Teva Pharmaceutical Industries Ltd (TEVA) 2022 Q1 法說會逐字稿

Good day, and thank you for standing by, and welcome to Teva's First Quarter 2022 Financial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

美好的一天，感謝您的支持，歡迎參加 Teva 2022 年第一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, [Ron] Mannix, Senior Vice President, Investor Relations. Please go ahead, sir.

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 [Ron] Mannix。請繼續，先生。

Thank you, Annette. Thank you, everyone, for joining us today to discuss Teva's first 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，安妮特。謝謝大家今天加入我們討論梯瓦（Teva）2022 年第一季度的財務業績。我們希望您有機會查看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副本。

Please review our forward-looking statements on Slide #2. Additional information regarding these statements and our non-GAAP financial measures is available on our earnings release and in our SEC Forms, 10-K and 10-Q.

請查看我們在幻燈片 #2 上的前瞻性陳述。有關這些報表和我們的非 GAAP 財務指標的更多信息，請參閱我們的收益發布和我們的 SEC 表格 10-K 和 10-Q。

To begin today's call, 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.

為了開始今天的電話會議，梯瓦 (Teva) 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 將跟進更詳細的財務業績，包括我們的 2022 年財務展望。

Joining Kare and Eli on the call today is Sven Dethlefs Teva's Head of North America Commercial, who will be available during the question-and-answer session that will follow the presentation. Please note that today's call will run approximately 1 hour.

今天與 Kare 和 Eli 一起參加電話會議的是 Sven Dethlefs Teva 的北美商業負責人，他將在演講後的問答環節中與他交談。請注意，今天的通話將持續大約 1 小時。

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

有了這個，我現在將把電話轉給 Kare。凱爾，如果你願意，好嗎？

Thank you. Welcome, everyone. I'm happy to present a solid first quarter of this year, with continued progress on many fronts. If we take a look at the financials, then revenues came in at $3.7 billion, our adjusted EBITDA came in at $1.1 billion and our GAAP diluted loss per share was $0.86 and our non-GAAP diluted EPS came in at $0.55. Free cash flow came in at $117 million, and we're happy to show you that the debt reduction continued and net debt is now reduced to $20.7 billion.

謝謝你。歡迎大家。我很高興向大家展示今年第一季度的穩健表現，在許多方面都取得了持續進展。如果我們看一下財務狀況，那麼收入為 37 億美元，我們調整後的 EBITDA 為 11 億美元，我們的 GAAP 攤薄每股虧損為 0.86 美元，我們的非 GAAP 攤薄每股收益為 0.55 美元。自由現金流為 1.17 億美元，我們很高興地向您展示，債務減少仍在繼續，淨債務現已減少至 207 億美元。

Our 2022 revenue outlook has been revised slightly downward mainly due to foreign exchange headwinds. All the other key components, as we will show you later, are being reaffirmed.

我們的 2022 年收入展望略有下調，主要是由於外匯逆風。正如我們稍後將向您展示的那樣，所有其他關鍵組件都得到了重申。

On the business side, we were very happy to see continued growth of AUSTEDO prescriptions, growing to a new all-time high. And at the same time, we also saw a growth in market share for our other key growth driver AJOVY, where we saw a strong development in Europe and also a nice progress in the U.S.

在業務方面，我們很高興看到 AUSTEDO 處方的持續增長，增長到歷史新高。同時，我們還看到我們的其他主要增長動力 AJOVY 的市場份額有所增長，我們看到了歐洲的強勁發展以及美國的良好進展。

In Europe, our generics and OTC markets were recovering following the easing of COVID-19 restrictions. So we saw a comeback of volumes and a nice continued strong market position in all key markets. North American generics, we are very happy to launch the new generic Revlimid, which did very well, and that was partly compensating for the lack of TRUVADA and Atripla sales that we had last year and also a decline in ProAir sales. Our biosimilar pipeline is progressing very nicely. We're excited about biosimilar Humira, which we now have a settled entry date of July 2023 for next year. And of course, we have there pending FDA approval.

在歐洲，隨著 COVID-19 限制的放鬆，我們的仿製藥和非處方藥市場正在復蘇。因此，我們看到了銷量的回升，以及所有主要市場的持續強勁市場地位。北美仿製藥，我們很高興推出新的仿製藥 Revlimid，它的表現非常好，這在一定程度上彌補了我們去年 TRUVADA 和 Atripla 銷量的不足以及 ProAir 銷量的下降。我們的生物仿製藥管道進展順利。我們對生物仿製藥 Humira 感到興奮，我們現在已確定明年 2023 年 7 月的進入日期。當然，我們還有待 FDA 批准。

If we move to the next slide, then you can see a highlight on the opioid litigation .As you all know and we also settled in Florida in March. And we have, based on this, also changed our accrual on the balance sheet and Eli Kalif will comment a bit on that later.

如果我們轉到下一張幻燈片，那麼您會看到阿片類藥物訴訟的一個亮點。眾所周知，我們也於 3 月在佛羅里達州定居。基於此，我們也改變了我們在資產負債表上的應計項目，Eli Kalif 稍後將對此發表評論。

There are 2 ongoing trials right now, one in West Virginia and one in San Francisco, both are bench trials, which means there is a judge presiding it, there's no jury. Our experience with bench trials recently has been positive. We had the trial in California, in Orange County, where we won a clear victory, and there was also J&J that appealed to the Oklahoma Supreme Court, which was also a bench trial, where there was also a win. We are in ongoing negotiations, and we are hopefully that we can settle this with a nationwide settlement for all states sometime before the end of this year.

目前有 2 項審判正在進行中，一項在西弗吉尼亞州，一項在舊金山，都是替補審判，這意味著有法官主持，沒有陪審團。我們最近在台架試驗方面的經驗是積極的。我們在加利福尼亞州奧蘭治縣進行了審判，我們贏得了明顯的勝利，還有強生公司向俄克拉荷馬州最高法院提出上訴，這也是一個替補審判，在那裡也取得了勝利。我們正在進行談判，我們希望我們能在今年年底前的某個時候通過全國范圍內的解決方案來解決這個問題。

If we go to the next slide, and here you can see our revenue development. And you can see that in the first quarter, we had 2, you could say, negative developments compared to the first quarter of '21. One was that the exchange rate between Europe and U.S. between the euro and the dollar worsened, so there was a significant increase in the dollar value in euros. And that basically meant that the reported euro sales in dollars is down. In underlying currencies, the sales are actually up. And we see, as I said before, a positive development of volumes in the generic space in Europe.

如果我們轉到下一張幻燈片，您可以在這裡看到我們的收入發展。你可以看到，在第一季度，與 21 年第一季度相比，我們有 2 個負面發展。一是歐洲和美國之間的歐元對美元匯率惡化，因此以歐元計算的美元價值大幅上漲。這基本上意味著以美元計價的歐元銷售額下降了。在基礎貨幣中，銷售額實際上是上升的。正如我之前所說，我們看到歐洲仿製藥領域的銷量出現了積極的發展。

In the U.S., the key difference here is really, like I mentioned before, that we had TRUVADA and Atripla sales in the first quarter of '21, and we have had Revlimid sales in first quarter '22, but not to the same extent. And in international markets, you see a very stable development.

在美國，就像我之前提到的那樣，這裡的關鍵區別實際上是，我們在 21 年第一季度有 TRUVADA 和 Atripla 的銷售，我們在 22 年第一季度有 Revlimid 的銷售，但程度不同。在國際市場上，您會看到非常穩定的發展。

If we go to the next slide, then here, as I comment on AUSTEDO, you can see that we have an all-time high TRx count in the end of the first quarter. If you look at the revenues, then we had the usual swing there where the first quarter is always low and there are really 2 main reasons for it. One is the spec buying that we see in the fourth quarter due to the fact that we traditionally now take our price increases in the very first week of the year. And the other one is the fact that the donut hole effects reset of patient deductible programs and therefore, we see less demand in the first quarter. We expect the demand, of course, to swing back up as it has done all years based on the prescriptions, and we are still maintaining the outlook for AUSTEDO for the year of $8 billion in sales.

如果我們轉到下一張幻燈片，那麼在這裡，正如我對 AUSTEDO 的評論，您可以看到我們在第一季度末的 TRx 計數創下歷史新高。如果你看一下收入，那麼我們在第一季度一直處於低位，這確實有兩個主要原因。一個是我們在第四季度看到的規格購買，因為我們傳統上現在在今年的第一周進行價格上漲。另一個原因是甜甜圈洞會影響患者免賠額計劃的重置，因此，我們看到第一季度的需求減少。當然，我們預計需求會回升，就像多年來根據處方所做的那樣，我們仍然維持 AUSTEDO 年度銷售額 80 億美元的前景。

If we go to the next slide, and here, you can see AJOVY. And in the U.S., you can see that we also there have an all-time high of the TRx. And you can also see that in Europe, we have an all-time high of the monthly volume market share, which is now up to 30%. I've said before that we are expecting to see 1/3 of the market in all key markets, including Europe and U.S. So we are really aiming for at least a 33% market share in both North America and Europe, and we are slowly getting there, which is very, very nice. You can also see here on the sales numbers that the sales in Europe are now getting up and being close to the U.S. sales, and we expect that to continue going forward. So we see very positive both profitability and momentum in Europe.

