Teva Pharmaceutical Industries Ltd (TEVA) 2010 Q2 法說會逐字稿

Greetings and welcome to the Teva Pharmaceutical Industries Limited second quarter 2010 results conference call.

歡迎來到 Teva Pharmaceutical Industries Limited 2010 年第二季度業績電話會議。

At this time all participants are in a listen-only mode.

此時所有參與者都處於只聽模式。

A question and answer session will follow the formal presentation.

問答環節將在正式介紹之後進行。

(Operator Instructions).

（操作員說明）。

As a reminder this conference is being recorded.

提醒一下，這次會議正在錄製中。

It is now my pleasure to introduce your host, Elana Holzman, Senior Director of Investor Relations.

現在我很高興向您介紹主持人，投資者關係高級總監 Elana Holzman。

Thank you, Ms.

謝謝你，女士。

Holzman, you may begin.

霍爾茲曼，你可以開始了。

Thank you, Diego.

謝謝你，迭戈。

Good morning and afternoon everyone.

大家早上好，下午好。

Welcome to Teva's second quarter 2010 earnings conference call.

歡迎參加 Teva 2010 年第二季度收益電話會議。

We hope you have had a chance to review our press release which we issued earlier this morning.

我們希望您有機會閱讀我們今天上午早些時候發布的新聞稿。

A copy of the press release is available on our website at www.tevapharm.com.

新聞稿的副本可在我們的網站 www.tevapharm.com 上獲取。

Additionally we are conducting a live webcast of this call that is also available on our website.

此外，我們正在對本次電話會議進行網絡直播，我們的網站上也提供。

Today we are joined by Shlomo Yanai, President and CEO; Eyal Desheh, Chief Financial Officer; Bill Marth, President and CEO of Teva North America; Moshe Manor, Group Vice President Global Branded Products; Dr.

今天，總裁兼首席執行官 Shlomo Yanai 加入了我們的行列； Eyal Desheh，首席財務官；梯瓦北美公司總裁兼首席執行官 Bill Marth； Moshe Manor，全球品牌產品集團副總裁；博士

Gerard Van Odijk, President and CEO of Teva Europe; and Dr.

Teva Europe 總裁兼首席執行官 Gerard Van Odijk；和博士。

Ben-Zion Weiner, Teva's Chief R&D Officer.

Teva 首席研發官 Ben-Zion Weiner。

Shlomo and Eyal will begin by providing an overview of our results.

Shlomo 和 Eyal 將首先概述我們的結果。

Please note that Shlomo will be referring in his prepared comments to non-GAAP gross margin, operating profit, net income, and EPS.

請注意，Shlomo 將在他準備好的評論中提到非 GAAP 毛利率、營業利潤、淨收入和每股收益。

Eyal will provide additional detail on the items excluded from our non-GAAP results.

Eyal 將提供有關從我們的非 GAAP 結果中排除的項目的更多詳細信息。

We will then open the call for a question and answer period.

然後，我們將開啟問答環節。

Before we proceed with the call, I would like to remind everyone that the Safe Harbor language contained in today's press release also pertains to this conference call and webcast.

在我們繼續通話之前，我想提醒大家，今天新聞稿中包含的安全港語言也適用於本次電話會議和網絡廣播。

Shlomo?

什洛莫？

Thank you, Elana.

謝謝你，伊萊娜。

Welcome, everyone, and thank you for joining us today as we review Teva's results for the second quarter of 2010.

歡迎大家，並感謝你們今天加入我們，回顧 Teva 2010 年第二季度的業績。

This was an outstanding quarter for Teva.

對於 Teva 來說，這是一個出色的季度。

Indeed, it was our strongest quarter ever in terms of organic growth.

事實上，就有機增長而言，這是我們有史以來最強勁的一個季度。

Net sales reached $3.8 billion, breaking all previous records in local currency terms, with record gross margins of 59%.

淨銷售額達到 38 億美元，以當地貨幣計算打破了以往的所有記錄，毛利率達到創紀錄的 59%。

Quarterly operating profit reached a record $1.2 billion, a 22% increase over the second quarter of 2009.

季度營業利潤達到創紀錄的 12 億美元，比 2009 年第二季度增長 22%。

Net income in the quarter reached $981 million, a 32% increase over Q2 '09.

本季度淨收入達到 9.81 億美元，比 09 年第二季度增長 32%。

And for the first time EPS crossed the $1 mark to reach $1.08.

EPS 首次突破 1 美元大關，達到 1.08 美元。

Our free cash flow reached $700 million, an increase of 86% over Q2 '09.

我們的自由現金流達到 7 億美元，比 09 年第二季度增長 86%。

Teva's better than anticipated results in the second quarter were driven by superb performances across our many geographies and lines of business including especially strong sales in North America.

Teva 在第二季度的業績好於預期，這得益於我們在許多地區和業務線的出色表現，包括在北美的強勁銷售。

It was a great quarter for Teva in North America with record-breaking results, record sales of generics and record number of new product launches.

對於 Teva 在北美來說，這是一個偉大的季度，取得了破紀錄的業績、創紀錄的仿製藥銷售額和創紀錄的新產品發布數量。

Total sales in North America reached $2.5 billion, in Q2, up 17% over the second quarter of 2009.

第二季度北美的總銷售額達到 25 億美元，比 2009 年第二季度增長 17%。

We had sales of $1.5 billion in US generics, up 14% over the second quarter of 2009, and strong sales of our branded products.

我們在美國仿製藥的銷售額為 15 億美元，比 2009 年第二季度增長 14%，我們的品牌產品銷售強勁。

It was also an exceptionally busy quarter, with nine new launches, representing a brand value of over $7.5 billion.

這也是一個異常繁忙的季度，推出了 9 款新品，品牌價值超過 75 億美元。

This intensive pace has continued into the beginning of Q3, with our launch of Venlafaxine ER, our generic version of Effexor XR.

這種密集的步伐一直持續到第三季度初，我們推出了 Effexor XR 的通用版本 Venlafaxine ER。

Thanks to the efforts of our outstanding global team, within 24 hours of launching, over 25,000 pharmacies in the US were supplied with the product, ready to dispense to the patients.

在我們優秀的全球團隊的努力下，在推出後的 24 小時內，美國超過 25,000 家藥店獲得了該產品，隨時可以分發給患者。

This was also an excellent quarter for our European business, which, despite the challenging macro conditions in this region, reached sales of $811 million.

對於我們的歐洲業務來說，這也是一個出色的季度，儘管該地區的宏觀環境充滿挑戰，但我們的銷售額仍達到了 8.11 億美元。

Up 10% over Q2 '09 in local currency terms.

按當地貨幣計算，比 09 年第二季度增長 10%。

Sales were up in all our major European markets.

我們所有主要歐洲市場的銷售額都有所增長。

And nearly all our other European markets as well.

幾乎所有其他歐洲市場也是如此。

Growth was especially impressive in France, Italy and in the new World Cup winner, Spain, where sales grew by well over 20%.

法國、意大利和新的世界杯冠軍西班牙的增長尤其令人印象深刻，銷售額增長了 20% 以上。

I believe that our performance in Europe this quarter demonstrates Teva's strong capabilities in managing a complex business environment.

我相信我們本季度在歐洲的表現證明了 Teva 在管理複雜商業環境方面的強大能力。

The recent healthcare reforms in Europe do involve some pricing pressure in the short term.

歐洲最近的醫療改革確實在短期內涉及一些定價壓力。

But there is an outstanding opportunity over the longer term to increase generics penetration in these markets.

但從長遠來看，增加仿製藥在這些市場的滲透率是一個絕佳的機會。

Pricing pressure is something we are accustomed to in the intensely competitive US market for a long time.

長期以來，在競爭激烈的美國市場，定價壓力是我們習以為常的事情。

And it is a phenomenon that, as you know, Teva is adept at managing.

如您所知，Teva 擅長管理這種現象。

For all these reasons, we remain very optimistic about the future of our European business.

由於所有這些原因，我們對歐洲業務的未來仍然非常樂觀。

Let's turn now to our international business.

現在讓我們談談我們的國際業務。

Where sales reached $522 million, up 6% in local currencies over Q2 '09.

其中銷售額達到 5.22 億美元，按當地貨幣計算比 09 年第二季度增長 6%。

Our strong performance in markets including Latin America and Israel, were offset by weaker results in Russia during this quarter.

本季度我們在拉丁美洲和以色列等市場的強勁表現被俄羅斯較弱的業績所抵消。

Our results in Russia, one of the fastest growing markets where we continue to strengthen our market position, are simply a matter of the timing of tenders and the very large sales to governments which were especially strong in the first quarter of this year, as well as in the comparable second quarter of 2009.

我們在俄羅斯這個增長最快的市場之一，我們繼續加強我們的市場地位，這只是招標時間和向政府的大量銷售的問題，這在今年第一季度尤其強勁，以及與可比的 2009 年第二季度一樣。

Q2 was another outstanding quarter for our innovative business.

第二季度是我們創新業務的另一個出色季度。

Global end market sales of Copaxone, the world's leading therapy for the treatment of multiple sclerosis, grew by 13% over the second quarter of 2009 to reach $770 million.

世界領先的治療多發性硬化症的藥物 Copaxone 的全球終端市場銷售額比 2009 年第二季度增長了 13%，達到 7.7 億美元。

Copaxone sales in the US grew by 21%, and according to IMS data, Copaxone maintained its leading market position in the US with TRx of 40%.

Copaxone 在美國的銷售額增長了 21%，根據 IMS 數據，Copaxone 以 40% 的 TRx 保持其在美國的領先市場地位。

We are continuously working to develop new ways of improving the experience of patients taking Copaxone.

我們一直在努力開發新的方法來改善服用 Copaxone 的患者的體驗。

In April the FDA indicated that a supplemental new drug application, sNDA, for our lower injection volume of Copaxone had been accepted and the action date is January 1, 2011.

4 月，FDA 表示已接受針對我們較低注射量 Copaxone 的補充新藥申請 sNDA，行動日期為 2011 年 1 月 1 日。

And our GALA trial, which will examine a 40-milligram Glatiramer Acetate injection, dosed three times weekly, initiated patient recruitment during the second quarter of 2010.

我們的 GALA 試驗將檢查 40 毫克醋酸格拉替雷注射液，每週給藥 3 次，該試驗在 2010 年第二季度開始招募患者。

We are confident that Copaxone sales leadership over the last 10 years will continue and that its unsurpassed long-term efficacy, safety and tolerability established over one million years of patient experience, will enable Copaxone to remain well positioned even as new oral therapies come to market.

我們相信，Copaxone 在過去 10 年的銷售領導地位將繼續保持，並且其無與倫比的長期療效、安全性和耐受性建立在超過一百萬年的患者經驗中，將使 Copaxone 保持良好的地位，即使新的口服療法進入市場.

Clearly, physicians and patients will have to carefully weigh the risk against the benefits for emerging oral therapies which are associated with serious safety concerns.

顯然，醫生和患者必須仔細權衡與嚴重安全問題相關的新興口服療法的風險和益處。

Market research indicates that most physicians and patients will not rapidly adopt newer therapies until the risk-benefit profiles are more thoroughly understood.

市場研究表明，在更徹底地了解風險收益概況之前，大多數醫生和患者不會迅速採用更新的療法。

Research also reveals reluctance by physicians to switch therapy if a patient's disease is stable.

研究還表明，如果患者的疾病穩定，醫生也不願意改變治療方案。

I would like to take a moment to address the market's reaction last Friday to the approval of the generic Lovenox and the apparent link that has been made to Copaxone.

我想花點時間談談上週五市場對仿製藥 Lovenox 的批准以及與 Copaxone 的明顯聯繫的反應。

Our team has thoroughly reviewed the FDA's response to the citizen petition questioning the approval criteria for a generic Lovenox.

我們的團隊已經徹底審查了 FDA 對公民請願書的回應，該請願書質疑仿製藥 Lovenox 的批准標準。

We believe the Agency's response actually supports our position, and that in the case of Copaxone, and like some other complex molecules, there are no acceptable and reliable tests, either in humans or in animals, that can be relied upon, except for complete clinical tests which reflect the clinical outcomes in multiple sclerosis.

