Teva Pharmaceutical Industries Ltd (TEVA) 2018 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Teva Pharmaceutical Second Quarter 2018 Financial Results Call.

女士們，先生們，感謝您的支持，歡迎參加梯瓦製藥 2018 年第二季度財務業績電話會議。

(Operator Instructions) I must advise you, the conference is being recorded today, Thursday, the 2nd of August 2018.

（操作員說明）我必須告訴你，今天，2018 年 8 月 2 日星期四，會議正在錄製。

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

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

Please go ahead.

請繼續。

Thank you, Steve, and thank you, everyone, for joining us today to discuss Teva's second 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 年第二季度的財務業績。

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

今天早上早些時候，我們發布了詳細說明本季度業績的新聞稿。

A copy of this release as well as a copy of the slides being presented on the 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 Teva 投資者關係應用程序上找到本新聞稿的副本以及電話會議中展示的幻燈片副本。

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 annual 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年度業績、近期事件和 2018 年展望發表一些評論。

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

我們的首席財務官 Mike McClellan 將更詳細地審查第二季度的財務業績，並討論圍繞我們更新的 2018 年展望的其他假設。

Also joining us on the call today is Brendan O'Grady, Teva's Head of North American Commercial.

Teva 北美商業主管 Brendan O'Grady 也加入了我們的電話會議。

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

有了這個，我會把電話轉給 Kåre。

Kåre, please?

卡雷，好嗎？

Thank you, Kevin.

謝謝你，凱文。

Welcome, everybody, and thanks for your interest in our company.

歡迎大家，感謝您對我們公司的關注。

In the second quarter of this year, we had revenues coming out at $4.7 billion, which is very close to our internal expectations.

今年第二季度，我們的收入為 47 億美元，非常接近我們的內部預期。

We did see a loss per share in our GAAP accounts that was basically due to some significant write-downs on specific assets from the Actavis acquisition and also a write-down on some of the goodwill from the Rimsa acquisition, but these, of course, were noncash events.

我們確實在我們的 GAAP 賬戶中看到了每股虧損，這基本上是由於對 Actavis 收購的特定資產的一些重大減記以及對 Rimsa 收購的一些商譽的減記，但這些當然是，是非現金事件。

In terms of the non-GAAP EPS, we saw that come out at $0.78, and we are very satisfied with that.

就非公認會計原則每股收益而言，我們看到它的價格為 0.78 美元，我們對此非常滿意。

And we also saw a free cash flow of USD 0.6 billion, and we are very satisfied with that too.

我們還看到了 6 億美元的自由現金流，我們對此也非常滿意。

Overall, our restructuring program is well on schedule.

總體而言，我們的重組計劃進展順利。

Everybody is doing a great job with that, so we are slightly ahead of schedule actually.

每個人都在這方面做得很好，所以我們實際上比計劃提前了一點。

And you can see that we had a significant spend base reduction of over USD 1 billion since the start of the year when we compare first half of '18 against first half of '17.

當我們將 18 年上半年與 17 年上半年進行比較時，您可以看到自年初以來，我們的支出基數大幅減少了超過 10 億美元。

So I'm very happy about the efforts and the results coming from all parts of the organization on the cost-reduction program.

因此，我對組織各部門在降低成本計劃方面所做的努力和取得的成果感到非常高興。

In the North American generic marketplace, we saw that revenues in the second quarter of '18 compared to the second quarter of '17 were down, and you would say, the 2 main reasons were the competition we're seeing against our generic Concerta where we have more competitors now, and we are seeing decline in sales of our generic Concerta; and then the price erosion that we really saw last year being very strong and, of course, there's a carryover effect of that.

在北美仿製藥市場，我們看到 18 年第二季度的收入與 17 年第二季度相比有所下降，你會說，兩個主要原因是我們看到的與我們的仿製藥協奏曲的競爭，其中我們現在有更多的競爭對手，我們看到通用協奏曲的銷量下降；然後是我們去年真正看到的非常強烈的價格侵蝕，當然，這是一個結轉效應。

And I do think we see a reduction in price erosion and stabilization of the pricing dynamics in the U.S., but it really has not had any major impact in the second quarter.

我確實認為我們看到美國價格侵蝕的減少和定價動態的穩定，但它在第二季度確實沒有產生任何重大影響。

On our specialty products side, we see very rapid growth of AUSTEDO, growing linearly very nicely.

在我們的特色產品方面，我們看到 AUSTEDO 的增長非常迅速，線性增長非常好。

We're very happy about both the growth in number of patients and also about the growth in sales.

我們對患者數量的增長和銷售額的增長感到非常高興。

And COPAXONE, which I'll get back to, has maintained its share in the U.S. in terms of volume, and that's very positive.

COPAXONE，我會回到，就數量而言，它在美國的份額一直保持不變，這是非常積極的。

We're seeing a very solid performance in Europe.

我們在歐洲看到了非常穩固的表現。

It's fueled by a lot of new product launches, but also by a quite stable situation with regard to both our specialty and generic portfolio in Europe.

許多新產品的推出推動了這一趨勢，但也得益於我們在歐洲的專業和通用產品組合的相當穩定的情況。

All in all, we were able to decrease our net debt by around USD 1 billion, so we're now down to $28.4 billion.

總而言之，我們能夠將淨債務減少約 10 億美元，因此我們現在降至 284 億美元。

As you know, it is our long-term strategy to keep on reducing debt.

如您所知，繼續減少債務是我們的長期戰略。

I'm happy to inform you that based on the better progress on the restructuring program, but also based on a different low expectation for corporate tax that Mike will get into a little later, we are operating our non-GAAP EPS guidance from a band of $2.40 to $2.65 per share to a of $2.55 to $2.80 per share.

我很高興地通知您，基於重組計劃的更好進展，但也基於邁克稍後將進入的對公司稅的不同低預期，我們正在從一個區間操作我們的非公認會計原則每股收益指導每股 2.40 至 2.65 美元至每股 2.55 至 2.80 美元。

And we're also having a minor upgrade of the free cash flow.

我們還對自由現金流進行了小幅升級。

Now we expect it to come out in the range between USD 3.2 billion and USD 3.4 billion.

現在我們預計它將在 32 億美元和 34 億美元之間出現。

Now I said I would get back to COPAXONE, and let me just explain you a little bit about how we see it.

現在我說我會回到 COPAXONE，讓我稍微解釋一下我們是如何看待它的。

You can see here that the revenues in the first and second quarter are pretty similar.

您可以在這裡看到第一季度和第二季度的收入非常相似。

We still see a small decline in the second quarter.

我們仍然看到第二季度有小幅下降。

You can also see that there's a small decline outside of North America and a small decline in North America.

您還可以看到北美以外地區有小幅下降，北美地區也有小幅下降。

We did get the second competitor in the 40-milligram generic space with Glatopa, which was approved, as you know, earlier in the year.

我們確實在 40 毫克仿製藥領域與 Glatopa 獲得了第二個競爭對手，如您所知，它在今年早些時候獲得了批准。

We've seen modest volume share for Glatopa 40 milligram, and we've also seen a relatively stable share for, Mylan increasing slowly, but being sort of around the 15 to 17 percentage points market share.

我們看到 Glatopa 40 毫克的銷量份額適中，我們也看到 Mylan 的份額相對穩定，增長緩慢，但市場份額約為 15 至 17 個百分點。

We have seen a significant reduction from Mylan side recently.

我們最近看到邁蘭方面的大幅減少。

As you saw on the WAC price for the generic 40-milligram COPAXONE.

正如您在通用 40 毫克 COPAXONE 的 WAC 價格上看到的那樣。

And we do expect that, that will, of course, have an effect on the volume, a marginal effect, and also some effect on the pricing.

我們確實預計，這當然會對數量產生影響，產生邊際效應，也會對定價產生一些影響。

So that's why we still predict in our outlook that there will be a continued downward pressure on our quarterly revenues of COPAXONE in the U.S. There will be a marginally negative down drift outside the U.S., so we are still having a very meaningful turnover altogether this year of more than USD 2 billion, but, of course, it will continue to drag this year and next year as we see more generic competition on the product.

因此，這就是為什麼我們仍然在展望中預測 COPAXONE 在美國的季度收入將繼續面臨下行壓力。在美國以外地區將出現小幅負下滑，因此我們今年的營業額仍然非常有意義超過 20 億美元，但當然，隨著我們看到該產品出現更多仿製藥競爭，今年和明年將繼續拖累。

If we switch over to AUSTEDO, then as I told you, we see a very strong linear growth in patients on the product.

如果我們切換到 AUSTEDO，那麼正如我告訴你的那樣，我們看到該產品的患者呈非常強勁的線性增長。

And this is a combination, as you know, of Huntington's disease, chorea and Huntington's and tardive dyskinesia patients.

如您所知，這是亨廷頓病、舞蹈病、亨廷頓病和遲發性運動障礙患者的組合。

We see growth in both patient categories, and we see a nice and steady revenue growth.

我們看到這兩個患者類別的增長，我們看到了良好而穩定的收入增長。

We think this revenue growth will continue, and we maintain the outlook, which is that AUSTEDO, on a yearly basis, in 2018 will do just around USD 200 million.

我們認為這種收入增長將繼續，我們維持前景，即 AUSTEDO 在 2018 年的年收入將達到 2 億美元左右。

On fremanezumab, as you all know, we have a PDUFA date set for mid-September, and our API supplier Celltrion has had a combined inspection, which was a PAI inspection for the API for fremanezumab and also reinspection on the warning letter that Celltrion had.

關於fremanezumab，大家都知道，我們的PDUFA日期定在9月中旬，我們的API供應商Celltrion進行了聯合檢查，這是對fremanezumab API的PAI檢查，也是對Celltrion警告信的重新檢查.

The inspection has been completed in July, and we are expecting still to have approval of the product mid-September.

7 月份已完成檢驗，預計 9 月中旬仍可獲批產品。

And based on getting an approval, we will be ready to launch immediately thereafter.

並且在獲得批准的基礎上，我們將準備在此後立即啟動。

In Europe, we are hoping to see an approval in the first half of 2019.

在歐洲，我們希望在 2019 年上半年獲得批准。

And there, we will be launching in selected markets all based on the different reimbursement procedures that we have in different markets in Europe.

在那裡，我們將根據我們在歐洲不同市場的不同報銷程序在選定的市場推出。

Now this quarter, I would like to share with you just some brief comments on our strategic principles going forward to give you an idea about how we will be pursuing the business in the future.

現在本季度，我想與您分享一些關於我們未來戰略原則的簡短評論，讓您了解我們未來將如何追求業務。

It's no news that we will work as one company.

我們將作為一家公司工作已經不是什麼新聞了。

We have merged specialty generics, OTC, biosimilars, biopharmaceuticals and so on into one organization where we have a classical setup with R&D, manufacturing, global marketing, sales regions, finance and so on.

我們將專業仿製藥、非處方藥、生物仿製藥、生物製藥等合併為一個組織，我們擁有研發、製造、全球營銷、銷售區域、財務等的經典設置。

So we have a very classical setup, which we believe we can make more and more efficient over the coming years, basically working on improvement of our margins.