如果我們轉到下一張幻燈片，在這裡，您可以看到 AJOVY。在美國，你可以看到我們的 TRx 也創下歷史新高。您還可以看到，在歐洲，我們的月銷量市場份額創下歷史新高，現在高達 30%。我之前說過，我們希望在包括歐洲和美國在內的所有主要市場中佔據 1/3 的市場份額。所以我們的目標是在北美和歐洲至少佔據 33% 的市場份額，而且我們正在慢慢到達那裡，非常非常好。您還可以在此處看到歐洲的銷售額現在正在上升並接近美國的銷售額，我們預計這種情況會繼續發展。因此，我們認為歐洲的盈利能力和發展勢頭都非常樂觀。

If you go to the next slide, then we have the news here that we communicated some weeks ago that we received a CRL on risperidone LAI. So we will be answering the questions that we got from FDA. We expect that this could cause a delay of a refiling with some up to 6 months and then probably a 6-month review period. We still have strong belief in the concept and in the efficacy. So we still believe to get this product approved, but there will likely be a delay of up to 12 months on it.

如果您轉到下一張幻燈片，那麼我們這裡有一個消息，我們在幾週前傳達了我們收到了關於利培酮 LAI 的 CRL。所以我們將回答我們從 FDA 那裡得到的問題。我們預計這可能會導致重新申請延遲最多 6 個月，然後可能需要 6 個月的審核期。我們仍然對概念和功效有堅定的信念。所以我們仍然相信這款產品會獲得批准，但它可能會延遲長達 12 個月。

Another thing you can see here is illustrated on the next slide, and that's the fact that we have a very broad biosimilar portfolio. We have 13 biosimilars in development now, 7 in-house programs and 6 that we have from partners. And of course, we are very excited about the big launch that's upcoming next year, the Humira launch. We now have a settled entry date of July 2023. And as you know, this is a very good product. It's the high concentration version, Citrate free and interchangeable. So we are looking forward to that. We think we are still seeing very good performance on the ones we have launched. So TRUXIMA is doing exceedingly well in the marketplace still holding on to something like 1/4 of the Rituxan market. And we also have now that this year, we will see a launch in Europe of a LUCENTIS biosimilar. So all in all, it's going very well on the biosimilar side. And longer term, of course, we are aiming for addressing some roughly 80% of the value in biologic products going off patent, both in North America and in Europe.

您可以在這裡看到的另一件事在下一張幻燈片中進行了說明，這就是我們擁有非常廣泛的生物仿製藥產品組合的事實。我們現在有 13 個生物仿製藥正在開發中，7 個內部項目和 6 個來自合作夥伴。當然，我們對即將在明年推出的 Humira 的大型發布感到非常興奮。我們現在確定的進入日期是 2023 年 7 月。如您所知，這是一款非常好的產品。它是高濃度版本，不含檸檬酸鹽，可互換。所以我們對此充滿期待。我們認為我們仍然看到我們推出的產品表現非常出色。所以 TRUXIMA 在市場上的表現非常好，仍然佔據了 Rituxan 市場的 1/4。而且我們現在還知道，今年我們將看到在歐洲推出 LUCENTIS 生物仿製藥。總而言之，它在生物仿製藥方面進展順利。當然，從長遠來看，我們的目標是在北美和歐洲解決大約 80% 的生物產品專利到期問題。

On the next slide, you see another important element of our restructuring, which is basically, you could say, post the patent (inaudible) of COPAXONE to get our operating margin back up where it should be. And as you know, back in 2018, we set a target of 20%. And you can see here now that we're getting very close. And just for the record, I would like to say, even though the graph could look like it's flattening out, then, of course, we're not going to stop at 28%. We will set new long-term targets, which will be an improvement and we will communicate those targets within the coming year.

在下一張幻燈片中，您會看到我們重組的另一個重要因素，基本上，您可以說，發布 COPAXONE 的專利（聽不清），以使我們的營業利潤率恢復到應有的水平。如您所知，早在 2018 年，我們就設定了 20% 的目標。現在你可以在這裡看到我們已經非常接近了。只是為了記錄，我想說，即使圖表看起來正在變平，當然，我們不會停留在 28%。我們將設定新的長期目標，這將是一個進步，我們將在來年傳達這些目標。

The same goes for the next slide where we have another of our key financial targets shown, that's the net debt reduction. As you know, we have a target to reduce net debt. And also there, we'll keep on driving it down. And the same goes for the net debt-to-EBITDA ratio. We will be setting a new target for that. We have a target for end of '23, below 3, and we'll be setting a new long-term financial targets also for the net debt to EBITDA within the coming year.

下一張幻燈片也是如此，我們展示了另一個關鍵財務目標，即淨債務減少。如您所知，我們的目標是減少淨債務。而且在那裡，我們將繼續推動它。淨債務與 EBITDA 的比率也是如此。我們將為此設定一個新目標。我們的目標是 23 年底，低於 3，我們還將為來年的 EBITDA 淨債務設定新的長期財務目標。

On the next page, you can see we're making a little commercial for our upcoming ESG progress report, which will come out in about a week's time. And we've been working very hard on this for a number of years, and we are setting some very ambitious targets. We're also making sure that our ESG performance is linked to executive compensation. We also have secured now that our -- you could say, our financing, our debt is linked to sustainability. Eli Kalif will tell you later on about our new RCF, which also has a sustainability element. And although, we are very happy about our performance, and we're also happy that it's been seen outside the company. So we see improved performance on our ESG ratings, which, of course, is a good sign that we are doing the right thing.

在下一頁，您可以看到我們正在為即將發布的 ESG 進度報告製作一個小廣告，該報告將在大約一周後發布。多年來，我們一直在為此努力工作，我們正在設定一些非常雄心勃勃的目標。我們還確保我們的 ESG 績效與高管薪酬掛鉤。我們現在還確保我們的 - 你可以說，我們的融資，我們的債務與可持續性有關。 Eli Kalif 稍後將向您介紹我們的新 RCF，它也具有可持續性元素。儘管如此，我們對我們的表現感到非常高興，我們也很高興在公司之外看到它。因此，我們看到 ESG 評級的表現有所改善，這當然是我們做正確事情的好跡象。

If we go to the next slide, then that's a slide that those of you who follow the company, you've seen it many times. We've shown it since 2018. It's our long-term financial targets. There's no change here. And the only change is sort of a little commercial here also that within the coming year we will come up with new long-term financial targets taking us into the next 5-year period. I look forward to that, of course, and I also look forward to meeting these targets at the end of 2023.

如果我們轉到下一張幻燈片，那是那些關注該公司的人已經看過很多次的幻燈片。自 2018 年以來，我們已經展示了這一點。這是我們的長期財務目標。這裡沒有變化。唯一的變化是有點商業化，在未來一年內，我們將提出新的長期財務目標，將我們帶入下一個 5 年。我當然很期待，我也期待在 2023 年底實現這些目標。

So with that, I will hand you over to Eli Kalif.

因此，我將把你交給 Eli Kalif。

Thank you, Kare, and good morning and good afternoon to everyone. I'll begin my review of the first quarter of 2022 financial results on Slide 16, starting with our GAAP performance. Revenues in the first quarter of 2022 were $3.7 billion, a decrease of 8% or 5% in local currency terms compared to the first quarter of 2021. This decrease was mainly due to lower revenues in our North America segment, mainly driven by generics products and COPAXONE, partially offset by higher revenue from ANDA and generic products in our Europe segment. We have been seeing generic product launches for Teva towards the end of the first quarter. However, the decrease in our revenues from generic products in North America is still affected by the low number of launches in 2021.

謝謝你，Kare，大家早上好，下午好。我將在幻燈片 16 上開始審查 2022 年第一季度的財務業績，從我們的 GAAP 表現開始。 2022 年第一季度的收入為 37 億美元，以當地貨幣計算，與 2021 年第一季度相比下降 8% 或 5%。這一下降主要是由於我們北美部門的收入下降，主要受仿製藥產品的推動和 COPAXONE，部分被我們歐洲部門 ANDA 和仿製藥的收入增加所抵消。我們一直在看到梯瓦（Teva）在第一季度末推出通用產品。然而，我們在北美的仿製藥收入減少仍然受到 2021 年推出數量少的影響。

In Q1 2022, we recorded a GAAP operating loss of $713 million compared to operating income of $434 million in Q1 2021. GAAP net loss of $955 million compared to a net income of $77 million in Q1 2021. A GAAP loss per share of $0.86 compared to earnings per share of $0.07 in the same period a year ago. GAAP operating loss, net loss and loss per share were mainly driven by higher legal settlement expenses related to an update of the estimated settlement provision recorded in connection with the remaining opioid cases in the first quarter of 2022.

