Novartis AG (NVS) 2020 Q2 法說會逐字稿

Good morning, good afternoon, and welcome to the Novartis Q2 2020 Results Release Conference Call and Live Audio Webcast.

早上好，下午好，歡迎來到諾華 2020 年第二季度業績電話會議和現場音頻網絡直播。

(Operator Instructions) The conference is being recorded.

（操作員說明）正在錄製會議。

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

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

(Operator Instructions)

（操作員說明）

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

至此，我想向投資者關係全球主管 Samir Shah 先生匯報。

Please go ahead, sir.

請繼續，先生。

Thank you very much.

非常感謝。

And thank you to all the participants for taking the time to join us today for our quarter 2 and first-half yearly results for Novartis.

並感謝所有參與者今天抽出時間與我們一起了解諾華第二季度和上半年的年度業績。

Before we start, I just wanted to read you the safe harbor statement.

在我們開始之前，我只是想給你讀一下安全港聲明。

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

今天提供的信息包含涉及已知和未知風險、不確定性和其他因素的前瞻性陳述。

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

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

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 表格及其最新的 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。

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

有了這個，我將轉交給我們的首席執行官 Vas。

Thank you, Samir, and thanks, everyone, for joining today's conference call.

謝謝你，薩米爾，謝謝大家參加今天的電話會議。

With me today, I have Harry Kirsch, our Chief Financial Officer; Marie-France Tschudin, our President of Novartis Pharmaceuticals; Susanne Schaffert, the President of Novartis Oncology; John Tsai, our Head of Global Drug Development and Chief Medical Officer; Richard Saynor, our CEO of Sandoz; and Shannon Klinger, our Chief Legal Officer.

今天和我在一起的還有我們的首席財務官 Harry Kirsch； Marie-France Tschudin，我們的諾華製藥總裁； Susanne Schaffert，諾華腫瘤學總裁；我們的全球藥物開發主管兼首席醫療官 John Tsai；山德士首席執行官 Richard Saynor；和我們的首席法務官 Shannon Klinger。

So moving to Slide 5, overall, we had a strong start to the year with a strong H1 performance when you look at it despite the impact of COVID-19.

因此，轉到幻燈片 5，總體而言，儘管受到 COVID-19 的影響，但當您查看它時，我們在今年的開局表現強勁，上半年表現強勁。

We believe the first-half results are more representative of performance as largely the Q1 forward purchasing reversed out in Q2.

我們認為上半年業績更能代表業績，因為第一季度的遠期採購在第二季度大部分逆轉。

Looking at our first-half performance, you see sales grew at 6%, core operating income at 19%.

看看我們上半年的業績，你會看到銷售額增長了 6%，核心營業收入增長了 19%。

And this underlying performance, I think, demonstrates the overall agility and resilience of the organization.

我認為，這種潛在的表現展示了組織的整體敏捷性和彈性。

When you look at our ability to deliver innovation in the quarter, a few highlights I would like to note.

當您查看我們在本季度提供創新的能力時，我想指出一些亮點。

First, Tabrecta received its approval in non-small cell lung cancer.

首先，Tabrecta 在非小細胞肺癌方面獲得了批准。

This will be an important addition to our portfolio of targeted cancer therapies.

這將是我們靶向癌症治療產品組合的重要補充。

Cosentyx received U.S. and EU approval for non-radiographic axial SpA as well as a number of other approvals around the world, continuing our effort to expand Cosentyx across a range of indications and continuing our long-term trajectory of strong growth with the brand.

Cosentyx 獲得了美國和歐盟對非放射軸向 SpA 的批准以及世界各地的許多其他批准，繼續努力將 Cosentyx 擴展到一系列適應症，並繼續我們與該品牌強勁增長的長期軌跡。

And Marie-France will cover that a bit more in the future slides.

Marie-France 將在未來的幻燈片中對此進行更多介紹。

Zolgensma received EU approval with a broad label for IV SMA therapy.

Zolgensma 獲得了歐盟批准，具有廣泛的 IV SMA 治療標籤。

Beovu, we had a label update with respect to the recent reports of retinal vasculitis and retinal vein occlusion.

Beovu，我們對最近關於視網膜血管炎和視網膜靜脈阻塞的報告進行了標籤更新。

The label update was modest and, I think, reflects the fact that we continue to see a strong benefit/risk profile for Beovu.

標籤更新是適度的，我認為，反映了我們繼續看到 Beovu 強大的收益/風險狀況的事實。

And then lastly, notably, we had 5 simultaneous approvals in Japan, enabling us to set up Japan for our next wave of innovation and growth.

最後，值得注意的是，我們在日本同時獲得了 5 項批准，使我們能夠在日本建立下一波創新和增長。

I did want to note we have been continuing our robust pandemic response, both in terms of human capital safety of our associates and our ability to supply for patients and third parties.

我確實想指出，我們一直在繼續我們強有力的大流行應對措施，無論是在我們員工的人力資本安全方面，還是我們為患者和第三方提供服務的能力方面。

Our supply chain operations remain very stable.

我們的供應鏈運營保持非常穩定。

Customer service levels are at record high, and we're very pleased with our overall manufacturing performance.

客戶服務水平創歷史新高，我們對我們的整體製造業績感到非常滿意。

With our investments in data science and digital technologies, we've been able to manage and disrupt -- minimize any disruptions on clinical trials.

通過我們在數據科學和數字技術方面的投資，我們已經能夠管理和破壞——最大限度地減少對臨床試驗的任何破壞。

And I think, overall, we're very pleased with our ability to maintain our clinical trial timelines.

我認為，總的來說，我們對維持臨床試驗時間表的能力感到非常滿意。

And then lastly, we continue our efforts both on Phase III pivotal studies with canakinumab and ruxolitinib as well as 35 investigator-initiated trials covering over 20 Novartis medicines currently in the clinic.

最後，我們繼續努力開展卡那單抗和魯索替尼的 III 期關鍵研究，以及 35 項研究人員發起的試驗，涵蓋目前臨床上的 20 多種諾華藥物。

And lastly, we announced last week a COVID-19 access portfolio for 15 medicines in 79 low-income and low middle income countries with a goal to have no profit for the distribution of those medicines.

最後，我們上周宣布了針對 79 個低收入和中低收入國家的 15 種藥物的 COVID-19 獲取組合，目標是使這些藥物的分銷不盈利。

Turning to Slide 6, as you saw in our press release, our growth drivers continued their strong momentum.

轉向幻燈片 6，正如您在我們的新聞稿中看到的那樣，我們的增長動力繼續保持強勁勢頭。

Notably, Entresto had a very strong first half of the year.

值得注意的是，Entresto 今年上半年表現非常強勁。

Zolgensma is continuing to grow well, and I'll talk about that in a bit more detail.

Zolgensma 繼續發展良好，我將更詳細地討論這一點。

Cosentyx also had a strong quarter despite the challenging dynamics in the dermatology market.

儘管皮膚病學市場充滿挑戰，但 Cosentyx 的季度表現也很強勁。

Marie-France will cover that in more detail.

Marie-France 將更詳細地介紹這一點。

And then in oncology, Kisqali, Kymriah and Tafinlar + Mekinist all, I think, demonstrated very strong growth profiles, which Susanne will cover later on in the presentation.

然後在腫瘤學方面，我認為 Kisqali、Kymriah 和 Tafinlar + Mekinist 都表現出非常強勁的增長概況，Susanne 將在稍後的演講中介紹。

Taken together, you look on the right side of the slide, our growth drivers and launches now constitute 47% of our Innovative Medicines sales, which I think demonstrates we're well set up for the future.

總而言之，您看幻燈片的右側，我們的增長動力和發布現在占我們創新藥物銷售額的 47%，我認為這表明我們為未來做好了準備。

Now going to Slide 7, when you look at Zolgensma, we had $205 million sales in the quarter, and that growth was driven primarily by geographic expansion.

現在轉到幻燈片 7，當您查看 Zolgensma 時，我們在本季度的銷售額為 2.05 億美元，而這一增長主要是由地域擴張推動的。

And just to go into a little bit more detail into the dynamics, in the U.S., we have about 60% of newborns being screened for SMA as of the end of Q2; strong Medicaid access, 86% of lives now covered with a permanent J code in place.

為了更詳細地了解動態，在美國，截至第二季度末，我們約有 60% 的新生兒接受了 SMA 篩查；強大的 Medicaid 訪問權限，現在 86% 的人都擁有永久的 J 代碼。

I think we did see some COVID-related disruptions in both April and May, given the hospital-based infusion of Zolgensma, but we did see a recovery in the second half of June and the July dynamics are, again, positive, back on the trend that we would expect.

我認為我們確實在 4 月和 5 月看到了一些與 COVID 相關的中斷，考慮到基於醫院的 Zolgensma 輸注，但我們確實看到了 6 月下半月的複蘇，而且 7 月的動態再次積極，回到我們預期的趨勢。

In Europe, we received a broad label conditional approval.

在歐洲，我們獲得了廣泛的標籤有條件批准。

We have a Day One access program in place in many key markets, including in Germany, where we had agreements with 90% of the sick funds in the country as well as early access programs in the remainder of Europe.

我們在包括德國在內的許多主要市場都制定了第一天訪問計劃，在那裡我們與該國 90% 的患病基金以及歐洲其他地區的早期訪問計劃達成了協議。

This enabled us to get off to a very strong start in Europe in the quarter.

這使我們能夠在本季度在歐洲取得非常強勁的開局。

We're very pleased with that.

我們對此非常滿意。

Even just having an approval really in late May, we already saw a strong uptake in Europe.

即使在 5 月下旬才真正獲得批准，我們已經看到歐洲的強勁吸收。

And then our Japan launch has exceeded expectations, fast uptake in the first month of launch.

然後我們在日本的發布超出了預期，在發布的第一個月就被迅速吸收了。

And we continue to see requests from other preapproved market countries with -- through the named patient IND program.

我們繼續看到來自其他預先批准的市場國家的請求——通過指定的患者 IND 計劃。

So overall, a strong global dynamic now for Zolgensma.

總體而言，Zolgensma 現在擁有強大的全球動力。

Now in terms of the regulatory and other milestones for the AVXS-101 IT partial clinical hold, we had a type A meeting with FDA and a very positive dialogue.

現在，就 AVXS-101 IT 部分臨床持有的監管和其他里程碑而言，我們與 FDA 進行了 A 型會議並進行了非常積極的對話。

FDA is open to either a 6-month or a 1-month (sic) [1-year] data readout in our nonhuman primate study.

在我們的非人類靈長類動物研究中，FDA 對 6 個月或 1 個月（原文如此）[1 年] 的數據讀數持開放態度。

We have taken the decision to go to the 1-year readout of the nonhuman primate study just to ensure that we have a very robust data package so that when we move to a hopeful filing in next year, we'll have the best possible data to support our filing.

我們已決定對非人類靈長類動物研究進行為期 1 年的讀數，以確保我們擁有一個非常強大的數據包，以便在明年提交有希望的文件時，我們將擁有最好的數據支持我們的申請。

We plan a pre-BLA meeting this year.

我們計劃今年召開一次 BLA 前會議。

A pre-BLA meeting can be held while on clinical hold.

臨床保留期間可以舉行 BLA 前會議。

And assuming these meetings and discussions and ultimately, the nonhuman primate data is positive, we would plan to submit a BLA in 2021.

假設這些會議和討論以及最終非人類靈長類動物的數據是積極的，我們計劃在 2021 年提交 BLA。

In terms of geographical expansions, we have a number of approvals expected in the second half of 2020 as well as in early 2021.

在地域擴張方面，我們預計將在 2020 年下半年和 2021 年初獲得多項批准。

You can see the countries listed here.

您可以查看此處列出的國家/地區。

And we continue as well to progress our manufacturing efforts, including the expected plants in Colorado and North Carolina coming online in 2021.

我們還將繼續推進我們的製造工作，包括科羅拉多州和北卡羅來納州的預期工廠將於 2021 年上線。

So overall, Zolgensma on a positive track.

所以總的來說，Zolgensma 處於積極的軌道上。

We are positive on the outlook and looking forward to keeping you up to date.

我們對前景持積極態度，並期待讓您了解最新情況。

Now moving to Slide 8, on Sandoz, our first-half results really highlight continuing good performance.

現在轉到 Sandoz 的幻燈片 8，我們上半年的業績確實突出了持續的良好表現。

When you look at it in Q1, we had some significant effects of stocking, which largely reversed in Q2, but the underlying performance of the business was solid with 1% sales growth and 26% core operating income growth when you look at the first half in total.

當你在第一季度看它時，我們有一些顯著的庫存效應，在第二季度基本逆轉，但當你看上半年時，業務的基本表現是穩定的，銷售額增長 1%，核心營業收入增長 26%總共。

Some important performance drivers, including Biopharmaceuticals growing at 25% as well as good gross margin improvement and ROS improvement over this period of time.

一些重要的業績驅動因素，包括生物製藥增長 25%，以及這段時間內毛利率的良好改善和 ROS 的改善。

So we look forward for the second half.

所以我們期待下半場。

Of course, it remains a volatile environment in the generics industry, but we remain confident that Sandoz is well positioned for the remainder of 2020.

當然，仿製藥行業的環境仍然不穩定，但我們仍然相信山德士在 2020 年剩餘時間內處於有利地位。

And then moving to Slide 9 and taking a bit of a step back, I think it's important, despite the, I think, significant focus on COVID-19 and the impacts on our business, to keep the longer term in view.

然後轉到幻燈片 9 並退後一步，我認為重要的是，儘管我認為重點關注 COVID-19 及其對我們業務的影響，但要保持長遠的眼光。

And when you look at Novartis overall, strong in-market growth drivers, significant number of major launches ongoing, a solid portfolio of novel assets in a range of new indications.

當你從整體來看諾華時，強勁的市場增長動力、大量正在進行的重大產品發布、一系列新適應症的穩固的新資產組合。

In summary, 15 ongoing launches, 80 major submissions planned to 2022 and 50 late-stage programs, and this collection of assets is why we have such a strong view that we can maintain solid growth well into the coming years.

總而言之，到 2022 年將有 15 個正在進行的發布、80 個主要提交項目和 50 個後期項目，而這些資產集合是我們如此強烈地認為我們可以在未來幾年保持穩健增長的原因。

And I wanted to take a moment just to give the community -- investor community an update on both our late-stage pipeline and our mid-stage pipeline.

我想花點時間向社區——投資者社區介紹我們的後期管道和中期管道的最新情況。

So moving to the next slide, when you look at our late-stage pipeline, just to go through some of the key assets in detail, ofatumumab, we continue to have very good discussions with FDA.

所以轉到下一張幻燈片，當您查看我們的後期管道時，只是為了詳細了解一些關鍵資產，ofatumumab，我們繼續與 FDA 進行非常好的討論。

We're on track for our action date in September of 2020, no major issues.

我們在 2020 年 9 月的行動日期步入正軌，沒有重大問題。

And happy to, of course, answer any questions, but we feel very good about where we are in that discussion and in the ongoing label negotiation.

當然，很高興回答任何問題，但我們對我們在討論和正在進行的標籤談判中所處的位置感到非常滿意。

With respect to inclisiran, our U.S. and EU submissions are complete.

關於 inclisiran，我們在美國和歐盟提交的文件是完整的。

The review is on track.

審查正在進行中。

As far as we know right now, all the manufacturing reviews are happening on time, and we maintain an FDA action date of December 2020.

據我們目前所知，所有製造審查都按時進行，我們維持 FDA 的行動日期為 2020 年 12 月。

BYL719 in PROS, which is a more rare disease, but I think a very important medicine for this rare disease.

PROS中的BYL719，這是一種比較罕見的疾病，但我認為對於這種罕見的疾病來說非常重要的藥物。

We have a real-world evidence Phase II ongoing, and we submit -- expect a submission in the second half of 2020, which will enable us to continue the momentum for that medicine.

我們有一個真實的第二階段證據正在進行，我們提交——預計在 2020 年下半年提交，這將使我們能夠繼續這種藥物的發展勢頭。

Tafinlar + Mekinist with spartalizumab, our PD-1 inhibitor, a triplet in BRAF-mutant melanoma, we're on track for the Phase III readout also in 2020 and expect a submission if the data is positive as well before the end of the year.

Tafinlar + Mekinist 與我們的 PD-1 抑製劑斯巴達珠單抗，BRAF 突變黑色素瘤的三聯體，我們也有望在 2020 年進行 III 期讀數，如果數據為陽性，預計在年底前提交.

Asciminib, our ABL001 allosteric inhibitor of the BCR-ABL for third-line CML, pivotal study is on track for a readout in 2020 with a first submission in Q1 '21.

Asciminib 是我們用於三線 CML 的 BCR-ABL 的 ABL001變構抑製劑，關鍵研究有望在 2020 年進行讀數，並在 21 年第一季度首次提交。

With canakinumab, our enrollment is complete, and we have both the first-line and second-line studies now moving towards important milestones.

