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Operator
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Teva Pharmaceutical Industries' second-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 年第二季度業績電話會議。
(Operator Instructions)
(操作員說明)
I must advise you this conference is being recorded today, Thursday, the 4th of August, 2016. I would now like to hand the conference over to your first speaker today, Kevin Mannix, Senior Vice President and Investor Relations. Thank you, and please go ahead, sir.
我必須告訴你,今天,也就是 2016 年 8 月 4 日,星期四,這次會議正在錄製。我現在想把會議交給今天的第一位發言人,高級副總裁兼投資者關係部 Kevin Mannix。謝謝,請繼續,先生。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Thank you, Rose. Good morning and good afternoon, everyone. Thank you for joining us today to discuss Teva's second-quarter 2016 financial results. 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. Michael Hayden, Head of R&D, Chief Scientific Officer; Dr. Carlo De Notaristefani, President and CEO, Global Operations; David Stark, Senior Vice President, General Counsel, Global Markets and GSM; Mike McClellan, Senior Vice President, CFO, Global Specialty Medicines; Mike Derkacz, Senior Vice President and Head of Global CNS; and Sven Dethlefs, Head of Global Respiratory Medicines.
謝謝你,羅斯。大家早上好,下午好。感謝您今天加入我們討論 Teva 2016 年第二季度的財務業績。今天與我通話的有: Erez Vigodman,首席執行官; Eyal Desheh,首席財務官;全球仿製藥公司總裁兼首席執行官 Siggi Olafsson; Michael Hayden 博士,研發主管、首席科學官;全球運營總裁兼首席執行官 Carlo De Notaristefani 博士;全球市場和 GSM 高級副總裁兼總法律顧問 David Stark;全球特種藥物高級副總裁兼首席財務官 Mike McClellan; Mike Derkacz,高級副總裁兼全球 CNS 負責人;和全球呼吸內科負責人 Sven Dethlefs。
We will start the call with presentations from Erez and Eyal, before opening the call up for questions and answers. A copy of today's press release and slides can be found on our website, tevapharm.com, and under the Investor Relations section with the Teva Investor Relations app.
我們將以 Erez 和 Eyal 的演講開始電話會議,然後再開始電話問答。今天的新聞稿和幻燈片的副本可以在我們的網站 tevapharm.com 上找到,也可以在 Teva 投資者關係應用程序的投資者關係部分下找到。
During this call, we will be making forward-looking statements which are predictions, projections, and other statements about future events. These estimates reflect management's current expectations for Teva's performance. Actual results may vary, whether as a result of exchange rate differences, market conditions, or other factors.
在此次電話會議中,我們將做出前瞻性陳述,即預測、預測和關於未來事件的其他陳述。這些估計反映了管理層目前對 Teva 業績的預期。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. 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 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.
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。 Teva 提供的非 GAAP 數據是 Teva 管理層和董事會用來評估公司經營業績、與公司工作計劃和預算進行比較並最終評估管理層業績的結果。 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. Erez?
有了這個,我現在將把電話轉給我們的首席執行官 Erez Vigodman。埃雷茲?
Erez Vigodman - CEO
Erez Vigodman - CEO
Thank you, Kevin. Good morning, good afternoon, and thank you for joining us today. 2016 is a transition year for us. We are focused on fully delivering on our short-term operational and financial goals, and at the same time moving ahead with our longer term strategic moves.
謝謝你,凱文。早上好,下午好,感謝您今天加入我們。 2016年對我們來說是一個過渡年。我們專注於全面實現我們的短期運營和財務目標,同時推進我們的長期戰略舉措。
During the first half of the year, we closed the Actavis Generics deal, announced the acquisition of Anda, and completed a very successful global equity and debt (inaudible)financing. We closed the JV with Takeda in Japan, and the acquisition of Rimsa in Mexico. We are making progress in our specialty franchise, and we are able to successfully manage the life cycle of Treanda. And lastly, we continued the transformation and optimization of our operational network, and the deployment of cost controls and efficiency measures.
今年上半年,我們完成了對 Actavis Generics 的交易,宣布收購 Anda,並完成了非常成功的全球股權和債務(聽不清)融資。我們在日本關閉了與武田的合資企業,並在墨西哥收購了 Rimsa。我們在專業特許經營方面取得進展,我們能夠成功管理 Treanda 的生命週期。最後,我們繼續對我們的運營網絡進行改造和優化,並部署成本控制和效率措施。
In the first six months of 2016, we were able to generate very similar results to the strong comparable first six months of 2016 without major new generic launches in the US, versus the exclusive Aripiprazole, Esomeprazole and Budesonide we had in 2015.
在 2016 年前六個月,我們能夠產生與 2016 年前六個月強勁可比的結果非常相似,而沒有在美國推出主要的新仿製藥,而我們在 2015 年擁有獨家的阿立哌唑、埃索美拉唑和布地奈德。
Non-GAAP EPS for the first six months of 2016 is $2.45, based on share count of 981 million shares. Adjusted to exclude the impact of the December 2015 equity offering, non-GAAP EPS in 2016 is similar to that in the first six months of 2015. Eyal Desheh will cover Q2 in detail.
2016 年前六個月的非美國通用會計準則每股收益為 2.45 美元,基於 9.81 億股股票。經調整以排除 2015 年 12 月股票發行的影響,2016 年非 GAAP 每股收益與 2015 年前六個月相似。Eyal Desheh 將詳細介紹第二季度。
Slide 6 provides you with a revenue bridge and tells the story of the first six months of the year. The loss of exclusivities of generic Aripiprazole, Esomeprazole and Budesonide were more than offset by the growth of our generic and OTC business in 2016, without having major new launches in the US, and by the growth of our specialty business versus 2015. Our global generics business generated 26.8% operating margin in first six months of the year.
幻燈片 6 為您提供了一個收入橋樑,並講述了今年前六個月的故事。仿製藥阿立哌唑、埃索美拉唑和布地奈德的專營權損失被我們 2016 年仿製藥和非處方藥業務的增長(沒有在美國推出重大新藥)以及我們的特種藥物業務與 2015 年相比的增長所抵消。我們的全球仿製藥該業務在今年前六個月產生了 26.8% 的營業利潤率。
Two days ago, we were very pleased to have report the closing of our deal to acquire the Actavis Generics business. The generics industry is one of the most attractive industries in the world in terms of growth rate, profitability, return to investors, and contribution to healthcare system and societies in the US and across the globe. The transaction between Teva and Actavis Generics transformed the generics space by combining two of the industry's best generic companies.
兩天前,我們非常高興地報告我們完成了收購阿特維斯仿製藥業務的交易。就增長率、盈利能力、投資者回報以及對美國和全球醫療體系和社會的貢獻而言,仿製藥行業是世界上最具吸引力的行業之一。 Teva 和 Actavis Generics 之間的交易通過合併業內最好的兩家仿製藥公司改變了仿製藥領域。
It cements and broadens our R&D capabilities and highly complements our product pipeline, product portfolio, geographical footprint and operational network. It enhances Teva's leadership in an evolving customer landscape and massive consolidation across our customer base. Finally, it strongly reinforces our strategy, opening a new set of possibilities for us in generics and specialty.
它鞏固並擴大了我們的研發能力,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。它增強了 Teva 在不斷變化的客戶環境和我們客戶群的大規模整合方面的領導地位。最後,它有力地加強了我們的戰略,為我們在仿製藥和專業領域開闢了一系列新的可能性。
Financially, the transaction yields very compelling economics. It is highly synergistic with $1.4 billion in operational and tax synergies achievable by the end of 2019. It is significantly accretive to non-GAAP EPS with 14% accretion in 2017, and 19% accretion in 2019, and is expected to generate 9.3% ROIC by the end of 2019. The combined Company will generate more than $25 billion of free cash flow from the beginning of August 2016 until the end of 2019.
在財務上,該交易產生了非常引人注目的經濟效益。它具有高度協同作用,到 2019 年底可實現 14 億美元的運營和稅收協同效應。它顯著增加了非 GAAP 每股收益,2017 年增長 14%,2019 年增長 19%,預計將產生 9.3% 的 ROIC到 2019 年底。從 2016 年 8 月開始到 2019 年底,合併後的公司將產生超過 250 億美元的自由現金流。
On July 21, we completed a very successful global bond offering, with total net order book of $100 billion, raising $20.4 billion in three currencies across 12 [trenches], ranging from 2 to 30 years with average duration of 8.65 years, one year longer than our original plan, and blended interest rate of 2.17%. The total cost of our borrowing for the deal including the term loan is 2.12%, and including the cost of the bond offering and cost of hedging 2.32%, versus 2.96% that we assumed in the financial outlook model we shared with the street before the bond offering, and 3.5% when we announced the Actavis Generics deal.
7 月 21 日,我們完成了一次非常成功的全球債券發行,淨訂單總額為 1000 億美元,在 12 個 [渠道] 中以三種貨幣籌集了 204 億美元,期限從 2 年到 30 年不等,平均期限為 8.65 年,延長了一年比我們原來的計劃,混合利率為 2.17%。包括定期貸款在內,我們為這筆交易借款的總成本為 2.12%,包括債券發行成本和對沖成本 2.32%,而我們在 2019 年之前與華爾街分享的財務前景模型中假設的為 2.96%債券發行,以及我們宣布 Actavis Generics 交易時的 3.5%。
Anda is one of the leading distributors in the US of generic, brand, specialty and over-the-counter pharmaceutical products, and the fourth largest distributer of generic pharmaceuticals in the US for more than 350 manufacturers to more than 60,000 retail independent and chain pharmacies, nursing homes, mail order pharmacies, hospitals, clinics, and physicians offices across the US. Anda ships to more than 85% of the pharmacies in the United States, and it is the premier distributer of new-to-market launches to the chain.
Anda 是美國仿製藥、品牌藥、專業藥和非處方藥產品的領先分銷商之一,也是美國第四大仿製藥分銷商,為 350 多家製造商和 60,000 多家零售獨立藥店和連鎖藥店提供服務、療養院、郵購藥店、醫院、診所和醫生辦公室。 Anda 向美國 85% 以上的藥店發貨,它是該連鎖店新上市產品的主要分銷商。
Anda is a natural fit into Teva's business model, enhancing the offerings that Teva can provide, and improving patient access to generic medicine in the United States. Financially, the Anda transaction we announced yesterday yields compelling economy.
Anda 非常適合 Teva 的商業模式,增強了 Teva 可以提供的產品,並改善了美國患者獲得仿製藥的機會。在財務上,我們昨天宣布的安達交易產生了引人注目的經濟效益。
Post the close of the Actavis Generics deal, and with everything we have accomplished as a Company since the beginning of 2014, we have been creating a new Teva, with strong foundation, significantly enhanced financial profile, more diversified revenue sources and profit streams, promising specialty pipeline backed by strong product development engines in both generics and specialty. This is a platform that will generate multi-year top-line and bottom-line growth as well as significant cash flow.
在 Actavis Generics 交易結束後,憑藉我們自 2014 年初以來作為一家公司所取得的一切成就,我們一直在創建一個新的 Teva,它擁有堅實的基礎、顯著改善的財務狀況、更多元化的收入來源和利潤流,前景廣闊由強大的仿製藥和專業產品開發引擎支持的專業管道。這是一個將產生多年收入和利潤增長以及大量現金流的平台。
There are many moving parts on our patent estate on Copaxone 40-milligram, and we thought it would be useful to describe to you the major pieces. First, the traditional court process under Paragraph IV of Hatch Waxman that we are all familiar with. We have five patents that are listed in the Orange Book. Orange Book listings are important because if we prevail in the court process, we are entitled to an automatic injunction.
在我們關於 Copaxone 40 毫克的專利資產中有許多活動部分,我們認為向您描述主要部分會很有用。首先,我們都熟悉的 Hatch Waxman 案第 IV 段下的傳統法庭程序。我們有五項專利被列入橙皮書。橙皮書列表很重要,因為如果我們在法庭程序中勝訴,我們有權獲得自動禁令。
Trial on the first four patents is scheduled to commence next month on September 26 in front of Judge Sleet in the District of Delaware. During the trial, the judge presumes the patent is valid, and the plaintiffs have the burden of showing otherwise by clear and convincing evidence. We have not yet brought any action on our fifth patent.
前四項專利的審判定於下個月 9 月 26 日在特拉華州地區法官 Sleet 面前開始。在審理過程中,法官推定專利有效,原告有責任以明確和令人信服的證據證明並非如此。我們還沒有對我們的第五項專利提起任何訴訟。
Judge Sleet has a lot of experience in pharmaceutical patent matters, and we expect a decision sometime in Q1 of next year. Appeals of lower court decisions are heard by the federal circuit, and generally take about a year, though en banc review can take longer. And as we all know, it is not unheard of for the Supreme Court to become interested these matters. There is a separate, but related process, where our patents are being challenged in the patent office which is relatively new under the America Invents Act, so I will get into a little more detail on this.
Sleet 法官在醫藥專利事務方面擁有豐富的經驗,我們預計明年第一季度的某個時候會做出決定。對下級法院判決的上訴由聯邦巡迴法院審理,通常需要一年左右的時間,但全體法官的複審可能需要更長時間。眾所周知,最高法院對這些問題感興趣並非聞所未聞。有一個單獨但相關的流程,我們的專利在美國發明法案下相對較新的專利局受到挑戰,因此我將對此進行更詳細的介紹。
First off, Mylan and Amneal have challenged our first three patents in an inter partes review known as an IPR. Back in May, we participated in a hearing in front of a three-judge panel at the patent office, i.e. the Patent and Trademark Appeals Board, where we defended the validity of these patents, and we expect a decision at any time, but no later than August 25.
首先,Mylan 和 Amneal 在稱為 IPR 的雙方復審中對我們的前三項專利提出了質疑。早在 5 月份,我們就參加了專利局三名法官組成的聽證會,即專利和商標上訴委員會,我們為這些專利的有效性辯護,我們期待隨時做出決定,但沒有晚於 8 月 25 日。
There is also a request for the patent office to commence a post-grant review or PGR on the fourth patent. The patent office has until August 24 to decide whether to commence this proceeding, and if it is declined, we expect an IPR will be sought on that one as well.
