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Operator
Operator
Good afternoon.
下午好。
Thank you for standing by and welcome to the first quarter 2017 results call.
感謝您的支持,歡迎參加 2017 年第一季度業績電話會議。
(Operator Instructions) I must advise you this conference is being recorded today on Thursday, the 11th of May 2017.
(操作員說明)我必須告訴您,本次會議將於 2017 年 5 月 11 日星期四錄製。
I would now like to hand the conference over to your speaker today, Kevin Mannix, Senior Vice President, Head of Investor Relations.
我現在想把會議交給你今天的演講者,高級副總裁兼投資者關係主管凱文曼尼克斯。
Please go ahead, sir.
請繼續,先生。
Kevin Mannix - Senior Vice President, Head of Investor Relations
Kevin Mannix - Senior Vice President, Head of Investor Relations
Thank you, Vivienne.
謝謝你,薇薇安。
And thank you, everyone, for joining us today to discuss Teva's First Quarter 2017 Financial Results.
感謝大家今天加入我們討論梯瓦公司 2017 年第一季度財務業績。
On the call with us today are: Dr. Sol Barer, Chairman of the Board; Dr. Yitzhak Peterburg, Interim President and CEO; Eyal Desheh, Chief Financial Officer; Dipankar Bhattacharjee, Global Generic Medicines; Dr. Rob Koremans, Global Specialty Medicines; Dr. Michael Hayden, Global R&D, Chief Scientific Officer; Hafrun Fridriksdottir, Global Generics R&D; Dr. Carlo De Notaristefani, Global Operations; and David Stark, Chief Legal Officer.
今天與我們通話的有: 董事會主席 Sol Barer 博士; Yitzhak Peterburg 博士,臨時總裁兼首席執行官; Eyal Desheh,首席財務官; Dipankar Bhattacharjee,全球仿製藥; Rob Koremans 博士,全球特種藥物; Michael Hayden 博士,全球研發,首席科學官; Hafrun Fridriksdottir,全球仿製藥研發;全球運營部 Carlo De Notarisefani 博士;和首席法務官大衛·斯塔克。
We'll start the call with opening remarks from Sol and Dr. Peterburg, followed by a representation from Eyal.
我們將以 Sol 和 Peterburg 博士的開場白開始電話會議,然後是 Eyal 的代表。
We'll then open the call up for questions and answers.
然後,我們將打開電話詢問問題和答案。
A copy of the slides can be found on our website at www.tevapharm.com as well as on our Teva Investor Relations app.
您可以在我們的網站 www.tevapharm.com 以及我們的 Teva 投資者關係應用程序上找到幻燈片的副本。
During this call, we'll be making forward-looking statements, which are predictions, projections or other statements about future events.
在本次電話會議中,我們將做出前瞻性陳述,即對未來事件的預測、預測或其他陳述。
These estimates reflect management's current expectations for Teva's performance.
這些估計反映了管理層目前對梯瓦(Teva)業績的預期。
Actual results may vary, whether as a result of exchange rate differences, market conditions or other factors.
實際結果可能因匯率差異、市場條件或其他因素而有所不同。
In addition, the non-GAAP figures exclude the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step-up, legal settlements and reserves, impairments and related tax effects.
此外,非公認會計原則數據不包括所購無形資產的攤銷、與某些監管行動相關的成本、庫存增加、法律結算和準備金、減值和相關稅收影響。
The non-GAAP data presented by Teva are used by Teva's management and Board of Directors to evaluate the operational performance of the company to compare against the company's work plans and budgets and ultimately to evaluate the performance of management.
Teva 提供的非 GAAP 數據被 Teva 的管理層和董事會用來評估公司的運營績效,以與公司的工作計劃和預算進行比較,並最終評估管理層的績效。
Teva provides such non-GAAP data to investors as a supplement of data and not in substitution or replacement for GAAP results because management believes such data provides useful information to investors.
Teva 向投資者提供此類非 GAAP 數據作為數據的補充,而不是替代或替代 GAAP 結果,因為管理層認為此類數據為投資者提供了有用的信息。
And with that, I'll now turn the call over to our Chairman.
有了這個,我現在將把電話轉給我們的主席。
Sol, if you would please?
索爾,你願意嗎?
Sol J. Barer - Chairman of the Board
Sol J. Barer - Chairman of the Board
Thank you, Kevin, and thank you all for joining us today.
謝謝你,凱文,謝謝大家今天加入我們。
Before we get into the details of our first quarter 2017 results, I want to take a few minutes to discuss the board's ongoing search to identify a permanent CEO.
在我們詳細了解 2017 年第一季度的業績之前,我想花幾分鐘時間討論一下董事會正在進行的尋找常任 CEO 的工作。
As I've indicated previously, this is my highest priority.
正如我之前所指出的,這是我的最高優先級。
We are looking for a world-class individual with deep and broad pharmaceutical experience, an individual with experience dealing with global and complex companies with a strong sense of corporate responsibility and proven strategic and operational capabilities.
我們正在尋找一位具有深厚而廣泛的製藥經驗的世界級人才,一位具有與全球和復雜公司打交道經驗、具有強烈企業責任感和成熟的戰略和運營能力的人才。
The process is moving along very well.
這個過程進展順利。
We have interviewed a number of excellent candidates from all over the world.
我們採訪了來自世界各地的許多優秀候選人。
We are extremely encouraged by the talent and the overall quality of the pharmaceutical executives we are meeting with.
我們會見的製藥業高管的人才和整體素質讓我們深受鼓舞。
The board will continue to take the time it needs to find the best candidate.
董事會將繼續花時間尋找最佳候選人。
But I am pleased with the progress we have made and the speed at which we are moving.
但我對我們取得的進展和我們前進的速度感到滿意。
While the CEO search process continues, the work of Teva to stabilize the business and deliver for shareholders has been significant.
在 CEO 尋找過程繼續進行的同時,梯瓦 (Teva) 穩定業務和為股東提供服務的工作意義重大。
I said it last quarter and I will say it again, as interim CEO, Yitzhak has the full support of the board to drive forward on Teva's strategies and key priorities.
我在上個季度說過,我會再說一遍,作為臨時首席執行官,Yitzhak 得到了董事會的全力支持,以推動 Teva 的戰略和關鍵優先事項。
Execution remains the focus.
執行仍然是重點。
The industry is facing turbulent times and there remain challenges in the business.
該行業正面臨動盪時期,業務仍面臨挑戰。
But I am confident that while the board and I focus on finding the right individual to lead Teva forward, we are taking the actions we need to take today to put the company on the right footing, to continue to succeed in the future.
但我相信,儘管我和董事會專注於尋找合適的人選來領導梯瓦製藥向前發展,但我們正在採取今天需要採取的行動,讓公司站穩腳跟,在未來繼續取得成功。
Teva is doing everything in its power to deliver on its promise to shareholders.
Teva 正在盡其所能兌現對股東的承諾。
With that, let me turn the call over to Yitzhak.
有了這個,讓我把電話轉給伊扎克。
Yitzhak Peterburg - Interim CEO, Interim President and Director
Yitzhak Peterburg - Interim CEO, Interim President and Director
Thank you, Sol.
謝謝你,索爾。
Hello, everyone.
大家好。
Thank you for joining us today.
感謝您今天加入我們。
Since I took over 3 months ago, my focus, together with the management team and with the support of the board has been to execute on our previously discussed priorities for the year, which are extracting synergies related to the Actavis Generics transaction, driving additional efficiencies throughout the organization, supporting cash generation and paying down our debt and delivering on our promises of the specialty pipeline and key generic launches.
自從我在 3 個多月前接手以來,我與管理團隊以及在董事會的支持下,一直專注於執行我們之前討論過的本年度優先事項,即提取與 Actavis Generics 交易相關的協同效應,提高效率在整個組織中,支持現金產生和償還我們的債務,並兌現我們對專業管道和關鍵仿製藥推出的承諾。
First, let me take you through a quick review of our quarterly results.
首先,讓我帶您快速回顧一下我們的季度業績。
Q1 started off 2017 generally as expected and as we guided, which has been the lowest quarter of a back-end loaded year.
2017 年第一季度總體上如預期和我們所指導的那樣開始,這是後端負載一年中最低的一個季度。
Revenues this quarter amounted to $5.6 billion, resulting in a non-GAAP net income of $1.1 billion and a non-GAAP EPS of $1.06.
本季度收入為 56 億美元,非 GAAP 淨收入為 11 億美元,非 GAAP 每股收益為 1.06 美元。
However, cash flow from operations was relatively soft, amounting to $500 million, negatively impacted by multiple one-time payments that were previously disclosed, including a settlement with the U.S. Department of Justice.
然而,運營現金流相對疲軟,為 5 億美元,受到先前披露的多次一次性付款的負面影響,包括與美國司法部的和解。
Compared to Q4 2016, which marks the first full quarter consolidation of Actavis into our overall group results, revenues declined 30% primarily due to impacts resulting from a devaluation of the Venezuelan currency, which totaled $400 million, losses of exclusivity in the specialty segment during Q1 and divestment in the U.K. related to the Actavis Generics acquisition.
與 2016 年第四季度(阿特維斯首次將阿特維斯整合到我們的整體集團業績中)相比,收入下降了 30%,這主要是由於委內瑞拉貨幣貶值造成的影響,總計 4 億美元;與 Actavis Generics 收購有關的第一季度和英國撤資。
We were able to mitigate approximately half of the decrease in the operating profit through a reduction in operating expenses.
通過減少運營費用,我們能夠減輕大約一半的營業利潤下降。
Now let me elaborate on some of the progress and challenges we experienced with our key priorities.
現在讓我詳細說明我們在關鍵優先事項方面所取得的一些進展和挑戰。
As it relates to our first priority, I'm pleased to report the synergies related to the Actavis Generics acquisition and additional cost reduction, which the company has identified, is now on track to realize cumulative net synergies and cost reduction of approximately $1.5 billion by the end of 2017.
由於它關係到我們的首要任務,我很高興地報告與收購 Actavis Generics 相關的協同效應和公司已經確定的額外成本降低,現在有望實現累計淨協同效應和成本降低約 15 億美元2017 年底。
This is compared to our spend base in the full year of 2016 combined company pro forma.
這與我們在 2016 年合併後的公司備考中的全年支出基數進行了比較。
This is almost $200 million more than what we guided to in January and is the result of an extensive review.
這比我們在 1 月份的指導值高出近 2 億美元,是廣泛審查的結果。
Our second priority was to extract additional efficiencies in our organization.
我們的第二個優先事項是在我們的組織中提高效率。
This was achieved during the quarter through various cost-saving measures, including initiation of site closures in R&D, restructuring in our global operation and additional initiatives, primarily consisting of headcount reduction and expense cuts.
這是在本季度通過各種節省成本的措施實現的,包括啟動研發基地關閉、重組我們的全球運營和其他舉措,主要包括裁員和削減開支。
In most instances, we have witnessed an acceleration of planned cost savings.