在 2022 年第一季度，我們的 GAAP 營業虧損為 7.13 億美元，而 2021 年第一季度的營業收入為 4.34 億美元。GAAP 淨虧損為 9.55 億美元，而 2021 年第一季度淨收入為 7700 萬美元。GAAP 每股虧損為 0.86 美元去年同期每股收益為 0.07 美元。 GAAP 經營虧損、淨虧損和每股虧損主要是由於與 2022 年第一季度剩餘阿片類藥物案件相關的估計結算準備金更新相關的法律結算費用增加。

Foreign exchange rate movements during the first quarter of 2022, including hedging effects negatively impacted revenue and GAAP operating income by $133 million and $56 million, respectively, compared to the first quarter of 2021. This was a result of impact of the stronger U.S. dollar, especially versus the euro. As a reminder, approximately 50% of our revenues come from sales denominated in non-U.S. dollar currency.

與 2021 年第一季度相比，2022 年第一季度的匯率變動（包括對沖效應）對收入和 GAAP 營業收入的負面影響分別為 1.33 億美元和 5600 萬美元。這是美元走強影響的結果，尤其是對歐元。提醒一下，我們大約 50% 的收入來自以非美元貨幣計價的銷售。

Turning to Slide 17. You can see that the net non-GAAP adjustment in the first quarter of 2022 were $1.564 billion versus $621 million in Q1 2021. Non-GAAP operating income, net income and earnings per share for the first quarter of 2022 were adjusted to exclude these items. Notable non-GAAP adjustments include legal settlement of $1.124 billion mainly due to an update of the estimated opioid settlement provision mentioned above. Amortization of purchased intangible assets totaling $200 million, the majority of which is included in cost of goods sold and impairment of long-lived assets totaling $165 million.

轉到幻燈片 17。您可以看到，2022 年第一季度的非 GAAP 淨調整為 15.64 億美元，而 2021 年第一季度為 6.21 億美元。2022 年第一季度的非 GAAP 營業收入、淨收入和每股收益分別為調整以排除這些項目。值得注意的非公認會計原則調整包括 11.24 億美元的法律和解，這主要是由於更新了上述估計的阿片類藥物和解條款。購買的無形資產攤銷總額為 2 億美元，其中大部分計入銷售成本和長期資產減值總額 1.65 億美元。

Moving to Slide 18 for a review of our non-GAAP performance. I've already discussed our first quarter revenues, which totaled approximately $3.7 billion. Now let's move down to the P&L and look on the margin. Despite the 7% quarter-over-quarter decline in non-GAAP gross profit, our total non-GAAP gross profit margin improved to 54.2% compared to 53.8% in Q1 2021. The increase in non-GAAP gross profit margin was mainly driven by our continuous efforts to improve our cost of goods sold, network consolidation activities as well as a change in product portfolio mix in our international market segments partially offset by unfavorable mix of generic products in our North America segment and the lower revenues from COPAXONE.

移至幻燈片 18 以查看我們的非公認會計原則表現。我已經討論了我們第一季度的收入，總收入約為 37 億美元。現在讓我們向下移動到損益表並查看保證金。儘管非 GAAP 毛利潤環比下降 7%，但我們的非 GAAP 總毛利率從 2021 年第一季度的 53.8% 提高至 54.2%。非 GAAP 毛利率的增長主要是由於我們不斷努力改善我們的銷售成本、網絡整合活動以及我們國際細分市場的產品組合組合的變化，部分被我們北美細分市場的通用產品組合不利和 COPAXONE 收入的下降所抵消。

Our non-GAAP operating margin was 27.7% versus 27.1% in Q1 '21. This increase was driven mainly by higher gross profit margin mentioned above, and lower operating expenses, which I will discuss in the next slide. We ended the quarter with a non-GAAP earnings per share of $0.55 compared to $0.63 in Q1 2021, mostly due to lower revenue which were negatively impacted by $133 million from exchange rate fluctuation.

我們的非 GAAP 營業利潤率為 27.7%，而 21 年第一季度為 27.1%。這一增長主要是由於上述較高的毛利率和較低的運營費用，我將在下一張幻燈片中討論。我們在本季度末的非公認會計準則每股收益為 0.55 美元，而 2021 年第一季度為 0.63 美元，這主要是由於受到匯率波動 1.33 億美元的負面影響的收入下降。

Turning to Slide 19. We see that our quarterly spend base declined by $257 million, or $183 million net of FX. Most of the decrease was due to a lower cost of goods sold, partially related to lower sales as well to our ongoing efforts to transform our global operational network. Lower operating expenses also contributed to the decline in our spend base, mainly due to the ongoing active management of such expenses. We expected the overall annual spend base to remain below $12 billion as we continue to focus our efforts on reducing and optimizing our cost of goods sold. These ongoing efforts are expected to help us partially mitigate the global macroeconomic headwinds, including inflation and higher cost of labor and eventually lead to stabilize our operating margin above the level of 27% in 2022, with the ultimate goal of 28% operating margin by end of 2023.

轉到幻燈片 19。我們看到我們的季度支出基數下降了 2.57 億美元，即扣除外匯後的 1.83 億美元。大部分下降是由於銷售商品成本下降，部分原因是銷售額下降，以及我們不斷努力改造我們的全球運營網絡。較低的運營費用也導致我們的支出基礎下降，主要是由於對此類費用的持續積極管理。我們預計整體年度支出基數將保持在 120 億美元以下，因為我們將繼續致力於降低和優化我們的銷售成本。這些正在進行的努力預計將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，並最終使我們的營業利潤率在 2022 年穩定在 27% 的水平以上，最終目標是到年底營業利潤率達到 28% 2023 年。

Turning to free cash flow on Slide 20. Our free cash flow in the first quarter of 2022 was $117 million. Teva free cash flow tends to face headwinds at the start of the year due to unusual timing of annual bonus payments out of the first quarter. In addition, we faced challenges due to timing of certain items related to our working capital as a result of operational ramp-up in relation to our annual production plan. Today, we are reaffirming our 2022 free cash flow guidance which we 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 our free cash flow to pick up during the next 3 quarters as we continue to drive working capital improvements. 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 long-term financial targets.

轉向幻燈片 20 上的自由現金流。我們在 2022 年第一季度的自由現金流為 1.17 億美元。由於第一季度的年度獎金支付時間異常，Teva 的自由現金流往往在年初面臨逆風。此外，由於與我們的年度生產計劃相關的運營加速，我們面臨與營運資金相關的某些項目的時間安排的挑戰。今天，我們重申我們在 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將在 19 億美元至 22 億美元之間。隨著我們繼續推動營運資金的改善，我們預計我們的自由現金流將在未來三個季度回升。作為我們長期財務目標的一部分，我們仍有望在 2023 年底之前實現 80% 或更高的自由現金流轉換目標。

Turning to Slide 21. Our net debt at the end of Q1 2022 was $20.7 billion compared to $20.9 billion at the end of 2021. The decrease in our gross net debt was mainly due to exchange rate fluctuation. Our net debt to EBITDA slightly increased coming in 4.29 ratio times of Q1 2022. However, we expect it to be further decline as we continue to make progress towards our 2023 target of being below 3x by the end of that year. Debt reduction continues to be our primary focus and main use of cash. Upcoming maturities include $1.4 billion in 2022, which will be covered by our liquidity and expected cash flow generation. I would like to inform you that we recently entered into an unsecured syndicated sustainability-linked revolving credit facility of $1.8 billion, replacing our existing facility. It is linked to sustainable performance targets and reinforce our continued intention to establish a direct link between our corporate responsibility commitments and our funding strategy.

轉到幻燈片 21。我們在 2022 年第一季度末的淨債務為 207 億美元，而 2021 年底為 209 億美元。我們的淨債務總額減少主要是由於匯率波動。我們的淨債務與 EBITDA 的比率在 2022 年第一季度的 4.29 倍內略有增加。但是，隨著我們繼續朝著 2023 年年底低於 3 倍的目標取得進展，我們預計淨債務將進一步下降。減債仍然是我們的主要關注點和現金的主要用途。即將到期的包括 2022 年的 14 億美元，這將由我們的流動性和預期的現金流量產生。我想通知您，我們最近簽訂了一項價值 18 億美元的無擔保銀團可持續發展相關循環信貸融通，以取代我們現有的融通。它與可持續績效目標相關聯，並強化了我們在企業責任承諾和融資戰略之間建立直接聯繫的持續意圖。

So now turning to our non-GAAP financial outlook for 2022 on Slide 22. While we have experienced some recovery in many countries and products from effect of the global pandemic, we are unfortunately also seeing a strong foreign exchange headwinds affect our results. At current rates, we expect foreign exchange to have unfavorable impact on revenue. Therefore, we believe, at this time, it is prudent to adjust our guidance range for full year revenue from the original range of $15.6 billion to $16.2 billion to the new range of $15.4 billion to $16 billion. This lowers the midpoint of our range by $200 million. The new range includes an adjustment to our full year expectation for global sales of COPAXONE for which we are lowering our guidance by $100 million to $750 million due to increase in generic competition in the United States and the availability of alternative therapies as well as continued effect of foreign exchange fluctuation.

