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Operator
Operator
Good afternoon.
下午好。
Welcome, ladies and gentlemen, to AstraZeneca's Q3 results analyst's conference.
女士們,先生們,歡迎參加阿斯利康第三季度業績分析師會議。
Before I hand over to Pascal Soriot, I'd like to read the Safe Harbor statement.
在我交給 Pascal Soriot 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 these forward-looking statements.
公司不承擔更新這些前瞻性陳述的義務。
I will now hand you over to Pascal Soriot.
我現在將把你交給 Pascal Soriot。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Hello, everyone.
大家好。
This is Pascal Soriot; I am the CEO of AstraZeneca.
這是 Pascal Soriot;我是阿斯利康的首席執行官。
Welcome to the Q3 results conference call for investors and analysts.
歡迎參加面向投資者和分析師的第三季度業績電話會議。
Our slides are posted online for you to download, and follow.
我們的幻燈片在線發布,供您下載和關注。
I am joined today by Marc Dunoyer, our CFO; Luke Miels, our EVP for Global Product and Portfolio Strategy; and Sean Bohen, our new Executive Vice President for Global Medicines Development, and our CMO.
今天,我們的首席財務官 Marc Dunoyer 加入了我的行列; Luke Miels,我們的全球產品和投資組合戰略執行副總裁;和 Sean Bohen,我們的新任全球藥物開發執行副總裁兼我們的首席營銷官。
In addition, we have other key members of the AstraZeneca team ready for your questions.
此外,我們還有阿斯利康團隊的其他主要成員準備好回答您的問題。
We have Paul Hudson, EVP Head of North America; Elisabeth Bjork, our Clinical Development Head for CV Metabolism; and Mondher Mahjoubi, the head of strategic business, Oncology.
我們有北美執行副總裁 Paul Hudson; Elisabeth Bjork,我們的 CV 代謝臨床開發負責人;以及腫瘤學戰略業務負責人 Mondher Mahjoubi。
It's great to have so many of you present today, despite competing events.
很高興今天有這麼多人出席,儘管有競爭性的活動。
And we look forward to taking you through the results and achievements so far in 2015; and, importantly, we look forward to the Q&A session.
我們期待著帶您了解 2015 年迄今為止的成果和成就;而且,重要的是,我們期待著問答環節。
Before we get started, this is the usual Safe Harbor statement.
在我們開始之前,這是通常的安全港聲明。
But please turn now to slide 3. The plan today is for me to provide a short introduction and a summary.
但請現在轉到幻燈片 3。今天我的計劃是提供一個簡短的介紹和總結。
I will then hand over to Luke for an update on our growth platforms and our products.
然後我將交給 Luke,了解我們的增長平台和產品的最新情況。
Marc will cover the financials and the guidance.
馬克將負責財務和指導。
Sean will provide a pipeline update.
Sean 將提供管道更新。
And I will end with concluding remarks, before we take your questions.
在我們回答您的問題之前,我將以結束語結束。
We plan to have about 30 minutes for the presentation, and a similar amount of time for Q&A, so one hour in total.
我們計劃有大約 30 分鐘的演示時間,以及大約 30 分鐘的問答時間,因此總共需要 1 小時。
For the Q&A, I kindly remind participants to limit questions to one or two per person, so we have time for everyone.
對於問答環節,我謹提醒參與者將問題限制在每人一到兩個以內,以便我們為每個人留出時間。
We can do a second round, too, if necessary.
如有必要,我們也可以進行第二輪。
Turning to slide 4, within the results today, total revenue was stable at $18.3 billion, year to date.
轉到幻燈片 4,在今天的結果中,年初至今的總收入穩定在 183 億美元。
We are pleased with this performance, and the resilience of our top line, despite ongoing patent expiries, and competition from generic products that are creating substantial headwinds for us.
我們對這種表現和我們的收入的彈性感到滿意,儘管專利持續到期,並且來自仿製藥的競爭給我們帶來了巨大的阻力。
The growth platforms grew double-digit at 10% in the year to date, and now represents 57% of our total revenue.
今年迄今為止,增長平台以 10% 的速度增長了兩位數,目前占我們總收入的 57%。
Core EPS was up 2% in the year to date.
今年迄今為止,核心每股收益增長了 2%。
But, more importantly, we were up 8% in the quarter [here], reflecting an increase in gross margin, but also the management of our SG&A expenses.
但更重要的是,我們在本季度 [此處] 增長了 8%,這反映了毛利率的增長,以及我們對 SG&A 費用的管理。
We delivered strong news flows from the pipeline in the third quarter, including one new approval and several regulatory submission acceptances.
我們在第三季度發布了來自管道的強勁消息,包括一項新的批准和多項監管提交的接受。
The importance of our new medicines was highlighted by the granting of priority reviews, accelerated assessment in number of FDA fast-track designations.
我們的新藥的重要性通過授予優先審評、加速評估 FDA 快速通道指定數量得到強調。
Further, based on our performance so far this year, we've upgraded to the full-year CER guidance as we see total revenue now being much more in line with last year, and core EPS increasing by mid to high single-digit percent.
此外,根據我們今年迄今為止的表現,我們已經升級到全年 CER 指導,因為我們看到總收入現在與去年更加一致,核心每股收益增長了中高個位數百分比。
Marc will provide more details later on.
Marc 稍後將提供更多詳細信息。
Turning to slide 5, and looking at the third quarter, there was continuous strong pipeline news flows.
轉到幻燈片 5,看看第三季度,不斷有強勁的管道新聞流。
Brilinta was approved in the US for the treatment beyond one year, based on data from the PEGASUS study.
根據 PEGASUS 研究的數據,Brilinta 在美國被批准用於超過一年的治療。
As you would expect in our industry, some projects go well and others suddenly you can face setback.
正如您在我們的行業中所期望的那樣,有些項目進展順利,而另一些項目則可能會突然遭遇挫折。
We did receive a complete response letter from the FDA for saxa/dapa, and we are currently assessing exactly what needs to be covered, before we can bring this medicine to patients in the US.
我們確實收到了 FDA 對 saxa/dapa 的完整回复信,我們目前正在評估需要涵蓋的確切內容,然後才能將這種藥物帶給美國的患者。
It's important to remember that, in the meantime, we are pursuing approvals in Europe, and elsewhere.
重要的是要記住,與此同時,我們正在歐洲和其他地方尋求批准。
And we'll hear more about that in 2016.
我們將在 2016 年聽到更多相關信息。
Sean will provide more details later, but it was reassuring that this complete response letter didn't refer to heart failure for saxa/dapa, or diabetes ketoacidosis for the SGLT-2 class.
肖恩稍後將提供更多細節,但令人欣慰的是,這封完整的回复信沒有提到 saxa/dapa 的心力衰竭,或 SGLT-2 類的糖尿病酮症酸中毒。
More to come during Sean's presentation.
肖恩的演講期間還有更多內容。
PT003, Brilinta, and AZD9291 all received regulatory submission acceptances in various geographies.
PT003、Brilinta 和 AZD9291 都獲得了不同地區的監管提交驗收。
And 9291 received priority reviews in the US and Japan, and accelerated assessment in the EU.
並且9291在美國和日本獲得了優先審評,在歐盟獲得了加速評估。
Further, we received FDA fast-track designation for anifrolumab, tremelimumab, and durvalumab.
此外,我們還獲得了 FDA 對 anifrolumab、tremelimumab 和 durvalumab 的快速通道指定。
So, quite a rich news flow for the quarter.
因此,本季度的新聞流相當豐富。
Please turn to slide 6. Total revenue was stable year to date, down 2% in Q3, reflecting the ongoing patent expiries and the generic competition, as well as a lower level of externalization revenue compared to previous quarters this year.
請轉到幻燈片 6。今年迄今總收入穩定,第三季度下降 2%,反映了持續的專利到期和仿製藥競爭,以及與今年前幾個季度相比較低水平的外部化收入。
Our growth platforms continued to perform well, growing by 10% in the year to date; and they now represent 57% of total revenue.
我們的增長平台繼續表現良好,今年迄今增長了 10%;他們現在佔總收入的 57%。
We continued to manage SG&A cost while investing in R&D expenses that grew by 22% year to date, and we started new trials in oncology and elsewhere, including COPD and lupus.
我們繼續管理 SG&A 成本,同時投資研發費用,今年迄今為止增長了 22%,我們開始了腫瘤學和其他領域的新試驗,包括 COPD 和狼瘡。
We continued to have a very rich late-stage pipeline with 15 new molecular entities in Phase III, or under registration.
我們繼續擁有非常豐富的後期管道,有 15 個新分子實體處於 III 期或正在註冊中。
And we support those through this R&D budget increase.
我們通過增加研發預算來支持這些。
We expect, however, R&D costs for the full year to remain in growth mode, but moderate next year; and we would see 2016 R&D costs to be broadly in line with 2015.
然而,我們預計全年研發成本將保持增長模式,但明年將放緩;我們預計 2016 年的研發成本與 2015 年大致持平。
We expect this year SG&A costs will decline versus last year, as we told you earlier this year we would deliver.
正如我們今年早些時候告訴您的那樣,我們預計今年的 SG&A 成本將比去年有所下降。
More to come, during Marc's presentation.
在馬克的演講期間,還有更多內容。
We leveraged our stable revenues down the P&L with the core gross margin up by 1 percentage point so far this year.
今年到目前為止,我們利用穩定的收入來降低損益,核心毛利率上升了 1 個百分點。
Core EPS for the year to date grew 2%.
今年迄今為止的核心每股收益增長了 2%。
Importantly, we grew 8% in the quarter, which supports our upgraded guidance.
重要的是,本季度我們增長了 8%,這支持了我們升級後的指引。
So, to sum up, given the top-line resilience and the SG&A management, we've been able to continue investing in R&D, but still deliver on our core EPS growth.
因此,總而言之,鑑於頂線彈性和 SG&A 管理,我們能夠繼續投資於研發,但仍能實現我們的核心 EPS 增長。
The results today provide reassurance about our ability to fund R&D investment without negatively impacting earnings.
今天的結果再次保證了我們在不對收益產生負面影響的情況下為研發投資提供資金的能力。
And this will be important as we move into 2016.
隨著我們進入 2016 年,這將很重要。
However, medium term, the continued performance of our platforms and our upcoming launches will combine with our increasing focus on cost and cash generation to help us fight short-term headwinds and return our Company to sustainable growth.
然而,從中期來看,我們平台的持續表現和即將推出的產品將結合我們對成本和現金生成的日益關注,以幫助我們應對短期逆風並使我們的公司恢復可持續增長。
With this, I'll hand over to Luke.
有了這個,我會交給盧克。
Luke Miels - EVP, GPPS, Global Medical Affairs, and Corporate Affairs
Luke Miels - EVP, GPPS, Global Medical Affairs, and Corporate Affairs
Thanks, Pascal.
謝謝,帕斯卡。
And if we could just go to slide 8, please.
請轉到幻燈片 8。
Starting with the growth platforms, we had the headline progress across all markets; and that's exactly what we saw in Q3, which is encouraging.
從增長平台開始,我們在所有市場都取得了重大進展;這正是我們在第三季度看到的,令人鼓舞。
These main therapeutic areas and fast-growing geographies are the key contributors to returning the Company to steady growth, and to achieving our medium- and long-term revenue targets.
這些主要治療領域和快速增長的地區是公司恢復穩定增長和實現我們的中長期收入目標的關鍵因素。
Over the course of the next few slides, I'll review each of these in more detail.
在接下來的幾張幻燈片中,我將更詳細地回顧每一個。
But overall, respiratory was driven by strength in emerging markets, plus the new products.
但總的來說,呼吸是由新興市場的實力以及新產品推動的。
Brilinta made an important regulatory stride in the quarter, on the heels of the positive PEGASUS study results.
在 PEGASUS 研究取得積極成果之後,Brilinta 在本季度取得了重要的監管進展。
Diabetes was driven by the progression of strong launches, and our global footprint.
糖尿病是由強大的發布進展和我們的全球足跡推動的。
And it may be the fastest-growing global diabetes franchise at the moment.
它可能是目前增長最快的全球糖尿病專營權。
Emerging markets showed notable strength, particularly in China.
新興市場表現出顯著的實力,尤其是在中國。
And finally, Japan maintained solid growth in the third quarter.
最後,日本在第三季度保持穩健增長。
If we go to respiratory, on the next slide, you'll see respiratory grew by 8% year to date, driven by the strong performance of our emerging markets business; and also, the availability of new products in the US and the EU.
如果我們轉到呼吸系統,在下一張幻燈片中,您會看到呼吸系統今年迄今增長了 8%,這得益於我們新興市場業務的強勁表現;此外,新產品在美國和歐盟的可用性。
We believe this is comfortably ahead of global market growth of around 5%.
我們認為這遠遠超過全球市場 5% 左右的增長率。
If we look specifically at Symbicort, it declined by 2% year to date.
