使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Teva reports first-quarter 2016 financial results conference call.
女士們,先生們,感謝你們的支持,歡迎來到 Teva 報告 2016 年第一季度財務業績電話會議。
I would now like to turn the conference over to the Head of Investor Relations, Kevin Mannix.
我現在想將會議轉交給投資者關係主管 Kevin Mannix。
Please go ahead.
請繼續。
Kevin Mannix - Head of IR
Kevin Mannix - Head of IR
Thank you, Operator.
謝謝你,運營商。
Good morning, and good afternoon, everyone.
大家早上好,下午好。
Thank you for joining us today to discuss Teva's first-quarter 2016 financial results.
感謝您今天加入我們討論 Teva 2016 年第一季度的財務業績。
On the call with me today are Erez Vigodman, Chief Executive Officer; Eyal Desheh, Chief Financial Officer; Siggi Olafsson, President and CEO, Global Generic Medicines; Dr. Rob Koremans, President and CEO, Global Specialty Medicines; Dr. Michael Hayden, Head of R&D, Chief Scientific Officer; Dr. Carlo De Notaristefani, President and CEO Global Operations; and David Stark, Senior Vice President and Deputy General Counsel.
今天與我通話的是首席執行官 Erez Vigodman; Eyal Desheh,首席財務官;全球仿製藥公司總裁兼首席執行官 Siggi Olafsson; Global Specialty Medicines 總裁兼首席執行官 Rob Koremans 博士; Michael Hayden 博士,研發主管、首席科學官;全球運營總裁兼首席執行官 Carlo De Notaristefani 博士;高級副總裁兼副總法律顧問 David Stark。
We will start the call with presentations from Erez, Siggi, and Eyal before opening up the call up for questions and answers.
我們將以 Erez、Siggi 和 Eyal 的演講開始電話會議,然後再開始電話問答。
A copy of this slides, as well as this morning's earnings press release can be found on our website, tevapharm.com, under the Investor Relations section, as well as on the Teva Investor Relations app.
可以在我們的網站 tevapharm.com 的“投資者關係”部分以及 Teva 投資者關係應用程序上找到此幻燈片的副本以及今天上午的收益新聞稿。
During this call, we will be making forward-looking statements, which are predictions, projections or other statements about future events.
在此次電話會議中,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 Teva 業績的預期。
Actual results may vary, whether as a result of exchange rate differences, market conditions, or other factors.
實際結果可能會因匯率差異、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 GAAP 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 the results 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 數據是 Teva 管理層和董事會用來評估公司運營績效的結果,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 supplemental data, and not in substitution or replacement for GAAP results.
Teva 向投資者提供此類非 GAAP 數據作為補充數據,不能替代或替換 GAAP 結果。
We, as Management, believe such data provides useful information to investors.
作為管理層,我們相信這些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 CEO, Erez Vigodman.
有了這個,我現在將把電話轉給我們的首席執行官 Erez Vigodman。
Erez?
埃雷茲?
Erez Vigodman - CEO
Erez Vigodman - CEO
Thank you, Kevin.
謝謝你,凱文。
Good morning, good afternoon, and thank you for joining us today.
早上好,下午好,感謝您今天加入我們。
Our results for the first quarter of 2016 manifests a good start to the year on all the parameters.
我們 2016 年第一季度的業績在所有參數上都為今年開了個好頭。
Despite a tough comparable quarter in Q1 2015, with the launch of generic Nexium, and the exclusivity we had on generic Pulmicort.
儘管 2015 年第一季度的可比季度很艱難,但隨著仿製藥 Nexium 的推出,以及仿製藥 Pulmicort 的排他性。
EPS for Q1 2016 is $1.20, at the top end of our quarterly guidance.
2016 年第一季度每股收益為 1.20 美元,處於我們季度指引的上限。
We have improved our profitability, profit margin by 144 basis points, and operating margin by 101 basis points.
我們的盈利能力、利潤率提高了 144 個基點,營業利潤率提高了 101 個基點。
Cash flow from operations in the quarter was a robust $1.38 billion.
本季度運營產生的現金流量為 13.8 億美元。
Our solid performance was driven by continual improvement of our core business, with a strong focus on profitability, cost control, and portfolio optimization.
我們的穩健業績得益於我們核心業務的持續改進,重點關注盈利能力、成本控制和投資組合優化。
Additionally, our performance was driven by our operational network transformation, which creates value by driving efficiencies further, and through the assimilation of new technologies including in biologics.
此外,我們的業績是由我們的運營網絡轉型推動的,該轉型通過進一步提高效率以及吸收包括生物製劑在內的新技術來創造價值。
Finally, we enhanced our performance of all our business units, including Europe, Tapi, and OTC in our global generic business, and respiratory in our global specialty business.
最後,我們提高了所有業務部門的績效,包括我們全球仿製藥業務中的歐洲、Tapi 和 OTC,以及我們全球專業業務中的呼吸。
Copaxone 40 milligram continued to gain market share, leading the MS market with 24.5% TRx share at the end of March, versus 20.3% at the end of March 2015, and 82% share of the overall Copaxone family TRx.
40 毫克 Copaxone 繼續獲得市場份額,在 MS 市場中以 24.5% 的 TRx 份額領先於 3 月底,而 2015 年 3 月底為 20.3%,在整個 Copaxone 系列 TRx 中的份額為 82%。
We also launched BENDEKA at the end of January, and have achieved a patient adoption rate of 71% as of May 5, 2016.
我們還在 1 月底推出了 BENDEKA,截至 2016 年 5 月 5 日,患者採用率已達到 71%。
Our global generics business generated 26.9% operating margin in the quarter, without major new launches in the US and other key markets.
我們的全球仿製藥業務在本季度產生了 26.9% 的營業利潤率,美國和其他主要市場沒有推出新的重大產品。
We also saw significant progress in our global respiratory business, net revenues and operating profits, and 21% higher operating profits of our global specialty business quarter over quarter.
我們還看到我們的全球呼吸業務、淨收入和營業利潤取得了重大進展,我們的全球專業業務季度營業利潤環比增長了 21%。
During Q1, we continued to strengthen our specialty business through the launch of CINQAIR.
在第一季度,我們通過推出 CINQAIR 繼續加強我們的專業業務。
We also achieved successful results in three important Phase 3 trials including RespiClick FS and FP, which utilize our core breath-actuated multi-dose dry powder inhaler and QVAR BAI.
我們還在包括 RespiClick FS 和 FP 在內的三個重要的 3 期試驗中取得了成功的結果,它們利用了我們的核心呼吸驅動多劑量乾粉吸入器和 QVAR BAI。
Additionally, we are on track with our TV-84125 Phase 3 trials on both episodic and chronic migraine.
此外,我們正在進行針對發作性和慢性偏頭痛的 TV-84125 3 期試驗。
We also achieved significant milestones on the deals we announced in 2015.
我們還在 2015 年宣布的交易中取得了重要的里程碑。
We closed the acquisition of Rimsa in Mexico.
我們完成了對墨西哥 Rimsa 的收購。
On April 1, we closed the business venture with Takeda in Japan, and we have made significant progress towards closing the Actavis Generics deal, and we are on track for a June 2016 close.
4 月 1 日,我們結束了與武田在日本的業務合資,我們在完成 Actavis Generics 交易方面取得了重大進展,我們有望在 2016 年 6 月完成交易。
Siggi will provide an additional update on this shortly.
Siggi 將很快就此提供額外的更新。
Everything we are doing in 2016 will enable us to fundamentally change the Company, and complete the creation of a new Teva.
我們在 2016 年所做的一切將使我們能夠從根本上改變公司,並完成創建新的 Teva。
Before the end of 2016, which is a transition year for us, Teva will be an even stronger company with a solidified foundation, a significantly enhanced financial profile, more diversified revenue sources and profit streams, strong product development engines in both generics and specialty, and positioned to continue the transformation of our business model.
在 2016 年底之前,也就是我們的過渡年,Teva 將成為一家更加強大的公司,擁有堅實的基礎、顯著增強的財務狀況、更加多元化的收入來源和利潤流、強大的仿製藥和專科產品開發引擎,並定位於繼續轉變我們的商業模式。
Post the Actavis Generics acquisition, Teva will serve approximately 250 million people every day.
在收購 Actavis Generics 後,Teva 每天將為大約 2.5 億人提供服務。
And as the world's largest medicine cabinet with more than 1,000 molecules, we will have one of the most competitive fully integrated operational platforms in the industry that cover the full spectrum of products, from volume generics to complex generics, and all the way to specialty medicine and biologics.
作為全球最大的擁有 1000 多個分子的藥櫃,我們將擁有業內最具競爭力的全集成運營平台之一,涵蓋從批量仿製藥到復雜仿製藥,一直到專科藥的全系列產品和生物製品。
Both the US and global generic markets present huge opportunities in the coming years.
美國和全球仿製藥市場在未來幾年都存在巨大機遇。
The platform we are creating is ideally positioned to enter in the evolving generic pricing landscape by leveraging our global infrastructure and deployment, go-to-market platform, leading product portfolio, and industry-leading pipeline and R&D capabilities.
我們正在創建的平台非常適合通過利用我們的全球基礎設施和部署、上市平台、領先的產品組合以及行業領先的管道和研發能力進入不斷發展的仿製藥定價領域。
By the same time, we are well-positioned to realize the opportunities that our global and US generic markets offer, especially given the challenges and the changes we are witnessing in the various competitive landscapes for the benefit of patients, healthcare systems, and our investors.
與此同時,我們處於有利地位,可以實現我們的全球和美國仿製藥市場提供的機會,特別是考慮到我們在各種競爭格局中為患者、醫療保健系統和我們的投資者的利益目睹的挑戰和變化.
We'll address that with more details later on.
我們稍後會詳細介紹這個問題。
And last but not least, the Company's strong combined free cash flow would allow for rapid deleveraging.
最後但同樣重要的是,公司強大的綜合自由現金流將允許快速去槓桿化。
And as we have previously stated, give us the ability to pursue acquisitions of attractive branded and pipeline assets, as well as ones that would expand our footprint in key growth markets.
正如我們之前所說,這使我們能夠收購有吸引力的品牌和管道資產,以及能夠擴大我們在關鍵增長市場的足蹟的資產。
The platform we are building offers top and bottom line growth opportunities, even if we were to face generic competition to Copaxone 40 milligrams, also driven by the expected launches of our major specialty products in 2017, 2018, and beyond.
我們正在構建的平台提供了頂線和底線增長機會,即使我們將面臨針對 Copaxone 40 毫克的仿製藥競爭,這也受到我們預計在 2017 年、2018 年及以後推出的主要專業產品的推動。
All of us at Teva are fully aligned around our key priorities for 2016, which are a combination of maintaining business continuity, fully achieving our short-term operational and financial goals, and moving ahead on longer-term strategic moves that ultimately creates the new Teva.
Teva 的所有人都圍繞我們 2016 年的主要優先事項完全一致,這些優先事項包括保持業務連續性、全面實現我們的短期運營和財務目標,以及推進最終創建新 Teva 的長期戰略舉措.
To sum it up, we are focused on defending Copaxone and BENDEKA, on the continued transformation of our operation and network, around cost controls, efficiency measures, and 2016 operational and financial targets.
總而言之,我們專注於捍衛 Copaxone 和 BENDEKA,專注於我們的運營和網絡的持續轉型,圍繞成本控制、效率措施以及 2016 年運營和財務目標。
We also continue to focus on our integration and synergies.
我們還繼續關注我們的整合和協同效應。
We commenced the integration of Rimsa and the new business venture in Japan.
我們開始整合 Rimsa 和日本的新業務。
We are prepared for the Actavis Generics integration, and we are working hard to close the deal in June.
我們為 Actavis Generics 整合做好了準備,我們正在努力在 6 月份完成交易。
2016 is another important year for our specialty pipeline, with important pending approvals in key clinical milestones.
2016 年對於我們的專業管線來說又是重要的一年,在關鍵的臨床里程碑中有重要的待批准。
We are awaiting FDA approval for our abuse-deterrent extended-release hydrocodone, our abuse-deterrent technology is a platform for us and we are focusing our efforts in this field on the development and growth of a responsible pain care franchise to help address the challenges of opioid abuse and misuse.
我們正在等待 FDA 批准我們的防濫用緩釋氫可酮,我們的防濫用技術是我們的一個平台,我們正在將我們在這一領域的努力集中在負責任的疼痛護理特許經營權的發展和壯大上,以幫助應對挑戰阿片類藥物濫用和濫用。
TV-46763 is the immediate release abuse deterrent hydrocodone product, which is generated from our novel abuse deterrent technology.
TV-46763 是立即釋放的濫用威懾氫可酮產品,它是從我們的新型濫用威懾技術中產生的。
Phase 3 top-line results are expected in Q2 and our application submission in 2016.
預計第 3 階段的頂級結果將在第二季度和我們在 2016 年提交的申請中公佈。
We are awaiting FDA approval for our SD-809 in Huntington's disease, and expect results in 2016 from Phase 3 of our SD-809 in Tardive dyskinesia, and from Phase 2 of Pridopidine in Huntingtons.
我們正在等待 FDA 批准我們的 SD-809 用於治療亨廷頓氏病,並期待 2016 年我們的 SD-809 治療遲發性運動障礙的第 3 期和治療亨廷頓氏病的 Pridopidine 的第 2 期結果。
In addition we are focused on strengthening our biologics capabilities, and targeting potential partners within advanced biosimilar programs, in order to bolster our biosimilar portfolio.
此外,我們專注於加強我們的生物製劑能力,並在先進的生物仿製藥項目中瞄準潛在合作夥伴,以加強我們的生物仿製藥產品組合。
We are active in identifying specific specialty branded deals that complement and enhance our core TAs, and deals that expand our footprint in key growth markets.
我們積極尋找特定的專業品牌交易來補充和增強我們的核心 TA,以及擴大我們在主要增長市場的足蹟的交易。
Finally, we continue to gradually transform our business model in a way that enables us to benefit from the ongoing changes in the pharmaceutical industry and the global health care space.
最後,我們繼續逐步轉變我們的商業模式,使我們能夠從製藥行業和全球醫療保健領域的持續變化中受益。
That's the way we see our business outlook during the next few months, in the context of the upcoming Actavis Generics deal close.
