Novartis AG (NVS) 2021 Q2 法說會逐字稿

Good morning and good afternoon, and welcome to the Novartis Q2 2021 Results Release Conference Call and Live Webcast.

早上好，下午好，歡迎來到諾華 2021 年第二季度業績電話會議和網絡直播。

(Operator Instructions) The conference is being recorded.

（操作員說明）正在錄製會議。

(Operator Instructions).

（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.

電話會議的錄音，包括問答環節，將在電話會議結束後不久在我們的網站上提供。

(Operator Instructions)

（操作員說明）

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

至此，我想向投資者關係全球主管 Samir Shah 先生匯報。

Please go ahead, sir.

請繼續，先生。

Thank you very much, and good morning and good afternoon, everybody.

非常感謝大家，大家早上好，下午好。

Big thank you to all of you, again, for participating in this call and spending the time to listen to our quarterly results.

再次感謝你們所有人參與本次電話會議並花時間聆聽我們的季度業績。

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

今天提供的信息包含涉及已知和未知風險、不確定性和其他因素的前瞻性陳述。

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

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

For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K that, respectively, were filed with and furnished to the U.S. Securities and Exchange Commission.

有關其中一些因素的描述，請參閱公司的 20-F 表格及其最近的 6-K 表格季度業績，這些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。

So thank you again.

所以再次感謝你。

And with that, I'll hand across to Vas Narasimhan.

有了這個，我將交給 Vas Narasimhan。

Thank you, Samir.

謝謝你，薩米爾。

And thanks, everyone, for joining today's conference call.

感謝大家參加今天的電話會議。

Today with me, I have members of our executive team.

今天和我在一起，我有我們執行團隊的成員。

And I also would like to introduce Karen Hale, our new Chief Legal Officer.

我還想介紹一下我們新任首席法務官 Karen Hale。

Karen joins us from the biopharmaceutical industry with over 20 years experience in a broad range of medical devices and pharmaceuticals.

Karen 從生物製藥行業加入我們，在廣泛的醫療器械和藥品領域擁有 20 多年的經驗。

So welcome, Karen.

所以歡迎，凱倫。

So if we can move to Slide 5. I wanted to start by reflecting on the journey we've been on as a company as we focused the company, rolled out our strategy, and delivered consistent performance over the recent period.

因此，如果我們可以轉到幻燈片 5。我想首先回顧一下我們作為一家公司所經歷的旅程，因為我們專注於公司，推出了我們的戰略，並在最近一段時間內提供了一致的業績。

Going back to the first half of 2018, when you look at our financial performance over the first half of the -- for the subsequent 4 years, our sales have grown at 6% CAGR, our core operating income at a 13% CAGR, and we've grown our Innovative Medicines margin from 31.8% to 36.8% in the first half of 2021, demonstrating that our operational execution has been strong.

回到 2018 年上半年，當您查看我們上半年的財務業績時——在接下來的 4 年中，我們的銷售額以 6% 的複合年增長率增長，我們的核心營業收入以 13% 的複合年增長率增長，以及到 2021 年上半年，我們的創新藥物利潤率從 31.8% 增長到 36.8%，這表明我們的運營執行力很強。

Now when you look ahead, we remain confident in our growth outlook, as we outlined in the Meet the Management last year, where we highlighted a 4% CAGR off of our 2019 actuals to a 2025 sales goal of $60 billion or more and a consensus IM margin that is currently at 37.6% that we remain confident that we can achieve.

現在，當您展望未來時，我們仍然對我們的增長前景充滿信心，正如我們在去年與管理層會面中概述的那樣，我們強調了 2019 年實際的 4% 的複合年增長率達到 600 億美元或更多的 2025 年銷售目標和共識IM 利潤率目前為 37.6%，我們仍然有信心實現這一目標。

So a strong performance track record and a strong growth outlook remains the story for Novartis.

因此，強勁的業績記錄和強勁的增長前景仍然是諾華的故事。

Now going to Slide 6. When you look at our strong performance in Q2, it was strong across all of the key elements that we believe will drive long-term value for patients as well as for shareholders.

現在轉到幻燈片 6。當您查看我們在第二季度的強勁表現時，我們認為所有關鍵要素都很強勁，我們認為這些要素將為患者和股東帶來長期價值。

Our sales growth was strong, and Harry will go through that in a bit more detail.

我們的銷售增長強勁，Harry 將更詳細地介紹這一點。

We had strong productivity with good core operating income growth and good margin expansion.

我們的生產力強勁，核心營業收入增長良好，利潤率擴張良好。

We continued our innovation agenda, which will be critical to driving the growth to 2025, and importantly, beyond.

我們繼續我們的創新議程，這對於推動到 2025 年的增長至關重要，更重要的是，超越。

And we also continued on our journey to be a leader in ESG with some important milestones.

我們還繼續我們的旅程，成為 ESG 的領導者，並取得了一些重要的里程碑。

And I'll talk about each of these areas in turn.

我將依次討論這些領域。

Moving to the next slide.

轉到下一張幻燈片。

When you look at our key growth drivers and launches over the period, we demonstrated, I think, strong performance across our key brands.

當您查看我們在此期間的主要增長動力和發佈時，我認為我們展示了我們主要品牌的強勁表現。

Marie-France will talk a bit more about the strong performance of Entresto, Cosentyx and Zolgensma, as well as Kesimpta, which is off to a good and strong start.

Marie-France 將更多地談論 Entresto、Cosentyx 和 Zolgensma 以及 Kesimpta 的強勁表現，這是一個良好而強勁的開端。

And then Susanne will also cover the various oncology growth drivers.

然後，Susanne 還將介紹各種腫瘤學增長驅動因素。

Now taken together, we -- our key growth drivers and launches now account for 51% of our IM sales.

現在綜合起來，我們的主要增長動力和發布現在占我們 IM 銷售額的 51%。

And these products are growing at a rate of 29% in quarter 2, which I think nicely demonstrates our transition from an older portfolio of medicines to a next wave of portfolios, which we believe will enable us to drive our growth over the next decade.

這些產品在第二季度以 29% 的速度增長，我認為這很好地證明了我們從舊的藥物組合過渡到下一波組合，我們相信這將使我們能夠在未來十年推動我們的增長。

Now moving to Slide 8. I also wanted to say a word on Sandoz.

現在轉到幻燈片 8。我還想談談 Sandoz。

We saw the business stabilize in quarter 2. We saw sales at 5% in the quarter.

我們看到第二季度的業務穩定。我們看到該季度的銷售額為 5%。

Biopharma sales were also up 5% and core operating income was also up.

生物製藥銷售額也增長了 5%，核心營業收入也增長了。

Now when you look at the story for the rest of the year for Sandoz, we continue to expect disruptions related to COVID, but we do expect also, assuming health care systems continue on their current trend, a return, hopefully, back to a more stable situation.

現在，當您查看 Sandoz 在今年餘下時間的故事時，我們繼續預計與 COVID 相關的中斷，但我們也確實預計，假設醫療保健系統繼續保持目前的趨勢，希望回歸到更多穩定的局面。

We have had a historically weak cough and cold season and decreased anti-infectives use, but we will see how this all unfolds.

我們經歷了歷史上較弱的咳嗽和感冒季節，抗感染藥的使用減少，但我們將看到這一切如何展開。

And again, we're hopeful that we can get back to a more stable situation overall in the generics sector.

再一次，我們希望我們可以在仿製藥領域恢復到更穩定的整體局面。

Now that said, we are confident in the longer-term outlook in Sandoz.

話雖如此，我們對山德士的長期前景充滿信心。

We've made the -- we believe, the right investments in biosimilars.

我們已經做出了——我們相信，對生物仿製藥的正確投資。

We've doubled the size of the biosimilars pipeline with a focus in key therapeutic areas such as oncology and immunology.

我們將生物仿製藥管道的規模擴大了一倍，重點放在腫瘤學和免疫學等關鍵治療領域。

And we continue to also invest in our core generics capabilities.

我們還將繼續投資於我們的核心仿製藥能力。

We strengthened our antibiotics manufacturing setup as well as brought in a new portfolio of assets, including our recent acquisition of GSK's anti-infectives portfolio.

我們加強了抗生素生產設置，並引入了新的資產組合，包括我們最近收購了葛蘭素史克的抗感染產品組合。

And we continue to make investments in complex generics, including oncology injectables and respiratory medicines.

我們繼續投資於復雜的仿製藥，包括腫瘤注射劑和呼吸系統藥物。

So over time, we remain committed to delivering a Sandoz outlook of mid-single-digit sales and mid- to high-20% core operating income margin.

因此，隨著時間的推移，我們將繼續致力於實現 Sandoz 中個位數銷售額和中高 20% 核心營業利潤率的前景。

So moving to the next slide and turning to innovation.

所以轉到下一張幻燈片並轉向創新。

Q2 continued progress on the innovation front.

第二季度在創新方面繼續取得進展。

We had approvals of Cosentyx in the U.S. in pediatric psoriasis, as well as Entresto in essential hypertension in China, which can be another growth driver for Entresto, building on its already strong performance.

我們在美國批准了 Cosentyx 治療小兒銀屑病，以及 Entresto 在中國治療原發性高血壓，這可能是 Entresto 的另一個增長動力，基於其已經強勁的表現。

I'll say a bit more on some of these other milestones in subsequent slides.

在隨後的幻燈片中，我將詳細介紹其中一些其他里程碑。

But I did want to note that asciminib, our ABL001, has been filed in the U.S. in the third-line setting.

但我確實想指出，我們的 ABL001 asciminib 已在美國以三線設置提交。

And we do believe this medicine has blockbuster potential in the third-line setting alone, not to mention our efforts to move it into earlier lines, which we'll say more about.

而且我們確實相信這種藥物僅在三線環境中就具有巨大的潛力，更不用說我們努力將其轉移到更早的線中，我們將對此進行更多說明。

And we also had important advances on Kymriah and apelisib as well, which I think will enable us to broaden the indications for both of these medicines.

我們在 Kymriah 和 apelisib 方面也取得了重要進展，我認為這將使我們能夠擴大這兩種藥物的適應症。

So moving to Slide 10 and taking a little bit of a deeper dive on our portfolio, starting with our life cycle management.

因此，轉到幻燈片 10，從我們的生命週期管理開始，對我們的產品組合進行更深入的研究。

I already mentioned the China approval in essential hypertension.

我已經提到中國對原發性高血壓的批准。

But in -- for Cosentyx, we remain on track for the hidradenitis suppurativa readouts in the second half.

但是在 - 對於 Cosentyx 來說，我們仍有望在下半年進行化膿性汗腺炎讀數。

There is strong open-label data that supports the use of Cosentyx in this indication.

有強大的開放標籤數據支持在該適應症中使用 Cosentyx。

And then we also have a range of other indications we're developing, as we've noted, to enable Cosentyx to continue its strong trajectory.

正如我們所指出的，我們還正在開發一系列其他跡象，以使 Cosentyx 能夠繼續其強勁的發展軌跡。

We're on track for Kisqali's MONALEESA-2 OS readout in the second half, which would be the third OS readout.

下半年，Kisqali 的 MONALEESA-2 操作系統讀數正在按計劃進行，這將是第三次操作系統讀數。

Two have already been favorable for Kisqali.

有兩個已經對基斯加利有利。

Really building on the unique profile we believe Kisqali has.

真正建立在我們認為 Kisqali 擁有的獨特形象之上。

We also are on track for the adjuvant readout in 2022.

我們也有望在 2022 年進行輔助讀數。

We'll speak more about Leqvio in a moment.

稍後我們將詳細討論 Leqvio。

Now turning to pharmaceuticals.

現在轉向藥品。

We'll go through iptacopan's data in a bit more detail.

我們將更詳細地介紹 iptacopan 的數據。

But I wanted to highlight as well that ligelizumab's CSU studies are on track for Phase III readout in the second half.

但我還想強調，ligelizumab 的 CSU 研究有望在下半年進行 III 期讀數。

We have also initiated on our progressing chronic inducible urticaria studies as well as food allergy studies.

我們還啟動了我們正在進行的慢性可誘發蕁麻疹研究以及食物過敏研究。

And we have continued to progress branaplam with an agreement now with the regulators for a start in the second half of a Phase IIb study in Huntington's disease.

我們繼續推進 branaplam，現在與監管機構達成協議，在亨廷頓病 IIb 期研究的下半年開始。

Moving to oncology.

轉向腫瘤學。

Our canakinumab readouts are also on track.

我們的 canakinumab 讀數也步入正軌。

For Lu-PSMA, we have submissions planned for the second half, and we've started the Phase III studies in the earlier line settings.

對於 Lu-PSMA，我們計劃在下半年提交，並且我們已經在較早的線路設置中開始了 III 期研究。

I'll say a bit more about that.

我會多說一點。

And I also wanted to highlight that, with TNO155, our SHP2 inhibitor, we've already now advanced both in combination with other KRAS agents, but are also now moving into the clinic with our SHP2 in combination with our own KRAS agent, JDQ, as well as other SHP2 combinations that we're currently exploring.

我還想強調的是，我們的 SHP2 抑製劑 TNO155 現在已經與其他 KRAS 藥物聯合使用取得了進展，但現在我們的 SHP2 與我們自己的 KRAS 藥物 JDQ 的組合也正在進入臨床，以及我們目前正在探索的其他 SHP2 組合。

Lastly, I wanted to note that asciminib now has entered our wildcard box on the bottom here in first-line setting, where asciminib is going against investigator choice of TKI.

最後，我想指出的是，asciminib 現在已經在第一行設置的底部輸入了我們的通配符框，其中 asciminib 與研究者選擇的 TKI 背道而馳。

Our hope is, if we were able to deliver this result, we would be able to once again transform the care of CML patients with a multi-blockbuster potential indication for asciminib.

我們的希望是，如果我們能夠實現這一結果，我們將能夠再次改變 CML 患者的護理方式，並為 asciminib 提供多重磅炸彈的潛在適應症。

It's worth noting that across the wildcards you see in that box, while these programs are still early, each one of them has the potential to be a multibillion-dollar medicine if we're ultimately able to deliver on the clinical value of these assets.

值得注意的是，在您在該框中看到的通配符中，雖然這些項目還處於早期階段，但如果我們最終能夠實現這些資產的臨床價值，它們中的每一個都有潛力成為價值數十億美元的藥物。

Now moving to Slide 11, saying a bit more on inclisiran.

現在轉到幻燈片 11，關於 inclisiran 的更多內容。

You likely saw that our PDUFA action date is now January 1, 2022.

您可能已經看到我們的 PDUFA 行動日期現在是 2022 年 1 月 1 日。

We have filed the -- refiled from our Schaftenau site, which is the manufacturing location where we currently do secondary manufacturing for products such as Cosentyx as well as other biologics.

我們已經提交了從我們的 Schaftenau 網站重新提交的文件，該網站是我們目前為 Cosentyx 和其他生物製劑等產品進行二次製造的製造地點。

So a site that's well known to the regulators.

因此，監管機構眾所周知的網站。

We also have -- believe we've addressed the concerns that FDA has raised.

我們還有——相信我們已經解決了 FDA 提出的擔憂。

And it's notable that FDA has not raised any concerns related to the efficacy or safety of inclisiran in any of the interactions that we've had.

值得注意的是，在我們進行的任何互動中，FDA 都沒有對 inclisiran 的有效性或安全性提出任何擔憂。

So this is a Class 2 resubmission, a 6-month time line.

所以這是第 2 類重新提交，6 個月的時間線。

We of course will continue to work with FDA to see if there's opportunities to move this up earlier in the time period.

當然，我們將繼續與 FDA 合作，看看是否有機會在此期間更早地推動這一進程。

But hopefully, now this will get us to a place where we can bring this very important medicine with a very substantial potential for the company to market in the United States.

但希望現在這將使我們能夠將這種非常重要的藥物帶到一個地方，該藥物對公司在美國市場具有非常巨大的潛力。

Now moving to the next slide, turning to Lu-PSMA.

現在轉到下一張幻燈片，轉向 Lu-PSMA。

You likely saw in the ASCO plenary session, the medicine has really remarkable results of 38% reduced risk of death and a 60% improvement in rPFS.

您可能在 ASCO 全體會議上看到，該藥物確實具有顯著的效果，將死亡風險降低了 38%，rPFS 提高了 60%。

Regulatory submissions are on track for the second half.

下半年的監管提交正在按計劃進行。

The movement into earlier line studies with the PSMAfore and the PSMAddition studies are already underway.

與 PSMAfore 和 PSMAAddition 研究一起進入早期線研究的運動已經在進行中。

And we're also evaluating whether to move the medicine even into earlier line settings.

我們還在評估是否將藥物轉移到更早的生產線設置中。

We're working very hard to also expand the relevant capabilities to administer the medicine, and Susanne will speak more about that in a moment.

我們正在非常努力地擴展相關的藥物管理能力，Susanne 稍後會更多地談論這一點。

Moving to the next slide.

轉到下一張幻燈片。

Iptacopan continues to show its utility across a broad range of indications, as you saw in the quarter.

正如您在本季度看到的那樣，Iptacopan 繼續在廣泛的適應症中顯示其效用。

With IgA nephropathy, we presented the primary endpoint at ERA-EDTA, a 23% reduction in proteinuria at 3 months.

對於 IgA 腎病，我們提出了 ERA-EDTA 的主要終點，即 3 個月時蛋白尿減少 23%。

And it's important to note that this was a 3-month time point.

值得注意的是，這是一個 3 個月的時間點。

We expect that proteinuria, over time, to continue to improve as we typically see in studies like this.

我們預計蛋白尿會隨著時間的推移繼續改善，正如我們在此類研究中通常看到的那樣。

So we look forward to looking at the 6 months and beyond endpoint.

因此，我們期待著眼於 6 個月及以後的終點。

Also importantly, there was a stabilization of renal function, which will be very important from a regulatory as well as clinical utility standpoint.

