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Operator
Operator
Welcome to the Teva Pharmaceutical Industries, Ltd.
歡迎來到 Teva Pharmaceutical Industries, Ltd.
first quarter 2013 earnings conference call.
2013年第一季度財報電話會議。
My name is Sandra and I will be your operator for today's call.
我叫桑德拉,我將擔任今天電話會議的接線員。
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 Mr. Kevin Mannix, Vice President, 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 先生。
Mr. Mannix, you may begin.
Mannix 先生,您可以開始了。
- VP of Global IR
- VP of Global IR
Thank you, Sandra.
謝謝你,桑德拉。
Good morning and good afternoon, everyone.
大家早上好,下午好。
Thank you for joining us today to review Teva's first quarter 2013 earnings results.
感謝您今天加入我們,回顧 Teva 2013 年第一季度的收益結果。
I'm joined today by our President and CEO, Dr. Jeremy Levin; our CFO, Eyal Desheh; Rich Egosi, Executive Vice President and Chief Legal Officer; Dr. Michael Hayden, President Global R&D and Chief Scientific Officer; Allan Oberman, President and CEO of Teva America's Generics; Carlo De Notaristefani, President and CEO of Global Operations; Dr. Rob Koremans, President and CEO of Global Specialty Medicines, Teva Europe; and John Connelton, Senior Vice President, Global Medicines.
今天,我們的總裁兼首席執行官 Jeremy Levin 博士加入了我的行列;我們的首席財務官 Eyal Desheh; Rich Egosi,執行副總裁兼首席法務官;全球研發總裁兼首席科學官 Michael Hayden 博士;梯瓦美國仿製藥公司總裁兼首席執行官艾倫·奧伯曼 (Allan Oberman);全球運營總裁兼首席執行官 Carlo De Notaristefani; Teva Europe 全球特種藥物總裁兼首席執行官 Rob Koremans 博士;和全球藥品高級副總裁 John Connelton。
Jeremy will begin by providing an overview of the highlights from the quarter and year, followed by Eyal, who will then provide additional details on our consolidated financial results.
Jeremy 將首先概述本季度和年度的亮點,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, which will run until approximately 9.00 AM Eastern Time.
然後,我們將開始徵集問答環節,該環節將持續到東部時間上午 9 點左右。
Before we start I would like to remind you that our discussions during the conference call will include forward-looking statements.
在我們開始之前,我想提醒您,我們在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.
實際結果可能與前瞻性陳述中預測的結果存在重大差異。
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、供應鏈中斷以及其他可能導致實際結果出現差異的因素,如 Teva 在 20-F 表和 6-K 表的報告中所討論的那樣。
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,我們還提供非 GAAP 數據,其中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。
These are amounts we can not predict at this point.
這些是我們目前無法預測的數量。
As mentioned in the past, we present these non-GAAP figures to show you how we, the management team and our Board of Directors, look at our financial data.
正如過去所提到的,我們提供這些非 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數據。
With that I'll now turn the call over to Jeremy.
有了這個,我現在將電話轉給傑里米。
Jeremy, if you would please.
傑里米,如果你願意的話。
- President and CEO
- President and CEO
Thank you Kevin.
謝謝凱文。
Good morning everyone.
大家,早安。
And thank you for joining us on the call today to discuss Teva's first quarter 2013 results.
感謝您今天加入我們的電話會議,討論 Teva 2013 年第一季度的業績。
During my remarks this morning, I will briefly recap the first quarter and more recent highlights and will emphasize the key milestones related to the implementation of our overall plan and strategy for the Company.
在今天上午的發言中,我將簡要回顧第一季度和最近的亮點,並強調與實施公司總體計劃和戰略相關的重要里程碑。
I joined the Company as CEO nearly exactly a year ago, May 2012.
將近一年前,即 2012 年 5 月,我加入公司擔任首席執行官。
Since that time, we have developed and articulated our global strategy, most recently in December.
從那時起,我們制定並闡明了我們的全球戰略,最近一次是在 12 月。
The strategy is based upon six pillars, to accelerate growth platforms, extend our global presence, execute on strategic business development, protect and expand our core franchises, reduce our operating costs, and develop, retain and recruit world-class employees.
該戰略基於六大支柱,加速增長平台,擴大我們的全球影響力,執行戰略業務發展,保護和擴大我們的核心特許經營權,降低我們的運營成本,以及培養、留住和招聘世界一流的員工。
We are executing vigorously on our strategic plan and are well advanced in many of the efforts to reach our goals.
我們正在積極執行我們的戰略計劃,並在實現我們目標的許多努力中取得了長足的進步。
As a result, I firmly believe that Teva is poised to seize today's opportunities and successfully meet our industry's changing dynamics tomorrow.
因此,我堅信 Teva 已準備好抓住今天的機遇,並在明天成功迎接我們行業不斷變化的動態。
In regard to our product portfolio, our focus is on high-value and sustainable products.
關於我們的產品組合,我們的重點是高價值和可持續的產品。
We'll continue to expand our business in high-value generics, including brand generics, industrialized new therapeutic entities, or NTEs, which have high barriers to entry, focus on specialty brand, which includes Copaxone, Treanda and Azilect.
我們將繼續擴大我們在高價值仿製藥方面的業務,包括品牌仿製藥、工業化新治療實體或 NTE,它們具有很高的進入壁壘,專注於專業品牌,包括 Copaxone 、 Treanda 和 Azilect 。
We will develop new branded products for areas of high medical need in CNS and respiratory diseases and expand our efforts in OTC through our joint venture with Procter & Gamble.
我們將為中樞神經系統和呼吸系統疾病等高醫療需求領域開發新的品牌產品,並通過與寶潔公司的合資企業擴大我們在 OTC 領域的努力。
Most recently, as part of the strategic plan, we announced the formation of our Global Specialty Medicines group, known as GSM, with Rob Koremans as President and CEO of this group.
最近,作為戰略計劃的一部分,我們宣布成立我們的全球專業藥物集團,即 GSM,Rob Koremans 擔任該集團的總裁兼首席執行官。
Our goal is to create a structure that works seamlessly with our regional generics team to establish a single differentiated Teva presence in the market.
我們的目標是創建一個與我們的區域仿製藥團隊無縫協作的結構,以在市場上建立單一差異化的 Teva 存在。
We will build up Teva's strong local presence, establish an high quality and accessible generics to leverage our global scale and capabilities in specialty medicine.
我們將建立 Teva 強大的本地影響力,建立高質量且可獲得的仿製藥,以利用我們在專業醫學方面的全球規模和能力。
We now have an organizational structure in place, which supports our strategic plan.
我們現在有了一個支持我們戰略計劃的組織結構。
Business development, as you know, is a key driver for Teva's success in the future, and its continued leadership in generics, OTC and branded markets.
如您所知,業務發展是 Teva 未來成功及其在仿製藥、非處方藥和品牌藥市場持續領先地位的關鍵驅動力。
While we continue to optimize and expand our core businesses we will build our pipeline and portfolio through a combination of R&D activities and business development transactions, including strategic alliances, licensing, and small acquisitions.
在我們繼續優化和擴展我們的核心業務的同時,我們將通過結合研發活動和業務發展交易(包括戰略聯盟、許可和小型收購)來構建我們的管道和產品組合。
I'm particularly pleased to announce earlier this week that Paul Sekhri will join Teva's group as Executive Vice President Global Business Development and Chief Strategy Officer.
本週早些時候,我特別高興地宣布,Paul Sekhri 將加入 Teva 的團隊,擔任全球業務發展執行副總裁兼首席戰略官。
Paul will work closely with me to execute an optimal business development strategy.
Paul 將與我密切合作,以執行最佳的業務發展戰略。
I think many of you know Paul and are familiar with his extensive experience in the life sciences industry, including his diverse background with generic and pharmaceutical strategies, with a range of organizations including multi-national entities, small firms and venture groups.
我想你們中的許多人都認識 Paul 並且熟悉他在生命科學行業的豐富經驗,包括他在仿製藥和製藥戰略方面的多元化背景,以及一系列組織,包括跨國實體、小公司和風險集團。
Due to the efforts of the Company over the last year, we now have a solid and unique business infrastructure in place.
由於公司過去一年的努力,我們現在擁有穩固而獨特的業務基礎設施。
This allows Teva to more effectively leverage its strengths in both generics and specialty brands through business development.
這使 Teva 能夠通過業務發展更有效地利用其在仿製藥和專業品牌方面的優勢。
Overall, the actions I have taken during my first year at Teva underscore my complete commitment to several key areas, a streamlined business through operational discipline, the expansion of a global leadership team with deep expertise and experience, a creative and strategic approach to R&D, an aggressive pursuit of business development opportunities that compliment and enhance our core businesses in key therapeutic areas, and the management of the organization for profitability and profitable growth.
總的來說,我在 Teva 的第一年採取的行動強調了我對幾個關鍵領域的完全承諾,通過運營紀律精簡業務,擴大具有深厚專業知識和經驗的全球領導團隊,創造性和戰略性的研發方法,積極尋求業務發展機會,以補充和加強我們在關鍵治療領域的核心業務,以及組織的管理以實現盈利和盈利增長。
Now, looking at the quarter, some of the highlights include the following.
現在,看看本季度,一些亮點包括以下內容。
Our Generics business performed as planned and in line with our expectations and was in particularly strong in Western Europe and Eastern Europe.
我們的仿製藥業務按計劃進行,符合我們的預期,在西歐和東歐尤其強勁。
Our strategy for our Generic business is to continue to focus on profitability and sustainable profitable growth.
我們的仿製藥業務戰略是繼續關注盈利能力和可持續的盈利增長。
Sales for Copaxone of $1.1 billion were realized in first quarter of 2013 and were 17% up over first quarter of 2012.
Copaxone 的銷售額在 2013 年第一季度實現了 11 億美元,比 2012 年第一季度增長了 17%。
During the first quarter, Copaxone continued to lead the US in global relapsing remitting multiple sclerosis market in both sales and market share.
第一季度,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繼續領先美國。
Over the past several years, the RRMS market has become crowded with various therapeutic options including several oral therapies.
在過去的幾年裡,RRMS 市場已經充斥著各種治療選擇,包括幾種口服療法。
As we look to the future, there are extremely important considerations that patients and physicians need to contemplate when choosing the best treatment option to manage this chronic disease over a patient's lifetime.
展望未來,在選擇最佳治療方案以在患者的一生中管理這種慢性疾病時,患者和醫生需要考慮一些極其重要的考慮因素。
We strongly believe that Copaxone's well established clinical experience and unsurpassed 20-year efficacy and safety profile in an extremely unpredictable disease will continue as a viable treatment option for physicians and patients when selecting a long-term therapy.
我們堅信,Copaxone 在一種極其不可預測的疾病中的成熟臨床經驗和無與倫比的 20 年療效和安全性概況將繼續作為醫生和患者在選擇長期治療時的可行治療選擇。
Additionally, we continue to seek ways to enhance patient's experience with Copaxone, and are pleased to announce that on March 29, Teva filed with the US FDA, the three times weekly dosing of Copaxone, 40 milligrams per mill, and we anticipate FDA action in the first quarter next year.
