Teva Pharmaceutical Industries Ltd (TEVA) 2012 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Welcome to the third quarter 2012 Teva Pharmaceutical Industries Ltd earnings conference call.

    歡迎來到梯瓦製藥工業有限公司 2012 年第三季度財報電話會議。

  • My name is Larissa and I'll be your operator for today's call.

    我叫拉里薩,我將擔任今天電話的接線員。

  • 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。

  • Later, we'll conduct a question-and-answer session.

    稍後,我們將進行問答環節。

  • Please note that this conference is being recorded.

    請注意,此會議正在錄製中。

  • I'd now like to turn the call over to Mr. Kevin Mannix.

    我現在想把電話轉給 Kevin Mannix 先生。

  • Mr. Mannix, you may begin.

    Mannix 先生,您可以開始了。

  • - IR, Teva North America

    - IR, Teva North America

  • Thank you and good morning.

    謝謝你,早上好。

  • Good afternoon everyone.

    大家下午好。

  • I'm joined today by our President and CEO, Dr. Jeremy Levin, our CFO, Eyal Desheh, and additional members of the Teva executive team.

    今天,我們的總裁兼首席執行官 Jeremy Levin 博士、我們的首席財務官 Eyal Desheh 以及 Teva 執行團隊的其他成員也加入了我的行列。

  • Jeremy will begin by providing an overview of the quarter's highlights followed by Eyal who will then provide additional details on our consolidated financial results.

    Jeremy 將首先概述本季度的亮點,然後 Eyal 將提供有關我們綜合財務業績的更多詳細信息。

  • 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 start I'd like to remind you that our discussions during this conference call will include forward-looking statements.

    在我們開始之前,我想提醒您,我們在本次電話會議期間的討論將包括前瞻性陳述。

  • Actual results could differ materially from those projected in the forward-looking statements as a result of foreign currency translation effects, macroeconomic trends, interruptions in our supply chain, and other factors that could cause actual results to differ as discussed in Teva's report on Form 20-F and Form 6-K.

    由於外幣換算效應、宏觀經濟趨勢、我們供應鏈的中斷以及其他可能導致實際結果與 Teva 表 20 報告中討論的不同的因素,實際結果可能與前瞻性陳述中預測的結果存在重大差異-F 和表格 6-K。

  • Also, we are presenting non-GAAP data which excludes the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step up, legal settlements, and reserves and impairment, and related tax effects.

    此外,我們提供的非 GAAP 數據不包括已購無形資產的攤銷、與某些監管行動相關的成本、庫存增加、法律結算、準備金和減值以及相關的稅收影響。

  • With that I will now turn the call over to Jeremy.

    有了這個,我現在將把電話轉給傑里米。

  • Jeremy, if you would, please.

    傑里米,如果你願意的話,請。

  • - President and CEO

    - President and CEO

  • Thank you, Kevin.

    謝謝你,凱文。

  • Good morning everyone.

    大家,早安。

  • And thank you for joining the call today to discuss Teva's third quarter 2012 results.

    感謝您參加今天的電話會議,討論 Teva 2012 年第三季度的業績。

  • Before I begin, I'd like to thank those of you who have joined us from New York and the East Coast, despite the tremendous problems I know some of you are experiencing.

    在開始之前,我要感謝從紐約和東海岸加入我們的各位,儘管我知道你們中的一些人正在經歷巨大的問題。

  • We really appreciate your commitment and interest and hope that you and your families are safe.

    我們非常感謝您的承諾和興趣,並希望您和您的家人安全。

  • During my remarks this morning, I will briefly discuss the quarterly results and then provide some content around the initial steps we are undertaking to reshape our Company.

    在今天上午的發言中,我將簡要討論季度業績,然後圍繞我們為重塑公司而採取的初步步驟提供一些內容。

  • As I promised shareholders on the May 24th call, as CEO of this Company I will ensure that we are managed and will continue to manage all of our businesses in a disciplined and focused manner.

    正如我在 5 月 24 日的電話會議上向股東承諾的那樣,作為該公司的首席執行官,我將確保我們得到管理,並將繼續以紀律嚴明和專注的方式管理我們所有的業務。

  • This quarter's results and the way we are managing the business now reflects this approach.

    本季度的業績和我們現在管理業務的方式反映了這種方法。

  • I'll start with a few comments about the quarter.

    我將從關於本季度的一些評論開始。

  • Overall, we had a solid performance.

    總的來說,我們的表現很不錯。

  • We ended the quarter with top line net revenue growth of 14%, compared to the third quarter of 2011.

    與 2011 年第三季度相比,我們在本季度末的淨收入增長了 14%。

  • And non-GAAP EPS coming in at $1.28 per share.

    非 GAAP 每股收益為 1.28 美元。

  • The quarter's GAAP results were primarily offset by a decision to account for a $670 million provision for a possible future loss and damage payment for the pantoprazole litigation.

    該季度的 GAAP 業績主要被決定為泮托拉唑訴訟的未來可能損失和損害賠償計入 6.7 億美元準備金的決定所抵消。

  • In addition, we're recognizing an impairment charge of $481 million, with the majority of these charges reflecting pipeline products that the Company acquired through its acquisition of Cephalon.

    此外,我們確認了 4.81 億美元的減值費用,其中大部分費用反映了公司通過收購 Cephalon 獲得的管道產品。

  • Our year-to-date GAAP EPS decreased 25% compared to the same period in 2011.

    與 2011 年同期相比,我們年初至今的 GAAP 每股收益下降了 25%。

  • This decrease was driven by the same reasons.

    這種減少也是出於同樣的原因。

  • While these legacy events have an unfortunate impact on our current results, we remain on track to reach our financial goals for the year.

    儘管這些遺留事件對我們當前的業績產生了不幸的影響,但我們仍有望實現今年的財務目標。

  • We now anticipate 2012 sales to be between $20.1 billion and $20.7 billion, and non-GAAP earnings per share of between $5.32 and $5.38.

    我們現在預計 2012 年銷售額在 201 億美元至 207 億美元之間,非 GAAP 每股收益在 5.32 美元至 5.38 美元之間。

  • Eyal will take you through the details of the financials later in the call.

    Eyal 將在稍後的電話會議中向您詳細介紹財務狀況。

  • I'll now take a few moments to discuss Copaxone and laquinimod.

    我現在花點時間討論 Copaxone 和 laquinimod。

  • Copaxone continues to lead the US in global relapsing remitting multiple sclerosis market in both sales and market share.

    Copaxone 在全球復發緩解型多發性硬化症市場的銷售額和市場份額方面繼續領先美國。

  • Copaxone remains above 40% of market share in the US and we anticipate it will maintain its global market leadership position due to its established and clinical experience in treating RRMS patients.

    Copaxone 在美國的市場份額仍保持在 40% 以上,我們預計,由於其在治療 RRMS 患者方面的既定臨床經驗,它將保持其全球市場領導地位。

  • We continue to consider and develop ways to enhance patient experience with Copaxone through a very vigorous life cycle management program.

    我們繼續考慮和開發方法,通過非常有力的生命週期管理計劃來增強患者對 Copaxone 的體驗。

  • In that respect, we were particularly pleased to present the Phase III GALA study as late breaking research at the ECTRIMS Congress in October.

    在這方面,我們特別高興地在 10 月的 ECTRIMS 大會上將 III 期 GALA 研究作為最新突破性研究進行介紹。

  • The results showed that three times weekly dosing of glatiramer acetate 40 milligrams per mill significantly reduced an annualized relapse rate in RRMS patients while maintaining a favorable safety and tolerability profile.

    結果表明,每週 3 次醋酸格拉替雷 40 毫克/毫升的給藥顯著降低了 RRMS 患者的年化復發率,同時保持了良好的安全性和耐受性。

  • We are very pleased with the possibility of providing an alternative therapeutic option for patients with RRMS without compromising efficacy or safety.

    我們很高興有可能在不影響療效或安全性的情況下為 RRMS 患者提供替代治療選擇。

  • We see real potential for laquinimod and are committed to its ongoing research and development.

    我們看到了 laquinimod 的真正潛力,並致力於其持續的研究和開發。

  • Our efforts initially focused on oral laquinimod as a potential RRMS therapy.

    我們的努力最初集中在口服拉喹莫德作為一種潛在的 RRMS 療法。

  • In this area, after reaching agreement with the US Food and Drug Administration on a Special Protocol Assessment, we're in the process of initiating a third Phase III study of laquinimod called CONCERTO which will evaluate the impact of laquinimod on disability progression as a primary end point in patients with RRMS.

    在這一領域,在與美國食品和藥物管理局就一項特殊協議評估達成協議後,我們正在啟動名為 CONCERTO 的拉喹莫德的第三階段 III 期研究,該研究將評估拉喹莫德對殘疾進展的影響,作為主要療法RRMS 患者的終點。

  • We submitted the Noventro file to the European Medicines Agency and are preparing to launch this product across Europe.

    我們向歐洲藥品管理局提交了 Noventro 文件,並準備在整個歐洲推出該產品。

  • This will broaden our commitment to the MS community and patients around the world.

    這將擴大我們對全球 MS 社區和患者的承諾。

  • Further, we're encouraged by the Phase II A laquinimod data in patients with moderate to severe Crohn's disease versus placebo which was presented as an oral presentation at the 20th European Gastroenterology Week Conference in October.

    此外,在 10 月的第 20 屆歐洲胃腸病學週會議上以口頭報告的形式在中度至重度克羅恩病患者中對比安慰劑的 II A 期拉喹莫德數據令我們感到鼓舞。

  • The data is consistent with what we believe to be a safe and effective compound that has several important potential uses and provides us with a rational to further investigate the potential benefits of laquinimod in Crohn's disease.

    該數據與我們認為是一種安全有效的化合物一致,該化合物具有多種重要的潛在用途,並為我們提供了進一步研究拉喹莫德在克羅恩病中的潛在益處的理由。

  • Now turning to our generics business.

    現在轉向我們的仿製藥業務。

  • We successfully launched nine new products in the US market during the quarter, representing over $8 billion of brand value.

    本季度,我們在美國市場成功推出了九款新產品,品牌價值超過 80 億美元。

  • This brings the total number of new products launched in the US to date this year to 20 products, representing approximately $23 billion of brand value.

    這使今年迄今為止在美國推出的新產品總數達到 20 種,品牌價值約為 230 億美元。

  • We are excited to have the opportunity to launch several additional products in the fourth quarter in what we expect to be one of the busiest years on record for our US generics business.

    我們很高興有機會在第四季度推出其他幾款產品,我們預計這將是我們美國仿製藥業務有記錄以來最繁忙的年份之一。

  • Regarding our European business, we increased sales of 1% in dollar terms and by 13% in local currency terms.

    關於我們的歐洲業務,我們的銷售額以美元計算增長了 1%,以當地貨幣計算增長了 13%。

  • Additionally, we're taking a selective approach to the generic tender market, managing costs and are focused on sustainable business opportunity.

    此外,我們正在對通用招標市場採取選擇性方法,管理成本並專注於可持續的商業機會。

  • This is in line with our strategy for European generics business, to focus on profitability and sustainable, profitable growth.

    這符合我們針對歐洲仿製藥業務的戰略,即專注於盈利能力和可持續的盈利增長。

  • We've been tightly managing our resources and commercial organizations across the region to increase our profitability while maintaining our leadership position.

    我們一直嚴格管理我們在該地區的資源和商業組織,以提高我們的盈利能力,同時保持我們的領先地位。

  • I'd like to mention that in October we successfully resolved the warning letter that was received from the US FDA for the Irvine manufacturing facility in 2009.

    我想提一下,我們在 10 月份成功解決了 2009 年從美國 FDA 收到的爾灣製造工廠的警告信。

  • A number of steps were taken to rectify the situation, including upgrades to the building and systems, as well as manufacturing and quality processes and practices.

    採取了一系列措施來糾正這種情況,包括升級建築和系統,以及製造和質量流程和實踐。

  • At this facility, we continue to focus first and foremost on those life saving therapies on the drug shortage list and you'll be hearing more about our manufacturing efforts during our Investor Day.

    在這個工廠,我們繼續首先關注藥物短缺清單上的那些挽救生命的療法,您將在我們的投資者日期間聽到更多關於我們製造工作的信息。

  • PGT Healthcare, the joint venture between P&G and (inaudible) and Teva celebrates its one year anniversary on November 1. The JV is progressing as planned, leveraging the core technology and go-to-market strength of Teva and the consumer understanding and branding strength of P&G.

    PGT Healthcare 是寶潔與(聽不清)和 Teva 的合資企業,將於 11 月 1 日慶祝成立一周年。該合資企業正在按計劃進行,利用 Teva 的核心技術和上市實力以及消費者理解和品牌實力寶潔公司。

  • The combined strengths of Teva and P&G are enabling us to accelerate our rate of global expansion and category growth.

    Teva 和 P&G 的綜合實力使我們能夠加快全球擴張和品類增長的速度。

  • The OTC business is strategically important to us.

    場外交易業務對我們具有重要的戰略意義。

  • Given global trends and demographies, we think this is a growth engine for the Company now and into the future and we see the PGT joint venture as a key enabler.

    鑑於全球趨勢和人口統計,我們認為這是公司現在和未來的增長引擎,我們將 PGT 合資企業視為關鍵推動因素。

  • I'd now like to take a moment to discuss some important steps that have taken place over the last few months and which are part of the Company's overall strategy.

    我現在想花點時間討論過去幾個月中採取的一些重要步驟,這些步驟是公司整體戰略的一部分。

  • We've undertaken several steps to create a foundation for reshaping our Company.

    我們已經採取了幾個步驟來為重塑我們的公司奠定基礎。

  • This of course includes the ongoing process to build a world class management team.

    這當然包括建立世界級管理團隊的持續過程。

  • We appointed Dr. Jonathan Isaacson to the newly created position of Chief Medical Officer, and Professor Itzhak Krinsky as Chairman of Teva Japan and Teva South Korea and Head of Business Development, Asia-Pacific.

