款、有利的投資組合以及某些產品的銷售推動歐洲業務以及我們投資組合合理化的一部分。這被通貨膨脹和其他宏觀經濟壓力相關的成本上升部分抵消。

Excluding the impact of the upfront payment, our non-GAAP gross profit margin would have been consistent with the levels of Q3. This was slightly below our expectation, mainly due to timing effects related to a certain element of our costs associated with the inventory consumption, our portfolio mix and better-than-expected performance of our low-margin distribution business as well as an unfavorable impact from hedging activities.

排除預付款的影響，我們的非公認會計原則毛利率將與第三季的水平一致。這略低於我們的預期，主要是由於與庫存消耗、我們的投資組合組合和低利潤分銷業務的業績好於預期的某些成本因素相關的時間效應，以及來自以下因素的不利影響：對沖活動。

Overall, we saw a sustainable improvement in our gross profit margin since the first quarter of 2023, with stabilization of the margins in the second half of 2023.

整體而言，自 2023 年第一季以來，我們的毛利率持續改善，2023 年下半年利潤率趨於穩定。

Going forward in 2024, we expect our gross margin to continue to improve, driven by continuous improvement in our portfolio mix with a strong growth in our innovative portfolio as well as continuation of the optimization program we have initiated. We expect that our non-GAAP gross profit margin to be between 53% to 54% in 2024 full year. Similar to 2023, we expect gross margin to gradually improve throughout this year.

展望2024年，我們預計我們的毛利率將繼續提高，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我們啟動的優化計劃的持續。我們預計 2024 年全年非 GAAP 毛利率將在 53% 至 54% 之間。與 2023 年類似，我們預計今年毛利率將逐步改善。

Moving to the non-GAAP operating margin in Q4 2023, which was 34.7% compared to 29.1% in Q4 2022. This increase was mainly driven by higher non-GAAP gross profit margin, as I just explained as well as lower operating expenses as a percentage of revenue. On an absolute basis, our higher operating expenses this quarter were related to higher investment in R&D and sales marketing, in line with our Pivot to Growth strategy, partially offset by efficiencies in our (technical difficulty). We ended the quarter with earnings per share of $1 compared to $0.71 in Q4 2022, mainly driven by higher operating income.

轉向2023 年第四季的非GAAP 營業利潤率，該利潤率為34.7%，而2022 年第四季為29.1%。這一增長主要是由更高的非GAAP 毛利率推動的，正如我剛才所解釋的，以及較低的營業費用收入的百分比。從絕對角度來看，我們本季較高的營運費用與研發和銷售行銷的較高投資有關，這符合我們的「以成長為中心」策略，部分被我們（技術難度）的效率所抵銷。本季末，我們的每股盈餘為 1 美元，而 2022 年第四季為 0.71 美元，主要是由於營業收入增加。

Turning to free cash flow on Slide 27. Our free cash flow in the fourth quarter of 2023 was $1.5 billion compared to $1.1 billion in Q4 2022. In addition to the (technical difficulty) sales driven by EBITDA items, partially offset by the sale of accounts receivable under our U.S. -- facility in the fourth quarter of 2022. During the fourth quarter of 2023, we also initiated the first payment of the nationwide settlement in connection with the (inaudible) litigation that increased our total payments of legal settlements by approximately $244 million compared to Q4 2022. Overall, the full year of 2023 free cash flow was $2.4 billion compared to $2.2 billion in 2022.

轉向幻燈片27 上的自由現金流。我們2023 年第四季的自由現金流為15 億美元，而2022 年第四季為11 億美元。除了EBITDA 專案驅動的（技術難度）銷售外，部分被銷售2022 年第四季度我們在美國設施下的應收帳款。在2023 年第四季度，我們還啟動了與（聽不清楚）訴訟有關的全國和解的第一筆付款，該訴訟使我們的法律和解總付款增加了約與 2022 年第四季相比為 2.44 億美元。總體而言，2023 年全年自由現金流為 24 億美元，而 2022 年為 22 億美元。

Turning to Slide 28. We continue to make strong progress in terms of reducing our debt. Our net debt at the end of Q4 2023 was $16.6 billion compared to $18.4 billion at the end of 2022. Our gross debt was $19.8 billion compared to $21.2 billion at the end of 2022. The decrease in our gross debt was mainly due to $1.6 billion repaid maturity partially offset by $102 million of exchange rate fluctuations.

轉向幻燈片 28。我們在減少債務方面繼續取得重大進展。截至2023 年第四季末，我們的淨債務為166 億美元，而2022 年底為184 億美元。我們的總債務為198 億美元，而2022 年底為212 億美元。總債務減少主要是由於16 億美元到期償還額被 1.02 億美元的匯率波動部分抵銷。

During Q4 2023, we repaid the full $500 million under our $1.8 billion revolving credit facility. And as of December 31 and as of today, there is no amount outstanding under the revolver. As a result, our net debt to EBITDA also improved, coming in at 3.45x for Q4 2023. As part of our capital allocation strategy, we expect our net debt reduction to continue as we continue to grow progress towards our long-term target of 2x net debt to EBITDA by end of 2027.

2023 年第四季度，我們償還了 18 億美元循環信貸額度下的全部 5 億美元。截至 12 月 31 日和今日，左輪手槍項下沒有未償還金額。因此，我們的 EBITDA 淨債務也有所改善，2023 年第四季為 3.45 倍。作為我們資本配置策略的一部分，我們預計隨著我們繼續朝著長期目標邁進，我們的淨債務將繼續減少。到2027年底，EBITDA 淨債務將達2 倍。

Now let's turn our attention to 2024 non-GAAP outlook. As Richard mentioned, 2023 was a pivotal year for Teva. And throughout the year, our products around the world worked very hard to execute on our Pivot to Growth strategy. We made some deliberate choices and began investing in our growth drivers and our promising pipeline while also navigating and addressing the impact of the macroeconomic and geopolitical headwinds.

現在讓我們將注意力轉向 2024 年非 GAAP 展望。正如理查德所提到的，2023 年對 Teva 來說是關鍵的一年。在這一年裡，我們在世界各地的產品都非常努力地執行我們的「以成長為中心」策略。我們做出了一些深思熟慮的選擇，並開始投資我們的成長動力和有前景的產品線，同時也應對宏觀經濟和地緣政治逆風的影響。

As we move to 2024, we remain focused to continue to execute on our long-term strategy. With this in mind, we began with 2024 total revenue which we expect to be between $15.7 billion and $16.3 billion. Compared to 2023, this represents a growth of 2% to 6%, excluding the $500 million, the upfront payment receipt related to our TL1-A assets.

邁入 2024 年，我們仍然專注於繼續執行我們的長期策略。考慮到這一點，我們預計 2024 年總收入將在 157 億美元至 163 億美元之間。與 2023 年相比，這意味著成長 2% 至 6%，不包括與我們的 TL1-A 資產相關的 5 億美元預付款收據。

As Richard mentioned earlier, our revenue growth will be driven by continued strong momentum in our innovation -- innovative portfolio and stabilize Generics business. Coming to our non-GAAP operating profit, we expect our gross margin to gradually improve throughout 2024 as we continue to execute our Pivot to Growth strategy, was to continue to make deliberate investments in our innovative portfolio and progress our key pipeline assets to drive both short- and long-term growth for the company.

