Teva Pharmaceutical Industries Ltd (TEVA) 2018 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Teva first quarter 2018 financial results.

女士們，先生們，感謝你們的支持，歡迎來到梯瓦 2018 年第一季度財務業績。

(Operator Instructions) I must also advise you, the call is being recorded today, Thursday, the 3rd of May, 2018.

（操作員說明）我還必須告訴您，今天，2018 年 5 月 3 日星期四，通話正在錄音。

I would like to turn the conference over to your first speaker today, Kevin Mannix, Senior Vice President, Head of Investor Relations.

我想將今天的會議轉交給您的第一位發言人，高級副總裁兼投資者關係主管凱文·曼尼克斯（Kevin Mannix）。

Please go ahead, sir.

請繼續，先生。

Thank you, Steve, and thank you, everyone for joining us today to discuss Teva's first quarter 2018 financial results.

謝謝史蒂夫，也謝謝大家今天加入我們討論梯瓦公司 2018 年第一季度的財務業績。

Earlier this morning, we issued our press release detailing our results for the quarter and year.

今天早上早些時候，我們發布了我們的新聞稿，詳細說明了我們的季度和年度業績。

A copy of the press release as well as the copy of the slides being presented on this call can be found on our website at www.tevapharm.com as well as on our Teva Investor Relations app.

可以在我們的網站 www.tevapharm.com 以及我們的梯瓦投資者關係應用程序上找到新聞稿的副本以及本次電話會議上展示的幻燈片的副本。

Our discussion today includes certain non-GAAP measures as defined by the SEC.

我們今天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。

Management uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the company's operations to better understand its business.

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，以更好地了解其業務。

Further, management believes the inclusion of non-GAAP financial measures provides meaningful supplementary information to and facilitates analysis by investors in evaluating the company's financial performance, results of operations and trends.

此外，管理層認為，納入非公認會計原則財務措施為投資者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。

Reconciliation of GAAP to non-GAAP measures are available in our earnings release and in today's presentation.

GAAP 與非 GAAP 措施的對賬可在我們的收益發布和今天的演示文稿中找到。

Today, Kåre Schultz, our Chief Executive Officer, will open the call with some remarks on our results, recent events and outlook for 2018.

今天，我們的首席執行官 Kåre Schultz 將在電話會議開始時就我們的業績、近期事件和 2018 年展望發表一些評論。

Mike McClellan, our Chief Financial Officer, will review the first quarter financial results in more detail and discuss additional assumptions around our 2018 outlook.

我們的首席財務官 Mike McClellan 將更詳細地審查第一季度的財務業績，並討論圍繞我們 2018 年展望的其他假設。

I'd also like to note that on the call with us and available during the Q&A is Brendan O'Grady, Teva's Head of North America Commercial.

我還想指出，在與我們通話並在問答期間有空的是 Teva 北美商業主管 Brendan O'Grady。

And with that, I'll now turn the call over to Kåre.

有了這個，我現在將把電話轉給 Kåre。

Kåre, if you would, please.

Kåre，如果你願意，請。

Good morning, or good afternoon to all of you, and thanks for calling in.

大家早上好，或者下午好，感謝您的來電。

We had a strong start to 2018.

我們在 2018 年有一個強勁的開端。

The sales in the first quarter came out above $5 billion, USD 5.1 billion.

第一季度的銷售額超過 50 億美元，即 51 億美元。

And you will have seen that our earnings per share also came out strong.

你會看到我們的每股收益也很強勁。

So the GAAP EPS came out at $1.03 and the non-GAAP EPS came out at $0.94.

因此，GAAP 每股收益為 1.03 美元，非 GAAP 每股收益為 0.94 美元。

The free cash flow was also strong at USD 1.9 billion, and of course, there were several factors influencing this.

自由現金流也很強勁，達到 19 億美元，當然，有幾個因素影響了這一點。

One of the factors was the fact that our restructuring program is on schedule.

其中一個因素是我們的重組計劃如期進行。

It's doing very nice.

它做得很好。

I'll get back with more details about that.

我會回來提供有關此的更多詳細信息。

It's of course also important that our generic business in a -- is in a good balance.

當然，我們在通用業務中的平衡也很重要。

What I mean by that is that, as you all know, there will be products that are dropping off of the end of the lifecycle in generics and where prices are coming down.

我的意思是，正如你們都知道的那樣，在仿製藥的生命週期結束時，會有一些產品正在下降，價格也會下降。

And then there'll be products that we are launching and that are coming in at healthy profitability in the beginning of the pipeline.

然後我們將推出一些產品，這些產品在管道開始時將以健康的盈利能力進入。

And we've seen a good level of approvals and launches both in the U.S., Europe and in the growth markets.

我們在美國、歐洲和成長型市場都看到了良好的批准和推出水平。

COPAXONE is maintaining its share very nicely in the U.S. I'll give you some details on that.

COPAXONE 在美國的市場份額保持得非常好。我會告訴你一些細節。

But it's really very steady at around 85% of the 40-milligram marketplace, and also in Europe, it's looking good.

但它確實非常穩定，在 40 毫克市場的 85% 左右，而且在歐洲，它看起來也不錯。

AUSTEDO, that we launched last year, first for Huntington's disease; chorea; and Huntington's disease, the movement disorder; and then for tardive dyskinesia, another type of moving disorder, is continuing to grow nicely, and we see continuous growth in patients and also in revenues.

AUSTEDO，我們去年推出的，首先針對亨廷頓病；舞蹈病；和亨廷頓氏病，運動障礙；然後對於遲發性運動障礙，另一種類型的運動障礙，正在繼續良好增長，我們看到患者和收入都在持續增長。

And as a consequence of all these past developments, we have been able to reduce our debt, and the net debt is now down below $30 billion, which we see as a positive sign on our ability to keep on reducing debt also going forward.

由於所有這些過去的發展，我們已經能夠減少我們的債務，淨債務現在低於 300 億美元，我們認為這是我們繼續減少債務能力的一個積極信號。

As a consequence of the better performance in the first quarter, we have raised our guidance for the full year.

由於第一季度的表現更好，我們提高了全年的指導。

So we are now guiding that the non-GAAP EPS for the full year will be between $2.40 and $2.65.

因此，我們現在指導全年的非公認會計原則每股收益將在 2.40 美元至 2.65 美元之間。

And we've also increased the guidance for free cash flow, and it's come up from $2.6 billion to $2.8 billion by $400 million to between $3.0 billion and $3.2 billion.

我們還增加了對自由現金流的指導，從 26 億美元增加到 28 億美元，增加了 4 億美元到 30 億美元到 32 億美元之間。

In terms of GAAP and non-GAAP, there's a few differences on the revenue line.

在 GAAP 和非 GAAP 方面，收入線上存在一些差異。

Of course, that is no big deal.

當然，這沒什麼大不了的。

It's the same, and we have a development here from '17 to '18 where we have a reduction in revenues.

也是一樣，從 17 年到 18 年，我們的收入有所減少。

And we'll discuss it a bit later.

我們稍後會討論它。

But it's primarily a combination of businesses that we sold off and of some decline in the COPAXONE and U.S. generic business that we have already commented on in previous quarters.

但這主要是我們出售的業務的組合，以及我們在前幾個季度已經評論過的 COPAXONE 和美國仿製藥業務的一些下降。

On the operating income, you can see that there is slight difference between the non-GAAP and the GAAP in the sense that in the first quarter of '18, our GAAP operating income was $1.5 billion and the non-GAAP was $1.4 billion.

在營業收入方面，您可以看到非 GAAP 和 GAAP 之間存在細微差異，因為在 18 年第一季度，我們的 GAAP 營業收入為 15 億美元，非 GAAP 為 14 億美元。

And the same thing then goes down to net income where the GAAP is slightly higher than the non-GAAP.

然後同樣的事情下降到GAAP略高於非GAAP的淨收入。

But basically, we made, on a non-GAAP basis, $1 billion in net income in the first quarter, and that is what results in the $0.94 per share.

但基本上，根據非公認會計原則，我們第一季度的淨收入為 10 億美元，這就是每股 0.94 美元的結果。

So all in all, we're very satisfied with that, and we're also very satisfied with the total cash generated, which, in the first quarter, was USD 2.5 billion.

總而言之，我們對此非常滿意，我們對第一季度產生的總現金為 25 億美元也非常滿意。

Now one of the elements that has been driving this development is the restructuring program that we announced back in the middle of December.

現在，推動這一發展的因素之一是我們在 12 月中旬宣布的重組計劃。

And as you probably remember, the total target for the program in terms of reduction in the spend base is USD 3 billion.

您可能還記得，該計劃在減少支出基數方面的總目標是 30 億美元。

And it's our plan to realize half of that in the current year and the full amount by the end of 2019.

我們計劃在今年實現一半，到2019年底實現全部。

And we are very much on track with that.

我們在這方面做得非常好。

And one of the key elements is, of course, the reduction in the total manpower of the company.

當然，其中一個關鍵因素是公司總人力的減少。

And you might remember that, compared to the end of the third quarter, which was the basis for our restructuring plan, we had a plan to reduce the headcount by some 14,000 persons.

您可能還記得，與作為我們重組計劃的基礎的第三季度末相比，我們計劃裁員約 14,000 人。

And in the first quarter, we see here that we come out at a number which is around 46,000 in total, and that is roughly 6,200 less than when we started the plan.

在第一季度，我們在這裡看到我們的總數約為 46,000，這比我們開始計劃時減少了大約 6,200。

So we are on track to achieve exactly the reductions we planned and that we set out for.

因此，我們正在按計劃準確實現我們計劃和著手的減排目標。

If anything, it's going slightly faster than planned, but it's not a major deviation.

如果有的話，它會比計劃的稍微快一點，但這並不是一個重大的偏差。

But it does contribute a little bit to us having slightly lower cost than we were expecting in the first quarter.

但它確實對我們有一點貢獻，成本略低於我們在第一季度的預期。

So that's a positive.

所以這是積極的。

We're also doing a lot of changes to our manufacturing footprint, optimizing it, consolidating sites and divesting or closing redundant sites.

我們還對我們的製造足跡進行了很多改變，優化它，整合站點並剝離或關閉冗餘站點。

And so far, we have announced 10 plant closures since December since we announced the restructuring plan.

到目前為止，自我們宣布重組計劃以來，我們已宣布關閉 10 家工廠。

On the consolidation side, we're also consolidating all other activities, such as R&D sites, headquarter sites, office locations and so on.

在整合方面，我們還整合了所有其他活動，例如研發地點、總部地點、辦公地點等。

So there's a massive activity ongoing, but it's all proceeding according to plan.

因此，正在進行大規模的活動，但一切都在按計劃進行。

And I'm very happy about the development on our restructuring plan overall.

我對我們整體重組計劃的進展感到非常高興。

If we look at the revenue side, then of course, U.S. generics has been a big discussion topic and a big unknown for quite a while with a lot of changes happening.

如果我們從收入方面來看，當然，美國仿製藥在很長一段時間內一直是一個很大的討論話題和一個很大的未知數，發生了很多變化。

I'm happy to report to you that when it comes to the volume, which is a starting point of any business, of course, then we see a very strong performance in the first quarter.