此外,我們繼續尋找方法來增強患者對 Copaxone 的體驗,並很高興地宣布,Teva 於 3 月 29 日向美國 FDA 提交了每週三次的 Copaxone 劑量,每次 40 毫克,我們預計 FDA 將採取行動明年第一季度。
We are excited about the possibility of providing an alternative therapeutic option for 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 提供替代治療方案。
Moving on to Teva's other CNS products.
轉向 Teva 的其他 CNS 產品。
In our Parkinson's franchise Azilect revenue increased 29% and continues to experience strong prescription growth globally.
在我們的帕金森特許經營中,Azilect 的收入增長了 29%,並繼續在全球範圍內實現強勁的處方增長。
Further, in our Wakefulness franchise, despite multiple generic Modafinil competitors Nuvigil continues to maintain over 50% of the new prescription shares.
此外,在我們的 Wakefulness 特許經營權中,儘管有多個通用莫達非尼競爭對手,Nuvigil 繼續保持超過 50% 的新處方份額。
Teva's overall Oncology business was up 13% in the first quarter of 2013, as compared to the same period of 2012.
與 2012 年同期相比,Teva 的整體腫瘤業務在 2013 年第一季度增長了 13%。
We continue to see strong results in our Oncology franchise from Treanda and revenues increased over 16% year over year.
我們繼續看到 Treanda 在我們的腫瘤專營權方面取得了強勁的成果,收入同比增長超過 16%。
Additionally, the life cycle program for Treanda continues to move forward as the Treanda LQ liquid formulation supplement was accepted by the US FDA for priority review.
此外,隨著 Treanda LQ 液體製劑補充劑被美國 FDA 接受優先審查,Treanda 的生命週期計劃繼續向前推進。
Further, in Oncology, launch plans of Teva's Tbo-Filgrastim, our short-acting G-CSF product have been finalized and a full commercial launch is on schedule in Japan in May and in the US in the fourth quarter of this year.
此外,在腫瘤領域,我們的短效 G-CSF 產品 Teva 的 Tbo-Filgrastim 的上市計劃已經完成,併計劃於 5 月在日本和今年第四季度在美國全面上市。
In our Respiratory franchise we saw strong growth.
在我們的呼吸專營權方面,我們看到了強勁的增長。
ProAir HFA with dose counter was successfully launched and realized a full brand conversion.
帶劑量計數器的ProAir HFA成功上市,實現全品牌轉換。
In the US, ProAir remains the class leader with over a 51% market share.
在美國,ProAir 仍然是同類產品的領導者,市場份額超過 51%。
We are particularly pleased with QVar's continued strong performance this quarter as well.
我們對 QVar 在本季度的持續強勁表現也感到特別滿意。
For the first time, US total new prescription share exceeded 30% of market share and brand growth out-paced the class growth four-fold.
美國新處方藥的總份額首次超過市場份額的 30%,品牌增長速度超過類別增長速度四倍。
As we look regionally in Europe, the quarter resulted in double-digit growth in both sales and profits compared to the first quarter of 2012.
從歐洲區域來看,與 2012 年第一季度相比,該季度的銷售額和利潤均實現兩位數增長。
Teva's EU efforts resulted in an 11% increase in revenue, a 38% increase in operating profit year over year.
Teva 在歐盟的努力使收入同比增長 11%,營業利潤同比增長 38%。
These results were primarily driven by generic launches above market growth in our OTC business and a positive impact on Copaxone sales.
這些結果主要是由非處方藥業務高於市場增長的仿製藥上市以及對 Copaxone 銷售的積極影響所推動的。
Our strategy continues to focus on winning sustainable and profitable business as we continue to focus on diversity, reach and flexibility in Europe.
隨著我們繼續關注歐洲的多樣性、影響力和靈活性,我們的戰略繼續專注於贏得可持續和盈利的業務。
For the second consecutive quarter Teva achieved record overall sales in the EMEA region.
Teva 連續第二個季度在 EMEA 地區實現了創紀錄的整體銷售額。
We are pleased to report sales increase of 32% in the first quarter of 2013 versus the first quarter of 2012.
我們很高興地報告 2013 年第一季度與 2012 年第一季度相比銷售額增長了 32%。
This increase was primarily due to the strong OTC revenue, which was led by Russia and Israel.
這一增長主要是由於強勁的場外交易收入,其中俄羅斯和以色列為首。
The OTC business is strategically important for us and we see the PGT JV partnership as a key to this business success.
OTC 業務對我們具有重要的戰略意義,我們將 PGT JV 夥伴關係視為業務成功的關鍵。
Our efforts have resulted in strong sales growth of 29% with exceptional growth in EMEA and Latin.
我們的努力帶來了 29% 的強勁銷售增長,歐洲、中東和非洲 (EMEA) 和拉丁地區的銷售額增長驚人。
We are very pleased with our program in R&D.
我們對我們的研發計劃感到非常滿意。
In particular, the NTE strategy, which Dr. Michael Hayden and his team have already identified 50 candidates for NTEs and four of them have already been approved or entered into development.
特別是 NTE 策略,Michael Hayden 博士和他的團隊已經確定了 50 個 NTE 候選者,其中四個已經獲得批准或進入開發階段。
Last week we also announced, with our collaborator, Xenon, the US FDA had granted orphan drug designation to XEN402.
上週,我們還與我們的合作者 Xenon 一起宣布,美國 FDA 已授予 XEN402 孤兒藥稱號。
We are excited by the promise of XEN402, which has shown an early proof of concept trials, and are committed to its development as a novel therapy for the treatment of pain associated with erythromelalgia.
我們對 XEN402 的前景感到興奮,它已經顯示出早期的概念試驗證明,並致力於將其開發為治療紅斑性肢痛相關疼痛的新型療法。
It is well recognized as a tremendous unmet medical need for safe and effective medicines to treat pain.
眾所周知,人們對安全有效的疼痛治療藥物存在巨大的未滿足醫療需求。
XEN402 offers promise.
XEN402 提供承諾。
I would now like to take a moment to discuss cost management and initial steps that have been taken over the past month.
我現在想花點時間討論成本管理和過去一個月採取的初步措施。
As part of the Company's overall efficiency and productivity strategy, we have initiated the divestment process for the manufacturing plant in Irvine, California as recently announced.
作為公司整體效率和生產力戰略的一部分,我們已經啟動了最近宣布的加利福尼亞爾灣製造廠的撤資流程。
And in addition the seller's PA site will cease operations.
此外,賣家的 PA 網站將停止運營。
This plant will remain active and productive until it closes in 2017.
在 2017 年關閉之前,該工廠將保持活躍和高產。
Additionally, I'm very pleased to share with you that Lisa Martin, formerly Head of Global Procurement at Pfizer joins Teva as Chief Procurement Officer and will put in place a comprehensive procurement strategy.
此外,我很高興與大家分享,輝瑞公司前全球採購主管 Lisa Martin 加入 Teva 擔任首席採購官,並將製定全面的採購戰略。
Our commitment cost saving remains a high priority, and as we have addressed previously, we anticipate most of these savings will be realized between 2014 and 2017.
我們承諾的成本節約仍然是重中之重,正如我們之前提到的,我們預計這些節約中的大部分將在 2014 年至 2017 年之間實現。
We remain on track with our goals of cost based improvement.
我們始終致力於實現基於成本的改進目標。
Before turning the call over to Eyal, who will review Teva's first quarter financial results in more detail, I would like to emphasize that Teva's leadership team is committed to managing the Company to generate long-term and sustainable growth in our business.
在將電話轉給 Eyal 之前,他將更詳細地審查 Teva 第一季度的財務業績,我想強調 Teva 的領導團隊致力於管理公司,以實現我們業務的長期和可持續增長。
Teva is uniquely positioned with a broad global footprint in both generic and branded medicine.
Teva 在仿製藥和品牌藥領域擁有廣泛的全球足跡,處於獨特的地位。
This, we strongly believe is a major competitive advantage.
我們堅信這是一個主要的競爭優勢。
It is my belief that over the past year we have created the strategy that will guide Teva into an exciting future as a leader in both generics and branded medicines.
我相信,在過去的一年裡,我們制定的戰略將引導 Teva 作為仿製藥和品牌藥領域的領導者走向激動人心的未來。
We are executing vigorously against that strategy.
我們正在大力執行該戰略。
We look forward to keeping you informed of our progress.
我們期待著讓您了解我們的進展。
Now thank you for your time and, Eyal, perhaps you'll take over.
現在感謝你的時間,Eyal,也許你會接手。
- CFO
- CFO
Thank you, Jeremy.
謝謝你,傑里米。
And good morning everyone.
大家早上好。
2013 is going to be a pivotal year for Teva.
2013 年將是 Teva 的關鍵一年。
We are diligently working on transforming our Company and reshaping many aspects of its business and operations in accordance with the pillars of the new strategy we have laid out late last year, and we have seen good progress made on many fronts.
我們正在根據我們去年底制定的新戰略的支柱,努力改造我們的公司並重塑其業務和運營的許多方面,我們已經看到在許多方面取得了良好進展。
We are streamlining a line of business and starting to increase operational efficiency, but continue to amend our business model towards a sustainable and profitable organic growth, and adjust our go-to-market draw-outs accordingly.
我們正在精簡業務線並開始提高運營效率,但會繼續修改我們的業務模型以實現可持續和盈利的有機增長,並相應地調整我們的上市時間。
At the same time, we continue to solidify and focus our R&D efforts, protect our core franchises while managing the life cycle of our key assets, and pursue select business development opportunities.
與此同時,我們繼續鞏固和集中我們的研發工作,保護我們的核心特許經營權,同時管理我們關鍵資產的生命週期,並尋求精選的業務發展機會。
Today we are pleased to share with you our financial results for the first quarter of 2013.
今天,我們很高興與您分享我們 2013 年第一季度的財務業績。
Generally speaking, we had a good quarter, with some top year over year comparisons to the first quarter of 2012, for reasons I'm going to discuss in a minute.
總的來說,我們有一個很好的季度,與 2012 年第一季度相比有一些同比增長,原因我稍後會討論。
Many of our businesses performed well this quarter, in particular our generic business in Europe that delivered strong growth, a global specialty medicines business that maintains similar year over year safe levels, despite the loss of exclusivity of an important product like Provigil.
本季度我們的許多業務表現良好,尤其是我們在歐洲的仿製藥業務實現了強勁增長,全球特種藥品業務保持了與去年同期相似的安全水平,儘管 Provigil 等重要產品失去了獨家經營權。
And finally our OTC business, that delivered a very strong growth rates compared to last year, building on strong fundamentals.
最後,我們的場外交易業務在強勁的基本面基礎上,與去年相比實現了非常強勁的增長率。
During this first quarter, we also generated significant cash flow from operation and reduced our financial leverage.
在第一季度,我們還從運營中產生了大量現金流,並降低了我們的財務槓桿。
Before I dive into the numbers I would like to touch on two matters.
在我深入研究這些數字之前,我想談兩件事。
The adjustment we performed to our GAAP results and the exchange rate differences affecting our results.
我們對 GAAP 結果進行的調整以及影響我們結果的匯率差異。
This quarter we made adjustments total $330 million after tax to our GAAP results.