如果我們特別關注 Symbicort,它今年迄今下降了 2%。
In the US, sales were down 1%, with volume growth offset by additional access and copay assistant after formulary changes at the beginning of the year.
在美國,銷售額下降了 1%,銷量增長被年初處方變更後額外的訪問和共付額助手所抵消。
And this is what we discussed in Q1 and Q2.
這就是我們在第一季度和第二季度討論的內容。
Symbicort achieved share growth every month since February, and in September achieved an all-time high for total prescription share.
自 2 月以來,Symbicort 的份額每月都在增長,9 月份的總處方份額創下歷史新高。
The maintenance of positive volume in growth of the share in the US speaks to the strength and resilience of this medicine in the eyes of doctors and patients, and device loyalty.
在美國的份額增長中保持正銷量說明了這種藥物在醫生和患者眼中的實力和彈性,以及設備忠誠度。
For Europe, a different set of dynamics.
對於歐洲,情況不同。
The business remains impacted by the three analogs now on the market, but we have a pretty good picture of what is at play there.
該業務仍然受到目前市場上三種類似物的影響,但我們對那裡的影響有一個很好的了解。
Symbicort and Pulmicort both have notable growth in emerging markets, particularly in China.
信必可和普米克在新興市場都有顯著增長,尤其是在中國。
And China, specifically, represents an opportunity with a large unmet need in terms of untreated patient populations, both in asthma, but also COPD.
尤其是中國,在未經治療的患者群體方面,無論是哮喘還是慢性阻塞性肺病,都代表著一個巨大的未滿足需求的機會。
Pulmicort was up 47% and remains our leading product in China by sales.
普米克上漲了 47%,按銷售額計算,它仍然是我們在中國的領先產品。
Substantial growth potential continues to exist in the market with trends shifting from acute treatment to chronic maintenance treatment; the treatment expansion from large tier cities to more rural and community-based treatment centers.
隨著趨勢從急性治療轉向慢性維持治療,市場繼續存在巨大的增長潛力;治療從大城市擴展到更多的農村和社區治療中心。
As for the new products, Tudorza and Eklira saw nice progress in the US and Europe, and also the fastest-growing line of bronchodilators in some markets.
至於新產品,Tudorza 和 Eklira 在美國和歐洲取得了不錯的進展,並且在某些市場也是增長最快的支氣管擴張劑系列。
If we look at Duaklir, the dual LAMA/LABA, the launch is progressing well in about 15 markets where it's launched, and continues to gain share: up to 15% to 20%, depending on the market.
如果我們看一下雙 LAMA/LABA Duaklir,它在大約 15 個推出的市場中進展順利,並且繼續獲得份額:高達 15% 到 20%,具體取決於市場。
Next slide please, slide 10.
請下一張幻燈片,第 10 張幻燈片。
Brilinta, it was a good quarter.
Brilinta,這是一個很好的季度。
Brilinta grew by 44% year to date, with particular strength in emerging markets, and also the US.
Brilinta 今年迄今增長了 44%,在新興市場和美國表現尤為強勁。
In the US, approval was granted for the post-MI indication during the third quarter.
在美國,第三季度批准了 MI 後適應症。
It's an important milestone that underscores a role Brilinta can play in reducing the risk of subsequent cardiovascular events for patients both in the acute setting, and now in the longer term.
這是一個重要的里程碑,它強調了 Brilinta 在降低急性期和現在長期患者後續心血管事件風險方面的作用。
The expanded FDA label for Brilinta for post-MI patients also reinforced, critically, Brilinta's superiority over Plavix.
擴大 FDA 用於 MI 後患者的 Brilinta 標籤也強化了 Brilinta 相對於 Plavix 的優越性。
The launch took place in October.
發射發生在十月。
And there was some inventory benefit realized already in Q3, as we prepared for that launch.
在我們為發布做準備時,第三季度已經實現了一些庫存收益。
The halo effect of the US label will increase market share, currently at 10.1%, as you can see from the chart; and should also increase the duration of treatment with more patients now staying on therapy for longer.
美國標籤的光環效應將增加市場份額,目前為10.1%,如圖所示;並且還應該增加治療的持續時間,現在有更多的患者接受更長時間的治療。
We're also encouraged by the increasing awareness and confidence shown by prescribing physicians and the feedback given to us, following the label change.
在標籤更改後,開處方的醫生表現出的意識和信心的提高以及給我們的反饋也讓我們感到鼓舞。
In the EU, Brilinta reinforced its position as the standard of care in the ACS market.
在歐盟,Brilinta 鞏固了其作為 ACS 市場護理標準的地位。
And in Japan, regulatory submissions were completed, both to the ACS, and also the post-MI indications.
在日本,已完成向 ACS 以及 MI 後適應症的監管提交。
We move next to diabetes.
接下來是糖尿病。
If we look at the total portfolio, it was encouraging growth, 26% year to date.
如果我們看一下整個投資組合,它的增長令人鼓舞,今年迄今增長了 26%。
And it was driven by Forxiga, and also the Bydureon pen.
它由 Forxiga 和 Bydureon 筆驅動。
Geographically, emerging markets were up 73% year to date.
從地域上看,新興市場今年迄今增長了 73%。
Onglyza sales were up 2% globally, driven by Europe and emerging markets, and also Japan.
在歐洲和新興市場以及日本的推動下,Onglyza 的全球銷售額增長了 2%。
US sales were down 15% as the medicine continued to experience challenges from a competitive market, and also our very deliberate focus on Forxiga and the Bydureon dual-chamber pen.
美國銷售額下降了 15%,因為該藥物繼續面臨來自競爭激烈的市場的挑戰,而且我們非常有意地專注於 Forxiga 和 Bydureon 雙腔筆。
And finally, we still await the label update for Onglyza, following the April 2015 advisory committee meeting on the SAVOR trial.
最後,在 2015 年 4 月關於 SAVOR 試驗的諮詢委員會會議之後,我們仍在等待 Onglyza 的標籤更新。
For Forxiga, continued strong growth across all geographies, including the US, Europe, and emerging markets.
Forxiga 在所有地區(包括美國、歐洲和新興市場)持續強勁增長。
As we look into next year, we expect the US to soon benefit from improving pulmonary access and improvements around the patient access programs.
展望明年,我們預計美國將很快受益於肺部通路的改善和患者通路計劃的改進。
Bydureon sales growth was 38%, ahead of a growing market of GLP-1s, and reflected the successful launch of the dual-chamber pen.
Bydureon 的銷售額增長了 38%,領先於增長的 GLP-1 市場,這反映了雙腔筆的成功推出。
US conversion, from the single-dose tray to the pen, is around 60% of TRXs; up from 50% that we explained in the first half.
美國從單劑量托盤到筆的轉換率約為 TRX 的 60%;高於我們在上半年解釋的 50%。
Next slide.
下一張幻燈片。
Thanks.
謝謝。
For emerging markets, a balanced performance.
對於新興市場,表現均衡。
Double-digit growth continued in Q3.
第三季度繼續保持兩位數的增長。
China maintained double-digit growth, though at a slightly lower rate, with strong underlying market dynamics.
中國保持了兩位數的增長,儘管增長率略低,但具有強大的潛在市場活力。
Our expectation is to continue delivering strong growth in China.
我們的期望是繼續在中國實現強勁增長。
There was also notable growth outside of China.
中國以外的地區也有顯著增長。
Russia and Brazil are both growing ahead of the market, and at double-digit rates, with many other countries following at high single-digit rates.
俄羅斯和巴西都以兩位數的速度領先於市場增長,許多其他國家以高個位數的速度緊隨其後。
Emerging market growth overall was spread across all the main therapeutic areas, which we think is encouraging.
新興市場的整體增長遍及所有主要治療領域,我們認為這是令人鼓舞的。
Year to date, respiratory is up 32%; Brilinta up 93%; and diabetes up 73%; and, finally, as we start to focus more on it in preparation for the pipeline, oncology was up 19%.
今年迄今為止,呼吸上升了 32%; Brilinta 上漲 93%;和糖尿病上升了 73%;最後,隨著我們開始更加關注它以準備管道,腫瘤學上漲了 19%。
Next slide, please.
請換下一張幻燈片。
For Japan, maintained growth in Q3 with an increase in sales of 6%, and 3% year to date.
對於日本,第三季度保持增長,銷售額增長 6%,今年迄今增長 3%。
Key growth medicines were Symbicort, Nexium, and Crestor.
主要的生長藥物是 Symbicort、Nexium 和 Crestor。
And these all saw continued progress in Q3, and maintained leading market-share positions.
這些都在第三季度取得了持續進展,並保持了領先的市場份額。
In Q3, Symbicort was negatively impacted by the comparative year's, for 2014, strong performance as shipments in the first half of 2014 shifted into Q3.
在第三季度,Symbicort 受到了 2014 年同期強勁表現的負面影響,因為 2014 年上半年的出貨量轉移到了第三季度。
Nexium maintained its leading market position, despite increased competition.
儘管競爭加劇,Nexium 仍保持其領先的市場地位。
And Crestor benefited from increased usage of the 5 milligram dose.
Crestor 受益於 5 毫克劑量的增加使用。
We also progressed the pipeline in Q3.
我們還在第三季度推進了管道。
And we expect several regulatory milestones in Japan in 2016, including, for Brilinta, we submitted for ACS in the post-MI indications, and we anticipate being able to launch in Japan in 2016.
我們預計 2016 年日本將出現幾個監管里程碑,包括 Brilinta,我們在 MI 後適應症中提交了 ACS,我們預計能夠在 2016 年在日本上市。
Also, as planned, we submitted AZD9291 for regulatory approval, and obtained priority review.
此外,我們按計劃提交了 AZD9291 的監管批准,並獲得了優先審評。
This regulatory submission immediately followed the ones in the US and the EU by only one quarter.
該監管提交緊隨美國和歐盟的提交之後,僅落後四分之一。
And, just to place this in context, if we look at Crestor and Symbicort, the time lag between the US and EU was between 10 and 12 years.
而且,只是將其放在上下文中,如果我們看一下 Crestor 和 Symbicort,美國和歐盟之間的時間差在 10 到 12 年之間。
So, again, the focus on accelerated R&D in Japan is paying off.
因此,日本對加速研發的關注再次取得了成效。
I'd also like to thank the scientists and clinicians and product teams involved for their important contributions.
我還要感謝參與其中的科學家、臨床醫生和產品團隊的重要貢獻。
We all look forward to bringing this important oncology medicine to patients as soon as possible, potentially, ahead of the first half in 2016.
我們都期待在 2016 年上半年之前盡快將這一重要的腫瘤藥物帶給患者。
All in all, with the progress made, AstraZeneca's presence in Japan is expanding; and the Company now ranks seventh in the country, as you can see on the right-hand of the slide.
總而言之,隨著取得的進展,阿斯利康在日本的影響力正在擴大;公司現在在全國排名第七,如幻燈片右側所示。
On the next slide, new launches.
在下一張幻燈片上,新發布。
For an update on our most recent launches, starting with Lynparza, I think it's very fair to say there's a strong uptake in the US.
對於我們最近發布的更新,從 Lynparza 開始,我認為可以說在美國有很強的接受度是非常公平的。
Approximately 75% of the estimated 1,200 prevalent BRCA-tested fourth line patients are already treated with Lynparza.
在估計的 1,200 名流行的 BRCA 測試的四線患者中,大約 75% 已經接受了 Lynparza 治療。
BRCA testing rates have reached approximately 75% in the US, and they have now doubled in the EU to about one-third of patients.
在美國,BRCA 檢測率已達到約 75%,而在歐盟,BRCA 檢測率現在翻了一番,達到約三分之一的患者。
Sales in Europe are growing, and they now represent around 20% of total Lynparza sales.
歐洲的銷售額正在增長,目前約佔 Lynparza 總銷售額的 20%。
The product is now launched in around 10 countries, including emerging markets, with more than one in five -- sorry, with more than five more countries expected to launch in the final quarter.
該產品現已在包括新興市場在內的大約 10 個國家/地區推出,超過五分之一——抱歉,預計還有超過五個國家/地區將在最後一個季度推出。
We look forward to upcoming data on Lynparza in the program, potentially to expand the use of this important product.
我們期待該計劃中關於 Lynparza 的即將到來的數據,這可能會擴大這一重要產品的使用。
Turning to Iressa, it was approved in the US in July for first line use in metastatic EGFR-mutated lung cancer, with the first commercial sales recorded just a few days later.
談到易瑞沙,它於 7 月在美國獲准用於轉移性 EGFR 突變肺癌的一線治療,幾天后就實現了首次商業銷售。
Critically, the launch of Iressa has enabled us to accelerate the construction of our medical and commercial capability, which we expect to actively deploy prior to the launch of 9291.
至關重要的是,易瑞沙的推出使我們能夠加快構建我們的醫療和商業能力,我們希望在 9291 推出之前積極部署。
Finally, Movantik continues a good trajectory in the US.
