AstraZeneca PLC (AZN) 2016 Q1 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • - CEO

    - CEO

  • Hello, everyone, I'm Pascal Soriot, CEO of AstraZeneca.

    大家好,我是阿斯利康公司的 CEO Pascal Soriot。

  • Welcome to the Q1 2016 results conference call for investors and analysts.

    歡迎參加面向投資者和分析師的 2016 年第一季度業績電話會議。

  • The presentation is posted online for you to download and there is also an audio player.

    演示文稿發佈在網上供您下載,還有一個音頻播放器。

  • I'm joined today by Luke Miels, Executive Vice President for Global Production for Product and Portfolio Strategy, Global Medical Affairs and Corporate Affairs; Marc Dunoyer, our CFO; and Sean Bohen, our CMO.

    今天,負責產品和投資組合戰略、全球醫療事務和公司事務的全球生產執行副總裁 Luke Miels 加入了我的行列;我們的首席財務官 Marc Dunoyer;和我們的首席營銷官 Sean Bohen。

  • We plan to spend 20 to 25 minutes on the presentation and then leave ample time for Q&A.

    我們計劃花 20 到 25 分鐘進行演示,然後留出充足的時間進行問答。

  • In total we have about one hour together.

    我們總共有大約一個小時的時間。

  • So please turn to Slide 2, where you see our forward-looking statements.

    所以請轉到幻燈片 2,您可以在其中看到我們的前瞻性陳述。

  • Moving to Slide 3, you will see there the agenda.

    轉到幻燈片 3,您會看到議程。

  • The plan for today for me is to provide a short overview, and then I'll hand over to Luke for an update on our growth platforms and the ongoing launches of new medicines.

    我今天的計劃是提供一個簡短的概述,然後我將交給 Luke,介紹我們的增長平台的最新情況和正在推出的新藥。

  • As usual, Marc cover the financials and our guidance, and Sean will provide a pipeline and useful update, and I will end up with concluding remarks before we take your questions.

    像往常一樣,Marc 負責財務和我們的指導,Sean 將提供管道和有用的更新,在我們回答您的問題之前,我將以結束語結尾。

  • Moving to Slide 4, Q1 2016 was a good start to the year for AstraZeneca, and we met expectations.

    轉到幻燈片 4,2016 年第一季度對阿斯利康來說是一個良好的開端,我們達到了預期。

  • We delivered 5% growth in our total revenue, 6% growth in our growth platforms.

    我們的總收入增長了 5%,增長平台增長了 6%。

  • Our focus on cost discipline continued as we reduced core SG&A costs by 6%.

    隨著我們將核心 SG&A 成本降低 6%,我們繼續關注成本紀律。

  • Within R&D costs, we showed slowdown in growth despite taken on board R&D costs related to ZS Pharma and Acerta.

    在研發成本中,儘管計入了與 ZS Pharma 和 Acerta 相關的研發成本,但我們仍顯示增長放緩。

  • We received four regulatory approvals and four regulatory designations, which underlined the continued progress of the pipeline.

    我們獲得了四項監管批准和四項監管指定,這突顯了管道的持續進展。

  • Now taking a step back and looking at how we advance our strategy.

    現在退後一步,看看我們如何推進我們的戰略。

  • AstraZeneca continues to make significant progress toward the total revenue target that we communicated earlier for 2023.

    阿斯利康(AstraZeneca)繼續在實現我們早些時候傳達的 2023 年總收入目標方面取得重大進展。

  • The company has increased pipeline productivity.

    該公司提高了管道生產率。

  • We've built our therapy area leadership.

    我們已經建立了治療領域的領導地位。

  • We've developed our growth platforms, and clearly we've transformed our culture as well.

    我們開發了我們的增長平台,顯然我們也改變了我們的文化。

  • The shape of the business is evolving rapidly now, with a growing number of specialty care medicines in (inaudible) oncology.

    隨著越來越多的(聽不清)腫瘤學專業護理藥物的出現,業務形態正在迅速發展。

  • In line with this strategy designed to deliver benefits to patients and value for shareholders, we today announced further focus on our main therapy areas to drive greater productivity across the organization.

    根據這一旨在為患者帶來利益和為股東創造價值的戰略,我們今天宣布進一步關注我們的主要治療領域,以提高整個組織的生產力。

  • The growth of our pipeline is such that we have to further prioritize and further sharpen our focus, and we have to allocate additional investments to oncology.

    我們管道的增長使得我們必須進一步確定優先次序並進一步加強我們的重點,我們必須為腫瘤學分配額外的投資。

  • Alongside this, we'll continue to work with others in the opportunity-led parts of the portfolio, and accelerate the partnering of areas such as infection, neuroscience, and inflammatory diseases outside of respiratory.

    除此之外,我們將繼續在投資組合中以機會為導向的部分與其他人合作,並加快在感染、神經科學和呼吸系統以外的炎症性疾病等領域的合作。

  • So this focus will also streamline our operations, primarily in commercial and manufacturing, and this together with the drive for greater efficiency will deliver a material decline in our core SG&A costs in 2016 and 2017, as we previously guided we would be targeting.

    因此,這一重點還將簡化我們的運營,主要是在商業和製造領域,這與提高效率的動力一起將使我們在 2016 年和 2017 年的核心 SG&A 成本大幅下降,正如我們之前指導的目標。

  • These changes will increase our operational effectiveness and by the end of 2017 they are expected to generate net annualized benefits of about $1.1 billion, that will be reflected primarily in our core SG&A cost.

    這些變化將提高我們的運營效率,到 2017 年底,它們預計將產生約 11 億美元的年淨收益,這將主要反映在我們的核心 SG&A 成本中。

  • We expect to incur a $1.5 billion one-time restructuring charge, the majority of which will be cash.

    我們預計將產生 15 億美元的一次性重組費用,其中大部分將是現金。

  • Final estimates for program cost of the benefit and the impact will be subject to consultation.

    收益和影響的計劃成本的最終估計將以協商為準。

  • Marc will provide further details later on.

    Marc 稍後將提供更多詳細信息。

  • Turning to Slide 5, you see the 5% growth in total revenue here that was impacted by 4% hit from currency movement.

    轉到幻燈片 5,您會看到總收入增長 5%,這是受到貨幣變動 4% 的影響。

  • The growth in total revenue was primarily driven by externalization revenue from new China partnership on Plendil, a medicine for hypertension.

    總收入的增長主要是由新的中國合作夥伴 Plendil(一種治療高血壓的藥物)帶來的外部化收入推動的。

  • Our product sales grew by 1%.

    我們的產品銷售額增長了 1%。

  • The growth platform grew by 6%.

    增長平台增長了6%。

  • As I said earlier, R&D cost grew by 6%, and we intend by the end of the year to keep the cost broadly in line with last year.

    正如我之前所說,研發成本增長了 6%,我們打算在今年年底前將成本與去年大致持平。

  • In fact, the growth in R&D would have been 9% if we adjust for recent acquisitions.

    事實上,如果我們根據最近的收購進行調整,研發的增長率將達到 9%。

  • We are on track to deliver what we communicated as far as R&D cost for the year.

    就今年的研發成本而言,我們有望實現我們所傳達的信息。

  • We continue to see a good reduction on SG&A.

    我們繼續看到 SG&A 的大幅減少。

  • We're also on track to achieve our goals for SG&A cost management for the year.

    我們也有望實現今年的 SG&A 成本管理目標。

  • And the core EPS decline of 7% reflects the lower level of other operating income and increased financing cost from the recent transactions.

    核心每股收益下降 7% 反映了其他營業收入水平較低以及近期交易的融資成本增加。

  • Slide 6, this is a very exciting slide that shows that we achieved four approvals in the first quarter, and four designations.

    幻燈片 6,這是一張非常令人興奮的幻燈片,顯示我們在第一季度獲得了四項批准和四項指定。

  • So as you can see here, we are pleased with the fact that the first medicine from our acquisition of Pearl Therapeutics can soon benefit patients with the approval of Bevespi, previously known as PT003.

    因此,正如您在這裡看到的,我們很高興我們收購 Pearl Therapeutics 的第一種藥物在 Bevespi 的批准下很快就能使患者受益,之前稱為 PT003。

  • With the triple combination PT010 in Phase III, we're well-positioned to offer the benefit of the unique co-suspension technology that allows multiple medicines in the same unique device.

    憑藉處於 III 期的三重組合 PT010,我們處於有利地位,可以提供獨特的共懸浮技術的優勢,該技術允許在同一個獨特的設備中使用多種藥物。

  • Zurampic and Brilique each received approval in the EU for gout and post-MI, respectively.

    Zurampic 和 Brilique 在歐盟分別獲得了治療痛風和心肌梗死後的批准。

  • Very importantly, Tagrisso received Japanese approval in certain forms of non-small cell lung cancer, and we consider this as a true milestone.

    非常重要的是,Tagrisso 在某些形式的非小細胞肺癌中獲得了日本的批准,我們認為這是一個真正的里程碑。

  • Not only is Japan the market with most potential patients, but the timing for Japanese approval is a new record, only a few months after approval in the US and EU.

    日本不僅是擁有最多潛在患者的市場,而且日本批准的時間也創下新紀錄,僅比美國和歐盟批准幾個月。

  • It reflects the quality of the product, of course, but the commitment and the dedication of our team as well, in Japan and globally.

    它當然反映了產品的質量,但也反映了我們團隊在日本和全球的承諾和奉獻精神。

  • We look forward to publishing further data for Tagrisso as we see longer and longer progression-free survival, and also a large benefit to patients with brain metastases of [frequent sight] for disease progression in lung cancer patients.

    我們期待著發布 Tagrisso 的更多數據,因為我們看到無進展生存期越來越長,並且對於肺癌患者的疾病進展 [frequent sight] 腦轉移患者也有很大的好處。

  • On top of the four approvals, we received for regulatory designations that are detailed here on the page.

    除了這四項批准外,我們還收到了本頁詳細說明的監管指定。

  • We are excited with the external recognition of our advances in science and the patient benefit that this brings.

    我們對我們在科學方面的進步以及由此帶來的患者利益的外部認可感到興奮。

  • With this, I will hand over to Luke who will take you through the growth platform.

    有了這個,我將交給Luke,他將帶您完成成長平台。

  • - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

    - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

  • Thanks, Pascal.

    謝謝,帕斯卡。

  • Hello, everyone, so if we can just go to Slide 8.

    大家好,我們可以直接轉到幻燈片 8。

  • So, quarter one marked a good solid start to the year for the growth platforms.

    因此,第一季度標誌著增長平台今年的良好開端。

  • Our growth rate slowed in some areas versus last quarter.

    與上一季度相比,我們在某些領域的增長率有所放緩。

  • However, our performance remained in line with our long-term goals.

    然而,我們的表現仍然符合我們的長期目標。

  • Despite a challenging external environment, our performance was driven by our well-positioned geographic footprint and diverse product offering, focused within our key therapeutic areas.

    儘管外部環境充滿挑戰,但我們的業績得益於我們定位良好的地理足跡和多樣化的產品供應,專注於我們的關鍵治療領域。

  • Would you move to Slide 9, thanks.

    請轉到幻燈片 9,謝謝。

  • So if I start with respiratory this morning, we delivered 2% sales growth during the quarter, which reflected a strong performance in emerging markets, and the contribution from new products.

    因此,如果我今天早上從呼吸開始,我們在本季度實現了 2% 的銷售額增長,這反映了新興市場的強勁表現以及新產品的貢獻。

  • This was offset however by Symbicort in the US and the EU.

    然而,這在美國和歐盟被 Symbicort 抵消了。

  • Total sales of Symbicort declined 7% in the US specifically.

    Symbicort 在美國的總銷售額下降了 7%。

  • Volume growth was partly offset by pricing as result of new contracts.

    新合同的定價部分抵消了銷量增長。

  • Moving forwards we do expect pricing to stabilize over the year as these new contracts settle in.

    展望未來,我們預計隨著這些新合同的簽訂,價格將在一年內穩定下來。

  • Europe sales continue to be affected by slower in-class market growth and competitive pressures, from both branded competition and analogues.

    歐洲銷售繼續受到同類產品市場增長放緩和來自品牌競爭和類似產品的競爭壓力的影響。

  • However, despite a highly competitive market in EU, Symbicort maintained its market leadership in the class and encouragingly, Symbicort in the pMDI format was also approved for COPD in Europe.

    然而,儘管歐盟市場競爭激烈,Symbicort 仍保持其在同類產品中的市場領先地位,令人鼓舞的是,pMDI 格式的 Symbicort 也被批准用於歐洲的 COPD。

  • Emerging markets respiratory sales grew 18%, now accounting for 14% of global product sales, and Pulmicort growth was largely driven by a 24% increase in emerging markets, particularly in China which delivered a very pleasing 34% growth.

    新興市場的呼吸系統銷售額增長了 18%,目前佔全球產品銷售額的 14%,而 Pulmicort 的增長主要是由新興市場 24% 的增長推動的,尤其是中國實現了 34% 的令人欣喜的增長。

  • Pulmicort in China continues to grow from the expansion of the treatment centers, and we believe that this growth sustainable with additional initiatives in home nebulization and linked to this a change in the marketplace that should ultimately benefit Symbicort.

    Pulmicort 在中國隨著治療中心的擴張而持續增長,我們相信隨著家庭霧化方面的額外舉措,這種增長是可持續的,並且與此相關的市場變化最終將使 Symbicort 受益。

  • As for the new medicines in respiratory, Duaklir is achieving market share of 20% to 30% in our lead markets, and Eklira and Tudorza managed to grow ahead of the market, in a decreasing LAMA class.

    至於呼吸系統的新藥,Duaklir 在我們的主要市場中取得了 20% 至 30% 的市場份額,而 Eklira 和 Tudorza 在不斷下降的 LAMA 類別中成功地領先於市場。

  • In the US, Tudora was impacted by tougher access and a voluntary recall.

    在美國,Tudora 受到更嚴格的准入和自願召回的影響。

  • We remain confident about the potential of the class given that the treatment guidelines recommend the addition of a third bronchodilator to standard ICS/LABA combination treatment for patients who are not controlled.

    鑑於治療指南建議在標準 ICS / LABA 聯合治療的基礎上對不受控制的患者添加第三種支氣管擴張劑,我們仍然對該類藥物的潛力充滿信心。

  • Finally we're very happy to receive the FDA approval for Bevespi, our LAMA/LABA, using our proprietary co-suspension technology.

    最後,我們非常高興使用我們專有的共懸浮技術獲得 FDA 對我們的 LAMA/LABA Bevespi 的批准。

  • Bevespi is the first in class to be delivered in a pMDI.

    Bevespi 是同類產品中第一個在 pMDI 中交付的。

  • With this approval we are very pleased to offer a new treatment option to COPD patients, and the approval of Bevespi represents a successful milestone for our respiratory franchise, which we expect to see further evolve later this year with benralizumab and tralokinumab data, and Sean will cover this shortly.

    有了這一批准,我們很高興為 COPD 患者提供新的治療選擇,Bevespi 的批准代表了我們呼吸特許經營權的一個成功里程碑,我們預計今年晚些時候將通過貝那利珠單抗和 tralokinumab 數據進一步發展,Sean 將稍後介紹。

  • Can we just go to Slide 10, thanks.

    我們可以轉到幻燈片 10 嗎,謝謝。

  • So for Brilinta, global product sales were robust, growing by 46%.

    因此,對於 Brilinta 而言,全球產品銷售強勁,增長了 46%。

  • In the US, Brilinta gained further total market share at the expense of generic clopidogrel and one branded competitor; and if we look at new to brand prescriptions, Brillinta remained the branded market leader.

    在美國,Brilinta 以仿製藥氯吡格雷和一個品牌競爭者為代價獲得了進一步的總市場份額;如果我們看看新品牌處方,Brillinta 仍然是品牌市場的領導者。

  • And we also had some good news on guidelines out of the ACC in March.

    我們在 3 月份還收到了一些關於 ACC 準則的好消息。

  • So the updated ACC/AHA guidelines in the quarter now recommend Brilinta over clopidogrel in STEMI patients, and with the support for treatment beyond 12 months of dual antiplatelet treatment.

    因此,本季度更新的 ACC/AHA 指南現在推薦 Brilinta 優於氯吡格雷用於 STEMI 患者,並支持超過 12 個月的雙重抗血小板治療。

  • These guidelines now support the longer use of this therapy in patients beyond one year.

    這些指南現在支持在超過一年的患者中更長時間地使用這種療法。

  • While the US sales are encouraging, we do need to keep patients on the medicine longer for them to fully benefit from the treatment, and this will be a focus for us, and certainly the guidelines will support this messaging.