在大多數情況下,我們見證了計劃成本節約的加速。
Since the close of the Actavis Generics transaction, we have reduced our headcount by approximately 5,000 people and expect further reductions through the end of 2017.
自阿特維斯仿製藥交易完成以來,我們已將員工人數減少了約 5,000 人,預計到 2017 年底將進一步裁員。
Moving to our third priority of supporting cash generation and paying down $5 billion of debt in 2017, we are pleased that we reduced our gross debt by $1.2 billion from $35.8 billion at year-end 2016 to $34.6 billion at the end of the first quarter.
在 2017 年支持現金產生和償還 50 億美元債務這一第三優先事項上,我們很高興將總債務從 2016 年底的 358 億美元減少到第一季度末的 346 億美元,減少了 12 億美元。
As discussed at a high level in January, part of the funds that we assume will help pay down the $5 billion are expected to come from divestiture proceeds.
正如 1 月份在高層討論的那樣,我們認為將有助於償還 50 億美元的部分資金預計將來自剝離收益。
Since taking over in February, I've worked extensively with the board and management team to identify the relevant non-core assets to be divested.
自 2 月接任以來,我與董事會和管理團隊進行了廣泛合作,以確定要剝離的相關非核心資產。
Teva has elected to pursue the sale of its global Women's Health business.
Teva 已選擇出售其全球女性健康業務。
And we have engaged Morgan Stanley to serve as our financial adviser.
我們已聘請摩根士丹利擔任我們的財務顧問。
In addition, we have elected to sell our Oncology and Pain business in Europe, where Bank of America will serve as our financial adviser.
此外,我們已選擇在歐洲出售我們的腫瘤和疼痛業務,美國銀行將擔任我們的財務顧問。
We expect the sale process for both businesses to commence in the coming weeks with the distribution of marketing materials to interested buyers.
我們預計兩家企業的銷售流程將在未來幾週內開始,向感興趣的買家分發營銷材料。
We believe we will be able to complete this transaction by the end of the year, subject to evaluation of pricing proposals and board approvals.
我們相信,在評估定價建議和董事會批准後,我們將能夠在今年年底前完成這項交易。
We believe that the proceeds from the sale of both businesses as well as additional asset sales will be significantly in excess of our previously identified target of $1 billion.
我們認為,出售這兩項業務以及額外資產出售的收益將大大超過我們先前確定的 10 億美元的目標。
Our fourth priority, delivering on the promise of the specialty pipeline and key generic launches: During the quarter, we received 8 approvals in our specialty business including AirDuo RespiClick and ArmonAir RespiClick in the U.S., and 5 in our growth markets.
我們的第四個優先事項,兌現專業管道和關鍵仿製藥發布的承諾:在本季度,我們的專業業務獲得了 8 項批准,包括美國的 AirDuo RespiClick 和 ArmonAir RespiClick,以及我們的增長市場中的 5 項。
Furthermore, AUSTEDO or SD-809 for Huntington's disease was approved in the U.S. on April 3 and was launched less than 2 weeks later with revenues expected beginning in July.
此外,用於亨廷頓病的 AUSTEDO 或 SD-809於 4 月 3 日在美國獲得批准,並在不到 2 週後推出,預計將於 7 月開始收入。
It is still very early in the launch, but the initial data we have from a small dataset is encouraging.
它還處於發布的早期階段,但我們從一個小數據集中獲得的初始數據令人鼓舞。
AUSTEDO for tardive dyskinesia was granted priority review by the FDA and provided a PDUFA date of August 30.
用於遲發性運動障礙的 AUSTEDO 獲得了 FDA 的優先審查,並提供了 8 月 30 日的 PDUFA 日期。
Assuming we are successful in obtaining final approval, that would put us in a position for a launch in September.
假設我們成功獲得最終批准,這將使我們能夠在 9 月推出。
We are also quickly approaching a very important readout for our anti-CGRP Fremanezumab with pivotal Phase III results for both chronic and episodic migraine expected next month.
我們也正在迅速接近我們的抗 CGRP Fremanezumab 的一個非常重要的讀數,預計下個月慢性和發作性偏頭痛的關鍵 III 期結果。
As we all know, there are always risks when it comes R&D.
眾所周知,研發總是有風險的。
And we were reminded of that just a week ago when we announced that the CONCERTO trial of Laquinimod in relapsing-remitting multiple sclerosis did not meet its primary endpoint.
就在一周前,當我們宣布 Laquinimod 在復發緩解型多發性硬化症中的 CONCERTO 試驗未達到其主要終點時,我們想起了這一點。
While we are disappointed for MS patients around the world, we have no further plans to pursue Laquinimod in relapsing-remitting multiple sclerosis.
雖然我們對世界各地的多發性硬化症患者感到失望,但我們沒有進一步計劃在復發緩解型多發性硬化症中尋求拉喹莫德。
Turning to generics.
轉向泛型。
It has been 2 full quarters since the completion of our acquisition of Actavis Generics.
自我們完成對 Actavis Generics 的收購以來,已經過去了 2 個完整的季度。
The acquisition has provided us with many benefits, especially much stronger and broader R&D capabilities, which we believe are the engine for any substantial generic business.
此次收購為我們帶來了許多好處,尤其是更強大和更廣泛的研發能力,我們認為這是任何實質性仿製藥業務的引擎。
This is essential in today's world when we are operating across such an evolving competitive landscape and ongoing consolidation across our customer base.
當我們在如此不斷變化的競爭環境中運營並在我們的客戶群中持續整合時,這在當今世界中至關重要。
We are very confident that the global business we have built will allow Teva to thrive in the long-term future as a leader in the generics industry.
我們非常有信心,我們建立的全球業務將使 Teva 作為仿製藥行業的領導者在長期未來蓬勃發展。
Our generic business is not immune to the challenges other companies in our industry are currently facing with increased competition and consolidation.
我們的仿製藥業務不能倖免於我們行業中其他公司目前面臨的競爭和整合加劇的挑戰。
This is reflected in the most recent analysis we completed that looks at net price erosion in our U.S.-based business, which came in at 7% versus the approximately 5% that we communicated previously.
這反映在我們最近完成的分析中,該分析著眼於我們美國業務的淨價格侵蝕,這一比例為 7%,而我們之前傳達的約為 5%。
The 2 biggest contributing factors to this change are the ongoing consolidation of our key customers and the increase in generic drug approval by the FDA, which has created additional competition.
促成這一變化的兩個最大因素是我們主要客戶的持續整合以及 FDA 對仿製藥的批准增加,這帶來了額外的競爭。
The situation in Venezuela continues to deteriorate, which has led to greater instability that could negatively impact our business in the country, including our ability to produce more drugs.
委內瑞拉的局勢繼續惡化,導致更大的不穩定,可能對我們在該國的業務產生負面影響,包括我們生產更多藥物的能力。
This could have an impact on our projections, which include approximately $0.11 of earnings generated by Venezuela over the last 3 quarters of 2017.
這可能會對我們的預測產生影響,其中包括委內瑞拉在 2017 年最後三個季度產生的大約 0.11 美元的收入。
In 2016, we adjusted the exchange rate twice.
2016年,我們兩次調整匯率。
And in February 2017, we further updated the exchange rate to its current rate of VEF 380 per $1.
並且在 2017 年 2 月,我們將匯率進一步更新為當前的每 1 美元 380 維法郎的匯率。
Just to put it in perspective, in Q1 2017, revenues of generic and OTC medicine in Venezuela amounted to $21 million compared to $238 million in Q1 2016 and more than $435 million in Q4 2016.
客觀地說,2017 年第一季度,委內瑞拉的仿製藥和非處方藥收入為 2100 萬美元,而 2016 年第一季度為 2.38 億美元,2016 年第四季度則超過 4.35 億美元。
As we stated in our press release from this morning, we are reaffirming our 2017 outlook.
正如我們在今天上午的新聞稿中所述,我們重申了 2017 年的展望。
We are committing to being transparent.
我們致力於保持透明。
And therefore, we wanted to provide more clarity into our business and the moving parts of our projections, specifically regarding the challenges in the U.S. generic market and Venezuela.
因此,我們希望更清楚地了解我們的業務和我們預測的動態部分,特別是關於美國仿製藥市場和委內瑞拉的挑戰。
We will continue to keep you informed throughout the year as our team works extremely hard to execute on all of our promises and priorities for 2017.
隨著我們的團隊非常努力地履行我們對 2017 年的所有承諾和優先事項,我們將在全年繼續為您提供最新信息。
Finally, I would like to take this opportunity to say a few words about the Eyal Desheh, our CFO, whose planned departure we announced a few weeks ago.
最後,我想藉此機會談談我們的首席財務官 Eyal Desheh,我們幾週前宣布了他的離職計劃。
Eyal has contributed significantly to Teva's growth and success throughout his tenure.
在整個任期內,Eyal 為 Teva 的成長和成功做出了重大貢獻。
I'm pleased to announce that Michael McClellan will serve as an interim CFO effective July 1. Prior to joining Teva, Mike was the U.S. CFO at Sanofi, where his career spanned over 20 years in roles of increasing responsibility in global finance and health care.
我很高興地宣布,Michael McClellan 將於 7 月 1 日起擔任臨時首席財務官。在加入 Teva 之前,Mike 是賽諾菲 (Sanofi) 的美國首席財務官,他的職業生涯跨越 20 多年,在全球金融和醫療保健領域擔任越來越多的職責.
For the last 2 years, Mike has served as a CFO of our Global Specialty Medicines division.
在過去的 2 年裡,Mike 一直擔任我們全球特種藥物部門的首席財務官。
I'm confident he will be an excellent addition to our team.
我相信他會成為我們球隊的一個很好的補充。
Eyal and Mike will work closely together to ensure a smooth transition.
Eyal 和 Mike 將密切合作以確保順利過渡。
As we have stated previously, we expect our new CEO to have a significant role in identifying a permanent successor.
正如我們之前所說,我們希望我們的新 CEO 在確定永久繼任者方面發揮重要作用。
Thank you.
謝謝你。
And I now turn the call over to Eyal to provide more insight into the numbers.
我現在將電話轉給 Eyal,以提供對這些數字的更多見解。
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
Thank you very much, Yitzhak.
非常感謝,伊扎克。
Good morning, and good afternoon, everyone.
大家早上好,下午好。
Before I dive into the Q1 numbers, let me say a few personal words.
在我深入研究第一季度的數字之前,讓我說幾句個人話。
As you read in our press release this morning and heard from Yitzhak just now, I will retire from my CFO role in Teva on June 30 this year.
正如您今天上午在我們的新聞稿中看到的那樣,以及剛剛從 Yitzhak 那裡聽到的消息,我將於今年 6 月 30 日從梯瓦 (Teva) 的首席財務官職位上退休。
So this is the last quarter I report as the CFO of this amazing company.
所以這是我作為這家了不起的公司的首席財務官報告的最後一個季度。
I shared my views with you -- with all of you for 37 quarters in a row.