我很高興向您報告，當談到數量時，這是任何業務的起點，當然，我們看到第一季度的表現非常強勁。

We actually had more than 0.5 billion of scripts in the U.S. for our generic business, 583 million actually, around 15% volume share on the U.S. generic prescriptions.

實際上，我們的仿製藥業務在美國擁有超過 5 億個腳本，實際上是 5.83 億個，約占美國仿製藥處方量的 15%。

So that's, of course, positive.

所以這當然是積極的。

I know that you like to ask about the pricing, and I know you all remember, I told you that I wouldn't comment on it anymore with any specific numbers because I thought the generic industry had been doing a bad job on pricing and have been part of driving down prices.

我知道你們喜歡問定價，我知道你們都記得，我告訴過你們我不會再用任何具體數字評論它，因為我認為仿製藥行業在定價方面做得不好，並且已經是壓低價格的一部分。

I can tell you that we are actually working on optimizing our portfolio with a strong focus on profitability.

我可以告訴你，我們實際上正在努力優化我們的投資組合，重點關注盈利能力。

We're doing it in close collaboration with our key customers in a positive environment, ensuring stability in supplies and making sure that we can live up to the expectations from patients.

我們在積極的環境中與我們的主要客戶密切合作，確保供應的穩定性，並確保我們能夠不辜負患者的期望。

But it does, of course, have the effect that we -- in our forecast, we see an adjustment of the total business we have in the U.S. That was part of what we announced at the beginning of the year where we said U.S. generics would probably sell around USD 4 billion for the year, and we still expect that.

但當然，它確實會影響我們——在我們的預測中，我們看到我們在美國的總業務發生了調整。這是我們在年初宣布的部分內容，我們說美國仿製藥將今年可能會賣出 40 億美元左右，我們仍然預計這一點。

One of the reasons why this is possible is, of course, all the new launches, and we are still, by far, the biggest in volume share but also, by far, the biggest in the number of product applications that are sitting with the FDA, also in terms of tentative approvals and first-to-files.

這可能的原因之一當然是所有新產品的發布，到目前為止，我們仍然是最大的數量份額，而且到目前為止，與FDA，也在初步批准和首次申請方面。

So we think we have a very strong starting point for stabilizing and expanding profitability in our U.S. generics business.

因此，我們認為我們有一個非常好的起點來穩定和擴大我們美國仿製藥業務的盈利能力。

You can see here on the slide the 10 products that we launched in the first quarter.

您可以在幻燈片上看到我們在第一季度推出的 10 款產品。

And this is kind of the run rate we want to have and we need to have but also the one that we are expecting to have, broadly speaking, going forward so that every year, we can put enough new generic products into the marketplace to stabilize our U.S. generics business.

這是我們想要的運行速度，我們需要，但也是我們期望擁有的運行速度，從廣義上講，向前發展，以便每年，我們可以將足夠的新仿製藥產品投放市場以穩定我們的美國仿製藥業務。

Another important element in our sales is, of course, COPAXONE.

當然，我們銷售中的另一個重要元素是 COPAXONE。

That's also nothing new.

這也不是什麼新鮮事。

It's been also reviewed and discussed by all of you for a long time.

它也被大家審查和討論了很長時間。

And what you see here is sort of the raw data on how many scripts, what's the TRx volume.

你在這裡看到的是關於有多少腳本、TRx 量是多少的原始數據。

And as you can see here, it's kind of a boring graph because since the beginning of the year, it's completely flat around 10,000.

正如你在這裡看到的，這是一個無聊的圖表，因為自今年年初以來，它完全持平於 10,000 左右。

And that basically means that there hasn't been any real change to our market share and to the mix between our market share and that of competition.

這基本上意味著我們的市場份額以及我們的市場份額與競爭市場份額之間的組合沒有任何真正的變化。

We have roughly 85% of the volume in 40-milligram.

我們大約有 85% 的體積為 40 毫克。

And we maintain a very high level of access.

我們保持非常高的訪問權限。

Of course we've had to take a price hit.

當然，我們不得不承受價格打擊。

That's what you see in the turnover.

這就是你在營業額中看到的。

We have reduced the price by increasing rebates in connection with the generic competition to the benefit, of course, of patients who get the products cheaper now.

我們已經通過增加與仿製藥競爭相關的回扣來降低價格，當然，這些患者現在可以更便宜地獲得產品。

But as you can also see, we are basically hanging on to the volume share quite nicely.

但正如你也可以看到的，我們基本上很好地堅持了交易量份額。

I'm sure there will be questions about what do we expect in terms of increased competition with COPAXONE.

我敢肯定，在與 COPAXONE 的競爭加劇方面，我們預期會有什麼問題。

And of course, we do expect to see tougher competition later in the year.

當然，我們確實希望在今年晚些時候看到更激烈的競爭。

But so far so good.

但到目前為止一切都很好。

We're hanging on to the 85%.

我們堅持 85%。

Another thing that's exciting for us is AUSTEDO.

另一件讓我們興奮的事情是 AUSTEDO。

I talked about it already.

我已經談過了。

And if we take a look here, you can just see that we are accumulating more and more patients quarter-by-quarter.

如果我們看一下這裡，您會發現我們每季度都在積累越來越多的患者。

Our revenues are on target.

我們的收入達到了目標。

We had $30 million of revenue in the first quarter.

我們第一季度的收入為 3000 萬美元。

I mentioned already a quarter ago that the target we have for the full year is around $200 million, and we expect to get very close to that.

我在一個季度前已經提到，我們全年的目標是 2 億美元左右，我們預計會非常接近這個目標。

And the reason why we see this potential short term but also see big long-term potential is, of course, because there's a big unmet need.

我們看到這種短期潛力但也看到巨大的長期潛力的原因當然是因為存在很大的未滿足需求。

You can see how -- our estimates of the unmet medical need.

您可以看到我們對未滿足的醫療需求的估計。

We're talking more than 0.5 million persons in the U.S. who can benefit from this kind of therapy.

我們說的是美國有超過 50 萬人可以從這種治療中受益。

So still there is a big potential market out there, and we're doing our best to grow it, and so far, it's looking good.

所以仍然有一個巨大的潛在市場，我們正在盡最大努力發展它，到目前為止，它看起來不錯。

Now I'll talk about the business development and growth longer term.

現在我將談談長期的業務發展和增長。

Of course, everybody's interested in fremanezumab.

當然，每個人都對 fremanezumab 感興趣。

And we have, as you know, a voucher.

如您所知，我們有一張代金券。

So we are getting a fast review by FDA.

所以我們得到了 FDA 的快速審查。

We've had a very positive collaboration with the FDA, and we have 2 other companies also in that final stages of the review process with FDA.

我們與 FDA 進行了非常積極的合作，我們還有其他 2 家公司也處於與 FDA 審查過程的最後階段。

And we had a surprise, a negative surprise when our manufacturing partner that does the API, Celltrion, got a warning letter.

當我們的製造合作夥伴 Celltrion 收到一封警告信時，我們有一個驚喜，一個負面的驚喜。

And I'm happy to inform you that we are expecting now to see the preapproval inspection take place within the coming months.

我很高興地通知您，我們現在預計將在未來幾個月內進行批准前檢查。

And this will have to go hand in hand with a reinspection of Celltrion, a warning letter reinspection.

這必須與對 Celltrion 的重新檢查（警告信重新檢查）同時進行。

And of course, we have high confidence that both these inspections will be passed, and that means we will be able to get approval and launch before the end of 2018.

當然，我們非常有信心通過這兩項檢查，這意味著我們將能夠在 2018 年底之前獲得批准並啟動。

At the same time, as you know, we have filed fremanezumab in Europe, and that's proceeding just completely standard.

同時，如您所知，我們已經在歐洲提交了 fremanezumab 申請，這完全符合標準。

And we expect to see EMA take action on this.

我們希望看到 EMA 對此採取行動。

We expect an approval in the first half of next year.

我們預計在明年上半年獲得批准。

And just to remind you, in the competitive landscape, of course, there are 3 products that might launch this year, of which we are one.

提醒一下，在競爭格局中，今年可能會推出 3 款產品，我們就是其中之一。

This is a new class that treats chronic migraine very effectively.

這是一個非常有效地治療慢性偏頭痛的新課程。

All the 3 products basically have similar efficacy.

3款產品功效基本相似。

But we do have one key benefit, and that is the fact that our product will most likely be approved for once-quarterly injection, which means that you only need to take your therapy once a quarter.

但我們確實有一個關鍵的好處，那就是我們的產品很可能會被批准用於每季度一次的注射，這意味著您只需要每季度接受一次治療。

We have proven in our clinical trials that, that's exactly the same efficacy as if you do it once a month, which is the case for our competitors.

我們已經在我們的臨床試驗中證明，這與您每月一次的效果完全相同，我們的競爭對手就是這種情況。

So we think everybody who wants a more convenient way of treating their migraine and achieve the same good clinical outcome will be sort of attracted to that we can offer quarterly treatment.

因此，我們認為每個想要一種更方便的偏頭痛治療方法並獲得同樣良好臨床結果的人都會被我們提供的季度治療所吸引。

So that's what I want to say overall on the business.

這就是我想說的關於整個業務的內容。

And now I'll hand over to Michael McClellan, who will comment on the numbers.

現在我將交給 Michael McClellan，他將對這些數字發表評論。

Over to you, Mike.

交給你了，邁克。

Thank you, Kåre.

謝謝你，卡雷。

Good morning, everyone.

大家，早安。

You've received a lot of information today in our press release as well as the 8-K we furnished last week, with a lot of details in our new segment reporting.

您今天在我們的新聞稿以及我們上週提供的 8-K 中收到了很多信息，在我們的新細分報告中有很多細節。

Following the reorganization we announced in November of last year, we have adjusted our segment reporting to align to the new organizational structure of the company.

繼去年 11 月宣布重組後，我們調整了分部報告以適應公司新的組織結構。

We are now organized by 3 regional segments, which have full P&L accountability as well as another noncore activities segment, which includes third-party API business.

我們現在由 3 個區域部門組織，這些部門具有完整的損益責任，以及另一個非核心活動部門，其中包括第三方 API 業務。

To assist you in your analysis, we have provided historical information for select revenues by activity in each of the 3 regions, and for your reference, it is in Slide #26 in the backup sections of this presentation.

為了幫助您進行分析，我們提供了 3 個地區中每個地區按活動劃分的選定收入的歷史信息，供您參考，它位於本演示文稿備用部分的幻燈片 #26 中。

In addition to this information, I think it's important to point out that -- the following, which I hope will help you in adjusting your historical models.

除了這些信息之外，我認為重要的是要指出——以下內容，希望對您調整歷史模型有所幫助。

First of all, our Canadian business, which had annual revenues in 2017 of approximately $590 million, including $476 million in generics, has moved from a Rest of the World into the North American segment.

首先，我們的加拿大業務在 2017 年的年收入約為 5.9 億美元，其中包括 4.76 億美元的仿製藥，已從世界其他地區轉移到北美市場。

Second, our API business, which had approximately $750 million in revenue, is no longer included in the generic figures or in the regions, it is in the separate noncore segment.