有了 canakinumab，我們的註冊已經完成，我們的一線和二線研究現在都在朝著重要的里程碑邁進。

The first-line study will have a DMC interim analysis in Q4 2020 for both PFS and OS.

一線研究將在 2020 年第四季度對 PFS 和 OS 進行 DMC 中期分析。

There is also an additional interim next year with the final readout expected towards the end of next year.

明年還有一個額外的過渡期，預計將在明年年底公佈最終結果。

And of course, the decision-making with respect to the status of that program will depend on the data.

當然，有關該程序狀態的決策將取決於數據。

CANOPY-2 will have its final readout in the start of next year in second-line non-small cell lung cancer.

CANOPY-2 將於明年年初在二線非小細胞肺癌中獲得最終結果。

With our PSMA asset, Lu-PSMA-617, the VISION Phase III trial, we've recently done an updated review of the pace of event accumulation.

借助我們的 PSMA 資產 Lu-PSMA-617，VISION III 期試驗，我們最近對事件積累的速度進行了更新審查。

And those events are accruing at a slower rate than we initially projected.

這些事件的發生速度比我們最初預計的要慢。

That is leading for us to now predict a readout in the first half of 2021 and a filing as well in that timeframe.

這導致我們現在預測 2021 年上半年的讀數以及該時間範圍內的文件。

Because this is an event-driven trial, we'll continue to monitor this closely and keep the market up to date as we see the events unfold.

因為這是一個事件驅動的試驗，我們將繼續密切關注這一點，並在我們看到事件展開時保持市場最新。

Entresto in HFpEF, the HFpEF indication is now filed.

Entresto 在 HFpEF 中，現在已提交 HFpEF 指示。

The PARADISE-MI enrollment is complete.

PARADISE-MI 註冊已完成。

We expect FDA action on the HFpEF indication in the first half of next year, and we expect the PARADISE results as well in '21.

我們預計 FDA 將在明年上半年對 HFpEF 適應症採取行動，我們預計 PARADISE 也將在 21 年取得結果。

And then ligelizumab, our anti-IgE monoclonal antibody for CSU, both superiority studies versus Xolair are ongoing and on track for readout and submission in 2021.

然後是我們用於 CSU 的抗 IgE 單克隆抗體 ligelizumab，與 Xolair 的優勢研究正在進行中，並有望在 2021 年讀出和提交。

And lastly, Kisqali in the adjuvant breast cancer setting, we continue to progress towards the NATALEE Phase III readout, which we expect in 2022, both with intermediate and high-risk patients, where we believe we have a unique study design and a unique opportunity to bring a broad label to this indication as well as the MONALEESA-2 OS readout in 2021.

最後，Kisqali 在輔助乳腺癌環境中，我們繼續朝著 NATALEE III 期讀數前進，我們預計在 2022 年，無論是中高危患者，我們相信我們擁有獨特的研究設計和獨特的機會為該指示以及 2021 年的 MONALEESA-2 OS 讀數帶來廣泛的標籤。

Now moving to Slide 11, some of the emerging pipeline assets that we've discussed in our recent R&D Day continue to progress as well.

現在轉到幻燈片 11，我們在最近的研發日討論的一些新興管道資產也在繼續取得進展。

And I think many of these assets are underappreciated.

而且我認為其中許多資產都被低估了。

LNP023, our factor B inhibitor, is being developed in a range of renal diseases as well as PNH.

我們的 B 因子抑製劑 LNP023 正在開髮用於治療一系列腎臟疾病以及 PNH。

The single PNH pivotal trial will -- we expect to start in 2020 as well as the full range of renal studies as well in 2021.

單一的 PNH 關鍵試驗將——我們預計將於 2020 年開始，全面的腎臟研究也將在 2021 年開始。

Remibrutinib, our BTK inhibitor, which we believe has a truly unique profile in terms of its overall chemistry, is progressing well in both CSU and Sjögren's disease.

Remibrutinib 是我們的 BTK 抑製劑，我們認為它在整體化學方面具有真正獨特的特徵，在 CSU 和 Sjögren 病中都取得了良好的進展。

Iscalimab, our anti-CD4 (sic) [anti-CD40] monoclonal antibody, also progressing well in kidney transplant and is on track.

Iscalimab 是我們的抗 CD4 (sic) [抗 CD40] 單克隆抗體，在腎移植方面也取得了良好的進展，並且正在步入正軌。

We hope for a regulatory submission in '23 as we negotiate a unique endpoint for that study.

我們希望在 23 年提交監管文件，因為我們為該研究協商了一個獨特的終點。

TQJ, our first-in-class antisense oligonucleotide targeting Lp(a), is continuing to progress well in its outcome study, and we're on track for a readout in 2024.

TQJ 是我們針對 Lp(a) 的一流反義寡核苷酸，在其結果研究中繼續取得良好進展，我們有望在 2024 年進行讀數。

And then 3 oncology assets which we recently highlighted: MBG in -- our anti-TIM-3 monoclonal antibody in MDS as well as in AML; LXH, our B/C-RAF inhibitor, which we're progressing; and TNO, our SHP2 inhibitor, are all progressing rapidly into pivotal stage studies.

然後是我們最近強調的 3 個腫瘤學資產： MBG in——我們在 MDS 和 AML 中的抗 TIM-3 單克隆抗體； LXH，我們正在研發的 B/C-RAF 抑製劑；我們的 SHP2 抑製劑 TNO 正在迅速進入關鍵階段研究。

I would note we have a significant effort to accelerate LXH and TNO as well as a number of other early-stage oncology assets where we look now to take our molecules more quickly into pivotal studies, and we look forward to keeping you up to speed on that progress.

我要指出，我們在加速 LXH 和 TNO 以及許多其他早期腫瘤學資產方面做出了重大努力，我們現在希望將我們的分子更快地用於關鍵研究，我們期待著讓您跟上進度那個進步。

So I hope that gives you a sense of the strength and the scale and breadth of our portfolio and pipeline and gives you confidence that we have all the assets we need for long-term growth.

因此，我希望這能讓您了解我們的投資組合和管道的實力、規模和廣度，並讓您相信我們擁有長期增長所需的所有資產。

And with that, I'll hand it over to Harry -- oh, sorry, I have one more slide.

有了這個，我會把它交給哈利——哦，對不起，我還有一張幻燈片。

My apologies.

我很抱歉。

We have one more important update, which is progressing on our journey of building trust with society.

我們還有一個重要的更新，它正在我們與社會建立信任的旅程中取得進展。

So as you saw over the course of the quarter, we were able to resolve a number of our long-standing legacy legal matters.

因此，正如您在本季度中看到的那樣，我們能夠解決一些長期存在的遺留法律問題。

I won't go through all of them, but I think it's important to note these primarily related to events between 2002 and 2015.

我不會介紹所有這些，但我認為重要的是要注意這些主要與 2002 年至 2015 年之間的事件有關。

Since that time, we've put in place a number of important efforts that we've outlined to all of you: our code of ethics; our enterprise risk management approach; having a Trust & Reputation Committee; a new head of Ethics, Risk & Compliance; as well as a robust set of activities around governance, which you can see here.

從那時起，我們已經做出了一些向大家概述的重要努力：我們的道德準則；我們的企業風險管理方法；有一個信任和聲譽委員會；新任道德、風險與合規主管；以及圍繞治理的一組強大的活動，您可以在此處查看。

This is starting to be reflected as well in the ESG ratings.

這也開始反映在 ESG 評級中。

I will note that Sustainalytics has upgraded our rating from -- in terms of their risk scores and in terms of their overall score from -- in the risk area from 30 to a little less than 21, which puts us at the top end of our pharma peer group.

我會注意到，Sustainalytics 已將我們的評級從風險評分和總體評分從風險領域的 30 分提高到略低於 21 分，這使我們處於領先地位製藥同行組。

I would encourage investors to ensure your ESG analysts are up to speed on the latest data from Sustainalytics, and we'll continue to work with the other ESG agencies to properly reflect the efforts Novartis is making.

我鼓勵投資者確保您的 ESG 分析師及時了解 Sustainalytics 的最新數據，我們將繼續與其他 ESG 機構合作，以正確反映諾華所做的努力。

And with that, I'll hand it over to Harry.

有了這個，我會把它交給哈利。

Yes.

是的。

Thank you, Vas.

謝謝你，瓦斯。

Good morning, good afternoon, everybody.

大家早上好，下午好。

I'm now going to walk you through some of the financials for the second quarter and the first half as well as provide an update on our full-year guidance.

我現在將向您介紹第二季度和上半年的一些財務狀況，並提供我們全年指導的最新信息。

My comments refer to results of our continuing operations, and growth rates are in constant currencies, unless otherwise noted.

我的評論是指我們持續經營的結果，除非另有說明，否則增長率以不變貨幣計算。

So on Slide 14, you see the summary of our Q2 and first-half continuing operations performance.

因此，在幻燈片 14 上，您可以看到我們第二季度和上半年持續運營業績的摘要。

I will focus on the first half as this is the better indicator of our underlying performance as we saw Q1 forward purchasing largely reverse in quarter 2.

我將專注於上半年，因為這是我們基本業績的更好指標，因為我們看到第一季度的遠期購買在第二季度大幅逆轉。

The first half was strong with sales growing 6%, driving core operating income and EPS growth of 19%.

上半年表現強勁，銷售額增長 6%，推動核心營業收入和每股收益增長 19%。

Sales growth was mainly driven, as Vas laid out, by Entresto, Zolgensma and Cosentyx.

正如 Vas 所述，銷售增長主要由 Entresto、Zolgensma 和 Cosentyx 推動。

And core operating income growth was driven by the higher sales and productivity, particularly in gross margin, and partly offset by some launch investments.

核心營業收入增長是由較高的銷售額和生產力推動的，特別是在毛利率方面，但部分被一些啟動投資所抵消。

Net income, as you can see here, grew slower than operating income as it was impacted by slightly higher tax rates and higher net financial expenses due to the acquisition of The Medicines Company in quarter 1. Free cash flow grew 3% to $5.7 billion in the half year, and I will give a bit more detail on that later in the presentation.

正如您在此處看到的，淨收入的增長速度低於營業收入，因為受到第一季度收購 The Medicines Company 導致的稅率略高和淨財務費用增加的影響。自由現金流增長 3% 至 57 億美元半年，我將在稍後的演示文稿中提供更多細節。

Next, let's focus on core margins on Slide 15, again broken down both by quarter and first half.

接下來，讓我們關注幻燈片 15 的核心利潤率，再次按季度和上半年細分。

The first-half sales of 6% plus productivity and savings have resulted in a significant increase in our core margins, as you can see here.

如您在此處看到的，上半年銷售額 6% 加上生產力和節省導致我們的核心利潤率顯著增加。

For Innovative Medicines, in the first half margin was 36.5%, up 2.8 percent points versus prior year.

對於創新藥物，上半年利潤率為 36.5%，比上年增長 2.8 個百分點。

Sandoz significantly grew margins by almost 5 points to 24.5%, driven by a favorable product and geographic mix as well as ongoing productivity improvements.

在有利的產品和地域組合以及持續的生產力提高的推動下，山德士的利潤率顯著增長了近 5 個百分點至 24.5%。

Please consider in your modeling that our second-half margin tends to be somewhat lower than the first half, mainly due to higher spending patterns in the fourth quarter.

請在您的模型中考慮，我們下半年的利潤率往往比上半年略低，主要是由於第四季度的支出模式較高。

Clearly, we are very well on track to deliver a mid-30s margin this year and mid- to high 30s margin in the midterm.

顯然，我們非常有望在今年實現 30 多歲的利潤率，並在中期實現 30 多歲的中高利潤率。

If we now turn to Slide 16, so many of you have asked us about the impact that COVID-19 has had on the therapeutic areas we work in.

如果我們現在轉到幻燈片 16，那麼你們中的許多人都向我們詢問了 COVID-19 對我們工作的治療領域的影響。

We wanted to describe to you in some detail what we are seeing in our business.

我們想向您詳細描述我們在業務中看到的情況。

So the key message is that most therapeutic areas were somewhat impacted at the start of Q2, as you can see here, the gray shaded area, but the magnitude of that impact was quite different.

因此，關鍵信息是，大多數治療領域在第二季度開始時都受到了一些影響，正如您在此處看到的灰色陰影區域，但影響的程度卻大不相同。

COVID affected demand most notably on Lucentis and mature ophthalmology, where we saw also in quarter 2 of this year about 0.3 billion lower sales versus quarter 2 of last year.

COVID 對 Lucentis 和成熟眼科的需求影響最為顯著，我們在今年第二季度也看到，與去年第二季度相比，銷售額減少了約 3 億美元。

Of course, new prescription starts requiring hospital administration were also impacted, which is reflected in some of the growth rates by brand.

當然，需要醫院管理的新處方開工也受到影響，這反映在一些品牌的增長率上。

Now on Slide 16, we showed the Innovative Medicines' weekly sales evolution based on a rolling 4-week average, just to take some of the variability out but show the trends, indexed back to quarter 4 weekly sales of 2019.

現在在幻燈片 16 上，我們展示了創新藥物基於 4 週滾動平均值的每週銷售演變，只是為了消除一些可變性，但顯示趨勢，索引回 2019 年第 4 季度的每週銷售。

We have divided this up in the few different categories which we believe is helpful as they describe the different behaviors.

我們將其分為幾個不同的類別，我們認為這些類別對描述不同的行為很有幫助。

First, the recent launches, then the growth drivers excluding Cosentyx, which we show separately on the slide.

首先是最近的發布，然後是除 Cosentyx 之外的增長動力，我們在幻燈片上單獨展示。

And then we group Beovu, Lucentis and Xiidra altogether.

然後我們將 Beovu、Lucentis 和 Xiidra 組合在一起。

And we have other sort of more mature ophthalmology products.

我們還有其他種類更成熟的眼科產品。

So our recent launches and key growth drivers excluding Cosentyx, which are here shown by the lines of blue and black, did see a bit of an impact on sales growth at the beginning of the quarter but they remained quite resilient and by early May, were continuing to grow again.

因此，我們最近推出的產品和除 Cosentyx 以外的主要增長驅動因素（此處以藍色和黑色線條顯示）確實在本季度初對銷售增長產生了一些影響，但它們仍然相當有彈性，到 5 月初，繼續再次增長。

Cosentyx, here the line in orange, also saw a decline in sales at the start of the quarter and another dip in June, but is now normalizing in the second half of June.

Cosentyx（此處為橙色線）在本季度初的銷售額也出現下滑，6 月份再次下滑，但現在在 6 月下半月恢復正常。

In fact, Cosentyx increased U.S. market share in both dermatology and rheumatology, so outgrew the market.

事實上，Cosentyx 增加了美國在皮膚科和風濕科的市場份額，因此增長超過了市場。

The ophthalmology portfolio, shown here in the gray and green lines, so a bit more at the bottom, was the most affected with a significant impact on sales at the start of the quarter.

眼科產品組合（此處以灰線和綠線顯示，底部略多一點）受到的影響最大，對本季度初的銷售產生重大影響。

Importantly, we have seen it rebound with levels beginning to return to quarter 4 weekly sales averages by the end of Q1.

重要的是，我們已經看到它反彈，到第一季度末，水平開始回到第 4 季度的每周平均銷售量。

I think that's also quite important for our full-year outlook.

我認為這對我們的全年展望也很重要。

Generally, we do not anticipate the COVID-related sales decline of Q2 and after to continue as we are seeing this recovery.

一般來說，我們預計第二季度及之後與 COVID 相關的銷售下滑不會繼續，因為我們看到了這種複蘇。

However, we do expect some of the COVID-related cost savings on productivity that we have seen during the quarter to stick also in the mid-term as we continue with our new ways of working internally and externally.

但是，我們確實預計，隨著我們繼續採用新的內部和外部工作方式，我們在本季度看到的一些與 COVID 相關的生產力成本節約也會在中期保持不變。

It is for these reasons that we remain confident on our margin goals and existing guidance both for the full year and mid-term.

正是由於這些原因，我們對全年和中期的利潤率目標和現有指導仍然充滿信心。

Again, I will get into some more detail on the guidance later.

同樣，稍後我將詳細介紹該指南。

Now Slide 17 shows here the key factors that impacted the first-half core operating profit performance and what we anticipate in the second half.

現在幻燈片 17 在這裡顯示了影響上半年核心營業利潤表現的關鍵因素以及我們對下半年的預期。

Clearly, the first-half core operating income growth was driven by the continued momentum of our growth drivers, especially Innovative Medicines and the key launches.

顯然，上半年核心營業收入增長是由我們增長動力的持續動力推動的，尤其是創新藥物和關鍵推出。

In addition, there was increased productivity driven by our transformation programs both at NTO and NBS, and of course, lower spending driven by COVID-19-related lockdowns.

此外，我們在 NTO 和 NBS 的轉型計劃推動了生產力的提高，當然，與 COVID-19 相關的封鎖也推動了支出的減少。

We saw some generic erosion, particularly to mature ophtha and oncology brands, and as discussed earlier, the negative impact on Lucentis and mature ophtha sales.