    我們任命 Jonathan Isaacson 博士擔任新設立的首席醫療官一職,並任命 Itzhak Krinsky 教授擔任 Teva 日本和 Teva 韓國董事長以及亞太區業務發展主管。

  • In addition, in this reshaping process we identified key assets in the R&D program, and as part of our commitment to organic growth, we will increase our focus in areas such as CNS and respiratory.

    此外,在這個重塑過程中,我們確定了研發計劃中的關鍵資產,作為我們對有機增長承諾的一部分,我們將增加對中樞神經系統和呼吸系統等領域的關注。

  • We believe a focused pipeline is essential to our Company's future success and are committed to investing our resources in the right programs, in the right markets and at the right times.

    我們相信,集中的管道對我們公司未來的成功至關重要,並致力於在正確的時間、正確的市場中將我們的資源投資於正確的項目。

  • In order to do this, we will manage our R&D cost and expenses in a disciplined manner, while using the talent within our organization to build a culture that is committed to delivering profitable growth.

    為此,我們將以嚴謹的方式管理我們的研發成本和開支,同時利用我們組織內的人才來建立一種致力於實現盈利增長的文化。

  • Dr. Hayden, a world leading expert in Huntington's disease and his team identified and acquired Huntexil.

    世界領先的亨廷頓舞蹈症專家海登博士及其團隊發現並收購了 Huntexil。

  • This drug candidate is being developed for the symptomatic treatment of Huntington's disease, success in this area will be highly beneficial to patients and provide expansion to our CNS portfolio.

    該候選藥物正在開髮用於對症治療亨廷頓舞蹈病,在該領域的成功將對患者非常有益,並擴大我們的 CNS 產品組合。

  • The acquisition of Huntexil is one of examples of our strategy to build a robust pipeline through combining a vigorous approach to managing internal programs with a targeted selection and acquisition of external opportunities.

    收購 Huntexil 是我們通過將管理內部計劃的有力方法與有針對性地選擇和收購外部機會相結合來建立強大管道的戰略的一個例子。

  • As part of our overall strategies to reshape Teva, we'll continue to leverage our product portfolio and R&D efforts while selling or out-licensing assets that no longer fit within the scope of our business.

    作為我們重塑 Teva 的總體戰略的一部分,我們將繼續利用我們的產品組合和研發工作,同時出售或向外許可不再適合我們業務範圍的資產。

  • The sale of Teva's Animal Health unit reflects our commitment to focus our business on our core strengths, while divesting non-core assets to fund future growth.

    出售 Teva 的動物保健部門反映了我們致力於將我們的業務集中在我們的核心優勢上,同時剝離非核心資產以為未來增長提供資金。

  • These types of transactions are a key part of our strategy to reshape the Company through organic as well as inorganic growth.

    這些類型的交易是我們通過有機和無機增長重塑公司戰略的關鍵部分。

  • I will closely oversee our activities in this area and, therefore, I assigned the responsibility of corporate business development as part of the office of the CEO.

    我將密切監督我們在這一領域的活動,因此,我將公司業務發展的職責分配給首席執行官辦公室。

  • You'll hear more about our approach in this arena on Investor Day.

    您將在投資者日聽到更多關於我們在這個領域的方法的信息。

  • I'll now turn the call over to Eyal.

    我現在將電話轉給 Eyal。

  • - CFO

    - CFO

  • Thank you, Jeremy and good morning everyone.

    謝謝你,傑里米,大家早上好。

  • We're pleased to share with you today our financial results for the third quarter of 2012.

    今天,我們很高興與您分享我們 2012 年第三季度的財務業績。

  • As we continue to get ready to embark on a new and exciting strategy for our Company, we're reporting today another solid quarter for Teva.

    隨著我們繼續準備為我們的公司實施一項令人興奮的新戰略,我們今天報告了 Teva 的另一個穩定季度。

  • Compared with Q3 2011, our net revenues grew by 14% or 19% in local currency and non-GAAP operating income and non-GAAP earnings per share grew by 6% and 2% respectively.

    與 2011 年第三季度相比,我們的淨收入以當地貨幣計算增長了 14% 或 19%,非 GAAP 營業收入和非 GAAP 每股收益分別增長了 6% 和 2%。

  • We also posted solid cash flow from operations and free cash flow.

    我們還公佈了穩定的運營現金流和自由現金流。

  • Many of our businesses performed well in this quarter.

    我們的許多業務在本季度表現良好。

  • Our global branded business, which was the main driver of growth, grew by 38% as we benefited from contributions from strong sales of Copaxone this quarter at over $1 billion, and from the Cephalon products.

    我們的全球品牌業務是增長的主要驅動力,增長了 38%,這得益於本季度 Copaxone 超過 10 億美元的強勁銷售額以及 Cephalon 產品的貢獻。

  • The US generic business continued its positive trend, increasing sales by 24%, compared to the third quarter of 2011, and benefiting from nine new launches in the quarter and a total of 20 launches so far this year.

    美國仿製藥業務延續其積極趨勢,與 2011 年第三季度相比銷售額增長 24%,受益於本季度九個新上市以及今年迄今共有 20 個上市。

  • Our businesses in Eastern Europe, Asia, and Latin America demonstrated organic and profitable growth.

    我們在東歐、亞洲和拉丁美洲的業務實現了有機增長和盈利增長。

  • We continue to strengthen and grow our OTC business together with our partner, Procter & Gamble.

    我們繼續與我們的合作夥伴寶潔公司一起加強和發展我們的場外交易業務。

  • We sold our Animal Health business with closing expected within a few months, and acquired a new branded asset for treatment of Huntington's disease.

    我們出售了我們的動物保健業務,預計將在幾個月內完成交易,並收購了一項用於治療亨廷頓舞蹈症的新品牌資產。

  • In Europe, we posted a year over year growth of 1% or 13% in local currency terms, mainly driven by the inclusion of Cephalon that contributed to our branded business and the take-back of Copaxone distribution rights.

    在歐洲,我們以當地貨幣計算同比增長 1% 或 13%,這主要是由於納入了為我們的品牌業務做出貢獻的 Cephalon 以及收回了 Copaxone 分銷權。

  • I would like to touch on two topics before I review the third quarter numbers in greater detail.

    在更詳細地回顧第三季度的數據之前,我想談兩個話題。

  • First, this quarter we made relatively high non-GAAP adjustments of $1.2 billion.

    首先,本季度我們進行了 12 億美元的相對較高的非 GAAP 調整。

  • This primarily consisted of a provision for loss contingency of $670 million related to the pantoprazole patent infringement litigation.

    這主要包括與泮托拉唑專利侵權訴訟相關的 6.7 億美元或有損失準備金。

  • The provision was triggered following a decision by federal circuit in an unrelated case which affected our estimate of the probable damages.

    該條款是在聯邦巡迴法院對一個不相關的案件做出決定後觸發的,該案件影響了我們對可能損害的估計。

  • A trial on these damages is scheduled to begin in June 2013, after which both the initial liability ruling and any damages awarded will be eligible for appeal.

    對這些損害賠償的審判定於 2013 年 6 月開始,之後,初始責任裁定和裁定的任何損害賠償均有資格上訴。

  • As we have long stated in our SEC filing, Teva has an insurance policy that specifically covers damages that may be awarded against us for patent infringement in this litigation, and we have every expectation that this policy will apply to this matter and provide partial coverage in case of damages.

    正如我們在提交給美國證券交易委員會的文件中長期聲明的那樣,Teva 有一份保險單專門涵蓋我們可能因本次訴訟中的專利侵權而被判給的損害賠償,我們完全期望該保險單將適用於此事並提供部分承保範圍損害賠償的情況。

  • In addition, based on Management decision and as a result of our ongoing portfolio review, we have impaired $481 million, mostly related to in process R&D.

    此外,根據管理層的決定以及我們正在進行的投資組合審查,我們減值了 4.81 億美元,主要與在研研發有關。

  • The two following pipeline products constitute the majority of the impairment.

    以下兩種管道產品構成減值的大部分。

  • Obatoclax for the treatment of small cell lung cancer, and CEP-37247 anti-tumor necrosis factor for the treatment of sciatica.

    Obatoclax 用於治療小細胞肺癌,CEP-37247 抗腫瘤壞死因子用於治療坐骨神經痛。

  • We also adjusted the book value of our modafinil, Nuvigil, for the treatment of bipolar disorder to reflect the patent settlement with Mylan which will allow a generic entry in 2016.

    我們還調整了用於治療雙相情感障礙的莫達非尼 Nuvigil 的賬面價值,以反映與 Mylan 達成的專利和解,這將允許在 2016 年進入仿製藥市場。

  • On top of these items, we've excluded in our non-GAAP presentation of results the following; amortization of purchase intangible assets totaling $299 million, costs related to regulatory actions taking facilities of $25 million, acquisition restructuring and other expenses for a total benefit of $34 million and related tax benefits of $269 million.

    除了這些項目之外,我們在我們的非 GAAP 業績報告中排除了以下內容;購買無形資產的攤銷總額為 2.99 億美元,與監管行動相關的費用為 2500 萬美元,收購重組和其他費用總計 3400 萬美元,相關稅收優惠為 2.69 億美元。

  • Please review our press release and related tables for complete information including reconciliation with the GAAP figures.

    請查看我們的新聞稿和相關表格以獲取完整信息,包括與 GAAP 數據的對賬。

  • As we have 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.

    正如我們過去所指出的,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。

  • Second, exchange rate differences between this quarter and the third quarter of 2011 reduced our revenues by approximately $202 million, while having a minor positive impact on operating income.

    其次,本季度與 2011 年第三季度之間的匯率差異使我們的收入減少了約 2.02 億美元,同時對營業收入產生了輕微的積極影響。

  • The impact on revenue resulted primarily from the weakening of certain currencies primarily the Euro, the Hungarian forint, the Israeli shekel and Russian ruble relative to the US dollar.

    對收入的影響主要是由於某些貨幣相對於美元走弱,主要是歐元、匈牙利福林、以色列謝克爾和俄羅斯盧布。

  • Let me go over now to our consolidated results for the third quarter of 2012.

    現在讓我回顧一下我們 2012 年第三季度的綜合業績。

  • Net revenues for the quarter reached $5 billion, an increase of 14% compared to the third quarter of last year, or 19% in local currency terms.

    本季度淨收入達到 50 億美元,比去年第三季度增長 14%,按當地貨幣計算增長 19%。

  • Year over year, our sales grew organically by 1.3%.

    與去年同期相比,我們的銷售額有機增長了 1.3%。

  • If we eliminate the anticipated effect of Provigil going off patent, sales grew organically by 6%.

    如果我們排除 Provigil 專利到期的預期影響,銷售額將有機增長 6%。

  • Sales of generic medicines in the third quarter of 2012 were approximately $2.5 billion, including API sales to third parties of $195 million, an increase of 1% in total in US dollar terms, when compared to the third quarter of 2011.

    2012 年第三季度仿製藥銷售額約為 25 億美元,其中 API 銷售額為 1.95 億美元,以美元計算,與 2011 年第三季度相比增長 1%。

  • Our generic business in the US had a strong quarter with sales of $1.1 billion, an increase of 24% compared to the third quarter of 2011.

    我們在美國的仿製藥業務季度表現強勁,銷售額達 11 億美元,與 2011 年第三季度相比增長 24%。

  • The US generic business benefited from 20 new product launches so far this year including 9 just this quarter alone.

    今年迄今為止,美國仿製藥業務受益於 20 種新產品的推出,其中僅本季度就有 9 種。

  • In Europe, our generic business generated quarterly sales of $798 million, a decrease of 13% in dollar terms, but only 3% decrease in local currency terms, compared to the third quarter of 2011.

    在歐洲,我們的仿製藥業務季度銷售額為 7.98 億美元,與 2011 年第三季度相比,以美元計算下降 13%,但以當地貨幣計算僅下降 3%。

  • As mentioned on our previous quarterly call, to address the ongoing price and regulatory pressure in key markets in Europe, we are moving away from a pure growth focus to a profitable and sustainable growth model for generics in Europe.

    正如我們在之前的季度電話會議中提到的那樣,為了解決歐洲主要市場持續的價格和監管壓力,我們正在從純粹的增長重點轉向歐洲仿製藥的盈利和可持續增長模式。

  • As part of this model, we are being more selective in our go-to-market routes and have stopped utilizing certain discount and rebates which reduced profitability and avoid aggressively priced tenders, while still maintaining our leader position.

    作為該模型的一部分,我們在進入市場的路線上更具選擇性,並已停止使用某些降低盈利能力的折扣和回扣,並避免激進定價的投標,同時仍保持我們的領先地位。

  • Generic revenues in our rest of the world market amounted to $620 million, a decrease of 11% or 8% in local currency terms compared to the third quarter of 2011, with strong performance in Israel, Russia and other Eastern Europe markets, which was negatively offset by a decrease in generic sales in Canada, where we had exceptionally high revenues in the third quarter of 2011 in the comparison.

    我們在世界其他地區市場的仿製藥收入為 6.2 億美元,與 2011 年第三季度相比按當地貨幣計算下降 11% 或 8%,其中以色列、俄羅斯和其他東歐市場表現強勁,這與 2011 年第三季度相比產生了負面影響被加拿大仿製藥銷售額的下降所抵消,相比之下,我們在 2011 年第三季度的收入異常高。

  • Let's turn now to our branded business, where we had another good quarter across most product lines.

    現在讓我們談談我們的品牌業務,我們在大多數產品線上都有另一個良好的季度。

  • Total branded net sales in the third quarter were approximately $2 billion, an increase of 38% when compared to the third quarter of 2011.

    第三季度品牌淨銷售額總額約為 20 億美元,與 2011 年第三季度相比增長 38%。

  • Branded medicine revenues this quarter comprised 41% of our total revenues.

    本季度品牌藥收入占我們總收入的 41%。

  • Branded medicine sales in the US were $1.5 billion, an increase of 35%, compared to the third quarter of 2011.

