Teva Pharmaceutical Industries Ltd (TEVA) 2021 Q4 法說會逐字稿

Good day, and thank you for standing by, and welcome to the Teva Fourth Quarter and Full Year 2021 Financial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

美好的一天，感謝您的支持，歡迎參加 Teva 2021 年第四季度和全年財務業績電話會議。 （操作員說明）請注意，今天的會議正在錄製中。 （操作員說明）

I would now like to hand the conference over to your speaker today, [Ron] Mannix, Senior Vice President, Head of Investor Relations. Please go ahead, sir.

我現在想把會議交給你今天的演講者，高級副總裁兼投資者關係主管 [Ron] Mannix。請繼續，先生。

Thank you, Annette. Thank you, everyone, for joining us today to discuss Teva's Fourth Quarter and Fiscal Year 2021 Financial Results. We also have had an opportunity to review our earnings 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.

謝謝你，安妮特。謝謝大家今天加入我們討論梯瓦公司第四季度和 2021 財年的財務業績。我們也有機會回顧了今天上午早些時候發布的收益新聞稿。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展示的幻燈片副本。

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.

請查看我們在幻燈片 #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和我們的 SEC 表格 10-K 和 10-Q。

To begin today's call, Danish Schultz, Teva's CEO, will provide an overview of the 2021 performance, recent events and priorities going forward. Our CFO, Eliyahu Kalif, will follow-up by reviewing the fourth quarter financial results in more detail before providing an overview of Teva's 2022 financial outlook.

為了開始今天的電話會議，梯瓦 (Teva) 首席執行官丹麥舒爾茨 (Danish Schultz) 將概述 2021 年的業績、近期事件和未來的優先事項。我們的首席財務官 Eliyahu Kalif 將在提供梯瓦 2022 年財務前景概述之前更詳細地審查第四季度的財務業績。

Joining Kare and Eli on the call today is Brendan O'Grady, Teva's Head of North America Commercial, and will be available during the question-and-answer session that will follow the presentation.

今天與 Kare 和 Eli 一起參加電話會議的是梯瓦 (Teva) 北美商業負責人 Brendan O'Grady，他將在演講後的問答環節中提供幫助。

Please note that today's call will run approximately 1 hour.

請注意，今天的通話將持續大約 1 小時。

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

有了這個，我現在把電話轉給 Kare。凱爾，如果你願意，好嗎？

Thank you very much, Ron and welcome, everybody, and thank you for your interest in our company. I'll start by commenting on the 2021 highlights. We came in with revenues at $15.9 billion. We did see some headwinds compared to our initial guidance, basically coming from COVID that resulted in less volumes in general in the marketplace of generics and OTC both in Europe and U.S. And we also had a bit of headwind from the fact that the U.S. doctors didn't see as many patients as normally. So we saw a slightly slower penetration of some of our products than we predicted from beginning of the year. But all in all, we are happy with the $15.9 billion that we ended up with as revenues.

非常感謝您，Ron，歡迎大家，感謝您對我們公司的關注。我將首先評論 2021 年的亮點。我們的收入為 159 億美元。與我們最初的指導相比，我們確實看到了一些不利因素，主要來自 COVID，這導致歐洲和美國仿製藥和非處方藥市場的總體銷量減少。而且我們也有一些不利因素，因為美國醫生沒有不像往常那樣看那麼多病人。因此，我們看到我們的一些產品的滲透率比我們從年初開始的預測要慢一些。但總而言之，我們對最終獲得的 159 億美元收入感到滿意。

The adjusted EBITDA came in at USD 4.9 billion, which is very much within the guidance. The GAAP diluted EPS came in at $0.38 and non-GAAP diluted EPS came in at $2.58, again in the middle of our guidance. Free cash flow at $2.2 billion, also within our guidance, and the debt reduction continues, and the net debt is now reduced down to $20.9 billion. So it won't be long before we get below $20 billion, which is nice.

調整後的 EBITDA 為 49 億美元，非常符合指引。 GAAP 攤薄後每股收益為 0.38 美元，非 GAAP 攤薄後每股收益為 2.58 美元，再次處於我們指引的中間。自由現金流為 22 億美元，也在我們的指導範圍內，債務減少仍在繼續，淨債務現在降至 209 億美元。所以用不了多久我們就會低於 200 億美元，這很好。

If we look at the business highlights, then of course, we had to handle the COVID-19 pandemic, which continued. We were hoping at the beginning of the year that it would be over. But as we all know, it wasn't, it continued. And we did see, of course, a lot of challenges, which we overcame operationally. So our whole operations worked out really, really well. I'd like to thank all our employees or franchises fantastic job all throughout the years. Then we did do a refinancing, which I'll comment on. We saw nice growth that was AUSTEDO, nice growth of AJOVY, and we are excited about launching risperidone LAI later this year, and I'll comment on all of those in the following slides.

如果我們看一下業務亮點，那麼當然，我們必須應對持續不斷的 COVID-19 大流行。我們希望在今年年初它會結束。但眾所周知，它不是，它繼續。當然，我們確實看到了很多挑戰，我們在運營上克服了這些挑戰。所以我們的整個操作真的非常非常好。我要感謝我們所有的員工或特許經營商多年來出色的工作。然後我們確實進行了再融資，我將對此發表評論。我們看到了 AUSTEDO 的良好增長，AJOVY 的良好增長，我們很高興在今年晚些時候推出利培酮 LAI，我將在下面的幻燈片中評論所有這些。

So we can go to the next slide, please. The #1 question I always get from analyst investors is, of course, on the litigation side. And as you all know, we have legacy opioid litigation, dating back to somewhere between 2000 and 2010. And there's a lot of this -- more than 3,500 different cases are pending, so to speak. Now we've been making some progress recently.

請看下一張幻燈片。我總是從分析師投資者那裡得到的第一個問題當然是訴訟方面的問題。眾所周知，我們有遺留的阿片類藥物訴訟，可以追溯到 2000 年至 2010 年之間。其中有很多——可以說，有 3,500 多個不同的案件正在審理中。現在我們最近取得了一些進展。

And if I start with the court decisions, then to be very brief about it, we had a court position, which was a bench trial in Orange County, California, where it basically was stated that if you do everything correct and the prescriptions are correct, the products are in compliance with FDA regulations and DAE regulations, and there's no basis for claiming public nuisance liability. So that was a clear win for us.

如果我從法院判決開始，那麼簡單地說，我們有一個法庭職位，這是在加利福尼亞州奧蘭治縣進行的法庭審判，基本上是說，如果你做的一切都是正確的並且處方是正確的，產品均符合FDA法規和DAE法規，並沒有要求承擔公害責任的依據。所以這對我們來說是一個明顯的勝利。

Then J&J had a verdict in the Oklahoma Supreme Court, which was again a clear win again saying that you cannot use public nuisance when you have products that are completely in compliance with all rules and regulations. And then there was a jury trial in New York where we lost, and we were found to be viable. So it was actually the state of New York as well. So that was an interesting verdict. There's a mistrial motion pending due to arguments from the AG at the end of the trial, which were not correct.

然後強生在俄克拉荷馬州最高法院作出裁決，再次明確勝訴，當您擁有完全符合所有規則和法規的產品時，您不能使用公害。然後在紐約進行了陪審團審判，我們輸了，我們被認為是可行的。所以它實際上也是紐約州。所以這是一個有趣的判決。由於審判結束時總檢察長的論點不正確，因此有一項未決動議未決。

So if we then switch to the settlement front, then you all know we had a settlement in Louisiana some time ago, and now we've had a settlement in Texas both these settlements combine a cash compensation and providing new products. In the case of Texas, it's generic Narcan spray. And that's a product you use when you have an overdose situation. So we're very happy about the settlement. We think it's a good way forward. It makes sense for Texas to get some resources to take care people suffering from substance abuse, and it makes sense to get a generic Narcan spray, which can help people in an overdose situation. So I'm always optimistic, as you know. So I'm still optimistic that we can reach a nationwide settlement within the next 12 months. I've said that before. I'm still believing in that. And I think that the Texas settlement will be a good starting point for those ongoing discussions.

因此，如果我們然後切換到和解陣線，那麼你們都知道我們前段時間在路易斯安那州有一個和解，現在我們已經在德克薩斯州有一個和解，這兩個和解結合了現金補償和提供新產品。在德克薩斯州，它是通用的 Narcan 噴霧劑。這是您在服用過量時使用的產品。所以我們對和解感到非常高興。我們認為這是一個很好的前進方向。得克薩斯州獲得一些資源來照顧遭受藥物濫用的人是有意義的，獲得通用的 Narcan 噴霧劑是有意義的，它可以幫助處於過量服用情況的人。所以我總是很樂觀，你知道的。因此，我仍然樂觀地認為，我們可以在未來 12 個月內達成全國性解決方案。我以前說過。我仍然相信這一點。我認為德克薩斯州的和解將是這些正在進行的討論的一個很好的起點。

If we move to the next slide. And here, you can see our revenues throughout the year. And you will see that we had a bigger revenue in Q4 '20 than we had in Q4 '21. And the reason for that is really that we launched TRUVADA and Atripla -- generic TRUVADA and Atripla back in Q4 '20. And we didn't have this similar big launch in Q4 '21. Other than that, you could say it's really a very steady business. And you can see from the different components, Europe, international markets and so on that they are very steady, and performing quite well.

如果我們轉到下一張幻燈片。在這裡，您可以看到我們全年的收入。您會看到我們在 20 年第四季度的收入比在 21 年第四季度的要高。其原因實際上是我們在 20 年第四季度推出了 TRUVADA 和 Atripla——通用 TRUVADA 和 Atripla。而且我們在 21 年第四季度也沒有類似的大型發布。除此之外，您可以說這確實是一項非常穩定的業務。而且你可以從不同的組件，歐洲，國際市場等等看到它們非常穩定，並且表現相當不錯。

If we go to the next slide. So in the U.S. marketplace, we have 2 main growth drivers, and that's AUSTEDO and AJOVY. And let's look at AUSTEDO first. You can basically see that we continue to increase our script count per quarter, basically, more and more people are getting on the therapy. And you can see that we also, on an average basis, continue to increase revenues quarter-by-quarter. It's a little up and down. As you can see, we have some swings here. And that's basically because you see some volatility sometimes with the wholesalers. We did see some, what you call, spec buying in the fourth quarter. That's basically in anticipation of a price increase, which is traditionally taken at the beginning of the year, so early January. Wholesaler sometimes buy product, of course, to avoid the price increase, and we saw a bit of that. But underlying, there's a very strong correlation between the nice growth in scripts and patients and the nice growths in revenue. And we expect revenue, of course, to continue to grow throughout this year. Why can we expect that? Let's look at the next slide, basically, because AUSTEDO is indicated for Huntington's disease, chorea and Huntington's, so involuntary movements in Huntington's, but it's also indicated for Tardive dyskinesia. Tardive dyskinesia are these significant involuntary movements that are socially debilitating, and that can really be a big problem for the patients suffering from it. There is around 500,000 patients or persons in U.S. suffering from Tardive dyskinesia. It's under-diagnosed and it's undertreated. Our estimate is at less than 6% is treated as we speak. And of course, we are working to broaden that base, making sure that the benefit of the product will reach more patients. This will drive increased scripts, and will, of course, also drive increased revenues for sale. So we are also, like I said before, optimistic that we'll see increased patient numbers throughout the current year.