還要求專利局開始對第四項專利進行授權後審查或 PGR。專利局必須在 8 月 24 日之前決定是否啟動此程序,如果被拒絕,我們預計也將對該程序尋求知識產權。
Generally speaking, the patent office has around six months from the request to decide whether to commence a proceeding, and then the process to decision takes another year from there. Each of the IPR and PGR decisions can be appealed by either side to the Federal Circuit, and although there is less experience here, that process should take about a year. Accordingly, both the Paragraph IV lawsuit and the IPR/PGR proceedings will need to be decided by the Federal Circuit.
一般來說,專利局從請求開始大約有六個月的時間來決定是否啟動程序,然後從那裡到決定的過程又需要一年的時間。任何一方都可以就 IPR 和 PGR 決定向聯邦巡迴上訴法院提出上訴,儘管這裡的經驗較少,但該過程大約需要一年時間。因此,第 IV 段訴訟和 IPR/PGR 訴訟都需要由聯邦巡迴法院決定。
These patent office proceedings are cancellation proceedings, which mean that they seek to have the patent revoked at the patent office. This would only occur, if at all, after the appeals process is exhausted. One more thing to look for, it is common for the Appeals Board to cancel some claims at issue, but not others. In the event that the patent office does so in this case, we would view that very favorably for Teva, because the claims are independent and expire in 2030.
這些專利局程序是取消程序,這意味著他們尋求在專利局撤銷專利。如果有的話,這只會發生在上訴程序用盡之後。還有一件事需要注意,上訴委員會通常會取消一些有爭議的索賠,但不會取消其他索賠。如果專利局在這種情況下這樣做,我們認為這對 Teva 非常有利,因為權利要求是獨立的並且將於 2030 年到期。
Also in the event that we prevail on certain claims at the IPR, Mylan and Amneal would be prohibited for making these arguments in the Paragraph IV proceeding. And even, in the event that we lose all the claims in the IPR in August 2016, as far as the patent office is concerned, we still have the fourth and the fifth patents. And in addition to this, Judge Sleet is not bound by the IPR decision, and can reach a different conclusion. So finally to conclude, any generic launch prior to a final not-appealable court ruling on all five patents which is not expected before the second-half 2018, would be at risk.
此外,如果我們在 IPR 的某些主張上勝訴,Mylan 和 Amneal 將被禁止在第 IV 段程序中提出這些論點。甚至,如果我們在2016年8月失去了所有的IPR權利要求,就專利局而言,我們還有第四和第五項專利。除此之外,Sleet 法官不受 IPR 決定的約束,可以得出不同的結論。所以最後得出結論,在 2018 年下半年之前預計不會對所有五項專利作出最終不可上訴的法院裁決之前,任何仿製藥的發布都將面臨風險。
Moving on to our specialty pipeline. We continue to make progress focusing on our four core therapeutic areas. These are the upcoming key milestones in the second half of 2016, in movement disorders and neuro-degeneration diseases, SD-809 for Huntington Disease, full response to the CRL we received from the FDA is targeted for the end of September 2016, with up to six months for FDA to review, and target approval by the end of March 2017.
繼續我們的專業管道。我們繼續在我們的四個核心治療領域取得進展。這些是 2016 年下半年即將到來的關鍵里程碑,運動障礙和神經退行性疾病,亨廷頓病的 SD-809,我們從 FDA 收到的 CRL 的全面響應目標是在 2016 年 9 月底,最多FDA 審查時間為 6 個月,目標是在 2017 年 3 月底前獲得批准。
SD-809 for Tardive Dyskinesia, we expect Phase III clinical results. Pridopidine for Huntington Disease, we expect Phase II clinical study results. In pain, we expect approval in the US for Vantrela Extended Release our Hydrocodone product, and Phase III clinical study results for immediate release Hydrocodone.
SD-809用於遲發性運動障礙,我們期待III期臨床結果。普利多匹定治療亨廷頓病,期待二期臨床研究結果。在痛苦中,我們期待美國批准 Vantrela 緩釋我們的氫可酮產品,以及速釋氫可酮的 III 期臨床研究結果。
In respiratory, we expect two approvals in Europe for Reslizumab and for FS Spiromax. In migraine and headaches, we continue to be very excited about the prospects we see in the clinical development of TEV-84125 in episodic migraine, chronic migraine and cluster headaches. Recruitment for the Phase III clinical trials in the episodic and chronic headache programs is going very well, exceeding our earlier expectations.
在呼吸系統方面,我們預計 Reslizumab 和 FS Spiromax 將在歐洲獲得兩項批准。在偏頭痛和頭痛方面,我們繼續對 TEV-84125 在發作性偏頭痛、慢性偏頭痛和叢集性頭痛的臨床開發中看到的前景感到非常興奮。發作性和慢性頭痛項目的 III 期臨床試驗招募進展順利,超出了我們早先的預期。
And finally, these are our key priorities for the remainder of 2016. We'll put strong focus on the integration of Actavis Generics, and the extraction of synergies while we continue to deliver on our operational and financial targets. In addition, we'll put strong focus on achieving all 2016 key milestones in our specialty pipeline.
最後,這些是我們 2016 年剩餘時間的主要優先事項。我們將重點關注 Actavis Generics 的整合和協同效應的提取,同時我們繼續實現我們的運營和財務目標。此外,我們將重點關注在我們的專業管道中實現所有 2016 年的關鍵里程碑。
On the business-development front, we are targeting attractive pipeline and specialty assets in our core TAs, biosimilar assets and strategic platform in key growth markets. And lastly, we plan to provide you with a few business updates in the coming months. In September, we plan to hold combined global generics medicines business overview. Before the end of the year, we plan to hold a specialty medicine R&D Day. And in conjunction with 2016 full-year results, we plan to provide in early 2017, detailed 2017 financial outlook.
在業務發展方面,我們的目標是在我們的核心 TA、生物仿製藥資產和主要增長市場的戰略平台中提供有吸引力的管道和專業資產。最後,我們計劃在未來幾個月為您提供一些業務更新。 9月,我們計劃舉行聯合全球仿製藥業務概覽。今年年底前,我們計劃舉辦特色藥物研發日。結合 2016 年全年業績,我們計劃在 2017 年初提供詳細的 2017 年財務展望。
Thank you. And I would like to turn the call over to Eyal.
謝謝你。我想把電話轉給 Eyal。
Eyal Desheh - CFO
Eyal Desheh - CFO
Thank you, Erez. Good morning and good afternoon, everyone. Following a busy week of closing one major deal and signing on another one, I am pleased to review the financial results of the second quarter of 2016.
謝謝你,埃雷茲。大家早上好,下午好。在完成一項重大交易並簽署另一項交易的忙碌一周之後,我很高興回顧 2016 年第二季度的財務業績。
Revenues and non-GAAP profit came above our updated guidance, with over $5 billion in sales and $1.25 in earnings per share. On an apples-to-apples comparison, adjusting for the number of shares we raised last December, earnings per share was $1.43, same as in the second quarter in 2015. Our GAAP net income and earnings per share this quarter were lower than last year. This is due to expenses related to the voluntary withdrawal of Zecuity from the market, and the termination of our involvement in the development of Revascor. These two events amounted to $546 million of total adjustment.
收入和非 GAAP 利潤高於我們最新的指引,銷售額超過 50 億美元,每股收益 1.25 美元。在同類比較中,根據我們去年 12 月籌集的股票數量進行調整後,每股收益為 1.43 美元,與 2015 年第二季度相同。本季度我們的 GAAP 淨收入和每股收益低於去年.這是由於與 Zecuity 自願退出市場以及我們終止參與 Revascor 開發相關的費用。這兩個事件的總調整額為 5.46 億美元。
During the past four quarters, we generated over $5 billion in cash flow from operation. Cash flow this quarter was light, due to large cash tax payment, which were $500 million higher compared to Q1 this year.
在過去四個季度中,我們從運營中產生了超過 50 億美元的現金流。本季度現金流清淡,原因是支付了大量現金稅款,與今年第一季度相比增加了 5 億美元。
On our liquidity trends, liquidity ratios continued to be strong this quarter. However, following the Actavis closing early this week, our total debt increased by approximately $25 million. On EBITDA, we continued to generate strong EBITDA trends of $1.6 billion to $1.7 billion this quarter, and ended at $1.7 billion which is one of the highest in recent quarters.
根據我們的流動性趨勢,本季度流動性比率繼續保持強勁。然而,在本週早些時候關閉 Actavis 之後,我們的總債務增加了大約 2500 萬美元。在 EBITDA 方面,我們本季度繼續產生 16 億至 17 億美元的強勁 EBITDA 趨勢,最終達到 17 億美元,這是最近幾個季度的最高水平之一。
Now let's take a look at the results of the business this quarter. Exchange rates reduced revenues by $141 million compared to Q2 2015. Revenues of our US generics business was impacted by competition to our Aripiprazole, Esomeprazole, and Budesonide which were the major drivers of our generic business in the US in the second quarter last year. This was compensated by the performance of our global generic and OTC business, strong sales of Copaxone, and our specialty-product portfolio.
現在讓我們來看看本季度的業務結果。與 2015 年第二季度相比,匯率使收入減少了 1.41 億美元。我們美國仿製藥業務的收入受到與阿立哌唑、埃索美拉唑和布地奈德的競爭的影響,這些競爭是我們去年第二季度在美國仿製藥業務的主要推動力。我們的全球仿製藥和 OTC 業務的表現、Copaxone 的強勁銷售以及我們的專業產品組合彌補了這一點。
When we look at revenue distribution by region, US was down, and accounted for 53% of total revenues. Europe and the rest of the world were up, and accounted for 25% and 22% of total sales, respectively. Revenues by business line showed $170 million decline in global generics, and (inaudible) growth coming from Copaxone, specialty products and our OTC business.
當我們按地區查看收入分配時,美國有所下降,佔總收入的 53%。歐洲和世界其他地區有所增長,分別佔總銷售額的 25% 和 22%。按業務線劃分的收入顯示,全球仿製藥下降了 1.7 億美元,而(聽不清)來自 Copaxone、特種產品和我們的 OTC 業務的增長。
Operating profit for the quarter, which was similar to last year were influenced by the decline of our Aripiprazole, Esomeprazole, and Budesonide due to competition. While the rest of the global generic business improved nicely but not enough yet to compensate for the entire decline, Copaxone and specialty business generated $120 million improvement of operating profit over last year, and compensated for that.
本季度的營業利潤與去年相似,這是由於我們的阿立哌唑、埃索美拉唑和布地奈德因競爭而下降。雖然全球仿製藥業務的其餘部分有所改善,但仍不足以彌補全部下滑,但 Copaxone 和特種業務的營業利潤比去年增加了 1.2 億美元,並彌補了這一點。
So our global-generic business accounted for 33% of profit contribution this quarter, Copaxone was 49%, and specialty products 17%. Despite the year-over-year decline in major generic products, profit margins stayed healthy due to COGS reduction, and more profitable product mix. Copaxone continued its strong performance with exceptional sales of over $1.1 billion this quarter. Script level remains flat over the past four quarters.
因此,我們的全球通用業務佔本季度利潤貢獻的 33%,Copaxone 為 49%,特殊產品為 17%。儘管主要仿製藥同比下降,但由於銷貨成本下降和利潤更高的產品組合,利潤率保持健康。 Copaxone 繼續保持強勁表現,本季度銷售額超過 11 億美元。腳本水平在過去四個季度保持平穩。
Now let's look at the numbers for the first half of 2016. First half of 2016 revenues and non-GAAP profits were similar to the first half of 2015, while our GAAP net income was down $100 million due to the Q2 2016 impairment that I reported earlier. For the first six months, generics were down and accounted for 45% of total revenues, while Copaxone and specialty products were 23% and 22%, respectively.
現在讓我們看看 2016 年上半年的數據。2016 年上半年的收入和非 GAAP 利潤與 2015 年上半年相似,而由於我報告的 2016 年第二季度減值,我們的 GAAP 淨收入下降了 1 億美元更早。前六個月,仿製藥下降並佔總收入的 45%,而 Copaxone 和特殊產品分別為 23% 和 22%。
Looking at profit contribution by lines of business, generic contributed 32% of our total profit contribution for the first six months of this year. Copaxone was 47%, and our specialty product contributed 19% of total contribution.
從業務線的利潤貢獻來看,仿製藥貢獻了我們今年前六個月總利潤貢獻的 32%。 Copaxone 佔 47%,我們的特色產品佔總貢獻的 19%。
Dividend. So dividend payments for Q2 as approved and declared by our Board remain unchanged at $0.34 a regular share third quarter.
股利。因此,董事會批准和宣布的第二季度股息支付保持不變,第三季度普通股每股 0.34 美元。
I would like to talk about our financial outlook. So I'd like to reiterate the 2016 financial outlook which we provided just a few weeks ago, of revenues of $22 billion to $22.5 billion and non-GAAP earnings per share at $5.20 to $5.40. The strong non-GAAP EPS which we generated in Q2, are included in this forecast.
我想談談我們的財務前景。因此,我想重申我們幾週前提供的 2016 年財務前景,收入為 220 億美元至 225 億美元,非 GAAP 每股收益為 5.20 美元至 5.40 美元。我們在第二季度產生的強勁非 GAAP 每股收益包含在該預測中。
So I would like to thank you all for listening to our remarks about the quarter. And I will now like to open the call for questions. Thank you very much.
因此,我要感謝大家聽取我們對本季度的評論。現在我想開始提問。非常感謝。
Operator
Operator
Thank you
謝謝
(Operator Instructions)
(操作員說明)
Your first question comes from the line of Liav Abraham.
