Teva Pharmaceutical Industries Ltd (TEVA) 2021 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Teva Pharmaceuticals Third Quarter 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。歡迎參加梯瓦製藥 2021 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。 （操作員說明）

I would now like to hand the conference over to your first speaker today, Kevin Mannix, Senior Vice President of Investor Relations. Please go ahead.

我現在想將會議交給您今天的第一位發言人，投資者關係高級副總裁凱文曼尼克斯。請繼續。

Thank you, Nadia, and thanks, everyone, for joining us today to discuss Teva's third quarter 2021 financial results. Joining me on today's call is Kare Schultz, Teva's Chief Executive Officer; Eli Kalif, Chief Financial Officer; and Dr. Sven Dethlefs, Teva's Head of North America Commercial. We hope you've had an opportunity to review our press release, which was issued about an hour ago. A copy of the release and the slides being presented on this call can be found on our website at www.tevapharm.com.

謝謝你，納迪亞，也謝謝大家今天加入我們討論梯瓦公司 2021 年第三季度的財務業績。 Teva 首席執行官 Kare Schultz 與我一起參加今天的電話會議。 Eli Kalif，首席財務官； Teva 北美商業主管 Sven Dethlefs 博士。我們希望您有機會查看我們大約一小時前發布的新聞稿。可以在我們的網站 www.tevapharm.com 上找到本次電話會議上展示的新聞稿和幻燈片的副本。

Please note that the discussion on today's call includes certain non-GAAP measures that is defined by the SEC. Management uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the company's operations in order to better understand its business. Further, management believes the inclusion of non-GAAP financial measures provides meaningful supplementary information and facilitates analysis by investors in evaluating the company's financial performance, results of operations and trends. A reconciliation of GAAP to non-GAAP measures is available in our earnings release and in today's presentation.

請注意，今天電話會議的討論包括美國證券交易委員會定義的某些非公認會計原則措施。管理層在內部使用 GAAP 財務指標和披露的非 GAAP 財務指標來評估和管理公司的運營，以便更好地了解其業務。此外，管理層認為，納入非公認會計原則財務指標提供了有意義的補充信息，並有助於投資者在評估公司的財務業績、經營業績和趨勢時進行分析。我們的收益發布和今天的演示文稿中提供了 GAAP 與非 GAAP 措施的對賬。

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'll now turn the call over to Teva's Chief Executive Officer, Kare Schultz. Kare, if you would, please.

有了這個，我現在將把電話轉給 Teva 的首席執行官 Kare Schultz。凱爾，如果你願意，請。

Thanks, Kevin. Welcome, everyone, and thanks for your interest in Teva.

謝謝，凱文。歡迎大家，感謝您對 Teva 的關注。

Our Q3 2021 financial highlights, we'll start focusing on our revenues. The revenues came in stable compared to last year, but with a lot of underlying dynamics, which I'll be reviewing in the following slides. Our adjusted EBITDA came in at USD 1.2 billion, also very stable compared to a year ago. GAAP diluted EPS came in at $0.26. Non-GAAP diluted EPS came in at $0.59, also very close to last year. Free cash flow came in strongly at $795 million.

我們 2021 年第三季度的財務亮點，我們將開始關注我們的收入。與去年相比，收入穩定，但有很多潛在的動態，我將在下面的幻燈片中進行審查。我們調整後的 EBITDA 為 12 億美元，與一年前相比也非常穩定。 GAAP 攤薄後每股收益為 0.26 美元。非公認會計原則攤薄後每股收益為 0.59 美元，也非常接近去年。自由現金流強勁，達到 7.95 億美元。

We continue to see debt reduction and net debt has now been reduced to $21.7 billion. Today, we also announced a $4 billion refinancing. It's a debt-neutral refinancing, and it's issuing sustainability-linked bonds, which are linked to environmental KPIs and to access KPIs. And of course, we believe that by being the leading generic company in the world, we have a special, you would say, ability to support low and middle income countries with essential medicines. And we believe that's a very strong commitment we're showing this bond offering.

我們繼續看到債務減少，淨債務現已減少至 217 億美元。今天，我們還宣布了 40 億美元的再融資。這是一種債務中性的再融資，它正在發行與可持續發展相關的債券，這些債券與環境 KPI 和獲取 KPI 相關聯。當然，我們相信，作為世界領先的仿製藥公司，我們有一種特殊的能力，你可以說，我們有能力為中低收入國家提供基本藥物支持。我們相信這是我們展示債券發行的一個非常堅定的承諾。

If we move to the next slide. And here, you can see some of the dynamics on the revenue side. I'll just highlight a few of them. If you look at North America, you can see that North American revenue is a little bit below what it was a year ago. It's basically driven by the usual aspects, you could say, which is that COPAXONE is declining, and we have AJOVY and AUSTEDO increasing. And I'll be commenting on the increase of AJOVY and AUSTEDO in the coming slides. If you look at Europe, you can see that Europe is up compared to a year ago. We have seen some fluctuations, as you know, in Europe due to the COVID-19 pandemic. So we saw lower volumes in the first and second quarter of this year. We're seeing volumes starting to pick up again here in the third quarter, and we expect volumes to continue to increase in the fourth quarter. In international markets, we're basically more or less unchanged, and that really means that the key drivers here, as I said, COPAXONE, AJOVY and AUSTEDO.

如果我們轉到下一張幻燈片。在這裡，您可以看到收入方面的一些動態。我只強調其中的幾個。如果你看看北美，你會發現北美的收入略低於一年前。它基本上是由通常的方面驅動的，你可以說，COPAXONE 在下降，而我們有 AJOVY 和 AUSTEDO 增加。我將在接下來的幻燈片中評論 AJOVY 和 AUSTEDO 的增加。如果你看看歐洲，你會發現歐洲比一年前有所上升。如您所知，由於 COVID-19 大流行，我們在歐洲看到了一些波動。因此，我們看到今年第一季度和第二季度的銷量有所下降。我們看到第三季度的交易量再次開始回升，我們預計第四季度的交易量將繼續增加。在國際市場上，我們基本上或多或少沒有變化，這實際上意味著這裡的關鍵驅動因素，正如我所說，COPAXONE、AJOVY 和 AUSTEDO。

So let's move to the next slide. Here, you can see the development for AUSTEDO in the U.S. As you can see, we have seen nice strong growth in the last 3 quarters, but you can also see that there was a COVID-related slowdown in the growth, and that was really because these patients were going to their psychiatrists. More psychiatrist offices were closed during the lockdowns, and therefore, we saw this slowdown that you see in the revenues here in the first and the second quarter.

那麼讓我們轉到下一張幻燈片。在這裡，您可以看到 AUSTEDO 在美國的發展。正如您所看到的，我們在過去 3 個季度看到了強勁的增長，但您也可以看到與 COVID 相關的增長放緩，這真的是因為這些病人要去他們的精神科醫生那裡。封鎖期間關閉了更多的精神科醫生辦公室，因此，我們看到了第一季度和第二季度的收入放緩。

We are back on a strong growth track now. If you see that both that on the total scripts to the left, and you can see it also on the revenue numbers. This is a development that we expect will continue. And of course, we are also focusing very much on patient activation and our DTC campaign to ensure that more people with tardive dyskinesia can get on therapy. We still estimate that there's around 500,000 people suffering from tardive dyskinesia in the U.S., and only a very small fraction of this patient population is currently being treated. So we are very optimistic about the future growth of AUSTEDO.

我們現在又回到了強勁的增長軌道上。如果您在左側的總腳本上看到這兩個，您也可以在收入數字上看到它。這是我們預計將繼續的發展。當然，我們也非常關注患者激活和 DTC 活動，以確保更多遲發性運動障礙患者能夠接受治療。我們仍然估計，美國約有 50 萬人患有遲發性運動障礙，而目前只有極少數患者正在接受治療。所以我們非常看好AUSTEDO未來的成長。

If we move to the next slide. And as you know, AJOVY is launched now in most of the European countries and has been launched in U.S. for several years. And with regards to AUSTEDO, we see a continued nice development in the U.S., in terms of our total scripts growing quarter-over-quarter. And we also see a very nice development on AJOVY in Europe with volumes growing steadily also quarter after quarter.

如果我們轉到下一張幻燈片。如您所知，AJOVY 現已在大多數歐洲國家推出，並已在美國推出數年。關於 AUSTEDO，我們看到美國的持續良好發展，就我們的總劇本而言，季度環比增長。我們還看到 AJOVY 在歐洲的發展非常好，銷量也逐季穩步增長。

We had an initial ambition of 25% market share in U.S. and Europe for AJOVY. We increased that ambition, I think, 1 or 2 quarters ago to 1/3 of the market, and we still believe it's very likely that we can reach 1/3 of the market. And that's basically due to the very superior long-acting profile of the drug, which means that it can be dosed both monthly and quarterly and a very good safety profile that we have.

我們最初的雄心是 AJOVY 在美國和歐洲的市場份額為 25%。我認為，我們在 1 或 2 個季度前將這一雄心壯志提高到了市場的 1/3，我們仍然認為我們很可能會達到市場的 1/3。這基本上是由於該藥物具有非常優越的長效特性，這意味著它可以按月和按季度給藥，並且我們擁有非常好的安全性。

So a strong development with AJOVY. Also, as you note, in the total sales numbers, we had a milestone in Japan, which is very positive because that's related to the actual launch of AJOVY in Japan. And that means that in the coming quarters, we will have revenues from North America, Europe and Japan, in the AJOVY numbers.

因此，AJOVY 的發展勢頭強勁。此外，正如您所注意到的，在總銷售額中，我們在日本取得了里程碑式的成果，這是非常積極的，因為這與 AJOVY 在日本的實際推出有關。這意味著在接下來的幾個季度中，我們將獲得來自北美、歐洲和日本的 AJOVY 收入。

So let's move on to the next slide. Here, we're showing you our specialty in biosimilars R&D pipeline, product pipeline. We're very happy with it. I won't go through it all. That would take too long, but let me just mention 2 interesting projects: 1 is risperidone LAI, long-acting risperidone, which has been accepted by FDA. Our file has been accepted for review. We hope to have it approved next year. This is a major new benefit for people suffering from schizophrenia in the form of a subcutaneous in [taking] long-acting risperidone. So we look forward to bringing that to the market to the benefit of people suffering from schizophrenia. We also have a new interesting license arrangement as shown here in Phase 1, anle138b.

那麼讓我們繼續看下一張幻燈片。在這裡，我們向您展示我們在生物仿製藥研發管線、產品管線方面的專長。我們對此非常滿意。我不會經歷這一切。那會太長，但我只提兩個有趣的項目：1是利培酮LAI，長效利培酮，已被FDA接受。我們的文件已被接受審查。我們希望明年能獲得批准。對於患有精神分裂症的人來說，這是一個重大的新好處，即皮下注射[服用]長效利培酮。因此，我們期待將其推向市場，造福精神分裂症患者。我們還有一個有趣的新許可安排，如第 1 階段 anle138b 所示。

And if we move to the next slide, and I'll just tell you a little bit about that. We have made a license agreement with MODAG, a German company, and it's regarding 2 compounds that are in the development for treatment of MSA in Parkinson's disease, and we're very excited about this. As you know, we have a long history in Parkinson's. We think these projects are very, very interesting, and hopefully, long term. If they turn out to work then they could also have a potential in treatment of Alzheimer's. So that's a really exciting addition to our portfolio.

