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 Pharmaceutical Industries third-quarter 2016 results call.
女士們,先生們,感謝你們的支持,歡迎來到 Teva Pharmaceutical Industries 2016 年第三季度業績電話會議。
I must advise you this conference is being recorded today, Tuesday, November 15, 2016.
我必須告訴你,今天,即 2016 年 11 月 15 日,星期二,我們正在錄製這次會議。
I would now like to hand over the conference to Kevin Mannix, Senior Vice President, Investor Relations.
我現在想將會議交給投資者關係高級副總裁 Kevin Mannix。
Thank you, please go ahead, sir.
謝謝,請繼續,先生。
Kevin Mannix - SVP of IR
Kevin Mannix - SVP of IR
Thank you, Lawrence.
謝謝你,勞倫斯。
Thank you for joining us today to discuss Teva's third-quarter 2016 financial results.
感謝您今天加入我們討論 Teva 2016 年第三季度的財務業績。
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, Chief Legal Officer.
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;研發部首席科學官Michael Hayden博士;全球運營總裁兼首席執行官 Carlo De Notaristefani 博士;和首席法務官 David Stark。
We will start the call with presentations from Erez, Siggi and Eyal before opening the call up for questions and answers.
我們將以 Erez、Siggi 和 Eyal 的演講開始電話會議,然後再開始電話會議以進行問答。
A copy of today's press release and slides can be found on our website, Tevapharm.com under the Investor Relations section, as well as on the Teva Investor Relations app.
今天的新聞稿和幻燈片的副本可以在我們的網站 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。
During this call, we will be making forward-looking statement, which are predictions, projections, or other statements about future events.
在此次電話會議中,我們將做出前瞻性聲明,即對未來事件的預測、預測或其他聲明。
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 數據不包括已購無形資產的攤銷、與某些監管行動相關的成本、庫存增加、法律結算和準備金、減值以及相關稅收影響。
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 管理層和董事會用於評估公司運營績效、與公司工作計劃和預算進行比較並最終評估管理層績效的結果。
Teva provides such non-GAAP data to investors as supplemental data, and not in substitution or replacement for GAAP results, because management believes such data provides useful information to investors.
Teva 向投資者提供此類非 GAAP 數據作為補充數據,而不是替代或替代 GAAP 結果,因為管理層認為此類數據為投資者提供了有用的信息。
And with that, I'll now turn the call over to our 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。
Hello, everyone.
大家好。
Thank you all for joining us today to discuss our financial results for the third quarter of 2016.
感謝大家今天加入我們討論我們 2016 年第三季度的財務業績。
Before I start, I would like to make a personal note.
在我開始之前,我想做一個個人筆記。
I want to acknowledge the passing of a dear friend and colleague, Richard Egosi.
我要感謝一位親愛的朋友和同事 Richard Egosi 的去世。
Rich was an integral part of Teva for over 21 years, serving most recently as our Chief Legal Officer.
Rich 是 Teva 不可或缺的一部分超過 21 年,最近擔任我們的首席法務官。
He was a pillar of strength and integrity, with passion, professionalism and innovative thinking, left a remarkable legacy.
他是力量和正直的支柱,以熱情、專業和創新思維,留下了非凡的遺產。
He will be greatly missed.
人們會非常想念他。
I've often noted on our quarterly calls, and in my discussions with all of you that 2016 is truly a year of transition for Teva.
我經常在我們的季度電話會議上以及在與大家的討論中指出,2016 年對 Teva 來說確實是過渡的一年。
Throughout the year, we have completed key moves highlighted by the closing in August of our purchase of Actavis generics business.
在這一年中,我們完成了重要的舉措,如 8 月完成對 Actavis 仿製藥業務的收購。
I'm very proud of the role that the employees of Teva have done to get us to the finish line, of all of them and begin integrating them into Teva.
我為 Teva 的員工為幫助我們到達終點並開始將他們整合到 Teva 中所發揮的作用感到非常自豪。
This will serve us well in building our long-term future, and achieving our mission of providing the Company with a balanced and diversified portfolio of levers of growth, which we believe will create lasting shareholder value.
這將有助於我們建設長期的未來,實現我們為公司提供平衡和多元化的增長槓桿組合的使命,我們相信這將創造持久的股東價值。
I want to start by briefly discussing our third-quarter results.
我想首先簡要討論一下我們第三季度的業績。
Eyal will take you through a much deeper dive of the numbers in just a few minutes.
Eyal 將在幾分鐘內帶您更深入地了解這些數字。
This was an important quarter for Teva, with the first in time inclusion of Actavis generics.
對於 Teva 來說,這是一個重要的季度,它首次及時納入了 Actavis 仿製藥。
Our total net revenues of $5.6 billion for the quarter were up 15% compared to the third quarter of 2015.
我們本季度的總淨收入為 56 億美元,與 2015 年第三季度相比增長了 15%。
This includes two months of Actavis generics, which contributed approximately $890 million to the top line.
這包括兩個月的 Actavis 仿製藥,為收入貢獻了約 8.9 億美元。
Our non-GAAP operating income for the quarter was up 16% compared to Q3 2015, while non-GAAP EBITDA and net income were up 16% and 17%, respectively.
與 2015 年第三季度相比,我們本季度的非 GAAP 營業收入增長了 16%,而非 GAAP EBITDA 和淨收入分別增長了 16% 和 17%。
Our non-GAAP EPS declined 3% year-over-year as expected, due to the dilutive effect in the first year of the additional shares used to help finance the transaction.
我們的非 GAAP 每股收益如預期的那樣同比下降 3%,這是由於第一年用於幫助為交易融資的額外股份的稀釋效應。
Our cash flow from operations was also strong at $1.5 billion.
我們的運營現金流也很強勁,達到 15 億美元。
In addition, we received approximately $1.7 billion from the proceeds of 79 divested products in the United States required by the FTC to satisfy the conditions for completing the Actavis acquisition.
此外,我們從美國 79 種剝離產品的收益中獲得了 FTC 要求的約 17 億美元,以滿足完成對 Actavis 收購的條件。
The completion of the Actavis acquisition strengthens and broadens our R&D capabilities, and highly complements our product pipeline, product portfolio, geographical footprint and operational network.
Actavis 收購的完成加強和拓寬了我們的研發能力,並高度補充了我們的產品線、產品組合、地理足跡和運營網絡。
It enhances Teva's leadership in an evolving competitive landscape and massive consolidation across our customer base.
它增強了 Teva 在不斷變化的競爭格局和我們客戶群的大規模整合中的領導地位。
In addition, our integration plans with the Actavis generics business are on track.
此外,我們與 Actavis 仿製藥業務的整合計劃正在按計劃進行。
Looking at our specialty pipeline, in the third quarter, an important highlight was our Company's resubmission in response to the FDA's Complete Response Letter for SD-809 for Huntington Disease.
看看我們的專業管道,在第三季度,一個重要的亮點是我們公司重新提交以回應 FDA 對 SD-809 亨廷頓病的完整回應函。
In October, we were pleased to report that the FDA had accepted the resubmission and assigned a PDUFA date of April 3, 2017.
10 月,我們很高興地報告 FDA 已接受重新提交並指定 PDUFA 日期為 2017 年 4 月 3 日。
And by the end of this year, we plan to submit an application for SD-809 for the treatment of tardive dyskinesia, after having completed successfully the second pivotal Phase III study which met primary and secondary endpoints.
並且在今年年底之前,我們計劃在成功完成滿足主要和次要終點的第二個關鍵 III 期研究後,提交 SD-809 用於治療遲發性運動障礙的申請。
In September, we announced a collaboration with Regeneron to develop and commercialize fasinumab, an investigational NGF antibody for chronic pain.
9 月,我們宣布與 Regeneron 合作開發和商業化 fasinumab,這是一種用於慢性疼痛的研究性 NGF 抗體。
We believe fasinumab has the potential to provide treatment option for chronic pain without the concerns of abuse addiction and misuse of opioids.
我們相信 fasinumab 有可能為慢性疼痛提供治療選擇,而無需擔心濫用成癮和濫用阿片類藥物。
The collaboration will result in incremental specialty R&D spend in the fourth quarter of 2016, and for the next few years.
此次合作將在 2016 年第四季度和未來幾年增加專業研發支出。
Lastly, soon after the quarter ended, in early October, we are pleased to announce an exclusive partnership with Celltrion to commercialize certain biosimilar products leveraging on Teva's unique cross-functional capabilities in specialty and generic medicine.
最後,在本季度結束後不久,即 10 月初,我們很高興地宣布與 Celltrion 建立獨家合作夥伴關係,利用 Teva 在專科和仿製藥方面獨特的跨功能能力,將某些生物仿製藥產品商業化。
Before I discuss the focus for Teva moving forward, I would like to acknowledge that while 2016 is indeed the year of transition, it has also been a challenging one for Teva and the entire industry.
在我討論 Teva 前進的重點之前,我想承認雖然 2016 年確實是轉型之年,但對 Teva 和整個行業來說也是充滿挑戰的一年。
I would like to address a few Teva-specific challenges now.
我現在想解決一些 Teva 特有的挑戰。
As mentioned in today's earnings release, we are in settlement discussions with the US Department of Justice and the Securities and Exchange Commission to fully resolve the previously disclosed FCPA investigation.
正如今天的收益報告中所述,我們正在與美國司法部和證券交易委員會進行和解討論,以完全解決先前披露的 FCPA 調查。
The conduct under discussion relates to three countries, Russia, Mexico and Ukraine, during the time period covering 2007 to 2013.
所討論的行為涉及 2007 年至 2013 年期間的三個國家,即俄羅斯、墨西哥和烏克蘭。
In light of the advanced stage of this discussion, we are now establishing a provision for approximately $520 million in the third quarter.
鑑於此次討論已進入後期階段,我們現在正在為第三季度撥備約 5.2 億美元。
None of the conduct of question involved Teva's US business.
有問題的行為均未涉及 Teva 的美國業務。
We are looking forward to putting this matter fully behind us as soon as possible, and we have addressed in a robust way the issues that gave rise to it as follows.
我們期待盡快徹底解決這個問題,並且我們已經以強有力的方式解決了引起它的問題,如下所示。
Upon learning of FCPA concern in 2012, we accelerated the pace of changes to address these issues by completely transforming our governance program and processes on every level.
在 2012 年得知 FCPA 問題後,我們加快了變革步伐,通過在各個層面徹底轉變我們的治理計劃和流程來解決這些問題。
This resulted in actions including terminating problematic business relationships with third-parties, separating relevant employees from the Company, fully overhauling the management of several subsidiaries, ceasing operations in several countries, and even disbanding entire business units.
這導致採取的行動包括終止與第三方存在問題的業務關係、將相關員工從公司中分離出來、全面改革數家子公司的管理、停止在多個國家/地區的運營,甚至解散整個業務部門。
We have also restructured the Company through a new global organization structure and chain of command that reduces risk.
我們還通過降低風險的新的全球組織結構和指揮鏈對公司進行了重組。
In order to institute a culture of compliance throughout the organization, we have also trained tens of thousands of employees on compliance measures, protocols and best practices.
為了在整個組織內建立合規文化,我們還對數万名員工進行了合規措施、協議和最佳實踐方面的培訓。
Since becoming Teva's CEO in 2014, I have made compliance a top priority in everything we do.
自 2014 年成為 Teva 的首席執行官以來,我一直將合規作為我們所做一切的重中之重。
The compliance program that Teva has in place is serious, rigorous and comprehensive, and is designed to protect the Company and its subsidiaries against future violations.
Teva 制定的合規計劃是嚴肅、嚴格和全面的,旨在保護公司及其子公司免受未來違規行為的侵害。
Today, Teva has a compliance culture that begins with a strong tone at the top, including our executive regional and local management, a culture of compliance that underpins every single business decision that Teva makes.
如今,Teva 的合規文化始於高層的強勢基調,包括我們的區域和地方行政管理人員,這種合規文化支撐著 Teva 做出的每一項業務決策。
Next, I'd like to turn to our acquisition of RIMSA in Mexico.
接下來,我想談談我們對墨西哥 RIMSA 的收購。
In September, Teva filed a lawsuit again the sellers of RIMSA for fraud, as well as breached representation and warranties in the purchase agreement, after Teva uncovered evidence of systematic information manipulation regarding the drug development and manufacturing that were carried out over an extended period of time.
9 月,Teva 再次對 RIMSA 的銷售商提起欺詐訴訟,以及違反購買協議中的陳述和保證。時間。
These violations were concealed from us, during the due diligence process by presenting us with false records.
在盡職調查過程中,通過向我們提供虛假記錄,我們隱瞞了這些違規行為。
We did not disclose the situation in RIMSA earlier, as we attempted to address the situation with the local agencies, and then negotiate a settlement with the seller.
我們之前沒有透露RIMSA的情況,因為我們試圖與當地機構解決這個問題,然後與賣家協商解決。
We have put in place a full remediation plan to address the issues identified.
我們已經制定了完整的補救計劃來解決所發現的問題。
We believe that over time, we will be able to realize the opportunities that the Mexican market provides for us.
我們相信,隨著時間的推移,我們將能夠意識到墨西哥市場為我們提供的機會。
Finally, I cannot conclude this part of my remarks without briefly addressing the US Department of Justice investigation into price collusion in the generic drug industry, which has been in the news this month.
最後,在結束我的這一部分發言之前,我不能不簡要談談美國司法部對仿製藥行業價格串通的調查,這已成為本月的新聞。
I would like to emphasize that based on all of our efforts to date, internal and external, we disclosed, and I'm reiterating it here today, that we are not aware of any fact that would give rise to an exposure to Teva with respect to the investigation.
我想強調的是,根據我們迄今為止所做的所有努力,無論是內部還是外部,我們都披露了,並且我今天在此重申,我們不知道有任何事實會引起對 Teva 的尊重到調查。
Let me now turn, and provide you with an overview of the near-term focus for Teva.
現在讓我轉過來,向您概述 Teva 的近期重點。
It is very clear to our management and Board what the priorities must be fulfilled.
我們的管理層和董事會非常清楚必須滿足哪些優先事項。
A significant amount of capital has been deployed over the last 12 months to acquire assets and partner with other companies, in order to enhance our existing levers of growth, as well as create new ones.
在過去的 12 個月裡,我們投入了大量資金來收購資產並與其他公司合作,以增強我們現有的增長槓桿,並創造新的增長槓桿。
Now it is time for Teva to step away for the foreseeable future from executing material BD deals, and to focus all of its energy on organic growth, and extracting all of the deal-related synergies, and unlocking the maximum value from the deal.
現在,Teva 是時候在可預見的未來放棄執行重大 BD 交易,將所有精力集中在有機增長上,提取所有與交易相關的協同效應,並從交易中釋放最大價值。
We are determined to use the deals as a catalyst to transform Teva even further, and drive even more efficiencies throughout the entire organization, with a focus on cash flow generation and paying down our debt.
我們決心利用這些交易作為催化劑,進一步改造 Teva,並在整個組織中提高效率,重點是產生現金流和償還債務。
For our generics business, this means capturing cost synergies while driving organic growth through new launches around the globe, especially in the United States, while constantly replenishing our pipeline through our industry-leading R&D.
對於我們的仿製藥業務,這意味著通過在全球範圍內(尤其是在美國)推出新藥來實現成本協同效應,同時推動有機增長,同時通過行業領先的研發不斷補充我們的產品線。
We leverage the combined portfolio infrastructure of Teva and Actavis generics and maximize value from our market-leading position.
我們利用 Teva 和 Actavis 仿製藥的組合產品組合基礎設施,並從我們的市場領先地位中最大化價值。
For our specialty business, this means successful execution in the development and commercialization of our key pipeline assets, most notably our anti-CGRP product for migraine, SD-809, and fasinumab, and further expanding our pipeline through in-house development programs.