同樣重要的是，腎功能穩定，從監管和臨床效用的角度來看，這將非常重要。

The APPLAUSE IgAN -- IgA nephropathy study is now ongoing to support the filings worldwide in this indication.

APPLAUSE IgAN - IgA 腎病研究目前正在進行中，以支持全球範圍內有關該適應症的申請。

We also continue to progress our C3G indication for this medicine with EU prime designation already achieved.

我們還將繼續推進該藥物的 C3G 適應症，並已獲得歐盟主要指定。

We had a 49% reduction in proteinuria with this medicine at 3 months.

在 3 個月時，我們使用該藥減少了 49% 的蛋白尿。

Again, we would expect that trend to hopefully continue in subsequent months.

同樣，我們預計這種趨勢有望在接下來的幾個月中繼續下去。

A stabilization of renal function, also well tolerated.

腎功能穩定，耐受性也很好。

And this Phase III study now is enrolling to support filings worldwide.

這項 III 期研究現在正在註冊以支持全球範圍內的申請。

And moving to the next slide.

並轉到下一張幻燈片。

When you look at iptacopan in PNH, we also presented data here in the frontline setting to complement the data we already have as an add-on therapy.

當您查看 PNH 中的 iptacopan 時，我們還在前線設置中提供了數據，以補充我們作為附加療法已有的數據。

This new data, which we presented at EHA, showed clinically important benefits of monotherapy of iptacopan.

我們在 EHA 上展示的這一新數據顯示了 iptacopan 單一療法在臨床上的重要益處。

And this novel agent, with its ability to inhibit factor B with a -- both impact intravascular and extravascular hemolysis gives us hope that we can be ultimately indicated for frontline usage as well as add-on to eculizumab.

這種新型藥物具有抑制因子 B 的能力，同時影響血管內和血管外溶血，這讓我們希望最終能夠適應一線使用以及依庫珠單抗的添加。

Worth noting, it's unique as an oral agent with a great safety profile.

值得注意的是，它作為一種具有良好安全性的口服劑是獨一無二的。

So we look forward to completing the APPLY-PNH studies with the superiority endpoints, and then again, to support filings worldwide.

因此，我們期待完成具有優勢終點的 APPLY-PNH 研究，然後再次支持全球範圍內的申請。

As you likely saw as well in our recent Investor Day, on this medicine, we have a broad range of indications also now advancing.

正如您在我們最近的投資者日中可能看到的那樣，在這種藥物上，我們現在也有廣泛的適應症。

We believe this medicine has a substantial potential to treat a range of immunological, renal and hematological diseases.

我們相信這種藥物具有治療一系列免疫、腎臟和血液疾病的巨大潛力。

Now moving to the next slide.

現在轉到下一張幻燈片。

One piece of data that came out in the quarter that didn't attract as much attention as what one might have expected is our Zolgensma SPR1NT data.

本季度出現的一項數據沒有引起人們預期的那麼多關注，那就是我們的 Zolgensma SPR1NT 數據。

This was remarkable data showing the impact that gene therapy can have on children with SMA.

這是顯著的數據，顯示了基因治療對 SMA 兒童的影響。

In this study, 100% of the patients met the primary endpoint of sitting independently when treated in the presymptomatic setting.

在這項研究中，100% 的患者在症狀前環境中接受治療時達到了獨立坐姿的主要終點。

So these are patients who are identified through newborn screening and treated with Zolgensma.

因此，這些是通過新生兒篩查發現並接受 Zolgensma 治療的患者。

100% of patients met the secondary endpoint.

100% 的患者達到次要終點。

Also with respect to walking and standing, we saw remarkable gains for these patients, which we hope will continue to improve over time.

同樣在行走和站立方面，我們看到這些患者取得了顯著的進步，我們希望隨著時間的推移會繼續改善。

This data reinforces that Zolgensma is a foundational therapy for presymptomatic and symptomatic children with SMA.

該數據強化了 Zolgensma 是針對 SMA 症狀前和有症狀兒童的基礎療法。

It also continues to give us confidence that, over time, as gene therapies as a sector matures, our capabilities in gene therapy, having learned so much with the introduction of Zolgensma around the world, building outstanding manufacturing and technical capabilities, will allow us in the long term to be a leader in gene therapies for the decade to come.

它還繼續讓我們相信，隨著時間的推移，隨著基因治療作為一個行業的成熟，我們在基因治療方面的能力，通過在世界各地引入 Zolgensma 學到了很多，建立了卓越的製造和技術能力，將使我們能夠在長期成為未來十年基因療法的領導者。

Now moving to the next slide.

現在轉到下一張幻燈片。

I also wanted to say, and as a last note on the pipeline, an update on the sabatolimab STIMULUS program, which is progressing in MDS and AML.

我還想說，作為管道的最後一點，關於 sabatolimab STIMULUS 計劃的更新，該計劃正在 MDS 和 AML 中取得進展。

Now as a reminder, in Phase I studies, we showed that sabatolimab had 50% or -- 58% ORR in myelodysplastic syndromes.

現在提醒一下，在 I 期研究中，我們表明 sabatolimab 在骨髓增生異常綜合徵中具有 50% 或 -- 58% 的 ORR。

And given this unique mechanism of action, it's the first IO agent in the hematological setting.

鑑於這種獨特的作用機制，它是血液學環境中的第一個 IO 代理。

It gave us confidence to move forward in MDS and AML with the STIMULUS programs, which are pivotal studies that tackle both of these indications.

它讓我們有信心通過 STIMULUS 計劃在 MDS 和 AML 方面取得進展，這是解決這兩個適應症的關鍵研究。

Now the parallel execution of these trials offers us a range of filing options.

現在，這些試驗的並行執行為我們提供了一系列歸檔選項。

We did have the CR readout, and the DMC recommended that we continue the study blinded to the PFS readout.

我們確實有 CR 讀數，DMC 建議我們繼續對 PFS 讀數不知情的研究。

And then, of course, the OS readout as well will come over time.

然後，當然，操作系統讀數也會隨著時間的推移而出現。

It's also worth noting in the MDS program, we have a third study in the STIMULUS array of studies that also looks at the -- with a triplet combination, including venetoclax.

在 MDS 計劃中還值得注意的是，我們在 STIMULUS 一系列研究中進行了第三項研究，該研究還著眼於 - 三聯體組合，包括 venetoclax。

So we believe we have a program that can adequately cover the range of potential options that would be needed for patients to be treated effectively with medicines such as MBG.

因此，我們相信我們的計劃可以充分涵蓋患者使用 MBG 等藥物有效治療所需的潛在選擇範圍。

So we remain very excited about the program.

所以我們仍然對這個計劃感到非常興奮。

We think scientifically, mechanistically, and as a first-in-class asset, it can be an important addition to AML and MDS treatment, an area that we've been a leader in for many years.

我們以科學、機械的方式思考，作為一流的資產，它可以成為 AML 和 MDS 治療的重要補充，這是我們多年來一直處於領先地位的領域。

So we'll look forward to keeping you updated on this program.

因此，我們期待您及時了解該計劃。

Now moving to ESG.

現在轉向 ESG。

We had strong progress on ESG.

我們在 ESG 方面取得了長足的進步。

I think some notable milestones in our effort to be a leader in this space.

我認為我們在努力成為該領域的領導者方面取得了一些顯著的里程碑。

We reached 1 billion courses of antimalarial treatment delivered since 1999.

自 1999 年以來，我們提供了 10 億個療程的抗瘧治療。

It's 1 billion patients we've been able to treat with our Coartem, a pioneering agent to treat malaria.

我們已經能夠使用我們的 Coartem 治療 10 億名患者，這是一種治療瘧疾的先驅藥物。

Very proud of that achievement.

為這一成就感到非常自豪。

We also recently announced a 10-year commitment to empower 1,200 African-American students, working with historically black colleges and universities to really address the inequities in medical education, and broadly, inequities in health care in the United States.

我們最近還宣布了一項為期 10 年的承諾，即賦予 1,200 名非裔美國學生權力，與歷史上的黑人學院和大學合作，真正解決醫學教育方面的不公平問題，以及廣泛地解決美國醫療保健方面的不公平問題。

And you can see other important milestones that we hit over the course of the quarter.

您可以看到我們在本季度實現的其他重要里程碑。

So we'll look forward to continuing our progress on this front and being a leader in ESG for the long term, ultimately embedding this into our business to drive long-term performance.

因此，我們期待在這方面繼續取得進展，並長期成為 ESG 的領導者，最終將其嵌入我們的業務以推動長期業績。

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

因此，我將把它交給 Marie-France。

Thank you, Vas.

謝謝你，瓦斯。

Good morning, good afternoon to all.

早上好，大家下午好。

And pleased to update you on our Q2 pharma performance.

很高興向您介紹我們第二季度的製藥業績。

If we move to Slide 19.

如果我們轉到幻燈片 19。

We delivered 12% growth versus prior year and an additional $1 billion in revenues.

與去年相比，我們實現了 12% 的增長，並增加了 10 億美元的收入。

As you can also see, we also continue to make progress on our portfolio shift.

如您所見，我們還在投資組合轉變方面繼續取得進展。

Our growth drivers and launches are showing excellent momentum with 35% growth, and these now contribute to more than 50% of our top line thanks to our strong focus on execution.

我們的增長動力和新品發布勢頭強勁，增長了 35%，由於我們對執行的高度重視，這些現在貢獻了超過 50% 的收入。

You can expect this shift to continue as we invest behind our growth drivers and launches and also actively manage the mature portfolio.

隨著我們投資於我們的增長動力和發布，並積極管理成熟的投資組合，您可以預期這種轉變將繼續下去。

If we move to Slide 20.

如果我們轉到幻燈片 20。

Consentyx delivered 21% growth.

Consentyx 實現了 21% 的增長。

U.S. volume growth in Q2 is now back in line with the market and sales were up 11% quarter-over-quarter.

美國第二季度的銷量增長現在與市場保持一致，銷售額環比增長 11%。

Our field force activity is above pre-COVID levels.

我們的現場部隊活動高於 COVID 之前的水平。

And as we see the market regaining momentum, we also intend to capture more volume.

當我們看到市場重新獲得動力時，我們也打算獲得更多的成交量。

Ex U.S., we had really strong growth in Europe.

除美國外，我們在歐洲的增長非常強勁。

And in China, we quadrupled sales versus Q1 following the NRDL listing in March.

在中國，在 3 月份國家醫保目錄上市後，我們的銷售額與第一季度相比翻了兩番。

So full year, we're on track to deliver double-digit growth based on our broad access, our ongoing geographic expansion and the continued investment.

全年，我們有望實現兩位數的增長，基於我們廣泛的訪問、我們持續的地域擴張和持續的投資。

We can now proudly say that 500,000 patients have been treated with Cosentyx.

我們現在可以自豪地說，已有 500,000 名患者接受了 Cosentyx 的治療。

And with our ambition to expand to 10 indications, we know that many more can benefit.

憑藉我們擴大到 10 種適應症的雄心，我們知道更多的適應症可以從中受益。

We'll continue to invest with additional approvals in the short term and with our hidradenitis suppurativa readout towards the end of the year.

我們將在短期內繼續投資，獲得額外的批准，並在年底前完成我們的化膿性汗腺炎讀數。

If we move to the next slide.

如果我們轉到下一張幻燈片。

Entresto saw another very strong quarter with 46% growth.

Entresto 又迎來了一個非常強勁的季度，增長了 46%。

In the U.S., you can see from the NBRx growth that we're really capitalizing on the ACC consensus recommendation and also on the expanded label.

在美國，您可以從 NBRx 的增長中看到，我們確實在利用 ACC 共識建議以及擴展標籤。

In Europe, the ESC guidelines now recommend Entresto as first line, and that is further reinforcing our position as first choice.

在歐洲，ESC 指南現在建議將 Entresto 作為第一線，這進一步鞏固了我們作為首選的地位。

China, we tripled sales compared to previous year on the back of strategic account expansion.

在中國，由於戰略客戶擴張，我們的銷售額比上一年增長了兩倍。

In fact, China is now Entresto's second-biggest market.

事實上，中國現在是 Entresto 的第二大市場。

So this team is strongly focused on execution, educating prescribers on guidelines, activating patients and ensuring the guidelines become protocol at hospital level.

因此，這個團隊非常專注於執行、對開處方者進行指南教育、激活患者並確保指南成為醫院層面的協議。

You can expect to see the usual summer slowdown.

您可以期待看到通常的夏季放緩。

However, full year, we will stay strong as we address the remaining 70% of patients who do not yet benefit from Entresto.

然而，在全年，我們將保持強大，因為我們會解決剩餘的 70% 尚未從 Entresto 中受益的患者。

If I move to Slide 22.

如果我轉到幻燈片 22。

Zolgensma is continuing its growth trajectory as we open up reimbursement in new markets.

隨著我們在新市場開闢報銷，Zolgensma 正在繼續其增長軌跡。

As you heard Vas say earlier, we've got compelling data in presymptomatic patients, and thus, it's really important for us to continue the work to implement newborn screening.

正如您之前聽到 Vas 所說，我們已經獲得了症狀前患者的令人信服的數據，因此，繼續開展新生兒篩查工作對我們來說非常重要。

As we know, the earlier we treat, the more transformational the outcomes are for these babies.

正如我們所知，我們越早治療，這些嬰兒的結果就越具有變革性。

In the U.S., 80% of newborns are being screened, and this is allowing treatment within a few weeks of birth.

在美國，80% 的新生兒正在接受篩查，這允許在出生後幾週內進行治療。

Ex-U.

前U。

S., we expect to see Italy and the U.K. and additional reimbursed markets to drive the growth in the second half.

S.，我們預計意大利和英國以及其他報銷市場將推動下半年的增長。

And even though you can continue to expect some volatility in the quarterly pattern, we're on track to exceed blockbuster status this year.

儘管您可以繼續預期季度模式會出現一些波動，但我們有望在今年超越重磅炸彈。

Our preclinical studies for IT are progressing well, and we're actually ready to start our Phase III as soon as the FDA gives us the green light.

我們的 IT 臨床前研究進展順利，一旦 FDA 給我們開綠燈，我們實際上已經準備好開始我們的 III 期研究。

Over time, the IT formulation can more than double the number of patients who could benefit from Zolgensma.

隨著時間的推移，IT 配方可以使受益於 Zolgensma 的患者數量增加一倍以上。

If we move to the next slide.

如果我們轉到下一張幻燈片。

With Kesimpta, our focus is on broad adoption in early lines of therapy.

對於 Kesimpta，我們的重點是在早期治療中的廣泛採用。

We've added 500 new prescribers and we've doubled the number of patients on Kesimpta versus Q1.

我們增加了 500 名新的開藥者，我們將 Kesimpta 的患者數量與 Q1 相比增加了一倍。

We also see that half of the Kesimpta usage is a naive or first switch.

我們還看到 Kesimpta 的一半使用是天真的或第一次切換。

And this is exactly where we want to be.

這正是我們想要的。

The B-cell class is currently leading the recovery of the dynamic market, and Kesimpta has got the second-highest NBRx share in the MS space.

B 細胞類目前正在引領動態市場的複蘇，而 Kesimpta 在 MS 領域獲得了第二高的 NBRx 份額。

So this positions us well as the market opens up further.

因此，隨著市場進一步開放，這使我們處於有利地位。

As we move to the second half of the year, we know what we need to do to double demand, and we're doing what is needed for a strong Q4.

隨著我們進入下半年，我們知道我們需要做什麼才能使需求翻倍，並且我們正在做強勁的第四季度所需的事情。

We're maintaining our leading share of voice to really increase the awareness of Kesimpta.

我們正在保持領先的聲音份額，以真正提高 Kesimpta 的知名度。

We also believe that our PIRA and our IgG data provide important clinical differentiation.

我們還相信我們的 PIRA 和我們的 IgG 數據提供了重要的臨床差異化。

So we're fully focused on what we need to do.

所以我們完全專注於我們需要做的事情。

We're also fully focused on delivering a positive customer experience.

我們還完全專注於提供積極的客戶體驗。

In fact, 80% of patients are receiving their first dose within 5 days, and our patient support services are enabling fast and easy initiation.

事實上，80% 的患者在 5 天內接受了他們的第一劑，我們的患者支持服務正在實現快速和輕鬆的啟動。

If I move on to Slide 24 and move on to Leqvio.

如果我轉到幻燈片 24 並轉到 Leqvio。

We all know that ASCVD is the leading cause of death, and unfortunately, mortality is on the rise.

我們都知道 ASCVD 是導致死亡的主要原因，不幸的是，死亡率正在上升。

There are effective treatments.

有有效的治療方法。

We know that, too.

我們也知道這一點。

But patients are not at goal due to access, adherence and affordability challenges.

但由於獲取、依從性和負擔能力方面的挑戰，患者並未達到目標。

And this is why we're taking a different approach on how we bring Leqvio to market.

這就是我們在如何將 Leqvio 推向市場方面採取不同方法的原因。

In the U.S., we've got a new action date for January, and we're preparing for launch.

在美國，我們將新的行動日期定為 1 月，我們正在為發布做準備。

Our access strategy could actually enable 2/3 of patients at launch to access Leqvio with a $0 copay.

我們的訪問策略實際上可以使 2/3 的患者在啟動時以 0 美元的共付額訪問 Leqvio。

So we're working with health care systems on broad adoption.

因此，我們正在與醫療保健系統合作以廣泛採用。

We're using our existing infrastructure to identify patients and also to set up buy-and-bill administration.

我們正在使用我們現有的基礎設施來識別患者並建立購買和賬單管理。

In the U.K., we're partnering with the NHS to bring Leqvio to more than 300,000 patients at risk of a second CV event over the next 3 years, and we're on track for that launch in Q3.

在英國，我們正在與 NHS 合作，在未來 3 年內將 Leqvio 帶給超過 300,000 名面臨第二次心血管事件風險的患者，我們有望在第三季度推出該產品。

We understand this approach will take time, and further evidence generation.