最後,Movantik 在美國繼續保持良好的發展軌跡。
I'm encouraged by the broad awareness level that has led to trials, and good repeat scripts, and more expansive use.
我對導致試驗、良好的重複腳本和更廣泛的使用的廣泛意識水平感到鼓舞。
Importantly, the patient experience has been very positive, and the abandonment rate is very low.
重要的是,患者體驗非常好,放棄率非常低。
Finally, the product has been made available to patients in Nordic countries, with recent additional launches in the UK, Ireland, Germany, and Canada.
最後,該產品已提供給北歐國家的患者,最近又在英國、愛爾蘭、德國和加拿大推出。
Overall, year to date, and in Q3, our main therapeutic areas and geographic areas have focused, delivered steady growth.
總體而言,今年迄今為止,在第三季度,我們的主要治療領域和地理區域得到了重點關注,實現了穩定增長。
With this, I'll now hand over to Marc for the financials.
有了這個,我現在將財務交給馬克。
Marc Dunoyer - CFO
Marc Dunoyer - CFO
Thanks, Luke.
謝謝,盧克。
Hello, everyone.
大家好。
I'm going to spend the next few minutes taking you through our financial headlines, and the upgraded guidance for 2015.
我將在接下來的幾分鐘內向您介紹我們的財務頭條新聞以及 2015 年的升級指南。
Please turn to slide 16.
請轉到幻燈片 16。
Looking at the year to date, we delivered another robust performance.
回顧今年迄今為止,我們又取得了強勁的業績。
As Pascal said, total revenues were stable over the year to date.
正如 Pascal 所說,今年迄今為止的總收入穩定。
Externalization revenue represented about 5% of the top line.
外部化收入約佔總收入的 5%。
As we continue to experience high R&D productivity and focus on three main therapeutic areas, the externalization revenue will remain important in 2016.
由於我們繼續體驗高研發生產力並專注於三個主要治療領域,外化收入在 2016 年仍將很重要。
Our gross margin improved further, this time to over 83% of year-to-date product sales, reflecting the mix, as well as manufacturing efficiencies.
我們的毛利率進一步提高,這次達到了年初至今產品銷售額的 83% 以上,反映了產品組合以及製造效率。
Core SG&A declined by 3% in quarter 3, but increased by 2% in the year to date.
核心 SG&A 在第三季度下降了 3%,但今年迄今增長了 2%。
You may remember, however, the phasing of spend last year that was weighted toward the final quarter.
但是,您可能還記得去年的支出階段是在最後一個季度進行的。
We, therefore, remain fully confident of lowering core SG&A cost over the full year, both in value and in percentage of total revenue.
因此,我們仍然完全有信心在全年降低核心 SG&A 成本,無論是價值還是佔總收入的百分比。
The combination of top-line stability, the stronger gross margin, and a favorable outlook for core SG&A enabled us to continue the significant growth in core R&D investment in the period.
收入穩定、毛利率更高以及核心 SG&A 的良好前景相結合,使我們能夠在該期間繼續顯著增長核心研發投資。
The increase of 18% in the third quarter reflected the recent start of a number of clinical trials, in particular, in oncology.
第三季度 18% 的增長反映了最近開始的一些臨床試驗,特別是在腫瘤學方面。
The results today provide reassurance about AstraZeneca's ability to [further] our investment without negatively impacting earnings.
今天的結果讓我們確信阿斯利康有能力 [進一步] 我們的投資而不會對收益產生負面影響。
In a moment, I will take you through our fully-year guidance.
稍後,我將帶您了解我們全年的指導意見。
Please turn to slide 17.
請轉到幻燈片 17。
Turning to the P&L in more detail, the total revenue was stable year to date, but down 2% in quarter 3, reflecting the ongoing patent expiries and generic competition; as well as the low level of external revenue in the third quarter.
更詳細地轉向損益表,年初至今總收入穩定,但第三季度下降 2%,反映了持續的專利到期和仿製藥競爭;以及第三季度外部收入水平較低。
Encouraging progress is here in the cost of sales.
令人鼓舞的進步體現在銷售成本方面。
And our gross margin was accompanied by a 3% reduction in core SG&A cost in the third quarter.
第三季度,我們的毛利率伴隨著核心 SG&A 成本下降 3%。
This came on the back of a 1% decline in core SG&A costs in quarter 2.
這是因為第二季度核心 SG&A 成本下降了 1%。
The core tax rate fell to 16% in the year to date, after one-off benefit in the first half.
在上半年一次性受益後,今年迄今為止的核心稅率降至 16%。
Anticipated full-year tax rate to be in the lower half of the 16% to 20% range, outlined earlier in the year.
預計全年稅率將處於今年早些時候概述的 16% 至 20% 範圍的下半部分。
The 8% increase in core EPS in the third quarter supports today's upgrade to guidance.
第三季度核心每股收益增長 8% 支持今天對指導的升級。
Please turn to slide 18.
請轉到幻燈片 18。
Core SG&A cost reduction has been a focus for the business this year, and we have seen good progress.
降低核心 SG&A 成本一直是今年業務的重點,我們看到了良好的進展。
I'm pleased that we delivered a decline in the ratio of core SG&A to total revenue year to date versus fiscal year and full-year 2014.
我很高興與 2014 財年和全年相比,我們今年迄今核心 SG&A 佔總收入的比例有所下降。
Core SG&A costs also fell by 3% in the quarter, following the decline in quarter 2.
繼第二季度下降之後,本季度核心 SG&A 成本也下降了 3%。
As example of the actions we are taking, we continued to improve our sales, marketing, and medical effectiveness, which includes leveraging programs globally, rather than a country-by-country basis.
作為我們正在採取的行動的一個例子,我們繼續提高我們的銷售、營銷和醫療效率,其中包括在全球範圍內而不是在逐個國家/地區的基礎上利用計劃。
We also focus on centralizing select functions and processes to deliver standardization and economies of scale.
我們還專注於集中選擇功能和流程以實現標準化和規模經濟。
Please turn to slide 19.
請轉到幻燈片 19。
Turning to our upgraded guidance for 2015, total revenue is now expected to be in line with last year, given our performance over the last nine months.
談到我們升級後的 2015 年指引,鑑於我們過去九個月的表現,現在預計總收入與去年持平。
While maintaining good level of investment in R&D as more of our projects enter late stage, we expect core EPS to increase by mid to high single-digit percent this year.
隨著更多項目進入後期階段,在保持良好的研發投資水平的同時,我們預計今年核心每股收益將以中高個位數百分比增長。
These upgrades reflect the cumulative effect of, among other things, revenue stability; a strengthening gross margin; and successive reduction in core SG&A costs.
這些升級反映了收入穩定性等因素的累積效應;毛利率走強;以及核心 SG&A 成本的持續降低。
Although not guidance, we also try to help you to understand the impact of exchange rate movements in the year.
雖然不是指導,但我們也試圖幫助您了解當年匯率變動的影響。
Based on current exchange rates, total revenue is still expected to decline by high single-digit percent.
根據當前匯率,預計總收入仍將下降個位數百分比。
We continue to expect full-year core EPS, at current rates, to be broadly in line with 2014.
我們繼續預計全年核心每股收益(按當前匯率計算)將與 2014 年大致持平。
Given the increase in guidance at CER, this reflects a continued tough drag from global currencies versus the US dollar.
鑑於 CER 指引的增加,這反映出全球貨幣對美元的持續強勁拖累。
Thank you for listening.
謝謝你的聆聽。
And I will now hand over to Sean.
我現在將交給肖恩。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Thank you, Marc.
謝謝你,馬克。
It is a pleasure to be here speaking with you all today.
很高興今天能在這裡與大家交談。
I am both proud and excited to have taken over this role in September.
能夠在 9 月接任這一職務,我感到既自豪又興奮。
By way of introduction, I trained as an MD PhD at the University of California, San Francisco, and the National Cancer Institute; then, as an oncologist at Stanford.
作為介紹,我曾在加州大學舊金山分校和國家癌症研究所接受醫學博士培訓;然後,作為斯坦福大學的腫瘤學家。
I was previously at Genentech for 12 years, where I gained experience across the various phases of development in a broad spectrum of therapeutic areas.
我之前在 Genentech 工作了 12 年,在那裡我獲得了廣泛治療領域各個發展階段的經驗。
In the short few weeks since I've joined, I've been extremely impressed with the breadth and depth of the pipeline and high caliber of the individuals in the organization.
在我加入後的短短幾週內,我對管道的廣度和深度以及組織中個人的高素質印象深刻。
I would like to assure you that, together with the GMD team, we are committed to advancing the pipeline by pursuing a clearly defined science-led strategy to translate scientific knowledge to good clinical experiments to new medicines to benefit patients.
我想向您保證,與 GMD 團隊一起,我們致力於通過追求明確定義的科學主導戰略來推進管道,將科學知識轉化為良好的臨床實驗,再轉化為造福患者的新藥。
I welcome the challenge of executing our pipeline, and look forward to meeting many of you over the coming months.
我歡迎執行我們管道的挑戰,並期待在未來幾個月與你們中的許多人會面。
Please turn to slide 22.
請轉到幻燈片 22。
Next, I would like to review some late-stage pipeline highlights in our three main therapy areas for the third quarter.
接下來,我想回顧一下第三季度我們三個主要治療領域的一些後期管道亮點。
Starting with RIA, we received acceptance for the PT003 regulatory submission in the United States for COPD; and the detailed results for the Phase III trials were presented at the ERS Congress in Amsterdam, in September.
從 RIA 開始,我們在美國收到了針對 COPD 的 PT003 監管提交的接受; III 期試驗的詳細結果已於 9 月在阿姆斯特丹舉行的 ERS 大會上公佈。
In CVMD, Brilinta received approval in the US for the post-MI indication and regulatory submission acceptance for both the ACS and post-MI indications in Japan.
在 CVMD 中, Brilinta 在美國獲得了 MI 後適應症的批准,並在日本獲得了 ACS 和 MI 後適應症的監管提交接受。
As for saxa/dapa, we were disappointed to receive the complete response letter, which stated more clinical data are required to support the application.
至於 saxa/dapa,我們很失望地收到了完整的回复信,信中說需要更多的臨床數據來支持該申請。
No concerns were raised related to hospitalization for heart failure, or diabetic ketoacidosis.
沒有人擔心因心力衰竭或糖尿病酮症酸中毒而住院。
We will work closely with the FDA to determine the appropriate next steps, and remain committed to the program.
我們將與 FDA 密切合作,以確定適當的後續步驟,並繼續致力於該計劃。
As for Duaklir, our SGLT-2 outcome study, the trial is fully enrolled.
至於 Duaklir,我們的 SGLT-2 結果研究,該試驗已全部註冊。
Finally, for oncology, we received priority review designation in both the US and Japan, and accelerated assessment in the EU for AZD9291.
最後,在腫瘤學方面,我們在美國和日本都獲得了優先審評指定,並在歐盟獲得了 AZD9291 的加速評估。
We also received FDA fast-track designation for durvalumab, for head and neck cancer; and tremelimumab for mesothelioma.
我們還獲得了用於治療頭頸癌的 durvalumab 的 FDA 快速通道指定;和治療間皮瘤的 tremelimumab。
Q3 was a busy quarter for us and illustrates the steady progression, as well as our commitment, to the pipeline.
第三季度對我們來說是一個繁忙的季度,它說明了穩步的進展以及我們對管道的承諾。
Please turn to slide 23.
請轉到幻燈片 23。
Given a fast-evolving treatment landscape in immune-oncology, I wanted to provide some perspective over the 2015 to 2017 timeframe for the AstraZeneca portfolio and key ongoing trials.
鑑於免疫腫瘤學治療領域的快速發展,我想就 2015 年至 2017 年的阿斯利康產品組合和正在進行的關鍵試驗提供一些觀點。
By the end of the year, we expect data from the durvalumab ATLANTIC trial in third line PDL-1 positive non-small-cell lung cancer.
到今年年底,我們預計在三線 PDL-1 陽性非小細胞肺癌中的 durvalumab ATLANTIC 試驗數據。
The ATLANTIC study, as well as the HAWK study in second line PDL-1 positive head and neck cancer, are both single-arm Phase II trials designed as potential fast-to-market trials.
ATLANTIC 研究以及二線 PDL-1 陽性頭頸癌的 HAWK 研究都是單臂 II 期試驗,旨在作為潛在的快速上市試驗。
Assuming positive trials and unmet need in their intended indications, they could potentially lead to regulatory submissions in their respective settings.
假設在其預期適應症中進行積極的試驗和未滿足的需求,它們可能會導致在各自的環境中提交監管文件。
However, given the evolving treatment landscape in lung cancer, there is now a lower likelihood that ATLANTIC can be used for regulatory submission.