對於我們的專業業務,這意味著成功執行我們關鍵管道資產的開發和商業化,最引人注目的是我們用於偏頭痛的抗 CGRP 產品、SD-809和 fasinumab ,並通過內部開發計劃進一步擴展我們的管道。
By the same time, we continue to protect Copaxone in multiple ways.
與此同時,我們繼續以多種方式保護 Copaxone。
2017 will be an important year for Copaxone, as we await the decision of the lower court on several patents protecting Copaxone 40 milligram.
2017 年對於 Copaxone 來說將是重要的一年,因為我們等待下級法院就保護 Copaxone 40 毫克的幾項專利做出裁決。
It is our intention now to focus on using our cash flow to pay down our current level of debt.
我們現在打算專注於使用我們的現金流來償還我們目前的債務水平。
Today we benefit from an investment grade rating, and it is very important for Teva that we maintain it, and even make it stronger over time.
今天,我們受益於投資級評級,對於 Teva 來說,保持它非常重要,甚至隨著時間的推移使其變得更強大。
And with that, I will now turn the call over to Siggi to review our generics business.
有了這個,我現在將把電話轉給 Siggi 來審查我們的仿製藥業務。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Thanks, Erez, and good morning, everyone.
謝謝,Erez,大家早上好。
This quarter was one of monumental change for Teva's global generic medicines business.
本季度是 Teva 全球仿製藥業務的重大變化之一。
On August 2, we completed the strategic acquisition of Actavis generics.
8月2日,我們完成了對阿特維斯仿製藥的戰略收購。
The result is a much stronger, more competitive Teva that is best positioned to thrive in an evolving global generics marketplace.
結果是 Teva 變得更強大、更具競爭力,最有能力在不斷發展的全球仿製藥市場中蓬勃發展。
We also announced the acquisition of Anda, the fourth largest distributer of generics in the US, which closed shortly after the end of the quarter.
我們還宣布收購美國第四大仿製藥分銷商 Anda,該收購在本季度結束後不久完成。
The acquisition of Anda reflects our belief that distribution capabilities are very complementary to our pharma business, and Anda provides an important service for many of our customers, as well as our competitors.
收購 Anda 反映了我們的信念,即分銷能力與我們的製藥業務非常互補,Anda 為我們的許多客戶以及我們的競爭對手提供重要服務。
The combination of these businesses expands our growth opportunities and the value we can bring to our customers and the US healthcare system.
這些業務的結合擴大了我們的增長機會以及我們可以為客戶和美國醫療保健系統帶來的價值。
Turning to the performance of our global generics business in the third quarter.
談談我們第三季度全球仿製藥業務的表現。
Total revenues were $2.9 billion, an increase of 32% compared to third quarter of 2015, reflecting the results of operation of the Actavis generics business from August 2, 2016 or approximately two months contribution.
總收入為 29 億美元,與 2015 年第三季度相比增長 32%,反映了 Actavis 仿製藥業務自 2016 年 8 月 2 日以來的運營結果或大約兩個月的貢獻。
The two months of Actavis contributed $887 million in revenues.
Actavis 的兩個月貢獻了 8.87 億美元的收入。
No revenues from Anda were included in third quarter.
第三季度未計入安達的收入。
In the US, there was a small decline in the Teva legacy generics business, which mainly resulted from a loss of exclusivity, and intensified competition for generic versions of Pulmicort, Nexium and Xeloda.
在美國,Teva 遺留仿製藥業務出現小幅下滑,這主要是由於喪失了獨占權,以及普米克、耐信和希羅達仿製藥的競爭加劇。
As I've stated before, new product launches are crucial for growth over any period of time, and there was a lack of significant new product launches during the third quarter.
正如我之前所說,新產品的發布對於任何時期的增長都至關重要,第三季度缺乏重要的新產品發布。
This was attributable to delays in product approvals and the IP decisions, as well as quality challenges experienced by third-party suppliers.
這歸因於產品批准和知識產權決策的延遲,以及第三方供應商遇到的質量挑戰。
These delays will likely impact fourth quarter as well, pushing some of the larger launch opportunities into 2018 and 2017.
這些延遲也可能影響第四季度,將一些更大的發布機會推到 2018 年和 2017 年。
This quarter, the price erosion on our US-based business was approximately 7% versus a year ago.
本季度,我們美國業務的價格與一年前相比下降了約 7%。
This is slightly higher than our expectation going into the quarter, with a key driver being increased price pressure on select products as we divested some of the Teva/Actavis overlaps, and they transitioned to the new owners.
這略高於我們對本季度的預期,一個關鍵的驅動因素是特定產品的價格壓力增加,因為我們剝離了 Teva/Actavis 的一些重疊部分,並將它們轉移給了新的所有者。
This created some temporary market instability for these lower competition products.
這為這些競爭較低的產品造成了一些暫時的市場不穩定。
Despite this, we are very confident that the price erosion we experienced in the US will continue to be in the mid single-digits as we have guided throughout the year.
儘管如此,我們非常有信心,我們在美國經歷的價格下跌將繼續保持在我們全年指導的中等個位數。
As we have shared in the past, our broad portfolio, strong pipeline of new launches, and the durability of our more differentiated products continues to set Teva apart from many in the industry.
正如我們過去所分享的那樣,我們廣泛的產品組合、強大的新品發布渠道以及我們更具差異化產品的耐用性繼續使 Teva 在業內脫穎而出。
Compared to third quarter 2015 and adjusted for divestiture, Teva standalone global generics business is down approximately $30 million in revenue.
與 2015 年第三季度相比並針對資產剝離進行了調整,Teva 獨立的全球仿製藥業務收入下降了約 3000 萬美元。
With very few product launches in the quarter, that's a really good result, and shows the strength of our underlying business.
本季度推出的產品很少,這是一個非常好的結果,並顯示了我們基礎業務的實力。
Turning to our profit margins, the generic business came in at 29.9%.
談到我們的利潤率,仿製藥業務的利潤率為 29.9%。
By exercising strong focus on cost control, and driving the right business mix, we compensated for challenges on the top line.
通過高度重視成本控制和推動正確的業務組合,我們彌補了收入方面的挑戰。
The closing of the Actavis transaction has gone very smoothly since day one, with no operational disruption.
Actavis 交易的結束從第一天開始就非常順利,沒有出現運營中斷。
While we were disappointed at the delay with the anti-trust review, the time allowed the integration teams of Teva and Actavis generics to work diligently to plan for integration of the two companies, in order to ensure that combined Company would be fully operational immediately upon closing of the transaction.
雖然我們對反壟斷審查的延遲感到失望,但時間允許 Teva 和 Actavis 仿製藥的整合團隊努力工作以規劃兩家公司的整合,以確保合併後的公司能夠立即全面運營交易結束。
As a result, Teva was able to begin capitalizing immediately on the benefits offered by the acquisition of Actavis generics.
因此,Teva 能夠立即開始利用收購 Actavis 仿製藥所帶來的好處。
This included optimizing our R&D activities, harmonizing our customer contracts and relationships, and realizing economies of scale with our purchasing.
這包括優化我們的研發活動、協調我們的客戶合同和關係,以及通過我們的採購實現規模經濟。
We also continued with the integration of the joint venture in Japan.
我們還繼續整合在日本的合資企業。
Full distribution integration was achieved by the end of the quarter, and we are very pleased with our partnership with Takeda.
到本季度末實現了全面的分銷整合,我們對與武田的合作夥伴關係感到非常滿意。
As Erez discussed, we continued the integration of RIMSA despite the challenges.
正如 Erez 所討論的,儘管面臨挑戰,我們仍繼續整合 RIMSA。
We are committed to the Mexican market, and we are working hard to leverage the assets from RIMSA as the basis to drive our growth in the region.
我們致力於墨西哥市場,我們正在努力利用 RIMSA 的資產作為推動我們在該地區增長的基礎。
Our global generics R&D effort continued to produce new files around the world.
我們的全球仿製藥研發工作繼續在世界各地產生新文件。
Most notably, we continue to lead the industry in the US.
最值得注意的是,我們繼續引領美國的行業。
On first-to-files, which is still a significant value driver in the US generic market, this year Teva has received confirmation of 23 new first-to-files, which is approximately half of the total number posted by the FDA, and more than [80%] of the total first-to-file brand value posted in 2016.
在先申請方面,這仍然是美國仿製藥市場的重要價值驅動因素,今年 Teva 已收到 23 個新的先申請的確認,大約佔 FDA 發布總數的一半,等等超過 2016 年公佈的首次申請品牌總價值的 [80%]。
10 of these 23 first-to-files occurred in third and fourth quarter, and we hope for several more by year-end.
這 23 個首次提交的文件中有 10 個發生在第三和第四季度,我們希望到年底還有更多。
New launches are the life blood of any generics business, and are key to any company's ability to grow both the top and bottom lines.
新品上市是任何仿製藥業務的命脈,也是任何公司能否實現收入和利潤增長的關鍵。
With the acquisition, Teva now has more than 2,000 product registrations pending approval around the world, and we have significant value in our more than 100 confirmed first-to-files for the US markets.
通過此次收購,Teva 現在在全球有 2,000 多個產品註冊等待批准,我們在美國市場的 100 多個已確認的首次申請中具有重要價值。
These include potential opportunities to launch generic alternative products to Nuvaring, Viagra, Axiron and Byetta, and many others in the next 12 to 24 months.
其中包括在未來 12 至 24 個月內推出 Nuvaring、Viagra、Axiron 和 Byetta 以及許多其他產品的通用替代產品的潛在機會。
In closing, we strongly believe in the generic industry for the long-term, despite the current volatility.
最後,我們堅信仿製藥行業的長期發展,儘管目前存在波動。
With our recent investments, Teva is the best positioned Company in terms of market presence, manufacturing capabilities and pipeline, and I see this business growing mid single-digits going forward.
通過我們最近的投資,Teva 在市場佔有率、製造能力和產品線方面是處於最佳位置的公司,我認為該業務未來將以中等個位數增長。
We bring tremendous value to our customers and savings to the global healthcare system, generics are part of the solution.
我們為客戶帶來巨大價值並為全球醫療保健系統節省開支,仿製藥是解決方案的一部分。
As I've mentioned previously, short-term volatility will always show up in the generic business, but over the long-term, we see profitability and growth.
正如我之前提到的,短期波動總是會出現在仿製藥業務中,但從長期來看,我們會看到盈利能力和增長。
And with that, I will now turn the call over to Eyal.
有了這個,我現在將把電話轉給 Eyal。
Eyal Desheh - CFO
Eyal Desheh - CFO
Thank you very much, Siggi.
非常感謝,西吉。
Good morning, and good afternoon, everyone.
大家早上好,下午好。
I would now like to walk you through some of the highlights of our financial results for the third quarter and the first nine months of 2016.
現在,我想向您介紹我們 2016 年第三季度和前九個月財務業績的一些亮點。
This was a good quarter, the first to combine Teva and Actavis generics businesses.
這是一個很好的季度,第一個合併了 Teva 和 Actavis 仿製藥業務。
Our GAAP results that shows first, which include a number of one-time item which I will discuss in a few slides, showed net income and earnings per share improvement compared to Q3 2015.
我們的 GAAP 結果首先顯示,其中包括我將在幾張幻燈片中討論的一些一次性項目,顯示淨收入和每股收益與 2015 年第三季度相比有所改善。
Looking at the non-GAAP results, all-in all it was a good quarter, with 15% inorganic growth in revenue, which was complemented by 16% growth in EBITDA and 17% growth in net income.
從非 GAAP 業績來看,總的來說這是一個不錯的季度,收入無機增長 15%,EBITDA 增長 16%,淨收入增長 17%。
Non-GAAP earnings per share was $1.31, $0.04 lower than last year, resulting from the increase in number of shares following the Actavis acquisition.
非 GAAP 每股收益為 1.31 美元,比去年低 0.04 美元,這是由於收購 Actavis 後股票數量增加所致。
Cash flow from operations and free cash flow were up nicely compared to last year.
與去年相比,運營現金流和自由現金流都有很好的增長。
We generated a strong $1.5 billion in cash flow from operations.
我們從運營中產生了 15 億美元的強勁現金流。
It was up 34% compared to Q3 2015.
與 2015 年第三季度相比增長了 34%。
We had a number of one-time items this quarter, as well as costs associated with the acquisition of Actavis.
本季度我們有許多一次性項目,以及與收購 Actavis 相關的成本。
Non-GAAP adjustment include the provision for the anticipated FCPA settlement with the government, the investment with Regeneron, which is classified as in-process R&D, a gain from divesting certain Teva products as part of the Actavis deal, and increasing amortization and dealer-related inventory step-up, and the corresponding tax impact of all of that.
非 GAAP 調整包括預期與政府達成 FCPA 和解的準備金、與 Regeneron 的投資(被歸類為在研研發)、作為 Actavis 交易的一部分剝離某些 Teva 產品的收益,以及增加攤銷和經銷商-相關庫存增加,以及所有這些相應的稅收影響。
Our financial leverage increased to 50% as a result of the borrowing needs to finance the Actavis acquisition, and debt to EBITDA is 5.4 times at the end of the quarter.
由於收購 Actavis 需要藉貸,我們的財務槓桿增加到 50%,本季度末 EBITDA 的債務是 5.4 倍。
We expect this ratio to improve to under 3.5 times 18 months following the close of the transaction, in order to protect our BBB rating.
我們預計該比率將在交易結束後的 18 個月內提高至 3.5 倍以下,以保護我們的 BBB 評級。
Following the transaction, EBITDA increased to over $1.9 billion this quarter.
交易完成後,本季度 EBITDA 增至 19 億美元以上。
Now let's look at what happened to revenues.
現在讓我們看看收入發生了什麼變化。
In this view, we separated the products we had to divest as part of the Actavis deal.
從這個角度來看,我們將必須剝離的產品作為 Actavis 交易的一部分進行了分離。
You can see that in the separate column of $105 million in divestitures.
你可以在 1.05 億美元資產剝離的單獨列中看到這一點。
It was split approximately 50/50 between the legacy Teva and the Actavis business.
它在遺留的 Teva 和 Actavis 業務之間分成大約 50/50。
Without these divested products, Actavis two-month sales added about $940 million, and the legacy Teva generics business was in total $30 million down year-over-year.
如果沒有這些剝離的產品,阿特維斯兩個月的銷售額增加了約 9.4 億美元,而遺留的 Teva 仿製藥業務總額同比下降了 3000 萬美元。
Important to note, however, that the Teva generic sales this quarter included additional $150 million in sales from the Teva/Takeda joint venture in Japan, which were not included last year.
然而,值得注意的是,本季度 Teva 仿製藥銷售額包括來自日本 Teva/Takeda 合資企業的額外 1.5 億美元銷售額,去年未包括在內。
Looking at the original breakdown, US is now 52% of our total sales, Europe is 25%, and the rest of the world is 23%.
從最初的細分來看,美國現在占我們總銷售額的 52%,歐洲佔 25%,世界其他地區佔 23%。
Generics accounted for 52% of our sales.
仿製藥占我們銷售額的 52%。
Copaxone was 19% of our sales, and specialty products were 18% of our total sales.
Copaxone 占我們銷售額的 19%,特種產品占我們總銷售額的 18%。
Our non-GAAP operating profit, this measure excludes G&A, was up 16% year-over-year.
我們的非 GAAP 營業利潤(該指標不包括 G&A)同比增長 16%。
Generics including Actavis contributed additional operating profit of more than $300 million to our operating profit, and our operating profit from our specialty business was down by $120 million year-over-year, all in all, a 16% increase.
包括 Actavis 在內的仿製藥為我們的營業利潤貢獻了超過 3 億美元的額外營業利潤,而我們的特種業務的營業利潤同比下降了 1.2 億美元,總計增長了 16%。
And when we look at the contribution to total operating profits, generics accounted for 41% compared to 31% last year, and Copaxone was 42% as compared to 47% last year.