    雖然美國的銷售令人鼓舞,但我們確實需要讓患者更長時間地服用藥物,以便他們從治療中充分受益,這將是我們關注的重點,當然指南也將支持這一信息。

  • In the EU we had growth of 19% with approval of Brilique in the post-MI indication in February.

    在歐盟,我們在 2 月份批准了 Brilique 在 MI 後適應症中的增長 19%。

  • The launch of the 60mg dose is now underway in Germany, the Nordic countries, and the UK, and the Netherlands has already secured early reimbursement.

    德國、北歐國家和英國目前正在推出 60 毫克劑量,荷蘭已經提前獲得報銷。

  • In emerging markets it was another good quarter, with consistent growth continued, with particular strength in China, despite the fact that there is no price listing or reimbursement, and we also saw encouraging growth in Russia.

    在新興市場,這是另一個不錯的季度,持續增長,中國尤其強勁,儘管沒有價格清單或報銷,我們也看到了俄羅斯令人鼓舞的增長。

  • Please turn to Slide 11.

    請轉到幻燈片 11。

  • If we now look at diabetes, the strong performance in 2015 continued into the first quarter.

    如果我們現在來看糖尿病,2015 年的強勁表現一直持續到第一季度。

  • We had a strong performance of 23%.

    我們有 23% 的強勁表現。

  • Growth was visible across all the regions, you see this on the slide here in the middle, in what remains a very competitive market.

    所有地區的增長都是顯而易見的,你可以在中間的幻燈片上看到這一點,這個市場仍然競爭非常激烈。

  • I think we're well-positioned with our broad portfolio and exposure to all classes in the non-insulin market, and if we look at the Farxiga family, it continued lead the SGLT2 class in volume share in the EU and international markets, and also led the dynamic market share in Japan.

    我認為我們憑藉廣泛的產品組合和對非胰島素市場所有類別的敞口處於有利地位,如果我們看一下 Farxiga 系列,它繼續在歐盟和國際市場上的 SGLT2 類銷量份額中處於領先地位,並且在日本也引領了活躍的市場份額。

  • In the US, Farxiga gained share due to preferred status with one major health plan, and outgrew the SGLT class, but I think it's fair to say that competition within the class is expected to remain very intense.

    在美國,Farxiga 由於在一項主要健康計劃中的優先地位而獲得了份額,並且超過了 SGLT 類別,但我認為可以公平地說,該類別內的競爭預計將保持非常激烈。

  • For Bydureon, the growth was supported by strong class growth of around 25% overall, and the continued successful launch of the pen device helped drive product sales across the globe.

    對於 Bydureon 而言,這一增長得到了約 25% 的強勁類別增長的支持,筆式設備的持續成功推出有助於推動全球產品銷售。

  • Product sales in Europe and Japan continue to outpace the class, and while the US also benefited from market growth, competitive pressure remained.

    歐洲和日本的產品銷量繼續超過同類產品,雖然美國也受益於市場增長,但競爭壓力依然存在。

  • Next slide, thanks.

    下一張幻燈片,謝謝。

  • If we look at emerging markets in aggregate, during the quarter the overall market, emerging markets growth rate slowed.

    如果我們從整體上看新興市場,本季度整體市場,新興市場增長率放緩。

  • However, we are on track with our long-term goals.

    然而,我們正朝著我們的長期目標邁進。

  • Our established portfolio is well-positioned as the main near-term growth driver in emerging markets.

    我們既定的投資組合處於新興市場的主要近期增長驅動力的有利地位。

  • Trends of better diagnosis, improved access, and favorable patient dynamics all bode well for our established products in respiratory, diabetes, and CV medicine.

    更好的診斷、更好的訪問和有利的患者動態的趨勢都預示著我們在呼吸、糖尿病和 CV 醫學領域的成熟產品。

  • The slowdown in growth in the first quarter was mostly attributable to two factors: the macroeconomic situation in Venezuela, and a significant cut in government spending within Saudi Arabia

    一季度增速放緩主要受兩方面因素影響:委內瑞拉宏觀經濟形勢和沙特大幅削減政府開支

  • Looking at geographic performance, while growth in China slowed during the quarter, including some inventory reductions in the sales channel, we are growing faster than other multinational companies, and growing faster than the overall market.

    從地域表現來看,雖然本季度中國的增長放緩,包括銷售渠道的一些庫存減少,但我們的增長速度高於其他跨國公司,也高於整個市場的增長速度。

  • Pulmicort Respules, interestingly, is now the top medicine in China amongst the multinational company medicines, with Nexium and Crestor also in the top 15.

    有趣的是,普米可樂現在是跨國公司藥品中在中國排名第一的藥品,耐信和克瑞舒也在前 15 名之列。

  • Looking forward we expect to maintain the solid growth in China.

    展望未來,我們預計將保持在中國的穩健增長。

  • Brazil and Russia grew faster than the market at 19% and 5%, respectively, and also the Middle East and Africa and most of Latin America also grew faster than their local markets.

    巴西和俄羅斯分別以 19% 和 5% 的速度增長快於市場,中東和非洲以及拉丁美洲大部分地區的增長也快於當地市場。

  • Moving from geographic performance, just to give you a little bit of color around product sales, emerging markets growth was supported across all the main therapeutic areas.

    從地理表現來看,只是為了讓您對產品銷售有一點了解,所有主要治療領域都支持新興市場的增長。

  • So respiratory sales were up by 20%, Brilinta was up 109%, diabetes was up 65%, and finally legacy, and I emphasize legacy, oncology was up 5%.

    因此,呼吸系統銷售額增長了 20%,Brilinta 增長了 109%,糖尿病增長了 65%,最後是傳統,我強調傳統,腫瘤學增長了 5%。

  • As a reminder, and we've placed this on the slide for you, the long-term target for emerging markets is mid-to-high single-digit percentage growth in product sales, and we remain on track for this.

    提醒一下,我們已經為您將其放在幻燈片上,新興市場的長期目標是產品銷售額實現中高個位數百分比增長,我們將繼續實現這一目標。

  • Next slide, thanks.

    下一張幻燈片,謝謝。

  • Coming to Japan, in Japan product sales declined by 7%, driven by the mature portfolio which had a decline of 10%.

    來到日本,由於成熟的產品組合下降了 10%,日本的產品銷售額下降了 7%。

  • However, the growth platforms grew by 8%.

    然而,增長平台增長了8%。

  • Specifically, our off-patent oncology medicines continued to face strong generic competition, and there was also some destocking in the quarter, in advance of the biennial price cuts from the 1st of April, and these price cuts are a similar level to those in 2014, with a total impact of about 6%.

    具體而言,我們的非專利腫瘤藥物繼續面臨強大的仿製藥競爭,在 4 月 1 日開始的雙年度降價之前,本季度也有一些去庫存,這些降價幅度與 2014 年相似, 總影響約為 6%。

  • These were concentrated on the off-patent oncology and anesthesia medicines, as well as our major revenue generating medicines Crestor and also Nexium.

    這些集中在非專利腫瘤和麻醉藥物,以及我們主要的創收藥物 Crestor 和 Nexium。

  • Specifically for Nexium, the Q1 2015 comparison, just to flag it to you, was high due to restocking, because we had a recall in 2014 in Q4.

    特別是對於 Nexium,2015 年第一季度的比較,只是為了提醒您,由於補貨,我們在 2014 年第四季度進行了召回。

  • During the quarter, the key growth medicines in Japan, Symbicort, Crestor, and Nexium, all maintained leading dynamic market share positions, in a competitive market environment, and that's we've put there in the middle of the slide.

    在本季度,日本的主要增長藥物 Symbicort、Crestor 和 Nexium 在競爭激烈的市場環境中都保持了領先的動態市場份額地位,這就是我們放在幻燈片中間的位置。

  • You can see the bar charts

    你可以看到條形圖

  • In addition to our established portfolio in Japan, we're also preparing for the next wave of product launches.

    除了我們在日本的既定產品組合外,我們還在為下一波產品發布做準備。

  • And we are very excited about the recent regulatory approval for Tagrisso at the end of March, as Pascal flagged, just seven months after submission, and a few months after approvals in the US and EU.

    正如 Pascal 所標記的那樣,我們對 Tagrisso 在 3 月底獲得的監管批准感到非常興奮,這是在提交後僅七個月,以及在美國和歐盟獲得批准後的幾個月。

  • And we expect Tagrisso to benefit from our existing oncology presence and infrastructure, as we outlined at the annual results, and it represents a significant opportunity to address a high unmet need in a population which has a high prevalence of the EGFR mutation.

    我們預計 Tagrisso 將受益於我們現有的腫瘤學存在和基礎設施,正如我們在年度結果中概述的那樣,它代表了一個重要的機會來解決 EGFR 突變高發人群中未滿足的高需求。

  • Please turn to Slide 14.

    請轉到幻燈片 14。

  • So if we finish off some very exciting news.

    因此,如果我們結束一些非常令人興奮的消息。

  • So the two new oncology product launches, Lynparza continued its strong trajectory after one year of approval.

    因此,這兩款新的腫瘤產品上市後,Lynparza 在獲得批准一年後繼續保持強勁勢頭。

  • Globally an estimated 2,800 patients have now been treated with commercial supply on Lynparza.

    在全球範圍內,估計有 2,800 名患者現在接受了 Lynparza 的商業供應治療。

  • Despite the bulk of patients being fourth-line, we continue to see encouraging signs of the durability of the response for Lynparza and interestingly we estimate around 20% of the initial patients remain on the medicine.

    儘管大部分患者都在四線治療,但我們繼續看到令人鼓舞的跡象,表明 Lynparza 的反應持久,有趣的是,我們估計大約 20% 的初始患者仍在使用該藥物。

  • Lynparza is now being launched in 21 countries, with reviews ongoing in 14.

    Lynparza 目前正在 21 個國家/地區上市,14 個國家/地區正在進行審查。

  • And as can be seen from the middle part of the slide, BRCA testing rates have again increased over the past 18 months to around 60% in the US, and around half the eligible patients in the EU, which is very encouraging.

    從幻燈片的中間部分可以看出,在過去 18 個月中,美國的 BRCA 檢測率再次上升到 60% 左右,而歐盟符合條件的患者中約有一半,這非常令人鼓舞。

  • And as Sean will explain later, the extensive development program is quickly advancing, and 2016 will be an exciting year for Lynparza, and advancing also the promise and our commitment in the area of DNA damage response.

    正如 Sean 稍後將解釋的那樣,廣泛的開發計劃正在迅速推進,2016 年對 Lynparza 來說將是激動人心的一年,同時也推進了我們在 DNA 損傷反應領域的承諾和承諾。

  • Turning to Tagrisso, again we've made very good progress just over a quarter after launch.

    談到 Tagrisso,我們在發布後僅四分之一多的時間裡再次取得了非常好的進展。

  • We received approval in the EU in February, in addition to the Japan approval I mentioned earlier, with multiple submissions and reviews ongoing.

    除了我之前提到的日本批准外,我們在 2 月份還獲得了歐盟的批准,多項提交和審查正在進行中。

  • In terms of patient numbers, just to provide a little bit of context for you, we currently have nearly 2,000 patients in pre-launch access programs, and as a leading indicator T790M mutation testing rates are on the rise.

    就患者數量而言,為您提供一點背景信息,我們目前有近 2,000 名患者處於啟動前訪問計劃中,作為領先指標,T790M 突變檢測率正在上升。

  • In the US, the rate is around 40%, up from 10% before launch.

    在美國,這一比例約為 40%,高於推出前的 10%。

  • And I think this is very interesting because unlike BRCA, prior to the availability of Tagrisso, there was no utility in testing these patients, because there was no therapeutic option for them.

    我認為這很有趣,因為與 BRCA 不同,在 Tagrisso 上市之前,對這些患者進行測試沒有任何用處,因為他們沒有治療選擇。

  • On top of this we anticipate testing rates to increase further after the ctDNA diagnostic test is expected to become available in the US in the second quarter of this year.

    除此之外,我們預計在 ctDNA 診斷測試預計將於今年第二季度在美國上市後,測試率將進一步提高。

  • So in summary, reflecting on the growth driver performance in Q1, while the growth rates slowed in some areas, the resilience of the business was strong and in line with our expectations.

    因此,總而言之,反映第一季度的增長動力表現,雖然某些領域的增長率有所放緩,但業務的彈性很強,符合我們的預期。

  • I'll now hand over to Marc.

    我現在將交給馬克。

  • - CFO

    - CFO

  • Thanks, Luke and hello, everyone.

    謝謝,盧克,大家好。

  • I'm going to spend the next few minutes taking you through our performance in the first quarter and our guidance for the full year.

    在接下來的幾分鐘裡,我將帶您了解我們第一季度的業績以及我們全年的業績指引。

  • Please turn to Slide 16.

    請轉到幻燈片 16。

  • As Pascal mentioned earlier, total revenue grew by 5% at constant exchange rates.

    正如 Pascal 之前提到的,按固定匯率計算,總收入增長了 5%。

  • We continued to face currency headwinds in the quarter, which impacted total revenues by 4%.

    我們在本季度繼續面臨貨幣逆風,這對總收入造成了 4% 的影響。

  • Our growth platform again performed well and in line with our business model.

    我們的增長平台再次表現良好,符合我們的商業模式。

  • We continue to generate value through externalization.

    我們繼續通過外部化創造價值。

  • For example, [indiscernible] agreement with CMS for Plendil in China, and an agreement with ProStrakan for Moventig in Europe.

    例如,與 CMS 就 Plendil 在中國達成的 [音頻不清晰] 協議,以及在歐洲與 ProStrakan 就 Moventig 達成的協議。

  • In line with full-year guidance, core SG&A cost reduced by 6% to 35% of total revenue.

    根據全年指導,核心 SG&A 成本佔總收入的比例下降了 6% 至 35%。

  • This was a significant improvement versus quarter one 2015.

    與 2015 年第一季度相比,這是一個顯著的進步。

  • Further down the P&L, the rising financing charges reflected the dilutive effect arising from the ZS Pharma acquisition and Acerta Pharma investment.

    在損益表中,不斷上升的融資費用反映了 ZS Pharma 收購和 Acerta Pharma 投資產生的攤薄效應。

  • The 7% decline in core EPS at constant exchange rates to $0.95 was also driven by the impact of a significant year-on-year decrease in other operating income.

    按固定匯率計算,核心每股收益下降 7% 至 0.95 美元,這也是受到其他營業收入同比大幅下降的影響。

  • The adverse impact of the currency headwinds on core EPS was 5%.

    貨幣逆風對核心每股收益的不利影響為 5%。

  • Finally, as I mentioned at our last results presentation, we may well see greater fluctuation in the quarterly earning performance this year as a result of the loss of Crestor, which goes off-patent next week.

    最後,正如我在上次業績報告中提到的那樣,由於下週專利到期的 Crestor 失效,我們很可能會看到今年季度盈利表現出現更大波動。

  • So please turn to Slide 17.

    所以請轉到幻燈片 17。

  • Looking at [over in line] the P&L, product sales grew by 1% despite significant challenges, for example for Nexium.

    查看 [在線] 損益表,儘管面臨重大挑戰,例如 Nexium,產品銷售額仍增長了 1%。

  • Given a 6% rise in the cost of sales, the gross margin on product sales fell by one percentage point to 83%.

    在銷售成本上升6%的情況下,產品銷售毛利率下降1個百分點至83%。

  • The 15% increase in core R&D in the quarter included the absorption of the R&D cost from acquisition and investments.

    本季度核心研發增長 15%,包括從收購和投資中吸收的研發成本。

  • Excluding this absorption, core R&D cost would have grown by 9%, a significant slowdown.

    排除這種吸收,核心研發成本將增長 9%,顯著放緩。

  • Our core tax rate was 17% in the quarter, in line with the full-year comments I made in February, over 16% to 20% range, which will depend on the eventual geographical mix of profits.

    我們本季度的核心稅率為 17%,與我在 2 月份發表的全年評論一致,超過 16% 至 20% 的範圍,這將取決於最終的利潤地域組合。

  • Please turn to Slide 18.

    請轉到幻燈片 18。

  • Core SG&A reduction continues to be a key focus for the business.

    減少核心 SG&A 仍然是該業務的重點。

  • We made good progress in the quarter.

    我們在本季度取得了良好進展。

  • As I mentioned earlier, core SG&A cost declined by 6% in absolute value, and by over 4 percentage points relative to total revenue in quarter one 2015.

    正如我之前提到的,核心 SG&A 成本的絕對值下降了 6%,相對於 2015 年第一季度的總收入下降了 4 個百分點以上。

  • As I stated in February, core R&D cost this year, I expect it to be at a similar level to full-year 2015.