因此，現在在幻燈片 22 上轉向我們對 2022 年的非公認會計準則財務展望。雖然我們在許多國家和產品中經歷了全球大流行影響的一些復甦，但不幸的是，我們也看到強大的外匯逆風影響了我們的業績。按照目前的匯率，我們預計外匯將對收入產生不利影響。因此，我們認為，此時將全年收入的指導範圍從原來的 156 億美元至 162 億美元調整為新的 154 億美元至 160 億美元的範圍是審慎的。這將我們範圍的中點降低了 2 億美元。新範圍包括對我們對 COPAXONE 全球銷售額的全年預期的調整，由於美國仿製藥競爭的加劇和替代療法的可用性以及持續效果，我們將我們的指導下調 1 億美元至 7.5 億美元外匯波動。

For our 2022 financials, operating income, EBITDA, earnings per share and free cash flow, we are reaffirming the range provided in February. We expect a gradual pickup in the second quarter following the first quarter, which is expected to be the lowest of our 4 quarters for sales and margins. We still expect that approximately 45% of our 2022 sales will be generated in the first half of the year and approximately 55% in the second half. As discussed earlier, we also still expect continued impact of foreign exchange fluctuations on our results.

對於我們 2022 年的財務、營業收入、EBITDA、每股收益和自由現金流，我們重申了 2 月份提供的範圍。我們預計在第一季度之後的第二季度將逐漸回升，這預計將是我們四個季度中銷售額和利潤率最低的一個季度。我們仍然預計，我們 2022 年銷售額的約 45% 將在上半年產生，約 55% 將在下半年產生。如前所述，我們仍預計外匯波動會對我們的業績產生持續影響。

This concludes my review of Teva results for the first quarter of 2022. We'll now open the call for questions and answers. Operator, would you please open the call for questions?

我對梯瓦 (Teva) 2022 年第一季度業績的回顧到此結束。我們現在開始徵集問答。接線員，請您打開電話提問嗎？

(Operator Instructions)

（操作員說明）

And the first question comes from the line of Balaji Prasad from Barclays.

第一個問題來自 Barclays 的 Balaji Prasad。

This is Balaji from Barclays. Firstly, on global opioid settlement, Kare, I couldn't help notice that you seem to call out a more specific timeline this time around for the first time, stating that you expect to see a settlement by the end of the year. So could you give some incremental color around the progress that you're seeing at least to the extent that is disclosable? And what role will the state settlements play as you go towards this date?

這是來自巴克萊的巴拉吉。首先，關於全球阿片類藥物解決方案，Kare，我不禁注意到您這次似乎首次提出了更具體的時間表，並表示您希望在今年年底前看到解決方案。那麼，您能否至少在可披露的範圍內為您所看到的進展提供一些增量顏色？當你走向這個日期時，州定居點將扮演什麼角色？

And secondly, on biosimilar HUMIRA, can you give your thoughts on the relevance of the high concentration interchangeability and the impact on share dynamics that you expect with or without this interchangeability?

其次，關於 HUMIRA 生物仿製藥，您能否就高濃度互換性的相關性以及您期望有或沒有這種互換性對股票動態的影響發表您的看法？

Thank you, Balaji. I didn't -- there was a small thing on your opioid question where the sound just dropped out. So I got it that you wanted some more color on it, but there was some specific element you asked about, which I couldn't hear.

謝謝你，巴拉吉。我沒有——關於你的阿片類藥物問題有一個小問題，聲音剛剛消失。所以我知道你想要更多的顏色，但是你問了一些特定的元素，我聽不到。

Yes. You seem to have been mentioning a more specific timeline for the first time, stating that you expect some progress by the end of the year. So I was asking what progress and what color you could provide further on it?

是的。您似乎第一次提到了更具體的時間表，並表示您預計到今年年底會取得一些進展。所以我在問你可以進一步提供什麼進展和顏色？

Okay. Thank you very much. So I'll take the first question, and then Sven can comment on Humira in the U.S. and those elements. So on the opioids, you can see that we have been doing a number of settlements on a state-by-state basis so far and you can see that there are some common elements there in all the settlements, which, you could say, 2 main elements. One is, it's a combination of product that can benefit people suffering from substance abuse. So we have products in there. And you can also see that we are paying over a longer period of time. And of course, the reason why we need to pay over a longer period of time is due to our balance sheet and the debt we just talked about. So the only way it's possible for us to do it is if we spread out the payments. And the other thing is, of course, we can bring value to the table due to the fact that we are one of the biggest manufacturers of generics in the world, if not the biggest, and also in North America, we have generic Narcan, which can be used to help people if they overdose. So we're very happy about those settlements. And in conjunction with that, we, of course, also have ongoing negotiations on a nationwide settlement, and we also believe we're getting closer there. So I'm slightly more optimistic on the time schedule now, and that's why I hope that we will see a nationwide settlement before the end of this year.

好的。非常感謝。所以我會回答第一個問題，然後 Sven 可以評論美國的 Humira 和那些元素。所以關於阿片類藥物，你可以看到到目前為止，我們一直在逐個州進行一些定居點，你可以看到所有定居點都有一些共同的元素，你可以說，2主要元素。一是，它是一種可以使遭受藥物濫用的人受益的產品組合。所以我們在那裡有產品。您還可以看到我們支付的時間更長。當然，我們需要在較長時間內支付的原因是我們的資產負債表和我們剛才談到的債務。因此，我們可以做到這一點的唯一方法是分攤付款。另一件事是，當然，我們可以帶來價值，因為我們是世界上最大的仿製藥製造商之一，即使不是最大的，在北美，我們也有仿製藥 Narcan，如果人們服用過量，它可以用來幫助他們。所以我們對這些定居點感到非常高興。與此相結合，我們當然也在就全國范圍內的解決方案進行談判，我們也相信我們離目標越來越近了。所以我現在對時間表稍微樂觀一些，這就是為什麼我希望我們能在今年年底之前看到全國性的解決方案。

Sven, will you address the biosims Humira question?

Sven，你會解決 biosims Humira 的問題嗎？

Yes. Thank you, Balaji. So on the biosimilars for HUMIRA, we have now a clear situation due to the settlement between Alvotech and AbbVie concerning the launch of this product. So we will be in the second wave in July 2023 with our product formulation. The product features themselves, I would say every single feature in itself is, of course, not a decisive factor, but it is the whole package of our product that makes it attractive. So it's citrate free, it's interchangeable and its high concentration and it also has an attractive auto-injector. And what we know with the payer discussions is that payers very well, of course, analyze the features of each product offering coming to the market in July next year, and we believe that the total package that we offer is highly attractive to provide us market access. That is one aspect of the product features. The second one is, of course, to create pull-through in the market once you have the product in the market because this product launch will behave not like a classical generic launch in the U.S., but it has more features of a European branded generic launch. And there, we know that the product features and the attractiveness of the package is quite important. So we are quite happy with the Alvotech HUMIRA biosimilar that we will launch next year.

是的。謝謝你，巴拉吉。因此，關於 HUMIRA 的生物仿製藥，由於 Alvotech 和 AbbVie 就該產品的推出達成和解，我們現在已經有了明確的情況。因此，我們的產品配方將在 2023 年 7 月進入第二波浪潮。產品本身的特點，我想說的是，每一個特點本身當然不是決定性因素，但正是我們產品的整個包裝使它具有吸引力。所以它不含檸檬酸鹽，可互換且濃度高，而且它還具有吸引人的自動注射器。我們從付款人的討論中了解到，付款人很好，當然，分析了明年 7 月上市的每種產品的特點，我們相信我們提供的總包非常有吸引力，可以為我們提供市場使用權。這是產品功能的一個方面。第二個當然是，一旦你將產品推向市場，就在市場上創造拉動效應，因為這種產品的推出將不像在美國推出的經典仿製藥，但它具有更多歐洲品牌仿製藥的特徵發射。在那裡，我們知道產品功能和包裝的吸引力非常重要。因此，我們對將於明年推出的 Alvotech HUMIRA 生物仿製藥非常滿意。

And 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 I wanted to get some additional thoughts from you, Kare, regarding business development and M&A and specifically, the extent to which you're prioritizing the addition of brand assets. And to that end, can you talk about your financial wherewithal to do consequential M&A? How large of this transaction can you contemplate both now and also in the context of the global settlement being effectuated. So I wanted to get your thoughts there. And then as a corollary to that, is it fair to say that you're going to look for neuroscience-focused assets or are you looking at other therapeutic verticals?

所以我想從你那裡得到一些額外的想法，Kare，關於業務發展和併購，特別是你優先考慮增加品牌資產的程度。為此，您能談談您進行後續併購的財務資源嗎？您現在以及在全球結算正在實施的情況下，您可以考慮這筆交易的規模有多大。所以我想了解你的想法。然後作為推論，可以說您將尋找以神經科學為重點的資產還是在尋找其他治療垂直領域？

Thank you for those 2 questions. I'll answer both of them. So first of all, of course, it will be nice to do some interesting M&A, but you've got to look at our balance sheet, and we don't really have any cash or significant debt capacity on our balance sheet. So that's not really going to happen in terms of any major transactions for the next several years. What you will see us doing, which is what we have been doing is, you could say, early stage in-licensing of interesting assets that we can take through development on our own all together with a partner. And that we will continue to do, of course, but you will not see us doing any major M&A transactions. We simply do not have the balance sheet for that as we speak, and that's with or without an opioid settlement. You could say M&A based on, you could say, [capital] as well based on share capital is a theoretical option, not with our current ratios, that would be value destroying for the shareholders. But potentially, in the future, if the share price improves, then of course, that is a theoretical opportunity. But cash-based acquisitions, no, that you'll not see in the coming years.

