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
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Hello, everyone.
大家好。
I'm Pascal Soriot, CEO of AstraZeneca.
我是阿斯利康首席執行官帕斯卡·索里奧特。
Welcome to this full year and fourth quarter 2016 results presentation for our investors and analysts.
歡迎來到我們為投資者和分析師準備的 2016 年全年和第四季度業績發布會。
We are here live in London and we also have a number of people on the phone and following us on the webcast.
我們在倫敦現場直播,也有很多人打電話並通過網絡廣播關注我們。
For those of you who are online, the presentation can be downloaded from our website.
對於在線的人,可以從我們的網站下載演示文稿。
We plan to spend about 45 minutes on the presentation and we'd like to leave plenty of time for questions and answers, as I'm sure you have a number of questions.
我們計劃用大約 45 分鐘的時間進行演示,並希望留出足夠的時間來提問和回答,因為我確信您有很多問題。
We have about 1.5 hours together.
我們在一起的時間大約為1.5小時。
So if you want to ask questions on the phone, you can get in the queue already now by pressing star one.
因此,如果您想通過電話提問,現在就可以按星號一進入隊列。
There is also an option to ask questions online as part of the webcast.
作為網絡廣播的一部分,還可以選擇在線提問。
Please turn to slide 2; this is our usual forward-looking statement that you have here.
請翻到幻燈片2;這是我們通常的前瞻性聲明。
If we move to slide 3; I'm very pleased today to be joined by Marc Dunoyer, our CFO; Mark Mallon, our Executive Vice President of Global Products and Portfolio Strategy; and Sean Bohen, our EVP of Global Medicines Development and our Chief Medical Officer.
如果我們轉到幻燈片 3;我很高興今天能與我們的首席財務官 Marc Dunoyer 一起參加會議。 Mark Mallon,我們的全球產品和產品組合戰略執行副總裁;以及我們的全球藥品開發執行副總裁兼首席醫療官 Sean Bohen。
So if we move to slide 4, this is the agenda.
因此,如果我們轉到第四張幻燈片,這就是議程。
I'll give you an overview, Mark will cover the growth platforms, the other Marc will cover the financials, Sean the pipeline, and then we'll close and open for Q&A.
我會給你一個概述,馬克將介紹增長平台,另一個馬克將介紹財務,肖恩將介紹管道,然後我們將結束並開始問答。
Moving to slide 5; this is the highlights of the year and the performance in the quarter and the year was in line with our expectations.
轉到幻燈片 5;這是今年的亮點,本季度和全年的表現符合我們的預期。
Total revenue decline in the year reflected, as expected, the loss of exclusivity for Crestor, but also the lack of US FluMist sales this season and, finally, the tail end of the Nexium loss of exclusivity in the United States.
正如預期的那樣,今年總收入的下降反映出 Crestor 失去了獨家經營權,而且反映了本季度美國 FluMist 銷售的缺乏,最後,Nexium 在美國失去了獨家經營權。
What we call the new AstraZeneca, which we define as the three main therapy areas, of course, cancer, cardiovascular, diabetes and respiratory disease, together with the emerging markets, grew by 6% in the year and by 6% in the quarter.
我們所謂的新阿斯利康,我們定義的三個主要治療領域,當然是癌症、心血管、糖尿病和呼吸系統疾病,加上新興市場,今年增長了6%,季度增長了6%。
And we look at this AstraZeneca because it reflects really our strategy of focusing on those core therapy areas and, of course, the emerging markets.
我們之所以關注阿斯利康,是因為它真正反映了我們專注於核心治療領域,當然還有新興市場的戰略。
The emerging markets in particular performed well overall and we delivered an improved performance in the last quarter, and China in particular continues to do very, very well.
新興市場整體表現尤其出色,我們在上個季度的表現有所改善,尤其是中國繼續表現得非常非常好。
Farxiga and Symbicort are global leaders in their market in volume market share and doing very well.
Farxiga 和 Symbicort 是其市場中銷量市場份額的全球領導者,並且表現非常出色。
There was a modest sequential improvement in respiratory for the quarter and we're very pleased with the launch of Bevespi in the US.
本季度呼吸系統略有改善,我們對 Bevespi 在美國的上市感到非常高興。
Mark will talk a little bit more about it, but so far it's been going very well.
馬克會更多地談論它,但到目前為止一切進展順利。
Farxiga is now our largest diabetes medicine and it continued to grow very rapidly; Mark will talk more about it.
Farxiga 現在是我們最大的糖尿病藥物,並且繼續快速增長;馬克將更多地談論它。
It is globally, in volume, again still the number one SGL2 medicine and we believe this class has enormous potential as more data becomes available, and certainly 2017 should continue supporting the class and Farxiga.
從數量上看,它仍然是全球排名第一的 SGL2 藥物,我們相信,隨著更多數據的出現,該類藥物具有巨大的潛力,當然 2017 年應該繼續支持該類藥物和 Farxiga。
Our new star, Tagrisso, reached $423 million in its first 12 months.
我們的新星 Tagrisso 在上市前 12 個月就達到了 4.23 億美元。
It's quite a successful launch for an oncology drug in a third line setting in lung cancer, EGFR-mutated.
這是一種針對 EGFR 突變肺癌三線治療的腫瘤藥物的成功上市。
And we haven't yet launched in China; this product is being fast-tracked from a regulatory approval viewpoint in China and we hope to be able to launch pretty soon.
我們還沒有在中國推出;從中國監管部門的審批角度來看,該產品正在快速推進,我們希望能夠盡快推出。
We're very pleased with the difference it's actually making to patients who have EGFR-mutated lung cancer around the world, and very much and particularly in Asia.
我們對它為世界各地(尤其是亞洲)EGFR 突變肺癌患者帶來的實際效果感到非常高興。
As you know, in Asia 40% to 45% of patients with lung cancer have an EGFR mutation.
如您所知,在亞洲,40% 至 45% 的肺癌患者存在 EGFR 突變。
Our earnings per share were supported by our continued effort on managing SG&A costs and those declined, as we had indicated they would.
我們的每股收益得到了我們在管理銷售、管理及行政費用方面的持續努力的支持,並且正如我們所表明的那樣,這些成本有所下降。
We continue to invest in R&D to support the pipeline, of course.
當然,我們會繼續投資研發來支持產品線。
So in 2017 essentially, we would be starting to annualize the loss of Crestor and finally start seeing the end of this patent cliff that has created enormous headwind for us over the last four years.
因此,從本質上講,到 2017 年,我們將開始將 Crestor 的損失按年計算,並最終開始看到過去四年給我們帶來巨大阻力的專利懸崖的結束。
Just as a quick reminder, 2011 out of close to $30 billion in sales, we had $19 billion in sales coming from products about to lose patent protection.
順便提醒一下,2011 年我們的銷售額接近 300 億美元,其中 190 億美元的銷售額來自即將失去專利保護的產品。
They have, indeed, lost patent protection and they have declined rapidly.
事實上,它們已經失去了專利保護,並且迅速衰落。
By 2018 the great majority of those sales will be gone and that's what we have had to replace and will continue to work to replace.
到 2018 年,這些銷售中的絕大多數都將消失,這就是我們必須更換的產品,並將繼續努力更換。
So turning to page 6; we continue making good progress with the pipeline, as you can see here.
所以翻到第6頁;正如您在此處所看到的,我們繼續在管道方面取得良好進展。
Firstly, and importantly, we received acceptance of our regulatory submission in the US for durvalumab for bladder cancer.
首先,也是重要的是,我們針對膀胱癌的 durvalumab 在美國的監管提交獲得了接受。
This was our first BLA submission and we had, of course, a second one with benralizumab but, importantly, the FDA granted priority review designation to durvalumab in bladder cancer and we look forward to hearing from the FDA over the next period of time.
這是我們提交的第一份BLA 申請,當然,我們還提交了第二份BLA 申請,但重要的是,FDA 授予了durvalumab 治療膀胱癌的優先審評資格,我們期待在接下來的一段時間內收到FDA 的答复。
For Tagrisso we also got priority review designation for AURA3, when we submitted the data.
對於 Tagrisso,當我們提交數據時,我們還獲得了 AURA3 的優先審查指定。
This was our first randomized phase III trial for Tagrisso against chemotherapy.
這是我們第一個針對 Tagrisso 對抗化療的隨機 III 期試驗。
We also received acceptance in Europe.
我們在歐洲也獲得了認可。
And finally, still in oncology, Faslodex which, as we all know, is not a new product but has received the support of new data, Faslodex achieved two regulatory submissions acceptances for 1st-line use in the US and in the UK.
最後,還是在腫瘤學領域,眾所周知,Faslodex 不是一個新產品,但已經得到了新數據的支持,Faslodex 在美國和英國獲得了兩項第一線使用的監管提交接受。
Moving to cardiovascular and metabolic disease, you can see here that the DURATION-7 study combining Bydureon and with basal insulin met its primary endpoint.
轉向心血管和代謝疾病,您可以在此處看到將 Bydureon 與基礎胰島素相結合的 DURATION-7 研究達到了其主要終點。
This is good news and it comes in the wake of the DURATION-8 data which we believe will give us a chance to re-launch Farxiga and Bydureon as we introduce the new pen and should have a substantial impact, hopefully, in 2018 in particular.
這是個好消息,是在DURATION-8 數據發布之後發布的,我們相信,在我們推出新筆時,該數據將為我們提供重新推出Farxiga 和Bydureon 的機會,並有望產生重大影響,尤其是在2018年。
In the respiratory franchise we filed benralizumab, and the filing was accepted both by the FDA and the EU.
在呼吸系統專營權中,我們提交了貝那利珠單抗申請,該申請已被 FDA 和歐盟接受。
This was our second BLA after the other, and we expect benralizumab to make a big difference to the treatment of asthma, but also over time COPD.
這是我們繼另一項BLA 之後的第二個BLA,我們預計貝那利珠單抗將對哮喘的治療產生重大影響,而且隨著時間的推移,對慢性阻塞性肺病(COPD) 的治療也會產生巨大影響。
And finally, outside our three core tiers, together with our partner Lilly, we progressed another shared molecule, MEDI1814, which is a more selective amyloid beta antibody; another good example of the way we actually manage our pipeline, and the way we create value out of our pipelines for partnerships in areas that are not core to the Company.
最後,在我們的三個核心層之外,我們與我們的合作夥伴禮來公司一起開發了另一個共享分子 MEDI1814,這是一種更具選擇性的澱粉樣蛋白 β 抗體;這是我們實際管理渠道的方式以及我們在非公司核心領域的合作夥伴關係中為渠道創造價值的另一個很好的例子。
Moving to slide 7, you see here that staying on the topic of turning points, you can see that we are approaching the time where the loss of Crestor exclusivity will ease the comparison, and that will happen in the second half of 2017.
轉到幻燈片 7,您可以看到,繼續討論轉折點的主題,您可以看到我們正在接近 Crestor 獨家經營權的喪失將緩解比較的時間,這將在 2017 年下半年發生。
In 2016, we saw a large impact from losing Crestor in the US, and we still saw some remnant impact of Nexium, of course, and Seroquel.
2016年,我們看到了在美國失去 Crestor 帶來的巨大影響,當然,我們仍然看到了 Nexium 和思瑞康的一些殘餘影響。
On top of it, we had the impact of FluMist sales that we didn't achieve in the season because of the CDC recommendation not to use FluMist in the US during the season.
最重要的是,我們受到了 FluMist 銷售的影響,但我們在本季度沒有實現這一目標,因為 CDC 建議不要在美國使用 FluMist。
So as we annualized the negative impact of some of these patent expiries, the focus really becomes even stronger on our three main therapy areas as you can see here, oncology, cardiovascular, diabetes, respiratory disease, and they are growing quite nicely together.
因此,當我們對其中一些專利到期的負面影響進行年度統計時,我們對三個主要治療領域的關注確實變得更加強烈,正如您在這裡看到的那樣,腫瘤學、心血管、糖尿病、呼吸系統疾病,並且它們一起發展得相當好。
Oncology, in particular, growing rapidly because of the success of Lynparza, but more importantly the success of Tagrisso.
尤其是腫瘤學,由於 Lynparza 的成功而迅速增長,但更重要的是 Tagrisso 的成功。
Soon enough this will be, hopefully, complemented with the launch of the durvalumab, and also the rollout of the new indications for Faslodex.
很快,durvalumab 的推出以及 Faslodex 新適應症的推出將有望補充這一點。
In CVMD, Brilinta continues to grow and, in fact, we believe that it should be a blockbuster $1 billion-plus next year.
在 CVMD 中,Brilinta 繼續增長,事實上,我們相信明年它的銷售額應該會達到 10 億美元以上。
In the meantime, we have continued to do a fantastic job, from a cost of goods viewpoint, and this product profitability is starting to look pretty good.
與此同時,從商品成本的角度來看,我們繼續做得非常出色,而且該產品的盈利能力開始看起來相當不錯。
In 2017, both Brilinta and Farxiga, actually not only Brilinta but also Farxiga, should be more than $1 billion.
2017年,Brilinta和Farxiga,實際上不僅是Brilinta,還有Farxiga,應該都超過10億美元。
And Farxiga experienced very strong growth in 2016.
Farxiga 在 2016 年經歷了非常強勁的增長。
The respiratory business in 2016 had to face price pressure in the US in particular, but also a little bit in Europe, that affected Symbicort, as you all know.
眾所周知,2016年呼吸系統業務在美國尤其是在歐洲面臨著價格壓力,這對Symbicort產生了影響。
But as we move into 2017, we should see the impact of the launch of Bevespi, and later in the year the launch of benralizumab.
但當我們進入 2017 年時,我們應該會看到 Bevespi 的推出以及今年晚些時候貝那利珠單抗的推出所帶來的影響。
And when we add this together with the emerging markets, we had a growth of about 6% for the year.
當我們將其與新興市場相加時,我們今年的增長率約為 6%。
So if you turn to slide 8, if you look at the opportunities we have, and we focus on the future, we have seen a steady increase in the number of launches from our three main therapy areas; of course, Farxiga, Tagrisso, Lynparza, Duaklir.
因此,如果你翻到幻燈片 8,如果你看看我們擁有的機會,並且我們著眼於未來,我們就會看到我們三個主要治療領域的上市數量穩步增加;當然,Farxiga、Tagrisso、Lynparza、Duaklir。
For the coming year we expect to launch, as you can see here, durvalumab, Qtern, Bevespi which is already launched, and benralizumab in the second part of 2017.
正如您在此處看到的,我們預計明年將推出 durvalumab、Qtern、已經推出的 Bevespi 以及 2017 年下半年推出的 benralizumab。
On top of this exciting launch schedule, we have quite a rich news flow in 2017, as you see on the right-hand side of this chart here.
除了這個激動人心的發布計劃之外,2017 年我們還有相當豐富的新聞流,正如您在此圖表的右側所見。
And we'll have new clinical data coming out for Lynparza, Tagrisso.
我們將公佈 Lynparza 和 Tagrisso 的新臨床數據。
We'll, of course, have the much debated MYSTIC study results, but also we have additional study results beyond MYSTIC.
當然,我們會得到備受爭議的 MYSTIC 研究結果,但我們也會得到 MYSTIC 之外的其他研究結果。
We'll have data supporting Tagrisso, and in lung cancer we have a really great opportunity to build a leadership position in lung cancer with Tagrisso, and with our IO platform.
我們將擁有支持 Tagrisso 的數據,在肺癌領域,我們有一個非常好的機會,可以通過 Tagrisso 和我們的 IO 平台在肺癌領域建立領導地位。
As far as MYSTIC, Sean will talk more about it, but we do remain confident about the potential of this study, and there's nothing new that we have been exposed to that would change our view of the study here, and the potential outcomes.
至於 MYSTIC,Sean 將更多地談論它,但我們確實對這項研究的潛力充滿信心,而且我們所接觸到的任何新東西都不會改變我們對這項研究及其潛在結果的看法。
So if we move to the next slide, slide 9, you can see here that this is why we spend what we spend in R&D.
因此,如果我們轉到下一張幻燈片,即幻燈片 9,您可以在這裡看到,這就是我們在研發上投入資金的原因。
You can see here that we have a very strong pipeline and a lot of assets, a lot of opportunities, to support our growth from 2018 onwards.
您可以在這裡看到,我們擁有非常強大的渠道、大量資產、大量機會,可以支持我們從 2018 年起的增長。
And the question is not whether we will return to growth in 2018 or not, the question is what is going to be the slope of the curve, how fast we will grow.
問題不在於 2018 年我們是否會恢復增長,而是曲線的斜率是多少,我們的增長速度有多快。
Of course, the answer to this is how many of those projects make it, and how strong the clinical data are.
當然,這個問題的答案是有多少項目成功了,以及臨床數據有多強。
On top, of course, we have to deliver a good commercial success, but very much we will know, over the next 12 to 18 months, how many of those projects turn out to be positive; therefore, we'll have a good chance for the slope of the curve as far as the return to growth is concerned.
當然,最重要的是,我們必須取得良好的商業成功,但我們很清楚,在接下來的 12 到 18 個月內,這些項目中有多少是積極的;因此,就增長回報而言,我們將有很好的機會獲得曲線的斜率。
But post 2018, there's clearly no doubt we should be growing.
但 2018 年之後,毫無疑問我們應該增長。
You can see lots of assets, and you can see also a couple of assets outside our core tiers.
您可以看到很多資產,也可以看到我們核心層之外的一些資產。
One is partnered, I have talked about it earlier in Alzheimer's disease with Lilly, and another one anifrolumab we are developing ourselves for Lupus.
一種是合作的,我之前曾與禮來公司在阿爾茨海默病方面討論過,另一種是我們自己開發的用於狼瘡的 anifrolumab。
So before I hand over to Mark Mallon for the growth platform, I'd like to spend one moment to thank all my colleagues around the world, and I know many of them are listening to us.
因此,在我將增長平台移交給馬克·馬龍之前,我想花一點時間感謝我在世界各地的所有同事,我知道他們中的許多人都在傾聽我們的意見。
So I'd like to thank you all for the great work you have done; the progress we have achieved here would not have been possible without your great effort and your commitment to this pipeline, making a difference to patients.
因此,我要感謝大家所做的出色工作;如果沒有你們的巨大努力和對這條管道的承諾,我們就不可能取得今天的進展,為患者帶來改變。
I was, last night, in Cambridge celebrating some of our best scientists, and I can tell you we have an incredibly talented and motivated group of scientists in Cambridge, but also in other parts of the world.
昨晚,我在劍橋慶祝我們一些最優秀的科學家,我可以告訴你,我們在劍橋以及世界其他地方都有一群非常有才華和積極進取的科學家。
So with this, I'll stop here and hand over to Mark.
因此,我將在此停下來並將其移交給馬克。
Thank you.
謝謝。
Mark Mallon - EVP Global Portfolio & Product, Global Medical Affairs, Corporate Affairs & International West
Mark Mallon - EVP Global Portfolio & Product, Global Medical Affairs, Corporate Affairs & International West
Thanks, Pascal, and good afternoon, all of you.
謝謝,帕斯卡,大家下午好。
I'm really pleased to have an opportunity to spend a few moments talking to you about our growth platforms.
我真的很高興有機會花一些時間與您討論我們的增長平台。
And so if we turn to slide 11 we can get started.
因此,如果我們翻到幻燈片 11,我們就可以開始了。
Our growth platforms have really continued to demonstrate overall growth and success in 2017, and that's despite challenges we face with respiratory and the biennial price cuts in Japan.
儘管我們面臨呼吸困難和日本兩年一次的降價挑戰,但我們的增長平台確實在 2017 年繼續展現出整體增長和成功。
The combined revenue of our six growth platforms represents now two-thirds of total revenue, which is an important milestone.
我們六個增長平台的總收入目前佔總收入的三分之二,這是一個重要的里程碑。
And you can see from the chart that we've got great momentum with Brilinta, with emerging markets and actually, in 2016 emerging markets surpassed Europe for sales for the first time.
從圖表中您可以看到,我們在 Brilinta 和新興市場方面取得了巨大的發展勢頭,實際上,2016 年新興市場的銷售額首次超過了歐洲。
And then, of course, with new oncology; a very exciting milestone for us as we're now approaching $1 billion on an annualized basis on sales from our new oncology products.
當然,還有新的腫瘤學;這對我們來說是一個非常令人興奮的里程碑,因為我們新腫瘤產品的年銷售額目前已接近 10 億美元。
If we move to slide 12, what I want to say is, I will just touch on, briefly, emerging markets and Brilinta.