正如理查德之前提到的，我們的收入成長將受到我們創新的持續強勁動力——創新產品組合和穩定的仿製藥業務的推動。談到我們的非公認會計原則營業利潤，我們預計我們的毛利率將在2024 年逐步提高，因為我們繼續執行我們的「以成長為中心」策略，即繼續對我們的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。

With that in mind, we expect our operating expenses to be approximately 27% to 27.5% for the full year, including R&D expenses between 6% to 6.5% of revenue. As a result, our non-GAAP operating income is expected to be between $4 billion and $4.5 billion and our non-GAAP adjusted EBITDA is expected to be between $4.5 billion to $5 billion, both growing over 2023 levels, excluding the effect of the upfront payment. We expect finance expenses to be approximately $1 billion in 2024, in line with 2023 levels.

考慮到這一點，我們預計全年營運費用約為27%至27.5%，其中研發費用佔收入的6%至6.5%。因此，我們的非GAAP 營業收入預計將在40 億至45 億美元之間，我們的非GAAP 調整後EBITDA 預計將在45 億至50 億美元之間，兩者都將超過2023 年的水平，不包括預付款的影響。支付。我們預計 2024 年的財務費用約為 10 億美元，與 2023 年的水準一致。

Looking at our tax rate, we expect our non-GAAP tax rate to be (technical difficulty) slightly higher than the tax rate of 13%, which benefited partially due to intellectual property-related integration plan and carryforward losses. This brings us to expected a non-GAAP earnings per share in the range of $2.20 to $2.50. We expect our 2024 free cash flow to be in the range of $1.7 billion to $2 billion. We do not provide quarterly guidance, but I thought it will be helpful to share how we are thinking about the progression throughout the year.

從我們的稅率來看，我們預期我們的非 GAAP 稅率（技術難度）略高於 13% 的稅率，部分受益於與智慧財產權相關的整合計畫和結轉損失。這使我們預計非 GAAP 每股收益在 2.20 美元至 2.50 美元之間。我們預計 2024 年的自由現金流將在 17 億至 20 億美元之間。我們不提供季度指導，但我認為分享我們如何思考全年的進展將會有所幫助。

Overall, based on our expectation today, we expect revenue and earnings to progress gradually during the year, with the revenue in the second half of 2024 to be slightly higher than the first half. Our non-GAAP margins are also expected to (technical difficulty) throughout the year, in line with the revenue trajectory as well as improvements from our optimization program we have initiated.

整體而言，根據我們今天的預期，我們預計年內收入和獲利將逐步進步，2024年下半年的營收將略高於上半年。我們的非公認會計準則利潤率預計全年也會（技術難度），與收入軌跡以及我們啟動的優化計劃的改進保持一致。

With that, this concludes my review of Teva's results for the fourth quarter and fiscal year of 2023. And now I will hand it back to Richard for a summary.

至此，我對 Teva 第四季和 2023 財年業績的回顧就結束了。現在我將把它交還給理查德進行總結。

Thank you, Eli. If you go to the next slide, yes, I would like to just reiterate the financial targets for 2027. Revenue growth mid-single digit, operating margin of 30%, net debt adjusted EBITDA 2x and cash earnings ratio of 80% and reconfirming these as we move forward as we gain confidence on the Pivot to Growth strategy.

謝謝你，伊萊。如果你看下一張投影片，是的，我想重申2027 年的財務目標。營收成長為中個位數，營業利潤率為30%，淨債務調整後EBITDA 為2 倍，現金收益率為80 %，並再次確認這些目標隨著我們對「以成長為中心」的策略充滿信心，我們不斷前進。

Moving on to the final slide. Just to reiterate on the Pivot to Growth strategy will do it to drive growth. Aim was to accelerate growth -- to return to growth in '23 to '24 to accelerate it in '25 to '27. We believe this will be built on the momentum that Eric has in the pipeline and those products coming to the market. And also, you'll start to see the biosimilars gain traction as well based on my earlier comments. So it's clear to see that we're gaining momentum with Pivot to Growth. And now it's about executing as we did in '23 and '24.

繼續看最後一張投影片。只要重申「以成長為中心」策略就足以推動成長。目標是加速成長——在 23 至 24 年恢復成長，並在 25 至 27 年加速成長。我們相信這將建立在埃里克正在開發的勢頭以及即將上市的產品的基礎上。而且，根據我之前的評論，您將開始看到生物相似藥也受到關注。因此，很明顯我們正在透過「轉向成長」獲得動力。現在我們要像 23 年和 24 年那樣執行。

With that, I'll hand it over to the operator to take some questions. Thank you for your attention.

這樣，我會將其交給接線員回答一些問題。感謝您的關注。

(Operator Instructions)

（操作員說明）

Our first question for today comes from Glen Santangelo from Jefferies.

我們今天的第一個問題來自 Jefferies 的 Glen Santangelo。

I just wanted to follow up on the guidance because there's a couple of things that are sticking out to me. It looks like you're assuming at the midpoint, revenues are going to be up a little bit less than 1%, but you're assuming EBITDA at the midpoint is down almost 2%.

我只是想跟進指導，因為有幾件事對我來說很突出。看起來您假設在中點，營收將成長略低於 1%，但您假設 EBITDA 在中點下降近 2%。

And I think if I heard Richard correctly, you're assuming gross margin is going to be up perhaps due to product mix. And so it seems like you're forecasting a much bigger ramp in operating expenses, and I could -- wonder if you could just sort of flesh that out a little bit if it's coming more in the sales and marketing side or greater R&D spend. And then I maybe have just a quick follow-up.

我想，如果理查德沒聽錯的話，你會認為毛利率可能會因為產品組合而上升。因此，您似乎預測營運費用將大幅增加，我想知道您是否可以稍微具體化一下，如果它更多地出現在銷售和行銷方面或增加研發支出。然後我可能會進行快速跟進。

Eli, I think the question is directed to you.

Eli，我想這個問題是針對你的。

Thanks, Glen, for the question. And so first of all, we are looking on the midpoint, which is $16 million compared to the numbers we end up '23, excluding the upfront payment, which means we are looking on 4.3% growth on the midpoint on the top line. And as far as related to some dynamics to the operating margin, we see ourselves keep growing the OpEx. I mentioned that we are working on the range between 27% to 27.5%.

謝謝格倫提出的問題。首先，我們關注的是中點，與 23 年的最終數字相比，該數字為 1,600 萬美元，不包括預付款，這意味著我們預計營收中點將成長 4.3%。就營運利潤率的一些動態而言，我們認為我們的營運支出不斷增長。我提到我們正在研究 27% 到 27.5% 之間的範圍。

And that means that R&D between 6% to 6.5%, stabilization around 6.2% in G&A and sales marketing was around 14.5%. And that means that part of our growth will enable us to keep investing in the business. So for your question, when we line up our guidance, we look on our 2023 excluding the upfront payment.