如果我們轉到下一張幻燈片。所以在美國市場，我們有兩個主要的增長動力，那就是 AUSTEDO 和 AJOVY。讓我們先看看AUSTEDO。你基本上可以看到我們每季度繼續增加我們的劇本數量，基本上，越來越多的人正在接受治療。您可以看到，我們平均而言，收入還在逐季增加。它有點上下。如您所見，我們這裡有一些波動。這基本上是因為您有時會看到批發商出現一些波動。我們確實在第四季度看到了一些你所說的規格購買。這基本上是對價格上漲的預期，傳統上是在年初，也就是一月初。批發商有時會購買產品，當然是為了避免價格上漲，我們也看到了一點。但從根本上說，劇本和患者的良好增長與收入的良好增長之間存在很強的相關性。當然，我們預計收入將在今年全年繼續增長。為什麼我們可以期待呢？讓我們看下一張幻燈片，基本上，因為 AUSTEDO 適用於亨廷頓病、舞蹈病和亨廷頓病，所以亨廷頓病的不自主運動，但也適用於遲發性運動障礙。遲發性運動障礙是這些顯著的不自主運動，它們在社會上使人衰弱，這對於患有它的患者來說確實是一個大問題。美國約有 500,000 名患者或個人患有遲發性運動障礙。它的診斷不足，治療不足。在我們說話時，我們的估計是不到 6%。當然，我們正在努力擴大這一基礎，以確保產品的好處將惠及更多患者。這將推動劇本的增加，當然，也會推動銷售收入的增加。因此，正如我之前所說，我們也樂觀地認為，今年我們將看到患者人數增加。

If we move to the next slide, then we are looking at AJOVY. As you know, AJOVY is preventive therapy for migraine. We are competing with 2 other products. We have the longest acting product profile, which basically means that our product can be used both monthly and quarterly, which is, of course, a benefit that flexibility for patients, and the long duration also means that you have a very steady clinical action profile. So good efficacy on the product.

如果我們移到下一張幻燈片，那麼我們正在查看 AJOVY。如您所知，AJOVY 是偏頭痛的預防療法。我們正在與其他 2 種產品競爭。我們的產品作用時間最長，這基本上意味著我們的產品可以每月和每季度使用一次，這對患者來說當然是一個好處，而且持續時間長也意味著你有一個非常穩定的臨床作用曲線.所以對產品有很好的療效。

We continue to grow scripts in the U.S. As you can see, there's a lot of users in the U.S., and we continue also to grow our scripts in EU and also our market share. And here you see that our market share, the last one we have for November, I believe, is now around 28%. And we have changed our ambition. We started out with an ambition some years ago because we launched as #3 of having more than 20% share, then we moved it to 25%. And now we have an ambition of at least having 1/3 of the market both in U.S. and Europe. We also just launched in Japan with our partner, Otsuka, and we are very happy about the performance of AJOVY and confident that the product will keep on increasing revenues in the current year.

我們繼續在美國增加腳本。如您所見，美國有很多用戶，我們也在繼續增加我們在歐盟的腳本以及我們的市場份額。在這裡你可以看到我們的市場份額，我相信我們在 11 月份擁有的最後一個市場份額，現在約為 28%。我們改變了我們的野心。幾年前我們開始有一個雄心壯志，因為我們以擁有超過 20% 的份額的第三名推出，然後我們將其提高到 25%。現在我們的雄心是至少在美國和歐洲擁有 1/3 的市場。我們也剛剛與我們的合作夥伴大塚在日本推出，我們對 AJOVY 的表現感到非常高興，並相信該產品將在本年度繼續增加收入。

If we take a look at our pipeline, then we have a lot of exciting products here. That's a very big biosimilar portfolio, which I'll comment on in just a moment. We have some exciting biopharmaceutical products in development. And then we have the risperidone LAI, which has been filed with FDA, and where we're looking forward to getting an approval, hopefully in the middle of this year.

如果我們看看我們的管道，那麼我們這裡有很多令人興奮的產品。這是一個非常大的生物仿製藥產品組合，我稍後會對此進行評論。我們正在開發一些令人興奮的生物製藥產品。然後我們有利培酮 LAI，它已向 FDA 提交，我們期待獲得批准，希望在今年年中。

And let me just talk a little bit more in detail about risperidone LAI. If we move to the next slide, then risperidone LAI is for patients with schizophrenia. It's an antipsychotic. And in the Phase III trial, it showed phenomenal efficacy. So you see here the risk of relapse was reduced by up to 80% versus placebo. So that's one of the best results you can find for long-acting antipsychotics. So it's a really, really efficacious product. And it's also the easiest product to use. And what do I mean by that? Well, many of the long-acting antipsychotics have what you call intramuscular injection, which means you have a relatively long needle and you need to make a depot in the muscle tissue. That is relatively painful and complicated. So the administration of the products is not that easy. This product, you inject subcutaneous with a very small short needle. It's a low volume of injection, and you can inject in different places. So it's basically an easy way to get your therapy that is as efficacious, if not more efficacious than anything else. So we expect to see a very good launch of this product once we get approval, and we are very much looking forward to this and bringing the benefits to the patients, severe from schizophrenia, who needs stable therapy in order to avoid relapses, which can really hurt their cognitive function capability.

讓我更詳細地談談利培酮 LAI。如果我們轉到下一張幻燈片，那麼利培酮 LAI 是針對精神分裂症患者的。這是一種抗精神病藥。在 III 期試驗中，它顯示出驚人的療效。所以你在這裡看到，與安慰劑相比，復發的風險降低了 80%。所以這是長效抗精神病藥的最佳結果之一。所以它是一個非常非常有效的產品。它也是最容易使用的產品。我的意思是什麼？嗯，許多長效抗精神病藥都有你所說的肌肉注射，這意味著你有一根相對較長的針頭，你需要在肌肉組織中形成一個長效藥庫。這是相對痛苦和復雜的。所以產品的管理並不是那麼容易。這個產品，你用一根非常小的短針皮下注射。它的注射量很小，您可以在不同的地方注射。因此，這基本上是一種讓您的治療與其他任何方法一樣有效的簡單方法，如果不是更有效的話。因此，我們希望一旦獲得批准，該產品會很好地推出，我們非常期待這一點，並為精神分裂症嚴重的患者帶來好處，他們需要穩定的治療以避免復發，這可以確實傷害了他們的認知功能能力。

So let's go to the next slide, where I'll give you just a little heads up on our biosimilar portfolio. So we have 13 biosimilars in development, about half of them are in-house programs, half of them are programs that we have in-licensed. It's a very strong portfolio. Roughly, we are addressing some 80% of the value that goes off patent in the coming years. And we believe we can grab a good share of that value. Of course, there are other competitors. But if you look at TRUXIMA, which was the biosimilar or which is the biosimilar of Rituxan or biosimilar. And right now, we have 28% volume market share, which we think is very good. And it's a nice product for us. It has shown stability in the marketplace also on the pricing. So we're very optimistic about the commercial potential of our biosimiliar portfolio. And it will, of course, also add increased access for populations around the world, just like generic products does, so does biosimilar products ensure access to important medicines worldwide. Also in Europe, we are launching products now, and we'll have a LUCENTIS biosimilar that we launched during this year.

因此，讓我們轉到下一張幻燈片，在這裡我將向您介紹我們的生物仿製藥產品組合。因此，我們有 13 種生物仿製藥正在開發中，其中大約一半是內部項目，其中一半是我們獲得許可的項目。這是一個非常強大的投資組合。粗略地說，我們正在解決未來幾年專利失效的約 80% 的價值。我們相信我們可以從這一價值中分得一杯羹。當然，還有其他競爭對手。但是如果你看一下 TRUXIMA，它是生物仿製藥，或者是 Rituxan 或生物仿製藥的生物仿製藥。現在，我們擁有 28% 的銷量市場份額，我們認為這非常好。這對我們來說是一個很好的產品。它在價格上也顯示出市場穩定性。因此，我們對我們的生物類似物產品組合的商業潛力非常樂觀。當然，它還將增加世界各地人口的可及性，就像仿製藥一樣，生物仿製藥產品也能確保在全球範圍內獲得重要藥物。同樣在歐洲，我們現在正在推出產品，我們將在今年推出 LUCENTIS 生物仿製藥。

Now we've also always been focused on our gross margin and operating margin. And I won't go into all the details here. But what I will tell you is it's not a coincidence when you see our margins improving. It's a lot of work by thousands of people in our organization, in our manufacturing organization, in our procurement organization, basically optimizing all the classical elements of manufacturing. And you see some of the headlines here, procurement, network operational excellence, end-to-end supply chain, agile operations. So these are all the classical things. And if you're interested in manufacturing optimization, you can rest assured that we're doing all the things that you can do. It takes time. It's not something that happens overnight, but we are well underway, and we have hundreds of specific projects that will contribute to a continuation of margin expansion over the coming years. Now one of the very simple ways to explain this is to look at the number of sites.

現在我們也一直關注我們的毛利率和營業利潤率。我不會在這裡詳細介紹所有細節。但我要告訴你的是，當你看到我們的利潤率提高時，這並非巧合。這是我們組織、製造組織、採購組織中成千上萬人的大量工作，基本上優化了製造的所有經典元素。你會在這裡看到一些頭條新聞，採購、網絡卓越運營、端到端供應鏈、敏捷運營。所以這些都是經典的東西。如果您對製造優化感興趣，您可以放心，我們正在做您能做的所有事情。這需要時間。這不是一夜之間發生的事情，但我們正在順利進行，我們有數百個具體項目將有助於未來幾年繼續擴大利潤率。現在，解釋這一點的一種非常簡單的方法是查看站點的數量。

So if you take the next slide. Here, we're showing you how we have been integrating the company since I joined in 2017. You have to remember that Teva as a company is created by more than 20 acquisitions over more than 20 years, and that leaves a very complex footprint of offices, of manufacturing sites, of R&D sites. But it also leaves a lot of capabilities. So the trick here is to keep all your capabilities, keep all your operational strength, but consolidate your site so that you get more efficient, bigger sites, fewer sites. And here, you can see over the last 5 years, how we've gone from 80 manufacturing sites down to around 50. And we have plans to continue this over the next couple of years, we will be divesting or decommissioning, probably around another 10 sites. So this evolution will continue. The same thing will, of course, happen for our office sites and our R&D sites. So continued optimization, more to come in the coming years.

所以如果你拿下一張幻燈片。在這裡，我們向您展示自我 2017 年加入以來，我們是如何整合公司的。您必須記住，Teva 作為一家公司是由 20 多年的 20 多次收購創建的，這留下了非常複雜的足跡辦公室，生產基地，研發基地。但它也留下了很多能力。所以這裡的訣竅是保持你所有的能力，保持你所有的運營實力，但整合你的站點，這樣你就可以獲得更高效、更大的站點，更少的站點。在這裡，你可以看到在過去的 5 年裡，我們如何從 80 個生產基地減少到大約 50 個。我們計劃在接下來的幾年裡繼續這樣做，我們將剝離或退役，可能會在另一個10 個站點。因此，這種演變將繼續下去。當然，我們的辦公場所和研發場所也會發生同樣的事情。所以繼續優化，未來幾年會有更多。

Now if we take in -- look at an example here, our European business, then you will notice here that the operating margin is improving. Now the operating margin basically improves for 2 reasons. One is the gross margin improvements that I just talked about. But the other one is, as you consolidate your commercial offices, as you consolidate your commercial operation and optimize that -- and of course, also, you could say, your commercial costs as a percent of sales also comes down. And those 2 factors have been driving up the operating margin in Europe. You can see here from 25% to 31%, a very, very nice and strong development. And again, something that will continue to improve, mainly now with the contribution from the gross margin because we're getting closer to having optimized the commercial footprint in both Europe, U.S. and international markets.

