Novartis AG (NVS) 2019 Q1 法說會逐字稿

Good morning, good afternoon, and welcome to the Novartis Q1 2019 Results Release Conference Call and Live Audio Webcast.

早上好，下午好，歡迎來到諾華 2019 年第一季度業績發布電話會議和現場音頻網絡廣播。

(Operator Instructions) And the conference is being recorded.

（操作員說明）會議正在錄製中。

(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.

就此，我想請投資者關係全球主管 Samir Shah 先生髮言。

Please go ahead, sir.

請繼續，先生。

Good afternoon, and good morning, everybody, and thank you for participating in the webcast today.

大家下午好，早上好，感謝大家參加今天的網絡直播。

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

在我們開始之前，我只想向您宣讀安全港聲明。

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前瞻性陳述，涉及已知和未知的風險、不確定性和其他因素。

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明示或暗示的任何未來結果、業績或成就存在重大差異。

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

請參閱公司在美國證券交易委員會備案的 20-F 表格，了解其中一些因素的說明。

And just one other additional point for you for today.

今天還有一點要給你。

If I could please request that you limit yourself to 2 questions at any one time, and if we have additional time at the end of the call, we could provide time for an additional question or 2 at the end.

如果我可以請您在任何時候將自己限制為 2 個問題，並且如果我們在通話結束時有額外的時間，我們可以在結束時提供額外的問題或 2 個問題的時間。

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

然後，我將交給 Vas。

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

謝謝薩米爾，也感謝大家參加今天的電話會議。

Here in Basel, I have with me Shannon Klinger, our Legal Counsel; Susanne Schaffert, the CEO of Novartis Oncology; Paul Hudson, the CEO of Novartis Pharmaceuticals; John Tsai, our Head of Global Drug Development; and Harry Kirsch, our Chief Financial Officer.

在巴塞爾，我有我們的法律顧問 Shannon Klinger；諾華腫瘤業務首席執行官 Susanne Schaffert；諾華製藥公司首席執行官保羅·哈德森； John Tsai，我們的全球藥物開發負責人；和我們的首席財務官 Harry Kirsch。

And as you saw with today's announcement, Novartis is off to a strong start in 2019, if we move to Slide 4. We had strong operational performance with sales growing at 7%, core operating income growing at 18% and our core margin expanding by 2.6%, allowing us to raise our core OpInc guidance, and Harry will go through that in more detail in his presentation.

正如您在今天的公告中看到的那樣，如果我們轉到幻燈片 4，諾華在 2019 年將有一個良好的開端。我們的運營業績強勁，銷售額增長 7%，核心運營收入增長 18%，我們的核心利潤率擴大了2.6%，使我們能夠提高我們的核心 OpInc 指導，Harry 將在他的演講中更詳細地介紹這一點。

We also achieved major innovation milestones in the quarter, including the approval of Mayzent in secondary progressive MS as well as the Zolgensma STR1VE interim analysis, both of which I'll go through in a bit more detail.

我們在本季度還實現了重大創新里程碑，包括 Mayzent 在二次進展 MS 中的批准以及 Zolgensma STR1VE 中期分析，我將更詳細地介紹這兩者。

And lastly and importantly, we continued our transformation to a focused medicines company powered by data science and advanced therapy platform.

最後也是重要的是，我們繼續轉型為一家由數據科學和先進治療平台提供支持的專注醫藥公司。

We complete

我們完成

(technical difficulty)

（技術難度）

We've also announced we'll complete our $5 billion share buyback over the course of 2019.

我們還宣布我們將在 2019 年完成 50 億美元的股票回購。

And lastly, we confirm that we'll continue a strong and growing dividend to be paid in 2019 -- we paid in 2019 of CHF 2.85, and that dividend trend will remain unchanged post the Alcon spin.

