使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Thank you for standing by.
謝謝你的支持。
Welcome to Teva's conference call.
歡迎來到 Teva 的電話會議。
This conference is being recorded today, Thursday, July 30, 2015.
今天,即 2015 年 7 月 30 日,星期四,錄製了本次會議。
I would like to turn this conference over to your first speaker today, Mr. Kevin Mannix, Senior Vice President and Head of Teva (sic).
我想把這次會議轉交給您今天的第一位發言人,Teva 高級副總裁兼負責人 Kevin Mannix 先生(原文如此)。
Please go ahead.
請繼續。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Thank you, Tracy.
謝謝你,特蕾西。
Good morning, everyone, thank you for joining us today to discuss Teva's second-quarter 2015 financial results.
大家早上好,感謝您今天加入我們討論 Teva 2015 年第二季度的財務業績。
Our President and CEO, Erez Vigodman, will deliver some brief remarks, and then our CFO, Eyal Desheh, will review the results with the slides that can be found on our website.
我們的總裁兼首席執行官 Erez Vigodman 將發表一些簡短的評論,然後我們的首席財務官 Eyal Desheh 將通過我們網站上的幻燈片回顧結果。
The team will then open it up for question-and-answer.
然後團隊將打開它進行問答。
A copy of the slides, as well as this morning's release, can be found on our website under the Investor Relation section, as well as on the Teva Investor Relations app.
可以在我們網站的“投資者關係”部分以及 Teva 投資者關係應用程序上找到幻燈片的副本以及今天上午發布的內容。
Discussions during the call will also include certain financial measures that were not prepared in accordance with generally accepted accounting principles.
電話會議期間的討論還將包括某些未根據公認會計原則準備的財務措施。
Reconciliations of those non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in this morning's press release.
這些非 GAAP 財務指標與最直接可比的 GAAP 財務指標的調節可以在今天上午的新聞稿中找到。
Our presentation contains forward-looking information, which is based on our current beliefs and expectations and involve a number of assumptions, known and unknown risks, and uncertainties that change over time and can cause future results, performance, or achievements to differ materially from the results, performance, or achievements expressed or implied by such forward-looking statements.
我們的演示文稿包含前瞻性信息,這些信息基於我們當前的信念和預期,涉及許多假設、已知和未知的風險以及隨時間變化的不確定性,並可能導致未來的結果、業績或成就與我們的預期存在重大差異此類前瞻性陳述明示或暗示的結果、業績或成就。
We'd ask that you take a moment to read the forward-looking statement legend at the beginning of the presentation, as it contains important information.
我們希望您花點時間閱讀演示文稿開頭的前瞻性聲明圖例,因為它包含重要信息。
With that, I'll now turn the call over to Erez Vigodman.
有了這個,我現在將把電話轉給 Erez Vigodman。
Erez?
埃雷茲?
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Thank you, Kevin.
謝謝你,凱文。
Good morning and good afternoon.
早上好,下午好。
Thank you for joining us today.
感謝您今天加入我們。
We have already been receiving great feedback from our investors and how happy they are in our enthusiasm for the Allergan generic transaction we announced.
我們已經從投資者那裡收到了很好的反饋,他們對我們宣布的 Allergan 非專利交易的熱情感到非常高興。
The conjunction of moves we have conducted during the last 18 months, including this transaction, positions Teva for future growth with very powerful [cylinders] that will fire for us in years to come.
我們在過去 18 個月中採取的一系列舉措(包括此次交易)為 Teva 的未來增長奠定了基礎,其非常強大的 [cylinders] 將在未來幾年為我們火力全開。
We have been creating a leader in the growing genetics industry, including in INN and branded genetics, with an overall product pipeline and product portfolio that leads the industry in terms of differentiation and durability.
我們一直在不斷發展的遺傳學行業(包括 INN 和品牌遺傳學)打造領導者,其整體產品線和產品組合在差異化和耐用性方面引領行業。
We have been developing an emerging late-stage specialty pipeline.
我們一直在開發新興的後期專業管道。
It will generate an exceptional portfolio of specialty products and solutions.
它將產生特殊的專業產品和解決方案組合。
Our [in end] financial profile will enable us to bolster our specialty pipeline and product portfolio in an accelerated manner.
我們的[最終]財務狀況將使我們能夠以加速的方式加強我們的專業管道和產品組合。
We are well-positioned to capture untapped opportunities for greater integration and innovation between genetics and specialty with a single powerful and differentiated offering.
我們處於有利地位,可以通過單一的強大和差異化的產品來抓住遺傳學和專業之間更大整合和創新的未開發機會。
We believe we can deliver even greater value to patients and shareholders, as well as to the healthcare system around the world.
我們相信,我們可以為患者和股東以及世界各地的醫療保健系統提供更大的價值。
We will obtain our financing commitments during the next few days and before August 10 and we expect to close the transaction in the first quarter of 2016.
我們將在未來幾天和 8 月 10 日之前獲得我們的融資承諾,我們預計將在 2016 年第一季度完成交易。
To get into the details of our second-quarter results, I'm turning now the call to Eyal Desheh.
為了詳細了解我們第二季度的業績,我現在將電話轉給 Eyal Desheh。
Eyal Desheh - CFO
Eyal Desheh - CFO
Thank you, Erez.
謝謝你,埃雷茲。
Good morning, good afternoon, everyone.
大家早上好,下午好。
Thank you for joining us.
感謝您加入我們。
As you know, we have already previewed this excellent quarter so let's take a deeper dive into the results.
如您所知,我們已經預覽了這個出色的季度,所以讓我們更深入地了解結果。
Compared to last year, revenues were slightly down in nominal terms, but they were 6% up in real term, driving 16% year-over-year growth in operating income, 15% growth in net income, and 14% growth in earnings per share.
與去年相比,名義收入略有下降,但實際增長6%,帶動營業收入同比增長16%,淨收入增長15%,每股收益增長14%分享。
This was also accompanied by strong cash flow generation.
這也伴隨著強勁的現金流產生。
Foreign exchange continued to impact our top line significantly, reducing sales by $341 million compared to last year, but our natural hedge resulted in minimal impact on our operating income, only $4 million.
外匯繼續顯著影響我們的收入,與去年相比減少了 3.41 億美元的銷售額,但我們的自然對沖對我們的營業收入影響很小,僅為 400 萬美元。
Cash flow.
現金周轉。
Cash flow continues to demonstrate year-over-year improvement, creating adequate resources to support inorganic moves such as the Auspex and Allergan transaction.
現金流繼續顯示出同比改善,創造了足夠的資源來支持 Auspex 和 Allergan 交易等無機動作。
This quarter, we delivered 41% increase in cash flow operation and 51% increase in free cash flow compared to Q2 last year.
本季度,與去年第二季度相比,我們的現金流量增長了 41%,自由現金流量增長了 51%。
When we look at our revenue breakdown by market, the US market is increasing in prominent, reflecting our strong focus on US generics business and a record quarter for Copaxone sales in the United States.
當我們按市場查看我們的收入細分時,美國市場正在顯著增長,反映出我們對美國仿製藥業務的強烈關注以及 Copaxone 在美國的創紀錄季度銷售額。
In addition, foreign exchange had a significant negative impact on our other markets, resulting in our business in the US comprising of 59% of total sales.
此外,外匯對我們的其他市場產生了重大的負面影響,導致我們在美國的業務佔總銷售額的 59%。
Segment revenue breakdown was fairly similar to Q2 last year, though Copaxone increased slightly as percentage of sales.
分部收入細分與去年第二季度非常相似,但 Copaxone 佔銷售額的百分比略有增加。
When we look at the bridge of our quarterly revenues, strong results of our generics driven by the successful launch of aripiprazole, ABILIFY, this quarter, and esomeprazole, NEXIUM, which was launched in Q1, increased it significantly.
當我們審視季度收入的橋樑時,本季度成功推出阿立哌唑 ABILIFY 和第一季度推出埃索美拉唑 NEXIUM 推動了我們仿製藥的強勁業績,顯著增加了收入。
The same goes for the sale of Copaxone in the US this quarter.
本季度 Copaxone 在美國的銷售情況也是如此。
Exchange rates had a significant adverse impact on sale, but not on profit.
匯率對銷售有重大不利影響,但對利潤沒有影響。
Talking about Copaxone.
談論可帕松。
Copaxone sales in the US are in line with expectations, despite the launch of the generic in June.
Copaxone 在美國的銷售符合預期,儘管該仿製藥於 6 月上市。
According to IMS data, demand is holding for Copaxone family, as you can see in the yellow line here on this slide, and we continue to monitor trends in the market very carefully.
根據 IMS 數據,Copaxone 系列的需求保持不變,正如您在這張幻燈片的黃線中所見,我們將繼續非常仔細地監測市場趨勢。
The result of all this is a strong trend of improvement in operating margin for Teva over the past 18 months of almost 500 basis points in operating profit.
所有這一切的結果是 Teva 的營業利潤率在過去 18 個月中呈現出強勁的改善趨勢,營業利潤增加了近 500 個基點。
This was built upon the impressive improvement in the profitability of our generic business.
這是建立在我們仿製藥業務盈利能力顯著提高的基礎上的。
As you can see, stepped up for around 20%, 21% a year ago to between 39.5% (sic - see slide 14, "30.5%") to 30% in the first half of 2015.
如您所見,在 2015 年上半年增加了大約 20%、一年前的 21% 到 39.5%(原文如此 - 參見幻燈片 14,“30.5%”)到 30%。
Corporate quarterly operating income, operating income flow, the trend you have seen, with the increasing profits of generics and the MS segment.
公司季度營業收入,營業收入流,你看到的趨勢,隨著仿製藥和 MS 部分利潤的增加。
Our other specialty products have shown lower profitability this quarter resulting from foreign exchange impact, as well as a one-time provision of $26 million, resulting from the situation in Greece.
由於外匯影響以及希臘局勢導致的一次性撥備 2600 萬美元,本季度我們其他專業產品的盈利能力較低。
We anticipate a much stronger second half for this part of our business.
我們預計這部分業務的下半年會更加強勁。
So we've ended the quarter with a robust 16% increase in operating income overall compared to the second quarter last year.
因此,與去年第二季度相比,我們在本季度結束時整體營業收入強勁增長了 16%。
And for the full half, Q2 was a clear continuation of the momentum of Q1, resulting in a very strong first half of the year.
而整個上半年,Q2明顯延續了Q1的勢頭,上半年表現非常強勁。
While foreign exchange rates impacted sales, operating income was up 14% for the first half and earning per share increase by 13%.
雖然匯率影響了銷售額,但上半年營業收入增長了 14%,每股收益增長了 13%。
Free cash flow was up an impressive 64% from the first half of last year.