如果我們轉到幻燈片 12,我想說的是,我將簡單地談一下新興市場和 Brilinta。
What I want to do is spend most of the time together focusing on respiratory, diabetes, Japan and new oncology where, I think, maybe most of the questions would be.
我想做的是將大部分時間花在一起關注呼吸、糖尿病、日本和新腫瘤學,我想,也許大多數問題都在這些領域。
Slide 13; so starting first, quickly, on emerging markets.
幻燈片 13;因此,首先、快速地從新興市場開始。
The key message here is, we remain on track for our long-term growth objective of mid to high single digits.
這裡的關鍵信息是,我們仍有望實現中高個位數的長期增長目標。
In fact, you can see from the chart here, we've achieved that both in the fourth quarter and for the year in emerging markets.
事實上,您可以從這裡的圖表中看到,我們在第四季度和今年在新興市場都實現了這一目標。
And this strong performance in the fourth quarter was driven by our growth platforms, by Brilinta, by Forxiga and by respiratory.
第四季度的強勁表現是由我們的增長平台、Brilinta、Forxiga 和 Respiratory 推動的。
We're also excited as we move into 2017 that in China, we're looking at potential approvals for both Tagrisso and Forxiga.
進入 2017 年,我們也很高興看到 Tagrisso 和 Forxiga 在中國的潛在批准。
If we can move to slide 14; moving from emerging markets to respiratory, as Pascal alluded to, 2016 was a significantly challenging year for respiratory.
如果我們可以轉到幻燈片 14;正如帕斯卡所提到的,從新興市場轉向呼吸系統,2016 年對於呼吸系統來說是充滿挑戰的一年。
Respiratory product sales declined 3%, with the main driver of this being Symbicort.
呼吸產品銷售額下降 3%,主要推動因素是 Symbicort。
Now Symbicort, important to remember, continued to maintain volume share leadership in the ICS/LABA class.
現在,值得記住的是,Symbicort 繼續保持著 ICS/LABA 類別中銷量份額的領先地位。
However, product sales were down 10% and this reflected challenges in both the US and Europe, which I'll touch on in a moment.
然而,產品銷量下降了 10%,這反映了美國和歐洲面臨的挑戰,我稍後會談到這一點。
Importantly, outside of US and Europe, we saw a strong growth in emerging markets and the established rest of the world.
重要的是,在美國和歐洲之外,我們看到新興市場和世界其他地區的強勁增長。
Let's talk about the US for a minute.
讓我們談談美國。
In the US, Symbicort product sales declined 18%, but we continue to drive volume growth.
在美國,Symbicort 產品銷量下降了 18%,但我們繼續推動銷量增長。
We saw significant pricing pressure on the ICS/LABA class from managed care, and there was also competition from outside the class, particularly, especially in COPD.
我們看到管理式醫療對 ICS/LABA 類別產生了巨大的定價壓力,並且也存在來自類別之外的競爭,特別是在慢性阻塞性肺病領域。
In regards to 2017, we expect the competitive pressure to moderate only slightly this year, with pricing pressure being the strongest in the first half of the year.
展望2017年,我們預計今年的競爭壓力將略有緩解,其中上半年的定價壓力最為強勁。
Moving to Europe, Symbicort product sales in Europe were down by 12% and we saw a continued pressure from both analog competitors and branded competitors.
轉向歐洲,Symbicort 產品在歐洲的銷量下降了 12%,我們看到來自模擬競爭對手和品牌競爭對手的持續壓力。
However, our business stabilized in Europe during the course of the year and actually, if you look at the overall EU respiratory business, in the fourth quarter we grew that business, which is very encouraging as we head into 2017.
然而,我們在歐洲的業務在這一年中趨於穩定,實際上,如果你看看整個歐盟呼吸系統業務,我們在第四季度實現了該業務的增長,這在我們進入2017 年時非常令人鼓舞。
Wrapping up on emerging markets; delivered 10% growth in respiratory for Symbicort, with China product sales up 32% in China.
總結新興市場; Symbicort 呼吸系統產品銷量增長 10%,中國產品銷量增長 32%。
So in summary, despite the challenges, Symbicort continues to be the leader in the ICS/LABA class in terms of volume share.
總而言之,儘管面臨挑戰,Symbicort 在銷量份額方面仍然是 ICS/LABA 類別中的領導者。
And we believe that their ability to continue to maintain leadership really bodes well for our new products, Bevespi and benralizumab, which will be our first biologics launched in respiratory.
我們相信,他們繼續保持領先地位的能力對於我們的新產品 Bevespi 和 benralizumab 來說確實是個好兆頭,這將是我們在呼吸系統領域推出的首款生物製劑。
I'd also like to point out that we're really pleased that Pulmicort has returned to blockbuster status and achieved $1 billion in sales for the second time in the life of this product; obviously, this being driven by sales largely coming from emerging markets and in particular, China.
我還想指出的是,我們非常高興普米考特重新回到了重磅炸彈的地位,並在該產品的生命週期中第二次實現了 10 億美元的銷售額;顯然,這是由主要來自新興市場,特別是中國的銷售推動的。
And we also wanted to highlight that actually, AstraZeneca is the number one Company in respiratory in emerging markets based on our numbers.
我們還想強調的是,實際上,根據我們的數據,阿斯利康是新興市場呼吸領域排名第一的公司。
Slide 15; I just want to introduce to you Bevespi Aerosphere.
幻燈片 15;我只是想向您介紹貝韋斯皮大氣層。
We're very excited that, as of the first week in January, we have now launched Bevespi Aerosphere in the US.
我們非常高興,從 1 月份的第一周開始,我們已經在美國推出了 Bevespi Aerosphere。
And the initial feedback from physicians is really encouraging and happy to discuss that in the Q&A period.
醫生的初步反饋確實令人鼓舞,並且很高興在問答環節對此進行討論。
And, importantly, we have really good market access for a newly launched product.
而且,重要的是,我們對新推出的產品擁有良好的市場准入。
This is the first and only LAMA/LABA in a pressurized metered dose inhaler and it's the first medicine that's been approved with AstraZeneca and Pearl's unique CO-SUSPENSION Delivery Technology, Aerosphere.
這是第一個也是唯一一個加壓計量吸入器中的 LAMA/LABA,也是第一個獲得阿斯利康和 Pearl 獨特的共懸浮輸送技術 Aerosphere 批准的藥物。
There's no question, the LABA/LAMA class is gaining momentum, supported by a growing body of evidence and evolving guidelines.
毫無疑問,在越來越多的證據和不斷發展的指導方針的支持下,LABA/LAMA 類別正在獲得動力。
Bevespi Aerosphere will differentiate on strong lung function improvement data.
Bevespi Aerosphere 將根據強大的肺功能改善數據進行區分。
And we're going to be building familiarity with this device and technology as we prepare for future products and, in particular, our triple, the PT 10, which could be here in 2019.
當我們為未來的產品,特別是我們的三重產品 PT 10(可能會在 2019 年上市)做準備時,我們將逐漸熟悉該設備和技術。
Moving to slide 16; in the year, diabetes sales grew by 11%, shifting to diabetes, despite the intense competition that I think you're all aware of.
轉到幻燈片 16;今年,儘管競爭激烈,但我想你們都知道,糖尿病銷售額增長了 11%,並轉向糖尿病。
And importantly for us is that we've seen positive growth from all of our regions globally.
對我們來說重要的是,我們看到了全球所有地區的積極增長。
We continue to focus on the fastest growing classes, which is the SGLT2s and GLP-1s, as I think you all know.
我們繼續關注增長最快的類別,即 SGLT2 和 GLP-1,我想你們都知道。
So let me just walk you through some of the key points in our success.
因此,讓我向您介紹我們成功的一些關鍵點。
Our diabetes product sales in the US grew by 5%, despite the intense competition.
儘管競爭激烈,我們在美國的糖尿病產品銷售額仍增長了 5%。
And Europe showed strong growth of 15% in the year, driven by Forxiga.
在 Forxiga 的推動下,歐洲今年呈現出 15% 的強勁增長。
And, finally, emerging markets really impressed with a 25% growth across the franchise, again driven by Forxiga.
最後,新興市場在 Forxiga 的推動下,整個系列實現了 25% 的增長,給人留下了深刻的印象。
Forxiga continued to lead the SGLT2 class with a 42% share globally in volume terms and is now the number one diabetes medicine at AstraZeneca with products sales of $835 million and 72% growth.
Forxiga 繼續引領 SGLT2 類別,以全球銷量計算 42% 的份額,目前是阿斯利康排名第一的糖尿病藥物,產品銷售額達 8.35 億美元,增長 72%。
And I think the middle chart is an important one to look at where you see the stability of Forxiga's volume share, even in the face of growing competition.
我認為中間的圖表很重要,可以看出 Forxiga 銷量份額的穩定性,即使面對日益激烈的競爭。
And certainly, having a $835 million product growing 72% in the year is very exciting.
當然,價值 8.35 億美元的產品在這一年中增長了 72%,這是非常令人興奮的。
And importantly, we are starting to see some further strengthening of the SGLT2 class taking share from the DPP4, which is something we'll be heavily focusing on in 2017.
重要的是,我們開始看到 SGLT2 類別的進一步增強,從 DPP4 手中奪取份額,這是我們 2017 年將重點關注的事情。
In the US, Farxiga outgrew the SGLT2 class.
在美國,Farxiga 的發展速度超過了 SGLT2 級。
Product sales increased 75% in the year in the US, driven by improved market access.
在市場准入改善的推動下,美國的產品銷量今年增長了 75%。
And Farxiga also delivered a strong growth in Europe and emerging markets.
Farxiga 在歐洲和新興市場也實現了強勁增長。
So in summary on Farxiga, we've got a brand that is rapidly moving towards the $1 billion mark, and along with Brilinta, which I'll come to in a moment, will be two new blockbuster medicines for us in 2017.
總而言之,Farxiga 是一個正在迅速邁向 10 億美元大關的品牌,它與 Brilinta 一起(我稍後會談到)將成為我們 2017 年的兩款新的重磅藥物。
A word on Bydureon.
關於 Bydureon 的一句話。
Bydureon delivered a stable product sales performance in 2016 where modest volume growth was offset by price headwinds.
Bydureon 在 2016 年實現了穩定的產品銷售業績,銷量的適度增長被價格逆風所抵消。
We're really excited that we're going to be improving our offering of Bydureon with a new device that is currently approaching submission to the regulatory authorities.
我們非常高興我們將通過一款新設備來改進我們的 Bydureon 產品,該設備目前即將提交給監管機構。
And we look forward to launch in Q2 our saxa/dapa fixed dose combination product in Europe and the US.
我們期待在第二季度在歐洲和美國推出我們的 saxa/dapa 固定劑量組合產品。
Actually, it's now available in the UK and as soon as we get approval in the rest of Europe and US, we'll be launching that.
事實上,它現在在英國上市,一旦我們在歐洲其他地區和美國獲得批准,我們就會推出它。
Slide 17, please.
請幻燈片 17。
Just a few words on Japan; Japan product sales declined by 3%, driven by the mandated biennial price cuts, but we had steady volume growth of about 2%.
簡單介紹一下日本;由於兩年一次的強制降價,日本產品銷量下降了 3%,但銷量穩定增長約 2%。
Our three biggest medicines, Crestor, Nexium and Symbicort, continue to perform well.
我們的三大藥物 Crestor、Nexium 和 Symbicort 繼續表現良好。
We did have Crestor sales impacted by some inventory reductions at our local marketing partner, but those products continue to lead the way in their drug classes.
我們的 Crestor 銷售確實受到了當地營銷合作夥伴庫存減少的影響,但這些產品繼續在其藥物類別中處於領先地位。
And the result of this is that AstraZeneca, if you look at the middle panel there, grew faster than the market, again, in 2016.
結果是,如果你看一下中間的面板,阿斯利康在 2016 年的增長速度再次快於市場。
We've moved up in the rankings in Japan to sixth largest company, up from eighth in 2015, and actually moved up from 12th in 2012.
我們在日本的排名從 2015 年的第八位上升至第六位,實際上也從 2012 年的第十二位上升。
So I think you can see the competitiveness and the capabilities and the impact that our Japan team is having.
所以我認為你可以看到我們日本團隊的競爭力、能力和影響力。
This reflects the impact of, obviously, our lead primary care products, but importantly, the very successful launch of Tagrisso in Japan.
顯然,這反映了我們領先的初級保健產品的影響,但更重要的是,Tagrisso 在日本的推出非常成功。
We launched Tagrisso in May in Japan and we now have over 3,000 patients in Japan treated with Tagrisso.
我們於 5 月份在日本推出了 Tagrisso,目前在日本已有 3,000 多名患者接受 Tagrisso 治療。
Product sales are growing rapidly, as you can see on the chart, totaling $82 million of sales in 2016.
正如您在圖表中看到的那樣,產品銷售額正在快速增長,2016 年銷售額總計 8200 萬美元。
Importantly, a couple of other developments that really will help us in 2017.
重要的是,還有一些其他進展對我們 2017 年確實有幫助。
The treatment guidelines for non-small cell lung cancer in Japan were updated to support Tagrisso use, and in December we had approval for the T790 blood-based test, which will help us drive further identification.
日本非小細胞肺癌的治療指南已更新,以支持 Tagrisso 的使用,12 月,我們獲得了 T790 血液檢測的批准,這將有助於我們推動進一步的識別。
Now, Japan team has already done a fantastic job with the biopsy-based testing; as I say, over 70% testing rate for patients that should be getting the test.
現在,日本團隊已經在基於活檢的測試方面做得非常出色;正如我所說,應該接受檢測的患者檢測率超過 70%。
But getting the blood-based test will obviously further enhance the success we are having in Japan in getting this important medicine to the right patients.
但進行血液檢測顯然將進一步提高我們在日本為正確的患者提供這種重要藥物的成功率。
Slide 18, please, Brilinta.
請幻燈片 18,Brilinta。
Brilinta delivered product sales of $839 million in the year, and has also shown really great growth across all three regions, as we head into 2017.
Brilinta 今年的產品銷售額達到 8.39 億美元,並且在進入 2017 年時,在所有三個地區都顯示出巨大的增長。
We had 45% growth in the US and 15% growth in Europe.
我們在美國的增長率為 45%,在歐洲的增長率為 15%。
Driving that success was changes in competitor labeling in the US, a significant increase in hospital discharge in Europe, and discharge here.
推動這一成功的因素包括美國競爭對手標籤的變化、歐洲出院人數和美國出院人數的顯著增加。
And then we have been rolling out and launching the 60 milligram, and that will continue throughout 2017 as we get reimbursement for the new dose.
然後我們一直在推出 60 毫克劑量,隨著我們獲得新劑量的報銷,這種情況將持續到 2017 年。
We are very optimistic about the future for Brilinta, for several reasons.
出於多種原因,我們對 Brilinta 的未來非常樂觀。
First of all, we do have strong clinical data in coronary artery disease that is getting more and more well appreciated by the cardiovascular community.
首先,我們在冠狀動脈疾病方面確實擁有強有力的臨床數據,這些數據越來越受到心血管界的認可。
The clinical guidelines have been changing steadily towards recognizing the value that Brilinta offers CAD patients, and often now we are seeing that Brilinta is in a preferred position.
臨床指南一直在穩步變化,以認識到 Brilinta 為 CAD 患者提供的價值,現在我們經常看到 Brilinta 處於首選位置。
But there is a growing body, and we will be adding to that, a real, real evidence that is reinforcing the results that we saw in our pivotal trials, and the benefits that Brilinta offers to patients with coronary artery disease.
但這個機構正在不斷壯大,我們將添加一個真實的、真實的證據,以強化我們在關鍵試驗中看到的結果,以及 Brilinta 為冠狀動脈疾病患者帶來的好處。
And reimbursement and access for Brilinta is good, and largely available across the world.
Brilinta 的報銷和使用情況良好,並且在世界各地基本上都可以使用。
Moving to slide number 19, and now turning, not last but let's say in an excited way, to new oncology.
轉到第 19 號幻燈片,現在轉向新的腫瘤學,不是最後,但讓我們以興奮的方式說。
2016 really has been an exciting year for us.
2016 年對我們來說確實是激動人心的一年。
We saw that the new oncology global product sales, which are for us, we're talking about Lynparza and Tagrisso globally, and also sales of Iressa in the US, because Iressa was just recently launched in 2015.
我們看到了新的腫瘤學全球產品銷售情況,對我們來說,我們正在談論 Lynparza 和 Tagrisso 在全球的銷售情況,以及 Iressa 在美國的銷售情況,因為 Iressa 剛剛在 2015 年推出。
Together they were $664 million in the year.
這一年的總收入為 6.64 億美元。
All of these products are based on companion diagnostic tests, so this means that we're really going to be able to focus on getting the medicine to the right patient, where the most benefit will be gained.
所有這些產品都基於伴隨診斷測試,因此這意味著我們真正能夠專注於將藥物提供給正確的患者,從而獲得最大的益處。
And focusing specifically on Tagrisso, really had a strong uptake in the US, Europe and Japan, that I already referenced.
特別關注 Tagrisso,它在美國、歐洲和日本確實有很強的吸引力,我已經提到過。
Global product sales for Tagrisso were $423 million, and we've got 46 regulatory approvals, so the rollout of this product globally has been very rapid.
Tagrisso 的全球產品銷售額為 4.23 億美元,我們已獲得 46 個監管部門的批准,因此該產品在全球的推出速度非常快。
Now underlying US growth slowed, relative in the fourth quarter, relative to the first few quarters, in the US, for Tagrisso.
對於 Tagrisso 來說,目前美國的基本增長相對於第四季度和前幾個季度有所放緩。
And this is because there was an existing pool of T790 patients that was waiting for this treatment.
這是因為現有的 T790 患者正在等待這種治療。
As we're now 12 months into that, some of those people will unfortunately be progressing and obviously, we had that built up demand, as we launched the product.
現在已經過去 12 個月了,不幸的是,其中一些人將會取得進展,顯然,隨著我們推出該產品,我們的需求已經建立起來。
But testing rates in the US are going to continue to grow.
但美國的檢測率將繼續增長。
We're at about the 50% mark, and we're expecting approval -- we'll be leveraging the blood-based test to drive that further.
我們已經完成了大約 50% 的目標,我們正在等待批准——我們將利用基於血液的測試來進一步推動這一目標。
And the same in Europe.
在歐洲也是如此。
Globally, regarding the blood-based test, our partner is rolling to test out across the globe, and so that's going to support the higher testing rates, everywhere.
在全球範圍內,關於血液檢測,我們的合作夥伴正在全球範圍內進行測試,因此這將支持各地更高的檢測率。
And very exciting, as a last point for Tagrisso, and Sean will cover this in a moment, we're looking forward to the approval in the US of the AURA3 study, which has some very exciting data, further demonstrating and confirming the huge patient benefit that Tagrisso offers people with non-small cell lung cancer and have the T790 mutation.
非常令人興奮的是,作為Tagrisso 的最後一點,肖恩將在稍後介紹這一點,我們期待AURA3 研究在美國獲得批准,該研究有一些非常令人興奮的數據,進一步證明和證實了巨大的患者Tagrisso 為非小細胞肺癌患者和具有 T790 突變的患者帶來了好處。
A couple of words on Lynparza, which has also had an exciting year.
關於 Lynparza 的幾句話,該公司也經歷了令人興奮的一年。
Full product sales were $218 million, and again, we saw growth throughout the year, driven by higher testing rates and strong market penetration.
全部產品銷售額為 2.18 億美元,在更高的測試率和強大的市場滲透率的推動下,我們再次看到了全年的增長。
In fact in some markets, including the US, we're actually now close to, or getting closer to, really capturing all the patients that are part of the first indication for Lynparza, the later line ovarian cancer.
事實上,在包括美國在內的一些市場,我們現在實際上已經接近或越來越接近真正捕獲 Lynparza(後線卵巢癌)第一個適應症的所有患者。
But I think we need to remember that Lynparza is the pioneer in PARP technology, in PARP inhibitors.
但我認為我們需要記住,Lynparza 是 PARP 技術和 PARP 抑製劑的先驅。
We are very committed to expanding and continuing to grow Lynparza.
我們非常致力於擴大和持續發展 Lynparza。
First, we've got the strong ovarian SOLO-2 trial data that we'll be leveraging, going forward.