最後，我們確認我們將在 2019 年繼續支付強勁且不斷增長的股息——我們在 2019 年支付了 2.85 瑞士法郎，並且股息趨勢在愛爾康分拆後將保持不變。

Now moving to Slide 5. We're starting to deliver operating

現在轉到幻燈片 5。我們開始提供運營

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in Innovative Medicines, in line with what we've told you.

在創新藥物方面，與我們告訴你的一致。

We committed to generating margins in the mid-30% range by 2022.

我們承諾到 2022 年實現 30% 左右的利潤率。

And this quarter, we showed that we're on track to get there with a core margin of 33.3%.

本季度，我們表明我們有望以 33.3% 的核心利潤率實現這一目標。

This margin expansion was driven primarily by

這種利潤增長主要是由

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（技術難度）

in a bit more detail.

更詳細一點。

But also it's worth noting that our launch investments are largely within our existing therapeutic areas, which allows us to leverage our existing infrastructure and scale.

但同樣值得注意的是，我們的啟動投資主要在我們現有的治療領域內，這使我們能夠利用我們現有的基礎設施和規模。

Also I'm quite pleased with the progress we're making on Novartis technical operations and Novartis business services in terms of the productivity initiatives, which are now really starting to kick in, in the P&L.

此外，我對我們在生產力舉措方面在諾華技術運營和諾華業務服務方面取得的進展感到非常高興，這些舉措現在真正開始在損益表中發揮作用。

And lastly, we were able to hold our core R&D cost at the level of 20%.

最後，我們能夠將核心研發成本控制在 20% 的水平。

As we stated in the past, our goal is to

正如我們過去所說，我們的目標是

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（技術難度）

Innovative Medicines that may fluctuate based on pipeline opportunities, but it's I think positive trend to show that we are in that range now, and we expect to be there moving ahead.

創新藥物可能會根據管道機會而波動，但我認為這是一個積極的趨勢，表明我們現在處於這個範圍內，我們預計會繼續前進。

Now moving to Slide 6. We saw a continued sales momentum in Innovative Medicines.

現在轉到幻燈片 6。我們看到創新藥物的持續銷售勢頭。

Cosentyx and Entresto both delivered strong growth in the quarter, and we'll talk a little bit more about that.

Cosentyx 和 Entresto 在本季度都實現了強勁增長，我們將對此進行更多討論。

Our Oncology growth drivers all performed well -- as well also in the quarter with Lutathera, in particular, showing a very strong performance, consistent with our expectation for this medicine to become a blockbuster.

我們的腫瘤學增長動力都表現良好——尤其是在本季度，Lutathera 表現非常強勁，這與我們對該藥物成為重磅炸彈的預期一致。

Now moving to Slide 7 and diving in a bit deeper on Cosentyx.

現在轉到幻燈片 7 並深入了解 Cosentyx。

We demonstrated strong growth in the quarter of 41%.

我們在本季度實現了 41% 的強勁增長。

And you can look at this from the U.S. perspective and the ex U.S. perspective.

你可以從美國的角度和前美國的角度來看這個問題。

In the U.S. perspective, we had 37% TRx growth versus prior year and 49% sales growth, which really demonstrates we continue our outstanding momentum with Cosentyx in the United States.

從美國的角度來看，我們的 TRx 與上一年相比增長了 37%，銷售額增長了 49%，這確實表明我們在美國繼續保持與 Cosentyx 的出色勢頭。

We also saw strong growth across indications outside the United States.

我們還看到美國以外的適應症出現強勁增長。

Importantly, we received approval in psoriasis in March in China, and we expect to launch in the second half in 2019, allowing us to continue that out -- momentum outside the United States.

重要的是，我們於 3 月在中國獲得銀屑病批准，我們預計將在 2019 年下半年推出，讓我們能夠繼續保持這種勢頭——美國以外的勢頭。

Now going a bit deeper into the United States for Cosentyx on Slide 8. We saw a continued share momentum, both in psoriasis and in spondyloarthritis.