自由現金流比去年上半年增長了 64%,令人印象深刻。
So we looked at our numbers and at the rest of the year, and based on the strong first half, we are raising guidance, bringing earning per share for the year to the range of $5.15 to $5.40.
因此,我們查看了我們的數字和今年剩餘時間,並基於上半年的強勁表現,我們正在提高指引,使今年的每股收益達到 5.15 美元至 5.40 美元。
And a word on dividend, we also declare a dividend, a quarterly dividend, of $0.34 per share as in last quarter.
關於股息,我們還宣布股息,季度股息,與上一季度一樣為每股 0.34 美元。
This concludes our prepared remarks and I would now like to open the call for your questions.
我們準備好的發言到此結束,現在我想開始徵集大家的問題。
Thank you.
謝謝你。
Operator
Operator
(Operator Instructions)
(操作員說明)
Your first question comes from Liav Abraham.
你的第一個問題來自 Liav Abraham。
Please ask your question.
請提出你的問題。
Liav Abraham - Analyst
Liav Abraham - Analyst
Good morning.
早上好。
First question for Erez, can you comment on whether Paul Bisaro will be joining the Board of Teva following the announcement of the announcement of the acquisition of Allergan generics earlier this week?
埃雷茲的第一個問題,你能否評論保羅比薩羅是否會在本週早些時候宣布收購艾爾建仿製藥後加入梯瓦董事會?
And then a second question for Michael, perhaps on SD-809, I understand that the Phase IB trial in Tourette's was scheduled to complete in the middle of the year, can you confirm that, that's been completed and any commentary on the data?
然後是邁克爾的第二個問題,也許是關於 SD-809,我知道 Tourette 的 IB 期試驗計劃在今年年中完成,你能否確認已經完成以及對數據的任何評論?
We haven't seen a press release?
我們還沒有看到新聞稿?
Thank you very much.
非常感謝。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Good morning, Liav.
早上好,利亞夫。
Not at this stage, and as you know, before we close the deal, we will not provide any more comments on that.
不是在這個階段,正如你所知,在我們完成交易之前,我們不會就此提供更多評論。
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
Hi, Liav.
嗨,利亞夫。
Thank you for your question.
謝謝你的問題。
Yes, just to state, of course, the Tourette's trial has finished as planned, and as indicated to The Street in June.
是的,當然只是聲明,圖雷特氏症的試驗已按計劃完成,正如 6 月份向華爾街報導的那樣。
Just similar to large pharma, we don't usually report on Phase IB data, but this should not be taken as if the results weren't exactly in line with what's expected.
與大型製藥公司類似,我們通常不報告 IB 期數據,但這不應視為結果與預期不完全一致。
We're looking forward to sharing more of this precise data with The Street in the near future at a function where the scientific data can be presented, but we are totally on track and the results were as we hoped for and expected.
我們期待在不久的將來在可以展示科學數據的功能上與 The Street 分享更多此類精確數據,但我們完全走上正軌,結果正如我們所希望和預期的那樣。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Next question?
下一個問題?
Operator
Operator
Thank you.
謝謝你。
The next question comes from the line of Randall Stanicky.
下一個問題來自 Randall Stanicky。
Please ask your question.
請提出你的問題。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Thanks, guys.
多謝你們。
Just a couple.
只是一對。
Erez, one of the things we've talked about over the last couple of days is the fact you can do more specialty deals, really between now and the end of next year, throughout this process.
埃雷茲,我們在過去幾天討論的其中一件事是,在整個過程中,從現在到明年年底,你可以做更多的專業交易。
Can you talk about what the landscape looks like?
你能談談風景是什麼樣的嗎?
How many more opportunities similar to an Auspex or a Labrys do you see and maybe any color that you can provide would be great?
您還看到了多少類似於 Auspex 或 Labrys 的機會,也許您可以提供的任何顏色都很棒?
And then I have a quick follow-up for Siggi?
然後我有一個 Siggi 的快速跟進?
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
We modeled the capacity that is required in order to execute during the 2015/2016 Auspex like this.
我們模擬了在 2015/2016 年 Auspex 期間執行所需的能力。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Are you seeing a lot of opportunities out there?
你看到很多機會嗎?
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Yes, the opportunities.
是的,機會。
We'll assemble the list of targets and opportunities.
我們將匯總目標和機會清單。
There are overtures in a number of phases, but it is to early to provide more comments on that.
在多個階段都有提議,但現在就此提供更多評論還為時過早。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Okay.
好的。
Fair enough.
很公平。
Siggi, I wanted to ask you, we have seen a pick-up in generic approvals out of OGD over the last couple of months.
Siggi,我想問你,在過去的幾個月裡,我們已經看到 OGD 的仿製藥批准數量有所增加。
That could coincide, perhaps, with GDUFA II negotiations.
這可能與 GDUFA II 談判同時發生。
You guys are now set to again have the biggest generic pipeline out there beginning next June when you close the deal.
你們現在準備在明年 6 月完成交易時再次擁有最大的通用管道。
How are you guys thinking about the approvals as we move throughout the GDUFA process?
你們如何看待我們在整個 GDUFA 流程中進行的批准?
Are you expecting a continued increase and can you maybe provide some color on what you guys are modeling?
您是否期待持續增長,您能否為你們正在建模的內容提供一些顏色?
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Randall, on the approval, it's great to see the last few months things are picking up, because earlier in the year, we didn't see so much improvement.
蘭德爾,關於批准,很高興看到過去幾個月的情況有所好轉,因為在今年早些時候,我們沒有看到太大的改善。
Also, I look at it like you indicated in your question.
另外,我就像您在問題中指出的那樣看待它。
We are coming up to the time when we need to negotiate GDUFA again and I expect it to improve.
我們已經到了需要再次談判 GDUFA 的時候了,我希望它會有所改善。
We also have good news from the FDA, especially on two or three fronts.
我們也有來自 FDA 的好消息,尤其是在兩三個方面。
First of all, they have indicated they have resourced better ODD, so they are ready to take on more volume and more reviews.
首先,他們表示他們擁有更好的 ODD 資源,因此他們準備好接受更多的數量和更多的評論。
But also it's not only the volume, they are reviewing more challenging products as the EpiPen, so they have been increasing their expertise on the amount of reviewers.
但不僅僅是數量,他們正在審查更具挑戰性的產品,如 EpiPen,因此他們一直在增加他們在審查人員數量上的專業知識。
And secondly, we are getting more communication from the FDA.
其次,我們正在從 FDA 獲得更多的溝通。
That for us has been a step forward.
這對我們來說是向前邁進了一步。
We, of course, we would like to hear even more than we hear today, but we feel that very strongly, that they want to communicate better with the industry.
當然,我們希望聽到比今天更多的聲音,但我們非常強烈地感覺到,他們希望與行業更好地溝通。
They are [stepping] up to that and that to us is very, very helpful, especially when we are preparing for launches.
他們正在 [加緊] 做到這一點,這對我們非常非常有幫助,尤其是在我們準備發佈時。
So the indicators are right, Randall, and I'm optimistic that going forward this will improve even further.
所以指標是正確的,蘭德爾,我樂觀地認為未來這將進一步改善。
Randall Stanicky - Analyst
Randall Stanicky - Analyst
Got it.
知道了。
That's great, thanks, guys.
太好了,謝謝,伙計們。
Operator
Operator
Thank you.
謝謝你。
The next question comes from the line of Jason Gerberry.
下一個問題來自 Jason Gerberry。
Please ask your question.
請提出你的問題。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
Hi, good morning.
早上好。
Thanks for taking my question.
感謝您提出我的問題。
Just have two.
只要有兩個。
First, can you guys give us an update, your Advair 505(b)(2) program, we are expecting data later this year or so.
首先,你們能不能給我們更新一下,你們的 Advair 505(b)(2) 計劃,我們預計今年晚些時候會得到數據。
This program seems like it would be a good hedge if companies in the space failed to meet the requirements for substitutability.
如果該領域的公司未能滿足可替代性要求,該計劃似乎是一個很好的對沖工具。
So just curious where are you at with that program, if we should get data later this year, and would a go-to-market timing be around the expiry of the Advair patent in August of next year?
所以只是好奇你在那個項目中的位置,如果我們應該在今年晚些時候獲得數據,並且上市時間是否會在明年 8 月 Advair 專利到期前後?
And second, just on the formulary status in the Copaxone market, the expectation was that all the 40 milligram patients would be grandfathered under their previous insurance policy coverage, but that the new RXs would take a hit.
其次,就 Copaxone 市場的處方地位而言,預期所有 40 毫克的患者都將在他們之前的保險政策覆蓋範圍內享受祖父待遇,但新的 RX 會受到打擊。
We are seeing new RXs for Copaxone 40 milligrams down as a percent of total Copaxone new RXs, so just curious how you're seeing the formulary status for Copaxone 40 milligrams shaping up?
我們看到 Copaxone 40 毫克的新 RX 佔 Copaxone 新 RX 總量的百分比下降,所以很好奇您如何看待 Copaxone 40 毫克的處方狀態?
Thanks.
謝謝。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Maybe on Advair 505(b)(2), Michael, you probably are in the best position to talk about that.
也許在 Advair 505(b)(2) 上,邁克爾,你可能最適合談論這個問題。
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
Yes, thanks, Siggi.
是的,謝謝,西吉。
On the 505(b)(2), just to say that our respi generics program, which reflects the strength both in our generic, as well as our specialty portfolio, are working together wonderfully.
關於 505(b)(2),我只想說我們的 respi 仿製藥計劃反映了我們仿製藥和專業產品組合的實力,它們合作得非常好。
Progress is great.
進步很大。
There's of course more than one product, but at this stage I'm not going to release any data on precise timing.
當然有不止一種產品,但在這個階段我不打算發布任何關於精確時間的數據。
But what we can say is that we are going to be very competitive in the space and the group is making outstanding progress, built on the strength of both organizations, the generic and the specialty, where there's tremendous strength in both that adds to this particular development.
但我們可以說的是,我們將在這個領域非常有競爭力,並且該集團正在取得顯著進步,建立在通用和專業兩個組織的力量之上,這兩個組織都有巨大的力量,增加了這個特殊的發展。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Thank you, Michael.
謝謝你,邁克爾。
Rob, please.
羅伯,請。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
Jason, on the 40 milligrams, actually, we have seen a little bit of fluctuation in the [NRX], like you said, but the health plans, in answer to your question, remain very supportive of the 40 milligrams, three times a week.
傑森,關於 40 毫克,實際上,我們已經看到 [NRX] 有點波動,就像你說的,但健康計劃在回答你的問題時仍然非常支持 40 毫克,每週三次.
They see it as really good value, both in terms of the real benefit that it delivers to patients, and we have not seen any change in access for patients there, being very high at 95% of patients having access to this product through payers.