本季度,我們對 GAAP 業績進行了總計 3.3 億美元的稅後調整。
The biggest adjustment was $279 million for amortization of purchase intangible assets, and final expenses of $94 million in connection with one-time expenses related to earlier redemption of senior notes and others.
最大的調整是 2.79 億美元用於購買無形資產的攤銷,以及與提前贖回優先票據和其他相關的一次性費用相關的最終費用 9400 萬美元。
Accordingly, our non-GAAP net income and non-GAAP earnings per share 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 淨收入和非 GAAP 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。
In the first quarter we experienced the weakening of the Japanese yen and certain Latin American currencies versus the US dollar.
在第一季度,我們經歷了日元和某些拉美貨幣兌美元的疲軟。
This fluctuation and several other minor ones had a negative impact of $35 million on revenues and $12 million on operating income this quarter, compared to the first quarter of 2012.
與 2012 年第一季度相比,這一波動和其他幾個小波動對本季度的收入產生了 3500 萬美元的負面影響,對營業收入產生了 1200 萬美元的負面影響。
Let me move on now to the actual first quarter results.
現在讓我繼續討論第一季度的實際結果。
By reporting net revenues of $4.9 billion, a decrease of 4% compared to the first quarter of 2012, non-GAAP operating income of $1.3 billion, an increase of 21%, non-GAAP net income of $960 million, an increase of 26% and non-GAAP diluted earnings per share of $1.12, a decrease of 24% compared to the comparable quarter last year.
通過報告淨收入為 49 億美元,與 2012 年第一季度相比下降 4%,非 GAAP 營業收入為 13 億美元,增長 21%,非 GAAP 淨收入為 9.6 億美元,增長 26%非 GAAP 攤薄後每股收益為 1.12 美元,與去年同期相比下降 24%。
The decreases and the overall challenging quarter over quarter comparison were largely driven by the anticipated effect of Provigil going off patent in the second quarter of 2012, coupled with the significant launches we benefited from in the first quarter of 2012, primarily of the generic version of Zyprexa and our agreement with Ranbaxy relating to its launch of generic Lipitor.
環比下降和整體挑戰性季度比較主要是由於 Provigil 在 2012 年第二季度專利到期的預期影響,以及我們在 2012 年第一季度受益的重大發布,主要是仿製藥版本Zyprexa 以及我們與 Ranbaxy 就其推出仿製立普妥達成的協議。
These were partially offset by higher sales of some of our other specialty products, strong generic sales in Europe and OTC sales.
這些部分被我們其他一些特殊產品的銷售額增加、歐洲仿製藥銷售強勁和 OTC 銷售所抵消。
If we eliminate the effect of Provigil, organic sales growth net of foreign exchange impact was 2.4% compared to the first quarter of 2012, despite the loss of exclusive generic products in the US market.
如果我們剔除 Provigil 的影響,與 2012 年第一季度相比,扣除外匯影響的有機銷售增長為 2.4%,儘管美國市場的獨家仿製藥產品有所減少。
I want to briefly touch on several highlights of our financial performance this quarter by product line and geography.
我想按產品線和地理位置簡要介紹本季度我們財務業績的幾個亮點。
Sales of generic medicine this quarter were approximately $2.3 billion including API sales to third party of $186 million, a decrease of 12% compared to the first quarter of 2012.
本季度仿製藥的銷售額約為 23 億美元,其中 API 向第三方的銷售額為 1.86 億美元,與 2012 年第一季度相比下降了 12%。
This decrease is mainly the result of the comparison with exclusive generic products we had in the US in the first quarter of 2012, which were only partially offset by new launches we had during 2012 and in the first quarter of 2013.
這一下降主要是與我們 2012 年第一季度在美國擁有的獨家仿製藥產品進行比較的結果,這僅被我們在 2012 年和 2013 年第一季度推出的新產品部分抵消了。
Launches of new generic products in the US market had a minimal impact this quarter.
本季度在美國市場推出新仿製藥的影響微乎其微。
We expect our US generic business to materially improve in the second half of the year with launches of new generic products in parallel with solid performance of our European generic business, increasing revenues by 11% year over year to $873 million.
我們預計我們的美國仿製藥業務將在下半年大幅改善,推出新的仿製藥產品,同時我們的歐洲仿製藥業務表現穩定,收入同比增長 11% 至 8.73 億美元。
In our Specialty business we had $2.1 billion of revenues this quarter, which were flat compared to the first quarter of 2012, despite the loss of exclusivity of Provigil in April last year.
在我們的專業業務中,本季度我們的收入為 21 億美元,與 2012 年第一季度相比持平,儘管去年 4 月失去了 Provigil 的獨家經營權。
We were successful in bridging this revenue gap by significantly growing several of our other specialty medicines, primarily Copaxone, Treanda, QVar and Azilect with good sales of specialty products in Europe.
我們通過顯著增長我們的其他幾種專科藥物(主要是 Copaxone、Treanda、QVar 和 Azilect)並在歐洲銷售良好的專科藥物,成功地彌補了這一收入缺口。
Finally, let me turn to the strong results of our OTC business.
最後,讓我談談我們場外交易業務的強勁業績。
Overall, OTC sales this quarter reached $306 million, an increase of 56% compared to the first quarter of 2012.
總體而言,本季度 OTC 銷售額達到 3.06 億美元,與 2012 年第一季度相比增長了 56%。
I want to turn next to profit margins and operating expenses.
接下來我想談談利潤率和運營費用。
Non-GAAP gross profit margin was 58.6% this quarter, compared to 60.9% in the first quarter of 2012, a decline that is also attributable to the loss of Provigil and certain exclusive US generic products which were very profitable.
本季度非美國通用會計準則毛利率為 58.6%,而 2012 年第一季度為 60.9%,下降的原因還在於 Provigil 和某些利潤豐厚的獨家美國仿製藥產品的虧損。
Many of the steps we are taking these days as part of our plan to reshape Teva and save on costs, including the creation of our new Global Procurement organization and the recent site closure we announced are geared towards improving our gross profit margin.
作為我們重塑 Teva 和節省成本計劃的一部分,我們最近採取的許多步驟,包括創建我們新的全球採購組織和我們最近宣布的工廠關閉,都是為了提高我們的毛利率。
As Jeremy noted before, we are making good progress on our research and development effort, particularly in the CNS operating area and our NTE portfolio.
正如 Jeremy 之前指出的那樣,我們在研發方面取得了良好進展,特別是在 CNS 運營領域和 NTE 產品組合方面。
All these moves were reflected this quarter in an increase of 13% year over year and our non-GAAP net R&D expenses, which totaled $329 million this quarter, or 6.7% of revenues.
所有這些舉措都反映在本季度同比增長 13% 以及我們的非 GAAP 淨研發費用,本季度總計 3.29 億美元,佔收入的 6.7%。
Our non-GAAP selling and marketing expenses totaled $985 million, or 20.1% of revenues in the quarter, a 7.5% increase compared to $916 million, or 18% of revenues in the first quarter of 2012.
我們的非 GAAP 銷售和營銷費用總計 9.85 億美元,佔本季度收入的 20.1%,與 2012 年第一季度的 9.16 億美元(佔收入的 18%)相比增長 7.5%。
The increase was primarily due to higher expenses of specialty medicines, higher OTC investments and assumption of distribution and marketing responsibility for Copaxone in Europe, as well as a modest increase in royalty payments, which were still lower than our plan.
增加的主要原因是特種藥物費用增加、非處方藥投資增加、承擔了 Copaxone 在歐洲的分銷和營銷責任,以及特許權使用費略有增加,但仍低於我們的計劃。
G&A expenses totaled $307 million in the quarter, or 6.3% of revenue, a small decrease in spend compared to the first quarter of 2012.
本季度 G&A 費用總計 3.07 億美元,佔收入的 6.3%,與 2012 年第一季度相比支出略有下降。
The overall split of operating profit before G&A expenses between our main lines of business for the quarter is as follows, low generic, 21%; multiple sclerosis, 52%; other specialty brands, 23%; OTC and other businesses, 4%.
本季度我們主要業務線之間扣除 G&A 費用前營業利潤的總體分配如下,低通用,21%;多發性硬化症,52%;其他專業品牌,23%; OTC及其他業務,4%。
We recorded $81 million of financial expenses on non-GAAP basis in the first quarter compared to $70 million in the comparable quarter of 2012.
我們在第一季度記錄了 8100 萬美元的非 GAAP 財務費用,而 2012 年同期為 7000 萬美元。
This is mostly the result of higher interest expenses we are paying following the extension of our debt maturity profile, in line with our new strategy and of higher expenses in connection with our hedging activities in the first quarter of 2013.
這主要是由於我們根據新戰略延長債務期限後支付的利息費用增加,以及與 2013 年第一季度對沖活動相關的費用增加。
The provisions for non-GAAP tax in the first quarter of 2013 was 16.5% and amounted to $193 million of pretax non-GAAP income of $1.2 billion.
2013 年第一季度的非 GAAP 稅收準備金為 16.5%,稅前非 GAAP 收入為 12 億美元,為 1.93 億美元。
This compares to 13.7% or $207 million in pre-tax non-GAAP income of $1.5 billion in the first quarter of 2012.
相比之下,2012 年第一季度 15 億美元的稅前非公認會計原則收入為 13.7% 或 2.07 億美元。
We do expect our tax to go down later in the year.
我們確實希望我們的稅收在今年晚些時候下降。
Overall tax rates in 2013 will be higher than in 2012, given the different mix of products and geographies.
鑑於產品和地域的不同組合,2013 年的總體稅率將高於 2012 年。
Cash flow from operations in the first quarter was a solid $1.1 billion, an increase of 46% compared to the first quarter of 2012, mostly reflecting better management of our working capital.
第一季度運營產生的現金流量為 11 億美元,比 2012 年第一季度增長 46%,主要反映了我們對營運資金的更好管理。
Free cash flow, which excludes capital expenditures and dividends, also increased well this quarter by 55% to $640 million.
不包括資本支出和股息的自由現金流在本季度也增長了 55%,達到 6.4 億美元。
We are continuing to take advantage of our solid cash flow to reduce our level of debt.
我們將繼續利用穩健的現金流來降低債務水平。
This quarter we repaid a total of $1.8 billion of debt, consisting of three separate debt repayments.
本季度我們共償還了 18 億美元的債務,包括三筆單獨的債務償還。
As a result, our financial leverage decreased from 39% to 36% quarter over quarter.
因此,我們的財務槓桿比上一季度從 39% 下降到 36%。
At the same time, our cash and marketable securities decreased from $3.1 billion to $1.6 billion.
與此同時,我們的現金和有價證券從 31 億美元減少到 16 億美元。
As we committed on doing, we will continue to allocate our cash in a disciplined manner to support our strategy, reward our shareholders and also service our debt.
正如我們承諾的那樣,我們將繼續以有紀律的方式分配我們的現金,以支持我們的戰略、回報我們的股東並償還我們的債務。
During the quarter we repurchased approximately 5.2 million shares for an aggregate cost of approximately $200 million.
本季度,我們回購了大約 520 萬股股票,總成本約為 2 億美元。
With the dividend paid this quarter, we returned an aggregate amount of $481 million to our shareholders, or approximately 44% of our quarterly cash flow from operation.