    正如我在 2 月份所說,今年的核心研發成本,我預計它與 2015 年全年處於相似水平。

  • You can clearly see on the chart the falling core R&D cost, from quarter four 2015 to quarter one 2016, despite the first-time absorption of the acquired R&D cost mentioned previously.

    您可以在圖表上清楚地看到從 2015 年第四季度到 2016 年第一季度的核心研發成本下降,儘管之前提到的收購研發成本首次被吸收。

  • Please turn to Slide 19.

    請轉到幻燈片 19。

  • As we continue to maintain core discipline across the business, we have announced today actions to advance our strategy implementation by sharpening our focus on the three main therapy areas, enhancing operational effectiveness, and adjusting cost structures.

    在我們繼續保持整個業務的核心紀律的同時,我們今天宣布了通過加強對三個主要治療領域的關注、提高運營效率和調整成本結構來推進我們戰略實施的行動。

  • We have made good progress focusing on the main therapy areas, for instance in RIA we have expanded the portfolio and are beginning to capture the benefits.

    我們在主要治療領域取得了良好進展,例如在 RIA 方面,我們擴大了產品組合併開始獲得收益。

  • In CVMD, we are broadening our portfolio, recognizing the loss of Crestor.

    在 CVMD 中,我們正在擴大我們的投資組合,認識到 Crestor 的損失。

  • And in oncology, we have one of the most exciting and balanced pipelines in the industry that we will further advance.

    在腫瘤學方面,我們擁有業內最令人興奮和最平衡的管道之一,我們將進一步推進。

  • But we plan to go faster and further.

    但我們計劃走得更快、更遠。

  • In parallel to this focus and prioritization, we will reduce costs at a global, regional, and country level, and make far greater use of shared services.

    在實現這一重點和優先次序的同時,我們將在全球、區域和國家層面降低成本,並更多地利用共享服務。

  • We plan to reshape our manufacturing base, optimizing our presence in key strategic sites, while taking into account the need to create capacity in our biologics supply chain.

    我們計劃重塑我們的製造基地,優化我們在關鍵戰略地點的存在,同時考慮到在我們的生物製劑供應鏈中創造能力的需要。

  • As well as continuing to focus on productivity and simplification, our R&D structure will benefit further from externalization, for example as we share R&D costs with key partners.

    除了繼續關註生產力和簡化,我們的研發結構將進一步受益於外部化,例如我們與主要合作夥伴分擔研發成本。

  • These changes will enhance operational effectiveness and once implemented by the end of next year, I expect it to generate around $1.1 billion in annual net benefit, versus full-year 2015.

    這些變化將提高運營效率,一旦在明年年底實施,我預計與 2015 年全年相比,每年將產生約 11 億美元的淨收益。

  • These benefits will fall mostly within the core SG&A cost line.

    這些收益將主要屬於核心 SG&A 成本線。

  • We expect to incur up to $1.5 billion in one-time restructuring charges, the majority of which are likely to be cash costs.

    我們預計將產生高達 15 億美元的一次性重組費用,其中大部分可能是現金成本。

  • It is important to emphasize that these benefits are taken into account by a full-year guidance which remains unchanged today.

    重要的是要強調,這些好處已在今天保持不變的全年指導中得到考慮。

  • Please turn to Slide 20.

    請轉到幻燈片 20。

  • You may well be familiar with this slide that summarizes the challenges and opportunities we face this year.

    您可能很熟悉這張總結我們今年面臨的挑戰和機遇的幻燈片。

  • We know that there are two clear pressures on the business.

    我們知道企業面臨兩個明顯的壓力。

  • When we think about our 2016 guidance, we [mean] the loss of exclusivity for Crestor in the United States, plus the dilutive effect of the recent acquisition and investments.

    當我們考慮我們的 2016 年指引時,我們[意味著] Crestor 在美國的獨家經營權的喪失,以及最近收購和投資的稀釋效應。

  • But our growth platforms continue consistently to perform well.

    但我們的增長平台繼續表現良好。

  • We also have a very busy year for the pipeline in the launch program.

    在啟動計劃的管道中,我們也度過了非常忙碌的一年。

  • We will continue to pursue value-creating externalization and [disposal] opportunities.

    我們將繼續追求創造價值的外部化和[處置]機會。

  • As I just mentioned, we are (inaudible) focus on cost discipline.

    正如我剛才提到的,我們(聽不清)專注於成本紀律。

  • All of these factors are within our control.

    所有這些因素都在我們的控制範圍內。

  • This why the adverse currency movement that we now expect to impact total revenues by around 2% this year, and a similar percentage on core EPS, are not included within guidance.

    這就是為什麼我們現在預計對今年總收入造成約 2% 影響的不利貨幣變動以及核心每股收益的類似百分比並未包含在指導中。

  • Please turn to Slide 21.

    請轉到幻燈片 21。

  • To conclude, I want to reiterate the guidance for 2016, which is at constant exchange rates.

    最後,我想重申 2016 年的指導方針,即按固定匯率計算。

  • We expect a low to mid single-digit percentage decline in both total revenue and core EPS.

    我們預計總收入和核心每股收益將出現中低個位數百分比下降。

  • Finally, I want to reconfirm our capital allocation priorities.

    最後,我想再次確認我們的資本配置重點。

  • We will continue to strike a balance between the interests of the business, our financial creditors, and our shareholders.

    我們將繼續在企業、金融債權人和股東的利益之間取得平衡。

  • After providing for investments in business, supporting the progressive dividend policy, and maintaining our strong investment grade credit ratings, we will keep under review any potential investment in value-enhancing and immediately earning accretive opportunities.

    在提供業務投資、支持漸進式股息政策並保持我們強大的投資級信用評級後,我們將繼續審查任何潛在的增值投資和立即賺取增值機會。

  • Thank you for listening, and I will now hand over to Sean.

    感謝您的收聽,我現在將交給肖恩。

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • Thank you, Mark, and hello, everyone.

    謝謝馬克,大家好。

  • Please turn to Slide 23.

    請轉到幻燈片 23。

  • I would like to start off by highlighting a few milestones achieved during the quarter.

    首先,我想強調本季度實現的幾個里程碑。

  • We received US Breakthrough Therapy designation for durvalumab, for bladder cancer.

    我們獲得了美國針對膀胱癌的 durvalumab 的突破性療法指定。

  • In the EU we received orphan drug designation for acalabrutinib, for a number of hematological cancers listed on this slide.

    在歐盟,我們的 acalabrutinib 獲得了孤兒藥稱號,用於本幻燈片中列出的多种血液癌症。

  • Further, we received US orphan drug designation for MEDI-551, for neuromyelitis optica, an autoimmune disease of the central nervous system.

    此外,我們還獲得了 MEDI-551 的美國孤兒藥稱號,用於治療視神經脊髓炎,一種中樞神經系統的自身免疫性疾病。

  • Finally, also in the US, Fast Track designation was received for MEDI8852, for hospitalized influenza A. These designations illustrated the quality of our pipeline, and also point to the evolution from primary care to more specialty care programs addressing unmet medical needs.

    最後,同樣在美國,住院甲型流感 MEDI8852 獲得了快速通道指定。這些指定說明了我們管道的質量,也表明了從初級保健到更多專科保健計劃的演變,以滿足未滿足的醫療需求。

  • Please turn to Slide 24.

    請轉到幻燈片 24。

  • As Pascal and Marc mentioned previously, we have seen an acceleration of the pipeline.

    正如 Pascal 和 Marc 之前提到的,我們已經看到了管道的加速。

  • Nowhere is that more evident than in our milestones in upcoming news flow first.

    沒有什麼比我們在即將到來的新聞流中的里程碑更明顯的了。

  • First, on Q1 milestones, I would like to review some late stage pipeline headlines since the last results announcement.

    首先,關於第一季度的里程碑,我想回顧一下自上次公佈業績以來的一些後期管道頭條新聞。

  • Starting with RIA, Symbicort, in the pressurised metered-dose inhaler, was approved in the EU for COPD.

    從 RIA 開始,加壓計量吸入器中的 Symbicort 在歐盟被批准用於 COPD。

  • And Bevespi, or PT003, was approved in the US for COPD.

    Bevespi 或 PT003 在美國被批准用於 COPD。

  • Zurampic received approval in the EU for gout.

    Zurampic 在歐盟獲得批准用於治療痛風。

  • In CVMD, Brilique received approval in the EU for the post-MI indication.

    在 CVMD 中,Brilique 在歐盟獲得了 MI 後適應症的批准。

  • The SOCRATES trial for stroke also read out during the quarter, though positive trends were detected, the trial missed its primary endpoint.

    中風的 SOCRATES 試驗也在本季度宣讀,儘管檢測到積極趨勢,但該試驗未達到其主要終點。

  • For oncology, starting with Tagrisso for lung cancer, we received approval in Japan at the end of March, just a few months following approvals in the US and EU.

    對於腫瘤學,從治療肺癌的 Tagrisso 開始,我們於 3 月底在日本獲得批准,僅在美國和歐盟獲得批准幾個月後。

  • We also made the decision not to restart the CAURAL trial in combination with durvalumab.

    我們還決定不重啟 CAURAL 試驗與 durvalumab 的組合。

  • We are happy to report that the FLAURA first-line trial is now fully recruited.

    我們很高興地報告,FLAURA 一線試驗現已全面招募。

  • We expect data from the second-line confirmatory trial, AURA3, in the second half of 2016, potentially already in Q3.

    我們預計二線驗證性試驗 AURA3 的數據將於 2016 年下半年公佈,可能已經在第三季度公佈。

  • Finally after a successful Phase II interim analysis, AZD3293, a base in partnership with Eli Lilly for Alzheimer's disease, will continue into a Phase III trial program.

    最後,在成功完成 II 期中期分析後,AZD3293(與禮來公司合作治療阿爾茨海默病的基地)將繼續進入 III 期試驗計劃。

  • Please turn to Slide 25.

    請轉到幻燈片 25。

  • I wanted to highlight in particular the Tagrisso first-line AURA data which were presented at the ELCC conference earlier this month.

    我想特別強調本月早些時候在 ELCC 會議上公佈的 Tagrisso 一線 AURA 數據。

  • As an oncologist I find this data particularly encouraging.

    作為一名腫瘤學家,我發現這些數據特別令人鼓舞。

  • The AURA study is a Phase I first-line trial in patients with EGFR mutated advanced non-small cell lung cancer.

    AURA 研究是針對 EGFR 突變的晚期非小細胞肺癌患者的 I 期一線試驗。

  • Although on a small sample of patients, about 60, the results were encouraging, with a confirmed response rate of 77%, and a median progression-free survival of 19.3 months.

    儘管在大約 60 名患者的小樣本中,結果令人鼓舞,確認的反應率為 77%,中位無進展生存期為 19.3 個月。

  • As a comparator, currently approved first-line medicines for EGFR mutated non-small lung cancer patients, typically provide less than one year of median progression-free survival, as per their approved labels.

    作為比較,目前批准用於 EGFR 突變非小細胞肺癌患者的一線藥物,根據其批准的標籤,通常提供不到一年的中位無進展生存期。

  • This setting is being further evaluated in the ongoing FLAURA Phase III trial.

    正在進行的 FLAURA III 期試驗正在進一步評估此設置。

  • Please turn to Slide 26.

    請轉到幻燈片 26。

  • We would like to update you on our durvalumab hematology IO collaboration with Celgene.

    我們想向您介紹我們與 Celgene 的 durvalumab 血液學 IO 合作的最新情況。

  • As you can see, the development program is extensive across disease types, with the first patient dosed in a Phase I trial in relapsed/refractory multiple myeloma.

    如您所見,該開發計劃涉及多種疾病類型,第一位患者在復發/難治性多發性骨髓瘤的 I 期試驗中接受了給藥。

  • We are committed to advancing this program, and also to the hematology space, which is an integral part of our overall oncology strategy.

    我們致力於推進該計劃,以及血液學領域,這是我們整體腫瘤學戰略的一個組成部分。

  • Please turn to Slide 27.

    請轉到幻燈片 27。

  • Finally we anticipate a very busy year ahead in terms of pipeline news flow.

    最後,我們預計在管道新聞流方面將是非常繁忙的一年。

  • We have previously communicated a PDUFA date for ZS-9 of 26 May 2016.

    我們之前已將 ZS-9 的 PDUFA 日期定為 2016 年 5 月 26 日。

  • In the second half of the year, we expect a regulatory decision on saxa/dapa for type-2 diabetes; cediranib for ovarian cancer; and CAZ AVI, all in the EU.

    今年下半年,我們預計將對 saxa/dapa 治療 2 型糖尿病做出監管決定;用於卵巢癌的西地尼布;和 CAZ AVI,都在歐盟。

  • I have a note in front of me here that actually, we just got CHMP go for CAZ AVI this morning.

    我面前有一張紙條,實際上,我們今天早上剛剛讓 CHMP 去 CAZ AVI。

  • We expect the resubmission of saxa/dapa in the US during the second quarter.

    我們預計第二季度將在美國重新提交 saxa/dapa。

  • And in the second half of 2016: Bevespi for COPD in the EU; benralizumab for severe asthma in the US and EU; the rolling submission for roxadustat in China; and potentially acalabrutinib, for the first blood cancer indication in the US.

    2016 年下半年:歐盟 COPD 的 Bevespi;在美國和歐盟用於嚴重哮喘的貝那利珠單抗; roxadustat在中國的滾動提交;和潛在的 acalabrutinib,用於美國第一個血液癌症適應症。

  • This potential regulatory submission for acalabrutinib would be for an accelerated approval.

    acalabrutinib 的潛在監管提交將加速批准。

  • Finally, we expect key data read outs for benralizumab for severe asthma, and Lynparza for gastric cancer in the second quarter.

    最後,我們預計第二季度將公佈用於嚴重哮喘的貝那利珠單抗和用於胃癌的 Lynparza 的關鍵數據。

  • And in the second half of the year, Brilinta for peripheral artery disease; Lynparza for breast and second-line ovarian cancer; selumetinib for lung cancer; the durvalumab HAWK trial for head and neck cancer; and acalabrutinib for blood cancer.

    下半年,Brilinta 治療外周動脈疾病; Lynparza 用於乳腺癌和二線卵巢癌; selumetinib 治療肺癌;頭頸癌的 durvalumab HAWK 試驗;和 acalabrutinib 治療血癌。

  • We are advancing quickly in first-line lung cancer with the MYSTIC trial, which is enrolling well, with top-line data on progression-free survival expected in the first half of 2017.

    我們正在通過 MYSTIC 試驗在一線肺癌領域快速推進,該試驗招募情況良好,預計 2017 年上半年將獲得無進展生存期的一線數據。

  • We are also advancing in first-line bladder cancer, both in durvalumab monotherapy, and in combination with tremelimumab in the DANUBE trial.

    我們還在一線膀胱癌方面取得進展,包括 durvalumab 單一療法以及與 DANUBE 試驗中的 tremelimumab 聯合療法。

  • We also have the only chemo free IO combination for first-line head and neck cancer, with the KESTREL trial.

    通過 KESTREL 試驗,我們還擁有針對一線頭頸癌的唯一無化療 IO 組合。

  • A comprehensive registration program is underway across multiple tumor types, stages of disease, and monotherapy as well as combination therapy.

    一項涵蓋多種腫瘤類型、疾病分期、單一療法和聯合療法的綜合註冊計劃正在進行中。

  • Additional combination studies of durvalumab with other immunotherapies and also chemotherapy are underway.

    durvalumab 與其他免疫療法以及化療的其他聯合研究正在進行中。

  • We're very pleased with the progression our oncology portfolio and with the advancement of our broader pipeline in 2016 and into 2017.

    我們對我們的腫瘤產品組合的進展以及我們更廣泛的產品線在 2016 年和 2017 年的進展感到非常高興。

  • I will now hand back to Pascal.

    我現在將交還給 Pascal。

  • - CEO

    - CEO

  • Thank you very much, Sean.

    非常感謝你,肖恩。

  • We now open the floor for questions.

    我們現在開始提問。

  • Before we do that let me just kind of quickly summarize what we told you today and ask if you can move to Slide 29.

    在我們這樣做之前,讓我快速總結一下我們今天告訴您的內容,並詢問您是否可以轉到幻燈片 29。

  • Essentially the message is we are very much on track.

    從本質上講,信息是我們已經步入正軌。

  • Q1 reflects the progress we're making across the entire company.

    第一季度反映了我們在整個公司取得的進展。

  • It also reflects the implementation of some of the commitments we gave you, in particular reduction of SG&A costs.

    它還反映了我們對您的一些承諾的實施,特別是降低 SG&A 成本。

  • It reflects the progress of our pipeline.