所以我們有一個非常經典的設置，我們相信我們可以在未來幾年內變得越來越高效，基本上致力於提高我們的利潤率。

We will be pursuing organic growth.

我們將追求有機增長。

The 2 key elements here are that we'll be building our pipeline steadily, but, of course, relatively slowly because we won't do any big acquisitions of any kind, we won't be buying Phase III products, we won't be buying companies.

這裡的兩個關鍵要素是，我們將穩步建立我們的管道，但是，當然，相對緩慢，因為我們不會進行任何形式的大型收購，我們不會購買 III 期產品，我們不會購買公司。

And the reason why we won't be doing this is because we will be spending our cash flow on a constant reduction of our debt, and I'll get back to some long-term financial targets that also describes this.

我們不這樣做的原因是因為我們將把現金流用於不斷減少債務，我將回到一些也描述了這一點的長期財務目標。

Then, of course, we want to maintain our leadership in generics.

然後，當然，我們希望保持我們在仿製藥領域的領先地位。

We want to be both in simple generics, complex generics, injectables, all kind of delivery mechanisms.

我們希望同時使用簡單的泛型、複雜的泛型、可注射劑以及各種交付機制。

We want to be first to file, and we also want to be first to launch, and that's, of course, a key element of our business.

我們希望成為第一個提交申請的人，我們也希望成為第一個發布的人，這當然是我們業務的一個關鍵要素。

In terms of R&D platform, we'll be focusing on biologics, biosimilars, biopharmaceuticals, whatever you want to call it.

在研發平台方面，我們將專注於生物製劑、生物仿製藥、生物製藥，隨便你怎麼稱呼。

We have a shared practical platform, you could say, when it comes to pilot scale manufacturing, upscaling, doing large scale clinical testings, manufacturing of finished products, launch and so on.

我們有一個共享的實踐平台，你可以說，在中試規模製造、升級、進行大規模臨床試驗、成品製造、上市等方面。

And we have certain therapeutic areas, such as neurology, such as oncology, such as respiratory, where we also have the commercial and medical know-how to pursue innovative biologics and biosimilars.

我們擁有某些治療領域，例如神經學、腫瘤學、呼吸系統等，我們還擁有商業和醫學專業知識來追求創新的生物製劑和生物仿製藥。

And then we will have targeted investments.

然後我們將進行有針對性的投資。

What I mean by that is, it's not like we are stopping investments.

我的意思是，我們並沒有停止投資。

For instance, we are building a very nice biologics facility to do large scale manufacturing.

例如，我們正在建造一個非常好的生物製劑設施來進行大規模生產。

We're doing that already.

我們已經在這樣做了。

It's included in our cash flow.

它包含在我們的現金流中。

It's taking place in Germany.

它發生在德國。

We are ensuring that we have all the pilot scale facilities.

我們正在確保我們擁有所有中試規模的設施。

We've done that in the U.S. We have research facilities around the world that continue to do targeted research.

我們在美國已經做到了。我們在世界各地都有研究機構，繼續進行有針對性的研究。

So we will continue to in-license targeted products, but we will not do big scale things, which will be sort of in billion dollars.

所以我們將繼續授權目標產品，但我們不會做大規模的事情，這將是十億美元。

We will preserve the cash flow for debt reduction.

我們將保留現金流以減少債務。

I won't go into all the details about how we are improving our generics business, but just say that active portfolio selection and management is the key thing.

我不會詳細介紹我們如何改進仿製藥業務，而只是說積極的投資組合選擇和管理是關鍵。

We need to make sure that the products where we are first to file, first to launch are products that are profitable and where we can significantly increase our profitability, so you could say we will be valuing profitability over size.

我們需要確保我們首先提交、首先推出的產品是盈利的，並且我們可以顯著提高我們的盈利能力，所以你可以說我們將重視盈利能力而不是規模。

We won't be going for everything.

我們不會全力以赴。

We will be going for what can contribute to our profitability.

我們將尋求可以為我們的盈利能力做出貢獻的東西。

We will keep TAPI and our OTC products integrated commercially, operationally and that, I'm sure, will increase our margins longer term.

我們將保持 TAPI 和我們的 OTC 產品在商業、運營上的整合，我相信這將長期增加我們的利潤。

The same goes for the profitability focus on pricing.

以定價為重點的盈利能力也是如此。

Again, here, both in the pricing dynamics, but also in the efforts of restructuring a whole manufacturing setup, we will be pursuing higher profitability levels, better margins longer term.

同樣，在這裡，無論是在定價動態方面，還是在重組整個製造機構的努力中，我們都將追求更高的盈利水平和更長期的利潤率。

And in the biosimilars space, of course, also there, we will be targeted and focused only pursuing biosimilars that link into our commercial and medical footprint because we believe that you can only really effectively launch biosimilars if you also have a sort of ongoing commercial presence and medical presence in the areas you're going for.

當然，在生物仿製藥領域，我們也將專注於追求與我們的商業和醫療足跡相關的生物仿製藥，因為我們相信，如果您還擁有某種持續的商業存在，您才能真正有效地推出生物仿製藥和您要去的地區的醫療人員。

On the specialty side, of course, we will ensure commercial success of our core assets, such as AUSTEDO, such as AJOVY fremanezumab when we get to launch that.

當然，在專業方面，我們將確保我們的核心資產（例如 AUSTEDO，例如 AJOVY fremanezumab）在我們推出時取得商業成功。

And we will keep on building our own commercial capabilities in those areas and in the different geographies.

我們將繼續在這些領域和不同地區建立我們自己的商業能力。

Fremanezumab will be rolled out worldwide, U.S., Europe, international markets, and we'll be focusing on our internal capabilities in medical, commercial and so on to ensure this.

Fremanezumab 將在全球、美國、歐洲和國際市場推出，我們將專注於我們在醫療、商業等方面的內部能力以確保這一點。

Also, on the R&D side, we will focus on our current capabilities.

此外，在研發方面，我們將專注於我們目前的能力。

We have a wide range of capabilities within biologics and biopharmaceuticals.

我們在生物製劑和生物製藥領域擁有廣泛的能力。

We have a very well established franchise in the respiratory field.

我們在呼吸領域擁有非常完善的特許經營權。

And we have a lot of exciting new projects, which I won't be talking about today, but early-stage things that we think can bring us forward on the longer horizon with a strong pipeline.

我們有很多令人興奮的新項目，我今天不會談論這些，但我們認為早期階段的事情可以通過強大的管道將我們帶到更長的視野中。

But in order to do this in a, you could say, profitable, disciplined way, we have set out some targets that gives you an idea about how we will be looking at our long-term financial performance.

但為了以一種你可以說是有利可圖的、有紀律的方式做到這一點，我們制定了一些目標，讓你了解我們將如何看待我們的長期財務業績。

We've set out 3 targets: operating income margin, cash-to-earnings and net debt-to-EBITDA.

我們設定了 3 個目標：營業收入利潤率、現金收入比和淨債務與 EBITDA 比。

On the operating income margin, we'll be going for 27%.

在營業利潤率方面，我們將達到 27%。

That's slightly above where we are now.

這略高於我們現在的位置。

But you have to remember, we are actually under downward pressure right now from the loss of COPAXONE from the pricing pressures we've seen in generics.

但你必須記住，我們現在實際上正面臨著因仿製藥價格壓力而失去 COPAXONE 的下行壓力。

So we'll probably see that current margin staying below 27% this year, next year, and then we'll help to move it up upwards.

因此，我們可能會看到今年、明年的當前利潤率保持在 27% 以下，然後我們將幫助將其向上移動。

And we have a 3- to 5-year ambition to be at or above 27%.

我們的目標是在 3 到 5 年內達到或超過 27%。

Cash-to-earnings.

現金收入。

We need to make sure that every year, we're turning the results into cash, and we don't spend the cash on things that makes the cash leave the cash earnings because we want to pay down debt.

我們需要確保每年都將結果轉化為現金，並且我們不會因為我們想償還債務而將現金花在使現金離開現金收益的事情上。

So cash-to-earnings, we will aim at being above 80%.

所以現金收入比，我們的目標是80%以上。

And all this, of course, will result in a reduction in debt, and we want our net debt-to-EBITDA to come down below 3x.

當然，所有這一切都會導致債務減少，我們希望我們的淨債務與 EBITDA 之比降至 3 倍以下。

We think these are very realistic targets.

我們認為這些都是非常現實的目標。

We will be focusing on paying down the debt, and we do not have any plans to raise equity.

我們將專注於償還債務，我們沒有任何籌集股權的計劃。

This is all I wanted to start out with.

這就是我想要開始的一切。

I will just sum up briefly.

我簡單總結一下。

Restructuring program is very well on schedule.

重組計劃進展順利。

The debt is being reduced constantly.

債務不斷減少。

Revenue, free cash flow, EPS is on track.

收入、自由現金流、每股收益都在軌道上。

COPAXONE maintaining volume share.

COPAXONE 保持音量份額。

AUSTEDO growing nicely.

AUSTEDO 生長良好。

We are preparing for fremanezumab for AJOVY.

我們正在為 AJOVY 準備 fremanezumab。

And we've just raised the guidance.

我們剛剛提出了指導意見。

So overall, I'm satisfied with the performance in the second quarter.

所以總的來說，我對第二季度的表現感到滿意。

But now for some more financial details, I'll hand over to Mike, our CFO.

但現在關於更多財務細節，我將交給我們的首席財務官邁克。

Thank you, Kåre.

謝謝你，卡雷。

Good morning, good afternoon, everyone.

大家早上好，下午好。

I hope you've had a chance to review our press release we issued this morning.

我希望您有機會查看我們今天早上發布的新聞稿。

I'd like to take some time now to review the numbers of the quarter and provide you with some more detail on our updated outlook for 2018.

我現在想花點時間回顧一下本季度的數字，並為您提供有關我們更新的 2018 年展望的更多詳細信息。

So turning to Slide 14.

所以轉向幻燈片 14。

We start with the review of our GAAP performance.

我們首先審查我們的 GAAP 績效。

We posted a quarterly GAAP net loss of $176 million and a loss per share on a GAAP basis of $0.24 during the second quarter 2018.

在 2018 年第二季度，我們公佈了 1.76 億美元的季度 GAAP 淨虧損和 0.24 美元的 GAAP 每股虧損。

As we'll detail on the next slide, the lower GAAP results are mainly driven by impairment charges of $668 million in the quarter.

正如我們將在下一張幻燈片中詳述的那樣，較低的 GAAP 業績主要是由於本季度 6.68 億美元的減值費用所致。

Turning to our non-GAAP adjustments.

轉向我們的非公認會計原則調整。

The largest were due to impairment of long-lived assets and goodwill, totaling $668 million, comprised mainly of impairment of intangible assets and product rights and in-process R&D assets related to the Actavis Generics acquisition, goodwill impairment related to the Mexican reporting unit, and impairment related to the

最大的一筆是由於長期資產和商譽的減值，總計 6.68 億美元，主要包括與收購 Actavis Generics 相關的無形資產和產品權利以及進行中的研發資產的減值，與墨西哥報告單位相關的商譽減值，和相關的減值

(technical difficulty)

（技術難度）

impairments.