在即將完成的 Actavis Generics 交易的背景下,這就是我們對未來幾個月業務前景的看法。
We continue to expect and work towards the June closing with Actavis Generics, and in August as part of our Q2 earnings, we'll provide the combined outlook for 2016.
我們繼續期待 Actavis Generics 的 6 月收盤,並在 8 月作為我們第二季度收益的一部分,我們將提供 2016 年的綜合展望。
Then in September, we'll provide you with our business and financial outlook for full year 2017 and full year 2018.
然後在 9 月,我們將為您提供 2017 年全年和 2018 年全年的業務和財務展望。
With that, I would like to thank you again, and turn the call over to Siggi.
有了這個,我想再次感謝你,並將電話轉給 Siggi。
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
Thanks, Erez.
謝謝,埃雷茲。
Good morning, and good afternoon, everyone.
大家早上好,下午好。
The global generic drug market has no shortage of manufacturers supplying vital medicines to patients in the US and around the world.
全球仿製藥市場不乏為美國和世界各地的患者提供重要藥物的製造商。
As a result, there is endless commentary and interpretation of the operating conditions that we, as an industry, are operating under.
因此,對於我們作為一個行業所處的經營條件,有無窮無盡的評論和解釋。
This can make it extremely difficult to identify and understand the specific opportunities and risks for each company in the sector, and for the industry as a whole.
這使得識別和理解該行業中每家公司以及整個行業的具體機會和風險變得極其困難。
As you know, in February, during the fourth-quarter reporting season, several industry participants referenced a tougher pricing environment than what they have experienced in previous years, as a reason for the softness in their respective generic businesses.
如您所知,在 2 月份的第四季度報告季,一些行業參與者提到了比往年更艱難的定價環境,這是他們各自仿製藥業務疲軟的原因。
Now, we fast-forward to April and May, to a new reporting season, and we find the number of companies citing a tougher pricing environment or price deflation seems to have grown at an almost incredible rate.
現在,我們快進到 4 月和 5 月,進入新的報告季,我們發現以更嚴峻的定價環境或價格通縮為由的公司數量似乎以幾乎令人難以置信的速度增長。
The referencing of generic drug price deflation has not been limited to the manufacturers, but is also being cited by those on the purchasing and distribution side, leaving many to wonder about what is the real opportunity in generics.
仿製藥價格下跌的說法不僅限於生產企業,也被採購和分銷方引用,讓許多人懷疑仿製藥的真正機會在哪裡。
As always, I will do my best to provide you with as much color as possible on what Teva is experiencing, in regards to pricing and volume; and more importantly, where we are headed.
一如既往,我將盡我所能為您提供盡可能多的關於 Teva 正在經歷的事情的顏色,關於定價和數量;更重要的是,我們要去哪裡。
Throughout the ongoing debate this year about the level of generic price erosion in the United States, Teva has been very consistent and clear with investors.
在今年關於美國仿製藥價格下降程度的持續辯論中,Teva 一直與投資者保持一致和明確的態度。
Teva has not seen any fundamental change or worsening in the pricing environment -- something we have been consistent about telling investors all year.
Teva 沒有看到定價環境有任何根本性變化或惡化——我們一整年都在告訴投資者這一點。
Teva experienced approximately 4% price erosion in the United States last year, and our guidance for this year is that it will remain the same.
Teva 去年在美國經歷了大約 4% 的價格下跌,我們今年的指導意見是保持不變。
In fact, Allergan, and Mylan, two other companies with broad and diversified portfolios and high quality products, have also reported similar trends.
事實上,艾爾建和邁蘭這兩家擁有廣泛多元化產品組合和高質量產品的公司也報告了類似的趨勢。
From where I sit today, there is nothing that changes my mind about that.
從我今天的位置來看,沒有什麼能改變我的想法。
Nothing has happened in the last two quarters that has changed the pricing environment.
過去兩個季度沒有發生任何改變定價環境的事情。
What this boils down to is each individual company's business model, and I'll explain that further in a few minutes.
這歸結為每個公司的商業模式,我將在幾分鐘後進一步解釋。
Additionally, we have heard from many of the companies in this sector that consolidation of the customers is having an impact on the pricing environment.
此外,我們從該行業的許多公司那裡聽說,客戶整合正在對定價環境產生影響。
Of course, this consolidation creates pressure on generic manufacturers, but there has been no meaningful change in the last two quarters.
當然,這種整合給仿製藥製造商帶來了壓力,但過去兩個季度並沒有發生任何有意義的變化。
We believe we have already reached a new status quo with the big customers; the fees and charges resulting from the customer consolidations are more or less already built into the pricing of the products when most of the consolidation took effect 24 months ago.
我們相信我們已經與大客戶達成了新的現狀;當大部分合併在 24 個月前生效時,客戶合併產生的費用或多或少已經包含在產品定價中。
Overall, Teva's generic business in the first quarter 2016 performed extremely well.
總體而言,Teva 的仿製藥業務在 2016 年第一季度表現極為出色。
The operating profit compared to last quarter improved by 140 basis points from 25.5% in the fourth quarter 2015, to 26.9% in the first quarter 2016.
與上一季度相比,營業利潤從 2015 年第四季度的 25.5% 提高到 2016 年第一季度的 26.9%,提高了 140 個基點。
When compared to first quarter 2015, the operating profit declined by 360 basis points, fully explained by the exclusive launch of generic Nexium, esomeprazole, in the first quarter 2016.
與 2015 年第一季度相比,營業利潤下降了 360 個基點,這充分說明了耐信在 2016 年第一季度獨家推出仿製藥埃索美拉唑的原因。
Excluding the exclusivity period of esomeprazole in first quarter, the profit margin of the generic segment was 24.4%.
剔除第一季度埃索美拉唑的獨占期,仿製藥板塊的利潤率為 24.4%。
So why is Teva different?
那麼為什麼 Teva 與眾不同呢?
Why is our performance better than most generic companies?
為什麼我們的業績優於大多數仿製藥公司?
Why are other companies continuing to say, there is a pricing pressure greater than what we at Teva are seeing?
為什麼其他公司繼續說,定價壓力比我們在 Teva 看到的更大?
I see three reasons: first, the companies with older portfolio seemed to complain much more loudly.
我看到三個原因:首先,投資組合較老的公司似乎抱怨得更大聲。
What I mean by that is, that if you look carefully at some companies with older portfolios, they will tell you that the pricing environment is worsening.
我的意思是,如果你仔細觀察一些投資組合較舊的公司,他們會告訴你定價環境正在惡化。
But this is not an environment.
但這不是一個環境。
This is purely a reflection of their portfolios, some of which are concentrated in one, or very few, therapeutic classes that are experiencing normal competition.
這純粹是他們產品組合的反映,其中一些產品集中在一個或很少的幾個正在經歷正常競爭的治療類別中。
This takes me to the second factor, new product launches.
這將我帶到第二個因素,新產品發布。
When companies don't have new product launches, and the business is declining, they tend to talk about the market more than anything else.
當公司沒有新產品發布,業務下滑時,他們往往會談論市場而不是其他任何事情。
This is not a reflection of the environment, but rather again, a reflection on a company's portfolio.
這不是對環境的反映,而是對公司投資組合的反映。
The third factor is companies that are trying to grow their market share.
第三個因素是試圖擴大市場份額的公司。
Some companies are aggressive in going after market share for a variety of reasons, including to utilize excess capacity with relatively cheap volume.
一些公司出於各種原因積極爭取市場份額,包括以相對便宜的數量利用過剩產能。
But in order to do that, you'll have to drive down price.
但為了做到這一點,你必須壓低價格。
Buying new market share in price will cost you on the bottom line.
以價格購買新的市場份額將使您付出代價。
We, on the other hand, are seeing our volumes go down, deliberately, net-net approximately 1% a year, because we think that is better for our business, and we would rather reduce capacity, than fill it with less profitable products.
另一方面,我們看到我們的銷量有意下降,每年淨值下降約 1%,因為我們認為這對我們的業務更好,我們寧願減少產能,也不願用利潤較低的產品來填充它。
So if you look at this slide, you'll see that over the past few years, we discontinued 70 products.
所以如果你看這張幻燈片,你會發現在過去的幾年裡,我們停產了 70 種產品。
At the same time, we introduced 68 new ones in the US.
同時,我們在美國推出了68個新產品。
So how does the growth formula work?
那麼增長公式是如何運作的呢?
Our simplified business model formula is as follows: approximately 10% growth from new products, minus approximately 5% erosion, which includes price erosion of approximately 3% to 4%, and volume decline of approximately 1% to 2%.
我們簡化的商業模型公式如下:新產品帶來約 10% 的增長,減去約 5% 的侵蝕,其中包括約 3% 至 4% 的價格侵蝕,以及約 1% 至 2% 的銷量下降。
This equals mid-single-digit of 5% growth in Teva generic business.
這相當於 Teva 仿製藥業務增長 5% 的中個位數。
It could be 7% in a specific year, and 4% in another year, but this is the basic formula in trying to understand our business.
某一年可能是 7%,另一年可能是 4%,但這是試圖了解我們業務的基本公式。
The business model may seem simple, but not easy to duplicate.
商業模式看似簡單,但不易複製。
Teva needs to grow by 10% every year with new product launches, and this is the key.
Teva 每年需要通過新產品的推出實現 10% 的增長,這是關鍵。
This is the basis of any good generic business model.
這是任何良好的通用商業模式的基礎。
How do you do that?
你是怎樣做的?
It comes down to the right portfolio selection, and smart investment.
這歸結為正確的投資組合選擇和明智的投資。
Teva and Actavis Generics are the leaders in this field.
Teva 和 Actavis Generics 是該領域的領導者。
Each company invests approximately $425 million in generic R&D and regulatory affairs.
每家公司在仿製藥研發和監管事務上的投資約為 4.25 億美元。
While we won't maintain an annual generic R&D budget of $850 million after combining the two companies, the spend level will still be both significant and industry-leading, enabling us to achieve 10% growth a year.
兩家公司合併後,雖然我們不會維持 8.5 億美元的年度通用研發預算,但支出水平仍將是巨大的和行業領先的,使我們能夠實現每年 10% 的增長。
We intend to maintain the leadership position here.
我們打算在這裡保持領導地位。
At the end of the day, the key to growth in generics has been, and always will be new product launches, which are the only true live source for successful companies.
歸根結底,仿製藥增長的關鍵一直是並將永遠是新產品的發布,這是成功公司唯一真正的實時來源。
Teva had approximately 450 global launches in 2015.
Teva 在 2015 年在全球推出了大約 450 款產品。
For 2016, on a full-year pro forma basis with Actavis Generics, we see over 1,000 new product launches growing to approximately 1,500 new launches in 2017.
對於 2016 年,在 Actavis Generics 的全年備考基礎上,我們看到 1,000 多個新產品發布增加到 2017 年的大約 1,500 個新產品發布。
Both Allergan and Teva are performing well since the announcement of the transaction in July of last year.
自去年 7 月宣布交易以來,Allergan 和 Teva 都表現良好。
The pipeline was estimated to be 320 ANDAs at the announcement in July; has grown to 326 ANDAs after taking into account divestiture of approximately 20 pipeline products.
在 7 月份的公告中估計管道中有 320 個 ANDA;考慮到約 20 種管道產品的剝離後,已增長到 326 個 ANDA。
The number of combined first-to-file has grown from 110 to 123.
在先申請的合併數量從 110 增加到 123。
And in the first quarter 2016 combined, the two companies had over 200 new product launches.
2016 年第一季度,兩家公司共推出了 200 多款新產品。
This alone has a tremendous impact on our future portfolio and product mix, as well as our long-term growth.
僅這一點就對我們未來的產品組合和產品組合以及我們的長期增長產生了巨大影響。
So what do we have to do to close the Actavis Generics transaction?
那麼我們必須做什麼才能結束 Actavis Generics 交易?
Well, as you know, we have received regulatory clearance in Europe and other international territories.
好吧,如您所知,我們已獲得歐洲和其他國際地區的監管許可。
We are close to finalizing the divestiture list with the FTC, and agreeing on the remedies.
我們即將與 FTC 敲定資產剝離清單,並就補救措施達成一致。
We have identified the buyers for a majority of the product, and remain on track for closing in June.
我們已經確定了大部分產品的買家,並有望在 6 月完成交易。
And rather than making you wait to the Q&A section, I'll reconfirm our commitment to achieve cost synergies and tax savings of approximately $1.4 billion annually, largely achievable by the third anniversary of the closing of the transaction.
我不會讓你等到問答部分,我會重申我們的承諾,即每年實現成本協同效應和節稅約 14 億美元,這在交易完成三週年之前基本可以實現。
This assumes approximately $1.1 billion of net global revenue divested, which, while higher than anticipated, as you can see has no impact on our commitment to delivering on our promise.
這假設剝離了大約 11 億美元的全球淨收入,雖然高於預期,但如您所見,這對我們兌現承諾的承諾沒有影響。
We have taken a significant step to transform our generic business, solidify our foundation, increase our profitability, and to better position us to generate sustainable long-term growth.
我們已經邁出了重要的一步來轉變我們的仿製藥業務,鞏固我們的基礎,提高我們的盈利能力,並使我們更好地實現可持續的長期增長。
These many steps have included portfolio optimization, strengthening our capabilities in R&D, and manufacturing of complex products, regaining a leading position in submission on first-to-files, enhancing our go-to-market, and sales force effectiveness capabilities, and much, much more.
這些許多步驟包括優化產品組合、加強我們在研發和製造複雜產品方面的能力、重新獲得在首次申請提交方面的領先地位、提高我們的上市和銷售團隊效率能力等等,多得多。
These are the very capabilities that companies must possess in order to thrive at the global level.
這些正是公司要在全球範圍內蓬勃發展所必須具備的能力。
We have created a unique and differentiated platform, positioned to extract significant value in the global growing generic space.
我們創建了一個獨特且差異化的平台,定位於在全球不斷增長的通用空間中獲取重要價值。
Now I turn the call over to Eyal.
現在我把電話轉給 Eyal。
Eyal Desheh - CFO
Eyal Desheh - CFO
Thank you very much, Siggi, and hello, everyone.
非常感謝 Siggi,大家好。
I'm pleased to review the financial section of the Q1 2016 results.
我很高興回顧 2016 年第一季度業績的財務部分。
As you can see from the highlights presented here, this was another strong quarter for Teva.
從這裡介紹的亮點可以看出,這是 Teva 的又一個強勁季度。
Sales declined by 3%, mostly due to exchange rates impact.