如果我們轉到下一張幻燈片，我會簡單地告訴你們。我們與德國公司 MODAG 達成了一項許可協議，該協議涉及兩種正在開發中用於治療帕金森病 MSA 的化合物，我們對此感到非常興奮。如您所知，我們在帕金森氏症方面有著悠久的歷史。我們認為這些項目非常非常有趣，並且希望是長期的。如果他們最終發揮作用，那麼他們也有可能治療阿爾茨海默氏症。因此，這對我們的產品組合來說是一個非常令人興奮的補充。

Let's move to the next slide. As you know, we have a long-term target for our operating margin of 28%. And during our restructuring with the loss of COPAXONE, of course, we saw an operating margin decline, and then we turned around in 2019, and now we're growing the margin. And I'm happy to report that we are growing the margin in line with our expectations. And you see here year-to-date, Q3, it's 26.8%. And if you take the midpoint of our guidance, it's 27.5%, and we are still committed to the target at the end of 2023 of 28%.

讓我們轉到下一張幻燈片。如您所知，我們的長期目標是營業利潤率為 28%。在我們因 COPAXONE 虧損而進行的重組過程中，當然，我們看到營業利潤率下降，然後我們在 2019 年扭虧為盈，現在我們正在增加利潤率。我很高興地報告，我們正在按照我們的預期增長利潤率。你在這裡看到今年迄今為止的第三季度，它是 26.8%。如果您採用我們指導的中點，則為 27.5%，我們仍致力於在 2023 年底實現 28% 的目標。

Going to the next slide. It's actually today very close to exactly 4 years since I joined Teva. And I'm very happy to report that in those 4 years, we have reduced the debt by some close to $13 billion -- $12 billion to $13 billion. And we've actually also paid $4 billion in interest rate in those 4 years altogether. So something like close to $16 billion, $17 billion have been returned to the bondholders.

轉到下一張幻燈片。實際上，距離我加入 Teva 已經快 4 年了。我很高興地報告，在這 4 年裡，我們減少了近 130 億美元的債務——120 億到 130 億美元。實際上，我們在這 4 年中總共支付了 40 億美元的利率。因此，接近 160 億美元，170 億美元已返還給債券持有人。

And we'll continue to do that because as you can see on the next slide, we have our unchanged long-term financial targets. We want to take the net debt-to-EBITDA below 3x at the end of '23. And in order to do so, we need cash earnings to be strong, above 80%, and we need the operating income margin, as I said before, to be at 28%, so that we generate the cash needed to basically keep on reducing the debt. And we are committed to use the cash flow for debt reduction and we have no plans of raising equity.

我們將繼續這樣做，因為正如您在下一張幻燈片中看到的那樣，我們的長期財務目標沒有改變。我們希望在 23 年底將淨債務與 EBITDA 之比降至 3 倍以下。為了做到這一點，我們需要強勁的現金收益，超過 80%，而且我們需要營業利潤率達到 28%，正如我之前所說，這樣我們才能產生基本持續減少所需的現金債務。我們致力於將現金流用於減少債務，我們沒有籌集股權的計劃。

And on that note, I'll hand over to Eli Kalif.

在那張紙條上，我將交給 Eli Kalif。

Thank you, Kare, and good morning and afternoon to everyone. I will begin a review of the third quarter 2021 financial results on Slide 14.

謝謝你，Kare，大家早上好，下午好。我將在幻燈片 14 上開始審查 2021 年第三季度的財務業績。

Starting with our GAAP performance. Revenue in the third quarter of 2021 were $3.887 billion, a decrease of 2% or 3% in local currency terms compared to the third quarter of 2020. This decrease was mainly due to a lower revenue in our North America segment, mainly due to COPAXONE and generic products, partially offset by higher revenues from generics and OTC products in our Europe segment, AJOVY and AUSTEDO.

從我們的 GAAP 表現開始。 2021 年第三季度的收入為 38.87 億美元，以當地貨幣計算，較 2020 年第三季度下降 2% 或 3%。這一下降主要是由於我們北美部門的收入下降，主要是由於 COPAXONE和仿製藥產品，部分被我們歐洲部門 AJOVY 和 AUSTEDO 仿製藥和非處方藥產品的收入增加所抵消。

Our revenue continued to be affected by the ongoing impact of COVID-19 pandemic on markets and on customer talking and purchasing patterns. For the sake of year-over-year comparisons, I would like to note that Q3 2020 included generic product sales in Japan, totaling $62 million and approximately $240 million for the full year 2020.

我們的收入繼續受到 COVID-19 大流行對市場以及客戶談話和購買模式的持續影響的影響。為了進行同比比較，我想指出，2020 年第三季度包括日本的仿製藥銷售額，總額為 6200 萬美元，2020 年全年約為 2.4 億美元。

As we have previously communicated, these products were divested as of February 1, 2021, along with the manufacturing site in Japan. Foreign exchange rate movements during the third quarter of 2021, including hedging effects, positively impacted revenue by $42 million compared to the third quarter of 2020.

正如我們之前所傳達的，這些產品已於 2021 年 2 月 1 日與日本的製造基地一起被剝離。與 2020 年第三季度相比，2021 年第三季度的匯率變動（包括對沖效應）對收入產生了 4200 萬美元的積極影響。

Operating income was $623 million in Q3 2021 compared to a loss of $4.3 billion in Q3 2020. Net income was $292 million in Q3 2021 compared to a net loss of $4.3 billion in Q3 2020.

2021 年第三季度的營業收入為 6.23 億美元，而 2020 年第三季度的虧損為 43 億美元。2021 年第三季度的淨收入為 2.92 億美元，而 2020 年第三季度的淨虧損為 43 億美元。

Turning to Slide 15. You can see that net non-GAAP adjustments in the third quarter of 2021 were $360 million versus approximately $5 billion in Q3 2020. You will recall that the operating loss and net loss in Q3 2020 were mainly due to a goodwill impairment charge and higher intangible asset impairment, which were related to our North American reporting unit.

轉到幻燈片 15。您可以看到 2021 年第三季度的非公認會計原則淨調整為 3.6 億美元，而 2020 年第三季度約為 50 億美元。您會記得，2020 年第三季度的經營虧損和淨虧損主要是由於商譽減值費用和更高的無形資產減值，這與我們的北美報告單位有關。

Non-GAAP net income and non-GAAP earnings per share for the third quarter of 2021 were adjusted to exclude these items with the largest main amortization of purchase intangible assets totaling $199 million, the majority of which is included in cost of goods sold.

對 2021 年第三季度的非美國通用會計準則淨收入和非美國通用會計準則每股收益進行了調整，以排除購買無形資產的最大主要攤銷總額為 1.99 億美元的這些項目，其中大部分包含在銷售成本中。

Now moving to Slide 16. For the review of our non-GAAP performance, Kare and I already reviewed the third quarter revenue, which totaled approximately $3.9 billion.

現在轉到幻燈片 16。對於我們的非 GAAP 業績的審查，我和 Kare 已經審查了第三季度的收入，總額約為 39 億美元。

So let's move down the P&L and look at the margin. Year-over-year, total non-GAAP gross profit was flat and our gross profit margin improved by 53.6% compared to 52.4% in Q3 2020. The year-over-year increase in non-GAAP gross profit margin, both for the third quarter and year-to-date, were mainly driven by improved profitability due to our ongoing efforts to optimize our cost of goods sold, improved profitability from generic products resulting from the change in our product portfolio mix, mainly in our North America segment, and higher sales of AUSTEDO and AJOVY, partially offset by lower sales of COPAXONE and lower profitability from ANDA.

因此，讓我們向下移動 P&L 並查看保證金。與去年同期相比，非美國通用會計準則毛利潤總額持平，我們的毛利率從 2020 年第三季度的 52.4% 提高了 53.6%。非美國通用會計準則毛利率同比增長，均為第三本季度和年初至今，主要是由於我們不斷努力優化我們的銷售成本，提高了盈利能力，提高了通用產品的盈利能力，這是由於我們的產品組合組合的變化，主要是在我們的北美部門，以及AUSTEDO 和 AJOVY 銷售額增加，部分被 COPAXONE 銷售額下降和 ANDA 盈利能力下降所抵消。

Our non-GAAP operating margin was 26.8% versus 25.8% a year ago. The increase was driven by higher gross profit margin mentioned above. We ended the quarter with a non-GAAP earnings per share of $0.59 compared to $0.58 in Q3 2020, mostly due to a lower spend base.

我們的非公認會計準則營業利潤率為 26.8%，而一年前為 25.8%。該增長是由上述較高的毛利率推動的。我們在本季度末的非 GAAP 每股收益為 0.59 美元，而 2020 年第三季度為 0.58 美元，這主要是由於支出基數較低。

Turning to our spend base on Slide 17. We see that our quarterly spend base declined by approximately $108 million or $128 million net of FX. Looking at the year-to-date comparison, our spend has declined by $333 million or $540 million net of FX. Based on the first 9 months of the 2021 and according to our current estimation, we believe our spend base will come in at approximately $12 billion for 2021.

轉向我們在幻燈片 17 上的支出基數。我們看到我們的季度支出基數下降了約 1.08 億美元或扣除外匯後的 1.28 億美元。從年初至今的比較來看，我們的支出減少了 3.33 億美元，即扣除外匯後的 5.4 億美元。根據 2021 年的前 9 個月，根據我們目前的估計，我們相信 2021 年我們的支出基數將達到約 120 億美元。

Now turning to free cash flow on Slide 18. Teva's free cash flow in the third quarter of 2021 was $795 million, extending the sequential rebound we saw in Q2 and Q1, which generated $625 million and $59 million, respectively. Please recall our 2021 free cash flow guidance, which we first provided in February, referring in April and July and are referring today. 2021 free cash flow is expected to be in the range of $2 billion to $2.3 billion. We expect free cash flow to pick up through the end of 2021 as we keep driving optimization of our working capital with a high focus on inventory improvements.

現在轉向幻燈片 18 上的自由現金流。梯瓦（Teva）在 2021 年第三季度的自由現金流為 7.95 億美元，延續了我們在第二季度和第一季度看到的連續反彈，分別產生了 6.25 億美元和 5900 萬美元。請回想一下我們在 2 月首次提供的 2021 年自由現金流指南，指的是 4 月和 7 月，現在指的是今天。 2021 年的自由現金流預計在 20 億美元至 23 億美元之間。我們預計自由現金流將在 2021 年底前回升，因為我們將繼續推動營運資金的優化，並高度關注庫存改善。

Turning to Slide 19. I'd like to talk about our debt management. This morning, we announced the launch of 4 billion offering of seller notes, the proceeds of which we are expected to be used for refinancing existing debt, by way of tender offer that was also announced today. This is a really debt-neutral transaction, and as you know, Teva has been very clear and consistent with its long-term financial strategy, which includes commitments to deleverage.