我們知道這種方法需要時間和進一步的證據生成。

But this level of ambition is absolutely necessary if we want to drive better outcomes for ASCVD patients.

但是，如果我們想為 ASCVD 患者帶來更好的結果，這種雄心壯志是絕對必要的。

So in summary.

所以總結一下。

An excellent quarter.

一個優秀的季度。

We're fully focused on our strategy to maximize our growth drivers, deliver our launches and also prepare for the next wave of Innovative Medicines.

我們完全專注於我們的戰略，以最大限度地提高我們的增長動力，推出我們的產品，並為下一波創新藥物做準備。

As we further accelerate our portfolio shift, we're also transforming our business.

隨著我們進一步加快我們的投資組合轉變，我們也在轉變我們的業務。

We want to be much more customer-centric and also pursue innovative approaches to launch our products in partnership with health care systems around the world.

我們希望更加以客戶為中心，並尋求創新方法與世界各地的醫療保健系統合作推出我們的產品。

So coming out of Q2, we had good momentum across the globe, which we expect will continue in the second half.

因此，從第二季度開始，我們在全球範圍內擁有良好的勢頭，我們預計下半年將繼續保持這種勢頭。

I want to take a moment to recognize the fantastic teams around the [world] for their hard work and for delivering these results.

我想花一點時間來表彰 [世界] 出色的團隊，他們的辛勤工作和取得的成果。

Over to you, Susanne.

交給你了，蘇珊。

Thank you, Marie-France.

謝謝你，瑪麗-法蘭西。

And moving to Slide 26, I'm very pleased to give an update on the Oncology business.

轉到幻燈片 26，我很高興提供有關腫瘤學業務的最新信息。

So the Oncology business showed very solid performance in the second quarter, delivering 7% of growth with sales reaching $3.9 billion.

因此，腫瘤業務在第二季度表現出非常穩健的表現，實現了 7% 的增長，銷售額達到 39 億美元。

Our growth drivers and recent launches are showing good momentum with 19% growth versus prior year, driven by Kisqali, Jakavi, Promacta/Revolade and Kymriah.

在 Kisqali、Jakavi、Promacta/Revolade 和 Kymriah 的推動下，我們的增長動力和最近推出的產品顯示出良好的勢頭，與去年相比增長了 19%。

And together, these products now contribute to half of the overall oncologies, allowing us to more than offset losses from continued generic erosion of Glivec, Afinitor and Exjade/Jadenu in the U.S.

加在一起，這些產品現在佔整體腫瘤學的一半，使我們能夠抵消格列衛、Afinitor 和 Exjade/Jadenu 在美國持續仿製藥侵蝕造成的損失。

In Q2, the oncology market continued to be affected by COVID-19.

在第二季度，腫瘤市場繼續受到 COVID-19 的影響。

Oncologists are reporting that there's case load, depending on geography, is still 25% to 50% below pre-COVID level.

腫瘤學家報告說，根據地理位置的不同，病例數量仍比 COVID 之前的水平低 25% 到 50%。

And most affected areas are our breast cancer portfolio, recent launches, and hospital-initiated therapies like Kymriah and Lutathera.

受影響最大的領域是我們的乳腺癌產品組合、最近推出的產品以及醫院啟動的療法，如 Kymriah 和 Lutathera。

Looking at Kymriah, this grew globally 19%, and it was driven by strong ex-U.

看看 Kymriah，這在全球範圍內增長了 19%，這是由強大的前美國推動的。

S. growth and geographic expansion.

S. 增長和地域擴張。

In the U.S., we remain very competitive.

在美國，我們仍然非常具有競爭力。

However, overall demand in the class has slowed down.

然而，班級的整體需求已經放緩。

And Lutathera sales were growing 10% in Q2.

第二季度 Lutathera 的銷售額增長了 10%。

The ex-U.

前U。

S. growth was double digit.

S.增長是兩位數。

And we also saw positive sickness in the U.S. as it is emerging from COVID and referrals started to increase.

我們還在美國看到了積極的疾病，因為它正在從 COVID 中出現，並且轉診開始增加。

So overall, we remain confident that patient visits to hospitals will increase and treatment patterns will further improve in the second half of the year, leading to acceleration of growth in these segments.

因此，總體而言，我們仍然相信，下半年的患者就診次數將增加，治療模式將進一步改善，從而加速這些領域的增長。

Moving to Slide 27.

轉到幻燈片 27。

I wanted to share a bit on our performance in the U.S. U.S. remains our biggest market globally and is contributing to over 40% of our overall oncology sales.

我想分享一下我們在美國的表現。美國仍然是我們全球最大的市場，占我們整體腫瘤學銷售額的 40% 以上。

Our growth brands and launches contribute to 49% of sales.

我們的成長型品牌和新品發布貢獻了 49% 的銷售額。

The U.S. market is slowly recovering from the pandemic with oncologists' case load now reaching 75% of pre-COVID level.

美國市場正在從大流行中緩慢恢復，腫瘤學家的病例數量現已達到 COVID 前水平的 75%。

However, testing rates for the most common tumor types remain suppressed in Q1, delaying diagnosis and new prescriptions.

然而，最常見腫瘤類型的檢測率在第一季度仍然受到抑制，從而延遲了診斷和新處方。

In Q2, we have seen partial recovery of our growth drivers and recent launches, together growing 10% versus previous year and also accelerating versus previous quarter.

在第二季度，我們的增長驅動力和近期推出的產品出現了部分複蘇，與去年同期相比增長了 10%，並且與上一季度相比也在加速增長。

So this was mainly driven by Promacta, Kisqali and Taf/Mek.

所以這主要是由 Promacta、Kisqali 和 Taf/Mek 推動的。

Overall, with continued recovery of the market, we expect acceleration of sales in the U.S. in the second half of the year.

總體而言，隨著市場的持續復甦，我們預計下半年在美國的銷售將加速。

Moving to Kisqali on Slide 28.

在幻燈片 28 上移動到 Kisqali。

Kisqali delivered strong performance second quarter, growing 36% with sales of $225 million.

Kisqali 第二季度業績強勁，增長 36%，銷售額為 2.25 億美元。

The uptake was mainly driven by continued momentum in patient share gains ex-U.

這種吸收主要是由美國以外患者份額增長的持續勢頭推動的。

S. and particularly in Europe.

S.，特別是在歐洲。

Kisqali is the market leader in premenopausal setting in France, Italy and Spain.

Kisqali 是法國、意大利和西班牙絕經前環境的市場領導者。

And in the U.S., we have also seen Kisqali sales getting traction, delivering 17% versus previous quarter, driven by increased demand and new patient starts.

在美國，我們也看到 Kisqali 的銷售額獲得牽引力，與上一季度相比增長了 17%，這得益於需求增加和新患者的啟動。

We see increased field force reach in those accounts where access restrictions were lifted, and we also continue to leverage digital engagement based on dynamic targeting.

我們看到，在取消訪問限制的賬戶中，外勤人員的覆蓋範圍有所增加，我們還繼續利用基於動態定位的數字參與。

At ASCO, we presented updated OS data from our MONALEESA-3 trial that showed consistent OS benefit with a median OS of 4 to 5 years.

在 ASCO，我們提供了來自 MONALEESA-3 試驗的更新 OS 數據，該數據顯示一致的 OS 獲益，中位 OS 為 4 至 5 年。

And with this data, Kisqali demonstrated the longest OS in postmenopausal patients and is the only CDK4/6 inhibitor with data in first line with fulvestrant.

有了這些數據，Kisqali 證明了絕經後患者的 OS 最長，並且是唯一一個與氟維司群一線數據的 CDK4/6 抑製劑。

We believe that these excellent results may be attributed to the unique profile of Kisqali versus other CDK4/6 inhibitors, with preferential inhibition to CDK4 over CDK6 and a high concentration to inhibit the target.

我們認為，這些出色的結果可能歸因於 Kisqali 與其他 CDK4/6 抑製劑相比的獨特特性，對 CDK4 的抑制優先於 CDK6 和高濃度以抑制靶標。

In addition, we are going into the adjuvant setting with our NATALEE study, exploring Kisqali in both intermediate and high-risk population.

此外，我們將通過我們的 NATALEE 研究進入輔助環境，在中高風險人群中探索 Kisqali。

And just to remind you, this population represents around 70% of the adjuvant early breast cancer population, and there's a clear unmet medical need.

提醒您一下，這一人群約佔早期乳腺癌輔助治療人群的 70%，並且存在明顯未滿足的醫療需求。

I am very pleased to report that the enrollment of the NATALEE study is completed, and we are on track for readout in 2022.

我很高興地報告說，NATALEE 研究的註冊已經完成，我們有望在 2022 年進行讀數。

Moving to Slide 29.

轉到幻燈片 29。

As you heard from Vas, we are very excited about data from the VISION trial that positions lutetium-PSMA well to potentially address the unmet needs of more than 80% of men with late-stage advanced prostate cancer who express PSMA receptors.

正如您從 Vas 那裡聽到的，我們對 VISION 試驗的數據感到非常興奮，這些數據使镥-PSMA 能夠很好地解決 80% 以上表達 PSMA 受體的晚期晚期前列腺癌男性未滿足的需求。

And just to remind you that prostate cancer is the second most diagnosed cancer globally.

並且只是提醒您，前列腺癌是全球第二大確診癌症。

And in the majority of cases, patients unfortunately, developed metastases by the time of castration-resistant prostate cancer diagnosis.

在大多數情況下，不幸的是，患者在去勢抵抗性前列腺癌診斷時發生了轉移。

Earlier in June, we got breakthrough therapy granted by the FDA, and filing to FDA is on track for the second half of '21.

6 月初，我們獲得了 FDA 授予的突破性療法，並在 21 年下半年向 FDA 提交申請。

We are fully in launch preparation with focus on the top 200 treatment centers, and are also working on raising awareness on the clinical relevance of PSMA.

我們正在全力準備推出前 200 家治療中心，同時也在努力提高人們對 PSMA 臨床相關性的認識。

Very pleased to see growth in the PSMA.

很高興看到 PSMA 的增長。

Awareness has doubled among the target physicians over the last month.

上個月，目標醫生的意識翻了一番。

And just to reassure you that we have adequate capacity to meet the demand for the current launch.

只是為了向您保證，我們有足夠的能力來滿足當前發布的需求。

So our focus will be on driving referrals from community centers, where 70% of prostate cancer patients are treated.

因此，我們的重點將是推動社區中心的轉診，那裡有 70% 的前列腺癌患者接受治療。

When you model the lutetium-PSMA launch, keep in mind that hospitals need to set up processes and licenses and patients need to be selected through PSMA PET scannings.

當您對 lutetium-PSMA 發射進行建模時，請記住，醫院需要設置流程和許可證，並且需要通過 PSMA PET 掃描來選擇患者。

And these factors are likely to drive a more gradual uptake at launch versus what you saw with the bolus effect on Lutathera.

與您在 Lutathera 上看到的推注效應相比，這些因素可能會在發射時推動更漸進的吸收。

Moving to the next slide, Slide 30.

轉到下一張幻燈片，幻燈片 30。

I would like to talk about a launch preparation for asciminib, the first STAMP inhibitor that has the potential to transform CML treatment standards again.

我想談談 asciminib 的上市準備，這是第一個有可能再次改變 CML 治療標準的 STAMP 抑製劑。

In the Phase III ASCEMBL study, asciminib nearly doubled the major molecular response at 24 weeks compared to bosutinib.

在 III 期 ASCEMBL 研究中，與 bosutinib 相比，asciminib 在 24 週時的主要分子反應幾乎翻了一番。

We have completed filings for FDA and EMA earlier in June, and the FDA has granted 2 breakthrough therapy designations and fast track designations for asciminib and is reviewing the file under real-time oncology review.

我們已於 6 月初完成向 FDA 和 EMA 的備案，FDA 已授予阿西米尼 2 項突破性治療指定和快速通道指定，並正在實時腫瘤學審查中審查該文件。

As we are preparing for the launch, our focus is on raising awareness on importance of STAMP inhibition to overcome resistance and minimizing off-target events typical for TKIs.

在我們準備發佈時，我們的重點是提高人們對 STAMP 抑制重要性的認識，以克服阻力並最大限度地減少 TKI 典型的脫靶事件。

Aided awareness has already reached 75%.

輔助意識已經達到75%。

And just to remind you, the third line indication for asciminib has already blockbuster potential.

提醒您一下，asciminib 的三線適應症已經具有巨大的潛力。

But we are also very excited by the potential benefit that asciminib may provide to CML patients in first-line setting.

但我們也對 asciminib 可能為一線 CML 患者提供的潛在益處感到非常興奮。

Despite the advancements in treatment of CML over the last 20 years, there are still around 50% of patients who relapse or are intolerant to imatinib in first line.

儘管在過去 20 年中 CML 的治療取得了進展，但仍有約 50% 的患者復發或對一線伊馬替尼不耐受。

And more than 30% of patients suffer from TKI-related nonhematological AIs.

超過 30% 的患者患有 TKI 相關的非血液學 AI。

We believe that, in earlier lines of CML treatment, asciminib may prevent resistance currently available TKIs.

我們相信，在早期的 CML 治療中，阿西米尼可能會預防目前可用的 TKI 的耐藥性。

And therefore, we are initiating a Phase III study of asciminib versus investigator-selected TKIs, with enrollment planned to start in the second half of '21.

因此，我們正在啟動一項關於 asciminib 與研究者選擇的 TKI 的 III 期研究，計劃於 21 年下半年開始招募。

So moving to Slide 31.

所以轉到幻燈片 31。

We have made great progress on our innovation agenda, and '21 is a very important year in terms of readouts and submission.

我們在創新議程上取得了很大進展，21 年是讀出和提交方面非常重要的一年。

In addition to the VISION data, we had multiple readouts like positive data from to iptacopan in PNH, alpelisib in PROS, Kymriah follicular lymphoma and OS data for Lutathera.

除了 VISION 數據，我們還有多個讀數，例如 PNH 中 iptacopan 的陽性數據、PROS 中的 alpelisib、Kymriah 濾泡性淋巴瘤和 Lutathera 的 OS 數據。

Canakinumab readout in second line non-small lung cancer did unfortunately not show positive data, but it is very important to mention that we have 2 more studies ongoing in first line and adjuvant non-small cell lung cancer, with the first line trial on track to read out in second half of '21.

不幸的是，卡那奴單抗在二線非小細胞肺癌中的讀數沒有顯示出陽性數據，但非常重要的是，我們在一線和輔助非小細胞肺癌中還有 2 項研究正在進行中，一線試驗正在進行中在 21 年下半年讀出。

Later in the year, we're also expecting Kymriah to read out in second line non-Hodgkin's lymphoma and Kisqali OS data from MONALEESA-2.

今年晚些時候，我們還期待 Kymriah 在第二線非霍奇金淋巴瘤和來自 MONALEESA-2 的 Kisqali OS 數據中讀出。

In terms of submission, we have completed submissions for GvHD for Jakavi in Europe and Japan, Tabrecta at in Europe and asciminib in third line U.S. and Europe.

在提交方面，我們已經完成了歐洲和日本的 Jakavi 的 GvHD 提交，歐洲的 Tabrecta 和美國和歐洲的三線 asciminib 的提交。

And for H2, we are on track for filing of lutetium PSMA; Kymriah in follicular lymphoma, and second line on non-Hodgkin's lymphoma; and tislelizumab in non-small cell lung cancer and second line esophageal cancer.

對於 H2，我們正在提交镥 PSMA； Kymriah 治療濾泡性淋巴瘤，二線治療非霍奇金淋巴瘤；和替雷利珠單抗治療非小細胞肺癌和二線食管癌。

So exciting times ahead for oncology.

腫瘤學即將迎來激動人心的時刻。

Big thank you to all the teams.

非常感謝所有團隊。

And with that, I hand over to Harry.

有了這個，我交給哈利。

Yes.

是的。

Thank you, Susanne.

謝謝你，蘇珊。

Good morning and good afternoon, everybody.

大家早上好，下午好。

So I'm now going to walk you through some of the financials for the second quarter and the first half of the year.

因此，我現在將向您介紹第二季度和上半年的一些財務狀況。

And as always, my comments refer to growth rates in constant currencies unless otherwise noted.

和往常一樣，除非另有說明，否則我的評論指的是固定貨幣的增長率。

So on Slide 33.

所以在幻燈片 33 上。

You see the summary of our operational performance for the second quarter and the first half.

您會看到我們第二季度和上半年的運營業績摘要。

We had a strong quarter 2, resulting in a solid first half performance despite the impact of COVID during the period.

我們在第二季度表現強勁，儘管在此期間受到 COVID 的影響，但上半年業績依然穩健。

Quarter 2 net sales grew 9% to $13 billion driven by our key growth drivers.

在我們的主要增長動力的推動下，第二季度的淨銷售額增長了 9% 至 130 億美元。

And core operating income grew 13% to $4.3 billion, mainly driven by the higher sales and favorable gross margin, partly offset by higher investments.

核心營業收入增長 13% 至 43 億美元，主要受較高銷售額和有利毛利率的推動，部分被較高的投資所抵消。

Core EPS growth was also up 16% to $1.66.

核心每股收益增長也增長了 16% 至 1.66 美元。

And free cash flow grew 17% to USD 4.2 billion.

自由現金流增長 17% 至 42 億美元。

Of course, we appreciate the benefit on comparison from the low base in quarter 2 2020 due to the COVID destocking in the prior year.

當然，我們很欣賞與 2020 年第 2 季度的低基數相比的好處，這是由於前一年的 COVID 去庫存。

However, even when excluded, we still return to healthy growth with sales up 5% and core operating income growing 4%, quarter 2 2021 underlying.

然而，即使排除在外，我們仍會恢復健康增長，銷售額增長 5%，核心營業收入增長 4%，基本是 2021 年第二季度。

Our half 1 performance was solid with 3% growth on the top line and 2% on the bottom line.

我們的半年業績穩健，收入增長 3%，利潤增長 2%。

Core EPS grew 5% to $3.17, and free cash flow was $6 billion.