銷售額下降了 3%,主要是由於匯率的影響。
However, operating income, EBITDA, net income, and earning per share were at the same level of last year, due to improved efficiency, and profitability -- and Q1 last year was a very strong quarter as well.
然而,由於效率和盈利能力的提高,營業收入、EBITDA、淨收入和每股收益與去年持平——去年第一季度也是一個非常強勁的季度。
This is one a notable exception here.
這是一個值得注意的例外。
We'll continue to increase our investment in R&D, both in generics and specialty.
我們將繼續增加對仿製藥和特種藥物研發的投資。
Total R&D spend was $375 million for the quarter, 14% higher than last year.
本季度研發總支出為 3.75 億美元,比去年同期增長 14%。
So let's talk about exchange rates.
那麼讓我們來談談匯率。
Exchange rates had a negative influence of $107 million on revenues, but only $30 million on operating income, which was 2% up in real terms.
匯率對收入產生了 1.07 億美元的負面影響,但對營業收入的負面影響僅為 3000 萬美元,實際增長 2%。
We continued to generate a lot of cash this quarter, with cash flow from operation at $1.4 billion, and free cash flow at $1.2 billion.
本季度我們繼續產生大量現金,運營現金流為 14 億美元,自由現金流為 12 億美元。
Our total debt was $10 billion at the end of March, and financial [leverage] as well as debt to EBITDA ratio were down year over year, and we are well-positioned to raise the debt for the financing of the Allergan generic business.
截至 3 月底,我們的總債務為 100 億美元,財務 [槓桿] 以及債務與 EBITDA 的比率同比下降,我們有能力為 Allergan 仿製藥業務籌集債務。
And also we continued the trend of strong EBITDA at $1.6 billion to $1.7 billion per quarter.
此外,我們延續了每季度 16 億至 17 億美元的強勁 EBITDA 趨勢。
The sales decrease in the United States, as you can see from the geographical mix, was driven by the generic segment, mostly due to loss of exclusivity of esomeprazole and budesonide -- and Siggi referred to that before -- partially offset by increase in specialty medicine, mostly Copaxone and respiratory products.
正如您從地理組合中看到的那樣,美國的銷售額下降是由仿製藥部分推動的,主要是由於埃索美拉唑和布地奈德失去了獨占性——Siggi 之前提到過——部分被專科藥的增長所抵消醫藥,主要是Copaxone和呼吸道產品。
Net of FX, revenues were down by 1% as the loss of exclusivity of the US generic products was almost fully compensated by the strong performance of our specialty and OTC business, and the growth in our other generic businesses.
扣除外匯後,收入下降了 1%,因為美國仿製藥的排他性損失幾乎完全被我們專業和非處方藥業務的強勁表現以及我們其他仿製藥業務的增長所彌補。
Generic sales accounted for 45% of total sale, as a result of the loss of exclusivity in the US.
由於在美國失去獨占性,仿製藥銷售額佔總銷售額的 45%。
Copaxone sales were 21% of total, 1% higher than in full-year 2015.
Copaxone 銷售額佔總銷售額的 21%,比 2015 年全年高出 1%。
The specialty business without Copaxone was 24% of sales, an improvement, compared to the 2015 average, of 2%.
不含 Copaxone 的專業業務佔銷售額的 24%,與 2015 年的平均水平相比提高了 2%。
Global generics accounted for 32% of our operating profit.
全球仿製藥占我們營業利潤的 32%。
This compares with 37% in 2015 full year.
相比之下,2015 年全年這一比例為 37%。
The reason is loss of exclusivity, as we mentioned before, with few new launches this quarter.
正如我們之前提到的,原因是排他性的喪失,本季度幾乎沒有新產品推出。
Copaxone contributed 44% of total profit, compared to 42% for the whole year of 2015.
Copaxone 貢獻了總利潤的 44%,而 2015 年全年為 42%。
Speaking about Copaxone -- when we look at results quarter over quarter, total scripts were the same level as last year, with an increased proportion of 40-milligram, which contributes to our profit, where the small increase in units sold as well as the positive price effect leading to 9% sale growth mainly in the United States market.
談到 Copaxone——當我們逐季查看結果時,腳本總數與去年持平,增加了 40 毫克的比例,這有助於我們的利潤,其中銷售單位的小幅增長以及積極的價格效應導致主要在美國市場的銷售額增長 9%。
So this concludes the financial review, and now let's look at the dividend distribution.
財務回顧到此結束,現在讓我們來看看股息分配。
As you can see, our Board approved a dividend payment, in line with the $0.34 per share distributed in the 2015 quarters.
如您所見,我們的董事會批准了股息支付,與 2015 年季度派發的每股 0.34 美元一致。
Total payout increased, as a result of the equity offering last year, so we continued with the $0.34 per share dividend.
由於去年的股票發行,總派息增加,因此我們繼續派發每股 0.34 美元的股息。
So now let me take you through our guidance.
現在讓我帶您了解我們的指導。
Some background: pending the closing of the Actavis Generics acquisition, we are providing revenue and non-GAAP earnings per share guidance for the second quarter of 2016 only.
一些背景:在 Actavis Generics 收購完成之前,我們僅提供 2016 年第二季度的收入和非 GAAP 每股收益指引。
This includes the results of the Rimsa acquisition and the Teva-Takeda business venture, but not the Actavis Generics acquisition.
這包括 Rimsa 收購和 Teva-Takeda 商業投資的結果,但不包括 Actavis Generics 收購的結果。
We continue to work towards satisfying all conditions for the closing.
我們將繼續努力滿足關閉的所有條件。
And based on our estimate of the timing to obtain clearance from the US FTC, we currently expect to close in June 2016.
根據我們對獲得美國聯邦貿易委員會批准的時間的估計,我們目前預計將在 2016 年 6 月結束。
Assuming a June closing, and as you already heard from Erez, we expect to provide additional guidance as follows: full-year 2016 guidance including Actavis Generics during the Q2 2016 earnings call in August; and 2017, 2018 business and financial outlook in September 2016 after Labor Day.
假設 6 月結束,正如您已經從 Erez 那裡聽到的那樣,我們希望提供如下額外指導:2016 年全年指導,包括 Actavis Generics 在 8 月的 2016 年第二季度財報電話會議上;以及 2016 年 9 月勞動節後的 2017 年、2018 年業務和財務展望。
So our guidance for the second quarter here is $4.7 billion to $4.9 billion for revenues, and $1.16 to $1.20 for earning per share.
因此,我們對第二季度的指導是收入 47 億美元至 49 億美元,每股收益 1.16 美元至 1.20 美元。
Thank you all for listening to us this morning, and I would now like to open the call for questions.
感謝大家今天早上聽取我們的意見,現在我想開始提問。
Kevin Mannix - Head of IR
Kevin Mannix - Head of IR
Operator?
操作員?
Operator
Operator
(Operator Instructions)
(操作員說明)
Your first question comes from David Risinger.
你的第一個問題來自 David Risinger。
David Risinger - Analyst
David Risinger - Analyst
Thank you for all of the detailed prepared remarks, including Siggi's commentary on the pricing outlook.
感謝您準備好的所有詳細評論,包括 Siggi 對定價前景的評論。
I have a couple questions.
我有幾個問題。
First of all, I guess, first of all, Siggi, could you please comment on your expectations for longer term pricing?
首先,我想,首先,Siggi,您能否評論一下您對長期定價的期望?
Obviously, you just reiterated that you expect mid single-digit US price declines in 2016, but I was hoping that you could comment potentially longer term.
顯然,您剛剛重申您預計 2016 年美國價格將出現中等個位數的跌幅,但我希望您能就更長期的潛力發表評論。
And then second, you mentioned $1.1 billion in net global revenue to be divested, which is above expectations.
其次,您提到要剝離 11 億美元的全球淨收入,這超出了預期。
Could you discuss that, the impact of that on the expected accretion from the Allergan generics acquisition longer term?
你能否討論一下,這對艾爾建仿製藥收購的長期預期增長的影響?
Thank you very much.
非常感謝。
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
Yes, thanks, David.
是的,謝謝,大衛。
First of all, on long term pricing, it's difficult to comment on the long term pricing.
首先,關於長期定價,很難對長期定價發表評論。
But maybe we can think about, what are the factors that play into pricing.
但也許我們可以想一想,影響定價的因素有哪些。
So it's obviously, it has to do with competition in the market.
所以很明顯,這與市場競爭有關。
We know, if we look at the US market, there's 230 generic companies that are competing, so the competition is fierce.
我們知道,如果我們看看美國市場,有 230 家仿製藥公司在競爭,所以競爭非常激烈。
Secondly, its impacted by the new approvals by the FDA.
其次,它受到 FDA 新批准的影響。
The FDA has been approving more products, and it's impacted obviously by consolidation of the customers.
FDA 一直在批准更多產品,並且明顯受到客戶整合的影響。
I think overall, the consolidation of the customers hasn't changed that much in the last 24 months, as I said in my prepared remarks on, the change in the competition hasn't been that much.
我認為總體而言,在過去 24 個月中,客戶的整合併沒有太大變化,正如我在準備好的評論中所說的那樣,競爭的變化並沒有那麼大。
So at this point in time, I don't see foresee any big changes in the pricing environment in the US or globally.
所以在這個時間點,我認為美國或全球的定價環境不會發生任何重大變化。
There's nothing on the horizon that changes my mind.
地平線上沒有什麼能改變我的想法。
Over the last 10 years, I've been operating a US generic business now for 10 years in a row.
在過去的 10 年裡,我已經連續 10 年經營美國仿製藥業務。
The cycle has been from approximately minus 1% deflation, to maybe minus 7%.
這個週期是從大約負 1% 的通貨緊縮到負 7%。
It goes a little bit back and fourth.
它有點倒退和第四。
It's a cycle, it's a process, but we are approximately mid single-digit price erosion.
這是一個週期,這是一個過程,但我們的價格大約處於中等個位數的跌幅。
And there's nothing that we see now, that changes that, at least in the medium term, but very difficult to talk about the long term view on pricing.
我們現在沒有看到任何改變,至少在中期,但很難談論定價的長期觀點。
With regards to the $1.1 billion divestiture, you have to keep in mind, this is the global revenue impact.
關於 11 億美元的資產剝離,你必須記住,這是對全球收入的影響。
Where we were about expectations, just so we are clear, was in the UK.
我們很清楚,我們的期望是在英國。
We highlighted that, there was a larger divestiture in the UK than we expected so.
我們強調,英國的剝離規模比我們預期的要大。
But we highlighted also, we are committing fully to our net synergy number of $1.4 billion in cost and tax synergies as before.
但我們也強調,我們將一如既往地全力實現 14 億美元的成本和稅收協同淨協同效應。
So there is no impact on the accretion of the deal, due to the divestiture we are talking about.
因此,由於我們正在談論的剝離,對交易的增加沒有影響。
And on the timing of the synergies, is as before, we estimate that we get most of the synergies in the first 36 months after closing.
關於協同效應的時間,和以前一樣,我們估計我們在交易結束後的前 36 個月內獲得了大部分協同效應。
David Risinger - Analyst
David Risinger - Analyst
Thank you.
謝謝你。
Operator
Operator
(Operator Instructions)
(操作員說明)
Our next question comes from Tim Chiang.
我們的下一個問題來自 Tim Chiang。
Tim Chiang - Analyst
Tim Chiang - Analyst
Hi, thanks.
你好謝謝。
Siggi, there's certainly been a lot that's happened in the generic space over the last 9 to12 months, and certainly one thing that's happened is a resetting of valuations.
Siggi,在過去的 9 到 12 個月裡,通用領域肯定發生了很多事情,當然發生的一件事是估值的重置。
Now, I know that you guys announced this deal back in July of last year.
現在,我知道你們早在去年 7 月就宣布了這筆交易。
What can you comment about, in terms of the price you're putting on the table for Allergan?
就您為 Allergan 提出的價格而言,您有何評論?
You think that's still a fair price in today's environment?
你認為在今天的環境下這仍然是一個合理的價格嗎?
Erez Vigodman - CEO
Erez Vigodman - CEO
Hi, Tim.
嗨,蒂姆。
The answer is absolutely yes.
答案是肯定的。
The strategic value of the deal, is at least they[re one, that was when we announced the deal.
這筆交易的戰略價值,至少是他們[是一個,那是我們宣布交易的時候。
We have the opportunities in that US generic market, and in the global generic space are huge.
我們在美國仿製藥市場有機會,在全球仿製藥市場上也有巨大的機會。
And we strongly believe, that with everything that we are witnessing now, our opportunities for Teva are even bigger, compared to basically where when we announced the deal.
我們堅信,就我們現在所看到的一切而言,與我們宣布交易時的基本情況相比,我們對 Teva 的機會更大。
So for us, what we're creating in here, is a very unique platform, with the same at least the same strategic value that we alluded to when we announced the deal.
因此,對我們來說,我們在這裡創建的是一個非常獨特的平台,具有與我們宣布交易時提到的至少相同的戰略價值。
And at the end of the day, it is also about the economics.
歸根結底,它還與經濟學有關。
And from all of the messages that we are conveying in here, we strongly believe that we will be able to generate the economics that we promised.
從我們在這里傳達的所有信息來看,我們堅信我們將能夠實現我們承諾的經濟效益。
Operator
Operator
Your next question comes from Jami Rubin.
你的下一個問題來自 Jami Rubin。
Jami Rubin - Analyst
Jami Rubin - Analyst
Thank you.
謝謝你。
I just have a couple questions.
我有幾個問題。
Siggi, again I appreciated your explanation, but I think part of the confusion too, is that we're hearing about worsening generic drug price deflation, not just from other generic drug makers like Endo and Perigo, but also from some of the distributors.
Siggi,我再次感謝你的解釋,但我認為部分混淆是我們聽到仿製藥價格通縮惡化的消息,不僅來自其他仿製藥製造商,如 Endo 和 Perigo,還有一些分銷商。
And in fact, AmerisourceBergen said last week, that they were citing a worsening deflationary market, worse than they had expected, and they expected it to grow to high single-digits by the end of 2016, and stay there, in that range for the entire 2017.
事實上,AmerisourceBergen 上週表示,他們指出通貨緊縮市場正在惡化,比他們預期的還要糟糕,他們預計到 2016 年底它會增長到高個位數,並保持在這個範圍內整個 2017 年。
So if you could just explain the interrelationship between the manufacturers, the distributors?