通過本季度支付的股息,我們向股東返還了總計 4.81 億美元,約占我們季度運營現金流的 44%。
In line with the increase of our quarterly dividend announced last quarter, our Board has approved a quarterly dividend for the first quarter of ILS1.15 per share.
為配合我們上季度宣布的季度股息增加,我們的董事會已批准第一季度每股 ILS1.15 的季度股息。
Based on the exchange rate on April 30, 2013 of the shekel to the US dollar, this translates into approximately $0.32 per share, or a total amount of $272 million.
根據 2013 年 4 月 30 日謝克爾對美元的匯率,這相當於每股約 0.32 美元,或總額為 2.72 億美元。
Looking forward to the rest of 2013 we are reiterating our guidance for revenues of between $19.5 billion and $20.5 billion and non-GAAP diluted earnings per share of $4.85 to $5.15.
展望 2013 年的剩餘時間,我們重申我們對 195 億美元至 205 億美元的收入和 4.85 美元至 5.15 美元的非 GAAP 攤薄每股收益的指導。
We do want, however, to turn your attention to an important point.
但是,我們確實希望將您的注意力轉移到重要的一點上。
As we have previously stated to you, our original projection of 2013 did not assume additional generic competition in the US for budesonide, the generic equivalent of AstraZeneca's Pulmicort.
正如我們之前向您聲明的那樣,我們對 2013 年的最初預測並未假設在美國對布地奈德(阿斯利康的 Pulmicort 的仿製藥等同物)進行額外的仿製藥競爭。
As the decision and the pending litigation concerning this medicine is currently pending an appeal process with the US court, it is still early to tell whether we will indeed see such additional generic competition in the market during 2013 or not.
由於有關該藥物的決定和未決訴訟目前正在等待美國法院的上訴程序,因此現在判斷我們是否真的會在 2013 年期間在市場上看到此類額外的仿製藥競爭還為時過早。
If we were to see additional generic competition enter the market this year, this will impact our results, especially the result of the second quarter if the decision is rendered in the second quarter.
如果今年我們看到更多的仿製藥競爭進入市場,這將影響我們的業績,特別是如果在第二季度做出決定的話,第二季度的業績。
But we believe that this will not change our original guidance ranges.
但我們相信這不會改變我們原來的指導範圍。
We will obviously continue to update you, as this matter continues to unfold.
隨著此事的繼續發展,我們顯然會繼續向您更新。
This concludes my prepared remarks.
我準備好的發言到此結束。
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 open the call for Q&A.
我現在想打開問答環節。
Operator
Operator
Thank you.
謝謝你。
We will now begin the question and answer session.
我們現在開始問答環節。
(Operator instructions)
(操作員說明)
Please be aware you are limited to one question and one follow-up question, due to the interest of time.
請注意,由於時間關係,您只能回答一個問題和一個後續問題。
Jason Gerberry, Leerink Swann.
Jason Gerberry,Leerink Swann。
- Analyst
- Analyst
Hello, guys, actually Chris Heanley in for Jason Gerberry.
大家好,實際上是克里斯·希恩利 (Chris Heanley) 代替傑森·格伯里 (Jason Gerberry)。
Thanks for taking the question.
感謝您提出問題。
Quick one on OTC.
快速在場外交易。
How should we be thinking about that run rate going forward?
我們應該如何考慮未來的運行率?
Is this quarter representative of future quarters?
這個季度代表未來的季度嗎?
- President and CEO
- President and CEO
Jason, this is Jeremy.
傑森,這是傑里米。
Thank you very much for your question on OTC.
非常感謝您對 OTC 的提問。
I had a little difficulty hearing you, but I think what you are asking for, and I'll just repeat the question, was looking at the OTC, how do we look at this as a run rate going forward is that correct?
我聽到你的聲音有點困難,但我想你要求的是看場外交易,我們如何看待它作為未來的運行率是正確的嗎?
- Analyst
- Analyst
That's correct.
這是正確的。
- President and CEO
- President and CEO
Okay.
好的。
Eyal, would you take that question please?
Eyal,你能回答這個問題嗎?
- CFO
- CFO
Sure.
當然。
Thanks, Jason.
謝謝,傑森。
First of all, the numbers are nice.
首先,數字很好。
We see the improvement from one quarter to the other.
我們看到一個季度到另一個季度的改善。
We have to remember that Q1 is a winter quarter and has seasonal impact dependent on flu season, because these are the type of medicine of some of the OTC that we sell.
我們必須記住,第一季度是冬季,季節性影響取決於流感季節,因為這些是我們銷售的一些非處方藥的藥物類型。
We do expect our OTC businesses to continue to grow double-digit year over year.
我們確實預計我們的場外交易業務將繼續以兩位數的速度同比增長。
- Analyst
- Analyst
Great thank you.
太好了謝謝。
And actually, if I could just slip in one on Lovaza, that would seem to be some major upside to your US numbers if you get favorable appellate ruling.
事實上,如果我能在 Lovaza 上加入一個,如果你獲得有利的上訴裁決,那似乎對你的美國數字有一些重大的好處。
Can you guys quickly address a readiness to launch on that product?
你們能快速解決在該產品上發布的準備情況嗎?
I think what we'd like to do there, Jason, is get back to you on that one if you don't mind.
Jason,我想我們想做的是,如果你不介意的話,就那個問題回复你。
We do think there is upside there, but we need to be cautious about what we say about that, without talking to our partners on that.
我們確實認為那裡有好處,但我們需要對我們所說的保持謹慎,而不是與我們的合作夥伴就此進行交談。
Okay, great, thank you.
好的,太好了,謝謝。
Operator
Operator
Randall Stanicky, Canaccord.
蘭德爾·斯坦尼基,Canaccord。
- Analyst
- Analyst
Hello, guys, thanks.
大家好,謝謝。
Two questions.
兩個問題。
One for Eyal and one for Jeremy.
一份給 Eyal,一份給 Jeremy。
Eyal, relative to spending, it was down sequentially.
Eyal,相對於支出,它連續下降。
We expected it to be flat both on the R&D and SG&A side.
我們預計它在研發和 SG&A 方面都將持平。
Can you talk about that?
你能談談嗎?
And then how do we think about the trend going forward?
那麼我們如何看待未來的趨勢呢?
Is the Q1 spend number the right run rate?
Q1 支出數字是正確的運行率嗎?
And then I've got one follow-up for Jeremy.
然後我有一個傑里米的後續行動。
- CFO
- CFO
Okay.
好的。
What we see is increasing R&D spend throughout the year.
我們看到全年的研發支出都在增加。
We started the year a little slower.
我們今年開局有點慢。
We will most likely catch up on the expenses.
我們很可能會趕上開支。
Sales increased very modest in sales and marketing, and probably flat on G&A.
銷售和營銷的銷售額增長非常溫和,一般和行政費用可能持平。
This is the G&A run rate we'll see throughout the year.
這是我們將在全年看到的 G&A 運行率。
- Analyst
- Analyst
But the major cost cuts that we should be thinking about relative to your targeted savings, that's not really going to hit in the back half.
但是,相對於您的目標節省,我們應該考慮的主要成本削減並不會真正影響到後半部分。
Should we be thinking about early '14 or can we see some of that start to flow through earlier?
我們應該考慮 14 年初,還是我們可以看到其中一些更早開始流動?
- CFO
- CFO
The majority of our cost saving is part of the reshape program we will start to unfold in 2014 and 2015.
我們節省的大部分成本是我們將在 2014 年和 2015 年開始展開的重塑計劃的一部分。
We have very small amount of that in our plan for 2013, mostly the second half as we are moving forward in preparation for all that.
我們在 2013 年的計劃中只有很少的一部分,主要是下半年,因為我們正在為所有這些做準備。
- Analyst
- Analyst
Okay.
好的。
And Jeremy, on the NTE program, there is obviously a lot of focus on the revenue side of the business.
傑里米,在 NTE 計劃中,顯然非常關注業務的收入方面。
The opportunity there via 505V2 is to bring some opportunities in earlier.
via 505V2那裡的機會是為了更早帶來一些機會。
Can you just talk to us about what should we think about for timing?
能不能跟我們談談我們在時機上應該考慮什麼?
We don't have a lot of visibility into the pipeline there.
我們對那裡的管道沒有太多的了解。
How quickly can you bring some of those to market?
您能多快將其中一些產品推向市場?
And then, as we think of (inaudible) sales potential, Are these products in the range of 200 to $400 million or potentially more?
然後,當我們考慮(聽不清)銷售潛力時,這些產品是否在 200 到 4 億美元或可能更多的範圍內?
Is there some color that you could help us with there?
有什麼顏色可以幫助我們嗎?
Thank you.
謝謝你。
- President and CEO
- President and CEO
Hello, Randall.
你好,蘭德爾。
There's a couple of things.
有幾件事。
Michael can talk a little bit more on it.
邁克爾可以就此多談一點。
First of all, we view this overall as a multi-billion dollar opportunity.
首先,我們認為這總體上是一個數十億美元的機會。
There are examples of this in the past where individual products, which are would be described today as an NTE, have been highly successful.
過去有這樣的例子,今天被描述為 NTE 的個別產品已經非常成功。
So we are very keen on this.
所以我們非常熱衷於此。
With regard to timing, remember what we're doing here is, we're really handling this on two fronts.
關於時間安排,請記住我們在這裡所做的是,我們實際上是在兩個方面處理這個問題。
One, internal development, which is in the hands of Michael, and he will talk to you about that.
第一,內部發展,由 Michael 負責,他會與您討論。
Secondly, in terms of business development, at this stage, Randall, you should know that we are getting an absolute flood of tremendous opportunities in this area, some of which could be launched as early as this year, some of which could be launched later.
其次,在業務發展方面,在現階段,蘭德爾,你應該知道我們在這一領域獲得了絕對的巨大機會,其中一些最早可以在今年推出,一些可能會在今年推出.
Frankly the opportunities are coming out and are showing us are extremely attractive.
坦率地說,機會正在出現,並向我們展示了極具吸引力。
We are wading through them.
我們正在涉水通過他們。
Picking them very, very, very carefully.
非常、非常、非常仔細地挑選它們。
And perhaps, Michael, you'd make a couple comments on this.
也許,邁克爾,你會對此發表一些評論。
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Thank you, Randall.
謝謝你,蘭德爾。
We are making great progress in our NTE portfolio.
我們在 NTE 產品組合方面取得了很大進展。
You have got to resolve these as, sometimes, as late stage Phase III products.
你必須解決這些,有時,作為晚期 III 期產品。
In other words, the likely development time for them is up to three years, some of them do not have to go through clinical trials at all, just need to show by equivalence.
也就是說,它們的研發時間可能長達三年,其中一些根本不需要經過臨床試驗,只需要通過等效性來證明即可。
And so with 13, between 10 and 13, we think around 13 approved for development this year, that is like having 13 new Phase III products in your pipeline.
因此,有 13 個,在 10 到 13 個之間,我們認為今年大約有 13 個獲准開發,這就像您的管道中有 13 個新的 III 期產品。
We expect some of these to actually get to the market within the next few years and this will continue to grow, year by year.
我們預計其中一些將在未來幾年內真正進入市場,而且這一數字將逐年繼續增長。
So it's 13 new products in your pipeline every single year going forward.
