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Operator
Operator
Thank you for standing by, and welcome to the Teva Pharmaceuticals Third Quarter 2017 Financial Results Webcast.
感謝您的支持,歡迎收聽梯瓦製藥 2017 年第三季度財務業績網絡廣播。
(Operator Instructions) I must advise you the webcast is being recorded today, Thursday, the 2nd of November 2017.
(操作員說明)我必須告訴您,今天,星期四,2017 年 11 月 2 日,正在錄製網絡廣播。
I would now like to hand the webcast over to your first speaker today, Kevin Mannix, Senior Vice President of Investor Relations.
我現在想將網絡直播交給您今天的第一位發言人,投資者關係高級副總裁 Kevin Mannix。
Please go ahead, sir.
請繼續,先生。
Kevin C. Mannix - Head of Global IR
Kevin C. Mannix - Head of Global IR
Thank you, Kalem.
謝謝你,卡萊姆。
And thank you, everyone, for joining us today to discuss Teva's Third Quarter 2017 Financial Results.
感謝大家今天加入我們討論梯瓦公司 2017 年第三季度財務業績。
On the call with us today are Dr. Sol Barer, Chairman of the Board; Kåre Schultz, our President and CEO; Dr. Yitzhak Peterburg, our outgoing CEO; Mike McClellan, Interim Chief Financial Officer; Dipankar Bhattacharjee, Global Generic Medicines; Dr. Rob Koremans, Global Specialty Medicines; Dr. Michael Hayden, Global R&D Chief Scientific Officer; Hafrun Fridriksdottir, Global Generics R&D; Dr. Carlo De Notaristefani, Global Operations; and David Stark, Chief Legal Officer.
今天與我們通話的是董事會主席 Sol Barer 博士; Kåre Schultz,我們的總裁兼首席執行官;我們即將離任的首席執行官 Yitzhak Peterburg 博士; Mike McClellan,臨時首席財務官; Dipankar Bhattacharjee,全球仿製藥; Rob Koremans 博士,全球特種藥物;全球研發首席科學官 Michael Hayden 博士; Hafrun Fridriksdottir,全球仿製藥研發;全球運營部 Carlo De Notarisefani 博士;和首席法務官大衛·斯塔克。
We will start the call, which will last approximately one hour, with a review of the quarter and revised 2017 outlook by Yitzhak and Mike followed by remarks from Kåre and Sol.
我們將開始電話會議,這將持續大約一個小時,由 Yitzhak 和 Mike 回顧季度並修訂 2017 年展望,隨後來自 Kåre 和 Sol 的評論。
We'll then open the call up for questions and answers.
然後,我們將打開電話詢問問題和答案。
Please note that Kåre will not be participating in today's question-and-answer session.
請注意,Kåre 不會參加今天的問答環節。
A copy of the slides of the presentation can be found on our website at www.tevapharm.com as well as on our Teva Investor Relations app.
演示幻燈片的副本可在我們的網站 www.tevapharm.com 以及我們的 Teva 投資者關係應用程序上找到。
During this call, we'll be making forward-looking statements, which are predictions, projections or other statements about future events.
在本次電話會議中,我們將做出前瞻性陳述,即對未來事件的預測、預測或其他陳述。
These estimates reflect management's current expectations for Teva's performance.
這些估計反映了管理層目前對梯瓦(Teva)業績的預期。
Actual results may vary, whether as a result of exchange rate differences, market conditions or other factors.
實際結果可能因匯率差異、市場條件或其他因素而有所不同。
In addition, the non-GAAP figures exclude the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step up, legal settlements and reserves, impairments and related tax effects.
此外,非公認會計原則數據不包括購買的無形資產的攤銷、與某些監管行動相關的成本、庫存增加、法律結算和準備金、減值和相關的稅收影響。
The non-GAAP data represented by Teva are used by Teva's management and Board of Directors to evaluate the operational performance of the company to compare against the company's work plans and budgets, and ultimately, to evaluate the performance of management.
Teva 代表的非 GAAP 數據被 Teva 的管理層和董事會用來評估公司的運營績效,以與公司的工作計劃和預算進行比較,並最終評估管理層的績效。
Teva provides such non-GAAP data to investors as a supplement of data and not in substitution or replacement for GAAP results.
Teva 向投資者提供此類非 GAAP 數據作為數據的補充,而不是替代或替代 GAAP 結果。
Because management believes such data provides useful information to investors.
因為管理層認為這些數據為投資者提供了有用的信息。
And with that, I will now turn the call over to Yitzhak.
有了這個,我現在將把電話轉給伊扎克。
Yitzhak, please.
伊扎克,請。
Yitzhak Peterburg
Yitzhak Peterburg
Thank you, Kevin, and hello, everyone.
謝謝你,凱文,大家好。
I would like to start by offering a very warm welcome to Kåre.
首先,我要熱烈歡迎 Kåre。
In just a few minutes, Mike will provide a thorough overview of our third quarter results and outlook for the remainder of the year.
在短短幾分鐘內,邁克將全面概述我們第三季度的業績和今年剩餘時間的前景。
Over the past 9 months, it has been an honor to serve as Teva interim CEO, especially, during such a challenging period.
在過去的 9 個月裡,擔任 Teva 臨時首席執行官是我的榮幸,尤其是在這樣一個充滿挑戰的時期。
I am -- very much appreciated having the full support of Sol, my fellow Board directors and the entire management team to take the necessary, important, and in some cases, very tough measures to help bring Teva back on track.
我非常感謝 Sol、我的董事會董事和整個管理團隊的全力支持,以採取必要的、重要的、在某些情況下非常艱難的措施來幫助 Teva 重回正軌。
I'm pleased with the progress we have made to date on key assets in our specialty pipeline, which included the approvals and launches of AUSTEDO for the treatment of chorea associated with Huntington's disease and tardive dyskinesia in adults.
我對迄今為止我們在專業管道中的關鍵資產方面取得的進展感到高興,其中包括 AUSTEDO 的批准和推出,用於治療與亨廷頓病相關的舞蹈症和成人遲發性運動障礙。
We also took measures to expedite the review of our recently submitted BLA for fremanezumab in anti-CGRP monoclonal antibody.
我們還採取措施加快了對我們最近提交的用於抗 CGRP 單克隆抗體中 fremanezumab 的 BLA 的審查。
During the quarter, we acquired a U.S. FDA priority review voucher to allow us to accelerate the review time for fremanezumab, which, if approved, will be among one of the very first to enter the market in a new class of drugs for the preventive treatment of migraine.
在本季度,我們獲得了美國 FDA 優先審查憑證,以加快對 fremanezumab 的審查時間,如果獲得批准,它將成為首批進入市場的新型預防性治療藥物之一偏頭痛。
We are thrilled about the potential to make this therapy available to the millions of people around the world who live with the debilitating effects of migraine.
我們很高興有可能將這種療法提供給世界各地數以百萬計的偏頭痛患者。
These achievements also represent an important part of the company's ongoing efforts to address the erosion of our largest product COPAXONE due to generic filers.
這些成就也代表了公司為解決我們最大的產品 COPAXONE 因仿製藥文件而受到侵蝕的持續努力的重要組成部分。
This erosion accelerated significantly last month following a competitor's approval and the launch of a generic COPAXONE 40-milligram in the U.S. We have been preparing for this transition through our investment in geographical products and pipeline diversification and this investment will certainly take time to bear fruit and to begin to contribute steadily to our cash flow.
在競爭對手獲得批准並在美國推出 40 毫克仿製藥 COPAXONE 後,這種侵蝕在上個月顯著加速。我們一直在通過對地理產品和管道多元化的投資為這一過渡做準備,這項投資肯定需要時間才能取得成果和開始穩定地為我們的現金流做出貢獻。
We've also moved forward with the divestitures of several products and businesses, including yesterday's completed sale of PARAGARD and soon to follow Plan B One-Step to allow us to progress the repayment of our debt.
我們還推進了多項產品和業務的剝離,包括昨天完成的 PARAGARD 出售以及很快遵循 B 計劃的一步,以使我們能夠推進債務的償還。
We have now signed contract to divest noncore assets that will generate approximately $2.3 billion in net proceeds with the majority expected to be collected in 2017.
我們現在已經簽署了剝離非核心資產的合同,這些資產將產生約 23 億美元的淨收益,其中大部分預計將在 2017 年收回。
I truly believe that Teva possesses unique capabilities and strengths that can serve as tremendous assets, while it looks to meet the demands of an evolving global health care industry.
我堅信 Teva 擁有獨特的能力和優勢,可以作為巨大的資產,同時它希望滿足不斷發展的全球醫療保健行業的需求。
I believe that the company will be able to step out of this situation as a better and stronger company, and it will do that under the leadership of Kåre, who I wish every success in the future.
我相信公司將能夠走出困境,成為一家更好、更強大的公司,並在 Kåre 的領導下做到這一點,我祝愿他未來一切順利。
I'm looking forward to working with Kåre as a member of our Board, where I now return to.
我期待著作為我們董事會成員與 Kåre 一起工作,我現在又回到了那裡。
Thank you all.
謝謝你們。
It has been a privilege.
這是一種特權。
I will now turn the call over to Mike to provide more insight into the numbers.
我現在將把電話轉給 Mike,以提供對這些數字的更多見解。
Mike?
麥克風?
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
Thank you, Yitzhak.
謝謝你,伊扎克。
Good morning, everyone, and please join me as we review the results of the third quarter.
大家早上好,請和我一起回顧第三季度的業績。
So revenues this quarter were $5.6 billion, up 1% compared to Q3 of 2016.
因此,本季度的收入為 56 億美元,比 2016 年第三季度增長 1%。
While we had another month of Actavis quarter as well as the revenues of ANDA, which was consolidated in Q4 2016.
雖然我們還有一個月的阿特維斯季度以及 ANDA 的收入,但在 2016 年第四季度合併。
There have been continued headwinds in the generic business, while our specialty business was impacted by the loss of exclusivity of several products.
仿製藥業務一直面臨逆風,而我們的專業業務則受到失去幾種產品的排他性的影響。
We'll dive into the revenue trends in the coming slides.
我們將在接下來的幻燈片中深入探討收入趨勢。
On a non-GAAP basis, operating income was $1.5 billion, resulting in $1 EPS; while on a GAAP basis, operating income was $0.4 billion and EPS was $0.52.
按非公認會計原則計算,營業收入為 15 億美元,每股收益為 1 美元;而按公認會計原則計算,營業收入為 4 億美元,每股收益為 0.52 美元。
As in Q1 and Q2 of this year, the effect of our mandatory convertible preferred shares was anti-dilutive.
與今年第一季度和第二季度一樣,我們的強制性可轉換優先股的影響是反稀釋的。
So the number of shares remains at $1,017,000,000.
因此,股票數量保持在 1,017,000,000 美元。
Now focusing on our non-GAAP P&L for the quarter.
現在專注於我們本季度的非公認會計原則損益。
Operating income is down 18% and EPS is down 24%.
營業收入下降 18%,每股收益下降 24%。
The profitability of the company was down to 26.2% from 32.2% in 2016 Q3.
公司的盈利能力從 2016 年第三季度的 32.2% 下降至 26.2%。
This reflects a lower gross profit of 53% in the quarter compared to 61% in the same quarter of the previous year.
這反映出本季度毛利潤為 53%,低於去年同期的 61%。
This is driven by several factors.
這是由幾個因素驅動的。
The inclusion of ANDA distribution business as well as lower margins in the generics, specifically, in our U.S. generic market.
包括 ANDA 分銷業務以及仿製藥的較低利潤率,特別是在我們的美國仿製藥市場。
This was partially offset by reductions in expenses, mainly in our R&D and sales and marketing.
這部分被費用的減少所抵消,主要是在我們的研發、銷售和營銷方面。
Our cash flow from operations was over $1 billion, landing at $1.1 billion in Q3 2017.
