使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
We will now hand you over to Chief Executive Officer at AstraZeneca, Pascal Soriot, where the meeting is about to start.
我們現在將您交給阿斯利康公司的首席執行官 Pascal Soriot,會議即將開始。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Very good.
非常好。
[Open]?
[打開]?
Good.
好的。
All right, good afternoon, everybody.
好的,大家下午好。
Good morning to those of you who are joining us by telephone.
早上好,那些通過電話加入我們的人。
Welcome to our full year results presentation, our conference call and webcast to investor and analysts.
歡迎收看我們的全年業績報告、電話會議和麵向投資者和分析師的網絡廣播。
We are here in London.
我們在倫敦。
And we have people with us here in the room, on the phone and on the webcast.
在會議室、電話和網絡廣播中,我們有人和我們在一起。
As usual, the presentation is available, for those of you who want to access it online, at astrazeneca.com for you to download it.
與往常一樣,對於那些想要在線訪問它的人,可以在 astrazeneca.com 上下載該演示文稿。
Please turn to Slide 2. This is our usual safe harbor Statement.
請轉到幻燈片 2。這是我們通常的安全港聲明。
So if we want to move to Slide 3. We plan to spend about 45 minutes on the presentation and keep the rest of the time, the next 45 minutes, for the Q&A.
因此,如果我們要轉到幻燈片 3。我們計劃用大約 45 分鐘的時間進行演示,並保留剩下的時間,即接下來的 45 分鐘,用於問答。
(Operator Instructions) There's also an option to ask questions online as part of the webcast.
(操作員說明)作為網絡廣播的一部分,還可以選擇在線提問。
Please limit yourself to one question in the first round, if you don't mind, so everybody can get a chance to ask a question.
如果您不介意,請在第一輪將自己限制在一個問題上,這樣每個人都有機會提問。
Thank you so much.
太感謝了。
So today, I'm joined by Marc Dunoyer, our CFO; Mark Mallon, our EVP of Global Product and Portfolio Strategy, Global Medical Affairs and Corporate Affairs; Dave Fredrickson, who is EVP and head of our Oncology business unit; and Sean Bohen, our EVP for Global Medicine Development and our Chief Medical Officer.
所以今天,我們的首席財務官 Marc Dunoyer 加入了我的行列; Mark Mallon,我們的全球產品和投資組合戰略、全球醫療事務和公司事務執行副總裁; Dave Fredrickson,執行副總裁兼腫瘤業務部負責人;和 Sean Bohen,我們的全球藥物開發執行副總裁兼首席醫療官。
Please turn to Slide 4. This is the agenda, very standard format.
請轉到幻燈片 4。這是議程,非常標準的格式。
You've seen that many times before.
你以前已經見過很多次了。
If we turn to Slide 5. These are the highlights of the year.
如果我們轉到幻燈片 5。這些是今年的亮點。
And I think we can say that 2017 was indeed a turning point for us.
我認為我們可以說 2017 年對我們來說確實是一個轉折點。
And we made encouraging progress across the entire company, certainly very much from a pipeline viewpoint, but it's also starting to show as far as commercial delivery.
我們在整個公司取得了令人鼓舞的進展,當然從管道的角度來看非常重要,但它也開始顯示出商業交付。
We had accelerated goals in the last quarter, and it bodes well for 2018.
我們在上個季度實現了加速目標,這預示著 2018 年的好兆頭。
Oncology was particularly encouraging with a growth rate of about 19% across all our medicines.
腫瘤學尤其令人鼓舞,我們所有藥物的增長率約為 19%。
And of course, we had the impact of the new launches on in the last quarter.
當然,我們在上個季度受到了新發布的影響。
And those are slowly ramping up, in particular Imfinzi, but Tagrisso also is starting to accelerate on the back of our first-line data, which of course we don't promote, but some physicians, in particular in the U.S., are already starting to adopt in their daily practice.
那些正在慢慢增加,特別是 Imfinzi,但 Tagrisso 也開始在我們的一線數據的支持下加速,當然我們不提倡,但一些醫生,特別是在美國,已經開始在他們的日常實踐中採用。
CVMD also progressed very nicely.
CVMD 也取得了很好的進展。
We now have 2 blockbusters in our cardiovascular, Diabetes portfolio: Brilinta, which grew by 29%, really pleases me to see this product finally get to where I always thought it should be and there's more to come; and Farxiga, with a growth rate of 28% despite a very competitive marketplace.
現在,我們的心血管、糖尿病產品組合中有 2 個重磅炸彈:Brilinta,增長了 29%,我真的很高興看到這個產品終於達到了我一直認為它應該達到的水平,而且還會有更多;和 Farxiga,儘管市場競爭非常激烈,但增長率為 28%。
In Respiratory, we experienced some quarterly Symbicort improvement, starting to bottom out a little bit in some region and certainly grow very much in China.
在呼吸方面,我們經歷了一些季度的 Symbicort 改進,開始在一些地區觸底反彈,當然在中國增長非常快。
And the Fasenra launch is proceeding very well, very early days of course.
Fasenra 的發布進展順利,當然是在很早的時候。
We launched in November in the U.S., as you know, but so far, so good.
如您所知,我們於 11 月在美國推出,但到目前為止一切順利。
We're very satisfied with what we're seeing for this launch in the United States, including into January.
我們對此次在美國推出的產品非常滿意,包括 1 月份。
The Emerging Markets are clearly a nice story, in particular for China.
新興市場顯然是個好故事,尤其是對中國而言。
We experienced a growth rate of 8%, acceleration in Q4.
我們經歷了 8% 的增長率,並在第四季度加速。
Just like to remind you that, throughout the year, we were impacted negatively by divestments.
只想提醒您,全年我們都受到資產剝離的負面影響。
An example is the anesthetics divestment.
一個例子是麻醉劑撤資。
So the actual growth rate of those countries is higher than we report if you correct for this.
因此,如果您對此進行更正,那麼這些國家/地區的實際增長率高於我們報告的增長率。
China grew by 15%, also impacted negatively for 3 quarters by those divestments.
中國增長了 15%,這些資產撤資也對三個季度產生了負面影響。
In Q4, we experienced a growth rate of 30%.
第四季度,我們經歷了 30% 的增長率。
Just as a reminder: the market is growing by 7%, 8%, so the 30% growth rate is truly a very remarkable success.
提醒一下:市場正以 7%、8% 的速度增長,因此 30% 的增長率確實是一個非常了不起的成功。
And there's more to come in 2008 -- 2018, sorry.
2008 年還有更多——抱歉,2018 年。
I'm not suggesting a minute that the growth rate will be higher in Q4 but certainly more to come in term of products.
我並不是說第四季度的增長率會更高,但在產品方面肯定會更高。
As you know, we got reimbursement on the national drug reimbursement list for 5 new products.
大家知道,我們有5個新產品進入了國家藥品報銷目錄。
So that certainly will fuel our growth.
所以這肯定會推動我們的增長。
Tagrisso is doing very well.
塔格里索做得很好。
We are actually even seeing something in -- with Tagrisso in China that we would never have thought possible 5 years ago.
我們實際上什至在中國看到了一些東西——在中國的 Tagrisso 是我們 5 年前從未想過的。
We're seeing the product being reimbursed by some regional formularies.
我們看到一些地區處方藥正在報銷該產品。
And we would not have seen that 5 years ago simply because the cost was a hurdle.
5 年前我們不會看到這一點,僅僅是因為成本是一個障礙。
And things are changing, so really, we believe it has a great potential there.
事情正在發生變化,所以真的,我們相信它在那裡有很大的潛力。
Our core EPS is better than expected due essentially to product sales.
我們的核心每股收益好於預期主要是由於產品銷售。
There were some one-offs, sales true-ups and, of course, an improvement in our tax rate.
有一些一次性的、銷售調整,當然還有我們稅率的提高。
For 2018, we guided to a single-digit percentage increase in product sales.
2018 年,我們指導產品銷售額實現個位數百分比增長。
Got to remember, in 2008, we have the last portion of patent expiries hitting Japan and Europe.
必須記住,在 2008 年,我們有最後一部分專利到期衝擊了日本和歐洲。
This often has been forgotten.
這常常被遺忘。
The patent expired in Europe for Crestor later than the U.S., and therefore, there's still an impact in that region as well as in Japan.
Crestor 的專利在歐洲的到期時間晚於美國,因此,在該地區和日本仍有影響。
So just as a reminder, make sure you consider this as you do your forecast for this year.
因此,提醒一下,請確保在對今年進行預測時考慮到這一點。
By the end of this year, we'll be done with patent expiries.
到今年年底,我們將完成專利到期。
And we should really see the full swing, the full impact of those launches.
我們真的應該看到全面展開,這些發射的全部影響。
They will kick in, in 2019 in Europe.
他們將於 2019 年在歐洲開始。
They already started to kick in, in the U.S. in 2018, so by 2019, really, we are out of the woods as it relates to patent expiries.
他們已經在 2018 年在美國開始實施,所以到 2019 年,我們真的已經走出困境,因為它與專利到期有關。
We guided a core EPS of $3.30 to $3.50.
我們指導的核心每股收益為 3.30 美元至 3.50 美元。
This is to fully support the launch.
這是為了全力支持發射。
Importantly, we actually achieved in 2017 really good success beyond our financial results and the products of our pipeline.
重要的是,我們實際上在 2017 年取得了超越財務業績和管道產品的真正成功。
We were ranked 34 in the Corporate Knights' 14th annual Global 100 list of the most sustainable companies in the world.
我們在 Corporate Knights 第 14 屆年度全球最具可持續性公司 100 強榜單中排名第 34 位。
And everybody at AZ is very proud of this achievement that was on the back of a lot of good work by many people across the company.
AZ 的每個人都為這一成就感到非常自豪,這是在全公司許多人的大量出色工作的支持下取得的。
And we were identified as a high -- as a "biggest achiever" for 3 -- 300% increase in renewable electricity in a single year, so really very good result.
我們被認為是 3 年內可再生電力增長 300% 的“最大成就者”,這確實是非常好的結果。
If you turn to Slide 6. These are the highlights in term of the news flow.
如果您轉到幻燈片 6。這些是新聞流方面的亮點。
We had very rich news flow in the last part of the year.
今年下半年我們有非常豐富的新聞流。
As you can see here in particular, Lynparza received a U.S. approval in breast cancer, which is really a major milestone demonstrating the benefit of PARP inhibition outside of ovarian cancer.
正如您在這里特別看到的那樣,Lynparza 獲得了美國對乳腺癌的批准,這確實是一個重要的里程碑,證明了 PARP 抑制在卵巢癌之外的益處。
Within ovarian cancer, we received approval for Lynparza in Japan in the second-line setting.
在卵巢癌領域,我們在日本獲得了 Lynparza 的二線治療批准。
And this is an all-comer approval, so a very substantial opportunity for our Japanese organization.
這是一個所有人的認可,因此對我們的日本組織來說是一個非常重要的機會。
And also very pleased to announce that we received priority review in China.
並且非常高興地宣布我們在中國獲得了優先審評。
That's another thing that you would not have so possible in China 5 years ago.
這是另一件在 5 年前在中國不可能發生的事情。
The typical process was you have to wait for approval in another geography, and then you start developing in China and you basically launch several years after everybody else.
典型的過程是你必須在另一個地區等待批准,然後你開始在中國開發,基本上比其他人晚幾年推出。
This is changing.
這正在改變。
Tagrisso really led the way, and we're trying to achieve now the same ways with Lynparza.
Tagrisso 確實處於領先地位,我們現在正努力以與 Lynparza 相同的方式實現這一目標。
We presented, as you know, our Phase III data for FLAURA at the ESMO.
如您所知,我們在 ESMO 上展示了 FLAURA 的 III 期數據。
And as a result, we received break-through therapy designation for first-line use in the U.S. And this was followed by an acceptance of our submission in the U.S. with a priority review and also submission acceptances in both the EU and Japan, and those are proceeded.
結果,我們獲得了在美國一線使用的突破性療法指定。隨後我們在美國接受了我們提交的申請,並在歐盟和日本進行了優先審評,並接受了提交申請,以及那些進行。
In CVMD, we received some really, really good news for ZS-9.
在 CVMD,我們收到了一些關於 ZS-9 的非常非常好的消息。
The FDA accepted our regulatory resubmission.
FDA 接受了我們的監管重新提交。
And you've probably seen that in Europe the CHMP has now completed their inspection of the plant and through their satisfaction.
您可能已經看到,在歐洲,CHMP 現在已經完成了對工廠的檢查並表示滿意。
And then they reinstated their positive opinion, so hopefully, we get approval for those 2 medicines in the not-so-distant future -- for those medicines in those 2 region, I should say.
然後他們恢復了他們的積極意見,所以希望我們在不遠的將來獲得這兩種藥物的批准——我應該說,對於這兩個地區的那些藥物。
And finally, as I said a minute ago, we launched Fasenra.
最後,正如我剛才所說,我們推出了 Fasenra。
We got approval to launch Fasenra in the U.S. for severe and uncontrolled asthma.
我們獲准在美國推出 Fasenra 用於嚴重和不受控制的哮喘。
We also announced the positive top line results for the Phase III KRONOS trial recently, which looked at the triple-combination PT010 for patients with COPD.
我們最近還公佈了 III 期 KRONOS 試驗的正面頂線結果,該試驗研究了 COPD 患者的三聯組合 PT010。
And of course, as usual, Sean will cover the pipeline in more detail later.
當然,像往常一樣,肖恩稍後會更詳細地介紹管道。
So if you want to turn to Slide 7. I just want to highlight here the top part actually of the graph.
所以如果你想轉到幻燈片 7。我只想在這裡突出顯示圖表的頂部。
As you can see, we are -- in light gray, that shows you that we are kind of finished in term of the patent expiries in the United States.
正如你所看到的,我們是 - 淺灰色,這表明我們在美國的專利到期方面已經完成了。
The top part of the graph shows the patent losses -- the sales from products that have lost their patents in the U.S. The second part is the darker gray, reflects Europe and Japan, essentially.
圖表的頂部顯示了專利損失——在美國失去專利的產品的銷售額。第二部分是深灰色,主要反映了歐洲和日本。
And you can see here that they still -- we still have sales, and that explains why in 2018 we will see a decline here.
你可以在這裡看到他們仍然 - 我們仍然有銷售,這解釋了為什麼在 2018 年我們會在這裡看到下降。
The rest of the portfolio is growing nicely.
投資組合的其餘部分增長良好。
So if you move to Slide 8. As we said at the beginning of the year, 2017 was a defining year from a pipeline viewpoint because it's really the time when we started moving from pipeline delivery into commercial delivery.
所以如果你轉到幻燈片 8。正如我們在年初所說的那樣,從管道的角度來看,2017 年是決定性的一年,因為它確實是我們開始從管道交付轉向商業交付的時候。
And in 2018, we are in full swing, as far as commercial delivery.
而在 2018 年,我們正在如火如荼地進行商業交付。
We now have several products in launch mode.
我們現在有幾款產品處於發布模式。
And then essentially we really have commercial products.
然後基本上我們真的有商業產品。
Now we don't -- our story, if you will, is no longer purely a pipeline story, but it's a story of commercial delivery.
現在我們不——我們的故事,如果你願意的話,不再是純粹的管道故事,而是商業交付的故事。
On the right side, you see that we achieved many positive results.
在右側,您會看到我們取得了許多積極成果。
ZS-9 was a temporary setback, and hopefully, we should get approval soon, as I said.
ZS-9 是一個暫時的挫折,希望我們能像我說的那樣盡快獲得批准。
And there's of course, the MYSTIC setback.
當然,還有 MYSTIC 挫折。
We still have to -- PFS setback, I should say.
我們仍然必須—— PFS 挫折,我應該說。
We're still waiting for the overall survival results in the first half of this year.
我們仍在等待今年上半年的總體生存結果。
And I will let Dave and Sean cover the rest of the Oncology news in more detail.
我會讓戴夫和肖恩更詳細地報導其餘的腫瘤學新聞。
Now this, on this chart, you see essentially the sort of most important event, but if you look at the totality of the events that we experienced in 2017, there were 43 events, whether they were clinical readouts or regulatory approvals in various geographies.
現在,在這張圖表上,你基本上可以看到最重要的事件,但如果你看看我們在 2017 年經歷的事件的總數,就會發現有 43 起事件,無論是臨床讀數還是各個地區的監管批准。
Out of 43, 40 were positive.
43 人中有 40 人呈陽性。
We had 3 setbacks: (inaudible), ZS-9 and MYSTIC.
我們遇到了 3 個挫折:(聽不清)、ZS-9 和 MYSTIC。
So it really gives you a sense of the sheer scale of the pipeline progression we've experienced in 2017.
所以它真的讓你感受到我們在 2017 年經歷的管道進展的規模。
And the great work within the organization and Sean's leadership has been doing to deliver all of this.
組織內部的出色工作和 Sean 的領導層一直在努力實現這一切。
And there's more to come in 2018.
2018 年還會有更多。
We expect more or less the same volume of activity.
我們預計活動量大致相同。
And in fact, January was in itself a tremendous month in term of what you might call (inaudible) the productivity with several bright news there.
事實上,就您可能稱之為(聽不清)的生產力而言,1 月本身就是一個巨大的月份,那裡有幾個好消息。
So if we move to Slide 9. This shows you that we are definitely committed to returning the company to growth.
因此,如果我們轉到幻燈片 9。這表明我們絕對致力於讓公司恢復增長。
As a not-so-exciting reminder, we've had no growth since 2010 as we went through all those patent expiries.