首先,我們已經獲得了強有力的卵巢 SOLO-2 試驗數據,我們將在未來利用這些數據。
And then we've got further label expansion trials outside of ovarian cancer.
然後我們在卵巢癌之外進行了進一步的標籤擴展試驗。
So to conclude, overall we feel we had a solid performance across our growth platforms.
總而言之,總體而言,我們認為我們的增長平台表現穩健。
And achieving the milestone of 63% of our total business coming from the growth platforms is really encouraging as we head forward.
在我們前進的過程中,實現我們總業務 63% 來自增長平台這一里程碑確實令人鼓舞。
And I think it's important to remember is that we're driving this growth, without -- we will be driving this growth, and then adding on top of that, really an exciting pipeline that Pascal referenced, and that now Sean will come up and give you a little bit more detail on.
我認為重要的是要記住,我們正在推動這種增長,而不是——我們將推動這種增長,然後在此基礎上添加帕斯卡提到的真正令人興奮的管道,現在肖恩將會出現,給你更詳細的信息。
So thanks.
那謝謝啦。
Sorry, Marc first, then Sean.
抱歉,先是馬克,然後是肖恩。
Marc Dunoyer - CFO
Marc Dunoyer - CFO
Thanks, Mark, and hello, everyone.
謝謝,馬克,大家好。
I'm going to spend the next few minutes to review the performance of 2016 and I will then move on to the guidance for 2017.
我將用接下來的幾分鐘回顧 2016 年的表現,然後我將轉向 2017 年的指導。
If you want to turn to slide 21; in this first slide, we have the reported P&L performance for the year end, and for the fourth quarter.
如果你想翻到幻燈片21;在第一張幻燈片中,我們報告了年末和第四季度的損益表現。
While core EPS declined in the year, the 9% increase in reported EPS was mainly driven by a credit with respect to the Diabetes Alliance acquisition, reflecting a revaluation of the contingent consideration.
雖然今年核心每股收益有所下降,但報告每股收益增長了 9%,主要是由於收購糖尿病聯盟的信貸所致,反映了或有對價的重估。
Please turn to slide 22.
請翻到幻燈片 22。
Before we get to the core P&L, we have four core adjustment that I would ask you to consider.
在我們討論核心損益之前,我們有四個核心調整,我想請您考慮一下。
About half of our restructuring costs in the year, related to the streamlining of operations and reduction in cost, announced in April last year, we anticipate a full year unrealized net saving from this program of $1.1 billion, in 2018, mostly within SG&A.
去年 4 月宣布,我們今年的重組成本約有一半與精簡運營和降低成本有關,我們預計該計劃 2018 年全年未實現淨節省為 11 億美元,其中大部分用於 SG&A。
The majority of the $1.3 billion of intangible assets amortization was related to the acquisition of Medimmune 10 years ago, as well as the legacy agreement with Merck, regarding part of our US business.
13 億美元無形資產攤銷中的大部分與 10 年前收購 Medimmune 以及與默克公司簽訂的關於我們部分美國業務的遺留協議有關。
And as I mentioned a moment ago, you see a credit in the year, with respect to Diabetes Alliance acquisition, reflecting the revaluation of the contingent consideration.
正如我剛才提到的,您會看到今年有關糖尿病聯盟收購的功勞,反映了或有對價的重估。
The $0.17 that you can see here is, in fact, the net amount between the intangible amortization and the adjustment of the contingent consideration.
您在這裡看到的 0.17 美元實際上是無形攤銷與或有對價調整之間的淨額。
To remind you, the payment stream of royalties to BMS will expire in 2025.
提醒您,BMS 的特許權使用費支付流將於 2025 年到期。
Finally, the [$315 million] of other adjustment partly reflects various legal provision, as well as a discount unwind on the Acerta Pharma option liability.
最後,[3.15 億美元]的其他調整部分反映了各種法律規定,以及 Acerta Pharma 期權責任的折扣解除。
We provide this information because we want to be as transparent as we can, and by showing you the detail of these core adjustments, you can see the value in providing the core as well as reported performance.
我們提供這些信息是因為我們希望盡可能透明,並且通過向您展示這些核心調整的詳細信息,您可以看到提供核心以及報告的性能的價值。
If you can now turn to slide 23.
現在您可以翻到幻燈片 23。
If we look now closely at the core P&L, the total revenue decline of 5% in the year, reflected an 8% fall in product sales, with the effect of losing exclusivity on losing Crestor in the United States, particularly impacting the performance in the second half of the year.
如果我們現在仔細觀察核心損益表,今年的總收入下降了5%,反映出產品銷售額下降了8%,失去獨家經營權對Crestor 在美國的損失產生了影響,特別是影響了在美國的業績。下半年。
Externalization revenue increased by 59%, to $1.7 billion, in line with the commitment I gave at the start of the year.
外部化收入增長了 59%,達到 17 億美元,符合我年初做出的承諾。
Core gross profit declined by 6% in the year, excluding the impact of externalization.
剔除外部化影響,年內核心毛利潤下降6%。
The core gross profit declined by 110 basis point to 82%.
核心毛利潤下降110個基點至82%。
In the fourth quarter, the core gross profit margin declined by 260 basis point to 79%, as we felt the full effect of the loss of Crestor.
第四季度,核心毛利率下降了260個基點至79%,我們感受到了Crestor虧損的全面影響。
Core R&D costs grew by 5% in the year, and was limited to a 2% increase for the fourth quarter.
核心研發成本全年增長5%,第四季度增幅限制在2%。
Core SG&A costs fell by 9% in the year, and by a full 14% in the quarter.
核心 SG&A 成本年內下降了 9%,本季度下降了整整 14%。
I will take you through the details in a moment.
我稍後將向您介紹詳細信息。
The majority of other operating income came through in the quarter, as we continued to sharpen our focus on our key therapy areas.
隨著我們繼續加強對關鍵治療領域的關注,大部分其他營業收入都在本季度實現。
The core EPS performance was flattered by a non-recurring benefit of $0.36, resulting from agreement from transfer pricing between various tax authorities.
核心每股收益的表現因各稅務機關之間轉讓定價協議產生的 0.36 美元的非經常性收益而受到稱讚。
And this benefit helped us deliver the core tax rate of 11%.
這一好處幫助我們實現了 11% 的核心稅率。
For 2017, I expect to return to a tax rate between 16% and 20%.
2017年,我預計稅率將恢復到16%至20%之間。
Please turn to slide 24.
請翻到幻燈片 24。
As I have said many times, cost discipline is a key focus for the business, and we delivered some real achievements in the year.
正如我多次說過的,成本控制是業務的重點,這一年我們取得了一些實實在在的成就。
We did what we said we'd do, and we delivered our commitment and produced the results in line with guidance.
我們言出必行,兌現了承諾,並按照指導產生了結果。
This chart illustrates the good progress we have made in the R&D costs, on the top of this slide, with a 5% increase in the year, reflecting the absorption of costs of ZS Pharma as well as Acerta Pharma.
該圖表顯示了我們在研發成本方面取得的良好進展,在這張幻燈片的頂部,今年增加了 5%,反映了 ZS Pharma 和 Acerta Pharma 的成本吸收。
This compared to 21% increase in the previous year.
與去年相比增長了 21%。
Without ZS Pharma and Acerta Pharma, the core R&D costs would have been declining by 1% in the year.
如果沒有ZS Pharma 和Acerta Pharma,核心研發成本今年將下降1%。
If I look now at the core SG&A costs, the 9% decline reflecting the new AstraZeneca and was driven by efficiency savings in sales and marketing operations, but also further reduction in all general administration areas.
如果我現在看一下核心銷售、管理及行政費用,會發現 9% 的下降反映了新的阿斯利康,並且是由銷售和營銷業務的效率節省以及所有一般管理領域的進一步削減所推動的。
These actions led to the material reduction in the sales and head office structure in the US marketing business.
這些行動導緻美國營銷業務的銷售和總部結構大幅縮減。
Core SG&A cost, as a percentage of total revenue, fell to 35.5%, a decline of 1 percentage point at CER and 2 points at actual rates.
核心 SG&A 成本佔總收入的百分比下降至 35.5%,按固定匯率計算下降 1 個百分點,按實際匯率計算下降 2 個百分點。
If we turn now to slide 25, this covers the R&D cost, and you can see that our investment is stabilizing.
如果我們現在翻到幻燈片 25,這涵蓋了研發成本,您可以看到我們的投資正在穩定。
In line with our commitment to sharpen our focus on our main therapy areas, an increase of investment in oncology, we continue to fund the great science in our pipeline.
根據我們加強對主要治療領域的關注、增加對腫瘤學投資的承諾,我們將繼續資助我們正在研發的偉大科學。
In fact, we have doubled our absolute investment in oncology since 2013, reflecting the exciting opportunity that we have.
事實上,自 2013 年以來,我們對腫瘤學的絕對投資增加了一倍,這反映出我們擁有令人興奮的機會。
We anticipate maintaining the overall level of R&D investment, which leads us to anticipate a similar level of core R&D spend for 2017.
我們預計研發投資的總體水平將保持不變,這使我們預計 2017 年核心研發支出將保持在類似水平。
Please turn to slide 26.
請翻至幻燈片 26。
To conclude, I want to confirm our guidance for 2017, which is at constant exchange rates.
最後,我想確認我們對 2017 年的指導,即按固定匯率計算。
I expect a low to mid single-digit percentage decline in total revenue and core EPS is anticipated to decline by low to mid-teens percentage.
我預計總收入將出現低至中個位數的百分比下降,核心每股收益預計將下降低至中雙位數的百分比。
All of this is subject to our base-case assumptions of the progression of the pipeline and the news flow that Sean will take you through in a moment.
所有這一切都取決於我們對管道進展情況的基本假設以及肖恩稍後將帶您了解的新聞流。
Variation in performance between quarters can be expected to continue, with year-on-year comparison expected to ease in the second half, as we begin to annualize the impact from Crestor.
隨著我們開始對 Crestor 的影響進行年度化,預計各季度之間的業績差異將繼續存在,下半年同比比較預計將有所緩解。
Outside of guidance, the total of externalization revenue and other operating income is expected to be ahead of that in 2016.
除指引外,外部化收入和其他營業收入總額預計將超過 2016 年。
Sustainable and ongoing income is expected to increase as a proportion of external revenue in 2017 and beyond.
預計 2017 年及以後可持續持續收入佔外部收入的比例將會增加。
As I mentioned a moment ago, we anticipate core R&D cost to be broadly in line 2016, and we plan to make further reduction in the core SG&A cost.
正如我剛才提到的,我們預計核心研發成本將與 2016 年大致持平,並且我們計劃進一步降低核心 SG&A 成本。
Finally, I want to reconfirm our capital allocation priorities.
最後,我想再次確認我們的資本配置優先事項。
These are unchanged.
這些都沒有改變。
We will continue to strike a balance between the interests of business, our financial creditors, and our shareholders.
我們將繼續在企業、金融債權人和股東的利益之間取得平衡。
After providing for investment in the business, supporting the progressive dividend policy, and maintaining our strong investment-grade credit ratings, we'll keep under review any potential investment in value enhancing and immediately earnings accretive opportunities.
在提供業務投資、支持累進股息政策並維持我們強大的投資級信用評級後,我們將不斷審查任何潛在的價值提升投資和立即盈利增值機會。
Thank you for listening.
感謝您的聆聽。
I will now hand over to Sean.
現在我將把工作交給肖恩。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Thank you, Marc, and thank you all for joining us, both here and online.
謝謝你,馬克,也感謝大家加入我們,無論是在這裡還是在網上。
It's a great pleasure to be able to share with you our encouraging progress since our last update.
很高興能夠與您分享自上次更新以來我們取得的令人鼓舞的進展。
I would like to emphasize that we're very confident in the molecules and the medicines in the trials underlying our pipeline.
我想強調的是,我們對我們管道中試驗中的分子和藥物非常有信心。
And very enthusiastic about what this year has to bring, as was evidenced by the fact that Mark Mallon wanted to forego Marc Dunoyer's time to do the financial results presentation of the year end results and give that to me.
對今年的成果非常感興趣,馬克·馬倫 (Mark Mallon) 想要放棄馬克·杜諾耶 (Marc Dunoyer) 做年終財務業績演示的時間並將其交給我這一事實就證明了這一點。
So I appreciate that.
所以我很欣賞這一點。
If we can go on to slide 28, please.
請繼續看幻燈片 28。
This slide shows you, looking back at Q4 in 2016, our main pipeline highlights from the therapy areas that we focus on.
這張幻燈片向您展示了 2016 年第四季度的情況,我們重點關注的治療領域的主要產品線亮點。
I'd like to start with oncology.
我想從腫瘤學開始。
Obviously, we're very proud of the US regulatory submission acceptance of durvalumab in bladder cancer.
顯然,我們對美國監管機構接受 durvalumab 治療膀胱癌的申請感到非常自豪。
This is the first ever BLA application for AstraZeneca.
這是阿斯利康的首次 BLA 申請。
And FDA, as we had announced, did award it a priority review designation, so we expect a regulatory decision on durvalumab in bladder cancer in Q2 of this year.
正如我們所宣布的,FDA 確實授予了它優先審評資格,因此我們預計今年第二季度會對 durvalumab 治療膀胱癌做出監管決定。
As Pascal alluded to, the work that people are doing within the Company, the time from data availability to filing was absolutely heroic in this case.
正如帕斯卡提到的,在這種情況下,人們在公司內部所做的工作,從數據可用到歸檔的時間絕對是英雄般的。
So I, too, would like to thank all of the people who dedicate themselves to bringing our medicines to patients.
因此,我也要感謝所有致力於將我們的藥物帶給患者的人們。
We also have US and EU regulatory submission acceptances for Tagrisso on AURA3.
我們還在 AURA3 上接受了美國和歐盟監管機構提交的 Tagrisso。
I'll spend a moment on AURA3.
我將花一點時間討論 AURA3。
We showed that data in December; I'll spend a moment on that data coming up.
我們在 12 月份展示了該數據;我將花一點時間討論即將出現的數據。
That also received a priority review designation from the US FDA.
該產品還獲得了美國 FDA 的優先審查指定。
We had regulatory submission acceptances for Faslodex in the US and EU in 1st-line breast cancer.
我們在美國和歐盟已獲得 Faslodex 用於一線乳腺癌治療的監管提交。
In CVMD, we had the DURATION-7 trial that Pascal -- it met its primary endpoint showing glucose lowering.
在 CVMD 中,我們進行了 Pascal 的 DURATION-7 試驗,它達到了顯示血糖降低的主要終點。
In this case, that is Bydureon plus basal insulin versus basal insulin alone, and showing a reduction in hemoglobin A1C.
在本例中,即 Bydureon 加基礎胰島素與單獨使用基礎胰島素的對比,顯示血紅蛋白 A1C 降低。
That follows on to the positive DURATION-8 data that we shared earlier in the year.
這是我們今年早些時候分享的積極的 DURATION-8 數據的延續。
The publication of that came out in The Lancet in December and that showed the effects of Bydureon plus Farxiga similarly on hemoglobin A1C lowering.
該論文於 12 月發表在《柳葉刀》上,表明 Bydureon 聯合 Farxiga 對降低血紅蛋白 A1C 具有類似的作用。
Also, if you look at that publication, some interesting impact on bodyweight and decreased bodyweight.
另外,如果您查看該出版物,您會發現對體重和體重下降有一些有趣的影響。
FibroGen initiated the rolling regulatory submission for our anemia medicine, roxadustat in China.
FibroGen 啟動了我們的貧血藥物 roxadustat 在中國的滾動監管申請。
In the respiratory portfolio, Symbicort was approved in younger patients, those between 12 and 18 years of age.
在呼吸系統產品組合中,Symbicort 被批准用於 12 至 18 歲的年輕患者。
As has been mentioned, benralizumab, our second BLA, the submission was accepted in the United States and in the EU for severe uncontrolled asthma.
如前所述,貝那利珠單抗是我們的第二個 BLA,該申請已在美國和歐盟被接受,用於治療嚴重的不受控制的哮喘。
The alliance with Lilly in Alzheimer's disease was expanded beyond our current phase III collaboration at the base inhibitor, to include an amyloid beta monoclonal antibody.
與禮來公司在阿爾茨海默氏病方面的聯盟擴大到我們目前在基礎抑製劑方面的 III 期合作,其中包括澱粉樣蛋白 β 單克隆抗體。
Now, if we can go on to slide 29, please.
現在,請繼續看幻燈片 29。
We have also, in recent times with all of this data, been highly visible at conferences and congresses.
最近,我們還利用所有這些數據在會議和代表大會上引起了高度關注。
We're highlighting some of those here.
我們在這裡重點介紹其中的一些。
At the American Society of Hematology, acalabrutinib data was shared from Acerta in two interesting patient populations; patients with CLL, who are ibrutinib intolerant and also those who have a Richter's transformation, whose CLL turns into aggressive lymphoma.
在美國血液學會,Acerta 分享了 acalabrutinib 在兩個有趣的患者群體中的數據;對依魯替尼不耐受的 CLL 患者以及患有里氏轉化(其 CLL 轉變為侵襲性淋巴瘤)的患者。
At the San Antonio Breast Cancer Symposium, we shared the data from the FALCON trial, Faslodex, in the 1st-line setting in breast cancer.
在聖安東尼奧乳腺癌研討會上,我們分享了 FALCON 試驗 Faslodex 在乳腺癌第一線治療中的數據。
This also enabled the filings that I mentioned.
這也啟用了我提到的文件。
Then at the World Conference on lung cancer, we shared the durvalumab data from the ATLANTIC trial.
然後在世界肺癌大會上,我們分享了 ATLANTIC 試驗的 durvalumab 數據。
Then also highlighted Tagrisso's AURA3 data in 2nd-line EGFR-mutated lung cancer with the T790M resistance mutation after having received the first generation EGFR inhibitors.
然後還重點介紹了 Tagrisso 在接受第一代 EGFR 抑製劑治療後出現 T790M 耐藥突變的二線 EGFR 突變肺癌中的 AURA3 數據。
Let's go to slide 30, please.
請看幻燈片 30。
This is that data and it's, I think, very exciting and quite extraordinary.
我認為這就是這些數據,非常令人興奮且非同尋常。
What we have here is Kaplan Meier curve, progression-free survival.
我們這裡有的是卡普蘭邁耶曲線,即無進展生存期。
You'll see here that median progression-free survival here was 10.1 months with Tagrisso versus 4.4 months with chemotherapy, which is the current standard of care for EGFR-mutated patients who progress after an EGFR inhibitor.
您將在此處看到,使用Tagrisso 的中位無進展生存期為10.1 個月,而使用化療的中位無進展生存期為4.4 個月,這是使用EGFR 抑製劑後病情進展的EGFR 突變患者的當前護理標準。
The hazard ratio here is quite remarkable at 0.3, and obviously statistically significant as well.
這裡的風險比非常顯著,為 0.3,並且在統計上也明顯顯著。
The other thing I think that's fascinating about Tagrisso and was shared there is we did not exclude CNS patients from this trial.
我認為 Tagrisso 令人著迷並在那里分享的另一件事是我們沒有將中樞神經系統患者排除在這項試驗之外。
About 34% of patients had CNS disease brain metastases on entry to the trial.
大約 34% 的患者在進入試驗時患有中樞神經系統疾病腦轉移。
Interestingly, their progression -- that's usually a poor prognostic factor, I should add -- their progression-free survival hazard ratio was 0.32, very comparable to the patient population as a whole.
有趣的是,他們的進展(我應該補充一下,這通常是一個不良的預後因素)他們的無進展生存風險比為 0.32,與整個患者群體非常相似。
And this property of Tagrisso to be able to penetrate the blood-brain barrier, which by the way the first generation EGFR inhibitors are not able to do, is continuing to be studied in the ongoing BLOOM trial.
Tagrisso 的這種特性能夠穿透血腦屏障,而第一代 EGFR 抑製劑無法做到這一點,這一特性正在正在進行的 BLOOM 試驗中繼續進行研究。
Let's go on to slide 31, please.
請繼續看幻燈片 31。
Moving on to a topic that I think is probably near and dear to all your hearts, which is the immune-oncology portfolio.
現在轉到我認為可能與你們所有人都很親近的話題,那就是免疫腫瘤學組合。
This is an overview of our lung cancer program, both ongoing program you will know quite a bit about and some recent changes and additions we've made.