我們相信該機構的回應實際上支持了我們的立場，就 Copaxone 而言，與其他一些複雜分子一樣，除了完整的臨床試驗外，沒有可以信賴的可接受和可靠的人體或動物試驗反映多發性硬化症臨床結果的測試。

For this reason we believe that any company seeking to introduce a similar version of Copaxone will need to conduct a long placebo controlled clinical trial with measured clinical endpoints in a large patient population to establish safety and efficacy.

出於這個原因，我們認為任何尋求推出類似版本 Copaxone 的公司都需要進行長期的安慰劑對照臨床試驗，並在大量患者群體中測量臨床終點，以確定安全性和有效性。

And last but not least, all this has been reflected in our long-term strategic outlook which we presented to you in January.

最後但並非最不重要的一點是，所有這些都反映在我們 1 月份向您展示的長期戰略展望中。

As we told you then, our risk adjusted outlook assumes that Copaxone will peak midway through the planning period and gradually decline into the $2 billion range, accounting for only 6% of Teva's sales by the end of 2015.

正如我們當時告訴您的那樣，我們的風險調整後前景假設 Copaxone 將在規劃期中期達到頂峰並逐漸下降至 20 億美元的範圍，到 2015 年底僅佔 Teva 銷售額的 6%。

Just to remind you, we expect $31 billion in sales, of which $9 billion of sales will be branded sales by 2015.

提醒一下，到 2015 年，我們預計銷售額將達到 310 億美元，其中 90 億美元的銷售額將是品牌銷售額。

I would now like to take a moment, to highlight for you, some of the major strategic achievements of the quarter.

現在我想花點時間向您強調本季度的一些主要戰略成就。

As part of our ongoing efforts to continuously improve the level of service for Teva's customers, we opened two major new state of the art facilities during the quarter.

作為我們不斷提高 Teva 客戶服務水平的持續努力的一部分，我們在本季度開設了兩個主要的新設施。

In the Czech Republic we opened a new oral solid dose manufacturing plant, already approved by the FDA, where we will produce many of the large scale products for the US market.

我們在捷克共和國開設了一家新的口服固體製劑製造廠，該廠已獲得 FDA 批准，我們將在那裡生產許多面向美國市場的大規模產品。

The high quality and low cost production at this plant will enable us to further enhance our competitive position.

該工廠的高質量和低成本生產將使我們能夠進一步提高我們的競爭地位。

And in Hungary, where our main manufacturing site for the EU is based, we opened a massive packaging plant which will help us meet the growing needs of the many different markets we serve in Europe.

在我們面向歐盟的主要製造基地所在的匈牙利，我們開設了一家大型包裝廠，這將幫助我們滿足我們在歐洲服務的許多不同市場不斷增長的需求。

These last few months have been an exceptionally busy time for our European business, as we prepare for the closing and eventual integration of Ratiopharm into the Teva family.

過去幾個月對我們的歐洲業務來說異常忙碌，因為我們準備關閉 Ratiopharm 並將其最終整合到 Teva 家族中。

As we get to know Ratiopharm even better, our excitement continues to grow about the combination of the two companies and the tremendous opportunities that lie ahead for our European business.

隨著我們對 Ratiopharm 的了解越來越深入，我們對兩家公司的合併以及我們歐洲業務面臨的巨大機遇的興奮繼續增長。

I am pleased to announce, that we now expect the closing to take place earlier than we initially anticipated, and that we should close during the current quarter.

我很高興地宣布，我們現在預計關閉時間比我們最初預期的要早，並且我們應該在本季度關閉。

We are extremely pleased with the results of the first half of this year which have yielded revenues of more than $7.4 billion and EPS of $1.99.

我們對今年上半年的業績感到非常滿意，其收入超過 74 億美元，每股收益為 1.99 美元。

Based on our performance during the first half of the year, and our outlook for the third and fourth quarters, we now expect 2010 EPS in the range of $4.50 to $4.60.

根據我們上半年的業績以及我們對第三和第四季度的展望，我們現在預計 2010 年每股收益在 4.50 美元至 4.60 美元之間。

Compared to the previous range of $4.40 to $4.60.

與之前的 4.40 美元至 4.60 美元的範圍相比。

Thank you for your attention, and now, let us turn the call over to Eyal for a more detailed financial update.

感謝您的關注，現在，讓我們將電話轉給 Eyal 以獲得更詳細的財務更新。

Eyal?

埃亞爾？

Thank you, Shlomo, and good day to everyone.

謝謝你，Shlomo，祝大家有美好的一天。

I hope you have had an opportunity to review the press release we issued earlier today.

我希望您有機會閱讀我們今天早些時候發布的新聞稿。

As you can see, we reported an outstanding second quarter with record sales in local currencies as well as record gross profit, operating profit, net income and earnings per share on a GAAP and non-GAAP basis.

如您所見，我們報告了出色的第二季度，以當地貨幣計算的銷售額創下歷史新高，並且在 GAAP 和非 GAAP 基礎上創下了創紀錄的毛利潤、營業利潤、淨收入和每股收益。

Completing a very strong first half and heading to an excellent 2010.

完成非常強勁的上半年並邁向出色的 2010 年。

We also reported cash flow from operations of almost $1 billion, and free cash flow of $700 million, both representing substantial growth compared to Q2 last year.

我們還報告了近 10 億美元的運營現金流和 7 億美元的自由現金流，與去年第二季度相比均有大幅增長。

Before we delve into the numbers, I would like to touch on two technical topics.

在我們深入研究這些數字之前，我想談談兩個技術主題。

First, I would like to remind everyone that we are presenting GAAP and non-GAAP results.

首先，我想提醒大家，我們正在展示 GAAP 和非 GAAP 結果。

In our non-GAAP presentation, we have excluded the following items this quarter.

在我們的非 GAAP 演示文稿中，我們在本季度排除了以下項目。

Amortization of purchased intangible assets amounting to $130 million, of which $122 million are included in cost of goods sold.

所購無形資產的攤銷金額為 1.3 億美元，其中 1.22 億美元計入銷售成本。

And the remaining $8 million is sales and marketing expenses.

剩下的 800 萬美元是銷售和營銷費用。

Finance expenses of $123 million which reflect $147 million in expenses resulting from hedging activities in connection with the acquisition of Ratiopharm, net of finance income of $24 million resulting from sales of securities.

1.23 億美元的財務費用反映了與收購 Ratiopharm 有關的對沖活動產生的 1.47 億美元費用，扣除證券銷售產生的 2400 萬美元財務收入。

Restructuring costs of $11 million resulting mostly from closing a manufacturing facility in Ireland.

1100 萬美元的重組成本主要來自關閉愛爾蘭的製造工廠。

$5 million purchased R&D process.

500 萬美元購買了研發流程。

Impairment of assets of $3 million.

資產減值 300 萬美元。

And these expenses were offset by income of $23 million in connection with legal settlements.

這些費用被與法律和解有關的 2300 萬美元收入所抵消。

In addition, the related tax benefits of $65 million.

此外，相關稅收優惠為6500萬美元。

You should note that the items excluded in arriving to our non-GAAP results for the second quarter of 2009 are not identical to those in the current quarter.

您應該注意到，我們 2009 年第二季度的非公認會計原則結果中排除的項目與本季度的不相同。

Most notably, Q2 2009 included an inventory step-up in connection with the Barr acquisition and higher amortization of purchased intangible assets.

最值得注意的是，2009 年第二季度包括與 Barr 收購相關的庫存增加和所購無形資產的更高攤銷。

Please review our press release and related tables for the reconciliation of our GAAP numbers, and complete information.

請查看我們的新聞稿和相關表格，了解我們的 GAAP 數字和完整信息的對賬情況。

As indicated in the past, we present non-GAAP figures to show you how we, the management team, and our board, look at our financial results.

正如過去所指出的，我們提供非 GAAP 數據是為了向您展示我們、管理團隊和董事會如何看待我們的財務業績。

And second, foreign currency continued to play a significant role in our results.

其次，外幣繼續在我們的業績中發揮重要作用。

In the second quarter, foreign currency differences had a negative impact of approximately $52 million on sales, as compared to Q2, 2009.

與 2009 年第二季度相比，第二季度外匯差異對銷售額產生了大約 5200 萬美元的負面影響。

The impact on sales resulted primarily from the decline in the value of certain currencies relative to the US dollar, primarily the euro, the British pound and the Hungarian forint, which was partially offset by a decline in the value of the US dollar relative to other currencies, primarily the Canadian dollar, the Israeli shekel, and the Russian ruble.

對銷售的影響主要是由於某些貨幣相對於美元的價值下降，主要是歐元、英鎊和匈牙利福林，這部分被美元相對於其他貨幣的價值下降所抵消貨幣，主要是加元、以色列謝克爾和俄羅斯盧布。

Nonetheless the impact on operating profit continued to be negligible, this time on a positive side, with a positive contribution of $8 million.

儘管如此，對營業利潤的影響仍然可以忽略不計，這次是積極的，貢獻了 800 萬美元。

Teva's diverse geographical presence continues to provide us with a good natural hedge that mitigates much of the risk involved in currency fluctuation and minimizes the impact on our bottom line.

Teva 多元化的地理分佈繼續為我們提供良好的自然對沖，減輕貨幣波動所涉及的大部分風險，並將對我們底線的影響降至最低。

Before I review the P&L in more detail, one more comment on the impact of foreign -- that foreign exchange had on our balance sheet.

在我更詳細地審查損益表之前，再評論一下外匯對我們資產負債表的影響。

Namely on our equity.

即我們的股權。

The strength of the US dollar at June 30 versus March 31 primarily relative to the euro, the Hungarian forint, the Polish zloty, and the Czech koruna resulted in a negative impact of approximately $1 billion compared to the first quarter of 2010 due to translation differences of long term assets, mostly goodwill and other intangible assets, as well as cash balances held in euros.

由於換算差異，美元在 6 月 30 日相對於 3 月 31 日的強勢主要相對於歐元、匈牙利福林、波蘭茲羅提和捷克克朗造成了與 2010 年第一季度相比約 10 億美元的負面影響長期資產，主要是商譽和其他無形資產，以及以歐元持有的現金餘額。

However, in July, the weakening of the US dollar had already offset part of this negative impact of the exchange rate as of June 30.

然而，在 7 月份，美元的走弱已經抵消了截至 6 月 30 日匯率的部分負面影響。

Looking at our consolidated results for Q2, sales totaled $3.8 billion, an increase of 12% compared to Q2 last year.

從我們第二季度的綜合業績來看，銷售額總計 38 億美元，比去年第二季度增長 12%。

This growth is all organic, as there was no acquisition during the past 12 months period.

這種增長都是有機的，因為在過去 12 個月期間沒有收購。

North America, which grew 17%, delivered record generic product sales and strong profitability of the base business.

北美增長 17%，仿製藥銷售額創歷史新高，基礎業務盈利能力強勁。

Europe grew 4% in US dollars and 10% in local currency terms.

歐洲以美元計算增長 4%，以當地貨幣計算增長 10%。

Sales in international markets grew 1% in US dollars and 6% in local currencies term, and was influenced by the timing of Copaxone tenders in Russia.

國際市場銷售額以美元計算增長 1%，以當地貨幣計算增長 6%，這受到俄羅斯 Copaxone 招標時間的影響。

Non-GAAP operating income reached $1.2 billion, up 22% compared to Q2 2009, benefiting from strong gross margin and tight expense control.

非 GAAP 營業收入達到 12 億美元，比 2009 年第二季度增長 22%，這得益於強勁的毛利率和嚴格的費用控制。

Non-GAAP net income reached $981 million, up 32% compared to Q2 2009.

非 GAAP 淨收入達到 9.81 億美元，比 2009 年第二季度增長 32%。

Non-GAAP fully diluted earnings per share were $1.08, up 30% compared to Q2, 2009.

非 GAAP 完全攤薄每股收益為 1.08 美元，與 2009 年第二季度相比增長 30%。

Two housekeeping points related to earnings per share calculation.

與每股收益計算相關的兩個管理要點。

The weighted average share count for the fully diluted non-GAAP EPS was 921 million shares, and the addback for the non-GAAP EPS calculation was $11 million in the quarter.