作為一個不那麼令人興奮的提醒,自 2010 年以來我們經歷了所有這些專利到期後就沒有增長。
And I don't need to tell you this.
我不需要告訴你這個。
You know that, but it's certainly a reminder of the kind of transition we've gone through and the headwinds we've been experiencing for all these years.
你知道這一點,但這肯定會提醒我們這些年來我們經歷的那種轉變以及我們一直在經歷的逆風。
For the first time, in Q4, we experienced growth, not a lot of growth but certainly growth.
第一次,在第四季度,我們經歷了增長,增長不是很多,但肯定是增長。
And it's clearly a turning point for us.
這對我們來說顯然是一個轉折點。
As we look ahead, we have many positive opportunities that will drive our growth.
展望未來,我們有許多積極的機會來推動我們的發展。
Some of those are listed here, as you can see: Fasenra, of course; Farxiga; Brilinta.
如您所見,此處列出了其中一些:當然是 Fasenra;法西加;布里林塔。
The DECLARE trial for Farxiga will be a very substantial opportunity.
Farxiga 的 DECLARE 試驗將是一個非常重要的機會。
There's more coming for Tagrisso first line.
Tagrisso 第一線還有更多產品。
As soon as we get approval, we can start promoting the indication.
一旦我們獲得批准,我們就可以開始推廣該適應症。
Lynparza, Imfinzi, so as you can see here, quite a lot.
Lynparza、Imfinzi,正如你在這裡看到的,很多。
Still as I said earlier, a negative which is still a big negative, for Crestor in Europe and Japan.
正如我之前所說,對於歐洲和日本的 Crestor 來說,負面影響仍然是一個很大的負面影響。
That is slowing us down, but overall the -- our expectation for 2018 is that the positive should offset -- more than offset the negative.
這讓我們放慢了腳步,但總的來說——我們對 2018 年的預期是積極因素應該抵消——超過消極因素。
And we expect low single-digit growth rate in product sales.
我們預計產品銷售的低個位數增長率。
So with this, I'll now hand over to Mark, who's going to take you through our product sales and our growth platforms.
因此,現在我將交給馬克,他將帶您了解我們的產品銷售和增長平台。
Mark Mallon - EVP-Global Product & Portfolio Strategy, Medical Affairs, Corporate Affairs & International West
Mark Mallon - EVP-Global Product & Portfolio Strategy, Medical Affairs, Corporate Affairs & International West
Thanks, Pascal.
謝謝,帕斯卡。
And welcome, everybody.
歡迎大家。
I'm pleased to be here again to give you an update on our performance of our growth platforms.
我很高興再次來到這裡,向您介紹我們增長平台的最新表現。
So we'll start with our -- we'll go to Slide #12 (sic) [#11].
所以我們將從我們的 - 我們將轉到幻燈片 #12(原文如此)[#11]。
Great, thank you.
太好了謝謝。
Today, I'll cover the growth platforms, except New Oncology, which will be covered by our Head of Oncology Business Unit, Dave Fredrickson.
今天,我將介紹除 New Oncology 以外的增長平台,新腫瘤學將由我們的腫瘤業務部門負責人 Dave Fredrickson 負責。
The growth platforms delivered overall growth in the year of 6% with the strong acceleration during Q4 driven by continued volume growth; and true-ups, favorable true-ups, for -- in the U.S. for Respiratory.
在銷量持續增長的推動下,增長平台在第四季度實現了 6% 的整體增長;和調整,有利的調整,在美國用於呼吸系統。
Combined revenue from our growth platforms represented over 3/4 of our business product sales.
來自我們增長平台的合併收入占我們業務產品銷售額的 3/4 以上。
And also, we saw good momentum, as Pascal mentioned, in Emerging Markets but also in New CVMD and in New Oncology.
而且,正如 Pascal 提到的,我們在新興市場以及 New CVMD 和 New Oncology 中看到了良好的勢頭。
Turn to Slide 12, please.
請轉到幻燈片 12。
Now as we're going forward this year and as we increase our focus on commercial execution, we're going to start to share growth from our main therapeutic areas in this new format.
現在,隨著我們今年的前進,隨著我們更加關注商業執行,我們將開始以這種新形式分享我們主要治療領域的增長。
Basically, we will look at the whole of Oncology as a growth platform in itself, along with New CVMD, Respiratory and Emerging Markets.
基本上,我們會將整個腫瘤學本身視為一個增長平台,以及新 CVMD、呼吸和新興市場。
Next slide, please.
請換下一張幻燈片。
So thinking of Emerging Markets.
所以想到新興市場。
Emerging market growth continues to be in line with the long-term performance target of mid- to high single-digit growth in product sales with 8% sales growth for the year.
新興市場的增長繼續符合產品銷售額中高個位數增長的長期業績目標,全年銷售額增長 8%。
And as Pascal highlighted, China had a particularly strong year with excellent results in the fourth quarter, 30% growth.
正如 Pascal 強調的那樣,中國在第四季度取得了特別強勁的業績,增長了 30%。
And that contributed to an overall growth in the year of 15%.
這促成了今年 15% 的整體增長。
In -- also importantly in Emerging Markets, the growth was driven by our core growth platforms, our core therapeutic areas, which all delivered double-digit growth across Emerging Markets.
在——同樣重要的是在新興市場,增長是由我們的核心增長平台、我們的核心治療領域推動的,它們在整個新興市場都實現了兩位數的增長。
Please turn to Slide 14.
請轉到幻燈片 14。
In 2017, Emerging Markets performance was significantly impacted by divestments, so therefore, the underlying performance in China and Emerging Markets was actually even stronger than was reported.
2017 年,新興市場的表現受到撤資的顯著影響,因此,中國和新興市場的基本表現實際上比報導的還要強勁。
Excluding the effects of divestment, China demonstrated 18% and 22% growth in 2016 and 2017, and x China growth would be 7% and 10%.
剔除撤資的影響,中國在 2016 年和 2017 年分別增長了 18% 和 22%,x 中國增長將分別為 7% 和 10%。
It's also worth to note that the growth in China in the fourth quarter was absolutely driven by durable demands growth as sales were not impacted by inventory movements.
還值得注意的是,第四季度中國的增長完全是由耐用需求增長推動的,因為銷售不受庫存變動的影響。
And you can see that clearly on the China inventory chart at the right-hand side -- or the left-hand side of the page.
您可以在右側或頁面左側的中國庫存圖表上清楚地看到這一點。
So slide -- turn to Slide 15, please.
幻燈片——請轉到幻燈片 15。
Respiratory sales continued to see challenges in the year with an overall sales decline of 1%.
呼吸系統銷售額在這一年繼續面臨挑戰,整體銷售額下降了 1%。
Symbicort product sales were down by 6% in the year with the flat quarter partly driven by favorable sales true-up adjustment in the U.S., as I mentioned but also certainly by overall continued increase in volume.
Symbicort 產品銷售額在這一年下降了 6%,季度持平部分是由於美國有利的銷售調整,正如我提到的,但也肯定是由於整體銷量持續增長。
In the U.S. and Europe, Symbicort sales declined by 12% and 10%, respectively.
在美國和歐洲,信必可的銷售額分別下降了 12% 和 10%。
Importantly, in the U.S. NBRx, new-to-brand prescriptions, has been growing actually for Symbicort since September.
重要的是,自 9 月以來,美國 NBRx 的新品牌處方實際上一直在增長。
And this was driven by an increase in share of voice, by the expanded exacerbations label -- COPD exacerbations, and the launch of a new campaign.
這是由於聲音份額的增加、惡化標籤的擴大——慢性阻塞性肺病惡化以及新活動的啟動。
So very encouraged by Symbicort performance in the fourth quarter.
Symbicort 在第四季度的表現非常鼓舞人心。
Symbicort continued to grow in Emerging Markets and delivered 10% growth this year.
Symbicort 在新興市場繼續增長,今年實現了 10% 的增長。
And Pulmicort also continued to demonstrate robust growth, up 12% in the year, driven by Emerging Markets with a fourth quarter performance of 26%.
在新興市場的推動下,Pulmicort 也繼續保持強勁增長,全年增長 12%,第四季度業績增長 26%。
And this was driven by underlying growth and also some seasonality.
這是由潛在增長和一些季節性因素推動的。
Please turn to Slide 16.
請轉到幻燈片 16。
As Pascal mentioned, staying in Respiratory, we're pleased to announce the approval on in the -- Fasenra in the U.S. and the launch in the fourth quarter.
正如 Pascal 提到的,留在呼吸系統,我們很高興地宣佈在美國批准 Fasenra 並在第四季度推出。
And actually, we now also announced approvals in Europe and Japan in January.
實際上,我們現在還在 1 月份宣布了在歐洲和日本的批准。
And this is for patients with severe asthma, as you know.
如您所知,這是針對嚴重哮喘患者的。
We launched Fasenra at the end of last year.
我們在去年年底推出了 Fasenra。
And as Pascal also highlighted, the feedback -- initial feedback from the market from physicians, payers and patients has all been positive and consistent with Fasenra's highly competitive clinical profile.
正如 Pascal 還強調的那樣,反饋——來自醫生、付款人和患者的市場初步反饋都是積極的,並且與 Fasenra 極具競爭力的臨床資料一致。
Next slide, please.
請換下一張幻燈片。
Moving to New CVMD.
移動到新 CVMD。
Sales were up 9% despite intense competition with fourth quarter growth of 21%; continued growth that was demonstrated across all regions, which was very exciting to see, and this is for Farxiga and Brilinta.
儘管競爭激烈,銷售額仍增長了 9%,第四季度增長了 21%;所有地區都表現出持續增長,這是非常令人興奮的,這適用於 Farxiga 和 Brilinta。
And both, as Pascal mentioned, achieved blockbuster status with more than $1 billion in sales.
正如帕斯卡所說,兩者都以超過 10 億美元的銷售額取得了轟動一時的地位。
Brilinta delivered 29% growth, which was particularly -- with particularly impressive performance in the U.S. of 46% growth in 2017.
Brilinta 實現了 29% 的增長,這尤其令人印象深刻,2017 年在美國的增長達到了 46%。
And Farxiga delivered 28% growth in the year and maintained a 41% volume market share globally; maintained, continued to -- leadership within the SGLT2 class.
Farxiga 在這一年實現了 28% 的增長,並保持了 41% 的全球銷量市場份額;保持並繼續——在 SGLT2 班級中處於領先地位。
In the U.S. we're excited also to have our innovative autoinjector Bydureon BCise launched.
在美國,我們也很高興推出創新型自動注射器 Bydureon BCise。
And again, we're seeing encouraging early uptake with the Bydureon BCise.
再一次,我們看到 Bydureon BCise 的早期採用令人鼓舞。
Next slide, please.
請換下一張幻燈片。
In Japan, we continue to grow, with product sales up 4%.
在日本,我們繼續增長,產品銷售額增長了 4%。
That's despite a declining Japanese market.
儘管日本市場正在下滑。
Growth was mainly driven by Forxiga, a new indication for Faslodex and Forxiga.
增長主要由 Forxiga 推動,這是 Faslodex 和 Forxiga 的新適應症。
We took -- I should say Tagrisso, a new indication for Faslodex and Forxiga.
我們採用了——我應該說 Tagrisso,這是 Faslodex 和 Forxiga 的新適應症。
We look forward to launches of our recently approved products Lynparza and Fasenra in Japan, which will add to our opportunity there significantly.
我們期待在日本推出我們最近批准的產品 Lynparza 和 Fasenra,這將大大增加我們在日本的機會。
And actually the performance of our team in Japan is really outstanding.
實際上我們在日本的團隊表現非常出色。
Symbicort, Nexium, Farxiga and Tagrisso are all #1 in terms of volume market share in Japan.
Symbicort、Nexium、Farxiga 和 Tagrisso 在日本的銷量市場份額方面均排名第一。
And so it's great work by our local team there.
因此,我們當地團隊的工作非常出色。
Crestor did see a first -- their first generic competition in Q3 with multiple generics launching in the fourth quarter, so we're now seeing an erosion rate comparable to other major products in Japan when they face generic competition.
Crestor 確實看到了第一個——他們在第三季度的第一個仿製藥競爭,在第四季度推出了多個仿製藥,所以我們現在看到侵蝕率與日本其他主要產品在面臨仿製藥競爭時相當。
And we do anticipate this effect to continue throughout 2018.
我們預計這種影響將持續到 2018 年。
We've had continued great success with Tagrisso, where we've fully saturated the addressable second-line market with a 90% market share in the second line.
我們在 Tagrisso 方面繼續取得巨大成功,我們已經完全飽和了可尋址的二線市場,在二線市場佔有 90% 的份額。
And so really outstanding performance by the team in Japan.
日本隊的表現非常出色。
And on that note, it's a great pleasure to hand over to Dave to take you through the oncology growth platform.
在這一點上,很高興交給 Dave 帶您完成腫瘤學增長平台。
We can go ahead and move to Slide 19.
我們可以繼續並轉到幻燈片 19。
Thanks, everyone.
謝謝大家。
David Fredrickson - Executive VP & Global Head Oncology Business Unit
David Fredrickson - Executive VP & Global Head Oncology Business Unit
Thanks, Mark.
謝謝,馬克。
Good afternoon, everyone.
大家下午好。
So now as we turn to Oncology.
所以現在我們轉向腫瘤學。
We are really pleased to announce $4 billion in total product sales in 2017.
我們非常高興地宣布 2017 年產品總銷售額為 40 億美元。
So this now represents 20% of total AstraZeneca product sales, and that's growth of 19% year-over-year 2017 versus 2016.
因此,這現在佔阿斯利康產品總銷售額的 20%,與 2016 年相比,2017 年同比增長 19%。
I think really, importantly, within this we see now that 4 of the 6 new medicines that is part of our ambition to launch by 2020 have now been delivered.
我認為非常重要的是,我們現在看到,我們計劃在 2020 年推出的 6 種新藥中有 4 種已經交付。
And we look across these, and I'll talk about it in greater detail, but we see truly global launches with both Lynparza and Tagrisso.
我們審視了這些,我將更詳細地討論它,但我們看到了 Lynparza 和 Tagrisso 真正的全球上市。
With Lynparza, the growth is accelerating as we see success within ovarian cancer, also combined with the new launch which will be a catalyst going forward within breast.
Lynparza 的增長正在加速,因為我們看到在卵巢癌治療中取得了成功,同時新的上市將成為乳腺癌治療的催化劑。
In Tagrisso we've seen success consistently across the second line as we prepare for first line.
在 Tagrisso,我們在準備一線時看到了二線的持續成功。
And then within the U.S., the success of Imfinzi and Calquence, we really look forward on building onto as we move into 2018.
然後在美國,Imfinzi 和 Calquence 的成功,我們真的很期待在我們進入 2018 年時再接再厲。
And those are catalysts for next year.
這些都是明年的催化劑。
New Oncology, within the $4 billion, delivered $1.3 billion, as Mark had mentioned previously, last year.
New Oncology 在這 40 億美元中,去年交付了 13 億美元,正如馬克之前提到的那樣。
And we look forward to that continuing strong growth in the next year.
我們期待明年繼續保持強勁增長。
If we could turn to the next slide, please.
請轉到下一張幻燈片。
So now focusing on Lynparza.
所以現在專注於 Lynparza。
I want to go through and talk about what has really been strong performance there as well.
我想通過並談談那裡真正強勁的表現。
For the quarter, globally, we saw $100 million in sales, which results in full year sales of $297 million with really very strong growth, as you can see on the slide, across all regions.
對於本季度,我們在全球範圍內實現了 1 億美元的銷售額,這導致全年銷售額達到 2.97 億美元,增長非常強勁,正如您在幻燈片中看到的那樣,在所有地區。
And it's underpinned by truly strong growth in the second half of the year within the U.S.
它得到了美國今年下半年真正強勁增長的支持。
What we saw from that is, once the handicap of the pill burden and also the narrower label were lifted with the SOLO-2 approval, that we really began to increase our competitiveness within the ovarian cancer space.
我們從中看到的是,一旦 SOLO-2 的批准解除了藥物負擔和更窄標籤的障礙,我們就真正開始提高我們在卵巢癌領域的競爭力。
And we see 74% growth within the quarter within the U.S. and sales of $141 million.
我們看到美國本季度增長了 74%,銷售額達到 1.41 億美元。
I think it is important to also note that the majority and in fact a significant majority of our sales in the fourth quarter in the U.S. were in ovarian cancer versus in other tumor types.
我認為還需要注意的是,我們第四季度在美國的大部分銷售額,實際上是絕大部分銷售額來自卵巢癌,而不是其他腫瘤類型。
We saw strong progress throughout the year within Europe with sales up 58% and the full year European sales of $130 million.
我們在歐洲全年取得了長足的進步,銷售額增長了 58%,全年歐洲銷售額達到 1.3 億美元。
BRCA testing rates have been moving nicely.
BRCA 測試率一直在很好地移動。
And it's boosted by all those additional launches that we've seen across several markets.
我們在多個市場看到的所有這些額外的發布都推動了它的發展。
Again as we mentioned before, Japan was just in January approved for the all-comers label in platinum-sensitive resistant.
同樣,正如我們之前提到的,日本僅在 1 月份批准了對鉑敏感耐藥的全能標籤。
We're certainly very pleased with this progress.
我們當然對這一進展感到非常高興。
We look forward to that being a catalyst going forward in 2018.
我們期待這成為 2018 年前進的催化劑。
And finally, I'm really pleased to say that our collaboration with Merck is going very well.
最後,我真的很高興地說,我們與默克的合作進展順利。
We see good integration both on the development side but also on the commercial side.