其次，我們的 API 業務收入約為 7.5 億美元，不再包含在通用數據或區域中，而是單獨的非核心部分。

For your reference, about 37% of the API sales were generated in the U.S. in 2017, 36% in the growth markets and 27% in Europe.

供您參考，2017 年大約 37% 的 API 銷售額來自美國，36% 來自增長市場，27% 來自歐洲。

API is now under other activities, which also includes our Medis business, which had revenues of $445 million in 2017.

API 現在正在進行其他活動，其中還包括我們的 Medis 業務，該業務在 2017 年的收入為 4.45 億美元。

Third, we moved the payments we received in connection with our agreement to sell the NINLARO royalty stream from Rest of the World to North America in the new segmentation.

第三，在新的細分中，我們將收到的與我們同意將 NINLARO 版稅流從世界其他地區出售到北美的付款一起轉移。

This includes 2 payments of $75 million each in quarter 1 of 2017 and quarter 2 of '17.

這包括 2017 年第一季度和 17 年第二季度的兩筆 7500 萬美元的付款。

And lastly, we had to reclassify Section 8 payments from Canada, which were once, in 2017, netted in G&A expenses but are now in other income.

最後，我們不得不重新分類來自加拿大的第 8 節付款，這些款項曾在 2017 年計入 G&A 費用，但現在計入其他收入。

And you can see those done historically for all of the quarters of 2017.

您可以看到 2017 年所有季度的歷史記錄。

I'd like to take the time now to highlight what we think are some important areas of our results and some more important details on our updated outlook of 2018.

我現在想花點時間來強調一下我們認為的一些重要領域的結果以及我們更新的 2018 年展望的一些更重要的細節。

So turning to Slide 12.

所以轉向幻燈片 12。

As always, we start with a review of our GAAP performance where we posted a quarterly GAAP net income of $1.1 billion and an EPS on a GAAP basis of $1.03 in the first quarter of 2018.

與往常一樣，我們首先回顧了我們的 GAAP 業績，我們在 2018 年第一季度公佈了 11 億美元的季度 GAAP 淨收入和 1.03 美元的 GAAP 每股收益。

As we will detail in the next slide, the higher GAAP results than the non-GAAP come from a combination of some positive items like legal settlements offset by amortization and a few others.

正如我們將在下一張幻燈片中詳述的那樣，高於非 GAAP 的 GAAP 結果來自一些積極的項目，如被攤銷抵消的法律和解和其他一些項目。

So turning to our non-GAAP adjustments.

所以轉向我們的非公認會計原則調整。

You will see that we had several income figures as well as a few impairments.

你會看到我們有幾個收入數字以及一些減值。

Please note that due to a change in the risk-free interest rates, we have adjusted our weighted average cost of capital by about 0.5%, which impacted several of these items leading to some impairments.

請注意，由於無風險利率的變化，我們已將加權平均資本成本調整了約 0.5%，這影響了其中一些項目，導致了一些減值。

Starting with a $706 million of impairments, a portion was related to U.S. intangible assets, mainly due to the changes in fair value of generic products acquired from the Actavis Generics.

從 7.06 億美元的減值開始，一部分與美國無形資產有關，主要是由於從 Actavis Generics 收購的仿製藥的公允價值變化。

In addition, we had a small impairment related to Rimsa, due partially to the change of our weighted average cost of capital as well as a change in allocated net assets to the Rimsa reporting unit.

此外，由於我們的加權平均資本成本的變化以及分配給 Rimsa 報告單位的淨資產的變化，我們與 Rimsa 相關的減值很小。

We also impaired a few assets that were transferred to Procter & Gamble as part of the PGT JV termination.

作為終止 PGT 合資企業的一部分，我們還對一些轉讓給寶潔的資產進行了減值。

And lastly, we recognized some accelerated depreciation in impairments related to site closures as part of the restructuring plan that Kåre mentioned earlier.

最後，作為 Kåre 之前提到的重組計劃的一部分，我們認識到與關閉場地相關的減值加速折舊。

In Q1, we also incurred $247 million in restructuring expenses as part of that program.

在第一季度，作為該計劃的一部分，我們還產生了 2.47 億美元的重組費用。

And I do remind you that we expect a cash effect from restructuring programs to be roughly $800 million for the full year of 2018.

我確實提醒您，我們預計重組計劃帶來的現金效應在 2018 年全年約為 8 億美元。

We also had a series of gains in our GAAP P&L that were adjustments for the -- a couple of special items, including the sale of the non-U.

我們的 GAAP 損益表也有一系列收益，這些收益是對一些特殊項目的調整，包括非 U 的銷售。

S. Women's Health business, the Allergan working capital settlement, a settlement related to our purchase of Rimsa and a reversal of the GSK patent infringement lawsuit for Carvedilol, due to a positive judgment that we received.

S. 女性健康業務、艾爾建 (Allergan) 營運資金和解、與我們購買 Rimsa 相關的和解以及撤銷 GSK 對卡維地洛的專利侵權訴訟，因為我們收到了積極的判決。

Moving on to our GAAP -- non-GAAP results on Slide 14.

繼續我們的 GAAP——幻燈片 14 上的非 GAAP 結果。

Revenues for the first quarter were $5.1 billion, a decrease of 10%, mainly due to generic competition for COPAXONE 40-milligram in the U.S. as well as the market dynamics in the U.S. generic markets and a loss of revenues following the divestment of certain products and discontinuation of certain activities.

第一季度收入為 51 億美元，下降 10%，主要是由於 COPAXONE 40 毫克在美國的仿製藥競爭以及美國仿製藥市場的市場動態以及某些產品撤資後的收入損失和停止某些活動。

The decrease in gross profit margin was mainly the result of the declines in the North American region, mainly due to lower COPAXONE sales and price erosion in the generics market, most of which were price impacts.

毛利率下降主要是由於北美地區的下降，主要是由於 COPAXONE 銷售額下降和仿製藥市場價格侵蝕，其中大部分是價格影響。

Despite the aforementioned decline in our gross profits, the cost savings from our ongoing restructuring program softened the hit and allowed us to keep the loss in EBITDA roughly in line with the loss in revenues of 10%.

儘管我們的毛利潤出現上述下降，但我們正在進行的重組計劃所節省的成本減輕了衝擊，使我們能夠將 EBITDA 的損失與收入損失的 10% 大致保持一致。

Free cash flow, excluding exceptional items, was $1.9 billion in the first quarter of 2018 compared to $0.3 billion in the first quarter of 2017.

2018 年第一季度的自由現金流（不包括特殊項目）為 19 億美元，而 2017 年第一季度為 3 億美元。

This is mainly due to the proceeds that came in from the working capital adjustment with Allergan, the legal settlement with Rimsa, and this compares to a negative impact that you see in Q1 where we had payments for legal settlements, including the FCPA.

這主要是由於與 Allergan 的營運資金調整、與 Rimsa 的法律和解所產生的收益，而這與您在第一季度看到的負面影響相比，我們支付了包括 FCPA 在內的法律和解費用。

On top of that, we also generated some proceeds from the Women’s Health divestiture outside the U.S., bringing the -- us to a total cash generated of $2.5 billion for the quarter.

最重要的是，我們還從美國以外的女性健康業務剝離中獲得了一些收益，使我們本季度的總現金產生了 25 億美元。

Turning to Slide 15.

轉到幻燈片 15。

Again, we see the revenues in the first quarter of 2018 declined 10%.

同樣，我們看到 2018 年第一季度的收入下降了 10%。

In North America, we saw a decline of $566 million, mainly due to generic competition to COPAXONE and the adverse market dynamics in the U.S. generics.

在北美，我們看到了 5.66 億美元的下降，主要是由於仿製藥對 COPAXONE 的競爭以及美國仿製藥的不利市場動態。

In Europe, we had a solid performance, mainly due to new generic launches.

在歐洲，我們的表現穩健，主要是由於新仿製藥的推出。

In growth markets, revenues from better performance in Israel and Japan as well as an AZILECT approval from Takeda raised the sales in that unit.

在成長型市場中，以色列和日本業績的改善以及武田的 AZILECT 批准提高了該部門的銷售額。

Divestments in other mainly includes the Women’s Health divestments of $144 million quarter-on-quarter, the closure of a Hungary distribution activities, the deconsolidation of Venezuela and the nonrecurrence of the payment related to the NINLARO transaction in 2017, which was $75 million.

其他方面的撤資主要包括 1.44 億美元的女性健康資產撤資、匈牙利分銷活動的關閉、委內瑞拉的分拆以及 2017 年與 NINLARO 交易相關的付款不再發生，即 7500 萬美元。

On Slide 16, we look at the non-GAAP operating income in the first quarter 2018, which is $1.4 billion, a decrease of 11% compared to the first quarter 2017.

在幻燈片 16 中，我們查看了 2018 年第一季度的非 GAAP 營業收入，為 14 億美元，與 2017 年第一季度相比下降了 11%。

The cost savings from our ongoing restructuring efforts, which you see benefited all of the regions, especially, Europe, and growth markets, allowed us to partially offset the reductions in revenues in North America.

我們正在進行的重組工作所節省的成本使所有地區都受益，尤其是歐洲和增長市場，這使我們能夠部分抵消北美收入的減少。

And you can also see that the effect of the divestments mentioned on the revenues also had a negative effect of $156 million on the operating profit from 1 quarter last year to Q1 this year.

您還可以看到，從去年第一季度到今年第一季度，上述撤資對收入的影響也對營業利潤產生了 1.56 億美元的負面影響。

On Slide 18, we see EBITDA was $1.6 billion in the first quarter 2018, down 10% compared to the $1.8 billion in the first quarter 2017 but up 4% compared to Q4 2017.

在幻燈片 18 中，我們看到 2018 年第一季度的 EBITDA 為 16 億美元，與 2017 年第一季度的 18 億美元相比下降 10%，但與 2017 年第四季度相比增長 4%。

As we saw on the previous slide, we were able to partially offset the revenue decline in North America and the effects of the divestment with savings coming from the restructuring plan.

正如我們在上一張幻燈片中看到的那樣，我們能夠通過重組計劃帶來的節省部分抵消北美收入下降和撤資的影響。

Going forward, we would naturally expect to see a decline in EBITDA on the coming quarters when we see a full launch of the second generic competitor to COPAXONE 40 milligram in the U.S.

展望未來，當我們看到 COPAXONE 40 毫克的第二個仿製藥競爭對手在美國全面推出時，我們自然會預計未來幾個季度的 EBITDA 會下降。

Turning to Slide 18, you can see global revenues of COPAXONE were $645 million, a decrease of 21% compared to Q4 of 2017.

轉到幻燈片 18，您可以看到 COPAXONE 的全球收入為 6.45 億美元，與 2017 年第四季度相比下降了 21%。

As Kåre mentioned earlier, our COPAXONE market share and volume have held up nicely despite Mylan's introduction of a 40-milligram generic in the United States last October, which has a -- had a greater impact on pricing than on volumes.