本季度完全稀釋的非 GAAP 每股收益的加權平均股數為 9.21 億股，非 GAAP 每股收益計算的增加為 1100 萬美元。

Now, let's discuss profit margin and operating expenses.

現在，讓我們討論利潤率和運營費用。

Non-GAAP gross profit margin, which excludes amortization of purchased intangible assets was 59% in the reported quarter, compared to 58.5% in the second quarter last year.

報告季度的非美國通用會計準則毛利率（不包括已購無形資產的攤銷）為 59%，而去年第二季度為 58.5%。

Gross margin continued to benefit from contribution from new and recently launched generic products in the US, improved gross margin of the US generic base business and a contribution to sales of our innovative and branded franchises.

毛利率繼續受益於新的和最近在美國推出的仿製藥產品的貢獻、美國仿製藥基礎業務毛利率的提高以及對我們創新和品牌特許經營權銷售的貢獻。

Non-GAAP operating margin reached 31.6%, up 2.7 percentage points from 28.9% in Q2 2009.

非 GAAP 營業利潤率達到 31.6%，比 2009 年第二季度的 28.9% 上升 2.7 個百分點。

The increase resulted primarily from the termination of payments we made to Sanofi-Aventis over the past two years of 21%, of Copaxone in-market sales in the US and Canada which were recorded under sales and marketing.

增加的主要原因是我們在過去兩年中終止了向賽諾菲-安萬特支付的 21% 的 Copaxone 在美國和加拿大的市場銷售記錄在銷售和營銷項下。

Strong gross margin and lower G&A as a percentage of sales also contributed to the improvement in our operating margin.

強勁的毛利率和較低的 G&A 佔銷售額的百分比也有助於提高我們的營業利潤率。

Net R&D expenses reached $217 million, or 5.7% of sales, and was up 28% compared to Q2 2009.

淨研發費用達到 2.17 億美元，佔銷售額的 5.7%，比 2009 年第二季度增長 28%。

Gross R&D before reimbursement from third parties for certain R&D expenses were $227 million, or 6% of sales, up 8% compared to gross R&D in Q2 2009.

第三方為某些研發費用報銷前的研發總額為 2.27 億美元，佔銷售額的 6%，與 2009 年第二季度的研發總額相比增長了 8%。

The increase in R&D expenses relates mostly to our innovative and branded business, most notably women health products, the new low volume formulation of Copaxone for which filing was made with the US FDA and our BLA file for G-CSF.

研發費用的增加主要與我們的創新和品牌業務有關，最顯著的是女性保健產品、向美國 FDA 提交的新型低容量 Copaxone 製劑和我們的 G-CSF BLA 文件。

As we guided earlier in the year, for the full year we expect net R&D expenses to be between 6% to 6.5% of net sales.

正如我們今年早些時候的指導，我們預計全年淨研發費用將占淨銷售額的 6% 至 6.5%。

Sales and marketing expenses, excluding amortization of purchased intangible assets, totaled $636 million in the second quarter.

第二季度銷售和營銷費用（不包括已購無形資產的攤銷）總計 6.36 億美元。

Or 16.7% of sales compared to 18.9% of sales in Q2 2009.

或占銷售額的 16.7%，而 2009 年第二季度為 18.9%。

As already mentioned, the decline resulted primarily from the termination of payment to Sanofi-Aventis which were recorded in sales and marketing expenses, partially offset by higher royalty payments in connection with new and recently launched generic products in the US market.

如前所述，下降的主要原因是終止向賽諾菲-安萬特付款，這記在銷售和營銷費用中，部分被美國市場上新的和最近推出的仿製藥相關的特許權使用費增加部分抵消。

Total G&A expenses this quarter were $189 million, or 5% of sales, compared with 5.8% of sales in Q2 last year.

本季度總 G&A 費用為 1.89 億美元，佔銷售額的 5%，而去年第二季度佔銷售額的 5.8%。

The synergies from the Barr acquisition continued to contribute to the decline in G&A expenses, and to many other expense line items in our P&L.

收購 Barr 的協同效應繼續導致 G&A 費用的下降，以及我們損益表中許多其他費用項目的下降。

We recorded $25 million of net financial expenses on a non-GAAP basis in Q2, compared to $61 million of non-GAAP financial expenses in the comparable quarter of 2009.

我們在第二季度記錄了 2500 萬美元的非 GAAP 淨財務費用，而 2009 年同期的非 GAAP 財務費用為 6100 萬美元。

The lower financial expense resulted primarily from lower level of average debt through most of the quarter compared to the second quarter of 2009, as well as lower interest rate and higher gains from hedging activity unrelated to Ratiopharm.

較低的財務費用主要是由於與 2009 年第二季度相比本季度大部分時間的平均債務水平較低，以及較低的利率和與 Ratiopharm 無關的對沖活動的較高收益。

Excluded from our non-GAAP financial expenses in the quarter are $147 million incurred in connection with the hedging of the Ratiopharm acquisition and a gain of $24 million from the sales of securities.

本季度我們的非 GAAP 財務費用不包括與 Ratiopharm 收購的對沖相關的 1.47 億美元和證券銷售收益 2400 萬美元。

Following the agreement to acquire Ratiopharm, and as we indicated last quarter, we created a hedging program designed to protect the dollar value of the acquisition.

在達成收購 Ratiopharm 的協議之後，正如我們上個季度所指出的那樣，我們創建了一個旨在保護收購的美元價值的對沖計劃。

After accounting for $147 million in hedging expenses, the net savings from the acquisition price is approximately $270 million in US dollar terms compared to the price on the day we announced the acquisition.

在計入 1.47 億美元的對沖費用後，與我們宣布收購當天的價格相比，以美元計算，收購價格的淨節省約為 2.7 億美元。

In the third quarter upon settling this hedging transaction, we reversed approximately $40 million of these costs, which are expected to be recorded as income in Q3, but consistent with our current presentation will again be excluded from our non-GAAP results.

在第三季度結算此對沖交易後，我們扭轉了這些成本中的大約 4000 萬美元，這些成本預計將在第三季度記為收入，但與我們目前的陳述一致，將再次被排除在我們的非 GAAP 業績之外。

The tax expense provided for the second quarter was $183 million on pretax non-GAAP income of $1.176 billion.

第二季度的稅前非公認會計原則收入為 11.76 億美元，計提的稅費為 1.83 億美元。

Our current estimate of non-GAAP annual tax rate for 2010 is 15%.

我們目前對 2010 年非 GAAP 年度稅率的估計為 15%。

Compared to 16% for all of 2009.

與 2009 年全年的 16% 相比。

The estimated tax rate for 2010 GAAP results is 12%.

2010 年 GAAP 結果的估計稅率為 12%。

Now let's have a look at our cash flow.

現在讓我們來看看我們的現金流。

Cash generated from operations this quarter totaled $954 million, up 45% compared to Q2 2009.

本季度運營產生的現金總計 9.54 億美元，比 2009 年第二季度增長 45%。

Our free cash flow excluding gross capital expenditure of $136 million, and cash dividend of $164 million, partially offset by proceeds from sale of certain assets of $46 million, amounted to $700 million even, or 86% higher than in Q2, 2009.

我們的自由現金流不包括 1.36 億美元的總資本支出和 1.64 億美元的現金股息，部分被出售某些資產的收益 4600 萬美元抵消，總計甚至達到 7 億美元，比 2009 年第二季度高出 86%。

The improved cash flow was driven by strong collection and slight increase in working capital items this quarter.

本季度強勁的收款和營運資金項目的小幅增長推動了現金流的改善。

As you all know, in anticipation of the closing of the Ratiopharm acquisition we issued $2.5 billion principal amount of senior notes and signed three credit agreements with banks for a total commitment of $1.5 billion.

眾所周知，在預期 Ratiopharm 收購完成之前，我們發行了 25 億美元本金的優先票據，並與銀行簽署了三項信貸協議，總承諾額為 15 億美元。

On June 30 cash and marketable security totaled $5.2 billion, up approximately $2.2 billion from March 31, 2010.

截至 6 月 30 日，現金和有價證券總額為 52 億美元，比 2010 年 3 月 31 日增加了約 22 億美元。

Our total outstanding loans, bonds and convertible debentures stood at $7 billion, up from $5.4 billion as of the end of March.

我們的未償還貸款、債券和可轉換債券總額為 70 億美元，高於 3 月底的 54 億美元。

Our cash position as of the end of Q2 reflects the use of some of the cash we raised to pay down approximately $800 million of the more expensive Barr bank debt.

截至第二季度末，我們的現金狀況反映了我們使用部分籌集的現金來償還約 8 億美元的更昂貴的 Barr 銀行債務。

Our convertible debentures were reduced by $70 million this quarter and we intend to pay down the balance of the Barr debt approximately $700 million by the end of this year.

本季度我們的可轉換債券減少了 7000 萬美元，我們打算在今年年底前償還 Barr 債務的餘額約 7 億美元。

As a result our financial leverage as of June 30, 2010, was 27%.

因此，截至 2010 年 6 月 30 日，我們的財務槓桿率為 27%。

Similar to our leverage in Q2, but up from 22% in March 31.

與我們在第二季度的槓桿率相似，但高於 3 月 31 日的 22%。

DSO, days sales outstanding, amounted to 50 days this quarter compared to 53 days in Q1.

DSO，銷售未完成天數，本季度為 50 天，而第一季度為 53 天。

We calculated DSO after netting out from the receivables, our sales reserve and allowances.

我們在扣除應收賬款、銷售準備金和津貼後計算了 DSO。

Inventory days stood at 172 days, down from 183 days in the previous quarter.

庫存天數為 172 天，低於上一季度的 183 天。

Or down from 188 days in Q2, 2009.

或低於 2009 年第二季度的 188 天。

Net capital expenditure reached $90 million this quarter, compared to $164 million in Q1 2010.

本季度淨資本支出達到 9000 萬美元，而 2010 年第一季度為 1.64 億美元。

This quarter, net CapEx includes proceeds of $46 million from sales of certain assets.

本季度，淨資本支出包括出售某些資產的 4600 萬美元收益。

And last, dividend.

最後，股息。

Yesterday, Teva's board approved a quarterly dividend amounting to approximately $170 million.

昨天，Teva 董事會批准了總額約為 1.7 億美元的季度股息。

On a per share basis, our dividend which is declared in Israeli shekels, is 0.7 shekels per share.

按每股計算，我們以以色列謝克爾宣布的股息為每股 0.7 謝克爾。

Based on yesterday's rate of exchange of the shekel to the US dollar this translates into approximately $0.181 per share.

根據昨天謝克爾對美元的匯率，這相當於每股約 0.181 美元。

Thank you all for your time and attention today.

感謝大家今天的時間和關注。

Now we will be glad to take your questions.

現在我們很樂意回答您的問題。

(Operator Instructions).

（操作員說明）。

Our first question comes from Randall Stanicky with Goldman Sachs.

我們的第一個問題來自高盛的 Randall Stanicky。

Great, thanks for the questions.

太好了，感謝您的提問。

Just first for Eyal, a clarification.

首先對Eyal 進行澄清。

The updated guidance, that remains Teva standalone and does not yet reflect Ratiopharm, is that correct?

更新後的指南仍然是 Teva 獨立的，尚未反映 Ratiopharm，是否正確？

Yes, absolutely.

是的，一點沒錯。

As the exact date of the closing is still not known, we did not account for Ratiopharm results in this guidance and this is apples to apples with what you know in 2010 in general.

由於關閉的確切日期仍然未知，我們沒有在本指南中說明 Ratiopharm 的結果，這與您在 2010 年所知道的一般情況相同。

We of course, will provide an update.

我們當然會提供更新。

It will take us a little while to study the exact data of the company as right now our plans are based on due diligence information.

我們需要一些時間來研究公司的確切數據，因為目前我們的計劃是基於盡職調查信息。

And it always takes a little bit of time.

而且它總是需要一點時間。

We do expect this to have a positive impact on sales, of course.

當然，我們確實希望這會對銷售產生積極影響。

As to our earnings per share, probably be $0.02 or $0.03 below, but not more than that in the first period.

至於我們的每股收益，可能比第一期低 0.02 美元或 0.03 美元，但不會超過。

And of course, it will have a contribution in 2011, as we mentioned, when we announced the deal.