然而,鑑於肺癌治療領域的不斷發展,現在 ATLANTIC 可用於監管提交的可能性較低。
But we're still awaiting the data to make that determination.
但我們仍在等待數據來做出決定。
HAWK, in head and neck cancer, is expected to have data in the second half of 2016.
HAWK,在頭頸癌領域,預計2016年下半年會有數據。
Further, in monotherapy, specific in earlier-stage lung cancer, as well as the sub-study A of the ARCTIC trial in third line PD-L1 positive lung cancer, are both scheduled to report in 2017.
此外,針對早期肺癌的單一療法,以及針對三線 PD-L1 陽性肺癌的 ARCTIC 試驗的子研究 A,均計劃於 2017 年報告。
The DETERMINE trial of tremelimumab in second line mesothelioma is now expected to report in the first half of 2016.
tremelimumab 在二線間皮瘤中的 DETERMINE 試驗現在預計將於 2016 年上半年報告。
As with so many clinical trials, the final analysis of DETERMINE is event driven, and events have been coming in slower than anticipated.
與許多臨床試驗一樣,DETERMINE 的最終分析是事件驅動的,而且事件的進展比預期的要慢。
DETERMINE is a randomized Phase II with more than 500 patients in total.
DETERMINE 是一個隨機的 II 期試驗,總共有 500 多名患者。
Outside monotherapy, AstraZeneca is continuing to lead the efforts in combining IO medicines.
在單一療法之外,阿斯利康繼續領導聯合 IO 藥物的努力。
In particular, our anti-PD-L1 and anti-CTLA-4, durvalumab and tremelimumab, it's evident, from many data sets, that patients whose tumor does not express PD-L1 do not derive much benefit from monotherapy, but need a combination approach.
特別是我們的抗 PD-L1 和抗 CTLA-4、durvalumab 和 tremelimumab,從許多數據集中可以明顯看出,腫瘤不表達 PD-L1 的患者不會從單一療法中獲益太多,但需要聯合療法方法。
PD-L1 negative patients represent about two-thirds of our patients, and, thus, a very large opportunity to make a real difference in the treatment of their cancers.
PD-L1 陰性患者約占我們患者的三分之二,因此,這是一個非常大的機會,可以真正改變他們的癌症治療。
We have started [some] registrational studies of the durva-plus-treme combo, and are rapidly moving forward and consolidating our leading position in IO combinations.
我們已經開始[一些] durva-plus-treme 組合的註冊研究,並且正在迅速向前發展並鞏固我們在 IO 組合方面的領先地位。
The first studies will read out in 2017, including sub-study B of the ARTIC trial; as well as MYSTIC, our first line trial in non-small cell lung cancer.
第一批研究將於 2017 年宣讀,包括 ARTIC 試驗的子研究 B;以及 MYSTIC,這是我們針對非小細胞肺癌的一線試驗。
Similarly, in head and neck cancer, CONDOR is expected in 2017, as well.
同樣,在頭頸癌方面,CONDOR 也有望在 2017 年上市。
Please also watch out for updated durva-plus-treme data at the upcoming [CTSE] meeting.
另請注意在即將舉行的 [CTSE] 會議上更新的 durva-plus-treme 數據。
Just a few words on CAURAL and TATTEN.
簡單介紹一下 CAURAL 和 TATTEN。
As you know, there is a partial clinical hold on recruitment for these combination trials, but patients already enrolled can continue treatment after re-consent.
如您所知,這些聯合試驗的招募有部分臨床暫停,但已經入組的患者可以在重新同意後繼續治療。
There was an increased incidents of interstial lung disease with the combination therapy, as compared to each drug as a single agent, and we are working with regulatory authorities on how to monitor these events.
與每種藥物作為單一藥物相比,聯合治療會增加間質性肺病的發生率,我們正在與監管機構合作,研究如何監測這些事件。
There is no impact to ongoing discussions with regulatory authorities on AZD9291 approval.
與監管機構就 AZD9291批准進行的持續討論沒有影響。
In summary, as a newcomer to AstraZeneca, I am very impressed by the IO program; and, in particular, the combination work, where we are in leading position with durva and treme, as well as many earlier-stage programs.
綜上所述,作為阿斯利康的新人,我對 IO 項目印象非常深刻;尤其是組合工作,我們在 durva 和 treme 以及許多早期項目中處於領先地位。
And I am looking forward to keeping you updated on our continued progress here.
我期待著讓您了解我們在這裡的持續進展。
Please turn to slide 24.
請轉到幻燈片 24。
Between now and the end of 2016, we expect steady news flow from our advancing pipeline, including regulatory approvals, regulatory submissions, and Phase III readouts.
從現在到 2016 年底,我們預計我們推進中的管道將有穩定的消息流,包括監管批准、監管提交和 III 期讀出。
Focusing on events through the first half of next year, for regulatory approvals we expect to hear on lesinurad in the US in late December.
關註明年上半年的事件,我們預計 12 月下旬將在美國聽到 lesinurad 的監管批准。
And in the first half of 2016, AZD9291 has its official PUDUFA date, and EU anticipated approval for lung cancer; and PT003 its PUDUFA date for COPD in the US.
而在2016年上半年,AZD9291有正式的PUDUFA日期,歐盟有望批准用於肺癌;和 PT003 是美國 COPD 的 PUDUFA 日期。
As for key regulatory submissions, we expect to submit brodalumab for psoriasis by the end of this year; and in the first half of 2016 Brilinta in stroke, and durvalumab for lung cancer, and tremelimumab for mesothelioma.
至於關鍵的監管提交,我們預計將在今年年底提交用於銀屑病的 brodalumab; 2016 年上半年,Brilinta 治療中風,durvalumab 治療肺癌,tremelimumab 治療間皮瘤。
Our first potential entrants in immuno-oncology market.
我們在免疫腫瘤學市場的第一個潛在進入者。
As for key Phase III readouts, we expect durvalumab for lung cancer in the current quarter, and in the first half of 2016; tremelimumab for mesothelioma; benralizumab for severe asthmas; and Lynparza for metastatic breast cancer.
至於關鍵的 III 期讀數,我們預計本季度和 2016 年上半年肺癌的 durvalumab; tremelimumab 治療間皮瘤;用於嚴重哮喘的貝那利珠單抗;和 Lynparza 用於轉移性乳腺癌。
As you can see, there are many key data points expected in the coming months.
如您所見,預計未來幾個月將出現許多關鍵數據點。
To highlight our key late-stage pipeline programs, we will be hosting a late-stage pipeline conference call on December 2. We look forward to exploring these important programs in more depth at that time.
為了突出我們的關鍵後期管道項目,我們將於 12 月 2 日召開後期管道電話會議。我們期待屆時更深入地探索這些重要項目。
With that, I would like to hand back over to Pascal for closing comments.
有了這個,我想把結束評論交給 Pascal。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thank you, Sean.
謝謝你,肖恩。
And, again, a warm welcome to the AstraZeneca team; it's great to have you here with us today.
再次熱烈歡迎阿斯利康團隊;很高興今天有你和我們在一起。
Please turn to page 26.
請翻到第 26 頁。
I would like to summarize the year-to-date and Q3 results.
我想總結一下年初至今和第三季度的結果。
Total revenue was stable, despite the ongoing patent expiries and the generic competition, and they are strongly supported by our growth platforms.
儘管專利到期和仿製藥競爭持續,總收入還是穩定的,而且它們得到了我們增長平台的大力支持。
The core EPS was up 2%, up 8% in the quarter, as we managed SG&A costs.
由於我們管理了 SG&A 成本,本季度核心每股收益增長了 2%,增長了 8%。
But R&D investments increased to support our very rich pipeline.
但研發投資增加以支持我們非常豐富的產品線。
We saw very good news flow from the pipeline, and we are able to upgrade full-year 2015 guidance.
我們從管道中看到了非常好的消息,我們能夠升級 2015 年全年的指導。
We remain on track to deliver on our medium- and long-term goals.
我們仍有望實現我們的中期和長期目標。
With this, I would like to thank you for your attention.
感謝您的關注。
And I will now hand back over to the operator for Q&A.
我現在將交還給接線員進行問答。
For the Q&A.
對於問答。
I kindly remind participants to limit questions to one or two questions per person.
我謹提醒參與者將問題限制為每人一兩個問題。
so we have time for everyone.
所以我們有時間給大家。
Thank you so much for your cooperation.
非常感謝您的合作。
Operator, over to you.
接線員,交給你了。
Operator
Operator
(Operator Instructions).
(操作員說明)。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Maybe we can start with James Gordon, JPMorgan.
也許我們可以從摩根大通的詹姆斯戈登開始。
James Gordon - Analyst
James Gordon - Analyst
Two questions, please.
請教兩個問題。
The first one was about diabetes.
第一個是關於糖尿病的。
And the question was that last year you'd given a target for 2023 of [$8 billion] for diabetes.
問題是去年你為糖尿病設定了 2023 年 [80 億美元] 的目標。
And there's been a lot going on in diabetes in terms of side effect issues and regulatory.
在副作用問題和監管方面,糖尿病方面發生了很多事情。
My question is do you still see that as potentially achievable, that would mean that the business had to triple between now and then, or could that now be challenging?
我的問題是,您是否仍然認為這是可能實現的,這意味著業務必須從現在到那時增加三倍,或者現在這可能具有挑戰性嗎?
The second question was just on 2016.
第二個問題就在2016年。
Obviously, US Crestor generalization to navigate, there's a few different levers to get there: SG&A cuts, or divestment income, but also potentially a buyback, or doing a bolt on.
顯然,美國 Crestor 概括導航,有幾個不同的槓桿可以到達那裡:SG&A 削減,或撤資收入,但也可能回購,或做一個螺栓。
Just how do you think about the weighting of those different drivers?
您如何看待這些不同驅動因素的權重?
And could we see you actually [deploying] the balance sheet to help you get there?
我們能否看到您實際上 [部署] 資產負債表來幫助您實現目標?
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, James.
謝謝,詹姆斯。
Me to cover, first of all, the diabetes question.
我首先要討論糖尿病問題。
I think what I would like to say, first, is that we remain committed to our long-term goals.
我想我想說的是,首先,我們仍然致力於我們的長期目標。
In fact, we just finished our long-range planning process and we presented it to the Board this week, as we do every year.
事實上,我們剛剛完成了長期規劃流程,並在本週將其提交給了董事會,就像我們每年所做的那樣。
And I can tell you that our plan is very much in line with previous planning, and reflects that our 2023 goals are achievable, from our perspective.
我可以告訴你,我們的計劃與之前的計劃非常一致,從我們的角度來看,反映了我們 2023 年的目標是可以實現的。
Having said that, as you would imagine, in every plan you have ups and downs.
話雖如此,正如您想像的那樣,在每個計劃中都會有起有落。
What our planning reflects now is lower diabetes sales, but higher oncology sales.
我們的計劃現在反映的是糖尿病銷售額下降,但腫瘤銷售額上升。
If I talk about diabetes, in fact, we are doing better outside the US than we had expected originally.
如果我談論糖尿病,事實上,我們在美國以外的情況比我們最初預期的要好。
And in every emerging market I go to, I can tell you that when I ask people about their growth story their growth story is very much about diabetes.
在我去過的每個新興市場,我可以告訴你,當我詢問人們的成長故事時,他們的成長故事很大程度上與糖尿病有關。
So we're very delighted to have diabetes as part of our portfolio.
因此,我們很高興將糖尿病納入我們的投資組合。
We are a global company.
我們是一家全球性公司。
And even though every geography behaves a bit differently, and it's clear that diabetes is a bit of a competitive shield today in the US, outside the US there is enormous opportunities.
儘管每個地區的表現都略有不同,而且很明顯,糖尿病在當今美國是一種競爭盾牌,但在美國以外存在巨大的機會。
We do very well in Europe; and in the emerging markets, in particular, we do very well.
我們在歐洲做得很好;尤其是在新興市場,我們做得很好。
Got to realize, in those countries cancer, of course, is an issue.
必須意識到,在那些國家,癌症當然是一個問題。
But the big issues that they are dealing with today are cancer, hypertension, diabetes, COPD asthma.
但他們今天要處理的大問題是癌症、高血壓、糖尿病、COPD 哮喘。
Enormous opportunities in all of those, this is to help patients.
所有這些都有巨大的機會,這是為了幫助病人。
So, we do very well outside the US.
所以,我們在美國以外的地方做得很好。
In the US, we are, I would say, doing okay, but certainly not as well as we were expecting originally.
在美國,我想說,我們做得還不錯,但肯定不如我們最初預期的那麼好。
If you take the totality of global sales, we see less diabetes sales and we see more oncology sales, simply because we have more clinical data.
如果你拿全球銷售額的總和,我們看到糖尿病銷售額減少,我們看到腫瘤銷售額增加,僅僅是因為我們有更多的臨床數據。
We have launched [Laparit], so now we -- it's not a risk-adjusted forecast for Laparit, it's a full Laparit forecast.