我們的運營現金流超過 10 億美元,在 2017 年第三季度達到 11 億美元。
And this quarter had no significant one-time payments as we had seen in the first half of the year.
正如我們在今年上半年看到的那樣,本季度沒有重大的一次性付款。
For non-GAAP adjustments for the quarter, they were just under $0.5 billion net.
對於本季度的非公認會計原則調整,它們的淨額略低於 5 億美元。
We had impairments of over $400 million, mostly relating to assets acquired as part of Actavis.
我們有超過 4 億美元的減值,主要與作為 Actavis 的一部分收購的資產有關。
Amortization expenses were $357 million, which is in line with our current run rate.
攤銷費用為 3.57 億美元,與我們目前的運行速度一致。
During the quarter, we also acquired an FDA priority review voucher as mentioned by Yitzhak, which will allow us to accelerate the review time of fremanezumab, one of our key specialty assets for the treatment of migraine.
在本季度,我們還獲得了 Yitzhak 提到的 FDA 優先審查憑證,這將使我們能夠加快 fremanezumab 的審查時間,這是我們治療偏頭痛的關鍵專業資產之一。
You can see it here as an R&D expense.
您可以在這裡將其視為研發費用。
Finally, this quarter, we utilized historic capital losses related to the Actavis acquisition, resulting in a large -- unusually large tax effect in our non-GAAP adjustments.
最後,本季度,我們利用了與收購阿特維斯相關的歷史性資本損失,從而在我們的非公認會計原則調整中產生了巨大的——異常巨大的稅收影響。
Starting with the balance sheet.
從資產負債表開始。
Total assets at September 30 were $86.1 million, a slight reduction from June 30.
9 月 30 日的總資產為 8610 萬美元,比 6 月 30 日略有減少。
The largest move was an increase in other current assets, reflecting the transfer of the assets related to our Women's Health business into a held-for-sale position.
最大的變動是其他流動資產的增加,反映了與我們的女性健康業務相關的資產轉移到持有待售的位置。
This includes an allocation of goodwill following the announcement of the upcoming divestments of these assets.
這包括在宣布即將剝離這些資產後分配商譽。
As you may have seen yesterday, we closed on the first of these divestments with PARAGARD.
正如您昨天可能已經看到的那樣,我們通過 PARAGARD 完成了第一次撤資。
On the liability side, as of September 30, 2017, our debt was $34.7 billion compared to $35.1 billion at June 30, 2017.
在負債方面,截至 2017 年 9 月 30 日,我們的債務為 347 億美元,而 2017 年 6 月 30 日為 351 億美元。
The decrease was mainly due to $600 million of debt repayments on our 5-year term loan, our revolving credit facility and other short-term loans, partially offset by foreign exchange fluctuations on our euro-based bonds, which raise the debt by $200 million.
減少的主要原因是我們償還了 6 億美元的 5 年期定期貸款、循環信貸額度和其他短期貸款,部分被我們以歐元為基礎的債券的外匯波動所抵消,這使債務增加了 2 億美元.
8% of our debt is now classified as short-term compared to 4% at June 30, 2017, mainly due to changes in the current portion of our long-term debt.
我們現在將 8% 的債務歸類為短期債務,而 2017 年 6 月 30 日這一比例為 4%,這主要是由於我們長期債務的流動部分發生了變化。
Foreign exchange impacts -- impacted our results with the exception of the Venezuela bolivar were positive on the top line and negligible on operating income.
外匯影響——影響了我們的業績,但委內瑞拉玻利瓦爾的收入為正,營業收入可忽略不計。
In the third quarter of 2017, we continue to update the exchange rate we used to translate results in Venezuela and decided to use the DICOM rate of 3,345 bolivar per dollar, which is not materially different from the blended rate we calculated internally.
在 2017 年第三季度,我們繼續更新我們用於轉換委內瑞拉結果的匯率,並決定使用 DICOM 匯率 3,345 玻利瓦爾兌美元,這與我們內部計算的混合匯率沒有重大差異。
This resulted in the decrease of $243 million in revenues and $25 million in GAAP operating income and $15 million in non-GAAP operating income compared to the previous quarter of 2016.
與 2016 年上一季度相比,這導致收入減少 2.43 億美元,GAAP 營業收入減少 2500 萬美元,非 GAAP 營業收入減少 1500 萬美元。
In light of political and economic conditions in Venezuela, we exclude these changes in revenues and operating profit from any discussion of local currency results.
鑑於委內瑞拉的政治和經濟狀況,我們將收入和營業利潤的這些變化排除在對當地貨幣結果的討論之外。
Our Q3 EBITDA was $1.63 billion and EBITDA for the last 4 quarters now amounts to $7.3 billion.
我們的第三季度 EBITDA 為 16.3 億美元,過去 4 個季度的 EBITDA 現在達到 73 億美元。
Cash flow: As mentioned previously, this quarter cash flow amounted to $1.1 billion as we had no exceptional payments in this quarter.
現金流量:如前所述,本季度現金流量為 11 億美元,因為我們在本季度沒有特殊付款。
In the first half of the year, I remind you that we had approximately $1 billion of payments, including $0.5 billion for our FCPA settlements, $250 million for the final settlement of certain hedging transactions and $225 million related to the ciprofloxacin settlement.
在今年上半年,我提醒您,我們大約有 10 億美元的付款,其中 5 億美元用於我們的 FCPA 和解,2.5 億美元用於某些對沖交易的最終結算,以及與環丙沙星和解相關的 2.25 億美元。
Looking at our liquidity measures.
看看我們的流動性措施。
While debt is reducing slowly, offset by some headwinds in the currency impact, this quarter's EBITDA is lower than that of Q3 2016, resulting in a net debt-to-EBITDA ratio of 4.7, up slightly from the 4.57 last quarter.
雖然債務正在緩慢減少,但被貨幣影響的一些不利因素所抵消,但本季度的 EBITDA 低於 2016 年第三季度,導致淨債務與 EBITDA 的比率為 4.7,略高於上一季度的 4.57。
Leverage, however, decreased slightly to 53%.
然而,槓桿率略微下降至 53%。
Now getting into the quarterly revenues.
現在進入季度收入。
We saw an increase of 1% quarter-over-quarter, made up of a number of movements.
我們看到季度環比增長 1%,由許多變動組成。
First of all, U.S. generics revenues were down $102 million, despite the increase of an additional month of the Actavis generics compared to the same quarter in 2016.
首先,儘管阿特維斯仿製藥與 2016 年同期相比增加了一個月,但美國仿製藥收入下降了 1.02 億美元。
The U.S. business was impacted from continued price erosion, which was 10% in Q3 2017 on the base business as compared to the same quarter of last year as well as accelerated FDA approvals of additional generic versions of competitors in our base business as well as lower volumes of the Concerta-authorized generic following additional competition.
美國業務受到持續價格侵蝕的影響,與去年同期相比,2017 年第三季度基礎業務的價格下降了 10%,以及 FDA 加速批准我們基礎業務中競爭對手的其他仿製藥版本以及更低的價格。在額外的競爭之後,Concerta 授權的仿製藥捲。
Our EU and Rest of the World's generics, excluding Venezuela, were up slightly due to organic growth and an extra month of the Actavis acquisition compared to 2016 Q3.
與 2016 年第三季度相比,由於有機增長和對阿特維斯的額外一個月收購,我們的歐盟和世界其他地區(不包括委內瑞拉)的仿製藥略有上漲。
I'll address COPAXONE separately in a minute.
我將在一分鐘內單獨討論 COPAXONE。
But our other specialty products increased $47 million due to strong performance in our respiratory and oncology franchises, partially offset by the loss of exclusivity of AZILECT.
但由於我們的呼吸和腫瘤專營權的強勁表現,我們的其他專業產品增加了 4700 萬美元,部分被 AZILECT 排他性的喪失所抵消。
Other revenues were up $300 million, mainly reflecting the inclusion of ANDA business, which was consolidated first in Q4 of 2016.
其他收入增加了 3 億美元,主要反映了 ANDA 業務的加入,該業務於 2016 年第四季度首次合併。
Currency fluctuations, particularly, the euro, resulted in the slight increase in sales, which was more than offset by the devaluation in Venezuela that I just discussed, resulting in a net decrease of revenues by $169 million.
貨幣波動,尤其是歐元,導致銷售額略有增加,這被我剛才討論的委內瑞拉貶值所抵消,導致收入淨減少 1.69 億美元。
So for COPAXONE, revenues were almost $1 billion in Q3 2017, which is a decrease of 7% compared to the third quarter of 2016.
因此,對於 COPAXONE,2017 年第三季度的收入接近 10 億美元,與 2016 年第三季度相比下降了 7%。
The revenues were down 7%, mainly due to lower sales in the U.S., impacted by a $55 million increase in managed care rebate accruals for the inventory in the channel at September 30, following the FDA approval of a generic competition to COPAXONE 40-milligram, and in addition, we had lower volumes of COPAXONE 20-milligram compared to 2016.
收入下降 7%,主要是由於美國的銷售額下降,受到 FDA 批准與 COPAXONE 40 毫克的仿製藥競爭後,9 月 30 日渠道庫存的管理式護理回扣應計增加 5500 萬美元的影響,此外,與 2016 年相比,我們的 COPAXONE 20 毫克的數量有所減少。
In terms of geographies, in which we generate our income, The United States generates slightly more than 50% of our revenues, in line with the results of last year.
就我們產生收入的地區而言,美國產生了略高於我們收入的 50%,與去年的結果一致。
Europe was up slightly to 27%, while the Rest of the World markets generated 20% of our revenues, down from 23% influenced heavily by the Venezuela devaluation.
歐洲略微上升至 27%,而世界其他地區市場為我們創造了 20% 的收入,低於受委內瑞拉貨幣貶值嚴重影響的 23%。
Compared to this quarter of Q3 2016, the share of other revenues has increased from 4% to 10%, following the inclusion of ANDA.
與 2016 年第三季度相比,在加入 ANDA 之後,其他收入的份額從 4% 增加到 10%。
Specialty accounted for 36% and generics was down to 54%.
專業佔 36%,仿製藥下降到 54%。
For the quarterly non-GAAP operating profit, we are down overall 18%.
對於季度非公認會計原則營業利潤,我們整體下降了 18%。
The largest decrease was in the profit of our generics business, mainly due to lower revenues and margins in the U.S. COPAXONE revenues and profit were down slightly based on the discussion I just had.
最大的下降是我們的仿製藥業務的利潤,主要是由於美國 COPAXONE 的收入和利潤率下降,根據我剛才的討論,COPAXONE 的收入和利潤略有下降。
And the profit of our other specialty products increased by $109 million due to higher revenues and significant cost-savings.
由於更高的收入和顯著的成本節約,我們其他特種產品的利潤增加了 1.09 億美元。
Financial outlook: Today, we are updating our full year guidance, expecting revenues of $22.2 billion to $22.3 billion, EPS between $3.77 and $3.87 and cash flow of $3.15 billion to $3.3 billion.
財務展望:今天,我們正在更新全年指引,預計收入為 222 億美元至 223 億美元,每股收益在 3.77 美元至 3.87 美元之間,現金流量為 31.5 億美元至 33 億美元。
Our 2017 financial outlook was lower to reflect the following events.
我們的 2017 年財務展望較低,以反映以下事件。
An earlier-than-expected at-risk launch of a generic competitor to COPAXONE 40-milligram with an expected impact on EPS of approximately $0.30.
COPAXONE 40 毫克仿製藥競爭對手的上市風險早於預期,預計對每股收益的影響約為 0.30 美元。
In addition, we have lower-than-expected contribution from new generic launches in the U.S. We now project approximately $400 million of revenues from new product launches this year compared to a previous projection of $500 million.
此外,我們在美國推出的新仿製藥的貢獻低於預期。我們現在預計今年新產品推出的收入約為 4 億美元,而之前的預測為 5 億美元。
In addition, we have increased price erosion and volume declines in our U.S. generic business, including increased competition to our largest product, the Concerta-authorized generic.