轉到幻燈片 19。我想談談我們的債務管理。今天上午，我們宣布推出 40 億美元的賣方票據發行，預計我們將通過今天宣布的要約收購將募集資金用於現有債務的再融資。這是一筆真正的債務中性交易，如您所知，梯瓦 (Teva) 非常明確並與其長期財務戰略保持一致，其中包括去槓桿化的承諾。

We have executed on this commitment and reduced our net debt by more than $12 billion during the last 4 years, with the majority of cash generated by our operations directed to debt repayment.

我們履行了這一承諾，在過去 4 年中減少了超過 120 億美元的淨債務，我們運營產生的大部分現金用於償還債務。

Today's announcement reflects our proactive efforts to refinance our debt ahead of significant maturities just as we did in Q1 2018 and Q4 2019. With these transactions, our main goal is to align our debt maturity profile for the coming years with our core operational performance as we continue to focus on delivering our business objective and long-term financial targets. The bond offering we announced today represents a first-ever sustainability-linked bond. We intend to offer a euro and U.S. dollar denominated sustainability-linked senior notes.

今天的公告反映了我們在重大到期之前為債務再融資的積極努力，就像我們在 2018 年第一季度和 2019 年第四季度所做的那樣。通過這些交易，我們的主要目標是使未來幾年的債務到期狀況與我們的核心運營業績保持一致，因為我們繼續專注於實現我們的業務目標和長期財務目標。我們今天宣布的債券發行是有史以來第一個與可持續發展掛鉤的債券。我們打算提供以歐元和美元計價的與可持續發展相關的優先票據。

For the last several years, Teva has evolved its approach to corporate responsibility, strategically integrating ESG aspects in its core business operations. For Teva, ESG means advancing health and equity through our medicines and across our business, optimizing the footprint of our operations on the planet and dedicated ourselves to quality, ethics and transparency.

在過去的幾年裡，Teva 已經發展了其企業責任方法，將 ESG 方面戰略性地整合到其核心業務運營中。對於 Teva，ESG 意味著通過我們的藥物和整個業務促進健康和公平，優化我們在地球上的運營足跡，並致力於質量、道德和透明度。

As part of our sustainability mixed bond offering, we have set ambitious KPIs to measure our contribution to social methods through access to medicine in low- to middle-income countries by expanding regulatory submissions and product volumes, and environmental measures regarding absolute greenhouse gas emissions reduction.

作為我們可持續發展混合債券發行的一部分，我們制定了雄心勃勃的 KPI，以衡量我們通過擴大監管提交和產品數量以及有關絕對溫室氣體減排的環境措施來衡量我們通過在中低收入國家獲得藥物對社會方法的貢獻.

Our intention is to set a direct link between our corporate responsibility commitment and our funding strategy. The bond proceeds will be used for general corporate services, which we will dedicate to refinancing of existing debt maturity expected in the coming years.

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。債券收益將用於一般企業服務，我們將致力於為未來幾年預計到期的現有債務進行再融資。

On Slide 20, you can see that our net debt at the end of Q3 2021 was $21.7 billion compared to $22.7 billion at the end of Q2 2021. This decrease was mainly due to our free cash flow generation during the quarter as well as exchange rate fluctuation. Upcoming maturities include $1.2 billion next month. Our net debt-to-EBITDA continued to decline coming in 4.51x for Q3 '21, and we continue to make progress towards our 2023 targets to be under 3x by the end of last year.

在幻燈片 20 上，您可以看到我們在 2021 年第三季度末的淨債務為 217 億美元，而在 2021 年第二季度末為 227 億美元。這一減少主要是由於我們在本季度產生的自由現金流以及匯率波動。即將到期的包括下個月的 12 億美元。 21 年第三季度，我們的淨債務與 EBITDA 之比繼續下降 4.51 倍，我們繼續朝著 2023 年目標取得進展，到去年底將低於 3 倍。

I would like to end my presentation by touching on our financial outlook for 2021, which you can see here on Slide 21. Throughout the year, our revenue has continued to be negatively impacted by the ongoing COVID-19 pandemic. We have seen its impact on our markets and on customers talking and purchasing patterns.

最後，我想談談我們對 2021 年的財務展望，您可以在幻燈片 21 上看到這一點。全年，我們的收入繼續受到持續的 COVID-19 大流行的負面影響。我們已經看到它對我們的市場以及對客戶談話和購買模式的影響。

Certainly, some geographic regions, product launches and mix of products have struggled more than others to return to their pre-COVID patterns. Nor has this been more apparent than in the U.S. market for AUSTEDO. The decrease in physician visits by patients, and physician interactions by our sales personnel due to COVID-19, has resulted in less doctors diagnosing and prescribing treatment for a patient population suffering from tardive dyskinesia, which is very underpenetrated.

當然，一些地理區域、產品發布和產品組合比其他地區更難以恢復到 COVID 之前的模式。這一點在 AUSTEDO 的美國市場上也最為明顯。由於 COVID-19，患者就診次數減少，我們的銷售人員與醫生互動減少，導致醫生為患有遲發性運動障礙的患者群體診斷和開藥治療的人數減少，而遲發性運動障礙的滲透率非常低。

In July, we reduced our guidance by $100 million to $850 million for 2021. While sales were a bit lighter in Q3 than we expected, we are still pleased with what we are seeing and expected an acceleration to occur in Q4. Therefore, we are reaffirming our guidance for AUSTEDO at $850 million.

7 月，我們將 2021 年的指引減少了 1 億美元，至 8.5 億美元。雖然第三季度的銷售額比我們預期的要輕一些，但我們仍然對我們所看到的情況感到滿意，並預計第四季度會出現加速增長。因此，我們重申對 AUSTEDO 的指導為 8.5 億美元。

The same can be said for all other components of our 2021 outlook, which includes total annual revenue of $16 billion to $16.4 billion, non-GAAP operating income of $4.3 billion to $4.6 billion, non-GAAP EBITDA of $4.8 billion to $5.1 billion, earnings per share in the range of $2.50 to $2.70, and a free cash flow of $2 billion to $2.3 billion.

我們對 2021 年展望的所有其他組成部分也是如此，其中包括 160 億美元至 164 億美元的年總收入、43 億美元至 46 億美元的非公認會計準則營業收入、48 億美元至 51 億美元的非公認會計準則 EBITDA、收益每股在 2.50 美元至 2.70 美元之間，自由現金流為 20 億美元至 23 億美元。

This concludes my review of Teva results of the third quarter of 2021. We will now open the call for questions and answers.

我對梯瓦公司 2021 年第三季度業績的回顧到此結束。我們現在開始徵集問答。

Operator, will you please open the call for questions?

接線員，請您打開電話提問嗎？

(Operator Instructions) The first question comes from the line of Umer Raffat from Evercore.

（操作員說明）第一個問題來自 Evercore 的 Umer Raffat。

Kare, have the expectations for the private attorneys who seem to have been the holdup for many companies that are trying to settle, have their expectations rebased after they got the big money settlement they wanted from the bigger companies? And are they actually at the negotiating table now or not quiet?

Kare，對於那些似乎成為許多試圖和解的公司的阻礙的私人律師，他們的期望是否在他們從大公司那裡得到了他們想要的大筆資金和解後重新建立了期望？他們現在真的在談判桌上還是不安靜？

And then secondly, I'm somewhat confused about the commentary on AUSTEDO that I'm hearing. So volumes were up 8% quarter-over-quarter, sales are up 15%, and yet it tracked slightly behind versus consensus. But what it really means is, in 4Q, it would have to track at like a 50% jump versus 3Q to get to the guidance. If you could just clarify that.

其次，我對聽到的關於 AUSTEDO 的評論有些困惑。因此，銷量環比增長 8%，銷售額增長 15%，但與共識相比略有落後。但它真正的意思是，在第四季度，它必須與第三季度相比增長 50% 才能獲得指導。如果你能澄清一下。

And then finally, on the sustainability bond, 1 of the questions I had was, isn't sustainability bond proceeds supposed to be specific to sustainability projects? Or could they also be used towards refinancing upcoming debt?

最後，關於可持續發展債券，我提出的一個問題是，可持續發展債券收益不應該專門用於可持續發展項目嗎？或者它們也可以用於為即將到來的債務再融資？

Thank you, Umer. I will take the first and the last question, and then Sven, the Head of North America, will take the AUSTEDO question.

謝謝你，烏默爾。我將回答第一個和最後一個問題，然後北美負責人 Sven 將回答 AUSTEDO 問題。

So with regards to the opioid settlement discussions, we are in active discussions with the state AGs and with the plaintiff lawyers. I don't think there's been any rebasing or change in, you could say, the discussions. But you are right that it is, of course, very complex. There's a lot of involved parties. And we haven't reached a settlement yet, as you will have seen, apart from 1 state which we're happy about, but that's, of course, only a small fraction of the whole opioid complex.

因此，關於阿片類藥物和解討論，我們正在與州 AG 和原告律師進行積極討論。我認為討論中沒有任何變基或變化。但你是對的，它當然非常複雜。有很多相關方。正如您將看到的，我們還沒有達成和解，除了一個我們很高興的狀態，但這當然只是整個阿片類藥物複合物的一小部分。

So we are optimistic that we can still reach a settlement within the next 12 months. We have an active dialogue, and we hope to see that come into operation over the next 12 months.

因此，我們樂觀地認為，我們仍然可以在未來 12 個月內達成和解。我們進行了積極的對話，我們希望看到它在未來 12 個月內開始運作。

Then on the AUSTEDO question, I'll hand that over to Sven.

然後關於AUSTEDO 問題，我將把它交給Sven。

Yes. Thanks, Umer, for the question. So the AUSTEDO plan for 2021 is based on 2 assumptions: 1 is on psychiatrist returning to office to diagnose patients in person; and the second 1 is based on the effect of the DTC campaign, which we started in May accelerating new patient starts towards the second half of the year.

是的。謝謝 Umer 的提問。所以 2021 年的 AUSTEDO 計劃基於 2 個假設：1 是精神科醫生返回辦公室親自診斷患者；第二個 1 是基於 DTC 運動的效果，我們從 5 月開始，加速了下半年新患者的開始。

What we've seen in our new patient starts going out of Q3 and now going into Q4 is a significant separation from the baseline trends. So for that reason, we expect in Q4 to have an acceleration of sales and to end the year strong with AUSTEDO.

我們在新患者中看到的情況從第三季度開始，現在進入第四季度，與基線趨勢有很大的不同。因此，出於這個原因，我們預計第四季度的銷售將加速增長，並在今年年底與 AUSTEDO 一起強勁。

Thanks, Sven. And with regards to the bonds, Umer, you are right that something called green bonds, which are linked to: A, you would say, purpose of the bond being investments in initiatives to improve the environmental impact of your activities. That's not we're doing -- what we're doing. We're doing sustainability-linked bonds, and that's really linked, you would say, to the UN' Sustainable Development Goals. And it's where you do something where you help the world in a way that you are able to do. And because we are the leading generic company in the world, we are able to provide high-quality essential medicines to low and middle income countries, and that's what we're committing to. And at the same time, we're also committing to improving our environmental footprint by reducing emissions of greenhouse gases.

