Teva Pharmaceutical Industries Ltd (TEVA) 2022 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Teva's Third Quarter 2022 Financial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Ran Meir, Senior Vice President, Head of Investor Relations.

美好的一天，謝謝你的支持。歡迎參加 Teva 2022 年第三季度財務業績電話會議。 （操作員說明）請注意，今天的會議正在錄製中。我現在想把會議交給我們今天的第一位發言人，高級副總裁兼投資者關係主管 Ran Meir。

Thank you, Nadia. Thank you, everyone, for joining us today to discuss Teva's third quarter 2022 financial results. We hope you 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，納迪亞。感謝大家今天加入我們討論 Teva 2022 年第三季度的財務業績。我們希望您有機會閱讀我們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的副本。

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 上的前瞻性聲明。有關這些聲明和我們的非 GAAP 財務指標的更多信息可在我們的收益發布以及我們的 SEC 10-K 和 10-Q 表格中找到。

To begin today's call, Kare Schultz, Teva's CEO, will provide an overview of the first quarter performance, recent events and priorities going forward. Our CFO, Eli Kalif, will follow up by reviewing the financial results in more detail. including our 2022 financial outlook. Joining Kare and Eli on the call today is Sven Dethlefs, Teva's Head of North America Business, who will be available during the question-and-answer session that will follow the presentation.

在今天的電話會議開始時，Teva 的首席執行官 Kare Schultz 將概述第一季度的業績、近期事件和未來的優先事項。我們的首席財務官 Eli Kalif 將通過更詳細地審查財務結果來跟進。包括我們的 2022 年財務展望。今天與 Kare 和 Eli 一起參加電話會議的是 Teva 的北美業務主管 Sven Dethlefs，他將在演講後的問答環節中出席。

Please note that today's call will run approximately 1 hour. And with that, I will now turn the call over to Kare. Kare, if you would, please?

請注意，今天的電話會議將進行大約 1 小時。有了這個，我現在將把電話轉給 Kare。 Kare，如果你願意，好嗎？

Thank you, Ran, and welcome to all of you. Let's take a look at the highlights for the third quarter. We came in with revenue of $3.6 billion, and our adjusted EBITDA came in at USD 1.1 billion. The GAAP diluted earnings per share were $0.05 and the non-GAAP diluted earnings per share were $0.59.

謝謝你，冉，歡迎大家。讓我們來看看第三季度的亮點。我們的收入為 36 億美元，調整後的 EBITDA 為 11 億美元。 GAAP 攤薄每股收益為 0.05 美元，非 GAAP 攤薄每股收益為 0.59 美元。

We did see significant headwinds on the revenues in Q3 on itself, we had a net impact of $215 million. And year-to-date, we've seen an impact of $510 million. That's, of course, compared to 2021. And just to give you an idea about how you can think about it, we have an estimated guidance on the revenue of, let's make it simple, $15 billion. Half of that is U.S. dollar sales in the U.S. more or less and half of it is non-U.S. dollar sales. And the dollar has been strengthening against nearly every currency.

我們確實看到了第三季度收入的重大阻力，我們的淨影響為 2.15 億美元。今年迄今為止，我們已經看到了 5.1 億美元的影響。當然，這是與 2021 年相比。為了讓您了解如何考慮它，我們對收入的估計指導，讓我們簡單地說，150 億美元。其中一半或多或少是在美國的美元銷售額，一半是非美元銷售額。美元兌幾乎所有貨幣都在走強。

So if you imagine, we have half the revenues, $7.5 billion, and that's strengthening, let's say, 1%, then that means that our revenues go down by USD 75 million. So each percent increase of the U.S. dollar is a $75 million reduction on our revenue. And of course, then when you get to operating profit, it's less of an effect. There's some offsetting elements. So it's roughly $20 million reduction in U.S. dollar operating profit for each percent that the dollar strengthens, just so you get an idea about it.

因此，如果您想像一下，我們有一半的收入，即 75 億美元，並且正在加強，比如說 1%，那麼這意味著我們的收入下降了 7500 萬美元。因此，美元每增加一個百分點，我們的收入就會減少 7500 萬美元。當然，當你獲得營業利潤時，它的影響就小了。有一些抵消因素。因此，美元每走強一個百分點，美元營業利潤就會減少大約 2000 萬美元，這樣你就知道了。

Free cash flow came in nicely at $685 million, and we continue to reduce our debt in accordance with our strategic aim, and we are now down to $19 billion, first time in many years that we are below $20 billion, which is really nice to see. Now the revenues are still affected by the strengthening of the dollar, and the dollar remains strong here in the beginning of the fourth quarter, so we've adjusted our guidance on revenues, but we have been able, through a lot of measures, to keep our guidance on the adjusted EBITDA, adjusted EPS and free cash flow. So we are reaffirming that guidance and Eli will talk more about that later.

自由現金流很好地達到了 6.85 億美元，我們繼續按照我們的戰略目標減少債務，我們現在已經下降到 190 億美元，多年來我們第一次低於 200 億美元，這真的很高興看。現在收入仍然受到美元走強的影響，第四季度初美元在這裡仍然堅挺，所以我們調整了收入指導，但我們已經能夠通過很多措施來保持我們對調整後的 EBITDA、調整後的每股收益和自由現金流的指導。所以我們重申該指導，Eli 稍後會詳細討論。

Both AUSTEDO and AJOVY are doing very fine. We'll take a look at that in a couple of minutes. And in Europe, we've seen a good development of the business. So net of the exchange effect I just talked about, we've seen 5% growth in our generics and OTC revenue in Europe. And that's, of course, reflecting our strong position there and also some good new product launches.

AUSTEDO和AJOVY都做得很好。我們將在幾分鐘後查看。在歐洲，我們看到了業務的良好發展。因此，扣除我剛才談到的交換效應，我們在歐洲的仿製藥和 OTC 收入增長了 5%。當然，這反映了我們在那裡的強勢地位以及一些不錯的新產品發布。

We have also seen substantial progress on the nationwide opioid settlement. And in just a few minutes, I'll give you some more details on that. And then on the U.S. generic drug antitrust litigation, we have made some more settlements. These are of a lower size. So roughly around USD 1 million per 1% in the U.S. population. And lately, we have settled in Georgia and Arkansas and we expect to see more of that in the coming months.

我們還看到在全國范圍內解決阿片類藥物問題取得了實質性進展。在短短幾分鐘內，我將為您提供更多詳細信息。然後在美國的仿製藥反壟斷訴訟上，我們又做了一些和解。這些尺寸較小。因此，在美國人口中，每 1% 的人大約需要 100 萬美元。最近，我們在佐治亞州和阿肯色州定居下來，我們預計在未來幾個月內會看到更多這樣的地方。

So let's move on to the opioid litigation updates. So as you remember, we have reached an agreement in principle some months ago, and we've accrued for that in our half year earnings, so that's really unchanged. We still have that accrual, and we've been having a lot of progress on that. So in the coming period, we expect to initiate the actual process of having the opt-ins and opt-outs and so on, on both the State level and on the subdivision level.

因此，讓我們繼續討論阿片類藥物訴訟更新。所以你還記得，幾個月前我們原則上達成了協議，我們已經在半年收益中計入了這一點，所以這真的沒有改變。我們仍然有應計收入，並且我們在這方面取得了很大進展。因此，在未來一段時間內，我們希望在州一級和細分級別啟動選擇加入和選擇退出等的實際過程。

We have also completed the details of our agreement with Allergan, and that was already part of the overall accrual that we did at the half year, but that's now sort of been done in details crossing the t's and dotting the i's. We have also, as you might have seen, concluded a settlement with New York, which ends the litigation in New York. And it's done in the way that New York basically signs on to the national agreement, which has a certain value. And then they also get what you call a trial bump because they have a verdict against us. They get some extra money.