你的第一個問題來自 Liav Abraham。
Liav Abraham - Analyst
Liav Abraham - Analyst
Good morning. First question, for Siggi on the generics business. US generics revenues were a little lower than expectations. Can you just talk to us again, about your conviction in pricing stability, on the dynamics in the industry, and was just this a case of us just not properly modeling the impact of Abilify and Nexium in the quarter?
早上好。第一個問題,關於仿製藥業務的 Siggi。美國仿製藥收入略低於預期。你能再和我們談談你對價格穩定性的信念,對行業動態的看法嗎,這只是我們沒有正確模擬 Abilify 和 Nexium 在本季度的影響的一個例子嗎?
And then secondly, Michael, on SD-809 in Huntington's perhaps you can give us an update on where you stand on addressing the FDA's request for additional data? And your confidence that no additional data in humans will be required by the FDA? Thank you very much.
其次,邁克爾,關於亨廷頓舞蹈病的 SD-809,也許你可以向我們介紹一下你在處理 FDA 的額外數據請求方面的立場?您是否相信 FDA 不需要額外的人體數據?非常感謝。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes, thanks, Liav. I think, first of all, it's the old story in the generic business, and we have talked about it many times. It's the short-term volatility, but a long-term profitability that we are seeing in the generic business. I think on the US side, clearly the impact we highlighted, the impact of having a competition on Aripiprazole, Esomeprazole, and Budesonide was very, very significant. I think overall, the underlying business did well.
是的,謝謝,利亞夫。我認為,首先,這是仿製藥行業的老生常談,我們已經談過很多次了。這是短期波動,但我們在仿製藥業務中看到的是長期盈利能力。我認為在美國方面,顯然我們強調的影響,對阿立哌唑、埃索美拉唑和布地奈德進行競爭的影響非常非常重要。我認為總體而言,基礎業務表現良好。
We had that one quality recall in the quarter, which affected our business a little bit, but overall, the impact was that we didn't have any significant new launches. This always happens quarter to quarter, when there's no significant launches. So I think, in terms of the revenue of the US business, we were in line with our expectation going into the quarter.
我們在本季度進行了一次質量召回,這對我們的業務產生了一點影響,但總體而言,影響是我們沒有推出任何重要的新產品。當沒有重大發佈時,這總是每季度發生一次。所以我認為,就美國業務的收入而言,我們符合進入本季度的預期。
In terms of the pricing, the pricing is stable to the same degree as before. We saw approximately in the US, 4% price erosion in the business, in a way very stable from the first quarter And the global pricing impact we saw in the business, in the generic business was approximately 5%. So we are pleased with the environment. And I think we are coming now in line, with our other competitors that have been reporting. We are saying, seeing same price erosion in the market as others. So I think overall, a good quarter. There was a volatility due to the exclusive products we have a year ago, but overall, a very, very good quarter for the generic business of Teva.
在定價方面,定價與之前一樣穩定。我們大約在美國看到,該業務的價格下降了 4%,從第一季度開始就非常穩定,而我們在該業務中看到的全球定價影響,在仿製藥業務中大約為 5%。所以我們對環境很滿意。而且我認為我們現在正在與其他一直在報告的競爭對手保持一致。我們是說,看到市場上與其他市場一樣的價格下跌。所以我認為總的來說,這是一個不錯的季度。由於一年前我們擁有的獨家產品,出現了波動,但總體而言,對於 Teva 的仿製藥業務來說,這是一個非常非常好的季度。
Michael Hayden - Head of R&D, Chief Scientific Officer
Michael Hayden - Head of R&D, Chief Scientific Officer
Thank you, Liav. Just to come back to the SD-809 issue. So we have completed, essentially all of the experimental work. This is also non-human studies, no clinical trials, but measurement of various metabolites. The request for the Type A meeting has gone back for the FDA.
謝謝你,利亞夫。回到 SD-809 問題。所以我們基本上完成了所有的實驗工作。這也是非人體研究,沒有臨床試驗,而是各種代謝物的測量。 A 類會議的請求已返回給 FDA。
We expect this meeting within the next month, with full response to the CRO by the end of September. So we're totally on track. We've been able to, I think complete the results, the issues that the FDA has raised. Of course, it's impossible to totally predict what the FDA will say, but we're very confident that the integrity of the data, and the nature of the response will provide support for approval of this particular product shortly thereafter.
我們希望在下個月召開這次會議,並在 9 月底之前對 CRO 做出全面回應。所以我們完全走上正軌。我認為我們已經能夠完成結果,即 FDA 提出的問題。當然,不可能完全預測 FDA 會說什麼,但我們非常有信心,數據的完整性和響應的性質將為此後不久批准該特定產品提供支持。
Liav Abraham - Analyst
Liav Abraham - Analyst
Thank you.
謝謝你。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Next question?
下一個問題?
Operator
Operator
The next question comes from the line of [Manoj Garg].
下一個問題來自 [Manoj Garg] 的台詞。
Manoj Garg - Analyst
Manoj Garg - Analyst
Hi, thanks for taking the question. I have two, actually one for Eyal, and then one general one. Eyal, in your preliminary guidance issued last month, you included a cost of financing of about 2.8% to 2.9%. But by my math, at least in the initial years, I'm getting a cost of capital substantially lower of about 2.2%. Can you confirm that?
您好,感謝您提出問題。我有兩個,實際上是 Eyal 的一個,然後是一個通用的。 Eyal,在你上個月發布的初步指導意見中,你包括了大約 2.8% 到 2.9% 的融資成本。但根據我的計算,至少在最初幾年,我的資本成本大大降低了 2.2% 左右。你能證實嗎?
Eyal Desheh - CFO
Eyal Desheh - CFO
Yes, I think, Erez just in his comments [said] 2.32%.
是的,我認為,Erez 在他的評論中 [said] 2.32%。
Manoj Garg - Analyst
Manoj Garg - Analyst
Okay, Oh, great. Sorry, I apologize I must have missed it. And then, this morning, Momenta has a press release out saying they're expecting tentative approval on the 40 milligrams this year. So just wanted to see if you guys had any commentary on that?
好的,哦,太好了。對不起,我很抱歉我一定是錯過了。然後,今天早上,Momenta 發布了一份新聞稿,稱他們預計今年將暫時批准 40 毫克。所以只是想看看你們對此有何評論?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
I think, just to say on that, I think Momenta has said before that they have a targeted action day for the 40-milligram this year. So I don't think there's any new information.
我想,就此而言,我想 Momenta 之前說過他們今年有一個針對 40 毫克的有針對性的行動日。所以我認為沒有任何新信息。
Manoj Garg - Analyst
Manoj Garg - Analyst
Okay. Thank you.
好的。謝謝你。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Great. Next question?
偉大的。下一個問題?
Operator
Operator
The next question comes from the line of Vamil Divan.
下一個問題來自 Vamil Divan 的台詞。
Vamil Divan - Analyst
Vamil Divan - Analyst
Great. Thanks so much for taking my questions. I'll just one, if I could on the Copaxone side, building off that last question. Maybe you can give a little bit more insight into what you're seeing in terms of share? And then, it seems like you've got a little bit of benefit on price, since the rebate this quarter. Maybe if you can give us a little more detail there, on how that impacted the numbers, and what your expectations are for pricing going forward? Thanks.
偉大的。非常感謝你回答我的問題。如果可以的話,我會在 Copaxone 方面提出一個問題,以解決最後一個問題。也許您可以更深入地了解您在分享方面看到的內容?然後,自從本季度的回扣以來,您似乎在價格上獲得了一點好處。也許如果你能在那裡給我們更多的細節,關於這如何影響數字,以及你對未來定價的期望是什麼?謝謝。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Mike?
麥克風?
Mike Derkacz - SVP and Head of Global CNS
Mike Derkacz - SVP and Head of Global CNS
Hi, Vamil, thank you very much. So on the Copaxone share, I think we're very, very pleased with the fact that 40-milligram is about 83% of the US market. Of the number one product in the MS category now, of course is 40-milligram, and a 24.1 share. And I think of equal importance is the fact that the EU remains on track with the US. We're quickly approaching a 60% conversion. In Germany, we lead with new patients for Copaxone. And I think this just speaks to the support by payers, by patients, by physicians around the long-proven track record of the safety and efficacy of the product, and a tribute to the team's great work here.
嗨,瓦米爾,非常感謝你。因此,關於 Copaxone 的份額,我認為我們對 40 毫克約占美國市場 83% 的事實感到非常非常高興。現在 MS 類別中排名第一的產品當然是 40 毫克,佔有 24.1 的份額。我認為同樣重要的是,歐盟與美國保持一致。我們正在迅速接近 60% 的轉化率。在德國,我們帶領新患者使用 Copaxone。我認為這只是說明付款人、患者和醫生對產品安全性和有效性的長期可靠記錄的支持,以及對團隊在這裡所做的出色工作的讚揚。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Any additional questions, Vamil?
Vamil,還有其他問題嗎?
Vamil Divan - Analyst
Vamil Divan - Analyst
Just maybe a little bit more on just expectations on pricing going forward, and just a little bit more, if you could break out the impact of the Medicaid rebate, versus the net pricing you're getting, given your price increase?
可能只是對未來定價的預期多一點,如果你能打破醫療補助回扣的影響,而不是你得到的淨定價,考慮到你的價格上漲,那麼多一點?
Mike McClellan - SVP & CFO, Global Specialty Medicines
Mike McClellan - SVP & CFO, Global Specialty Medicines
Yes, what we've seen in the quarter, if we compare to last year is that sales are relatively stable. We have pretty stable volumes, and a little bit of a favorable price impact. We did have a nice upside this quarter, because of a favorable mix. But overall, sales without that favorability would be relatively stable with last year.
是的,如果我們與去年相比,我們在本季度看到的是銷售額相對穩定。我們的銷量相當穩定,價格也有一點有利的影響。由於有利的組合,本季度我們確實取得了不錯的進展。但總體而言,如果沒有這種好感,銷售額將與去年相對穩定。
Vamil Divan - Analyst
Vamil Divan - Analyst
Okay, thank you.
好的謝謝你。
Operator
Operator
The next question comes from the line of Elliot Wilbur.
下一個問題來自 Elliot Wilbur 的台詞。
Elliot Wilbur - Analyst
Elliot Wilbur - Analyst
Thanks, good morning. A question around the recently acquired Anda business, both financial and then strategic. First, with respect to financial. Can we just take the run rate that Actavis talked about, or Allergan talked about in their press release, annualize that, and add that on top of the guidance you have recently provided? In other words, is that business purely additive? And maybe you can talk about sort of what you see kind of in terms of the trends in the -- within the framework that, or the guidance time line that you have previously talked about through 2019?
謝謝,早上好。關於最近收購的 Anda 業務的問題,包括財務和戰略方面的問題。首先,關於財務。我們能否只採用 Actavis 談到的運行率,或者 Allergan 在他們的新聞稿中談到的運行率,將其年化,並將其添加到您最近提供的指導之上?換句話說,那項業務是純加法的嗎?也許你可以談談你在框架內看到的趨勢,或者你之前談到的 2019 年的指導時間表?
And then, just maybe perhaps for Siggi, strategically could you talk about, I mean, what does the business really do for Teva? I guess, the historical knock against it in terms of being owned by a generic company, was that it somehow worked against you, and you're competing with your customers. Obviously, that never hurt Actavis in the amount of time that they owned it. But just curious, how you view that historical perspective, and what that business really enables you to do, or sort of what the benefit is of owning it? Thanks.
然後,也許對 Siggi 來說,從戰略上來說,你能談談,我的意思是,這項業務對 Teva 真正做了什麼?我想,就被一家通用公司擁有而言,歷史上反對它的是,它以某種方式對你不利,而且你正在與你的客戶競爭。顯然,在他們擁有它的時間裡,這從來沒有傷害過 Actavis。但只是好奇,您如何看待這種歷史觀點,以及該業務真正使您能夠做什麼,或者擁有它的好處是什麼?謝謝。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes. Thanks, Elliott. So if we start on the finances, how you need to think about it is, we reported, obviously, the third-party revenue was the total revenue that Allergan reported in their PR. I think what you need to keep in mind, that obviously in the third-party revenue as we reported it, includes Teva revenue. So what we need to do, when we close the transaction is to see if there's an overlap of Actavis versus Teva products, because of the combination and things like that. But overall, the third-party revenue we gave for, estimated for 2016 was in the excess of $1 billion on the revenue.
是的。謝謝,埃利奧特。因此,如果我們從財務開始,你需要考慮的是,我們報告的第三方收入顯然是 Allergan 在其 PR 中報告的總收入。我認為你需要記住的是,顯然在我們報告的第三方收入中,包括 Teva 收入。因此,當我們完成交易時,我們需要做的是查看 Actavis 與 Teva 產品是否存在重疊,因為合併和類似的事情。但總體而言,我們估計 2016 年的第三方收入超過 10 億美元。
In terms of contribution, I think that it's within the [margins] that we gave at guidance a few days back. The contribution to the overall business fits nicely within the guidance ranges that we gave you days back. With regards to strategically, I have to say, I'm extremely excited about this. Obviously, from my Actavis days, to two years ago, and I know this business extremely well.
就貢獻而言,我認為它在幾天前我們在指導中給出的 [利潤率] 之內。對整體業務的貢獻非常符合我們幾天前給你的指導範圍。關於戰略,我不得不說,我對此感到非常興奮。顯然,從我在 Actavis 的日子到兩年前,我對這項業務非常了解。
It really gives us an opportunity to service our customers better, not only on the generic side, but also in terms of our specialty business. It's access to 60,000-plus pharmacies within 24 hours of service. It really is not a big threat to the Big 3 customers, because obviously, Anda is significantly smaller. But it relies as a service function to help also the Big 3 customers, and many of them use Anda as a primary/secondary as we call it, where they rely on Anda to step in, if there's shortage in the market. Also there's biosimilars coming to the market.