當我們查看對總營業利潤的貢獻時,仿製藥佔 41%,而去年為 31%,Copaxone 為 42%,而去年為 47%。
So the profit contribution from our generic business and Copaxone is almost even this quarter.
因此,我們的仿製藥業務和 Copaxone 的利潤貢獻幾乎與本季度持平。
The margin of our generic business continued to be healthy, with 50.5% in gross margin and 29.9% in operating margin.
我們仿製藥業務的利潤率繼續保持健康,毛利率為 50.5%,營業利潤率為 29.9%。
In Copaxone, total Copaxone sales posted another over $1 billion quarter, of just 2% less than Q3 last year due to losing the tender in Russia.
在 Copaxone,Copaxone 的總銷售額又一個超過 10 億美元的季度,由於在俄羅斯的招標失敗,僅比去年第三季度減少 2%。
We experienced good sales in Europe, and a fast adoption of Copaxone 40 milligram.
我們在歐洲取得了良好的銷售業績,並迅速採用了 Copaxone 40 毫克。
Now let's take a quick look at the year-to-date results.
現在讓我們快速瀏覽一下年初至今的結果。
Looking at our three quarters results, it is important to remember that they include only two months of the Actavis business.
查看我們的三個季度業績,重要的是要記住它們只包括兩個月的 Actavis 業務。
Net income for the period was 6% up year-over-year, and EPS was 9% down due to the higher number of shares.
該期間的淨收入同比增長 6%,每股收益因股票數量增加而下降 9%。
For the first three quarters of 2016, our generic business was 48% of total sales, and it was 36% of our total operating income, with Copaxone was 45% of total operating income.
2016 年前三個季度,我們的仿製藥業務佔總銷售額的 48%,佔總營業收入的 36%,而 Copaxone 佔總營業收入的 45%。
The picture in Q3, of course, is very different.
當然,第三季度的情況非常不同。
Dividend: in its meeting yesterday, our Board of Directors approved a $0.34 per share quarterly dividend, together with the preferred dividend of the MCPS total dividend is estimated be $410 million for the quarter.
股息:在昨天的會議上,我們的董事會批准了每股 0.34 美元的季度股息,連同 MCPS 本季度總股息的優先股息估計為 4.1 億美元。
I would like to update the guidance for the full year-ending December 31, 2016.
我想更新截至 2016 年 12 月 31 日的全年指引。
We now expect net sales of $21.6 billion to $21.9 billion, and diluted non-GAAP earnings per share of $5.10 to $5.20, with an estimated fully diluted number of shares of 1.020 billion shares for the full year, and share count for Q4 exiting 2016 is expected to be 1.080 billion shares.
我們現在預計淨銷售額為 216 億美元至 219 億美元,稀釋後的非 GAAP 每股收益為 5.10 美元至 5.20 美元,預計全年完全稀釋後的股票數量為 10.2 億股,2016 年第四季度的股票數量為預計為10.80億股。
Regarding 2017, as always this time of the year, we are working on the 2017 AOP, annual operating plan.
關於 2017 年,每年這個時候,我們都在製定 2017 年 AOP,即年度運營計劃。
We will communicate our forecasted plans for 2017, together with the Q4 results in early February.
我們將在 2 月初公佈我們 2017 年的預測計劃以及第 4 季度的結果。
Thank you all for listening to our remarks and comments this morning.
感謝大家今天早上聆聽我們的發言和評論。
And now we will be -- we will like to open the call for questions.
現在我們將 - 我們想開始提問。
Operator
Operator
Thank you.
謝謝你。
(Operator Instructions)
(操作員說明)
Your first question comes from the line of Louise Chen.
你的第一個問題來自Louise Chen。
Louise Chen - Analyst
Louise Chen - Analyst
Hi, thanks for taking my two questions here.
您好,感謝您在這裡提出我的兩個問題。
So first question I had was on your tax rate, and why it came in lower than expected?
所以我的第一個問題是關於你的稅率,為什麼低於預期?
And then, secondly could you talk more on the magnitude of the OTC beat that was driven by the Venezuela FX?
然後,其次,您能否更多地談談委內瑞拉外匯推動的場外交易的規模?
Thanks.
謝謝。
Eyal Desheh - CFO
Eyal Desheh - CFO
Okay, this is Eyal.
好的,我是 Eyal。
Thank you for your question.
謝謝你的問題。
Regarding the tax rate, you'll remember we guided it, as of the combination of Teva and Actavis, we expect our tax rate to be -- at the range of between 16% to 18%.
關於稅率,您會記得我們指導過它,對於 Teva 和 Actavis 的合併,我們預計我們的稅率將在 16% 到 18% 之間。
This quarter, it was just below the low end of this range of 15.9%.
本季度,它略低於該範圍 15.9% 的低端。
Our expectation going forward is within that original range.
我們對未來的預期在最初的範圍內。
Regarding Venezuela, Venezuela, this quarter posted about $280 million in total sales.
關於委內瑞拉,委內瑞拉本季度的總銷售額約為 2.8 億美元。
There was more OTC sales than generic Rx sales.
OTC 銷售額高於仿製藥 Rx 銷售額。
In the mix this quarter, remember we share the profit of the OTC results with the PGT partnership with Proctor & Gamble, so Teva will only record half of that.
在本季度的組合中,請記住我們與寶潔公司的 PGT 合作夥伴分享場外交易結果的利潤,因此 Teva 只會記錄其中的一半。
Total results of Venezuela this quarter in the bottom line were lower than Q2 and Q1, represented just about $0.02 per share for the total result of the Company.
委內瑞拉本季度的總業績低於第二季度和第一季度,僅占公司總業績每股約 0.02 美元。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
And maybe Louise to add to the OTC, you'll also need to keep in mind, that there was an extra two months of Actavis business which contributed to the OTC line.
也許 Louise 將添加到 OTC,您還需要記住,Actavis 的業務額外增加了兩個月,這為 OTC 產品線做出了貢獻。
There was a portfolio of Actavis OTC products which is solely sold by Teva, and that increased the revenue and the profitability of the OTC line also.
有一系列由 Teva 獨家銷售的 Actavis OTC 產品,這也增加了 OTC 產品線的收入和盈利能力。
Louise Chen - Analyst
Louise Chen - Analyst
Thank you.
謝謝你。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Vamil Divan.
你的下一個問題來自 Vamil Divan。
Vamil Divan - Analyst
Vamil Divan - Analyst
Great.
偉大的。
Thanks so much for taking my questions.
非常感謝你回答我的問題。
Just two if I could.
如果可以的話,只有兩個。
One, I appreciate your comments regarding the guidance for this year.
第一,我感謝您對今年的指導意見。
Can you just discuss -- you've obviously given longer term guidance as well before, and do you still stand by those numbers, or when might we get an update on your views for the outer years beyond 2016?
你能不能討論一下——你之前顯然也給出了更長期的指導,你是否仍然堅持這些數字,或者我們什麼時候可以更新你對 2016 年之後的看法?
And then, second, just around your comments you made around generic drug pricing, you mentioned that 7% erosion this quarter, but you said you're confident it will still remain in the mid single-digits going forward.
然後,其次,圍繞你對仿製藥定價的評論,你提到本季度有 7% 的侵蝕,但你說你有信心未來仍將保持在個位數中間。
So can you just maybe provide a little bit more insight, there's obviously an area that there's a lot of investor focus, just what gives you the confidence that what's going to happen in the coming quarters will be different than what you saw this quarter?
那麼您能否提供更多的見解,顯然有一個領域有很多投資者關注,只是什麼讓您有信心未來幾個季度將發生的事情將與您在本季度看到的不同?
Thanks.
謝謝。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes, so it's Siggi here.
是的,所以這裡是 Siggi。
Let me start on the drug pricing, so overall, like previous quarters, there hasn't been any fundamental change in the US drug pricing.
讓我從藥品定價開始,總體而言,與前幾個季度一樣,美國藥品定價沒有任何根本性變化。
And what we saw in the difference between the 5% or mid single-digit we guided for going into it, versus exiting at 7%, was the impact of the pricing impact on the divested product.
我們在我們指導的 5% 或中個位數與退出 7% 之間的差異中看到的是定價對剝離產品的影響。
As we mentioned, to close the transaction and to fulfill the requirement of the FTC, we had to divest 79 products in the US.
正如我們提到的,為了完成交易並滿足 FTC 的要求,我們不得不剝離美國的 79 種產品。
And these products have limited competition, and that's why we had to divest them.
這些產品的競爭有限,這就是我們不得不剝離它們的原因。
So our customer views the opportunity of the instability of the market, so there was more pricing pressure, during the time when the transaction happened on these 79 or a little bit less marketed products that were in the market.
因此,我們的客戶看到了市場不穩定的機會,因此在交易發生在市場上的這 79 種或稍少的營銷產品上時,定價壓力更大。
So we saw that, we saw a little bit increase in pricing.
所以我們看到了,我們看到價格略有上漲。
But the underlying market itself, the competition in the market is in line with what we have seen for the first two quarters of the year, we saw the same in third quarter.
但基礎市場本身,市場競爭與我們今年前兩個季度所看到的一致,我們在第三季度看到了同樣的情況。
And our expectation going into the fourth quarter is the same, or similar price erosion in the mid single-digit.
我們對進入第四季度的預期是相同或類似的中個位數價格下跌。
Erez Vigodman - CEO
Erez Vigodman - CEO
Vamil, we are working out now a bottom up assessment of the opportunities and challenges.
Vamil,我們現在正在對機遇和挑戰進行自下而上的評估。
We see as part of our comprehensive annual operating planning process for 2017, we plan to complete that process as in every other year, early next year, and to provide you with our 2017 guidance when we report our fourth quarter 2016 results in early February.
作為我們 2017 年綜合年度運營規劃流程的一部分,我們計劃像往年一樣在明年年初完成該流程,並在我們於 2 月初報告 2016 年第四季度業績時向您提供我們 2017 年的指導。
This guidance will include the comprehensive review of our expectations for all of our businesses, including the scenario of generic competition to 40 milligram Copaxone.
該指南將包括對我們對所有業務的期望的全面審查,包括與 40 毫克 Copaxone 進行仿製藥競爭的情景。
Vamil Divan - Analyst
Vamil Divan - Analyst
Okay, thank you.
好的謝謝你。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Tim Chiang.
你的下一個問題來自Tim Chiang。
Tim Chiang - Analyst
Tim Chiang - Analyst
Hi, thanks.
你好謝謝。
Erez, Eyal, could you talk a little bit about just the revised guidance for operating cash flow?
埃雷茲、埃亞爾,你能談談經修訂的經營現金流量指南嗎?
What's going into that?
這是怎麼回事?
And also what do you expect for the fourth quarter in terms of new product launches?
您對第四季度的新產品發布有何期待?
And also in the first half of 2017, do you expect a recovery on the new product launch cycle?
並且在2017年上半年,您預計新產品發布週期會恢復嗎?
Eyal Desheh - CFO
Eyal Desheh - CFO
Should I start with the cash flow?
我應該從現金流入手嗎?
Yes, so we revised our operating cash flow down by $300 million to $400 million, as a result of what we are seeing.
是的,因此我們將運營現金流量下調了 3 億美元至 4 億美元,這是我們所看到的結果。
Some payments that we inherited with the account payable of the Actavis transaction were a bit higher than what we had expected, and other than that, cash flow is very well intact as we have seen.
我們從 Actavis 交易的應付賬款中繼承的一些付款比我們預期的要高一些,除此之外,正如我們所看到的,現金流非常完好。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
So Tim, on the new launches, it's Siggi here.
所以蒂姆,在新品發布會上,這裡是 Siggi。
I think first of all, obviously we're very dependent on both the approval by the regulatory agencies.
我認為首先,顯然我們非常依賴監管機構的批准。
We have over 90 cases ongoing in Paragraph IV challenges in the US, so we're dependent obviously on IP decisions.
在美國,我們有 90 多起涉及 Paragraph IV 挑戰的案件正在審理中,因此我們顯然依賴於知識產權決策。
And then on top of that, obviously, we are using API sometimes from a third-party manufacturer which could affect the approvability of our products.
然後最重要的是,很明顯,我們有時會使用來自第三方製造商的 API,這可能會影響我們產品的認可度。
In this quarter, even though I mentioned that we had no significant launch in the quarter, we still have the 11 launches in our US business.
在本季度,儘管我提到我們在本季度沒有重大發布,但我們在美國業務中仍有 11 次發布。
So there were 11 launches, we still maintain to be a launch machine to grow the business.
所以有 11 次發射,我們仍然保持作為發射機來發展業務。
The challenge was, these were relatively small launches in the overall scheme of things.
挑戰在於,這些都是整體計劃中相對較小的發射。
And as I mentioned in my prepared remarks, in fourth quarter we don't see any significant large launch coming in fourth quarter.
正如我在準備好的發言中提到的那樣,在第四季度我們沒有看到任何重大的大型發布。
In terms of 2017, we will take that much deeper when we guide for 2017.
就 2017 年而言,我們將在指導 2017 年時更深入地探討這一點。
But keep in mind, that Teva now has over 300 ANDA pending at the FDA, and of those 300, there could be the possibility of over 60 of them coming to the market in 2017.
但請記住,Teva 現在有 300 多個 ANDA 正在等待 FDA 批准,而在這 300 個中,2017 年可能會有超過 60 個進入市場。
But again, that depends very heavily on regulatory approvals, IP decisions, et cetera, et cetera.
但同樣,這在很大程度上取決於監管批准、知識產權決定等。
So I think we have the best portfolio to have a good launch here, but we are doing the work now, we are evaluating the IP situation, the regulatory situation, obviously of the Actavis portfolio.
所以我認為我們擁有最好的產品組合,可以在這裡進行良好的發布,但我們現在正在做這項工作,我們正在評估 IP 情況、監管情況,顯然是 Actavis 產品組合。
So in February when we guide you for 2017, we can give you a much better picture of the new launches.
因此,在 2 月我們為您介紹 2017 年時,我們可以讓您更好地了解新發布的情況。
But clearly, we have the best pipeline in the industry and we will continue to grow the Teva generic business with new launches.
但很明顯,我們擁有業內最好的管道,我們將繼續通過新產品的推出來發展 Teva 仿製藥業務。
Tim Chiang - Analyst
Tim Chiang - Analyst
Okay, great.
好,太棒了。
Thanks.
謝謝。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Ken Cacciatore.
您的下一個問題來自 Ken Cacciatore。
Ken Cacciatore - Analyst
Ken Cacciatore - Analyst
Hi, thanks, guys.
嗨,謝謝,伙計們。
Just quick question here on the business development.
關於業務發展的快速問題。
Appreciate that you're taking a pause.
感謝您暫停一下。
Just trying to understand what you're going to do to change some of the decision-making process here?
只是想了解你打算做什麼來改變這裡的一些決策過程?
Zecuity, Rimsa, the Regeneron deal, these things seem to be going bad, and not just going bad, they seem to go bad quick.
Zecuity、Rimsa、Regeneron 的交易,這些事情似乎都在變壞,而且不僅僅是變壞,它們似乎變壞得很快。
And so, trying to understand internally besides pausing, what we're doing and what we're learning, to make sure these decisions improve or get better?
因此,除了暫停之外,還試圖從內部了解我們正在做什麼和正在學習什麼,以確保這些決策得到改善或變得更好?
And then also we're spending quite a bit of money, a $1 billion on branded R&D.
然後我們也花了很多錢,10 億美元用於品牌研發。
Can you explain how it's at that level, given the pipeline as we observe it?
考慮到我們觀察到的管道,您能解釋一下它在那個級別上的情況嗎?