這意味著研發在 6% 到 6.5% 之間，一般管理費用穩定在 6.2% 左右，銷售行銷在 14.5% 左右。這意味著我們的部分成長將使我們能夠繼續投資於業務。因此，對於你的問題，當我們整理指導意見時，我們會考慮 2023 年的情況，不包括預付款。

Okay. Maybe if I could just sort of follow-up because I just want to make sure I understand the revenue guidance a little bit, and you gave us a lot of the pieces which is helpful. I just want to be clear about what you're seeing in terms of the Generics business in 2024. I mean I could see you obviously cut the COPAXONE assumption a fair amount, but I'm trying to figure out where the rest of the offset is, and I know you have a bunch of big launches on the Generic side, Korlym, teriparatide, Forteo. Can you just sort of flesh out a little bit what you're expecting in that Generics business, just so we're clear on what you're seeing?

好的。也許我可以跟進一下，因為我只是想確保我對收入指導有一點了解，而且你給了我們很多有用的信息。我只是想弄清楚您對 2024 年仿製藥業務的看法。我的意思是，我可以看到您顯然大幅削減了 COPAXONE 假設，但我正在努力弄清楚其餘的抵消額在哪裡是的，我知道你們在仿製藥方面推出了一系列重大產品，如Korlym、特立帕肽、Forteo。您能否具體說明一下您對仿製藥業務的期望，以便我們清楚您所看到的情況？

Glen, it's Richard here. Thanks for the question. Yes. So once again, just to sort of reiterate, and I think your question is directed to the North America Generics business. But just to highlight the fact that our European and international market business, we expect to continue growing well in line with what we did in '23. But to come back to your question about '24 yet, we do have a number of launches that are coming through. We're pleased that we made progress on those.

格倫，我是理查德。謝謝你的提問。是的。再次重申一下，我認為你的問題是針對北美仿製藥業務的。但只是為了強調一個事實，我們的歐洲和國際市場業務，我們預計將繼續與 23 年的情況保持良好成長。但回到你關於 '24 的問題，我們確實有許多產品即將推出。我們很高興我們在這些方面取得了進展。

I would like to highlight that some of those are coming in with competition as well, which you need to take into account when forecasting. And obviously, when we launch products, part of the aim there is to offset some of the price degradation that we see every year in the U.S. And so net-net, we see a stabilization of our North American business going forward. And as we continue to build and improve in our launches and our supply chain, that's why we believe in the medium to long term, we can drive the business back to growth.

我想強調的是，其中一些也會帶來競爭，您在預測時需要考慮到這一點。顯然，當我們推出產品時，部分目標是抵消我們每年在美國看到的價格下降。因此，我們看到我們的北美業務未來將趨於穩定。隨著我們不斷建立和改進我們的產品和供應鏈，這就是為什麼我們相信從中長期來看，我們可以推動業務恢復成長。

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。

So just to clarify on 2024 guidance, including the partnership accounting here from Sanofi upfront. For 2024, is there any specific amount that you're expecting to receive? I believe the next set of milestones is on Phase III initiation, which I believe it wouldn't happen this year. That's the first one.

因此，我想澄清一下 2024 年的指導，包括賽諾菲預先提供的合作夥伴會計。對於 2024 年，您預計會收到什麼具體金額嗎？我相信下一組里程碑是第三階段的啟動，我相信今年不會發生。這是第一個。

And then secondly, I was just curious like on the North America Generics, I mean, the 4Q print seems like a step down from where the franchise has been run rating at, is that because there wasn't any kind of a benefit from Generic Revlimid? Or are we starting to see any change to the price stabilization narrative?

其次，我只是很好奇，就像北美仿製藥一樣，我的意思是，4Q 印刷似乎比特許經營的評級下降了一步，因為仿製藥沒有任何好處來那度胺？或者我們開始看到價格穩定的敘述發生任何變化？

Ash, thanks for those questions. I'll tackle them. So with regard to Sanofi, correct, there is no -- we will not receive any payments in '24. In '25, based on, as Eric highlighted, on a successful interim analysis this year of our Phase II data TL1-A, we'll move into Phase III in '25, and that will trigger some milestones from Sanofi. But in '24, there won't be anything.

阿什，謝謝你提出這些問題。我來對付他們。因此，關於賽諾菲，正確的是，我們不會在 24 年收到任何付款。正如艾瑞克所強調的，在 25 年，基於今年對我們的第二階段數據 TL1-A 的成功中期分析，我們將在 25 年進入第三階段，這將觸發賽諾菲的一些里程碑。但到了24年，就什麼都沒有了。

To go to your North America Generics question, a couple of things and I'll try and answer all of your questions there. Part of, I think, what you saw was the fact that we don't really have any significant revenue of Revlimid in quarter 4. So that's worth noting. And then if you think about the business, we do have -- we have included in TRUXIMA, which is our biosimilar business, which, as you know, has performed well and generated good revenue over a number of years, but obviously, it's declining steadily now.

關於您的北美仿製藥問題，我會盡力回答您的所有問題。我認為，您所看到的部分原因是我們在第四季度並沒有真正獲得 Revlimid 的任何可觀收入。所以這是值得注意的。然後，如果你考慮業務，我們確實有 - 我們已經將其納入 TRUXIMA，這是我們的生物仿製藥業務，正如你所知，多年來表現良好並產生了良好的收入，但顯然，它正在下降現在穩定。

So if you factor those things -- those factors in, then I think my comment about we see a stabilization of the North America Generics business going forward, I think it stands true. Based on the number of launches we have coming out, I think we have the ability to offset a significant amount of the price erosion that we see early in the U.S. And so I think the way to think about it is the stabilization. But on that quarterly change, it's really primarily driven by a bit of the portfolio and a bit of relation to our biosimilar single product TRUXIMA. So hopefully that helps, Ash.

因此，如果你考慮這些因素，那麼我認為我關於我們看到北美仿製藥業務未來穩定的評論是正確的。根據我們發布的產品數量，我認為我們有能力抵消美國早期看到的大量價格侵蝕，因此我認為考慮這個問題的方法是穩定。但就季度變化而言，它實際上主要是由一些產品組合以及與我們的生物仿製藥單一產品 TRUXIMA 的一些關係所驅動的。希望這會有所幫助，阿什。

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。

My question is on the biosimilars. I'm wondering if you think you could potentially make hay with this biosimilar HUMIRA, if you get the interchangeability designation with the February approval, can you leverage that to get like a big chunky contract as a preferred biosimilar supplier? I know that the other noninterchangeable high concentrates have struggled to get share.

我的問題是關於生物相似藥。我想知道您是否認為您有可能利用這種生物仿製藥HUMIRA 獲利，如果您在2 月份獲得批准並獲得可互換性指定，您是否可以利用它作為首選生物仿製藥供應商獲得一份大合約?我知道其他不可互換的高濃縮物一直在努力爭取市場份額。

And then how that maybe carries over into 2025, right? I mean there's a question about Stelara and is the PBM biosimilar space sort of broken with innovators playing the rebating game. Or could you leverage like a portfolio play with like an interchangeable HUMIRA, and then layering on top of that, Stelara? So just kind of wondering your overall perspective on what you've observed at the PBM biosimilars and whether you think that there's an opportunity there.