因此,未來每年都有 13 種新產品在您的管道中。
- Analyst
- Analyst
Great, thanks, guys.
太好了,謝謝,伙計們。
Operator
Operator
Jami Rubin, Goldman Sachs.
賈米魯賓,高盛。
- Analyst
- Analyst
Thank you, just a couple of questions.
謝謝,只是幾個問題。
First, Eyal, if you could address what is happening in the US generics business.
首先,Eyal,請問您能否談談美國仿製藥行業正在發生的事情。
That came in below our expectations and that of consensus.
這低於我們的預期和共識。
Obviously, maybe there are seasonality issues that affect comparisons.
顯然,可能存在影響比較的季節性問題。
If you could talk about that business, how we should think about it going forward.
如果你能談談那項業務,我們應該如何考慮它的發展。
What are the key drivers that you have in the ANDA pipeline we could be looking towards?
在我們可以期待的 ANDA 管道中,您有哪些關鍵驅動因素?
Secondly, not sure who can address this, but curious to know your confidence level in the FDA's ability to approve EpiPen, an AB-rated EpiPen in 2015.
其次,不確定誰可以解決這個問題,但很想知道您對 FDA 在 2015 年批准 EpiPen 的能力的信心水平,這是一種 AB 級的 EpiPen。
Thanks.
謝謝。
- President and CEO
- President and CEO
Jami, hello, it's Jeremy here.
傑米,你好,我是傑里米。
We have actually got Allan on the line so he can address the question on the North American generics.
實際上,我們已讓 Allan 在線,以便他可以解決有關北美仿製藥的問題。
Why don't we hand over to him and then we'll come back.
為什麼我們不交給他,然後我們再回來。
- President and CEO of Teva America Generics
- President and CEO of Teva America Generics
Great, super.
太棒了,超級棒。
Thank you, Jamie, for the question.
傑米,謝謝你提出這個問題。
When we think about the US Generics business in Q1, it was actually in line with our expectations of where we thought it would come out, in spite of the fact, clearly, as Eyal said, it was challenging.
當我們考慮第一季度的美國仿製藥業務時,它實際上符合我們對其預期結果的預期,儘管事實上,正如 Eyal 所說,這顯然具有挑戰性。
Our year-over-year comparison was a challenging comparison.
我們的年度比較是一個具有挑戰性的比較。
Last year we had our agreement with Ranbaxy on the generic equivalent of Lipitor, atorvastatin, that benefited us.
去年,我們與 Ranbaxy 就立普妥的仿製藥阿托伐他汀達成了協議,這使我們受益。
We had exclusivity on Lexapro, or escitalopram, which benefited us last year.
我們對 Lexapro 或艾司西酞普蘭擁有排他性,這在去年使我們受益。
And this year we saw price erosion on Zyprexa, Olanzapine and Adderall XR mixed amphetamine salts.
今年我們看到再普樂、奧氮平和 Adderall XR 混合苯丙胺鹽的價格下跌。
So it was a very tough year-over-year comparison, all of which was factored in to what our expectations were for the quarter.
因此,這是一個非常艱難的同比比較,所有這些都考慮到了我們對本季度的預期。
As we look at subsequent quarters going forward, we see a continued improvement quarter over quarter, and the continued strengthening of the generics business here in the US.
展望未來幾個季度,我們看到季度環比持續改善,美國仿製藥業務持續加強。
I would point out a couple of things.
我要指出幾件事。
One, as Eyal mentioned in his prepared comments, the uncertainty relative to the court's ultimate decision on Pulmicort and budesonide on one hand, and on the other hand, as I think I said in the last quarterly call, in 2012 we launched 23 products representing a brand value of about $27 billion.
其一,正如 Eyal 在他準備好的評論中提到的,一方面法院對 Pulmicort 和布地奈德的最終決定的不確定性,另一方面,正如我想我在上一個季度電話會議中所說的那樣,2012 年我們推出了 23 種產品代表品牌價值約為 270 億美元。
We forecast a similar number of new launches in 2013.
我們預計 2013 年將推出類似數量的新品。
We launched three of them in Q1, brand value of a little over $400 million.
我們在第一季度推出了其中三款,品牌價值略高於 4 億美元。
You can see we have new product upside as the year continues to unfold.
隨著這一年的繼續展開,您可以看到我們有新產品的優勢。
We have also seen steady improvements in our service levels we provide to our customers.
我們還看到我們為客戶提供的服務水平穩步提高。
I can say our customers certainly are recognizing us in our ability to supply them, which is resulting in additional customer awards coming our way.
我可以說,我們的客戶肯定認可我們供應他們的能力,這導致我們獲得了額外的客戶獎項。
And finally, recognized through a recent award we received from Wal-Mart as the Wal-Mart pharmacy partner of the year, because of our partnership agreement with them and our ability to supply.
最後,由於我們與他們的合作協議以及我們的供應能力,我們最近從沃爾瑪獲得了一個獎項,被認可為年度沃爾瑪藥房合作夥伴。
So I think that gives you a good framework of where Q1 was relative to US generics and where the rest of the year looks like it may unfold.
因此,我認為這為您提供了一個很好的框架,說明第一季度相對於美國仿製藥的位置,以及今年餘下時間可能展開的情況。
- President and CEO
- President and CEO
Jamie, your question on the EpiPen, I'll let you know we have a settlement with Mylan and we have an entry date in 2015.
傑米,你關於 EpiPen 的問題,我會告訴你我們與 Mylan 達成了和解,我們的進入日期是 2015 年。
The file is progressing well.
文件進展順利。
Operator
Operator
David Risinger, Morgan Stanley.
大衛瑞辛格,摩根士丹利。
- Analyst
- Analyst
Yes, thank you very much.
是的謝謝你。
I have a couple of questions.
我有一些問題。
First, and I'll actually make it three, if that's okay.
首先,如果可以的話,我實際上會做到三個。
Pulmicort, could you just frame for us the US revenue and EPS contributions so that we know the swing factor if you do end up with greater competition?
Pulmicort,你能否為我們列出美國的收入和每股收益貢獻,以便我們知道如果你最終面臨更大的競爭,搖擺因素?
Second, could you speak to the growth outlook for Rest of World?
其次,您能談談世界其他地區的增長前景嗎?
It was weaker than expected this quarter.
本季度低於預期。
Just wondering how to think about growth prospects going forward in Rest of World.
只是想知道如何思考世界其他地區未來的增長前景。
And then, third, for the three times a week Copaxone, have you filed that and can you provide a filing update?
然後,第三,對於每週三次的 Copaxone,你提交了嗎?你能提供提交更新嗎?
Thank you.
謝謝你。
- President and CEO
- President and CEO
Hello, David, there is a lot of people in line, so we'll try to keep the answers short and crisp.
你好,大衛,排隊的人很多,所以我們會盡量讓答案簡短明了。
The first two Pulmicort, I think what we'll do, Allan, why don't you handle that?
前兩個 Pulmicort,我想我們會做什麼,Allan,你為什麼不處理它?
And gross outlook for the Rest of the World, Eyal will handle that.
對於世界其他地區的總體前景,Eyal 將負責處理。
And if we've got time, depending on how rapidly this goes, we'll hand over to John Connelton or Michael, here, can talk about the three times a week.
如果我們有時間,取決於進展的速度,我們將交給 John Connelton 或 Michael,在這裡,可以談論每週三次。
Why don't we start with Allan?
我們為什麼不從艾倫開始呢?
- President and CEO of Teva America Generics
- President and CEO of Teva America Generics
Thank you David.
謝謝大衛。
With regards to your question on Pulmicort, we don't specifically break out individual products within our portfolio.
關於您關於 Pulmicort 的問題,我們不會具體分解我們產品組合中的個別產品。
But we have said that Pulmicort, or generic budesonide, is the largest product within our portfolio.
但我們已經說過,普米克或通用布地奈德是我們產品組合中最大的產品。
And depending on which way it goes, we continue to have no competition factored into the forecast.
根據它的發展方向,我們繼續沒有將競爭因素納入預測。
Although again I would reiterate that the guidance that we've given on the US Generics business of $4.3 billion to $4.7 billion for the year, incorporates budesonide or Pulmicort.
儘管我要再次重申,我們對今年 43 億美元至 47 億美元的美國仿製藥業務給出的指導包括布地奈德或普米克。
If it remains semi-exclusive with us, clearly we'd be in the mid to high end of that range.
如果它對我們保持半排他性,顯然我們將處於該範圍的中高端。
If we find ourselves with additional competitors we'll be at the low end or slightly below the low end of that range.
如果我們發現自己有更多的競爭對手,我們將處於該範圍的低端或略低於該範圍的低端。
That is the way you should envision what Pulmicort, the impact it has on the US Generics business.
這就是您應該設想什麼 Pulmicort 及其對美國仿製藥業務的影響的方式。
- CFO
- CFO
All right, David, hello, it's Eyal.
好的,大衛,你好,我是埃亞爾。
Regarding the Rest of the World, without too many details, there are two factors that impacted our Rest of the World businesses quarter, which need to be analyzed under this too.
關於世界其他地區,沒有太多細節,有兩個因素影響了我們的世界其他地區業務季度,這也需要在此進行分析。
The first is exchange rates.
首先是匯率。
Especially in Japan, the Japanese yen is about 22%, 23% compared to where it was almost a quarter ago.
尤其是在日本,日元匯率約為 22%,與將近一個季度前相比上漲了 23%。
Some currencies in Latin America had an impact on sales, because if you look at our Generic business it actually grew, and basically the impact of the exchange rate if they remain where they are, will continue to slide into next quarter, but in local currencies we are generating growth in all of these markets.
拉丁美洲的一些貨幣對銷售產生了影響,因為如果你看一下我們的仿製藥業務,它實際上是在增長的,基本上匯率的影響如果保持不變,將繼續下滑到下個季度,但以當地貨幣計算我們正在所有這些市場中創造增長。
The Specialty part actually suffered from the lack of Copaxone tender pressure, which we had in first quarter last year, and that is, of course missing in the comparison.
專業部分實際上遭受了我們去年第一季度缺乏 Copaxone 招標壓力的影響,也就是說,在比較中當然沒有了。
We expect to have sales later on this year but it depends on the timing of the tender.
我們預計將在今年晚些時候進行銷售,但這取決於招標的時間。
These were the two major factors, exchange rate was the main one.
這是兩個主要因素,匯率是主要因素。
- President and CEO
- President and CEO
Then with regard to Copaxone, Michael you are here, why don't you deal with that?
那麼關於 Copaxone,邁克爾,你在這裡,你為什麼不處理它?
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Thank you, David.
謝謝你,大衛。
Our FNDA was submitted on time as planned to the FDA March 29.
我們的 FNDA 已按計劃於 3 月 29 日按時提交給 FDA。
We are hopeful that this product will be approved and ready for commercialization early 2014.
我們希望該產品能夠在 2014 年初獲得批准並準備好商業化。
In addition we are assuming approval for Copaxone in Europe and expect to submit that for approval this quarter.
此外,我們假設 Copaxone 在歐洲獲得批准,並預計將在本季度提交批准。
Operator
Operator
David Maris, BMO.
大衛·馬里斯,BMO。
- Analyst
- Analyst
Morning.
早晨。
Two questions.