我們在開發方面和商業方面都看到了良好的整合。
Joint U.S. field forces are now in the field operating together, partnering and collaborating together.
美國聯合外勤部隊現在正在外地共同行動、合作和協作。
And that was in time for the breast cancer launch, and that was on purpose.
那是乳腺癌上市的時間,而且是故意的。
We'll continue to see the global Merck team come onboard throughout 2018 across major regions.
整個 2018 年,我們將繼續看到全球默克團隊在主要地區加入進來。
If we could turn to Slide 21, please.
請轉到幻燈片 21。
So moving on to lung cancer and specifically to take a look at Tagrisso and Imfinzi.
所以轉向肺癌,特別是看看 Tagrisso 和 Imfinzi。
First, starting with Tagrisso, very pleased to see that Tagrisso demonstrated continued growth quarter-on-quarter and now is at $955 million in sales for the year.
首先,從 Tagrisso 開始,很高興看到 Tagrisso 顯示出季度環比持續增長,目前全年銷售額為 9.55 億美元。
This is predominantly driven by second line and higher testing rates that we've seen across all of the markets that we're in.
這主要是由二線和更高的測試率推動的,我們在我們所處的所有市場中都看到了這一點。
We have seen in the U.S. 59% growth over the year, testing rates now over 70%.
我們在美國看到了 59% 的增長,測試率現在超過 70%。
And we see continued growth as we prepare for first line.
在我們為一線做準備時,我們看到了持續增長。
We also saw very strong growth in Europe, up 142% over the year.
我們在歐洲也看到了非常強勁的增長,全年增長了 142%。
The testing rates in Europe are somewhat below what we see within the U.S. I think that, that actually creates opportunity for a little bit of further growth within Europe.
歐洲的測試率略低於我們在美國看到的水平。我認為,這實際上為歐洲進一步增長創造了機會。
And that's something that we're working on.
這就是我們正在努力的事情。
The France testing rates are certainly on par with what we see within the United States.
法國的測試率肯定與我們在美國看到的不相上下。
In Japan, as Mark mentioned, testing rates are over 90%.
正如馬克所說,在日本,測試率超過 90%。
We see market share among those that are T790M positive also above 90%, so Japan has really probably hit about its theoretical max in terms of second line.
我們看到 T790M 陽性的市場份額也超過 90%,因此日本在二線方面確實可能達到其理論最大值。
And we're getting ready for first line within Japan.
我們正在為日本國內的第一線做好準備。
And then lastly, Pascal spoke about China and what we've had in terms of really an outstanding early penetration into that market.
最後,Pascal 談到了中國,以及我們在早期對該市場的真正出色滲透方面所擁有的。
Turning quickly to Imfinzi.
迅速轉向 Imfinzi。
We look forward to the regulatory decisions that are going to come on PACIFIC.
我們期待 PACIFIC 即將出台的監管決定。
In the meanwhile, we've been quite pleased to see that within bladder cancer, our labeled indication, we are now third in the market in terms of market share with low double-digit market share.
與此同時,我們很高興地看到,在我們標記的適應症膀胱癌中,我們現在在市場份額方面排名第三,市場份額低至兩位數。
And I think that speaks to the competitiveness of our field force.
我認為這說明了我們外勤人員的競爭力。
And we're in preparations and getting ready for launch for the Stage III unresectable launch that's coming up shortly.
我們正在為即將到來的第三階段不可切除的發射做準備和準備。
If you turn to Slide 22.
如果你翻到幻燈片 22。
So in summary, if you put together what you've heard from both Mark Mallon, Pascal and myself, we have now a pipeline transformation that is continuing to deliver.
所以總而言之,如果你把你從 Mark Mallon、Pascal 和我自己那裡聽到的東西放在一起,我們現在有一個正在繼續交付的管道轉型。
And we're now focused on commercial execution on a global scale.
我們現在專注於全球範圍內的商業執行。
The extensive portfolio across our 3 main therapy areas has the potential to deliver several blockbuster medicines.
我們 3 個主要治療領域的廣泛產品組合有可能提供多種重磅炸彈藥物。
And you see that we've got several global launches underway across each of the therapeutic areas: Oncology, CV metabolism and Respiratory.
你會看到我們在每個治療領域都進行了幾項全球發布:腫瘤學、心血管代謝和呼吸。
We remain committed to ensuring all eligible patients get access to our treatments as quickly as possible.
我們仍然致力於確保所有符合條件的患者盡快獲得我們的治療。
And with this, it's my pleasure to turn over to Marc Dunoyer to go through some of our financials.
有了這個,我很高興轉向 Marc Dunoyer 來審視我們的一些財務狀況。
Thank you.
謝謝你。
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
Thank you, Dave.
謝謝你,戴夫。
And hello, everyone.
大家好。
I'm going to spend the next few minutes to review the financial performance for 2017 and then move on to the guidance we provided this morning for the year 2018.
我將在接下來的幾分鐘內回顧 2017 年的財務業績,然後繼續討論我們今天上午提供的 2018 年的指導意見。
If you could please turn to Slide 24.
如果可以,請轉到幻燈片 24。
As usual, I'm going to start with the reported P&L before turning to the core numbers.
像往常一樣,在轉向核心數字之前,我將從報告的損益開始。
As Pascal mentioned earlier, the total revenue declined by 2% in the year with product sales impacted by Crestor and Seroquel XR losses of exclusivity in the United States.
正如 Pascal 之前提到的,由於 Crestor 和 Seroquel XR 在美國失去獨占權,產品銷售受到影響,今年總收入下降了 2%。
Product sales, however, grew by 3% in the quarter, which included favorable true-up adjustment related to the first 9 months of 2017.
然而,本季度產品銷售額增長了 3%,其中包括與 2017 年前 9 個月相關的有利調整。
Encouraging progress, however, was made right across all therapy areas and in regions such as Emerging Markets.
然而,在所有治療領域和新興市場等地區都取得了令人鼓舞的進展。
Externalization revenue grew by 38% in the year with income from the collaboration with Merck of $1.2 billion making just over half of the total.
外部化收入在這一年增長了 38%,其中來自與默克公司合作的收入為 12 億美元,佔總收入的一半多一點。
The reported tax rate of minus 29% in the year reflected a favorable net adjustment of $617 million to defer taxes driven by the recently reduced U.S. federal income tax rate and nontaxable fair value adjustment relating to contingent consideration on business combinations.
今年報告的稅率為負 29%,反映了 6.17 億美元的有利淨調整,以遞延稅款,這是由最近降低的美國聯邦所得稅率和與企業合併的或有對價相關的非應稅公允價值調整所推動的。
Please turn to Slide 25.
請轉到幻燈片 25。
Turning now to the core P&L.
現在轉向核心損益。
Our gross margin ratio for the year fell by 1 percentage point to 81.2% driven primarily by product mix effects, including the decline of [sets] of medicine where we have lost exclusivity as well as a ramp-up of manufacturing capacity for new medicines.
我們今年的毛利率下降了 1 個百分點,至 81.2%,這主要是由於產品組合效應,包括我們失去獨家經營權的 [套] 藥品的減少以及新藥製造能力的提高。
The core gross margin ratio is also increasingly impacted by agreements with both Merck and Circassia.
核心毛利率也越來越受到與默克和 Circassia 的協議的影響。
To remind you: we book all Lynparza and Tudorza product sales and reflect the product profit share within cost of sales.
提醒您:我們計入所有 Lynparza 和 Tudorza 產品的銷售額,並在銷售成本中反映產品利潤份額。
It is useful to remember that when you're modeling your performance -- our performance and anticipate a further decline in our gross margin ratio versus 2017 for 2018.
記住當你對你的表現進行建模時——我們的表現和預期我們的毛利率比 2017 年 2018 年進一步下降是有用的。
Core R&D and SG&A costs each reduced by 3% in the year.
核心研發和 SG&A 成本在這一年各減少了 3%。
This reduction reflected our focus on cost discipline.
這種減少反映了我們對成本紀律的關注。
We did, however, see an uplift in core SG&A cost in the second half driven by some specific factors, which I'll talk about in a moment.
然而,我們確實看到下半年核心 SG&A 成本在一些特定因素的推動下有所上升,我稍後會談到。
Core operating -- other operating income increased by 14% in the year, a result of the level of disposal activity.
核心運營——其他運營收入在年內增長了 14%,這是處置活動水平的結果。
The core tax rate in the year-to-date was 14%, slightly lower than the range I indicated previously.
今年迄今的核心稅率為 14%,略低於我之前指出的範圍。
The rate was not impacted by U.S. tax reform, the adjustment for which were reflected only in the reported tax rate.
該稅率不受美國稅制改革的影響,其調整僅反映在報告的稅率中。
In the fourth quarter, our core tax rate benefited from the impact of U.K. Patent Box profits, true-up on tax returns and positive development in relation to a number of historic tax liabilities for which we had previously provided.
在第四季度,我們的核心稅率受益於英國專利盒利潤的影響、納稅申報表的調整以及與我們之前提供的一些歷史稅收負債相關的積極發展。
These reflected the variability that can be expected now and again on tax matters.
這些反映了在稅收問題上可以預期的不時變化。
For 2018, I envisage a core tax rate of 16% to 20%.
對於 2018 年,我預計核心稅率為 16% 至 20%。
Please turn to Slide 26.
請轉到幻燈片 26。
Looking at external revenue in more detail, I want to turn to the contribution of ongoing externalization revenue, which includes royalties, option payments, milestone payments and profit sharing.
更詳細地看一下外部收入,我想談談正在進行的外部化收入的貢獻,其中包括特許權使用費、期權付款、里程碑付款和利潤分享。
In 2017, this amounted to $821 million and was 35% of the total externals revenue.
2017 年,這達到 8.21 億美元,佔外部總收入的 35%。
In 2016, the ratio was 21%.
2016 年這一比例為 21%。
Over time, we expect to see this ratio possibly rising further.
隨著時間的推移,我們預計這一比率可能會進一步上升。
The collaboration with Merck is expected to provide a significant amount of income in the years to come.
預計與默克公司的合作將在未來幾年帶來可觀的收入。
We recognize about $1.2 billion in external revenue from Merck in the year and a further cash inflow of $600 million deferred against future R&D investment.
我們確認了默克公司當年約 12 億美元的外部收入,以及未來研發投資遞延的 6 億美元現金流入。
As mentioned previously, the agreement also included payments by Merck of $750 million for certain license option over 2017 to 2019 and up to $6.15 billion contingent upon successful achievement of approval and sales milestone for both monotherapy and combinations; we received the first option payment of $250 million.
如前所述,該協議還包括默克公司在 2017 年至 2019 年期間為某些許可選項支付的 7.5 億美元以及高達 61.5 億美元的費用,這取決於單一療法和聯合療法是否成功實現批准和銷售里程碑;我們收到了 2.5 億美元的第一筆期權付款。
To conclude this slide, I want to reiterate that we remain committed to focusing on appropriate, cash-generating and value-accretive deals given the productivity of our pipeline.
在結束這張幻燈片時,我想重申,鑑於我們管道的生產力,我們仍然致力於專注於適當的、產生現金和增值的交易。
We're also committed to the constant management of our portfolio disposal and to increasing the focus on our 3 main therapy areas over time.
我們還致力於持續管理我們的投資組合處置,並隨著時間的推移增加對我們 3 個主要治療領域的關注。
Please turn to Slide 27.
請轉到幻燈片 27。
It's important to illustrate the progress we have made last year in reducing our operating cost base in line with the commitments I gave 12 months ago.
重要的是要說明我們去年在根據我 12 個月前做出的承諾降低運營成本基礎方面取得的進展。
Core R&D cost declined by 3% with Oncology continuing to occupy the largest part of investment at 44% of the total.
核心研發成本下降了 3%,其中腫瘤學繼續佔據最大的投資份額,佔總投資的 44%。
CVMD and Respiratory again enjoyed around 1/4 of the R&D budget each with only a nominal level of funding allocated outside the 3 main therapy areas.
CVMD 和呼吸再次享有約 1/4 的研發預算,每個僅在 3 個主要治療領域之外分配了名義水平的資金。
In 2018, core R&D costs are anticipated to be in the range of a low single-digit percentage decline to stable, including the favorable impact on development cost from the collaboration with Merck.
2018 年,核心研發成本預計將處於低個位數百分比下降至穩定的範圍內,包括與默克公司合作對開發成本的有利影響。
I did say back in July that you may see some rise in core SG&A cost.
我在 7 月份確實說過,您可能會看到核心 SG&A 成本有所上升。
That is exactly what you saw in the second half given investment in our launch programs.
鑑於對我們的啟動計劃的投資,這正是您在下半年看到的情況。
We continue to make encouraging progress in reducing our underlying SG&A cost base, particularly within our infrastructure and [admin] functions.
我們在降低基礎 SG&A 成本基礎方面繼續取得令人鼓舞的進展,特別是在我們的基礎設施和 [管理] 職能方面。
In 2018, core SG&A cost are expected to increase by low to mid-single-digit percentage.
2018 年,核心 SG&A 成本預計將以中低個位數百分比增長。
Please turn to Slide 28.
請轉到幻燈片 28。
Cash generation remains a focus for the entire management team.
現金產生仍然是整個管理團隊關注的焦點。
As you can see on either side of the chart, we improved our net cash inflows before financing activities by $1.1 billion in the year.
正如您在圖表兩側看到的那樣,我們在這一年中將融資活動前的淨現金流量增加了 11 億美元。
The reduction in cash from operation reflected the impact on the movement in working capital that was driven by factoring levels in 2016.
運營現金減少反映了 2016 年保理水平對營運資金變動的影響。
The lower level of purchase of intangible assets, however, reflected the acquisition of Takeda's respiratory portfolio in 2016, while upfront payment on business combinations were $1.1 billion lower in '17 given the upfront Acerta investment in 2016.
然而,較低水平的無形資產購買反映了武田在 2016 年對呼吸產品組合的收購,而鑑於 2016 年 Acerta 的前期投資,17 年企業合併的預付款減少了 11 億美元。
We know we have more work to do to drive our underlying cash flow.
我們知道我們還有更多工作要做,以推動我們的基礎現金流。
We do anticipate growth in product sales and expect a reduction in restructuring cost to accompany our focus on cost discipline.
我們確實預計產品銷售會增長,並預計重組成本會隨著我們對成本紀律的關注而降低。
Please turn to Slide 29.
請轉到幻燈片 29。
I'd like to conclude with our 2018 guidance, which is on product sales and core EPS.
我想以我們 2018 年的產品銷售和核心 EPS 指南作為結尾。
We anticipate low single-digit percentage growth in product sales in 2018 at constant exchange rate.
按固定匯率計算,我們預計 2018 年產品銷售額將實現低個位數百分比增長。
This is weighted toward the second half, reflecting the impact of generic competition to Crestor that -- as Pascal mentioned earlier.
這是對下半年的加權,反映了仿製藥競爭對 Crestor 的影響——正如 Pascal 前面提到的那樣。
In 2018, anticipate the sum of external revenue and other income to be less than that of 2017.
預計 2018 年對外營業收入及其他收入之和將低於 2017 年。
We also anticipate a core EPS of $3.30 to $3.50 at constant exchange rates.
我們還預計以固定匯率計算的核心每股收益為 3.30 美元至 3.50 美元。
Within the financial performance, we're already starting to see as well the success of our pipeline and commercial execution.
在財務業績中,我們已經開始看到我們的管道和商業執行的成功。
I'm confident in our ability to deliver against what are unchanged and consistent capital allocation priorities summarized on the right of this panel.
我相信我們有能力兌現本小組右側總結的不變和一致的資本分配優先事項。
With that, I will hand over to Sean.
有了這個,我將交給肖恩。
Thank you.
謝謝你。
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Thank you, Marc.
謝謝你,馬克。
And thank you, everybody, for taking time to join us today.
感謝大家今天抽出時間加入我們。
I'd like to now run through the late-stage pipeline events since the last results announcement and the highlights of recent data presentations, then I'll finish with a look at our upcoming news flow.
我現在想回顧一下自上次結果公佈以來的後期管道事件和最近數據演示的亮點,然後我將看看我們即將發布的新聞流。
Please turn to Slide 31.
請轉到幻燈片 31。
We delivered more good progress in the quarter in each therapy area.
我們在每個治療領域在本季度取得了更好的進展。
In Oncology, Faslodex received approval in the U.S. and EU for the combination with CDK4/6 inhibitors in breast cancer.
在腫瘤學領域,Faslodex 在美國和歐盟獲得了與 CDK4/6 抑製劑聯合治療乳腺癌的批准。
Lynparza was approved in second-line ovarian cancer in Japan, the first PARP inhibitor to be approved in Japan.
Lynparza 在日本獲批用於卵巢癌二線治療,是日本首個獲批的 PARP 抑製劑。
And as Pascal mentioned, we were also granted priority review for Lynparza in China.
正如 Pascal 提到的,我們還獲得了 Lynparza 在中國的優先審評。
In the U.S. we received Lynparza approval for the treatment of germ line BRCA-mutated metastatic breast cancer from the OlympiAD data, making Lynparza the first PARP inhibitor to be approved beyond the treatment of ovarian cancer.
在美國,我們從 OlympiAD 數據中獲得了 Lynparza 批准用於治療種系 BRCA 突變的轉移性乳腺癌,這使 Lynparza 成為第一個被批准用於治療卵巢癌以外的 PARP 抑製劑。
Tagrisso received Breakthrough Therapy designation in the United States after meeting its PFS primary endpoint in the first-line FLAURA trial.