那麼這種情況可能會持續到 2025 年，對嗎？我的意思是，有一個關於 Stelara 的問題，PBM 生物相似藥領域是否因創新者玩回扣遊戲而被打破。或者你可以像投資組合一樣利用可互換的 HUMIRA，然後在其之上分層，Stelara？因此，我想知道您對 PBM 生物仿製藥觀察到的情況的整體看法，以及您是否認為那裡有機會。

Yes. Thanks, Jason. Thanks for the question. So on the biosimilar one, starting with biosimilar HUMIRA, it really obviously depends on the FDA, given a successful inspection of our partner Alvotech facility in Iceland. Now if that does happen, and we'll hopefully know relatively soon, then it does give us an opportunity to launch. I think there's obviously a lot to play for there still because 2023 was a slope with regard to penetration of the biosimilars. That said, there are a lot of uncertain variables.

是的。謝謝，傑森。謝謝你的提問。因此，在生物相似藥方面，從生物相似藥 HUMIRA 開始，鑑於我們對冰島合作夥伴 Alvotech 工廠的成功檢查，這顯然取決於 FDA。現在，如果這種情況確實發生了，我們希望很快就會知道，那麼它確實給了我們一個推出的機會。我認為顯然還有很多工作要做，因為 2023 年是生物相似藥滲透率的一個斜坡。也就是說，存在著許多不確定的變數。

Will we get the FDA approval of the site and then be able to launch it and then the timing of that launch. And to your point, how we can penetrate with the PBMs. What I would say is we're having good conversations. People are very interested in hearing about when our product can come to the market. I think a lot of that is based on the product profile, not just the interchangeability, the auto-injector. So I see opportunity here.

我們能否獲得 FDA 對該網站的批准，然後能夠啟動它，然後啟動網站的時間。就您而言，我們如何滲透 PBM。我想說的是我們正在進行良好的對話。人們非常有興趣了解我們的產品何時上市。我認為這很大程度上取決於產品簡介，而不僅僅是可互換性和自動注射器。所以我在這裡看到了機會。

The way I've always characterized it is its opportunity over short, medium and long term. I think HUMIRA could add revenue to our business this year. I think it definitely will in '25, '26 and '27. I think the direction of travel will be very clear for biosimilars. I think HUMIRA doesn't define in '23, what happens going forward. So that's why I think about HUMIRA, but we have some (inaudible) there with regard to when we actually get this product approved. I think to talk about Stelara, I think that what I've learned in biosimilars and I've been here quite a long time is 1 product doesn't set the precedent for the next one. And I think Stelara is many things that are different around it.

我一直將其描述為短期、中期和長期的機會。我認為 HUMIRA 可以增加我們今年的業務收入。我認為 25 年、26 年和 27 年肯定會發生。我認為生物相似藥的發展方向將非常明確。我認為 HUMIRA 並沒有定義 23 年未來會發生什麼。這就是我考慮 HUMIRA 的原因，但我們有一些（聽不清楚）關於我們何時真正獲得該產品批准的資訊。我想談談 Stelara，我認為我在生物仿製藥領域學到的東西以及我在這裡工作了很長時間的經驗是，一種產品不會為下一種產品樹立先例。我認為 Stelara 周圍有很多不同的東西。

One, that it has a lot less competitors, for one. And two, we have a clear line of sight of when we're going to be approved, which is -- or we launched which is in February of 2025. So we're very optimistic about that. We see that as a sizable asset. And so we see that as something that can generate significant revenue. Once again, with regard to the speed of uptake, we'll have to see how that plays out. I think the important thing for Teva is we're not being very -- we're not hanging on the fact that these products need to come to market and deliver quick revenues because we have a portfolio at play. We have 13 assets to bring to the market.

第一，它的競爭對手要少得多。第二，我們對何時獲得批准有一個清晰的預期，即我們在 2025 年 2 月推出。所以我們對此非常樂觀。我們認為這是一筆巨大的資產。因此，我們認為這可以產生可觀的收入。再一次，關於吸收速度，我們必須看看效果如何。我認為對 Teva 來說重要的是，我們並沒有堅持這樣一個事實：這些產品需要進入市場並提供快速收入，因為我們有一個產品組合在發揮作用。我們有 13 項資產要推向市場。

As I mentioned, we've got 5 that we're going to launch by 2027. I think they'll all generate a good return and drive our top line and bottom line. But to be very specific about which ones will generate which revenue and when, I think is we don't want to do because of the unpredictability that we've seen in the last year. So I hope with that, there's some way to answer your question, Jason.

正如我所提到的，我們將在 2027 年之前推出 5 個項目。我認為它們都會產生良好的回報並推動我們的營收和利潤。但要非常具體地說明哪些將產生哪些收入以及何時產生，我認為我們不想這樣做，因為我們在去年看到了不可預測性。所以我希望能有辦法回答你的問題，傑森。

Our next question comes from Umer Raffat of Evercore.

我們的下一個問題來自 Evercore 的 Umer Raffat。

A couple here, if I may. First, maybe just on the design of your UC Crohn's study at baseline. Are you expecting mild to moderate or moderate-to-severe patients? And what percentage maybe biologics experienced in your expectations? Secondly, I noticed for your Crohn's study, the endpoint you're using, which is endoscopic response is actually different than what FDA wants for their co-primary. There's a couple of your secondary endpoints on CDAI less than 150 or endoscopic remission, which is what FDA is very focused on for co-primary.

如果可以的話，這裡有一對。首先，也許只是關於加州大學克羅恩分校基線研究的設計。您期待的是輕度至中度還是中度至重度患者？生物製劑在您的預期中所佔的百分比是多少？其次，我注意到，對於您的克羅恩病研究，您使用的終點（內視鏡反應）實際上與 FDA 想要的共同主要終點不同。 CDAI 有幾個次要終點低於 150 或內視鏡緩解，這是 FDA 非常關注的聯合主要終點。

So should we really be focused on those secondary endpoints as the primary basis of determining how the Crohn's trial looked? And then finally if you could just give a quick update on your recent generic launch of Korlym given all the interest and how the launch is going to date?

那麼，我們真的應該把重點放在這些次要終點上，作為確定克隆氏症試驗的主要基礎嗎？最後，考慮到大家的興趣，您是否可以快速介紹一下您最近推出的 Korlym 通用版的最新情況以及該版的發布進度如何？

Thank you, Umer. Richard, I'll take those questions, if you don't mind. So with regard to the inclusion criteria for our study, we're focused on the mild-to-moderate patients that we see coming into the study right now. That's typical of the studies that have been run recently. We're happy to see that our inclusion criteria in the study has been able to enroll well. In fact, our inclusion criteria and our study execution has got an accelerated pace of not only the Ulcerative Colitis, but actually the Crohn's patients as well, which is very encouraging to see because this is one of the first well-controlled, placebo-controlled study for Crohn's in this new MOA.