現在，如果我們考慮——看一個例子，我們的歐洲業務，那麼你會注意到這裡的營業利潤率正在提高。現在營業利潤率基本提高有兩個原因。一是我剛才談到的毛利率改善。但另一個是，當你整合你的商業辦公室時，當你整合你的商業運營並優化它——當然，你也可以說，你的商業成本佔銷售額的百分比也會下降。這兩個因素一直在推高歐洲的營業利潤率。你可以在這裡看到從 25% 到 31%，這是一個非常、非常好的和強大的發展。再說一次，這將繼續改善，主要是現在毛利率的貢獻，因為我們越來越接近優化歐洲、美國和國際市場的商業足跡。

But I've talked a lot about margins, let's just take a look at the operating margin here. You can see here how we had a bad run down from 28.8% (sic) [27.8%] in '17 down to 24.5% in '19. That is really driven by a significant drop in COPAXONE revenues as a consequence of the patent expiry on COPAXONE. Now COPAXONE is now down. As you know, this year, it will be less than $1 billion in revenue. So it's not a major factor in our market anymore. And we've been working hard to improve the gross margin, as I told you, and the operating margin. And we set a target 5 years ago or actually 4 years ago, but for the end of 2023, then it will be a 5-year target from 18% to 23%. And that target is 28%. And as you can see, we are very well on our way to hit that. And I've always said that we won't bring out new targets until we hit our target, but it might just be that we get so close that in the later part of this year, we will actually share with you future targets so that you don't get the wrong impression that we will be stopping at 28%. We will continue to drive up operating margin since that's a key element of our strategy.

但是我已經談了很多關於利潤率的問題，讓我們來看看這裡的營業利潤率。你可以在這裡看到我們如何從 17 年的 28.8%（原文如此）[27.8%] 下降到 19 年的 24.5%。這實際上是由於 COPAXONE 專利到期導致 COPAXONE 收入大幅下降所致。現在 COPAXONE 現在已經下線了。如您所知，今年的收入將不到 10 億美元。所以它不再是我們市場的主要因素。正如我告訴你的那樣，我們一直在努力提高毛利率和營業利潤率。我們在 5 年前或實際上 4 年前設定了一個目標，但到 2023 年底，這將是一個從 18% 到 23% 的 5 年目標。這個目標是28%。正如你所看到的，我們正在努力實現這一目標。而且我一直說，在我們達到目標之前，我們不會提出新的目標，但可能只是我們已經如此接近，以至於在今年下半年，我們實際上會與您分享未來的目標，以便您不會誤以為我們將停止在 28%。我們將繼續提高營業利潤率，因為這是我們戰略的關鍵要素。

And why is it so important? Well, the next slide tells you something about why it's important. It's because we have a starting point with too much debt. So we need to drive down the debt. And the only way to drive down the debt is to generate cash flow and allocate the cash to reducing debt. And the way to generate the cash flow is, of course, to have a higher operating margin. So therefore, the whole thing, of course, fits together. And you see here how we've been taking down debt in '17 with some roughly $13 billion. In the same period, we have, of course, been paying interest rates, about $1 billion a year. So you could say that we have paid $17 billion to the bondholders over the last years. This will continue in the coming years. And then, of course, you can all calculate that there will be a nice time when we don't need to allocate all our excess liquidity and cash to bondholders, but we can add at some point in time in the coming years, start allocating cash to the shareholders, which will, of course, be a big pleasure to reach that point.

為什麼它如此重要？好吧，下一張幻燈片會告訴您為什麼它很重要。這是因為我們的起點債務太多。所以我們需要降低債務。降低債務的唯一方法是產生現金流並將現金分配給減少債務。而產生現金流的方式當然是擁有更高的營業利潤率。因此，整個事情當然是結合在一起的。你在這裡看到我們是如何在 17 年以大約 130 億美元償還債務的。當然，在同一時期，我們支付了大約每年 10 億美元的利率。所以你可以說我們在過去幾年向債券持有人支付了 170 億美元。這將在未來幾年繼續。然後，當然，你們都可以計算出，我們不需要將所有多餘的流動性和現金分配給債券持有人，但我們可以在未來幾年的某個時間點添加，開始分配給股東現金，當然，達到這一點將是一大樂事。

Now on the way to that, we, of course, need to manage our debt, and what we call the debt stacks. That's really how much debt you need to repay every year. you need to have a good balance between your operational cash flow and the debt you are paying back every year. And last year, we did a successful refinancing of $5 billion. So basically, we borrowed $5 billion by selling bonds, and we repaid debt by $5 billion by taking out existing bonds from the market, all with the purpose of getting a more flat repayment profile that we are repaying for the next 3 years, what matches our operating cash flow, and that means that liquidity-wise has a good balance between the liquidity we generate and repaying the bonds over the next 3 years.

現在，在實現這一目標的過程中，我們當然需要管理我們的債務，以及我們所說的債務堆棧。這真的是你每年需要償還的債務。您需要在運營現金流和每年償還的債務之間取得良好的平衡。去年，我們成功進行了 50 億美元的再融資。所以基本上，我們通過出售債券借了 50 億美元，我們通過從市場上取出現有債券償還了 50 億美元的債務，所有這些都是為了獲得我們在未來 3 年償還的更平坦的還款情況，什麼匹配我們的經營現金流，這意味著流動性方面在我們產生的流動性和未來 3 年償還債券之間取得了良好的平衡。

Now we did this in a new fashion. We issued what's called sustainability-linked bonds. And that's a new thing, which makes a lot of sense for us. Because you know, we are the world's leading generic pharma company. And what do we do? Well, we really supply medicines to hundreds of millions of people in high quality so they can take care of their healthy issues. How can we do things better for the world? Well, basically by supplying more high-quality medicines at a low cost to societies all over the world. And if you look at the sort of targets we set up for these sustainability-linked bonds, and the first target is a classical climate change target. So it's a reduction in greenhouse gases by 2025, and we are well on our way to do that. And actually, it's funny because the reduction in greenhouse gases goes hand-in-hand with improvement of the gross margin. Because the best way to improve your climate footprint is to use less resources. So the more efficient you manufacture, the less resources you use in manufacturing, the less burden you are to the environment, and the better is your gross margin. So the financial targets go hand-in-hand with the environmental targets.

現在我們以一種新的方式做到了這一點。我們發行了所謂的可持續發展相關債券。這是一個新事物，對我們來說很有意義。因為您知道，我們是世界領先的仿製藥公司。我們該怎麼辦？好吧，我們確實為數億人提供了高質量的藥物，讓他們能夠照顧好自己的健康問題。我們如何才能為世界做得更好？嗯，基本上是通過以低成本向世界各地的社會提供更多高質量的藥物。如果你看看我們為這些與可持續發展相關的債券設定的目標，第一個目標是經典的氣候變化目標。因此，到 2025 年，溫室氣體排放量會有所減少，而我們正朝著這個目標邁進。實際上，這很有趣，因為溫室氣體的減少與毛利率的提高齊頭並進。因為改善氣候足蹟的最佳方法是使用更少的資源。因此，您製造的效率越高，您在製造中使用的資源就越少，您對環境的負擔就越小，您的毛利率就越高。因此，財務目標與環境目標齊頭並進。

On access, this is a thing we can do better than probably anybody else. We can manufacture the medicines that are on WHO's essential medicines list really what society needs to have a basic health care system. We can ensure that these medicines get regulatory approval in low and middle-income countries. And then we can ensure that actual volumes of the medicines are brought to the patients in these countries, all helping the health care systems. So that's what we're committed to doing, and that's what we will be doing in the coming years and reporting on, of course, so that everybody can see that we meet the targets of these new bonds.

在訪問時，這是我們可能比其他任何人都做得更好的事情。我們可以生產世界衛生組織基本藥物清單上的藥物，真正滿足社會擁有基本醫療保健系統的需求。我們可以確保這些藥物在低收入和中等收入國家獲得監管部門的批准。然後我們可以確保為這些國家的患者提供實際數量的藥物，所有這些都有助於醫療保健系統。所以這就是我們承諾要做的事情，這也是我們在未來幾年將要做的事情，當然也會報告，這樣每個人都可以看到我們實現了這些新債券的目標。

Now I talked about the debt maturity profile. Just a quick look here of what we did. So we took out, you would say, bonds maturities in '22, '23, '24, and we pushed it into '27, '28 -- sorry, '27, '29 and '30. And you can see basically taking the next 3 years down to around the $2 billion mark. And you can also see here that we will need to do 1 last refinancing before we get to '25, '26 and '27, probably of around $3 billion to $4 billion. Again, taking those debt stacks to a level of around $2 billion by pushing something into '31, '32 and so on. And that will be the last time we need to do that, then we'll have balance for the rest of the time between the debt repayments, the maturities and our operating cash flow.

現在我談到了債務到期情況。在這裡快速瀏覽一下我們所做的事情。所以我們取出了，你會說，在 22 年、23 年、24 年到期的債券，我們把它推到了 27 年、28 年——對不起，27 年、29 年和 30 年。你可以看到，接下來的 3 年基本上會降到 20 億美元左右。您還可以在這裡看到，在我們達到 25 年、26 年和 27 年之前，我們需要進行最後一次再融資，可能約為 30 億至 40 億美元。同樣，通過將某些東西推入'31、'32等，將這些債務堆棧提高到大約20億美元的水平。這將是我們最後一次需要這樣做，然後我們將在債務償還、到期和我們的經營現金流之間的剩餘時間內保持平衡。

Now let's take me to my last slide, which is a nice boring good slide, which has been there since 2018 just tells you that we are sticking to our long-term financial targets. Operating income margin, I talked about it already, 28% has to earnings above 80% to secure we have the cash from the debt repayments. And net debt, of course, coming below 3x EBITDA by the end of '23. And all this is, of course, predicated upon what you see here that we are committed to utilizing our cash to pay down debt, and we don't plan to raise any equity. We think our patient equity holders deserve to see the operate litigation go away and the debt come down and get the full value benefit of that when that happens eventually.

現在讓我們來看我的最後一張幻燈片，這是一張非常無聊的好幻燈片，自 2018 年以來一直存在，它只是告訴你我們正在堅持我們的長期財務目標。營業收入利潤率，我已經談過了，28% 的利潤必須高於 80% 才能確保我們從債務償還中獲得現金。當然，到 23 年底，淨債務將低於 3 倍 EBITDA。當然，所有這一切都是基於你在這裡看到的，即我們致力於利用我們的現金來償還債務，我們不打算籌集任何股權。我們認為我們的耐心股權持有人應該看到運營訴訟消失，債務下降，並在最終發生時獲得全部價值收益。

And with that, I'll hand over to our CFO, Eliyahu Kalif.

