Novartis AG (NVS) 2021 Q3 法說會逐字稿

Good morning and good afternoon, and welcome to the Novartis Q3 2021 Results Release Conference Call and Live Webcast. (Operator Instructions) And the conference is being recorded. (Operator Instructions)

早上好，下午好，歡迎來到諾華 2021 年第三季度業績電話會議和網絡直播。 （操作員說明）會議正在錄製中。 （操作員說明）

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

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。 （操作員說明）

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

至此，我想向投資者關係全球主管 Samir Shah 先生匯報。請繼續，先生。

Thank you very much, and hello, everybody. I'd like to thank you for taking the time to participate in the Q3 Novartis Conference Call.

非常感謝，大家好。感謝您抽出寶貴時間參加第三季度諾華電話會議。

The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. For a description of some of these factors, please refer to the company's Form 20-F, its most recent quarterly results on Form 6-K that respectively were filed with and furnished to the U.S. Securities and Exchange Commission.

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。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。有關其中一些因素的描述，請參閱公司的 20-F 表格，該公司在表格 6-K 上的最新季度業績分別提交給美國證券交易委員會並提供給美國證券交易委員會。

And with that, I'll hand the call to Vas.

有了這個，我會把電話交給 Vas。

Thank you, Samir, and thank you for everyone for joining today's conference call. With me in the room, if I could have the slide up with our colleagues, on Slide 3, with me in the room, I have Harry; Marie-France; Susanne; John; Richard; Karen; and, of course, Samir, who you've just heard from.

謝謝你，薩米爾，謝謝大家參加今天的電話會議。我在房間裡，如果我能和我們的同事一起上幻燈片，在幻燈片 3 上，我在房間裡，我有 Harry；瑪麗-法蘭西；蘇珊；約翰;理查德;凱倫；當然，還有你剛剛聽到的薩米爾。

So turning to Slide 4 and then Slide 5. We wanted to start by taking a step back and really reflecting on how this quarter continues, I think, what has been a very strong trend for the company over the past 4 years. Looking at 9 months, for each of the years back to 2018, you see we've consistently demonstrated the ability to grow our sales at 6%, annual CAGR 13% on core operating income and a consistent expansion of our innovative medicines margins.

所以轉向幻燈片 4，然後是幻燈片 5。我們想先退後一步，真正反思本季度如何繼續，我認為，過去 4 年公司的一個非常強勁的趨勢。回顧 9 個月，對於自 2018 年的每一年，您會看到我們始終證明我們有能力以 6% 的速度增長我們的銷售額，核心營業收入的年復合年增長率為 13%，並且我們的創新藥物利潤率持續擴大。

Now looking ahead, we stand behind our belief that we can continue to grow our sales over the coming period at a CAGR of 4%, driven by, first and foremost, our key growth drivers, which we'll talk more about over the course of this call; our strong mid-stage pipeline; and the continued investment we have on technology platforms, which we think over time will differentiate us and enable us to have a steady flow of innovations to drive growth.

現在展望未來，我們堅信我們可以在未來一段時間內以 4% 的複合年增長率繼續增長我們的銷售額，這首先是由我們的主要增長驅動因素驅動的，我們將在課程中詳細討論這個電話；我們強大的中期管道；以及我們對技術平台的持續投資，我們認為隨著時間的推移，這將使我們與眾不同，並使我們能夠擁有源源不斷的創新來推動增長。

Moving to Slide 6. For Q3, we had strong performance across each of our 4 main value drivers. We'll talk about sales growth throughout the call, and Harry and our colleagues, Marie-France and Susanne, will give you more details. We had good productivity with our core operating margin now reaching 37.8% in IM.

轉到幻燈片 6。對於第三季度，我們在 4 個主要價值驅動因素中的每一個都表現出色。我們將在整個電話會議中討論銷售增長，Harry 和我們的同事 Marie-France 和 Susanne 將為您提供更多詳細信息。我們的生產力很好，我們的核心營業利潤率現在在 IM 中達到 37.8%。

On the innovation front, I'll go through some of the milestones in more detail later on. But I think it was a busy quarter for us with some negatives, but more positive overall on balance. And we continue our journey on the innovation -- on our innovation efforts. And then lastly, in ESG, we had our recent ESG Day where we laid out our longer-term ESG strategy. And we continue to have the ambition to not only lead in the biopharmaceutical industry, but also across large companies.

在創新方面，稍後我將更詳細地介紹一些里程碑。但我認為這對我們來說是一個忙碌的季度，有一些負面因素，但總體而言更積極。我們繼續我們的創新之旅——我們的創新努力。最後，在 ESG 方面，我們舉辦了最近的 ESG 日，我們制定了長期 ESG 戰略。我們繼續有雄心，不僅要引領生物製藥行業，還要跨越大公司。

Now moving to Slide 7. Our key growth drivers and launches had a good momentum in quarter 3. We're very pleased with the performance. We'll go through some of the brands over the course of the call. But notably, we now have 53% of our sales in the quarter coming from these key growth brands, and that's up 26% versus prior year. And I think that demonstrates that we're a company that has replacement power, that can continue to generate innovations that overcome expiries and drive that consistent growth over time.

現在轉到幻燈片 7。我們的主要增長動力和發佈在第三季度勢頭良好。我們對業績感到非常滿意。在通話過程中，我們將介紹一些品牌。但值得注意的是，我們本季度 53% 的銷售額來自這些關鍵增長品牌，與去年同期相比增長了 26%。我認為這表明我們是一家擁有替代能力的公司，可以繼續產生創新，克服到期，並隨著時間的推移推動持續增長。

Moving to Slide 8. We had particularly strong growth on some of our key brands, including Cosentyx, growing 18%, Entresto was up 41%, Zolgensma up 49%, Kisqali 27%, and Cosentyx continues on its solid and accelerating launch trajectory. Marie-France will go through that in a bit more detail.

轉到幻燈片 8。我們的一些主要品牌的增長特別強勁，包括 Cosentyx，增長 18%，Entresto 增長 41%，Zolgensma 增長 49%，Kisqali 27%，Cosentyx 繼續其穩健且加速的發布軌跡。 Marie-France 將更詳細地介紹這一點。

Moving to Slide 9. We announced this morning, we are raising our peak sales guidance for both Cosentyx and Entresto. So first, from Cosentyx, and we'll go through this in more detail a bit later. We've raised our peak sales guidance to $7 billion. This is driven by market growth, geographic expansion as well as life-cycle management opportunities. And we expect this brand to continue to be a strong element of Novartis' story through this entire decade.

轉到幻燈片 9。我們今天早上宣布，我們將提高 Cosentyx 和 Entresto 的峰值銷售指導。首先，來自 Cosentyx，稍後我們將更詳細地介紹這一點。我們已將最高銷售指導提高至 70 億美元。這是由市場增長、地域擴張以及生命週期管理機會推動的。我們預計這個品牌將在整個十年中繼續成為諾華故事的重要元素。

Now moving to Entresto. We believe on slide -- back on Slide 9, we believe we'll continue to have strong growth driven by market penetration, guidelines and geographic expansion. Our peak sales guidance is consistent with our currently stated assumption of an LOE in 2025. However, we do have issued patents going out to 2027 and an additional group of patents that were recently issued out to 2033. And we'll continue to aggressively defend our IP to maximize the impact of this medicine.

現在搬到Entresto。我們相信幻燈片——回到幻燈片 9，我們相信我們將繼續在市場滲透、指導方針和地域擴張的推動下實現強勁增長。我們的峰值銷售指導與我們目前聲明的 2025 年 LOE 假設是一致的。但是，我們確實已經發布了到 2027 年的專利，以及最近發佈到 2033 年的另一組專利。我們將繼續積極捍衛我們的 IP 以最大限度地發揮這種藥物的影響。

Now moving to the next slide. I also wanted to say a word on China, where we continue our strong growth trajectory, one of the leading multinationals in the market in China. We continue with a double-digit growth in the high teens, 16% and 18% on the quarter. This is driven by a few factors. One, the continued positive momentum we have on our growth drivers that have NRDL inclusion. And we believe we're outperforming other multinational companies for the sales growth of these NRDL-listed brands. We also have limited exposure to value -- to the volume-based pricing.

現在轉到下一張幻燈片。我還想談一談中國，我們在中國繼續強勁增長，是中國市場領先的跨國公司之一。我們繼續在本季度保持兩位數的增長，分別為 16% 和 18%。這是由幾個因素驅動的。第一，我們在納入 NRDL 的增長動力方面持續保持積極勢頭。我們相信我們在這些國家醫保目錄上市品牌的銷售增長方面表現優於其他跨國公司。我們對價值的敞口也有限——基於數量的定價。

When you look at our commercial footprint, we've been expanding our commercial footprint to reach lower-tier cities and hospitals. And lastly, our late-stage pipeline continues to mature in China. We had some important recent approvals, Entresto hypertension and Lucentis and additional indications. And we have 50 additional submissions planned in the next 5 years. So we're confident we're on track to double our China sales from the 2020 base by 2024.

當您查看我們的商業足跡時，我們一直在將我們的商業足跡擴展到低線城市和醫院。最後，我們的後期管道在中國繼續成熟。我們最近獲得了一些重要的批准，Entresto 高血壓和 Lucentis 以及其他適應症。我們計劃在未來 5 年內再提交 50 份申請。因此，我們有信心，到 2024 年，我們的中國銷售額將在 2020 年的基礎上翻一番。

Moving to the next slide. Now turning to Sandoz. In Sandoz, we had a mixed quarter. We see in the ex-U.S. dynamics normalizing, but a little more challenging environment in the U.S. So first, in Europe, we had a 2% sales growth. And this was really driven by both biosimilars as well as retail and a return to gaining market share in our key markets.

轉到下一張幻燈片。現在轉向山德士。在 Sandoz，我們有一個喜憂參半的季度。我們在前美國看到動態正常化，但美國的環境更具挑戰性所以首先，在歐洲，我們的銷售額增長了 2%。這實際上是由生物仿製藥和零售以及在我們的主要市場中重新獲得市場份額所推動的。

In the Rest of World region, we were up 6% with steady growth across regions. However, in the U.S., we did see a 20% decline. And this was driven by price erosion as well as contract terminations in our oral solids business. We also had an impact on core operating income. This is primarily driven by the unfavorable gross margins from the product mix in the U.S.

在世界其他地區，我們增長了 6%，各地區均保持穩定增長。然而，在美國，我們確實看到了 20% 的下降。這是由價格侵蝕以及我們的口服固體業務合同終止所驅動的。我們還對核心營業收入產生了影響。這主要是由於美國產品組合的不利毛利率所致。

Now turning to Q4. We do expect performance to normalize in the ex-U.S., and we'll continue to work to stabilize the U.S. We expect our direct demand business segments to normalize, but at different rates. We continue to expect demand to be in line with what we saw in Q3. And we're hopeful that we'll see a cough and cold season that returns to pre-COVID levels. We did have a minor impact as well from a negative impact from Losartan in Q3, and we continue to expect to see some of those negative impacts in Q4.

現在轉向第四季度。我們確實預計美國以外地區的業績將正常化，我們將繼續努力穩定美國市場。我們預計我們的直接需求業務部門將正常化，但速度會有所不同。我們繼續預計需求將與我們在第三季度看到的一致。我們希望我們會看到咳嗽和感冒的季節恢復到 COVID 之前的水平。我們確實受到了氯沙坦在第三季度的負面影響的輕微影響，我們繼續預計在第四季度會看到其中的一些負面影響。

Now moving to the next slide. We did announce this morning that we're commencing a strategic review of Sandoz, consistent with what we outlined a few years ago. We had stated that we wanted to create a more autonomous Sandoz within Novartis that would give us the optionality to ultimately determine whether is Sandoz best owned by Novartis or by our shareholders or another party. And we believe the GX market is attractive. We think Sandoz is well placed to capitalize on its growth drivers over the next decade. And we think Sandoz is also well placed to really be a leader in the next wave of biosimilars launches.

現在轉到下一張幻燈片。我們今天早上確實宣布，我們將開始對 Sandoz 進行戰略審查，這與我們幾年前概述的內容一致。我們曾表示，我們希望在諾華內部創建一個更加自主的 Sandoz，這將使我們能夠選擇最終確定 Sandoz 是由諾華還是我們的股東或另一方擁有最好的。我們認為 GX 市場具有吸引力。我們認為山德士完全有能力在未來十年利用其增長動力。我們認為山德士也完全有能力成為下一波生物仿製藥推出的領導者。

When you take each of those in turn, attractive market, $400 billion of sales going to LOE over the coming decade, a CAGR of 4%, Sandoz was a #1 position in Europe and in biosimilars as well as a leading position in areas like antibiotics and a clear strategic focus that Richard and his team have put in place. We have a very strong biosimilars pipeline with 15 assets in development, aiming for $3 billion of sales by 2025 and $5 billion by 2030, a clear strategy in complex, small molecules and ongoing margin improvements primarily through improved COGS through our technical operations unit.

當你依次考慮其中每一個時，有吸引力的市場，未來十年將有 4000 億美元的銷售額流向 LOE，複合年增長率為 4%，山德士在歐洲和生物仿製藥領域處於第一的位置，並且在以下領域處於領先地位Richard 和他的團隊已經制定了抗生素和明確的戰略重點。我們擁有非常強大的生物仿製藥管道，其中有 15 項資產正在開發中，目標是到 2025 年銷售額達到 30 億美元，到 2030 年達到 50 億美元，在復雜的小分子方面製定明確的戰略，並通過我們的技術運營部門改善 COGS 來持續提高利潤率。

So we expect to conduct this review over the coming period, and we would plan to provide an update on progress latest by the end of next year. It is notable that Sandoz is more integrated into Novartis than Alcon was historically. And so there are important considerations we'll need to work through from an IT and business services standpoint to really enable us to make the best decision.

因此，我們預計將在未來一段時間內進行這項審查，併計劃在明年年底之前提供最新進展。值得注意的是，山德士比愛爾康更能融入諾華。因此，我們需要從 IT 和業務服務的角度考慮一些重要的考慮因素，以真正使我們能夠做出最佳決策。

Now moving to Slide 13. From a pipeline standpoint, we had a busy quarter, some approvals, a number of readouts -- many readouts that went our way, but also important readouts that didn't go our way. And we acknowledge those and are working to learn from them to continue to improve our pipeline performance. But on balance, we would say we continue to be at the industry. Benchmarks are better in terms of pipeline success rates by phase.

現在轉到幻燈片 13。從管道的角度來看，我們有一個繁忙的季度，一些批准，一些讀數 - 許多讀數符合我們的方式，但也有重要的讀數沒有按照我們的方式進行。我們承認這些，並正在努力向他們學習，以繼續提高我們的管道性能。但總的來說，我們會說我們繼續在這個行業。就分階段的管道成功率而言，基準更好。

From a submissions standpoint, a number of submissions went in. And I think importantly, we received 2 designations, priority reviews for both asciminib and Lu-PSMA-617. Both of those reviews are ongoing and should enable a launch in the relatively near term.

從提交的角度來看，有很多提交。而且我認為重要的是，我們收到了 2 個指定，即 asciminib 和 Lu-PSMA-617 的優先審查。這兩項審查都在進行中，應該能夠在相對近期內推出。

And moving to Slide 14. Going a bit deeper, and we've reframed these next 2 slides rather than looking at pharma and onco to really break it out by business franchise and global franchise of the various businesses. So starting in pharmaceuticals and cardiorenal where, of course, we build on the strong position we have with Entresto. Leqvio, we remain on track for an action date in January 1. We have good discussions with FDA, are continuing to progress the assessment of our Austrian facility. No issues have been flagged. So we remain on track for that approval.

轉到第 14 張幻燈片。再深入一點，我們重新構建了接下來的 2 張幻燈片，而不是著眼於 pharma 和 onco，以真正通過業務特許經營權和各種業務的全球特許經營權來打破它。因此，從製藥和心腎領域開始，當然，我們在 Entresto 的強勢地位基礎上再接再厲。 Leqvio，我們仍有望在 1 月 1 日採取行動。我們與 FDA 進行了良好的討論，正在繼續推進對我們奧地利設施的評估。未標記任何問題。因此，我們仍有望獲得批准。

At Iptacopan, we continue to have solid progress on this medicine with Phase III started in IgA, C3G and atypical hemolytic uremic syndrome. We also disclosed in our quarter that both the final readouts for both C3G and IgA nephropathy, which followed these patients for a bit longer, continued the trend of improving renal function. Pelacarsen continues to perform well in its Phase III.