謝謝你，烏梅爾。理查德，如果你不介意的話，我會回答這些問題。因此，關於我們研究的納入標準，我們將重點放在目前納入研究的輕度至中度患者。這是最近進行的研究的典型情況。我們很高興看到我們的研究納入標準能夠很好地入組。事實上，我們的納入標準和我們的研究執行不僅加快了潰瘍性結腸炎的步伐，而且實際上還加快了克羅恩病患者的步伐，這是非常令人鼓舞的，因為這是第一個控制良好、安慰劑對照的研究之一在這個新的 MOA 中研究克羅恩病。

So the criteria is focused on those patients coming into the study right now. With regard to the endpoint, so the endpoints that we've included in the study are the FDA-accepted study endpoints that we discussed with FDA. They're pretty common across the different studies. I think one of the criteria that you have to pay attention to is how you count some of the clinical endpoints that might change how you see your placebo response compared to your active. So we're confident in the way we've designed the study. We've done this in conjunction with FDA. And then your final question on Korlym, I know that -- Richard, do you want to take that?

因此，標準主要針對那些現在進入研究的患者。關於終點，我們在研究中納入的終點是我們與 FDA 討論過的 FDA 接受的研究終點。它們在不同的研究中非常常見。我認為您必須注意的標準之一是如何計算一些臨床終點，這些終點可能會改變您對安慰劑反應與活性藥物反應的看法。因此，我們對設計研究的方式充滿信心。我們與 FDA 合作完成了這項工作。然後你關於 Korlym 的最後一個問題，我知道——理查德，你想接受這個嗎？

I can take that. Thanks for the question, Umer. So we have launched -- commenced -- we launched that, I think, a week ago. So that is launched in the market. And so I think that answers your question.

我可以接受。謝謝你的提問，烏默。所以我們已經啟動了——開始了——我想，我們是在一周前啟動的。於是就在市場上推出了。所以我認為這回答了你的問題。

Our next question comes from David Amsellem of Piper Sandler.

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

So 1 question on AUSTEDO and 1 on UZEDY. So on AUSTEDO, I wanted to get a sense for the level of sales and marketing investment and DTC investment that you're thinking about the product longer term. Certainly, your competitor has spent pretty heavily promoting and supporting Ingrezza. So how do you think about that? And how does that tie into your long-term thinking regarding the trajectory of operating margins? So that's the number one.

1 個關於 AUSTEDO 的問題和 1 個關於 UZEDY 的問題。因此，在 AUSTEDO 上，我想了解您對產品的長期考慮的銷售和行銷投資以及 DTC 投資的程度。當然，您的競爭對手花費了大量資金來推廣和支持 Ingrezza。那麼您對此有何看法？這與您對營業利潤軌跡的長期思考有何關聯？所以這是第一。

The number two on UZEDY, I think you mentioned the $80 million for '24. Just wanted to drill down on where these patients are coming from. Are these patients that are switching from other LAIs? Are they naive to LAIs? Are you getting switches from, say, Invega, one of the Invega products. Just wanted to get a sense for where your business on UZEDY is coming from in these early days.

UZEDY 上的第二名，我想你提到了 24 年的 8000 萬美元。只是想深入了解這些患者來自哪裡。這些患者是從其他 LAI 轉過來的嗎？他們對 LAI 很幼稚嗎？您是否從 Invega 獲得開關，Invega 產品之一。只是想了解一下您在 UZEDY 上的業務早期的來源。

Thanks, David. Thanks for the question. So on study, you're right, we have invested significantly from AUSTEDO. We have built capabilities. So it's not just about sales force is about bringing in pharmaceutical expertise. And so we've done that, and that, I think, has been a significant contributors to the acceleration of the product and continued performance.

謝謝，大衛。謝謝你的提問。所以在研究方面，你是對的，我們從 AUSTEDO 進行了大量投資。我們已經建立了能力。因此，這不僅是銷售人員的問題，還在於引進製藥專業知識。所以我們已經做到了這一點，我認為，這對產品的加速和持續性能做出了重要貢獻。

We aim to make sure that we are competitive in maximizing the revenue of AUSTEDO. But also knowing that to your last part of your question, we want to be driving improvement in our operating margin. And we see the ability to do that definitively with AUSTEDO and the sales and marketing we've put into it. So as we talk about the $2.5 billion in 2027, this is going to be a major contributor to us driving up our top line, but particularly (inaudible). So we have modeled that out extensively.

我們的目標是確保我們在最大化 AUSTEDO 收入方面具有競爭力。但也要知道，對於您問題的最後一部分，我們希望推動營業利潤率的提高。我們看到 AUSTEDO 以及我們投入的銷售和行銷確實有能力做到這一點。因此，當我們談論 2027 年的 25 億美元時，這將成為我們提高營收的主要貢獻者，但尤其如此（聽不清楚）。所以我們對此進行了廣泛的建模。

With regard to UZEDY, so what we're seeing right now -- and to highlight this is relatively small data, but we're seeing a considerable amount of patients coming from all risperidone. So it's -- a lot of patients are going straight from the oral to our long-acting UZEDY. But when it comes to choosing a long-acting risperidone, a significant proportion of those are going on to UZEDY as well.

關於 UZEDY，我們現在看到的情況是——要強調的是，這是相對較小的數據，但我們看到相當多的患者來自所有利培酮。所以，很多病人直接從口服藥物轉向我們的長效 UZEDY。但在選擇長效利培酮時，很大一部分人也會選擇 UZEDY。

So I think that just highlights, I think, what Eric pointed out, how much the physicians like this product profile, primarily the fact that you can get on to therapeutic levels within 6 to 24 hours, which when you having a schizophrenic episode is really critical. So I think that's why we're seeing that enthusiasm. '24 is about taking that enthusiasm and the access and converting it into scripts. So that's what we're doing. So hopefully, that answers your question, David.

所以我認為這只是強調了艾瑞克所指出的，醫生有多喜歡這個產品簡介，主要是你可以在6 到24 小時內達到治療水平，當你患有精神分裂症發作時，這確實是一個事實。批判的。所以我認為這就是我們看到這種熱情的原因。 '24 就是將這種熱情和訪問權限轉化為腳本。這就是我們正在做的事情。希望這能回答你的問題，大衛。

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 just following up on that OpEx comment. You've obviously stepped up OpEx. You're seeing really nice growth in these core drivers. Your pipeline is progressing. I'm just trying to get my hands around OpEx beyond 2024. So I guess, is this kind of 27% to 27.5% range that we're seeing this year, a good level for the next few years? Or are you now actually reaching an absolute spend level where we can maybe think about some OpEx leverage kind of looking beyond '24?