謝謝你的這2個問題。我會回答他們兩個。所以首先，當然，做一些有趣的併購會很好，但你必須看看我們的資產負債表，我們的資產負債表上並沒有任何現金或重大債務能力。因此，就未來幾年的任何重大交易而言，這不會真正發生。您將看到我們正在做的事情，也就是我們一直在做的事情，您可以說，我們可以通過自己與合作夥伴一起開發的有趣資產進行早期許可。當然，我們將繼續這樣做，但您不會看到我們進行任何重大的併購交易。在我們說話的時候，我們根本沒有資產負債表，不管有沒有阿片類藥物解決方案。你可以說基於[資本]以及基於股本的併購是一種理論上的選擇，而不是我們目前的比率，這將對股東造成價值破壞。但未來，如果股價上漲，那當然是理論上的機會。但是基於現金的收購，不，在未來幾年你不會看到。

Then in what areas do we want to do in these early stage in-licensing? Well, we basically focus on neuroscience and immunology. Those are the 2 areas where we have the most knowledge, and that's where we have our current portfolio. We have 15 very exciting biopharmaceutical projects right now in the clinic. And those will be there that we'll be focusing on. And some of the recent deals we've done with early-stage assets have also been in those areas. So we'll continue down that path. Thank you for the questions.

那麼在這些早期的許可中，我們想在哪些領域做呢？好吧，我們基本上專注於神經科學和免疫學。這是我們最了解的兩個領域，也是我們目前的投資組合。我們目前在臨床上有 15 個非常令人興奮的生物製藥項目。我們將重點關注這些。我們最近與早期資產進行的一些交易也涉及這些領域。所以我們將繼續沿著這條路走下去。謝謝你的提問。

And the next line -- or the next question comes from the line of Umer Raffat from Evercore ISI.

下一行——或者下一個問題來自 Evercore ISI 的 Umer Raffat 一行。

This is Eric Musonza speaking for Umer Raffat. Can you hear me just wanted to make sure. I've been having audio issues?

這是 Eric Musonza 為 Umer Raffat 發言。你能聽到我只是想確定一下。我一直有音頻問題？

We can hear you.

我們可以聽到你的聲音。

Great. I just have one quick question on opioids first. lately, we've been seeing a lot more of the states from the -- that opted out of the nationwide settlement reaching agreements on a state-by-state basis. Are these states requiring more cash per capita compared to those that were in the agreements from your perspective? And just one follow-up.

偉大的。我只有一個關於阿片類藥物的快速問題。最近，我們看到越來越多的州選擇退出全國性和解協議，逐州達成協議。從您的角度來看，與協議中的州相比，這些州是否需要更多的人均現金？只有一次跟進。

So no, that's not the case. If you look at, you could say, Texas and Florida, then, of course, it's a -- all the deals are slightly different, but the key elements are that, of course, we see products in there, we see cash in there, we see a long payment period in there, and that's what we've been saying from the beginning. If you want to think philosophically about what has changed then compared to the nationwide settlement where the 4 other big companies, the 3 big distributors and J&J, they offered cash only. Back then, we offered basically product only and a little bit of cash. And now we've adjusted it. And of course, it goes hand-in-hand with the fact that we have the capability now of paying slightly more cash than we could some years ago. We've stabilized the business. And if you sort of look at what we're doing right now with the individual states that we're settling, this is very much in line with what we would hope to do on a nationwide basis.

所以不，事實並非如此。如果你看看，你可以說，德克薩斯州和佛羅里達州，那麼，當然，所有的交易都略有不同，但關鍵因素是，當然，我們在那裡看到了產品，我們看到了那裡的現金，我們在那裡看到很長的付款期，這就是我們從一開始就一直在說的。如果你想從哲學上思考發生了什麼變化，那麼與其他 4 家大公司、3 大分銷商和強生在全國范圍內的結算相比，他們只提供現金。那時，我們基本上只提供產品和一點現金。現在我們已經對其進行了調整。當然，這與我們現在有能力支付比幾年前略多一點的現金這一事實密切相關。我們已經穩定了業務。如果你看看我們現在對我們正在定居的各個州所做的事情，這與我們希望在全國范圍內做的事情非常一致。

Got it. And just a follow-up on the AJOVY AUSTEDO that we saw in the U.S. It seems that consensus is expecting a bit more than what was actually reported. Do you think consensus numbers need to rebase or do you think the U.S. market has drivers that aren't being accounted for?

知道了。只是我們在美國看到的 AJOVY AUSTEDO 的後續行動。似乎共識預期比實際報導的要多一些。您是否認為共識數據需要重新調整，或者您認為美國市場是否存在未被考慮的驅動因素？

No, I don't think so. I think actually, the consensus numbers for the U.S. are pretty close on a full year basis. to our consensus numbers. So -- and we are reconfirming those. It's correct that if you look at the quarters, as I showed you, then we had this big swing always between fourth quarter, first quarter due to the spec buying and the donut hole. And we're also seeing that this year, but we are reconfirming our state outlook of $1 billion. So -- and that is the way I remember it from different consensus as I've seen, that's pretty close to the consensus in the marketplace.

不，我不這麼認為。我認為實際上，美國全年的共識數字非常接近。到我們的共識數字。所以 - 我們正在重新確認這些。正確的是，如果您查看季度，正如我向您展示的那樣，由於規格購買和甜甜圈洞，我們總是在第四季度和第一季度之間出現這種大幅波動。今年我們也看到了這一點，但我們正在重新確認我們對 10 億美元的州展望。所以 - 這就是我從不同的共識中記住它的方式，正如我所看到的，這非常接近市場上的共識。

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

下一個問題來自摩根大通的 Chris Schott。

Just 2 for me. I guess, first on the next set of guidance targets, I know you're going to give that later this year, but it seems like the past 5 years, we're kind of stabilizing the business, really focused on margin improvement. I guess, high level, as you think about kind of post 2023, does the focus pivot more to top line growth or is it still going to be a very margin-centric story? I'm kind of asking for maybe a bit of a preview of how to think about kind of Teva longer term? And I know we'll get more details later this year, but any color there would be appreciated.

對我來說只有2個。我想，首先關於下一組指導目標，我知道你會在今年晚些時候給出，但似乎在過去的 5 年裡，我們正在穩定業務，真正專注於提高利潤率。我想，高水平，當您考慮 2023 年後的那種情況時，重點是更多地轉向頂線增長，還是仍將是一個非常以利潤為中心的故事？我有點想了解一下如何看待 Teva 的長期前景？我知道我們會在今年晚些時候獲得更多細節，但任何顏色都會受到讚賞。

And then the second one for me was on the quarterly revenue progression. You're talking about this kind of 45-55 split for the year, which I think is a bit more back-end loaded than we typically see. I guess how much of that ramp is tied to products where you have, I guess, full clarity on approval and a more commercial execution related versus how much of that is tied to assets where maybe you're still waiting for approval? I'm just trying to get a sense of just the risk tied to FDA or regulatory on getting to that second half ramp?

然後對我來說第二個是關於季度收入的增長。您說的是今年的這種 45-55 拆分，我認為後端負載比我們通常看到的要多一些。我猜這個坡道有多少與您擁有的產品相關，我猜，完全清晰的批准和更多的商業執行相關，而其中有多少與您可能仍在等待批准的資產相關？我只是想了解一下與 FDA 或監管部門在進入下半年坡道時相關的風險？

Yes. Thanks for those questions, Chris. So I'll give it a shot at both of them and then Sven can give some additional color to the last one. So if you think about what we will be communicating in terms of long-term guidance later sometime in the coming year, then you should really think about it as explaining the same plus more, I would say. So we will not get away from the fact that we need to keep on generating cash and we need to keep on reducing our debt. I think that's pretty obvious to anybody who is looking at the business. We also want to secure that the business is sustainable. So as I said before, we also want to give a target for continued margin improvement. But you're also right that, of course, we would also like to see the business returning into a growth mode with increasing revenues. So I think you should expect -- you could say, more of the same with an addition would be the way I would phrase it by now. And then I, of course, I look forward to communicating the specifics.

是的。謝謝你的這些問題，克里斯。所以我會試一試他們兩個，然後 Sven 可以為最後一個添加一些額外的顏色。因此，如果您考慮我們將在來年晚些時候就長期指導進行溝通，那麼您應該將其真正考慮為解釋相同的內容以及更多內容，我會說。因此，我們不會逃避這樣一個事實，即我們需要繼續產生現金，我們需要繼續減少我們的債務。我認為這對任何關注業務的人來說都是顯而易見的。我們還希望確保業務是可持續的。因此，正如我之前所說，我們還想給出一個持續提高利潤率的目標。但是您也說得對，當然，我們也希望看到業務恢復增長模式並增加收入。所以我認為你應該期待 - 你可以說，更多相同的添加將是我現在的措辭方式。然後，當然，我期待著交流具體細節。

On the revenue side, it's a combination. You could say we knew already when we communicated for the full year that we saw some elements in the U.S. where there were some swing factors between the fourth and the first quarter. So we communicated that. We also have a number of launches that we knew would happen, and that would have a positive effect, which are, you could say, date certain. And then we have, of course, an accumulated effect also of the progress -- ongoing progress of AUSTEDO, AJOVY and so on is doing very well, as you've seen in Europe, and we see very nice script numbers on AUSTEDO. And then, of course, we also have some launches in the U.S. where we don't have the actual approval yet.