有了這個，我將交給我們的首席財務官 Eliyahu Kalif。

Thank you, Kare, and good morning and afternoon to everyone. I'll begin my review of our 2021 financial results with our main focus being on the fourth quarter performance. This will be followed by the introduction of our 2022 non-GAAP guidance and some of the important assumptions behind it. While most of the discussions around 2022 guidance will come at the end of my presentation, in a few spots along the way, I will touch upon our expectations regarding forward-looking trends to assist you with your modeling.

謝謝你，Kare，大家早上好，下午好。我將開始審查我們的 2021 年財務業績，主要關注第四季度的業績。隨後將介紹我們的 2022 年非公認會計原則指南及其背後的一些重要假設。雖然圍繞 2022 年指南的大部分討論將在我的演講結束時進行，但在此過程中的一些地方，我將談到我們對前瞻性趨勢的期望，以幫助您進行建模。

Beginning on Slide 23. I would like to start with our Q4 GAAP performance. Revenue in the fourth quarter of 2021 were $4.1 billion, a decrease of 8% in both U.S. dollars and local currency terms compared to the fourth quarter of 2020. This decrease was mainly due to a lower revenue from generics products in North America and COPAXONE, partially offset by higher revenues from AUSTEDO and AJOVY. As Kare mentioned earlier, our revenue continues to be affected by the ongoing impact of the COVID-19 pandemic on market and on customer stocking and purchasing patterns.

從幻燈片 23 開始。我想從我們的 Q4 GAAP 表現開始。 2021 年第四季度收入為 41 億美元，以美元和當地貨幣計算，較 2020 年第四季度下降 8%。這一下降主要是由於北美仿製藥產品和 COPAXONE 的收入下降，部分被 AUSTEDO 和 AJOVY 的收入增加所抵消。正如 Kare 之前提到的，我們的收入繼續受到 COVID-19 大流行對市場以及客戶庫存和購買模式的持續影響的影響。

For the sake of year-over-year comparison, I would like to note that Q4 2020 included generic product sales in Japan, totaling $73 million and approximately $240 million for the full year of 2020. As we have previously communicated, these products were divested as of February 1, 2021, along with the manufacturing site in Japan. As we have discussed in the past, the decrease we are seeing in our revenues from generic products in North America was mainly driven by the fewer generic product launches in 2021 compared to 2020. Foreign exchange rate movements during the fourth quarter of 2021, net of hedging effects negatively impacted revenues by $19 million compared to the fourth quarter of 2020.

為了進行同比比較，我想指出，2020 年第四季度包括日本的仿製藥銷售額，總額為 7300 萬美元，2020 年全年約為 2.4 億美元。正如我們之前所傳達的，這些產品已被剝離截至 2021 年 2 月 1 日，連同日本的製造基地。正如我們過去所討論的，我們在北美看到的仿製藥收入減少的主要原因是 2021 年推出的仿製藥與 2020 年相比有所減少。2021 年第四季度的匯率變動，扣除與 2020 年第四季度相比，對沖效應對收入產生了 1900 萬美元的負面影響。

The GAAP operating income was $78 million in Q4 '21 compared to $406 million in Q4 2020. We had a net loss of $159 million in Q4 '21 compared to the net income of $160 million in Q4 2020.

21 年第四季度的 GAAP 營業收入為 7800 萬美元，而 2020 年第四季度為 4.06 億美元。我們在 21 年第四季度淨虧損 1.59 億美元，而 2020 年第四季度淨收入為 1.6 億美元。

Turning to Slide 24. You can see that the non-GAAP adjustment in the fourth quarter of 2021 were $1.12 billion with approximately $630 million Q4 2020. Non-GAAP net income and non-GAAP earnings per share for the fourth quarter of 2021 were adjusted to exclude these items. In Q4 2021, the liability related to the Opioid litigation was increased by approximately $600 million. Additional notable non-GAAP adjustments include amortization of purchased intangible assets, totaling $188 million, the majority of which is included in cost of goods sold, and impairment of long-lived assets totaling $183 million.

轉到幻燈片 24。您可以看到 2021 年第四季度的非 GAAP 調整為 11.2 億美元，其中 2020 年第四季度約為 6.3 億美元。調整了 2021 年第四季度的非 GAAP 淨收入和非 GAAP 每股收益排除這些項目。 2021 年第四季度，與阿片類藥物訴訟相關的負債增加了約 6 億美元。其他值得注意的非公認會計原則調整包括總計 1.88 億美元的購買無形資產攤銷，其中大部分包含在銷售商品成本中，以及總計 1.83 億美元的長期資產減值。

Moving to Slide 25 for a review of our non-GAAP performance. I have already discussed our fourth quarter revenues, which totaled approximately $4.1 billion. Annual revenues were $15.9 billion, a decline of 5% compared to 2020. Now let's move down to the P&L and look on the margin. Year-over-year, total non-GAAP gross profit margin improved to 54.2% compared to 52.4% in 2020. Our Q4 '21 non-GAAP gross profit margin improved to 56.1% compared to 52.3% in Q4 2020. The increase in non-GAAP gross profit margin, both for the quarter and the year-to-date was mainly driven by improved profitability from the change in our generic product portfolio mix, mainly in our North America segment, higher sales of AUSTEDO and AJOVY as well as higher profitability in Europe and international markets, partially offset by lower revenue from Suboxone due to generic competition. The increase in our non-GAAP gross profit margin was also driven by improved profitability due to our ongoing efforts to optimize our cost of goods sold.

移至幻燈片 25 以查看我們的非公認會計原則績效。我已經討論了我們第四季度的收入，總收入約為 41 億美元。年收入為 159 億美元，與 2020 年相比下降了 5%。現在讓我們來看看損益表，看看利潤率。與去年同期相比，總非公認會計準則毛利率從 2020 年的 52.4% 提高到 54.2%。我們的 21 年第四季度非公認會計準則毛利率從 2020 年第四季度的 52.3% 提高到 56.1%。非公認會計原則的增長-本季度和年初至今的 GAAP 毛利率主要是由於我們的通用產品組合組合（主要在我們的北美部門）的變化、AUSTEDO 和 AJOVY 的銷售額增加以及更高歐洲和國際市場的盈利能力，部分被由於仿製藥競爭導致的 Suboxone 收入下降所抵消。由於我們不斷努力優化我們的銷售成本，盈利能力的提高也推動了我們非公認會計準則毛利率的增長。

Our non-GAAP operating margin was 30.4% versus 25.6% in Q4 2020. This increase was driven mainly by higher gross profit margin mentioned above. 2021 non-GAAP operating margin was 27.7% versus 26.3% in 2020. Our non-GAAP financial expenses in 2021 were mainly comprised from interest expenses, were $930 million. Looking ahead to 2022, following our recent refinancing, we expect our finance expenses to increase marginally to an annual run rate of approximately $1 billion. We ended the quarter with a non-GAAP earnings per share of $0.77 compared to $0.68 in Q4 2020, mostly due to a lower spend base.

我們的非公認會計原則營業利潤率為 30.4%，而 2020 年第四季度為 25.6%。這一增長主要是由於上述毛利率較高。 2021 年非 GAAP 營業利潤率為 27.7%，而 2020 年為 26.3%。我們 2021 年的非 GAAP 財務費用主要包括利息費用，為 9.3 億美元。展望 2022 年，在我們最近的再融資之後，我們預計我們的財務費用將小幅增加至每年約 10 億美元的運行速度。我們在本季度末的非公認會計準則每股收益為 0.77 美元，而 2020 年第四季度為 0.68 美元，主要是由於支出基數較低。

Turning to Slide 26. We see that our quarterly spend base declined by approximately 14%. Looking at the year-to-date comparison, our spend base declined $794 million or $971 million net of FX. Most of the annual decrease was due to a lower cost of goods sold, partially related to a lower annual sales as well as our ongoing efforts to transform our global operational network. Lower operating expenses also contributed to the decline in our spend base, mainly due to the ongoing active management of such expenses.

轉到幻燈片 26。我們看到我們的季度支出基數下降了約 14%。從年初至今的比較來看，我們的支出基數下降了 7.94 億美元，即扣除外匯後的 9.71 億美元。大部分年度下降是由於銷售商品成本下降，部分原因是年銷售額下降以及我們不斷努力改造我們的全球運營網絡。較低的運營費用也導致我們的支出基礎下降，主要是由於對此類費用的持續積極管理。

Looking ahead to 2022, we expect the overall spend base to remain below $12 billion as we continue to focus on our efforts on reducing our cost of goods sold through procurement cost of excellence, network optimization and restructuring, operational quality excellence, end-to-end supply chain integration and an agile operating model and organization. This ongoing effort will lead to stabilizing the operating margin above the level of 27% in 2022, with the ultimate goal being 28% operating margin by end of '23.

展望 2022 年，我們預計整體支出基數將保持在 120 億美元以下，因為我們將繼續致力於通過卓越採購成本、網絡優化和重組、卓越運營質量、端到端終端供應鏈集成和敏捷的運營模式和組織。這項持續的努力將導致營業利潤率在 2022 年穩定在 27% 的水平以上，最終目標是到 23 年底營業利潤率達到 28%。

Turning to free cash flow on Slide 27. Our free cash flow in the fourth quarter of 2021 was $716 million, extending the sequential rebound we saw in Q2 and Q3 versus Q1. The full year 2021 free cash flow was $2.2 billion compared to $2.1 billion in 2020. The increase in 2021 resulted mainly from higher cash generated from the investors and of visits and other assets, partially offset by lower profit in North America segment during 2021.

轉向幻燈片 27 上的自由現金流。我們在 2021 年第四季度的自由現金流為 7.16 億美元，延續了我們在第二季度和第三季度看到的與第一季度相比的連續反彈。 2021 年全年自由現金流為 22 億美元，而 2020 年為 21 億美元。2021 年的增長主要是由於投資者以及訪問和其他資產產生的現金增加，部分被 2021 年北美部門的利潤下降所抵消。

Turning to Slide 28. Our cash to earnings for full year 2021 was 77% versus 75% for full year 2020. The increase was mainly driven by higher free cash flow, partially offset by higher net income.

轉到幻燈片 28。我們 2021 年全年的現金收益為 77%，而 2020 年全年為 75%。這一增長主要是由較高的自由現金流推動的，部分被較高的淨收入所抵消。

Turning to Slide 29. As Kare showed before, our debt continued to decrease. Our net debt at the end of Q4 2021 was $20.9 billion compared to $23.7 billion at the end of 2020. The decrease in the gross debt was mainly due to the debt repayments as well as exchange rate fluctuations. The increase in our net debt was mainly due to our free cash flow generation during the year. Upcoming maturities include $1.4 billion in 2020. Our net debt to EBITDA continued to decline, coming in at 4.25x for Q4 '21 as we continue to make progress towards our '23 target to be under 3x by the end of that year.

轉到幻燈片 29。正如 Kare 之前所展示的，我們的債務繼續減少。我們在 2021 年第四季度末的淨債務為 209 億美元，而 2020 年底為 237 億美元。總債務的減少主要是由於債務償還和匯率波動。我們的淨債務增加主要是由於我們在年內產生了自由現金流。即將到期的債務包括 2020 年的 14 億美元。我們對 EBITDA 的淨債務繼續下降，21 年第四季度的淨債務為 4.25 倍，因為我們繼續朝著 23 年的目標取得進展，到當年年底將低於 3 倍。

We are very pleased with the successful refinancing that took place in November '21. We completed $5 billion sustainability linked bond offering and $4 billion tender offer. As part of our SLB offering, we have set ambitious KPIs to measure our contribution to social and environmental measures. Our intention is to establish a direct link between our corporate responsibility commitments and our funding strategy. This was a debt-neutral transaction Teva has been very clear and consistent with its long-term financial strategy, which includes the commitment to continue deleveraging. As Kare explained earlier, looking ahead, we are pleased with our maturity profile for '22, '23 and '24 as it's aligned with our liquidity strategy and help us focus on our long-term financial targets.