在 Iptacopan，我們在 IgA、C3G 和非典型溶血性尿毒症綜合徵的 III 期藥物方面繼續取得了堅實的進展。我們還在本季度披露了 C3G 和 IgA 腎病的最終讀數，這些患者的隨訪時間更長，繼續改善腎功能的趨勢。 Pelacarsen 在其第三階段繼續表現良好。

From an immunology standpoint, we announced today that Cosentyx had a positive Phase II readout versus steroids standard of care for giant cell arteritis, and we've moved now to begin a Phase III program. And of course, the hidradenitis readouts are continuing as well as the -- on track as well as the other Phase III programs.

從免疫學的角度來看，我們今天宣布 Cosentyx 與類固醇治療鉅細胞動脈炎的標準相比具有積極的 II 期讀數，我們現在已經開始著手 III 期計劃。當然，汗腺炎的讀數正在繼續，以及 - 在軌道上以及其他 III 期計劃。

Ligelizumab remains on track for its readout, and we'll talk about remibrutinib. I did want to highlight we see very good data, mid-stage data for ianalumab, which is our anti-BAFF receptor antibody. And we'll be presenting more data in the coming quarters on this medicine, but we're excited about its potential in a range of autoimmune as well as hematological indications.

Ligelizumab 的讀數仍在軌道上，我們將討論瑞布替尼。我確實想強調我們看到非常好的數據，ianalumab 的中期數據，這是我們的抗 BAFF 受體抗體。我們將在未來幾個季度提供更多關於這種藥物的數據，但我們對其在一系列自身免疫和血液學適應症方面的潛力感到興奮。

Turning to neuroscience. The SMA intrathecal AVXS-101 intrathecal FDA hold has been lifted as we previously disclosed, and the Phase III now is initiating its -- a global Phase III program covering 2- to 18-year-olds. Branaplam, our splicing inhibitor for -- splicing modulator, I should say, for Huntington's disease, has its Phase IIb now starting with all the relevant regulatory clearances achieved. And we will announce and we've announced, and I will talk a bit more about remibrutinib in a moment.

轉向神經科學。正如我們之前披露的那樣，SMA 鞘內 AVXS-101鞘內 FDA 的持有已被取消，第三階段現在正在啟動其 - 一個覆蓋 2 至 18 歲的全球第三階段計劃。 Branaplam 是我們的剪接抑製劑——我應該說，對於亨廷頓氏病的剪接調節劑，它的 IIb 期現在開始於所有相關的監管許可。我們將宣布，我們已經宣布，稍後我將更多地談論瑞布替尼。

Turning to the next slide from an oncology standpoint. Here, we had, of course, a number of events. We'll talk about Kisqali and canakinumab. Lu-PSMA, we've already mentioned. I did want to flag, we've started now both our earlier-stage studies in the pre-taxane as well as the hormone-sensitive metastatic settings and are continuing to evaluate to move -- potentially move this medicine into earlier lines.

從腫瘤學的角度來看下一張幻燈片。在這裡，我們當然有很多活動。我們將討論 Kisqali 和 canakinumab。 Lu-PSMA，我們已經提到過。我確實想指出，我們現在已經開始在紫杉烷前以及激素敏感的轉移環境中進行早期研究，並且正在繼續評估移動——可能將這種藥物轉移到更早的生產線。

We did announce as well that JDQ443, which is our in-house KRAS inhibitor, has had a good PK, good dose finding. We think it's a very good profile for this medicine and are now moving it into Phase III studies in non-small cell lung cancer, but then we'll also look potentially at other indications. And this enables us to have in our own hands, our own combination of a KRAS inhibitor and a SHP2 inhibitor. Our TNO SHP2 inhibitor is now in a number of early-stage studies looking at combinations. And we'll hopefully be able to present more data on this in the early part of next year.

我們還宣布，我們的內部 KRAS 抑製劑 JDQ443 具有良好的 PK 和良好的劑量發現。我們認為這對這種藥物來說是一個很好的描述，現在正將其轉移到非小細胞肺癌的 III 期研究中，但隨後我們也可能會關注其他適應症。這使我們能夠擁有自己的 KRAS 抑製劑和 SHP2 抑製劑的組合。我們的 TNO SHP2 抑製劑目前正處於多項針對組合的早期研究中。我們希望能夠在明年年初提供更多這方面的數據。

Turning to hematology. Our first-line study for asciminib now has also started. Our PNH for iptacopan is progressing well. Our sabatolimab programs remain on track. And importantly, now with YTB, our next-generation CD19 CAR-T, we've seen very good data in the early phases, which we'll present at ASH, along with our multiple myeloma next phase CAR-T therapy. And we plan to start the pivotal studies in 2022.

轉向血液學。我們對 asciminib 的一線研究現在也已經開始。我們的 iptacopan 的 PNH 進展順利。我們的 sabatolimab 計劃仍在進行中。重要的是，現在有了 YTB，我們的下一代 CD19 CAR-T，我們在早期階段看到了非常好的數據，我們將在 ASH 上展示這些數據，以及我們的多發性骨髓瘤下一階段 CAR-T 治療。我們計劃在 2022 年開始關鍵研究。

So moving to the next slide. Just wanted to say a few words on remibrutinib. This, I think, is a really well-designed medicine. We have excellent chemistry at Novartis. And our scientists have worked to really create a highly selective, potent and safe covalent BTK inhibitor. And when you look at the data in CSU, we're the first BTK inhibitor to be able to demonstrate the kind of data that you see on these slides.

所以轉到下一張幻燈片。只是想對瑞布替尼說幾句話。我認為，這是一種設計精良的藥物。我們在諾華有出色的化學反應。我們的科學家一直致力於真正創造一種高度選擇性、有效且安全的共價 BTK 抑製劑。當您查看 CSU 中的數據時，我們是第一個能夠展示您在這些幻燈片上看到的數據類型的 BTK 抑製劑。

First, a very good dose response with significant improvements versus placebo. And you can see the statistics here are very compelling with no safety signals. Then when you look at the improvements in the relevant urticaria score over placebo, you can see across the dose range, we see a clear improvement versus placebo. And that improvement was very rapid as early as week 1 and maintained through week 12, the endpoint of the study.

首先，與安慰劑相比具有顯著改善的非常好的劑量反應。你可以看到這裡的統計數據非常引人注目，沒有安全信號。然後，當您查看相關蕁麻疹評分相對於安慰劑的改善時，您可以在整個劑量範圍內看到，我們看到與安慰劑相比有明顯改善。早在第 1 週，這種改善就非常迅速，並一直持續到第 12 週，即研究的終點。

Moving to Slide 17. When you look at the complete control that patients on remibrutinib BID were able to achieve versus the placebo group, very high response rates that were consistently maintained over the course of the study, I think, showing the potency of the drug. But in terms of differentiation, particularly in dermatology as well as in multiple sclerosis, we were really pleased with the safety profile of this medicine, which we think will be critically important.

轉到幻燈片 17。當您查看瑞米替尼 BID 患者與安慰劑組相比能夠實現的完全控制時，我認為在研究過程中始終保持非常高的反應率，這表明了藥物的效力.但就分化而言，特別是在皮膚病學和多發性硬化症方面，我們對這種藥物的安全性感到非常滿意，我們認為這將是至關重要的。

One, there was no dose-dependent increases or treatment interruptions or discontinuations due to LFT elevations, no dose-dependent cytopenias or treatment interruptions for low blood cell counts, and no clinically relevant adverse events associated with what have been historically associated with the BTK inhibitor class across the entire dose range tested. So overall, we think this is a potential best-in-class profile for CSU, positive benefit/risk in those Phase III studies are in the midst of starting right now.

第一，沒有因 LFT 升高而導致劑量依賴性增加或治療中斷或中止，沒有劑量依賴性血細胞減少或低血細胞計數導致治療中斷，並且沒有與 BTK 抑製劑歷史相關的臨床相關不良事件在整個測試劑量範圍內進行分類。因此，總的來說，我們認為這是 CSU 潛在的同類最佳概況，這些 III 期研究中的積極收益/風險目前正處於開始階段。

Moving to Slide 18. And as mentioned, we're now initiating Phase III trials with remibrutinib. We understand that we are behind some of our competitors. But we believe our expertise in conducting large-scale RRMS studies gives us the ability to close the gap. And importantly, we think for neurologists, what's really important is they have a very safe medicine that is also high efficacy, and we think we can deliver that with remibrutinib. And what will this allow us to do? We've already got the all-clear to move ahead into our Phase III studies. And what this allows us to do over the longer term is build on our multiple sclerosis portfolio, Gilenya, Mayzent, Kesimpta and now adding eventually, assuming success, remibrutinib.

轉到幻燈片 18。如前所述，我們現在正在啟動瑞布替尼的 III 期試驗。我們知道我們落後於我們的一些競爭對手。但我們相信，我們在開展大規模 RRMS 研究方面的專業知識使我們有能力縮小差距。重要的是，我們認為對於神經病學家來說，真正重要的是他們擁有一種非常安全且高效的藥物，我們認為我們可以使用瑞布替尼來實現這一目標。這將允許我們做什麼？我們已經準備好進入我們的 III 期研究。從長遠來看，這讓我們能夠做的是建立在我們的多發性硬化症產品組合 Gilenya、Mayzent、Kesimpta 的基礎上，假設成功，現在最終增加了 remibrutinib。

So moving to Slide 19. You also saw in the quarter, Kisqali achieved statistically significant OS in the MONALEESA-2 study, the third study where Kisqali in the metastatic setting has demonstrated a significant overall survival benefit, that benefit now up to 5 years. It's really, we believe, should be the preferred treatment option for these patients given the compelling OS data that's been demonstrated. We plan to submit this OS data into our labeling in the relevant geographies.

所以轉到幻燈片 19。您還在本季度看到，Kisqali 在 MONALEESA-2 研究中實現了具有統計學意義的 OS，這是 Kisqali 在轉移性環境中的第三項研究顯示出顯著的總體生存益處，該益處現在長達 5 年。我們認為，鑑於已證明的令人信服的 OS 數據，這確實應該是這些患者的首選治療方案。我們計劃將此操作系統數據提交到我們在相關地區的標籤中。

Moving to Slide 20. I just wanted to say a word as I know there's a lot of interest now in the adjuvant readout, which we expect in 2022. It's on track, fully enrolled. Just to remind you, there's some unique elements of this study, one, it includes patients at high and intermediate risk, which is a larger patient population than some of our competitor studies. And the way we have designed the study, it's to base enrollment on the prognostic staging from the AJCC. A little bit different than the Ki-67 that has gotten a lot of attention, but we believe and with regulatory sign-up, a very relevant prognostic staging to really ensure that we enrich for the risk of recurrence in this study.

轉到幻燈片 20。我只想說一句話，因為我知道現在人們對輔助讀數很感興趣，我們預計在 2022 年。它正在步入正軌，完全註冊。提醒您一下，這項研究有一些獨特的元素，第一，它包括高風險和中等風險的患者，這是比我們的一些競爭對手研究更大的患者群體。我們設計這項研究的方式是根據 AJCC 的預後分期進行註冊。與備受關注的 Ki-67 略有不同，但我們相信，通過監管機構的註冊，這是一個非常相關的預後分期，可以真正確保我們在本研究中增加複發風險。

We have a longer treatment duration of 3 years versus 2 years. We lowered the dose to make sure this was manageable for patients in the adjuvant setting to overall improve the tolerability. So as I said, enrollment complete. It's an event-driven study. We expect the late '22 readout. And feedback from FDA, which we reviewed again, says that the IDFS endpoint is acceptable as the primary analysis provided there's no detriment in OS. And we're, of course, taking that into account as we see the various readouts over the course of next year.

我們的治療時間更長，為 3 年，而不是 2 年。我們降低了劑量，以確保輔助治療中的患者可以控制，從而全面提高耐受性。正如我所說，註冊完成。這是一項事件驅動的研究。我們預計 22 年末的讀數。我們再次審查的來自 FDA 的反饋說，如果對 OS 沒有損害，IDFS 端點作為主要分析是可以接受的。當然，當我們看到明年的各種讀數時，我們會考慮到這一點。

Moving to Slide 21. Now I wanted to turn to CANOPY. And if you'll indulge me, I'll just take a few minutes to explain the data that we released yesterday to make sure it's clear. And then we'll, of course, be happy to take your questions. The CANOPY program is based on the results we saw in CANTOS, where we saw 60% to 70% improvement in the incidence and mortality of lung cancer in a cardiovascular trial. This was based on a pretty good understanding that IL-1 beta as well as hsCRP are very relevant in the tumor microenvironment for lung cancer as well as in other inflammatory cancers.

轉到幻燈片 21。現在我想轉向 CANOPY。如果你願意的話，我只需要幾分鐘時間來解釋一下我們昨天發布的數據，以確保它是清楚的。然後，我們當然會很樂意回答您的問題。 CANOPY 計劃基於我們在 CANTOS 中看到的結果，在心血管試驗中，我們看到肺癌的發病率和死亡率降低了 60% 到 70%。這是基於對 IL-1 β 和 hsCRP 在肺癌以及其他炎症性癌症的腫瘤微環境中非常相關的很好理解。

The CANOPY-2 study was in the second line there. We didn't see any signals of efficacy overall. And there, of course, as you saw at ESMO, the trend was not positive with canakinumab versus the control arm of chemo. In this study, while we did not meet our primary endpoints of OS and PFS in previously untreated, locally advanced, metastatic non-small cell lung cancer, in the overall population, we did see a positive trend though not statistically significant.

CANOPY-2 研究處於第二行。總體而言，我們沒有看到任何有效的信號。當然，正如你在 ESMO 看到的那樣，卡那奴單抗與化療對照組相比，這一趨勢並不樂觀。在這項研究中，雖然我們在先前未治療的局部晚期轉移性非小細胞肺癌中沒有達到 OS 和 PFS 的主要終點，但在總體人群中，我們確實看到了積極的趨勢，儘管沒有統計學意義。

Importantly, we did see potentially clinically meaningful improvements in both PFS and OS. These improvements in these prespecified subgroups and biomarker-driven subgroups were nominally statistically significant. And the upper bound of the confidence interval specifically did not include one. And we saw treatment effects that were meaningful in our view. However, we don't believe at this point in time that this would constitute a fileable program.

重要的是，我們確實看到了 PFS 和 OS 具有潛在臨床意義的改善。這些預先指定的亞組和生物標誌物驅動的亞組的這些改進名義上具有統計學意義。並且置信區間的上限具體不包括一個。我們看到了我們認為有意義的治療效果。但是，我們目前不認為這會構成可歸檔的程序。

Now what we do believe is these results support the continued study of canakinumab in earlier stages of lung cancer. We believe they also support further evaluation of pro-tumor inflammation because the signals we saw were meaningful. On CANOPY-A, the study, we believe, more closely reflects the CANTOS study, it remains a high-risk study to be clear. But nonetheless, we think it's important to complete this study to really understand if there's a possibility to replicate the remarkable findings of the CANTOS study. It's so important for patients if we could actually demonstrate that.

現在我們確實相信這些結果支持卡那奴單抗在肺癌早期階段的繼續研究。我們相信他們也支持進一步評估促腫瘤炎症，因為我們看到的信號是有意義的。在 CANOPY-A 上，我們認為該研究更接近地反映了 CANTOS 研究，但仍需明確這是一項高風險研究。但儘管如此，我們認為完成這項研究以真正了解是否有可能複制 CANTOS 研究的顯著發現是很重要的。如果我們能夠證明這一點，這對患者來說非常重要。

Now in addition, we wouldn't want to highlight, as I think there has been confusion about this. In this study, we did not see meaningful differences in the safety profile of the canakinumab arm versus the control arm of PD-1 plus chemo. So that kind of gives you an overview.