    它反映了我們管道的進度。

  • The important point I would like to make to you is that, we are really kind of at a pivot point, if you will.

    我想對你說的重要一點是,如果你願意的話,我們真的處於一個關鍵點。

  • We have achieved, we built our pipeline with great success, in fact more than we expected to.

    我們已經取得了成功,我們成功地建立了我們的管道,實際上比我們預期的要多。

  • And we have now a tremendous number exciting projects in oncology, in specialty care, but across the entire portfolio including respiratory and cardiovascular disease.

    我們現在在腫瘤學、專科護理方面有大量令人興奮的項目,但涵蓋了包括呼吸系統和心血管疾病在內的整個產品組合。

  • And so as a result of it, we really have to accelerate the shift to a specialty care, more balanced specialty care/primary care portfolio.

    因此,我們真的必須加快向專業護理、更平衡的專業護理/初級護理組合的轉變。

  • And so the program we've announced today is really reflecting this pivot to a more balanced specialty care/primary care portfolio, and reflecting the strength of our -- we've see in the pipeline and the need for us to invest more in oncology; to invest more in preparing all those launches; and to invest in specialty care; as we reduce costs in other parts of the business, to reduce SG&A and facilitate this redeployment of resources.

    因此,我們今天宣布的計劃確實反映了這種向更平衡的專業護理/初級護理組合的轉變,並反映了我們的力量——我們已經看到了管道中的力量以及我們在腫瘤學上進行更多投資的必要性;投入更多資金準備所有這些發射;並投資於專業護理;隨著我們降低業務其他部分的成本,減少 SG&A 並促進資源的重新部署。

  • So all in all, very much on track with what we told you.

    所以總而言之,我們告訴你的一切都在軌道上。

  • Pipeline is building in line, in fact, faster than we thought, and we are starting to shift, and preparing ourselves for the launch of these new products.

    事實上,管道正在建設中,比我們想像的要快,我們正在開始轉變,並為這些新產品的發布做準備。

  • We reconfirm our guidance for the year.

    我們再次確認我們今年的指導方針。

  • And we'll now stop here and I'll open the floor for with questions, with Tim Anderson at Bernstein.

    我們現在就到此為止,我將與伯恩斯坦的蒂姆·安德森一起開始提問。

  • Tim, go ahead.

    蒂姆,繼續。

  • - Analyst

    - Analyst

  • Thank you.

    謝謝你。

  • I'm trying to understand the comments about sharpening focus and what that means exactly.

    我試圖理解有關銳化焦點的評論以及這到底意味著什麼。

  • So you talked about that benefiting primarily SG&A.

    所以你談到了主要受益於 SG&A 的問題。

  • That would suggest that narrowing focus is not really on the R&D asset side, but it's almost more on the in-line brand side.

    這表明縮小的重點並不是真正在研發資產方面,而是幾乎更多地集中在在線品牌方面。

  • My question is, does that narrowing focus imply that you're going to sell off or partner in-line brands?

    我的問題是,縮小關注點是否意味著您要出售或與在線品牌合作?

  • And if so, is there any chance that these are wholesale divestitures of entire therapeutic areas, or these kind of items one at a time?

    如果是這樣,這些是否有可能是整個治療領域的批發剝離,或者一次只剝離這些項目?

  • And then a second question is on the MYSTIC trials.

    然後第二個問題是關於 MYSTIC 試驗。

  • So as you know the read out in first half 2017, that's PFS, is it pretty clear there's a delayed response from IO, and with the CTLA4s specifically there is sometimes pseudo-progression before there's regression.

    因此,正如您所知,2017 年上半年的讀出結果是 PFS,很明顯 IO 有延遲響應,特別是 CTLA4s,有時在回歸之前會出現偽進展。

  • So it seems that with PFS as the first read out, that could embed some real risk.

    因此,似乎將 PFS 作為第一個讀出,這可能會帶來一些真正的風險。

  • Can you comment on that, and then will we see the [LS] data in 2017 or not or that likely be a 2018 event?

    您能否對此發表評論,然後我們是否會在 2017 年看到 [LS] 數據,或者這可能是 2018 年的事件?

  • - CEO

    - CEO

  • Right, thanks very much, Tim.

    好的,非常感謝,蒂姆。

  • So Sean, if you want answer in a minute the MYSTIC questions.

    所以肖恩,如果你想在一分鐘內回答神秘的問題。

  • The first question about narrowing the focus, Tim, thanks very much for this question, because it really helps really sort of clarify the comments that we made, and what we are trying to achieve here.

    關於縮小焦點的第一個問題,蒂姆,非常感謝這個問題,因為它真的有助於澄清我們所做的評論,以及我們在這裡試圖實現的目標。

  • Essentially focusing means we are going to really focus on oncology, cardiovascular, diabetes, respiratory medicine, and we'll continue, and in fact, accelerate the partnering of assets in CNS, in infection, and including in autoimmune.

    本質上專注意味著我們將真正專注於腫瘤學、心血管、糖尿病、呼吸內科,我們將繼續,事實上,加速中樞神經系統、感染和自身免疫領域的資產合作。

  • Now, we are going to invest more in oncology and in other specialty care products.

    現在,我們將更多地投資於腫瘤學和其他專業護理產品。

  • So as a result, certainly we will -- this focusing has an impact on R&D, but a lot of what we said would be reinvested.

    因此,我們當然會 - 這種關注對研發產生影響,但我們所說的很多內容都會被重新投資。

  • And so we believe that this focusing here will help us maintain the R&D budget to deliver, we told you we would try to contain it whilst investing more on oncology.

    因此,我們相信,這種關注將幫助我們維持研發預算以交付,我們告訴過你我們會盡量控制它,同時在腫瘤學上投入更多。

  • On the [SG&A] side, essentially we are continuing to reduce the SG&A cost as we told you we would, and basically those savings will follow to the bottom line.

    在 [SG&A] 方面,基本上我們會繼續降低 SG&A 成本,就像我們告訴過你的那樣,基本上這些節省將達到底線。

  • In fact, the savings we've communicated of $1.1 billion are the net savings.

    事實上,我們所傳達的 11 億美元的節省是淨節省。

  • We haven't communicated more details, but I can tell you that, in fact, the savings are bigger than that; and we are making a big reinvestment in oncology and specialty care as a whole.

    我們還沒有溝通更多的細節,但我可以告訴你,實際上,節省的錢遠不止於此;我們正在對整個腫瘤學和專業護理進行大量再投資。

  • And the $1.1 billion is the net of all of those movements.

    11 億美元是所有這些變動的淨額。

  • Sean, you want to cover the --

    肖恩,你想報導——

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • Yes, so Tim, let me see if I answer this, because I'm probably going to reiterate things that we said at the end of year for 2015.

    是的,蒂姆,讓我看看我是否回答這個問題,因為我可能會重申我們在 2015 年年底所說的話。

  • Overall survival, I would say that the balance of data that we're getting in immuno-oncology across companies, seems to indicate that overall survival is really necessary to capture the full benefit of immunotherapy for cancer.

    總生存期,我想說我們在各公司的免疫腫瘤學中獲得的數據平衡,似乎表明總生存期對於獲得癌症免疫療法的全部益處確實是必要的。

  • Even recently at AACR we got more data, albeit in head and neck cancer, not in non-small cell lung cancer, indicating that the overall survival benefit, which was quite robust, was not very well captured in progression-free survival or in response rate.

    即使是最近在 AACR 上,我們也獲得了更多的數據,儘管是頭頸癌,而不是非小細胞肺癌,這表明相當穩健的總體生存獲益並沒有很好地反映在無進展生存期或響應中速度。

  • So with regard to MYSTIC taking all of this into account, we're very fortunate to have the opportunity to elevate overall survival to a co-primary endpoint.

    因此,關於 MYSTIC 考慮到所有這些因素,我們非常幸運有機會將總體生存率提高到一個共同的主要終點。

  • And that does necessitate an increase in the size of the trial, the power for that endpoint.

    這確實需要增加試驗的規模,即該終點的力量。

  • But our recruitment has been so robust that we've been able to do that without actually delaying our guidance that we should have -- data in the first half of next year.

    但是我們的招聘非常強勁,以至於我們能夠做到這一點,而不會真正延遲我們應該擁有的指導——明年上半年的數據。

  • - Analyst

    - Analyst

  • I'm sorry, I guess my question is on the PFS specifically, we get pseudo-progression with CTLA4s, doesn't that kind of put that endpoint at risk?

    抱歉,我想我的問題具體是關於 PFS 的,我們使用 CTLA4s 獲得了偽進展,這不會使終點處於危險之中嗎?

  • And Pascal, my question on the narrowing focus is really, does that involve out-licensing or sale of branded in-line products?

    帕斯卡,我關於縮小焦點的問題是,這是否涉及品牌在線產品的對外許可或銷售?

  • - CEO

    - CEO

  • Sorry, I should've been clearer there.

    對不起,我應該更清楚那裡。

  • No, I mean certainly we will continue partnering in-line products, just like we've done it with Plendil in China where we think we can generate additional growth, leveraging the scales, capabilities, and investment of partners.

    不,我的意思是我們當然會繼續與在線產品合作,就像我們在中國與 Plendil 所做的一樣,我們認為我們可以在中國利用合作夥伴的規模、能力和投資產生額外的增長。

  • But there is no intent to out-license large products.

    但無意向外授權大型產品。

  • Certainly continued partnering, but no -- we might divest smaller products as we've done in the past, but that's about it, Tim.

    當然會繼續合作,但不會——我們可能會像過去那樣剝離較小的產品,但僅此而已,蒂姆。

  • And so if we exit a therapeutic area, it's going to be driven by the focusing on the core TA, for instance, in infection, we might go for partners for our new products in antibiotics.

    因此,如果我們退出一個治療領域,它將受到對核心 TA 的關注的推動,例如,在感染方面,我們可能會為我們的抗生素新產品尋找合作夥伴。

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • So let me clarify, Tim, for CTLA4, are you referring to determine the mesothelioma data?

    所以讓我澄清一下,蒂姆,對於 CTLA4,你指的是確定間皮瘤數據嗎?

  • - Analyst

    - Analyst

  • No, no, there's been a recognized phenomenon, when you give CTLA4, is that the tumor sometimes progresses before it regresses, so this is from prior data sets in tumors like melanoma, for example, that's led to the notion that PFS is not a great endpoint.

    不,不,有一個公認的現象,當你給予 CTLA4 時,腫瘤有時會在消退之前進展,所以這是來自黑色素瘤等腫瘤的先前數據集,例如,這導致了 PFS 不是偉大的終點。

  • So if PFS is the first readout with MYSTIC, and MYSTIC is looking at a CTLA4 combo, doesn't that potentially put that readout at risk of being negative on the PFS, just the PFS side, I understand the OS will capture the benefit, but my question is really on the PFS side.

    因此,如果 PFS 是 MYSTIC 的第一個讀數,而 MYSTIC 正在查看 CTLA4 組合,那麼這是否可能使該讀數在 PFS 上處於負面風險,只是 PFS 方面,我知道操作系統將獲得好處,但我的問題實際上是在 PFS 方面。

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • Yes, so the pseudo-progression phenomenon is what you're referring to.

    是的,所以你說的偽進展現象就是這樣。

  • So couple of things about MYSTIC.

    關於 MYSTIC 的一些事情。

  • One, it does have a single agent durvalumab in both PD-L1 positive and PD-L1 negative patients, so we have an opportunity to look at the single agent durvalumab.

    第一,它確實在 PD-L1 陽性和 PD-L1 陰性患者中都有單藥 durvalumab,因此我們有機會研究單藥 durvalumab。

  • I think, is there a risk to PFS, I think it's less from pseudo-progression, I think it's more from the possibility that PFS doesn't capture the benefit of immunotherapy completely.

    我認為,PFS 是否存在風險,我認為假性進展的風險較小,我認為更多的是 PFS 沒有完全獲得免疫療法益處的可能性。

  • We've seen that in other trials, not just with CTLA4, but also with PD1, PD-L1 agents, and I think most recently, the CheckMate-141 data that was presented at AACR in head and neck cancer, had what looked like a pretty nice overall survival benefit, but no PFS benefit and a very modest non-significant difference in overall response rate.

    我們已經在其他試驗中看到,不僅是 CTLA4,還有 PD1、PD-L1 藥物,我認為最近在 AACR 上展示的頭頸癌 CheckMate-141 數據看起來像相當不錯的總體生存獲益,但沒有 PFS 獲益,總體反應率有非常適度的非顯著差異。

  • So we have accounted for that risk in the re-prioritization of endpoints and the change in size for MYSTIC.

    因此,我們在端點的重新優先級排序和 MYSTIC 的大小變化中考慮了這種風險。

  • - Analyst

    - Analyst

  • Thank you.

    謝謝你。

  • - CEO

    - CEO

  • Thanks, Tim.

    謝謝,蒂姆。

  • So moving to Simon Baker at Exane, Simon, go ahead.

    所以搬到 Exane 的西蒙貝克,西蒙,繼續吧。

  • - Analyst

    - Analyst

  • Thanks so much for taking the questions.

    非常感謝您提出問題。

  • First thing and continuing on from Tim's question on sharpening focus.

    首先,繼續提姆關於提高注意力的問題。

  • One way, presumably, of accelerating the sharpening of focus would be to move from doing product by product deals to larger partnerings or divestments or carve-outs of products.

    據推測,加速重點突出的一種方法是從逐個產品交易轉移到更大的合作夥伴關係或撤資或產品分拆。

  • Is that something that you would consider doing, either en masse or by therapeutic area, rather than the single product deals?

    您是否會考慮整體或按治療領域而不是單一產品交易來做這件事?

  • And then secondly, a question for Luke on China.

    其次,Luke 有一個關於中國的問題。

  • Your performance in China in Q1 was very solid.

    你們第一季度在中國的表現非常穩健。

  • There's been very divergent performance across your peer groups, so I just wondered if you could share your thoughts on the market dynamics in China at the moment, and why you seem to be significantly outperforming some of your competitors?

    您所在的同行群體的表現非常不同,所以我想知道您是否可以分享您對目前中國市場動態的看法,以及為什麼您的表現似乎明顯優於一些競爭對手?

  • And then finally a question on MEDI-4166, the PCSK9/GLP-1 combo, I wonder if you, now that that's moved into Phase II, give us an update on your development plans for that molecule?

    最後是關於 MEDI-4166 的問題,即 PCSK9/GLP-1 組合,我想知道您是否在進入 II 期後向我們介紹了您對該分子的開發計劃?

  • Thanks so much.

    非常感謝。

  • - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

    - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

  • So I think it's a combination, we have a very good commercial organization in China.

    所以我認為這是一個組合,我們在中國有一個非常好的商業組織。

  • We're investing extensively in R&D.

    我們在研發方面進行了大量投資。

  • You've heard announcements with WuXi.

    你已經聽過 WuXi 的公告。

  • We also have a discovery unit in Shanghai.

    我們在上海也有一個發現單位。

  • But also we're benefiting from a very attractive combination of products for China right now.

    但我們也從目前對中國非常有吸引力的產品組合中受益。

  • I think if we looked in ten years' time, that collection of products may not be as competitive.

    我認為,如果我們回顧十年後,產品系列可能沒有那麼有競爭力。

  • But right now it's extremely competitive.

    但現在它的競爭非常激烈。

  • So we got a good sequence here.

    所以我們在這裡得到了一個很好的序列。

  • We've got products like Pulmicort.

    我們有 Pulmicort 等產品。

  • If we look at Pulmicort, around half our sales of Pulmicort come from the top 1,000 nebulizing centers.

    如果我們看看 Pulmicort,我們大約一半的 Pulmicort 銷售額來自前 1,000 家霧化中心。

  • The next bracket, the other half is around 6,000 other centers.

    下一個支架,另一半是大約 6,000 個其他中心。

  • And that expansion continues.

    這種擴張仍在繼續。

  • So there are lots of opportunities with products like that.

    所以這樣的產品有很多機會。

  • Also some of our older products such as metoprolol continue to grow.

    我們的一些老產品,如美托洛爾,也在繼續增長。

  • So it's a good mix of products.

    所以這是一個很好的產品組合。

  • Then if we look into the medium to longer term, a product like Tagrisso is extremely exciting in terms of the value that it could add to treatment for patients in China.

    然後,如果我們從中長期來看,就可以為中國患者的治療增加的價值而言,像 Tagrisso 這樣的產品非常令人興奮。

  • - CEO

    - CEO

  • I think in China, Simon, you've got to consider a few things.

    我認為在中國,西蒙,你必須考慮一些事情。

  • First of all, we have a tremendous pipeline portfolio that really fits the needs of China at this point this time.