只要問我 2 個問題。也許只是跟進 OpEx 評論。您顯然已經提高了營運支出。您會看到這些核心驅動因素的成長非常好。您的管道正在取得進展。我只是想了解 2024 年之後的營運支出。所以我想，我們今年看到的 27% 到 27.5% 的範圍是否是未來幾年的良好水平？或者您現在確實達到了絕對支出水平，我們可以考慮一些超越 24 世紀的營運支出槓桿？

And then my second question was just a little bit more color on the international Generic growth drivers. It seemed like that business was particularly strong in '23. I think from your comments, you're assuming similar growth this year. And if you could just give a little bit more color on the dynamics you're seeing in those markets.

然後我的第二個問題是對國際通用成長動力的更多描述。 23 年的業務似乎特別強勁。我認為從您的評論來看，您預計今年會有類似的成長。如果您能為您在這些市場中看到的動態提供更多的色彩。

Okay. Thanks for the questions, Chris. The first one, I'll tag team a bit with Eli. I think just to give you sort of a high level on the OpEx, one of the things we realized here at Teva, we have a significant opportunity in front of us here and now with our innovative portfolio on the market, UZEDY, AUSTEDO and AJOVY and a great pipeline that Eric just talked about. And it's really important we invest in those to optimize them and bring them to the market as soon as possible. So that's what we're doing.

好的。謝謝你的提問，克里斯。第一個，我將用 Eli 來標記球隊。我認為，為了給您帶來高水準的營運支出，這是我們在 Teva 實現的目標之一，我們現在在市場上擁有一個重要的機會，包括 UZEDY、AUSTEDO 和 AJOVY 等創新產品組合以及艾瑞克剛才談到的一個很棒的管道。我們對這些進行投資以優化它們並儘快將它們推向市場非常重要。這就是我們正在做的事情。

Now we absolutely commit and believe we're going to hit our 30% margin in 2027. And investee now allows us to change the trajectory of those products, the speed that we bring them to the market, olanzapine potentially the end of '25, early '26, and that obviously changed, once again, not only our portfolio mix, but the gross margin that they deliver, which obviously falls down to [OP]. So we have thought this through very carefully about that and how we invest and then when we actually start to see some significant pickup in our bottom line. But I'll maybe give the specifics to Eli as well.

現在我們絕對承諾並相信我們將在 2027 年達到 30% 的利潤率。投資對象現在允許我們改變這些產品的發展軌跡，改變我們將它們推向市場的速度，奧氮平可能會在 25 年底， 26年初，這顯然又改變了，不僅是我們的投資組合組合，還有他們提供的毛利率，顯然下降到了[OP]。因此，我們非常仔細地思考了這一點以及我們的投資方式，然後當我們真正開始看到我們的利潤出現一些顯著回升時。但我也許也會向 Eli 提供具體細節。

Thanks, Richard, and thanks, Chris, for the question. Just to continue Richard's answer. And in terms of absolute numbers, we don't see that one too much expand dollar-wise, more than what we have in '24 to '25 onwards. And as we grow with revenue, of course, the percentage will go down. But currently for this year, that's the range, we also would like to remind that there are certain elements in our R&D and in our sales and marketing that's still considered a viable element that we had some level of control in terms of prioritization and timing on this level. So this is been controllable items from our perspective.

謝謝理查德，也謝謝克里斯提出的問題。只是為了繼續理查德的回答。就絕對數字而言，我們並沒有看到美元方面的擴張太多，超過了 24 至 25 年以來的情況。當然，隨著我們收入的成長，這個百分比將會下降。但就今年而言，這就是範圍，我們還想提醒大家，我們的研發以及銷售和行銷中的某些要素仍然被認為是可行的要素，我們在優先事項和時間安排方面擁有一定程度的控制權。這個等級。所以從我們的角度來看，這是一個可控的項目。

And then on the second question you asked, Chris, around the international, pleased to see you've seen a good growth there. And in 2023 and the continued ambitions for 2024, that's primarily driven by prioritization, continued market expansion, but really making sure we focus on the markets that can deliver and our team have done a tremendous job in doing that. And so we're making sure the prioritization of our resources goes to the markets and drive top line and also bottom line, which is a subcomponent of our Pivot to Growth strategy. So hoping that answers both your questions, Chris, and thank you for them.

關於你問的第二個問題，克里斯，在國際比賽中，很高興看到你在那裡看到了良好的成長。 2023 年和 2024 年的持續雄心主要是由優先順序、持續的市場擴張推動的，但要真正確保我們專注於能夠實現目標的市場，我們的團隊在這方面做了巨大的工作。因此，我們確保我們的資源優先投入市場，並推動營收和利潤，這是我們以成長為中心策略的一個組成部分。所以希望這能回答你的問題，克里斯，並感謝你。

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。

Thank you for the questions. So a couple -- just firstly, on the both your Q4 performance and 2024 outlook, which is pretty strong, midpoint higher than the highest Bloomberg estimate I see. It looks like this has been drowned in the aftermath of the restatement, going with a stock reaction. So can you please provide more color on how this happened and the implications for this after this onetime risk statement?

謝謝你的提問。首先，關於你們第四季的表現和 2024 年的前景，這都相當強勁，比我看到的彭博社的最高估計要高。看起來這已經被重述後的影響所淹沒，並伴隨著股票的反應。那麼，在一次性風險聲明之後，您能否提供更多關於這是如何發生的以及對此的影響的資訊？

Secondly, on your partnership with Alvo, considering that Teva has had a greater involvement in the biosimilar facility inspection? Looking at the FDA letter that Alvotech has received, the 483 is related to FDA observing frequent sanitation of operators. So help us understand how easy or difficult to address this issue? And in general, what is the normal resolution which the FDA can accept for such observations?

其次，關於您與 Alvo 的合作關係，考慮到 Teva 更多地參與了生物相似藥設施檢查？查看 Alvotech 收到的 FDA 信函，483 與 FDA 經常觀察操作人員的衛生情況有關。那麼請幫助我們了解解決這個問題有多容易或多困難？一般來說，FDA 對於此類觀察結果可以接受的正常解析度是多少？

Balaji, appreciate the questions. So I'll start with the second question, and then I'll hand the first question over to Eli. So with regard to the Alvotech partnership, correct. We have been heavily involved in helping them. I think I've said in the past, I think we have around about 30 FDA inspections a year across our 54 sites. So we're very proficient at dealing with this, and we've given that guidance and help to Alvotech. I think with regard to the observations that you've seen, the 1 observation, I think it's -- for us, that is considered a relatively small observation.

巴拉吉，謝謝你的提問。所以我將從第二個問題開始，然後我將第一個問題交給 Eli。因此，關於 Alvotech 的合作夥伴關係，正確。我們一直積極參與幫助他們。我想我過去說過，我們每年在 54 個地點進行大約 30 次 FDA 檢查。所以我們非常擅長處理這個問題，我們為 Alvotech 提供了指導和幫助。我認為關於你所看到的觀察結果，第一個觀察結果，我認為對我們來說，這被認為是一個相對較小的觀察結果。

What I caution is with the FDA, it's entirely up to them to give their view on whether that allows us -- or allows Alvotech to have that site cleared, but we think that is a good inspection, which shows the huge amount of work that's been done at that site to make it approvable by the FDA. But I was cautioned the FDA has to approve the site first. And so what I'd say, I think Alvotech had put themselves in a very good position, but we'll have to see how that plays out.