此外，我們不想強調，因為我認為對此存在混淆。在這項研究中，我們沒有看到卡那單抗組與 PD-1 加化療對照組的安全性存在顯著差異。所以那種給你一個概述。

We would note as well, we have a number of other pro-tumor inflammation medicines, oral medicines as well as gevokizumab, which is another anti-IL-1 agent that has regulatory -- or has LOE into the mid-2030s. And of course, we're evaluating that medicine in a few other cancer settings and we'll evaluate as well if there is a credible case to do anything further in metastatic non-small cell lung cancer.

我們還要注意，我們還有許多其他促腫瘤炎症藥物、口服藥物以及 gevokizumab，它是另一種具有監管或 LOE 到 2030 年代中期的抗 IL-1 藥物。當然，我們正在其他一些癌症環境中評估該藥物，我們也會評估是否有可信的案例可以進一步治療轉移性非小細胞肺癌。

Now moving to Slide 22. Lastly, before handing it over to Marie-France, we've accelerated our ESG efforts; 29 million patients reached; a next-generation malarial therapy now entering Phase III studies; a 10-year commitment to really support addressing health inequities and health disparities in the United States; and we've committed to net 0 carbon on top of all of our other environmental commitments using science-based targets to achieve by 2040 and consistent with many of our other large companies that we'll be announcing these at Top 26.

現在轉到幻燈片 22。最後，在將其移交給 Marie-France 之前，我們加快了 ESG 工作；達到2900萬患者；正在進入 III 期研究的下一代瘧疾療法； 10 年承諾真正支持解決美國的健康不平等和健康差距；我們承諾在所有其他環境承諾的基礎上實現淨零碳排放，使用基於科學的目標到 2040 年實現，並與我們將在前 26 名中宣布的許多其他大公司保持一致。

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

有了這個，我會把它交給 Marie-France。

Thank you, Vas. So moving on to Slide 24. Good morning, good afternoon to all. It's my pleasure to share the results of the Pharmaceuticals division for Q3. Sales grew 8% this quarter, driven by a clear focus of our launch drivers, our growth drivers and supported by the solid execution across geographies.

謝謝你，瓦斯。繼續看幻燈片 24。大家早上好，下午好。很高興分享製藥部門第三季度的業績。本季度銷售額增長了 8%，這得益於我們明確關注的啟動驅動因素、增長驅動因素以及跨地區穩健執行的支持。

As you can see, the growth drivers and launches have strong momentum. We're growing 32% and now they account for 54% of sales. This is 10 points above prior year and in line with our strategy. Looking at year-to-date, you can see us accelerating our momentum, and we're on track to have a strong finish to the year.

如您所見，增長動力和發布勢頭強勁。我們增長了 32%，現在他們佔銷售額的 54%。這比去年高出 10 個百分點，符合我們的戰略。從年初至今，您可以看到我們的勢頭正在加速，我們有望在今年取得強勁的成績。

Moving on to Slide 25. Cosentyx grew 22% with solid contribution from both dermatology and rheumatology. In the U.S., we're growing volume with the market. We're holding our leadership position in Europe. And in China, we're leveraging our NRDL listing. China is now our third biggest market. We've also strengthened our evidence base with multiple pediatric indications, further reinforcing the proven efficacy and safety of Cosentyx.

繼續幻燈片 25。 Cosentyx 增長了 22%，皮膚病學和風濕病學都做出了堅實的貢獻。在美國，我們正在隨著市場的增長而增長。我們在歐洲保持著領導地位。在中國，我們正在利用我們的 NRDL 清單。中國現在是我們的第三大市場。我們還通過多種兒科適應症加強了我們的證據基礎，進一步加強了 Cosentyx 的有效性和安全性。

To maintain our momentum in Q4 and beyond, we remain focused on our competitiveness in the field, the flawless execution of our marketing teams and the activation of 2 key groups of patients, those with PSO/PSA comorbidity that need strong efficacy in both skin and joints; and the axial SpA patients who can benefit from all-in-one release.

為了保持我們在第四季度及以後的發展勢頭，我們仍然專注於我們在該領域的競爭力、我們營銷團隊的完美執行以及激活 2 個關鍵患者群體，即患有 PSO/PSA 合併症的患者，這些患者需要對皮膚和關節;以及可以從多合一釋放中受益的軸向 SpA 患者。

So I move on to Slide 26. While Cosentyx has been on the market for 6 years, every year is a launch year. Cosentyx has approved across 5 indications, all of them have low biologic penetration. With a strong value proposition and evidence base, Cosentyx will continue to capture growth. Cosentyx is also the only IL inhibitor with NRDL listing in China. We see strong growth potential in this market.

所以我轉到幻燈片 26。雖然 Cosentyx 已經上市 6 年，但每年都是發布年。 Cosentyx 已批准 5 個適應症，均具有低生物滲透性。憑藉強大的價值主張和證據基礎，Cosentyx 將繼續實現增長。 Cosentyx也是中國唯一列入國家醫保目錄的IL抑製劑。我們看到了這個市場的強勁增長潛力。

We have an ambitious life-cycle management plan, which is starting to deliver. We've seen positive readouts for giant cell arthritis and our IV formulation in Q3. We also expect data for hidradenitis suppurativa in Q4. Overall, we're looking at a potential of 10-plus indications in areas of high unmet need and an ambition to double the number of patients on Cosentyx. This gives us confidence that we can grow Cosentyx to at least $7 billion.

我們有一個雄心勃勃的生命週期管理計劃，該計劃正在開始實施。我們在第三季度看到了鉅細胞關節炎和我們的 IV 製劑的積極讀數。我們還預計第四季度的化膿性汗腺炎數據。總體而言，我們正在研究在高未滿足需求領域的 10 多個適應症的潛力，以及將 Cosentyx 患者數量增加一倍的雄心。這讓我們有信心將 Cosentyx 增長到至少 70 億美元。

Moving on to Slide 27. Entresto grew 44% in the quarter, reaching $2.6 billion year-to-date. The ACC and ESC first-line recommendations for Entresto are translating into penetration gains. And the expanded U.S. label is driving NBRx growth and uptake in primary care.

繼續幻燈片 27。Entresto 本季度增長 44%，年初至今達到 26 億美元。 ACC 和 ESC 對 Entresto 的一線建議正在轉化為滲透率增益。擴大的美國標籤正在推動 NBRx 在初級保健領域的增長和普及。

In Asia, China continues to deliver strong growth on the back of our NRDL listing, and Japan is gaining traction. Both have acceleration potential based on our recent approvals in hypertension. As we pull through the U.S. and the EU guideline recommendations and promote the expanded label in the U.S., we're well set up to maintain growth in Q4.

在亞洲，在我們的 NRDL 上市的支持下，中國繼續實現強勁增長，而日本正在獲得牽引力。根據我們最近在高血壓方面的批准，兩者都具有加速潛力。當我們通過美國和歐盟的指導建議並在美國推廣擴大標籤時，我們已經做好了在第四季度保持增長的準備。

On Slide 28, if we think about the future story of Entresto, it continues in line with our existing trend. We know that there remains significant patient potential. We have 4 million patients on treatment with Entresto today, yet 70% of eligible patients can still benefit. In the U.S., where we have a broad chronic heart failure label, 85% of addressable patients are still on prior standard of care, and that makes ACE and ARB our clear competitive focus. With the recent guideline changes positioning Entresto in first line, we now have an opportunity to drive broader and earlier adoption of Entresto globally. So overall, we're bullish about the continued growth of Entresto to at least $5 billion.

在幻燈片 28 上，如果我們考慮 Entresto 的未來故事，它會繼續符合我們現有的趨勢。我們知道仍有很大的患者潛力。今天，我們有 400 萬患者正在接受 Entresto 治療，但 70% 的合格患者仍然可以受益。在美國，我們擁有廣泛的慢性心力衰竭標籤，85% 的可治療患者仍在接受先前的護理標準，這使得 ACE 和 ARB 成為我們明確的競爭重點。隨著最近將 Entresto 定位在一線的指南更改，我們現在有機會在全球範圍內推動更廣泛和更早地採用 Entresto。所以總的來說，我們看好 Entresto 的持續增長到至少 50 億美元。

If I move on to Slide 29, Zolgensma had a strong quarter and has just surpassed $1 billion in sales for the year. In the U.S., we're treating over 90% of babies according to our label due to the high rates of newborn screening. In Europe, we had strong uptake in Germany and Italy, and we saw a bolus of sales in the U.K. following reimbursement. We expect we've seen the bulk of this in Q3, but we have also reached agreement on reimbursement in Russia and a number of smaller EU markets.

如果我繼續看幻燈片 29，Zolgensma 的季度表現強勁，全年銷售額剛剛超過 10 億美元。在美國，由於新生兒篩查率很高，我們正在根據我們的標籤治療超過 90% 的嬰兒。在歐洲，我們在德國和意大利獲得了強勁的增長，並且在報銷後我們看到了英國的銷售量激增。我們預計我們已經在第三季度看到了大部分情況，但我們也已就俄羅斯和一些較小的歐盟市場的報銷達成協議。

So if we look ahead, we see 4 key drivers of future growth: New markets with Egypt, Saudi Arabia, Beneluxa expected to contribute in Q4; increasing newborn screening so that we can treat patients early on when the benefit of gene therapy is the greatest; heavier patients, our SMART study aims to drive confidence in Zolgensma's value across the full EU label; and intrathecal. Following the alignment of our Phase III study design, we're now one step closer to bringing IT to patients aged 2 to 18 and thus ultimately address the full spectrum of SMA.

因此，如果我們展望未來，我們會看到未來增長的 4 個關鍵驅動因素：埃及、沙特阿拉伯、比荷盧三國預計將在第四季度做出貢獻的新市場；增加新生兒篩查，以便我們能夠在基因治療的益處最大時及早治療患者；對於較重的患者，我們的 SMART 研究旨在提高人們對 Zolgensma 在整個歐盟標籤中的價值的信心；和鞘內。在調整我們的 III 期研究設計之後，我們現在離將 IT 帶給 2 至 18 歲的患者更近了一步，從而最終解決了 SMA 的全部問題。

If I move on to Slide 30, while the multiple sclerosis market has contracted quarter-over-quarter, Kesimpta grew 56%. Importantly, Kesimpta has been a strong driver of the dynamic B-cell market with an additional 1,000 patients on treatment.

如果我繼續看幻燈片 30，雖然多發性硬化症市場環比收縮，但 Kesimpta 增長了 56%。重要的是，Kesimpta 一直是動態 B 細胞市場的強大推動力，另有 1,000 名患者正在接受治療。

Our strategy remains focused on 3 elements: Increasing familiarity, we're maintaining a high share of voice, and we've added more than 500 prescribers versus Q2; driving further clinical differentiation, we just presented 3.5 years of IgG data at ECTRIMS, and we're generating evidence on switching and patient-reported outcomes needed to change clinical practice; we're also focusing on customer experience, ensuring fast onboarding and broad access to make it easy to initiate patients.

我們的戰略仍然專注於 3 個要素：增加熟悉度，我們保持較高的發言權，與第二季度相比，我們增加了 500 多名開藥者；推動進一步的臨床分化，我們剛剛在 ECTRIMS 上展示了 3.5 年的 IgG 數據，我們正在生成關於改變臨床實踐所需的轉換和患者報告結果的證據；我們還專注於客戶體驗，確保快速入職和廣泛訪問，從而輕鬆啟動患者。

We continue to see more than 50% of our uptake in first line for Switch, and we know how important this is because this is where we can have the highest impact on progression and long-term outcomes. We see huge potential in this B-cell market, and we're driving the growth in the dynamic segment. We have the right strategy, and we're going to take further share as the market rebounds.

我們繼續看到超過 50% 的人在 Switch 一線使用，我們知道這有多重要，因為這是我們可以對進展和長期結果產生最大影響的地方。我們看到了這個 B 細胞市場的巨大潛力，我們正在推動動態領域的增長。我們有正確的策略，隨著市場反彈，我們將進一步佔據份額。

Moving on to Slide 31. On Leqvio, you most certainly saw that we received nice approval, and we're currently working to implement our broad reaching commercial agreement with NHS England. We have also been fully focused on the upcoming U.S. launch. We're working closely with health care systems to prioritize ASCVD to identify patients to set up buy-and-bill. And we're also leveraging our Entresto sales force to educate on the unmet need in ASCVD. For customers who may not want buy-and-bill, we're creating a network of alternative injection centers where patients can receive Leqvio. We've signed up more than 1,000 centers and expect them to become a significant factor in pulling through our demand early on.

繼續幻燈片 31。關於 Leqvio，您肯定看到我們得到了很好的批准，我們目前正在努力實施我們與 NHS England 達成的廣泛的商業協議。我們還完全專注於即將在美國推出的產品。我們正在與醫療保健系統密切合作，優先考慮 ASCVD 以確定患者以建立購買和賬單。我們還利用我們的 Entresto 銷售團隊來宣傳 ASCVD 中未滿足的需求。對於可能不想買單的客戶，我們正在創建一個替代注射中心網絡，患者可以在那裡接受 Leqvio。我們已經簽約了 1,000 多個中心，並希望它們成為早期拉動我們需求的重要因素。

We're also ensuring we generate the right evidence needed to succeed in the U.S. market. Based on our engagement, we expect the majority of the 200 prioritized health care systems to start treating patients in 2022. The uptake will be skewed to the second half of the year when the majority of the system should be ready for buy-and-bill and our permanent J code should be issued. We're working with diligence. We're taking a long-term perspective on what needs to be done to transform how ASCVD is treated to make Leqvio one of the biggest medicines for Novartis.

我們還確保我們生成在美國市場取得成功所需的正確證據。根據我們的參與，我們預計 200 個優先醫療保健系統中的大多數將在 2022 年開始治療患者。吸收量將偏向於下半年，屆時該系統的大部分應該準備好購買和開票並且我們的永久J代碼應該被發布。我們正在努力工作。我們正在從長遠的角度考慮需要做些什麼來改變 ASCVD 的治療方式，以使 Leqvio 成為諾華最大的藥物之一。

In summary, we continue to execute against our strategy, maximize our growth drivers, deliver our launches and prepare for the next wave of products. The teams are working with a strong sense of urgency and purpose to be more customer focused, so we can bring our innovation to more patients faster.

總而言之，我們將繼續執行我們的戰略，最大化我們的增長動力，推出我們的產品並為下一波產品做準備。這些團隊正懷著強烈的緊迫感和目標，更加以客戶為中心，因此我們可以更快地將我們的創新帶給更多的患者。

I want to thank the teams around the world for their commitment and show my confidence in the continued momentum for a strong year-end. Now let me hand it over to Susanne.

我要感謝世界各地的團隊的承諾，並表示我對強勁的年終勢頭的持續動力充滿信心。現在讓我把它交給蘇珊娜。

Thank you, Marie-France. Moving to Slide 33. The Oncology business delivered a solid quarter, growing 5% versus prior year with sales of $3.9 billion. Our growth drivers as well as recent launches performed well with 16% growth versus previous year, driven by Jakavi, Promacta/Revolade and Kisqali. Together, these products now contribute to more than half of the overall oncology sales.

謝謝你，瑪麗-法蘭西。轉到幻燈片 33。腫瘤學業務實現了穩健的季度，與去年同期相比增長 5%，銷售額為 39 億美元。在 Jakavi、Promacta/Revolade 和 Kisqali 的推動下，我們的增長動力以及最近推出的產品表現良好，與去年相比增長了 16%。這些產品現在共同貢獻了腫瘤學總銷售額的一半以上。

In the third quarter, we have seen health care systems in oncology slowly returning back to normal as patient visit, diagnosis and treatment rates are gradually improving. We are seeing that new patient starts continue to accumulate and expect this translate into growth acceleration in segments like recent launches and hospital administered products by the end of the year.

在第三季度，隨著患者就診率、診斷率和治療率逐漸提高，我們看到腫瘤醫療系統逐漸恢復正常。我們看到新患者的開始數量繼續增加，並預計這會在今年年底前轉化為近期推出的產品和醫院管理產品等領域的增長加速。

Moving to Slide 34. Kisqali delivered strong performance in the third quarter, growing 27% with sales of $230 million. The uptake was mainly driven by continued very strong momentum and patient share gains ex U.S., particularly in Europe. We achieved market-leading position with 40% patient share in premenopausal patients in the EU4 and U.K. It is a doubling in patient share since we reported overall survival results from MONALEESA-7.