我連續 37 個季度與你們分享了我的觀點。
And I hope that I have served you well, enabling all of you to better understand Teva and its developing business model.
我希望我能很好地為大家服務,讓大家更好地了解 Teva 及其發展中的商業模式。
I worked with Teva for over 16 years in 2 periods.
我在 Teva 工作了超過 16 年,分兩個時期。
I worked with outstanding people.
我與優秀的人一起工作。
And together, we faced challenges and successes.
我們一起面臨挑戰和成功。
I'm ready and looking forward to the next chapter in my professional career, which will commence soon.
我已經準備好並期待著我職業生涯的下一章即將開始。
And there is no question that I will miss Teva, the excitement, and I will miss the interaction with all of you.
毫無疑問,我會想念 Teva,那種興奮,我會想念與你們所有人的互動。
I'm sure that I will cross paths with many of you going forward.
我相信我會與你們中的許多人一起前進。
With Mike taking over as Interim CFO, I am convinced that Teva finance is in very good hands.
隨著 Mike 接任臨時首席財務官,我確信 Teva 財務狀況良好。
Mike is an experienced finance executive and will be a great leader to the excellent finance team we have in Teva and will do that during his transition period.
Mike 是一位經驗豐富的財務主管,他將成為我們在梯瓦 (Teva) 擁有的優秀財務團隊的優秀領導者,並將在他的過渡期間做到這一點。
So good luck to you, Mike.
祝你好運,邁克。
Now let's take a few minutes to review the results of the first quarter of 2017.
現在讓我們花幾分鐘時間回顧一下 2017 年第一季度的業績。
As always, I will take you through both GAAP and non-GAAP results.
與往常一樣,我將帶您了解 GAAP 和非 GAAP 結果。
Our highlights for the quarter include revenues of $5.6 billion and earnings per share of $1.06 on a non-GAAP basis and $0.57 on a full GAAP basis.
我們本季度的亮點包括 56 億美元的收入和 1.06 美元的非 GAAP 每股收益和 0.57 美元的完整 GAAP 基礎。
Our GAAP results were impacted by several items in the quarter.
我們的公認會計原則結果受到本季度幾個項目的影響。
And I'll take you through the list of exclusions in a few slides.
我將在幾張幻燈片中向您介紹排除列表。
Compared to the first quarter of 2016 we were up on operating revenues, operating income and EBITDA as a result of the inorganic moves we made, including both the Actavis Generics acquisition and the joint venture with Takeda in Japan.
與 2016 年第一季度相比,我們的營業收入、營業收入和 EBITDA 均有所增長,這得益於我們採取的一些無形舉措,包括收購阿特維斯仿製藥以及與日本武田 (Takeda) 的合資企業。
As this is our second quarter, full quarter with Actavis, I will also take you through a comparison with Q4 2016 in a few slides.
由於這是我們的第二季度,即阿特維斯的整個季度,我還將通過幾張幻燈片向您介紹與 2016 年第四季度的比較。
Our cash flow from operations this quarter was unusually low as we had a number of large irregular items.
我們本季度的運營現金流異常低,因為我們有許多大型不規則項目。
And I will share the details shortly.
我將很快分享細節。
We did receive approximately $700 million in January for the divestment of portions of the Actavis business in the U.K. and Ireland.
1 月份,我們確實收到了大約 7 億美元,用於剝離阿特維斯在英國和愛爾蘭的部分業務。
But this is not part of our cash flow from operations.
但這不是我們運營現金流的一部分。
However, we'll use it to pay down debt.
但是,我們將用它來償還債務。
Non-GAAP adjustments for the quarter amounted to $0.5 billion.
本季度的非公認會計原則調整為 5 億美元。
The largest line item is amortization reflecting the run rate of the combined company.
最大的項目是反映合併後公司運行率的攤銷。
We had relatively high restructuring expenses, which are related to the efficiency measures we are taking throughout the company both related to our integration with Actavis and to the additional measures being taken.
我們的重組費用相對較高,這與我們在整個公司採取的效率措施有關,既與我們與阿特維斯的整合有關,也與正在採取的額外措施有關。
We also excluded $52 million, which are related to the decrease in the British pound, which affected the value of the assets sold in the U.K. and Ireland, which were already divested.
我們還排除了 5200 萬美元,這與英鎊貶值有關,這影響了在英國和愛爾蘭出售的資產的價值,這些資產已經被剝離。
We adjusted the exchange rate I used for Venezuela bolivar twice during 2016 as you already heard from Yitzhak, and once again, in February 2017 to VEF 380 per $1.
正如您從 Yitzhak 那裡聽到的那樣,我們在 2016 年兩次調整了我用於委內瑞拉玻利瓦爾的匯率,並在 2017 年 2 月再次調整為每 1 美元 380 VEF。
This is a blended rate.
這是一個混合匯率。
This has a negative impact of $217 million in revenues and $67 million in operating income as compared to Q1 in 2016.
與 2016 年第一季度相比,這產生了 2.17 億美元的收入和 6700 萬美元的營業收入的負面影響。
So there was no contribution for Venezuela to our earnings per share this quarter, 0. In light of the economic condition in Venezuela, we excluded the quarterly changes in revenues and operating profit in any discussion of currency effect as you can see in the table.
因此,委內瑞拉對本季度的每股收益沒有貢獻,為 0。鑑於委內瑞拉的經濟狀況,我們在任何關於貨幣效應的討論中排除了收入和營業利潤的季度變化,如您在表中看到的。
Other than the bolivar, foreign exchange impact on our results in the quarter was relatively minor.
除玻利瓦爾外,外匯對我們本季度業績的影響相對較小。
As to EBITDA, Q1 EBITDA was $1.8 billion and EBITDA for the last 4 quarters totaled $7.5 billion.
至於 EBITDA,第一季度 EBITDA 為 18 億美元,過去四個季度的 EBITDA 總計 75 億美元。
Cash flow, cash flow from operations in the quarter was $0.5 billion compared to $1.4 billion in the first quarter of 2016, reflecting several unusual payments made during the quarter.
現金流,本季度的運營現金流為 5 億美元,而 2016 年第一季度為 14 億美元,這反映了本季度發生的幾筆不尋常的付款。
These were FCPA settlements with the SEC and DOJ for more than $0.5 billion, 111 -- $110 million related to a ciprofloxacin settlement and $250 million for the final settlement of our forward starting interest rate swap and treasury lock agreements that matured during the first half of 2017 which was settled and paid in first quarter of 2016 -- of 2017.
這些是 FCPA 與 SEC 和 DOJ 達成的超過 5 億美元的和解,111 - 1.1 億美元與環丙沙星和解有關,以及 2.5 億美元用於我們在上半年到期的遠期起始利率掉期和國庫鎖定協議的最終結算2017 年,於 2016 年第一季度——2017 年第一季度結算並支付。
Proceeds from divestiture related to Actavis Generics of $700 million or a bit more in Q1 '17 are not included in this chart.
17 年第一季度與 Actavis Generics 相關的資產剝離收益為 7 億美元或更多,不包括在此圖表中。
Looking at the rest of the year.
看看今年剩下的時間。
Just as our revenues and earnings are back-end loaded, we expect the same pattern for our cash flow from operations.
正如我們的收入和收益是後端加載一樣,我們預計我們的運營現金流也有相同的模式。
We also are planning on a significant recovery in the second half of the year from Allergan as a true-up to our working capital.
我們還計劃在今年下半年從艾爾建(Allergan)顯著復甦,作為對我們營運資金的補充。
Cash management remains a top priority for the company and the finance team.
現金管理仍然是公司和財務團隊的首要任務。
Liquidity.
流動性。
At the end of Q1 2017, we had total debt, excluding minority shares, of $34.6 billion and debt to EBITDA stood at 4.63x and the net debt to EBITDA, which is used for complying with the bank debt covenant, stood at 4.49, way below the threshold required.
截至 2017 年第一季度末,我們的總債務(不包括少數股權)為 346 億美元,對 EBITDA 的債務為 4.63 倍,對用於遵守銀行債務契約的 EBITDA 的淨債務為 4.49,方式低於要求的閾值。
Compared to the first quarter of 2016, you can see the growth of our generic business both in the U.S. and globally.
與 2016 年第一季度相比,您可以看到我們的仿製藥業務在美國和全球的增長。
COPAXONE revenues declined slightly and our other specialty products declined mostly as a result of the loss of exclusivity for NUVIGIL and AZILECT.
COPAXONE 收入略有下降,我們的其他特種產品下降主要是由於 NUVIGIL 和 AZILECT 的排他性喪失。
However, these declines were offset by a payment of $75 million related to the NINLARO deal, which is included in this quarter.
然而,這些下降被本季度包含的與 NINLARO 交易相關的 7500 萬美元支付所抵消。
You can also see the impact of the Venezuela devaluation, which reduced revenue by over $200 million year-over-year.
您還可以看到委內瑞拉貶值的影響,這導致收入同比減少超過 2 億美元。
Looking at where we made our sales.
看看我們在哪裡進行銷售。
U.S. continues to be the largest market with 56% of revenues.
美國仍然是最大的市場,佔收入的 56%。
European revenues accounted for 27% of total.
歐洲收入佔總收入的 27%。
And our Rest of the World markets are 17%, down from 19% of total last year.
我們在世界其他地區的市場份額為 17%,低於去年的 19%。
Following the inorganic moves of the past year, generics now accounts for 54% of total revenues with COPAXONE down to 17%.
在過去一年的無機變動之後,仿製藥現在佔總收入的 54%,而 COPAXONE 下降到 17%。
Other revenues are up significantly following the acquisition of Anda, which contributed almost $300 million for the quarter to our top line.
收購 Anda 後其他收入顯著增長,該季度為我們的收入貢獻了近 3 億美元。
The increase in our operating profit was driven mainly by our generic business, following the closing of the Actavis transaction.
在阿特維斯交易完成後,我們的營業利潤增長主要是由我們的仿製藥業務推動的。
Our specialty business contributed less following the loss of exclusivity of NUVIGIL and AZILECT as well as the lower profit coming from COPAXONE this quarter.
由於 NUVIGIL 和 AZILECT 的排他性喪失以及本季度 COPAXONE 的利潤下降,我們的專業業務貢獻減少。
All the moving parts resulted in a similar level of profit, though from somewhat different sources.
儘管來源有所不同,但所有活動部件都產生了相似的利潤水平。
Generics is now 42% of our operating profit without G&A while COPAXONE is down to 40% of total.
沒有 G&A 的情況下,仿製藥現在占我們營業利潤的 42%,而 COPAXONE 下降到總利潤的 40%。
The profitability of generic business was very stable -- of our U.S. generic business was very stable this quarter.
仿製藥業務的盈利能力非常穩定——本季度我們的美國仿製藥業務非常穩定。
But there were some movements in other parts of the business.
但該業務的其他部分也出現了一些變化。
The lower gross profit compared to Q4 is driven by the devaluation in Venezuela, which reduced revenues by about $400 million from Q4.
