Novartis AG (NVS) 2020 Q4 法說會逐字稿

Good morning, and good afternoon, and welcome to the Novartis Q4 and Full Year 2020 Results Release Conference Call and Live Audio Webcast.

早上好，下午好，歡迎來到諾華公司第四季度和 2020 年全年業績電話會議和現場音頻網絡直播。

(Operator Instructions) The conference is being recorded.

（操作員說明）正在錄製會議。

(Operator Instructions) A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends.

（操作員說明）電話會議的錄音，包括問答環節，將在電話會議結束後不久在我們的網站上提供。

(Operator Instructions)

（操作員說明）

With that, I would like to hand over to Mr. Samir Shah, Global Head of Investor Relations.

至此，我想向投資者關係全球主管 Samir Shah 先生匯報。

Please go ahead, sir.

請繼續，先生。

Thank you very much, and good morning and good afternoon to everybody, and thank you for taking the time to join us on this Q4 Full Year Results Presentation.

非常感謝大家，大家早上好，下午好，感謝您抽出時間參加我們的第四季度全年業績報告。

The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors.

今天提供的信息包含涉及已知和未知風險、不確定性和其他因素的前瞻性陳述。

These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.

這些可能導致實際結果與此類陳述所表達或暗示的任何未來結果、業績或成就存在重大差異。

Please refer to the company's Form 20-F on file with the U.S. Securities and Exchange Commission for a description of some of these factors.

請參閱公司在美國證券交易委員會存檔的 20-F 表格，了解其中一些因素的描述。

And thank you again for joining us, and I'll hand across to Vas Narasimhan.

再次感謝您加入我們，我將轉交給 Vas Narasimhan。

Vas.

瓦斯。

Thank you, Samir.

謝謝你，薩米爾。

And I also wanted to say thank you all for joining today's conference call.

我還想說謝謝大家參加今天的電話會議。

If we move to Slide 3. With me today, I have a number of my ECN colleagues.

如果我們轉到幻燈片 3。今天和我在一起，我有很多 ECN 同事。

Harry, Susanne, Marie-France, John Tsai, Richard and Shannon, and will be available to take your questions and also will be joining me for parts of the presentation.

Harry、Susanne、Marie-France、John Tsai、Richard 和 Shannon，將隨時回答您的問題，也將與我一起參加部分演示。

So if we move to Slide 5. Over the past 3 years, we've been executing on a strategy we set out in 2018 to focus the company, focus on certain geographies to accelerate our growth and to focus on 5 strategic priorities that we remain committed to and believe in the long run will enable Novartis to sustainably grow and sustainably have impact on health care around the world and deliver on our purpose to reimagine medicine.

因此，如果我們轉到幻燈片 5。在過去 3 年中，我們一直在執行我們在 2018 年制定的戰略，以專注於公司，專注於某些地區以加速我們的增長，並專注於我們仍然存在的 5 個戰略重點從長遠來看，致力於並相信這將使諾華能夠可持續發展並對全球醫療保健產生可持續影響，並實現我們重新構想醫學的目標。

Then when you look at some of the proof points.

然後，當您查看一些證明點時。

As we've set out on this journey, we believe we're making good progress.

隨著我們踏上這段旅程，我們相信我們正在取得良好的進展。

Always more to do, always things to learn, but we're making good progress.

總是要做更多的事情，總是要學習的東西，但我們正在取得良好的進展。

We're 100% focused now as a medicines company.

作為一家醫藥公司，我們現在 100% 專注。

We have a leading pipeline across 10 therapeutic areas, 4 advanced therapy platforms, unique in that having only 8% of our sales in 1 product and over 15 blockbusters.

我們擁有跨越 10 個治療領域、4 個先進治療平台的領先管道，其獨特之處在於 1 個產品和超過 15 個重磅炸彈僅占我們銷售額的 8%。

We've achieved $2 billion in cost savings over the last 3 years.

在過去的 3 年中，我們已經節省了 20 億美元的成本。

A leading data science platform that's enabling us to weather this pandemic and, I believe, sets us up for the medium and long term.

一個領先的數據科學平台，使我們能夠度過這一流行病，我相信，它為我們的中長期做好了準備。

Consistently improving ESG scores, now with sector-leading performance in 4 key indices.

持續提高 ESG 分數，目前在 4 個關鍵指數中表現領先。

And from a culture standpoint, record-high engagement scores across multiple different measures.

從文化的角度來看，多項不同衡量標準的參與度得分均創歷史新高。

Now moving to Slide 6. When you look at how the strategy has translated into operational performance, we see solid operational performance over the past 3 years, with sales growing 5% from $42 billion now to approaching $49 billion.

現在轉到幻燈片 6。當您查看該戰略如何轉化為運營績效時，我們看到過去 3 年的穩健運營績效，銷售額從現在的 420 億美元增長了 5%，接近 490 億美元。

Core op inc growing double-digit at 10%, exceeding now $15 billion.

Core op inc 以 10% 的兩位數增長，現已超過 150 億美元。

And we've reached our goal -- our initial goal of Innovative Medicines core margin to 35%, on our way to our midterm goal of the high 30s, which we are well on track to achieve.

我們已經實現了我們的目標——我們將創新藥物核心利潤率提高到 35% 的初始目標，正在朝著 30 年代中期目標邁進，我們有望實現這一目標。

Now turning to this year's performance -- sorry, the 2020 performance and Q4 performance.

現在轉向今年的表現——抱歉，2020 年的表現和第四季度的表現。

On Slide 7, you can see a breakdown of some of the key drivers.

在幻燈片 7 上，您可以看到一些關鍵驅動因素的細分。

As you saw in our release, net sales for the full year were up 3% and core operating income up 13%.

正如您在我們的新聞稿中看到的那樣，全年淨銷售額增長了 3%，核心營業收入增長了 13%。

Our overall performance in Q4 as well as the full year were driven by our key growth drivers, Entresto and Cosentyx, continuing to demonstrate double-digit growth, a broad range of oncology medicines also demonstrating double-digit growth.

我們在第四季度和全年的整體表現受到我們的主要增長驅動因素 Entresto 和 Cosentyx 的推動，繼續呈現兩位數的增長，廣泛的腫瘤藥物也呈現兩位數的增長。

And taken together, we now have over half of our sales coming from our key growth drivers and launches in Innovative Medicines, positioning us well for the future and positioning us well to overcome the patent expiries we have in this period and continue to drive growth through 2025 and beyond.

總而言之，我們現在有超過一半的銷售額來自我們的主要增長動力和創新藥物的推出，為我們的未來做好了準備，並為我們做好了克服這一時期專利到期的準備，並繼續通過以下方式推動增長2025 年及以後。

Now moving to Slide 8. I wanted to dive into a few of the products in Sandoz before turning it over to my colleagues.

現在轉到幻燈片 8。我想先深入了解 Sandoz 的一些產品，然後再將其交給我的同事。

First, on Zolgensma.

首先，關於 Zolgensma。

Full year sales were $920 million in the first full year since launch.

自推出以來的第一個全年銷售額為 9.2 億美元。

The medicine is now registered in 37 countries.

該藥現已在 37 個國家註冊。

We're making very good progress in the rollout of this medicine around the world.

我們在全球推廣這種藥物方面取得了非常好的進展。

As you saw in Q4, we had sales of $254 million, which were lower than Q3.

正如你在第四季度看到的，我們的銷售額為 2.54 億美元，低於第三季度。

This was driven primarily by COVID-19-related impact, delaying new starts as hospitals faced disruption and we saw physicians delaying starts or switches to the product, as well as delays in reimbursement decisions in some of the European and emerging markets we're currently working with.

這主要是由於與 COVID-19 相關的影響，由於醫院面臨中斷而推遲了新的開始，我們看到醫生推遲開始或切換到產品，以及我們目前所在的一些歐洲和新興市場的報銷決定延遲一起工作。

We expect this impact to continue through the first half of 2021, where we would expect sales in that Q3, Q4 range before an acceleration in the second half of the year.

我們預計這種影響將持續到 2021 年上半年，我們預計第三季度、第四季度的銷售額將在下半年加速。

But we remain confident in the longer-term potential of the medicine in the IV form to reach ultimately $2 billion.

但我們仍然對 IV 形式藥物的長期潛力充滿信心，最終達到 20 億美元。

It remains the treatment of choice for newly diagnosed patients.

它仍然是新診斷患者的首選治療方法。

We're seeing about 15% of patients in the EU in the older than 2 year age range.

我們在歐盟看到大約 15% 的患者年齡在 2 歲以上。

We're on our way to get access in 9 EU countries, which would be about 25% of the population.

我們正在進入 9 個歐盟國家，這將是大約 25% 的人口。

And we have important formal reimbursement decisions in 15 countries over the coming year to 2 years.

我們在未來一年到 2 年內在 15 個國家/地區做出了重要的正式報銷決定。

So taken together, we think we're on the right track.

綜上所述，我們認為我們走在正確的軌道上。

When you look at the IT program, we continue to await the animal data, which we expect to have in the middle of this year to the back half of this year, to remove the partial clinical hold if the data is -- confirms the safety profile.

當您查看 IT 程序時，我們繼續等待動物數據，我們預計將在今年年中到今年下半年獲得，以消除部分臨床保留，如果數據是 - 確認安全性輪廓。

We are working with the FDA to finalize the design of a pivotal confirmatory study, which we would then rapidly plan on implementing.

我們正在與 FDA 合作完成一項關鍵驗證性研究的設計，然後我們將迅速計劃實施。

We continue to progress our 10 early stage programs in gene therapies with 2 INDs and clinical trial starts planned in 2021.

我們繼續推進我們的 10 個基因治療早期項目，其中有 2 個 IND，併計劃於 2021 年開始臨床試驗。

Now moving to Slide 9. I also wanted to say a word regarding our performance in China.

現在轉到幻燈片 9。我還想談談我們在中國的表現。

Now as you saw in our release, we were verily pleased with our growth in China, with sales growing 16%, second-fastest amongst multinationals in China.

正如您在我們的新聞稿中看到的那樣，我們對我們在中國的增長感到非常滿意，銷售額增長了 16%，在中國的跨國公司中排名第二。

Our goal is to double our sales in the country by 2024, making China the second-largest market for Novartis in the world.

我們的目標是到 2024 年將我們在中國的銷售額翻一番，使中國成為諾華在全球的第二大市場。

Our key growth drivers, similar to what we see in other geographies, are Entresto, Cosentyx as well as our other oncology strategic brands.

與我們在其他地區看到的類似，我們的主要增長動力是 Entresto、Cosentyx 以及我們的其他腫瘤戰略品牌。

What's very notable, I think, is the number of NRDL listings we achieved, we believe the highest in the industry in 2020.

我認為，非常值得注意的是我們實現的 NRDL 列表數量，我們相信是 2020 年行業中最高的。

We also have a rich pipeline with 7 approvals expected in 2021.

我們還擁有豐富的管道，預計 2021 年將獲得 7 項批准。

So taken together, we think we're on the right track to reach our goals in China and really continue to drive dynamic growth in this important market.

綜上所述，我們認為我們正走在實現我們在中國的目標的正確軌道上，並真正繼續推動這個重要市場的動態增長。

Now moving to Slide 10.

現在轉到幻燈片 10。

With respect to Sandoz, you saw in the full year, Sandoz [met] the sales guidance, largely in line for the full year and the quarter.

至於山德士，您在全年看到，山德士 [達到] 銷售指導，與全年和季度基本一致。

Importantly, Sandoz was able to drive 15% core operating income growth, moving its core margin up to 24.2%.

重要的是，山德士能夠推動 15% 的核心營業收入增長，將其核心利潤率提高到 24.2%。

Some of the pushes and pulls for Sandoz are: Continued strong Biopharmaceuticals performance with 19% growth, primarily in the European market; but also held back a bit by our retail declines we saw driven by COVID-19 and the U.S. oral solids business that we now retain.

山德士的一些推動和拉動包括： 生物製藥業績持續強勁，增長 19%，主要在歐洲市場；但也因我們看到的由 COVID-19 和我們現在保留的美國口服固體業務推動的零售下滑而有所阻礙。

I think, taking longer-term view on Sandoz, we remain determined to build a business that can grow mid-single-digit with margins in the mid- to high 20s, really competitive with the top end of the peer set.

我認為，從長遠的角度來看山德士，我們仍然決心建立一個能夠在 20 多歲的中高利潤率實現中個位數增長的業務，與同行的高端產品真正具有競爭力。

And we expect to be able to do that through a robust biosimilars pipeline as well as high LOE coverage amongst small molecules through the 2024 period.

我們希望能夠通過強大的生物仿製藥管道以及到 2024 年期間小分子的高 LOE 覆蓋率來做到這一點。

Now moving to Slide 11.

現在轉到幻燈片 11。

I did want to say a word about the company's efforts to overcome the COVID-19 challenges we see in the marketplace.

我確實想談談公司為克服我們在市場上看到的 COVID-19 挑戰所做的努力。

Harry will talk a little bit more about our guidance.

哈利會多談談我們的指導。

But certainly, when you look at the health care system's performance over the back half of last year, we continue to see a situation where health care systems didn't return fully to their pre-pandemic levels.

但可以肯定的是，當您查看去年下半年醫療保健系統的表現時，我們繼續看到醫療保健系統沒有完全恢復到大流行前水平的情況。

Here on the left-hand side of the chart, you see 2 examples.

在圖表的左側，您可以看到 2 個示例。

In dermatology, we continue to see patient visits and NBRx below the pre-pandemic levels.

在皮膚科，我們繼續看到患者就診次數和 NBRx 低於大流行前的水平。

In the bottom, you can see, in the oncology markets, depending on the cancer setting, you have biopsy and surgery rates below pre-pandemic levels, also in the CDK4/6 market.

在底部，您可以看到，在腫瘤學市場中，根據癌症環境，您的活檢和手術率低於大流行前水平，CDK4/6 市場也是如此。

So for the first half of the 2021, we expect to continue to see challenges for certain therapeutic areas, such as dermatology and ophthalmology as well as in Sandoz retail.

因此，在 2021 年上半年，我們預計某些治療領域將繼續面臨挑戰，例如皮膚科和眼科以及山德士零售。

We expect that some of our new launches will be impacted, though we expect to continue to see solid progress, and you'll hear more about that from Marie-France, on preparing for these launches to accelerate in the back half of the year, such as Kesimpta and Mayzent.

我們預計我們的一些新發布將受到影響，儘管我們預計將繼續看到堅實的進展，您會從 Marie-France 那裡聽到更多關於為這些發佈在今年下半年加速做準備的信息，例如 Kesimpta 和 Mayzent。

And we also know products that involve hospital initiation, such as Kymriah, Lutathera and Zolgensma, will face a tougher situation in the first part of the year.

我們還知道，Kymriah、Lutathera 和 Zolgensma 等涉及醫院啟動的產品將在今年上半年面臨更嚴峻的形勢。

Again, we would plan to overcome that in this period and then hopefully see acceleration in the second half of the year.

同樣，我們將計劃在此期間克服這一問題，然後希望在下半年看到加速。

Now moving to Slide 12.

現在轉到幻燈片 12。

Turning to our innovation performance and innovation milestones in Q4, we saw the approval of Leqvio in the EU 6 months ahead of schedule.

談到我們在第四季度的創新表現和創新里程碑，我們提前 6 個月看到了 Leqvio 在歐盟的批准。

We saw the positive FDA AdComm for Entresto in preserved ejection fraction heart failure, as well as a number of other notable achievements, a number of designations achieved for iptacopan and ligelizumab, I think, demonstrating the potential of these medicines as they continue to progress in late-stage development.

我們看到了 FDA AdComm 對 Entresto 在保留射血分數心力衰竭方面的積極影響，以及許多其他顯著成就，我認為 iptacopan 和 ligelizumab 獲得了一些指定，證明了這些藥物在繼續取得進展時的潛力後期發展。

We also signed an important in-licensing deal on tislelizumab with BeiGene for anti-PD-1, which we hope we'll be able to file later this year in the U.S. and other markets.

我們還與百濟神州簽署了一項重要的 tislelizumab 抗 PD-1 許可協議，我們希望今年晚些時候能夠在美國和其他市場提交該協議。

I also wanted to say a word, as I know there have been a number of questions, on Leqvio, and an update on the CRL.

我還想說一句話，因為我知道有很多關於 Leqvio 的問題，以及關於 CRL 的更新。

Now first and foremost, it's important to note that there are no safety, efficacy or product-related concerns with respect to Leqvio in the CRL.

現在首先，重要的是要注意 CRL 中沒有關於 Leqvio 的安全性、有效性或產品相關問題。

The -- as I mentioned, the EU fully approved this product out of the same facilities that we also filed for the U.S. FDA.

- 正如我所提到的，歐盟在我們也向美國 FDA 申請的相同設施中完全批准了該產品。

The CRL was related to facility inspection-related conditions primarily related to documentation that controls -- certain control systems at a third-party manufacturer in Europe.

CRL 與設施檢查相關的條件有關，主要與控製文件有關——歐洲第三方製造商的某些控制系統。

We expect, based on the third party's readiness to complete the request made by FDA, to be able to submit the documentation and other requests of FDA in the Q2, Q3 time period.