我們看到了一些仿製藥侵蝕，特別是對成熟的 ophtha 和腫瘤品牌，並且如前所述，對 Lucentis 和成熟的 ophtha 銷售的負面影響。

Now as we turn to the second half, we anticipate core operating income growth to be somewhat lower than the first half.

現在我們轉向下半年，我們預計核心營業收入增長將略低於上半年。

Of course, we expect the momentum of our growth drivers and launches as well as the productivity benefits to continue.

當然，我們預計我們的增長動力和發布以及生產力收益的勢頭將繼續下去。

But we also expect increased generic erosion, mainly on Afinitor and Exjade as well as increased investments to support upcoming launches, particularly ofatumumab and inclisiran.

但我們也預計仿製藥侵蝕會增加，主要是在 Afinitor 和 Exjade 上，以及增加投資以支持即將推出的產品，特別是 ofatumumab 和 inclisiran。

Further, we will also start lapping the acquisition of Xiidra as of Q3 of this year.

此外，我們還將從今年第三季度開始著手對 Xiidra 的收購。

Slide 18.

幻燈片 18。

It shows our guidance and key assumptions.

它顯示了我們的指導和關鍵假設。

We are confirming our guidance and tightening the given prior ranges to be at the higher end for core operating income and at the lower end of the range for sales.

我們正在確認我們的指導並收緊給定的先前範圍，以使核心營業收入處於較高端，而銷售範圍則處於較低端。

So we now expect continued operation sales to grow mid-single-digit.

因此，我們現在預計持續運營銷售額將增長中個位數。

Core operating income is expected to grow ahead of sales at low double-digit.

預計核心營業收入將以兩位數的低位增長領先於銷售額。

And within this, the divisions, we expect Innovative Medicines to grow mid-single-digit and Sandoz to grow low single-digit.

在此範圍內，我們預計創新藥物將增長中個位數，而 Sandoz 將增長低個位數。

Our guidance assumes that we see a continuation of the return to normal global healthcare systems, including prescribing dynamics, particularly in ophthalmology, in the second half of the year.

我們的指導假設我們看到在今年下半年繼續恢復正常的全球醫療保健系統，包括處方動態，特別是眼科。

In addition, we assume that no Gilenya and no Sandostatin LAR generics enter in 2020 in the U.S.

此外，我們假設 2020 年沒有 Gilenya 和 Sandostatin LAR 仿製藥進入美國。

On the free cash flow on Slide 19, of course cash flow remains very important, particularly in light of the current situation, but of course always important for us.

關於幻燈片 19 上的自由現金流，當然現金流仍然非常重要，尤其是考慮到目前的情況，但當然對我們來說總是很重要。

And on Slide 19, you see our free cash flow growing 3% in the first half.

在幻燈片 19 上，您會看到我們上半年的自由現金流增長了 3%。

It's mainly driven by our operating income growth, of course adjusted for noncash items and somewhat a bit underrepresent the operational growth because of lower divestment proceeds.

這主要是由我們的營業收入增長推動的，當然也針對非現金項目進行了調整，並且由於撤資收益較低，因此在某種程度上代表了運營增長。

You may recall, last year, we had quite a large divestment of parts of our Basel campuses and overall very strong operation and cash collection.

您可能還記得，去年，我們對巴塞爾校區的部分資產進行了相當大的撤資，總體而言，運營和現金回收非常強勁。

That's very important because also the day sales outstanding are in line with year-end 2019, so we don't see any issue on cash collections.

這非常重要，因為當日銷售額與 2019 年底一致，因此我們認為現金收款沒有任何問題。

And maybe one additional point, as we look into quarter 3, we do expect to pay most of the legal settlement fees in quarter 3.

也許還有一點，當我們進入第 3 季度時，我們確實希望在第 3 季度支付大部分法律和解費用。

Finally, on Slide 20, as currencies are constantly changing, I want to bring it to your attention what we see as the estimate currency impact on our results using the current exchange rates.

最後，在幻燈片 20 上，由於貨幣在不斷變化，我想提請您注意我們認為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 2020, the full-year impact of currencies on sales would be a negative 1 to 2 percent points and our core operating income negative 4 percent points.

因此，如果 7 月中旬的利率在 2020 年剩餘時間內占主導地位，貨幣對銷售額的全年影響將是負 1 到 2 個百分點，我們的核心營業收入將是負 4 個百分點。

For quarter 3, it would be 0 to negative 1 point on sales and negative 3 points on core operating income.

第三季度，銷售額為 0 至負 1 點，核心營業收入為負 3 點。

As you know, we do update this every month.

如您所知，我們每個月都會更新此內容。

I encourage you to look at it because it is also with the U.S. dollar, the euro quite volatile.

我鼓勵你看看它，因為它也與美元、歐元相當波動。

With that, I hand over to Marie-France.

有了這個，我移交給 Marie-France。

Thank you, Harry.

謝謝你，哈利。

Good morning, good afternoon.

早上好，下午好。

If we take a look at Slide 22, pharma had a solid growth of 8% for the first half of 2020 despite the significant market disruptions in Q2.

如果我們看一下幻燈片 22，儘管第二季度市場出現重大中斷，但 2020 年上半年製藥業仍實現了 8% 的穩健增長。

The products that had a strong TR base and that are self-administered saw very solid performance.

擁有強大TR基礎和自我管理的產品表現非常穩定。

And in particular, our main growth drivers, Entresto and Cosentyx, outperformed the markets.

特別是，我們的主要增長動力 Entresto 和 Cosentyx 表現優於市場。

We stayed focused on our strategy, and we've quickly pivoted to virtual execution.

我們一直專注於我們的戰略，並迅速轉向虛擬執行。

We've learned a lot how to accelerate the patient journey, how to make our engagement more seamless and how to deliver our promotion in a more customized way.

我們學到了很多如何加快患者旅程，如何使我們的參與更加無縫以及如何以更加個性化的方式提供我們的促銷活動。

We will continue to think boldly about how we use digital to enhance the way we activate patients, tailor education and execute launches.

我們將繼續大膽思考如何使用數字技術來增強我們激活患者、定制教育和執行發布的方式。

If we take a look at Cosentyx on Slide 23, Cosentyx has been resilient despite a significant COVID impact on dermatology and rheumatology new starts.

如果我們看一下幻燈片 23 上的 Cosentyx，儘管 COVID 對皮膚病學和風濕病學的新起點產生了重大影響，但 Cosentyx 一直保持彈性。

Cosentyx outperformed in the U.S. across indications.

Cosentyx 在美國的各種跡像都表現出色。

As I said, Cosentyx has a strong TRx base.

正如我所說，Cosentyx 擁有強大的 TRx 基礎。

In fact, 75% of our business is TRx-based, supported by 5 years of safety and efficacy data and broad first-line access.

事實上，我們 75% 的業務是基於 TRx 的，有 5 年的安全性和有效性數據以及廣泛的一線訪問支持。

Our focus during this time has been on maintaining patients on therapy and supporting the physician community.

在此期間，我們的重點是維持患者接受治療並支持醫生社區。

Now we're seeing recovery in the market.

現在我們看到市場正在復蘇。

We've been back in the field since June 1. And we expect to continue to outperform the market.

自 6 月 1 日以來，我們已重返該領域。我們預計將繼續跑贏市場。

If I go to the next slide, I wanted to spend a little bit of time talking about Cosentyx.

如果我轉到下一張幻燈片，我想花一點時間談談 Cosentyx。

There's been a lot of news flow within this space recently.

最近這個領域有很多新聞流。

This market space is very competitive and is becoming more and more competitive.

這個市場空間競爭非常激烈，而且競爭越來越激烈。

And although we should never underestimate the competition, there are very good reasons why Cosentyx will continue to grow and go beyond $5 billion in sales.

儘管我們永遠不應低估競爭，但 Cosentyx 將繼續增長並超過 50 億美元的銷售額有很好的理由。

If we take a look at the dermatology market, it's a big market.

如果我們看看皮膚科市場，這是一個很大的市場。

And despite all of the good treatments, biologic penetration is still low.

儘管有所有好的治療方法，生物滲透率仍然很低。

Remember that Cosentyx offers a complete treatment approach.

請記住，Cosentyx 提供完整的治療方法。

We have robust evidence in skin and unique data in scalp, nail and palmoplantar.

我們有強有力的皮膚證據和頭皮、指甲和掌蹠的獨特數據。

Together with broad first-line access, we have everything we need in this space to continue to grow.

加上廣泛的一線准入，我們擁有在這個領域繼續發展所需的一切。

If we look at rheumatology, it's a less competitive market space as the IL-23s are not proven across the axial SpA spectrum.

如果我們看看風濕病學，它的市場競爭力較弱，因為 IL-23 並未在軸向 SpA 範圍內得到證實。

And obviously then, IL-17s are the class of choice for this indication.

顯然，IL-17 是該適應症的首選。

We have a strong momentum to continue to grow.

我們有繼續增長的強勁動力。

And in fact, we're growing faster in rheumatology than we are in dermatology.

事實上，我們在風濕病學領域的發展速度比在皮膚病學領域的發展速度要快。

We've also just received our nonradiographic axial SpA approval, completing our label and allowing us to move earlier in the disease spectrum.

我們還剛剛獲得了我們的非放射軸向 SpA 批准，完成了我們的標籤並允許我們在疾病譜中更早地移動。

If we look at the way forward, we want to trailblaze with Cosentyx.

如果我們展望未來，我們希望與 Cosentyx 一起開拓創新。

We want to bring this drug to a potential 3.5 million additional patients with an LCM strategy that brings us from 5 to 10 indications.

我們希望通過 LCM 策略將這種藥物帶給潛在的 350 萬額外患者，該策略為我們帶來 5 到 10 個適應症。

If we move on to Entresto -- Entresto is Entresto; it continues to do well.

如果我們繼續討論 Entresto——Entresto 就是 Entresto；它繼續表現良好。

Demand was resilient as physicians were keen to keep patients out of hospital.

由於醫生熱衷於讓患者遠離醫院，因此需求具有彈性。

Cardiologists now see Entresto as standard of care and Q2 has only reinforced this.

心髒病專家現在將 Entresto 視為護理標準，而 Q2 只是加強了這一點。

While our NBRx were affected, the TRx base remained solid.

雖然我們的 NBRx 受到影響，但 TRx 基礎仍然穩固。

In Q1, we talked about NBRx at 4,500.

在第一季度，我們談到了 4,500 的 NBRx。

We saw a drop to almost half of that.

我們看到下降到幾乎一半。

And now we're back to 3,800.

現在我們又回到了 3,800。

So we have complete confidence that we'll see Entresto back to its Q1 trend line.

因此，我們完全有信心看到 Entresto 回到其第一季度的趨勢線。

In addition, we've passed some milestones towards opening up new patient populations.

此外，我們在開闢新的患者群體方面取得了一些里程碑式的成就。

The FDA has accepted our file for HFpEF.

FDA 已接受我們的 HFpEF 文件。

We've seen approval in Japan.

我們已經在日本看到了批准。

And we continue to progress our PARADISE-MI for heart failure prevention.

我們繼續推進我們的 PARADISE-MI 預防心力衰竭。

Moving on to Slide 26, with Beovu, our focus continues to be on safety and transparency.

轉到第 26 張幻燈片，與 Beovu 一起，我們的重點仍然是安全性和透明度。

And we're staying fully committed to Beovu.

我們將全力支持 Beovu。

We concluded the SRC review.

我們結束了 SRC 審查。

We've also continued to publish all of the post-marketing data on our website in full transparency.

我們還繼續以完全透明的方式在我們的網站上發布所有的上市後數據。

We've had the health authority decisions on the label updates and approvals, which confirm the benefit/risk profile remains positive.

我們已經就標籤更新和批准做出了衛生當局的決定，這證實了利益/風險狀況仍然是積極的。

We're also working with 25 external experts to help us work on root causes, risk factors, mitigation and treatment options.

我們還與 25 位外部專家合作，幫助我們研究根本原因、風險因素、緩解和治療方案。

The reason why we're staying committed to Beovu is that patients need treatment that provide better fluid resolution.

我們一直致力於 Beovu 的原因是患者需要能夠提供更好的液體分辨率的治療。

25% of patients receive monthly injections.

25% 的患者每月接受一次注射。

And many of them abandon the treatment due to the burden of treatment.

並且很多人因為治療負擔而放棄治療。

They need a different solution.

他們需要不同的解決方案。

From the get-go, we had great feedback from retina specialists on the efficacy of Beovu.

從一開始，我們就收到了視網膜專家對 Beovu 功效的良好反饋。

Now we've just presented a post hoc data that was presented at ARVO that firmly establishes the link between fluid and visual outcomes, something we always believed in and now we can prove.

現在我們剛剛展示了在 ARVO 上展示的事後數據，它牢固地建立了流體和視覺結果之間的聯繫，這是我們一直相信的，現在我們可以證明這一點。

We know from HAWK and HARRIER that Beovu is better in reducing retinal fluid.

我們從 HAWK 和 HARRIER 得知 Beovu 在減少視網膜液方面效果更好。

We're playing the long game here and we're staying committed to this product.

我們在這裡打持久戰，我們將繼續致力於這個產品。

If I move to Slide 27, we're very much looking forward to bringing ofatumumab to market.

如果我轉到幻燈片 27，我們非常期待將 ofatumumab 推向市場。

And we believe the FDA now has all the data they need to give us the green light.

我們相信 FDA 現在擁有為我們開綠燈所需的所有數據。

What is most compelling about ofatumumab is that it can give patients the possibility to live relapse-free for 9 to 10 years.

ofatumumab 最引人注目的是它可以讓患者有可能在 9 到 10 年內無復發地生活。

What ofatumumab does is it effectively depletes B cells.

ofatumumab 的作用是有效地消耗 B 細胞。

This is the most efficacious way to treat MS. We've also developed this product specifically for MS with a favorable safety.

這是治療 MS 最有效的方法。我們還專門為 MS 開發了這款產品，具有良好的安全性。

It's also dosed precisely to sustain B cell depletion and it comes in a subcu injection.

它的劑量也可以精確地維持 B 細胞的消耗，並且它採用 subcu 注射。

This has the potential to truly change how physicians treat MS in first line and first switch.

這有可能真正改變醫生在一線和首次轉換中治療 MS 的方式。

Our focus in these past months has been to make it as easy as possible to prescribe and access this product.

在過去的幾個月裡，我們的重點是讓開處方和使用該產品盡可能容易。

We've invested significantly in patient services and are rethinking our onboarding to make it seamless and flexible.

我們在患者服務方面進行了大量投資，並正在重新考慮我們的入職培訓，以使其無縫和靈活。

Our launch will be tailored in a very different environment but with a very different approach, state-by-state, prescriber-by-prescriber.

我們的發布將在一個非常不同的環境中進行定制，但採用非常不同的方法，逐個州，逐個開處方。

And as soon as we get the green light from FDA, we'll be ready to launch.

一旦我們得到 FDA 的批准，我們就準備好啟動了。

If I move to Slide 28, last but not least, we're progressing on our launch preparations for inclisiran.

如果我轉到幻燈片 28，最後但並非最不重要的一點是，我們正在為 inclisiran 的發布做準備。

ASCVD is a major burden for patients and for health care systems.

ASCVD 是患者和醫療保健系統的主要負擔。

In fact, in the U.S., more than 15 million patients have uncontrolled LDL-C despite treatment.

事實上，在美國，儘管接受了治療，仍有超過 1500 萬患者的 LDL-C 未得到控制。

It's also a major burden for healthcare systems.

這也是醫療保健系統的主要負擔。

The U.S. spends $350 billion on CV diseases every year.

美國每年在心血管疾病上花費 3500 億美元。

And although there are effective options available, the problem persists.

儘管有可用的有效選項，但問題仍然存在。

We think we can tackle ASCVD much more effectively by leveraging the unique aspects of inclisiran with a new commercial model that addresses the nonclinical barriers.

我們認為，通過利用 inclisiran 的獨特方面以及解決非臨床障礙的新商業模式，我們可以更有效地解決 ASCVD。

That means addressing affordability for systems and patients, enabling access that ensures rapid patient onboarding at point of care and impacting adherence with an HCP-administered product.

這意味著解決系統和患者的負擔能力，實現訪問以確保患者在護理點快速入職，並影響對 HCP 管理產品的依從性。

If we can do that, we have a real chance at tackling ASCVD at a completely different scale.

如果我們能做到這一點，我們就有真正的機會以完全不同的規模解決 ASCVD。

So in conclusion, our growth drivers, Cosentyx and Entresto, have delivered solid performance.

因此，總而言之，我們的增長動力 Cosentyx 和 Entresto 取得了穩健的業績。

We remain focused on our strategy to maximize our growth drivers, deliver on our launches and prepare for our next big bets.

我們仍然專注於我們的戰略，以最大限度地提高我們的增長動力、交付我們的產品並為我們的下一個大賭注做準備。

The organization has showed high agility in our current context.