我們還完成了與艾爾建 (Allergan) 達成的協議的細節，這已經是我們在半年內所做的整體應計費用的一部分，但現在已經完成了跨越 t 和點綴 i 的細節。正如您可能已經看到的那樣，我們還與紐約達成和解，結束了在紐約的訴訟。而且它是以紐約基本上簽署具有一定價值的國家協議的方式完成的。然後他們也得到了你所說的審判衝擊，因為他們對我們做出了判決。他們得到一些額外的錢。

And what's important for us is, of course, that the national agreement is what we already had accrued for. We had also accrued for the premium for New York, most of it, and we now have an arrangement where the extra money they get, they get it over 18 years, which is good for us because it means that it's very manageable in relation to our cash flow and our debt situation. So we are quite satisfied with that outcome.

對我們來說重要的是，當然，國家協議是我們已經積累的。我們還為紐約積累了大部分的保費，我們現在有一個安排，他們得到額外的錢，他們在 18 年內得到，這對我們有好處，因為這意味著它非常易於管理我們的現金流和我們的債務狀況。所以我們對這個結果非常滿意。

And then as I said, we are looking into that in the coming period, at some point in time, we'll have to go through in the normal process of states opting in and then the subdivisions opting in to the nationwide agreement. And we are quite optimistic that we will get a very, very high number of states and subdivisions joining. And in that way, we will put the majority of opioid litigation behind us to the benefit, hopefully, of the U.S. people and also good for us as a company so that we can focus on the future.

然後正如我所說，我們正在研究在接下來的一段時間內，在某個時間點，我們將必須經歷各州選擇加入的正常過程，然後各部門選擇加入全國性協議。我們非常樂觀地認為，會有非常非常多的州和分區加入。通過這種方式，我們將把大部分阿片類藥物訴訟拋在腦後，希望對美國人民有利，對我們公司也有好處，這樣我們就可以專注於未來。

Now talking about the future, let's look at the current situation on revenue and how it's been developing. And I'd like to just point to the latest chart here -- the latest bar here. You can see that it's roughly $3.6 billion, as we just talked about, and if you had the $215 million that we lost on exchange rates, you see it sort of gets to the $3.8 billion range, which is very similar to where it's been sort of up and down over the last many quarters. So the main change here is really that we have seen this appreciation of the U.S. dollar. Other than that, we have a very stable business in all the different areas of our business.

現在談論未來，讓我們看看收入的現狀及其發展情況。我只想指出這裡的最新圖表——這裡的最新柱狀圖。你可以看到它大約是 36 億美元，正如我們剛才談到的，如果你有我們在匯率上損失的 2.15 億美元，你會看到它有點達到 38 億美元的範圍，這與它的排序非常相似在過去的幾個季度中上下波動。所以這裡的主要變化實際上是我們看到了美元的升值。除此之外，我們在業務的所有不同領域都有非常穩定的業務。

But let me just comment on our 2 key products, AUSTEDO first. So you will see here that AUSTEDO grew 30% versus last year to $260 million, and we see a very strong development continue on AUSTEDO with nice increase in both revenues and in prescriptions and also in patients and number of doctors writing the product. So all in all, it's looking very positive, and we are on track to reach around USD 1 billion in sales in 2022. So that's very positive. And of course, very nice to see more and more people being treated also for tardive dyskinesia with this nice drug.

但讓我先評論一下我們的 2 個主要產品，AUSTEDO。所以你會在這裡看到 AUSTEDO 比去年增長了 30%，達到 2.6 億美元，我們看到 AUSTEDO 繼續保持非常強勁的發展，收入和處方以及編寫該產品的患者和醫生數量都有很好的增長。所以總而言之，它看起來非常積極，我們有望在 2022 年達到約 10 億美元的銷售額。所以這是非常積極的。當然，很高興看到越來越多的人也用這種好藥治療遲發性運動障礙。

If we move to AJOVY, then we also here have a very nice positive development. You can see the scripts in the U.S., the TRx keep on growing. You can see here how the market share in Europe is nearly 33%. In U.S., it's around 25%. And as you know, we recently launched with a partner in Japan, and they are already up to 28%. So as I've said before, we have a target here that we want to get at least to ahead of the market, 33%. And I think it's fair to tell you that I've already told Europe that, that's getting too easy now. So they have a new target of 50%, which is exciting, of course, for them and me.

如果我們轉移到 AJOVY，那麼我們在這裡也有一個非常好的積極發展。你可以在美國看到腳本，TRx 不斷增長。你可以在這裡看到歐洲的市場份額接近 33%。在美國，這一比例約為 25%。如您所知，我們最近與日本的合作夥伴一起推出，他們已經高達 28%。因此，正如我之前所說，我們在這裡有一個目標，我們希望至少領先於市場 33%。而且我認為可以公平地告訴你，我已經告訴歐洲了，現在這太容易了。所以他們有一個 50% 的新目標，這對他們和我來說當然是令人興奮的。

Now if we go on to cost management, then of course, there's a lot of discussions about inflationary pressure and so on these days, and of course, we also have some inflationary pressures on things like energy and other elements of our manufacturing cost base. We are trying to compensate by being more efficient. And as you know, we've had a strong efficiency drive for the last 5 years. We're continuing that. And that is, to some extent, you could say, taking the worst out of the inflationary pressure. And here, you can see that we are year-to-date 27.3% in operating margin, and we are very committed to and feel very secure about reaching the 28% next year, which is our 2023 end-of-year target.

現在，如果我們繼續進行成本管理，那麼這些天當然有很多關於通脹壓力等的討論，當然，我們在能源和製造成本基礎的其他要素方面也存在一些通脹壓力。我們正試圖通過提高效率來彌補。如您所知，在過去的 5 年裡，我們一直在大力提高效率。我們正在繼續。也就是說，在某種程度上，你可以說，從通脹壓力中剔除最壞的情況。在這裡，你可以看到我們年初至今的營業利潤率為 27.3%，我們非常致力於明年達到 28%，這是我們 2023 年年底的目標，我們對此非常有信心。

The net debt continues to decline. And just a little fun fact here. Over the last 5 years, we have paid $20 billion of cash to the bondholders. The $15 billion, that's the reduction in the debt and the $5 billion is, of course, roughly $1 billion in interest rate every year. So $20 billion out of the accounts from us to them, and we will continue to do that until we get the debt down and we get the interest rates payments down in parallel, of course.

淨債務繼續下降。這裡只是一個有趣的事實。在過去的 5 年裡，我們向債券持有人支付了 200 億美元的現金。 150 億美元是債務的減少，而 50 億美元當然是每年大約 10 億美元的利率。因此，從我們到他們的賬戶中有 200 億美元，我們將繼續這樣做，直到我們降低債務，當然，我們同時降低利率支付。

So on the pipeline, if we take a look at that, then I think I'll only comment on 1 key event, and that is that we've just refiled risperidone LAI for schizophrenia. And we are very optimistic about it. We did a complete quality check of all our clinical data. It looked good, and we refiled it with FDA and hope to be able to launch this product sometime during the first half of next year.

所以在管道上，如果我們看一下，那麼我想我只會評論一個關鍵事件，那就是我們剛剛重新提交了用於精神分裂症的利培酮 LAI。我們對此非常樂觀。我們對所有臨床數據進行了全面的質量檢查。它看起來不錯，我們向 FDA 重新提交了它，希望能夠在明年上半年的某個時候推出該產品。

If we look at another element of our business, our ESG ratings, then, of course, you all know that a lot of elements go into this environmental, social and governance ratings and all the ratings are a little different. And we've been able to improve all of these, which we're very happy about. It goes well hand-in-hand with the sustainability-linked bonds, where we did the $5 billion refinancing a year ago. So we're happy to see this continued improvement. Some of the scales are where you want to have a higher number, others you want to have a low number. But I can tell you that all of these 5 important ESG ratings have been improved during the last 12 months.