It seems like a really high level for a portfolio that one would think would be better than a $1 billion in annual spend?
對於人們認為會比每年 10 億美元的支出更好的投資組合來說,這似乎是一個非常高的水平?
Thank you.
謝謝你。
Dr. Michael Hayden - President of Global R&D and Chief Scientific Office
Dr. Michael Hayden - President of Global R&D and Chief Scientific Office
Well, thank you.
嗯,謝謝。
Let me just answer firstly about the pipeline.
讓我先回答有關管道的問題。
The pipeline is a very focused pipeline in our areas of particular interest, migraine and pain, movement disorders, neurodegeneration, respi.
該管道是我們特別感興趣的領域的一個非常集中的管道,偏頭痛和疼痛,運動障礙,神經變性,呼吸。
And when you look at this, as we look at the end of 2016, 29 programs.
當你看這個時,就像我們在 2016 年底看的那樣,有 29 個項目。
This is a year where we also had very significant results.
這一年我們也取得了非常顯著的成果。
We just think about the SD-809 for tardive dyskinesia, the Huntington successful resubmission, of course, 48125, our anti-CGRP which is a -- doing very well, recruitment going very well.
我們只是考慮用於遲發性運動障礙的 SD-809,亨廷頓成功重新提交,當然,48125,我們的抗 CGRP 這是一個 - 做得很好,招募進展順利。
We're looking to results in 2017.
我們期待 2017 年的結果。
We've also initiated the same TEV-48125 for cluster headaches.
我們還針對叢集性頭痛啟動了相同的 TEV-48125。
We're also continuing to develop abuse deterrent opioids, where the advisory board gave us the highest abuse deterrent claims that have thus far been supported.
我們還在繼續開發防止濫用的阿片類藥物,諮詢委員會向我們提供了迄今為止得到支持的最高濫用威懾聲明。
We are waiting for approval of that.
我們正在等待批准。
So we also are -- starting in 2017, expect to see significant organic growth from both our small molecule development, early drug development, and biologic pipeline.
因此,我們也——從 2017 年開始,預計我們的小分子開發、早期藥物開發和生物管線將實現顯著的有機增長。
So Teva has been in the process of transformation.
所以梯瓦一直在轉型。
And in fact, our specialty pipeline R&D is among the lowest in the industry, highly productive.
事實上,我們的專業管道研發是業內最低的,生產力很高。
We also are using innovation, using existing molecules, deuterated molecules, other ways to reformulate to improve compliance, efficacy, and tolerability.
我們還在使用創新,使用現有分子、氘化分子和其他重新配製的方法,以提高依從性、療效和耐受性。
And this is a very balanced portfolio, and you will be seeing additional results, 2017, a very important year for us as we look to the results of Laquinimod, a Nav1.7 antagonist for pain, the results of migraine.
這是一個非常平衡的投資組合,你會看到更多的結果,2017 年對我們來說是非常重要的一年,因為我們期待 Laquinimod 的結果,這是一種 Nav1.7 疼痛拮抗劑,偏頭痛的結果。
So this is a very active focused productive pipeline, which is expected to yield increasing value, as we go through this transformation into a balanced, both generic and specialty company.
因此,這是一個非常積極專注的生產管道,隨著我們向一家平衡的、通用的和專業的公司轉型,它有望產生越來越大的價值。
Erez Vigodman - CEO
Erez Vigodman - CEO
I can just to add to that.
我可以補充一點。
First in any event, we are looking again in 2017 on priorities.
無論如何,首先,我們將在 2017 年重新審視優先事項。
And we might end up the year with a much more focus on less initiatives in general, and the specialty also in particular, in order to really make sure that every penny we spend, moves the needle for us and creates value for us.
我們可能會在今年結束時更加關注總體上較少的舉措,尤其是專業領域,以真正確保我們花的每一分錢都能為我們帶來積極影響並為我們創造價值。
And if there are projects which don't generate value for us, I will terminate those projects.
如果有項目不能為我們創造價值,我將終止這些項目。
So that's again, we are in a process as I indicated before, of reevaluating everything we do, in order to use the transaction of the BD deals as a catalyst to transform Teva, and to take Teva to the next level, also in terms of comprehensive efficiency measure plan that is not confined just to extracting synergies from the deal.
因此,正如我之前指出的那樣,我們再次處於重新評估我們所做的一切的過程中,以便使用 BD 交易的交易作為催化劑來改造 Teva,並將 Teva 提升到一個新的水平,也是在綜合效率措施計劃,不僅限於從交易中提取協同效應。
On the third question, yes, Rimsa is a failure, and we are deeply investigating ourselves on that, in order to draw all of the conclusions from that failure.
關於第三個問題,是的,Rimsa 是一個失敗,我們正在對此進行深入調查,以便從失敗中得出所有結論。
And it doesn't denigrate of course, from all of the efforts to build a business in Mexico.
當然,這並沒有貶低在墨西哥開展業務的所有努力。
And we believe that over time, we'll be able to reach the targets that we've set for us.
我們相信,隨著時間的推移,我們將能夠實現為我們設定的目標。
Needless to say, it will take us a number of years more than what was expected initially.
毋庸置疑,這將比最初預期的花費更多的時間。
But will lead to all the basically targets that we have set for ourselves in that important market.
但這將導致我們在那個重要市場為自己設定的所有基本目標。
But that's something that of course, doesn't denigrate from the need to learn deeply what went wrong, and to draw all the conclusions from that.
但這當然不會貶低深入了解問題所在並從中得出所有結論的必要性。
And that's something that we are, of course, we are doing.
當然,這就是我們正在做的事情。
I want to really distinguish Rimsa from the other examples as you had indicated.
正如您所指出的,我想真正將 Rimsa 與其他示例區分開來。
We acquired other very -- at least to date, a successful specialty asset that we're extracting the value from them, and we'll extract the value from them over time.
我們收購了其他非常 - 至少迄今為止,我們正在從中提取價值的成功專業資產,並且我們將隨著時間的推移從中提取價值。
And Regeneron, that's a very different case compared to the Rimsa, on all relevant plans, we strongly believe in that project.
而 Regeneron,與 Rimsa 相比,這是一個非常不同的案例,在所有相關計劃中,我們堅信該項目。
It is just about time, we believe that it is just about time, until the partial hold will be basically lifted, a clinical hold will be lifted.
是時候了,我們認為是時候了,直到部分擱置基本解除,臨床擱置才會解除。
And we strongly believe in that partnership and in the potential contribution of that asset to Teva and Regeneron over time.
我們堅信這種夥伴關係以及該資產隨著時間的推移對 Teva 和 Regeneron 的潛在貢獻。
And the Zecuity, maybe I'll ask Rob to address?
還有 Zecuity,也許我會請 Rob 解決?
Rob Koremans - President & CEO Global Specialty Medicines
Rob Koremans - President & CEO Global Specialty Medicines
Okay.
好的。
First of all, Zecuity was a relatively small acquisition that we did.
首先,Zecuity 是我們進行的一項相對較小的收購。
It was an interesting opportunity, and the opportunity would have been there, but the product showed a side effect that was very difficult to predict.
這是一個有趣的機會,機會本來就在那裡,但產品出現了難以預測的副作用。
And reviewing that, what we are doing at the moment, to see where we can bring down that side effect ratio, which is going to be very difficult, because it's relating to the [iontophoresis] per se, right?
回顧一下我們目前正在做的事情,看看我們可以在哪裡降低副作用率,這將非常困難,因為它與 [離子電滲療法] 本身有關,對吧?
So I think the lesson that we took there, is with a device like Zecuity, the technology behind that, and in an indication like acute migraine where there are quite a number of alternatives available, authorities and also patients do not tolerate any increase of side effects.
所以我認為我們在那裡吸取的教訓是使用像 Zecuity 這樣的設備,以及它背後的技術,並且在像急性偏頭痛這樣有很多替代品的適應症中,當局和患者都不能容忍任何增加的邊效果。
And although we had quite a number of happy patients, people very committed to this product and the match with our pipeline with our TEV-48125 is really striking, we said we'd put the interest of the patients first here, and withdrawn the product from the market.
儘管我們有很多滿意的患者,但人們對這個產品非常投入,而且我們的管道與我們的 TEV-48125 的匹配非常驚人,我們說過我們會把患者的利益放在首位,並撤回了該產品從市場。
I think the lesson learned there is, what we have learned.
我認為那裡吸取的教訓是,我們學到了什麼。
And as I described, to put it, it was really an extremely small deal in that respect, and would have been a very nice opportunity.
正如我所描述的那樣,在這方面,這確實是一筆非常小的交易,本來是一個非常好的機會。
Ken Cacciatore - Analyst
Ken Cacciatore - Analyst
Thank you.
謝謝你。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of David Risinger.
你的下一個問題來自 David Risinger。
David Risinger - Analyst
David Risinger - Analyst
Yes, hi.
是的,嗨。
I just wanted to get a little bit more perspective on the generics business.
我只是想對仿製藥業務有更多的了解。
The Company hosted a very bullish generics meeting in early September, yet generics are disappointing, and the guidance is coming down.
公司在 9 月初舉辦了一次非常樂觀的仿製藥會議,但仿製藥令人失望,指導正在下降。
And so, could you just talk us through a little bit more detail on what you weren't aware of in early September, and how we should think about the prospects for the generics business going forward?
那麼,您能否更詳細地告訴我們一些您在 9 月初沒有意識到的事情,以及我們應該如何考慮仿製藥業務的未來前景?
Thank you.
謝謝你。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Thanks, David.
謝謝,大衛。
So first of all, I'm as bullish on the generic business today as I was on September 9 for sure.
因此,首先,我肯定和 9 月 9 日一樣看好今天的仿製藥業務。
I think the volatility you see between months, between quarters, you -- I think we all recognize that, that the volatility of new launches between quarters and between years has a significant impact, especially on the US business.
我認為你在幾個月之間、季度之間看到的波動,你——我想我們都認識到,新產品在季度和年份之間的波動具有重大影響,尤其是對美國業務。
The price erosion in the US is similar to what we expected in September.
美國的價格下跌與我們 9 月份的預期相似。
The impact on the divested product was a little bit more.
對剝離產品的影響要大一些。
I think the guidance on how we see the pricing environment is very similar as we guided to in our meeting, the difference being is basically the new launches.
我認為關於我們如何看待定價環境的指南與我們在會議上的指南非常相似,不同之處基本上在於新產品的推出。
New launches as I mentioned in the September meeting, to maintain the mid single-digit growth in our business in the US, we need to launch new products every year of between $500 million and $600 million in revenue every year from our pipeline.
正如我在 9 月的會議上提到的新產品發布,為了保持我們在美國的業務保持中個位數的增長,我們每年需要推出新產品,每年從我們的管道中獲得 5 億至 6 億美元的收入。
On where I sit today, and I see the pipeline and the pending products, the first-to-files, we mentioned the 80%, the total brand value of the first-to-files that have been filed this year is $7.1 billion.
在我今天坐的地方,我看到了管道和未決產品,第一個文件,我們提到了 80%,今年提交的第一個文件的品牌總價值為 71 億美元。
We have approximately 80% of that, including some shared first-to-file.
我們有大約 80%,包括一些共享的先申請。
So there's a lot of value there in the overall business, but the volatility will come from quarter to quarter.
因此,整體業務中有很多價值,但波動會逐季出現。
I think what we are saying here is, we didn't get the big approvals that we expected in third quarter.
我認為我們在這裡要說的是,我們沒有在第三季度獲得預期的大批准。
We don't foresee them in fourth quarter, and then we are building the plan for 2017.
我們預計第四季度不會出現這些情況,然後我們正在製定 2017 年的計劃。
But I'm as bullish of seeing the mid single-digit growth as before.
但我和以前一樣看好中個位數的增長。
But to make -- be able to do that, we simply need to deliver between $500 million and $600 million in new product revenues every year going forward, and I really see that with the pipeline that's pending.
但是要做到——能夠做到這一點,我們只需要在未來每年提供 5 億到 6 億美元的新產品收入,我真的看到了懸而未決的管道。
David Risinger - Analyst
David Risinger - Analyst
Thank you.
謝謝你。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of David Amsellem.
你的下一個問題來自 David Amsellem。
David Amsellem - Analyst
David Amsellem - Analyst
Thanks.
謝謝。
So first, just following up on the brand R&D, it's not lost on me that you called out in your programs, but do you think that there's significant efficiencies to be extracted, as you review the internal R&D pipeline, and maybe how should we think about the brand R&D spend longer term?
所以首先,只是跟進品牌研發,我並沒有忘記你在你的計劃中的呼聲,但你認為在審查內部研發管道時可以提取顯著的效率,也許我們應該如何思考關於品牌研發的長期投入?
And then secondly, I'm just trying to drill down on your pulling back from business development and M&A for the time being?
其次,我只是想深入了解您暫時退出業務發展和併購?
I mean, should we expect that in the next one to two years, you're going to completely revamp the team, and then redouble your efforts to source brand assets, particularly given that we should expect a little long-term pressure on Copaxone?
我的意思是,我們是否應該期望在接下來的一到兩年內,您將徹底改造團隊,然後加倍努力尋找品牌資產,特別是考慮到我們應該對 Copaxone 施加一點長期壓力?
How should we think about -- not really for the near-term, but more say, for 2018 or 2019?
我們應該如何考慮——不是真正的近期,而是 2018 年或 2019 年?
Thanks.
謝謝。
Dr. Michael Hayden - President of Global R&D and Chief Scientific Office
Dr. Michael Hayden - President of Global R&D and Chief Scientific Office
Thanks for the question.
謝謝你的問題。
Just on the branded R&D, I think that it's important as I've stated before, this is a highly efficient and already effective organization, in the sense of the results in terms of -- and we judge that by the number of products coming in by organic growth, and the number of submissions, and the number of approvals that we see.
就品牌研發而言,我認為這很重要,正如我之前所說,這是一個高效且已經有效的組織,就結果而言——我們根據進入的產品數量來判斷通過有機增長、提交數量和我們看到的批准數量。
But of course, and how we really moderate risk, and I think we've totally revamped is also understanding fundamental pathways, looking for other indications for drugs that have similar pathways.
但當然,我們如何真正降低風險,我認為我們已經完全改變了了解基本途徑,尋找具有相似途徑的藥物的其他適應症。
So for example, obviously SD-809 which depletes dopamine and depletes early presynaptic dopamine is useful for movement disorders, not only for Huntingtons but for also for tardive dyskinesia, where we've seen such stellar results, and also now we've embarked in Tourette's syndrome.
因此,例如,顯然 SD-809 會耗盡多巴胺並耗儘早期突觸前多巴胺,它對運動障礙很有用,不僅適用於亨廷頓氏症,也適用於遲發性運動障礙,我們已經看到瞭如此出色的結果,現在我們已經著手圖雷特綜合症。
So I think the approach that we take is really understanding deeply how these drugs work, looking at additional indications, using some of the safety and the different approaches, the CMC we already, of course, know how to do.
所以我認為我們採取的方法是真正深入了解這些藥物的工作原理,研究其他適應症,使用一些安全性和不同的方法,我們當然已經知道如何做 CMC。
So we have synergies in terms of the understanding the biochemistry, the pathways that leads us to other disorders.
因此,我們在理解生物化學方面具有協同作用,生物化學是導致我們患上其他疾病的途徑。
48125, for example, CGRP is not just useful for migraines, but also early evidence suggesting might be useful for cluster headaches.
48125,例如,CGRP 不僅對偏頭痛有用,而且早期證據表明可能對叢集性頭痛有用。
So as we go forward, of course, we are focusing more on brain and mind.
因此,隨著我們的前進,當然,我們將更多地關注大腦和思想。
We also have a significant respi portfolio that is also developing the first biologic for Teva, developed for approval this year, IL-5 antagonist, and we're looking to also refine.
