使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good afternoon.
下午好。
Welcome, ladies and gentlemen, to AstraZeneca's presentation, conference call and webcast for investors and analysts.
女士們,先生們,歡迎收看阿斯利康為投資者和分析師舉辦的演講、電話會議和網絡直播。
Before I hand over to Pascal Soriot in the auditorium, I'd like to read the safe harbor statement.
在禮堂交給 Pascal Soriot 之前,我想閱讀安全港聲明。
The company intends to utilize the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995.
公司打算利用 1995 年美國私人證券訴訟改革法案的安全港條款。
Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca.
本次電話會議的參與者可能會就阿斯利康的運營和財務業績做出前瞻性陳述。
By their very nature, forward-looking statements involve risk and uncertainty, and results may differ materially from those expressed or implied by these forward-looking statements.
就其本質而言,前瞻性陳述涉及風險和不確定性,結果可能與這些前瞻性陳述所表達或暗示的結果存在重大差異。
The company undertakes no obligation to update forward-looking statements.
公司不承擔更新前瞻性陳述的義務。
(Operator Instructions) I will now hand you over to Chief Executive Officer at AstraZeneca, Pascal Soriot, as the meeting is about to start.
(操作員說明)現在我將把你交給阿斯利康公司的首席執行官 Pascal Soriot,因為會議即將開始。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Good morning, good afternoon, everybody.
大家早上好,下午好。
Hello, everyone.
大家好。
It's Pascal Soriot, I'm the CEO of AstraZeneca.
我是 Pascal Soriot,我是阿斯利康公司的首席執行官。
Welcome to the full year and the fourth quarter 2019 presentation, our conference call and our webcast for investors and analysts.
歡迎觀看 2019 年全年和第四季度的演示、我們的電話會議以及面向投資者和分析師的網絡廣播。
We are live in London.
我們住在倫敦。
As always, our presentation is available on astrazeneca.com, and we've also sent it to people on our distribution list.
與往常一樣,我們的演示文稿可在 astrazeneca.com 上獲得,我們也已將其發送給我們通訊組列表中的人員。
Please turn to Slide 2. This is the safe harbor statement.
請轉到幻燈片 2。這是安全港聲明。
We'll be making comments on our performance using core financial numbers and at constant exchange rate or CER, which are both non-GAAP measures.
我們將使用核心財務數據和固定匯率或 CER 對我們的業績發表評論,這都是非 GAAP 衡量標準。
We'll also discuss other non-GAAP measures deemed helpful for investors and analysts.
我們還將討論其他被認為對投資者和分析師有幫助的非 GAAP 措施。
For a reconciliation between non-GAAP and GAAP measures, please see the results announcement issued this morning.
有關非 GAAP 和 GAAP 措施之間的調節,請參閱今天上午發布的結果公告。
And finally, all numbers, as always, will refer to million U.S. dollars and growth rates will be at CER and for full year 2019 until -- unless we state otherwise.
最後,所有數字一如既往地指百萬美元,增長率將按 CER 計算,2019 年全年直到——除非我們另有說明。
Please turn to Slide 3. We plan to spend about 40, 45 minutes on the presentation, and we'll stick to our text so that we don't go over the time, so we have enough time for Q&A.
請轉到幻燈片 3。我們計劃在演示文稿上花費大約 40、45 分鐘,我們將堅持我們的文本,這樣我們就不會超時,所以我們有足夠的時間進行問答。
(Operator Instructions) There's also an option to ask questions as part of the webcast.
(操作員說明)作為網絡廣播的一部分,還可以選擇提問。
(Operator Instructions) I know I ask this every time and I'm never successful, but let me try again.
(操作員說明)我知道我每次都問這個,但我從來沒有成功過,但讓我再試一次。
Today, I'm joined by the usual team, Dave Fredrickson, our EVP for Oncology; Ruud Dobber, our EVP for the BioPharmaceutical Business Unit; Marc, our CFO; José Baselga, who is the EVP in charge of Oncology R&D ; and Mene Pangalos, our EVP in charge of BioPharmaceutical R&D.
今天,我們的腫瘤學執行副總裁戴夫·弗雷德里克森 (Dave Fredrickson) 加入了我的常規團隊; Ruud Dobber,我們的生物製藥業務部執行副總裁;馬克,我們的首席財務官; José Baselga,負責腫瘤研發的執行副總裁;和 Mene Pangalos,我們負責生物製藥研發的執行副總裁。
We also have with us from Shanghai, Leon Wang, who is our EVP for the Emerging Markets, including China.
我們還有來自上海的 Leon Wang,他是我們新興市場(包括中國)的執行副總裁。
And we also have other members of the team here in the room to address some of the questions.
我們還有團隊的其他成員在房間裡解決一些問題。
Leon will be with us via video conferencing.
Leon 將通過視頻會議與我們一起。
You can't see him, but I can see him and I will call him in, and you will see him when I call him in if you have questions for him.
你看不到他,但我能看到他,我會把他叫進來,如果你有問題要問他,當我叫他進來時你會看到他。
Please turn to Slide 4. This is the agenda.
請轉到幻燈片 4。這是議程。
And if you don't mind, please turn to Slide 5. So as we enter 2020 and a new decade for AstraZeneca, we remain firmly committed to our strategic priorities from last year.
如果您不介意,請轉到幻燈片 5。因此,在我們進入 2020 年和阿斯利康的新十年之際,我們仍然堅定地致力於我們去年的戰略重點。
We are delivering growth and leadership in the 3 CRP areas that we have chosen to focus on.
我們正在我們選擇關注的 3 個 CRP 領域實現增長和領導。
If you look at the numbers presented today and the continued growth that is in the guidance, we are pleased to be leading roles in oncology, cardiovascular, renal, metabolism and also in respiratory disease.
如果您查看今天提供的數字和指南中的持續增長,我們很高興在腫瘤學、心血管、腎臟、新陳代謝以及呼吸系統疾病方面發揮領導作用。
In the same therapy areas, we've launched a number of new medicines in the year.
在相同的治療領域,我們在這一年推出了許多新藥。
And we also have an extensive pipeline in Phase III, II and in Phase I. We'll talk more about this later today.
我們在第三階段、第二階段和第一階段也有廣泛的管道。我們將在今天晚些時候詳細討論這個問題。
And outside the main therapy areas, we're also advancing technology platforms and our data science.
在主要治療領域之外,我們還在推進技術平台和我們的數據科學。
Finally, and really consistent with our strategy described in 2013, we want to remain a great place to work for our 70,000 colleagues around the world.
最後,與我們在 2013 年描述的戰略完全一致的是,我們希望繼續成為我們全球 70,000 名同事的理想工作場所。
In recent surveys, we continue to improve on this goal.
在最近的調查中,我們繼續改進這個目標。
Lately, I'm very proud to have observed the resilience of our colleagues in China.
最近,我很自豪地觀察到我們中國同事的韌性。
They're doing a fantastic work, and we all are with them supporting them through these challenging times.
他們正在做著出色的工作,我們都與他們一起支持他們度過這些充滿挑戰的時期。
And I'm sure we will be getting through this coronavirus outbreak, and I'm sure you will have a few questions for us.
我相信我們會度過這次冠狀病毒的爆發,我相信你會有幾個問題要問我們。
So if you turn to Slide 6. 2019 really was a milestone for our return to growth.
因此,如果您轉到幻燈片 6。2019 年確實是我們恢復增長的里程碑。
We've delivered 6 consecutive growth -- quarterly growths over the last period of time.
我們已經連續 6 次實現增長——在過去一段時間內實現了季度增長。
And this really allowed us to accelerate our strategic transition with an increasing focus on sales and ongoing collaboration revenue.
這確實使我們能夠通過更加關註銷售和持續合作收入來加速我們的戰略轉型。
For example, core operating income was reduced by 26% in 2019.
例如,2019 年核心營業收入減少了 26%。
So we truly are returning to underlying growth of our core products.
因此,我們真正恢復了核心產品的潛在增長。
Total revenue increased by 13%.
總收入增長了 13%。
Collaboration revenue was down by 20%, including a lower level of option payments from Merck.
協作收入下降了 20%,其中包括來自默克的較低水平的期權付款。
But more revenue from sales milestones as Lynparza became a blockbuster medicine.
但隨著 Lynparza 成為重磅炸彈藥物,銷售里程碑帶來了更多收入。
In the quarter, sales growth moderated to 9%, as we had anticipated and we had told you earlier in the year last year, and we ended up at 15% for the whole year.
本季度,銷售額增長放緩至 9%,正如我們預期的那樣,我們在去年早些時候告訴過你,全年我們最終達到了 15%。
We saw a strong performance across the CRP areas and across individual medicines.
我們看到 CRP 領域和單個藥物的強勁表現。
New medicines grew by 62%, and we added almost $4 billion, actually $3.8 billion precisely, in 2019.
新藥增長了 62%,我們在 2019 年增加了近 40 億美元,實際上是 38 億美元。
The result was driven, as you know, mostly by Oncology, up by 47%, and by the Emerging Markets that we're up by 24%, but every therapy area did well.
如您所知,結果主要是由腫瘤學推動的,增長了 47%,而新興市場增長了 24%,但每個治療領域都表現良好。
During the course of 2019, we saw countries outside China that contributed more to the Emerging Markets, which increased the diversification of our sales performance.
在 2019 年期間,我們看到中國以外的國家對新興市場的貢獻更大,這增加了我們銷售業績的多元化。
In the fourth quarter, Respiratory ended the year on a high note, and we anticipate this to continue in 2020 while Oncology reaches higher penetration rates in some countries like the U.S. and Japan.
第四季度,呼吸科以高調結束了這一年,我們預計這種情況將在 2020 年繼續,而腫瘤科在美國和日本等一些國家的滲透率將達到更高。
This highlights the portfolio benefit of our therapy areas and our diversified strategy across the 3 main tiers.
這突出了我們治療領域的投資組合優勢以及我們在 3 個主要層級的多元化戰略。
Core operating costs increased by 7% as we continue to invest in launches and in the emerging markets in particular.
隨著我們繼續投資於發布,尤其是新興市場,核心運營成本增加了 7%。
We continue to monitor costs while remaining opportunistic and entrepreneurial.
我們繼續監控成本,同時保持機會主義和企業家精神。
As a result, we saw an underlying increase in operating leverage.
因此,我們看到了經營槓桿的潛在增加。
Including the impact of the Epanova inventory write-down of about 2 percentage points, core operating profit increased by 13%.
包括 Epanova 庫存減記約 2 個百分點的影響,核心營業利潤增長 13%。
Core EPS came in at $3.50 with a tax rate of 20%, as we had indicated at the last quarterly results.
正如我們在上一季度業績中指出的那樣,核心每股收益為 3.50 美元,稅率為 20%。
For 2020, as Marc will describe to you, we anticipate another year of strong growth.
對於 2020 年,正如馬克將向您描述的那樣,我們預計又是強勁增長的一年。
However, we also need to take into account the situation with the coronavirus in China.
但是,我們還需要考慮到中國冠狀病毒的情況。
So we anticipate total revenue to increase by high single-digit to a low double-digit percentage.
因此,我們預計總收入將以高個位數增長至低兩位數百分比。
And when it comes to core EPS, we anticipate an increase of mid- to high-teens percentage.
在核心每股收益方面,我們預計中高百分比會增加。
As I mentioned last quarter, 2020 is a transition year.
正如我在上個季度提到的,2020 年是一個過渡年。
We'll continue to invest in our R&D and our pipeline.
我們將繼續投資於我們的研發和管道。
But the organization is also supporting a number of ongoing launches, actually quite a large number of launches.
但該組織也支持一些正在進行的發射,實際上是相當多的發射。
And we're expanding in hematology and renal diseases where we have limited presence -- or have had limited presence until today.
我們正在擴大我們在血液學和腎臟疾病領域的影響力有限——或者直到今天我們的影響力都有限。
After this year, we anticipate a steadier state and we reiterate -- sorry, we reconfirm our commitment to a core operating margin in excess of 30% from 2021.
今年之後,我們預計會出現更穩定的狀態,我們重申——抱歉,我們再次確認從 2021 年起核心營業利潤率超過 30% 的承諾。
We continue to have the ambition of covering the dividend next year and this year also, excluding the payments linked to the Daiichi Sankyo transaction.
我們繼續致力於支付明年和今年的股息,不包括與 Daiichi Sankyo 交易相關的付款。
In short, I would say that all our financials are on track and our goals are unchanged and in line with what we've said in the past, so very much in line with previous communications.
簡而言之,我想說我們所有的財務狀況都在正常軌道上,我們的目標沒有改變,並且與我們過去所說的一致,與之前的溝通非常一致。
Finally, the pipeline delivered an unprecedented level of positive news during 2019, reconfirmed in 2000 -- in the last quarter, as you saw.
最後,管道在 2019 年傳遞了前所未有的積極消息,並在 2000 年再次得到證實——在最後一個季度,如您所見。
This trend, we expect to continue this year and next year based on what we know today and the pipeline update that we will share with you later.
根據我們今天所知道的情況以及我們稍後將與您分享的管道更新,我們預計這一趨勢將在今年和明年繼續下去。
So if you turn to Slide 7. So if you look at the pipeline news flow since the results announcement last October, I'd like to pick only a few highlights.
因此,如果你轉到幻燈片 7。因此,如果你查看自去年 10 月公佈結果以來的管道新聞流,我只想挑出幾個亮點。
For Imfinzi, we moved forward with regulatory interactions for the CASPIAN indication in small cell lung cancer.
對於 Imfinzi,我們推進了小細胞肺癌中 CASPIAN 適應症的監管相互作用。
And as you know, we got priority review in the United States, which reflects the strength of the data.
如您所知,我們在美國獲得了優先審查,這反映了數據的強度。
Lynparza achieved several milestones, including submissions in the U.S. and elsewhere, but importantly, a priority review in the United States for ovarian cancer in combination with Avastin.
Lynparza 實現了幾個里程碑,包括在美國和其他地方的提交,但重要的是,與 Avastin 聯合治療卵巢癌在美國獲得優先審查。
And also, we filed as a monotherapy for prostate cancer.
而且,我們申請作為前列腺癌的單一療法。
Together with our partners, Daiichi Sankyo, we received approval in record time for -- in HER2 -- in third-line HER2-positive breast -- metastatic breast cancer.
我們與我們的合作夥伴 Daiichi Sankyo 一起,在創紀錄的時間內獲得批准用於 HER2 轉移性乳腺癌的三線治療。
And we've also received encouraging data in metastatic gastric cancer, and we're now pursuing regulatory submissions wherever we can.
我們還收到了關於轉移性胃癌的令人鼓舞的數據,我們現在正在盡可能地尋求監管提交。
Calquence won U.S. approval in CLL and is off to a strong launch.
Calquence 在 CLL 中贏得了美國的批准,並且即將推出。
Interestingly, we got approval also in Australia and Canada at the same time for the Orbis process, which reflects not only on the product itself but the great job that our regulatory teams are doing around the world.
有趣的是,我們同時在澳大利亞和加拿大獲得了 Orbis 流程的批准,這不僅反映了產品本身,還反映了我們的監管團隊在世界各地所做的出色工作。
If I move to BioPharmaceuticals, Farxiga made very good regulatory progress in heart failure, including another priority review in the United States, so really very strong data there.
如果我轉向生物製藥,Farxiga 在心力衰竭方面取得了非常好的監管進展,包括在美國的另一項優先審查,所以那裡的數據非常強大。
And we had a U.S. regulatory submission acceptance that -- for roxadustat with our partner, FibroGen, in chronic kidney disease.
我們接受了美國監管機構提交的申請——羅沙司他與我們的合作夥伴 FibroGen 合作治療慢性腎病。
So before I leave the pipeline, I want to extend my thanks, my sincere thanks to all our colleagues around the world, in particular our R&D colleagues globally who came together in 2019 into 2 R&D units, Oncology and BioPharmaceuticals.
因此,在我離開管道之前,我想表達我的謝意,衷心感謝我們在世界各地的所有同事,特別是我們全球的研發同事,他們在 2019 年聚集到兩個研發部門,即腫瘤學和生物製藥。
We should never underestimate the changes or the impact that a change like this has on people's daily life.
我們永遠不應低估這種變化或這種變化對人們日常生活的影響。
And despite this, they delivered this absolutely outstanding result.
儘管如此,他們還是取得了絕對出色的成績。
So we are all very grateful for the continued innovative science and the progress that the team is making for patients.
因此,我們都非常感謝持續的創新科學和團隊為患者取得的進步。
Please turn to Slide 8. So with 15% growth in 2019, 9% in the quarter -- in the last quarter, we closed the year with 6 consecutive quarters of growth.
請轉到幻燈片 8。因此,2019 年增長了 15%,本季度增長了 9%——在上個季度,我們以連續 6 個季度的增長結束了這一年。
We continue to see some variations from quarter-to-quarter.
我們繼續看到季度與季度之間存在一些差異。
Fourth quarter was impacted by an adverse price adjustment in Japan for Tagrisso and also a negative impact of U.S. gross to net adjustment.
第四季度受到日本對 Tagrisso 的不利價格調整以及美國毛淨調整的負面影響。
But also -- but we had continued growth in total prescriptions.
而且——但我們的總處方量持續增長。
On the other hand, Respiratory with Fasenra, Symbicort and Pulmicort delivered a strong finish in 2019, which really bodes well for 2020.
另一方面,Respiratory 與 Fasenra、Symbicort 和 Pulmicort 在 2019 年取得了強勁的成績,這對 2020 年來說確實是個好兆頭。
In CVRM, we saw continued progress for Farxiga and Brilinta.
在 CVRM 中,我們看到了 Farxiga 和 Brilinta 的持續進步。
New medicines continued to make an impact on growth.
新藥繼續對增長產生影響。
As I said earlier, $3.8 billion of incremental sales in 2019 versus '18.
正如我之前所說,與 18 年相比,2019 年的銷售額增加了 38 億美元。
Importantly, as we look forward, we definitely are expecting in the U.S. a slower growth rate for products like Tagrisso and Imfinzi in Stage III lung cancer because we have high penetration.