我們預計，基於第三方完成 FDA 請求的準備情況，能夠在 Q2、Q3 時間段內提交 FDA 的文件和其他請求。

We still do not know if the FDA will ultimately want to inspect this facility.

我們仍然不知道 FDA 是否最終會檢查該設施。

As noted previously, the FDA had originally planned to inspect this facility in May of 2020.

如前所述，FDA 最初計劃在 2020 年 5 月對該設施進行檢查。

They are currently not conducting overseas inspections in situations like this.

他們目前沒有在這種情況下進行海外檢查。

So we'll continue to have to work with the FDA to try to expedite that inspection.

因此，我們將繼續與 FDA 合作，以加快檢查速度。

And we're concurrently working on a tech transfer to add -- our own Novartis facility in Schaftenau for the production supply chain of Leqvio.

我們正在同時進行技術轉讓，以增加我們在沙夫特瑙的諾華工廠，用於 Leqvio 的生產供應鏈。

So we remain confident we will get this product approved as fast as possible and then continue our plans to launch this medicine, which -- in a highly effective way, which Marie-France will go through in a bit more detail in a moment.

因此，我們仍然有信心，我們將盡快獲得該產品的批准，然後繼續我們推出該藥物的計劃，以一種高效的方式，Marie-France 稍後將詳細介紹。

Now moving to Slide 13, other innovation milestones that we expect for 2021.

現在轉到幻燈片 13，這是我們預計 2021 年的其他創新里程碑。

Multiple major approvals, Kesimpta in the EU, Entresto, have passed for an expanded indication for Entresto.

多項主要批准，即歐盟的 Kesimpta 和 Entresto，已通過擴大適用於 Entresto 的適應症。

A number of major submissions, you can see it listed here, including asciminib in CML.

一些主要的提交，你可以在這裡看到它，包括 CML 中的 asciminib。

We have also a range of major readouts which would enable submissions in 2021, notably canakinumab, sabatolimab, MBG453, and Lu-PSMA, amongst others.

我們還有一系列主要讀數，可以在 2021 年提交，尤其是 canakinumab、sabatolimab、MBG453 和 Lu-PSMA 等。

We also will hope to see the readouts of ligelizumab and Cosentyx, which would enable submissions in 2022.

我們還希望看到 ligelizumab 和 Cosentyx 的讀數，這將能夠在 2022 年提交。

And I also wanted to say a word on our next wave of assets which you can see on Slide 14.

我還想談談我們的下一波資產，你可以在幻燈片 14 上看到。

Here, we lay out the 5 life cycle management programs, 5 pharmaceutical programs, 5 oncology programs and 5 wildcards we highlighted in our Meet the Management meetings.

在這裡，我們列出了 5 個生命週期管理計劃、5 個製藥計劃、5 個腫瘤學計劃和 5 個通配符，我們在“與管理層會面”會議上強調了這一點。

And in many of these programs, we have milestones expected in 2021.

在其中許多計劃中，我們預計在 2021 年實現里程碑。

You can also see the milestone chart in the appendix of this document.

您還可以在本文檔的附錄中查看里程碑圖表。

I'll note a few.

我會注意一些。

We expect the PARADISE post-AMI trial to read out in the first half of 2021.

我們預計 PARADISE AMI 後試驗將在 2021 年上半年宣讀。

I already mentioned Cosentyx in hidradenitis suppurativa.

我已經在化膿性汗腺炎中提到了 Cosentyx。

The Kisqali MONALEESA-2 OS in the second half of '21.

21 年下半年的 Kisqali MONALEESA-2 操作系統。

We'll see important mid-stage readouts for iptacopan in IgA nephropathy and C3G.

我們將看到 iptacopan 在 IgA 腎病和 C3G 中的重要中期讀數。

We'll see also an important Phase IIb start for branaplam in Huntington's disease.

我們還將看到在亨廷頓氏病中 branaplam 的重要 IIb 期開始。

And then, of course, the range of oncology milestones as well across the oncology -- various oncology molecules.

然後，當然，腫瘤學里程碑的範圍以及整個腫瘤學——各種腫瘤學分子。

Important to note, in all of these projects, we have full teams working to accelerate them and working as fast as possible to maintain their progress through the pandemic and beyond.

重要的是要注意，在所有這些項目中，我們都有完整的團隊來加速它們，並儘可能快地工作，以保持它們在大流行期間及以後的進展。

Particularly, we're looking forward to continue to advance our SHP2 inhibitor and our CRAF inhibitor as well in the oncology portfolio.

特別是，我們期待繼續推進我們的 SHP2 抑製劑和 CRAF 抑製劑以及腫瘤學產品組合。

So I hope that gives you an overview of our story -- well, mid- and long-term story, most importantly, but also our story in Q4 and for 2021.

因此，我希望這能讓您大致了解我們的故事——嗯，中期和長期的故事，最重要的是，還有我們在第四季度和 2021 年的故事。

And with that, I'll hand it over to Marie-France.

有了這個，我會把它交給 Marie-France。

Thank you, Vas.

謝謝你，瓦斯。

So going on to Slide 16.

所以繼續幻燈片 16。

Good morning, good afternoon.

早上好，下午好。

I'm pleased to update you on the 2020 performance for Pharma.

我很高興向您介紹 Pharma 2020 年的業績。

We grew 5% year-over-year in a challenging environment.

在充滿挑戰的環境中，我們同比增長 5%。

And our growth drivers, Cosentyx and Entresto, showed continued momentum and now account for $6.5 billion in revenues.

我們的增長動力 Cosentyx 和 Entresto 顯示出持續的增長勢頭，目前收入為 65 億美元。

But the story that stands out here is the shift that you see in our portfolio.

但這裡突出的故事是您在我們的投資組合中看到的轉變。

The contribution from growth drivers and launches went from 33% to 43%, and that demonstrates our replacement power in light of several patent expiries expected.

增長動力和發布的貢獻從 33% 上升到 43%，這表明了我們在幾個預期專利到期的情況下的替代能力。

We're delivering strong operational performance in the end-market growth drivers.

我們在終端市場增長驅動力方面提供了強勁的運營業績。

We also made progress in the next wave of potential launches, providing the basis for growth in 2021 and beyond.

我們還在下一波潛在發布中取得了進展，為 2021 年及以後的增長奠定了基礎。

Slide 17.

幻燈片 17。

Once again, Cosentyx delivered double-digit growth and reached $4 billion for the full year.

Cosentyx 再次實現兩位數的增長，全年達到 40 億美元。

Our focus is on continuing to compete strongly to maintain our position in dermatology and accelerate in rheumatology.

我們的重點是繼續激烈競爭，以保持我們在皮膚病學領域的地位並加速在風濕病學領域的發展。

We know what we need to do to grow.

我們知道我們需要做什麼才能成長。

We need to make sure we maintain broad access and balance that with the long-term value of Cosentyx, and you can expect us to continue to do that.

我們需要確保我們保持廣泛的訪問權限並與 Cosentyx 的長期價值保持平衡，您可以期望我們繼續這樣做。

We'll expand into new geographies.

我們將擴展到新的地區。

In fact, we're now the only innovative biologic with broad NRDL listing in China.

事實上，我們現在是中國唯一一家擁有廣泛的國家醫保目錄的創新生物。

And we'll make sure that we're competitive in the marketplace with our industry-leading approach to data and presence as well as a number of new indications as we deliver on our ambitious life cycle management program.

我們將通過我們行業領先的數據和存在方法以及許多新的跡象來確保我們在市場上具有競爭力，因為我們正在實施我們雄心勃勃的生命週期管理計劃。

There is still tremendous opportunity in this market.

這個市場仍然存在巨大的機會。

And between the data, the access and our outstanding teams, we have what it takes for Cosentyx to continue to grow.

在數據、訪問權限和我們優秀的團隊之間，我們擁有 Cosentyx 繼續發展所需的一切。

On Slide 18, Entresto continues to deliver 44% full year growth, and the momentum continues across all of the geographies.

在幻燈片 18 上，Entresto 繼續實現 44% 的全年增長，並且這一勢頭在所有地區都在持續。

As you know, we're the only single-use medicine proven to be superior to previous standard of care.

如您所知，我們是唯一被證明優於以前的護理標準的一次性藥物。

And thus, we're in a strong competitive position.

因此，我們處於強大的競爭地位。

It's also great to see that the American College of Cardiologists expert consensus now recommends that heart failure patients go direct to ARNI, and this puts Entresto in a pole position for the 75% of patients who are still on standard -- sorry, previous standard of care.

也很高興看到美國心髒病學會專家共識現在建議心力衰竭患者直接去 ARNI，這使 Entresto 對 75% 仍處於標準的患者處於領先地位——抱歉，以前的標準關心。

We also have exciting opportunities for growth with expansion in China and Japan as well as our life cycle management program for PEF or preserved ejection fraction in post-AMI.

隨著在中國和日本的擴張以及我們的 PEF 或 AMI 後保留射血分數的生命週期管理計劃，我們也有令人興奮的增長機會。

If we move to the next slide.

如果我們轉到下一張幻燈片。

The AdComm discussion for PEF reinforced the unmet need as well as Entresto's value in the treatment of preserved ejection fraction, and specifically in patients with ejection fraction below normal.

關於 PEF 的 AdComm 討論強化了未滿足的需求以及 Entresto 在治療保留射血分數，特別是射血分數低於正常值的患者中的價值。

Ultimately, the addressable patient pool will depend on the label.

最終，可尋址的患者池將取決於標籤。

What I can tell you is that the total PEF population is about 3 million in the U.S. and about 2 million of them have an ejection fraction below normal.

我可以告訴你的是，美國的 PEF 總人口約為 300 萬，其中約 200 萬的射血分數低於正常值。

We know from our deep experience in rEFs that guidelines matter in this market, so our update will be gradual as the guidelines evolve.

根據我們在 rEF 方面的豐富經驗，我們知道指南在這個市場中很重要，因此隨著指南的發展，我們的更新將是漸進的。

Overall, we're very comfortable with Entresto's peak consensus, and we're confident that Entresto is going to continue on its impressive growth trajectory.

總體而言，我們對 Entresto 的最高共識感到非常滿意，我們相信 Entresto 將繼續其令人印象深刻的增長軌跡。

If we move to Slide 20 and on to Kesimpta.

如果我們移動到幻燈片 20，然後轉到 Kesimpta。

We've said we have high expectations for this product.

我們已經說過我們對這款產品寄予厚望。

Our team is executing very effectively on the launch.

我們的團隊在發佈時執行得非常有效。

In fact, we have beat all of our plans on gaining access.

事實上，我們已經完成了所有獲得訪問權限的計劃。

We're seeing broad adoption.

我們看到了廣泛的採用。

We have leading share of attention.

我們擁有領先的關注度。

Onboarding is fast and initiation is simple.

入職速度很快，啟動也很簡單。

But we do feel that it is more challenging to launch during a pandemic.

但我們確實認為在大流行期間啟動更具挑戰性。

We cannot move as fast as we would like due to the limited face-to-face access to physicians.

由於與醫生的面對面接觸有限，我們無法像我們希望的那樣快速行動。

And what we're also seeing is a hesitancy to switch as physicians and patients prefer to wait.

而且我們還看到，由於醫生和患者更願意等待，因此對轉換的猶豫不決。

But this does not change our ambition for this product.

但這並沒有改變我們對這款產品的抱負。

We think that B-cell therapies have the potential to account to up to 40% of market share in MS. And we're positioning Kesimpta as a first-choice DMT as we relentlessly track for the highest customer satisfaction.

我們認為 B 細胞療法有可能佔據 MS 市場高達 40% 的份額。我們將 Kesimpta 定位為首選 DMT，因為我們不懈地追踪最高的客戶滿意度。

We have the foundational elements in place.

我們已經具備了基本要素。

We're focusing on breadth.

我們專注於廣度。

And with our free drug program, once we're out of this pandemic and we can pull our full promotional power behind Kesimpta, we will really see the potential of this product.

通過我們的免費藥物計劃，一旦我們擺脫了這場大流行，我們可以將我們的全部宣傳力量推向 Kesimpta，我們將真正看到這個產品的潛力。

If we move on to Slide 21.

如果我們繼續看幻燈片 21。

We're also enthusiastically preparing for the launch of Leqvio.

我們也在熱心地為 Leqvio 的推出做準備。

Leqvio received EU approval in December, and we expect a slow and steady start.

Leqvio 在 12 月獲得了歐盟的批准，我們預計會有一個緩慢而穩定的開端。

We also plan to roll out our first population health agreement with the U.K. NHS in quarter 3. In the U.S., as you've heard, we have a manufacturing-related delay which we're working to resolve, but what is important to remember is that we're thinking about this launch very differently.

我們還計劃在第三季度與英國 NHS 推出我們的第一份人口健康協議。在美國，正如你所聽到的，我們正在努力解決與製造相關的延誤，但重要的是要記住是我們對這次發射的看法非常不同。

Our aim is to partner with health care systems on ASCVD management to overcome the nonclinical barriers to tackling this disease at scale.

我們的目標是與衛生保健系統合作進行 ASCVD 管理，以克服大規模應對這種疾病的非臨床障礙。

We're now using this time to advance our engagement with health care systems and to set up the needed infrastructure so that we can be stronger out of the gate once we get the green light from FDA.

我們現在正在利用這段時間來推進我們與醫療保健系統的合作，並建立所需的基礎設施，這樣一旦我們獲得 FDA 的批准，我們就能變得更加強大。

Slide 22.

幻燈片 22。

2020 was definitely a year like no other.

2020 年絕對是與眾不同的一年。

But the external environment did not stop us from doing what we're passionate about, and that is bringing medicines to patients.

但外部環境並沒有阻止我們做我們熱愛的事情，那就是把藥物帶給病人。

Our teams have worked hard and demonstrated great agility and resilience, and I am very proud of this team.

我們的團隊努力工作並表現出極大的敏捷性和韌性，我為這個團隊感到非常自豪。

Our 2021 strategy builds on the good work done.

我們的 2021 年戰略建立在出色工作的基礎上。

Number one, we want to maintain the momentum on Cosentyx and Entresto, penetrating markets further and delivering on our life cycle management programs; two, executing our launches, ramping up Kesimpta, bringing Leqvio to market and restoring confidence in Beovu; and three, getting ready for the next wave of launches.

第一，我們希望保持 Cosentyx 和 Entresto 的發展勢頭，進一步滲透市場並實施我們的生命週期管理計劃；第二，執行我們的發布，加速 Kesimpta，將 Leqvio 推向市場並恢復對 Beovu 的信心；第三，為下一波發布做準備。

Geographically, we have a clear focus on the U.S. and China, and we're putting our customers at the core of our strategy.

在地理上，我們明確關注美國和中國，我們將客戶置於我們戰略的核心。

You will see us working in a much more personalized fashion with physicians, leveraging the investments that we've made in data and digital, and with health care systems to deliver access to more patients faster.

您將看到我們以更加個性化的方式與醫生合作，利用我們在數據和數字方面的投資，以及與醫療保健系統一起更快地為更多患者提供治療。

Over to Susanne.

交給蘇珊。

Thank you, Marie-France.

謝謝你，瑪麗-法蘭西。

So moving to Slide 24.

所以轉到幻燈片 24。

The Oncology business had solid performance despite significant generic erosion and COVID impact, delivering 3% growth and reaching $14.7 billion.

儘管有顯著的仿製藥侵蝕和 COVID 影響，腫瘤業務仍表現穩健，實現了 3% 的增長並達到 147 億美元。

In Q4, we have seen very good momentum across our portfolio, mainly driven by the strong uptake of our recent launches and continued strong performance of our growth drivers.

在第四季度，我們的投資組合勢頭非常好，這主要是由於我們最近推出的產品的強勁增長以及我們增長動力的持續強勁表現。

And these brands could also more than compensate for the continued generic erosion of Afinitor and Exjade, Jadenu in the U.S. and Sandostatin LAR in the EU.

這些品牌還可以彌補 Afinitor 和 Exjade、美國的 Jadenu 和歐盟的 Sandostatin LAR 的持續仿製藥侵蝕。

Due to the pandemic, some areas of our business, as mentioned by Vas, like the hospital-initiated therapies and specifically breast cancer therapies, continue to experience delays in new patient starts as well as concerns about patient management during COVID.

由於大流行，正如 Vas 所提到的，我們業務的某些領域，例如醫院啟動的療法，特別是乳腺癌療法，繼續遇到新患者開始延遲以及在 COVID 期間對患者管理的擔憂。

And -- but I have to say our teams really stepped [out], and we leveraged our robust digital capabilities, embarked -- and embarked on omnichannel launches for Tabrecta in the U.S. and Piqray and Adakveo in Europe.

而且——但我不得不說，我們的團隊真的[退出]了，我們利用我們強大的數字能力，開始——並著手在美國為 Tabrecta 和歐洲的 Piqray 和 Adakveo 推出全渠道產品。

And are very pleased that this launch has continued gaining momentum despite limited face-to-face interactions with physicians.

並且很高興儘管與醫生的面對面互動有限，但此次發布仍繼續獲得動力。

Moving to Slide 25 and Kisqali.

轉到幻燈片 25 和 Kisqali。

Kisqali delivered a very strong performance in 2020 with full year sales up 45%, reaching $870 million.

Kisqali 在 2020 年的表現非常強勁，全年銷售額增長 45%，達到 8.7 億美元。

And this is driven by the unprecedented overall survival benefit from 2 pivotal Phase III clinical trials.