我們還有一個重要的 respi 產品組合,它也在為 Teva 開發第一個生物製劑,今年開髮用於批准,IL-5 拮抗劑,我們也在尋求改進。
But we constantly are looking for ways to improve efficiencies, improve time to market, inclusion of commercial perspectives very early in the R&D development.
但我們一直在尋找提高效率、縮短上市時間、在研發開發早期就納入商業觀點的方法。
And you will expect to see -- 2017 will represent the maturity.
你會期待看到——2017 年將代表成熟。
This is, of course, as you understand, it takes awhile for building the capabilities, which we've done really over the last four to five years, 2017 we'll see a significant number of INDs that have all come organically growth through our biologic and small molecule development pipeline.
當然,正如你所理解的,建立能力需要一段時間,我們在過去四到五年中確實做到了,2017 年我們將看到大量的 IND 通過我們的有機增長生物和小分子開發管道。
These are molecules, of course, we know and that's why the need for BD is much less, as we go forward for big deals, as we're actually are growing our pipeline organically.
當然,我們知道這些是分子,這就是為什麼在我們進行大交易時對 BD 的需求要少得多,因為我們實際上正在有機地發展我們的管道。
Erez Vigodman - CEO
Erez Vigodman - CEO
So just to underscore, maybe the most important message here.
所以只是強調一下,也許這裡是最重要的信息。
We firstly focused on a number of key molecules that we have been developing internally.
我們首先關注我們一直在內部開發的一些關鍵分子。
Around that, we look for basically extending those molecules through additional conditions and indications.
圍繞這一點,我們基本上是通過額外的條件和適應症來擴展這些分子。
That's also a process which is underway.
這也是一個正在進行的過程。
We will terminate all the projects that don't add value for us, or don't move the needle for us over time.
我們將終止所有不會為我們增加價值的項目,或者隨著時間的推移不會為我們帶來好處的項目。
We might pursue a tuck-in deal which are not significant ones in terms of financial results, which are required in order to complement further our core TAs.
我們可能會尋求一項在財務結果方面並不重要的交易,這是進一步補充我們的核心 TA 所必需的。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Randall Stanicky.
你的下一個問題來自 Randall Stanicky。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Thanks, guys.
多謝你們。
Siggi, I just want to follow-up on the generics business.
Siggi,我只想跟進仿製藥業務。
If we take the third quarter revenue, and add another $400 million for the extra month of Allergan, we're run rating at about $23.8 billion.
如果我們採用第三季度的收入,並為艾爾建的額外月份再增加 4 億美元,我們的評級約為 238 億美元。
That's a $1.4 billion short of the low end of guidance that was given in July for next year.
這比 7 月份給出的明年指導低端低 14 億美元。
So I guess, my question is that guidance realistic, can you grow towards that?
所以我想,我的問題是指導是現實的,你能朝著那個方向發展嗎?
And that's before any erosion around Copaxone, so can you help us calibrate that?
那是在 Copaxone 周圍發生任何侵蝕之前,所以你能幫我們校準一下嗎?
And then I have one quick follow-up.
然後我有一個快速跟進。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes.
是的。
So Randall, I think the overall, you see the run rate of Actavis, you can take the $800 million around what, $[880 million-some-odd] in revenue, divide it by two, and you see the run rate of Actavis as it is currently.
所以蘭德爾,我認為總體而言,你可以看到 Actavis 的運行率,你可以將 8 億美元左右,[8.8 億美元左右] 的收入除以二,你就會看到 Actavis 的運行率就像現在一樣。
It's between $4.8 billion and $5 billion, which I think is in line with our expectation going into the acquisition.
它在 48 億美元到 50 億美元之間,我認為這符合我們對收購的預期。
We are very pleased with the asset, with the Actavis asset when it comes in.
我們對該資產以及 Actavis 資產的到來感到非常滿意。
I think the Teva business, as I mentioned we are a little bit under, and it's related to the hit we get on the exclusive products that we had a year ago, and not having a significant product launch, even though we have many small product launches.
我認為 Teva 業務,正如我提到的,我們有點落後,這與我們在一年前的獨家產品上獲得的成功有關,並且沒有推出重要的產品,儘管我們有很多小產品發射。
Remember last year, that the revenue from new product launches in Teva alone last year was over $800 million, which was very significant that year.
還記得去年嗎,僅去年 Teva 新產品發布的收入就超過 8 億美元,那一年是非常可觀的。
This year it will be significantly less.
今年會明顯減少。
And this variability, we see in the US product launches is the variability we see in the overall business.
我們在美國產品發布中看到的這種可變性是我們在整體業務中看到的可變性。
We are doing our work now on the pipeline.
我們現在正在籌備中開展工作。
It's a lot of work, with over 300 ANDAs pending, looking into the IP situation and regulatory situation, but the movement in the Actavis, in the generic revenue is very much dependent on revenue and opportunities from new launches.
這是一項大量的工作,有 300 多個 ANDA 正在等待審理,調查 IP 情況和監管情況,但 Actavis 的運動,仿製藥收入在很大程度上取決於新發布的收入和機會。
We have plenty of shots on goal.
我們有很多射門機會。
I'm very pleased with the pipeline.
我對管道非常滿意。
But to be able to guide you in 2017, I really need to understand the overall pipeline better, so I can give you a number where we stand in 2017.
但為了能夠在 2017 年為您提供指導,我真的需要更好地了解整個管道,所以我可以給您一個數字,說明我們在 2017 年的進展情況。
But all of the indication in terms of the status of the Actavis business, in terms of number of first-to-files, in terms of number of ANDA pending, in terms of the price erosion.
但是所有關於 Actavis 業務狀態的跡象,就首次申請的數量而言,就未決的 ANDA 數量而言,就價格侵蝕而言。
Even though we have a slightly higher pricing erosion in this quarter, there's no fundamental difference, are still intact, but you need to give us a time to validate the new launch assumptions for 2017, so we can guide you for that year.
儘管本季度我們的定價侵蝕略高,但沒有根本差異,仍然完好無損,但您需要給我們時間來驗證 2017 年的新發布假設,以便我們可以為您提供當年的指導。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
That's fair.
這還算公平。
I'm just going to ask the question, that I think a lot of people on the call are trying to understand.
我只想問這個問題,我認為電話中的很多人都在試圖理解這個問題。
Numbers have come down significantly since July.
自 7 月以來,數字已大幅下降。
So if the environment and the outlook for Teva generics and rest of the business is relatively unchanged, what are we missing?
因此,如果 Teva 仿製藥和其他業務的環境和前景相對不變,我們還缺少什麼?
What's changed since -- from July, when you looked at the business, and provided that three year guidance, whether it be on the generic side, or the brand side, what's changed that has brought numbers lower than we initially thought?
自 7 月以來發生了什麼變化,當您查看業務並提供三年指導時,無論是在通用方面還是在品牌方面,發生了什麼變化使數字低於我們最初的預期?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
What has brought the numbers lower than we thought in July for 2016 are the revenue from new launches.
2016 年 7 月的數字低於我們預期的是新發布的收入。
That's very, very simple.
這非常非常簡單。
We estimated a significantly higher -- there were about three or four key launches that we expected to get by the end of this year, which are not coming in, that would deliver the hundreds of millions in revenue which are not coming in.
我們估計要高得多——我們預計到今年年底將進行大約三到四次關鍵發布,但這些發布不會帶來數億美元的收入。
The good news, on this bad news is, they will come later.
好消息,壞消息是,他們會晚點來。
They will come in 2017 and maybe into 2018.
他們將在 2017 年到來,也許會進入 2018 年。
So they're not lost at all, but basically the simple situation is that there are hundreds of millions in new product launches that we expected before the end of this year, which will come later.
所以他們一點都沒有丟失,但基本上簡單的情況是,我們預計在今年年底之前會有數億的新產品發布,這將在晚些時候到來。
And basically moves the growth curve a little bit later in the year.
並且基本上會在今年晚些時候移動增長曲線。
And that's why you see the impact of the revenue, both in third quarter and fourth quarter this year, but it doesn't mean -- it doesn't undermine at all the fundamental of the generic business, because these are not lost opportunities.
這就是為什麼你會看到今年第三季度和第四季度的收入影響,但這並不意味著——它根本不會破壞仿製藥業務的基本面,因為這些並不是失去的機會。
These are opportunities that we are moving into next year and the year after.
這些是我們將在明年和後年進入的機會。
Erez Vigodman - CEO
Erez Vigodman - CEO
And on the back of that volatility, we have been carrying out efficiency measures, beyond what was initially expected and planned.
在這種波動的背景下,我們一直在執行效率措施,超出了最初的預期和計劃。
So that's something which is coming into play in 2016 already, and it will continue and gain more momentum in 2017.
因此,這已經在 2016 年開始發揮作用,並將在 2017 年繼續並獲得更多動力。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Okay.
好的。
Thanks, guys.
多謝你們。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Umer Raffat.
你的下一個問題來自 Umer Rafat。
Umer Raffat - Analyst
Umer Raffat - Analyst
Hi, thank you for taking my questions.
你好,謝謝你回答我的問題。
Siggi, I want to focus on US generics for a minute, and maybe just do a very simple bridge.
Siggi,我想花一分鐘時間關注美國仿製藥,也許只做一個非常簡單的橋樑。
So US generics for Teva, so Teva business only, not Actavis, was $892 million in the second quarter.
因此,Teva 的美國仿製藥,因此只有 Teva 業務,而不是 Actavis,在第二季度為 8.92 億美元。
It's $755 million this quarter, if you basically take the overall reported and subtract Actavis, so $892 million went to $755 million.
本季度為 7.55 億美元,如果你基本上採用報告的整體並減去 Actavis,那麼 8.92 億美元就達到了 7.55 億美元。
Can you make a bridge for us on, between Q2 versus Q3, sequentially what changed?
您能否為我們架起一座橋樑,在 Q2 和 Q3 之間依次發生什麼變化?
And also Siggi, what's your confidence in a 505(b)(2) Advair equivalent in February, and a possible EpiPen next year?
還有 Siggi,您對 2 月份的 505(b)(2) Advair 等價物以及明年可能的 EpiPen 有何信心?
And Eyal, perhaps one for you real quick?
Eyal,也許很快就給你一個?
So SG&A this quarter came in at about $1.2 billion, which is about the same as last quarter.
因此,本季度的 SG&A 收入約為 12 億美元,與上一季度大致相同。
So I'm just trying to understand, what did two months of Actavis contribute, and/or were there any certain non-GAAP adjustments that got us there?
所以我只是想了解,兩個月的 Actavis 做出了什麼貢獻,和/或是否有任何特定的非 GAAP 調整讓我們達到了目標?
And finally Michael, is SD-809 in Tourettes still ongoing?
最後,Michael,圖雷特症中的 SD-809 是否仍在進行中?
Thank you.
謝謝你。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
So Umer, that was a great one question.
所以 Umer,這是一個很好的問題。
So let me start on first part of your question.
那麼讓我開始你問題的第一部分。
I think if you compare the $892 million versus $755 million, these are basically the main impact on -- about half of this is the added competition on Pulmicort that we saw between second quarter and third quarter.
我認為,如果你比較 8.92 億美元和 7.55 億美元,這些基本上是主要影響——其中大約一半是我們在第二季度和第三季度之間看到的 Pulmicort 的額外競爭。
On top of that, we mentioned Xeloda, with competition, esomeprazole and Nexium, and the last one being aripiprazole.
最重要的是,我們提到了希羅達,還有競爭產品埃索美拉唑和耐信,最後一個是阿立哌唑。
These four products more than explain the gap between second quarter and third quarter, and you can even see this pretty well when you look at the IMS data for product, where basically we had some semi or exclusive position, and we have an increased competition in the third quarter.
這四個產品足以說明第二季度和第三季度之間的差距,甚至當你查看產品的 IMS 數據時,你甚至可以很好地看到這一點,基本上我們有一些半獨占地位,我們在這方面的競爭越來越激烈第三季度。
Against that, we had very low revenue from new launches, we had 11 new launches.
與此相反,我們從新發布中獲得的收入非常低,我們有 11 個新發布。
So we didn't compensate for the competition we got on these products.
所以我們沒有補償我們在這些產品上的競爭。
And so, at the end of the day, the beauty of having a huge portfolio, it gives us more stable.
因此,歸根結底,擁有龐大投資組合的美妙之處在於,它讓我們更加穩定。
But when you have a threatening or a basically competition to your key exclusive products, and you don't have the new launches to compensate for it, you will see a volatility in the revenue line.
但是,當您的主要獨家產品面臨威脅性或基本競爭,並且您沒有新產品的推出來彌補它時,您會看到收入線出現波動。
Just to come back to what Erez mentioned before, I think we have done better than anyone expected in terms of managing our cost, so we defended the bottom line more than the top line, with the product mix and control of the cost.
回到 Erez 之前提到的內容,我認為我們在管理成本方面做得比任何人預期的都要好,因此我們通過產品組合和成本控制來捍衛底線而不是頂線。
In terms of the EpiPen, we are working very closely with the FDA.
在 EpiPen 方面,我們正在與 FDA 密切合作。
I haven't changed my view, my expectation for EpiPen is still early 2018, there's nothing to change my view on that.
我沒有改變我的觀點,我對 EpiPen 的期望仍然是 2018 年初,沒有什麼可以改變我的觀點。
We are still moving forward in good collaboration with the FDA.
我們仍在與 FDA 的良好合作中向前邁進。
We had a meeting with the FDA.
我們與 FDA 舉行了會議。
We understand the way forward, what needs to be done, we think pretty well, but it hasn't changed my best estimate on the EpiPen launch.
我們了解前進的方向,需要做什麼,我們認為很好,但這並沒有改變我對 EpiPen 推出的最佳估計。
Maybe Rob you want to take the 505(b)(2) Advair product which is in the specialty group?
也許 Rob 您想購買專業組中的 505(b)(2) Advair 產品?
Rob Koremans - President & CEO Global Specialty Medicines
Rob Koremans - President & CEO Global Specialty Medicines
Well, we are, the job is on plan, on track.
嗯,我們是,工作按計劃進行,按計劃進行。
We will be launching, hopefully depending on the FDA approval both forms, the mono and the combination mid next year is our planning.
我們將推出,希望取決於 FDA 批准這兩種形式,明年年中的單聲道和組合是我們的計劃。
Dr. Michael Hayden - President of Global R&D and Chief Scientific Office
Dr. Michael Hayden - President of Global R&D and Chief Scientific Office
And just to answer the Tourette's, yes, Umer, the Tourette's program is continuing.
只是為了回答 Tourette 的問題,是的,Umer,Tourette 的計劃仍在繼續。
There's been significant discussion with the FDA initially based on the question of the metabolites that were asked for SD-809 in the HD program.
最初基於 HD 計劃中 SD-809 要求的代謝物問題,與 FDA 進行了重要討論。
We, of course, have submitted that and provided, hopefully provided reassurance, but certainly was accepted around SD-809.
當然,我們已經提交並提供了,希望提供保證,但肯定在 SD-809 周圍被接受了。
This will add impact also on the Tourette program, and so we are in discussion with the FDA, but our plan is to start the Phase III study for Tourette's in the near future.
這也將增加對圖雷特計劃的影響,因此我們正在與 FDA 進行討論,但我們的計劃是在不久的將來開始針對圖雷特的 III 期研究。
Eyal Desheh - CFO
Eyal Desheh - CFO
Umer, regarding your question about SG&A, SG&A run rate, well that's an opportunity to say a word about synergy and the progress.
Umer,關於你關於 SG&A、SG&A 運行率的問題,這是一個談論協同作用和進步的機會。
We're making very good progress on cost synergy, and tracking extremely well.