損傷。

We had an amortization of intangible assets totaling $302 million, which is consistent with prior quarters.

我們的無形資產攤銷總額為 3.02 億美元，與前幾個季度一致。

I'd like to point out that $107 million of restructuring expenses were also recorded, mainly pertaining to benefits granted to terminated employees as part of the program announced in December.

我想指出的是，還記錄了 1.07 億美元的重組費用，主要涉及作為 12 月宣布的計劃的一部分授予被解僱員工的福利。

And finally, we had an additional contingent consideration charge of $47 million related to our BENDEKA agreement.

最後，與我們的 BENDEKA 協議有關的額外或有對價費用為 4700 萬美元。

So looking at our non-GAAP performance on Slide 16.

所以看看我們在幻燈片 16 上的非 GAAP 表現。

Revenues for the quarter were $7.4 billion -- or $4.7 billion, a decrease of 18% compared to Q2 of '17.

該季度的收入為 74 億美元，即 47 億美元，與 17 年第二季度相比下降了 18%。

The reduction in sales was mainly related to the continued pressure in North America, with a roughly equal decline in COPAXONE sales and U.S. in generics, which include increased competition to our generic version of Concerta.

銷售額的下降主要與北美的持續壓力有關，COPAXONE 銷售額的下降與美國仿製藥的下降大致相同，其中包括對我們的仿製藥 Concerta 的競爭加劇。

We also saw a minor impact of loss of revenues following the divestment of certain products and discontinued business activities.

我們還看到，在撤資某些產品和停止業務活動後，收入損失的影響很小。

Similarly, the roughly $900 million decrease in gross profit was mainly the result of the sales declines in North American region, which were driven by price impacts, which had a significant negative effect on our gross profit margin.

同樣，毛利潤減少約 9 億美元主要是由於北美地區的銷售額下降，這是受價格影響驅動的，這對我們的毛利率產生了顯著的負面影響。

Despite the aforementioned decline in our gross profit, cost savings from our ongoing restructuring plan and approximately $100 million in other income helped to partially offset the decline in our Q2 operating income.

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節省的成本和大約 1 億美元的其他收入有助於部分抵消我們第二季度營業收入的下降。

I will provide some more information on our spend base reduction later in my presentation.

我將在稍後的演示文稿中提供更多關於減少支出基數的信息。

Our non-GAAP EPS came in at $0.78, giving us a total of $1.71 for the first half of 2018.

我們的非公認會計原則每股收益為 0.78 美元，2018 年上半年的總收益為 1.71 美元。

Free cash flow was at $600 million for the quarter, a similar level to 2017, but was negatively affected by about $100 million of foreign currency fluctuations.

本季度自由現金流為 6 億美元，與 2017 年相似，但受到約 1 億美元外匯波動的負面影響。

And therefore, our total cash generated for debt paydown was about $0.5 billion in Q2 of 2018.

因此，我們在 2018 年第二季度為償還債務產生的總現金約為 5 億美元。

You can see in Q2 of 2017, we had a lower cash generated because we were still paying dividends, and we had some minor asset acquisitions in 2017's Q2.

您可以在 2017 年第二季度看到，我們產生的現金較少，因為我們仍在支付股息，並且我們在 2017 年第二季度進行了一些小型資產收購。

Briefly on foreign currency movements, we did see a little bit of weakening of the dollar versus other currencies when you compare Q2 of this year versus Q2 of last year, and that gave us a slight increase of $92 million in the revenue line and roughly $20 million on the profit line.

簡要介紹外匯走勢，當您將今年第二季度與去年第二季度進行比較時，我們確實看到美元兌其他貨幣略有走弱，這使我們的收入略有增加 9200 萬美元，大約 20 美元萬元的利潤線。

We do expect in the second half the currencies, as the dollar is starting to strengthen, to potentially be a little more of a headwind versus the second half of 2017.

我們確實預計，隨著美元開始走強，下半年貨幣與 2017 年下半年相比可能會更加不利。

In terms of quarterly revenue on Slide 18.

就幻燈片 18 的季度收入而言。

To give you a better view of the positive and negative changes, we have an overall decline of 18% compared to Q2 2017.

為了讓您更好地了解積極和消極的變化，與 2017 年第二季度相比，我們總體下降了 18%。

But looking at the segments and excluding the impact of divestments and other special items, the biggest reduction was in North America, mainly due to the generic competition to COPAXONE as well as a decline in the U.S. generic businesses that I previously mentioned.

但從細分市場來看，剔除撤資和其他特殊項目的影響，減少幅度最大的是北美，主要是由於仿製藥對 COPAXONE 的競爭以及我之前提到的美國仿製藥業務的下滑。

In addition, we saw a very low quarter for QVAR due to the timing of wholesale orders following our Q1 launch of the new RediHaler device, and this was offset by the uptick in AUSTEDO and a continuation of the strong performance in our ANDA business.

此外，由於我們在第一季度推出新的 RediHaler 設備後批發訂單的時間安排，我們看到 QVAR 的季度非常低，這被 AUSTEDO 的增長和我們 ANDA 業務持續強勁表現所抵消。

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

在歐洲，我們的表現非常穩健，主要是由於新仿製藥的推出。

In International Markets, our revenues were relatively flat net of the currency exchanges.

在國際市場，我們的收入在扣除貨幣兌換後相對持平。

And the divestments and other is mainly the Women's Health divestments from last year, the closure of the Hungary distribution activities and nonrepeat of the payment of the NINLARO royalties that we had in Q2 of 2017.

撤資和其他主要是去年的女性健康撤資，匈牙利分銷活動的關閉以及我們在 2017 年第二季度支付的 NINLARO 特許權使用費不再重複。

Turning to COPAXONE.

轉向 COPAXONE。

The quarterly revenues were $626 million, which was consistent with the first quarter.

季度收入為 6.26 億美元，與第一季度一致。

As we go forward to the second half, we expect sales to decline compared to Q2 levels due to the additional pricing pressure and expected uptake of the second generic entrant that Kåre mentioned earlier.

隨著我們進入下半年，由於額外的定價壓力和 Kåre 之前提到的第二個仿製藥進入者的預期吸收，我們預計銷售額將比第二季度下降。

We expect for the full year global COPAXONE sales to be roughly $2.1 billion, including $1.5 billion in the United States.

我們預計全年全球 COPAXONE 銷售額約為 21 億美元，其中包括美國的 15 億美元。

On Slide 20, non-GAAP operating income in the second quarter of 2018 was $1.2 billion, a decrease of 22% compared to the second quarter of 2017.

在幻燈片 20 上，2018 年第二季度非美國通用會計準則營業收入為 12 億美元，與 2017 年第二季度相比下降 22%。

Our European business grew significantly due to the increase in revenues as well as the cost savings from our restructuring program.

由於收入的增加以及重組計劃的成本節約，我們的歐洲業務顯著增長。

Our International Markets also benefit mostly from the restructuring savings as sales were relatively flat.

由於銷售額相對持平，我們的國際市場也主要受益於重組節省的資金。

And profit in North America was significantly impacted by the revenue decline mentioned earlier, partially offset by the savings in our cost base and some other income for the quarter.

北美的利潤受到前面提到的收入下降的顯著影響，部分被我們成本基礎的節省和本季度的一些其他收入所抵消。

On Slide 21, we're providing our year-to-date achievements in reducing our overall spend base, which totaled a net of $1.1 billion in the first 6 months of 2018.

在幻燈片 21 上，我們提供了年初至今在減少總體支出基礎方面取得的成就，2018 年前 6 個月的淨支出總額為 11 億美元。

The reductions in the first half were approximately $300 million in sales and marketing, $350 million in R&D, $200 million in the cost of goods line and $100 million in G&A.

上半年減少的銷售和營銷費用約為 3 億美元，研發費用為 3.5 億美元，產品線成本為 2 億美元，G&A 費用為 1 億美元。

We also experienced some foreign exchange headwinds, totaling $267 million, which offset most of the reduction in the spend base that we had from divested businesses.

我們還經歷了一些外匯逆風，總計 2.67 億美元，這抵消了我們從剝離業務中減少的大部分支出基礎。

In addition, since Teva's announcement of its restructuring plan, the company has reduced its global headcount by approximately 800 -- or 8,300 employees.

此外，自 Teva 宣布重組計劃以來，該公司已將其全球員工人數減少了約 800 人，即 8,300 人。

As Kåre said before, we're feeling very good regarding the execution of our restructuring plan to date, and we're confident in our ability to reach the reduction of $1.5 billion in 28 (sic) [2018] compared to 2017 year-end's spend base of $16.3 billion.

正如 Kåre 之前所說，迄今為止，我們對重組計劃的執行感到非常滿意，我們有信心在 28 (sic) [2018] 年與 2017 年底相比減少 15 億美元。支出基數為 163 億美元。

Furthermore, we're on track to deliver the full reduction target of $3 billion by the end of 2019 versus the 2017 base.

此外，我們有望在 2019 年底與 2017 年的基數相比，實現 30 億美元的全部削減目標。

Free cash flow for this quarter was $559 million, which is slightly lower than in Q2 of 2017.

本季度的自由現金流為 5.59 億美元，略低於 2017 年第二季度。

When comparing the second quarter free cash flow to the first quarter, please recall that the first quarter figure included significant onetime proceeds from the working capital adjustment with Allergan and the legal settlement with Rimsa as well as lower net CapEx due to the sale of some minor assets.

在將第二季度的自由現金流與第一季度進行比較時，請回想一下，第一季度的數據包括與 Allergan 的營運資金調整和與 Rimsa 的法律和解以及由於出售一些小型企業而導致的較低淨資本支出的一次性重大收益資產。

Turning to Slide 23.

轉到幻燈片 23。

We continue to focus on reducing Teva's debt.

我們繼續專注於減少梯瓦的債務。

At the end of second quarter, Teva's net debt fell by approximately $1 billion compared to March 31 to land at $28.4 billion.

在第二季度末，梯瓦的淨債務與 3 月 31 日相比減少了約 10 億美元，達到 284 億美元。

This was driven by cash generation as well as favorable foreign exchange fluctuations.

這是由現金產生以及有利的外匯波動推動的。

In addition, we've paid down CHF 300 million bond that was due at the end of July, and we plan to use the current cash balance and future cash flow to continue paying down maturities coming due in the near term.

此外，我們已經償還了 7 月底到期的 3 億瑞士法郎債券，我們計劃利用當前現金餘額和未來現金流繼續償還近期到期的債券。

Our focus continues to be on executing our restructuring plan to free up cash that we can use to rapidly reduce our net debt.

我們的重點仍然是執行我們的重組計劃，以釋放可用於快速減少淨債務的現金。

Since the start of this year, we've been able to reduce our net debt by over $3 billion.

自今年年初以來，我們已經能夠將淨債務減少超過 30 億美元。

And if we compare today's level to the third quarter of '16 directly following the Actavis/Allergan acquisition, we've reduced our net debt from the peak of $35 billion by nearly $7 billion as of the end of June this year.

如果我們將今天的水平與 16 年第三季度阿特維斯/艾爾建收購後的水平進行比較，截至今年 6 月底，我們的淨債務已從 350 億美元的峰值減少了近 70 億美元。

So as Kåre mentioned in his opening remarks, we are increasing our full year guidance for the second time this year, including increase in our EPS to a range of $2.55 to $2.80.