此外,我們增加了美國仿製藥業務的價格侵蝕和銷量下降,包括對我們最大的產品 Concerta 授權仿製藥的競爭加劇。
In addition, we have a lower cash flow from operations due to the reduction in net income as well as a delay in our resolution of our working capital dispute with Allergan, which is now scheduled to conclude in 2018 instead of Q4 2017.
此外,由於淨收入減少以及我們與艾爾建 (Allergan) 的營運資金糾紛的解決延遲,我們的運營現金流量較低,該糾紛現在定於 2018 年而不是 2017 年第四季度結束。
At this point, I'd like to turn it back over to Kevin Mannix.
在這一點上,我想把它交給 Kevin Mannix。
Kevin C. Mannix - Head of Global IR
Kevin C. Mannix - Head of Global IR
Thanks, Mike.
謝謝,邁克。
We're just going to have some remarks from our CEO, Kåre Schultz, followed by remarks from our Chairman, Sol Barer.
我們的首席執行官 Kåre Schultz 將發表一些講話,然後我們的董事長 Sol Barer 將發表講話。
Kåre, please.
卡雷,請。
Kåre Schultz - President, CEO & Director
Kåre Schultz - President, CEO & Director
Thank you, Kevin.
謝謝你,凱文。
I'm pleased to be here and I would like to start by saying, I look forward to getting to know Teva shareholders and analysts so that we can have an open dialogue about Teva's progress in future.
我很高興來到這裡,首先我想說的是,我期待認識 Teva 的股東和分析師,以便我們可以就 Teva 未來的進展進行公開對話。
I have long admired Teva as a leader in the pharmaceutical industry.
我一直欽佩梯瓦製藥作為製藥行業的領導者。
What drew me to this company and what makes Teva unique amongst its peers is its relentless commitment to developing medicines that help millions of people around the world lead better, healthier lives every day.
吸引我加入這家公司以及 Teva 在同行中的獨特之處在於它不懈地致力於開發藥物,幫助全世界數百萬人每天過上更好、更健康的生活。
Teva has achieved an extensive global footprint while continuing to build on the Israeli culture that has served as its foundation for over a century.
Teva 已在全球範圍內取得了廣泛的影響,同時繼續建立一個多世紀以來一直作為其基礎的以色列文化。
I'm confident that the promise of Teva's specialty pipeline covered with the disciplined focus on executing key generic launches and the strength and scale of operations will allow Teva to compete successfully as the global pharmaceutical industry continues to evolve.
我相信,隨著全球製藥行業的不斷發展,Teva 的專業產品線的承諾以及對執行關鍵仿製藥的嚴格關注以及運營的實力和規模將使 Teva 能夠成功地競爭。
I've spent most of my 30-year career overseeing both generic and specialty product portfolios.
在我 30 年的職業生涯中,我大部分時間都在監督通用和特殊產品組合。
I am familiar with the ins and outs of the manufacturing footprint and development pipeline this entails.
我熟悉這需要的製造足跡和開發管道的來龍去脈。
But, of course, will need to study Teva's operation closely at first hand.
但是,當然,需要親身仔細研究 Teva 的運營情況。
We need to build on the company's ongoing efforts to strengthen operations, improve financial performance and reposition Teva operationally and financially.
我們需要在公司持續努力的基礎上加強運營,改善財務業績,並在運營和財務上重新定位梯瓦。
I recognize the significant debt burden that Teva is currently under.
我認識到梯瓦目前所承受的巨大債務負擔。
And it will be an absolute priority for me that we stabilize the company's operating profit and cash flow in order to improve our financial profile.
對我來說,穩定公司的營業利潤和現金流以改善我們的財務狀況將是絕對優先事項。
Although I'm not participating in the Q&A today, I do look forward to speaking with you and answering your questions at the appropriate time.
雖然我今天沒有參加問答環節,但我很期待在適當的時候與您交談並回答您的問題。
With that, I will now pass the call to Sol.
有了這個,我現在將把電話轉給 Sol。
Sol J. Barer - Chairman of the Board
Sol J. Barer - Chairman of the Board
Thank you, Kåre, and thank you to everyone for joining us today.
謝謝你,Kåre,也感謝大家今天加入我們。
Before we move to Q&A, I wanted to share some personal reflections accumulated over the 10 months that I have had since my appointment as Chairman of Teva.
在進入問答環節之前,我想分享一些自被任命為 Teva 董事長以來的 10 個月中積累的個人感想。
I've shared with you my deep commitment to the company and the measures we would carry out to transform Teva.
我已經與您分享了我對公司的堅定承諾以及我們為改造梯瓦(Teva)將採取的措施。
Since then we have taken steps, including, strengthening our Board by welcoming 4 world-class directors, whose wisdom and expertise are already adding great value.
從那時起,我們採取了一些措施,包括通過歡迎 4 位世界級董事來加強我們的董事會,他們的智慧和專業知識已經為我們帶來了巨大的價值。
We also conducted a thorough search, did not compromise, and ultimately, we found the right CEO for Teva, today marks the beginning of the next chapter for our company.
我們還進行了徹底的搜索,沒有妥協,最終,我們為 Teva 找到了合適的 CEO,今天標誌著我們公司下一章的開始。
I would like to emphasize how pleased we are to welcome Kåre to Teva as our new CEO.
我想強調一下,我們非常高興地歡迎 Kåre 加入 Teva 擔任我們的新任 CEO。
Kåre is a seasoned veteran in the health care industry.
Kåre 是醫療保健行業的資深人士。
Over the course of his 30-year career, he has developed a unique perspective, overseeing generic and specialty drug portfolios, while managing complex business operations around the world.
在他 30 年的職業生涯中,他形成了獨特的視角,負責監督仿製藥和特種藥物組合,同時管理全球複雜的業務運營。
He brings a strong sense of corporate citizenship and his disciplined commitment to excellence makes him a clear professional and cultural fit with our company.
他具有強烈的企業公民意識,他對卓越的嚴謹承諾使他在專業和文化上與我們公司有著明顯的契合。
This is a particularly demanding time for Teva.
對於梯瓦來說,這是一個特別艱難的時期。
And we may continue to face significant headwinds.
我們可能會繼續面臨重大阻力。
But I want you to know that the Board and I remain deeply committed and confident in the strength of the company, our people and in the future of Teva, and even more so that Kåre is the best person to lead Teva now and well into the future.
但我想讓你知道,我和董事會仍然對公司的實力、我們的員工和 Teva 的未來充滿信心和信心,更重要的是,Kåre 是領導 Teva 現在並順利進入未來。
Let me assure you that Kåre will take a fresh perspective as he begins evaluating the opportunities in the near and long-term to improve our performance, build on the company's strengths and position Teva for the future.
讓我向您保證,Kåre 在開始評估近期和長期的機會以提高我們的業績、鞏固公司的優勢並為 Teva 定位未來時,將採取全新的視角。
The reemergence of a successful Teva is important to all of us, for the benefit of patients and shareholders alike.
一個成功的梯瓦(Teva)的重新崛起對我們所有人都很重要,為了患者和股東的利益。
Before I close, I would like to take this opportunity to thank Dr. Yitzhak Peterburg on behalf of myself and Teva's Board of Directors for taking on the interim leadership role at a particularly challenging time, enabling a smooth transition, while remaining focused on our priorities.
在結束之前,我想藉此機會代表我本人和 Teva 的董事會感謝 Yitzhak Peterburg 博士在特別具有挑戰性的時刻擔任臨時領導職務,實現了平穩過渡,同時繼續專注於我們的優先事項.
Throughout our history, we have never shied away from change or challenges.
縱觀我們的歷史,我們從未迴避過變化或挑戰。
That's why Teva and our employees will continue to do whatever is needed to improve our performance.
這就是為什麼 Teva 和我們的員工將繼續採取一切必要措施來提高我們的績效。
I know Kåre shares this commitment and has the background and proven experience to deliver the results that will reestablish Teva as a leader in the industry.
我知道 Kåre 也有同樣的承諾,並且擁有背景和經過驗證的經驗,能夠提供將 Teva 重新確立為行業領導者的結果。
So with that, we will start the Q&A session.
因此,我們將開始問答環節。
Operator, first question, please.
接線員,第一個問題,請。
Operator
Operator
(Operator Instructions) Your first question comes from Liav Abraham from Citi.
(操作員說明)您的第一個問題來自 Citi 的 Liav Abraham。
Liav Abraham - Director
Liav Abraham - Director
A couple of questions.
幾個問題。
Firstly, can you talk a little bit about your -- the pricing trends in the generics base business.
首先,您能否談談您的仿製藥基礎業務的定價趨勢。
I think last quarter, you talked about pricing declines of -- or prices in the high single-digit range.
我認為上個季度,您談到了價格下降或價格在高個位數範圍內。
Is that what you are seeing at the moment as well?
這也是你現在看到的嗎?
And then, can you talk a little bit about your credit rating, just given some of the operating cash flow trends, is investment grade, you didn't allude to that in your remarks.
然後,你能不能談談你的信用評級,只是考慮到一些經營現金流的趨勢,是投資級的,你在你的發言中沒有提到這一點。
So, is investment grade still a priority for the company?
那麼,投資級別仍然是公司的優先事項嗎?
How do you plan on -- if so how do you plan on maintaining that over the next 12 months?
你打算如何——如果是這樣,你打算如何在接下來的 12 個月內保持這種狀態?
And would you consider some kind of equity raise or hybrid structure as a means of paying down debt in order to maintain investment-grade rating?
您是否會考慮將某種股權融資或混合結構作為償還債務以維持投資級評級的一種方式?
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
This is Dipankar.
這是迪潘卡。
I will take the question on price erosion.
我將回答關於價格侵蝕的問題。
As you may recall, last quarter, we explained the methodology that we adopt for our price erosion for the base business, which excludes our new products, which are products that have been launched in the past 12 months; and transition products, which are products, which, for one reason or another, have either enjoyed exclusivity or are enjoying some kind of a market exclusivity, for which, they have had higher prices and volumes and are now going through a transition of lower prices and volumes.
您可能還記得,上個季度,我們解釋了我們為基礎業務價格侵蝕所採用的方法,其中不包括我們的新產品,這些新產品是在過去 12 個月內推出的產品;和過渡產品,這些產品由於某種原因享有排他性或正在享受某種市場排他性,它們的價格和銷量都較高,現在正在經歷價格較低的過渡和卷。
So in the second quarter, we reported a price erosion of a little over 6% for our base business compared to the comparable quarter of the prior year.
因此,在第二季度,與去年同期相比,我們的基礎業務的價格下跌了 6% 以上。
Since then, in our third quarter, we have seen an increase in price erosion.
從那時起,在我們的第三季度,我們看到價格侵蝕有所增加。
And as Mike explained that we have now seen, in the third quarter, the price erosion to be 10%.
正如邁克解釋的那樣,我們現在已經看到,在第三季度,價格下跌了 10%。
This is primarily driven by 2 factors.
這主要是由兩個因素驅動的。
The first is that the increasing FDA approvals that are happening for products, for which, already generics players exist in the market.
首先是 FDA 對產品的批准越來越多,市場上已經存在仿製藥企業。
So the new players try and drive some gains in market share based on volumes -- based on lower prices.
因此,新玩家試圖根據銷量——基於較低的價格——來推動市場份額的增長。
And the second is that the consolidation of the 3 -- of the customers into 3 GPOs, which now account for more than 85% of generics, which is in the U.S. market has also, while their RFPs have created additional pricing pressure.
第二個是將這 3 個客戶合併為 3 個 GPO,這些 GPO 現在占美國市場上仿製藥的 85% 以上,同時他們的 RFP 也產生了額外的定價壓力。
In terms of the rest of the year, we expect that these price erosions will remain at these elevated levels.
就今年剩餘時間而言,我們預計這些價格侵蝕將保持在這些較高的水平。
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
This is Mike.