重要的是,正如我們所期待的那樣,我們肯定預計在美國,Tagrisso 和 Imfinzi 等產品在 III 期肺癌中的增長率會放緩,因為我們的滲透率很高。
But we now will see larger contributions from products like Calquence in CLL, Lokelma in hyperkalemia and from many other launches as well.
但我們現在將看到來自 CLL 中的 Calquence、高鉀血症中的 Lokelma 等產品以及許多其他產品的更大貢獻。
So based on the performance in '19, we now have 9 blockbuster medicines, more or less a doubling over the past few years with Lynparza joining the list after a strong year.
因此,根據 19 年的表現,我們現在有 9 種重磅炸彈藥物,在過去幾年中或多或少翻了一番, Lynparza 在強勁的一年後加入了名單。
And that really drives further diversification of our portfolio and a broad-based growth that should ensure sustainable future growth.
這確實推動了我們投資組合的進一步多元化和基礎廣泛的增長,這將確保未來的可持續增長。
If you look -- if you turn to Slide 9, you will see here the growth -- the sales by TA and by region.
如果你看——如果你轉向幻燈片 9,你會在這裡看到增長——按 TA 和地區劃分的銷售額。
As we discussed in the past, we've achieved a more diversified and a more sustainable top line in the new company.
正如我們過去所討論的那樣,我們在新公司中實現了更加多元化和更具可持續性的收入。
Beyond the broader revenue base from therapy areas and medicines, the geographical spread of the business is really continuing to benefit us.
除了來自治療領域和藥物的更廣泛的收入基礎之外,業務的地理分佈確實繼續使我們受益。
All therapy areas grew by double-digit percentages in 2019.
2019 年,所有治療領域都以兩位數的百分比增長。
And all but New CVRM achieved the same for the fourth quarter.
除了 New CVRM 之外,所有其他公司在第四季度都取得了同樣的成績。
The Emerging Markets had a tremendous 2019 with 24% growth, including 35% in China and 12% in the other emerging markets outside of China.
新興市場在 2019 年表現出色,增長 24%,其中中國增長 35%,中國以外的其他新興市場增長 12%。
This market showed great progress in 2019.
這個市場在 2019 年取得了長足的進步。
And as we manage the situation around the coronavirus, this increased diversification is really truly a plus for our company.
在我們管理冠狀病毒周圍的情況時,這種多樣化的增加對我們公司來說確實是一個優勢。
When we look at the company now, we operate in areas of high unmet need with an opportunity to address serious diseases that impact patients and health care systems around the world.
當我們現在審視這家公司時,我們在需求未得到滿足的領域開展業務,有機會解決影響全球患者和醫療保健系統的嚴重疾病。
From a business viewpoint, we're also in areas with growth opportunities as we improve patient outcomes.
從商業角度來看,隨著我們改善患者的治療效果,我們也處於具有增長機會的領域。
We're even more globally oriented than in the past but also -- through the business, but also through our colleagues and our presence in more than 100 countries around the world and very strong teams in each of those countries.
我們比過去更加全球化,但也通過業務,還通過我們的同事和我們在全球 100 多個國家的業務以及在每個國家的強大團隊。
And as we look ahead, the guidance for 2020 provides confidence for continued expansion.
展望未來,2020 年的指引為繼續擴張提供了信心。
We see really clear opportunities for our late-stage pipeline and our medicines under our registration to strengthen our continued growth.
我們看到了我們後期管道和我們註冊的藥物真正明確的機會,以加強我們的持續增長。
Please turn to Slide 10.
請轉到幻燈片 10。
Before ending my introduction, I wanted to reflect on the good progress we've made on our sustainability journey.
在結束我的介紹之前,我想回顧一下我們在可持續發展之旅中取得的良好進展。
As a sustainable company, our commitment to society, to people in the planet lies at the heart of everything we do.
作為一家可持續發展的公司,我們對社會和地球上的人們的承諾是我們所做一切的核心。
And we believe that climate change is an urgent threat to public health, the environment and the sustainability of the global economy, as you all heard Larry Fink described.
我們相信氣候變化是對公共健康、環境和全球經濟可持續性的緊迫威脅,正如你們都聽到拉里·芬克所描述的那樣。
And many companies, including us, have received letter recently reinforcing that message to us.
包括我們在內的許多公司最近都收到了向我們強調這一信息的信件。
Since 2015, AstraZeneca has reduced our carbon emissions from operations by almost 1/3 and our water consumption by almost 1/5.
自 2015 年以來,阿斯利康已將運營產生的碳排放量減少了近 1/3,耗水量減少了近 1/5。
However, we recognize it is really not enough and we decided to step up our progress towards reducing our carbon footprint.
然而,我們認識到這確實還不夠,我們決定加快我們在減少碳足跡方面的進展。
Pharmaceutical companies, as you can see on this graph, is a relatively carbon-intensive industry and we need to do more.
正如您在這張圖中看到的那樣,製藥公司是一個相對碳密集的行業,我們需要做更多的事情。
We as a company, we as an industry, together with the broader economy, we need to actually do more.
作為一家公司,我們作為一個行業,與更廣泛的經濟一起,我們實際上需要做更多的事情。
At the World Economic Forum in Davos, there was a lot of talk about climate change.
在達沃斯世界經濟論壇上,有很多關於氣候變化的討論。
A lot of companies are really getting engaged in this.
很多公司都真正參與其中。
And we announced our Ambition Zero Carbon strategy to speed up our reduction -- the reduction of our impact on the environment.
我們還宣布了我們的零碳雄心戰略,以加快我們的減排——減少我們對環境的影響。
We want to be carbon zero by 2025 and -- for our own operations and carbon negative by 2030 for the entire value chain.
我們希望到 2025 年實現零碳排放,並且到 2030 年實現整個價值鏈的碳負排放。
Some people say it's a very stretch goal that we may or may not achieve.
有人說這是一個非常艱鉅的目標,我們可能會或可能不會實現。
But as you know, we are used to stretch goals.
但如您所知,我們習慣於設定目標。
And so this is another stretch goal we've given ourselves.
所以這是我們給自己設定的另一個延伸目標。
And we will -- we plan to invest up to $1 billion over the next 10 years to achieve these goals and also, as part of it, develop the next generation of respiratory inhalers powered by propellants with near zero global warming potential.
我們將 - 我們計劃在未來 10 年內投資高達 10 億美元來實現這些目標,並且作為其中的一部分,開發下一代呼吸吸入器,該吸入器由全球變暖潛能值接近零的推進劑提供動力。
So it's really pleasing to see that our efforts to cut emissions, mitigate climate risk and develop this low-carbon economy and sustainable management of resources are being recognized.
因此,很高興看到我們在減排、緩解氣候風險、發展低碳經濟和資源可持續管理方面的努力得到認可。
CDP, a global environmental not profit organization that measures environmental impact, awarded AstraZeneca AA listing.
CDP 是一家衡量環境影響的全球環境非營利組織,授予阿斯利康 AA 名錄。
We are one of just 3 companies worldwide to achieve AA listing for 4 consecutive years.
我們是全球僅有的 3 家連續 4 年實現 AA 上市的公司之一。
Companies cannot solve the issues of public health and the environment by themselves.
公司無法自行解決公共衛生和環境問題。
So there has to be a joint effort with government, companies, nongovernmental organizations to get to a better place and a healthier planet.
因此,必須與政府、公司、非政府組織共同努力,讓地球變得更美好、更健康。
We're committed to playing our part.
我們致力於發揮我們的作用。
We joined the Sustainable Market Council established by the Prince of Wales, and a number of other companies are part of this.
我們加入了由威爾士親王建立的可持續市場委員會,許多其他公司也參與其中。
We launched this at the World Economic Forum, and we're looking forward to making progress through this team.
我們在世界經濟論壇上推出了這個,我們期待通過這個團隊取得進展。
Overall, I'm really proud of the progress we've made in 2019 against our 3 priorities to access -- our 3 priority areas of access to health care, environmental production and ethics and transparency.
總的來說,我為我們在 2019 年取得的 3 個優先訪問領域取得的進展感到非常自豪——我們的 3 個優先領域是獲得醫療保健、環境生產以及道德和透明度。
Thank you so much for your continued interest in our company.
非常感謝您對我們公司的持續關注。
And we'll now -- I will now hand over to Dave, who will cover our Oncology business.
我們現在——我現在將交給戴夫,他將負責我們的腫瘤業務。
So please turn to Slide 11.
所以請轉到幻燈片 11。
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
So Thomas and the IR guys really put a lot of effort into this podium, so I thought that I would use it.
所以托馬斯和 IR 人員真的為這個講台付出了很多努力,所以我認為我會使用它。
It would be a shame to leave it here all by itself.
把它單獨留在這裡太可惜了。
So on Oncology.
所以在腫瘤學上。
As we report on sales for Oncology, we reached sales of $8.7 billion.
當我們報告腫瘤學的銷售額時,我們的銷售額達到了 87 億美元。
And as Pascal said, that was growth of 47%.
正如帕斯卡所說,這是 47% 的增長。
And our 4 new medicines really were the contributors of $2.9 billion of incremental growth for the year.
我們的 4 種新藥確實為當年 29 億美元的增量增長做出了貢獻。
As anticipated, we experienced some softness in the final quarter of the year with our mature portfolio.
正如預期的那樣,我們成熟的投資組合在今年最後一個季度經歷了一些疲軟。
So we had Faslodex and generic competition enter into the United States.
因此,我們讓 Faslodex 和仿製藥競爭進入美國。
We also saw further competition for Iressa and cannibalization across the globe and then some onetime effects, especially within the U.S. and within China, and we can talk more about that later.
我們還看到了易瑞沙在全球範圍內的進一步競爭和蠶食,以及一些一次性的影響,尤其是在美國和中國,我們稍後可以詳細討論。
In the lung cancer franchise, the Tagrisso and Imfinzi launches in the approved indications have progressed as more countries outside of the U.S. have granted approval and reimbursement based upon FLAURA and on PACIFIC.
在肺癌專營權方面,Tagrisso 和 Imfinzi 在批准的適應症中的推出取得了進展,因為美國以外的更多國家已經根據 FLAURA 和 PACIFIC 批准和報銷。
Lynparza continued to cement itself as the leading PARP inhibitor.
Lynparza 繼續鞏固自己作為領先 PARP 抑製劑的地位。
It became a blockbuster in 2019, as Pascal had mentioned.
正如帕斯卡所說,它在 2019 年成為了重磅炸彈。
And we saw more women with first-line ovarian cancer being treated across the globe as we establish a standard of care following on SOLO-1.
隨著我們在 SOLO-1 之後建立護理標準,我們看到更多的一線卵巢癌女性在全球範圍內接受治療。
With our mature medicines, Faslodex had sales of $892 million for the year.
憑藉我們成熟的藥物,Faslodex 當年的銷售額為 8.92 億美元。
This was a decline of 11%, the impact of generics, as I mentioned, really taking hold in the fourth quarter, particularly within the U.S. On the other hand, and I think importantly, we saw growth and strength in Zoladex, really on the heels of emerging markets.
這是 11% 的下降,正如我提到的,仿製藥的影響在第四季度真正發揮作用,特別是在美國。另一方面,我認為重要的是,我們看到了 Zoladex 的增長和實力,實際上是在新興市場的腳跟。
Sales were $813 million for the year, up by 13%.
全年銷售額為 8.13 億美元,增長 13%。
Lastly, on the overview slide, in terms of the new launches, we were incredibly pleased, of course, to launch both Enhertu and Calquence at the tail end of the year.
最後,在概述幻燈片上,就新發布而言,我們當然非常高興在年底推出 Enhertu 和 Calquence。
Calquence is now in the CLL launch within the U.S. And although early days, initial indicators are positive for both Calquence and Enhertu.
Calquence 現在正在美國推出 CLL,儘管初期,初步指標對 Calquence 和 Enhertu 都是積極的。
Enhertu, our new medicine with Daiichi Sankyo, for HER2-positive breast cancer, which was approved at the end of last year and which we then had commercially launched very immediately thereafter.
Enhertu 是我們與 Daiichi Sankyo 合作的用於治療 HER2 陽性乳腺癌的新藥,它於去年年底獲得批准,隨後我們立即將其推向市場。
Please turn to Slide 13.
請轉到幻燈片 13。
So now talking about Tagrisso.
所以現在談論Tagrisso。
It's the company's #1 selling medicine.
這是該公司排名第一的暢銷藥。
Tagrisso demonstrated continued growth in 2019.
Tagrisso 在 2019 年表現出持續增長。
Fueled by the first-line launches, sales were up 74%, reaching $3.2 billion for the year, with $1.3 billion in incremental sales, much of that coming from the U.S., Japan and the second line use within China.
在一線上市的推動下,銷售額增長了 74%,全年達到 32 億美元,銷售額增加了 13 億美元,其中大部分來自美國、日本和中國境內的二線使用。
Out of the 80 first-line approvals though that have been granted to date, only 18 markets have first-line reimbursement, which actually speaks to the opportunities that are ahead of us with Tagrisso in terms of continuing to expand the opportunities with FLAURA to the rest of the globe.
在迄今為止已授予的 80 個一線批准中,只有 18 個市場有一線報銷,這實際上說明了我們在 Tagrisso 面前的機會,繼續將 FLAURA 的機會擴展到全球其他地區。
The U.S. ended to a sales of $1.3 billion in the year, up by 46%.
美國當年的銷售額為 13 億美元,增長了 46%。
Sequential sales were adversely impacted by previously mentioned one-offs in the third quarter of 2019, including inventory build and gross to net adjustments in the fourth quarter, though the underlying demand growth continued as we reached a high level of penetration in the front line at the exit.
連續銷售受到前面提到的 2019 年第三季度一次性的不利影響,包括第四季度的庫存增加和毛淨調整,儘管隨著我們在前線的滲透率達到高水平,潛在需求仍在繼續增長出口。
Europe reported $474 million of sales with a growth of 59% on the heels of the first-line reimbursement decisions across the region.
歐洲報告了 4.74 億美元的銷售額,在該地區的一線報銷決定之後增長了 59%。
In Europe, Tagrisso is now the #1 prescribed tyrosine kinase inhibitor in new patients in the first-line setting.
在歐洲,Tagrisso 現在是一線新患者中排名第一的處方酪氨酸激酶抑製劑。
In Emerging Markets, Tagrisso had $762 million in sales.
在新興市場,Tagrisso 的銷售額為 7.62 億美元。
And as anticipated, China sales in the fourth quarter were impacted by the customary end-of-year destocking that we see in hospitals as they manage their annual funds.
正如預期的那樣,第四季度中國的銷售額受到我們在醫院管理年度資金時看到的慣常年終去庫存的影響。
Nevertheless, underlying demand remained very healthy, and we now have a good level of penetration in the second line indication and as a result of the NRDL inclusion in the second line within China, and we anticipate frontline NRDL this year in 2020.
儘管如此,潛在需求仍然非常健康,我們現在在二線適應症方面的滲透率很高,並且由於 NRDL 被納入中國的二線,我們預計今年將在 2020 年成為一線 NRDL。
Japan had sales of $633 million as quarterly sequential sales growth was impacted by the previously mentioned 15% price reduction that we took in November in the fourth quarter.
日本的銷售額為 6.33 億美元,因為季度連續銷售額增長受到前面提到的我們在第四季度 11 月降價 15% 的影響。
And in 2020, we continue to see significant growth opportunities for Tagrisso with the usual deviations that we'd see quarter-to-quarter.
到 2020 年,我們將繼續看到 Tagrisso 的重大增長機會,但通常會出現季度與季度之間的偏差。
But we're confident that Tagrisso will take another step forward in 2020 as more reimbursements are granted.
但我們相信,隨著更多的報銷獲得批准,Tagrisso 將在 2020 年向前邁出又一步。
Please turn to Slide 14.
請轉到幻燈片 14。
Turning to Imfinzi but continuing within the lung cancer space, Imfinzi reported sales of $1.5 billion in the year, the majority of those sales coming from the U.S., which now represents 71% of the total sales that we saw for the year.
轉向 Imfinzi 但繼續在肺癌領域內, Imfinzi 報告全年銷售額為 15 億美元,其中大部分銷售額來自美國,目前占我們今年總銷售額的 71%。
Global approvals and reimbursements for the PACIFIC indication in unresectable Stage III non-small cell lung cancer are continuing to take effect.
全球對不可切除的 III 期非小細胞肺癌 PACIFIC 適應症的批准和報銷正在繼續生效。
Now the U.S. showed strong sales of $1 billion just for the country itself.
現在,美國僅針對該國本身就顯示出 10 億美元的強勁銷售額。
And we continue to see all of the metrics for post chemoradiotherapy increase as well as CRT rates are increasing within the U.S.
我們繼續看到美國境內放化療後的所有指標都在增加,CRT 率也在增加。
U.S. quarterly sequential growth was, however, impacted by some inventory movement in the quarter, and we also do see ourselves getting to a natural place of really being standard of care within the Stage III setting.
然而,美國季度環比增長受到本季度一些庫存變動的影響,我們也確實看到自己在第三階段環境中達到了真正成為標準護理的自然位置。
Sales outside the U.S., now 29% of the total, continued to ramp up as we launched and gained reimbursement in more countries.
隨著我們在更多國家/地區推出並獲得報銷,美國以外的銷售額(現在佔總銷售額的 29%)繼續增加。
Japan delivered $211 million in sales, Europe $179 million.
日本的銷售額為 2.11 億美元,歐洲為 1.79 億美元。
And in Europe, I think it's worth noting that with Imfinzi, still there are 2 of the 5 top European countries yet to get reimbursement.
在歐洲,我認為值得注意的是,對於 Imfinzi,歐洲排名前 5 位的國家中仍有 2 個尚未獲得報銷。
So there's further growth, obviously, that we've got as a result of getting those to come online and those negotiations are underway.