核心每股收益增長 5% 至 3.17 美元，自由現金流為 60 億美元。

Of course, for half 1, the quarter 2, quarter 1 destocking, stocking from the prior year has washed out.

當然，1、2季度、1季度去庫存，上年的庫存已經洗掉了。

So these values represent underlying growth of half 1 2021.

因此，這些值代表了 2021 年上半年的潛在增長。

Next slide, please.

請下一張幻燈片。

So on Slide 34, I want to dive into our performance during the quarter by division.

所以在幻燈片 34 上，我想按部門深入了解我們在本季度的表現。

Innovative Medicines delivered a strong quarter with plus 10% top line and plus 14% bottom line growth and a margin of 37%.

創新藥物的季度表現強勁，收入增長 10%，利潤增長 14%，利潤率為 37%。

Even if we adjust for last year's lower base, we still saw strong growth with Innovative Medicine sales increasing 7% and core operating income up 6%.

即使我們調整了去年較低的基數，我們仍然看到了強勁的增長，創新藥物銷售額增長了 7%，核心營業收入增長了 6%。

The Innovative Medicines performance was driven by continued strong double-digit growth of our key growth drivers, including Cosentyx, Entresto, Zolgensma and the oncology launch brands.

創新藥物的業績是由我們的主要增長驅動因素持續強勁的兩位數增長推動的，包括 Cosentyx 、 Entresto 、 Zolgensma 和腫瘤學推出品牌。

And as Vas mentioned earlier in the presentation, our growth drivers and launches are driving portfolio rejuvenation and now account for over half of our Innovative Medicines sales.

正如 Vas 在演講中前面提到的，我們的增長動力和發布正在推動產品組合的年輕化，現在占我們創新藥物銷售額的一半以上。

Of course, the pandemic still impacts our business, particularly Sandoz retail and the anti-infective segment.

當然，大流行仍然影響著我們的業務，尤其是山德士零售和抗感染部門。

However, the Sandoz business is now beginning to stabilize with sales up plus 5% in quarter 2 and bottom line growing 3%, although growth did also benefit from prior year destocking.

然而，山德士業務現在開始趨於穩定，第二季度銷售額增長了 5%，利潤增長了 3%，儘管增長也受益於去年的去庫存。

Now turning to our full year guidance on Slide 35.

現在轉向我們對幻燈片 35 的全年指導。

We confirm full year guidance for both the group sales and core operating income.

我們確認集團銷售額和核心營業收入的全年指引。

For sales, we continue to expect low to mid-single-digit growth in 2021.

對於銷售額，我們繼續預計 2021 年將出現中低個位數增長。

And for the bottom line, we expect mid-single-digit growth ahead of sales.

對於底線，我們預計銷售額將實現中個位數增長。

For Innovative Medicines and Sandoz, we are also not making any changes.

對於創新藥物和山德士，我們也沒有做出任何改變。

We continue to expect Innovative Medicines division sales to grow mid-single digit and core operating income to grow mid- to high single-digit ahead of sales.

我們繼續預計創新藥物部門的銷售額將增長中個位數，核心營業收入將在銷售額之前增長中高個位數。

And for Sandoz, we continue to expect sales to decline in the low to mid-single-digit range and core operating income to decline low to mid-teens.

對於山德士，我們繼續預計銷售額將下降至中低個位數範圍，核心營業收入將下降至低至十幾歲。

The key assumption for the guidance is that we see a continuation of the return to normal global health care systems and prescribing dynamics in the second half of this year.

該指南的關鍵假設是，我們看到今年下半年全球醫療保健系統和處方動態將繼續恢復正常。

And in addition, we continue to assume that no Gilenya and no Sandostatin LAR generics would enter in 2021 in the U.S.

此外，我們繼續假設 Gilenya 和 Sandostatin LAR 仿製藥不會在 2021 年進入美國。

On next slide, we provide some detail on our expectations for the second half of the year.

在下一張幻燈片中，我們將詳細介紹我們對下半年的預期。

We expect top line growth to accelerate from 3% in half 1 to mid-single digit, bringing us to the low to mid-single-digit range for the full year.

我們預計收入增長將從半年的 3% 加速至中個位數，使我們全年進入中低個位數範圍。

Our assumption is that this will be driven by growth acceleration as we continue to return to normal prescribing behaviors as well as further Sandoz stabilization.

我們的假設是，隨著我們繼續恢復正常的處方行為以及山德士的進一步穩定，這將受到增長加速的推動。

We expect core operating income growth to be high single digit in half 2, reaching our mid-single-digit expectation for the full year.

我們預計核心營業收入將在 2 年內保持高個位數增長，達到我們全年的中個位數預期。

Core operating income growth will be driven by higher sales and ongoing productivity programs partly offset by increased investments in our growth drivers and pipeline.

核心營業收入增長將受到更高的銷售額和持續的生產力計劃的推動，部分被我們對增長動力和管道的投資增加所抵消。

It is possible that we could reach the higher end of the ranges we have provided.

我們有可能達到我們提供的範圍的高端。

But as you know, the COVID situation still remains fluid.

但如您所知，COVID 的情況仍然不穩定。

Finally, on Slide 37.

最後，在幻燈片 37 上。

As currencies are constantly changing, I want to bring to your attention the estimated currency impact on our results using the current exchange rates.

由於貨幣不斷變化，我想提請您注意使用當前匯率估算的貨幣對我們結果的影響。

So if mid-July rates prevail for the remainder of 2021, the full year impact of currencies on sales would be positive 2%; and on core operating income, positive 2 to 3 percent points.

因此，如果 7 月中旬的利率在 2021 年剩餘時間內占主導地位，那麼貨幣對銷售額的全年影響將是 2%；核心營業收入增長 2 至 3 個百分點。

For quarter 3, it will be positive 1 percent point on sales and positive 1 to 2 points on core operating income.

第三季度，銷售額將增加 1 個百分點，核心營業收入將增加 1 至 2 個百分點。

And as a reminder, we always update this estimated currency impact on our website on a monthly basis.

提醒一下，我們總是每月更新對我們網站的估計貨幣影響。

And with that, I hand back to Vas.

有了這個，我交還給 Vas。

Thank you, Harry.

謝謝你，哈利。

So moving to the next slide.

所以轉到下一張幻燈片。

When you look at 2021, we have a broad range of catalysts still to go.

當您展望 2021 年時，我們還有大量的催化劑要走。

We've also had good pipeline delivery over the course of the year.

在這一年中，我們也有良好的管道交付。

So we look forward to keeping you updated as we continue to advance these assets and programs.

因此，在我們繼續推進這些資產和計劃的過程中，我們期待為您提供最新信息。

I'd also note, our mid-stage pipeline continues to generate, I think, exciting new innovations, which we hope will emerge and be able to add to our pipeline over the course of the second half.

我還要指出，我認為，我們的中期管道繼續產生令人興奮的新創新，我們希望這些創新能夠出現並能夠在下半年添加到我們的管道中。

Now moving to the last slide, just to close.

現在移動到最後一張幻燈片，只是為了關閉。

As I noted at the beginning, our consistent long-term performance over the recent years is driving our confidence for the future and the continued growth outlook for the company.

正如我在開始時指出的那樣，我們近年來持續的長期表現正在推動我們對未來和公司持續增長前景的信心。

We've had strong performance in Q2, driven by the key growth drivers, as you've seen throughout the presentation.

正如您在整個演示文稿中看到的那樣，在關鍵增長驅動因素的推動下，我們在第二季度取得了強勁的表現。

And we've also continued to advance our pipeline of novel medicines.

我們還繼續推進我們的新藥管道。

You've seen the positive readouts across iptacopan, Lu-PSMA and others.

您已經看到 iptacopan、Lu-PSMA 和其他公司的正面讀數。

And we're reconfirming our full year 2021 guidance, our commitment to drive long-term accretive growth.

我們正在重新確認我們的 2021 年全年指導方針，即我們對推動長期增值增長的承諾。

And again, thank you for your commitment to the company.

再次感謝您對公司的承諾。

And so with that, I'll ask the operator to open the line for questions.

因此，我將要求接線員打開電話以提問。

(Operator Instructions) Your first...

（操作員說明）您的第一個...

And operator, if I could just say one thing.

和接線員，如果我能說一件事的話。

If questioners could limit themselves to 2 questions, we'd appreciate it.

如果提問者可以將自己限制為 2 個問題，我們將不勝感激。

Thank you.

謝謝你。

Your first question today comes from the line of Wimal Kapadia from Bernstein.

您今天的第一個問題來自 Bernstein 的 Wimal Kapadia。

I'm Wimal Kapadia from Bernstein.

我是來自伯恩斯坦的 Wimal Kapadia。

First, I'm just curious how Novartis are thinking about the potential impact of the SGLT2s for Entresto following some of the recent positive data in the preserved ejection fraction population.

首先，我只是好奇諾華公司是如何考慮 SGLT2s 對 Entresto 的潛在影響，這是在保留射血分數人群中最近的一些積極數據之後。

Clearly, these drugs have quite a robust profile and have -- are reasonably well priced, and have demonstrated efficacy on top and in Entresto-naive patients.

顯然，這些藥物具有相當強大的特徵，並且價格合理，並且在頂級和未接受 Entresto 的患者中顯示出療效。

So do you expect to see any impact?

那麼您希望看到任何影響嗎？

I'm just curious on your level of confidence that these drugs will not be used ahead of Enteresto.

我只是好奇你對這些藥物不會在 Enteresto 之前使用的信心程度。

My second question is just on iptacopan.

我的第二個問題只是關於 iptacopan。

Clearly, lots of interesting data recently for the drug across multiple indications.

顯然，最近有許多有趣的數據表明該藥物涉及多種適應症。

But I'm just curious how Novartis is thinking about it from a commercial perspective.

但我只是好奇諾華是如何從商業角度考慮的。

I appreciate this will come down to time lines and which indications demonstrate efficacy in Phase III, but they're quite a different size of markets and competitive dynamics are quite different.

我很欣賞這將歸結為時間線以及哪些跡象表明第三階段的有效性，但它們的市場規模完全不同，競爭動態也完全不同。

So ultimately, how Novartis is going to prioritize, should we see success across multiple indications?

所以最終，諾華將如何優先考慮，我們是否應該看到多個適應症的成功？

Particularly given the acceptable price points by indications could be quite different and competition from the likes of the Apellis could limit the potential.

特別是考慮到跡象表明可接受的價格點可能完全不同，並且來自 Apellis 等公司的競爭可能會限制潛力。

Thanks, Wimal.

謝謝，維馬爾。

So first on the SGLT2s, Marie-France?

那麼首先在 SGLT2s 上，Marie-France？

So thanks for the question.

所以謝謝你的問題。

As you rightly said, the SGLT2s are add-ons.

正如您所說的那樣，SGLT2 是附加組件。

And so we expect them to continue to be used predominantly in diabetes patients.

因此，我們預計它們將繼續主要用於糖尿病患者。

Even if we think about the new readout of PEF, we've really only seen the press release and we'd have to look at the full data because the trials were really quite different.

即使我們考慮 PEF 的新讀數，我們實際上也只看到了新聞稿，我們必須查看完整的數據，因為試驗真的完全不同。

The bottom line is actually Entresto has a unique position, and it's got a broad label in the U.S. that's covering 5 out of 6 patients with chronic heart failure.

底線實際上是 Entresto 具有獨特的地位，它在美國有一個廣泛的標籤，涵蓋了 6 名慢性心力衰竭患者中的 5 名。

We're very strong with the cardiologists.

我們對心髒病專家非常有信心。

And we're going to focus on making sure that 70% of the HFrEF patients who are on previous standard of care switch to Entresto.

我們將專注於確保 70% 的採用先前護理標準的 HFrEF 患者改用 Entresto。

So I think between the compelling data, the strong guideline support that we have, the commercial infrastructure, the excellent team that we have in place, we have what it takes to continue the momentum with Entresto.

因此，我認為在令人信服的數據、我們擁有的強有力的指導方針支持、商業基礎設施、我們擁有的優秀團隊之間，我們擁有繼續推動 Entresto 發展勢頭所需的一切。

And if patients need an add-on, then an SGLT2 is the right thing to do.

如果患者需要附加產品，那麼 SGLT2 是正確的選擇。

And then -- thanks, Marie-France.

然後——謝謝，Marie-France。

And with respect to iptacopan, I think our overall strategy, as you can see, is to fully leverage the unique mechanism and profile of this medicine across the range of indications we've outlined.

關於 iptacopan，我認為我們的總體戰略，如您所見，是在我們概述的適應症範圍內充分利用這種藥物的獨特機制和概況。

Now of course, it will be data-driven and the sequencing will be determined by the data.

當然，現在它將是數據驅動的，排序將由數據決定。

But our goal is, on the one hand, to disrupt existing markets with the fact that we have a safe oral that can be given broadly to patients who, at the moment, are taking at least -- at the moment taking IVs on an ongoing basis.

但一方面，我們的目標是擾亂現有市場，因為我們有一種安全的口服藥物，可以廣泛用於目前至少正在服用靜脈注射藥物的患者——目前正在服用靜脈注射藥物。基礎。

And so we think there's a very attractive profile there.

所以我們認為那裡有一個非常有吸引力的個人資料。

And then to enter into completely new market segments in renal disease, hematological illnesses that currently don't have a very strong standard of care.

然後進入腎臟疾病的全新細分市場，血液疾病目前沒有非常強的護理標準。

And so that's how you're going to see us approach the launch, fully maximize the asset across the full range of numerous indications we're pursuing.

這就是您將看到我們如何接近發布，在我們正在追求的眾多跡像中充分利用資產。

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

您的下一個問題來自美國銀行的 Graham Parry。

So first one is on Kesimpta.

所以第一個是在 Kesimpta。

Just wondering what percentage of drug dispensers free drug in first half and how you expect that to be in second half.

只是想知道上半年有多少百分比的配藥員免費提供藥物，以及您預計下半年會如何。

Because you said you expect demand to double, 2H.

因為你說你預計需求會翻倍，2H。

And I think if you take first half sales and add on twice that, you get to around consensus of $350 million.

而且我認為，如果您將上半年銷售額加上兩倍，您將獲得大約 3.5 億美元的共識。

But if you're getting less free drug, could you actually beat the consensus number?

但如果你得到的免費藥物越來越少，你真的能超過共識數字嗎？

And then secondly, on the NATALEE trial, now that recruitment is complete, can you narrow the window down to when in 2022 we might see the data?

其次，在 NATALEE 試驗中，既然招募已經完成，您能否將窗口縮小到 2022 年我們可能會看到數據的時間？

Even just is that -- do you think it's a first half or a second half event?

甚至只是——你認為這是上半場還是下半場？

Thanks, Graham.

謝謝，格雷厄姆。

On Kesimpta, Marie-France?

在 Kesimpta，Marie-France？

Yes.

是的。

So on Kesimpta, our key focus is really on broad adoption in early lines of therapy.

所以在 Kesimpta 上，我們的重點實際上是在早期治療中的廣泛採用。

And I say that because I think it's really important for our strategy that everyone understand that we want to ensure the value of high-efficacy B-cell therapy early.

我這麼說是因為我認為每個人都明白我們希望儘早確保高效 B 細胞療法的價值對我們的戰略非常重要。

As I said in my opening comments, we have about 500 new prescribers, and we've also got about twice as many patients on Kesimpta's Q1.

正如我在開場評論中所說，我們有大約 500 名新開處方者，而且 Kesimpta 第一季度的患者人數也增加了兩倍。

All patients are starting on free drug.

所有患者都開始服用免費藥物。

And even though our free-to-paid conversion is happening really quickly, there's always a bit of a lag.

儘管我們的免費到付費轉換發生得非常快，但總是有一點滯後。

So in the second half of the year, we know we have the fundamentals in place.

因此，在今年下半年，我們知道我們的基本面已經到位。

We know we still have some scaling to do around familiarity of the brand given that Kesimpta is new in market.

我們知道，鑑於 Kesimpta 是市場上的新產品，我們仍然需要圍繞品牌熟悉度做一些擴展。

And we're going to focus -- we're going to continue our focus on leading share of voice on the differentiation and really on consistently enabling fast and easy initiation.

我們將專注於 - 我們將繼續專注於在差異化方面領先的聲音份額，並真正致力於始終如一地實現快速和輕鬆的啟動。

So for the full year, we're comfortable with external expectations.

因此，對於全年而言，我們對外部預期感到滿意。

We know what we need to do to double demand in Q2 and really deliver a strong Q4.

我們知道我們需要做些什麼才能使第二季度的需求翻倍並真正實現強勁的第四季度。

Medium term, we expect Kesimpta to be a major growth driver for the company.

中期來看，我們預計 Kesimpta 將成為公司的主要增長動力。

Thanks, Marie-France.

謝謝，瑪麗-法蘭西。

And then on NATALEE timing, John?

然後關於 NATALEE 時間安排，約翰？

Yes.

是的。

Thanks for the question, Graham.

謝謝你的問題，格雷厄姆。

On NATALEE, which is our adjuvant study for Kisqali, as we disclosed earlier last year, that we've increased the recruitment from 4,000 to 5,000 patients.

正如我們去年早些時候披露的那樣，在我們對 Kisqali 的輔助研究 NATALEE 上，我們已將招募的患者從 4,000 名增加到 5,000 名。

And this includes both the intermediate and high-risk patients who have had advanced breast cancer.

這包括患有晚期乳腺癌的中危和高危患者。

Our final result that we expect to read out is going to be at the end of next year, and that's how it's currently powered.

我們預計將在明年年底公佈最終結果，這就是它目前的動力。

As we said previously, we're not disclosing interims.

正如我們之前所說，我們不會披露臨時信息。

So we're currently powered for the end of the year next year for our final readout.

因此，我們目前正在為明年年底的最終讀數提供動力。

Your next question comes from Jo Walton from Credit Suisse.