在收入方面，這是一個組合。你可以說我們在全年溝通時已經知道，我們在美國看到了一些因素，在第四季度和第一季度之間存在一些波動因素。所以我們進行了溝通。我們也有一些我們知道會發生的發布，這會產生積極的影響，你可以說，日期是確定的。當然，我們還有進度的累積效應——AUSTEDO、AJOVY 等的持續進展做得非常好，正如你在歐洲看到的那樣，我們在 AUSTEDO 上看到了非常好的腳本編號。然後，當然，我們在美國也有一些發射，我們還沒有獲得實際批准。

So maybe Sven, you can comment on some of the most exciting things that will happen in the rest of the year in the U.S.

所以也許斯文，你可以評論一下美國今年剩餘時間裡將發生的一些最令人興奮的事情。

Yes. Thank you, Kare. So for AJOVY, we expect a steady development that is based on improved market access and improved market share. For AUSTEDO, we see a pretty good development now with our TV campaign and the patient activation in script count, we had within the quarter from January to March, a significant step-up in TRxs. So we expect AUSTEDO to grow throughout this year towards its guidance target. In generics, of course, we had in the first quarter now a significant step down in TRUVADA and Atripla. We also had, as a reminder, last year in Q1, a loading effect for EpiPen because the approval of the COVID vaccine led to an EpiPen spike that we've seen in 2021. So that didn't repeat in 2022. But for generics, the outlook, of course, is that we are not independent of the macro environment in the U.S. with the price deflation, but we have now launched Revlimid in March 2022, so just 4 weeks ago. And that will continue to build up revenues for us throughout the year within the settlement framework that we have with [BMS] and then we have a couple of other products where we still expect or hope for approval from the FDA and generics. The most important one for us is Forteo which would be also a significant contributor to our sales in 2022.

是的。謝謝你，凱爾。因此，對於 AJOVY，我們預計基於改善市場准入和提高市場份額的穩定發展。對於 AUSTEDO，我們現在看到了一個非常好的發展，我們的電視活動和腳本數量的患者激活，我們在 1 月至 3 月的季度內實現了 TRxs 的顯著提升。因此，我們預計 AUSTEDO 將在今年全年朝著其指導目標發展。當然，在仿製藥方面，我們在第一季度現在在 TRUVADA 和 Atripla 方面出現了顯著下降。提醒一下，去年第一季度，我們還對 EpiPen 產生了加載效應，因為 COVID 疫苗的批准導致 EpiPen 飆升，我們在 2021 年看到了這種情況。所以這種情況在 2022 年沒有重複。但對於仿製藥，當然，前景是我們並沒有獨立於美國的宏觀環境與價格通縮，但我們現在已經在 2022 年 3 月推出了 Revlimid，所以就在 4 週前。在我們與 [BMS] 的結算框架內，這將繼續為我們全年增加收入，然後我們還有一些其他產品，我們仍然期望或希望獲得 FDA 和仿製藥的批准。對我們來說最重要的是 Forteo，它也將成為我們 2022 年銷售額的重要貢獻者。

So the bottom line is that we expect a gradual development throughout the year and the buildup of revenues towards the end of the year.

因此，底線是我們預計全年將逐步發展，並在年底前增加收入。

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

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

Perhaps for Eli, just wanted to ask a question around the operating profit impact from the reduction to your top line guidance, owing to currency, specifically, and then thinking about the combined impact of currency assuming that there is one combined with lower expected profit contribution from COPAXONE, which is not insignificant still. Trying to think about what some of the potential offsets to those may be that enabled you to still maintain prior adjusted EBITDA and free cash flow guidance? Or should we be thinking a little bit more along the lines that these numbers may be a little bit more skewed towards the lower end of the range versus where they currently stand? And then I had a follow-up question for you, Kare, on the legal settlement provision this quarter. Just want to get a sense of where or what the current balance sheet accrual is for legal settlements and loss contingencies. I'm assuming it's over $3 billion now. I'm just trying to get a sense based on some of the settlements that have been entered into recently, which seem to be along similar lines to what we've seen really over the last year or so, why we've seen a fairly significant step-up in the accrual related to potential settlements on opioid litigation.

也許對 Eli 來說，只是想問一個關於減少對您的頂線指導的營業利潤影響的問題，特別是由於貨幣，然後考慮貨幣的綜合影響，假設有一個與較低的預期利潤貢獻相結合來自 COPAXONE，這仍然不是微不足道的。嘗試考慮哪些潛在的抵消可能使您仍保持先前調整後的 EBITDA 和自由現金流指導？或者我們是否應該更多地考慮這些數字可能更偏向范圍的下端而不是它們目前的位置？然後我有一個後續問題要問你，Kare，關於本季度的法律和解條款。只是想了解當前資產負債表應計在哪里或什麼是合法結算和損失意外事件。我假設它現在超過 30 億美元。我只是想根據最近進入的一些定居點來了解一下，這些定居點似乎與我們在過去一年左右看到的情況相似，為什麼我們看到了一個相當與阿片類藥物訴訟的潛在和解相關的應計費用顯著增加。

Thanks, Elliot. So Eli will talk first about the currency elements.

謝謝，艾略特。所以Eli會先講貨幣元素。

Yes. Thanks, Elliot, for the question. So we still stick to what we said in February in terms of the margin, which means that according to our long-term financial targets with the baseline of '19 onwards to total [250] basis points up to the 28% OP which is leading us to top this year as well, like 0.7% year-over-year on gross margin. And the flow-through will be going to the OP the part of those, I would say, elements impacting our revenue. As you know, we're also operating in those countries that actually we are getting kind of less on the expenses. So it's kind of not offsetting all of this one. I would say, not the full offset. But because of our ongoing activities, mainly on [COG] reduction, and we see it quarter-over-quarter and the fact that we remove certain fixed costs, mainly with manufacturing footprint from our portfolio, and we see now kind of a benefit that already help us to offset those things. So all in all, if you look on our current midpoint on the new guidance, we should land at the same more or less margin that we talked already in Q1, around 27.5% to 27.7% for the year.

是的。謝謝艾略特的問題。因此，我們仍然堅持我們在 2 月份所說的利潤率，這意味著根據我們的長期財務目標，從 19 年開始到總 [250] 個基點，最高 28% OP，這是領先的我們今年也達到頂峰，例如毛利率同比增長 0.7%。我想說的是，影響我們收入的因素中的一部分將流向 OP。如您所知，我們也在那些實際上我們獲得的費用較少的國家開展業務。因此，這並不能抵消所有這些。我會說，不是完整的偏移量。但是由於我們正在進行的活動，主要是減少 [COG]，我們看到它環比下降，而且我們消除了某些固定成本，主要是我們的投資組合中的製造足跡，我們現在看到了一種好處已經幫助我們抵消了這些東西。所以總而言之，如果你看看我們目前對新指引的中點，我們應該會達到我們在第一季度已經談到的或多或少的利潤率，全年約為 27.5% 至 27.7%。

Thank you, Eli. And on the legal provision, the legal provision for the opioid litigation is now at USD 2.6 billion, which is an increase of $1.1 billion versus the last quarter. And it's really the result of a holistic assessment of what's the effect of the settlements we've done so far, what's the most likely outcome based on our current negotiations. So you should see there's a holistic assessment that we do. And of course, there's a lot of detailed factors in there. There's products in there of various volumes, there's cash in there over various periods and so on. So that's really our best guess as we speak.

謝謝你，伊萊。在法律規定方面，阿片類藥物訴訟的法律規定目前為 26 億美元，比上一季度增加了 11 億美元。這實際上是對我們迄今為止所做的和解的影響進行全面評估的結果，根據我們目前的談判，最有可能的結果是什麼。因此，您應該看到我們進行了整體評估。當然，其中有很多詳細的因素。裡面有各種數量的產品，裡面有不同時期的現金等等。所以這確實是我們說話時的最佳猜測。

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

下一個問題來自 Bernstein 的 Ronny Gal。

I'll ask 2. The first about the (inaudible) Risperidone, can you just talk a little bit about what the issues here Risperidone is molecule with known efficacy to the formulation, is it manufacturing? Is it lack of preclinical data, where are the gaps? And the second one about the material contribution from adalimumab in 2023. Is this something you're going to see? Or is it more for 2024 contribution? And probably my last call, my question, I want to sneak one in. Eli, if you can tell us what this $2.6 billion in provision for the opioid settlement, mean in terms of undiscounted dollars, essentially, there's some discounting assumption thrown in there about how long it will take to pay, but how much is kind of like the non-discounted dollar value it represents?

