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 to the Teva Pharmaceutical Q4 2013 conference call.
歡迎來到 Teva Pharmaceutical Q4 2013 電話會議。
My name is Dawn and I will the operator for today's call.
我叫 Dawn,我是今天電話的接線員。
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 will 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 will now turn the call over to Kevin Mannix, Vice President and Head of Global Investor Relations.
我現在將把電話轉給副總裁兼全球投資者關係主管 Kevin Mannix。
Kevin, you may begin.
凱文,你可以開始了。
Kevin Mannix - VP and Head of Global IR
Kevin Mannix - VP and Head of Global IR
Thank you, Dawn.
謝謝你,黎明。
Good morning and good afternoon, everyone.
大家早上好,下午好。
Thank you for joining our call to discuss Teva's fourth-quarter and full-year 2013 financial results.
感謝您加入我們討論 Teva 2013 年第四季度和全年財務業績的電話會議。
I'm joined today by our acting President and CEO, Eyal Desheh; our acting Chief Financial Officer, Kobi Altman; Doctor Michael Hayden, President, Global R&D and Chief Scientific Officer; Allan Oberman, President and CEO of Teva America Generics; Doctor Rob Koremans, President and CEO of Specialty Medicine; and Dipankar Bhattacharjee, President and CEO of Generics Europe.
今天,我們的代理總裁兼首席執行官 Eyal Desheh 加入了我的行列;我們的代理首席財務官 Kobi Altman;全球研發總裁兼首席科學官 Michael Hayden 博士; Teva America Generics 總裁兼首席執行官 Allan Oberman; Specialty Medicine 總裁兼首席執行官 Rob Koremans 博士; Generics Europe 總裁兼首席執行官 Dipankar Bhattacharjee。
Eyal will begin by providing an overview of the highlights from the quarter and full year, followed by Kobi, who will then provide additional details for our consolidated financial results.
Eyal 將首先概述本季度和全年的亮點,然後 Kobi 將提供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 which will run until approximately 9 AM Eastern time.
然後,我們將開始電話問答環節,一直持續到東部時間上午 9 點左右。
Before we start, I'd like to remind you that our discussion 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中的討論將包括前瞻性陳述。
Actual results could differ materially from those projected in the forward-looking statements.
實際結果可能與前瞻性陳述中預測的結果存在重大差異。
Factors that could cause actual results to differ are discussed in Teva's report on Form 20-F and Form 6-K.
Teva 的 20-F 表和 6-K 表報告中討論了可能導致實際結果不同的因素。
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, 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稅收影響。
These are amounts that we can not predict at this point.
這些是我們目前無法預測的數量。
We present these non-GAAP figures to show you how the management team and our Board of Directors look at our financial data.
我們提供這些非 GAAP 數據是為了向您展示管理團隊和我們的董事會如何看待我們的財務數據。
With that, I'll now turn the call over to Eyal.
有了這個,我現在將把電話轉給 Eyal。
Eyal, if you would please.
Eyal,如果你願意的話。
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
Thank you, Kevin.
謝謝你,凱文。
Good morning and good afternoon, everyone.
大家早上好,下午好。
We are pleased that you could join us today to discuss Teva's fourth-quarter and full-year 2013 results.
我們很高興您今天能加入我們討論 Teva 的第四季度和全年 2013 年業績。
I will use my time today to briefly discuss the results of the quarter and year as well as some of the achievements during 2013 before touching on key growth drivers for our future.
在談到我們未來的主要增長動力之前,我將利用今天的時間簡要討論本季度和年度的結果以及 2013 年取得的一些成就。
I will then turn the call over to our acting CFO, Kobi Altman, who will provide greater detail around our financial results.
然後我會將電話轉給我們的代理首席財務官 Kobi Altman,他將提供有關我們財務業績的更多細節。
Before I begin my review, I would like to remind our listeners that last month Teva announced that Erez Vigodman was appointed President and Chief Executive Officer of Teva, effective next Tuesday, February 11.
在我開始評論之前,我想提醒我們的聽眾,梯瓦上個月宣布任命 Erez Vigodman 為梯瓦總裁兼首席執行官,該任命將於 2 月 11 日下週二生效。
Since 2009 Erez has been a member of Teva's Board of Directors and he will remain on the Board while serving as CEO.
自 2009 年以來,埃雷茲一直是 Teva 的董事會成員,他將在擔任首席執行官期間繼續留在董事會。
Erez brings to Teva global leadership, business transformation experience, strong strategic expertise across multiple industries, and deep insights into global market dynamics.
Erez 為 Teva 帶來了全球領導地位、業務轉型經驗、跨多個行業的強大戰略專業知識以及對全球市場動態的深刻洞察。
Most importantly, he has an excellent understanding of Teva's pioneering spirit and the challenges we are facing.
最重要的是,他非常了解 Teva 的開拓精神和我們面臨的挑戰。
Under Erez's leadership, and together with the management team, we are all committed to delivering medicines and solutions to patients all over the world, and enhancing shareholders' value through operational improvements, portfolio optimization, gross margin expansion, strong cash flow generation, and business development activities.
在 Erez 的領導下,我們與管理團隊一起致力於為世界各地的患者提供藥品和解決方案,並通過運營改進、投資組合優化、毛利率擴張、強勁的現金流產生和業務提升股東價值發展活動。
Let me first briefly review the highlights of our financial results.
讓我首先簡要回顧一下我們財務業績的亮點。
Teva's revenues in the fourth quarter was $5.4 billion, a 3% increase compared to the fourth quarter of 2012.
梯瓦第四季度的收入為 54 億美元,與 2012 年第四季度相比增長了 3%。
Our fourth-quarter non-GAAP EPS was $1.42 per share, an increase of 8% over 2012.
我們第四季度的非 GAAP 每股收益為 1.42 美元,比 2012 年增長 8%。
Cash from operations before one-time settlement during the quarter was strong, reaching $1.7 billion with free cash flow of $1.1 billion before settlement.
本季度一次性結算前的運營現金強勁,達到 17 億美元,結算前自由現金流為 11 億美元。
On an annual basis, total revenue was flat compared to 2012 at $20.3 billion, while non-GAAP EPS was $5.01, down from $5.35 in 2012, following the anticipated loss or decline of several highly profitable products that were sold in the previous year, and an increase in sales and marketing and R&D as we continue to invest in our future.
按年度計算,總收入與 2012 年持平,為 203 億美元,而非 GAAP 每股收益為 5.01 美元,低於 2012 年的 5.35 美元,原因是前一年銷售的幾款高利潤產品預計出現虧損或下滑,以及隨著我們繼續投資於我們的未來,銷售和營銷以及研發的增加。
We also had very strong annual cash flow from operations of $5.1 billion and free cash flow of $3 billion before one-time settlements.
在一次性結算之前,我們還擁有 51 億美元的非常強勁的年度運營現金流和 30 億美元的自由現金流。
I am pleased to announce today that Teva's Board of Directors decided to increase the Company's quarterly dividend by 5%.
我今天很高興地宣布,Teva 董事會決定將公司的季度股息提高 5%。
This represents a dividend yield of about 3% annually.
這代表每年約 3% 的股息收益率。
Teva will review the possibility of further increasing dividend payments later this year, subject to the outcome of possible generic COPAXONE scenarios during 2014.
Teva 將在今年晚些時候審查進一步增加股息支付的可能性,這取決於 2014 年可能的通用 COPAXONE 情景的結果。
Now to further look at 2013.
現在進一步看看 2013 年。
We did manage to exceed the $20 billion mark in sales we had in our plan ending 2012.
我們確實設法超過了 2012 年底計劃中的 200 億美元銷售額。
However, we reached it with a very different mix of products and geographies than the year before.
然而,我們通過與前一年截然不同的產品和地域組合實現了這一目標。
During 2013 our product mix continued to change as greater revenues and profitability were derived from specialty medicines.
2013 年,我們的產品組合繼續發生變化,因為更多的收入和利潤來自專業藥物。
COPAXONE delivered another record performance against increasing oral competition, exceeding expectation again and maintaining its position as the number one MS therapy for patients globally.
COPAXONE 在日益激烈的口服競爭中取得了另一項創紀錄的表現,再次超出預期,並保持其作為全球 MS 患者首選療法的地位。
We are very pleased with last week's announcement that the US Food and Drug Administration approved Teva's supplemental new drug application for three times a week COPAXONE 40 milligram.
我們很高興上周宣布美國食品和藥物管理局批准了 Teva 每週三次 COPAXONE 40 毫克的補充新藥申請。
We began shipping products into distribution channels within 24 hours of approval.
我們在批准後 24 小時內開始將產品運送到分銷渠道。
The availability of new three times a week COPAXONE 40 milligram, which maintains the same efficacy and safety profile of daily COPAXONE is a welcome enhancement that offers patients 60% less frequent annual administration, which we believe will improve the over all patient experience.
每週 3 次新的 COPAXONE 40 毫克的可用性,它保持與每日 COPAXONE 相同的療效和安全性,這是一個受歡迎的改進,使患者每年給藥頻率減少 60%,我們相信這將改善所有患者的體驗。
In addition to COPAXONE we are continuing to drive future opportunities within the existing portfolio.
除了 COPAXONE,我們還在繼續推動現有產品組合中的未來機會。
After receiving orphan drug designation, the largest revenue-producing product in Teva's oncology portfolio, TREANDA, has extended its regulatory exclusivity to May 2016 for the indolent B-cell non-Hodgkin's leukemia.
在獲得孤兒藥稱號後,Teva 腫瘤產品組合中最大的創收產品 TREANDA 將其針對惰性 B 細胞非霍奇金白血病的監管獨占期延長至 2016 年 5 月。
We also expanded our global biological oncology portfolio with the launch of short-acting G-CSF in the US, GRANIX, and a long-acting G-CSF in Germany, LONQUEX.
我們還通過在美國推出短效 G-CSF GRANIX 和在德國推出長效 G-CSF LONQUEX 擴大了我們的全球生物腫瘤產品組合。
Revenues from generic medicines, including API, were $9.9 billion in 2013, a 5% decrease compared to 2012 mainly due to the termination of our generic Lipitor royalty agreement with Ranbaxy and lower sales of API.
2013 年來自包括 API 在內的仿製藥的收入為 99 億美元,與 2012 年相比下降 5%,這主要是由於我們與 Ranbaxy 的仿製藥立普妥特許權使用費協議的終止以及 API 銷售額的下降。
There were several highlights I would like to note.
我想指出幾個亮點。
During the year we launched 388 new generic products globally.
在這一年中,我們在全球推出了 388 種新的非專利產品。
In the United States we had 21 new launches during the year that contributed over $400 million to our top line.
在美國,我們這一年推出了 21 款新產品,為我們的收入貢獻了超過 4 億美元。
Around the globe we continue to focus on efficiency and cost reduction in our generic business, while focusing on value rather than volume.
在全球範圍內,我們繼續關注仿製藥業務的效率和成本降低,同時關注價值而非數量。
Turning to our OTC business and our joint venture with Procter & Gamble, PGT Healthcare.