現在在幻燈片 8 上更深入地了解 Cosentyx。我們看到了牛皮癬和脊柱關節炎的持續份額勢頭。

If you look at the left-hand side of the chart, in dermatology, and our key competitive set, we have a market share now in NBRx of 19%.

如果你看一下圖表的左側，在皮膚病學和我們的主要競爭組合中，我們現在在 NBRx 中的市場份額為 19%。

And in terms of NBRx growth, we're outperforming the U.S. market.

就 NBRx 的增長而言，我們的表現優於美國市場。

We continue to lead in TRx among new entrants in the U.S. And we're also on track to read out the ARROW study at the end of this year, providing additional data to support the rapid onset of Cosentyx.

在美國新進入者中，我們繼續在 TRx 方面處於領先地位。我們也有望在今年年底宣讀 ARROW 研究，提供更多數據來支持 Cosentyx 的快速起效。

In terms of rheumatology, we surpassed HUMIRA in TRx in ankylosing spondylitis and psoriatic arthritis, demonstrating an NBRx share of 43% versus HUMIRA's 20%.

在風濕病學方面，我們在強直性脊柱炎和銀屑病關節炎的 TRx 方面超過了 HUMIRA，表明 NBRx 的份額為 43%，而 HUMIRA 為 20%。

And our non-radiographic axial SpA readout is on track for the back half of 2019.

我們的非射線軸位 SpA 讀數有望在 2019 年下半年實現。

So strong performance, strong momentum in Cosentyx, and we're really pleased with where we are with this medicine.

Cosentyx 的表現如此強勁，勢頭強勁，我們對這種藥物的現狀感到非常滿意。

Moving to Slide 9. When you look at Entresto, we had strong Q1 sales growth with all -- an all-time high of 3,900 scripts from an NBRx endpoint in Q1.

轉到幻燈片 9。當你看 Entresto 時，我們第一季度的銷售增長強勁——第一季度來自 NBRx 端點的 3,900 個腳本創歷史新高。

This underlying demand was really driven by the additional data that we've generated on quality of life as well as the impact of Entresto initiation in the hospital, which we showed through the PIONEER-HF study.

這種潛在的需求實際上是由我們產生的關於生活質量的額外數據以及我們通過 PIONEER-HF 研究展示的 Entresto 在醫院的影響所驅動的。

That data is now being disseminated across geographies and helps continue to support the broader use of Entresto.

這些數據現在正在跨地區傳播，並有助於繼續支持 Entresto 的更廣泛使用。

We have the readout of the PARAGON-HF study in preserved ejection fraction heart failure on track for the second half.

我們有 PARAGON-HF 研究在下半年進行的保留射血分數心力衰竭的讀數。

And I wanted to highlight as well our performance in China.

我還想強調我們在中國的表現。

Entresto, based on the estimates that we have in-house, is arguably the best launch of a primary care drug in China since 1999 when we actually have data available.

根據我們內部的估計，Entresto 可以說是自 1999 年我們實際掌握數據以來在中國推出的最佳初級保健藥物。

This is -- in a context, we do not have reimbursement yet in China.

這是 - 在某種情況下，我們在中國還沒有報銷。

We -- a national reimbursement yet in China.

我們——中國還沒有國家報銷。

We expect, in China alone, Entresto to be a significant medicine, and we'll continue to watch that and provide you updates as our performance in China continues to progress.

我們預計，僅在中國，Entresto 就會成為一種重要的藥物，隨著我們在中國的業績不斷取得進展，我們將繼續關注這一點並為您提供最新消息。

Now moving to Slide 10.

現在轉到幻燈片 10。

Oncology also had a very strong quarter growing 9% in constant currency, and this was driven by our full range of growth drivers.