我們對 21 年 11 月成功進行的再融資感到非常高興。我們完成了 50 億美元的可持續發展掛鉤債券發行和 40 億美元的要約收購。作為我們 SLB 產品的一部分，我們制定了雄心勃勃的 KPI 來衡量我們對社會和環境措施的貢獻。我們的目的是在我們的企業責任承諾和我們的融資戰略之間建立直接聯繫。這是一項債務中性交易 Teva 非常明確並符合其長期財務戰略，其中包括繼續去槓桿化的承諾。正如 Kare 之前解釋的那樣，展望未來，我們對 22 年、23 年和 24 年的到期情況感到滿意，因為它符合我們的流動性戰略並幫助我們專注於我們的長期財務目標。

Now let's turn our attention to our 2022 non-GAAP outlook, which we are introducing for the first time today. Here on Slide 30, you will find the 5 main components of our outlook: revenues, operating income EBITDA, earnings per share and free cash flow as well as additional components, including expected revenue range for key products. Our company worked hard through 2021, navigating the ongoing impact of the pandemic. While we cannot predict the exact magnitude of COVID-19 in [2029], we expected to continue to face somewhat volatile environment with regard to the purchasing pattern of our larger global customers, overall utilization by patients, generic product launches and foreign exchange sets. With this in mind, we begin 2022 total revenue, which we expected to be between $15.6 billion and $16.2 billion. This reduction in revenue guidance compared to 2021 includes the impact of foreign exchange, and specifically the impact of the stronger U.S. dollar on our results since approximately 50% of our revenue came from sales denominated in non-U.S. dollar currencies.

現在讓我們將注意力轉向我們今天首次介紹的 2022 年非公認會計原則展望。在幻燈片 30 上，您將找到我們展望的 5 個主要組成部分：收入、營業收入 EBITDA、每股收益和自由現金流以及其他組成部分，包括主要產品的預期收入範圍。我們公司一直努力工作到 2021 年，以應對大流行的持續影響。雖然我們無法預測 [2029] 中 COVID-19 的確切規模，但我們預計在我們更大的全球客戶的購買模式、患者的整體使用、通用產品的推出和外匯組合方面，我們將繼續面臨一些不穩定的環境。考慮到這一點，我們從 2022 年開始的總收入預計在 156 億美元到 162 億美元之間。與 2021 年相比，收入指引的減少包括外彙的影響，特別是美元走強對我們業績的影響，因為我們大約 50% 的收入來自以非美元貨幣計價的銷售。

We have factored into our guidance the continued erosion of global COPAXONE revenue, which we expect to decline during 2022 by approximately $150 million to approximately $850 million. The majority of the decline is expected in the U.S.

我們已將全球 COPAXONE 收入的持續侵蝕納入我們的指導，我們預計 2022 年該收入將下降約 1.5 億美元至約 8.5 億美元。預計下降的大部分在美國。

The expected ongoing growth of AUSTEDO and AJOVY should be greater than the offsetting effect by the decline in COPAXONE sales. We expect continued momentum AUSTEDO with total annual revenue to grow to approximately $1 billion in 2022. Furthermore, AJOVY is expected to benefit from continued patient growth in the U.S., Europe and international markets. Global sales of AJOVY are expected to be approximately $400 million in 2022.

AUSTEDO 和 AJOVY 的預期持續增長應該大於 COPAXONE 銷售額下降的抵消效應。我們預計 AUSTEDO 的持續勢頭將在 2022 年增長至約 10 億美元。此外，預計 AJOVY 將受益於美國、歐洲和國際市場的持續患者增長。預計 2022 年 AJOVY 的全球銷售額約為 4 億美元。

With a modest decline expected in our spend base, our non-GAAP operating income is expected to be between $4.2 billion to $4.5 billion, and our non-GAAP EBITDA is expected to be between $4.7 billion to $5 billion, using a share count of approximately 1.1 billion shares, we expected earnings per share to be in the range of $2.40 to $2.60. As you know, we do not provide quarterly guidance, but I thought it will be helpful to share with you how we are thinking about the progression of both sales and earnings throughout the year.

由於我們的支出基數預計會適度下降，我們的非 GAAP 營業收入預計將在 42 億美元至 45 億美元之間，我們的非 GAAP EBITDA 預計將在 47 億美元至 50 億美元之間，使用的股票數量約為11 億股，我們預計每股收益在 2.40 美元至 2.60 美元之間。如您所知，我們不提供季度指導，但我認為與您分享我們對全年銷售和收益進展的看法會有所幫助。

Based on our expectation to date, we expect that the first quarter will be the lowest of the 4 quarters for sales and earnings, with a gradual pickup in the second quarter. Overall, we expect that approximately 45% of our 2022 revenue to be generated in the first half of the year and approximately 55% in the second half. I hope this color will assist you with your modeling.

根據我們迄今為止的預期，我們預計第一季度的銷售額和盈利將是四個季度中最低的，第二季度將逐步回升。總體而言，我們預計 2022 年收入的約 45% 將在上半年產生，約 55% 將在下半年產生。我希望這種顏色可以幫助您進行建模。

2022 free cash flow is expected to be in the range of $1.9 billion to $2.2 billion. Similar to 2021, we expect about 1/3 of the annual free cash flow to be generated in the first half of 2022 and 2/3 to be generated in the second half of 2022. Lastly, looking at tax. In 2021, our non-GAAP tax was 16.4%, which was below the 17% to 18% range we originally guided to. As we look ahead to 2022, we expected our tax rate to be in the range of 18% to 19%. This increase is mainly driven by the mix of products year-over-year as well as other items, which carries higher than average tax rate.

2022 年的自由現金流預計在 19 億美元至 22 億美元之間。與 2021 年類似，我們預計 1/3 的年度自由現金流將在 2022 年上半年產生，2/3 將在 2022 年下半年產生。最後，看稅收。 2021 年，我們的非公認會計原則稅率為 16.4%，低於我們最初指導的 17% 至 18% 的範圍。展望 2022 年，我們預計我們的稅率將在 18% 至 19% 之間。這一增長主要是由於產品組合的同比增長以及其他項目的稅率高於平均稅率。

This concludes my review of Teva results for the fourth quarter and fiscal year 2021, we will now open the call for questions and answers. Operator, would you please open the call for questions?

我對梯瓦 (Teva) 第四季度和 2021 財年業績的審查到此結束，我們現在將開啟問答電話。接線員，請您打開電話提問嗎？

(Operator Instructions)

（操作員說明）

And the first question comes from the line of Umer Raffat from Evercore.

第一個問題來自 Evercore 的 Umer Raffat。

I guess I'm a little confused about the AUSTEDO number reported. It's up 4% in volume quarter-over-quarter, but sales are up 40%. And it looks like the dollars per Rx are up almost 35% versus Q3. Is there something unique that happened as it relates to inventory and/or a favorable gross to net change or reconciliation? That would be very helpful. Also, perhaps on opioid theme. I noticed the headline you put out to Texas is $225 million, which is really interesting because J&J's headline for the global settlement to Texas with $290 million, meaning you're not so far off versus the headline J&J was able to successfully negotiate. So if you're really tracking as close as you are to the headline numbers versus J&J, presumably, that should form the basis for a lot more interest nationwide, especially considering your financial status, and they probably appreciate it. So why aren't we seeing more traction on a potential nationwide settlement? And just finally, just a quick one. I noticed fibromyalgia for CGRP. Did that trial not work? Because I know it wasn't even fully included yet.

我想我對報告的 AUSTEDO 號碼有點困惑。銷量環比增長 4%，但銷售額增長了 40%。看起來每 Rx 的美元與第三季度相比上漲了近 35%。是否發生了與庫存和/或對淨變化或對賬有利的總額相關的獨特情況？那將非常有幫助。此外，也許關於阿片類藥物的主題。我注意到你給德克薩斯州的標題是 2.25 億美元，這真的很有趣，因為強生公司的標題是全球和解德克薩斯州的 2.9 億美元，這意味著你與強生能夠成功談判的標題相差不遠。因此，如果您真的與 J&J 的頭條數字一樣接近，大概，這應該成為全國范圍內更多興趣的基礎，特別是考慮到您的財務狀況，他們可能會欣賞它。那麼，為什麼我們沒有看到潛在的全國性定居點的更多吸引力呢？最後，只是一個快速的。我注意到 CGRP 的纖維肌痛。那次試驗沒有用嗎？因為我知道它甚至還沒有完全包括在內。

Thank you for those 3 questions. I'll start from the last one and -- take the 2 last ones, and then I'll let Sven answer the one about AUSTEDO. So on fibromyalgia, it's correct that we have had a, what we call it, a futility analysis done. And the conclusion of that by the experts who look into it was that it would be futile to continue the trial. So we will not be continuing looking into fibromyalgia . So that's absolutely correct observed.

謝謝你的這3個問題。我將從最後一個開始，然後——拿最後兩個，然後我會讓 Sven 回答關於 AUSTEDO 的那個。因此，關於纖維肌痛，我們已經進行了一項我們稱之為無效的分析，這是正確的。對此進行調查的專家得出的結論是，繼續審判是徒勞的。所以我們不會繼續研究纖維肌痛。所以這是絕對正確的觀察。

On the opioid piece, you could say that we are still optimistic, as I said, that we can reach a nationwide settlement in the coming 12 months. We have been, of course, in constant dialogue over the last couple of years. And you, of course, remember the initial framework, which was less cash and more product. It was $250 million nationwide in cash and $23 billion in product. And that didn't really fly. And I think it's fair to say the reason why that didn't really fly was mainly because the plaintiff lawyers, they basically did not see any fees coming in from the product part, and that means that it was not attractive to them. Whereas the new balance we have in Texas where you could say we have 1/3 in products, $75 million of Narcan generic Narcan spray, which is a very good thing for treatment of opioid overdoses. And then the other 2/3, $150 million in cash over a period of years. I think that's a more appealing setup.

關於阿片類藥物，你可以說我們仍然樂觀，正如我所說，我們可以在未來 12 個月內達成全國性解決方案。當然，在過去的幾年裡，我們一直在不斷地對話。當然，您還記得最初的框架，即更少的現金和更多的產品。全國范圍內有 2.5 億美元的現金和 230 億美元的產品。這並沒有真正飛起來。而且我認為公平地說，之所以沒有真正成功，主要是因為原告律師，他們基本上沒有看到產品部分有任何費用，這意味著它對他們沒有吸引力。鑑於我們在德克薩斯州的新平衡，您可以說我們擁有 1/3 的產品，價值 7500 萬美元的 Narcan 仿製藥 Narcan 噴霧劑，這對於治療阿片類藥物過量是一件非常好的事情。然後是另外 2/3，即 1.5 億美元的現金。我認為這是一個更有吸引力的設置。

So I would agree with you that based on us doing this, there's probably now a higher probability that we can reach a nationwide settlement. And I will then pass on to Sven on answering the AUSTEDO question.