我們已經推出了 [Laparit],所以現在我們 - 這不是 Laparit 的風險調整預測,而是完整的 Laparit 預測。
And then, we have more data from N2 and M1, so we become more confident with our oncology business.
然後,我們從 N2 和 M1 獲得了更多數據,因此我們對我們的腫瘤業務更有信心。
We've also, in the last year, recruited even more people around the world who understand oncology, so our forecast is even more robust that it was before.
去年,我們還在世界各地招募了更多了解腫瘤學的人,因此我們的預測比以前更加可靠。
That's kind of, if you want, the net-net of our forecasting, our long-range plan.
如果你願意的話,這就是我們預測的網絡,我們的長期計劃。
As far as US Crestor, and the pressures that are applied to our business, well, the way we deal with this is continued focus on managing our SG&A expenses.
就 US Crestor 以及我們業務所承受的壓力而言,我們處理這個問題的方式是繼續專注於管理我們的 SG&A 費用。
We reduced them in absolute value, and as a percentage of revenue.
我們降低了它們的絕對值和占收入的百分比。
As we said before, we'll continue to deliver externalization revenue.
正如我們之前所說,我們將繼續提供外部化收入。
And I think it's important to keep in mind those are here because our research engine is very productive.
我認為記住這些很重要,因為我們的研究引擎非常高效。
In fact, we cannot develop and commercialize everything that comes out of this research engine.
事實上,我們無法開發和商業化這個研究引擎產生的一切。
And we have said we're going to be disciplined and only pursue projects where we -- where they are in our core disease areas, oncology, CVMD [area].
我們已經說過,我們將遵守紀律,只在我們的核心疾病領域、腫瘤學、CVMD [領域] 開展項目。
And even -- so anything that is outside our core disease area, we partner, and we retain some long-term value.
甚至 - 所以我們的核心疾病領域之外的任何東西,我們都會合作,並且我們保留一些長期價值。
We also do it in core areas where we believe we don't have the -- we don't have the capabilities today, and hematology is a good example.
我們也在我們認為我們沒有的核心領域這樣做——我們今天沒有能力,血液學就是一個很好的例子。
So, externalization.
所以,外化。
And finally, the last thing is bolt-on.
最後,最後一件事是固定的。
Certainly, we'll pursue M&A and potential bolt-on.
當然,我們將尋求併購和潛在的補強。
And if we cannot do any -- if we cannot do those, certainly, we'll have to consider, or we will consider, share buyback.
如果我們不能做任何事情——如果我們不能做那些,當然,我們將不得不考慮,或者我們將考慮,股票回購。
But in term of how we deploy capital, our priority will be to pursue bolt-ons and M&A, so we can build long-term value, before we consider share buybacks.
但就我們如何部署資本而言,我們的首要任務是進行補強和併購,這樣我們才能在考慮股票回購之前建立長期價值。
Marc, anything you want to add?
馬克,你有什麼要補充的嗎?
Marc Dunoyer - CFO
Marc Dunoyer - CFO
No, I think you're absolutely right.
不,我認為你是完全正確的。
We constantly look at a share buyback, but we also benchmark them to potential opportunities we see outside.
我們不斷關注股票回購,但我們也會將它們與我們在外部看到的潛在機會進行比較。
And until now, our eyes have always been towards the bolt-ons.
直到現在,我們的目光一直集中在螺栓上。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Marc.
謝謝,馬克。
Jo Walton - Analyst
Jo Walton - Analyst
Jo Walton, Credit Suisse.
瑞士信貸的喬沃爾頓。
Two questions, please.
請教兩個問題。
One, going back to diabetes in the US, the Forxiga sales were actually lower in the third quarter than they were in the second quarter.
第一,回到美國的糖尿病,第三季度 Forxiga 的銷售額實際上低於第二季度。
I'm wondering if there's some element of competitive aspect that is important there.
我想知道是否有一些競爭方面的因素在那裡很重要。
Perhaps you could address whether there's any shift in patients away from commercial plans towards government plans, or whether this is just settling in of new promotional programs and we should start to see a strong acceleration.
也許你可以解決患者是否從商業計劃轉向政府計劃,或者這是否只是適應新的促銷計劃,我們應該開始看到強勁的加速。
The second question is one for Marc, please.
第二個問題是給 Marc 的。
I believe most of our -- most of the sell-side earnings per share numbers are fairly similar, but they may be made up in different ways.
我相信我們的大多數-大多數賣方每股收益數字都非常相似,但它們可能以不同的方式構成。
And one of the areas where our forecasts really are quite different is looking at the level of net debt at the end of this year, and at the end of next year.
我們的預測真正大不相同的一個領域是今年年底和明年年底的淨債務水平。
I wonder if you could just help us with some sense of actually how much cash is going out in restructuring, both in 2015, perhaps how much you've done this year to date, how much you expect for the whole year; and again, so that we get things right for 2016, how much more cash is going out in 2016.
我想知道您是否可以幫助我們了解一下 2015 年重組實際花費了多少現金,也許您今年迄今為止做了多少,您對全年的預期是多少;再說一次,為了讓我們在 2016 年做好準備,2016 年會有多少現金流出。
Many thanks.
非常感謝。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Jo.
謝謝,喬。
Maybe, Luke, you could cover the diabetes Forxiga question; and then, Marc, of course, the next one is for you.
也許,盧克,你可以解決糖尿病 Forxiga 問題;然後,馬克,當然,下一個是給你的。
Luke Miels - EVP, GPPS, Global Medical Affairs, and Corporate Affairs
Luke Miels - EVP, GPPS, Global Medical Affairs, and Corporate Affairs
Jo, I think there was an overall impact on the class with the signal that we're seeing with DKA in May and June, and the subsequent letter from regulators.
喬,我認為我們在 5 月和 6 月看到的 DKA 信號以及隨後來自監管機構的信函對班級產生了總體影響。
And you can really see that effect on the overall class.
你真的可以看到對整個班級的影響。
We, obviously, were impacted by that with Forxiga.
顯然,我們受到了 Forxiga 的影響。
If you look at the share trends, that volume was picked up by GLP-1s, which clearly we benefited from; and also by DPP4s, which we didn't.
如果您查看份額趨勢,就會發現 GLP-1 佔據了這一份額,顯然我們從中受益;還有 DPP4s,我們沒有。
I think as we look further out, clearly, there's some positive trends to SGLT-2s in terms of the infrared data.
我認為,當我們進一步觀察時,很明顯,SGLT-2 在紅外數據方面有一些積極的趨勢。
Also, in October we tightened up some of our access programs and affordability programs, particularly in terms of cash.
此外,在 10 月份,我們收緊了一些准入計劃和負擔能力計劃,特別是在現金方面。
In terms of movement between government and other programs, no, not a huge amount of movement.
就政府和其他項目之間的流動而言,不,不是大量的流動。
And again, just in terms of actual sales, it was around [$9 million].
再一次,就實際銷售額而言,大約是 [900 萬美元]。
Again, we remain confident about the class.
同樣,我們對班級仍然充滿信心。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
It's important to keep in mind, Jo, of course, as SGLT-2 class is a new class, and it's an innovative new class.
記住這一點很重要,喬,當然,因為 SGLT-2 課程是一個新課程,而且是一個創新的新課程。
And, of course, as with many new classes, you expect a few bumps in the road as you get started.
而且,當然,與許多新課程一樣,您在開始時會遇到一些顛簸。
If you go back to the statins, if you go back to Crestor when it was launched, we certainly experienced quite a number of eventful developments as we launched it, many years ago.
如果你回到他汀類藥物,如果你回到 Crestor 推出時,我們肯定在很多年前推出時經歷了相當多的重大發展。
If you look at the SGLT-2 class, in Japan, we've had, we, being the whole class, this issue of dehydration of patients that has really slowed down the class.
如果你看看 SGLT-2 班,在日本,我們整個班級都遇到了患者脫水的問題,這確實減慢了班級的進度。
But we see a pick up now.
但我們現在看到了回升。
It's a good class, and we believe it helps patients, and it will grow, and we see a pickup in Japan.
這是一個很好的課程,我們相信它可以幫助患者,而且它會成長,我們在日本看到了增長。
In the US, DKA has certainly slowed it down.
在美國,DKA 確實放慢了速度。
I believe that it's going to pick up again.
我相信它會再次回升。
Especially, this cardiovascular risk reduction is really the first time that you see it in an anti-diabetic class.
特別是,這種心血管風險降低在抗糖尿病課程中真的是第一次看到。
Marc?
馬克?
Marc Dunoyer - CFO
Marc Dunoyer - CFO
Yes, your first question on the net debt, I believe that for the end of September net debt will be about $5.8 billion.
是的,關於淨債務的第一個問題,我相信 9 月底的淨債務約為 58 億美元。
Then, your next question on the estimation of cash restructuring for 2015, it will be slightly inferior to $1 billion.
那麼,你的下一個問題,關於2015年現金重組的預估,會略低於10億美元。
And what we can say, as of today, for 2016, that the number should be slightly lower for 2016.
我們可以說,截至今天,對於 2016 年,2016 年的數字應該略低。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Marc.
謝謝,馬克。
There's an online question from Sachin Jain at BoA.
BoA 的 Sachin Jain 提出了一個在線問題。
Sachin is asking whether we have met with FDA regarding saxa/dapa FDC, and whether we have a better idea of what the delay might be.
Sachin 詢問我們是否就 saxa/dapa FDC 與 FDA 會面,以及我們是否對延遲可能有更好的了解。
Sean, the question is for you.
肖恩,這個問題是給你的。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Thank you, Sachin, for the question.
謝謝薩欽提出的問題。
The complete response letter, as I said, stated that we would need more clinical data to support the application.
正如我所說,完整的回复信表明我們需要更多的臨床數據來支持該申請。
We are committed to the saxa/dapa combo approval.
我們致力於 saxa/dapa 組合的批准。
And we have not yet met with the FDA.
我們還沒有與 FDA 會面。
As a result of that, we don't know exactly what more clinical data will be required, and that leads us to not being able to provide any clearer guidance with regard to how long the delay might be.
因此,我們不確切知道還需要哪些臨床數據,這導致我們無法就延遲多長時間提供更明確的指導。
We're hopeful to meet with them soon, and then we will have clarity around that.
我們希望盡快與他們會面,然後我們就會清楚這一點。
I think it's important to recognize that we do not believe that this particular complete response letter will affect filing outside the United States.
我認為重要的是要認識到,我們不認為這封完整的回复信會影響美國境外的申請。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Sean.
謝謝,肖恩。
Tim Anderson?
蒂姆·安德森?
Tim Anderson - Analyst
Tim Anderson - Analyst
Yes, a couple of pipeline questions, if I can.
是的,如果可以的話,有幾個管道問題。
You mentioned durvalumab and tremelimumab and the potential in lung, and I think you referenced some PD-L1 negative patients.
你提到了 durvalumab 和 tremelimumab 以及肺部的潛力,我認為你提到了一些 PD-L1 陰性患者。
I think the most recent data [set] from Bristol on nivolumab and ipilimumab showed the greatest efficacy, surprisingly, in PD-L1 positive patients, which came as a surprise.
我認為來自 Bristol 的關於 nivolumab 和 ipilimumab 的最新數據 [set] 顯示出最大的療效,令人驚訝的是,在 PD-L1 陽性患者中,這令人驚訝。
And it goes against what's been seen in the melanoma setting, with the combination of those two mechanisms.
這與這兩種機制的結合在黑色素瘤環境中看到的情況背道而馳。
I guess a question for Sean, perhaps, is how should we think about what seems to be discrepant data between Bristol's combo in PL-1 positive lung and your combo in PL-1 negative lung?
我想 Sean 的一個問題,也許是我們應該如何考慮 Bristol 的 PL-1 陽性肺組合與您的 PL-1 陰性肺組合之間似乎有差異的數據?
Then, second question on your OX40 program.
然後,關於您的 OX40 程序的第二個問題。
Looks like you terminated murine version of that antibody that's been in development for a long time.
看起來你終止了開發了很長時間的那種抗體的小鼠版本。
It was odd to have a murine antibody in development, but you said you would pursue it as a tool to learn about the class.
開發鼠類抗體很奇怪,但您說您會追求它作為了解課程的工具。
I'm wondering what you did learn, and why the sudden termination of the program?
我想知道你到底學到了什麼,為什麼突然終止這個項目?
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Two questions for Sean.
肖恩的兩個問題。
Maybe, quickly, the (inaudible), just to remind of the CTSE meeting this week look at this data, Tim.
也許,很快,(聽不清),只是為了提醒本週的 CTSE 會議看看這個數據,蒂姆。
Sean, go ahead.
肖恩,繼續。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Yes, Tim, the question will probably be a little easier for me to get into after tomorrow.
是的,蒂姆,明天之後我可能會更容易回答這個問題。
In the [murine], the CTSE meeting, we will present some early data, I think intriguing, on the PD-L1 negative non-small cell lung cancer and the durva/treme combo.