這是我們肺癌項目的概述,包括您對正在進行的項目以及我們最近所做的一些更改和補充的了解。
Obviously, we have multiple trials in earlier-line lung cancer.
顯然,我們對早期肺癌進行了多項試驗。
This remains an unmet need, a terrible disease and a reasonably common cancer.
這仍然是一個未滿足的需求,是一種可怕的疾病和相當常見的癌症。
The PACIFIC and the MYSTIC trials are fully recruited.
PACIFIC 和 MYSTIC 試驗已全部招募完畢。
And, as we've communicated, we expect top-line results for progression-free survival this year.
而且,正如我們所傳達的,我們預計今年將獲得無進展生存期的最高結果。
We've also communicated that the MYSTIC trial analysis plan was updated.
我們還通報了 MYSTIC 試驗分析計劃已更新。
As many of you will know, when initially started, MYSTIC was designed with progression-free survival as the only primary endpoint.
正如你們許多人所知,MYSTIC 最初設計時將無進展生存期作為唯一的主要終點。
Last year, around this time, we changed the trial to elevate overall survival to a co-primary endpoint.
去年的這個時候,我們改變了試驗,將總體生存率提高到共同主要終點。
And that was done because emerging evidence indicates that overall survival better captures the benefit given to patients by immunotherapy for cancer.
這樣做是因為新出現的證據表明,總體生存率更好地體現了癌症免疫療法給患者帶來的益處。
In order to do that and maintain the power of the trial, we increased the size of the trial from 700 to about 1,100 patients and we were able to, nonetheless with that increase, enroll quite quickly.
為了做到這一點並保持試驗的有效性,我們將試驗規模從 700 名患者增加到約 1,100 名患者,儘管如此,我們還是能夠很快地入組。
And that allows us to be confident in the power of the trial to detect clinically meaningful differences in these different endpoints.
這讓我們對試驗檢測這些不同終點有臨床意義的差異的能力充滿信心。
So MYSTIC will now assess progression-free survival and overall survival in patients with PD-L1 expressing tumors, with the opportunity to then look at both durvalumab monotherapy and durvalumab/tremelimumab combination therapy.
因此,MYSTIC 現在將評估表達 PD-L1 的腫瘤患者的無進展生存期和總生存期,然後有機會研究 durvalumab 單藥療法和 durvalumab/tremelimumab 聯合療法。
And then it will also look as well in all-comers for the combination of durva plus treme, recognizing that in the low expressers of PD-L1, the monotherapy has limited activity.
然後,它還將在所有患者中尋找 durva 加 treme 的組合,認識到在 PD-L1 低表達者中,單一療法的活性有限。
And this is, of course, versus the standard of care chemotherapy.
當然,這是與標準化療相比的。
So this trial can stand on its own as a registrational trial for full approval in the 1st-line.
因此,該試驗可以獨立作為註冊試驗,在第一線獲得完全批准。
The progression-free survival, as many will know, will be available in mid-2017 with the final overall survival data coming, at the latest, next year.
正如許多人所知,無進展生存期將於 2017 年中期公佈,最終的總生存期數據最遲將於明年公佈。
We have been asked about interim analysis.
我們被問及中期分析。
We do have interim analysis in the trial.
我們確實在試驗中進行了中期分析。
We don't disclose the detail of those but those are for overall survival.
我們不會透露這些細節,但這些都是為了整體生存。
Another change we made was to NEPTUNE.
我們所做的另一個改變是 NEPTUNE。
NEPTUNE is durva plus treme versus standard of care chemotherapy.
NEPTUNE 是 durva 加 treme 與標準護理化療的比較。
We expanded with local patients in China to get more experience in China with the durva/treme combo.
我們擴大了與中國當地患者的合作,以獲得更多在中國使用 durva/treme 組合的經驗。
That expansion will not delay the availability of the survival data in 2018 at the latest for the global portion of the trial.
此次擴展不會延遲該試驗全球部分最晚在 2018 年提供生存數據。
And then we started an additional trial in Asia, a phase III trial called PEARL.
然後我們在亞洲開始了一項額外的試驗,一項名為 PEARL 的 III 期試驗。
PEARL is a durvalumab monotherapy trial versus, again, standard of care chemotherapy and this in PD-L1 expressing non-small cell lung cancer.
PEARL 是一項 durvalumab 單一療法對比標準護理化療的試驗,試驗對像是表達 PD-L1 的非小細胞肺癌。
So what we've done with this is we've really enhanced our options and followed the scientific data, both for our primary strategy, which was the durva/treme combination, and the durva/treme combination particularly in lower non-expressers of PD-L1, but also enhanced options in the more established therapeutic hypothesis, which is durvalumab or PD-L1 monotherapy in PD-L1 expressing tumors.
因此,我們所做的是,我們確實增強了我們的選擇並遵循了科學數據,無論是對於我們的主要策略,即durva/treme 組合,還是durva/treme 組合,特別是在PD 的低非表達者中-L1,而且還增強了更成熟的治療假設的選擇,即表達 PD-L1 的腫瘤中的 durvalumab 或 PD-L1 單藥療法。
Can we then go on to slide 32?
我們可以繼續看幻燈片 32 嗎?
So this, again, is the data readout slide for the IO program, not just in lung cancer, lung cancer is at the bottom, but across bladder cancer and head and neck cancer as well.
所以,這又是 IO 程序的數據讀出幻燈片,不僅是肺癌,肺癌位於底部,而且還包括膀胱癌和頭頸癌。
So clearly, we have a busy year/18 months going on here.
很明顯,我們將度過忙碌的一年/18 個月。
We expect ARCTIC data in the first half of 2017; MYSTIC PFS data, as I mentioned, midyear; PACIFIC in the second half of this year; head and neck results from KESTREL in the second half of the year.
我們預計北極數據將於 2017 年上半年公佈;正如我提到的,年中的 MYSTIC PFS 數據;今年下半年的太平洋; KESTREL 將於今年下半年取得頭頸部結果。
KESTREL, again, is the 1st-line head and neck and cancer.
KESTREL 再次成為頭頸癌的一線治療藥物。
And then 1st-line bladder cancer, DANUBE, and 2nd-line head and neck cancer, EAGLE come later in 2018.
然後,一線膀胱癌 DANUBE 和二線頭頸癌 EAGLE 將於 2018 年晚些時候上市。
And then as I mentioned just a moment ago, NEPTUNE in 1st-line lung cancer with the durva/treme combo in 2018.
正如我剛才提到的,2018 年 NEPTUNE 與 durva/treme 組合用於一線肺癌治療。
Next slide, please.
請下一張幻燈片。
This lists, across the portfolio, the late-stage pipeline news flow we expect this year and going into next year.
這列出了整個投資組合中我們預計今年和明年的後期管道新聞流。
Obviously, we have quite an abundance of regulatory decisions, regulatory submissions and key data readouts that we are expecting in this time.
顯然,我們這次有大量的監管決策、監管提交和關鍵數據讀數。
To highlight some of them; as I said, we expect the regulatory decision on durvalumab in bladder cancer by end of Q2 this year.
突出其中一些;正如我所說,我們預計今年第二季度末將對 durvalumab 治療膀胱癌的監管決定做出。
For Tagrisso, we expect data readout, based on FLAURA, in the second half of 2017.
對於 Tagrisso,我們預計基於 FLAURA 的數據將於 2017 年下半年讀出。
FLAURA would move Tagrisso into the 1st-line EGFR-mutated population, and that's versus Iressa, the existing standard of care.
FLAURA 將使 Tagrisso 進入一線 EGFR 突變人群,這與現有的治療標準易瑞沙相比。
The number of regulatory submissions here is extraordinary, so there is a lot of excitement around this and a lot of work to be done.
這裡提交的監管申請數量非常多,因此對此有很多令人興奮的事情,並且還有很多工作要做。
In 2017, we anticipate, data permitting, immuno-oncology submissions in lung cancer.
在數據允許的情況下,我們預計 2017 年將提交肺癌免疫腫瘤學研究報告。
And, again as I said, the 1st-line data for Tagrisso based on FLAURA; submissions for Lynparza in ovarian cancer, based on the SOLO-2 data; and as well, depending upon the readout from OlympiAD in breast cancer.
而且,正如我所說,Tagrisso 的第一線數據基於 FLAURA;基於 SOLO-2 數據提交的 Lynparza 治療卵巢癌的資料;同樣,取決於乳腺癌中 OlympiAD 的讀數。
We have the potential for a fast to market submission in the blood cancer for acalabrutinib.
我們有潛力將 acalabrutinib 的血癌藥物快速推向市場。
With regarding to Lynparza and that SOLO-2 data, we've done a top-line announcement that the trial was positive.
關於 Lynparza 和 SOLO-2 數據,我們已經發布了一項重要聲明,表明該試驗是積極的。
We are going to present that data for everyone to look at the details at the Society of Gynecologic Oncology, which is an annual meeting on women's cancers, and that will be in March of this year.
我們將向大家展示這些數據,以便在婦科腫瘤學會上查看詳細信息,這是一次關於女性癌症的年度會議,將於今年 3 月舉行。
We are really looking forward to being able to share that with you because I know you have questions about PARP inhibition and about where does Lynparza fit in.
我們真的很期待能夠與您分享這一點,因為我知道您對 PARP 抑制以及 Lynparza 的作用有疑問。
And I think that being able to talk about the data in detail is going to help clarify that.
我認為能夠詳細討論數據將有助於澄清這一點。
And in the other key therapeutic areas in CVMD, we expect the Bydureon auto-injector submission in the first half of this year.
在 CVMD 的其他關鍵治療領域,我們預計 Bydureon 自動注射器將於今年上半年提交。
And with benralizumab, we expect the US regulatory decision, based on the submission that we already talked about in the second half of this year for severe uncontrolled asthma.
對於貝那利珠單抗,我們預計美國監管機構會根據今年下半年我們已經討論過的嚴重不受控制哮喘的提交材料做出決定。
It's busy and it's an exciting time for us, and we are confident that we have the right trials, the right trial designs and excellent drugs to make a difference to patients and to continue to grow the new AstraZeneca.
這對我們來說很忙碌,也是一個激動人心的時刻,我們相信我們擁有正確的試驗、正確的試驗設計和優秀的藥物,可以為患者帶來改變,並繼續發展新的阿斯利康。
And with that, I will hand back to Pascal for closing remarks.
接下來,我將請帕斯卡發表閉幕詞。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thank you, Sean.
謝謝你,肖恩。
Let me just say a few words of conclusion before we open for Q&A, so if I can have the last slide.
在我們開始問答之前,讓我先說幾句話,以便我可以看最後一張幻燈片。
The messages I want to leave you with today are; number one, our financials are on track and we met our guidance for the year.
今天我想留給你們的信息是:第一,我們的財務狀況步入正軌,並且達到了今年的指導目標。
Number two, we have 12 new potential medicines in phase III and under registration, so a very, very strong pipeline that is starting to deliver.
第二,我們有 12 種新的潛在藥物處於 III 期並正在註冊中,因此一個非常非常強大的管道正在開始交付。
Importantly, beyond the pipeline, we also have tremendous commercial organizations around the world, and in particular in the emerging markets, we have a business that has been steadily growing.
重要的是,除了渠道之外,我們還在世界各地擁有龐大的商業組織,特別是在新興市場,我們的業務一直在穩步增長。
We have delivered a consistent mid to high single-digit growth rate; in fact, sometimes double-digit growth rate overall.
我們實現了持續的中高個位數增長率;事實上,有時整體增長率會達到兩位數。
And in China, in particular, we have consistently delivered double-digit growth rate and outpaced the market growth rate.
尤其是在中國,我們一直保持兩位數的增長率,並超過了市場增長率。
We've made faster progress in oncology, for obvious reasons.
出於顯而易見的原因,我們在腫瘤學方面取得了更快的進展。
We have, of course, great medicines but also, as you all know, you can develop products in oncology faster than in some other therapy areas.
當然,我們擁有出色的藥物,但眾所周知,您可以比其他一些治療領域更快地開發腫瘤學產品。
Tagrisso has been a great launch so far and it's continuing to do very well and we have great data to support further growth this year.
迄今為止,Tagrisso 的推出非常出色,並且繼續表現出色,我們有大量數據支持今年的進一步增長。
The immuno-oncology programs, of course, are making progress and this year is going to be an important year for our immuno-oncology portfolio.
當然,免疫腫瘤學項目正在取得進展,今年將是我們免疫腫瘤學產品組合的重要一年。
And over the next 12 months we have a very busy news flow.
在接下來的 12 個月裡,我們的新聞流非常繁忙。
So at the end of the day, net net is we're really getting to an inflection point here as we end this patent cliff, which often has been a little bit exhausting for our teams around the world.
因此,歸根結底,當我們結束這個專利懸崖時,我們真的到達了一個拐點,這常常讓我們世界各地的團隊有點疲憊。
We're getting to the end of that patent cliff, the pipeline is starting to deliver, and we see the new AstraZeneca emerge.
我們正在接近專利懸崖的盡頭,管道開始交付,我們看到新的阿斯利康出現。
So we have another 1 or 1.5 years of managing the end of this patent cliff and launching these new products.
因此,我們還有 1 到 1.5 年的時間來應對這一專利懸崖的結束並推出這些新產品。
And in many ways, the R&D organization, as I said a minute ago, has done a fantastic job, and now they are passing the baton to the commercial organization around the world, who have been playing defense in many respects; there a few defending very successfully our old products.
在很多方面,正如我剛才所說,研發組織做得非常出色,現在他們將接力棒交給了世界各地的商業組織,而商業組織在很多方面都在防守;有一些非常成功地捍衛了我們的舊產品。
Re-tooling, building capabilities in diabetes, in respiratory decease, we're building that.
我們正在重組工具,建設糖尿病和呼吸系統疾病方面的能力。
Importantly, building capabilities in oncology, refocusing ourselves, re-launching Brilinta, trying to grow our diabetes business and doing this is in the context of a declining SG&A as we are managing our declining top line.
重要的是,建設腫瘤學能力、重新調整自己的注意力、重新推出 Brilinta、努力發展我們的糖尿病業務,而這樣做是在 SG&A 下降的背景下進行的,因為我們正在管理不斷下降的營收。
And now, they are redeploying themselves to preparing the new launches, and I have no doubt they're going to do a great job.
現在,他們正在重新部署自己,準備新產品的發布,我毫不懷疑他們會做得很好。
They've started doing a great job already with Tagrisso, and other products, and there's a lot more coming for them.
他們已經開始在 Tagrisso 和其他產品上取得出色的成績,並且還有更多的產品等著他們。
So the next 12 to 18 months suddenly are going to become suddenly quite exciting for the commercial organization, as you can imagine; launching new products is certainly more energizing than playing defense, as we have been doing for a period of time.
因此,接下來的 12 到 18 個月對於商業組織來說將突然變得非常令人興奮,正如你可以想像的那樣;推出新產品肯定比防守更有活力,正如我們一段時間以來所做的那樣。
So with this, I'll stop here and open the floor for questions.
因此,我將在此停止並開始提問。
Matthew Weston - Analyst
Matthew Weston - Analyst
Matthew Weston, Credit Suisse.
馬修·韋斯頓,瑞士信貸。
Can I ask three, please?
請問可以問三個嗎?
The first on durva/treme and MYSTIC, Sean, it's fitting that we start there.
關於 durva/treme 和 MYSTIC 的第一個,Sean,我們從這裡開始是合適的。
There's been a lot of debate, since you changed the endpoints, as to whether or not the combination arm needs to show superiority to durva mono in order for the trial to be fileable.
自從你改變了終點以來,關於聯合用藥是否需要表現出優於 durva mono 才能使試驗可提交的問題,存在很多爭論。
I think we'd all just love your views on that in terms of how you see the filing strategy and absolutely what's necessary.
我想我們都會喜歡您對此的看法,包括您如何看待申請策略以及絕對必要的內容。
Secondly, Marc, on the numbers.
其次,馬克,關於數字。
You gave us a trend for what we should expect for R&D over the course of 2017, but you didn't really give us clarity on SG&A.
您向我們提供了 2017 年研發預期的趨勢,但您並沒有真正向我們說明 SG&A 的情況。
If you could give us some indication as to where those levels are going to settle down, the incremental savings possible in 2017, I think that would be very helpful.
如果您能給我們一些關於這些水平將穩定在什麼位置的指示,即 2017 年可能實現的增量節省,我認為這將非常有幫助。
And then, Pascal, a big picture question; I think you set out the pipeline, all the extremely exciting opportunities at the Company, but clearly what we have seen in recent months is that a number of members of the executive team have been attracted away from the Company.
然後,帕斯卡,一個大局問題;我認為你列出了公司的管道,所有極其令人興奮的機會,但顯然我們最近幾個月看到的是,管理團隊的一些成員已被吸引離開公司。
So I would very much welcome your views as to why that is, and whether that impacts your ability to deliver commercially and on the pipeline going into 2017 and in the midterm?
因此,我非常歡迎您就其原因發表意見,以及這是否會影響您在 2017 年和中期的商業交付和管道交付的能力?
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
So shall we start with the d+t question, Sean?
那麼我們可以從 d+t 問題開始嗎,肖恩?
Go ahead.
前進。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Thank you for the question.
感謝你的提問。
For the trial to be positive, durva mono or durva/treme combo has to beat standard of care chemotherapy, and that will enable filing.
為了使試驗取得積極的結果,durva mono 或 durva/treme 組合必須擊敗標準護理化療,這樣才能進行備案。
The question of durva mono versus the combo is a little more nuanced in that it will be a benefit risk assessment.
durva 單藥與組合的問題更加微妙,因為它將是一個效益風險評估。
So we are quite confident, based on data, that there will be more toxicity of the combination, in particular auto-immune toxicities coming with IO.
因此,根據數據,我們非常有信心該組合會產生更多毒性,特別是 IO 帶來的自身免疫毒性。
And so it will have to have the benefit above durva mono in order for the combo to be fileable, and that benefit would have to offset, in our assessment, the assessment of regulators, any toxicity that's seen, so it will be data dependent in that way.
因此,它必須具有高於 durva mono 的益處,以便該組合可以歸檔,並且在我們的評估中,該益處必須抵消監管機構的評估以及所看到的任何毒性,因此它將依賴於數據那樣。
It does not have to be beat durva mono for durva mono to be fileable.
不必擊敗 durva mono 即可歸檔。
I talked a little bit about it before, our original hypothesis was that what durva/treme combo would bring us is an opportunity to bring IO therapy to patients who weren't benefiting from it, that being PD-L1 low and non-expressers.
我之前談過一點,我們最初的假設是 durva/treme 組合將為我們帶來一個機會,將 IO 療法帶給那些沒有從中受益的患者,即 PD-L1 低和非表達者。
I think, as data has emerged in the field, the question of whether durva/treme combo might also bring benefit to PD-L1 high expressers is a question that is out there.
我認為,隨著該領域數據的出現,durva/treme 組合是否也可能為 PD-L1 高表達者帶來益處是一個存在的問題。
And so we've enabled the trial to look at those populations and we'll have to wait and see what the data says.
因此,我們已經啟動了試驗來觀察這些人群,我們將不得不等待,看看數據說明了什麼。
Does that answer your question?
這是否回答你的問題?
Marc Dunoyer - CFO
Marc Dunoyer - CFO
Just to comment on the question on SG&A for 2017.
只是評論一下關於 2017 年 SG&A 的問題。
When we were one year ago in 2016, early 2016, we indicated a material reduction on this SG&A line and we, in fact, delivered 9%.
一年前的 2016 年,即 2016 年初,我們表示該 SG&A 項目大幅削減,事實上,我們交付了 9%。
So I would say we delivered probably a bit more than what we had expected.
所以我想說,我們交付的成果可能比我們的預期要多一些。
We are continuing our effort on SG&A cost reduction and you can anticipate another reduction in 2017.
我們正在繼續努力降低 SG&A 成本,預計 2017 年將再次降低。
I'm not going to quantify the reduction, but it's going to be another reduction for the year.
我不會量化減少的數量,但這將是今年的另一次減少。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Okay, Matt, thanks for the last question.
好的,馬特,謝謝你最後一個問題。
Let me just cover this question about talent movement.
我簡單講一下人才流動的問題。
First of all, I don't know how far you go when you say over the last few months, in the recent few months two of our senior leaders have moved on and I have to say, they've moved to fantastic jobs, both of them.