    首先,我們擁有龐大的管道產品組合,真正適合中國此時此刻的需求。

  • Two, we have a tremendous team, really, a fantastic team of people there.

    第二,我們有一個很棒的團隊,真的,那裡有一群很棒的人。

  • And thirdly, we've invested a lot, continue to invest, as Luke was saying.

    第三,正如盧克所說,我們已經投入了很多,繼續投資。

  • And so this combination is leading to, we believe, the great results you see, and we believe they are sustainable.

    因此,我們相信,這種結合會帶來您所看到的偉大成果,而且我們相信它們是可持續的。

  • By the way in Q1, just for you to consider, is that last year the first quarter we had an increase in inventory in China.

    順便說一句,在第一季度,僅供您考慮,去年第一季度我們在中國的庫存有所增加。

  • This quarter we had a decrease, so the inventory movements played against us in the quarter this year, when you compare to last year.

    本季度我們有所減少,因此與去年相比,今年這個季度的庫存變動對我們不利。

  • So our market sales are even better than what you see in the reported sales in China.

    所以我們的市場銷售甚至比你在中國報告的銷售中看到的還要好。

  • So certainly very strong performance, far above the market growth rate

    所以表現肯定非常強勁,遠高於市場增長率

  • As far as the focus, you know I don't think I can comment more specifically and give you a lot more than what we have said so far.

    至於重點,你知道我不能更具體地發表評論,也不能給你比我們目前所說的更多的東西。

  • But the focus, you know, we're considering all sorts of options.

    但是重點,你知道,我們正在考慮各種選擇。

  • But with essentially, it's really continuing to sharpen the focus in the core areas we have communicated before.

    但從本質上講,它確實在繼續加強我們之前交流過的核心領域的重點。

  • The place where we could potentially partner more broadly [in this] is antibiotics, for instance, where we have a couple of very interesting products.

    我們可以[在這方面]更廣泛地合作的地方是抗生素,例如,我們有幾個非常有趣的產品。

  • CAZ AVI, for instance, just got approved in Europe, but it is not an area where we want to focus, and we may partner that.

    例如,CAZ AVI 剛剛在歐洲獲得批准,但這不是我們想要關注的領域,我們可能會與之合作。

  • CNS is another area, of course.

    當然,CNS 是另一個領域。

  • So it's essentially going to be -- and autoimmune is an area where we also look for partners, except for anifrolumab which we decided to make an exception of and keep to ourselves.

    所以它基本上是——自身免疫是一個我們也在尋找合作夥伴的領域,除了我們決定破例並保留給我們自己的 anifrolumab 之外。

  • That will enable us to invest more.

    這將使我們能夠進行更多投資。

  • With CAZ AVI, by the way, just a clarification, when I say approval it's actually the CHMP positive recommendation.

    順便說一下,對於 CAZ AVI,只是一個澄清,當我說批准時,它實際上是 CHMP 的積極建議。

  • Of course, we still have to have final approval, but it's a very nice signal for this product.

    當然,我們還需要最終的批准,但這對這款產品來說是一個非常好的信號。

  • So that's really what it is we are doing, and in fact we've communicated that before, but we're doing it in accelerated manner and we also are including there the autoimmune assets which we had not made as clear as -- we had not met clearly candidates for partnering in the past.

    所以這就是我們正在做的事情,事實上我們之前已經傳達過這一點,但我們正在以加速的方式進行,我們還包括我們沒有明確說明的自身免疫資產——我們已經過去沒有遇到明確的合作候選人。

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • Thank you, Simon, for asking taking a question about a Phase I/II molecule, that's fun.

    西蒙,謝謝你提出有關 I/II 相分子的問題,這很有趣。

  • So MEDI-4166, if you at our full Q1 results, you'll see that it moved into Phase II.

    所以 MEDI-4166,如果你看到我們第一季度的完整結果,你會看到它進入了第二階段。

  • It did that in Q1 of 2016, so our MedImmune group is moving that forward very quickly.

    它在 2016 年第一季度做到了這一點,因此我們的 MedImmune 團隊正在迅速推進這一進程。

  • - CEO

    - CEO

  • So you'll have to wait a little bit longer to get more information.

    因此,您需要稍等片刻才能獲得更多信息。

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • I'm not going to tell you more.

    我不會告訴你更多。

  • - CEO

    - CEO

  • We have (inaudible) -- in early development, by the way, which is also moving quite nicely but we need more data before we can give you an update.

    我們有(聽不清)- 順便說一句,這在早期開發中也進展順利,但我們需要更多數據才能為您提供更新。

  • Let me just go back by the way to this [commercialization] to be totally 100% clear.

    讓我順便回到這個 [商業化] 來完全 100% 清楚。

  • In many of those areas like autoimmune, for instance, we have tremendous antibodies for infections.

    例如,在自身免疫等許多領域,我們擁有強大的感染抗體。

  • We have a tremendous team of scientists, and they're doing a fantastic job.

    我們擁有一支龐大的科學家團隊,他們的工作非常出色。

  • Our intent there is to continue doing research and early development in those areas, and retain the teams we have, because they're doing a fantastic job.

    我們的意圖是繼續在這些領域進行研究和早期開發,並保留我們擁有的團隊,因為他們做得非常出色。

  • So when we talk about partnering, we talk about partnering at the development stage, for development and commercialization of those assets, but we certainly will continue doing some research in those areas.

    因此,當我們談論合作時,我們談論的是在開發階段的合作,用於這些資產的開發和商業化,但我們當然會繼續在這些領域進行一些研究。

  • So next question is from Diana Na, JPMorgan.

    那麼下一個問題來自摩根大通的 Diana Na。

  • Diana, we'll go to you.

    戴安娜,我們去找你。

  • - Analyst

    - Analyst

  • Hi, thanks for taking my questions, I have three questions please.

    您好,感謝您提出我的問題,我有三個問題。

  • So first, what key data will you be presenting at ASCO, and what updates will you providing at your ASCO analyst meeting, please?

    那麼首先,您將在 ASCO 上展示哪些關鍵數據,以及您將在 ASCO 分析師會議上提供哪些更新?

  • Then secondly, so Merck has filed already with their PD-1 in head and neck cancer, and I'm wondering where this leaves you in terms of the HAWK study and the potential for fast-track filing for durvalumab, please?

    其次,默克公司已經在頭頸癌中提交了他們的 PD-1,我想知道這在 HAWK 研究和 durvalumab 快速申請的潛力方面給你留下了什麼?

  • And then thirdly, despite the addition of the PEGASUS data onto the label, Brilinta sales trajectory hasn't changed very much.

    第三,儘管在標籤上添加了 PEGASUS 數據,Brilinta 的銷售軌跡並沒有太大變化。

  • Should we expect an inflection or a continuation of the current trend, please?

    請問,我們應該期待當前趨勢的拐點還是延續?

  • Thank you.

    謝謝你。

  • - CEO

    - CEO

  • Thank you, Diana, one question, and by the way, with PEGASUS, I assume you are talking about the US, because Europe we are still in the process of getting a reimbursement, we're only launching in Germany and the UK, so it's very early days.

    謝謝你,戴安娜,有一個問題,順便說一句,關於 PEGASUS,我想你說的是美國,因為歐洲我們仍在獲得報銷的過程中,我們只在德國和英國推出,所以現在還為時尚早。

  • So maybe Luke, you could start with the PEGASUS question, and then Sean, cover the other two?

    那麼也許 Luke,你可以從 PEGASUS 問題開始,然後是 Sean,討論其他兩個問題?

  • - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

    - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

  • So the trend is, it's a positive trend, so at the end of last year around 8% of PEGASUS scripts were with 60, and we're up to around 14% now, and actually it's even trending higher than that.

    所以趨勢是,這是一個積極的趨勢,所以在去年年底,大約 8% 的 PEGASUS 腳本有 60 個,現在我們達到了 14% 左右,實際上它的趨勢甚至更高。

  • But I would say, if we look at the number of people being prescribed 60, the bulk of them are coming off of the 90 so it's very much in line with the label.

    但我要說的是,如果我們看一下開出 60 人處方的人數,他們中的大部分人都在 90 人之外,所以這與標籤非常相符。

  • The other thing is, if we look at the guidelines, we have a Class I recommendation for treatment up to and beyond 12 months, the dual antiplatelet treatment.

    另一件事是,如果我們看一下指南,我們對長達 12 個月和超過 12 個月的治療有 I 類建議,即雙重抗血小板治療。

  • We also have a Class 2 recommendation supporting Brilinta over and above clopidogrel.

    我們還有 2 級推薦,支持 Brilinta 優於氯吡格雷。

  • So these are things which are positive, and actually if we look at the weeklies that we've just got in now, overall they've moved up to 12% which is a new high.

    所以這些都是積極的事情,實際上,如果我們看看我們現在剛剛進入的周刊,總體上他們已經上升到 12%,這是一個新高。

  • So it is a build.

    所以這是一個構建。

  • I think the key thing is if you look at the trends, when people are discharged from the hospital, and this is true for clopidogrel, it's true for [Effient] as well, we lose a lot of people in that first couple of months.

    我認為關鍵是如果你看看趨勢,當人們出院時,氯吡格雷是這樣,[Effient] 也是如此,我們在頭幾個月失去了很多人。

  • And so that's a big focus for us, is to make sure that they discharged, then what we can see is if they go out to 12 months, then they have a higher chance of being switched to 60.

    所以這對我們來說是一個很大的重點,就是確保他們出院,然後我們可以看到,如果他們出院到 12 個月,那麼他們有更高的機會被切換到 60。

  • So this collection of positives, hopefully should further drive growth.

    因此,這些積極因素有望進一步推動增長。

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • So I'll give a few highlights for the ASCO first, and then I'll get on to HAWK.

    因此,我將首先介紹 ASCO 的一些亮點,然後再介紹 HAWK。

  • So what we're talking about here is submissions of abstracts, so as not everything is finalized, I want to be careful to qualify that.

    所以我們在這裡談論的是提交摘要,所以不是所有的事情都已經完成,我想小心地限定它。

  • So with regard to our DNA damage response portfolio, we have Lynparza monotherapy in ovarian cancer.

    因此,關於我們的 DNA 損傷反應組合,我們在卵巢癌中有 Lynparza 單一療法。

  • We also have early trials, both monotherapy and combination, that we will present, and also updates on the WEE1 inhibitor AZD1775.

    我們也有早期試驗,包括單一療法和聯合療法,我們將展示這些試驗,並更新 WEE1 抑製劑 AZD1775。

  • For Tagrisso, I alluded to this a little bit, we're going to present some brain metastasis data from the BLOOM trial.

    對於 Tagrisso,我稍微提到了這一點,我們將展示 BLOOM 試驗的一些腦轉移數據。

  • For immuno-oncology, we're going to talk about durvalumab in bladder cancer, and as I mentioned that's an indication that has Breakthough designation, recently granted Breakthough designation from the FDA.

    對於免疫腫瘤學,我們將討論膀胱癌中的 durvalumab,正如我提到的,這是一個具有突破性指定的適應症,最近獲得了 FDA 的突破性指定。

  • The determined data, obviously the trial was negative top line, we announced that before, but you will get a detailed look at the data.

    確定的數據,顯然是試行負頂線,我們之前公佈過,但是你會得到詳細的數據看。

  • And some early combination data in IO.

    以及IO中的一些早期組合數據。

  • And then acalabrutinib as well will have a couple abstract updates, and there is the potential for FALCON results as well.

    然後 acalabrutinib 也將有一些摘要更新,並且也有可能獲得 FALCON 結果。

  • And then the next question was HAWK, given the Merck filing.

    考慮到默克公司的備案,下一個問題是 HAWK。

  • The HAWK data we expect in the second half of 2016 has Fast Track designation from the FDA, and should the data support it, obviously, we can still file the data.

    我們預計 2016 年下半年的 HAWK 數據將獲得 FDA 的快速通道指定,如果數據支持它,顯然,我們仍然可以歸檔數據。

  • Again, accelerated approval of an agent in an indication doesn't close out further submission in that indication, so our hope is that if HAWK's positive the FDA will have both filings in front of them simultaneously, and can evaluate and make their own decision.

    同樣,加快批准某項適應症的代理人並不會結束對該適應症的進一步提交,因此我們希望,如果 HAWK 的積極態度,FDA 將同時收到這兩項申請,並可以評估並做出自己的決定。

  • - CEO

    - CEO

  • Thank you, Sean and Luke.

    謝謝肖恩和盧克。

  • Sachin at Bank of America, Sachin, go ahead.

    美國銀行的 Sachin,Sachin,繼續。

  • - Analyst

    - Analyst

  • Hi, a couple of questions please.

    你好,請問幾個問題。

  • First on the treme combo, you're not citing next presentation of data, so wondering if when you'd have the next update for the Phase I lung, and when we could expect the PFS from that?

    首先,關於 treme 組合,您沒有引用下一次數據展示,所以想知道您何時會進行 I 期肺的下一次更新,以及我們何時可以從中獲得 PFS?

  • And then data for the combination in tumors beyond lung.

    然後是肺以外腫瘤的組合數據。

  • The reason for the question is Bristol is alluding to both sets of data at ASCO.

    問題的原因是 Bristol 暗示了 ASCO 的兩組數據。

  • Secondly on CAURAL, you've outlined, you start with recruitment of the Tagrisso durva, it sounds like more of a trial design issue [to be] considering Tagrisso durva with a new trial design.

    其次,在 CAURAL 上,你已經概述了,你從招募 Tagrisso durva 開始,這聽起來更像是一個試驗設計問題[要]考慮採用新的試驗設計來考慮 Tagrisso durva。

  • Any color you can give around that?

    你可以給它塗上什麼顏色?

  • And then just one financial, you've clearly outlined continue that [fight] for earnings accretive bolt on deals.

    然後只是一個財務,你已經清楚地概述了繼續 [fight] 以增加交易的收益。

  • I wonder if you could just clarify that statement in light of two deals last year and the need for an earnings accretive deal now, given that by the time if you announce it today and it closed, you're basically sitting close to an earnings inflection.

    我想知道你是否可以根據去年的兩筆交易以及現在對增加收益的交易的需求來澄清這一說法,因為如果你今天宣布並關閉,你基本上已經接近收益拐點.

  • So could you just outline your thoughts around that?

    那麼你能概述一下你的想法嗎?

  • Thank you.

    謝謝你。

  • - CEO

    - CEO

  • Yes, thanks, Sachin, so maybe let me cover the last one, and then, Sean, if you want to cover the other two, you have the treme the Phase I data and then Tagrisso, CAURAL.

    是的,謝謝,薩欽,所以也許讓我介紹最後一個,然後,肖恩,如果你想介紹另外兩個,你有第一階段的數據,然後是 CAURAL 的 Tagrisso。

  • So on the earnings question, actually, Sachin, what I guess we wanted to signal is that in the last two to three years, we have really worked very hard to rebuild our pipeline, both internally but also externally, and we've had a number acquisitions.

    所以關於收益問題,實際上,Sachin,我想我們想表達的是,在過去的兩到三年裡,我們真的非常努力地重建我們的渠道,無論是在內部還是在外部,我們已經收購數量。

  • And if you look at those acquisitions, they were all aimed at strengthening the pipeline in our core [desire] areas.

    如果你看一下這些收購,它們都是為了加強我們核心[願望]領域的管道。

  • But now what we have is a full pipeline, and it is getting strength day after day.

    但現在我們擁有的是一條完整的管道,而且它日復一日地變得強大。

  • Tagrisso is a good example of a product is making incredible progress.

    Tagrisso 是產品取得令人難以置信的進步的一個很好的例子。

  • I mean a year ago people thought Clovis had a better product than we did, and then today they don't have approval and we have a product that is really making enormous progress.

    我的意思是一年前人們認為 Clovis 的產品比我們做的更好,然後今天他們沒有獲得批准,而我們的產品確實取得了巨大的進步。

  • But as a result of it, we have to put more money into developing and preparing the launch of those products.

    但因此,我們必須投入更多資金來開發和準備這些產品的發布。

  • So essentially we've said, okay, we're going to focus now on execution, turning this pipeline into a reality for patients and our shareholders.

    所以基本上我們已經說過,好吧,我們現在將專注於執行,將這條管道變成患者和我們股東的現實。

  • And any acquisitions we would consider which still reflect the criteria we had before, but on top of it, we added this criteria of the fact it should be a earnings accretive.

    我們會考慮的任何收購仍然反映了我們之前的標準,但最重要的是,我們添加了這個標準,即它應該是一個收益增長的事實。

  • Now, doing we need an acquisition to succeed?

    現在,我們需要收購才能成功嗎?

  • We believe we don't but if we file an acquisition that would be indeed earnings accretive and would continue to strengthen our strategy and our pipeline and our portfolio, we would certainly do it.