如果我們看看我們業務的另一個要素，我們的 ESG 評級，那麼，當然，你們都知道很多要素都包含在環境、社會和治理評級中，而且所有評級都略有不同。我們已經能夠改進所有這些，對此我們感到非常高興。它與可持續發展相關債券密切相關，我們在一年前進行了 50 億美元的再融資。所以我們很高興看到這種持續的改進。有些天平是你想要更高數字的地方，其他你想要更低數字的地方。但我可以告訴你，這 5 個重要的 ESG 評級在過去 12 個月內都得到了改善。

To reiterate our long-term financial targets that we communicated a quarter ago, we have 4 targets. One is the operating income margin. We want to keep on driving it up and get to 30% in 2027. We need, of course, to keep on driving debt down. You just saw that it's also on a steady track there. We need to get to around 2x net debt-to-EBITDA in 2027, and we will do that. The cash earnings, of course, have to stay around 80% in order to be able to get the debt down.

為了重申我們在一個季度前傳達的長期財務目標，我們有 4 個目標。一是營業利潤率。我們希望繼續推動它，並在 2027 年達到 30%。當然，我們需要繼續推動債務下降。你剛剛看到它在那裡也處於穩定的軌道上。我們需要在 2027 年達到約 2 倍的淨債務與 EBITDA 比，我們會做到這一點。當然，現金收入必須保持在 80% 左右，才能減少債務。

And then we are committed to revenue growth and that basically means that we will do it in a combination of organic revenue growth and selected project or product in-licensing to secure that we see revenues going forward. We are committed to utilizing the cash flow to pay down debt and we do not plan to raise equity.

然後我們致力於收入增長，這基本上意味著我們將結合有機收入增長和選定的項目或產品許可來實現這一目標，以確保我們看到未來的收入。我們致力於利用現金流來償還債務，我們不打算籌集股本。

So with that, I'll hand over to Eli Kalif.

因此，我將交給 Eli Kalif。

Thank you, Kare, and good morning and good afternoon to everyone. I will begin my review of the third quarter of 2022 financial results on Slide 15, starting with our GAAP performance.

謝謝 Kare，大家早上好，下午好。我將從幻燈片 15 開始審查 2022 年第三季度的財務業績，首先是我們的 GAAP 業績。

Revenues in the third quarter of 2022 were $3.6 billion, representing a decrease of 8% or 2% in local currency terms compared to the third quarter of 2021. The decrease in revenues was mainly driven by foreign exchange headwinds in both of our European and international markets businesses. In North America, a strong uplift of AUSTEDO partially compensated a decrease in revenues in our generics business, COPAXONE and BENDEKA and TREANDA.

2022 年第三季度的收入為 36 億美元，與 2021 年第三季度相比按當地貨幣計算下降 8% 或 2%。收入下降主要是由於我們歐洲和國際市場的外匯逆風所致市場業務。在北美，AUSTEDO 的強勁增長部分彌補了我們仿製藥業務 COPAXONE 和 BENDEKA 以及 TREANDA 的收入下降。

In Q3 2022, we recorded a GAAP operating income of $419 million compared to $623 million in Q3 2021. GAAP net income of $56 million compared to $292 million in Q3 2021 and a GAAP earnings per share of $0.05 compared to $0.26 in the same period a year ago. The year-over-year decline of a GAAP operating income, net income and earnings per share was mainly driven by higher legal settlements and loss contingencies as well as lower gross profit and was partially offset by lower operating expenses.

2022 年第三季度，我們的 GAAP 營業收入為 4.19 億美元，而 2021 年第三季度為 6.23 億美元。GAAP 淨收入為 5600 萬美元，而 2021 年第三季度為 2.92 億美元，GAAP 每股收益為 0.05 美元，而同期為 0.26 美元一年前。 GAAP 營業收入、淨收入和每股收益的同比下降主要是由於較高的法律和解和損失或有費用以及較低的毛利，部分被較低的營業費用所抵消。

In recent months, the global economy has been impacted by fluctuating foreign exchange rates. Approximately 47% of our revenues are denominated in currencies other than U.S. dollars. The strengthening of the U.S. dollar versus other currencies in which we operated negatively impacted our revenues, results of operations, profit and cash flows. As Kare discussed earlier, the continued strengthening of the U.S. dollar versus other currencies during the third quarter of 2022, net hedging effect negatively impacted revenues and GAAP operating income by $215 million and $53 million, respectively, compared to the third quarter of 2021.

近幾個月來，全球經濟受到匯率波動的影響。我們大約 47% 的收入以美元以外的貨幣計價。美元兌我們經營的其他貨幣走強對我們的收入、經營業績、利潤和現金流產生了負面影響。正如 Kare 之前所討論的那樣，與 2021 年第三季度相比，2022 年第三季度美元兌其他貨幣的持續走強、淨對沖效應對收入和 GAAP 營業收入分別產生了 2.15 億美元和 5300 萬美元的負面影響。

On a year-to-date basis, we saw the same trend regarding U.S. dollar appreciation, which net of hedging effect negatively impacted revenues by $510 million compared to the first 9 months of 2021. And that was a result of the impact of a stronger U.S. dollar, especially versus the euro. I will further discuss the macroeconomic environment as part of a non-GAAP financial outlook review.

從年初至今，我們看到了美元升值的相同趨勢，與 2021 年前 9 個月相比，扣除對沖效應對收入產生了 5.1 億美元的負面影響。這是由於更強勁的影響美元，尤其是兌歐元。作為非 GAAP 財務展望審查的一部分，我將進一步討論宏觀經濟環境。

Turning to Slide 16. You can see that net non-GAAP adjustment in the third quarter of 2022 were $602 million versus $360 million in Q3 2021. We recorded a legal settlement and loss contingencies of $195 million. This was mainly related to an update of the estimated settlement provision recorded in connection with the remaining opioid cases as well as an estimated provision recorded for the claims brought by Attorney Generals representing states and territories throughout the U.S. in the generic drug antitrust litigation. Additional notable non-GAAP adjustments include amortization of purchased intangible assets totaling $165 million, the majority of which is included in the cost of goods sold.

轉到幻燈片 16。您可以看到 2022 年第三季度的淨非 GAAP 調整為 6.02 億美元，而 2021 年第三季度為 3.6 億美元。我們記錄了 1.95 億美元的法律和解和損失或有費用。這主要與更新與剩餘阿片類藥物案件相關的估計和解條款以及代表美國各州和地區的總檢察長在仿製藥反壟斷訴訟中提出的索賠的估計條款記錄有關。其他值得注意的非 GAAP 調整包括總額為 1.65 億美元的已購無形資產攤銷，其中大部分計入已售商品成本。

Moving to Slide 17 for review of our non-GAAP performance. I've already discussed our third quarter revenues, which totaled approximately $3.6 billion. Now let's move down the P&L and look at the margins. Our non-GAAP gross profit margin was 53% compared to 53.6% in Q3 2021. The decrease in non-GAAP gross profit margin was mainly driven by macroeconomic headwinds affecting our operation costs as well as lower revenue from COPAXONE, partially offset by higher revenue from AUSTEDO and a favorable mix of generic products in our Europe segment. Our non-GAAP operating margin improved to 27.2% versus 26.8% in Q3 2021. This increase was driven mainly by lower spend base, which I will discuss in the next slide. We ended the quarter with a non-GAAP earnings per share of $0.59, flat compared to Q3 2021.

轉到幻燈片 17 以審查我們的非 GAAP 業績。我已經討論了我們第三季度的收入，總計約為 36 億美元。現在讓我們向下移動損益並查看利潤率。我們的非美國通用會計準則毛利率為 53%，而 2021 年第三季度為 53.6%。非美國通用會計準則毛利率下降的主要原因是影響我們運營成本的宏觀經濟逆風以及來自 COPAXONE 的收入減少，部分被收入增加所抵消來自 AUSTEDO 的產品以及我們歐洲分部的通用產品的有利組合。我們的非 GAAP 營業利潤率從 2021 年第三季度的 26.8% 提高到 27.2%。這一增長主要是由於較低的支出基數推動的，我將在下一張幻燈片中討論這一點。本季度末，我們的非公認會計準則每股收益為 0.59 美元，與 2021 年第三季度持平。

Now let's take a look at our spend base on Slide 18. As you can see, our quarterly spend base declined by $227 million or by $70 million net of FX impact. Looking at our total spend base, on a year-to-date basis, it declined by $594 million or $212 million net of FX. We continue with our ongoing efforts to transform our global operational network and ongoing activities management of operating expenses. We continue to face a strengthening of the U.S. dollar versus other currencies as well as spend increase due to inflationary pressures as we keep focusing our efforts on reducing and optimizing our cost of goods sold. We expect the overall annual spend base to decrease to $11 billion in 2022. As I have mentioned in previous quarters, these ongoing efforts are expected to continue to help us partially mitigate the global macroeconomic headwinds, including inflation and higher cost of labor and eventually lead to stabilizing our operating margin at the level of 28% in 2023 with an ultimate goal of 30% operating margin by end of 2027.