因此,顯然,由於讓這些上線並且這些談判正在進行中,我們得到了進一步的增長。
We look to grow sales further in the PACIFIC indication by continuing to focus on increasing the number of patients who might be eligible for Imfinzi by improving chemoradiation rates further driving Imfinzi utilization post chemoradiation and expanding the duration of treatment.
我們希望通過提高化放療率進一步推動放化療後 Imfinzi 利用率和延長治療持續時間,繼續專注於增加可能符合 Imfinzi 條件的患者數量,從而進一步增加 PACIFIC 適應症的銷售額。
More countries are anticipated to come online with further reimbursement decisions in the months to come.
預計未來幾個月將有更多國家上線並做出進一步的報銷決定。
In China, very noteworthy, PACIFIC gained approval in December 2019, so just at the very end of last year.
在中國,非常值得注意的是,PACIFIC 於 2019 年 12 月獲得批准,也就是去年年底。
We look for growth from that in the year ahead.
我們期待未來一年的增長。
And lastly, we are all anticipating further indications from lung cancer with small cell lung cancer throughout 2020 based upon the CASPIAN data.
最後,根據 CASPIAN 數據,我們都預計整個 2020 年肺癌和小細胞肺癌的進一步適應症。
Please turn to Slide 15.
請轉到幻燈片 15。
Turning to Lynparza.
轉向 Lynparza。
We demonstrated continued progress with sales of $1.2 billion in the year, up by 89%.
我們展示了持續的進步,全年銷售額達到 12 億美元,增長了 89%。
This reflected growth across all regions as we continue to roll out the breast and ovarian cancer indications in the major markets of the U.S., Europe and also within Japan.
隨著我們繼續在美國、歐洲和日本的主要市場推出乳腺癌和卵巢癌適應症,這反映了所有地區的增長。
Lynparza saw total PARP inhibitor class share increase in the U.S. and continued class-leading performance in all other major countries.
Lynparza 在美國的總 PARP 抑製劑類別份額有所增加,並在所有其他主要國家繼續保持同類領先的表現。
U.S. sales were $626 million, up by 81%, with continued increase in demand as we maintained leadership of Lynparza in the PARP inhibitor market both in ovarian cancer as well as in breast cancer.
美國銷售額為 6.26 億美元,增長 81%,需求持續增長,因為我們在卵巢癌和乳腺癌 PARP 抑製劑市場保持 Lynparza 的領先地位。
European sales were $287 million, up by 59%, driven primarily by first-line ovarian cancer launches in Germany also in the U.K., while Italy, Spain, France and other countries are still looking to gain reimbursement, but those discussions are ongoing for SOLO-1 in 2020.
歐洲銷售額為 2.87 億美元,增長 59%,主要受德國和英國一線卵巢癌上市的推動,而意大利、西班牙、法國和其他國家仍在尋求報銷,但有關 SOLO 的討論仍在進行中2020 年 -1。
In the second-line ovarian cancer setting, Lynparza continues to hold strong penetration rates across all major countries.
在二線卵巢癌治療中,Lynparza 在所有主要國家繼續保持強勁的滲透率。
In China, Lynparza was the first PARP inhibitor launched and it's contributed $133 million in sales in the emerging markets in the year.
在中國,Lynparza 是第一個推出的 PARP 抑製劑,它在這一年為新興市場貢獻了 1.33 億美元的銷售額。
The second-line indication was added to the NRDL last December in ovarian cancer and thus, is expected to drive growth into 2020.
去年 12 月卵巢癌的二線適應症被添加到 NRDL 中,因此預計將增長到 2020 年。
Finally, Japan delivered $130 million in sales in the year following the launches in ovarian and breast cancer.
最後,日本在卵巢癌和乳腺癌上市後的一年內實現了 1.3 億美元的銷售額。
We anticipate a further price cut though this April due to the market expansion or pricing rules.
由於市場擴張或定價規則,我們預計今年 4 月將進一步降價。
Those are similar rules as those that affected Tagrisso in November of last year.
這些規則與去年 11 月影響 Tagrisso 的規則類似。
And then as a reminder, Lynparza also generated significant value through collaboration revenue.
然後提醒一下, Lynparza 還通過合作收入產生了巨大的價值。
And in the future, collaboration revenue for Lynparza and for Enhertu through our profit share with Daiichi Sankyo will become an increasingly sustainable source of value creation that we will start to include in our reporting by medicine.
未來,Lynparza 和 Enhertu 通過我們與 Daiichi Sankyo 的利潤分成的合作收入將成為越來越可持續的價值創造來源,我們將開始將其納入我們的藥物報告中。
If you can now turn the slide to 16, and we're going to talk for a minute about the new launches, Calquence in chronic lymphocytic leukemia and Enhertu in third-line HER2-positive metastatic breast cancer.
如果你現在可以將幻燈片轉到 16,我們將花一分鐘時間談談新產品,慢性淋巴細胞白血病的 Calquence 和三線 HER2 陽性轉移性乳腺癌的 Enhertu。
I'm really pleased to announce and report the Calquence sales of $164 million in the year, predominantly within the U.S. with the new label in CLL taking effect at the end of November 2019.
我真的很高興地宣布和報告 Calquence 在這一年的銷售額為 1.64 億美元,主要是在美國,CLL 的新標籤將於 2019 年 11 月底生效。
The launch feedback has been really quite encouraging as the very promising Phase III data from ASCEND and ELEVATE-TN are really resonating very well with physicians.
發布反饋確實非常令人鼓舞,因為 ASCEND 和 ELEVATE-TN 非常有希望的 III 期數據確實引起了醫生的共鳴。
And we've got good responsiveness to the benefit risk profile that we're able to offer to patients in this setting.
我們對我們能夠在這種情況下為患者提供的利益風險狀況做出了良好的反應。
We're also really encouraged to see expansion in our prescriber base beyond the prescriber base that we had seen utilizing the medicine in MCL with around 60% of all new patient starts in CLL coming from new Calquence prescribers.
我們也很高興看到我們的處方者基礎擴大到我們在 MCL 中使用該藥物所看到的處方者基礎,大約 60% 的 CLL 新患者開始來自新的 Calquence 處方者。
On Enhertu, following the approval at the very end of 2019, the first sales to wholesalers were achieved on the 31st of December, and the first patient was infused 2 days later.
在 Enhertu 上,繼 2019 年底獲得批准後,於 12 月 31 日實現了對批發商的第一筆銷售,並在 2 天后輸注了第一位患者。
We've seen multiple hospital and community customers coming onboard as early adopters and initial feedback from physicians is strong as we bring the first new medicine to patients in this setting in many, many years, addressing a large unmet need.
我們已經看到多家醫院和社區客戶成為早期採用者,並且醫生的初步反饋很強烈,因為我們多年來為這種情況下的患者帶來了第一種新藥,解決了大量未滿足的需求。
A safety monitoring program is also in place and early feedback suggests that the management of key safety aspects is also really well understood.
安全監控計劃也已到位,早期反饋表明關鍵安全方面的管理也得到了很好的理解。
And we look forward to bringing Enhertu to more patients throughout the year as momentum builds following the positive gastric data that we just heard a few weeks ago.
隨著幾週前我們剛剛聽到的胃部積極數據的推動,我們期待著在全年將 Enhertu 帶給更多的患者。
Before ending, I'd like to thank all of our oncology colleagues around the world for making a difference every single day to the benefit of patients and to our company.
在結束之前,我要感謝我們在世界各地的所有腫瘤科同事,他們每天都在為患者和我們公司的利益做出改變。
I think the work that was done over the holiday break between December 20, Enhertu approval, and in early January, first patient being treated, demonstrates the commitment that our U.S. colleagues during Christmas and New Year has made to making sure that they put patients first in our lives, and I think that that's absolutely testimony to the mission at AstraZeneca.
我認為,從 12 月 20 日 Enhertu 獲批到 1 月初第一位患者接受治療期間的假期期間所做的工作表明,我們的美國同事在聖誕節和新年期間做出的承諾,即確保他們將患者放在首位在我們的生活中,我認為這絕對證明了阿斯利康的使命。
And with that, I'll now turn over the podium to Ruud Dobber for an update on our BioPharmaceuticals business and Emerging Markets.
就此,我現在將把講台交給 Ruud Dobber,介紹我們的生物製藥業務和新興市場的最新情況。
Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit
Thank you so much, Dave.
非常感謝你,戴夫。
For today, I'm very pleased to talk to you about the BioPharmaceutical business.
今天,我很高興與您談論生物製藥業務。
Total sales of BioPharma, comprising new cardiovascular, renal and metabolism and respiratory were $9.8 billion in the year, growing at 13%.
BioPharma 的總銷售額,包括新的心血管、腎臟和代謝以及呼吸系統,全年為 98 億美元,增長 13%。
It has now been 1 year since the integration of the BioPharma business units, and we are pleased to have made strong progress across the board.
生物製藥業務部門整合至今已有 1 年,我們很高興在各方面取得了長足的進步。
We have achieved double-digit growth in New CVRM and Respiratory as our new medicines continue to thrive.
隨著我們的新藥繼續蓬勃發展,我們在新 CVRM 和呼吸系統方面實現了兩位數的增長。
Please turn to Slide 18.
請轉到幻燈片 18。
As you see here, we are very pleased with the continued growth of Farxiga and Brilinta, the ongoing successful launch of Fasenra and the recent launch of Breztri in Japan.
正如您在這裡看到的,我們對 Farxiga 和 Brilinta 的持續增長、Fasenra 的持續成功推出以及最近在日本推出的 Breztri 感到非常高興。
In the established respiratory business, Symbicort and Pulmicort delivered encouraging performances and continue to grow.
在成熟的呼吸系統業務中,信必可和普米克取得了令人鼓舞的業績並繼續增長。
We look to build on this overall growth in 2020, including further launches of Lokelma and later in the year for roxadustat.
我們希望在 2020 年實現這一整體增長,包括進一步推出 Lokelma 以及在今年晚些時候推出 roxadustat。
Please turn to Slide 19.
請轉到幻燈片 19。
Moving to New CVRM, sales were up by 12% despite intense competition in diabetes with total sales of $4.4 billion.
轉向 New CVRM,儘管糖尿病競爭激烈,銷售額仍增長了 12%,總銷售額為 44 億美元。
Growth for both Farxiga and Brilinta continued with double-digit increases globally.
Farxiga 和 Brilinta 在全球繼續保持兩位數的增長。
Farxiga delivered sales of $1.5 billion with 14% growth, maintaining volume market leadership globally while benefiting from the SDLT 2 class growth.
Farxiga 實現了 15 億美元的銷售額,增長了 14%,保持了全球銷量市場的領先地位,同時受益於 SDLT 2 級增長。
In the U.S., Farxiga saw a reduction of 9% as price declines took effect though volumes continued to grow.
在美國,Farxiga 的銷量下降了 9%,原因是價格下降生效,但銷量繼續增長。
Outside the U.S., which accounts for 65% of sales, we saw very encouraging performances with volume-driven growth increasing.
在佔銷售額 65% 的美國以外,我們看到了非常令人鼓舞的業績,銷量驅動的增長也在增加。
European sales were up 25% driven by the DECLARE cardiovascular outcomes data, and emerging market sales were up by 48%.
在 DECLARE 心血管結局數據的推動下,歐洲銷售額增長了 25%,新興市場銷售額增長了 48%。
Bydureon sales were down by 5% at $549 million.
Bydureon 的銷售額下降了 5%,為 5.49 億美元。
We returned to growth in the last quarter following the impact of production constraints in the first half year for the Bydureon BCise device and declining volumes for the Dual Chamber Pen.
受上半年 Bydureon BCise 設備生產限制和雙腔筆銷量下降的影響,我們在上個季度恢復了增長。
Brilinta delivered sales of $1.6 billion with 23% growth driven by a strong performance in the emerging markets, up by 49%.
Brilinta 實現銷售額 16 億美元,增長 23%,這得益於新興市場的強勁表現,增長了 49%。
We also had continuous growth in the U.S. and Europe, up by 21% and 7%, respectively.
我們在美國和歐洲也持續增長,分別增長了 21% 和 7%。
Brilinta continues to outgrow the market in all regions and we also note the recent positive THALES trial in stroke.
Brilinta 繼續在所有地區超越市場,我們也注意到最近 THALES 試驗在中風方面取得的積極成果。
Please turn to Slide 20.
請轉到幻燈片 20。
Turning to Respiratory.
轉向呼吸科。
We saw our first year of growth since 2014 with 13% growth in the year driven by Fasenra, Symbicort and Pulmicort.
我們看到了自 2014 年以來的第一年增長,在 Fasenra、Symbicort 和 Pulmicort 的推動下,這一年增長了 13%。
Symbicort was stable in the year at $2.5 billion and saw growth returning in the second half of the year.
Symbicort 在這一年穩定在 25 億美元,並在下半年恢復增長。
The fourth quarter was up by 13%.
第四季度增長了 13%。
This was driven by easing of U.S. pricing pressure, growth in Japan and in the emerging markets, the latter up by 17%.
這是由於美國定價壓力的緩解、日本和新興市場的增長推動的,後者增長了 17%。
Many countries such as Russia, South Korea and Mexico saw double-digit growth in sales.
俄羅斯、韓國和墨西哥等許多國家的銷售額都實現了兩位數的增長。
Globally, Symbicort remained the leader in volume market share in the ICS/LABA class and became the value leader as well.
在全球範圍內,Symbicort 仍然是 ICS/LABA 類別中體積市場份額的領導者,並且也成為價值領導者。
Pulmicort was up by 18% with sales of $1.5 billion with emerging markets up by 24% as the driver of this growth, particularly in China.
Pulmicort 增長了 18%,銷售額為 15 億美元,新興市場增長了 24%,這是這一增長的推動力,尤其是在中國。
Please turn to Slide 21.
請轉到幻燈片 21。
Now I will focus on the new launch medicines.
現在我將專注於新推出的藥物。
Fasenra contributed $704 million of sales with the bulk continuing to come from the U.S., Germany and Japan.
Fasenra 貢獻了 7.04 億美元的銷售額,其中大部分繼續來自美國、德國和日本。
In the U.S., Fasenra is performing very well against new competitors with $482 million in sales.
在美國,Fasenra 以 4.82 億美元的銷售額與新的競爭對手相比表現出色。
Europe and Japan sales were $118 million and $86 million, respectively, as Fasenra continued to be the leading novel biological medicine for severe uncontrolled asthma in several countries.
歐洲和日本的銷售額分別為 1.18 億美元和 8600 萬美元,因為 Fasenra 在幾個國家仍然是嚴重未控制哮喘的領先新型生物藥物。
The self-administration Fasenra Pen auto-injector device will become an additional opportunity for growth in the U.S. and Europe.
自我管理的 Fasenra Pen 自動注射器設備將成為美國和歐洲增長的額外機會。
We're also currently launching PT010, known as Breztri Aerosphere for COPD in Japan, which is going well, and China is launching relatively soon as well.
我們目前還推出了 PT010,在日本被稱為 Breztri Aerosphere for COPD,進展順利,中國也相對較快推出。
Regulatory reviews in the U.S. and in the EU are progressing with anticipated decisions in the second half of 2020.
美國和歐盟的監管審查正在取得進展,預計將在 2020 年下半年做出決定。
Lokelma had sales of $40 million in the year as the U.S. launch recently commenced and has already surpassed the competitor in new-to-brand prescriptions.
Lokelma 在美國的上市最近開始,當年的銷售額為 4000 萬美元,並且在新品牌處方方面已經超過了競爭對手。
Similar success has also been achieved in some of the other countries, especially in Europe.
其他一些國家也取得了類似的成功,尤其是在歐洲。
Now we'll move to the emerging markets, please turn to Slide 22.
現在我們將轉向新興市場,請轉到幻燈片 22。
Emerging markets, where sales grew by 24% in 2019, continued to track ahead of our long-term performance ambition, which is to grow sales on average by mid to high single-digit percentage.
2019 年銷售額增長 24% 的新興市場繼續領先於我們的長期業績目標,即銷售額平均增長中高個位數百分比。
Outside China, overall sales were up by 12% with growth spread across all the regions.
在中國以外地區,整體銷售額增長了 12%,增長遍及所有地區。
China delivered another very strong year with 35% growth and finished on a strong fourth quarter with 28% growth and with the new launches continuing to take effect.
中國以 35% 的增長率又迎來了非常強勁的一年,並以 28% 的增長率結束了強勁的第四季度,新推出的產品繼續發揮作用。
As in previous years, there was a slowdown in the final quarter.
與往年一樣,最後一個季度出現了放緩。
The addition of Lynparza, Farxiga and roxadustat to the NRDL effective January 2020 will start to make a favorable impact on sales moving forward.
從 2020 年 1 月起將 Lynparza、Farxiga 和 roxadustat 添加到 NRDL 將開始對銷售產生有利影響。
New medicines grew by 84%, contributing 23% of total sales in the region with the strong performance spread across our main therapy areas.
新藥增長了 84%,佔該地區總銷售額的 23%,強勁的表現遍及我們的主要治療領域。
Overall, Oncology was up by 52% in the emerging markets driven by Tagrisso.
總體而言,腫瘤學在 Tagrisso 的推動下在新興市場增長了 52%。
New CVRM was up 41% with key contributions from both Farxiga and Brilinta.
新的 CVRM 上漲了 41%,主要貢獻來自 Farxiga 和 Brilinta。
And finally, Respiratory sales were up by 27% with Pulmicort and Symbicort leading.
最後,在 Pulmicort 和 Symbicort 的帶動下,呼吸系統銷售額增長了 27%。
Please turn to Slide 23.
請轉到幻燈片 23。
The potential of emerging markets is unchanged, and the markets continued to be of a large strategic importance.
新興市場的潛力沒有改變,市場繼續具有重要的戰略意義。
Despite the impact of the coronavirus right now in China, we generally anticipate to continue outperforming the long-term trends with average sales growth in the emerging markets to be as high as low double-digit percentage per year.
儘管目前在中國受到冠狀病毒的影響,但我們總體上預計將繼續跑贏長期趨勢,新興市場的平均銷售額增長率將高達每年兩位數的百分比。
As Pascal said earlier, we remain impressed by the resilience of the leadership [and colleagues] in China given the coronavirus challenges in the country.