我會問 2. 第一個關於（聽不清的）利培酮，你能談談這裡的問題嗎 利培酮是對配方具有已知功效的分子，它是製造的嗎？是缺乏臨床前數據，差距在哪裡？第二個是關於 2023 年阿達木單抗的物質貢獻。這是你會看到的嗎？還是 2024 年的貢獻更多？也許我的最後一個電話，我的問題，我想偷偷溜進去。Eli，如果你能告訴我們這 26 億美元用於阿片類藥物和解的準備金，就未貼現的美元而言意味著什麼，基本上，那裡有一些貼現假設大約需要多長時間才能支付，但它所代表的非貼現美元價值有多少？

Thank you for those 3 questions, Ronny, and good luck in your future career. So the first one, the CRL. I can't tell you all the details, but I can tell you it has nothing to do with, you could say, efficacy and safety. We have very, very good efficacy data, very good safety data. We are very confident that the principle works very, very well. But it's to do with some details around how you could say the whole execution of the clinical trials have been done and some details there, which we are confident that we can address and correct and communicate back to FDA within maximum 6 months. And then we expect the review time of 6 months. So we still have high trust in the fact that we can get the product approved at the end of the day.

感謝您提出這 3 個問題，Ronny，祝您在未來的職業生涯中好運。所以第一個，CRL。我不能告訴你所有的細節，但我可以告訴你，這與你可以說的有效性和安全性無關。我們有非常非常好的療效數據，非常好的安全性數據。我們非常有信心，該原則非常非常有效。但這與您如何說臨床試驗的整個執行已經完成的一些細節以及那裡的一些細節有關，我們相信我們可以在最多 6 個月內解決和糾正並與 FDA 溝通。然後我們預計審核時間為 6 個月。所以我們仍然非常相信我們可以在一天結束時讓產品獲得批准。

Then on Humira, Sven, will you handle that question?

那麼關於修美樂，斯文，你會處理這個問題嗎？

Yes. Thank you, Kare, and congratulations Ronny to your new job. So the question was if adalimumab biosimilar becomes a material event for us in 2023 or 2024? I believe this is dependent on the market access strategy of payers, how they think about the switchover between AbbVie to the biosimilar offering. And that can happen in the summer of 2023 given that there are many now available options or it is pushed out to 2024 depending on the contracting strategy of the payers. So of course, we are committed to come to market in 2023 in the summer and also to have a broad offering. But I believe payers will look in a couple of factors to come up with their strategy. Of course, one is the product feature, then the reliability of supplies of all the companies coming to market because that is a significant volume market in the U.S. And of course, AbbVie is able to cover 100% of the volume, then it will be driven by, of course, attractive prices. And then, as I said, the experience to create a pull-through in the market itself once you have contracted. And I think these 4 factors will define the market access strategy overall. And once we have the contracting right, at that moment -- only at that moment, we can say whether it is a material event for us in 2023 or in 2024. But it was for sure be one in 2024.

是的。謝謝你，Kare，並祝賀 Ronny 得到你的新工作。所以問題是，阿達木單抗生物類似藥是否會在 2023 年或 2024 年成為我們的重大事件？我相信這取決於付款人的市場准入策略，以及他們如何看待艾伯維（AbbVie）向生物仿製藥產品的轉換。這可能會在 2023 年夏天發生，因為現在有很多可用的選擇，或者根據付款人的合同策略推遲到 2024 年。因此，當然，我們致力於在 2023 年夏季上市，並提供廣泛的產品。但我相信付款人會考慮幾個因素來製定他們的策略。當然，一個是產品特性，然後是所有進入市場的公司的供應可靠性，因為那是美國的一個大容量市場。當然，AbbVie 能夠覆蓋 100% 的容量，那麼它將是當然，價格誘人。然後，正如我所說，一旦你簽約，就可以在市場上創造一個突破口。我認為這 4 個因素將總體上定義市場准入策略。一旦我們擁有承包權，在那一刻——只有在那一刻，我們才能說這對我們來說是 2023 年還是 2024 年的重大事件。但肯定是 2024 年的事件。

Yes. So thanks for that answer, Sven. And of course, Ronny, I would say I would be disappointed if it's not a material event in '23 because, of course, we are aiming at launching for the settlement date. And we are happy, of course, that the Alvotech product is already being sold in Europe, so it's in the marketplace. So we have, you could say, high confidence that, that will work out.

是的。所以謝謝你的回答，斯文。當然，羅尼，如果這不是 23 年的重大事件，我會說我會很失望，因為當然，我們的目標是在結算日期推出。當然，我們很高興 Alvotech 產品已經在歐洲銷售，所以它在市場上。因此，您可以說，我們非常有信心，這會奏效。

On the last question to Eli, just inspiration for you, the settlements we've done, as you've seen, had basically nearly all of them being something like 13- or 15-years payment. But Eli, you can comment a bit more on the technical details.

關於 Eli 的最後一個問題，只是對你的啟發，正如你所見，我們所做的和解基本上幾乎所有的都是 13 年或 15 年的付款。但是 Eli，您可以對技術細節發表更多評論。

Yes. So Ronny, you can understand that it's a very, I would say, detailed detail because there are certain layers on what we already settled and the rest of the things. But all in all, it's an average between 13 to 15 years. We're using our company WACC, and this one is kind of a discounting, but we need to understand that most of the discounting related to the cash and because of those players that we already settled a part of them already happening in the first years and part of the one that we didn't settle for longer years. So it really depends. It's not really a pure linear. And also, we need to understand that embedded their part of the fees and as well part of the element of the product. So -- but all in all, it's like between 13 to 15 years discounted the net of 2.6%.

是的。所以羅尼，你可以理解這是一個非常詳細的細節，因為我們已經解決的問題和其他事情有一定的層次。但總而言之，平均在 13 到 15 年之間。我們正在使用我們公司的 WACC，這是一種折扣，但我們需要了解大部分折扣與現金有關，並且因為我們已經解決了這些玩家，其中一部分已經在第一年發生和我們沒有解決更長時間的一部分。所以這真的取決於。它不是真正的純線性。而且，我們需要了解嵌入了他們的部分費用以及產品元素的一部分。所以——但總而言之，這就像 13 到 15 年之間折現了 2.6% 的淨值。

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

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

First, Kare, when you think of the operating margin expanding beyond 28% over time, where will that mostly come from? Higher-margin products, greater manufacturing efficiencies, lower spend in certain areas? Just qualitatively, how you're thinking about that? How much higher that could potentially go? Could it get into the 30s in a few years? And then with AUSTEDO, just talk a bit more about how you're confident you could get to the full year guidance of $1 billion? Where will most of the acceleration come from? It does seem like it will be challenging at this point.

首先，Kare，當您考慮到營業利潤率會隨著時間的推移超過 28% 時，這主要來自哪裡？更高利潤的產品、更高的製造效率、更低的某些領域的支出？只是定性的，你是怎麼想的？這可能會高多少？幾年後能進入30年代嗎？然後與 AUSTEDO，多談談你如何有信心達到 10 億美元的全年指導？大部分的加速度來自哪裡？在這一點上，它似乎確實具有挑戰性。

Thanks for those 2 questions. I'll answer the first one and Sven will take the second one. So the operating margin expansion will primarily come from a combination of gross margin improvement and you could say, product portfolio improvement, but it's really basic product portfolio improvement. So it's also improving the manufacturing cost of product families by consolidation. So it's not that we're expecting a major shift, let's say, from generics to specialty. It's more the fact that we can, within all the product groups we have, keep on optimizing. And that goes for the manufacturing footprint. As you know, last couple of years -- last 4 years, we moved from 80 manufacturing sites down to 50. Right now, we are in the process of moving down another 10 sites to around 40 manufacturing sites. And we'll keep on optimizing and we'll also keep on optimizing our product portfolios. So all in all, the majority of the benefit will come from gross margin improvements, and there will be limited improvements on, you could say, the commercial cost structure because that's relatively lean by now. And we don't see the same magnitude of improvements.

感謝這兩個問題。我會回答第一個問題，Sven 會回答第二個問題。因此，營業利潤率的擴大將主要來自毛利率的提高和產品組合的改善，但這實際上是基本的產品組合改善。因此，它還通過整合提高了產品系列的製造成本。因此，我們並不期待從仿製藥到專業的重大轉變。更重要的是，我們可以在我們擁有的所有產品組中繼續優化。這也適用於製造足跡。如您所知，過去幾年——過去 4 年，我們從 80 個生產基地減少到 50 個。現在，我們正在將另外 10 個生產基地轉移到大約 40 個生產基地。我們將繼續優化，我們還將繼續優化我們的產品組合。總而言之，大部分收益將來自毛利率的提高，而商業成本結構的改善將有限，因為目前這種結構相對精簡。而且我們沒有看到同樣幅度的改進。

If you then speculate how much improvement can you see, then it's my experience that when you haven't reached sort of the world-class situation on your manufacturing, then you can do something like 50 to 100 basis points per annum. And we will get back to you with some more firm targets in the coming year on what our long-term financial target for the operating margin will be. On the AUSTEDO, maybe Sven, you can give some details on how we see AUSTEDO developing and why we are confident that we can meet the $1 billion sales guidance.