當然，正如我們在宣布交易時提到的，它將在 2011 年做出貢獻。

Okay great.

好，太棒了。

Then for Gerard.

然後是杰拉德。

With respect to what you reported, the 10% constant currency growth in Europe, can you just give us a sense of how much of the known pricing cut's reflected in that second quarter reported number at this point?

關於您報告的內容，即歐洲 10% 的貨幣持續增長，您能否告訴我們目前第二季度報告的數字反映了多少已知的降價？

Thank you, Randall, for the question.

謝謝蘭德爾提出的問題。

I think it is a complex question you're asking there because it is almost different for each market to answer.

我認為你在那裡問的是一個複雜的問題，因為每個市場的回答幾乎不同。

But I think I should start with saying, repeating what Shlomo said is that if you take it across the board, Teva has been able to demonstrate that our set-up in Europe makes us less vulnerable to some of the price dynamics in Europe.

但我想我應該首先說，重複 Shlomo 所說的，如果你全面考慮，Teva 已經能夠證明我們在歐洲的設置使我們不那麼容易受到歐洲某些價格動態的影響。

We know how to handle the complexity and the challenges that are coming from the clear price pressure that we see in Europe.

我們知道如何應對歐洲明顯的價格壓力所帶來的複雜性和挑戰。

I also think that we have learned, in tougher pricing environments like the US to handle this.

我還認為我們已經學會了在像美國這樣更嚴格的定價環境中處理這個問題。

If you look at it, it will stay with us, price pressure, but it has been with us for a long time and it will stay with us.

如果你看它，它會和我們在一起，價格壓力，但它已經和我們在一起很長時間了，它會和我們在一起。

We have seen prices going down in markets.

我們已經看到市場價格下跌。

But it has been over compensated by volume growth, and very clear that it has to do with our portfolio, which is quite well spread between OTC, with hospitals, with retail, with many other products.

但它已經被銷量增長過度補償，而且很明顯，這與我們的產品組合有關，它在非處方藥、醫院、零售和許多其他產品之間分佈得很好。

And also our geographies.

還有我們的地理位置。

We're not over-weighted in one place or the other.

我們沒有在一個地方或另一個地方過度加權。

We have a very nice, well spread portfolio with products and geographies.

我們有一個非常好的、分佈廣泛的產品組合，包括產品和地域。

On top of that, of course, we have our launches that give us the tools to respond to all of these challenges.

當然，最重要的是，我們的發佈為我們提供了應對所有這些挑戰的工具。

On top of that, we believe that the environment is helping us.

最重要的是，我們相信環境正在幫助我們。

There is volume growth in many, many places, which is very strong.

很多很多地方都有銷量增長，非常強勁。

And that is why I believe that it is for that that we can explain that our growth in this quarter was as good as it was.

這就是為什麼我認為我們可以解釋我們在本季度的增長和以前一樣好。

I am sure it will require every quarter a lot of hard work from us and very specific tailor-made answer to the different challenges and opportunities we see in the different geographies in Europe but it is very clear we're up to it.

我相信這將需要我們每個季度都付出大量努力，並針對我們在歐洲不同地區看到的不同挑戰和機遇提供非常具體的量身定制的答案，但很明顯我們已經做到了。

I am happy to give you a few examples but perhaps we can talk about that later in light of another question.

我很樂意給你舉幾個例子，但也許我們可以稍後再根據另一個問題進行討論。

Are there a couple of main regions or major countries that you can highlight or point to that the pricing cuts have been fully reflected, the known pricing cuts at this point?

是否有幾個主要地區或主要國家可以強調或指出降價已得到充分體現，目前已知的降價？

Well, in some places it's started and in some places it's not started.

那麼，有的地方開始了，有的地方還沒有開始。

I'll take the much spoken about example in Spain, for instance, in retail where we all know about the announced 35% price decrease on the gross prices, but also with limitation on discounts in the trade as part of that whole package.

我將以西班牙廣為人知的例子為例，例如，在零售業，我們都知道宣布的總價格下降 35%，但作為整個一攬子計劃的一部分，貿易折扣也受到限制。

As Shlomo reported, or I think Eyal it was, we had excellent growth.

正如 Shlomo 報導的那樣，或者我認為是 Eyal 報導的那樣，我們取得了出色的增長。

We have been growing nearly 20% in our retail in Spain in the period that all of these measures were kicking in Spain.

在西班牙實施所有這些措施期間，我們在西班牙的零售業增長了近 20%。

So, it has been absorbed.

所以，它被吸收了。

And despite that, we have been able to grow our business very strongly in a place like Spain.

儘管如此，我們已經能夠在西班牙這樣的地方非常強勁地發展我們的業務。

In other places like in Italy, it will take a bit more time.

在意大利等其他地方，這將需要更多時間。

It has just been announced, the 12.5% again on gross price.

剛公佈的，毛價又是12.5%。

In Germany, you see that some of these tenders are currently kicking in and where some companies have been gaining tenders last year and they see now some of the results in that, we know we have won some tenders in the first half of this year which will be kicking in terms of market share and volume growth next year, in the rest of this year of next year and therefore the price impact will be related to that.

在德國，你看到其中一些招標目前正在啟動，一些公司去年已經獲得招標，他們現在看到了一些結果，我們知道我們在今年上半年贏得了一些招標明年的市場份額和銷量增長將在今年剩餘時間和明年開始，因此價格影響將與此相關。

It is a very diverse picture across Europe.

整個歐洲的情況非常多樣化。

If I talk about Germany, I talk about the tender business but as you know a large chunk of the German market is not exposed to tenders.

如果我談論德國，我會談論招標業務，但正如你所知，德國市場的很大一部分並未參與招標。

So it is a segment in Germany that is under price pressure.

因此，德國的一個細分市場面臨價格壓力。

There are other segments that are feeling the pressure of price, but as I said, that is the sort of price pressure that we see coming in every year.

還有其他細分市場正在感受到價格壓力，但正如我所說，這就是我們每年都會看到的那種價格壓力。

Okay.

好的。

And France is reflected?

而法國是反映？

And France, in France we know that the government is going after some extra savings.

還有法國，在法國，我們知道政府正在尋求一些額外的儲蓄。

They haven't yet specifically announced, although the indication is they are going to go for a few specific therapeutic areas, and that hasn't yet kicked in and we expect a specific price decrease on some specific therapeutic areas, like they did last year.

他們還沒有具體宣布，儘管有跡象表明他們將進入一些特定的治療領域，而且還沒有開始，我們預計某些特定治療領域的具體價格會下降，就像他們去年所做的那樣.

Okay great.

好，太棒了。

Thanks very much for the color.

非常感謝你的顏色。

Our next question is from Rich Silver with Barclays Capital.

我們的下一個問題來自巴克萊資本的 Rich Silver。

Please state your question.

請說出你的問題。

The respiratory business in the quarter seemed stronger than we would have expected.

本季度的呼吸業務似乎比我們預期的要強勁。

Can you provide a little bit more detail on what is happening both in the US and overseas and what we can expect going forward?

您能否提供更多關於美國和海外正在發生的事情以及我們對未來的展望的更多細節？

And I have a second question.

我還有第二個問題。

Okay, so Bill, will you take the US please and then Moshe will follow by the international data -- or countries of the international part.

好的，Bill，請問美國，然後 Moshe 將跟隨國際數據——或國際部分的國家/地區。

Sure.

當然。

Good morning, Rich, and thanks for the question.

早上好，里奇，謝謝你的提問。

With respect to respiratory, obviously, as you've seen, ProAir has been holding around 50%.

關於呼吸系統，很明顯，正如您所見，ProAir 一直持有 50% 左右的股份。

So that's been very well.

所以一切都很好。

Then we have got some seasonally adjusted advantage because this is a particularly good season for us.

然後我們獲得了一些季節性調整後的優勢，因為這對我們來說是一個特別好的賽季。

And really, the strength of Qvar has been really exceptional.

真的，Qvar 的實力非常出色。

It's almost 20% of that category now, and so it has done very, very well and continues to grow.

它現在幾乎佔該類別的 20%，所以它做得非常非常好，並且還在繼續增長。

So I would say the ProAir really holds steady, and moves with the market, with the season, and Qvar is really showing just great strength for us.

所以我想說 ProAir 確實保持穩定，並隨著市場和季節而變化，而 Qvar 確實為我們展示了強大的力量。

So, with the seasonal strength that you cited, does that mean that in the coming quarter, we should not expect the same level of sales that we saw in this quarter?

那麼，根據您提到的季節性強勢，這是否意味著在下一季度，我們不應該期望與本季度看到的銷售水平相同？

Well, it is hard to say what's going to happen in Q3.

好吧，很難說第三季度會發生什麼。

It all depends on the weather and the season.

這完全取決於天氣和季節。

So right now the quarter seems to be pretty good.

所以現在這個季度似乎還不錯。

But we will see how it ends up.

但我們會看到它的結局。

We wish for Teva there was only one season in a year.

我們希望 Teva 一年只有一個季節。

Okay.

好的。

And then on the gross margin, the guidance that maybe Eyal had commented but I didn't hear, that the range had been 59% to 60%.

然後關於毛利率，可能是 Eyal 評論過但我沒有聽到的指導，範圍是 59% 到 60%。

Is that still the case for the full year guidance?

全年指導是否仍然如此？

Yes.

是的。

I believe so, Rich.

我相信是的，里奇。

I think that 59% as we reported this quarter, underscores the second half of the year with Venlafaxine coming in.

我認為我們本季度報告的 59% 強調了下半年文拉法辛的加入。

You could see some improvement there, and I think what we have guided at the beginning of the year is pretty valid.

你可以在那裡看到一些改進，我認為我們在今年年初的指導是非常有效的。

Okay.

好的。

And then lastly, I know you haven't provided 2011 guidance yet, but specific to Venlafaxine, are you assuming additional competition in January?

最後，我知道你還沒有提供 2011 年的指導，但具體到文拉法辛，你是否假設 1 月份會有額外的競爭？

I think it is too early to answer this question unless, Bill, you would like to add something here.

我認為現在回答這個問題還為時過早，除非 Bill 您想在這裡添加一些內容。

Well, I would just add that it is too early to answer that question.

好吧，我只想補充一點，現在回答這個問題還為時過早。

So I concur.

所以我同意。

Just wait, Rich, we will get there.

等一下，里奇，我們會到達那裡的。

Our next question comes from Chris Schott with JPMorgan Chase & Co.

我們的下一個問題來自摩根大通公司的 Chris Schott。

Please state your question.

請說出你的問題。

Great.

偉大的。

Thanks.

謝謝。

The first question was just a follow up on Europe.

第一個問題只是關於歐洲的後續問題。

I think you have averaged about 5% constant currency growth for the first half of this year.

我認為今年上半年的平均貨幣增長率約為 5%。

When we consider the mix of further price cuts, as well as potential new launches and volume growth, is that 5% type of growth rate we are seeing so far this year a decent proxy of what you are anticipating for the second half?

當我們考慮進一步降價以及潛在的新產品發布和銷量增長的組合時，我們今年到目前為止看到的 5% 的增長率是否能很好地代表您對下半年的預期？

And I just have a quick follow up after that.

之後我會快速跟進。

Gerard?

杰拉德？

I think the second half of last year was a very good second half.

我認為去年下半年是一個非常好的下半年。

And although we are anticipating continued price pressure as we spoke about earlier, I would assume that we would be able to stay in the same sort of growth range as we have been doing so far.

儘管我們預計正如我們之前所說的那樣，價格壓力會持續存在，但我認為我們能夠保持與迄今為止相同的增長范圍。

Then my -- first, the updated guidance, can you just talk a little bit about the earnings progression as we think about 3Q and 4Q given the generic effects or launch this quarter, and number of potential opportunities if you think about 4Q?

那麼我的——首先，更新後的指導意見，你能不能談談我們考慮第三季度和第四季度的收益進展，考慮到本季度的一般影響或推出，以及如果你考慮第四季度的潛在機會數量？

Should we be thinking about 3Q and 4Q as roughly equal quarters, or are you anticipating one is going to be meaningfully above the other?

我們是否應該將 3Q 和 4Q 視為大致相等的四分之一，或者您是否預計其中一個將有意義地高於另一個？

Thanks.

