AstraZeneca PLC (AZN) 2018 Q3 法說會逐字稿

Good afternoon Europe, and good morning to the U.S. Welcome, ladies and gentlemen, to AstraZeneca's year-to-date and Q3 2018 results.

歐洲下午好，美國早上好。女士們，先生們，歡迎來到阿斯利康（AstraZeneca）年初至今和 2018 年第三季度的業績。

Before I hand over to AstraZeneca, I'd like to read the Safe Harbor statement.

在我移交給阿斯利康之前，我想閱讀安全港聲明。

The company intends to utilize the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995.

公司打算利用 1995 年美國私人證券訴訟改革法案的安全港條款。

Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca.

本次電話會議的參與者可能會就阿斯利康的運營和財務業績做出前瞻性陳述。

Although we believe our expectations are based on reasonable assumptions, by their very nature, forward-looking statements involve risks and uncertainties and may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements.

儘管我們認為我們的預期是基於合理的假設，但就其本質而言，前瞻性陳述涉及風險和不確定性，並且可能受到可能導致實際結果與這些前瞻性陳述所表達或暗示的結果存在重大差異的因素的影響。

Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call.

在本次電話會議上做出的任何前瞻性陳述都反映了本次電話會議時可獲得的知識和信息。

The company undertakes no obligation to update forward-looking statements.

公司不承擔更新前瞻性陳述的義務。

Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation and webcast.

另請仔細閱讀本演示文稿和網絡廣播附帶的幻燈片中的前瞻性聲明免責聲明。

I will now hand the conference over to Chief Executive Officer, Pascal Soriot.

我現在將把會議交給首席執行官 Pascal Soriot。

Hello, everyone.

大家好。

It's Pascal Soriot here.

我是 Pascal Soriot。

Welcome to our year-to-date and third quarter conference call and our webcast for investors and analysts.

歡迎來到我們年初至今和第三季度的電話會議以及我們面向投資者和分析師的網絡廣播。

We have people on the phone and the webcast.

我們有人接聽電話和網絡廣播。

The presentation, as always, is available on astrazeneca.com for you to download.

一如既往，該演示文稿可在 astrazeneca.com 上獲取，供您下載。

So please turn to Slide 2. This is the usual Safe Harbor Statement.

所以請轉到幻燈片 2。這是通常的安全港聲明。

As a reminder, today, we'll be making comments on our financial performance using core reporting metrics and at constant exchange rates, CER, which are both non-GAAP measures.

提醒一下，今天，我們將使用核心報告指標和固定匯率 CER 對我們的財務業績發表評論，這都是非 GAAP 指標。

All numbers we refer to million U.S. dollars, and growth rates will be at CER and for the year-to-date, end of September period of 2018, unless otherwise stated.

除非另有說明，否則我們指的所有數字均以百萬美元為單位，增長率將按 CER 計算，並且是截至 2018 年 9 月底的年初至今。

Please turn to Slide 3. We plan to spend about 45 minutes on the presentation, and then we'll keep time for Q&A.

請翻到幻燈片 3。我們計劃用大約 45 分鐘的時間進行演示，然後留出時間進行問答。

(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。

(Operator Instructions).

（操作員說明）。

Today, I'm joined, as always, by Dave Fredrickson, our EVP of Oncology; Mark Mallon, our EVP for Global Products and Portfolio Strategy, Medical Affairs and Corporate Affairs; Marc Dunoyer, our Chief Financial Officer; and Sean Bohen, our EVP of Global Medicines Development and our Chief Medical Officer.

今天，我們的腫瘤學執行副總裁 Dave Fredrickson 一如既往地加入了我的行列； Mark Mallon，我們的全球產品和投資組合戰略、醫療事務和公司事務執行副總裁；我們的首席財務官 Marc Dunoyer；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 and that -- these are the topics we plan to cover today.

請轉到幻燈片 4。這是議程，而且這些是我們今天計劃討論的主題。

In addition, Sean will spend a little bit more time on the year-end update on the late-stage pipeline and a look forward to 2019 and '20 where our pipeline news flow remains busy and very important.

此外，Sean 將花更多時間在後期管道的年終更新上，並展望 2019 年和 20 年，我們的管道新聞流仍然繁忙且非常重要。

Turn to Slide 5. I'm really pleased to report that AstraZeneca returned to sustainable growth in Q3 and cumulatively year-to-date.

轉到幻燈片 5。我很高興地報告阿斯利康在第三季度和今年迄今累計恢復了可持續增長。

This is really a major milestone for us, for the entire management team, for the company as a whole and for every one of our colleague around the world making this possible by their dedicated work for patients.

對於我們、整個管理團隊、整個公司以及我們在世界各地的每一位同事來說，這確實是一個重要的里程碑，他們通過為患者盡心盡力的工作使這一切成為可能。

Our main therapy area of Oncology, New CVRM and the main therapy area of Respiratory combined grew by 19% year-to-date and 27% in the third quarter.

我們的主要治療領域腫瘤、新 CVRM 和呼吸系統的主要治療領域今年迄今增長了 19%，第三季度增長了 27%。

Medicines outside our focus continued to decline, supporting the ongoing pipeline and now also top-line-driven transformation.

我們關注之外的藥物繼續下降，支持正在進行的管道，現在也支持頂線驅動的轉型。

Please turn to Slide 6. Importantly, beyond the fast growth, accelerating growth of the new products, you can see that the older products that have been declining are becoming smaller.

請轉到幻燈片 6。重要的是，除了新產品的快速增長、加速增長之外，您可以看到一直在下降的老產品正在變得越來越小。

Over the past few years, we have reduced the contribution from older medicines in decline and off-patent.

在過去的幾年裡，我們減少了下降和專利到期的老藥的貢獻。

But we've increased, of course, the exposure to high-growth medicines in our therapy areas for the future.

但是，當然，我們在未來的治療領域增加了對高增長藥物的接觸。

Oncology, New CVRM and Respiratory combined now make up more than 70% of the total sales.

腫瘤科、新 CVRM 和呼吸科合計佔總銷售額的 70% 以上。

The other medicines remain relatively stable in the Emerging Markets, and the other medicines outside the Emerging Markets are declining.

其他藥物在新興市場保持相對穩定，而新興市場以外的其他藥物則呈下降趨勢。

But now they make up only 15% of our total sales and they're starting to bottom out.

但現在它們僅占我們總銷售額的 15%，並且開始觸底反彈。

Unlike in the past, the new medicines in our 3 main key areas are now more than able to compensate, and we see sustainable growth in the total portfolio going forward.

與過去不同，我們 3 個主要關鍵領域的新藥現在足以彌補，我們看到未來總產品組合的可持續增長。

On top of it, of course, the new products are gaining momentum as we launch in more markets and with more indications.

當然，最重要的是，隨著我們在更多市場推出新產品並獲得更多適應症，新產品正在獲得動力。

I will now cover the details of the quarter and the reason for optimism.

我現在將介紹本季度的細節和樂觀的原因。

Please turn to Slide 7. If you look at the details, our sales increased by 2% and by 9% in the quarter, 2% year-to-date.

請轉到幻燈片 7。如果您查看詳細信息，我們的銷售額在本季度增長了 2% 和 9%，年初至今增長了 2%。

We saw strong performance by the new medicines that are up 76% in China.

我們看到新藥表現強勁，在中國增長了 76%。

And it is less offset now, as I said earlier by divestments and by generics, the adverse impact is more limited.

正如我之前所說的撤資和仿製藥，它現在抵消得更少了，不利影響更加有限。

Total revenue declined by 8%, reflecting lower externalization coming in the third quarter.

總收入下降了 8%，反映出第三季度外部化程度較低。

On externalization, we expect the fourth quarter to improve.

在外部化方面，我們預計第四季度會有所改善。

As a reminder, some new deals may also come as other operating income.

提醒一下，一些新交易也可能來自其他營業收入。

So the new medicines that are important to our future added more than $1.8 billion in incremental sales versus the year-to-date period last year and they grew by 76%.

因此，與去年同期相比，對我們的未來很重要的新藥增加了超過 18 億美元的銷售額，增長了 76%。

Oncology was up 44%, with Lynparza, Tagrisso and Imfinzi all performing very well.

腫瘤學增長了 44%，Lynparza、Tagrisso 和 Imfinzi 都表現非常好。

New CVRM was up by 12%, with Brilinta, up 18%; and Farxiga, up 32%.

新 CVRM 上漲 12%，Brilinta 上漲 18%；和 Farxiga，增長 32%。

Respiratory was up by 2%, also a return to growth.

呼吸上升了 2%，也恢復了增長。

Symbicort remains in a competitive environment.

Symbicort 仍然處於競爭激烈的環境中。

We experienced growth in volume, but negative price pressures.

我們經歷了銷量增長，但價格壓力下降。

However, Fasenra and Pulmicort are now doing extremely well, in particular Fasenra.

然而，Fasenra 和 Pulmicort 現在做得非常好，尤其是 Fasenra。

We'll cover that later.

我們稍後會介紹。

It's doing incredibly well.

它做得非常好。

Finally, the Emerging Markets continued with a strong growth, driven by China, which is up 27% year-to-date and 32% in the quarter.

最後，在中國的推動下，新興市場繼續強勁增長，年初至今增長 27%，本季度增長 32%。

Core EPS achieved $1.88 year-to-date, in line with our progression this year and the level of externalization.

年初至今，核心每股收益達到 1.88 美元，符合我們今年的進展和外部化水平。

And our guidance is on track for the year.

我們的指導方針在今年步入正軌。

Please turn to Slide 8. We continued to make progress with our pipeline, which remains as important as ever to drive our sales growth in the future.

請轉到幻燈片 8。我們繼續在管道方面取得進展，這對於推動我們未來的銷售增長仍然一如既往地重要。

There were a number of milestones for Lynparza, including the first approval in China and also another milestone important one was the presentation of the first-line ovarian results in BRCA mutant.

Lynparza 有多個里程碑，包括在中國的首次批准，還有一個里程碑式的重要事件是 BRCA 突變體一線卵巢結果的展示。

Approvals were also achieved for Tagrisso in Japan, Imfinzi in the EU, Lumoxiti in the U.S. Lumoxiti, which is treating a rare disease, later entered a collaboration with Innate.

日本的Tagrisso、歐盟的Imfinzi、美國的Lumoxiti也獲得了批准。治療罕見病的Lumoxiti後來與Innate進行了合作。

The DECLARE trial with Farxiga delivered positive data and met the primary endpoint of a reduced cardiovascular risk on the composite endpoint of hospitalization for heart failure or cardiovascular death.

使用 Farxiga 的 DECLARE 試驗提供了積極的數據，並達到了主要終點，即因心力衰竭或心血管死亡住院的複合終點降低心血管風險。

In Respiratory, we also achieved a number of milestones, including the first submission for closed tripod-inhalation medicine PT010 for COPD and also a number of other milestones for Symbicort, Duaklir and Bevespi.

在呼吸方面，我們也取得了一些里程碑，包括首次提交用於 COPD 的封閉式三腳架吸入藥物 PT010，以及 Symbicort、Duaklir 和 Bevespi 的其他一些里程碑。

So in many ways, our Respiratory business has also moved up a gear.

因此，在許多方面，我們的呼吸業務也取得了進步。

Unfortunately, and this is the kind of business we are in, sometimes we experience setbacks.

不幸的是，這就是我們所從事的業務，有時我們會遇到挫折。

Anifrolumab didn't make the primary endpoint in systemic lupus.

Anifrolumab 沒有成為系統性狼瘡的主要終點。

It is disappointing for patients.

這對患者來說是令人失望的。

It is disappointing for us, of course, but that is what we do.

當然，這對我們來說令人失望，但這就是我們所做的。

We take calculated risks on a variety of products in our pipeline.

我們對我們管道中的各種產品進行了計算風險。

If we turn to Slide 9. When we set out the new strategy a few years back, not everyone believed that we could return to growth.

如果我們轉到幻燈片 9。幾年前我們制定新戰略時，並不是每個人都相信我們可以恢復增長。

Hopefully, with today's results, it's clear that we've achieved an important inflection point.

希望今天的結果表明我們已經達到了一個重要的轉折點。

If you look at the graph here on the left-hand side, we've been really in sales decline since 2012.

如果您看一下左側的圖表，我們的銷售額自 2012 年以來就一直在下降。

And in fact, I'm often reminded that we've been in sales decline since 2010, driven by the final expiries of very large products, Crestor, Nexium, Seroquel and a few others.

事實上，我經常被提醒，自 2010 年以來，我們的銷售額一直在下降，這是受非常大的產品、Crestor、Nexium、Seroquel 和其他一些產品的最終到期影響。

And for the first time now, we experienced a very strong quarter as you can see here.

正如您在這裡看到的那樣，我們現在第一次經歷了一個非常強勁的季度。

So it is clearly an important inflection point for the company.

因此，這顯然是公司的一個重要轉折點。

In the coming quarters and the years, we'll make it sustainable.

在接下來的幾個季度和幾年裡，我們將使它可持續發展。

So we are now back to growth, and we have suddenly, clearly a long runway in term of growth over the next few years.

所以我們現在恢復了增長，而且在未來幾年的增長方面，我們突然之間顯然有很長的路要走。

As we said in July, sales growth this year would be weighted towards the second half of the year, so more growth in the third quarter.

正如我們在 7 月份所說，今年的銷售增長將集中在下半年，因此第三季度的增長會更多。

There would be a little bit less in the fourth quarter because we will be comparing the fourth quarter to a very tough fourth quarter last year where we had a couple of one-offs, gross-to-net adjustments in Q4 2017.

第四季度會少一些，因為我們將第四季度與去年非常艱難的第四季度進行比較，我們在 2017 年第四季度進行了幾次一次性的毛淨調整。

So a bit of a tougher comparison in Q4.

因此，在第四季度進行了一些更嚴格的比較。

But with 9% sales growth in the third quarter and 2% year-to-date, we are completely on track with the guidance for low single-digit growth rate in sales for the full year.

但由於第三季度銷售額增長 9%，年初至今銷售額增長 2%，我們完全按照全年銷售額低個位數增長率的指引走上正軌。

Please turn to Slide 10.

請轉到幻燈片 10。

If we go one step deeper and we look at the individual medicines, it is really nice to see that the performance of these new products, which in total added more than $1.8 billion in incremental sales versus last year and collectively grew by 76%.

如果我們更深入地研究單個藥物，我們會很高興看到這些新產品的表現，與去年相比，這些新產品的銷售額總計增加了 18 億美元，總體增長了 76%。

Tagrisso, as before, is the main contributor.

和以前一樣，塔格里索是主要貢獻者。

And it's important to point out here that on a run-rate basis, Tagrisso is now a $2 billion product, growing rapidly, followed by Imfinzi.

在這裡必須指出，按運行率計算，Tagrisso 現在是一個價值 20 億美元的產品，增長迅速，其次是 Imfinzi。

And here, I would say that Imfinzi is reaching the stage where it will be a, on a run-rate basis, $1 billion product, so very fast ramp-up.

在這裡，我要說的是，Imfinzi 正處於按運行率計算將成為 10 億美元產品的階段，因此增長速度非常快。

Farxiga is growing very nicely.

Farxiga 長得很好。

Lynparza is doing well.

Lynparza 表現良好。

Fasenra is doing well.

Fasenra 做得很好。

Brilinta continues to grow.

Brilinta 繼續增長。

So really pleasing sales development for our new medicines, and we are expecting further growth over the coming quarters and years.

我們新藥的銷售發展非常令人高興，我們預計未來幾個季度和幾年將進一步增長。

So if you turn to Slide 11, looking at product sales across our main therapy areas.

因此，如果您轉到幻燈片 11，查看我們主要治療領域的產品銷售情況。

Again, we are back to growth, including in Respiratory.

再一次，我們恢復了增長，包括在呼吸領域。

Let me share a few highlights here.

讓我在這里分享一些亮點。

Oncology, surpassing $1.5 billion in the quarter, grew 44%.

腫瘤學在本季度超過 15 億美元，增長了 44%。

Probably the fastest-growing diversified Oncology franchise of any company at the moment and making up close to 1/3 of AstraZeneca.

可能是目前所有公司中增長最快的多元化腫瘤專營權，佔阿斯利康的近 1/3。

New CVRM is currently made up of Brilinta, diabetes and Lokelma, and in the future, roxadustat.

新的CVRM目前由Brilinta、diabetes和Lokelma組成，未來將由roxadustat組成。

Collectively, this product grew -- products grew by 12% to now more than $1 billion in the quarter.

總的來說，該產品在本季度增長了 12%，目前已超過 10 億美元。

Respiratory was up by 2%, but grew by 5% in the quarter.

呼吸系統增長了 2%，但本季度增長了 5%。

Growth, of course, is impacted negatively by the price pressure on Symbicort, but Fasenra and Pulmicort were now more than able to offset that.

當然，增長受到 Symbicort 價格壓力的負面影響，但 Fasenra 和 Pulmicort 現在完全能夠抵消這一影響。

We continue to be very pleased by the market uptake of Fasenra and the ongoing launch.

我們繼續對 Fasenra 的市場接受度和持續推出感到非常高興。

We'll talk more about that a little later.

我們稍後會詳細討論。

Other medicines were down by 23%, reflecting the loss of exclusivity for Crestor in the EU and Japan, plus the effect of divestments.

其他藥物下降了 23%，反映出 Crestor 在歐盟和日本失去了獨占權，加上撤資的影響。

This line will remain in some decline as we focus our efforts on the main therapy areas, but the impact of the decline here will become more and more manageable moving forward.

隨著我們將精力集中在主要治療領域，這條線將保持一定程度的下降，但未來下降的影響將變得越來越可控。

And finally, and importantly, the Emerging Markets delivered a very, very strong performance, with 12% growth, China growing 27%, and in particular, China growing 32% in the quarter to almost $1 billion in the quarter 3. So very, very strong performance in China.