轉到幻燈片 34。 Kisqali 在第三季度表現強勁，增長 27%，銷售額為 2.3 億美元。這種吸收主要是由於持續非常強勁的勢頭和美國以外的患者份額增加，特別是在歐洲。我們在 EU4 和英國的絕經前患者中以 40% 的患者份額實現了市場領先地位。自從我們報告了 MONALEESA-7 的總體生存結果以來，患者份額翻了一番。

In the U.S., Kisqali grew 5% versus previous year, driven by increased demand in pre- and post-menopausal patients, with usage shifting to earlier lines of therapy, which is very encouraging. And as you heard from Vas, we are very excited about the new OS data for MONALEESA-2 that showed the longest overall survival ever reported in advanced breast cancer, achieving a median overall survival of over 5 years.

在美國，由於絕經前和絕經後患者的需求增加，Kisqali 與上一年相比增長了 5%，而且使用轉移到了更早的治療線，這非常令人鼓舞。正如您從 Vas 那裡聽到的，我們對 MONALEESA-2 的新 OS 數據感到非常興奮，該數據顯示晚期乳腺癌的總生存期最長，中位總生存期超過 5 年。

We believe that such impressive results are the evidence of Kisqali's ability to change tumor biology to enable a better response to endocrine-based therapy. Kisqali is now the only CDK4/6 inhibitor with proven OS benefit across all 3 Phase III trials of the MONALEESA program with different endocrine therapy partners regardless of menopausal status or line of therapy.

我們相信，如此令人印象深刻的結果證明了 Kisqali 有能力改變腫瘤生物學，從而更好地應對基於內分泌的治療。 Kisqali 現在是唯一一種 CDK4/6 抑製劑，在 MONALEESA 計劃的所有 3 項 III 期試驗中，無論絕經狀態或治療線如何，均具有不同的內分泌治療合作夥伴，具有 OS 益處。

Therefore, with a lot of confidence in Kisqali, we have started a collaboration with SOLTI and initiated a Phase III trial called HARMONIA to evaluate ribociclib versus palbociclib in patients with aggressive HER2-enriched intrinsic subtype of HR-positive HER2 advanced breast cancer.

因此，我們對 Kisqali 充滿信心，開始與 SOLTI 合作並啟動一項名為 HARMONIA 的 III 期試驗，以評估 ribociclib 與 palbociclib 在侵襲性 HER2 富集內在亞型 HR 陽性 HER2 晚期乳腺癌患者中的療效。

As Vas said, we are also very excited about the Ativan NATALEE study that is exploring Kisqali in both intermediate and high-risk population. And this would have the potential to more than triple patients of the metastatic setting. NATALEE study completed enrollment ahead of schedule in second quarter of this year, and we are looking forward to a readout in 2022.

正如 Vas 所說，我們也對 Ativan NATALEE 研究感到非常興奮，該研究正在中高風險人群中探索 Kisqali。這將有可能使轉移性環境中的患者增加三倍以上。 NATALEE 研究在今年第二季度提前完成了招生，我們期待著 2022 年的結果。

Moving to the next slide. I am pleased to share with you that our 2 blockbusters in the hematology franchise, Promacta/Revolade and Jakavi continue to deliver very strong double-digit performance, driven by strong demand across all regions. Promacta/Revolade is our thrombopoietin receptor agonist indicated for use in ITP and severe aplastic anemia.

轉到下一張幻燈片。我很高興與您分享我們在血液學專營權中的兩部重磅炸彈 Promacta/Revolade 和 Jakavi 在所有地區強勁需求的推動下繼續提供非常強勁的兩位數業績。 Promacta/Revolade 是我們的血小板生成素受體激動劑，適用於 ITP 和嚴重再生障礙性貧血。

The brand continued to perform very strongly, driven by sustained efficacy, oral convenience and nonimmunosuppressive profile. In the U.S. alone, we have seen 10% increase in new patient starts versus previous year and expecting that further uptake will be fueled with the expansion of the U.S. indication to include persistent ITP.

在持續療效、口服方便和非免疫抑制特性的推動下，該品牌繼續表現強勁。僅在美國，我們就看到新患者開始與去年相比增加了 10%，並預計隨著美國適應症的擴大，包括持續性 ITP，將進一步推動這一增長。

Ex U.S., Revolade is also performing strongly, driven by increased use in both indications and also additional demand from China. Jakavi is our drug inhibitor and the standard of care in myelofibrosis and polycythemia vera and has also demonstrated impressive growth with significant uptake coming from earlier use in both indication and strong momentum in China. We have completed filings in acute and chronic graft versus host disease in the EU and are actively preparing for launches in 2022. So overall, I'm very pleased with the performance of these 2 important hematological brands and the potential they have in terms of future growth and patient benefit.

除美國外， Revolade 的表現也很強勁，這主要得益於在這兩種適應症中的使用增加以及來自中國的額外需求。 Jakavi 是我們的藥物抑製劑，也是骨髓纖維化和真性紅細胞增多症的標準治療藥物，並且由於早期在中國的適應症和強勁勢頭的使用而顯示出令人印象深刻的增長。我們已經在歐盟完成了急性和慢性移植物抗宿主病的備案，並正在積極準備在 2022 年推出。所以總的來說，我對這兩個重要的血液學品牌的表現以及它們在未來方面的潛力感到非常滿意成長和患者受益。

Moving to Slide 36. I would like to update you on how we are preparing for the upcoming launches of asciminib and Lu-PSMA-617. Asciminib is our STAMP inhibitor that has the potential to transform the standard of care in CML. In the Phase III ASCEMBL study, asciminib nearly doubled the major molecular response rate at 24 weeks compared to bosutinib. Asciminib is well positioned for launch in third-line CML as we are preparing to leverage our broad commercial footprint and the established collaboration with the hematology community.

轉到幻燈片 36。我想向您介紹我們如何為即將推出的 asciminib 和 Lu-PSMA-617 做準備。 Asciminib 是我們的 STAMP 抑製劑，有可能改變 CML 的護理標準。在 III 期 ASCEMBL 研究中，與 bosutinib 相比，asciminib 在 24 週時的主要分子反應率幾乎翻了一番。 Asciminib 已準備好在三線 CML 中推出，因為我們正準備利用我們廣泛的商業足跡和與血液學界的既定合作。

We are pleased to see a very high prelaunch awareness of 80% amongst dermatologists. We have completed FDA and EMA filing earlier in June. The U.S. FDA has granted 2 breakthrough therapy designations and Fast Track designation for asciminib and is reviewing the file under real-term oncology review with approval expected early next year.

我們很高興看到 80% 的皮膚科醫生在發布前的認知度非常高。我們已在 6 月初完成了 FDA 和 EMA 申報。美國 FDA 已授予阿西米尼 2 項突破性治療指定和快速通道指定，並正在審查實時腫瘤學審查中的文件，預計將於明年初獲得批准。

And just to remind you that asciminib has blockbuster potential in the third line. But we are also seeing opportunity to address the unmet need in first-line CML, and therefore, have initiated a Phase III study of asciminib versus investigator-selected TKIs with final readout expected in 2024.

並且只是提醒您，asciminib 在第三行具有重磅炸彈的潛力。但我們也看到了解決一線 CML 未滿足需求的機會，因此，我們啟動了 asciminib 與研究者選擇的 TKI 的 III 期研究，最終結果預計在 2024 年公佈。

Another exciting asset that we are preparing to launch is our radioligand therapy, lutetium-PSMA-617 that has demonstrated significant OS and rPFS benefit in advanced metastatic prostate cancer. Our awareness campaign on PSMA and phenotypic precision medicine is progressing well with the awareness among target physicians doubling over the last 12 months. Our focus is on the top 200 treatment centers and education about process optimation as well as on treatment site expansion to ensure site readiness at launch.

我們準備推出的另一項激動人心的資產是我們的放射性配體療法，镥-PSMA-617，它已在晚期轉移性前列腺癌中證明了顯著的 OS 和 rPFS 益處。我們對 PSMA 和表型精準醫學的宣傳活動進展順利，目標醫生的意識在過去 12 個月翻了一番。我們的重點是前 200 家治療中心和有關工藝優化的教育以及治療場地的擴展，以確保場地在啟動時做好準備。

We completed filing with FDA. And in addition to breakthrough therapy designation, also received priority review with PDUFA date in the first half of 2022. In addition, we have completed filing to FDA for registration of our own gallium PSMA-11 PET kit to further support availability of imaging agents. And submission of both lutetium-PSMA and gallium PSMA PET to the EMA is on track. So we are moving with confidence into earlier lines of therapy and have initiated 2 Phase III studies with lutetium-PSMA in metastatic hormone-sensitive prostate cancer and in pre-taxane metastatic prostate cancer. So overall, very much looking forward to bringing these 2 assets to market.

我們完成了向 FDA 的備案。除了突破性治療指定外，我們還在 2022 年上半年獲得了 PDUFA 日期的優先審查。此外，我們已完成向 FDA 提交我們自己的鎵 PSMA-11 PET 試劑盒的註冊，以進一步支持顯像劑的可用性。向 EMA 提交镥-PSMA 和鎵 PSMA PET 的工作正在進行中。因此，我們滿懷信心地轉向早期的治療線，並已啟動了 2 項關於镥-PSMA 在轉移性激素敏感性前列腺癌和紫杉烷前轉移性前列腺癌中的 III 期研究。所以總的來說，非常期待將這兩種資產推向市場。

And with that, I hand over to Harry.

有了這個，我交給哈利。

Yes. Thank you, Susanne. Good morning and good afternoon, everyone. I'm now going to walk you through some of the financials for the third quarter and the first 9 months of the year. And as always, my comments refer to growth rates in constant currencies, unless otherwise noted.

是的。謝謝你，蘇珊。大家早上好，下午好。我現在將向您介紹第三季度和今年前 9 個月的一些財務狀況。與往常一樣，除非另有說明，否則我的評論指的是固定貨幣增長率。

So on Slide 38, we see the summary of our operational performance for the third quarter and the first 9 months, very solid quarter 3 with strong performance of our Innovative Medicines division. As we had anticipated, the business is normalizing post COVID-19 with group sales up 5% and core operating income growth of 9%. Quarter 3 net sales reached $13 billion, driven by the Innovative Medicines growth drivers.

因此，在幻燈片 38 上，我們看到了第三季度和前 9 個月的運營業績摘要，第三季度非常穩健，我們的創新藥物部門表現強勁。正如我們預期的那樣，在 COVID-19 之後，該業務正在正常化，集團銷售額增長 5%，核心營業收入增長 9%。在創新藥物增長動力的推動下，第三季度淨銷售額達到 130 億美元。

Core operating income of $4.5 billion was driven by higher sales and productivity programs across the business. Core EPS was up 11% to $1.71, and free cash flow grew very strongly by plus 64% in U.S. dollar to $4.4 billion.

45 億美元的核心營業收入是由整個企業更高的銷售和生產力計劃推動的。核心每股收益增長 11% 至 1.71 美元，自由現金流非常強勁地增長了 64% 至 44 億美元。

Year-to-date performance reflects the slower growth in the first half of the year, mainly due to the impact of COVID in certain parts of our business. We grew top and bottom line 4%, and core EPS grew 7% to $4.88. And free cash flow was $10.3 billion, growing 23% in U.S. dollars.

年初至今的業績反映了上半年增長放緩，主要是由於 COVID 對我們某些業務的影響。我們的收入和利潤增長了 4%，核心每股收益增長了 7%，達到 4.88 美元。自由現金流為 103 億美元，以美元計算增長 23%。

Next slide, please. On Slide 39, I want to break down our performance by division. And as mentioned, the solid performance of the company was driven by Innovative Medicines, which delivered a strong quarter with 7% top line growth, 13% bottom line growth and a margin of almost 38%. Looking to the first 9 months for the year, Innovative Medicine showed a healthy growth of 6% on top line and 8% on the bottom line with margins of 37%. I'd just like to remind you of the seasonality of margins. As you know, the fourth quarter has usually the lowest margin due to higher spending phasing.

請下一張幻燈片。在幻燈片 39 上，我想按部門細分我們的表現。如前所述，公司的穩健表現受到創新藥物的推動，該季度實現了強勁的季度增長，收入增長 7%，利潤增長 13%，利潤率接近 38%。展望今年前 9 個月，Innovative Medicine 的收入和利潤分別增長了 6% 和 8%，利潤率為 37%。我只想提醒您利潤率的季節性。如您所知，由於支出階段性增加，第四季度的利潤率通常最低。

Innovative Medicines' year-to-date performance was driven by continued strong double-digit growth of the key brands, Vas and Marie-France and Susanne mentioned, with $3.5 billion sales, growing 18% for Cosentyx, Entresto with $2.6 billion, growing 41%. Zolgensma reached already $1 billion in sales. The Kesimpta launch was accelerating. Additionally, the onco key growth drivers continue to do very well.

創新藥物的年初至今業績是由 Vas 和 Marie-France 以及 Susanne 提到的主要品牌持續強勁的兩位數增長推動的，Cosentyx 銷售額為 35 億美元，增長 18%，Entresto 銷售額為 26 億美元，增長 41 %。 Zolgensma 的銷售額已經達到 10 億美元。 Kesimpta 的發射正在加速。此外，onco 的主要增長動力繼續表現良好。

Moving to Sandoz. Nine months performance reflects a heavier impact from COVID than in the other parts of the business. However, in quarter 3, Sandoz has seen some recovery, particularly ex U.S., where sales grew 3%, driven by both biopharmaceuticals and retail generics. U.S. sales were impacted by double-digit price erosion, partnership terminations as well as higher off-contract sales in the prior year.

搬到山德士。九個月的業績反映了 COVID 對業務其他部分的影響更大。然而，在第三季度，山德士出現了一些復甦，尤其是在美國以外的地區，在生物製藥和零售仿製藥的推動下，銷售額增長了 3%。美國銷售額受到兩位數價格侵蝕、合作夥伴關係終止以及上一年合同外銷售額增加的影響。

The U.S. continues to be a challenging business environment for the wider generics market. However, we expect the situation to improve also in the U.S. in the midterm as the impact of COVID-19 lessens and our biosimilar launches begin to deliver.

對於更廣泛的仿製藥市場而言，美國仍然是一個充滿挑戰的商業環境。然而，隨著 COVID-19 的影響減弱並且我們的生物仿製藥產品開始交付，我們預計中期美國的情況也會有所改善。

On Slide 40, I just want to highlight the impressive growth we have seen free cash flow, which is now $10.3 billion for the first 9 months, up 23% compared to the prior year. The main drivers of this have been higher operating income, lower payment from legal matters compared to what we had last year and favorable working capital.

在幻燈片 40 上，我只想強調我們看到的自由現金流令人印象深刻的增長，前 9 個月為 103 億美元，與去年相比增長了 23%。與去年相比，其主要驅動因素是更高的營業收入、更低的法律事務費用以及有利的營運資金。

Now turning to our full year guidance on Slide 41. Overall, for the group, we confirmed the current guidance. For sales, we continue to expect low to mid-single-digit growth. And for the bottom line, we expect mid-single-digit growth ahead of sales. For Innovative Medicines and Sandoz, we are confirming the top line guidance, but we are fine-tuning our bottom line guidance. We continue to expect Innovative Medicines division sales to grow mid-single digits.

現在轉向我們對幻燈片 41 的全年指導。總體而言，對於該集團，我們確認了當前的指導。對於銷售，我們繼續預計低到中個位數的增長。對於底線，我們預計銷售額將實現中個位數增長。對於創新藥物和山德士，我們正在確認頂線指導，但我們正在微調我們的底線指導。我們繼續預計創新藥物部門的銷售額將增長中個位數。

Reflecting the strong performance of the division, we have revised upwards core operating income guidance, which we now expect to grow high single digit. For Sandoz, we continue to expect sales to decline in the low to mid-single-digit range, but we now expect core operating income to decline mid- to high teens. The key assumption for the guidance is that we see a continuation of the return to normal global health care systems and prescription dynamics in the remainder of the year. And in addition, we continue to assume that no Gilenya and no Sandostatin LAR generics enter the U.S. market in 2021.