所以我同意你的觀點，基於我們這樣做，我們現在可能更有可能達成全國性解決方案。然後我將繼續回答 Sven 的 AUSTEDO 問題。

Yes. Thanks, Kare. So Umer, in the second half of 2021, we had 63% higher script count for AUSTEDO than in the first half of 2021. So we had a very good trajectory. Actually, December was our strongest month in the year, and it also saw the strongest step-up. So in context of that, we also know that the Q4 quarter is always the strongest one for AUSTEDO. We have spec buying by the wholesaler as Kare alluded to earlier due to the price increase that we took for January 2022. And that was 1 factor. The second one, as I explained, was the script count, and we saw a slight improvement in daily dose per patient, which also contributed to a strong quarter 4 in last year. Thank you.

是的。謝謝，凱爾。所以 Umer，在 2021 年下半年，AUSTEDO 的劇本數量比 2021 年上半年高出 63%。所以我們的發展軌跡非常好。實際上，12 月是我們一年中表現最強勁的月份，也是最強勁的升幅。因此，在此背景下，我們也知道第四季度始終是 AUSTEDO 最強勁的季度。由於我們在 2022 年 1 月採取的價格上漲，我們有批發商購買的規格，正如 Kare 早些時候提到的那樣。這是一個因素。正如我所解釋的，第二個是腳本計數，我們看到每位患者的每日劑量略有改善，這也促成了去年第四季度的強勁增長。謝謝你。

And the next question comes from the line of Ronny Gal from Bernstein.

下一個問題來自 Bernstein 的 Ronny Gal。

If you don't mind, quick 3 ones. One, with risperidone LAI, do you own this royalty-free or is there some stream that comes out of that? Second, can you give us a feel for the biosimilar margins in your partnerships, even those are becoming a bigger product. Is this dilutive or accretive to your gross margin? And third, can you talk a little bit about your sensitivity to interest rates? Essentially, there's a 1% increase in interest rates in 2022. How much will that impact your earnings if we think about 2023 and beyond, just to give us a feel for the sensitivity there?

如果你不介意，快3個。一，使用利培酮 LAI，您是否擁有這種免版稅的產品，還是有一些由此產生的流量？其次，您能否讓我們了解一下您的合作夥伴關係中的生物仿製藥利潤率，即使那些正在成為更大的產品。這會稀釋還是增加您的毛利率？第三，你能談談你對利率的敏感性嗎？從本質上講，2022 年利率會增加 1%。如果我們考慮 2023 年及以後的時間，這會對您的收入產生多大影響，只是為了讓我們感受一下那裡的敏感性？

Thank you very much, Ronny. I think I need to just to repeat the first question about Risperidone LAI. What is the specific question?

非常感謝你，羅尼。我想我需要重複關於利培酮 LAI 的第一個問題。具體問題是什麼？

On royalty on this or the only royalty free.

關於版稅就這個還是唯一的免版稅。

Okay. So this product is developed by us based on in-license technology from MedinCell. They have a prolongation technology that we're using for this product. And we also have olanzapine LAI in development using the same technology. And we are paying a small royalty on the product. It's not dilutive to our margins when we launched risperidone LAI in the product. We expect the overall margin of risperidone LAI to be good and healthy. So we are very optimistic about the fact that we can grab a reasonable volume share and also market share in value of the long-acting segment, simply by offering a more convenient and better dosing with unbeaten efficacy. So I guess that covers the first 2 questions because that was also the question about the margin. And please correct me if I'm wrong there, Ronny. Then on the interest...

好的。所以這個產品是我們基於MedinCell的in-license技術開發的。他們有一項我們用於該產品的延長技術。我們還使用相同的技術開發了奧氮平 LAI。我們正在為該產品支付少量版稅。當我們在產品中推出利培酮 LAI 時，這並沒有稀釋我們的利潤。我們預計利培酮 LAI 的整體利潤率良好且健康。因此，我們非常樂觀地認為，我們可以通過提供更方便、更好的劑量和不敗的療效，在長效細分市場中獲得合理的銷量份額和市場份額。所以我想這涵蓋了前兩個問題，因為這也是關於邊距的問題。如果我錯了，請糾正我，羅尼。然後利息...

Yes. The second question was around the biosimilar partnership margins. Is this accretive or dilutive to your gross margin?

是的。第二個問題是關於生物仿製藥合作的利潤。這對您的毛利率是增加還是稀釋？

Okay. So no, they're not. It's basically so that you could say, biosimilars, of course, have higher development costs. But the -- once you get into the actual market, even with a split with a partner, it's a margin that can compete with traditional generics. So it's not diluting. It's, of course, not the same margin as a specialty patented products such as COPAXONE, for instance. But if you look at our overall margins, then our biosimilar in-licensed products can match the overall margins we have.

好的。所以不，他們不是。基本上可以說，生物仿製藥當然有更高的開發成本。但是——一旦你進入實際市場，即使與合作夥伴分道揚鑣，它也是可以與傳統仿製藥競爭的利潤。所以它沒有稀釋。當然，這與 COPAXONE 等專業專利產品的利潤率不同。但是，如果您查看我們的整體利潤率，那麼我們的生物仿製藥許可產品可以與我們的整體利潤率相匹配。

Then the last question on the interest rate. First, I'll just note that all our debt is based on bonds that have been sold in the marketplace. So they are not really in any way influenced by any moves in interest rates. So the simple question is that all the $20 billion of debt we had, the interest rate is locked. So there's no effect of interest rates going up and down over the coming years, which means we can predict our finance cost extremely precise. The only swing factor is, in a way, the exchange rate between dollars and euros because some of the debt is in euros. And of course, there's a conversion there into dollars, which can affect both the size of the net debt, whether the euro goes up and down versus the dollar, and also a little bit the size of the yearly interest rate payments. But other than that, it's very, very predictable due to the fact that it's all locked in, and we don't have any variable interest rate on any of our debt. Thank you for the questions.

然後是關於利率的最後一個問題。首先，我要指出的是，我們所有的債務都是基於在市場上出售的債券。因此，它們實際上並沒有受到任何利率變動的影響。所以一個簡單的問題是，我們所有的 200 億美元債務，利率都被鎖定了。因此，未來幾年利率上下波動沒有影響，這意味著我們可以非常精確地預測我們的財務成本。在某種程度上，唯一的波動因素是美元和歐元之間的匯率，因為一些債務是以歐元計價的。當然，還有一種轉換成美元的過程，這會影響淨債務的規模，歐元兌美元的匯率是否漲跌，以及年利率支付的規模。但除此之外，它是非常非常可預測的，因為它都被鎖定了，而且我們的任何債務都沒有任何可變利率。謝謝你的提問。

And the next question comes from the line of Elliot Wilbur from Raymond James.

下一個問題來自 Raymond James 的 Elliot Wilbur。

First question, perhaps for Eli. In light of the strong gross margin performance and the roughly 180 basis point year-over-year improvement. Could you just provide us with some color or insight into expected gross margin trends in 2022? Just trying to get a little bit better sense of the ongoing benefit from manufacturing rationalization versus the lighter top line outlook, and probably what is going to be a more favorable mix impact.

第一個問題，也許是針對 Eli。鑑於強勁的毛利率表現和同比增長約 180 個基點。您能否為我們提供一些關於 2022 年預期毛利率趨勢的信息或見解？只是試圖更好地了解製造合理化與較輕的頂線前景所帶來的持續利益，以及可能會產生更有利的混合影響。

Then a follow-up question for Kare on AUSTEDO trends. Obviously, this is going to be the key growth driver within the branded segment for the next several years, the TD population remains very underpenetrated, under captured I know you guys have initiated some patient activation efforts to capture more of that market, and we're starting to see some incremental gains there, but perhaps slower than expected. The question really is, if you look at external expectations, the market does not really see that product growing much over the next 5 to 7 years. And you guys really haven't said anything about peak expectations for the product. So if there's any color you can provide in terms of sort of where you think this product can be in 5 to 7 years versus the roughly $1.3 billion that external estimates project.

然後是 Kare 關於 AUSTEDO 趨勢的後續問題。顯然，這將成為未來幾年品牌細分市場的關鍵增長動力，TD 人口仍然非常低，未捕獲我知道你們已經啟動了一些患者激活工作以佔領更多的市場，我們那裡重新開始看到一些增量收益，但可能比預期的要慢。真正的問題是，如果你看看外部預期，市場並沒有真正看到該產品在未來 5 到 7 年內增長很大。你們真的沒有說過對產品的最高期望。因此，如果您可以提供任何顏色，就您認為該產品在 5 到 7 年內可能出現的位置而言，而外部估計項目約為 13 億美元。

So Eli, you first for the margin?

那麼Eli，你首先是為了利潤嗎？

Yes. Thanks, Elliot, for the question. So just back a bit to the prepared remarks of Kare. You saw how we're getting reduced, mostly our manufacturing sites. And as Kare mentioned, we still on top of the 50 that we're able to be that position, we have more planned around that one, which means that the core manufacturing cost is going to reduce as well in 2022. So when we are doing our kind of the modeling, we're not really heavily considering on getting a benefit on a mix of products, which means that in 2022, we're most likely going to talk between 50 to 100 additional basis points on our gross margin.

是的。謝謝艾略特的問題。因此，請稍微回顧一下 Kare 準備好的評論。你看到我們是如何減少的，主要是我們的生產基地。正如 Kare 所提到的，我們仍然處於能夠擔任該職位的 50 人之首，我們圍繞該職位進行了更多計劃，這意味著核心製造成本也將在 2022 年降低。所以當我們處於在進行我們的建模時，我們並沒有認真考慮從混合產品中獲得收益，這意味著到 2022 年，我們很可能會在毛利率上增加 50 到 100 個基點。

Thank you, Eli. Yes, we keep on pushing and you should expect also longer term that we'll keep on pushing the gross margin up by classical consolidation, optimization, rationalization.

謝謝你，伊萊。是的，我們會繼續推動，您也應該期望長期來看，我們將通過經典的整合、優化、合理化繼續推動毛利率上升。

Now on to AUSTEDO, 5 to 7 years out. As you probably know, I never get peak sales on any product because there are so many assumptions. People always forget the assumptions and just think about the number. But I'd love to discuss what we think will happen with AUSTEDO over the coming years. And we think that AUSTEDO will keep on growing nicely, basically due to the clinical benefits of the product and the large unmet medical need that you allude to yourself that I also showed on a slide.

現在到 AUSTEDO，5 到 7 年。你可能知道，我從來沒有在任何產品上獲得過銷售高峰，因為有太多的假設。人們總是忘記假設，只考慮數字。但我很想討論我們認為未來幾年 AUSTEDO 會發生什麼。我們認為 AUSTEDO 將繼續保持良好增長，主要是由於該產品的臨床益處以及您提到的大量未滿足的醫療需求，我也在幻燈片上展示了這些需求。

If you want to think about it conceptually, then we will probably get more patients. And there's also a chance we'll keep them longer and they will be titrated faster. So we will see growth, which this year, we are estimating that it will be growing $200 million. I don't see any reason why that absolute growth should slow down over the coming years. And then you can do your own math and see what peak sales you get to 5 to 7 years out. But I do agree with you that, that number is higher than $1.3 billion for sure. But maybe Sven, you can just comment on what are we seeing in terms of the plans to optimize both titration and product presentation and so on, on AUSTEDO?