    與 2011 年第三季度相比,美國品牌藥銷售額為 15 億美元,增長 35%。

  • This was mostly the result of the inclusion of Cephalon as well as growth of Copaxone.

    這主要是由於包含 Cephalon 以及 Copaxone 的增長。

  • In Europe, our branded business had a strong quarter with sales of $376 million, an increase of 55% or 73% in local currency terms, compared to Q3 2011.

    在歐洲,我們的品牌業務季度表現強勁,銷售額達 3.76 億美元,與 2011 年第三季度相比,以當地貨幣計算增長了 55% 或 73%。

  • Driven by the successful completion of the take-back of Copaxone sales and marketing rights in Europe, and the inclusion of Cephalon and strong sales of its medicines.

    受成功收回 Copaxone 在歐洲的銷售和營銷權、納入 Cephalon 及其藥品的強勁銷售推動。

  • In the rest of the world markets, branded sales were $177 million, an increase of 34% or 42% in local currency terms, driven primarily by unusually strong sales of Copaxone in Russia.

    在世界其他市場,品牌銷售額為 1.77 億美元,按當地貨幣計算增長 34% 或 42%,這主要是由於 Copaxone 在俄羅斯異常強勁的銷售。

  • Finally, to our OTC business, which we are very excited about.

    最後,對於我們非常興奮的場外交易業務。

  • Net revenues in the quarter were $252 million, an increase of 38% or 46% in local currency terms, compared to $183 million in the third quarter of 2011.

    本季度淨收入為 2.52 億美元,與 2011 年第三季度的 1.83 億美元相比,以當地貨幣計算增長 38% 或 46%。

  • Primarily due to sales of OTC products in the US to Procter & Gamble pursuant to a manufacturing agreement, which commenced in the fourth quarter of 2011, and growth in sales in Latin America, Europe, and in Russia.

    主要是由於根據 2011 年第四季度開始的製造協議在美國向寶潔公司銷售 OTC 產品,以及在拉丁美洲、歐洲和俄羅斯的銷售增長。

  • Moving on to non-GAAP operating income for Q3, which totaled 28.2% of total sales or $1.4 billion.

    轉到第三季度的非 GAAP 營業收入,佔總銷售額的 28.2% 或 14 億美元。

  • This is up 6% compared to Q3 2011, reflecting mainly the inclusion of Cephalon and strong sales of our branded medicines.

    這比 2011 年第三季度增長了 6%,主要反映了 Cephalon 的納入和我們品牌藥物的強勁銷售。

  • Non-GAAP net income and fully diluted earnings per share for the quarter were $1.1 billion, and $1.28 for EPS, unchanged, and up 2% respectively compared to Q3 2011.

    與 2011 年第三季度相比,本季度非美國通用會計準則淨收入和完全稀釋後每股收益為 11 億美元,每股收益為 1.28 美元,沒有變化,分別增長 2%。

  • For the third quarter of 2012, the weighted average share count for the fully diluted earnings per share calculation was $869 million, shares on GAAP basis, and $870 million shares on non-GAAP basis.

    2012 年第三季度,計算完全稀釋後每股收益的加權平均股數為 8.69 億美元,按 GAAP 計算,按非 GAAP 計算,為 8.7 億美元。

  • Turning next to profit margin and a operating expenses.

    接下來轉向利潤率和運營費用。

  • Non-GAAP gross profit margin for the quarter was 58.6% in the third quarter, compared to 56.4% in Q3 2011.

    第三季度非美國通用會計準則毛利率為 58.6%,而 2011 年第三季度為 56.4%。

  • This improvement is a result of the increased contribution from branded medicines primarily due to the integration of Cephalon and higher sales of Copaxone.

    這一改善是品牌藥物貢獻增加的結果,主要是由於 Cephalon 的整合和 Copaxone 的更高銷售額。

  • Net R&D non-GAAP expenses reached $319 million for the quarter or 6.4% of total sales.

    本季度非 GAAP 淨研發費用達到 3.19 億美元,佔總銷售額的 6.4%。

  • This quarter compared to $227 million or 5.2% of total sales in the third quarter of 2011, mostly reflecting the inclusion of Copaxone.

    本季度與 2011 年第三季度的 2.27 億美元銷售額或總銷售額的 5.2% 相比,主要反映了 Copaxone 的納入。

  • R&D expenses to date are lighter than what we communicated to you as part of the 2012 guidance back in May, mainly due to ongoing review of our product pipeline and focusing, and subsequent delay in some development milestones.

    迄今為止的研發費用比我們在 5 月份作為 2012 年指南的一部分向您傳達的要少,這主要是由於我們正在對產品線和重點進行審查,以及隨後一些開發里程碑的延遲。

  • However, we do expect these expenses to go up during the last quarter of 2012.

    然而,我們確實預計這些費用在 2012 年最後一個季度會增加。

  • Selling and marketing expenses for the quarter totaled $903 million, on a non-GAAP basis, compared to $796 million in the third quarter of 2011.

    本季度銷售和營銷費用總計 9.03 億美元(按非公認會計原則計算),而 2011 年第三季度為 7.96 億美元。

  • The increase in dollar terms was primarily due to the inclusion of Cephalon as well as the take-back of distribution and marketing responsibilities for Copaxone in Europe.

    以美元計算的增長主要是由於納入了 Cephalon 以及收回了 Copaxone 在歐洲的分銷和營銷責任。

  • This was partially offset by exchange rate differences and lower royalty payment on generic medicines in the US.

    這部分被匯率差異和美國仿製藥的較低特許權使用費所抵消。

  • Total G&A expenses this quarter were $292 million, compared with $112 million in Q3 last year, primarily due to gains recorded in the third quarter of 2011 that offset our expenses in that quarter, as well as higher expenses in the current quarter due to the inclusion of Cephalon.

    本季度的 G&A 總費用為 2.92 億美元,而去年第三季度為 1.12 億美元,這主要是由於 2011 年第三季度記錄的收益抵消了我們在該季度的費用,以及本季度由於納入費用而增加的費用中樞。

  • We recorded $73 million of financial expenses on non-GAAP basis in Q3 compared with $67 million of financial expenses in the comparable quarter in 2011.

    我們在第三季度記錄了 7300 萬美元的非 GAAP 財務費用,而 2011 年同期為 6700 萬美元。

  • The increase is mainly due to a higher interest expense resulting from the additional debt incurred to finance the acquisition of Cephalon and Taiyo.

    增加的主要原因是為收購 Cephalon 和 Taiyo 而產生的額外債務導致利息支出增加。

  • This was partially offset by gains from exchange rate fluctuation and hedging activity during the quarter, compared with losses in these items in the third quarter of 2011.

    與 2011 年第三季度這些項目的虧損相比,本季度匯率波動和對沖活動帶來的收益部分抵消了這一增長。

  • The provision of non-GAAP tax for the third quarter of 2012 was approximately 16%, and amounted to $212 million on pretax non-GAAP income of $1.3 billion.

    2012 年第三季度的非美國通用會計準則稅項撥備約為 16%,稅前非美國通用會計準則收入為 13 億美元,總額為 2.12 億美元。

  • This compared to $119 million on pretax income of $1.2 billion in the third quarter of 2011.

    相比之下,2011 年第三季度的稅前收入為 12 億美元,為 1.19 億美元。

  • We expect the tax provision to be lower next quarter and for the full year of 2012, we expect a slightly higher annual tax rate compared to 2011.

    我們預計下一季度和 2012 年全年的稅收撥備將比 2011 年略高。

  • This is in line with our prior guidance.

    這符合我們之前的指導。

  • Cash flow from operation, during the quarter was slightly higher than $1 billion, compared to $482 million in the third quarter of 2011, an increase of 117%.

    本季度運營現金流略高於 10 億美元,與 2011 年第三季度的 4.82 億美元相比增長了 117%。

  • Free cash flow, which excludes net capital expenditure and dividends, was $577 million compared to the notably low $2 million in the third quarter of 2011.

    不包括淨資本支出和股息的自由現金流為 5.77 億美元,而 2011 年第三季度為 200 萬美元,這一數字明顯較低。

  • Cash and marketable securities on September 30, 2012 amounted to $2 billion.

    2012 年 9 月 30 日的現金和有價證券總額為 20 億美元。

  • Cash flow for the fourth quarter is expected to be stronger.

    預計第四季度的現金流會更強勁。

  • During the quarter, there were no shares repurchased.

    本季度,沒有股票回購。

  • Since the beginning of 2012 Teva repurchased 15.4 million shares for approximately $667 million, as part of the $3 billion share repurchase plan that was authorized in December 2011.

    自 2012 年初以來,Teva 以約 6.67 億美元的價格回購了 1540 萬股股票,作為 2011 年 12 月批准的 30 億美元股票回購計劃的一部分。

  • As we previously noted, we maintain our flexibility to commence, carry out or suspend the buyback program from time to time depending on a wide variety of factors and taking into account various corporate priorities.

    正如我們之前指出的那樣,我們保持靈活性,根據各種因素並考慮到各種公司優先事項,不時開始、執行或暫停回購計劃。

  • On October 30, 2012, Teva's Board approved a quarterly dividend for the third quarter of ILS1 per share.

    2012 年 10 月 30 日,Teva 董事會批准了每股 ILS1 的第三季度季度股息。

  • Based on the exchange rate on October 30, 2012 of the shekel to the US dollar, this translates into approximately $0.257 per share or a total amount of approximately $223 million.

    根據 2012 年 10 月 30 日謝克爾對美元的匯率,這相當於每股約 0.257 美元或總額約為 2.23 億美元。

  • Thank you all for your time and attention this morning.

    感謝大家今天早上的時間和關注。

  • I would now like to turn the call back to Jeremy for his closing remarks.

    我現在想將電話轉回給傑里米,聽取他的結束語。

  • Jeremy?

    傑里米?

  • - President and CEO

    - President and CEO

  • Thank you, Eyal.

    謝謝你,埃亞爾。

  • In closing, I'm confident we are creating the right strategy to deliver an even stronger overall business, coupled with greater innovation over the next several years as we build upon our key assets, recruit top talent, and identify value drivers that will reshape the Company's future.

    最後,我相信我們正在製定正確的戰略,以提供更強大的整體業務,並在未來幾年內進行更大的創新,因為我們將建立我們的關鍵資產、招募頂尖人才並確定將重塑我們的價值驅動因素。公司的未來。

  • It will take time for us to recognize the full value of some of our efforts.

    我們需要時間來認識到我們的一些努力的全部價值。

  • Others are already showing positive impacts.

    其他人已經顯示出積極的影響。

  • However, we are committed to aggressively drive changes to enhance Teva's ability to provide real solutions in the dynamic healthcare environment, build and create opportunities and deliver sustainable shareholder return.

    然而,我們致力於積極推動變革,以增強 Teva 在動態醫療保健環境中提供真正解決方案、創造和創造機會並提供可持續股東回報的能力。

  • I look forward to a more in-depth discussion around our strategy with all of you during our Investor Day scheduled for December 11 in New York.

    我期待在定於 12 月 11 日在紐約舉行的投資者日期間與大家就我們的戰略進行更深入的討論。

  • At that time, we will discuss our strategy and share the details of our R&D programs, manufacturing capabilities, global brand and generic businesses, including insight into our commitment to sustain and grow our multiple sclerosis franchise, and where we see opportunities for both Copaxone and programs such as laquinimod.

    屆時,我們將討論我們的戰略並分享我們的研發計劃、製造能力、全球品牌和仿製藥業務的細節,包括深入了解我們維持和發展多發性硬化症特許經營權的承諾,以及我們在哪些方面看到了 Copaxone 和程序,例如拉喹莫德。

  • In addition, you will also have the opportunity to meet a selection of executives from around the Company who together with others provide the core of a world leading management team.

    此外,您還將有機會會見來自公司各地的精選高管,他們與其他人一起構成了世界領先的管理團隊的核心。

  • In closing then, I'd like to thank you for joining us today and would like to open the call up for questions.

    最後,我要感謝您今天加入我們,並想公開提問。

  • Operator

    Operator

  • Thank you.

    謝謝你。

  • We'll now begin the question-and-answer session.

    我們現在開始問答環節。

  • (Operator Instructions)

    (操作員說明)

  • David Buck, Buckingham Research.

    大衛·巴克,白金漢研究中心。

  • - Analyst

    - Analyst

  • Yes, thanks for taking the question.

    是的,謝謝你提出這個問題。

  • Just a couple of quick ones maybe for Jeremy.

    Jeremy 可能只是幾個快速的。

  • Can you talk about what the benefit was in the quarter going forward from some of the actions taken in the US in terms of inventory reductions in both the brand and generic businesses.

    你能談談美國在品牌和仿製藥業務的庫存減少方面採取的一些行動在本季度帶來的好處嗎?

  • You talked a little bit about profitability focus in Europe.

    您談到了歐洲的盈利重點。

  • Can you talk about what's changed in the US in terms of the businesses?

    你能談談美國在商業方面發生了什麼變化嗎?

  • And then just a quick one for Bill if he's on, just on generic pricing trends in the US.

    然後,如果他在場,就為比爾快速介紹一下美國的一般定價趨勢。

  • Thanks.

    謝謝。

  • - President and CEO

    - President and CEO

  • Good morning, David.

    早上好,大衛。

  • I think it's probably easier for Bill and Alan who are both in, both on and can give you good color on both questions so why don't I hand it over to them.

    我認為對於 Bill 和 Alan 來說,這可能更容易,他們都參與其中,並且可以在這兩個問題上給你很好的色彩,所以我為什麼不把它交給他們。

  • - President and CEO - Americas

    - President and CEO - Americas

  • Hey, David.

    嘿,大衛。

  • Good morning.

    早上好。

  • With respect to the inventory, the DSA continues to have positive impact for us in the long run.

    關於庫存,從長遠來看,DSA 繼續對我們產生積極影響。

  • There was initial charge which cost us something in the first and second quarter, but really paying a lot of benefit right now.