謝謝，斯文。關於債券，Umer，你說得對，一種叫做綠色債券的東西，它與： A，你會說，債券的目的是投資於改善你的活動對環境影響的舉措。那不是我們正在做的——我們正在做的事情。我們正在做與可持續發展相關的債券，你會說，這確實與聯合國的可持續發展目標相關聯。這是你做某事的地方，你以你能夠做的方式幫助世界。因為我們是世界領先的仿製藥公司，我們能夠為中低收入國家提供高質量的基本藥物，這就是我們的承諾。同時，我們還致力於通過減少溫室氣體排放來改善我們的環境足跡。

So we think that's a really strong signal to our commitment to these 2 areas, and we think we're in a unique position to improve access to essential medicines in low and middle-income countries due to our broad portfolio of these products. We are the company in the world that has the most of the essential medicines on the WHO list of essential medicines.

因此，我們認為這是我們對這兩個領域的承諾的一個非常強烈的信號，我們認為，由於我們擁有廣泛的這些產品組合，我們在改善中低收入國家基本藥物的獲取方面處於獨特的地位。我們是世界上擁有世界衛生組織基本藥物清單上最多基本藥物的公司。

So we are very happy and proud about this, and we hope that the bond issuance will be very successful and that we will, of course, be reporting on an ongoing basis how we are meeting the targets we're setting for ourselves. And of course, we are committed to them and expect to meet them in line with the commitment we're showing today.

因此，我們對此感到非常高興和自豪，我們希望債券發行將非常成功，當然，我們將持續報告我們如何實現為自己設定的目標。當然，我們對他們做出承諾，並期望按照我們今天所表現出的承諾來滿足他們。

So thanks for the question, Umer.

所以謝謝你的問題，Umer。

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。

Questions for Kare and Sven. Just specifically with respect to trends in North American generics, maybe just give us some perspective in terms of the primary contributing factors behind the sequential decline and sort of the break below the $900-million mark, which obviously has been a -- has been stable for some time. Just curious as to whether it's, you would call it, very product-specific? Is it more just accelerated erosion across the base, the absence of approval? Just some color there would be helpful.

Kare 和 Sven 的問題。就北美仿製藥的趨勢而言，也許只是給我們一些關於連續下降和跌破 9 億美元大關背後的主要因素的看法，這顯然是一個 - 一直穩定的一段時間。只是好奇它是否，你會稱之為，非常特定於產品？是不是更多的只是加速了整個基地的侵蝕，沒有批准？只是一些顏色會有幫助。

And then for Kare. Maybe just a bigger picture question in terms of thinking about the U.S. generics business as a whole. Just looking at R&D spend in the North American segment, it's annualizing somewhere around $600 million to $700 million, a little over 8% of sales. I'm assuming roughly half of that is probably pegged towards generic R&D spend. And it just seems like a very high level, considering that would be cumulatively about $1 billion over the last 3 years and just not generating any real noticeable returns.

然後是凱爾。就整個美國仿製藥業務的思考而言，這可能只是一個更大的問題。僅看看北美市場的研發支出，它的年化支出約為 6 億至 7 億美元，略高於銷售額的 8%。我假設其中大約一半可能與通用研發支出掛鉤。而且這似乎是一個非常高的水平，考慮到在過去 3 年中累計將達到約 10 億美元，而且不會產生任何真正顯著的回報。

So I'm just wondering about your thinking about the need to sort of recalibrate or rethink investments in tied to the U.S. generics business?

所以我只是想知道您是否認為需要重新調整或重新考慮與美國仿製藥業務相關的投資？

Yes. Thanks for those questions. Sven will address the first 1, and then I'll address the second 1.

是的。謝謝這些問題。 Sven 將處理第一個 1，然後我將處理第二個 1。

Yes. Thanks, Elliot. So for the U.S. generics, just as a reminder, we report North American generics, a combination of Canada biosimilars in the U.S. generics business. And there are 3 factors that influence the current sales trend. 1 is the price erosion. For our portfolio, I can say that we have a relatively stable price erosion scenario. Of course, it influenced by TRUVADA and Atripla facing more generic competition, but we have a remarkable resilience in the complex generic portfolio for that reason. Overall, our pricing environment is relatively stable.

是的。謝謝，艾略特。因此，對於美國仿製藥，作為提醒，我們報告北美仿製藥，加拿大生物仿製藥在美國仿製藥業務中的組合。影響當前銷售趨勢的因素有3個。一是價格侵蝕。對於我們的投資組合，我可以說我們有一個相對穩定的價格侵蝕情景。當然，它受到 TRUVADA 和 Atripla 的影響，面臨更多的仿製藥競爭，但出於這個原因，我們在復雜的仿製藥組合中具有非凡的彈性。總體而言，我們的定價環境相對穩定。

The second factor is volume. We're coming now to the end of our volume consolidation and network restructuring that led to basically a planned volume reduction due to portfolio consolidation. So here, we also expect, let's say, a stable environment going forward. And the most important factor, of course, for us this year is the number of product launches Here, we see for us, but also for the industry overall, there are a number of FDA approvals that we got were not on plan, and that is 1 of the factors that influences the performance for this year.

第二個因素是體積。我們現在即將結束我們的銷量整合和網絡重組，由於產品組合整合，這基本上導致了計劃中的銷量減少。所以在這裡，我們也期待，比如說，一個穩定的環境。當然，對我們來說，今年最重要的因素是產品發布的數量在這裡，我們看到，而且對於整個行業來說，我們獲得的許多 FDA 批准都沒有按計劃進行，而且是影響今年業績的因素之一。

Thanks, Sven. And with regard to the overall question on generic R&D and the generics segment in the U.S. We are fully committed to being leaders worldwide in generics, also being leaders in generics in the U.S. And our R&D spend is showing a very good return on a longer basis. We are basically aiming at an 80% target of what goes off patent, whether it's biologics or chemical indices, and we are doing our R&D to match that.

謝謝，斯文。關於仿製藥研發和美國仿製藥領域的整體問題。我們完全致力於成為全球仿製藥的領導者，同時也是美國仿製藥的領導者。我們的研發支出在更長的基礎上顯示出非常好的回報.我們的基本目標是 80% 的專利失效，無論是生物製劑還是化學指標，我們正在研發以實現這一目標。

As you know, we have more than 1,000 R&D projects combined between biosimilars and generics. The majority, of course, being in generics, and we think we have a good return on it. We are still committed to the $4 billion generics revenue on average over the coming years in the North American generics and biosimilars space. We think we can meet that.

如您所知，我們有 1,000 多個生物仿製藥和仿製藥相結合的研發項目。當然，大多數是仿製藥，我們認為我們有很好的回報。我們仍致力於未來幾年在北美仿製藥和生物仿製藥領域平均實現 40 億美元的仿製藥收入。我們認為我們可以滿足這一點。

It's correct that this quarter, we haven't seen any major launches and therefore, we had a slightly weaker quarter. It's not really due to price erosion accelerating in our case, but it is due to the fact that as you've noticed over the last years, we've had like some years ago, we had EpiPen launched. Then we had the TRUXIMA launch, and then we have the TRUVADA and Atripla launched. And we are having some launches that are waiting for regulatory approval. We are optimistic that we'll see them in the coming quarters.

正確的是，本季度我們沒有看到任何重大發布，因此我們的季度略弱。在我們的案例中，這並不是真的因為價格侵蝕加速，而是因為正如你在過去幾年中註意到的那樣，我們就像幾年前一樣，推出了 EpiPen。然後我們推出了 TRUXIMA，然後我們推出了 TRUVADA 和 Atripla。我們正在等待監管部門的批准。我們樂觀地認為我們將在未來幾個季度看到它們。

So we are very committed to the U.S. generics segment, and we don't see a structural weakening of that in the years to come. The amount that's up for grabs, so to speak, the amount of revenue that goes off patent stays unchanged, very high. So we think this is a good business, and we'll keep on doing all the necessary research to support it.

因此，我們非常致力於美國仿製藥領域，並且我們認為未來幾年不會出現結構性削弱。可以爭奪的金額，可以說，專利的收入金額保持不變，非常高。所以我們認為這是一項很好的業務，我們將繼續進行所有必要的研究來支持它。

Thanks for the questions. Let's move to the next question.

感謝您的提問。讓我們轉到下一個問題。

The next question comes from the line of Ronny Gal with Bernstein.

下一個問題來自 Ronny Gal 和 Bernstein 的觀點。

Kind of want to stay on for a little bit on the same generic business. I'm kind of looking at the increase of rituximab over the last few months, and obviously, it's been a big driver for you for 2021 over 2020. You don't have another biosimilars launch in 2022, and it seems that Rituxan erosion is -- in terms of price is large enough to impact the growth of the overall North America generic line.

有點想在同一個通用業務上呆一會兒。我有點看過去幾個月利妥昔單抗的增長，顯然，它是 2021 年超過 2020 年的一個重要驅動因素。2022 年你沒有另一個生物仿製藥上市，似乎利妥昔單抗侵蝕是——就價格而言，足以影響整個北美仿製藥線的增長。

Can you talk about some other products that you may launch in 2022 that will offset that erosion? Otherwise, it's just tough to see that generic business reaching that $4 billion in 2022. Can you talk a little bit about the ups and downs of that business?

您能否談談您可能在 2022 年推出的其他一些能夠抵消這種侵蝕的產品？否則，很難看到仿製藥業務在 2022 年達到 40 億美元。您能談談該業務的起起落落嗎？

And second, the debt that you're being offering here, Eli, can you just tell us roughly what this should be the range of interest rates that you will have in 2022 versus 2021, assuming you're able to do the (inaudible) financing? I know it's a projection at this point, but just give us a feel for where it's going.

其次，您在這裡提供的債務，Eli，您能否大致告訴我們，假設您能夠做到（聽不清），您在 2022 年與 2021 年的利率範圍應該是多少？融資？我知道此時這是一個預測，但請讓我們了解它的發展方向。

So thanks for these questions, Ronny. So Sven will answer the first 1, and Eli will answer the second 1.

所以感謝這些問題，羅尼。所以 Sven 會回答第一個 1，Eli 會回答第二個 1。

Yes. Ronny, so for 2022, we also of course have round about 30 to 40 generic product launches already lined up. Every product that we did not get approved or will not get approved this year in the U.S. generics business, naturally rolls forward into 2022, and these are the complex generics that we talked about earlier this year.

是的。羅尼，所以到 2022 年，我們當然也有大約 30 到 40 種通用產品的發布。我們今年在美國仿製藥業務中沒有獲得批准或不會獲得批准的每一種產品，自然會延續到 2022 年，這些就是我們今年早些時候談到的複雜仿製藥。

For the biosimilars space, we don't expect the product launch in 2022. And you are right, rituximab is now in a situation where we have 3 competitors, Teva, Pfizer and since January, also Engine that of course, changes the pricing environment. And we move all the strategy for TRUXIMA to value maximization for 2022.

對於生物仿製藥領域，我們預計不會在 2022 年推出產品。你是對的，利妥昔單抗現在處於我們有 3 個競爭對手的情況下，梯瓦 (Teva)、輝瑞 (Pfizer) 和自 1 月以來的發動機，這當然會改變定價環境.我們將 TRUXIMA 的所有戰略轉移到 2022 年的價值最大化。

Over to Eli, and the total finance cost that we're expecting next year.