他們認為這是非常好的價值,無論是就它為患者帶來的真正利益而言,我們都沒有看到那裡患者的使用有任何變化,95% 的患者通過付款人獲得該產品的比例非常高。
So we continue to monitor it, obviously, but so far, really see no reaction from the payers from the health plans.
因此,很明顯,我們會繼續對其進行監控,但到目前為止,我們真的沒有看到醫療計劃的付款人有任何反應。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
Thank you.
謝謝你。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Thank you.
謝謝你。
Maybe Rob, something on the TRX trend, during basically the last two weeks?
也許 Rob,基本上是過去兩週的 TRX 趨勢?
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
My pleasure, Erez.
我的榮幸,埃雷茲。
What we have seen is really actually ever since the Glatopa made it to market, a slight increase in both Copaxone 20 and 40, Copaxone 40 being at an all-time high for 18 months, with close to 63,000TRX in the US, and we are really consciously optimistic on everything we are seeing.
我們所看到的實際上是自從 Glatopa 上市以來,Copaxone 20 和 40 都略有增加,Copaxone 40 處於 18 個月以來的歷史新高,在美國接近 63,000TRX,我們真的有意識地對我們所看到的一切持樂觀態度。
It's early days, what you have seen from the generic entry, but all the early indicators are actually making us cautiously optimistic, and what we see both from patients, from physicians, from health plans, is a very strong acceptance to Copaxone 40 and business, reflected by the TRX, which is very nice news.
現在還處於初期階段,您從仿製藥條目中看到的,但所有早期指標實際上都讓我們保持謹慎樂觀,我們從患者、醫生和健康計劃中看到的是對 Copaxone 40 和業務的強烈接受,由 TRX 反映,這是一個非常好的消息。
Jason Gerberry - Analyst
Jason Gerberry - Analyst
Great, thank you.
太好了謝謝。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Next question, Tracy.
下一個問題,特蕾西。
Operator
Operator
The next question comes from David Risinger.
下一個問題來自 David Risinger。
Please ask the question.
請提出問題。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
David.
大衛。
Operator
Operator
David, please ask your question.
大衛,請問你的問題。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Next question, Tracy.
下一個問題,特蕾西。
Operator
Operator
The next question comes from the line of Elliot Wilder (sic).
下一個問題來自 Elliot Wilder (sic) 的台詞。
Please ask your question.
請提出你的問題。
Elliot Wilbur - Analyst
Elliot Wilbur - Analyst
No relation to Gene Wilder.
與吉恩懷爾德無關。
Elliot Wilbur from Raymond James.
雷蒙德·詹姆斯的埃利奧特·威爾伯。
Thanks.
謝謝。
Just a couple of questions on the MS segment, specifically looking at ex-US sales.
關於 MS 細分市場的幾個問題,特別是關於美國以外的銷售。
They have undergone a noticeable dip in the last couple of quarters, down about 35% from the average over the past two years.
他們在過去幾個季度經歷了明顯的下滑,比過去兩年的平均水平下降了約 35%。
Maybe you can just talk about the dynamics there, what's -- how much of that is currency versus other factors and whether or not we should be anticipating a rebound to more normalized levels or at least above the run rate of the last two quarters?
也許你可以談談那裡的動態,什麼是 - 其中有多少是貨幣與其他因素,以及我們是否應該期待反彈到更正常的水平或至少高於過去兩個季度的運行率?
And then just a question on profitability of the MS segment overall.
然後只是一個關於 MS 部分整體盈利能力的問題。
It's something that has been in decline for several quarters now, but this period experienced a very strong rebound and it's the highest rate that you reported in three years or so.
它現在已經下降了幾個季度,但這段時間經歷了非常強勁的反彈,這是你報告的三年左右的最高水平。
It looks like specifically there's been a dramatic reduction in selling and marketing expense in the segment.
看起來特別是該細分市場的銷售和營銷費用大幅減少。
Just wondering how much of that is a short-term phenomenon or whether this is really more now a tactical decision to really scale back on direct promotions, given new competitive dynamics in the space?
只是想知道其中有多少是短期現象,或者考慮到該領域新的競爭動態,這是否真的是一個真正縮減直接促銷的戰術決定?
Thanks.
謝謝。
Eyal Desheh - CFO
Eyal Desheh - CFO
Thank you for your question.
謝謝你的問題。
This is Eyal.
這是埃亞爾。
First of all, the ex-US Copaxone was strongly influenced by exchange rate.
首先,美國前的Copaxone 受匯率影響較大。
We sell in Russia, we sell in Europe.
我們在俄羅斯銷售,我們在歐洲銷售。
Rubel and euro are down year-over-year significantly against the dollar so that has the biggest impact.
盧貝爾和歐元兌美元匯率同比大幅下跌,因此影響最大。
In Russia, we have to remember also, there are tenders, and this quarter there was no tenders, so basically we have a bump each time we have a tender in Russia.
在俄羅斯,我們還必須記住,有招標,而本季度沒有招標,所以基本上每次在俄羅斯進行招標時我們都會遇到一個問題。
It comes between once to twice a year.
每年一次到兩次。
We expect one in the second half of this year.
我們預計今年下半年會有一個。
Regarding the profitability of the MS segment, we've talked about this in the past.
關於 MS 細分市場的盈利能力,我們過去曾討論過。
Gross margin of Copaxone is just under 90%, pretty high and stable.
Copaxone 的毛利率略低於 90%,相當高且穩定。
And then we have a few hundreds of millions of sales and marketing expenses supporting our sales effort in the US and in the international markets, which, of course, are a judgment call based on launches effort and driving sales in the geographies.
然後我們有數億美元的銷售和營銷費用支持我們在美國和國際市場的銷售努力,當然,這是基於推出努力和推動地區銷售的判斷。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Rob, maybe if you'll just say something about, one, Europe, and second, the roll up of the Copaxone 40 milligram in Europe?
羅布,也許你只想說說歐洲,其次,40 毫克 Copaxone 在歐洲的推廣情況?
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
Happy to do so.
很高興這樣做。
Elliot, we have been launching now in seven countries in Europe, Copaxone 40, three times a week, with very good results.
Elliot,我們現在已經在歐洲七個國家推出 Copaxone 40,每週三次,效果非常好。
We are up to 15% conversion in those seven countries, which is well ahead of our plan, actually.
我們在這七個國家的轉化率高達 15%,實際上遠遠超過了我們的計劃。
What we've seen as well in countries like France and Germany, was a fairly strong impact initially in the beginning of the year, end of last year from the orals, Aubagio relatively strong in France, and Tecfidera being relatively strong in Germany and France.
我們在法國和德國等國家也看到了,最初是在年初,去年底從口試中產生了相當大的影響,Aubagio 在法國相對強大,而 Tecfidera 在德國和法國相對強大.
But that is flattening out now, so going forward, we expect to really see benefits from our three times weekly Copaxone launch, as we have seen in the US.
但現在這種情況正在趨於平緩,所以展望未來,我們希望真正看到我們每週三次推出 Copaxone 的好處,就像我們在美國看到的那樣。
Like Eyal said, the majority of the impact you've seen in revenues is really FX related.
正如 Eyal 所說,您在收入中看到的大部分影響實際上與外匯相關。
So for us, Copaxone remains a beautiful opportunity, and ultimately also in Europe, where the position of the authorities versus generics is really different and we believe we have a very strong franchise going forward, specifically with Copaxone 40 three times a week being available in many countries already and coming to more in the near future.
因此,對我們來說,Copaxone 仍然是一個很好的機會,最終在歐洲也是如此,那裡的當局與仿製藥的立場確實不同,我們相信我們擁有非常強大的特許經營權,特別是 Copaxone 40 每週三次上市許多國家已經並將在不久的將來加入更多國家。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
And my last comment here is that just that 2014, we saw the effort to drive up the sales of Copaxone 40 milligram after the successful launch, of course, and we basically are reducing the costs that were associated with the launch during 2015.
我最後的評論是,就在 2014 年,我們看到了成功推出 Copaxone 40 毫克後推動銷量的努力,當然,我們基本上正在降低與 2015 年推出相關的成本。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Next question.
下一個問題。
Operator
Operator
Thank you.
謝謝你。
The next question comes from Manoj Garg.
下一個問題來自 Manoj Garg。
Please ask your question.
請提出你的問題。
Manoj Garg - Analyst
Manoj Garg - Analyst
Hey, thanks for taking the question.
嘿,謝謝你提出這個問題。
Sorry, I didn't realize she was referring to me.
抱歉,我沒意識到她指的是我。
A couple of questions.
幾個問題。
One on Copaxone.
一個在 Copaxone 上。
Appreciate your caller on the 95% access, but as you are having discussions for 2016, are you seeing any changes in carrying status within that access number?
感謝您的來電者獲得 95% 的訪問權限,但是當您討論 2016 年時,您是否看到該訪問號碼的攜帶狀態有任何變化?
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
No payer has indicated any change in market access for 40 milligram or 20 milligram.
沒有付款人表示 40 毫克或 20 毫克的市場准入有任何變化。
Manoj Garg - Analyst
Manoj Garg - Analyst
Okay.
好的。
Great.
偉大的。
And then for Michael, maybe you can review two products for us.
然後對於邁克爾,也許你可以為我們審查兩種產品。
One is just timings of the Phase III for CGRP, and then two, the bendamustine RTU product?
一是 CGRP III 期的時間安排,二是苯達莫司汀 RTU 產品?
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
On the CGRP, as you know, we had the outstanding results.
如您所知,在 CGRP 上,我們取得了出色的成績。
We are the only company that has results for both chronic and episodic migraine.
我們是唯一一家對慢性偏頭痛和發作性偏頭痛都取得結果的公司。
We decided to go to the FDA with both results.
我們決定帶著這兩個結果去 FDA。
This is a meeting that's pending, will happen in the near future.
這是一個懸而未決的會議,將在不久的將來舉行。
We have plans for these particular trials extremely well developed as part of our submission and once we have the meeting with the FDA, we'll be able to continue and develop these as we've planned.
作為我們提交的一部分,我們已經為這些特定的試驗制定了非常完善的計劃,一旦我們與 FDA 會面,我們將能夠按照我們的計劃繼續和開發這些試驗。
But we are looking forward to input from the FDA.
但我們期待 FDA 的意見。
The data, as you well know, was really outstanding.
眾所周知,這些數據非常出色。
Also outstanding, not only in terms of the end points, but also outstanding in terms of the improvements and quality of life of patients.
同樣出色,不僅在終點方面,而且在患者生活質量的改善和質量方面也很出色。
We had a significant -- if you look at just the one assessment of that, which is a MIDAS questionnaire which measures the days with disability over three months, our patients in episodic migraine has a score of 45, in other words, they missed days of work, 45 days.