為反映該部門的強勁表現，我們上調了核心營業收入指引，我們現在預計其將增長高個位數。對於山德士，我們繼續預計銷售額將在中低個位數範圍內下降，但我們現在預計核心營業收入將下降中高位數。該指南的關鍵假設是，我們看到在今年剩餘時間內繼續恢復正常的全球醫療保健系統和處方動態。此外，我們繼續假設 Gilenya 和 Sandostatin LAR 仿製藥在 2021 年不會進入美國市場。

Next slide, please. We thought it might be helpful to you to outline our expectations for the fourth quarter. In short, we expect a similar growth in quarter 4 as we had it in quarter 3, with the top line growing the mid-single-digit range and bottom line growing high single digits. Taking into account our year-to-date 4% growth both for top and bottom line, this brings us to our full year guidance of low to mid-single-digit growth for sales and mid-single-digit growth for the core operating income line.

請下一張幻燈片。我們認為概述我們對第四季度的預期可能對您有所幫助。簡而言之，我們預計第 4 季度的增長與第 3 季度的增長相似，收入增長中個位數範圍，利潤增長高個位數。考慮到我們年初至今的收入和利潤均增長 4%，這使我們的全年銷售額實現了中低個位數增長，核心營業收入實現了中個位數增長線。

Finally, on Slide 43. As currencies are constantly changing, I want to bring to your attention the estimated impact currencies would have on our results using the current exchange rates. So if late October rates prevail for the remainder of 2021, the full year impact of currencies would be a positive 2 points on both sales and core operating income. For quarter 4, it would be negative 1% point on sales and between 0% and negative 1% point on core operating income. And as a reminder, we always update these impacts of the currencies on our website on a monthly basis.

最後，在幻燈片 43 上。由於貨幣在不斷變化，我想提請您注意貨幣對使用當前匯率的結果的估計影響。因此，如果 10 月下旬的利率在 2021 年剩餘時間內占主導地位，那麼貨幣對全年銷售和核心營業收入的影響將是正的 2 個百分點。第 4 季度，銷售額為負 1%，核心營業收入為 0% 至負 1%。提醒一下，我們總是每月更新這些貨幣對我們網站的影響。

And with that, I hand it over back to Vas.

有了這個，我把它交還給 Vas。

Thank you, Harry. So moving to Slide 45. We did want to give you an update on some of the events we'll be holding later this year and into next year. Based on feedback from our investors, we've decided to convert our December 2 event, our Capital Markets Day, to a focused R&D event on innovative medicines. Here, we'll go over our R&D asset, life-cycle management programs, our mid-stage portfolio in each of our key therapeutic areas as well as well as have our numerous scientists on hand to discuss our technology platforms and other efforts within NIBR. And on May 23 and 24 of 2022, we'll plan for a Meet Novartis Management event, which we hope to hold in person.

謝謝你，哈利。所以轉到幻燈片 45。我們確實想向您介紹我們將在今年晚些時候和明年舉行的一些活動的最新情況。根據投資者的反饋，我們決定將 12 月 2 日的資本市場日活動轉變為專注於創新藥物的研發活動。在這裡，我們將回顧我們的研發資產、生命週期管理計劃、我們在每個關鍵治療領域的中期產品組合，以及我們眾多的科學家在場討論我們的技術平台和 NIBR 內的其他努力.並且在 2022 年 5 月 23 日至 24 日，我們將計劃舉辦一場與諾華管理層會面的活動，我們希望能夠親自舉辦。

So moving to Slide 46. In closing, a solid quarter, strong performance from Innovative Medicines. We braced our peak sales guidance, really demonstrating our confidence in the long-term growth of the company. We remain confident in the pipeline, in the launch brands to fuel our growth not only in the midterm, but also with our science-based intervention for the longer term. And we've announced a strategic review of Sandoz, a leading business in generics, operating in an attractive market, but this is the right moment to really evaluate who is the best owner for that business for the long term.

所以轉到幻燈片 46。最後，一個穩健的季度，創新藥物的強勁表現。我們支持最高銷售指導，真正展示了我們對公司長期增長的信心。我們仍然對管道和推出品牌充滿信心，不僅在中期推動我們的增長，而且在長期內通過我們基於科學的干預來推動我們的增長。我們還宣布了對仿製藥領先企業 Sandoz 的戰略審查，該企業在有吸引力的市場中運營，但現在是真正評估誰是該企業長期最佳所有者的正確時機。

So thank you very much for listening, and we'll open the line up for questions. (Operator Instructions) So with that, operator, please open the line.

非常感謝您的收聽，我們將打開排隊提問。 （操作員說明）因此，操作員，請打開線路。

(Operator Instructions) Your first question comes from the line of Graham Parry from Bank of America.

（操作員說明）您的第一個問題來自美國銀行的 Graham Parry。

So it's on NATALEE and your comments on the slide that you've rereviewed the FDA feedback and that invasive disease-free survival is acceptable as a primary endpoint provided no detriment to overall survival. And that seems contrary to how it's treated Lilly's Verzenio, where they were asking for more OS data to see if the curves are separating. So can you just clarify when was that feedback given? And why do you think FDA could treat Kisqali differently from Verzenio? And are you stratifying by Ki-67 score as well given the FDA was also interested in or only approved in that biomarker population for Verzenio?

因此，在 NATALEE 和您對幻燈片的評論中，您已經重新審查了 FDA 的反饋，並且認為無侵入性無病生存作為主要終點是可以接受的，但不會損害總體生存。這似乎與 Lilly 的 Verzenio 的處理方式相反，他們要求更多的操作系統數據來查看曲線是否分離。那麼你能澄清一下什麼時候給出的反饋嗎？為什麼你認為 FDA 可以對 Kisqali 與 Verzenio 區別對待？鑑於 FDA 也對 Verzenio 的生物標誌物群體感興趣或僅批准了該群體，您是否也按 Ki-67 評分進行分層？

Thanks, Graham. John?

謝謝，格雷厄姆。約翰？

Yes. Thanks for the question, Graham. And we did have discussions with the FDA on our NATALEE trial. As you know, we increased the sample size for our NATALEE trial, knowing the criteria that we've included for the overall study population.

是的。謝謝你的問題，格雷厄姆。我們確實與 FDA 就我們的 NATALEE 試驗進行了討論。如您所知，我們增加了 NATALEE 試驗的樣本量，了解我們為整個研究人群所包含的標準。

These discussions were recent. I would say that it was within the end of the third quarter where we had these discussions, and they gave us very clear feedback that the design and the endpoints actually would be supportive based on the invasive DFS endpoint given that, obviously, the results would be based upon the overall totality of the evidence that's available.

這些討論是最近的。我想說的是在第三季度末我們進行了這些討論，他們給了我們非常明確的反饋，即設計和端點實際上將基於侵入性 DFS 端點提供支持，因為顯然，結果將以現有證據的整體為基礎。

As Vas disclosed earlier and shared with you, we have looked at the overall patient population. We've looked at the overall population focused on intermediate and high-risk patients in this study, which is based on the AJCC criteria. That also includes biomarkers and gene expression tests to select the high-risk patient population overall. So what we also know is based on the intermediate risk population, the IDFS rates are similar in this intermediate risk population as in the high-risk population. So based on the overall totality of the background here, we're very confident in our approach.

正如 Vas 之前披露並與您分享的那樣，我們研究了整個患者群體。在本研究中，我們查看了以中高風險患者為重點的總體人群，該研究基於 AJCC 標準。這還包括生物標誌物和基因表達測試，以選擇總體上的高危患者群體。所以我們也知道，基於中等風險人群，這個中等風險人群的 IDFS 率與高風險人群相似。因此，基於這裡的整體背景，我們對我們的方法非常有信心。

Maybe just wanted to -- I think you asked specifically. We do collect Ki-67 data in the study. But right now, that's not part of our statistical analysis plan. And of course, we'll share that data with the FDA when requested.

也許只是想——我想你是特別問的。我們確實在研究中收集了 Ki-67 數據。但現在，這不是我們統計分析計劃的一部分。當然，我們會在要求時與 FDA 共享這些數據。

Thanks, Graham. Next question.

謝謝，格雷厄姆。下一個問題。

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。

Just on the Sandoz strategic review, I wonder if you can give us some insights into perhaps what internally there are metrics that you're perhaps assessing or looking at during the course of next year. And also whether or not there's still the aim to both, I guess, return this business to growth, but also still potentially put the margins back on a positive trajectory before the business is separated? Or if you now believe that the U.S. oral solids business is now essentially in terminal decline, and that business is not a business that you feel is appropriate to be part of Novartis?

就 Sandoz 戰略審查而言，我想知道您是否可以向我們提供一些見解，了解您在明年可能正在評估或查看的內部指標。而且，我想，是否仍然有兩個目標，即使該業務恢復增長，但在業務分離之前仍有可能使利潤率回到正軌？或者，如果您現在認為美國口服固體藥物業務現在基本上處於衰退期，並且您認為該業務不適合成為諾華的一部分？

Thanks, Peter. So I think as always, and as we learn through our Alcon review as well, we consider a number of factors. One, of course, is the synergies between our Innovative Medicines business and Sandoz business as well as the dissynergies between holding both of these businesses. We also consider, I think, capital allocation and capital allocation measures to ensure we're optimally allocating capital to maximize shareholder returns.

謝謝，彼得。所以我一如既往地認為，當我們通過我們的愛爾康審查了解到時，我們會考慮許多因素。其中之一當然是我們的創新藥物業務和山德士業務之間的協同效應，以及持有這兩項業務之間的協同效應。我認為，我們還考慮資本配置和資本配置措施，以確保我們優化資本配置以最大化股東回報。

We, of course, want to consider what would enable us to build the best generics company at the aspiration to be a leading generics company in the world and which setup would best enable that. So I mean those are all in broad strokes, the factors. And I think you saw with the Alcon spin that we're adaptive at understanding these factors, hopefully, making the best decision for our shareholders and the relevant businesses and then taking the relevant actions.

當然，我們想考慮什麼能讓我們建立最好的仿製藥公司，以成為世界領先的仿製藥公司，以及哪種設置最能實現這一目標。所以我的意思是這些都是廣義的因素。而且我認為您從愛爾康的旋轉中看到，我們在理解這些因素方面具有適應性，希望能為我們的股東和相關業務做出最佳決策，然後採取相關行動。

Harry, anything you want to add?

哈利，你有什麼要補充的嗎？

I think, Peter, of course, all of the other details, right, the different options have different tax implications. If it would not be retaining the business, all of those, you would expect that we would, of course, always consider. But I think all of this will be part of our strategic review. And I think fundamentally, the question comes down to who's the best owner of this very good generic business.

我認為，彼得，當然，所有其他細節，對，不同的選擇有不同的稅收影響。如果它不會保留業務，所有這些，您會期望我們當然會始終考慮。但我認為所有這些都將成為我們戰略審查的一部分。而且我認為從根本上說，問題歸結為誰是這個非常好的通用業務的最佳所有者。

Maybe Richard, on the growth profile. Richard?

也許是理查德，關於增長概況。理查德?

Yes. Thank you, Vas. I mean, Peter, you commented about the U.S. I mean clearly, the U.S. business, we've just had very few launches in terms of oral solids over the last year, 18 months. And clearly, we're watching out a number of the partnership deals as well.

是的。謝謝你，瓦斯。我的意思是，彼得，你評論了美國。我的意思很清楚，美國業務，在過去的 18 個月裡，我們在口服固體方面的發布很少。顯然，我們也在關註一些合作交易。

The medium, long term looks much more attractive, both as we accelerate the number of small molecule launches. But also more importantly, we bring a number of biosimilars to the marketplace over the next 3, 4 years, which should materially change the direction of the business, both in the U.S. It's also worth noting that the European business now is back into growth as is our international business. So broadly, it's starting to normalize post-COVID.

中長期看起來更具吸引力，因為我們加快了小分子發射的數量。但更重要的是，我們將在未來 3、4 年內將一些生物仿製藥推向市場，這將極大地改變美國的業務方向。同樣值得注意的是，歐洲業務現在已恢復增長，因為是我們的國際業務。從廣義上講，它開始使後COVID正常化。

Thanks, Richard. Thanks, Peter, for the question. Next question, operator.

謝謝，理查德。謝謝彼得的問題。下一個問題，接線員。

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。

Question for John, relates to canakinumab. John, if I remember in CANTOS, the early separation of the curve, the treatment effect that we saw with canakinumab was attributed to occult metastatic disease in these patients. With that in mind, assuming it is a viable mechanism, should we expect an interim analysis to read out positively? And if it doesn't, we should, therefore, assume the probability of success is very low.

約翰的問題，與 canakinumab 有關。約翰，如果我記得在 CANTOS 中，曲線的早期分離，我們用卡那奴單抗看到的治療效果歸因於這些患者的隱匿性轉移性疾病。考慮到這一點，假設它是一個可行的機制，我們是否應該期待中期分析得到積極的解讀？如果沒有，我們應該因此假設成功的概率非常低。

And then separately, perhaps you could comment on whether even there's any role for this drug given this is an increasingly well-served indication, meaning the adjuvants with Tecentriq, Tagrisso, and more indication -- more drugs on the way.

然後另外，也許你可以評論這種藥物是否有任何作用，因為這是一個越來越好的適應症，這意味著有 Tecentriq、Tagrisso 和更多適應症的佐劑——更多的藥物正在開發中。

Yes. Andrew, I'll take it, obviously, because I was one year with the CANTOS study when I was development head. So in that result, I think, first and foremost, it's important to note that the CANTOS study had an inclusion criteria of 2 milligrams of per DL of hsCRP. The median was in that kind of 2 to 5 range in the overall study population.

是的。安德魯，很明顯，我會接受它，因為當我擔任開發主管時，我在 CANTOS 研究中待了一年。所以在這個結果中，我認為，首先，重要的是要注意 CANTOS 研究的納入標準是每 DL 2 毫克 hsCRP。在整個研究人群中，中位數在 2 到 5 的範圍內。

Our hypothesis at the time was that these were undetected cancers, cancers were -- that were not detected in the screening, either through physical diagnosis or imaging that in the course of the study, canakinumab was able to reduce the incidence of these cancers becoming fulminant and the mortality of these patients. This, we believed, was due to IL-1 beta's role in the tumor microenvironment and IL-1 beta potentially having a role in enabling and blocking IL-1 beta, enabling immune cells to enter the cancer and therefore, potential synergistic effect in the metastatic setting. And in the adjuvant setting, that in the initial stages of a tumor's development, that IL-1 beta plays an important role.

我們當時的假設是這些是未被發現的癌症，癌症是 - 在篩查中沒有發現，無論是通過物理診斷還是成像，在研究過程中，canakinumab 能夠降低這些癌症的發病率成為暴發性以及這些患者的死亡率。我們認為，這是由於 IL-1 β 在腫瘤微環境中的作用，而 IL-1 β 可能在啟用和阻斷 IL-1 β 方面發揮作用，使免疫細胞能夠進入癌症，因此，在腫瘤微環境中的潛在協同作用轉移性設置。在輔助環境中，即在腫瘤發展的初始階段，IL-1 β 發揮著重要作用。

So I don't think that an interim read on this is going to be meaningful. I think the study was going to have to go to the end. We believe the positioning of the medicine is very much -- the canakinumab, in our view, has a very favorable safety profile given the long experience we have treating children with this medicine who find it very well tolerated. We didn't see any differences in this first-line setting.

因此，我認為對此進行臨時閱讀不會有意義。我認為這項研究將不得不進行到最後。我們認為該藥物的定位非常重要——在我們看來，鑑於我們用這種藥物治療兒童的長期經驗，並且發現它的耐受性非常好，canakinumab 具有非常有利的安全性。我們沒有看到這個一線設置有任何差異。

And so having the potential, and I would say it's high risk, to be clear, of an all-comers therapy for the adjuvant setting that does not require any PD-1 screening could be attractive. Now whether physicians choose an IL-1 beta therapy or a PD-1 inhibitor, that will all have to be figured out. But it's important to note as well the adjuvant CANOPY-A study is an all-comers based on what we knew at the time from the CANTOS study and is the lowest CRP group of these studies in terms of the median CRP levels and the enrolled patients, most consistent with the CANTOS study.

因此，在不需要任何 PD-1 篩查的輔助環境中，具有潛力（我會說這是高風險的）可能很有吸引力。現在，無論醫生選擇 IL-1 β 療法還是 PD-1 抑製劑，都必須弄清楚。但同樣重要的是要注意，輔助 CANOPY-A 研究是基於我們當時從 CANTOS 研究中了解到的所有參與者，並且就中位 CRP 水平和入組患者而言，是這些研究中最低的 CRP 組，最符合 CANTOS 研究。

Thank you, Andrew. Next question, operator.