正如 Pascal 早些時候所說,鑑於中國面臨冠狀病毒挑戰,我們對中國領導層 [和同事] 的韌性印象深刻。
And with this, I will hand over to Marc.
有了這個,我將交給馬克。
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
Thank you, Ruud, and hello, everyone.
謝謝你,Ruud,大家好。
I want to take you through our financial performance in the year and the fourth quarter as well as our financial priorities and our guidance for 2020.
我想向您介紹我們今年和第四季度的財務業績,以及我們的財務重點和我們對 2020 年的指導。
But before I do that, I would like to provide a summary of our 2019 financial achievements.
但在此之前,我想總結一下我們 2019 年的財務成就。
With the progress we are making, it is right to recognize the work of so many of our colleagues, we have achieved a great deal in this year.
隨著我們取得的進步,承認這麼多同事的工作是正確的,我們在這一年取得了很大的成就。
I've listed some examples on the slide.
我在幻燈片上列出了一些例子。
In finance, we have gone through a transformation program in the last 3 years.
在金融領域,我們在過去 3 年經歷了轉型計劃。
From a multiplicity of divisional financial systems, we consolidated everything into 1 planning and reporting tool.
我們將多個部門財務系統整合到一個規劃和報告工具中。
Having a better grasp of the single source of [tools] was the first objective.
更好地掌握[工具]的單一來源是第一個目標。
We have also built new functionalities such as project accounting across the whole company.
我們還在整個公司構建了新功能,例如項目會計。
This new system enabled us to rapidly adjust to the organization changes such as the one we put in place in our R&D.
這個新系統使我們能夠快速適應組織變化,例如我們在研發中實施的變化。
Overall, the finance team can dedicate more time to supporting the alliances that we have set up with Merck, Daiichi Sankyo or FibroGen, for instance.
總體而言,財務團隊可以投入更多時間來支持我們與 Merck、Daiichi Sankyo 或 FibroGen 等建立的聯盟。
On the front of new technologies, we have now 100 robots in use not only in finance, but across the whole company, in HR, medical, commercial and R&D.
在新技術的前沿,我們現在有 100 台機器人在使用,不僅在財務領域,而且在整個公司的人力資源、醫療、商業和研發領域都有使用。
And we are learning to generate more value added from each robot.
我們正在學習從每個機器人中產生更多的附加值。
Please turn to Slide 26.
請轉到幻燈片 26。
Turning now to financial performance, I will start with the reported P&L before reviewing our core results.
現在轉向財務業績,在回顧我們的核心業績之前,我將從報告的損益開始。
As Pascal mentioned earlier, product sales grew by 15% in the year, while around 75% of collaboration revenue comprise payments for Merck in respect of the success of Lynparza.
正如 Pascal 之前提到的,產品銷售額在這一年增長了 15%,而約 75% 的合作收入包括默克因 Lynparza 的成功而支付的費用。
In the future, a growing share of collaboration revenue will represent income from the sales of new medicine through our partners, including Enhertu and roxadustat, in addition to the milestone income resulting from progress of medicines such as Lynparza.
未來,合作收入中越來越大的份額將代表通過我們的合作夥伴(包括 Enhertu 和 roxadustat)銷售新藥的收入,以及 Lynparza 等藥物進展帶來的里程碑收入。
And therefore, we will now guide on total revenue rather than just on product sales to reflect these changes.
因此,我們現在將指導總收入,而不僅僅是產品銷售,以反映這些變化。
We will continue to provide detailed financial information on our direct product sales as well as on the collaboration revenues.
我們將繼續提供有關我們的直接產品銷售以及合作收入的詳細財務信息。
Looking further down the reported P&L, operating expenses increased by 14% in the year.
進一步查看報告的損益表,全年運營費用增長了 14%。
On top of the increase of core operating expenses that I will refer to in the following slide, part of the increase was due to an intangible asset impairment for Epanova.
除了我將在下一張幻燈片中提到的核心運營費用增加外,增加的部分原因是 Epanova 的無形資產減值。
Please turn to Slide 27.
請轉到幻燈片 27。
Moving to the core P&L.
轉向核心損益。
Our gross margin was broadly stable at 80% but was negatively impacted by around 0.5 percentage point from the impact of a provision regarding Epanova inventory.
我們的毛利率大致穩定在 80%,但因 Epanova 庫存準備金的影響而受到約 0.5 個百分點的負面影響。
Core operating expenses grew by 7% in the year with core R&D expenses up 4% as we invested for the first time in Enhertu.
由於我們首次投資 Enhertu,核心運營費用在這一年增長了 7%,核心研發費用增長了 4%。
Core SG&A expenses increased by 8% driven by additional investment in the China expansion and further support for new medicine.
受中國擴張的額外投資和對新藥的進一步支持,核心 SG&A 費用增長了 8%。
The sum of collaboration revenue and core other operating income fell by 25% to $2.4 billion from $3.2 billion in 2018.
協作收入和其他核心營業收入的總和從 2018 年的 32 億美元下降 25% 至 24 億美元。
Other operating income will remain a significant part of our P&L in 2020 and beyond as we need to include, for example, the funding by Allergan of the development cost of brazikumab, the IL-23 antibody that we recovered recently, subject to regulatory approval in closing.
其他營業收入在 2020 年及以後仍將是我們損益的重要組成部分,因為我們需要包括例如艾爾建(Allergan)對我們最近回收的 IL-23 抗體 brazikumab 的開發成本的資助,但須經監管部門批准關閉。
With a core tax rate of 20%, a rise in net finance expenses, reduced divestment activity and a higher number of shares, our core earnings per share ended at $3.50 for the year.
由於核心稅率為 20%,淨財務費用增加,撤資活動減少以及股票數量增加,我們全年的核心每股收益為 3.50 美元。
Please turn to Slide 28.
請轉到幻燈片 28。
Turning to net debt and cash generation.
轉向淨債務和現金產生。
Our net debt, adjusted for IFRS 16, declined by $1.6 billion to $11.9 billion at the end of 2019.
到 2019 年底,根據 IFRS 16 調整後的淨債務減少了 16 億美元,降至 119 億美元。
We had a higher-than-average level of purchase of intangible assets, highlighted by the first upfront payment in respect of Enhertu as well as the final true-up payment of around $400 million to Merck.
我們的無形資產購買水平高於平均水平,突出體現在對 Enhertu 的第一筆預付款以及對默克約 4 億美元的最終調整付款。
Capital expenditures remained stable at $979 million and anticipate a broadly similar level for 2020.
資本支出穩定在 9.79 億美元,預計 2020 年的水平大致相似。
Looking at net cash from operations, we made encouraging progress in the year.
從運營產生的現金淨額來看,我們在這一年取得了令人鼓舞的進展。
Underlying business performance helped to deliver cash from operating activities of around $3 billion in the year.
基礎業務績效幫助當年從經營活動中交付了約 30 億美元的現金。
This was despite an increase of $581 million in cash tax reflecting the phasing of tax payment and the impact of tax refunds in 2018.
儘管現金稅增加了 5.81 億美元,這反映了 2018 年納稅的分階段和退稅的影響。
Despite the higher core operating profit and lower restructuring costs in 2019, our reported EBITDA was marginally lower due to higher legal provisions in 2019.
儘管 2019 年核心營業利潤較高且重組成本較低,但由於 2019 年的法律規定較高,我們報告的 EBITDA 略有下降。
Please turn to Slide 29.
請轉到幻燈片 29。
This familiar slide continues to demonstrate how we are progressing from the reconstitution of our pipeline to return to growth.
這張熟悉的幻燈片繼續展示了我們是如何從管道重建到恢復增長的。
We are now in the next phase where we work on our operating leverage.
我們現在正處於下一階段,我們將致力於提高運營槓桿。
We anticipate the cash flow generation to increase in the subsequent years, which will then help us deleverage our balance sheet further and over time, further address the dividend policy.
我們預計未來幾年產生的現金流會增加,這將有助於我們隨著時間的推移進一步去槓桿化我們的資產負債表,進一步解決股息政策問題。
Our unchanged ambition is to cover the dividend next year with cash flows generated during the year.
我們不變的目標是用當年產生的現金流來支付明年的股息。
Please turn to Slide 30.
請轉到幻燈片 30。
Finally, I will turn to the 2020 guidance, which, as I mentioned a moment ago, is now on total revenue and core earnings per share at constant exchange rates.
最後,我將談談 2020 年的指引,正如我剛才提到的,現在是按固定匯率計算的總收入和每股核心收益。
As Pascal mentioned, our guidance considers some impact of the coronavirus epidemic.
正如 Pascal 提到的,我們的指南考慮了冠狀病毒流行的一些影響。
We are presently taking into account an impact of up to a few months, and we will provide an update at our [first] quarter 2020 results.
我們目前正在考慮長達幾個月的影響,我們將在 2020 年 [第一] 季度的結果中提供更新。
In 2020, like in 2019, we will increase our operating leverage, thanks to a high single-digit to low double-digit percentage increase in total revenue.
2020 年,與 2019 年一樣,我們將提高經營槓桿率,這要歸功於總收入的高個位數到低兩位數的百分比增長。
This is anticipated to drive growth in core EPS of a mid- to high-teens percentage increase.
預計這將推動核心每股收益以中高百分比增長。
We remain focused on improving operating leverage in 2020.
2020 年,我們仍然專注於提高經營槓桿。
The core tax rate is anticipated to be between 18% and 22%.
核心稅率預計在 18% 至 22% 之間。
And as I said earlier, capital expenditure is expected to be broadly stable versus 2019.
正如我之前所說,與 2019 年相比,資本支出預計將大致穩定。
With that, I will now hand over to José.
有了這個,我現在將交給何塞。
José Baselga - Executive Vice-President of Oncology Research & Development
José Baselga - Executive Vice-President of Oncology Research & Development
Thank you, Marc, and good afternoon, everyone.
謝謝馬克,大家下午好。
I am happy to provide an update on the progress that we have made with our medicines in Oncology and pipeline since the results announcement last October.
我很高興提供自去年 10 月公佈結果以來我們在腫瘤學和管道藥物方面取得的最新進展。
As usual, I am joined by my counterpart, Mene Pangalos, who will discuss BioPharmaceuticals pipeline and upcoming news flows.
像往常一樣,我的同行 Mene Pangalos 也加入了我的行列,他將討論生物製藥管道和即將到來的新聞流。
If we could turn to Slide 32, please.
請轉到幻燈片 32。
This is a busy slide.
這是一張繁忙的幻燈片。
2019 was a fantastic year for the company's pipeline progression.
2019 年是公司管道進展的精彩一年。
And as Pascal said earlier, we achieved a remarkable level of positive news from approvals to data readouts and regulatory designations.
正如 Pascal 早些時候所說,從批准到數據讀出和監管指定,我們取得了顯著的積極消息。
I would like now to highlight some of these achievements.
我現在想強調其中的一些成就。
Starting with our oncology medicines, Lynparza continued to build a solid base -- a solid base of data in other tumor types outside of ovarian, including U.S. approval in pancreatic and a positive readout in prostate cancers.
從我們的腫瘤藥物開始,Lynparza 繼續建立堅實的基礎——卵巢以外其他腫瘤類型的堅實數據基礎,包括美國批准的胰腺癌和前列腺癌的陽性讀數。
Lynparza also secured further approvals in major markets in ovarian and breast cancers.
Lynparza 還在卵巢癌和乳腺癌的主要市場獲得了進一步的批准。
In lung cancer, we gained approval for Tagrisso and Imfinzi in China, building on the unprecedented data from the FLAURA trial in first-line eGFR mutated setting and the PACIFIC trial in unresectable Stage III patients, respectively.
在肺癌方面,我們在中國獲得了 Tagrisso 和 Imfinzi 的批准,分別基於在一線 eGFR 突變環境中進行的 FLAURA 試驗和在不可切除的 III 期患者中進行的 PACIFIC 試驗的前所未有的數據。
Kicking off our hematology franchise, we achieved first- and second-line approvals for Calquence in CLL in the U.S. In CVRM, Farxiga achieved approval in both the EU and the U.S. for the cardiovascular outcomes claim in type 2 diabetes and landmark DAPA-HF data were presented in the early autumn.
開始我們的血液學專營權,我們在美國 CLL 中獲得了 Calquence 的一線和二線批准。在 CVRM 中,Farxiga 在歐盟和美國獲得了 2 型糖尿病心血管結果聲明和具有里程碑意義的 DAPA-HF 數據的批准是在初秋推出的。
We also had roxadustat approval in China.
我們在中國也獲得了 roxadustat 的批准。
Finally, in Respiratory, we had positive ETHOS data for PT010 and gained approval for both Bevespi and Breztri in Japan, all in the treatment of COPD.
最後,在呼吸方面,我們獲得了 PT010 的積極 ETHOS 數據,並在日本獲得了用於治療 COPD 的 Bevespi 和 Breztri 的批准。
Please turn to Slide 33.
請轉到幻燈片 33。
I'll focus now in -- on recent Oncology achievements.
我現在將重點放在——最近的腫瘤學成就上。
With Imfinzi, in addition to the regulatory approval for unresectable Stage III non-small cell lung cancer in China, we also completed regulatory submissions based on the positive CASPIAN trial looking at the treatment of extensive disease small cell lung cancer.
與 Imfinzi 一起,除了在中國獲得對不可切除的 III 期非小細胞肺癌的監管批准外,我們還完成了基於針對廣泛性疾病小細胞肺癌治療的陽性 CASPIAN 試驗的監管提交。
Of note, I'd like to let you know that we have already our first patient in China treated with Imfinzi based on the Stage III data.
值得注意的是,我想告訴您,我們已經有第一位中國患者根據 III 期數據接受了 Imfinzi 治療。
Lynparza continues to expand the life cycle program with U.S. approval in the first-line maintenance treatment of BRCA-mutated pancreatic cancer and regulatory submission acceptances in the EU and in the U.S. with a priority review in the latter for previously treated prostate cancer with HRR genetic mutations.
Lynparza 繼續擴大生命週期計劃,美國批准用於 BRCA 突變胰腺癌的一線維持治療,並在歐盟和美國獲得監管提交驗收,後者優先審查先前治療過的具有 HRR 基因的前列腺癌突變。
The first-line ovarian cancer trial in all-comers with Avastin was submitted in Japan and the EU and gained U.S. priority review.
Avastin 的一線卵巢癌試驗已在日本和歐盟提交,並獲得美國的優先審查。
Selumetinib also gained U.S. priority review for the treatment of neurofibromatosis.
Selumetinib 還獲得了美國治療神經纖維瘤病的優先審查。
In hematology, we were delighted to see broad CLL approval, and we subsequently launched Calquence in chronic lymphocytic leukemia in the U.S. through the Real-Time Oncology Review pilot program.
在血液學方面,我們很高興看到 CLL 獲得廣泛批准,隨後我們通過實時腫瘤學審查試點項目在美國推出了用於治療慢性淋巴細胞白血病的 Calquence。
We completed submission for Calquence in Japan and have received submission acceptance in the EU.
我們在日本完成了 Calquence 的提交,並在歐盟獲得了提交接受。
As a reminder, at the ASH meeting in December, we showed data from the interim analysis of the Phase III ELEVATE-TN trial.
提醒一下,在 12 月的 ASH 會議上,我們展示了 III 期 ELEVATE-TN 試驗的中期分析數據。
Calquence combined with obinutuzumab or as monotherapy.
Calquence 與 obinutuzumab 聯合使用或作為單一療法。
Significantly improved PFS compared to chlorambucil plus obinutuzumab, a standard chemoimmunotherapy treatment in patients with previously untreated CLL.
與苯丁酸氮芥加 obinutuzumab 相比,PFS 顯著改善,後者是先前未治療的 CLL 患者的標準化學免疫療法。
At a median of 28.3 months, Calquence in combination with obinutuzumab or as monotherapy significantly reduced the risk of disease progression or death by 90% and 80%, respectively, versus chlorambucil plus obinutuzumab.
與苯丁酸氮芥加 obinutuzumab 相比,Calquence 聯合 obinutuzumab 或作為單一療法的中位時間為 28.3 個月,分別將疾病進展或死亡的風險顯著降低了 90% 和 80%。
The safety profile was consistent with prior trials.
安全性與之前的試驗一致。
Let's turn to Slide 34, please.
請轉到幻燈片 34。
And now to Enhertu, our breakthrough HER2 -- our breakthrough medicine in HER2-positive breast cancer that recently gained approval in the U.S. in collaboration with our partner, Daiichi Sankyo.
現在是 Enhertu,我們的突破性 HER2——我們在 HER2 陽性乳腺癌中的突破性藥物,最近與我們的合作夥伴第一三共(Daiichi Sankyo)合作在美國獲得批准。
We received U.S. approval for Enhertu 4 months ahead of its scheduled PDUFA date.
我們比預定的 PDUFA 日期提前 4 個月獲得了美國對 Enhertu 的批准。
Based on results from the DESTINY-Breast01 trial where Enhertu monotherapy show a confirmed objective response rate of 60.9% despite patients having had a median of 6 prior medicines.
根據 DESTINY-Breast01 試驗的結果,Enhertu 單藥療法顯示確認的客觀反應率為 60.9%,儘管患者之前服用的藥物中位數為 6 種。
Patients achieved a median duration of response of 14.8 months and a median progression-free survival of 16.4 months.
患者的中位反應持續時間為 14.8 個月,中位無進展生存期為 16.4 個月。
The median overall survival is still to be reached with an estimated survival rate of 86% at 1 year.
中位總生存期仍未達到,估計 1 年生存率為 86%。
Recently, we announced top line results for the DESTINY-Gastric01 trial.
最近,我們公佈了 DESTINY-Gastric01 試驗的主要結果。
Enhertu achieved a significant and clinically meaningful improvement in objective response rate and overall survival in patients with third-line HER2-positive unresectable or metastatic gastric or gastroesophageal junction cancer.