正如 Kåre 之前提到的，儘管 Mylan 去年 10 月在美國推出了 40 毫克仿製藥，但我們的 COPAXONE 市場份額和銷量保持良好，這對定價的影響比對銷量的影響更大。

Free cash flow was $1.9 billion in the first quarter of 2017 compared to $0.3 billion in the first quarter of 2017.

2017 年第一季度的自由現金流為 19 億美元，而 2017 年第一季度為 3 億美元。

The increase was mainly due to proceeds from the working capital adjustment with Allergan, the legal settlement with Rimsa compared to negative effects of the FCPA and DOJ payments made in the first quarter of 2017.

增加的主要原因是與 Allergan 的營運資金調整、與 Rimsa 的法律和解，而 2017 年第一季度 FCPA 和 DOJ 付款的負面影響。

Starting this quarter, based on the change in the accounting rules related to the classification of the retained portion of accounts receivables that have been secured, our cash flow from operations does not include these amounts, which totaled to $444 million in Q1 2018 as it comes through the Investing line in the cash flow statement.

從本季度開始，根據與已擔保應收賬款的保留部分分類相關的會計規則的變化，我們的運營現金流不包括這些金額，2018 年第一季度總計為 4.44 億美元通過現金流量表中的投資線。

This has no net effect -- impact on free cash flow.

這沒有淨效應——對自由現金流的影響。

The increase of amounts in the securitization this year from last year is related to the retained percentage that increased following our rerating to BB in late 2017.

本年度證券化金額較去年增加，與 2017 年末我們重評 BB 後留存比例增加有關。

So turning to Slide 20.

所以轉向幻燈片 20。

Since the start of 2018, we've: one, renegotiated the financial covenants with our lending banks; two, issued $4.4 billion of new debt; and three, used the issuance plus the cash generated from free cash flow and divestments to reduce the company's overall net debt by $2.2 billion.

自 2018 年初以來，我們已經： 一，與我們的貸款銀行重新談判了金融契約；二、發行44億美元新債；第三，利用發行加上自由現金流和撤資產生的現金，將公司的整體淨債務減少了 22 億美元。

And we've also extended the debt maturity profile that aligns to the future maturities that we expect to generate in the annual cash flow.

我們還擴展了與我們預計在年度現金流中產生的未來到期日相一致的債務到期日概況。

As you can see in the additional information we've provided that we now have $700 million due for the rest of 2018, mainly Swiss franc loans that we will pay off in Q3 and Q4.

正如您在我們提供的其他信息中看到的那樣，我們現在有 7 億美元在 2018 年剩餘時間到期，主要是我們將在第三季度和第四季度償還的瑞士法郎貸款。

And we have $2 billion in 2019, which we plan to repay with the net cash on hand and the free cash flow that we will be generating in the coming quarters.

我們在 2019 年有 20 億美元，我們計劃用手頭的淨現金和未來幾個季度產生的自由現金流來償還。

I'd also like to highlight the fact that we have no outstanding bank debt subject to financial covenants at the end of Q1 2018.

我還想強調一個事實，即截至 2018 年第一季度末，我們沒有受金融契約約束的未償銀行債務。

In terms of liquidity, I'd just like to point out here that our adjusted net debt-to-EBITDA ratio, which includes the impact of the divestitures being adjusted out, is at 4.68 at the end of Q1, which was a slight decline from 4.82 at the end of the year.

在流動性方面，我想在此指出，我們調整後的淨債務與 EBITDA 比率（包括被調整的資產剝離的影響）在第一季度末為 4.68，略有下降從年底的 4.82 開始。

So for the financial outlook, turning to Slide 23.

因此，對於財務前景，請轉到幻燈片 23。

As Kåre mentioned in his opening remarks, we're increasing our full year guidance due to the strong first quarter performance, along with our confidence in executing the restructuring plan and delivering the rest of the year.

正如 Kåre 在開幕詞中提到的那樣，由於第一季度的強勁表現，以及我們對執行重組計劃和完成今年剩餘時間的信心，我們正在提高全年指導。

This include a free cash flow that will be between $3 billion to $3.2 billion.

這包括將在 30 億至 32 億美元之間的自由現金流。

As we think about the quarterly progression of our performance throughout the end of the year, we believe that the biggest single factor we'll see in the quarterly progression will be the impact of any future full second generic launch of COPAXONE 40 milligram in the United States.

當我們考慮到今年年底業績的季度進展時，我們認為，我們將在季度進展中看到的最大單一因素將是未來在美國全面推出 COPAXONE 40 毫克的第二個仿製藥的影響狀態。

So this concludes my remarks, and I'd like now to turn it back over to the operator who'll start the Q&A session for our call.

我的發言到此結束，我現在想把它交給接線員，接線員將為我們的電話開始問答環節。

Thank you.

謝謝你。

(Operator Instructions) The first question we have today comes from the line of Gregg Gilbert from Deutsche Bank.

（操作員說明）我們今天的第一個問題來自德意志銀行的 Gregg Gilbert。

Kåre, I'm trying to get a sense of urgency or a sense of your sense of urgency to reduce debt.

Kåre，我正試圖獲得一種緊迫感，或者是你減少債務的緊迫感。

Obviously, you've done a good job so far with cash flow.

顯然，到目前為止，您在現金流方面做得很好。

But to the extent your turnaround continues to deliver on plan and the equity price improves, can you talk about your thoughts about using equity at some point to reduce debt to accelerate delevering and get back to playing some offense and being able to do some BD, et cetera?

但是，如果您的周轉繼續按計劃實現並且股價有所改善，您能否談談您對在某個時候使用股權來減少債務以加速去槓桿並重新開始進攻並能夠做一些 BD 的想法，等等？

And my follow-up is for Brendan.

我的後續行動是針對 Brendan。

Curious about the status of your generics Xifaxan program, saw the stay get extended the other day.

對您的仿製藥 Xifaxan 計劃的狀態感到好奇，前幾天看到逗留時間延長了。

I'm trying to understand what that means in terms of your beliefs in approvability of your current application in light of the draft guidance, or the guidance at FDA.

根據指南草案或 FDA 的指南，我試圖了解您對當前申請的可批准性的信念意味著什麼。

I'll answer the first question, then I'll hand it over to Brendan for your second question.

我會回答第一個問題，然後我將把它交給 Brendan 來回答你的第二個問題。

So with regards to using equity, I've said it before and I'm pleased to repeat it again, I have absolutely no plans of issuing new equity.

所以關於使用股權，我之前已經說過了，我很高興再重複一遍，我絕對沒有發行新股權的計劃。

Basically, no matter what the price would be, the plan we have right now is based on, you could say, an organic improvement of the balance sheet by using our cash flows to reduce debt and by a strategy of consolidation and efficiency and profitability improvements over the coming years.

基本上，無論價格如何，我們現在的計劃都是基於，你可以說，通過使用我們的現金流來減少債務以及通過整合和效率和盈利能力提高的戰略來有機地改善資產負債表在未來幾年。

So there are no plans for any kind of M&A activity or any issuance of equity whatsoever.

因此，沒有任何形式的併購活動或任何股權發行的計劃。

We will simply use the operating cash flow we generate to reduce the debt over the coming years.

我們將簡單地使用我們產生的經營現金流來減少未來幾年的債務。

So with that, I hope I addressed that question, and then I'll hand over to Brendan.

因此，我希望我能解決這個問題，然後我將交給 Brendan。

And now Gregg, that was Xifaxan, right?

現在Gregg，那是Xifaxan，對吧？

You got it.

你說對了。

Thank you.

謝謝你。

Yes.

是的。

So just a quick comment on Xifaxan.

所以只是對Xifaxan的快速評論。

Obviously that is driven by the litigation -- the approval.

顯然，這是由訴訟驅動的——批准。

We had a 30-month stay that is over in August of '18.

我們在 18 年 8 月結束了 30 個月的住宿。

We're responding to the FDA's revised guidance around bioequivalence.

我們正在響應 FDA 關於生物等效性的修訂指南。

So we've moved that out of '18 and do not expect a launch in 2018.

因此，我們已將其從 18 年移出，並且預計不會在 2018 年推出。

Okay.

好的。

I hope that addressed your question.

我希望這解決了你的問題。

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。

Just wanted to get a sense, your interaction with the FDA so far on the fremanezumab application.

只是想了解一下，到目前為止，您與 FDA 在 fremanezumab 應用方面的互動。

And what gives you guys, I guess, confidence in approval by year end?

我猜，是什麼讓你們有信心在年底前獲得批准？

And have you guys had any advancement in terms of finding or securing a back-up API support source?

你們在尋找或保護備用 API 支持源方面有什麼進步嗎？

Jason, thanks for that question.

傑森，謝謝你的問題。

I'll handle that.

我會處理的。

So first of all, we've had a very constructive dialogue with FDA, and we continue to have that.

因此，首先，我們與 FDA 進行了非常有建設性的對話，我們將繼續進行對話。

And it's pretty evident from the clinical data that we have and actually that of our committers as well.

從我們擁有的臨床數據以及我們的提交者的臨床數據中可以明顯看出這一點。

There is not much doubt about the efficacy of this class.

這門課的效果沒有太多疑問。

It's very efficacious.

它非常有效。

It's a huge improvement in the health situation for people with chronic migraine.

對於患有慢性偏頭痛的人來說，這是一個巨大的健康狀況改善。

So we don't see any real issues on the efficacy and safety side.

所以我們在有效性和安全性方面沒有看到任何真正的問題。

So the only, you could say, issue we have had outstanding or we still have outstanding is the fact that our API source, Celltrion, have had the warning letter based on the inspection they had last year where they got a 483.

因此，您可以說，我們唯一未解決或仍然存在未解決的問題是，我們的 API 來源 Celltrion 根據他們去年的檢查結果收到了警告信，他們得到了 483。

And we have been in discussions, of course, with FDA on this.

當然，我們一直在與 FDA 討論這個問題。

And based on those discussions, we are expecting to see an inspection of their plant in the coming months.

基於這些討論，我們預計將在未來幾個月內對他們的工廠進行檢查。

And of course, we're expecting that we will be able to have our partner meet the demands from FDA.

當然，我們希望我們的合作夥伴能夠滿足 FDA 的要求。

And based on that, we are expecting to see an approval and launch before the end of this year.

基於此，我們預計將在今年年底之前看到批准和推出。

And we do not have any back-up source that we have filed with the FDA.

而且我們沒有向 FDA 提交的任何備份來源。

So we are basically assuming and expecting that Celltrion will get in good shape in terms of GMP compliance.

因此，我們基本上假設並期望 Celltrion 在 GMP 合規性方面保持良好狀態。

And we have no reasons to believe otherwise.

我們沒有理由不相信。

And Kåre, just to follow up.

還有Kåre，只是為了跟進。

I mean, what, ultimately, makes you confident that the broader issues in the warning letter, beyond just fremanezumab, are resolvable?

我的意思是，最終是什麼讓您確信警告信中的更廣泛問題（不僅僅是 fremanezumab）是可以解決的？

Is that something that you've gained incremental comfort on over the course of the past few months?

在過去的幾個月裡，這是你獲得了越來越多的安慰嗎？

You could say, my assessment is based on mine and then some of my colleagues and external experts' assessment of the outstanding issues mentioned in the 483 and in the activities undertaken by our partner, Celltrion, to remedy all these different deficiencies and make sure that they have a good state of the GMP compliance.