最後，重要的是，新興市場表現非常非常強勁，增長了 12%，中國增長了 27%，尤其是中國在第三季度增長了 32%，達到近 10 億美元。非常，在中國的表現非常強勁。

Before I hand over to Dave, my sincere thanks to every colleague in AstraZeneca who is working very hard to realize this inflection point in sales and the return to growth and the benefit we bring to patients in need all over the world.

在我交給戴夫之前，我衷心感謝阿斯利康的每一位同事，他們非常努力地工作，以實現銷售的拐點和恢復增長，以及我們為全世界有需要的患者帶來的利益。

Over to you, Dave, for the Oncology review.

交給你了，戴夫，關於腫瘤學的評論。

Great.

偉大的。

Thanks, Pascal.

謝謝，帕斯卡。

I want to take an opportunity to update you on performance of our new generation of medicines.

我想藉此機會向您介紹我們新一代藥物的最新性能。

We'll start with oncology, and then I'll hand it over to Mark Mallon, who'll go through a summary of CVRM, Respiratory and Emerging Markets.

我們將從腫瘤學開始，然後我將把它交給 Mark Mallon，他將對 CVRM、呼吸系統和新興市場進行總結。

If we could turn to Slide 13.

如果我們可以轉到幻燈片 13。

We're really happy to announce that total Oncology is now up to 28% of our total product sales, and as Pascal mention, it's now growing at 44%.

我們真的很高興地宣布，腫瘤科產品的總銷售額現在高達我們產品總銷售額的 28%，正如 Pascal 提到的那樣，它現在正以 44% 的速度增長。

The 4 new medicines delivered $1.2 billion in incremental sales versus the same period of 2017, and that was with continued growth coming from Lynparza, while also Tagrisso and Imfinzi continued their launches in their new indications in first-line EGFR mutated non-small cell lung cancer and unresectable Stage III non-small cell lung cancer, respectively.

與 2017 年同期相比，這 4 種新藥的銷售額增加了 12 億美元，這得益於 Lynparza 的持續增長，同時 Tagrisso 和 Imfinzi 也繼續推出一線 EGFR 突變非小細胞肺的新適應症癌症和不可切除的 III 期非小細胞肺癌。

We continue to see encouraging uptake of Calquence in the smaller mantle cell lymphoma indication as we prepare for that larger chronic lymphocytic leukemia indication with pivotal Phase III readouts coming next year.

我們繼續看到 Calquence 在較小的套細胞淋巴瘤適應症中的令人鼓舞的吸收，因為我們為明年即將到來的關鍵 III 期讀數準備更大的慢性淋巴細胞白血病適應症。

As for our legacy business, which I won't talk more about after this slide, Faslodex trajectory has maintained as the expanded labels and combinations with CDK4/6 inhibitors start to take effect.

至於我們的傳統業務，我不會在這張幻燈片後多談，隨著擴展的標籤和與 CDK4/6 抑製劑的組合開始生效，Faslodex 軌跡一直保持不變。

If we could turn now to Slide 14.

如果我們現在可以轉到幻燈片 14。

On Lynparza, we saw ongoing progress with sales of $438 million in the year with growth across all of our regions as we continue to roll out the broader label in ovarian cancer and the breast indication in the U.S. and in Japan.

在 Lynparza 方面，隨著我們繼續在美國和日本推出更廣泛的卵巢癌和乳腺適應症標籤，我們看到了今年銷售額 4.38 億美元的持續進展，我們所有地區的銷售額都在增長。

In the U.S., sales were $233 million for the year where Lynparza continues to be the leading medicine in the PARP inhibitor class as measured by total prescription volumes in this very competitive market.

在美國，按照這個競爭激烈的市場中的總處方量衡量，Lynparza 繼續成為 PARP 抑製劑類藥物中的領先藥物，這一年的銷售額為 2.33 億美元。

Quarter-on-quarter, sequential sales were impacted by inventory in the U.S. as we withdrew capsules from the market, but the underlying demand was strong with over 10% growth.

隨著我們從市場上撤回膠囊，環比銷售額受到美國庫存的影響，但潛在需求強勁，增長率超過 10%。

Increase in demand came from the all-comers label in second-line ovarian cancer as well as from the emerging breast cancer indication.

需求的增加來自二線卵巢癌的全能標籤以及新興的乳腺癌適應症。

And as you would expect, we see the majority of use in ovarian with emerging use within breast cancer.

正如您所預料的那樣，我們看到大多數藥物用於卵巢癌，而乳腺癌中也出現了新的應用。

Within Europe, sales were robust at $137 million year-to-date, up 37% versus the prior year, reflecting increase in BRCA testing rates as we roll out additional launches across Europe and secure reimbursement in several markets with the inclusion of the broader EU ovarian tablet label.

在歐洲，今年迄今的銷售額強勁，達到 1.37 億美元，比上一年增長 37%，這反映了 BRCA 測試率的提高，因為我們在歐洲推出更多產品，並在包括更廣泛的歐盟在內的多個市場獲得報銷卵巢片劑標籤。

Japan is off to a very nice start following the second quarter launches in ovarian and breast cancer and now has $25 million in sales year-to-date.

在第二季度推出卵巢癌和乳腺癌藥物後，日本有了一個非常好的開端，今年迄今的銷售額已達到 2500 萬美元。

We also see encouraging signs in China, which Pascal had mentioned we launched in the third quarter, and we are the first PARP inhibitor contributing to the $33 million in the Emerging Markets sales.

我們在中國也看到了令人鼓舞的跡象，Pascal 曾提到我們在第三季度推出了該產品，我們是第一個貢獻新興市場 3300 萬美元銷售額的 PARP 抑製劑。

The ongoing collaboration with our partner Merck progresses in the field force and beyond, and we continue to look forward to an exciting next few quarters of delivery for what we believe is the leading PARP inhibitor.

與我們的合作夥伴默克公司的持續合作在現場和其他方面取得了進展，我們繼續期待我們認為領先的 PARP 抑製劑在接下來的幾個季度中令人興奮的交付。

So if we could, please turn now to Slide 15.

如果可以的話，請現在轉到幻燈片 15。

Now turning to our lung cancer portfolio and starting with Tagrisso, which is the #1 medicine in the Oncology portfolio and the company's third-largest selling medicine.

現在轉向我們的肺癌產品組合，從 Tagrisso 開始，它是腫瘤產品組合中排名第一的藥物，也是公司第三大銷售藥物。

Tagrisso demonstrated continued growth of 91% with $1.2 billion in sales in the year, year-to-date and that's as the first-line label launches start to take effect.

今年迄今為止，Tagrisso 的銷售額持續增長 91%，銷售額為 12 億美元，而這正是一線標籤發布開始生效的時候。

Tagrisso, as Pascal mentioned, is now annualizing at $2 billion.

正如 Pascal 提到的那樣，Tagrisso 現在的年收入為 20 億美元。

The U.S. exhibited good growth with sales of $580 million as we continue the first-line launch.

隨著我們繼續一線推出，美國表現出良好的增長，銷售額達到 5.8 億美元。

And in the U.S., Tagrisso has now achieved approximately 60% new patient share in the first-line indication.

在美國，Tagrisso 目前已在一線適應症中獲得約 60% 的新患者份額。

This is up from the 50% that we commented on last quarter.

這高於我們上個季度評論的 50%。

And it is starting to now become implemented as standard of care, and further, we saw reinforcement for the recent inclusion on the NCCN guidelines as Tagrisso is the preferred regimen in Category 1.

它現在開始作為護理標準實施，而且，我們看到最近納入 NCCN 指南的強化，因為 Tagrisso 是第 1 類的首選方案。

Europe demonstrated a strong year-to-date with $222 million in year-to-date sales and growth of 68%.

歐洲年初至今表現強勁，年初至今銷售額為 2.22 億美元，增長率為 68%。

This medicine is now reaching more patients in the various countries across this region.

該藥物現在正在惠及該地區各個國家的更多患者。

And we continue to see our reimbursement efforts paying off as we are getting reimbursement in the first-line indication.

隨著我們在一線適應症中獲得報銷，我們繼續看到我們的報銷努力得到回報。

Japan had sales of $191 million year-to-date, up by 18%.

日本今年迄今的銷售額為 1.91 億美元，增長 18%。

And really, this reflects very focused activities to continue to drive success in the second line, but now we're beginning to commence our launch efforts for the first-line indication and we're seeing success there.

事實上，這反映了非常集中的活動，以繼續推動第二線的成功，但現在我們開始開始我們的一線適應症的啟動工作，我們在那裡看到了成功。

Finally, on Tagrisso in Emerging Markets, we saw $266 million in sales in the year with China contributing the majority.

最後，在新興市場的 Tagrisso，我們看到當年的銷售額為 2.66 億美元，其中中國貢獻了大部分。

We're quite pleased to see Tagrisso added to the National Reimbursement Drug List or NRDL, for second-line T790M-mutated patients, and we do expect to see the NRDL take effect from the new year.

我們很高興看到 Tagrisso 被添加到國家報銷藥物目錄或 NRDL 中，用於二線 T790M 突變患者，我們確實希望看到 NRDL 從新的一年開始生效。

We could potentially see some slower growth on a quarter-over-quarter basis as some patients wait for the implementation of Tagrisso under the NRDL program in the new year, but we certainly see this as a nice opportunity for long-term growth.

由於一些患者在新的一年等待 NRDL 計劃下 Tagrisso 的實施，我們可能會看到季度環比增長放緩，但我們當然認為這是長期增長的好機會。

Please now turn to Slide 16.

現在請轉到幻燈片 16。

Continuing in lung cancer, following the Imfinzi approval in the U.S. for the PACIFIC indication of unresectable Stage III non-small cell lung cancer in the first quarter, we are realizing an inflection point with $371 million in sales for the year and the vast majority of that coming from the U.S. and the lung indication.

繼續在肺癌方面，繼 Imfinzi 在第一季度在美國批准用於不可切除的 III 期非小細胞肺癌的 PACIFIC 適應症之後，我們實現了一個拐點，全年銷售額為 3.71 億美元，絕大多數來自美國和肺部的跡象。

In the U.S., we see roughly half of the PACIFIC-eligible patients in the setting are getting an immunotherapy, the majority of those are getting Imfinzi.

在美國，我們看到大約一半符合 PACIFIC 條件的患者正在接受免疫治療，其中大多數正在接受 Imfinzi。

And we continue to see a positive impact on chemoradiation rates in the U.S. as more patients are becoming eligible for Imfinzi now within this setting.

我們繼續看到對美國化放療率的積極影響，因為現在越來越多的患者在這種情況下有資格接受 Imfinzi。

During the period of the third quarter, Imfinzi was also added to NCCN guidelines as Category 1, further strengthening the standard of care in this setting.

在第三季度期間，Imfinzi 也被添加到 NCCN 指南中作為第 1 類，進一步加強了該環境下的護理標準。

Initial feedback on the launch from physicians and patients is quite good as we continue to drive physician education efforts to address this area of high unmet need in this potentially curative setting.

醫生和患者對啟動的初步反饋非常好，因為我們繼續推動醫生教育工作，以解決這一潛在治療環境中未滿足的高需求領域。

Imfinzi secured approvals in a number of additional countries for the PACIFIC indication, including EU and Japan.

Imfinzi 在其他一些國家獲得了 PACIFIC 適應症的批准，包括歐盟和日本。

Sales outside of the U.S. are gaining momentum as we look to launch and gain reimbursement in the relevant countries.

隨著我們希望在相關國家推出並獲得報銷，美國以外的銷售勢頭正在增強。

And in Japan alone, we delivered $9 million in the quarter following a July approval.

僅在日本，我們在 7 月獲得批准後的那個季度交付了 900 萬美元。

And we're excited to bring Imfinzi to more patients across the globe in this area of unmet need through the rest of the year and 2019.

我們很高興在今年剩餘時間和 2019 年將 Imfinzi 帶給全球更多未滿足需求領域的患者。

For my final slide, please turn to 17.

對於我的最後一張幻燈片，請轉到 17。

Turning now to our emerging hematology franchise, I'd like to reflect the continued progress we are making in hematology, a platform that we're building upon for the years to come.

現在轉向我們新興的血液學專營權，我想反映我們在血液學方面取得的持續進展，這是我們在未來幾年建立的平台。

Calquence continues to perform well with sales of $38 million year-to-date in our fast-to-market, second line relapse refractory mantle cell lymphoma indication.

Calquence 在我們快速上市的二線復發難治性套細胞淋巴瘤適應症中，年初至今的銷售額為 3800 萬美元，繼續表現良好。

We estimate that over 1/3 of patients in the approved indication are now treated with Calquence.

我們估計超過 1/3 的獲批適應症患者現在接受 Calquence 治療。

And we've also seen, importantly, an increase in the use of patients who are BTK/I-naïve patients.

而且我們還看到，重要的是，使用 BTK/I-naïve 患者的患者有所增加。

We look forward to 2 Phase III chronic lymphocytic leukemia data readouts expected in 2019.

我們期待 2019 年預期的 2 項 III 期慢性淋巴細胞白血病數據讀出。

And then also, as Pascal had mentioned, Lumoxiti was recently launched in the U.S. as our first medicine from the antibody drug conjugate platform within the niche, but high unmet need disease of hairy cell leukemia.

然後，正如 Pascal 提到的那樣，Lumoxiti 最近在美國推出，這是我們在利基市場內的抗體藥物偶聯平台的第一個藥物，但毛細胞白血病的高未滿足需求疾病。

We entered into a collaboration with Innate in October where Innate will take on the marketing of Lumoxiti.

我們於 10 月與 Innate 達成合作，Innate 將負責 Lumoxiti 的營銷。

We also gained access to a number of pipeline molecules from Innate.

我們還從 Innate 獲得了一些管道分子。

Lumoxiti takes us now to 5 oncology approvals since the end of 2014, and we are incredibly excited to be one step closer to the 6 new medicines in our Oncology business that we set out to achieve by 2020.

自 2014 年底以來，Lumoxiti 使我們獲得了 5 項腫瘤學批准，我們非常興奮地距離我們計劃到 2020 年實現的腫瘤學業務的 6 種新藥又近了一步。

We continue to appreciate the opportunity to bring what science can do to as many cancer patients as possible.

我們繼續感謝有機會為盡可能多的癌症患者帶來科學的力量。

And with this, I hand it over to Mark.

有了這個，我把它交給馬克。

Thanks, Dave.

謝謝，戴夫。

Now moving to New CVRM, our medicines in cardiovascular, renal and metabolism.

現在轉向新的 CVRM，我們在心血管、腎臟和新陳代謝方面的藥物。

Sales were up 12% despite intense competition with the year-to-date sales at $2.9 billion.

儘管競爭激烈，銷售額仍增長了 12%，年初至今的銷售額為 29 億美元。

Growth for both Farxiga and Brilinta remained strong with double-digit increases globally.

Farxiga 和 Brilinta 的增長依然強勁，在全球範圍內實現了兩位數的增長。

Brilinta delivered sales of $945 million with 18% growth so far in the year-to-date.

Brilinta 今年迄今實現銷售額 9.45 億美元，增長 18%。

And that was driven by strong performance in Emerging Markets, up 31%; and continuous growth in the U.S. and Europe, up 16% and 12%, respectively.

這是由新興市場的強勁表現推動的，增長了 31%；美國和歐洲持續增長，分別增長 16% 和 12%。

So we continue to be very pleased with the performance of Brilinta.

因此，我們繼續對 Brilinta 的表現感到非常滿意。

Farxiga delivered sales of $994 million in the year-to-date with 32% growth, maintaining volume market share leadership globally.

Farxiga 今年迄今實現銷售額 9.94 億美元，增長 32%，保持全球銷量市場份額領先地位。

Farxiga saw a growth of 24% in the U.S. gaining in-class share due to improved competitiveness across health care plans.

由於整個醫療保健計劃的競爭力提高， Farxiga 在美國增長了 24%，獲得了同類份額。

Outside the U.S. where we have 58% of our global sales, we've seen encouraging performances with volume-driven growth increasing with Europe, up 25%; and Emerging Markets, up 57%.

在我們佔全球銷售額 58% 的美國以外，我們看到令人鼓舞的表現，歐洲以銷量為導向的增長增長了 25%；和新興市場，增長 57%。

In China, we are pleased to have delivered reimbursement in 8 provinces so far with further discussions underway.

在中國，我們很高興到目前為止已經在 8 個省份提供了報銷，並正在進行進一步的討論。

We're looking forward to sharing the detailed results of our positive DECLARE study during the American Heart Association in just 2 days' time.

我們期待在短短 2 天的時間內在美國心臟協會期間分享我們積極的 DECLARE 研究的詳細結果。

Turning back to the U.S. in the fast-growing GLP-1 market, our autoinjector Bydureon BCise is a key driver, with the Bydureon franchise continued its growth up 19% growth globally in the quarter.

回到美國快速增長的 GLP-1 市場，我們的自動注射器 Bydureon BCise 是一個關鍵驅動因素，Bydureon 特許經營權在本季度全球範圍內繼續增長 19%。

And importantly, we estimate that over half of our new patients to the franchise are starting on Bydureon BCise.

重要的是，我們估計我們特許經營的新患者中有一半以上是從 Bydureon BCise 開始的。

Next slide, please.

請換下一張幻燈片。

Turning to Respiratory.

轉向呼吸科。

With 5% growth in the quarter, we've now returned to growth in the year-to-date at 2%.

隨著本季度 5% 的增長，我們現在已經恢復到年初至今 2% 的增長。

During the quarter, the ongoing challenge of price competitive environment in the U.S. for Symbicort was offset by solid growth in Japan and Emerging Markets and including the launch of Fasenra.

在本季度，美國價格競爭環境對 Symbicort 的持續挑戰被日本和新興市場的穩健增長所抵消，包括 Fasenra 的推出。

Our Symbicort product sales were down by 9% with a reduction in decline during the quarter of 7%, mainly due to the U.S. pricing pressure slightly moderating this quarter.