它確實讓我們有機會更好地服務我們的客戶,不僅在通用方面,而且在我們的專業業務方面。它可以在 24 小時內訪問 60,000 多家藥店。這對 Big 3 的客戶來說確實不是一個大威脅,因為顯然,安達要小得多。但它依賴於服務功能來幫助 Big 3 客戶,他們中的許多人使用 Anda 作為我們所說的主要/次要,如果市場短缺,他們依靠 Anda 介入。也有生物仿製藥進入市場。
There's an opportunity of delivering straight to the clinics, to the doctors offices. They have a cool chamber, they have the warehouses in Mississippi next to the FedEx site. And really, overall, I think that it's the next best for Teva, in getting closer to the customers, and giving better services in the market. So exciting next step for Teva in the future.
有機會直接送到診所,送到醫生辦公室。他們有一個冷藏室,他們在密西西比州的聯邦快遞站點旁邊有倉庫。真的,總的來說,我認為它是 Teva 的下一個最好的,因為它更接近客戶,並在市場上提供更好的服務。 Teva 未來的下一步非常令人興奮。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Next question?
下一個問題?
Operator
Operator
The next question comes from the line of Gregg Gilbert.
下一個問題來自 Gregg Gilbert。
Gregg GIlbert - Analyst
Gregg GIlbert - Analyst
Yes, thanks. Good morning, good afternoon. First for Erez and Eyal, how much dry powder do you have right now to make acquisitions, and is it fair to say your strategy on acquisitions is much more focused on specialty brands versus generics at this point? And then secondly, for Siggi, not to steal thunder from your upcoming Analyst Day, but how can you best support your confidence in that strong mid single-digit growth outlook for generics over the next several years, in light of just that mid single-digit erosion? Can you give us a little bit more color for that? Thanks, guys.
對了謝謝。早上好,下午好。首先,對於 Erez 和 Eyal,您現在有多少干火藥可以進行收購,現在可以說您的收購戰略更側重於專業品牌而不是仿製藥?其次,對於 Siggi,不是要從即將到來的分析師日搶風頭,而是你如何才能最好地支持你對未來幾年仿製藥強勁的中個位數增長前景的信心,鑑於中個位數-數字侵蝕?你能給我們多一點顏色嗎?多謝你們。
Erez Vigodman - CEO
Erez Vigodman - CEO
So we expect to generate, and I said it and I'm reiterating it now, more than $25 [billion] of free cash flow from the close until the end of 2019, $5 billion basically are there for dividend distribution until the end of 2019, and the rest is going to be divided between paying down debt, and entertaining attractive specialty deals. We might also look at attractive platforms in key growth markets. That is the focus, and that's how we have been shifting the focus from BD perspective to basically to two years, and I'm reiterating it to attractive specialty assets.
所以我們預計會產生,我說過,我現在重申,從結束到 2019 年底,超過 250 億美元的自由現金流,到 2019 年底,基本上有 50 億美元用於股息分配,其餘的將在償還債務和招待有吸引力的專業交易之間分配。我們也可能會關注主要增長市場中有吸引力的平台。這就是重點,這就是我們將重點從 BD 角度轉移到基本上兩年的方式,我重申它是有吸引力的專業資產。
Gregg GIlbert - Analyst
Gregg GIlbert - Analyst
Okay.
好的。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
And Gregg, on my confidence on the mid single-digit growth. Obviously, we have only had the keys for about two days, so it doesn't give me a lot of time to validate what we have talked to before. But everything we have seen in the last 48 hours, has built even more confidence in the data. So what we are doing now, is that we are validating the pipeline. We are validating the IP situation.
還有 Gregg,我對中個位數增長的信心。顯然,我們只拿到鑰匙大約兩天時間,所以我沒有太多時間來驗證我們之前談過的內容。但我們在過去 48 小時內看到的一切,讓我們對數據更有信心。所以我們現在正在做的是,我們正在驗證管道。我們正在驗證 IP 情況。
We are validating the regulatory affairs to understand them, build it up per year. And then, in September hopefully in first half of September, we want to come out with -- to investors and show you the pipeline, and how the possibility it could align throughout the years. With everything we see after 48 hours, it has only built the confidence. But I think you need to wait up until September, so we can show you the real picture, and maybe give you some hint of the molecules, when they could come.
我們正在驗證監管事務以了解它們,並每年建立起來。然後,在 9 月希望在 9 月上半月,我們想向投資者展示管道,以及它如何在這些年內保持一致的可能性。 48 小時後我們看到的一切,只是建立了信心。但我認為你需要等到九月,這樣我們才能向你展示真實的畫面,也許會給你一些分子的暗示,當它們出現時。
Obviously, there are some dates, certain settlements that we want to highlight to investors. But overall, it's the same formula as we talked about before, rebuild about 5% erosion from volume and price, and then a 10% increase from new product launches, which would give us a 5% or mid single-digit overall growth of the business, which I think is reasonable. And we are still sticking by what we talked about before, approximately 1,500 product launches in 2017.
顯然,我們想向投資者強調一些日期,某些和解。但總的來說,這與我們之前談到的公式相同,從數量和價格中重建約 5% 的侵蝕,然後從新產品發布中增加 10%,這將使我們的整體增長達到 5% 或中等個位數。業務,我認為這是合理的。我們仍然堅持我們之前談到的,2017 年大約推出 1,500 種產品。
Erez Vigodman - CEO
Erez Vigodman - CEO
And Gregg, as far as 2016 is concerned, we have the capacity of $3 billion to $4 billion for potential BD deals until the end of 2016.
Gregg,就 2016 年而言,到 2016 年底,我們有 30 億至 40 億美元的潛在 BD 交易能力。
Gregg GIlbert - Analyst
Gregg GIlbert - Analyst
Thanks for that color.
謝謝你的顏色。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Next question?
下一個問題?
Operator
Operator
The next question comes from the line of Jason Gerberry.
下一個問題來自 Jason Gerberry。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
Hi, thanks for taking my question. Just to dovetail I guess off Gregg's question. Siggi, you guys, it looks like you guys were able to keep both Advair programs, yours and Teva's. So kind of curious where you guys stand in the race for a generic Advair? I'm just curious, if you have an updated view, now that you've got both assets?
嗨,謝謝你提出我的問題。只是為了吻合我猜格雷格的問題。 Siggi,你們,看起來你們能夠保留 Advair 程序,你們的和 Teva 的。很好奇你們在通用 Advair 的競爭中處於什麼位置?我很好奇,如果您有更新的視圖,既然您已經擁有這兩種資產?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes. So Jason on the Advair program, obviously again only 48 hours, but both programs, we are going to take two shots at goal. And I think that it highlights that, because we keep both clearly, neither program has completed the Phase III study. So our goal is still to file this by the end of next year, beginning of 2018.
是的。所以 Jason 在 Advair 計劃中,顯然又只有 48 小時,但是這兩個計劃,我們都要射門兩次。我認為這突出了這一點,因為我們清楚地保留了這兩個項目,所以這兩個項目都沒有完成 III 期研究。所以我們的目標仍然是在明年年底,即 2018 年初提交這份文件。
We have to see, obviously, there's many risks in the way, but I think that it gives us an opportunity in taking at least two shots at goal. Our intention is to continue with both programs, so we have a better chance of introducing a generic interchangeable AB-rated Advair to the market, in not so distant future. But we are not at a point in time now where we can give you more exact time lines.
顯然,我們必須看到這條路上有很多風險,但我認為這給了我們至少兩次射門的機會。我們打算繼續這兩個項目,這樣我們就有更好的機會在不遠的將來向市場推出通用的可互換的 AB 級 Advair。但是我們現在還沒有到可以為您提供更準確時間表的時間點。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
Okay. And if I could squeeze a follow-up in just on -- actually on Vamil's question around the Medicaid mix. Is that just a 2Q phenomenon, or are you kind of transitioning away from the Medicaid business, and should we expect better gross to nets as a by-product of that on a go forward basis? Thanks.
好的。如果我可以緊接著——實際上是關於 Vamil 關於醫療補助組合的問題。這只是一個 2Q 現象,還是你正在從醫療補助業務中過渡,我們是否應該期待更好的淨收入作為向前發展的副產品?謝謝。
Mike McClellan - SVP & CFO, Global Specialty Medicines
Mike McClellan - SVP & CFO, Global Specialty Medicines
Yes, what we've seen in the quarter is that, the Medicaid scripts tend to come in on a 9 to12 month lag. So as we had the launch of Glatopa, as a competitor, we've made estimates over the quarter. And what we've seen as a slightly favorable mix come in. Some of that is affecting the go forward business, but a chunk of it is a revision of past estimates, which the underlying business as we said before is relatively stable. So the upside you see versus last quarter -- last year is basically the revision estimates.
是的,我們在本季度看到的是,Medicaid 腳本往往會滯後 9 到 12 個月。因此,當我們作為競爭對手推出 Glatopa 時,我們對本季度進行了估算。我們所看到的略微有利的組合出現了。其中一些影響了未來的業務,但其中很大一部分是對過去估計的修正,正如我們之前所說,基礎業務相對穩定。所以你看到的與上個季度相比的好處——去年基本上是修訂估計。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
Okay thanks.
好的謝謝。
Operator
Operator
The next question comes from the line of Umer Raffat.
下一個問題來自 Umer Rafat。
Umer Raffat - Analyst
Umer Raffat - Analyst
Hi thanks for taking my questions. Perhaps a few if I may. Erez, how are you thinking about the timing of capital deployment in specialty? And I know you mentioned four core therapeutic areas, so I know it's neurology, pain and respiratory. Is your fourth one, oncology, and are you open to BD on oncology?
您好,感謝您提出我的問題。如果可以的話,也許有一些。埃雷茲,你如何看待專業資本部署的時機?我知道你提到了四個核心治療領域,所以我知道它是神經病學、疼痛和呼吸。你的第四個是腫瘤學,你對腫瘤學的 BD 持開放態度嗎?
Siggi, so on generics, it seems like volumes are down 10% sequentially versus first quarter, and the reported sales are also down similar numbers. So what I'm trying to understand is, are you sticking to like a 4% price erosion, and is anything, is there any part of the portfolio that's eroding price beyond that where you're surrendering volumes. Just wanted to understand what we're seeing in IMS?
Siggi 等仿製藥的銷量似乎比第一季度下降了 10%,報告的銷售額也下降了類似的數字。所以我想了解的是,你是否堅持 4% 的價格侵蝕,並且是什麼,投資組合中是否有任何部分的價格侵蝕超出了你放棄數量的範圍。只是想了解我們在 IMS 中看到了什麼?
And then finally, Eyal, I had a question on non-GAAP. So the 20% royalty on Bendeka is not reflected in the non-GAAP P&L. So I just wanted to understand, how can investors better understand non-GAAP results, especially if Bendeka continues to be an important part for many years to come?
最後,Eyal,我有一個關於非 GAAP 的問題。因此,Bendeka 的 20% 特許權使用費並未反映在非 GAAP 損益表中。所以我只是想了解,投資者如何才能更好地理解非 GAAP 結果,尤其是如果 Bendeka 在未來許多年繼續發揮重要作用?
Erez Vigodman - CEO
Erez Vigodman - CEO
So Umer, thank you for the questions. The four therapeutic areas encompass neurodegenerative diseases/ movement disorders, headache/ migraine, pain, and respiratory. We might pursue BD deals in -- already in 2016 and 2017.
Umer,謝謝你的提問。這四個治療領域包括神經退行性疾病/運動障礙、頭痛/偏頭痛、疼痛和呼吸系統疾病。我們可能會在 2016 年和 2017 年尋求 BD 交易。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
So Umer, quickly on the volume. So first of all, there's probably three or four things to this question. Overall, the IMS volume is not as accurate as we would like it to be. It's still a decline, but it's not really at the 9% we are talking about. So there are a few things that play into it.
所以烏默爾,很快就上了音量。所以首先,這個問題可能有三四件事。總的來說,IMS 卷並不像我們希望的那樣準確。它仍然在下降,但並不是我們所說的 9%。所以有一些事情在起作用。
First of all, the three products that we talked about, obviously play into it. The second thing that plays into it is the Godollo issues which we mentioned before, the quality issue we have in our injectable site. But we also have versus previous years, there's an impact from a third-party manufacturer in India, Emcure which has a significant volume impact, but very little impact on our profitability or the top line.
首先,我們談到的三種產品顯然發揮了作用。第二件事是我們之前提到的 Godollo 問題,我們的注射部位存在質量問題。但與往年相比,我們也有來自印度第三方製造商 Emcure 的影響,這對銷量產生了重大影響,但對我們的盈利能力或收入影響很小。
So overall, the business itself is fairly stable. As I mentioned in the beginning, we are seeing exactly the 4% price erosion. There is such not much movement in the other volumes. If you take away these two exceptions, the rest of the volume seems to be intact. And then some of the product there has been a small volume increase. So overall, a stable business, 4% price erosion in the US, and I think a great base to build on now, when we combine the two businesses for the future.
所以總的來說,業務本身是相當穩定的。正如我在開頭提到的,我們正好看到 4% 的價格下跌。其他卷中沒有太多動作。如果去掉這兩個例外,卷的其餘部分似乎完好無損。然後一些產品出現了小幅增長。所以總的來說,一個穩定的業務,美國的價格下降了 4%,我認為當我們為未來合併這兩個業務時,現在可以建立一個很好的基礎。
Eyal Desheh - CFO
Eyal Desheh - CFO
And Umer, on the Bendeka royalty. The Bendeka royalties are a charge into the GAAP and into non-GAAP. What you have seen on a regular basis, what you have seen is as a result of the win that we had, we had to increase the future value of the Eagle transaction, and that is the -- a bit over $100 million entry that we have in the GAAP result, that was eliminated to non-GAAP. But on a regular basis, the royalties are part of the cost.