我們在成本協同方面取得了很好的進展,並且跟踪得非常好。
So expense run rate, as a result of the combination of our generics business is expected to further go down in Q4, and later on, as we have guided originally.
因此,由於我們的仿製藥業務的結合,費用運行率預計將在第四季度進一步下降,隨後,正如我們最初指導的那樣。
This is the main reason why you see the addition of two month Actavis, but no significant increase in SG&A.
這是您看到增加兩個月的 Actavis,但 SG&A 沒有顯著增加的主要原因。
Umer Raffat - Analyst
Umer Raffat - Analyst
Thank you very much.
非常感謝。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of David Maris.
你的下一個問題來自 David Maris。
David Maris - Analyst
David Maris - Analyst
Good morning.
早上好。
I'd be interested in your comments about the US policy issues facing the Company, especially with a new administration, so if you could speak broadly about maybe three efforts?
我很想知道您對公司面臨的美國政策問題的評論,尤其是在新政府的情況下,所以您是否可以廣泛地談談三項努力?
Specifically, efforts to reign in large price increases, the second to speed in more generics to market, and third the potential for reimportation, and how these might impact Teva and, more broadly speaking, pricing?
具體來說,控制價格大幅上漲的努力,其次是為了加快更多仿製藥的上市速度,第三是重新進口的潛力,以及這些可能如何影響 Teva,更廣泛地說,定價?
Thank you.
謝謝你。
Erez Vigodman - CEO
Erez Vigodman - CEO
So David, I think on the first two, we see opportunities, that's basically where we are today, we are well-positioned to I would say, strike the right balance between access and innovation in the US, and of course, also ex-US.
所以大衛,我認為在前兩個方面,我們看到了機會,這基本上就是我們今天所處的位置,我想說,我們處於有利地位,在美國的准入和創新之間取得適當的平衡,當然,還有前 -我們。
We do it ex-US today.
我們今天在美國以外的地方這樣做。
We had a business in Europe which was less, which was much less profitable a few years back, and that's a very profitable business today.
幾年前,我們在歐洲的業務規模較小,利潤少得多,但如今這是一項非常有利可圖的業務。
We told them that it was conducted under huge pressure of pricing.
我們告訴他們,這是在巨大的定價壓力下進行的。
And that's exactly what we are doing now here in the United States, look at all of the efficiency measures that we have been carrying out.
這正是我們現在在美國所做的,看看我們一直在執行的所有效率措施。
And we'll accelerate by the way, the string of efficiency measures that are conducted.
順便說一句,我們將加快執行一系列效率措施。
And I alluded to that before, and I'm underscoring it again.
我之前提到過這一點,現在再次強調。
For us, that's an opportunity to take the transformation of Teva to the next level, beyond just extracting the synergies.
對我們來說,這是將 Teva 的轉型提升到一個新水平的機會,而不僅僅是提取協同效應。
So it will be much leaner, and we'll focus on all of the things that really matter, all of the things that move the needle for us, all of the things that generate value for us.
所以它會更精簡,我們將專注於所有真正重要的事情,所有為我們帶來好處的事情,所有為我們創造價值的事情。
We'll basically get rid or terminate projects that don't meet that condition.
我們基本上會擺脫或終止不符合該條件的項目。
So in the US, with our infrastructure, with our portfolio of generics, we believe we are positioned to become part of the solution in the United States.
因此,在美國,憑藉我們的基礎設施和我們的仿製藥組合,我們相信我們有能力成為美國解決方案的一部分。
And we'll continue to basically accelerate the pace of being able to basically contribute to the solution here in the United States, more access and the right balance between access and innovation.
我們將繼續從根本上加快步伐,能夠為美國這裡的解決方案、更多的訪問以及訪問與創新之間的適當平衡做出貢獻。
As far as the FDA approvals are concerned, maybe Siggi would address that?
就 FDA 批准而言,也許 Siggi 會解決這個問題?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes, so David, it's a valid question.
是的,大衛,這是一個有效的問題。
I think first of all, on the generic approvals, we on balance, are very pleased if we get more generic approvals.
我認為首先,在仿製藥批准方面,總的來說,如果我們獲得更多的仿製藥批准,我們會非常高興。
Keep in mind is, we have just over 8% of all pending ANDAs at the FDA.
請記住,我們在 FDA 的所有未決 ANDA 中剛剛超過 8%。
And so, if there is an increase in approval speed, I think we on average get benefit from that versus, obviously there is increased competition on our product when our competitors get approval.
因此,如果批准速度有所提高,我認為我們平均會從中受益,而當我們的競爭對手獲得批准時,顯然我們的產品競爭會加劇。
So we are fully supportive of increase, and the new GDUFA too that will be in place soon, I think pushes for that, and we were a supporter of that.
所以我們完全支持增加,新的 GDUFA 也將很快到位,我認為推動它,我們是它的支持者。
But with having the largest ANDA pending at the FDA, I think we will benefit from that.
但是,由於 FDA 正在等待最大的 ANDA,我認為我們將從中受益。
I think maybe to add to the price increases, keep in mind, and we talk a lot about that, the overall prices in the US of generics always go down.
我認為可能會增加價格上漲,記住,我們談論了很多,美國仿製藥的整體價格總是下降。
I've been in the business for 23 years, and the prices, even though there are examples giving of a product going up significantly, maybe a single molecule, even one SKU, but overall, when you look at the 300 to 400 products we have on the market, our price erosion on average is about 5% per year.
我從事這項業務已有 23 年,價格,儘管有一些產品大幅上漲的例子,可能是單個分子,甚至是一個 SKU,但總的來說,當你查看 300 到 400 種產品時,我們在市場上,我們的價格平均每年下降 5% 左右。
And our generic pricing is everything from a 30% discount from the brand pricing to about 98% discount from the brand pricing.
我們的通用定價從品牌定價的 30% 折扣到品牌定價的約 98% 折扣不等。
And there is a great value, and I think that the US policy that will come in place, will probably hopefully recognize the value that the generic.
並且有很大的價值,我認為即將出台的美國政策可能有望認識到仿製藥的價值。
Because as I mentioned in my prepared remarks, we are part of the solution, we are not part of the problem.
因為正如我在準備好的發言中提到的,我們是解決方案的一部分,而不是問題的一部分。
And maybe around the reimportation, let's see how that goes, that has been on the agenda for many years.
也許圍繞重新進口,讓我們看看進展如何,這已經提上議事日程很多年了。
But keep in mind that with the pricing we have on many of our generics, the pricing on generics in the US coming from the manufacturer is lower than many of the countries around us.
但請記住,根據我們對許多仿製藥的定價,來自製造商的美國仿製藥定價低於我們周圍的許多國家/地區。
We can take obviously examples of brand products where the differences are, but when you look at everyday generics, of big volume generics where the competition in the US is fierce, the discount from the brand value is maybe 97% to 98%.
我們可以舉出差異明顯的品牌產品的例子,但是當你看日常仿製藥時,在美國競爭激烈的大批量仿製藥中,品牌價值的折扣可能是 97% 到 98%。
The pricing here is lower than in the neighboring countries.
這裡的價格低於鄰國。
So I think being a global Company with a position around the world, we need to see how it's done.
因此,我認為作為一家在全球擁有一席之地的全球性公司,我們需要看看它是如何完成的。
But overall, this doesn't scare us, and I think it puts Teva in a strong position going forward.
但總的來說,這並沒有嚇到我們,我認為這讓 Teva 處於有利地位。
Erez Vigodman - CEO
Erez Vigodman - CEO
On the specialty side David, we are always -- we believe, of course, our point of view, that we're very responsible as far as pricing was concerned.
在大衛的專業方面,我們總是 - 我們相信,當然,我們的觀點是,就定價而言,我們非常負責任。
And more than that, in all of the cases, we competed in areas where there were more than one alternative for patients.
不僅如此,在所有情況下,我們在患者有不止一種選擇的領域進行競爭。
So basically, what we witness is competition, and strong competition on the specialty side.
所以基本上,我們目睹的是競爭,以及專業方面的激烈競爭。
So all in all, we believe that with everything that we possess as a Company today, we are positioned in a good manner to deal with challenges that might emanate from policies that pertain to pricing.
因此,總而言之,我們相信,憑藉我們今天擁有的一切,我們能夠以良好的方式應對與定價相關的政策可能帶來的挑戰。
Having said that, I think that at this stage, there are still questions, a big question mark about policy that is underway, and we need to wait and see whatever we shall basically be confronted with, and how we address that.
話雖如此,我認為在現階段,仍然存在問題,對正在進行的政策打上一個大問號,我們需要拭目以待,看看我們基本上會面臨什麼,以及我們如何解決這些問題。
But bottom line as a Company, we believe that we are positioned to address the challenges that might emanate from a new policy.
但歸根結底,作為一家公司,我們相信我們有能力應對新政策可能帶來的挑戰。
David Maris - Analyst
David Maris - Analyst
Just as a follow-up, Siggi.
作為後續行動,Siggi。
So what you're saying is the acceleration in the price decreases that you've seen this past quarter aren't a result of increased competition on existing molecules, and it's not a result of having to tame previous price increases, or give back some of those?
所以你說的是你在上個季度看到的價格加速下降並不是現有分子競爭加劇的結果,也不是必須抑制之前的價格上漲或回饋一些的結果那些?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
No, basically, the main reason, David, was that we had to divest a very good portfolio of products that had limited competition, so we had to divest it.
不,基本上,大衛,主要原因是我們不得不剝離競爭有限的非常好的產品組合,所以我們不得不剝離它。
What our customers did, as they do, is that there is a new player in the market that took over those products, and that became a pricing pressure on roughly about 60 molecules of -- and these were one of our top -- the top molecules we had in our portfolio.
我們的客戶所做的,就像他們所做的那樣,是市場上有一個新的參與者接管了這些產品,這成為大約 60 分子的定價壓力 - 這些是我們的頂級產品之一 - 頂級我們投資組合中的分子。
So there was an instability that happened in the market during the month of August, when the new owners were taking market share.
因此,在 8 月份,當新所有者搶占市場份額時,市場出現了不穩定。
It didn't change the fundamental of the market.
它沒有改變市場的基本面。
It didn't change the structure of the market, or the chemistry of the market, but we saw the impact on the divested molecule significantly more than we saw for on the rest of the portfolio which gave us a 7% versus 5%, which we assumed going into the quarter.
它並沒有改變市場的結構或市場的化學成分,但我們看到對剝離分子的影響比我們對其餘投資組合的影響要大得多,後者給了我們 7% 對 5%,這我們假設進入本季度。
David Maris - Analyst
David Maris - Analyst
Great.
偉大的。
Thank you very much.
非常感謝。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Marc Goodman.
你的下一個問題來自馬克古德曼。
Marc Goodman - Analyst
Marc Goodman - Analyst
Siggi, in the past you've talked about the operating margins you believe you can get to, over the next couple years on the global generics business, now that you really do own the Allergan portfolio.
Siggi,過去你曾談到你認為在未來幾年內你可以在全球仿製藥業務中獲得的營業利潤率,現在你確實擁有艾爾建的產品組合。
Can you just talk -- talk again about those margins, just so we understand what you're thinking over the -- kind of the -- and the progression over the next couple years?
你能不能再談談這些利潤率,這樣我們就可以了解你在考慮什麼 - 以及未來幾年的進展情況?
And secondly, just in rest of the world generics, $782 million, you help us understand what was Rimsa, what was Allergan, what was Japan?
其次,就世界其他地區的仿製藥而言,7.82 億美元,你幫助我們了解什麼是 Rimsa,什麼是艾爾建,什麼是日本?
I think you said $150 million.
我想你說的是 1.5 億美元。
Just so we can understand what the apples-to-apples versus last year's Teva-only business was?
只是為了讓我們了解蘋果對蘋果與去年僅 Teva 的業務相比是什麼?
Thank you.
謝謝你。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes, so Marc, first of all, on the operating profit, I was extremely pleased with the operating profit this quarter, 29.9[%].
是的,馬克,首先,關於營業利潤,我對本季度的營業利潤 29.9[%] 感到非常滿意。
I don't expect that to come through in fourth quarter, maybe a little bit lower, we need to see how it comes.
我不認為這會在第四季度實現,可能會低一點,我們需要看看它是如何實現的。
Obviously, the mix of the portfolio when you have it for three months versus two months, the mix in terms of the new product launches, we don't foresee product launches in -- big product launches in fourth quarter.
顯然,當你擁有三個月而不是兩個月的產品組合時,新產品發布方面的組合,我們預計第四季度不會推出大型產品。
But before the close of the transaction, I said that I was hoping to see in 2017 that we would stabilize around 30%.
但是在交易結束之前,我說我希望看到2017年我們能穩定在30%左右。
So I really didn't expect us to get to 29.9% at this point in time.
所以我真的沒想到我們會在這個時間點達到 29.9%。
I think, that highlighted with, I think, early synergies, a good work around those synergies, but also a very good cost control.
我認為,我認為,這突出了早期的協同作用,圍繞這些協同作用的良好工作,同時也很好地控制了成本。
But I'm still of the opinion that we can be in the 30%s in 2017 with the right mix of product launches.
但我仍然認為,通過正確的產品發布組合,我們可以在 2017 年達到 30%。
I have to say, because maybe you didn't ask the question, but I was ready for it, Marc, around our European business.
我不得不說,因為也許你沒有問這個問題,但我已經準備好了,馬克,圍繞我們的歐洲業務。
I was very pleased with our European business in third quarter.
我對第三季度的歐洲業務感到非常滿意。
They had an outstanding quarter, they didn't miss a beat, there was a full integration in all of the Actavis market.
他們有一個出色的季度,他們沒有錯過任何一個節拍,在整個 Actavis 市場中進行了全面整合。
And the profitability in the Europe really stabilized, they're really showing amazing results.
歐洲的盈利能力真的很穩定,他們真的展示了驚人的結果。
There was no hiccup of new launches in Europe, and that was extremely pleased with the European business.
歐洲的新產品發布沒有出現問題,這對歐洲業務非常滿意。
To the apples to compare it year-over-year, I think Eyal highlighted it, in terms of there was a $30 million difference in the net revenues from third quarter of 2015 to third quarter of 2016.
對於與去年同期相比的蘋果,我認為 Eyal 強調了這一點,從 2015 年第三季度到 2016 年第三季度的淨收入有 3000 萬美元的差異。
Basically the additional revenue that the joint venture with Takeda contributed to the [2016] numbers was about $150 million.
基本上,與武田的合資企業為 [2016] 數字貢獻的額外收入約為 1.5 億美元。
The impact of Rimsa was negligible, due to the recalls we had in the market.
由於我們在市場上召回,Rimsa 的影響可以忽略不計。
We had a cost in Rimsa, so really that didn't change the overall picture.
我們在 Rimsa 中付出了代價,所以這並沒有改變整體情況。
So if you do the comparison net to net, it's about $180 million.
因此,如果您進行淨值比較,則約為 1.8 億美元。
And still I think, that is a really, really good results, comparing third quarter last year, versus this year, because of the movement of new product launches as I mentioned to the question Randall asked, has such a significant volatility impact on the overall business.
而且我仍然認為,這是一個非常非常好的結果,將去年第三季度與今年進行比較,因為正如我在 Randall 提出的問題中提到的那樣,新產品發布的變動對整體的波動性影響如此之大商業。
Marc Goodman - Analyst
Marc Goodman - Analyst
What was the Actavis contribution in rest of world versus Europe?
與歐洲相比,Actavis 在世界其他地區的貢獻是什麼?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
So we don't have the contribution, but you saw it on Eyal's revenue, there was about what, $349 million?
所以我們沒有貢獻,但你在 Eyal 的收入上看到了它,大約有 3.49 億美元?
I need to -- ?
我需要 - ?
Marc Goodman - Analyst
Marc Goodman - Analyst
$349 million.