    初始費用在第一季度和第二季度讓我們付出了一些代價,但現在確實付出了很多好處。

  • With respect to the price increase we took in Copaxone, because of the DSA agreements, we were able to immediately recognize those changes.

    關於我們在 Copaxone 的價格上漲,由於 DSA 協議,我們能夠立即認識到這些變化。

  • So that's a real positive for us on the inventory.

    所以這對我們的庫存來說是一個真正的積極因素。

  • Most of our inventory on the branded side has been brought down to under 20 days.

    我們品牌方面的大部分庫存已減少到 20 天以下。

  • And we think that's a very manageable place to keep it, and that of course, allows us on these price increase opportunities to get as much benefit as possible.

    我們認為這是一個非常易於管理的地方來保留它,當然,這使我們能夠利用這些價格上漲的機會獲得盡可能多的利益。

  • With respect to the pricing on generics, we continue to see that mid single digit price erosion that's has been really historic now for the last couple of years.

    關於仿製藥的定價,我們繼續看到在過去幾年中真正具有歷史意義的中個位數價格下降。

  • - Analyst

    - Analyst

  • Great.

    偉大的。

  • If I could just sneak one in maybe on Copaxone or the MS category.

    如果我能偷偷加入 Copaxone 或 MS 類別。

  • What's the view for the ability for the category to sustain price increases as we look at new entrants next year?

    當我們在明年觀察新進入者時,對該類別維持價格上漲的能力有何看法?

  • - President and CEO - Americas

    - President and CEO - Americas

  • Well, David, that's a great question and really with respect to Copaxone and our pricing, we've never been a price leader.

    好吧,大衛,這是一個很好的問題,就 Copaxone 和我們的定價而言,我們從來都不是價格領導者。

  • That's not been our strategy.

    那不是我們的策略。

  • We've always kept ourselves in the game.

    我們一直在比賽中保持自我。

  • We are over 40% share.

    我們的份額超過 40%。

  • The standard of care, if you will, in this business and we think it's appropriate for us to be priced at the higher end of the group, but certainly not the highest price strategy or the highest priced product.

    護理標準,如果你願意的話,在這個行業中,我們認為我們在集團的高端定價是合適的,但肯定不是最高價格策略或最高價格產品。

  • That's always been our pricing strategy.

    這一直是我們的定價策略。

  • Where it's going to go with new entrants in, that's going to be very interesting for us to see and we'll just have to wait.

    新進入者將走向何方,這對我們來說將是非常有趣的,我們只需要等待。

  • Operator

    Operator

  • Douglas Tsao, Barclays.

    Douglas Tsao,巴克萊銀行。

  • - Analyst

    - Analyst

  • Good morning.

    早上好。

  • Just a quick follow-up question on laquinimod.

    只是關於拉喹莫德的快速跟進問題。

  • You indicated that you have an FTA from the FDA regarding getting the disability indication.

    你表示你有 FDA 的關於獲得殘疾適應症的自由貿易協定。

  • So would you be able to submit for disability with just the additional Phase III, the CONCERTO data, in addition, combined with the trials that you've already completed?

    那麼,您能否僅通過額外的 III 期、CONCERTO 數據以及您已經完成的試驗提交殘疾申請?

  • - President and CEO

    - President and CEO

  • Thanks, Doug.

    謝謝,道格。

  • Why don't we ask Michael who's on the line to answer that.

    為什麼我們不請在線的 Michael 來回答這個問題。

  • - President of Global R&D, Chief Scientific Officer

    - President of Global R&D, Chief Scientific Officer

  • Yes, thank you.

    是的,謝謝。

  • Well, at the present time we're about to start CONCERTO.

    好吧,目前我們即將開始 CONCERTO。

  • We certainly have a special agreement with the FDA in this regard with this particular study.

    在這方面,我們當然與 FDA 就這項特定研究達成了特別協議。

  • It's a two year study.

    這是一個為期兩年的研究。

  • We're very excited about laquinimod because it has its effect not only on relapse remission, but importantly, on what matters profoundly to patients, which is progression of disability and also maintenance of brain volumes.

    我們對拉喹莫德感到非常興奮,因為它不僅對緩解復發有影響,而且重要的是,對患者來說意義重大,即殘疾進展和腦容量維持。

  • The only product that has this particular quality to reverse the deterioration in brain volume in MS. The exact regulatory strategy is, while we have permission, we really haven't decided exactly what route to follow.

    唯一具有這種特殊品質的產品可以逆轉 MS 患者腦容量的退化。確切的監管策略是,雖然我們獲得了許可,但我們確實還沒有決定到底要遵循什麼路線。

  • This will depend on the results that we have.

    這將取決於我們的結果。

  • But we have numerous options open to us.

    但是我們有很多選擇。

  • We're very excited about laquinimod.

    我們對拉喹莫德感到非常興奮。

  • Offers a unique opportunity to have impact on those issues that are very worrying to patients, which is progression of disability and actually loss of brain volume.

    提供了一個獨特的機會來對患者非常擔心的那些問題產生影響,這些問題是殘疾的進展和實際上腦容量的損失。

  • Very unique in its mechanism, and so we're continuing with CONCERTO and also looking at other opportunities for laquinimod in this space.

    它的機制非常獨特,因此我們將繼續使用 CONCERTO 並尋找 laquinimod 在該領域的其他機會。

  • - Analyst

    - Analyst

  • Okay.

    好的。

  • Great.

    偉大的。

  • And then just one other question in terms of Europe, you indicated that you are perhaps scaling back the strategy in terms of perhaps being a little bit more selective in terms of the markets and products that you compete to maximize profitability rather than focus on just simply revenue.

    然後是關於歐洲的另一個問題,你表示你可能正在縮減戰略,可能在你競爭的市場和產品方面更具選擇性,以最大限度地提高盈利能力,而不是僅僅專注於簡單的收入。

  • Just curious in terms of the competitive landscape if you see that occurring with some of your competitors as well in terms of perhaps trying to sense sort of the more rational behavior or more rational competitive landscape today.

    只是好奇競爭格局,如果你看到你的一些競爭對手發生這種情況,以及可能試圖感知今天更理性的行為或更理性的競爭格局。

  • - President and CEO

    - President and CEO

  • Let's ask -- we've got Rob here.

    讓我們問一下——我們這裡有 Rob。

  • Let him ask -- why don't you have a quick run on this one?

    讓他問 - 你為什麼不快速運行一下這個?

  • - President and CEO, Teva Europe

    - President and CEO, Teva Europe

  • Thanks for the question, Douglas.

    謝謝你的問題,道格拉斯。

  • First of all, we are clear market leader in Europe, so we have a position where we do not necessarily need to compete for every little bit of market share gain and we can be much more selective in our growth approach going forward.

    首先,我們在歐洲是明顯的市場領導者,因此我們所處的位置不一定需要為每一點市場份額的增長而競爭,我們可以在未來的增長方式中更具選擇性。

  • So we focus strongly on profitable growth and we've stepped away from some of the very aggressive tenders or in some cases discounts.

    因此,我們非常關注盈利增長,我們已經放棄了一些非常激進的招標或在某些情況下的折扣。

  • As to many of our competitors, they are not market leader, right, we are, so I don't think they can quite follow that strategy.

    至於我們的許多競爭對手,他們不是市場領導者,對,我們是,所以我認為他們不能完全遵循這一戰略。

  • But I would definitely hope that also they find a more rational approach in some of the tender pricing.

    但我絕對希望他們也能在一些招標定價中找到更合理的方法。

  • - Analyst

    - Analyst

  • Okay.

    好的。

  • Great.

    偉大的。

  • Thank you very much.

    非常感謝。

  • Operator

    Operator

  • Gregg Gilbert, Bank of America.

    格雷格吉爾伯特,美國銀行。

  • - Analyst

    - Analyst

  • Thanks, good morning.

    謝謝,早上好。

  • A couple.

    一對夫婦。

  • In light of the new oral composition in the MS space can you comment on the potential for the space to move towards combination therapy over time, or do you think that will be price competitive or are there other technical hurdles as compared to other therapeutic areas.

    鑑於 MS 領域的新口服成分,您能否評論該領域隨著時間的推移轉向聯合治療的潛力,或者您認為這將具有價格競爭力,或者與其他治療領域相比是否存在其他技術障礙。

  • And then, Jeremy, anything other than Animal Health that you think might not be core to Teva.

    然後,Jeremy,除了 Animal Health 之外,您認為可能不是 Teva 核心的任何東西。

  • You seem willing to talk about Irvine and Animal Health today, but can you talk about whether anything else is under your scrutiny as to whether it's core or non-core.

    您今天似乎願意談論爾灣和動物健康,但您能否談談是否有其他任何事情在您的審查之下,無論是核心還是非核心。

  • And lastly, Jeremy, more conceptually on your expense base as you take a hard look at everything, COGS, R&D, SG&A, do you want investors to expect the potential for a large amount of savings to fall to the bottom line over time, or should the thought be more about reallocation or reinvestment of such savings into more productive areas, just a more conceptual crack at that.

    最後,Jeremy,當你認真審視所有事物時,從概念上講,你的費用基礎,COGS,R&D,SG&A,你是否希望投資者期望大量節省的潛力隨著時間的推移下降到底線,或者應該更多地考慮將這些儲蓄重新分配或再投資到更俱生產力的領域,這只是一個更概念性的破解。

  • Thanks.

    謝謝。

  • - President and CEO

    - President and CEO

  • Hi, Gregg.

    嗨,格雷格。

  • Three big questions.

    三個大問題。

  • Let me just try and break them down.

    讓我試著把它們分解一下。

  • First of all, I'd like if we can, have a quick discussion on the combo strategy and then we'll come to your question of core assets that we would consider disposing of and lastly the cost structure of the Company.

    首先,如果可以的話,我想快速討論一下組合策略,然後我們會回答你關於我們會考慮出售的核心資產的問題,最後是公司的成本結構。

  • I'll talk a little bit about the last two and then maybe Eyal will talk a little bit about that.

    我會稍微談談最後兩個,然後也許 Eyal 會談談這個。

  • Just let me just say, Copaxone and the experience that Teva's had over the years has been spectacular in both understanding the disease and also having contact with patients.

    我只想說,Copaxone 和 Teva 多年來的經驗在了解疾病和與患者接觸方面都非常出色。

  • And so we really have a very deep understanding indeed.

    所以我們確實有非常深刻的理解。

  • We've got over 1.3 million patient years of safety record of dealing with these patients, and we understand a lot about the disease, and as we look at it, it becomes more and more clear that the future holds a different set of paradigms for how the patients will need to be treated.

    我們有超過 130 萬患者年的治療這些患者的安全記錄,我們對這種疾病了解很多,當我們審視它時,越來越清楚的是,未來會有一套不同的範例病人需要如何治療。

  • This is not unusual in disease areas that are evolving.

    這在不斷發展的疾病領域並不罕見。

  • Certainly single dose of a single drug which is tremendously good like Copaxone can lead the way in understanding what might come in the future.

    當然,像 Copaxone 這樣非常好的單劑量單一藥物可以引領理解未來可能發生的事情。

  • With regard to the future, let me ask Michael to give a sense of how we look at the orals and how they fit into that kind of a concept.

    關於未來,讓我請邁克爾介紹一下我們如何看待口述以及它們如何適應這種概念。

  • - President of Global R&D, Chief Scientific Officer

    - President of Global R&D, Chief Scientific Officer

  • Thank you, Jeremy.

    謝謝你,傑里米。

  • Thank you, Gregg.

    謝謝你,格雷格。

  • Very important question and of course just to amplify what Jeremy said, when you look at other chronic diseases, combination therapy is very usual, not that usual in MS. As we evaluate potential combinations we're interested in complementarity.

    非常重要的問題,當然只是為了進一步說明 Jeremy 所說的,當您查看其他慢性疾病時,聯合療法非常常見,但在 MS 中並不常見。當我們評估潛在的組合時,我們對互補性感興趣。

  • The first thing that patients want is ways to have impact on the disease, the progression, the disability, as well as the relapse rate and so we're very interested in drugs that are complementary in actions, different in their effects, and in particular, these are drugs that patients are going to be on for a long time.

    患者首先想要的是對疾病、進展、殘疾以及復發率產生影響的方法,因此我們對作用互補、作用不同的藥物非常感興趣,尤其是,這些是患者要長期服用的藥物。

  • Copaxone is one drug with this incredible safety record, more than 20 years' experience, great efficacy.

    Copaxone 是一種具有這種令人難以置信的安全記錄的藥物,超過 20 年的經驗,非常有效。

  • Laquinimod is another drug that acts in a different way, acts on a totally different pathway, and actually has major effect on progression and brain volume.

    拉喹莫德是另一種以不同方式起作用的藥物,作用於完全不同的途徑,實際上對進展和腦容量有重大影響。

  • So we're of course very interested to look at combinations, not only in terms of subcutaneous combinations with Copaxone, but also looking at oral combinations with laquinimod and as such, we're looking -- the most important thing is safe combinations, we need.

    因此,我們當然非常有興趣研究組合,不僅在與 Copaxone 的皮下組合方面,而且也在研究與拉喹莫德的口服組合,因此,我們正在尋找 - 最重要的是安全組合,我們需要。

  • We want to look at drugs in particular that have long safety records.

    我們特別想研究具有長期安全記錄的藥物。

  • Of course, we're considering newer orals such as the S1P1 inhibitors, the NRF2 activators, but each of them has particular liabilities and we're going to assess each of them as potential combinations with oral laquinimod.

    當然,我們正在考慮更新的口服藥物,例如 S1P1 抑製劑、NRF2 激活劑,但它們中的每一種都有特定的缺點,我們將評估它們中的每一種作為與口服拉喹莫德的潛在組合。

  • And then of course, because of mechanism of action, complementarity, great safety record, we're excited about the combination of Copaxone with laquinimod in novel formulations.