還有 Umer,關於 Bendeka 皇室成員。 Bendeka 特許權使用費計入 GAAP 和非 GAAP。你經常看到的,你看到的是我們獲勝的結果,我們不得不增加 Eagle 交易的未來價值,那就是 - 我們的入場金額略高於 1 億美元在 GAAP 結果中,該結果被排除在非 GAAP 之外。但通常情況下,特許權使用費是成本的一部分。
Umer Raffat - Analyst
Umer Raffat - Analyst
Thank you very much (multiple speakers)
非常感謝(多人發言)
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Just to give you a little bit more flavor, in the four therapeutic areas. Of course, migraine and pain is our leading areas, with total number of programs around 35, 12 in migraine and pain, 10 in movement disorders, neurodegeneration, around 9 in respi. And then, we had some others, for example, neuropsychiatry as well, and biosimilar development. So it's quite focused, and very specifically focused in the areas that we've spoken about in the past.
只是為了在四個治療領域給你更多的味道。當然,偏頭痛和疼痛是我們的領先領域,項目總數約為 35 個,其中偏頭痛和疼痛有 12 個,運動障礙、神經變性有 10 個,respi 有 9 個左右。然後,我們還有其他一些,例如神經精神病學和生物仿製藥開發。所以它非常專注,非常專注於我們過去談到的領域。
Umer Raffat - Analyst
Umer Raffat - Analyst
Thank you.
謝謝你。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Rose?
玫瑰?
Operator
Operator
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
I have two questions. The first is for Siggi, the second is for Michael. So with respect to the Anda business that you're acquiring, could you just provide a little bit more perspective on whether you expect Anda to lose supplier customers, because suppliers are less inclined to work with Teva as a much bigger leader in the US generics market? And then second, with respect to SD-809, Michael, are you planning to launch the drug next spring, meaning how high is your conviction that you'll be getting the drug approved next spring, or is there enough uncertainty that you can't have extremely high confidence at this point? Thank you.
我有兩個問題。第一個是給 Siggi 的,第二個是給 Michael 的。因此,關於您要收購的 Anda 業務,您能否就您是否預計 Anda 會失去供應商客戶提供更多觀點,因為供應商不太願意與 Teva 合作,因為它是美國仿製藥領域更大的領導者市場?其次,關於 SD-809,邁克爾,你是否計劃在明年春天推出這種藥物,這意味著你對明年春天將獲得批准的藥物的信心有多高,或者是否有足夠的不確定性你可以'在這一點上沒有極高的信心?謝謝你。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Thanks, David. So on the Anda thing. So first of all keep in mind, that Anda will be -- when we close the transaction, a standalone function within Teva. There will be a Chinese wall, it's not part of the ongoing business, and we will report it separately.
謝謝,大衛。所以關於安達的事情。所以首先要記住,當我們關閉交易時,Anda 將是 Teva 中的一個獨立功能。會有一堵中國牆,這不是正在進行的業務的一部分,我們將單獨報告。
Second thing to think about is Anda is a great service function to the other pharma companies, so they really want to work with Anda. Anda has a great business working with the independent pharmacies. And also their role of being, as I mentioned before the primary/secondary, I think even though we are competitors in the market, I think the companies see that as a great opportunity to be in the position to work with Anda. And Anda has a reputation in the market to be one of the best supplier, best service, great phone centers. And maybe the third point to mention, yes, there has been a regular competition between Actavis and Teva, but Teva always has used Anda in the past.
其次要考慮的是,安達對其他製藥公司來說是一個很好的服務功能,所以他們真的很想與安達合作。 Anda 與獨立藥店的合作非常成功。還有他們的角色,正如我在小學/中學之前提到的,我認為即使我們是市場上的競爭對手,我認為這些公司認為這是與 Anda 合作的絕佳機會。 Anda 在市場上享有盛譽,是最好的供應商、最好的服務和最好的電話中心之一。也許要提到的第三點,是的,Actavis 和 Teva 之間一直存在定期競爭,但 Teva 過去一直使用 Anda。
Anda has been very professional. And it's also for that reason why we are so comfortable with Anda, because we knew that the confidentiality of any Teva information never went over to Actavis, or the other way around. So I think this is an opportunity for the customers, for our competitors. In terms of the customers, how they react, I think Anda as I mentioned before is a relatively small, it's more of a service, it's a service more to the independent. It can help the big three customers, if anything, so I don't see them as a big threat to the big three customers.
安達非常專業。這也是我們對 Anda 如此滿意的原因,因為我們知道任何 Teva 信息的機密性都不會交給 Actavis,反之亦然。所以我認為這對客戶和我們的競爭對手來說都是一個機會。就客戶而言,他們的反應如何,我認為我之前提到的 Anda 相對較小,它更像是一種服務,它更像是為獨立人士提供的服務。它可以幫助三大客戶,如果有的話,所以我不認為他們對三大客戶構成很大威脅。
Michael Hayden - Head of R&D, Chief Scientific Officer
Michael Hayden - Head of R&D, Chief Scientific Officer
And David, with regard to SD-809, we're confident that we will be able to launch this by the end of the first quarter in 2017. Important, the issues we believe have been resolved. Important, also to remember that this would be only the second drug ever approved for Huntington's disease in the United States, the last being tetrabenazine itself in 2008.
大衛,關於 SD-809,我們有信心能夠在 2017 年第一季度末推出它。重要的是,我們認為問題已經解決。重要的是,還要記住,這將是美國有史以來批准用於治療亨廷頓舞蹈病的第二種藥物,最後一種是 2008 年批准的丁苯那嗪本身。
This is a fine proved product, with improvement in movement disorder, chorea, improvement in appetite, no swallowing difficulties, walking, and a whole host of others that improve the quality of life of patients, without some of the obvious and terrible side effects associated with tetrabenazine, particularly including a tendency to depression and suicide, which is frequent in these patients. This will represent a major advance for patients, and we do know recent publications that the number of patients with Huntington's disease has probably been underestimated. It may be a significant increase on what is seen previously. So we're confident about the response that we have. And we also recognize importantly, the unmet need in terms of patients, and the broad spectrum of possibility in terms of improvement in the quality of life of these patients. So we're looking forward to the launch of the second product for Huntington's disease in the United States early next year.
這是一個經過驗證的優秀產品,可以改善運動障礙、舞蹈病、食慾改善、無吞嚥困難、行走和許多其他改善患者生活質量的問題,並且沒有一些明顯和可怕的相關副作用丁苯那嗪,特別是包括抑鬱症和自殺的傾向,這在這些患者中很常見。這將代表患者的重大進步,我們確實知道最近的出版物表明亨廷頓病患者的數量可能被低估了。這可能比之前看到的有顯著增加。所以我們對我們的回應充滿信心。我們還認識到重要的是,患者的需求未得到滿足,並且在改善這些患者的生活質量方面存在廣泛的可能性。因此,我們期待明年初在美國推出第二種治療亨廷頓舞蹈症的產品。
David Risinger - Analyst
David Risinger - Analyst
Thanks very much. And one quick follow-up on that. Why did the FDA assign a six-month review clock rather than a two month review clock, given the desperate need of many patients in the United States?
非常感謝。並對此進行快速跟進。鑑於美國許多患者的迫切需要,為什麼 FDA 指定了六個月的審查時鐘而不是兩個月的審查時鐘?
Michael Hayden - Head of R&D, Chief Scientific Officer
Michael Hayden - Head of R&D, Chief Scientific Officer
That's an excellent question. It's technical, so if you look at the Type 1 or Type 2 submission, Type 1 says, that it's a review of data and no new data. Type 2 refers to new data. So the FDA has the opportunity, if it's very technical, they could go as much as six months. Of course, we're hoping for less. But we don't know how they'll interpret this as totally new data, extrapolation of old data so. And the FDA has not yet determined this, because we haven't really, they haven't yet seen the data. So we're giving the outside view of this. But of course, we would hope this might be earlier in view of the unmet need.
這是一個很好的問題。這是技術性的,所以如果您查看類型 1 或類型 2 提交,類型 1 說,這是對數據的審查,沒有新數據。類型 2 指的是新數據。所以 FDA 有機會,如果它非常技術性,他們可能會持續六個月。當然,我們希望更少。但我們不知道他們將如何將其解釋為全新的數據,即舊數據的推斷。 FDA 還沒有確定這一點,因為我們真的還沒有,他們還沒有看到數據。所以我們給出了這個的外部視圖。但當然,鑑於未滿足的需求,我們希望這可能會更早。
David Risinger - Analyst
David Risinger - Analyst
Thank you.
謝謝你。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Next question?
下一個問題?
Operator
Operator
Thank you. Your next question comes from the line of Randall Stanicky.
謝謝你。你的下一個問題來自 Randall Stanicky。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Great, thanks. I just have two. The first is for Siggi, and then for David. Siggi, has some of your Indian peers collected approvals that they are not launching, or at least have not yet launched? And we see some of our domestic competitors here, having some pretty significant competitive challenges, how much risk is that of irrational behavior, or an opportunity for you is that? How do you view that?
太謝謝了。我只有兩個。第一個是 Siggi,然後是 David。 Siggi,您的一些印度同行是否已獲得批准,但他們尚未啟動,或者至少尚未啟動?我們在這裡看到我們的一些國內競爭對手面臨著一些非常重大的競爭挑戰,非理性行為的風險有多大,或者對你來說是一個機會?你怎麼看?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes. So Randall, with the 208 generic companies in the US market, the competition is fierce. There's no question about it. There has been more approvals, you have seen -- there is a pick up of approval, but overall, there hasn't been so many launches. Because also, I think companies know and we know it ourselves, if you are the eighth or the ninth approval, it is a very difficult market to up value to the customers to bring a product to the market.
是的。所以蘭德爾,與美國市場的208家仿製藥公司,競爭非常激烈。毫無疑問。你已經看到了更多的批准——批准有所增加,但總體而言,並沒有那麼多的發布。因為,我認為公司知道,我們自己也知道,如果你是第八次或第九次批准,這是一個非常困難的市場,要為客戶增加價值,將產品推向市場。
So many of the approvals, because you see a lot -- many product approvals, but they are not the exclusive approvals so much. So I think the companies are different. I think most companies have started to understand how the market functions. But it is a fierce competition in the market. There's no question in my mind, that with 208 companies with an --on average now from the FDA, approximately 55 to 60 approvals every month, we need to be on top of our game.
這麼多的批准,因為你看到了很多 - 許多產品批准,但它們並不是獨家批准。所以我認為公司是不同的。我認為大多數公司已經開始了解市場是如何運作的。但這是一個激烈的市場競爭。在我看來,毫無疑問,現在有 208 家公司平均每月獲得 FDA 的批准約 55 至 60 項,我們需要在我們的遊戲中處於領先地位。
The other side of the coin is, of course, that we have 336 ANDAs pending at the FDA in the new combined Teva. So when the FDA picks up the pace in approving our competitor's products, we have approximately 10% of all ANDAs is in the name of Teva now at the FDA. So I think we will also see the benefit from the FDA picking up the pace. And that will give me, that gives me the comfort of the mid single-digit growth. But you're absolutely right. This is a crowded market. There's a lot of competition and there's new approvals coming.
當然,硬幣的另一面是,我們有 336 個 ANDA 在新合併的 Teva 中等待 FDA 批准。因此,當 FDA 加快批准我們競爭對手產品的步伐時,我們現在有大約 10% 的 ANDA 以 Teva 的名義提交給 FDA。所以我認為我們也會看到 FDA 加快步伐帶來的好處。這將給我,讓我對中等個位數增長感到欣慰。但你是絕對正確的。這是一個擁擠的市場。競爭激烈,新的批准即將到來。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Great. And just if I can switch -- just to Dave for a second on Copaxone. The next major data point we're going to have here, are going to be the three IPR decisions later this month. And if they go against Teva, I guess, a couple questions. Do we know how Judge Sleet is going to treat those, if he will include those in the litigation or not? Obviously, the fourth patent would be included. And then, does that have any impact relative to the PTAB finding, if relative to what Judge Sleet views on those patents. Can you get an injunction off of anything he may find?
偉大的。只是如果我可以切換 - 就在 Copaxone 上給 Dave 一秒鐘。我們將在這裡獲得的下一個主要數據點將是本月晚些時候的三項知識產權決定。如果他們反對 Teva,我想,有幾個問題。我們是否知道 Sleet 法官將如何對待這些人,他是否會將這些人包括在訴訟中?顯然,第四項專利將被包括在內。然後,如果相對於 Sleet 法官對這些專利的看法,這對 PTAB 的調查結果有任何影響嗎?你能從他可能找到的任何東西中獲得禁令嗎?
David Stark - SVP, General Counsel, Global Markets & GSM
David Stark - SVP, General Counsel, Global Markets & GSM
Yes, hi, Randall. This is David. Thanks for the question. So the judges have discretion, in terms of how they manage their docket. But that said, we have a pretty high degree of confidence that, in that fact pattern that you described, that Judge Sleet would go ahead, just as you mentioned, and particularly on the fourth patent which is not going to be part of the IPR decisions. So our view is that there's a very high degree of likelihood that the trial will go ahead. And thanks for the question around the injunction, because those patents are in the Orange Book, and unless and until those patents would be cancelled, there would be an automatic injunction if we were to prevail in front of Judge Sleet.
是的,嗨,蘭德爾。這是大衛。謝謝你的問題。因此,法官在如何管理他們的案卷方面擁有自由裁量權。但話雖如此,我們非常有信心,按照您描述的事實模式,正如您提到的那樣,Sleet 法官會繼續推進,特別是第四項專利,它不會成為 IPR 的一部分決定。因此,我們的觀點是,試驗繼續進行的可能性非常高。感謝關於禁令的問題,因為這些專利在橙皮書中,除非並且直到這些專利被取消,否則如果我們在 Sleet 法官面前勝訴,就會有自動禁令。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
And can he re-litigate the patents, even if the PTAB invalidates them?
他能否對專利重新提起訴訟,即使 PTAB 宣布這些專利無效?
David Stark - SVP, General Counsel, Global Markets & GSM
David Stark - SVP, General Counsel, Global Markets & GSM
So again, if the PTAB rules against us in the IPR, that would be appealed to the Federal Circuit, just as Just Sleet's decision would be appealed to the Federal Circuit. And until the PTAB procedure completely runs its course, we would still have an injunction, an automatic one in front of Judge Sleet if we were to prevail. I hope that gets to your question.