轉向我們的 OTC 業務以及我們與寶潔公司的合資企業 PGT Healthcare。
We had exceptional results in 2013, as overall sales of the joint venture grew 15% to more than $1.5 billion following a very strong fourth quarter.
我們在 2013 年取得了非凡的業績,繼非常強勁的第四季度之後,合資企業的整體銷售額增長了 15%,超過 15 億美元。
Now looking towards our future, both short and long term, the opportunity lies in our global specialty and generic pipeline, our ability to reduce cost and a strategic approach to business development.
現在展望我們的短期和長期未來,機會在於我們的全球專業和通用管道、我們降低成本的能力以及業務發展的戰略方法。
I will begin with the pipeline.
我將從管道開始。
Preparation for new launches are continuing at full speed with excellent coordination between global, regional and local levels to ensure that we maximize the asset value.
新發布的準備工作正在全速進行,全球、區域和地方層面之間進行了出色的協調,以確保我們實現資產價值最大化。
In addition to the introduction of COPAXONE 40 milligram, we are preparing for several potential new product launches this year, including DuoResp, or BFC Spiromax in Europe; Adasuve and [Zicute] in the United States, as well as expanding our women's health portfolio with the anticipated launch of SEASONIQUE in Europe.
除了推出 40 毫克 COPAXONE 外,我們還在準備今年推出幾款潛在的新產品,包括歐洲的 DuoResp 或 BFC Spiromax; Adasuve 和 [Zicute] 在美國,並通過預期在歐洲推出 SEASONIQUE 來擴展我們的女性健康產品組合。
We are also continuing the launch of GRANIX, our short-acting G-CSF in the US and LONQUEX, our long-acting GCSF in Europe.
我們還將繼續在美國推出我們的短效 G-CSF GRANIX 和在歐洲推出我們的長效 GCSF LONQUEX。
2013 was a year our integrating and building Teva's global R&D organization, while still delivering strong performance in traditional and complex generic, specialty and NTE pipeline.
2013 年是我們整合和建設 Teva 全球研發組織的一年,同時在傳統和復雜的仿製藥、特種藥物和 NTE 管線中仍然表現強勁。
All was accomplished during this year.
一切都在這一年完成。
Generic R&D delivered 155 submissions in major markets.
Generic R&D 在主要市場提交了 155 份申請。
These submissions included 21 ANDAs in the United States, raising our total pipeline there to 133 pending ANDAs, representing $81 billion of brand value.
這些提交包括美國的 21 個 ANDA,使我們在那裡的總管道增加到 133 個未決 ANDA,代表了 810 億美元的品牌價值。
We believe that 51 one of those ANDAs are first-to-file opportunities representing $40 billion in brand value.
我們認為,其中 51 個 ANDA 是代表 400 億美元品牌價值的先申請機會。
In specialty pharma R&D had another eight submissions in major markets as part of 30 late-stage programs we are running, while our NTE approach yield 14 projects entering our development pipeline.
在專業製藥研發領域,作為我們正在運行的 30 個後期項目的一部分,在主要市場有另外 8 個提交,而我們的 NTE 方法產生了 14 個項目進入我們的開發管道。
During 2014 we will also reach important milestones in some of our specialty Phase III clinical programs, including reslizumab for acute asthma and custirsen for prostate cancer.
2014 年,我們的一些專業 III 期臨床項目也將達到重要的里程碑,包括治療急性哮喘的 reslizumab 和治療前列腺癌的 custirsen。
And depending on the outcome of the Phase III trials, we expect up to 10 specialty product submissions for regulatory approval, including one NTE.
根據 III 期試驗的結果,我們預計將提交多達 10 種特殊產品以供監管部門批准,其中包括一種 NTE。
While we continue to focus our efforts on our core R&D programs and go-to-market activities, we are also increasing organizational effectiveness to our cost reduction program to ensure Teva's growth and its role as a leader in the ever-changing pharmaceutical industry.
在我們繼續專注於我們的核心研發計劃和上市活動的同時,我們也在提高成本削減計劃的組織效率,以確保 Teva 的增長及其在不斷變化的製藥行業中的領導地位。
During 2013 we updated the market on our ongoing cost reduction program which includes approximately $2 billion in annual cost savings by the end of 2017, compared to the 2012 cost base.
2013 年,我們向市場更新了我們正在進行的成本削減計劃,其中包括與 2012 年成本基數相比,到 2017 年底每年可節省約 20 億美元的成本。
We estimate that $1 billion or 50% of the $2 billion annual cost savings will be realized by the end of 2014 and 70% by the end of 2015.
我們估計到 2014 年底將實現 10 億美元或 20 億美元年度成本節約的 50%,到 2015 年底將實現 70%。
The majority of the savings are expected to come from increased efficiencies in production, procurement and people.
預計大部分節省將來自生產、採購和人員效率的提高。
As we have disclosed, a minimum of $500 million at least will fall into the bottom line, while the remaining amount will be reinvested in the development and launch of our high-potential high-gross product primarily through R&D and sales and marketing expense increase.
正如我們所披露的那樣,至少有 5 億美元將落入底線,而剩餘的金額將主要通過研發和銷售和營銷費用的增加,再投資於開發和推出我們的高潛力高毛產品。
As well as to offset the increase in costs resulting from anticipated increases in volumes in our generic business.
以及抵消因我們仿製藥業務量的預期增加而導致的成本增加。
I want to assure you that the reinvestment of approximately $1 billion of the aforementioned target into our pipeline and sales and marketing will only happen if the opportunities have significant potential to be viable, durable and profitable.
我想向您保證,將上述目標中的大約 10 億美元再投資到我們的管道以及銷售和營銷中,只有在這些機會具有巨大的可行性、持久性和盈利潛力的情況下才會發生。
In the event that one or more of the pipeline opportunities fail to progress or do not fit the criteria just described, that will lead to additional money flowing through the bottom line.
如果一個或多個管道機會未能取得進展或不符合剛剛描述的標準,這將導致額外的資金流經底線。
Finally a word on business development.
最後談談業務發展。
Our strategy has and continues to emphasize the management of our business for long-term sustainable and profitable growth.
我們的戰略已經並將繼續強調我們的業務管理,以實現長期可持續和盈利的增長。
We intend to use business development as a key driver to build a robust generic and specialty pipeline and portfolio, while expanding and extending our geographical footprint.
我們打算將業務發展作為關鍵驅動力來建立強大的通用和專業管道和產品組合,同時擴大和擴展我們的地理足跡。
And we are open to any idea which will drive long-term value creation.
我們對任何能夠推動長期價值創造的想法持開放態度。
In any business development opportunity must meet our stringent criteria.
在任何業務發展機會中都必須符合我們嚴格的標準。
It must have strategic fit, support our leadership position, and be financially justified and accretive to earnings per share within a reasonable time.
它必須具有戰略契合性,支持我們的領導地位,並在合理的時間內在財務上合理並增加每股收益。
In closing, 2013 was an important year for Teva and its shareholders.
最後,2013 年對 Teva 及其股東來說是重要的一年。
Many seeds were planted to ensure our long-term success and prosperity.
種下了許多種子以確保我們的長期成功和繁榮。
2014 will be a pivotal year in terms of execution and further enhancement of our strategic direction.
2014年將是執行和進一步加強我們戰略方向的關鍵一年。
We move towards 2014 not only with the necessary determination to execute our plan, but also with firm belief that the important choices we made in the past year are crucial in our journey to a successful future.
邁向 2014 年,我們不僅堅定地執行我們的計劃,而且堅信我們在過去一年做出的重要選擇對於我們走向成功的未來至關重要。
I will now turn the call over to Kobi who will provide additional details about our financial results for 2013.
我現在將電話轉給 Kobi,他將提供有關我們 2013 年財務業績的更多詳細信息。
Kobi, please go ahead.
科比,請繼續。
Kobi Altman - Acting CFO
Kobi Altman - Acting CFO
Thank you, Eyal, and good day, everyone.
謝謝你,Eyal,祝大家有美好的一天。
I'm happy you could join us today to review our financial results for the fourth quarter and full-year 2013.
很高興您今天能加入我們,回顧我們 2013 年第四季度和全年的財務業績。
We are reporting today strong results for the fourth quarter, which ends a year largely in line with expectations for Teva, despite some tough comparisons to 2012.
我們今天報告了第四季度的強勁業績,儘管與 2012 年進行了一些艱難的比較,但第四季度的業績基本符合 Teva 的預期。
Net revenues for the year were $20.3 billion, flat compared to 2012, in spite of the anticipated loss of exclusivity on Provigil and certain generic products, primarily atorvastatin, in 2012.
這一年的淨收入為 203 億美元,與 2012 年相比持平,儘管預計 2012 年 Provigil 和某些仿製藥(主要是阿托伐他汀)的專營權將喪失。
This was achieved by strong performance in 2013 of many of our businesses, primarily specialty medicine led by COPAXONE, our generic business and our OTC business.
這得益於我們許多業務在 2013 年的強勁表現,主要是 COPAXONE 領導的專科藥物、我們的仿製藥業務和非處方藥業務。
Non-GAAP EPS for 2013 was slightly above the midpoint to follow guidance at $5.01, compared to the $5.35 in 2012, a decrease that mainly resulted from the loss of exclusivity for the high margin products that I just mentioned, partially offset by the good performance in other parts of the business.
與 2012 年的 5.35 美元相比,2013 年的非 GAAP 每股收益略高於遵循指引的中點 5.01 美元,下降的主要原因是失去了我剛才提到的高利潤產品的獨家經營權,部分被良好的業績所抵消在業務的其他部分。
For the fourth quarter of 2013 we are reporting today a solid $5.4 billion net revenue and $1.42 in non-GAAP EPS, an increase of 3% and 8%, respectively, compared to the fourth quarter of 2012.
我們今天公佈的 2013 年第四季度淨收入和非美國通用會計準則每股收益分別為 54 億美元和 1.42 美元,分別比 2012 年第四季度增長 3% 和 8%。
During 2013 we have been working hard to transform Teva, to deliver on strategy laid out for the Company and to build a more efficient effective organization.
2013 年,我們一直在努力改造 Teva,以實現為公司製定的戰略,並建立一個更高效的組織。
We are making strong progress on all of these fronts and I will share some of it with you shortly.
我們在所有這些方面都取得了長足的進步,我將很快與您分享其中的一些進展。
Before I delve further into the results of the year and the quarter, I would like to touch on three important issues.
在我進一步研究本年度和本季度的結果之前,我想談談三個重要問題。
First, starting this quarter, Teva will report two separate segments in its financial statement.
首先,從本季度開始,Teva 將在其財務報表中報告兩個獨立的部門。
Our two segments are generics and specialty.
我們的兩個部分是仿製藥和專業。
While we will maintain the level of granularity of financial information that we provided, there may be some changes in our previous reporting structure.
雖然我們將保持我們提供的財務信息的粒度級別,但我們以前的報告結構可能會發生一些變化。
We encourage you to review our full financial statements that we will file in a few days to familiarize yourself with them.