那麼,您能否解釋一下製造商和分銷商之間的相互關係?
Why are the distributors citing something different, and citing something worse?
為什麼經銷商引用不同的東西,引用更糟糕的東西?
What needs to happen out there, for your guidance of sort of minus 4% or so, price deflation go to minus 6%, minus 7%, minus 8%?
那裡需要發生什麼,對於你的負 4% 左右的指導,價格通縮達到負 6%、負 7%、負 8%?
Give us some confidence that we are not going down this slippery slope?
給我們一些信心,我們不會走下這個滑坡?
And then Erez to you, clearly you are doubling down on a sector that has faced major headwinds, or clearly has been reset in terms of valuation.
然後埃雷茲對你來說,顯然你正在加倍投資一個面臨重大阻力的行業,或者顯然已經在估值方面進行了重置。
Can you remind us all, what is the investment thesis, what is the attractive investment thesis for being the largest generic drug company in the world?
您能否提醒我們所有人,投資主題是什麼,成為世界上最大的仿製藥公司的有吸引力的投資主題是什麼?
And then just lastly, you have cited your interest in continuing together do specialty pharma deals, once the Allergan deal is done.
最後,您表示有興趣在 Allergan 交易完成後繼續共同進行專業製藥交易。
But given where your valuation is, and given where your stock is sitting, and your confidence in the generic drug business, how do you balance the desire to do deals, with a significant stock buyback program that I think investors would really appreciate in this environment?
但考慮到你的估值,你的股票所處的位置,以及你對仿製藥業務的信心,你如何平衡交易的願望與我認為投資者在這種環境下會真正欣賞的重要股票回購計劃?
Thanks very much.
非常感謝。
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
So thanks, Jami on the -- this clearly is the hot topic, no question about it, and that's why I went in some details in my prepared remarks around the pricing.
所以,謝謝 Jami,這顯然是熱門話題,毫無疑問,這就是為什麼我在準備好的定價評論中詳細介紹了一些細節。
So first of all, I think what I laid out in my prepared remarks was, why we are saying the 4%.
因此,首先,我想我在準備好的發言稿中闡述的是,為什麼我們要說 4%。
It's basically due to our portfolio, because we are not operating -- we have approximately 375 products on the US market.
這基本上是由於我們的產品組合,因為我們沒有運營——我們在美國市場上有大約 375 種產品。
We have a good understanding.
我們有很好的了解。
We also walk away when the competition is too fierce on a product.
當產品競爭太激烈時,我們也會走開。
We are not trying to grow our market share, which affects the 4% market share.
我們並沒有試圖增加我們的市場份額,這影響了 4% 的市場份額。
I can't obviously comment on why ABC is seeing a high single-digit price erosion when we are talking about 4%.
當我們談論 4% 時,我無法明確評論為什麼 ABC 會看到高個位數的價格下跌。
But I would remind you both Cardinal and McKesson are seeing the similar numbers that we are quoting, that Mylan is talking about, and also what Allergan is talking about.
但我要提醒你,Cardinal 和 McKesson 都看到了我們引用的相似數字,Mylan 正在談論的,以及 Allergan 正在談論的。
So it's not all that bad.
所以這還不算太糟糕。
That's number one.
這是第一。
Number two, in terms of the -- not all companies are created equal, and one investor asked me is, are you the only good house, in a really bad neighborhood?
第二,就——並非所有公司生來都是平等的,一位投資者問我,你是唯一一家位於非常糟糕的社區的好房子嗎?
And I don't think that's it, because I think the other houses are blaming the neighborhood for their maintenance issues.
我不這麼認為,因為我認為其他房屋將維修問題歸咎於社區。
They are working with leaking houses, and it has to do with renewal of the portfolio, of lack of investment in generic R&D.
他們正在與洩漏的房屋合作,這與投資組合的更新有關,缺乏對仿製藥研發的投資。
That keeps you growing the business, because that is the key at the end of the day.
這會讓您的業務不斷發展,因為這是歸根結底的關鍵。
So I don't think you can look at companies, different companies, and say if company A is experiencing 7% price erosion, that should be the market norm.
所以我不認為你可以看看公司,不同的公司,然後說如果 A 公司正在經歷 7% 的價格侵蝕,那應該是市場常態。
You have to look at it differently for a company that has a big portfolio, strong new product launches, a differentiated portfolio, and a high quality portfolio.
對於擁有大量產品組合、強大的新產品發布、差異化產品組合和高質量產品組合的公司,您必須以不同的方式看待它。
Erez Vigodman - CEO
Erez Vigodman - CEO
Hi, Jami.
嗨,賈米。
Thank you for the questions, and I'll try to address all of them one by one.
感謝您提出的問題,我會盡力一一解答。
So first, in general, what we do in here, we build a diversified growth platform, a balanced portfolio of durable products that offers top line and bottom line gross profit.
因此,總的來說,首先,我們在這裡所做的是,我們建立了一個多元化的增長平台,一個平衡的耐用產品組合,提供了頂線和底線毛利潤。
And that's something which is important, in general to understand.
這一點很重要,通常需要理解。
And now, to address the additional questions, I think it's important to just put the context here, which is imperative.
現在,為了解決其他問題,我認為將上下文放在此處很重要,這是必不可少的。
Now, I believe that Teva has demonstrated an ability to allocate capital in a disciplined and strategic manner, and we'll continue to do that, to support our strategy first and foremost, which we believe ultimately will reward our shareholders.
現在,我相信 Teva 已經展示出以有紀律和戰略性的方式分配資本的能力,我們將繼續這樣做,首先支持我們的戰略,我們相信這最終會回報我們的股東。
We continue to see very attractive opportunities to grow our business through business development, and continue to explore them.
我們繼續看到非常有吸引力的機會來通過業務發展來發展我們的業務,並繼續探索它們。
Furthermore, the combined Company of Teva and Allergan generics will generate significant amounts of cash.
此外,Teva 和 Allergan 仿製藥合併後的公司將產生大量現金。
We mentioned numbers like $20 billion to $25 billion during the first three years following the closing.
我們在關閉後的前三年提到了 200 億至 250 億美元的數字。
Today we believe that the best use of our capital will be to rapidly de-lever in the coming years to 2 to 2.5 debt to EBITDA, as well as invest in the business development to secure additional growth opportunities, around the globe and in our different businesses.
今天,我們認為,我們資本的最佳用途將是在未來幾年內迅速將槓桿率降至 EBITDA 的 2 至 2.5 倍,並投資於業務發展以確保全球和我們不同地區的額外增長機會企業。
Of course, in any event, our Company is no stranger to share repurchases.
當然,無論如何,我們公司對股份回購併不陌生。
Over the years we have shown a willingness to employ them, in an effort to further reward shareholders.
多年來,我們表現出聘用他們的意願,以進一步回報股東。
We will continue to take a balanced approach to capital allocation.
我們將繼續採取平衡的方式進行資本配置。
And number three, we are -- the global generic industry is a $1 trillion industry, which is very profitable.
第三,我們是——全球仿製藥行業是一個價值 1 萬億美元的行業,利潤非常豐厚。
At the end of the day, when you look at it, very profitable industry, and there are not too many industries out there like the global generic space.
歸根結底,當你看它時,這是一個非常有利可圖的行業,而且像全球通用空間這樣的行業並不多。
We think, that when we look at the competitive -- the global competitive landscape, and what we are building here, it's a very, very unique set up.
我們認為,當我們審視競爭——全球競爭格局,以及我們在這裡構建的內容時,它是一個非常非常獨特的設置。
We believe that this global space possesses huge opportunities.
我們相信這個全球空間擁有巨大的機會。
And we believe that the challenges that folks face nowadays, just reinforce even further the opportunities for Teva, given the changes that we have been undergoing, and given the way we have been transforming the business, and given what we are building in there.
我們相信,鑑於我們一直在經歷的變化、我們轉變業務的方式以及我們正在建設的東西,人們如今面臨的挑戰只會進一步加強 Teva 的機遇。
So for us, the challenges around us, just even reinforces further the opportunities that we see.
所以對我們來說,我們周圍的挑戰甚至進一步加強了我們看到的機會。
And last but not least, we do not plan to use equity in acquisitions that we might entertain in the course of 2016.
最後但同樣重要的是,我們不打算在 2016 年可能進行的收購中使用股權。
So in any event, basically we said it and reiterated it, we plan to use the $3 billion to $5 billion capacity that we have modeled, in entertaining potential branded drug deals in the course of 2016.
所以無論如何,基本上我們說過並重申過,我們計劃利用我們模擬的 30 億至 50 億美元的產能,在 2016 年期間進行潛在的品牌藥物交易。
Jami Rubin - Analyst
Jami Rubin - Analyst
Thank you.
謝謝你。
Operator
Operator
Next question comes from Louise Chen.
下一個問題來自Louise Chen。
Louise Chen - Analyst
Louise Chen - Analyst
Hi, thanks for taking my questions.
您好,感謝您回答我的問題。
First question, I had here was on your CGRP program.
第一個問題,我這裡是關於你的 CGRP 計劃的。
I was wondering if you could give us an update on how enrollment for this trial is progressing, and when is the earliest we could see data here?
我想知道您是否可以向我們提供有關該試驗的註冊進展情況的最新信息,我們最早什麼時候可以在這裡看到數據?
And can you remind us also your $11.6 billion also -- I know this an older number on EBITDA in 2018 -- does that include CGRP or not?
你能否也提醒我們你的 116 億美元——我知道這是 2018 年 EBITDA 的舊數字——這是否包括 CGRP?
And second thing here, is just on your guidance, post close of generics deal.
第二件事,就是在你的指導下,仿製藥交易結束後。
Just curious, in the past you've talked about potential upside to your synergy guidance from sourcing?
只是好奇,過去您曾談到採購協同指導的潛在優勢?
Is that still on the table?
還在桌子上嗎?
Thanks.
謝謝。
Michael Hayden - Head of R&D and Chief Scientific Officer
Michael Hayden - Head of R&D and Chief Scientific Officer
Well, thank you, Louise, for that question on CGRP.
好吧,路易絲,謝謝你提出關於 CGRP 的問題。
I'm pleased to say that both the chronic and episodic migraine trials have begun.
我很高興地說,慢性和偶發性偏頭痛試驗都已經開始。
We primarily are recruiting in the US.
我們主要在美國招聘。
Recruitment is going exceedingly well, and of course, this talks to the tremendous need for novel therapies in this particular space.
招聘進展非常順利,當然,這也說明了這個特定領域對新療法的巨大需求。
We're looking forward to getting top line results by the end of 2017, with full exposure to results in 2018, and launching by early 2019, but we will keep obviously the Street informed.
我們期待在 2017 年底前獲得頂級業績,在 2018 年全面公佈業績,並在 2019 年初推出,但我們顯然會隨時通知華爾街。
We're delighted our recruitment is ahead of schedule, and we're making terrific progress associated with this.
我們很高興我們的招聘提前完成,並且我們在這方面取得了巨大的進展。
Also just to mention, and reiterate is, that we will be starting our trial in cluster headaches in the second half of this year, a very important unmet need, the suicidal headache for which CGRP may offer significant hope and benefit.
還要提一下並重申的是,我們將在今年下半年開始我們的叢集性頭痛試驗,這是一個非常重要的未滿足的需求,CGRP 可能為自殺性頭痛帶來巨大的希望和益處。
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
Maybe quickly on the synergies, as we said we reconfirmed, the $1.4 billion number, taking into account the new number, in terms of the divestiture of $1.1 billion.
也許很快就會產生協同效應,正如我們所說,我們再次確認了 14 億美元的數字,考慮到新的數字,就剝離 11 億美元而言。
We, that is our statement now, but we obviously will give a full guidance on the combined Company in August.
我們,這是我們現在的聲明,但我們顯然會在 8 月份對合併後的公司提供全面的指導。
Eyal Desheh - CFO
Eyal Desheh - CFO
And Louise, On your question about 2018 EBITDA and does it include CGRP, the answer is probably nothing, the product, even if launched sometimes in 2018, is not expected to generate any profit during the first year of launch.
路易絲,關於你關於 2018 年 EBITDA 的問題,它是否包括 CGRP,答案可能沒有,該產品即使有時在 2018 年推出,預計在推出的第一年也不會產生任何利潤。
Louise Chen - Analyst
Louise Chen - Analyst
Okay, thanks.
好的謝謝。
Operator
Operator
The next question comes from the line of Ronny Gal.
下一個問題來自 Ronny Gal 的台詞。
Ronny Gal - Analyst
Ronny Gal - Analyst
Hi, good morning, everybody, and thank you for taking the questions.
大家好,早上好,感謝您提出問題。
First, Siggi, would you help us understand the Paragraph IV launches during the year?
首先,Siggi,你能幫助我們了解年內推出的 Paragraph IV 嗎?
It seems you're now sitting at a point where you've got very few Paragraph IV revenue generating, or high margin products right now in your portfolio?
您現在似乎正處於這樣一個地步,即您的投資組合中幾乎沒有第 IV 段創收或高利潤產品?
Can you take us through how this will change during the year?
你能告訴我們這一年將如何變化嗎?
And you could also comment on your cost position for conversion cost overall, now that you are looking at your combined business with Actavis.
既然您正在考慮與 Actavis 的合併業務,您還可以評論整體轉換成本的成本狀況。
Where would you be in terms of cost structure?
就成本結構而言,您處於什麼位置?
And last, this is more for the branded side, the ProAir conversion to the second generation, it seems to be going a bit sluggishly.
最後,這更多是針對品牌方面,ProAir 轉換到第二代,似乎進展緩慢。
Can you help us at all think about this franchise going forward, how much you think we can keep Teva can keep at the time of generic entry, and is there any way you can accelerate this conversion?
您能否幫助我們考慮一下未來的特許經營權,您認為我們可以保留 Teva 在仿製藥進入時可以保留多少,您有什麼方法可以加速這種轉變?
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
So let me start, Ronny.
那麼讓我開始吧,羅尼。
So first of all, we have been very clear on that in the guidance for 2016.
所以首先,我們在 2016 年的指南中已經非常清楚地說明了這一點。
There's no, in the Teva portfolio, there's no significant Paragraph IV that we have pointed out.
沒有,在 Teva 產品組合中,我們沒有指出重要的第四段。
There are quite a few smaller launches that we have in 2016.