這是由 2 項關鍵 III 期臨床試驗帶來的前所未有的總體生存獲益所推動的。

We are also very pleased to see Kisqali continue growing and gaining market share despite the overall slowdown of the CDK4/6 market, driven by suppressed patient screening and overall decrease in new patient starts.

我們也很高興看到 Kisqali 繼續增長並獲得市場份額，儘管 CDK4/6 市場整體放緩，這是由於患者篩查受到抑制和新患者開始總體減少。

At a recent Congress in San Antonio, we were very proud to share that Kisqali demonstrated the longest median overall survival among all Phase III trials in advanced breast cancer, reaching nearly 5 years of survival in premenopausal patients.

在最近在聖安東尼奧舉行的一次大會上，我們非常自豪地分享 Kisqali 在晚期乳腺癌的所有 III 期試驗中表現出最長的中位總生存期，在絕經前患者中達到了近 5 年的生存期。

And additionally, we presented the pooled data from MONALEESA studies that confirmed efficacy across luminal and estrogen therapy-resistant HER2-enriched patient subtypes.

此外，我們提供了來自 MONALEESA 研究的匯總數據，這些數據證實了對 luminal 和雌激素治療耐藥的 HER2 富集患者亞型的療效。

And these data confirm that Kisqali's ability to selectively inhibit CDK4 may [restore] endocrine sensitivity in these very aggressive tumors.

這些數據證實，Kisqali 選擇性抑制 CDK4 的能力可能會在這些極具侵襲性的腫瘤中 [恢復] 內分泌敏感性。

On the development side, the NATALEE adjuvant study in intermediate- and high-risk populations is enrolling incredibly well, and we are on track for final readout in 2022.

在開發方面，針對中高風險人群的 NATALEE 輔助研究的招募情況非常好，我們有望在 2022 年進行最終讀數。

So overall, we are very pleased with the performance of Kisqali and remain very confident in this brand.

所以總的來說，我們對 Kisqali 的表現感到非常滿意，並對這個品牌充滿信心。

Moving to Slide 26.

轉到幻燈片 26。

Also, Kymriah had an excellent year with sales up 68%, driven by strong double-digit growth across all geographies despite pandemic conditions.

此外，Kymriah 的銷售額增長了 68%，這得益於在所有地區的強勁兩位數增長，儘管存在大流行情況。

We continue to expand our global presence with now over 290 centers qualified to administer Kymriah across 27 markets.

我們繼續擴大我們的全球影響力，現在有超過 290 個中心有資格在 27 個市場管理 Kymriah。

Commercial manufacturing for Kymriah has been expanded with the recent approval of FBRI in Japan, and this is building on previous approvals of Stein and Les Ulis earlier in the year.

隨著 FBRI 最近在日本獲得批准，Kymriah 的商業生產得到了擴展，這是建立在今年早些時候 Stein 和 Les Ulis 先前批准的基礎上的。

In 2020, we made also significant progress in expanding our global manufacturing capacity with a 70% increase compared to previous year.

2020年，我們在擴大全球製造能力方面也取得了重大進展，與上一年相比增長了70%。

And we also continue to improve the robustness of our process, leading to an increased manufacturing success rate.

我們還繼續提高工藝的穩健性，從而提高製造成功率。

On the development side, we were pleased to share the new data from the ELARA trial, showing that Kymriah is effective in pretreated patients with relapsed or refractory follicular lymphoma.

在開發方面，我們很高興分享 ELARA 試驗的新數據，表明 Kymriah 對經治的複發性或難治性濾泡性淋巴瘤患者有效。

Submission for this important indication is expected later this year.

預計今年晚些時候將提交這一重要指示。

And we have also presented the JULIET updated efficacy results, which showed continued durable responses for patients with relapsed or refractory DLBCL.

我們還展示了 JULIET 更新的療效結果，顯示復發或難治性 DLBCL 患者的持續持久反應。

We also continue to invest in our CAR-T therapies with already 2 new CAR-T assets in Phase I trials being manufactured on a completely novel CAR-T platform.

我們還繼續投資於我們的 CAR-T 療法，在 I 期試驗中已經有 2 個新的 CAR-T 資產在一個全新的 CAR-T 平台上製造。

With this technology, we expect to increase manufacturing reliability, shorten the turnaround times and the preservation of certain T cell subpopulations.

借助這項技術，我們期望提高製造可靠性、縮短周轉時間並保護某些 T 細胞亞群。

Moving to next slide.

轉到下一張幻燈片。

We'd like to share with you the exciting data we have recently presented at ASH on asciminib, our first-in-class STAMP inhibitor that has the potential to transform CML treatment standards.

我們想與您分享我們最近在 ASH 上展示的關於 asciminib 的激動人心的數據，我們的一流 STAMP 抑製劑有可能改變 CML 治療標準。

In the Phase III ASCEMBL trial, asciminib nearly doubled the major molecular response rate at 24 weeks compared to bosutinib in patients resistant to or intolerant of at least 2 prior TKIs.

在 III 期 ASCEMBL 試驗中，在對至少 2 種先前 TKI 耐藥或不耐受的患者中，與 bosutinib 相比，asciminib 在 24 週時的主要分子反應率幾乎翻了一番。

Asciminib also demonstrated favorable safety profile, underscoring that STAMP inhibition reduces the off-target adverse events typical for TKIs.

Asciminib 還表現出良好的安全性，強調 STAMP 抑制減少了 TKI 典型的脫靶不良事件。

The U.S. FDA has granted fast track designation earlier in December, and we are on track with the U.S. and EU submissions in the first half of '21.

美國 FDA 已於 12 月初授予快速通道指定，我們正在按計劃在 21 年上半年提交美國和歐盟的申請。

We also continue evaluating multiple development options for asciminib in early treatment lines in CML, and looking forward to update you in the future.

我們還將繼續評估 asciminib 在 CML 早期治療線上的多種開發選擇，並期待在未來為您提供更新。

Moving to Slide 28.

轉到幻燈片 28。

I would like to give an outlook also on '21.

我也想對 21 年做一個展望。

We will continue to maximize our growth drivers, and we expect continued growth from Kisqali.

我們將繼續最大化我們的增長動力，我們預計 Kisqali 將繼續增長。

We are going to leverage the increased manufacturing capacity to drive further growth in Kymriah.

我們將利用增加的製造能力來推動 Kymriah 的進一步增長。

And for Lutathera, we plan to unlock the potential in the community setting in the U.S. and grow use in earlier lines.

對於 Lutathera，我們計劃在美國的社區環境中釋放潛力，並在早期生產線中增加使用。

We expect also continued growth from our growth drivers, Revolade, Promacta, Jakavi and Tafinlar + Mekinist.

我們預計，我們的增長動力 Revolade、Promacta、Jakavi 和 Tafinlar + Mekinist 也將繼續增長。

We are also committed to deliver on our launches.

我們還致力於交付我們的產品。

We will further expand Piqray in the U.S. and gain momentum in Europe.

我們將在美國進一步擴展 Piqray，並在歐洲獲得發展勢頭。

And we hope to continue strong on Adakveo, expanding to larger accounts in the U.S. and continued global rollout.

我們希望繼續在 Adakveo 上保持強勢，擴展到美國的更大客戶並繼續在全球推廣。

We will further maximize the first-mover advantage with Tabrecta in the U.S. and we'll continue driving awareness of CML and the unmet need and the importance of STAMP inhibitors.

我們將進一步最大限度地利用 Tabrecta 在美國的先發優勢，我們將繼續提高對 CML 和未滿足的需求以及 STAMP 抑製劑重要性的認識。

Last but not least, we will prepare for our next big bets, lutetium-PSMA, by advancing our commercial organization for the readout of VISION trial later this year, and also focus in medical education on canakinumab to establish the importance of pro-tumor inflammation.

最後但並非最不重要的一點是，我們將通過推動我們的商業組織在今年晚些時候宣讀 VISION 試驗，為我們的下一個大賭注 lutetium-PSMA 做準備，並專注於卡那奴單抗的醫學教育，以確定促腫瘤炎症的重要性.

Another important focus for us is the medical education on sabatolimab to build awareness for the dual mechanism of action of TIM-3 in MDS and AML.

我們的另一個重點是關於 sabatolimab 的醫學教育，以建立對 TIM-3 在 MDS 和 AML 中的雙重作用機制的認識。

And as Vas said, we are advancing our early assets, TNO155 and LXH254 in a broad range of combination studies.

正如 Vas 所說，我們正在廣泛的組合研究中推進我們的早期資產 TNO155 和 LXH254。

Moving to Slide 29, just to give you an update on the recently announced deal to in-license tislelizumab from BeiGene.

轉到幻燈片 29，只是為了讓您了解最近宣布的百濟神州許可 tislelizumab 交易的最新情況。

This is a late-stage PD-1 inhibitor specifically engineered to minimize binding to the Fc-gamma receptor on macrophages.

這是一種晚期 PD-1 抑製劑，專門設計用於最大限度地減少與巨噬細胞上 Fc-γ 受體的結合。

Tislelizumab has 15 potentially registration-enabling clinical trials currently ongoing with first ex China filing expected in 2021.

替雷利珠單抗目前正在進行 15 項可能註冊的臨床試驗，預計將於 2021 年首次在中國提交申請。

With this deal, Novartis obtains development and commercial rights on key markets, ex China, including U.S., Europe and Japan.

通過這筆交易，諾華獲得了除中國以外的主要市場的開發和商業權利，包括美國、歐洲和日本。

It is a very attractive asset for us as we look to expand our presence in the checkpoint inhibitor space, and it provides us with an opportunity to launch a PD-1 sooner in broad and important indications such as lung cancer.

這對我們來說是一項非常有吸引力的資產，因為我們希望擴大我們在檢查點抑製劑領域的存在，它為我們提供了在肺癌等廣泛而重要的適應症中更快推出 PD-1 的機會。

We have identified also multiple potential combination opportunities with the Novartis portfolio across all of our 4 therapeutic platforms.

我們還在我們所有的 4 個治療平台中發現了與諾華產品組合的多個潛在組合機會。

So we are very excited about collaborating with BeiGene to bring tislelizumab to patients around the world.

因此，我們很高興與百濟神州合作，將替雷利珠單抗帶給世界各地的患者。

And we are looking forward to provide you with more updates after the transaction is closed later this year.

我們期待在今年晚些時候交易完成後為您提供更多更新。

And with that, I hand over to Harry.

有了這個，我交給哈利。

Thank you, Susanne.

謝謝你，蘇珊。

Good morning, good afternoon, everyone.

大家早上好，下午好。

I'm now going to walk you through some of the financials for the fourth quarter and full year as well as provide you with our '21 guidance.

我現在將向您介紹第四季度和全年的一些財務狀況，並為您提供我們的 21 年指導。

As always, my comments refer to results of continuing operations and growth rates in constant currencies, unless otherwise noted.

與往常一樣，除非另有說明，否則我的評論指的是持續經營的結果和以固定貨幣計算的增長率。

So turning to Slide 31.

所以轉向幻燈片 31。

We compare our actual results here with our 2020 latest guidance.

我們將此處的實際結果與我們 2020 年的最新指南進行比較。

And as you know, we've revised our core operating income guidance upward in October.

如您所知，我們已在 10 月上調了核心營業收入指引。

And I'm pleased to say that we met both core operating income and the sales guidance.

我很高興地說，我們達到了核心營業收入和銷售指導。

On sales, given the resurgence of COVID-19 in quarter 4, we ended at the low end of the 3% to 4% range, as we mentioned during the quarter 3 investor call.

在銷售方面，鑑於第 4 季度 COVID-19 的複蘇，正如我們在第 3 季度投資者電話會議中提到的那樣，我們以 3% 至 4% 範圍的低端結束。

Now Slide 32 shows you the summary of the performance for quarter 4 and full year.

現在，幻燈片 32 向您展示了第 4 季度和全年的業績摘要。

I will focus on the full year results on the right-hand side.

我將重點關注右側的全年結果。

Full year performance was solid, with sales growing 3% and both core operating income and core EPS growing 13%.

全年業績穩健，銷售額增長 3%，核心營業收入和核心每股收益均增長 13%。

Sales were, of course, mainly driven by Entresto, Zolgensma and Cosentyx.

當然，銷售主要由 Entresto、Zolgensma 和 Cosentyx 推動。

Core operating income growth was driven by higher sales, some lower spend and significant productivity programs.

核心營業收入增長是由較高的銷售額、較低的支出和重要的生產力計劃推動的。

Operating income grew 19%, driving net income growth of 20%.

營業收入增長19%，帶動淨收入增長20%。

We will come back to the free cash flow number, which was $11.7 billion, a little later.

稍後我們將回到自由現金流數字，即 117 億美元。

Overall, clearly, a solid yearly performance, especially given the challenging business environment we are all in.

總體而言，顯然，年度業績穩健，尤其是考慮到我們所處的商業環境充滿挑戰。

Next, let's focus on the core margins on Slide 33, again showing on the right-hand, full year; and left-hand, quarter 4. For the full year, continuing operations core margin was 31.7%, growing 280 basis points in constant currencies, with strong improvements in both divisions.

接下來，讓我們關注幻燈片 33 的核心利潤率，再次顯示在右側，全年；和左側，第 4 季度。全年，持續運營核心利潤率為 31.7%，按固定匯率計算增長 280 個基點，兩個部門都有顯著改善。

Innovative Medicines margin reached 35%, as outlooked, up 220 basis points, allowing us to achieve our previously announced mid-30s core margin target a couple of years earlier than planned.

正如預期的那樣，創新藥物利潤率達到 35%，上升 220 個基點，使我們能夠比計劃提前幾年實現我們之前宣布的 30 年代中期核心利潤率目標。

And Sandoz margin grew by 330 basis points to 24.2%.

Sandoz 的利潤率增長了 330 個基點，達到 24.2%。

Clearly, our full year margins show we are well on track to deliver on our Innovative Medicines margin targets of the high 30s in the midterm as well as our Sandoz margin target of mid- to high 20s in the midterm.

顯然，我們的全年利潤率表明我們有望在中期實現我們的創新藥物利潤率目標 30 多歲，以及山德士的中期利潤率目標為 20 多歲。

Let's go to the next slide.

讓我們轉到下一張幻燈片。

As mentioned earlier, our free cash flow for the full year was $11.7 billion, down 10% versus prior year.

如前所述，我們全年的自由現金流為 117 億美元，比上年下降 10%。

Obviously, this was because higher operating income was more than offset by the payments related to legal matters and higher divestment proceeds in the prior year.

顯然，這是因為較高的營業收入被與法律事務相關的付款和上一年較高的撤資收益所抵消。

Now turning to our full year 2021 guidance on Slide 35.

現在轉向我們關於幻燈片 35 的 2021 年全年指導。

We expect sales to grow low to mid-single-digit and core operating income to grow mid-single digit, ahead of sales driving core margin increase.

我們預計銷售額將增長低至中個位數，核心營業收入將增長中個位數，領先於銷售推動核心利潤率增長。

Within the divisions, we expect Innovative Medicine sales to grow mid-single-digit and Sandoz top line to be broadly in line with the prior year.

在各部門內，我們預計創新藥物銷售額將增長中個位數，山德士的收入將與上一年大致持平。

The Sandoz guidance is due to the impact of COVID on our retail business and expected decline of U.S. oral solid business.

山德士的指導是由於 COVID 對我們的零售業務的影響以及美國口服固體業務的預期下降。

The key assumption for this guidance, importantly, is that we see a return to normal global health care systems and prescribing dynamics by the middle of 2021.

重要的是，該指南的關鍵假設是，我們看到到 2021 年中期將恢復正常的全球醫療保健系統和處方動態。

And in addition, we assume that no Gilenya and no Sandostatin LAR generics enter in 2021 in the U.S. Please also note that the overall generic impact is expected to be in the range of the negative minus 3% of sales, similar to what we saw in 2020.

此外，我們假設 2021 年沒有 Gilenya 和 Sandostatin LAR 仿製藥進入美國 請注意，整體仿製藥的影響預計在負 3% 的銷售額範圍內，類似於我們在2020 年。

We expect there to be continued generic erosion on brands, including Afinitor, Exjade, Gleevec, also with some mature ophtha brands and Diovan.

我們預計品牌將繼續受到仿製藥侵蝕，包括 Afinitor、Exjade、Gleevec，以及一些成熟的 ophtha 品牌和 Diovan。

On Slide 36, I would like to explain the dynamics that we expect to see in quarter 1, given that we had quite a significant COVID impact last year quarter 1, which of course would impact the growth rate.

在幻燈片 36 上，我想解釋一下我們預計在第一季度看到的動態，因為我們去年第一季度對 COVID 產生了相當大的影響，這當然會影響增長率。

So as you recall, there was a significant forward purchasing in quarter 1 of last year and worth approximately 3 points of growth that largely reversed in quarter 2 with no overall impact on the full year 2020.

正如你所記得的，去年第一季度有大量的遠期採購，價值大約 3 個增長點，但在第二季度基本逆轉，對 2020 年全年沒有整體影響。

So as a result, in quarter 1 2021, we anticipate sales to decline low to mid-single digits year-on-year.