    當然,由於作用機制、互補性和良好的安全記錄,我們對 Copaxone 與拉喹莫德在新配方中的組合感到興奮。

  • - President and CEO

    - President and CEO

  • Let me walk on just a little couple things, as Michael has said, for us, the critical fact here is safety, and as we look at the combination with other orals, we really must look at the side effects of some of these orals, some of them which are already in the market, others of which are being developed and our intent here is to understand deeply some of the trends that we're seeing in safety profiles coming out on publications.

    讓我談談一些小事,正如邁克爾所說,對我們來說,這裡的關鍵事實是安全,當我們考慮與其他口服藥物的組合時,我們真的必須看看其中一些口服藥物的副作用,其中一些已經上市,另一些正在開發中,我們的目的是深入了解我們在出版物中看到的安全簡介中的一些趨勢。

  • And it's important to us because we think we can drive the area of MS to a whole new level as we start to examine this type of approach.

    這對我們很重要,因為我們認為當我們開始研究這種方法時,我們可以將 MS 領域推向一個全新的水平。

  • Let me just talk quickly about the two other points you raised.

    讓我快速談談你提出的另外兩點。

  • One was have we looked at assets that aren't core.

    一是我們是否查看了非核心資產。

  • Yes, we have.

    是的我們有。

  • We continue to do that.

    我們繼續這樣做。

  • We will definitely be bringing over the next period of time a hard look at some of these assets that simply don't fit with us or would be better suited with others.

    我們肯定會在接下來的一段時間內認真審視其中一些根本不適合我們或更適合其他資產的資產。

  • In part, the way we look at this is to consider what are the things that are best partnered with third parties, what are the things that we simply believe that should be sold up and monetized, and lastly, we're looking at also those that we think that should be stopped.

    在某種程度上,我們看待這個問題的方式是考慮哪些東西最適合與第三方合作,哪些東西我們認為應該出售和貨幣化,最後,我們也在考慮那些我們認為應該停止。

  • So there's a whole sequence of events there.

    所以那裡有一整套事件。

  • And I'll turn over briefly to Eyal.

    我將簡要地交給 Eyal。

  • Your last question related to the cost structure and savings in this.

    你的最後一個問題與成本結構和節省的成本有關。

  • One of the first things I did when we got here was to ask Eyal with his team to lead a really solid review of not just our cost structure, but really the basic framework of the Company and we're able to unpack a lot of information out of that, leading me to believe that over time there's a tremendous amount of efficiency and capability that we can build into the Company as we reshape it.

    當我們到達這裡時,我做的第一件事就是請 Eyal 和他的團隊領導一次真正可靠的審查,不僅要審查我們的成本結構,還要審查公司的基本框架,我們能夠解壓縮很多信息出於這一點,讓我相信,隨著時間的推移,我們可以在重塑公司時為公司打造巨大的效率和能力。

  • So Eyal, perhaps you'd make a comment on that.

    Eyal,也許你會對此發表評論。

  • - CFO

    - CFO

  • Thanks.

    謝謝。

  • A few things.

    一些東西。

  • Jeremy, you mentioned, over the past few months we've taken a very, very deep look at the way we spend money and drew many conclusions and built a plan, a long-term plan to reshape Teva and do a big effort on how we optimize our expenses.

    傑里米,你提到,在過去的幾個月裡,我們非常、非常深入地審視了我們花錢的方式,得出了許多結論,並製定了一個計劃,一個重塑 Teva 的長期計劃,並在如何我們優化我們的開支。

  • We'll discuss that in our Analyst Day, December 11th.

    我們將在 12 月 11 日的分析師日討論這個問題。

  • I don't want to preempt.

    我不想先發製人。

  • However, you asked about reallocation of cost saving and what do we plan to do with that.

    但是,您詢問了成本節約的重新分配以及我們打算如何處理。

  • We're a pharmaceutical Company.

    我們是一家製藥公司。

  • We want to free up resources and spend more money on R&D if we can in the future, and of course, this is part of our plans of cost saving and being more efficient.

    如果未來可以的話,我們希望騰出資源,在研發上投入更多的資金,當然,這也是我們節約成本和提高效率計劃的一部分。

  • Operator

    Operator

  • Corey Davis, Jefferies.

    科里戴維斯,傑富瑞。

  • - Analyst

    - Analyst

  • Thanks very much.

    非常感謝。

  • Two questions.

    兩個問題。

  • First with the charge that you took to the R&D that included that bipolar indication of Nuvigil, does that mean that you're no longer going to pursue that indication, that you won't file it with the FDA?

    首先,您對包括 Nuvigil 的雙極適應症在內的研發的指控是否意味著您將不再追求該適應症,您不會向 FDA 提交它?

  • And second question, with your new market strategy over in Europe to focus on the more profitable growth, does that mean that you're going to have to go through more periods of revenue declines to improve the profitability on that revenue until it hits some sort of new steady state equilibrium.

    第二個問題,隨著你們在歐洲的新市場戰略專注於更有利可圖的增長,這是否意味著你們將不得不經歷更多的收入下降時期來提高收入的盈利能力,直到它達到某種程度新的穩態平衡。

  • - President and CEO

    - President and CEO

  • Let's walk back on that and perhaps what we can do is, why don't you deal with Europe first and we'll talk about the pipeline subsequently.

    讓我們回顧一下,也許我們能做的是,你為什麼不先處理歐洲,然後我們再討論管道。

  • - President and CEO, Teva Europe

    - President and CEO, Teva Europe

  • Okay.

    好的。

  • Happy to do so.

    很高興這樣做。

  • Good morning, Corey.

    早上好,科里。

  • Frankly, for the European business going -- Europe is in what has been for the last years, very much in the control of government issued reforms, resulting in some price cuts, increased penetration of generics.

    坦率地說,對於歐洲企業的發展——歐洲在過去幾年一直處於什麼狀態,在很大程度上控制著政府發布的改革,導致一些降價,提高仿製藥的滲透率。

  • And there's not so much that we as a Company can do about it.

    作為一家公司,我們對此無能為力。

  • What we can do is the approach that we take to that market.

    我們能做的是我們對那個市場採取的方法。

  • So we have focused more on sustainable profitability, not going after every last bit of market share, but still we want to maintain our leading market position, right.

    所以我們更加關注可持續的盈利能力,而不是追求每一點市場份額,但我們仍然希望保持我們的領先市場地位,對吧。

  • On top, we have really also adapted our organization and our teams where we've already reduced about 2% of our commercial workforce this year in Europe and going forward we're doing a bit more of that with alignment and without impacting the commercial power.

    最重要的是,我們確實還調整了我們的組織和我們的團隊,今年我們已經在歐洲減少了大約 2% 的商業勞動力,並且展望未來,我們將在不影響商業力量的情況下做更多的調整.

  • It's very difficult to predict what the European markets are going to do, but there's good opportunities, for instance, in Italy where there's new legislation that will give an increased penetration.

    很難預測歐洲市場將要做什麼,但有很好的機會,例如,在意大利,新的立法將提高滲透率。

  • Recently we've seen very good increase in penetration of generics in France as well.

    最近,我們也看到仿製藥在法國的滲透率有了很好的增長。

  • So frankly, I do not expect that the revenue's going to go much below what we have now.

    所以坦率地說,我不認為收入會比我們現在的收入低很多。

  • I really see midterms even very good opportunities, because Europe still is a continent with 500 million fairly wealthy people that expect and demand good healthcare services, and generics are the solution for this, and we are best placed to deliver that.

    我真的認為中期選舉甚至是非常好的機會,因為歐洲仍然是一個擁有 5 億相當富有的人的大陸,他們期望並需要良好的醫療保健服務,而仿製藥是解決這個問題的方法,而我們最有能力提供它。

  • We really have a fantastic position in that.

    我們在這方面確實處於有利地位。

  • But the very short term is going to be difficult to predict and we have adapted our approach both in profitability and organization and that's what we have decided to do.

    但短期內將很難預測,我們已經在盈利能力和組織方面調整了我們的方法,這就是我們決定要做的。

  • - President and CEO

    - President and CEO

  • And then going back to the Nuvigil question, Michael, will you handle that please.

    然後回到 Nuvigil 問題,邁克爾,請你處理這個問題。

  • - President of Global R&D, Chief Scientific Officer

    - President of Global R&D, Chief Scientific Officer

  • Yes, of course.

    是的當然。

  • Thank you, Jeremy.

    謝謝你,傑里米。

  • Thanks, Corey.

    謝謝,科里。

  • Important question.

    重要問題。

  • We do have, as you well know, positive results from the first of three Phase III studies with Nuvigil.

    如您所知,我們確實從 Nuvigil 的三項 III 期研究中的第一項獲得了積極的結果。

  • Our second study is going to read out at the -- towards the end of this year and certainly if positive, we do plan to file an sNDA for this indication.

    我們的第二項研究將在今年年底宣讀,當然如果是積極的,我們確實計劃為此適應症提交一份 sNDA。

  • This is important.

    這個很重要。

  • This will really provide another option for patients with a very serious disorder, bipolar depression, and so we're moving ahead with Nuvigil, and are encouraged by the first study, and look forward to seeing the results of the second.

    這確實會為患有非常嚴重的雙相抑鬱症的患者提供另一種選擇,因此我們正在推進 Nuvigil,並受到第一項研究的鼓舞,並期待看到第二項的結果。

  • - Analyst

    - Analyst

  • Okay.

    好的。

  • Thanks very much.

    非常感謝。

  • Operator

    Operator

  • Shivani Mohapatra, RBC Capital.

    RBC Capital 的 Shivani Mohapatra。

  • - Analyst

    - Analyst

  • Hi.

    你好。

  • Thanks for taking the question.

    感謝您提出問題。

  • I've got a couple, both for Jeremy.

    我有一對,都是給傑里米的。

  • So first, Jeremy, I know you're not giving us 2013 guidance, but when we look at our model, we see that you have a number of large first to file opportunities in 2012 and you don't have those in 2013.

    首先,Jeremy,我知道你沒有給我們 2013 年的指導,但當我們查看我們的模型時,我們發現你在 2012 年有許多大型的先申請機會,而你在 2013 年沒有。

  • So can you talk conceptually on how you see revenue and earnings growth next year?

    那麼,您能否從概念上談談您如何看待明年的收入和盈利增長?

  • And if it's not possible to grow on an organic basis, what you can do in terms of capital allocation, et cetera.

    如果不可能在有機基礎上增長,你可以在資本配置等方面做些什麼。

  • And then second, just a quick one on return on capital and return on investment.

    其次,快速介紹一下資本回報率和投資回報率。

  • You've talked about this before.

    你以前談過這個。

  • But I was wondering if you could just talk about what you think a good hurdle rate is for you when you are looking at where to invest.

    但我想知道,當你在尋找投資地點時,你是否可以談談你認為一個好的門檻利率對你來說是什麼。

  • Thank you.

    謝謝你。

  • - President and CEO

    - President and CEO

  • Shivani, good morning to you, and thanks for the question.

    Shivani,早上好,謝謝你的提問。

  • Couple questions there, both of which I'd like to have the opportunity to answer in depth.

    那裡有幾個問題,我希望有機會深入回答這兩個問題。

  • First of all, when we give guidance and secondly at the Investor Day.

    首先,當我們提供指導時,其次是在投資者日。

  • So if you don't mind, I'm going to leave those for the day that we have coming up.

    所以如果你不介意的話,我將把這些留到我們即將到來的那一天。

  • We're still in the process of completing our work plan and we will provide formal guidance no later than December 11th.

    我們仍在完成我們的工作計劃,我們將在 12 月 11 日之前提供正式指導。

  • - Analyst

    - Analyst

  • Okay.

    好的。

  • Does that mean you could give us guidance before December 11th?

    這是否意味著您可以在 12 月 11 日之前給我們提供指導?

  • - President and CEO

    - President and CEO

  • I'll just repeat, we'll not guide until December 11th.

    我再說一遍,我們要到 12 月 11 日才會進行指導。

  • - Analyst

    - Analyst

  • Okay.

    好的。

  • Thanks.

    謝謝。

  • Operator

    Operator

  • Tim Chiang, CRT Capital.

    CRT Capital 的 Tim Chiang。

  • - Analyst

    - Analyst

  • Hi.

    你好。

  • Thanks.

    謝謝。

  • Jeremy, I wanted to ask you a little bit about how you sort of view the pharmaceutical industry globally going forward, heading into 2013.

    傑里米,我想問你一些關於你如何看待全球製藥業在 2013 年的發展。

  • I mean, you've traditionally come from a branded background and certainly Teva's the largest generic drug Company in the world.

    我的意思是,您傳統上來自品牌背景,當然 Teva 是世界上最大的仿製藥公司。

  • Maybe just a really high level question, do you expect to see more consolidation coming from Teva in 2013?

    也許只是一個非常高層次的問題,您是否預計 2013 年 Teva 會出現更多整合?

  • - President and CEO

    - President and CEO

  • Well, broad question.

    好吧,廣泛的問題。

  • So more consolidation meaning larger M&A, just let me clarify that question.

    所以更多的整合意味著更大的併購,讓我澄清一下這個問題。

  • - Analyst

    - Analyst

  • Yes, absolutely, more M&A, you know, certainly with the debt markets being so accessible by pharmaceutical companies, would it make sense for Teva to increase its leverage?

    是的,當然,更多的併購,你知道,當然隨著製藥公司如此容易進入債務市場,Teva 增加槓桿是否有意義?

  • - President and CEO

    - President and CEO

  • Good point.

    好點子。

  • Look, I think first of all, going into 2013 we're going to take a very disciplined approach to M&A and considering anything that we would buy.

    看,我認為首先,進入 2013 年,我們將對併購採取非常嚴格的方法,並考慮我們將購買的任何東西。

  • I think from my perspective, yes, we will certainly look at small assets.

    我認為從我的角度來看,是的,我們肯定會關注小資產。

  • I'm not anticipating any major -- we're not anticipating leveraging up to secure large acquisitions at all.

    我不期待任何重大事件——我們根本不期待利用槓桿來確保大型收購。

  • At this stage, though, if you look at the industry as a whole you are correct with the cost of capital being quite as low, that is a lot of people are thinking hard about what they can do.