我們在 2016 年推出了很多小型產品。
None of those that we have been talking about in the public domain, but obviously for the combined Company the picture looks better for sure.
這些都不是我們在公共領域討論過的,但顯然對於合併後的公司來說,情況肯定會更好。
Just to highlight, and I'm not here to talk about the Actavis Generics business.
只是為了強調,我不是來談論 Actavis 仿製藥業務的。
I think they will have their results tomorrow.
我想他們明天就會有結果。
But to highlight for them, is in as far as last week, they have launched 30 new products in the US as of this year.
但值得強調的是,就在上週,截至今年,他們已經在美國推出了 30 種新產品。
So I think overall 2016 has a fewer Paragraph IV launches than before, Straightaway in 2017, we're going to show you that when we get together after closing of the deal, what to look for in the pipeline.
因此,我認為 2016 年總體上推出的第 IV 段比以前少,在 2017 年直截了當,我們將向您展示當我們在交易結束後聚在一起時,在管道中尋找什麼。
But I don't want to point out any Paragraph IVs in the Teva portfolio for the remainder of the year.
但我不想在今年剩餘時間內指出 Teva 投資組合中的任何第 IV 段。
These are relatively small launches that we are doing for the remainder of the year.
這些是我們在今年剩餘時間裡進行的相對較小的發布。
With regards to the conversion cost of the combined Company, that will be part of our guidance when we get together in August.
關於合併後公司的轉換成本,這將成為我們 8 月份開會時的指導意見的一部分。
We also don't think it's the right time to talk about the conversion cost guidance of a combined Company where we haven't closed the deal.
我們也不認為現在是討論我們尚未完成交易的合併公司的轉換成本指南的合適時機。
Rob Koremans - President and CEO, Global Specialty Medicines
Rob Koremans - President and CEO, Global Specialty Medicines
Yes, Ronny, with the conversion of ProAir to ProAir HFA, it's doing extremely well.
是的,Ronny,從 ProAir 到 ProAir HFA 的轉換,它做得非常好。
If I look at ProAir in terms of volume, it's more or less at 5% of the HFA.
如果我看 ProAir 的體積,它大約是 HFA 的 5%。
When it's in RespiClick, it's about 5% of the overall ProAir.
當它在 RespiClick 中時,它大約佔整個 ProAir 的 5%。
And the last part of it, really comes from new patients and if we compare to the conversions or the change to new inhalers also from Boehringer or GSK, we actually outperformed them.
最後一部分,實際上來自新患者,如果我們與勃林格或葛蘭素史克的新吸入器的轉換或改變進行比較,我們實際上優於他們。
But you're absolutely right, in terms of really moving the entire ProAir franchise towards the RespiClick, we need to further accelerate, and we are very committed to that.
但你是絕對正確的,就真正將整個 ProAir 特許經營權轉向 RespiClick 而言,我們需要進一步加速,我們非常致力於此。
Going forward, for the entire Respi franchise, we just launched Cinqair, the reslizumab, and we just also achieved very positive, as Erez said data on the FS RespiClick and FP RespiClick.
展望未來,對於整個 Respi 特許經營權,我們剛剛推出了 Cinqair,reslizumab,我們也取得了非常積極的成果,正如 Erez 在 FS RespiClick 和 FP RespiClick 上所說的那樣。
So we're strengthening the entire Respi Click franchise there.
因此,我們正在加強那裡的整個 Respi Click 特許經營權。
And having one and fairly unique advantage intuitive inhaler available for patients with multiple fixed combination products would be really an advantage.
為擁有多種固定組合產品的患者提供一個相當獨特的優勢直觀吸入器將是一個真正的優勢。
And we continue to drive that forward, and bring that forward.
我們將繼續推動這一進程,並將其推進。
And at the same time, defend our HFA as good as we can.
同時,盡我們所能捍衛我們的 HFA。
Ronny Gal - Analyst
Ronny Gal - Analyst
Thank you.
謝謝你。
Operator
Operator
The next question comes from the line of David Amsellem.
下一個問題來自 David Amsellem。
David Amsellem - Analyst
David Amsellem - Analyst
Thanks.
謝謝。
Joined late, so apologize if I missed this.
加入晚了,如果我錯過了這個,請道歉。
But on Bendeka, so assuming that there are generics on the lyophilized product, I guess, with the product not having a -J-Code, can you talk about how it's viable, if you do go to multi-source?
但在 Bendeka 上,假設凍乾產品上有仿製藥,我猜,如果產品沒有 -J-Code,你能談談它是如何可行的,如果你去多源?
And talk about your latest thoughts on, where your share would go in that kind of scenario, assuming that the case doesn't go your way?
並談談您的最新想法,假設案件沒有按照您的方式進行,您的份額在那種情況下會去哪裡?
Thanks.
謝謝。
Erez Vigodman - CEO
Erez Vigodman - CEO
Hi, David.
嗨,大衛。
I'll start, Rob or Michael can reinforce.
我會開始,Rob 或 Michael 可以增援。
So I think the next important milestone and the inflection point is, basically a decision on the ANDA case, so that's what we need to expect, and that's an inflection point and tipping point in the market.
所以我認為下一個重要的里程碑和拐點是,基本上是對 ANDA 案例的決定,所以這是我們需要期待的,這是市場的拐點和引爆點。
And I think all of us need to wait, and see what you basically got coming out in the course of the next few weeks.
而且我認為我們所有人都需要等待,看看在接下來的幾週內您基本上會得到什麼。
And just then, a comment on potential ramifications.
就在那時,對潛在後果的評論。
And Rob, would you would like to add something?
Rob,你想補充點什麼嗎?
Rob Koremans - President and CEO, Global Specialty Medicines
Rob Koremans - President and CEO, Global Specialty Medicines
Yes, Erez, I think you're fully right.
是的,Erez,我認為你完全正確。
And then also on the J-codes, there's a preliminary decision by the CMS.
然後還有關於 J 代碼,CMS 做出了初步決定。
Eagle, with our support, definitely we'll try and fight that and try to address it in a public hearing, later this month, and the final decision is out in November of this year.
Eagle,在我們的支持下,我們肯定會努力解決這個問題,並在本月晚些時候的公開聽證會上解決這個問題,最終決定將在今年 11 月公佈。
So even if the initial decision wasn't positive, the fight on the J-code itself is also not over.
因此,即使最初的決定不是肯定的,關於 J 代碼本身的鬥爭也沒有結束。
Clearly, if --and I think we need to really wait for these results.
顯然,如果——而且我認為我們真的需要等待這些結果。
If the J-code would not come, there would be generics for the lyophilized products, then we really are facing a difficult situation, where we believe that Bendeka will become a relatively small product going forward, but we still have many options to try and intervene and present it.
如果 J-code 不來,凍乾產品就會有仿製藥,那麼我們真的面臨一個困難的局面,我們相信 Bendeka 將成為一個相對較小的產品,但我們仍然有很多選擇可以嘗試和介入並呈現它。
David Amsellem - Analyst
David Amsellem - Analyst
Thank you.
謝謝你。
Operator
Operator
The next question comes from the line of Ken Cacciatore.
下一個問題來自 Ken Cacciatore。
Ken Cacciatore - Analyst
Ken Cacciatore - Analyst
Hi, good morning.
早上好。
Just wondering on that $1.1 billion of revenue, just could you give us a sense maybe in advance of the value that you're going to be capturing as you assign that?
只是想知道這 11 億美元的收入,您能否提前讓我們了解一下您在分配時將獲得的價值?
And then, maybe discuss how that value may have some impact on your ability to, either increase the size of your business development that you're looking at?
然後,也許可以討論該價值如何對您的能力產生一些影響,或者增加您正在尋找的業務發展規模?
And then in terms of business development, can you talk about the environment asset values have come down to a certain extent?
然後在業務發展方面,您能談談環境資產價值有一定程度的回落嗎?
But can you discuss maybe the other side of the fence, the folks you may be negotiating with, their reason ability in terms of where valuations are now?
但是你能不能討論圍欄的另一邊,你可能正在與之談判的人,他們在估值方面的理性能力?
Thank you.
謝謝你。
Erez Vigodman - CEO
Erez Vigodman - CEO
Hi Ken.
嗨,肯。
First, I think that's an opportunity again, just to underscore the implication of 1.1b (in divestitures) is basically embedded into the $1.4 billion of net synergies.
首先,我認為這又是一個機會,只是為了強調 1.1b(資產剝離)的含義基本上嵌入到 14 億美元的淨協同效應中。
That's something I think that message is in a very important message.
我認為這是一條非常重要的信息。
And so, when we say that we are committed to generate $1.4 billion of net synergies, it means that it includes the higher divestitures, versus initial expectations.
因此,當我們說我們致力於產生 14 億美元的淨協同效應時,這意味著它包括比最初預期更高的資產剝離。
And that's basically a clear important message that we are conveying here.
這基本上是我們在這里傳達的一個明確的重要信息。
So that's number one.
所以這是第一。
Number two, yes, we will get higher value.
第二,是的,我們將獲得更高的價值。
It might increase the optionality on potential BD deals during 2016, but we prefer to discuss details when we close the deal.
它可能會增加 2016 年潛在 BD 交易的可選性,但我們更願意在完成交易時討論細節。
Operator
Operator
Next question comes from the line of Chris Schott.
下一個問題來自 Chris Schott。
Chris Schott - Analyst
Chris Schott - Analyst
Great.
偉大的。
Thanks very much for the questions.
非常感謝您的提問。
Just heading back to the competitive landscape on the generics side, it clearly seems like some of your competitors are having some challenges here.
回到仿製藥方面的競爭格局,顯然您的一些競爭對手似乎在這方面遇到了一些挑戰。
I guess, just two part question here.
我想,這裡只有兩部分問題。
A, what do you see happening to these smaller players, given these challenging market dynamics?
A,鑑於這些具有挑戰性的市場動態,您認為這些較小的參與者會發生什麼?
And B, are you concerned that these companies become increasingly less rational competitors as they try to defend their business, and that could have spillover effect into Teva's business?
B,你是否擔心這些公司在試圖捍衛自己的業務時變得越來越不理性,這可能會對 Teva 的業務產生溢出效應?
The second question I had is on that $1.1 billion divestiture, what was expectation?
我的第二個問題是關於 11 億美元的資產剝離,預期是什麼?
So how much more are you offsetting with the synergies in the business, to keep that net number the same?
那麼,為了保持淨值不變,您還要抵消業務中的協同效應多少?
And then, finally on generic gross margins, some very healthy trends year-over-year.
然後,最後在通用毛利率方面,一些非常健康的同比趨勢。
How much more opportunity is there to improve margins on the current standalone business, as we think about the next year or so before, Allergan gets into the mix?
有多少機會可以提高當前獨立業務的利潤率,正如我們考慮的那樣,在明年左右之前,Allergan 將加入其中?
Thanks so much.
非常感謝。
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
Thanks, Chris.
謝謝,克里斯。
First of all, on the competitive environment, and on that you're right.
首先,關於競爭環境,你是對的。
The smaller companies are probably having a tougher time.
規模較小的公司可能處境艱難。
And it goes back to what I mentioned as the first reason on why they're seeing a tougher price erosion is.
這可以追溯到我提到的第一個原因,即為什麼他們看到更嚴重的價格侵蝕。
There was, It think, a market where it was good for the business to be in a niche environment, where you had one or two products, where you could take price increases and thus allowed your overall market to grow.
它認為,在一個市場上,企業處於利基環境中是有好處的,在那裡你有一種或兩種產品,在那裡你可以提價,從而讓你的整體市場增長。
I think in the current environment, maybe there isn't the same opportunity for that.
我認為在當前環境下,也許沒有同樣的機會。
You basically benefit from having a much larger portfolio, where some of the portfolio is clearly under threat, but other parts of the portfolio you can grow with new product launches.
你基本上受益於擁有更大的產品組合,其中一些產品組合顯然受到威脅,但產品組合的其他部分可以隨著新產品的發布而增長。
Am I concerned that they might take up irrational behavior?
我擔心他們可能會採取非理性行為嗎?
I don't know.
我不知道。
I have said to you Chris, many times before, we are only as good as our most stupid competitor in the market.
克里斯,我之前曾多次對你說過,我們只能和市場上最愚蠢的競爭對手一樣好。
So we have to see.
所以我們必須看到。
But so far, I think there's no sign of that in the market per se.
但到目前為止,我認為市場本身還沒有這種跡象。
What was the original number?
原來的號碼是多少?
I'm not going to go down to that, because we never gave that in our guidance.
我不會深入到那個,因為我們從來沒有在我們的指導中給出。
But as I highlighted around the $1.1 billion.
但正如我強調的那樣,大約是 11 億美元。
Where we ended up with a higher divestiture, was around the UK.
我們最終獲得更高資產剝離的地方是在英國各地。
We basically we have to divest as it's in the public domain from the European Commission.
我們基本上必須從歐盟委員會剝離,因為它屬於公共領域。
We have to divest more than 50% of the Actavis UK business, and we haven't assumed that.
我們必須剝離超過 50% 的 Actavis UK 業務,而我們還沒有做出這樣的假設。
But that is the key difference in the divestiture.
但這是資產剝離的關鍵區別。
But also we have to keep in mind, that it is approximately $1.1 billion we are talking about because we haven't had the sign off -- the final sign off from the FTC.
但我們也必須記住,我們正在談論的大約是 11 億美元,因為我們還沒有簽署——聯邦貿易委員會的最終簽署。
So it's not right at this point in time, to talk about the final number.
所以現在談論最終數字是不合適的。
But although, we feel that we have agreed to the products that need to be divested.
但是雖然,我們覺得我們已經同意了需要剝離的產品。
With regards to how we would look standalone, and that's a little bit like a fairy tale.
關於我們看起來如何獨立,這有點像童話故事。
I said that when we talked about last year, where we were at last year, that I thought we could do about 200 basis points more, if we would be a standalone.
我說過,當我們談到去年,我們去年的情況時,我認為如果我們是獨立的,我們可以多做大約 200 個基點。
I think we still can do that.
我認為我們仍然可以做到這一點。
We went half way in this quarter.
我們在這個季度走了一半。
There's still an opportunity.
還有機會。
I'm optimistic about the business.
我對這項業務持樂觀態度。
We are really running a good business, even in the US business where we experience that year-over-year comparison is difficult, due to the exclusivity of esomeprazole a year ago, really the underlying business is doing well.