我要提醒 FDA 的是，這完全取決於他們是否允許我們或允許 Alvotech 清理該網站，但我們認為這是一次很好的檢查，這表明需要做大量的工作。已在該地點完成，以使其獲得FDA 的批准。但有人警告我，FDA 必須先批准網站。所以我想說的是，我認為 Alvotech 已經將自己置於非常有利的位置，但我們必須看看結果如何。

And then to answer the first question, I'll hand it back to Eli.

然後，為了回答第一個問題，我將把它交還給 Eli。

Thanks, Balaji, for the question. Yes. So as part of our preparation for the consolidation statement for '23 and we determined that there were errors in a single contingent consideration liability and related expenses, which connected to the estimated future of royalty payments. Those errors resulted from exclusions of some payments related to the royalties. And in that way, the fair value and the [remanagement] we need to recalculate.

謝謝巴拉吉提出的問題。是的。因此，作為我們準備 23 年合併報表的一部分，我們確定單一或有對價負債和相關費用存在錯誤，這與預期未來的特許權使用費支付有關。這些錯誤是由於排除了一些與特許權使用費相關的付款而造成的。這樣一來，我們就需要重新計算公允價值和[重新管理]。

We set the materiality of those errors and determined that those errors are not material to each one of those periods, '22 and '23. And about this revision of the numbers, which is not restatement, and we actually implement them in those financials. I would like to mention that those errors did not impact at all our non-GAAP results as well as notable results. Our total cash flow from operating activities from financing activities, investing activities. As we speak, we are in progress and a process to implement remediation plan to address this internal control.

我們設定了這些錯誤的重要性，並確定這些錯誤對於「22」和「23」期間的每個時期都不重要。關於數字的修訂，這不是重述，我們實際上在這些財務數據中實施了它們。我想指出的是，這些錯誤並沒有影響我們所有的非 GAAP 業績以及顯著業績。我們經營活動產生的現金流量總額來自融資活動、投資活動。正如我們所說，我們正在進行實施糾正計劃以解決此內部控制問題的過程。

Our next question comes from Nathan Rich of Goldman Sachs.

我們的下一個問題來自高盛的內森·里奇。

Great. I wanted to follow up on the North American Generics business. I think, Richard, in response to an earlier question, you talked about stabilization in the North America Generics business in '24. I guess does that mean we should be annualizing the 4Q revenue run rate? Or is that more of a flat year-over-year relative to 2023 comment?

偉大的。我想跟進北美仿製藥業務。我想，理查德，在回答先前的問題時，您談到了 24 年北美仿製藥業務的穩定。我想這是否意味著我們應該對第四季的營收運行率進行年化？或者說，與 2023 年的評論相比，這是否與去年同期相比更加持平？

And then maybe a longer-term question on pricing. Some of the PBMs have talked about moving to kind of cost-plus-drug reimbursement. Just curious if you would expect that to have any longer-term impact on Generic pricing for the industry?

然後可能是關於定價的長期問題。一些 PBM 已討論轉向成本加藥物報銷。只是好奇您是否期望這會對行業的通用定價產生任何長期影響？

Nathan, thank you for your questions. So I think when it comes to North American. One thing -- what we talk about is, and I think we talked about this early on in the Pivot to Growth. We want to first stabilize the U.S. Generic business, in particular, and then get it back to growth. I think what you see here is with the number of launches we've had that we have an opportunity to do that. Now whether that tips into growth or whether it tips it back into flat stabilization, we have to see how it plays out. And the reason for the hesitation in being absolutely definitive is because of what you talked about around pricing and what the erosion will be next week also -- not next week, next year.

內森，謝謝你的提問。所以我認為說到北美。我們談論的一件事是，我想我們在《轉向成長》的早期就討論過這一點。我們特別希望先穩定美國仿製藥業務，然後使其恢復成長。我認為你在這裡看到的是我們已經有機會做到這一點的發射次數。現在，無論這會促進成長還是會使其恢復穩定，我們必須看看結果如何。之所以猶豫是否絕對明確，是因為您談到了定價以及下週（不是下週，而是明年）的侵蝕。

And also with the number of launches we have, how many competitors come in and how they play out. So there's a lot of variables within that. I think for us, it's about stability and building on that and getting it back to growth and to be, I think, thoughtful about how we communicate that. So that's the way to think about it.

還有我們發布的產品數量、競爭對手的數量以及他們的表現。所以這裡面有很多變數。我認為對我們來說，這是關於穩定並在此基礎上繼續發展並使其恢復增長，並且我認為，要深思熟慮我們如何溝通這一點。這就是思考這個問題的方式。

With regard to pricing and what you said about the PBMs saying that, I welcome anybody that starts to look at Generics pricing to make it sustainable. I think right now, it's a very challenging environment continues to be where the value of the Generics bring to the health care industry, to the hospital, to society is not reflected in the price that we can sell them at. And I think that makes a very challenging environment. And I think probably that has led to the PBMs and the payers thinking about actually supply challenges and how do we mitigate those.

關於定價以及您對 PBM 的看法，我歡迎任何開始研究仿製藥定價以使其可持續的人。我認為現在仍然是一個非常具有挑戰性的環境，仿製藥為醫療保健產業、醫院和社會帶來的價值並沒有反映在我們的銷售價格中。我認為這創造了一個非常具有挑戰性的環境。我認為這可能導致 PBM 和付款人思考實際的供應挑戰以及我們如何緩解這些挑戰。

And I think this is what this has raised this discussion. With this being a solution, I think there's many others I could also suggest. I think ultimately, you have to have a price that creates a sustainability that allows us to invest in not any launches, but in capital in our manufacturing sites. And I think that requires people just to step back and understand a bit more about what it takes to achieve that. So good the fact that it's having a conversation now but I don't think that is the silver bullet necessarily to improve the market. Thanks for the question, Nathan.

我認為這就是引發討論的原因。有了這個解決方案，我想我還可以建議很多其他解決方案。我認為最終，你必須有一個能夠創造永續性的價格，使我們能夠投資於我們生產基地的資本，而不是任何產品的發布。我認為這需要人們退後一步，並更多地了解如何實現這一目標。現在正在進行對話真是太好了，但我認為這不一定是改善市場的靈丹妙藥。謝謝你的提問，內森。

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。

Just curious, can you comment on a margin now that the planned divestiture, I think it was $700 million external, $300 million internal revenues, but just wondering how to think about how profitable that business is and we try to like think about potential valuations? And then with the olanzapine LAI program, will you guys give any updates regarding number of injections without PDSS signal? Or will the next update just be the second half 2024 pivotal top line update?