您的下一個問題來自瑞士信貸的 Jo Walton。

My first question is about marketing spend.

我的第一個問題是關於營銷支出。

So we saw in the second quarter of last year, clearly, very little on the sales side and a dramatic constriction of everybody's marketing spend.

因此，我們在去年第二季度清楚地看到，銷售方面很少，而且每個人的營銷支出都在急劇收縮。

And then could you give us some idea of how you've opened that up, what sort of level of your marketing capacity you're at now in the second quarter as you enter the third quarter?

然後你能告訴我們你是如何打開它的，當你進入第三季度時，你現在在第二季度的營銷能力水平如何？

And how you think marketing spend might be able to be sustained at perhaps a lower level going forwards, I don't know, more use of digital or whatever.

以及您如何認為營銷支出可能能夠維持在較低的水平，我不知道，更多地使用數字或其他方式。

But if we can get a sense of whether you feel -- or how confident you are in a reduction in your long-term marketing spend because of all the things that you've learned with COVID.

但是，如果我們能夠了解您是否感覺到 - 或者您對減少長期營銷支出的信心，因為您從 COVID 中學到了所有東西。

And my second question would be to ask for a bit more detail on China.

我的第二個問題是詢問有關中國的更多細節。

You've talked about drugs where you've tripled sales, quadrupled sales.

您談到了銷售額翻了三倍、翻了兩番的藥物。

Can you just give us a little bit of an idea of your level of investment and your level of ambition in China, please?

請您簡單介紹一下您在中國的投資水平和抱負水平嗎？

Yes.

是的。

Thanks, Jo.

謝謝，喬。

So first on marketing spend trends, I'll hand it to Harry.

所以首先關於營銷支出趨勢，我將把它交給哈利。

Harry?

哈利？

Jo.

喬。

So on the marketing spend, it's actually playing out as we guided to early in the year, which is, as you pointed out, quarter 2 spend is quite higher than last year quarter 2, where basically, all major markets were locked down.

因此，在營銷支出方面，它實際上正在按照我們年初的指導進行，也就是說，正如您所指出的，第二季度的支出比去年第二季度的支出要高得多，基本上所有主要市場都被鎖定了。

Maybe other than China, but also in the U.S. So that's why we guided also that, in the first half, we wouldn't see margin improvement.

也許除了中國，還有美國。所以這就是為什麼我們也指導說，在上半年，我們不會看到利潤率提高。

And I think with the sales of 3% and core operating income of 2%, we saw that also playing out.

而且我認為隨著 3% 的銷售額和 2% 的核心營業收入，我們也看到了這一點。

So I would expect continued, especially quarter 3, where also last year's spend levels were low, that marketing and sales growth is at a certain healthy level given the investment needs.

因此，我希望繼續，特別是第三季度，去年的支出水平也很低，鑑於投資需求，營銷和銷售增長處於一定的健康水平。

But of course, within our guidance, be it on our productivity programs, on manufacturing and overall, the expected sales growth that, then in the second half, also as we had more normal, I would say, spend levels in quarter 4 last year, that this plays out.

但是，當然，在我們的指導下，無論是我們的生產力計劃、製造業還是整體預期的銷售增長，然後在下半年，我想說的是，去年第四季度的支出水平更加正常，這會奏效。

And I laid out that in half 2, we will have some very nice margin improvement that leads to the full year guidance of margin improvement.

我指出，在第二年的一半，我們將有一些非常好的利潤率改善，從而導致全年利潤率改善的指導。

Now in the midterm, I do expect that SG&A will be, together with manufacturing productivity on cost of goods, be the major driver of our margin increases, especially Innovate Medicines, to the high 30s.

現在在中期，我確實預計 SG&A 將與製造產品成本的生產力一起，成為我們利潤增長的主要驅動力，尤其是創新藥物，達到 30 多歲。

And certainly, a change in mix somewhat a bit more to virtual, digital; but still face to face in most markets being important, especially for launch initiation.

當然，混合的變化更多的是虛擬的，數字的；但在大多數市場中面對面仍然很重要，特別是對於啟動啟動。

But I would expect that SG&A is one of the major drivers to continue to improve, in the midterm, our margin.

但我預計 SG&A 是在中期繼續提高我們利潤率的主要驅動力之一。

Thanks, Harry.

謝謝，哈利。

And on China, Jo, first to take a step back.

在中國，喬，首先退後一步。

A few years ago, we began an investment effort in China, really putting in the necessary infrastructure both in pharma and oncology, building out sales forces to really enable us to drive longer-term growth.

幾年前，我們開始在中國進行投資，真正在製藥和腫瘤學領域投入必要的基礎設施，建立銷售隊伍，真正使我們能夠推動長期增長。

And then second, we adopted a development strategy to bring our full portfolio of medicines to China, as well as including China in our Phase III programs at the start.

其次，我們採取了一項發展戰略，將我們的全部藥物組合帶到中國，並在一開始就將中國納入我們的 III 期項目。

So that given the changes in the regulatory framework there, that would enable us an earlier launch.

因此，鑑於那裡監管框架的變化，這將使我們能夠更早地推出。

Now fast forward today, we are growing in the high-teens percentages in China overall.

現在快進到今天，我們在中國的整體比例正在以十幾歲的比例增長。

From a business -- we're on track on our stated goal to double the size of our China business from the 2020 baseline.

從業務來看——我們正在實現我們的既定目標，即在 2020 年的基線上將我們的中國業務規模擴大一倍。

We expect to be, if current trends prevail, 1 of the top 3 players amongst multinationals, if not more, in China by 2024, 2025.

如果當前趨勢佔上風，我們預計到 2024 年和 2025 年，我們將成為中國跨國公司前 3 名中的一員，甚至更多。

That's driven primarily by new medicines.

這主要是由新藥推動的。

So overcoming any of the medicines that ultimately get tendered, driving -- our newer portfolio driving the growth.

因此，克服任何最終被招標的藥物，推動我們的新產品組合推動增長。

We have 50 potential approvals in that time frame, continued strong success on the NRDL listings, as you saw with Consentyx.

正如您在 Consentyx 中看到的那樣，我們在該時間範圍內有 50 個潛在的批准，在 NRDL 列表上繼續取得巨大成功。

So we expect China to become the second-largest market for Novartis in the world.

所以我們預計中國將成為諾華在全球的第二大市場。

We see profitable, accretive growth being driven from there, and we'll continue to look to invest prudently in China over the years to come.

我們看到從那裡推動了盈利的、增值的增長，我們將在未來幾年繼續審慎地投資於中國。

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。

I have a couple of questions, please.

我有幾個問題，請。

First on Kisqali and the NATALEE trial.

首先是 Kisqali 和 NATALEE 試驗。

Given the outcome of the PENELOPE-B trial with Ibrance, how comfortable are you that your disease-free survival data that you'll have at the end of next year has significant -- have sufficient duration on it to satisfy the FDA without wanting to see further follow-up?

鑑於與 Ibrance 進行的 PENELOPE-B 試驗的結果，您對明年年底獲得的無病生存數據具有重要意義感到多麼滿意——有足夠的持續時間來滿足 FDA 的要求而不希望看進一步的跟進？

And then second question on business development.

然後是關於業務發展的第二個問題。

We've seen a rash of your competitors doing neurodevelop -- neurodegenerative deals.

我們已經看到你的競爭對手在進行神經發育——神經退行性交易。

You've obviously had the surprising approval of aducanumab.

你顯然已經獲得了令人驚訝的 aducanumab 批准。

How is that influencing your interest in the neurodegenerative space?

這如何影響您對神經退行性空間的興趣？

And then if you could also comment on your Chairman's recent comments of Novartis' interest in mRNA as a platform.

然後，如果您還可以評論一下您的主席最近關於諾華公司對 mRNA 作為平台的興趣的評論。

Yes.

是的。

Thanks, Andrew.

謝謝，安德魯。

On the Kisqali situation, John, do you want to take that?

關於 Kisqali 的情況，約翰，你願意接受嗎？

Sure.

當然。

Thanks for the question, Andrew.

謝謝你的問題，安德魯。

And as we've taken a look, as I said earlier, we've increased the number of patients in our NATALEE trial from 4,000 to 5,000, including both intermediate and high-risk patients.

正如我之前所說，我們已經將 NATALEE 試驗中的患者人數從 4,000 增加到 5,000，包括中度和高風險患者。

As we look at this patient population, there's a couple of things that we focus on.

當我們查看這個患者群體時，有幾件事是我們關注的。

One is we have a longer treatment duration, looking at a duration of 3 years for the overall treatment.

一是我們的治療時間更長，整體治療時間為 3 年。

So that should give us confidence in the approach.

所以這應該讓我們對這種方法充滿信心。

We've also looked at the adherence of patients, particularly in the first year.

我們還研究了患者的依從性，尤其是在第一年。

As we look at these patients, as you know, in the early treatment of these patients, micrometastatic disease is important.

當我們觀察這些患者時，如您所知，在這些患者的早期治療中，微轉移性疾病很重要。

And what we've seen, at least across both arms, is that the patients are adhering and staying on drug at the 400-milligram dose.

我們所看到的，至少在雙臂上，患者堅持服用 400 毫克劑量的藥物。

So with those 2 specific components, we feel comfortable with the readout at the end of next year.

因此，對於這兩個特定組件，我們對明年年底的讀數感到滿意。

Thanks, John.

謝謝，約翰。

And so on business development, we of course are watching the changes in the approach to the use of the accelerated approval pathway.

等等業務發展，我們當然正在關注使用加速審批途徑的方法的變化。

As we've already noted, in neurodegenerative diseases, we have the ongoing program in Huntington's disease entering Phase IIb, and we'll certainly consider how best to potentially bring that forward if there's a way to accelerate regulatory submission, assuming positive clinical trials.

正如我們已經指出的那樣，在神經退行性疾病方面，我們正在進行的亨廷頓氏病項目進入 IIb 期，如果有一種方法可以加速監管提交，假設臨床試驗積極，我們當然會考慮如何最好地推進這一項目。

And then also internally, we've had neurodegeneration efforts within the country for many decades, as you know.

然後在內部，我們已經在國內進行了幾十年的神經退化工作，如你所知。

And we continue to have programs targeting Alzheimer's disease, Huntington's, as well as other neurodegenerative diseases, both using biologics, RNA interference, siRNAs and ASOs as well as gene therapies.

我們繼續有針對阿爾茨海默病、亨廷頓病以及其他神經退行性疾病的項目，均使用生物製劑、RNA 干擾、siRNA 和 ASO 以及基因療法。

So that will continue.

所以這將繼續。

No specific comments on BD&L in the neurodegenerative space.

沒有關於神經退行性疾病領域的 BD&L 的具體評論。

Of course, we are looking, as always, for attractive assets to bring in given our broad-based efforts in neuroscience.

當然，鑑於我們在神經科學領域的廣泛努力，我們一如既往地在尋找有吸引力的資產。

On mRNA.

在 mRNA 上。

Again, not much more to add.

同樣，沒有太多要添加的內容。

I think we've watched how mRNA continues to have value in the COVID space and are curious to see, could mRNA have applicability more broadly within the vaccine space?

我想我們已經看到了 mRNA 如何在 COVID 領域繼續發揮價值，並且很想知道 mRNA 能否在疫苗領域更廣泛地適用？

We have our own ongoing efforts internally, obviously, with inclisiran in manufacturing, for siRNAs with pelacarsen, with antisense oligonucleotides, we're a substantial manufacturer of those technologies.

顯然，我們在內部有自己的持續努力，在製造中使用 inclisiran，對於具有 pelacarsen 的 siRNA，使用反義寡核苷酸，我們是這些技術的重要製造商。

And also have internal efforts on RNA interference.

並且在RNA干擾方面也有內部努力。

So that work will continue.

所以這項工作將繼續下去。

And we'll continue to evaluate if there is any sensible approaches in mRNA more broadly, but nothing imminent at the moment.

我們將繼續評估是否有更廣泛的 mRNA 方法，但目前還沒有。

Your next question comes from the line of Mark Purcell from Morgan Stanley.

您的下一個問題來自摩根士丹利的 Mark Purcell。

Firstly, on Kesimpta.

首先，關於凱辛普塔。

I wondered if you could give us the NBRx share in the U.S. currently.

我想知道你是否可以給我們目前在美國的 NBRx 份額。

And then in terms of thinking about those 13 launches anticipated by the end of 2021, how we should think about the advantages and disadvantages of a subcut formulation for a B-cell therapy in those launch markets outside the U.S.

然後在考慮到 2021 年底預期的 13 次發布方面，我們應該如何考慮在美國以外的那些發布市場中用於 B 細胞療法的亞切製劑的優缺點。

And then secondly on inclisiran, 2 parts.

然後在 inclisiran 上，2 部分。

First part, what are your latest thoughts around FDA site inspection?

第一部分，您對 FDA 現場檢查的最新想法是什麼？

And how should we think about the future supply split between yourselves and a third party?

我們應該如何看待你們自己和第三方之間的未來供應分配？

And then you sort of mentioned these new initiatives, V-INITIATE and V-INCEPTION, which are kicking off now ahead of outcomes data in 2026.

然後你提到了這些新舉措，V-INITIATE 和 V-INCEPTION，它們現在在 2026 年的結果數據之前開始。

Could you elaborate a little bit more on those initiatives and others you are looking to increase the evidence base behind inclisiran before we wait for those outcomes data?

在我們等待這些結果數據之前，您能否詳細說明那些計劃以及您希望增加 inclisiran 背後的證據基礎的其他計劃？

Thanks, Mark.

謝謝，馬克。

So first on Kesimpta subcutaneous outside the U.S., Marie-France?

那麼首先在美國以外的 Kesimpta 皮下，Marie-France？

Yes.

是的。

So Kesimpta is an important launch for us outside of the U.S. And if I just -- if I look at Europe alone, we've got 420,000 patients living with MS and many of these patients are on low-efficacy therapies.

所以 Kesimpta 是我們在美國以外的一個重要推出。如果我只是 - 如果我單看歐洲，我們有 420,000 名 MS 患者，其中許多患者正在接受低效治療。

Actually, many more patients are in low-efficacy therapies versus the U.S.

實際上，與美國相比，更多的患者正在接受低效治療。

So what we also know, we're currently working through reimbursement and to accelerate access.

所以我們也知道，我們目前正在通過報銷和加速訪問。

But what we also know is that a lot of these patients don't have access to infusion centers.

但我們也知道，這些患者中有很多無法進入輸液中心。

So our research tells us that physicians and patients will appreciate a self-administered, high-efficacy therapy that can be used in the comfort of a patient's home.

因此，我們的研究告訴我們，醫生和患者會喜歡一種可在患者家中舒適使用的自我管理的高效療法。

So right now, we're working with each country through their own reimbursement system, and we know what we need to do to bring Kesimpta as quickly as possible to patients around the globe.

所以現在，我們正在通過他們自己的報銷系統與每個國家合作，我們知道我們需要做些什麼來盡快將 Kesimpta 帶給全球患者。

On your NBRx question, currently, our NBRx share in the U.S. is 11%.

關於您的 NBRx 問題，目前，我們在美國的 NBRx 份額為 11%。

And I would also note on Kesimpta, if you look at one case study in the U.K., our ability to get rapid access there, I think, demonstrates the value in ex-U.

我還要注意 Kesimpta，如果你看一下英國的一個案例研究，我認為我們能夠快速進入那裡的能力證明了前美國的價值。

S. markets of the subcutaneous formulation, where the overall cost effectiveness of a therapy is high on the system's mind.

S. 皮下製劑的市場，其中治療的總體成本效益在系統的頭腦中是很高的。

On inclisiran, just on the manufacturing side of things.

在 inclisiran 上，只是在製造方面。

In the U.S., our intention at the moment is to focus production out of our Schaftenau -- Novartis-owned Schaftenau facility.

在美國，我們目前的意圖是將生產集中在我們的 Schaftenau —— Novartis 擁有的 Schaftenau 工廠。

We can't predict on whether or not the FDA will inspect.

我們無法預測 FDA 是否會進行檢查。

It's notable that this site is regularly inspected, has been recently -- this very line has been recently inspected by FDA using a remote inspection and approved for use in a given indication.

值得注意的是，該站點已定期檢查，最近一直 - 這條生產線最近已由 FDA 使用遠程檢查進行檢查，並批准用於給定適應症。

And so we'll have to see what the FDA ultimately determines.

所以我們必須看看 FDA 最終決定什麼。

But I think it's notable that this is a line that's regularly used and inspected by the FDA.

但我認為值得注意的是，這是一條經常被 FDA 使用和檢查的生產線。

And then in terms of the data initiatives, maybe Marie-France, on the efforts to build out data on inclisiran?

然後就數據計劃而言，也許是 Marie-France，關於在 inclisiran 上構建數據的努力？

Yes.

是的。

So I mean, you saw some of that on the slide.

所以我的意思是，你在幻燈片上看到了其中的一些內容。

And obviously, learning from Entresto, we know that we need to build evidence generation.

顯然，從 Entresto 學習，我們知道我們需要建立證據生成。

You know about our efforts on the outcomes data, so ORION-4.

你知道我們在結果數據上的努力，所以 ORION-4。

We're also looking at primary prevention studies.

我們也在研究一級預防研究。

But we're also looking to complement with the V-INITIATE trial.

但我們也在尋求補充 V-INITIATE 試驗。

For example, on the different ways of accessing inclisiran when it comes to acute coronary syndrome or use or no use of ezetimibe.

例如，關於急性冠狀動脈綜合徵或使用或不使用依折麥佈時使用 inclisiran 的不同方式。

So that's the level of evidence and generation that we want to build around the product so that we can ensure fast uptake.

這就是我們希望圍繞產品建立的證據和生成水平，以便我們可以確保快速吸收。

Yes.

是的。

And I just want to add that we continue to work with various important parties.

我只想補充一點，我們將繼續與各個重要方面合作。

So we hope to have updates over the second half of the year on our partnership with the NHS on inclisiran.