在 [小鼠] CTSE 會議上,我們將展示一些關於 PD-L1 陰性非小細胞肺癌和 durva/treme 組合的早期數據,我認為這很有趣。
How to think about the difference between the different molecules, I'd say they're dosed quite differently.
如何考慮不同分子之間的差異,我會說它們的劑量完全不同。
I think one of the things the world is dealing with is trying to figure out the way PD-L1 negative and PD-L1 positive are defined, and I think we're going to have to work with that as well.
我認為世界正在處理的事情之一是試圖弄清楚 PD-L1 陰性和 PD-L1 陽性的定義方式,我認為我們也將不得不處理這個問題。
There are number of variables there, but I think the conversation will be richer after we've made the data public.
那裡有很多變數,但我認為在我們公開數據後,對話會更加豐富。
The murine OX40 antibody, it is terminated -- it's really terminated and replaced by the molecule that is human.
小鼠 OX40 抗體,它被終止了——它真的被人類分子終止並取而代之。
That provides, I think, some pretty obvious advantages as we move that forward in development.
我認為,隨著我們在開發中向前推進,這提供了一些非常明顯的優勢。
We have shared most of the data that we have on that murine molecule already.
我們已經分享了關於該鼠類分子的大部分數據。
I think it has given us some idea of what we might look for as we move forward with the molecule that's currently in development.
我認為它讓我們了解了我們在推進目前正在開發的分子時可能會尋找什麼。
But it's terminated -- I think it's really switched to what we believe is a superior molecule for that particular target.
但它已經終止了——我認為它真的轉向了我們認為是針對特定目標的優質分子。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Sean.
謝謝,肖恩。
And it was always the plan.
這一直是計劃。
As you highlighted, Tim, we were never going to take three molecules in the clinic.
正如你強調的那樣,蒂姆,我們永遠不會在診所服用三個分子。
We always said we are going to take only one, and it was unlikely to be the murine one, of course, for obvious reasons.
我們總是說我們只會拿一隻,當然,它不太可能是鼠類的,原因很明顯。
Nicolas Guyon, Morgan Stanley.
尼古拉斯·蓋恩,摩根士丹利。
Nicolas Guyon - Analyst
Nicolas Guyon - Analyst
Thanks for taking my questions I have two, please.
謝謝你提出我的問題,請問我有兩個問題。
The first one is one saxa/dapa.
第一個是 saxa/dapa。
Obviously, you've been pretty clear as to which concerns the FDA did not raise in their complete response letter, i.e., increase risk of hospitalization for heart failure and diabetes ketoacidosis.
顯然,您已經很清楚 FDA 在其完整回复信中沒有提出哪些問題,即增加因心力衰竭和糖尿病酮症酸中毒住院的風險。
Any chance you could be a bit more specific about which concerns it did raise?
您是否有機會更具體地說明它確實引起了哪些擔憂?
Is it a problem related to manufacturing, efficacy, safety, or dosing?
這是與製造、功效、安全性或劑量相關的問題嗎?
My second question is on durvalumab.
我的第二個問題是關於 durvalumab。
I've seen that a Phase III in first line head and neck is in preparation, called the KESTREL trial.
我已經看到一線頭頸部的 III 期正在準備中,稱為 KESTREL 試驗。
Could you please elaborate on the design of that trial; and notably, whether you will include those HPV positive and negative patients, and whether other criteria could be important?
您能否詳細說明該試驗的設計?值得注意的是,你們是否會包括那些 HPV 陽性和陰性患者,以及其他標準是否重要?
Thank you.
謝謝你。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Nicolas, can you -- the second question, the first line, the study name (multiple speakers).
Nicolas,你能——第二個問題,第一行,研究名稱(多人發言)。
KESTREL, got it.
紅隼,明白了。
Sorry, I missed that.
對不起,我錯過了。
Maybe I could quickly cover the saxa/dapa question.
也許我可以快速解決 saxa/dapa 問題。
And maybe, Sean, if you have anything you want to add, please add; and I'll ask you to cover the second -- the other question.
肖恩,如果你有什麼想補充的,請補充;我會請你回答第二個問題——另一個問題。
The saxa/dapa, Nicolas there is no real serious concern attached to the questions.
saxa/dapa,Nicolas 並沒有真正認真地關注這些問題。
They're more to do with producing clinical data supporting the combination of the various dosage regimens.
他們更多地與產生支持各種劑量方案組合的臨床數據有關。
We can't be a lot more specific than this because we haven't met the FDA.
我們不能比這更具體,因為我們還沒有遇到 FDA。
We need to understand exactly what they expect of us.
我們需要準確了解他們對我們的期望。
But it has nothing to do with any safety adverse events, like [NKK], or (inaudible), has nothing to do with CMC.
但它與任何安全不良事件無關,如 [NKK] 或(聽不清)與 CMC 無關。
It's really purely producing the clinical data that they need to see to approve the fixed dose combination across both these regiment.
這真的純粹是在產生他們需要看到的臨床數據,以批准這兩個團的固定劑量組合。
We need to talk to them before we can answer specifically, because the important part is to understand how long it's going to take to produce those data.
我們需要先與他們交談,然後才能具體回答,因為重要的部分是了解生成這些數據需要多長時間。
Elisabeth, anything, since you are here?
伊麗莎白,既然你在這裡,有什麼事嗎?
Elisabeth is our Head of Development for diabetes.
Elisabeth 是我們的糖尿病開發主管。
Anything you want to add, Elisabeth?
伊麗莎白,你有什麼要補充的嗎?
Elisabeth Bjork - VP, Head of Cardiovascular & Metabolic Diseases
Elisabeth Bjork - VP, Head of Cardiovascular & Metabolic Diseases
No, I think you describe it very, very clearly, Pascal.
不,我認為你描述得非常非常清楚,Pascal。
And we will hopefully meet with the FDA very soon and get a clearer picture around the amount of clinical data we need to produce, and how long time that will take.
我們希望很快會與 FDA 會面,並更清楚地了解我們需要產生的臨床數據量以及需要多長時間。
And then, we will get back and update everybody around that.
然後,我們將返回並更新周圍的每個人。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
So, Sean, the durva question for you.
所以,肖恩,你的 durva 問題。
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Yes, so the KESTREL -- I think I'm going to call it a durva/ treme combo question.
是的,所以 KESTREL -- 我想我會稱它為 durva/treme 組合問題。
The KESTREL trial is a squamous cell carcinoma of the head and neck in the frontline.
KESTREL 試驗是一線的頭頸部鱗狀細胞癌。
And the trial, the Phase III trial, randomized has got three arms.
而這項試驗,即 III 期試驗,隨機分配了三組。
The arms are MEDI-4736 durvalumab as a single agent; second arm is the durva/treme combo; and then, the third arm of that trial is standard of care as the control.
手臂是 MEDI-4736 durvalumab 作為單一藥物;第二臂是 durva/treme 組合;然後,該試驗的第三組是標準護理作為對照。
And, I must admit, I am not -- I don't recall any exclusion of HPV carrier patients on that trial, so we might have to get back to you with the specific information on that.
而且,我必須承認,我不是——我不記得在該試驗中有任何排除 HPV 攜帶者患者的情況,因此我們可能不得不就此向您提供具體信息。
My recollection is that it's all comers, and they were both be HPV positive and negative.
我的記憶是,來者不拒,HPV陽性和陰性。
But we can follow up with you on that specific criterion.
但我們可以根據該特定標準跟進您。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
[Maybe], anything you want to add, or shall we follow up later on?
[也許],你有什麼想補充的,或者我們稍後會跟進嗎?
Okay.
好的。
Thanks very much, Sean.
非常感謝,肖恩。
Richard Parkes, Deutsche Bank.
理查德·帕克斯,德意志銀行。
Richard Parkes - Analyst
Richard Parkes - Analyst
Thanks for taking my questions.
感謝您回答我的問題。
Just got a couple.
剛入手一對。
Pascal, your statement in the release seems to focus a little bit more clearly on cost savings and cash generation than maybe it has in the past.
帕斯卡,你在新聞稿中的聲明似乎比過去更明確地關注成本節約和現金生成。
Maybe it's just my perception.
也許這只是我的看法。
But you've given us a bit of a steer on what to expect in terms of R&D costs for 2016.
但您已經為我們提供了一些關於 2016 年研發成本預期的指導。
Maybe, in terms of SG&A, you could give us some kind of where the pushes and pulls there that will be -- might drive SG&A costs in 2016; what we can think about there.
也許,就 SG&A 而言,您可以給我們一些推動和拉動的地方——可能會推動 2016 年的 SG&A 成本;我們可以在那裡思考什麼。
The second one is just on PD-L1, durvalumab, and the approvability though via the accelerated pathway with the FDA, which you said you think is now a lower probability.
第二個只是關於 PD-L1、durvalumab 和通過與 FDA 的加速途徑獲得批准,你說你認為現在可能性較低。
I just wondered if you could talk around the drivers there, and in terms how quickly you can get that package together.
我只是想知道你是否可以和那裡的司機談談,以及你能多快把包裹放在一起。
And maybe, do you think the FDA would still be willing to approve a PD-L1 therapy if there was a PD-1 targeting therapy with a full approval?
也許,如果有完全批准的 PD-1 靶向療法,您認為 FDA 是否仍願意批准 PD-L1 療法?
Thanks.
謝謝。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Richard, so, the cost question first; and maybe, Marc, jump in if you want to add anything.
理查德,首先是成本問題;馬克,如果您想添加任何內容,也許可以加入。
For 2016, you know we can't be very specific until we give you guidance for 2016.
對於 2016 年,您知道在我們為您提供 2016 年的指導之前我們不能非常具體。
As usual, we do that at the beginning of the year, so we'll do that next year, early next year.
像往常一樣,我們在年初這樣做,所以我們將在明年,明年初這樣做。
But what we've said so far is that we will continue to support our pipeline; but, having said that, R&D budget is expected to be broadly in line next year to what it is this year.
但到目前為止我們所說的是我們將繼續支持我們的管道;但是,話雖如此,明年的研發預算預計將與今年大致持平。
What that means is because their research engine is very productive there will be more products for us to partner, and so more externalization opportunities, next year as we continue focusing on our core TAs, and partner anything that is outside of those.
這意味著因為他們的研究引擎非常高效,明年我們將繼續專注於我們的核心 TA,並與那些之外的任何東西合作,我們將有更多的產品供我們合作,因此會有更多的外部化機會。
As far as SG&A, I can't say more than what we've said before, which is that SG&A will decline in absolute value, and as a percentage of revenue, next year.
至於 SG&A,我只能說我們之前說過的,即明年 SG&A 的絕對值和占收入的百分比將下降。
That's our expectation.
這是我們的期望。
And we'll deliver our core EPS goal for next year of SG&A cost management growth of our core platforms, and also externalization revenue.
我們將為明年核心平台的 SG&A 成本管理增長以及外部化收入實現我們的核心 EPS 目標。
That's really the -- those are the levers for us to achieve our EPS.
這真的是 - 這些是我們實現 EPS 的槓桿。
Marc, I don't know if you --
馬克,我不知道你是否——
Marc Dunoyer - CFO
Marc Dunoyer - CFO
No.
不。
Just to emphasize that we will continue our effort in 2016.
只是強調我們將在 2016 年繼續努力。
The effort we have showed the progress on in 2015, we will continue the effort for SG&A in to next year.
我們在 2015 年取得了進展,我們將在 SG&A 方面繼續努力到明年。
So, nothing changes.
所以,什麼都沒有改變。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
I think it's really important to really say something, maybe here, that maybe we haven't really talked about as much as we should.
我認為真正說點什麼真的很重要,也許在這裡,也許我們沒有真正談論我們應該談論的那麼多。
But we have been working very hard on productivity improvement over the last two years, and for next year we'll do even more of that.
但在過去兩年裡,我們一直在努力提高生產力,明年我們會做更多的事情。
These productivity improvements have driven a lot of savings, and those savings have been reinvested.
這些生產力的提高帶來了大量的節省,而這些節省又被重新投資。
So, essentially, if R&D is growing it's not because we're not improving productivity.
所以,從本質上講,如果研發在增長,那並不是因為我們沒有提高生產力。
We are tremendously improving productivity, but we reinvest all our savings in to more projects.
我們正在極大地提高生產力,但我們將所有儲蓄重新投資於更多項目。
If you look at the volume of projects, it's grown enormously.
如果你看一下項目的數量,就會發現它的增長非常快。
We have reduced many, many cost, and in many areas of the Company.
我們在公司的許多領域降低了很多很多成本。
So we -- and the same in SG&A.
所以我們——在 SG&A 中也是如此。
With durva, Sean, maybe you want to cover this one.
對於 durva,肖恩,也許你想報導這個。
But just to remind everybody, the accelerated approval, as you know, I'm sure, is only valid until someone else, another product, has received full approval in the indication you are targeting.