你可以說，我的評估是基於我的，然後是我的一些同事和外部專家對 483 中提到的突出問題以及我們的合作夥伴 Celltrion 開展的活動的評估，以彌補所有這些不同的缺陷並確保他們具有良好的 GMP 合規性。

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

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

Kåre, I just wanted to get a little bit more color around your commentary on the U.S. generics business optimization.

Kåre，我只是想讓你對美國仿製藥業務優化的評論多一些色彩。

Maybe a little bit more detail, kind of where you are in that process?

也許更詳細一點，你在那個過程中的位置？

I'm just sort of wondering, based on your interaction with customers, what's the -- what are some of the pushes and pulls in terms of customers be willing to accept or being told they have to accept the higher price versus risk discontinuation.

我只是想知道，根據您與客戶的互動，在客戶願意接受或被告知他們必須接受更高的價格而不是風險終止方面，有哪些推動和拉動。

And how willing are they to cede on price given what seems to be fairly large retrenchment across many major manufacturers in the U.S. and the potential supply chain risk that creates versus letting you out of some of these contracts without having to be forced to pay a lot of inabilities?

考慮到美國許多主要製造商似乎相當大的裁員以及潛在的供應鏈風險，而不是讓您退出其中一些合同而不必被迫支付很多費用，他們願意在價格上讓步無能？

Second question.

第二個問題。

Just wanted to get a little bit more color around the guidance increase in revenue, hard to get too granular on $200 million or 1% in revenue.

只是想對收入增長的指導性增加一點色彩，很難對 2 億美元或 1% 的收入過於細化。

But just curious if it's fair to say that the bulk of that is COPAXONE and FX.

但只是好奇是否公平地說其中大部分是 COPAXONE 和 FX。

So Elliot, thanks for that.

所以埃利奧特，謝謝你。

I'll give a little bit of color to the U.S. generics, and then I'll let Brendan give some more details, and then Mike will give you some answers on the guidance.

我會給美國仿製藥一點顏色，然後我會讓 Brendan 給出更多細節，然後 Mike 會給你一些關於指導的答案。

But if we start with the overall situation on U.S. generics and pricing, I think it's really important to understand the basics of the dynamics that's been happening.

但如果我們從美國仿製藥和定價的總體情況開始，我認為了解正在發生的動態的基礎知識非常重要。

And the way at least I've analyzed it, is that we had a consolidation on the buyer side, and you had a situation where suppliers were maybe accepting lower prices because they used to have a healthy margin and at least not all market participants, and definitely not Teva, was maybe totally on top of profitability product by product at a very detailed level.

至少我分析過的方式是，我們在買方方面進行了整合，而您的情況是供應商可能會接受較低的價格，因為他們曾經有健康的利潤，至少不是所有的市場參與者，絕對不是梯瓦，可能在非常詳細的層面上完全處於逐個產品的盈利能力之上。

And if you then go into a semi-commoditized market and you take a raise to the bottom on price, then you will be destroying your own profitability.

如果你隨後進入一個半商品化的市場，並且將價格抬高到最低點，那麼你將摧毀你自己的盈利能力。

And the only way to sort of get out of that negative spiral is, of course, to stop it by saying, well, we are not in the business of volume, we're in the business of profitability.

當然，擺脫這種負面螺旋的唯一方法是停止它，說，好吧，我們不是在做數量的生意，我們是在做盈利的生意。

And then changing your course of action without, of course, harming any patients and without harming your customers.

然後改變你的行動方針，當然，不會傷害任何病人，也不會傷害你的客戶。

That's of course very important because these are -- we are the biggest supplier of medicine in the United States.

這當然非常重要，因為我們是美國最大的藥品供應商。

We supply to more patients than anybody else.

我們提供的患者比其他任何人都多。

So we are very keenly aware of that responsibility, and we don't want to cause any disruption.

因此，我們非常清楚這一責任，我們不想造成任何干擾。

But as the market leader, it's also us who are part of setting the tone.

但作為市場領導者，我們也是定調的一部分。

And I just thought it was really important to explain that we are not in the business of just supplying more and more volume for the sake of the volume.

我只是認為解釋一下我們的業務不是為了數量而提供越來越多的數量是非常重要的。

We're in the business of business and that is to have a profitable business.

我們在做生意，那就是有一個有利可圖的生意。

So therefore, we took these initiatives, and there's no risk that we won't be able to supply.

因此，我們採取了這些舉措，並且不存在無法供應的風險。

That's not how we're doing it.

這不是我們的做法。

We're simply doing a classical portfolio optimization exercise.

我們只是在做一個經典的投資組合優化練習。

And I'll turn it over to Brendan, and he can give you a bit more color on how this is progressing with our key customers.

我會把它交給布倫丹，他可以給你更多關於我們的主要客戶進展情況的信息。

Thanks, Kåre.

謝謝，卡雷。

And yes, I'll give you a little bit more color there.

是的，我會給你更多的顏色。

So we've met with all of our major customers and supplied each one of those customers with a list of products that we specifically wanted to address.

因此，我們會見了所有主要客戶，並為每一位客戶提供了我們特別想要解決的產品清單。

And I will say that having worked through all of the issues we have, we're just about through that exercise.

我會說，在解決了我們遇到的所有問題之後，我們即將完成這項工作。

And it's really kind of like an 80-20 rule.

這真的有點像 80-20 規則。

About 80% of the products we will get out of, then they will move to other suppliers; and about 20% of the products, we will see an increase in price on.

大約 80% 的產品我們將退出，然後它們將轉移到其他供應商；而大約20%的產品，我們會看到漲價。

So we've been happy with the response from our customers.

因此，我們對客戶的反應感到滿意。

We've worked with them very cooperatively and responsibly.

我們以非常合作和負責任的方式與他們合作。

And the idea here, as Kåre mentioned, is not to create any kind of supply shortage in the market but to do so in a very easy way for them and for us as well.

正如 Kåre 所提到的，這裡的想法不是在市場上製造任何形式的供應短缺，而是以一種對他們和我們來說都非常簡單的方式來做到這一點。

So we've been able to minimize or even eliminate any failure to supply penalties.

因此，我們能夠最大限度地減少甚至消除任何未能提供供應的處罰。

Thank you, Brendan.

謝謝你，布倫丹。

And then we'll move on to the guidance.

然後我們將繼續進行指導。

And before we do that, I'll just remind you all that when we sent out the guidance a quarter ago for the full year, we had taken into account that this would happen in the U.S. So our $4 billion expectation for U.S. generics sales was inclusive of the loss of turnover as a result of their tail cutting.

在我們這樣做之前，我只想提醒大家，當我們在一個季度前發布全年指導時，我們已經考慮到這將在美國發生。所以我們對美國仿製藥銷售額的 40 億美元預期是包括因剪尾而導致的營業額損失。

And of course, the reason why we do it is that there's no sense in selling products when you had a cash loss on doing it at the margin.

當然，我們這樣做的原因是，當您在邊際上進行現金損失時，銷售產品是沒有意義的。

So there's no real change in the guidance from what we saw a quarter ago and from what we saw now when it comes to the U.S. generics.

因此，與我們在一個季度前看到的以及我們現在看到的關於美國仿製藥的指導相比，沒有真正的變化。

But with that, over to you, Mike, on the $200 million up on top line.

但是有了這個，邁克，頂線的 2 億美元就交給你了。

Yes.

是的。

So I'll tell you a little bit about why we raised the guidance both on the top line and the operating profit.

所以我會告訴你一些關於我們為什麼提高收入和營業利潤的指導。

So the $200 million on the top line is coming across the different regions.

因此，收入中的 2 億美元來自不同地區。

Europe has had a good performance, growth markets as well.

歐洲表現良好，市場也在增長。

We've seen a strong performance in the ANDA business in the U.S. COPAXONE is maintaining very well.

我們看到美國 ANDA 業務表現強勁，COPAXONE 保持良好。

So we're off to a very good start.

所以我們有了一個很好的開始。

It is only 1% on the full year, so it's not a major deviation.

全年僅為 1%，因此並非重大偏差。

FX is a slight advantage there, but we did build our expectations on FX rates that are pretty close to what we've seen in Q1.

外彙在那裡有一點優勢，但我們確實建立了與我們在第一季度看到的非常接近的外匯匯率的預期。

So I don't see that as a major driver.

所以我不認為這是一個主要驅動因素。

We also have included the expectation that we will have a little bit additional cost savings based on what we've seen through the Q1.

我們還期望根據我們在第一季度看到的情況，我們將節省一些額外的成本。

When you add all of that together, you end up with about $200 million both on the top line and on the EBITDA.

當你把所有這些加在一起時，你最終在收入和 EBITDA 上都得到了大約 2 億美元。

And that's the basis of our guidance.

這是我們指導的基礎。

So that's -- it's no one single driver.

所以那是 - 它不是一個單一的驅動程序。

It's just strong performance across the portfolio.

這只是整個投資組合的強勁表現。

The next question today comes from the line of David Risinger from Morgan Stanley.

今天的下一個問題來自摩根士丹利的 David Risinger。

Zhu Shen here for David Risinger.

朱深為大衛·瑞辛格而來。

Could you please discuss the R&D and SG&A cost reduction opportunities looking forward?

您能否討論一下未來的研發和 SG&A 成本降低機會？

Yes.

是的。

That's it for me.

對我來說就是這樣。

Okay.

好的。

Thank you, Zhu Shen.

謝謝朱深。

I'll handle that.

我會處理的。

Yes, you could say, in broad terms, what we've done is we have sort of resized our portfolio and our R&D to what we think is sustainable and needed for a healthy business, and in broad terms, that's sort of ongoing, $1 billion in yearly spend on R&D, roughly 50-50 between generics and specialty.

是的，你可以說，從廣義上講，我們所做的是我們已經調整了我們的投資組合和研發規模，使其達到我們認為可持續發展和健康業務所需的規模，從廣義上講，這是持續的，1 美元每年在研發上的支出為 10 億美元，仿製藥和專業藥物之間大約為 50-50。

Of course, we have some elements, pilot scale, manufacturing upscaling, some clinical testing, whatsoever, where we have facilities that we use both for specialty and R&D.

當然，我們有一些元素，中試規模，製造升級，一些臨床測試，無論如何，我們擁有用於專業和研發的設施。

So we're seeing some synergies there by consolidation of the 2 branches of R&D, which we've done.

因此，我們通過整合兩個研發部門看到了一些協同效應，我們已經這樣做了。

This enables us to constantly produce enough new generic filings to keep our business going long term.

這使我們能夠不斷產生足夠的新仿製藥申請，以保持我們的業務長期發展。

And you could say the $0.5 billion in specialty R&D, in my mind, is enough to keep us going and having a couple of good hits.

在我看來，你可以說 5 億美元的專業研發足以讓我們繼續前進並取得一些不錯的成績。

Not on a yearly basis but over a 10-year period, we will have several good hits, and we will have products like fremanezumab coming to the market, and products like AUSTEDO, like COPAXONE.