現在讓我們來看看我們在幻燈片 18 上的支出基數。如您所見，我們的季度支出基數下降了 2.27 億美元，扣除外匯影響後下降了 7000 萬美元。看看我們的總支出基數，從年初至今，它減少了 5.94 億美元或扣除外匯後的 2.12 億美元。我們將繼續努力改變我們的全球運營網絡和運營費用的持續活動管理。由於我們一直專注於降低和優化我們的銷售成本，因此我們繼續面臨美元兌其他貨幣走強以及通脹壓力導致支出增加的問題。我們預計到 2022 年年度總支出基數將降至 110 億美元。正如我在前幾個季度提到的那樣，這些持續的努力預計將繼續幫助我們部分緩解全球宏觀經濟逆風，包括通貨膨脹和勞動力成本上升，並最終導致到 2023 年將我們的營業利潤率穩定在 28% 的水平，最終目標是到 2027 年底營業利潤率達到 30%。

Turning to free cash flow on Slide 19. Our free cash flow in the third quarter of 2022 was $685 million. As I've mentioned in the past, Teva's free cash flow tends to face headwinds at the start of the year. In addition, we faced challenges due to a timing of certain items related to our working capital as a result of operational ramp-up in relation to our annual production plan. The decrease in our free cash flow in the third quarter of 2022 compared to the third quarter of 2021 resulted mainly from changes in working capital items, primarily a lower reduction in our inventories level compared to the third quarter of 2021.

轉向幻燈片 19 上的自由現金流。我們在 2022 年第三季度的自由現金流為 6.85 億美元。正如我過去提到的那樣，Teva 的自由現金流在年初往往會遇到不利因素。此外，由於與我們的年度生產計劃相關的運營增加，與我們的營運資金相關的某些項目的時間安排，我們面臨挑戰。與 2021 年第三季度相比，我們 2022 年第三季度的自由現金流量減少主要是由於營運資金項目的變化，主要是與 2021 年第三季度相比我們的庫存水平下降幅度較小。

Today, we are reaffirming our 2022 free cash flow guidance, which we initially provided in February. Our 2022 free cash flow is expected to be in the range of $1.9 billion to $2.2 billion. We expect the free cash flow generation will pick up during the fourth quarter as we continue to drive working capital improvement. We remain on track to achieve our objective of 80% or greater free cash flow conversion by the end of 2023 as part of our ongoing long-term financial targets.

今天，我們重申我們最初在 2 月份提供的 2022 年自由現金流指導。我們 2022 年的自由現金流預計在 19 億美元至 22 億美元之間。我們預計，隨著我們繼續推動營運資本改善，第四季度自由現金流的產生將會增加。作為我們正在進行的長期財務目標的一部分，我們仍然有望在 2023 年底之前實現 80% 或更高自由現金流轉換的目標。

Turning to Slide 20. Our net debt at the end of Q3 2022 was $19 billion compared to $20.9 billion at the end of 2021. The decrease in our gross debt is related to the bond maturities paid in Q3 2022 as well as the positive effect of exchange rate fluctuation. Our net debt-to-EBITDA ratio decreased coming at 4x for Q3 2022. We expect it to further decline as we continue to make progress towards our long-term targets. Debt reduction continues to be our primary focus and main use of cash, upcoming maturities, including approximately $0.7 billion in the remainder of 2022.

轉到幻燈片 20。我們在 2022 年第三季度末的淨債務為 190 億美元，而 2021 年末為 209 億美元。我們總債務的減少與 2022 年第三季度支付的債券到期以及匯率波動。我們的淨債務與 EBITDA 比率在 2022 年第三季度下降至 4 倍。隨著我們繼續朝著長期目標取得進展，我們預計該比率將進一步下降。減少債務仍然是我們的主要重點和現金、即將到期的債務的主要用途，包括 2022 年剩餘時間內的約 7 億美元。

So now turning to our non-GAAP financial outlook for 2022 on Slide 21. I described earlier how the strengthening of the U.S. dollar versus other currencies in which we operated negatively impacts our revenue, earnings and cash flow. Additionally, high levels of inflation have recently resulted in significant economic volatility and monetary tightening by central banks. We have implemented certain measures in response to such macroeconomic pressures and are continually considering various initiatives to allow us to mitigate and offset the impact of these macroeconomic factors. The higher costs we have experienced during the recent period have already impacted our operations and will likely continue to have an effect on our financial results.

因此，現在轉向我們在幻燈片 21 上對 2022 年的非 GAAP 財務展望。我之前描述了美元兌我們運營的其他貨幣的走強如何對我們的收入、收益和現金流產生負面影響。此外，高水平的通貨膨脹最近導致嚴重的經濟波動和中央銀行的貨幣緊縮。我們已經實施了一些措施來應對這些宏觀經濟壓力，並不斷考慮各種舉措，使我們能夠減輕和抵消這些宏觀經濟因素的影響。我們在近期經歷的更高成本已經影響了我們的運營，並且可能會繼續對我們的財務業績產生影響。

At current rates, we still expect the fluctuation related to the strengthening of the U.S. dollar versus other currencies to have an unfavorable impact on revenues. And therefore, consistent with what we had communicated in July, at this time, it's prudent to adjust our guidance range for our full revenue from the previous range of $15 billion to $15.6 billion to the new range of $14.8 billion to $15.4 billion. This lowers the midpoint of our range by $200 million.

按照目前的匯率，我們仍然預計與美元兌其他貨幣走強有關的波動會對收入產生不利影響。因此，與我們在 7 月份傳達的內容一致，此時，謹慎地將我們的全部收入指導範圍從之前的 150 億美元至 156 億美元調整到 148 億美元至 154 億美元的新範圍。這將我們範圍的中點降低了 2 億美元。

We are reaffirming our full year 2022 guidance range for operating income, EBITDA, earnings per share and free cash flow. Although we were able to absorb some of the inflationary pressures this year and partly mitigated certain spend categories, we may still face volatile environment and, as such, we are keeping the broader outlook range for these items.

我們重申 2022 年全年營業收入、EBITDA、每股收益和自由現金流的指導範圍。儘管我們今年能夠吸收部分通脹壓力並部分緩解某些支出類別，但我們仍可能面臨動蕩的環境，因此，我們對這些項目保持更廣泛的展望範圍。

This concludes my review of Teva results for the third quarter of 2022. And now we will open the line for Q&A. Operator, if you will, please.

我對 Teva 2022 年第三季度業績的回顧到此結束。現在我們將開通問答熱線。接線員，如果你願意的話，請。

(Operator Instructions) We will now take the first question. It comes from the line of Elliot Wilbur from Raymond James.

（操作員說明）我們現在將回答第一個問題。它來自 Raymond James 的 Elliot Wilbur 系列。

Just first question on free cash flow and maybe just thinking a little bit about longer-term dynamics there. And just trying to incorporate the pending opioid litigation settlements and sort of think about what could potentially be a new floor on that number. We've kind of, I guess, sort of put -- I've been thinking about a floor in terms of free cash flow around $2 billion and obviously expecting somewhere north of $350 million to be paid out annually in connection with the settlement.