我們的 Symbicort 產品銷售額下降了 9%，本季度降幅減少了 7%，這主要是由於本季度美國定價壓力略有緩和。

Volume growth was seen for the second quarter in a row, and global market share leadership was retained.

銷量連續第二個季度增長，全球市場份額保持領先地位。

U.S. Symbicort sales were down 19%, and Europe was down 8%.

美國 Symbicort 銷售額下降 19%，歐洲下降 8%。

However, in Emerging Markets, Symbicort exhibited continued growth, up 12%.

然而，在新興市場，Symbicort 表現出持續增長，增長了 12%。

And growth will be further supported by the updating of guidelines from the Chinese Journal of General Practitioners to incorporate the SYGMA data, recommending that Symbicort or ICS formoterol as an option for all asthma severities.

中國全科醫師雜誌的指南更新將進一步支持增長，以納入 SYGMA 數據，建議將 Symbicort 或 ICS 福莫特羅作為所有哮喘嚴重程度的選擇。

Pulmicort was up 7% with sales of $897 million.

Pulmicort 增長 7%，銷售額為 8.97 億美元。

Emerging Markets was the driver of this growth, up 16%.

新興市場是這一增長的驅動力，增長了 16%。

Please turn to Slide 20.

請轉到幻燈片 20。

As Pascal mentioned, Fasenra continued its strong start with sales of $172 million in the year.

正如 Pascal 提到的那樣，Fasenra 繼續保持強勁的開局，當年銷售額為 1.72 億美元。

The launch continues to perform in line with our expectations given its highly competitive clinical profile.

鑑於其極具競爭力的臨床表現，此次發布繼續符合我們的預期。

In the U.S. and Germany, Fasenra is now the leading novel respiratory biologic in terms of new patient starts.

在美國和德國，就新患者開始而言，Fasenra 現在是領先的新型呼吸生物製劑。

With new patient start leadership in the U.S. now coming from both from allergists and pulmonologists.

隨著新患者的開始，美國的領導層現在來自過敏症專家和肺病專家。

In Japan, Fasenra is the leading biologics both in terms of new patient starts and value regardless of class.

在日本，Fasenra 在新患者開始和價值方面都是領先的生物製劑，無論類別如何。

U.S. sales were $129 million, and Japan delivered a strong early uptake with $26 million.

美國的銷售額為 1.29 億美元，日本的銷售額為 2600 萬美元。

Sales in Europe were $17 million with majority coming from Germany as we continue our launches in other countries.

隨著我們繼續在其他國家推出產品，歐洲的銷售額為 1700 萬美元，其中大部分來自德國。

The strong clinical profile of Fasenra has contributed to its ongoing successes, combined with the significant achievement of our teams at executing against the plan.

Fasenra 強大的臨床形象為其不斷取得成功做出了貢獻，同時我們的團隊在執行該計劃方面取得了重大成就。

This is reinforced by an industry-leading support program to help Fasenra gain appropriate reimbursement in order to provide access to more patients.

行業領先的支持計劃進一步加強了這一點，以幫助 Fasenra 獲得適當的報銷，以便為更多患者提供服務。

In the quarter, we presented data from the BORA trial.

在本季度，我們提供了 BORA 試驗的數據。

BORA is a Phase III extension trial of patients who have completed 1 of the 3 pivotal trials for Fasenra, SIROCCO, CALIMA or ZONDA.

BORA 是一項 III 期擴展試驗，患者已完成 Fasenra、SIROCCO、CALIMA 或 ZONDA 的 3 項關鍵試驗中的一項。

In the BORA trial, Fasenra given for an additional 56 weeks as an add-on treatment showed a safety and tolerability profile similar to that observed in the placebo-controlled registration trials with no increase in the frequencies of overall or serious adverse events.

在 BORA 試驗中，Fasenra 作為附加治療額外給予 56 週，顯示出與安慰劑對照註冊試驗中觀察到的相似的安全性和耐受性特徵，總體或嚴重不良事件的發生頻率沒有增加。

The improvements in efficacy measures observed with Fasenra in the registration trials were maintained over the second year of treatment.

在註冊試驗中觀察到的 Fasenra 療效指標的改善在治療的第二年得以保持。

Within the more than 30 markets that have launched to date, we are now leading the IL-5 class in terms of new patient starts.

在迄今為止推出的 30 多個市場中，我們現在在新患者開始方面處於 IL-5 類的領先地位。

We look forward to other countries coming onboard for the remainder of the year as they initiate their launches.

我們期待其他國家在今年餘下的時間裡開始發射。

Please turn to Slide 21.

請轉到幻燈片 21。

Emerging Markets continue to track in line with long-term performance targets with 12% sales growth in the year-to-date.

新興市場繼續與長期業績目標保持一致，年初至今銷售額增長 12%。

China delivered a strong performance again, as Pascal mentioned, with 27% growth.

正如帕斯卡所說，中國再次表現強勁，增長了 27%。

China benefited from the addition of more medicines to the National Reimbursement Drug List last year and the ongoing launch of Tagrisso, which has already received -- Tagrisso has already received NDLR listing and will come into effect early next year.

中國受益於去年在國家報銷藥品目錄中增加了更多藥品以及 Tagrisso 的持續推出，Tagrisso 已經獲得 NDLR 上市並將於明年初生效。

At the same time, we've now -- had 6 of our main products added to the updated essential drugs list, these are Pulmicort, Symbicort, Iressa, Brilinta, Crestor and Forxiga.

與此同時，我們現在已將 6 種主要產品添加到更新後的基本藥物清單中，它們是 Pulmicort、Symbicort、Iressa、Brilinta、Crestor 和 Forxiga。

Outside of China, we continued to see the impact from divestments, an estimated negative impact of 10%.

在中國以外，我們繼續看到撤資的影響，估計負面影響為 10%。

At the same time, challenging economic conditions continue to negatively impact our business in Russia while in Brazil, we delivered strong double-digit growth.

與此同時，充滿挑戰的經濟狀況繼續對我們在俄羅斯的業務產生負面影響，而在巴西，我們實現了強勁的兩位數增長。

Finally, strong performance continued across our main therapeutic areas in Emerging Markets with Oncology now a $1 billion franchise, up 39%; new CVRM, up 39% as well; and Respiratory, up 15%.

最後，我們在新興市場的主要治療領域繼續保持強勁表現，目前腫瘤學的特許經營權價值 10 億美元，增長 39%；新的 CVRM，也增長了 39%；和呼吸系統，增長 15%。

With this, I'll hand over to Marc.

有了這個，我會交給馬克。

Thank you, Mark, and hello, everyone.

謝謝馬克，大家好。

I'm going to spend the next few minutes taking you through our financial performance in the first 9 months of the year.

接下來的幾分鐘，我將帶您了解我們今年前 9 個月的財務業績。

Please turn to Slide 23.

請轉到幻燈片 23。

As usual, I will begin with the reported profit and loss before turning to the core numbers.

像往常一樣，在轉向核心數據之前，我將從報告的損益開始。

As Pascal mentioned earlier, product sales increased by 2% in the year-to-date, supporting our guidance for the year.

正如 Pascal 之前提到的，今年迄今為止產品銷售額增長了 2%，支持了我們今年的指引。

It is worth remembering that the collaboration with Merck delivered around $1 billion of external revenue by itself in the first 9 months of 2017, which explains that the external revenue declined by 81% in the year-to-date.

值得記住的是，在 2017 年前 9 個月，與默克公司的合作本身就帶來了約 10 億美元的外部收入，這說明今年迄今外部收入下降了 81%。

I do, however, anticipate a significant sum of external revenue and other operating income to be recorded before the end of this year.

不過，我確實預計在今年年底之前將錄得大量外部收入和其他營業收入。

Although external revenue will decline as a proportion of total revenue from what is already a small number, I want to be clear that we remain focused on creating further external opportunities in the future.

儘管外部收入佔總收入的比例將從已經很小的數字下降，但我想明確表示，我們仍然專注於在未來創造更多的外部機會。

As we have begun a long-awaited return to growth, I'm pleased that we have reduced restructuring cost in the year-to-date by $374 million to $271 million.

由於我們已經開始期待已久的恢復增長，我很高興我們今年迄今已將重組成本減少 3.74 億美元至 2.71 億美元。

We have also reduced CapEx by $121 million to $728 million.

我們還將資本支出減少了 1.21 億美元，降至 7.28 億美元。

Anticipated declines in both restructuring cost and capital expenditure over the full year.

預計全年重組成本和資本支出均會下降。

Please turn to Slide 24.

請轉到幻燈片 24。

Moving now to the core profit and loss.

現在轉到核心損益。

Our gross margin ratio for the year-to-date fell as expected by 2 percentage points to 80%, driven by the comparative impact of positive manufacturing variances in the first half of last year as well as the inclusion of the profit share with Merck.

我們年初至今的毛利率如預期下降了 2 個百分點至 80%，這主要是受到去年上半年積極製造差異的比較影響以及與默克公司的利潤分成的影響。

Importantly, the ratio was stable in the third quarter at 79% and very much in line with the second half of 2017.

重要的是，該比率在第三季度穩定在 79%，與 2017 年下半年非常一致。

Total core operating expenses increased by 2%, with a 6% decline in core R&D cost outweighed by 7% increase in core SG&A costs.

核心運營總費用增長了 2%，其中核心研發成本下降了 6%，但核心 SG&A 成本增長了 7%。

Our core tax rate was 19%, within the range of 16% to 20%.

我們的核心稅率為 19%，在 16% 至 20% 的範圍內。

Please turn to Slide 25.

請轉到幻燈片 25。

There was limited externalization revenue in the quarter, with $10 million of upfront income and ongoing external revenue of $64 million.

本季度外部化收入有限，前期收入為 1000 萬美元，持續外部收入為 6400 萬美元。

It is worth highlighting, however, the growing contribution from the collaboration with Merck with $170 million of milestones payments received in the year-to-date.

然而，值得強調的是，與默克公司合作的貢獻不斷增加，今年迄今已收到 1.7 億美元的里程碑付款。

We also see potential for significant revenue in the fourth quarter as option payments, together with $100 million of option payments next year.

我們還看到第四季度作為期權付款的可觀收入潛力，以及明年的 1 億美元期權付款。

We also anticipate a further $150 million milestone receipt before the end of this year.

我們還預計在今年年底前還會收到 1.5 億美元的里程碑式收入。

It is important to note to that there will be a regular stream of milestone payment from Merck over time, which will reduce the viability in externalization revenue.

值得注意的是，隨著時間的推移，默克公司將定期支付里程碑付款，這將降低外部化收入的可行性。

Please turn to Slide 26.

請轉到幻燈片 26。

As I mentioned earlier, core R&D cost declined by 6% in the year-to-date, although I do not anticipate such a decline over the full year at constant exchange rates.

正如我之前提到的，核心研發成本今年迄今下降了 6%，儘管我預計按固定匯率計算全年不會出現這樣的下降。

Despite maintaining a high level of activity, we continue to deliver the benefits of productivity initiative, improved resource utilization, simplification and improved development processes, which are all helping to deliver cost reduction.

儘管保持了高水平的活動，但我們繼續提供生產力倡議、提高資源利用率、簡化和改進開發流程的好處，這些都有助於降低成本。

Reinvestment in our business remain one of our capital allocation priorities and this more targeted investment approach to R&D is delivering consistent results from our pipeline.

對我們業務的再投資仍然是我們的資本分配優先事項之一，這種更有針對性的研發投資方法正在從我們的管道中產生一致的結果。

Core SG&A cost increased by 7% in the year-to-date, reflecting the investment in new medicine launches and in China.

核心 SG&A 成本今年迄今增長了 7%，反映了對新藥上市和中國的投資。

As I said to you in July, we closely monitor our sales performance, and if we see that our investments continue to drive excellent results, we will retain flexibility in our investment approach.

正如我在 7 月份對您所說，我們密切關注我們的銷售業績，如果我們看到我們的投資繼續帶來出色的結果，我們將在投資方法上保持靈活性。

Given the performances from the new medicines and in China, I now anticipate core SG&A cost at constant exchange rate to increase over the full year, broadly in line with those seen in the year-to-date.

鑑於新藥和在中國的表現，我現在預計以固定匯率計算的核心 SG&A 成本將在全年增加，與年初至今的情況基本持平。

Please turn to Slide 27.

請轉到幻燈片 27。

Turning to Brexit.

轉向英國脫歐。

It has mainly operational impact for AstraZeneca.

它主要對阿斯利康產生運營影響。

Our focus, however, is on getting uninterrupted supply of medicine to patients.

然而，我們的重點是為患者提供不間斷的藥物供應。

We are taking a number steps to ensure the continued supply, some of which are shown on the slide.

我們正在採取一些措施來確保持續供應，其中一些措施已在幻燈片中顯示。

The U.K. government has confirmed that it will accept EU-tested medicine in the event of no deal.

英國政府已確認，如果沒有達成協議，它將接受歐盟測試的藥物。

We are working hard to coordinate variation to licenses and thousands of packaging material changes across AstraZeneca.

我們正在努力協調阿斯利康的許可證變更和數千種包裝材料變更。

And as the U.K. pulls away from the EU, we are focusing on the reduction of mutual interdependence as well as replicating critical production processes both in the U.K. and the EU.

隨著英國脫離歐盟，我們正專注於減少相互依賴以及在英國和歐盟複製關鍵生產流程。

To protect long-term supply to EU patients, we are duplicating batch testing of 27 medicines currently performed in the U.K. for EU release in Sweden.

為了保護對歐盟患者的長期供應，我們正在對目前在英國進行的 27 種藥物進行重複批次測試，以便在瑞典發佈歐盟。

To safeguard against friction at borders, we will move stock from the U.K. to European distribution centers to be as close as possible to customers.

為了防止邊境摩擦，我們會將庫存從英國轉移到歐洲配送中心，以盡可能靠近客戶。

We will also build an additional 6 weeks of stock for U.K. supply in line with the government request and 4 weeks extra stock for EU supply.

我們還將根據政府要求為英國供應增加 6 週的庫存，為歐盟供應增加 4 週的庫存。

We're also speaking to the European Union and member state governments around the acceptance of U.K. testing standards.

我們還在就接受英國測試標準與歐盟和成員國政府進行對話。

Operationally, we've been preparing for Brexit since the referendum in 2016.

在運營方面，自 2016 年公投以來，我們一直在為英國脫歐做準備。

I want to reassure to you that over Brexit we'll relatively limited impact on AstraZeneca.

我想向您保證，在英國脫歐之後，我們對阿斯利康的影響相對有限。

We keep preparing carefully for Brexit to ensure that no patients are denied our medicine.

我們一直在為英國退歐精心準備，以確保沒有患者無法獲得我們的藥物。

Please turn to Slide 28.

請轉到幻燈片 28。

And I would like to conclude with our 2018 guidance, which is on product sales and core EPS at constant exchange rates.

我想以我們 2018 年的指導作為結尾，該指導是關於按固定匯率計算的產品銷售和核心每股收益。

The product sales performance in the year-to-date was in line with expectation, so I keep my guidance for low single-digit product sales growth over the full year unchanged.

年初至今的產品銷售業績符合預期，因此我維持全年低個位數產品銷售增長的指引不變。

I continue to anticipate the sum of external revenue and other income will be less than that of 2017.

我繼續預計外部收入和其他收入的總和將低於 2017 年。

We anticipate substantial transaction and potential for Merck income being recorded in the fourth quarter.

我們預計第四季度將錄得默克收入的大量交易和潛力。

We're on track to deliver guidance of a core EPS of $3.30 to $3.50 at constant exchange rates.

我們有望以固定匯率提供 3.30 美元至 3.50 美元的核心每股收益指導。

Finally, our capital allocation priorities remain unchanged given the performance so far this year, the success of our new medicines and the pipeline that is key to our return to growth.

最後，鑑於今年迄今為止的表現、我們新藥的成功以及對我們恢復增長至關重要的管道，我們的資本配置優先事項保持不變。

With that, I will hand over to Sean.

有了這個，我將交給肖恩。

Thank you, Marc.

謝謝你，馬克。

I would now like to take -- to share an overview of our pipeline progress this year and take a look forward at our upcoming news flow.

我現在想分享我們今年管道進展的概述，並展望我們即將到來的新聞流。

Can we please turn to Slide 30.

我們可以轉到幻燈片 30 嗎？

Our level of pipeline news flow continues to be unprecedented.

我們的管道新聞流水平仍然是前所未有的。

There was strong progress with all our new medicines during the year, bringing new benefits to patients across all therapy areas.

在這一年中，我們所有的新藥都取得了長足的進步，為所有治療領域的患者帶來了新的益處。

Within our New Oncology medicines, Lynparza strengthened its lead in ovarian cancer, with positive data in the SOLO-1 trial and received approvals in major markets for breast cancer.

在我們的新腫瘤藥物中，Lynparza 鞏固了其在卵巢癌領域的領先地位，在 SOLO-1 試驗中獲得了積極的數據，並在主要的乳腺癌市場獲得了批准。

We continue to establish our lung cancer franchise with approvals for Tagrisso and Imfinzi across several markets worldwide, building on the unprecedented data from the FLAURA and PACIFIC trials, respectively.

我們繼續建立我們的肺癌專營權，Tagrisso 和 Imfinzi 在全球多個市場獲得批准，分別建立在 FLAURA 和 PACIFIC 試驗的前所未有的數據基礎上。

In CVRM, approvals for Lokelma in the U.S. and EU, kickstarted our growing renal portfolio.

在 CVRM 中，Lokelma 在美國和歐盟獲得批准，啟動了我們不斷增長的腎臟產品組合。

This year, we had positive top line results in Duaklir with our SGLT2 inhibitor, Farxiga.

今年，我們的 SGLT2 抑製劑 Farxiga 在 Duaklir 取得了積極的頂線結果。

And we also submitted Forxiga for type 1 diabetes in the EU and Japan based on novel findings from the DEPICT trials.