首先,我不知道你在過去幾個月裡說得有多遠,在最近幾個月裡,我們的兩位高級領導已經離職,我不得不說,他們都轉到了很棒的工作崗位上。其中。
And it makes me very proud that they actually could get such great jobs, and it's a reflection, in many ways, that we have a very deep talent bench at AstraZeneca and we have people who are able to take those jobs.
這讓我感到非常自豪,他們實際上能夠獲得如此出色的工作,這在很多方面都反映出我們在阿斯利康擁有非常深厚的人才庫,並且我們有能夠接受這些工作的人。
I know that some people have said, well, do they know something that we don't know, does it mean the pipeline is not working out?
我知道有些人說過,好吧,他們是否知道一些我們不知道的事情,這是否意味著管道無法正常工作?
I know some of you will be at the breakfast meeting tomorrow that we've organized.
我知道你們中的一些人將參加我們明天組織的早餐會。
And Mondher in particular we'll be there, so it's a kind of farewell party for him.
尤其是蒙德,我們會在那裡,所以這對他來說是一種告別派對。
Mondher has been a great friend of mine for the last 15 years.
過去 15 年來,Mondher 一直是我的好朋友。
Actually, he's recruited by the person who recommended him to me 15 years ago, so it's kind of almost a family affair.
事實上,他是 15 年前向我推薦他的人招募的,所以這幾乎是一個家庭事務。
You can ask him questions about what he believes of the pipeline.
你可以問他對管道的看法。
But net net is they've been really able to grow, so that's one thing I would say.
但他們確實能夠成長,所以這是我想說的一件事。
The second is, we have a very deep talent pool at AstraZeneca and we have other people who will grow and take advantage of these opportunities.
第二是,我們在阿斯利康擁有非常深厚的人才庫,我們還有其他人將成長並利用這些機會。
Jamie Freedman, who is replacing Mondher and you will meet him tomorrow, was at Medi for the last four years/five years, before that at Merck and GSK.
傑米·弗里德曼(Jamie Freedman) 將接替蒙德,明天您將與他見面,他過去四年/五年都在Medi 工作,此前曾在默克(Merck) 和葛蘭素史克(GSK ) 工作。
He's an incredibly talented oncologist, who has already started making a big impact on our oncology business.
他是一位非常有才華的腫瘤學家,已經開始對我們的腫瘤學業務產生重大影響。
This is a good example of someone who emerges out of our organization.
這是從我們組織中脫穎而出的一個很好的例子。
And maybe the last point I would make is that you really have to look at the people who leave and the people who come.
也許我要說的最後一點是,你真的必須看看那些離開的人和來的人。
So if you look at the people who've left over the last few months, you also have to look at the people who've joined us over the last few months.
因此,如果你看看過去幾個月裡離開的人,你也必須看看過去幾個月裡加入我們的人。
The first one is sitting there, our CMO, and he's made a tremendous impact on our oncology business and our pipeline overall.
第一位是我們的首席營銷官,他對我們的腫瘤業務和整個管道產生了巨大的影響。
And so it's really been really great to have Sean join us.
肖恩加入我們真是太好了。
Some of you have met David Berman at Medimmune, fantastic scientist leading our oncology business at Medimmune, and many others at Medimmune and AstraZeneca across the board.
你們中的一些人見過 Medimmune 的 David Berman,他是領導 Medimmune 腫瘤學業務的傑出科學家,還有 Medimmune 和阿斯利康的許多其他人。
So for me, it is actually part of the industry, it's part of the business we are in.
所以對我來說,它實際上是行業的一部分,是我們所處業務的一部分。
People come, they grow; hopefully, you can offer them opportunities within AstraZeneca, within your company.
人來了,人就成長;希望您可以在阿斯利康、您的公司內為他們提供機會。
Sometimes someone else comes along and offer them a job that we're not able to offer them because that's structurally an option we don't have.
有時,其他人會向他們提供我們無法提供的工作,因為從結構上講,我們沒有這種選擇。
And it's really certainly very pleasing to see some of our peers in the industry feel the need to come and recruit some of our talent for jobs they have to fill.
看到我們的一些業內同行感到有必要來招聘我們的一些人才來填補他們必須填補的職位,這確實是非常令人高興的。
So that's what I would say about this.
這就是我要說的。
But, ask Mondher tomorrow what he thinks of the pipeline and whether he's lost confidence in it or not.
但是,明天問問蒙德爾他對這條管道的看法以及他是否對此失去了信心。
Sachin Jain - Analyst
Sachin Jain - Analyst
Sachin Jain, Bank Of America.
薩欽·賈恩 (Sachin Jain),美國銀行。
A few questions, please.
請教幾個問題。
So firstly, for Marc, you haven't given product sales guidance but I guess it's implied lower than consensus, given the higher one-off expectations versus consensus.
首先,對於馬克來說,你還沒有給出產品銷售指導,但我想這意味著低於共識,因為一次性預期比共識更高。
Just two related questions; any color on how you're thinking about product sales growth for 2017?
只有兩個相關的問題;您對 2017 年產品銷售增長有何看法?
And I guess, more importantly, how much of the delta versus consensus is a weaker base business versus lost sales that you're externalizing?
我想,更重要的是,與共識相比,增量中有多少是基礎業務較弱與您外部化的銷售損失?
Second question, still on the one-offs; you've commented on one-offs for this year being in the same level to 2016, which was $3.5 billion, so $3.5 billion and $3.5 billion is getting it to $7 billion.
第二個問題,還是一次性的;您曾評論過今年的一次性支出與 2016 年的水平相同,即 35 億美元,因此 35 億美元和 35 億美元將使其達到 70 億美元。
If I remember rightly, the discussion at this time last year was roughly $2 billion for both years, which are obviously substantially higher.
如果我沒記錯的話,去年這個時候的討論金額兩年約為 20 億美元,顯然要高得多。
Is that front loading of what you'd planned over the midterm or do we expect this high level to continue?
這是您在中期計劃中提前加載的內容還是我們預計這種高水平會持續下去?
And then the final question is for Sean, on MYSTIC.
最後一個問題是關於 MYSTIC 的 Sean。
I'm not sure you're expecting this issue; I think Pascal referenced in his introductory comments confidence in the combination, despite external factors.
我不確定你是否期待這個問題;我認為帕斯卡在他的介紹性評論中提到了對組合的信心,儘管有外部因素。
I wonder if you could address what we've seen from Bristol more directly and your perspectives on delay to filing and their less than effusive commentary on the combination in 1st-line?
我想知道您是否可以更直接地談談我們從布里斯托爾看到的情況以及您對延遲申請的看法以及他們對第一線合併的不那麼熱情的評論?
And I guess the background to this is you have a lot more data from phase I than we've seen from 006, so is there any chance of us seeing 006 prior to MYSTIC?
我猜這背後的背景是,第一階段的數據比我們從 006 中看到的要多得多,那麼我們有可能在 MYSTIC 之前看到 006 嗎?
Thanks.
謝謝。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Sachin.
謝謝,薩欽。
Before Marc and Sean address your questions, let me just say, a bit earlier when I said we were confident, we run the studies because we don't know the answer.
在馬克和肖恩回答你的問題之前,讓我先說一下,早些時候我說我們有信心,我們進行研究是因為我們不知道答案。
Of course, we run MYSTIC to have the answer to whether a combination works better than monotherapy.
當然,我們運行 MYSTIC 是為了找到聯合療法是否比單一療法效果更好的答案。
So I'm not confident to the extent I know what the results of MYSTIC will be.
所以我對 MYSTIC 的結果並沒有信心。
What I meant to say is that there's nothing new that we have seen that will change our level of confidence and, in fact, our data are not really changing any of our previous views, and Sean will cover this.
我的意思是說,我們沒有看到任何新的東西會改變我們的信心水平,事實上,我們的數據並沒有真正改變我們之前的任何觀點,肖恩將涵蓋這一點。
But the BMS development is, to a great extent, something we were expecting, for reasons Sean will be explaining in a minute.
但 BMS 的開發在很大程度上是我們所期待的,肖恩稍後將解釋原因。
But maybe we should start with the financial questions, Marc.
但也許我們應該從財務問題開始,馬克。
Marc Dunoyer - CFO
Marc Dunoyer - CFO
First of all, on the guidance for product sales we do not provide guidance for product sales, but we do provide a guidance on the total revenues and have explained this to you earlier on.
首先,關於產品銷售的指導,我們不提供產品銷售的指導,但是我們提供了總收入的指導,之前已經向大家解釋過。
Regarding your second question, which is part of the total revenue because it contains externalization revenue, the guidance I gave one year ago were that it would be an increase of externalization revenue and other income versus the level of 2015.
關於你的第二個問題,它是總收入的一部分,因為它包含外部化收入,我一年前給出的指導是,與2015年的水平相比,外部化收入和其他收入將有所增加。
And the total of externalization revenue and other income in 2015 was $2.5 billion.
2015年外部化收入和其他收入總額為25億美元。
So I do not remember giving you guidance for two years in a row at $2 billion.
所以我不記得連續兩年給你提供了 20 億美元的指導。
If I did, I would have misspoken but if you could look at it.
如果我這樣做的話,我就會說錯了,但如果你能看一下的話。
So what I can confirm today that we have given you a trend for an increase of externalization revenue and other income for 2016 and you have now quoted the number, $3.4 billion, $3.5 billion, we are going to have a greater amount in the year 2017.
所以我今天可以確認的是,我們已經向您提供了2016 年外部化收入和其他收入增長的趨勢,您現在已經引用了這個數字,34 億美元、35 億美元,我們在2017 年將會有更多的金額。
So greater than $3.4 billion, $3.5 billion.
超過 34 億美元、35 億美元。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Marc.
謝謝,馬克。
Sean, do you want to cover the other question?
肖恩,你想回答另一個問題嗎?
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Yes, Sachin, thanks for the questions.
是的,薩欽,謝謝你的提問。
I'm going to start with the BMS combo question and if we read through to MYSTIC and the durva/treme combo.
我將從 BMS 組合問題開始,如果我們通讀 MYSTIC 和 durva/treme 組合。
We were asked, and I talked to some of you around Q3, about BMS's announcement around this approach and at that time, prior to hearing anything else, we said we thought it was a very low probability of regulatory success.
我們被問到,並且我在第三季度左右與你們中的一些人討論了 BMS 圍繞這種方法的公告,當時,在聽到其他消息之前,我們說我們認為監管成功的可能性非常低。
And the reasons that we felt that was, when you file on a single arm trial you really have to demonstrate an extraordinary treatment effect, over the standard of care.
我們認為的原因是,當您提交單臂試驗時,您確實必須證明超出護理標準的非凡治療效果。
Now, if the standard of care is really ineffective, then not much data can actually indicate you have more activity.
現在,如果護理標準確實無效,那麼實際上沒有多少數據可以表明您有更多的活動。
But when you move into the 1st-line of non-small cell lung cancer the standard of care is doublet chemotherapy, which has a demonstrated PFS and LS benefit.
但當您進入非小細胞肺癌的第一線治療時,標準護理是雙重化療,它具有已證實的 PFS 和 LS 益處。
Doesn't cure the disease, it's still an unmet need.
不能治癒疾病,它仍然是一個未滿足的需求。
But to get single arm data that gives regulators confidence that they should put your medicine out there is a big bar, so that's why we thought that.
但要獲得單臂數據,讓監管機構有信心將你的藥物投放市場,這是一個很大的障礙,所以這就是我們這麼認為的原因。
The other reason we thought that is, we've discussed many, many times, we believe that overall response rate, which is primarily the data you will have, underestimates the treatment benefit of IO therapy and, of course, IOIO and so, again, that's primarily what you'd been relying on.
我們認為的另一個原因是,我們已經討論過很多次了,我們相信總體緩解率(主要是您將獲得的數據)低估了 IO 療法的治療效果,當然還有 IOIO 等等。 ,這主要是您所依賴的。
So that combination of things made us, at that time, believe it was unlikely.
因此,這些因素的結合讓我們當時認為這不太可能。
Now we've heard it's not happening, it doesn't change anything for us in terms of that.
現在我們聽說它沒有發生,這對我們來說沒有任何改變。
Again, I want to reiterate what Pascal said, if we knew the outcome of MYSTIC we wouldn't have to do it.
我想再次重申 Pascal 所說的,如果我們知道 MYSTIC 的結果,我們就不必這樣做。
But what we're confident in is the power, the design, the analysis plan and as the field has moved, we've incorporated what is known as well as we possibly can into that plan.
但我們對動力、設計、分析計劃充滿信心,隨著該領域的發展,我們已盡可能地將已知的內容納入該計劃中。
006, prior to MYSTIC; we did expand 006, we expanded 006 with 2nd-line patients.
006,在神秘之前;我們確實擴展了006,我們用二線患者擴展了006。
We added some 1st-line patients; 006 enrolment of that expansion was completed late last year.
我們增加了一些一線患者; 006 擴招已於去年底完成。
So we do what all companies do which is, as a deadline for a submission for an abstract comes up, since a non-blinded study, we take a look at it and we ask is it mature enough to be a meaningful presentation.
因此,我們做了所有公司都會做的事情,即隨著提交摘要的截止日期的到來,由於是一項非盲研究,我們會對其進行查看,並詢問它是否足夠成熟,可以成為有意義的演示文稿。
And our conclusion for 006 for AZ Cowas no, it's not mature enough to be a meaningful presentation.
我們對 AZ Cos 的 006 的結論是不,它還不夠成熟,不足以成為一個有意義的演示。
So we will look again and aim for meetings later in the year to see if we're ready to present.
因此,我們將再次審視併計劃在今年晚些時候召開會議,看看我們是否準備好進行展示。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Sachin, I'm sure you will remember very well that, if you're looking for accelerated approval on the basis of a single arm study, you have to beat the standard of care not only with the median, but also the lower end of your confidence interval has to be higher than the upper band of the confidence interval of the standard of care.
Sachin,我相信您會清楚地記得,如果您正在尋求基於單臂研究的加速批准,您不僅必須在中位數上擊敗護理標準,而且還要在下限上擊敗護理標準您的置信區間必須高於護理標準置信區間的上限。
So that brings the bar very, very high.
所以這使得門檻非常非常高。
That's why we always doubted that the single arm combination study would be able to deliver an accelerated approval.
這就是為什麼我們一直懷疑單臂聯合研究能否加速批准。
It seems to have borne out as we expected, but that's all we can say at this stage.
似乎正如我們所預期的那樣,但這就是我們現階段所能說的。
Richard Parkes - Analyst
Richard Parkes - Analyst
Richard Parkes, Deutsche Bank.
理查德·帕克斯,德意志銀行。
I've just got three questions as well.
我也只有三個問題。
One just to be more specific on MYSTIC; I think people's nervousness around BMS's decision is not just on their decision not to file early, but also just their overall confidence in the approach seems to have reduced from where it was a few months ago.
一個只是為了更具體地介紹 MYSTIC;我認為人們對 BMS 決定的緊張不僅在於他們決定不提前提交申請,還在於他們對該方法的整體信心似乎比幾個月前有所下降。
So I just wondered if you could reassure investors that the response rate you're seeing from the 006 study coming through is consistent with the 35% response rate you saw from that initial cohort.
所以我只是想知道您是否可以讓投資者放心,您從 006 研究中看到的回复率與您從最初隊列中看到的 35% 的回复率一致。
That's the first question.
這是第一個問題。
Then a couple of financial ones.
然後是一些財務方面的問題。
The gross margin, I remember in the third quarter you were highlighting that you had a broadly stable gross margin, despite impact from Crestor; I think you've pretty much absorbed the full impact there, and I think the reason given was the shift towards more specialty care.
毛利率,我記得在第三季度你強調說,儘管受到 Crestor 的影響,但你的毛利率基本穩定;我認為你已經吸收了那裡的全部影響,我認為給出的原因是轉向更多的專業護理。
But now in the fourth quarter, you've had a 200 basis point negative impact; I'm just wondering what changed there.
但現在在第四季度,你已經產生了 200 個基點的負面影響;我只是想知道那裡發生了什麼變化。
And then, the final question, looking out to 2018.
然後是最後一個問題,展望 2018 年。
Given that the base in 2017, the externalization/other income is now a pretty big proportion, which I'm assuming won't be sustainable at that level, should we be thinking about a return to top-line growth in 2018, but the earnings growth not materializing until 2019?
考慮到 2017 年的基數,外部化/其他收入現在佔了相當大的比例,我認為在這個水平上這是不可持續的,我們是否應該考慮在 2018 年恢復營收增長,但盈利增長要到2019年才能實現嗎?
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Should we start with the gross margin and finance questions, Marc, and then Sean can cover MYSTIC and 006.
如果我們從毛利率和財務問題開始,馬克,然後肖恩可以報導《神秘島》和《006》。
Marc Dunoyer - CFO
Marc Dunoyer - CFO
Okay.
好的。
So I think the impact of Crestor is real; over time, it's going to disappear and the transition to a more specialty care type of portfolio is going to compensate for it.
所以我認為 Crestor 的影響是真實的;隨著時間的推移,它將會消失,而向更專業的護理類型的投資組合的過渡將彌補它。
But on the last quarter of the year 2016, and for the year 2017, the reduction on gross margin will be felt.
但在2016年最後一個季度以及2017年,毛利率將會有所下降。
So the gross margin in 2017 will be lower than what we see for the year 2016, that's clear.
因此,2017 年的毛利率將低於我們預計的 2016 年,這是顯而易見的。
Maybe in the third quarter, the impact of Crestor was not -- if you total the three quarters were not that high.
也許在第三季度,Crestor 的影響並不大——如果你把三個季度加起來的話,影響並沒有那麼大。
But as we see the fourth quarter, there was a difference in the percentage of gross margin.
但正如我們看到的第四季度,毛利率百分比存在差異。
And we have reported on the report, there was, on the fourth quarter, 260 basis points on the fourth quarter alone, at CER, and 130 basis points at actual rates.
我們已經在報告中報告過,第四季度,按固定匯率計算,僅第四季度就上漲了 260 個基點,按實際匯率計算,則上漲了 130 個基點。
So we are, in a way, helped a little bit by the depreciation of the sterling pound, and other similar currencies.
因此,在某種程度上,英鎊和其他類似貨幣的貶值對我們有所幫助。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
2018, Marc?
2018 年,馬克?
Marc Dunoyer - CFO
Marc Dunoyer - CFO
For 2018?
2018年?
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
2018, yes.
2018年,是的。
Marc Dunoyer - CFO
Marc Dunoyer - CFO
So I think the gross margin is going to be lower in 2017 than in 2016.
所以我認為2017年的毛利率將會低於2016年。
For 2018, I think we should have a very similar gross margin --
對於 2018 年,我認為我們的毛利率應該非常相似——
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Sorry to interrupt, the question was external revenue and OI.
抱歉打擾一下,問題是外部收入和 OI。
Marc Dunoyer - CFO
Marc Dunoyer - CFO
So we're not going to provide guidance today for 2018.
因此,我們今天不會提供 2018 年的指導。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Wait a little bit.
稍等一下。
Marc Dunoyer - CFO
Marc Dunoyer - CFO
We gave you as much as we could; a lot of details about 2017, different lines of our P&L, an indication of the total of external revenue and other income.
我們給了你盡可能多的東西;關於 2017 年的很多詳細信息,我們損益表的不同行,表明外部收入和其他收入的總額。
I think I'm going to stop there, I think.
我想我就到此為止了。
I can't provide you with any more detail for 2018.
我無法向您提供 2018 年的更多詳細信息。
But I can certainly say that a return to growth is imminent, and it could happen at the end of 2017 or early 2018.
但我可以肯定地說,恢復增長即將到來,並且可能會在 2017 年底或 2018 年初發生。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Richard, you'll also, I'm sure, appreciate the fact that this will be very much influenced by the mix in the portfolio, right.
理查德,我相信你也會意識到這將在很大程度上受到投資組合組合的影響,對吧。
And as a result, be influenced by the clinical news flow and what comes out.
因此,會受到臨床新聞流和結果的影響。
We've got so many new clinical data coming out over the next 12 months.
未來 12 個月我們將獲得大量新的臨床數據。
That will influence the product mix of 2018 and, therefore, the speed at which we grow, but also the gross margin and our profitability.
這將影響 2018 年的產品組合,進而影響我們的增長速度,同時也會影響毛利率和盈利能力。
So I really think that to be able to be more specific on 2018, we need to have a better understanding of what the portfolio will look like actually.