謝謝你，安德魯。下一個問題，接線員。

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。

Just on your new Entresto peak sales guidance, does that $5 billion number capture the possibility of an LOE earlier than the 2025 anchor date that we've been talking about so far?

就您的新 Entresto 峰值銷售指導而言，這個 50 億美元的數字是否反映了 LOE 早於我們迄今為止一直在談論的 2025 年錨定日期的可能性？

Marie-France?

瑪麗-法蘭西？

Yes. So for our internal forecasting assumptions, we're looking at 2025, and that's how we've forecasted. So if you'd like a little bit more detail on why we feel comfortable with the $5 billion plus on Entresto, it's really based on the significant market potential, the further implementation of guidelines and obviously, the recent launches in Asia. And that leads us to a $5 billion plus mark, but that is assuming, for internal guidance, a 2025 LOE.

是的。因此，對於我們的內部預測假設，我們著眼於 2025 年，這就是我們的預測方式。因此，如果您想更詳細地了解為什麼我們對 Entresto 的 50 億美元以上感到滿意，這實際上是基於巨大的市場潛力、指導方針的進一步實施以及顯然是最近在亞洲的推出。這使我們達到了 50 億美元以上的大關，但作為內部指導，這是假設 2025 年的 LOE。

Thanks, Marie-France. Next question, operator.

謝謝，瑪麗-法蘭西。下一個問題，接線員。

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

您的下一個問題來自 Redburn 的 Simon Baker。

Question for Susanne on Lu-PSMA. I was wondering if you are pursuing on the diagnostics side, a technetium PSMA imaging kit. Because the feedback that we've had from radiologists over here is that there is a huge excitement in the U.K. about the PSMA. But there is some concern that its utility beyond large centers because of the need for gallium PSMA screening will make it harder to use more broadly. I just wondering if that's feedback you've seen elsewhere, if you're looking at using the much more easy-to-administer, if not quite so impressive technetium PSMA kit in order to broaden the number of centers that can practically use it.

Susanne 關於 Lu-PSMA 的問題。我想知道您是否正在追求診斷方面的锝 PSMA 成像套件。因為我們從放射科醫生那裡得到的反饋是，英國對 PSMA 感到非常興奮。但有人擔心，由於需要鎵 PSMA 篩查，它在大型中心以外的應用將使其更難更廣泛地使用。我只是想知道這是否是您在其他地方看到的反饋，如果您正在考慮使用更易於管理，如果不是那麼令人印象深刻的锝 PSMA 套件，以擴大可以實際使用它的中心的數量。

So thank you, Simon, for the question. So we have focused on gallium PSMA really to have this ready for launch. And we wanted to make sure that there is a diagnostic available. You see the other options also focus on gallium. And then I think there is quite a push for fluoride PSMA diagnostic as this is still, I would say, across the G7 markets, the most used diagnostics.

所以謝謝你，西蒙，這個問題。因此，我們一直專注於鎵 PSMA，以便為發射做好準備。我們想確保有可用的診斷。您會看到其他選項也關注鎵。然後我認為對氟化物 PSMA 診斷有很大的推動作用，因為我想說，在 G7 市場中，這仍然是最常用的診斷方法。

I think technetium is quite focused in the U.K. I didn't hear so much about that, ex U.K. And I mean, as we are targeting earlier lines of therapy, you have to see that we really have a diagnostic available that is very easily available and that's certainly the fluoride one. So that's what we are focusing on. And probably technetium is quite focused in the U.S. -- sorry, in the U.K.

我認為锝非常專注於英國我沒有聽到太多關於這個的消息，前英國我的意思是，由於我們針對的是早期的治療線，你必須看到我們確實有一個非常容易獲得的診斷那肯定是氟化物。所以這就是我們所關注的。而且锝可能非常集中在美國——對不起，在英國。

Thanks, Susanne. And I just wanted to take a step back. I have to clarify a comment I made to Graham's question. For NATALEE, we are collecting Ki-67. It's in about 70% to 80% of the total enrolled patients. It's part of the statistical analysis plan, but not a prespecified stratification factor.

謝謝，蘇珊。我只是想退後一步。我必須澄清我對格雷厄姆的問題所做的評論。對於 NATALEE，我們正在收集 Ki-67。大約有 70% 到 80% 的入組患者出現這種情況。它是統計分析計劃的一部分，但不是預先指定的分層因素。

So with that, we'll move to the next question.

因此，我們將轉到下一個問題。

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。

One on Leqvio please. Marie-France, kind of you spoke about the confidence in Leqvio launch and the preparedness for that going into 2022. Kind of the clarity around what you partnered with NHS in England still remains very kind of dim or very unclear. So just wondering if you can give us a bit more details on how we should think about the rollout of this molecule in the U.K.

請在 Leqvio 上一個。 Marie-France，您談到了對 Leqvio 推出的信心以及為進入 2022 年所做的準備。您與英國 NHS 合作的內容仍然非常模糊或不清楚。所以只是想知道你是否可以給我們更多關於我們應該如何考慮這種分子在英國推出的細節。

And then just in the same vein, I think consensus is looking at about $250 million in revenue for this drug next year. Do you think that appropriately reflects what you see as the launch dynamics for this? Or should we be thinking about something lower or higher than $250 million for like next year?

同樣，我認為共識是明年這種藥物的收入約為 2.5 億美元。您認為這是否恰當地反映了您認為的啟動動態？或者我們應該考慮像明年那樣低於或高於 2.5 億美元？

Marie-France?

瑪麗-法蘭西？

All right. So thanks for the question and the opportunity to talk about Leqvio. So on the U.K., first of all, we're very happy with the positive NICE approval and the commitment from the NHS to fund and treat 300,000 ASCVD patients. I think this provides solid proof that we can get the broad access prior to the outcomes data and based on the back of, obviously, solid evidence around LDL-C lowering.

好的。感謝您提出問題並有機會談論 Leqvio。因此，在英國，首先，我們對 NICE 的積極批准以及 NHS 承諾資助和治療 300,000 名 ASCVD 患者感到非常高興。我認為這提供了確鑿的證據，證明我們可以在結果數據之前獲得廣泛的訪問權，並且顯然基於降低 LDL-C 的確鑿證據。

So what we're doing right now in the U.K., and this is going to be the focus for the next couple of months, is really identify patients and work on the care pathways to reach 1,200 GP networks. It's early days, but we're doing -- we're having -- we're seeing really great progress around central funding, the digital patient IDs, the incentives for GPs and the educational programs. And the feedback from lipid specialists and GPs has also been very positive. So we expect a slow ramp in Q4. But you can expect to see some significant ramp-up in Q1 of next year for the U.K.

因此，我們現在在英國所做的，這將是未來幾個月的重點，真正識別患者並製定護理途徑，以達到 1,200 個 GP 網絡。現在還為時尚早，但我們正在做——我們正在做——我們看到圍繞中央資金、數字患者 ID、全科醫生的激勵措施和教育計劃取得了巨大的進步。脂質專家和全科醫生的反饋也非常積極。因此，我們預計第四季度將緩慢增長。但是你可以期待在明年第一季度看到英國的一些顯著增長。

If I then turn to the U.S. Again, here, we're focusing on the 200 systems of care. And as we said, we're also looking to build buy-and-bill. The first half of the year is going to be focused on our J-code, building up the buy-and-bill infrastructure, going through the P&T reviews and making sure that we're ready. And then you'll see that uptick towards the second half of the year. And the number you quoted, we feel extremely comfortable with that number for next year.

如果我再次轉向美國，在這裡，我們將重點放在 200 個護理系統上。正如我們所說，我們也在尋求建立購買和賬單。今年上半年將專注於我們的 J 代碼，建立購買和賬單基礎設施，通過 P&T 審查並確保我們已做好準備。然後你會看到下半年的上漲。你引用的數字，我們對明年的這個數字感到非常滿意。

Thanks, Marie-France. Next question, operator.

謝謝，瑪麗-法蘭西。下一個問題，接線員。

Your next question comes from the line of Seamus Fernandez from Guggenheim Securities.

您的下一個問題來自古根海姆證券公司的 Seamus Fernandez。

Great. Just a quick question. I noticed that your G12C agent moved into or is planned to move into Phase III. Can you just help us understand the data that prompted the planned advancement of the KRAS G12C inhibitor?

偉大的。只是一個快速的問題。我注意到您的 G12C 代理已進入或計劃進入第三階段。您能否幫助我們了解促使 KRAS G12C 抑製劑計劃推進的數據？

And then just as a follow-on to that, do you think this asset can differentiate meaningfully from other therapies on its own? Or is the differentiation really key to near-term development in combination with your SHP2 inhibitor.

然後，作為一個後續，您認為這項資產本身是否可以有意義地與其他療法區分開來？或者，與您的 SHP2 抑製劑相結合，差異化真的是近期開發的關鍵嗎？

Thanks, Seamus. I'll hand that to John. John?

謝謝，西莫。我會把它交給約翰。約翰？

Seamus, thanks for the question. And our KRAS G12C, which is JDQ433 in our program, we've advanced this molecule forward and plan to have Phase III in place by the first half of next year. What we've seen is really good PK/PD data and good tolerability by the patients. As we move forward, you'll be hearing more about this in the congresses next year.

Seamus，謝謝你的提問。而我們的 KRAS G12C，即我們計劃中的 JDQ433，我們已經推進了這種分子，併計劃在明年上半年實現 III 期。我們看到的是非常好的 PK/PD 數據和患者良好的耐受性。隨著我們向前發展，您將在明年的大會上聽到更多關於此的信息。

On your specific question about the strategy moving forward and differentiation versus the other KRAS G12Cs and potential marketplace and in the marketplace now, we think that the approach for KRAS G12C is really in combinations. What we've seen so far is that you are getting -- the durability is probably not as long as what we would like and that we're seeing mutations. And with those mutations, it will be a combination approach. And these combinations could be a number of factors, including our potential TNO SHP2 in our pipeline. You'll be hearing about that combination from our pipeline next year also.

關於您關於推進戰略和與其他 KRAS G12C 和潛在市場以及現在市場的差異化的具體問題，我們認為 KRAS G12C 的方法實際上是組合的。到目前為止，我們看到的是你得到了——持久性可能沒有我們想要的那麼長，而且我們看到了突變。有了這些突變，這將是一種組合方法。這些組合可能是許多因素，包括我們管道中潛在的 TNO SHP2。明年你也會從我們的管道中聽到這種組合。

Thanks, John.

謝謝，約翰。

Your next question comes from the line of Sarita Kapila from Morgan Stanley.

您的下一個問題來自摩根士丹利的 Sarita Kapila。

So if you could help us understand the rationale for taking your BTK inhibitor [very briefly] forward in CSU, especially when ligelizumab is being trialed in this setting also? And how are you thinking about positioning of the 2 assets relative to one another and also to [frataxin]?

因此，如果您能幫助我們了解在 CSU 中[非常簡要地] 推進您的 BTK 抑製劑的基本原理，尤其是當 ligelizumab 也在這種情況下進行試驗時？您如何考慮將 2 項資產相對於彼此以及與 [frataxin] 進行定位？

Thank you for the question. John?

感謝你的提問。約翰？

Yes. So remibrutinib, as you probably have seen, is highly our selective and potent covalent oral BTK inhibitor. We did do an extensive Phase II program in CSU, which was recently released. And what we saw is really good uptake, and the efficacy was extremely strong.

是的。因此，正如您可能已經看到的那樣，remibrutinib 是我們高度選擇性和有效的共價口服 BTK 抑製劑。我們確實在最近發布的 CSU 中進行了廣泛的 II 期計劃。而且我們看到的吸收真的很好，而且效果非常的強。

Now what we've seen is the efficacy was seen both at 4 weeks and at 12 weeks. And in addition to that, we saw efficacy very early at the 1-week time point. So really strong efficacy data, pin back on the safety profile, which as we think about BTK inhibitors, sometimes are saddled with LFTs, also cytopenias, and we did not see that in our overall program. So given our approach, we're very comfortable advancing CSU into our Phase III program.

現在我們看到的是在第 4 周和第 12 週時都看到了療效。除此之外，我們在 1 週的時間點很早就看到了療效。所以非常強大的功效數據，回到安全性，當我們考慮 BTK 抑製劑時，有時會背負 LFT，還有血細胞減少症，我們在整個項目中沒有看到這一點。因此，鑑於我們的方法，我們很樂意將 CSU 推進到我們的第三階段計劃。

Now one thing we should also note is ligelizumab, we've seen Phase II results, which were equally strong. And the approach that we're taking here is ligelizumab would be giving patients an opportunity at [Q4] week treatment with a subcu injection. And then remibrutinib would be an oral opportunity given the large, massive unmet need in CSU patient population. That's our overall approach.

現在我們還應該注意的一件事是 ligelizumab，我們已經看到了 II 期結果，它同樣強大。我們在這裡採用的方法是 ligelizumab 將在 [Q4] 週通過 subcu 注射為患者提供機會。鑑於 CSU 患者群體中大量未滿足的需求，瑞布替尼將成為一種口服機會。這是我們的總體方法。

And I think Marie-France could add a few more points. Marie-France?

我認為 Marie-France 可以再增加幾分。瑪麗-法蘭西？

Yes. So just maybe going back to the size of the market and the unmet need. So we know there are about 1.3 million CSU patients who are inadequately controlled in the top 11 markets. In fact, these patients are on antihistamines and steroids and really almost considered the sort of forgotten or unwanted patients. So we really want to make a difference in this space.

是的。因此，也許只是回到市場規模和未滿足的需求。所以我們知道，在前 11 個市場中，約有 130 萬 CSU 患者未得到充分控制。事實上，這些患者正在服用抗組胺藥和類固醇，幾乎被認為是那種被遺忘或不受歡迎的患者。所以我們真的想在這個領域有所作為。

Of course, we have a potentially strongly differentiated asset with ligelizumab and an opportunity to increase the biologic penetration. We also have a strong footprint, right, not only with dermatologists, but don't forget that we work with Xolair in the U.S. And so we have the strong relationships with allergists as well. And then bringing oral to market would really sort of complete the picture and make it perhaps an attractive first option post-antihistamine for CSU patients. So we're very excited about this space. We think we can build on the legacy that we've already built and make a real difference for these patients.

當然，我們擁有 ligelizumab 的潛在強大差異化資產，並有機會增加生物滲透。我們也有強大的足跡，對，不僅與皮膚科醫生合作，但不要忘記我們在美國與 Xolair 合作。因此我們也與過敏症專家建立了牢固的關係。然後將口服藥物推向市場將真正完成這幅畫，並使其成為 CSU 患者抗組胺藥後有吸引力的第一選擇。所以我們對這個空間感到非常興奮。我們認為我們可以在我們已經建立的遺產的基礎上再接再厲，為這些患者帶來真正的改變。

Thanks, Marie-France. Next question, operator.

謝謝，瑪麗-法蘭西。下一個問題，接線員。

Your next question comes from the line of Jo Walton from Credit Suisse.

您的下一個問題來自瑞士信貸的 Jo Walton。

I wonder if I could just go back to Sandoz, and if you could give us a little bit more detail on your biosimilar program. If we're going to be trying to value this, we'll have to really think about this in perhaps more detail than we do when we just look at Novartis on its own. So perhaps you could just tell us a little bit about where you think you're going to be particularly successful and give us some help as to see how we're going to get to $3 billion by -- your $3 billion sales target.

我想知道我是否可以直接回到 Sandoz，您是否可以向我們提供有關您的生物仿製藥計劃的更多細節。如果我們要嘗試重視這一點，我們將不得不真正考慮這一點，也許比我們只看諾華公司本身時所做的更詳細。所以也許你可以告訴我們一些你認為你會特別成功的地方，並給我們一些幫助，看看我們將如何達到 30 億美元——你的 30 億美元的銷售目標。

Thanks, Jo. I'll hand it over to Richard. Richard?

謝謝，喬。我會把它交給理查德。理查德?