謝謝。

We have very little choice but to return to our old type of describing our market as a market with many moving parts.

我們別無選擇，只能回到我們的舊模式，將我們的市場描述為一個有許多活動部件的市場。

That is throughout the second half.

這是整個下半場。

Generally, we could see the rest of the earnings per share for the second half split more or less even between the quarters but could definitely, we could definitely see a couple of cents moving from one quarter to another, depending on timing of launches, demand in the market, how it is allocated over the period.

一般來說，我們可以看到下半年剩餘的每股收益或多或少地在兩個季度之間分配，但可以肯定的是，我們可以肯定地看到幾美分從一個季度轉移到另一個季度，具體取決於發佈時間、需求在市場上，它在這段時間內是如何分配的。

And of course this does not include the Ratiopharm impact.

當然，這不包括 Ratiopharm 的影響。

So I would calculate this more or less even, plus or minus $0.02 it could move.

所以我會或多或少地計算這個，加上或減去它可能移動的 0.02 美元。

Thank you.

謝謝你。

Our next question comes from Ken Cacciatore with Cowen and Company.

我們的下一個問題來自 Cowen and Company 的 Ken Cacciatore。

Please state your question.

請說出你的問題。

Thanks.

謝謝。

I was wondering if you all could give us a little bit of sense of what the Lovenox citizen's petition taught you about your own Lovenox filing?

我想知道你們是否可以讓我們了解一下 Lovenox 公民的請願書對你們自己的 Lovenox 申請有何啟示？

Is there anything you saw in that that now you can go back and address, or are you in interactions with the Agency?

您是否看到了現在可以返回並解決的任何問題，或者您是否正在與該機構進行互動？

And as well, Shlomo, your commentary about some of the teachings in the Lovenox citizen's petition, vis-a-vis Copaxone, how do you think the FDA is going to address some of these potential deficiencies?

還有，Shlomo，你對 Lovenox 公民請願書中的一些教義的評論，相對於 Copaxone，你認為 FDA 將如何解決這些潛在的缺陷？

Do you think they will have to solicit expert commentary or open up to the public to help address maybe the mechanisms and assays that should be utilized on Copaxone?

您認為他們是否必須徵求專家評論或向公眾開放以幫助解決可能應該在 Copaxone 上使用的機制和分析？

Thank you.

謝謝你。

Okay.

好的。

So Bill, you take this one and then Benzi we will follow to complete the answer to this question.

所以Bill，你拿這個，然後Benzi 我們會跟著完成這個問題的答案。

Good morning, Ken, and thanks for the question.

早上好，肯，謝謝你的提問。

With respect to our Lovenox file, we are continuing to dialogue with the Agency.

關於我們的 Lovenox 檔案，我們正在繼續與原子能機構對話。

I would say to you that we feel that we are on track, we are progressing ahead.

我想對你說，我們覺得我們走在正軌上，我們正在前進。

We did file slightly later, about a month later than Momenta on the response to the immunogenicity which is very likely why we haven't received our notification yet.

我們確實稍微晚了一點，比 Momenta 晚了大約一個月對免疫原性的反應，這很可能是我們尚未收到通知的原因。

But as we review the five criteria, we find that our product falls clearly within the range that we believe is approvable.

但是當我們審查這五個標準時，我們發現我們的產品明顯落在我們認為可以批准的範圍內。

Now, of course, we have to let the FDA, they're going to have to give us their opinion, as well.

現在，當然，我們必須讓 FDA，他們也必須給我們他們的意見。

But the fact of the matter is, as we read through this, we think we hit all the criteria very, very well and it is just a timing issue.

但事實是，當我們閱讀本文時，我們認為我們非常非常好地達到了所有標準，這只是時間問題。

Benzi, would you like to add on?

奔子，你要補充嗎？

Yes.

是的。

Relevance to the correlation between Lovenox and Copaxone, I don't think there's a direct correlation between approval of Lovenox and future generic approval of Copaxone.

關於 Lovenox 和 Copaxone 之間的相關性，我認為 Lovenox 的批准與 Copaxone 的未來通用批准之間沒有直接關聯。

The FDA had issued five criteria by which Lovenox has to follow and then get approval.

FDA 已經發布了五項標準，Lovenox 必須遵循這些標準才能獲得批准。

Three of those have to do with the actual material, physical chemical aspects for the fragments, et cetera.

其中三個與碎片的實際材料、物理化學方面等有關。

I won't go into details on this you won't need.

我不會詳細介紹你不需要的。

And the two criteria that have to do with biological assays and tests and human exposure.

這兩個標準與生物分析和測試以及人體接觸有關。

And I think Copaxone is very different from Lovenox in the first part, in the three criteria that have to do with the actual product and primarily with the two biological ones.

我認為 Copaxone 在第一部分與 Lovenox 有很大不同，在與實際產品有關的三個標準中，主要與兩個生物標準有關。

The first three with Lovenox is the parent compound is obviously heparin, known chemical and known product for 90 years.

前三個與 Lovenox 的母體化合物顯然是肝素，90 年來已知的化學品和已知產品。

The structure is known, activity is known.

結構已知，活性已知。

And Copaxone is obviously a very different molecule based on random polymerization, a four amino acid structure, is not very clear.

而Copaxone顯然是一種非常不同的基於隨機聚合的分子，一個四氨基酸結構，不是很清楚。

There's no specific epitope through which the activity can be explained.

沒有可以解釋活動的特定表位。

And I won't go into details about the series of polypeptides and the number of repeating units in the Lovenox.

我不會詳細介紹 Lovenox 中的多肽系列和重複單元數。

What is very important to note here is that Lovenox, the assays through which FDA approved Lovenox, is based on very simple, straightforward, acceptable tasks that everybody can do, which are directly related to the target organ which is the blood.

這裡需要特別注意的是，Lovenox，即 FDA 批准 Lovenox 的化驗，是基於非常簡單、直接、可接受的每個人都可以完成的任務，這些任務與目標器官（即血液）直接相關。

Copaxone target organ is the brain.

Copaxone的靶器官是大腦。

There's no direct correlation between the mechanism of action of Copaxone which has to do with influencing immune cells and the target activity in the brain.

與影響免疫細胞有關的 Copaxone 作用機制與大腦中的目標活動之間沒有直接關聯。

So, in my mind, and other people mind, there's no direct substitution to a proper clinical trial conducted on MS patients with clinical end points.

因此，在我和其他人看來，沒有直接替代對具有臨床終點的 MS 患者進行的適當臨床試驗。

In my mind there's no good way to demonstrate safety and efficacy unless such a clinical trial is being performed.

在我看來，除非進行這樣的臨床試驗，否則沒有好的方法可以證明安全性和有效性。

No PK, no PD, and no biological assays can substitute this notion.

沒有 PK、沒有 PD 和沒有生物測定可以替代這個概念。

Great.

偉大的。

Very helpful.

非常有幫助。

Bill, just to finalize, can you talk about the Irvine facility, any update there?

比爾，最後，你能談談爾灣工廠，那裡有什麼更新嗎？

The Irvine facility, we continue to work with the Agency.

歐文設施，我們繼續與原子能機構合作。

We have released 12 products to date in cooperation with the FDA, and we are continuing to work with them on a daily basis to bring that facility up.

迄今為止，我們已經與 FDA 合作發布了 12 種產品，並且我們每天都在繼續與他們合作以提升該設施。

I would remind that any of the big launches that people are concerned about, enoxaparin, is not tied to the Irvine facility.

我要提醒的是，人們關注的任何大型發射，依諾肝素，都與爾灣設施無關。

Or gemcitabine, for that matter, is also a product that can be manufactured elsewhere (multiple speakers) we have our final approval.

或者吉西他濱，就此而言，也是一種可以在其他地方（多個揚聲器）製造的產品，我們得到了最終批准。

Thanks.

謝謝。

Our next question comes from Ronny Gal with Sanford Bernstein.

我們的下一個問題來自 Ronny Gal 和 Sanford Bernstein。

Please state your question.

請說出你的問題。

Good morning and thank you for taking my question.

早上好，謝謝你提出我的問題。

A couple of them, one around the filing of the low volume Copaxone.

其中有幾個，一個是關於小容量 Copaxone 的備案。

Do you happen to have any update of whether the product will be titled for three year exclusivity?

您是否碰巧有關於該產品是否會獲得三年獨占權的最新消息？

And second, a little bit of -- if you can give us a little bit about how you are thinking about the risk that you currently have with Protonix and the chances of exclusivity on Aricept.

其次，一點——如果你能給我們一點關於你如何看待你目前對 Protonix 的風險以及對 Aricept 的排他性機會的看法。

Bill, can you take the second one and then you will take -- you, Moshe, the first one?

Bill，你能不能先拿第二個，然後你再拿——你，Moshe，第一個？

Okay, Moshe, do you want to go first?

好的，摩西，你要先走嗎？

Yes.

是的。

Well, on one, as you probably know, we have submitted the file of the 0.5 ml, and the file was accepted by the FDA with the action date that was mentioned in the January 1st, 2011.

好吧，首先，正如您可能知道的那樣，我們已經提交了 0.5 毫升的文件，該文件已被 FDA 接受，其行動日期為 2011 年 1 月 1 日。

Of course I think it is too early to comment on the question that you asked about exclusivity.

當然，我認為現在評論您提出的有關排他性的問題還為時過早。

We definitely -- we have a good data there that show that the 0.5 ml is associated with less local site reaction and pain, local pain and that's something that we are going to discuss with the FDA, and with relation to the potential pre exclusivity, to the low volume product.

我們肯定 - 我們那裡有一個很好的數據表明 0.5 毫升與較少的局部反應和疼痛相關，局部疼痛，這是我們將與 FDA 討論的事情，以及與潛在的預排他性相關的問題，到小批量產品。

But you would not know the answer to that until January 1st?

但您要到 1 月 1 日才能知道答案？

Or would you know the answer before that?

或者你會在那之前知道答案嗎？

I don't think that we will know the answer.

我不認為我們會知道答案。

I don't believe that we will know the answer before January 1st to this question.

我不相信我們會在 1 月 1 日之前知道這個問題的答案。

Unless the FDA will give us the answer earlier.

除非FDA早點給我們答案。

Bill, can you answer the second one on the Protonix?

Bill，你能回答 Protonix 上的第二個問題嗎？

Yes, let's talk about the last two questions, Ronny, the Protonix and the donepezil.

是的，讓我們談談最後兩個問題，Ronny，Protonix 和多奈哌齊。

On Protonix, we go back to that and say I think it is a little early to talk about damages on Protonix because we still believe we have a very long way to go here.

在 Protonix 上，我們回到那個問題並說我認為現在談論 Protonix 的損壞還為時過早，因為我們仍然相信我們還有很長的路要走。

Although, obviously we don't agree with the judge and at the appropriate time we will appeal that decision.

雖然，顯然我們不同意法官的意見，但我們會在適當的時候對該決定提出上訴。

We still have two defenses that remain alive out there, the patent misuse and the unclean hands.

我們仍然有兩種防禦措施仍然存在，專利濫用和不潔之手。

So we will still pursue those with full vigor and we will be looking for discovery in those particular areas.

所以我們仍然會追求那些充滿活力的人，我們會在那些特定的領域尋找發現。

So I think we're a long way away from that on Protonix.

所以我認為我們在 Protonix 上還有很長的路要走。

On the donepezil, I can recount to you where we are at.

關於多奈哌齊，我可以向你講述我們的處境。

You know we have actually two files but our first file, we have a final approval on that file.

你知道我們實際上有兩個文件，但我們的第一個文件，我們對那個文件有最終批准。

We believe we are first to file on the compound patent.

我們相信我們是第一個申請化合物專利的人。

We believe we are entitled to exclusivity.

我們相信我們有權享有排他性。

We maintain that position.

我們保持這一立場。

Of course, Ranbaxy challenges that, but we beg to defer -- to differ to that view.

當然，Ranbaxy 對此提出了質疑，但我們請求推遲 - 與該觀點不同。

And so we are just proceeding.

所以我們只是繼續。

So what decision needs to take place?

那麼需要做出什麼決定呢？

Is that in that FDA hands?

那是在 FDA 手中嗎？

Is it in courts?