    我們相信我們不會,但如果我們提出一項確實會增加收益並會繼續加強我們的戰略、我們的管道和我們的投資組合的收購,我們肯定會這樣做。

  • Beyond that I cannot say much more.

    除此之外,我不能說更多。

  • Sean, you want to cover the other two?

    肖恩,你想掩護另外兩個嗎?

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • Yes, let me start with CAURAL.

    是的,讓我從 CAURAL 開始。

  • So as we had communicated later last year, we saw an interstitial lung disease signal in the CAURAL trial, the combination of the durvalumab with Tagrisso, and in further analysis of that we, as I said, decided not to restart enrollment of that trial.

    因此,正如我們去年晚些時候溝通的那樣,我們在 CAURAL 試驗中看到了間質性肺病信號,即 durvalumab 與 Tagrisso 的組合,並且在進一步分析中,正如我所說,我們決定不重新開始該試驗的註冊。

  • And we do not have intention of further studying that combination.

    我們無意進一步研究該組合。

  • With regard to 006, the Phase I trial, we are continuing to expand the trial.

    關於006一期試驗,我們正在繼續擴大試驗。

  • We do not currently have a particular date for when we will announce or share the data from that expansion.

    我們目前沒有具體的日期來宣布或共享該擴展包的數據。

  • And then I think I went through pretty extensively what we intend to have at ASCO specifically.

    然後我想我已經相當廣泛地了解了我們打算在 ASCO 上具體擁有的東西。

  • - CEO

    - CEO

  • Thanks, Sean.

    謝謝,肖恩。

  • Andrew?

    安德魯?

  • Andrew Baum at Citi?

    花旗的安德魯鮑姆?

  • Andrew, go ahead.

    安德魯,繼續。

  • - Analyst

    - Analyst

  • Three questions please.

    請教三個問題。

  • I'm not quite as [facile] as Sachin.

    我不像 Sachin 那樣 [輕率]。

  • Astra's been linked to the Medivation in (inaudible).

    Astra 與(聽不清)中的冥想有關。

  • Sanofi has obviously very publicly put their cards on the table.

    賽諾菲顯然非常公開地公開了他們的底牌。

  • I wonder if you'd care to comment on the appetite for engaging in a very competitive bidding process for this asset, given the earnings accretion which is more the focus now than, let's say, the pipeline that you've outlined.

    我想知道你是否願意評論對這項資產進行非常有競爭力的投標過程的興趣,考慮到收益增長現在比你概述的管道更受關注。

  • Second, there's been some notable departures from your MedImmune and Astra business on the R&D side.

    其次,在研發方面與你們的 MedImmune 和 Astra 業務有一些明顯的不同。

  • So, Ed Bradley retired, and your head of development, and your IO research head have gone to competitors.

    所以,Ed Bradley 退休了,你的開發主管和你的 IO 研究主管都去了競爭對手那裡。

  • Could you outline replacement for those positions, and the impact, if any, on the organization?

    您能否概述這些職位的更換情況,以及對組織的影響(如果有)?

  • And then finally, with regards to the shaping focus initiative, it does mention R&D productivity as well as SG&A and marketing, so how should we think about any change in the current relationship between the AstraZeneca and MedImmune organization, either as a function of that initiative expressly, or other factors that may be going on concurrently?

    最後,關於塑造重點計劃,它確實提到了研發生產力以及 SG&A 和營銷,那麼我們應該如何考慮阿斯利康和 MedImmune 組織之間當前關係的任何變化,無論是作為該計劃的功能明確地,或其他可能同時發生的因素?

  • - CEO

    - CEO

  • Thanks, Andrew, a few great questions.

    謝謝,安德魯,幾個很好的問題。

  • Medivation, it's a good question but I'm sure you don't expect me to really answer that question.

    冥想,這是一個很好的問題,但我相信你不會期望我真正回答這個問題。

  • So apart from what I've just said in answer to Sachin's question, I really wouldn't want to comment more than that.

    因此,除了我剛剛在回答 Sachin 的問題時所說的內容之外,我真的不想發表更多評論。

  • I guess you have to see what we do, but I have to say we are very committed, we are very focused on delivering our pipeline, that's really our number one priority.

    我想你必須看看我們在做什麼,但我不得不說我們非常投入,我們非常專注於交付我們的管道,這確實是我們的首要任務。

  • And we'll doing nothing that would distract us from this, because we are at a very important turning point.

    我們不會做任何會分散我們注意力的事情,因為我們正處於一個非常重要的轉折點。

  • I mean, look at Tagrisso again, I don't want to be repetitive, but I mean, this agent is so exciting.

    我的意思是,再看看 Tagrisso,我不想重複,但我的意思是,這個代理人太令人興奮了。

  • The [IOIO] studies, we can't share data because those are commercially sensitive data, of course, but in terms of recruitment.

    [IOIO] 研究表明,我們不能共享數據,因為這些數據當然是商業敏感數據,但在招聘方面。

  • But the recruitment of these studies is going gang busters, it's really going very well, and we really want to stay very focused on turning this into a reality.

    但是,這些研究的招募工作進展順利,進展非常順利,我們真的希望非常專注於將其變為現實。

  • The other question on R&D productivity, as MedImmune there is no intent to change the model at all.

    另一個關於研發生產力的問題,因為 MedImmune 根本沒有改變模型的意圖。

  • We think we have a great model, there is no perfect model, of course, and a model is usually a function of what you think, what you believe in, but also what is right for your organization.

    我們認為我們有一個偉大的模型,當然沒有完美的模型,模型通常取決於你的想法、你的信仰,以及適合你的組織的東西。

  • And so different companies will come up with different responses, depending on their own culture, their own people, their own history, and a variety of other things.

    因此,不同的公司會根據自己的文化、自己的員工、自己的歷史以及各種其他因素做出不同的回應。

  • But that model we think works for us, and I guess, hopefully the pipeline is here to support that statement.

    但我們認為該模型對我們有用,我想,希望管道在這裡支持該聲明。

  • So there's no intent to change that.

    所以沒有改變它的意圖。

  • Now the question about changing, losing a few people, it's really -- first of all we've lost a couple of people, and they were certainly regretted losses because they were good people, but they got great jobs.

    現在關於改變、失去一些人的問題,真的——首先我們失去了一些人,他們當然對損失感到遺憾,因為他們是好人,但他們找到了很好的工作。

  • And I'm a believer that people have to of course grow and develop and so, I'm disappointed on one hand but on the other hand happy for people when they take a great job.

    而且我相信人們當然必須成長和發展,所以,一方面我很失望,但另一方面我為人們找到一份好工作感到高興。

  • Now it also shows that we have great people, and it also shows that other companies are looking at our people, so it's really a great reflection of the strength of our organization, the strength of our people.

    現在它也表明我們擁有優秀的人才,也表明其他公司正在關注我們的員工,所以這確實很好地反映了我們組織的實力,我們員工的實力。

  • And a final comment I would make here, is that we talk about people departing, we would never talk about people joining us, and I can tell you, we've had like so many great people joining us; and I've one sitting next to me on my left, and our new CMO, and we're so happy to have him on board (laughter), but we have had also many other tremendous talented people joining us.

    我要在這裡做的最後一點評論是,我們談論的是離開的人,我們永遠不會談論加入我們的人,我可以告訴你,我們有很多偉大的人加入我們;我的左邊坐在我旁邊,是我們的新 CMO,我們很高興他加入我們(笑聲),但我們也有許多其他非常有才華的人加入我們。

  • So always sort of sorry to see someone good leaving, even though you are happy for them to see their career develop, and on the other hand we welcome new people and we always look, try to recruit very talented individuals who will strengthen our organization.

    所以看到有人離開總是有點遺憾,儘管你很高興他們看到他們的職業發展,另一方面我們歡迎新人,我們總是在尋找,嘗試招募非常有才華的人來加強我們的組織。

  • So I think that maybe covers this, and we'll move to Nicolas Guyon at Morgan Stanley.

    所以我認為這可能涵蓋了這一點,我們將轉向摩根士丹利的 Nicolas Guyon。

  • Nicolas, go ahead.

    尼古拉斯,繼續。

  • - Analyst

    - Analyst

  • Thanks for taking my questions.

    感謝您回答我的問題。

  • I have three actually.

    其實我有三個。

  • The first one is on SG&A spending and the volatility in the last three years.

    第一個是關於 SG&A 支出和過去三年的波動。

  • You increased SG&A by more than $1 billion in 2014, and you reduced it by about $2 billion last year, with other cuts to come in 2016 and 2017.

    您在 2014 年將 SG&A 增加了超過 10 億美元,去年減少了約 20 億美元,2016 年和 2017 年還將進行其他削減。

  • Not sure I really understand what makes your promotional standing so easy to switch on and off.

    不確定我是否真的理解是什麼讓您的促銷地位如此容易打開和關閉。

  • And isn't there any risk to under invest behind your brands, [whether it be] with all the new launchings that you have?

    對你的品牌進行投資不足的風險是否存在,[無論是]你擁有的所有新產品?

  • Second, on saxa/dapa in the US, correct me if I'm wrong, but it seems to me that you only communicate on filing when they have been accepted.

    其次,在美國的 saxa/dapa 上,如果我錯了請糾正我,但在我看來,您只在申請被接受後才進行交流。

  • So could you please confirm that you have not yet filed Saxa/dapa in the US?

    那麼您能否確認您尚未在美國提交 Saxa/dapa?

  • And finally on MYSTIC, I'm sorry to come back, just a clarification on Sean's previous comment, you do expect PFS data in H1 2017, but do you also expect OS data in 2017?

    最後關於 MYSTIC,我很抱歉回來,只是澄清一下 Sean 之前的評論,您確實期望 2017 年上半年的 PFS 數據,但您是否也期望 2017 年的 OS 數據?

  • Thank you.

    謝謝你。

  • - CEO

    - CEO

  • Thanks Nicolas, so where do we start, Saxa/dapa and MYSTIC, Sean, you want to cover that?

    謝謝尼古拉斯,那麼我們從哪裡開始,Saxa/dapa 和 MYSTIC,肖恩,你想介紹一下嗎?

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • Sure, I can come that, yes.

    當然,我可以來,是的。

  • All I'll do for you with Saxa/dapa is confirm for you that we confirm filing when the filing is accepted.

    我將為 Saxa/dapa 為您做的就是為您確認我們在提交被接受時確認提交。

  • And we haven't mentioned it because the filing has not yet been accepted.

    我們沒有提到它,因為申請尚未被接受。

  • With regard to MYSTIC PFS data, first half of 2017, that is correct.

    關於 2017 年上半年的 MYSTIC PFS 數據,這是正確的。

  • Obviously, these analyses are event driven, and in first-line non-small cell lung cancer, the survival events or deaths are considerably delayed from progressions.

    顯然,這些分析是事件驅動的,在一線非小細胞肺癌中,生存事件或死亡因進展而大大延遲。

  • So it will be further out before we have overall survival data.

    因此,在我們獲得總體生存數據之前,它會更遠。

  • There will be some events but it will not be mature or powered in the first half of 2017.

    2017年上半年會有一些事件,但不會成熟或上電。

  • - CEO

    - CEO

  • Thanks, Sean.

    謝謝,肖恩。

  • So the SG&A question.

    所以 SG&A 問題。

  • You've got to think about what has happened over the last couple of years, Nicolas.

    你必須考慮過去幾年發生的事情,尼古拉斯。

  • First of all, we acquired the BMS half of the diabetes franchise.

    首先,我們收購了 BMS 一半的糖尿病特許經營權。

  • Secondly, we acquired the Almirall portfolio of products.

    其次,我們收購了 Almirall 產品組合。

  • And each time we welcome new people with us, and so that drove suddenly an increase.

    每次我們都歡迎新朋友,所以突然增加了。

  • And each time we decided to focus the organization to keep them focused on the launch of those new products and the promotion of them, and we didn't want to disrupt the sales force, initially, but we always said that over time we would gain productivity improvements across this entire commercial organization.

    每次我們決定讓組織集中註意力,讓他們專注於新產品的發布和推廣,我們最初不想打亂銷售隊伍,但我們總是說,隨著時間的推移,我們會獲得整個商業組織的生產力提高。

  • This is basically what we are doing now.

    這基本上就是我們現在正在做的。

  • So we always sort of, fine tune it so that we remain competitive, but certainly we are looking for improvement across the entire commercial organization, so we can redeploy resources and invest more in oncology; but at the same time of course protect our profitability and the delivery of our dividend which is an important part of our commitment.

    所以我們總是對它進行微調,以保持競爭力,但我們當然正在尋求整個商業組織的改進,這樣我們就可以重新部署資源並在腫瘤學上投入更多;但同時當然要保護我們的盈利能力和派發股息,這是我們承諾的重要組成部分。

  • So we maybe could move to Matt Weston of Credit Suisse.

    所以我們也許可以轉向瑞士信貸的馬特韋斯頓。

  • Matt, go ahead.

    馬特,繼續。

  • - Analyst

    - Analyst

  • Thank you for take my questions, three, if I can.

    謝謝你回答我的問題,三個,如果可以的話。

  • The first on the new focus on SG&A costs.

    首先是對 SG&A 成本的新關注。

  • It is a topic that management has been talking about for some time.

    這是管理層討論了一段時間的話題。

  • And if I look at consensus estimates there's already a substantial saving in SG&A baked into consensus assumptions.

    而且,如果我看一下共識估計,就會發現 SG&A 已經大量節省到共識假設中。

  • Can I just check, are you indicating that this is the way, this is the strategy with which management is actually going to deliver something that's been talked about for some time, or are you indicating that there's an incremental $1 billion on top of what consensus already has baked in, that we should consider from a cost base?

    我可以檢查一下,你是否表示這是管理層實際要交付的東西的方式,這是已經討論了一段時間的策略,或者你是否表示在達成共識的基礎上增加了 10 億美元已經烤熟了,我們應該從成本基礎上考慮?

  • Secondly, clearly strong success in China.

    其次,在中國顯然取得了巨大的成功。

  • A number of your competitors are highlighting a risk in the second half of the year as reimbursement for some drugs goes from federal to provincial governments.

    您的許多競爭對手都強調了今年下半年的一個風險,因為某些藥物的報銷將從聯邦政府轉移到省級政府。

  • How do you feel about that, given it's such a substantial business to you?

    鑑於這對您來說是一項如此重要的業務,您對此有何看法?

  • And then finally on MYSTIC.

    最後是 MYSTIC。

  • Sean, I assume you're going to be relying on the contribution of components pathway to file the combo if neither of the drugs has received accelerated approval before the MYSTIC results are out.

    肖恩,如果在 MYSTIC 結果出來之前兩種藥物都沒有獲得加速批准,我假設你將依靠組件途徑的貢獻來提交組合。

  • Have you actually had interactions with the regulator that suggest this is acceptable; because by my read of the rules, you could argue -- and particularly given that you're doing treme mono arms in a number of other studies -- you could argue you really should have treme mono arm in MYSTIC, if you're relying on it for the approval of two novel drugs simultaneously.

    您是否真的與監管機構進行過互動,表明這是可以接受的?因為根據我對規則的閱讀,你可能會爭辯——特別是考慮到你在許多其他研究中都在做 treme mono arm——你可能會爭辯說你真的應該在 MYSTIC 中擁有 treme mono arm,如果你依賴同時批准兩種新藥。

  • I'd love your feedback on that.

    我希望得到你的反饋。

  • - CEO

    - CEO

  • Matt, I can cover first question.

    馬特,我可以回答第一個問題。

  • The SG&A essentially it is the implementation of the commitments we made that we will reduce SG&A over time starting this year, and Q1 is showing that, and we'll continue reducing SG&A over the next couple of years.

    SG&A 本質上是我們承諾的實施,即我們將從今年開始隨著時間的推移減少 SG&A,Q1 表明了這一點,我們將在未來幾年繼續減少 SG&A。

  • And essentially it's reflecting the shift of our pipeline or portfolio to a more balanced specialty care/primary care, and then we are redeploying our resources and our efforts to this future portfolio.

    從本質上講,它反映了我們的管道或產品組合向更平衡的專業護理/初級護理的轉變,然後我們正在將我們的資源和我們的努力重新部署到這個未來的產品組合中。

  • Now as to your specific question relating to 2017 and whether it's additional to the consensus forecast, I will not answer this because if I did I will give you a guidance for 2017 which we haven't done.

    現在關於你關於 2017 年的具體問題以及它是否是共識預測的補充,我不會回答這個問題,因為如果我回答了,我會給你 2017 年的指導,而我們還沒有這樣做。

  • So I'm sorry I cannot answer it but we certainly will give you our guidance for 2017 in the early phase of 2017 as we always do.