兩個問題。
First, Michael, on XEN402.
首先,邁克爾,在 XEN402 上。
Congrats on the orphan drug status.
祝賀孤兒藥地位。
What other indications do you think this drug could be applicable for and how are you pursuing them?
您認為這種藥物還適用於哪些其他適應症,您將如何研究這些適應症?
And then separately, more broadly for Eyal and Jeremy, I know you are both frustrated, as a number of people are, with the stock price and you can't manage the stock price.
然後分別,更廣泛地說,對於 Eyal 和 Jeremy,我知道你們都和許多人一樣對股價感到沮喪,而且你們無法管理股價。
But in your discussions with investors, what do you think, what's most misunderstood?
但在你與投資者的討論中,你怎麼看,最容易被誤解的是什麼?
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Thank you, David.
謝謝你,大衛。
Nice to have you on the line.
很高興你在線。
For XEN402, we see both very focused open indications as well as a quite broad indications.
對於 XEN402,我們既看到了非常集中的開放跡象,也看到了相當廣泛的跡象。
So for the open indication, of course, erythromelalgia, actually this is not such a small market, because the world's seeing bulge small more type in neuropathy and this is quite significant.
因此,對於開放適應症,當然,紅斑性肢痛症,實際上這不是一個小市場,因為世界上更多的神經病類型正在發生,這非常重要。
The important thing for XEN402, particularly the topical, you get great absorption through the skin, and we also, for example, straight to the joint capsule, and we will be also initiating trials this year as in various forms of arthritis, particularly affecting the lower limbs and this market is profoundly huge.
XEN402 的重要之處在於,特別是外用,你可以通過皮膚很好地吸收,例如,我們也直接進入關節囊,我們今年也將開始試驗各種形式的關節炎,特別是影響下肢這個市場極其巨大。
So we see both a focused market in terms of alternate indications and also extension from there and then inflammatory indications for our sale prices, for example.
因此,我們既看到了替代適應症方面的重點市場,也看到了從那裡延伸的市場,然後是我們銷售價格的煽動性跡象。
- President and CEO
- President and CEO
David, I'll take this actually quickly.
大衛,我很快就會接受這個。
Good to chat with you on the phone.
很高興通過電話與您聊天。
A couple of things, look, we have spoken to a lot of investors.
有幾件事,看,我們已經和很多投資者談過。
Some have expressed deep support and others who are having significant views with some of the purchases of the stock.
一些人表示了大力支持,而另一些人則對部分股票購買持重要看法。
And there is an overall change in the portfolio of the types of people who are holding it.
持有它的人的投資組合發生了全面變化。
All of this is a reflection of some change that's gone on.
所有這一切都反映了一些正在發生的變化。
A couple of things I think have underpinned what you are describing.
我認為有幾件事支持了你所描述的內容。
Number one, this is a sophisticated Company that is undergoing significant change.
第一,這是一家成熟的公司,正在經歷重大變革。
It's a Company with great potential, a Company that's got a real future.
這是一家具有巨大潛力的公司,一家擁有真正未來的公司。
And it is very difficult for people to look back and understand that you walk away from a, essentially, a top-line driven strategy, driven by acquisitions coupled with, essentially, full of exclusivity, which no longer play a major role in our overall strength.
人們很難回過頭來理解你放棄了一個基本上是頂線驅動的戰略,由收購驅動,加上基本上充滿排他性,這在我們的整體中不再發揮主要作用力量。
It's difficult for them to understand allow the sophisticated strategy that we now have laid in place, which is a growth strategy agree with significant pillars related to the ones I have described, and an integrated business plan, coupled now with a clear organizational structure and top-line people who are now running this.
他們很難理解我們現在已經制定的複雜戰略,這是一個與我所描述的戰略相關的重要支柱一致的增長戰略,以及一個綜合業務計劃,現在加上清晰的組織結構和高層-現在正在運行這個的在線人員。
Difficult to look at that, and I think that quite rightly, investors are looking for milestones and evidence that perhaps we're executing.
很難看,我認為這是正確的,投資者正在尋找我們可能正在執行的里程碑和證據。
There is little doubt in my mind, and for those in the Company, and externally those who know as well, that we are absolutely executing.
在我看來,對於公司內部的人以及外部那些知道的人來說,毫無疑問,我們絕對在執行。
So I look forward this year, very much, as we start rolling out aggressively, you'll see the execution that people expect, and quite rightly so.
所以我非常期待今年,當我們開始積極推出時,你會看到人們期望的執行,這是正確的。
Operator
Operator
Chris Schott, JP Morgan.
摩根大通的克里斯肖特。
- Analyst
- Analyst
Thanks, it is actually Jessica Fye on for Chris.
謝謝,實際上是 Jessica Fye 代替了 Chris。
Looks like Copaxone had a very strong quarter in the US.
看起來 Copaxone 在美國的季度表現非常強勁。
Can you talk a little bit about the volume trends you've have been seeing since launch of BG-12 and also any initial feedback you are hearing in the market on that launch?
您能否談談自 BG-12 發布以來您所看到的銷量趨勢,以及您在市場上聽到的有關該發布的任何初步反饋?
- President and CEO
- President and CEO
Hello, Jess, it's Jeremy here.
你好,傑西,我是傑里米。
I think what we'll do is we'll start with John on that, if that's okay.
我想我們要做的是從 John 開始,如果可以的話。
John, as you know, is now running our entire MS franchise and working with Rob in the new Global Specialty Medicines organization.
如您所知,John 現在負責管理我們的整個 MS 特許經營權,並與 Rob 在新的 Global Specialty Medicines 組織中合作。
John, why don't you take that?
約翰,你為什麼不接受它?
John's also got a history of having dealt with Copaxone for many, many years.
約翰也有多年與 Copaxone 打交道的歷史。
- SVP of Global Medicines
- SVP of Global Medicines
Jessica, this is John, thank you for the question.
傑西卡,我是約翰,謝謝你的提問。
As you heard Jeremy talk the quarterly figures look very strong, the units globally are up on Copaxone quarter relative to prior years.
正如你聽到 Jeremy 所說的那樣,季度數據看起來非常強勁,與往年相比,全球單位在 Copaxone 季度有所增加。
We are very pleased with what continues there.
我們對那裡的發展感到非常滿意。
As far as the volume trends relative to fumarate, it is still really early to tell.
至於富馬酸鹽的體積趨勢,現在下結論還為時過早。
We have three weeks worth of data.
我們有三週的數據。
What we are hearing in the marketplace is continued support for Copaxone and the profile that it provides, really the unsurpassed efficacy, safety and tolerability that has been seen over 17 years experience with this product, is what is still resonating in the marketplace.
我們在市場上聽到的是對 Copaxone 的持續支持及其提供的配置文件,真正無與倫比的療效、安全性和耐受性,在 17 年的使用該產品的經驗中,仍然在市場上引起共鳴。
You tend to see, not only with Copaxone, but even the interferons that still continue to have business, that there's a lot of stability when patients and physicians find medication that works for them, they tend to say with that.
你往往會看到,不僅是 Copaxone,甚至是仍在繼續開展業務的干擾素,當患者和醫生找到對他們有效的藥物時,他們往往會這樣說,穩定性很高。
It will be interesting to see, and it will take several months, what kind of disposition is occurring with fumerate and some of the other orals, but I don't think anything is surprising us at this point, and we are not seeing any significant changes in volume in the short-term weeklies.
看到 fumerate 和其他一些口服藥發生什麼樣的處置將會很有趣,這將需要幾個月的時間,但我認為目前沒有任何事情讓我們感到驚訝,我們也沒有看到任何重要的短期週線的成交量變化。
- Analyst
- Analyst
Thanks.
謝謝。
Operator
Operator
The next question is from Mark --
下一個問題來自馬克——
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Ah --
啊——
Operator
Operator
I'm sorry, please go ahead.
對不起,請繼續。
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Yes, I want to add to that.
是的,我想補充一點。
It's Michael here, to provide greater perspective on that.
我是 Michael,他將就此提供更廣闊的視角。
Of course Teva remains a supporter of the need to treat the managed MS. We welcome new therapy.
當然,Teva 仍然支持治療管理型 MS 的需要。我們歡迎新療法。
And of course, with any new therapy like fumerates, there is a level of interest that's mitigated by the uncertainty.
當然,對於像 fumerates 這樣的任何新療法,不確定性都會降低一定程度的興趣。
And in the case of fumerates, the issue, of course, that's on many people's minds is the very minimal long-term exposure, and all of that in trial settings.
就富馬酸鹽而言,當然,很多人都在考慮的問題是長期暴露在極低限度的情況下,而且所有這些都是在試驗環境中進行的。
I think now with the April 21 data out from the New England Journal on the PML, this has raised concerns about this particular drug and its relationship to long-term side effects.
我認為,隨著 4 月 21 日《新英格蘭雜誌》關於 PML 的數據的出現,這引起了人們對這種特殊藥物及其與長期副作用的關係的擔憂。
It is important to know, even though the manuscript in the New England Journal had different forms of fumerates leading to PML, it is important to note that with DMS, dimethyl sulfide, all of these compounds have the same active compound, there is nothing else in it and the same with this.
重要的是要知道,即使新英格蘭雜誌的手稿中有不同形式的富馬酸鹽導致 PML,重要的是要注意,對於 DMS,二甲基硫醚,所有這些化合物都具有相同的活性化合物,沒有別的在裡面和這個一樣。
So I think the, we have to see, of course long-term clinical experience is needed.
所以我認為,我們必須看到,當然需要長期的臨床經驗。
And so we await that data as it comes out.
所以我們等待數據出來。
Operator
Operator
Mark Goodman from UBS.
來自瑞銀的馬克古德曼。
Mark your line is now open for a question.
標記您的線路現在可以提問。
If your phone is on mute, please unmute it.
如果您的手機處於靜音狀態,請將其取消靜音。
We'll move onto the next question.
我們將進入下一個問題。
Gregg Gilbert, Bank of America.
格雷格吉爾伯特,美國銀行。
- Analyst
- Analyst
Hi.
你好。
I have two.
我有兩個。
My first one, Jeremy, other than executing on the strategies laid out on Investor Day, clearly you have some work to do there and some time, are you and the Board assessing other options to enhance shareholder value?
我的第一個,傑里米,除了執行投資者日制定的戰略外,顯然你還有一些工作要做,你和董事會是否正在評估其他選擇以提高股東價值?
Is everything pretty much on the table at this point?
現在一切都擺在桌面上了嗎?
And my second question may be for Eyal.
我的第二個問題可能是關於 Eyal 的。
Is the potential liability on pertonics something that need to play out before you and the team and the Board make significant decisions on cash deployment, such as the potential for another dividend increase or additional share buyback?
在您和團隊以及董事會就現金部署做出重大決定(例如可能再次增加股息或額外股票回購)之前,pertonics 的潛在責任是否需要解決?
Thanks.
謝謝。
- President and CEO
- President and CEO
Hello, Greg.
你好,格雷格。
No, I think you are right on the money.
不,我認為你是對的錢。
We are looking to enhance shareholder value at all stages.
我們希望在各個階段提高股東價值。
The Board is actively engaged in the capital allocation being part of this, how we think this through, how we utilize our capital, how we use all our elements within the Company to increase shareholder value.