我們鼓勵您查看我們將在幾天內提交的完整財務報表,以熟悉它們。
Second, in the fourth quarter we took relatively high one-time charges totalling $825 million after-tax which we adjusted in arriving at our non-GAAP results.
其次,在第四季度,我們採取了相對較高的一次性費用,總計 8.25 億美元的稅後費用,我們根據非 GAAP 業績進行了調整。
These charges, including permits of $329 million, mostly related to plant closure, portfolio optimization, write-off of IP R&D and investment write-off.
這些費用,包括 3.29 億美元的許可證,主要與工廠關閉、投資組合優化、知識產權研發註銷和投資註銷有關。
Furthermore, these charges include amortization of certain intangible assets totaling $330 million, restructuring expenses totaling $104 million related to our ongoing cost reduction program.
此外,這些費用包括總計 3.3 億美元的某些無形資產攤銷,以及與我們正在進行的成本削減計劃相關的總計 1.04 億美元的重組費用。
In addition are smaller items.
此外還有較小的物品。
Accordingly, our non-GAAP net income and EPS for the quarter are adjusted to exclude these and certain other items outlined in our press release.
因此,我們調整了本季度的非 GAAP 淨收入和每股收益,以排除這些以及我們新聞稿中概述的某些其他項目。
Third, exchange rate differences continue to negatively affect our results this quarter and for the full year 2013.
第三,匯率差異繼續對我們本季度和 2013 年全年的業績產生負面影響。
Compared to the respective period in 2012, these differences reduce our revenue by $49 million this quarter and $166 million for the year, and our operating profit by $45 million this quarter and $129 million for the year.
與 2012 年同期相比,這些差異使我們本季度的收入減少了 4900 萬美元,全年減少了 1.66 億美元,本季度的營業利潤減少了 4500 萬美元,全年減少了 1.29 億美元。
The reduction in revenues resulted from the weakening of certain currencies, primarily the Japanese yen and Russian ruble, relative to the US dollar.
收入減少是由於某些貨幣相對於美元走弱,主要是日元和俄羅斯盧布。
The major impact on our operating income was caused by the strengthening of the Israeli shekel against all currencies.
對我們營業收入的主要影響是以色列謝克爾兌所有貨幣走強所致。
Let me move on now to discuss some highlights of our financial performance by segment.
現在讓我繼續討論我們按部門劃分的財務業績的一些亮點。
Revenue from generic medicine, including API, were $9.9 billion in 2013, a 3% decrease in local currency terms compared to 2012.
2013 年,包括原料藥在內的仿製藥收入為 99 億美元,按當地貨幣計算比 2012 年下降 3%。
This decrease is mainly due to the termination of the agreement concerning atorvastatin back in 2012 and lower API sales.
這一下降主要是由於 2012 年阿托伐他汀協議的終止以及 API 銷售額的下降。
Despite the decrease in sales, we continue to strengthen our value market share in the US and key markets in Europe.
儘管銷售額下降,但我們繼續加強我們在美國和歐洲主要市場的價值市場份額。
During the year we launched 21 generic products in the US, 7 of them as first-to-file, or process-to-file, and 367 new generic products outside the US.
在這一年中,我們在美國推出了 21 種仿製藥,其中 7 種是首次申請或申請過程,在美國以外推出了 367 種新的仿製藥。
In the fourth quarter generic medicine, including API sales, were $2.7 billion, a 1% increase over the fourth quarter of 2012.
第四季度,包括原料藥在內的仿製藥銷售額為 27 億美元,比 2012 年第四季度增長 1%。
In our specialty segment we had a record year, with sales of $8.4 billion dollars, an increase of 3% compared to 2012.
在我們的專業領域,我們創造了創紀錄的一年,銷售額達到 84 億美元,與 2012 年相比增長了 3%。
With the exception of the sleep disorder business, where we experienced the anticipated loss of exclusivity on PROVIGIL in 2012, several of our specialty products increased year-over-year in all therapeutic areas and in most geographies.
除了睡眠障礙業務(我們在 2012 年預計會失去 PROVIGIL 的獨占權)外,我們的一些專業產品在所有治療領域和大多數地區都同比增長。
Revenue from COPAXONE in 2013 were at an all-time high of $4.3 billion, an increase of 8% compared to 2012.
2013 年 COPAXONE 的收入創歷史新高,達到 43 億美元,比 2012 年增長 8%。
Despite multiple competitors entering the MS space, COPAXONE continues to be the leading MS therapy in the US and globally.
儘管有多個競爭對手進入 MS 領域,但 COPAXONE 仍然是美國和全球領先的 MS 療法。
And it's maintaining its total prescription and new prescription leadership in the US.
並且它在美國保持其總處方和新處方的領導地位。
Finally for our OTC business, where our joint venture with P&G, PGT Healthcare, set another record year in 2013, improving its base business, driving sales force impact and benefiting from favorable pricing trends.
最後,對於我們的非處方藥業務,我們與寶潔的合資企業 PGT Healthcare 在 2013 年再創新高,改善了基礎業務,推動了銷售隊伍的影響,並受益於有利的定價趨勢。
For the full year, Teva recorded revenue of $1.165 million,(sic-see press release "$1.165 billion") a significant increase of 26%, net of foreign exchange impact, compared to 2012 with gains in all regions.
全年,Teva 的收入為 116.5 萬美元(原文見新聞稿“11.65 億美元”),扣除外匯影響後,與 2012 年相比大幅增長 26%,在所有地區均有增長。
We are very pleased with how PGT Healthcare is progressing and together with our partners at P&G are planning for its continued growth.
我們對 PGT Healthcare 的進展感到非常高興,並與我們在 P&G 的合作夥伴一起計劃其持續增長。
Turning next to profit margin and operating expenses.
接下來轉向利潤率和運營費用。
Non-GAAP gross profit in 2013 was $11.9 billion or 58.6% of revenue, a decrease of $0.2 billion or 0.8% compared to 2012.
2013 年非美國通用會計準則毛利潤為 119 億美元,佔收入的 58.6%,比 2012 年減少 2 億美元或 0.8%。
This decrease was mainly the result of lower revenues of PROVIGIL, which lost its exclusivity, as well as the reduced revenue from additional exclusive generic products, mainly atorvastatin.
這一下降主要是由於 PROVIGIL 的收入減少,後者失去了獨占性,以及其他獨家仿製藥產品(主要是阿托伐他汀)的收入減少。
These were partially offset by more profitable product mix mainly in the US generic business, and higher COPAXONE revenue, as well as early contribution of our cost reduction program.
這些被主要在美國仿製藥業務中更有利可圖的產品組合、更高的 COPAXONE 收入以及我們的成本削減計劃的早期貢獻所部分抵消。
We are very pleased with the progress that our global R&D organization is making on all fronts, specifically in developing our NTE program and broadening our complex generic portfolio.
我們對我們的全球研發組織在各個方面取得的進展感到非常高興,特別是在開發我們的 NTE 計劃和擴大我們複雜的仿製藥產品組合方面。
As a reflection of that progress, our non-GAAP net research and development expenses increased in 2013 to $1.4 billion, or 7% of revenues, compared to $1.3 billion or 6.3% of revenues in 2012.
作為這一進步的反映,我們的非 GAAP 淨研發費用在 2013 年增加到 14 億美元,佔收入的 7%,而 2012 年為 13 億美元,佔收入的 6.3%。
We experienced a similar increase quarter over quarter as well.
我們也經歷了類似的季度環比增長。
Throughout 2013 we increased our selling and marketing expenses to support five specialty launches in our growing OTC business, as well as prepare for as many as six potential specialty launches in 2014, including the recently launched COPAXONE 40 milligram.
在整個 2013 年,我們增加了銷售和營銷費用,以支持我們不斷增長的 OTC 業務中的五項專科藥物上市,並為 2014 年多達六項潛在專科藥物的上市做準備,包括最近推出的 COPAXONE 40 毫克。
For the full year our non-GAAP selling and marketing expenses totaled approximately $4 billion, or 19.9% of revenue compared to $3.8 billion or 18.9% of revenue in 2012.
全年,我們的非 GAAP 銷售和營銷費用總計約為 40 億美元,佔收入的 19.9%,而 2012 年為 38 億美元,佔收入的 18.9%。
In the fourth quarter these expenses totaled $1.1 billion compared to approximately $1 billion in the first quarter of 2012.
與 2012 年第一季度的大約 10 億美元相比,第四季度這些費用總計 11 億美元。
Our non-GAAP operating profit in 2013 was $5.2 billion compared to $5.7 billion in 2012.
我們 2013 年的非美國通用會計準則營業利潤為 52 億美元,而 2012 年為 57 億美元。
This 9% decline is mainly the result of slower sales of exclusive generic and specialty products mainly PROVIGIL, coupled with higher R&D and sales and marketing expenses.
這 9% 的下降主要是由於獨家通用和專業產品(主要是 PROVIGIL)的銷售放緩,加上研發和銷售和營銷費用增加。
For the fourth quarter operating profit totaled $1.36 billion, an increase of 1% compared to last year.
第四季度營業利潤總計 13.6 億美元,比去年同期增長 1%。
For the full-year 2013 the overall split of operating profit before G&A expenses between our main lines of business is global generics 29%, MS 50%, other specialty brands 19%, OTC and other businesses 2%.
對於 2013 年全年,我們主要業務線之間 G&A 費用前營業利潤的總體分配為全球仿製藥 29%、MS 50%、其他專業品牌 19%、OTC 和其他業務 2%。
Turning now to tax.
現在轉向稅收。
For the full-year 2013, our annual tax rate on a non-GAAP basis was 12.8% compared to 12.3% in 2012.
對於 2013 年全年,我們按非公認會計原則計算的年稅率為 12.8%,而 2012 年為 12.3%。
Our annual tax rate for the year was lower than we initially projected due to several items in 2013 that were not initially forecast, at least not at their prevailing magnitude, which reduced our tax rate for the year, but will not repeat in future years.
由於 2013 年的幾個項目最初沒有預測,至少沒有達到目前的規模,我們今年的年度稅率低於我們最初預測,這降低了我們當年的稅率,但在未來幾年不會重複。
In particular, our tax rate in Israel on approved enterprises increased from 6% to 9%, resulting in a one-time increase in the value of our Israeli tax assets.
特別是我們在以色列對獲批企業的稅率從6%提高到9%,使我們在以色列的稅收資產價值一次性增加。
During 2013 we have been executing rigorously on our cost reduction program in many areas of the Company.
2013 年,我們一直在公司的許多領域嚴格執行成本削減計劃。
We are currently in process of implementing multiple projects and initiatives in procurement, production and supply chain, people and processes, commercial excellence, R&D and many other areas.
我們目前正在採購、生產和供應鏈、人員和流程、商業卓越、研發和許多其他領域實施多個項目和計劃。
All these ongoing projects resulted in an aggregate reduction of our cost base by $426 million compared to the baseline at 2012 year end, and our total headcount was reduced by approximately 1,000 employees.