如果你想從概念上考慮它，那麼我們可能會得到更多的患者。我們也有可能將它們保留更長時間，並且它們會更快地滴定。因此，我們將看到增長，今年我們估計將增長 2 億美元。我看不出有任何理由說明這種絕對增長在未來幾年會放緩。然後你可以自己計算一下，看看你在 5 到 7 年後會達到什麼峰值。但我同意你的觀點，這個數字肯定高於 13 億美元。但也許 Sven，您可以就我們在 AUSTEDO 上優化滴定和產品展示等方面的計劃發表評論嗎？

Yes. I think we -- I see the three sources for growth for us. One is, of course, the patient number. We need to activate more patients and improve the diagnosis rate for Tardive Dyskinesia with our physician group. That's number one. That's what we're already doing with our field force and with our recently launched TV campaign.

是的。我認為我們 - 我看到了我們增長的三個來源。其中之一當然是患者編號。我們需要與我們的醫師團隊一起激活更多的患者並提高遲發性運動障礙的診斷率。那是第一名。這就是我們已經對我們的現場部隊和我們最近推出的電視活動所做的事情。

The second element for growth for us is working better with the patients to reach an optimal titration so dose per day level because that's directly correlated with the clinical benefits of this drug. And there, we see -- when you look at the current treatment rates and where the long-term data for this product stands that there's still an ability to optimize the treatment rate. And the third element is something that we learned, of course, also with our COPAXONE franchise is adherence here is a key element for a chronic disease, especially for this patient population. And that's, I think, the third element for growth for us.

對我們來說，增長的第二個要素是與患者更好地合作，以達到最佳滴定劑量，因此每天的劑量水平與這種藥物的臨床益處直接相關。在那裡，我們看到 - 當您查看當前的治療率以及該產品的長期數據時，仍然有能力優化治療率。第三個要素是我們學到的東西，當然，我們的 COPAXONE 特許經營權也是堅持這裡是慢性病的關鍵要素，特別是對於這個患者群體。我認為，這是我們增長的第三個要素。

Thanks, Sven. Thank you for the questions.

謝謝，斯文。謝謝你的提問。

And the next question comes from the line of Navann Ty from Citi.

下一個問題來自花旗的 Navann Ty。

What are your COVID assumptions behind the 2022 guidance? So do you assume a lingering impact on the generics business? And then my second question is on costs. So the midpoint 2022 EBITDA margin will be slightly lower. So can you comment on your SG&A and R&D assumptions for 2022? And then just a quick one on opioids. The Texas settlement, was it in line with your expectation? Was it driven by -- say that market share in the state, especially if we compare versus your peer Endo?

您對 2022 年指南的 COVID 假設是什麼？那麼，您是否認為對仿製藥業務的影響揮之不去？然後我的第二個問題是關於成本的。因此，2022 年的中點 EBITDA 利潤率將略低。那麼您能否評論一下您對 2022 年的 SG&A 和 R&D 假設？然後只是關於阿片類藥物的快速介紹。德州定居點，符合你的預期嗎？它是由該州的市場份額驅動的，尤其是當我們與您的同行 Endo 進行比較時？

Thank you for those 3 questions. I will handle the first and the last, and then Eli will comment on the SG&A piece. So our assumptions for COVID, this year is a relatively optimistic assumption, you could say, in the sense, but also cautious on the guidance range that you would say the lower end of the guidance will only happen if we see a continued negative effect from COVID. And we are optimistic that we are seeing now openings in of society in U.S., in Europe and in general, a high level of economic activity. And we see prescription levels in Europe getting close to what they were in 2019, still a little bit below but we're optimistic that we will get back to the '19 level and above in terms of the total volumes in the marketplace, not specifically for us, but just in general.

謝謝你的這3個問題。我將處理第一個和最後一個，然後 Eli 將評論 SG&A 文章。因此，我們對 COVID 的假設，今年是一個相對樂觀的假設，你可以說，在某種意義上，但對指導範圍也持謹慎態度，你會說指導的下限只有在我們看到持續的負面影響時才會發生冠狀病毒病。我們樂觀地看到，我們現在看到美國、歐洲以及總體上高水平的經濟活動的社會開放。我們看到歐洲的處方水平接近 2019 年的水平，仍略低，但我們樂觀地認為，就市場總量而言，我們將回到 19 年及以上的水平，而不是具體而言對我們來說，但只是一般。

So that is really our assumption. But you will see also that we have like -- and you alluded to, we have widened the range on our revenues because there is, of course, the risk that we will see some kind of continued new lockdowns or whatever. And we have to be able to manage that within our guidance if that happens. So that's on the COVID piece.

所以這確實是我們的假設。但是你也會看到我們喜歡 - 你提到過，我們擴大了收入範圍，因為當然，我們有可能會看到某種持續的新封鎖或其他情況。如果發生這種情況，我們必須能夠在我們的指導下進行管理。這就是 COVID 部分。

Then I'll handle the opioid piece. The way you should think about it when we think about the possibilities of a nationwide settlement is really we are thinking along the lines of the way it was done by J&J and the 3 big distributors. And that is really a formula where you say that it's mainly population-based, but it's skewed a little bit so that the smaller population states get a slightly higher percentage than the straight out population calculation.

然後我會處理阿片類藥物。當我們考慮在全國范圍內解決的可能性時，您應該考慮的方式實際上是我們按照強生和 3 大分銷商的方式進行思考。這實際上是一個公式，您說它主要基於人口，但它有點傾斜，因此人口較少的州獲得的百分比略高於直接人口計算的百分比。

What does that mean? It basically means that if you do a straight out population calculation, then you would say that with the population in Texas, a nationwide settlement would be 12x the taxes settlement. If you do the percentage that went into the nationwide settlements of J&J, then you would roughly have to move aside by 16. But it's really population based. It's not related to anything specific about individual products or anything like that. That's the principle that we expect if we are successful with a nationwide settlement, that's the principle that we expect will be used there. And then the last question about SG&A. Eli?

這意味著什麼？這基本上意味著，如果您直接進行人口計算，那麼您會說以德克薩斯州的人口計算，全國范圍內的結算將是稅收結算的 12 倍。如果你按照進入強生全國定居點的百分比計算，那麼你大約需要移動 16 倍。但它實際上是基於人口的。它與個別產品或類似的任何特定內容無關。如果我們在全國范圍內取得成功，這就是我們期望的原則，這就是我們期望在那裡使用的原則。然後是關於 SG&A 的最後一個問題。伊萊？

Yes. So thanks, Navann, for your question. You asked both on R&D and SG&A. So I think that overall, if you look on the first half of '21 versus the first -- second half '21, it's more or less the same in terms of dollars. There are some variable elements in between Q4 that we were able actually to manage in terms of priorities. Overall, our OpEx went down to 26.5%, same for the R&D. It's all about vitalization of projects, so nothing there specific.

是的。所以謝謝你，納萬，你的問題。您詢問了研發和 SG&A。所以我認為總的來說，如果你看一下 21 年上半年與 21 年上半年 - 下半年，就美元而言，它或多或少是相同的。在第四季度之間有一些可變因素，我們實際上能夠根據優先級進行管理。總體而言，我們的運營支出下降到 26.5%，與研發相同。這都是關於項目的活力，所以沒有什麼具體的。

Thank you for the questions.

謝謝你的提問。

And the next question comes from the line of Chris Schott from JPMorgan.

下一個問題來自摩根大通的 Chris Schott。

Just 2 for me. First, I just wanted to confirm, I think you mentioned that the first half sales would be 45% of total for the year. I think it's a bit more skewed kind of first half versus second half than we've typically seen. And I'm just trying to elaborate maybe a bit more of what's driving that swing. And the second one is maybe a bigger picture question on North American generics. I think in the past, you talked about kind of a $4 billion run rate as your target here. I think you've been below that for the past few quarters. Can you talk a little bit about what needs to happen to get back to that type of level? And is that something reasonable to think about as we go through 2022 as you think about whatever launches you have, et cetera, as we go through the year?

對我來說只有2個。首先，我只是想確認一下，我想你提到上半年銷售額將佔全年總銷售額的 45%。我認為上半場與下半場的情況比我們通常看到的要扭曲一些。我只是想詳細說明一下推動這種搖擺的原因。第二個問題可能是關於北美仿製藥的一個更大的問題。我認為過去，您在這裡談到過 40 億美元的運行率作為您的目標。我認為過去幾個季度你一直低於這個水平。你能談談要回到那種水平需要發生什麼嗎？在我們度過 2022 年時，當您考慮您在這一年中推出的任何產品等等時，考慮這些是否合理？

Thanks for the questions, Chris. I will comment on the first one, and then Sven will comment on the second, North American question. So it's correct that it is probably a bit more skewed than what we've seen in other years, but it's very sensitive to when we have launches. And what we're estimating this year, and Sven can comment on some of the North American ones. We are estimating that we will see more launches that will affect the second half, then we will see affect first half. So we're not really caring like we carried to TRUVADA and Atripla into the first quarter of 2021.

謝謝你的問題，克里斯。我將評論第一個問題，然後 Sven 將評論第二個北美問題。所以它可能比我們在其他年份看到的更偏斜是正確的，但它對我們何時發布非常敏感。以及我們今年的估計，Sven 可以評論一些北美的。我們估計我們會看到更多影響下半年的發布，然後我們會看到影響上半年。因此，我們並沒有真正關心我們將 TRUVADA 和 Atripla 帶到 2021 年第一季度的情況。

If you look at our U.S. generic sales, we still had some of that tail in the first quarter of last year. We don't have a big launch that we did, you would say, fourth quarter of '21 that we are carrying into the first quarter of '22. We do have launches coming up, risperidone LAI, several generic launches. So those will mainly affect the second half. And then we do have the basic seasonality that we've had always that most pharma companies have that we have the donut hole on those various things on rebate schemes and so on. That takes down the first quarter. And you typically have the reverse thing happening in the fourth quarter. So it's maybe slightly more skewed than normal, but there's nothing really extraordinary behind it other than our operational plans.

如果你看看我們在美國的仿製藥銷售，我們在去年第一季度仍然有一些尾巴。您會說，我們沒有像 21 年第四季度那樣進行大規模發布，我們將在 22 年第一季度進行。我們確實有即將推出的產品，利培酮 LAI，一些通用產品的推出。所以這些將主要影響下半年。然後我們確實擁有大多數製藥公司一直擁有的基本季節性，我們在回扣計劃等各種事情上都有甜甜圈洞。這導致第一季度下降。你通常會在第四季度發生相反的事情。所以它可能比正常情況稍微偏斜一些，但除了我們的運營計劃之外，它背後並沒有什麼特別之處。

And maybe Sven, you can comment on the $4 billion run rate for U.S. Generics run North America -- we should just make sure we always make it clear that talking about North America. So it's really U.S. and Canada. But over to you, Sven.

也許斯文，你可以評論一下美國仿製藥在北美的 40 億美元運行率——我們應該確保我們始終明確談論北美。所以它真的是美國和加拿大。但是交給你，斯文。

Yes. The North American generics sales are reported in 3 segments: biosimilars, Teva Canada and the U.S. generics business. So in 2020, we were above the $4 billion target. And in 2021, we were below the $4 billion target. And I think the 2 years, I tell you how it goes. It goes -- in 2020, we had quite a strong biosimilar business and an excellent launch of generics with TRUVADA and Atripla, and that was absent from 2021. And that gives you an idea how we think about the $4 billion as it -- basically, in a year where you have a good generics launch in complex generics with a large originator value to address or you have a biosimilar launch. We're quite confident that we get to the $4 billion sales.