與第四季度相比,毛利潤較低的原因是委內瑞拉貨幣貶值,這使第四季度的收入減少了約 4 億美元。
In addition, compared to Q4, operating profit was impacted by the divestment of certain of the U.K. and Ireland assets that were included in Q4 and with very nice profitability.
此外,與第 4 季度相比,營業利潤受到第 4 季度包含的某些英國和愛爾蘭資產的撤資的影響,這些資產的盈利能力非常好。
And this was divested, as mentioned, in January this year, and in addition, by somewhat lower revenues in Japan.
如前所述,這在今年 1 月被剝離,此外,日本的收入有所下降。
COPAXONE.
科帕松。
COPAXONE performance is in line with ex-U.
COPAXONE 性能與 ex-U 一致。
S. sales maintaining a level of approximately $190 million.
S. 銷售額維持在約 1.9 億美元的水平。
This reflects the penetration of COPAXONE 40 milligram globally and now also outside of U.S., which is over 70% of the units in Europe.
這反映了 COPAXONE 40 毫克在全球的滲透率,現在也在美國以外,佔歐洲單位的 70% 以上。
In the U.S., the quarter was relatively soft from lower volume of COPAXONE 20, partially offset by a price increase of 7.9% in January '17 for both 20- and 40-milligram versions.
在美國,由於 COPAXONE 20 的銷量下降,該季度相對疲軟,部分被 17 年 1 月 20 和 40 毫克版本的價格上漲 7.9% 所抵消。
Now I'd like to take you through 2 additional slides, bridging Q4 2016 and Q1.
現在我想帶你看另外兩張幻燈片,它們連接了 2016 年第四季度和第一季度。
This is the first time we can look at 2 quarters, 2 sequential quarters of the new Teva, which are comparable.
這是我們第一次可以看到具有可比性的新梯瓦的 2 個季度、2 個連續季度。
On revenues, you can see that U.S. generic business was stable compared to Q4, a bit higher, while ex U.S. we saw lower generic revenues in Japan and in Europe following the divestiture of the U.K. and Irish business in January.
在收入方面,您可以看到美國仿製藥業務與第四季度相比保持穩定,略高,而在美國除外,我們看到日本和歐洲的仿製藥收入在 1 月份剝離英國和愛爾蘭業務後有所下降。
In Specialty, we saw lower revenues of COPAXONE as well as the impact of loss of exclusivity of AZILECT and NUVIGIL also compared to Q4.
在專業領域,與第四季度相比,我們看到 COPAXONE 的收入下降,以及失去 AZILECT 和 NUVIGIL 的排他性的影響。
We also had lower payment received in connection with NINLARO, which were $75 million this quarter and $150 million in Q4.
我們收到的與 NINLARO 相關的付款也較低,本季度為 7500 萬美元,第四季度為 1.5 億美元。
Obviously, the biggest piece is Venezuela devaluation, which reduced revenues compared to Q4 by $400 million.
顯然,最大的一塊是委內瑞拉的貶值,與第四季度相比,這使收入減少了 4 億美元。
Our operating income from Q4 to Q1 declined by 17%.
我們從第四季度到第一季度的營業收入下降了 17%。
While gross profit margin of our U.S. generic business remained stable, overall gross profit and gross margin was impacted by the Venezuela devaluation, our business in Japan and the divestment in the U.K. Lower NINLARO income was also a contributor to lower profit and profitability.
雖然我們美國仿製藥業務的毛利率保持穩定,但整體毛利潤和毛利率受到委內瑞拉貶值、日本業務和英國撤資的影響。NINLARO 收入下降也是利潤和盈利能力下降的一個原因。
On the other hand, you could see our efficiency initiatives, which reduced our operating expenses across the board and mitigated some of the decline in the gross profit.
另一方面,您可以看到我們的效率舉措,它全面降低了我們的運營費用,並緩解了毛利潤的部分下降。
And we expect this trend to continue throughout the year.
我們預計這一趨勢將在全年持續。
On our balance sheet compared to December 31, 2016, our balance sheet amounted to total assets of $91.3 billion and total equity of $34 billion.
在我們的資產負債表上,與 2016 年 12 月 31 日相比,我們的資產負債表總資產為 913 億美元,總股本為 340 億美元。
Let me discuss the share count as we have made a change.
讓我討論一下我們進行了更改時的份額數。
It doesn't have an impact.
它沒有影響。
It's fully offset this quarter, but I want to clarify that.
本季度已完全抵消,但我想澄清一下。
The number of shares this quarter on both GAAP and non-GAAP is 1,017,000,000 shares.
本季度 GAAP 和非 GAAP 的股票數量為 1,017,000,000 股。
And it's non-GAAP and GAAP, which is exactly the same.
它是非公認會計原則和公認會計原則,完全一樣。
This number is equal to the 1,076,000,000 shares, so let me explain how.
這個數字等於 1,076,000,000 股,所以讓我解釋一下。
As of December 31, 2016, the number of shares on a non-GAAP basis was 1,076,000,000.
截至 2016 年 12 月 31 日,按非公認會計原則計算的股份數量為 1,076,000,000 股。
This has not changed.
這沒有改變。
However, this quarter, the effect of the MCPS, which is the mandatory convertible shares, was anti-dilutive.
然而,本季度,強制性可轉換股份的 MCPS 的作用是反稀釋的。
So we did not add back $66 million of special dividend to MCPS holders.
因此,我們沒有向 MCPS 持有者返還 6600 萬美元的特別股息。
We didn't add it back to the net income attributable to ordinary shareholders nor did we increase the number of shares by 59.4 million shares.
我們沒有將其加回歸屬於普通股股東的淨利潤,也沒有增加5940萬股。
This has no impact on our earnings per share, which would have remained $1.06 in either treatment as these 2 entries offset each other.
這對我們的每股收益沒有影響,因為這兩個條目相互抵消,因此在任何一種處理中都將保持 1.06 美元。
And last, dividends.
最後,股息。
Our board approved dividend of $0.34 per share for the first quarter of 2017.
我們的董事會批准了 2017 年第一季度每股 0.34 美元的股息。
As a reminder, Teva's board approves dividend payments every quarter after considering the financial condition of the company.
提醒一下,梯瓦的董事會在考慮公司的財務狀況後,每季度批准一次股息支付。
Thank you all for listening to us this morning.
謝謝大家今天早上聽我們講話。
And I would now like to open the call for questions.
我現在想開始提問。
Operator
Operator
(Operator Instructions) We have a question from the line of Gregg Gilbert.
(操作員說明)我們有一個來自 Gregg Gilbert 的問題。
Gregory B. Gilbert - MD and Senior Analyst
Gregory B. Gilbert - MD and Senior Analyst
I'll ask one multipart question upfront.
我會提前問一個多部分的問題。
First, for Sol, what have you learned so far from the CEO search in what candidates see as pros and cons?
首先,對於 Sol,到目前為止,您從 CEO 搜索中學到了哪些候選人認為的利弊?
Second, are the Women's Health and European Oncology, Pain businesses the only businesses for which you're exploring options?
其次,女性健康和歐洲腫瘤學、疼痛業務是您正在探索選擇的唯一業務嗎?
And last, generics in the U.S., are you still as confident as you were before in the flow and size of new product sales from launches in 2017?
最後,對於美國的仿製藥,您對 2017 年推出的新產品銷售的流量和規模是否仍然像以前一樣自信?
And can you provide any specific color on some of those key launches?
你能在其中一些關鍵發布上提供任何特定的顏色嗎?
Sol J. Barer - Chairman of the Board
Sol J. Barer - Chairman of the Board
So this is Sol Barer.
所以這是索爾巴勒。
I'll take the first question in terms of the CEO search.
我將回答關於 CEO 搜索的第一個問題。
I have to say that we are looking, as everyone knows, for the best person to lead Teva.
我不得不說,眾所周知,我們正在尋找領導梯瓦的最佳人選。
And we're looking around the world for this individual who has strong pharmaceutical experience, is a leader, understands the complex situations, has a great deal of integrity, corporate responsibility, et cetera.
我們正在世界各地尋找具有豐富製藥經驗、領導者、了解複雜情況、正直誠信、有企業責任感等的人。
And the one thing that I'm surprised about, to be very honest about it, is the quality of people that we are talking with.
說實話,讓我感到驚訝的一件事是我們正在與之交談的人的素質。
The senior leaders, the ones with experience, I'm very happy with.
高層領導,有經驗的,我很滿意。
So again, this takes some time.
再說一次,這需要一些時間。
But I am very encouraged in terms of who we are talking to.
但就我們正在與誰交談而言,我感到非常鼓舞。
Yitzhak Peterburg - Interim CEO, Interim President and Director
Yitzhak Peterburg - Interim CEO, Interim President and Director
So regarding -- . So regarding your second question.
所以關於——。所以關於你的第二個問題。
Those are the main, exactly as we said, including some other assets.
正如我們所說,這些是主要的,包括其他一些資產。
Some of them are really financial assets and real estate assets and very small other assets.
其中一些實際上是金融資產和房地產資產以及非常小的其他資產。
I don't think we need to go through it.
我認為我們不需要經歷它。
The main 2 assets were identified really undergoing, as we speak.
正如我們所說,主要的 2 項資產確實在進行中。
And as I said, we hope to finalize it during this year.
正如我所說,我們希望在今年完成。
On the third question about generics, I'll ask Dipankar if he can comment.
關於仿製藥的第三個問題,我會問 Dipankar 是否可以發表評論。
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Regarding the U.S. new product launches, as we described before, we are targeting more than 80 different product opportunities that are expected to yield between 40 and 50 launches this year.
關於美國的新產品發布,如前所述,我們瞄準了 80 多種不同的產品機會,預計今年將推出 40 到 50 次。
When we look at the breakdown of all these opportunities, the products where we have a high level of confidence in our ability to launch them this year due to a clear position from legal, regulatory and operational readiness, these are expected to generate approximately $500 million.
當我們查看所有這些機會的細分時,由於法律、監管和運營準備情況明確,我們對今年推出它們的能力充滿信心的產品預計將產生約 5 億美元.
Our ability to generate additional sales beyond the $500 million is the degree of success we achieve from the basket where there is a higher level of risk related to legal, regulatory and operational readiness as well as the competitive environment.
我們創造超過 5 億美元的額外銷售額的能力是我們從籃子中取得的成功程度,在該籃子中,與法律、監管和運營準備以及競爭環境相關的風險水平更高。
It is the breadth and the depth of our generics pipeline that provides us with these numerous opportunities or as we have said in the past, more shots at goal every year.
正是我們的仿製藥管道的廣度和深度為我們提供瞭如此多的機會,或者正如我們過去所說,每年都有更多的射門機會。
As regarding the timing of launches, as you know, most of our 2017 launches are in the second half of the year.
關於發佈時間,大家知道,我們2017年的發布大部分是在下半年。
Operator
Operator
Your next question comes from the line of Jami Rubin.