我們還根據 DEPICT 試驗的新發現在歐盟和日本提交了用於 1 型糖尿病的 Forxiga。

Also, in Type 2, the Bydureon BCise device is now available to patients in the EU.

此外，在 Type 2 中，Bydureon BCise 設備現在可供歐盟患者使用。

Approvals in asthma for Fasenra and COPD for Bevespi are delivering our respiratory franchise as is FDA breakthrough therapy designation for tezepelumab in the U.S.

Fasenra 的哮喘獲批和 Bevespi 的 COPD 獲批正在提供我們的呼吸專營權，美國食品和藥物管理局對 tezepelumab 的突破性治療指定也是如此。

Please turn now to Slide 31.

請現在轉到幻燈片 31。

With our new oncology medicine, Lynparza is cementing its position as the PARP inhibitor of choice across different tumor types.

憑藉我們的新腫瘤藥物，Lynparza 正在鞏固其作為不同腫瘤類型的首選 PARP 抑製劑的地位。

Today, we can tell you we have submitted the remarkable SOLO-1 data in the EU, Japan and China.

今天，我們可以告訴您，我們已經在歐盟、日本和中國提交了出色的 SOLO-1 數據。

Approvals for first-line maintenance therapy following chemo and BRCA-mutated ovarian cancer, coupled with its already widespread use as a second-line maintenance treatment will establish Lynparza as at leading PARP inhibitor in ovarian cancer.

化療和 BRCA 突變卵巢癌後一線維持治療的批准，加上其作為二線維持治療的廣泛使用，將使 Lynparza 成為卵巢癌中領先的 PARP 抑製劑。

Added to this, next year, we will have data from the Phase III POLO 1 trial which tests Lynparza first-line use in patients receiving bevacizumab maintenance therapy.

除此之外，明年我們將獲得來自 III 期 POLO 1 試驗的數據，該試驗測試 Lynparza 在接受貝伐珠單抗維持治療的患者中的一線使用。

This indication could further broaden the use of Lynparza.

該適應症可進一步擴大 Lynparza 的用途。

Beyond ovarian, we are the leading PARP inhibitor in the treatment of germline BRCA-mutated metastatic breast cancer with approvals secured in the U.S. and Japan and more markets to come.

除了卵巢，我們是治療生殖系 BRCA 突變轉移性乳腺癌的領先 PARP 抑製劑，已獲得美國和日本以及更多市場的批准。

In 2019, we will continue expanding the lifecycle program for Lynparza with data readouts for the POLO trial in pancreatic cancer and the PROFOUND trial for prostate cancer.

2019年，我們將繼續擴大 Lynparza 的生命週期計劃，為胰腺癌的 POLO 試驗和前列腺癌的 PROFOUND 試驗提供數據讀數。

Looking at PARP inhibition in combination with immuno-oncology, we are expanding our testing of Lynparza together with Imfinzi.

結合免疫腫瘤學研究 PARP 抑制，我們正在擴大我們與 Imfinzi 一起對 Lynparza 的測試。

In addition to DuO-O in ovarian cancer, we have a new combination trial, which will explore Lynparza and Imfinzi in non-small cell lung cancer.

除了 DuO-O 在卵巢癌中的應用，我們還有一項新的聯合試驗，將探索 Lynparza 和 Imfinzi 在非小細胞肺癌中的應用。

Please turn to Slide 32.

請轉到幻燈片 32。

Now moving on to Tagrisso, our leading EGFR inhibitor.

現在轉向我們領先的 EGFR 抑製劑 Tagrisso。

Tagrisso is now the standard of care for the treatment of EGFR-mutated, first-line metastatic non-small cell lung cancer, and in the second line for patients with the T790M mutation.

Tagrisso 現在是治療 EGFR 突變的一線轉移性非小細胞肺癌以及 T790M 突變患者的二線治療標準。

The FLAURA data are truly exciting, and have shown that Tagrisso has an unprecedented medium progression-free survival of 18.9 months compared with the 10.2 months for placebo, almost double -- actually for placebo for first-generation EGFR inhibitors.

FLAURA 數據確實令人興奮，並表明 Tagrisso 具有前所未有的中等無進展生存期 18.9 個月，而安慰劑為 10.2 個月，幾乎翻了一番——實際上是第一代 EGFR 抑製劑的安慰劑。

We expect final data on overall survival, the ultimate goal for any cancer, any cancer treatment to be available in the second half of next year.

我們預計在明年下半年可以獲得關於總生存期的最終數據，這是任何癌症的最終目標，任何癌症治療方法。

Looking at the use of Tagrisso an earlier stages of the lung cancer, we anticipate data in the adjuvant setting with the ADAURA trial and in the locally advanced setting with the recently announced LAURA trial to readout beyond 2020.

看看 Tagrisso 在肺癌早期階段的使用，我們預計 ADAURA 試驗的輔助治療數據和最近宣布的 LAURA 試驗的局部晚期治療數據將在 2020 年以後讀出。

Patients in over 80 countries are benefiting from Tagrisso, which has the potential to significantly impact long-term patient outcomes.

80 多個國家/地區的患者正在受益於 Tagrisso，它有可能顯著影響患者的長期預後。

Turn now to Slide 33.

現在轉到幻燈片 33。

Moving on to Imfinzi.

繼續前往 Imfinzi。

At the World Conference on Lung Cancer in Toronto, this September, we showed overall survival data to support use of Imfinzi as the standard of care for Stage III unresectable non-small cell lung cancer following concurrent chemoradiotherapy.

今年 9 月在多倫多舉行的世界肺癌大會上，我們展示了總體生存數據，支持使用 Imfinzi 作為同步放化療後不可切除的 III 期非小細胞肺癌的護理標準。

In the PACIFIC trial, Imfinzi reduced the risk of death by nearly 1/3 on the back of an unprecedented improvement in median PFS of more than 11 months.

在 PACIFIC 試驗中，Imfinzi 將死亡風險降低了近 1/3，這得益於中位 PFS 空前改善超過 11 個月。

Patients in over 40 countries are now benefiting from the PACIFIC regimen.

40 多個國家/地區的患者現在受益於 PACIFIC 方案。

Today, we are announcing a new Stage III trial, PACIFIC-5, to explore Imfinzi following sequential chemoradiation predominantly in Asian patients.

今天，我們宣布一項新的 III 期試驗 PACIFIC-5，主要在亞洲患者中探索序貫化放療後的 Imfinzi。

And also, the new ADRIATIC trial, looking at patients with Stage 3 limited disease small-cell lung cancer, who have not progressed following chemoradiation.

此外，新的 ADRIATIC 試驗研究了 3 期局限性疾病小細胞肺癌患者，這些患者在放化療後沒有進展。

We have a high volume of readouts in the near term looking at Imfinzi, both as a monotherapy and in combination with tremelimumab and/or chemotherapy.

我們在短期內有大量關於 Imfinzi 的讀數，既可以作為單一療法，也可以與 tremelimumab 和/或化療聯合使用。

These trials include MYSTIC in metastatic non-small cell lung cancer and EAGLE in second-line head and neck cancer this year.

今年這些試驗包括轉移性非小細胞肺癌的 MYSTIC 和二線頭頸癌的 EAGLE。

In 2019, data from KESTREL in first-line head and neck cancer will be available as well as late-stage lung cancer readout from NEPTUNE, POSEIDON and CASPIAN.

2019 年，將提供來自 KESTREL 的一線頭頸癌數據以及來自 NEPTUNE、POSEIDON 和 CASPIAN 的晚期肺癌讀數。

In bladder cancer, we now have 7 approvals worldwide for Imfinzi as a second-line treatment, and we expect results next year for its first-line use.

在膀胱癌方面，我們現在在全球範圍內有 7 項批准將 Imfinzi 作為二線治療藥物，我們預計明年將獲得一線使用的結果。

Building on this, the new NIAGARA trial is looking at earlier-stage bladder cancer, specifically muscle-invasive disease.

在此基礎上，新的 NIAGARA 試驗正在研究早期膀胱癌，特別是肌肉浸潤性疾病。

And NILE is testing Imfinzi as a first-line bladder cancer treatment with chemotherapy.

NILE 正在測試 Imfinzi 作為一線膀胱癌化療藥物的療效。

In terms of our next-generation immuno-oncology portfolio, we have recently strengthened our collaboration with Innate Pharma to gain access to some exciting early-stage compounds, including full rights to monalizumab a first-in-class humanized antibody against the NKG2A checkpoint receptor and an option on the anti-CD39 monoclonal antibody.

在我們的下一代免疫腫瘤產品組合方面，我們最近加強了與 Innate Pharma 的合作，以獲得一些令人興奮的早期化合物，包括 monalizumab 的全部權利，這是針對 NKG2A 檢查點受體的一流人源化抗體以及抗 CD39 單克隆抗體的選項。

Please turn now to Slide 34.

請現在轉到幻燈片 34。

With established leadership positions in solid tissue tumors, we have also made encouraging progress with our hematology franchise.

憑藉在實體組織腫瘤領域確立的領導地位，我們在血液學專營權方面也取得了令人鼓舞的進展。

We achieved our first antibody immunotoxin conjugate approval this year with the U.S. approval of Lumoxiti following its Priority Review for third-line use in hairy cell leukemia.

今年，我們獲得了首個抗體免疫毒素偶聯物的批准，美國批准了 Lumoxiti 的三線治療毛細胞白血病的優先審評。

Our BTK inhibitor, Calquence, is expected to be approved outside the U.S. for mantle cell lymphoma in the coming months.

我們的 BTK 抑製劑 Calquence 預計將在未來幾個月內在美國境外獲批用於治療套細胞淋巴瘤。

In chronic lymphocytic leukemia, an indication with a larger population size, our first 2 Phase III trials are due to read out in the second half of 2019.

在人口規模較大的慢性淋巴細胞白血病方面，我們的前兩項 III 期試驗將於 2019 年下半年宣讀。

Turn now to Slide 35.

現在轉到幻燈片 35。

Turning to CVRM, our platform of cardiovascular outcomes trials that are primed to address long-term risk factors for patients with Type 2 diabetes, heart failure, renal disease and dyslipidemia are reading out.

談到 CVRM，我們的心血管結果試驗平台已準備好解決 2 型糖尿病、心力衰竭、腎病和血脂異常患者的長期危險因素。

Positive results from DECLARE, are outcomes trial for Farxiga, will be presented on Saturday at the American Heart Association meeting in Chicago.

DECLARE 的積極結果是 Farxiga 的結果試驗，將於週六在芝加哥舉行的美國心臟協會會議上公佈。

The trial achieved one of its primary endpoints, a statistically significant reduction in the composite endpoint of hospitalization for heart failure or cardiovascular death in a broad population.

該試驗實現了其主要終點之一，即在廣泛人群中因心力衰竭或心血管死亡而住院的複合終點在統計學上顯著減少。

Looking forward to 2019, we expect to have results for Brilinta's outcomes trial THEMIS in patients with coronary artery disease and Type 2 diabetes in the first half of the year.

展望 2019 年，我們預計 Brilinta 在冠狀動脈疾病和 2 型糖尿病患者中的結果試驗 THEMIS 將在今年上半年獲得結果。

In 2020, we will see results from Brilinta's THALES trial in acute ischemic stroke and transient ischemic attack; Epanova STRENGTH trial in mixed dyslipidemia and hypertriglyceridemia, and Farxiga's DAPA-HF trial in heart failure patients with reduced ejection fraction and then data from Dapa-CKD in chronic kidney disease.

2020 年，我們將看到 Brilinta 在急性缺血性中風和短暫性腦缺血發作中的 THALES 試驗結果；混合性血脂異常和高甘油三酯血症的 Epanova STRENGTH 試驗，以及 Farxiga 在射血分數降低的心力衰竭患者中進行的 DAPA-HF 試驗，以及慢性腎髒病中 Dapa-CKD 的數據。

Finally, we have recently announced a new Phase III trial called DELIVER, which looks at the effect of Farxiga in key population, heart failure patients with preserved ejection fracture.

最後，我們最近宣布了一項名為 DELIVER 的新 III 期試驗，該試驗研究了 Farxiga 在關鍵人群、保留射血性骨折的心力衰竭患者中的作用。

The Dapa-HF and DELIVER trials evaluate Farxiga use in both diabetic and nondiabetic patients.

Dapa-HF 和 DELIVER 試驗評估了 Farxiga 在糖尿病和非糖尿病患者中的使用。

Please turn to Slide 36.

請轉到幻燈片 36。

Taking a look now at our growing renal franchise, we received approval for our best-in-class hyperkalemia treatment, Lokelma, in both the United States and EU this year.

現在看看我們不斷增長的腎臟特許經營權，今年我們在美國和歐盟獲得了同類最佳高鉀血症治療 Lokelma 的批准。

At the American Society of Nephrology meeting earlier this month, we announced positive data for our HARMONIZE global trial evaluating the use of Lokelma in patients in Japan, Korea, Taiwan and Russia.

在本月早些時候的美國腎髒病學會會議上，我們公佈了 HARMONIZE 全球試驗的積極數據，該試驗評估了 Lokelma 在日本、韓國、台灣和俄羅斯患者中的使用情況。

The HARMONIZE Asia trial, due to read out in 2019, will support an application in China in 2020.

定於 2019 年宣讀的 HARMONIZE 亞洲試驗將支持 2020 年在中國的申請。

In collaboration with FibroGen, we have an extensive clinical program underway for roxadustat, our first-in-class oral medicine for the treatment of anemia caused by chronic kidney disease and end-stage renal disease.

我們與 FibroGen 合作，針對 roxadustat 開展廣泛的臨床項目，roxadustat 是我們用於治療慢性腎病和終末期腎病引起的貧血的一流口服藥物。

And we expect to receive our first regulatory decision in China by year-end.

我們希望在年底前收到我們在中國的第一個監管決定。

Efficacy data for the phase -- from the Phase III ROCKIES and OLYMPUS trials will be available this year as well data from our partners FibroGen and Astellas.

該階段的療效數據——來自 III 期 ROCKIES 和 OLYMPUS 試驗的數據以及來自我們的合作夥伴 FibroGen 和 Astellas 的數據將於今年提供。

We will file in the U.S. next year based on pooled cardiovascular safety data from the total ALPINE program.

我們明年將根據整個 ALPINE 計劃的心血管安全性匯總數據在美國提交申請。

Turn now to Slide 37.

現在轉到幻燈片 37。

Moving on now to inhaled respiratory medicines.

現在繼續吸入呼吸藥物。

This year, we have made good progress with Bevespi, our fixed-dose dual bronchodilator and the first medicine on the aerosphere platform.

今年，我們在 Bevespi 方面取得了良好進展，這是我們的固定劑量雙聯支氣管擴張劑，也是大氣層平台上的第一個藥物。

Bevespi is now approved in the U.S. and Canada and received a positive CHMP opinion in the EU last month, in addition to regulatory submissions in both Japan and China.

Bevespi 現在在美國和加拿大獲得批准，上個月在歐盟獲得了 CHMP 的積極意見，此外還有日本和中國的監管提交。

PT010, also on the aerosphere platform, is a close triple medication being evaluated initially for the treatment of COPD and eventually asthma.

同樣在大氣層平台上的 PT010 是一種密切的三重藥物，最初被評估用於治療 COPD 和最終的哮喘。

The KRONOS Phase III trial in moderate-to-severe COPD, which was public -- published in Lancet Respiratory Medicine showed a 52% reduction in exacerbation in comparison with dual LAMA/LABA.

公開發表在《柳葉刀呼吸醫學》雜誌上的 KRONOS III 期中度至重度 COPD 試驗顯示，與雙重 LAMA/LABA 相比，急性加重減少了 52%。

KRONOS data has been submitted in Japan and China, and we anticipate submission in the U.S. and EU plus a regulatory decision in Japan to come next year.

KRONOS 數據已在日本和中國提交，我們預計明年將在美國和歐盟提交數據，並在日本做出監管決定。

The next trial read out in the program in the second half of next you will be ETHOS, evaluating the efficacy of PT010 in moderate-to-very severe COPD.

下半場節目中讀出的下一個試驗將是 ETHOS，評估 PT010 在中度至重度 COPD 中的療效。

Please turn now to Slide 38.

請現在轉到幻燈片 38。

And finally, a look at our science-led Biologics portfolio in respiratory disease, starting with Fasenra.

最後，從 Fasenra 開始，看看我們在呼吸系統疾病方面以科學為主導的生物製劑產品組合。

Marc covered the BORA trial earlier, so I will just say we continue to be pleased with Fasenra's profile and long-term safety and efficacy.

Marc 早些時候報導了 BORA 試驗，所以我只想說我們繼續對 Fasenra 的概況以及長期安全性和有效性感到滿意。

Last quarter, we initiated OSTRO, a Phase III trial in nasal polyposis and we expect data readout in 2020.

上個季度，我們啟動了 OSTRO，一項針對鼻息肉病的 III 期試驗，我們預計將在 2020 年公佈數據。

On to tezepelumab.

關於tezepelumab。

Following strong results from the PATHWAY Phase IIb trial in 2017 in which tezepelumab showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma, we hope to see similar results in PATHFINDER, Tezepelumab's Phase III program.

繼 2017 年 PATHWAY IIb 期試驗的強勁結果顯示，與安慰劑相比，tezepelumab 在嚴重、未控制的哮喘患者中顯著降低了年度哮喘發作率，我們希望在 Tezepelumab 的 III 期項目 PATHFINDER 中看到類似的結果。

The first data readout from PATHFINDER is due in 2020.

PATHFINDER 的第一個數據讀出將於 2020 年到期。

Tezepelumab was awarded breakthrough therapy designation status from the U.S. FDA in September 2018, making it the only molecule to be granted BTD for the treatment of asthma, a testament to showing compelling efficacy and safety in Phase IIb for severe asthma patients without an eosinophilic phenotype.

Tezepelumab 於 2018 年 9 月獲得美國 FDA 授予的突破性治療指定地位，使其成為唯一被授予治療哮喘 BTD 的分子，這證明了在沒有嗜酸性粒細胞表型的嚴重哮喘患者的 IIb 期中顯示出令人信服的療效和安全性。

Turn now to Slide 39.