Tagrisso 在一線 FLAURA 試驗中達到其 PFS 主要終點後,在美國獲得了突破性治療指定。
And we're awaiting regulatory decisions for first line in the U.S., EU and Japan.
我們正在等待美國、歐盟和日本對一線藥物的監管決定。
In CVMD, we received EU approval for the combination of Bydureon and insulin in type 2 diabetes based on the results of the DURATION-7 trial.
在 CVMD 中,我們根據 DURATION-7 試驗的結果獲得了歐盟對 Bydureon 和胰島素聯合治療 2 型糖尿病的批准。
As Pascal explained earlier, we also had encouraging news for ZS-9 in both the U.S. and the EU.
正如 Pascal 之前解釋的那樣,我們在美國和歐盟也有關於 ZS-9 的令人鼓舞的消息。
For roxadustat, our partner FibroGen received priority review status in China for the treatment of anemia.
對於 roxadustat,我們的合作夥伴 FibroGen 在中國獲得了治療貧血的優先審查地位。
In Respiratory, Symbicort received U.S. approval for COPD exacerbations, while Fasenra gained approval in the U.S., EU and Japan.
在呼吸系統方面,Symbicort 獲得了美國批准用於 COPD 急性加重,而 Fasenra 獲得了美國、歐盟和日本的批准。
The KRONOS trial met 8 of 9 primary endpoints.
KRONOS 試驗達到了 9 個主要終點中的 8 個。
Lastly, based on strong Phase II trial results for tezepelumab, we initiated a new Phase III trial, NAVIGATOR, in patients with severe uncontrolled asthma.
最後,基於 tezepelumab 強大的 II 期試驗結果,我們在嚴重未控制的哮喘患者中啟動了一項新的 III 期試驗 NAVIGATOR。
Turn now to Slide 32.
現在轉到幻燈片 32。
Turning to lung cancer specifically.
特別是肺癌。
We're rapidly moving forward with regulatory submissions around the world from strong FLAURA and PACIFIC data.
我們正在根據強大的 FLAURA 和 PACIFIC 數據在全球範圍內快速推進監管提交。
Tagrisso was submitted in the U.S., EU and Japan last year for first-line EGFR-mutated nonsmall cell lung cancer.
Tagrisso 去年在美國、歐盟和日本提交,用於一線 EGFR 突變的非小細胞肺癌。
We anticipate a regulatory decision in the first half of this year in the U.S., where it's under priority review.
我們預計美國將在今年上半年做出監管決定,該決定正在接受優先審查。
We anticipate decisions in the EU and Japan in the second half of the year.
我們預計歐盟和日本將在今年下半年做出決定。
Turning to Imfinzi.
轉向 Imfinzi。
We saw 8 regulatory submissions by the end of 2017 based on the PACIFIC data for the treatment of Stage III unresectable nonsmall cell lung cancer.
到 2017 年底,我們看到了 8 份基於 PACIFIC 數據的監管提交,用於治療 III 期不可切除的非小細胞肺癌。
We anticipate very similar time lines to that of Tagrisso in the U.S., the EU and Japan.
我們預計美國、歐盟和日本的 Tagrisso 的時間表非常相似。
Next slide, please.
請換下一張幻燈片。
Looking now at CVMD, we anticipate 2 key Phase III readouts in 2018.
現在看看 CVMD,我們預計 2018 年將有 2 個關鍵的 III 期讀數。
Farxiga's DECLARE trial remains on track to read out in the second half of the year.
Farxiga 的 DECLARE 試驗仍有望在今年下半年宣讀。
Roxadustat -- for roxadustat, we continue to anticipate regulatory submission in the second half of the year for this potentially first-in-class treatment for anemia.
Roxadustat——對於 roxadustat,我們繼續預計在今年下半年提交監管申請,用於治療這種潛在的一流貧血治療藥物。
Now turning to Slide 34.
現在轉到幻燈片 34。
Starting with PT010, our ICS/LAMA/LABA combination therapy in a fixed dose in our Aerosphere Delivery Technology in a pressurized metered-dose inhaler, in the KRONOS Phase III trial, PT010 demonstrated significant improvement in 6 out of 7 lung function primary endpoints compared with dual-combination therapies in patients with moderate to severe COPD.
從 PT010 開始,我們的 ICS/LAMA/LABA 聯合療法在加壓計量吸入器中採用我們的 Aerosphere Delivery Technology 進行固定劑量治療,在 KRONOS III 期試驗中,PT010 在 7 個肺功能主要終點中的 6 個方面表現出顯著改善在中度至重度 COPD 患者中採用雙重聯合療法。
In total, 8 of 9 primary endpoints in the KRONOS trial were met, including 2 noninferiority endpoints that were required to qualify PT009 as a viable comparator.
總的來說,KRONOS 試驗的 9 個主要終點中有 8 個得到滿足,包括 2 個非劣效性終點,這些終點是使 PT009 成為一個可行的比較器所必需的。
We look forward to the ETHOS exacerbation trial results in 2019, which will further characterize the role of this potential new treatment for patients with COPD.
我們期待 2019 年的 ETHOS 加重試驗結果,這將進一步表徵這種潛在的新療法對 COPD 患者的作用。
We believe our biologics portfolio for severe asthma is emerging as one of the strongest in the industry.
我們相信,我們針對嚴重哮喘的生物製劑組合正在成為業內最強大的組合之一。
Turning to tezepelumab, a first-in-class potential new medicine that blocks TSLP.
轉向 tezepelumab,一種阻斷 TSLP 的 first-in-class 潛在新藥。
A recent Phase IIb clinical trial called PATHWAY evaluated tezepelumab in a broad population of severe asthma patients.
最近一項名為 PATHWAY 的 IIb 期臨床試驗在大量嚴重哮喘患者中評估了 tezepelumab。
The results were published in the New England Journal of Medicine and presented as a late-breaking abstract at ERS.
結果發表在《新英格蘭醫學雜誌》上,並在 ERS 上作為最新摘要發表。
Finally, while Fasenra is already approved in severe uncontrolled asthma, our VOYAGER program is evaluating the efficacy and safety in severe COPD.
最後,雖然 Fasenra 已獲准用於嚴重未控制的哮喘,但我們的 VOYAGER 計劃正在評估嚴重 COPD 的療效和安全性。
And we anticipate data in the second half of 2018.
我們預計 2018 年下半年的數據。
We believe Fasenra has the potential to be the best-in-class medicine because it's an anti-eosinophil monoclonal antibody that targets the IL-5 receptor, thereby inducing direct and near-complete depletion of eosinophils via antibody-dependent cell-mediated cytotoxicity.
我們相信 Fasenra 有潛力成為一流的藥物,因為它是一種靶向 IL-5 受體的抗嗜酸性粒細胞單克隆抗體,從而通過抗體依賴性細胞介導的細胞毒性誘導嗜酸性粒細胞的直接和接近完全耗竭。
Please turn now to Slide 35.
請現在轉到幻燈片 35。
I want to conclude by highlighting some of the news flow that you can see on this slide and expect for 2018 and 2019.
最後,我想強調您可以在這張幻燈片上看到的一些新聞流以及 2018 年和 2019 年的預期。
For Lynparza, we anticipate a regulatory decision for second-line ovarian cancer in the EU in the first half of the year.
對於 Lynparza,我們預計今年上半年歐盟將針對二線卵巢癌做出監管決定。
In first line, we expect a data readout for SOLO-1 in the first half and a regulatory submission in the second half.
在第一行,我們預計上半年將讀取 SOLO-1 的數據,下半年將提交監管文件。
Following the U.S. approval in breast cancer, we expect regulatory submission in the EU for Lynparza in this half and a regulatory decision in Japan in the second half of 2018.
在美國批准用於治療乳腺癌後,我們預計本半年將在歐盟提交 Lynparza 的監管申請,並於 2018 年下半年在日本做出監管決定。
For Tagrisso, as I mentioned earlier, we anticipate regulatory decision in the U.S. in the first half of the year and for the EU and Japan in the second half.
對於 Tagrisso,正如我之前提到的,我們預計今年上半年美國將做出監管決定,下半年歐盟和日本將做出監管決定。
Moving now to immuno-oncology.
現在轉向免疫腫瘤學。
We anticipate a U.S. regulatory decision for PACIFIC in Stage III unresectable lung cancer in this half of the year and for the EU and Japan in the second half.
我們預計今年下半年美國將針對 III 期不可切除肺癌 PACIFIC 做出監管決定,下半年將針對歐盟和日本做出監管決定。
Furthermore, as regard to lung cancer, we expect data readouts for MYSTIC and ARCTIC first half of the year with NEPTUNE following in the second half.
此外,關於肺癌,我們預計 MYSTIC 和 ARCTIC 的數據將在上半年公佈,而 NEPTUNE 將在下半年公佈。
For head and neck cancer, we expect data for KESTREL and EAGLE in the first half.
對於頭頸癌,我們預計上半年將有 KESTREL 和 EAGLE 的數據。
And our first-line bladder cancer trial DANUBE will have a data readout in 2019.
我們的一線膀胱癌試驗 DANUBE 將在 2019 年公佈數據。
In CVMD, DECLARE data will be available later this year.
在 CVMD 中,DECLARE 數據將於今年晚些時候提供。
We anticipate a regulatory decision for our Bydureon autoinjector in the EU in the second half of the year.
我們預計今年下半年歐盟將對我們的 Bydureon 自動注射器做出監管決定。
As I mentioned earlier, we anticipate a regulatory submission for roxadustat in the second half of 2018.
正如我之前提到的,我們預計將在 2018 年下半年提交 roxadustat 的監管申請。
In Respiratory, we have had a data readout for PT010 in COPD.
在呼吸方面,我們有 COPD 中 PT010 的數據讀數。
And at the same time, we expect regulatory submissions of Bevespi in Japan and Duaklir in the United States.
同時,我們期待日本的 Bevespi 和美國的 Duaklir 提交監管申請。
Finally, we expect data from anifrolumab, our lupus program, to read out in the second half of the year.
最後,我們預計我們的狼瘡項目 anifrolumab 的數據將在今年下半年公佈。
And with that, I'll hand back to Pascal.
然後,我將交還給 Pascal。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, Sean.
謝謝你,肖恩。
So I'll try to conclude quickly so we can actually dedicate the full 45 minutes to your questions.
所以我會盡量快點結束,這樣我們就可以用整整 45 分鐘來回答你們的問題。
So if we move to next slide, Slide 37.
因此,如果我們轉到下一張幻燈片,幻燈片 37。
Essentially the message I'd like to leave with -- leave you with is this has been a hard, long and arduous road over the last 4, 5 years dealing with these patent expiries.
基本上我想留下的信息——留給你的是,在過去的 4、5 年中,處理這些專利到期是一條艱難、漫長和艱鉅的道路。
And I think what we can say is that our development team has done a fantastic job developing this pipeline and bringing these products to approval.
我認為我們可以說的是,我們的開發團隊在開發這條管道並將這些產品推向批准方面做得非常出色。
And we have shown that we can execute on our pipeline and develop great products and implement really good clinical plans.
我們已經證明,我們可以執行我們的管道並開發出色的產品並實施非常好的臨床計劃。
And now we are actually showing that our commercial teams can do a great job and are doing a great job.
現在我們實際上表明我們的商業團隊可以做得很好並且做得很好。
Farxiga, Brilinta are blockbuster products.
Farxiga、Brilinta 是重磅產品。
Tagrisso.
塔格里索。
We launched Tagrisso at the end of 2015.
我們在 2015 年底推出了 Tagrisso。
Within 2 years, we made this product -- we turned this product into a blockbuster.
在 2 年內,我們製作了這個產品——我們把這個產品變成了重磅炸彈。
And it's growing extremely rapidly, and there's a lot more to come.
而且它的增長速度非常快,而且還會有更多。
We're in the process of launching Fasenra.
我們正在啟動 Fasenra。
And as we actually progress throughout 2018, you will be able to see how good a job our team in the U.S., to start with, and around the world is doing.
隨著我們在整個 2018 年取得實際進展,您將能夠看到我們在美國的團隊以及在世界各地所做的工作有多出色。
And the same will happen with Imfinzi.
同樣的事情也會發生在 Imfinzi 身上。
So I think we are really in a good place.
所以我認為我們真的處在一個好地方。
And getting to the end of this very difficult period we're experiencing, there's another year, 2018, to go and where we're still dealing with headwinds, the final patent expiries in Europe and Japan.
在我們正在經歷的這個非常困難的時期結束時,還有一年,即 2018 年,我們仍在應對不利因素,即歐洲和日本的最終專利到期。
And after this, 2019 and beyond, we really should experience a period of fast growth.
在此之後,2019 年及以後,我們真的應該經歷一段快速增長的時期。
So with that, I will conclude.
因此,我將得出結論。
And then we'll now move to the Q&A.
然後我們現在進入問答環節。
(Operator Instructions) We'll also take written questions from the webcast.
(操作員說明)我們還將接受網絡廣播中的書面問題。
Can I please remind everybody to limit questions to one to be fair to all of our callers.
我能否提醒大家將問題限制在一個範圍內,以便對我們所有的來電者公平。
Thanks in advance.
提前致謝。
And I need to speak another 7 seconds so we just finished 45 minutes and we have 45 minutes for questions.
我還需要再說 7 秒,所以我們剛剛結束了 45 分鐘,還有 45 分鐘的提問時間。
Where do we start?
我們從哪裡開始?
Sachin?
薩欽?
Sachin Jain - MD
Sachin Jain - MD
Sachin Jain from Bank of America.
美國銀行的 Sachin Jain。
I'll start off with a financial question from me for Marc, on the one-off income guidance of less than what was achieved in '17.
我將從我向 Marc 提出的財務問題開始,關於一次性收入指導低於 17 年取得的成就。
It's fairly broad, so I wonder if you could just give some directional commentary on where you think it sits versus combined externalization underlying consensus of $2.4 billion.
它相當廣泛,所以我想知道你是否可以就你認為它所處的位置與 24 億美元的綜合外部化基礎共識進行一些方向性評論。
And related, the guidance range obviously is $0.20.
與此相關,指導範圍顯然是 0.20 美元。
Is that predominantly relates to uncertainty on one-off income?
這是否主要與一次性收入的不確定性有關?
Or are there operational uncertainties in that?
還是其中存在運營不確定性?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Marc, do you want to cover these questions?
馬克,你想回答這些問題嗎?
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
So with the first question, on the sum of external revenue plus other income, as we said earlier and we repeated today, this -- the sum is going to be lower than that of 2017.
所以關於第一個問題,關於外部收入加上其他收入的總和,正如我們之前所說的和今天重複的那樣,總和將低於 2017 年的總和。
It's a bit difficult to tell you exactly what it will -- to be but with some reduction.
很難確切地告訴你它會是什麼——但會有所減少。
What I can say is that we are going to continue with external revenues, and we're going to continue also with other disposals.
我能說的是,我們將繼續處理外部收入,我們也將繼續進行其他處置。
So this is part of our business model, and this will continue.
所以這是我們商業模式的一部分,並將繼續下去。
I can't be more precise than that as of today.
我不能比今天更精確了。
On your second question, the range of the guidance $3.30 to $3.50, the -- there's obviously some uncertainty on the deals we will be able to conclude, but more importantly, we need to see the success behind the launch of our many new products or new formulation and line extensions.
關於你的第二個問題,3.30 美元到 3.50 美元的指導範圍,我們能夠達成的交易顯然存在一些不確定性,但更重要的是,我們需要看到我們推出許多新產品或新配方和產品線擴展。
So these are the 2 bigger factors of -- behind the range of our guidance in terms of EPS.
因此,這些是我們在 EPS 方面的指導範圍背後的兩個更大的因素。
Vincent Meunier - Research Analyst
Vincent Meunier - Research Analyst
Vincent Meunier from Morgan Stanley.
來自摩根士丹利的 Vincent Meunier。
I have a question on China and the strong uptake.
我有一個關於中國和強烈接受的問題。
Two questions in one.
兩個問題合二為一。
I mean, can you talk about the penetration of Tagrisso?
我的意思是,你能談談 Tagrisso 的滲透嗎?
You said that, that is already fairly high, but what should we expect going forward?
你說那已經相當高了,但我們應該期待什麼?
And also, what's the profitability in China?
還有,在中國的盈利能力如何?
And do you think that -- I mean, is it in line with the rest of the group?
你認為 - 我的意思是,它與小組的其他人一致嗎?
And do you think you can increase profitability in China?
您認為您可以提高在中國的盈利能力嗎?
Or do you think that [growing] there implies investing also there?
還是您認為在那裡 [成長] 意味著也在那裡投資?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
I'll ask Mark Mallon to maybe cover this one.
我會請 Mark Mallon 來報導這個。
But let me just correct if there is a misunderstanding.
但如果有誤解,讓我糾正一下。
I didn't say that the Tagrisso penetration in Japan is very high.
我沒說Tagrisso在日本的滲透率很高。
I mean, if it was very high, we would have already a multibillion dollar product because, as you know, almost 50% of patients with lung cancer in China have [an EGFR] mutation.
我的意思是,如果它非常高,我們就已經有了數十億美元的產品,因為正如你所知,中國近 50% 的肺癌患者有 [EGFR] 突變。
What I said is that the launch is going very well, and the sales are growing rapidly, and we're getting even reimbursement in some regions or cities already.
我說的是上線很順利,銷量增長很快,在一些地區或者城市已經連報銷了。
So with that, Mark, you want to cover the marginal question?
那麼,馬克,你想解決邊際問題嗎?