是在法庭上嗎？

Where does that stand and what is the timeline to approving this -- to resolving that question?

那是什麼情況？批准這一點以解決該問題的時間表是什麼時候？

Well, we don't know what's going to happen at this point in time.

好吧，我們不知道此時會發生什麼。

Obviously we think the decision will be in the hands of the FDA.

顯然，我們認為決定權在 FDA 手中。

There's no issue with the court, so --

法庭沒有問題，所以——

Thank you.

謝謝你。

Our next question comes from David Amsellem with Piper Jaffray.

我們的下一個問題來自 Piper Jaffray 的 David Amsellem。

Please state your question.

請說出你的問題。

Thanks.

謝謝。

Just a couple.

只是一對。

First on Copaxone, do you think you're getting to a point, in the US at least, where you won't be able to be as aggressive in raising prices?

首先，關於 Copaxone，您是否認為您已經到了一個地步，至少在美國，您將無法在提價方面如此激進？

And just talk about what you think the long-term outlook on price increases are for Copaxone and how you are thinking about that, at least in the US?

談談你認為 Copaxone 價格上漲的長期前景是什麼，以及你是如何考慮的，至少在美國是這樣？

Bill, would you like to take this one?

比爾，你要這個嗎？

Yes, thanks for the question, David.

是的，謝謝大衛的提問。

You bring up an excellent question about Copaxone and the pricing.

你提出了一個關於 Copaxone 和定價的很好的問題。

We did take another price increase this quarter.

本季度我們確實再次提價。

And as we move forward, we begin to wonder about where those price increases will lead us to.

隨著我們向前邁進，我們開始想知道這些價格上漲會將我們引向何方。

But frankly you have seen the competition raise their price, as well.

但坦率地說，您已經看到競爭對手也提高了價格。

So price in this particular area seems to go up.

所以這個特定區域的價格似乎上漲了。

I would tend to agree with you that I would not be as aggressive in the future on my pricing.

我傾向於同意你的觀點，即我在未來的定價上不會那麼激進。

But we will have to see.

但我們必須拭目以待。

My concern has always been Teva is, generally speaking, not a price leader.

我一直擔心的是，一般來說，Teva 不是價格領導者。

We are a price follower.

我們是價格追隨者。

What I can't tolerate is a situation where what I believe is the standard of care in this particular therapy and the leading product in the US and global markets to be disadvantaged on price.

我不能容忍的情況是，我認為這種特定療法的護理標準以及美國和全球市場的領先產品在價格上處於劣勢。

So we will continue to watch that as we move forward and just follow the market.

因此，我們將繼續關注這一點，因為我們會繼續前進並跟隨市場。

Okay.

好的。

Then just the second question is about competition from the orals and specifically Gilenia.

那麼第二個問題是關於口試的競爭，特別是 Gilenia。

What's your market research telling you regarding the willingness of doctors to potentially use Gilenia in the earlier stage patients?

關於醫生是否願意在早期患者中潛在使用 Gilenia，您的市場調查告訴您什麼？

Do you expect that Gilenia will largely -- at least initially will see usage in treatment failures and potentially switches from Tysabri?

您是否預計 Gilenia 會在很大程度上——至少最初會看到用於治療失敗並可能從 Tysabri 轉換？

Just I guess talk about what your research has been telling you there.

我想談談您的研究在那裡告訴您的內容。

Well, based on our research and discussion, extensive discussion actually, with opinion leader, we believe the orals and specifically Gilenia will enjoy slower, really slow uptake.

好吧，根據我們的研究和討論，實際上是與意見領袖的廣泛討論，我們相信口頭，特別是 Gilenia 會享受更慢，真的很慢的吸收。

The reason I believe is the -- is first of all, the physician -- sorry -- patient, most of the patients on Copaxone are stable, which they're doing well and we don't see the rationale to switching patients that are doing well to a product that is really relatively new with unknown long-term safety concerns.

我相信的原因是 - 首先，醫生 - 對不起 - 患者，大多數服用 Copaxone 的患者都很穩定，他們做得很好，我們看不到更換患者的理由對一個真正相對較新但存在未知的長期安全問題的產品做得很好。

And actually, if you talk about safety we have to look at the -- and on the safety as an issue that already well published and more that I think we have to pay attention to the potential long-term safety.

實際上，如果您談論安全性，我們必須將安全性視為一個已經發表的問題，而且我認為我們必須關注潛在的長期安全性。

And based on the experiences that we all have in the market, and physicians and patients, with Tysabri, we know there is a question of issues of safety in the short term and the emergence of safety issues on the long term.

根據我們所有人在市場上的經驗，以及醫生和患者對 Tysabri 的了解，我們知道存在短期安全問題和長期安全問題的出現。

So therefore I believe that physicians will, and definitely patients will follow, will prescribe the orals mainly in the third line therapy and, in some cases, in the second line therapy after a patient will fail -- have failed on one or two therapies.

因此，我相信醫生會，而且患者肯定會遵循，主要在三線治療中開口服藥，在某些情況下，在患者失敗後的二線治療中 - 對一種或兩種治療失敗。

I think it is fair to say that the oral might have the chance or the opportunity to expand the market as those patients that are really not -- or really currently not treated, (inaudible), or even former patients, that's an opportunity that the oral can offer to the market that will not come on the expense on the existing product, and definitely not the expense of Copaxone.

我認為可以公平地說，口服藥物可能有機會或有機會擴大市場，因為那些真正沒有——或目前確實沒有接受治療的患者，（聽不清），甚至是以前的患者，這是一個機會， oral 可以向市場提供不會以現有產品為代價的產品，而且絕對不是 Copaxone 的代價。

So therefore, if you look at the oral and we look at Copaxone, Copaxone can deliver, we are confident Copaxone will maintain its leadership and actually we will grow Copaxone sales in 2011.

因此，如果您看口服藥物，我們看 Copaxone，Copaxone 可以提供，我們相信 Copaxone 將保持其領先地位，實際上我們將在 2011 年增加 Copaxone 的銷售額。

That's helpful.

這很有幫助。

Thank you.

謝謝你。

Our next question comes from Gilbert Gregg (sic) with Bank of America.

我們的下一個問題來自美國銀行的 Gilbert Gregg（原文如此）。

Please state your question.

請說出你的問題。

Thanks.

謝謝。

Good morning.

早上好。

I think this one is for Bill on the 0.5 ml filing.

我想這個是給比爾的 0.5 毫升備案。

Regardless of whether you will get exclusivity or not, do you expect the product to have its own Orange Book entry?

不管您是否會獲得獨占權，您是否希望該產品有自己的橙皮書條目？

And separately, is there any intellectual property pending that is specific to that formulation?

另外，是否有任何特定於該配方的未決知識產權？

Gregg, good morning.

格雷格，早上好。

Should I call you Gregg or Gilbert?

我應該叫你格雷格還是吉爾伯特？

Your call.

你的來電。

I was kidding.

我是開玩笑的。

But in any case, it is impossible for us to say at this point in time really whether we will get the exclusivity on the sNDA, on the low volume.

但無論如何，我們不可能在這個時間點真正說出我們是否會獲得 sNDA 的獨家經營權。

I would like to believe that we should get that.

我想相信我們應該做到這一點。

But the fact of the matter is right now we will have to wait to see what the FDA's opinion is on this.

但事實是，現在我們將不得不等待，看看 FDA 對此有何看法。

Okay.

好的。

So whether or not it has its own Orange Book listing and exclusivity are tied to each other?

那麼它是否有自己的橙皮書上市和排他性是相互關聯的呢？

You don't know based on the type of application whether you would get an Orange Book listing that's separate or not?

您不知道根據應用程序的類型，您是否會獲得單獨的橙皮書列表？

I just want to make sure I am clear on this.

我只是想確保我清楚這一點。

It all depends on the label.

這一切都取決於標籤。

So at this point in time we are just not sure.

所以在這個時間點我們只是不確定。

Okay.

好的。

Fair enough.

很公平。

And then the other bigger picture North America question I have for you, Bill, is your latest thinking on the implementation or AMP, and the implications for your business and the industry.

Bill，我要問你的另一個北美大局問題是你對實施或 AMP 的最新想法，以及對你的業務和行業的影響。

Last time we checked in with you I think it was still unclear too what the final deadlines would be and what the effects might be.

上次我們與您聯繫時，我認為還不清楚最終截止日期是什麼以及可能產生的影響。

Well, we know that the effect actually, the Bill was signed on March 23rd, and then it actually goes into effect at the first of next year.

好吧，我們知道實際效果，該法案於 3 月 23 日簽署，然後它實際上在明年的第一天生效。

And it will go back and reference pricing from the fourth quarter of 2010.

它將返回並參考 2010 年第四季度的定價。

That's our estimates right now.

這是我們目前的估計。

The actual, what the effect of AMP will be in the US is really a very interesting question.

實際上，AMP在美國的效果如何，真的是一個很有意思的問題。

We just don't have a good sense for that.

我們對此沒有很好的感覺。

One has to speculate that if you're talking about AMP being a weighted average of pricing that's sold using a particular formulation, with some exclusions and exclusions, essentially those largest purchasers that are not mail order, being the large chains in the US, are likely to be those individuals that drive the AMP.

人們必須推測，如果您談論的 AMP 是使用特定配方銷售的加權平均定價，有一些排除和排除，基本上那些非郵購的最大購買者，即美國的大型連鎖店，是可能是那些驅動 AMP 的人。

So those largest chains, prices will be largely what makes up the weighted average AMP because if you aggregate maybe a CVS and a Walgreens and a Wal-Mart and a Rite Aid together, you have got to have what's largely the retail market in the US.

因此，那些最大的連鎖店，價格將主要是構成加權平均 AMP 的因素，因為如果你將 CVS 和 Walgreens 以及沃爾瑪和 Rite Aid 聚集在一起，你必須擁有主要是美國的零售市場.

So, if you think about that, you have to wonder about the new dynamics and why do these large chains want to drive down price where they did prior.

所以，如果你考慮到這一點，你就會想知道新的動態以及為什麼這些大型連鎖店想要壓低他們之前所做的價格。

Prior they always wanted to get advantage over the other chain.

在此之前，他們一直想獲得優於其他連鎖店的優勢。

Now, if you drive down price at one particular location, whether it be in whatever city you are located, whichever chain drives down price, there's effect against everyone.

現在，如果你在一個特定地點壓低價格，無論是在你所在的任何城市，無論哪個連鎖店壓低價格，都會對所有人產生影響。

So you don't get to capture that benefit.

所以你無法獲得這種好處。

So it is really a perverse incentive.

所以這確實是一種不正當的激勵。

This was something that when this whole theory of AMP was talked about in Washington, we fought against it because we didn't think it was proper, the proper incentive.

這就是當在華盛頓談論 AMP 的整個理論時，我們反對它，因為我們認為它不合適，不合適的激勵。

But we will see what happens.

但我們會看到會發生什麼。

It is very much an open question, and anyone's guess is probably valid at this point.

這是一個懸而未決的問題，此時任何人的猜測都可能是正確的。

Thanks, Bill.

謝謝，比爾。

Lastly on biosimilars, has there been any color to offer on regulatory or legal issues with your GCSF filing?

最後，關於生物仿製藥，您的 GCSF 備案是否有任何關於監管或法律問題的色彩？

And are you doing anything with EPO in the US?

您在美國與 EPO 有過合作嗎？

Well, our file so far on the GCSF is progressing.

好吧，到目前為止，我們關於 GCSF 的文件正在處理中。

I don't think we will have anything to add on EPO just yet but we may have something to talk about a little later, but nothing to talk about right now.

我認為我們目前不會對 EPO 有任何補充，但我們可能稍後會談一些事情，但現在沒有什麼可談的。

We are proceeding down the path as a BLA at this point in time.

目前，我們正在作為 BLA 繼續前進。

And not with the ABLA route.

而不是 ABLA 路線。

Again, why would you take the ABLA route, which is very uncertain as to how to go down that path now.

同樣，您為什麼要走 ABLA 路線，現在對於如何走這條路非常不確定。

And if you look at some of the legal characteristics of how this Bill will work, why would I reveal my whole process to the innovator so that they can decide what to sue me on.