因此，正如 Kåre 在開場白中提到的那樣，我們今年第二次上調全年指引，包括將每股收益提高到 2.55 美元至 2.80 美元之間。

Our updated guidance reflects higher other income in the second quarter of 2018, accelerated cost reductions from our restructuring plan and a lower tax rate driven by our overall business mix.

我們更新後的指引反映了 2018 年第二季度的其他收入增加、重組計劃加快了成本削減以及我們的整體業務組合推動了較低的稅率。

As we think about the second half of the year, we believe that the single greatest variable on performance will continue to be the impact of generic competition to COPAXONE as well as timing of the generic launches in the U.S.

考慮到下半年，我們認為影響性能的最大變量將繼續是仿製藥競爭對 COPAXONE 的影響以及仿製藥在美國上市的時間。

This concludes my remarks and I'd like to now turn the call back over to the operator to start the question-and-answer session of our call.

我的發言到此結束，我現在想將電話轉回給接線員，以開始我們電話的問答環節。

Thank you.

謝謝你。

(Operator Instructions) The first question we have today comes from the line of Liav Abraham from Citi.

（操作員說明）我們今天的第一個問題來自花旗的 Liav Abraham。

Just a question on COPAXONE.

只是一個關於 COPAXONE 的問題。

Based on your revised COPAXONE guidance, my understanding is that you're expecting to do about $550 million in the second half in the U.S. versus $940 million in the first half.

根據您修改後的 COPAXONE 指導，我的理解是，您預計下半年在美國的銷售額約為 5.5 億美元，而上半年則為 9.4 億美元。

So that's a decline -- about 40% reduction second half versus first half based on my calculations.

所以這是一個下降——根據我的計算，下半年與上半年相比減少了大約 40%。

Maybe, Mike and Kåre, you can talk -- can you talk a little bit more in detail about what exactly you're expecting for volume and price in the second half versus the first half?

也許，邁克和卡雷，你們可以談談——你們能否更詳細地談談你們對下半年與上半年的銷量和價格的確切預期？

And your maybe more specific assumptions on the impact of Mylan's recent pricing action on your net price for the second half and then going into 2019, if possible?

如果可能的話，您對邁蘭最近的定價行動對您下半年和 2019 年淨價的影響是否有更具體的假設？

Thank you, Liav.

謝謝你，利亞夫。

This is Kåre Schultz.

這是卡雷舒爾茨。

I will give you a little bit of an overall answer and then we have Brendan here, who is the Head of U.S. and he can further comment on it.

我會給你一個整體的答案，然後我們有布倫丹在這裡，他是美國的負責人，他可以進一步評論。

So first of all, we have to acknowledge the fact that it's hard to predict precisely generic erosion curves on original products, how they sort of lose out in volumes to generics these days.

所以首先，我們必須承認這樣一個事實，即很難準確預測原始產品的仿製藥侵蝕曲線，這些天它們如何在數量上輸給仿製藥。

There's been a lot of changing dynamics in the marketplace.

市場上有很多變化的動態。

And for that reason, it's difficult to predict.

因此，很難預測。

And COPAXONE is difficult to predict, and I've been in situations in previous companies with other products that have also been difficult to predict.

而 COPAXONE 是很難預測的，我在以前的公司中也遇到過其他產品也很難預測的情況。

So when we give our guidance, of course, we need to take everything into consideration.

因此，當我們給予指導時，當然，我們需要考慮到一切。

And as you can see, we've been holding on to roughly 85% of the volume in the first and the second quarter of this year.

正如你所看到的，我們在今年第一季度和第二季度一直保持著大約 85% 的銷量。

But we do think that's a very high level, and we are seeing probably right now that we have slightly less maybe 83% of the volume.

但我們確實認為這是一個非常高的水平，而且我們現在可能看到我們的交易量略低於 83%。

So we are expecting that the fact that we have 2 generic competitors will lead to some reduction of the volume.

因此，我們預計我們有 2 個通用競爭對手的事實將導致數量有所減少。

And then, of course, in terms of price, that's a complicated game where we have a lot of different contracts that we're negotiating and then that could also be some impact there.

然後，當然，在價格方面，這是一個複雜的遊戲，我們正在談判許多不同的合同，然後這也可能產生一些影響。

But you have to, I would say, have the facts from us that we don't know how this is going to play out exactly.

但我想說，你必須從我們那裡得到事實，我們不知道這將如何準確地發揮作用。

Of course, we can't know.

當然，我們無法知道。

So there's always an uncertainty on this, and that's also why we have the range on our earnings per share because it could go -- data could go worse.

因此，這始終存在不確定性，這也是我們確定每股收益範圍的原因，因為它可能會發生變化——數據可能會變得更糟。

But we think we're taking a prudent approach and coming out with a guidance that is very, very realistic.

但我們認為我們正在採取謹慎的態度，並提出非常非常現實的指導。

But maybe, Brendan, you have some further comments?

但也許，布倫丹，你還有其他意見嗎？

Yes, thanks, Kåre.

是的，謝謝，Kåre。

So I think if you look at the impact on the market, I think that the market has somewhat overreacted to the WAC price drop by Mylan.

所以我認為，如果你看看對市場的影響，我認為市場對邁蘭的 WAC 價格下跌反應有些過度。

I think that the -- probably even net price, their selling hasn't changed all that much.

我認為 - 甚至可能是淨價格，他們的銷售並沒有太大變化。

They've just lowered the gross to net.

他們剛剛將總收入降至淨額。

And that's not something that was completely unexpected.

這並不是完全出乎意料的事情。

If you think about when Momenta or Sandoz would come in stronger with our product originally, we had thought it would be April, then we would -- thought it would be July.

如果您考慮一下 Momenta 或 Sandoz 最初使用我們的產品何時會變得更強大，我們曾認為會是 4 月，然後我們會 - 認為會是 7 月。

And they're still trying to build towards that.

他們仍在努力實現這一目標。

So when that event happen, we predict there would be more price competition.

因此，當該事件發生時，我們預測將會有更多的價格競爭。

And as Kåre said, we had planned for some continued mild erosion in both volume as well as price.

正如 Kåre 所說，我們已經計劃在數量和價格上繼續進行一些輕微的侵蝕。

So I think the $600 million for the second half of the year is certainly doable, and I think the $1.5 billion is -- we're on target for that.

所以我認為下半年的 6 億美元肯定是可行的，而且我認為 15 億美元是——我們正在實現這一目標。

Maybe just a quick follow-up.

也許只是一個快速的跟進。

You kept your revenue guidance flat, but you've increased your COPAXONE guidance for the full year.

您的收入指導保持不變，但您增加了全年的 COPAXONE 指導。

So what is -- where are you expecting things to get a little worse than your expectations at your Q1 earnings?

那麼是什麼 - 你預計第一季度收益會比你的預期更糟糕嗎？

Yes.

是的。

So, Liav, I'll take that one.

所以，利亞夫，我要那個。

We're seeing a couple of things as we go into the second half.

當我們進入下半場時，我們看到了一些事情。

COPAXONE has come up for the full year, and we did raise the revenue a little bit in the first quarter.

COPAXONE 已經全年推出，我們確實在第一季度增加了一點收入。

We're having -- and as we go into the second half, we do actually see some currency headwinds.

我們正在經歷 - 當我們進入下半年時，我們確實看到了一些貨幣逆風。

So we are going to see a decline in the the dollar-based sales for the nondollar regions, Europe and International Markets.

因此，我們將看到非美元地區、歐洲和國際市場以美元為基礎的銷售額下降。

We're also seeing a little bit of headwinds in the U.S. generics and some assets like QVAR, which is a little bit lower than we originally expected.

我們還看到美國仿製藥和 QVAR 等一些資產的一些不利因素，這比我們最初預期的要低一些。

So overall, we see revenues still coming in relatively in line, but we're going to have a little bit more profitability, and that's why we've raised the EPS and the cash flow.

所以總的來說，我們看到收入仍然相對穩定，但我們將獲得更多的盈利能力，這就是我們提高每股收益和現金流的原因。

The next question today comes from the line of David Maris from Wells Fargo.

今天的下一個問題來自富國銀行的 David Maris。

A couple of questions.

幾個問題。

First, Kåre, you mentioned that you're seeing an improved U.S. generic pricing dynamic, but you're not experiencing it yet.

首先，Kåre，您提到您看到美國通用定價動態有所改善，但您還沒有體驗到它。

So can you kind of explain to us that nuance?

那麼你能向我們解釋一下這種細微差別嗎？

And I would suspect that Teva is representative of the market.

我懷疑梯瓦是市場的代表。

So where are you seeing it?

那你在哪裡看到的？

And should that continue through the year?

這種情況應該持續到今年嗎？

Or is it something that you think might just be temporary?

還是您認為可能只是暫時的？

And then second, can you explain a bit how the long-term targets you've provided today differ from the ones that you used at your previous firm and why not a return on invested capital target?

其次，您能否解釋一下您今天提供的長期目標與您在以前的公司使用的長期目標有何不同，為什麼不提供投資資本回報率目標？

So thanks for those 2 questions, David.

所以感謝這兩個問題，大衛。

So first on the generic pricing.

所以首先是通用定價。

The way it works is, of course, that on a day-to-day basis, there's all kind of requests for proposal on this, that and the other product.

當然，它的工作方式是每天都有關於這個、那個和其他產品的各種提案請求。

There's all kind of pricing discussions with customers on thousands and thousands of products.

與客戶就成千上萬種產品進行各種定價討論。

And our assessment of that is not precisely identical with the market because we don't have full insight into the market.

我們對此的評估與市場並不完全相同，因為我們對市場沒有全面的了解。

But based on what we're seeing in the second quarter, we believe that there's an improved pricing dynamic on U.S. generics.

但根據我們在第二季度看到的情況，我們認為美國仿製藥的定價動態有所改善。

That being said, of course, the actual sales you have are also very much affected by the launches you have and by competition on volume.

話雖如此，您的實際銷售額當然也受到您的發布和數量競爭的很大影響。

And as I said in the beginning, we have seen a strong volume competition pickup on Concerta because there's been other generics to Concerta being launched and, therefore, we're losing sales on Concerta.

正如我在開始時所說，我們已經看到 Concerta 的銷量競爭強勁，因為 Concerta 的其他仿製藥正在推出，因此，我們正在失去 Concerta 的銷售。

So that is really nothing to do with the pricing, that's more the effect of more approvals coming in.

所以這實際上與定價無關，更多的是更多批准的影響。

And we've had relatively few new launches in Q2 than we had in Q1, and that also affects the sales, of course.

與第一季度相比，我們在第二季度推出的新產品相對較少，這當然也會影響銷售。

So I cannot give you any firm conclusion on whether this improved pricing dynamic will continue or whether it's just a reaction to the very, very bad pricing dynamics in the third and fourth quarter of last year, and it's going to come back.

因此，我無法就這種改善的定價動態是否會繼續，或者它是否只是對去年第三季度和第四季度非常非常糟糕的定價動態的反應給出任何明確的結論，並且它會捲土重來。

I don't think it will come back.