Mark Mallon - EVP-Global Product & Portfolio Strategy, Medical Affairs, Corporate Affairs & International West
Mark Mallon - EVP-Global Product & Portfolio Strategy, Medical Affairs, Corporate Affairs & International West
Yes.
是的。
So our business in China is growing, but it is also profitable, basically not very different, I would say, than the rest of our business overall.
所以我們在中國的業務在增長,但它也是有利可圖的,我想說,基本上與我們其他業務的整體差別不大。
Marc may even want to add a comment on that.
Marc 甚至可能想對此添加評論。
In terms of additional investments, I would say China is a place where we have a very strong platform already.
在額外投資方面,我想說中國是我們已經擁有非常強大平台的地方。
We will continue to invest, primarily focused in expanding our geographic reach in China because, even as big as our organization is, there's still many more hospitals, community health centers that we want to get to, to get our medicine.
我們將繼續投資,主要集中在擴大我們在中國的地理覆蓋範圍,因為即使我們的組織規模很大,我們仍然想去更多的醫院、社區衛生中心獲取我們的藥物。
So it's a fast-growing, profitable business.
因此,這是一項快速增長、有利可圖的業務。
We've got a great base.
我們有一個很好的基礎。
We'll invest to continue to expand our reach is the way I would describe it.
我們將投資以繼續擴大我們的影響力,這是我描述它的方式。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
That's a good description.
這是一個很好的描述。
(inaudible) example to highlight what Mark is saying about the potential for expansion.
(聽不清)示例,以強調 Mark 所說的關於擴展潛力的內容。
I was on this Street this week with the PM and a few other people.
這週我和首相以及其他一些人在這條街上。
The first stop was in a city called Wuhan, and I'm sure nobody has heard about Wuhan.
第一站是在一個叫武漢的城市,相信沒有人聽說過武漢。
So Wuhan is a city of 10 million people.
所以武漢是一個1000萬人口的城市。
So I asked him, "Is it an important city?" He said, "Not so much.
所以我問他:“這是一個重要的城市嗎?”他說:“沒那麼多。
It's medium priority, and it's growing.
它是中等優先級,並且正在增長。
It will be a priority in the near future, but it's still a small place." And you get there and the city is booming.
在不久的將來,這將是一個優先事項,但它仍然是一個小地方。”當你到達那裡時,這座城市正在蓬勃發展。
It's completely booming, and it's not in the dark ages.
完全是蓬勃發展,不至於處於黑暗時代。
It's actually rapidly catching up.
它實際上正在迅速趕上。
And we are only starting to penetrate that place.
我們才剛剛開始深入那個地方。
So there's enormous potential in China.
所以中國有巨大的潛力。
And I really think we are in a place -- we have an organization, fantastic team and an organization that is really equipped to leverage the full potential of China as it unfolds over the next few years.
我真的認為我們處於一個位置——我們有一個組織、出色的團隊和一個真正有能力利用中國在未來幾年展現的全部潛力的組織。
Dave, anything you want to add on Tagrisso and maybe IRESSA in China because those are so -- I mean, it's such an important market for EGFR inhibitors, of course.
戴夫,你想在中國的 Tagrisso 和 IRESSA 上添加任何東西,因為它們是如此 - 我的意思是,它當然是 EGFR 抑製劑的重要市場。
David Fredrickson - Executive VP & Global Head Oncology Business Unit
David Fredrickson - Executive VP & Global Head Oncology Business Unit
Yes.
是的。
I mean, I think that the direct piece to offer on the question that you asked about the penetration rates is that, maybe to put a fine point on Pascal's, is that they're relatively low for Tagrisso.
我的意思是,我認為關於你問的關於滲透率的問題的直接部分是,也許要對 Pascal 提出一個很好的觀點,那就是 Tagrisso 的滲透率相對較低。
So the sales and the speed with which we've been able to get sales and to get reimbursement from some regional players has been certainly faster than we've seen with other new products.
因此,我們能夠從一些區域性參與者那裡獲得銷售和報銷的銷售和速度肯定比我們在其他新產品上看到的要快。
But in terms of the opportunity that still exists in china, there's considerable.
但就中國仍然存在的機會而言,還有相當大的機會。
And I think that that's probably not really going to unlock until you start seeing reimbursement happening more broadly.
而且我認為,在您開始看到更廣泛的報銷發生之前,這可能不會真正解鎖。
And I think that there are other analogs and examples of that, that you can see how that affects the penetration.
而且我認為還有其他類似物和例子,你可以看到它是如何影響滲透率的。
In terms of IRESSA, our more mature, established brands continue to grow in China.
就易瑞沙而言,我們更成熟、更成熟的品牌在中國繼續增長。
So whereas IRESSA, Faslodex, Zoladex are not part of our growth drivers outside of China; within China, those are all growing in the double digits.
因此,雖然 IRESSA、Faslodex、Zoladex 不是我們在中國以外的增長動力的一部分;在中國,這些都以兩位數的速度增長。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, David.
謝謝你,大衛。
Take, maybe, one question online, and then we come back to the room, Richard and Andrew.
也許,在線回答一個問題,然後我們回到房間,Richard 和 Andrew。
Tim Anderson, Tim, do you want to go ahead?
蒂姆安德森,蒂姆,你想繼續嗎?
Timothy Minton Anderson - Senior Analyst
Timothy Minton Anderson - Senior Analyst
A question on MYSTIC.
關於 MYSTIC 的問題。
Investors often seem to lose sight of the fact that you have a durva mono arm in this trial and a positive that would give you a first-line monotherapy indication alongside KEYTRUDA possibly even in the current year.
投資者似乎常常忽視這樣一個事實,即您在該試驗中擁有 durva 單臂,並且即使在當年也可能為您提供與 KEYTRUDA 一起的一線單藥治療適應症。
That would seem quite relevant, especially as PACIFIC gets approved in Stage 3. So I'm wondering if I could just get your latest thinking on the least of this arm with MYSTIC being positive given now the trials powered, given where you've set your cut points and that sort of thing?
這似乎很相關,尤其是當 PACIFIC 在第 3 階段獲得批准時。所以我想知道我是否可以得到你對這支手臂的最新想法,因為 MYSTIC 是積極的,因為現在試驗已經開始,你已經設定了你的切分之類的?
Is it safe to assume you'd say that positive results are highly likely?
假設您會說極有可能獲得積極結果是否安全?
And can I just slip in one quick question on tax rate guidance.
我可以簡單地提出一個關於稅率指導的問題嗎?
The bracket is so big, 16% to 20%.
支架這麼大,16%到20%。
I'm wondering what explains that?
我想知道這是怎麼解釋的?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Tim.
謝謝,蒂姆。
So I guess the first question is for you, Sean.
所以我想第一個問題是給你的,肖恩。
The next is for Marc.
接下來是馬克。
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Okay, I'll start, Tim, with your MYSTIC question.
好的,蒂姆,我將開始你的神秘問題。
Yes, what you described in the design of MYSTIC is exactly right.
是的,您在 MYSTIC 的設計中所描述的完全正確。
It's got 3 arms.
它有 3 個手臂。
It's Imfinzi monotherapy, Imfinzi plus tremelimumab combination IO, and then obviously, the doublet chemotherapy control arm.
它是 Imfinzi 單一療法、Imfinzi 加 tremelimumab 組合 IO,然後顯然是雙重化療對照組。
There's also -- it enrolls all comers, but the data is analyzed by PD-L1 expression levels, so that you can look at higher expressing patients.
還有——它招募了所有參與者,但數據是通過 PD-L1 表達水平分析的,這樣你就可以看到表達水平更高的患者。
With regard to probability of success for the trial, what we know is from KEYTRUDA in very high expressors PL-1 that, that is validated therapeutic hypothesis with a PD-1 in that select like patient group versus chemotherapy.
關於試驗成功的可能性,我們從非常高表達 PL-1 中的 KEYTRUDA 知道,這是經過驗證的治療假設,在選擇像患者組與化療的情況下使用 PD-1。
What's a little confusing about interpreting the data out in the world was that if you look at the BMS data, it didn't seem to show that same pattern, and it's not 100% clear why that difference between the 2. We do consider monotherapy and high expressors a validated therapeutic hypothesis.
解釋世界上的數據有點令人困惑的是,如果你查看 BMS 數據,它似乎沒有顯示相同的模式,而且也不是 100% 清楚為什麼兩者之間存在差異。我們確實考慮了單一療法和高表達者是經過驗證的治療假設。
We also, as we've said many times, consider overall survival not only the more meaningful endpoint for patients, but actually the endpoint that better captures the benefit of IO treatments, and so that's the final readout and primary endpoint that will readout the first half of this year.
正如我們多次說過的那樣,我們還認為總體生存不僅是對患者更有意義的終點,而且實際上是更好地捕捉 IO 治療益處的終點,因此這是最終讀數和主要終點,將首先讀出今年的一半。
So with that, we're cautiously optimistic about the MYSTIC trial for monotherapy in high expressors and then also the hypotheses we may test with, with combination.
因此,我們對高表達者單藥治療的 MYSTIC 試驗持謹慎樂觀態度,然後我們也對我們可能測試的假設持謹慎樂觀態度。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Sean.
謝謝,肖恩。
Marc?
馬克?
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
Yes, regarding the 2018 tax rate from 16% to 20%, this is the usual range we provide.
是的,關於2018年的稅率從16%到20%,這是我們通常提供的範圍。
We did the same in 2017.
我們在 2017 年做了同樣的事情。
When we advance in the year, we narrowed down that range from 17% to 19%.
當我們在今年前進時,我們將該範圍從 17% 縮小到 19%。
But as you saw, due to variability on various movements and so on, we finished at 14%.
但正如您所見,由於各種運動的可變性等,我們以 14% 結束。
So I tend to be relatively cautious, and this is why I would prefer to keep the range of 16% to 20% because this is very variable.
所以我傾向於相對謹慎,這就是為什麼我更願意保持 16% 到 20% 的範圍,因為這是非常可變的。
The tax rate is a very variable matter depending on various negotiations with various geographies.
稅率是一個非常多變的問題,取決於與不同地區的各種談判。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Marc.
謝謝,馬克。
So Richard and then Andrew.
先是理查德,然後是安德魯。
Richard J. Parkes - Director
Richard J. Parkes - Director
Richard Parkes from Deutsche Bank.
德意志銀行的理查德·帕克斯。
I got a financial one for Marc.
我有一份給馬克的財務報告。
I think your guidance on (inaudible) you've given on SG&A cost suggests that those costs will be about $500 million higher than consensus was assuming before the results.
我認為你就 SG&A 成本給出的(聽不清)指導表明,這些成本將比結果公佈前的共識假設高出約 5 億美元。
And obviously, your investing behind the launches, but that figure just seemed a bit higher than I would have thought given that you're leveraging some of the -- your existing sales force or those launches need relatively modest investment.
很明顯,你在發布背後的投資,但這個數字似乎比我想像的要高一點,因為你正在利用一些 - 你現有的銷售人員或那些發布需要相對適度的投資。
So I just wondered if you could walk through that?
所以我只是想知道你是否可以通過它?
I'm just wondering whether consensus was overestimating the impact from the cost-savings programs?
我只是想知道共識是否高估了成本節約計劃的影響?
Or actually, you've decided to reinvest back elsewhere in the business as well as those new launches?
或者實際上,您已經決定在業務的其他地方以及那些新推出的產品上進行再投資?
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
So you're asking me to define whether it's above or under $500 million?
所以你要我定義它是高於還是低於 5 億美元?
I think $500 million would probably be the higher range of it.
我認為 5 億美元可能是更高的範圍。
I mean, we are investing selectively behind our products being launched or launch preparation.
我的意思是,我們正在有選擇地投資於我們正在推出或推出準備的產品。
We have several of them.
我們有幾個。
We have 7 of them.
我們有 7 個。
So some of them are in existing fields where we're already operating, so the cost increase is minimal.
所以其中一些在我們已經運營的現有領域,所以成本增加是最小的。
In some others, we have some more.
在其他一些地方,我們還有更多。
Pascal was mentioning China.
帕斯卡提到了中國。
Every year, we do invest further in China.
每年,我們都會在中國進一步投資。
And of course, this is also costing us money.
當然,這也讓我們付出了代價。
The payback is extremely rapid, so we continue doing it.
回報非常快,所以我們繼續這樣做。
But they are -- mostly, it's on the specialized sales forces that we need to launch all our new products, our new formulation or line extension and some additional expenditures in China, I would say.
但他們——主要是,我們需要專業的銷售人員來推出我們所有的新產品、我們的新配方或產品線擴展以及我想說的在中國的一些額外支出。
This is probably the gist of the increase of the SG&A in 2018.
這可能是 2018 年 SG&A 增加的要點。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
And maybe, Marc, let me add that -- I don't know how you computed $500 million, which are the -- I was double-, triple-checking our guidance to make sure I have the right numbers in mind.
也許,馬克,讓我補充一點——我不知道你是如何計算出 5 億美元的——我對我們的指導進行了雙重、三次檢查,以確保我記住了正確的數字。
we guided to -- we guided for low- to mid-single-digit increase.
我們指導了 - 我們指導了中低個位數的增長。
That doesn't translate into $500 million, less than that.
這不會轉化為 5 億美元,比這還少。
Richard J. Parkes - Director
Richard J. Parkes - Director
(inaudible) implies versus where consensus was before the results for next year but...
(聽不清)暗示與明年結果之前的共識相比,但......
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Okay.
好的。
Andrew?
安德魯?
Unidentified Analyst
Unidentified Analyst
Marc, your colleagues in oncology normally take the disproportionate amount of the questions on the therapeutic side.
Marc,您的腫瘤學同事通常會在治療方面提出不成比例的問題。
Could we talk about Farxiga, which is obviously $1 billion product now?
我們能談談 Farxiga 嗎,它現在顯然是價值 10 億美元的產品?
We happen to have taken a view that we think given the certain members of the class and the pending data and declare this could be a substantially undervalued asset.
我們碰巧採取了一種觀點,即我們認為考慮到該類別的某些成員和待定數據,並宣布這可能是一項被嚴重低估的資產。
Could you humor us if DECLARE hits for both primary and secondary prevention and is further validated by heart failure trials and the ADA guidance on cardiovascular outcome, how large a product can this actually be prior to the patent expiry?
如果 DECLARE 對一級和二級預防均有效,並通過心力衰竭試驗和 ADA 心血管結局指南進一步驗證,您能否幽默地告訴我們,在專利到期之前,該產品實際上有多大?
And then just a quick add-on.
然後只是一個快速的附加組件。
The interim analysis for Dapa-HF.
Dapa-HF 的中期分析。
We're expecting it this year.
我們期待今年。
Would I be right in thinking that's a reasonable assumption?
我認為這是一個合理的假設是否正確?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Should we maybe start with the heart failure readout question and then look back into the commercial question?
我們是否應該從心力衰竭讀數問題開始,然後再回顧商業問題?
Sean, do you want to cover that?
肖恩,你想報導嗎?
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
I think that was a cue for me.
我認為這是對我的暗示。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Well, you can answer the commercial question and Mark, the development one, if you want, but...
好吧,如果你願意,你可以回答商業問題和馬克,開發問題,但是......
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Oh, I'd be very happy to forecast what I think Farxiga would be worth.
哦,我很樂意預測我認為 Farxiga 的價值。
But the -- so the heart failure question is we do incorporate an interim analysis into these trials.
但是——所以心力衰竭的問題是我們確實將中期分析納入了這些試驗。
I think maybe, Andrew, I'm going to expand a little bit for everyone.
我想也許,安德魯,我要為每個人擴展一點。
So the Dapa-HF trial Andrew's referring to is a trial of Farxiga for the treatment of heart failure in both diabetics and nondiabetics.
所以安德魯提到的 Dapa-HF 試驗是 Farxiga 用於治療糖尿病患者和非糖尿病患者心力衰竭的試驗。
So what it would do is it would enable the use of Farxiga if positive outside of diabetes as well.
所以它會做的是,如果 Farxiga 在糖尿病之外也呈陽性,那麼它也可以使用 Farxiga。
There are interim analyses.
有中期分析。
We don't get into the details of how they're powered or when they're done, and so we have them.
我們沒有深入了解它們的供電方式或完成時間的細節,因此我們擁有它們。
And then if they're positive, we announce them otherwise.
然後,如果他們是積極的,我們會以其他方式宣布。
Our assumption is that we go ahead into the final analysis, so I cannot provide more detail than that.
我們的假設是我們繼續進行最終分析,所以我無法提供更多細節。
Mark Mallon - EVP-Global Product & Portfolio Strategy, Medical Affairs, Corporate Affairs & International West
Mark Mallon - EVP-Global Product & Portfolio Strategy, Medical Affairs, Corporate Affairs & International West
So in terms of the potential, I know Mark would caution me to say that we don't provide guidance, but what I can say is we see substantial further opportunity for Farxiga in the class.
因此,就潛力而言,我知道 Mark 會提醒我說我們不提供指導,但我可以說的是,我們看到 Farxiga 在課堂上有更多的機會。
Of course, it's $1 billion-plus brand already growing in mid-20s.
當然,這個價值超過 10 億美元的品牌在 20 多歲時就已經成長起來了。
We just launched the product of Farxiga.
我們剛剛推出了 Farxiga 的產品。
That's further upside.
這是進一步的好處。
We've expanded access in the U.S. There's still a tremendous room in terms of changing practice.
我們已經擴大了在美國的訪問範圍。在改變實踐方面仍有巨大的空間。
There's only a couple countries in the world where SGLT2s are in guidelines ahead of DPP4s even though we have now outstanding evidence showing that this really has -- class has a great cardiovascular benefit.