這是邁克。
I'll take the second part of the question.
我將回答問題的第二部分。
Since the beginning of the year, we've really been focused our efforts on extracting our deal synergies, reducing our cost base and divesting our noncore assets.
自今年年初以來,我們一直致力於挖掘交易協同效應、降低成本基礎和剝離非核心資產。
This is really been with the goal of reducing our leverage.
這確實是為了降低我們的槓桿率。
We continue these efforts, especially, facing all of the headwinds that we have.
我們繼續這些努力,尤其是面對我們所面臨的所有不利因素。
And we also -- we enjoy an active and open dialogue with our credit agencies.
我們也 - 我們與我們的信用機構進行積極和開放的對話。
And we'll continue to work with them as we consider and prepare for all foreseeable scenarios.
在我們考慮和準備所有可預見的情況時,我們將繼續與他們合作。
We have some important decisions to make in order to stay investment-grade.
為了保持投資級別,我們需要做出一些重要的決定。
But we feel we'll be in a better position to really address that in our future calls.
但我們認為我們將處於更好的位置,以便在未來的電話會議中真正解決這個問題。
We'll be working on our 2018 plan together with our new CEO, and evaluating all options to make sure we do what's in the best interest of all stakeholders.
我們將與新任首席執行官一起制定 2018 年計劃,並評估所有選項,以確保我們所做的事情符合所有利益相關者的最大利益。
Currently, we do not have a plan to raise equity.
目前,我們沒有籌資計劃。
But these are some of the things that we will be considering together with new management and the Board as we move into the future.
但這些是我們在邁向未來時將與新管理層和董事會一起考慮的一些事情。
Operator
Operator
And your next question comes from the line from Tim Chiang from BTIG.
您的下一個問題來自 BTIG 的 Tim Chiang。
Timothy Chiang - MD and Specialty Pharmaceutical Research Analyst
Timothy Chiang - MD and Specialty Pharmaceutical Research Analyst
I know, Kåre, you can't really make any comments.
我知道,Kåre,你真的不能發表任何評論。
But maybe the rest of the management team can sort of prioritize what you think 2018 -- the key items, that you will need to address in 2018 to, one, strengthen the balance sheet.
但也許管理團隊的其他成員可以優先考慮你對 2018 年的看法——關鍵事項,你需要在 2018 年解決,以加強資產負債表。
Two, also shore up the generic business.
二是扶持仿製藥業務。
Are there any items that you think -- that you're seeing that are actually somewhat encouraging down the road for you?
有沒有你認為的項目——你看到的實際上對你來說有點鼓舞人心?
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
Yes.
是的。
So, Tim, this is Mike.
所以,蒂姆,這是邁克。
I'll take the first part and then I'll let Dipankar comment a little bit on the generic business.
我將討論第一部分,然後讓 Dipankar 對通用業務進行一些評論。
So we will continue to see strengthening our balance sheet as a priority.
因此,我們將繼續將加強我們的資產負債表視為優先事項。
We are facing headwinds in the generic business.
我們正面臨仿製藥業務的逆風。
And we're facing headwinds now in our COPAXONE business with the launch of a 40-milligram generic.
隨著 40 毫克仿製藥的推出,我們的 COPAXONE 業務現在正面臨逆風。
But we will continue to take all the levers, continue to look at our cost base.
但我們將繼續採取一切手段,繼續審視我們的成本基礎。
We will be doing a review to see if there is additional noncore assets that it would make sense to monetize, and do everything possible to strengthen our balance sheet.
我們將進行審查,看看是否有額外的非核心資產可以用於貨幣化,並儘一切可能加強我們的資產負債表。
But we will be coming back to you with a more drawn-out plan in the coming quarters.
但是,我們將在接下來的幾個季度中為您提供更詳盡的計劃。
After we've had time to really discuss it with new management, take into consideration, all of these evolving events and come back with a very solid plan.
在我們有時間與新管理層真正討論之後,考慮到所有這些不斷變化的事件,並帶著一個非常可靠的計劃回來。
Dipankar, you want to talk a little bit about generics?
Dipankar,你想談談泛型嗎?
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
Yes.
是的。
Thank you, Mike.
謝謝你,邁克。
So regarding the generics business, I'd like -- I like to remind you that the way our generics revenues are structured is approximately 55% of our generics revenue comes from outside the United States and 45% of our revenues come from the U.S. So as far as the business outside of the U.S. is concerned, it has a very different complexion.
所以關於仿製藥業務,我想提醒您,我們的仿製藥收入的結構方式是,我們仿製藥收入的大約 55% 來自美國以外,45% 的收入來自美國。就美國以外的業務而言,它有著截然不同的面貌。
The price erosion is not really a factor in the European business that we see, very low single-digit price erosions, in the Rest of the World those businesses see very little price erosions.
價格侵蝕並不是我們看到的歐洲業務的真正因素,非常低的個位數價格侵蝕,在世界其他地區,這些企業幾乎沒有看到價格侵蝕。
In fact, often, we have opportunities to raise prices.
事實上,我們經常有機會提高價格。
Because they're largely branded generics market.
因為它們主要是品牌仿製藥市場。
These markets are less volatile.
這些市場的波動性較小。
And our prognosis, as far as these markets are concerned, continues to remain fairly optimistic.
就這些市場而言,我們的預測繼續保持相當樂觀。
As far as the U.S. generics business is concerned, there are really 2 areas of focus, both for this year as well as going into next year and all of next year.
就美國仿製藥業務而言,實際上有兩個重點領域,無論是今年還是明年和明年全年。
The first is executing our launches.
首先是執行我們的發布。
Now in terms of the generics business, it is not a recent development.
現在就彷製藥業務而言,這不是最近的發展。
It has been there for a while, which is, that the base business erodes as new and additional competitors come into the market.
它已經存在了一段時間,也就是說,隨著新的和更多的競爭對手進入市場,基礎業務受到侵蝕。
And this, in recent times, has been exacerbated by the increase in the FDA approvals.
最近,FDA 批准的增加加劇了這種情況。
But the real driver of growth and value creation in our generics business is in the execution of our launches.
但我們仿製藥業務增長和價值創造的真正驅動力在於我們的上市執行。
We have over 300 ANDAs filed in terms of our pipeline.
就我們的管道而言,我們已經提交了 300 多個 ANDA。
And we have, in addition, another 300 developments that we are evaluating and remain yet to be filed.
此外,我們還有另外 300 個開發項目正在評估中,但仍有待歸檔。
So we are quite optimistic about our pipeline.
所以我們對我們的管道非常樂觀。
We are targeting approximately $200 billion of brands.
我們的目標是大約 2000 億美元的品牌。
So overall, as far as 2018 is concerned, our focus, in terms of value creation, will continue to remain around new product launches.
因此,總體而言,就 2018 年而言,我們在價值創造方面的重點將繼續圍繞新產品發布。
Regarding the commodity business of the United States generics, I think, that we have about 2/3 of our business, in what we classify as base business, we continue to remain very disciplined and focused on those parts of the base business that creates value.
關於美國仿製藥的商品業務,我認為,我們擁有約 2/3 的業務,在我們歸類為基礎業務的業務中,我們繼續保持非常自律,並專注於基礎業務中創造價值的部分.
And then in the remaining tail of the commodity-type base business that we have, we look at products, where we can change the profitability profile of those products, and if that is not possible, we discontinue the product.
然後在我們擁有的商品類型基礎業務的剩餘尾部中,我們查看產品,我們可以在其中更改這些產品的盈利能力,如果不可能,我們會停止該產品。
So those would be the key elements and ingredients for 2018 and beyond for improving the profile and value of our generics business.
因此,這些將是 2018 年及以後改善我們仿製藥業務的形象和價值的關鍵要素和要素。
Timothy Chiang - MD and Specialty Pharmaceutical Research Analyst
Timothy Chiang - MD and Specialty Pharmaceutical Research Analyst
I just had a one quick follow up, if I may.
如果可以的話,我只是進行了一次快速跟進。
Are you guys still reiterating your debt paydown target of $5 billion?
你們還在重申50億美元的債務償還目標嗎?
I didn't see that in the press release?
我在新聞發布會上沒看到?
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
No, Tim.
不,蒂姆。
Due to the lower cash flow in Q4, particularly, the Actavis working capital disputes that's moved out.
由於第四季度的現金流量較低,特別是阿特維斯的營運資金糾紛已被移出。
And due to the potential timing of the receipt of the divestments, we are looking more at a range of $3.5 billion to $4 billion.
由於收到撤資的潛在時間,我們更多地關注 35 億至 40 億美元的範圍。
This is partially impacted by currency rates.
這部分受到匯率的影響。
We've seen the euro strengthen over the year, and we have over $8 billion in bonds denominated in euros.
我們已經看到歐元在過去一年中走強,我們有超過 80 億美元的以歐元計價的債券。
So the overall impact of the paydown is being partially offset by currency impacts.
因此,還款的整體影響被貨幣影響部分抵消。
But we're not going to quite get to $5 billion this year as we'd originally planned, mainly due to some of the slippage of the cash flow from Q4 into Q1.
但今年我們不會像我們最初計劃的那樣達到 50 億美元,主要是由於現金流從第四季度到第一季度的一些下滑。
But we are aiming to pay down the debt as quickly as possible.
但我們的目標是盡快償還債務。
We are using the proceeds yesterday that came in from the PARAGARD sale, have already been used to pay down term loans.
我們正在使用昨天從 PARAGARD 出售中獲得的收益,已經用於償還定期貸款。
And we plan to do the same with other divestment cash as well as the cash flow generated in Q4.
我們計劃對其他撤資現金以及第四季度產生的現金流做同樣的事情。
Operator
Operator
Your next question is from the line of David Maris from Wells Fargo.
您的下一個問題來自富國銀行的 David Maris。
David William Maris - Senior Analyst
David William Maris - Senior Analyst
So, Dipankar, you said that you'd have $500 million to $750 million of generics in 2017, that were kind of pushed out from '16 and then that came down to $500 million, now it's $400 million and the same thing happened with the price erosion expectations.
所以,Dipankar,你說你在 2017 年會有 5 億到 7.5 億美元的仿製藥,從 16 年開始推出,然後下降到 5 億美元,現在是 4 億美元,同樣的事情發生在價格侵蝕預期。
So I have a couple of questions.
所以我有幾個問題。
First, is this just the -- how less predictable the business has become or is there something with the -- with either the finance or the forecasting ability of Teva, given all the turnover to predict the business?
首先,考慮到所有營業額都可以預測業務,這是否只是 - 業務變得越來越難以預測,或者與 Teva 的財務或預測能力有什麼關係?
And then separately, on -- if we assume that the debt is downgraded, as we think is likely, can you walk us through what the debt maturities are in the next couple of years?
然後單獨,如果我們假設債務被降級,正如我們認為的那樣,你能告訴我們未來幾年的債務到期情況嗎?
And what you think the added cost would be under, say, if you wanted to refinance that -- the near-term debt, maybe in the next few years versus the current blended rate, what that difference would be?
你認為增加的成本會低於,比如說,如果你想再融資——短期債務,可能在未來幾年內,與目前的混合利率相比,會有什麼區別?
And also, is there anything, I think, we've spoken about this before.
而且,有什麼,我想,我們以前談過這個。
But the -- in a debt downgrade, is there any debt that automatically becomes at a higher rate?
但是——在債務降級中,是否有任何債務自動變得更高?
And can you just walk us through or reconfirm the debts about $6 billion and 12.5 basis points?
你能告訴我們或重新確認大約 60 億美元和 12.5 個基點的債務嗎?
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
David, this is Dipankar.
大衛,這是迪潘卡。
I will take the first part of your question regarding the new product forecast.
我將回答您關於新產品預測的問題的第一部分。
So first is, we always spoke about $500 million right from February onwards, as what we felt good about and anything beyond that had significant uncertainties associated with that.