您的下一個問題來自 Jami Rubin。
Jami Rubin - Equity Analyst
Jami Rubin - Equity Analyst
Just a couple.
只是一對。
Sol, just back to the CEO search, I think I asked this question before, I don't know that I got an answer.
索爾,剛剛回到CEO搜索,我想我之前問過這個問題,我不知道我得到了答案。
But would you be willing to waive the requirement for a CEO to live in Israel?
但你願意放棄 CEO 在以色列居住的要求嗎?
And the second question is you said that $1 billion of the $5 billion of debt repayment this year would come from divestitures.
第二個問題是你說今年 50 億美元的債務償還中有 10 億美元將來自資產剝離。
Would incremental asset sales proceeds beyond the $1 billion accelerate debt repayment?
超過 10 億美元的增量資產出售收益會加速債務償還嗎?
Or will there be other uses of proceeds?
或者收益會有其他用途嗎?
And just my final question, Eyal, to you, just didn't completely understand the explanation of the drivers of gross margin deterioration this quarter.
我的最後一個問題,Eyal,對你來說,只是沒有完全理解本季度毛利率惡化的驅動因素的解釋。
Can you explain that again?
你能再解釋一下嗎?
Sol J. Barer - Chairman of the Board
Sol J. Barer - Chairman of the Board
Okay, so this is Sol Barer.
好的,這就是 Sol Barer。
I'll answer the first question with respect to the CEO.
我將回答關於 CEO 的第一個問題。
As I indicated, Jami, we are looking around the world for the absolute best candidate for Teva.
正如我所指出的,Jami,我們正在世界各地尋找 Teva 的絕對最佳人選。
We are committed once we find that candidate to bring that candidate to Teva.
一旦我們找到該候選人,我們就承諾將該候選人帶到梯瓦。
And we will do what it takes to make that happen, okay, to be very clear about that.
我們將盡一切努力實現這一目標,好吧,非常清楚這一點。
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
Okay.
好的。
So first of all, regarding the asset acceleration, yes, we would like to pay down debt faster and delever the balance sheet.
所以首先,關於資產加速,是的,我們希望更快地償還債務並去槓桿化資產負債表。
Regarding the drivers of our gross margin, compared to Q1 last year, this is a different company.
關於我們毛利率的驅動因素,與去年第一季度相比,這是一家不同的公司。
We have the Anda business, which comes -- it's a distribution business naturally with a much lower margin than our other businesses, both the Generic and the Specialty.
我們有 Anda 業務,它是一個分銷業務,其利潤率自然低於我們的其他業務,包括通用和專業。
And we have divested the U.K. piece.
我們已經剝離了英國的部分。
That has a small impact, but it came with very nice profitability.
這影響很小,但它帶來了非常好的盈利能力。
And of course, we've talked a lot about the impact of Venezuela, which basically the profit completely disappeared and there's 0 profit on $21 million of sales in the results of Q1.
當然,我們已經談了很多關於委內瑞拉的影響,基本上利潤完全消失了,第一季度的銷售額為 2100 萬美元,利潤為 0。
So the impact of all these drivers has reduced the gross margin to where we are today.
因此,所有這些驅動因素的影響將毛利率降低到了今天的水平。
It could improve a little bit later on this year with new launches of generic products.
隨著仿製藥的新推出,它可能會在今年晚些時候有所改善。
But this is the area that could be a bit better.
但這是一個可能會更好的領域。
Jami Rubin - Equity Analyst
Jami Rubin - Equity Analyst
Can you just -- kind of a quick follow-up.
你能不能 - 一種快速的跟進。
We thought you had said about $900 million of new product sales this year.
我們以為你說今年的新產品銷售額約為 9 億美元。
Did you bring that down?
你把它弄下來了嗎?
I just want to make sure I heard that right.
我只是想確保我沒聽錯。
And I guess to what extent has pricing pressure in the business played or had an impact on your gross margins?
我猜想業務中的定價壓力在多大程度上影響或影響了您的毛利率?
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
Dipankar, new product sales?
Dipankar,新產品銷售?
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Yes, our new product sales, we had, even in earlier conversations, spoke about 80 different product opportunities.
是的,我們的新產品銷售,甚至在早期的談話中,談到了 80 種不同的產品機會。
That basket still remains the same.
那個籃子仍然保持不變。
Jami Rubin - Equity Analyst
Jami Rubin - Equity Analyst
Did you give us a total number?
你有給我們一個總數嗎?
I may have misheard you.
我可能聽錯了。
But I thought you had given us as a total number of $900 million, just want to square that with what you're saying today.
但我以為你給了我們總共 9 億美元,只是想把它與你今天所說的相提並論。
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
No, I don't believe so.
不,我不相信。
Kevin Mannix - Senior Vice President, Head of Investor Relations
Kevin Mannix - Senior Vice President, Head of Investor Relations
No, it was not $900 million.
不,這不是 9 億美元。
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
And then the second one, Jami, on the pricing pressure, it did not have an impact on our gross margin.
然後是第二個,Jami,關於定價壓力,它對我們的毛利率沒有影響。
I think that we said it in the prepared remarks, the gross profit margin of our U.S. business or U.S. generic business remains exactly the same.
我認為我們在準備好的評論中說過,我們美國業務或美國仿製藥業務的毛利率保持不變。
It's around 55% or a bit higher and did not suffer -- was not impacted by pricing pressure in generics in Q1.
它大約 55% 或更高一點,並且沒有受到影響——沒有受到第一季度仿製藥定價壓力的影響。
Operator
Operator
Your next question comes from the line of Andrew Finkelstein.
您的下一個問題來自 Andrew Finkelstein。
Andrew Finkelstein - Research Analyst
Andrew Finkelstein - Research Analyst
First off, just in fourth quarter, there were some one-time income from a deal with Takeda in Japan.
首先,就在第四季度,與武田在日本的交易中獲得了一些一次性收入。
Just curious if there were any proceeds from transactions like that in the current quarter.
只是好奇本季度是否有類似交易的收益。
And then if you could talk at all just about what you're seeing from the FDA in terms of improving the predictability of reviews for complex generics since there's a number of them that are a potentially meaningful swing factor in your second half results.
然後,如果你能談談你從 FDA 看到的關於提高複雜仿製藥審查的可預測性的內容,因為其中有許多是你下半年結果中潛在的有意義的搖擺因素。
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
Yes.
是的。
So in Q4, we included $150 million of sales from NINLARO product to Takeda.
因此,在第四季度,我們將 NINLARO 產品的 1.5 億美元銷售額計入了武田。
And this quarter, we included $75 million from the same source.
本季度,我們包括了來自同一來源的 7500 萬美元。
Andrew Finkelstein - Research Analyst
Andrew Finkelstein - Research Analyst
But no other transactions like that?
但沒有其他類似的交易嗎?
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
No.
不。
Hafrun Fridriksdottir - EVP and President of Global Generics R&D
Hafrun Fridriksdottir - EVP and President of Global Generics R&D
This is Hafrun speaking.
這是哈夫倫說話。
So with regards to working with the FDA and seeing some improvement in the time lines there specific for complex generics, we are clearly seeing much more activity from FDA than we saw in the past.
因此,關於與 FDA 合作並看到針對複雜仿製藥的時間表有所改進,我們顯然看到 FDA 的活動比我們過去看到的要多得多。
And we had been working very closely with them on some of the complex generics, which we have filed over the last few years.
我們一直在與他們密切合作,研究我們在過去幾年提交的一些複雜仿製藥。
So clearly, we are seeing improvements there.
很明顯,我們看到了那裡的改進。
Operator
Operator
Your next question comes from the line of Douglas Tsao.
您的下一個問題來自 Douglas Tsao。
Morgan G. Williams - Research Analyst
Morgan G. Williams - Research Analyst
This is Morgan Williams on for Doug.
這是道格的摩根威廉姆斯。
So I was just hoping, I have a few questions.
所以我只是希望,我有幾個問題。
Number one, number of competitors said that the consolidation in the customer base is beneficial to a large manufacturer of generics.
第一,許多競爭對手錶示,客戶群的整合有利於大型仿製藥製造商。
Are you seeing the same dynamics?
你看到同樣的動態嗎?
Just asking for some more color around your commentary on generic performance this quarter.
只是要求在您對本季度通用性能的評論中增加一些色彩。
And then secondly, just hoping you could maybe provide a little bit more background on the AUSTEDO launch strategy and more on your rationale for pricing the product at a discount to competitors.
其次,只是希望你能提供更多關於 AUSTEDO 發布策略的背景信息,以及更多關於你以低於競爭對手的價格定價產品的理由。
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Yes.
是的。
So first, let me take the question that you raised on customer consolidation.
所以首先,讓我來回答你提出的關於客戶整合的問題。
So while customer consolidation does raise some pressure on some of our generic manufacturers, we also see opportunities to increase our strategic partnership with our key customers.
因此,雖然客戶整合確實給我們的一些仿製藥製造商帶來了一些壓力,但我們也看到了加強與主要客戶的戰略合作夥伴關係的機會。
So our unique global reach, our broad portfolio and our deep R&D capability to bring a pipeline of new products will create strategic value for both us as well as our customers.
因此,我們獨特的全球影響力、廣泛的產品組合以及我們帶來一系列新產品的深厚研發能力將為我們和我們的客戶創造戰略價值。
Yitzhak Peterburg - Interim CEO, Interim President and Director
Yitzhak Peterburg - Interim CEO, Interim President and Director
Rob?
搶?
Robert Koremans - CEO of Global Specialty Medicines Group and President of Global Specialty Medicines Group
Robert Koremans - CEO of Global Specialty Medicines Group and President of Global Specialty Medicines Group
And on the question on AUSTEDO, so you heard from Yitzhak, we're really pleased with the initial feedback from the market.
關於 AUSTEDO 的問題,您從 Yitzhak 那裡聽到,我們對市場的初步反饋感到非常滿意。
It was a very good reaction from both patients, physicians and also payers.
患者、醫生和付款人的反應都非常好。
As you also know, we are developing this product and are awaiting approval into tardive dyskinesia.
如您所知,我們正在開發該產品,正在等待遲發性運動障礙的批准。
And so we've priced it to really meet with both ends of the spectrum in Huntington's and in tardive dyskinesia.
因此,我們將其定價為真正滿足亨廷頓氏症和遲發性運動障礙的兩端。
And we really believe that with this, we have an incredibly good value for all stakeholders, and initial feedback really confirms it.
我們真的相信,有了這個,我們對所有利益相關者都有非常好的價值,最初的反饋確實證實了這一點。
Michael R. Hayden - Chief Scientific Officer and President of Global Research & Development
Michael R. Hayden - Chief Scientific Officer and President of Global Research & Development
Also just to add one, Michael here.
也只是添加一個,邁克爾在這裡。
Why this is being so well received by both patients as well as physicians is the impact of this drug.
為什麼這受到患者和醫生的好評是這種藥物的影響。
Chorea really incapacitates these patients.