如果你看看這個法案將如何運作的一些法律特徵，我為什麼要向創新者透露我的整個過程，以便他們可以決定以什麼為由起訴我。

It just doesn't make a whole lot of sense for us, it is just much simpler for us to go down the path of a BLA.

這對我們來說沒有多大意義，走 BLA 的道路對我們來說要簡單得多。

Thanks a lot.

非常感謝。

Our next question comes from David Buck with Buckingham Research.

我們的下一個問題來自白金漢研究中心的大衛·巴克。

Please state your question.

請說出你的問題。

Yes.

是的。

Thanks.

謝謝。

Just a couple of quick ones.

只是幾個快速的。

First, for Eyal, can you give a sense of Ratiopharm, how you think they have been reacting in terms of performance to the European price cut environment, and what the run rate of sales would be from Ratiopharm in 2010?

首先，對於 Eyal，您能否介紹一下 Ratiopharm，您認為他們在績效方面對歐洲降價環境的反應如何，以及 2010 年 Ratiopharm 的銷售運行率是多少？

Secondly, for Moshe, can you talk a little bit about, you mentioned clinical trials as your view that you think it is the gold standard for a bioequivalent form of Copaxone.

其次，對於 Moshe，你能談談嗎，你提到臨床試驗是你認為它是 Copaxone 生物等效形式的金標準的觀點。

How do you expect at this point to get your message across to the FDA?

在這一點上，您希望如何將您的信息傳達給 FDA？

Obviously the citizen petition route has been tried.

顯然，公民上訪途徑已經嘗試過了。

What's the next step we should be expecting in dialogue with the Agency?

我們應該期待與原子能機構對話的下一步是什麼？

And finally can you just talk about what the status is of Laquinimod, and what the filing target date would be for that.

最後，您能否談談 Laquinimod 的狀態，以及它的申請目標日期。

Regarding Ratiopharm, I think this is way too early for us to provide an educated answer.

關於 Ratiopharm，我認為現在提供有根據的答案還為時過早。

We will open the boxes once we complete the acquisition.

一旦我們完成收購，我們將打開盒子。

We will learn and we'll come back to you guys well informed and educated.

我們將學習，並會在消息靈通和受過良好教育的情況下回到你們身邊。

I don't anticipate any material changes.

我預計不會有任何重大變化。

It seems that that business has been running well, but, numbers will be provided on a timely basis.

看起來業務一直運行良好，但會及時提供數字。

It is a private company, as you know, much less information than when you acquire a publicly traded company.

如您所知，它是一家私人公司，信息比您收購一家上市公司時要少得多。

Still view it in the period before closing as a potential competitor.

在關閉之前的一段時間內仍然將其視為潛在競爭對手。

So the level of detailed information provided to us was naturally limited and we will study and report.

因此提供給我們的詳細信息水平自然是有限的，我們將研究和報告。

But as I said, we don't anticipate surprises, and things have been dealing -- from all we know they have been dealing well with the environment, in Germany and rest of Europe where they are selling.

但正如我所說，我們預計不會出現意外，而且事情一直在處理 - 據我們所知，他們一直在很好地處理環境問題，在德國和他們銷售的歐洲其他地區。

David, as far as Copaxone, based on what we just heard from Benzi, and our understanding of Copaxone and the (inaudible), we believe that we will continue our interactions, and we plan to do it with the FDA.

大衛，就 Copaxone 而言，根據我們剛剛從 Benzi 那裡聽到的消息，以及我們對 Copaxone 和（聽不清）的理解，我們相信我們將繼續我們的互動，我們計劃與 FDA 進行互動。

And actually demonstrate to them and convince -- we believe that we convince the FDA that in the case of Copaxone, it is unavoidable that any generic competitor will need to embark on clinical study and even on the preclinical activities, as well.

實際上向他們證明並說服——我們相信我們說服了 FDA，就 Copaxone 而言，任何仿製藥競爭者都不可避免地需要開展臨床研究，甚至開展臨床前活動。

As far as Laquinimod, as we reported, we have completed the -- of course the recruitment and the first study.

就 Laquinimod 而言，正如我們報導的那樣，我們已經完成了——當然是招募和第一項研究。

We will see the results of the first study in the first quarter of 2011 and followed by the result of the second study by the mid of 2011.

我們將在 2011 年第一季度看到第一項研究的結果，然後在 2011 年年中看到第二項研究的結果。

And followed by the result of the second study by the mid of 2011, and if everything goes as we plan, we immediately plan to submit the file as we have a fast track in the US, we are planning to launch the product by mid 2012.

然後是 2011 年年中第二次研究的結果，如果一切按計劃進行，我們立即計劃提交文件，因為我們在美國有快速通道，我們計劃在 2012 年年中推出產品.

Just one follow up.

只是一個跟進。

Would you anticipate any type of public forum such as an advisory committee, on Copaxone on the issues that you raised?

您是否希望就您提出的問題在 Copaxone 上召開任何類型的公共論壇，例如諮詢委員會？

That could be one of the scenarios that can take place.

這可能是可能發生的情況之一。

I think that the dialogue with the FDA is ongoing and we believe that based on the recent publication on the Copaxone and the mood effects, that this is the case that the FDA will require clinical studies from any follow on Copaxone.

我認為與 FDA 的對話正在進行中，我們相信，根據最近關於 Copaxone 和情緒影響的出版物，在這種情況下，FDA 將要求對任何後續的 Copaxone 進行臨床研究。

Thank you.

謝謝你。

Our next question comes from John Boris with Citi.

我們的下一個問題來自花旗的約翰鮑里斯。

Please state your question.

請說出你的問題。

Thanks for taking the question.

感謝您提出問題。

The first couple are for Eyal, and then I have a couple of follow ups for Bill.

第一對是 Eyal，然後我對 Bill 進行了幾次跟進。

First, on cost of goods, can you just help us understand what the impact of foreign exchange was on COGS within the quarter?

首先，關於商品成本，您能否幫助我們了解外匯對本季度 COGS 的影響？

And then you do provide us with your API sales.

然後您向我們提供您的 API 銷售。

Can you provide us with your global generic and branded sales within the quarter?

您能否向我們提供本季度內您的全球非專利藥和品牌藥的銷售額？

First of all, on COGS, there was major improvement in COGS that we have seen.

首先，在 COGS 上，我們已經看到 COGS 有了重大改進。

Mostly a matter of product mix, that we have seen.

我們已經看到，主要是產品組合問題。

What was the second question?

第二個問題是什麼？

You give us API, can you possible provide percent generic and percent branded sales?

你給我們 API，你能提供通用百分比和品牌銷售額百分比嗎？

The breakout, I don't have under my hand regarding API sales.

突破，我沒有掌握關於 API 銷售的信息。

We had a very strong and good quarter on the sales of API, actually, with growth of about 23% year over year.

實際上，我們在 API 的銷售方面有一個非常強勁和良好的季度，同比增長約 23%。

And, as you know, we stopped publishing this individually as a business unit around $163 million for the quarter, and 23% growth.

而且，如您所知，我們停止將此作為一個業務部門單獨發布，本季度約為 1.63 億美元，增長率為 23%。

Okay.

好的。

For Bill, can you just comment on whether you have launch quantities available on Lovenox and your capability of being able to supply the market.

對於 Bill，您能否評論一下您在 Lovenox 上是否有可用的啟動數量以及您能夠供應市場的能力。

Some initial checks would seem to indicate that Momenta, Sandoz might be somewhat capacity constrained.

一些初步檢查似乎表明 Momenta、Sandoz 的容量可能有些受限。

And then second question just has to do with the Office of Generic Drugs.

第二個問題與仿製藥辦公室有關。

Seems as though between some patch formulation getting approved, some high profile sustained relief preparations, and then the Lovenox approval, are we seeing a pick up at OGD or is this just an anomaly?

似乎在一些貼劑配方獲得批准、一些備受矚目的持續緩解準備，然後是 Lovenox 批准之間，我們是否看到 OGD 有所回升，或者這只是一個異常現象？

Thanks for the question, John.

謝謝你的問題，約翰。

As far as launch quantities with respect to enoxaparin, the answer is yes.

就依諾肝素的投放量而言，答案是肯定的。

We are in good shape.

我們的狀態很好。

We will need approval and of course we commented on that earlier.

我們需要獲得批准，當然我們早些時候對此發表了評論。

The second question, your second question was about the OGD and its activity now and the leadership there.

第二個問題，你的第二個問題是關於 OGD 及其現在的活動以及那裡的領導層。

I think on that particular question, I do see them getting bolder and making some very interesting calls.

我認為在那個特定問題上，我確實看到他們變得更加大膽並做出了一些非常有趣的決定。

And I think this is really a step in the right direction.

我認為這確實是朝著正確方向邁出的一步。

There's interim leadership right now in the department, and we take our hats off to them for approving enoxaparin and proving that they can stand some tough tests.

該部門現在有臨時領導，我們對他們批准依諾肝素並證明他們可以經受一些嚴峻考驗表示敬意。

So we think that that's really a positive thing at this point in time.

所以我們認為在這個時間點這真的是一件積極的事情。

Thank you.

謝謝你。

The next question is from Marc Goodman with UBS.

下一個問題來自瑞銀的馬克古德曼。

Please state your question.

請說出你的問題。

First, you keep talking about the US based business being strong.

首先，你一直在談論美國的業務很強大。

Can you just give us an indication of is this stronger than last quarter?

你能告訴我們這比上一季度強嗎？

Is last quarter stronger than fourth quarter?

上一季度是否強於四季度？

Is this getting better or is this just continues to be stable?

這是在好轉還是只是繼續保持穩定？

Maybe you can put some color around that.

也許你可以給它塗上一些顏色。

And then, also, Canada, obviously we have seen what Canada is going to do to pricing.

然後，還有加拿大，顯然我們已經看到了加拿大將對定價採取的措施。

Give us a flavor for how that's going to impact your business, the business you are about to get from Ratiopharm?

告訴我們這將如何影響您的業務，您將從 Ratiopharm 獲得的業務？

Should we be assuming that the Canadian sales are going to be down in 2011 versus 2010?

我們是否應該假設 2011 年加拿大的銷售額將低於 2010 年？

Bill?

賬單？

Yes, Marc.

是的，馬克。

A couple of points here.

這裡有幾點。

The base business is strong.

基地業務實力雄厚。

We have done a lot of things to improve our base over the last couple of years, whether it is pruning where we have taken out some of the less profitable products and sell more of the profitable products.

在過去的幾年裡，我們做了很多事情來改善我們的基礎，無論是修剪我們已經取出一些利潤較低的產品並銷售更多利潤產品的地方。

We have seen more impact around price increases.

我們已經看到價格上漲帶來的更多影響。

Just lots and lots of different things.

只是很多很多不同的東西。

Some of the products that have launched have launched a little better pricing than it had historically.

一些已經推出的產品推出了比歷史上更好的定價。

Some of this can be retraced to the quality concerns.

其中一些可以追溯到質量問題。

Lots of proactive things going on in our base business.

我們的基礎業務中發生了許多積極主動的事情。

So I think that by and large our base business has been strong for the last few quarters, and continues to be strong.

因此，我認為總的來說，我們的基礎業務在過去幾個季度表現強勁，並將繼續保持強勁勢頭。

There's not much more to say about it than that.

沒有比這更多的話要說了。

When you say is that changing from quarter to quarter, remember, the way we track our base business, it's products that have been in the market for two years.

當你說每個季度都在變化時，請記住，我們跟踪基礎業務的方式是已經上市兩年的產品。

So every quarter and old launch product becomes a base product, and of course that changes your numbers somewhat.

所以每個季度和舊的發布產品都會成為基礎產品，當然這會稍微改變你的數字。

But it has been a very strong business.

但它一直是一個非常強大的業務。

As far as Canada goes, the Canadian business we continue to believe is going to be strong.

就加拿大而言，我們仍然相信加拿大的業務將會很強大。

Obviously the effect in the various provinces of the change, especially with respect to Ontario, that's going to have an effect.

顯然，變化對各個省份的影響，尤其是在安大略省，將會產生影響。

The idea though is, the big change is what happens with the chain or the pharmacy itself.