Enhertu 在三線 HER2陽性不可切除或轉移性胃癌或胃食管交界處癌患者的客觀反應率和總生存期方面取得了顯著且具有臨床意義的改善。
Regulatory submission is planned for the first half of this year.
計劃於今年上半年提交監管文件。
Let's please turn to Slide 35.
讓我們轉到幻燈片 35。
Finally, I would like to take you through a quick update on progress on just some of our exciting new oncology medicines in early development as we build our key oncology competencies.
最後,我想帶您快速了解一下在我們建立關鍵腫瘤學能力的過程中,我們在早期開發中的一些令人興奮的新腫瘤藥物的進展情況。
We have started Phase II trials for AZD9833, our oral SERD for the treatment of estrogen receptor-positive breast cancer.
我們已經開始 AZD9833 的 II 期試驗,這是我們用於治療雌激素受體陽性乳腺癌的口服 SERD。
We are about to start Phase II trials for our bispecific PD-1/CTLA-4, MED1517, sorry 15752 (sic) [MEDI5752], which will be assessed for the treatment of a variety of solid tumors.
我們即將開始我們的雙特異性 PD-1/CTLA-4,MED1517,抱歉 15752(原文如此)[MEDI5752] 的 II 期試驗,將評估其對各種實體瘤的治療效果。
In an expansion of our hematology franchise, we have started Phase I trials for AZD0466, our BCL-2/xL inhibitor.
為了擴大我們的血液學專營權,我們已經開始了 AZD0466(我們的 BCL-2/xL 抑製劑)的 I 期試驗。
We have other medicines in the clinic, such as AZD5991, an intravenous MCL inhibitor and potentially differentiated medicine for use in blood cancer.
我們在臨床上還有其他藥物,例如 AZD5991,一種靜脈注射 MCL 抑製劑和用於血癌的潛在差異化藥物。
And ceralasertib, our ATR inhibitor, which can potentially aid in overcoming PARP resistance when added to Lynparza.
還有我們的 ATR 抑製劑 ceralasertib,將其添加到 Lynparza 後可能有助於克服 PARP 耐藥性。
We look forward to update you on the progress of these drugs in due course.
我們期待在適當的時候向您更新這些藥物的進展。
And with this, I'd like to hand over to Mene.
有了這個,我想交給梅內。
Thank you.
謝謝你。
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
Thank you, José.
謝謝你,何塞。
Good afternoon, everyone.
大家下午好。
Happy Valentine's Day.
情人節快樂。
I hope you enjoy your chocolate treats again from our IR team.
我希望您能再次享受我們 IR 團隊提供的巧克力美食。
I'd like to start by reflecting on the synergies in our cardiovascular, renal and metabolism portfolio and highlight the fact that our medicines often treat more than one aspect of a given disease.
我想首先反思我們心血管、腎臟和新陳代謝產品組合的協同作用,並強調一個事實,即我們的藥物通常可以治療特定疾病的多個方面。
We continue to work on indications, including heart failure, chronic kidney disease, diabetes, myocardial infarction and NASH across the CVRM spectrum.
我們繼續致力於適應症,包括心力衰竭、慢性腎病、糖尿病、心肌梗塞和 NASH 等 CVRM 譜系。
For example, patients with chronic kidney disease often show deterioration in cardiac function, resulting in heart failure.
例如,患有慢性腎病的患者經常表現出心臟功能惡化,導致心力衰竭。
Furthermore, as their kidney function continues to decline, patients face an increased risk of developing other complications, including anemia and hyperkalemia, both associated with increased hospitalization and mortality.
此外,隨著腎功能持續下降,患者面臨其他並發症的風險增加,包括貧血和高鉀血症,這兩者都與住院率和死亡率增加有關。
By understanding the comorbidities across the CVRM spectrum, we can better position our molecules to improve both patient outcomes and quality of life as well as supporting health care systems globally.
通過了解整個 CVRM 範圍內的合併症,我們可以更好地定位我們的分子,以改善患者的治療效果和生活質量,並支持全球醫療保健系統。
Please turn to Slide 37.
請轉到幻燈片 37。
I'll now update you on our recent R&D progress made in the CVRM space.
我現在將向您介紹我們最近在 CVRM 領域取得的研發進展。
We are pleased with Farxiga as it moves beyond diabetes and into heart failure treatment with regulatory submissions for DAPA-HF completed in all major markets and priority review granted in the U.S. Brilinta saw the submission of the THEMIS data set in Japan and China in the period, and we also recently announced positive top line results for the THALES trial in stroke.
我們對 Farxiga 感到滿意,因為它超越了糖尿病,進入了心力衰竭治療領域,所有主要市場都完成了 DAPA-HF 的監管提交,並在美國獲得了優先審評。Brilinta 在此期間看到了日本和中國提交的 THEMIS 數據集,我們最近還宣布了 THALES 中風試驗的積極頂線結果。
In renal, Lokelma gained regulatory approval in China for the treatment of hyperkalemia.
在腎臟方面,Lokelma 在中國獲得監管批准用於治療高鉀血症。
And roxadustat, our HIF prolyl hydroxylase inhibitor for the treatment of anemia from CKD received regulatory submission acceptance in the U.S. by our collaborator, FibroGen.
我們用於治療 CKD 貧血的 HIF 脯氨酰羥化酶抑製劑 roxadustat 在美國獲得了我們的合作者 FibroGen 的監管提交驗收。
For roxadustat, following the positive high-level Phase III pooled analysis that we presented in May, FibroGen and AstraZeneca presented that efficacy at the American Society of Nephrology Kidney Week in November.
對於 roxadustat,繼我們在 5 月提出的積極的高水平 III 期匯總分析之後,FibroGen 和阿斯利康在 11 月的美國腎髒病學會腎臟週上展示了該功效。
The analysis, which assessed roxadustat as a potential new medicine for the treatment of patients with anemia from chronic kidney disease, showed positive efficacy with cardiovascular safety demonstrated in all the studied populations.
該分析評估了羅沙司他作為治療慢性腎病貧血患者的潛在新藥,結果顯示在所有研究人群中均顯示出積極的療效和心血管安全性。
And as I said this week, our collaboration partner, FibroGen, announced the regulatory acceptance for the new drug application to the FDA, and we anticipate a decision in the fourth quarter of this year.
正如我本週所說,我們的合作夥伴 FibroGen 宣布監管機構接受了向 FDA 提交的新藥申請,我們預計將在今年第四季度做出決定。
Can we please turn to Slide 38?
我們可以轉到幻燈片 38 嗎?
Turning to Respiratory.
轉向呼吸科。
We made good progress with our health franchises in China through regulatory submission of Symbicort for the treatment of mild asthma and the regulatory approval for our triple therapy medicine Breztri for the treatment of COPD.
通過向監管機構提交用於治療輕度哮喘的 Symbicort 以及用於治療 COPD 的三聯療法藥物 Breztri 獲得監管批准,我們在中國的健康特許經營取得了良好進展。
At the American College of Rheumatology Annual Meeting last November, we presented the Phase III TULIP program for anifrolumab, a potential new medicine for the treatment of lupus.
在去年 11 月的美國風濕病學會年會上,我們介紹了 anifrolumab 的 III 期 TULIP 計劃,這是一種潛在的治療狼瘡的新藥。
The second trial, TULIP 2, met its primary endpoint, achieving statistically significant and clinically meaningful reduction in disease activity as measured by an early and sustained BICLA response.
第二項試驗 TULIP 2達到了其主要終點,通過早期和持續的 BICLA 反應來衡量,疾病活動度在統計學上顯著且具有臨床意義。
The full data set will be part of our regulatory submission in the second half of this year.
完整的數據集將成為我們今年下半年提交的監管文件的一部分。
Lastly, we announced the recovery of brazikumab, an IL-23 monoclonal antibody from Allergan.
最後,我們宣布從 Allergan 回收 brazikumab,一種 IL-23 單克隆抗體。
Brazikumab is currently in late-stage development for the treatment of 2 inflammatory bowel diseases, Crohn's disease and ulcerative colitis.
Brazikumab 目前正處於治療 2 種炎症性腸病、克羅恩病和潰瘍性結腸炎的後期開發階段。
And as you know, Allergan would be paying for the R&D cost to commercialization.
如您所知,Allergan 將支付商業化的研發成本。
We will update you on future milestones for this potential new medicine.
我們將為您更新這種潛在新藥的未來里程碑。
We are pleased to have added our 17th Phase III program subject to regulatory approving and closing.
我們很高興增加了我們的第 17 個 III 期計劃,但需獲得監管部門的批准和關閉。
Please turn to Slide 39.
請轉到幻燈片 39。
And now for an update on progress on what's next in the pipeline for BioPharmaceuticals.
現在了解有關生物製藥管道下一步進展的最新進展。
If I start in CVRM, we started Phase II trials for our dual-acting GLP-1/glucagon agonist cotadutide.
如果我從 CVRM 開始,我們就開始了雙作用 GLP-1/胰高血糖素激動劑 cotadutide 的 II 期試驗。
It recently gained fast track designation in the U.S. for the treatment of NASH.
它最近在美國獲得了治療 NASH 的快速通道指定。
Also in NASH, our PNPLA3 inhibitor is our first precision medicine for NASH, AZD2693, has entered Phase I clinical development.
同樣在 NASH 方面,我們的 PNPLA3 抑製劑是我們第一個針對 NASH 的精準藥物 AZD2693,已進入 I 期臨床開發。
In Respiratory, we now have positive data from a Phase II study of our inhaled SGRM AZD7594, and we'll share that data in due course.
在呼吸方面,我們現在從我們的吸入 SGRM AZD7594 的 II 期研究中獲得了積極的數據,我們將在適當的時候分享這些數據。
We've started Phase II trials in atopic dermatitis and diabetic kidney disease for MEDI3506, our IL-33 monoclonal antibody, with trials in aspirin COPD also set to continue this year to start this year.
我們已經開始了我們的 IL-33 單克隆抗體 MEDI3506 在特應性皮炎和糖尿病腎病方面的 II 期試驗,阿司匹林 COPD 的試驗也將於今年繼續進行。
And MEDI3506 -- yes, sorry, is going to start in aspirin COPD.
MEDI3506——是的,抱歉,將從阿司匹林 COPD 開始。
Finally, in the second half of the year, we'll have data for PT027, our anti-inflammatory reliever, aiming to replace SABA monotherapy for asthma patients.
最後,在今年下半年,我們將獲得我們的抗炎緩解劑 PT027 的數據,旨在取代 SABA 單藥治療哮喘患者。
And throughout the year, we look forward to updating you on the progress of these medicines and other exciting potential, disease modifiers, such as our dual PI3 kinase gamma/delta inhibitor and our inhaled JAK1 inhibitor.
在這一年中,我們期待著向您介紹這些藥物和其他令人興奮的潛力、疾病調節劑的最新進展,例如我們的雙重 PI3 激酶 gamma/delta 抑製劑和我們的吸入 JAK1 抑製劑。
I'll now take you through our upcoming news flow across the pipeline.
我現在將帶您了解我們即將發布的整個管道的新聞流。
In the first half of this year, in Oncology, we are anticipating regulatory decisions for Imfinzi in small cell lung cancer in the U.S.; Lynparza, PAOLA-1 and prostate in the U.S.; and for Enhertu in breast cancer in Japan.
今年上半年,在腫瘤學領域,我們預計美國將針對 Imfinzi 治療小細胞肺癌做出監管決定;美國的 Lynparza、PAOLA-1 和前列腺;以及在日本用於治療乳腺癌的 Enhertu。
We would also have data in first-line head and neck cancer and first-line bladder cancer for Imfinzi and the combination of Lynparza and cediranib, our VEGF inhibitor.
我們還將獲得 Imfinzi 以及 Lynparza 和 cediranib(我們的 VEGF 抑製劑)的組合在一線頭頸癌和一線膀胱癌方面的數據。
We announced positive gastric cancer for Enhertu last month with regulatory submission planned for the second half of the year, as José mentioned.
正如何塞提到的,我們上個月宣布 Enhertu 胃癌呈陽性,併計劃在今年下半年提交監管申請。
In BioPharmaceuticals, we're expecting a regulatory decision for Farxiga's DECLARE label update in China and a decision on the submission of heart failure data for Farxiga in the U.S. in the first half of this year and in the second half of the year in the EU, Japan and China.
在生物製藥方面,我們期待今年上半年和下半年在中國對 Farxiga 的 DECLARE 標籤更新做出監管決定,並在美國對提交 Farxiga 的心力衰竭數據做出決定、日本和中國。
For Lokelma, we're expecting a regulatory decision in Japan for hyperkalemia in the first half of the year.
對於 Lokelma,我們預計今年上半年日本將針對高鉀血症做出監管決定。
And we anticipate a regulatory decision in the U.S. for roxadustat for the treatment of anemia in CKD in the second half of the year.
我們預計美國將在今年下半年針對 roxadustat 治療 CKD 患者的貧血做出監管決定。
In Respiratory, in the second half of the year, again, we anticipate regulatory decisions for Bevespi in China and for PT010 in both the U.S. and the EU, both for the treatment of COPD.
在呼吸方面,我們預計今年下半年將針對中國的 Bevespi 以及美國和歐盟的 PT010 做出監管決定,兩者均用於治療 COPD。
And we anticipate Phase III readouts for tezepelumab in the second half of the year.
我們預計 tezepelumab 的 III 期讀數將在今年下半年公佈。
With so much activity, I'd like to thank everyone here today on the call for their interest and heartfelt thank you to all of our colleagues across R&D for the excellent work they've done in 2019 and they -- I know they will do in 2020.
有了這麼多的活動,我要感謝今天在座的每一個人的興趣,並衷心感謝我們研發部門的所有同事,感謝他們在 2019 年所做的出色工作,他們——我知道他們會做的2020年。
If you can please turn to Slide 41.
如果可以,請轉到幻燈片 41。
Finally, we've updated our epidemiology data pack, which I know many of you are interested in, which can be found in the results and presentations section on astrazeneca.com.
最後,我們更新了我們的流行病學數據包,我知道你們中的許多人都對此感興趣,可以在 astrazeneca.com 的結果和演示部分找到這些數據包。
This update includes epidemiological information for all relevant indications for our marketed medicines and our late-stage pipeline, which we hope will be useful for your modeling.
此更新包括我們已上市藥物和後期管線的所有相關適應症的流行病學信息,我們希望這些信息對您的建模有用。
I'll now hand back to Pascal for his closing comments.
我現在將交還給 Pascal,聽取他的結束評論。
And please turn to Slide 42.
請轉到幻燈片 42。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you, Mene.
謝謝你,梅內。
So we have so much information to share.
所以我們有很多信息要分享。
We're a bit over our time.
我們有點超時了。
So we'll stop here and then go straight to Q&A.
所以我們就到此為止,然後直接進入問答環節。
So we dedicate enough time for your questions because that's really very much what we are here for.
因此,我們會花足夠的時間回答您的問題,因為這正是我們來這裡的目的。
So who wants to get started?
那麼誰想開始呢?
[Andrew]?
[安德魯]?
Unidentified Analyst
Unidentified Analyst
First question for José.
何塞的第一個問題。
Your portfolio is very full, but perhaps some of the programs have not progressed as fast as one might have hoped.
你的作品集很滿,但也許有些項目沒有像人們希望的那樣進展得那麼快。
So when you're thinking through the rate-limiting steps, obviously, you need data, you need to have the right team, sometimes that you have a partner, which can create complexity.
因此,當你考慮限速步驟時,顯然,你需要數據,你需要擁有合適的團隊,有時你需要一個合作夥伴,這會造成複雜性。
Could you help us understand which of those, or resourcing even, explains why some of those drugs?
您能否幫助我們了解其中哪些,甚至資源,可以解釋為什麼其中一些藥物?
And I guess I'm thinking historically of the AKT, the SERD, I mean, although you're moving fast with the second generation, but it just seems the opportunities that exist to prosecute for some of these drugs are perhaps moving on a slower time line than maybe ideally one might have hoped.
我想我是在考慮歷史上的 AKT,SERD,我的意思是,雖然你在第二代方面進展很快,但似乎存在的起訴其中一些藥物的機會可能進展緩慢時間線可能比人們希望的更理想。
So that's the first question.
這是第一個問題。
Second question.
第二個問題。
There's talk about the Grassley bill coming back.
有傳言說格拉斯利法案要回來了。
Could you talk about the extent this is a negative in terms of intensifying pressure on pricing for drugs like Tagrisso as PBMs have more skin in the game in terms of catastrophic coverage and for Calquence?
您能否談談這對加大 Tagrisso 等藥物定價壓力的負面影響,因為 PBM 在災難性覆蓋範圍和 Calquence 方面有更多的利益?
And then finally, on DAPA-HF, assuming you get approval, it seems very likely, what do you think would be the speed of uptake given that cardiologists are unfamiliar with this modality?
最後,在 DAPA-HF 上,假設你獲得批准,似乎很有可能,鑑於心髒病專家不熟悉這種方式,你認為吸收速度是多少?
How do you expect the growth rate of Farxiga to be transformed by DAPA?
您如何看待 DAPA 對 Farxiga 的增長速度的影響?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
So maybe, José, you could cover the first one.
何塞,也許你可以介紹第一個。
And then Ruud, you'll cover the DAPA-HF ramp-up.
然後是 Ruud,你將介紹 DAPA-HF 的升級。
And so I will say a few words on the Grassley deal as well.
因此,我也會就格拉斯利的交易說幾句話。
So go ahead.
所以請繼續。
José Baselga - Executive Vice-President of Oncology Research & Development
José Baselga - Executive Vice-President of Oncology Research & Development
Yes.
是的。
So let me answer to the first question, Andy, that had 5 questions on it.
所以讓我回答第一個問題,安迪,它有 5 個問題。
So I think what you said is absolutely right.
所以我覺得你說的完全正確。
When you have a very diverse pipeline with many, many assets there, you have -- you're facing a number of risks of perhaps not moving things forward as quickly as you could.