首先是,從 2 月開始,我們總是談論 5 億美元,因為我們感覺良好,除此之外的任何事情都有與之相關的重大不確定性。
So for the $500 million, also, we spoke that about launches, which were date certain and there were certain launches where of the 4 stage gates that we had to go through, which is clearing the way through legal, getting a regulatory approval, operational readiness and then our ability to launch the product.
因此,對於 5 億美元,我們還談到了發布,這是確定日期的,並且在某些發布中,我們必須通過 4 個階段的大門,這為通過法律、獲得監管批准、運營掃清道路準備就緒,然後是我們推出產品的能力。
We, in most of those instances, we had at least 3 of those bases covered.
在大多數情況下,我們至少覆蓋了其中的 3 個基地。
Now, why did the number go down from $500 million to $400 million to what we are forecasting at this point in time?
現在,為什麼這個數字會從 5 億美元下降到 4 億美元,達到我們目前預測的水平?
The most significant contributors to that were really a handful of products.
最重要的貢獻者實際上是少數產品。
And let me give you some examples.
讓我給你一些例子。
So we had anticipated getting an approval for the generics of Lialda in the second half of the year.
因此,我們預計今年下半年將獲得 Lialda 仿製藥的批准。
In working together with FDA, our understanding is, most, if not almost all of the approval processes and the reviews are close to completion, nevertheless, we are still awaiting approval.
在與 FDA 的合作中,我們的理解是,即使不是幾乎所有的批准程序和審查都已接近完成,但我們仍在等待批准。
The second example I can give you is the generics of NuvaRing, which we had planned.
我可以給你的第二個例子是我們計劃好的 NuvaRing 的泛型。
And we had -- we thought it was a relatively strong position that we had in the appeal that was carried out.
我們有 - 我們認為這是我們在執行的上訴中擁有的相對強大的立場。
But the court decision went against us.
但是法院的判決對我們不利。
So those are the kind of things that contributed significantly to the change in the number.
因此,這些都是對數字變化做出重大貢獻的事情。
Now I don't think the nature of the business has changed.
現在我認為業務的性質沒有改變。
Our new product forecast has built-in date-certain launches.
我們的新產品預測內置了特定日期的發布。
And where we feel relatively good about because most of the clearing of the way has been done.
我們感覺相對較好的地方,因為大部分的道路清理工作已經完成。
But this has been the nature of the generics business for a very, very long time.
但這一直是仿製藥業務的本質,已經有很長一段時間了。
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
Hi, David.
嗨,大衛。
This is Mike.
這是邁克。
I'll try to address the second 2 questions, mainly, around the debt.
我將嘗試解決第二個問題,主要是圍繞債務。
Of course, we're going to be working with our rating agencies and other partners on this.
當然,我們將在這方面與我們的評級機構和其他合作夥伴合作。
But in the case that there was a potential downgrade, it's really just the $6 billion of term loans that would be impacted immediately.
但在可能降級的情況下,實際上只有 60 億美元的定期貸款會立即受到影響。
We have over 80% of our debt in fixed rates at this point.
目前,我們有超過 80% 的債務是固定利率的。
The term loans would be subject to a 25-basis point-increase upon a notch downgrade in their interest rates.
如果利率下調一個檔次,定期貸款將增加 25 個基點。
In terms of maturities in the coming years, in 2018, we have $5.5 billion.
就未來幾年的期限而言,2018 年,我們有 55 億美元。
And in '19, '20, '21, roughly $4 billion in maturities each year.
在 19 年、20 年、21 年,每年大約有 40 億美元到期。
At some point, we may look to refinance that.
在某個時候,我們可能會尋求再融資。
And if we are looking at refinancing and we would get a theoretical downgrade, you're probably looking at 100 to 150 basis points increase on the interest rate of those maturities, depending, of course, on the tenors -- the time frame we put them out.
如果我們正在考慮再融資並且我們會得到理論上的降級,那麼您可能會看到這些到期日的利率增加 100 到 150 個基點,當然,這取決於期限——我們設定的時間框架他們出去。
So there's lots of variabilities there.
所以那裡有很多變數。
But that, hopefully, will give you basically a picture of the overall debt.
但是,希望這能讓您基本了解總體債務。
Of course, in the term loans of $6 billion, we do plan to pay those down.
當然,在 60 億美元的定期貸款中,我們確實計劃償還這些貸款。
We've already put $1.1 billion against it from the asset sales that we did yesterday.
我們已經從昨天進行的資產出售中投入了 11 億美元。
We will plan to do that with future.
我們將計劃在未來這樣做。
So take that into consideration, when you're calculating the amount of debt that could be subject to higher interest rates.
因此,在計算可能受到更高利率影響的債務金額時,請考慮到這一點。
Operator
Operator
Your next question is from the line of Marc Goodman from UBS.
您的下一個問題來自瑞銀的 Marc Goodman。
Marc Harold Goodman - MD and United States Healthcare Analyst
Marc Harold Goodman - MD and United States Healthcare Analyst
Two questions.
兩個問題。
First, COPAXONE.
首先,COPAXONE。
Can you give us a flavor of what's going on right now in the channel?
您能給我們介紹一下頻道中正在發生的事情嗎?
How much pricing did Mylan take versus how much pricing you've taken, you decided not to launch or authorize generic suit, maybe whatever details you are willing to give us from that situation?
Mylan 採取了多少定價與您採取了多少定價,您決定不推出或授權通用套裝,也許您願意從這種情況向我們提供任何細節?
And why has guidance continuously come down on COPAXONE, when I would have thought that it's pretty straightforward what was going to happen.
以及為什麼在 COPAXONE 上不斷出現指導意見,而我本以為會發生什麼很簡單。
That's why I'm asking the question.
這就是我問這個問題的原因。
And then second question, Dipankar, you've talked about 2018 U.S. generics being below '17; 2019, being below 2018.
然後是第二個問題,Dipankar,您談到 2018 年美國仿製藥低於 17 年; 2019 年低於 2018 年。
I was wondering if that's still how you see it, the operating margins you've talked about once we get through all the synergies moving into the mid-20s, is that still realistic and how soon do we get there?
我想知道這是否仍然是您的看法,一旦我們進入 20 年代中期,您所談到的營業利潤率是否仍然現實,我們多久能達到目標?
Robert Koremans - President & CEO of Global Specialty Medicines Group
Robert Koremans - President & CEO of Global Specialty Medicines Group
Hi, Mark, this is Rob.
嗨,馬克,我是羅布。
I'll take your COPAXONE question.
我會回答你的 COPAXONE 問題。
Of course, we've been waiting and ready for a generic to launch.
當然,我們一直在等待並準備推出通用產品。
But when Mylan came, and we've really had a very good position with most of the payers and PBMs securing just over 60% of our units through contracts.
但是,當邁蘭到來時,我們確實處於非常有利的地位,大多數付款人和 PBM 通過合同確保了我們 60% 以上的單位。
And we've really been executing on that extremely fast, what we, however, did see is for the -- Mylan came in with a lower price and net price or higher discount than any analogue or any previous experience would suggest.
而且我們確實一直在以極快的速度執行,然而,我們確實看到的是 - Mylan 以比任何類似物或任何以前的經驗所暗示的更低的價格和淨價或更高的折扣進入。
So this was higher than expected.
所以這比預期的要高。
And that's what you see reflected in the figures that Mike shared with you.
這就是你在邁克與你分享的數據中所看到的。
So in terms of volumes, we are doing exactly as we expected, in fact, slightly better, but they are at a lower net price.
因此,就數量而言,我們的表現完全符合我們的預期,實際上略好一些,但它們的淨價較低。
Marc Harold Goodman - MD and United States Healthcare Analyst
Marc Harold Goodman - MD and United States Healthcare Analyst
Can you share with us what you're expecting and what they came in at?
你能和我們分享你的期望和他們的到來嗎?
Robert Koremans - President & CEO of Global Specialty Medicines Group
Robert Koremans - President & CEO of Global Specialty Medicines Group
No, I don't think that would be wise.
不,我認為這不明智。
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
Marc, let me take the second part of your question.
馬克,讓我來回答你問題的第二部分。
We are right now focused on executing the rest of 2017.
我們現在專注於執行 2017 年剩餘的時間。
We have our own budget process to go through.
我們有自己的預算流程要經過。
And it's a little premature to talk about 2018 at this point in time.
現在談論 2018 年還為時過早。
Operator
Operator
Your next question is from the line of Chris Schott from JP Morgan.
您的下一個問題來自摩根大通的 Chris Schott。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
Just coming back on generic gross margins.
剛剛回到通用毛利率。
I know you are not going to give us formal commentary about '18.
我知道你不會給我們關於 18 年的正式評論。
But it seems like you had very severe erosion these last few quarters, so can you just give us a little bit of color on -- should we expect these margins to remain in these very low levels as we look out to 4Q?
但看起來你在過去幾個季度受到了非常嚴重的侵蝕,所以你能給我們一點色彩嗎——我們是否應該期待這些利潤率在我們展望第四季度時保持在這些非常低的水平?
And beyond just new product launches, is there anything you can think about that should lead to improving gross margin performance on the generic business?
除了新產品發布之外,您還有什麼可以考慮的可以提高仿製藥業務的毛利率表現的嗎?
Just trying to get my hands around, directionally, where that margin is going.
只是試圖讓我的手有方向地了解該邊距的去向。
The second question is also on COPAXONE.
第二個問題也是關於 COPAXONE。
I know you talked about the $0.30 of impact.
我知道你談到了 0.30 美元的影響。
Can you just give us, again, just some sense of the percent erosion you're factoring in there on the COPAXONE revenue and just again, so we're thinking about run rates into '18, does that reflect a pretty high level of erosion at this point or should we think about further step downs in the COPAXONE franchise, again, from that 4Q run rate as we think out to next year?
您能否再次給我們一些關於您在 COPAXONE 收入中考慮的百分比侵蝕的感覺,所以我們正在考慮到 18 年的運行率,這是否反映了相當高的侵蝕水平在這一點上,還是我們應該考慮進一步降低 COPAXONE 特許經營權,再次,從我們認為到明年的第四季度運行率?
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
I'll take a little bit of the gross margin on generics and then we can maybe give you a little bit more flavor from Dipankar and Rob.
我會拿一點仿製藥的毛利率,然後我們也許可以給你一點 Dipankar 和 Rob 的味道。
So the overall gross margin, the net margin on generics has been declining.
所以整體毛利率,仿製藥的淨利潤一直在下降。
We do -- it's driven by a couple of things.
我們這樣做 - 它是由幾件事驅動的。
One is the level of price erosion we've seen in the U.S. generic business.
一是我們在美國仿製藥業務中看到的價格侵蝕程度。
We've seen lower contribution from our business in Venezuela over the quarters and compared to last year.
與去年相比,本季度我們在委內瑞拉的業務貢獻較低。
We've also seen some unfavorable FX and other variance in our costs of goods sold.
我們還看到我們的銷售成本出現了一些不利的外彙和其他差異。
So all of those things have been pressuring margins, especially, in our U.S. generic business.
因此,所有這些事情都在給利潤率帶來壓力,尤其是在我們的美國仿製藥業務中。
We would expect Q4 to tick up a little bit because of the new launches.
由於新的發布,我們預計第四季度會有所上升。
We've had relatively lower levels of new launches in Q3.
我們在第三季度推出的新產品數量相對較低。
And that should pick up with some date-certain launches in Q4.
這應該會隨著第四季度的某些日期確定的發布而有所回升。
When it comes to COPAXONE, you will see a normal erosion curve on that.
談到 COPAXONE,您會看到一條正常的侵蝕曲線。
I don't think we want to get into too much detail for confidentiality reasons on pricing and impact.
出於保密原因,我認為我們不想在定價和影響方面透露太多細節。
But a normal erosion where it accelerates slightly and then it flattens out over the course of time would make sense to us.
但是,正常的侵蝕會稍微加速,然後隨著時間的推移變平,這對我們來說是有意義的。
So Rob, maybe you can add a little to that.