現在轉到幻燈片 39。

To conclude, I would like to remind you of some of the key news flow to come.

最後，我想提醒您一些即將到來的關鍵新聞流。

For Lynparza, we hope to move forward in breast cancer with an approval in the EU and to advance in the first-line BRCA-mutated ovarian cancer with submission of SOLO-1 in the EU, Japan and China with first regulatory decisions expected from the second half of 2019.

對於 Lynparza，我們希望在歐盟獲得批准後在乳腺癌領域取得進展，並在歐盟、日本和中國提交 SOLO-1 後在一線 BRCA 突變卵巢癌領域取得進展，預計歐盟將做出首次監管決定。 2019年下半年。

For Tagrisso, next year, we anticipate a regulatory decision for its first-line use in China where as many as 30% to 40% of non-small cell lung cancer patients have the EGFR mutation, plus the overall survival readout from FLAURA that I referred to earlier.

對於 Tagrisso，我們預計明年將對其在中國的一線使用做出監管決定，在中國，多達 30% 至 40% 的非小細胞肺癌患者俱有 EGFR 突變，加上我從 FLAURA 讀取的總生存期前面提到過。

In Immuno-oncology, we expect a high volume of data readouts across several tumor types for both -- for Imfinzi, both alone and in combination.

在免疫腫瘤學中，我們希望針對 Imfinzi 單獨和聯合使用多種腫瘤類型的大量數據讀數。

We anticipate data for roxadustat plus the first regulatory decision based on efficacy data in China this quarter and submission in the U.S. next year.

我們預計 roxadustat 的數據加上本季度在中國基於療效數據的第一個監管決定，並於明年在美國提交。

For Bevespi in COPD, we hope to receive a decision from the EU and submit in Japan by year-end.

對於 COPD 中的 Bevespi，我們希望收到歐盟的決定並在年底前在日本提交。

With this, thank you, everyone, for your continued support, and thanks to all the hard-working colleagues in AstraZeneca who come to work every day to make this happen.

在此，感謝大家一如既往的支持，感謝阿斯利康所有辛勤工作的同事，他們每天都來上班，讓這一切成為可能。

Now I will hand back to Pascal for closing comments.

現在我將交還給 Pascal 以徵求結束意見。

Thank you, Sean.

謝謝你，肖恩。

Please turn to Slide 41.

請轉到幻燈片 41。

Before we end, let me give you a short summary.

在我們結束之前，讓我給你一個簡短的總結。

We're really pleased by the improving financials and the return to growth in sales in the year-to-date, but most importantly, in quarter 3, more than 9% at CER.

我們對今年迄今財務狀況的改善和銷售恢復增長感到非常高興，但最重要的是，在第三季度，CER 增長超過 9%。

We promised an inflection point, and we delivered it.

我們承諾了一個拐點，我們實現了它。

Total revenue was held back by lower externalization.

較低的外部化阻礙了總收入。

We see potential for significant income in the fourth quarter from Merck.

我們認為默克公司第四季度有可能獲得可觀的收入。

And we also recently announced further streamlining of our portfolio, including Nexium in some markets.

我們最近還宣布進一步精簡我們的產品組合，包括某些市場的 Nexium。

Depending on the structure, such agreements, I either realize as externalization revenue or other operating income.

根據結構，此類協議，我要么實現為外部化收入，要么實現為其他營業收入。

We remain focused on productivity as shown by the 2% increase in total core operating expenses while we continue to invest for growth and in China.

我們仍然專注於提高生產力，核心運營總支出增加了 2%，同時我們繼續投資於增長和中國。

Our ongoing launches and the performance of the new medicines keep us optimistic about the future.

我們不斷推出的新藥和新藥的表現讓我們對未來保持樂觀。

We realized more than $1.8 billion in incremental sales for the new medicines and 76% growth.

我們實現了超過 18 億美元的新藥銷售額增量和 76% 的增長。

China also is doing incredibly well.

中國也做得非常好。

The pipeline has continued to deliver important news flow, which will support sustainable growth moving forward.

該管道繼續提供重要的新聞流，這將支持未來的可持續增長。

So all together, we are clearly on track with our 2018 guidance today.

因此，總而言之，我們今天顯然正在按照 2018 年的指導方針走上正軌。

I will stop here, and we now go to the Q&A.

我會在這裡停下來，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。

(Operator Instructions) Perhaps, we can start with the first question from the conference call, and I will ask Emmanuel Papadakis at Barclays to ask his question.

（操作員說明）也許，我們可以從電話會議的第一個問題開始，我會請巴克萊銀行的 Emmanuel Papadakis 提出他的問題。

Go ahead, Emmanuel.

去吧，伊曼紐爾。

It's Emmanuel Papadakis from Barclays.

我是巴克萊銀行的 Emmanuel Papadakis。

I have lots, but maybe I better start with in order of priority with the cash flow question for Marc.

我有很多，但也許我最好按優先順序從 Marc 的現金流問題開始。

Would just love to hear you reiterate or not your thoughts about still delivering a level of free -- of cash flow from operations, rather, in line or ahead of 2017's $4 billion.

很想听聽您是否重申您的想法，即仍然提供一定程度的自由運營現金流，而不是與 2017 年的 40 億美元持平或領先。

We're obviously a long way from that figure year-to-date, maybe if you could just remind us in terms of the working capital movements as well year-to-date.

從年初至今，我們顯然離這個數字還有很長的路要走，也許你能提醒我們年初至今的營運資金流動情況。

And if I could throw in a relevant addendum.

如果我可以加入相關的附錄。

Your level of comfort on current dividend cover will also be appreciated.

您對當前股息保障的滿意程度也將受到讚賞。

Thank you for these multiple questions on the cash flow.

感謝您提出這些關於現金流的多個問題。

So if you look at the cash flow for -- the cash flow from operations for our year-to-date September, we can see that we are achieving about 400.

因此，如果您查看我們年初至今 9 月份的運營現金流量，我們可以看到我們實現了大約 400。

This is lower than what we had last year at the same time period.

這低於我們去年同期的水平。

This is due, primarily, to lower EBITDA.

這主要是由於較低的 EBITDA。

And of course, the EBITDA of 2017 was supported by a strong external revenue on our contract with Merck.

當然，2017 年的 EBITDA 得到了我們與默克公司合同中強勁外部收入的支持。

So this is one of the reason.

所以這是原因之一。

And on the working capital, if you look at the inventories, receivables and payables, there are not large differences between '17 and '18.

在營運資金方面，如果你看一下存貨、應收賬款和應付賬款，17 年和 18 年之間沒有太大差異。

However, we have had several settlement of litigation that came out from provision, and this has deteriorated the cash outlay for short-term provisions.

然而，我們有幾起因準備金而產生的訴訟和解，這惡化了短期準備金的現金支出。

And then you asked me a question about the dividend.

然後你問了我一個關於股息的問題。

I think the dividend cover, we will have, I mean, definitely, in 2018, our EPS guidance is between $3.30 to $3.50 so that's going to be clearly lower than usual for '20 guidance that we [have thought] in the past.

我認為股息保障，我的意思是，在 2018 年，我們的 EPS 指導肯定在 3.30 美元到 3.50 美元之間，因此這將明顯低於我們過去 [認為] 的 20 年指導。

So it is a fact that 2018 will be a sort of a lower EPS in comparison to previous year.

因此，與上一年相比，2018 年的每股收益將有所下降。

But we will still maintain our dividend policy, which is progressive dividend policy where we maintain or increase whenever we can.

但我們仍將維持我們的股息政策，這是一種漸進式股息政策，我們會盡可能維持或增加。

So I have no special comments on the dividend, which have been reconfirmed time over again by our Board of Directors.

所以我對股息沒有特別的評論，我們的董事會已經再次確認了這一點。

Okay, thank you, Marc.

好的，謝謝你，馬克。

We'll go to next question, Tim Anderson.

我們將轉到下一個問題，蒂姆安德森。

Go ahead, Tim.

來吧，蒂姆。

I have a question on Tagrisso.

我有一個關於 Tagrisso 的問題。

So impressive uptake in Emerging Markets and especially in China, yet in China, it's only approved for second-line use.

新興市場，尤其是中國的吸收率如此之高，但在中國，它只被批准用於二線使用。

You note how the first-line application could be approved in later 2019.

您注意到一線申請如何在 2019 年晚些時候獲得批准。

My question is, how you think that will actually affect uptake relative to today?

我的問題是，您認為這將如何實際影響相對於今天的吸收？

I'm wondering if it's possible that first-line approval could end up actually not having that great of effect as China might push use of first-generation drugs like Tarceva and Iressa in the first-line setting and keep Tagrisso relegated to second line even with the first-line approval.

我想知道一線批准是否有可能最終不會產生那麼大的效果，因為中國可能會在一線環境中推動使用第一代藥物，如特羅凱和易瑞沙，甚至將 Tagrisso 降級為二線獲得一線批准。

So you have NDRL -- or NRDL listing for second line, would you likely get that for first line as well?

所以你有第二線的 NDRL 或 NRDL 列表，你是否也可能獲得第一線的列表？

And then just one quick question on BR31, which is an ADJUVANT trial, is that registrational for Imfinzi?

然後是一個關於 BR31 的快速問題，這是一項 ADJUVANT 試驗，是 Imfinzi 的註冊嗎？

Because it's a cooperative group trial and cooperative group trials are not registrational?

因為是合作組試驗，合作組試驗不是註冊性的？

Thanks, Tim.

謝謝，蒂姆。

Two great questions.

兩個很好的問題。

Maybe, Dave, you can start and then Sean will add.

也許，戴夫，你可以開始，然後肖恩會補充。

Yes, I think, Tim, there's both a potential and the filing question in the Tagrisso piece.

是的，蒂姆，我認為 Tagrisso 的文章中既有潛在問題也有歸檔問題。

Why don't I talk about the market potential component.

為什麼我不談論市場潛力的組成部分。

Sean can speak to the filing.

肖恩可以就文件發言。

And then you can talk about BR31 afterwards.

然後你可以在之後談論 BR31。

So in terms of Tagrisso, maybe just to a start, while your question was front line focused, I think it's worth just taking a moment on second line.

所以就 Tagrisso 而言，也許只是一個開始，雖然你的問題是前線問題，但我認為值得在第二線花點時間。

As you know, we've been launched into the private pay market in China for some time now, and we've seen growth in our sales in China as a result of that.

如您所知，我們進入中國私人支付市場已有一段時間了，因此我們在中國的銷售額有所增長。

And certainly, one of the things that we're encouraged by was the NRDL listing as it opens up the market to quite a bit more patients within second line.

當然，讓我們感到鼓舞的一件事是 NRDL 列表，因為它向更多二線患者開放了市場。

So we estimate that around 115,000 patients will be treated with the first- or second-generation TKI.

因此，我們估計大約有 115,000 名患者將接受第一代或第二代 TKI 治療。

And of those, from a market potential perspective, we think that about 1/4 of them will be tested and found positive for the T790M mutation.

從市場潛力的角度來看，我們認為其中約有 1/4 將接受檢測並發現 T790M 突變呈陽性。

So that gives a sense of the size of the population.

這樣就可以了解人口的規模。

And I think that we certainly count on our operations and commercial teams to be able to drive the uptake that we'll have within NRDL.

而且我認為我們當然指望我們的運營和商業團隊能夠推動我們在 NRDL 中的採用。

In terms of first line, Sean, maybe good point to transition to filing discussions there.

肖恩，就第一線而言，過渡到在那裡提交討論可能是個好點。

Sure.

當然。

Yes, Tim, thanks for the questions.

是的，蒂姆，謝謝你的提問。

With regards to Tagrisso, firstly on China, as you correctly captured, and we expect the regulatory decision from CFDA next year.

關於 Tagrisso，首先是關於中國，正如你正確捕捉到的那樣，我們期待 CFDA 明年做出監管決定。

And I think the question is what will that do to uptake and where does NRDL fit.

我認為問題是這將對吸收產生什麼影響以及 NRDL 適合哪裡。

So the first thing is that all those initial approvals, really, China is a private market at that point.

所以第一件事是所有這些初步批准，真的，中國在那個時候是一個私人市場。

So individuals who are able for that indication to pay for the drug will have access to drug.

因此，能夠為該適應症支付藥物費用的個人將有機會獲得藥物。

So there will be some use that way.

所以那樣會有一些用處。

The other thing I'll point out is, obviously, the duration of use, because the duration of freedom from progression or death is much longer and the first line is actually per patient who initiates quite a bit longer in the first-line therapy.

我要指出的另一件事顯然是使用的持續時間，因為沒有進展或死亡的持續時間要長得多，而且第一線實際上是每個在一線治療中開始相當長一段時間的患者。

The next part is what will happen with NRDL, and I would add there that uncertainty from what the Chinese government will do, but also when they would do it, whatever it might be.

下一部分是 NRDL 會發生什麼，我想補充一點，中國政府將做什麼以及他們何時做的不確定性，無論它是什麼。

So we just -- I think we go step-by-step, first approval, approval will lead to a launch, again to a private market, and then we'll start the discussions with the Chinese government.

所以我們只是 - 我認為我們一步一步地進行，首先批准，批准將導致啟動，再次進入私人市場，然後我們將開始與中國政府的討論。

On to BR31 ADJUVANT trial for Imfinzi and non-small cell lung cancer, you are correct, the trial is sponsored by the Canadian ClinicalTrials Group.

關於 Imfinzi 和非小細胞肺癌的 BR31 ADJUVANT 試驗，你是對的，該試驗由加拿大臨床試驗組贊助。

And the question was is it registrational.

問題是它是否具有註冊性。

Our intention is that it is registrational.

我們的意圖是它是註冊的。

The group has a history of doing trials that have enabled registration in lung cancer.

該小組有進行肺癌登記試驗的歷史。

They were previously called NCI Canada.

他們以前被稱為 NCI 加拿大。

And during that period, were able to conduct trials that support registration.

在此期間，我們能夠進行支持註冊的試驗。

And of course, we work very closely with them during the conduct of the trial to make sure that the quality of the data that results will enable regulatory filing and will meet muster when inspected by regulators globally.

當然，我們在試驗進行期間與他們密切合作，以確保產生的數據質量能夠進行監管備案，並在全球監管機構檢查時滿足要求。

Thank you, Sean.

謝謝你，肖恩。

Next question is from Sachin Jain.

下一個問題來自 Sachin Jain。

Sachin, go ahead.

薩欽，繼續。

Sachin Jain from Bank of America.

美國銀行的 Sachin Jain。

Just at a very high-level financial question.

只是在一個非常高級別的財務問題上。

It's clearly positive to see the sales inflection for the first time as you mentioned perhaps now for a number of years.

正如您現在可能提到的那樣，第一次看到銷售拐點顯然是積極的。

I wonder if you could talk to when we would expect that to flow through to EBIT.

我想知道您是否可以談談我們預計何時會流入息稅前利潤。

And I know it's early and we get formal guidance on '19 next year, but I wondered if you could just talk to some of the moving parts as we think into next year, lower down the P&L, so just color on SG&A growth given the slightly higher guidance for this year, broader comments on the underlying margin leverage and whether do you expect that to offset however one-off income plays through next year.

而且我知道現在還早，我們會在明年的 19 年獲得正式指導，但我想知道你是否可以在我們考慮明年時談談一些移動部件，降低 P&L，所以考慮到 SG&A 增長的顏色今年的指引略有提高，對基本保證金槓桿的更廣泛評論，以及您是否預計這會抵消明年的一次性收入。

Thanks, Sachin.

謝謝，薩欽。

So I think it's a good question.

所以我認為這是一個很好的問題。

I think it's important to remind everybody of what it is we're trying to achieve in this strategy we've got.

我認為重要的是要提醒大家我們在我們現有的戰略中試圖實現的目標。

So first of all, we have to rebuild the pipeline.

所以首先，我們必須重建管道。

So we went into 3 steps.

所以我們進入了 3 個步驟。

One is we rebuild the pipeline because we didn't have any new products.

一是我們重建管道，因為我們沒有任何新產品。

Two is we launched these new products and we turned the pipeline into commercial successes and then top line growth.

二是我們推出了這些新產品，我們將管道轉化為商業成功，然後是收入增長。

So we are in the period right now where we're driving top line growth and we have to drive this as hard as possible.

所以我們現在正處於推動收入增長的時期，我們必須盡可能努力地推動這一點。

And the next phase is to drive the top line growth -- to take the top line growth down to the bottom line.

下一階段是推動頂線增長——將頂線增長降低到底線。

So yes, clearly, we expect the operating margin to improve over the next year or 2. We said that we would expect operating margin to reach industry norm 30% and beyond as we move beyond 2020.

所以，是的，很明顯，我們預計明年或兩年的營業利潤率會有所提高。我們說過，隨著我們超越 2020 年，我們預計營業利潤率將達到行業標準 30% 甚至更高。

And certainly in the meantime, what we're doing is continuing to streamline the portfolio, generate income through this activity then cover the dividend.

當然與此同時，我們正在做的是繼續精簡投資組合，通過這項活動產生收入，然後支付股息。

I just want to repeat them and I want to be clear, with the dividend cover, we will certainly maintain the dividend as we go through this period of time.

我只想重複一遍，我想明確一點，有了股息保障，我們一定會在這段時間裡保持股息。

And we almost at the end of the tunnel, if I may say so, we can see the light at the end of the tunnel.

我們幾乎在隧道的盡頭，如果我可以這樣說，我們可以看到隧道盡頭的光。

The top line growth is strong and if we continue and as we look at 2019, it will continue happening like this.

營收增長強勁，如果我們繼續下去，展望 2019 年，這種情況將繼續發生。

So what we have to do is over the next period of time '19, '20, we'll manage our expenses to drive top line growth.

因此，我們要做的是在接下來的 19 年、20 年期間，我們將管理開支以推動收入增長。

And we're going to focus now our attention to what you might call underlying growth of our EPS of our profit, excluding externalization.