我不認為它會回來。

I think we will see a more, I would call, mature and sensible market where we have a more stable situation now with 3 big buyers and a number of manufacturers, of course.

我認為我們會看到一個更成熟、更明智的市場，當然，我們現在有一個更穩定的情況，有 3 個大買家和一些製造商。

So I think we have reached a new level of generic pricing, which is actually pretty close to the European level now.

所以我認為我們已經達到了一個新的通用定價水平，這實際上非常接近現在的歐洲水平。

So at least when you discuss drug pricing, you can't say that U.S. generics are more expensive than elsewhere in the world on average.

所以至少當你討論藥品定價時，你不能說美國的仿製藥平均比世界其他地方貴。

And that is also an indication for us reaching a level of stabilization.

這也表明我們達到了穩定水平。

Then if I can just jump to the other question, which is the long-term financial targets, then I would say, there's a big similarity between these targets and targets that I said when I was in my previous job as CEO of Lundbeck.

然後，如果我可以直接跳到另一個問題，即長期財務目標，那麼我會說，這些目標與我在擔任靈北首席執行官時所說的目標之間有很大的相似之處。

And it's basically because it matters that you generate cash whether you use it to pay to your debt investors, which is what we have here because we have so much debt or whether you use it to pay to your shareholders because you don't have debt and you return money to the shareholders.

這基本上是因為無論你用它來支付給你的債務投資者，你產生現金都很重要，這就是我們在這裡擁有的，因為我們有很多債務，或者你是否用它來支付給你的股東，因為你沒有債務你把錢還給股東。

It doesn't really change your target for the cash you want to have, the cash of earnings that you need.

它並沒有真正改變你想要擁有的現金的目標，你需要的收入現金。

And in the case here in Teva, we simply have too much debt, so we need to have a target of bringing down the debt.

在梯瓦的案例中，我們的債務太多了，所以我們需要有一個降低債務的目標。

And you can only do that if you have a good cash-to-earnings ratio, and you can only generate cash and earnings if you have a good margin, and that's why we're setting the margin target of 27%.

只有擁有良好的現金收益比，您才能做到這一點，並且只有擁有良好的利潤率才能產生現金和收益，這就是我們將利潤率目標設定為 27% 的原因。

And I think that's in line with what a mixed company like ours with the product portfolio we have can reasonably be expected to achieve in a 3- to 5-year time scale.

而且我認為這與像我們這樣的混合公司與我們可以合理地預期在 3 到 5 年的時間範圍內實現的產品組合是一致的。

And of course, this is not the end of the road.

當然，這不是路的盡頭。

I mean, we would like to do even better, but as you also know, it's my policy that you set targets and then you don't discuss new targets before you reach them.

我的意思是，我們希望做得更好，但您也知道，我的政策是您設定目標，然後在達到新目標之前不要討論新目標。

So we've set these 3 targets.

所以我們設定了這三個目標。

We will reach these 3 targets within the next 3 to 5 years.

我們將在未來 3 到 5 年內實現這 3 個目標。

Once we reach them, we'll set new targets for the future periods.

一旦我們達到這些目標，我們將為未來時期設定新的目標。

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。

Kåre, if sales stay at $17 billion to $18 billion, your longer-term guidance for operating margins basically imply the EBITDA at $5.2 billion to $5.5 billion; $5.2 billion is what you've sort of guided to this year, which is basically not much growth.

Kåre，如果銷售額保持在 170 億至 180 億美元，您對營業利潤率的長期指導基本上意味著 EBITDA 為 52 億至 55 億美元； 52 億美元是你今年的指導，這基本上沒有太大的增長。

You had -- you and Kåre had talked about returning the business to growth post the trough.

你曾經 - 你和 Kåre 曾討論過在低谷後讓業務恢復增長。

So I'm wondering if you could talk about that.

所以我想知道你是否可以談談這個。

Secondly, what are your assumptions for net debt by year-end and your level of debt paydown this year, next year?

其次，您對年底的淨債務以及今年、明年的債務償還水平有何假設？

You had talked about potentially selling Medis.

您曾談到可能出售 Medis。

I don't know where that is in the discussions.

我不知道這是在討論中的什麼地方。

And then lastly, Brendan, if you can just give us a little bit of color on ANDA approvals.

最後，Brendan，如果你能給我們一點關於 ANDA 批准的信息。

I know there hasn't been much, but what are you expecting?

我知道沒有太多，但你在期待什麼？

What's going on -- what do you think is going on with the FDA?

發生了什麼事——你認為 FDA 發生了什麼？

What can we expect for the back half of the year?

今年下半年我們可以期待什麼？

Okay.

好的。

Thank you, Jami.

謝謝你，傑米。

You elegantly managed to squeeze in 3 questions, which we will answer.

您巧妙地提出了 3 個問題，我們將予以回答。

I'll take the first one, then Mike will take the one on the debt and then Brendan will comment on ANDA.

我將接受第一個，然後 Mike 將接受債務，然後 Brendan 將對 ANDA 發表評論。

You're absolutely right that the run rate right now is probably for next year something around $18 billion, and that gives the EBITDA you're talking about.

你說得對，明年的運行率可能在 180 億美元左右，這就是你所說的 EBITDA。

But that's just for next year.

但這只是明年。

And next year, as I've said before, that is, hopefully, the sort of a valley -- the bottom of a valley because, in September, we very much expect and hope to get the approval for AJOVY, and we think that, that's a fantastic market.

明年，正如我之前所說，希望是那種山谷——山谷的底部，因為在 9 月，我們非常期待並希望獲得 AJOVY 的批准，我們認為，這是一個很棒的市場。

The migraine market is very, very promising.

偏頭痛市場非常非常有前景。

We think there's enormous unmet need.

我們認為存在巨大的未滿足需求。

So with a good launch of AJOVY, that sales will start to accumulate in '19 and will be meaningful in 2020.

因此，隨著 AJOVY 的良好推出，銷售額將在 19 年開始積累，並將在 2020 年變得有意義。

Same thing for AUSTEDO.

AUSTEDO 也是如此。

We expect to continue to grow our sales.

我們希望繼續增長我們的銷售額。

Same thing for our respiratory and eConnected respiratory that we are expecting to bring to the market next year.

我們預計明年將推向市場的呼吸系統和 eConnected 呼吸系統也是如此。

So we're really seeing a situation where next year is a real tough restructuring year still, with COPAXONE sales coming down, with continued pressure on different parts of the business.

因此，我們確實看到明年仍然是艱難的重組年，COPAXONE 的銷量下降，業務的不同部分持續承受壓力。

But then based on good launches, based on good portfolio optimization of our generic business, we hope to see growth coming back in 2020.

但隨後基於良好的發布，基於我們通用業務的良好投資組合優化，我們希望在 2020 年看到增長回升。

And then maintaining the margins, of course, we do expect to see by then a growing EBITDA.

當然，然後保持利潤率，我們確實希望屆時 EBITDA 會有所增長。

But the reduction of the debt is really not hinging on strong growth of the EBITDA.

但債務的減少實際上並不取決於 EBITDA 的強勁增長。

We will reduce the nominal debt, no matter what.

無論如何，我們都會減少名義債務。

So that's not -- that's one long-term target is really not hinging on that.

所以那不是 - 這是一個長期目標，實際上並不依賴於此。

But, of course, the long-term projection for earnings is very much linked to us being able to start growing the top line again once we get to 2020.

但是，當然，對收益的長期預測與我們到 2020 年能夠再次開始增長收入密切相關。

So that was the first question.

所以這是第一個問題。

And then I'll turn over to Mike on the debt question.

然後我將在債務問題上交給邁克。

Yes.

是的。

So we've reported this quarter the $28.4 billion in net debt.

因此，我們在本季度報告了 284 億美元的淨債務。

If you look at the remainder of the free cash flow to go, you'd end up, depending on where currency goes, somewhere between $27.5 billion and $28 billion, depending on exchange rates.

如果您查看剩餘的自由現金流，根據匯率的不同，您最終會在 275 億美元和 280 億美元之間，具體取決於貨幣的去向。

For next year, we are still looking at a couple of assets that were in potential divestment.

對於明年，我們仍在關注可能撤資的幾項資產。

It's the Medis, it's a small asset here in Israel and a little OTC business in the U.S. So all in all, with that and free cash flow, we hope to be able to pay down anywhere from $2.5 billion to $3 billion again next year.

這是 Medis，它是以色列的一項小資產，也是美國的一項小型 OTC 業務。所以總而言之，憑藉這一點和自由現金流，我們希望明年能夠再次償還 25 億至 30 億美元。

And then as we go forward, we're still targeting to get at 4x by the end of 2020.

然後隨著我們的前進，我們的目標仍然是到 2020 年底達到 4 倍。

Of course, that will depend on how we do in growing the revenue after 2019, as Kåre just discussed.

當然，正如 Kåre 剛剛討論的那樣，這將取決於我們在 2019 年之後如何增加收入。

So we're still focusing all of our efforts in terms of generating cash and paying down debt.

因此，我們仍然將所有努力集中在產生現金和償還債務方面。

We've been very successful so far in the last 8 quarters.

到目前為止，在過去的 8 個季度中，我們一直非常成功。

We've paid down $7 billion.

我們已經支付了 70 億美元。

We want to continue to pay down.

我們想繼續償還。

And we won't be able to match that pace necessarily going forward, but we will continue to generate cash and pay down debt.

我們將無法在未來一定程度上跟上這一步伐，但我們將繼續產生現金並償還債務。

Brendan, I think you had the third part of the question?

布倫丹，我想你有問題的第三部分？

I did.

我做到了。

Jami, so your question was around ANDA approvals and what's going on with the FDA.

Jami，所以你的問題是關於 ANDA 批准以及 FDA 的情況。

And it's, obviously, hard to speculate what is transpiring with the FDA.

顯然，很難推測 FDA 正在發生什麼。

We came out of the gates pretty fast in the first quarter.

我們在第一季度很快就走出了大門。

We had 10 launches in Q1 .And so far -- and then 1 in Q2 and then so far 1 in Q3.

我們在第一季度發布了 10 次。到目前為止，第二季度有 1 次，第三季度到目前為止有 1 次。

So we expect throughout the remainder of the year that as we work through some of our different ANDA files with the FDA, we still have 10 to maybe 15 launches between now and the end of the year.

因此，我們預計在今年剩下的時間裡，當我們與 FDA 一起處理一些不同的 ANDA 文件時，從現在到年底，我們仍有 10 到 15 次發布。

So we'll see that number should start to tick up as we get into the second half.

因此，隨著我們進入下半場，我們會看到這個數字應該開始上升。

Okay.

好的。

Can I ask a follow-up question, Kåre?

我可以問一個後續問題嗎，Kåre？

Can I ask a follow-up question?

我可以問一個後續問題嗎？

Yes, quick one.

是的，快一個。

Okay.

好的。

The $18 billion that you talked about next year, is that -- do you think that is a trough sales number?

你談到明年的 180 億美元，是不是 - 你認為這是一個低谷的銷售數字嗎？

Yes, that's what I tried to explain that I think that we are probably hitting the bottom of a valley or a trough, whatever you want to call it, in '19.