但我想提醒大家,加速批准,正如你所知,我敢肯定,只有在其他人、另一種產品在你的目標適應症中獲得完全批准後才有效。
So when a full approval has been achieved, you need to demonstrate that there is a [net] need and you new address it with your product.
因此,當獲得完全批准後,您需要證明存在 [淨] 需求,並用您的產品重新解決它。
It's not -- in that instance, we are not delayed against our own plan.
不是——在那種情況下,我們不會因為我們自己的計劃而被推遲。
It's actually other [compounds] of the class have been able to file earlier than expected because many of them had earlier readout of their study, and the FDA has been reviewing their submissions extremely quickly.
實際上,該類別的其他 [化合物] 能夠比預期更早提交申請,因為他們中的許多人更早地讀出了他們的研究,而且 FDA 一直在非常迅速地審查他們提交的文件。
Time lines have changed not because we are slower than we planned, but because the competing agents are moving much faster.
時間線發生變化不是因為我們比計劃慢,而是因為競爭代理人的行動速度快得多。
There are still opportunities left for us, and we're exploring those, but the project has dropped a bit.
我們仍然有機會,我們正在探索這些機會,但該項目有所下降。
Sean, do you want to add more?
肖恩,你想添加更多嗎?
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Thank you, Pascal.
謝謝你,帕斯卡。
I'll take a minute for this.
我會花一點時間。
I want to do one -- clean up really quickly and get back to Nicolas' question about HPV in KESTREL.
我想做一個——快速清理並回到 Nicolas 關於 KESTREL 中 HPV 的問題。
That is all comers with regards to HPV; there is no exclusion of HPV positive patients, or selection for HPV positive patients.
這就是關於 HPV 的所有問題;不排除 HPV 陽性患者,或選擇 HPV 陽性患者。
Now, yes, back to ATLANTIC.
現在,是的,回到大西洋。
I think -- and accelerated approval.
我認為 - 並加速批准。
This is indeed not a delay.
這確實不是拖延。
We expect the data from ATLANTIC in third line PD-L1 positive non-small cell lung cancer patients in by end of year, this year.
我們預計 ATLANTIC 在三線 PD-L1陽性非小細胞肺癌患者中的數據將於今年年底公佈。
I guess the question is, is there an opportunity?
我想問題是,有機會嗎?
I think if we look at the data, we look at the line of therapy, we look at the difference in the target, if the data is compelling it's certainly the kind of thing that we can approach the FDA with.
我認為,如果我們查看數據,查看治療線,查看目標的差異,如果數據令人信服,那肯定是我們可以與 FDA 聯繫的事情。
I just, as Pascal said, when we look at how crowded the field has become, and quickly so, we do believe the probability of success for that approach may be less than it was a while ago.
我只是,正如帕斯卡所說,當我們看到這個領域變得多麼擁擠,而且如此之快時,我們確實相信這種方法成功的可能性可能比前一段時間要低。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
I just want to remind everybody, by the way, I should have said it earlier, is that our long-range plan of last year was based on our best-case scenario -- base case for the IO platform.
我只想提醒大家,順便說一下,我應該早點說,我們去年的長期計劃是基於我們最好的情況——IO 平台的基本情況。
And that relied on -- that was based on a full approval of the [mono-substance], not the accelerated approval.
這取決於——那是基於對[單一物質]的完全批准,而不是加速批准。
The accelerated approval we always pursued as an upside to our base plan and our [peer] of last year.
我們一直追求的加速批准是對我們的基本計劃和我們去年的[同行]的一個好處。
From that viewpoint, we continue building our LRP with the full approval, as opposed to the earlier accelerated approval from mono-substance.
從這個角度來看,我們繼續在完全批准的情況下構建我們的 LRP,而不是早些時候從單一物質加速批准。
That's maybe a point to remember.
這也許是需要記住的一點。
And the second is you can go back to our first presentation to investors early 2013: our strategy has always been combination.
第二個是你可以回到我們在 2013 年初對投資者的第一次介紹:我們的戰略一直是組合。
And in that area we are certainly leading.
在那個領域,我們當然處於領先地位。
We believe we are leading.
我們相信我們處於領先地位。
And we have early data, admittedly early data, but very encouraging data, which, again, we invite you to look at tomorrow.
我們有早期數據,誠然是早期數據,但非常令人鼓舞的數據,我們再次邀請您明天查看這些數據。
Moving to Sachin's question, online question, it's again for you, Sean, AZD9291 regulatory discussions, are you still hopeful of approval ahead of PDUFA?
轉到 Sachin 的問題,在線問題,Sean,AZD9291 監管討論又是你的問題,你是否仍然希望在 PDUFA 之前獲得批准?
And also, if you could give Sachin, and everybody, an update on whether the recent safety update impacts our view on commercial partnering with PD-L1 combo?
而且,如果你可以向 Sachin 和每個人提供最新信息,說明最近的安全更新是否會影響我們對 PD-L1 組合商業合作的看法?
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Let me go with the AZD9291.
讓我使用 AZD9291。
Am I hopeful of approval?
我有希望獲得批准嗎?
I am always hopeful.
我總是充滿希望。
You have to be hopeful in the drug development business.
你必須對藥物開發業務抱有希望。
Our PDUFA date is in February, but there is a possibility that FDA will act on the molecule before the PDUFA date.
我們的 PDUFA 日期是二月,但 FDA 有可能在 PDUFA 日期之前對該分子採取行動。
And I think I mentioned that in reviewing the slides.
我想我在查看幻燈片時提到過這一點。
The other thing that I did mention with regard to CAURAL and TATTON is the partial hold from those trials does not impact the AZD9291 filing.
我提到的關於 CAURAL 和 TATTON 的另一件事是,這些試驗的部分擱置不會影響 AZD9291 的申請。
And then, the recent updates on safety, I'm guessing that you mean the PD-L1/9291 combo, and in terms of a commercial partner.
然後,關於安全性的最新更新,我猜你指的是 PD-L1/9291 組合,以及商業合作夥伴。
We really think that, that ILD signal is confined to that particular combination of agents, and really doesn't affect our ability to combine PD-L1 with other agents.
我們真的認為,ILD 信號僅限於特定的藥物組合,並且真的不會影響我們將 PD-L1 與其他藥物結合的能力。
What we're seeing was an increase in the frequency of ILD and not the severity, as such.
我們看到的是 ILD 頻率的增加,而不是嚴重程度的增加。
I think what we need to do is have a management plan that allows us to collect more data on that combination in lung cancer patients, and understand better to what extent is this manageable, and to what extent can we see if there really is activity.
我認為我們需要做的是製定一個管理計劃,使我們能夠收集更多關於肺癌患者這種組合的數據,並更好地了解這種組合在多大程度上是可管理的,以及我們在多大程度上可以看到是否真的有活動。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Maybe one thing, too, maybe that I could add actually, Sean, here is that the population of patients who received this combination was -- a great majority were Asian patients.
也許還有一件事,也許我可以補充一點,肖恩,這是接受這種組合的患者群體——絕大多數是亞洲患者。
So we need more data, as Sean said, just to understand.
所以我們需要更多的數據,正如肖恩所說,只是為了理解。
One of the things we need to understand is that issue limited to Asian patients; is it a border issue?
我們需要了解的一件事是,該問題僅限於亞洲患者;是邊界問題嗎?
And today, basically, the patients we were -- that were enrolled were mostly Asian patients.
今天,基本上,我們登記的患者大多是亞洲患者。
So, but we clearly need more data and more time.
所以,但我們顯然需要更多數據和更多時間。
Simon Baker, Exane.
西蒙貝克,Exane。
Simon Baker - Analyst
Simon Baker - Analyst
Thanks very much for taking my question.
非常感謝您提出我的問題。
I've also got two.
我也有兩個。
Firstly, on Nexium, yet again this quarter we've seen a slightly slower erosion rate in the US than expected.
首先,在 Nexium 上,本季度我們再次看到美國的侵蝕率略低於預期。
I was wondering, your thoughts as to why that's been the case.
我想知道你對為什麼會這樣的想法。
Is this a question of the attractive levels of rebate that you're already offering, meaning that the price differential between you, and even multi-sourced generics, is not as high as perhaps we thought?
這是關於你們已經提供的有吸引力的回扣水平的問題嗎,這意味著你們之間的價格差異,甚至是多源仿製藥,並不像我們想像的那麼高?
And I was wondering what that meant for the Crestor erosion next year.
我想知道這對明年的 Crestor 侵蝕意味著什麼。
If I look at the discounts that -- the maximum discount, if you like, using the VA as a proxy for Nexium, and then look at Crestor, the discounts from Crestor are even higher than the fairly significant discounts on the Nexium.
如果我看一下折扣——最大折扣,如果你願意的話,使用 VA 作為 Nexium 的代理,然後看看 Crestor,Crestor 的折扣甚至比 Nexium 上相當大的折扣還要高。
So any thoughts in how we should think about the Crestor erosion in light of the Nexium experience would be great.
因此,根據 Nexium 的經驗,我們應該如何考慮 Crestor 侵蝕的任何想法都會很棒。
And then a quick question for Sean.
然後是 Sean 的快速問題。
Just now that you've decided on the human over the murine OX40, I wonder if you can just give us an expected timeline for development there?
剛才你已經決定了人類而不是鼠類 OX40,我想知道你是否可以給我們一個預期的開發時間表?
Thanks so much.
非常感謝。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Simon.
謝謝,西蒙。
We have Paul Hudson, our Head of North America.
我們有北美負責人 Paul Hudson。
He was smiling when you are talking about Nexium because he felt probably you're telling him he is doing a good job.
當你談論 Nexium 時,他微笑著,因為他覺得你可能是在告訴他他做得很好。
But then he stopped smiling when you talked about Crestor, because we are in budget mode.
但是當你談到 Crestor 時他停止了微笑,因為我們處於預算模式。
So, maybe he thought we might expect more from him, as a result of your intervention.
因此,也許他認為由於您的干預,我們可能對他有更多期望。
Should I actually -- Luke, ask Luke to cover both of those questions?
我真的應該-- Luke,讓Luke 回答這兩個問題嗎?
Luke Miels - EVP, GPPS, Global Medical Affairs, and Corporate Affairs
Luke Miels - EVP, GPPS, Global Medical Affairs, and Corporate Affairs
Yes, sure.
是的,當然。
Simon, naturally, we know when these events are going to occur, so we have some time to prepare.
西蒙,當然,我們知道這些事件什麼時候會發生,所以我們有一些時間來準備。
And the US team did do a very good job defending Nexium, and we've kept actually comfortably more than half of the volume.
美國隊在捍衛 Nexium 方面做得非常好,我們實際上輕鬆地保持了一半以上的交易量。
But we are entering a multi-source period, of course.
但當然,我們正在進入一個多源時期。
So the relative stability that we've seen so far, I certainly wouldn't expect that, that would continue, because there's going to be more competition between these parties.
因此,到目前為止我們所看到的相對穩定性,我當然不會期望這種情況會持續下去,因為這些各方之間將會有更多的競爭。
For Crestor, our current assumption is it's a more competitive dynamic.
對於 Crestor,我們目前的假設是它更具競爭力。
The key thing to remember, of course, is that we expect these first entrant on May 2, and we do expect a more rapid erosion.
當然,要記住的關鍵是我們預計 5 月 2 日會有這些第一批進入者,我們確實預計會有更快的侵蝕。
However, between then, of course, we're continuing to grow Crestor and take share.
然而,在此期間,當然,我們將繼續發展 Crestor 並分享。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Really, remember, the Crestor environment is going to be very different with many different products, and a much more rapid erosion of price and market share for Crestor next year.
真的,請記住,Crestor 的環境將因許多不同的產品而大不相同,明年 Crestor 的價格和市場份額將更加迅速地受到侵蝕。
Having said that, I think the US team has done a tremendous job with Nexium this year.
話雖如此,我認為美國團隊今年在 Nexium 方面做得非常出色。
Mark Purcell, Barclays.
馬克·珀塞爾,巴克萊銀行。
Mark Purcell - Analyst
Mark Purcell - Analyst
I think there was a question still on OX40, but for me there are two.
我認為 OX40 仍然存在問題,但對我來說有兩個問題。
The first is on AZD9291.
第一個是 AZD9291。
I hoped you could help us understand the opportunity initially in second line, and then in the first line setting?
我希望你能幫助我們了解機會最初在二線,然後在一線設置?
And then, also, there's some emerging data that the [upfront] use of EGFR inhibitors reduces the effectiveness of PD1 and PD-L1s further down the line.
然後,還有一些新出現的數據表明,[前期] 使用 EGFR 抑製劑會進一步降低 PD1 和 PD-L1 的有效性。
And given that you included -- there a number of trials recruiting PD-L1 and PD1s first line in patients with EGFR mutations, you can see how quickly in the second line this class of agents has been taken up and has put pressure on other classes.