我們現在將把注意力集中在我們利潤每股收益的潛在增長上，不包括外部化。

So we may get some greater visibility and you can be reassured that the business is moving in the right direction.

因此，我們可能會獲得更大的知名度，您可以放心，業務正朝著正確的方向發展。

I can't really be too specific, I'm sorry, just in terms of giving you guidance for the expenses.

抱歉，我真的不能說得太具體，只能為您提供費用方面的指導。

We'll do that early '19.

我們會在 19 年初做到這一點。

But suffice to say, we are very clear that we need to increase the operating margin.

但可以說，我們非常清楚我們需要提高營業利潤率。

To do this, we need to drive top line growth but manage the cost.

為此，我們需要推動收入增長，但要管理成本。

And it's not only SG&A.

不僅是 SG&A。

It's the totality of SG&A and R&D that we have to manage, of course.

當然，這是我們必須管理的 SG&A 和 R&D 的全部。

Can I just have a clarification?

我可以澄清一下嗎？

You mentioned a focus on underlying growth into '19.

你提到了對 19 年潛在增長的關注。

Does that imply guidance models have been on an underlying basis?

這是否意味著指導模型已經建立在基礎之上？

This is the one thing that we are thinking through.

這是我們正在考慮的一件事。

I think certainly being a little bit clearer as to what the underlying growth is, is suddenly going to be very much at the top of our mind.

我認為，對於潛在的增長是什麼，肯定會更清楚一點，這會突然成為我們的首要任務。

But we see what we do with guidance per se, but certainly, we'll make sure that -- I mean, our focus is on that, and we have to see how much details we're going to give on that.

但是我們看到了我們對指導本身做了什麼，但當然，我們會確保——我的意思是，我們的重點是那個，我們必須看看我們要提供多少細節。

But we're thinking it through because it's really key to make sure everybody understands the underlying business is now in a period of very fast growth, and the top line growth is going to drive earnings growth.

但我們正在仔細考慮，因為確保每個人都了解基礎業務現在正處於非常快速增長的時期，而且營收增長將推動盈利增長，這真的很關鍵。

No question about it.

毫無疑問。

So we're going to move to the next question, Peter at Handelsbanken.

那麼我們將轉到下一個問題，Handelsbanken 的 Peter。

Peter Sehested, go ahead, Peter -- sorry, the question is online.

Peter Sehested，繼續，Peter -- 抱歉，在線提問。

Apologies.

道歉。

I'll have to read it.

我將不得不閱讀它。

So the question is being early in the product lifecycle and late in the R&D lifecycle, we're seeing 2018 SG&A cost being higher than initially anticipated and R&D lower.

所以問題是在產品生命週期的早期和研發生命週期的晚期，我們看到 2018 年的 SG&A 成本高於最初預期，而研發成本較低。

But in '19 -- but in '19, 2020, we are still early in the product lifecycle, and you must not be complacent in order not to fall into a 2006 like patent cliff in the future.

但在 19 年——但在 2020 年的 19 年，我們仍處於產品生命週期的早期階段，你不能自滿，以免在未來陷入類似 2006 年的專利懸崖。

Sorry, I'm going through the question here.

抱歉，我在這裡回答這個問題。

This line of thought implies continued strong growth in SG&A in 2019 and maybe slight increase in R&D cost, potentially putting at risk the top line growth to materialize into bottom line, the market is expecting.

市場預期，這種思路意味著 2019 年 SG&A 將繼續強勁增長，研發成本可能會略有增加，這可能會使營收增長面臨風險，從而無法實現盈利。

Please reassure us on your commitment to deliver on consensus expectations.

請向我們保證您將致力於實現共識期望。

Yes, let me just repeat what I said a minute ago.

是的，讓我重複一下我一分鐘前說過的話。

We're very clear that we need to increase operating margin, drive profitability up, take the top line growth to the bottom line, improve our cash flow.

我們非常清楚，我們需要提高營業利潤率，提高盈利能力，將收入增長提高到利潤水平，改善我們的現金流。

There's no doubt.

毫無疑問。

And we said it before, I'll say it again, the plan is to manage for this transition period and then start reducing our debt across 2020.

我們之前說過，我再說一遍，計劃是管理好這個過渡期，然後在 2020 年開始減少我們的債務。

So that is very, very clear.

所以這非常非常清楚。

And that is what we're going to do over the next year and continue to do in 2020.

這就是我們將在明年和 2020 年繼續做的事情。

Jack Scannell at UBS.

瑞銀的傑克·斯坎內爾。

Jack, go ahead.

傑克，繼續。

I've got a long-term question.

我有一個長期的問題。

There's a new challenge that faces people like us now in oncology, and that is that so much as being discovered, that drugs that were pretty good 2 or 3 years ago are being rendered obsolete before their patents expire.

像我們這樣的人現在在腫瘤學領域面臨著一個新的挑戰，那就是發現 2 或 3 年前非常好的藥物在專利到期之前就已經過時了。

So you've done it to Tarceva, Iressa and Gilotrif.

所以你已經對 Tarceva、Iressa 和 Gilotrif 這樣做了。

You're hoping to do it to ibrutinib with Calquence.

您希望通過 Calquence 對 ibrutinib 進行處理。

So if we think about Tagrisso, where there's a patent expiry in 2032 in the orange book, what odds would you give on Tagrisso making it to patent expiry without being rendered technically obsolete as a first-line agent in lung cancer?

因此，如果我們考慮 Tagrisso，在橙皮書中有一項專利將於 2032 年到期，您認為 Tagrisso 使其專利到期而不會作為肺癌一線藥物在技術上過時的可能性有多大？

That's a great question, Jack.

這是一個很好的問題，傑克。

And I think technology, of course, is evolving rapidly these days.

當然，我認為這些天技術正在迅速發展。

But I mean, it's taken us 5 years to get to where we are with Tagrisso.

但我的意思是，我們花了 5 年時間才到達我們與 Tagrisso 的位置。

And I would like to remind everybody, and I'll ask Sean to also comment on this, but I'd like to remind everybody like 5 years ago everybody was saying that there's lots of competitors around you, around Tagrisso that is.

我想提醒大家，我會請肖恩也對此發表評論，但我想提醒大家，就像 5 年前每個人都說你周圍有很多競爭對手，就是圍繞 Tagrisso。

And many of these products have just disappeared.

而且其中許多產品剛剛消失。

So it's not that simple to develop an agent as exquisite as Tagrisso that penetrates the blood/vein barrier as effective as it is.

因此，開發像 Tagrisso 這樣精妙的藥物，能夠像它一樣有效地穿透血液/靜脈屏障，並不是那麼簡單。

Now having said that, we certainly should not be complacent, and we're working ourselves on the next generation of Calquence.

話雖如此，我們當然不應該自滿，我們正在為下一代 Calquence 努力。

And also, more importantly, how do we manage the patients who progress on Tagrisso and develop resistances that escape efficacy from Tagrisso.

而且，更重要的是，我們如何管理在 Tagrisso 上取得進展並產生耐藥性以逃避 Tagrisso 療效的患者。

Now can we say by 2032 Tagrisso will be the only agent out there?

現在我們可以說到 2032 年 Tagrisso 將成為那裡唯一的代理人嗎？

Probably hard to say.

恐怕很難說。

But I think we have quite a few years ahead of us where Tagrisso can still enjoy a pretty nice position.

但我認為我們還有好幾年的時間可以讓 Tagrisso 仍然享有相當不錯的位置。

But, Sean, over to you.

但是，肖恩，交給你了。

Sure, Pascal.

當然，帕斯卡。

Thank you, Jack, for the question.

傑克，謝謝你的提問。

Again, I will reiterate what Pascal said, 2032, that's a ways off, so certainly, a tremendous amount can change between now and then.

再一次，我會重申帕斯卡所說的，2032 年，那是一段很長的路要走，所以當然，從現在到那時會有很大的變化。

At the same time, I think if we were to see an agent that had a really viable opportunity to displace Tagrisso in the normal lifecycle of a drug, say, 5, 6, 7 years in terms of development to launch, we really haven't seen anything that has the attributes that are required.

與此同時，我認為，如果我們看到一種藥物有真正可行的機會在藥物的正常生命週期中取代 Tagrisso，比如說，在開發到上市的 5、6、7 年，我們真的沒有'沒有看到任何具有所需屬性的東西。

Obviously, T790M is something that a lot of companies, including AstraZeneca, have targeted.

顯然，T790M是包括阿斯利康在內的很多公司都瞄準的目標。

As Pascal said, I think it's the central nervous system penetration and ability to really treat a common area of the body where metastases advanced actually are quite lethal and are untreated by other agents probably provides a pretty good period of protection for us.

正如 Pascal 所說，我認為這是中樞神經系統的滲透和真正治療身體公共區域的能力，在這些區域，轉移實際上是非常致命的，並且沒有被其他藥物治療，這可能為我們提供了相當好的保護期。

I'll give another example, Jack, because I think you raise a very important question.

我再舉一個例子，傑克，因為我認為你提出了一個非常重要的問題。

Many of us, quite frankly, a few years ago thought in immunotherapy things would move much faster than they actually have.

坦率地說，我們中的許多人幾年前認為在免疫療法中事情會比實際進展得快得多。

I mean, people saw the number of new targets come up, new combinations.

我的意思是，人們看到了新目標、新組合的出現。

And in fact, we, by now, should have a number of those.

事實上，到現在為止，我們應該擁有其中的一些。

OX40, if you remember, was one of those, and there were many others.

OX40，如果你還記得的話，就是其中之一，還有很多其他的。

And in truth PDX, if I may call it this way, still the mainstay of immunotherapy combination with chemo.

事實上，如果我可以這樣稱呼它，PDX 仍然是免疫療法與化學療法相結合的支柱。

And I do believe new combination of immunotherapies will emerge, but it's probably not as fast as we could have thought a few years back.

我確實相信免疫療法的新組合將會出現，但它可能沒有我們幾年前想像的那麼快。

Jo Walton at Crédit Suisse.

瑞士信貸銀行的喬沃爾頓。

Jo, go ahead.

喬，繼續。

Can I ask about Fasenra, perhaps just on the same theme of new products coming in and making other ones potentially obsolete.

我能問一下 Fasenra 嗎，也許只是關於新產品問世並使其他產品可能過時的相同主題。

But how could you compare Fasenra and Dupixent now that you've seen the Dupixent label?

但是既然你已經看到了 Dupixent 標籤，你怎麼能比較 Fasenra 和 Dupixent 呢？

Thanks, Jo.

謝謝，喬。

I think Mark will be, Mark Mallon will be delighted to talk about Fasenra.

我認為 Mark 和 Mark Mallon 會很高興談論 Fasenra。

Over to you, Mark?

交給你了，馬克？

So I mean, the first response is that we continue to be very confident in Fasenra and our profile, and we think this is a great medicine for treatment of eosinophilic severe asthma.

所以我的意思是，第一反應是我們繼續對 Fasenra 和我們的形象充滿信心，我們認為這是治療嗜酸性重度哮喘的好藥。

We've got a wealth of data through our Phase III studies.

我們通過 III 期研究獲得了大量數據。

We just shared the most recent results of the BORA study, vast improvement in lung function, great reduction in exacerbation, great reduction in OCS use and really favorable dosing approach with once every 2 months or 8 weeks.

我們剛剛分享了 BORA 研究的最新結果，肺功能得到極大改善，惡化大大減少，OCS 使用大大減少，每 2 個月或 8 週一次的真正有利的給藥方法。

And the mechanism of Fasenra with it targeting directly the IL-5, bringing killer cells to the eosinophils, a unique mechanism, is sort of exquisitely designed to target eosinophilic asthma.

Fasenra 的機制是直接靶向 IL-5，將殺傷細胞帶到嗜酸性粒細胞中，這是一種獨特的機制，專門針對嗜酸性粒細胞性哮喘而設計。

And the feedback that we've gotten from physicians is outstanding.

我們從醫生那裡得到的反饋非常出色。

And so if you take that profile and compare it to DUPIXENT, they're going to be patients on which DUPIXENT, based on will be seen on the label will be attractive, for example, overlap patients between atopic dermatitis and severe asthma, obviously, will be a place that we'll go.

因此，如果您採用該概況並將其與 DUPIXENT 進行比較，他們將成為 DUPIXENT 的患者，基於將在標籤上看到的 DUPIXENT 將是有吸引力的，例如，特應性皮炎和嚴重哮喘之間的重疊患者，顯然，將是我們要去的地方。

But it is -- we have to really see how the 2, the IL-4, IL-13 really plays out in a broader audience.

但它是——我們必須真正看到 2、IL-4、IL-13 如何在更廣泛的受眾中真正發揮作用。

We need to understand about how that in some patients we see an increase actually in the eosinophilic levels in response to the medicine.

我們需要了解在某些患者中，我們如何看到嗜酸性粒細胞水平實際增加以響應藥物。

All that has to play out as physicians get a chance to use it.

當醫生有機會使用它時，所有這些都必鬚髮揮作用。

The most important thing I would say is the unmet need is so high in severe asthma.

我要說的最重要的事情是嚴重哮喘的未滿足需求如此之高。

And so with only 1 in 10 severe asthma patients eligible for a biologic getting them, I think would be good to see this market expand.

因此，只有十分之一的嚴重哮喘患者有資格獲得生物製劑，我認為看到這個市場擴大是件好事。

Maybe there'll be some patients that -- certainly, there'll be patients that DUPIXENT is a good option for.

也許會有一些患者——當然，會有一些患者認為 DUPIXENT 是一個不錯的選擇。

But we're confident for our target patients, which are very large, where the unmet need is high and where the evidence is, both from the clinical studies and the physicians and patient experience, is really outstanding.

但我們對我們的目標患者充滿信心，這些患者非常大，未滿足的需求很高，而且來自臨床研究、醫生和患者經驗的證據非常出色。

And so we remain confident.

所以我們仍然充滿信心。

Thanks, Mark.

謝謝，馬克。

I think that's key point actually, Jo, is the growth of the biologics class treating asthma, I mean, is potentially enormous.

我認為這實際上是關鍵點，喬，是治療哮喘的生物製劑類別的增長，我的意思是，它可能是巨大的。

It would have been a bit like comparing 2 new TNF inhibitors 15 or 20 years ago in rheumatoid arthritis, that would have been missing the point that patients needed more biologics treatment, and I think it's the same here.

這有點像 15 或 20 年前在類風濕性關節炎中比較 2 種新的 TNF 抑製劑，這會忽略患者需要更多生物製劑治療的觀點，我認為這在這裡是一樣的。

Of course, there will be competition, and of course, we recognize that DUPIXENT is actually our true competitor.

當然，會有競爭，當然，我們承認 DUPIXENT 實際上是我們真正的競爭對手。

But I think, also, we need to hope that companies collectively will help patients be better treated.

但我認為，我們也需要希望公司共同幫助患者得到更好的治療。

And through this expand class, 10% of patients get a biologic and that should be getting one.

通過這個擴展課程，10% 的患者獲得了生物製品，而且應該得到一個。

What we hear from Fasenra, as Mark told you, is speed of action is important to physicians, full depletion of eosinophils and the efficacy is pretty good for patients with eosinophilic disease.

正如馬克告訴您的那樣，我們從 Fasenra 聽到的是，作用速度對醫生很重要，嗜酸性粒細胞的完全耗盡以及嗜酸性粒細胞疾病患者的療效非常好。

And I would say also because there's a lot of talk around home use, we have a home use program.

而且我還要說，因為有很多關於家庭使用的討論，我們有一個家庭使用計劃。

But what we have from physicians is, in severe asthma, we're not talking about moderate asthma here, we're talking about patients who are severely ill.

但是我們從醫生那裡得到的是，在嚴重哮喘中，我們在這裡談論的不是中度哮喘，而是病情嚴重的患者。

In severe asthma, being able to bring the patient every a couple of months to the office to inject Fasenra is also good from a compliance viewpoint and follow-up.

在嚴重哮喘中，能夠每隔幾個月帶患者到辦公室注射 Fasenra 從依從性和隨訪的角度來看也很好。

So all those, I think, things make Fasenra pretty competitive agent in the marketplace.

因此，我認為，所有這些都使 Fasenra 在市場上成為極具競爭力的代理人。

Luisa Hector at Exane.

Exane 的路易莎·赫克托 (Luisa Hector)。

Luisa, go ahead.

路易莎，繼續。

So switching to diabetes, I just wondered whether you have any comments on your dual GLP-1/GCGR in Phase II?

所以轉向糖尿病，我只是想知道您是否對 II 期的雙 GLP-1/GCGR 有任何評論？

And whether we might see some data soon?

我們是否會很快看到一些數據？

And any thoughts on the outlook given some of the positive data from Lilly recently?

鑑於禮來最近的一些積極數據，對前景有何看法？

And then just checking on Forxiga, the filing time line and how soon you might expect the DECLARE data to impact sales?

然後只需檢查 Forxiga、提交時間表以及您預計 DECLARE 數據多快會影響銷售？

And then maybe just to check on Brexit since you have the slide.

然後也許只是檢查英國退歐，因為你有幻燈片。

It looks like the impact on cost of goods is probably manageable, but are you assuming some of that input -- impact to the stock build in the fourth quarter of this year?

看起來對商品成本的影響可能是可控的，但你是否假設了一些輸入——對今年第四季度庫存增加的影響？

And I assume it's all within your guidance, if that's the case.

如果是這樣的話，我認為這一切都在您的指導範圍內。

Thanks, Luisa.

謝謝，路易莎。

So Sean, do you want to cover the first 2, and Marc Dunoyer might cover the third one.

所以肖恩，你想報導前兩個嗎？馬克·杜諾耶可能會報導第三個。

Okay.

好的。

The first 2, okay, so do Farxiga, DECLARE as well.

前 2 個，好吧，Farxiga 也是如此，DECLARE 也是如此。

Okay, sure.

好的，當然。

So thank you for the questions.