所以 Rob,也許你可以補充一點。
Robert Koremans - President & CEO of Global Specialty Medicines Group
Robert Koremans - President & CEO of Global Specialty Medicines Group
Happy to do.
樂於做。
So I think, what you're seeing now is the erosion as the result of Mylan launching into the 40-milligram space and also in 20-milligram, right.
所以我認為,你現在看到的是邁蘭進入 40 毫克空間和 20 毫克空間的結果,對吧。
So we also see an impact from 20-milligram.
所以我們也看到了 20 毫克的影響。
And -- if there were to be additional generics on 40-milligram or if one of the players changes their game dramatically, obviously, this would impact also what we would have to do.
而且——如果在 40 毫克的藥物上有額外的仿製藥,或者如果其中一名球員顯著改變了他們的比賽,顯然,這也會影響我們必須做的事情。
Like I said before, we have secured in contracts over 60% of the units.
就像我之前說的,我們已經簽訂了超過 60% 的單位的合同。
And that's at the moment, what you see in '17's forecast.
這就是目前,你在 17 年的預測中看到的。
We're working on '18, a lot of the cost of COPAXONE we have been refocusing on launching AUSTEDO there is a fairly large overlap of about 2/3 of the customer base between Huntington's and tardive dyskinesia.
我們正在研究 18 年,COPAXONE 的很多成本我們一直在重新關注推出 AUSTEDO,亨廷頓氏症和遲發性運動障礙之間有大約 2/3 的客戶群有相當大的重疊。
And also next year, we are very much planning to launch our fremanezumab, which is a very exciting opportunity.
同樣在明年,我們非常計劃推出我們的 fremanezumab,這是一個非常令人興奮的機會。
The 2 opportunities there on AUSTEDO and fremanezumab, obviously, require all our investments and focus and energy and brings down the investment we do in COPAXONE, which is a natural effect anyway there.
顯然,AUSTEDO 和 fremanezumab 的兩個機會需要我們所有的投資、專注和精力,並降低了我們對 COPAXONE 的投資,這無論如何都是自然的影響。
So that improves the margin in that sense on COPAXONE and helps us to do something very important for 2018, continue the launch of AUSTEDO and prepare for the launch and execute the launch of fremanezumab in migraine.
因此,這提高了 COPAXONE 的利潤率,並幫助我們為 2018 年做一些非常重要的事情,繼續推出 AUSTEDO 並為推出和執行用於偏頭痛的 fremanezumab 的推出做準備。
Kevin C. Mannix - Head of Global IR
Kevin C. Mannix - Head of Global IR
Thank you.
謝謝你。
Next question.
下一個問題。
Operator
Operator
Next question is from Umer Raffat from Evercore.
下一個問題來自 Evercore 的 Umer Raffat。
Umer Raffat - Senior MD and Fundamental Research Analyst
Umer Raffat - Senior MD and Fundamental Research Analyst
I wanted to focus on debt and then on the branded side, if I may.
如果可以的話,我想專注於債務,然後是品牌方面。
On the debt side, so if I'm doing my math correctly, your 4Q guidance implies an EBITDA of $1.3 billion in the fourth quarter or effectively about a $5 billion run rate going into 2018 and that includes COPAXONE.
在債務方面,所以如果我的數學計算正確,你的第四季度指導意味著第四季度的 EBITDA 為 13 億美元,或者實際上到 2018 年的運行率約為 50 億美元,其中包括 COPAXONE。
Your year-end '17, net debt is $30 billion.
你 17 年年底的淨債務是 300 億美元。
So that's about 6x and again, the EBITDA number includes COPAXONE.
所以這大約是 6 倍,EBITDA 數字包括 COPAXONE。
So my question is this, what's the track on the debt side.
所以我的問題是,債務方面的軌跡是什麼。
Just to understand at a high level, what would be the track, the $5 billion EBITDA versus $30 billion debt going into 2018, first?
只是為了從高層次上理解,首先是什麼軌道,50 億美元的 EBITDA 與 300 億美元的債務進入 2018 年?
And on the branded side, I was curious, what's the breakeven on CGRP sales from an EBITDA perspective.
在品牌方面,我很好奇,從 EBITDA 的角度來看,CGRP 銷售的盈虧平衡點是多少。
What's the sale threshold in which the CGRP launch starts to become a breakeven on EBITDA.
CGRP 的推出開始成為 EBITDA 盈虧平衡點的銷售門檻是多少?
Because I understand that might involve investment?
因為我知道這可能涉及投資?
And finally, I noticed no mention on AUSTEDO on the call or in the press release, certainly, not in the press release despite a huge beep that Neurocrine put up in their press release last night.
最後,我注意到在電話會議或新聞稿中沒有提到 AUSTEDO,當然,在新聞稿中也沒有提及,儘管 Neurocrine 在昨晚的新聞稿中發出了巨大的嗶嗶聲。
So I was trying to understand the dynamic there?
所以我試圖了解那裡的動態?
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
So I'll take the first question.
所以我會回答第一個問題。
Of course, we are still in the process of developing 2018.
當然,2018年我們還在開發中。
So I can't really give you a hard figure on EBITDA.
所以我真的不能給你一個關於 EBITDA 的硬數字。
But we will be closely monitoring our debt situation.
但我們將密切關注我們的債務狀況。
We will be paying down as much as we can with these asset divestments and the other things, including the working capital dispute that we expect to resolve in Q1.
我們將盡可能多地支付這些資產剝離和其他事情,包括我們希望在第一季度解決的營運資金糾紛。
We'll be coming back to you -- in our year-end, giving you a layout of exactly what's going to happen with 2018.
我們將在年終回复您,為您提供 2018 年將要發生的確切佈局。
But, of course, we'll be making all of our plans to address it.
但是,當然,我們將製定所有計劃來解決它。
We will be working together with our lending partners and the rating agencies, as we layout that plan.
在製定該計劃時,我們將與我們的貸款合作夥伴和評級機構合作。
But we do see, we're going to have to urgently address our 2018 situation.
但我們確實看到,我們將不得不緊急處理 2018 年的情況。
But until we've worked out our plan, including additional cost savings, additional asset divestments, it's too early to comment too fully on that.
但是,在我們制定出我們的計劃之前,包括額外的成本節約、額外的資產剝離,現在對此發表評論還為時過早。
And in terms of the CGRP, in terms of margins, you've got to expect, since we are launching late 2018 that '18 and '19 are not going to be accretive to income.
就 CGRP 而言,就利潤率而言,你必須期待,因為我們將在 2018 年底推出 '18 和 '19 不會增加收入。
As we get into the '20 and beyond, we will start to see a real profitability coming from that product.
隨著我們進入 20 世紀及以後,我們將開始看到該產品帶來真正的盈利能力。
AUSTEDO, I think, we did mention somewhere in our press release.
AUSTEDO,我想,我們確實在我們的新聞稿中提到過。
We had 6 million sales booked in the quarter.
我們在本季度預訂了 600 萬筆銷售額。
I'll let Rob comment a little bit on how we're approaching that product.
我會讓 Rob 評論一下我們如何接近該產品。
Because we are having some period where we are giving product to the patients as they titrate up.
因為我們有一段時間會在患者滴定時向他們提供產品。
But, Rob, maybe you want to comment on that?
但是,Rob,也許你想對此發表評論?
Robert Koremans - President & CEO of Global Specialty Medicines Group
Robert Koremans - President & CEO of Global Specialty Medicines Group
Yes.
是的。
Pleasure, Mike.
很高興,邁克。
With AUSTEDO we're doing really well.
使用 AUSTEDO,我們做得非常好。
We are tracking in line with our plan in terms of patients.
我們正在按照我們的計劃跟踪患者。
I need to remind you probably that we initiate patients on a titration, which is not charged, so there is no sales, no revenues generated there.
我可能需要提醒您,我們開始對患者進行滴定,這是不收費的,因此沒有銷售,也沒有產生收入。
But in terms of patients captured, both on Huntington's and on tardive dyskinesia and that's where Neurocrine is our competitor.
但就捕獲的患者而言,無論是亨廷頓舞蹈症還是遲發性運動障礙,這就是 Neurocrine 是我們的競爭對手。
I am very encouraged also when I see the Neurocrine figures, it shows clearly that there is a market.
當我看到 Neurocrine 的數據時,我也很受鼓舞,它清楚地表明有市場。
And I think there was some skepticism among some of the analysts before that would payers be blocking this.
而且我認為,在此之前,一些分析師對付款人是否會阻止這一點持懷疑態度。
We see none of that.
我們沒有看到這些。
So there is a real good acceptance.
所以有一個很好的接受度。
Clearly, this is a new treatment paradigm for psychiatry, from psychiatrists towards something -- there is a lot of education to be done.
顯然,這是一種新的精神病學治療範式,從精神病學家到某些東西——還有很多教育要做。
But we are, in terms of patient recruiting, tracking, in line or even slightly ahead of what Neurocrine is doing.
但是,在患者招募、跟踪方面,我們與 Neurocrine 正在做的事情保持一致甚至略領先。
They report different sales, right.
他們報告不同的銷售額,對。
The sales that they have is everything that goes to wholesalers and retail and the specialty pharmacies immediately reported as sales.
他們擁有的銷售額是批發商和零售店以及專業藥房立即報告為銷售額的一切。
And we only do that when data confirm the pull-through to patients.
我們只有在數據確認對患者有幫助時才會這樣做。
So you look at different numbers from us.
所以你從我們那裡看到不同的數字。
But we are really happy with progress, both on Huntington's and on tardive dyskinesia.
但我們對亨廷頓氏症和遲發性運動障礙的進展感到非常滿意。
And going forward, also, this is an important opportunity.
展望未來,這也是一個重要的機會。
A lot of education to be done.
很多教育要做。
We always cautioned that this would not be a fast ramp up sales, but an important opportunity going forward.
我們一直警告說,這不會是一個快速的銷售增長,而是一個重要的未來機會。
Michael R. Hayden - President of Global R&D and Chief Scientific Officer
Michael R. Hayden - President of Global R&D and Chief Scientific Officer
And let me just add on.
讓我補充一下。
And this is Michael.
這是邁克爾。
AUSTEDO, of course, we are also beginning our studies on the third indication that we're developing AUSTEDO for Tourette syndrome.
AUSTEDO,當然,我們也開始研究第三個跡象,即我們正在開髮用於 Tourette 綜合徵的 AUSTEDO。
This is going to be a Phase III study, aligned with the FDA.
這將是一項與 FDA 保持一致的 III 期研究。
And this will be starting in the next few months with our development partner Nuvelution.
這將在未來幾個月與我們的開發合作夥伴 Nuvelution 一起開始。
Kevin C. Mannix - Head of Global IR
Kevin C. Mannix - Head of Global IR
Kalem, next question, please.
卡萊姆,請下一個問題。
Operator
Operator
That comes from the line of Jami Rubin from Goldman Sachs.
這來自高盛的 Jami Rubin。
Jamilu E. Rubin - Equity Analyst
Jamilu E. Rubin - Equity Analyst
Kåre, just want to offer my congratulations, looking forward to meeting you, and you certainly do have your work cut out for you.
Kåre,只是想向您表示祝賀,期待與您會面,而且您的工作肯定是為您完成的。
Sol, maybe if I could ask you a question since we are not going to hear yet from the new CEO.
索爾,也許我可以問你一個問題,因為我們還沒有收到新 CEO 的消息。
Is there anything that the Board would stand in the way of what Kåre might want to do in repositioning the company going forward, anything off the table.
董事會是否會阻礙 Kåre 在重新定位公司前進時可能想做的事情?
And secondly, just we've had this study cadence of earnings downgrades and I can't even keep track of the number of quarters.
其次,只是我們已經有了這種盈利下調的研究節奏,我什至無法跟踪季度數。
But it seems that some of the problem relates to the company's internal information systems, planning, et cetera, et cetera.