交給 Eli，以及我們預計明年的總財務成本。

Yes. So yes -- so I would say, Ronny, if you follow the 2021 and also what we see in '22 accordingly to our estimation, we are going to keep the $1 billion in terms of finance expenses. So we don't see that 1 changing.

是的。所以是的——所以我想說，羅尼，如果你按照我們的估計遵循 2021 年以及我們在 22 年看到的情況，我們將保留 10 億美元的財務費用。所以我們看不到 1 的變化。

So thanks for these questions, Ronny. Let's move to the next question.

所以感謝這些問題，羅尼。讓我們轉到下一個問題。

The next question comes from the line of David Amsellem from Piper Sandler.

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

So regarding business development in the wake of the MODAG license agreement. I guess the question here is, given the cap structure and given the spectre of liabilities, particularly on the opioids, what can you do in terms of in-licensing and acquisitions in terms of size, in terms of stage of assets, or even acquiring a commercial-ready or a commercial stage asset? How aggressive can you be there? That's number 1.

因此，關於 MODAG 許可協議之後的業務發展。我想這裡的問題是，考慮到上限結構和負債的幽靈，特別是在阿片類藥物方面，你可以在規模、資產階段甚至收購方面的許可和收購方面做些什麼商業準備或商業階段資產？你能有多大的侵略性？那是1號。

And then just stepping back on biosimilars. Obviously, your question is what kind of footprint you'll have over time. Can you just talk to philosophically what you think pricing erosion is going to look like in some of these markets?

然後只是退回生物仿製藥。顯然，您的問題是隨著時間的推移您將擁有什麼樣的足跡。您能否從哲學上談談您認為其中一些市場的價格侵蝕會是什麼樣子？

Do you think they'll mirror what we see for complex generics? Or do you think that pricing will -- and margins will remain even more robust overtime? What are you seeing? And what do you think ultimately will happen?

你認為它們會反映我們對複雜泛型的看法嗎？或者你認為定價會 - 並且利潤率將保持更加強勁的加班？你在看什麼？你認為最終會發生什麼？

David, thanks for those 2 questions. So with regards to BD, then what we can offer is basically our expertise, our know-how, our capabilities in development and our commercial capabilities. We cannot offer a big upfront cash payments, as you correctly note. But it turns out that there's actually quite a lot of companies and research groups that are not just interested in sort of cashing out and getting a lot of cash now, but some of them are really interested in keeping, you could say, some upside by staying in the project, in the sense that they have future revenues coming in, in the form of license fees. And because we had a strong track record in areas like what we just discussed with MODAG..

大衛，感謝這兩個問題。因此，對於 BD，我們可以提供的基本上是我們的專業知識、專有技術、我們的開發能力和我們的商業能力。正如您正確指出的那樣，我們不能提供大額的預付現金。但事實證明，實際上有相當多的公司和研究小組不僅對套現和獲得大量現金感興趣，而且其中一些人真的有興趣保持，你可以說，一些上行空間留在項目中，因為他們有未來的收入，以許可費的形式。而且因為我們在我們剛剛與 MODAG 討論過的領域有著良好的業績記錄。

We have had 1 of the best Parkinson drugs ever in the form of [SLE], and we have a really solid CNS knowledge base and commercial footprint. That makes us attractive. And some of the big pharma guys, they sometimes prefer to pay a big upfront and take nearly all the rights, and very low royalties, if it succeeds. But we can offer the opposite. You would say, lower upfront, lots of expertise, strong commercial footprint, and then, of course, we'll be paying some royalties, if it succeeds.

我們擁有 [SLE] 形式的有史以來最好的帕金森藥物之一，我們擁有非常紮實的 CNS 知識庫和商業足跡。這讓我們很有吸引力。而一些大型製藥公司，他們有時更願意支付高額預付款並獲得幾乎所有的權利，如果成功的話，特許權使用費非常低。但我們可以提供相反的結果。您會說，前期費用較低，專業知識豐富，商業足跡強大，然後，當然，如果成功，我們將支付一些版稅。

That's the same thing that goes for a lot of the generics in-licensing that we're doing and for that matter, for the biosimilar licensing that we're doing. If you look at the - Alvotech in-licensing, same idea, small upfront. We take part in commercialization or we do the whole commercialization and that gives value to the company that's out-licensing to us.

這與我們正在做的許多仿製藥許可以及就此而言，我們正在做的生物仿製藥許可相同。如果您查看 - Alvotech 許可，同樣的想法，前期小額。我們參與商業化，或者我們進行整個商業化，這為向我們提供許可的公司帶來了價值。

So we are optimistic that we can keep on doing that, and we are not going to do any deals where we put a lot of money on the table. We are totally committed to debt reduction, and we'll stay that way at least until we reach the end of '23 target of net debt-to-EBITDA being below 3x. And I can share with you personally, I'm really thinking that we should go even lower talks 2x before we could contemplate any significant cash in relationship to business development.

因此，我們樂觀地認為我們可以繼續這樣做，並且我們不會進行任何投入大量資金的交易。我們完全致力於減少債務，至少在我們達到 23 年底淨債務與 EBITDA 之比低於 3 倍的目標之前，我們將保持這種狀態。我可以親自與您分享，我真的認為在我們考慮與業務發展相關的任何重大現金之前，我們應該進行兩次更低的談判。

When it comes to biosimilars, then I'll give your my take on it and Sven can add some U.S. perspective to it.

當談到生物仿製藥時，我會給你我的看法，斯文可以添加一些美國的觀點。

Biosimilars are more complex and more expensive to develop. The regulatory hurdles, the scientific hurdles are higher. So in that sense, they are, like you said, more like complex generics rather than simple generics. And as a consequence of that, what we've seen so far is a pricing development that is, I would say, a mix between what you could expect from an old-fashioned simple generic and what you would expect from a specialty product getting more competition.

生物仿製藥更複雜，開發成本更高。監管障礙，科學障礙更高。所以從這個意義上說，就像你說的，它們更像是複雜的泛型而不是簡單的泛型。因此，到目前為止，我們所看到的是定價發展，我想說的是，您對老式簡單通用產品的期望與您對專業產品的期望之間的混合競賽。

So what you see is that biosimilars will start out with a lower discount than traditional generics, and then they will be dropping in price as small competitors enter. But classically, less competitors will enter and therefore, the competitive pressure will be somewhat less. But of course, the trend line is the same that the price will go down as more competition occurs, but the absolute levels are more attractive.

所以你看到的是，生物仿製藥一開始的折扣將低於傳統仿製藥，然後隨著小型競爭對手的進入，它們的價格會下降。但傳統上，較少的競爭對手會進入，因此競爭壓力會小一些。但當然，趨勢線是一樣的，價格會隨著競爭的加劇而下降，但絕對水平更具吸引力。

So the initial launch price has a lower discount than it has for normal simple generic and the price erosion is slower. So in that sense, I think you're right. It's more like complex generics. And if we look at some of those, then we can see that our situation, for instance, on EpiPen is an example of a complex generic situation that is more attractive than it is for, I would say, simple generics, such as TRUVADA, just to give you an example, right?

因此，初始發布價格的折扣低於普通簡單仿製藥的折扣，價格侵蝕也較慢。所以從這個意義上說，我認為你是對的。它更像是複雜的泛型。如果我們看一下其中的一些，那麼我們可以看到我們的情況，例如，在 EpiPen 上是一個複雜泛型情況的例子，它比簡單的泛型更有吸引力，比如 TRUVADA，只是給你一個例子，對吧？

So I think it's absolutely correct that the pricing development for biosimilars is more attractive.

所以我認為生物仿製藥的定價發展更具吸引力是絕對正確的。

And I don't know, Sven, if you would like to add some more details.

我不知道，Sven，您是否想添加更多細節。

Yes, I think you already summarized it nicely. So we think in 2 categories where we model our business cases for biosimilars. The main driver for value creation is the launch sequence. So I'll be first, second or third or fourth to market is actually the most important factor for generating value, and you see this in the difference between rituximab or TRUXIMA, for example, in our case, where we were first to market or fourth to market.

是的，我認為您已經很好地總結了它。因此，我們在 2 個類別中考慮為生物仿製藥的商業案例建模。價值創造的主要驅動力是啟動順序。所以我將成為第一、第二或第三或第四進入市場實際上是產生價值的最重要因素，你可以從利妥昔單抗或 TRUXIMA 之間的差異中看到這一點，例如，在我們的案例中，我們是第一個進入市場或第四上市。

In terms of price decline, we model an analogy to what we see over the last years already in Europe because the European biosimilar market is more established than the U.S. market. But it behaves, as Kare said, more like a complex generic market. So we have a stronger value creation upfront because the price decline is lower and then basically it trickles down as new competitors come into the market. But overall, we believe the tail end value of these drugs are much more significant than for normal generics.

在價格下降方面，我們模擬了過去幾年在歐洲看到的情況，因為歐洲生物仿製藥市場比美國市場更加成熟。但正如 Kare 所說，它的行為更像是一個複雜的仿製藥市場。因此，我們有更強的前期價值創造，因為價格下降幅度較小，然後隨著新競爭對手的進入市場，它基本上會逐漸下降。但總的來說，我們認為這些藥物的尾端價值比普通仿製藥要重要得多。

Thanks David for the questions. Let's move to the next question.

感謝大衛的問題。讓我們轉到下一個問題。

The next question comes from the line of Balaji Prasad from Barclays.

下一個問題來自巴克萊銀行的 Balaji Prasad。

2 for me. Just a follow-up on the biosimilar front. With last week's interchangeable designation for Bohringer Cyltezo, how does this influence your thoughts on the commercial landscape for Humira? And also with ATV02 due what are the current road blocks that are attached to getting it out to the market?

2對我來說。只是生物仿製藥方面的後續行動。上週 Bohringer Cyltezo 可互換名稱，這對您對 Humira 商業前景的看法有何影響？此外，由於 ATV02 將其推向市場，目前存在哪些障礙？

Secondly, on the free cash flow guide for 2021, you have a variation of around $300 million, a range of $500 million to $800 million for 4Q. Are there any material variables, which can have a $300 million impact with just 2 months left for the business?

其次，在 2021 年的自由現金流指南中，您有大約 3 億美元的變化，第四季度的變化範圍在 5 億美元到 8 億美元之間。是否存在任何重大變量，在僅剩 2 個月的時間內對企業產生 3 億美元的影響？

Thank you for those 2 questions, Sven will handle the first question. I'll give a top line on the cash flow, but I'm sure Eli will also comment on it.

感謝您提出這兩個問題，Sven 將處理第一個問題。我會給出現金流的頂線，但我相信 Eli 也會對此發表評論。

As on the first question, I think it was about the prospect for Humira biosimilars based on the fact that Boehringer got an interchangeability designation for their biosimilars. So we know, of course, Engine will come first, and then we have a whole range of competitors lined up for July launch. As I said before, I believe the launch sequence here will be the main value driver. Engine also started interchangeability study for the high concentration products. We don't believe that they will come on time within the interchangeability designation to market through 2023.

與第一個問題一樣，我認為這是關於 Humira 生物仿製藥的前景，基於 Boehringer 為其生物仿製藥獲得可互換性指定這一事實。所以我們知道，當然，Engine 將首先出現，然後我們有一系列競爭對手在 7 月推出。正如我之前所說，我相信這裡的發布順序將是主要的價值驅動因素。發動機也開始了高濃度產品的互換性研究。我們不相信它們會在 2023 年之前按時上市。

Our own product that we licensed from Alvotech will be interchangeable, and it will be a high concentration formulation. So we should be in a pretty good space for this product launch.