我們有一個重要的 - 如果你只看一個評估,這是一個 MIDAS 問卷,測量三個月內殘疾的天數,我們的發作性偏頭痛患者的得分為 45,換句話說,他們錯過了幾天工作,45 天。
The only other company who could compare to that used this in the episodic migraine is Amgen.
唯一一家可以與在發作性偏頭痛中使用這種藥物的公司相提並論的是安進公司。
Our improvement was very large, 24 days reduction in disability.
我們的改善非常大,24 天殘疾減少。
Amgen was actually only eight.
安進實際上只有八歲。
So we know that we have a very competitive product, and once we've had our FDA meetings, we'll be informing The Street exact timing, but at this point, we are really awaiting FDA input as to both acceptability of our trial design and our plans for aggressively going forward.
所以我們知道我們有一個非常有競爭力的產品,一旦我們召開了 FDA 會議,我們將通知華爾街確切的時間,但在這一點上,我們真的在等待 FDA 就我們的試驗設計的可接受性提出意見以及我們積極推進的計劃。
Manoj Garg - Analyst
Manoj Garg - Analyst
Great.
偉大的。
And then on the bendamustine partnership?
然後是苯達莫司汀合作夥伴關係?
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Rob, did you want to comment on the Eagle partnerships?
Rob,你想評論 Eagle 的合作夥伴關係嗎?
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
With pleasure.
榮幸。
Rapid infusion bendamustine product has been submitted and we actually expect registration still this year, which we are really waiting for and would be very good news for us indeed.
快速輸注苯達莫司汀產品已經提交,我們實際上預計今年仍會註冊,我們真的在等待,這對我們來說確實是個好消息。
Manoj Garg - Analyst
Manoj Garg - Analyst
Okay, great.
好,太棒了。
Thank you for taking my questions.
謝謝你回答我的問題。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Thank you.
謝謝你。
Next question, Tracy.
下一個問題,特蕾西。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of David Amsellem.
你的下一個問題來自 David Amsellem。
Please ask your question.
請提出你的問題。
Michael Chang - Analyst
Michael Chang - Analyst
Hey, guys.
大家好。
This is Michael on for David.
這是大衛的邁克爾。
Just a few quick follow-ups on bendamustine, actually.
實際上,只需對苯達莫司汀進行一些快速跟進。
First of all, how are you thinking about the rapid infusion for of TREANDA that you licensed from Eagle, and specifically, do you plan a hard switch to that product once it becomes available?
首先,您如何看待您從 Eagle 獲得許可的 TREANDA 的快速輸注,具體來說,您是否計劃在該產品上市後硬切換到該產品?
And then regarding TREANDA currently, what is the extent to which you are still supplying the lyophilized product to customers, given the FDA [warrant] that you got on the liquid product earlier this year?
然後關於目前的 TREANDA,鑑於 FDA [保證] 你今年早些時候獲得了液體產品,你仍在向客戶提供凍乾產品的程度如何?
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Rob, maybe you'll take the first one.
Rob,也許你會拿第一個。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
With pleasure, Michael.
很高興,邁克爾。
Rapid infusion bendamustine is going to be a very important product for both the physicians and doctors.
快速輸注苯達莫司汀將成為醫生和醫生非常重要的產品。
It will take down the infusion time, which helps in the administration, good for patients, and good for the hospitals where they do it.
它將減少輸液時間,這有助於管理,對患者有益,對他們進行治療的醫院也有好處。
We are not going to commit or comment on any -- whether we do a hard switch or not at the moment.
我們不會承諾或評論任何 - 無論我們目前是否進行硬切換。
And maybe the second part of the question, is yes, we still have the [lyophilized] product in the market.
也許問題的第二部分是,是的,我們在市場上仍然有[凍乾]產品。
We have seen that the liquid form has not been well adapted to certain devices that are used for applications, or so called, closed system applicators.
我們已經看到,液體形式並沒有很好地適應某些用於應用程序的設備,或所謂的封閉系統塗抹器。
For those hospitals where these closed are being used, we continue to supply the lyophilized product to the market today.
對於那些正在使用這些封閉產品的醫院,我們今天繼續向市場供應凍乾產品。
Michael Chang - Analyst
Michael Chang - Analyst
All right.
好的。
Thanks, guys.
多謝你們。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Next question.
下一個問題。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Sumant Kulkarni.
你的下一個問題來自 Sumant Kulkarni。
Please ask your question.
請提出你的問題。
Sumant Kulkarni - Analyst
Sumant Kulkarni - Analyst
Thanks for taking my questions.
感謝您回答我的問題。
I have a couple.
我有一對。
Now that Teva is back firmly in the lead on patent challenges in the US, will we also see a return to the more aggressive stance on at-risk launches or has Protonix litigation somehow changed that thinking forever?
既然 Teva 在美國的專利挑戰中穩居領先地位,我們是否還會看到對風險發射採取更激進的立場,或者 Protonix 訴訟是否以某種方式永遠改變了這種想法?
And second, could you quantify for us a new EPS flow?
其次,你能為我們量化一個新的 EPS 流嗎?
It seems like adding Allergan generics should probably give you an elevated [S]?
似乎添加 Allergan 仿製藥應該可以提高 [S]?
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Sumant, it's Siggi here.
Sumant,我是 Siggi。
We are not yet there.
我們還沒有。
We need to close the transaction before we go in the lead again.
在我們再次領先之前,我們需要關閉交易。
But we have an extremely strong IP group.
但我們有一個非常強大的 IP 組。
We look at each and every product on their own merit.
我們根據自己的優點來看待每一種產品。
We -- don't forget that Teva was the leader in this.
我們——不要忘記 Teva 是這方面的領導者。
Teva was the Company that built in a way up, the first to file.
Teva 是一家建立起來的公司,是第一個提交申請的公司。
There was a little bit of change in strategy, and now we are back in the game, with the transaction, with Allergan generics.
戰略發生了一點變化,現在我們又回到了遊戲中,通過交易和艾爾建仿製藥。
So we have, on both sides, both in Teva and Allergan, we have the best IP team there is because there's an expertise both on the brand business and the generic business.
因此,我們在 Teva 和 Allergan 兩邊都有最好的知識產權團隊,因為在品牌業務和通用業務方面都有專業知識。
And we are excited to take it on and get the value out of the transaction.
我們很高興接受它並從交易中獲得價值。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
On the EPS flow, we provided the relevant formation by the end of 2014.
在 EPS 流向上,我們提供了 2014 年底的相關形成。
It pertains to 2015, 2016.
它屬於2015年,2016年。
We said that we'll start to grow top line and bottom line, 2017, [after the] momentum going forward.
我們說過,我們將在 2017 年開始增長收入和利潤,[在] 向前發展的勢頭之後。
We are basically outpacing the targets in 2015, and by the end of 2015, we will be able to integrate the Allergan generic business with Teva's business and to provide more insights that pertain to that.
我們基本上超過了 2015 年的目標,到 2015 年底,我們將能夠將 Allergan 仿製藥業務與 Teva 的業務整合,並提供更多與此相關的見解。
I believe that we'll provide information that meets your expectations.
我相信我們會提供滿足您期望的信息。
Sumant Kulkarni - Analyst
Sumant Kulkarni - Analyst
Thank you.
謝謝你。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Next question.
下一個問題。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from Umer Raffat.
你的下一個問題來自 Umer Rafat。
Please ask your question.
請提出你的問題。
Umer Raffat - Analyst
Umer Raffat - Analyst
Thanks for taking my question.
感謝您提出我的問題。
I have two.
我有兩個。
First one, relatively simple.
第一個,比較簡單。
Has your house view of CGRP market size changed post the PCSK9 pricing we saw last week?
在我們上週看到的 PCSK9 定價之後,您對 CGRP 市場規模的看法是否發生了變化?
And secondly on EBITDA, right now my understanding is Teva EBITDA is about $6 billion.
其次關於 EBITDA,目前我的理解是 Teva EBITDA 約為 60 億美元。
Allergan generics got you about $4.1 billion, so that makes it $10.1 billion.
Allergan 仿製藥為您帶來了大約 41 億美元,因此它達到了 101 億美元。
The slides on Monday mentioned $11.6 billion as being the EBITDA in 2018, meaning between now and 2018, EBITDA goes up something like $2 billion, so I just wanted to understand how you think about the key drivers of $2 billion in EBITDA increase between now and 2018?
週一的幻燈片提到 2018 年的 EBITDA 為 116 億美元,這意味著從現在到 2018 年,EBITDA 增長了大約 20 億美元,所以我只想了解你如何看待從現在到 EBITDA 增長 20 億美元的主要驅動因素2018?
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
So, maybe the first one, Umer, we are okay with $10 billion market at this stage, although we believe that the commercial opportunity is even bigger.
所以,也許第一個,Umer,我們現階段可以接受 100 億美元的市場,儘管我們相信商業機會更大。
We don't think they are good enough tools today to approximate the commercial opportunity here.
我們不認為它們是今天足夠好的工具來估計這裡的商業機會。
So I believe that over time we'll realize that it goes beyond that $10 billion bar and that's something which is good enough, given also the way we see our position and even leading position in that space.
所以我相信,隨著時間的推移,我們會意識到它超過了 100 億美元的門檻,這已經足夠好了,考慮到我們看待自己在該領域的地位甚至領先地位的方式。
Michael, you would like to add to it something?
邁克爾,你想補充點什麼嗎?
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
The one way to look about this is think about the number of people with migraine in the United States.
看待這個問題的一種方法是想想美國偏頭痛患者的數量。
For example, let's just start, [70] million globally, a big, by the way, population in Japan, as well, very frequent.
例如,讓我們開始吧,全球有 [70] 百萬,順便說一句,日本的人口也很大,而且非常頻繁。
In the US, around 40 million, of whom 5 million have chronic migraine.
在美國,大約有 4000 萬人,其中 500 萬人患有慢性偏頭痛。
So the important thing in looking at the market size is firstly thinking about the population that suffers from this and secondly the competitive landscape.
因此,在考察市場規模時,重要的是首先要考慮受此影響的人群,其次是競爭格局。
Certainly besides CGRP a lot of medications are being poorly taken up, not really providing the efficacy and also with some significant side effects.
當然,除了 CGRP 之外,許多藥物的使用率很低,並沒有真正提供療效,而且還有一些明顯的副作用。
So we believe that this whole field will revolutionize the field of migraine, just like statins revolutionized the treatment of high cholesterol.
所以我們相信這整個領域將徹底改變偏頭痛領域,就像他汀類藥物徹底改變高膽固醇的治療一樣。
Then we believe, just looking at the numbers, and also at the present time, the safety of these drugs, early days, but still this has been very safe, particularly for the anti-ligand.