不是按年計算，而是在 10 年內，我們將有幾個不錯的產品，我們將有像 fremanezumab 這樣的產品進入市場，像 AUSTEDO 這樣的產品，像 COPAXONE。

These type of products, which will be high, high clinical-benefit, relatively high price in the specialty segment.

這類產品在專科領域將是高、高臨床效益、相對較高的價格。

And we think we can maintain that balance nicely with the current spending.

我們認為我們可以很好地與當前的支出保持平衡。

We don't have any plans of further dramatic reductions below the sort of $1 billion level.

我們沒有任何進一步大幅削減低於 10 億美元水平的計劃。

But we don't see any reason why we would take it or buy over.

但我們看不出有任何理由接受它或買下它。

So sort of for the coming years, that's really the level we are expecting.

因此，對於未來幾年，這確實是我們所期望的水平。

And Mike, you can just give some more clarity on it.

邁克，你可以更清楚地說明它。

Yes.

是的。

Let me give you some color.

讓我給你一些顏色。

Our spend base reduction, we are planning to get to $3 billion by the end of the restructuring plan, we promised $1.5 billion in this year.

我們的支出基數減少，我們計劃在重組計劃結束時達到 30 億美元，我們今年承諾 15 億美元。

If you look at Q1, the spend base versus Q1 of last year is actually down by a net $400 million.

如果您查看第一季度，與去年第一季度相比，支出基數實際上減少了 4 億美元。

That is against a currency headwind of about $190 million.

這與約 1.9 億美元的貨幣逆風相反。

So overall, we were able to reduce the real operating and cost of goods by $420 million.

因此，總的來說，我們能夠將實際運營和商品成本降低 4.2 億美元。

We had a headwind against that of FX of $190 million.

我們遇到了 1.9 億美元的外匯逆風。

But then again, we also benefited from the divestment, which reduces the spend base.

但話又說回來，我們也從撤資中受益，這減少了支出基礎。

It's not part of our $1.5 billion net target that we're talking about.

這不是我們正在談論的 15 億美元淨目標的一部分。

But you'll see, overall, the $400 million is -- minus $400 million in operating, plus $200 million in FX, and then another $150 million coming back out from the divestments.

但你會看到，總體而言，4 億美元是 - 減去 4 億美元的運營，加上 2 億美元的外匯，然後再從撤資中收回 1.5 億美元。

Thank you, Mike.

謝謝你，邁克。

I think that covers the question.

我認為這涵蓋了這個問題。

The next question comes from the line of Irina Koffler from Mizuho.

下一個問題來自瑞穗的 Irina Koffler。

Market in terms of commercialization for AUSTEDO?

AUSTEDO 的商業化市場？

And the second one is, for migraine, we heard at AAN that you would be considering using some of your primary care respiratory reps to promote CGRP.

第二個是，對於偏頭痛，我們在 AAN 聽說您將考慮使用您的一些初級保健呼吸代表來促進 CGRP。

Can you just comment on that briefly?

你能簡單評論一下嗎？

Irina, I'm sorry but for some technical reason, I didn't get fully the first question on AUSTEDO.

伊琳娜，很抱歉，由於某種技術原因，我沒有完全回答關於 AUSTEDO 的第一個問題。

Could you just repeat it please?

請你再重複一遍好嗎？

Sure.

當然。

Are you planning to start promoting AUSTEDO in the psychiatry market more aggressively?

您是否打算開始更積極地在精神病學市場推廣 AUSTEDO？

Okay.

好的。

Thank you very much.

非常感謝。

I will refer both the question on AUSTEDO and the CGRP and respiratory sales force question to Brendan.

我會將有關 AUSTEDO 的問題以及 CGRP 和呼吸銷售人員的問題都提交給 Brendan。

Yes.

是的。

So thank you, Irina, for the questions.

所以，謝謝你，伊琳娜，你的問題。

So in regards to AUSTEDO, yes, we are increasing the amount of sales support around AUSTEDO to the psychiatry group.

所以關於 AUSTEDO，是的，我們正在增加圍繞 AUSTEDO 對精神病學組的銷售支持量。

And we did so just recently, that sales force, that increase in FTEs will be out there in the first part of May.

我們最近才這樣做，那個銷售人員，FTE 的增加將在 5 月上旬出現。

So we're there.

所以我們在那裡。

As far as the question about fremanezumab and how we plan to promote that, we have 2 sales forces that will be promoting fremanezumab.

至於有關 fremanezumab 的問題以及我們計劃如何推廣它，我們有 2 個銷售人員將推廣 fremanezumab。

One is a neuroscience sales force, and we've kind of restructured our respiratory sales force a little bit to allow some promotion there as well.

一個是神經科學銷售隊伍，我們對呼吸系統銷售隊伍進行了一些重組，以便在那裡進行一些晉升。

The next question comes from the line of Liav Abraham from Citi.

下一個問題來自花旗的 Liav Abraham。

First question is on COPAXONE.

第一個問題是關於 COPAXONE。

Just given your experience with one generic 40-milligram on the market and the response of those customers and patients and payers, are there any changes to how you think this market will evolve with 2 generics on the market?

剛剛考慮到您在市場上使用一種 40 毫克仿製藥的經驗以及這些客戶、患者和付款人的反應，您認為市場上的兩種仿製藥將如何發展有什麼變化嗎？

Any change to your assumptions there regarding how the revenues will progress as a second generic enters the market?

隨著第二個仿製藥進入市場，您對收入將如何發展的假設有任何變化嗎？

And then secondly, just on the CRL that Celltrion recently received for biosimilar Rituxan and Herceptin, noticed yesterday that Sandoz received a CRL for its biosimilar Rituxan.

其次，就在 Celltrion 最近收到的生物仿製藥 Rituxan 和 Herceptin 的 CRL 上，昨天注意到 Sandoz 收到了其生物仿製藥 Rituxan 的 CRL。

Was the Celltrion CRL only due to manufacturing?

Celltrion CRL 僅僅是因為製造嗎？

Or were there any other deficiencies noted in that application?

或者該申請中是否有任何其他缺陷？

And any other additional color you could provide there.

以及您可以在那裡提供的任何其他附加顏色。

Thank you for those 2 questions.

謝謝你的這2個問題。

We'll handle the COPAXONE first.

我們將首先處理 COPAXONE。

I'll just give a few general comments, and then Brendan can give you some more specifics.

我將給出一些一般性意見，然後 Brendan 可以給你一些更具體的信息。

From an overall point of view, there's no real change in how we see it.

從整體的角度來看，我們看待它的方式並沒有真正的變化。

You could say the best proxy we have for it is if you look at the 20-milligram where you have 2 players besides us.

你可以說我們擁有的最好的代理是如果你看一下除了我們之外還有 2 名球員的 20 毫克。

That each have a generic in the marketplace.

即每個在市場上都有一個通用的。

And you can get some inspiration by looking at how much volume they've got by now.

您可以通過查看他們現在的音量來獲得一些靈感。

And then you can look to other markets where it's kind of a similar specialty injectable product that we're talking about, similar to COPAXONE.

然後你可以看看其他市場，它是我們正在談論的一種類似的專業注射產品，類似於 COPAXONE。

And my thinking is that we will, of course, see some further pressure on our pricing by the fact that there will be 2 generic 40-milligrams in the marketplace.

我的想法是，由於市場上將有 2 種 40 毫克的仿製藥，我們當然會看到我們的定價面臨更大的壓力。

And probably also marginal pressure on the volume throughout the rest of the year.

並且可能在今年餘下的時間裡對交易量造成邊際壓力。

And that's what we've modeled into our guidance as well.

這也是我們在指導中建模的內容。

But Brendan, do you have any specifics?

但是布倫丹，你有什麼細節嗎？

Any new thoughts on how that will play out?

關於這將如何發揮的任何新想法？

Yes.

是的。

Just a few things to add, Kåre.

只需添加幾件事，Kåre。

So I've been in this market a long time, and I've seen this market evolve.

所以我在這個市場上已經有很長時間了，我見證了這個市場的發展。

And I will tell you that I haven't seen any surprises as the way this market is shaped since 2013, 2014, as we've seen generic competition on 20-milligram as well as 40-milligram.

我會告訴你，自 2013 年和 2014 年以來，這個市場的形成方式我沒有看到任何意外，因為我們已經看到了 20 毫克和 40 毫克的仿製藥競爭。

So as Kåre mentioned, as we see another 40-milligram generic enter the market, I think there will be some downward pressure on price, probably a little on volume as well.

正如 Kåre 所提到的，當我們看到另一個 40 毫克的仿製藥進入市場時，我認為價格將會有一些下行壓力，可能也會有一些壓力。

But today, we maintain about 85% of the overall COPAXONE market, and it is following our expectations and our plans for the year.

但今天，我們維持了整個 COPAXONE 市場約 85% 的份額，並且符合我們的預期和今年的計劃。

With regards to the biosimilars.

關於生物仿製藥。

Then of course, the details, you will have to discuss with Celltrion.

然後，當然，細節，你將不得不與 Celltrion 討論。

But it's so that we assess that the key issue in the CRL for both the products that we have licensed here in the U.S. from Celltrion is really the warning letter, and as such, we are expecting that with a positive reinspection in the coming months, we will be able to see Celltrion eventually lift the CRL and get approval.

但這讓我們評估，我們在美國從 Celltrion 獲得許可的兩種產品的 CRL 中的關鍵問題確實是警告信，因此，我們預計在未來幾個月內會進行積極的重新檢查，我們將能夠看到 Celltrion 最終解除 CRL 並獲得批准。

But our planning is such that we're planning to have these lunches next year, so it's really not something that's affecting the financial outlook for the current year.

但我們的計劃是，我們計劃明年有這些午餐，所以這真的不會影響今年的財務前景。

The next question today comes from the line of Umer Raffat from Evercore.

今天的下一個問題來自 Evercore 的 Umer Raffat。

I actually wanted to focus on 2 of your most important high-flying items.

我實際上想專注於你最重要的兩個高飛項目。

First, Regeneron said in their press release this morning that they're discontinuing the high dose of their NGF program.

首先，Regeneron 在今天早上的新聞稿中表示，他們將停止高劑量的 NGF 計劃。

So I just wanted to get some update from you on what happened?

所以我只是想從你那裡得到一些關於發生了什麼的最新信息？

What was seen at that high dose?

在如此高的劑量下看到了什麼？

Was it RPOA, or was it neurosensory changes?

是RPOA，還是神經感覺變化？

And what does that mean for the overall program now because Teva -- because Pfizer and Lilly really haven't seen much of their RPOA advance from my understanding?

這對現在的整個計劃意味著什麼，因為梯瓦——因為輝瑞和禮來在我的理解中真的沒有看到他們的 RPOA 取得很大進展？

And secondly, on CGRP, my question really is, you mentioned you expect an approval by year-end but not in June.

其次，關於 CGRP，我的問題確實是，您提到您希望在年底前獲得批准，但不會在 6 月獲得批准。

So like mechanistically, how does that work?

所以就像機械地一樣，它是如何工作的？

Because my understanding is, if it's a CRL in June, then you need to wait for an inspection, then refile, which may put a new clock.