我們從 Alvotech 獲得許可的我們自己的產品將是可互換的，它將是一種高濃度配方。所以我們應該在這個產品發布的一個很好的空間。

Thanks, Sven. With regards to free cash flow. You raised the question how can it vary, let's say, $300 million. And there's actually a very simplistic answer to it, which is reflected if you go back historically and look at our cash flows that in the cash flow, you had elements of working capital that had a high influence, not just, you could say, the quarterly earnings because of course, the quarterly earnings don't typically have $300 million in uncertainty on them. But the free cash flow, you had your inventories, you have your accounts receivables, you have your accounts payables and so on.

謝謝，斯文。關於自由現金流。你提出了這個問題，比如說 3 億美元，它會如何變化。實際上有一個非常簡單的答案，如果您回顧歷史並查看我們的現金流量，就可以看出，在現金流量中，您擁有具有很大影響的營運資本元素，而不僅僅是，您可以說，當然，季度收益通常沒有 3 億美元的不確定性。但是自由現金流，你有你的存貨，你有你的應收賬款，你有你的應付賬款等等。

And just small swings on those can actually -- if they all swing in the same way, have a big impact on the cash flow. You saw it in the first quarter, where we just had negative, you could say -- negative is maybe the wrong word, but all the movements on the working capital went sort of against the free cash flow. So we had a very low free cash flow. You've seen all the quarters where all the movements on these working capital items move positive to the free cash flow.

實際上，只要它們的小幅波動——如果它們都以相同的方式波動，就會對現金流產生很大影響。您在第一季度看到了它，我們剛剛有負數，您可以說 - 負數可能是錯誤的詞，但營運資金的所有變動都與自由現金流背道而馳。所以我們的自由現金流非常低。您已經看到所有這些營運資金項目的所有變動都對自由現金流產生積極影響的季度。

So that is really the explanation overall, but I'm sure Eli can give you some more feel for the details of how much are the effects of these working capital elements on the actual free cash flow.

所以這確實是總體上的解釋，但我相信 Eli 可以讓你更多地了解這些營運資金要素對實際自由現金流的影響有多大的細節。

Thanks. Yes, Balaji, overall, I will say that in Q3, we saw more improvement in terms of how we are running our inventories related to our demand behavior. So we saw that in that area as well. We saw favorable collections that actually move according to the mix of the revenue and the shipment patterns.

謝謝。是的，巴拉吉，總的來說，我想說的是，在第三季度，我們在與需求行為相關的庫存運行方式方面看到了更多改進。所以我們在那個領域也看到了這一點。我們看到有利的系列實際上是根據收入和發貨模式的組合而變化的。

So all in all, it went nicely. And we still see above 70% of the conversion year-to-date, of course, and for the year. So that's on track.

所以總而言之，一切都很順利。當然，今年迄今為止，我們仍然看到超過 70% 的轉化率。所以這是在軌道上。

Thanks, Eli. Thanks for the questions. Let's move to the next question.

謝謝，伊萊。感謝您的提問。讓我們轉到下一個問題。

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

下一個問題來自花旗的 Navann Ty。

I have 2 follow-ups on generics and opioids. If you could discuss further the U.S. generics outlook.

我對仿製藥和阿片類藥物有 2 次跟進。如果您可以進一步討論美國仿製藥的前景。

You previously saw no material change in market conditions and volumes coming back in June. Did that change at all after the Q3 performance? And then on opioids, given how the New York trial is going, could we see the nationwide settlement in the first half '22 or more likely in the back half of next year?

您之前看到 6 月份的市場狀況和交易量沒有發生重大變化。在第三季度的表現之後，這種情況是否發生了變化？然後在阿片類藥物方面，考慮到紐約試驗的進展情況，我們能否在 22 年上半年或明年下半年看到全國范圍內的和解？

And also, can I just please ask the maturity of the new ESG bonds?

另外，請問新的 ESG 債券的到期日是多少？

Yes. Thanks for those questions, Navann. I think Sven will take the first 1. I'll take the second 1, and Eli will take the third 1.

是的。謝謝你的這些問題，納萬。我認為 Sven 會拿第一個 1。我會拿第二個 1，Eli 會拿第三個 1。

Yes. Thanks, Navann. I think the question was about U.S. generic volume development and the outlook for the business.

是的。謝謝，納萬。我認為問題是關於美國仿製藥銷量的發展和業務前景。

So let me answer this a little broader because we lost, of course, market share from 13 points to around about 8.5 points over the last 3 years since 2018. But if you analyze the volume or the underlying causes for that, that was primarily driven by management decisions to support our restructuring in the portfolio consolidation.

因此，讓我更廣泛地回答這個問題，因為自 2018 年以來的過去 3 年中，我們的市場份額當然從 13 個百分點下降到約 8.5 個百分點。但如果你分析數量或造成這種情況的根本原因，這主要是驅動的通過管理決策支持我們在投資組合整合中的重組。

So going forward, volume for us is not a high strategic value because our customers have led from basically buying product portfolios to buying individual molecules. So we try to optimize monetary level or the molecule value. And that's, of course, also driven in some occasions to volume captured. But overall, I would say, going forward, if we want to go for higher volumes in the U.S. generics business, it always needs to serve the purpose of making our network and operations more efficient, but also then, of course, to capture value because I believe volume and loan is not a strategic objective for us in the U.S. generics business.

因此，展望未來，數量對我們來說並不是一個高戰略價值，因為我們的客戶已經從基本上購買產品組合轉向購買單個分子。所以我們嘗試優化貨幣水平或分子價值。當然，這在某些情況下也推動了捕獲量。但總的來說，我想說的是，展望未來，如果我們想在美國仿製藥業務中獲得更高的銷量，它總是需要達到使我們的網絡和運營更高效的目的，當然還需要捕捉價值因為我相信數量和貸款不是我們在美國仿製藥業務的戰略目標。

Thanks, Sven. With regard to the opioid settlement discussions and the New York trial, and it's correct, we have an ongoing trial in New York. A Jury trial and that's proceeding, but it won't end in the near future. It will end sometime in the coming months. And a trial can always be a trigger for a settlement, but of course, you never know the New York trial could be the trigger for a settlement once we get close to the actual verdict. We are very positive towards reaching a settlement. We are in constant dialogue with the state AGs and with the plaintiffs.

謝謝，斯文。關於阿片類藥物和解討論和紐約審判，這是正確的，我們在紐約正在進行審判。陪審團審判正在進行中，但不會在不久的將來結束。它將在未來幾個月的某個時候結束。審判總是可以觸發和解，但當然，一旦我們接近實際判決，你永遠不會知道紐約審判可能會觸發和解。我們對達成和解非常積極。我們一直在與州總檢察長和原告進行對話。

So we are optimistic that we can reach a nation-wide settlement. I cannot tell you that it will happen in the next month. I think it's realistic that it can happen within the next 12 months, but I can't be more specific on the timing.

因此，我們樂觀地認為我們可以在全國范圍內達成和解。我不能告訴你它會在下個月發生。我認為它可以在未來 12 個月內發生是現實的，但我不能更具體地說明時間。

And then I think the last question, Eli, is about the bond offering, what the maturities, currencies and so on.

然後我認為最後一個問題，Eli，是關於債券發行、到期日、貨幣等等。

Yes. So thanks for the question, Navann. And I think that in terms of the -- what we are looking for to do, of course, we were going to look to do both euro and USD, for the euro 5 years and 8 years tenure, and for the USD 5 years and 7 years tenures. And actually, the way that we see it, we are going to make sure that we, in the coming years, enable us to use our current cash flow to support our maturities, and that will create kind of for the new issuing to get into a slotting between the years of '27 to '30.

是的。所以謝謝你的問題，納萬。我認為，就我們想要做的事情而言，當然，我們打算同時使用歐元和美元，歐元 5 年和 8 年，美元 5 年和7年任期。實際上，按照我們的看法，我們將確保在未來幾年內，我們能夠利用當前的現金流來支持我們的到期，這將為新發行的發行創造一種27 年到 30 年之間的時間間隔。

And with that 1, we're actually creating more modest, I would say, a portfolio on our maturity to allow us to be able to pay according to our free cash flow generation.

有了這個 1，我們實際上是在創建一個更適度的投資組合，我想說，一個成熟的投資組合，讓我們能夠根據我們的自由現金流產生來支付。

Thanks, Eli. And thanks Navann for the questions. Let's move to the next question.

謝謝，伊萊。並感謝納萬的問題。讓我們轉到下一個問題。

The next question comes from the line of Nathan Rich from Goldman Sachs.

下一個問題來自高盛的 Nathan Rich。

I have a few questions. First, maybe a follow-up for Sven on the -- on generic pricing in the U.S. It sounds like generally, generics pricing trends haven't changed, maybe excluding the dynamics with TRUVADA and Atripla that you mentioned.

我有幾個問題。首先，也許是 Sven 關於美國仿製藥定價的後續行動。聽起來一般來說，仿製藥定價趨勢沒有改變，可能不包括你提到的 TRUVADA 和 Atripla 的動態。

So could you maybe just kind of talk about what you saw play out in the third quarter? And then as we think about the fourth quarter, I know it's a seasonally stronger quarter, but it does seem like the guidance implies a bigger step-up in sales than what you typically see. So Eli, I don't know if you could maybe just help us think about the cadence between 3Q and 4Q this year?

那麼你能不能談談你在第三節看到的情況？然後當我們考慮第四季度時，我知道這是一個季節性更強的季度，但似乎該指導意味著銷售量比您通常看到的更大。所以 Eli，我不知道你是否可以幫助我們考慮一下今年 3Q 和 4Q 之間的節奏？

And then just lastly, if you could comment on what you've seen with respect to input cost trends, either API or labor costs? And how that's factored into your outlook?

最後，如果您可以評論一下您所看到的有關投入成本趨勢的情況，無論是 API 還是勞動力成本？以及這是如何影響您的前景的？

Thanks, Nathan. I think Sven will take the first 1, and Eli will take the second 1.

謝謝，內森。我認為 Sven 會拿第一個 1，Eli 會拿第二個 1。

Okay. Nathan, thank you for the question. Of course, we track pricing in the industry in U.S. generics and for other portfolio. So what we've seen is -- and we've seen also the number of [Sandoz], what they reported yesterday on the U.S. pricing portfolio, we don't see the same trend in our portfolio because we have a different portfolio structure than Sandoz has. For us, as you also said, TRUVADA and Atripla was the major factor in the first 2 quarters of this year. In the third quarter, we had a more stable pricing environment because this effect, of course, is leveling off.

好的。內森，謝謝你的問題。當然，我們會跟踪美國仿製藥和其他產品組合的行業定價。所以我們看到的是——我們也看到了 [Sandoz] 的數量，他們昨天報告的美國定價組合，我們在我們的投資組合中沒有看到相同的趨勢，因為我們有不同的投資組合結構比山德士的。正如您所說，對我們而言，TRUVADA 和 Atripla 是今年前兩個季度的主要因素。在第三季度，我們的定價環境更加穩定，因為這種影響當然正在趨於平穩。

The main driver for us is the ability to price and to supply complex generics because they are more resilient in the market. Going forward what we observed in terms of pricing environment are 2 factors: 1 is the stability of suppliers in inventory management, basically because inventory discontinued really sees drive or a set of price bidding. That's 1 element.