所以我真的認為,為了能夠更具體地了解 2018 年,我們需要更好地了解投資組合的實際情況。
Sean?
肖恩?
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Yes.
是的。
So with regard to an update on 006 data, it's really the same as the answer to Sachin's question, which is when the data is at a place where it's a meaningful publication, we will submit it and we'll update.
因此,關於006數據的更新,這實際上與Sachin問題的答案相同,即當數據處於有意義的發布位置時,我們將提交它並進行更新。
But we don't do it at an analyst meeting.
但我們不會在分析師會議上這樣做。
And as I said, our confidence in MYSTIC is unchanged.
正如我所說,我們對 MYSTIC 的信心沒有改變。
It's a good point that durva/treme therapeutic hypothesis is not yet proven in 1st-line or 2nd-line non-small cell lung cancer.
值得指出的是,durva/treme 治療假說尚未在一線或二線非小細胞肺癌中得到證實。
And so it is an experiment, but we believe we're doing the right experiment, and the trial is well designed.
所以這是一個實驗,但我們相信我們正在做正確的實驗,而且試驗設計得很好。
You also asked about -- and I would say, I think Pascal said it, our enthusiasm for the trial really hasn't changed.
你還問到——我想說,我認為帕斯卡說過,我們對試驗的熱情確實沒有改變。
The BMS announcement; part of what you're asking is, what did BMS see.
BMS公告;你所問的部分內容是,BMS 看到了什麼。
I don't know any more than you do about what BMS saw, so I can't say whether their change in tone is reflecting something in the data, that if we knew it, would reflect our PTS.
我對 BMS 所看到的情況的了解並不比你多,所以我不能說他們語氣的變化是否反映了數據中的某些內容,如果我們知道的話,就會反映我們的 PTS。
I'm sorry, I just can't answer that question.
抱歉,我無法回答這個問題。
I will say that, as I said, it was our assumption that that accelerated approval path wouldn't work.
我要說的是,正如我所說,我們的假設是加速審批路徑行不通。
So to now have confirmation that it's not working again doesn't change our confidence, because that's what we thought was going to happen anyway.
因此,到目前為止,確認它不再起作用並不會改變我們的信心,因為這就是我們認為無論如何都會發生的情況。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
One of the things that we also learned, not us as a company, but as an industry, I believe is, over the last maybe 12, 18 months is that overall survival is really the end game in immuno-oncology.
我相信,我們(不是作為一家公司,而是作為一個行業)還學到的一件事是,在過去的 12、18 個月裡,整體生存確實是免疫腫瘤學的最終遊戲。
And the other thing that we have more recently reconfirmed, that what happened to BMS it's not necessarily the best thing to do, to look at your data every week or month, or something, and then publish things, because then you have a lot of liability in what you publish.
我們最近再次確認的另一件事是,BMS 發生的事情不一定是最好的做法,每週或每月查看您的數據,然後發布一些東西,因為這樣您就有很多您發布的內容的責任。
So our approach is, we want to get to a stage where we have a sufficient number of patients, maturity in the data, overall survival data, and then publish that.
所以我們的方法是,我們希望達到一個擁有足夠數量的患者、成熟的數據、總體生存數據的階段,然後發布這些數據。
And so that will be probably second half of this year at the [August Congress] we can actually publish that.
因此,這可能會在今年下半年的[八月大會]上我們實際上可以發布。
But we really want to get a mature dataset, and then share that, at that point, as opposed to sharing data and doing that too often.
但我們確實希望獲得一個成熟的數據集,然後在那時共享它,而不是過於頻繁地共享數據。
And so the basis of the adjustment of the plans around MYSTIC was our own internal data, but also the external data.
所以圍繞MYSTIC調整計劃的依據是我們自己的內部數據,還有外部數據。
As we always said, we would look at pembro, nivo data, presented at ESMO, we would look at our own data.
正如我們總是說的,我們會查看 ESMO 上提供的 pembro、nivo 數據,我們會查看我們自己的數據。
And then, based on that, inform the final statistical analysis of MYSTIC.
然後,在此基礎上,為 MYSTIC 進行最終的統計分析。
And essentially, looking at OS as a critical endpoint, but also looking a cutoff point and that's basically what we've done.
從本質上講,將操作系統視為一個關鍵端點,同時也將其視為一個分界點,這基本上就是我們所做的。
Another question in the room, and maybe we'll go online for one or two questions.
房間裡還有另一個問題,也許我們會上網回答一兩個問題。
Nicolas Guyon-Gellin - Analyst
Nicolas Guyon-Gellin - Analyst
Nicolas Guyon-Gellin, Morgan Stanley.
尼古拉斯·蓋永-傑林,摩根士丹利。
Three MYSTIC-related questions, I'm afraid, all for Sean.
恐怕三個與 MYSTIC 相關的問題都是肖恩的。
The first one is around the recent changes.
第一個是關於最近的變化。
I noted a slight change in the wording of the press release, where you now refer to PD-L1 expressing tumors, rather than positive or high expressers.
我注意到新聞稿的措辭略有變化,現在指的是表達 PD-L1 的腫瘤,而不是陽性或高表達者。
Does that influence your thinking about PD-L1 expression and/or your cutoff in any way?
這是否會以任何方式影響您對 PD-L1 表達和/或截止值的思考?
Second, with regards to the readout and the timeline; the first patient dose in MYSTIC was in Q3 2015, and the last patient commenced dosing in early Q3 2016, which means that you have a minimum of follow-up of at least 12 month, up to 24.
第二,關於讀數和時間線; MYSTIC 的首例患者用藥是在 2015 年第三季度,最後一位患者是在 2016 年第三季度初開始用藥,這意味著您至少需要 12 個月、最多 24 個月的隨訪。
So basic average, assuming straight line recruitment, 18 months.
所以基本平均,假設直線招聘,18 個月。
This is much more than what Merck had in Keynote24, in which they demonstrated overall survival.
這比默克公司在 Keynote24 中展示的整體生存率要高得多。
So are we missing something, or, basically, what precludes you from showing OS data as early as mid-2017?
那麼我們是否遺漏了一些東西,或者基本上是什麼阻止您最早在 2017 年中期顯示操作系統數據?
And the final one is with regard to the dosing regimen of the CTLA-4.
最後一個是關於 CTLA-4 的給藥方案。
Just conceptually, I would like to hear your thoughts on the two different approaches; the one of BMS and your approach.
就概念而言,我想听聽您對這兩種不同方法的想法; BMS 和您的方法之一。
As far as I understand, you will dose treme only for four cycles, whereas BMS may dose until progression.
據我了解,您只會在四個週期內服用 treme,而 BMS 可能會一直服用直至出現進展。
What are the pros and cons?
優缺點都有什麼?
Thank you.
謝謝。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Three questions, Sean.
三個問題,肖恩。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Yes.
是的。
Somebody, I'm sure, has a non-MYSTIC question, but maybe we'll get to that.
我確信有人有一個不神秘的問題,但也許我們會解決這個問題。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
I've noticed that.
我注意到了這一點。
The first one, PD-L1 expressers.
第一個,PD-L1 表達者。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Let me try and take them backwards, and then maybe you'll remind me of the first one.
讓我試著把它們倒過來,然後也許你會讓我想起第一個。
So the question about the overall survival, endpoint and maturity, these are event-driven analyses.
因此,關於總體生存期、終點和成熟度的問題,這些都是事件驅動的分析。
And what we share with you is when the final analysis will be done.
我們與您分享的是最終分析何時完成。
We think, right, because if the event rate is slower or faster than we forecast, then the trial matures at a different rate, and overall survival will be mature in 2018.
我們認為是對的,因為如果事件發生率比我們預測的慢或快,那麼試驗就會以不同的速度成熟,總體生存期將在 2018 年成熟。
As we get closer, we'll be able to narrow it down to a quarter.
當我們越來越接近時,我們將能夠將範圍縮小到四分之一。
As always with these trials, there are IDMCs, there are interim analyses, and we just don't share timing for that.
與往常一樣,這些試驗有 IDMC,有中期分析,但我們只是不分享具體時間。
So PFS is midyear; we're getting close enough that we can say that.
所以 PFS 是年中;我們已經足夠接近了,我們可以這麼說。
And for overall survival, we're still giving a big range.
為了整體生存,我們仍然給出了很大的範圍。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
The only thing I could add, if I may, is that in terms of the level of maturity that you're referring to please keep in mind that, maybe we didn't communicate that clearly before, is that we increased the size of MYSTIC, as Sean explained.
如果可以的話,我唯一可以補充的是,就您所指的成熟度而言,請記住,也許我們之前沒有明確傳達這一點,那就是我們增加了 MYSTIC 的規模正如肖恩解釋的那樣。
And we had a team that did a fantastic job, accelerated the recruitment.
我們的團隊做得非常出色,加快了招聘速度。
But the end result of this was that the recruitment accelerated toward the end of the trial, and a large proportion of the patients were recruited in the last two or three months of the trial.
但這樣做的最終結果是,招募在試驗接近尾聲時加速,很大一部分患者是在試驗的最後兩三個月招募的。
I can't exactly remember the percentages, you may have them, or maybe we don't want to comment on them; I don't know, Sean, it's up to you really.
我不太記得百分比了,你可能有,或者我們不想對它們發表評論;我不知道,肖恩,這真的取決於你。
But a lot of those patients were recruited in sort of June, July, August and, therefore, we don't have as much follow-up as you may think we have.
但很多患者是在六月、七月、八月招募的,因此,我們沒有像你想像的那樣進行那麼多的隨訪。
But certainly, there will be quite a number of patients who would have a reasonable follow-up by mid-June this year, for sure.
但可以肯定的是,到今年六月中旬,肯定會有相當多的患者得到合理的隨訪。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
That's well, more than half are in their shorter follow-up period just because of the shape of the recruitment curve.
好吧,由於招募曲線的形狀,超過一半的人處於較短的隨訪期。
Cut-offs, yes, you've definitely caught a change in the wording.
截斷,是的,你肯定注意到了措辭的變化。
And it does have to do with how we've informed our definition of PD-L1 positive in the trial and enabled the analysis plan to look at that population, again both for durva monotherapy and for durva+treme combination.
這確實與我們如何在試驗中告知 PD-L1 陽性定義以及如何使分析計劃能夠研究該人群有關,同樣適用於 durva 單藥療法和 durva+treme 組合療法。
We aren't communicating more details around that; obviously, very competitive landscape so for us, it's important that we keep some of these things to ourselves until we're ready to share information with you from the trial.
我們不會就此傳達更多細節;顯然,競爭非常激烈,因此對我們來說,在我們準備好與您分享試驗信息之前,我們必須將其中一些事情保密,這一點很重要。
What was the first one?
第一個是什麼?
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Dosing of CTLA-4 for multiple cycles
CTLA-4 多個週期的給藥
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Excellent, yes.
非常好,是的。
So if you look at the biology of CTLA-4 versus PD-1, PD-L1 as a checkpoint inhibitor, it's a little bit of the PD-1, PD-L1 pressing on the gas and CTLA-4 being a brake.
因此,如果你看看CTLA-4 與PD-1、PD-L1 作為檢查點抑製劑的生物學特性,就會發現,PD-1、PD-L1 有點像踩油門,而CTLA-4 則像剎車。
It is our belief, from preclinical data and the mechanism of action of CTLA-4, that once you have removed that suppressive signal that you should, over the months that you would have CTLA-4 inhibition, you should allow the stimulation of the immune system, as necessary, to fight the cancer if it's going to be able to.
我們相信,根據臨床前數據和 CTLA-4 的作用機制,一旦您消除了應該消除的抑制信號,在您將受到 CTLA-4 抑制的幾個月內,您應該允許刺激免疫系統如果有能力的話,系統會根據需要來對抗癌症。
And once they're activated, they aren't subject to CTLA-4 suppression any more, and so that's the basis for that.
一旦它們被激活,它們就不再受到 CTLA-4 抑制,這就是其基礎。
It's a small dataset, but if you look at what's probably the best pharmaco-dynamic marker of immunotherapy activity, it's actually autoimmune toxicity.
這是一個很小的數據集,但如果你看看免疫治療活性的最佳藥效學標誌物是什麼,它實際上是自身免疫毒性。
And if you look at the two regimens they actually look quite similar.
如果你看一下這兩種療法,它們實際上看起來非常相似。
The one that BMS finished with, not the one they started with, because they started with a much higher dose of CTLA-4 with much more toxicity, if you go to the interval in dose they finished with, the autoimmune AEs look quite similar.
BMS 完成的那一個,而不是他們開始的那一個,因為他們開始時使用了更高劑量的CTLA-4,毒性也更大,如果你觀察他們完成的劑量間隔,自身免疫性AE 看起來非常相似。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
So maybe before we come back to the room, we'll take one question online.
因此,也許在我們回到房間之前,我們會在網上回答一個問題。
Seamus Fernandez, Leerink.
謝默斯·費爾南德斯,萊林克。
Seamus Fernandez - Analyst
Seamus Fernandez - Analyst
(technical difficulty)
(技術難度)
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Seamus.
謝謝,西莫。
So the first two questions, Sean, they're for you.
所以前兩個問題,肖恩,是給你的。
And I'm sure you'll enjoy the first one because you love Tagrisso, and there's so much focus on MYSTIC these days that this little child called Tagrisso, which has a very, very, promising future, tends to be overlooked a little bit.
我相信你會喜歡第一個,因為你喜歡 Tagrisso,而且現在人們對 MYSTIC 的關注如此之多,以至於這個名叫 Tagrisso 的小孩子,它有一個非常非常有前途的未來,往往被忽視了一點。
Go ahead.
前進。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Thank you for the question.
感謝你的提問。
I loved the introduction to it because I am very enthusiastic about FLAURA.
我喜歡它的介紹,因為我對 FLAURA 非常熱情。
I'm going to get Mark Mallon to help with this two from the front, because there was a question about what's the threshold with regard to payers and access to the market.
我將讓馬克·馬倫(Mark Mallon)從前面幫助解決這兩個問題,因為有一個問題是付款人和進入市場的門檻是多少。
First of all, just to talk about the trial a little bit.
首先,簡單談談審判。
As I mentioned, frontline EGFR-mutated Iressa versus Tagrisso, the things I'll mention here -- a few things we're going to look at there that can really distinguish.
正如我提到的,一線 EGFR 突變易瑞莎與 Tagrisso 的比較,我將在這裡提到的一些事情 - 我們將在那裡觀察一些可以真正區分的事情。
Obviously, progression-free survival we need to show that Tagrisso is better and that is has greater activity.
顯然,我們需要證明 Tagrisso 的無進展生存期更好,並且具有更強的活性。
We have a couple of things that lead us to think that that's a possibility.
有幾件事讓我們認為這是有可能的。
One, as I mentioned is the CNS penetration, the ability to cross the blood-brain barrier.
一,正如我提到的,是中樞神經系統滲透性,即穿過血腦屏障的能力。
We know that in the range of 40% of patients when they progress on a first-generation TKI for EGFR progress in the central nervous system and those first-generation medicines just don't penetrate.
我們知道,有 40% 的患者在接受第一代 EGFR TKI 治療後,中樞神經系統出現進展,而這些第一代藥物卻無法滲透。
So they're not being treated there.
所以他們沒有在那裡接受治療。
So that's one opportunity.
所以這是一個機會。
The second one is the obvious thing; it was designed to suppress T790 mutation, which is the most common mutation that leads to resistance of the first generation EGFR inhibitors and so this suppresses that.
第二個是顯而易見的事情;它旨在抑制 T790 突變,這是導致第一代 EGFR 抑製劑產生耐藥性的最常見突變,因此可以抑制這種突變。
So those are the opportunities.
這些就是機會。
In terms of difference and how it relates to the market and payer?
就差異而言,它與市場和付款人有何關係?
Mark Mallon - EVP Global Portfolio & Product, Global Medical Affairs, Corporate Affairs & International West
Mark Mallon - EVP Global Portfolio & Product, Global Medical Affairs, Corporate Affairs & International West
I would just say a couple of comments.
我只想說幾點意見。
I think, and you probably won't be satisfied with this, but it's variable because the actual 1st-line treatment of lung cancer is quite variable across the world.
我認為,您可能不會對此感到滿意,但它是可變的,因為肺癌的實際第一線治療在世界各地差異很大。
So you're going to have -- if you're in health technology assessment market, there would be high expectations about the progression-free survival.
因此,如果您從事健康技術評估市場,您會對無進展生存期抱有很高的期望。
They're going to be really challenging in getting on to the details of what the economic implications of that are.
他們在了解其經濟影響的細節方面確實具有挑戰性。
And that will be probably a higher bar than, say, something in the US where they're really primarily focused on, is this really extending progression a reasonable amount for patients and, therefore, that will be a driver.
這可能會比美國的標準更高,在美國,他們真正主要關注的是,這是否真的能將患者的進展延長到合理的範圍,因此,這將成為一個驅動因素。
And then, of course, outside the US and Europe where a lot of this is in out of pocket markets.
當然,在美國和歐洲之外,其中很多都是在自付費用市場。
In some cases you're talking it's still largely -- there are markets where chemo is still the primary 1st-line treatment.
在某些情況下,您所說的情況仍然很大程度上是——在某些市場上,化療仍然是主要的一線治療方法。
It's not even the TKIs and I wouldn't rule those out as good opportunities for FLAURA because people may say, why go to this interim step?
甚至不是 TKI,我不會排除這些對 FLAURA 來說是很好的機會,因為人們可能會說,為什麼要採取這個臨時步驟?
Let me jump to the better therapy if I'm going to be paying out of pocket.
如果我要自掏腰包,讓我跳到更好的治療。
So we're going to have to work on this, as I say, a healthcare system by healthcare system model, assuming -- once we see the data.
因此,正如我所說,我們將不得不致力於建立一個醫療保健系統模型,假設 - 一旦我們看到數據。
That's the mindset or the framework we're going to have to think about.
這就是我們必須考慮的心態或框架。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
The only thing I would add is that, as Mark has said, will be variable and, as Sean said, it will depend on the strength of the data.
我唯一要補充的是,正如馬克所說,這將是可變的,正如肖恩所說,這將取決於數據的強度。
But there's one place, one type of patient who I really do believe it will be hard to not prescribe Tagrisso in an EGFR-mutation situation, even without the T790 mutation, and that's the 1st-line patient who has brain metastasis.
但有一個地方、一種類型的患者,我確實相信,即使沒有 T790 突變,在 EGFR 突變的情況下也很難不開 Tagrisso,這就是患有腦轉移的一線患者。
Now, think about that patient.
現在,想想那個病人。
You have an EGFR-mutated lung cancer and you have brain metastases, what are you going to do?
您患有 EGFR 突變肺癌並且患有腦轉移,您該怎麼辦?
A first generation EGFR do not penetrate the blood-brain barrier.
第一代 EGFR 不能穿透血腦屏障。
And I just had recently the example, a friend of my wife had this, and then she progressed in her lung.
我最近就有過這樣的例子,我妻子的一個朋友得了這個,然後她的肺部出現了進展。
Her lung disease was controlled and she progressed in the brain very rapidly.
她的肺部疾病得到了控制,大腦的進展也非常迅速。
This is a type of patient who actually will need Tagrisso.
這類患者實際上需要泰瑞沙。
And then, beyond this group of patients the question, of course, will be, what is the strength of the clinical data coming out of FLAURA.
當然,除了這組患者之外,問題還在於 FLAURA 得出的臨床數據的強度如何。
ARCTIC, Sean, do you want to cover that?
北極,肖恩,你想報導這個嗎?
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sure.
當然。
So the question was, ARCTIC results being material, I believe.
所以問題是,我相信北極的結果是重要的。
Unfortunately, the materiality assessment is made in the context of looking at the result of the trial and what would its implications be for the Company, and do we think that that would move the share price, the variety of things that we talk about.
不幸的是,重要性評估是在考慮試驗結果及其對公司有何影響的背景下進行的,我們認為這是否會影響股價以及我們談論的各種事情。
We can't talk about it, except in the context of the data and so that's a determination.
我們不能談論它,除非在數據的背景下,所以這是一個決定。
It's really a question, I think, that we can't answer at this point.
我認為,這確實是一個我們目前無法回答的問題。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
And SG&A, Marc, can you cover that?
SG&A,Marc,你能介紹一下嗎?