然後我們相信,只看數字,就目前而言,這些藥物的安全性還處於早期階段,但仍然非常安全,尤其是對於抗配體而言。
There's always concerns with the receptor about hepatotoxicity.
人們總是擔心受體的肝毒性。
The market has the potential to be significantly higher than what's stated.
市場有可能大大高於所陳述的水平。
But we will -- obviously lots of studies going on to understand the acceptability, the needs in the patients and not only in the US, but this is huge in Europe and also Japan.
但我們會 - 顯然有很多研究正在進行,以了解患者的可接受性和需求,不僅在美國,而且在歐洲和日本也是如此。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
And Umer, on the second one, $0.7 billion from synergies and the rest is coming from the growth of top line and bottom line of the legacy Teva and Allergan businesses.
而 Umer,在第二個方面,7 億美元來自協同效應,其餘來自傳統 Teva 和 Allergan 業務的頂線和底線的增長。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Tracy, next question.
特蕾西,下一個問題。
Operator
Operator
Your next question comes from Andrew Finkelstein.
你的下一個問題來自 Andrew Finkelstein。
Please ask your question.
請提出你的問題。
Andrew Finkelstein - Analyst
Andrew Finkelstein - Analyst
Thanks very much.
非常感謝。
First of all, for Copaxone as a family, if you think about the glatiramer, you can even include the generic, but what have you seen in terms of how that's doing in share of the MS market, as we have seen some changes in growth dynamics for some of the other products.
首先,對於作為一個家族的 Copaxone,如果你考慮格拉替雷,你甚至可以包括仿製藥,但你看到它在 MS 市場份額方面的表現如何,正如我們看到的一些增長變化一些其他產品的動態。
And then as there is now the three times a week on the market and a less expensive alternative for the 20, does that extend the share that glatiramer takes of the overall MS market?
然後,由於現在市場上有每週 3 次的藥物和 20 次的更便宜的替代品,這是否會擴大格拉替雷在整個 MS 市場中所佔的份額?
And then secondly in the generics business, if you look and around the world, there's strong trends in the US and Latin America.
其次,在仿製藥業務中,如果你放眼全球,就會發現美國和拉丁美洲的趨勢很強勁。
You did note some continued weakness in Japan.
你確實注意到日本的一些持續疲軟。
If you would just give us an update on where things stand there?
您是否願意向我們提供有關目前情況的最新信息?
Thanks.
謝謝。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Mike, maybe you'll take the first one?
邁克,也許你會拿第一個?
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of--
你的下一個問題來自——
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Tracy, no, please let him answer the question.
特蕾西,不,請讓他回答問題。
Operator
Operator
Okay, thank you.
好的謝謝你。
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
Okay, on Copaxone, what we have seen is that the current market share globally for Copaxone is 24%, and that really is all of the brand.
好的,關於 Copaxone,我們所看到的是,Copaxone 目前在全球的市場份額為 24%,這確實是該品牌的全部。
At the moment in the US, the overall market share for the generic is 1.5% in MS and it's under 5% for the overall Copaxone.
目前在美國,仿製藥的總體市場份額在 MS 中為 1.5%,而在整個 Copaxone 中則不到 5%。
What we have seen over the last three years is actually only a relatively small decline of Copaxone, about 4 market share percentage points in the last three years.
過去三年我們看到的其實只是Copaxone的跌幅比較小,最近三年市場份額下降了4個百分點左右。
Going forward, also next year, we believe that for the family of glatiramer acetates this is going to remain relatively stable.
展望未來,也是明年,我們相信對於醋酸格拉默家族來說,這將保持相對穩定。
The orals have made their in-road mostly at cost of [inter from that].
口述的進展主要是以 [inter from that] 為代價的。
Also the markets, per se, have grown, so going forward in terms of the glatiramer rates, we think there's not going to be major, major change in the next 18 months or so.
此外,市場本身也在增長,因此就格拉替雷率而言,我們認為未來 18 個月左右不會發生重大變化。
And Copaxone, we discussed it already before there, we have a good position, doctors and patients and also payers seem to continue to support it, but it's very early days to make very firm statements here.
而 Copaxone,我們之前已經討論過了,我們有一個很好的立場,醫生和患者以及付款人似乎繼續支持它,但現在在這裡發表非常堅定的聲明還為時過早。
We are cautiously optimistic.
我們謹慎樂觀。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Maybe on the generic competition, where we see it, obviously, one player in the US -- there is generics in Latin America.
也許在仿製藥競爭中,我們顯然看到了美國的一個玩家——拉丁美洲有仿製藥。
In some of the markets in Latin America, not nearly all of them, they are getting some market share, it is a locally packed product.
在拉丁美洲的一些市場,並非幾乎所有市場,他們都獲得了一些市場份額,這是一種本地包裝的產品。
In Europe, as we mentioned before, we haven't seen approval for generic Copaxone.
在歐洲,正如我們之前提到的,我們還沒有看到通用 Copaxone 獲得批准。
Russia, there is a pending approval, but no approval as of yet of generic Copaxone.
俄羅斯,仿製藥 Copaxone 有待批准,但尚未獲得批准。
And in Japan, the brand hasn't even launched, so I don't expect generic competition in Japan for some time.
而在日本,該品牌甚至還沒有推出,所以我預計一段時間內日本不會出現仿製藥競爭。
So we are following the landscape well on Copaxone, but so far it's a little bit Latin America and in the US where we see generic Copaxone competition.
因此,我們很好地關注了 Copaxone 的情況,但到目前為止,在拉丁美洲和美國,我們看到了通用 Copaxone 的競爭。
Andrew Finkelstein - Analyst
Andrew Finkelstein - Analyst
Thanks.
謝謝。
But if I could just [call it], the question on Japan was actually for your generics business, except for Copaxone?
但是,如果我可以 [稱之為],關於日本的問題實際上是針對你們的仿製藥業務的,除了 Copaxone?
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
All right, so for my generic business in Latin America, we are doing well.
好吧,對於我在拉丁美洲的通用業務,我們做得很好。
We have been affected by FX a little bit in the market.
我們在市場上受到外彙的影響。
We have a leading position in Chile and Peru.
我們在智利和秘魯處於領先地位。
We are doing well in Argentina.
我們在阿根廷做得很好。
In Brazil, it's mainly Copaxone business, so that's how I can link the two together.
在巴西,主要是 Copaxone 業務,因此我可以將兩者聯繫在一起。
And overall, the Lat Am business is good.
總的來說,拉丁美洲的業務很好。
It's a branded generic business.
這是一個品牌通用業務。
We have been investing in pipeline for the Lat Am market over the last few years, so I'm very pleased there.
過去幾年,我們一直在為拉丁美洲市場投資管道,所以我對此感到非常高興。
In Japan, our profitability is still low.
在日本,我們的盈利能力仍然很低。
We are roughly at around approximately 10% operating profit.
我們的營業利潤率大約在 10% 左右。
If you said, when the overall generics business is at 29% in this quarter, it's very important to turn that around.
如果你說,當本季度整體仿製藥業務佔 29% 時,扭轉這一局面非常重要。
The team is focusing on it.
團隊正在專注於此。
We had the much better launches in June from the Japanese team.
我們在 6 月從日本團隊那裡獲得了更好的發射。
We have our goals in place.
我們有自己的目標。
But we are still under in operating profit in Japan where we want to be going forward.
但是我們在日本的營業利潤仍然很低,我們希望繼續前進。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
So basically, transforming Japan and entering into a number of key growth markets is high on our priority list.
因此,基本上,改造日本並進入一些關鍵增長市場是我們優先考慮的事項。
It is also in line with the five buckets of BD priorities that we shared with the street by the end of 2014 and will execute against it in the course of the next 24 months.
這也符合我們在 2014 年底與街道分享的 BD 優先事項的五個方面,並將在接下來的 24 個月內執行。
Andrew Finkelstein - Analyst
Andrew Finkelstein - Analyst
Thanks very much.
非常感謝。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Next question.
下一個問題。
Operator
Operator
Your next question comes from Ronny Gal.
你的下一個問題來自 Ronny Gal。
Please ask your question.
請提出你的問題。
Ronny Gal - Analyst
Ronny Gal - Analyst
Good morning.
早上好。
Thank you for taking my question.
謝謝你提出我的問題。
I've got two.
我有兩個。
First one on bendamustine.
第一個關於苯達莫司汀。
Rob, can you remind us on the criteria to getting your J-code for this product?
Rob,你能提醒我們獲得該產品的 J 代碼的標準嗎?
And do you guys believe at this point that you'll be in a good position to obtain a J-code separated from the product, or are you just going to go generic?
你們是否相信在這一點上您將處於獲得與產品分離的 J 代碼的有利位置,或者您只是打算通用?
The second one is around human growth hormone.
第二個是圍繞人類生長激素。
You have this product in this market for a while.
你有這個產品在這個市場上有一段時間了。
You started Phase III, but you are not mentioning it a lot.
你開始了第三階段,但你並沒有經常提到它。
Can you give us a (technical difficulty)?
你能給我們一個(技術難度)嗎?
And if I can in a the third one, the CGRP, any chance for a submission based on the Phase II results in the severe patients?
如果我可以在第三個 CGRP 中,是否有機會根據嚴重患者的 II 期結果提交?
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Rob, please, the first one.
Rob,拜託,第一個。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
Ronny, I can take your first one.
羅尼,我可以拿你的第一個。
On the bendamustine rapid infusion, we do expect that we have a good chance to get a separate J-code, but it will be not a time of launch.
關於苯達莫司汀快速輸液,我們確實希望我們有很好的機會獲得單獨的 J 代碼,但這不是上市時間。
It will come a little bit later.
稍後會來。
Gives us a beautiful opportunity to differentiate if that happens, which we would consider to be a nice upside to the products.
如果發生這種情況,給我們一個很好的機會來區分,我們認為這是產品的一個很好的優勢。
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
I'll comment on the albutropin growth hormone deficiency.
我將評論沙丁胺醇生長激素缺乏症。
Of course, this product is doing well.
當然,這個產品做得很好。
We are in Phase III for adults and also Phase II for children.
我們正處於成人 III 期和兒童 II 期。
We are seeing the appropriate response that we expected in terms of improvement of the growth trajectory, also measured by other factors like the ability -- IGF1 levels and both of these studies are proceeding.
我們看到了我們在增長軌跡改善方面預期的適當反應,也通過其他因素衡量,如能力——IGF1 水平,這兩項研究都在進行中。
Recruitment is good and we are on track.
招聘很好,我們正在走上正軌。
The exact plan for commercialization of these products is still under deep discussion at Teva, but I would say the enrollment and the conduct of the studies is going according to plan, with us already seeing significant impact on some of the end points just by seeing the growth trajectory of patients.
這些產品商業化的確切計劃仍在 Teva 深入討論中,但我要說的是,研究的招募和進行正在按計劃進行,我們已經看到對某些終點的重大影響患者的成長軌跡。
So this is a study that is going very well.