因為我的理解是，如果是6月份的CRL，那你需要等一個檢查，然後refile，這可能會放一個新的時鐘。

And I just want to get clarity there.

我只是想弄清楚那裡。

Thank you for those 2 questions.

謝謝你的這2個問題。

First on fasinumab.

首先是fasinumab。

So the details, you would have to discuss, of course, with Regeneron.

因此，您當然必須與 Regeneron 討論細節。

But as it's stated today in their release, what happened was basically that the independent data safety board that's overlooking the trials, they concluded based on an overall risk-benefit analysis that the high-dose arms should be -- or they recommended that the high-dose arms should be discontinued.

但正如今天在他們的新聞稿中所說，發生的事情基本上是獨立的數據安全委員會忽略了這些試驗，他們根據總體風險收益分析得出結論，高劑量藥物應該是 - 或者他們建議高劑量藥物- 劑量臂應停止。

And that's happening.

這正在發生。

And FDA is, of course -- has been updated on everything, and there will now be a dialogue with FDA with regards to the program.

當然，FDA 已經更新了所有內容，現在將與 FDA 就該計劃進行對話。

And so far, the trials are being modified with the high-dose arms being taken out of trials for fasinumab.

到目前為止，這些試驗正在修改，高劑量藥物已退出 fasinumab 的試驗。

With regards to the question on CGRP, then we are in a positive, constructive dialogue with the FDA, and we -- based on that dialogue, we do see a possibility for us having the approval and launch this year.

關於 CGRP 的問題，我們正在與 FDA 進行積極、建設性的對話，我們 - 基於這種對話，我們確實看到了我們今年獲得批准和啟動的可能性。

I can't get into more specific details on that.

我無法對此進行更具體的說明。

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

今天的下一個問題來自 Piper Jaffray 的 David Amsellem。

So just on fremanezumab, just thinking beyond the potential approval.

所以只是在fremanezumab上，只是想超越潛在的批准。

So your competitors, among the monoclonals, are formulating it in auto-injector pens, and your product has relatively high volume compared to the Amgen and Lilly products.

因此，在單克隆抗體中，您的競爭對手正在將其配製在自動注射器筆中，並且與 Amgen 和 Lilly 產品相比，您的產品具有相對較高的容量。

So I just wanted to get a sense of the extent to which you think you can formulate it over time in a pen device.

所以我只是想了解你認為你可以在多大程度上隨著時間的推移在筆設備中製定它。

And do you think that the relatively high injection volume could be -- could put you at a competitive disadvantage?

您是否認為相對較高的注射量可能會使您處於競爭劣勢？

Yes.

是的。

I'll give you the overall comment, then Brendan can give some more details.

我會給你整體評論，然後布倫丹可以提供更多細節。

I don't think we have any disadvantage.

我不認為我們有任何劣勢。

We don't have a significant, high volume of the dosage.

我們沒有大量的劑量。

It's pretty complete standard like nearly other -- any other antibody that's given once a month.

它是非常完整的標準，幾乎與其他任何抗體一樣 - 每月給予一次的任何其他抗體。

And it's comparable to what competition has.

它可以與競爭對手相媲美。

And with regards to the auto-injector then for device development reasons, which are not linked to the product as such, we don't have the approval of the auto-injector that we'll be using yet.

關於自動注射器，出於設備開發原因，與產品本身無關，我們還沒有獲得我們將使用的自動注射器的批准。

But we are interested in moving ahead with that according to plans.

但我們有興趣按計劃推進這項工作。

So we expect to see that in the market.

因此，我們希望在市場上看到這一點。

It's correct that if you get the therapy once a quarter, then of course you get a higher volume once a quarter.

正確的是，如果您每季度接受一次治療，那麼您當然每季度獲得一次更高的治療量。

But it's very likely that their quarterly dosing will be taken place with a nurse or at the doctor's office with some assistance.

但很有可能他們的季度給藥將在護士或醫生辦公室的幫助下進行。

And that in itself might be a preferable for a certain segment of the market.

而這本身對於特定的市場部分可能是更可取的。

At least in my long experience with injectables, fewer injections seems to win over more injections.

至少在我長期使用注射劑的經驗中，更少的注射似乎勝過更多的注射。

That's what I've seen in diabetes over the last 30 years, and it's also what I've seen in psychiatry over the last 5 to 10 years.

這就是我過去 30 年在糖尿病中看到的情況，也是我在過去 5 到 10 年在精神病學中看到的情況。

So I'm very optimistic, there will be a significant part of the markets that will prefer less injections.

所以我非常樂觀，會有很大一部分市場希望減少注入。

But Brendan, do you have any color to add?

但是布倫丹，你有什麼要補充的嗎？

Yes.

是的。

I think there's some confusion regarding fremanezumab and the dosing frequency.

我認為關於 fremanezumab 和給藥頻率存在一些混淆。

So as Kåre said, we will have a monthly as well as a quarterly.

正如 Kåre 所說，我們將有月度和季度。

And the quarterly does require more injections, but it'll give the patient flexibility to have that injection either monthly at home, quarterly at home or quarterly in the doctor's office.

每季度一次確實需要更多的注射，但它可以讓患者靈活地每月在家中、每季度在家中或每季度在醫生辦公室進行注射。

And because it's quarterly in the doctor's office, and there's more than one injection required, I think people are confusing that with our lack of a pen device at launch.

而且因為它每季度在醫生辦公室進行一次，並且需要不止一次注射，所以我認為人們會因為我們在發佈時缺乏筆設備而感到困惑。

So we do have a pen device in development.

所以我們確實有一個筆設備正在開發中。

We hope to launch it after we obviously launch the product itself.

我們希望在我們明顯推出產品本身之後推出它。

And so there's no issue with the pen device.

所以筆設備沒有問題。

It's related to the volume of the product.

這與產品的體積有關。

So we think that we have a very, very competitive offering because we will be the only ones that have the quarterly dosing, and we think that, that will be both a benefit to physicians and patients.

因此，我們認為我們有一個非常非常有競爭力的產品，因為我們將是唯一擁有季度劑量的產品，我們認為這對醫生和患者都有好處。

Any specifics on timing of the launch of the pen device?

關於筆設備推出時間的任何細節？

No.

不。

No specifics.

沒有細節。

It will be following the approval and launch of the product in a prefilled syringe.

它將在預裝注射器中的產品獲得批准和推出之後進行。

But we don't have any specific data on it.

但我們沒有任何具體數據。

The next question today comes from the line of Jami Rubin from Goldman Sachs.

今天的下一個問題來自高盛的 Jami Rubin。

Question for you, Mike, on debt paydown.

邁克，關於償還債務的問題。

You ended this quarter with net debt of $29.3 billion.

您在本季度結束時的淨債務為 293 億美元。

Don't know if I saw it, but do you -- what -- where do you expect that to be by the end of the year?

不知道我是否看到了它，但是你——什麼——你預計到今年年底它會在哪裡？

And just given the results this quarter, and clearly what seems to be faster debt paydown, can you hit 4x leverage by 2019?

剛剛給出了本季度的結果，很明顯，什麼似乎是更快的債務償還，到 2019 年你能達到 4 倍的槓桿率嗎？

And is there an opportunity for further divestitures, which could speed up debt reduction?

是否有機會進行進一步的資產剝離，從而加速減債？

Yes.

是的。

So thank you, Jami.

所以謝謝你，傑米。

So, so far, we have paid down $2.2 billion, which is actually a gross paydown of 2.5, but the currency has gone against us by about $300 million.

所以，到目前為止，我們已經支付了 22 億美元，這實際上是 2.5 的總支付，但貨幣對我們不利約 3 億美元。

We originally said we'd pay down about $3.5 billion this year.

我們最初說我們將在今年支付約 35 億美元。

I think, with the free cash flow guidance range, we will probably try to pay even more now.

我認為，在自由現金流指導範圍內，我們現在可能會嘗試支付更多。

The currency, of course, will be the wild card in that.

當然，貨幣將是其中的通配符。

So I could see us going down another $1.3 billion to $1.5 billion by the end of the year.

所以我可以看到我們到今年年底再減少 13 億美元至 15 億美元。

And we're still on track to meet our goal of 4x by the end of 2020.

我們仍有望在 2020 年底之前實現 4 倍的目標。

But of course, that relies on the fact of us generating enough cash to cover maturities in the next 2.5 years as well as seeing a stronger EBITDA as we go into 2020 and we get past the COPAXONE trough.

但是，當然，這取決於我們在未來 2.5 年產生足夠的現金來支付到期日以及隨著我們進入 2020 年並越過 COPAXONE 低谷而看到更強勁的 EBITDA 的事實。

So we still feel confident that we're on track for it, but there are some moving parts that we will be keeping a close eye on and we will be managing over the course of the next 2 years.

因此，我們仍然對我們正在走上正軌充滿信心，但是我們將密切關註一些活動部分，我們將在未來兩年內進行管理。

In terms of additional asset divestments, we're still looking at a couple of assets that -- we have made public that we are no longer really looking at the ANDA business.

在額外資產剝離方面，我們仍在關註一些資產——我們已經公開表示我們不再真正關注 ANDA 業務。

We're going to keep that and run it.

我們將保留並運行它。

We're still looking at Medis, and there's a few other minor assets.

我們仍在關注 Medis，還有一些其他的小資產。

But we really don't see that as the huge lever to delever.

但我們真的不認為這是去槓桿的巨大槓桿。

It's really about generating organic cash flow and raising the EBITDA over time so that we can get our ratios down to where we want to be.

這實際上是關於產生有機現金流並隨著時間的推移提高 EBITDA，以便我們可以將比率降低到我們想要的水平。

The next question comes from the line of Ami Fadia from Leerink Partners.

下一個問題來自 Leerink Partners 的 Ami Fadia。

I had 2 questions.

我有 2 個問題。

Firstly, just a clarification on fremanezumab.

首先，只是對fremanezumab的澄清。

You indicated that patients will have the option to either self-inject or have it -- have the dose injected at a health care professional's office.

您表示患者可以選擇自行注射或自行注射——在醫療保健專業人員的辦公室注射劑量。

Now how would that impact how the drug is reimbursed between their prescription benefits versus something like a buy-and-bill?

現在，這將如何影響藥物在處方福利與購買和賬單之間的報銷方式？

And secondly, just with respect to Celltrion, could you give us a little bit more color around what gives you confidence that they will be able to address FDA's questions around the warning letter in the coming months, thereby triggering another FDA inspection?

其次，就 Celltrion 而言，您能否為我們提供更多信息，讓您相信他們將能夠在未來幾個月內解決 FDA 關於警告信的問題，從而引發 FDA 的另一次檢查？

Or are you really telling us that irrespective of whether or not they address their issues based on your conversations with the FDA, you still think that they'll come back for a reinspection for fremanezumab?

或者您是否真的告訴我們，無論他們是否根據您與 FDA 的對話解決了他們的問題，您仍然認為他們會回來重新檢查 fremanezumab？

Thank you very much, Ami.

非常感謝，阿米。

I'll try to explain how we see the Celltrion issue first, and then Brendan will talk about the thing about the injections so -- and the reimbursement.