Marc Dunoyer - CFO
Marc Dunoyer - CFO
(multiple speakers), I think in 2016 I gave you the percentage or the SG&A ratio of 35.5% and I also mentioned that we were going to continue our effort to reduce the SG&A costs.
(多名發言者),我想在 2016 年我給了你們 SG&A 比率 35.5%,我還提到我們將繼續努力降低 SG&A 成本。
So I think one can surmise that the ratio will continue to go down, maybe not at the same speed as it has gone down in 2016 where in real term, in actual terms, the percentage decrease was about 2%.
因此,我認為人們可以推測該比率將繼續下降,但下降速度可能與 2016 年下降的速度不同,實際上,實際下降的百分比約為 2%。
So I think there will be a further reduction but maybe not as fast as what we saw in 2016.
所以我認為還會進一步減少,但可能不會像 2016 年看到的那麼快。
But, I think, on a medium and long term, this percentage is going to reduce, over time.
但是,我認為,從中長期來看,隨著時間的推移,這個百分比將會減少。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
The only thing I would add to this is that I would not use the industry as a benchmark, because in the industry you have all sorts of companies with different portfolios.
我唯一要補充的是,我不會使用該行業作為基準,因為在該行業中,有各種各樣擁有不同投資組合的公司。
So the benchmark we tend to use is made of companies that have a more similar portfolio to our, and those are companies like Lilly and some others.
因此,我們傾向於使用的基準是由與我們的投資組合更相似的公司組成的,這些公司是禮來(Lilly)和其他一些公司。
It still is that we have potential for a decrease of our SG&A ratio; there's no question about it.
我們仍然有可能降低 SG&A 比率;毫無疑問。
You've got to keep in mind that we have quite a unique position in the emerging markets and we have been driving this pretty hard, in particular in China.
你必須記住,我們在新興市場擁有相當獨特的地位,並且我們一直在努力推動這一點,特別是在中國。
In China, we are now getting to a stage where we have a totally unique position.
在中國,我們現在正處於一個擁有完全獨特地位的階段。
We have a representation across the entire value chain.
我們在整個價值鏈上都有代表。
We are number two.
我們是第二名。
We have 12,000 people; we had 6,000 people three, four years ago.
我們有 12,000 名員工;三四年前,我們有 6,000 名員工。
And we have established ourselves in a place that is quite unique for the future but, of course, it's required investment, so keep all of these points in mind.
我們已經在一個對未來來說非常獨特的地方建立了自己的地位,但當然,這需要投資,所以請記住所有這些要點。
We'll continue reducing SG&A, both in value and as a percentage of revenue.
我們將繼續減少銷售及管理費用(SG&A),無論是價值還是佔收入的百分比。
And, again, maybe that's not a satisfactory response, but the speed at which we can evolve that will very much depend on the portfolio mix we have by next year, essentially.
再說一次,也許這不是一個令人滿意的回應,但我們發展的速度在很大程度上取決於我們明年的投資組合。
So again, it takes us back to the clinical news flow this year; what are the projects that work.
再次讓我們回到今年的臨床新聞流;有哪些有效的項目?
I would love to believe everything's going to work, but some things will work better than others, as always.
我很願意相信一切都會順利,但有些事情會比其他事情更好,一如既往。
And depending on what we have in our hands, we'll be able to allocate our resources and move the SG&A ratio at a different speed.
根據我們手中的資源,我們將能夠以不同的速度分配資源並調整 SG&A 比率。
Shall we go back to the room?
我們回房間吧?
Jack Scannell - Analyst
Jack Scannell - Analyst
Jack Scannell, UBS.
傑克·斯坎內爾,瑞銀集團。
Two questions; one is around the diabetes market in the US.
兩個問題;一是圍繞美國的糖尿病市場。
You implied that the GLP-1 market is having modest negative pricing.
您暗示 GLP-1 市場的負定價適度。
In some ways, it looks like a pretty competitive market, right.
從某些方面來說,這看起來是一個競爭相當激烈的市場,對吧。
There's aggressive contracting already, from new management and number of players, but other insulin segments would love to have mildly negative pricing, which implies in some ways the pricing power that you've been able to maintain in the GLP-1 segment is better than, for example, the insulin players see.
新的管理層和參與者數量已經在積極簽訂合同,但其他胰島素細分市場希望有輕微的負定價,這在某種程度上意味著您在GLP-1 細分市場中能夠維持的定價能力優於例如,胰島素玩家看到的。
Is there something structural about the GLP-1 segment that makes it different and do you expect that to continue?
GLP-1 細分市場是否存在某種結構性因素使其與眾不同,您預計這種情況會持續下去嗎?
That's the first question.
這是第一個問題。
The second question is around Alzheimer's.
第二個問題是關於阿爾茨海默氏症的。
Our view is that US payers have got, in the last few years, very, very good at stamping on drugs with high budget impact, even if they might save money in the long run.
我們的觀點是,在過去幾年中,美國付款人非常非常擅長對預算影響較大的藥品進行印花稅,即使從長遠來看他們可能會省錢。
And that is because in the long run, generally someone else insures the patient, so it's hard for them to take a long-term view.
這是因為從長遠來看,通常是由其他人為患者投保,所以他們很難有長遠的眼光。
Do you think that matters for assessing the commercial prospects of Alzheimer's projects and, if so, how do you handicap that in your thinking when you're thinking about whether to engage in Alzheimer's or not?
您認為這對於評估阿爾茨海默氏症項目的商業前景重要嗎?如果是的話,當您考慮是否參與阿爾茨海默氏症研究時,您如何在您的思維中阻礙這一點?
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Mark, do you want to cover those two questions, starting with diabetes versus GLP-1?
Mark,您想從糖尿病與 GLP-1 開始討論這兩個問題嗎?
Mark Mallon - EVP Global Portfolio & Product, Global Medical Affairs, Corporate Affairs & International West
Mark Mallon - EVP Global Portfolio & Product, Global Medical Affairs, Corporate Affairs & International West
Yes.
是的。
In terms of the class, I think there's a number of differences between the injectable business and GLP-1 and oral business.
就類別而言,我認為註射劑業務與GLP-1和口服業務之間存在許多差異。
You can think about obviously the severity of the patients, so as physicians, thinking about how readily they are willing to switch the therapies.
您顯然可以考慮患者的嚴重程度,作為醫生,可以考慮他們是否願意改變治療方法。
Certainly, even just the mix of the business, it can be a bit different between, say, the Medicare party versus commercial, and there are different pricing pressures there.
當然,即使只是業務組合,醫療保險方與商業方之間也可能有所不同,並且存在不同的定價壓力。
And also, really, there's some overlap with the competitors but there's some different ones that have different approaches.
而且,實際上,與競爭對手有一些重疊,但也有一些不同的競爭對手有不同的方法。
So I think overall, in diabetes, we're going to have to deal with pricing pressure; it's going to continue to increase.
所以我認為總的來說,在糖尿病領域,我們將不得不應對定價壓力;它將繼續增加。
Right now, this is part of the reason we're staying interested and focused in both because we want to see how this continues to evolve.
目前,這是我們對兩者保持興趣和關注的部分原因,因為我們想看看這將如何繼續發展。
Right now, we feel very confident with what we've got with Forxiga and we're able to drive very significant growth, and continue to lead that class.
目前,我們對 Forxiga 所取得的成果非常有信心,我們能夠推動非常顯著的增長,並繼續引領這一類別。
And we've got some exciting things coming for Bydureon which we think will be a differentiator and allow us to compete in the future in that as well.
我們為 Bydureon 帶來了一些令人興奮的事情,我們認為這將成為一個差異化因素,並使我們在未來也能在這方面競爭。
So it's not a silver bullet or one particular thing that causes the difference, at least in my view.
因此,至少在我看來,這並不是靈丹妙藥或某一特定事物造成的差異。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Keep in mind that the insulin prices have been going up very substantially over the last 10 years, and payers knew that, and they were quite high and then they had a long way, potentially, to go down.
請記住,過去 10 年胰島素價格大幅上漲,付款人也知道這一點,而且價格相當高,而且還有很長的路要走,可能還有很長的路要走。
So the potential to go down was larger to start with.
因此,下跌的可能性一開始就更大。
And secondly, you have the additional dimension of the introduction of analogs, and Lilly have been aggressive in launching their analog of basal insulin.
其次,還有引入類似物的額外維度,禮來公司一直在積極推出基礎胰島素類似物。
So the dynamics are a little bit different from what you can see in GLP-1.
因此,動態與您在 GLP-1 中看到的有點不同。
With your question about Alzheimer's, I think you're right that, to some extent, not completely right, but to some extent it is true that sometimes payers worry less about things that will prevent events in the future.
關於你關於阿爾茨海默氏症的問題,我認為你是對的,在某種程度上,不完全正確,但在某種程度上,確實有時付款人不太擔心那些會阻止未來發生事件的事情。
In the case of Alzheimer's, again it will depend on the strength of the clinical data, but I think, if you can actually influence the course of the disease and keep patients stable and at home as opposed to being hospitalized, then essentially payers will be able to see the savings quickly.
就阿爾茨海默氏症而言,這同樣取決於臨床數據的強度,但我認為,如果你能夠真正影響疾病的進程並讓患者保持穩定並在家中而不是住院,那麼基本上付款人將是能夠快速看到節省的費用。
And in fact, the payer in that instance, is going to be the government, because most of those patients are going to be on Medicare Part D.
事實上,在這種情況下,付款人將是政府,因為大多數患者將參加 Medicare D 部分。
So I suspect if we, as an industry, those companies developing products for Alzheimer's, if we get good clinical data, we should be able to gain access for those treatments.
因此,我懷疑,如果我們作為一個行業,那些開發阿爾茨海默氏症產品的公司,如果我們獲得良好的臨床數據,我們應該能夠獲得這些治療方法。
By the way, Thomas proposed that we extend to 2:15 PM, because we saw there were so many questions.
順便說一句,托馬斯建議我們延長到下午 2:15,因為我們看到有很多問題。
Unidentified Audience Member
Unidentified Audience Member
I've got two questions; I'll have the first one in two parts.
我有兩個問題;我將把第一部分分成兩部分。
One's for you, Sean; one's for you, Pascal.
一個是給你的,肖恩;一個是給你的,帕斯卡。
We're all cognizant of how confident and comfortable you are and determined in your hypothesis, but in the unfortunate event that we end up some time in the middle of this year, you open up the data box and at least at PFS neither of the two arms are successful.
我們都知道您是多麼自信和自在,並且對您的假設有堅定的決心,但不幸的是,我們最終在今年年中的某個時候,您打開數據框,至少在PFS 上,兩者都沒有。兩隻手臂都成功了。
Sean, the question for you is, what does that mean in terms of the trial mechanics?
肖恩,你的問題是,這對於審判機制意味著什麼?
What happens the day after to patients on the study?
參加研究的患者第二天會發生什麼?
And Pascal, the question for you is, assuming that the hypothesis fails at OS, what's plan B for returning Astra to growth?
Pascal,你的問題是,假設 OS 的假設失敗,那麼讓 Astra 恢復增長的 B 計劃是什麼?
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Do you mean if OS doesn't read out in MYSTIC?
你的意思是如果操作系統在 MYSTIC 中沒有讀出?
Unidentified Audience Member
Unidentified Audience Member
Yes, or if MYSTIC or the Study 11 is not positive at OS as well, then what's plan B for returning Astra to growth?
是的,或者如果 MYSTIC 或 Study 11 在 OS 方面也不樂觀,那麼讓 Astra 恢復增長的 B 計劃是什麼?
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Okay, so first question for Sean.
好的,第一個問題是問肖恩的。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
So a couple of things.
有幾件事。
When we do the PFS analysis, we're doing it when PFS is mature.
當我們進行 PFS 分析時,我們是在 PFS 成熟時進行的。
So at that point, there will have been many progressions; that's how the maturity of that occurs.
所以到那時,就會有很多進展;這就是成熟的發生方式。
So the patients who have progressed, if they're eligible, will have already gone on to another therapy.
因此,已經取得進展的患者,如果符合條件,將已經開始接受另一種治療。
So it will be a relatively, I think, modest problem.
因此,我認為這將是一個相對溫和的問題。
What happens to the remainder of the patients, whether -- now you've set it up as a negative scenario.
剩下的病人會發生什麼,無論 - 現在你已經將其設置為負面場景。
I personally would not very --
我個人不會很——
Unidentified Audience Member
Unidentified Audience Member
(inaudible)
(聽不清)
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Yes, on the positive scenario I think it depends upon what you're looking at, but then you may -- depending upon how positive you end up in the situation of having to cross patients over and give the chemo patients the IO.
是的,在積極的情況下,我認為這取決於你所看到的內容,但你可能會——取決於你最終在必須越過患者並給化療患者進行 IO 的情況下的積極程度。
In the negative scenario, it will be a physician in-patient assessment, at that point in time, what they feel that they should do should patients go to chemotherapy who were randomized to the IO.
在消極的情況下,這將是醫生住院評估,在那個時間點,他們認為如果患者接受化療並被隨機分配到 IO,他們應該做什麼。
And I think it really will depend upon the details of the data.
我認為這確實取決於數據的細節。
But again, it's not a large subset of patients, because PFS will already be mature at that point in time.
但同樣,這並不是一個很大的患者子集,因為那時 PFS 已經成熟。
Does that answer your question?
這是否回答你的問題?
Unidentified Audience Member
Unidentified Audience Member
Yes.
是的。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
The second one is your question about if OS doesn't read out in MYSTIC and what you mean by that is the combination.
第二個問題是你的問題是操作系統是否沒有在 MYSTIC 中讀出,你的意思是組合。
Unidentified Audience Member
Unidentified Audience Member
Either one.
任意一個。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
The first point is really we believe AstraZeneca will grow, and the question is at what speed will we grow, as I said earlier.
第一點是,我們確實相信阿斯利康會增長,問題是我們將以什麼速度增長,正如我之前所說的。
Because we are all -- many people are mesmerized by this MYSTIC study and, to a great extent rightly so, of course.
因為我們所有人——許多人都對這項神秘的研究著迷,當然,在很大程度上,這是正確的。
But you've got to look at everything we have.
但你必須看看我們擁有的一切。
We have Tagrisso, we have benralizumab to launch, we are launching many products.
我們有Tagrisso,我們有貝那利珠單抗要推出,我們正在推出許多產品。
But also importantly, the massive drag we have had to deal with, these headwinds called patent expiry, is slowly but surely getting behind us now.
但同樣重要的是,我們必須應對的巨大阻力,這些稱為專利到期的逆風,現在正在緩慢但肯定地成為過去。
Price pressures on Symbicort, they're stabilizing in Europe.
Symbicort 面臨價格壓力,它們在歐洲正在趨於穩定。
We still have some of that in the US.
我們在美國仍然有一些。
Crestor has gone soon enough, so we're not going to have to deal with that to the same extent.
克雷斯托很快就離開了,所以我們不需要同樣程度地處理這個問題。
So I think we will grow.
所以我認為我們會成長。
The question is, again it depends on how many of those projects read out.
問題是,這又取決於有多少項目被讀出。
FLAURA; we don't talk about FLAURA but FLAURA is a really fundamental growth driver for us.
芙勞拉;我們不談論 FLAURA,但 FLAURA 對我們來說確實是一個基本的增長動力。
The new indications for Lynparza, they are also very important.
奧拉帕尼的新適應症,它們也非常重要。
The launch of benralizumab, as I said.
正如我所說,貝那利珠單抗的上市。
So we will grow; the question is at what speed.
這樣我們就會成長;問題是速度是多少。
If you come to MYSTIC, my comment here is that, again, we tend to look at MYSTIC in a binary fashion, but it's not binary.
如果你談到 MYSTIC,我在這裡的評論是,我們傾向於以二元的方式看待 MYSTIC,但它不是二元的。
It's not black or white; it is all shades of gray there.
它不是非黑即白;而是非黑即白。那裡都是灰色地帶。
The total negative scenario, meaning nothing works, including monotherapy, hopefully you'll agree with me, it's possible of course but it's sort of low probability.
完全消極的情況,意味著沒有任何作用,包括單一療法,希望你會同意我的觀點,這當然是可能的,但概率很低。
So if we have a monotherapy indication, what it means is we have the durvalumab and it becomes a marketing battle.
因此,如果我們有單一療法適應症,就意味著我們有 durvalumab,這將成為一場營銷戰。
Of course, as we've known all along the way, we are not leading, we are coming later.
當然,正如我們一直以來所知道的那樣,我們並不是領先,而是後來居上。
But remember, in lung cancer which is the biggest indication, we have a very strong presence, historic presence with the Iressa; more recently with Tagrisso.
但請記住,在肺癌這一最大的適應症中,我們的易瑞莎具有非常強大的歷史性地位;最近與 Tagrisso 合作。
We know those physicians.
我們認識那些醫生。
And by the way just a little piece of information, there is 80% overlap between the treatment of bladder cancer and lung cancer.
順便說一句,膀胱癌和肺癌的治療有 80% 的重疊。
The physicians who treat bladder cancer are more or less the same as those who treat lung cancer.
治療膀胱癌的醫生與治療肺癌的醫生或多或少相同。
So from a sales force effectiveness viewpoint it's a very strong synergy.
因此,從銷售隊伍有效性的角度來看,這是一個非常強大的協同效應。
And in lung cancer we are very well positioned, we know those physicians.
在肺癌方面,我們處於非常有利的位置,我們了解那些醫生。
So it's a marketing battle but we have a history there.
所以這是一場營銷戰,但我們在這方面有歷史。
And then from there, the question is, what do we get out of the combination?
然後,問題是,我們能從這個組合中得到什麼?
Do we get benefit versus monotherapy in one a group of positive/negatives, or do we get the benefit in all comers, of course.
當然,我們是否在一組陽性/陰性組中獲得與單一療法相比的益處,或者我們是否在所有方面都獲得了益處。
But my answer to you would be, we will grow; the question is at what speed.
但我對你的回答是,我們會成長;問題是速度是多少。
Unidentified Audience Member
Unidentified Audience Member
The second question, Marc, I want to try my luck in a slightly different way.
第二個問題,馬克,我想以稍微不同的方式試試運氣。
Assuming the pipeline pans out the way you expect it to pan out, what contribution do you need from externalization and OI for 2018 EPS to grow?
假設管道按照您預期的方式進行,您需要外部化和 OI 做出什麼貢獻才能實現 2018 年 EPS 的增長?
Marc Dunoyer - CFO
Marc Dunoyer - CFO
I'm not it's already hard enough to answer your questions on the externalization in 2017, I'm not going to venture on 2018.
我並不是說在 2017 年回答你關於外部化的問題已經夠難的了,我不會在 2018 年冒險。
We believe that externalization is part of our business model.
我們相信外部化是我們商業模式的一部分。
So the part of externalization should continue and the recurring part of externalization is going to grow, over time.
因此,隨著時間的推移,外部化的部分應該繼續下去,並且外部化的經常性部分將會增長。
So I don't think externalization is going to go away, whether MYSTIC is positive or negative.
所以我認為外在化不會消失,無論 MYSTIC 是積極的還是消極的。
Now, the part of other income, after a while, may dwindle a little bit.
現在,其他收入的部分,過一段時間,可能會減少一點。
So this part of product that we divest may be impacted by MYSTIC and also because we have completely finished the management of our portfolio.
所以我們剝離的這部分產品可能會受到MYSTIC的影響,也是因為我們已經徹底完成了對我們投資組合的管理。
But I think the externalization which attracts more attention, is going to stay.
但我認為吸引更多關注的外在化將會繼續存在。
This is part of our business model; we will always have products that we discover, that we are not best placed to market or market on our own.
這是我們商業模式的一部分;我們總會有一些我們發現的產品,這些產品不是我們最適合推向市場或靠我們自己推向市場的。
So this will continue.
所以這將繼續下去。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
And remember, as we have always said, there will be a recurring dimension to those and then the one-offs will, over time, decline.
請記住,正如我們一直所說的那樣,這些都會有一個反復出現的維度,然後隨著時間的推移,一次性的就會減少。
We've also said there will be a time point when the sum of the one-off and the recurring actually reduces a bit before, hopefully, start growing again, based on the recurring revenue.
我們還說過,在某個時間點,一次性收入和經常性收入的總和實際上會減少一點,希望根據經常性收入再次開始增長。
Some of this externalization relates to pipeline projects, as you know.