所以這是一項進展順利的研究。
Of course, it's a long-acting growth hormone, so it's going to change.
當然是長效生長激素,所以會變的。
It does have significant benefits for patients, but we have to wait the results of these particular studies.
它確實對患者有顯著的好處,但我們必須等待這些特定研究的結果。
On CGRP, again, this is obviously going to be a discussion with the FDA.
同樣,關於 CGRP,這顯然將與 FDA 進行討論。
The results in chronic migraine for such a disabling condition amongst -- compared to quadriplegia and dementia, and above blindness and paraplegia, so this is very significant.
與四肢癱瘓和癡呆症相比,這種致殘性疾病導致慢性偏頭痛,並且高於失明和截癱,所以這是非常重要的。
The results were profound, and of course, part of the discussion will be how quickly can we get this to patients?
結果是深遠的,當然,部分討論將是我們能以多快的速度將其提供給患者?
But at this point, I don't think anybody can predict.
但在這一點上,我認為沒有人能夠預測。
Certainly, it's most likely that the FDA will require a Phase III study that continues to confirm benefit.
當然,FDA 很可能需要進行 III 期研究以繼續確認益處。
Importantly, as part of the study, we do have a dosage, so for us, compared to the competitors, our dosage is sorted out, single injunction at the moment monthly, 275 milligrams.
重要的是,作為研究的一部分,我們確實有一個劑量,所以對我們來說,與競爭對手相比,我們的劑量是經過整理的,目前每月一次,275 毫克。
And that's also helpful to have a minimum dose that really is already established and at the moment given monthly.
這也有助於獲得真正已經確定並且目前每月給予的最低劑量。
Ronny Gal - Analyst
Ronny Gal - Analyst
Thank you.
謝謝你。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Next question.
下一個問題。
Operator
Operator
Your next question comes from the line of David Risinger.
你的下一個問題來自 David Risinger。
Please ask your question.
請提出你的問題。
David Risinger - Analyst
David Risinger - Analyst
Thanks very much.
非常感謝。
Sorry my cell cut out before.
對不起,我的手機之前沒電了。
I have three questions.
我有三個問題。
First, with respect to your CGRP, it seems like this is a product that should get breakthrough therapy status, and once you file it, priority review, but Michael, I was hoping that you could comment on those possibilities?
首先,關於你的 CGRP,這似乎是一個應該獲得突破性治療地位的產品,一旦你提交它,優先審查,但是邁克爾,我希望你能對這些可能性發表評論?
And then second, when do you plan to provide a comprehensive R&D update?
其次,你們計劃什麼時候提供全面的研發更新?
And then finally, with respect to Synthon, it may be launching soon in Europe.
最後,關於 Synthon,它可能很快就會在歐洲推出。
Can you just update us on the timing of when Synthon can launch?
你能告訴我們 Synthon 什麼時候可以發布嗎?
And then separately, what your expectation is in terms of Synthon launch timing?
然後,您對 Synthon 發佈時間的期望是什麼?
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
David, I'll start, and the update will be held before the end of the year.
大衛,我會開始,更新將在年底前舉行。
Michael, CGRP?
邁克爾,CGRP?
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
On CGRP, we are very hopeful for priority review, but we don't know that yet.
在 CGRP 上,我們非常希望優先審查,但我們還不知道。
On breakthrough therapy, whilst this product does have all the criteria that would meet it, generally, the FDA is asking for an active comparator as part of this, which we did not have.
在突破性療法方面,雖然該產品確實具有滿足它的所有標準,但一般來說,FDA 要求提供一種活性比較劑作為其中的一部分,而我們沒有。
We did not expect to get and we recognize that without that comparator this becomes a very difficult discussion.
我們沒想到會得到,而且我們認識到,如果沒有那個比較器,這將成為一個非常困難的討論。
So we expect priority review.
所以我們期待優先審查。
We will not get breakthrough status.
我們不會獲得突破狀態。
And with regard to Synthon, of course, we have been talking a lot about our own product to regulatory authorities all over Europe and there's been tremendous reception.
當然,關於 Synthon,我們一直在向整個歐洲的監管機構談論我們自己的產品,並獲得了巨大的反響。
Synthon and Copaxone are quite different in terms of their impact, for example, on various pathways and also in terms of the protocol-defined end points, these were not fully adhered to.
Synthon 和 Copaxone 在影響方面有很大不同,例如,在各種途徑上,以及在協議定義的終點方面,這些都沒有完全遵守。
I'm not going to make predictions about when Synthon and where it might be approved in Europe, but I would say that certainly the regulatory authorities are very interested in learning about the scientific issues around Synthon and its comparison to Copaxone and these discussions have been undertaken.
我不打算預測 Synthon 何時以及它可能在歐洲獲得批准的地點,但我想說監管機構肯定非常有興趣了解有關 Synthon 的科學問題及其與 Copaxone 的比較,這些討論已經進行。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Thank you.
謝謝你。
Rob, you'd like to add something here?
Rob,你想在這裡添加一些東西嗎?
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
No, Michael said it well.
不,邁克爾說得很好。
It would be pure speculative.
這將是純粹的推測。
What we know is Synthon doesn't have registration as of yet and having seen their data, it doesn't surprise us.
我們所知道的是 Synthon 還沒有註冊,並且看到了他們的數據,這並不讓我們感到驚訝。
Then we are really convinced that in Europe we have a very strong position with 40, three times a week, and our 20.
然後我們真的相信,在歐洲我們有一個非常強大的位置,每週 3 次,40 次,我們的 20 次。
In none of our models Synthon would play a major, major role going forward, but speculation on the timing, I don't think we should do.
在我們的任何一個模型中,Synthon 都不會在未來發揮重要的、重要的作用,但我認為我們不應該對時間進行推測。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Next one.
下一個。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Tracy?
特蕾西?
Operator
Operator
Thank you.
謝謝你。
Your next question comes from David Maris.
你的下一個問題來自 David Maris。
Please ask your question.
請提出你的問題。
David Maris - Analyst
David Maris - Analyst
Just a couple questions.
只是幾個問題。
First, Erez, you had said in your earlier comments that you have been meeting with investors lately and they have been widely supportive and that seems to be evident with the stock.
首先,埃雷茲,你在之前的評論中說過你最近與投資者會面,他們得到了廣泛的支持,這在股票上似乎很明顯。
But maybe has there been any consistent misperception or any pushback and what is your answer to that then?
但也許一直存在任何誤解或任何阻力,那麼您對此的回答是什麼?
Secondly, the other night at the analyst Q&A, someone had asked about the price.
其次,前幾天晚上在分析師問答環節,有人問到了價格。
You gave a very detailed answer on how this feels actually cheaper than the Mylan deal.
你給出了一個非常詳細的答案,說明這實際上比 Mylan 交易便宜。
Maybe f you could run through that again?
也許你能再經歷一遍嗎?
And then lastly, for Siggi or Erez, it seems like you've eliminated the biggest risk to any major M&A with this transaction, in that you know what you're buying given Siggi's long tenure there, just a year ago.
最後,對於 Siggi 或 Erez,似乎你已經通過這次交易消除了任何重大併購的最大風險,因為一年前,鑑於 Siggi 在那裡的長期任期,你知道你要買什麼。
What do you think is -- what is the next biggest risk factor, if we're looking back on this in a couple of years of if things didn't work out.
你認為什麼是下一個最大的風險因素,如果我們在幾年後回顧這件事,如果事情沒有解決。
What are the biggest challenges to a successful integration, eliminating that other risk?
成功整合併消除其他風險的最大挑戰是什麼?
Thank you.
謝謝你。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Thank you, David.
謝謝你,大衛。
Let's start with the price.
讓我們從價格開始吧。
First, it's a fair price, and given the nature of the process, I believe that it's win/win to both parties, as was reflected by the stock performance on day one.
首先,這是一個公平的價格,考慮到這個過程的性質,我相信這對雙方都是雙贏的,正如第一天的股票表現所反映的那樣。
But to dive more into detail there, $2.7 billion is the EBITDA of Allergan generics in 2016 and we provided a number which basically implies less than 15 times EBITDA [margin] for the acquisition.
但要更深入地了解那裡的細節,27 億美元是艾爾建仿製藥在 2016 年的 EBITDA,我們提供的數字基本上意味著收購的 EBITDA [利潤率] 不到 15 倍。
The $82 per share for Mylan implied 15 times EBITDA before [running the price].
Mylan 每股 82 美元意味著 15 倍的 EBITDA [運行價格]。
So, that's one.
所以,這是一個。
Number two, look at the economics that are emanating from the transaction.
第二,看看交易產生的經濟效益。
Year two, more than 20% EPS accretion, year three, more than 20% EPS accretion.
第二年,每股收益增長超過 20%,第三年,每股收益增長超過 20%。
Look also at ROIC and when you look, basically tells it us a very convincing and compelling story about, about how fair is the price that was paid there.
也看看 ROIC,當你看的時候,基本上告訴我們一個非常有說服力和令人信服的故事,關於在那裡支付的價格有多公平。
And when you compare it also to comparison transactions in the space, I believe that you will find out that also here that's a fair price.
當你將它也與空間中的比較交易進行比較時,我相信你會發現這也是一個公平的價格。
On reflections from investors, there is no push back.
根據投資者的反映,沒有退縮。
The converse is true.
反之亦然。
People ask us about time to completion.
人們問我們完成時間。
People ask us about the process with the anti-trust authorities.
人們問我們與反托拉斯當局的程序。
People try to understand how fast we can integrate the business.
人們試圖了解我們整合業務的速度有多快。
People ask us about how fast we can expect the benefits from the business.
人們問我們期望從業務中獲得收益的速度有多快。
People ask us about what is our strategy in genetics, an important discussion by the way, why we believe we can basically develop here a Company that is able to lead and transform the generic space, but these are questions are coming from investors.
人們問我們在遺傳學方面的戰略是什麼,這是一個重要的討論,為什麼我們相信我們基本上可以在這裡發展一家能夠領導和改造仿製藥領域的公司,但這些問題來自投資者。
There is no pushback.
沒有任何阻力。
The converse is true.
反之亦然。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
So David, on the integration, yes, it's true.
所以大衛,關於整合,是的,這是真的。
We're in a special situation of knowing both companies very well.
我們處於非常了解這兩家公司的特殊情況。
First of all, on the Allergan side, it's a good team, known them for a long time.
首先,在 Allergan 方面,這是一支優秀的團隊,他們認識很久了。
They have done great building up the company.
他們在建立公司方面做得很好。
But also keep in mind, Teva has an outstanding team.
但也請記住,Teva 擁有一支出色的團隊。
If you think about the generic team at Teva, they have improved the profitability of the Teva generic business by approximately 1,100 basis points in two years.