舞蹈症確實使這些患者喪失了能力。
This has major effects on chorea, also impacts swallowing and improves nutrition.
這對舞蹈病有重大影響,也會影響吞嚥和改善營養。
And these are well recognized as major impacts without the side effects that you see with tetrabenazine.
這些被公認為主要影響,沒有丁苯那嗪的副作用。
So overall, an excellent safety and efficacy profile for this product.
因此,總體而言,該產品具有出色的安全性和有效性。
Operator
Operator
Your next question comes from the line of David Amsellem.
您的下一個問題來自 David Amsellem。
David A. Amsellem - MD and Senior Research Analyst
David A. Amsellem - MD and Senior Research Analyst
So just first, on divestitures, just expanding on some of the earlier questions.
所以首先,關於資產剝離,只是擴展一些早期的問題。
So what's the rationale of your keeping the U.S. Oncology business but just divesting the European Oncology business, only bearing in mind that you don't really have a pipeline in Oncology?
那麼,您保留美國腫瘤業務但只是剝離歐洲腫瘤業務的理由是什麼,只是要記住您在腫瘤業務方面並沒有真正的管道?
So that's number one.
所以這是第一名。
And then second, anything new to say on the EpiPen generic?
其次,關於 EpiPen 仿製藥有什麼新的說法嗎?
And what are your expectations there?
你對那裡的期望是什麼?
Robert Koremans - CEO of Global Specialty Medicines Group and President of Global Specialty Medicines Group
Robert Koremans - CEO of Global Specialty Medicines Group and President of Global Specialty Medicines Group
This is Rob.
這是羅布。
I'm happy to talk about the U.S. Oncology business.
我很高興談論美國的腫瘤學業務。
It's very important business for us.
這對我們來說是非常重要的業務。
BENDEKA is really doing extremely well with almost a 98% conversion and doing extremely well there.
BENDEKA 確實做得非常好,轉化率幾乎達到 98%,並且在那裡做得非常好。
We have an important deal with Celltrion, where we will be launching in '18 and '19 2 biosimilars.
我們與 Celltrion 達成了一項重要協議,我們將在 18 和 19 年推出 2 種生物仿製藥。
So this really is a very important business and it fits perfectly with us.
所以這確實是一項非常重要的業務,它非常適合我們。
For Europe, what we see is it's different.
對於歐洲,我們看到的是不同的。
We have a different portfolio in Europe than in the U.S. and we just don't have enough of a pipeline to be able to feed neither the Oncology products itself and also the Pain products in there.
我們在歐洲的產品組合與在美國的產品組合不同,我們只是沒有足夠的管道來供應腫瘤產品本身和那裡的疼痛產品。
And we believe that someone else could be a better owner.
我們相信其他人可以成為更好的所有者。
And it would definitely help to decrease our debts there.
這肯定有助於減少我們在那裡的債務。
So we've taken the decision to try and divest this.
所以我們決定嘗試剝離這個。
But the onco for us, with the opportunity for the Celltrion products, is really important going forward.
但是對我們來說,擁有 Celltrion 產品的機會的 onco 對我們來說非常重要。
Hafrun Fridriksdottir - EVP and President of Global Generics R&D
Hafrun Fridriksdottir - EVP and President of Global Generics R&D
So a comment on EpiPen.
所以對 EpiPen 發表評論。
So this probably remains to be a top priority for Teva.
因此,這可能仍然是 Teva 的首要任務。
And this is one of the products which we are working very closely with the FDA on.
這是我們與 FDA 密切合作的產品之一。
We still see a meaningful opportunity for a true AB-rated generic here.
我們仍然在這裡看到一個真正的 AB 級仿製藥的有意義的機會。
And as a reminder, we have a settlement agreement with Mylan, which allows us to launch upon approval of our ANDA.
提醒一下,我們與 Mylan 簽訂了和解協議,允許我們在 ANDA 批准後啟動。
The outlook for this drug has not changed from prior statements, so we are targeting a launch in early 2018.
這種藥物的前景與之前的聲明相比沒有改變,因此我們的目標是在 2018 年初推出。
Operator
Operator
Your next question comes from the line of Ronny Gal.
您的下一個問題來自 Ronny Gal。
Aaron Gal - Senior Research Analyst
Aaron Gal - Senior Research Analyst
Actually, I'm going to try to sneak in 3. The first one is about cost reduction.
其實,我打算偷偷摸摸3個。第一個是關於降低成本的。
Eyal, how should we expect the cost -- the operating line to progress during the year?
Eyal,我們應該如何預期成本——運營線在這一年的進展?
You had a one-time benefit on SG&A this quarter.
您在本季度獲得了一次性的 SG&A 收益。
But if we kind of think about quarters 2, 3 or 4, should we just, from the outside, see ongoing reduction on those operating lines?
但是,如果我們考慮一下第 2、3 或 4 季度,我們是否應該從外部看到這些運營線的持續縮減?
Or should they be, in absolute numbers, roughly flat?
或者它們的絕對數量應該大致持平?
Second, the issue of selling respiratory.
二是銷售呼吸系統的問題。
You seem to have a little bit of air to breathe here with Advair true generics being delayed.
由於 Advair 真正的仿製藥被推遲,您似乎在這裡呼吸了一點空氣。
This looks like it's a contractual sales to the PBMs, or the big buyers.
這看起來像是對 PBM 或大買家的合同銷售。
Can you tell us where you stand on this?
你能告訴我們你在這方面的立場嗎?
And essentially, when should we see -- begin to see contribution for this product?
本質上,我們應該什麼時候看到——開始看到這個產品的貢獻?
Is it this year or only the 2018 contract?
是今年還是只有 2018 年的合同?
And last, to Sol, I guess, as a representative of the board, some of the discussions we're having on here on the investment side is whether the dividend should be suspended for a couple of years to bring down the debt level.
最後,對於索爾,我想,作為董事會的代表,我們在投資方面的一些討論是是否應該暫停股息幾年以降低債務水平。
And obviously, you guys had to struggle with this question as well.
顯然,你們也不得不為這個問題而苦苦掙扎。
Is it something that is -- that you'll consider under any circumstances?
是不是在任何情況下您都會考慮?
Or is it something that you've essentially rejected in an absolute sense?
或者它是你在絕對意義上基本上拒絕的東西?
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
So on cost reduction, we're progressing very well.
所以在降低成本方面,我們進展得很好。
A little better than our already pretty ambitious plan.
比我們已經相當雄心勃勃的計劃好一點。
So we are seeing the results.
所以我們看到了結果。
The company has reduced headcount by almost 5,000 employees since we closed the transaction with Actavis on August 2 and about 1,700 from the beginning of this year.
自我們於 8 月 2 日與阿特維斯完成交易以來,該公司已裁減了近 5,000 名員工,從今年年初開始裁減了約 1,700 名員工。
And the impact of that will be seen later on this year, it never happens on Q1, our people leave.
其影響將在今年晚些時候看到,它永遠不會發生在第一季度,我們的員工離開了。
We are also reducing expenses in the areas which are not headcount.
我們還減少了不屬於員工人數的領域的開支。
Of course, it's labor-related, more efficiencies of cost of goods sold.
當然,它與勞動力有關,銷售成本的效率更高。
So all this is going to be seen as the plan progresses throughout the year and will improve our operating margin.
因此,隨著該計劃全年的推進,所有這一切都將被視為,並將提高我們的營業利潤率。
We said, and I'll repeat it again, this is not a linear year.
我們說過,我會再重複一遍,這不是線性年份。
The second half is expected also to benefit from more launches of new product, mostly coming from the U.S. generic.
預計下半年還將受益於更多新產品的推出,主要來自美國仿製藥。
And a combination of both will improve the margin.
兩者的結合將提高利潤率。
Robert Koremans - CEO of Global Specialty Medicines Group and President of Global Specialty Medicines Group
Robert Koremans - CEO of Global Specialty Medicines Group and President of Global Specialty Medicines Group
Ronny, on your second question, we've actually started being active in the market just recently with the sales forces.
羅尼,關於你的第二個問題,實際上我們最近才開始與銷售人員一起活躍在市場上。
Key would be, as you indicated, the payers, right, and to really get on the right formulary access will take some time.
正如您所指出的,關鍵是付款人,正確的,並且真正獲得正確的處方集訪問將需要一些時間。
The recent news, today's news on -- or actually yesterday's news on Hikma will help, I think, also payers to see that what we have is a very effective offering.
最近的新聞,今天的新聞——或者實際上是昨天關於 Hikma 的新聞,我認為,也將有助於付款人看到我們所擁有的是非常有效的產品。
But we will only start to see real sales early quarter 3 for AirDuo RespiClick.
但我們只會在第三季度初開始看到 AirDuo RespiClick 的實際銷售。
And it's an experiment we're doing.
這是我們正在做的一個實驗。
I think it's a good, new innovative strategy.
我認為這是一個很好的、新的創新策略。
But it will not have an immediate ramp-up as we need to really make sure that we get formulary access.
但它不會立即增加,因為我們需要真正確保我們獲得處方集。
Sol J. Barer - Chairman of the Board
Sol J. Barer - Chairman of the Board
In terms of the dividend, as indicated, our policy hasn't changed.
如前所述,在股息方面,我們的政策沒有改變。
And as Eyal had mentioned, every quarter, we, as a board, evaluate paying the dividend.
正如 Eyal 所說,作為董事會,我們每個季度都會評估支付股息。
And obviously, this year, this quarter, we have said that we will pay the dividend.
顯然,今年,本季度,我們已經說過我們將支付股息。
I can't speculate under any circumstances what would happen.
我無法推測在任何情況下會發生什麼。
I think it's just suffice that at this point that our policy is the same and that we have met and we have paid a dividend.
我認為在這一點上,我們的政策是相同的,我們已經見面並支付了紅利就足夠了。
And in the future, every quarter we will do the same.
並且在未來,每個季度我們都會這樣做。
Operator
Operator
Your next question comes from the line of Umer Raffat.
您的下一個問題來自 Umer Raffat。
Umer Raffat - Senior MD and Fundamental Research Analyst
Umer Raffat - Senior MD and Fundamental Research Analyst
I have a few today, if I may.
如果可以的話,我今天有一些。
First, Dipankar, on generics, so you're tracking at guidance-like numbers but at lower margin.
首先,關於仿製藥的 Dipankar,因此您正在跟踪類似指導的數字,但利潤率較低。
So I want to understand how you're thinking about the strategy in generics.
所以我想了解您是如何考慮泛型策略的。
Is it a revenue number you're working towards or an operating profit number?
這是您正在努力的收入數字還是營業利潤數字?
On specialty maybe, maybe for Michael.
也許是專業,也許是邁克爾。
Michael, are you expecting the quarterly CGRP to work?
邁克爾,您希望季度 CGRP 能夠奏效嗎?
And if so, can you deliver it in a way which doesn't involve 3 separate injections every 3 months?
如果是這樣,您能否以不涉及每 3 個月單獨注射 3 次的方式交付它?