因此，在 2021 年第一季度，我們預計銷售額將同比下降低至中個位數。

The quarter 1 underlying performance, excluding the stocking effect, is expected to be broadly in line with prior year due to the continued COVID-19 impact on health care systems and patient visits.

由於 COVID-19 對醫療保健系統和患者就診的持續影響，預計第一季度的基本業績（不包括庫存效應）將與上一年基本持平。

Turning to Slide 37.

轉到幻燈片 37。

In 2021, we do expect further margin expansion, as mentioned earlier, with core operating income growth.

如前所述，我們確實預計 2021 年利潤率將進一步擴大，核心營業收入將增長。

And the magnitude, however, will be lower compared to 2020 where we increased core margins by 280 basis points.

然而，與 2020 年相比，我們將核心利潤率提高了 280 個基點，其幅度將更低。

Expected positive drivers of future core operating income growth include the continued performance of our growth drivers, the launch uptake of Kesimpta and other launches, as well as productivity programs and continuing adoption of our new ways of working.

未來核心營業收入增長的預期積極驅動因素包括我們增長驅動因素的持續表現、Kesimpta 的推出和其他推出，以及生產力計劃和繼續採用我們的新工作方式。

Growth will be partly offset by increased launch and prelaunch investments, mainly Kesimpta and Leqvio, as well as development costs for tislelizumab, which we recently in-licensed from BeiGene, of course only after the completion of the transaction.

增長將被增加的上市和上市前投資（主要是 Kesimpta 和 Leqvio）以及我們最近從百濟神州獲得許可的 tislelizumab 的開發成本部分抵消，當然只有在交易完成之後。

We will also likely see further investments into growth drivers as we expect physician access to normalize from the middle of the year.

我們也可能會看到對增長驅動因素的進一步投資，因為我們預計從年中開始，醫生的准入將正常化。

On Slide 38, I would like to add some perspective on other key financial elements of the expected quarter 1 performance.

在幻燈片 38 上，我想就第一季度預期業績的其他關鍵財務要素添加一些觀點。

As you can see, we expect core net financial expenses to be broadly in line with 2020 and also the 2021 core tax rate to be around 16%.

如您所見，我們預計核心淨財務費用與 2020 年基本持平，2021 年核心稅率約為 16%。

Next slide, please.

請下一張幻燈片。

So as you can see here on Slide 39, we are pleased to propose our 24th consecutive dividend increase to CHF 3 per share.

正如您在幻燈片 39 上看到的那樣，我們很高興提議連續 24 次將股息提高至每股 3 瑞士法郎。

This is an increase of 2%, with our dividend yield remaining above 3% and fully in line with our dividend policy of increasing our dividend every year in Swiss francs.

這增加了 2%，我們的股息收益率保持在 3% 以上，完全符合我們每年以瑞士法郎增加股息的股息政策。

And finally, on Slide 40, as currencies consistently -- constantly change, I want to bring your attention the estimated currency impact on our results using the current exchange rate.

最後，在幻燈片 40 上，由於貨幣一直 - 不斷變化，我想提請您注意使用當前匯率估計的貨幣對我們結果的影響。

So if late January rates prevail for 2021, we would see a full year impact of currencies on sales around 3% to 4% positive and our core operating income 3% positive.

因此，如果 2021 年 1 月下旬的利率佔上風，我們將看到貨幣對全年銷售額的影響約為 3% 至 4%，我們的核心營業收入為 3%。

For quarter 1, as you can see here, sales would be positive 4% and then core operating income of positive 2%.

如您在此處看到的，對於第一季度，銷售額將為正 4%，然後核心營業收入為正 2%。

And as you know, we update these expected currency impacts every month on our website.

如您所知，我們每個月都會在我們的網站上更新這些預期的貨幣影響。

With that, I hand back to Vas.

說完，我交還給瓦斯。

Great.

偉大的。

Thank you, Harry.

謝謝你，哈利。

Turning to Slide 42.

轉到幻燈片 42。

Just a final word on our ESG progress as a company.

最後談談我們作為一家公司的 ESG 進展情況。

I think as many of you know, we've placed a high priority in being a leader in our sector on ESG across our 4 main areas of focus through our materiality assessment.

我想你們很多人都知道，通過我們的重要性評估，我們將在我們的 4 個主要關注領域中成為 ESG 領域的領導者放在了高度優先地位。

Some of the highlights include the issuance of the first industry sustainability-linked bond for access to medicines.

其中一些亮點包括發行首個與行業可持續發展相關的藥品獲取債券。

Our commitment for full carbon, plastic and water neutrality by 2030.

我們承諾到 2030 年實現碳、塑料和水的完全中和。

We were just ranked today #2 in the Access to Medicines Index that was just announced and continue to see strong progress in our D&I and other corporate citizenship efforts.

我們今天剛剛在剛剛宣布的藥品獲取指數中排名第二，並且繼續看到我們的 D&I 和其他企業公民努力取得了巨大進展。

All of this has led to improvements in our ESG rankings, and we continue to work to being a leader in the ESG efforts across the sector in the years ahead.

所有這些都導致我們的 ESG 排名有所提高，我們將在未來幾年繼續努力成為整個行業 ESG 工作的領導者。

So moving to Slide 43.

所以轉到幻燈片 43。

As we noted in our Meet the Management meeting in November, we're confident we will grow top and bottom line every year to 2025 and meet external expectations of 4% growth, reaching $60 billion in sales in 2025 and reaching the consensus margin of 37.6% in 2025.

正如我們在 11 月的與管理層會面會議上指出的那樣，我們有信心到 2025 年每年實現收入和利潤增長，並達到 4% 增長的外部預期，到 2025 年銷售額達到 600 億美元，達到 37.6 的共識利潤率2025 年的百分比。

And we'll look forward to continuing to demonstrate our progress on this front as we move through the quarters ahead.

我們期待在接下來的幾個季度中繼續展示我們在這方面的進展。

So closing on Slide 44.

所以關閉幻燈片 44。

As you see, we delivered on our strategic and operational commitments and advanced our strategic priorities in 2020 despite a challenging business environment.

如您所見，儘管商業環境充滿挑戰，但我們兌現了戰略和運營承諾，並推進了 2020 年的戰略重點。

Our third year of sales, core operating income and margin improvement, I think, demonstrating the operational effectiveness of the organization.

我認為，我們第三年的銷售額、核心營業收入和利潤率的提高證明了該組織的運營效率。

We're progressing our pipeline, deep, mid- and late-stage pipeline, as well as important milestones in 2020.

我們正在推進我們的管道、深、中、後期管道，以及 2020 年的重要里程碑。

And as I noted, expect top and bottom line growth every year through 2025.

正如我所指出的，預計到 2025 年，收入和利潤每年都會增長。

So with that, we can open the line for questions.

因此，我們可以打開提問線。

(Operator Instructions) Operator?

（操作員說明）操作員？

(Operator Instructions) Your first question today comes from the line of Mark Purcell from Morgan Stanley.

（操作員說明）您今天的第一個問題來自摩根士丹利的 Mark Purcell。

It's Mark Purcell from Morgan Stanley.

是摩根士丹利的馬克·珀塞爾。

So just to -- firstly, for Harry.

所以只是為了——首先，為了哈利。

Harry, could you just help us further with the sort of phasing of growth through the course of the year?

哈利，你能不能進一步幫助我們在一年中逐步實現增長？

So as you said, for Q1, underlying growth roughly flat.

正如您所說，對於第一季度，基本增長大致持平。

Should we assume a similar thing for Q2, which sort of sets you up for 8% to 9% sales growth in the second half of the year to reach the guidance?

我們是否應該對第二季度進行類似的假設，即下半年銷售額增長 8% 至 9% 以達到指導水平？

And is there anything you see in terms of the phasing of Sandoz, which we may not have as much visibility on, which is different to that pattern?

就 Sandoz 的分階段而言，您有什麼看到的，我們可能沒有那麼多可見性，這與那個模式不同？

And then secondly, Vas, maybe one for you.

其次，Vas，也許適合你。

With tislelizumab and the BeiGene deal, obviously, this is exporting innovation out of China for -- one of the first products to do so.

顯然，通過 tislelizumab 和百濟神州的交易，這是將創新產品輸出到中國之外——這是首批這樣做的產品之一。

So is there a potential challenge here in terms of exporting the product at a lower price point when it comes to negotiating pricing agreements with governments globally?

那麼，在與全球政府談判定價協議時，以較低的價格出口產品是否存在潛在挑戰？

Or is the lower price points in China potentially something you could use to your advantage when it comes to transferring the value into potential combinations of your next-generation assets?

或者，在將價值轉移到您的下一代資產的潛在組合中時，您是否可以利用中國較低的價格點來發揮您的優勢？

So thinking things such as TIM-3, SHP2, CD73, et cetera.

所以思考諸如 TIM-3、SHP2、CD73 等之類的東西。

So it would be useful to get some context there.

因此，在那裡獲得一些上下文會很有用。

Terrific.

了不起。

Thanks, Mark.

謝謝，馬克。

Harry, on phasing of growth?

哈利，關於成長階段？

Yes.

是的。

Thank you, Mark.

謝謝你，馬克。

Yes, the last year was quite interesting with the forward buy, if you will, as health care systems try to get some inventory and also at the patient level, longer scripts have been given.

是的，如果你願意的話，去年的遠期購買非常有趣，因為醫療保健系統試圖獲得一些庫存，而且在患者層面，已經給出了更長的腳本。

So we have this $400 million roughly effect of forward buy or stocking in quarter 1 and then they destocked in quarter 2. That's roughly 3 points on our quarter.

因此，我們有這 4 億美元的大致影響，即第一季度的遠期購買或庫存，然後他們在第二季度去庫存。這大約是我們季度的 3 個點。

So of course, then quarter 2 would have the reversed positive effect.

因此，當然，第 2 季度將產生相反的積極影響。

Another effect we had in quarter 2 is that Lucentis, basically, many patients skipped or doctors skipped 1 injection.

我們在第 2 季度產生的另一個影響是 Lucentis，基本上，許多患者跳過或醫生跳過 1 次注射。

That's now fully back.

現在完全恢復了。

So quarter 2, we should see some good growth.

所以第二季度，我們應該會看到一些不錯的增長。

And so the first half, I would say, we do expect to be broadly in line with prior year, maybe low single-digit growth as totality, right?

所以上半年，我會說，我們確實預計與上一年基本持平，可能是整體的低個位數增長，對吧？

First, decline in quarter 1 and then some good growth in quarter 2 is the expectation.

首先，第一季度下降，然後第二季度出現一些良好的增長是預期。

That is broadly in line with prior year, especially what we have seen in the last 2 quarters.

這與去年大體一致，尤其是我們在過去兩個季度看到的情況。

And as you think about the second half of 2020, quarter 3 was 0, quarter 4 was plus 1%.

想想 2020 年下半年，第 3 季度為 0，第 4 季度為 1%。

And that was the environment that we expect the next couple of quarters to be in.

這就是我們預計接下來幾個季度的環境。

So that's why we believe that is a reasonable scenario.

所以這就是為什麼我們認為這是一個合理的情況。

Of course, it is unprecedented volatility.

當然，這是前所未有的波動。

And therefore, we have to plan in different scenarios.

因此，我們必須在不同的情況下進行計劃。

So then, as you say, in the second half, we do expect some very good growth.

那麼，正如你所說，在下半年，我們確實預計會有一些非常好的增長。

But again, we talk ranges and have to see how quickly then the health care systems open up.

但同樣，我們談論範圍，必須看看醫療保健系統開放的速度有多快。

So I think that phasing of half 1, half 2. And then if you have to do this quarter 1 stocking, quarter 2 destocking of last year, should give a good feeling for how to model the quarters.

所以我認為分階段進行半 1，半 2。然後，如果您必須在去年的第 1 季度庫存，第 2 季度去庫存，應該對如何建模季度有一個很好的感覺。

I don't want to get into Innovative Medicines as well as Sandoz, I think we get too granular.

我不想像 Sandoz 一樣涉足創新藥物，我認為我們太細化了。

But you have seen last year, the quarter 1, quarter 2 of both divisions, and I think that should be helpful.

但是你在去年看到了兩個部門的第一季度和第二季度，我認為這應該會有所幫助。

Thanks, Harry.

謝謝，哈利。

On tislelizumab, broadly speaking, our goal is to maximize the value of this asset.

在 tislelizumab 上，從廣義上講，我們的目標是最大化這項資產的價值。

We have an asset that can participate in the $50 billion-plus PD-1 market around the world.

我們擁有可以參與全球超過 500 億美元的 PD-1 市場的資產。

We have the full commercial flexibility to maximize the value of the product.

我們擁有充分的商業靈活性來最大化產品的價值。

And then our goal, of course, is to leverage the medicine across the full combinations possible across Novartis' oncology portfolio.

當然，我們的目標是在諾華（Novartis）腫瘤學產品組合中的所有可能組合中利用該藥物。

So we have a number of combination studies already planned, and we believe having a hopefully soon-approved PD-1 in U.S. and then later also in Europe will enable us to accelerate our own combination programs across the full range of our portfolio.

因此，我們已經計劃了許多聯合研究，我們相信希望很快在美國和歐洲獲得批准的 PD-1 將使我們能夠在我們的整個產品組合中加速我們自己的聯合計劃。

I can't comment, and it's too soon, I think, and premature to comment on pricing strategies, et cetera.

我無法發表評論，我認為現在評論定價策略等還為時過早。

But I think once the deal closes and we're further along, we can, of course, provide more granularity, and Susanne can provide more granularity on our commercial strategies.

但我認為，一旦交易完成並且我們繼續前進，我們當然可以提供更多的粒度，而蘇珊可以為我們的商業策略提供更多的粒度。

Your next question comes from the line of Laura Sutcliffe from UBS.

您的下一個問題來自瑞銀的 Laura Sutcliffe。

Two product-specific questions, please.

兩個產品特定的問題，請。

Firstly, for Zolgensma in the U.S., I think you said at your last set of results that you had 74% newborn coverage, and your goal now is, I think, 80% by the end of the year, if I heard it right.

首先，對於美國的 Zolgensma，我認為您在上一組結果中說過您有 74% 的新生兒覆蓋率，如果我沒聽錯的話，我認為您現在的目標是到今年年底達到 80%。

Does that mean that you think that access is only really going to expand sort of incrementally in the U.S. this year?

這是否意味著您認為今年美國的訪問量只會逐漸增加？

And sort of in practical terms, there won't be very much extra?

實際上，不會有太多額外的東西嗎？

Or is there a more optimistic scenario in there?

還是那裡有更樂觀的情況？

And then secondly on Kesimpta.

然後是凱辛普塔。

Do you have a rough idea of when you expect that you'll start to see the majority of sales come from paid for products rather than free products?

您是否有一個粗略的想法，您預計何時會開始看到大部分銷售來自付費產品而不是免費產品？

Yes.

是的。

Thanks, Laura.

謝謝，勞拉。

So on Zolgensma, what we ended up seeing in 2020 was newborn screening coverage in the U.S. in the high 60s.

所以在 Zolgensma 上，我們最終在 2020 年看到的是美國 60 年代的新生兒篩查覆蓋率。

And our goal is to get that into the high 80s in -- over the course of 2021.

我們的目標是在 2021 年達到 80 年代的最高水平。

And in that setting, we would expect, again, Zolgensma to have a very high market share in states that have newborn screening.

在這種情況下，我們再次期望 Zolgensma 在進行新生兒篩查的州擁有非常高的市場份額。

Alongside that, we also are working hard to get better -- even further Medicaid coverage with hopefully getting a significant number of additional states fully putting in place Medicaid programs.

除此之外，我們還在努力變得更好 - 甚至進一步覆蓋醫療補助計劃，希望讓更多的州充分實施醫療補助計劃。

So we haven't seen this as a significant barrier.

因此，我們還沒有將其視為重大障礙。

We do think that will ease the ability to get patients started.

我們確實認為這將減輕讓患者開始的能力。

I would still say, in general, I mean, the biggest constraint right now on Zolgensma growth is more the pandemic than the underlying demand.

我仍然會說，總的來說，我的意思是，目前對 Zolgensma 增長的最大限制更多的是流行病而不是潛在需求。

We see very good dynamics, very solid AAV testing rates around the world.

我們在全球範圍內看到了非常好的動態、非常穩定的 AAV 測試率。

We see a strong interest for governments to put in place reimbursement programs, but it does take more time in the pandemic.

我們看到政府對實施報銷計劃有濃厚的興趣，但在大流行中確實需要更多時間。

We do see physicians delaying starts with Zolgensma simply because of the initiation procedures involved with such a therapy.

我們確實看到醫生推遲開始使用 Zolgensma 僅僅是因為這種療法涉及的啟動程序。

So we're hopeful that as the pandemic recedes or health care systems stabilize, we'll see an acceleration over the course of the year.

因此，我們希望隨著大流行的消退或醫療保健系統的穩定，我們將在一年中看到加速。

Now turning to Kesimpta, Marie-France?

現在轉向 Marie-France 的 Kesimpta？

So thank you, Laura.

所以謝謝你，勞拉。

Our bridging program is available for commercial patients for up to 12 months.

我們的橋接計劃可供商業患者使用長達 12 個月。

So we've had a generous program, and I can tell you that the majority of Kesimpta patients are currently on this bridging program.