如您所知,其中一些外部化與管道項目有關。
Some of it is pure divestments but it's relatively limited.
其中一些是純粹的撤資,但相對有限。
Those are small products, [$40 million/$50 million] in sales that would be doing better in the hands of someone else and we divest them and crystallize the value or invest it.
這些都是小產品,銷售額為[4000萬美元/5000萬美元],如果放在其他人手中會做得更好,我們剝離它們並使其價值具體化或進行投資。
But a big chunk is also about commercial partnerships.
但其中很大一部分還與商業夥伴關係有關。
Plendil is a good example.
Plendil 就是一個很好的例子。
And here with Plendil what we've done, for instance, is we felt this is a product that has potential in China.
例如,我們在 Plendil 方面所做的就是,我們認為這是一種在中國具有潛力的產品。
We can't focus on it, first of all because we have too many things to do; secondly, because you have to cover too many physicians.
我們無法集中精力,首先是因為我們有太多的事情要做;其次,因為你必須照顧太多的醫生。
We have 7,000 medical representatives in China.
我們在中國有7000名醫療代表。
A Chinese company has 25,000 to cover the entire country.
一家中國公司有25000人,覆蓋全國。
So we've partnered this product with a Chinese company, we've given them a margin and they will cover the whole country, and we're doing this with a number of products.
因此,我們與一家中國公司合作了該產品,我們給了他們一定的利潤,他們將覆蓋整個國家,我們正在通過許多產品來做到這一點。
What that means is we have a one-off reset, so we drop, of course, what we give them -- not give them, we sell them a share of this margin.
這意味著我們有一個一次性的重置,所以我們當然會放棄我們給他們的東西——不是給他們,而是我們賣給他們一部分利潤。
But then the problem with the products, over time it will grow again.
但隨著時間的推移,產品的問題又會再次出現。
That's sort of the model, and we'll keep doing this.
這就是一種模式,我們將繼續這樣做。
Essentially, what we try to do is find value everywhere we can in the portfolio, focusing our investment in our own R&D and our own pipeline and looking value outside, everywhere we can and reinvest it.
從本質上講,我們試圖做的是在投資組合中盡可能地尋找價值,將投資重點放在我們自己的研發和我們自己的管道上,並儘可能地尋找外部價值並將其再投資。
So we'll continue doing it.
所以我們會繼續這樣做。
Maybe we'll take one question from [Luca Issi, Cowen], online.
也許我們會在線回答 [Luca Issi, Cowen] 的一個問題。
Luca, go ahead.
盧卡,繼續吧。
Luca Issi - Analyst
Luca Issi - Analyst
I have three non-MYSTIC questions, I guess.
我想我有三個非神秘問題。
So the first is, I think at ASH we have seen the first two cases of atrial fibrillation for acalabrutinib in patients that were actually previously on Imbruvica.
首先,我認為在 ASH 上,我們已經看到了前兩例因 acalabrutinib 治療而出現心房顫動的病例,而這些患者實際上之前都在接受 Imbruvica 治療。
So how confident are you that these cases are driven by prior Imbruvica's treatment and not by actually acalabrutinib?
那麼,您對這些病例是由先前的 Imbruvica 治療而非實際上的 acalabrutinib 驅動的信心有多大嗎?
And maybe more broadly, how does this impact your ability to differentiate the asset?
也許更廣泛地說,這對您區分資產的能力有何影響?
And then second question is on Farxiga.
第二個問題是關於 Farxiga 的。
Can you just provide your high level thoughts on how competitor dynamics will change, going forward, in the US, given that now Jardiance has a proper CV indication on their label?
鑑於現在 Jardiance 在其標籤上有適當的簡歷指示,您能否提供您對美國競爭對手動態將如何變化的高層次想法?
And then third question is on Bydureon; can you just remind us if there is any interim look at the cardiovascular outcome study for Bydureon?
第三個問題是關於Bydureon;您能否提醒我們是否對 Bydureon 的心血管結果研究有任何中期觀察?
Thank you.
謝謝。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks very much, Luca.
非常感謝,盧卡。
Sean, do you want to cover the acalabrutinib ASH question, atrial fibrillation and maybe also the Bydureon cardiovascular data?
Sean,您想報導 acalabrutinib ASH 問題、心房顫動以及 Bydureon 心血管數據嗎?
And, Mark, if you could cover the Farxiga potential?
馬克,您能否發揮 Farxiga 的潛力?
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
So I'll start with the Bydureon one, I think.
所以我想我將從 Bydureon 開始。
These large cardiovascular outcomes, trials have again independent data monitoring committees and interim analysis.
這些大型心血管結局試驗再次有獨立的數據監測委員會和中期分析。
And then we don't give detail about those things when they're happening.
然後我們不會在這些事情發生時提供詳細信息。
Obviously, it's hard because they're all so event-driven, and then IDMCs don't communicate anything to us if they don't feel they need to.
顯然,這很難,因為它們都是事件驅動的,如果 IDMC 認為不需要,就不會與我們溝通任何信息。
But it's got all the normal structures that a large CV outcome trial would have.
但它具有大型 CV 結果試驗所具有的所有正常結構。
Yes, with regard to acalabrutinib and I would say, its tolerability profile in general, we remain committed that acalabrutinib has a superior tolerability profile to ibrutinib, if only because there are patients who are not progressing on ibrutinib who discontinue it because they have toxicity.
是的,關於acalabrutinib,我想說的是,它的總體耐受性概況,我們仍然致力於acalabrutinib 具有優於ibrutinib 的耐受性,即使只是因為有些患者服用ibrutinib 沒有進展,但因為有毒性而停止使用。
Some of that is atrial fibrillation; some of that is a variety of other things.
其中一些是心房顫動;另一些則是心房顫動。其中一些是其他各種事情。
We outlined them in a slide deck, actually when we did the deal.
事實上,當我們完成交易時,我們在幻燈片中概述了它們。
When you go into an older patient population, such as those that have CLL, you are going to have some atrial fibrillation occur.
當您進入老年患者群體時,例如患有 CLL 的患者,您將會出現一些心房顫動。
The dataset we presented at ASH is very small and what is really going to be important is the longer-term chronic therapy dataset that we get.
我們在 ASH 上提供的數據集非常小,真正重要的是我們獲得的長期慢性治療數據集。
And recalling as well that we are doing a head-to-head trial of ibrutinib versus acalabrutinib, which is really going to be the gold standard for looking at tolerability and also, potentially, efficacy in that trial.
還要回顧一下,我們正在進行 ibrutinib 與 acalabrutinib 的頭對頭試驗,這確實將成為該試驗中觀察耐受性以及潛在療效的黃金標準。
And that's what's going to tell us what happens.
這就是將告訴我們會發生什麼的。
But the idea that in CLL patients you were never going to see an atrial fibrillation is probably not very realistic, given their co-morbidities and the age of onset of the disease.
但考慮到 CLL 患者的合併症和發病年齡,認為在 CLL 患者中永遠不會出現房顫的想法可能不太現實。
That's it.
就是這樣。
Mark Mallon - EVP Global Portfolio & Product, Global Medical Affairs, Corporate Affairs & International West
Mark Mallon - EVP Global Portfolio & Product, Global Medical Affairs, Corporate Affairs & International West
Yes, it's a great question, one we're certainly spending a lot of time thinking about.
是的,這是一個很好的問題,我們確實花了很多時間思考這個問題。
So the first thing I would say as we think about the data that our competitor has and, eventually, there could be more data from all of the products in SGLT2, is that it's important data.
因此,當我們考慮競爭對手擁有的數據以及最終可能從 SGLT2 中的所有產品獲得更多數據時,我要說的第一件事是,它是重要的數據。
Obviously, in the limited patient group that that was focused on, which is a minority of the diabetes patients, it had important benefit.
顯然,在所關注的有限患者群體(即少數糖尿病患者)中,它具有重要的益處。
But I guess the question we've been asking ourselves is, why hasn't that had a bigger impact on the overall SGLT2 class growth rate?
但我想我們一直在問自己的問題是,為什麼這沒有對 SGLT2 類別的整體增長率產生更大的影響?
And also, actually even it's been uneven with the sheer impact that we've seen on the brain.
而且,實際上,我們所看到的對大腦的巨大影響甚至是不平衡的。
And I think we have to remember that, first and foremost, we're talking about diabetes patients, right?
我認為我們必須記住,首先也是最重要的是,我們談論的是糖尿病患者,對嗎?
And so for many of these physicians, their first question is, what do I need to do to get the glucose under control, how well tolerated, how safe is this going to be, versus the products I've been using, which in this case is the DPP4s.
因此,對於這些醫生中的許多人來說,他們的第一個問題是,與我一直在使用的產品相比,我需要做什麼才能控制血糖,耐受性如何,安全性如何?案例是DPP4 。
And the DPP4s are a really good product.
DPP4 是一款非常好的產品。
Physicians have become incredibly comfortable with them because they get good glucose reduction and they're very well tolerated.
醫生對它們感到非常滿意,因為它們可以很好地降低血糖,而且耐受性很好。
They don't have to worry about them.
他們不必擔心他們。
And so I think the thing that we feel like is going to be the key dynamic that we need to look at, and see how that is going to happen, is what is going to get physicians to really understand that actually the SGLT2s is a better choice after metformin because of the really good glucose control, because of the weight loss, and then because of also the potential this class has around cardiovascular benefits.
因此,我認為我們感覺的事情將成為我們需要關注的關鍵動態,並了解這將如何發生,這將使醫生真正了解 SGLT2 實際上是更好的選擇二甲雙胍後,因為確實能很好地控制血糖,因為可以減輕體重,還因為該類藥物在心血管方面具有潛在的益處。
And so I think what we'll see evolving over the next couple of years is we will get more CV data, both in clinical trials but also, importantly, in real-world evidence.
因此,我認為未來幾年我們將看到的發展是,我們將獲得更多的 CV 數據,不僅是在臨床試驗中,而且重要的是在現實世界的證據中。
I think we believe that will support the CV benefits of this class.
我認為我們相信這將支持此類的簡歷優勢。
But I think the Company or as a group of companies, when we can get that combined with the core benefits that this class offers us on diabetes control, in a way that physicians can really see that it is worth taking something that's very easy for them to do, which is keep using the DPP4s, and use this new class.
但我認為公司或作為一個公司集團,當我們能夠將其與該課程為我們提供的糖尿病控制核心益處相結合時,醫生可以真正看到值得採取對他們來說非常容易的東西要做的,就是繼續使用DPP4,並使用這個新類。
That's when we will see, really, I think a significant change in the SGLT2 class growth, and I think the company that can really position the product as having the full benefits is going to be successful.
到那時我們會看到,我認為 SGLT2 級增長確實會發生重大變化,而且我認為能夠真正將產品定位為具有全部優勢的公司將會取得成功。
I would stress this; I don't think CV outcomes is a silver bullet.
我要強調這一點;我不認為簡歷結果是靈丹妙藥。
It's an important additional piece of information and for certain patients it's going to be important.
這是一條重要的附加信息,對於某些患者來說非常重要。
But ultimately, the company that can win by -- or the class that can win is really helping physicians understand why this is a better choice as used after metformin.
但最終,能夠獲勝的公司或能夠獲勝的類別確實可以幫助醫生理解為什麼這是繼二甲雙胍之後使用的更好的選擇。
And in that case, and why we're continuing to be the leader and why we feel confident about our successes, we think we've got a great set of messages and story about why Forxiga is a better choice after metformin before DPP4s.
在這種情況下,以及為什麼我們繼續成為領導者以及為什麼我們對我們的成功充滿信心,我們認為我們已經獲得了一系列很好的信息和故事,說明為什麼Forxiga 是繼二甲雙胍之後DPP4 之前的更好選擇。
Great glucose control, great blood pressure and weight loss benefits.
良好的血糖控制、良好的血壓和減肥功效。
And the overall safety and tolerability profile of the product, and the confidence we have at being the most prescribed, is a great starting point to have a discussion with a physician, and then we'll see where DECLARE comes in.
產品的整體安全性和耐受性概況,以及我們對處方最多的信心,是與醫生討論的一個很好的起點,然後我們將看到 DECLARE 的作用。
We've also been doing some work and you'll be seeing, in the course of this year, some really important, we think exciting, real-world evidence that we'll be publishing and we'll see, going forward.
我們也一直在做一些工作,在今年的過程中,你們會看到一些非常重要的、我們認為令人興奮的、現實世界的證據,我們將發布這些證據,我們將會看到,繼續前進。
But I think the key point is we can't forget that these are diabetes patients and we have to treat the whole diabetes patient.
但我認為關鍵是我們不能忘記這些都是糖尿病患者,我們必須治療整個糖尿病患者。
Cardiovascular risk is one part of it; it's an important one and it will grow.
心血管風險是其中之一;它很重要,而且會不斷增長。
But we've got to help physicians understand in the diabetes patient why this is better choice than DPP4s.
但我們必須幫助醫生了解糖尿病患者為什麼這是比 DPP4 更好的選擇。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Mark.
謝謝,馬克。
So should we take one last question?
那麼我們應該回答最後一個問題嗎?
Thomas allowed me to take one last question, so I'll take this one here and then we'll have to close.
托馬斯允許我回答最後一個問題,所以我將在這裡回答這個問題,然後我們就必須結束了。
Miriam Evans - Analyst
Miriam Evans - Analyst
[Miriam Evans, Prime Avenue.] Just a few very quick financial questions.
[Miriam Evans,Prime Avenue。] 只是一些非常簡短的財務問題。
On the US pricing pressure, based on your comments and some of your competitors' comments, is it fair to assume that for Symbicort and maybe some other large drugs, Q1 pricing will be materially below Q4 2016?
關於美國的定價壓力,根據您的評論和一些競爭對手的評論,可以公平地假設對於 Symbicort 和其他一些大型藥物來說,第一季度的定價將大大低於 2016 年第四季度的價格嗎?
And what gives you confidence that pricing pressure is going to moderate in the second half, given that we've always heard that contracts can be reopened at any point in time?
鑑於我們一直聽說合同可以在任何時間點重新開放,是什麼讓您相信下半年價格壓力將有所緩解?
Quick question on Pulmicort growth in the emerging markets, going forward.
關於普米克在新興市場未來增長的快速問題。
If you could just give us a rough steer, because I believe that the China growth has very much been driven by the rollout of nebulization centers and it would just be good to understand where you're at in terms of that.
如果您能給我們一個粗略的指導,因為我相信中國的增長很大程度上是由霧化中心的推出推動的,了解您在這方面的情況會很好。
And my final question is to Pascal on your guidance and your comp.
我的最後一個問題是向帕斯卡詢問您的指導和補償。
If you literally deliver on your guidance, i.e., you don't over-deliver and there's no massive devaluation of the US dollar, is it fair to assume that that would have some negative implications for your deferred comp?
如果您確實兌現了您的指導,即您沒有超額兌現並且美元沒有大幅貶值,那麼可以公平地假設這會對您的遞延補償產生一些負面影響嗎?
If you just could give us a rough feel, that would be great.
如果你能給我們一個粗略的感覺,那就太好了。
Thank you so much.
太感謝了。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thank you.
謝謝。
I thought it was going to be one question; it's three.
我以為這將是一個問題;是三。
Let me deal with the last one quickly so we can move on to more interesting questions.
讓我快速處理最後一個問題,以便我們可以繼續討論更有趣的問題。
We've always said we're committed to the dividend.
我們一直說我們致力於派發股息。
We've always said that if something has to go because of price pressure from currencies, and that's really what we're experiencing, the dollar is gaining strength day after day and it's putting pressure on our ability to deliver the cover at actual rate, it is clear that our comps would be negatively impacted, it's pretty clear.
我們總是說,如果由於貨幣的價格壓力而不得不採取某些措施,而這正是我們正在經歷的,美元日復一日地走強,這對我們以實際匯率提供保障的能力構成壓力,很明顯,我們的比較將受到負面影響,這是很明顯的。
Beyond that, I cannot comment more.
除此之外,我無法發表更多評論。
We continue doing the right thing by the Company and we'll do what we believe is right to do to make sure we maximize the value of this Company because, in the long run, we all win.
我們將繼續為公司做正確的事情,我們將做我們認為正確的事情,以確保我們最大化公司的價值,因為從長遠來看,我們都是贏家。
The patients to start with, us management and the shareholders win, if we do the right thing.
如果我們做正確的事情,首先患者、我們的管理層和股東都會獲勝。
So we continue trying to achieve our short-term goals but, in the end, if we have to prioritize, we prioritize, of course, the dividend in the long term.
因此,我們繼續努力實現短期目標,但最終,如果我們必須優先考慮,我們當然會優先考慮長期紅利。
Pulmicort, Mark, maybe you want to cover this one and let me just quickly cover the Symbicort.
Pulmicort、Mark,也許您想介紹一下這個,讓我快速介紹一下 Symbicort。
We've said that in 2017 we'll see similar price pressure as we've seen in 2016 in the US, with some moderation.
我們說過,2017 年美國將面臨與 2016 年類似的價格壓力,但會有所緩解。
And we've said that this will be worse in the first half than the second half, and I guess maybe we will leave it at that for today.
我們已經說過,上半場的情況會比下半場更糟糕,我想也許我們今天就到此為止。
And then Pulmicort, Mark, since you are the expert in the emerging market.
然後是普米考,馬克,因為你是新興市場的專家。
Mark Mallon - EVP Global Portfolio & Product, Global Medical Affairs, Corporate Affairs & International West
Mark Mallon - EVP Global Portfolio & Product, Global Medical Affairs, Corporate Affairs & International West
Yes, so the short answer is this, that we still have a tremendous amount of work to do to get to all the patients that could benefit from, particularly the kids with asthma, a nebulized solution.
是的,所以簡短的回答是,我們仍然有大量的工作要做,才能讓所有患者,特別是患有哮喘的兒童受益於霧化解決方案。
And I'll say two points on that so -- three points.
我要就此說兩點——三點。
So first of all, in China, I think we actually have some sort of sales on Pulmicort Respules in over 10,000 health institutions.
首先,在中國,我認為我們實際上在 10,000 多家醫療機構中有一定程度的普米克令舒銷售。
I'm not sure we're reaching half of them yet.
我不確定我們是否已經達到了一半。
So it's so massive, the number of hospitals, the number -- and we're just beginning to start to communicate about Pulmicort Respules with community health centers.
因此,醫院的數量如此龐大,我們才剛剛開始與社區衛生中心就普米克令舒進行溝通。
There are 24,000 community health centers.
有社區衛生服務中心2.4萬個。
These are the primary care clinics.
這些是初級保健診所。
They're just starting to actually initiate therapy.
他們才剛剛開始真正開始治療。
So there is still a huge amount of work to do.
所以還有大量的工作要做。
Many places in China kids do not have access to a good option on asthma treatment.
中國許多地方的孩子無法獲得哮喘治療的良好選擇。
The second thing is they shouldn't even be going to the hospital for this treatment.
第二件事是他們甚至不應該去醫院接受這種治療。
The real place they should be doing it is in-home nebulization.
他們真正應該做的地方是家庭霧化。
And we really started working on that in the last two years, but that's going to be a multiyear process to educate on that.
在過去的兩年裡,我們確實開始了這方面的工作,但這將是一個多年的過程。
And then the last point in terms of the rest of emerging markets, we've been spending the last two years basically educating them on what we've done in China and that uplift is just still ahead of us.
最後一點,就其他新興市場而言,過去兩年我們基本上一直在教育他們我們在中國所做的事情,而這種提升仍然就在我們面前。
And we're now seeing nebulization centers come up in Indonesia, in Russia, in other places in the Middle East and Africa.
我們現在看到印度尼西亞、俄羅斯、中東和非洲的其他地方都建立了霧化中心。
Asthma is a terrible -- there's a huge number of kids and people, both asthma and COPD around the world, and this is one solution.
哮喘是一種可怕的疾病——世界各地有大量的兒童和人群患有哮喘和慢性阻塞性肺病,而這是一個解決方案。
Ultimately, we'd like to think the fixed-dose combination inhalers is the way to go but in emerging markets where no Care is still the standard, this is a great solution, so a lot more work to do.
最終,我們認為固定劑量組合吸入器是可行的方法,但在新興市場,無護理仍然是標準,這是一個很好的解決方案,因此還有很多工作要做。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Mark.
謝謝,馬克。
With that, we'll end it here, and thank you so much for your attention.
到這裡我們就結束了,非常感謝您的關注。