    不過,在這個階段,如果你把整個行業看成一個整體,你會發現資本成本相當低是正確的,那就是很多人都在認真思考他們能做什麼。

  • And interestingly enough, at the same time, we're also getting a lot of the pharmaceutical companies who have finally recognized that they need to be out of some of the marketplaces, are willing to divest assets that are not a clear fit with their branded.

    有趣的是,與此同時,許多製藥公司終於意識到他們需要退出某些市場,願意剝離與其品牌不明顯的資產.

  • So it's going both ways.

    所以這是雙向的。

  • I'm seeing a lot of very interesting opportunities which are crossing our desks in emerging markets and also in Europe as well.

    我看到很多非常有趣的機會出現在我們新興市場和歐洲的辦公桌上。

  • So we're going to look at them all but there's nothing -- there's no indication and you shouldn't take any indication that we're embarking on a process to leverage ourself up to secure large acquisition.

    因此,我們將研究所有這些,但沒有任何跡象——沒有跡象表明,你不應該採取任何跡象表明我們正在著手利用自己來確保大規模收購。

  • - Analyst

    - Analyst

  • Okay.

    好的。

  • Jeremy, maybe one follow-up on laquinimod.

    傑里米,也許是拉喹莫德的後續行動。

  • I know that you had indicated you're doing a third trial.

    我知道你曾表示你正在進行第三次試驗。

  • I think the market has always been a bit concerned about the efficacy with laquinimod.

    我認為市場一直有點關注拉喹莫德的療效。

  • Do you think that the market is correct in its judgment or do you think that the market has sort of missed the opportunity already that laquinimod might provide longer term?

    您認為市場的判斷是否正確,或者您是否認為市場已經錯過了拉喹莫德可能提供的長期機會?

  • - President and CEO

    - President and CEO

  • You know, Tim, I've got great respect for the market.

    你知道,蒂姆,我非常尊重市場。

  • You guys do a lot of research going around the industry and talking to different people.

    你們做了很多關於這個行業的研究,並與不同的人交談。

  • However, we had a chance to really dig into the science and understanding of laquinimod and so let me just say that we are confident that what we're seeing certainly as we look deeply into the science and I'm reiterating the science, I'm not talking about necessarily the clinical results in the past, I'm talking about the science and the clinical data that he we have at our fingertips, we're very confident about this molecule, having great potential.

    然而,我們有機會真正深入研究拉喹莫德的科學和理解,所以我只想說,我們有信心,當我們深入研究科學時,我們肯定會看到我們所看到的,我重申科學,我'我不是在談論過去的臨床結果,我在談論我們掌握的科學和臨床數據,我們對這個分子非常有信心,具有巨大的潛力。

  • Now, we're going to explore that fully, in the past that hasn't been fully explored.

    現在,我們要充分探索,在過去還沒有完全探索。

  • Let me ask Michael to step in on this.

    讓我請邁克爾介入此事。

  • It's important to remember what Michael had mentioned previously, and that is the potential not only for being a single agent, but also for being a backbone to combination therapies.

    重要的是要記住邁克爾之前提到的內容,那就是不僅有可能成為單一藥物,而且有可能成為聯合療法的支柱。

  • It's very important to understand what the kind of characteristics of a molecule would have to be to make it that.

    了解分子必須具有什麼樣的特徵才能做到這一點非常重要。

  • Michael, why don't you comment on the factors we know them a little bit about laquinimod.

    邁克爾,你為什麼不評論一下我們對拉喹莫德了解的一些因素。

  • - President of Global R&D, Chief Scientific Officer

    - President of Global R&D, Chief Scientific Officer

  • Yes, thank you Jeremy.

    是的,謝謝杰里米。

  • Laquinimod is actually a highly efficacious agent.

    拉喹莫德實際上是一種非常有效的藥物。

  • When you looked at the -- this was reported at ECTRIMS, the meta analysis of the data showed highly significant improvements in disability and in progression, but also relapse rate, as well as improvement in quality of life and also brain volume.

    當你看——這是在 ECTRIMS 上報導的,數據的元分析顯示殘疾和進展方面有非常顯著的改善,但也有復發率,以及生活質量和腦容量的改善。

  • So on all the parameters and end points that matter to the physicians and patients from relapse rate, disability, progression, which is a major issue for patients, brain volume loss, and importantly, quality of life, laquinimod had spectacular results.

    因此,在對醫生和患者重要的所有參數和終點上,從復發率、殘疾、進展(這是患者的主要問題)、腦容量損失,以及重要的生活質量,拉喹莫德取得了驚人的結果。

  • All of this in the face of an outstanding safety record, easily tolerated, no gastrointestinal side effects, no issues that really are raising any concern, a unique novel mechanism of action.

    所有這一切都擁有出色的安全記錄、易於耐受、無胃腸道副作用、沒有真正引起任何關注的問題、獨特的新穎作用機制。

  • So we're excited.

    所以我們很興奮。

  • We're going to explore this fully.

    我們將對此進行全面探索。

  • One of the Phase III studies was not adequately powered.

    其中一項 III 期研究的效力不足。

  • The first study was.

    第一項研究是。

  • The second study not.

    第二學不會。

  • If you did the meta analysis, profoundly significant results across the issues that matter to patients and doctors.

    如果您進行了薈萃分析,將會在對患者和醫生重要的問題上產生意義深遠的結果。

  • So with an outstanding safety record and tolerability.

    因此具有出色的安全記錄和耐受性。

  • Not just serious side effects but for patients, an outstanding tolerability.

    不僅是嚴重的副作用,而且對患者而言,具有出色的耐受性。

  • No serious side effects.

    沒有嚴重的副作用。

  • Operator

    Operator

  • Jami Rubin, Goldman Sachs.

    賈米魯賓,高盛。

  • - Analyst

    - Analyst

  • Hi, this is Ariel Herman in for Jami.

    嗨,我是 Jami 的 Ariel Herman。

  • So our question, we just noticed that you guys didn't do buybacks this quarter.

    所以我們的問題是,我們只是注意到你們本季度沒有進行回購。

  • We were just hoping to get an idea of the Board's appetite for increasing buybacks and/or the dividend.

    我們只是希望了解董事會對增加回購和/或股息的興趣。

  • - President and CEO

    - President and CEO

  • I'm sorry, I didn't catch the name.

    對不起,我沒聽清名字。

  • Could you repeat that again.

    你能再重複一遍嗎?

  • - Analyst

    - Analyst

  • Sorry, it's Ariel Herman.

    抱歉,我是 Ariel Herman。

  • - President and CEO

    - President and CEO

  • Hi Ariel.

    嗨,愛麗兒。

  • First of all, listen, I'm going to give you an overview philosophy of the Company and then I'll ask Eyal to comment briefly on the buyback.

    首先,聽著,我將向您簡要介紹公司的理念,然後我將請 Eyal 就回購問題簡要發表評論。

  • First of all, Teva's approach to capital allocation is and will be extremely disciplined and we are balancing the needs of our shareholders with those of business development and capital requirements internally.

    首先,Teva 的資本配置方法現在並將非常嚴格,我們正在平衡股東的需求與內部業務發展和資本需求的需求。

  • But we, all investors should feel extremely comfortable that we are conscious of the needs of the different stakeholders and we will be extremely focused on total shareholder return in that focus.

    但是我們,所有投資者都應該感到非常自在,因為我們意識到不同利益相關者的需求,我們將非常關注股東的總回報。

  • With regard to -- and very disciplined.

    關於 - 並且非常有紀律。

  • Very disciplined.

    非常有紀律。

  • Let me just ask then for Eyal to speak specifically and briefly to our share buyback program.

    那麼我只要求 Eyal 就我們的股票回購計劃進行具體而簡短的發言。

  • - CFO

    - CFO

  • Yes, just to remind, we have a $3 billion plan that was approved by our Board last December.

    是的,提醒一下,我們的董事會去年 12 月批准了一項 30 億美元的計劃。

  • We so far this year used close to $700 million of this three year program.

    今年到目前為止,我們在這個三年計劃中使用了近 7 億美元。

  • We look at buyback every quarter and make a decision where and when to enter the market, considering the corporate priority.

    我們每個季度都會考慮回購,並根據公司的優先考慮決定何時何地進入市場。

  • We paid down almost $0.5 billion in debt this quarter.

    本季度我們還清了近 5 億美元的債務。

  • We'll keep evaluating the program as we go along.

    我們將繼續評估該計劃。

  • - Analyst

    - Analyst

  • Thank you.

    謝謝你。

  • Operator

    Operator

  • David Amsellem, Piper Jaffray.

    大衛·阿姆塞勒姆、派珀·杰弗瑞。

  • - Analyst

    - Analyst

  • Hi, this is Trevor Davis on for David Amsellem.

    嗨,我是 David Amsellem 的 Trevor Davis。

  • I appreciate you taking the questions.

    感謝您提出問題。

  • So just a few quick ones on the brand business.

    所以只是關於品牌業務的幾個快速的。

  • First, what kind of life cycle management work are you doing on Treanda, given that the orphan status expiry is coming up in 2015.

    首先,考慮到孤兒地位將在 2015 年到期,您在 Treanda 上做了什麼樣的生命週期管理工作。

  • And then just two quick ones on the pipeline.

    然後只有兩個快速的管道。

  • On the tamper resistant ER Hydrocodone product, given the Phase III setback that you disclosed in the past, are you still pursuing development of this product or is this something that is not going to be a priority for you going forward?

    關於抗篡改 ER 氫可酮產品,鑑於您過去披露的 III 期挫折,您是否仍在繼續開發該產品,或者這是否不是您前進的優先事項?

  • And just lastly, on the MS franchise, are you looking at other development opportunities outside of laquinimod and Copaxone in line extensions, and is this a priority in terms of your business development.

    最後,關於 MS 特許經營權,您是否正在尋找 laquinimod 和 Copaxone 之外的其他發展機會,這是您業務發展的優先事項。

  • Thanks.

    謝謝。

  • - President and CEO

    - President and CEO

  • Terrific.

    了不起。

  • I'm sorry, again, our speaker's not playing up, I missed your name.

    再次抱歉,我們的揚聲器沒有播放,我想念你的名字。

  • Can you repeat it again.

    你能再說一遍嗎?

  • - Analyst

    - Analyst

  • Sure, it's Trevor Davis.

    當然,是特雷弗·戴維斯。

  • - President and CEO

    - President and CEO

  • Okay.

    好的。

  • Again, very blurred.

    再次,非常模糊。

  • My apologies.

    我很抱歉。

  • Maybe it's just the ear.

    也許這只是耳朵。

  • Quite a number of questions there.

    那裡有很多問題。

  • Let me first of all walk through the Treanda, and I think Treanda followed by -- Michael, why don't you handle these questions because they're all pretty much pipeline related, and then coming back to the business development, just I'll make one comment, absolutely.

    首先讓我介紹一下 Treanda,我認為 Treanda 接下來是 — 邁克爾,你為什麼不處理這些問題,因為它們幾乎都與管道相關,然後回到業務開發,只是我絕對會發表評論。

  • We are looking at multiple different opportunities in MS. It is a major strategic focus for us and this is an area which we look at as wanting to offer patients every possible benefit.

    我們正在尋找 MS 中的多種不同機會。這是我們的一個主要戰略重點,我們認為這是一個希望為患者提供一切可能的好處的領域。

  • But we also look at MS in the context of an overall neurodegenerative approach and I'll let Michael now speak briefly to the next -- to the two other questions that you had.

    但我們也在整體神經退行性方法的背景下看待 MS,我現在讓 Michael 簡短地談談下一個問題——你提出的另外兩個問題。

  • - President of Global R&D, Chief Scientific Officer

    - President of Global R&D, Chief Scientific Officer

  • Thank you, Jeremy.

    謝謝你,傑里米。

  • So we're committed of course to the life cycle management of Treanda.

    因此,我們當然致力於 Treanda 的生命週期管理。

  • As part of that, we're committed to bringing the indication for the -- front line indication for NHL to the US market.

    作為其中的一部分,我們致力於將 NHL 的前線適應症引入美國市場。

  • We recently heard that progression-free survival data from the BRIGHT study will be required to support a front line approval and we're currently examining all options to obtain this requested data.

    我們最近聽說,需要來自 BRIGHT 研究的無進展生存數據來支持前線批准,我們目前正在研究所有選項以獲得這些請求的數據。

  • This drug is, again, very useful.

    這種藥物再次非常有用。

  • It's been outstanding in terms of its effects of efficacy, and we're committed to finding a way to get this approved for front line NHL.

    它在療效方面一直很出色,我們致力於找到一種方法讓它獲得批准用於前線 NHL。

  • On the other areas, in terms of our pipeline and expansion, what's surprising and interesting about drugs like laquinimod is that they act on various inflammatory pathways that are actually important in other disorders of the nervous system, such as Alzheimer's, ALS, Huntington's, Parkinson's.

    在其他領域,就我們的管道和擴張而言,像拉喹莫德這樣的藥物令人驚訝和有趣的是,它們作用於各種炎症通路,這些通路實際上對其他神經系統疾病很重要,例如阿爾茨海默氏症、ALS、亨廷頓氏症、帕金森氏症.

  • And so we're busy of course both exploring some preclinical data, proof of concept, proof of principle, and we'll be exploring laquinimod in other areas and more of that to come on the Investor Day.

    因此,我們當然忙於探索一些臨床前數據、概念證明、原理證明,我們將在其他領域探索拉喹莫德,更多內容將在投資者日進行。

  • - Analyst

    - Analyst

  • Sounds great.

    聽起來不錯。

  • Thank you.

    謝謝你。

  • Operator

    Operator

  • Ken Cacciatore, Cowen and Company.

    Ken Cacciatore, Cowen and Company。

  • - Analyst

    - Analyst

  • Hi, thanks, guys.