Thank you, Jo. As you know, we don't normally disclose specific details of our programs. What I will say is we intend to launch 6 biosimilars in both the U.S. and Europe over the next few years, which will start rapidly accelerating our business. And currently, we have over 15 and expanding number of projects, both in-house developments or through partnership deals that we intend to launch in the coming years.

謝謝你，喬。如您所知，我們通常不會透露我們計劃的具體細節。我要說的是，我們打算在未來幾年內在美國和歐洲推出 6 種生物仿製藥，這將開始迅速加速我們的業務。目前，我們有超過 15 個且數量不斷增加的項目，無論是內部開發還是通過我們打算在未來幾年推出的合作交易。

So clearly, as we go through the process and at whatever time is appropriate, we'll give greater clarity in terms of the makeup of that. But obviously, it's relatively sensitive in terms of recent disclosure.

很明顯，當我們完成整個過程時，在任何適當的時候，我們都會更清楚地說明其構成。但顯然，就最近的披露而言，它相對敏感。

I think the only point I would add is I think Sandoz does its best to cover the major LOEs. I think there really is another wave of LOEs in this kind of '24 beyond standpoint in biologics. And with an increasing interest in the U.S. to enable biosimilars to fully participate, I think it's a tremendous opportunity for the Sandoz business.

我想我要補充的唯一一點是，我認為 Sandoz 盡最大努力涵蓋主要的 LOE。我認為在這種 24 年的生物製劑領域之外，確實還有另一波 LOE 浪潮。隨著美國對生物仿製藥全面參與的興趣日益濃厚，我認為這對 Sandoz 業務來說是一個巨大的機會。

Thanks, Jo. Next question, operator.

謝謝，喬。下一個問題，接線員。

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。

Just going on to Cosentyx. Obviously, last -- this year, we had some formulary disruptions, which you navigated very well. Maybe you could give us an idea how the discussions have gone for '22 and is that a normalization? Have you said that you can see volume growth coming through or managed to win back any positioning?

只是去Cosentyx。顯然，去年 - 今年，我們有一些處方中斷，你很好地駕馭了。也許你可以告訴我們 22 年的討論是如何進行的，這是一種正常化嗎？您是否說過您可以看到銷量增長或成功贏回任何定位？

Thanks, Richard. Marie-France?

謝謝，理查德。瑪麗-法蘭西？

So thank you, Richard. So you're absolutely right. In the U.S., we've seen strong value growth versus previous year due to this access change. What we have seen now in Q3 is quarter-over-quarter volume growth, and that's in line with the market. So we do expect volume growth to be the growth driver in the U.S. for 2022. We also expect our access position to stay stable. And we do believe that most major key payers will have us on formulary.

所以謝謝你，理查德。所以你是絕對正確的。在美國，由於這種訪問方式的變化，我們看到了與去年相比強勁的價值增長。我們現在在第三季度看到的是環比增長，這與市場一致。因此，我們確實預計銷量增長將成為 2022 年美國的增長動力。我們還預計我們的准入地位將保持穩定。而且我們確實相信，大多數主要的主要付款人都會將我們列入處方集。

So ultimately, what we need to do in the U.S. next year is really focus on our strengths, which is our existing markets. I talked about the focus on the PSO/PSA comorbid patients. There are 2/3 of the patients that have additional manifestations. And we have a really broad body of evidence in this space, the axial SpA patients. And then, of course, preparing for IV, which could be a significant opportunity in the U.S. 14% to 18% of these patients are on medical benefit for PSA. And then, of course, our hidradenitis suppurativa, 220,000 patients in the U.S., so significant opportunities to prepare for in 2023.

所以最終，我們明年在美國需要做的是真正關注我們的優勢，也就是我們現有的市場。我談到了對 PSO/PSA 合併症患者的關注。有 2/3 的患者有其他表現。我們在這個領域擁有非常廣泛的證據，即軸向 SpA 患者。然後，當然，為靜脈注射做準備，這在美國可能是一個重要的機會。這些患者中有 14% 到 18% 的患者正在接受 PSA 的醫療福利。然後，當然，我們的化膿性汗腺炎，美國有 220,000 名患者，為 2023 年做好準備的重要機會。

Thanks, Marie-France. Next question, operator.

謝謝，瑪麗-法蘭西。下一個問題，接線員。

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

您的下一個問題來自 Exane BNP Paribas 的 Richard Parkes。

It's just on business development and M&A, you've been relatively quiet this year. So I'm just wondering if you could talk about your appetite for M&A based on opportunities out there and valuations and maybe thoughts on capital allocation if there weren't sort of near-term opportunities and thinking about buyback and when a decision might be made on that.

只是在業務發展和併購方面，今年你相對安靜。所以我只是想知道你是否可以根據那裡的機會和估值談論你對併購的興趣，如果沒有近期機會和考慮回購以及何時可能做出決定，也許還有對資本配置的想法在那。

Thanks, Richard. Harry?

謝謝，理查德。哈利？

Yes. Richard, overall, we remain with our capital allocation priorities as we always laid out, investment in the organic business, growing dividend, as you have seen in March coming in over $7 billion. And then, of course, bolt-on M&A and in-licensing where we did the in-license of tislelizumab for $650 million. And we have continuously, of course, screen the market, and we continue to look opportunistically for bolt-on M&A opportunities that fit our franchises and existing infrastructures, if you will. But of course, they won't happen every year. Therefore, that's why we say, up to. And from that standpoint, not a formula. But we continue to be basically on that path.

是的。理查德，總的來說，我們仍然按照我們一直制定的資本分配優先事項，對有機業務進行投資，增加股息，正如你在 3 月份看到的那樣，收入超過 70 億美元。然後，當然是補強併購和許可，我們以 6.5 億美元的價格獲得了 tislelizumab 的許可。當然，我們一直在篩選市場，如果您願意的話，我們會繼續尋找適合我們特許經營權和現有基礎設施的附加併購機會。但當然，它們不會每年都發生。因此，這就是為什麼我們說，最多。從這個角度來看，不是一個公式。但我們基本上繼續走在這條道路上。

And then from a share buyback standpoint, as you know, we always buy back the employee participation program as we did this year to never dilute our shareholders. And we finished in the first half, a $2.5 billion program that we announced end of last year. So we're working along those lines on our capital allocation, and no change in our M&A and BD strategy.

然後從股票回購的角度來看，如您所知，我們總是像今年一樣回購員工參與計劃，以免稀釋我們的股東。我們在上半年完成了一項我們去年底宣布的 25 億美元的計劃。因此，我們正在沿著這些路線進行資本分配，並且我們的併購和 BD 戰略沒有改變。

Thanks, Harry. Next question, operator.

謝謝，哈利。下一個問題，接線員。

Your next question comes from the line of Naresh Chouhan from Intron Health.

您的下一個問題來自 Intron Health 的 Naresh Chouhan。

Just one on Sandoz, please. You mentioned that Sandoz was more integrated into Novartis than Alcon was. It would be really helpful if you could quantify the size of these synergies in fully separating Sandoz out to allow us to kind of value any value creation from a separation or a sale?

請在 Sandoz 上提供一個。你提到山德士比愛爾康更能融入諾華。如果您能夠量化這些協同效應的規模，將 Sandoz 完全分離出來，讓我們能夠從分離或出售中評估任何價值創造，那將是非常有幫助的？

Harry?

哈利？

Yes. Naresh, that's, of course, what a strategic review will inform us about. And that's why we take some time to do that very thoroughly. And there are -- I would say, there are 2 components to this. Also if I compare this to the Alcon situation, as we analyzed, and of course, no decision made at all. So it could also be the decision of retaining.

是的。 Naresh，當然，這就是戰略審查將告知我們的內容。這就是為什麼我們需要一些時間來非常徹底地做到這一點。還有——我想說，這有兩個組成部分。另外，如果我將其與我們分析的愛爾康情況進行比較，當然，根本沒有做出任何決定。所以它也可能是保留的決定。

But also in the case of the separation, I would say it's probably a bit easier at the moment because Richard and Steffen Lang and our technical operations team and the Sandoz team are focused on making the manufacturing and supply chain as autonomous as possible over the last 2, 3 years. And that basically has been completed and within Novartis. So there, we are probably ahead of where we were when we announced Alcon.

但在分離的情況下，我想說目前可能更容易一些，因為 Richard 和 Steffen Lang 以及我們的技術運營團隊和 Sandoz 團隊過去一直專注於使製造和供應鏈盡可能自主2、3年。這基本上已經在諾華內部完成。所以在那裡，我們可能領先於我們宣布愛爾康時的位置。

On the other hand, of course, the business has been built over 20 years plus with acquisitions and system-wise fully integrated, where Alcon probably was a bit more separate as it was shorter with the company. So we have a couple of head tailwinds, but that's why doing such reviews takes that time and we indicate that in a good year, we will give an update. If things go a bit faster, we come earlier, but this is operationally complex. And of course, we have to exactly figure out synergies, dissynergies, potential standup costs, tax considerations as well as separation costs.

另一方面，當然，該業務已經建立了 20 多年，加上收購和系統方面的完全集成，愛爾康可能更加獨立，因為它與公司的時間較短。因此，我們有一些不利因素，但這就是為什麼進行此類審查需要花費時間，我們表示，在好的一年，我們將提供更新。如果事情進展得快一點，我們就會來得更早，但這在操作上很複雜。當然，我們必須準確地計算出協同效應、非協同效應、潛在的站立成本、稅收考慮以及分離成本。

Thanks, Harry. Thanks so much for the question. Next question, operator.

謝謝，哈利。非常感謝這個問題。下一個問題，接線員。

Your next question comes from the line of Florent Cespedes from SocGen.

您的下一個問題來自法國興業銀行的 Florent Cespedes。

A quick one on asciminib. Was just wondering if you could elaborate a bit on your strategy in first-line because you are just starting the clinical program, how you will profit this product versus the pretty good already existing drugs.

關於 asciminib 的快速介紹。只是想知道您是否可以詳細說明您的一線策略，因為您剛剛開始臨床計劃，與現有的相當不錯的藥物相比，您將如何從該產品中獲利。

Susanne?

蘇珊？

Yes. Thank you, Florent. As you heard us, we are quite excited about asciminib, to get this prepared for launch in third line. As you show, we saw remarkable results versus bosutinib in this setting, which tells us that this mechanism of action is very effective. And we know from medical experts and patients that there is still high need in first-line. CML patients really are on a lifelong treatment. And we know that if you have a fast and deep molecular response early on, this could even lead to a treatment-free period, and that's what really experts are aiming for.

是的。謝謝你，弗洛倫特。正如您所聽到的那樣，我們對 asciminib 感到非常興奮，為在第三線推出做好準備。正如您所展示的，我們在這種情況下看到了與博舒替尼相比的顯著結果，這告訴我們這種作用機制非常有效。我們從醫學專家和患者那裡了解到，一線的需求仍然很大。 CML 患者確實在接受終身治療。而且我們知道，如果您早期有快速而深入的分子反應，這甚至可能導致無治療期，而這正是專家們的目標。

So there is the desire to be even better in first line. And the approach that we take is really to compare it to different TKIs. That's why we allow investigator-selected the TKI so that we have a broad range of comparator products. And then we have to see -- the focus certainly is then on the deep molecular response. And if we can prove that, certainly, that really has significant potential. So that's the strategy we're pursuing for asciminib in early lines.

因此，人們希望在一線做得更好。我們採用的方法實際上是將其與不同的 TKI 進行比較。這就是為什麼我們允許研究者選擇 TKI，以便我們擁有廣泛的比較產品。然後我們必須看到——重點肯定是在深層分子反應上。如果我們能證明這一點，當然，這確實具有巨大的潛力。這就是我們在早期產品線中為 asciminib 所追求的策略。

Perfect. Thanks, Susanne. Thanks, Florent. Next question, operator.

完美的。謝謝，蘇珊。謝謝，弗洛倫特。下一個問題，接線員。

Your next question comes from the line of Tim Anderson from Wolfe Research.

您的下一個問題來自 Wolfe Research 的 Tim Anderson。

This is Richard Wagner with Wolfe Research on behalf of Tim. A question on Sandoz, please. How does Novartis avoid a situation similar to Pfizer's Upjohn spin where they divest a lower multiple business? Now when analysts did a sum of the parts analysis, ended up with a figure that basically suggested the spin was destroying value because the multiple in the Upjohn business was lower than that was put on the parent Pfizer company. The Sandoz spin could end up causing the same thing to us because generic multiples are pretty much always lower than pharma company multiples. So how can Novartis mitigate this?

我是代表 Tim 的 Wolfe Research 的 Richard Wagner。請向 Sandoz 提問。諾華如何避免類似于輝瑞的 Upjohn 剝離的情況，即剝離較低倍數的業務？現在，當分析師對零件進行匯總分析時，最終得到的數字基本上表明這種旋轉正在破壞價值，因為 Upjohn 業務的倍數低於母公司輝瑞公司的倍數。山德士的自旋最終可能會給我們帶來同樣的結果，因為仿製藥的倍數幾乎總是低於製藥公司的倍數。那麼諾華如何緩解這種情況呢？

Yes. Thanks, Richard. So first and foremost, I think we're focused on building a strong business with clear sales growth outlook, strong margin outlook, that can be a leading global generics player. I'd also note that when you look in the generic sector, you see a wide range of multiples when you look at specialty generics players, players that are more exposed to Europe or Asia versus players more exposed to the U.S. And so that's all of the work we need to do to really understand what is the best way to maximize value for our shareholders as well as enable Sandoz to be as successful as possible.

是的。謝謝，理查德。因此，首先，我認為我們專注於建立強大的業務，具有明確的銷售增長前景和強勁的利潤率前景，可以成為全球領先的仿製藥企業。我還要指出，當您查看仿製藥行業時，當您查看專業仿製藥公司時，您會看到範圍廣泛的倍數，更多接觸歐洲或亞洲的公司與更多接觸美國的公司這就是全部我們需要做的工作才能真正了解為我們的股東實現價值最大化以及使山德士盡可能成功的最佳方式。

And we have a range, I think, of different options we can look at and as Harry rightly pointed out, including retaining the business. So I don't see it as an analogous situation, especially given that Sandoz is the #1 generics player in Europe, the #1 global antibiotics player in the industry and the #1 biosimilar company globally and sales primarily driven by ex-U.S. business.

我認為，我們有一系列不同的選擇，正如哈利正確指出的那樣，包括保留業務。所以我不認為這是一個類似的情況，特別是考慮到山德士是歐洲排名第一的仿製藥廠商、行業排名第一的全球抗生素廠商和全球排名第一的生物仿製藥公司，並且銷售主要由美國以外地區推動。商業。

So relatively low U.S. exposure, which, in our view, is what drives the lower multiples of some of the peers. So that's kind of our perspective at the moment. And we'll, of course, update it as we do the assessment.

美國的風險敞口相對較低，在我們看來，這是導致一些同行較低倍數的原因。這就是我們目前的觀點。當然，我們會在評估時對其進行更新。

Thanks a lot, Richard, for the question. Next question, operator.

非常感謝理查德，這個問題。下一個問題，接線員。

Your next question comes from the line of Wimal Kapadia from Bernstein.

您的下一個問題來自 Bernstein 的 Wimal Kapadia。

Wimal?

維馬爾？

Apologies. It looks like the line has disconnected. So we'll go on to your next question, which comes from the line of Simon Baker from Redburn.

道歉。好像線路斷了。因此，我們將繼續您的下一個問題，該問題來自 Redburn 的 Simon Baker。

Simon? All right. Next one, operator?

西蒙？好的。下一位，接線員？

One moment. It looks like I've opened Simon Baker's line.

一瞬間。看起來我已經打開了西蒙貝克的線路。

Hello, can you hear me?

你好，你能聽到我說話嗎？

Yes, we can hear you, Simon. Thank you.

是的，我們可以聽到你的聲音，西蒙。謝謝你。

Excellent, excellent. Yes. A quick question for Harry, just following up on the subject of the buyback. Could you just remind us what your buyback mandate capacity left is? Because I noticed that this is the first Q3 for about 8 years when you haven't bought back any stock. So just a reminder on what your left able to buy would be great.

優秀的，優秀的。是的。哈利的一個快速問題，只是跟進回購的主題。您能否提醒我們您剩餘的回購授權能力是多少？因為我注意到這是大約 8 年來的第一個第三季度，當時你還沒有回購任何股票。因此，只需提醒您左手可以購買的東西就會很棒。

Harry?