我們確實經營著一家很好的企業,即使是在我們經歷過同比比較困難的美國企業,由於一年前埃索美拉唑的排他性,基礎業務確實做得很好。
And I have to say, that our European business is performing better than ever before.
我不得不說,我們的歐洲業務表現比以往任何時候都好。
So I'm optimistic, but there is a limit how much you can improve the operating profit of a business.
所以我很樂觀,但你能提高一家企業的營業利潤是有限度的。
And I stand by my previous statement of around 200 basis points from last year.
我堅持我之前關於去年降息 200 個基點的說法。
Operator
Operator
The next question comes from the line of Gregg Gilbert.
下一個問題來自 Gregg Gilbert。
Gregg Gilbert - Analyst
Gregg Gilbert - Analyst
Yes, hi, good morning and good afternoon.
是的,嗨,早上好,下午好。
Sorry if you covered this, I don't think you did.
對不起,如果你涵蓋了這個,我認為你沒有。
But is the EBITDA contribution from Allergan in 2016, the same that you already projected, other than the change in the closing timing?
但是除了關閉時間的變化之外,Allergan 在 2016 年的 EBITDA 貢獻是否與您已經預測的相同?
And Siggi, what type of info are you getting from Allergan, and how frequently do you get it?
Siggi,你從 Allergan 獲得什麼類型的信息,你多久獲得一次?
And then my follow-up is on 809?
然後我的跟進是在809上?
Perhaps you could talk about commercial readiness, and how your interactions with the FDA are going so far?
也許你可以談談商業準備,以及你與 FDA 的互動到目前為止進展如何?
Thanks.
謝謝。
Eyal Desheh - CFO
Eyal Desheh - CFO
So maybe I'll start with the EBITDA coming from the Allergan generic piece.
所以也許我會從來自 Allergan 仿製藥的 EBITDA 開始。
They're moving pieces, we, in the original model, we assume the full year.
他們正在移動,我們在原始模型中假設全年。
Now it is becoming a half a year.
現在變成半年了。
Of course, the synergies are not linear, in six months, you can achieve less.
當然,協同效應不是線性的,在六個月內,你可以實現更少。
But as you heard from Siggi, our three years from closing target, remains very well on target, and in place.
但正如你從 Siggi 那裡聽到的那樣,我們距離完成目標的三年時間仍然很好地實現了目標。
So proportionately, it could be a little less, but keep in mind, it is a six-month period, and not a full year period.
所以按比例,它可能會少一點,但請記住,這是六個月的時間,而不是一整年的時間。
So look at 2016 as a transition year, and the real year to measure will be 2017.
因此,將2016年視為過渡年,真正衡量的年份將是2017年。
And that's why we will provide some outlook earlier than what we normally do.
這就是為什麼我們會比平時更早地提供一些展望。
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
On the, Gregg, around the information we get from Allergan.
格雷格,關於我們從艾爾建獲得的信息。
First of all, we have -- we are competitors in the market.
首先,我們有——我們是市場上的競爭對手。
We have to be very careful.
我們必須非常小心。
We cannot exchange any information.
我們不能交換任何信息。
We are competing very forcefully in the market until closing.
在交易結束之前,我們在市場上競爭非常激烈。
So for example, we have no access to financial information that we have in the quarter, that they haven't reported.
因此,例如,我們無法訪問我們在該季度擁有的財務信息,他們尚未報告。
But the information that we have is what's in the public domain.
但我們擁有的信息屬於公共領域。
So we know how many first-to-files they have had.
所以我們知道他們有多少先到文件。
We know what number of launches they're doing in the market, because we are competing with them in the market.
我們知道他們在市場上推出了多少產品,因為我們在市場上與他們競爭。
And with all of the indicators that we are seeing, and most of them -- all of them are in the public domain, they are running a very good business.
根據我們看到的所有指標,其中大部分——所有指標都在公共領域,它們的業務非常好。
With regards to the integration, we're doing well.
關於整合,我們做得很好。
We have announced the first four layers of the organization, obviously pending closing of the deal.
我們已經宣布了該組織的前四層,顯然是在等待交易完成。
And all, we have 31 integration team in place, which are now prepared to launch for day one.
而且,我們有 31 個集成團隊,現在準備在第一天啟動。
So we are ready, whenever we get the final approval from the Federal Trade Commission, and we can close this transaction.
所以我們準備好了,只要我們得到聯邦貿易委員會的最終批准,我們就可以結束這筆交易。
Michael Hayden - Head of R&D and Chief Scientific Officer
Michael Hayden - Head of R&D and Chief Scientific Officer
Thanks, Gregg, on the question of the SD-809, the NDA is under active review, and we are working very closely with the agency to address the final questions that have arisen during the review process.
謝謝 Gregg,關於 SD-809 的問題,NDA 正在積極審查中,我們正在與該機構密切合作,以解決審查過程中出現的最終問題。
I must say, there's tremendous enthusiasm in the community, the Huntington community about this particular product.
我必須說,社區,亨廷頓社區對這個特殊產品有著極大的熱情。
Of course, there's been only one product ever approved for Huntington disease in the United States in 2008.
當然,2008 年美國祇有一種產品被批准用於治療亨廷頓病。
And this product has improved efficacy and in particular an improved safety profile.
該產品提高了療效,尤其是提高了安全性。
And Rob, if you just wanted to talk about the preparations for launch?
Rob,如果你只是想談談發射的準備工作?
Rob Koremans - President and CEO, Global Specialty Medicines
Rob Koremans - President and CEO, Global Specialty Medicines
Yes, Gregg, Michael, with pleasure.
是的,格雷格,邁克爾,很高興。
The commercial, is in great shape.
廣告,是在偉大的形狀。
We're taking a very patience and also caregiver type of approach, where this is really, really important.
我們正在採取非常耐心和照顧者類型的方法,這非常非常重要。
Like Michael said the excitement is big, not only in the Huntington's community.
就像邁克爾說的那樣,興奮是巨大的,不僅在亨廷頓社區。
But also for us internally having the opportunity to bring a real meaningful improvement to people that so badly need it, is really exciting.
但對我們內部來說,也有機會為急需它的人們帶來真正有意義的改進,這真的很令人興奮。
And in terms of medical, commercial and also payer preparation, everything is in place, and we are ready to do this, and bring these products to patients, as soon as the FDA would approve it.
在醫療、商業和付款人準備方面,一切都已到位,我們準備好這樣做,並在 FDA 批准後儘快將這些產品帶給患者。
Operator
Operator
The next question comes from the line of Liav Abraham.
下一個問題來自 Liav Abraham。
Liav Abraham - Analyst
Liav Abraham - Analyst
Good morning.
早上好。
Siggi, you spoke about 10% volume growth from the combined product pipeline over the next few years.
Siggi,你談到未來幾年合併產品線的銷量增長 10%。
What visibility do you have for this growth, and what makes you confident that you can maintain this volume growth over a period of time, beyond the next couple of years?
您對這種增長有什麼可見性,是什麼讓您有信心在未來幾年之後的一段時間內保持這種銷量增長?
And then, secondly, can you comment on the increased pace of ANDA approvals by the FDA?
然後,其次,你能評論一下 FDA 加快批准 ANDA 的速度嗎?
One could argue that this will increased the competitive environment for generic companies including the combined Teva Allergan generic business?
有人可能會爭辯說,這將增加仿製藥公司的競爭環境,包括合併後的 Teva Allergan 仿製藥業務?
I'd be interested on your thoughts on these dynamics, and the potential net impact on Teva, if any?
我想知道您對這些動態的看法,以及對 Teva 的潛在淨影響(如果有的話)?
Thank you.
謝謝你。
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
Yes, thanks, Liav.
是的,謝謝,利亞夫。
So in terms of the formula, I talked about the 10% growth, we're talking about obviously value growth, revenue and profit growth.
所以就公式而言,我談到了 10% 的增長,我們談論的顯然是價值增長、收入和利潤增長。
It doesn't mean necessarily this is the volume growth, because usually the new product launches have a smaller volume, than the old portfolio so.
這並不一定意味著銷量增長,因為新產品發布的銷量通常比舊產品組合小。
But we have amazing network, obviously we have in the combined network, we have plenty of capacity for complex generics that we will be introducing.
但是我們有驚人的網絡,顯然我們在聯合網絡中,我們有足夠的能力來處理我們將要引入的複雜仿製藥。
But overall, we are very confident with our current network we still have plenty of opportunity to grow going forward.
但總的來說,我們對我們目前的網絡非常有信心,我們仍然有很多機會向前發展。
In terms, of how long we can maintain this, I feel we have it for the long run.
就我們能維持多久而言,我覺得我們可以長期維持下去。
What I know now is, what is pending at the FDA in the combined pipeline of Actavis Generics and Teva, from what I see, I'm very confident over the next two to three years, because of what has already been filed.
我現在所知道的是,在 Actavis Generics 和 Teva 的聯合管道中,FDA 正在等待什麼,據我所知,我對未來兩到三年非常有信心,因為已經提交了文件。
So that gives me -- that's the beauty of the generic business, the risk around approval is much less than otherwise.
所以這給了我——這就是通用業務的美妙之處,批准的風險比其他方式要小得多。
And the second reason is why I think it's long term is, that our current commitment to further invest in the generic R&D as I mentioned before, yes, we are not going to invest $850 million, which is the combined generic R&D budget, but it will be very significant investment we want to do.
第二個原因是為什麼我認為這是長期的,正如我之前提到的,我們目前承諾進一步投資仿製藥研發,是的,我們不會投資 8.5 億美元,這是仿製藥研發的總預算,但它將是我們想要做的非常重要的投資。
And also to be enablers to maintain the growth we are talking about.
並成為維持我們正在談論的增長的推動者。
With regards to the increased pace of the FDA of approval you're right.
關於 FDA 批准速度的加快,你是對的。
They are picking up the pace.
他們正在加快步伐。
And I think partly that has to do that they want to meet the GDUFA statistical guidelines where they need to be, because we have already started to negotiate GDUFA 2. But also you have to keep in mind, that for every approval that generics get, we get approximately two complete response letters.
我認為部分原因是他們希望在需要的地方滿足 GDUFA 統計指南,因為我們已經開始談判 GDUFA 2。但你也必須記住,對於仿製藥獲得的每一次批准,我們收到大約兩封完整的回复信。
So yes, there is a lot of movement.
所以是的,有很多動作。
They are having a targeted action day but the ratio is currently for one approval, there's two complete response letters.
他們有一個有針對性的行動日,但目前的比率是一次批准,有兩封完整的回复信。
The good thing is the FDA is that the moving forward.
好事是 FDA 正在向前發展。
But when you think about it, the combined portfolio of 300 and nearly 30 ANDAs, is that if the FDA starts to accelerate for the whole industry, the combined company of Actavis Generics and Teva will have approximately 10% of all ANDA pending at the close of this transaction.
但仔細想想,300 個和近 30 個 ANDA 的組合組合,如果 FDA 開始加速整個行業,Actavis Generics 和 Teva 的合併公司在收盤時將有大約 10% 的 ANDA 待定本次交易。
And we will also benefit from the acceleration, so it's not only [net additive] on the pricing.
而且我們也將從加速中受益,所以它不僅是定價的[淨附加]。
I think this is net-net positive for the combined Company going forward, so I'm excited about it.
我認為這對合併後的公司來說是積極的,所以我很興奮。
I only see that as a good thing, if the FDA accelerates approval of generics.
如果 FDA 加快對仿製藥的批准,我只認為這是一件好事。
Liav Abraham - Analyst
Liav Abraham - Analyst
Okay.
好的。
Thank you.
謝謝你。
Operator
Operator
The next question comes from the line of Elliot Wilbur.
下一個問題來自 Elliot Wilbur 的台詞。
Elliot Wilbur - Analyst
Elliot Wilbur - Analyst
Thank you, good morning.
謝謝你,早上好。
I also wanted to touch on the subject of pricing, but actually my question is directed at Rob, with respect to the specialty business.
我還想談談定價問題,但實際上我的問題是針對專業業務的 Rob。
Specifically, in the press release you talk about Copaxone having a net positive impact in terms of year-over-year growth, driven by positive pricing dynamic?
具體來說,在新聞稿中,您談到在積極定價動態的推動下,Copaxone 對同比增長產生了淨積極影響?
And I'm just curious how you're seeing that play out, or how you expect that to play out over the balance of the year?
我只是很好奇你是如何看待這種情況的,或者你希望它如何在今年餘下的時間裡發揮作用?
Obviously, it seems like there's a lot of payer pressure on specialty products.
顯然,專業產品似乎承受著很大的付款壓力。
And I think the expectation was that the pricing dynamics would be neutral to negative for Copaxone, but obviously not the case in the first quarter?
而且我認為預期是 Copaxone 的定價動態將是中性甚至負面的,但顯然第一季度的情況並非如此?
Then maybe extend that question to some of the rest of the specialty portfolio, specifically in the US, maybe just generally comment on price volume dynamics there?
然後也許將這個問題擴展到其他一些專業投資組合,特別是在美國,也許只是一般評論那裡的價格量動態?
And then a follow-up question for Eyal.
然後是 Eyal 的後續問題。
Given the expected immediacy of the close of the Allergan generics business, can you maybe talk to us a little bit about your expectations around the debt side of the balance sheet, in terms of the current bridge loan?
鑑於艾爾建(Allergan)仿製藥業務關閉的預期即時性,您能否就當前的過橋貸款與我們談談您對資產負債表債務方面的預期?
How much of that needs to be refinanced and what you think about in terms of the terms structure there, and the associated interest rate with the final debt package?
其中有多少需要再融資,您對那裡的條款結構以及最終債務方案的相關利率有何看法?
Rob Koremans - President and CEO, Global Specialty Medicines
Rob Koremans - President and CEO, Global Specialty Medicines
First, the Copaxone is really doing well, and like you said, we see a lot of the impacts also from the net price increase of 7.9% that we -- that were on both strengths in the beginning of the year.
首先,Copaxone 確實做得很好,就像你說的那樣,我們也看到了 7.9% 的淨價增長帶來的很多影響,我們在年初的兩個優勢上都有所體現。
But it's actually really a result of fantastic underlying demand.
但這實際上是極好的潛在需求的結果。
The products is keeping well, it's the number one product in new patients now, and Copaxone is really, actually a very good alternative and patients have access to it, right?