因此,如果 PTAB 在 IPR 中作出不利於我們的裁決,我們將上訴至聯邦巡迴法院,就像 Just Sleet 的決定將上訴至聯邦巡迴法院一樣。在 PTAB 程序完全運行之前,如果我們勝訴,我們仍然會有禁令,自動在 Sleet 法官面前發出。我希望這能解決你的問題。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
No, it's helpful, thank you.
不,這很有幫助,謝謝。
Operator
Operator
Thank you. Your next question comes from the line of Ken Cacciatore.
謝謝你。您的下一個問題來自 Ken Cacciatore。
Ken Cacciatore - Analyst
Ken Cacciatore - Analyst
Hi thanks, just a couple. First Siggi, I know it's been brief, but you should have some insights at least into the Allergan's generic business operating margin maybe? And just general health, even though it's been a short window of time, if you could just maybe compare and contrast to your current operations standalone? And then also just a general question whoever wants to field it. On Mylan's Advair, you all are clearly an interested party here, you're a major shareholder. So can you give us any insights into your belief as that around a shareholder? Clearly, you own a lot, and would, could be a good liquidity event, so wanted your perspective if you thought it could be AB-rated and approved?
嗨,謝謝,只有一對。首先是 Siggi,我知道它很簡短,但你至少應該對 Allergan 的通用業務運營利潤率有一些了解?只是總體健康狀況,即使時間很短,您是否可以單獨比較和對比當前的操作?然後也只是一個一般性問題,無論誰想要提出這個問題。在Mylan的Advair上,你們顯然都是這裡的利益相關者,你們是大股東。那麼,您能否就您圍繞股東的信念向我們提供任何見解?很明顯,你擁有很多,並且可能會成為一個很好的流動性事件,所以如果你認為它可以被評為 AB 級並獲得批准,那麼需要你的觀點嗎?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
A good question, Ken. So first of all on the operating margin, we obviously, we cannot comment on their quarter two business. I think Allergan has their results next week. But overall, we are very pleased with what we see. We have a stable business, it's growing, I think a very interesting pipeline. And we also highlighted, when we gave our guidance to the Street that really, on both sides in Teva and in Actavis, both R&D groups did amazing jobs over the last 12 months to continue to build the pipeline.
一個好問題,肯。因此,首先關於營業利潤率,我們顯然無法評論他們的第二季度業務。我認為 Allergan 下週會有結果。但總的來說,我們對所看到的感到非常滿意。我們有一個穩定的業務,它正在增長,我認為這是一個非常有趣的管道。我們還強調,當我們向華爾街提供指導時,在 Teva 和 Actavis 的雙方,兩個研發團隊在過去 12 個月中都做了出色的工作,繼續建設管道。
In terms of the operating margin, we have to see, we have to do the calculation. As I mentioned before, we are at close to 27% in the generic business in Teva for this quarter. My guess would be they are at about just over 30% in their operating profit. You have then to keep in mind that we are swallowing all the negative synergies now, because all the divestitures will come in now, and all of the costs will still be on the books.
就營業利潤率而言,我們必須看到,我們必須進行計算。正如我之前提到的,本季度我們在 Teva 的仿製藥業務中所佔比例接近 27%。我的猜測是他們的營業利潤率剛剛超過 30%。然後你必須記住,我們現在正在吞下所有的負面協同效應,因為所有的資產剝離現在都會進來,所有的成本仍然在賬面上。
So there will be a small hit on the operating profit for the first few quarters, until we start to realize the synergies. So there will be a negative bump in the beginning, which will then over the three years, until the end of 2019, I would foresee the generic business to be in the mid-30s in terms of operating profit. But you need to I think model it pretty accurately because of the negative bump you will see in the beginning, due to the divestitures hitting us on day one.
因此,在我們開始實現協同效應之前,前幾個季度的營業利潤將受到輕微影響。所以一開始會出現負增長,然後在三年內,直到 2019 年底,我預計仿製藥業務的營業利潤將達到 30 多歲。但是你需要我認為它非常準確地建模,因為你會在開始時看到負面衝擊,因為在第一天就對我們進行了資產剝離。
In terms of Mylan Advair, I think it's not for us to comment. I have to say, I think it's a great achievement that they submitted an ANDA that is under review. We can't comment, we haven't seen the dossiers. But they have a targeted action day, not so -- quite close in time. But we can't comment on their approvability, but clearly, an achievement to finish and submit a dossier in this time frame they talked about.
就Mylan Advair而言,我認為這不是我們可以評論的。我不得不說,我認為他們提交了正在審查中的 ANDA 是一項偉大的成就。我們無法發表評論,我們還沒有看到檔案。但他們有一個有針對性的行動日,不是這樣——時間非常接近。但我們無法評論他們的認可度,但很明顯,在他們談到的這個時間範圍內完成並提交檔案是一項成就。
Ken Cacciatore - Analyst
Ken Cacciatore - Analyst
Thank you.
謝謝你。
Erez Vigodman - CEO
Erez Vigodman - CEO
Maybe just to clarify on what Siggi just said, 2017 already net synergies, after the negative synergies is positive, $0.4 billion of positive net synergies. That's something that we shared with the Street two weeks ago. So just to give meaning to the statement made by Siggi, we are positive already $400 million positive after negative synergies in 2017.
也許只是為了澄清 Siggi 剛才所說的,2017 年已經產生了淨協同效應,在負協同效應為正之後,4 億美元的正淨協同效應。這是我們兩週前與華爾街分享的內容。因此,為了讓 Siggi 的聲明有意義,我們認為在 2017 年的負面協同效應之後已經有 4 億美元的正收益。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Rose, next question?
羅斯,下一個問題?
Operator
Operator
Thank you. Your next question comes from the line of David Maris.
謝謝你。你的下一個問題來自 David Maris。
David Maris - Analyst
David Maris - Analyst
Good morning. Just first, one clarification. What were the Takeda revenues in the quarter, and is that a fair run rate and is it growing? And then, Erez, in a recent interview, and previously you've spoken about the merging of information, technology, and therapeutics as an important part of healthcare, and that Teva's going to participate in that. Can you maybe describe what your efforts are there right now?
早上好。首先,澄清一下。武田在本季度的收入是多少,這是一個合理的運行率嗎?它是否在增長?然後,埃雷茲,在最近的一次採訪中,之前你談到了信息、技術和治療的融合作為醫療保健的重要組成部分,梯瓦將參與其中。你能描述一下你現在所做的努力嗎?
Erez Vigodman - CEO
Erez Vigodman - CEO
Sure. I think the best way to describe things at this stage is as follows. First, we focus on unlocking value from generics, unlocking value from specialty. There is a huge opportunity for us to generate value to our shareholders from generics, and from specialty on a standalone basis.
當然。我認為現階段最好的描述方式如下。首先,我們專注於從仿製藥中釋放價值,從專業中釋放價值。我們有巨大的機會從仿製藥和獨立的特殊藥物中為我們的股東創造價值。
Over time, we strongly believe that the focus in the industry will over time shift from products only to the broader unmet needs of patients, increasing adherence compliance, addressing prevention, prediction. And basically, that's an opportunity for us, we believe that we are positioned as a Company to address broader unmet needs of patients in a way which is not confined to medicines only.
隨著時間的推移,我們堅信,隨著時間的推移,行業的重點將從單純的產品轉移到更廣泛的患者未滿足的需求,提高依從性,解決預防和預測問題。基本上,這對我們來說是一個機會,我們相信我們被定位為一家公司,以一種不僅僅局限於藥物的方式來解決更廣泛的患者未滿足的需求。
On a step by step basis, continue to unlock value from generics and from specialty, will catch the synergies, and we will create more [proximity] with patients. And in moves that we have been already carrying out, we'll be in a position to share that with the Street, I believe early next year or in the course of 2017, with more detail.
在循序漸進的基礎上,繼續從仿製藥和專科藥物中釋放價值,抓住協同效應,我們將與患者創造更多[親近度]。在我們已經實施的舉措中,我們將能夠與華爾街分享更多細節,我相信明年初或 2017 年期間。
Eyal Desheh - CFO
Eyal Desheh - CFO
And David, on the question on the Takeda revenue contribution. We are not providing country by country, and also the confidentiality agreement with Takeda prevents us from being specific. But there is a view, if you go into the details in our P&L, you can see some estimate of profit contribution with the minority interest line, because we get 51% of the profit.
大衛,關於武田的收入貢獻問題。我們不按國家/地區提供,而且與武田的保密協議使我們無法具體說明。但有一種觀點,如果你在我們的 P&L 中詳細了解,你可以看到一些對少數股東利益線的利潤貢獻的估計,因為我們獲得了 51% 的利潤。
David Maris - Analyst
David Maris - Analyst
Great, thank you very much.
太好了,非常感謝。
Operator
Operator
Thank you. Your next question comes from the line of Chris Schott.
謝謝你。你的下一個問題來自 Chris Schott。
Chris Schott - Analyst
Chris Schott - Analyst
Great. Thanks very much, just two here. Maybe first, can you talk about price opportunities on the combined generic portfolio, now that the deal is closed? As you kind of review the pro forma business, do you see the opportunity to raise price on select products here? Second question was on the environment for business development right now? I think you talked earlier about maybe $3 billion to $4 billion of capacity in the near-term and a lot more over time. But how attractive of a market are you seeing out there? Have you seen any change in expectations either from sellers or in the competitive environment for assets, that make this either a more or less attractive time to be pursuing some of the specialty products? Thanks very much.
偉大的。非常感謝,這裡只有兩個。也許首先,既然交易已經結束,你能談談合併仿製藥組合的價格機會嗎?當您回顧備考業務時,您是否看到了提高所選產品價格的機會?第二個問題,關於現在的商業發展環境?我想你早些時候談到了短期內可能有 30 億到 40 億美元的產能,隨著時間的推移會更多。但是,您認為那裡的市場有多大吸引力?您是否看到賣家或資產競爭環境的期望發生任何變化,這使得現在成為購買某些特色產品或多或少有吸引力的時間?非常感謝。
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes, thanks, Chris. On the pricing, as you know, and we know that, the size really doesn't affect the pricing. And I have a strong feeling when you have over 200 competitors, size has nothing to do about pricing. I think the pricing comes with shortages in the market. If you have an exclusive product, if there's some kind of dysfunction in the market, there might be a small pricing opportunity that usually comes in and comes out. But overall, the size, and being a combined company doesn't play into that. I feel quite strongly about that.
是的,謝謝,克里斯。關於定價,如您所知,我們也知道,尺寸確實不會影響定價。當你有超過 200 個競爭對手時,我有一種強烈的感覺,規模與定價無關。我認為定價伴隨著市場短缺。如果你有獨家產品,如果市場出現某種功能障礙,可能會有一個小的定價機會,通常會來來去去。但總的來說,規模和成為一家合併後的公司並沒有起到什麼作用。我對此有強烈的感覺。
The environment has to do with shortages, new products. And of course we have a lot of exclusive products. As we mentioned, about 115 first-to-files that are pending, and I think those are the biggest pricing opportunities we have in the future. I think also what we are going to do, Chris. And this is part of it, is we are working hand in hand with our TGO, our operation colleagues, to have our products available. Because when there's a shortage in the market, the opportunity is to service our customers even better than we do today. And this is now an initiative, so that we are working on very hard in the new Teva, in the new combined Teva, is how can we have more products available? Because when there are shortages in the market, the opportunity comes that we have the products available on a short notice to service our customers. So I think that will be the focus, much more than day one, we can increase the prices. I don't see that in the cards.
環境與短缺、新產品有關。當然,我們有很多獨家產品。正如我們所提到的,大約有 115 個先到者文件正在等待處理,我認為這是我們未來最大的定價機會。我也在想我們將要做什麼,Chris。這是其中的一部分,我們正在與我們的 TGO、我們的運營同事攜手合作,以提供我們的產品。因為當市場出現短缺時,機會就是為我們的客戶提供比現在更好的服務。現在這是一項舉措,因此我們在新的 Teva 中非常努力地工作,在新合併的 Teva 中,我們如何才能提供更多產品?因為當市場出現短缺時,機會就來了,我們可以在短時間內提供產品來為我們的客戶提供服務。所以我認為這將是重點,不僅僅是第一天,我們可以提高價格。我沒有在卡片上看到這一點。
Erez Vigodman - CEO
Erez Vigodman - CEO
And on the second one we see attractive opportunities to grow our business through BD with complementing core TAs. We don't see basically shifting the expectations of potential sellers. What plays in our favor is basically, I would say the perception, and the way we have been growing and developing our specialty franchise. And there is more willingness of potential sellers or potential partners to collaborate with us, so to discuss with us potential deals. And the more we are able to increase the critical mass, and to cement the competitiveness, executing on our strategies that was [crafted for each one] of the TAs, there are more attractive opportunities for us, and more willingness to entertain deals with us. And that's maybe the most important factor, the influence is likely of potential successful deals that we might entertain.
在第二個方面,我們看到了通過 BD 與補充核心 TA 來發展我們的業務的誘人機會。我們認為潛在賣家的期望基本上不會發生變化。對我們有利的基本上是,我想說的是人們的看法,以及我們一直在發展和發展我們的專業特許經營權的方式。並且有更多的潛在賣家或潛在合作夥伴願意與我們合作,因此與我們討論潛在的交易。我們越能增加臨界質量,鞏固競爭力,執行我們為每個 TA 制定的戰略,我們就會有更多有吸引力的機會,並且更願意與我們進行交易.這可能是最重要的因素,影響可能是我們可能會接受的潛在成功交易。
Michael Hayden - Head of R&D, Chief Scientific Officer
Michael Hayden - Head of R&D, Chief Scientific Officer
And if I could just add to that, as we look at more focus in some of our colleagues and other pharma companies with AZ and Takeda and others refocusing their pipelines, and the recognition of Teva becoming a significant player in migraine, pain, movement disorders, neurodegeneration and respi, we're seeing a significant number of opportunities, very exciting come our way.