該組織在我們當前的環境中表現出高度的敏捷性。

We've accelerated our journey to digital, tested new engagement models and focused on customer solutions.

我們加快了數字化之旅，測試了新的參與模式，並專注於客戶解決方案。

This will only make us stronger in the future.

這只會讓我們在未來變得更強大。

Over to Susanne.

交給蘇珊。

Thank you, Marie-France.

謝謝你，瑪麗-法蘭西。

Moving to Slide 30.

轉到幻燈片 30。

So you see the Oncology business remains resilient in the face of COVID-19, delivering 6% of growth in the first half of this year with sales of $7.2 billion.

因此，您會看到，面對 COVID-19，腫瘤業務保持彈性，今年上半年實現了 6% 的增長，銷售額達到 72 億美元。

We have seen very good momentum across our portfolio, mainly driven by strong uptake of our recent launches, namely Kisqali, Kymriah, Piqray, Adakveo and most recently launched Tabrecta.

我們在投資組合中看到了非常好的勢頭，主要是由於我們最近推出的 Kisqali、Kymriah、Piqray、Adakveo 和最近推出的 Tabrecta 的強勁吸收。

But also our growth drivers, Promacta/Revolade, Tafinlar + Mekinist and Jakavi continued strong double-digit growth.

但我們的增長動力，Promacta/Revolade、Tafinlar + Mekinist 和 Jakavi 也繼續保持兩位數的強勁增長。

These brands could more than compensate for the continued generic erosion that we saw on Afinitor and Exjade, Jadenu in the U.S. and Sandostatin LAR in EU.

這些品牌可以彌補我們在 Afinitor 和 Exjade、美國的 Jadenu 和歐盟的 Sandostatin LAR 上看到的持續仿製藥侵蝕。

Lutathera achieved $105 million.

Lutathera 實現了 1.05 億美元。

And here, we saw softer performance driven by an increased number of cancellations and delays in new patient starts due to COVID-19.

在這裡，我們看到由於 COVID-19 導致新患者開始的取消和延遲數量增加，導致業績疲軟。

Overall, the Oncology business is very resilient.

總體而言，腫瘤業務非常有彈性。

And we see continued strong performance of in-market brands and recent launches.

我們看到市場品牌和最近推出的持續強勁表現。

Moving to Slide 31, we are very pleased with Kisqali sales reaching $159 million and continued growth through the pandemic.

轉到幻燈片 31，我們對 Kisqali 的銷售額達到 1.59 億美元並在大流行期間持續增長感到非常高興。

This growth is based on very strong demand as Kisqali is the only CDK4/6 inhibitor with 2 positive overall survival readouts.

這種增長是基於非常強勁的需求，因為 Kisqali 是唯一具有 2 個陽性總生存期讀數的 CDK4/6 抑製劑。

And just to remind you that Kisqali has a differentiated profile versus other CDK4/6 inhibitors with preferential inhibition to CDK4 versus CDK6 and a high concentration to inhibit the target.

並且提醒您，Kisqali 與其他 CDK4/6 抑製劑相比具有差異化特徵，優先抑制 CDK4 與 CDK6 和高濃度以抑制靶標。

In Q2, we have seen very strong uptick in market share gains ex U.S., especially in European markets, where now both post- and premenopausal indications were approved for reimbursement in big markets like Germany, Italy, France and Spain.

在第二季度，我們看到除美國以外的市場份額增長非常強勁，特別是在歐洲市場，現在德國、意大利、法國和西班牙等大市場批准了絕經後和絕經前適應症的報銷。

But also in the U.S., Kisqali continued to grow and gain market share in Q2 despite the slowdown of the CDK4/6 class, driven by delays in new patients start.

但在美國，儘管 CDK4/6 級別放緩，但由於新患者開始延遲，Kisqali 在第二季度繼續增長並獲得市場份額。

And NBRx for the class was down 10% in Q2.

第二季度該課程的 NBRx 下降了 10%。

To further support physicians and patients, we have implemented a home monitoring program to ensure that patients can stay at home and have the required monitoring they need for Kisqali treatment.

為了進一步支持醫生和患者，我們實施了一項家庭監測計劃，以確保患者可以留在家中並獲得 Kisqali 治療所需的監測。

We are also rapidly enrolling in our NATALEE trial in high and intermediate AT1 breast cancer and are on track to complete enrollment in 2020.

我們還在快速註冊我們的 NATALEE 中高 AT1 乳腺癌試驗，並有望在 2020 年完成註冊。

NATALEE has a different design than the other ongoing trials in AT1 setting with a 3-year treatment regimen.

NATALEE 的設計與 AT1 環境中其他正在進行的試驗不同，其治療方案為 3 年。

So overall, we are very pleased with the performance of Kisqali.

所以總的來說，我們對 Kisqali 的表現非常滿意。

And moving to Kymriah on Slide 32, Kymriah continued its very strong trajectory with Q2 sales of $118 million.

在幻燈片 32 上搬到 Kymriah 後，Kymriah 繼續保持強勁勢頭，第二季度銷售額為 1.18 億美元。

And this was driven by strong continued growth in the U.S. and in Europe.

這是由美國和歐洲強勁的持續增長推動的。

Our team has done an outstanding job by ensuring no interruption of supply during COVID-19 and no single dose of treatment was missed during the pandemic.

我們的團隊做得非常出色，確保在 COVID-19 期間不會中斷供應，並且在大流行期間沒有錯過任何一劑治療。

We continue to expand our global presence.

我們將繼續擴大我們的全球影響力。

We have now over 240 centers qualified to administer Kymriah across 25 countries, where Kymriah is covered for at least one indication.

我們現在在 25 個國家/地區擁有超過 240 個有資格管理 Kymriah 的中心，其中 Kymriah 至少有一個適應症。

But we also have made significant progress in expanding our global manufacturing capacity in the first half of 2020 with a 75% increase compared to previous year.

但我們在 2020 年上半年擴大全球製造能力方面也取得了重大進展，與去年相比增長了 75%。

EMA has now approved commercial manufacturing of Kymriah at our Novartis-owned facilities in Stein, Switzerland and in Les Ulis in France.

EMA 現已批准在我們位於瑞士 Stein 和法國 Les Ulis 的 Novartis 擁有的工廠進行 Kymriah 的商業生產。

We are also pleased that FDA has granted a regenerative medicine advanced therapy designation to Kymriah for relapsed/refractory follicular lymphoma.

我們也很高興 FDA 授予 Kymriah 用於復發/難治性濾泡性淋巴瘤的再生醫學高級治療指定。

And we have completed enrollment to our ELARA trial and are on track for submission in 2021.

我們已經完成了 ELARA 試驗的註冊，並有望在 2021 年提交。

Moving to Tabrecta on Slide 33.

在幻燈片 33 上移至 Tabrecta。

This is the first and only MET inhibitor approved by the FDA to specifically target metastatic non-small cell lung cancer patients with a MET exon-14 mutation.

這是 FDA 批准的第一個也是唯一一個專門針對具有 MET 外顯子 14 突變的轉移性非小細胞肺癌患者的 MET 抑製劑。

This is indicated for 3% to 4% of non-small cell lung cancer patients that have this mutation.

這適用於 3% 至 4% 的具有這種突變的非小細胞肺癌患者。

And there is a substantial unmet need existing among these patients as usually they have, unfortunately, a very poor prognosis and modest benefit from existing therapies.

這些患者中存在大量未滿足的需求，不幸的是，他們通常預後非常差，並且從現有療法中獲益不大。

We have launched Tabrecta simultaneously with an FDA-approved MET exon-14 CDx test.

我們與 FDA 批准的 MET exon-14 CDx 測試同時推出了 Tabrecta。

And due to the pandemic event, this is the first-ever web-based, full digital launch.

由於大流行事件，這是有史以來第一次基於網絡的全數字發布。

We already see good market response and positive customer feedback with more than 20,000 visitors on our patient website and 9,000 visitors on the HCP website in the first months of the launch.

我們已經看到了良好的市場反應和積極的客戶反饋，在推出的頭幾個月，我們的患者網站上有超過 20,000 名訪問者和 HCP 網站上的 9,000 名訪問者。

And last week, we had our first Tabrecta Livestream Week.

上週，我們舉辦了第一個 Tabrecta 直播週。

And we had outstanding, more than 1.8 million views.

我們有超過 180 萬的觀看次數。

So the market is responding well.

所以市場反應良好。

More than 30 leading cancer institutions have started patients on Tabrecta.

超過 30 家領先的癌症機構已經開始使用 Tabrecta 治療患者。

We have also received approval in Japan in June.

我們也在 6 月份獲得了日本的批准。

And we are now preparing for the launch.

我們現在正在為發布做準備。

We initiated also a strong development plan to maximize the potential of Tabrecta with the opportunity to serve an additional 40,000 patients.

我們還啟動了一項強有力的發展計劃，以最大限度地發揮 Tabrecta 的潛力，並有機會為額外的 40,000 名患者提供服務。

We have started or planning several monotherapy trials, a confirmatory Phase III trial as well as further trials of just Tabrecta in specific populations such as brain metastasis and in a tumor-agnostic setting.

我們已經開始或計劃進行幾項單一療法試驗、一項確認性 III 期試驗以及僅 Tabrecta 在特定人群（例如腦轉移和腫瘤不可知環境中）的進一步試驗。

But what is even more exciting is our plan to explore Tabrecta into combinations that will allow us to potentially expand beyond the MET exon-14 subset.

但更令人興奮的是我們計劃將 Tabrecta 探索成組合，這將使我們有可能擴展到 MET 外顯子 14 子集之外。

So overall, an encouraging start for Tabrecta.

所以總的來說，對於 Tabrecta 來說，這是一個令人鼓舞的開始。

We are now gearing up for a launch in Japan.

我們現在正準備在日本推出。

And I believe we have very exciting plans to maximize the potential of Tabrecta.

而且我相信我們有非常激動人心的計劃來最大限度地發揮 Tabrecta 的潛力。

And with that, over to Vas.

有了這個，到Vas。

Thank you, Susanne.

謝謝你，蘇珊。

So moving to Slide 35, here's an updated list of the key catalysts.

轉到幻燈片 35，這裡是關鍵催化劑的更新列表。

I've already covered, I think, or we've covered most of them over the course of the presentation.

我想我已經介紹過了，或者我們在演示過程中已經介紹了其中的大部分內容。

But just for all of you to have them in one place.

但只是為了讓你們所有人將它們放在一個地方。

And so turning to Slide 36.

所以轉向幻燈片 36。

In conclusion, strong first half performance, demonstrating the agility and resilience, I think, of the company, confirming our full-year 2020 guidance with some tightening on the specific sales and core operating parameters.

總之，強勁的上半年業績，展示了公司的敏捷性和彈性，我認為，確認了我們對 2020 年全年的指導，並在特定的銷售和核心運營參數上有所收緊。

Our growth drivers are on track as you heard throughout the presentation.

正如您在整個演示文稿中所聽到的那樣，我們的增長動力正在步入正軌。

And the pipeline is delivering with the full range of mid- to late-stage assets as we've outlined.

正如我們所概述的，該管道正在交付全方位的中後期資產。

With that, we'll open the line for questions.

有了這個，我們將打開問題線。

So operator?

那麼運營商？

(Operator Instructions) First question comes from the line of Peter Welford from Jefferies.

（操作員說明）第一個問題來自 Jefferies 的 Peter Welford。

I'll just start with 2, please.

請從 2 開始。

One, just on Zolgensma, in terms of the intrathecal formulation, thanks for the update on that.

一，就鞘內製劑而言，就在 Zolgensma 上，感謝您對此的更新。

I guess I understand the decision to make for the 1-year nonhuman primate data.

我想我理解為 1 年非人類靈長類動物數據做出的決定。

Curious if you can also update us with regards to the dose.

好奇您是否也可以更新我們的劑量。

Are you still considering filing the mid-dose?

你還在考慮申請中劑量嗎？

And is there any requirement to get any follow-up of patients on the high dose at all for FDA?

FDA 是否有任何要求對高劑量患者進行任何隨訪？

What's your latest thinking with regards to the clinical package that you'd be submitting to the agency?

關於您將提交給該機構的臨床包裹，您的最新想法是什麼？

And then secondly, if we just move on to Cosentyx, I wonder if you could just update us on 2 things there: firstly, the dynamics you're seeing in Europe with regards to the recovery in the derm and rheum segments; and secondly, also on the dynamics you're seeing in China there with regards to, I think, the launch is obviously in psoriasis and also now AS.

其次，如果我們繼續討論 Cosentyx，我想知道您是否可以向我們介紹兩件事：首先，您在歐洲看到的關於真皮和大黃部門復甦的動態；其次，關於你在中國看到的動態，我認為，發布顯然是針對銀屑病和現在的 AS。

Just with regards to what you're seeing in the patient dynamics in China, please.

請談談您在中國的患者動態中看到的情況。

Thank you, Peter.

謝謝你，彼得。

So first, on Zolgensma IT, we are currently in the process of submitting the clinical data for review to FDA, planning a series of discussions with them over the course of the fall, leading up to a pre-BLA meeting.

因此，首先，在 Zolgensma IT 上，我們目前正在向 FDA 提交臨床數據以供審查，計劃在秋季與他們進行一系列討論，直至召開 BLA 前會議。

Our position is that our mid-dose is sufficient to support a licensure from a clinical package standpoint.

我們的立場是，從臨床包裝的角度來看，我們的中等劑量足以支持許可。

And that's what we will be presenting to the agency.

這就是我們將向該機構展示的內容。

In terms of Cosentyx, EU and China dynamics, Marie-France?

在 Cosentyx、歐盟和中國的動態方面，Marie-France？

Yes.

是的。

So as I said, we outperformed the market in the U.S. We still don't have the Q2 data for Europe.

正如我所說，我們的表現優於美國市場。我們仍然沒有歐洲的第二季度數據。

But what I can say is that the situation was very different depending on the countries.

但我可以說的是，情況因國家而異。

So those countries that were in strict lockdowns, we obviously saw a real impact in the new starts or switches, but we're slowly returning back to normality.

因此，那些處於嚴格封鎖狀態的國家，我們顯然在新的開始或轉換中看到了真正的影響，但我們正在慢慢恢復正常。

So for Europe, I would say our estimate is that we're probably -- we'll see a flat growth.

所以對於歐洲，我會說我們的估計是我們可能 - 我們會看到一個平穩的增長。

Over Q1, we saw significant growth in both dermatology and rheumatology.

在第一季度，我們看到皮膚病學和風濕病學的顯著增長。

But there was probably some stocking in there that was reversed.

但那裡可能有一些被顛倒的庫存。

In China, the pattern is very similar.

在中國，模式非常相似。

So we did see in Q1 versus Q2, so Q2 was back to normal.

所以我們確實看到了第一季度與第二季度的對比，所以第二季度恢復了正常。

But in China, we did see quite a significant drop in Cosentyx.

但在中國，我們確實看到了 Cosentyx 的大幅下降。

We're now completely back on track.

我們現在完全回到了正軌。

The next question comes from the line of Andrew Baum from Citi.

下一個問題來自花旗的 Andrew Baum。

A couple of questions.

幾個問題。

First, to Vas, I'd be interested in your thoughts to the extent that the goodwill the industry is generating as a result of its work on COVID therapeutics and vaccines protects them from the uncertainties over U.S. reimbursement reform.

首先，對於 Vas，我對您的想法很感興趣，因為該行業在 COVID 療法和疫苗方面的工作所產生的善意可以保護他們免受美國報銷改革的不確定性的影響。

We've obviously all seen the unity platform proposals from Biden.

顯然，我們都看到了拜登提出的統一綱領提案。

I just wonder how lax we should not be and how protective you think the goodwill being generated ultimately is.

我只是想知道我們不應該有多鬆懈，以及你認為最終產生的善意有多保護。

Second, if John is on the call, I think historically, he's answered the question to me about the preserved ejection fraction filing for Entresto as saying you're seeking a broad label, not subgroups.

其次，如果約翰在電話中，我認為從歷史上看，他已經回答了我關於 Entresto 保留射血分數申請的問題，說您正在尋找一個廣泛的標籤，而不是子組。

I'm assuming that the PARALLAX data supports that, particularly the 6-minute walk point -- and the 6-minute walk endpoint.

我假設視差數據支持這一點，尤其是 6 分鐘步行點和 6 分鐘步行終點。

We haven't seen that data.

我們還沒有看到這些數據。

Perhaps you might like to share what that trial showed to inform our confidence about potential FDA decision.

也許您可能想分享該試驗的結果，以告知我們對潛在 FDA 決定的信心。

And then finally, on HORIZON, the TQJ230 Phase III trial, could you talk to whether there are interims in the trial that may result in a readout prior to 2024, whether there's no interims because you're looking for a cardiovascular mortality?

最後，關於 HORIZON，TQJ230 III 期試驗，您能否談談試驗中是否存在可能導致 2024 年之前讀數的過渡期，是否因為您正在尋找心血管死亡率而沒有過渡期？

Yes.