世界上只有幾個國家在指南中將 SGLT2 排在 DPP4 之前,儘管我們現在有出色的證據表明這確實具有 - 類別具有很大的心血管益處。
So we still have a lot of work to do on the education.
所以我們在教育方面還有很多工作要做。
DECLARE will have a very big impact on that if it's positive because of the breadth of the patient -- risk profiles of the patients in the study.
DECLARE 將對此產生非常大的影響,如果它是積極的,因為患者的廣度 - 研究中患者的風險狀況。
And then, of course, that's just in the diabetes area.
然後,當然,這只是在糖尿病領域。
If we're successful in the cardiovascular program, that's all further upside.
如果我們在心血管計劃中取得成功,那將是一個更大的好處。
So this can be a very substantial product.
所以這可能是一個非常重要的產品。
We're absolutely committed to it across the globe.
我們絕對致力於在全球範圍內實現這一目標。
And we haven't mentioned it, but we're excited, we actually now have the first major country in the world where Farxiga is the #1 innovative oral anti-diabetes product, and that's in Brazil, which is a very major market, bigger than GALVUS, bigger than Januvia.
我們沒有提到它,但我們很興奮,我們實際上現在擁有世界上第一個 Farxiga 是排名第一的創新口服抗糖尿病產品的主要國家,那就是巴西,這是一個非常重要的市場,比 GALVUS 大,比 Januvia 大。
That's where we're aiming to take this medicine.
這就是我們服用這種藥的目標。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Unfortunately, the countries where SGLT2s are recommended as first after metformin instead of DPP4 are small countries.
不幸的是,在二甲雙胍而不是 DPP4 之後,首先推薦 SGLT2 的國家都是小國家。
One of them is Singapore.
其中之一是新加坡。
But hopefully, with a lot of good work, we'll be able to modify the guidelines.
但希望通過大量出色的工作,我們能夠修改指南。
And if that class becomes first line after metformin, the potential, as Mark said, is enormous.
如果該類藥物成為繼二甲雙胍之後的一線藥物,那麼正如馬克所說,其潛力是巨大的。
It could also have added CKD, kidney disease because we also have a program in kidney disease.
它也可能增加了 CKD,腎臟疾病,因為我們也有一個腎臟疾病項目。
And that's really where actually our strategy takes its full potential because we're going to be in kidney disease.
而這正是我們的戰略真正發揮其全部潛力的地方,因為我們將患上腎臟疾病。
We're going to be in heart failure with a variety of products: Farxiga, of course; roxadustat; in kidney disease, LOKELMA; in cardiology, we have Brilinta.
我們將因各種產品而心力衰竭:當然是 Farxiga;羅沙司他;在腎臟疾病中,LOKELMA;在心髒病學方面,我們有 Brilinta。
We'll have, hopefully, Farxiga.
希望我們有 Farxiga。
We'll have LOKELMA, and so we really will have a strong portfolio in each of those -- these areas.
我們將擁有 LOKELMA,因此我們真的將在這些領域中的每一個領域擁有強大的投資組合。
Simon P. Baker - Analyst
Simon P. Baker - Analyst
This is Simon Baker from Exane.
我是 Exane 的 Simon Baker。
If I can just go back to Richard's question on SG&A.
如果我可以回到理查德關於 SG&A 的問題。
Marc, you talked about essentially 2 moving parts within SG&A and continued efficiencies in the underlying SG&A versus investments in new projects and new launches.
馬克,你基本上談到了 SG&A 中的兩個移動部分,以及基礎 SG&A 與新項目和新發布投資的持續效率。
I wonder if you could give us a little bit more color on the trend there, particularly in 2018, what that underlying SG&A could do?
我想知道你是否可以給我們更多關於那裡趨勢的顏色,特別是在 2018 年,潛在的 SG&A 可以做什麼?
And then if I can, I'll chance my arm on moving onto 2019.
然後,如果可以的話,我會碰碰運氣進入 2019 年。
But I wonder if you could give us a feel for -- and I've asked this question many times before -- on the trajectory of SG&A beyond 2018?
但我想知道您是否可以讓我們對 2018 年以後的 SG&A 軌蹟有一種感覺——我之前已經多次問過這個問題?
There is a general feeling within the market that at some point in the future, the SG&A burden of AstraZeneca will be somewhat lower than it is now.
市場普遍認為,在未來的某個時候,阿斯利康的 SG&A 負擔將比現在低一些。
There's a lot of debate as to how low and when.
關於多低和何時下降有很多爭論。
So I wonder if you could sort of flesh out as much as you're prepared to do what we should think of in 2019?
所以我想知道你是否可以像你準備做的那樣充實我們在 2019 年應該想到的事情?
How much of the SG&A increase this year is transient versus permanent to give us an idea for the long-run SG&A requirements of the company?
今年 SG&A 的增長有多少是暫時的,而不是永久的,以便我們了解公司的長期 SG&A 要求?
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
So thank you very much for this very good question.
所以非常感謝你提出這個非常好的問題。
The SG&A, basically, you have 2 different phenomenons.
SG&A,基本上,你有兩種不同的現象。
You have the continued cost discipline of the company, which is obviously impacting SG&A, but also it's done all across the company.
你有公司持續的成本紀律,這顯然影響了 SG&A,但它也在整個公司範圍內完成。
We could say the same on the late-stage development division, they're also doing great efforts on cost discipline and productivity increases.
我們可以對後期開發部門說同樣的話,他們也在成本控制和提高生產力方面做出了巨大努力。
So this goes all across the company, and obviously, this reduces the cost.
所以這在整個公司都有,顯然,這降低了成本。
I've also talked about the launches, and I would say the accumulation of launches that we are confronted to now -- we have 7 products in launch or in launch preparations.
我也談到了發布,我想說的是我們現在面臨的發布的積累——我們有 7 種產品正在發布或準備發布。
Obviously, this impacts negatively the SG&A.
顯然,這對 SG&A 產生了負面影響。
To your question on the longer term, as we are moving progressively towards a more balanced company between primary care and specialty care, including oncology, the cost of doing business is going to, over medium and longer term, reduce proportionally.
對於您的長期問題,隨著我們逐步朝著初級保健和專科保健(包括腫瘤學)之間更加平衡的公司邁進,從中長期來看,開展業務的成本將按比例減少。
So there's these 3 factors.
所以有這3個因素。
We have greater efficiencies on the overall company.
我們提高了整個公司的效率。
We have the nature or the number of launches.
我們有發射的性質或數量。
Where do we launch?
我們在哪裡發射?
How many products do we launch in a given year?
我們在給定的一年推出多少產品?
And then you have the long-term trend where we're moving from primary care, predominantly, to a mix of primary care and specialty care.
然後你就會看到我們正在從主要的初級保健轉向初級保健和專科保健的長期趨勢。
So over time, one can expect that the SG&A ratio will diminish to some extent.
因此,隨著時間的推移,可以預期 SG&A 比率會在一定程度上下降。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
I think it's important to keep in mind, remember, that at the end of the day, we have a pipeline that is oversized relative to the total size of the company.
我認為重要的是要記住,記住,在一天結束時,我們的管道相對於公司的總規模來說是超大的。
I mean, we have all these launches Marc is talking about, and it was a base business that is small in relation to the pipeline.
我的意思是,我們有 Marc 正在談論的所有這些發布,這是一個相對於管道來說很小的基礎業務。
So the good news is we'll be able to experience a fast growth rate as soon as we get out of these patent expiries.
所以好消息是,一旦我們擺脫這些專利到期,我們就能體驗到快速增長。
But then the issue of cost in the near term is we have to fund those launches.
但近期的成本問題是我們必須為這些發射提供資金。
Some are more expensive than others, of course.
當然,有些比其他的貴。
Oncology, suddenly -- Tagrisso is less expensive, but products like Fasenra require a lot of investment to shape the market and get the full potential of this product.
腫瘤學,突然間——Tagrisso 便宜了,但像 Fasenra 這樣的產品需要大量投資才能塑造市場並充分發揮該產品的潛力。
But by 2019/2020, there's no doubt our ratio will drop, and we want to get to operating margins that are industry -- that are in line with the industry.
但到 2019/2020 年,毫無疑問我們的比率會下降,我們希望達到行業的營業利潤率——與行業一致。
So we definitely need to increase our operating margin.
所以我們肯定需要提高我們的營業利潤率。
There's no question.
毫無疑問。
But to minimize the investment at this point in time would actually not maximize the potential of our products.
但是在這個時間點上最小化投資實際上並不能最大程度地發揮我們產品的潛力。
If you think about it, we are really not wasting money.
仔細想想,我們真的不是在浪費錢。
In the U.S. -- I'll give an example, in the U.S., our Symbicort's share of voice is lower than the competition.
在美國——我舉個例子,在美國,我們 Symbicort 的話語權份額低於競爭對手。
We're driving market share increase, as Marc showed you earlier, in the U.S. with a lower share of voice.
我們正在推動市場份額的增加,正如馬克早些時候向您展示的那樣,在美國的話語權份額較低。
In diabetes, we also do not have an overwhelming share of voice.
在糖尿病方面,我們也沒有壓倒性的發言權。
So it's not like we're overspending relative to the competition, it's just the nature of the pipeline, the portfolio and the number of launches we have.
所以這並不是說我們相對於競爭對手超支,這只是管道的性質、產品組合和我們擁有的發布數量。
But this will disappear as those products launch and they start generating sales.
但隨著這些產品推出並開始產生銷售,這種情況將會消失。
I mean, if you look at Tagrisso, it's already very profitable.
我的意思是,如果你看看 Tagrisso,它已經非常有利可圖了。
I mean, as you can imagine, very profitable.
我的意思是,如你所想,非常有利可圖。
And we just need to get all these launches to critical mass to become profitable.
我們只需要讓所有這些發射達到臨界質量就可以盈利。
And maybe last point is China.
也許最後一點是中國。
China is actually a profitable market.
中國實際上是一個有利可圖的市場。
We've been investing because we've been growing at fast pace and then we keep investing to keep pushing this growth.
我們一直在投資,因為我們一直在快速增長,然後我們繼續投資以繼續推動這種增長。
But actually, it's profitable, and the profitability is similar to what we get in Europe.
但實際上,它是有利可圖的,而且盈利能力與我們在歐洲獲得的相似。
And as we gain critical mass and become even bigger, the profitability would go up, mechanically.
隨著我們獲得臨界質量並變得更大,盈利能力將機械地上升。
Sorry, (inaudible), I'll get to you next time.
抱歉,(聽不清),我下次再找你。
I missed you a few times.
我想念你幾次。
Unidentified Analyst
Unidentified Analyst
You've given us, obviously, lots of information by lots of different parts of the businesses, but one of the biggest contributors is the externalization and 22% of EBIT is from nonrecurring externalization.
很明顯,您已經為我們提供了很多不同業務部門的大量信息,但最大的貢獻者之一是外部化,22% 的息稅前利潤來自非經常性外部化。
You've given us guidance for this year, but we need some color going forward as to how quickly the quality of the earnings will improve.
您已經為我們提供了今年的指導,但我們需要一些關於盈利質量提高速度的顏色。
So could you give us some sense as to what's left in the pipeline that you think will come up in the imminent future that you think you could continue to externalize and where we should expect that line to go?
那麼,您能否告訴我們一些關於您認為在不久的將來會出現的管道中剩下的東西,您認為您可以繼續外部化以及我們應該期望這條線走向何方?
And then following on from that, we've had billions of dollars worth of disposals over the last 2 or 3 years.
然後在過去的 2 或 3 年裡,我們進行了價值數十億美元的處置。
So when do you -- how do you see that progressing over the next 2 or 3 years?
那麼你什麼時候 - 你如何看待未來 2 或 3 年的進展?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
So Marc, this is a question for you, but let me just make a general, sort of, comment.
馬克,這是一個問題,但讓我做一個一般性的評論。
In term of strategically where we're trying to achieve because this all of sorts of deciphering or reading of what we're trying to do is externalization.
就戰略而言,我們正在努力實現的目標,因為對我們正在努力做的事情進行的各種破譯或閱讀都是外化。
Essentially, what we're trying to do is build a portfolio that is completely aligned with our strategy.
從本質上講,我們正在努力做的是建立一個完全符合我們戰略的投資組合。
I was reading recently an interview by a CEO of a large mining company and he was explaining that they're building the perfect portfolio for them.
我最近正在閱讀一家大型礦業公司首席執行官的採訪,他解釋說他們正在為他們建立完美的投資組合。
They're selling mines and buying other mines.
他們正在出售地雷併購買其他地雷。
And this is essentially what we are doing.
這基本上就是我們正在做的事情。
It's very similar.
這是非常相似的。
Ultimately, what we want is almost the totality of our sales to come from those 3 core therapy areas.
最終,我們想要的是幾乎所有的銷售額都來自這 3 個核心治療領域。
So we are investing in those 3 core TAs.
所以我們正在投資這 3 個核心 TA。
And we are partnering or divesting, partnering new products and sometimes even tail products but -- and divesting all the products that do not fit.
我們正在合作或剝離,合作新產品,有時甚至是尾部產品,但剝離所有不合適的產品。
And at some point, that will show up in our growth rate, of course, and leverage across the business.
在某個時候,這當然會體現在我們的增長率和整個業務的影響力上。
More specifically, Marc, do you want to comment on the financials?
更具體地說,馬克,你想對財務狀況發表評論嗎?
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
You covered the big principle behind it.
你涵蓋了它背後的大原則。
I think externalization, as we have said many times, is part of our business model.
正如我們多次所說,我認為外部化是我們商業模式的一部分。
We find it -- we find alternative ways to generate revenues for the company in areas where we cannot do it or we wouldn't do it as well or would not do it as fast.
我們找到了 - 我們找到了替代方法,在我們無法做到或我們不會做得那麼好或不會做得那麼快的領域為公司創造收入。
We have several examples where we have done it.
我們有幾個例子,我們已經做到了。
I think what you need to remember is in thinking about the sustainability of this, so first of all, it's part of our business model.
我認為你需要記住的是考慮它的可持續性,所以首先,它是我們商業模式的一部分。
We still have other opportunities, but you also need to remember that the company is progressively returning to growth.
我們還有其他機會,但您還需要記住,公司正在逐步恢復增長。
So what you see as 22% today.
所以你今天看到的是 22%。
If you look at the percentage of EBIT, very soon will become much smaller.
如果你看一下 EBIT 的百分比,很快就會變得小得多。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Yes.
是的。
We've always said that it that we would peak and then continue doing it because it's part of the model.
我們一直說我們會達到頂峰然後繼續這樣做,因為它是模型的一部分。
But, suddenly, the amount of upfront milestone will decline, and so this externalization income would decline progressively.
但是,突然間,前期里程碑的金額會下降,因此這種外部化收入會逐步下降。
And essentially, by around 2020, we want to have the sustainable business, if I go in this way, to basically generate sufficient profitability to cover the dividend and more.
從本質上講,到 2020 年左右,我們希望擁有可持續的業務,如果我這樣做的話,基本上可以產生足夠的盈利能力來支付股息等等。
So that's really this interim period.
所以這真的是這個過渡時期。
I mean, strategically, we're building a portfolio which is totally aligned with our focus.
我的意思是,從戰略上講,我們正在建立一個與我們的重點完全一致的投資組合。
And secondly, it's capital redeployment.
其次,它是資本重新部署。
It's capital allocation.
就是資本配置。
We basically use this income to fuel the build of our 3 core TAs.
我們基本上使用這筆收入來推動我們 3 個核心 TA 的建設。
Jo?
喬?
Jo Walton - MD
Jo Walton - MD
Jo Walton from Credit Suisse.
瑞士信貸的喬沃爾頓。
Three questions, please.
請教三個問題。
I wonder if you could just give us the total aggregate amount of the true-ups that benefited you in the fourth quarter?
我想知道您是否可以告訴我們第四季度使您受益的調整總數?
I understand you don't want to give it to us product-by-product, but I assume it was also just a bit beyond Respiratory because drugs like Crestor in the U.S. had a bounce-up in the fourth quarter as well.
我知道你不想逐個產品給我們,但我認為它也只是有點超出了呼吸系統,因為美國的 Crestor 等藥物在第四季度也出現了反彈。
Second question is whether you could help us with the level of depression of the gross margin that you're expecting.
第二個問題是你是否可以幫助我們解決你所期望的毛利率下降水平。
Would the fourth quarter gross margin of 79.4% be a reasonable guide to look at going forward against the 81%-or-so that we saw for the full year in '17 and then finally, Respiratory question.
第四季度 79.4% 的毛利率是否是一個合理的指導,以展望我們在 17 年全年看到的 81% 左右的水平,最後是呼吸問題。
I'm intrigued that you're putting a lot of effort behind Symbicort in the U.S. ahead of what would be likely to see a generic Advair some time in 2018.
我很好奇您在美國的 Symbicort 背後付出了很多努力,而不是在 2018 年的某個時候可能會看到仿製藥 Advair。
Just wondering what you think the impact on Symbicort will be, whether there'll be a generics-first strategy that you will have to overcome in that market?
只是想知道您認為對 Symbicort 的影響是什麼,是否會有您必須在該市場上克服的仿製藥優先戰略?
And perhaps to chance my luck as well, you're putting a lot of effort behind Bydureon and the new pen there.
也許也是為了碰碰運氣,你在 Bydureon 和那裡的新筆上付出了很多努力。
How do you see that competing against the very high level of investment being put by Lilly and Novo into the GLP market?
您如何看待禮來和 Novo 對 GLP 市場的高水平投資競爭?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
It's not only 3, it's 4 questions.