如果我可以補充一點,當我們看到我們的一些同事和其他製藥公司更加關注 AZ 和 Takeda 以及其他公司重新調整他們的管道時,以及 Teva 成為偏頭痛、疼痛、運動障礙領域的重要參與者的認可,神經變性和呼吸系統疾病,我們看到了大量的機會,非常令人興奮。
Also looking at innovative types of partnerships, sharing the risk, sharing the benefits, novel complementarities. And also the partners that we are looking at, are not just around product, but also around technologies that can enhance in compliance and adherence, and add to the quality of life of the patients we serve. So we are extremely busy looking at numerous products. And I think Teva is becoming recognized as a place to think about for the appropriate development, because of the capabilities in the TAs that we focus in.
還著眼於創新類型的伙伴關係,分擔風險,分享利益,新穎的互補性。我們正在尋找的合作夥伴不僅圍繞產品,還圍繞可以提高依從性和依從性並提高我們所服務患者的生活質量的技術。所以我們非常忙於尋找眾多產品。而且我認為 Teva 正在被公認為適當開發的地方,因為我們專注於 TA 的能力。
Chris Schott - Analyst
Chris Schott - Analyst
Thank you.
謝謝你。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Rose?
玫瑰?
Operator
Operator
Thank you. Your next question comes from the line of Jami Rubin.
謝謝你。你的下一個問題來自 Jami Rubin。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Jami?
賈米?
Operator
Operator
Jami, please ask your question. Hello, Jami please ask your questions?
賈米,請問你的問題。你好,賈米請問你的問題?
Jami Rubin - Analyst
Jami Rubin - Analyst
Hello?
你好?
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Jami, you're on. Rose, we'll come back. Next question.
賈米,你在。羅斯,我們會回來的。下一個問題。
Operator
Operator
Thank you. Your next question comes from the line of Ronny Gal.
謝謝你。你的下一個問題來自 Ronny Gal。
Ronny Gal - Analyst
Ronny Gal - Analyst
Good morning, and thank you for taking my questions. I have three. First, you guys, as I think Umer mentioned, you've got a bit of a lower run rate on some commodity products, and you now have Anda as a differentiated distribution business. If we think about Teva's mix going forward, should we think about you kind of following the good old path, [Watson track], and having a lot more differentiated product, the commodity products, or are you kind of plotting a comeback on commodity product, as you bring more interesting products as well?
早上好,謝謝你回答我的問題。我有三個。首先,你們,正如我認為 Umer 提到的那樣,你們在某些商品上的運行率有點低,你們現在擁有 Anda 作為差異化分銷業務。如果我們考慮 Teva 的未來組合,我們是否應該考慮你遵循好的老路,[Watson track],並擁有更多差異化的產品,即商品,或者你是否正在策劃商品產品的捲土重來,您是否也帶來了更多有趣的產品?
Second question, looking at OUS generic, [Siggi], this feels like a good quarter to ask about the mix of gross profit between the US and OUS? You seem to have similar revenue numbers between the two. Can you just comment on the profitability, kind of like in rough sense between the US and OUS, when it comes to generic profits? Obviously, it will change a lot with Actavis, but would be good to see. And third, for I guess, a bit on the IP.
第二個問題,看看 OUS 仿製藥,[Siggi],這感覺是一個很好的季度來詢問美國和 OUS 之間的毛利潤組合?兩者之間的收入數字似乎相似。當涉及到通用利潤時,您能否評論一下盈利能力,有點像美國和 OUS 之間的粗略意義?顯然,它會隨著 Actavis 發生很大變化,但很高興看到。第三,我想,有點關於知識產權。
I noticed the last patent you listed, the 874 patent, which is I guess the last one to be resolved in terms of IP, that one looks very similar to the three patents which are under IPR, it terms of being dependent on the 3 times per week indication. Is this fair, that is, is this patent completely separate in terms of the decision, than the first three? Or frankly should we think about if the argument around 3 times per week gets overturned by the court or the IPR, we should think about 874 following track?
我注意到你列出的最後一個專利,874 專利,我猜這是最後一個在 IP 方面要解決的專利,那個看起來非常類似於 IPR 下的三個專利,它依賴於 3 倍每週指示。這是否公平,也就是說,與前三個相比,該專利在決定方面是否完全獨立?或者坦白的說,如果一周3次左右的爭論被法院或IPR推翻,我們應該考慮874跟風?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
So Ronny, maybe I'll start around the portfolio of the generics. I think clearly, with combination of Actavis Generics and Teva, we will have more differentiated portfolio. And with all the exclusive first-to-files that we are introducing over the next few years, there will be a movement there. But we will never be solely on that, because commodity generics will still play a big part.
所以羅尼,也許我會從仿製藥的產品組合開始。我清楚地認為,通過 Actavis Generics 和 Teva 的結合,我們將擁有更多差異化的產品組合。隨著我們在未來幾年推出的所有獨家先到文件,那裡將會有一場運動。但我們永遠不會只關注這一點,因為商品仿製藥仍將發揮重要作用。
Remember that because of TAPI, our own API, we can compete in the commodity much longer. Over 40% of our products have our own API in it, which is such a benefit to the long-livity of our portfolio, and we can still compete. But we also know that when there's many competitors in the market, and if we can't make a profitable business, we have no hesitation and focus on different. But we really think we can offer the whole range. As we have mentioned before, we're all the way from a very complex biologics specialty products to a commodity and everything between. But we really want to drive the overall portfolio, with a special emphasis on the more complex generics which we are extremely good at.
請記住,由於 TAPI,我們自己的 API,我們可以在商品中競爭更長時間。我們超過 40% 的產品中都有我們自己的 API,這對我們產品組合的長期生命力來說是一個很大的好處,我們仍然可以競爭。但我們也知道,當市場上競爭者眾多,無法盈利時,我們會毫不猶豫地專注於不同的領域。但我們真的認為我們可以提供整個系列。正如我們之前提到的,我們從非常複雜的生物製品專業產品到商品以及介於兩者之間的一切。但我們真的想推動整體產品組合,特別強調我們非常擅長的更複雜的仿製藥。
Eyal Desheh - CFO
Eyal Desheh - CFO
On the profitability of our generic pieces, obviously, we are not breaking this down, but what you've seen is that the level of profitability was similar to Q1, 26.8%. The difference from last year, mostly due to the three major products that saw a much more intensive competition in the US market. We're happy with the improvement in Europe, our European business showing very nice improvement in profitability, some uptick in the rest of the world. Other than that, the mix is not substantially changed.
關於我們仿製藥的盈利能力,顯然,我們並沒有對此進行細分,但你所看到的是,盈利水平與第一季度相似,為 26.8%。與去年不同的是,主要是由於三大產品在美國市場的競爭更加激烈。我們對歐洲的改善感到滿意,我們的歐洲業務在盈利能力方面表現出非常好的改善,在世界其他地區也有所上升。除此之外,組合沒有實質性改變。
Ronny Gal - Analyst
Ronny Gal - Analyst
But I guess, the question there is, if I have to think about revenue split between the three geographies, is it fair to say that operating profit split is roughly the same? Is the US more profitable, less profitable, just a ballpark of how the profits divide?
但我想,問題是,如果我必須考慮三個地區之間的收入分配,那麼說營業利潤分配大致相同是否公平?美國是利潤更高還是利潤更低,只是利潤分配的大致情況?
Erez Vigodman - CEO
Erez Vigodman - CEO
So rest of the world catching up, Ronny. There is one. Second, we see for us, huge opportunities at the end of the day. Most of the time, we focus on the US, but as a global generic business, we see huge opportunities ex-US. We have been expanding our opportunity in key growth markets and we'll continue to do that. We continue to grow the business, also outside of the US, and with increasing profitability out of the US will unlock more and more value.
所以世界其他地方正在迎頭趕上,羅尼。有一個。其次,我們最終會看到巨大的機遇。大多數時候,我們專注於美國,但作為一家全球仿製藥企業,我們看到了美國以外的巨大機遇。我們一直在擴大我們在關鍵增長市場的機會,我們將繼續這樣做。我們繼續發展業務,也在美國以外,隨著盈利能力的提高,美國以外的地區將釋放越來越多的價值。
David Stark - SVP, General Counsel, Global Markets & GSM
David Stark - SVP, General Counsel, Global Markets & GSM
Hey, Ronny, this is David. Thanks for the question. You're right that, that fifth patent is similar to some of the other patents that we have, but there are differences.
嘿,羅尼,這是大衛。謝謝你的問題。你是對的,第五項專利與我們擁有的其他一些專利相似,但也有區別。
This isn't the right forum to get into the details of what those differences are, which would touch on our litigation strategy. But I would also keep in mind, that what we might do going forward with the fifth patent, in particular, it's possible that could end up in front of a different panel at the PTAB, or even a different judge. And that could also lead to a different decision. So there are many variables in the mix.
這不是深入了解這些差異的詳細信息的合適論壇,這會觸及我們的訴訟策略。但我還要記住,我們可能會對第五項專利做些什麼,特別是,它可能最終會出現在 PTAB 的不同專家組面前,甚至可能出現在不同的法官面前。這也可能導致不同的決定。因此,混合中有很多變數。
Ronny Gal - Analyst
Ronny Gal - Analyst
Ah, got it. Thank you guys.
啊,明白了。感謝你們。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Rose?
玫瑰?
Operator
Operator
Thank you. Your next question comes from the line of Jami Rubin.
謝謝你。你的下一個問題來自 Jami Rubin。
Jami Rubin - Analyst
Jami Rubin - Analyst
Thank you. Can you guys hear me now?
謝謝你。你們現在能聽到我說話嗎?
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Yes.
是的。
Jami Rubin - Analyst
Jami Rubin - Analyst
Can you hear me? Okay, great. Thank you, apologies for that. Eyal, maybe can you explain what is going on in Venezuela? I saw that rest of world sales were up quite a bit, ahead of our expectations, and some of that was driven by sales in Venezuela. And in addition, other sales or OTC sales have benefited from the inflationary environment in Venezuela
你能聽到我嗎?好,太棒了。謝謝,對此深表歉意。 Eyal,也許你能解釋一下委內瑞拉的情況嗎?我看到世界其他地區的銷售額增長了很多,超出了我們的預期,其中一些是由委內瑞拉的銷售額推動的。此外,其他銷售或場外銷售也受益於委內瑞拉的通貨膨脹環境
I'm just wondering if you can, A, quantify what your revenues are, and just explain what's going on? Because it seems that every other company that we cover, certainly, large cap pharma, and other generics, have been writing down on that business, or getting out of it altogether, and while you're going in the other direction? So if you can talk about that? And secondly, can you, Eyal, tell us what you're assuming for the ProAir franchise going forward? I believe Perrigo will be launching a generic end of year, early next, and how we should think about revenues? Thanks.
我只是想知道你是否可以,A,量化你的收入是多少,然後解釋一下發生了什麼?因為似乎我們涵蓋的所有其他公司,當然,大型製藥公司和其他仿製藥,都在減記該業務,或者完全退出該業務,而您卻朝著另一個方向前進?那麼,如果你能談談這個?其次,Eyal,你能告訴我們你對 ProAir 特許經營權的未來假設嗎?我相信 Perrigo 將在年底、明年初推出通用產品,我們應該如何考慮收入?謝謝。
Eyal Desheh - CFO
Eyal Desheh - CFO
Okay. So on Venezuela. So Venezuela is [not] taking a big piece of our business, actually quarter after quarter, it's a bit down on sales and profit. Total sales, We will publish our full 6-K for the report later on today, our total sales were just above $200 million, split 50/50 between the generic sales and the OTC sales. Our profit contribution is not very high again, a bit down compared to what Q1 this year, a bit up compared to last year. So it doesn't really move the needle substantially right now.
好的。所以在委內瑞拉。所以委內瑞拉 [not] 佔據了我們業務的很大一部分,實際上一個季度又一個季度,它的銷售額和利潤有所下降。總銷售額,我們將在今天晚些時候發布完整的 6-K 報告,我們的總銷售額剛剛超過 2 億美元,仿製藥銷售額和非處方藥銷售額的比例為 50/50。我們的利潤貢獻又不是很高,比今年Q1低一點,比去年高一點。所以它現在並沒有真正大幅移動針頭。
Jami Rubin - Analyst
Jami Rubin - Analyst
Eyal, what's the outlook for that business? And how should we think about your treatment versus other companies?
Eyal,那家公司的前景如何?與其他公司相比,我們應該如何看待你們的待遇?
Eyal Desheh - CFO
Eyal Desheh - CFO
Well, one thing that differentiates us from most foreign companies that this pharma companies operating in Venezuela is that all our sales are produced locally. We don't import finished products, we have a plant that produces, this is a necessity in the country right now, and we are producing really essential drugs. The economy of Venezuela, this is neither the time and place to analyze, but we know that the economy there is not in good shape, to say the least, and we see what the future will bring. Lots of uncertainties, I wouldn't speculate on this either way.
嗯,這家在委內瑞拉經營的製藥公司與大多數外國公司不同的一件事是,我們所有的銷售都是在當地生產的。我們不進口成品,我們有一家生產的工廠,這是目前該國的必需品,我們正在生產真正必要的藥物。委內瑞拉的經濟,現在不是分析的時間和地點,但我們知道那裡的經濟狀況不佳,至少可以說,我們看到未來會帶來什麼。很多不確定性,我不會以任何一種方式推測這一點。
Sven Dethlefs - Head of Global Respiratory Medicines
Sven Dethlefs - Head of Global Respiratory Medicines
This is Sven, for the ProAir question. So ProAir has seen a slight growth in this quarter over last year, primarily driven by gross to net conversion. We have introduced the RespiClick, the new breath-actuated device into the ProAir franchise. We see a steady, but slow uptake.