And then finally, for Eyal and Michael, I noticed your slides said your net debt-to-EBITDA this quarter was 4.49x.
最後,對於 Eyal 和 Michael,我注意到您的幻燈片顯示本季度您的淨債務與 EBITDA 之比為 4.49 倍。
And I also recall that your covenant requires you to be at 4.25x.
我還記得你的盟約要求你達到 4.25 倍。
So I just wanted to reconcile those 2. And finally, I just also want to push back a bit on counting NINLARO as revenues.
所以我只想調和這兩個。最後,我還想稍微推遲一下將 NINLARO 計入收入。
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Yes, thanks, Umer.
是的,謝謝,烏默爾。
So as regarding the generics question that you asked, we do look at a combination of both revenues and our margins and not one or the other.
因此,關於您提出的仿製藥問題,我們確實會考慮收入和利潤率的組合,而不是兩者之一。
As regarding the revenues, it's obviously a combination of what we see happening in our base business in the U.S., our new product launches that our strong R&D capabilities bring.
至於收入,這顯然是我們在美國的基礎業務中看到的情況,以及我們強大的研發能力帶來的新產品發布的結合。
And also we look at a combination of how our business moves within the U.S. and the non-U.
我們還研究了我們的業務如何在美國和非美國境內移動的組合。
S. because from a revenue standpoint, you do have to recall and remember that about 55% of our generics revenue comes from outside the U.S. As regarding -- in terms of what we would expect and how we will track for the rest of the year, we would expect the current levels of price erosion that we have spoken about will remain for the rest of the year.
S. 因為從收入的角度來看,您確實必須記住並記住,我們大約 55% 的仿製藥收入來自美國以外的地區。至於 - 就我們的預期以及我們將如何跟踪今年剩餘時間而言,我們預計我們所說的當前價格侵蝕水平將在今年剩餘時間內保持不變。
It is embedded in our forecast.
它包含在我們的預測中。
And our new product launch revenues, as I mentioned earlier in one of the questions, is we continue to look at that basket and we continue to look at the 40 to 50 launch opportunities that we have.
正如我之前在一個問題中提到的,我們的新產品發布收入是我們繼續關注那個籃子,我們繼續關注我們擁有的 40 到 50 個發布機會。
Michael R. Hayden - Chief Scientific Officer and President of Global Research & Development
Michael R. Hayden - Chief Scientific Officer and President of Global Research & Development
Thank you, Umer, for the question on Fremanezumab.
謝謝你,Umer,關於 Fremanezumab 的問題。
We're obviously optimistic about quarterly injection.
我們顯然對季度注入持樂觀態度。
We're the only company that actually is looking at both monthly and quarterly.
我們是唯一一家實際上同時關注月度和季度的公司。
And the reason we're having some optimism is the long half-life of this particular product that we've seen before with very low immunogenicity.
我們之所以感到樂觀,是因為這種特殊產品的半衰期很長,我們以前見過這種產品的免疫原性非常低。
So we're exploring this.
所以我們正在探索這個。
We expect to have the results of this before the end of June.
我們希望在 6 月底之前得到結果。
And we will be able to see whether a quarterly dose injected just quarterly would be sufficient to have the impact.
我們將能夠看到僅按季度注射的季度劑量是否足以產生影響。
We also note that our efficacy in the Phase II was the best in the class.
我們還注意到,我們在第二階段的療效是同類中最好的。
And so that also, together with the long half-life and low immunogenicity, gives us some optimism.
因此,加上半衰期長和免疫原性低,這也讓我們感到樂觀。
But data will be available for us to really assess this in the very near future.
但在不久的將來,我們將獲得數據來真正評估這一點。
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
Umer, regarding the covenant, the requirement right now is 5.25.
烏默爾,關於聖約,現在的要求是5.25。
So at 4.49, we are way below that.
所以在 4.49,我們遠遠低於這個數字。
By year-end, it will go to 4.25 and we see no problems or issues to comply with that.
到年底,它將達到 4.25,我們認為沒有任何問題或問題可以遵守。
Operator
Operator
Your next question comes from the line of David Risinger.
您的下一個問題來自 David Risinger。
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
And congrats, Eyal, and best of luck to you.
祝賀你,Eyal,祝你好運。
I have a couple of questions.
我有一些問題。
First, with respect to the $200 million in additional cost savings this year, is that a full year benefit to 2017 guidance?
首先,關於今年額外節省的 2 億美元成本,這是否對 2017 年的指導方針有利?
Second, with respect to the new product launches in 2017, I wasn't quite clear on that.
第二,關於2017年的新品發布,我不是很清楚。
Could you restate what amount of new product launch revenue you expect in 2017 in the U.S. and globally?
您能否重述您預計 2017 年在美國和全球範圍內的新產品發布收入?
And then finally, with respect to the CGRP, Michael, could you just update us on the Phase III readout timing and the timing of filing in the U.S. and EU?
最後,關於 CGRP,Michael,您能否向我們介紹第三階段的讀出時間以及在美國和歐盟提交申請的時間?
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
Thank you, David, for your kind words.
謝謝你,大衛,你的客氣話。
The additional $200 million in cost savings are included in our guidance.
額外的 2 億美元成本節省包含在我們的指導中。
They are not addition to the guidance.
它們不是指南的補充。
We reiterated the guidance, we reiterated the range.
我們重申了指導,我們重申了範圍。
This will help us to be within the range in face of some challenges that Yitzhak has mentioned in his introduction.
這將有助於我們在面對 Yitzhak 在他的介紹中提到的一些挑戰時處於範圍之內。
So we can't just take that and add it.
所以我們不能只是接受並添加它。
Michael R. Hayden - Chief Scientific Officer and President of Global Research & Development
Michael R. Hayden - Chief Scientific Officer and President of Global Research & Development
Thanks for the question, David.
謝謝你的問題,大衛。
With regard to results, so as I said, we're expecting the results for CGRP for both chronic and episodic migraine before the end of June.
關於結果,正如我所說,我們期待 CGRP 在 6 月底之前獲得慢性和發作性偏頭痛的結果。
We plan to file for the FDA before the end of '17.
我們計劃在 17 年底之前向 FDA 提交申請。
So this is a little earlier than we had stated previously.
所以這比我們之前所說的要早一點。
This reflects the fact that the trial is ending a little early because of the very rapid recruitment that occurred both for chronic as well as for episodic.
這反映了這樣一個事實,即試驗結束得有點早,因為慢性和偶發性的招募都非常迅速。
Just to remind you, of course, also this program also is using -- this is using CGRP antagonist as add-on therapy.
只是提醒你,當然,這個程序也在使用——這是使用 CGRP 拮抗劑作為附加療法。
So we're getting a lot of the real-world scenario evidence, which will provide a very unique piece of information that will yield great value to doctors.
所以我們得到了很多真實世界的場景證據,這將提供一個非常獨特的信息,將為醫生帶來巨大的價值。
And this will be important.
這將很重要。
And so we're expecting to be, depending on when Amgen files, second in episodic and potentially first for chronic, depending on Amgen's submission date.
因此,根據安進提交文件的時間,我們預計會成為情節性的第二名,並且可能是慢性的第一名,具體取決於安進的提交日期。
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
And you'll press release this in June, the data?
你會在六月發布這個,數據?
Michael R. Hayden - Chief Scientific Officer and President of Global Research & Development
Michael R. Hayden - Chief Scientific Officer and President of Global Research & Development
The moment we have top line results, this will be press released before the end of June.
一旦我們有了頂級結果,這將在 6 月底之前發布。
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
So I'll take the question on the new product launch revenues for generics.
因此,我將回答關於仿製藥新產品發布收入的問題。
And I will repeat what I had said earlier is that the number that I said was specific to our U.S. new product launches.
我將重複我之前所說的,我所說的數字是針對我們美國新產品發布的。
And we continue to look at our basket of 80 different product opportunities.
我們繼續關注我們的 80 種不同產品機會。
This should yield between what we expect as 40 to 50 launches, products where we have a high certainty because of clearance on legal, regulatory and our operational readiness.
這應該會在我們預期的 40 到 50 次發布之間產生,因為我們在法律、監管和運營準備方面獲得了高度確定性的產品。
Will we expect to bring approximately $500 million of revenue?
我們預計會帶來大約 5 億美元的收入嗎?
We do have a higher risk basket, which has higher risks around legal and regulatory.
我們確實有一個更高的風險籃子,它在法律和監管方面具有更高的風險。
And our ability to go beyond the $500 million, and to the extent we can, will depend on how we overcome these regulatory and legal and operational readiness barriers.
我們超過 5 億美元的能力,以及我們能做到的程度,將取決於我們如何克服這些監管、法律和運營準備障礙。
But these are revenues of new product launches that are specific to the U.S. We also have a substantial business outside of the U.S., which also has the product revenues which I did not allude to.
但這些是針對美國的新產品發布的收入。我們在美國以外也有大量業務,其中也有我沒有提到的產品收入。
But they will add to the $500 million that we have.
但它們將增加我們擁有的 5 億美元。
Operator
Operator
Your next question comes from the line of Liav Abraham.
您的下一個問題來自 Liav Abraham。
Liav Abraham - Director
Liav Abraham - Director
Just a couple of questions here.
這裡只是幾個問題。
Firstly, for Eyal, given the cash flow in the first quarter, I know you had made comments on the trajectory of cash flow throughout the remainder of the year.
首先,對於 Eyal,考慮到第一季度的現金流,我知道您已經對今年剩餘時間的現金流軌跡發表了評論。
But can you just confirm that you are also reaffirming your cash flow guidance for the year of $5.7 billion to $6.1 billion.
但您能否確認一下您也重申了 57 億至 61 億美元的年度現金流指導。
And secondly, and apologies for flogging a dead horse here, I know the question has been asked a few times.
其次,很抱歉在這裡鞭打一匹死馬,我知道這個問題已經被問過幾次了。
But my understanding is that in the past, you guided to $850 million of new product launches in the U.S. Are you no longer guiding to that number?
但我的理解是,過去,你指導美國推出 8.5 億美元的新產品。你現在不再指導這個數字了嗎?
Is it $500 million plus the option for an additional $350 million more?
是 5 億美元加上另外 3.5 億美元的選擇權嗎?
I just want to make sure on that, and again apologies, I know it's been asked.
我只是想確認一下,再次道歉,我知道有人問過了。
And then lastly, just a follow-on question on your covenants.
最後,關於你的盟約的後續問題。
There continues to be concern from investors on meeting your covenants and the covenant progression over the next couple of years.
投資者繼續擔心在未來幾年內履行您的契約和契約進展。
Would you consider renegotiating these in order to provide yourselves and perhaps the investment community with some more confidence and breathing room?
你會考慮重新談判這些,以便為自己和投資界提供更多的信心和喘息的空間嗎?
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
Yes.
是的。
So maybe I'll take the first and the third question, and then Dipankar will address the second one.