不只是3個,是4個問題。
So we should only pick one or -- maybe the first one, I suspect Marc is not going to give you much further detailed response, so maybe I can give you this one.
所以我們應該只選擇一個,或者——也許是第一個,我懷疑 Marc 不會給你更詳細的回复,所以也許我可以給你這個。
You want, Marc, the true-ups and the gross margin, and the other Mark will cover the Respiratory question?
馬克,你想要校準和毛利率,而另一個馬克將涵蓋呼吸系統問題?
Is that okay?
這樣可以嗎?
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
So for the true-up, my recommendation -- sorry, my recommendation would be not to look too much at the fourth quarter, which was impacted by more true-up that are corresponding to the rest of the year.
因此,對於調整,我的建議 - 抱歉,我的建議是不要過多地關注第四季度,第四季度受到與今年剩餘時間相對應的更多調整的影響。
I think if you look at the overall year 2017, this gives you a good view of the progression of our portfolio.
我想如果你看一下 2017 年的全年,這會讓你很好地了解我們投資組合的進展。
And you will see the progressive reduction of the headwinds, and therefore, it gives you a better view.
你會看到逆風逐漸減少,因此,它給了你更好的視野。
So my advice is don't look at the fourth quarter.
所以我的建議是不要看第四季度。
Think about this true-up as applying to the full year 2017.
考慮將此調整應用於 2017 年全年。
Another indication, if you look at which type of products, we don't want to give a product-by-product detail, but what I can say that most of the true-up are concerned -- concern the legacy product and less so for the newer product.
另一個跡像是,如果您查看哪種類型的產品,我們不想逐個提供產品的詳細信息,但我可以說的是,大多數調整都涉及 - 涉及遺留產品,而不是遺留產品對於較新的產品。
And then your second question, maybe it was the third, I don't remember.
然後你的第二個問題,也許是第三個,我不記得了。
On the gross margin level, when we were in quarter 3, 2017, I mentioned that we would not see large variation.
在毛利率水平上,當我們在 2017 年第三季度時,我提到我們不會看到很大的變化。
So I think if you looked at the gross margin level in the second half of 2017, I think it would provide you a good indication for where the gross margin should be in 2018.
所以我認為,如果你看一下 2017 年下半年的毛利率水平,我認為這將為你提供一個很好的指標,說明 2018 年的毛利率應該在哪裡。
But do not look at the first half because there were factors which were distorting it.
但是不要看上半年,因為有一些因素在扭曲它。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
And let me just repeat what Marc said because it's important in terms of true-up.
讓我重複一下 Marc 所說的話,因為它在調整方面很重要。
It really affects -- the great majority is affecting the legacy products.
它確實影響了——絕大多數都在影響遺留產品。
To some extent, it's not so relevant because those products are going away anyway in the U.S. and the core products are not affected by those true-ups.
在某種程度上,它並沒有那麼重要,因為這些產品無論如何都會在美國消失,而核心產品不受這些調整的影響。
So you can look at the growth rate of those products and be confident that this is not affected by those true-ups.
因此,您可以查看這些產品的增長率,並確信這不會受到這些調整的影響。
Mark Mallon, Respiratory?
馬克馬龍,呼吸?
Mark Mallon - EVP-Global Product & Portfolio Strategy, Medical Affairs, Corporate Affairs & International West
Mark Mallon - EVP-Global Product & Portfolio Strategy, Medical Affairs, Corporate Affairs & International West
Yes, so first of all, in terms of Respiratory, the question around Symbicort investment and Advair generics, I mean, our expectation is that the bulk of the effect of that many analogs or generics for Advair will focus on Advair.
是的,所以首先,就呼吸系統而言,關於 Symbicort 投資和 Advair 仿製藥的問題,我的意思是,我們的預期是 Advair 的許多類似物或仿製藥的大部分影響將集中在 Advair 上。
That's not to say there won't be some impact.
這並不是說不會有一些影響。
But we're really expecting in other places the substitution is sort of within the molecule, and -- because it's hard to change devices and molecules in the Respiratory area in general.
但我們真的期待在其他地方,這種替代是在分子內進行的,而且——因為一般來說很難改變呼吸領域的設備和分子。
We plan for continued intense competition in that category, so I think we've got realistic expectations around pricing and the competition in the market.
我們計劃在該類別中繼續進行激烈的競爭,所以我認為我們對定價和市場競爭有現實的期望。
And we're confident we can be successful.
我們有信心我們能夠成功。
it's really important because we've got a very exciting and [held] portfolio ahead of us.
這真的很重要,因為我們前面有一個非常令人興奮和 [持有] 的投資組合。
We've got -- we've just only launched Bevespi.
我們已經——我們剛剛推出了 Bevespi。
We've got PT010 coming.
我們有 PT010 來了。
And there's still huge unmet need in this category.
在這一類別中仍然存在巨大的未滿足需求。
So we remain confident in our position there.
因此,我們仍然對我們在那裡的地位充滿信心。
And Jo, I'm so glad you asked about -- thank you for asking about Bydureon BCise because we're very excited about this.
Jo,我很高興你問到——感謝你問到 Bydureon BCise,因為我們對此感到非常興奮。
The GLP-1 category is growing very fast in the U.S. This device has been really well appreciated by physicians and patients.
GLP-1 類別在美國增長非常快。該設備非常受到醫生和患者的讚賞。
The feedback in the research that we did before launch and then in the early days of launch is that this is a very competitive device with the leader in the category.
我們在發布前和發布初期所做的研究反饋是,這是一款極具競爭力的設備,在同類產品中處於領先地位。
Very early days.
很早的時候。
We only launched in the middle of December so -- and there's been a lot of holidays.
我們只是在 12 月中旬推出,所以有很多假期。
So you're going to have to wait a few more weeks to start to see a clear position.
所以你將不得不再等幾週才能開始看到一個明確的位置。
But the feedback from, again, physicians and patients on Bydureon BCise is very positive.
但是,醫生和患者對 Bydureon BCise 的反饋還是非常積極的。
And we have adjusted our resourcing.
我們已經調整了我們的資源。
We've got a very significant sales and medical teams in the U.S. that are supporting both Farxiga and Bydureon, and so we're very excited about the prospects for Bydureon BCise in 2018.
我們在美國擁有一支非常重要的銷售和醫療團隊,他們同時支持 Farxiga 和 Bydureon,因此我們對 Bydureon BCise 在 2018 年的前景感到非常興奮。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
I think you can -- it's early days, you're right, Mark, but you can actually look at the NBRx share for BCise over the last 2, 3 weeks, and you will see that there's a very nice progression already even though we started promoting, in fact, in January, really.
我認為你可以——現在還處於早期階段,你是對的,馬克,但你實際上可以看看過去 2、3 週內 BCise 的 NBRx 份額,你會發現即使我們已經取得了非常好的進展實際上,真的是在一月份就開始宣傳了。
So the product itself have the potential and then the combination with Farxiga also has potential.
所以產品本身有潛力,然後與 Farxiga 的組合也有潛力。
As you know, we have very nice data for that combination.
如您所知,我們有關於該組合的非常好的數據。
Should we move to Alex at BMO?
我們應該轉到 BMO 的 Alex 嗎?
Alex is on the line.
亞歷克斯在線。
I think maybe Dave is waiting for a question.
我想 Dave 可能正在等待提問。
Tell him how good a job he's doing.
告訴他他做得有多好。
Usually, we talk about oncology the whole time.
通常,我們一直在談論腫瘤學。
But now, there's no oncology question.
但現在,沒有腫瘤學問題。
Alex, go ahead.
亞歷克斯,繼續。
Prakhar Agrawal
Prakhar Agrawal
This is Prakhar Agrawal on behalf of Alex Arfaei.
我是代表 Alex Arfaei 的 Prakhar Agrawal。
So 2 quick questions.
所以 2 個快速問題。
First, what has been the early physician feedback on Calquence?
首先,早期醫生對 Calquence 的反饋是什麼?
And secondly, have you conducted an interim OS analysis on MYSTIC since you announced the PFS result?
其次,自宣布 PFS 結果以來,您是否對 MYSTIC 進行了中期 OS 分析?
And lastly, when should we expect the Imfinzi PACIFIC results to be reflected in the sale of major market, specifically U.S. and Europe?
最後,我們什麼時候可以預期 Imfinzi PACIFIC 的業績會反映在主要市場(特別是美國和歐洲)的銷售中?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Well, so here is the answer to my -- a call for oncology question.
好吧,這就是我對腫瘤學問題的呼籲的答案。
So maybe, Sean, you can cover the MYSTIC and the PACIFIC question because, really, it's a regulatory question in terms of when do we get approval and when can we start promoting.
所以也許,肖恩,你可以討論 MYSTIC 和 PACIFIC 問題,因為實際上,這是一個監管問題,涉及我們何時獲得批准以及我們何時可以開始推廣。
And Dave could add some more color from a commercial viewpoint and also cover Calquence?
Dave 可以從商業角度添加更多顏色並涵蓋 Calquence 嗎?
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Yes.
是的。
So the interim question's pretty easy.
所以臨時問題很簡單。
It's very similar to answer that I gave on to Andrew's question about Forxiga.
這與我對安德魯關於 Forxiga 的問題的回答非常相似。
We have interims in the trials.
我們在試驗中有過渡期。
We do not disclose things about those interims, unless, of course, they're positive.
我們不會透露有關這些過渡時期的事情,當然,除非它們是積極的。
That's how PACIFIC turned out being disclosed for PFS, if you may recall.
如果您還記得的話,這就是 PACIFIC 為 PFS 披露的結果。
But the trials, it's important to recognize, are designed based on robust assumptions of clinically meaningful differences and designed to be the rightsize of the final analysis.
但是,重要的是要認識到,這些試驗是基於對具有臨床意義的差異的穩健假設而設計的,並且旨在成為最終分析的合適規模。
So if they exceed our expectations considerably, they can read out early.
因此,如果他們大大超出我們的預期,他們可以提前閱讀。
With regard to PACIFIC and the regulatory timing I gave -- I pretty much gave that in the -- actually, in the presentation.
關於 PACIFIC 和我給出的監管時間 - 我幾乎在 - 實際上,在演示中給出了。
So regulatory timing for the United States we anticipate in the first half of the year to receive approval for PACIFIC based upon the Priority Review designation for I'm calling major markets [in] Japan.
因此,我們預計美國的監管時間將在今年上半年獲得 PACIFIC 的批准,該批准基於我稱之為日本主要市場的優先審查指定。
And the EU, it will be by end of year 2018.
而歐盟,將在 2018 年底前完成。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Sean.
謝謝,肖恩。
David, maybe some additional color commercially on PACIFIC and then Calquence.
大衛,也許一些額外的顏色在 PACIFIC 上商業化,然後是 Calquence。
David Fredrickson - Executive VP & Global Head Oncology Business Unit
David Fredrickson - Executive VP & Global Head Oncology Business Unit
Sure.
當然。
So in terms of additional color on PACIFIC, in terms of from a commercial perspective, so we are very much getting ourselves ready for the PACIFIC launch, which we're anticipating, as we said, within the first half.
因此,就 PACIFIC 的附加顏色而言,從商業角度來看,我們正在為 PACIFIC 的發布做好充分準備,正如我們所說,我們預計將在上半年推出。
The majority of the utilization that we saw in the fourth quarter for Imfinzi was within lung cancer.
我們在第四季度看到的 Imfinzi 的大部分利用是在肺癌領域。
So obviously, we promote only within the bladder setting, but we see that there's enthusiasm within PACIFIC.
很明顯,我們只在膀胱環境中進行宣傳,但我們看到 PACIFIC 內部充滿熱情。
I think that if you take a look at the factors that lead into the speed with which you might think about the uptake for PACIFIC, obviously, the label is one element, and we await feedback from the FDA on where that will net out.
我認為,如果你看一下導致 PACIFIC 接受速度的因素,顯然,標籤是一個因素,我們等待 FDA 的反饋,說明它將在何處產生影響。
We studied in Stage III concurrent unresectable patients.
我們在 III 期並發不可切除患者中進行了研究。
The second is access.
二是接入。
We've certainly seen that access has been growing in terms of hospital access within the U.S. and formulary access.
我們當然已經看到,就美國境內的醫院准入和處方藥准入而言,准入一直在增長。
And I think that it speaks volumes to one of the reasons why getting onto the market with bladder was so important because it has allowed us to be able to have that formula access.
而且我認為這充分說明了膀胱進入市場如此重要的原因之一,因為它使我們能夠獲得該配方。
And then I think the last piece is the speed with which you expect to see adoption.
然後我認為最後一部分是您期望看到採用的速度。
I think that here, it's important to remember that the data for PACIFIC are certainly very exciting and unprecedented, but we also have a lot of education that we're going to need to do.
我認為在這裡,重要的是要記住 PACIFIC 的數據肯定是非常令人興奮和前所未有的,但我們也有很多我們需要做的教育。
And so I think that it's important also recognize that, today, there are no therapies that are used post-chemo radiotherapy in Stage III.
所以我認為重要的是要認識到,今天,在 III 期化療放療後沒有使用任何療法。
And so it's watch and wait is the competition.
所以它的觀察和等待是競爭。
So to educate physicians on that, this is different from you're using an agent today, and we're going to replace it with something better.
因此,為了就此對醫生進行教育,這與您今天使用的代理不同,我們將用更好的東西取而代之。
This is an education on this is a new way, a new treatment paradigm with the PACIFIC regimen.
這是關於這是一種新方法的教育,一種新的 PACIFIC 方案治療範例。
So I think that needs to be factored in as we think about the uptake.
因此,我認為在我們考慮採用率時需要考慮到這一點。
On Calquence, we've been really pleased with the progress that we've made in mantle cell lymphoma.
在 Calquence 上,我們對我們在套細胞淋巴瘤方面取得的進展感到非常高興。
We have a lean and mean sales force on this, which we think is appropriately sized for the size of the market that's there.
我們在這方面有一支精乾而平均的銷售隊伍,我們認為其規模適合那裡的市場規模。
But what we've seen with that is that, coming at the end of the year, we have aided awareness over 90% for the brand among our target audience, which is incredibly high considering we launched on the 31st of October.
但我們看到的是,到今年年底,我們已經幫助目標受眾對該品牌的認知度提高了 90% 以上,考慮到我們是在 10 月 31 日推出的,這個數字非常高。
That's a lot of progress and speaks to the work that we did there.
這是很大的進步,說明了我們在那裡所做的工作。
The intent to prescribe is over 60% among the physicians that we're speaking to.
在與我們交談的醫生中,有超過 60% 的人打算開處方。
And we estimate that, right now, about 1 in 5 new starts is being started on Calquence in MCL at the end of the year.
我們估計,到今年年底,大約五分之一的新項目將在 MCL 的 Calquence 上啟動。
So again, when you think about that, that's an 8-week launch period that included some holidays within there.
所以,再一次,當你想到這一點時,這是一個 8 週的發布期,其中包括一些假期。
We're pretty pleased with that progress.
我們對這一進展感到非常滿意。
James Daniel Gordon - Senior Analyst
James Daniel Gordon - Senior Analyst
James Gordon from JPMorgan.
摩根大通的詹姆斯戈登。
Two questions, please.
請教兩個問題。
One was on Tagrisso in China.
一個是在中國的 Tagrisso。
There was a comment about some initial reimbursement in some places.
在一些地方有關於一些初始報銷的評論。
What does that initial reimbursement look like?
最初的報銷是什麼樣的?
Is it very big price concessions to what we've seen in the West?
與我們在西方看到的相比,價格是否有很大的讓步?
and as you broaden reimbursement in China, do you think you'll have to make big price concessions?
隨著你們擴大在中國的報銷範圍,你們是否認為你們必須做出大幅度的價格讓步?
How's that playing out?
效果如何?
Also, in China, when do you think you might have a first-line approval?
另外,在中國,您認為什麼時候可能會獲得一線批准?
And could that require another step-up in price concessions?
這是否需要進一步提高價格優惠?
And if I could just squeeze another question, which will be on roxadustat.
如果我可以提出另一個問題,那就是 roxadustat。
So there's predialysis and dialysis.
所以有預透析和透析。
Where do you think the bigger hurdle is?
你認為更大的障礙在哪裡?
Which is tougher to get the mortality outcome you need?
哪個更難獲得您需要的死亡率結果?
And which is the bigger commercial opportunity?
哪個是更大的商業機會?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Maybe Sean could cover the roxa question and also the approval timing for first-line Tagrisso in China.
也許 Sean 可以討論 roxa 問題以及一線 Tagrisso 在中國的批准時間。
Let me just say that, in first line, it's going to be hard in the near term, right, because the cost is substantial.
我只想說,首先,短期內會很困難,對吧,因為成本很高。
In the second line, then you have a relatively good case to potentially get a reimbursement.
在第二行中,您有一個相對較好的案例可以得到報銷。
First line, it's harder.
第一行,更難。
And we have IRESSA there that is really doing very well.
我們那裡有 IRESSA,它確實做得很好。
Sean, do you want to cover the first line, and then Dave could cover the roxa.
Sean,你想覆蓋第一行嗎,然後 Dave 可以覆蓋 roxa。
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Roxa predialysis versus dialysis.
Roxa 透析前與透析。
So we don't have a time line we communicate for first-line approval in China.
因此,我們沒有在中國獲得一線批准的時間表。
In part, that has to do with the fact that there isn't really a PDUFA-like structure in the Chinese regulatory system.