是的。

Thanks, Andrew.

謝謝，安德魯。

On the first question, I think it's been very positive to see the recognition of the important role the industry plays in global health response, pandemic response and overall, the appreciation of R&D, both in vaccines and therapeutics.

關於第一個問題，我認為看到該行業在全球衛生應對、大流行應對以及總體上對疫苗和療法研發的重視所發揮的重要作用得到認可，這是非常積極的。

That said, I don't believe that the goodwill will carry over to a significant degree into the legislative dynamics.

也就是說，我不相信善意會在很大程度上延續到立法動態中。

I think more of what I would expect to see is a range of different proposals as we've seen in the past.

我認為我希望看到的更多是我們過去看到的一系列不同的提案。

And what will ultimately come forward out of that, it still remains to be seen as to whether it will be the continued incremental changes we've seen historically or something more fundamental.

最終會出現什麼，這仍然是我們在歷史上看到的持續增量變化還是更根本的變化，還有待觀察。

I think, overall, we are supportive.

我認為，總的來說，我們是支持的。

And I think many of our peers are supportive of a benefit redesign that really enables patients to pay less out of pocket in order to get their medicines.

而且我認為我們的許多同行都支持福利重新設計，這確實使患者能夠以更少的自付費用來獲得他們的藥物。

But I think in the current dynamic in the U.S., there's a lot of uncertainties and we'll see how it plays out.

但我認為，在美國目前的動態中，存在很多不確定性，我們將拭目以待。

But I don't believe the goodwill insulates us from those policy dynamics.

但我不相信善意使我們免受這些政策動態的影響。

John, on HFpEF?

約翰，關於 HFpEF？

Yes.

是的。

On HFpEF, thanks, Andrew, for the question.

關於 HFpEF，謝謝 Andrew 的提問。

Thanks for the question, Andrew, on HFpEF.

感謝 Andrew 提出關於 HFpEF 的問題。

As we said previously, we're looking for a broad label and our position hasn't changed.

正如我們之前所說，我們正在尋找一個廣泛的標籤，我們的立場沒有改變。

As Marie-France noted earlier, the FDA has accepted our filing in June and that's the approach.

正如 Marie-France 早些時候指出的那樣，FDA 已在 6 月份接受了我們的申請，這就是我們的方法。

You alluded to the PARALLAX data, which we did actually get the results late last year.

你提到了視差數據，我們確實在去年年底得到了結果。

And this is a 24-week study looking at the primary endpoint, which is NT-pro-BNP.

這是一項為期 24 週的研究，著眼於主要終點，即 NT-pro-BNP。

We did reach the NT-pro-BNP endpoint.

我們確實達到了 NT-pro-BNP 終點。

You referred to the 6-minute walk test.

你提到了6分鐘步行測試。

We did not see a significant difference in the 6-minute walk test.

我們在 6 分鐘步行測試中沒有看到顯著差異。

As you probably know, this endpoint is particularly challenging when we look at cardiovascular endpoints.

您可能知道，當我們查看心血管終點時，這個終點特別具有挑戰性。

But however, with the NT-pro-BNP, we do believe that this is supportive of our overall filing for the broad population.

但是，對於 NT-pro-BNP，我們確實相信這支持我們對廣大人群的整體申請。

So with this overall endpoint, we will move forward with the filing and look forward to feedback from the FDA.

因此，有了這個總體終點，我們將繼續提交申請，並期待 FDA 的反饋。

And then John, on HORIZON is there any interim analysis, LP(a)?

然後約翰，在 HORIZON 上是否有任何中期分析，LP(a)？

Yes.

是的。

Currently, we're recruiting for LP(a) with TQJ.

目前，我們正在招募 TQJ 的 LP(a)。

There is interim analysis built in.

有內置的臨時分析。

I don't have the exact time points of when the interim is built in.

我沒有內置臨時程序的確切時間點。

But we're currently in the early stages of recruitment for the TQJ study.

但我們目前正處於 TQJ 研究招募的早期階段。

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

下一個問題來自 Cowen 的 Steve Scala。

A few questions.

幾個問題。

It looks like a number of key timelines have been pushed out: Zolgensma in type 2, 3; Entresto, post-acute MI data; Kisqali OS data; and the 177Lu-PSMA Phase III data in the filing.

看起來一些關鍵的時間線已經被推出：Zolgensma 在類型 2、3； Entresto，急性心肌梗死後數據； Kisqali 操作系統數據；以及備案中的 177Lu-PSMA III 期數據。

I know each has an explanation, but no timeline was brought forward.

我知道每個人都有解釋，但沒有提出時間表。

Are these push-outs due to COVID-19?

這些推出是由於 COVID-19 造成的嗎？

Or is there some other systemic reason for all of these pushouts?

或者所有這些推出還有其他一些系統性原因嗎？

Secondly, on Zolgensma, is there a specific scientific reason to seek longer-term primate data for the IT formulation?

其次，在 Zolgensma 上，是否有特定的科學理由為 IT 制定尋求更長期的靈長類動物數據？

For instance, is there evidence that dorsal root ganglia toxicity can appear late post dosing?

例如，是否有證據表明背根神經節毒性會在給藥後後期出現？

And then lastly, the Novartis COVID-19 vaccine collaboration was not mentioned in the release.

最後，發布中未提及諾華 COVID-19 疫苗合作。

Is this still in development?

這還在開發中嗎？

Yes.

是的。

Thanks, Steve.

謝謝，史蒂夫。

On the first question, I'll take that.

關於第一個問題，我會接受。

First, I think it's important to know, as you rightfully point out, there's different dynamics in each and not to tell a simple story when there's obviously complex things going on.

首先，我認為重要的是要知道，正如你正確指出的那樣，每個人都有不同的動力，當發生明顯複雜的事情時，不要講述一個簡單的故事。

Both Kisqali OS and Lu-PSMA are event-driven studies that are driven by our ability to accumulate events.

Kisqali OS 和 Lu-PSMA 都是由我們積累事件的能力驅動的事件驅動研究。

In both studies, we're seeing events accumulate more slowly.

在這兩項研究中，我們都看到事件累積得更慢。

We're hopeful that could be because of the effect of the drug.

我們希望這可能是因為藥物的作用。

We can't confirm that.

我們無法確認。

But because these are event-driven studies, we're ultimately at the mercy of when these events happen.

但是因為這些是事件驅動的研究，我們最終會受到這些事件何時發生的擺佈。

And as soon as they read out, they read out.

他們一念出來，就念出來。

With respect to -- with respect to the PARADISE study, I don't believe it's a pushout.

關於 - 關於 PARADISE 研究，我不認為這是一個推脫。

Is it, John?

是嗎，約翰？

Well, what we had is we were accruing events.

好吧，我們所擁有的是我們正在累積事件。

And this is another event-driven trial.

這是另一個事件驅動的試驗。

So I think we're looking for the events to accrue.

所以我認為我們正在尋找累積的事件。

And the timelines will be sometime next year when we get the readout.

時間表將在明年某個時候我們得到讀數。

And then lastly, I think Zolgensma was a company decision based on a development strategy, which then leads me to the second question.

最後，我認為 Zolgensma 是基於發展戰略的公司決策，這使我想到了第二個問題。

When you look at nonhuman primate data, the only thing you see -- of course, with a onetime therapy you see certain findings on pathological examination at the time of the initial dosing.

當您查看非人類靈長類動物的數據時，您唯一看到的就是——當然，對於一次性治療，您會在初始給藥時看到病理學檢查的某些發現。

Over time, you can evaluate the primates for any clinical manifestations as well as how those pathologies evolve.

隨著時間的推移，您可以評估靈長類動物的任何臨床表現以及這些病理如何演變。

The longer you follow, the more likelihood you have for further resolution and more data you have that this had no clinical impact on the primates.

您關注的時間越長，您就越有可能獲得進一步的解決方案，並且您擁有的數據越多，這對靈長類動物沒有臨床影響。

FDA initially requested 1 year.

FDA 最初要求 1 年。

We went back with a proposal for 6 months.

我們帶著一份為期 6 個月的提案回去了。

FDA accepted the proposal but encouraged us to consider the ramifications of 6 months versus 1 year.

FDA 接受了該提議，但鼓勵我們考慮 6 個月與 1 年的影響。

And I think, in the end, we made the decision to go with 1 year because we think that gives us the highest probability of success on this very critical medicine for these patients.

而且我認為，最終，我們做出了 1 年的決定，因為我們認為這使我們在這種對這些患者非常關鍵的藥物上獲得成功的可能性最高。

So that's the analysis for how we approach that.

這就是我們如何處理的分析。

And we'll follow the monkey -- but we don't expect, to your specific question, any late insult.

我們將跟隨猴子——但對於您的具體問題，我們不期望任何遲到的侮辱。

This is actually monitoring the resolution of the initial findings over the course of the first year.

這實際上是在監測第一年的初步調查結果的解決情況。

And then the referral to the vaccine program, overall, our goal was to support a novel vaccine development using AAV technology.

然後轉介到疫苗計劃，總的來說，我們的目標是支持使用 AAV 技術的新型疫苗開發。

We are going to produce the preclinical lots, but we are not a vaccine manufacturer.

我們將生產臨床前批次，但我們不是疫苗製造商。

Our goal in COVID is focused on therapeutics.

我們在 COVID 中的目標集中在治療上。

We have 2 pivotal studies.

我們有 2 項關鍵研究。

We have over 20 IITs -- over 30 IITs, I should say, of our existing medicines.

我們有 20 多個 IIT——我應該說，我們現有的藥物中有 30 多個 IIT。

We have a novel drug-discovery program targeting 2 different targets to try to find a pan-coronavirus medicine.

我們有一個針對 2 個不同目標的新型藥物發現計劃，試圖找到一種泛冠狀病毒藥物。

And we hope to get those hopefully into the clinic next year if things go according to plan.

如果一切按計劃進行，我們希望明年能讓這些人進入診所。

So our focus is very much on medicines, not on vaccines.

所以我們的重點是藥物，而不是疫苗。

But we're very willing to use our manufacturing capacity to support the development of any candidate vaccines for COVID.

但我們非常願意利用我們的製造能力來支持任何 COVID 候選疫苗的開發。

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

下一個問題來自美國銀行的 Graham Parry。

So firstly, on the CANOPY study, I think you previously said the interim analysis in Q4 is 2021.

所以首先，關於 CANOPY 研究，我想你之前說過第四季度的中期分析是 2021 年。

But I think I heard you say there is now both PFS and OS in fourth quarter, not just a PFS analysis.

但我想我聽到你說第四季度現在既有 PFS 又有 OS，而不僅僅是 PFS 分析。

So is that a change in the statistical analysis plan?

那麼這是統計分析計劃的變化嗎？

And has the hurdle, therefore, changed as well?

因此，障礙是否也發生了變化？

Secondly, on Zolgensma intrathecal, just to be clear, is the nonhuman primate data needed both for a BLA filing and also to get off clinical hold at the high dose?

其次，關於 Zolgensma 鞘內註射，需要明確的是，非人類靈長類動物數據是否既需要用於 BLA 文件，也需要在高劑量下停止臨床試驗？

Or is it possible for you just to file low- and mid-dose and never actually get off high-dose clinical hold?

或者您是否有可能只申請低劑量和中劑量而從未真正擺脫高劑量臨床暫停？

And then thirdly, on ofatumumab, could you help us with the exact PDUFA date and clarify if by then you think the site inspections would have happened?

第三，關於ofatumumab，您能否幫助我們確定確切的PDUFA日期並澄清您是否認為屆時會進行現場檢查？

Because I know they were delayed or canceled because of COVID-19.

因為我知道他們因為 COVID-19 而被推遲或取消。

And just thoughts on the environment you'll be launching into in the second half of the year and how you might have to tailor that launch.

只是想想你將在今年下半年推出的環境，以及你可能必須如何調整這次發布。

Thanks, Graham.

謝謝，格雷厄姆。

On CANOPY, John, the PFS, OS interim?

關於 CANOPY、John、PFS、OS 過渡？

Yes.

是的。

Thanks for the question, Graham.

謝謝你的問題，格雷厄姆。

And first, I'd like to say that we haven't had any changes in terms of our statistical analysis plan for CANOPY.

首先，我想說的是，我們對 CANOPY 的統計分析計劃沒有任何變化。

Just a reminder for the folks online, CANOPY is our first-line trial in non-small cell lung cancer with canakinumab.

只是提醒在線人們，CANOPY 是我們使用卡那單抗治療非小細胞肺癌的一線試驗。

And really, this study is designed using co-primary endpoints.

實際上，這項研究是使用共同主要終點設計的。

It's a novel approach that we've taken, looking at both PFS and OS in the first interim analysis, which will occur in the fourth quarter of this year.

這是我們採用的一種新穎方法，在今年第四季度進行的第一次中期分析中同時考察了 PFS 和 OS。

And this would be our first opportunity to really take a look in terms of the results that we'll get.

這將是我們第一次有機會真正了解我們將獲得的結果。

The -- this -- I should outline that there will be a high hurdle for us to look at the PFS and OS for the stopping rules of the study.

- 這個 - 我應該概述一下，我們將面臨一個很高的障礙來查看 PFS 和 OS 以了解研究的停止規則。

So if the PFS endpoint is met, I think we will make a decision whether we will stop the study or continue with the study in terms of continuation with the OS overall results.

因此，如果達到 PFS 終點，我認為我們將決定是停止研究還是繼續研究，以繼續獲得 OS 整體結果。

So with that as the background, I think this is how we will approach CANOPY-1.

因此，以此為背景，我認為這就是我們處理 CANOPY-1 的方式。

And just to be clear, we can win on either PFS or OS at both interim analyses this year and next year, when the final readout at the end of next year.

需要明確的是，在今年和明年的中期分析中，我們可以在 PFS 或 OS 上獲勝，屆時將在明年年底進行最終讀數。

In terms of Zolgensma IT, we do need to get off clinical hold to be able to file the BLA -- our partial clinical hold.

就 Zolgensma IT 而言，我們確實需要停止臨床暫停才能提交 BLA——我們的部分臨床暫停。

So our -- that is why our goal is to get off partial clinical hold by generating this 1-year nonhuman primate study.

所以我們的 - 這就是為什麼我們的目標是通過開展這項為期 1 年的非人類靈長類動物研究來擺脫部分臨床停滯。

But from a clinical standpoint, we are proposing with the FDA to go forward with the mid-dose STRONG data, which we believe has compellingly demonstrated the impact Zolgensma has in these 2- to 5-year-old children.

但從臨床角度來看，我們提議與 FDA 一起推進中劑量 STRONG 數據，我們認為這些數據有力地證明了 Zolgensma 對這些 2 至 5 歲兒童的影響。

And then lastly, I think the third question was on the ofa PDUFA timelines, John?

最後，我認為第三個問題是關於 PDUFA 時間表的，John？

Yes.

是的。

So the timing for ofa was based on, as you remember, the 3-month extension from the FDA.

因此，正如你所記得的，ofa 的時間安排是基於 FDA 的 3 個月延期。

And the timelines currently are in the mid-September time frame.

目前的時間表是在 9 月中旬的時間範圍內。

I don't have the exact date, but it's mid-September.

我沒有確切的日期，但它是九月中旬。

And so we're negotiating the aspects of label with FDA.

因此，我們正在與 FDA 就標籤方面進行談判。

And we expect to reach those timelines, as Vas presented earlier.

正如 Vas 之前介紹的那樣，我們希望達到這些時間表。

And then Graham, there's no outstanding inspections or otherwise outstanding topics, so really in the final stages.

然後是格雷厄姆，沒有突出的檢查或其他突出的主題，所以真的是在最後階段。

And I think, Marie-France, on the launch?

我想，Marie-France，在發布會上？

Yes.

是的。

So we really feel that there's no better time to bring a highly efficacious and safe treatment that can be administered at home to MS patients, considering the context.

因此，考慮到具體情況，我們真的覺得現在是為 MS 患者在家中進行高效安全治療的最佳時機。

Our initial focus will be to really drive the broad adoption with MS specialists and general neurologists.

我們最初的重點將是真正推動 MS 專家和普通神經科醫生的廣泛採用。

And we're using a really highly agile approach between face-to-face and virtual outreach.

我們在面對面和虛擬外展之間使用了一種非常靈活的方法。

We've actually developed a digital affinity score for physicians to understand where they are and how much digital promotion we can do.

實際上，我們已經為醫生開發了一個數字親和力評分，以了解他們在哪里以及我們可以做多少數字推廣。

We're also leveraging our learnings from recent launches and facing significant focus on patient services to ensure seamless and flexible onboarding.

我們還利用我們從最近推出的產品中獲得的經驗，並重點關注患者服務，以確保無縫和靈活的入職。

So that's really -- our objective is to make sure that patients can access quickly and easily ofatumumab.

所以那是真的 - 我們的目標是確保患者可以快速輕鬆地獲得ofatumumab。

We expect to see ramp-up in 2021 as we see the conversion of patients to product in ex U.S. towards the second half of 2021.