當你有一個非常多樣化的管道,其中有很多很多資產時,你有 - 你面臨著許多可能無法盡快推進事情的風險。
I think a big solution to this has been to have a unified oncology R&D organization.
我認為一個重要的解決方案是建立一個統一的腫瘤學研發組織。
And since last year, what we have seen is that we have moved 3 of the Capiva programs all into Phase III.
自去年以來,我們所看到的是,我們已將 3 個 Capiva 項目全部轉移到第三階段。
So Capiva now is into Phase III.
所以 Capiva 現在進入了第三階段。
We are moving this year the SERD program into the late oncology group.
我們今年將 SERD 項目轉移到晚期腫瘤組。
So that's already happening.
所以這已經在發生了。
And we're beginning to see some programs such as the PD-1/CTLA-4 that has been has been accelerated in which, at the same time, the late oncology and the early oncology groups are co-developing the product.
我們開始看到一些項目,如 PD-1/CTLA-4 已經加速,同時,晚期腫瘤學和早期腫瘤學小組正在共同開發該產品。
So what we are anticipating and what we will do is to improve in our process of prioritization.
因此,我們期待和將要做的是改進我們的優先級排序過程。
We have stopped a number of programs last year.
去年我們停止了一些項目。
And by the way, some of them were absolutely probably fine, but they were not top priority.
順便說一句,其中一些絕對可能沒問題,但它們不是最優先考慮的。
We decided to accelerate 6 programs fast and those are moving very quickly.
我們決定快速加速 6 個項目,這些項目進展非常迅速。
So I am very confident that this new R&D organization is enabling this kind of fast-forward decision-making process, and you will see that happening.
所以我非常有信心,這個新的研發組織正在實現這種快速決策過程,你會看到這種情況的發生。
The SERD is a fantastic example of that.
SERD 就是一個很好的例子。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Maybe the one thing I would add to this is -- I mean José is absolutely right, and that's one of the reasons why we realigned ourselves to be faster.
也許我要補充的一件事是——我的意思是何塞是絕對正確的,這就是我們重新調整自己以提高速度的原因之一。
But if Susan was here, Susan Galbraith, she would tell you on the SERD, we had, I mean, a couple of other agents that didn't work, that didn't deliver what we were expecting.
但如果 Susan 在這裡,Susan Galbraith,她會在 SERD 上告訴你,我的意思是,我們有幾個其他代理人沒有工作,沒有達到我們的預期。
So we were refining until we get to -- we got to the agent we have now, which we think is a good one.
所以我們一直在改進,直到我們得到——我們得到了我們現在擁有的代理,我們認為這是一個很好的代理。
So that is also a factor.
所以這也是一個因素。
But it's clear we, certainly in some areas, could have been faster.
但很明顯,我們當然可以在某些領域做得更快。
One of the things we've done lately is we have 3 priorities.
我們最近做的一件事是我們有 3 個優先事項。
One is how do we deliver in the near term these launches and improving our profitability and our cash flow?
一是我們如何在短期內交付這些產品並提高我們的盈利能力和現金流?
Two is how do we accelerate?
二是我們如何加速?
What are the projects in mid-stage development that we are accelerating, not only in oncology but outside oncology?
我們正在加速的中期發展項目有哪些,不僅在腫瘤學領域,而且在腫瘤學以外?
And the third is really 2025 and the big trends in the industry, digital and other technologies, and where do we want to play to be a leader in '25?
第三個是真正的 2025 年以及行業、數字和其他技術的大趨勢,以及我們想在 25 年成為領導者的哪些方面發揮作用?
So Ruud, do you want to cover DAPA and maybe say a few words about the Grassley initiative?
那麼 Ruud,你想報導 DAPA 並談談 Grassley 計劃嗎?
I mean you -- I suppose you're referring to the Senate bill, right, or...
我是說你——我想你指的是參議院法案,對吧,或者……
Unidentified Analyst
Unidentified Analyst
Yes, yes.
是的是的。
Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit
Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit
Yes.
是的。
So first, a few words about the HF opportunity.
所以首先,關於 HF 機會的幾句話。
I think it's very substantial.
我認為這是非常可觀的。
You've all seen the results.
你們都看到了結果。
We were granted priority review.
我們獲得了優先審評。
So as an organization, we are very bullish about the potential.
因此,作為一個組織,我們非常看好潛力。
And equally, of course, it will take time for cardiologists in order -- as you refer, Andrew, in order to embrace these products for -- especially the non-diabetic patient population.
同樣,當然,心髒病專家需要時間——正如你所指的,安德魯,以便接受這些產品——尤其是非糖尿病患者群體。
What is helping us well at the moment is that guideline committees around the world are very progressive in order to include it in the guidelines.
目前對我們有幫助的是,世界各地的指南委員會都非常積極地將其納入指南。
There's a lot of initiatives ongoing in order to get that done.
為了完成這項工作,正在進行許多舉措。
So all in all, we feel comfortable that this will be a very important growth driver.
所以總而言之,我們感到很舒服,這將是一個非常重要的增長動力。
Specifically, in the United States, we have launched the DECLARE indication, which is the prevention of heart failure, only a few months ago.
具體來說,在美國,我們幾個月前才推出了預防心力衰竭的DECLARE適應症。
And clearly, at the level of the cardiologists, we -- although the numbers, the absolute numbers are small, we see quite an impressive growth of that segment.
很明顯,在心髒病專家的層面上,我們——儘管數量,絕對數量很小,但我們看到該部分的增長相當可觀。
So time will tell.
所以時間會證明一切。
But of course, we are very committed in order to make this a great success because of the huge benefits for patients in -- with heart failure.
但是,當然,我們非常致力於使它取得巨大成功,因為它對患有心力衰竭的患者有巨大的好處。
And then finally, the Senate bill in itself, and we spoke about that a couple of times in the past, Andrew, and personally, I don't think a lot has changed.
最後,參議院法案本身,我們過去曾多次談過這個問題,安德魯,就我個人而言,我認為沒有太大變化。
Every week, every second week, there is a new level of speculation in the U.S. around this bill.
每週,每兩週,美國都會圍繞該法案進行新的猜測。
There are a couple of elements of the bill.
該法案有幾個要素。
We clearly support the out of pocket -- capping of the out-of-pocket cost clearly is something we can support.
我們顯然支持自付費用——顯然我們可以支持對自付費用設置上限。
The impact, especially on our oncology products or Part D products like Calquence and Tagrisso can be, to some extent, substantial equally.
這種影響,尤其是對我們的腫瘤學產品或 Calquence 和 Tagrisso 等 D 部分產品的影響,在某種程度上可能是同等重要的。
It has also a couple of advantage for the BioPharma business.
它對生物製藥業務也有一些優勢。
So as an organization, I think it's a balanced impact for us at this stage.
因此,作為一個組織,我認為在現階段這對我們來說是一種平衡的影響。
But I close by saying it's far too early to speculate about what is really going to happen there.
但我最後要說的是,現在推測那裡真正會發生什麼還為時過早。
Sachin Jain - MD
Sachin Jain - MD
Sachin Jain, Bank of America.
美國銀行的 Sachin Jain。
A question on guide and then a question on some launches.
一個關於指南的問題,然後是一個關於一些發布的問題。
So while '19 sales growth is very strong, some of the key product drivers missed and you've moved away from product sales growth, so there's obviously some level of nervousness.
因此,雖然 19 年的銷售增長非常強勁,但錯過了一些關鍵的產品驅動因素,並且您已經遠離了產品銷售增長,因此顯然存在一定程度的緊張情緒。
I wonder if you can give some color around the revenue guide.
我想知道您是否可以在收入指南周圍添加一些顏色。
What's your level of comfort with product sales at roughly double-digit growth ex the China impact?
排除中國的影響,您對產品銷售額以大約兩位數的速度增長感到滿意嗎?
Or is collaboration revenue a disproportionate driver of that total revenue growth?
還是協作收入是總收入增長的不成比例的驅動因素?
Then on China, have you seen any impact to date?
那麼在中國,你看到了迄今為止的任何影響嗎?
And any color you can give as to what is assumed within the guidance from an EPS perspective, just to give some color.
從 EPS 的角度來看,您可以給出關於指南中假設的任何顏色,只是為了給出一些顏色。
And then on launches, David, you mentioned positive early indicators for Calquence in first-line CLL and for Enhertu.
然後在發佈時,大衛,你在一線 CLL 和 Enhertu 中提到了 Calquence 的積極早期指標。
I wonder if you can give some more color on that for both of those products.
我想知道您是否可以為這兩種產品提供更多顏色。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Let me just ask Marc to comment on guidance, but I just want to make sure there's no doubt there's absolutely zero nervousness about product sales.
讓我請 Marc 對指南發表評論,但我只想確保毫無疑問,對產品銷售的緊張程度絕對為零。
The reason we have moved to total revenue is very simple, is we are -- I mean we went through a period when driving top lines, new product sales was key, but we're moving into a period where essentially our long-term strategy of collaboration is starting to have an impact.
我們轉向總收入的原因很簡單,我們是——我的意思是我們經歷了一個推動收入增長的時期,新產品銷售是關鍵,但我們正在進入一個基本上我們的長期戰略的時期協作開始產生影響。
So we have revenue coming from Enhertu, from roxadustat from a number of -- Lynparza, a number of collaborations.
所以我們有來自 Enhertu 的收入,來自 roxadustat 的一些—— Lynparza ,一些合作。
And we need to make sure this revenue is recognized in our total revenue.
我們需要確保這筆收入在我們的總收入中得到確認。
On top of it, on a very practical front, from a governance viewpoint, so our Remuneration Committee wants to have a single number that governance groups and shareholders can recognize.
最重要的是,從治理的角度來看,在非常實際的方面,我們的薪酬委員會希望擁有一個治理團體和股東可以認可的單一數字。
So we said, "Okay, we're going to pick one single number, what should it be?" We picked total revenue.
所以我們說,“好吧,我們要選擇一個號碼,它應該是什麼?”我們選擇了總收入。
So -- but there is absolutely zero anxiety about product sales.
所以——但對產品銷售的焦慮絕對為零。
Marc, do you want to...
馬克,你想...
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
No.
不。
I mean it's absolutely correct.
我的意思是它是絕對正確的。
I think the 2 lines will, in fact, grow in unison.
我認為這兩條線實際上會同步增長。
The growth rate will be very similar, whether you look at total revenue of -- or product sales.
無論您是看總收入還是產品銷售額,增長率都將非常相似。
But we had, as Pascal said, we had to define one variable that we would consider for our guidance, and we decided to take the most complete information on total revenues.
但是,正如帕斯卡所說,我們不得不定義一個我們將考慮用於指導的變量,並且我們決定獲取有關總收入的最完整信息。
But when you see the numbers, they are very, very similar.
但是當你看到這些數字時,它們非常非常相似。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
I would also add that, I mean, personally, historically, I thought revenues like Enhertu and others will be recognized in product sales, but accounting guidelines are such that basically, it's recognized in revenue.
我還要補充一點,我的意思是,就個人而言,從歷史上看,我認為像 Enhertu 和其他人這樣的收入將在產品銷售中得到確認,但會計準則基本上是在收入中得到確認。
But at the end of the day, those are product sales, right?
但歸根結底,這些都是產品銷售,對吧?
And we want those revenue to be recognized.
我們希望這些收入得到認可。
So it's pretty simple.
所以這很簡單。
Dave, do you want to cover Enhertu?
戴夫,你想報導恩赫圖嗎?
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
Sure.
當然。
So Sachin, thanks for the question.
所以薩欽,謝謝你的提問。
Maybe a bit more depth on Calquence since we've had more time in the market on that one.
也許對 Calquence 有更深入的了解,因為我們在市場上花的時間更多。
With Calquence, we are really pleased with the launch.
我們對 Calquence 的發布感到非常滿意。
We look at the metric that's most relevant as BTKi class new starts because that's really where we think we've got the most opportunity to make impact.
我們查看與 BTKi 類新開始最相關的指標,因為這確實是我們認為我們最有機會產生影響的地方。
And BTKi has been well established in CLL.
而 BTKi 已經在 CLL 中得到很好的應用。
So we really look at how we've penetrated into that.
所以我們真的看看我們是如何滲透到這一點的。
December is the first full month where we've been able to see in 2019 the performance.
12 月是我們能夠看到 2019 年表現的第一個完整月份。
And I think you've got to look at the composition.
我認為你必須看一下作文。
So first, we saw good growth in the new patient starts, and you all have the IQVIA data and can see what you see out of that.
所以首先,我們看到新患者開始有良好的增長,你們都有 IQVIA 數據,可以看到你從中看到的東西。
I think the part that we see that's important is the composition of those starts.
我認為我們看到的重要部分是這些開始的組成。
So in December, the composition of that starts, I would say, is about 40% to 50% is late line, which is good in the sense that we have an expectation that we are going to get ibrutinib-intolerant patients that are going to be switching and moving over, and that's predominantly what this patient population is and we expect that to be part of the business for the long term.
所以在 12 月,開始的組成,我想說,大約 40% 到 50% 是晚線,這在某種意義上是好的,因為我們期望我們將得到對 ibrutinib 不耐受的患者,這些患者將正在轉換和轉移,這就是這個患者群體的主要特徵,我們希望這將成為長期業務的一部分。
The balance of it, obviously, would have been naive patients, new to BTKi.
顯然,它的平衡是天真的患者,對 BTKi 不熟悉。
As we look at the January data and recognizing it as sort of an early view into it, we're seeing that the number of third-line patients within those new starts is coming down after a very significant increase in December.
當我們查看 1 月份的數據並將其視為一種早期觀點時,我們看到這些新開始的三線患者人數在 12 月份大幅增加後正在下降。
This is consistent also with what we saw in MCL, now that bolus or warehousing, depending upon the language, and that set of patients with latent dissatisfaction with the tolerability of their existing medicines switching over.
這也與我們在 MCL 中看到的一致,現在推注或倉儲,取決於語言,以及那些對現有藥物的耐受性有潛在不滿的患者轉而使用。
And so I think that we're encouraged to see that the naive patient population is growing in terms of new patient starts on Calquence, and we look forward to continuing to watch this trend.
因此,我認為我們很高興看到,就新患者開始使用 Calquence 而言,天真的患者人數正在增長,我們期待繼續關注這一趨勢。
But all signs are quite positive there.
但那裡的所有跡像都非常積極。
Enhertu, just very quickly, we see early adoption taking place, early booking of sales coming through.
Enhertu,很快,我們就看到了早期採用,以及早期的銷售預訂。
Anecdotally, we're getting very good receptivity from physicians.
有趣的是,我們從醫生那裡得到了很好的接受度。
We're getting into seeing accounts.
我們正在查看帳戶。
We're getting listed in EMRs rapidly.
我們正在迅速列入電子病歷。
We're seeing pharmacies open us up so that we sit on formulary.
我們看到藥房對我們敞開心扉,讓我們坐在處方集上。
All of these things happen because physicians have interest in prescribing the drug.
所有這些事情的發生都是因為醫生有興趣開藥方。
And when that happens, things start moving quickly.
當這種情況發生時,事情開始迅速發展。
It's too early to know how much of the sales that you've seen is inventory build versus demand, but we think that we've got some good positive indicators.
現在要知道您所看到的銷售額中有多少是庫存增加與需求之間的關係還為時過早,但我們認為我們已經獲得了一些良好的積極指標。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Dave.
謝謝,戴夫。
Your third question was China.
你的第三個問題是中國。
Can you just rephrase it?
你能改一下嗎?
Sachin Jain - MD
Sachin Jain - MD
Have you seen any impact today?
你今天看到任何影響了嗎?
And roughly, you've mentioned a few months within guidance.
粗略地說,你在指導中提到了幾個月。
How does that translate on EPS?
這在 EPS 上如何轉化?
Any more color you can give?
你能再給點顏色嗎?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Right.
正確的。
I mean maybe what we could do is ask Leon to comment, generally speaking.
我的意思是,一般來說,也許我們可以請 Leon 發表意見。
He is on the ground, and I talk to him almost on a daily basis.
他在實地,我幾乎每天都和他交談。
But of course, he's on the ground.
但當然,他在地面上。
So Leon, do you want to comment on coronavirus and the impact you've seen so far or you expect?
那麼 Leon,你想評論一下冠狀病毒以及你目前看到的或你預期的影響嗎?
Leon Wang - Executive VP of International & China President
Leon Wang - Executive VP of International & China President
Yes.
是的。
I think the -- of course, a lot of media reports.
我認為 - 當然,很多媒體報導。
But I think the situation outside Hubei and Wuhan, Hubei province is improving.
但我認為湖北和湖北省武漢市以外的情況正在好轉。
I think we cannot speculate how long will this epidemic last.
我認為我們無法推測這種流行病會持續多久。
I think it will still be the next few months.
我認為這仍將是未來幾個月。
Right now, the impact is mainly the -- our salespeople cannot easily visit the hospital and access to the health care professional because doctors, especially some of the specialty, are focusing on fighting the epidemic.
目前,影響主要是——我們的銷售人員無法方便地去醫院和接觸醫療保健專業人員,因為醫生,尤其是一些專科的醫生正在專注於抗擊疫情。
So I think all these disruptions are quite temporary.
所以我認為所有這些中斷都是暫時的。
And patients now, really instead of visiting hospital, they go to pharmacy to review prescription and also they go online to consult doctors and also to get their prescription reviewed.
現在的病人,他們真的不用去醫院,而是去藥房複查處方,他們還會上網諮詢醫生,讓他們的處方復查。
So that we see a trend of such.
這樣我們就看到了這樣的趨勢。
And while the impact is temporary, but I still would like you to focus on the positive side.
雖然影響是暫時的,但我仍然希望你關注積極的一面。
I think AstraZeneca is the most widely expanded coverage company by rural community, hospital, retail, we are #1 in the emerging hospital.
我認為阿斯利康是農村社區、醫院、零售覆蓋範圍最廣的公司,我們在新興醫院中排名第一。
And we have a lot of NRDL reimbursement inclusion last year and new indication approval.
去年我們有很多 NRDL 報銷納入和新適應症批准。
And we have also 4 new product approval in 2019.