我是 Sven,負責 ProAir 問題。因此,ProAir 在本季度比去年略有增長,這主要是受毛淨轉化率的推動。我們在 ProAir 系列中引入了 RespiClick,這是一種新的呼吸驅動裝置。我們看到穩定但緩慢的吸收。
We are round about a 3% market share in total prescription volume in the US so far with ProAir Respiclick. And we expect this trend to continue over the next month. Concerning the overall development of the franchise, I think we have to look at whether Perrigo gets, and when it gets the approval for the generic competitor to the ProAir HFA device that we have. Internally, we plan that we have a full generic entry, or let's say generic competition more towards the mid 2018 than in the near future.
到目前為止,ProAir Respicclick 在美國的總處方量中約佔 3% 的市場份額。我們預計這種趨勢將在下個月繼續。關於特許經營權的整體發展,我認為我們必須看看 Perrigo 是否獲得批准,以及何時獲得批准,成為我們擁有的 ProAir HFA 設備的通用競爭對手。在內部,我們計劃我們有一個完整的仿製藥進入,或者說仿製藥競爭更接近 2018 年年中而不是在不久的將來。
Jami Rubin - Analyst
Jami Rubin - Analyst
Thank you.
謝謝你。
Kevin Mannix - SVP & Head of Investor Relations
Kevin Mannix - SVP & Head of Investor Relations
Thank you, next question?
謝謝,下一個問題?
Operator
Operator
Thank you. Your next question comes from the line of Irina Koffler.
謝謝你。你的下一個問題來自 Irina Koffler。
Irina Koffler - Analyst
Irina Koffler - Analyst
Hi thank you for taking the question. There was nice growth on Treanda and Bendeka, and I was just wondering if there was any stocking this quarter? And also is Teva undertaking any additional activities to try to preserve Bendeka beyond 2019? Thank you.
嗨,謝謝你提出這個問題。 Treanda 和 Bendeka 的增長不錯,我只是想知道這個季度是否有庫存? Teva 是否正在開展任何額外的活動以試圖在 2019 年之後保護 Bendeka?謝謝你。
Eyal Desheh - CFO
Eyal Desheh - CFO
Yes, so on the businesses, yes, there was some stocking this quarter, once our customer realized that we won the a trial, and remain exclusive. So the regular run rate is a bit lower than what you see from Treanda. And Bendeka, we're happy to see a very nice conversion to Bendeka, over 80% right now. Beyond 2019, our settlements are September 2019.
是的,所以在業務上,是的,一旦我們的客戶意識到我們贏得了試用並保持獨家經營權,本季度就會有一些庫存。所以常規運行率比您從 Treanda 看到的要低一些。 Bendeka,我們很高興看到 Bendeka 的轉變非常好,現在超過 80%。 2019 年之後,我們的結算日期為 2019 年 9 月。
Erez Vigodman - CEO
Erez Vigodman - CEO
So it is not realistic to expect that we maintain the business beyond the end of 2019.
因此,期望我們在 2019 年底之後維持業務是不現實的。
Irina Koffler - Analyst
Irina Koffler - Analyst
Thank you.
謝謝你。
Operator
Operator
Thank you. Your next question comes from the line of Rohit Vanjani.
謝謝你。你的下一個問題來自 Rohit Vanjani。
Rohit Vanjani - Analyst
Rohit Vanjani - Analyst
Thanks for taking the question. I had a couple questions on the Copaxone litigation, and then one follow-up on the Anda acquisition. So when Mylan and Amneal initiated the IPR and PGR processes, was the fifth patent issued, the 874? And if not, would they still have to definitely invalidate that patent?
感謝您提出問題。我有幾個關於 Copaxone 訴訟的問題,然後是關於 Anda 收購的後續問題。那麼,當 Mylan 和 Amneal 啟動 IPR 和 PGR 流程時,是否發布了第五項專利,即 874?如果不是,他們是否仍然必須確定該專利無效?
David Stark - SVP, General Counsel, Global Markets & GSM
David Stark - SVP, General Counsel, Global Markets & GSM
So this is David speaking. The answer to the question is no. When they initiated the proceedings on those four patents, had not yet obtained the fifth patent, so the fifth patent recently listed in the Orange Book. And we haven't taken any action yet with respect to that.
這是大衛在說話。問題的答案是否定的。當他們對這四項專利提起訴訟時,第五項專利尚未獲得,因此第五項專利最近被列入橙皮書。我們還沒有對此採取任何行動。
Rohit Vanjani - Analyst
Rohit Vanjani - Analyst
And then, I know you said that if the PTAB invalidates on the three patents, it would be appealed to the Federal Circuit. But if Judge Sleet goes through the case, he can come to a different conclusion on those three patents correct, because he has a higher bar to clear? And he's the only one that can lift the 30 month stay, so in a sense he can (multiple speakers) sorry go ahead.
然後,我知道你說過,如果 PTAB 宣告這三項專利無效,它會上訴到聯邦巡迴法院。但如果 Sleet 法官審理此案,他可以對這三項專利得出不同的結論,因為他有更高的門檻要清除?而且他是唯一可以解除 30 個月停留期的人,所以從某種意義上說,他可以(多位發言者)抱歉繼續。
David Stark - SVP, General Counsel, Global Markets & GSM
David Stark - SVP, General Counsel, Global Markets & GSM
No, sorry. I didn't mean to cut you off there. Absolutely correct.
不,對不起。我不是故意打斷你的。完全正確。
Rohit Vanjani - Analyst
Rohit Vanjani - Analyst
Okay. So in a sense he can relitigate those three patents?
好的。那麼從某種意義上說,他可以重新起訴這三項專利嗎?
David Stark - SVP, General Counsel, Global Markets & GSM
David Stark - SVP, General Counsel, Global Markets & GSM
Yes.
是的。
Rohit Vanjani - Analyst
Rohit Vanjani - Analyst
Okay. And then on the Anda acquisition, do you know if, Siggi, they had a retailer alliance? And then, I know you said that it's no where near the big three, but can you grow it, and can you use it to offset some of the generics deflation?
好的。然後在收購 Anda 時,Siggi,你知道他們是否有零售商聯盟嗎?然後,我知道你說過它離三巨頭不遠,但你能發展它嗎,你能用它來抵消一些仿製藥的通貨緊縮嗎?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
So I think what -- how they do is, is they work with the independents more than anything else. And then, they are basically a support of the secondary to the primary accounts with the bigger. I don't know, obviously, we haven't closed the transaction, so we don't know the details about their contracts and things like that. But overall, obviously, throughout the years, knowing the business for the last six or seven years, it's a very steady business. It will not be a threat. You think about it, the third-party revenue is just in excess of $1 billion, so it's not a real threat to the big three.
所以我認為 - 他們的工作方式是,他們與獨立人士的合作比其他任何事情都多。然後,它們基本上是次要帳戶對較大帳戶的支持。我不知道,顯然,我們還沒有完成交易,所以我們不知道他們的合同等細節。但總的來說,很明顯,多年來,了解過去六七年的業務,這是一個非常穩定的業務。這不會構成威脅。你想一想,第三方的收入才剛剛超過10億美元,所以對三巨頭來說並不是真正的威脅。
I think what this gives us, is the flexibility, better service to all our customers, the big three, but also the independent. And a new way to get into the market is an opportunity when we have an exclusive launch, to get it to all of the pharmacies within 24 hours of launch. And all these added benefits, I think it's incrementally better for the business.
我認為這給我們帶來的是靈活性,為我們所有的客戶提供更好的服務,包括三巨頭,還有獨立的客戶。當我們獨家推出時,進入市場的新方式是一個機會,可以在推出後 24 小時內將其送到所有藥店。所有這些額外的好處,我認為它對企業來說會越來越好。
But it's also the next step in serving our customers better. But will it be a real threat to the big three, or can we grow it to tens of billions? That's not in the card. It's really the step of maintaining and serving our customers better than we do today.
但這也是更好地為客戶服務的下一步。但它會是對三巨頭的真正威脅,還是我們可以將其增長到數百億?那不在卡中。這實際上是比我們今天更好地維護和服務我們的客戶的步驟。
Rohit Vanjani - Analyst
Rohit Vanjani - Analyst
But as far as you know, they don't have a formalized alliance as AmerisourceBergen and Walgreens or McKesson and Rite Aide, or something like that?
但據您所知,他們沒有像 AmerisourceBergen 和 Walgreens 或 McKesson 和 Rite Aide 之類的正式聯盟?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
I don't know the answer to that question yet.
我還不知道那個問題的答案。
Rohit Vanjani - Analyst
Rohit Vanjani - Analyst
Okay, thanks.
好的謝謝。
Operator
Operator
Your next question comes from the line of Sumant Kulkarni.
你的下一個問題來自 Sumant Kulkarni。
Sumant Kulkarni - Analyst
Sumant Kulkarni - Analyst
Thanks for taking my questions, I have three quick ones. First, Teva by itself was quite large in terms of facilities. Now that you've had the keys for a couple days, could you give us an update on the rationalization of facilities? And is it fair to assume the $[1.4 billion] in synergy does not assume anything major there? Second, in the new Teva generics side, is there still anything you're relatively less strong in terms of capabilities, that buying might be more efficient than building? And third, could you rank order your prioritization of biosimilars within the $3 billion to $4 billion of business development dollars that you set aside?
感謝您提出我的問題,我有三個快速的問題。首先,就設施而言,Teva 本身就相當大。現在你已經拿到鑰匙幾天了,你能給我們介紹一下設施合理化的最新情況嗎?並且假設 14 億美元的協同作用沒有假設任何重大事件是否公平?其次,在新的 Teva 仿製藥方面,是否還有什麼你在能力方面相對不那麼強,購買可能比構建更有效率的東西?第三,在您預留的 30 億至 40 億美元的業務發展資金中,您能否對生物仿製藥的優先順序進行排序?
Siggi Olafsson - President & CEO, Global Generic Medicines
Siggi Olafsson - President & CEO, Global Generic Medicines
Yes, so let me start. So the overall as we mentioned the $1.4 billion of cost and tax synergies, we didn't identify any new facility. What we mentioned was, a decision that had been taken in Teva, independently of the transaction, and have been taken in Actavis independently of the transaction, we're going ahead with those movements. But overall, any synergy movement, closing of the facility, no decisions have been made. And they are not included in the $1.4 billion.
是的,讓我開始吧。因此,正如我們提到的 14 億美元的成本和稅收協同效應,我們沒有發現任何新設施。我們提到的是,梯瓦獨立於交易做出的決定,以及阿特維斯獨立於交易做出的決定,我們將繼續這些行動。但總的來說,任何協同行動、關閉設施,都沒有做出任何決定。而且它們不包括在 14 億美元中。
Because also you need to keep in mind, from the time we announce a closure, or decide to close a facility, until we see a benefit, is more than three years. So overall, it's not built into that plan. Obviously, we will look at it. We have a lot of facilities, over 80 manufacturing plants around the world. So there might be something we look at, but there's no decisions being made, since we signed on any future further facility closures.
因為你還需要記住,從我們宣布關閉或決定關閉設施,到我們看到收益,已經超過三年了。所以總的來說,它沒有納入該計劃。顯然,我們會看看它。我們有很多設施,在世界各地有 80 多家製造廠。所以我們可能會考慮一些事情,但還沒有做出任何決定,因為我們簽署了任何未來進一步關閉設施的協議。
With regards to the new generic business, where it might make sense to buy instead of build, you in a way answered that in your third question. I think biosimilars, is probably the point where it might make sense to buy something, instead of building it from ground up. We are obviously looking into that.
關於新的通用業務,購買而不是構建可能更有意義,您在第三個問題中以某種方式回答了這個問題。我認為生物仿製藥可能是購買某種東西而不是從頭開始構建它可能有意義的地方。我們顯然正在調查這一點。
In terms of other dosage forms, I think we really are covering the whole range, from anything from a very complex injectable where Teva has been the leader, in terms of slow release injectables, in terms of proteins, in terms of delivery system, all the way to patches, semi solids, liquids that Actavis has been the leader in, and really everything in between there. But clearly, where we are lagging behind is, is on the biosimilars where our pipeline is quite thin for the short-term. But clearly for the long-term, when we talk about Wave 3 after 2021 we have a very exciting pipeline that we are working on. And on the BD front for biosimilars?
就其他劑型而言,我認為我們確實涵蓋了整個範圍,從梯瓦一直處於領先地位的非常複雜的注射劑,在緩釋注射劑方面,在蛋白質方面,在輸送系統方面,所有Actavis 一直處於領先地位的補丁、半固體、液體的方式,以及介於兩者之間的所有東西。但很明顯,我們落後的地方是生物仿製藥,我們的管道在短期內非常薄弱。但很明顯,從長遠來看,當我們談論 2021 年後的第三波時,我們正在研究一個非常令人興奮的管道。在生物仿製藥的 BD 前沿?
Erez Vigodman - CEO
Erez Vigodman - CEO
So we don't rule out the possibility of a potential acquisition of biosimilar assets or activities. We are assessing the landscape. And with the right one, we might entertain a deal.
因此,我們不排除潛在收購生物仿製藥資產或活動的可能性。我們正在評估景觀。如果選對了,我們可能會達成一筆交易。
Sumant Kulkarni - Analyst
Sumant Kulkarni - Analyst
Thank you.
謝謝你。
Operator
Operator
Thank you. I would now like to hand the conference back over to Erez Vigodman, President and CEO for final remarks.
謝謝你。我現在想將會議交還給總裁兼首席執行官 Erez Vigodman 以作最後發言。
Erez Vigodman - CEO
Erez Vigodman - CEO
So thank you for joining us today, and have a great day.
所以感謝你今天加入我們,祝你有美好的一天。
Operator
Operator
Thank you, ladies and gentlemen for participating today. For those of you wishing to review this conference, the replay facility can be accessed by dialing within the UK, on 0845-245-5205, or alternatively on the country code of plus 44-1452- 550000, and the reservation number is 52122137.
女士們,先生們,謝謝你們今天的參與。對於那些希望回顧這次會議的人,可以通過在英國境內撥打 0845-245-5205 或國家代碼加 44-1452-550000 來訪問重播設施,預訂號碼是 52122137。