我們預計 2021 年將出現增長，因為我們看到在 2021 年下半年之前美國以外的患者將轉變為產品。

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

下一個問題來自摩根士丹利的 Mark Purcell。

And thanks for the detail in the slides today as well.

並感謝今天幻燈片中的詳細信息。

Firstly, on innovation.

首先，關於創新。

Can you help us understand on inclisiran the appetite for governments outside the U.K. to participate in risk-sharing deals with you?

您能否幫助我們了解英國以外的政府參與與您分擔風險的交易的意願？

I'm just trying to understand what your expectations are -- for the uptake are ahead of the outcome stage in 2024 and whether we should look at inclisiran, the rollout to that product, as being a barometer potential success for TQJ230.

我只是想了解你的期望是什麼——因為在 2024 年的結果階段之前，我們是否應該將推出該產品的 inclisiran 視為 TQJ230 潛在成功的晴雨表。

And then secondly, on the other side of the coin, clearly, growth drivers, 47% with the pharma sales.

其次，在硬幣的另一面，很明顯，增長驅動力，47% 來自藥品銷售。

But there are some drags, which are difficult for us to quantify.

但是有一些阻力，我們很難量化。

So maybe for you, Harry, VBP (inaudible) was announced today.

所以也許對你來說，Harry，今天宣布了 VBP（聽不清）。

So if tomorrow, (inaudible) Galvus and Diovan, we estimate it's roughly 20% of your China sales, just to get your view there.

因此，如果明天，（聽不清）Galvus 和 Diovan，我們估計它大約佔您在中國的銷售額的 20%，只是為了讓您了解那裡的情況。

And then secondly, on the other established and the other ophthalmology products, there's about $4.3 billion in sales in those buckets last year.

其次，在其他成熟產品和其他眼科產品上，去年這些產品的銷售額約為 43 億美元。

Could you help us with an outlook in terms of the run rate there, so we can follow things like Travatan sales in the U.S. But it's more difficult for us to understand the size of these products and the potential drags going forward.

您能否幫助我們了解那裡的運行率前景，以便我們可以跟踪諸如 Travatan 在美國的銷售情況。但我們更難了解這些產品的規模和未來的潛在阻力。

Those are my 2 questions.

這是我的兩個問題。

Thank you, Mark.

謝謝你，馬克。

So first on the inclisiran commercialization outlook, Marie-France?

那麼首先談談 inclisiran 的商業化前景，Marie-France？

Yes.

是的。

So I think everyone realizes that ASCVD is a major burden for systems.

所以我想每個人都意識到 ASCVD 是系統的主要負擔。

And we also know we've got about 1 million patient data points on LDL and the fact that it's a modifiable risk factor.

而且我們還知道我們有大約 100 萬個關於 LDL 的患者數據點以及它是一個可改變的風險因素這一事實。

So we know that.

所以我們知道。

And actually, what kind of stands in the way are the nonclinical barriers.

實際上，阻礙的是非臨床障礙。

So when we think about population health, what we're talking about is really trying to develop new partnerships with health care systems, systems of care that address these nonclinical barriers.

因此，當我們考慮人口健康時，我們真正談論的是試圖與醫療保健系統建立新的伙伴關係，即解決這些非臨床障礙的醫療保健系統。

We believe that if we do that and inclisiran has a unique profile, that allows us to address some of the main nonclinical barriers that are out there.

我們相信，如果我們這樣做，並且 inclisiran 具有獨特的特徵，這使我們能夠解決一些主要的非臨床障礙。

One is affordability, there's access and there's adherence.

一是負擔能力，有訪問權，有遵守。

So if we do that and we model that properly, then we really have an opportunity to impact this disease at scale but also the cost.

因此，如果我們這樣做並正確建模，那麼我們真的有機會大規模影響這種疾病，但也有成本。

So, so far, we're in discussion with different payers, with different systems, not only in the U.K. And it's, of course, early days.

所以，到目前為止，我們正在與不同的付款人、不同的系統進行討論，不僅在英國。當然，這還處於早期階段。

But the conversations we're having are encouraging.

但我們正在進行的對話令人鼓舞。

Because I think that systems realize that if they can address this burden, it would make a major difference for them.

因為我認為系統意識到，如果他們能夠解決這個負擔，這將對他們產生重大影響。

And read-through of TQJ, Marie-France?

並通讀 TQJ，Marie-France？

So yes, absolutely.

所以是的，絕對的。

So if we are able to establish these partnerships with health care systems and with governments, then it does open the door for us to start partnering with health care systems in a completely different way.

因此，如果我們能夠與醫療保健系統和政府建立這些夥伴關係，那麼它確實為我們打開了以完全不同的方式與醫療保健系統合作的大門。

So in the same way that we would be looking at LDL-C and trying to make a major difference for these patients, we could actually do the same with LP(a).

因此，就像我們研究 LDL-C 並試圖對這些患者產生重大影響一樣，我們實際上可以對 LP(a) 做同樣的事情。

Now moving to China, I'll take that question.

現在搬到中國，我會回答這個問題。

We're certainly aware that with the VBP, a number of our products will be in this next round, round 3. But I think it's important to know, when we set the aspiration to double our China business, our focus was on new launches.

我們當然知道，通過 VBP，我們的一些產品將進入下一輪第三輪。但我認為重要的是要知道，當我們設定將中國業務翻一番的願望時，我們的重點是新產品的發布.

And when you look at it, with over 50 NDA submissions into China -- or 25, sorry, NDA submissions into China between now and 2022, really a leading number of NRDL listings.

從現在到 2022 年，有超過 50 份 NDA 提交到中國——或者抱歉，25 份，抱歉，從現在到 2022 年，中國提交的 NDA 確實是 NRDL 列表中的領先數量。

We've already talked about how Cosentyx is performing, Entresto, our oncology portfolio.

我們已經討論了 Cosentyx 的表現如何，Entresto 是我們的腫瘤學產品組合。

We've guided our China organization to really focus on new launches in driving their uptake and except the fact that there will be some commoditization of our legacy brands.

我們已經指導我們的中國組織真正專注於新品發布，以推動它們的吸收，但我們的傳統品牌將會商品化。

So our guidance to double our China sales takes into account the fact that we will have the impact of the round 3 of China VBP.

因此，我們將中國銷售額翻番的指導考慮到了我們將受到中國 VBP 第三輪影響的事實。

And then lastly, Harry, on other ophthalmology?

最後，哈利，關於其他眼科？

Yes.

是的。

So I think your question also alluded to that some of the established medicines, how are they behaving.

所以我認為你的問題也暗示了一些成熟的藥物，它們的表現如何。

And you see that, in our established medicines bucket, we usually have mid-single-digit declines.

您會看到，在我們已建立的藥品桶中，我們通常會出現中個位數的下降。

Now Diovan and Exforge are holding up.

現在 Diovan 和 Exforge 堅持了下來。

They have seen the first half, each $0.5 billion and roughly flat to prior year.

他們已經看到了上半年，每個 5 億美元，與去年基本持平。

When it comes to ophtha, we have highlighted that a couple of ophtha products, mainly Travatan, Travoprost, have basically generic exposure.

當談到 ophtha 時，我們強調了一些 ophtha 產品，主要是 Travatan、Travoprost，基本上具有通用曝光率。

That group was last year roughly $400 million.

該集團去年約為 4 億美元。

And we are basically having a generic impact also on quarter 2 in the range of $40 million to $50 million.

而且我們基本上對第 2 季度也產生了 4000 萬美元到 5000 萬美元的一般影響。

So part of the mature ophtha impact, but it's not significant yet, is a generization (sic - genericization) of the Travatan/Travoprost group.

因此，成熟的 ophtha 影響的一部分，但還不顯著，是 Travatan/Travoprost 組的泛化（原文如此 - 泛化）。

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

下一個問題來自瑞銀的 Laura Sutcliffe。

I think you said on your first quarter earnings call that you still see Beovu as being a blockbuster product.

我認為您在第一季度財報電話會議上表示，您仍然認為 Beovu 是一款重磅產品。

Given that you have another quarter of experience, should we assume that, that's still the case?

鑑於您還有四分之一的經驗，我們是否應該假設，情況仍然如此？

And I think from some of your commentary today, should we assume that there will be a fairly long grind up towards blockbuster status, if it is still the case?

我認為，從你今天的一些評論來看，我們是否應該假設，如果仍然如此，我們是否應該假設會有相當長的時間才能達到重磅炸彈的地位？

And then secondly, on Zolgensma, it looks as though Biogen is going to do some work looking at using Spinraza in patients who have already been treated with Zolgensma.

其次，在 Zolgensma 上，看起來百健（Biogen）將做一些工作，研究在已經接受過 Zolgensma 治療的患者中使用 Spiraza 。

So I was just wondering if you had any updates on what you plan to do with branaplam.

所以我只是想知道你是否有任何關於你打算用 branaplam 做什麼的更新。

Yes.

是的。

Thanks, Laura.

謝謝，勞拉。

So first, on Beovu, Marie-France?

那麼首先，關於 Beovu，Marie-France？

So to answer your question, yes, we believe.

所以回答你的問題，是的，我們相信。

We absolutely believe and we're staying committed to this product.

我們絕對相信並且我們將繼續致力於該產品。

We have a safety issue.

我們有一個安全問題。

It's a rare safety issue.

這是一個罕見的安全問題。

We're taking that seriously.

我們正在認真對待這一點。

We've got to understand what the root cause is, what the mitigation factors are.

我們必須了解根本原因是什麼，緩解因素是什麼。

But we have an outstanding product, a product that is better on fluid resolution and where there is a clear unmet medical need for many patients who abandon therapy and end up losing their vision anyway.

但我們有一款出色的產品，一種在液體分辨率方面更好的產品，並且對於許多放棄治療並最終失去視力的患者來說，顯然存在未滿足的醫療需求。

So we're absolutely committed to finding the solutions for Beovu to regive confidence to physicians.

因此，我們絕對致力於為 Beovu 尋找解決方案，以重振醫生的信心。

We know that this product works extremely well in the vast majority of patients.

我們知道該產品對絕大多數患者都非常有效。

We continue to focus on the benefit/risk.

我們繼續關注收益/風險。

And we're not going to lose sight of the longer-term potential of Beovu.

我們不會忽視 Beovu 的長期潛力。

Yes.

是的。

And then on Zolgensma, we continue to evaluate a full life cycle management plan for Zolgensma to really enable us to profile the medicine's impact in a range of different patient populations.

然後在 Zolgensma 上，我們繼續評估 Zolgensma 的完整生命週期管理計劃，以真正使我們能夠描述藥物對一系列不同患者群體的影響。

I would note that, as to date, we have not seen any decline in Zolgensma patients who received this therapy.

我要指出，到目前為止，我們還沒有看到接受這種治療的 Zolgensma 患者有任何下降。

In fact, in our clinical trial data as well as in the real world, we see patients maintaining the milestones they gained with Zolgensma.

事實上，在我們的臨床試驗數據以及現實世界中，我們看到患者保持著他們使用 Zolgensma 獲得的里程碑。

So I think that's important in thinking through any combination-based approaches.

所以我認為這對於思考任何基於組合的方法都很重要。

That said, we do have -- are evaluating a potential approach with branaplam.

也就是說，我們確實 - 正在評估一種使用 branaplam 的潛在方法。

And we're also evaluating the use of branaplam in other neuromuscular diseases as well.

我們也在評估 branaplam 在其他神經肌肉疾病中的應用。

And so we'll keep the markets updated as we finalize those plans.

因此，當我們最終確定這些計劃時，我們會及時更新市場。

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

下一個問題來自高盛的 Keyur Parekh。

I have three, please, one for Vas, one for Harry and one for Marie-France on Zolgensma.

請給我三份，一份給 Vas，一份給 Harry，一份給 Marie-France，在 Zolgensma。

Vas, you -- the last 12 months, kind of Novartis has made significant progress on a bunch of things, including kind of as you alluded to, the historical legacy issues on delivering on kind of cost initiatives and some of the launches.

Vas，你——在過去的 12 個月裡，諾華公司在很多事情上都取得了重大進展，包括你提到的那種在實施成本計劃和一些發射方面的歷史遺留問題。

But they have also been kind of benchmarked by some -- what people are considering some execution wrinkles.

但它們也被一些人作為基準——人們正在考慮一些執行問題。

What do you -- do you think the rest of the organization is able to keep up with the pace of change that you want the organization to change at?

你怎麼看——你認為組織的其他人能夠跟上你希望組織改變的速度嗎？

Or do you think that's not a factor in some of the issues we've seen over the last 12 months?

還是您認為這不是我們在過去 12 個月中看到的一些問題的一個因素？

That's question number one.

這是第一個問題。

Question number two for you, Harry.

給你的第二個問題，哈利。

Given the 19% operating -- core operating profit growth you've delivered in the first half of the year, your guidance for the full year essentially implies kind of 0 to very little operating profit growth in the second half of the year.

鑑於您在上半年實現了 19% 的運營——核心運營利潤增長，您對全年的指導基本上意味著下半年的運營利潤增長為 0 到非常少。

I'm cognizant that you guys typically guide very conservatively but would love to hear how much of the second half conservatism on the guidance includes an increase in spend from some of the kind of normal marketing activities becoming real?

我知道你們通常非常保守地指導，但很想听聽指導的下半年保守主義有多少包括從一些正常的營銷活動變為現實的支出增加？

Or do you think if the current situation were to continue, that would be upside to your targets for the year?

或者你認為如果目前的情況繼續下去，那會比你今年的目標有利嗎？

And then lastly, on Zolgensma, the U.S. number at $105 million this quarter, I suspect it was a bit below what most people are expecting.

最後，在 Zolgensma 上，本季度美國的銷售額為 1.05 億美元，我懷疑這比大多數人的預期要低一些。

And core reason that a lot of it was due to the lack of switches from use from Spinraza users.

其中很多的核心原因是由於 Spiraza 用戶缺乏使用開關。

So my question is whether that lack of switch is attributable to COVID-19.

所以我的問題是，缺乏開關是否歸因於 COVID-19。

Or do you see some of those lack of switches also being attributable to physicians kind of housing their patients in front of a potential multi-plan launch?

或者您是否看到其中一些缺乏開關也歸因於醫生在潛在的多計劃推出之前將他們的患者安置在其中？

Yes.

是的。

Thanks, Keyur.

謝謝，凱爾。

So first, on the first question, I get this -- I got this, I think, during a few different investor conversations.

所以首先，關於第一個問題，我明白了——我想，我是在幾次不同的投資者對話中得到的。

What I'd note is, on the one hand, we have had a few issues, which we would have preferred to avoid, some beyond our control, like the Beovu safety issue as well as the ofatumumab delay because of CMC delays at the FDA.

我要指出的是，一方面，我們遇到了一些我們希望避免的問題，其中一些超出了我們的控制範圍，例如 Beovu 安全問題以及由於 FDA 的 CMC 延遲導致的 ofatumumab 延遲.

But again, those were not necessarily fully in our control.

但同樣，這些不一定完全在我們的控制之下。

And I think it's also notable that with respect to the Zolgensma data topic, again there was no action taken.

我認為同樣值得注意的是，關於 Zolgensma 數據主題，同樣沒有採取任何行動。

At the same time, it's worth investors remembering that we also delivered the largest spin in European capital markets history with Alcon, 6 new NMEs that were approved last year, which was also an industry record, have transformed the overall strategy of the company and have upgraded our ESG rating.

同時，值得投資者記住的是，我們還與愛爾康一起實現了歐洲資本市場歷史上最大規模的旋轉，去年獲批的 6 家新 NME，這也是行業記錄，改變了公司的整體戰略，並上調了我們的 ESG 評級。

So I would actually say the organization is executing very well.

所以我實際上會說該組織執行得非常好。

But we, I think, also accept the margin for error is small.

但我認為，我們也承認誤差幅度很小。

And so we will keep working to avoid those errors.

因此，我們將繼續努力避免這些錯誤。

I would say our perception is there's been an overreaction, when you look at the overall dynamics of the business, 6% sales growth, 19% core operating income growth and a pipeline that's consistently ranked 1 of the top 3 in the industry in almost every measure that we can find as well as a broad range of assets that you see on the slides.

我想說，我們的看法是反應過度了，當您查看業務的整體動態、6% 的銷售增長、19% 的核心營業收入增長以及在幾乎所有行業中始終排名前三的管道時我們可以找到的衡量標準以及您在幻燈片上看到的各種資產。

So that is our feeling.

這就是我們的感覺。

We feel like the organization is in a strong position.

我們覺得該組織處於強勢地位。

The culture change is on track.

文化變革步入正軌。

Our pivot to innovation is on track.

我們的創新重心正在走上正軌。

Our margin expansion is well on track to get to the mid- to high 30s as we guided well ahead of the commitments we made.

我們的利潤率擴張有望達到 30 多歲的中高水平，因為我們的指導遠遠超過了我們做出的承諾。

I think we're one of the leaders in the data and digital transformation.