如果你然後推測你能看到多少改進，那麼根據我的經驗，當你的製造業還沒有達到世界級的水平時，你可以每年提高 50 到 100 個基點。我們將在來年向您提供一些更堅定的目標，說明我們的營業利潤率的長期財務目標是什麼。關於 AUSTEDO，也許是 Sven，您可以詳細說明我們如何看待 AUSTEDO 的發展，以及為什麼我們有信心達到 10 億美元的銷售指導。

Yes. Our guidance implies that we have a growth in sales of roundabout 30% versus 2021. Our script count went up in quarter-over-quarter by 27%. Also when you harmonize over 2 quarters the sales to eliminate the effect of the spec buying and the donut hole in Q1 and Q4 of last year, we also see that the sales are absolutely on track with roundabout plus 32% over these 2 quarters. And for that reason, I'm quite confident that we can get to $1 billion sales for AUSTEDO in North America.

是的。我們的指導意味著我們的銷售額與 2021 年相比增長了大約 30%。我們的劇本數量環比增長了 27%。此外，當您協調兩個季度以上的銷售以消除去年第一季度和第四季度的規格購買和甜甜圈洞的影響時，我們還看到銷售絕對走上正軌，在這兩個季度中迴旋加 32%。出於這個原因，我非常有信心，AUSTEDO 在北美的銷售額可以達到 10 億美元。

And maybe we should just add in the sort of known fact that, of course, one of the key things driving increased scripts and volume for AUSTEDO is tardive dyskinesia. There are only 2 products approved for tardive dyskinesia in United States. AUSTEDO is one of them. And right now, we are estimating that's significantly less than 10% of the population or the patient population suffering from tardive dyskinesia are getting therapy. So there's a huge unmet potential among the 500,000 suffering from tardive dyskinesia in the United States. So there's a huge unmet medical need there, which we will be more than happy to, of course, satisfy.

也許我們應該添加一個已知事實，當然，推動 AUSTEDO 腳本和數量增加的關鍵因素之一是遲發性運動障礙。在美國祇有 2 種產品獲准用於遲發性運動障礙。 AUSTEDO 就是其中之一。現在，我們估計只有不到 10% 的人口或患有遲發性運動障礙的患者正在接受治療。因此，在美國 500,000 名患有遲發性運動障礙的患者中存在著巨大的未開發潛力。所以那裡有一個巨大的未滿足的醫療需求，我們當然很樂意滿足。

And then last question comes from the line of Jason Gerberry from Bank of America.

最後一個問題來自美國銀行的 Jason Gerberry。

This is Bhavin Patel on for Jason Gerberry. So my first question is on U.S. Humira. We're hearing a number of players increasingly talk about the importance of supply commitments in a market like this. Could you talk about your strategy and the percent of the market a supplier needs to commit to providing the biosimilar to? And then on generic Revlimid, could you speak to the extent that Teva could have preferential volume position versus other generics in 2023 or beyond? And then finally, if I could fit one last in. I'm just wondering if you could provide some insight as to why AUSTEDO sales are so volatile quarter-to-quarter? It looks like $154 million last quarter versus $282 million this quarter. Is it driven by the stocking patterns or phasing on patient assistance program impact?

這是 Jason Gerberry 的 Bhavin Patel。所以我的第一個問題是關於美國修美樂。我們聽到許多參與者越來越多地談論供應承諾在這樣的市場中的重要性。您能否談談您的戰略以及供應商需要承諾提供生物仿製藥的市場百分比？然後在仿製藥 Revlimid 上，您能否談談梯瓦（Teva）在 2023 年或以後可能比其他仿製藥擁有優先銷量地位的程度？最後，如果我能適應最後一個。我只是想知道您是否可以提供一些關於為什麼 AUSTEDO 銷售季度間波動如此之大的見解？上個季度看起來為 1.54 億美元，而本季度為 2.82 億美元。它是由庫存模式驅動還是分階段對患者援助計劃的影響？

Thank you for those 3 questions. I think that Sven will do the majority of the answers here. I'll just say that in general, when you talk about biosimilar products or for that matter, competing biologics, then, of course, it's always important to have some firm commitments on supplies. And if we look at what -- where we have been competing recently with the biosimilar to Rituxan [without] TRUXIMA then we have been targeting from the beginning that we would have double-digit volume share. And right now, we have around 1/4 of the market. And that's really what we've been going for. And you can see some patterns of course, in what's realistic to get when you have a multiplayer competitive situation. And from that, you can sort of deduct a range of volumes that you need.

謝謝你的這3個問題。我認為 Sven 會在這裡回答大部分問題。我只想說，一般來說，當您談論生物仿製藥產品或與之相關的競爭生物製劑時，當然，在供應上做出一些堅定的承諾總是很重要的。如果我們看看我們最近在哪裡與 Rituxan [沒有] TRUXIMA 的生物仿製藥競爭，那麼我們從一開始就瞄准我們將擁有兩位數的銷量份額。而現在，我們擁有大約 1/4 的市場份額。這就是我們一直追求的目標。你當然可以看到一些模式，當你有一個多人競爭的情況時，這是現實的。從中，您可以扣除您需要的一系列數量。

But I will leave that question and the other questions for you, Sven, to answer.

但我會把這個問題和其他問題留給斯文，讓你回答。

Yes. The first one was on the supply commitment supply chain question regarding Humira biosimilar. So our partner is here (inaudible), they do the drug substance manufacturing and also the drug product manufacturing, and we are the commercial partner in the U.S. This is how it is set up. Humira Alvotech is already approved in the European Union, and it will be launched before we come here to the U.S. market. That gives us some confidence that the supply chain reliability should be there and that we have a good understanding about how much volume we can supply to the U.S. market. There's, of course, also a plan about how volume will be ramped up over time for this product. So we have clarity in that aspect as well. And then the volume commitment that we can do in here for the U.S. is dependent on our market access and contracting strategy. So that will be something that we would balance for the product launch next year, but we are quite confident that we will be in shape for this product launch.

是的。第一個是關於修美樂生物仿製藥的供應承諾供應鏈問題。所以我們的合作夥伴在這裡（聽不清），他們進行原料藥製造和藥品製造，我們是美國的商業合作夥伴。這就是它的設置方式。 Humira Alvotech 已經在歐盟獲得批准，它將在我們來到美國市場之前推出。這讓我們相信供應鏈的可靠性應該存在，並且我們對我們可以向美國市場供應多少數量有很好的了解。當然，還有一個關於如何隨著時間的推移增加該產品的銷量的計劃。所以我們在這方面也很清楚。然後，我們可以在這里為美國做的數量承諾取決於我們的市場准入和承包戰略。因此，這將是我們為明年的產品發布而平衡的東西，但我們非常有信心，我們將為這個產品的發布做好準備。

So the other question was on the AUSTEDO sales volatility. We talked about that before. Of course, we had the spec buying effect in Q4 of last year, and then you always have an inventory, let's say, a reduction on the wholesaling channel in Q1 this year. We've seen this every year. In addition, there is the donut hole effect that comes in, in January, February of this year, and that leads to the sales volatility of AUSTEDO. Overall, as I said before, the script count is on track and is actually growing very gradually, according to our plans. So for that reason, we are confident that we have reached our sales target. And I think there was a third question but I don't...

所以另一個問題是關於 AUSTEDO 的銷售波動。我們之前談過這個。當然，我們在去年第四季度就有了規格購買效應，然後你總是有庫存，比如說今年第一季度批發渠道的減少。我們每年都見過這種情況。此外，今年 1 月、2 月還有甜甜圈洞效應，這導致了 AUSTEDO 的銷售波動。總體而言，正如我之前所說，根據我們的計劃，劇本數量正在走上正軌，並且實際上正在非常緩慢地增長。因此，我們有信心達到我們的銷售目標。我認為還有第三個問題，但我不...

Yes, there was a Revlimid where we have a volume-based settlement, and you can correct me if I'm wrong, Sven, but the way I remember it, there's a volume limitation this year but also in '23 and '24. And then in '25, that's no longer the case. And there will also be other competitors, which, from what I know, also have some kind of volume restriction. So we'll probably see all-out competition in '25, and we'll see some, you could say, volume limitations for us in '23 and '24.

是的，有一個 Revlimid，我們有一個基於數量的結算，如果我錯了，你可以糾正我，Sven，但我記得，今年有數量限制，23 年和 24 年也是如此。然後在 25 年，情況不再如此。而且還會有其他競爭對手，據我所知，它們也有某種數量限制。所以我們可能會在 25 年看到全面的競爭，我們會在 23 年和 24 年看到一些，你可以說，我們的數量限制。

Yes, that's correct.

對，那是正確的。

So thank you for those questions.

所以謝謝你的這些問題。

Thank you. That does conclude our question-and-answer session. Please continue with your closing remarks.

謝謝你。這確實結束了我們的問答環節。請繼續您的結束語。

Thank you, everyone, for listening in. It was a pleasure, and we'll see you next quarter. Bye-bye.

謝謝大家的收聽。很高興，我們下個季度再見。再見。

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

謝謝你。這確實結束了我們今天的電話會議。感謝您的參與。您現在可以全部斷開連接。