與 2012 年底的基線相比,所有這些正在進行的項目使我們的成本基數總共減少了 4.26 億美元,我們的總員工人數減少了大約 1,000 名。
We remain strongly committed to delivering on our cost reduction program, and are working towards achieving the $1 billion cumulative cost reduction targets by the end of 2014.
我們仍然堅定地致力於實施我們的成本削減計劃,並致力於在 2014 年底之前實現 10 億美元的累計成本削減目標。
Teva continues to generate solid cash flow by strengthening its underlying business and focusing on the right metrics, such as reducing working capital.
Teva 通過加強其基礎業務並專注於正確的指標(例如減少營運資本),繼續產生穩健的現金流。
In the fourth quarter cash flow from operations and free cash flow, excluding the one-time payments of certain legal and tax settlements this quarter, were approximately $1.7 billion and $1.1 billion, an increase of 5% and 4%, respectively, compared to the fourth quarter of 2012.
第四季度運營現金流和自由現金流(不包括本季度某些法律和稅收結算的一次性付款)約為 17 億美元和 11 億美元,分別比去年同期增長 5% 和 4% 2012 年第四季度。
For the full year 2013 cash flow from operations and free cash flow, excluding the settlements I mentioned, were a solid $5 billion and $3 billion, an increase of 9% and 8%, respectively, compared to 2012.
2013 年全年運營現金流和自由現金流(不包括我提到的結算)分別為 50 億美元和 30 億美元,與 2012 年相比分別增長 9% 和 8%。
During the fourth quarter we did not repurchase any shares.
在第四季度,我們沒有回購任何股票。
During the entire 2013 we repurchased 12.8 million shares for approximately $500 million as part of the $3 billion share repurchase plan that was authorized in December 2011.
在整個 2013 年,作為 2011 年 12 月批准的 30 億美元股票回購計劃的一部分,我們以大約 5 億美元的價格回購了 1280 萬股股票。
Together with dividends paid, we have returned approximately $1.6 billion in cash to our shareholders this year representing 49% of our cash flow from operations, after the payment of certain legal and tax settlements this year, or 69% of our free cash flow before dividends but after the payment of those settlements.
連同支付的股息,我們今年向股東返還了約 16 億美元的現金,占我們今年支付某些法律和稅收結算後運營現金流的 49%,或占股息前自由現金流的 69%但在支付這些和解金之後。
I believe all of these measures, coupled with the dividend increase we announced, strongly demonstrate the ongoing commitment of Teva and its Board to reward and return cash to our shareholders.
我相信所有這些措施,加上我們宣布的股息增加,有力地表明了 Teva 及其董事會對獎勵和向股東返還現金的持續承諾。
Looking ahead now to 2014, we are reiterating today the full-year guidance we gave on December 10.
現在展望 2014 年,我們今天重申我們在 12 月 10 日給出的全年指引。
We have started the year on the right foot with the [rollout] of COPAXONE 40 milligram and the appointment of Erez Vigodman as our new President and CEO, and are very excited of the prospects we see ahead of Teva this year.
隨著 [推出] COPAXONE 40 毫克和任命 Erez Vigodman 為我們的新總裁兼首席執行官,我們在今年開局良好,我們對今年在 Teva 之前看到的前景感到非常興奮。
We will of course continue to update you on the progress we make on all fronts throughout the year.
我們當然會繼續向您通報我們全年在各個方面取得的進展。
This concludes my prepared remarks.
我準備好的發言到此結束。
Thank you all for your time and attention.
謝謝大家的時間和關注。
I would now like to open the call for Q&A.
我現在想打開問答環節。
Operator
Operator
(Operator Instructions)
(操作員說明)
Ken Cacciatore, Cowen and Company.
Ken Cacciatore, Cowen and Company。
Ken Cacciatore - Analyst
Ken Cacciatore - Analyst
Thanks for taking the question.
感謝您提出問題。
First question I had was on the cost.
我的第一個問題是費用。
Wanted to clarify.
想澄清一下。
It sounds as if $500 million definitively gets to the bottom line next year, and you are going to have flexibility depending on other opportunities.
聽起來好像 5 億美元肯定會在明年達到底線,並且您將根據其他機會獲得靈活性。
I was wondering, is some of the potential cost savings going to be predicated on your retention of COPAXONE if there is a generic launch?
我想知道,如果有仿製藥上市,一些潛在的成本節省是否取決於您保留 COPAXONE?
I wanted to understand if there is any flexibility around that.
我想了解是否有任何靈活性。
Also wanted to understand if you were thinking or contemplating about limiting the once-daily COPAXONE for the three-times-daily, i.e.
還想了解您是否正在考慮或考慮將每日一次的 COPAXONE 限制為每日三次,即
force the conversion or try to accelerate the conversion, how you think about that.
強制轉換或嘗試加速轉換,你怎麼想的。
Thanks very much.
非常感謝。
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
Hi, Ken, it's Eyal.
嗨,肯,我是埃亞爾。
Let me take the first one and Rob will take the second one on the three times with the COPAXONE.
讓我拿第一個,Rob 將用 COPAXONE 拿第三個。
Regarding expenses, the minimum that we see flowing to the bottom line over the program is $500 million.
關於支出,我們認為流向該計劃底線的最低金額為 5 億美元。
It could be more.
可能更多。
I believe that, you face reality, the generic introduction of COPAXONE will force us to sharpen our thoughts on [copert] efficiency again and again and again.
我相信,面對現實,COPAXONE 的仿製藥的推出將迫使我們一次又一次地提高對[copert]效率的思考。
There's no doubt about it, but right now I think we are running pretty well with the cost reduction program.
毫無疑問,但現在我認為我們在降低成本計劃方面進展順利。
2013 was not supposed to be a meaningful year.
2013 年本不應該是有意義的一年。
We've done a little better.
我們做得更好了。
We reduced our headcount by 1,000 employees during the year.
我們在這一年中裁員了 1,000 名員工。
By tightening the belt and our definitely not going to spend anything we judge unnecessary to build value.
通過勒緊褲腰帶,我們絕對不會花費任何我們認為不必要的東西來創造價值。
Rob, do you want to take the three-times-a-week?
羅布,你想每週上三次嗎?
Rob Koremans - President and CEO of Specialty Medicine
Rob Koremans - President and CEO of Specialty Medicine
Yes, pleasure.
是的,快樂。
First of all, we are delighted that we have the registration for the three-times-weekly 40.
首先,我們很高興每週 3 次 40 的註冊。
Within 24 hours after receiving it, we got the products to pharmacies in the US and that's also quite an accomplishment.
收到後24小時內,我們就把產品送到了美國的藥店,這也是一個了不起的成就。
We have done everything that we can to increase the nursing staff and get the message out to patients or doctors, but ultimately they decide whether they want to use the three-times-weekly 40 or continue to use our 20.
我們已盡一切努力增加護理人員,並向患者或醫生傳達信息,但最終他們決定是要使用每週 3 次的 40 次還是繼續使用我們的 20 次。
What we know from market research though is very encouraging.
不過,我們從市場研究中了解到的情況非常令人鼓舞。
We just confirmed our previous guidance of anywhere between 30% to 50% of the patients will switch by the end of this year to the three-times-weekly 40.
我們剛剛確認,我們之前對 30% 至 50% 患者的指導將在今年年底前轉變為每週 3 次 40 次。
But we definitely have no plans to force a conversion.
但我們絕對沒有強制轉換的計劃。
That's not how we approach the business.
這不是我們處理業務的方式。
Or limit the 20 in any way other at this moment.
或者此時以其他任何方式限制 20。
Ken Cacciatore - Analyst
Ken Cacciatore - Analyst
Thank you.
謝謝你。
Operator
Operator
Liav Abraham, Citi.
利亞夫·亞伯拉罕,花旗銀行。
Liav Abraham - Analyst
Liav Abraham - Analyst
Good morning.
早上好。
A couple of questions please.
請問幾個問題。
First, on your US generics business, you mentioned, I think, seven incremental first-to-file opportunities in 2013.
首先,關於您的美國仿製藥業務,我認為您在 2013 年提到了七個遞增的先申請機會。
It seems as though this number is a little low compared to some of your peers.
與您的一些同行相比,這個數字似乎有點低。
You've stressed in the past that the strategy for your generics division is to focus on first-to-file opportunities.
您過去曾強調,您的仿製藥部門的戰略是關注先申請機會。
Can you comment on what you're doing to maximize the strategy going forward?
你能評論一下你正在做什麼來最大化未來的戰略嗎?
Following on from this, a question on the structure of your R&D organization.
接下來是關於您的研發組織結構的問題。
I understand that you've globalized this organization with generics and branded R&D under the same umbrella.
據我了解,您已將仿製藥和品牌研發置於同一保護傘下,使該組織全球化。
Can you comment on the merits of this strategy?
你能評論一下這個策略的優點嗎?
Do you think that there is sufficient focus on generics R&D within the organization, given your increased focus on branded products, NTEs and your branded portfolio, generally?
考慮到您對品牌產品、NTE 和您的品牌產品組合的關注度越來越高,您認為組織內部對仿製藥研發的關注度是否足夠?
Thank you.
謝謝你。
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
Allan, can you please take the first one?
艾倫,你能拿第一個嗎?
And Michael will take the second.
第二個是邁克爾。
Allan Oberman - President and CEO of Teva America Generics
Allan Oberman - President and CEO of Teva America Generics
Sure.
當然。
Thank you for the question.
感謝你的提問。
If we think of the US generics business, you are right.
如果我們想到美國的仿製藥行業,你是對的。
We did launch 21 products this year, more than anyone else.
今年我們確實推出了 21 款產品,比任何人都多。
In those 21 products, seven of those were first-to-file.
在這 21 種產品中,有 7 種是在先申請的。
To preempt, perhaps, the submission question, we submitted 21 products.
也許是為了搶先提交問題,我們提交了 21 種產品。
And of the 21 products we anticipate about 8 of them will be first-to-file.
在我們預計的 21 種產品中,大約有 8 種將首先申請。
We won't know until, clearly, we hear from the FDA.
直到我們清楚地聽到 FDA 的消息,我們才會知道。
As we look to the future, we see that percentage ramping up to about 50% of our US submissions will be -- we anticipate being in the first-to-file category.
展望未來,我們看到在美國提交的申請中所佔比例將上升至 50% 左右——我們預計將屬於先申請類別。
So we're very optimistic about our business and the submissions in the launches that will come from that.
因此,我們對我們的業務以及由此產生的發布中的提交非常樂觀。
We do know there's been some recent data published by some of our competitors that are suggesting they have stronger first-to-file positions.
我們確實知道我們的一些競爭對手最近發布了一些數據,這些數據表明他們擁有更強的先申請地位。
A couple of comments on that.
對此有幾點評論。
First, the data that was presented that we saw, combined internal company data of that company with publicly available company data of their competitors, including ourselves.
首先,我們看到的呈現的數據結合了該公司的內部公司數據和他們競爭對手(包括我們自己)的公開可用公司數據。
And therefore, in the Teva numbers that were presented, a severely under-calculated the number of first-to-file products that we anticipate getting within our portfolio as we look to both historically and to the future.