哈利？

Yes. Thank you very much, Simon. So overall, we pretty much, I think, close to our authority from the AGM, but we do usually do a renewal of it. But overall, when you look over the last years, we have consistently done like -- it's not a formula, again, but roughly $2.5 billion per year or $5 billion every 2 years. Again, not a formula. It completely has to do with what opportunities do we have basically on M&A and on bolt-on M&A.

是的。非常感謝你，西蒙。所以總的來說，我認為，我們幾乎接近年度股東大會的權威，但我們通常會更新它。但總的來說，當你回顧過去幾年時，我們一直在這樣做——這又不是一個公式，而是每年大約 25 億美元或每 2 年 50 億美元。同樣，不是公式。這完全與我們基本上在併購和補強併購方面擁有哪些機會有關。

And then, of course, so from a capital allocation standpoint, the first 3 priorities are worked through and then, of course, in terms of where the share price is. But it's not only a question of share price, of course, also capital allocation priorities. And we just finished one. So from that standpoint, at this moment, we have not announced an additional one.

然後，當然，從資本配置的角度來看，前三個優先事項已經完成，當然，還有股價在哪裡。但這不僅是股價問題，當然也是資本配置的優先事項。我們剛剛完成了一個。所以從這個角度來看，目前，我們還沒有宣布增加一個。

Thanks, Harry. Next question, operator.

謝謝，哈利。下一個問題，接線員。

You have a further question from the line of Graham Parry from Bank of America.

美國銀行的格雷厄姆帕里還有一個問題。

And this was on remibrutinib. I just wondered what data, if any, you have on CNS tissue for remibrutinib. And if you have any brain penetration with it, any evidence of any effect on microglial cells, so that's something which Sanofi obviously talks about with tolebrutinib quite a lot.

這是關於瑞布替尼的。我只是想知道你有哪些關於瑞布替尼的 CNS 組織數據（如果有的話）。如果你對它有任何大腦滲透，任何對小膠質細胞有任何影響的證據，那麼這就是賽諾菲顯然與托萊布替尼談論很多的事情。

Thanks, Graham. John?

謝謝，格雷厄姆。約翰？

Yes. Thanks, Graham. We have done some preclinical studies in this area. We have seen CNS penetration. In this early stage, what we don't know is exactly what the extent of the clinical validation and the clinical correlation in the central -- when you actually have central activation in these areas. So given that, what we're confident of overall in remibrutinib is that it's a very clean profile asset, as I've stated earlier, in terms of potency and selectivity. So we look forward to sharing some of these preclinical data as well as the overall clinical profile for remibrutinib.

是的。謝謝，格雷厄姆。我們在這方面做了一些臨床前研究。我們已經看到 CNS 滲透。在這個早期階段，我們不知道中樞的臨床驗證程度和臨床相關性究竟有多大——當你在這些區域中真正有中樞激活時。因此，鑑於此，我們對 remibrutinib 的整體信心是，正如我之前所說，就效力和選擇性而言，它是一種非常乾淨的資產。因此，我們期待分享其中一些臨床前數據以及瑞布替尼的整體臨床概況。

Thanks, John. Next question, operator.

謝謝，約翰。下一個問題，接線員。

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。

Maybe some -- back of the queue, take a couple. So one, the AveXis pipeline in neuroscience. It's been a somewhat slow story since the deal announced the setback in Rett syndrome today. If you could just give us a bit more color on that? Was that safety or efficacy related? That would be very helpful. And next steps? I think we were anticipating clinical development in Friedreich's and ALS by now, but I don't think you've announced anything to date.

也許有一些—— 在隊列後面，拿幾個。第一，神經科學中的 AveXis 管道。自從這筆交易今天宣布雷特綜合症受挫以來，這是一個有點緩慢的故事。如果你能給我們更多的顏色呢？這與安全性或有效性有關嗎？那將非常有幫助。接下來的步驟？我想我們現在已經在期待 Friedreich 和 ALS 的臨床開發了，但我認為你迄今為止還沒有宣布任何事情。

And then maybe the second question, if I may, just the shape of '22 looks pretty similar to '21 for you, following LOE thereafter. So I'm thinking low mid-single-digit sales growth with some margin improvement. Perhaps you could give us some initial thoughts on why that statement might be wrong, in particular, heads and tailwinds for next year would be helpful.

然後也許是第二個問題，如果可以的話，只是 '22 的形狀對你來說看起來與 '21 非常相似，之後是 LOE。因此，我認為銷售增長中位數較低，利潤率有所提高。也許你可以給我們一些初步的想法，說明為什麼該陳述可能是錯誤的，特別是明年的正面和順風會有所幫助。

Yes. So thanks, Emmanuel. First, on our gene therapy pipeline. First, we have a number of targets that are progressing right now in the clinic, I mean with the intrathecal now entering into Phase III. We have a number of ophthalmology programs in the recent optogenetics acquisition.

是的。所以謝謝，伊曼紐爾。首先，關於我們的基因治療管道。首先，我們有一些目前在臨床上取得進展的目標，我的意思是鞘內註射現在進入 III 期。在最近的光遺傳學收購中，我們有許多眼科項目。

With some of our neuroscience assets, we've decided to optimize our program to ensure that we really get, I think the optimal capsid as well as insert combination that will enable us to maximize efficacy. We've done extensive profiling work now, and we think that's the prudent course. It doesn't change our commitment to Rett syndrome, Friedreich's ataxia. And behind that, we have a number of other programs advancing in monogenic as well as polygenic neurological diseases.

憑藉我們的一些神經科學資產，我們決定優化我們的計劃，以確保我們真正獲得，我認為最佳衣殼和插入組合將使我們能夠最大限度地提高療效。我們現在已經完成了廣泛的分析工作，我們認為這是謹慎的做法。它不會改變我們對雷特綜合症（弗里德賴希的共濟失調）的承諾。在此之後，我們還有許多其他項目在單基因和多基因神經系統疾病方面取得進展。

So as with this field, we're always learning, and this is the case where we learn something more in our preclinical work, and it's making us just take a pause and optimize the program. And then we hope to move that quickly again into the clinic. Clearly, these patients need better therapies.

因此，與這個領域一樣，我們一直在學習，在這種情況下，我們在臨床前工作中學到了更多東西，這讓我們只需暫停一下並優化程序。然後我們希望盡快將其轉移到診所。顯然，這些患者需要更好的治療。

In terms of the shape of '22, it's really, of course, premature for us to comment, but maybe Harry could provide any perspective.

就 22 年的形式而言，當然，我們現在評論還為時過早，但也許哈利可以提供任何觀點。

Yes. As always, we have the tradition of guiding for next year with our full year results, end of January. And overall, on the margin progression -- on the margin progression, if that was part of the question, I would expect basically incremental continued improvement over the next years so that we do expect basically sales growth, of course, of next year, as Vas has laid out with a 4% CAGR roughly. And with that incremental margin improvement, after we have improved the margin almost 300 basis points last year, you see another margin improvement this year. But of course, last year was also due to the almost inability to partly promote given the pandemic situation.

是的。與往常一樣，我們有指導明年一月底全年業績的傳統。總體而言，關於利潤率增長——關於利潤率增長，如果這是問題的一部分，我預計未來幾年基本上會持續改善，因此我們確實預計明年的銷售額基本上會增長，因為Vas 的複合年增長率約為 4%。隨著利潤率的逐步提高，在我們去年將利潤率提高了近 300 個基點之後，您會看到今年的利潤率再次提高。但當然，去年也是由於大流行情況下幾乎無法部分推廣。

And on top of that, we have now further improved with excellent productivity programs, resource allocation and overall, of course, cost consciousness and changing the way we run the company in a more efficient way, taking full advantage of virtual opportunities.

最重要的是，我們現在通過出色的生產力計劃、資源分配以及整體成本意識以及改變我們以更有效的方式運營公司的方式，充分利用虛擬機會，進一步改進。

Thank you, Emmanuel. Next question, operator.

謝謝你，伊曼紐爾。下一個問題，接線員。

Your next question comes from the line of Jo Walton from Credit Suisse.

您的下一個問題來自瑞士信貸的 Jo Walton。

I just wondering if you could talk a little bit more about your enthusiasm in CAR-T. So the current generation haven't done so well. Now you're bringing a new one in. What's going to be so different? And have you sort of solved the problem whereby older people's blood can actually be more effectively manipulated and just have more successful and perhaps faster treatment?

我只是想知道你能否多談談你對 CAR-T 的熱情。所以現在這一代的表現並不好。現在你要引進一個新的。會有什麼不同？您是否已經解決了老年人血液實際上可以更有效地操縱並獲得更成功甚至更快的治療的問題？

Thanks, Jo. We've -- our teams have done a lot of work, and we've learned a lot since 2015 when we entered this space. We continue to believe that CAR therapy, cell therapies have a transformational benefit when successfully delivered, as you've seen in the patient populations that are currently licensed and have a tremendous potential.

謝謝，喬。我們已經 - 我們的團隊做了很多工作，自 2015 年進入這個領域以來，我們學到了很多東西。我們仍然相信 CAR 療法和細胞療法在成功交付後具有轉化優勢，正如您在目前獲得許可並具有巨大潛力的患者群體中看到的那樣。

So we invest in the -- a new approach, which we believe can optimize our cost of goods importantly, which enables us to make a much stronger financial return; optimizes our speed of production, which enables us to flexibilize production, increase scale; but most importantly, hopefully, can generate more durable and deep responses for these patients, so that we get higher ORRs or CRs as is relevant.

因此，我們投資了一種新方法，我們認為這可以優化我們的商品成本，重要的是，它使我們能夠獲得更強勁的財務回報；優化我們的生產速度，使我們能夠靈活生產，擴大規模；但最重要的是，希望能夠為這些患者產生更持久和更深入的反應，以便我們獲得更高的 ORR 或 CR。

And we believe that -- continue to believe that autologous approaches versus allo approaches are the best way to do that. I think our NIBR scientists have done an outstanding job. And we'll at least present the first set of data at ASH, and then we'll move forward from there. But I think it's worth remembering we have a global footprint in cell therapies, a global capability, and we have the ability given our financial firepower to stay the course and really try to be a long-term industry leader.

我們相信 - 繼續相信自體方法與allo方法是最好的方法。我認為我們的 NIBR 科學家做得非常出色。我們至少會在 ASH 上展示第一組數據，然後我們會從那裡繼續前進。但我認為值得記住的是，我們在細胞療法方面擁有全球足跡，擁有全球能力，並且憑藉我們的財務實力，我們有能力堅持到底，並真正努力成為長期的行業領導者。

Your next question comes from the line of Stefan Schneider from [Global].

您的下一個問題來自 [Global] 的 Stefan Schneider。

What kind of cough-cold season is captured in your full year guidance? And maybe in this context, for quarter 4, you're right, could start to return to pre-COVID levels in several markets. Can you specify that a bit further, so what several markets do you think of?

您的全年指導中捕捉到了什麼樣的咳嗽寒冷季節？也許在這種情況下，您是對的，第 4 季度可能會開始在幾個市場恢復到 COVID 之前的水平。您能否再具體說明一下，那麼您認為有哪些市場？

Richard, on the cough and cold?

理查德，咳嗽和感冒？

Thank you, Stefan. In our guidance, we've assumed, I guess, a more normal cough and cold season in line with previous seasons. So we've not assumed an exceptional one, but we assumed it in line with previous years. It's worth noting that the previous cough and cold season was pretty much nonexistent due to social distancing and mask wearing. But we're seeing that normalizing, a pickup in demand of our anti-infectors business as well as our OTC businesses, certainly in Europe and in other markets.

謝謝你，斯特凡。我猜，在我們的指導中，我們假設咳嗽和感冒季節與前幾個季節一樣正常。所以我們沒有假設一個例外，但我們假設它與前幾年一致。值得注意的是，由於社交距離和戴口罩，之前的咳嗽和感冒季節幾乎不存在。但我們看到這種正常化，我們的抗感染藥物業務以及我們的非處方藥業務的需求正在回升，當然在歐洲和其他市場也是如此。

Great. Thanks, Richard. And I believe we have one last question, operator.

偉大的。謝謝，理查德。我相信我們還有最後一個問題，接線員。

Your final question comes from the line of Wimal Kapadia from Bernstein.

您的最後一個問題來自 Bernstein 的 Wimal Kapadia。

Great. I believe somebody already asked on the microglial so can I just ask on Kisqali, please? And just a feedback post MONALEESA-2 OS benefit. Are you really seeing any increased appetite to use the drug versus the other CDK4/6s? And what is your base assumption of the share that you can now capture in the metastatic setting longer term? Will this data actually change dynamics? Just looking at the volume trends in the U.S., it really seems like relatively modest expansion in share so far. So how should we think about the next few years?

偉大的。我相信有人已經問過小膠質細胞了，所以我可以問一下 Kisqali 嗎？並且只是反饋發布 MONALEESA-2 操作系統的好處。與其他 CDK4/6 相比，您真的看到使用該藥物的胃口增加了嗎？您現在可以在長期轉移環境中獲得的份額的基本假設是什麼？這些數據真的會改變動態嗎？單看美國的銷量趨勢，到目前為止，市場份額的增長似乎相對溫和。那麼我們應該如何看待未來幾年呢？

Thanks, Wimal. Susanne?

謝謝，維馬爾。蘇珊？

Yes. Thank you for the question. I mean as you rightly say, the MONALEESA-2 data is certainly the biggest segment where we now also could demonstrate OS data. And we really hear feedback from medical experts that these are quite impressive data and confirms that there is something differentiated about Kisqali.

是的。感謝你的提問。我的意思是你說得對，MONALEESA-2 數據肯定是我們現在也可以展示操作系統數據的最大部分。我們確實聽到了醫學專家的反饋，這些數據令人印象深刻，並證實了 Kisqali 有一些不同之處。

So as I said, the last weeks, we see increased demand also in the U.S. And we keep focused on really delivering this method, working on getting this education story through. And we're also quite encouraged that now with COVID getting more normalized, that more patients start because that is, of course, certainly what was kind of hindering that, with less patients getting new treatment initiations. There was also less opportunity to grow.

所以正如我所說，過去幾週，我們看到美國的需求也在增加。我們一直專注於真正提供這種方法，努力讓這個教育故事通過。我們也非常鼓舞的是，現在隨著 COVID 變得更加正常化，更多的患者開始治療，因為這當然是阻礙這一點的原因，更少的患者開始接受新的治療。成長的機會也更少。

So we remain confident in Kisqali. We will focus on educating. And I believe Kisqali is the best differentiated OS or CDK4/6 with strong OS. And therefore, we believe we have the confidence for Kisqali to remain a significant growth driver.

因此，我們對 Kisqali 仍然充滿信心。我們將專注於教育。而且我相信 Kisqali 是最好的差異化操作系統或具有強大操作系統的 CDK4/6。因此，我們相信我們有信心讓 Kisqali 繼續成為重要的增長動力。

Thank, Susanne. And then Harry just had one quick correction.

謝謝，蘇珊。然後哈利只是快速更正了一下。

Yes. I just looked at our remaining share buyback program. So as we just renewed it recently, it's roughly $8.5 billion. So we have room, but again, no plans at the moment.

是的。我剛剛查看了我們剩餘的股票回購計劃。因此，正如我們最近更新的那樣，它大約是 85 億美元。所以我們有空間，但同樣，目前沒有計劃。

So to be clear, that's the $8.5 billion authorization from the AGM, but no plans at the moment.

需要明確的是，這是年度股東大會授權的 85 億美元，但目前沒有計劃。

So with that, we can close the call. Thank you all very much for joining. We look forward to you joining us on December 2, our R&D day, where we'll have our R&D leaders walking through the pipeline, giving you relevant details, hopefully getting your understanding up and hopefully excitement up on our mid- and early-stage pipeline. Look forward to that discussion.

因此，我們可以關閉通話。非常感謝大家的加入。我們期待您在 12 月 2 日（我們的研發日）加入我們，屆時我們的研發負責人將在管道中走來走去，為您提供相關細節，希望讓您了解並希望對我們的中期和早期階段感到興奮管道。期待那次討論。

In the meantime, I wish you all very well. Thank you again.

與此同時，我祝你們一切順利。再次感謝你。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。