因此，我們希望在下半年更新我們與 NHS 在 inclisiran 方面的合作夥伴關係。

That's something we've highlighted in the past.

這是我們過去強調的。

That will be a very important proof point that inclisiran can be used at a large scale in health care systems.

這將是一個非常重要的證據，證明 inclisiran 可以在醫療保健系統中大規模使用。

We're also partnering with major organizations in the United States, such as the American Heart Association, and we hope to announce others, which I think will also demonstrate that we can generate evidence but also generate large-scale utilization volume demand for the medicine.

我們還與美國的主要組織合作，例如美國心臟協會，我們希望宣布其他組織，我認為這也將證明我們可以產生證據，同時也產生對藥物的大規模使用量需求.

So we'll keep you updated as those happen.

因此，我們會在這些情況發生時及時通知您。

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 a question on Sabatolimab, the MDS1 deferral -- effective deferral for PFS readout.

也許是關於 Sabatolimab 的問題，MDS1 延遲 - PFS 讀數的有效延遲。

I think the original fairly long (inaudible) guidance has been for a filing on the CR readout in the second half of this year.

我認為最初相當長（聽不清）的指導是為了在今年下半年提交 CR 讀數。

So what can we interpret on efficacy from that data monitoring decision or recommendation to continue until the PFS readout.

那麼，我們可以從該數據監測決定或建議中解釋什麼，以繼續直到 PFS 讀數。

Unless I'm mistaken, that's a couple of years away.

除非我記錯了，那是幾年後的事了。

So does that impact your guidance around that being potential blockbuster $1 billion-plus indication?

那麼，這是否會影響你對潛在的 10 億美元以上的重磅指標的指導？

And then a question on Zolgensma.

然後是關於 Zolgensma 的問題。

You've given helpful guidance of around 20% newborn screening rates in Europe.

您為歐洲大約 20% 的新生兒篩查率提供了有用的指導。

Does that inflect next year?

明年會有影響嗎？

Or is it going to be a relatively slow incremental build?

還是會是一個相對緩慢的增量構建？

How are you progressing in terms of national level discussions about -- particularly in light of, as you said, presymptomatic data?

你在國家層面的討論方面進展如何——特別是根據你所說的症狀前數據？

And then if I may, just a quick one on the intrathecal.

然後，如果可以的話，就在鞘內註射一個快速的。

It sounds like not much has changed since Q1.

聽起來自第一季度以來沒有太大變化。

I think you said then you had agreement on the trial design, you were waiting for the clinical hold to be lifted.

我想您當時說過您已就試驗設計達成一致，您正在等待解除臨床暫停。

So is it -- are those discussions ongoing?

那麼，這些討論還在進行嗎？

Or has there anything new actually happened in the last few months?

或者在過去的幾個月裡有什麼新的事情發生了嗎？

Yes.

是的。

Thanks, Emmanuel.

謝謝，伊曼紐爾。

So first on the Sabatolimab CR readout, John?

那麼首先在 Sabatolimab CR 讀數上，約翰？

Yes.

是的。

For the sabatolimab, as you know, this is our TIM-3 compound, our first-in-class IO therapy for myelodysplastic syndrome and AML.

如您所知，對於 sabatolimab，這是我們的 TIM-3 化合物，是我們針對骨髓增生異常綜合徵和 AML 的一流 IO 療法。

As we designed the study, we always had 2 primary endpoints.

在我們設計研究時，我們總是有 2 個主要終點。

The first primary endpoint being complete remission and the second endpoint being progression-free survival.

第一個主要終點是完全緩解，第二個終點是無進展生存期。

And as we read out the complete remission, we reached the number of endpoints in the earlier part of this year.

當我們讀出完全緩解時，我們在今年早些時候達到了終點的數量。

At that point, the DMC data monitoring committee came back and told us to continue the study as originally planned.

那時，DMC 數據監測委員會回來告訴我們按原計劃繼續研究。

So you've seen the slide that was shared earlier by Vas in terms of the number of readouts.

所以你已經看到了 Vas 之前分享的關於讀數數量的幻燈片。

As you've seen, we actually look at not only MDS but also AML.

如您所見，我們實際上不僅關注 MDS，還關注 AML。

So as we look at this, we do think that this is a differentiated asset for -- not only for us to think about high-risk MDS, but also AML based on the fact that it has a good safety profile and potentially pending results, the efficacy in terms of durability of response.

因此，當我們看到這一點時，我們確實認為這是一項差異化資產——不僅讓我們考慮高風險 MDS，而且還考慮 AML，因為它具有良好的安全性和潛在的未決結果，反應持久性方面的功效。

So we await the results in 2022 and '23.

因此，我們等待 2022 年和 23 年的結果。

And I think, Emmanuel, as we highlighted, there's multiple different filing options depending on how the results play out.

我認為，Emmanuel，正如我們強調的那樣，有多種不同的提交選項，具體取決於結果如何發揮作用。

And it doesn't change our belief that the medicine given it's a first-in-class asset that has a different mechanism than any existing therapy or late-stage therapy that can be a significant $1 billion-plus medicine.

這並沒有改變我們的信念，即該藥物是一流的資產，其機制不同於任何現有的療法或後期療法，可能是價值超過 10 億美元的藥物。

On Zolgensma, on the incremental NBS and how we're doing on newborn screening, Marie-France, do you want to say a word about that?

關於 Zolgensma，關於增量 NBS 以及我們在新生兒篩查方面的表現，Marie-France，你想談談嗎？

Yes.

是的。

I would just say that -- so you know that in the U.S., the newborn screening is high.

我只想說——所以你知道在美國，新生兒篩查率很高。

Outside the U.S., I mean, it really is a market by market.

在美國以外，我的意思是，這確實是一個逐個市場的市場。

So it's gradual.

所以是循序漸進的。

I mean, I can give you some information.

我的意思是，我可以給你一些信息。

Germany will be implemented by -- from October.

德國將從 10 月開始實施。

We'll see parts of Belgium screening.

我們將看到比利時放映的部分內容。

From the beginning of this year, we know that Poland is implementing gradually.

從今年開始，我們知道波蘭正在逐步實施。

We've got other countries across Europe that are doing this.

我們在歐洲還有其他國家正在這樣做。

So it's a mixed picture.

所以這是一個混合的畫面。

We're very committed to it.

我們非常致力於它。

We know that it's really important to start Zolgensma early.

我們知道儘早開始 Zolgensma 非常重要。

We saw that from the Sprint data and how amazing the results are when babies are treated early.

我們從 Sprint 數據中看到了這一點，以及早期治療嬰兒的結果是多麼驚人。

So it is a priority for us.

所以這對我們來說是一個優先事項。

And then, of course, medium term, our goal is to bring Zolgensma to older children once we get the IT formulation.

然後，當然，從中期來看，我們的目標是在我們獲得 IT 配方後將 Zolgensma 帶給年齡較大的孩子。

And just another word on that, thanks, Marie-France.

再說一句，謝謝，Marie-France。

On the intrathecal, there's no update, Emmanuel, we continue to work through resolving the FDA's concerns.

在鞘內，沒有更新，Emmanuel，我們繼續努力解決 FDA 的擔憂。

But we do have the protocol.

但我們確實有協議。

Finalize agreement with the FDA on the Phase III, design or preparing operationally for the study's execution with the belief that, that indication can continue to be a multibillion-dollar indication for the company.

最終與 FDA 就第三階段達成協議，為研究的執行設計或準備運營，並相信該適應症可以繼續為公司帶來數十億美元的適應症。

And as soon as we have any updates on the preclinical topic and resolution with the FDA, we'll, of course, provide it.

一旦我們對 FDA 的臨床前主題和決議有任何更新，我們當然會提供。

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

您的下一個問題來自 Exane BNP 的 Richard Parkes。

Just 2 questions.

就2個問題。

Firstly, on sales and margins, both your expectations for 2Q that you set out at the 1Q results.

首先，在銷售額和利潤率方面，您在第一季度業績中對第二季度的預期都是如此。

I just wondered if you could discuss what surprised you positively and confident that those trends will continue, given that you haven't updated guidance?

我只是想知道，鑑於您尚未更新指南，您是否可以積極討論讓您感到驚訝的事情並確信這些趨勢將繼續下去？

And I just wondered if you could add your thoughts on impact of the delta variant and maybe whether you've adjusted your planning or solutions for health care systems, opening up on the basis of that?

我只是想知道您是否可以添加您對 delta 變體的影響的想法，也許您是否已經調整了醫療保健系統的計劃或解決方案，並在此基礎上開放？

And then secondly, just a question on some of your legacy oncology assets in the U.S., specifically Promacta, Tasigna and Tafinlar.

其次，只是關於您在美國的一些遺留腫瘤學資產的問題，特別是 Promacta、Tasigna 和 Tafinlar。

If I look at sales per script over the last few quarters, at least in the first half, it looks like sales per script has been growing in double digits, which seems to imply quite significant price increases.

如果我查看過去幾個季度的每個劇本的銷售額，至少在上半年，每個劇本的銷售額似乎都在以兩位數的速度增長，這似乎意味著價格大幅上漲。

I just wondered whether you could discuss that trend and whether there are any other factors such as channel mix that might be impacting that?

我只是想知道您是否可以討論這一趨勢，以及是否有任何其他因素（例如渠道組合）可能會影響這一趨勢？

Thanks, Richard.

謝謝，理查德。

So first on sales and margins outlook, Harry?

那麼首先是銷售和利潤前景，Harry？

Yes.

是的。

The hard -- the line was a bit hard to understand.

難——這條線有點難以理解。

Richard, could you briefly repeat?

理查德，你能簡單重複一下嗎？

Harry, I think the question was, was there anything that surprised us versus the Q -- the guidance we gave after Q1 on how Q2 would play out?

哈利，我認為問題是，與 Q 相比，有什麼讓我們感到驚訝的 - 我們在 Q1 之後給出的關於 Q2 將如何發揮的指導？

And how do we potentially see the delta variant impacting our guidance for the rest of the year?

以及我們如何潛在地看到 delta 變體影響我們在今年餘下時間的指導？

Yes.

是的。

So yes, okay.

所以是的，好吧。

Thank you.

謝謝你。

So Richard, obviously, we delivered a bit more than what we thought, right?

所以理查德，很明顯，我們交付的東西比我們想像的要多，對吧？

So we saw in the U.S. a bit faster reopening, I would say, in most of our brands.

所以我們在美國看到了更快的重新開放，我想說，在我們的大多數品牌中。

Sandoz is pretty much in line with expectation, but our Innovative Medicines, some better momentum overall.

山德士幾乎符合預期，但我們的創新藥物總體勢頭較好。

And then also very good work from our manufacturing colleagues on productivity, in addition to always perfect levels.

除了始終完美的水平之外，我們的製造同事在生產力方面的工作也非常出色。

But overall, I would say, slightly ahead of our internal expectations in quarter 2.

但總的來說，我會說，略高於我們在第二季度的內部預期。

Yes.

是的。

Thanks, Richard.

謝謝，理查德。

I think on the delta variant, we continue to monitor the situation.

我認為在 delta 變體上，我們會繼續監控情況。

What we are expecting is that given that health care systems have seen the impact when they have shut down to patients with noncommunicable diseases and the substantial impact that has, we remain optimistic that health care systems will ensure that patients get the care they need while dealing with any surges that may or may not happen with respect to COVID-19.

我們所期待的是，鑑於衛生保健系統在關閉非傳染性疾病患者時已經看到了影響以及由此產生的重大影響，我們仍然樂觀地認為，衛生保健系統將確保患者在處理疾病時獲得所需的護理與 COVID-19 可能發生或不可能發生的任何激增有關。

Now on Promacta, Taf/Mek, U.S. performance, Susanne?

現在在 Promacta，Taf/Mek，美國表演，Susanne？

Yes.

是的。

Thanks a lot.

非常感謝。

And Richard, on Promacta, actually, we are very, very pleased with the performance.

理查德，在 Promacta 上，實際上，我們對性能非常非常滿意。

As you rightly note, 18% growth, and it's really across all geographies and it is volume driven.

正如您正確指出的那樣，增長了 18%，而且確實遍及所有地區，而且是數量驅動的。

And it's really still our main indications, ITP and SAA.

它仍然是我們的主要適應症，ITP 和 SAA。

To give you a little bit more granularity on the U.S., we had 11% growth.

為了讓您更詳細地了解美國，我們增長了 11%。

And maybe just to remind you, there was a label update earlier this year that makes Promacta even more competitive.

也許只是為了提醒您，今年早些時候的標籤更新使 Promacta 更具競爭力。

We are seeing share gains increasing, NBRx.

NBRx，我們看到股票收益增加。

And of course, it is the efficacy driving that.

當然，這是驅動它的功效。

It's also the oral convenience and is the nonimmunosuppressive benefit over competitors and therefore, a very strong performance.

這也是口服的便利性，並且是對競爭對手的非免疫抑制優勢，因此具有非常強大的性能。

Ex-U.

前U。

S., we saw 26% growth versus previous year.

S.，我們看到與去年相比增長了 26%。

It's very strong underlying performance in major markets like the EU.

它在歐盟等主要市場的潛在表現非常強勁。

And also just to mention very strong performance in China, where we got the RL listing end of last year.

還要提到在中國的非常強勁的表現，我們去年底在中國獲得了 RL 上市。

So very pleased with Promacta.

對 Promacta 非常滿意。

Similar on Tabrecta, we could -- sorry, on Mekinist/Tafinlar, we could really stabilize market share and are very competitive versus new entries.

在 Tabrecta 上類似，我們可以 - 抱歉，在 Mekinist/Tafinlar 上，我們可以真正穩定市場份額，並且與新條目相比非常有競爭力。

Very pleased with the growth, also across geographies.

對增長感到非常滿意，也跨地區。

And also to mention for China, we are very pleased we got Taf/Mek included into the NRDL list.

還要提到中國，我們很高興將 Taf/Mek 納入 NRDL 名單。

So really strong growth on volume base across geographies.

因此，跨地區的銷量增長非常強勁。

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

您的下一個問題來自古根海姆的 Seamus Fernandez。

So just 2 quick ones.

所以只有2個快速的。

As we think about the opportunity in MDS and for the TIM-3 asset, I was just hoping if you could give us a little bit more color on the evolution.

當我們考慮 MDS 和 TIM-3 資產的機會時，我只是希望你能給我們更多關於進化的色彩。

I just wanted to follow up on the previous question.

我只是想跟進上一個問題。

And specifically, as it relates to the CR response there, is that -- your conclusion there that the proceeding to the PFS benefit is a clear positive moving into the subsequent events?

具體來說，當它與那裡的 CR 響應相關時，您的結論是，獲得 PFS 收益是對後續事件的明顯積極影響？

Or is this just a continuation of the trial, which could be viewed as somewhat disappointing on that side of it for the high-risk MDS patient population?

或者這只是試驗的延續，對於高危 MDS 患者群體來說，這可能被視為有點令人失望？

The second question, obviously, you guys are talking quite strongly about the opportunity for asciminib, just in the third-line setting, blockbuster potential.

第二個問題，顯然，你們都在非常強烈地談論 asciminib 的機會，就在三線設置中，一鳴驚人的潛力。

Can you just talk about that relative.

能不能說說那個親戚。

Is that predominantly relative to bosutinib as sort of the primary opportunity and kind of replacing that asset or replacing that product sales?

這是否主要相對於博舒替尼作為替代該資產或替代該產品銷售的主要機會和類型？

Or is it really speaking to a broader opportunity in the third-line setting because of potential for duration of use expanding upon how that product is used so far?

或者它是否真的在談論三線環境中更廣泛的機會，因為使用期限的潛力會擴大該產品迄今為止的使用方式？

Yes, Seamus.

是的，西莫。

So just in the interest of time, on the MDS, I think with the CR readout, I would say neutral to positive.

因此，出於時間考慮，在 MDS 上，我認為對於 CR 讀數，我會說中性到積極。

I mean, neutral is saying because we're blinded, so we don't know what the DMC saw.

我的意思是，中立的意思是因為我們被蒙蔽了，所以我們不知道 DMC 看到了什麼。

But I think the fact that the study will continue now to the next set of endpoints and the positive mechanism that we see in the previous data that we've seen on the product.

但我認為，這項研究現在將繼續到下一組終點，以及我們在之前在產品上看到的數據中看到的積極機制。

We remain optimistic that both in MDS and AML, we can get to positive results and bring meaningful innovation patients.

我們仍然樂觀地認為，無論是在 MDS 和 AML 中，我們都能取得積極成果並帶來有意義的創新患者。

As John noted, the studies have a range of different designs, including a third study that also takes into account venetoclax, a doublet and triplet design.

正如 John 所指出的，這些研究有一系列不同的設計，包括第三項研究，該研究也考慮了 venetoclax、雙聯體和三聯體設計。

So I think we have the bases covered, and we look forward to getting the additional readouts over the coming 1.5 years.

所以我認為我們已經涵蓋了基礎，我們期待在未來 1.5 年內獲得更多讀數。

On the sales potential of asciminib, Susanne, do you want to say a word about this?

關於 asciminib 的銷售潛力，Susanne，您對此有什麼想說的嗎？

Yes, I'm happy to take that, Vas.

是的，我很高興接受這個，Vas。

And maybe just on the opportunity on Sabatolimab, just why we are very excited is because it's a completely novel mechanism.

也許只是在 Sabatolimab 的機會上，我們之所以非常興奮是因為它是一種全新的機制。

It's a TIM-3.

這是 TIM-3。

So has the potential to be the first immuno-oncology therapy in hematology, in MDS and AML.

因此有可能成為血液學、MDS 和 AML 中的第一個免疫腫瘤學療法。

And why we believe that is important is because obviously, there is -- now has been made progress on having more efficacious treatments but what we all know, durability and also safety profile is still remaining challenging.

為什麼我們認為這很重要，因為很明顯，現在已經在進行更有效的治療方面取得了進展，但眾所周知，耐用性和安全性仍然具有挑戰性。

And therefore, we are very excited that Sabatolimab would have this attribute to add really huge value to this medical need.