謝謝你的問題。

So starting with the MEDIO382, that's the molecule you're referring to which is the GLP-1/glucagon dual.

所以從 MEDIO382 開始，這就是你所指的 GLP-1/胰高血糖素雙重分子。

So with that molecules, Phase IIb is ongoing, and we are looking at the data.

因此，對於這些分子，IIb 階段正在進行中，我們正在查看數據。

We'll plan to present it when we have it, and really our decision as to where to go next will depend upon our review of that data.

我們將計劃在我們擁有它時展示它，而我們關於下一步去哪裡的決定實際上將取決於我們對該數據的審查。

You mentioned the Lilly molecule.

你提到了 Lilly 分子。

It's slightly different to GLP-1/GIP.

它與 GLP-1/GIP 略有不同。

So we're not -- we'll have to look at the data, look at their data and understand whether the mechanisms might be similar or different in terms of the effects they produce.

所以我們不是——我們必須查看數據，查看他們的數據，並了解這些機制在產生的影響方面是否相似或不同。

The DECLARE question, so we'll present the DECLARE data on Saturday at AHA, and I think you'll get a chance to see what we think is a really extremely meaningful effect both in terms of the reduction in hospitalization heart failure or cardiovascular death, which is the primary endpoint that was met, but also the opportunity to go into a much broader patient population, which is not only Type 2 diabetes patients who have had an index event that would be secondary prevention.

DECLARE 問題，所以我們將在星期六的 AHA 上展示 DECLARE 數據，我想你將有機會看到我們認為在減少住院心力衰竭或心血管死亡方面真正非常有意義的影響，這是達到的主要終點，也是進入更廣泛患者群體的機會，這不僅是發生二級預防指標事件的 2 型糖尿病患者。

But recall, 7,000 such patients in DECLARE.

但請記住，DECLARE 中有 7,000 名此類患者。

There are also 10,000 primary prevention patients.

還有10,000名初級預防患者。

Patients who have not had an index event, so really, a much broader spectrum.

沒有發生過指數事件的患者，範圍更廣。

And we intend to file that data.

我們打算歸檔該數據。

We will do it as soon as we can get the filing together.

我們會盡快完成備案。

And it's probably for Mark to talk about what he expects the impact to be once -- should we get that data on the label and when we do.

Mark 可能會談論一次他預期的影響——我們是否應該在標籤上獲取這些數據以及何時獲取。

So obviously we can't promote until the label has changed, and there's variations of rules around this in different countries around world.

所以很明顯，在標籤改變之前我們不能推廣，而且世界上不同國家/地區對此有不同的規定。

What I think you can say is, as Sean highlighted, there's going to be 2 important things coming out.

我想你可以說的是，正如肖恩強調的那樣，將會出現兩件重要的事情。

One is that this is will be another positive evidence of impact on CV outcomes.

一是這將是影響 CV 結果的另一個積極證據。

In particular, really important complication associated with diabetes is heart failure.

特別是，與糖尿病相關的真正重要的並發症是心力衰竭。

That's going to be really encouraging and supportive result as well as the fact that's going to be a much broader population.

這將是一個非常令人鼓舞和支持的結果，而且事實上這將是一個更廣泛的人群。

So I think it's very exciting news to physicians.

所以我認為這對醫生來說是一個非常令人興奮的消息。

If you look historically, major data like this has an impact on use, even before approval in many cases.

如果你從歷史上看，像這樣的主要數據會對使用產生影響，甚至在許多情況下甚至在批准之前。

So I look to pass bottles to give indication of what could happen here.

所以我希望通過瓶子來指示這裡可能發生的事情。

Thank you, Mark.

謝謝你，馬克。

Regarding the impact of the Brexit on our guidance, I think it's fair to say that will have a minor impact on the level of inventories.

關於英國脫歐對我們指引的影響，我認為可以公平地說，這將對庫存水平產生輕微影響。

But it will also have a minor impact by way of consequence on the EPS, but this is well within our guidance range, and therefore, there's no -- we don't communicate any impact of Brexit on our guidance for 2018.

但它也會對 EPS 產生輕微影響，但這完全在我們的指導範圍內，因此，我們不會傳達英國退歐對我們 2018 年指導的任何影響。

Thanks, Marc.

謝謝，馬克。

So we have a question by email.

所以我們通過電子郵件提出了一個問題。

It's from [Elliott] and it's at [Prem Avenue].

它來自 [Elliott]，位於 [Prem Avenue]。

The question is for you, I think, Dave.

這個問題是給你的，我想，戴夫。

It's regarding Imfinzi and where we are at CRT rate.

這是關於 Imfinzi 以及我們在 CRT 率方面的情況。

Where do you see a ceiling, a plateau from a purely medical perspective?

從純粹的醫學角度來看，你在哪裡看到天花板，高原？

In other words, what proportion of the unresectable Stage III lung cancer population is completely CRT or ineligible and therefore out of reach for Imfinzi?

換句話說，在不可切除的 III 期肺癌人群中，有多少比例完全是 CRT 或不符合 Imfinzi 的條件？

So thanks, Pascal.

所以謝謝，帕斯卡。

So maybe what I can start with is some of the variability that we see right now across regions, which I think gives some sense for how high this could go, and then I'll turn it to Sean to add some color.

因此，也許我可以從我們現在在不同地區看到的一些可變性開始，我認為這可以說明它可能達到多高，然後我會把它交給肖恩來添加一些顏色。

Just if we take within Europe alone, we see CRT rates between, anywhere between 40% in some of the countries where it's lowest, as high as 70% in some of the countries where CRT rates have been adopted.

如果僅在歐洲範圍內，我們就會看到 CRT 率在一些最低的國家/地區介於 40% 之間，在一些已採用 CRT 率的國家/地區高達 70%。

And we believe that there's opportunity to grow CRT rates in all of the regions that we're in.

我們相信，我們所在的所有地區都有機會提高 CRT 率。

I think your question appropriately implies that there are certain patients that just simply will not be seen as being eligible for CRT.

我認為您的問題恰當地暗示了某些患者根本不被視為有資格接受 CRT。

But in terms of the real world right now, that's what we're seeing at the moment and I think suggest that there's an opportunity certainly to get to the overwhelming majority of patients being treated with CRT.

但就目前的現實世界而言，這就是我們目前所看到的，我認為這表明肯定有機會接觸到絕大多數接受 CRT 治療的患者。

Sean?

肖恩？

Yes.

是的。

To add onto that, I think there are 2 opportunities that we're really looking at here.

除此之外，我認為我們真正關注的是兩個機會。

So the majority of patients who have unresectable Stage III get CRT, the vast majority do.

因此，大多數無法切除的 III 期患者都會接受 CRT，絕大多數都會這樣做。

But the one thing is that if there is a tolerability issue, sometimes what will happen both tolerability or access to the coordination that's necessary to get concurrent CRT, which is what PACIFIC studied.

但有一件事是，如果存在容忍度問題，有時會發生什麼情況，無論是容忍度還是獲得併發 CRT 所需的協調，這正是 PACIFIC 研究的內容。

They will sometimes get sequential CRT either for tolerability reasons or due to availability in the geography.

他們有時會出於耐受性原因或由於地理位置的可用性而獲得順序 CRT。

And as I mentioned, PACIFIC 5 is the ongoing study that really studies that too.

正如我所提到的，PACIFIC 5 是一項正在進行的研究，它也真正研究了這一點。

So that's one way to access a different group of patients.

所以這是接觸不同患者群體的一種方式。

We're also hearing, and I don't think this is something we can really quantitate, but we're hearing physician start to think differently around how aggressive they want to be with surgical resection of Stage III non-small cell lung cancer, given the data that's being seen with PACIFIC and whether they may choose to have the patient undergo a CRT rather than attempt a large or complex surgical resection.

我們也聽到了，我不認為這是我們可以真正量化的東西，但我們聽到醫生開始對他們希望手術切除 III 期非小細胞肺癌的積極程度有不同的看法，考慮到 PACIFIC 的數據，以及他們是否可以選擇讓患者接受 CRT 而不是嘗試進行大型或複雜的手術切除。

Thanks, Sean.

謝謝，肖恩。

So we have a question from Alex at BMO Capital Market.

BMO Capital Market 的 Alex 提出了一個問題。

Alex, go ahead.

亞歷克斯，繼續。

Pascal, you mentioned there was skepticism about AstraZeneca's ability to return to growth and I want to build on that, please.

帕斯卡，你提到有人對阿斯利康恢復增長的能力持懷疑態度，我想在此基礎上再接再厲。

As we enter the growth phase, I was wondering if you could revisit your 2023 guidance of $45 billion.

當我們進入增長階段時，我想知道您是否可以重新審視 2023 年 450 億美元的指導方針。

I think that's about $40 billion to $40 billion -- excuse me, $40 billion to $41 billion that's actually adjusted now?

我認為這大約是 400 億到 400 億美元——對不起，現在實際調整後的 400 億到 410 億美元？

And recent management commentary suggest that, that it was still possible.

最近的管理層評論表明，這仍然是可能的。

Obviously, a lot has changed since you provided that guidance, and it is significantly higher than what you'd expect?

顯然，自從您提供該指導以來，發生了很多變化，並且它明顯高於您的預期？

So I'm just wondering do you still believe that you can get to $40 billion by 2023?

所以我想知道您是否仍然相信到 2023 年可以達到 400 億美元？

And if so, what are the ways that you can get there that are not well understood by the investment community?

如果是這樣，投資界不太了解的方法有哪些？

Yes, it's a great question.

是的，這是一個很好的問題。

The plan, as we have developed it today, still takes us to that kind of level.

正如我們今天制定的那樣，該計劃仍然使我們達到了那種水平。

And I see no reason at this point to change this, Alex.

我認為目前沒有理由改變這一點，亞歷克斯。

And to answer whether we will get there or not is hard because, to some extent, it depends on how we execute commercially.

很難回答我們是否會到達那裡，因為在某種程度上，這取決於我們如何進行商業執行。

But this, we have what it takes to deliver.

但是，我們擁有交付所需的一切。

And then the other part is the success of our products and new indications in the pipeline.

然後另一部分是我們產品的成功和管道中的新適應症。

So that will happen over -- I mean, will become clear over time.

所以這將會發生——我的意思是，隨著時間的推移會變得清晰。

roxadustat, for instance, we'll know pretty soon.

例如，roxadustat，我們很快就會知道。

Next year we'll have more data.

明年我們會有更多數據。

We'll have, for instance, the POSEIDON study in immuno-oncology.

例如，我們將進行免疫腫瘤學中的 POSEIDON 研究。

We have ADJUVANT studies.

我們有輔助研究。

We have -- with both Tagrisso, sorry, and Imfinzi, we have first-line ovarian cancer study in combination with Avastin for Lynparza.

我們有——對不起，Tagrisso 和 Imfinzi，我們有一線卵巢癌研究與 Avastin 聯合用於 Lynparza。

We have tezepelumab that is in progressing through the pipeline.

我們有正在通過管道進行的 tezepelumab。

We have -- if strengths, we've not talked about Epanova much, but its strengths is positive and we'll see this weekend the Amarin results, I mean that Epanova has substantial potential, so there's a whole range of products that are still potentially underestimated because we don't know whether they're going to work or not.

我們有——如果有優勢的話，我們沒有過多地談論 Epanova，但它的優勢是積極的，我們將在本週末看到 Amarin 的結果，我的意思是 Epanova 具有巨大的潛力，所以有一整套產品仍然是可能被低估了，因為我們不知道它們是否會起作用。

But when we do our risk-adjusted sales forecast, we still are on track to get there.

但當我們進行風險調整後的銷售預測時，我們仍然有望實現目標。

And it turns into, of course, I'm not disclosing anything that you cannot work out yourself, it turns into a compound growth rate of about 12%, 13% a year between now and then.

它變成了，當然，我不會透露任何你無法自己解決的事情，它變成了大約 12% 的複合增長率，從現在到那時每年 13%。

So the question is can we achieve it?

那麼問題是我們能做到嗎？

And the answer is we still believe we can do it, but it depends on the pipeline and how it unfolds.

答案是我們仍然相信我們可以做到，但這取決於管道及其展開方式。

So more to come over the next year or 1.5 years in terms of the clinical news, really.

就臨床新聞而言，明年或 1.5 年內會出現更多，真的。

Going back to Farxiga, for instance, that we're talking a minute ago.

回到 Farxiga，例如，我們一分鐘前正在談論。

I think people sometimes maybe underestimate the potential of heart failure.

我認為人們有時可能低估了心力衰竭的可能性。

I think we all have to understand heart failure is as costly as cancer in terms of health care cost.

我想我們都必須明白，就醫療保健成本而言，心力衰竭與癌症一樣昂貴。

It's a major problem.

這是個大問題。

So if we in diabetes can establish that the SGLT2 agents actually reduce the incidence of heart failure and also have a potential positive effect on the kidney, which we believe is the case, then the potential for the SGLT2 class is enormous.

因此，如果我們在糖尿病患者中能夠確定 SGLT2 藥物確實可以降低心力衰竭的發生率並且對腎臟也有潛在的積極影響（我們相信是這種情況），那麼 SGLT2 類藥物的潛力是巨大的。

And of course, it's a competitive class, but still, we believe we have a good chance to succeed here.

當然，這是一個有競爭力的課程，但我們仍然相信我們有很好的機會在這裡取得成功。

So that's really a lot of opportunities for us to grow.

所以這真的是我們成長的很多機會。

Let's move to Seamus at Guggenheim.

讓我們轉到古根海姆的 Seamus。

Seamus?

西默斯？

So I just had one question.

所以我只有一個問題。

Can you talk a little bit about the safety profile as presented on roxadustat at the ASN?

您能談談 ASN 上關於羅沙司他的安全概況嗎？

My understanding is again we saw a little bit of some safety dynamics there that brought forward some concern.

我的理解是，我們再次看到了一些安全動態，這引起了一些擔憂。

But I'd love to just hear how AstraZeneca is thinking about those data sets, and then when we're likely to see the more complete data set for cardiovascular events differential between EPO.

但我很想听聽阿斯利康（AstraZeneca）是如何考慮這些數據集的，然後我們什麼時候可能會看到 EPO 之間心血管事件差異的更完整數據集。

And then just to expand on that, could you guys talk about the opportunity in predialysis and the ability to gain reimbursement should you show an ability to kind of expand back into that market?

然後只是為了擴展這一點，你們能否談談透析前的機會以及獲得報銷的能力，如果你們表現出某種擴展回那個市場的能力？

Thanks, Seamus, so one question for Sean and a question for Marc.

謝謝 Seamus，一個問題給 Sean，一個問題給 Marc。

Thomas, kindly remind us to be short and sharp, so we can manage all the questions left, so over to you, Sean.

托馬斯，請提醒我們要簡短明了，這樣我們就可以解決所有剩下的問題，所以就交給你了，肖恩。

Okay, I will try and give you a short and sharp answer to a very complicated question, Seamus.

好吧，Seamus，我會盡量給你一個非常複雜的問題的簡短而尖銳的答案。

I think there was some data at ASN.

我認為 ASN 上有一些數據。

That's primarily efficacy data from Asia, it's small hundreds of patients actual events.

這主要是來自亞洲的療效數據，它是數百名患者的實際事件。

We're talking a handful with a small difference.

我們說的是少數，差別很小。

And my argument from the safety standpoint with unusual events you can't really conclude anything from that data.

從安全的角度來看，我對異常事件的論點是你無法從這些數據中真正得出任何結論。

This is, of course, a complex patient population that has risk factors for cardiovascular events because they have chronic kidney disease, they often have an underlying comorbidity that cause that and they're on dialysis.

當然，這是一個複雜的患者群體，他們具有心血管事件的危險因素，因為他們患有慢性腎臟疾病，他們通常有導致心血管疾病的潛在合併症，並且他們正在接受透析。

So with regard to -- then the rest of the question is, so what will we know.

所以關於 - 那麼剩下的問題就是，我們會知道什麼。

I think the way that this will work is by the end of this year, as we have said, you will have efficacy data from our ongoing program.

我認為這將在今年年底之前發揮作用，正如我們所說，您將從我們正在進行的計劃中獲得療效數據。

The largest trials there are ROCKIES and OLYMPUS.

那裡最大的試驗是ROCKIES和OLYMPUS。

OLYMPUS being in the predialysis patient population, so nondialysis dependent; ROCKIES being in the dialysis dependent.

OLYMPUS 屬於透析前患者群體，因此不依賴透析； ROCKIES 處於透析依賴狀態。

And OLYMPUS with almost 2,800 patients.

奧林巴斯擁有近 2,800 名患者。

ROCKIES with a bit over 2,000, 2,100, so much larger datasets.

ROCKIES 擁有超過 2,000、2,100 個更大的數據集。

So the efficacy data is based on hemoglobin response.

所以療效數據是基於血紅蛋白反應。

What we have also guided to everyone is that the basis for filing will be an aggregated safety profile across the whole program.

我們還向所有人提供的指導是，歸檔的基礎將是整個計劃的綜合安全概況。

And because we have to aggregate multiple trials, multiple sponsors in order to do that, it will be sometime next year, first half of next year that we will be able to share that aggregated safety profile.

因為我們必須匯總多項試驗，多個贊助商才能做到這一點，明年某個時候，明年上半年，我們將能夠分享匯總的安全概況。

And again, we'll have 2 versions of it.

同樣，我們將有 2 個版本。

One is that which will occur from more than 3,000 or 3,500 patients who are dialysis dependent and then an even larger number who are nondialysis dependent: dialysis dependent versus ESAs, nondialysis dependent versus placebo.

一種是將發生在超過 3,000 或 3,500 名透析依賴患者中，然後是更多非透析依賴患者：透析依賴與 ESAs，非透析依賴與安慰劑。

And I will let Mark talk about opportunity.

我會讓馬克談談機會。

Short answer for predialysis is we see substantial opportunity and a compelling case, we think, for payers.