我們的主要驅動力是定價和供應複雜仿製藥的能力，因為它們在市場上更具彈性。展望未來，我們在定價環境方面觀察到的因素有兩個：1是供應商在庫存管理方面的穩定性，主要是因為停產的庫存確實看到了驅動或一組價格招標。那是1個元素。

The second 1 is the approval rates for new generics coming into segments where we already have generics. So it's basically FDA-driven, but here, we don't see any acceleration of the trend. So for that reason, going forward, we actually calculate our business for 2022 within a stable pricing environment for U.S. generics.

第二個 1 是新仿製藥進入我們已經擁有仿製藥的細分市場的批准率。所以它基本上是由 FDA 驅動的，但在這裡，我們沒有看到任何加速趨勢。因此，出於這個原因，展望未來，我們實際上是在美國仿製藥的穩定定價環境下計算 2022 年的業務。

Thanks, Sven. And Eli, will you comment on the change in revenue from third quarter to fourth quarter?

謝謝，斯文。 Eli，您能否評論一下從第三季度到第四季度的收入變化？

Yes. So Nathan, thanks for the question. So what we see actually in the main 3 areas, 1 of this 1 is the specialty portfolio, which, as we mentioned, we see Austedo accelerate. That's 1 element.

是的。所以，內森，謝謝你的問題。所以我們實際上在主要的 3 個領域中看到，其中 1 個是專業投資組合，正如我們所提到的，我們看到 Austedo 加速發展。那是1個元素。

The second element is more dynamics in our generics, which is actually including what as Sven mentioned, the comment about biosimilars. And the other stuff is in between the other 2 regions, Europe and international markets. Those actually are going to contribute to the increase from Q3 to Q4.

第二個元素是我們的仿製藥中的更多動態，這實際上包括 Sven 提到的關於生物仿製藥的評論。其他的東西在其他兩個地區，歐洲和國際市場之間。這些實際上將有助於從第三季度到第四季度的增長。

And we can also add that, as you said yourself, it is a seasonal pattern that we've seen, I think, in the last 10 years that there's always stronger demand. And just in general terms, 1 of the reasons for stronger demand in the fourth quarter historically is, of course, the fact that you have speculative buying by wholesalers because you have price increases typically around the 1st of January. That's been the tradition in the U.S. marketplace. So that also adds to this. And then of course, the holidays and inventory built up before the holidays, which we've also seen for many years.

我們還可以補充一點，正如您自己所說，我認為，在過去 10 年中，我們已經看到了一種季節性模式，需求總是更加強勁。就一般而言，歷史上第四季度需求強勁的原因之一當然是批發商進行投機性購買，因為通常在 1 月 1 日左右價格上漲。這是美國市場的傳統。所以這也增加了這一點。當然，假期和庫存在假期前積累起來，我們也已經看到了很多年。

Nathan, was there 1 more part to your question, what was that?

內森，你的問題還有 1 個部分嗎，那是什麼？

Just input costs, if you could just comment on what you've been seeing.

只需輸入成本，如果您可以評論您所看到的內容。

Yes. So I'll comment on that. So we've seen a lot of industries reporting that they are dramatically affected by input costs such as energy, raw materials, transportation and so on. And of course, we also see that but to a lesser extent, simply given the fact that most of our inputs are related to, you could say, the cost of labor, which is relatively stable, of course, to -- energy is a relatively small piece of our total cost base. We do see increase in transportation costs, but again, transportation is also a relatively small piece of our cost base.

是的。所以我會對此發表評論。因此，我們看到很多行業報告說它們受到能源、原材料、運輸等投入成本的巨大影響。當然，我們也看到，但在較小程度上，簡單地考慮到我們的大部分投入都與勞動力成本有關，當然，勞動力成本相對穩定，能源是一種在我們的總成本基礎中相對較小。我們確實看到運輸成本有所增加，但同樣，運輸也是我們成本基礎中相對較小的一部分。

So we haven't seen anything dramatic. It might be that we will, going forward, see an inflation effect on cost of labor that remains to be seen. It's really too early to predict. You can spend hours discussing that with any economist that you pick. So we'll be observing that. And of course, it's important -- if we get into a more inflationary environment, it is important that our whole generic portfolio, for instance, in the U.S., our whole OTC portfolio, and our specialty portfolio in U.S. is subject to price flexibility because we can actually increase prices on all these products.

所以我們還沒有看到任何戲劇性的東西。展望未來，我們可能會看到通脹對勞動力成本的影響還有待觀察。現在預測還為時過早。你可以花幾個小時與你選擇的任何經濟學家討論這個問題。因此，我們將對此進行觀察。當然，這很重要——如果我們進入一個更加通脹的環境，重要的是我們的整個通用投資組合，例如，在美國，我們的整個 OTC 投資組合，以及我們在美國的專業投資組合都受到價格靈活性的影響，因為我們實際上可以提高所有這些產品的價格。

So thanks for those questions, Nathan. And let's move on to the next. I think it might be the last.

所以感謝這些問題，內森。讓我們繼續下一個。我想這可能是最後一次。

So we're 2 last.

所以我們是最後一個。

Okay. 2 more questions, 2 more people. So let's have the next 1.

好的。還有2個問題，2個人。所以讓我們有下一個 1。

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

下一個問題來自美國銀行的 Jason Gerberry。

This is Ash Verma on for Jason. So 1 on opioid litigation. So can you talk about the recent Louisiana opioid settlement which has a November 2 [up to an end] for the [TA] deadline for the political subdivisions. Do you have any visibility into that process? I would imagine that, that would be informative in terms of happens with the rest of the states for the subdivision?

這是 Jason 的 Ash Verma。所以 1 關於阿片類藥物訴訟。所以你能談談最近的路易斯安那州阿片類藥物解決方案，該解決方案的 [TA] 政治分區的截止日期是 11 月 2 日 [直到結束]。您對該過程有任何了解嗎？我想，這對於細分其他州的情況會提供信息嗎？

And the second question is the risperidone LAI. So how much of a benefit does the subcu provide here?

第二個問題是利培酮LAI。那麼 subcu 在這裡提供了多少好處呢？

Sorry, could you just repeat the last question? How much exactly what does risperidone LAI provide?

對不起，你能重複最後一個問題嗎？利培酮 LAI 究竟能提供多少？

Yes. How much of a benefit does the subcutaneous formulation provide here? As we know, like 1 of the other subcu has not done well in the market.

是的。皮下製劑在這裡提供了多少好處？正如我們所知，其他 subcu 中的 1 個在市場上表現不佳。

Yes. Thank you very much. So I think I'll handle both of these. With regard to the opioids and the settlement in Louisiana, then we're very happy about this settlement. It is basically a mirror of what we are offering and seeking to reach as a nationwide settlement.

是的。非常感謝你。所以我想我會處理這兩個問題。關於阿片類藥物和路易斯安那州的定居點，那麼我們對這個定居點感到非常高興。它基本上反映了我們作為全國性定居點提供和尋求達到的目標。

So it's a pro rata cash amount paid over 18 years, the same way as we are discussing it for the nationwide settlement, and it includes also products Suboxone. And that is, of course, important because that's a product you use to win people of opioid abuse and misuse. So we're very happy about it.

所以這是 18 年內按比例支付的現金金額，與我們討論的全國結算方式相同，它還包括產品 Suboxone。當然，這很重要，因為這是您用來贏得阿片類藥物濫用和濫用的人的產品。所以我們對此感到非常高興。

Your specific question about the subdivisions. This assumes that all the subdivisions in the state of Louisiana are included, and that's been the way we've been negotiating it with the state. And we're optimistic that this will be the case. I can't remember as a deadline, I think we haven't reached it yet where we just need to get confirmation that all the subdivisions are included, but that's our clear assumption that, that will be the case. And of course, for the nationwide settlement that we are discussing, we also need the subdivisions in there because otherwise, it doesn't really make any sense. So that's what we're going for.

您關於細分的具體問題。這假設路易斯安那州的所有細分都包括在內，這就是我們與該州談判的方式。我們樂觀地認為情況會如此。我不記得最後期限了，我認為我們還沒有達到它，我們只需要確認所有細分都包括在內，但這是我們明確的假設，情況就是如此。當然，對於我們正在討論的全國性定居點，我們還需要那裡的細分，否則，它真的沒有任何意義。所以這就是我們要做的。

With regard to risperidone LAI and what the benefits are compared to the other long-acting injectables that exist in the marketplace. I need to give you just a little bit of explanation. So when you suffer from schizophrenia, it's really important that you stay on your medication. And there is a risk if you only take daily tablets that you skip some tablets because you get a little confused, you feel very well, and then all of a sudden, you get a relapse. And every time you get a really bad relapse and get psychotic, it is very harmful for your brain and your cognitive functions.

關於利培酮 LAI 以及與市場上存在的其他長效注射劑相比的好處。我需要給你一點解釋。因此，當您患有精神分裂症時，堅持服藥非常重要。如果你每天只服用片劑，你會因為有點困惑而跳過一些片劑，這是有風險的，你感覺很好，然後突然之間，你會復發。每次你出現非常嚴重的複發並患上精神病，這對你的大腦和認知功能都是非常有害的。

So therefore, it's very important that you stay on your medication, and therefore, all the long-acting products were invented initially. They are typically given intramuscular injections, kind of a depot effect. And these injections are quite painful because it's a quite new technique, so to speak, a long needle and you need to get it into the muscle tissue. So this is not a very nice thing to undergo, but it's very effective, of course, because it secures that you'll cover, for instance, [12] month.

因此，堅持服藥非常重要，因此，最初發明了所有長效產品。他們通常被肌肉注射，一種倉庫效應。這些注射是相當痛苦的，因為它是一種相當新的技術，可以說是一根長針，你需要將它插入肌肉組織。所以這不是一件非常好的事情，但它當然非常有效，因為它可以確保您將覆蓋例如 [12] 個月。

Now in the case of our product, it's a major improvement because it's subcutaneous. So it's a small volume. It is a very, very low level of pain. It's a very, very thin needle. It's easy to do the injection. And that's really the main benefit. And then we've done Phase III clinical trials, showing that both once monthly, and once every second month. We have excellent efficacy, very, very strong Phase III clinical data.

現在就我們的產品而言，這是一個重大改進，因為它是皮下的。所以體積很小。這是一種非常、非常低程度的疼痛。這是一根非常非常細的針。注射很容易。這確實是主要的好處。然後我們進行了 III 期臨床試驗，顯示每月一次和每兩個月一次。我們擁有出色的療效、非常非常強大的 III 期臨床數據。

So that's really the benefit you get the strong efficacy, but in a nice more convenient way.

所以這確實是您獲得強大功效的好處，但以一種更方便的方式。

So thanks for those questions, Ash. And now to the last questions.