這些產品一直保持良好狀態,它現在是新患者中排名第一的產品,而 Copaxone 確實是一個非常好的替代品,患者可以使用它,對吧?
So in no way has the price been a limitation in that sense.
因此,從這個意義上說,價格絕不是限制。
And I think that's the key going forward, is you'll always have to be able to demonstrate value to stakeholders, to patients, to payers and overall for your products in whatever we offer.
我認為這是前進的關鍵,無論我們提供什麼,您都必須始終能夠向利益相關者、患者、付款人以及您的產品整體展示價值。
It's really important to be able to show the value of what you're doing.
能夠展示您正在做的事情的價值非常重要。
And it's not just about the price, but it's really incredibly important thing to just talk about the value you're offering.
這不僅僅是關於價格,而是談論你提供的價值真的非常重要。
And clearly for Copaxone, we're having the right mix.
很明顯,對於 Copaxone,我們的組合是正確的。
The product is much appreciated, unparalleled in its track record of both efficacy and safety, and available to just about 96% of lives in the US.
該產品廣受讚賞,其有效性和安全性的記錄無與倫比,並且僅適用於美國約 96% 的人。
So pricing there, I see extremely good.
所以在那裡定價,我認為非常好。
Going forward, I think I just answered that.
展望未來,我想我剛剛回答了這個問題。
You cannot just look at price.
不能只看價格。
You have to look at the value you're bringing to patients and the system.
你必須看看你給病人和系統帶來的價值。
And for all of our products we're very much aware of this, and this is exactly the approach we're following at Teva.
對於我們所有的產品,我們都非常清楚這一點,這正是我們在 Teva 所遵循的方法。
Eyal Desheh - CFO
Eyal Desheh - CFO
Okay, and on the final plan, it remains by and large the same, maybe improved a little.
好的,在最終計劃上,它大體上保持不變,也許會有所改進。
We continue to accumulate cash during first half of 2016, so we'll probably not need an entire $[27] billion of bridge loan which is available to us.
我們在 2016 年上半年繼續積累現金,因此我們可能不需要提供給我們的全部 [27] 億美元的過橋貸款。
The plan is to close on the bridge, and go to the market at September time frame or in Q4.
計劃是在橋上收盤,並在 9 月或第 4 季度上市。
We see a very good market environment, and rates remained very favorably low, a bit lower than what we had in our original expectations, and hopefully we'll stay that way.
我們看到一個非常好的市場環境,利率仍然非常低,略低於我們最初的預期,希望我們能保持這種狀態。
And the bridge is just to remind everyone from two years from drawdown, so we have a lot of flexibility on selecting the time of go-to-market.
而且這個bridge只是提醒大家從回撤兩年開始,所以我們在選擇上市時間上有很大的靈活性。
Operator
Operator
The next question comes from the line of Umer Raffat.
下一個問題來自 Umer Rafat。
Umer Raffat - Analyst
Umer Raffat - Analyst
Hi, thanks for taking my question, excuse me.
嗨,謝謝你接受我的問題,不好意思。
Erez, maybe one for you, how do you intend to approach SD-809 pricing, considering your initial approval being Huntington's, but the bigger population will be tardive dyskinesia where your competitor might come in materially lower than Pridopidine pricing?
Erez,也許一個適合你,你打算如何接近 SD-809 定價,考慮到你最初的批准是亨廷頓舞蹈病,但更大的人群將是遲發性運動障礙,你的競爭對手可能會比普利多匹定定價低得多?
And Michael just wanted to clarify two things with you.
邁克爾只是想和你澄清兩件事。
First you said CGRP Phase 3 timing is late 2017, and I suspect that might put you 6 or 12 months behind competition?
首先,您說 CGRP 第 3 階段的時間是 2017 年底,我懷疑這可能會使您落後於競爭對手 6 或 12 個月?
I just wanted to make sure I clarified that?
我只是想確保我澄清了這一點?
And other thing you said was, on SD-809, Michael you said FDA had raised some final questions in the review process.
你說的另一件事是,關於 SD-809,Michael 你說 FDA 在審查過程中提出了一些最後的問題。
So I wanted to confirm, are we still on track for late May PDUFA?
所以我想確認一下,我們是否仍按計劃在 5 月下旬推出 PDUFA?
And finally for Siggi, Siggi just wanted to ask what's your updated EBITDA number for Allergan generics standalone in 2017, given the divestitures?
最後對於 Siggi,Siggi 只是想問一下,考慮到資產剝離,您在 2017 年更新的獨立艾爾建仿製藥的 EBITDA 數字是多少?
Thank you.
謝謝你。
Michael Hayden - Head of R&D and Chief Scientific Officer
Michael Hayden - Head of R&D and Chief Scientific Officer
Okay.
好的。
Thank you, Umer.
謝謝你,烏默爾。
Just to answer on CGRP.
只是為了回答 CGRP。
Of course, at the present time yes, we've always calculated for chronic migraine that we would be in all likelihood, first-to-market for episodic second.
當然,目前是的,我們一直在計算慢性偏頭痛,我們很可能首先進入市場,然後再進入市場。
But I would say that we're making great progress, and we'll have to see how these trials run out.
但我會說我們正在取得很大進展,我們將不得不看看這些試驗如何結束。
The -- it's all about the timing of the recruitment, and also the strength of the results.
- 這完全取決於招聘的時間,以及結果的強度。
But we believe that this particular product is --has a differentiated profile thus far, and is being -- the recruitment is ahead of schedule.
但我們相信,這個特定的產品 - 到目前為止具有差異化的形象,並且正在 - 招聘提前完成。
So at the moment, we are talking about the end of 2017.
所以目前,我們正在談論 2017 年底。
But again, as the recruitment continues, we'll be able to update that during the course of the trial, and to be able to give you the latest information on that.
但同樣,隨著招聘的繼續,我們將能夠在試驗過程中對其進行更新,並能夠為您提供最新的信息。
With regard to the FDA, at this point, we don't really comment, and we do not want to comment on active discussions with the FDA at this time.
關於 FDA,在這一點上,我們並沒有真正發表評論,我們也不想就目前與 FDA 的積極討論發表評論。
We're excited about SD-809, and certainly we will keep everyone informed of any actions when the review is complete.
我們對 SD-809 感到興奮,當然我們會在審查完成後讓每個人了解任何行動。
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
And maybe Umer, of course, I can't update on the guidance on EBITDA for 2017.
也許 Umer,當然,我無法更新 2017 年 EBITDA 的指導。
We are going to come out in September, as you heard from both Erez and Eyal in terms of guidance.
正如您從 Erez 和 Eyal 那裡聽到的那樣,我們將在 9 月推出。
The only thing I want to say is, obviously with a six-month delay or five month delay in closing, we are still committing to the synergies of $1.4 billion within the first 36 months, majority of them within the first 36 months.
我唯一想說的是,顯然延遲六個月或延遲五個月關閉,我們仍然承諾在前 36 個月內實現 14 億美元的協同效應,其中大部分在前 36 個月內。
So they are moving out.
所以他們要搬出去。
Clearly in 2016, you don't get the same synergies as you would have been getting if you get, for 12 months the same year.
很明顯,在 2016 年,在同年的 12 個月裡,你沒有得到與你本來會得到的相同的協同效應。
The synergies are not linear.
協同作用不是線性的。
S we need to look at it, when we get the business, when we close the transaction to give you an accurate number, what we see the EBITDA for 2017.
S 我們需要看看它,當我們獲得業務時,當我們關閉交易時給你一個準確的數字,我們看到 2017 年的 EBITDA。
And as we mentioned in our presentation, that would be in September.
正如我們在演示文稿中提到的那樣,那將是在 9 月。
Erez Vigodman - CEO
Erez Vigodman - CEO
And Umer, on the first one, it's too early to comment on pricing of SD-809.
而 Umer,關於第一個問題,現在就 SD-809 的定價發表評論還為時過早。
I think it's just entertained all of the relevant milestones on a step by step basis.
我認為它只是一步一步地處理了所有相關的里程碑。
First the approval for HD, and then conduct successfully these clinical trials that relates to tardive dyskinesia, and the same (inaudible) competitive landscape.
首先批准 HD,然後成功進行這些與遲發性運動障礙和相同(聽不清)競爭格局相關的臨床試驗。
And then we will strike the right price, in order to generate value to patients and in order to be smart on the way we manage, basically given molecules from a different indication from the same molecule.
然後我們將製定合適的價格,以便為患者創造價值,並在我們管理的方式上變得聰明,基本上是從同一分子的不同適應症中獲得分子。
Umer Raffat - Analyst
Umer Raffat - Analyst
Got it.
知道了。
But Erez, just to be clear, would you reprice it once Tardive is approved, or would you just go with one pricing for both, or is it something TBD?
但是,埃雷茲,需要明確的是,一旦 Tardive 獲得批准,你會重新定價嗎?或者你會為兩者採用一種定價,還是待定?
Erez Vigodman - CEO
Erez Vigodman - CEO
TBD.
待定。
Umer Raffat - Analyst
Umer Raffat - Analyst
Got it.
知道了。
Operator
Operator
The next question comes from the line of Jason Gerberry.
下一個問題來自 Jason Gerberry。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
Hi, thank you for taking my questions.
你好,謝謝你回答我的問題。
A question for Siggi.
一個 Siggi 的問題。
Just can you comment at all, for the pro forma entity as you look at it maybe for the last three to five years going backwards, what was the average annual new product sales contribution for the generics business?
你能不能評論一下,對於你看過去三到五年的備考實體,仿製藥業務的年平均新產品銷售貢獻是多少?
Just trying to get a sense, Teva used to provide this disclosure three or four years ago.
只是想了解一下,Teva 在三四年前曾提供過這種披露。
And I think it's important because as we look forward to your math, it implies something like $600 million to $700 million in annual new generic product contribution.
我認為這很重要,因為當我們期待你的數學時,它意味著每年新的通用產品貢獻大約 6 億到 7 億美元。
So just wanted to have a sense of where we've been coming from, to how we get to that number?
所以只是想了解一下我們從哪裡來,我們是如何達到這個數字的?
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
Yes, Jason, thanks for that.
是的,傑森,謝謝你。
I think on the Actavis side, obviously, I have the benefit of knowing that internally.
我認為在 Actavis 方面,顯然,我有內部了解這一點的好處。
That was achieved every year, because there was a significant that was the key to the Actavis Generics business model, and I can confirm that in the Teva at least for the last year, because I know the numbers very well for 2015, we achieved more than 10% new product revenues from new product launches last year.
這是每年都實現的,因為有一個重要的是 Actavis Generics 商業模式的關鍵,我可以確認至少在去年的 Teva,因為我非常了解 2015 年的數字,我們實現了更多超過 10% 的新產品收入來自去年的新產品發布。
So it can be achieved with the investment in the pipeline we are talking about for sure.
所以它可以通過我們正在談論的管道投資來實現。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
Great.
偉大的。
And if I can just get my follow-up in so.
如果我能跟進的話。
There's a little bit of discussion on the CGR landscape around some of the IP that [Laboris] had, and I'm curious if there's any plan to try to enforce that IP, if that might create freedom to operate issues for any other CGRP players in the market?
關於 [Laboris] 擁有的一些 IP 的 CGR 格局有一些討論,我很好奇是否有任何計劃嘗試強制執行該 IP,如果這可能會為任何其他 CGRP 播放器創造操作問題的自由在市場上?
Thanks.
謝謝。
Erez Vigodman - CEO
Erez Vigodman - CEO
We don't want to discuss it at this stage.
我們不想在這個階段討論它。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
Okay, thank you.
好的謝謝你。
Operator
Operator
Your next question comes from the line of Mark Goodman.
你的下一個問題來自 Mark Goodman。
Marc Goodman - Analyst
Marc Goodman - Analyst
Good morning, a few things.
早上好,有幾件事。
So first, I just want to confirm, so previously, we had divestitures that were supposed to be below $1 billion, now they're going to be little bit above $1 billion.
所以首先,我只想確認,之前我們的資產剝離應該低於 10 億美元,現在它們將略高於 10 億美元。
We had a cost cutting plan before, of a certain amount.
我們之前有一個一定數量的成本削減計劃。
And now that cost cutting is going to be bigger, such that the net number which is the accretion to earnings from the deal, will basically be about the same as you thought before?
而現在成本削減幅度將更大,以至於交易收益的淨增幅基本上與您之前想像的大致相同?
That's question number one.
這是第一個問題。
I just want to confirm that.
我只是想確認一下。
Second, the specialty products, if you look across the board, the ones that you disclosed Azilect, ProAir, QVAR, I mean, they all seem to be pretty much above what everybody was expecting.
其次,專業產品,如果你全面觀察,你披露的 Azilect、ProAir、QVAR,我的意思是,它們似乎都遠遠超出了每個人的預期。
So just curious, why was their inventory build?
所以很好奇,為什麼他們的庫存會增加?
And then maybe Siggi, just give us color around the key countries outside of the United States, what's going on -- a little more color than what was in the press release?
然後也許是 Siggi,請給我們介紹一下美國以外主要國家/地區的顏色,這是怎麼回事——比新聞稿中的顏色多一點?
Thanks.
謝謝。
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
Yes, so on.
是的,等等。
Maybe I'll take one and three.
也許我會拿一個和三個。
So you're correct, on the first question, we are listed about $1 billion, and we are very confident to achieve the same net synergy number as before.
所以你是對的,關於第一個問題,我們列出了大約 10 億美元,我們非常有信心實現與以前相同的淨協同數字。
So tour assumption is fully correct.
所以旅遊假設是完全正確的。
With regards to the international market, we have a good performance in international.
關於國際市場,我們在國際上有很好的表現。
We were under a little bit of pressure.
我們承受了一點壓力。
There is increased pricing pressure in UK.
英國的定價壓力越來越大。
We have seen that, and the same in France.
我們已經看到了這一點,在法國也是如此。
But we also have a good performance.
但是我們也有不錯的表現。
We saw a better performance than we expected in Italy, Germany, and in Spain, where the environment has changed.
我們在環境發生變化的意大利、德國和西班牙看到了比預期更好的表現。
There's a new guidance in terms of discounts and things like that.
在折扣和類似的事情方面有一個新的指導。
So we are sitting at the same table, as the local producers in Spain which means a lot.
所以我們坐在同一張桌子上,作為西班牙當地的生產商,這意義重大。
I think our business in Russia has been performing extremely well, both on the generics side, but also on both the brand and OTC side.