3.49 億美元。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
$349 million was the contribution outside of the US, and really a good result.
3.49 億美元是美國以外的貢獻,確實是一個不錯的結果。
Eyal Desheh - CFO
Eyal Desheh - CFO
(multiple speakers) more or less in line with that.
(多個揚聲器)或多或少符合這一點。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes.
是的。
Kevin Mannix - SVP of IR
Kevin Mannix - SVP of IR
Next question, Lawrence?
下一個問題,勞倫斯?
Operator
Operator
Your next question comes from the line of Liav Abraham.
你的下一個問題來自 Liav Abraham。
Liav Abraham - Analyst
Liav Abraham - Analyst
Good morning.
早上好。
I just want to come back to your lower 2016 guidance, and apologies if I missed this, but can you walk us through exactly what has driven your change in revenue guidance for the year, how much do you expect in under contribution in Q4?
我只想回到你較低的 2016 年指導,如果我錯過了這一點,我深表歉意,但你能告訴我們究竟是什麼推動了你今年收入指導的變化,你預計第四季度的貢獻有多少?
And then, what offsets that, is it only performance in the generics business, or does it come from branded expectations as well?
然後,是什麼抵消了這一點,它只是仿製藥業務的表現,還是也來自品牌期望?
And then quickly secondly, can you be more specific in the economic terms of your Celltrion partnership?
其次,您能否更具體地說明與 Celltrion 合作的經濟條款?
I understand that it is a profit share, but if there are any more details you can provide, that would be helpful?
我知道這是利潤分成,但如果您能提供更多詳細信息,那會有幫助嗎?
Thank you.
謝謝你。
Eyal Desheh - CFO
Eyal Desheh - CFO
Yes so, hi, Liav, this is Eyal.
是的,嗨,Liav,我是 Eyal。
So without being too specific on splitting, we do expect the generic business to increase in contribution from Q3 to Q4 by between 7% to 8%, with similar increase in total sales, or basically a bit higher increase in total sales due to the inclusion of a fourth quarter of -- a full quarter of Activis business, and some growth in the business.
因此,無需過於具體地拆分,我們確實預計仿製藥業務從第三季度到第四季度的貢獻將增加 7% 至 8%,總銷售額也有類似的增長,或者由於包含在內,總銷售額的增長基本上略高第四季度的 - Activis 業務的整個季度,以及業務的一些增長。
We can see this in the US generic business, we can see this in the European business, mostly in these two parts.
我們可以在美國仿製藥業務中看到這一點,我們可以在歐洲業務中看到這一點,主要是在這兩個部分。
We can even see this in Canada.
我們甚至可以在加拿大看到這一點。
So there is some growth reflected, of course in the guidance, so that we have provided for the quarter, sequentially between 7% to 8% on the profit.
所以有一些增長反映出來,當然在指導中,所以我們為本季度提供了 7% 到 8% 的利潤。
Rob Koremans - President & CEO Global Specialty Medicines
Rob Koremans - President & CEO Global Specialty Medicines
On the -- yes, and on Celltrion, while we are excited about the opportunity, obviously, it's -- we are in with both Herceptin and Rituxan, we have the opportunity to be in the first wave.
在——是的,在 Celltrion 上,雖然我們對這個機會感到興奮,但很明顯,它是——我們與赫賽汀和 Rituxan 一起,我們有機會成為第一波。
It's a North America deal, so Canada and the US, where we work with Celltrion together in partnership, and we do split also the commercial profit there.
這是北美交易,所以加拿大和美國,我們與 Celltrion 一起合作,我們也在那里分享商業利潤。
We have a smaller down payment which we already did of $10 million, and there's a relative small milestone payment upon registration on that.
我們有一筆較小的首付款,我們已經支付了 1000 萬美元,並且在註冊時有相對較小的里程碑付款。
And it's a really nice opportunity for us to be partnering, with Celltrion.
對我們來說,與 Celltrion 合作是一個非常好的機會。
I'm not sure we disclosed the exact split there, so I'll have to check that, a bit reluctant to do that here.
我不確定我們在那裡披露了確切的拆分,所以我必須檢查一下,有點不願意在這裡這樣做。
Liav Abraham - Analyst
Liav Abraham - Analyst
Okay, thank you.
好的謝謝你。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Gregg Gilbert.
你的下一個問題來自 Gregg Gilbert。
Gregg Gilbert - Analyst
Gregg Gilbert - Analyst
Yes, Rob, can you comment on the potential for generic Copaxone in 2017, assuming generics are approved, and they don't wait for an appellate decision?
是的,Rob,假設仿製藥獲得批准並且他們不等待上訴決定,你能否評論 2017 年仿製藥 Copaxone 的潛力?
I'm not looking for financial guidance here, just looking for a conceptual of what you think you can do to maintain a large chunk of the franchise, in the event that it occurs in the way I described?
我不是在這裡尋找財務指導,只是尋找一個概念,如果它以我描述的方式發生,你認為你可以做些什麼來維持大部分的特許經營權?
Thanks.
謝謝。
Rob Koremans - President & CEO Global Specialty Medicines
Rob Koremans - President & CEO Global Specialty Medicines
Yes, sure, with pleasure.
是的,當然,很高興。
First of all, we're extremely pleased with Copaxone at the moment, the way it's moving, Europe launching the 40, and a similar conversion route -- rate as you've seen for the US, now at over 60% already.
首先,我們目前對 Copaxone 非常滿意,它的發展方式,歐洲推出 40,以及類似的轉換路線——就像你在美國看到的那樣,現在已經超過 60%。
And for instance, a country like France hasn't even launched yet.
例如,像法國這樣的國家甚至還沒有推出。
And in Europe, there is not going to be a substitution generic, and it's still a very substantial part of our business, right?
在歐洲,不會有替代仿製藥,它仍然是我們業務的重要組成部分,對吧?
So the business there is performing extremely well.
因此,那裡的業務表現非常出色。
We also have Canada just recently approved.
我們最近還獲得了加拿大的批准。
And if you look at the US, where we are still like in the key countries in Europe with Copaxone, they're number one, new two patients, so you'll see incredible enthusiasm for that product.
如果你看看美國,我們仍然像歐洲的主要國家一樣使用 Copaxone,他們是第一名,新的兩名患者,所以你會看到對該產品的難以置信的熱情。
And it's holding much better than I think anyone expected, both against the generics, and against oral competition there.
它比我認為任何人預期的要好得多,無論是針對仿製藥還是針對那裡的口頭競爭。
Going into 2017, the market will be a little bit more dynamic.
進入 2017 年,市場將更加活躍。
First of all, FDA hasn't approved any 40 generic, and I remain very skeptical that they will do that, because I think we have good scientific reasons for that.
首先,FDA 還沒有批准任何 40 種仿製藥,我仍然非常懷疑他們會這樣做,因為我認為我們有充分的科學理由。
If you look at today's Glatopa performance, they're about 11% of the overall Copaxone, and about just over 40% of the 20-milligram.
如果您查看今天的 Glatopa 性能,它們約佔整個 Copaxone 的 11%,約佔 20 毫克的 40%。
If you take that as a model going forward, when the generic would head to the market, and that's exactly what we've been guiding in previous calls.
如果你把它作為一個未來的模型,當仿製藥將進入市場時,這正是我們在之前的電話會議中一直在指導的。
That's not, no information to date to change my opinion on that, and wouldn't change that.
那不是,迄今為止沒有任何信息可以改變我對此的看法,也不會改變這一點。
And what we have seen though, in the last months is that Copaxone actually has been holding much better, and performance shows really good, and I'm extremely proud of all of the teams that do this.
然而,我們所看到的是,在過去幾個月中,Copaxone 實際上一直保持得更好,而且表現非常好,我為所有這樣做的團隊感到非常自豪。
Patient support programs will play an important role, and that's what we've seen people move into Glatopa in the US, often came back, actually the biggest source of new to brand comes from Glatopa changes in the US when they switch, because of the value they place on our support programs, amongst which are the shared solutions.
患者支持計劃將發揮重要作用,這就是我們看到人們在美國搬進 Glatopa,經常回來,實際上,品牌新用戶的最大來源來自美國的 Glatopa 變化,因為他們重視我們的支持計劃,其中包括共享解決方案。
So other than that, there's very little new information that we have, product is doing well, and we are optimistic about the future in that respect.
因此,除此之外,我們掌握的新信息很少,產品表現良好,我們對這方面的未來持樂觀態度。
Gregg Gilbert - Analyst
Gregg Gilbert - Analyst
Thank you.
謝謝你。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Ronny Gal.
你的下一個問題來自 Ronny Gal。
Ronny Gal - Analyst
Ronny Gal - Analyst
Good morning, and thank you for taking the questions.
早上好,感謝您提出問題。
I guess, I'll start with a couple of the branded questions.
我想,我將從幾個品牌問題開始。
On GF, Michael, what convinces you that we will not see osteoarthritis in patients who are currently not diagnosed with osteoarthritis?
關於 GF,邁克爾,是什麼讓你相信我們不會在目前未被診斷出患有骨關節炎的患者中看到骨關節炎?
I guess, that's the critical question that product, given that you could have sub clinical osteoarthritis advancing?
我想,這是該產品的關鍵問題,因為您可能患有亞臨床骨關節炎?
And second, on Advair, in Europe I believe you were not approved for all dosages of the drug?
其次,關於 Advair,在歐洲,我相信你們沒有被批准用於所有劑量的藥物?
Are you convinced you'll get all dosages of the drug in the United States, you'd obviously need all of them to get an alternative to Advair?
您是否確信您會在美國獲得所有劑量的藥物,您顯然需要所有這些藥物才能獲得 Advair 的替代品?
On the generic side, Siggi, just a quick housekeeping.
在通用方面,Siggi,只是一個快速的內務處理。
I don't know if you break for us roughly the US versus OUS profit for generics post-Actavis, just so we understand the magnitude of the risk that comes from the US pressure?
我不知道你是否為我們大致打破了 Actavis 後彷製藥的美國與美國利潤,以便我們了解來自美國壓力的風險程度?
And then more specifically on the US pressure, I understand what you did in Q3, I understand there were a few products that you divested that had a more significant pressure.
然後更具體地說,關於美國的壓力,我知道你在第三季度做了什麼,我知道你剝離了一些產品,它們承受了更大的壓力。
But we're hearing from both retailers and distributors, they're seeing pressures on that business from the MCLs, and that generally translates to further pressure on their suppliers, which means you.
但我們從零售商和分銷商那裡聽到,他們看到 MCL 給該業務帶來壓力,這通常會轉化為對供應商的進一步壓力,這意味著你。
How are you thinking about that, what tools do you have to do something about that?
你是怎麼想的,你有什麼工具來做這件事?
And as ANDA helps you, so if we think about the pressure on you in the next year, given the pressure on the entire value chain, where is your ability to compete?
由於 ANDA 可以幫助你,所以如果我們考慮明年你的壓力,考慮到整個價值鏈的壓力,你的競爭能力在哪裡?
Dr. Michael Hayden - President of Global R&D and Chief Scientific Office
Dr. Michael Hayden - President of Global R&D and Chief Scientific Office
Hi, Ronny, thank you for the question.
嗨,羅尼,謝謝你的提問。
It is important to clarify this issue.
澄清這個問題很重要。
So of course, we have as part of the development of this anti-NGF with Regeneron, fasinumab, we have -- are planning to do both a Phase III(08)study, and we'll plan to also come back with chronic low back pain.
因此,當然,作為與 Regeneron 開發這種抗 NGF 的一部分,fasinumab,我們計劃進行 III 期(08)研究,我們也計劃恢復慢性低背疼。
It's important to note that the patients who have had the rapidly progressive osteoarthritis have all been of a particular type, classified in osteoarthritic terms, KL -- these are KL3 and above.
重要的是要注意,患有快速進展性骨關節炎的患者都屬於特定類型,按骨關節炎術語 KL 分類——這些是 KL3 及以上。
So as we continue for patients with early osteoarthritis, the risk at this moment is really not viewed as significantly higher.
因此,當我們繼續治療早期骨關節炎患者時,目前的風險實際上並沒有被視為明顯更高。
And so when you look at -- and Pfizer and Lilly have done the same thing, when they've continue with their Phase III programs, they continuing with OA and mild OA, and severe OA patients have been excluded from the study.
所以當你看——輝瑞和禮來做了同樣的事情,當他們繼續他們的 III 期項目時,他們繼續 OA 和輕度 OA,並且嚴重的 OA 患者被排除在研究之外。
And that's what we plan to do.
這就是我們計劃要做的。
So firstly, in the patient selection we'll go with patients with lower degrees of OA.
因此,首先,在患者選擇中,我們將選擇骨關節炎程度較低的患者。
OA is a progressive illness over time but it's very slowly progressive, and obviously will have to be monitored.
OA 是一種隨著時間的推移而進行的疾病,但它的進展非常緩慢,顯然必須進行監測。
And then second thing, but there's a huge population of patients with early OA, and a KL less than 3 is very significant too.
然後是第二件事,但是有大量的早期 OA 患者,KL 小於 3 也非常重要。
These are very significant proportion of patients.
這些患者的比例非常大。
And then secondly, the dosage is important.
其次,劑量很重要。
And what we've seen when you start getting down to lower doses, and for us it's 3- and 6-milligram, there is no evidence for increase in OA of some of these severe population, of severe side effects in this population.
當你開始降低劑量時我們所看到的,對我們來說是 3 毫克和 6 毫克,沒有證據表明其中一些嚴重人群的 OA 增加,也沒有證據表明這些人群中有嚴重的副作用。
So the Phase III studies are going to have two important parameters, and this is already, this is going to be osteoarthritis of a milder degree, number one, number two, lower dose.
所以 III 期研究將有兩個重要的參數,這已經是,這將是較輕程度的骨關節炎,第一,第二,較低的劑量。
The patients that were seen in the rapidly progressive with chronic low back pain had severe osteoarthritis, KL greater than 3, and were getting 9-milligram IV, which is even higher than 9-milligram oral and 9 milligram sub-Q.
在快速進展的慢性腰痛中觀察到的患者患有嚴重的骨關節炎,KL 大於 3,並且正在接受 9 毫克靜脈注射,這甚至高於 9 毫克口服和 9 毫克亞 Q。
So we will be planning these studies appropriately, and patients with severe osteoarthritis won't be candidates in part of our clinical trials.
因此,我們將適當地規劃這些研究,患有嚴重骨關節炎的患者將不會成為我們臨床試驗的一部分。
Rob Koremans - President & CEO Global Specialty Medicines
Rob Koremans - President & CEO Global Specialty Medicines
And Ronny, maybe as part of the respi question, the development strategy we've chosen in the US was very different from Europe, right, where basically in Europe they tried to show and had to show bio equivalence which led to only being able launch the high dose.
羅尼,也許作為 respi 問題的一部分,我們在美國選擇的發展戰略與歐洲非常不同,對吧,基本上在歐洲,他們試圖展示並且必須展示生物等效性,這導致只能啟動高劑量。
In the US, we will have both doses.
在美國,我們將同時服用這兩種劑量。
We have a different development, and we will be able to cover, if we get the registration, the entire spectrum.
我們有不同的發展,如果我們獲得註冊,我們將能夠覆蓋整個範圍。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
So if I take the housekeeping, Ronny, obviously we're not giving the profitability of the Actavis business, but if you look at the slides that Eyal showed, the overall revenue prior to divestiture of the Actavis business was $943 million.
因此,如果我考慮家務管理,Ronny,顯然我們沒有給出 Actavis 業務的盈利能力,但如果你看看 Eyal 展示的幻燈片,剝離 Actavis 業務之前的總收入為 9.43 億美元。
We had roughly around $50 million from the Actavis business as a divested business, and the breakup would be roughly that there would be $530 million from the US and roughly $350 million from the rest of the world.