因此,在提供的 Teva 數字中,我們預計從歷史和未來來看,我們預計在我們的產品組合中獲得的首次申請產品的數量被嚴重低估。
And then finally, to reinforce the value focus, we've looked through the information that was disclosed in the Activis presentation.
最後,為了加強對價值的關注,我們查看了 Activis 演示文稿中披露的信息。
Of the 11 products that were disclosed, let's say that two-thirds to three-quarters of them represent a very small portion of the value creation that they articulated.
在披露的 11 種產品中,假設其中三分之二到四分之三隻代表了它們所表達的價值創造的一小部分。
20% to 25% of the products are where the major value creation comes from.
20% 到 25% 的產品是主要價值創造的來源。
We are in a race with Activis on those products.
我們在這些產品上與 Activis 競爭。
I think we do have to admit that Activis beat us on two of those, but that doesn't mean that we won't continue to win on others.
我認為我們必須承認 Activis 在其中兩個方面擊敗了我們,但這並不意味著我們不會繼續在其他方面獲勝。
Our focus is to, again, look at those high-value first-to-file complex generics, devote over 50% of our R&D investment towards those products and leverage those for value creation.
我們的重點再次是關注那些高價值的先申請複雜仿製藥,將我們 50% 以上的研發投資投入到這些產品上,並利用這些產品創造價值。
And with that, I'll turn it over to Michael to describe how well we're doing in that area.
有了這個,我會把它交給邁克爾來描述我們在那個領域的表現。
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
Thank you, Liav, for your question.
謝謝你,Liav,你的問題。
With regard to the emphasis on generics, I would say we continue to have a sharp focus with regard to our generics R&D portfolio.
關於對仿製藥的重視,我想說我們將繼續高度關注我們的仿製藥研發組合。
The major focus over the last few years and further enhancing 2014, will be to build up our complex technology portfolio.
過去幾年和 2014 年進一步加強的主要重點將是建立我們複雜的技術組合。
We are investing significantly in that particular area to look to having our complex generic products becoming a very significant part of our submissions in the near future.
我們正在該特定領域進行大量投資,希望在不久的將來讓我們複雜的通用產品成為我們提交的非常重要的部分。
The integration between the generic and the specialty organizations has been remarkably successful, tremendous synergies, unexpected and expected.
通用和專業組織之間的整合非常成功,產生了巨大的協同效應,既出乎意料又意料之中。
Of course the major bonus has been the integration with the development of the NTEs.
當然,主要的好處是與 NTE 的發展相結合。
As you know, we had 14 NTEs last year, and looking forward to another 10 this year of the NTEs.
如您所知,我們去年有 14 個 NTE,並期待今年再有 10 個 NTE。
We will have significant -- we'll have our first NTE filed this year and eight of them coming through submission in the next three years.
我們將有重要的 - 我們將在今年提交我們的第一個 NTE,其中八個將在未來三年內提交。
This reflects a combined integration between the skills, both in the generic business and the branded business.
這反映了通用業務和品牌業務中技能之間的綜合整合。
For example, in terms of our integration, the good example is the integration of our devices portfolio and our devices technology, where of course this serving both our generics and specialty business.
例如,就我們的整合而言,一個很好的例子是我們的設備組合和我們的設備技術的整合,這當然服務於我們的仿製藥和專業業務。
This has proven to be a tremendously strengthened, synergized and of great use to both research efforts.
事實證明,這極大地加強了協同作用,對兩項研究工作都有很大幫助。
Liav Abraham - Analyst
Liav Abraham - Analyst
Thanks very much.
非常感謝。
Operator
Operator
David Maris, BMO Capital Markets.
BMO 資本市場的 David Maris。
David Maris - Analyst
David Maris - Analyst
Good morning, Eyal.
早上好,埃亞爾。
A couple of questions.
幾個問題。
First, some investors are concerned that when a new CEO joins, they often reset guidance.
首先,一些投資者擔心,當新 CEO 加入時,他們通常會重新設定指引。
But is it fair to say that since the Company's reiterating its guidance now and the new CEO is already on the Board, that that is something that's unlikely or not going to happen when he officially takes the role of CEO?
但可以公平地說,既然公司現在重申了其指導方針,而且新任首席執行官已經在董事會任職,那麼當他正式擔任首席執行官一職時,這種情況不太可能或不會發生嗎?
Separately, on the three-times-a-week availability, there seems to be a little bit of confusion.
另外,關於每週三次的可用性,似乎有點混亂。
Is that widely available as of right now in the US?
目前在美國廣泛使用嗎?
Or will it be in the next few weeks?
還是會在接下來的幾週內發生?
Thank you.
謝謝你。
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
Good morning, David.
早上好,大衛。
Thanks for the question.
謝謝你的問題。
I'll take the first one.
我要第一個。
We reiterated our guidance.
我們重申了我們的指導意見。
That's the best information that we have available and we analyze it on an ongoing basis.
這是我們現有的最佳信息,我們會持續對其進行分析。
The habit of new CEOs to reset hopefully is not going to repeat in this case.
在這種情況下,希望新 CEO 重新設置的習慣不會重演。
And other than that, as of course he'll be leading this call next quarter, and I hope many will have a chance to meet him before that.
除此之外,他當然會在下個季度主持這次電話會議,我希望在此之前很多人都有機會見到他。
Rob Koremans - President and CEO of Specialty Medicine
Rob Koremans - President and CEO of Specialty Medicine
Thanks for the question.
謝謝你的問題。
Like I said, we launched COPAXONE three-times-weekly.
正如我所說,我們每週推出三次 COPAXONE。
Within 24 hours in the US came into the first pharmacies, but it's widely available now.
24 小時內在美國進入第一家藥店,但現在已廣泛使用。
So I'm very pleased to take away that confusion.
所以我很高興消除這種困惑。
It's a fantastic product that many patients can benefit from now everywhere the US.
這是一個了不起的產品,現在美國各地的許多患者都可以從中受益。
David Maris - Analyst
David Maris - Analyst
And as a follow-up, Eyal, when we got together in Israel last week, we talked a little bit about the likelihood of one generic versus two generics versus no generics.
作為後續行動,Eyal,當我們上週在以色列聚會時,我們討論了一種仿製藥、兩種仿製藥和沒有仿製藥的可能性。
Is it still Teva's believe that there are very critical and credible reasons that generics shouldn't be approved for COPAXONE?
Teva 是否仍認為有非常關鍵和可信的理由不應批准仿製藥用於 COPAXONE?
And if you could remind investors what those might be.
如果你能提醒投資者那些可能是什麼。
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
Well thanks for the question.
好吧,謝謝你的提問。
I will forward this one to the scientists in the room.
我會把這個轉發給房間裡的科學家。
Michael, can you please refer to David's question?
邁克爾,你能參考大衛的問題嗎?
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
Thank you, David.
謝謝你,大衛。
I think Teva's position has been, and as you well know, there's been new data that we have published just in January that demonstrated significant differences in the biological immunological effects of COPAXONE and various purported generics.
我認為 Teva 的立場一直是,正如你所知,我們在 1 月份發布的新數據表明,COPAXONE 和各種聲稱的仿製藥的生物免疫效應存在顯著差異。
And whilst we recognize even now those investments that COPAXONE, by certain measures, can look similar to the purported generics.
雖然我們現在就認識到 COPAXONE 的那些投資,從某些方面來看,看起來與所謂的仿製藥相似。
In others that potentially have more clinical significance, which is partly activation and mechanism action, we're seeing significant differences.
在其他可能具有更多臨床意義的情況下,部分是激活和機製作用,我們看到了顯著差異。
Now we would never predict what the regulatory authorities and how they would interpret this.
現在我們永遠無法預測監管機構會做什麼以及他們會如何解釋這一點。
But I think from our own point of view, we see significantly different impact on genes associated, by the way, with key immune response mechanisms, that would further underlie the need for, really, to understand the clinical and biological effects of purported generics relative to COPAXONE.
但我認為,從我們自己的角度來看,我們看到對與關鍵免疫反應機制相關的基因產生顯著不同的影響,這將進一步成為了解所謂仿製藥相關臨床和生物學效應的必要性的基礎到 COPAXONE。
So we believe there's an important case in terms of patient safety and clinical efficacy to be made about the importance of clinical trials in this respect.
因此,我們認為就患者安全和臨床療效而言,有一個重要的案例可以說明臨床試驗在這方面的重要性。
David Maris - Analyst
David Maris - Analyst
Thank you very much.
非常感謝。
Operator
Operator
Randall Stanicky, RBC Capital Markets.
RBC 資本市場的 Randall Stanicky。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Great, thanks, guys, for the questions.
太好了,謝謝大家的提問。
Eyal, in light of the business development goals, which it sounds like you are open to any idea, how is that different from the last five years?
Eyal,鑑於業務發展目標,聽起來您對任何想法都持開放態度,這與過去五年有何不同?
Can you articulate how you're thinking about return on invested capital differently or strategically?
您能否闡明您是如何以不同的方式或戰略性地考慮投資資本回報率的?
Where you are looking to grow the Teva platform?
您希望在哪裡發展 Teva 平台?
And then I didn't hear you talk about divestitures.
然後我沒有聽到你談論資產剝離。
There's clearly a lot of businesses that you're in that perhaps isn't up to the profitability level that you'd like it to be in, perhaps couldn't be going forward.
很明顯,你所從事的很多業務可能達不到你希望的盈利水平,也許無法繼續前進。
Is that something you're looking at?
那是你正在看的東西嗎?
Could we see broader divestitures over the next 12 months or so?
我們能否在未來 12 個月左右看到更廣泛的資產剝離?
Thanks.
謝謝。
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
Let me try to take the two parts of the question.
讓我試著把問題的兩個部分。
First of all, on business opportunities, we are open for business.
首先,在商機上,我們是開放的。
Maybe in the past couple of years we've limited ourselves to small transactions, mostly focusing of building the pipeline and our portfolio.
也許在過去的幾年裡,我們將自己局限於小額交易,主要專注於建立管道和我們的投資組合。
I think we are expanding our thoughts, horizons and views on looking at some other ideas which are out there.
我認為我們正在擴大我們的思想、視野和觀點,看看外面的一些其他想法。
We are a very dynamic marketplace.
我們是一個充滿活力的市場。
So as I mentioned in my prepared remarks, we will be looking at any ideas that will create genuine value over time to the Company and to its shareholders.
因此,正如我在準備好的發言中提到的那樣,我們將研究任何能夠隨著時間的推移為公司及其股東創造真正價值的想法。
And I think everything else that I could say about this would be unnecessary at this point.
而且我認為此時我可以說的所有其他內容都是不必要的。
Regarding divestitures, yes, we are looking to divest some of the non-core parts of our business.
關於剝離,是的,我們正在尋求剝離我們業務的一些非核心部分。
It's not the core specialty, it's not the core generic.
它不是核心專科,也不是核心專科。
But the Company has some additional activities, such as the distributions and activities that don't really create or contribute a lot to our value.