在某種程度上,這與中國監管體系中實際上並沒有類似 PDUFA 的結構這一事實有關。
So you don't -- you submit, you get acceptance.
所以你不——你提交,你得到接受。
You don't necessarily know what the review cycle is going to be, so it's hard for us to communicate.
你不一定知道審核週期是怎樣的,所以我們很難溝通。
I will say it's the FDA definitely will be moving more quickly in the way that they're reviewing things.
我會說 FDA 肯定會以他們審查事物的方式更快地採取行動。
And I think Tagrisso second-line T790M was a brilliant example of that.
我認為 Tagrisso 二線 T790M 就是一個很好的例子。
So we're hopeful that we can engage them but can't give more guidance.
因此,我們希望能夠讓他們參與進來,但不能提供更多指導。
Roxa, right, so we have 2 main populations, which are predialysis and those already on dialysis.
Roxa,對,所以我們有兩個主要人群,即透析前人群和已經接受透析的人群。
It feels like there are 2 questions there.
感覺那裡有2個問題。
Is there a reason to think that the profile would be different safety-wise in one patient population versus another?
是否有理由認為一個患者群體與另一個患者群體在安全方面的概況會有所不同?
There isn't actually.
實際上沒有。
But what I can tell you is in a given period of time, it's easier to get a lot more events on the dialysis patients simply because they're at greater cardiovascular risk.
但我可以告訴你的是,在給定的時間段內,更容易在透析患者身上獲得更多的事件,僅僅是因為他們的心血管風險更高。
So we don't see a difference between the 2 mechanistically for what we would expect.
因此,對於我們所期望的,我們在機械上看不到兩者之間的差異。
We do believe that we will have more information on the dialysis patients by virtue of their higher risk going into trial.
我們確實相信,由於透析患者進入試驗的風險較高,我們將獲得更多關於透析患者的信息。
James Daniel Gordon - Senior Analyst
James Daniel Gordon - Senior Analyst
(inaudible) be the same.
(聽不清)是一樣的。
I was partly asking because if I understand correctly their different comparators, one, you're trying to show noninferiority to placebo, another one superiority to ESA, so whether that makes it -- whether the different comparator is a different hurdle?
我問的部分原因是,如果我正確理解了他們不同的比較器,一個,你試圖證明對安慰劑的非劣效性,另一個是對 ESA 的優勢,所以這是否成功——不同的比較器是否是一個不同的障礙?
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Yes, again, we don't mechanistically have any reason to believe that the comparators are a different hurdle.
是的,再一次,我們沒有任何理由相信比較器是一個不同的障礙。
It's more along the lines of what's the appropriate thing noninferior for something that doesn't -- isn't a treatment versus a drug with a current black box warning around this exact endpoint and wanting to show that you don't convey that risk.
它更多的是關於什麼是合適的非劣效的東西 - 不是一種治療與一種藥物,當前黑框警告圍繞這個確切的終點並希望表明你沒有傳達這種風險。
so that's really the only difference between the 2.
所以這真的是兩者之間的唯一區別。
David Fredrickson - Executive VP & Global Head Oncology Business Unit
David Fredrickson - Executive VP & Global Head Oncology Business Unit
So I think without getting into too much detail on the specifics of individual product pricing within China, what I would suggest that if you're looking for a good analog for how China prices move, I think Europe serves as a good one.
因此,我認為無需過多詳細了解中國境內個別產品定價的具體細節,我的建議是,如果你正在尋找中國價格走勢的良好模擬,我認為歐洲是一個很好的選擇。
So yes, subsequent indications do typically come with an expectation or a need for price concession.
所以是的,隨後的跡象通常伴隨著對價格讓步的期望或需要。
That typically comes in a way of free goods.
這通常以免費商品的方式出現。
I would use European analogs as you work forward.
當你繼續前進時,我會使用歐洲的類似物。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks Dave.
謝謝戴夫。
Mark, do you want to add something on roxa?
Mark,你想在 roxa 上添加一些東西嗎?
Mark Mallon - EVP-Global Product & Portfolio Strategy, Medical Affairs, Corporate Affairs & International West
Mark Mallon - EVP-Global Product & Portfolio Strategy, Medical Affairs, Corporate Affairs & International West
Yes.
是的。
I'm so pleased you asked about roxadustat, I mean, I think Sean gave you a sense of both the clinical program is working out and how to think about the outcomes.
我很高興你問到關於 roxadustat 的問題,我的意思是,我認為肖恩讓你了解了臨床計劃正在實施以及如何考慮結果。
I mean, commercially, we see very substantial opportunities both in the dialysis and the nondialysis.
我的意思是,在商業上,我們在透析和非透析領域都看到了非常可觀的機會。
There a different type of opportunity.
有不同類型的機會。
So dialysis, we think we're going to have, immediately, a very differentiated profile already.
所以透析,我們認為我們將立即擁有非常差異化的概況。
We know the ability to impact hemoglobin is very, very good from the data we've seen in China.
從我們在中國看到的數據,我們知道影響血紅蛋白的能力非常非常好。
If we can meet our expectations, we're going to have a cardiovascular product that has benefits there.
如果我們能夠滿足我們的期望,我們將擁有一種有益於心血管的產品。
And so then you added, moving from infusion to oral really substantial benefit.
然後你補充說,從輸液轉向口服確實有很大的好處。
In the predialysis, I mean, it's a huge opportunity, but there is a market-shaping and building effort that's going to require, which we are planning for.
在透析前,我的意思是,這是一個巨大的機會,但我們正在計劃需要市場塑造和建設工作。
A very small -- relatively small percentage of patients get treated for anemia today, right.
今天只有很少一部分患者接受貧血治療,對吧。
But basically elevated cardiovascular risk.
但基本上增加了心血管風險。
They're dealing with lot of actually symptoms from it.
他們正在處理它的許多實際症狀。
But there's not been reasonable options for these patients, so really, a huge opportunity there as well.
但是這些患者沒有合理的選擇,所以真的,那裡也是一個巨大的機會。
It's going take time to build that market because we've got to generate the evidence and educate physicians almost like what we are talking about in PACIFIC with the -- other than iron, most of these patients don't get any treatment, so really excited about the product.
建立這個市場需要時間,因為我們必須像我們在 PACIFIC 中談論的那樣收集證據並教育醫生——除了鐵之外,這些患者中的大多數沒有得到任何治療,所以真的對產品感到興奮。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
And again, synergies across the portfolio, I mean, if you look at the prescribers, nephrologists.
再一次,整個投資組合的協同作用,我的意思是,如果你看看開處方者、腎病學家。
We'll have Farxiga.
我們將有 Farxiga。
We'll have roxadustat.
我們會有 roxadustat。
Then you look at diabetologist, who will somehow have to play a role in this predialysis treatment.
然後你看看糖尿病學家,他們將以某種方式在這種透析前治療中發揮作用。
Of course, we have Farxiga.
當然,我們有 Farxiga。
We'll have roxadustat.
我們會有 roxadustat。
So really a strong synergy across.
所以真的是一個強大的協同作用。
Let's move to -- take an online question, Seamus at Leerink.
讓我們轉到——Leerink 的 Seamus 提出一個在線問題。
Go ahead, Seamus.
去吧,西默斯。
Seamus, are you there?
西莫,你在嗎?
We can't hear you.
我們聽不到你的聲音。
So maybe we return to the room.
所以也許我們回到房間。
Jack Scannell - Co-Head of Pharmaceuticals Equity Research and MD
Jack Scannell - Co-Head of Pharmaceuticals Equity Research and MD
Jack Scannell, UBS.
傑克·斯坎內爾,瑞銀。
I've got 17 questions, of which I'll ask 1. You, 4 or 5 years ago, published a real interesting paper that was a remarkably frank analysis of why R&D had been unsuccessful, perhaps, for AstraZeneca.
我有 17 個問題,我會問其中的一個。您在 4 或 5 年前發表了一篇非常有趣的論文,該論文非常坦率地分析了為什麼阿斯利康的研發可能不成功。
And you published the framework to try and make it better.
你發布了框架,試圖讓它變得更好。
And then about a month ago, you published another paper declaring victory saying the problem had been fixed.
然後大約一個月前,你發表了另一篇宣告勝利的論文,說問題已經解決了。
So my question is how easy would it be for other drug companies to read those papers and try and replicate what you guys claim you've done?
所以我的問題是,其他製藥公司閱讀這些論文並嘗試複製你們聲稱自己所做的事情有多容易?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Well, I'll ask Sean to cover this one, but I don't think we declared a victory.
好吧,我會請肖恩來報導這個,但我不認為我們宣布了勝利。
Sorry, if it sounds like this, that was not the intent.
抱歉,如果聽起來像這樣,那不是本意。
I think many who leads the (inaudible) were simply sharing some of the learnings and experience we've had.
我認為許多領導(聽不清)的人只是在分享我們的一些知識和經驗。
And of course, everybody's very proud of the progress we've made, but there was no intent to declare victory.
當然,每個人都為我們取得的進步感到非常自豪,但並沒有宣布勝利的意圖。
Sean, do you want to cover this?
肖恩,你想報導這個嗎?
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Sure, I'm happy to.
當然,我很樂意。
I think that's exactly right.
我認為這是完全正確的。
So this is our 5 Rs paper and 2 elements to it.
所以這是我們的 5 Rs 紙和 2 個元素。
One is the declaration of victory.
一是勝利宣言。
I think from going to single-digit -- mid-single-digit percent success of a candidate through to getting a drug to what looks like 20% in our more recent experience, this is great progress.
我認為,從候選人的個位數——中等個位數的成功率到獲得藥物到我們最近的經驗中看起來像 20% 的成功率,這是一個很大的進步。
It's not exactly declaring victory, right, because then 80% of the time you still fail.
這不完全是宣告勝利,對吧,因為 80% 的時候你仍然會失敗。
So -- but we do feel like we're doing a lot better, and that that's playing out now in how our R&D investment is realizing into launches and market opportunities.
所以——但我們確實覺得我們做得好多了,這在我們的研發投資如何實現發布和市場機會方面正在發揮作用。
The question was, I think, are we enabling competition by publishing these kinds of things.
我認為,問題是我們是否通過發布這些東西來促進競爭。
Jack Scannell - Co-Head of Pharmaceuticals Equity Research and MD
Jack Scannell - Co-Head of Pharmaceuticals Equity Research and MD
(inaudible) transferable to the...
(聽不清)可轉移到...
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Sean Bohen - Chief Medical Officer and EVP of Global Medicines Development
Yes.
是的。
It's interesting.
這真有趣。
I think the lessons are quite transferable, to be perfectly honest.
老實說,我認為這些課程是可以轉移的。
And in some respects, there are things we have as an industry have known for a long time.
在某些方面,有些事情我們作為一個行業已經知道了很長時間。
If you ask what's different about it, it's not knowing them that's quite so complicated as it is applying them objectively and consistently and not allowing hope to sway you in a place for one of those factors that means that you've moved away from being rigorous.
如果你問它有什麼不同,那就是不知道它們是如此復雜,因為它是客觀和一致地應用它們,並且不允許希望因為其中一個因素而影響你,這意味著你已經擺脫了嚴格.
That is not so easy to do, it turns out.
事實證明,這並非易事。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
I would only add that all of us can read the same cooking recipe.
我只想補充一點,我們所有人都可以閱讀相同的烹飪食譜。
Doesn't make us a world-class chef, right.
不會讓我們成為世界級的廚師,對吧。
So there's that.
就是這樣。
I mean, having a process and a structure of the approach is real useful, but then you really need to make sure you have great people and then really people who -- in a culture that sustain this and an approach that really is really creative and innovative.
我的意思是,擁有一個過程和方法的結構是非常有用的,但是你真的需要確保你有優秀的人,然後是真正的人——在一種支持這一點的文化中,一種真正具有創造性和創造性的方法。創新的。
So let's move back to online.
那麼讓我們回到線上。
Mark Purcell at Redburn.
馬克珀塞爾在雷德本。
Mark, go ahead.
馬克,繼續。
Mark Douglas Purcell - Research Analyst
Mark Douglas Purcell - Research Analyst
Great.
偉大的。
I just -- a couple of clarification points, actually, going back to what Jo was asking on gross margin.
實際上,我只是 - 幾個澄清點,回到喬對毛利率的要求。
I feel a bit confused by the progression in Q4, and there may be some underlying impact.
我對第四季度的進展感到有點困惑,可能會有一些潛在的影響。
So if we assume products cost $250 million, $300 million, that would, obviously, have a very high gross margin contribution, be very positive to the gross margin Q4, which came in at 79.4%.
因此,如果我們假設產品成本為 2.5 億美元、3 億美元,那顯然會產生非常高的毛利率貢獻,對 79.4% 的第四季度毛利率非常有利。
So were there any offsetting factors in there such as your MSD payments and the (inaudible) payments, which you mentioned?
那麼那裡是否有任何抵消因素,例如您提到的 MSD 付款和(聽不清)付款?
And can you help us understand sort of the moving parts there?
你能幫助我們了解那裡的活動部件嗎?
I think the FX has an impact.
我認為外匯有影響。
But the accruals impact the MSD payments, whether those are an accrual of the MSD payments, which had a diluted effect?
但應計費用會影響 MSD 付款,這些是否是 MSD 付款的應計費用,具有稀釋效果?
And then secondly, on FX.
其次,在 FX 上。
I was a little bit confused by the guidance FX having a minimal impact on earnings in 2018.
我對外匯指導對 2018 年收益的影響微乎其微感到有點困惑。
If I followed your guidance, just using the 5 main currencies that you have in your press release, using the (inaudible) impact of currency on sales would be 2%; earnings, 3%.
如果我遵循您的指導,僅使用您在新聞稿中使用的 5 種主要貨幣,則使用貨幣對銷售額的(聽不清)影響為 2%;收益,3%。
So that impact is consistent with your guidance on sales but not on EPS.
因此,這種影響與您對銷售的指導一致,但與 EPS 不一致。
If I use spot again, just using the 5 main invoicing currencies and not the other component, the impact of currency was 3% on sales and 5% on earnings.
如果我再次使用現貨,只使用 5 種主要計價貨幣而不是其他成分,則貨幣對銷售額的影響為 3%,對收益的影響為 5%。
so are there any other factors which I'm missing which dilute the effect -- positive effect of the weakening dollar or the hedging losses or anything like that.
還有我遺漏的任何其他因素會稀釋影響 - 美元疲軟或對沖損失或類似因素的積極影響。
Some clarification would be great.
一些澄清會很好。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks Mark.
謝謝馬克。
Marc, can you try to cover them?
馬克,你能試著掩蓋他們嗎?
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
So we try to mention some more on the gross margin.
因此,我們嘗試在毛利率上多提一些。
What I said earlier on that if you look at the second half of 2017, it should provide you a good guide for what the level of gross margin will be in 2018.
我之前說過,如果你看一下 2017 年下半年,它應該會為你提供一個很好的指南,讓你了解 2018 年的毛利率水平。
It is also in our press release.
它也在我們的新聞稿中。
We deduct from gross margin the profit-sharing we provide Merck as well as we do for Circassia, so we have indicated what goes in or comes out of the gross margin.
我們從毛利率中扣除了我們為默克提供的利潤分享以及我們為 Circassia 所做的,因此我們已經指出了毛利率的進出。
So this is going to be one factor also for 2018.
所以這也將成為 2018 年的一個因素。
There's another factor that you need to consider that explain that, in comparison to the first half of 2017, the gross margin is lower, we have larger expenditures and depreciation in the biopharmaceutical capabilities.
還有一個你需要考慮的因素解釋說,與 2017 年上半年相比,毛利率較低,我們在生物製藥能力方面有更大的支出和折舊。
So this is why the level of gross margin has declined.
所以這就是毛利率水平下降的原因。
You obviously have mix of products in various geographies.
您顯然在不同地區混合了多種產品。
But if I put this aside, the 2 main factors are the profit margin given to the partners -- this is one -- and the more expensive production capabilities for the biopharm product.
但如果我把這個放在一邊,兩個主要因素是給予合作夥伴的利潤率——這是一個——以及生物製藥產品更昂貴的生產能力。
These are the 2 main factors.
這是2個主要因素。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Marc.
謝謝,馬克。
So I think we'll have to stop here because we're out of time, unfortunately.
所以我認為我們必須到此為止,很遺憾,我們已經沒時間了。
I'm sorry.
對不起。
If you have any more questions, please send them to IR team.
如果您有任何問題,請將它們發送給 IR 團隊。
Let me just close by thanking you all for your interest and your great questions and just kind of repeating what I said a bit earlier is we are at the stage where the pipeline is delivered.
最後,讓我感謝大家的興趣和提出的重要問題,並重複我之前說過的話,我們正處於交付管道的階段。
We are now full commercial launch mode.
我們現在是完整的商業發布模式。
We have 7 products that are either in launch mode or growing very, very fast so that explains we need to resource them, but that also drives very substantial growth rate.
我們有 7 種產品要么處於啟動模式,要么增長非常非常快,這說明我們需要為它們提供資源,但這也推動了非常可觀的增長率。
And on top of those 7 global products that are in true launch mode, we have China that is really material for us.
除了這 7 款處於真正發布模式的全球產品之外,我們還有對我們來說非常重要的中國。
For many companies, China is not material.
對於許多公司來說,中國並不重要。
For us, it is material, very material and growing very rapidly, and it's our second-largest market globally.
對我們來說,它很重要,非常重要,而且增長非常迅速,而且它是我們在全球的第二大市場。
So with that, I will, again, thank you and wish you a good weekend.
因此,我將再次感謝您並祝您週末愉快。
Thank you very much.
非常感謝你。