如果你想想 Teva 的仿製藥團隊,他們在兩年內將 Teva 仿製藥業務的盈利能力提高了大約 1,100 個基點。
So I want to say we have amazing teams, two of the best teams in the industry on both sides.
所以我想說我們擁有令人驚嘆的團隊,雙方都是業內最好的團隊。
But this is also the biggest risk in the integration because we need to retain the best talent.
但這也是整合中最大的風險,因為我們需要留住最優秀的人才。
We are offering here amazing opportunity.
我們在這裡提供了絕佳的機會。
This will be the fastest growing generic company in the industry.
這將是業內發展最快的仿製藥公司。
We are changing a little bit the dynamics of the generic industry with this new company.
我們正在通過這家新公司稍微改變仿製藥行業的動態。
So we are offering a great challenge.
所以我們提出了一個巨大的挑戰。
But to me, for this to be a successful company, we need to have the best teams.
但對我來說,要成為一家成功的公司,我們需要擁有最好的團隊。
We need to have the winning teams both from Teva and from Allergan generics because, yes, we are buying [tablet presses] and files and things like that, but at the end of the day, the success of this position and of this integration is the human capital.
我們需要來自 Teva 和 Allergan 仿製藥的獲勝團隊,因為,是的,我們正在購買 [壓片機] 和文件之類的東西,但最終,這個職位和這種整合的成功是人力資本。
We are taking this very seriously.
我們非常認真地對待這件事。
We have already kicked off on both sides because we need to focus also on the Teva side, but the Allergan side is very important.
我們已經從雙方開始,因為我們還需要關注 Teva 方面,但 Allergan 方面非常重要。
We have kicked off this part of the preparation for the integration already, this week, same day we signed the deal and even before.
我們已經開始了整合準備的這一部分,本週,我們簽署協議的同一天,甚至更早。
This will be a key focus because people are the essence of the company going forward.
這將是一個重點,因為人是公司前進的本質。
David Maris - Analyst
David Maris - Analyst
Okay.
好的。
Thank you very much.
非常感謝。
Operator
Operator
Thank you.
謝謝你。
The next question comes from the line of Greg Fraser.
下一個問題來自 Greg Fraser。
Please ask your question.
請提出你的問題。
Greg Fraser - Analyst
Greg Fraser - Analyst
Good morning.
早上好。
Thanks for taking the questions.
感謝您提出問題。
It's Greg Fraser on for Gregg Gilbert.
這是格雷格·吉爾伯特的格雷格·弗雷澤。
My first question is on laquinimod.
我的第一個問題是關於拉喹莫德。
Given the possibility that laquinimod could be an ideal add-on therapy to current MS drugs, do you plan to start combo studies at some point, and if so, what other drugs would you include in such studies?
鑑於拉喹莫德可能成為當前 MS 藥物的理想附加療法,您是否計劃在某個時候開始聯合研究,如果是,您會在此類研究中包括哪些其他藥物?
And then on your NTE pipeline, the last time you discussed projections for the pipeline, you predicted risk-adjusted sales of $1 billion to $1.5 billion in 2018 and $3 billion in 2020.
然後在你的 NTE 管道上,你最後一次討論管道的預測時,你預測 2018 年風險調整後的銷售額為 10 億至 15 億美元,2020 年為 30 億美元。
The question is, are those goals still intact?
問題是,這些目標是否仍然完好無損?
Thank you.
謝謝你。
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
Thank you, Greg.
謝謝你,格雷格。
Let me comment on laquinimod.
讓我評論一下拉喹莫德。
Laquinimod is a really remarkable drug, neuromodulary, so it's not an immunosuppressive, but it restores all the disturbed features of inflammation, and particularly, immune regulation that are disturbed, for example, in diseases like MS, restores them to normal without immunosuppression, so these studies are ongoing.
Laquinimod 是一種非常了不起的藥物,神經調節劑,所以它不是免疫抑製劑,但它可以恢復炎症的所有紊亂特徵,特別是,例如,在 MS 等疾病中,免疫調節受到干擾,可以在沒有免疫抑制的情況下將它們恢復正常,所以這些研究正在進行中。
The relapsing remitting study, we've said, has completed enrollment Phase III, and we expect to have a full readout in about the second quarter -- before the end of the second quarter in 2017.
我們已經說過,復發匯款研究已經完成了第三階段的註冊,我們預計將在大約第二季度——即 2017 年第二季度末之前——獲得完整的數據。
Also to say, we are -- laquinimod -- and certainly, even though the animals' models are not great, but certainly in the best animal models there are, and also recent publications in the marmoset, which just is out about a week ago, lauquinimod also -- and these are forms of more progressive MS -- laquinimod has had very significant effects.
另外要說的是,我們是——拉喹莫德——當然,即使動物模型不是很好,但肯定是最好的動物模型,還有關於狨猴的最新出版物,大約一周前才出版, lauquinimod 也——這些是更先進的 MS 的形式——laquinimod 有非常顯著的效果。
We're also looking and have an ongoing trial Phase II of laquinimod in progressive MS, which should read out around the same time as relapsing remitting.
我們也在尋找並正在進行 laquinimod 在進行性 MS 中的 II 期試驗,它應該在復發緩解的同時讀出。
With this major impact on -- and the major impact of laquinimod is on disability, quality of life, and disability progression.
有了這個重大影響——拉喹莫德的主要影響是對殘疾、生活質量和殘疾進展。
It does have impact on inflammatory processes, too with regard to relapse, but the major impact, and certainly in our study on Phase III, this is -- the FDA has changed the rules of the game, first time, putting disability and disability progression as one of the end points of this study through a special protocol agreement with the FDA.
它確實對炎症過程有影響,對複發也有影響,但主要影響,當然在我們對 III 期的研究中,這是 - FDA 改變了遊戲規則,第一次,將殘疾和殘疾進展通過與 FDA 的特別協議協議作為本研究的終點之一。
So this is playing to laquinimod's strengths.
所以這是在發揮 laquinimod 的優勢。
Of course, with this process and this model in place, there is still room for combinations with another drug that would have impact more on relapses and be stronger on relapse without having some of the big effects on brain atrophy and disability that laquinimod has.
當然,有了這個過程和這個模型,仍然有與另一種藥物聯合使用的空間,這種藥物對複發的影響更大,對複發的影響更強,而不會像拉喹莫德那樣對腦萎縮和殘疾產生一些重大影響。
So we, of course, are looking at different combinations, and of course this here Laquinimod (technical difficulty) to [oral] therapy and when we've made that decision, hopefully be this will really something we tell The Street.
因此,我們當然正在研究不同的組合,當然這裡的 Laquinimod(技術難度)到 [口服] 治療,當我們做出決定時,希望這真的會告訴 The Street。
But you can imagine, we're looking at oral therapies.
但你可以想像,我們正在研究口服療法。
Obvious targets are various agents or something like them that have impact on various targets that already have shown to decrease relapse in this particular disease.
明顯的目標是各種藥物或類似的東西,它們對各種目標產生影響,這些目標已經顯示可以減少這種特定疾病的複發。
Now I've forgotten the second part of the question.
現在我忘記了問題的第二部分。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
The other question was on the NTE and our projection for that.
另一個問題是關於 NTE 和我們對此的預測。
What we can say is we don't have any update at this point in time.
我們可以說的是我們目前沒有任何更新。
But if we have, we would come to The Street with it.
但如果我們有,我們會帶著它來到 The Street。
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
Let me just give you, the NTs are a big part of our pipeline.
讓我告訴你,NT 是我們管道的重要組成部分。
We really prefer to think about innovation using existing molecules, but the innovation takes multiple forms.
我們真的更喜歡考慮使用現有分子的創新,但創新有多種形式。
It takes, of course, reformulations, different fixed combinations, as well as even approaches to packaging.
當然,它需要重新配方、不同的固定組合,甚至包裝方法。
Important to note that, for example, we have 11 NTEs by the end of this year.
重要的是要注意,例如,到今年年底我們有 11 個 NTE。
We have 11 NTEs in Phase I, from period of starting this particular program in 2013.
從 2013 年啟動這個特定項目開始,我們在第一階段有 11 個 NTE。
Of these, six are going to go straight to submission, because we need bioequivalence studies.
其中,六個將直接提交,因為我們需要生物等效性研究。
Of these 11, five are going straight to Phase III, so no Phase II studies needed, and these are all going to be submitted on the 505(b)(2) pathway.
在這 11 項中,有五項將直接進入 III 期,因此不需要進行 II 期研究,這些都將提交到 505(b)(2) 途徑。
And the NTE -- this particular program is very much intact, and important to note that with the acquisition of Allergan generics, we will have a bigger pipeline and a bigger number of molecules from which to think about novel combinations, novel ways to deliver, to create value for patients.
而 NTE——這個特定的程序非常完整,重要的是要注意,隨著對 Allergan 仿製藥的收購,我們將擁有更大的管道和更多的分子,從中思考新的組合、新的交付方式,為患者創造價值。
So this program is very much part of our early pipeline and will continue to be enhanced as we look at other innovations in the space between both the generic and the specialty side as we can build and focus on creating value for patients and the healthcare systems that we serve.
因此,該計劃是我們早期管道的重要組成部分,並將繼續得到加強,因為我們可以著眼於通用和專業方面之間空間的其他創新,因為我們可以建立並專注於為患者和醫療保健系統創造價值我們服務。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Next question.
下一個問題。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from the line of Marc Goodman.
你的下一個問題來自馬克古德曼。
Please ask your question.
請提出你的問題。
Marc Goodman - Analyst
Marc Goodman - Analyst
Good morning.
早上好。
First, Siggi, I know you are specifically giving up a lot of top line in Europe to improve profitability.
首先,Siggi,我知道你專門放棄了歐洲的很多頂級產品以提高盈利能力。
So first is can you give us a sense just for the full year, how much revenue do you think you're going to be giving up?
所以首先你能不能給我們一個全年的感覺,你認為你會放棄多少收入?
And after this year, will we be done with that and you'll be of stabilized and back to more growth in Europe?
今年之後,我們是否會完成這些工作,您會穩定下來並恢復歐洲的更多增長?
And how has the profitability improved?
盈利能力如何提高?
You send the press release it's improved.
您發送新聞稿它得到了改進。
Can you give us a sense?
你能給我們一個感覺嗎?
And second question is, there was an earlier comment about Copaxone and not expecting much competition on the branded side anymore.
第二個問題是,之前有關於 Copaxone 的評論,預計品牌方不再有太多競爭。
I was a little curious about your thoughts on the Roche product, which had data that came out recently?
我有點好奇你對最近出數據的羅氏產品的看法?
And then lastly, if you could just talk about Canada.