我認為我們是數據和數字化轉型的領導者之一。

And when you look with building trust with society, it's not just us talking, now you're seeing the rating agencies also move as well.

當你著眼於與社會建立信任時，不僅僅是我們在談論，現在你看到評級機構也在行動。

So I would stay tuned, and we're grateful for the long-term investors who stay the course and see the strong potential of the company.

所以我會繼續關注，我們感謝那些堅持到底並看到公司強大潛力的長期投資者。

And we hope to commence the remainder.

我們希望開始剩下的工作。

Now with respect to guidance, Harry?

現在關於指導，哈利？

Yes.

是的。

Thank you, Keyur.

謝謝你，凱爾。

Clearly, with the first half, having delivered 19% and guiding on the full year to low double-digit kind of takes low to mid-single-digit in the second half.

顯然，上半年已經交付了 19% 並在全年實現低兩位數，下半年需要低到中個位數。

That looks achievable.

這看起來可以實現。

So you can assume that our guidance is prudent.

所以你可以假設我們的指導是謹慎的。

But it's also volatile times.

但這也是動蕩的時期。

So we will update on quarter 3, would be great to see some upside, but it's a bit too early to upgrade.

所以我們將在第三季度更新，很高興看到一些上漲，但現在升級還為時過早。

And then lastly, on the Zolgensma topic, I'll take that as our AveXis unit is run by Dave Lennon, who reports to me.

最後，關於 Zolgensma 話題，我認為我們的 AveXis 部門由向我匯報的 Dave Lennon 負責。

The dynamics in the U.S. are really one driven by COVID.

美國的動態實際上是由 COVID 驅動的。

And we do expect our run rates in the U.S. to come back up to really a situation where we get the vast majority of patients identified in newborn screening and back to a healthy level of switch.

我們確實希望我們在美國的運行率能夠恢復到這樣一種情況，即我們在新生兒篩查中發現了絕大多數患者，並恢復到健康的轉換水平。

Understandably, in the context of COVID in April, May and June, parents were reluctant, of course, to bring their young children, who are immunocompromised, into the hospital for potential switch evaluation.

可以理解的是，在 4 月、5 月和 6 月發生 COVID 的情況下，父母當然不願意將免疫功能低下的幼兒帶到醫院進行潛在的轉換評估。

We're already seeing a rebound.

我們已經看到了反彈。

I think what's really notable and important is to understand the SMA market, unlike many other markets, is larger ex U.S. than in the U.S. And as you saw in the dynamic, even in Q2, we had very robust performance in the ex U.S. markets, Japan and Europe as well as with the named patient programs in markets where we don't have approval yet.

我認為真正值得注意和重要的是了解 SMA 市場，與許多其他市場不同，除美國外的市場規模比美國大而且正如您在動態中看到的那樣，即使在第二季度，我們在美國前市場的表現也非常強勁，日本和歐洲以及我們尚未獲得批准的市場中的指定患者計劃。

And we expect to have a broad range of approvals going forward.

我們預計未來將獲得廣泛的批准。

So the real catalyst now is going to be those ex U.S. markets moving forward.

因此，現在真正的催化劑將是那些前美國市場向前發展。

The next question comes from the line of -- from Simon Baker from Redburn.

下一個問題來自 Redburn 的 Simon Baker。

Two, please.

兩個，請。

Firstly, for Harry, in Q1, you helpfully gave us the margin ex the effects of COVID.

首先，對於 Harry，在第一季度，您在 COVID 的影響之外為我們提供了利潤。

I just wanted to ask if, given you haven't done that this quarter, that there were no COVID-related impacts, be they positive or negative in the margin.

我只是想問一下，鑑於您在本季度沒有這樣做，是否沒有與 COVID 相關的影響，無論是正面還是負面。

And if there are, could you tell us what they are and in what direction?

如果有，你能告訴我們它們是什麼以及朝什麼方向嗎？

And related to that, you talked about the greater use of digital within product launches.

與此相關，您談到了在產品發布中更多地使用數字化。

Over time, what sort of impact do you think that could have on SG&A?

隨著時間的推移，您認為這會對 SG&A 產生什麼樣的影響？

And secondly, a Sandoz question for Richard.

其次，為 Richard 提出的 Sandoz 問題。

Given that the FDA's public meeting on PDUFA reauthorization started 15 minutes ago, I thought it would be a good time to ask you what your hopes and expectations for PDUFA III are.

鑑於 FDA 關於 PDUFA 重新授權的公開會議於 15 分鐘前開始，我認為現在是詢問您對 PDUFA III 的希望和期望是什麼的好時機。

So Harry, on the margins?

所以哈利，在邊緣？

Thank you, Simon.

謝謝你，西蒙。

Of course, we were thinking a lot about this, what kind of details do we put in.

當然，我們在這方面考慮了很多，我們放入了什麼樣的細節。

Now as we progress in this kind of COVID year, things get a bit blurred, if you will, right, to exactly -- I mean it's never exact science here.

現在，隨著我們在這種 COVID 年取得進展，事情變得有點模糊，如果你願意的話，對，確切地說——我的意思是這裡從來都不是精確的科學。

So I think what's most important is to look at half 1, where we see we had this forward buying or stocking of the patient level in quarter 1. Then we have signs that mostly this has been depleted.

所以我認為最重要的是看半 1，我們看到我們在第一季度對患者水平進行了這種前瞻性購買或庫存。然後我們有跡象表明這大部分已經耗盡。

And then what are COVID effects?

那麼新冠病毒的影響是什麼？

We have positive COVID effects.

我們有積極的 COVID 影響。

Because in our chronic, let's say, at-home administered medicines, we see more persistence and better dynamics.

因為在我們的慢性藥物中，比如說，在家服用藥物，我們看到了更多的持久性和更好的動力。

In some of the hospital-initiated, we have less.

在一些醫院發起的，我們少。

Then we have the ophthalmology business, where people cannot get their injection because the physicians -- so it gets quite mixed in all of this together.

然後我們有眼科業務，人們無法進行注射，因為醫生 - 所以它在所有這一切中混合在一起。

Therefore, we look at half 1.

因此，我們看一半 1。

And of course, you can make your own calculation, right?

當然，你可以自己計算，對吧？

You take the $400 million of stocking in Q1 and say, "Okay, I assume that now destocked." If you do that, that gives you, of course, a higher percentage on Q2.

你拿第一季度 4 億美元的庫存說，“好吧，我假設現在已經去庫存了。”如果你這樣做，那當然會給你第二季度更高的百分比。

But all of this gets a bit, I think, meaningless in the end.

但我認為，這一切最終都會變得毫無意義。

So what we have seen is unwinding of that $400 million stocking of Q1 and Q2.

因此，我們看到的是第一季度和第二季度 4 億美元的庫存減少。

We have seen $300 million roughly of lower ophthalmology sales, which otherwise was stable in all of the mature ophtha business.

我們已經看到大約 3 億美元的眼科銷售額較低，否則在所有成熟的眼科業務中都是穩定的。

And our growth brands have grown.

我們的成長品牌也在成長。

But then you can speculate how much would have grown without COVID.

但是，您可以推測如果沒有 COVID 會增長多少。

So therefore, I think you have the elements.

因此，我認為你有這些元素。

Important is the underlying business and the strong first half, where most of the stocking effects are out.

重要的是基礎業務和強勁的上半年，大部分庫存效應已經消失。

In terms of SG&A, I mean, the discretionary spend that -- and again, you can look at spend versus prior year.

就 SG&A 而言，我的意思是，可自由支配的支出——同樣，您可以查看與上一年相比的支出。

And of course, one can assume that with the growth of sales and the launches we had assumed in an ex COVID world, some growth of those investments, of course, below the sales line but still there, so several hundred millions of discretionary spend savings.

當然，人們可以假設，隨著銷售額的增長和我們在前 COVID 世界中假設的發布，這些投資的一些增長當然低於銷售線但仍然存在，因此可以節省數億美元的可自由支配支出.

And we do capture the key work stream we have, I'm sure, through other sets.

我敢肯定，我們確實通過其他系列捕捉了我們擁有的關鍵工作流程。

But certainly, we have a key work stream here to figure out how these new ways of working internally and externally drive more productive and efficient behaviors.

但可以肯定的是，我們在這裡有一個關鍵的工作流程來弄清楚這些新的內部和外部工作方式如何推動更有生產力和效率的行為。

But the first and ultimate goal is always to best serve our patients and customers and, of course, to ensure that our own associates are safe, satisfied and work very productive.

但首要也是最終目標始終是為我們的患者和客戶提供最好的服務，當然，還要確保我們自己的員工安全、滿意並且工作高效。

But we do believe that a good portion of those savings can stick also in the years going forward and that actually digital and virtual technologies will enable us maybe to serve our patients and customers even better.

但我們確實相信，這些節省的很大一部分也可以在未來幾年內持續下去，而且實際上數字和虛擬技術將使我們能夠更好地為我們的患者和客戶服務。

Thanks, Harry.

謝謝，哈利。

On digital launches, Marie-France, on use of digital technologies?

關於數字發布，Marie-France，關於數字技術的使用？

So our focus has been on 3 areas.

所以我們的重點是三個領域。

The first area has been on HCP engagement.

第一個領域是 HCP 參與。

And clearly, the objective here is to make sure that we can become more productive and so that we can get prescriptions faster and we've got a number of initiatives in place to make that happen.

顯然，這裡的目標是確保我們能夠變得更有效率，以便我們能夠更快地獲得處方，我們已經採取了一些舉措來實現這一目標。

The second initiative on the digital side is on the patient journey.

數字方面的第二項舉措是在患者旅程中。

So what can we do to activate patients faster, to look at areas like diagnosis, transition of care, adherence?

那麼我們能做些什麼來更快地激活患者，關注診斷、護理過渡、依從性等領域呢？

And there are a lot of digital tools that we're putting in place to just streamline that.

我們正在使用許多數字工具來簡化它。

The third area is around patient services.

第三個領域是圍繞患者服務。

So looking at patient services and how can we onboard and make sure that patients get access more easily.

因此，查看患者服務以及我們如何才能入職並確保患者更容易獲得訪問權。

Good.

好的。

Thanks, Marie-France.

謝謝，瑪麗-法蘭西。

And lastly, on the PDUFA negotiations, PDUFA discussions, I'd say, broadly industry is looking at a couple of key areas.

最後，關於 PDUFA 談判，PDUFA 討論，我想說，廣泛的行業正在關注幾個關鍵領域。

One is just always the continued focus on operational excellence at the agency both in terms of the ability to hire the necessary personnel as well as meeting excellence.

一是始終關注機構的卓越運營，無論是在僱傭必要人員的能力方面，還是在滿足卓越方面的能力方面。

Second is the -- ensuring the agency has enough capabilities to take on cell and gene and other advanced therapy platforms and really focus on that and then continued emphasis on data and digital technologies and ensuring the agency is in a position to support data and digital technologies in the future.

其次是——確保該機構有足夠的能力採用細胞和基因以及其他先進的治療平台，並真正專注於這一點，然後繼續強調數據和數字技術，並確保該機構能夠支持數據和數字技術將來。

Of course, these are our hopes.

當然，這些都是我們的希望。

Of course, the agency will have their hopes.

當然，該機構會有他們的希望。

And we'll hopefully get progress in the negotiations over the coming months.

我們希望在未來幾個月的談判中取得進展。

(Operator Instructions)

（操作員說明）

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

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

A question on Kisqali and NATALEE.

關於 Kisqali 和 NATALEE 的問題。

In Q1, you said that the interim analysis would happen in first half 2021.

在第一季度，您說中期分析將在 2021 年上半年進行。

So 1 quarter later now, you're saying it slips by a year to 1 half 2022, which is not very far from the trial completion date that you laid out, which is second half 2022.

因此，現在 1 個季度後，您說它會滑一年，到 2022 年的 1 年半，這與您制定的試驗完成日期（即 2022 年下半年）相距不遠。

And I'm just wondering why that big shift.

我只是想知道為什麼會有這麼大的轉變。

Is that a change in the statistical analysis plan that led to the timing shift, perhaps based on how you're interpreting and thinking about your trial versus PALACE?

這是導致時間轉移的統計分析計劃的變化嗎，也許是基於你如何解釋和思考你的試驗與 PALACE 的關係？

Or is that just merely a reflection of less events coming in?

或者這僅僅是減少事件的反映？

It just seems that moving that interim analysis closer to the completion of the trial may have reflected the former, some sort of guess on how yours may play out relative to PALACE.

似乎將中期分析更接近審判的完成可能反映了前者，對你的相對於 PALACE 可能如何發揮的某種猜測。

Yes.

是的。

Thanks, Tim.

謝謝，蒂姆。

John?

約翰？

Yes.

是的。

Thanks for the question, Tim.

謝謝你的問題，蒂姆。

We've not made any changes to the statistical analysis planned for the NATALEE trial.

我們沒有對 NATALEE 試驗計劃的統計分析進行任何更改。

What I can say is that the recruitment is going really well.

我能說的是，招聘進展非常順利。

We're -- currently, we have 4,000 patients for the study.

我們 - 目前，我們有 4,000 名患者參與這項研究。

We're recruiting over 250 patients per month on the study.

我們每月招募超過 250 名患者參與這項研究。

So things are coming along very well.

所以事情進展得很好。

On the interim, currently, we have interims planned at 50% and 70%.

在過渡期，目前，我們計劃的過渡期為 50% 和 70%。

So there are no changes there.

所以那裡沒有變化。

One thing that you did note is the MonarchE study, which was reported out with abemaciclib.

您確實注意到的一件事是 MonarchE 研究，該研究由 abemaciclib 報告出來。

And those results have not been fully disclosed with the exception of the press release.

除新聞稿外，這些結果尚未完全披露。

So based on information that we get, we are thinking about how we would evaluate moving forward NATALEE.

因此，根據我們獲得的信息，我們正在考慮如何評估未來的 NATALEE。

But like we said earlier, and Susanne highlighted, we're looking at both Stage 2 and Stage 3 patients for the adjuvant population of advanced breast cancer.

但就像我們之前所說的，Susanne 強調，我們正在研究晚期乳腺癌輔助人群的 2 期和 3 期患者。

So this would give us a comprehensive evaluation of these patients.

因此，這將使我們對這些患者進行全面評估。

So John, just to clarify, so we do still have the interims at 50% and 75%.

所以約翰，澄清一下，所以我們仍然有 50% 和 75% 的中間值。

So if we saw overwhelming efficacy, the trials would obviously stop earlier?

所以如果我們看到壓倒性的療效，試驗顯然會更早停止？

Exactly.

確切地。

That's the current approach.

這就是目前的做法。

The next question comes from the line of Seamus Fernandez, Guggenheim Partners.

下一個問題來自古根海姆合夥人 Seamus Fernandez 的觀點。

Just 2 quick questions.

只需 2 個快速問題。

First, I guess, this is more for Harry.

首先，我想，這更適合哈利。

Harry, can you just help us in terms of the second quarter Sandoz prior period adjustments and then also from that perspective, how you're going to drive growth in the second half as we kind of face some tougher comps in the second half of the year?

哈利，你能不能幫助我們在第二季度 Sandoz 前期調整方面，然後從這個角度來看，你將如何推動下半年的增長，因為我們在下半年面臨一些更艱難的競爭年？

And then just a quick question, can you just update us on the factor B data that we are likely to see towards the end of this year?

然後是一個簡單的問題，您能否向我們更新我們可能在今年年底看到的因素 B 數據？

What's the next dataset that we're going to see on factor B?

我們將在因子 B 上看到的下一個數據集是什麼？

Thanks, Seamus.

謝謝，西莫。

Harry, on Sandoz?

哈利，在山德士？

Yes.

是的。

I think you referred to revenue deduction basically, where one of the products, there was simply a better -- one of biosimilars in the U.S., a better contract outcome.

我認為您基本上指的是收入扣除，其中一種產品只是一種更好的產品——美國的一種生物仿製藥，一種更好的合同結果。

And therefore, the revenue deductions were positively impacted by an amount between $20 million and $30 million, so not so significant.

因此，收入扣除額受到了 2000 萬美元到 3000 萬美元之間的積極影響，因此並不那麼重要。

Maybe on the growth for the second half and more, it's more for Richard.

也許在下半年甚至更多的增長上，這對理查德來說更重要。

Richard?

理查德?

Thank you, John.

謝謝你，約翰。

So yes, second half, we -- in our guidance is low single digits.

所以是的，下半年，我們 - 在我們的指導下是低個位數。

We're seeing strong growth in biosimilars, and we're assuming that most of the COVID impact has been washed out by the end of H1.

我們看到生物仿製藥的強勁增長，我們假設大部分 COVID 影響已在 H1 結束時消失。

Thanks, Richard.

謝謝，理查德。

And factor B, John, the readouts?

和因素 B，約翰，讀數？

Yes.

是的。

Thanks, Seamus.

謝謝，西莫。

And on LNP023, which is our factor B inhibitor, Vas highlighted earlier that we're looking at this in multiple indications, including hematologic as well as various renal indications.