但公司還有一些額外的活動,例如並沒有真正創造或貢獻我們價值的分銷和活動。
A number of investments over in financial and Companies that have accumulated over the years, all this is money that we're going to generate and put to it work to our core programs.
多年來積累的對金融和公司的大量投資,所有這些都是我們要產生的資金,並將其用於我們的核心項目。
So again, these things will have to be seen.
因此,必須再次看到這些東西。
Probably over 2014 we'll move into several of those actions.
可能在 2014 年,我們將採取其中幾項行動。
But we're not talking about divesting very large and central pieces of the Company, if that's what you meant to have said.
但我們不是在談論剝離公司非常大的核心部分,如果那是你的意思的話。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Thanks, Eyal.
謝謝,埃亞爾。
Is it fair to say that the Company has no bias then towards brand versus generic?
可以說公司對品牌和仿製藥沒有偏見嗎?
We could still see sizable generic additions to the business going forward?
我們仍然可以看到未來業務的大量通用添加嗎?
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
I would prefer to leave this question unanswered at this point, if you don't mind.
如果您不介意的話,我寧願在這一點上不回答這個問題。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Okay.
好的。
Great, thanks, guys.
太好了,謝謝,伙計們。
Operator
Operator
Corey Davis, National Alliance.
科里戴維斯,國家聯盟。
Corey Davis - Analyst
Corey Davis - Analyst
Thanks very much.
非常感謝。
Everything that's gone on at Teva over the past couple of years, and perhaps a change in focus in your generics business.
Teva 在過去幾年中發生的一切,也許還有仿製藥業務重心的改變。
Could you explain whether or not there's now a difference in your approach, if any, to how you think about and handle at-risk launches?
您能否解釋一下您現在的方法是否與您思考和處理風險發布的方式有所不同(如果有的話)?
I'm particularly interested in generic OxyContin, given your recent big court win on all those patents.
鑑於您最近在所有這些專利上贏得了重大法庭勝利,我對仿製藥 OxyContin 特別感興趣。
You're one of the few filers that hasn't yet settled and we're still waiting for FDA guidance on tamper equivalents.
您是為數不多的尚未解決的申報者之一,我們仍在等待 FDA 對篡改等同物的指導。
Is this something that conceivably could contribute to 2014 revenue, if all the stars align?
如果一切順利,這是否可以為 2014 年的收入做出貢獻?
Or is that probably too much of a stretch?
或者這可能太過分了?
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
Allan, will you take that please?
艾倫,你能接受嗎?
Allan Oberman - President and CEO of Teva America Generics
Allan Oberman - President and CEO of Teva America Generics
Sure, Corey.
當然,科里。
Let me start with the specific OxyContin question.
讓我從具體的 OxyContin 問題開始。
Clearly we were very pleased with the outcome of the litigation.
顯然,我們對訴訟結果非常滿意。
There are still a number of legal and regulatory hurdles to get over to be able to commercialize that and bring that to market.
要將其商業化並將其推向市場,仍有許多法律和監管障礙需要克服。
We are aggressively pursuing those.
我們正在積極追求這些。
And we would hope we can convert those into a first-mover advantage and economic benefit.
我們希望我們可以將這些轉化為先發優勢和經濟利益。
But I would say that there are hurdles ahead of us, including the fact that no generic has yet received regulatory approval on this product.
但我要說的是,我們面前還有障礙,包括目前還沒有仿製藥獲得該產品的監管批准。
But we are working with the FDA to do that.
但我們正在與 FDA 合作來做到這一點。
With reference to your question of at-risk launches, and someone who's been here for 14 years in the generics business, I can tell you that as we look at our paragraph 4, first-to-file strategy, we are aggressively looking at all opportunities where we can be first, create value, create sustainable value.
關於你的風險上市問題,以及一個在仿製藥行業工作了 14 年的人,我可以告訴你,當我們審視我們的第 4 段,先申請策略時,我們正在積極地研究所有我們可以率先創造價值、創造可持續價值的機會。
I would remind us however, relative to where the patent cliff has been, those opportunities in size and scale are not as great as they have historically been.
然而,我要提醒我們,相對於專利懸崖的位置,這些機會的規模和規模並不像歷史上那麼大。
But that said, they do create good economic value for us and we continue to focus upon them as part of our strategy.
但話雖如此,它們確實為我們創造了良好的經濟價值,我們將繼續將它們作為我們戰略的一部分。
I would just remind you that in December 2012, when we talked about the generics strategy, we said that more than 50% of all of our submissions have a first-to-file challenge associated with them, a paragraph 4 first-to-file challenge associated with them.
我只想提醒您,在 2012 年 12 月,當我們談到仿製藥戰略時,我們說我們所有提交的申請中有超過 50% 的申請與先申請相關,第 4 段先申請與他們相關的挑戰。
And that is our strategy going forward and will continue to be our strategy.
這是我們前進的戰略,並將繼續成為我們的戰略。
Corey Davis - Analyst
Corey Davis - Analyst
Quickly back to the FDA, you said that you are working with them.
快速回到 FDA,你說你正在與他們合作。
How would you characterize the nature of those interactions?
您如何描述這些相互作用的性質?
Do you think that they're close to coming up with tamper equivalents guidance?
您是否認為他們即將提出篡改等效指南?
Or is it premature to say that they are close?
或者現在說他們很親密還為時過早?
Allan Oberman - President and CEO of Teva America Generics
Allan Oberman - President and CEO of Teva America Generics
I think it's premature to give timelines on what the FDA will or will not do.
我認為現在就 FDA 會做什麼或不會做什麼給出時間表還為時過早。
But I will reiterate we are in close dialogue with them.
但我要重申,我們正在與他們進行密切對話。
Corey Davis - Analyst
Corey Davis - Analyst
Okay.
好的。
Thanks very much.
非常感謝。
Operator
Operator
Jami Rubin, Goldman Sachs.
賈米魯賓,高盛。
Jami Rubin - Analyst
Jami Rubin - Analyst
Thank you.
謝謝你。
Eyal, a question for you.
Eyal,問你一個問題。
I'm trying to understand the numbers this year.
我試圖了解今年的數字。
COPAXONE beat by $500 million, relative to your initial guidance, which by my math and the 76% operating margin that you disclosed for that product, should have produced a $0.40 beat over the midpoint of your guidance.
COPAXONE 比你最初的指導高出 5 億美元,根據我的數學計算和你為該產品披露的 76% 的營業利潤率,應該比你的指導中點高出 0.40 美元。
So clearly there were significant offsets.
很明顯,存在顯著的抵消。
And my best guess is that those offsets came from weaker generic sales and weaker operating margins or weaker profitability in the generic business.
我最好的猜測是,這些抵消來自仿製藥銷售疲軟和營業利潤率下降或仿製藥業務盈利能力下降。
Is that a correct characterization?
這是一個正確的表徵嗎?
What else in the base business created that shortfall to the very strong COPAXONE beat?
基礎業務中還有什麼造成了非常強大的 COPAXONE 擊敗的不足?
And how a we think about the profitability of the generic business going forward?
我們如何看待仿製藥業務未來的盈利能力?
I think that you gave guidance for 2014 of 41% to 44% generic gross margins.
我認為您為 2014 年提供了 41% 至 44% 的通用毛利率指導。
How should we think about that going forward?
我們應該如何考慮未來的發展?
And if you could explain, again, relative to your initial guidance, why the numbers came in so much below your expectations.
如果你能再次解釋一下,相對於你最初的指導,為什麼這些數字遠低於你的預期。
Thanks.
謝謝。
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
All right, thank you and good morning.
好的,謝謝,早上好。
There were some events in the business that offset the fantastic performance that we had with COPAXONE.
業務中有一些事件抵消了我們使用 COPAXONE 獲得的出色性能。
It wasn't just COPAXONE, it was also other parts of our specialty business.
不僅僅是 COPAXONE,它還涉及我們專業業務的其他部分。
And as we have reported, first and foremost, about $130 million of operating profit were robbed, so to speak, by exchange rates with some of the currency weakening against the dollar.
正如我們所報告的,首先也是最重要的是,大約 1.3 億美元的營業利潤被剝奪了,可以這麼說,因為一些貨幣對美元走弱的匯率。
And some strengthening against the dollar like the Israeli shekel, which hit into our operating profitabilities.
還有一些貨幣兌美元走強,例如以色列謝克爾,這影響了我們的經營利潤。
That's one piece.
那是一件。
We had a particularly week year in our third-party API business.
在我們的第三方 API 業務中,我們度過了特別平淡的一年。
A part of that has to do with managerial issues.
其中一部分與管理問題有關。
Part has to do with safety issues.
部分與安全問題有關。
And we have checked our entire networks, I believe that in 2014 were going to see much improvement in that area.
我們已經檢查了我們的整個網絡,我相信 2014 年我們會在該領域看到很大的改進。
A weakness in our generic business in Japan, again, part of that was strongly influenced by the weak Japanese yen.
我們在日本仿製藥業務的弱點,部分是受到日元疲軟的強烈影響。
To remind everyone, it was around JPY81 per dollar at the end of last year and it's JPY105, or over JPY100 right now.
提醒大家,去年年底是每美元 81 日元左右,現在是 105 日元,或超過 100 日元。
That something like 25% taking off profits right there.
大約 25% 的利潤就在那裡減少。
So there were parts of the business that went the other direction.
所以有些業務走向了另一個方向。
In operations we had to an excellent year.
在運營方面,我們度過了出色的一年。
We improved our service level dramatically.
我們大大提高了服務水平。
But at the same time, we cleaned out the house.
但與此同時,我們清理了房子。
That also resulted and then we have reported that throughout the year, writing off excess inventory in all our markets in order to come cleaner in 2014.
這也導致了,然後我們報告全年,註銷我們所有市場的過剩庫存,以便在 2014 年變得更清潔。
This number peaked, even peaked in the fourth quarter at about close to $190 million.
這個數字達到頂峰,甚至在第四季度達到頂峰,接近 1.9 億美元。
These numbers are not going to repeat next year.
這些數字明年不會重複。
So the combination of all that offsets our performance of the specialty business.
因此,所有這些因素的結合抵消了我們專業業務的表現。
As to your question on the profitability our generic.
至於你關於我們仿製藥盈利能力的問題。
You see the profitability of the generic business in Q4.
您會在第四季度看到仿製藥業務的盈利能力。
It's in line with what we have guided to 2014 and we believe that we're going to deliver that, at least.
這符合我們對 2014 年的指導,我們相信我們至少會實現這一目標。
A lot of our cost reduction programs are going to hit the bottom line of the generic business, as we said.
正如我們所說,我們的許多成本削減計劃將觸及仿製藥業務的底線。
It's not a one-sided picture.
這不是一張片面的照片。
We are going to improve and get a lot of money into the bottom line over our generic business in order to improve competitiveness.
我們將改善仿製藥業務的利潤並投入大量資金,以提高競爭力。
And we deploy some of the savings into the specialty business by building our future.
我們通過建設我們的未來將一些節省下來的資金投入到專業業務中。
But we believe the generic business of Teva is stable, is well managed, is going to grow in emerging markets.