所以我們有一個慷慨的計劃，我可以告訴你，大多數 Kesimpta 患者目前都在這個橋接計劃中。

We expect the conversion to paid products with share of free goods to decline from 70% to 30% over the course of the year, and that will obviously drive up the sales ramp-up.

我們預計，在這一年中，免費商品份額的付費產品轉換率將從 70% 下降到 30%，這顯然會推動銷售增長。

What's important here is that we expect 3 quarters of the '21 sales to be realized in the second half of the year.

這裡重要的是，我們預計 21 年銷售額的 3 個季度將在今年下半年實現。

And this, of course, assumes the pandemic recovery in line with our group guidance.

當然，這假設大流行恢復符合我們的集團指導。

What I can say in the meantime is that the team is doing an incredible job with the launch.

與此同時，我能說的是，團隊在發布方面做得非常出色。

We've seen access, and we beat our own internal benchmarks on access.

我們已經看到了訪問權限，並且我們在訪問權限方面擊敗了我們自己的內部基準。

We're seeing naive patients at 17%.

我們看到 17% 的天真患者。

We have leading share of attention.

我們擁有領先的關注度。

We've made sure that we focus on making fast initiations and making it easy.

我們確保我們專注於快速啟動並使其變得容易。

So we're in good shape.

所以我們的狀態很好。

We're building the foundation.

我們正在建立基礎。

We have a good free goods program.

我們有一個很好的免費商品計劃。

And we're hoping to accelerate the sales in the second half of the year.

我們希望在下半年加速銷售。

Your next question comes from the line of Matthew Weston from Crédit Suisse.

您的下一個問題來自瑞士信貸的 Matthew Weston。

Two questions, please.

請教兩個問題。

One, Vas, at the CMD in late November, you expressed confidence in consensus.

一，Vas，在 11 月下旬的 CMD 上，你表達了對共識的信心。

And I think a lot of investors took that to mean each year rather than just 2025.

而且我認為很多投資者都認為這意味著每年，而不僅僅是 2025 年。

Now the '21 guide seems to be somewhat below consensus.

現在，'21 指南似乎有點低於共識。

So you obviously had good visibility on the challenges of COVID in late November.

因此，您顯然對 11 月下旬的 COVID 挑戰有很好的了解。

So can you just tell people if there is anything that's fundamentally changed since late November?

那麼，您能否告訴人們自 11 月下旬以來是否發生了根本性的變化？

Or really, it's just the pattern of growth out to 2025 that potentially was misinterpreted.

或者說真的，只是到 2025 年的增長模式可能被誤解了。

And then secondly, on Entresto in PEF, again just referencing that Meet Management.

其次，在 PEF 的 Entresto 上，再次引用 Meet Management。

You put it in the $500 million to $1 billion peak sales bucket.

你把它放在 5 億到 10 億美元的銷售高峰期。

Now that you've heard the AdComm commentary, and you've obviously had further interaction with FDA, do you think that peak sales potential is conservative given the number of patients that you've just laid out in the presentation today?

既然您已經聽過 AdComm 的評論，並且您顯然與 FDA 進行了進一步的互動，您認為考慮到您今天在演示文稿中列出的患者數量，峰值銷售潛力是否保守？

Yes.

是的。

Thanks, Matthew.

謝謝，馬修。

On the first point, our intention in Meet the Management was to provide confidence over the 5-year period and not to provide any sort of annual milestones with respect to consensus.

關於第一點，我們與管理層會面的目的是在 5 年期間提供信心，而不是提供任何形式的年度里程碑來達成共識。

So certainly, if that was misinterpreted, I apologize that we were not clear enough.

所以當然，如果這被誤解了，我很抱歉我們不夠清楚。

I think what we did say is we plan to consistently grow sales and core operating income.

我認為我們所說的是我們計劃持續增加銷售額和核心營業收入。

We do that this year.

我們今年這樣做。

We grew core operating income ahead of sales.

我們在銷售之前增加了核心營業收入。

We also have tried to be consistent that the margin progression will not be at a steady pace, but we will get to the high 30s as we outlined as well.

我們還試圖保持一致，即利潤率增長不會以穩定的速度增長，但我們也將達到我們概述的 30 多歲。

So I think we're on track.

所以我認為我們正在走上正軌。

Nothing fundamentally has changed.

從根本上沒有改變。

And when I -- when we look at that 4% growth out to 2025 and the margin out to rounded 38%, we feel very good with our ability to achieve that with the portfolio that we have in hand.

當我看到到 2025 年的 4% 增長和 38% 的利潤率時，我們對我們手頭的投資組合實現這一目標的能力感到非常滿意。

Now with respect to HFpEF, maybe I'll turn it over to Marie-France to give a little bit of the range of patient numbers and potential.

現在關於 HFpEF，也許我會將其交給 Marie-France，以提供一些患者人數和潛力的範圍。

Thank you, Vas.

謝謝你，瓦斯。

So the AdComm discussion really reinforced the unmet need for Entresto's value in the treatment of PEF.

因此，AdComm 討論確實強化了 Entresto 在 PEF 治療中的價值未得到滿足的需求。

And we see this specifically in this group of patients with ejection fraction [before] normal.

我們在這組射血分數正常的患者中特別看到了這一點。

But it's difficult at this point to give you a specific range because that's going to depend on the addressable patient pool, which will obviously depend on the label.

但在這一點上很難給你一個具體的範圍，因為這將取決於可尋址的患者池，這顯然取決於標籤。

What I can say is that the total PEF population is about 3 million patients in the U.S. and about 2 million of them have an ejection fraction below normal.

我能說的是，美國的 PEF 患者總數約為 300 萬，其中約 200 萬的射血分數低於正常值。

We also know in this market, and this is critical, I referenced it before, that it's important to have guidelines.

我們也知道在這個市場上，這很重要，我之前提到過，有指導方針很重要。

So our uptake is going to be gradual as those guidelines are updated, and we're going to continue to keep our consensus around $4 billion to $5 billion for total Entresto sales.

因此，隨著這些指導方針的更新，我們的採用將是漸進的，我們將繼續保持 Entresto 總銷售額在 40 億至 50 億美元左右的共識。

So we previously guided $3 billion to $4 billion on rEFs, and we are guiding $4 billion to $5 billion on rEFs and PEFs together.

因此，我們之前在 rEF 上指導了 30 億到 40 億美元，現在我們在 rEF 和 PEF 上指導了 40 到 50 億美元。

Your next question comes from the line of Steve Scala from Cowen.

您的下一個問題來自 Cowen 的 Steve Scala。

The inclisiran situation in the U.S. is perplexing.

美國的 inclisiran 局勢令人困惑。

2 months ago, Novartis had been anticipating a year-end 2020 approval, then said the facility review only related to paperwork and might not be needed.

2 個月前，諾華一直在期待 2020 年年底的批准，然後表示設施審查僅與文書工作有關，可能不需要。

And now the product appears delayed a year in the U.S. So something seems not right, and I'm wondering what perspective you can add.

現在該產品在美國似乎延遲了一年。所以似乎有些不對勁，我想知道您可以添加什麼觀點。

The second question, Vas, you said Zolgensma potential was $2 billion.

第二個問題，Vas，你說 Zolgensma 的潛力是 20 億美元。

Is that the first time Novartis has provided that number?

這是諾華第一次提供這個數字嗎？

And what does that include for addressable SMA patient groups as well as other indications?

對於可尋址的 SMA 患者群體以及其他適應症，這包括什麼？

Yes.

是的。

Thanks, Steve.

謝謝，史蒂夫。

On the inclisiran topic, it's been certainly an interesting journey for us as well.

關於 inclisiran 話題，這對我們來說當然也是一段有趣的旅程。

I mean, this is a situation where we had a facility.

我的意思是，這是我們有設施的情況。

Routine inspection would have happened in May.

例行檢查將在五月進行。

Due to the pandemic, the FDA converted this to a paper-based inspection.

由於大流行，FDA 將其轉換為紙質檢查。

The third party provided the documentation, and the entire interaction has been purely based in writing.

第三方提供了文檔，整個交互完全基於書面形式。

There have been no verbal conversations.

沒有任何口頭對話。

And these, of course, have happened in writing with the third-party facility.

當然，這些都是通過第三方設施以書面形式發生的。

Our best estimates over the course of last year were based on our discussions with the review team and our understanding that there were no safety, efficacy or CMC-related concerns that were product-specific.

我們對去年的最佳估計是基於我們與審查小組的討論以及我們對產品特定的安全性、有效性或 CMC 相關問題的理解。

We ultimately all learned, and we did it as well with the CRL, that FDA wanted additional documentation and some additional control changes within this facility.

我們最終都了解到，並且我們在 CRL 中也做到了，FDA 想要在該設施內獲得額外的文件和一些額外的控制變更。

It's notable this facility is approved in our European Medicines file, fully approved and part of the launch network for the launch of Leqvio in Europe.

值得注意的是，該設施已在我們的歐洲藥品文件中獲得批准，完全獲得批准，並且是在歐洲推出 Leqvio 的發射網絡的一部分。

We're working as fast as we can with the third party.

我們正在盡可能快地與第三方合作。

Ultimately, it's the third party's responsibility to provide answers to those questions to the FDA.

最終，第三方有責任向 FDA 提供這些問題的答案。

I think we're trying to provide realistic guidance, given that we're in a pandemic, of Q2 to Q3.

鑑於我們正處於第二季度至第三季度的大流行中，我認為我們正在努力提供現實的指導。

And then it will be up to the FDA ultimately to determine if they still want an in-person inspection, when they want to conduct that inspection and how long they take to complete that process and the review.

然後由 FDA 最終決定他們是否仍需要親自檢查、何時進行檢查以及完成該過程和審查需要多長時間。

I mean, that's -- those are the facts as we know them, and we'll continue to work as fast as we can to get this medicine approved in the U.S. and launched.

我的意思是，這就是我們所知道的事實，我們將繼續盡快讓這種藥物在美國獲得批准並上市。

I think what's important is what Marie-France and the team mentioned, what she mentioned.

我認為重要的是 Marie-France 和團隊提到的，她提到的。

If anything, this is an opportunity for us to prepare even better for the launch.

如果有的話，這是我們為發布做更好準備的機會。

We don't have to launch this medicine in the midst of a pandemic.

我們不必在大流行期間推出這種藥物。

We have the opportunity now to build an even stronger launch-preparedness effort and then hopefully get off to a strong start as soon as the product is approved.

我們現在有機會建立更強大的發布準備工作，然後希望在產品獲得批准後儘快開始。

With respect to Zolgensma, I think historically, we've said that we're comfortable with the 2025 consensus, which I believe is in that range of $1.9 billion to $2 billion.

關於 Zolgensma，我認為從歷史上看，我們已經說過我們對 2025 年的共識感到滿意，我認為該共識在 19 億美元到 20 億美元之間。

And so that's the basis of this -- of the comment that I made.

這就是我發表評論的基礎。

It's based on Zolgensma IV and based on Zolgensma IV in the current indications of under 2 years old in the U.S. and up to 22 kilograms outside of the U.S. As I mentioned, we continue to work for -- to get AVXS-101 IT fully licensed, and we'll keep -- we'll give you an update once we clear the preclinical topic and finalize the Phase III development program.

它基於 Zolgensma IV 和基於 Zolgensma IV 在美國的當前適應症為 2 歲以下和美國以外的 22 公斤 正如我所提到的，我們繼續努力 - 獲得 AVXS-101 IT 完全許可，並且我們將繼續 - 一旦我們明確臨床前主題並完成 III 期開發計劃，我們將為您提供更新。

Your next question comes from the line of Graham Parry, Bank of America.

您的下一個問題來自美國銀行的 Graham Parry。

So firstly, a question on COVID impact on your '21 guide.

因此，首先，關於 COVID 對您的 '21 指南的影響的問題。

So roughly, how many percentage points do you think COVID is negatively impacting revenue growth in 2021?

粗略地說，您認為 COVID 對 2021 年的收入增長有多少個百分點的負面影響？

And on margins, how much wiggle room are you giving yourselves there given the likelihood that you are going to get more COVID savings?

在利潤方面，考慮到您將獲得更多 COVID 儲蓄的可能性，您給自己提供了多少迴旋餘地？

So as we look into '22, you're really setting yourselves up here for quite an easy base for '22 growth.

因此，當我們研究 22 年時，您真的在這里為 22 年的增長奠定了相當容易的基礎。

And then secondly, a question on CANOPY-1.

其次，關於 CANOPY-1 的問題。

There's been quite a lot of investor discussion around timing of interims.

圍繞中期的時間安排，投資者進行了很多討論。

I think some investors interpreted management comments made recently that there's definitely no interims in first half of '21.

我認為一些投資者解釋了最近發表的管理層評論，即 21 年上半年肯定沒有中期。

So can you clarify if that's correct?

那你能澄清一下這是否正確嗎？

Or if you're just saying you're just not disclosing timing?

或者，如果你只是說你只是沒有透露時間？

And just leave us guessing if it could happen at any point between now and the final analysis in Q4?

讓我們猜測它是否會在從現在到第四季度的最終分析之間的任何時候發生？

Thanks, Graham.

謝謝，格雷厄姆。

On COVID-19 impact, I'll give it to Harry.

關於 COVID-19 的影響，我會把它交給哈利。

Harry?

哈利？

Thank you very much, Graham.

非常感謝你，格雷厄姆。

So very exact numbers are hard to grab, right, on what is purely COVID?

所以很難掌握非常準確的數字，對，什麼是純粹的 COVID？

But as we compare to our forecast and of course the analytics around it, which we're doing constantly, I would say, starting with the impact we experienced in 2020, between 2 and 3 percent points of sales growth, we would attribute as a negative.

但是，當我們與我們的預測以及圍繞它的分析進行比較時，我想說，從我們在 2020 年所經歷的影響開始，銷售增長在 2% 到 3% 之間，我們將其歸因於消極的。

On the bottom line, given the cost discipline as well as some of the natural underspend, as you have seen, we have made up more than that.

歸根結底，鑑於成本紀律以及一些自然支出不足，正如您所見，我們已經彌補了更多。

And it could even increase our core operating income guidance.

它甚至可以增加我們的核心營業收入指導。

Now for 2021, the half year effect, we have some -- a little under 2% on the top line is what we expect.

現在對於 2021 年的半年效應，我們有一些——我們預期的收入略低於 2%。

So again, it depends very much on quarter 2, quarter 3 grow.

因此，這在很大程度上取決於第二季度、第三季度的增長。

We have several scenarios which we try to put here on the guidance.

我們有幾個場景，我們試圖把這些場景放在指南中。

Never easy.

從來都不容易。

But I think we have to be a bit careful around when our patient visits and initiations back to pre-COVID normal, which we do expect as of the summer as of Q3.

但我認為，當我們的患者就診和開始恢復到 COVID 之前的正常狀態時，我們必須要小心一點，我們確實預計到第三季度的夏季會出現這種情況。

And then on the bottom line, I just want to mention one thing.

最後，我只想提一件事。

As you know, right, we had significant savings and underspend.

如您所知，是的，我們節省了大量資金，但支出不足。

Of course, we keep our ways of working, saving on travel and internal meetings and so on, leveraging digital.

當然，我們保持我們的工作方式，節省旅行和內部會議等，利用數字化。

But we have basically put that into the base for '21 on the cost side, right?

但是我們基本上已經把它放在成本方面的 21 年的基礎上，對吧？

And now to assume we can do a significant effort like this again on top of already quite a lot of savings in 2020, one has to be careful that we would not underinvest into the launches and prelaunches.

現在假設我們可以在 2020 年已經節省大量資金的基礎上再次做出這樣的重大努力，我們必須小心，不要對發射和預發射進行投資不足。

So we clearly see margin improvement, but after 280 basis points here in constant currencies, to -- we have to also ensure we have the right level of investments as we expect the markets will open up for more face-to-face promotion also as of the summer.

因此，我們清楚地看到利潤率有所改善，但在以固定貨幣計算 280 個基點之後，我們還必須確保我們擁有正確的投資水平，因為我們預計市場也將開放以進行更多的面對面促銷的夏天。

Thanks, Harry.

謝謝，哈利。

And then on the interim guidance, maybe rather than getting specific on CANOPY-1, in general, we have interim data readouts across our programs and we're no longer disclosing the timing of those interim readouts.

然後在臨時指南中，一般來說，我們可能沒有具體說明 CANOPY-1，而是在我們的程序中進行臨時數據讀數，並且我們不再披露這些臨時讀數的時間。

We'd rather have investors focus on the full data readout -- full timing of data readouts based on the powering of these studies.

我們寧願讓投資者關注完整的數據讀出——基於這些研究的支持的數據讀出的完整時間。

They're powered, of course, to read out at the close of the study.

當然，它們有能力在研究結束時讀出。

And so we continue to guide to CANOPY-2 in the first half, CANOPY-1 in the second half, CANOPY-Adjuvant in '22.

所以我們繼續在上半年指導 CANOPY-2，在下半年指導 CANOPY-1，在 22 年指導 CANOPY-Adjuvant。

Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank.

您的下一個問題來自德意志銀行的 Emmanuel Papadakis。

Emmanuel Papadakis from Deutsche Bank.

德意志銀行的 Emmanuel Papadakis。

A couple of questions, please.