因此，我們非常高興 Sabatolimab 將具有這一特性，從而為這種醫療需求增加真正巨大的價值。

And on asciminib to maybe lead you a little bit through just to remind you a little bit on the dynamics in CML.

關於 asciminib 可能會引導您了解一下，只是為了提醒您一點 CML 的動態。

So there is still 10% to 15% of patients that progress to third line.

所以仍有 10% 到 15% 的患者進展到三線。

But what you also have to know, there is a significant number of patients that remain in second line just because of lack of options for these patients.

但你也必須知道，有大量患者因為缺乏選擇而留在二線治療。

Moving to third line.

移動到第三行。

What we still see is a 75% failure rate which, of course, is devastating.

我們仍然看到的是 75% 的失敗率，這當然是毀滅性的。

And that's why there is still a big percentage of patients sitting in second line even if treatment is not optimal.

這就是為什麼即使治療不是最佳的，仍有很大比例的患者坐在二線。

So therefore, you see that is the pool we are targeting.

因此，您會看到這就是我們的目標池。

And we also, with asciminib, expect longer duration of the current treatment.

而且，我們還期望使用 asciminib 的當前治療持續時間更長。

So that is where potential comes from.

所以這就是潛力的來源。

And I think we still underestimate the earlier lines potential.

而且我認為我們仍然低估了早期線路的潛力。

Of course, we have changed completely the outcome of CML.

當然，我們已經完全改變了 CML 的結果。

But as I said, in first line, usually, patients are started on imatinib, and there's 50% of patients that relapsed.

但正如我所說，在第一線，通常患者開始使用伊馬替尼，有 50% 的患者復發。

What you also have to know that 30% of first-line patients having issues with adverse events and really are struggling for such a long-term treatment.

您還必須知道，有 30% 的一線患者存在不良事件問題，並且確實在為這樣的長期治療而苦苦掙扎。

And that's where with the profile of asciminib, we expect to also add value there and that's why we're also entering into first line.

這就是 asciminib 的概況，我們希望在那裡也能增加價值，這就是我們也進入第一線的原因。

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

您的下一個問題來自 Berenberg 的 Kerry Holford。

A couple for me, please.

請給我一對。

Harry, just on the second half outlook.

哈利，只是在下半場展望。

You obviously raised the pharmaa form operating profit growth guide in the slide today, but you're not updating the gross guidance for the group.

您顯然在今天的幻燈片中提高了 pharmaa 表格的營業利潤增長指南，但您沒有更新該集團的總指南。

And although you've not changed the outlook for Sandoz, in the second half, what is it within this division that problems continued caution for that second half outlook just by those improvements you've seen in Q2?

儘管您沒有改變 Sandoz 下半年的前景，但由於您在第二季度看到的那些改善，該部門的問題繼續對下半年前景持謹慎態度是什麼？

And then on inclisiran.

然後在inclisiran上。

Just I think a question was asked on this earlier, but just to clarify.

只是我認為之前有人問過這個問題，但只是為了澄清。

What are your plans on the manufacturing of that drug in the future?

您對未來生產這種藥物有什麼計劃？

Can you remind us where the ex-U.

你能提醒我們前U在哪裡嗎？

S. supply is manufactured?

S.供應是製造的？

Should we understand that the global manufacturing sites is now the Austrian site?

我們是否應該理解全球製造基地現在是奧地利基地？

Or should we anticipate further significant investment at some point, perhaps in the U.S.?

或者我們是否應該預計在某個時候會有更多的重大投資，也許是在美國？

Yes.

是的。

Thanks, Kerry.

謝謝，克里。

So first on the Sandoz outlook on the second half, Harry?

那麼首先是關於下半場 Sandoz 的前景，Harry？

Yes.

是的。

Thank you, Kerry.

謝謝你，克里。

So we have to remember how quarter 1 and quarter 2 have developed here.

所以我們必須記住第一季度和第二季度是如何發展的。

So clearly, you saw a very steep decline of quarter 1. And then you saw that 5% growth of Sandoz in the second quarter.

很明顯，您看到了第一季度的急劇下降。然後您看到山德士在第二季度增長了 5%。

But underlying, if you take the prior year is talking about minus 1%.

但從根本上看，如果你拿上一年的話，那就是負 1%。

So we saw as expected a stabilization but we have a first half with a 5% decline.

因此，我們看到了預期的穩定，但上半年下跌了 5%。

So in order to be at the low to mid-single-digit decline in the full year, we continue to expect stabilization around broadly in line for the second half for Sandoz.

因此，為了在全年保持中低個位數的跌幅，我們繼續預計 Sandoz 下半年將大致穩定。

And I think that is, at this moment, a very reasonable assumption.

我認為，目前這是一個非常合理的假設。

Of course, we can all make scenarios around cough and cold and flu season in quarter 4 and the market dynamics for that.

當然，我們都可以圍繞第 4 季度的咳嗽、感冒和流感季節以及市場動態來製作情景。

We have taken the midpoint scenario on this.

我們對此採取了中點方案。

So overall, I would say, of course, volatility given the COVID situation and how the cough and cold season would be.

因此，總的來說，我當然會說，鑑於 COVID 情況以及咳嗽和寒冷季節的情況，波動性很大。

But overall, I would say our guidance is quite, starting from a minus 5% decline in half 1, quite reasonable that Sandoz would stabilize.

但總的來說，我想說我們的指導是相當的，從半年的負 5% 下降開始，山德士會穩定下來是相當合理的。

They have a few first 5 launches in the second half.

他們在下半場進行了幾次前 5 次發射。

So that helps.

所以這有幫助。

We have to see also how the pricing in the U.S. continues to develop.

我們還必須看看美國的定價如何繼續發展。

So I would say not all were overly cautious but realistic.

所以我想說並不是所有人都過於謹慎但現實。

Thanks, Harry.

謝謝，哈利。

And then Kerry, on manufacturing, it's important to note when you take a step back.

然後是克里，在製造方面，當你退後一步時要注意這一點很重要。

Our overall goal is to have Novartis be the primary manufacturing of both the upstream and downstream parts of this siRNA for inclisiran.

我們的總體目標是讓諾華成為 inclisiran siRNA 上游和下游部分的主要製造商。

And we've made the necessary investments to do that.

我們已經為此進行了必要的投資。

We have substantial manufacturing capacity to synthesize the siRNA.

我們有強大的製造能力來合成 siRNA。

And then as we've noted, we -- in the U.S., we'll move to using our facility.

然後正如我們所指出的，我們 - 在美國，我們將開始使用我們的設施。

And over time, globally, the primary manufacturing will be done out of Novartis facilities, being supplemented by CMOs as needed.

隨著時間的推移，在全球範圍內，初級製造將在諾華工廠之外完成，並根據需要由 CMO 補充。

The primary reason to do this is, one, we believe the medicine will be, as we've noted, one of our most significant medicines.

這樣做的主要原因是，我們相信，正如我們所指出的，這種藥物將是我們最重要的藥物之一。

And then second, from a COGS standpoint, our goal is to drive significantly down the cost of goods to enable large-scale use of the medicine in the secondary prevention study and eventually perhaps in the primary prevention study.

其次，從 COGS 的角度來看，我們的目標是顯著降低商品成本，以便在二級預防研究以及最終可能在一級預防研究中大規模使用該藥物。

Right now, ex-U.

現在，前U。

S., we do use third parties for both the primary and the secondary.

S.，我們確實使用第三方作為主要和次要的。

But again, over time, the evolution will be the Novartis owned facilities.

但同樣，隨著時間的推移，演變將是諾華擁有的設施。

And those investments have already been either started or completed.

這些投資已經開始或完成。

Your next question comes from Peter Welford from Jefferies.

您的下一個問題來自 Jefferies 的 Peter Welford。

Just 2, please.

請只有2個。

Firstly, on oncology.

首先，關於腫瘤學。

Just looking at some of the hospital-administered drugs, in particular, and also some of those that require either biomarker diagnostic -- companion diagnostics to use, it actually looks as though the second quarter for some of those drugs is sort of relatively weak compared to the first quarter.

只看一些醫院管理的藥物，特別是一些需要生物標誌物診斷的藥物——伴隨診斷，實際上看起來其中一些藥物的第二季度相對較弱到第一季度。

There certainly wasn't sort of an uptick.

肯定沒有上升趨勢。

I'm thinking the likes of Kymriah and Lutathera, for instance.

例如，我在想像 Kymriah 和 Lutathera 這樣的人。

Also as well, I think things like even to break and other drugs.

同樣，我認為甚至打破和其他藥物之類的事情。

I wonder if you could just comment on what you're seeing there with regards to why I guess we're not seeing Q-on-Q improvements in oncology and how we should think about that perhaps in the second half of the year and the gating factors?

我想知道你是否可以評論一下你在那裡看到的內容，為什麼我猜我們沒有看到腫瘤學的 Q-on-Q 改進，以及我們應該如何考慮可能在下半年和門控因素？

And then secondly, I just want to come back to Harry's comments that we could reach the higher end of the outlook ranges that COVID situation remains fluid.

其次，我只想回到哈里的評論，即我們可以達到 COVID 形勢仍然不穩定的前景範圍的高端。

Should we take that to mean that if COVID situation pans out as we currently see, the higher end of the range is where we should be thinking?

我們是否應該認為這意味著如果 COVID 情況像我們目前看到的那樣發展，那麼我們應該考慮範圍的高端？

Or should we take that as thinking that you just don't know, and you still see uncertainty?

還是我們應該認為你只是不知道，你仍然看到不確定性？

I guess curious sort of where you're thinking with regards to the current COVID situation and whether the situation has to deteriorate significantly for that to be not valid?

我想您對當前的 COVID 情況以及情況是否必須顯著惡化才能使其無效？

Thanks, Peter.

謝謝，彼得。

So just briefly Susanne, on the hospital administered oncology.

簡單介紹一下醫院腫瘤科的 Susanne。

Yes.

是的。

Thank you, Vas, and thank you, Peter, for the question.

謝謝你，Vas，謝謝你，彼得，這個問題。

So as I mentioned in my presentation, these areas that you mentioned hospital-initiated areas but also, of course, where you have new launches, this is still impacted by COVID, especially when you look at the U.S. that only 75% of patients are back versus pre-COVID levels.

因此，正如我在演講中提到的，您提到的這些領域是醫院發起的領域，當然還有新推出的領域，這仍然受到 COVID 的影響，尤其是當您看到美國祇有 75% 的患者是與 COVID 之前的水平相比。

So we still like a 1/4 or 1/4 of patients volume that we usually saw.

所以我們仍然喜歡我們通常看到的患者數量的 1/4 或 1/4。

And that is impacting, for example, diagnostics, it's impacting screening.

這正在影響，例如，診斷，它正在影響篩查。

And that's, of course, Tabrecta would be such a brand where you see lower biopsies, you see lower testing REIT rates overall.

當然，Tabrecta 就是這樣一個品牌，您會看到較低的活組織檢查，您會看到整體較低的測試 REIT 率。

I have to say when you look within the ones that are tested, Tabrecta and testing for cMET is increasing, but it's just suppressed patient volumes.

我不得不說，當你查看那些被測試的人時，Tabrecta 和對 cMET 的測試正在增加，但它只是抑制了患者數量。

And this is same, what we see for hospital-initiated product.

這也是一樣的，我們在醫院推出的產品中看到的。

Just to give you some figures on Kymriah, as I said, 19% versus previous year.

正如我所說，只是給你一些關於 Kymriah 的數據，與去年相比，增長了 19%。

But we saw that especially in the U.S. The whole class saw a reduced demand.

但我們看到，尤其是在美國，整個班級的需求減少了。

And while we stay very competitive with Kymriah,and that is really linked to recent also manufacturing success rate that customers are very pleased about, it's really the demand that we saw in the whole class going down.

雖然我們與 Kymriah 保持很強的競爭力，這與最近客戶非常滿意的製造成功率有關，但我們看到整個班級的需求確實在下降。

And on Lutathera, there is some early positive signs in the U.S. We have seen growth versus previous year as some now referrals are started, but it's still very, very suppressed.

在 Lutathera 上，美國有一些早期的積極跡象。我們看到了與去年相比的增長，因為現在開始了一些推薦，但它仍然非常非常受到抑制。

And we remain confident that with now the market opening up centers, taking more patients in, this should improve and accelerate.

我們仍然相信，隨著現在市場開放中心，接納更多患者，這應該會得到改善和加速。

Yes.

是的。

Thanks, Susanne.

謝謝，蘇珊。

And then Peter, on the outlook, as Harry noted, it's multiple dynamics, of course, we're monitoring.

然後彼得，就前景而言，正如哈利指出的那樣，這是多種動態，當然，我們正在監控。

But if the business dynamics continue as we currently see them, if oncology can continue its recovery, if Sandoz remains in a stable situation, given the strong growth we're seeing in our growth drivers, there's certainly the potential for us to be at the higher end of the guidance.

但是，如果業務動態像我們目前看到的那樣繼續下去，如果腫瘤學能夠繼續復甦，如果 Sandoz 保持穩定的情況，鑑於我們在增長驅動力方面看到的強勁增長，那麼我們肯定有可能處於指導的高端。

And we'll, of course, keep you updated in quarter 3.

當然，我們會在第 3 季度為您提供最新信息。

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。

First question is on Leqvio, please.

第一個問題是關於 Leqvio，請。

Have you dosed any patients in the U.K. under your program there yet?

你有沒有在英國根據你的計劃給任何病人服用過藥物？

I think you said the program was starting this quarter.

我想你說這個項目是從這個季度開始的。

And what setting will those early doses be given?

那些早期劑量將被給予什麼設置？

And are these patients being seen in the hospital?

這些患者是否在醫院接受治療？

Or have you managed to get it into primary care from the word go?

還是您從一開始就設法將其納入初級保健？

And then second question is just on Entresto.

然後第二個問題只是關於 Entresto。

Could you maybe talk a little bit about the uptake in the past population?

你能談談過去人口的吸收嗎？

Yes.

是的。

Thanks, Laura.

謝謝，勞拉。

So first on Leqvio, the agreement, we're still working through the final stages with the NHS.

因此，首先關於 Leqvio 協議，我們仍在與 NHS 合作完成最後階段。

So we have not yet dosed patients in the U.K. The agreement, though has the aspiration that this would be rolled out in primary care from day 1 at scale, trying to address the ASCVD population and get the U.K. towards its long-term goal in cardiovascular health.

所以我們還沒有在英國給患者服用該協議，儘管希望從第一天開始在初級保健中大規模推廣，試圖解決 ASCVD 人群並讓英國實現其在心血管疾病方面的長期目標健康。

So we -- hopefully, we'll have updates in the coming months on that pioneering initiative, which we hope will catalyze Leqvio's global impact over the coming years.

因此，我們希望在未來幾個月內獲得有關這一開創性舉措的最新信息，我們希望這將促進 Leqvio 在未來幾年的全球影響力。

On Entresto (inaudible), and I'll just start taking the questions given the time Entresto, (inaudible).

關於 Entresto（聽不清），我將在 Entresto 時間開始回答問題（聽不清）。

We do see, I think, the uptake already, and you can see that in the NBRx, but it's still early days.

我認為，我們確實已經看到了這種吸收，你可以在 NBRx 中看到這一點，但現在還處於早期階段。

And I think as we continue the rollout in the education as well as the awareness on the guidelines, we would expect to see continued growth for Entresto.

我認為，隨著我們繼續推廣教育以及提高對指導方針的認識，我們預計 Entresto 將繼續增長。

We see a strong outlook for the brand.

我們看到了該品牌的強勁前景。

We're confident we'll be in that $4 billion to $5 billion range.

我們有信心我們將在 40 億至 50 億美元的範圍內。

And as we continue to see the trajectory, we'll provide further updates on the long-term outlook for Entresto in the coming months.

隨著我們繼續看到這一軌跡，我們將在未來幾個月內提供有關 Entresto 長期前景的進一步更新。

Your next question comes from Tim Anderson from Wolfe Research.

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

Thinking about bimekizumab, they've gotten some good exposure recently with publication of their data in the New England Journal.

考慮到 bimekizumab，他們最近在《新英格蘭雜誌》上發表了他們的數據，從而獲得了很好的曝光率。

Beats your product on efficacy, has a one side effect of oral candidiasis.

在功效上擊敗您的產品，具有口腔念珠菌病的一種副作用。

How much do you think this product will impact Consentyx?

您認為這款產品會對 Consentyx 產生多大影響？

And do you think that one side effect is a material impairment to their product in your view?

在您看來，您認為其中一個副作用是對他們的產品造成實質性損害嗎？

And then on tislelizumab, your partnered PD-1, how realistically will we compete in a setting like lung in Western markets?

然後在與您合作的 PD-1 tislelizumab 上，我們將如何在西方市場像肺這樣的環境中競爭？

Can you and your partner assure us you won't be disruptive on price?

您和您的合作夥伴能否向我們保證您不會在價格上造成乾擾？

I ask because U.S. (inaudible) for price erosion over time in the category, I'm wondering who's going to be driving that?

我問是因為美國（聽不清）隨著時間的推移該類別的價格侵蝕，我想知道誰將推動這一點？

Yes.

是的。

So first on Cosentyx.

所以首先在 Cosentyx 上。

When you look at the dynamics, we've been able to take on competition consistently over the recent years, continue to grow the brand double digit, as Marie-France said, to 20% plus.

當您查看動態時，我們已經能夠在最近幾年中始終如一地進行競爭，如 Marie-France 所說，繼續將品牌兩位數增長到 20% 以上。

That's driven both in dermatology and in rheumatology.

這在皮膚病學和風濕病學中都受到了推動。

We know the additional competitors coming in.