    嗨,謝謝,伙計們。

  • Just following up on your discussion on laquinimod, in the Crohn's trial, was wondering if you could discuss the inverse dose response that we saw and also maybe discuss--and I know this may be preempting December 11th but maybe discuss the next moves here.

    只是跟進您在克羅恩氏試驗中關於拉喹莫德的討論,想知道您是否可以討論我們看到的反劑量反應,也可能討論——我知道這可能會搶占 12 月 11 日,但也許在這裡討論下一步行動。

  • Do you need to do another dose ranging or do you think this is ready to move into a pivotal trial.

    您是否需要進行另一次劑量範圍調整,或者您認為這已準備好進入關鍵試驗。

  • And then second question would be, you did highlight CNS and respiratory key franchises.

    然後第二個問題是,你確實強調了 CNS 和呼吸關鍵特許經營權。

  • Wondering if oncology and women's health are considerations for divestiture or are they still core to Teva going forward?

    想知道腫瘤學和女性健康是否是資產剝離的考慮因素,或者它們是否仍然是 Teva 前進的核心?

  • Thank you.

    謝謝你。

  • - President and CEO

    - President and CEO

  • Good morning to you.

    早上好。

  • Good questions, again.

    好問題,又來了。

  • Michael, would you handle both questions, please.

    邁克爾,請你處理這兩個問題。

  • I think you've got them.

    我想你已經明白了。

  • It's not so much a preempt.

    這不是一個先發製人。

  • We'll be able to go in depth in some of these things during the Investor Day and it's good that we get a chance to talk about some of them now as well.

    我們將能夠在投資者日期間深入探討其中的一些事情,我們現在也有機會討論其中的一些事情,這很好。

  • - President of Global R&D, Chief Scientific Officer

    - President of Global R&D, Chief Scientific Officer

  • So thank you, Jeremy, and thank you for the opportunity to comment on the Crohn's data.

    所以謝謝你,Jeremy,感謝你有機會評論克羅恩病的數據。

  • I would say it's very important not to over-read the Crohn's data.

    我會說不要過度閱讀克羅恩病數據非常重要。

  • This was a Phase II A study in a small number of patients.

    這是一項針對少數患者的 II A 期研究。

  • So that's very important.

    所以這非常重要。

  • If you look at the number of patients treated it was in the order of 30.

    如果你看一下接受治療的患者數量,大約有 30 人。

  • Interestingly, the laquinimod 0.5 and also 1 milligram showed effects, 0.5, the major effect, 1 milligram, slightly less robust.

    有趣的是,拉喹莫德 0.5 毫克和 1 毫克都顯示出效果,0.5 是主要效果,1 毫克則略微不太穩健。

  • And in higher doses, 1.5 and 2, there had been some dropout of patients, so the numbers were really significantly decreased from a number already that was small, as would be expected for a Phase II A trial.

    在更高的劑量下,1.5 和 2,有一些患者退出,所以這個數字確實比已經很小的數字顯著減少,正如 II A 期試驗所預期的那樣。

  • So we're encouraged by the data.

    因此,我們對數據感到鼓舞。

  • There are many potential reasons for why there might have been an inverse dose relationship.

    有許多潛在的原因可以解釋為什麼可能存在反劑量關係。

  • One of them might have been just the power to detect.

    其中之一可能只是檢測能力。

  • It is important that one of the biochemical indices for effect which is faecal calprotectin was reduced in all of them.

    重要的是,影響生化指標之一的糞便鈣衛蛋白在所有這些指標中都降低了。

  • The clinical effects were only seen in the lower dose.

    臨床效果僅見於較低劑量。

  • This encourages us to do much more rigorous now Phase II studies, focusing on dose relationship.

    這鼓勵我們現在進行更嚴格的 II 期研究,重點關注劑量關係。

  • We will sort this out.

    我們會解決這個問題。

  • We're encouraged.

    我們受到鼓舞。

  • This was an effect that occurred within a week against all outcome measures, which is quite remarkable, and I think important not to over-read the data, but it provides sufficient proof of concept for further exploration in detailed studies to follow.

    這是在一周內對所有結果測量產生的影響,這是非常顯著的,我認為不要過度閱讀數據很重要,但它為後續詳細研究的進一步探索提供了足夠的概念證明。

  • - President and CEO

    - President and CEO

  • Michael, would you -- I don't -- in case anybody thinks, we weren't trying to avoid the question on tetra hydrocodone.

    邁克爾,你會不會——我不會——萬一有人認為,我們不是在試圖迴避關於四氫可酮的問題。

  • Would you quickly comment on that.

    你會很快對此發表評論嗎?

  • - President of Global R&D, Chief Scientific Officer

    - President of Global R&D, Chief Scientific Officer

  • Yes.

    是的。

  • We missed our end point in the last study.

    我們錯過了上一項研究的終點。

  • We've revised this and continuing with the TD hydrocodone study, and we're expecting, this is a study that has some slight changes in design, and we're expecting to be successful in the next Phase III.

    我們對此進行了修改並繼續進行 TD 氫可酮研究,我們期待,這是一項在設計上有一些細微變化的研究,我們期待在下一階段 III 中取得成功。

  • We still see a tremendous opportunity, both in the opioid market for pain, and of course, non-opioid as well, which is part of our R&D perspective, and we're continuing with the TD hydrocodone trial in an effort to reach -- we're confident we can reach the appropriate end points.

    我們仍然看到了巨大的機會,無論是在止痛的阿片類藥物市場,當然還有非阿片類藥物,這是我們研發觀點的一部分,我們正在繼續進行 TD 氫可酮試驗,以達到——我們有信心能夠達到適當的終點。

  • Operator

    Operator

  • Florent Cespedes, Exane BNP.

    Florent Cespedes, Exane BNP。

  • - Analyst

    - Analyst

  • Good afternoon, gentlemen.

    下午好,先生們。

  • Thank you very much for taking my questions.

    非常感謝你回答我的問題。

  • Two quick ones.

    兩個快的。

  • Could we have more color on the competitive environment on the respiratory and on the women's health products?

    我們能否在呼吸系統和女性保健產品的競爭環境中有更多色彩?

  • How do you see their performance going forward?

    您如何看待他們未來的表現?

  • And second question on OTC, we start to see an acceleration of the OTC business.

    關於場外交易的第二個問題,我們開始看到場外交易業務的加速發展。

  • Should we continue to see this going forward?

    我們應該繼續看到這種情況嗎?

  • And could we have more color on the drivers?

    我們可以在驅動器上添加更多顏色嗎?

  • Thank you.

    謝謝你。

  • - President and CEO

    - President and CEO

  • Really as far as I can see three questions here, OTC, women's health and respiratory.

    據我所知,這裡有三個問題,OTC、女性健康和呼吸系統。

  • Let me go in inverse, I'll -- Florent, I'm going to ask Rob to comment on OTC, and then we'll go to -- and perhaps on respiratory as well.

    讓我倒過來,我會 - 弗洛倫特,我要請羅布對 OTC 發表評論,然後我們會去 - 也許還有呼吸系統。

  • I'll answer on the women's health.

    我會回答女性的健康問題。

  • With regard -- just a comment on the OTC.

    關於 - 只是對場外交易的評論。

  • I want to say that this is a -- we're very, very pleased with our -- as I mentioned, we're very pleased with our alliance.

    我想說的是——我們對我們的聯盟非常非常滿意——正如我提到的,我們對我們的聯盟非常滿意。

  • This is something that we think that P&G have been great partners to work with.

    我們認為寶潔一直是很好的合作夥伴。

  • We're learning a lot from each other.

    我們從彼此身上學到了很多東西。

  • The partnership is evolving and it continues to evolve.

    夥伴關係正在發展,並且會繼續發展。

  • We've been very successful and particularly pleased by some of the results that we're seeing, early results with Vicks.

    我們非常成功,並且對我們看到的一些結果特別滿意,Vicks 的早期結果。

  • But I think let me have Rob who is now -- we have a core set of senior people watching over this, the PG&T alliance, and so Rob whose got hands on experience with this can give you some color on it.

    但我想讓我讓 Rob 現在 - 我們有一組核心高級人員在關注這個,PG&T 聯盟,所以 Rob 有這方面的經驗可以給你一些顏色。

  • - President and CEO, Teva Europe

    - President and CEO, Teva Europe

  • With pleasure, Jeremy and Florent.

    很高興,傑里米和佛羅倫特。

  • We have launched Vicks already previous quarter in Poland and Russia and continue to see really fantastic success there.

    我們已經在上個季度在波蘭和俄羅斯推出了 Vicks,並繼續在那裡取得了巨大的成功。

  • So far, we're extremely happy.

    到目前為止,我們非常高興。

  • In Poland, for instance, Vicks is on its way to become the best OTC launch in the last 10 years.

    例如,在波蘭,Vicks 正在成為過去 10 年中最好的場外交易產品。

  • It's really doing extremely well, both in sales into pharmacies but also in the last weeks in sell-out to real patients.

    它確實做得非常好,無論是在藥店的銷售方面,還是在過去幾週對真實患者的銷售方面。

  • And for instance, in Germany, we are really outperforming with our OTC franchise, the overall market, the overall market is in a slight decline.

    例如,在德國,我們的 OTC 特許經營權確實表現出色,整個市場,整個市場略有下降。

  • We're increasing.

    我們在增加。

  • I'm confident that going forward we'll see more increase in OTC.

    我相信,未來我們會看到 OTC 的增長更多。

  • - President and CEO

    - President and CEO

  • So I think on the respiratory side, do you want to make any comments, Rob or Bill?

    所以我認為在呼吸方面,你想發表任何評論嗎,Rob 或 Bill?

  • - President and CEO, Teva Europe

    - President and CEO, Teva Europe

  • I pass it to Bill.

    我把它傳給比爾。

  • - President and CEO

    - President and CEO

  • Bill?

    賬單?

  • - President and CEO - Americas

    - President and CEO - Americas

  • Sure.

    當然。

  • Thanks for the question, Florent.

    謝謝你的問題,弗洛倫特。

  • With respect to respiratory, we're doing very well.

    在呼吸方面,我們做得很好。

  • I'm very excited with the progression for ProAir in the SABA space.

    我對 ProAir 在 SABA 領域的進展感到非常興奮。

  • We're at 51.7% share.

    我們的份額為 51.7%。

  • Our numbers, our revenues for the quarter both for ProAir and Qvar were impacted by some late charges due to healthcare reform that came in from California and a couple of other states.

    我們的數字,ProAir 和 Qvar 本季度的收入受到加利福尼亞和其他幾個州的醫療改革導致的一些滯納金的影響。

  • But absent that, both franchises actually in a weak respiratory season are progressing very nicely.

    但除此之外,實際上處於疲軟呼吸季節的兩支球隊都取得了非常好的進展。

  • TRX data as I said for ProAir is 51.7%.

    正如我所說,ProAir 的 TRX 數據是 51.7%。

  • And our TRX share is up to 26.2% in Qvar in the ICS category so we're doing real well, and in fact, our growth is up about 25% in Qvar against Q3 of 2011.

    在 ICS 類別中,我們在 Qvar 的 TRX 份額高達 26.2%,因此我們做得非常好,事實上,與 2011 年第三季度相比,我們在 Qvar 的增長率約為 25%。

  • So really progressing very well in respiratory, so we really like this space.

    所以在呼吸方面確實取得了很好的進展,所以我們真的很喜歡這個空間。

  • - President and CEO

    - President and CEO

  • Thanks, Bill.

    謝謝,比爾。

  • Michael, will you just quickly comment on the pipeline and in addition to that, briefly on women's health.

    邁克爾,你能否快速評論管道,除此之外,簡要談談女性健康。

  • I think we're running a little short on time.

    我認為我們的時間有點短。

  • - President of Global R&D, Chief Scientific Officer

    - President of Global R&D, Chief Scientific Officer

  • Thank you, Jeremy.

    謝謝你,傑里米。

  • Just to make it short, there's been some significant progress in our pipeline in respiratory, in particular in the BF Spiromax, where we've now shown bioequivalents for both the mid and high strength products.

    簡而言之,我們在呼吸系統方面取得了一些重大進展,特別是在 BF Spiromax 方面,我們現在已經展示了中高強度產品的生物等效性。

  • These are products that are combined products, corticosteroid and beta two agonists for treatment of asthma and COPD.

    這些產品是用於治療哮喘和 COPD 的組合產品、皮質類固醇和 β2 激動劑。

  • This is a big breakthrough for us.

    這對我們來說是一個很大的突破。

  • The Spiromax is a great platform and this is going to be an effective asthma medication in a novel and easy to use inhaler and we're looking to file this in Europe early 2013.

    Spiromax 是一個很棒的平台,它將成為一種有效的哮喘藥物,採用新穎且易於使用的吸入器,我們希望在 2013 年初在歐洲提交申請。

  • On the women's health, of course Teva's place in contraception is profound.

    在女性健康方面,Teva 在避孕方面的地位當然是深遠的。

  • We're looking at all kinds of novel ways to improve contraception, both devices as well as approaches.

    我們正在尋找各種改進避孕措施的新穎方法,包括設備和方法。

  • But we're going beyond that, looking at women's health in areas of unmet need beyond contraception and these include things like endometriosis, fibrosis, these are important for the future.

    但我們正在超越這一點,著眼於避孕以外未滿足需求領域的女性健康,其中包括子宮內膜異位症、纖維化等對未來很重要的問題。

  • And then of course with women predominant in the aging population looking to identify particular needs for women across the spectrum of the life of women, and focusing in some significant opportunities at different stages of the life of women in multiple geographies.

    然後當然是在老齡化人口中占主導地位的女性希望在女性生活的各個方面確定女性的特殊需求,並關注多個地區女性生命不同階段的一些重要機會。

  • - Analyst

    - Analyst

  • Thank you very much.

    非常感謝。

  • Operator

    Operator

  • Randall Stanicky, Canaccord Genuity.

    Randall Stanicky,Canaccord Genuity。

  • - Analyst

    - Analyst

  • Great, thanks guys.