是的。北美仿製藥銷售報告分為 3 個部分：生物仿製藥、Teva Canada 和美國仿製藥業務。所以在 2020 年，我們超過了 40 億美元的目標。而在 2021 年，我們低於 40 億美元的目標。我認為這 2 年，我告訴你它是怎麼回事。確實如此——在 2020 年，我們擁有相當強大的生物仿製藥業務，並與 TRUVADA 和 Atripla 一起推出了出色的仿製藥，而這在 2021 年就沒有了。這讓你知道我們如何看待這 40 億美元——基本上，在這一年，您在復雜仿製藥中推出了良好的仿製藥，具有較大的原創者價值，或者您推出了生物仿製藥。我們非常有信心達到 40 億美元的銷售額。

Thank you. Thank you for the questions.

謝謝你。謝謝你的提問。

The next question comes from the line of Gary Nachman from BMO Capital Markets .

下一個問題來自 BMO Capital Markets 的 Gary Nachman。

Kare, we were previously talking about 2021 as a trough year. Are you confident now that '22 should be a trough year in terms of revenue and EPS, especially if COVID normalizes? That's first. Second, on the opioid litigation, if the nationwide settlement ends up being, I guess, 1/3 product, 1/3 cash, is that something that you can actually absorb with your balance sheet, that type of mix? It seems like you're sort of going down that path. And then with risperidone LAI, just curious, do you have the sales force in place to launch this product, talk about maybe some prelaunch activities that you're doing, and if there'll be any real incremental spend on this in the back half of the year?

Kare，我們之前曾將 2021 年視為低谷年。您現在是否有信心，就收入和每股收益而言，22 年應該是低谷的一年，尤其是在 COVID 正常化的情況下？這是第一個。其次，關於阿片類藥物訴訟，我猜，如果全國范圍內的和解最終是 1/3 的產品，1/3 的現金，那是不是你可以用你的資產負債表實際吸收的東西，那種類型的組合？看起來你正在走這條路。然後是利培酮 LAI，只是好奇，你是否有合適的銷售人員來推出這個產品，談談你正在做的一些預發布活動，以及在後半部分是否會有任何真正的增量支出年度？

Thanks for those 3 questions. I'll address the first 2 ones and then Sven will address the risperidone question. So I can confirm that I am expecting that 2022 will be the trough years, so to speak. Or the combination of '21 and '22, you could say, unfortunately, will be the 2 trough years. And the reason being that is, of course, that I'm expecting that we will see a normalization of the volumes in Europe and U.S. And what we're talking about is probably that volumes in '21 were, let's say, 4% -- something like that. 4% to 5% below what we would have expected if we had seen 0 effect of COVID on the volume of doctor visits, hospital visits and so on for diseases not related to COVID-19. And you combine that with the dynamics of COPAXONE now, have come down to around below $1 billion this year. And it will keep going down, but of course, the absolute amount is less and less and the growth number on AUSTEDO and AJOVY is getting higher and higher. So I'm confident that that's the case also because we have a good grip on the margins, as you can see. And that means that if we just get a marginal increase on revenues, then we will also see an increase in EPS.

謝謝這3個問題。我將解決前兩個問題，然後 Sven 將解決利培酮問題。所以我可以確認，我預計 2022 年將是低谷年，可以這麼說。或者 '21 和 '22 的組合，不幸的是，你可以說，這將是 2 個低谷年。當然，原因是我預計我們將看到歐洲和美國的交易量正常化。我們正在談論的可能是 21 年的交易量是，比如說，4% - - 類似的東西。如果我們看到 COVID 對與 COVID-19 無關的疾病的就診量、醫院就診量等的影響為 0，則比我們預期的低 4% 到 5%。再加上 COPAXONE 現在的動態，今年已降至 10 億美元以下。而且還會繼續下降，當然，絕對數量越來越少，AUSTEDO和AJOVY的增長數字越來越高。所以我相信情況也是如此，因為我們很好地控制了邊緣，正如你所看到的。這意味著，如果我們只是獲得收入的邊際增長，那麼我們也會看到每股收益的增長。

So that's with regard to the trough year. With regard to the opioids and the balance sheet, then what you have seen in Texas is a payment schedule over 15 years for the cash component, which is 2/3 of the settlement value and then a -- we provide products over 10 years, and that's 1/3 of the settlement. And by, you could say, spreading it over many years, we're basically able to manage this within our balance sheet structure. If we were to pay it all tomorrow, that would, of course, not be possible given the debt we have. So it's a way of finding a way to get a settlement that benefits everybody, including the American people, the people suffering from substance abuse. And actually by adding the product component in there, you get the benefit directly to people suffering from substance abuse and having an overdose situation. And you actually have a nice twist to this because the generic Narcan spray product is actually manufactured in the U.S. on a dedicated manufacturing setup that we've created in Salt Lake City in one of our manufacturing plants there. So it's also good for U.S. manufacturing that you have here something that helps the U.S. population being manufactured in the U.S. So I think it's a very good settlement. I hope it can inspire everybody to reach a nationwide settlement, and we will be able to manage that within our balance sheet. Now the last question on risperidone, over to you, Sven.

所以這是關於低谷的一年。關於阿片類藥物和資產負債表，那麼您在德克薩斯州看到的是現金部分的付款時間表超過 15 年，這是結算價值的 2/3，然後——我們提供超過 10 年的產品，這是結算的1/3。通過，你可以說，將它分散多年，我們基本上能夠在我們的資產負債表結構中管理它。如果我們明天要付清所有的錢，那當然是不可能的，因為我們有債務。因此，這是一種尋找解決方案的方法，該解決方案有利於所有人，包括美國人民和遭受藥物濫用的人們。實際上，通過在其中添加產品成分，您可以直接為遭受藥物濫用和服用過量情況的人帶來好處。你實際上對此有一個很好的轉折，因為通用的 Narcan 噴霧產品實際上是在美國製造的，我們在鹽湖城的一個製造工廠中創建了一個專門的製造裝置。所以這對美國製造業也有好處，你在這裡有一些東西可以幫助美國人口在美國製造。所以我認為這是一個非常好的解決方案。我希望它可以激勵每個人達成一個全國性的解決方案，我們將能夠在我們的資產負債表內管理它。現在關於利培酮的最後一個問題交給你了，斯文。

Yes. So the commercial organization is in place, including the sales force, and we finance this by reallocating resources within our budget. And yes, we will see a step-up in the SG&A spend when we launch the product.

是的。所以商業組織已經到位，包括銷售人員，我們通過在預算內重新分配資源來為此提供資金。是的，當我們推出該產品時，我們將看到 SG&A 支出的增加。

And there is one more question from Jason Gerberry from Bank of America.

美國銀行的 Jason Gerberry 還有一個問題。

Just one other follow-up on the opioid front. I think there's a February 25 deadline for final implementation for the J&J distributor side of the equation. So is that too little time for Teva to negotiate its way into the deal? Or would participation in a global deal have to happen subsequently? I'd imagine your counterparties would love a much bigger top line to announce to its constituents. So I'm just curious if we're too late in the game there. And then ultimately, how do you leverage the existing framework? And then ultimately, when we look at the final opt-in later this month, how much residual litigation burden after the settlement would be unsatisfactory versus how would you characterize true global piece in a global settlement?

只是阿片類藥物方面的另一項後續行動。我認為強生經銷商方面的最終實施截止日期為 2 月 25 日。那麼梯瓦（Teva）談判達成交易的時間太少了嗎？還是必須隨後參與全球交易？我想您的交易對手會喜歡向其選民宣布更大的收入。所以我只是好奇我們在那裡的比賽是否為時已晚。最後，您如何利用現有框架？最後，當我們在本月晚些時候查看最終選擇加入時，和解後有多少剩餘訴訟負擔會令人不滿意，而您如何描述全球和解中真正的全球部分？

Aiming, of course, at reaching a nationwide settlement within the next 12 months. It's not our aim to join into communication around the settlements that J&J and the 3 distributors have been reaching. We see that as our settlement will most likely be communicated separately. And it's also different in that we have a product component, which nobody else has. So that's how we see that. In terms of how do you get piece, so to speak, how to get a comprehensive holistic settlement. It's really all about the subdivisions. So if you look at what we did in Louisiana and what we did in Texas, it basically includes all the subdivisions. So if you think about nationwide settlement, you have the same situation for us, as you've seen for J&J and the distributors. You need to get into the [90s] in terms of how many stock divisions go along with it because otherwise, you will just have too much of a tail of litigation out there.

當然，目標是在未來 12 個月內達成全國性解決方案。我們的目標不是圍繞強生和 3 家分銷商達成的和解進行溝通。我們認為，我們的和解很可能會單獨溝通。而且它的不同之處還在於我們有一個產品組件，這是其他人沒有的。這就是我們的看法。就如何獲得一塊而言，可以說，如何獲得一個全面的整體解決方案。這真的是關於細分的。因此，如果您查看我們在路易斯安那州和德克薩斯州所做的事情，它基本上包括所有細分市場。因此，如果您考慮全國范圍內的結算，您會遇到與強生和分銷商相同的情況。你需要進入 [90 年代] 有多少股票部門隨之而來，否則，你將有太多的訴訟尾巴。

What I've been seeing, and I'm not -- I don't have any insights over and above what's publicly available is, of course, that we are seeing increasing participation rates for the J&J and the distributors settlements from the subdivisions. And from what I've been reading, we are in the 90s , and we're really seeing a majority of states and majority of subdivisions going along with this. And I think that it just makes sense because it makes sense for the population. It makes sense for the states. It makes sense on the (inaudible). It makes sense for the companies. And I don't see a lot of subdivisions eventually actually trying to go to trial and going up against their states as a whole vehicle twist to this, which I won't get into, but it's problematic for a county or a city to really pursue this once the state has settled. And I don't think we'll see much of that. I hope that answers the question.

我所看到的，但我沒有看到的——當然，除了公開可用的信息之外，我沒有任何見解，我們看到強生和分銷商和解的參與率越來越高。從我一直在閱讀的內容來看，我們處於 90 年代，我們確實看到大多數州和大多數細分市場都在這樣做。而且我認為這很有意義，因為它對人們有意義。這對各州來說是有意義的。這在（聽不清）上是有道理的。這對公司來說是有意義的。而且我沒有看到很多細分市場最終實際上試圖去審判並與他們的州對抗，作為一個整體扭曲這一點，我不會進入，但對於一個縣或一個城市來說，真正的問題是一旦國家安定下來，就繼續這樣做。而且我認為我們不會看到太多。我希望這能回答這個問題。

Please continue with your closing remarks.

請繼續您的結束語。

So thank you, everyone, for joining the call. It was a pleasure taking the questions and talking to you, and I wish you all a nice and safe day. Bye-bye.

所以，謝謝大家加入電話會議。很高興接受這些問題並與您交談，祝大家度過愉快而安全的一天。再見。

Thank you. That does conclude our conference for today. Thank you for participating. You may all now disconnect.

謝謝你。這確實結束了我們今天的會議。感謝您的參與。你們現在都可以斷開連接了。