是的，這就是我試圖解釋的，我認為我們可能正在觸及谷底或低谷，無論你想怎麼稱呼它，在 19 年。

And then based on the dynamics that COPAXONE is not dropping so much anymore because it's -- a big chunk of it is gone by then.

然後基於 COPAXONE 不再下降那麼多的動態，因為它的很大一部分到那時已經消失了。

And that AJOVY is picking up, AUSTEDO is picking up and I expect this to see a positive momentum on sales from 2020.

並且 AJOVY 正在回升，AUSTEDO 正在回升，我預計這將從 2020 年開始看到積極的銷售勢頭。

The next question today comes from the line of Chris Scott from JPMorgan.

今天的下一個問題來自摩根大通的 Chris Scott。

Kåre, I'm sure you handle around how we think about the -- first of all, appreciate the 27% margin target, but just how the P&L evolves over time?

Kåre，我敢肯定你會處理我們如何看待——首先，欣賞 27% 的保證金目標，但是隨著時間的推移，損益表是如何演變的？

So I guess, 2 questions.

所以我猜，2個問題。

One, with your gross margins, is there further manufacturing efficiencies from some of the efforts you're making beyond 2019?

第一，就您的毛利率而言，您在 2019 年之後所做的一些努力是否會進一步提高製造效率？

Or is the $3 billion expense kind of reduction capture a lot of that opportunity?

還是 30 億美元的開支削減抓住了很多機會？

So when we get kind of gross margins next year, is that a decent run rate?

那麼當我們明年獲得某種毛利率時，這是一個不錯的運行率嗎？

And then second question on longer-term plan.

然後是關於長期計劃的第二個問題。

When you figure out some of these R&D initiatives, whether it is biosimilars on the branded business, et cetera, can you do that within the existing $1 billion run rate R&D budget?

當您弄清楚其中一些研發計劃時，無論是品牌業務中的生物仿製藥等，您能否在現有的 10 億美元研發預算內做到這一點？

Or do we have to think about spend starting to increase over time as you start on some of those projects?

或者我們是否必須考慮隨著時間的推移開始增加一些項目的支出？

Okay.

好的。

Thank you, Chris, for those very interesting questions.

謝謝你，克里斯，這些非常有趣的問題。

So if we think about the margin overall and what can be done, you could say, longer term after 2019, then first of all, we have to realize that, in '19, there's continued pressure on the margin from the fact that COPAXONE is reducing in sales and the fact that we don't really see meaningful big sales of AJOVY yet coming in compensating for that.

因此，如果我們考慮整體利潤率以及可以做什麼，你可以說，在 2019 年之後的更長期，那麼首先，我們必須意識到，在 19 年，由於 COPAXONE 是銷售額下降，而且我們並沒有真正看到 AJOVY 的有意義的大額銷售，但這一事實彌補了這一點。

But, of course, longer term, there's a better gross margin on AJOVY and on AUSTEDO than there is on the bulk of our business.

但是，當然，從長遠來看，AJOVY 和 AUSTEDO 的毛利率要高於我們大部分業務的毛利率。

So longer term, that will sort of affect the margin in a positive way.

所以從長遠來看，這將以積極的方式影響利潤率。

In terms of our gross margin, then, of course, long term, there will continue to be possibilities for optimization.

就我們的毛利率而言，當然，從長遠來看，將繼續存在優化的可能性。

And it really comes from 2 places.

它真的來自兩個地方。

It comes from the manufacturing cost, that's a long-term game where you consolidate, you improve your way of running things, you mature, you move products to the right plant, you shut down plants that are no longer efficient or needed.

它來自製造成本，這是一場長期的博弈，你需要整合、改進運營方式、成熟、將產品轉移到正確的工廠、關閉不再有效或不再需要的工廠。

And in doing so, you can gradually improve your gross margin.

這樣做，您可以逐漸提高您的毛利率。

But it also comes from the portfolio management.

但它也來自投資組合管理。

If you manage your portfolio of products geographically and your portfolio of generics in each of the key markets and you manage the pricing of those products in a very good interactive way, then you also, of course, by improving the pricing environment improve your gross margin because it's both the manufacturing cost, but it is also the average pricing that goes into this calculation.

如果您在地理上管理您的產品組合和在每個主要市場的仿製藥組合，並且您以非常好的交互方式管理這些產品的定價，那麼您當然也可以通過改善定價環境來提高您的毛利率因為這既是製造成本，也是計算中的平均定價。

I'm convinced that we, as the biggest generic supplier worldwide, will be able to continuously optimize our skills in that area, both on the manufacturing side and on the pricing dynamics side.

我相信，作為全球最大的仿製藥供應商，我們將能夠在製造方面和定價動態方面不斷優化我們在該領域的技能。

But it's not a big splash like the $3 billion that we are cutting out of cost right now.

但這並不像我們現在削減的 30 億美元那樣引起轟動。

It's more gradual, but it will, of course, be our ambition to getting more efficient as we go forward and, therefore, also, after 2019, continue to see improvements on the gross margin, but not as big as the ones you're seeing now.

它更加漸進，但當然，這將是我們在前進的過程中提高效率的雄心壯志，因此，在 2019 年之後，毛利率繼續提高，但不如你現在的那麼大現在看到。

You have to remember what we're doing right now is really to offset the loss of COPAXONE, we're cutting out $3 billion basically to compensate for the loss of revenue in the sort of order of magnitude of $3 billion.

你必須記住，我們現在所做的實際上是為了抵消 COPAXONE 的損失，我們削減了 30 億美元，基本上是為了彌補大約 30 億美元的收入損失。

But we will continue to improve, and we will continue to work on getting the gross margins improved also after 2019.

但我們將繼續改進，我們將在 2019 年之後繼續努力提高毛利率。

Chris, you had one more, and if the $1 billion run rate is enough to support the biosimilars?

克里斯，你還有一個，如果 10 億美元的運行率足以支持生物仿製藥？

Yes.

是的。

And I should have answered that explicitly.

我應該明確地回答這個問題。

It is enough, yes, it is.

夠了，是的，夠了。

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

今天的下一個問題來自 Bernstein 的 Ronny Gal。

A couple of questions.

幾個問題。

The first, Kåre, for you.

第一個，Kåre，給你。

You're talking about saying basically all the operating lines of Teva, all the away from novel biologics to OTC to commodity broad line generics.

你說的基本上是梯瓦的所有運營線，從新穎的生物製劑到非處方藥，再到商品廣泛的仿製藥。

It seems like you're taking on a lot, and the question is as you're trying to narrow the focus and execute better, is there no room to think about stepping out of some of those lines?

看起來你承擔了很多，問題是當你試圖縮小焦點並更好地執行時，是否沒有空間考慮走出其中的一些界限？

And you've never made your own biologics.

而且您從未製造過自己的生物製劑。

And you need some basic art to actually develop novel medicine.

你需要一些基礎藝術才能真正開發出新藥。

Is this just kind of a temporary thing?

這只是暫時的事情嗎？

Are you just going to do what was done before, just better?

你只是要做以前做過的事情，更好嗎？

Or are you still going to take a further look at participation on those product lines before this essentially commitment to stay in this?

或者，在基本上承諾繼續參與之前，您是否仍將進一步研究參與這些產品線的情況？

And second for Brendan on fremanezumab.

第二個是 Brendan 在 fremanezumab 上。

It's more of a commercial question.

這更像是一個商業問題。

I'm seeing Amgen right now going and going very hard for share by giving the product for free for a while.

我看到安進現在通過免費提供產品一段時間來非常努力地分享。

And when I think what you'll have to do as the second or third entrant is essentially to do the same in order not to fall behind on share before the payers begin to narrow their access in 2020, 2021?

當我認為你作為第二或第三進入者必須做的基本上是做同樣的事情，以便在付款人在 2020 年、2021 年開始縮小他們的訪問範圍之前不落後於份額？

Should we think about the first kind of, call it, half year of fremanezumab in the market as essentially be a period when you're largely giving the product away in United States to capture a significant market share to be competitive when it comes to payers?

我們是否應該考慮第一種，稱之為，市場上半年的 fremanezumab 本質上是一個時期，你在美國主要放棄產品以獲取重要的市場份額以在支付者方面具有競爭力?

And none of you guys have mentioned it, so I'm going to sneak kind of 2.5 questions here.

你們都沒有提到它，所以我要在這裡偷偷問一下 2.5 個問題。

You haven't mentioned the OAI status of that facility.

您沒有提到該設施的 OAI 狀態。

Is that going to be official move?

這會是官方的舉動嗎？

Or is there a strong assumption that will happen and why?

或者是否有一個強烈的假設會發生，為什麼？

Which facility, Ronny?

哪個設施，羅尼？

The one -- the Celltrion facility that make fremanezumab.

一個——生產fremanezumab的Celltrion設施。

Thank you very much.

非常感謝。

I'll answer the first one and your half question as well, and then Brendan will comment on fremanezumab in the marketplace.

我也會回答第一個問題和你的一半問題，然後 Brendan 將評論市場上的 fremanezumab。

So you're correct that we're combining, you could say, all the revenue lines per market in order to optimize the profitability.

所以你是對的，我們正在合併每個市場的所有收入線，以優化盈利能力。

We need the profitability, basically, to generate the cash to pay down the debt.

基本上，我們需要盈利能力來產生現金來償還債務。

So we are going to sell off any chunks of the business.

因此，我們將出售任何部分業務。

We're going to integrate it, make sure that we get the scale benefits of having one back office organization, having a well structured sales force and just basically optimizing the revenues, reducing the cost, making sure we generate the cash flow.

我們將整合它，確保我們獲得擁有一個後台組織的規模效益，擁有一支結構良好的銷售隊伍，基本上優化收入，降低成本，確保我們產生現金流。

Now then when it gets to the R&D piece, we do actually have which -- I was actually also surprised when I joined the company, we do have excellent discovery research going on also in biologics.

現在，當涉及到研發部分時，我們確實擁有——當我加入公司時，我實際上也很驚訝，我們確實在生物製劑方面也進行了出色的發現研究。

We have activities in the U.S. East Coast, the U.S. West Coast, in Australia, in Europe.

我們在美國東海岸、美國西海岸、澳大利亞和歐洲都有活動。

So we have activities in biologics in many places.

所以我們在很多地方都有生物製品的活動。

And even though we have not sort of launched a fully homegrown biologics or biopharmaceutical, we have actually done all the bits and pieces, and we've taken products that are biologics through basically all the different steps, whether it's the early steps or the late steps.

儘管我們還沒有推出完全本土的生物製劑或生物製藥，但我們實際上已經完成了所有的零碎工作，並且我們已經通過基本上所有不同的步驟來生產生物製劑產品，無論是早期步驟還是後期步驟腳步。

And we are expanding and have expanded our capabilities, both in the development space in terms of pilot scale facilities, everything you need.

我們正在擴大並擴大我們的能力，無論是在試驗規模設施方面的發展空間，你需要的一切。

And also in the disease understanding, we do believe that when we talk about respiratory, when we talk about neurology, CNS, and when we talk about oncology, we do have internal experts who knows what they're talking about.