不過，想法是，最大的變化是連鎖店或藥房本身發生的變化。

In that particular system, where they are lowering the reference price, it is not indifferent, by the way, to what is happening in other markets, whether you see the US change in AMP or you see the change in Spain.

在那個特定的系統中，他們正在降低參考價格，順便說一下，它對其他市場正在發生的事情並不無動於衷，無論你看到美國 AMP 的變化還是你看到西班牙的變化。

It is really the government trying to take something out of the channel.

這真的是政府試圖從渠道中拿走一些東西。

And what they're doing is lowering price and then you're limiting your back end to the pharmacies themselves.

他們所做的是降低價格，然後你將後端限制在藥店本身。

So net-net for us, it's not as huge of a change as one might expect.

所以對我們來說，net-net 並沒有人們預期的那麼大的變化。

We certainly believe we will get some pressure from the chains in orders to get more on the back end.

我們當然相信我們會從連鎖店那裡承受一些壓力，以便在後端獲得更多。

But at this point in time we don't see a huge change.

但目前我們還沒有看到巨大的變化。

It may actually be a net positive for the business, as it becomes more difficult for some of the smaller companies to manage.

這實際上對企業來說可能是一個淨積極因素，因為對於一些較小的公司來說，管理起來變得更加困難。

So we should be assuming Canadian sales in 2011 will be up from 2010?

那麼我們應該假設 2011 年加拿大的銷售額將高於 2010 年？

Obviously with the addition of Ratiopharm.

很明顯，添加了 Ratiopharm。

And again, I can't really comment on that until I actually get my hands on the Ratio business, and I am able to look at it.

再一次，在我真正接觸到 Ratio 業務之前，我無法對此發表評論，並且我能夠看到它。

Just on your own base business in Canada you would expect it to be up next year?

就您自己在加拿大的基礎業務而言，您會期望它明年會好起來嗎？

Our business has been growing and will continue to grow.

我們的業務一直在增長，並將繼續增長。

Let me take this opportunity to follow on because I see that the pricing pressure is a kind of common denominator question, all over the globe.

讓我藉此機會繼續討論，因為我看到定價壓力是全球範圍內的一種共同問題。

I think that the results in Europe, 10% growth is actually the best answer to prove the statement that Teva knows how to operate in a price pressure environment.

我認為歐洲的結果，10% 的增長實際上是證明 Teva 知道如何在價格壓力環境中運作的聲明的最佳答案。

This is not just a statement for stating the obvious from our point of view.

這不僅僅是從我們的角度陳述顯而易見的陳述。

It's just to say that we know how to leverage our market leadership, how to leverage our skills, and how to leverage our largest ever portfolio and our different lines of business.

這只是說我們知道如何利用我們的市場領導地位，如何利用我們的技能，以及如何利用我們有史以來最大的投資組合和我們不同的業務線。

And if you add to that the deep understanding and the know how in different models of businesses, countries and healthcare system, that actually give you the answer of how we are managing to continue a profitable journey in a pressurized environment exactly as we did it for many years in the United States.

如果你再加上對不同商業模式、國家和醫療保健系統的深刻理解和專業知識，那實際上會給你答案，告訴你我們如何在壓力環境中繼續盈利之旅，就像我們過去所做的那樣在美國多年。

So, we believe that this is one of our unique advantages that make us different from part of our peers, that we know how to operate and how to make money, and even how, of course, to grow the business under this different business or market environment.

所以，我們認為，這是我們與眾不同的獨特優勢之一，我們知道如何經營，如何賺錢，甚至知道如何在這種不同的業務下發展業務或市場環境。

Thank you.

謝謝你。

Your next question comes from Corey Davis with Jefferies & Company.

您的下一個問題來自 Jefferies & Company 的 Corey Davis。

Please state your question.

請說出你的問題。

Let me just follow on, then, to that last comment you just made.

那麼，讓我繼續談談你剛剛發表的最後一條評論。

So, if you're continuing to grow in the face of pricing pressure, I guess the only way to do that would be to gain share.

所以，如果你在面對定價壓力的情況下繼續增長，我想唯一的方法就是獲得市場份額。

So, A, do you agree with that?

那麼，A，你同意嗎？

And, B, since you are the first of the big public companies to report, when the others report, are we going to see perhaps less robust results?

而且，B，因為你是第一家發布報告的大型上市公司，當其他公司報告時，我們是否會看到可能不太強勁的結果？

I am not asking you to comment specifically on their results but if you are gaining share in volume terms you have to be gaining it from other players.

我並不是要你專門評論他們的結果，但如果你在數量上獲得份額，你必須從其他玩家那裡獲得。

So is that the right way to think of how you're being so successful in Europe in the face of such pricing pressure?

那麼，面對這樣的定價壓力，這是思考您如何在歐洲如此成功的正確方法嗎？

First of all, as a general statement, I would agree with you, that market leadership is about getting market share.

首先，作為一般性陳述，我同意你的觀點，市場領導地位就是獲得市場份額。

We said it many times in the past, that our strategy is to gain more market share.

我們過去多次說過，我們的戰略是獲得更多的市場份額。

There's only one caveat to your way of posing the question.

您提出問題的方式只有一個警告。

I do believe that in certain markets, definitely Europe is a good geography for that, that we can also see larger pie.

我確實相信在某些市場，歐洲絕對是一個很好的地理位置，我們也可以看到更大的蛋糕。

So actually see more market, or potential market, as the European markets, at least some of them, the level of the generic penetration is relatively low compared to a market like US or let's call it generic developed countries in Europe.

因此，實際上看到更多的市場或潛在市場，如歐洲市場，至少其中一些市場，與美國這樣的市場相比，仿製藥的滲透水平相對較低，或者我們稱之為歐洲的仿製藥發達國家。

So there's still more room to grow generics and therefore we are so optimistic on the business in Europe, not only by taking market share for our competitors but also by growing the overall market for generics in Europe and some other countries in the world, as well.

所以仿製藥還有更大的增長空間，因此我們對歐洲的業務非常樂觀，不僅要為我們的競爭對手搶占市場份額，還要擴大歐洲和世界其他一些國家仿製藥的整體市場，以及.

For Eyal, did I hear you say that the goal is to take your tax rate down to 12% in 2012?

對於 Eyal，我是否聽說過您的目標是在 2012 年將您的稅率降至 12%？

No, no, no.

不不不。

I don't recall saying anything of that kind.

我不記得說過那樣的話。

I must have misheard.

我一定是聽錯了。

In my opening comments I said that our GAAP tax rate for this year is estimated at 12%, at 15% on a non-GAAP basis, and we don't see this declining in 2012.

在我的開場評論中，我說我們今年的 GAAP 稅率估計為 12%，在非 GAAP 基礎上為 15%，我們認為 2012 年不會下降。

Okay.

好的。

Got that.

了解。

And for Bill, I think I got the message, but I sensed fairly extreme optimism on your own generic Lovenox.

對於 Bill，我想我明白了，但我對你們自己的仿製 Lovenox 感到非常樂觀。

Can you elaborate even more on your interactions with the FDA discussions?

您能否詳細說明您與 FDA 討論的互動？

Is it really nothing more than checking all of the boxes that they put out in their response to the CP, and just finishing up their review of your immunogenicity data you mentioned?

真的只是檢查他們在對 CP 的回應中提出的所有方框，並完成他們對你提到的免疫原性數據的審查嗎？

Corey, it is hard for me to say much more.

科里，我很難說更多。

We have dialogue with the Agency.

我們與原子能機構進行了對話。

We believe we have, first of all, we have looked at the citizens' petition.

我們相信，首先，我們已經看過市民的請願書。

We believe we meet all the criteria on the citizens; petition.

我們相信我們符合公民的所有標準；請願。

Our dialogue with the Agency says that our review is going nicely, and we are just waiting for an answer.

我們與原子能機構的對話表明我們的審查進展順利，我們只是在等待答复。

So, we feel we are in a good position but again it is up to the FDA to decide, not me.

所以，我們覺得我們處於有利地位，但再次由 FDA 決定，而不是我。

Right.

正確的。

And last one, Eyal, can you just run down the list of countries in Europe or broadly when the royalty rates flip from the rough 50% on Copaxone down to the 6% as we go through 2012?

最後一個，Eyal，當我們經歷 2012 年時，當 Copaxone 的特許權使用費率從大約 50% 下降到 6% 時，您能否列出歐洲或更廣泛的國家？

Let me take this off line.

讓我把這個脫機。

We want to be precise, we should have the list in front of us.

我們想要精確，我們應該把清單擺在我們面前。

Let's take this off line.

讓我們把它脫機。

Fair enough.

很公平。

Thanks.

謝謝。

Just one more, just before the next question, just one more follow on the Copaxone, as it is becomes the major subject in this conference call.

再問一個問題，就在下一個問題之前，再問一個關於 Copaxone 的問題，因為它已成為本次電話會議的主要主題。

To add on comments to add to what we all answered in this respect.

添加評論以添加我們在這方面的所有回答。

One is just to remind you that about a third of our Copaxone sales is in non US markets, which the whole discussion that we are involved in is less relevant for this $1 billion growing business.

一個只是提醒您，我們大約三分之一的 Copaxone 銷售額在非美國市場，我們參與的整個討論與這個 10 億美元的增長業務不太相關。

The second comment is regarding the oral therapies.

第二條意見是關於口服療法。

As a kind of fruitful thought I would like to take the case study for you and you can look at it what respective, which reminds me to be the next oral therapies and you see the current market share and developing the last six years, it can give you a good hunch on where we see this oral is going to be in the coming years.

作為一種富有成效的想法，我想為您進行案例研究，您可以看看它分別是什麼，這讓我想起了下一個口服療法，您可以看到當前的市場份額和過去六年的發展，它可以給你一個很好的預感，我們會在未來幾年看到這個口頭的地方。

Thank you.

謝謝你。

Our final question comes from [Mylan Paratay] with Credit Agricole.

我們的最後一個問題來自法國農業信貸銀行的 [Mylan Paratay]。

Please state your question.

請說出你的問題。

It is David Maris.

是大衛·馬里斯。

On Copaxone, can you just update us again on the timing of the trial and the decision and walk us through your timing assumptions?

關於 Copaxone，您能否再次向我們更新試驗時間和決定，並向我們介紹您的時間假設？

You mentioned it earlier?

你之前提到過？

Which trial?

哪個審判？

The Copaxone trial.

Copaxone 試驗。

Are you referring to GALA trial?

你指的是 GALA 試驗嗎？

No, no, the legal trial.

不，不，法律審判。

I will take that one.

我會拿那個。

Right now, David, as you know, we are waiting for our claims construction.

現在，大衛，如你所知，我們正在等待我們的索賠結構。

There's no trial date set.

沒有設置試用日期。

And whether the claims construction, whether the Mylan Natco data gets rolled into that claim construction, it is very difficult to say at this point in time.

以及索賠結構，Mylan Natco 數據是否被納入索賠結構，目前很難說。

Judge Jones is a fairly busy judge, and so we will have to wait and see.

瓊斯法官是一位相當忙碌的法官，所以我們將不得不拭目以待。

We just don't know the timing of the claims construction.

我們只是不知道索賠結構的時間。

Once we get that, of course, then we can get on to scheduling and trial and so on and so forth.

當然，一旦我們明白了，我們就可以開始安排和試驗等等。

Bill, based on your best guesstimate, would you assume it starts in the fall or early winter?

比爾，根據你最好的猜測，你認為它會在秋天或初冬開始嗎？

Gets resolved sometime mid year next year?

明年年中某個時候解決？

No, no.

不，不。

I think that's very optimistic, I would say much farther out than that.

我認為這是非常樂觀的，我想說的遠不止於此。

Great.

偉大的。

Thank you very much.

非常感謝。

Thank you all very much for joining us today.

非常感謝大家今天加入我們。

As you have heard, we had a great quarter, and we are very enthusiastic about the rest of 2010.

如您所知，我們度過了一個美好的季度，我們對 2010 年餘下的時間充滿熱情。

So, thank you again and you have a good day.

所以，再次感謝你，祝你有美好的一天。

Thank you.

謝謝你。

This concludes today's teleconference.

今天的電話會議到此結束。

You may disconnect your lines at this time.

此時您可以斷開線路。

Thank you all for your participation.

謝謝大家的參與。