有幾個問題，請。

Perhaps the first one I could take is on the SHP2, just if you could give us a bit of clarity in terms of timing, when we might see that first KRAS combination data.

也許我可以採取的第一個是在 SHP2 上，只要您能在時間方面給我們一些明確的說明，我們可能會看到第一個 KRAS 組合數據。

I know you've been in the clinic since Q2 last year with your partner in the U.S., Mirati.

我知道您自去年第二季度以來一直與您在美國的合作夥伴 Mirati 一起在診所工作。

So just comment on timing and the degree of confidence you have based on the data you've presumably seen in house, that will have a major role to play in the future targeted lung therapy space.

因此，只需根據您可能在內部看到的數據評論您的時間和信心程度，這將在未來的靶向肺治療領域發揮重要作用。

And then perhaps a second on the iptacopan breakthrough designation in PNH and C3G.

然後可能是 PNH 和 C3G 中 iptacopan 突破性指定的第二個。

Alexion has been historically quite clear, they don't expect the oral complement assets to challenge C5 agents as the mainstay therapy, rather only in refractory patients or those with breakthrough hemolysis.

Alexion 在歷史上一直很清楚，他們不認為口服補體資產會挑戰 C5 藥物作為主要治療方法，而僅適用於難治性患者或突破性溶血患者。

So would you disagree with that view?

那麼你會不同意這種觀點嗎？

Was the breakthrough designation also covering naive patients or just the refractory subgroups, for example?

例如，突破性指定是否也涵蓋幼稚患者或僅涵蓋難治性亞組？

And just a bit of thoughts in terms of the midterm outlook in that space?

就該領域的中期前景而言，只是一些想法？

And then maybe if I could just tack on.

然後也許我可以繼續。

In C3G, we've had reasonably promising Phase II data from avacopan in the ACCOLADE study in December.

在 C3G 中，我們在 12 月的 ACCOLADE 研究中從 avacopan 獲得了相當有希望的 II 期數據。

The company there is talking about potential for filing.

那裡的公司正在談論申請的潛力。

That would put you very significantly behind.

那會讓你大大落後。

So just timings and indeed differentiation on that side of things as well would be helpful.

因此，僅在這方面進行時間安排和差異化也會有所幫助。

Thanks, Emmanuel.

謝謝，伊曼紐爾。

So on the SHP2, John?

那麼在 SHP2 上，約翰？

Yes, sure.

是的，當然。

Thanks for the question, Emmanuel.

謝謝你的問題，伊曼紐爾。

On the SHP2 inhibitor, we've been working with Mirati.

在 SHP2 抑製劑方面，我們一直在與 Mirati 合作。

And we have a clinical collaboration in terms of moving forward.

我們在前進方面進行了臨床合作。

We've had a couple of patients in combination with their KRAS G12C, adagrasib.

我們已經有幾位患者與他們的 KRAS G12C adagrasib 聯合使用。

We're beginning to see the initial results.

我們開始看到初步結果。

I think there was 1 case study that was presented at an oncology conference at the end of the year last year.

我認為去年年底在腫瘤學會議上提出了 1 個案例研究。

We hope to reach proof-of-concept later this year and move forward based on those results.

我們希望在今年晚些時候實現概念驗證，並根據這些結果繼續前進。

So the exact timing in terms of the Phase II and Phase IIIs will be forthcoming in probably the mid -- this time, middle of this year is how we would move forward.

因此，第二階段和第三階段的確切時間可能會在年中公佈——這一次，今年年中是我們前進的方式。

So -- also, I think you had a number of questions regarding iptacopan.

所以--另外，我認為您對iptacopan 有很多問題。

And I believe, specifically, you were asking about our approach with iptacopan in PNH and combinations.

我相信，具體來說，您是在詢問我們在 PNH 和組合中使用 iptacopan 的方法。

As -- and just for the folks online here, iptacopan is our first-in-class complement B -- factor B inhibitor that acts upstream of C3 and C5.

正如 - 並且僅針對在線的人們，iptacopan 是我們一流的補體 B - B 因子抑製劑，作用於 C3 和 C5 的上游。

And as Alexion has their anti-C5, what we note is that we're targeting both intravascular hemolysis, which is the C5 inhibitors which target the intravascular, but we also target the C3.

由於 Alexion 有他們的抗 C5，我們注意到我們同時針對血管內溶血，即針對血管內的 C5 抑製劑，但我們也針對 C3。

So we know that about 70% of the patients currently who have PNH are inadequately controlled with C5 inhibitors.

所以我們知道，目前大約 70% 的 PNH 患者使用 C5 抑製劑無法充分控制。

So we have designed a superiority trial in terms of moving forward in -- so we do feel like that would be a superiority trial that would give us the indication to move forward in single agent.

因此，我們已經設計了一個在推進方面的優勢試驗——所以我們確實覺得這將是一個優勢試驗，會給我們在單一代理方面推進的指示。

And then, John, avacopan and C3G, I think that's a C5 inhibitor.

然後，John、avacopan 和 C3G，我認為這是一種 C5 抑製劑。

So I think that's acting downstream, if I'm not mistaken.

因此，如果我沒記錯的話，我認為這是在下游作用。

Exactly.

確切地。

That is downstream.

那是下游。

And Emmanuel, I think you had a third question on IgA.

還有Emmanuel，我想你有關於IgA 的第三個問題。

If you could just ask that question because I didn't write down that specific third question.

如果你能問這個問題，因為我沒有寫下具體的第三個問題。

No, John.

不，約翰。

That was a question on timing of C3G and when we would plan to get to a filing in C3G for iptacopan.

那是關於 C3G 的時間安排以及我們計劃何時在 C3G 中為 iptacopan 提交文件的問題。

Yes.

是的。

So for iptacopan in C3G, what we've noted is that we have a Phase II data readout in the first half of this year.

因此，對於 C3G 中的 iptacopan，我們注意到的是，我們在今年上半年進行了第二階段的數據讀出。

And based on that, we're looking to move forward in a potential Phase III program and potential filing next year -- or 2023.

基於此，我們希望在明年或 2023 年推進潛在的第三階段計劃和潛在的申請。

And I just want to highlight again for iptacopan.

我只想再次強調 iptacopan。

Our goal is a first-line indication.

我們的目標是一線指示。

I think Susanne and her team have a strong hematology presence in the U.S. So we believe we can launch this product successfully in first line with respect to PNH and then of course in the full range of indications in the coming year.

我認為 Susanne 和她的團隊在美國擁有強大的血液學影響力。因此，我們相信我們可以在 PNH 的一線成功推出該產品，然後當然是在來年的所有適應症中。

Your next question comes from the line of Richard Parkes from Exane BNP.

您的下一個問題來自 Exane BNP 的 Richard Parkes。

Two questions.

兩個問題。

Firstly, on Kesimpta.

首先，關於凱辛普塔。

I just wondered to what degree the launch and the class overall is being impacted by patients delaying treatment initiation due to either worries over immunosuppression or lack of -- potential lack of response to COVID vaccination.

我只是想知道，由於擔心免疫抑製或缺乏對 COVID 疫苗接種的潛在反應，患者延遲治療開始對啟動和整個課程的影響有多大。

I've noticed a couple of recent publications underlying a 2x increased risk of severe COVID with B-cell depleted.

我注意到最近的一些出版物表明 B 細胞耗盡的嚴重 COVID 風險增加了 2 倍。

So just wondered if you could comment on that and what degree that impact on the class might linger longer term as we come out of the pandemic.

因此，只是想知道您是否可以對此發表評論，以及隨著我們擺脫大流行，這種影響可能會在長期內持續多久。

And then secondly, on Entresto, just a clarification.

其次，關於 Entresto，只是一個澄清。

Based on the patient populations that you're pointing to for the preserved ejection fraction indication, it sounds like you think the labeling discussions will be around kind of ejection fraction cutoffs rather than necessarily restricting by sex.

根據您針對保留射血分數指示所指向的患者人群，聽起來您認為標籤討論將圍繞射血分數截止值而不是必然受到性別限制。

So I just wondered if you could confirm that.

所以我只是想知道你是否可以證實這一點。

And if you are able to quantify what you think the opportunity for Entresto is in the PARADISE-MI setting, that would be really helpful.

如果你能夠量化你認為 Entresto 在 PARADISE-MI 環境中的機會，那將非常有幫助。

So Marie-France, both on Kesimpta and Entresto.

所以 Marie-France，在 Kesimpta 和 Entresto 上。

Yes.

是的。

So on Kesimpta, I think the important thing is that we're really leaving no stone unturned in this launch.

所以在 Kesimpta，我認為重要的是我們在這次發布中真的不遺餘力。

And as I mentioned before, I think we're in pretty good shape on all our metrics to really bring this product as a first-line DMT to market.

正如我之前提到的，我認為我們在所有指標上都處於非常好的狀態，可以真正將這款產品作為一線 DMT 推向市場。

We are however feeling the effects of the pandemic, and you can see that mostly in the overall ability of our teams to perform their patient visits.

但是，我們正在感受到大流行的影響，您可以從我們團隊進行患者就診的整體能力中看到這一點。

Now there is some noise in the market around vaccination or delaying hesitation by HCPs on switching therapies, and that is a reality that we're seeing right now.

現在市場上有一些關於疫苗接種或 HCP 推遲對轉換療法猶豫不決的噪音，這是我們現在看到的現實。

However, what I can say is that we are currently running some clinical trials in vaccinations.

但是，我可以說的是，我們目前正在進行一些疫苗接種臨床試驗。

We also have data in this regard, looking at other vaccinations in B-cell therapies and in other biologics that give us confidence that we'll be able to make sure that patients and physicians feel comfortable with using Kesimpta in -- regardless of COVID and regardless of vaccination.

我們也有這方面的數據，研究 B 細胞療法和其他生物製劑中的其他疫苗接種，這讓我們有信心確保患者和醫生對使用 Kesimpta 感到滿意——無論 COVID 和與疫苗無關。

So there are currently a lot of real-world evidence databases that are quite encouraging.

因此，目前有很多真實世界的證據數據庫非常令人鼓舞。

We're looking at this not only for Kesimpta, but across the broad range of products, including Cosentyx as well.

我們不僅關注 Kesimpta，還關注包括 Cosentyx 在內的廣泛產品。

The important thing is that patients get treated.

重要的是患者得到治療。

And despite the fact that our selling cycle is a little longer, we're not slowing down.

儘管我們的銷售週期有點長，但我們並沒有放慢腳步。

We're continuing to build the foundation for this product.

我們正在繼續為該產品奠定基礎。

And I do believe that you can expect to see the B-cell market grow significantly, not only because of the work that we're doing, but because this is really bringing a high-efficacy therapy to patients upfront, and that could radically change the way that physicians think about and treat multiple sclerosis patients.

而且我相信你可以期待看到 B 細胞市場顯著增長，這不僅是因為我們正在做的工作，而且因為這確實為患者帶來了高效的治療方法，這可能會發生根本性的變化醫生思考和治療多發性硬化症患者的方式。

So we've said that we are ready.

所以我們說我們準備好了。

We just need this market to bounce back.

我們只需要這個市場反彈。

And then Marie-France, on the Entresto HFpEF ejection fraction versus male/female, and then also PARADISE-MI potential.

然後是 Marie-France，關於 Entresto HFpEF 射血分數與男性/女性的對比，然後還有 PARADISE-MI 潛力。

So when we go back to what I said before, it really depends on the addressable pool of patients.

因此，當我們回到我之前所說的內容時，這實際上取決於可尋址的患者群體。

We're very encouraged by the conversations that we've heard coming out of the AdComm, and now we're in discussions with FDA around the exact wording of the label.

我們對從 AdComm 中聽到的對話感到非常鼓舞，現在我們正在與 FDA 就標籤的確切措辭進行討論。

And it will depend on the patient pool.

這將取決於患者池。

As I said before, this is a significant population, but it's also an underdiagnosed population, so we'll have to take things as it comes.

正如我之前所說，這是一個重要的人群，但它也是一個未被充分診斷的人群，所以我們必須順其自然。

It's very encouraging, as we have seen from the PARAGON data, that there are groups of patients that do benefit.

正如我們從 PARAGON 數據中看到的那樣，令人鼓舞的是，確實有一些患者群體從中受益。

And there's a general consensus with physicians that this is not an exact science.

醫生普遍認為這不是一門精確的科學。

So having an ejection fraction below normal and looking at precise rates is not something that is an exact science, so we're working to make sure that we can bring this product to the largest population possible and where it makes sense.

因此，射血分數低於正常值並查看精確的速率並不是一門精確的科學，因此我們正在努力確保我們可以將這種產品帶到盡可能多的人群中，並且在有意義的地方。

And on AMI, so we'll obviously have to wait for the size -- for the results of the trials.

在 AMI 上，我們顯然必須等待規模——等待試驗的結果。

But our data tells us there are about 7 million AMI events every year across the globe, and 1 in 4 will develop heart failure.

但我們的數據告訴我們，全球每年約有 700 萬次 AMI 事件，四分之一的人會發展為心力衰竭。

So in the U.S. alone, we're talking about 800,000 patients suffering from AMI every year, and these might benefit from Entresto.

因此，僅在美國，每年就有 800,000 名患者患有 AMI，而這些患者可能會從 Entresto 中受益。

So we've got strong access for this product that we've built over the years.

因此，我們對我們多年來打造的這款產品擁有強大的訪問權限。

We've got a great team.

我們有一個很棒的團隊。

And we hope to bring Entresto to a large incremental population if the results of the trial are positive.

如果試驗結果是積極的，我們希望將 Entresto 帶到大量的增量人群中。

Your next question comes from the line of Simon Baker, Redburn.

您的下一個問題來自 Redburn 的 Simon Baker。

Two, if I may, please.

二，如果可以的話，請。

Firstly, on the newer modalities.

首先，關於較新的模式。

On Zolgensma, Vas, you gave us some details at the beginning on the countries you expect to add to reimbursement.

關於 Zolgensma，Vas，您在開始時向我們提供了一些您希望增加報銷的國家/地區的詳細信息。

Could you tell us the current number of countries where Zolgensma is reimbursed?

您能否告訴我們目前 Zolgensma 得到報銷的國家數量？

And on Kymriah, it was a particularly good performance in the fourth quarter against expectations.

而在 Kymriah 上，第四季度的表現特別好，超出了預期。

Could you just give us some color on any pandemic disruption you've seen there and the extent to which that's been offset by the expanding footprint for Kymriah that you discussed?

您能否就您在那裡看到的任何大流行破壞以及您討論的 Kymriah 不斷擴大的足跡在多大程度上抵消了這種影響給我們一些顏色？

And then finally, a quick question on tislelizumab.

最後，關於 tislelizumab 的快速問題。

Could you give us the location of the manufacturer for the trial and commercial material that you will be using?

您能給我們提供您將使用的試驗和商業材料的製造商的位置嗎？

Yes.

是的。

So on -- thanks, Simon.

等等——謝謝，西蒙。

On Zolgensma, outside of the U.S., of course, we have access in Germany through the Standard Access path there.

當然，在美國以外的 Zolgensma，我們可以通過那裡的標準訪問路徑進入德國。

We have reimbursement in Japan.

我們在日本有報銷。

And we're working very -- and we have a limited reimbursement program right now in a few other European countries, particularly Italy -- notably Italy.

我們正在非常努力——我們現在在其他幾個歐洲國家，特別是意大利——特別是意大利，有一個有限的報銷計劃。

What we hope to be able to accomplish in the first half of this year is to establish reimbursement pathways in the U.K., Italy, Spain, Canada and a number of other markets.

我們希望在今年上半年能夠完成的是在英國、意大利、西班牙、加拿大和其他一些市場建立報銷途徑。

We'll see -- those discussions, as I mentioned, have been a little delayed due to the pandemic, but we're hopeful we can accelerate them.

我們會看到——正如我所提到的，這些討論由於大流行而被推遲了一些，但我們希望我們能夠加快它們的進程。

And then on top of that, a key priority for us is to enable access in emerging markets, particularly Turkey, Brazil, but amongst other emerging markets as well, where there is significant SMA populations that could -- children who could benefit from Zolgensma.

最重要的是，我們的一個關鍵優先事項是允許進入新興市場，特別是土耳其、巴西，但也包括其他新興市場，那裡有大量的 SMA 人群——可以從 Zolgensma 中受益的兒童。

So we hope to see a steady pace of getting reimbursement decisions over the coming year.

因此，我們希望在來年能夠穩步做出報銷決定。

Kymriah, Susanne?

凱米莉亞，蘇珊？

Yes.

是的。

Thank you, Simon.

謝謝你，西蒙。

So we were really pleased with the performance of Kymriah also in Q4.

所以我們對 Kymriah 在第四季度的表現感到非常滿意。

Very strong growth.

非常強勁的增長。

And this was really driven by double-digit growth across the geographies, in the U.S., in Europe and Japan, and this despite COVID.

這實際上是由美國、歐洲和日本等地區的兩位數增長推動的，儘管有 COVID。

I would say that the growth is partially driven by the expanding in new markets.

我想說，增長部分是由新市場的擴張推動的。

As I said, there is now 27 markets that have reimbursement for at least one of the Kymriah indications.

正如我所說，現在有 27 個市場對至少一種 Kymriah 適應症進行了報銷。

The increased manufacturing capacity, which means that we could serve all the demand.