只是第一個關於自由現金流的問題，也許只是想一下那裡的長期動態。並且只是試圖將未決的阿片類藥物訴訟和解納入其中，並考慮一下這個數字的新底線可能是什麼。我想，我們有點——我一直在考慮自由現金流的底線在 20 億美元左右，顯然預計每年將支付 3.5 億美元以上與和解有關的費用。

But in thinking about sort of what could be the new floor over the next couple of years, I mean, is it reasonable to subtract that from sort of the lower end of the baseline number that we've been talking about for the last couple of years of $1.9 billion to $2.2 billion? Or do you still think that it's reasonable to assume that, that $2 billion floor is defensible going forward even with the litigation settlements? And then if I could just ask you to provide some more granularity or color into performance trends within the North American segment, specifically thinking about biosimilar trends and then obviously, what's happening with respect to U.S. generics because certainly, the number was quite a bit below expectations. So just trying to get a little bit more insight into the dynamics there.

但是在考慮未來幾年的新樓層時，我的意思是，從我們過去幾年一直在討論的基線數字的低端減去它是否合理年 19 億美元到 22 億美元？或者您是否仍然認為有理由假設，即使有訴訟和解，20 億美元的底價在未來也是可以辯護的？然後，如果我可以請您提供更多關於北美市場表現趨勢的詳細信息或顏色，特別是考慮生物仿製藥趨勢，然後顯然，美國仿製藥方面正在發生的事情，因為當然，這個數字要低得多期望。所以只是想更深入地了解那裡的動態。

Thanks, Elliot. So I'll give you a quick answer on the free cash flow, and then Sven will give you some more details on North America and the biosims and generics. So the free cash flow that we are expecting in the coming years is that you're talking about. So at the level of $2 billion. And that is taking into account what you also mentioned quite correctly, some place close to $350 million cash outlay through the year. And we don't see any dramatic changes to that. The whole nationwide agreement is based, as you know, on a 13-year payment schedule with equal installments. And actually, the New York settlement that we just did is partly the nationwide and partly an even longer payment schedule of the trial bump, you can call, which is over 18 years. So that's not putting additional pressure on our cash flow. But I can also just ask Eli, if you have a quick comment, and then we'll move on to Sven.

謝謝，埃利奧特。所以我會給你一個關於自由現金流的快速回答，然後 Sven 會給你更多關於北美以及生物模擬和仿製藥的細節。因此，我們預期未來幾年的自由現金流就是您所說的。所以在 20 億美元的水平上。並且考慮到您也非常正確地提到的內容，一些地方全年的現金支出接近 3.5 億美元。我們沒有看到任何顯著的變化。如您所知，整個全國性協議基於 13 年等額分期付款的付款時間表。實際上，我們剛剛達成的紐約和解部分是全國性的，部分是更長的試用期付款時間表，你可以打電話給它，超過 18 年。因此，這不會對我們的現金流造成額外壓力。但我也可以只問 Eli，如果你有一個簡短的評論，然後我們將繼續討論 Sven。

Thanks, Kare. Yes, Elliot, thanks for the questions. I think that part of our plans to reach the 80% cash conversion is also a management of working capital. So you can say that, that level that Kare mentioned around $2 billion it's a kind of a combination of our efforts to generate more cash on working capital improvements as well as from the business. So I will say that we are safely there.

謝謝，卡雷。是的，埃利奧特，謝謝你的提問。我認為我們實現 80% 現金轉換的部分計劃也是對營運資金的管理。所以你可以說，Kare 提到的大約 20 億美元的水平是我們為改善營運資本以及從業務中產生更多現金而做出的努力的結合。所以我會說我們安全地在那裡。

And then, Sven, if you comment on North America sales.

然後，斯文，如果你對北美銷售發表評論。

Yes. So for North America sales, the sales came in below our run rate or a target run rate of USD 1 billion. I think we said in the last quarter that we had a strong first half with the launch of generic Revlimid, resulting in sales above this run rate. In the second half of 2022, we do not have any significant additional launches. For that reason, the generic sales run rate is below this USD 1 billion. This will only improve in 2023 when we anticipate more launches into the U.S. generics business.

是的。因此，對於北美銷售額，銷售額低於我們的運行率或 10 億美元的目標運行率。我想我們在上個季度說過，隨著通用 Revlimid 的推出，我們在上半年表現強勁，導致銷售額高於這個運行率。 2022 年下半年，我們沒有任何重大的額外發布。因此，仿製藥的銷售運行率低於這 10 億美元。這種情況只會在 2023 年有所改善，屆時我們預計將有更多藥物進入美國仿製藥業務。

Other than this, our biosimilars sales were quite stable in Q3. We have a stable volume market share in the U.S. business that has stabilized over the last month. And on the generic price erosion level, I think also here, we see some improved rates as compared to what we've seen a year ago. It is an incremental stabilization across various product categories. We always analyze it by different product categories. And we expect this to continue in 2023. So we have on the price erosion side, I think, a stable outlook. And on the sales side, as I said, it will improve with more product launches coming into our generics business.

除此之外，我們的生物仿製藥銷售額在第三季度相當穩定。我們在美國業務中擁有穩定的銷量市場份額，上個月已經穩定下來。在一般價格侵蝕水平上，我認為也在這裡，與一年前相比，我們看到了一些改善率。它是跨各種產品類別的增量穩定。我們總是通過不同的產品類別來分析它。我們預計這種情況將在 2023 年繼續。因此，我認為，在價格下跌方面，我們的前景是穩定的。在銷售方面，正如我所說，隨著更多產品的推出進入我們的仿製藥業務，它將會有所改善。

We will now take the next question. It comes from the line of Glen Santangelo from Jefferies.

我們現在開始下一個問題。它來自 Jefferies 的 Glen Santangelo 系列。

Kare, I just wanted to talk and go back to some of your long-term targets. I think what investors are really focused on here is trying to understand the transition of the growth algorithm on the revenue side back into positive territory. And you gave a lot of detail last quarter about the 13 biosimilars in development. We didn't really talk much on this call about the biosimilar for Humira potentially coming in the middle of next year. To the previous question, you were just talking about the wave of sort of generics that are coming over next year and actually the next 4 years, I think you sort of laid out on the last call. And so I was wondering if you could maybe give us a little bit more detailed thoughts around that growth algorithm and what it will take to sort of inflect the revenues back into positive territory. And if you have any early thoughts on 2023, not that you want to give guidance or anything, but how we should think about that sort of revenue transition taking into consideration the continued headwinds from COPAXONE and the generics in North America.

Kare，我只是想談談並回到你的一些長期目標。我認為投資者真正關注的是試圖了解收入方面的增長算法向正區域的轉變。您在上個季度詳細介紹了 13 種正在開發的生物仿製藥。在這次電話會議上，我們並沒有真正談論 Humira 的生物仿製藥可能會在明年年中上市。對於上一個問題，您只是在談論明年，實際上是未來 4 年即將到來的仿製藥浪潮，我認為您在上次電話會議上已經進行了佈局。所以我想知道你是否可以給我們一些關於增長算法的更詳細的想法，以及如何使收入回到積極的領域。如果你對 2023 年有任何早期想法，不是你想提供指導或任何東西，而是我們應該如何考慮這種收入轉型，同時考慮到來自北美的 COPAXONE 和仿製藥的持續逆風。

Yes. Thanks, Glen. Good question. So let me give you a bit more details and some of it is, of course, a repeat of what I explained already a quarter ago. So if you look at the generic piece of the revenues, then first of all, we have a stable business outside the U.S., which will have single-digit positive growth. So that's Europe, that's international markets. As you know, the pricing there is quite stable. We are in the top 3 in all the European markets and also doing well in international markets. So that piece is sort of growing, you could say, low single digit, and that's very stable.