我認為我們在俄羅斯的業務表現非常好,無論是在仿製藥方面,還是在品牌和 OTC 方面。
Obviously still challenging currency, the ruble but doing well.
顯然仍具有挑戰性的貨幣,盧布卻表現不俗。
And obviously, from first of April, the environment for Japan changed completely with the joint venture from Takeda in Japan, changes the business model.
顯然,從 4 月 1 日開始,日本的環境隨著武田在日本的合資企業而徹底改變,改變了商業模式。
We are going to talk about that in more details in the second quarter results in August, explain a little bit of the impact of the joint venture, and how that is going.
我們將在 8 月份的第二季度業績中更詳細地討論這一點,解釋一下合資企業的影響以及進展情況。
So overall, I was very pleased with the international.
所以總的來說,我對國際隊感到非常滿意。
We are still under some pressure due to FX.
由於外匯,我們仍然承受著一些壓力。
But overall, there's a net growth in the business, we see both in the growth markets, but also in Europe.
但總的來說,業務出現了淨增長,我們在增長市場和歐洲都看到了這一點。
Erez Vigodman - CEO
Erez Vigodman - CEO
And on the specialty, just to maybe start, we guided by the market by January 14, on how we are going to see the next three years, in terms of our existing specialty portfolio, with strong focus on how we manage the life cycle, and we are just delivering on the promises.
在專業方面,也許只是開始,我們在 1 月 14 日之前以市場為導向,關於我們將如何看待未來三年,就我們現有的專業產品組合而言,重點關注我們如何管理生命週期,我們只是在兌現承諾。
In the respiratory, that's firstly and fore-mostly, the new business that we are growing, and that's the intention to continue doing it in the future, the strategy of Teva here is to put a strong focus basically on improving the adherence and compliance of patients, and growing new business basically, and to at least offset the consequences of our ProAir's loss of exclusivity.
在呼吸方面,首先是我們正在發展的新業務,這是未來繼續這樣做的意圖,Teva 在這裡的戰略是將重點放在提高依從性和依從性上患者,並基本上發展新業務,並至少抵消我們 ProAir 失去獨家經營權的後果。
That's -on respiratory.
那是 - 呼吸。
On Azilect, we just again guided the market that we plan to launch the product in the key international markets.
在 Azilect 上,我們剛剛再次引導市場,我們計劃在主要國際市場推出該產品。
And at the end of the day, to be able to protect something in 50% of the franchise going forward.
在一天結束的時候,能夠保護未來 50% 的特許經營權。
So we are just delivering on that on step by step basis.
因此,我們只是逐步實現這一目標。
And on Copaxone, maybe I think maybe, Rob, you would like to comment on Copaxone.
關於 Copaxone,也許我想,Rob,你想對 Copaxone 發表評論。
Rob Koremans - President and CEO, Global Specialty Medicines
Rob Koremans - President and CEO, Global Specialty Medicines
Yes, Erez, thank you.
是的,埃雷茲,謝謝你。
So but just as a straightforward answer to the question, no there is no inventory build in the good results of specialty in this quarter.
因此,就像對問題的直接回答一樣,本季度專業的良好結果沒有庫存增加。
And then I think we addressed Copaxone before, the amount continues to be strong.
然後我認為我們之前解決了 Copaxone,數量繼續強勁。
We are number one in new patients in the US, and also number one Copaxone with 40-milligram in the US, and Copaxone is the number one in new patients in Germany.
我們在美國新病人第一,40毫克的Copaxone在美國也是第一,Copaxone在德國新病人第一。
We see incredibly strong conversion to the 40-milligram, which is a very nice and competitive product, and future in that sense, is really looking really good, as patients and doctors continue to really appreciate the products, and appreciate it so much, that it's the first choice in the two key countries.
我們看到向 40 毫克的轉換非常強勁,這是一種非常好的和有競爭力的產品,從這個意義上說,未來真的看起來非常好,因為患者和醫生繼續真正欣賞這些產品,並且非常欣賞它,以至於這是兩個關鍵國家的首選。
And overall performance of specialty has been good.
專業綜合表現良好。
And as I said already, that should be not driven by inventory build.
正如我已經說過的,這不應該由庫存構建驅動。
Thank you.
謝謝你。
Erez Vigodman - CEO
Erez Vigodman - CEO
So maybe just to maybe let you look at the fact, that by the end of 2014 or of 2015, inventory levels that related to Copaxone were very, very low.
所以也許只是讓你看看這個事實,到 2014 年底或 2015 年,與 Copaxone 相關的庫存水平非常非常低。
Today we are at normal basically inventory levels by the end of Q1 2015 -- Q1 2016.
今天,到 2015 年第一季度 - 2016 年第一季度末,我們的庫存基本處於正常水平。
Operator
Operator
Your next question comes from David Morris.
你的下一個問題來自大衛·莫里斯。
David Morris - Analyst
David Morris - Analyst
Good morning, Erez and Siggi.
早上好,Erez 和 Siggi。
Today you mentioned biosimilars, that you're looking to expand the pipeline with some biosimilar further biosimilar exposure.
今天你提到了生物仿製藥,你正在尋求通過一些生物仿製藥進一步的生物仿製藥曝光來擴大管道。
So given that Teva rarely says that they are looking to do something, and then doesn't do it.
因此,鑑於 Teva 很少說他們正在尋求做某事,然後就沒有去做。
So maybe you could describe what you're looking for?
所以也許你可以描述你在找什麼?
And then just remind us what the state of the current Teva biosimilar pipeline is?
然後提醒我們當前 Teva 生物仿製藥管道的狀態如何?
Thank you.
謝謝你。
Erez Vigodman - CEO
Erez Vigodman - CEO
So maybe I'll start, so we promise that during 2016, we'll basically be able to address a Wave 2, and clear direction for Wave 3, in a pursuing potential collaboration and partnerships, with (inaudible) that might bolster, in a way that might bolster our biosimilar pipeline.
所以也許我會開始,所以我們承諾在 2016 年期間,我們基本上能夠解決第 2 波,並為第 3 波明確方向,尋求潛在的合作和夥伴關係,(聽不清)可能會加強,在一種可能會加強我們的生物仿製藥管道的方法。
We are basically, have every intention, and plan to deliver on that promise during 2016.
我們基本上、完全有意併計劃在 2016 年兌現這一承諾。
Michael Hayden - Head of R&D and Chief Scientific Officer
Michael Hayden - Head of R&D and Chief Scientific Officer
And David, where we are currently is, that we have one product in late stage development, we have biosimilars of Humira it's in the public domain.
大衛,我們目前的情況是,我們有一種產品處於後期開發階段,我們有 Humira 的生物仿製藥,它在公共領域。
And then three, Wave 3 biosimilars in development, relatively early development.
然後是第三波,第三波生物仿製藥正在開發中,開發相對較早。
But we have the infrastructure basically to develop our own biosimilars.
但我們基本上擁有開發自己的生物仿製藥的基礎設施。
We have an outstanding biologic group around the world.
我們在世界各地擁有一支傑出的生物學團隊。
We have the regulatory affairs and IP knowledge to do this, And really the reason why we are looking for a partnership here, especially around Wave 2 because we have a gap in our pipeline around Wave 2, and maybe some of the early Wave 3 products where we simply don't have the time to catch up.
我們擁有監管事務和知識產權知識來做到這一點,這也是我們在這裡尋找合作夥伴關係的真正原因,尤其是圍繞第 2 波,因為我們在第 2 波以及可能是某些早期第 3 波產品的管道中存在差距我們根本沒有時間趕上。
In terms of where we are in the market today, we have a revenue of the Wave 1 biosimilars of approximately $300 million to $400 million on a yearly basis.
就我們目前在市場上的位置而言,我們的 Wave 1 生物仿製藥每年的收入約為 3 億至 4 億美元。
These are the old versions, of course, [Epo, phil CAST stream PEGylated, phil CAST stream] et cetera are doing well.
這些是舊版本,當然,[Epo、phil CAST stream PEGylated、phil CAST stream] 等等都做得很好。
But we also have the infrastructure to sell these products.
但我們也有銷售這些產品的基礎設施。
And I think maybe as the last point here is, we recognize that to sell biosimilars today and going forward, you need to be both a specialty company and generic company.
而且我認為也許這裡的最後一點是,我們認識到要在今天和未來銷售生物仿製藥,您需要既是專業公司又是仿製藥公司。
Because I think that's the key to be able to market these products going forward.
因為我認為這是能夠將這些產品推向市場的關鍵。
I think we are the ideal partner in this way.
我認為我們是這方面的理想合作夥伴。
But as Erez mentioned focus on the partnership is on Wave 2, and maybe early Wave 3. But we're looking for ourselves, for development of other Wave 3 products.
但正如 Erez 提到的那樣,合作夥伴關係的重點是第 2 波,也許是第 3 波的早期。但我們正在尋找自己,以開發其他第 3 波產品。
David Morris - Analyst
David Morris - Analyst
Just as a follow-up though, based on your commentary, should we expect or is it your goal to have something, or a start of that augmentation policy or strategy put in place by the end of this year?
不過,作為後續行動,根據您的評論,我們是否應該期望或您的目標是在今年年底之前有一些東西,或者開始實施增強政策或戰略?
Erez Vigodman - CEO
Erez Vigodman - CEO
The answer is yes.
答案是肯定的。
David Morris - Analyst
David Morris - Analyst
Great.
偉大的。
Thank you very much.
非常感謝。
Kevin Mannix - Head of IR
Kevin Mannix - Head of IR
Operator?
操作員?
Operator
Operator
The next question comes from the line of Sumant Kulkarni.
下一個問題來自 Sumant Kulkarni。
Sumant Kulkarni - Analyst
Sumant Kulkarni - Analyst
Hi, thanks for taking my questions.
您好,感謝您回答我的問題。
Siggi, actually both for you.
Siggi,實際上兩者都適合你。
On generic pricing erosion, we heard a lot, but especially on alternate dosage pharma like topicals, are those as attractive products as they used to be, given everything going on in the market place?
關於仿製藥價格下降,我們聽到了很多,但特別是在外用藥物等替代劑量藥物方面,考慮到市場上發生的一切,這些產品是否像過去一樣具有吸引力?
And second, what are your latest thoughts on potential for getting generic an AB rating for your generic EpiPen?
其次,您對仿製 EpiPen 獲得仿製 AB 評級的潛力有何最新看法?
Siggi Olafsson - President and CEO, Global Generic Medicines
Siggi Olafsson - President and CEO, Global Generic Medicines
Thanks, Sumant.
謝謝,蘇曼特。
I'm pleased we didn't have a call without an EpiPen question.
我很高興我們沒有在沒有 EpiPen 問題的情況下接到電話。
I think first on pricing on different dosage forms.
我首先考慮不同劑型的定價。
It depends a little bit of the situation in the market.
這在一定程度上取決於市場情況。
You probably remember, Sumant, that in the year 2009, nobody wanted to be in the injectables.
Sumant,你可能還記得,在 2009 年,沒有人願意注射。
And then we obviously had that quality issue in the injectable space.
然後我們顯然在可注射領域遇到了質量問題。
And then two years later, everybody wanted to be in injectables.
兩年後,每個人都想注射。
So on topicals now, I think there is some pricing pressure.
所以現在就主題而言,我認為存在一些定價壓力。
You've seen that maybe in the companies that are more exposed to topicals like Perigo and Sando, to some extent they have been talking about more pricing pressure than we have been talking about, or Mylan or Allergan, so that could be a reason.
你已經看到,也許在像 Perigo 和 Sando 這樣更容易受到話題影響的公司中,在某種程度上,他們一直在談論比我們一直在談論的更大的定價壓力,或者 Mylan 或 Allergan,所以這可能是一個原因。
Overall, in topicals, the competition is a little bit less.
總的來說,在話題中,競爭要少一些。
We are talking about usually maybe three to five competitors in the market, where you have on commodities maybe 18,19 -- up to 18,19 competitors.
我們談論的通常是市場上的三到五個競爭對手,在商品上可能有 18,19 個——最多 18,19 個競爭對手。
But currently, we are not that exposed to topicals ourselves.
但目前,我們自己並沒有那麼接觸到話題。
We have some products, but we also a very interesting pipeline on topicals going forward, where it's -- where we when we combine with Actavis Generics, we will have a first-to-file opportunities on topicals.
我們有一些產品,但我們也有一個非常有趣的關於未來主題的管道,它在哪裡 - 當我們與 Actavis Generics 結合時,我們將有一個關於主題的第一個申請機會。
But regarding the EpiPen, as we mentioned before, we got a Complete Response Letter from the FDA.
但是關於 EpiPen,正如我們之前提到的,我們收到了 FDA 的完整回复信。
We were seeking advice from the FDA.
我們正在尋求 FDA 的建議。
The FDA offered us to get further advice on the letter we are getting right now.
FDA 向我們提供了關於我們現在收到的信件的進一步建議。
We are building a strategy.
我們正在製定戰略。
We are till fully committed to this development, There will be a delay obviously due to the Complete Response Letter.
我們完全致力於這一發展,由於完整的回复信,顯然會有延遲。
We have not finalized our strategy.
我們還沒有最終確定我們的戰略。
We are working with our partner Antares on the final strategy for this product.
我們正在與我們的合作夥伴 Antares 合作制定該產品的最終戰略。
But I want to reemphasize, we are still fully committed to this product, but we don't know how much the delay will be until we can introduce an AB rated EpiPen.
但我想再次強調,我們仍然完全致力於這個產品,但我們不知道在推出 AB 級 EpiPen 之前會有多少延遲。
Sumant Kulkarni - Analyst
Sumant Kulkarni - Analyst
Thank you.
謝謝你。
Operator
Operator
That does conclude the question-and-answer session.
問答環節到此結束。
I'll now hand the call back to Erez Vigodman, President and CEO for final comments.
我現在將電話轉回給總裁兼首席執行官 Erez Vigodman,以徵求最終意見。
Erez Vigodman - CEO
Erez Vigodman - CEO
So thank you, everyone for participating this morning, at the outset of a new week, and have a great week.
因此,感謝大家今天早上在新的一周開始時參加,祝大家度過愉快的一周。
Operator
Operator
Thank you.
謝謝你。
That does conclude the conference for today.
今天的會議到此結束。
Thank you for participating, and you may all disconnect.
感謝您的參與,你們可能都會斷開連接。