對於我們的因子 B 抑製劑 LNP023，Vas 早些時候強調說，我們正在研究多種適應症，包括血液學和各種腎臟適應症。

The next set of data, as you were asking about, is really in the PNH space.

正如您所詢問的那樣，下一組數據實際上是在 PNH 空間中。

This is what we're looking in terms of PNH as an add-on to eculizumab, which is the C5 inhibitor, which I'm sure you're familiar with.

這就是我們將 PNH 視為 eculizumab 的附加物，eculizumab 是 C5 抑製劑，我相信你很熟悉。

We're going to be presenting this data at the EBMT Congress at the end of August.

我們將在 8 月底的 EBMT 大會上展示這些數據。

And based on that information, and if results are positive, we would move forward with a Phase III start at the end of this year.

基於這些信息，如果結果是積極的，我們將在今年年底開始第三階段。

Now just backing up one step in terms of the various nephropathies, most of the results will read out in the early part of next year.

現在只是在各種腎病方面倒退一步，大部分結果將在明年年初讀出。

And based on the Phase IIs, if those are positive in both IgA nephropathy and C3 nephropathy, we would quickly pivot to Phase III.

根據 II 期，如果 IgA 腎病和 C3 腎病均呈陽性，我們將迅速轉向 III 期。

So these would be a quick transition from Phase II to Phase III studies in the nephropathies.

因此，這些將是腎病從 II 期研究到 III 期研究的快速過渡。

The next question comes from the line of Florent Cespedes from Societe Generale.

下一個問題來自法國興業銀行的 Florent Cespedes。

Florent Cespedes from Societe Generale.

來自法國興業銀行的 Florent Cespedes。

A quick one for Harry.

給哈利的一個快速的。

Regarding your full year guidance on the top line, could you maybe share with us the main reasons why you have slightly adjusted downwards the sales growth guidance to the low end of the range?

關於您對頂線的全年指導，您能否與我們分享一下您將銷售增長指導略微下調至範圍低端的主要原因？

Is it mainly due to a delay of ofatumumab?

主要是因為ofatumumab的延遲嗎？

Is it due to the softer-than-expected performance of the ophthalmology in Q2 or maybe Sandoz or a bit of everything?

是因為第二季度眼科的表現低於預期，還是 Sandoz 或其他原因？

So any color on that front would be great.

所以前面的任何顏色都會很棒。

Thanks, Florent.

謝謝，弗洛倫特。

Harry?

哈利？

Thank you, Florent.

謝謝你，弗洛倫特。

I mean, clearly, the key change between quarter 1 and quarter 2 now is the impact on the ophthalmology business, which we have to see patients in order to make the injection.

我的意思是，很明顯，第一季度和第二季度之間的關鍵變化是對眼科業務的影響，我們必須看到患者才能進行注射。

And there, we lost quite a bit, if you will.

在那裡，如果你願意的話，我們損失了很多。

I regard this as a one-timer.

我認為這是一次性的。

Now of course, we see end of June, this business to come back.

當然，現在我們看到 6 月底，這項業務要回來了。

It's not yet fully on pre-COVID levels, but it's coming back, right?

它還沒有完全達到 COVID 之前的水平，但它正在回歸，對吧？

And of course, we had a couple of things beforehand that doesn't help us but didn't change our guidance from a range standpoint.

當然，我們事先有幾件事對我們沒有幫助，但從範圍的角度來看並沒有改變我們的指導。

Of course, Beovu, and the other one, as you may recall, as we retained the business in the U.S., the oral solids.

當然，Beovu 和另一個，你可能還記得，因為我們保留了在美國的業務，即口服固體。

That is taking down the growth rates of the company by 1 point.

這使公司的增長率降低了 1 個百分點。

So all of these together.

所以所有這些都在一起。

But the real news is the ophtha part, which moves it more into the mid-single-digit range.

但真正的新聞是 ophtha 部分，它更多地進入了中個位數範圍。

The next question comes from the line of Matt Weston from Crédit Suisse.

下一個問題來自瑞士信貸的 Matt Weston。

Two very quick ones, if I can.

如果可以的話，兩個非常快的。

Vas, you mentioned that you were in final labeling discussions with FDA on ofatumumab.

Vas，您提到您正在與 FDA 就ofatumumab 進行最後的標籤討論。

Given it was filed as an sBLA and Arzerra has a black box warning, should we be expecting a black box warning for ofa?

鑑於它是作為 sBLA 提交的，並且 Arzerra 有黑框警告，我們是否應該期待 ofa 的黑框警告？

And just quickly on Zolgensma, you're now in pricing discussions in Europe.

就在 Zolgensma 上，您現在正在歐洲進行定價討論。

Can you just lay out where the price points have settled in Europe to date?

你能列出迄今為止歐洲的價格點在哪裡穩定嗎？

Thanks, Matthew.

謝謝，馬修。

John, do you want to cover the ofa approach?

約翰，你想介紹 ofa 方法嗎？

Yes.

是的。

So on Arzerra, I think the black box warning specifically refers to both PML cases and HBV reactivation.

所以在 Arzerra，我認為黑框警告特別指 PML 病例和 HBV 再激活。

And looking at the mechanism of ofatumumab, if you think about the overall approach, what we've actually looked at for ofatumumab is the fastest B cell repletion.

看看ofatumumab的機制，如果你考慮整體方法，我們實際上看到的ofatumumab是最快的B細胞補充。

So when patients are actually receiving subcu injections, they have very low and very quick recovery of their B cells.

因此，當患者實際接受 subcu 注射時，他們的 B 細胞恢復非常低且非常快。

So in return, in the studies for ASCLEPIOS I and II, we did not see any cases of PML and we also did not see any cases of HBV reactivation.

因此，作為回報，在 ASCLEPIOS I 和 II 的研究中，我們沒有看到任何 PML 病例，也沒有看到任何 HBV 再激活病例。

So you can -- I think the FDA will accurately reflect what was in our ASCLEPIOS I and II studies.

所以你可以——我認為 FDA 將準確反映我們的 ASCLEPIOS I 和 II 研究中的內容。

And I believe that will be the read-through in terms of how we will have the label moving forward.

我相信這將是我們如何讓標籤向前發展的通讀。

And do you want to also comment on the fact that it's a different brand?

您是否還想評論它是一個不同的品牌這一事實？

Right.

正確的。

And we expect to get a new trade name, which will actually reflect both the efficacy and safety of the label.

我們希望獲得一個新的商標名稱，它實際上將反映標籤的有效性和安全性。

So we will get a new brand name associated with this.

因此，我們將獲得與此相關的新品牌名稱。

So I think this would be a different overall label and brand name for ofatumumab.

所以我認為這將是 ofatumumab 的不同整體標籤和品牌名稱。

And then on Zolgensma European dynamics, overall, right now, our focus has been on early access agreements.

然後關於 Zolgensma 歐洲動態，總體而言，目前，我們的重點一直是早期訪問協議。

Those agreements generally allow us to have an initial payment for the use of the product and then the true-up for final price negotiation.

這些協議通常允許我們對產品的使用進行初始付款，然後對最終價格談判進行調整。

So we're still in the process of securing those pricing negotiations.

因此，我們仍在確保這些定價談判的過程中。

Overall though, the discussions have been very, very positive.

但總的來說，討論非常非常積極。

So I think we're in a good place.

所以我認為我們處在一個好地方。

As I said, 90% of sick funds have supported the use in Germany, early access agreements across Europe.

正如我所說，90% 的病假資金支持在德國使用歐洲各地的早期訪問協議。

You already see that in the sales dynamics in the second quarter.

您已經在第二季度的銷售動態中看到了這一點。

So we remain optimistic that we'll be able to secure pricing in the range of what we had expected.

因此，我們仍然樂觀地認為，我們將能夠確保定價在我們預期的範圍內。

And of course, we'll make those transparent as soon as those negotiations are complete.

當然，一旦這些談判完成，我們就會讓這些變得透明。

Samir here.

薩米爾在這裡。

Just to mention, we're going over the time.

順便提一下，我們要過時了。

So we've got 4 more people on the question list.

所以我們在問題列表上還有 4 個人。

So if you're very quick and we can do it within 30 seconds, that would great.

因此，如果您速度很快，我們可以在 30 秒內完成，那就太好了。

Otherwise, we have a hard stop in 5 minutes.

否則，我們將在 5 分鐘內硬停。

The next question comes from the line of Richard Vosser from JPMorgan.

下一個問題來自摩根大通的 Richard Vosser。

Just a follow-up on LNP203.

只是對 LNP203 的跟進。

The data in the abstract at EBMT shows patients being able to discontinue Soliris and maintaining strong efficacy, I think at least 5 of those patients.

EBMT 的摘要中的數據顯示患者能夠停用 Soliris 並保持強大的療效，我認為這些患者中至少有 5 人。

So just the thought is what's -- when can we actually see some monotherapy data?

所以只是想法是什麼——我們什麼時候才能真正看到一些單一療法的數據？

And would you progress into monotherapy in the Phase III?

你會在第三階段進入單一療法嗎？

Yes.

是的。

So we will disclose the monotherapy data at a future congress.

因此，我們將在未來的大會上披露單藥治療數據。

We do intend to take the medicine forward, both as add-on to eculizumab and as a monotherapy.

我們確實打算將這種藥物作為依庫珠單抗的附加藥物和單一療法向前發展。

The next question comes from the line of Emmanuel Papadakis from Barclays.

下一個問題來自巴克萊銀行的 Emmanuel Papadakis。

Quick one on Cosentyx, if I may.

如果可以的話，在 Cosentyx 上快一點。

You've obviously weathered the storm from the IL-23 relatively successful in terms of them producing a series of (inaudible) in dermatology.

你顯然已經經受住了 IL-23 相對成功的風暴，因為它們在皮膚病學中產生了一系列（聽不清）。

Would a positive head-to-head result from an IL-17 competitor impact your assessment of the robust outlook you outlined earlier?

來自 IL-17 競爭對手的正面正面交鋒結果會影響您對您之前概述的強勁前景的評估嗎？

Yes.

是的。

So I think in the interest of time, I'll quickly take the questions.

所以我想為了時間的緣故，我會很快回答這些問題。

With respect to Cosentyx, our belief is that we have a solid position in dermatology and that the future competitive entrants will not dislodge our overall position, whether it's an IL-17C or F or whatever the next variants are.

關於 Cosentyx，我們的信念是，我們在皮膚病學領域擁有穩固的地位，未來的競爭者不會取代我們的整體地位，無論是 IL-17C 還是 F 或任何下一個變體。

Our focus is to drive both through rheumatology and our new indications as well as what Marie-France laid out, the broad range of additional indications that we have, most notably this year, the approvals in nonradiographic axial SpA.

我們的重點是通過風濕病學和我們的新適應症以及 Marie-France 制定的廣泛的其他適應症，尤其是今年，非放射軸向 SpA 的批准。

I think we've shown we can weather the entry of multiple competitors over time.

我認為我們已經表明，隨著時間的推移，我們可以經受住多個競爭對手的進入。

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

下一個問題來自 Berenberg 的 Kerry Holford。

Just a question on Xiidra, please.

只是一個關於 Xiidra 的問題，拜託。

Just interested to learn what more the regulators in Europe wanted in order to get that approved in that region and why that's prompted you to (inaudible) up on Europe.

只是想了解歐洲監管機構想要在該地區獲得批准的更多信息，以及為什麼這會促使您（聽不清）關注歐洲。

And then also essentially what you assume for the European opportunity within the $3.5 billion price, I think, you paid to Takeda.

然後基本上你對 35 億美元價格內的歐洲機會的假設，我認為，你支付給武田。

And the U.S. is clearly disrupted by COVID.

美國顯然被COVID打亂了。

But I'd be interested to understand what's the next priority to turn that brand around in that market.

但我很想了解在該市場上扭轉該品牌的下一個優先事項是什麼。

Yes.

是的。

Thanks for the question, Kerry.

謝謝你的問題，克里。

Overall, our basis for paying Takeda what we paid was based on the U.S. plan as well as select ex U.S. markets.

總體而言，我們向武田支付我們所支付的費用的依據是基於美國計劃以及選擇的美國以外市場。

It's important to note again, as we've tried to emphasize, we paid an upfront payment, which we thought was very reasonable.

重要的是要再次注意，正如我們試圖強調的那樣，我們支付了預付款，我們認為這是非常合理的。

We only pay the milestones based on strong sales performance.

我們僅根據強勁的銷售業績支付里程碑費用。

And obviously, if we hit those blockbuster milestones, we'd be happy to pay the milestones.

顯然，如果我們達到了那些轟動一時的里程碑，我們很樂意為這些里程碑付出代價。

We did not factor in the EU approval.

我們沒有考慮歐盟的批准。

It was an upside.

這是一個好處。

The European authorities requested additional head-to-head studies, which we don't think it would be worthwhile to pursue.

歐洲當局要求進行額外的面對面研究，我們認為這不值得進行。

So our focus is the OTC -- the DTC campaigns in the U.S., continuing the momentum, 50% access to date and trying to grow that access going forward in Part D. And we are continuing to remain over time optimistic we can get Xiidra to the blockbuster level.

所以我們的重點是場外交易——美國的 DTC 活動，繼續保持勢頭，迄今為止 50% 的訪問量，並試圖在 D 部分繼續增加這種訪問量。隨著時間的推移，我們將繼續保持樂觀，我們可以讓 Xiidra大片級別。

The last question comes from the line of Ronny Gal from Bernstein.

最後一個問題來自 Bernstein 的 Ronny Gal。

Two very quick ones.

兩個非常快的。

Regarding Beovu, is the thinking you will argue for this product with the existing dataset you've created?

關於 Beovu，您會為這個產品與您創建的現有數據集爭論嗎？

Or are there specific -- to generate specifically new preclinical data to address that physician concern?

或者是否有特定的——生成專門的新臨床前數據來解決醫生的擔憂？

And regarding Kymriah, can you discuss the impact of the change in reimbursement by CMS coming in, in October?

關於 Kymriah，您能否討論一下 10 月份 CMS 的報銷變化的影響？

Does it essentially raise the economical benefit for physician about a possible administration versus in-hospital administration?

對於可能的給藥與住院給藥相比，它是否從本質上提高了醫生的經濟效益？

And I know it differs between hospital but overall.

而且我知道這在醫院之間有所不同，但總體而言。

Yes.

是的。

So on Beovu, as Marie-France mentioned, we have a robust team looking at the clinical data, looking at manufacturing, formulation and preclinical data.

因此，正如 Marie-France 所提到的，在 Beovu 上，我們有一個強大的團隊來研究臨床數據、製造、配方和臨床前數據。

It's important to note that there is still a very limited number of cases.

需要注意的是，病例數量仍然非常有限。

And then if you look at the subset of cases with vision loss, as we transparently show on our website, it is a very small subset.

然後，如果您查看視力喪失病例的子集，正如我們在我們的網站上透明顯示的那樣，它只是一個非常小的子集。

So this is a tricky thing to find a precise root cause.

因此，要找到精確的根本原因是一件棘手的事情。

But we do have multiple hypotheses, both from preclinical work as well as clinical work.

但我們確實有多種假設，包括臨床前工作和臨床工作。

And as soon as we have a path forward, of course, on those kinds of approaches, we'll let the community know.

當然，一旦我們有了前進的道路，在這些方法上，我們就會讓社區知道。

I think, as the earlier question cited, Beovu is going to be a long-term journey.

我認為，正如前面提到的問題，Beovu 將是一個長期的旅程。

But given the fact that we believe this medicine can be a very important part of patients maintaining their vision, we are in it for the long term.

但鑑於我們相信這種藥物可以成為患者保持視力的一個非常重要的組成部分，我們將長期參與其中。

In terms of shifts in Kymriah reimbursement in the U.S. I think, of course, the -- we're very pleased by the improvement of hospital reimbursement.

就美國 Kymriah 報銷的變化而言，我認為，當然，我們對醫院報銷的改善感到非常高興。

Overall though, we don't believe this will lead to a significant shift in dynamic, other than hopefully making it easier for the in-hospital use of Kymriah over time.

總體而言，我們不相信這會導致動態的重大轉變，除了希望隨著時間的推移更容易在醫院內使用 Kymriah。

It's important to note that Kymriah can be used in the outpatient setting.

值得注意的是，Kymriah 可用於門診環境。

The vast majority of patients we received are used in the outpatient setting, where it can be used under the Part B program, and we expect that dynamic to continue.

我們收到的絕大多數患者都在門診環境中使用，可以在 B 部分計劃下使用，我們預計這種動態將繼續下去。

Thank you all for the call.

謝謝大家的來電。

Wish everyone good health and well-being, and look forward to keeping you updated at our next quarterly conference call.

祝大家身體健康，幸福安康，並期待在我們的下一個季度電話會議上為您提供最新信息。

Thank you.

謝謝你。

That does conclude our conference for today.

這確實結束了我們今天的會議。

Thank you for participating.

感謝您的參與。

You may all disconnect.

你們都可以斷開連接。