是的。謝謝，格倫。好問題。所以讓我給你更多的細節，當然，其中一些是我在一個季度前已經解釋過的內容的重複。因此，如果你看一下一般收入，那麼首先，我們在美國以外有穩定的業務，將有個位數的正增長。這就是歐洲，那就是國際市場。如您所知，那裡的定價非常穩定。我們在所有歐洲市場均排名前三，在國際市場上也表現出色。所以這件作品有點增長，你可以說，低個位數，而且非常穩定。

Then we have the U.S. marketplace where we will, in the coming years, have a substantial number of biosimilar launches. Next year, we can just mention, as you said, biosimilar Humira, potentially biosimilar Stelara. And of course, you never know exactly how it plays out. You never know how -- exactly how big a share you get. But we think we're, if not the best, then one of the best to manage the whole commercial part of a biosimilar launch. We think we've proved that with TRUXIMA, has done substantially more than $1 billion in sales already. So we think we know how to do it, and we've got the products coming in. We also have quite a number of complex generics, some we've been waiting for a while to get the FDA approvals, others are just coming on now. And we are quite optimistic about getting some of those approvals as well. So that, of course, on the generic side adds to a positive also single-digit growth on generics.

然後我們有美國市場，在未來幾年，我們將推出大量生物仿製藥。明年，正如你所說，我們可以只提到生物仿製藥 Humira，潛在的生物仿製藥 Stelara。當然，你永遠不知道結果如何。你永遠不知道如何 - 你究竟得到了多大的份額。但我們認為，即使我們不是最好的，也是管理生物仿製藥上市的整個商業部分的最佳公司之一。我們認為我們已經證明 TRUXIMA 已經實現了超過 10 億美元的銷售額。所以我們認為我們知道如何去做，並且我們已經推出了產品。我們還有很多複雜的仿製藥，有些我們已經等待了一段時間才能獲得 FDA 的批准，其他的才剛剛開始現在。我們也對獲得其中一些批准感到非常樂觀。因此，當然，在仿製藥方面也增加了仿製藥的正個位數增長。

And then the last piece is of course on the innovative products where you're absolutely right that COPAXONE will continue to decline. But as you've also just seen today, AUSTEDO and AJOVY will continue to increase. And just a little fun fact, last year, the COPAXONE that's declining was roughly equal to AUSTEDO and AJOVY that's increasing combined. So I think COPAXONE did $1 billion, the other 2 together did $1.1 billion, something like that.

然後最後一塊當然是關於創新產品，你絕對正確，COPAXONE 將繼續下降。但是正如您今天剛剛看到的那樣，AUSTEDO 和 AJOVY 將繼續增加。一個有趣的事實是，去年下降的 COPAXONE 大致等於上升的 AUSTEDO 和 AJOVY 的總和。所以我認為 COPAXONE 做了 10 億美元，其他兩個一起做了 11 億美元，類似的東西。

This year, as you've just seen in the guidance, COPAXONE will be around $700 million. The 2 others combined will be about $1.4 billion. So that shows you that now we're getting to the point where it's like instead of COPAXONE being the biggest one and then getting to be the same, about half of what AUSTEDO and AJOVY is doing, which basically means that in the coming years, that dynamic year-by-year will get better. This year, it's close to breakeven. You could say the loss on COPAXONE is the same as the gain. But in the coming years, the gains on AUSTEDO and AJOVY will be bigger than the losses on COPAXONE. Again, that will contribute to growth in the innovative medicines. And then, of course, risperidone LAI, assuming that we get that launched, which I'm very optimistic about in the first half of next year, that will also contribute to growth.

今年，正如您剛剛在指南中看到的那樣，COPAXONE 的銷售額約為 7 億美元。另外兩個加起來將達到約 14 億美元。所以這向你表明，現在我們已經到了這樣的地步，而不是 COPAXONE 成為最大的，然後變得相同，大約是 AUSTEDO 和 AJOVY 正在做的事情的一半，這基本上意味著在未來幾年，這種動態逐年會變得更好。今年，它接近收支平衡。您可以說 COPAXONE 的損失與收益相同。但未來幾年，AUSTEDO和AJOVY的收益將大於COPAXONE的損失。同樣，這將有助於創新藥物的增長。然後，當然，利培酮 LAI，假設我們在明年上半年推出它，我對此非常樂觀，這也將有助於增長。

So all in all, all these different elements are pointing in the right direction, towards what we mentioned, which is single-digit growth in 2027 on the revenue line. Thank you for the question.

所以總而言之，所有這些不同的因素都指向正確的方向，朝著我們提到的方向，即 2027 年收入線上的個位數增長。感謝你的提問。

(Operator Instructions) We will now take the next question. It comes from the line of Umer Raffat from Evercore.

（操作員說明）我們現在開始下一個問題。它來自 Evercore 的 Umer Rafat 系列。

I wanted to (inaudible) on biosimilar Humira. Do you think you need an inspection to get the approval on the upcoming BsUFA? Or do you think you can get an approval without a new FDA inspection? And can you confirm for us that the interchangeable version is the one that has the BsUFA coming up, not the one that had the CRL? And secondly, this 749 schizophrenia molecule that's now in Phase III, can you tell us a little more about what the molecule is and what you've seen in Phase I because it was not on current trials?

我想（聽不清）生物仿製藥 Humira。您認為您需要進行檢查才能獲得即將到來的 BsUFA 的批准嗎？或者你認為你可以在沒有新的 FDA 檢查的情況下獲得批准？您能否為我們確認可互換版本是即將推出 BsUFA 的版本，而不是具有 CRL 的版本？其次，現在處於 III 期的這個 749 精神分裂症分子，你能告訴我們更多關於分子是什麼的信息嗎？你在 I 期看到了什麼，因為它沒有在當前的試驗中？

Thank you very much. I will have Sven answer you on Humira and interchangeability and inspections and so on. And then I'll tell you about the antipsychotic that's going into Phase III.

非常感謝。我會讓斯文回答你關於 Humira 和互換性和檢查等問題。然後我會告訴你有關進入 III 期的抗精神病藥的信息。

The second question was on the interchangeability action dates. The action date that is coming up in December is on the interchangeability BLA. And the other question was whether there is a side reinspection necessary. So just as a reminder, the file and the FDA interactions are managed by Alvotech, not by us. And I believe Alvotech already published that they are in discussions with the FDA about the site reinspection and how it will be conducted.

第二個問題是關於互換性行動日期。 12 月即將到來的行動日期是關於可互換性 BLA。另一個問題是是否需要進行側面複檢。所以提醒一下，該文件和 FDA 的交互由 Alvotech 管理，而不是由我們管理。我相信 Alvotech 已經發布了他們正在與 FDA 討論現場重新檢查以及如何進行的問題。

Thank you, Sven. And on the 44749 that is a long-acting version of olanzapine, and it's very promising. As you know, it's the same prolongation methodology that's been used for risperidone LAI. And I'm sure you've seen the Phase III data there, which are excellent, both for once monthly and once every second month therapy.

謝謝你，斯文。而在 44749 上，它是奧氮平的長效版本，非常有前途。如您所知，這是用於利培酮 LAI 的相同延長方法。而且我相信你已經看到那裡的 III 期數據，這些數據非常好，無論是每月一次還是每兩個月一次的治療。

And as we all know, there's a big need for better long-acting therapies for schizophrenia, simply due to the fact that that's a way to secure adherence. And any relapse in schizophrenia has a potential damaging effect on the cognitive capabilities of the patients. And with olanzapine, there's been a warning for a, you could say, drowsiness syndrome, you basically fall asleep. And that's because if you take a long-acting olanzapine, then it's an intramuscular injection, that's a risk that the drug gets in your bloodstream and that you simply faint or fall asleep.

眾所周知，精神分裂症非常需要更好的長效療法，僅僅是因為這是確保依從性的一種方式。精神分裂症的任何復發都會對患者的認知能力產生潛在的破壞性影響。對於奧氮平，有一個警告，你可以說，嗜睡綜合症，你基本上會睡著。那是因為如果你服用長效奧氮平，那麼它是一種肌肉注射，藥物進入你的血液並且你只是暈倒或入睡的風險。

So for that reason, right now, you have to sit 3 hours in the doctor's office and wait after you get the injection, which means that very few people actually use it. On the other hand, we are developing a subcutaneous version here, where we think there'll be no risk of this, which means it will be a lot more convenient, easy to use for the nurse, for the doctor for the patient. So we're very excited about that.