2019年我們還有4個新產品批准。
And AstraZeneca is also very strong in digital promotion and retail pharmacy promotion and also online pharmacy collaboration.
而阿斯利康在數字推廣和零售藥店推廣以及在線藥店合作方面也非常強大。
And today, we started the first prescription of Imfinzi patients in China.
而今天,我們在中國開始了第一張 Imfinzi 患者的處方。
So even during the epidemic, everyone, logistics side, supply chain side and the operation, manufacturing and head office people and a lot of functions are already working, starting from already beginning of last week.
所以即使在疫情期間,每個人,物流方面,供應鏈方面以及運營,製造和總部人員以及許多職能部門都已經在工作,從上週開始就已經開始了。
So I think AstraZeneca is quite a resilient organization.
所以我認為阿斯利康是一個很有彈性的組織。
The whole team is behind making sure employee is safe and also doctors are supported and the business interruption is minimized.
整個團隊都在背後確保員工安全,醫生得到支持,業務中斷最小化。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thank you.
謝謝你。
Richard J. Parkes - Director
Richard J. Parkes - Director
Richard Parkes from Deutsche Bank.
德意志銀行的理查德·帕克斯。
Firstly, just a follow-up on Sachin's question about some of the key products being slightly below expectations in the fourth quarter.
首先,只是對 Sachin 關於第四季度一些關鍵產品略低於預期的問題的後續行動。
I think if you look at consensus numbers, a lot of that was slightly slower, your traction in Europe.
我想如果你看一下共識數字,其中很多都稍微慢一些,你在歐洲的吸引力。
So could you just talk about your level of confidence in driving uptake in those territories?
那麼,您能否談談您對在這些地區推動採用的信心程度?
Is it just a factor of timing in terms of reimbursement?
就報銷而言,這只是時間因素嗎?
Or have you been facing more challenging access than expected?
或者您是否面臨比預期更具挑戰性的訪問?
Maybe you could talk about what -- are you having to give more price than anticipated, particularly things like Tagrisso where there's already a price in the second-line setting?
也許你可以談談什麼——你是否必須給出比預期更多的價格,特別是像 Tagrisso 這樣的二線設置已經有價格的東西?
Second question, one of your competitors has been very vocal about the preferential PK characteristics of its PARP inhibitor in mice.
第二個問題,您的一個競爭對手一直非常直言不諱地談論其 PARP 抑製劑在小鼠中的優先 PK 特性。
I just wondered if you could comment on your view on the clinical relevance of those findings.
我只是想知道您是否可以評論您對這些發現的臨床相關性的看法。
And then third question, just on Enhertu and the ILD incidents.
然後是第三個問題,關於 Enhertu 和 ILD 事件。
Obviously, I think most of us view that -- the instance of serious ILD cases is a key gating factor to earlier use of the drug and you've tightened up the risk management.
顯然,我認為我們大多數人都認為——嚴重 ILD 病例的實例是早期使用該藥物的關鍵門控因素,你已經加強了風險管理。
Can you talk about to what degree you can back-test whether that's working by looking at the overall ILD rate in the ongoing clinical program?
你能談談你可以在多大程度上通過查看正在進行的臨床項目中的總體 ILD 率來回測這是否有效?
I know a lot of that's blinded, but I'm sure you can see unblinded incidence rates.
我知道很多都是盲的,但我相信你可以看到非盲的發病率。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
That's good.
那挺好的。
So let me just suggest that -- Dave, you could cover the first question because probably, I guess what people have in mind is Tagrisso and Imfinzi in Q4.
所以讓我建議——戴夫,你可以回答第一個問題,因為我猜人們可能想到的是第四季度的 Tagrisso 和 Imfinzi。
Outside of those 2, I mean we had a one-off cost to net adjustment on Farxiga, but I think maybe the softness, if you want to call it this way, relate to Tagrisso and Imfinzi and nothing that we didn't expect before.
在這 2 個之外,我的意思是我們對 Farxiga 進行了淨調整的一次性成本,但我認為也許軟性,如果你想這樣稱呼它,與 Tagrisso 和 Imfinzi 相關,並且沒有我們之前沒有預料到的.
So the key question is, beyond the U.S., what happens outside of the U.S. So Dave, do you want to cover this one?
所以關鍵問題是,在美國之外,美國以外會發生什麼所以戴夫,你想報導這個嗎?
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
Yes, sure.
是的,當然。
So maybe starting first with Tagrisso.
所以也許首先從 Tagrisso 開始。
And Richard, you asked a bit about Europe, but I think it's worth starting on the U.S. and I think that, that's an important starting point.
理查德,你問了一些關於歐洲的問題,但我認為值得從美國開始,我認為這是一個重要的起點。
So Tagrisso in the U.S., we have now established as standard of care with Tagrisso in the U.S. And owing to that now, we've got about 2/3 of all starts are on Tagrisso.
所以美國的 Tagrisso,我們現在已經在美國建立了 Tagrisso 的護理標準。由於現在,我們有大約 2/3 的開始是在 Tagrisso 上。
So we really have now gotten to a point where the growth that we expect going forward on Tagrisso in the U.S. sequentially would be incremental growth.
因此,我們現在確實已經達到了這樣一個地步,即我們預計美國 Tagrisso 的增長將是增量增長。
With that said, we did see incremental growth in the U.S. in terms of demand in the fourth quarter.
話雖如此,我們確實看到美國第四季度的需求出現增量增長。
You'll recall, in the third quarter, I talked about the growth between Q2 and Q3, which was $50 million on Tagrisso in the U.S. that about half of that was inventory and gross to net.
你會記得,在第三季度,我談到了第二季度和第三季度之間的增長,美國 Tagrisso 的增長為 5000 萬美元,其中大約一半是庫存和毛淨收入。
And we definitely saw that we -- saw a drawdown in inventory and a readjustment to gross to net in Q4 that explains certainly some of that.
而且我們確實看到我們 - 看到第四季度庫存減少和毛額調整為淨額,這肯定解釋了其中的一些原因。
But we had mid-single-digit demand growth from TRxs and from duration of therapy in Q4 on Tagrisso.
但我們在 Tagrisso 的第四季度從 TRxs 和治療持續時間中獲得了中個位數的需求增長。
And we expect that to continue on a fairly substantial base in the U.S. and Japan into next year.
我們預計這種情況將在美國和日本的相當大的基礎上持續到明年。
And then we've got the other 62 markets that are progressing along quite nicely with Tagrisso in terms of the reimbursement decisions.
然後我們有其他 62 個市場在報銷決策方面與 Tagrisso 進展順利。
And that includes places like Korea, Taiwan, still here in the U.K., markets that have substantial sales that are behind it.
這包括韓國、台灣、英國等地,這些市場的銷售量很大。
On Imfinzi, I think Imfinzi, again, as I mentioned in my comments, and I won't repeat, I do think that we're at a spot in the U.S. where we've gotten ourselves pretty well penetrated into that Stage III setting.
在 Imfinzi 上,我認為 Imfinzi,正如我在評論中提到的,我不會重複,我確實認為我們在美國處於一個我們已經很好地滲透到第三階段設置的地方.
As I look at the growth drivers for Imfinzi in 2020, really, it's, ex U.S., continued opportunity to drive on PACIFIC.
當我審視 Imfinzi 在 2020 年的增長動力時,實際上,在美國之外,它是繼續推動 PACIFIC 發展的機會。
Keep in mind that 70% of the sales on Imfinzi today are in the U.S. I would say that the composition that we might expect is more like 60-40 or 55-45, if you take a look at the other brands.
請記住,今天 Imfinzi 70% 的銷售額在美國。如果您看一下其他品牌,我會說我們可能期望的成分更像是 60-40 或 55-45。
So it gives reason to believe that we have an opportunity to drive outside of the U.S. We just got approval in China.
所以有理由相信我們有機會在美國以外的地方開車。我們剛剛在中國獲得批准。
So -- and Leon mentioned the first patient infused there.
所以——萊昂提到了第一個在那裡輸液的病人。
So that's not even in the performance yet.
所以這甚至還沒有出現在表演中。
And then, of course, in the U.S., CASPIAN is the most near-term priority review.
然後,當然,在美國,CASPIAN 是最近期的優先審查。
We're getting ready for launches on that in the first half.
我們正準備在上半年推出。
And I think that with competition likely being limited to just the Roche molecule and not having 3 competitors in the space, I think that's also something that gives us some cause for optimism on our opportunity to grow there.
而且我認為,由於競爭可能僅限於羅氏分子,而在該領域沒有 3 個競爭對手,我認為這也讓我們有理由對我們在那裡發展的機會感到樂觀。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, David.
謝謝,大衛。
José, do you want to cover the PARP question, the preclinical data?
José,你想討論 PARP 問題,即臨床前數據嗎?
And also the ILD Enhertu?
還有ILD Enhertu?
José Baselga - Executive Vice-President of Oncology Research & Development
José Baselga - Executive Vice-President of Oncology Research & Development
Yes.
是的。
Well, I don't feel comfortable commenting on mice PK data published in Oncotarget, I don't.
好吧,我不願意對發表在 Oncotarget 上的小鼠 PK 數據發表評論,我沒有。
But I do feel comfortable discussing the clinical data and I think that's very important.
但我確實很樂意討論臨床數據,我認為這非常重要。
If you look -- and again, you need to be careful in comparing different trials.
如果你再看一次,你需要小心比較不同的試驗。
But if you look at the data that we achieved with PAOLA, in our PAOLA population, we achieved more than 2 years of progression-free survival in the first-line setting, and this is totally unprecedented.
但是,如果您查看我們使用 PAOLA 獲得的數據,在我們的 PAOLA 人群中,我們在一線環境中實現了超過 2 年的無進展生存期,這完全是前所未有的。
So I think that we can get tight on PKs and we can get tight on a number of measures such as HR, but at the end of the day, I think when a patient comes to your clinic, what you're asking about is, how long will I have disease without coming back?
所以我認為我們可以在 PK 上收緊,我們可以在人力資源等一些措施上收緊,但歸根結底,我認為當病人來到你的診所時,你要問的是,得病多久不回來?
And I think when you look at the absolute number, which is what matters to any patient and to any physician, the PAOLA data set is the strongest overall.
而且我認為,當您查看絕對數字時,這對任何患者和任何醫生都很重要,PAOLA 數據集總體上是最強的。
A point that you cannot compare different studies is that, for example, when you look at our population in PAOLA that is HRD-proficient and we looked at the same population that was part of the PRIMA study.
您無法比較不同研究的一點是,例如,當您查看 PAOLA 中精通 HRD 的人口時,我們查看的是 PRIMA 研究中的同一人口。
So we basically -- we took our HRD-proficient patients that fulfill the criteria of the PRIMA population.
所以我們基本上——我們接受了符合 PRIMA 人群標準的 HRD 熟練患者。
We observed also tremendous benefit.
我們也觀察到巨大的好處。
So the PFS in the olaparib plus bevacizumab arm was 22 months, and it was 16 months on the bevacizumab arm alone.
因此,奧拉帕尼聯合貝伐珠單抗組的 PFS 為 22 個月,而單獨使用貝伐珠單抗組為 16 個月。
And this is a data set that was presented at the recent ASCO meeting.
這是在最近的 ASCO 會議上展示的數據集。
So I think we feel incredibly confident that olaparib is the best in class.
所以我認為我們非常有信心奧拉帕尼是同類產品中最好的。
We have the lower rate of discontinuation.
我們的停藥率較低。
We have an unprecedented clinical benefit in terms of duration.
我們在持續時間方面獲得了前所未有的臨床益處。
So this is the best-in-class agent that there is, and we feel very, very excited by it and looking forward to be able to offer these to patients as soon as possible.
所以這是目前最好的藥物,我們對此感到非常非常興奮,並期待能夠盡快將這些藥物提供給患者。
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
And we have Marc here as well, if anyone wants questions afterwards on PARP specifically.
我們也有 Marc,如果有人想在之後專門針對 PARP 提問。
José Baselga - Executive Vice-President of Oncology Research & Development
José Baselga - Executive Vice-President of Oncology Research & Development
Marc is there.
馬克在那裡。
Yes, Marc, yes.
是的,馬克,是的。
Now on the Enhertu ILD, since May, we have not observed a single case, thank God, of ILD Grade 5 in our studies of 5.4 milligrams.
現在,在 Enhertu ILD 上,自 5 月以來,感謝上帝,在我們對 5.4 毫克的研究中,我們沒有觀察到一個 ILD 5 級病例。
So -- and we're enrolling a lot of patients into the clinical trials.
所以 - 我們正在招募很多患者參加臨床試驗。
There's no question that the fact that physicians are aware and patients are aware of ILD and that we have instituted real-time guidance on how to treat ILD is making a progress.
毫無疑問,醫生和患者都知道 ILD,而且我們已經制定了關於如何治療 ILD 的實時指導,這一事實正在取得進展。
We don't have yet data on real time.
我們還沒有實時數據。
We don't have that, but we are looking at this.
我們沒有那個,但我們正在研究這個。
I think, to me, a very reassuring piece of information is that we are enrolling successfully patients into our post-PCR study, which is an early disease study, and enrollment is going well.
我認為,對我來說,一條非常令人放心的信息是,我們正在成功招募患者進入我們的 PCR 後研究,這是一項早期疾病研究,招募進展順利。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, José.
謝謝,何塞。
Let's take an online question.
我們來看一個在線問題。
Tim Anderson, Tim, do you want to go ahead?
蒂姆安德森,蒂姆,你想繼續嗎?
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
A couple of questions, please.
請問幾個問題。
Tagrisso, just to clarify, I think in prepared remarks, I heard you say that you expect NRDL for first-line in China, which would imply approval of first-line in China, or I guess at least reimbursement opening up for the product.
Tagrisso,我想澄清一下,我想在準備好的發言中,我聽到你說你希望國家醫保目錄在中國成為一線,這意味著在中國一線獲得批准,或者我想至少開放該產品的報銷。
I'm referring to the Asian patient subset of FLAURA where OS didn't hit.
我指的是 FLAURA 的亞洲患者子集,其中 OS 沒有受到影響。
So are you saying that everything's all clear there and you expect there's not going to be any reimbursement hurdles?
那麼你是說那裡一切都清楚並且你希望不會有任何報銷障礙?
Second question, not an exciting product necessarily, but Pulmicort in China, we learned recently that, that is the biggest single drug in China of all drug companies, hitting $1 billion, still growing, yet it's off-patent.
第二個問題,不一定是激動人心的產品,但是普米克在中國,我們最近了解到,這是中國所有藥企中最大的單一藥物,達到10億美元,還在增長,但專利到期了。
You may have seen our research recently digging into how long this lasts for, because a lot of generic companies are circling.
您可能已經看到我們最近的研究正在深入研究這種情況會持續多久,因為很多仿製藥公司都在盤旋。
It seems to us maybe you have a few years where there is no generic threat, there's no VBP risk.
在我們看來,也許你有幾年沒有通用威脅,沒有 VBP 風險。
Hoping you can tell us your internal expectations on timing for this potentially happening in China.
希望您能告訴我們您內部對這種可能在中國發生的時間的預期。
How long will it continue to grow for?
它會持續增長多久?
And then just last question.
然後是最後一個問題。
Tezepelumab, only a brief mention today.
Tezepelumab,今天只簡單提一下。
We get Phase III data reading out this year.
我們今年獲得了 III 期數據。
Phase II data looked solid, especially in the noneosinophilic asthma.
II 期數據看起來可靠,尤其是在非嗜酸性粒細胞性哮喘方面。
Your level of confidence in that program replicating what was seen in Phase II?
您對該計劃複製第二階段所見內容的信心程度?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Thanks, Tim.
謝謝,蒂姆。
Yes, tezepelumab, we didn't talk much about, but as you can see, we had -- as you saw, we have so much to share that we were a bit over time anyway, even without talking about teze.
是的,tezepelumab,我們沒有談論太多,但正如你所看到的,我們有——正如你所看到的,我們有太多要分享的東西,以至於我們已經過了一段時間,甚至沒有談論 teze。
So Tagrisso, let me cover that quickly.
所以 Tagrisso,讓我快速介紹一下。
We've never said it would be easy.
我們從未說過這會很容易。
Reimbursement is always a challenge.
報銷始終是一個挑戰。
And in China, essentially, we will start this process this year.
在中國,從本質上講,我們將在今年開始這個過程。
And if we were successful, the reimbursement would be next year.
如果我們成功了,報銷將在明年進行。
But we've always said moving into first line will be more challenging because, of course, you have more patients, more budget impact and that's a challenge.
但我們一直說進入一線將更具挑戰性,因為當然,你有更多的病人,更多的預算影響,這是一個挑戰。
So that's basically all we could say about Tagrisso.
所以這基本上就是我們對 Tagrisso 所能說的全部。
Pulmicort, maybe Leon, if you want to comment on it because one of the things in this -- with this pandemic, by the way -- or epidemic, sorry, is that this is likely to push patients to use more home nebulization.
Pulmicort,也許是 Leon,如果你想對此發表評論,因為其中一件事 - 順便說一句 - 或流行病,抱歉,這可能會促使患者使用更多的家庭霧化。
So in that case, it sort of goes in our favor of diversifying the base of Pulmicort.
所以在那種情況下,它有點有利於我們使 Pulmicort 的基礎多樣化。
Leon, do you want to say a few words about Pulmicort in China and your prospects there?
Leon,你想談談普米克在中國的前景嗎?
Leon Wang - Executive VP of International & China President
Leon Wang - Executive VP of International & China President
Yes.
是的。
I think, Tim, it's a very good question.
我認為,蒂姆,這是一個很好的問題。
I think Pulmicort is one of the biggest product in our China portfolio.
我認為 Pulmicort 是我們中國產品組合中最大的產品之一。
It's around 20% of our total business.
它約占我們總業務的 20%。
And I think I cannot speculate on when the generic will come.
而且我認為我無法推測仿製藥何時會出現。
And I think it's a nebulized product and that there is a special guidance being reviewed by China NMPA and CDE about the -- what kind of quality standard, nebulized form of drug should reach before they can get approval as a generic.