但似乎有些問題與公司的內部信息系統、規劃等有關。
How fixable do you think that is?
你認為這有多可修復?
Because it's just, it's kind of uncanny that just the number of downgrades, but it seems that some of this might just be -- may also be due to the fact that the internal systems are not where they should be, not where the rest of the industry is.
因為只是降級的數量有點不可思議,但似乎其中一些可能只是——也可能是由於內部系統不在它們應該在的地方,而不是在其他地方行業是。
So I'm just wondering how fixable that might be?
所以我只是想知道這有多可修復?
And just last question, curious to know if you filed an ANDA for levothyroxine?
最後一個問題,想知道您是否為左甲狀腺素提交了 ANDA?
Sol J. Barer - Chairman of the Board
Sol J. Barer - Chairman of the Board
I'll take the first question and then I will turn it over to Mike regarding the internal systems and things of that sort.
我將回答第一個問題,然後將其轉交給 Mike,了解內部系統和類似的事情。
As you know, we performed a long, extremely thorough search around the world for the best person to lead Teva.
如您所知,我們在全球範圍內進行了漫長而徹底的搜索,以尋找領導 Teva 的最佳人選。
And I promised that in a couple of calls, and we found that individual.
我在幾個電話中承諾了這一點,我們找到了那個人。
I and the Board have great confidence in Kåre.
我和董事會對 Kåre 充滿信心。
And we are looking to Kåre to lead this company, obviously, in partnership with the Board.
顯然,我們希望 Kåre 與董事會合作領導這家公司。
But he will develop the strategy, the plans, et cetera.
但他將製定戰略、計劃等。
So you can't give any guarantees whatsoever.
所以你不能給任何保證。
But Kåre will be the leader of this company.
但 Kåre 將成為這家公司的領導者。
And I'm very confident in terms of what he is going to do.
而且我對他將要做的事情非常有信心。
And I'm not worried about any sort of dynamics, political or whatever that will stand in the way.
而且我不擔心任何形式的動態,政治或任何會阻礙的東西。
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
Jami, this is Mike.
傑米,這是邁克。
Clearly, we're working on all our internal systems and processes.
顯然,我們正在處理我們所有的內部系統和流程。
We did a large merger recently.
我們最近進行了一次大型合併。
So we're coming together on that.
所以我們在這方面走到了一起。
But I would put the difficulty in guidance more down to the lack of visibility in this incredibly changing environment.
但我將指導的困難更多地歸結為在這個令人難以置信的變化環境中缺乏可見性。
We are facing, now, 2 headwinds, continued pressure in the U.S. generics and in our COPAXONE.
現在,我們面臨兩個逆風,即美國仿製藥和我們的 COPAXONE 的持續壓力。
We've made estimates on that.
我們已經對此進行了估計。
But clearly, we need to take a look at our internal valuations and our approach to how we're looking at the future and try to get sharper.
但顯然,我們需要看看我們的內部估值以及我們如何看待未來的方法,並努力變得更加敏銳。
That's very clear.
這很清楚。
We will be focusing on that.
我們將專注於此。
We will be focusing on continuing to improve our systems and processes.
我們將專注於繼續改進我們的系統和流程。
It is a key priority, not only of mine, but I'm sure it will be of the new management.
這是一個關鍵的優先事項,不僅是我的,而且我相信它將是新管理層的。
Operator
Operator
Your next question is from Greg Gilbert from Deutsche Bank.
您的下一個問題來自德意志銀行的 Greg Gilbert。
Gregory B. Gilbert - MD and Senior Analyst
Gregory B. Gilbert - MD and Senior Analyst
Sticking with the U.S. generics, sort of lack of predictability of your business.
堅持使用美國仿製藥,您的業務缺乏可預測性。
You've talked about the amount of new products to come this year.
你談到了今年要推出的新產品的數量。
I assume those are all date-certains and you're not betting anything anymore in (inaudible) . So hopefully, can you confirm that.
我認為這些都是日期確定的,並且您不再在 (聽不清) 中投注任何東西。所以希望你能證實這一點。
You've spoken to the amount of new products, you spoken of 10% erosion, but you have not commented on what your assumptions are for volume loss across the business or on sort of volume or price for those transition or unique products.
你談到了新產品的數量,你談到了 10% 的侵蝕,但你沒有評論你對整個業務的銷量損失的假設是什麼,或者對這些過渡或獨特產品的數量或價格的排序。
So hopefully, you can give us a fuller picture of all those elements because it appears you've missed on several of those elements, not just the $400 million from $500 million, and not just the 10% versus the 6%.
所以希望你能給我們提供所有這些元素的更全面的圖片,因為你似乎錯過了其中的幾個元素,不僅僅是 4 億美元和 5 億美元,而且不僅僅是 10% 和 6%。
So can you walk us through all elements of that process?
那麼,您能帶領我們了解該過程的所有要素嗎?
On COPAXONE, can you give us your thoughts on generic COPAXONE exposure outside the U.S. in as much detail as you can?
關於 COPAXONE,您能否盡可能詳細地告訴我們您對美國以外通用 COPAXONE 暴露的看法?
And lastly, how much did you spend in the quarter on COPAXONE sales and marketing and infrastructure?
最後,您在本季度在 COPAXONE 銷售、營銷和基礎設施上花費了多少?
And how much of that is needed to support the other products?
支持其他產品需要多少?
It sounds from Rob's comments that you need of all it, but hoping you can provide some more granularity on specifically what was spent and whether you need all of that going forward for the other products?
從 Rob 的評論中聽起來您需要所有這些,但希望您可以提供更多的詳細信息,具體說明花費了什麼以及您是否需要為其他產品提供所有這些?
Robert Koremans - President & CEO of Global Specialty Medicines Group
Robert Koremans - President & CEO of Global Specialty Medicines Group
Should I take COPAXONE first, it's probably good.
我應該先服用COPAXONE,它可能很好。
As you know, we sell COPAXONE also outside of the U.S. on the $1 billion that we had in the quarter.
如您所知,我們在本季度擁有的 10 億美元也在美國以外的地區出售 COPAXONE。
This is just shy of $200 million.
這僅略低於 2 億美元。
The European market situation is going to be very different.
歐洲市場情況將大不相同。
There is one 20-milligram COPAXONE generic already on the market in Europe.
歐洲市場上已經有一種 20 毫克的 COPAXONE 仿製藥。
The authorities have asked for data to show efficacy and safety.
當局已要求提供數據以顯示有效性和安全性。
And these generics are not substitution generics, the so-called follow-on generics, and they will have to compete in the doctor's office.
而且這些仿製藥不是替代仿製藥,即所謂的仿製藥,它們將不得不在醫生辦公室競爭。
Synthon, who developed this product and it's marketed by Mylan in most markets that was a fairly expensive development for them as well, doing full clinical development or almost full clinical development.
Synthon 開發了該產品,並由 Mylan 在大多數市場上銷售,這對他們來說也是一個相當昂貴的開發,進行完整的臨床開發或幾乎完整的臨床開發。
So what we've seen so far is very, very, very modest erosion, less than 1%.
所以到目前為止,我們所看到的侵蝕非常、非常、非常溫和,不到 1%。
What could happen going forward in certain countries, some Nordic countries, for instance, you can be pulled into tendering and that would definitely impact some of our pricing.
在某些國家,例如一些北歐國家,未來可能會發生什麼,你可能會參與招標,這肯定會影響我們的一些定價。
But I don't think that our volumes are going to be impacted all that dramatically.
但我不認為我們的銷量會受到如此巨大的影響。
The second dynamic that happens in Europe standard, where the product that is over 15 years on the market is, authorities, and again, country-by-country review pricing, and there are sometimes automatic price changes, right.
在歐洲標準中發生的第二個動態是,在市場上超過 15 年的產品是當局,再次是逐個國家審查定價,有時價格會自動變化,對吧。
The -- and the third thing is the legal component.
- 第三件事是法律部分。
We still have a patent covering all of the molecule and production in Europe going forward for a long time.
在很長一段時間內,我們仍然擁有涵蓋歐洲所有分子和生產的專利。
And we will continue to fight country-by-country.
我們將繼續逐個國家作戰。
And again, Europe, this is very much a country-by-country fight.
再說一次,歐洲,這在很大程度上是一場國與國之間的鬥爭。
So the durability, if you like, of COPAXONE in Europe is much, much better because of all those 3 reasons that I just mentioned.
因此,由於我剛才提到的所有這 3 個原因,COPAXONE 在歐洲的耐用性要好得多。
And in '17, we definitely do not foresee a big impact of any generic.
在 17 年,我們絕對不會預見到任何仿製藥的重大影響。
In '18, there will be some pricing impact, not related to the generics, but more related to the measures that authorities take in Europe as a standard thing.
在 18 年,會有一些定價影響,與仿製藥無關,但更多與當局在歐洲採取的標準措施有關。
In terms of your expenses, obviously, we'll bring down some of the expenses as they are sales force-related.
顯然,就您的費用而言,我們會降低一些費用,因為它們與銷售人員有關。
A lot of that will go to AUSTEDO and the preparation of the launch for fremanezumab.
其中很大一部分將用於 AUSTEDO 和 fremanezumab 發布的準備工作。
Some of the direct expenditure for COPAXONE, we are reviewing and we've already brought down some.
COPAXONE 的一些直接支出,我們正在審查,我們已經減少了一些。
And going forward, we'll continue to really look at what is the right investment level.
展望未來,我們將繼續真正研究什麼是正確的投資水平。
At the moment, we really look at very good return, still for the COPAXONE, but will make those decisions very prudently and not with a long-term defense of COPAXONE, but really much more on maximizing profitability and keeping COPAXONE as a brand available to patients in the U.S.
目前,我們確實看到了非常好的回報,仍然是 COPAXONE,但將非常謹慎地做出這些決定,而不是長期捍衛 COPAXONE,而是更多地關注最大化盈利能力和保持 COPAXONE 作為品牌可供使用在美國的患者
Kevin C. Mannix - Head of Global IR
Kevin C. Mannix - Head of Global IR
Before we take the next question, Kalem, I think, we had a question for Hafrun regarding levo and an application for that.
在我們回答下一個問題之前,Kalem,我想,我們有一個關於 levo 的問題要問 Hafrun 並提出申請。
Hafrun Fridriksdottir - EVP & President of Global Generics R&D
Hafrun Fridriksdottir - EVP & President of Global Generics R&D
Yes, so levothyroxine is, of course, aproduct with no patent blocks,so we don't really see any information about it.
是的,所以左甲狀腺素當然是沒有專利塊的產品,所以我們真的看不到任何關於它的信息。
We do not comment on ANDAs against products with no patent blocks.
我們不對沒有專利塊的產品評論 ANDA。
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
I think the question was around, whether the revenues that we are forecasting for the new products, for the rest of the year, are they based on date-certain?
我認為問題是,我們對新產品的收入預測,在今年餘下的時間裡,它們是否基於確定的日期?
Yes, the answer is to that question.
是的,答案就是這個問題。
The key launches that we have in quarter 4, that are going to materialize are primarily in December.
我們在第 4 季度推出的主要產品將在 12 月實現。
And these are the generics of Viagra, generics of Reyataz, and generics of Viread.
這些是偉哥的仿製藥、Reyataz 的仿製藥和 Viread 的仿製藥。
So that is where the predominant part of our quarter 4 new product launch revenues are concentrated.
這就是我們第四季度新產品發布收入的主要部分集中的地方。
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
When it comes to the price and volume erosion on the other parts of the business, we are seeing a volume erosion, hitting pretty hard on the Concerta-authorized generic.
當談到業務其他部分的價格和銷量侵蝕時,我們看到了銷量侵蝕,對 Concerta 授權的仿製藥造成了相當大的打擊。
And the price erosion that we see on the transition products is slightly higher than that we see on the base, just by the nature of the products because they're going from exclusivity to a non-exclusivity situation.