    太好了,謝謝大家。

  • Two very quick ones, one for Bill and then one probably for Jeremy.

    兩個非常快的,一個給 Bill,另一個可能給 Jeremy。

  • First, Bill, can you maybe just help us understand the US generics business and really more from a run rate perspective.

    首先,比爾,你能不能幫助我們了解美國的仿製藥業務,並從運行率的角度真正了解更多。

  • You had a great first half, some of those products are obviously seeing competition.

    你上半年表現出色,其中一些產品顯然面臨競爭。

  • How do we think about the base business there?

    我們如何看待那裡的基礎業務?

  • What are the big potential launches in '13 that can add a little to growth or clip what could be a tough comp?

    13 年有哪些重大的潛在發布可以增加一點增長或削減可能是艱難的競爭?

  • - President and CEO - Americas

    - President and CEO - Americas

  • Randall, thanks for the question.

    蘭德爾,謝謝你的提問。

  • You know, you heard the earlier data, right, that we launched nine products in the quarter with $8 billion of innovative value bringing us to roughly 20 products for the year worth about $23 billion in innovator value.

    你知道,你聽說過較早的數據,對吧,我們在本季度推出了 9 種產品,具有 80 億美元的創新價值,使我們今年大約有 20 種產品,價值約 230 億美元的創新者價值。

  • We have potential for as many as 10 more launches in the fourth quarter.

    我們有可能在第四季度再推出多達 10 次。

  • And so when you look at that, the potential for 30 launches in a year, that's a big year, probably -- and I was trying to think through as I looked at my records before the call, I don't remember a year that we've launched 30 products in a long, long time.

    因此,當你看到這一點時,一年內可能有 30 次發射,那可能是一個重要的一年——我在打電話之前查看我的記錄時試圖仔細考慮,我不記得那一年很長一段時間以來,我們推出了 30 種產品。

  • So when you really think about the comparable, I think you've got it right.

    所以當你真正考慮可比性時,我認為你是對的。

  • 2013 is a very strong year for launches, lots of them, some of them weren't as large as others, but great dollars coming in in 2012.

    2013 年是發布非常強勁的一年,其中有很多,其中一些沒有其他的那麼大,但 2012 年收入豐厚。

  • You don't have that same impact in 2013.

    你在 2013 年沒有同樣的影響。

  • When you look at 2013, do we have launches?

    當您回顧 2013 年時,我們有發布嗎?

  • Yes, we do.

    是的,我們有。

  • We have a number of them, and we can think of products such as [tizolamide] and a couple of others.

    我們有很多這樣的產品,我們可以想到 [替唑胺] 和其他一些產品。

  • And niacin that came in through the Barr acquisition, but absent that, nothing like we saw in 2012.

    以及通過收購 Barr 獲得的菸酸,但如果沒有,與我們在 2012 年看到的完全不同。

  • You do have an issue there that you really need to think broadly about.

    你確實有一個問題,你真的需要廣泛考慮。

  • When you think about the base business, we think the base business still remains very, very strong.

    當您考慮基礎業務時,我們認為基礎業務仍然非常非常強大。

  • It is a very commoditized market.

    這是一個非常商品化的市場。

  • You've got to be set up to handle that.

    你必須準備好處理這個問題。

  • But for the long run, generics with the advent of ACA are just going to continue to grow in the US, and you just have to be positioned to be able to handle that.

    但從長遠來看,隨著 ACA 的出現,仿製藥將在美國繼續增長,你只需要做好準備就可以處理這個問題。

  • - Analyst

    - Analyst

  • Is this a $4 billion or $4.5 billion sort of -- I know before a year ago you gave us sort of the plus or minus outlook on the business.

    這是 40 億美元還是 45 億美元——我知道一年前你給了我們對業務的正面或負面展望。

  • Is there a similar number that you can look to now, given the current conditions?

    考慮到當前情況,您現在可以查看類似的數字嗎?

  • - President and CEO - Americas

    - President and CEO - Americas

  • I think we've talked about this before.

    我想我們之前已經談過這個了。

  • This was -- it's a $4 billion-ish business.

    這是 - 這是一項價值 40 億美元的業務。

  • It goes up and down based on exclusivities.

    它根據排他性上下波動。

  • And so I think that's really the way you've got to think about this.

    所以我認為這真的是你必須考慮的方式。

  • There's that base that we just talked about that's strong, growing with ACA.

    我們剛才談到的那個基礎很強大,隨著 ACA 的發展而增長。

  • I think that's important.

    我認為這很重要。

  • But it's -- think of your base as around a $4 billion business, up and down.

    但它是 - 將您的基礎視為大約 40 億美元的業務,上下波動。

  • - Analyst

    - Analyst

  • Okay.

    好的。

  • And that's helpful.

    這很有幫助。

  • And then Jeremy, just a question, maybe a two-parter for you.

    然後 Jeremy,只是一個問題,也許是你的兩個部分。

  • Maybe I missed it.

    也許我錯過了。

  • Did you provide us the time line for when we're going to get 2013 guidance?

    您是否向我們提供了我們何時獲得 2013 年指南的時間表?

  • And then just specifically, there's been a lot of discussion around this, but is the Board actively considering boosting the dividend as one of the options that we could get on December 11th?

    然後具體來說,圍繞這個問題進行了很多討論,但董事會是否積極考慮將提高股息作為我們在 12 月 11 日可以獲得的選擇之一?

  • Thanks.

    謝謝。

  • - President and CEO

    - President and CEO

  • I think I made it pretty clear, we will provide formal guidance no later than December 11 this year.

    我想我已經說得很清楚了,我們將在今年 12 月 11 日之前提供正式指導。

  • And with regards to the Board's deliberations, I'm not prepared to go into it.

    關於董事會的審議,我不准備參與其中。

  • As I said to you, we have a very conscious approach to capital allocation and a very, very disciplined approach in addition to which we're conscious of the need to support shareholders in this process as well as build the Company.

    正如我對你說的,我們有一種非常有意識的資本配置方法和一種非常、非常有紀律的方法,此外我們意識到需要在這個過程中支持股東以及建設公司。

  • - Analyst

    - Analyst

  • Okay.

    好的。

  • Great.

    偉大的。

  • Thanks, guys.

    多謝你們。

  • Operator

    Operator

  • Ronny Gal, Sanford and Bernstein.

    羅尼加爾、桑福德和伯恩斯坦。

  • - Analyst

    - Analyst

  • Good morning, good afternoon, thank you very much for taking the questions.

    早上好,下午好,非常感謝您提出問題。

  • I've got two.

    我有兩個。

  • First, the rest of the world number, looked a little bit weaker if you just think about emerging markets.

    首先,如果你只考慮新興市場,世界其他地區的數字看起來有點弱。

  • Would you be able to break out for us a little bit the growth in Eastern Europe and Lat Am versus the more established markets?

    您能否為我們介紹一下東歐和拉丁美洲與更成熟市場的增長情況?

  • Second on the respiratory, it's a two-part.

    其次是呼吸,它分為兩部分。

  • First, it's good to hear about the Spiromax getting to bioequivalents and being able to submit in Europe.

    首先,很高興聽到 Spiromax 獲得生物等效性並能夠在歐洲提交。

  • Do you think you'll be in time for the expiry of the molecule patent in the United States?

    你認為你會及時趕上美國的分子專利到期嗎?

  • That is, mid-2015.

    也就是2015年年中。

  • And second, we've seen the mepolizumab study design for their Phase III, the subcutaneous multi-injection.

    其次,我們已經看到了 III 期皮下多次注射的美泊利單抗研究設計。

  • Would you be able to make reslizumab competitive against that product?

    你能讓reslizumab與那個產品競爭嗎?

  • - President and CEO

    - President and CEO

  • Why don't we start with Eyal.

    為什麼我們不從 Eyal 開始。

  • - CFO

    - CFO

  • Emerging markets, our emerging markets are part of the rest of the world category, but the rest of the world includes very mature markets like Israel, like Canada and emerging markets like Latin America, Eastern Europe, and what is emerging market for us is Japan.

    新興市場,我們的新興市場屬於世界其他地區的一部分,但世界其他地區包括非常成熟的市場,如以色列、加拿大和新興市場,如拉丁美洲、東歐,對我們來說新興市場是日本.

  • This quarter kind of balance each other, especially Canada had a very, very strong quarter last year, in the comparison and basically we are running on the same rate for the past three quarters, so this is not new, and has an impact on the entire group, including some foreign exchange impacts as well, but that was it.

    這個季度彼此平衡,尤其是加拿大去年有一個非常非常強勁的季度,相比之下,過去三個季度我們基本上以相同的速度運行,所以這不是新的,並且對整個集團,包括一些外匯影響,但僅此而已。

  • The emerging market products have done well there.

    新興市場產品在那裡表現良好。

  • - President and CEO

    - President and CEO

  • On the patent expiry, perhaps Rich or Michael you'd like to have an answer on that.

    關於專利到期,您可能希望 Rich 或 Michael 對此做出答复。

  • - President of Global R&D, Chief Scientific Officer

    - President of Global R&D, Chief Scientific Officer

  • Rich, do you want to comment?

    瑞奇,你要發表評論嗎?

  • - Group EVP, Chief Legal Officer, Company Secretary

    - Group EVP, Chief Legal Officer, Company Secretary

  • Could you repeat the question, please.

    請你重複這個問題好嗎?

  • - Analyst

    - Analyst

  • The question was do you expect to be in the US market with in mid-2015 when the compound patents expire for Advair?

    問題是,當 Advair 的化合物專利到期時,您是否預計會在 2015 年年中進入美國市場?

  • - President and CEO - Americas

    - President and CEO - Americas

  • I think the issue there, Ronnie, this is Bill Marth, is that the data that was generated for Europe is for Europe, and that data is not for the US.

    Ronnie,我認為這裡的問題是,為歐洲生成的數據是針對歐洲的,而不是針對美國的。

  • I think our position in respiratory in the US has been very clear for a long time, that the rules that allow us to get into the European market for generics with respect to respiratory are not the same as they are in the US.

    我認為我們在美國呼吸系統領域的立場長期以來一直非常明確,允許我們進入歐洲呼吸系統仿製藥市場的規則與美國不同。

  • We still believe very strongly that you're going to need clinical studies, and until l Michael or the FDA tell me differently we're going to be approaching it that way.

    我們仍然非常堅信您將需要進行臨床研究,並且直到邁克爾或 FDA 告訴我不同的方式,我們將以這種方式進行研究。

  • - Analyst

    - Analyst

  • I'm aware of that.

    我對此很清楚。

  • The device patent expires in 2016 but if you want to choose to go the 505(b)(2) way, you have an option of coming in middle 2015 with a composition of meta expire on the compounds.

    該設備專利將於 2016 年到期,但如果您想選擇 505(b)(2) 方式,您可以選擇在 2015 年年中使用元化合物的組合到期。

  • In the past you've kind of suggested that you will be able to come to the market with that formulation at that point, and then you weren't quite sure, and I'm kind of trying to get there, catch up, whether based on your recent results that expectation has changed?

    過去你曾建議你可以在那個時候帶著那個配方進入市場,然後你不太確定,我有點想到達那裡,趕上,是否根據您最近的結果,預期已經改變?

  • - President and CEO, Teva Europe

    - President and CEO, Teva Europe

  • I'd just comment on that.

    我只是對此發表評論。

  • We're very pleased with this bioequivalents result.

    我們對這一生物等效性結果感到非常滿意。

  • We're continuing in Europe and I'd say our US strategy is still being decided on and formulated.

    我們將繼續在歐洲開展業務,我想說我們的美國戰略仍在決定和製定中。

  • Let me just also comment on reslizumab, Ronny, that you asked about.

    讓我也評論一下你問過的reslizumab,Ronny。

  • Of course, the data from -- recent data validates this as a target I05 antagonist.

    當然,來自最近數據的數據證實這是一個目標 I05 拮抗劑。

  • We've of course in the middle of Phase III studies with our intravenous program, but we see the major application in the subQ.

    我們當然在 III 期研究中進行了靜脈注射計劃,但我們在 subQ 中看到了主要應用。

  • And we're pursuing reslizumab I'd say with great progress and intensity, both for IV, and in particular for subQ applications, and you'll hear more about that at the Investor Day.

    我們正在追求 reslizumab,我想說的是在 IV 方面,特別是在 subQ 應用方面,取得了很大的進展和強度,你會在投資者日聽到更多關於它的信息。

  • - Analyst

    - Analyst

  • Thank you very much.

    非常感謝。

  • Operator

    Operator

  • Thank you.

    謝謝你。

  • Dr. Levin, do you have any final remarks?

    萊文博士,您有什麼要說的嗎?

  • - President and CEO

    - President and CEO

  • Thank you very much.

    非常感謝。

  • I do appreciate everybody joining us this morning and for those elsewhere this afternoon.

    我非常感謝大家今天早上加入我們,也感謝今天下午其他地方的人。

  • Again, for those of you in the East Coast, our thoughts are with you.

    再一次,對於東海岸的你們,我們的心與你們同在。

  • I know it's really rough and I know it was particularly tough for some of you to get on this call, so my thanks to you.

    我知道這真的很艱難,我知道你們中的一些人特別難以接聽這個電話,所以我要感謝你們。

  • For the rest, we look forward to speaking with you later in the year, and certainly look forward to seeing those of you who can come and join us on December 11th.

    至於其他方面,我們期待在今年晚些時候與您交談,當然也期待在 12 月 11 日與您見面並加入我們。

  • Operator

    Operator

  • Thank you, ladies and gentlemen.

    謝謝你們,女士們,先生們。

  • This concludes today's conference.

    今天的會議到此結束。

  • You may listen to the playback by dialing 888-843-7419, and use the security code 33556091.

    您可以撥打888-843-7419收聽播放,使用安全碼33556091。

  • The playback will be available until November 8. Again, thank you for participating.

    回放將持續到 11 月 8 日。再次感謝您的參與。

  • You may now disconnect.

    您現在可以斷開連接。