所以也許我會回答第一個和第三個問題,然後 Dipankar 會回答第二個問題。
So yes, we are reaffirming the cash flow guidance.
所以,是的,我們正在重申現金流指導。
And as I mentioned on the call, Q1 has a very unusual large number of one-time cash-related events that we don't expect to repeat later on this year.
正如我在電話會議上提到的那樣,第一季度有非常多的一次性現金相關事件,我們預計今年晚些時候不會重複。
But I also said, and I repeat that, that the year is not linear on business performance and cash flow alike in the second half, where we will be stronger than the first.
但我也說過,我再說一遍,下半年的業務表現和現金流量都不是線性的,我們將比上半年強。
Regarding covenants, we see no need to renegotiate or negotiate the covenants.
關於契約,我們認為沒有必要重新談判或協商契約。
So we believe that we'll meet them in the near and the long term.
因此,我們相信我們會在近期和長期與他們會面。
Liav Abraham - Director
Liav Abraham - Director
And apologies from my end just on the second question I asked on the generics, I think you guided to $750 million in the U.S. earlier at the Q4 earnings, not $850 million.
就我就彷製藥提出的第二個問題向我道歉,我認為您在第四季度早些時候的收益中指導美國達到了 7.5 億美元,而不是 8.5 億美元。
So I just wanted to clarify that.
所以我只是想澄清一下。
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Dipankar Bhattacharjee - CEO of Global Generic Medicines Group and President of Global Generic Medicines Group
Yes.
是的。
So thank you, Liav.
所以謝謝你,利亞夫。
So again, I will reiterate what I have said and how it relates to the number that you mentioned is that in the basket of products that we have, the ones that we have a very high certainty of launching because of clearances that we have from a legal and IP standpoint in the U.S. amounts to $500 million, right?
因此,我將再次重申我所說的以及它與您提到的數字的關係是,在我們擁有的一攬子產品中,由於我們從在美國的法律和知識產權角度為 5 億美元,對吧?
Beyond that, there are a number of opportunities that we continue to look at, okay, which has higher risk around legal and regulatory barriers.
除此之外,我們還會繼續關注許多機會,好吧,這些機會在法律和監管障礙方面的風險更高。
And our ability to get closer to the number that you're speaking about is the degree of success that we have in overcoming those.
我們接近你所說的數字的能力是我們在克服這些方面取得的成功程度。
Yitzhak Peterburg - Interim CEO, Interim President and Director
Yitzhak Peterburg - Interim CEO, Interim President and Director
And I want to make sure that we never said $850 million.
我想確保我們從未說過 8.5 億美元。
Liav Abraham - Director
Liav Abraham - Director
Correct.
正確的。
I said $750 million, I corrected myself.
我說 7.5 億美元,我糾正了自己。
Apologies for that.
對此表示歉意。
Operator
Operator
Your next question comes from the line of Vamil Divan.
您的下一個問題來自 Vamil Divan。
Vamil Kishore Divan - Senior Analyst
Vamil Kishore Divan - Senior Analyst
Just one on the pipeline, and then one back on the financials.
只有一個在管道上,然後一個在財務上。
You mentioned Laquinimod and the disappointing data there for RRMS.
你提到了拉奎尼莫德和令人失望的 RRMS 數據。
But you're continuing still on PPMS and also Huntington's.
但是您仍在繼續使用 PPMS 和 Huntington's。
I'm just curious if you have any updated thoughts in those 2 indications, and if your expectations are now lower for the products succeeding there?
我只是好奇您是否對這兩個適應症有任何更新的想法,以及您現在對在那裡成功的產品的期望是否更低?
And then I've just got a couple of e-mails here, so I just want to clarify also.
然後我剛剛收到了幾封電子郵件,所以我也想澄清一下。
You mentioned the added synergies you think you'll get from Actavis this year.
您提到了您認為今年將從阿特維斯獲得的額外協同效應。
And presumably, that's a boost to your full year outlook.
據推測,這對您的全年前景有所提振。
What is sort of the offsets that's kind of keeping your full year outlook the same?
什麼樣的補償能讓你的全年展望保持不變?
Is it more of the FX in Venezuela?
委內瑞拉的外匯更多嗎?
Is there any other factors?
還有其他因素嗎?
Is it the margins?
是邊緣嗎?
What's sort of leading to the outlook to remain the same despite that added synergies?
儘管增加了協同效應,是什麼導致前景保持不變?
Michael R. Hayden - Chief Scientific Officer and President of Global Research & Development
Michael R. Hayden - Chief Scientific Officer and President of Global Research & Development
Thank you, Vamil, Michael here.
謝謝你,瓦米爾,邁克爾在這裡。
Just to give a quick update on Laquinimod.
只是為了快速更新一下 Laquinimod。
Of course, we were disappointed with the failure to achieve the primary endpoint, which is confirmed disease progression.
當然,我們對未能達到主要終點(即確認的疾病進展)感到失望。
But we were interested in the secondary results, which showed a 40% decrease in brain atrophy, a 28% decrease in time to first relapse and also a 25% decrease in relapse rate.
但我們對次要結果感興趣,該結果顯示腦萎縮減少了 40%,首次復發的時間減少了 28%,復發率也減少了 25%。
So this confirmed the neuroprotective effect of Laquinimod.
所以這證實了拉喹莫德的神經保護作用。
And as such, the study on progressive MS, which is a disease much more progressive to brain atrophy, we're expecting those results in the third quarter.
因此,關於進行性 MS 的研究,這是一種更容易導致腦萎縮的疾病,我們期待在第三季度獲得這些結果。
And the Huntington's study, which is ongoing, will continue to a readout next year.
亨廷頓的研究正在進行中,明年將繼續進行讀數。
The reason we're continuing is that certainly we've seen the neuroprotective effect.
我們繼續的原因是我們當然已經看到了神經保護作用。
There's data from other studies.
有其他研究的數據。
We understand the mechanism.
我們了解機制。
And these studies are in full progress, fully recruited.
而這些研究正在全面進行中,全部被招募。
And so these will be continued to their endpoint.
所以這些將持續到它們的終點。
Of course, progressive MS, I think, we have lower expectations based on the results in relapsing-remitting.
當然,進步的 MS,我認為,基於復發緩解的結果,我們的期望值較低。
Operator
Operator
Your final question comes from the line of Chris Schott.
您的最後一個問題來自 Chris Schott。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
Just one coming back on generic gross margins.
只有一個以通用毛利率回歸。
I think the earlier comments you said that we could think about some modest improvements from these Q1 levels as the year progressed.
我認為你之前的評論說,隨著時間的推移,我們可以考慮從這些第一季度的水平上進行一些適度的改進。
Can you elaborate a bit about longer-term trends on margins?
您能否詳細說明利潤率的長期趨勢?
Basically, where do you see generic gross margins moving longer term, given some of the adjustments we had with the Venezuela business, et cetera?
基本上,考慮到我們對委內瑞拉業務等進行的一些調整,您認為一般毛利率會在哪裡移動?
My second question was on the 3 businesses that you're looking to divest.
我的第二個問題是關於您希望剝離的 3 項業務。
Can you just help us a little bit in terms of the size and the profitability of those business?
你能在這些業務的規模和盈利能力方面幫助我們一點嗎?
I know you break out the Women's Health sales.
我知道你打破了女性健康銷售。
Can you give us the sales on the EU Oncology and Pain franchises?
你能告訴我們歐盟腫瘤和疼痛特許經營的銷售額嗎?
And how do we think about margins for those businesses?
我們如何看待這些業務的利潤率?
I guess should we think about margins in line with your overall Specialty franchise?
我想我們應該考慮與您的整體專業特許經營權一致的利潤率嗎?
Should we think about just what could happen with the P&L as those potentially go away?
我們是否應該考慮在損益表可能消失時會發生什麼?
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
So gross margin on Generic, we expect that to go back to the level that we've seen in the past few quarters, 48%, 49% later on this year.
因此,Generic 的毛利率,我們預計它將回到我們在過去幾個季度看到的水平,即今年晚些時候的 48% 和 49%。
This is based on both higher margin products that we intend to sell, launching new products that always come with higher margins and of course, cost reduction improvement from the other side.
這是基於我們打算銷售的利潤率更高的產品,推出總是具有更高利潤率的新產品,當然還有另一方的成本降低改進。
Both of them are going to improve gross margin and operating profit margins that we expect it will be around 29%, 30% for the year to complement the higher gross margin that we will experience later on.
他們都將提高毛利率和營業利潤率,我們預計今年將達到 29% 和 30% 左右,以補充我們稍後將經歷的更高的毛利率。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
And just as a quick follow-up, is that 29% to 30%, is that a good run rate going forward?
就像快速跟進一樣,是 29% 到 30%,這是一個很好的運行率嗎?
Or can you give us a little bit of thoughts about just as we think about the longer-term progression of generics?
或者你能給我們一些想法,就像我們思考仿製藥的長期發展一樣?
Is that a good run rate?
這是一個很好的運行率嗎?
Or should that continue to improve over time?
還是應該隨著時間的推移繼續改善?
Eyal Desheh - CFO and Group EVP
Eyal Desheh - CFO and Group EVP
Yes, I don't want to talk to the much longer term.
是的,我不想談論更長的時間。
But when we're talking about 2017, these are the run rates that we assume.
但是當我們談論 2017 年時,這些是我們假設的運行率。
Robert Koremans - CEO of Global Specialty Medicines Group and President of Global Specialty Medicines Group
Robert Koremans - CEO of Global Specialty Medicines Group and President of Global Specialty Medicines Group
And Chris, this is Rob.
克里斯,這是羅伯。
On your question to the Women's Health business, it's about $560 million in revenues and has a very good and healthy contribution.
關於您對女性健康業務的問題,它的收入約為 5.6 億美元,並且有非常好的和健康的貢獻。
And the same is true for the onco, pain in Europe.
歐洲的腫瘤疼痛也是如此。
It's about $360 million in revenues in '16 and again very, very contribution margins.
16 年的收入約為 3.6 億美元,利潤率也非常非常高。
So should be very attractive assets to divest and not only on the Women's Health.
所以應該是非常有吸引力的資產剝離,而不僅僅是女性健康。
These are businesses that doesn't strongly depend on R&D impact and it's very sustainable products.
這些業務並不強烈依賴研發影響,而且是非常可持續的產品。
And I think a new buyer will really also benefit from them.
而且我認為新買家也會真正從中受益。
Yitzhak Peterburg - Interim CEO, Interim President and Director
Yitzhak Peterburg - Interim CEO, Interim President and Director
Okay.
好的。
So I want to thank all of you for your participation, see you most probably in the next quarter.
所以我要感謝大家的參與,很可能下個季度見。
Good luck, everybody.
祝大家好運。
Good morning.
早上好。
Operator
Operator
Thank you.
謝謝你。
This does conclude our conference for today.
這確實結束了我們今天的會議。
Thank you for participating.
感謝您的參與。
You may all now disconnect.
你們現在都可以斷開連接了。