在疾病理解方面，我們確實相信，當我們談論呼吸、神經病學、中樞神經系統以及腫瘤學時，我們確實有內部專家知道他們在說什麼。

And we do have a chance of commercializing competitively because we have been commercializing in these areas for the last 10, 20 years.

我們確實有機會進行競爭性商業化，因為過去 10 年、20 年我們一直在這些領域進行商業化。

So that's really the thinking behind it, that we do think we have a good pace there.

所以這真的是它背後的想法，我們確實認為我們在那裡有很好的步伐。

And we know that we are not the leaders in biopharmaceuticals, we are not the leaders in biosimilars, but we are reasonably good player, and we have some reasonably good medical and commercial footholds that, we think, we can utilize to generate a really nice business base on these assets.

我們知道我們不是生物製藥的領導者，我們不是生物仿製藥的領導者，但我們是相當優秀的參與者，我們有一些相當好的醫療和商業立足點，我們認為，我們可以利用這些立足點來產生一個非常好的以這些資產為基礎的業務。

Then I'll also answer your half question on the Celltrion thing.

然後我也會回答你關於 Celltrion 的一半問題。

What I tried to say in my opening remarks was that there has been an inspection which was a combined PAI and reinspection of Celltrion based on the warning letter and based on our fremanezumab filing, and that inspection has taken place, and we are satisfied with the outcome.

我在開場白中試圖說的是，根據警告信和我們的 fremanezumab 備案，已經進行了一次 PAI 和 Celltrion 再檢查的組合檢查，並且已經進行了檢查，我們對結果。

And we still expect to get the approval mid-September, but, of course, this is FDA, so nobody can give any guarantees or promise anything, but that's what we are hoping for and that's what we're planning for.

我們仍然希望在 9 月中旬獲得批准，但是，當然，這是 FDA，所以沒有人可以提供任何保證或承諾任何事情，但這就是我們所希望的，也是我們計劃的。

And then that leads into your second or third question on the commercialization of fremanezumab, and I'll hand that over to Brendan.

然後就引出了關於fremanezumab 商業化的第二個或第三個問題，我將把它交給Brendan。

Ronny, the question on the frem and how the migraine market is going to evolve, so I think it depends on when you launch the product as you look at '18.

Ronny，關於 frem 的問題以及偏頭痛市場將如何發展，所以我認為這取決於你在 18 年推出產品的時間。

So I don't know that it really matters whether you are second or third to market because those products will be very close.

所以我不知道你是第二名還是第三名真的很重要，因為這些產品會非常接近。

Most of the payers right now are blocking Amgen's products.

現在大多數付款人都在阻止安進的產品。

So it's difficult to get reimbursement as they're looking at this market to form.

因此，當他們正在尋找這個市場形成時，很難獲得報銷。

So we're in conversations with the payers already for 2019.

因此，我們已經在與 2019 年的付款人進行對話。

I'm sure, Lilly is the same and, obviously, Amgen as well.

我敢肯定，禮來（Lilly）是一樣的，顯然，安進（Amgen）也是如此。

So I think their 6-month period is largely a reflection of when they launched.

所以我認為他們的 6 個月期間很大程度上反映了他們推出的時間。

We launch in late September.

我們在 9 月下旬推出。

If we launch in late September, then I don't think we have quite that long of a runway till the January formulary starts.

如果我們在 9 月下旬推出，那麼我認為在 1 月的處方集開始之前我們不會有那麼長的跑道。

So I don't know that I would think about frem as a 6-month period where we largely give away product.

所以我不知道我會將 frem 視為我們在很大程度上放棄產品的 6 個月期間。

But I would think that all of the products will have either some kind of free product sampling program for a couple of months so that they can work through the insurance coverage issues.

但我認為所有產品都會有幾個月的某種免費產品抽樣計劃，以便他們可以解決保險範圍問題。

But we believe that we'll be competitive there, we're confident in the molecule, we think it's a very good molecule, we think we've got a very good package that we put together.

但我們相信我們將在那裡具有競爭力，我們對分子充滿信心，我們認為這是一個非常好的分子，我們認為我們已經有了一個非常好的包裝。

So we're looking forward to the launch, looking forward to competing and think this is a really good space to be.

所以我們期待著發布，期待著競爭，並認為這是一個非常好的空間。

Next question today comes from the line of Greg Gilbert from Deutsche Bank.

今天的下一個問題來自德意志銀行的 Greg Gilbert。

Two strategic ones for you, Kåre.

Kåre 給你兩個戰略性的。

First, when you look at the limited uptake of generic COPAXONE for the generic players and the limited uptake of biosimilar Remicade for those players, does this trouble you at all in terms of the differentiated generic products you have in your portfolio and/or the biosimilars that you eventually hope to launch?

首先，當您看到仿製藥公司對仿製藥 COPAXONE 的有限吸收以及對這些參與者對生物仿製藥 Remicade 的有限吸收時，就您投資組合中的差異化仿製藥和/或生物仿製藥而言，這是否會給您帶來困擾您最終希望推出的產品？

Do you think the system needs to change or rebates need to go away?

您認為系統需要改變還是需要取消回扣？

Just trying to understand the rationale to make significant investments in these types of products if generic COPAXONE and biosimilar Remicade are sort of telling at all.

如果仿製藥 COPAXONE 和生物仿製藥 Remicade 能說明問題，只是試圖了解對這些類型的產品進行重大投資的理由。

And number two, in your generic industry or your generic strategy slide, you talked about the importance of API and OTC, but you did not mention, I don't think, distribution even though you own a unique distribution asset.

第二，在您的通用行業或通用戰略幻燈片中，您談到了 API 和 OTC 的重要性，但您沒有提到，我不認為，即使您擁有獨特的分銷資產。

Does that mean you don't see that as an important differentiator between yourselves and other manufacturers?

這是否意味著您不認為這是您與其他製造商之間的重要區別？

And if not, why not sell it if you could get a sort of leverage-enhancing price for it?

如果沒有，如果你能得到某種槓桿增強價格，為什麼不賣掉它呢？

Thank you, Greg, for 2 very interesting questions.

謝謝你，格雷格，提出 2 個非常有趣的問題。

So the first question around what is the chance really for getting meaningful profitability out of biologics or in biosimilars.

因此，第一個問題是關於從生物製劑或生物仿製藥中獲得有意義盈利的真正機會是什麼。

And my experience is that you can actually compete very well in, you could say, the branded generics, biosimilars space.

我的經驗是，你實際上可以在品牌仿製藥、生物仿製藥領域進行很好的競爭。

And this is something you can see in diabetes.

這是你可以在糖尿病中看到的。

You can see -- I know it's 505(b)s they are called, I guess.

你可以看到——我知道它們被稱為 505(b)s，我猜。

So it's not straight out biosimilars, but it's really the same.

所以它不是直接的生物仿製藥，但它確實是一樣的。

And you can -- you've also seen it in the growth hormone space.

你可以——你也在生長激素領域看到了它。

But there's a very specific thing you need to be aware of in order to compete, and that is, if you really want to make a good profitability out of it, you should not really just compete on price.

但是為了競爭，你需要注意一個非常具體的事情，那就是，如果你真的想從中獲得良好的盈利能力，你不應該真的只在價格上競爭。

You need to have the commercial setup already in place, so you know the key opinion leaders, they trust in your new product, you know the patients, you have patient support programs and so on.

您需要已經具備商業設置，因此您了解關鍵意見領袖，他們信任您的新產品，您了解患者，您有患者支持計劃等等。

So you can't just launch a biosimilar like you launch a generic and then hope to get share by just having the pharmacies switch the patients.

因此，您不能像推出仿製藥一樣推出生物仿製藥，然後希望通過讓藥店更換患者來獲得份額。

That's not going to work.

那是行不通的。

You need some kind of commercial backbone.

你需要某種商業骨幹。

But that also means that if you want to be successful, you should probably not do what Mylan is doing, just taking down the price because you need to have a reasonable price to get back your investments and to protect the patient support, the sales force that's really needed to gain volume share in these areas.

但這也意味著，如果你想成功，你可能不應該像邁蘭那樣做，只是降低價格，因為你需要有一個合理的價格來收回你的投資並保護患者的支持，銷售人員這確實需要在這些領域獲得銷量份額。

So I really personally believe I know how to do this.

所以我個人真的相信我知道如何做到這一點。

I'm sure, together with the U.S. sales and marketing organization, we will know how to do it.

我敢肯定，與美國銷售和營銷組織一起，我們將知道如何去做。

And we're going to prove it with the biosimilars that we're going to be launching that we have in-license from Celltrion.

我們將用我們將要推出的生物仿製藥來證明這一點，我們擁有 Celltrion 的許可。

So that was the answer to that question.

這就是那個問題的答案。

On the ANDA side, I would say that I do see ANDA as a strategically important asset to us because they are in distribution, they are the biggest secondary distributor, but maybe, Brendan, you can also give it a few comments.

在 ANDA 方面，我認為我確實將 ANDA 視為對我們具有重要戰略意義的資產，因為它們是分銷商，他們是最大的二級分銷商，但也許，布倫丹，你也可以給它一些評論。

Yes.

是的。

So I do think that the ANDA business is a differentiator for us.

所以我確實認為 ANDA 業務對我們來說是一個差異化因素。

I think it's a -- something that keeps coming up in the marketplace.

我認為這是一個不斷出現在市場上的東西。

It gives us a strategic advantage.

它為我們提供了戰略優勢。

And we look forward to continuing to grow that business.

我們期待繼續發展該業務。

The performance for the first couple of quarters has been pretty strong.

前幾個季度的表現相當強勁。

It was fueled by a strong flu season in Q1, and that has spilled over to Q2.

第一季度強勁的流感季節助長了這一趨勢，並且已經蔓延到第二季度。

It's a very opportunistic business so it ebbs and flows.

這是一個非常機會主義的業務，所以它起起落落。

But I think it is a solid asset that we want to continue to maintain and optimize.

但我認為這是我們希望繼續維護和優化的可靠資產。

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 had 2, if I may.

如果可以的話，我有 2 個。

First, on generics, it seems like your gross margin in the U.S., excluding COPAXONE, dropped from 48% in Q1 to 43% in Q2.

首先，在仿製藥方面，您在美國的毛利率（不包括 COPAXONE）似乎從第一季度的 48% 下降到第二季度的 43%。

I just wanted to understand the dynamic there, what's driving that.

我只是想了解那裡的動態，是什麼驅動了它。

It's clearly generics, but just what's specifically within that?

它顯然是泛型，但其中具體是什麼？

And secondly, on CGRP, you mentioned that inspections happened and you also mentioned you're satisfied with the outcomes.

其次，在 CGRP 上，您提到進行了檢查，並且您還提到您對結果感到滿意。

So my question is, can you give us some more color on whether or not you've got any feedback from FDA that makes you feel more satisfied?

所以我的問題是，你能否就你是否從 FDA 得到任何讓你感到更滿意的反饋給我們更多的顏色？

So thank you very much, Umer.

非常感謝你，Umer。

Mike will give you the answer on the gross margin first and then I'll take the other question after that.

邁克會先給你關於毛利率的答案，然後我再回答另一個問題。

Yes.

是的。

So there's a couple factors in the gross margin in North America that you're looking at in the press release.