我們知道有更多的競爭對手進來。

I can't comment specifically on bimekizumab, but we do think that Consentyx' very clean safety profile, the fact that it's used in such a broad range of dermatology offices and consistently across patient types, its ability to address scalp, palmoplantar psoriasis as well as the joint manifestations and the fact that we have additional indications, we're not concerned by additional IL-17 entrants.

我不能具體評論 bimekizumab，但我們確實認為 Consentyx 非常乾淨的安全性，它被用於如此廣泛的皮膚科辦公室並且始終如一地跨越患者類型的事實，它也能夠解決頭皮、掌蹠銀屑病作為聯合表現和我們有其他跡象的事實，我們並不擔心額外的 IL-17 進入者。

And really our focus now given that we've been able to effectively hold price in the U.S. market despite some disruptive attempts.

考慮到儘管進行了一些破壞性嘗試，我們仍然能夠有效地控制美國市場的價格，因此我們現在真正關注的是。

We are confident now that our focus has to be on the next wave of indications to drive this brand well beyond the $5 billion benchmark we've already put out there.

我們現在有信心，我們的重點必須放在下一波跡像上，以推動這個品牌遠遠超過我們已經提出的 50 億美元的基準。

On tislelizumab, you've seen the esophageal cancer filing.

在 tislelizumab 上，您已經看到了食管癌備案。

We're moving towards first and second-line non-small cell lung cancer.

我們正在走向一線和二線非小細胞肺癌。

We do believe that the -- we are able to market this medicine from a competitive standpoint, given our long presence, particularly outside the U.S., but also in the U.S. We'll be prudent in how we think about the pricing, but we do think we can make a compelling value proposition.

我們確實相信 - 我們能夠從競爭的角度銷售這種藥物，因為我們長期存在，特別是在美國以外，而且在美國我們會謹慎考慮定價，但我們會認為我們可以提出令人信服的價值主張。

Longer term, real opportunity for us is in combination.

從長遠來看，對我們來說真正的機會在於結合。

We'll be taking forward tislelizumab in combination with our SHP2 inhibitor in combination with some of our RLT agents, amongst other opportunities.

我們將推進 tislelizumab 與我們的 SHP2 抑製劑與我們的一些 RLT 藥物的組合，以及其他機會。

And so we're going to work to both maximize on the combination side as well as take as much as we can of a very large PD-1 market given the broad range of indications we expect the agent to have.

因此，鑑於我們期望該代理具有廣泛的跡象，我們將努力在組合方面最大化並儘可能多地佔據一個非常大的 PD-1市場。

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。

Two, please, if I may.

兩個，請，如果可以的話。

Just going back to Leqvio.

只是回到Leqvio。

I wonder if you could give us some idea of the ramp to 300,000 patients given the unusual situation you have there, having not only agreed reimbursement but also utilization?

我想知道您是否可以給我們一些關於 300,000 名患者的斜坡的想法，因為您那裡的情況不尋常，不僅同意報銷而且還同意使用？

And then secondly, moving on to Sandoz.

其次，轉到 Sandoz。

Harry, you gave the principal drivers for expansion of the IM margin over time.

Harry，你給出了隨著時間的推移擴大 IM 保證金的主要驅動因素。

I wonder if you could do the same for the Sandoz margin?

我想知道您是否可以為 Sandoz 保證金做同樣的事情？

Yes.

是的。

Thanks, Simon.

謝謝，西蒙。

So for Leqvio in the U.K., it's going to be driven by our ability to work with the U.K. to get primary care physicians to diagnose these patients out of the MS data systems and then rapidly get them on to Leqvio.

因此，對於英國的 Leqvio 而言，這將受到我們與英國合作的能力的推動，讓初級保健醫生從 MS 數據系統中診斷出這些患者，然後迅速讓他們使用 Leqvio。

I think it will be a slow initial ramp, and then we hope to see a rapid ramp-up.

我認為這將是一個緩慢的初始增長，然後我們希望看到快速增長。

In the U.S., we've done a very good job of targeting the relevant integrated health systems to hopefully be prepared to have a reasonable uptake initially.

在美國，我們在針對相關綜合衛生系統方面做得非常好，希望能夠為最初的合理吸收做好準備。

But again, it will take time to get those centers on board.

但同樣，讓這些中心參與進來還需要時間。

In parallel, we'll also have a traditional launch with our traditional sales and marketing approach, leveraging the Entresto field force and reach.

與此同時，我們還將通過傳統的銷售和營銷方法進行傳統的發布，利用 Entresto 的現場力量和影響力。

So on approval in the U.S., we'll go very -- obviously, out very strongly.

因此，在美國獲得批准後，我們將非常 - 顯然，非常強烈地退出。

It will take time to get the brand up.

品牌提升需要時間。

And then once we think we get momentum, we expect the brand as we've guided to, to be a very significant multibillion-dollar medicine for the company.

然後，一旦我們認為我們獲得了動力，我們預計我們所引導的品牌將成為公司價值數十億美元的非常重要的藥物。

Midterm Sandoz margins will be driven by a portfolio shift with the biosimilars portfolio, large number of biosimilars in the mid-20s.

中期 Sandoz 的利潤率將受到生物仿製藥組合的投資組合轉變的推動，20 年代中期有大量生物仿製藥。

We expect to get forward, get into the market and some of the first-in-class first hopefully, to markets such as natalizumab, amongst others.

我們希望繼續前進，進入市場，並希望一些一流的產品首先進入 natalizumab 等市場。

And then on top of that, the ability to launch additional injectables and oral solids, while continuing to drive down cost of goods.

最重要的是，能夠推出額外的注射劑和口服固體，同時繼續降低商品成本。

So you'll have a mix shift to higher-margin products as well as the continued efficiency gains and cost of goods.

因此，您將混合轉向更高利潤的產品以及持續的效率提升和商品成本。

And then lastly, Richard and team are working hard to optimize the manufacturing and sales set of leveraging digital technologies.

最後，Richard 和團隊正在努力優化利用數字技術的製造和銷售組合。

And I think that will be the other element that will help us get to those mid- to high 20s margins in Sandoz.

我認為這將是幫助我們在 Sandoz 達到 20 多歲的中高利潤率的另一個因素。

Your next question comes from Steve Scala from Cowen.

您的下一個問題來自 Cowen 的 Steve Scala。

I have 2 questions.

我有 2 個問題。

First, on AVXS-101.

首先，關於 AVXS-101。

Can any findings from the preclinical intrathecal safety studies be shared with us today?

今天可以與我們分享臨床前鞘內安全性研究的任何結果嗎？

So that's the first question.

所以這是第一個問題。

And then on the second question relates to the Kisqali adjuvant interim look in NATALEE.

然後第二個問題與 NATALEE 中的 Kisqali 輔助臨時外觀有關。

I'm curious if this look has already occurred?

我很好奇這種外觀是否已經出現？

If it has, then it would seem to be a material update and you would have announced it.

如果有，那麼它似乎是一個重大更新，你會宣布它。

So I assume that it has not yet occurred, but please confirm.

所以我假設它還沒有發生，但請確認。

Yes.

是的。

Thanks, Steve.

謝謝，史蒂夫。

On AVXS-101 IT, the preclinical data we've seen to date do not indicate any concerns.

在 AVXS-101 IT 上，我們迄今為止看到的臨床前數據並未表明任何擔憂。

However, we need to complete the relevant assessments.

但是，我們需要完成相關的評估。

And of course, ultimately agree with FDA and the listing of clinical hold.

當然，最終同意 FDA 和臨床持有的上市。

And so we'll keep you updated as that progresses.

因此，我們會在進展過程中及時通知您。

The NATALEE interim has not occurred.

NATALEE 過渡期尚未發生。

But as we've guided to, we're no longer guiding to interim analysis timings and we're focusing on the final outcomes.

但正如我們所指導的那樣，我們不再指導中期分析時間，而是關注最終結果。

John, as you mentioned earlier in the call, we expect that to be in the back half of next year.

約翰，正如你之前在電話會議中提到的，我們預計會在明年下半年。

And of course, as we learn more in that study, we'll keep you updated.

當然，隨著我們在該研究中了解更多信息，我們會及時通知您。

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 2, please.

請只有2個。

In the U.K., we recently seen increased structure hospitals partly due to COVID and partly because of (inaudible).

在英國，我們最近看到結構醫院有所增加，部分原因是 COVID，部分原因是（聽不清）。

We've seen electives and oncology appointments being delayed as a result.

我們已經看到選修課和腫瘤科的預約因此被推遲。

Are you seeing early signs or anything similar in the U.S. as you go into a few states where hospitalizations are rising pretty quickly?

當您進入一些住院人數迅速上升的州時，您是否在美國看到了早期跡像或類似情況？

I'm just wondering whether or not that have you seen early signs of that in the U.S.

我只是想知道你是否在美國看到了這種情況的早期跡象。

And secondly, on asciminib.

其次，關於 asciminib。

Do you expect's food interaction to be flat on the label given to the earlier studies?

您是否希望與早期研究的標籤上的食物相互作用持平？

And how do you expect that to be up especially with (inaudible) price probably than the market launch.

以及您如何期望價格會上漲，尤其是（聽不清）價格可能比市場推出的價格高。

Yes.

是的。

Thanks, Naresh.

謝謝，納雷什。

On the U.S., we currently don't see any shifts in utilization or better notable, other than what we already stated in the call, oncology is below pre-COVID levels.

在美國，除了我們在電話會議中已經說明的情況外，我們目前沒有看到利用方面的任何變化或更明顯的變化，腫瘤學低於 COVID 之前的水平。

Cardiovascular is also below pre-COVID levels.

心血管也低於 COVID 之前的水平。

So Entresto continues to have very strong performance and patients with heart failure seem to be getting the medicine as expected.

因此，Entresto 繼續具有非常強勁的表現，心力衰竭患者似乎按預期獲得了藥物。

So nothing that we can flag at this point and also the clinical trials are enrolling on time.

因此，我們目前無法標記任何內容，而且臨床試驗也正在按時註冊。

So we have learned a lot about managing -- I think the health care systems have learned a lot about managing COVID.

所以我們在管理方面學到了很多——我認為醫療保健系統在管理 COVID 方面學到了很多。

We've learned a lot of them managing our trials and the uptake of our medicines during COVID.

我們已經了解到他們中的很多人在 COVID 期間管理我們的試驗和服用我們的藥物。

So Hopefully, we can navigate this next period successfully, but certainly something we're watching very, very closely.

所以希望我們能夠成功地度過下一個時期，但肯定是我們正在非常非常密切地關注的事情。

I think it's too soon to comment on specifics on asciminib's label.

我認為現在評論 asciminib 標籤的細節還為時過早。

I would note that the safety profile was remarkably clean.

我會注意到安全配置文件非常乾淨。

When you look at the -- it was a head-to-head study versus bosutinib across all relevant safety markers.

當您查看 - 這是一項針對所有相關安全性標記的博舒替尼的頭對頭研究。

It was a very clean profile patient stayed on drug.

這是一個非常乾淨的病人，他一直在服藥。

So we're optimistic that overall, the asciminib profile will be attractive, which is a part of the reason as well as Susanne mentioned, we're quite confident that if it ultimately proves superior can be a very effective first-line therapy.

因此，我們樂觀地認為，總體而言，asciminib 的概況將具有吸引力，這也是 Susanne 提到的部分原因，我們非常有信心，如果它最終被證明是一種非常有效的一線療法。

Your next question comes from Martial Descoutures from ODDO BHF.

您的下一個問題來自 ODDO BHF 的 Martial Descoutures。

I would like to come back on the Sandoz business, and thank you for your previous answer on the H2.

我想回到 Sandoz 業務，並感謝您之前對 H2 的回答。

We understand the next step with the top line improvement driven by the pipeline with biosimilars and the section of complete generics.

我們了解生物仿製藥管道和完整仿製藥部分推動的頂線改進的下一步。

But could you share with us your vision on the improvement of the ratability in midterm?

但是您能否與我們分享您對提高中期可評級性的看法？

Do you see any concrete operation or leverage on the cost or due to the improvement of the top line expected and the affiliated cost plus the price erosion.

您是否看到任何具體的成本操作或槓桿作用，或者由於預期收入和相關成本的提高加上價格侵蝕。

Should we consider stabilization of this activity for the next year, if you could give us more color maybe to help us to manage the core EBIT margin in the next quarters and years?

我們是否應該考慮在明年穩定這項活動，如果您能給我們更多的色彩，也許可以幫助我們管理未來幾個季度和幾年的核心息稅前利潤率？

Martial, I fully picked up the question, but I'll give my best answer.

Martial，我完全接受了這個問題，但我會給出最好的答案。

So when you look at Sandoz evolution over time from a margin standpoint.

因此，當您從利潤的角度來看山德士隨時間的演變時。

First, right now, our goal is to invest and create a very strong pipeline performance, in this period of time, both biosimilars and oral solids.

首先，現在，我們的目標是在這段時間內投資並創造一個非常強大的管道性能，包括生物仿製藥和口服固體。

So in the coming years, you're not going to see big shifts in the margin or the operating leverage.

因此，在未來幾年，您不會看到利潤率或經營槓桿發生重大變化。

But our belief is, given Richard is driving very strong efficiency gains across all the relevant P&L items, and we continue to expect important pipeline delivery in biosimilars in respiratory and oral solids.

但我們的信念是，鑑於 Richard 在所有相關損益表項目中推動了非常強勁的效率提升，我們繼續期待呼吸和口服固體生物仿製藥的重要管道交付。

When that pipeline delivery happens, then we expect the margin in the midterm to be accretive and move up into that mid- to high 20s.

當管道交付發生時，我們預計中期利潤率將增加並上升到 20 年代中期至高水平。

So the shape is going to be stable for the period, next few years, and then we expect acceleration in margin improvement for Sandoz as that portfolio ultimately comes through.

因此，在接下來的幾年裡，形狀將保持穩定，然後我們預計隨著該投資組合的最終實現，山德士的利潤率將加速提高。

So I think that's the best way to think about it.

所以我認為這是最好的思考方式。

And I think that was the -- we have one more question, operator.

我認為那是 - 我們還有一個問題，接線員。

So operator, could we go to the last question?

那麼操作員，我們可以轉到最後一個問題嗎？

Your last question today comes from Keyur Parekh from Goldman Sachs.

您今天的最後一個問題來自高盛的 Keyur Parekh。

Vas, if I may.

瓦斯，如果可以的話。

Your (inaudible) comments on Sandoz, talking about the strategic vision in the long term, almost like setting the narrative for a 2022 decision on the longer-term outlook for Sandoz.

您對 Sandoz 的（聽不清）評論，談到了長期的戰略願景，幾乎就像為 Sandoz 的長期前景設定 2022 年決定的敘述一樣。

Am I overinterpreting your comments?

我是否過度解讀了你的評論？

Or is that the time frame in which we should expect a broad decision on whether Sandoz is a part of Novartis and not longer term?

還是我們應該在這個時間範圍內就 Sandoz 是否是諾華的一部分而不是長期做出廣泛決定？

That's question number one.

這是第一個問題。

And then question number two, we are getting very close to on an annualized basis, kind of the peak sales numbers you provided for Cosentyx and kind of Entresto.

然後是第二個問題，我們非常接近您為 Cosentyx 和 Entresto 提供的年度銷售數字。

So I'm wondering kind of why we haven't seen updated kind of peak sales estimates for those 2 products.

所以我想知道為什麼我們沒有看到這兩種產品的更新峰值銷售估計。

Is there anything from a competitive or market perspective that worries you?

從競爭或市場的角度來看，有什麼讓您擔心的事情嗎？

Or was this just not the right opportunity for to -- for you to address the longer-term peak opportunity for those products?

或者這只是你解決這些產品的長期高峰機會的正確機會？

Thanks, Keyur.

謝謝，凱爾。

Good to hear from you.

很高興聽到你的消息。

On Sandoz, there's no updates or changes.

在 Sandoz 上，沒有更新或更改。

I mean, our goal right now is to put Sandoz in a strong position to invest in the business so that it can be on a track to be the leading generics company in the world, which we think it can be from a financial as well as impact standpoint.

我的意思是，我們現在的目標是讓山德士在投資業務方面處於有利地位，使其能夠成為世界領先的仿製藥公司，我們認為它可以來自財務和影響的立場。

If and when we take any decisions or start a process, we'll, of course, let you know.

如果我們做出任何決定或啟動流程，我們當然會通知您。

But right now, our focus is on the operational performance of Sandoz and supporting Richard and his team to driving that mid-single-digit growth and margin expansion that we've outlined.

但現在，我們的重點是山德士的運營業績，並支持理查德和他的團隊推動我們概述的中個位數增長和利潤率擴張。

I think on your second question, I think we are very pleased with the trajectory of Entresto and Cosentyx.

我認為關於您的第二個問題，我認為我們對 Entresto 和 Cosentyx 的發展軌跡感到非常滿意。

You are correct if we're approaching the sales outlook of $4 billion to $5 billion we guided to in Entresto, and $5 billion plus in Cosentyx.

如果我們正在接近我們在 Entresto 和 Cosentyx 中指導的 40 億至 50 億美元的銷售前景，那麼您是正確的。

Our current plan is that meet the management will provide an updated outlook on both of those brands, especially as we understand better the dynamics.

我們目前的計劃是，與管理層會面將為這兩個品牌提供更新的前景，特別是當我們更好地了解動態時。

But certainly, would want to highlight we are confident in both of those brands to be very strong pillars of Novartis in the years to come.

但可以肯定的是，我們有信心這兩個品牌將在未來幾年成為諾華的強大支柱。

So thanks, everyone, for joining today's conference call.

非常感謝大家參加今天的電話會議。

Apologies we ran a bit over.

抱歉，我們跑了一點。

We'll keep you updated.

我們會及時通知您。

Thank you for the interest in the company.

感謝您對公司的關注。

And please stay safe and healthy, and we look forward to speaking soon.

請保持安全和健康，我們期待著盡快發言。

Thank you.

謝謝你。

Thank you.

謝謝你。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for participating.

感謝您的參與。

You may now disconnect.

您現在可以斷開連接。