但我們相信 Teva 的仿製藥業務穩定,管理良好,將在新興市場增長。
We had a pretty good, even excellent, second half in the United States business.
我們在美國業務的下半年表現非常好,甚至非常出色。
We improved the profitability in the European by exiting some of the low-profit activities like tenders in many of the countries which are common today.
我們通過退出一些低利潤活動,如當今在許多國家常見的招標,提高了歐洲的盈利能力。
And I believe we will see profitability improve in that area next year.
我相信明年我們會看到該領域的盈利能力有所提高。
Jami Rubin - Analyst
Jami Rubin - Analyst
Thank you.
謝謝你。
Operator
Operator
Elliot Wilbur, Needham and Company.
Elliot Wilbur, Needham and Company。
Elliot Wilbur - Analyst
Elliot Wilbur - Analyst
Thank you and good morning.
謝謝你,早上好。
If I could follow-up on Jami's question, specifically for Allan first initially.
如果我可以跟進 Jami 的問題,首先是針對 Allan。
In looking at the segment profitability measures on the overall generic business, my impression had always been the European business was generating segment profitability or op income profitability somewhere in the low to mid teens and obviously the US would be much higher.
在查看整體仿製藥業務的細分盈利能力指標時,我的印像一直是歐洲業務產生的細分市場盈利能力或營業收入盈利能力處於中低水平,顯然美國要高得多。
That doesn't seem to be the case.
事實似乎並非如此。
Maybe you could speak about the relative profitability of US generics versus Europe and the rest of the world.
也許你可以談談美國仿製藥相對於歐洲和世界其他地區的相對盈利能力。
And then I wanted to follow-up with more of a big-picture question.
然後我想跟進一個更宏觀的問題。
I'd direct this towards you as well, Allan.
艾倫,我也會把這件事交給你。
One of your larger international competitors is talking a lot about intensified consolidation, a distribution channel in the US, and now even more consolidation in a distribution system worldwide.
您的一個較大的國際競爭對手正在談論加強整合、美國的分銷渠道,以及現在全球分銷系統中的更多整合。
The suggestion there is that's just going to put a lot of pressure at the margin on some smaller players, and also potentially result in another leg down in overall pricing.
那裡的建議是,這只會給一些較小的參與者帶來很大的利潤壓力,並且還可能導致整體定價的另一波下跌。
Obviously the look at the data and especially in the US, certainly the numbers don't confirm that, because the price environment itself is relatively healthy.
顯然,看看數據,尤其是美國的數據,當然這些數字並不能證實這一點,因為價格環境本身相對健康。
What are your thoughts on that subject matter?
你對這個主題有什麼看法?
How do you see that playing out over the next 12 to 18 months here?
您如何看待未來 12 到 18 個月的發展?
Do you think the risk is really more relevant for smaller companies that don't have large portfolios?
您是否認為風險與沒有大型投資組合的小公司真的更相關?
Or do you think there's a growing risk of a far less favorable pricing environment going forward than investors seem to be expecting?
或者您是否認為未來定價環境遠不如投資者預期的風險越來越大?
Thanks.
謝謝。
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
Thanks, Elliot, it's Eyal.
謝謝,Elliot,我是 Eyal。
I'll take the first question of the overall comparison of our generic businesses around the world.
我將回答第一個問題,即我們在全球範圍內的仿製藥業務的整體比較。
Allan can definitely talk for the consolidation in the industry and what is happening in his field.
艾倫絕對可以談論行業整合以及他所在領域正在發生的事情。
On the scale that we're seeing, our US generic business is definitely the most profitable part, with gross margin at about the 50%.
就我們所看到的規模而言,我們的美國仿製藥業務絕對是最賺錢的部分,毛利率約為 50%。
It's a little over 40% in Europe.
在歐洲略高於 40%。
It's around 35%, but improving next year, in Japan.
日本的這一比例約為 35%,但明年會有所改善。
It's close to 50% in emerging markets.
在新興市場接近 50%。
And it's around 33% in our API business, which when you look at our overall generic business compared to last year, that is where we were hurt the most.
在我們的 API 業務中,這一比例約為 33%,與去年相比,當您查看我們的整體通用業務時,這是我們受到的傷害最大的地方。
But we believe we know how to fix it.
但我們相信我們知道如何解決它。
We also, in comparison of our total last year, did not have the Ranbaxy royalties on the atorvastatin launch, which was sales and EBIT were exactly the same number.
與去年的總數相比,我們也沒有在阿托伐他汀上市時獲得 Ranbaxy 特許權使用費,這是銷售額和息稅前利潤完全相同的數字。
Because there was no card, no sales expenses and that is missing from the numbers in the comparison.
因為沒有卡片,所以沒有銷售費用,比較中的數字也沒有。
Overall, we believe that our European business is stable.
總體而言,我們認為我們的歐洲業務是穩定的。
The US generic business is highly profitable.
美國仿製藥業務利潤豐厚。
And in Japan and API 2015 will be years what we will improve profitability.
在日本和 API 2015 年,我們將提高盈利能力。
Allan, do you want to talk about the consolidation of the industry, please?
艾倫,你想談談行業整合嗎?
Allan Oberman - President and CEO of Teva America Generics
Allan Oberman - President and CEO of Teva America Generics
Sure, Eyal.
當然,埃亞爾。
Thank you, Elliott.
謝謝你,埃利奧特。
Building on what Eyal said, we are reporting a 14% top-line growth on the US generics business in the fourth quarter.
根據 Eyal 所說,我們報告第四季度美國仿製藥業務的收入增長了 14%。
In the back half of the year when we have an apples to apples comparison of six months versus six months, we reached double-digit growth.
在今年下半年,當我們將六個月與六個月進行同類比較時,我們實現了兩位數的增長。
At the gross profit levels that Eyal was talking about, it is a very valuable business to Teva.
按照 Eyal 所說的毛利潤水平,這對 Teva 來說是一項非常有價值的業務。
And we see it continuing to be on a go-forward basis.
我們看到它繼續向前發展。
With regards to consolidation of the distribution base, definitely.
關於分銷基礎的整合,當然。
You know as well as I do, the three major transactions or combinations that have been announced in the last 12 months.
您和我一樣了解過去 12 個月內宣布的三項主要交易或合併。
We remain extremely optimistic about that consolidation.
我們對這種整合仍然非常樂觀。
We are finding, as we said in previous calls, that as our distributors globalize to increase their complexity and get bigger, they are looking to the large global players to be able to work with, to help them to find synergies of that they are looking for.
我們發現,正如我們在之前的電話會議中所說,隨著我們的分銷商全球化以增加他們的複雜性並變得更大,他們正在尋求能夠與之合作的大型全球參與者,以幫助他們找到他們正在尋找的協同效應為了。
We operate in 60 countries of the world.
我們在全球 60 個國家開展業務。
We have one of the biggest global footprints and we are well-positioned to capitalize on that globalization.
我們擁有最大的全球足蹟之一,我們有能力利用全球化。
We are already about 18 months into the Walgreens Alliance Boots combination with AmerisourceBergen coming on stream.
我們已經將 Walgreens Alliance Boots 與 AmerisourceBergen 的組合投入生產大約 18 個月。
We are working very closely with them in creating mutual value that helps them to achieve the synergy targets that they are looking for.
我們正在與他們密切合作,創造共同價值,幫助他們實現他們正在尋找的協同目標。
But also creates value for us and enhances the value creation in our business.
同時也為我們創造價值,增強我們業務的價值創造。
Overall I would concur with the trend that you are hearing.
總的來說,我同意你聽到的趨勢。
I do believe that the large global generic players will benefit from this globalization.
我確實相信大型全球仿製藥公司將從這種全球化中受益。
I do agree we will see some margin squeeze.
我同意我們會看到一些利潤擠壓。
They will look for a lower, or enhanced, margins.
他們會尋求更低或更高的利潤率。
But managing mix and pricing together, we can find a way to offset that and to continue to grow our business.
但同時管理組合和定價,我們可以找到一種方法來抵消這種影響並繼續發展我們的業務。
As we've seen in the last 6 months and in the last 12 months, if you exclude the atorvastatin royalty situation.
正如我們在過去 6 個月和過去 12 個月中看到的那樣,如果你排除阿托伐他汀專利使用費的情況。
Operator
Operator
Gregg Gilbert, Bank of America Merrill Lynch.
Gregg Gilbert,美銀美林。
Gregg Gilbert - Analyst
Gregg Gilbert - Analyst
Thanks.
謝謝。
Going back to the important product, for Michael first and then Rob.
回到重要的產品,首先是 Michael,然後是 Rob。
Michael, I like to put you on the spot on these calls, so I know that the financial guidance assumes generic COPAXONE around mid-year, but I'd like your personal view and your prediction as to whether generics would be approved on time, if you care to.
邁克爾,我想在這些電話會議上讓你當場,所以我知道財務指導假設仿製藥 COPAXONE 大約在年中,但我想听聽你對仿製藥是否會按時獲得批准的個人看法和預測,如果你願意的話。
And then for Rob, on the 40, you talked about the 30% to 50% goal that was based on market research.
然後對於 Rob,在 40 日,你談到了基於市場研究的 30% 到 50% 的目標。
And you've made that prediction as a Company, I think, over a year ago initially.
我認為,作為一家公司,您最初是在一年多以前就做出了這樣的預測。
Do have any real-time, real-world data based on patient flow or patient calls to physicians or actual visits in the past days that you could offer to make us more confident in your of 30% to 50% confidence?
您是否有任何基於患者流量或患者呼叫醫生或過去幾天實際就診的實時、真實世界的數據,您可以提供這些數據來讓我們對您的 30% 到 50% 的信心更有信心?
And the second part of that is that if the 20 go generic in a few months, is it fair to assume you would bridge any pricing gap to the patient who is on the 40 mg product, so that there's no incentive for that patient to move back to the 20?
第二部分是,如果 20 種藥物在幾個月內成為仿製藥,假設您將彌合任何價格差距與使用 40 毫克產品的患者之間是否公平,這樣就沒有動力讓該患者移動回到20?
Thank you.
謝謝你。
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
With regard to personal predictions.
關於個人預測。
No, I'm not going to make a prediction.
不,我不會做出預測。
But I am going to say there is compelling data that raises significant doubt about the clinical and biological effectiveness and similarity and sameness of purported generics and so we believe the onus should be on really demonstration of efficacy and safety.
但我要說的是,有令人信服的數據對所謂的仿製藥的臨床和生物學有效性以及相似性和相同性提出了重大質疑,因此我們認為責任應該在於真正證明療效和安全性。
It's important to -- of course, Teva is a generic Company.
這很重要——當然,Teva 是一家通用公司。
We understand what it is to show bio-equivalence and sameness.
我們了解顯示生物等效性和相同性是什麼意思。
We believe the same standards should be held here.
我們認為這裡應該採用相同的標準。
Rob Koremans - President and CEO of Specialty Medicine
Rob Koremans - President and CEO of Specialty Medicine
We stick to our guidance based on the most recent market research we have.