因此，出於這個原因，現在，您必須在醫生辦公室坐 3 個小時，在註射後等待，這意味著很少有人真正使用它。另一方面，我們在這裡開發皮下版本，我們認為不會有這種風險，這意味著它會更方便，更易於護士、醫生和患者使用。所以我們對此感到非常興奮。

And the next question comes from the line of Jason Gerberry from Bank of America Securities.

下一個問題來自美國銀行證券公司的 Jason Gerberry。

Just a follow-up on the biosimilar Humira situation. As we think specifically about 2023, if approval does get pushed into maybe the second quarter or middle of next year, is there a risk that, from a contracting perspective, you're unable to participate in the market, specifically in 2023? Or do you see that as a dynamic process that will kind of reopen for bidding every quarter?

只是跟進生物仿製藥 Humira 的情況。當我們具體考慮 2023 年時，如果批准確實被推遲到明年第二季度或年中，從合同的角度來看，是否存在您無法參與市場的風險，特別是在 2023 年？還是您認為這是一個動態過程，每個季度都會重新開始招標？

And then just a follow-up on the rising European energy cost dynamic, how that impacts your business, could you give us a sense? I assume that most of that's going to be in your COGS line. And what proportion of your business is more exposed to these inflationary pressures? Just trying to get a sense of how to put in context your commentary about increasing efficiency to sort of mitigate those headwinds.

然後只是對歐洲能源成本動態上升的跟進，這對您的業務有何影響，您能否給我們一個感覺？我假設其中大部分將出現在您的 COGS 行中。您的企業中有多大比例更容易受到這些通脹壓力的影響？只是想了解如何將您關於提高效率的評論放在上下文中，以減輕這些不利因素。

Again, Sven will give you the outlook on biosimilar Humira and then I'll talk to you about the energy cost.

同樣，Sven 將向您介紹生物仿製藥 Humira 的前景，然後我將與您討論能源成本。

So on the biosimilar Humira, we are in talks with our customers, the 3 large PBMs and all other customers for the commercial side of the business to contract for 2023. All these preparations run according to plan. We are also preparing according to plan our marketing and sales and supply chain strategies. So that's all on track. And we are working closely with Alvotech to make everything work to be launch-ready by July 1.

因此，在生物仿製藥 Humira 上，我們正在與我們的客戶、3 家大型 PBM 和所有其他客戶進行談判，以便在 2023 年簽訂商業合同。所有這些準備工作都按計劃進行。我們還在按計劃準備我們的營銷和銷售以及供應鏈戰略。所以這一切都在軌道上。我們正在與 Alvotech 密切合作，以確保一切順利，以便在 7 月 1 日之前發布。

So in the contracting itself, of course, you only contract once you launch in July, this is how the settlement agreements with Epi have been structured. And then I don't expect that we will see in biosimilars a quarterly renewal of bids or businesses like you see on the generic side because the customer is different, its PBMs and not the big co-selling groups that you contract with. And secondly, the supply chain and how the supplies work are too, I would say, complicated to allow fast switchovers between different biosimilars. So once you are in the business, you should be, let's say, enjoying the business for a longer period like -- or as compared to generic spending that we see in the U.S. generics market.

所以在合同本身，當然，你只有在 7 月啟動後才能合同，這就是與 Epi 的和解協議的結構。然後我不希望我們在生物仿製藥中看到像你在仿製藥方面看到的那樣每季度更新一次投標或業務，因為客戶是不同的，它的 PBM 而不是你與之簽約的大型共同銷售集團。其次，我想說，供應鍊和供應的運作方式也很複雜，無法在不同的生物仿製藥之間快速切換。因此，一旦你進入這個行業，你應該，比方說，享受更長一段時間的業務 - 或者與我們在美國仿製藥市場看到的仿製藥支出相比。

Thank you, Sven. On the energy cost, and that's, as you said, specifically in Europe, that's an issue. Then let me, first of all, make it very clear that all our factories have taken precautions and done modifications to energy systems and so on, so that we can continue operating uninterrupted despite the changes in the European energy markets. We have also secured supplies of various types of energy, including the gas that we need, the oil that we need and so on. There's an inflationary effect this year, which is included in our numbers. And as you said, it's in the COGS line -- cost of goods sold line. And to some extent, that is modified by some of the hedging we do on our energy contracts next year.

謝謝你，斯文。關於能源成本，正如你所說，特別是在歐洲，這是一個問題。那麼首先讓我明確一點，我們所有的工廠都採取了預防措施，對能源系統進行了改造等等，這樣我們就可以在歐洲能源市場發生變化的情況下繼續不間斷地運營。我們還保證了各種能源的供應，包括我們需要的天然氣、我們需要的石油等等。今年有通貨膨脹效應，這已包含在我們的數字中。正如您所說，它在 COGS 行中——銷售商品成本行。在某種程度上，我們明年對能源合同進行的一些對沖會改變這種情況。

We have also made sure to contract most of our energy, of course, at somewhat higher prices. You have noticed that the prices have been coming down again over the last month or so after a peak. So we are seeing things relatively normalizing. Of course, some of the efficiency gains we are doing will be eaten up by this that has happened already this year to the extent we've been covering these increased costs and it's going to happen again next year. It's not dramatic. It's something we can manage. And as I said, from an operational point of view, we are completely safe. And from a cost point of view, we're doing our best to reduce the total impact of these increases in energy prices.

當然，我們還確保以更高的價格承包我們的大部分能源。您已經註意到價格在高峰期後的上個月左右再次下降。所以我們看到事情相對正常化。當然，我們正在做的一些效率提升將被今年已經發生的事情所吞噬，因為我們一直在彌補這些增加的成本，明年還會發生這種情況。這不是戲劇性的。這是我們可以管理的事情。正如我所說，從運營的角度來看，我們是完全安全的。從成本的角度來看，我們正在盡最大努力減少這些能源價格上漲的總體影響。

We will now take the next question. It comes from the line of Gary Nachman from BMO Capital.

我們現在開始下一個問題。它來自 BMO Capital 的 Gary Nachman 系列。

This is Denis Reznik on for Gary Nachman. Just in regards to business development, can you talk about the characteristics of potential assets you're looking at and kind of where and how they fit into the overall pipeline? And then if you can just kind of quantify and classify the current BD landscape in general. Are there many interesting assets out there worth in-licensing?

這是 Denis Reznik 代替 Gary Nachman。就業務發展而言，您能否談談您正在尋找的潛在資產的特徵以及它們在何處以及如何適合整個管道？然後，如果您可以對當前的 BD 景觀進行總體量化和分類。是否有許多值得獲得許可的有趣資產？

So thanks for that question. So in the BD area, what we're really looking for is we're looking for individual products or individual projects that will fit nicely with the portfolio we have, both our R&D portfolio, which is focused on neuroscience and immunology and our commercial portfolio, which is quite broad. So we are not looking to buy companies. We don't have the money for it. We don't have the appetite for it. But we are looking to find products that will fit nicely with our commercial footprint already.

所以感謝這個問題。因此，在 BD 領域，我們真正尋找的是我們正在尋找能夠很好地適應我們現有產品組合的單個產品或單個項目，包括我們專注於神經科學和免疫學的研發產品組合以及我們的商業產品組合，範圍很廣。所以我們不打算收購公司。我們沒有錢。我們沒有胃口。但我們正在尋找能夠很好地適應我們商業足蹟的產品。

And we've done quite a number of deals. If you might have noticed, we have done deals in the biosimilar area. We just talked about the Alvotech deal. We've also done deals in Europe on biosimilar LUCENTIS recently. We've done deals with different research group on earlier projects such as MODAG, where we're looking into neuroscience and other exciting deals. So that's really what you should think about that we are looking for project or product-specific deals that can strengthen our portfolio, either in the marketplace to drive revenues shorter term or in our R&D portfolio.

我們已經完成了很多交易。如果您可能已經註意到，我們已經在生物仿製藥領域進行了交易。我們剛剛談到了 Alvotech 的交易。我們最近還在歐洲完成了生物仿製藥 LUCENTIS 的交易。我們已經與不同的研究小組就早期項目（例如 MODAG）進行了交易，我們正在研究神經科學和其他令人興奮的交易。所以這真的是你應該考慮的，我們正在尋找可以加強我們產品組合的項目或產品特定交易，無論是在市場上以推動短期收入還是在我們的研發產品組合中。

We will now take the next question. And it comes from the line of Ash Verma from UBS.