我們在過渡產品上看到的價格侵蝕略高於我們在基礎產品上看到的,這取決於產品的性質,因為它們正在從排他性轉變為非排他性。
Next question.
下一個問題。
Operator
Operator
Your next question is from the line of Ken Cacciatore from Cowen & Co.
您的下一個問題來自 Cowen & Co. 的 Ken Cacciatore。
Kenneth Charles Cacciatore - MD and Senior Research Analyst
Kenneth Charles Cacciatore - MD and Senior Research Analyst
Just have 2 quick questions.
只需提出 2 個快速問題。
I know you're all going to be talking about setting the stage for 2018 a little bit later.
我知道你們都將談論稍後為 2018 年做準備。
But can you just remind us in where we stand with your previously discussed R&D and SG&A kind of cost reductions?
但是,您能否提醒我們在您之前討論的研發和 SG&A 成本降低方面我們的立場?
Just where we are in that plan and maybe just reframe that for us.
正是我們在那個計劃中的位置,也許只是為我們重新構建它。
And then on AUSTEDO just wondering if there is anything you can do in the marketplace, kind of willingness to be flexible with managed care to make sure that you're able to properly participate in what does look to be an interesting TD market given Neurocrine's report.
然後在 AUSTEDO 上,只是想知道您是否可以在市場上做任何事情,願意在管理式護理方面保持靈活,以確保您能夠正確參與根據 Neurocrine 的報告看起來很有趣的 TD 市場.
So can you just give us a little bit of the pushes and pulls on how, maybe, from a managed care pricing perspective, you can ensure that you're there in a meaningful way?
那麼,您能否給我們一些推動和拉動,也許,從管理式醫療定價的角度來看,您可以確保您以一種有意義的方式在那裡?
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
Ken, I'll address, first, the cost-savings.
肯,我首先要談的是節省成本。
So we laid out plans for synergies in cost savings for the year.
因此,我們制定了本年度成本節約協同效應的計劃。
At the Q2 results, we mentioned we would be at $1.6 billion by the end of this year in terms of synergies and cost savings versus the pro forma.
在第二季度的業績中,我們提到到今年年底,與備考相比,我們的協同效應和成本節約將達到 16 億美元。
We are on track to meet that.
我們有望實現這一目標。
Some of that will carry over to next year.
其中一些將延續到明年。
But we will -- when we build our 2018 plan, have to look at further efficiencies and things we can do to sharpen up the business.
但我們會——當我們制定 2018 年計劃時,必須著眼於進一步的效率和我們可以做些什麼來加強業務。
I'll remind you of that $1.6 billion of savings, there have been some reinvestments on the other side of the business in terms of some R&D expenses and other things.
我會提醒你,節省了 16 億美元,在一些研發費用和其他方面,業務的另一端已經進行了一些再投資。
So we will see the majority of that coming through to the bottom line versus a pro forma.
因此,我們將看到其中的大部分都進入了底線,而不是備考。
And we will continue the cost-saving efforts as we go into next year, focusing on the priorities of the business that we will be building together in the 2018 plan with Kåre.
進入明年,我們將繼續努力節省成本,重點關注我們將在 2018 年計劃中與 Kåre 共同打造的業務優先事項。
Robert Koremans - President & CEO of Global Specialty Medicines Group
Robert Koremans - President & CEO of Global Specialty Medicines Group
And Ken, on your question on AUSTEDO.
肯,關於你關於 AUSTEDO 的問題。
Yes, I fully agree, it's an exciting opportunity, the TD and also Huntington's look good, like I said before, performing well.
是的,我完全同意,這是一個令人興奮的機會,TD 和亨廷頓的看起來都不錯,就像我之前說的,表現很好。
One of the key things will be to get psychiatrists, who've not been used to prescribe products like this to educate them.
關鍵的事情之一是讓精神科醫生,他們沒有被用來開這樣的產品來教育他們。
And if there is not enough, say, prescription, it is also difficult for payers to really take it and list it high.
如果沒有足夠的處方,比如處方,付款人也很難真正服用並列在高位。
And we do everything.
我們什麼都做。
And obviously, are open also for more innovative approaches.
顯然,也對更多創新方法持開放態度。
And actually, we have been talking to many of our payers on programs like that.
實際上,我們一直在與我們的許多付款人就此類計劃進行交談。
So far, like I said before, we're really encouraged by the feedback from all stakeholders, patients, physicians and doctors alike both in Huntington's.
到目前為止,就像我之前所說的,我們對來自亨廷頓氏症所有利益相關者、患者、醫生和醫生的反饋感到非常鼓舞。
But we are alone, as you know, tetrabenazine doesn't have an indication there and on tardive dyskinesia.
但我們是孤獨的,如你所知,丁苯那嗪在那裡並沒有跡象表明遲發性運動障礙。
But education is going to be really important to really make sure that we get to the full potential there.
但是教育對於真正確保我們在那裡充分發揮潛力非常重要。
Michael McClellan - Senior VP & Interim CFO
Michael McClellan - Senior VP & Interim CFO
Kalem, we'll take 1 last question.
卡萊姆,我們將回答最後一個問題。
Operator
Operator
Last question is from the line of David Risinger from Morgan Stanley.
最後一個問題來自摩根士丹利的 David Risinger。
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
I have 3 questions, please.
請問我有3個問題。
The first is, with respect to the ex-U.
首先是關於前U。
S. generic pricing comment, it struck me that pricing has improved, so the comment was low single-digit price erosion ex-U.
美國通用定價評論,讓我印象深刻的是定價有所改善,因此評論是美國前低個位數的價格侵蝕。
S. And I know that years ago, Teva used to talk about mid to high single-digit price erosion ex-U.
S. 我知道幾年前,梯瓦 (Teva) 曾經談論過美國前中高個位數的價格侵蝕。
S. So if you could just provide some more color on that and the improvement in pricing ex-U.
S. 所以如果你能提供更多的顏色和改進前美國的定價。
S.?
S.?
Second, with respect to U.S. pricing, could you just help us understand whether the ECONDISC partnership with WBAD to squeeze generic prices is already in the numbers or when those new contracts are going to be finalized, if not yet reflected?
其次,關於美國的定價,您能否幫助我們了解 ECONDISC 與 WBAD 的合作以擠壓仿製藥價格是否已經存在,或者這些新合同何時最終確定(如果尚未反映)?
And then third, the CGRP patent estate that Teva has may be underappreciated by the market.
第三,Teva 擁有的 CGRP 專利資產可能被市場低估了。
Could you just speak about that, and your asserting of those patents against Lilly and potentially against other CGRP players in the future?
您能否談談這一點,以及您對禮來(Lilly)以及未來可能針對其他 CGRP 參與者的這些專利的主張?
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
Dipankar Bhattacharjee - President & CEO of Global Generic Medicines Group
David, this is Dipankar.
大衛,這是迪潘卡。
I will take the first 2 parts of your question.
我會回答你問題的前兩部分。
So the first is regarding the price erosion environment in the Rest of the World.
首先是關於世界其他地區的價格侵蝕環境。
We really should look at the Rest of the World in 2 parts.
我們真的應該把世界其他地方分為兩部分。
One is the business that we have in Europe and the business that we have in, what would be outside of U.S. and outside of Europe.
一個是我們在歐洲的業務和我們在美國以外和歐洲以外的業務。
Okay, which is, the key markets there would be Japan, other key markets would be Russia, and then we have a nice business in Latin America.
好的,也就是說,主要市場是日本,其他主要市場是俄羅斯,然後我們在拉丁美洲有很好的業務。
As far as the European business is concerned, the prices in Europe -- the generics prices in Europe are already much lower than those in the U.S. Because the price erosion and the compression of prices in Europe started much earlier and they are further down in the cycle.
就歐洲業務而言,歐洲的價格——歐洲的仿製藥價格已經比美國低很多。因為歐洲的價格侵蝕和價格壓縮開始得更早,而且在歐洲價格進一步下降。循環。
So as far as the price erosion is concerned, not just for 2017, for the past, at least, 2 to 3 years, we have seen this stabilize at low single digits.
因此,就價格侵蝕而言,不僅僅是 2017 年,在過去,至少 2 到 3 年,我們已經看到這種情況穩定在低個位數。
And the savings for the payers primarily comes through the savings that happen on the loss of exclusivity of the brand.
付款人的節省主要來自品牌排他性喪失所帶來的節省。
Regarding the business that we have outside of Europe, what I can comment on is that we see price erosion in Japan, in mid-single digits, but in the rest of the countries, we do see stabilization of prices, they are branded generics.
關於我們在歐洲以外的業務,我可以評論的是,我們看到日本的價格下降,處於中個位數,但在其他國家,我們確實看到價格穩定,它們是品牌仿製藥。
And then in some markets, we even see small price increases.
然後在某些市場,我們甚至看到價格小幅上漲。
As far as your second question is concerned, regarding the pricing and the harmonization and alignment because of ECONDISC and WBAD trying to bring their prices at similar levels.
就您的第二個問題而言,關於定價以及協調和調整,因為 ECONDISC 和 WBAD 試圖將它們的價格保持在相似的水平。
The answer for that, whether it's in our numbers or not is, yes, it is.
答案是,無論是否在我們的數字中,是的,是的。
And what we have forecasted as revenues for the rest of the year takes that into account.
我們對今年剩餘時間的收入預測也考慮到了這一點。
David M. Stark - Group Executive VP & Chief Legal Officer
David M. Stark - Group Executive VP & Chief Legal Officer
This is David.
這是大衛。
I'm taking the question on the CGRP patent estate.
我正在回答關於 CGRP 專利權的問題。
So first thing is, we're very pleased with the result that we got in Europe.
所以第一件事是,我們對我們在歐洲獲得的結果感到非常滿意。
So I'd like to talk about results.
所以我想談談結果。
There was a challenge to the patent estate in Europe.
歐洲的專利產業面臨挑戰。
And our main claims came out of that very nicely.
我們的主要主張非常好。
And we're pleased with that result.
我們對這個結果很滿意。
There will be more to come there.
會有更多的人來那裡。
But it's I would say a very positive sign.
但我會說這是一個非常積極的跡象。
I'm not going to comment on our legal strategy in the U.S. You saw that we filed a complaint recently against Lilly in Boston.
我不打算評論我們在美國的法律策略。你看到我們最近在波士頓對禮來公司提出了投訴。
And I won't comment on the legal strategy there.
我不會評論那裡的法律策略。
And, of course, there'll be more to come on that.
而且,當然,還有更多的事情要做。
And we'll keep you updated as matters proceed.
隨著事情的進展,我們會及時通知您。
I think Michael wanted to add something on the science end.
我認為邁克爾想在科學方面添加一些東西。
Michael R. Hayden - President of Global R&D and Chief Scientific Officer
Michael R. Hayden - President of Global R&D and Chief Scientific Officer
Thank you, David.
謝謝你,大衛。
Just to also reemphasize that the claims issued are not just to the ligand, but also to the receptor.
只是為了再次強調所發布的聲明不僅針對配體,還針對受體。
So we do believe we have issued claims that really cover CGRP for the ligand and the receptor, which gives us very broad coverage.
因此,我們確實相信我們已經發布了真正涵蓋配體和受體的 CGRP 的聲明,這為我們提供了非常廣泛的覆蓋範圍。
Kevin C. Mannix - Head of Global IR
Kevin C. Mannix - Head of Global IR
Okay.
好的。
Well, thank you, everybody for joining us today for the call.
好吧,謝謝大家今天加入我們的電話會議。
As always, we'll be available throughout today and coming weeks.
與往常一樣,我們將在今天和未來幾週內提供服務。
We look forward to seeing you and speaking with you.
我們期待見到您並與您交談。
Take care.
小心。
Operator
Operator
Thank you.
謝謝你。
That does conclude the webcast for today.
今天的網絡直播到此結束。
Thank you all for participating.
謝謝大家的參與。
And you may now disconnect.
您現在可以斷開連接。