董事會積極參與其中的資本分配,我們如何思考這個問題,我們如何利用我們的資本,我們如何利用公司內部的所有元素來增加股東價值。
You should understand that the strategy laid out in December is a strategy which is fundamental to the operations of the Company and are things that will play out over both the short, the mid and the long term.
你應該明白,12 月制定的戰略是公司運營的基礎戰略,是短期、中期和長期都會發揮作用的戰略。
That includes increasing our attention to how we increase shareholder value.
這包括增加我們對如何增加股東價值的關注。
- CFO
- CFO
Yes, regarding pertonics, first, we are all waiting for the court to decide on that.
是的,關於腹腔學,首先,我們都在等待法院對此做出決定。
We made in Q3 last year a significant provision of $670 million in our book.
去年第三季度,我們在賬簿中撥備了 6.7 億美元。
We do also have an insurance policy that covers any possible leverages, so we will await the legal process which will most likely go to appeal in any case.
我們也有涵蓋任何可能槓桿作用的保險政策,因此我們將等待在任何情況下最有可能上訴的法律程序。
Regarding buyback and dividends, we discussed it in our Board reviews on dividend every quarter, as opposed to every year in the past.
關於回購和股息,我們在董事會每季度對股息的審查中進行了討論,而不是過去每年一次。
We have continued to buy back shares this quarter.
本季度我們繼續回購股票。
We will continue with the buyback program, the three year buyback program and the Board will review dividends frequently.
我們將繼續實施回購計劃,三年期回購計劃,董事會將經常審查股息。
Just an indication, our dividend payment is increasing due to the -- it is in shekels, so due to the dollar and the shekel relationship, basically dividend in Q1 this year was 23% higher than dividend in Q1 last year, in dollar terms.
只是一個跡象,我們的股息支付正在增加,因為它是謝克爾,所以由於美元和謝克爾的關係,今年第一季度的股息基本上比去年第一季度的股息高出 23%,以美元計算。
- Analyst
- Analyst
Thanks.
謝謝。
Operator
Operator
Douglas Thale, Barclays.
道格拉斯·泰爾,巴克萊銀行。
Douglas your line is now open.
道格拉斯,您的線路現已開通。
If your phone is on mute, please unmute it.
如果您的手機處於靜音狀態,請將其取消靜音。
We will move on to the next question.
我們將繼續下一個問題。
Ronny Gal, Bernstein.
羅尼加爾,伯恩斯坦。
- Analyst
- Analyst
Good morning, thank you for taking my question.
早上好,謝謝你接受我的問題。
First question is around the Generic business.
第一個問題是關於通用業務的。
If I look at your numbers suggesting that 21% of the profits come from the generic business and subtract the Copax, which presumably is primarily related to the generic, you come to a number which is pretty close to break even.
如果我看一下你的數字表明 21% 的利潤來自仿製藥業務並減去 Copax,這可能主要與仿製藥有關,你會得到一個非常接近收支平衡的數字。
Taking out Pulmicort, it looks likes your Generic business is pretty close to break even.
除去 Pulmicort,看起來您的仿製藥業務非常接近收支平衡。
Jeremy, you have not really discussed a lot of strategy around the Generic business, primarily in the US and Western Europe.
傑里米,你並沒有真正討論過很多關於仿製藥業務的戰略,主要是在美國和西歐。
I was wondering if you can give us a few more words.
我想知道你是否可以再給我們說幾句話。
Are there significant plans to change how this business operates?
是否有重大計劃來改變該業務的運作方式?
Or is this business simply on an existing trajectory and we expect it would stay that way?
或者這項業務是否只是在現有的軌道上,我們希望它會保持這種狀態?
Second question is around the pipeline.
第二個問題是關於管道的。
Two quick ones, actually.
實際上,兩個快速的。
First, should we expect to see the laquinimod data for lupus in [UR]?
首先,我們是否應該期望在 [UR] 中看到狼瘡的 laquinimod 數據?
And second, is it fair to say that Treanda as a nitrogen mustard has enough side effects from being stored, the liquid formulation should be expected to be safer and more efficacious than the existing powder formulation?
其次,Treanda作為一種氮芥有足夠的儲存副作用,液體製劑應該比現有的粉末製劑更安全、更有效,這是否公平?
- President and CEO
- President and CEO
Hello, Ronny.
你好,羅尼。
Look, we have taken very aggressive steps on our businesses on both the EU and the US.
看,我們對我們在歐盟和美國的業務採取了非常積極的措施。
I think we should give you some color.
我想我們應該給你一些顏色。
We have been doing that along the way.
我們一直在這樣做。
But let me giver you over to the guys who've been running this.
但是讓我把你交給那些一直在運行這個的人。
First of all in Europe, Rob, why don't you give a quick response to this?
首先在歐洲,Rob,你為什麼不對此做出快速回應?
And secondly, Allan, why don't you take a quick look run at this from the US and Ronny gets a good picture.
其次,Allan,你為什麼不從美國快速看一下這個,Ronny 會得到一個很好的畫面。
And the what we'll have is Michael will touch the two questions that you had on the two products, laquinimod and Treanda.
我們將要回答的是,邁克爾將回答您對這兩種產品 laquinimod 和 Treanda 提出的兩個問題。
Rob?
搶?
- President and CEA of Global Specialty Medicines
- President and CEA of Global Specialty Medicines
Yes, happy to do it, Jeremy.
是的,很高興這樣做,傑里米。
On Europe, in Generics, what we see is actually a very nice growth both in sales and profitability, and I can assure you that really it is a profitable business.
在歐洲,在仿製藥中,我們看到的實際上是銷售額和盈利能力的非常好的增長,我可以向你保證,這確實是一個有利可圖的業務。
We are executing on our strategy of going for the right business which is sustainable profitable.
我們正在執行我們的戰略,即尋求可持續盈利的正確業務。
And we continue to be, and are very intent to stay, market leader in this in Europe and we have over-performed the market.
我們將繼續並且非常有意保持歐洲這一領域的市場領導者地位,並且我們的表現超過了市場。
But it's very much a profitable business in Europe, which is probably one of the more price-sensitive markets, per se, right?
但它在歐洲是一項非常有利可圖的業務,歐洲本身可能是對價格更敏感的市場之一,對吧?
And opportunities for generics continue to be there.
仿製藥的機會仍然存在。
Compared to the US, the generic market penetration is still low.
與美國相比,仿製藥市場滲透率仍然較低。
There are good opportunities, we see good growth in Italy and France, but we still can improve more.
有很好的機會,我們在意大利和法國看到了良好的增長,但我們仍然可以提高更多。
So we are well-positioned as well to capture some of the future growth there.
因此,我們也處於有利地位,可以抓住那裡的一些未來增長。
I'm actually quite optimistic for Generics, being in a difficult market like Europe.
我實際上對 Generics 非常樂觀,因為它處於像歐洲這樣困難的市場。
But we are delivering what is needed and we are increasing profitability.
但我們正在提供所需的東西,並且我們正在提高盈利能力。
- President and CEO
- President and CEO
Allan, you'll handle US, please?
艾倫,你會處理美國,好嗎?
- President and CEO of Teva America Generics
- President and CEO of Teva America Generics
Ronny, it's Allan.
羅尼,是艾倫。
Thanks for the question.
謝謝你的問題。
Let's start with the US market, certainly is a highly competitive market.
先從美國市場說起,肯定是一個競爭激烈的市場。
What we have been trying to do here is a multi-facetted strategy that we tried to lay out on December 11.
我們在這裡一直試圖做的是我們試圖在 12 月 11 日制定的多方面戰略。
Let's dig a little bit deeper into it perhaps today.
也許今天讓我們更深入地研究一下。
Certainly, as Jeremy has said, the historical number frequency and size of Paragraph IV opportunities have diminished with the addition of shared exclusivities.
當然,正如傑里米所說,隨著共享排他性的增加,第四段機會的歷史數量頻率和規模已經減少。
However we are still pursuing a strategy where we look to develop first, file first, get to market first and reap 181 days of exclusivity on a number products as we look to the future.
然而,我們仍然奉行一種戰略,即我們希望在展望未來時先開發、先申請、先上市,並在一些產品上獲得 181 天的獨家經營權。
Number two, Jeremy calls them high-value add, known as complex generics here in the US, where you marry a medicine and a device and you put it together, and you would anticipate significantly higher development costs, fewer competitors, and over the longer term a higher margin structure associated with that.
第二,Jeremy 稱它們為高附加值,在美國被稱為複雜仿製藥,您將一種藥物和一種設備結合在一起,然後將它們放在一起,您會預計開發成本會顯著增加,競爭對手會減少,而且會持續更長的時間術語與此相關的更高保證金結構。
Third, we talked about, I've talked about pricing.
第三,我們談到了,我已經談到了定價。
We have continued to aggressively take pricing, looking to lead the industry forward on products that are low-margin products to try and return a decent value to our Company, to our shareholders.
我們繼續積極定價,希望在低利潤產品方面引領行業發展,努力為我們的公司和股東回報可觀的價值。
And then there is a tail of products that we are working our way through in multiple dimensions.
然後是我們正在多個維度上努力完成的一系列產品。
First dimension is reformulating older products with lower cost, processes and APIs, in order to lower our cost and increase our margin, over time.
第一個維度是以更低的成本、流程和 API 重新配製舊產品,以隨著時間的推移降低我們的成本並增加我們的利潤。
Secondly, consistent with the announcement of Sellersville, moving our manufacturing east from higher cost manufacturing locations to lower cost manufacturing locations, will enhance value.
其次,與 Sellersville 的公告一致,將我們的製造業從成本較高的製造地點向東轉移到成本較低的製造地點,將提高價值。
And then finally, looking at the tail of products where we, after doing all of that, may not be able to enhance value long enough, finding other ways with other partners to create unique value add.
最後,看看產品的尾部,在完成所有這些之後,我們可能無法足夠長時間地提升價值,與其他合作夥伴一起尋找其他方式來創造獨特的附加值。
There is a whole host of activities we are doing to continue to progress the business forward, grow the top line and the profitability.
我們正在進行一系列活動,以繼續推動業務向前發展,增加收入和盈利能力。
Operator
Operator
Ken Cacciatore, Cowen and Company
Ken Cacciatore, Cowen and Company
- President and CEO
- President and CEO
-- I just want to answer Ronny's other two questions that he had quickly.
-- 我只想快速回答羅尼提出的另外兩個問題。
We are continuing to be encouraged by the unique immunomodulatory profile of laquinimod, we will be presenting that in clearly in June at [ULAR] as an oral presentation.
laquinimod 獨特的免疫調節特性繼續令我們感到鼓舞,我們將在 6 月的 [ULAR] 上以口頭報告的形式清楚地展示這一點。
And clearly it's chosen as an oral presentation, it is obvious that the community wants to hear that data.
很明顯,它被選為口頭報告,很明顯社群希望聽到這些數據。
And with regard to Treanda, we of course have now developed a novel liquid formulation and eliminated the lyophilization process in manufacturing.
至於 Treanda,我們現在當然已經開發出一種新型液體製劑,並取消了製造過程中的凍乾過程。
And Lipsy's also providing a unique enhanced safety and profile, cutting down potential for human error.