我認為這是一種霧化產品,中國 NMPA 和 CDE 正在審查關於——什麼樣的質量標準,霧化形式的藥物在獲得仿製藥批准之前應該達到什麼樣的質量標準。
So I think we -- first, we will see a generic coming.
所以我認為我們 - 首先,我們將看到一個通用的到來。
And then is when -- that you have enough generic, there will be VBP.
然後是——當你有足夠的通用性時,就會有 VBP。
And then thirdly is the generic needs to have enough capacity and continue consistent quality.
然後第三是通用需要有足夠的容量和持續一致的質量。
It's -- actually, our quality standard is quite high, and we'll be -- we are quite confident about our capacity and quality standard.
它——實際上,我們的質量標準很高,而且我們將會——我們對我們的能力和質量標準非常有信心。
I think even though it might come at some time point, I think we are now focusing also a lot of Symbicort penetration -- inhalation.
我認為即使它可能會在某個時間點出現,我認為我們現在也關注很多 Symbicort 滲透——吸入。
So Symbicort is still having huge potential in China, and that we are launching mild asthma indication for Symbicort.
所以Symbicort在中國還是有巨大潛力的,我們正在推出Symbicort的輕度哮喘適應症。
And we now -- last December, we get also approval for Breast03, the triple, getting to the huge COPD untapped potential.
而我們現在 - 去年 12 月,我們還獲得了 Breast03 的批准,三重,獲得巨大的 COPD 未開發潛力。
And the China government also include asthma and COPD recently into the chronic disease category, together with high blood pressure and diabetes.
中國政府最近還將哮喘和慢性阻塞性肺病與高血壓和糖尿病一起納入慢性病範疇。
So I think there are a lot of positives and Symbicort also getting to EDL category, together with Pulmicort, removing limitation.
所以我認為有很多積極因素,Symbicort 也進入了 EDL 類別,與 Pulmicort 一起,消除了限制。
So I think in the Respiratory portfolio, we have also Bevespi getting approval in moderate COPD.
所以我認為在呼吸產品組合中,我們也有 Bevespi 在中度 COPD 中獲得批准。
So I think we have a lot of positives to push on the inhaled part of the business in order to mitigate this Pulmicort mid- to long-term risk.
因此,我認為我們有很多積極因素可以推動業務的吸入部分,以減輕 Pulmicort 的中長期風險。
And also, we have a lot of other new excitement launch -- new product launches like roxa, Lokelma also get approval.
而且,我們還有很多其他令人興奮的新產品發布——像 roxa、Lokelma 這樣的新產品發布也獲得了批准。
Roxa get not only approval but also reimbursement inclusion.
Roxa 不僅獲得批准,還獲得報銷。
So I think we have many more cards in hand in order to mitigate this risk.
所以我認為我們手頭有更多的牌可以降低這種風險。
So we are ready.
所以我們準備好了。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Excellent.
出色的。
Do you want to say a few words about teze, Mene?
你想說幾句關於 teze 的事嗎,Mene?
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
Just that I agree that the data was very strong in the Phase II study.
只是我同意 II 期研究中的數據非常強大。
And I think both internally and externally, when you speak to opinion leaders, we're very excited about seeing the Phase III data.
我認為在內部和外部,當你與意見領袖交談時,我們對看到 III 期數據感到非常興奮。
And if positive and if we're able to repeat what we see in Phase II, have the opportunity to really broaden out beyond this disease in asthma, which I think is going to be tremendously exciting now that biologics is starting to take hold.
如果是積極的,如果我們能夠重複我們在第二階段看到的,就有機會真正擴大到哮喘以外的這種疾病,我認為現在生物製劑開始站穩腳跟,這將是非常令人興奮的。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
But we have to wait, yes?
但我們必須等待,是嗎?
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
Yes.
是的。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
One question in the room?
房間裡的一個問題?
Okay, yes.
好的,是的。
Can we get another mic there so we don't spend too much time waiting for mics?
我們可以在那裡再拿一個麥克風,這樣我們就不會花太多時間等待麥克風嗎?
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
Keyur Parekh at Goldman Sachs.
高盛的 Keyur Parekh。
Two questions, please.
請教兩個問題。
First one, Pascal, in 2019, about 45% to 50% of your growth top line product sales came from China.
第一個,Pascal,在 2019 年,您增長的頂級產品銷售額中約有 45% 至 50% 來自中國。
As you think about 2020 and geographic spread or breadth of growth, how much of that high single, low double-digit growth are you anticipating kind of coming from China?
當您考慮 2020 年和地理分佈或增長廣度時,您預計高個位數、低兩位數的增長中有多少來自中國?
That's question #1.
這是問題#1。
And then secondly, Marc, in your prepared remarks, you spoke about the other operating income continuing to be a significant part of your income statement in 2020 and beyond.
其次,馬克,在你準備好的發言中,你談到了其他營業收入在 2020 年及以後繼續成為你損益表的重要組成部分。
From a quantity perspective, should we think of it as broadly being in line with 2019, above, below 2019?
從數量上看,我們是否應該認為它與2019年大致一致,高於2019年,低於2019年?
Any sense there would be helpful.
任何感覺都會有所幫助。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
So Marc, do you want to cover the second question?
馬克,你想回答第二個問題嗎?
Marc Dunoyer - CFO & Executive Director
Marc Dunoyer - CFO & Executive Director
Yes.
是的。
So I think the -- you saw in 2019 a very dramatic reduction in collaboration revenue, in the sum of collaboration revenue and other income.
所以我認為 - 你在 2019 年看到合作收入、合作收入和其他收入的總和大幅減少。
I wanted to be very transparent on the trend for 2020 and not have people believe that this trend of minus 25% every year was going to continue.
我想對 2020 年的趨勢非常透明,而不是讓人們相信這種每年負 25% 的趨勢會持續下去。
This is why I indicated that we would still have other income in 2020 and also give you one illustration, or one example, of why this is going to continue.
這就是為什麼我表示我們在 2020 年仍然會有其他收入,並且還給你一個例子,或者一個例子,說明為什麼這會繼續下去。
For instance, when we recover the rights of brazikumab, which is a novel medicine that we had partnered out to Allergan, this product is coming back.
例如,當我們收回我們與 Allergan 合作開發的一種新藥 brazikumab 的權利時,該產品又回來了。
And we will have to -- we will receive basically complete funding for this development, but we have to book it somewhere and we will book it as other income.
我們將不得不——我們將獲得基本完整的開發資金,但我們必須在某個地方預訂,我們將把它記為其他收入。
So the line of other income is not only disposal.
所以其他收入的線不只是處置。
They will be including disposal, but also income on the deal, for instance, at the IL-23.
他們將包括處置,但也包括交易收入,例如 IL-23。
Just to provide some context on the sum of collaboration revenue and other income, you were asking whether it would be in line.
只是為了提供有關協作收入和其他收入總和的一些背景信息,您問的是它是否符合要求。
I think it's going to be in line, not materially different from what you saw in 2019.
我認為這將是一致的,與您在 2019 年看到的沒有實質性不同。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
And your first question.
還有你的第一個問題。
Essentially, we've guided on top line growth being high single digit to low double digit.
從本質上講,我們已經指導收入增長從高個位數到低兩位數。
We've said that our emerging market will be low double-digit growth, and China leads the pack typically.
我們已經說過,我們的新興市場將實現兩位數的低增長,而中國通常處於領先地位。
So it's going to be higher than this.
所以它會比這更高。
I'll just let -- leave it to you to do the math of how much China can represent of our total growth, but it will remain an important part of our sales growth.
我只是讓 - 留給你算算中國能代表我們的總增長多少,但它仍將是我們銷售增長的重要組成部分。
Mark Douglas Purcell - Equity Analyst
Mark Douglas Purcell - Equity Analyst
It's Mark Purcell from Morgan Stanley.
我是摩根士丹利的 Mark Purcell。
Just sticking on that same subject.
只是堅持同一個主題。
Could you provide color and context behind the investment initiatives in non-China emerging markets and acceleration of growth anticipated in these regions.
您能否提供非中國新興市場投資計劃背後的色彩和背景以及這些地區預期的增長加速?
You highlighted Latin America and MENA, Russia in the press release.
您在新聞稿中強調了拉丁美洲和中東和北非、俄羅斯。
And the reason why I asked the question is, in 2018, you increased marketing investment from mid-single digits to 10%.
我問這個問題的原因是,在 2018 年,你們將營銷投資從中個位數增加到 10%。
And then we saw what happened in terms of the acceleration in China.
然後我們看到了中國加速發展的情況。
So if you could help us understand how much incremental investment you're putting into these markets and how much inflection you're assuming.
所以,如果你能幫助我們了解你在這些市場上投入了多少增量投資,以及你假設了多少變化。
When I step back, 60% of your EM sales are in China, 40% non-China.
當我退一步說,你們 60% 的新興市場銷售額在中國,40% 在中國以外。
For most companies, it's 30-70, the other way around.
對於大多數公司來說,它是 30-70,反之亦然。
So maybe comment in terms of your expectations of the balance going forward, your comments around diversification of EM.
因此,也許可以根據您對未來平衡的期望以及您對 EM 多元化的評論發表評論。
And then we've talked about VBP and we've talked about NRDL.
然後我們討論了 VBP 和 NRDL。
Are other countries in these regions considering similar schemes, which could accelerate the uptake of your new medicines and potentially accelerate the decline of legacy medicines?
這些地區的其他國家是否正在考慮類似的計劃,這可能會加速新藥的採用並可能加速遺留藥物的衰落?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
How many questions into one?
多少個問題合為一個?
The investment, I mean, we will continue to invest in emerging markets.
投資,我的意思是,我們將繼續投資新興市場。
If you remember many years ago, a number of years ago, we guided for the emerging markets to grow at high single digit.
如果你還記得很多年前,很多年前,我們指導新興市場以高個位數增長。
In fact, we've delivered low double-digit growth rate, of course, driven by China, but not only China.
事實上,我們已經實現了低兩位數的增長率,當然,這是由中國推動的,但不僅僅是中國。
And in fact, interestingly, in the last year or maybe a little bit more than a year, we've seen an accelerated growth rate in non-China emerging markets.
事實上,有趣的是,在過去一年或一年多一點的時間裡,我們看到非中國新興市場的增長速度加快。
So we have to continue supporting this.
所以我們必須繼續支持這一點。
The Russian team did an outstanding job last year and they grew tremendously, but not only Russia, many other countries.
俄羅斯隊去年的表現非常出色,他們取得了巨大的進步,不僅是俄羅斯,還有許多其他國家。
So I don't know, in terms of investment, we'll continue supporting this growth, and it's all included in the guidance we gave you for 2020.
所以我不知道,在投資方面,我們會繼續支持這種增長,這都包含在我們給你的 2020 年指導中。
So I can't be more specific than this.
所以我不能比這更具體了。
And that's it, right?
就是這樣,對吧?
The other question, the other part of the question?
另一個問題,問題的另一部分?
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
Other schemes like value-based pricing.
其他方案如基於價值的定價。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Yes.
是的。
No, outside of China, we haven't seen anything specific.
不,在中國以外,我們還沒有看到任何具體的東西。
It's just like governments are basically continuing to try and save money out of all products, and we work hard to get access for innovation.
就像政府基本上繼續嘗試從所有產品中省錢一樣,我們努力工作以獲得創新的機會。
There are countries where actually, it's working faster than others.
實際上,在某些國家/地區,它的工作速度比其他國家/地區快。
And again, Russia is a good example of a place where we have got access for innovation.
再一次,俄羅斯是我們獲得創新機會的地方的一個很好的例子。
We're making good progress in -- it's not an emerging market, but it has tended to be a difficult market, Poland.
我們正在取得良好進展 - 它不是一個新興市場,但它往往是一個困難的市場,波蘭。
Poland is a large country, as you know, but it has been a country where access was difficult.
如您所知,波蘭是一個大國,但它一直是一個難以進入的國家。
We made very good progress in terms of getting access for innovative medicines.
我們在獲得創新藥物方面取得了很好的進展。
We're getting access in countries like Korea.
我們正在韓國等國家/地區獲得訪問權限。
Brazil is also doing quite well.
巴西也做得很好。
So -- but nothing really as specific or dramatic as what we have seen in China.
所以——但沒有什麼比我們在中國看到的更具體或更戲劇化了。
We'll have to take one last question, sorry about this.
我們必須回答最後一個問題,對此深感抱歉。
Yes, go ahead.
好,去吧。
Emmanuel Douglas Papadakis - MD & Head of European Pharmaceuticals Research
Emmanuel Douglas Papadakis - MD & Head of European Pharmaceuticals Research
Emmanuel Papadakis from Barclays.
來自巴克萊銀行的伊曼紐爾帕帕達基斯。
Two follow-ups.
兩次跟進。
One for you José quickly on -- and as has been said, there's been no further incidences of Grade 5 ILD and 5.4.
José 很快就給你一個——正如已經說過的,5 級 ILD 和 5.4 沒有進一步發生。
I think in December Daiichi was kind enough to say there'd been no further cases of Grade 4 or 5 and only 1 further case of Grade 3. So could you just confirm that is still the case?
我認為 Daiichi 在 12 月好心地說沒有更多的 4 級或 5 級病例,只有 1 例 3 級病例。那麼你能確認情況仍然如此嗎?
And then in terms of future clinical development plans, Daiichi also outlined potentially aggressive set of programs, including adjuvant, which you've yet to confirm their meeting in December.
然後就未來的臨床開發計劃而言,Daiichi 還概述了一系列潛在的激進計劃,包括佐劑,您尚未確認他們在 12 月舉行的會議。
So any further thoughts you can provide us there?
那麼您可以在那裡向我們提供任何進一步的想法嗎?
A quick follow on Tagrisso first-line NRDL.
快速了解 Tagrisso 一線 NRDL。
Are you expecting to take a price hit when and if that approval comes at the end of this year?
如果在今年年底獲得批准,您是否預計價格會受到衝擊?
And then Lynparza.
然後是林帕扎。
Could you just talk about the potential speed of uptake assuming a prostate approval in the second half of this year in terms of the biomarker hurdle to utilization at D&E across therapies for that setting?
你能否談談假設今年下半年前列腺獲批的潛在吸收速度,就生物標誌物在 D&E 跨療法利用的障礙而言?
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Yes.
是的。
So I mean let me go over Tagrisso China NRDL because there's not much we can add beyond what we've said in the past.
所以我的意思是讓我回顧一下 Tagrisso 中國 NRDL,因為除了我們過去所說的之外,我們沒有什麼可以補充的。
It's really -- getting access to first line, we've said a number of times, will be more challenging because, of course, the volume is so large, the budget impact is going to be substantial.
這真的——我們已經多次說過,進入一線將更具挑戰性,因為當然,數量如此之大,預算影響將是巨大的。
So we expect that there will be difficult discussions around pricing.
因此,我們預計圍繞定價將進行艱難的討論。
But beyond that, I can't say much more.
但除此之外,我不能說更多。
The -- I think the more critical question is relating to Enhertu actually, I will say.
我認為更關鍵的問題實際上與 Enhertu 有關,我會說。
And maybe Dave can say a couple of words on Lynparza uptake.
也許 Dave 可以就 Lynparza 的吸收說幾句話。
David Fredrickson - Executive Vice-President of Oncology Business Unit
David Fredrickson - Executive Vice-President of Oncology Business Unit
Yes.
是的。
The question on Enhertu was about early clinical trials or...
Enhertu 上的問題是關於早期臨床試驗或……
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
It was basically Daiichi announcing a number of new trials.
基本上是 Daiichi 宣布了一些新的試驗。
And also, can you confirm there hasn't been any new cases of ILD as such?
而且,您能否確認沒有任何新的 ILD 病例?
José Baselga - Executive Vice-President of Oncology Research & Development
José Baselga - Executive Vice-President of Oncology Research & Development
Yes.
是的。
I already commented on ILD in my -- in one of the answers to somebody from Deutsche Bank.
我已經在對德意志銀行某人的回答之一中對 ILD 發表了評論。
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
Menelas Pangalos - Executive Vice-President of BioPharmaceuticals Research & Development
I think the -- of Stage V there as well.
我認為那裡也有第五階段。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
No, you said Stage V and Stage IV.
不,你說的是第五階段和第四階段。
José Baselga - Executive Vice-President of Oncology Research & Development
José Baselga - Executive Vice-President of Oncology Research & Development
Stage V. Well, Stage -- yes, yes, I confirm that.
第五階段。嗯,階段——是的,是的,我確認。
I think Stage IV and -- yes, I confirm that.
我認為是第四階段——是的,我確認這一點。
The -- we -- as Daiichi has said, and we totally are as partners, we're going to be launching a number of clinical trials that is quite ambitious.
我們 - 正如 Daiichi 所說,我們完全是合作夥伴,我們將啟動一些非常雄心勃勃的臨床試驗。
So -- and it's very clear in the direction of going early into disease, right?
所以 - 早期進入疾病的方向非常明確,對吧?
So we are launching in the near future the trials in the early disease setting, neoadjuvant and adjuvant, and also first line.
因此,我們將在不久的將來啟動早期疾病環境、新輔助和輔助以及一線的試驗。
Now I cannot comment on other lines because our policy is not to comment on time lines, I'm sorry, until the clinical trials are announced.
現在我不能對其他線路發表評論,因為我們的政策是不對時間表發表評論,對不起,直到臨床試驗宣布。
So they are coming, and we'll give you more details as they become official.
所以他們來了,我們會在正式發佈時為您提供更多詳細信息。
Pascal Soriot - CEO & Executive Director
Pascal Soriot - CEO & Executive Director
Very good.
非常好。
So I'm really so sorry, we will have to finish here because we are already over time.
所以我真的很抱歉,我們必須在這裡結束,因為我們已經超時了。
Thank you so much for your interest.
非常感謝您的關注。
And look forward to another great year in 2020.
並期待 2020 年再創佳績。
Thank you.
謝謝你。
Bye.
再見。