最後,請您談談加拿大。
You specifically mentioned Canada was weak?
你特別提到加拿大很弱?
Thanks.
謝謝。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Yes, let me start on Europe.
是的,讓我從歐洲開始。
First of all, Europe in -- the only decline in revenue in Europe was FX.
首先,歐洲——歐洲收入唯一下降的是外匯。
They in fact, increased in revenue in second quarter, so we are getting to a stable environment.
事實上,他們在第二季度的收入有所增加,因此我們正在進入一個穩定的環境。
We declined a little bit in first quarter, but our estimation is we are increasing slightly in revenue in Europe.
我們在第一季度略有下降,但我們估計我們在歐洲的收入略有增加。
Obviously, it's difficult to say what the FX will do for the second half of the year, but we don't see any further [cresting] of the pipeline.
顯然,很難說 FX 將在今年下半年做什麼,但我們看不到管道有任何進一步的 [頂峰]。
We have the right mixture.
我們有正確的混合物。
Europe is ahead of schedule in improving their business.
歐洲提前改善了他們的業務。
Their operating profit alone in Europe has improved over 1,000 points, so proportionately in the overall generic business in Teva, the European business has outperformed.
他們僅在歐洲的營業利潤就提高了 1,000 多個點,因此在 Teva 的整體仿製藥業務中,歐洲業務的表現優於大市。
The three markets for stars for me this quarter are Germany, again.
本季度對我來說,三個明星市場仍然是德國。
I mentioned Germany also in first quarter, but Germany again has done extremely well.
我在第一季度也提到了德國,但德國再次表現出色。
Very pleased with the business.
對業務非常滿意。
Our Italian business has improved enormously and is one of the leading businesses in Europe now.
我們的意大利業務有了巨大的進步,現在是歐洲領先的業務之一。
And again, UK has been doing very, very well in our business in Western Europe.
再說一次,英國在我們在西歐的業務中一直做得非常非常好。
So Europe is really getting to the point, and this is what we are saying.
所以歐洲真的到了重點,這就是我們所說的。
This is why the combination with Allergan is so interesting that we see a growth on the top line because we have basically -- we are ready with our own business to integrate with the Allergan business to start to see a growth in the top line because we really are at the right profit level.
這就是為什麼與 Allergan 的合併如此有趣,以至於我們看到了收入的增長,因為我們基本上 - 我們已經準備好將自己的業務與 Allergan 業務整合,開始看到收入的增長,因為我們確實處於合適的利潤水平。
If I also take the Canada question, there was a dip in our Canada results in second quarter.
如果我也考慮加拿大問題,我們在第二季度的加拿大業績有所下降。
Part of that was a one-off item.
其中一部分是一次性物品。
We changed a little bit our return policy, so we had to accrue more for return, simply due to what was in the pipeline.
我們稍微改變了我們的退貨政策,所以我們不得不積累更多的退貨,僅僅是因為管道中的東西。
So part of it was a return.
所以其中一部分是回報。
The second part of the one-off was a settlement with one of our customers, where we had to take a write-off.
一次性付款的第二部分是與我們的一位客戶達成和解,我們不得不註銷。
This was something we had on our books and we closed the settlement.
這是我們賬簿上的事情,我們結束了和解。
The underlying business was a tiny bit weaker due to weaker sales.
由於銷售疲軟,基礎業務略微疲軟。
We saw destocking in the major companies in Canada.
我們看到加拿大主要公司去庫存。
[Marksans] lowered their inventory in Canada in second quarter, but overall, the business itself, the launches are doing well.
[Marksans] 在第二季度降低了他們在加拿大的庫存,但總體而言,業務本身,新品發布表現良好。
For the second half of the year, we assume to be back in business in Canada.
今年下半年,我們假設在加拿大重新開展業務。
We saw this more as a one-off for our Canadian business and they are doing very well.
我們將這更多地視為我們加拿大業務的一次性,他們做得很好。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
On the MS, Michael, you would like to comment?
關於 MS,邁克爾,你想發表評論嗎?
Michael Hayden - President of Global R&D and Chief Scientific Officer
Michael Hayden - President of Global R&D and Chief Scientific Officer
I would just say, the Roche study, Phase III, very interesting, an excellent response.
我只想說,羅氏研究,第三階段,非常有趣,反應很好。
This is due to focusing on another mechanism in multiple sclerosis, B-cell depletion.
這是由於關注多發性硬化症的另一種機制,即 B 細胞耗竭。
It's acting on this particular target and I would say this is great for patients.
它針對這個特定目標起作用,我想說這對患者來說非常好。
It's another approach to looking at ways to modulate the cause of the illness.
這是尋找調節疾病病因的另一種方法。
Of course at Teva, we are very interested in exploring, in development, other approaches to moderate and modulate the cause of the illness.
當然,在 Teva,我們非常有興趣探索和開發其他方法來緩和和調整疾病的原因。
But I would say the Roche results are great for patients, great for systems, in that they do have some impact and it explores a totally different mechanism, which is B-cell depletion.
但我會說羅氏的結果對患者和系統都很好,因為它們確實有一些影響,並且它探索了一種完全不同的機制,即 B 細胞耗竭。
Of course, we're exploring other mechanisms as new data on MS and the pathogenesis and the pathways involved in MS play a role, so we're very deeply in this place, but we see this as a validation of another target in MS, B-cell depletion.
當然,我們正在探索其他機制,因為關於 MS 的新數據以及 MS 的發病機制和通路發揮了作用,所以我們在這個地方非常深入,但我們認為這是對 MS 另一個目標的驗證, B 細胞耗竭。
Kevin Mannix - SVP & Head of Global IR
Kevin Mannix - SVP & Head of Global IR
Last question.
最後一個問題。
Operator
Operator
Thank you.
謝謝你。
Your next question comes from Doug Tsao.
你的下一個問題來自 Doug Tsao。
Please ask your question.
請提出你的問題。
Doug Tsao - Analyst
Doug Tsao - Analyst
Hi, good morning.
早上好。
Thanks for taking the questions.
感謝您提出問題。
Siggi, on the generics business, the operating margin improvement has been quite dramatic for the US business.
Siggi,在仿製藥業務方面,美國業務的營業利潤率提高非常顯著。
Just curious, if we normalize for the launches of NEXIUM and ABILIFY, how much improvement have we actually seen or how much did [weed] get us some excess rent in this quarter, because by my math, you are up 800 basis points on a year-on-year basis, but where are we on a current run rate if we think about those launches?
只是好奇,如果我們對 NEXIUM 和 ABILIFY 的發布進行標準化,我們實際看到了多少改善,或者 [雜草] 在本季度為我們帶來了多少超額租金,因為根據我的數學計算,你上漲了 800 個基點與去年同期相比,但如果我們考慮這些發布,我們目前的運行率在哪裡?
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Yes, so we quickly looked at what we have to be careful of NEXIUM and aripiprazole are really not one-off.
是的,所以我們很快就了解了我們必須注意的 NEXIUM 和阿立哌唑確實不是一次性的。
Especially when you look forward, when we have a combined pipeline, of 110 first-to-files and 320 ANDAs, new launches will not be one-off.
尤其是當你展望未來時,當我們擁有 110 個首次申請和 320 個 ANDA 的組合管道時,新的發布將不會是一次性的。
They will be our business and the main part of the business model.
它們將是我們的業務和業務模型的主要部分。
But to answer your question directly, we probably will be around 26%-plus operating profit.
但直接回答你的問題,我們的營業利潤可能會超過 26%。
This is why we are very comfortable with our goal of 27% for the year.
這就是為什麼我們對今年 27% 的目標感到非常滿意。
We are not raising that.
我們沒有提出這個問題。
We obviously need to focus on the business.
我們顯然需要專注於業務。
But we are really, Doug, we are getting the generic business where we want it to be.
但我們真的,道格,我們正在將通用業務帶到我們想要的地方。
Improvement of about 1,000, 1,100 basis point over two years.
兩年內提高了約 1,000、1,100 個基點。
But the rate without these two products is probably around the 26%-plus operating profit without them.
但如果沒有這兩種產品,營業利潤率可能在 26% 以上左右。
Doug Tsao - Analyst
Doug Tsao - Analyst
Okay.
好的。
Great, thank you.
太好了謝謝。
And then just in terms of Japan, one of your major competitors is taking a little bit of a different model in terms of a partnership with a large brand company.
然後就日本而言,您的主要競爭對手之一在與大型品牌公司的合作夥伴關係方面採取了一些不同的模式。
I know there are a lot of unique dynamics in that market.
我知道那個市場有很多獨特的動態。
Have you ever thought about dramatically changing your go-to-market strategy there?
您是否考慮過大幅改變您的上市策略?
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Yes, we think about all the options we have.
是的,我們考慮了所有的選擇。
We obviously are doing this alone.
我們顯然是單獨做這件事。
There's a challenge in Japan.
日本面臨挑戰。
First of all, the Japanese market, you have to keep in mind that the operating profit of our competitors is not in the 30%s.
首先,日本市場,你要記住,我們競爭對手的營業利潤不在30%左右。
The operating profit of a good generic company in Japan is around 20% in the low 20%s.
日本一家好的仿製藥公司的營業利潤在低 20% 左右,在 20% 左右。
So, we are about half-way there.
所以,我們已經完成了一半。
We need to do better.
我們需要做得更好。
But we are very open minded how we can improve our business.
但我們對如何改善我們的業務持開放態度。
Japan is a very important market to us.
日本對我們來說是一個非常重要的市場。
We think Japan utilization of generics is growing faster in Japan than any other market around the world.
我們認為日本對仿製藥的利用增長速度快於世界上任何其他市場。
Teva has invested significantly in the pipeline.
Teva 已對該管道進行了大量投資。
We are launching on average about 10 products per year.
我們平均每年推出大約 10 種產品。
So we have all the indicators to do a good business and we are very committed to turn this around.
因此,我們擁有開展良好業務的所有指標,並且我們非常致力於扭轉這一局面。
Doug Tsao - Analyst
Doug Tsao - Analyst
Okay.
好的。
Great, thank you very much.
太好了,非常感謝。
Operator
Operator
Thank you.
謝謝你。
I would like to turn the conference back over to Erez Vigodman for final comments.
我想將會議轉回 Erez Vigodman 進行最後評論。
Erez Vigodman - President and CEO
Erez Vigodman - President and CEO
Thank you, everyone, for joining us today, and I look forward to continuing the engagement with you as we make progress with the transaction.
謝謝大家今天加入我們,我期待著在我們取得交易進展的同時繼續與您交流。
Have a good day.
祝你有美好的一天。
Operator
Operator
Thank you.
謝謝你。
That concludes the conference for today.
今天的會議到此結束。
Thank you all for participating.
謝謝大家的參與。
You may all disconnect.
你們都可以斷開連接。