    所以很抱歉我無法回答這個問題,但我們肯定會像往常一樣在 2017 年初為您提供 2017 年的指導。

  • Suffice to say we just kind of continue doing what we said we would do.

    可以說我們只是繼續做我們說過會做的事情。

  • We said we would reduce SG&A, we're doing this.

    我們說我們會減少 SG&A,我們正在這樣做。

  • We said we'd build a pipeline, we're doing this.

    我們說我們會建立一條管道,我們正在這樣做。

  • And essentially, despite quite a number of skeptics, we continue doing what we said we would do.

    從本質上講,儘管有很多人持懷疑態度,但我們仍在繼續做我們說過會做的事情。

  • And we are continuing to prepare to bridge to 2018.

    我們正在繼續準備迎接 2018 年。

  • And maybe one point about 2018 is, to think about how the pipeline is shifting to the specialty care and the addition of the acquisitions we made last year.

    也許關於 2018 年的一點是,考慮管道如何轉向專業護理以及增加我們去年進行的收購。

  • You should consider this and think that as we kind of rebalance, we should have a leveraged growth in 2018 and beyond, and therefore quite a profitable growth actually because of the change in the shape of our pipeline.

    你應該考慮這一點,並認為當我們進行某種再平衡時,我們應該在 2018 年及以後實現槓桿增長,因此實際上由於我們管道形狀的變化而實現相當可觀的盈利增長。

  • As far as China, maybe Luke, you want to add something here?

    至於中國,也許盧克,你想在這裡補充一些東西嗎?

  • But we believe we continue to grow very rapidly in China, and we continue to believe we can [add test] the market growth in China.

    但我們相信我們在中國繼續快速增長,我們繼續相信我們可以 [增加測試] 中國市場的增長。

  • I just want to highlight we believe we have critical mass in China.

    我只想強調,我們相信我們在中國擁有臨界質量。

  • It's really an important point, and we have a tremendous team, and we think it is going to be a tremendous business for us in the years to come.

    這真的很重要,我們擁有一支強大的團隊,我們認為在未來幾年這對我們來說將是一項巨大的業務。

  • Today we are relying on the portfolio we have, which is really exactly what the Chinese patients need today, cardiovascular, diabetes -- I mean diabetes, everybody talks about diabetes being a difficult market in the US and it's true.

    今天,我們依靠我們擁有的產品組合,這正是中國患者今天所需要的,心血管、糖尿病——我的意思是糖尿病,每個人都在談論糖尿病在美國是一個困難的市場,這是事實。

  • But we need to keep in mind, it is a really important growth driver for emerging market businesses, in particular in China, it's going to have an important part to play.

    但我們需要記住,它是新興市場企業的一個非常重要的增長動力,特別是在中國,它將發揮重要作用。

  • So that's where we're focused on today, but also we're starting to prepare the launch of our new oncology drugs, in particular Tagrisso.

    這就是我們今天關注的重點,但我們也開始準備推出我們的新腫瘤藥物,特別是 Tagrisso。

  • Luke, you have anything you want to add?

    盧克,你有什麼要補充的嗎?

  • - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

    - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

  • We have a third of the patients on DPP4s in China, and if you look at Brilinta alone it's not reimbursed and we only have 1%, and not all of our portfolio is exposed to reimbursement.

    在中國,我們有三分之一的患者使用 DPP4,如果你單獨看 Brilinta,它是沒有報銷的,我們只有 1%,而且並非我們所有的產品組合都可以報銷。

  • So, I agree.

    所以,我同意。

  • - CEO

    - CEO

  • Brilinta is not even reimbursed yet in China, we're doing tremendously well already in the first few months.

    Brilinta 在中國甚至還沒有報銷,我們在頭幾個月已經做得非常好。

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • Yes, the contribution of components.

    是的,組件的貢獻。

  • So, I guess the simple answer to the question is that we are confident in our strategy around contribution of components, in particular the data we will have for tremelimumab, and that is based on interaction with regulators.

    所以,我想這個問題的簡單答案是,我們對我們圍繞組件貢獻的戰略充滿信心,特別是我們將擁有的 tremelimumab 數據,這是基於與監管機構的互動。

  • So the fact that, that doesn't occur in the same trial within MYSTIC, we do not view as a challenge.

    因此,在 MYSTIC 的同一試驗中不會發生這種情況,我們不認為這是一個挑戰。

  • - CEO

    - CEO

  • Thanks, Sean.

    謝謝,肖恩。

  • Richard Parkes at Deutsche Bank.

    德意志銀行的理查德帕克斯。

  • Richard, go ahead.

    理查德,繼續。

  • - Analyst

    - Analyst

  • Thanks for take my questions.

    謝謝你回答我的問題。

  • Firstly on Saxa/dapa, obviously you've had the update for the heart failure signal in the Saxagliptin label, and I'm assuming you're likely to have that also in the Saxa/dapa label.

    首先在 Saxa/dapa 上,很明顯你已經在 Saxagliptin 標籤中更新了心力衰竭信號,我假設你也可能在 Saxa/dapa 標籤中有更新。

  • I know there was expiration of the potential mechanism for that ongoing, so I wondered if you could update us on that work, on whether that label is likely to impact your expectations for the Saxa/dapa product?

    我知道正在進行的潛在機制已經過期,所以我想知道你是否可以向我們更新這項工作,關於該標籤是否可能影響你對 Saxa/dapa 產品的期望?

  • Secondly, just a couple of products ones, really.

    其次,真的只是幾個產品。

  • Bydureon in the US is flattening, just wondered if you could update us on any plans that you've got that might help to reinvigorate that.

    美國的 Bydureon 正在趨於平緩,只是想知道您是否可以向我們介紹您制定的任何可能有助於重振它的計劃。

  • I know that you've been working on some different pens in development, devices?

    我知道你一直在開發一些不同的筆,設備?

  • And then finally on ZS-9, I wondered if you could update us on your interactions with the FDA and how confident you are about achieving a label without disadvantage in terms of drug interactions?

    最後關於 ZS-9,我想知道您是否可以向我們更新您與 FDA 的互動情況,以及您對獲得在藥物相互作用方面沒有劣勢的標籤有多大信心?

  • Thanks.

    謝謝。

  • - CEO

    - CEO

  • Thanks, Richard.

    謝謝,理查德。

  • Should we start with Bydureon, Luke, and then Sean, if you could cover ZS-9 US and also the Saxa/dapa label question?

    如果您可以涵蓋 ZS-9 US 以及 Saxa/dapa 標籤問題,我們是否應該從 Bydureon、Luke 和 Sean 開始?

  • - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

    - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

  • Yes, you're right, it is very competitive.

    是的,你沒看錯,競爭非常激烈。

  • We're holding share, we've got a very focused effort.

    我們持有份額,我們有一個非常集中的努力。

  • And it's interesting, there is a pool of physicians that have a lot of confidence in Bydureon, very favorable towards the pen, and you can see that in the numbers.

    有趣的是,有一群醫生對 Bydureon 非常有信心,對筆非常滿意,你可以從數字中看出這一點。

  • I think it continues to be, it's a very attractive area to operate in, and I think the recent outcome studies just reinforce that.

    我認為它仍然是,這是一個非常有吸引力的運營領域,我認為最近的結果研究只是加強了這一點。

  • Many of us who have been following this class for a long time, I think a couple years ago, if you had to pick a class that would have a positive outcome study, then the GLP-1s were the one that you would put at the top of the list, and I think again, recent news, we've now got two outcome studies which are favorable for the class; we have ours ongoing.

    我們中的許多人已經學習這門課很長時間了,我想幾年前,如果你必須選擇一門能夠產生積極結果研究的課程,那麼 GLP-1 就是你會放在最重要的是,我再次想到,最近的新聞,我們現在有兩個對班級有利的結果研究;我們正在進行中。

  • In terms of life cycle, we have a number of things that we're looking at that we'll update you on in the future.

    在生命週期方面,我們正在研究許多事情,我們會在未來為您更新。

  • If we look outside the US, and I think sometimes we forget that, particularly with the diabetes portfolio, we are really in good shape in Europe, as well as emerging markets with Bydureon, Onglyza, and also Farxiga.

    如果我們看看美國以外的地區,我想有時我們會忘記這一點,尤其是在糖尿病產品組合方面,我們在歐洲以及新興市場的 Bydureon 、 Onglyza 和 Farxiga 都處於良好狀態。

  • - CEO

    - CEO

  • Thanks, Luke.

    謝謝,盧克。

  • So Sean, ZS-9, the question was about the FDA interaction.

    肖恩,ZS-9,問題是關於 FDA 的互動。

  • And then Richard, apologies but the Saxa/dapa we were not so sure we got the question, so if you don't mind we'll ask you to repeat it.

    然後是 Richard,抱歉,我們對 Saxa/dapa 不太確定我們是否回答了這個問題,所以如果你不介意,我們會請你重複一遍。

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • I'll do ZS-9 and then we'll try to get a clarification.

    我將執行 ZS-9,然後我們將嘗試進行澄清。

  • So the answer to the ZS-9 is the PDUFA date as we have communicated is 26th of May.

    因此,ZS-9 的答案是 PDUFA 日期,正如我們所傳達的那樣,日期是 5 月 26 日。

  • And we have had relatively typical interaction to date with regard to approaching that PDUFA date, and obviously when we have more definitive, we'll communicate it.

    迄今為止,我們在接近 PDUFA 日期方面進行了相對典型的互動,顯然,當我們有更明確的日期時,我們會進行溝通。

  • But that's all we have right now.

    但這就是我們現在所擁有的。

  • And then again as Pascal said, if you could clarify a little bit what you're looking for clarification around Saxa/dapa.

    然後又像 Pascal 所說的那樣,如果你能稍微澄清一下你正在尋找關於 Saxa/dapa 的澄清。

  • - Analyst

    - Analyst

  • Yes, on Saxa/dapa, basically two components.

    是的,在 Saxa/dapa 上,基本上是兩個組件。

  • Firstly what impact that label update has on your expectations for the combination product, and then secondly it's obviously still not 100% clear whether that heart failure signal is a drug-specific or a class-specific effect.

    首先,標籤更新對您對組合產品的期望有何影響,其次,顯然仍不是 100% 清楚心力衰竭信號是藥物特異性還是類特異性效應。

  • And I know that there's been some work exploring the mechanism there, so just wondering if there's anything that might come out of that, that might help delineate whether it is a Saxa-specific or a class-specific issue.

    而且我知道已經有一些工作探索那裡的機制,所以只是想知道是否有任何可能產生的結果,這可能有助於描述它是特定於 Saxa 的問題還是特定於類的問題。

  • - CEO

    - CEO

  • Okay, that's clear, Richard, so there are two parts to your question.

    好的,理查德,這很清楚,所以你的問題分為兩個部分。

  • One part is for you, Sean, which is heart failure, and do we do anything to understand that better with Onglyza.

    一部分是給你的,肖恩,這是心力衰竭,我們可以做些什麼來更好地理解 Onglyza。

  • Here I would just say that, Richard, our focus now is really very much on Farxiga and Bydureon.

    在這裡我只想說,理查德,我們現在的重點實際上非常集中在 Farxiga 和 Bydureon 上。

  • And then the next is impact on expectations, Luke, it's probably for you.

    接下來是對預期的影響,盧克,這可能適合你。

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • We are looking at data to try and investigate DPP-4 and heart failure.

    我們正在查看數據以嘗試調查 DPP-4 和心力衰竭。

  • There's not much I can communicate until we actually have the data and see what we find.

    在我們真正擁有數據並查看發現的內容之前,我無法交流太多。

  • We do think that the label updates are class label updates, so not specific to particular agents in the classes.

    我們確實認為標籤更新是類標籤更新,因此不特定於類中的特定代理。

  • And so, I'll let Luke talk about the impact.

    所以,我會讓盧克談談影響。

  • - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

    - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

  • It's interesting, I think, Glyxambi sold around 100 million, so it's not insignificant, there's clearly a need.

    有趣的是,我認為 Glyxambi 的銷量約為 1 億,所以它不是微不足道的,顯然有需求。

  • If we look at the combinations that we have with metformin, it's a sizable part of our business.

    如果我們看看我們與二甲雙胍的組合,它是我們業務的很大一部分。

  • I think we also need to balance that with exactly what you've commented on, which is the presence of Onglyza in a combination, so I think it's hard to say at this point.

    我認為我們還需要平衡這一點與您所評論的內容,即 Onglyza 的組合存在,所以我認為目前很難說。

  • We need to look at the ultimate label that we get.

    我們需要看看我們得到的最終標籤。

  • Feeding into that as well, if we look at the portfolio level, I think the outcome study, EMPA-REG, and hopefully we have some positive news ourselves in the future on this.

    考慮到這一點,如果我們看看投資組合層面,我認為結果研究,EMPA-REG,希望我們自己在未來有一些積極的消息。

  • Has raised expectations for the SGLT-2 class in the medium to long-term, and clearly we're a competitive participant there.

    在中長期內提高了對 SGLT-2 類的期望,顯然我們是那裡的競爭參與者。

  • And then, also again, if I look at the overall diabetes portfolio it just reinforce that we've got more positive news for GLP-1s right now, and again we're competitive in that segment.

    然後,再一次,如果我看一下整個糖尿病產品組合,它只會加強我們現在有更多關於 GLP-1 的積極消息,而且我們在該領域再次具有競爭力。

  • So it is like anything in R&D, it's puts and takes, and we just need to see what label we get with Saxa/dapa.

    所以它就像研發中的任何東西一樣,它有放有放,我們只需要看看我們用 Saxa/dapa 得到了什麼標籤。

  • - CEO

    - CEO

  • Thanks, Luke.

    謝謝,盧克。

  • Seamus Fernandez at Leerink.

    Leerink 的 Seamus Fernandez。

  • Seamus, go ahead.

    西默斯,繼續。

  • - Analyst

    - Analyst

  • Thanks can you hear me?

    謝謝你能聽到我嗎?

  • Okay, great.

    好,太棒了。

  • Appreciate the opportunity for the questions.

    珍惜提問的機會。

  • Just a few here.

    這裡只有幾個。

  • First off, can you talk a little bit about your continued emphasis of the $45 billion target and progressing towards it.

    首先,你能談談你對 450 億美元目標的持續強調以及朝著這個目標取得的進展嗎?

  • It just seems in the context of slow primary care launches and some of the dynamics there that, that almost works against the goal of the business, which seems to be shifting much more towards the specialty space and an opportunity towards much greater profitability.

    在初級保健啟動緩慢和那裡的一些動態的背景下,這似乎與企業的目標背道而馳,它似乎正在更多地轉向專業領域,並有機會獲得更大的盈利能力。

  • So just wondering why you guys haven't moved away from that, particularly as greater externalization continues.

    所以只是想知道為什麼你們還沒有擺脫這一點,特別是隨著更大的外部化繼續進行。

  • Second question is on the opportunity for Lynparza.

    第二個問題是關於 Lynparza 的機會。

  • Historically you guys have talked about Lynparza in the PARP class as a $1 billion sort of blockbuster opportunity.

    從歷史上看,你們在 PARP 類中將 Lynparza 視為一個價值 10 億美元的重磅炸彈機會。

  • How has that been evolving, particularly in the context of the information that you're gaining from the IO combinations and also from studies like TOPARP?

    這是如何發展的,特別是在您從 IO 組合以及 TOPARP 等研究中獲得的信息的背景下?

  • And then my last question, really is just a clarification or just trying to get a better understanding.

    然後我的最後一個問題,真的只是一個澄清或只是試圖獲得更好的理解。

  • Sean, you specifically said that you increased the size of the study, of the MYSTIC study, to capture the benefits of overall survival.

    肖恩,你特別說過你增加了 MYSTIC 研究的研究規模,以獲取總體生存的好處。

  • I'm a little confused by that, because I would think that the need to power up the study would be more for PFS, rather than overall survival; because it seems like smaller studies with immuno-oncology products tend to need to be run longer rather than be larger.

    我對此有點困惑,因為我認為加強研究的必要性更多是為了 PFS,而不是總體生存;因為看起來免疫腫瘤學產品的小型研究往往需要運行更長時間而不是更大。

  • So I'm just trying to get a better understanding of that comment.

    所以我只是想更好地理解該評論。

  • Thanks.

    謝謝。

  • - CEO

    - CEO

  • So a few good questions here.

    所以這裡有幾個很好的問題。

  • MYSTIC, Sean, if you want to cover this, and as you speak, the Lynparza question, I think there are two parts, really, in it.