考慮到你包括了 - 有許多試驗在 EGFR 突變患者中招募 PD-L1 和 PD1 一線患者,你可以看到在二線中這類藥物被採用的速度有多快並對其他類別施加壓力.
I just wondered, putting all this together, whether you can help us understand the medium- and long-term opportunity for AZD9291, and the class?
我只是想知道,將所有這些放在一起,您是否可以幫助我們了解 AZD9291 和類別的中長期機會?
The second question is on lesinurad for gout.
第二個問題是關於痛風的 lesinurad。
I wondered if you'd just comment on the commercial opportunity and the launch readiness, ahead of the PDUFA from the FDA on December 29.
我想知道您是否會在 FDA 於 12 月 29 日發布 PDUFA 之前就商業機會和上市準備發表評論。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Apologies to Simon about OX40.
關於 OX40 向西蒙道歉。
Sean, you can cover OX40 and then 9291.
肖恩,你可以覆蓋 OX40,然後覆蓋 9291。
Let me just quickly give a -- make a comment on lesinurad, so we can deal with this one.
讓我快速給出一個——對 lesinurad 發表評論,這樣我們就可以處理這個問題。
I think we wait to see whether we get approval to start with, and also to look what -- to look for what the approval looks like, and then we'll make a decision as far as lesinurad.
我想我們會等著看我們是否獲得批准,然後再看看 - 看看批准的樣子,然後我們將就 lesinurad 做出決定。
We're very encouraged with that we've seen so far, in particular, the advisory committee.
到目前為止,我們對所看到的情況感到非常鼓舞,尤其是諮詢委員會。
But we really would like to wait a bit longer, before making any comment on lesinurad.
但在對 lesinurad 發表任何評論之前,我們真的想再等一會兒。
Certainly, one of the options for us for the gout franchise is to potentially partner that.
當然,我們對痛風特許經營權的選擇之一是可能成為合作夥伴。
So we have to wait a bit to decide whether we do it ourselves, launch it, when, and -- or whether we partner.
因此,我們必須稍等片刻才能決定我們是否自己做、啟動它、何時啟動它,以及——或者我們是否合作。
Sean, you want to cover the two?
肖恩,你想掩蓋這兩個人嗎?
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Sean Bohen - EVP, Global Medicines Development & Chief Medical Officer
Yes, I'm sorry.
是的,對不起。
First of all, again, apologies on the OX40.
首先,再次對 OX40 表示歉意。
But let me go ahead and answer that with regard to the human molecule.
但是讓我繼續回答關於人類分子的問題。
It's -- that molecule's in Phase I. It's actually in two Phase I trials.
它是 - 該分子處於第一階段。它實際上處於兩個第一階段試驗中。
One is a single agent; and then the other is, again, in combination with durvalumab.
一個是單一代理;然後另一個再次與 durvalumab 結合使用。
Obviously, you start out those trials with those escalation to establish safety, and there are plans to expand in patients once we've established a dose, as well.
顯然,你開始這些試驗時會增加劑量以建立安全性,並且一旦我們確定了劑量,也有計劃在患者中擴大。
Both of those trials are ongoing, they're running.
這兩項試驗都在進行中,它們正在運行。
We expect top-line results in 2017 in both cases.
我們預計這兩種情況都將在 2017 年取得頂級業績。
I think that's really all we have on those.
我認為這就是我們所擁有的一切。
Back to 9291, there were a couple of questions in there.
回到 9291,裡面有幾個問題。
One was in the lines of therapy.
一個是在治療線。
And I think it is true that, particularly in patients with a mutation, the drug is probably likely to be active in many different lines of therapy.
我認為這是真的,特別是對於有突變的患者,這種藥物可能在許多不同的治療線中都有活性。
So the question would be where is it best used?
所以問題是它最好用在哪裡?
And I think that that's a question that we are studying separately, is the 9291, with regard to non-mutants.
我認為這是一個我們正在單獨研究的問題,即 9291,關於非突變體。
Again, we have a bunch of trials, the AURA trial series.
同樣,我們有一系列試驗,即 AURA 試驗系列。
I think that those are being shared with you, and you might want to take a look at that trial list to see where we're studying it.
我認為這些正在與您分享,您可能想查看該試用列表以了解我們正在研究它的位置。
The other question you asked was about EGFR mutant.
你問的另一個問題是關於 EGFR 突變體的。
There were two things in there: one was a class of -- was using EGFR inhibitors and then PD-L1 inhibitors, or PD1 subsequently.
那裡有兩件事:一個是一類——使用 EGFR 抑製劑,然後使用 PD-L1 抑製劑,或隨後使用 PD1。
One of the things that's been noticed is that if you're EGFR mutant it looks like you're less likely to respond to the single agent, anti-PD1 or anti-PD-L1.
已經註意到的一件事是,如果您是 EGFR 突變體,那麼您似乎不太可能對單一藥物、抗 PD1 或抗 PD-L1 產生反應。
I think there is a confounded situation there, which is people who have received and stayed on anti-EGFR compounds for some time, is that a selection for another attribute which makes you resist to immune-oncology?
我認為那裡存在一個令人困惑的情況,即接受抗 EGFR 化合物並堅持使用一段時間的人,這是對另一種讓你抵抗免疫腫瘤學的屬性的選擇嗎?
Or is there truly resistance, having being previously treated?
或者是否存在真正的抵抗力,之前接受過治療?
I don't think you can sort those two things out based on the data we have right now.
我不認為你可以根據我們現在擁有的數據來解決這兩件事。
I think, Mondher, do you want to talk about the lines of therapy question?
我想,Mondher,你想談談治療線問題嗎?
Mondher Mahjoubi - SVP, Global Product Strategy, Oncology
Mondher Mahjoubi - SVP, Global Product Strategy, Oncology
Yes, thank you, Sean.
是的,謝謝你,肖恩。
I completely agree with you.
我完全同意你的觀點。
Just to add three points.
只是補充三點。
First of all, in second line, you know that almost 60% of the patient who progress on first line TKI EGFR inhibitor are progressing through the [T79] and zero mutation.
首先,在二線,你知道幾乎 60% 在一線 TKI EGFR 抑製劑上取得進展的患者正在通過 [T79] 和零突變取得進展。
So, clearly, the second line opportunity is an important one.
所以,很明顯,二線機會是一個重要的機會。
But we are not stopping there.
但我們並沒有就此止步。
We are, of course, exploring the benefit of this molecule in first line.
當然,我們正在一線探索這種分子的好處。
You may remember the data we presented at WCLC in Denver with a significant, of course, it's a single-arm Phase II trial for now, but a 75% response.
您可能還記得我們在丹佛的 WCLC 上展示的數據,當然,它目前是單臂 II 期試驗,但有 75% 的響應。
And, more important, we did a landscape analysis with a PFS at 12 months, which is 72%.
而且,更重要的是,我們在 12 個月時使用 PFS 進行了景觀分析,這是 72%。
As a matter of reference, first line TKI EGFR inhibitors medium PFS is 50%.
作為參考,一線 TKI EGFR 抑製劑中等 PFS 為 50%。
So, clearly there is a signal, and there is a much better tolerability, of course, of 9291 compared to first line TKI.
所以,顯然有一個信號,當然,與一線 TKI 相比,9291 的耐受性要好得多。
So there is an opportunity in the first line, and we are doing the AURA trial, comparing AZD9291 to either IRESSA or [SAVOR] in order to demonstrate a significant PFS benefit.
因此,第一線有機會,我們正在進行 AURA 試驗,將 AZD9291 與 IRESSA 或 [SAVOR] 進行比較,以證明顯著的 PFS 益處。
And finally, we are not stopping in first line in [advanced] disease.
最後,我們不會停在[晚期]疾病的一線。
We are developing 9291 in adjuvant.
我們正在開發 9291 的佐劑。
And, as you may know, we have our first adjuvant trial active, and, hopefully, recruiting soon; and that, of course, is of paramount, because we are there targeting disease-free survivor benefit and cure.
而且,正如您所知,我們的第一個輔助試驗正在進行中,希望能盡快招募;這當然是最重要的,因為我們的目標是無病倖存者福利和治愈。
So there is, clearly, a potential, and opportunity, to maximize the value of 9291.
因此,顯然存在最大化 9291 價值的潛力和機會。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Thanks, Mondher, and Sean.
謝謝,Mondher 和肖恩。
We'll take the last question.
我們將回答最後一個問題。
Jo Walton.
喬沃爾頓。
Jo Walton - Analyst
Jo Walton - Analyst
I'm sorry, it was a clarification; one clarification, one question.
對不起,這是一個澄清;一個澄清,一個問題。
Did you say that there would a delay to the [Faxodapper] filing outside of US?
您是否說過 [Faxodapper] 在美國境外提交申請會有所延遲?
The line clicked off and I couldn't hear the answer to that.
線路斷開,我聽不到答案。
Secondly, could you just tell us again, and I may have missed it, I think you said that you were already addressing 70% of the addressable population for Lynparza in the US.
其次,你能不能再告訴我們一次,我可能沒注意到,我想你說過你已經解決了美國 70% 的 Lynparza 可尋址人口。
Could you just go through, again, what proportion of Lynparza eligible patients are already being reached in the US?
你能再說一遍,在美國已經達到了多少符合 Lynparza 條件的患者的比例嗎?
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Yes, thanks Jo.
是的,謝謝喬。
The first one, for clarity, we are proceeding outside the US as per the plan.
第一個,為清楚起見,我們正在按照計劃在美國境外進行。
There is no -- we didn't refer to any delay, any issue outside the US.
沒有 - 我們沒有提到任何延遲,美國以外的任何問題。
We are fully on track.
我們完全走上正軌。
As far as Lynparza, I'll ask Luke.
至於 Lynparza,我會問 Luke。
But remember that the indication in the US is more restrictive than the indication in Europe.
但請記住,美國的指示比歐洲的指示更具限制性。
As you'll probably remember, we had a [pulling up] with the indication we requested upfront in the US.
正如您可能還記得的那樣,我們有一個 [拉起來] 我們在美國預先要求的指示。
We had a negative advisory committee, if you remember, mid-2014, and then we re-filed with a more restricted indication.
如果您還記得的話,我們在 2014 年年中有一個負面的諮詢委員會,然後我們重新提交了一個更受限制的指示。
So, Luke, go ahead.
所以,盧克,繼續吧。
Luke Miels - EVP, GPPS, Global Medical Affairs, and Corporate Affairs
Luke Miels - EVP, GPPS, Global Medical Affairs, and Corporate Affairs
Yes.
是的。
And I'd also add, you've got the [G-BACA] dimension there, as well.
我還要補充一點,你也有 [G-BACA] 維度。
It's 75%, not 70%.
是 75%,不是 70%。
And I think the uptake has been very positive.
我認為吸收是非常積極的。
And also, people are staying on the product slightly longer than we would expect, which, again, is encouraging in terms of the tolerability.
而且,人們使用該產品的時間比我們預期的要長一些,這在耐受性方面再次令人鼓舞。
And the testing rate continues to trend upwards in all markets.
所有市場的檢測率都呈上升趨勢。
And the other thing to remember when you look at the sale is that we have a sequential launch process across the globe, so it should provide more color as we look into 2016.
當您查看銷售時要記住的另一件事是我們在全球範圍內有一個連續的發布過程,因此它應該會在我們展望 2016 年時提供更多顏色。
And then finally, we have quite a dense program with Lynparza, and we'll get more color around that next year.
最後,我們有一個非常密集的 Lynparza 計劃,明年我們將獲得更多的顏色。
Jo Walton - Analyst
Jo Walton - Analyst
Thank you.
謝謝你。
Pascal Soriot - Executive Director, CEO
Pascal Soriot - Executive Director, CEO
Very good.
非常好。
So, let me thank everybody for your active participation.
所以,讓我感謝大家的積極參與。
I'd like to just, maybe, close by reminding you that we believe we had a good, solid Q3.
也許,我想提醒你,我們相信我們有一個良好、穩固的第三季度。
And our year-to-date results allow us to upgrade our guidance.
我們年初至今的結果使我們能夠升級我們的指導。
We'll continue to manage our SAG&A costs, and we'll deliver on our commitments to you.
我們將繼續管理我們的 SAG&A 成本,並兌現我們對您的承諾。
We continue doing what we told you we would do: progress our pipeline, invest in science.
我們繼續做我們告訴過你我們會做的事情:推進我們的管道,投資於科學。
But we also look for productivity improvements, and certainly manage our costs, to deliver our EPS goals this year and next year; and, more importantly, deliver our long-term sales goals 2017 and 2023.
但我們也尋求提高生產力,當然還要管理我們的成本,以實現我們今年和明年的 EPS 目標;更重要的是,實現我們 2017 年和 2023 年的長期銷售目標。
Thank you for your attention.
感謝您的關注。