增加的製造能力，這意味著我們可以滿足所有需求。

And I have to say you were asking if there is impact from COVID, and yes, there is because some treatments are delayed.

我不得不說你問的是 COVID 是否有影響，是的，這是因為一些治療被推遲了。

But on the other side, I think within the market, Kymriah has performed exceptionally well.

但另一方面，我認為在市場上，Kymriah 的表現非常出色。

We have gained market share.

我們已經獲得了市場份額。

And I think this is probably driven by the strong data that we, also in real-word evidence, could demonstrate that efficacy and also safety is even better than in the JULIET trial.

我認為這可能是由強大的數據驅動的，我們也在真實的證據中證明了療效和安全性甚至比 JULIET 試驗更好。

So I think very, very strong.

所以我認為非常非常強大。

And I think very safe product that would not require ICU space.

而且我認為非常安全的產品不需要 ICU 空間。

And I think this led probably to the decision by many centers to go for Kymriah.

我認為這可能導致許多中心決定選擇 Kymriah。

Yes.

是的。

Thank you, Susanne.

謝謝你，蘇珊。

And then on tislelizumab manufacturing, the product is produced by an established third party -- European-established third party.

然後在 tislelizumab 製造上，產品由成熟的第三方——歐洲成熟的第三方生產。

I'm not sure under our agreements what -- and given the ongoing review, what I can and can't disclose.

我不確定我們的協議是什麼——鑑於正在進行的審查，我可以透露什麼，不可以透露什麼。

I propose we -- our IR team simply gets back to you once we do the appropriate checks.

我建議我們——一旦我們進行了適當的檢查，我們的 IR 團隊就會回复您。

But very reputable, top-class third-party manufacturer from -- based out of Europe.

但是非常有信譽的頂級第三方製造商，來自歐洲以外的地區。

Your next question comes from the line of Kerry Holford from Berenberg.

您的下一個問題來自 Berenberg 的 Kerry Holford。

Yes, Kerry Holford from Berenberg.

是的，來自貝倫貝格的 Kerry Holford。

A couple of questions left for me, please.

請留給我幾個問題。

Firstly, on the BeiGene PD-1.

首先，在百濟神州 PD-1 上。

I wonder if you can just talk through why you took the decision to bring that on board, given you have spartalizumab.

我想知道你是否可以談談為什麼你決定把它帶上飛機，因為你有斯巴達珠單抗。

And what did that asset really offer that yours not?

該資產真正提供了哪些您沒有的資產？

Was it just timing?

只是時機嗎？

Or is there something else here we have to be aware of?

或者這裡還有什麼我們需要注意的嗎？

Should we assume spartalizumab is now -- will you continue those ongoing combinations going to that asset as well?

我們是否應該假設現在是斯巴達珠單抗——您是否還會繼續將這些正在進行的組合用於該資產？

And then secondly, on the branaplam.

其次，在布拉納普拉姆上。

You highlighted in the slide Phase IIb is due to start in Huntington's in the second half of the year.

您在幻燈片中強調的第二階段 b 將於下半年在亨廷頓開始。

I wonder why not any earlier.

我想知道為什麼不早一點。

Is there COVID-related delays?

是否存在與 COVID 相關的延誤？

Is there additional data preparation you need to do in the first half?

上半年你需要做額外的數據準備嗎？

And could that Phase IIb study be seen as a pivotal trial?

IIb 期研究能否被視為一項關鍵試驗？

Yes.

是的。

Thanks, Kerry.

謝謝，克里。

On BeiGene, it does not change the status of our own PD-1 Beovu MS complementary.

在百濟神州，它並沒有改變我們自己的 PD-1 Beovu MS 互補的狀態。

Our own PD-1 was primarily focused, spartalizumab, was focused on a few select indications.

我們自己的 PD-1 主要集中在 spartalizumab 上，主要集中在一些選定的適應症上。

That was the strategy we took with that medicine.

這就是我們對這種藥物採取的策略。

We'll continue on those indications.

我們將繼續研究這些跡象。

BeiGene has taken a very broad development program across the main PD-1 indications without overlap on spartalizumab.

百濟神州在主要的 PD-1 適應症上採取了非常廣泛的開發計劃，沒有與斯巴達珠單抗重疊。

And so we're excited to bring that medicine to market across the full range of indications.

因此，我們很高興將這種藥物推向市場，涵蓋所有適應症。

Susanne, anything you'd want to add on this point?

蘇珊，你想在這一點上補充什麼嗎？

Yes, Vas, just to add, I think that really we were impressed by the very broad development program that BeiGene is running in global programs, having really 15 potentially registration-enabling trials ongoing.

是的，Vas，我想補充一點，我認為百濟神州在全球項目中運行的非常廣泛的開發項目給我們留下了深刻的印象，真正有 15 項潛在的註冊試驗正在進行中。

And I believe, for us, also advantage is that BeiGene has tested tislelizumab in very important indications in monotherapy that's different from spartalizumab, like non-small cell lung cancer, gastric cancer and so on.

而且我相信，對我們來說，另一個優勢是百濟神州已經在與斯巴達珠單抗不同的單一療法中非常重要的適應症中測試了替雷利珠單抗，如非小細胞肺癌、胃癌等。

And therefore, we are excited to bring this product to market ex China.

因此，我們很高興將這款產品推向中國以外的市場。

And then, John, on branaplam time lines for Huntington's.

然後，約翰，關於亨廷頓病的布拉納普蘭時間線。

Yes, branaplam time lines.

是的，branaplam 時間線。

Maybe, Kerry, just one last item on the last question there is we also have a number of targeted therapies that we could use in combination.

也許，克里，關於最後一個問題的最後一項，我們還有許多可以組合使用的靶向療法。

And if we have an approved PD-1, it actually fits very well in terms of a complementary portfolio.

如果我們有一個批准的 PD-1，它實際上非常適合互補的產品組合。

So I think that's something that we thought about given time lines, as you noted in the question.

正如你在問題中提到的，我認為這是我們在給定時間線時考慮的問題。

Specifically on branaplam.

特別是關於branaplam。

As you highlighted, we will get the Phase I results in the first half of this year.

正如您所強調的，我們將在今年上半年獲得第一階段的結果。

With those results, what we intend to do is take it to the health authorities and have discussions.

有了這些結果，我們打算將其提交給衛生當局並進行討論。

And if time lines allow, we certainly will move as quickly as possible.

如果時間允許，我們肯定會盡快行動。

If it's realistic, we will absolutely have Phase IIb in the first half of this year.

如果它是現實的，我們絕對會在今年上半年進行 IIb 期。

But it really depends on the feedback from the health authorities because we will have to have discussions both with the FDA as well as the European agency.

但這真的取決於衛生當局的反饋，因為我們將不得不與 FDA 以及歐洲機構進行討論。

So your last question -- or the last part of that question was, will this allow for a registrational study in Phase IIb?

所以你的最後一個問題——或者這個問題的最後一部分是，這是否允許在 IIb 階段進行註冊研究？

That really will also depend on the discussions that we have as well as the data that we'll see in the Phase I program.

這實際上還取決於我們進行的討論以及我們將在第一階段計劃中看到的數據。

So I think we'll be able to share more with you as we have these discussions and when we see the data.

所以我認為，當我們進行這些討論以及看到數據時，我們將能夠與您分享更多信息。

Your next question comes from the line of Peter Welford from Jefferies.

您的下一個問題來自 Jefferies 的 Peter Welford。

Firstly, just going to another pipeline asset, iscalimab.

首先，只是去另一個管道資產，iscalimab。

Wonder if you could just give us a bit of clarity on the path forward for filing of that now.

想知道您是否可以讓我們清楚地說明現在提交該文件的路徑。

I see your commentary that the regulatory interactions suggest that you can't file, you don't think, based on kidney transplant -- sorry, based on the ongoing study.

我看到你的評論，監管互動表明你不能提交，你不認為，基於腎移植——對不起，基於正在進行的研究。

And so what is the planned time line there?

那麼那裡的計劃時間表是什麼？

Can you use liver and kidney together?

肝腎可以一起用嗎？

Or has another trial started or planned to be started?

或者是否已經開始或計劃開始另一項試驗？

And how do you think about that?

你怎麼看？

And what sort of endpoints are the regulators requiring?

監管機構需要什麼樣的端點？

And then secondly, just on the generics, obviously, guiding towards no Sandostatin and Gilenya generics during the course of this year from Harry.

其次，就彷製藥而言，顯然，Harry 在今年的課程中沒有使用 Sandostatin 和 Gilenya 仿製藥。

I guess makes sense on Gilenya.

我想對 Gilenya 來說是有道理的。

I presume we're still going to wait for clarity from the court before you give us timing on that one.

我想在你給我們時間之前，我們仍然要等待法庭的澄清。

For Sandostatin in the U.S. Can you just give us some clarity on, I guess, what sort of research or visibility you have on that?

對於美國的 Sandostatin，您能否讓我們澄清一下，我猜，您對此有什麼樣的研究或知名度？

And sort of your confidence that we won't see a U.S. Sandostatin LAR generic this year?

你有信心今年我們不會看到美國的 Sandostatin LAR 仿製藥嗎？

So great.

很好。

John, on iscalimab?

約翰，在伊斯卡利單抗上嗎？

Yes.

是的。

Thanks, Peter.

謝謝，彼得。

On iscalimab, this is our anti-CD40, as you know.

如您所知，在 iscalimab 上，這是我們的抗 CD40。

We had intentions of moving forward, and we still have intentions of moving forward, with 2 or 3 indications: Renal transplant, liver transplant as well as Sjogren's.

我們有前進的意圖，我們仍然有前進的意圖，有 2 或 3 個適應症：腎移植、肝移植以及 Sjogren 的。

We took an aggressive clinical strategy, given that there's really been no improvement or change of standard of care for renal transplant in 35 years other than calcineurin inhibitors.

我們採取了積極的臨床策略，因為除了鈣調神經磷酸酶抑製劑之外，35 年來腎移植的護理標準確實沒有任何改善或變化。

I think we noted previously in discussions, whether that was Meet Novartis Management or other calls, where we were using a digital endpoint.

我想我們之前在討論中提到過，無論是與諾華管理層見面還是其他電話，我們都在使用數字端點。

And we were having really good discussions with the agency on using this aggressive approach using this digital end point.

我們與該機構進行了非常好的討論，以使用這個數字端點使用這種激進的方法。

At the end of the year last year, they came back and they noted that they wanted to still use the same endpoint as previously, which is the part -- biopsy-proven acute rejection.

去年年底，他們回來了，他們指出他們仍想使用與以前相同的終點，這就是活檢證實的急性排斥反應的一部分。

Having that as feedback, we felt like we wanted to ensure that we have a path forward, which would be a full Phase III, so -- which would be the same time lines as developing your traditional transplant drugs.

有了這些反饋，我們覺得我們想確保我們有一條前進的道路，這將是一個完整的第三階段，所以 - 這將與開發傳統移植藥物的時間線相同。

Noting that, we do feel like there's also a potentially faster path through Sjogren's, and we're awaiting the Sjogren's Phase IIb result.

注意到這一點，我們確實覺得還有一條可能更快通過 Sjogren 的途徑，我們正在等待 Sjogren 的 IIb 期結果。

And once we have those results, we'll be able to disclose the overall time lines on the Sjogren's program, which may be faster than the transplant program.

一旦我們得到這些結果，我們將能夠披露 Sjogren 計劃的總體時間線，這可能比移植計劃更快。

Thanks, John.

謝謝，約翰。

On Sandostatin LAR generics in the U.S., Susanne?

關於美國的 Sandostatin LAR 仿製藥，Susanne？

Yes, Peter.

是的，彼得。

I mean, as you know, there is 1 generic company that has achieved marketing authorization in Europe and is doing a very targeted commercialization, currently being really commercialized only in 8 markets, including Germany, France and U.K...

我的意思是，如你所知，有1家仿製藥公司已經在歐洲獲得了上市許可，並且正在做一個非常有針對性的商業化，目前真正商業化的只有8個市場，包括德國、法國和英國……

Our guidance for the U.S. is based on the fact that this same company has application running in the U.S. since a while.

我們對美國的指導基於這樣一個事實，即同一家公司一段時間以來一直在美國運行應用程序。

We have no update at this point.

我們目前沒有更新。

But given also the situation with COVID, we expect that this process could take longer.

但也考慮到 COVID 的情況，我們預計此過程可能需要更長的時間。

But there is no concrete update and there is no new information.

但是沒有具體的更新，也沒有新的信息。

Thanks, Susanne.

謝謝，蘇珊。

Just a quick note for Simon from Redburn.

給 Redburn 的 Simon 做個簡短的說明。

We did a quick check, and I can confirm that the tislelizumab is produced at the Boehringer-Ingleheim production site in Shanghai.

我們進行了快速檢查，我可以確認替雷利珠單抗是在上海的勃林格殷格翰生產基地生產的。

Your next question comes from the line of Keyur Parekh from Goldman Sachs.

您的下一個問題來自高盛的 Keyur Parekh。

And first of all, Vas, congratulations on the progress you've made on the ESG front, especially with the Access of Medicine, going up #2.

首先，Vas，祝賀您在 ESG 方面取得的進展，尤其是在獲取藥物方面，上升了 #2。

Now kind of 2 questions for me, broad picture, please.

現在對我有 2 個問題，請提供廣泛的圖片。

First, kind of your slide on the BG collaboration suggests that you are open to a broader strategic collaboration with BG.

首先，您關於 BG 合作的幻燈片表明您對與 BG 進行更廣泛的戰略合作持開放態度。

Maybe I'm overinterpreting that sentence, but would love to hear kind of what you are envisaging there.

也許我過度解釋了這句話，但很想听聽你在那裡的設想。

Is this kind of a corporate collaboration?

這是一種企業合作嗎？

Is it a collaboration from an oncology perspective?

從腫瘤學的角度來看，這是一次合作嗎？

Is this for Novartis to sell stuff into China?

這是諾華向中國賣東西嗎？

Why have them -- for you to import innovation?

為什麼要有它們——讓您導入創新？

Just anything you can add to that would be great.

您可以添加的任何內容都會很棒。

And then secondly, as you look at kind of the bigger-picture growth that you are suggesting you are comfortable with consensus through to 2025, which is a 4% top line growth.

其次，當你看到大局的增長時，你暗示你對到 2025 年的共識感到滿意，這是 4% 的收入增長。

To my mathematics, consensus has a 7%, 8% EPS growth.

根據我的數學，共識有 7%、8% 的每股收益增長。

If you aren't successful at delivering that, that would put you in the middle of or in line with your peer group.

如果你不能成功地做到這一點，那會讓你處於同齡人的中間或與你的同齡人一致。

Surely, your ambitions are bigger and higher than that.

當然，你的野心比這更大更高。

So I was wondering if you might tell us what your kind of ambitions are and where you think you might actually get to.

所以我想知道你是否可以告訴我們你的抱負是什麼，以及你認為你可能會真正到達哪裡。

Yes.

是的。

Thanks, Keyur, and thanks for the comments as well on ESG.

謝謝 Keyur，也感謝您對 ESG 的評論。

We're very pleased with the collaboration with BeiGene in China.

我們對與百濟神州在中國的合作感到非常高興。

And I think it fits with our broader goal to double the size of our Chinese business.

我認為這符合我們將中國業務規模擴大一倍的更廣泛目標。

As I noted, we were one of the fastest-growing multinationals.

正如我所指出的，我們是增長最快的跨國公司之一。

I noted all the NRDL listings and the upcoming approvals.

我注意到所有 NRDL 列表和即將獲得的批准。

We're continuing to explore partnership discussions with a number of local Chinese players.

我們正在繼續探索與一些中國本土玩家的合作討論。

I think, specifically, BeiGene, of course, has a broader portfolio, has a strong oncology presence in China.

我認為，具體來說，百濟神州當然擁有更廣泛的產品組合，在中國擁有強大的腫瘤學業務。

And of course, we're looking forward to continuing that strong collaboration with them, but also with other strong local Chinese players as it makes sense for our portfolio.

當然，我們期待繼續與他們以及其他強大的中國本土企業繼續開展強有力的合作，因為這對我們的產品組合很有意義。

So no specific plans or decisions, but I think more just to highlight that our ambitions in China are significant, and we think we're on the right track with very strong teams across GDD and John's organization as well as Marie-France and Susanne's commercial teams.

所以沒有具體的計劃或決定，但我認為更多只是為了強調我們在中國的雄心壯志，我們認為我們正走在正確的軌道上，GDD 和 John 的組織以及 Marie-France 和 Susanne 的商業團隊都非常強大團隊。

In terms of the mid- to long-term ambitions, I think nothing more to add.

至於中長期的野心，我覺得沒什麼可補充的。

Of course, as a CEO who wants our company to lead and be the leading medicines company in the industry, have very high ambitions.

當然，作為一個希望我們公司成為行業領先的醫藥公司的CEO，有著非常高的抱負。

But I think more appropriate me for me to keep those ambitions to myself and continue to simply say we're comfortable, as we've said, stated with our sales and margin outlook from the consensus out to 2025.

但我認為更適合我把這些抱負留給自己，並繼續簡單地說我們很舒服，正如我們所說，我們對從共識到 2025 年的銷售和利潤率前景表示滿意。

And we'll do our best to deliver a world-class pipeline portfolio and execution across all 5 of our strategic priorities to get that.