所以感謝這些問題，Ash。現在到最後一個問題。

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

最後一個問題來自 BMO Capital 的 Gary Nachman。

First, Kare, where are you seeing most of the COVID-19 impact in different markets and with customer stocking and purchasing patterns. When should that normalize? Will that happen in 4Q? And are you still confident in 2021 should be a trough year, whether revenue or EBITDA?

首先，Kare，您在哪裡看到了 COVID-19 在不同市場以及客戶庫存和購買模式中的大部分影響。什麼時候應該正常化？這會在第四季度發生嗎？您是否仍然相信 2021 年應該是低谷的一年，無論是收入還是 EBITDA？

What are some of the big levers there that we should be thinking about now as we're approaching year-end?

臨近年底，我們現在應該考慮哪些重要的槓桿？

And then the second question AJOVY launch in Japan, what's the opportunity there? What are the markets will you be going into? What could the contribution from AUSTEDO be in China and other markets outside the U.S.? And how much will ex-U.S. markets contribute to your guidance targets for both AUSTEDO and AJOVY this year that you set out?

然後第二個問題 AJOVY 在日本推出，那裡的機會是什麼？你將進入哪些市場？ AUSTEDO 對中國和美國以外的其他市場有何貢獻？以及前美國將有多少市場對您制定的今年 AUSTEDO 和 AJOVY 的指導目標有貢獻嗎？

Thank you, Gary. I think I'll take the first 1. Sven can comment also on it, and then I'll take the second 1.

謝謝你，加里。我想我會拿第一個 1。Sven 也可以評論它，然後我會拿第二個 1。

So I'll do it over all high level because there's a lot of details to the COVID-19 impacts, of course. But if you think about it high level, and of course, COVID's been with us so long now that we have to go all the way back to 2020. You remember that we have a patient hoarding of products, specifically in Europe in the first quarter of 2020. Then we had a destocking at patient levels in the second quarter of 2020, which took volumes down. Then we have the effect of, you could say, the lockdowns in both U.S. and Europe in the third and fourth quarter of last year 2020. And then we were optimistic when we made the guidance for 2021, that we were seeing all the vaccinations coming on, and we hope that after Q1, then we would see basically the market normalizing in Q2 of this year.

所以我會在所有高層次上做這件事，因為當然有很多關於 COVID-19 影響的細節。但是，如果您認為它是高水平的，當然，COVID 已經與我們在一起很長時間了，以至於我們必須一直回到 2020 年。您還記得，我們有耐心地囤積產品，特別是第一季度在歐洲2020 年。然後我們在 2020 年第二季度對患者水平進行了去庫存，這導致銷量下降。然後，您可以說，美國和歐洲在 2020 年第三季度和第四季度都處於封鎖狀態。然後，當我們制定 2021 年的指導方針時，我們很樂觀，我們看到所有的疫苗接種都即將到來繼續，我們希望在第一季度之後，我們會看到今年第二季度市場基本正常化。

Now as we all know, it didn't go that fast. We did see the initial normalization of script levels in the U.S. starting at the end of the second quarter. But at that point in time, of course, we were below where we were expecting to be because we thought we would have had normal doctor visits, prescriptions and so on in Q2 of this year, and we didn't get that.

現在眾所周知，它並沒有那麼快。從第二季度末開始，我們確實看到了美國腳本級別的初始正常化。但在那個時候，當然，我們低於預期，因為我們認為在今年第二季度我們會有正常的醫生就診、處方等，但我們沒有得到。

We had the continued lockdowns, mask mandates, all this stuff happening both in Europe and U.S., high levels of infections and so on. So we got lower volumes, which I showed you before of AUSTEDO scripts, of reps visits to psychiatrists, of psychiatrists, staying open and so on. All those numbers are subdued in the second quarter.

我們有持續的封鎖、口罩強制令、所有這些都發生在歐洲和美國、高水平的感染等等。所以我們得到了較低的數量，我之前向你展示了 AUSTEDO 腳本、代表訪問精神科醫生、精神科醫生、保持開放等等。所有這些數字在第二季度都被抑制了。

In the third quarter, they've started to move up. That's why you see the AUSTEDO scripts are moving up, AUSTEDO sales are moving up. Also in Europe, the lockdowns have been more or less lifted. So we see European volume coming up, but we had hoped that European volumes started picking up already in the second quarter and then accelerated in the third and fourth quarter.

在第三季度，他們開始向上移動。這就是為什麼您會看到 AUSTEDO 腳本在上升，AUSTEDO 銷售額在上升。同樣在歐洲，封鎖或多或少已經解除。所以我們看到歐洲的交易量正在上升，但我們曾希望歐洲的交易量在第二季度已經開始回升，然後在第三和第四季度加速。

Now we're seeing all these things happening in the third quarter, and we are expecting in our guidance that this will continue in the fourth quarter. We have good reasons to believe that because we're not seeing any new lockdowns in Europe, we're not seeing any new lockdowns in the U.S.

現在我們看到所有這些事情都在第三季度發生，我們在我們的指導中預計這將在第四季度繼續下去。我們有充分的理由相信，因為我們在歐洲沒有看到任何新的封鎖，我們在美國也沒有看到任何新的封鎖。

So we think we are aligned there in our projections for the year with the continuation of a normalization of the market. Then you can ask me, are the script levels actually back to where they ought to be? And here, I would say, we're getting very close to the 2019 levels. However, of course, we would be expecting a growth in, let's say, European total script volume because that's what we normally see a low single-digit growth.

因此，我們認為我們對今年的預測與市場正常化的繼續保持一致。那你可以問我，腳本關卡真的回到了應該在的地方嗎？在這裡，我想說，我們非常接近 2019 年的水平。但是，當然，我們會期待歐洲總劇本量的增長，因為這是我們通常看到的低個位數增長。

We haven't caught up with that lag of low single-digit growth in 2020, 2021, but we are sort of back to where we were in '19. If you look at psychiatrist, doctor visits in the U.S., then we were below in Q1. We were below in Q2. In Q3, we're just getting close to where it used to be, so to speak, in '19 before COVID. And I'm optimistic that once we get now into the fourth quarter, we will see for the first time since COVID started that doctor visits in psychiatrist offices will be above that slowdown that we've seen.

我們還沒有趕上 2020 年和 2021 年低個位數增長的滯後，但我們有點回到了 19 年的水平。如果你看一下美國的精神科醫生和醫生就診，那麼我們在第一季度就低於預期。我們在第二季度低於。在第三季度，我們剛剛接近它曾經的位置，可以這麼說，在 COVID 之前的 19 年。而且我很樂觀，一旦我們進入第四季度，我們將首次看到自 COVID 開始以來，精神科醫生辦公室的醫生訪問量將超過我們所看到的放緩。

So a lot of details, but really, it has affected us this year. It is normalizing. I would think that we would -- next year, in Q1, continue to see the normalization. This is, of course, based on the assumption that we continue to see a strong explanation drive, and then we'll continue to see a relative low level of severe cases in hospitals, which is the current trend line.

所以很多細節，但實際上，它影響了我們今年。它正在正常化。我認為我們將 - 明年第一季度繼續看到正常化。當然，這是基於我們繼續看到強大的解釋驅動力的假設，然後我們將繼續看到醫院中重症病例的相對較低水平，這是目前的趨勢線。

Any comments, Sven, on top of that?

對此，Sven 有什麼意見嗎？

No, I think you actually exhausted. I would say, the only risk factor I see is the cough and cold portfolio that's for U.S. generics but also for our European OTC business because in 2020, or 2020, 2021, we didn't have a real cough and cold season due to the social distancing, and that basically should happen or normalize also next year.

不，我認為你實際上已經筋疲力盡了。我想說，我看到的唯一風險因素是咳嗽和感冒產品組合，它既適用於美國仿製藥，也適用於我們的歐洲非處方藥業務，因為在 2020 年或 2020 年、2021 年，我們沒有真正的咳嗽和感冒季節，因為社交距離，這基本上應該在明年發生或正常化。

Thanks, Sven. Then on AJOVY, Japan and AUSTEDO, China. We're very happy about the launch in Japan of AJOVY, and we'll be going for prevention of migraine. We think it has great potential. There's a big market for this in Japan. In Japan and in China, the way products penetrate is, I would say, slow and steady because there's -- first, you get the approval. You get the price, which is set by the government. So you don't have a lot of hassle with the pricing. You don't have pricing negotiations like that. You had that already. So that's the easy part, but you need to get on what's called hospital listings, both in Japan and China.

謝謝，斯文。然後是日本的 AJOVY 和中國的 AUSTEDO。我們對 AJOVY 在日本的推出感到非常高興，我們將致力於預防偏頭痛。我們認為它有很大的潛力。這在日本有很大的市場。在日本和中國，產品滲透的方式，我想說，緩慢而穩定，因為首先，你得到了批准。你得到價格，這是由政府設定的。因此，您在定價方面沒有太多麻煩。你沒有這樣的定價談判。你已經有了。所以這很容易，但你需要在日本和中國獲得所謂的醫院列表。

So actually, it's the same pattern for AJOVY and AUSTEDO. As you work through all the hospital listings, you get the product on there, and then your scripts start to take off and gradually build up. So when it comes to the fourth quarter of this year, AJOVY sales in Japan, AUSTEDO sales in China will still be marginal. They will not have a major impact, but in both markets, we are happy about the development. And the numbers will be accelerating over the next 10 years. So it's a steady buildup. It's a good launch in both cases, and we are very happy about the products reaching more major markets.

所以實際上，AJOVY 和 AUSTEDO 的模式是一樣的。當您瀏覽所有醫院列表時，您會在那裡獲得產品，然後您的腳本開始起飛並逐漸建立。所以說到今年第四季度，AJOVY在日本的銷量，AUSTEDO在中國的銷量依然會微不足道。它們不會產生重大影響，但在這兩個市場，我們都對發展感到高興。在接下來的 10 年裡，這個數字將會加速增長。所以這是一個穩定的積累。在這兩種情況下，這都是一次很好的發布，我們對產品進入更多主要市場感到非常高興。

So Gary, thanks for the questions. I think with that, we will end the call. Over to the operator.

所以加里，謝謝你的問題。我認為，我們將結束通話。交給運營商。

There are no further questions. I would like to hand the call over to our speakers for closing remarks.

沒有進一步的問題。我想把電話交給我們的發言者來做閉幕詞。

Thank you everybody for joining us for the call today. As always, we're happy to take any questions you have today, tomorrow, and in the coming weeks. Take care and be well.

感謝大家今天加入我們的電話會議。一如既往，我們很樂意回答您今天、明天和未來幾週內的任何問題。照顧好自己。

This does conclude our conference for today. This conference will be available for replay after 2:00 p.m. Eastern Time today through until November 26, 2021. You may access the remote or play system at any time by dialing 0044-333-300-9785 and entering the access code 6466787. The number again is 0044-333-300-9785 with access code 6466787.

這確實結束了我們今天的會議。本次會議將於下午 2:00 後重播。東部時間今天到 2021 年 11 月 26 日。您可以隨時通過撥打 0044-333-300-9785 並輸入訪問代碼 6466787 訪問遠程或播放系統。該號碼再次為 0044-333-300-9785 訪問代碼 6466787。

Thank you for participating. You may all disconnect.

感謝您的參與。你們都可以斷開連接。