對於透析前的簡短回答是，我們認為對於付款人來說，我們看到了大量的機會和令人信服的案例。

We'll need to do a lot of education, of course, because this is something new.

當然，我們需要做很多教育，因為這是新事物。

But anemia is clearly an issue.

但貧血顯然是一個問題。

And people living with it, it is a problem.

和它一起生活的人，這是一個問題。

And CKD patients already have a lot of problems.

而 CKD 患者已經有很多問題。

And so having a chance to address this one will be I think really important, so we're very excited for the opportunity.

因此，我認為有機會解決這個問題非常重要，因此我們對這個機會感到非常興奮。

Yes, large, large opportunity for sure.

是的，肯定有很大很大的機會。

Andrew Baum, Andrew at Citi, go ahead.

安德魯鮑姆，花旗的安德魯，繼續。

Couple of questions.

幾個問題。

I imagine that duration -- median duration of Tagrisso treatment has increased.

我想 Tagrisso 治療的持續時間——中位持續時間已經增加。

Hello, we are losing you a little bit.

你好，我們有點失去你了。

Yes, go ahead.

好，去吧。

We were losing you.

我們正在失去你。

The line was interrupted.

線路中斷了。

I imagine the duration treatment has increased following first-line approval.

我想在一線批准後治療持續時間會增加。

This is a bit of a loaded question.

這是一個有點沉重的問題。

But where do you think this could go given the use of combination therapies addressing c-Met, as well as other targets in order to overcome T790M beyond progression using Tagrisso beyond progression?

但是，考慮到使用針對 c-Met 的聯合療法以及其他目標以使用 Tagrisso beyond progression 克服 T790M 超越進展，您認為這會走向何方？

And then second, could you comment on your level of conviction in the differentiated safety profile of Calquence over IMBRUVICA given some recent publications suggesting that the bleeding seen as a BTK-related phenomenon rather than off-target?

其次，鑑於最近的一些出版物表明出血被視為 BTK 相關現象而不是脫靶現象，您能否評論一下您對 Calquence 與 IMBRUVICA 的差異化安全概況的信念程度？

Thanks, Andrew.

謝謝，安德魯。

Sean, both questions for you, I guess.

肖恩，我想這兩個問題都問你。

The first one is Tagrisso and how far can it go.

第一個是Tagrisso，它能走多遠。

Yes, I think there were -- there was almost a commercial element in it for day I thought.

是的，我認為有——我想那一天幾乎有商業元素。

But obviously, we've seen -- we see from FLAURA that we get considerable extension of the progression-free survival.

但顯然，我們已經看到——我們從 FLAURA 中看到，我們的無進展生存期得到了相當大的延長。

And we believe that as first line becomes a standard of care, that will lead to each given patient's duration of treatment on Tagrisso being much longer just because they're benefiting for considerably longer.

我們相信，隨著一線治療成為一種標準治療，這將導致每個給定患者在 Tagrisso 上的治療持續時間更長，因為他們受益的時間要長得多。

I think the thing that will really drive that home as we anticipate in the second half of next year is if the survival data also shows that benefit manifest in that endpoint.

我認為，真正推動我們在明年下半年實現這一目標的是，如果生存數據也顯示出該終點的好處。

You ask about MET inhibitors, acalabrutinib is probably is where you're going with that.

你問的是 MET 抑製劑，acalabrutinib 可能就是你要去的地方。

That is an ongoing testing.

那是一個持續的測試。

Interestingly, at ESMO, we're seeing some variation in the percentage of patients that may be using met overexpression, or their tumor, I should say rather using that overexpression to overcome treatment like Tagrisso.

有趣的是，在 ESMO，我們看到可能使用 met 過表達或他們的腫瘤的患者百分比有所不同，我應該說使用過表達來克服像 Tagrisso 這樣的治療。

And so that's something we're evaluating in the clinical, and then also Dave and his team are evaluating the opportunity.

所以這是我們在臨床上評估的東西，然後戴夫和他的團隊也在評估這個機會。

Calquence and bleeding, we believe that the ability to differentiate Calquence based on safety is due to the incidence of severe bleeding episodes and also other severe side effects like atrial fibrillation.

Calquence 和出血，我們認為基於安全性區分 Calquence 的能力是由於嚴重出血事件的發生率以及心房顫動等其他嚴重副作用。

We are accumulating obviously a lot of safety experience with the molecule.

顯然，我們正在積累大量關於該分子的安全經驗。

And we believe it has reinforced the opportunity that we saw when we initially did the deal with Acerta to acquire the molecule.

我們相信它加強了我們最初與 Acerta 達成交易以獲取該分子時看到的機會。

And ultimately, the mechanism of action of something like bleeding and severe bleeding is multifactorial.

最終，出血和嚴重出血等事件的作用機制是多因素的。

There may be a BTK inhibition component, but it's probably likely that there are other things as well.

可能有 BTK 抑製成分，但也可能還有其他成分。

So we remain as confident as we were that we can differentiate based on safety.

因此，我們仍然像過去一樣自信，我們可以根據安全性進行區分。

I think the question from CL-006 when we go head-to-head with abrutinib and generate gold standard data is do we also have an opportunity to differentiate on efficacy.

我認為，當我們與 abrutinib 正面交鋒並生成黃金標準數據時，CL-006 提出的問題是，我們是否也有機會區分療效。

I think one small data point just, Andrew, to add on this, while the frontline, it's still early days to know whether or not we're getting to the durations that we saw within the FLAURA study.

我認為只有一個小數據點，安德魯，補充這一點，雖然在前線，但現在要知道我們是否達到了我們在 FLAURA 研究中看到的持續時間還為時過早。

In the second line, we saw patients being treated to progression.

在第二線，我們看到患者正在接受治療以取得進展。

And it is testimony also to the tolerability profile of Tagrisso, which I think is an important aspect of our patients getting to what we see in the studies.

這也證明了 Tagrisso 的耐受性，我認為這是我們的患者獲得我們在研究中看到的結果的一個重要方面。

Thanks, Dave.

謝謝，戴夫。

So we have a question from Steve Scala at Cowen online, which is about the SG&A guidance.

所以我們有一個來自 Cowen 在線的 Steve Scala 的問題，這是關於 SG&A 指南的。

Marc mentioned that G&A, first of all, it's at CER, what you see on the P&L, and then it's 7%.

Marc 提到 G&A，首先是 CER，你在 P&L 上看到的，然後是 7%。

And I think Marc said the guidance for the year was that SG&A would go at the rate we see at the end of 9 months, so the same similar rate.

我認為馬克說今年的指導是 SG&A 將按照我們在 9 個月末看到的速度進行，所以相同的速度。

I would encourage you though to look at the totality of operating cost, R&D and SG&A, which at the end of September, as Marc mentioned are growing 2% total.

不過，我鼓勵您查看運營成本、研發和 SG&A 的總和，正如 Marc 提到的那樣，截至 9 月底，總計增長了 2%。

Marc, anything you would like to add to this?

馬克，你想補充什麼嗎？

It's 7% for the quarter 3 -- 7%, sorry, for SG&A, sorry.

第 3 季度是 7%——對不起，SG&A 是 7%，對不起。

At CER, 7% for quarter 3, 7% for year-to-date and estimated to be 7% for the end of the year.

根據 CER，第三季度為 7%，年初至今為 7%，預計年底為 7%。

Or I said broadly in line, but around 7% would be conclusion.

或者我說大致符合，但結論是大約 7%。

This is CER?

這是 CER？

Yes, everything's at CER.

是的，一切都在 CER。

James Gordon at JPMorgan.

摩根大通的詹姆斯戈登。

James, go ahead and maybe we will take this as the last question.

詹姆斯，繼續，也許我們會把這個作為最後一個問題。

Thomas, is it okay?

托馬斯，還好嗎？

James, go ahead.

詹姆斯，繼續。

This is Sarita Kapila from JPMorgan.

我是摩根大通的 Sarita Kapila。

Could you please comment on your appetite for equity funded M&A?

您能否評論一下您對股權融資併購的興趣？

And if a significant deal was to be pursued in the future, where would the focus likely be?

如果未來要達成一項重大協議，重點可能在哪裡？

Would it be on accretion or growth or pipeline optionality?

它是關於增生、增長還是管道可選性？

Thanks for the question.

謝謝你的問題。

I mean, if we were to do anything, it would be for accretion for sure because that's really -- there's no other way we could do anything else.

我的意思是，如果我們要做任何事情，那肯定是為了吸積，因為那真的——我們沒有其他方法可以做任何其他事情。

But I have to say our focus is not on this.

但我不得不說，我們的重點不在此。

Our focus is really on launching this product and turning this pipeline into a reality.

我們的重點實際上是推出該產品並將該管道變為現實。

We still have a lot of work to do growing our top line and a lot of work to do driving increase in operating margin.

我們還有很多工作要做，以增加我們的收入，並做很多工作來推動營業利潤率的增長。

We're very committed to doing this.

我們非常致力於這樣做。

Right now, we are in this transition period.

現在，我們正處於這個過渡時期。

And I would say, almost toward the end of the transition period, where we have to invest to really launch all those products.

我會說，幾乎在過渡期即將結束時，我們必須投資才能真正推出所有這些產品。

But it's very clear to us we need to drive operating margin up, and that's what we're going to be doing over the next couple of years.

但我們很清楚，我們需要提高營業利潤率，這就是我們未來幾年要做的事情。

So that's really our focus.

所以這真的是我們的重點。

And any acquisition or M&A would have to be accretive, if that's -- but again, this is really not our focus.

如果是這樣的話，任何收購或併購都必須是增值的——但同樣，這真的不是我們的重點。

So, Thomas told me we can take one more actually, so we'll take the last question from Richard, Richard Parkes at Deutsche Bank.

所以，Thomas 告訴我我們實際上可以再回答一個問題，所以我們將接受來自德意志銀行的 Richard，Richard Parkes 的最後一個問題。

Richard, go ahead.

理查德，繼續。

I'm just going to ask one clarification and one follow-up question.

我只想問一個澄清和一個後續問題。

The clarification is on the roxadustat safety question.

澄清是關於 roxadustat 安全問題。

I think one of the concerns with hyperkalaemia imbalance that we've seen in those studies that were presented.

我認為我們在所提出的那些研究中看到的對高鉀血症失衡的擔憂之一。

So I just want to clarify, when you looked at the integrated safety database of all the Phase II trials, was there any signal of increased hyperkalaemia risk?

所以我只想澄清一下，當你查看所有 II 期試驗的綜合安全數據庫時，是否有任何高鉀血症風險增加的信號？

Because I know one of the Phase II studies there was an imbalance there.

因為我知道其中一項 II 期研究存在不平衡。

So I just wondered if you could clarify that?

所以我只是想知道你是否可以澄清一下？

And then on Calquence, you talked about 1/3 of new patients going on Calquence in the current indication.

然後在 Calquence 上，你談到了 1/3 的新患者在當前適應症中接受 Calquence。

I wondered what anecdotal feedback you were getting from physicians over the drug's profile compared to your competitor, and maybe how the tolerability is playing out in the real world.

我想知道與您的競爭對手相比，您從醫生那裡得到了哪些關於藥物概況的軼事反饋，以及耐受性在現實世界中的表現如何。

What is it driving patients to choose Calquence versus the competition?

是什麼促使患者選擇 Calquence 而不是競爭產品？

Great questions.

很好的問題。

Maybe we can start with the last one.

也許我們可以從最後一個開始。

David, do you want to cover Calquence?

大衛，你想報導 Calquence 嗎？

And then, Sean, you will cover the roxadustat safety question.

然後，肖恩，你將討論 roxadustat 安全問題。

So thanks, Richard, for the question.

謝謝理查德提出的問題。

I think, as you know, about 1/3 of share of the BTI class is now Calquence's.

我認為，如您所知，BTI 類中大約 1/3 的份額現在是 Calquence 的。

I think that, really, a very important additional element that we're seeing and this will get to the qualitative aspect is that we're seeing increased utilization in the BTKI-naïve patients in the second line.

我認為，真的，我們看到的一個非常重要的附加因素，這將涉及定性方面，即我們看到二線 BTKI 初治患者的利用率增加。

So a lot of the initial trial post launch a year ago was happening in third plus line patients after patients have been exposed to a BTKI.

因此，一年前啟動後的許多初始試驗都是在患者接觸 BTKI 後在三線以上患者中進行的。

Because of the positive trial experience that physicians have had with the agent in those settings, we're seeing more and more utilization moving into earlier lines of therapy.

由於醫生在這些環境中使用該藥物的積極試驗經驗，我們看到越來越多的藥物被用於早期治療。

And what that means is that it's becoming the preferred choice within the indication among the BTKI inhibitors, and we see that as very encouraging.

這意味著它正在成為 BTKI 抑製劑適應症的首選，我們認為這非常令人鼓舞。

Thanks, David.

謝謝，大衛。

Okay, Richard.

好的，理查德。

So the question sort of had 2 elements, one is now moving to hyperkalaemia, I believe Andrew's question was actually about bleeding with roxadustat?

所以這個問題有兩個要素，一個現在轉向高鉀血症，我相信安德魯的問題實際上是關於羅沙司他的出血？

Yes, roxadustat.

是的，羅沙司他。

I'm sorry, yes, so roxa safety, that question is about CV risk.

對不起，是的，所以 roxa 安全，這個問題是關於 CV 風險的。

Again, this is a small dataset.

同樣，這是一個小數據集。

It's very difficult to interpret adverse events that are actually known consequences of the underlying condition that you're treating.

很難解釋不良事件，這些不良事件實際上是您正在治療的潛在疾病的已知後果。

So these are dialysis -- this is a small data set on dialysis-dependent chronic kidney disease patients.

所以這些都是透析——這是一個關於依賴透析的慢性腎病患者的小數據集。

These patients' kidneys aren't able to regulate their potassium levels.

這些患者的腎臟無法調節他們的鉀水平。

So in a small data set, you can easily get an asymmetry in these kinds of events that are known to be related to the disease and actually how the dialysis can be given varies, so that can change its incidence as well.

所以在一個小數據集中，你可以很容易地得到這些已知與疾病相關的事件的不對稱性，實際上透析的方式也各不相同，這樣也可以改變它的發生率。

Again, based on the data we have, we haven't seen anything to suggest that the safety profile is adverse for roxadustat.

同樣，根據我們擁有的數據，我們沒有看到任何跡象表明安全狀況對 roxadustat 不利。

The limitation there is that it is small.

那裡的限制是它很小。

And so the definitive data set will come from the pooling, and we will look at all adverse events over that pooled data set.

因此，最終數據集將來自合併，我們將查看該合併數據集的所有不良事件。

But the most important one from a regulatory standpoint is the MACE cardiovascular events because, as you recall, the current standard of care, the ESAs, have a black box warning for increased risk around those events in their label.

但從監管的角度來看，最重要的一個是 MACE 心血管事件，因為正如您所記得的那樣，當前的護理標準 ESA 在其標籤中有一個黑框警告，警告這些事件的風險增加。

So you have the answer pretty soon, Richard.

所以你很快就會得到答案，理查德。

But based on the data we have, I mean, we haven't seen anything that makes us believe that the little signal in this small population, small study, is actually real.

但根據我們擁有的數據，我的意思是，我們還沒有看到任何讓我們相信這個小群體、小型研究中的小信號實際上是真實的。

So let me close by saying that we are definitely at a turning point.

最後，讓我說我們絕對處於一個轉折點。

It's an important inflection point.

這是一個重要的轉折點。

We're back to growth.

我們恢復了增長。

Just like to remind you what that growth was in Q3, more than 9%.

只是想提醒你第三季度的增長是多少，超過 9%。

So we clearly are swinging back to growth.

因此，我們顯然正在恢復增長。

And that growth is driven by all our new products.

這種增長是由我們所有的新產品推動的。

And they're gaining momentum.

他們正在獲得動力。

They're growing faster and faster.

他們的成長速度越來越快。

Remember, Imfinzi, basically sales you see here are only the U.S. Tagrisso is more than the U.S. but many countries not even have reimbursement for first line yet, so there's a lot more to come, many new indications.

記住，Imfinzi，基本上你在這裡看到的銷售額只有美國。Tagrisso 比美國多，但許多國家甚至還沒有一線報銷，所以還有更多，許多新適應症。

So we really are at a inflection point.

所以我們確實處於一個轉折點。

China continues to do well.

中國繼續表現良好。

The Emerging Markets are doing well.

新興市場表現良好。

So that's one message: we're back to growth.

所以這是一個信息：我們恢復了增長。

The second message I wanted to leave you with is that we're definitely committed to improving operating margin over the next period of time and drive an increase in our operating cash flow, underlying cash flow, if you will.

我想給你留下的第二條信息是，我們絕對致力於在接下來的一段時間內提高營業利潤率，並推動我們的營業現金流量和基礎現金流量的增加，如果你願意的話。

And so we're going to move as we always said from the period of time when externalization was supporting cash flow to a period of time when the cash flow comes from the underlying business.

因此，正如我們一直所說的那樣，我們將從外部化支持現金流的時期轉移到現金流來自基礎業務的時期。

We're committed to doing these.

我們致力於做到這些。

We're committed to the operating margin.

我們致力於營業利潤率。

You've got to believe this.

你必須相信這一點。

And hopefully, you will agree, so far we've done what we told you we would do.

希望您會同意，到目前為止，我們已經完成了我們告訴您我們會做的事情。

It's not always been easy.

這並不總是那麼容易。

We also had a few setbacks along the way.

一路上我們也遇到了一些挫折。

But by and large, we have delivered the pipeline.

但總的來說，我們已經交付了管道。

We're launching those products, and they're doing very well.

我們正在推出這些產品，它們做得很好。

So the next period for us is really operating margin, and we'll make this happen.

所以下一個時期對我們來說真的是營業利潤率，我們會做到這一點。

With this, I'll thank you again for your attention and your great interest, and I wish you a good rest of the day.

在此，再次感謝您的關注和極大的興趣，祝您今天休息愉快。