只是好奇，您能否評論一下計劃中的資產剝離的利潤率，我認為這是7 億美元的外部收入，3 億美元的內部收入，但只是想知道如何考慮該業務的盈利能力，以及我們嘗試考慮潛在的估值？然後，對於奧氮平 LAI 計劃，你們能否提供有關沒有 PDSS 訊號的注射次數的任何更新？或者下一次更新只是 2024 年下半年的關鍵頂線更新？

Thank you, Jason. Thanks for your question coming back. So I think with regard to TAPI, I think the idea is what it's going to do for margins. And I'll hand that to Eli. But on the whole, I think pretty neutral with regard to what it does to margin. So I don't think of it as impacting our margins in a positive or negative way. That's probably the simplest way. So think of that one. Anything to add to that, Eli?

謝謝你，傑森。謝謝你回來提問。所以我認為關於 TAPI，我認為這個想法是為了提高利潤率。我會把它交給伊萊。但總的來說，我認為對於它對保證金的影響相當中性。因此，我不認為這會對我們的利潤率產生正面或負面的影響。這可能是最簡單的方法。所以想想那個。伊萊，還有什麼要補充的嗎？

No. I think it's -- I don't have anything to add.

不，我認為——我沒有什麼要補充的。

Okay. And then going on to olanzapine. I'll hand that one to Eric and maybe get more specific about the fact that we fully recruited the study and maybe how many injections we've had.

好的。然後繼續服用奧氮平。我會把這個交給艾瑞克，也許會更具體地說明我們完全招募了這項研究的事實，以及我們注射了多少次。

So I can give you an updated date on that right now. So there's 675 patients in the study that's fully enrolled globally at this point. To date, we've got 2,030 injections completed, no PDSS at this point. That's 62% of our total target that we want for the proper package for this submission so we're well on our way, and we'll monitor this very closely.

所以我現在可以給你更新的日期。目前，該研究中有 675 名患者已在全球全部入組。到目前為止，我們已完成 2,030 次注射，此時沒有 PDSS。這是我們希望為此次提交提供適當包的總目標的 62%，因此我們進展順利，我們將密切監視這一情況。

Our next question comes from Oleksiy Soroka of ING.

我們的下一個問題來自 ING 的 Oleksiy Soroka。

With regards to your debt, what are your plans for refinancing the upcoming maturities, including the bonds?

關於您的債務，您對即將到期的再融資（包括債券）有何計劃？

Thank you, Oleksiy, for the question. Eli, could you take that one?

謝謝奧萊克西提出的問題。伊萊，你能拿走那個嗎？

Yes. Thanks for the question. Yes. So if we're looking on the coming year, we'll have a maturity of around $950 million due in April and another approximately $700 million due in October on the euro maturities. And we are pretty, I would say, positioned very well to manage the maturities of '24 and '25 from our organic free cash flow. And we will have a tower of around $3.4 billion and around October '26, which allowing us enough time to consider when we will need to make the next refinancing.

是的。謝謝你的提問。是的。因此，如果我們展望來年，我們將有約 9.5 億美元的歐元到期日在 4 月到期，另外約 7 億美元的歐元到期日將在 10 月到期。我想說，我們的定位非常好，可以透過我們的有機自由現金流來管理「24」和「25」的到期日。我們將在 26 年 10 月左右擁有一座價值約 34 億美元的塔樓，這讓我們有足夠的時間考慮何時需要下一次再融資。

We are constantly looking on the market in terms of capacity and trends, and we are calculating our strategy around it. And -- but currently, we don't have, I would say, any specific needs to go early.

我們不斷關注市場的容量和趨勢，並圍繞它計算我們的策略。而且 - 但目前，我想說，我們沒有任何提前出發的具體需求。

But would you expect to deal with this peak that you mentioned in October 2026 this year? Just prefunded it.

但您預計今年能應付您提到的 2026 年 10 月的高峰嗎？剛剛預付了錢。

Yes. So it really depends on the dynamics and the weighted average of, I would say, are maturities that we need to turn down, which is at the level of 3-plus percent, that's maturity in '26 and the market now is in the range of 6% to 7%. So it really depends on how this one evolves because that will need to actually consider some capital allocation in terms of interest expenses and timing. But as I mentioned, we are constantly looking on that one. And usually, we would like to go between 12 to 16 months ahead in order to address those maturities. But we think that there is kind of enough time, but still, we are reviewing all those strategies around it.

是的。因此，這實際上取決於動態和加權平均，我想說的是，我們需要拒絕的到期日，這是 3% 以上的水平，這是 26 年的到期日，現在的市場處於這個範圍內6％至7％。因此，這實際上取決於這個問題如何發展，因為這需要實際考慮利息支出和時間安排的一些資本配置。但正如我所提到的，我們一直在關注這個問題。通常，我們希望提前 12 至 16 個月來解決這些到期問題。但我們認為有足夠的時間，但我們仍在審查圍繞它的所有策略。

Our next question comes from Madison Aron from JPMorgan.

我們的下一個問題來自摩根大通的麥迪遜·阿倫。

On your slide, Page 14, on the Generic pipeline, you include NEXPLANON as one of your technology targets. Can you just walk us through as to what you're planning there? Is that an ANDA filing that you're planning? Just if you could give us some detail?

在您的投影片（第 14 頁）的通用管道上，您將 NEXPLANON 作為您的技術目標之一。您能向我們介紹一下您在那裡的計劃嗎？您正在計劃提交 ANDA 申請嗎？您能給我們一些細節嗎？

Madison, thanks for the question. I'm glad you noticed the Slide 14 and the numerous complex generics where we're bringing to the market. With regard to some of these, obviously, it's quite a competitive environment. So we don't like to go into too much of the specifics because of the nature of that. I think highlighting them gives a good insight into what we have and what's coming. And I think that's what we wanted to show here and the fact that we have a very broad portfolio across a number of technologies. So that's our aim here, but for competitive reasons, we really don't want to get into the strategy and the details around that. And hopefully, you can understand that.

麥迪遜，謝謝你的提問。我很高興您注意到 Slide 14 和我們推向市場的眾多複雜仿製藥。對於其中一些，顯然這是一個競爭相當激烈的環境。因此，由於其性質，我們不喜歡討論太多細節。我認為強調它們可以讓我們更好地了解我們已經擁有的東西和即將發生的事情。我認為這就是我們想要在這裡展示的，以及我們在多種技術上擁有非常廣泛的產品組合的事實。這就是我們的目標，但出於競爭原因，我們真的不想討論戰略和相關細節。希望你能理解這一點。

At this time, we currently have no further questions. So I'll hand back to Richard Francis for any further remarks.

目前，我們沒有進一步的問題。因此，如果有任何進一步的評論，我將轉交給理查德·弗朗西斯。

Thank you. And thank you, everybody, for dialing in, I appreciate your interest in Teva. I appreciate the questions. And I look forward to catching up with many of you in the next couple of days and obviously look forward to speaking to our quarter 1 earnings later in the year. Thank you very much.

謝謝。感謝大家撥通電話，我感謝你們對 Teva 的興趣。我很欣賞這些問題。我期待在接下來的幾天內與你們中的許多人見面，並且顯然期待在今年晚些時候談論我們的第一季收益。非常感謝。

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

感謝您參加今天的電話會議。現在您可以斷開線路。