Lipsy 還提供獨特的增強安全性和配置文件,減少人為錯誤的可能性。
The FDA has accepted IS NDA and there will be a review of the new liquid formulation of Treanda.
FDA 已接受 IS NDA,並將對 Treanda 的新液體製劑進行審查。
This is all part of trying to make better management for patients and Treanda is a great example of that.
這一切都是為了更好地管理患者,而 Treanda 就是一個很好的例子。
Operator
Operator
Ken Cacciatore, Cowen and Co.
Ken Cacciatore, Cowen and Co.
- Analyst
- Analyst
Thanks.
謝謝。
This is Anant for Ken, actually.
實際上,這是 Ken 的 Anant。
Just had a quick clarification question.
剛剛有一個快速澄清的問題。
Eyal, I just wanted to clarify your comments on generic Pulmicort.
Eyal,我只是想澄清一下你對普通 Pulmicort 的評論。
I apologize if you have covered this before.
如果您之前已經介紹過,我深表歉意。
Assuming Apotex and Actavis enter the market, are you reiterating your guidance if they are entering the market?
假設 Apotex 和 Actavis 進入市場,如果他們進入市場,你是否重申你的指導意見?
I'm assuming it is a fairly low-margin product.
我假設這是一種利潤率相當低的產品。
And then I have another question on Copaxone after that.
之後我還有另一個關於 Copaxone 的問題。
- CFO
- CFO
The answer is yes, we are reiterating the guidance on guidance rate.
答案是肯定的,我們重申對指導率的指導。
Even if we see a second competitor.
即使我們看到第二個競爭對手。
Always a generic form, of course, in the market.
當然,在市場上始終是通用形式。
You have to remember that once our arrangement of royalties with AstraZeneca, is that royalty level goes down if there is a second competitor.
你必須記住,一旦我們與阿斯利康安排了特許權使用費,如果有第二個競爭對手,特許權使用費水平就會下降。
So the hit to profit would be reduced by that mechanism.
因此,該機制將減少對利潤的打擊。
- Analyst
- Analyst
Okay thank you.
好的謝謝你。
Now that you've filed the three times weekly, could you talk about your expectations for this product in the long-term?
既然你已經每週提交 3 次,你能談談你對這個產品的長期期望嗎?
Do you think you might be able to transition a majority of the existing Copaxone formulation to the three times weekly?
您認為您是否可以將大部分現有的 Copaxone 配方轉變為每週 3 次?
Thanks.
謝謝。
- President and CEO
- President and CEO
Anant, Why don't we get John to answer that and I'll also ask Michael to comment a little bit about some of the things about Copaxone as well.
Anant,為什麼我們不讓 John 回答這個問題,我也會請 Michael 對有關 Copaxone 的一些事情發表一些評論。
John start us and hand over to Michael please?
約翰開始我們並交給邁克爾好嗎?
- SVP of Global Medicines
- SVP of Global Medicines
Yes, Anant, thanks for the question.
是的,阿南特,謝謝你的提問。
We have stated back in December during the Strategy Day that we are modeling right now about 30% to 35% of the patients currently on the daily Copaxone, we'll find three times a week preference.
我們在 12 月的戰略日期間曾表示,我們現在正在對目前每天服用 Copaxone 的患者中約 30% 至 35% 的患者進行建模,我們會發現每週服用 3 次的偏好。
Some of the market research that we have been doing in preparation of that introduction showed that it could go as high as 50%.
我們在準備該介紹時所做的一些市場調查表明,它可能高達 50%。
But we continue to model right now at about a third that have population are going to find interest in that.
但是我們現在繼續建模,大約有三分之一的人會對它感興趣。
Certainly excited about bringing that forward.
當然很高興提出這一點。
There is a strong interest in it.
對它產生了濃厚的興趣。
But there is also a strong interest in the ones today as well.
但今天也有對這些的濃厚興趣。
Michael, do you want to answer --
邁克爾,你想回答——
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
Thank you, John, and also we are excited about bringing this to patients.
謝謝你,約翰,我們也很高興能把它帶給病人。
Also the recent data that we published in Expert Opinion and Therapeutic Target, showing how the mechanics of action of Copaxone are providing a lot more clarity.
我們最近在專家意見和治療目標上發表的數據也顯示了 Copaxone 的作用機制如何提供更多的清晰度。
We compared that reported with generics and to our surprise, even though this is a generic, the pathways of activation of these generics compared to Copaxone are markedly different with the potential for altered changes with potential changes in inflammatory pathways, so what goes up with Copaxone, goes down and this has significant implications.
我們將報告與仿製藥進行了比較,令我們驚訝的是,儘管這是仿製藥,但與 Copaxone 相比,這些仿製藥的激活途徑明顯不同,炎症通路的潛在變化可能會發生改變,那麼 Copaxone 會發生什麼,下降,這具有重要意義。
So the bottom line for us is that we strongly believe that any generic will need clinical trials to really prove efficacy.
所以我們的底線是,我們堅信任何仿製藥都需要臨床試驗才能真正證明療效。
Very complex molecule, difficult to produce, and I think we are seeing now more and more evidence around that, in terms of the pathways that are activated that appear to be markedly different between Copaxone and purported generics.
非常複雜的分子,難以生產,我認為我們現在看到越來越多的證據表明,在 Copaxone 和所謂的仿製藥之間似乎明顯不同的激活途徑方面。
- Analyst
- Analyst
Thank you.
謝謝你。
Operator
Operator
David Buck, Buckingham Research.
大衛·巴克,白金漢研究中心。
David, you line is open for a question.
大衛,你的熱線可以提問。
If your phone is on mute, please unmute it.
如果您的手機處於靜音狀態,請將其取消靜音。
We'll move on to the next question.
我們將繼續下一個問題。
David Maris, BMO.
大衛·馬里斯,BMO。
- Analyst
- Analyst
Thank you for taking the follow-up.
感謝您的跟進。
Two, first on Treanda, what can you tell us about this formulation, the life cycle formulation and what its value proposition is?
第二,首先是關於 Treanda,關於這個公式、生命週期公式及其價值主張,您能告訴我們什麼?
And secondly, there was a lot of news this past quarter on biosimilar, some from your own partner.
其次,上個季度有很多關於生物仿製藥的新聞,其中一些來自您自己的合作夥伴。
What can you tell us about your current activities and any change or expectations adjustment to what you think the market opportunity is and the timing of the market evolving?
您能告訴我們您當前的活動以及您認為市場機會和市場發展時機的任何變化或預期調整嗎?
- President of Global R&D and Chief Scientific Officer
- President of Global R&D and Chief Scientific Officer
So just to say that we are continuing to look at novel ways to expand the life cycle of Treanda.
所以只是說我們正在繼續尋找新的方法來擴展 Treanda 的生命週期。
Looking at new formulations, including novel ways to deliver this.
尋找新的配方,包括實現這一目標的新方法。
I don't want to get into too much detail on that, but I think the liquid formulations, just one example, but there are numerous others that will be able to extend the life cycle of Treanda in ways that are going to be significant for patients.
我不想在這方面談太多細節,但我認為液體製劑只是一個例子,但還有許多其他製劑能夠延長 Treanda 的生命週期,這對患者。
There are many opportunities to deliver this product in improved formulation as a result that will, are likely to extend the life cycle.
有很多機會以改進的配方交付該產品,因此很可能會延長生命週期。
Jeremy?
傑里米?
- President and CEO
- President and CEO
David, just a brief comment on this.
大衛,我只是對此作了簡短的評論。
I know there has been a lot of news in this area by a number of different organizations, a lot of discussion around the opportunities and otherwise.
我知道許多不同的組織在這個領域發布了很多新聞,圍繞機會和其他方面進行了很多討論。
But the potential to develop and manufacture and market affordable, efficacious and safe biosimilars is, in my opinion and our opinion, an area of significant opportunity.
但在我和我們看來,開發、製造和銷售負擔得起的、有效和安全的生物仿製藥的潛力是一個具有重大機遇的領域。
One has to really shape the opportunity, pick the opportunity and be very clear about what you are doing there.
一個人必須真正塑造機會,挑選機會並非常清楚你在那裡做什麼。
We both Teva and Lonza, both as partners in individual companies as you know, are focusing on finding the best route to realize the benefits that safe biosimilars will bring to the community at large, both in the US, abroad and in the emerging markets.
如您所知,我們梯瓦和龍沙都是各個公司的合作夥伴,他們正專注於尋找最佳途徑,以實現安全的生物仿製藥將給美國、國外和新興市場的整個社區帶來的好處。
As we know in some of these areas there is significant regulatory uncertainty in the biosimilars area and from that perspective, while the partnership continues to explore the field, both companies are taking a very measured approach.
正如我們所知,在其中一些領域,生物仿製藥領域存在很大的監管不確定性,從這個角度來看,雖然合作夥伴繼續探索該領域,但兩家公司都在採取非常謹慎的方法。
Michael is looking at it very hard from the pipeline perspective and choosing really to evaluate fully both the prevailing regulatory and commercial circumstances before taking any decisions in long-term investments.
邁克爾從管道的角度非常認真地看待它,並真正選擇在做出任何長期投資決定之前全面評估現行監管和商業環境。
But it is an area that we both regard and certainly have a regard of, I'll speak to Teva's perspective, as of great potential and we continue to look at it very careful and selectively.
但這是一個我們都關注並且肯定關注的領域,我會從 Teva 的角度來看,因為它具有巨大的潛力,我們將繼續非常仔細和有選擇地研究它。
- Analyst
- Analyst
Thank you.
謝謝你。
Operator
Operator
At this time I will turn the call over to Dr. Jeremy Levin for closing remarks.
此時我將把電話轉給 Jeremy Levin 博士作結束語。
- President and CEO
- President and CEO
Thank you, everybody, for spending the time with us this morning.
謝謝大家今天早上花時間和我們在一起。
I'm sure there will be other calls later on, and we look forward to those discussions.
我相信以後還會有其他電話會議,我們期待著這些討論。
And I greatly appreciate you time.
我非常感謝你的時間。
This is the end of my, I can no longer say I'm new in this job, it's been one year and I really greatly appreciate the opportunity I have had with many of you over the last year to hear your opinion and help shape our thinking as to how we bring value to everybody, specifically our shareholders.
我的工作到此結束,我不能再說我是這份工作的新手了,已經一年了,我真的非常感謝在過去的一年裡有機會與你們中的許多人一起聽取你們的意見並幫助塑造我們的思考我們如何為每個人帶來價值,特別是我們的股東。
Thank you, bye, bye.
謝謝,再見,再見。
Operator
Operator
Thank you, ladies and gentlemen.
謝謝你們,女士們,先生們。
This conference will be available for replay starting today at 10.30 AM Eastern Time until May 9, 2013 until 11.50 PM Eastern Time.
從東部時間今天上午 10 點 30 分開始,到東部時間 2013 年 5 月 9 日晚上 11 點 50 分,可以重播此會議。
The replay phone numbers are 888-849-7419.
重播電話號碼是 888-849-7419。
For international 1-630-652-3042.
國際 1-630-652-3042。
The passcode number is 34657214 followed by the hash key.
密碼數字是 34657214,後跟哈希鍵。
This concludes today's conference.
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。