我們堅持基於我們最近的市場研究的指導。
And all of the interactions and feedback initially is exactly as we expected, so we continue to just give the same guidance, being optimistic about achieving those 30% to 50%.
所有的互動和反饋最初都完全符合我們的預期,因此我們繼續提供相同的指導,對實現 30% 到 50% 持樂觀態度。
As you can expect, we are really very, very closely monitoring all of this to be able to react to whatever need is there.
如您所料,我們真的非常、非常密切地監視所有這些,以便能夠對任何需要做出反應。
And as to pricing strategy going forward, honestly I'm not going to comment on that.
至於未來的定價策略,老實說我不會對此發表評論。
It's too much of a commercial strategy that I really don't feel comfortable disclosing at this point in time.
這是一個太多的商業策略,我真的不願意在這個時候透露。
Gregg Gilbert - Analyst
Gregg Gilbert - Analyst
Thank you.
謝謝你。
Operator
Operator
Ronny Gal, Sanford Bernstein.
羅尼加爾,桑福德伯恩斯坦。
Ronny Gal - Analyst
Ronny Gal - Analyst
Good morning and thank you for taking my question.
早上好,謝謝你提出我的問題。
First, regarding the CapEx, you're running over $1 billion COPAXONE.
首先,關於資本支出,您運行的 COPAXONE 超過 10 億美元。
I remember presentation from all your friends from Activis suggesting $250 million for the year.
我記得你所有來自 Activis 的朋友的演講都建議今年投入 2.5 億美元。
You did more than that in the quarter.
你在這個季度做的比這還多。
Can you give us a feel for the CapEx train going forward?
您能否讓我們了解一下未來的資本支出列車?
Should we begin to see a decline in that number?
我們應該開始看到這個數字下降嗎?
What is the goal for three years out?
三年的目標是什麼?
Second, TREANDA, we begin to see softness in the prescription.
其次,TREANDA,我們開始看到處方中的柔軟性。
Can you describe a little bit of the competitive dynamics with TREANDA?
您能描述一下與 TREANDA 的競爭動態嗎?
And third, obviously you've got a lot of stuff going in respiratory.
第三,顯然你有很多呼吸系統的東西。
Can you review for us where you are in terms of major pipeline products and launches?
您能否為我們回顧一下您在主要管道產品和發布方面的進展情況?
I think you mentioned a SYMBICORT look-alike.
我想你提到了一個 SYMBICORT 看起來很像。
And if you can also described where you are your ADVAIR program.
如果您還可以描述您所在的 ADVAIR 程序。
Thank you.
謝謝你。
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
I'll take the CapEx, Ronny, and then Rob will get your two others.
我會承擔資本支出,Ronny,然後 Rob 會得到你的另外兩個。
Our CapEx projecting for the year is close to $1 billion.
我們今年的資本支出預測接近 10 億美元。
The comparison that they are making, we need more details in order to understand it.
他們所做的比較,我們需要更多細節才能理解。
I'll tell you where we are investing.
我會告訴你我們在哪裡投資。
First of all we are doing an overhaul of our IT system, moving the entire Company to SAP.
首先,我們正在對我們的 IT 系統進行大修,將整個公司遷移到 SAP。
One system for the entire Company after a combination of many, many companies with different systems, that costs money.
在將許多具有不同系統的公司組合之後,整個公司的一個系統需要花錢。
We are building a new plant for the OTC products in India, a brand-new plant.
我們正在印度建設一個新的OTC產品工廠,一個全新的工廠。
And a new plant in Russia, which we announced about a year ago.
大約一年前我們宣佈在俄羅斯新建一家工廠。
These investments are ongoing.
這些投資正在進行中。
We are also investing in new technology, biologic capabilities.
我們還在投資新技術和生物能力。
Were investing in API.
正在投資 API。
Anybody that has an API business knows that that's a large consumer of capital investment.
任何擁有 API 業務的人都知道這是資本投資的大消費者。
So CapEx budget is about $1 billion.
所以資本支出預算約為 10 億美元。
We are looking at it in order to do the most efficient possible thing.
我們正在研究它,以便做最有效的事情。
We are also moving our production from a high-cost location to a low-cost location and expanding in Eastern Europe and in India, all consuming CapEx.
我們還將我們的生產從高成本地點轉移到低成本地點,並在東歐和印度擴張,所有這些都消耗了資本支出。
These are the numbers and these are the major items for our investment.
這些是數字,這些是我們投資的主要項目。
Rob, you want to go to TREANDA?
Rob,你想去 TREANDA?
Rob Koremans - President and CEO of Specialty Medicine
Rob Koremans - President and CEO of Specialty Medicine
TREANDA, it's how you define weak, but we are growing 17% year over year, out-performing the market in every single respect.
TREANDA,這是你定義弱的方式,但我們同比增長 17%,在各個方面都優於市場。
So I wouldn't call that weak.
所以我不會稱之為弱者。
And if interested in news on TREANDA, there's actually -- we've had a confirmation of a orphan drug status, which will give the indication, one of the indications, a protected life until February 2016.
如果對 TREANDA 的新聞感興趣,實際上有——我們已經確認了一種孤兒藥物的狀態,這將給出指示,指示之一,到 2016 年 2 月之前的受保護生命。
So TREANDA is doing really well, performance is good and we enjoy a longer protection than we believed a year ago.
所以 TREANDA 做得很好,性能很好,我們享受比一年前想像的更長的保護。
So actually we believe that's good news.
所以實際上我們認為這是個好消息。
On the respiratory pipeline, Michael, you want to comment on that?
關於呼吸管道,邁克爾,你想對此發表評論嗎?
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
Thank you, Rob, and thank you, Ronny.
謝謝你,羅布,謝謝你,羅尼。
With regard to the respiratory pipeline, of course this is the year we would expect results on our reslizumab study in mid-year.
關於呼吸管線,當然,今年是我們預計年中reslizumab 研究結果的年份。
So this is going to be an important year for that particular franchise.
因此,對於該特定特許經營權而言,今年將是重要的一年。
With regard to our whole R&D strategy, in terms of respiratory, it's broad-based.
關於我們的整個研發戰略,在呼吸方面,它是廣泛的。
As you probably recall, we have 10 clinical stage programs.
您可能還記得,我們有 10 個臨床階段項目。
We're targeting all the major drug classes.
我們的目標是所有主要的毒品類別。
And we're entering new valley high drug classes in asthma.
我們正在進入治療哮喘的新谷高藥物類別。
And also looking at adjacent disease areas like RSE coming out of our MicroDose acquisition.
並且還關注我們 MicroDose 收購後出現的 RSE 等鄰近疾病領域。
We're also, with the MicroDose acquisition, looking at next-generation devices that are really going to be focused also on the elderly and the young.
通過收購 MicroDose,我們也在尋找真正將重點放在老年人和年輕人身上的下一代設備。
We do have an 80-rated strategy the US, and this is underway.
我們在美國確實有一個 80 級的戰略,並且正在進行中。
Also, by the way, reflects tremendous integration.
另外,順便說一句,反映了巨大的整合。
A good example of integration between our branded and our generic business that come together very quickly as a result of the integrated organization.
作為整合組織的結果,我們的品牌業務和通用業務之間整合的一個很好的例子。
We are expecting about 13 submissions in the next five years and we're expecting strong growth from our current franchise, which is around $1 billion.
我們預計在未來五年內會收到大約 13 份申請,我們預計我們目前的特許經營權將實現強勁增長,約為 10 億美元。
This is a very strong, a burgeoning portfolio with tremendous upside.
這是一個非常強大的、新興的投資組合,具有巨大的上升空間。
Operator
Operator
David Amsellem, Piper Jaffray.
大衛·阿姆塞勒姆、派珀·杰弗瑞。
David Amsellem - Analyst
David Amsellem - Analyst
Thanks.
謝謝。
A couple, and I apologize if you are already addressed this.
一對夫婦,如果您已經解決了這個問題,我深表歉意。
Can you talk about the rate at which you're losing COPAXONE patients to the orals in the fourth quarter and into 1Q?
你能談談你在第四季度和第一季度失去口服 COPAXONE 患者的速度嗎?
Do you see that potentially accelerating over time, as neurologists gain more comfort with the orals that are available?
隨著神經學家對可用的口服藥物越來越熟悉,您是否看到這種情況可能會隨著時間的推移而加速?
Thanks.
謝謝。
Rob Koremans - President and CEO of Specialty Medicine
Rob Koremans - President and CEO of Specialty Medicine
David, so far actually what we've seen is a fairly minimal impact of competition.
大衛,到目前為止,實際上我們所看到的是競爭的影響相當小。
COPAXONE is and remains the golden standard.
COPAXONE 是並且仍然是黃金標準。
I think this is related to the effect that people, patients and doctors alike, trust its proven efficacy and safety, its entire clinical profile, and all of the experience.
我認為這與人們、患者和醫生都相信其經過驗證的有效性和安全性、其整個臨床概況以及所有經驗的影響有關。
So actually for five months in a row COPAXONE is now the leader in new prescriptions.
所以實際上,COPAXONE 已經連續五個月成為新處方的領導者。
It was always the leader in total prescriptions.
它始終是總處方的領導者。
So there has been obviously some sort of a market share taken by the orals.
因此,口述顯然佔據了某種市場份額。
All In all, it's a very low-digit, single-digit loss that we've had and COPAXONE is holding much, much better than I think many people expected 12 months ago.
總而言之,這是一個非常低的個位數損失,我們的損失比我認為許多人 12 個月前的預期要好得多。
Frankly that's going forward into 2014 is what we are expecting is COPAXONE will hold its ground.
坦率地說,我們預計 COPAXONE 將在 2014 年站穩腳跟。
Obviously the orals will continue to gain some market share, but at the moment we see it grow more at cost of some of the interferons than really at the cost of COPAXONE.
顯然,口服藥物將繼續獲得一些市場份額,但目前我們看到它的增長更多是以乾擾素為代價的,而不是真正以 COPAXONE 為代價的。
Operator
Operator
Thank you.
謝謝你。
I will now turn the call back to Eyal Desheh for any closing comments.
我現在將把電話轉回給 Eyal Desheh,徵求任何結束意見。
Eyal Desheh - Acting President and CEO
Eyal Desheh - Acting President and CEO
Thank you very much, Dawn.
非常感謝你,黎明。
Thank you for your questions.
謝謝你的問題。
We will be taking calls from anybody that wants to contact us immediately after this conference call is over.
本次電話會議結束後,我們將接聽任何想立即聯繫我們的人的電話。
We will be happy to answer all of the additional questions that you may still have.
我們很樂意回答您可能還有的所有其他問題。
And we will talk to you during the quarter and on our next earnings call.
我們將在本季度和下一次財報電話會議上與您交談。
Thank you very much and have a wonderful day.
非常感謝,祝你有美好的一天。
Operator
Operator
Thank you, ladies and gentlemen, this concludes today's conference.
女士們先生們,謝謝你們,今天的會議到此結束。
Thank you for participating.
感謝您的參與。
You may now disconnect.
您現在可以斷開連接。