我們將盡最大努力在我們所有 5 個戰略優先事項中提供世界一流的管道組合和執行，以實現這一目標。

And then most important, in my mind, is to continue a strong growth trajectory beyond 2025 as well because we of course play this for the very long game.

在我看來，最重要的是在 2025 年之後繼續保持強勁的增長軌跡，因為我們當然會在很長一段時間內玩這個遊戲。

Your next question comes from the line of Andrew Baum from Citi.

您的下一個問題來自花旗銀行的 Andrew Baum。

[Emily Hutchinson] from Citi on behalf of Andrew Baum.

[Emily Hutchinson] 來自花旗，代表 Andrew Baum。

Just 1 question, please.

請只問1個問題。

On Cosentyx, can you talk to the anticipated performance in the U.S. in 2021, given, I note, exclusion from a couple of national formularies?

在 Cosentyx 上，您能否談談 2021 年美國的預期表現，我注意到，被排除在幾個國家處方集之外？

Thank you, Emily.

謝謝你，艾米麗。

This is the longest I've ever gone in an IR call in this role without a Cosentyx question.

這是我在沒有 Cosentyx 問題的情況下擔任這個角色的 IR 電話中最長的一次。

So Marie-France, on Cosentyx.

所以 Marie-France，在 Cosentyx 上。

Yes, I'm very happy to get at least one question on Cosentyx.

是的，我很高興至少有一個關於 Cosentyx 的問題。

So the first thing I'd say is I think we need to put this in perspective because our overall access position in the U.S. remains incredibly strong.

所以我要說的第一件事是，我認為我們需要正確看待這一點，因為我們在美國的整體訪問地位仍然非常強大。

In fact, you heard me say that before, early line access is a key pillar to our strategy.

事實上，你之前聽我說過，早期線路接入是我們戰略的關鍵支柱。

However, we're always going to balance access with long-term sustainability for Cosentyx, and you can expect us to continue to do that.

但是，我們始終會在 Cosentyx 的訪問與長期可持續性之間取得平衡，您可以期待我們繼續這樣做。

Now specifically on the ESI decision, which is what you're referring to.

現在特別是關於 ESI 決定，這就是你所指的。

You can obviously expect to see some impact on volume from this account, and that will also be reflected in our NBRx share.

您顯然可以期望看到此帳戶對交易量的一些影響，這也將反映在我們的 NBRx 份額中。

But know that we're confident in our ability to grow Cosentyx based on our 3 strategic pillars.

但要知道，我們對基於我們的 3 個戰略支柱發展 Cosentyx 的能力充滿信心。

We talked about access.

我們談到了訪問。

We talked about the competitive product profile across 4 indications.

我們討論了 4 個適應症的競爭產品概況。

And then very importantly, our life cycle management opportunities that could bring up to 6 indications in the future.

然後非常重要的是，我們的生命週期管理機會在未來可能帶來多達 6 個跡象。

So we've consistently delivered double-digit growth despite the competition and despite the fact that there is a lot going on in this market, and you'll see us do that again in 2021.

因此，儘管競爭激烈，儘管這個市場發生了很多事情，但我們始終實現了兩位數的增長，您將在 2021 年看到我們再次做到這一點。

These access decisions are short-term decisions.

這些訪問決策是短期決策。

It's not going to change the long-term trajectory for Cosentyx or our ability to reach $5 billion and beyond.

這不會改變 Cosentyx 的長期發展軌跡，也不會改變我們達到 50 億美元及以上的能力。

(Operator Instructions)

（操作員說明）

Your next question comes from the line of Seamus Fernandez from Guggenheim.

您的下一個問題來自古根海姆的 Seamus Fernandez。

So really just wanted to get an update on iscalimab in Sjogren's disease.

所以真的只是想了解一下iscalimab在乾燥症中的最新情況。

I think previously, you had stated that you were planning for either an interim towards the end of this year or perhaps even a final look at those data.

我認為之前，您曾表示您計劃在今年年底之前進行臨時性的研究，或者甚至可能最終查看這些數據。

So just wanted to get an update on iscalimab in Sjogren's disease.

所以只是想了解一下iscalimab在乾燥症中的最新情況。

And maybe if you could just give us a little color on the ability to recruit patients or continue recruiting patients into that study.

也許你能給我們一點關於招募患者或繼續招募患者參與該研究的能力。

If recruitment is completed, then obviously, that question is irrelevant.

如果招聘完成，那麼顯然，這個問題是無關緊要的。

John, on iscalimab?

約翰，在伊斯卡利單抗上嗎？

Yes.

是的。

On iscalimab, thanks for the question, Seamus.

關於 iscalimab，感謝 Seamus 的提問。

As Vas disclosed earlier, we're really not disclosing the interims moving forward.

正如 Vas 早些時候披露的那樣，我們實際上並沒有披露未來的過渡期。

So as we're moving forward, the recruitment has been a little bit slower than we anticipated.

因此，隨著我們前進，招聘速度比我們預期的要慢一些。

We're not fully recruited in the Phase IIb for iscalimab yet.

我們尚未完全招募 iscalimab 的 IIb 期。

So the recruitment continues, and those time lines really will depend on when we finish recruitment.

所以招聘仍在繼續，而這些時間線實際上將取決於我們何時完成招聘。

So we'll provide further updates in terms of the exact timing of completion of that trial.

因此，我們將在完成該試驗的確切時間方面提供進一步的更新。

Your next question comes from the line of Richard Vosser from JPMorgan.

您的下一個問題來自摩根大通的 Richard Vosser。

Question on Zolgensma and the intrathecal form.

關於 Zolgensma 和鞘內形式的問題。

Just could you give us some help on the design of the pivotal trial?

您能否就關鍵試驗的設計給我們一些幫助？

Would you look to broaden the age range beyond the 2 to 5 years, which was the original, I suppose, STRONG trial design?

您是否希望將年齡範圍擴大到 2 到 5 歲之外，我想這是最初的 STRONG 試驗設計？

And given your -- the thoughts on what's happened to other gene therapies, what do you think the regulators would need in terms of duration, durability to see, particularly in, I suppose, type 2 SMA patients?

考慮到您對其他基因療法發生了什麼的想法，您認為監管機構在持續時間、持久性方面需要什麼，尤其是在我想的 2 型 SMA 患者中？

Yes.

是的。

Thank, Richard.

謝謝，理查德。

So we're in discussions now with FDA on finalizing that clinical trial design.

所以我們現在正在與 FDA 討論最終確定臨床試驗設計。

I think the discussions are very positive both on dose and duration, but we haven't finalized the design.

我認為關於劑量和持續時間的討論都非常積極，但我們還沒有最終確定設計。

Hopefully, by Q1, we'll be able to give you at least a perspective on what the agreed design of the study is, assuming we get off clinical hold later on in the year.

希望到第一季度，假設我們在今年晚些時候停止臨床擱置，我們至少能夠讓您了解商定的研究設計是什麼。

So still more to come, and we'll keep you posted.

所以還有更多，我們會及時通知你。

Your next question comes from the line of Florent Cespedes from Societe Generale.

您的下一個問題來自法國興業銀行的 Florent Cespedes。

A quick one for Richard on Sandoz.

在 Sandoz 上為 Richard 提供的快速解決方案。

Could you please share with us, how do you see the dynamic of the non-biosimilar business?

您能否與我們分享一下，您如何看待非生物仿製藥業務的動態？

Because we see understand how -- what is driving this business.

因為我們看到了解如何 - 是什麼推動了這項業務。

But for the rest of the portfolio, it's a bit more difficult to understand.

但對於投資組合的其餘部分，它有點難以理解。

Could you maybe elaborate on this, on the midterm dynamic of the non-biosimilar business?

您能否詳細說明一下非生物仿製藥業務的中期動態？

Richard?

理查德?

See if we still have Richard.

看看我們是否還有理查德。

Richard, are you on the line?

理查德，你在線嗎？

Well, has he...

嗯，他有沒有...

Richard's line is still -- sorry, sir.

理查德的電話仍然是——對不起，先生。

Richard's line is still connected.

理查德的線路仍然連接。

Okay.

好的。

Well, I'll just quickly answer the question.

好吧，我會快速回答這個問題。

I think the dynamics we see right now, biosimilars primarily growth in Europe and Japan.

我認為我們現在看到的動態，生物仿製藥主要在歐洲和日本增長。

In the U.S., it continues to be a mixed picture.

在美國，情況仍然是喜憂參半。

Of course, hopeful that in our next wave of assets, we can get a much broader set of assets launched in the U.S., with 15 projects now progressing through our biosimilars portfolio.

當然，希望在我們的下一波資產中，我們可以在美國推出更廣泛的資產，目前有 15 個項目正在通過我們的生物仿製藥組合進行。

In terms of small molecules, the softness we saw was primarily in anti-infectives in Europe as well as the legacy or the oral solids business we brought back from Aurobindo.

在小分子方面，我們看到的柔軟主要是在歐洲的抗感染藥以及我們從 Aurobindo 帶回的傳統或口服固體業務。

What we're hopeful now is that hopefully we see demand start to pick up again over the course of this year, but much more important is revitalizing our pipeline and revitalizing our first-to-file engine in the U.S. and being at market formation in Europe.

我們現在希望的是，我們希望在今年的過程中看到需求再次開始回升，但更重要的是重振我們的管道，重振我們在美國的首次申請引擎，並處於市場形成階段歐洲。

We think the combination of those 2 pillars, the biosimilars pipeline and the first-to-file pipeline, should get us to that mid-single-digit growth rate over time.

我們認為，生物仿製藥管道和首次申請管道這兩個支柱的結合，應該會讓我們隨著時間的推移達到中個位數的增長率。

Your next question comes from the line of Naresh Chouhan from Intron.

您的下一個問題來自 Intron 的 Naresh Chouhan。

Just 1 on M&A, please.

請只談一談併購。

You've had a couple of large deals which have resulted in some issues where we argue that, if those assets were developed internally, the likelihood of those problems arising would have been probably much less likely to have occurred.

您已經進行了幾筆大型交易，這些交易導致了一些問題，我們認為，如果這些資產是內部開發的，那麼出現這些問題的可能性可能會大大降低。

I'm thinking the AveXis data integrity issues, the Leqvio CDMO issues.

我在想 AveXis 數據完整性問題，Leqvio CDMO 問題。

And given that even the most diligent of acquirers would have been probably unlucky to have found those issues, does it dim your enthusiasm for future deals of this size given the risks involved?

鑑於即使是最勤奮的收購者也可能不幸發現這些問題，考慮到所涉及的風險，這是否會降低您對未來此類規模交易的熱情？

And if I may, just -- does the $60 billion sales number include M&A?

如果可以的話，600 億美元的銷售額是否包括併購？

Or is that just organic growth?

或者這只是有機增長？

Yes.

是的。

Thanks, Naresh.

謝謝，納雷什。

On the second part, just organic growth.

第二部分，只是有機增長。

We're not including M&A.

我們不包括併購。

I think less about -- I mean, look, I think when we go into new technology areas, which we believe we need to do in the long run to be a leader, to be competitive to drive growth, we are going to learn new things.

我想的少——我的意思是，看，我認為當我們進入新技術領域時，我們認為從長遠來看，我們需要這樣做才能成為領導者，具有競爭力以推動增長，我們將學習新的知識事物。

I think, certainly, the fact that we are doing small interfering RNA and novel gene therapies is part of the reason we have some of the challenges that we do.

我認為，當然，我們正在進行小干擾 RNA 和新型基因療法這一事實是我們面臨一些挑戰的部分原因。

But I would say it's less about that and more we have enough on our plate with a full internal pipeline.

但我會說這不是那麼重要，我們有更多的事情要做，有一個完整的內部管道。

We've done a number of deals which we're currently working on fully scaling.

我們已經完成了許多交易，我們目前正在努力全面擴展。

We have 4 platforms we want to get to global leadership on.

我們有 4 個平台希望在其上獲得全球領導地位。

So we have plenty to do.

所以我們有很多事情要做。

Always opportunistically thinking about M&A, but that's not in focus at the moment.

總是投機取巧地考慮併購，但這不是目前的重點。

We want to execute on the strategy and plan we have ahead of us.

我們希望執行擺在我們面前的戰略和計劃。

And that's what we're focused on at the moment.

這就是我們目前關注的重點。

Your next question comes from the line of Emily Field from Barclays.

您的下一個問題來自巴克萊銀行的 Emily Field。

I just had a quick question on 2021 and the impact of taking on tislelizumab.

我剛問了一個關於 2021 年的問題以及服用替雷利珠單抗的影響。

I was just wondering if you could give us a sense of the order of magnitude of the incremental development costs that you'll be taking on with this asset.

我只是想知道您是否可以讓我們了解您將使用此資產承擔的增量開發成本的數量級。

And is that mostly coming from R&D and the initiation of these combination trials?

這主要來自研發和這些組合試驗的啟動嗎？

Yes, Harry, you want to provide some color on that or clarity on that?

是的，Harry，你想提供一些顏色或清晰度嗎？

Yes, thank you.

是的，謝謝。

So it's a bit complicated.

所以有點複雜。

But first of all, we do account for the appropriate, if you will, share of development costs of the current registration trials in our core P&L.

但首先，如果您願意，我們確實會在我們的核心損益表中考慮當前註冊試驗的開發成本份額。

It's about 1 point of core operating income growth, if you will, from a dilution standpoint.

如果你願意的話，從稀釋的角度來看，這大約是核心營業收入增長的 1 個百分點。

But it will not be a cash expense because the current portfolio is being executed by BeiGene and is part of our upfront payment.

但這不會是現金支出，因為目前的投資組合由百濟神州執行，並且是我們預付款的一部分。

So it's not a cash expense, but an expense.

所以這不是現金支出，而是支出。

Given the structure of the deal, we always want to ensure that our core results and the core accounting is of the highest quality as well.

鑑於交易的結構，我們始終希望確保我們的核心結果和核心會計也具有最高質量。

Last question, operator?

最後一個問題，接線員？

Your last question today comes from the line of Mark Purcell from Morgan Stanley.

您今天的最後一個問題來自摩根士丹利的 Mark Purcell。

Vas, it's just another clarification investor question actually on tislelizumab.

Vas，這實際上是關於 tislelizumab 的另一個澄清投資者問題。

The question was, the 15 registration trials that Susanne mentioned, I'm being asked which of those -- which regions and which indications are you going to be able to file?

問題是，Susanne 提到的 15 項註冊試驗，有人問我其中哪些——您將能夠提交哪些地區和哪些適應症？

So I guess the question is really reflecting if you need any additional data in a specific country such as the U.S. or parts of Europe in any specific indications.

因此，我想這個問題確實反映了您是否需要在特定國家（例如美國或歐洲部分地區）的任何特定跡像中的任何其他數據。

Yes.

是的。

Thanks, Mark.

謝謝，馬克。

So I'll just quickly take it.

所以我會很快接受它。

We have rights in U.S., Europe and a number of other ex U.S. markets.

我們在美國、歐洲和許多其他美國以外的市場擁有權利。

BeiGene keeps rights in parts of Asia and Latin America.

百濟神州保留在亞洲和拉丁美洲部分地區的權利。

The clinical trial portfolio -- clinical trials currently being conducted are already conducted with support filings in a full range of indications.

臨床試驗組合——目前正在進行的臨床試驗已經在各種適應症的支持文件中進行。

So second line in lung which they hope to complete this year, first-line lung, colorectal cancer, head and neck.

所以他們希望今年完成的肺二線，一線肺，大腸癌，頭頸部。

Susanne, are there others that I'm missing?

蘇珊，還有其他我想念的嗎？

No, I think gastric is also there.

不，我認為胃也在那裡。

Yes, head and neck, you mentioned.

是的，你提到的頭和脖子。

And I mean, these are global programs, that's probably worth to mention.

我的意思是，這些都是全球計劃，這可能值得一提。

They're enrolling not only Chinese patients, but also from other geographies.

他們不僅招募中國患者，還招募其他地區的患者。

And I think what is important in this setting, that the comparator is strong.

而且我認為在這種情況下重要的是，比較器很強大。

And for example, we are excited about the second-line data in non-small cell number.

例如，我們對非小細胞數的二線數據感到興奮。

BeiGene reported very strong over survival data versus doxo.

與 doxo 相比，百濟神州報告了非常強的生存數據。

So I think that's how you have to see this, that the clinical program, we believe, is very robust and would allow for filings ex U.S. -- sorry, ex China.

所以我認為這就是你必須看到的，我們認為臨床項目非常強大，並且允許在美國以外的地方提交申請——對不起，在中國以外的地方。

Thanks, everyone, for joining today's call.

謝謝大家加入今天的電話會議。

We appreciate it, appreciate your interest in our company.

我們很感激，感謝您對我們公司的興趣。

As well as to all the investors, appreciate your support of Novartis.

以及所有投資者，感謝您對諾華的支持。

And we'll look forward to keeping you up to speed over the course of this year.

我們期待在今年讓您跟上進度。

Please stay healthy, and thank you again.

請保持健康，再次感謝您。

Thank you.

謝謝你。

That does conclude our conference for today.

這確實結束了我們今天的會議。

Thank you for participating.

感謝您的參與。

You may all disconnect.

你們都可以斷開連接。