我將首先嘗試解釋我們如何看待 Celltrion 問題，然後 Brendan 將討論有關注射的事情 - 以及報銷。

So the way we see it with Celltrion is, of course, they need to be in a good state of GMP, and we believe that they are, and they have remedied the outstanding issues.

因此，我們對 Celltrion 的看法當然是，它們需要處於良好的 GMP 狀態，我們相信它們確實如此，並且它們已經解決了突出的問題。

But that's of course up to the FDA reinspection to assess that.

但這當然要由 FDA 重新檢查來評估。

And what needs to happen is they need to have a reinspection and there needs to be a PAI, preapproval inspection of fremanezumab API manufacturing.

需要做的是他們需要進行重新檢查，並且需要對 fremanezumab API 製造進行 PAI，即批准前檢查。

Now on the API manufacturing, of course, we've been following that closely for the last years since it's crucial for fremanezumab.

當然，現在在 API 製造方面，我們在過去幾年一直密切關注它，因為它對 fremanezumab 至關重要。

The actual 483 that Celltrion had last year, in June I believe it was, was actually on their Finnish pharmaceutical manufacturing.

Celltrion 去年的實際 483，我相信是在 6 月，實際上是在他們的芬蘭製藥廠。

And of course, they have done everything needed to remedy those deficiencies that they had, and they have, of course, had to inform FDA on an ongoing basis of what they were doing like any other manufacturer would have to do.

當然，他們已經做了一切必要的事情來彌補他們所擁有的這些缺陷，當然，他們必須像任何其他製造商一樣，不斷地通知 FDA 他們正在做的事情。

And they had to report to the FDA that they have now completed their remediation plan as they are ready to take a reinspection.

他們必須向 FDA 報告他們現在已經完成了他們的補救計劃，因為他們準備進行重新檢查。

So they have, of course, done that, and that is why that we say that we expect that there will be a warning letter reinspection and a preapproval inspection in the coming months.

所以他們當然已經這樣做了，這就是為什麼我們說我們希望在未來幾個月內會進行警告信重新檢查和批准前檢查。

And of course, then any approval and launch is then on the assumption that Celltrion has done a good job, and they are in a good state of compliance, and that FDA will find this when they do the reinspection and they do the preapproval inspection.

當然，任何批准和發布都是基於 Celltrion 做得很好，並且處於良好的合規狀態的假設，並且 FDA 會在他們進行重新檢查和批准前檢查時發現這一點。

And based on that, we're saying that we expect approval and launch before the end of this year.

基於此，我們說我們希望在今年年底之前獲得批准和發布。

So I hope that clarifies it.

所以我希望能澄清它。

Now Brendan, could you explain about self-injection and injection at the -- at a clinic and reimbursement and so on in the U.S?

現在布倫丹，你能解釋一下美國的自我注射和在診所注射和報銷等等嗎？

Yes, sure.

是的，當然。

Just let me just jump in on that.

讓我直接說吧。

So we expect that these products being self-injectable products will go through the pharmacy reimbursement.

因此，我們預計這些產品是可自行注射的產品，將通過藥房報銷。

So we're not necessarily saying that this is a medical-reimbursed product, but these are all self-injectables.

所以我們不一定說這是一種醫療報銷產品，但這些都是自我注射的。

But they will also likely go through specialty pharmacy distribution.

但他們也可能會通過專業藥房分銷。

So I think what we're saying is that for patients that want a quarterly option and that may not want to inject it themselves and are likely seeing their neurologist or the physician for migraine once every quarter, that option exists, and there's a way to do that through specialty pharmacy distribution or other channels.

所以我認為我們要說的是，對於想要每季度一次的選擇並且可能不想自己注射並且可能每季度去看一次神經科醫生或偏頭痛醫生的患者，這種選擇是存在的，並且有一種方法可以通過專業藥房分銷或其他渠道做到這一點。

And I really don't want to say much more about our reimbursement strategy other than that.

除此之外，我真的不想多說我們的報銷策略。

The next question today comes from the line of Rohit Vanjani from Guggenheim Partners.

今天的下一個問題來自 Guggenheim Partners 的 Rohit Vanjani。

I just wanted to -- I'm sorry, another question on fremanezumab.

我只是想 -- 對不起，關於fremanezumab 的另一個問題。

I think last time you had said, on the API site where that was being produced had not been inspected.

我想你上次說過，在生產該產品的 API 網站上沒有經過檢查。

So as part of the PAI, will this -- the inspection of the API site be the first time that, that's being inspected?

因此，作為 PAI 的一部分，對 API 站點的檢查會是第一次被檢查嗎？

And then secondly, you mentioned that 80% of products -- 80-20 rule, 80% of products moving and 20% taking a price increase, has that 80% of the products moved yet?

其次，你提到80%的產品——80-20規則，80%的產品搬家，20%的漲價，那80%的產品搬家了嗎？

And if not, is that a 2018 or a 2019 event?

如果不是，那是 2018 年還是 2019 年的事件？

Okay.

好的。

We would take some of the questions.

我們會回答一些問題。

I'll address the fremanezumab API thing, and the Brendan will give you a flavor on the U.S. generics pricing.

我將討論 fremanezumab API 問題，Brendan 將讓您了解美國仿製藥定價。

So the preapproval inspection of fremanezumab, the way you have a preapproval inspection done on an API site is that you have to have your manufacturing up and running.

因此，fremanezumab 的批准前檢查，在 API 網站上進行批准前檢查的方式是，您必須啟動並運行您的製造。

So you got to make sure that you're actually producing fremanezumab when the inspectors come to the site, and they have a good look at everything that's going on.

因此，當檢查員來到現場時，您必須確保您實際上正在生產 fremanezumab，並且他們對正在發生的一切進行了很好的了解。

And since this is a preapproval inspection of a new product, then obviously, that process has not been inspected before.

而且由於這是對新產品的批准前檢查，那麼顯然，該過程以前沒有經過檢查。

But of course, you can also judge from the portfolio that Celltrion has that their API facility as such has been inspected before.

但是，當然，您也可以從 Celltrion 的產品組合中判斷出他們的 API 設施之前已經過檢查。

So that's really the situation on that one.

所以這就是那個人的情況。

Yes.

是的。

So let me address the other question on the 80-20 rule.

那麼讓我來談談關於 80-20 規則的另一個問題。

So the list differs by customer.

因此，列表因客戶而異。

So there is some overlap, of course.

所以當然有一些重疊。

But to just generally answer your question, it's probably more of a 2019 event than it is a 2018 event as we work through the list with each individual customer.

但一般來說，它可能更像是 2019 年的活動，而不是 2018 年的活動，因為我們與每個客戶一起處理列表。

Thank you for that, Brendan.

謝謝你，布倫丹。

I think we will have time now to take one last question.

我想我們現在有時間回答最後一個問題。

The last question today comes from the line of Ronny Gal from Bernstein.

今天的最後一個問題來自 Bernstein 的 Ronny Gal。

I got 2. The first one I got, COPAXONE for Brendan.

我得到了 2 個。我得到的第一個是 Brendan 的 COPAXONE。

Brendan, you've talked about the potential additional pressure coming in from Sandoz.

Brendan，你談到了來自 Sandoz 的潛在額外壓力。

But speaking to payers, it does not seem like anybody is too excited about getting a product from a facility in the [Pearson] when there is like a warning letter every year or so.

但對付款人而言，似乎沒有人對從 [Pearson] 的工廠獲得產品感到太興奮，因為每年左右都會收到一封警告信。

So the question is, until you get additional competitors, do you really expect that Sandoz product to be a pressure?

所以問題是，在你獲得更多競爭對手之前，你真的認為山德士的產品會帶來壓力嗎？

Or are you assuming there'll be other products coming in before the end of the year?

或者您是否假設在今年年底之前會有其他產品上市？

And second, switching over to fremanezumab.

其次，改用fremanezumab。

I know you heard a lot about this today.

我知道你今天聽說了很多。

Brendan, I understand you guys expect the product approved by the end of the year.

Brendan，我知道你們希望產品在年底前獲得批准。

But as we think about the payers' cycle of adoption of anti-CGRPs, how late can you be without beginning to see an impact on your final market share?

但是，當我們考慮到付款人採用反 CGRP 的周期時，您多久才能開始看到對您的最終市場份額的影響？

Do you have to be there for the 2020 contracting cycle in early 2019?

您是否必須在 2019 年初參加 2020 年的合同周期？

Or if something happens and you could be a little bit later, do you still you can get to where you need to be on that market share for this product?

或者，如果發生了什麼事，你可能會晚一點，你還能到達你需要在該產品的市場份額上佔據的位置嗎？

Yes, so Ronny, and thanks for the question.

是的，羅尼，謝謝你的提問。

So let me address the COPAXONE question first.

所以讓我先解決 COPAXONE 的問題。

So beyond Sandoz, we don't expect any other generics competitor come into the market for 40-milligram this year.

因此，除了山德士之外，我們預計今年不會有任何其他仿製藥競爭對手進入 40 毫克市場。

So we're expecting the Sandoz lament their product here in the first half as they've communicated, and we'll see how that shapes.

因此，我們預計 Sandoz 會在上半年對他們的產品感到遺憾，因為他們已經進行了溝通，我們將看看它是如何形成的。

I think we've built that into our plan.

我認為我們已經將其納入我們的計劃中。

If you'd look at the market share that we hold today, about 85%, we will likely see some share on some price, but I think it'll be right according to what we've planned.

如果你看一下我們今天持有的大約 85% 的市場份額，我們可能會在某個價格上看到一些份額，但我認為按照我們的計劃，這將是正確的。

In regards to the question on frem, I think that if we launch in the second half of 2018, we'll be there on time for the 2019 formulary cycle.

關於 frem 的問題，我認為如果我們在 2018 年下半年推出，我們將準時到達 2019 年的處方周期。

We've -- payers are aware of where we are.

我們已經 - 付款人知道我們在哪裡。

We've -- they've been asking questions.

我們——他們一直在問問題。

So I think we'll be right in the mix with everybody else.

因此，我認為我們將與其他所有人混為一談。

My expectation is that payers will wait until all 3 products are on the market before they make their formulary decisions for '19.

我的期望是，付款人將等到所有 3 種產品都上市後，才能做出 19 年的處方決定。

And I would expect that because this is a new class of drug, and this is a -- these are new products that most payers will try to take a look at this and give patients and physicians the flexibility to choose what product's right for them.

我希望這是因為這是一種新的藥物，這是一種新產品，大多數付款人會嘗試看看這個，讓患者和醫生可以靈活地選擇適合他們的產品。

And so hopefully, this is a push towards access for patients.

因此，希望這是對患者訪問的推動。

Thank you very much, everybody, for listening in.

非常感謝大家收聽。

This concludes our Q&A session, and we look very much forward to talking to you again 3 months from now.

我們的問答環節到此結束，我們非常期待 3 個月後再次與您交談。

Goodbye.

再見。

Thank you very much.

非常感謝。

That does conclude the conference for today.

今天的會議到此結束。

Thank you for participating.

感謝您的參與。

You may all disconnect.

你們都可以斷開連接。