因此，您在新聞稿中看到了北美毛利率的幾個因素。

COPAXONE was relatively stable, but you saw our QVAR was down.

COPAXONE 相對穩定，但您看到我們的 QVAR 下降了。

That's a high-margin product.

這是一個高利潤的產品。

In terms of the generics, we did see a little bit of a mix change, so that you're having a little bit lower margin in there.

就彷製藥而言，我們確實看到了一些混合變化，因此您的利潤率會降低一些。

You're also having a little bit of some recalls that we did on some minor products affecting that gross margin.

您還會對一些影響毛利率的次要產品進行一些召回。

So overall, that's probably closer to a more forward-looking run rate that you're going to see in there because we had an exceptionally strong quarter in Q1 in terms of mix and now we're getting back to a more of a normalized for the rest of the year.

因此，總體而言，這可能更接近於您將在那裡看到的更具前瞻性的運行率，因為我們在第一季度的混合方面表現異常強勁，現在我們正在回到一個更加正常化的今年剩下的時間。

And in terms of the inspection at Celltrion, I can't really give you any specifics on it, and it's not because we are in any extraordinary dialogue with the FDA.

至於在 Celltrion 的檢查，我真的不能給你任何細節，這並不是因為我們正在與 FDA 進行任何特別的對話。

We are in the normal dialogue that you have approaching your PDUFA date.

我們正在正常對話中，您已接近 PDUFA 日期。

But we are still optimistic of achieving the approval on the PDUFA date mid-September.

但我們仍對在 9 月中旬的 PDUFA 日期獲得批准持樂觀態度。

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。

First question for Brendan.

布倫丹的第一個問題。

Can you give us a sense where you are in terms of the portfolio optimization process within the U.S. generic business?

您能否告訴我們您在美國仿製藥業務中的投資組合優化流程方面處於什麼位置？

And specifically, I asked the question because last couple of quarters, you talked about basically holding on to roughly 15% share of the U.S. market and that's started to slip a little bit, I guess, in the last couple of months.

具體來說，我問這個問題是因為上幾個季度，你談到基本上保持在美國市場大約 15% 的份額，我猜，在過去的幾個月裡，這個份額開始有點下滑。

But if I think about other companies, they have gone through similar processes.

但如果我想想其他公司，他們也經歷過類似的過程。

They've taken about 2 years to play out.

他們花了大約 2 年的時間才完成比賽。

And there's been pretty significant reductions in their unit market share even though dollars have held in.

即使美元保持不變，他們的單位市場份額也有相當大的減少。

And I just sort of question how should we be thinking about Teva's market share on a unit versus dollar basis.

我只是有點疑問，我們應該如何考慮梯瓦的市場份額，單位是美元。

I mean, should we be surprised if market share falls to 10% or 11%?

我的意思是，如果市場份額下降到 10% 或 11%，我們應該感到驚訝嗎？

Or is that sort of realistic given, I guess, the process that's in place?

或者，我猜是那種現實的給定流程？

And follow-up question for Kåre, specifically, on your BD commentary early in the call.

以及 Kåre 的後續問題，特別是在電話會議早期關於您的 BD 評論。

I think I understand the gist of it, companies are not going to be spending large sums on revenue-generating assets companies or overvalued public biotechniques, but how do we think about in-license strategies around earlier or later-stage assets in terms of sort of building potential growth profile post 2020?

我想我理解它的要點，公司不會在創收資產公司或高估公共生物技術上花費大量資金，但我們如何考慮圍繞早期或後期資產的許可策略排序構建 2020 年後的潛在增長概況？

I mean, would we -- should we be surprised to see the company do biobucks deals for Phase III assets?

我的意思是，我們是否應該對看到該公司為 III 期資產進行 biobucks 交易感到驚訝？

Or do you think that even those types of structure, frankly, are just kind of overpriced in the current environment and you're going to be looking at more sort of Phase IIa, Phase IIb-type deals?

或者您是否認為即使是這些類型的結構，坦率地說，在當前環境下也只是定價過高，您會考慮更多類型的 IIa 階段、IIb 階段類型的交易嗎？

I'll take the first question here around the market share and the portfolio optimization process.

我將在這裡圍繞市場份額和投資組合優化過程提出第一個問題。

So we've largely completed that exercise with most of the customers, so I would call that complete.

因此，我們已經在很大程度上完成了與大多數客戶的練習，所以我稱之為完成。

And as we've said before, about 20% of the products we got price increases on, but about 80% of the products we'll rationalize and they'll move to other suppliers.

正如我們之前所說，大約 20% 的產品我們會漲價，但大約 80% 的產品我們會合理化，它們會轉移到其他供應商。

But that's not an immediate exercise.

但這不是一個立即的練習。

In some cases, they had inventories, we had API, we had inventories.

在某些情況下，他們有庫存，我們有 API，我們有庫存。

So that, to your point, it will bleed out over the first 2 quarters and maybe a couple in the coming quarters, so really won't be visible probably until Q3 or Q4.

因此，就您而言，它會在前兩個季度流血，可能會在接下來的幾個季度流血，所以可能要到第三季度或第四季度才能看到。

But as we do that, we're also launching new products.

但在我們這樣做的同時，我們也在推出新產品。

And many of the products that we rationalized, we had very low market share anyway.

我們合理化的許多產品，無論如何我們的市場份額都非常低。

So I don't think that you'll see really a big change in our market share.

所以我認為你不會看到我們的市場份額發生真正的大變化。

There may be a 1 percentage point fluctuation or so, but I don't think you're going to see a big phase in the market share based upon mix and based upon how it's playing out.

可能會有 1 個百分點左右的波動，但我認為你不會看到基於混合和如何發揮作用的市場份額的大階段。

So that would be my answer there.

所以這就是我的答案。

So Elliot, I'll give you a comment on the BD question.

所以Elliot，我會給你一個關於BD 問題的評論。

Very good question.

非常好的問題。

So the idea is to develop the portfolio, I would call it, organically, which basically means that, of course, we need to do in-licensing, but we will do it early.

所以這個想法是開發投資組合，我稱之為有機的，這基本上意味著，當然，我們需要進行許可，但我們會儘早進行。

So basically, we will not in-license Phase III assets, we will not acquire companies with assets in Phase III or just about to go into the marketplace.

所以基本上，我們不會獲得第三階段資產的許可，我們不會收購擁有第三階段資產或即將進入市場的公司。

We will look at things that are preclinical, Phase I, maybe early Phase II.

我們將研究臨床前、I 期，也許是 II 期早期的東西。

That means that the upfronts will be limited and that we will only be sort of accumulating financial liabilities on part of those acquisitions as we see success with the pipeline.

這意味著前期費用將是有限的，並且我們只會在部分收購中累積金融負債，因為我們看到管道取得成功。

So this is a longer-term strategy.

所以這是一個長期的策略。

It takes, of course, longer than it takes if you're buying stuff very late.

當然，如果你很晚才買東西，這需要更長的時間。

But it's also -- you should see it as this a strategy where the new biologics pipeline will start to come to the marketplace maybe 5, 6 years from now with the first assets.

但它也是——你應該將其視為一種策略，新的生物製劑管道可能會在 5、6 年後隨著第一批資產進入市場。

So it's not something that's going to change our growth pattern for the next 2 to 5 years.

因此，這不會改變我們未來 2 到 5 年的增長模式。

But it will, of course, preserve cash to reduce the debt.

但它當然會保留現金以減少債務。

The last question today comes from the line of Irina Koffler for Mizuho.

今天的最後一個問題來自瑞穗的 Irina Koffler。

I was wondering if you could provide an update on your fremanezumab data because of the recent positive results out at Pfizer.

我想知道您是否可以提供有關您的 fremanezumab 數據的更新，因為輝瑞公司最近取得了積極的結果。

And then the other question I had was on your retained earnings for the end of 2018.

然後我的另一個問題是關於 2018 年底的留存收益。

Do you expect that to be negative?

你認為這是負面的嗎？

And do you expect to pay your convertible bondholders in company's stock rather than dividend?

您是否希望以公司股票而不是股息支付可轉換債券持有人？

Irina, thank you very much for those 2 questions.

伊琳娜，非常感謝你提出這兩個問題。

I'll take the first one and then Mike will take the second one.

我會拿第一個，然後邁克會拿第二個。

So with regard to Fasinumab, we don't really have any comments to the Pfizer Lilly results.

所以關於 Fasinumab，我們對輝瑞禮來的結果沒有任何評論。

You could say that the situation is basically unchanged in the sense that there's an enormous unmet need for nonopioid therapy for pain in this patient group.

你可以說這種情況基本上沒有改變，因為在這個患者群體中，對非阿片類藥物治療疼痛的巨大需求尚未得到滿足。

There's a clear-cut efficacy on Fasinumab and also on the Pfizer Lilly drug.

Fasinumab 和輝瑞禮來（Pfizer Lilly）的藥物都有明確的療效。

And there is a safety issue that has been followed for many years by now where there is still no real clarification.

到目前為止，還有一個安全問題已經被關注了很多年，但仍然沒有真正的澄清。

So we are, of course, hoping that the longer-term trials, both the ones that we are conducting or rather we are conducting together with Regeneron, will come out with positive results, but we don't know.

因此，我們當然希望長期試驗，無論是我們正在進行的，還是我們與 Regeneron 一起進行的試驗，都能取得積極的結果，但我們不知道。

And I'm sure that Pfizer Lilly, they're holding the same for their longer-term studies that they also come out positive in terms of safety, but it's really too early to say.

而且我敢肯定，輝瑞禮來公司在長期研究中也持有相同的觀點，他們在安全性方面也取得了積極成果，但現在說還為時過早。

So I think that with our partner Regeneron, we are pursuing this.

因此，我認為與我們的合作夥伴 Regeneron 一起，我們正在追求這一點。

They're doing a great job on it and, of course, we hope for positive results.

他們在這方面做得很好，當然，我們希望取得積極的成果。

But being Phase III safety results, you never know until you have the real data.

但作為 III 期安全性結果，在獲得真實數據之前，您永遠不會知道。

And we don't have that as of now.

我們現在還沒有。

Yes, thanks, Kåre.

是的，謝謝，Kåre。

And Irina, on the retained earnings, we do expect to convert the mandatory convertible preferred shares into stock, and that's been included in the share count that we've used for the updated EPS guidance.

伊琳娜，關於留存收益，我們確實希望將強制性可轉換優先股轉換為股票，這已包含在我們用於更新每股收益指導的股票數量中。

So that's our view for now, and that's what's most likely to happen.

所以這是我們目前的看法，也是最有可能發生的事情。

Thank you very much for listening into this call, and have a nice day.

非常感謝您收聽這個電話，祝您有美好的一天。

Thank you very much.

非常感謝。

That does conclude the conference for today.

今天的會議到此結束。

For those of you wishing to review this conference, the replay facility can be accessed by dialing +44-3-333-009-785.

對於那些希望回顧本次會議的人，可以撥打 +44-3-333-009-785 訪問重播設施。

The reservation number is 6984104.

預訂號碼為 6984104。

Thanks for participating.

感謝您的參與。

You may all disconnect.

你們都可以斷開連接。