    MYSTIC,肖恩,如果你想討論這個問題,正如你所說,Lynparza 問題,我認為它實際上有兩個部分。

  • I think it would be good if you could share some the work you're doing and some of the [IDs] we have in data in Lynparza, lifecycle management, also combinations in the DDR franchise.

    我認為如果你能分享你正在做的一些工作和我們在 Lynparza 數據中的一些[IDs],生命週期管理,以及 DDR 特許經營中的組合,那會很好。

  • And then maybe Luke, you could talk about the potential of all of that.

    然後也許盧克,你可以談談所有這些的潛力。

  • And then, I'll cover the $45 billion general question later on.

    然後,我將在稍後討論 450 億美元的一般性問題。

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • Sure, well let's MYSTIC first.

    當然,讓我們先來 MYSTIC。

  • Yes, so the issue overall survival is, to your point, a trade-off between time and power.

    是的,所以在您看來,總體生存問題是時間和力量之間的權衡。

  • So it's an event driven trial, so you do the analysis based on the number of events you need.

    所以這是一個事件驅動的試驗,所以你可以根據你需要的事件數量進行分析。

  • The issue about the size of the trial is obviously if you have more patients, you get to the number more quickly.

    關於試驗規模的問題顯然是,如果你有更多的病人,你就能更快地得到這個數字。

  • So we have taken advantage of our robust enrollment to make the trial larger, and to also be able to accumulate those events in a way that we can keep our PFS endpoint in the first half of 2017.

    因此,我們利用我們強大的註冊人數來擴大試驗範圍,並且還能夠以我們可以在 2017 年上半年保持 PFS 終點的方式積累這些事件。

  • The other part of it is you have to power for both primary end points.

    另一部分是你必須為兩個主要終點提供動力。

  • So as I said, we elevated overall survival to a co-primary.

    因此,正如我所說,我們將總體生存率提高到了共同主要水平。

  • When you do that, you then have to power for both endpoints, and so when you make two primary endpoints you do have to make a larger trial.

    當你這樣做時,你必須為兩個端點供電,所以當你製作兩個主要端點時,你必須進行更大規模的試驗。

  • Not so much that, that it is overall survival, but that we moved overall survival to a primary endpoint.

    與其說是總體生存,不如說我們將總體生存轉移到主要終點。

  • So I hope that answers that.

    所以我希望能回答這個問題。

  • With regard to Lynparza, we've started in sort of the purest, easiest to define patient population, which is the BRCA mutant patient population.

    關於 Lynparza,我們從最純粹、最容易定義的患者群體開始,即 BRCA 突變患者群體。

  • But as we've said many times, there are multiple ways that DNA damage repair defects can sensitize to PARP inhibition.

    但正如我們多次說過的那樣,DNA 損傷修復缺陷可以通過多種方式對 PARP 抑制敏感。

  • And I think the data from here in UK, from the Royal Marsden, in prostate cancer really illustrates this, because what was done there was to select patients based on a panel of different mutations and defects that can lead to DNA damage repair problems; and the data has been quite interesting.

    我認為來自英國皇家馬斯登醫院的前列腺癌數據確實說明了這一點,因為那裡所做的是根據一組可能導致 DNA 損傷修復問題的不同突變和缺陷來選擇患者;數據非常有趣。

  • Led, in fact, to the breakthrough designation that FDA granted us in that indication.

    事實上,導致了 FDA 在該適應症中授予我們的突破性指定。

  • So, we see the potential of Lynparza as being able to expand quite a bit beyond where we've started with BRCA mutation in ovarian cancer.

    因此,我們看到了 Lynparza 的潛力,它能夠在我們開始研究卵巢癌 BRCA 突變的基礎上進行相當多的擴展。

  • And then the other thing I would add, is that we do have a whole portfolio behind that.

    然後我要補充的另一件事是,我們確實有一個完整的投資組合。

  • I mentioned the AZD1775, the WEE1 inhibitor, we're studying these drugs in combination as well.

    我提到了 AZD1775,WEE1 抑製劑,我們也在聯合研究這些藥物。

  • And so we see this as really an extraordinary potential portfolio for the treatment of cancer.

    因此,我們認為這確實是治療癌症的一個非常有潛力的組合。

  • - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

    - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

  • Thanks, Sean, and I would just add, Pascal made this point earlier, some of the R&D that we're redirecting, DNA damage responses, a core component of that we believe we're in the lead.

    謝謝,肖恩,我只想補充一點,帕斯卡早些時候提出了這一點,我們正在重新定向的一些研發,DNA 損傷反應,我們認為我們處於領先地位的核心組成部分。

  • Obviously immuno-oncology has been a focus for the market for some time, but it's something that could emerge if we continue to see the positive trends of data that we observed so far as DNA damage response.

    顯然,一段時間以來,免疫腫瘤學一直是市場關注的焦點,但如果我們繼續看到我們觀察到的 DNA 損傷反應數據的積極趨勢,那麼它可能會出現。

  • If we look specifically at Lynparza, it really directly benefits from a number of things.

    如果我們專門研究 Lynparza,它確實直接受益於很多東西。

  • I think firstly, and we've got data on this at ASCO, it's quite a durable response, and so the number of patients who are persisting is a little bit higher than we originally modeled.

    我認為,首先,我們在 ASCO 獲得了這方面的數據,這是一個相當持久的反應,所以堅持的患者人數比我們最初建模的要多一點。

  • We have gotten the [bolis] and that has now come through, so you can see the scripts around 30 a week from memory in the US.

    我們已經獲得了[bolis]並且現在已經通過了,所以你可以在美國每週看到大約 30 個劇本。

  • So it's relatively stable, but that's in the late-line fourth-line ovarian.

    所以還是比較穩定的,不過那是在後線四線卵巢。

  • But we've also got adjacent populations, so we are starting to see around 11% of patients in prostate, we're also seeing breast, as well as some more patients earlier in ovarian, of course ovarian's a smaller indication.

    但我們也有相鄰的人群,所以我們開始看到大約 11% 的前列腺患者,我們也看到乳腺癌,以及更多早期的卵巢患者,當然卵巢的適應症較小。

  • In the future you've got adjacent populations such as ATM, ATR, and potentially HIR.

    將來你會得到相鄰的種群,例如 ATM、ATR 和潛在的 HIR。

  • So again we need see where we evolve and what the data says, but we're certainly encouraged by the early signs from Lynparza and the level of awareness in the community about it.

    因此,我們再次需要了解我們在哪裡發展以及數據說明了什麼,但我們肯定對 Lynparza 的早期跡像以及社區對此的認識水平感到鼓舞。

  • - CEO

    - CEO

  • Thanks, Luke.

    謝謝,盧克。

  • So the general $45 billion question, Seamus.

    所以一般的 450 億美元問題,Seamus。

  • Maybe the one clarification I would bring to that number, by the way, is that it was at 2013 exchange rate, so who knows what exchange rates, where they will be in 2023.

    順便說一下,也許我要對這個數字做一個澄清,那就是它是按 2013 年的匯率計算的,所以誰知道 2023 年的匯率是多少。

  • But if you calculated that number using [two days, right?] I think you'd be more in the $41 billion range or so.

    但如果你用 [兩天,對嗎?] 來計算這個數字,我認為你會在 410 億美元左右。

  • And that's an important piece to keep in mind.

    這是要記住的重要部分。

  • And in fact, by the way, this is also an important other piece to keep in mind is that these currency movements in the last two years or year and a half, have really put a lot of pressure on our profitability.

    事實上,順便說一句,這也是要記住的另一個重要部分,即過去兩年或一年半的這些貨幣走勢確實給我們的盈利能力帶來了很大壓力。

  • And just as a quick reminder, they cost us about in EPS terms about $1 in EPS term, so if you calculate [IPS] using 2013 rate, you'd be today $1 [booked].

    快速提醒一下,按 EPS 計算,它們使我們損失了大約 1 美元,因此如果您使用 2013 年的費率計算 [IPS],那麼您今天 [預訂] 為 1 美元。

  • So this is kind of the thing we're dealing with today, but looking to 2023 our long-range plan still shows that we will get there, we should get there; and everybody sort of looks at the downside in the plan and of course there are downsides, a plan is always made of upsides and downsides.

    所以這就是我們今天要處理的事情,但展望 2023 年,我們的長期計劃仍然表明我們會到達那裡,我們應該到達那裡;每個人都會看計劃中的缺點,當然也有缺點,計劃總是由優點和缺點組成。

  • And so if you look at some products are doing a little bit less well, and some products we are partnering or divesting, but essentially by the way, what we divest is made of products that we are not really having a big impact on our long-range plan because they were launching in 2020 or beyond.

    因此,如果你看一些產品做得不太好,有些產品我們正在合作或剝離,但基本上順便說一句,我們剝離的是我們對我們長期沒有真正產生重大影響的產品-range 計劃,因為他們將在 2020 年或以後推出。

  • But on the other side, we have upsides.

    但另一方面,我們也有優勢。

  • Tagrisso was a risk-adjusted sales forecast.

    Tagrisso 是經過風險調整後的銷售預測。

  • Lynparza was risk-adjusted.

    Lynparza 進行了風險調整。

  • We didn't necessarily think that Lynparza would have the potential we think it will have now, and of course we have the risk, the potential to some extent, same for Tagrisso.

    我們不一定認為 Lynparza 具有我們現在認為的潛力,當然我們有風險,在某種程度上具有潛力,與 Tagrisso 一樣。

  • So you know, as Luke said a bit earlier, you have puts and takes in the plan, and then there's a number of upsides, a number of downsides.

    所以你知道,正如盧克早些時候所說的那樣,你已經投入並接受了計劃,然後有一些好處,一些缺點。

  • The important piece is that, that growth is likely to be more profitable, as you pointed out yourself, than in the plan we had developed and communicated two years ago, because the shift is -- luckily in a way -- the shift is more oncology, more specialty care, maybe less primary care (inaudible) plan, so more profitable growth.

    重要的是,正如你自己指出的那樣,增長可能比我們兩年前製定和傳達的計劃更有利可圖,因為這種轉變——在某種程度上幸運的是——這種轉變更腫瘤學,更多的專業護理,也許更少的初級保健(聽不清)計劃,因此利潤增長更多。

  • So we're nearly finished, with one last question from Eric Le Berrigaud at Bryan Garnier.

    所以我們快結束了,Bryan Garnier 的 Eric Le Berrigaud 提出了最後一個問題。

  • Eric, go ahead.

    埃里克,繼續。

  • - Analyst

    - Analyst

  • Good afternoon.

    下午好。

  • Three short ones.

    三個短的。

  • First, again on Tagrisso precisely in Japan.

    首先,再次在日本的 Tagrisso 上。

  • It looks like you put a lot of emphasis about the potential of this drug in Japan.

    您似乎非常強調這種藥物在日本的潛力。

  • Could you be perhaps even more precise about how big you see this drug in Japan, including what you think about price versus US, about how the ramp-up may be for this drug in Japan?

    您能否更準確地說明您在日本看到這種藥物的規模有多大,包括您對價格與美國的看法,以及這種藥物在日本的增長情況如何?

  • Second refers to OTC Nexium revenues in Q1 with Pfizer.

    第二個是指 Nexium 第一季度與輝瑞的場外交易收入。

  • Just to be clear about what you call milestone revenue, is that a one off, does that include also royalties, how should we see the specific agreements across the year, and maybe across the years to come?

    只是要清楚你所說的里程碑收入,這是一次性的嗎,這是否也包括特許權使用費,我們應該如何看待全年乃至未來幾年的具體協議?

  • And lastly, a very short one about brodalumab.

    最後,關於 brodalumab 的非常簡短的內容。

  • It looks like you're now expecting the final approval, let's say the launch in 2017.

    看起來您現在正在等待最終批准,比方說 2017 年推出。

  • First, does that mean that there won't be any further milestone from Valeant in 2016, and by the way did you get any reiteration of commitment to the drug from Valeant in the recent past?

    首先,這是否意味著 Valeant 在 2016 年不會有任何進一步的里程碑,順便說一句,最近 Valeant 是否重申了對該藥物的承諾?

  • - CEO

    - CEO

  • Thanks, Eric, so maybe Luke, you could comment on Tagrisso Japan, and Marc, if you could cover the milestone question.

    謝謝,埃里克,也許盧克,你可以評論 Tagrisso Japan 和馬克,如果你能回答里程碑問題。

  • - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

    - EVP, Global Product & Portfolio Strategy, Global Medical Affairs & Corporate Affairs

  • If you look at patient numbers, there's around 8,000 in adjuvant, and there's around 18,000 in Japan in first-line, and then if you look at second-line T790M, this if we apply a mutation rate of mid-60s to 70% around 8,000 patients in Japan.

    如果你看一下患者數量,大約有 8,000 名輔助患者,日本大約有 18,000 名一線患者,然後如果你看一下二線 T790M,如果我們應用 60 年代中期到 70% 左右的突變率日本有 8,000 名患者。

  • So the mutation rate is actually, there's a higher incidence in Japan versus caucasian patients.

    所以突變率實際上是,日本的發病率高於白種人患者。

  • The key thing here though is ultimately if we look beyond second-line -- and again we're referencing the BLOOM data that we're very interested in -- the potential to challenge first-generation TKIs in the first-line in Japan is very encouraging and it's a large opportunity.

    不過,這裡的關鍵是最終如果我們超越二線——我們再次參考我們非常感興趣的 BLOOM 數據——在日本一線挑戰第一代 TKI 的潛力是非常令人鼓舞,這是一個很大的機會。

  • - CFO

    - CFO

  • So the question on the Nexium milestone.

    所以關於 Nexium 里程碑的問題。

  • This is the second milestone that we have received from Pfizer.

    這是我們從輝瑞收到的第二個里程碑。

  • This is the secure sales related milestones.

    這是與安全銷售相關的里程碑。

  • - CEO

    - CEO

  • What I remember is the milestones, they are related to approval dates.

    我記得的是里程碑,它們與批准日期有關。

  • And we go continue to work with Valeant in the US to seek approval.

    我們將繼續與美國的 Valeant 合作以尋求批准。

  • We're also working on approval in Europe, and the payment of that milestone will be of course defined by timing of approval and at this stage, I don't think -- you want to comment on that?

    我們也在努力在歐洲獲得批准,當然,這個里程碑的支付將由批准時間決定,在這個階段,我不認為——你想對此發表評論嗎?

  • - EVP, Global Medicines Development & Chief Medical Officer

    - EVP, Global Medicines Development & Chief Medical Officer

  • What we've done is we've calculated when our filing was accepted and then looked at when the PDUFA date would be, and that's why you have that date there.

    我們所做的是計算我們的申請何時被接受,然後查看 PDUFA 日期,這就是為什麼你在那裡有那個日期。

  • Obviously, it's at the regulator's discretion when they actually act, but the way we do this is perhaps the conservative way, and that is to use the PDUFA date and that's what you're looking at there.

    顯然,監管機構何時實際採取行動由他們自行決定,但我們這樣做的方式可能是保守的方式,那就是使用 PDUFA 日期,這就是你在那裡看到的。

  • Again, when the milestone is triggered depends upon the regulator's actual approval, so we're forecasting 2017, it could happen in 2016.

    同樣,何時觸發里程碑取決於監管機構的實際批准,因此我們預測 2017 年,它可能會在 2016 年發生。

  • - Analyst

    - Analyst

  • The 170 million pre-launch milestones won't drop in 2016.

    1.7 億的預發布里程碑在 2016 年不會下降。

  • - CEO

    - CEO

  • Well, I think you have to judge that for yourself.

    好吧,我認為你必須自己判斷。

  • It will be defined by the approval date, as Sean said, and it's really hard to judge at this stage what that date will be.

    正如肖恩所說,它將由批准日期決定,現階段真的很難判斷那個日期是什麼時候。

  • We've communicated a PDUFA date, and then there's also the question of the timing of the approval in Europe.

    我們已經傳達了 PDUFA 日期,然後還有歐洲批准時間的問題。

  • We don't have at this stage more data to give you an indication one way or another as far as the timing dates.

    在這個階段,我們沒有更多數據可以以某種方式向您提供有關時間日期的指示。

  • We keep working with our partner and also with the regulators to see what's best way to get approval.

    我們一直與我們的合作夥伴以及監管機構合作,以了解獲得批准的最佳方式。

  • We really don't have much more we can share compared to what we told you before.

    與我們之前告訴你的相比,我們真的沒有更多可以分享的了。

  • Good, thank you so much, so maybe we'll close here.

    很好,非常感謝,也許我們會在這裡結束。

  • And again, we'd like to thank you very much for your interest in AstraZeneca, and we'd like to wish you a good day.

    再次,我們非常感謝您對阿斯利康的關注,祝您有美好的一天。

  • Bye-bye.

    再見。