作為剝離的業務,我們從 Actavis 業務中獲得了大約 5000 萬美元,而分拆大約是美國將獲得 5.3 億美元,世界其他地區將獲得大約 3.5 億美元。
I think the divestiture is 50/50 Teva and Actavis overall.
我認為整體剝離是 Teva 和 Actavis 的 50/50。
So that's what's coming from Actavis.
這就是 Actavis 的成果。
We are very pleased with it, in terms of the total revenue.
就總收入而言,我們對此感到非常滿意。
In terms of the pricing pressure, I think we heard our customers talk a lot about increased competition between them.
就定價壓力而言,我想我們聽到我們的客戶談論了很多關於他們之間競爭加劇的問題。
And I think that's right, but that's for -- I don't think that is for the whole market, because ABC obviously has strong ties with Walgreens, and the remaining of their business they're competing for.
我認為這是對的,但那是為了——我不認為那是為了整個市場,因為 ABC 顯然與 Walgreens 有著密切的聯繫,以及他們正在競爭的剩餘業務。
The same applies obviously to Cardinal.
這同樣適用於 Cardinal。
They have strong ties to CVS.
他們與 CVS 有著密切的聯繫。
The rest of their business, they're competing with the rest.
他們的其餘業務,他們正在與其他公司競爭。
And McKesson has maybe a little bit more fluid business, but they have currently the Rite-Aid business, they just took over Wal-Mart, and they have a strong support for many of the other businesses.
McKesson 的業務可能更靈活一些,但他們目前擁有 Rite-Aid 業務,他們剛剛接管了沃爾瑪,並且為許多其他業務提供了強大的支持。
So I think there clearly is a competition, but it's for a relatively small part of the overall business.
所以我認為顯然存在競爭,但它只針對整個業務的一小部分。
Clearly, we are impacted by it, but we being the largest supplier I think what we can say is; with our pipeline, with our service level which we have increased year on year, I think we will be impacted.
顯然,我們受到了它的影響,但我們是最大的供應商,我認為我們可以說的是;隨著我們的管道,隨著我們逐年提高的服務水平,我認為我們會受到影響。
But we will be impacted to a lesser degree than any of the other players in the market due to the size and the strength of the business we have.
但由於我們擁有的業務規模和實力,我們受到的影響程度將低於市場上任何其他參與者。
So I, we notice it, we know of the competition of our customers, but at the end of the day, it's not a majority of the market.
所以我,我們注意到了,我們知道我們客戶的競爭,但歸根結底,它並不是市場的大部分。
It's a small portion of their overall business, where they're competing very fiercely at the moment.
這只是他們整體業務的一小部分,目前他們的競爭非常激烈。
Ronny Gal - Analyst
Ronny Gal - Analyst
Thank you.
謝謝你。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of 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 few.
我只有幾個。
Siggi, recognizing that you're not ready yet to give 2017 guidance, and listening to your commentary about first-to-file opportunities, et cetera, are you standing by your mid single-digit growth projection for the combined Teva/Allergan generic businesses?
Siggi,認識到你還沒有準備好提供 2017 年的指導,並聽取了你對首次申請機會等的評論,你是否堅持你對 Teva/Allergan 仿製藥合併業務的中等個位數增長預測?
And I only ask, because obviously, your standalone Teva business both in the US and total generics is way down.
我只問,因為很明顯,你在美國的獨立 Teva 業務和總仿製藥都在下降。
I can't really tell, and maybe you could help us to understand what the Actavis business is growing ex-divestitures?
我真的說不清楚,也許你可以幫助我們了解 Actavis 業務在剝離前的增長情況?
It looks like that's also trending below that 5%, so your 5% would require a monumental turnaround going forward.
它看起來也低於 5%,因此你的 5% 需要一個巨大的轉變才能向前發展。
I'm just wondering if you can comment on that?
我只是想知道你是否可以對此發表評論?
And then, I have a couple follow-ups for Eyal.
然後,我對 Eyal 進行了幾次跟進。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
So thanks, Jami.
所以謝謝,賈米。
As I said in my prepared remarks, I believe in the mid single-digit growth going forward.
正如我在準備好的發言中所說,我相信未來會出現中個位數的增長。
I don't know if we achieve that in 2017.
我不知道我們能否在 2017 年實現這一目標。
That will depend very heavily on how the launches hold up, but going forward, going over the next five years, I believe that the underlying business and the new products that we have pending, and that we believe this very, very strongly, Jami, we will be able to grow 5%.
這將在很大程度上取決於發布的情況,但展望未來,在接下來的五年裡,我相信我們正在等待的基礎業務和新產品,我們非常非常堅信這一點,Jami,我們將能夠增長 5%。
Will we do that in every quarter?
我們會在每個季度都這樣做嗎?
Of course, not.
當然不是。
Due to the variability of new product launches, you will have quarters where you might go down, and you will have quarters where you do better.
由於新產品發布的可變性,您將有可能表現不佳的季度,也有可能做得更好的季度。
Just remember first quarter and second quarter last year, where we had the 15% growth on the Teva generic business versus the year before.
請記住去年第一季度和第二季度,我們的 Teva 仿製藥業務與去年同期相比增長了 15%。
So we have the ups and downs, but when you take the long-term view, which you absolutely have to do when you look at the generic business, it's not nearly as stable as a specialty business.
所以我們有起起落落,但是當你從長遠來看時,當你看通用業務時你絕對必須這樣做,它遠不如專業業務穩定。
But when you take the long-term view, when you take the five year view of the business, I'm absolutely convinced with what we have in place, we have a 5% to mid single-digit growth in the overall business.
但是,當你從長遠來看,當你從五年的角度來看業務時,我絕對相信我們已經到位,我們的整體業務有 5% 到中個位數的增長。
But I really can't tell you from quarter to quarter, that we will always do 5%, because it's simply the volatility in the business doesn't allow you to do that.
但我真的不能每個季度都告訴你,我們總是會做 5%,因為這只是業務的波動性不允許你這樣做。
Jami Rubin - Analyst
Jami Rubin - Analyst
I guess, I'm just asking because the guidance assumes 5% growth on an annual basis, I recognize we can't project quarter by quarter, so it sounds like you're sticking by that.
我想,我只是在問,因為指導假設每年增長 5%,我知道我們不能逐季度預測,所以聽起來你堅持這一點。
Eyal, just a couple questions for you.
Eyal,只問你幾個問題。
How much -- I mean, the OTC business is very strong, up 40%.
多少——我的意思是,場外交易業務非常強勁,增長了 40%。
What was the contribution from Venezuela, and how much of that can we expect going forward, just given that other companies have written down that business?
委內瑞拉的貢獻是什麼,考慮到其他公司已經減記該業務,我們可以期待其中有多少?
And then also what is the $155 million in other COGS related adjustments that helped your gross margin this quarter?
然後還有 1.55 億美元的其他 COGS 相關調整對本季度的毛利率有所幫助?
Didn't notice that item in 2015, and just wondering what this is?
2015 年沒注意到那個項目,只是想知道這是什麼?
Thanks very much.
非常感謝。
Eyal Desheh - CFO
Eyal Desheh - CFO
Yes.
是的。
All right, thank you.
好噠。謝謝你們。
I'll start from the last thing, other cost adjustments, it's a long list of items, no one that stands out, so if we could take it offline, I can run you through the list.
我將從最後一件事開始,其他成本調整,這是一長串項目,沒有一個突出,所以如果我們可以將其脫機,我可以讓您瀏覽一下列表。
It's not very material.
這不是很重要。
Regarding Venezuela, I think I preempted that in one of my earlier answers.
關於委內瑞拉,我想我在我之前的一個回答中搶占了這一點。
But just to repeat, sales in Venezuela, from Venezuela to this quarter were about $280 million, including the generic product, the Rx product, and the OTC operating profit was lower than in Q2, which was also lower than in Q1, represents about $0.02, or just under $0.02 per share to our overall EPS for the quarter.
但重複一下,從委內瑞拉到本季度,委內瑞拉的銷售額約為 2.8 億美元,包括仿製藥、Rx 產品,OTC 營業利潤低於第二季度,也低於第一季度,約 0.02 美元,或略低於我們本季度整體每股收益的每股收益 0.02 美元。
And there's no change in the accounting treatment and the exchange rate that we used since the beginning of the year.
自年初以來我們使用的會計處理和匯率沒有變化。
Jami Rubin - Analyst
Jami Rubin - Analyst
Thank you.
謝謝你。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Chris Schott.
你的下一個問題來自 Chris Schott。
Chris Schott - Analyst
Chris Schott - Analyst
Great, thanks very much.
太好了,非常感謝。
Just to make -- we talked a lot about this generic pricing environment.
只是為了製作 - 我們談論了很多關於這種通用定價環境的問題。
But you obviously saw a more difficult pricing dynamic this quarter with these 60 products.
但是你顯然看到本季度這 60 種產品的定價動態更加困難。
But a number of your smaller competitors also seemed to be really struggling throughout this year.
但是你的一些較小的競爭對手似乎在今年也確實在苦苦掙扎。
And it seems like each subsequent quarter this year, we're seeing a different part of the generic market under pressure.
似乎今年接下來的每個季度,我們都看到仿製藥市場的不同部分面臨壓力。
So I guess, I'm just trying to get how you separate out normal quarter to quarter volatility of generics, versus an overall more challenging generic pricing environment that could persist for an extended period of time?
所以我想,我只是想了解如何區分仿製藥的正常季度波動與可能持續較長時間的整體更具挑戰性的仿製藥定價環境?
Because anyone that look at the industry as a whole, it feels like this a broader issue than one-off market disruptions.
因為從整個行業來看,任何人都會覺得這是一個比一次性市場中斷更廣泛的問題。
So any color you have on that, I know we've talked about some of this before, but any color would be great?
所以你有任何顏色,我知道我們之前已經討論過其中的一些,但是任何顏色都會很棒?
And the second question I had, is just with the stock in the $40 range, where does share repo factor into your capital allocation plans?
我的第二個問題是,股票在 40 美元範圍內,股票回購在你的資本配置計劃中有什麼影響?
And do you have the ability or the capacity to look at a share repo, given the leverage position right now?
鑑於現在的槓桿地位,你是否有能力或有能力查看股票回購?
Thanks very much.
非常感謝。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
So Chris, a good question.
所以克里斯,一個很好的問題。
I think Teva is ideally positioned probably to take the temperature of the pricing in the US.
我認為 Teva 處於理想的位置,可能會影響美國的定價。
So let me maybe explain how we think about it.
那麼讓我解釋一下我們是如何考慮的。
We market between 300 and 400 products on the market, when the smaller players are maybe dealing with 30 to 60 products.
我們在市場上銷售 300 到 400 種產品,而較小的參與者可能只銷售 30 到 60 種產品。
So any impact on one category, on one therapeutic area, on even their biggest product has significant impact on their Company, and the price erosion.
因此,對一個類別、一個治療領域、甚至他們最大的產品的任何影響都會對他們的公司產生重大影響,並導致價格下跌。
Where even an impact on maybe 50 to 60 of our key products doesn't move the needle that much, in terms of price erosion in the quarter, even though obviously, we felt the extra 2% clearly in the business.
就本季度的價格下跌而言,即使對我們 50 到 60 種主要產品的影響也不會產生太大影響,儘管很明顯,我們在業務中明顯感受到額外的 2%。
But it shows the strength and the benefit of being large in the market.
但它顯示了在市場上做大的實力和好處。
We have a good service level.
我們有很好的服務水平。
I think our operational colleagues here have done better than ever before, in being ready for the integration.
我認為我們這裡的運營同事在為整合做好準備方面比以往任何時候都做得更好。
We have serviced our customers well.
我們為客戶提供了很好的服務。
We're offering all these products to the market.
我們向市場提供所有這些產品。
How I think about it is, I think about basically transition products, products where we are losing exclusivity, which always will hurt us.
我的想法是,我考慮的基本上是過渡產品,我們正在失去排他性的產品,這總是會傷害我們。
And that was the comparison I talked to Umer about as in terms of esomeprazole, Xeloda, aripiprazole, et cetera.
這就是我與 Umer 談到的關於埃索美拉唑、希羅達、阿立哌唑等的比較。
Those are the transition products you will always see a little bit higher price erosion on these products.
這些是過渡產品,您總是會看到這些產品的價格下降一點點。
Then, obviously we could identify the transition product that we have to divest, the duplicates to our competitors, we saw more pricing pressure there.
然後,顯然我們可以確定我們必須剝離的過渡產品,我們的競爭對手的重複產品,我們在那裡看到了更多的定價壓力。
And then, the base business, is very big base business, where it's the best [rating] I think in the overall pricing environment in the US.
然後,基礎業務是非常大的基礎業務,我認為它是美國整體定價環境中最好的[評級]。
So maybe we have to take a view of what we will see in 2017, but where I sit here today, experiencing the market, there hasn't again been any fundamental change.
所以也許我們必須看看我們將在 2017 年看到什麼,但我今天坐在這裡,體驗市場,並沒有再次發生任何根本性的變化。
Yes, our customers are talking about more fierce competition, but as I mentioned before, it's for a limited part of the market.
是的,我們的客戶正在談論更激烈的競爭,但正如我之前提到的,這是針對市場的有限部分。
And then on top of that, I think we are servicing our customers significantly better with Anda by our side, Anda being the fourth largest distributor of generics, which will help us to service the customers better in the long run as a plan.
然後最重要的是,我認為我們在 Anda 的幫助下為我們的客戶提供了更好的服務,Anda 是第四大仿製藥分銷商,從長遠來看,這將有助於我們更好地為客戶提供服務。
But the bottom line, Chris, there hasn't been a significant change in the business.
但最重要的是,克里斯,業務沒有發生重大變化。
But we will take a view on that, of course, before we guide for 2017.
但在我們為 2017 年提供指導之前,我們當然會對此發表看法。
Erez Vigodman - CEO
Erez Vigodman - CEO
On capital allocation, Chris I said it before, just reiterating what I've already said, our focus now is on unlocking the value from the integration, from our generic business, realizing the value from our specialty pipeline, with strong focus on internal programs, complementing core TAs with the deals which are tuck-in deals, not significant ones.
關於資本配置,克里斯我之前說過,只是重申我已經說過的話,我們現在的重點是從整合中釋放價值,從我們的仿製藥業務中釋放價值,從我們的專業管道中實現價值,重點放在內部項目上, 補充核心 TAs 的交易,這些交易是臨時交易,而不是重要交易。
And then focusing strongly on paying down debt, and with a quest to reach the level of 3.5 times debt to EBITDA as quickly as possible.
然後將重點放在償還債務上,並爭取盡快達到債務與 EBITDA 的 3.5 倍的水平。
And before we do that, we'll not consider other potential capital allocation initiatives.
在我們這樣做之前,我們不會考慮其他潛在的資本配置計劃。
Chris Schott - Analyst
Chris Schott - Analyst
Great.
偉大的。
Thank you.
謝謝你。
Operator
Operator
Thank you, we have no further questions on the phone.
謝謝,我們在電話中沒有其他問題。
I'll now hand the call over to Erez Vigodman.
我現在將電話轉給 Erez Vigodman。
Please go ahead.
請繼續。
Erez Vigodman - CEO
Erez Vigodman - CEO
So on behalf of the entire team, I would like to thank you for participating in today's call.
因此,我代表整個團隊感謝您參加今天的電話會議。
We look forward to speaking with you, seeing many of you in the coming months.
我們期待與您交談,並在接下來的幾個月中與您見面。
Thank you again.
再次感謝你。
Operator
Operator
Thank you, that does conclude our conference for today.
謝謝,今天的會議到此結束。
Thank you all for participating, and you may now all disconnect.
感謝大家的參與,你們現在可以斷開連接了。