我們現在開始下一個問題。它來自瑞銀的 Ash Verma 系列。

So I have two. One is just this Alvotech partnered biosimilar products like Stelara and Eylea. Are they coming from the same facility? Is that something that needs to be resolved as well? That's first. And then the second one on AUSTEDO, so I wanted to check on the DTC since it's a very promotion-sensitive market, I know you launched a campaign in mid-2021. Has that been renewed? Or do you intend to continue DTC because this is an important drug in your portfolio? And I think your competitor is making a lot of investment on the DTC front.

所以我有兩個。一個就是 Alvotech 合作的生物仿製藥產品，如 Stelara 和 Eylea。他們來自同一個設施嗎？這也是需要解決的事情嗎？這是第一。然後是關於 AUSTEDO 的第二個，所以我想檢查 DTC，因為它是一個對促銷非常敏感的市場，我知道你在 2021 年年中發起了一場活動。那是更新了嗎？還是您打算繼續使用 DTC，因為這是您產品組合中的重要藥物？而且我認為您的競爭對手在 DTC 方面進行了大量投資。

Thank you for those 2 questions. Sven will handle both of them.

謝謝你的那兩個問題。斯文會處理他們兩個。

Yes. So the Alvotech facility or the products that you mentioned Stelara, Eylea and Humira and the others that we contracted, the drug substance is manufactured in the same facility that is also now subject to this FDA discussion on Humira. The drug product itself, the manufacturing is in several locations and with several subcontractors set up in Europe. We reviewed the setup. I think it's adequate to supply us. And we are also confident that the FDA discussion will turn out positive in the end. So that's on track.

是的。因此，Alvotech 工廠或您提到的 Stelara、Eylea 和 Humira 以及我們簽約的其他產品，原料藥是在同一工廠生產的，現在也受 FDA 關於 Humira 的討論。藥品本身，製造在幾個地方，並在歐洲設立了幾個分包商。我們審查了設置。我認為這足以供應我們。我們也相信 FDA 的討論最終會產生積極的結果。所以這是正常的。

On the question on AUSTEDO. So we did not continue our TV campaign. We had a very effective TV campaign. But in Q3, we did not continue it. We analyzed that our targets of patient activation and an expansion of our prescriber base have been achieved, and our analysis suggests that we can generate the best return of our marketing investments in our downstream, moving from patient activation to the area of sales force effectiveness, sales force deployment, the patient titration and adherence management. And that does not exclude, of course, that we would return to TV. But at the moment, we believe we get the highest return on marketing spend in downstream activities.

關於 AUSTEDO 的問題。所以我們沒有繼續我們的電視宣傳活動。我們進行了一場非常有效的電視宣傳活動。但是在第三季度，我們沒有繼續下去。我們分析了我們的患者激活目標和我們的處方者基礎擴大的目標已經實現，我們的分析表明我們可以在我們的下游產生最好的營銷投資回報，從患者激活轉向銷售人員效率領域，銷售人員部署、患者滴定和依從性管理。當然，這並不排除我們會重返電視。但目前，我們相信我們在下游活動中獲得了最高的營銷支出回報。

We will now take the next question. It comes from the line of David Amsellem from Piper Sandler.

我們現在開始下一個問題。它來自 Piper Sandler 的 David Amsellem 系列。

So I just wanted to drill down on product concentration in the North American generic business. What portion of the business comes from the EpiPen generic and also TRUXIMA. And I guess where I'm going with this is, I'm trying to get a better read on to the relative importance of those 2 products for the business. How are you thinking about the competitive landscape for TRUXIMA going forward? And then same question on EpiPen, bearing in mind that there are some companies developing some noninjectable alternative dosage forms of epinephrine, how you're thinking about that as well?

所以我只想深入了解北美仿製藥業務的產品集中度。業務的哪一部分來自 EpiPen 仿製藥和 TRUXIMA。而且我想我要去的地方是，我試圖更好地了解這兩種產品對業務的相對重要性。您如何看待 TRUXIMA 未來的競爭格局？然後關於 EpiPen 的同樣問題，請記住，有些公司正在開發一些不可注射的腎上腺素替代劑型，您是如何考慮的？

Thank you for that question. I'll pass it on to Sven.

謝謝你提出這個問題。我會把它傳遞給斯文。

Yes. Thank you for the question. So TRUXIMA and EpiPen are, of course, core anchors in our generics portfolio. I would say we have another -- if you do an ABC analysis about the sales and the gross margin that we generate in generics out of the around about 300 products that we have in North America. And then, of course, we have the Canadian business as well. We have, I believe, a healthy and very classic concentration of anchor products like TRUXIMA and EpiPen.

是的。感謝你的提問。因此，TRUXIMA 和 EpiPen 當然是我們仿製藥產品組合的核心支柱。我想說我們還有另一個——如果你對我們在北美擁有的大約 300 種產品中仿製藥產生的銷售額和毛利率進行 ABC 分析。然後，當然，我們也有加拿大業務。我相信，我們擁有健康且非常經典的主打產品，如 TRUXIMA 和 EpiPen。

We have a couple of inhaler products. So asthma products, (inaudible) products as well, and patches and complex injectables. So that's quite good, I would say, and healthy portfolio distribution, and they are very stable and resilient. And that is also one of the reasons why Teva in its pipeline for North America is committed to the development of complex generics, among them, many of them that we already discussed here; Forteo, Restasis and so forth. Because we believe that over time, you can drive a very stable and resilient generics business with these type of complex products.

我們有幾種吸入器產品。所以哮喘產品，（聽不清）產品，以及貼劑和復雜的注射劑。所以這很好，我會說，健康的投資組合分佈，它們非常穩定和有彈性。這也是 Teva 在其北美管道中致力於開發複雜仿製藥的原因之一，其中許多我們已經在這裡討論過； Forteo、Restasis 等。因為我們相信，隨著時間的推移，您可以使用這些類型的複雜產品來推動非常穩定和有彈性的仿製藥業務。

And the second question was just on the competition. Is anything expected on Epi and...

第二個問題只是關於比賽。對 Epi 有什麼期望和...

On EpiPen, I don't think that we will get a generic substitutable EpiPen, the second one, our third one into the market. I think here, the competition is more happening with the products that are 505(b)(2) developments that come with new modes of action or different convenience for the patients. So that, of course, will also find its market. But EpiPen as a brand in our generic, of course, very well established in this category as the market leaders, and everybody knows how to use them. And for that reason, we don't see a dramatic shift in market share distribution in this category.

在 EpiPen 上，我不認為我們會得到一個通用的可替代 EpiPen，第二個，我們的第三個進入市場。我認為在這裡，競爭更多地發生在 505(b)(2) 開發的產品上，這些產品具有新的作用模式或為患者提供不同的便利。這樣，當然也會找到它的市場。但是 EpiPen 作為我們仿製藥中的一個品牌，當然，在這一類別中作為市場領導者的地位非常穩固，每個人都知道如何使用它們。出於這個原因，我們沒有看到這一類別的市場份額分佈發生顯著變化。

Yes. And then on TRUXIMA, we can just say, as Sven has already alluded to, we have a stable market share. We're very happy about the performance there, and we don't expect any major upheavals in that market. So thank you for the questions.

是的。然後在 TRUXIMA 上，我們可以說，正如 Sven 已經提到的那樣，我們擁有穩定的市場份額。我們對那裡的表現感到非常高興，我們預計該市場不會出現任何重大動盪。謝謝你的問題。

There are no further questions on the phone at this time. Please continue.

目前電話中沒有其他問題。請繼續。

Thank you very much. Thank you, everyone, for listening in, and have a nice day.

非常感謝。謝謝大家收聽，祝您有美好的一天。

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

我們今天的會議到此結束。感謝您的參與。你們都可以斷開連接。