腫瘤學也有一個非常強勁的季度，按固定匯率計算增長了 9%，這是由我們全方位的增長動力推動的。

Promacta/Revolade, Jakavi and Tafinlar and Mekinist all performed well in the quarter, continuing their previous trajectory given their strong data sets to support their broad use.

Promacta/Revolade、Jakavi 和 Tafinlar 以及 Mekinist 在本季度均表現良好，鑑於其強大的數據集支持其廣泛使用，延續了之前的軌跡。

I wanted to highlight in particular the performance of Lutathera.

我想特別強調 Lutathera 的性能。

Our total sales in Lutathera in the quarter were $106 million.

本季度我們在 Lutathera 的總銷售額為 1.06 億美元。

Our AAA sales were $163 million.

我們的 AAA 銷售額為 1.63 億美元。

We've reached over 2,000 new patients since launch in the U.S. And we have positive momentum as well in the European Union with reimbursement and access in the U.K., Italy as well as other markets.

自從在美國推出以來，我們已經接觸了 2,000 多名新患者。我們在歐盟以及在英國、意大利和其他市場的報銷和准入方面都有積極的勢頭。

Taken together, I think this demonstrates our investment in the radioligand therapy platform is truly a platform investment that we can build on.

總而言之，我認為這表明我們對放射配體治療平台的投資確實是我們可以建立的平台投資。

And we look forward to now advancing a broader pipeline, including life cycle management of Lutathera in additional indication as well as moving forward in other solid tumors using radioligand technology.

我們現在期待著推進更廣泛的管道，包括 Lutathera 的生命週期管理在額外的適應症以及使用放射配體技術在其他實體瘤中取得進展。

Now moving to Slide 11.

現在轉到幻燈片 11。

We have 10-plus potential blockbusters, which we've been discussing with you planned until 2021 and over 25 in late-stage development; so really fully stocked pipeline.

我們有 10 多部潛在的大片，我們一直在與您討論計劃到 2021 年，還有超過 25 部處於後期開發階段；所以真的儲備充足的管道。

Now some of the important milestones we achieved in the quarter, I'll go through now in a bit more detail, starting on Slide 12.

現在，我將從幻燈片 12 開始，更詳細地介紹我們在本季度實現的一些重要里程碑。

Mayzent launched in the U.S. with what we really believe is a unique efficacy data set.

Mayzent 在美國推出，我們真正相信這是一個獨特的功效數據集。

And I think it's important to keep reminding the group on the phone as well as the broader community that we are the only medicine ever to have successfully been studied in secondary progressive MS. This is a patient population that is older, that has higher EDSS scores and to date has not had an improved therapy.

我認為，重要的是要不斷通過電話提醒小組以及更廣泛的社區，我們是唯一一種在二次進展型 MS 中成功研究過的藥物。這是一個年齡較大的患者群體，具有較高的 EDSS 評分，並且迄今為止還沒有改進的治療方法。

We believe (inaudible) that we specifically studied this patient population gives us a unique value proposition and a unique differentiating feature.

我們相信（聽不清）我們專門研究了這個患者群體，為我們提供了獨特的價值主張和獨特的差異化特徵。

So in our labeling, it was made clear, as you can see in the diagram on the right, that across all the relevant data sets -- data subcuts, there was a trend towards favoring Mayzent in the study.

因此，在我們的標籤中，很明顯，正如您在右圖中看到的那樣，在所有相關數據集——數據子切割中，研究中有一種傾向於 Mayzent 的趨勢。

And also importantly, no first dose observation is expected for around 70% of the patient population.

同樣重要的是，預計約 70% 的患者不會進行首次劑量觀察。

It's early days, and I think Paul can comment further on how we're progressing on the Mayzent launch.

現在還處於早期階段，我認為 Paul 可以進一步評論我們在 Mayzent 發布方面的進展情況。

But we're pleased with where we are, and we look forward to giving you further updates over the course of the year.

但我們對我們所處的位置感到滿意，我們期待在這一年中為您提供進一步的更新。

I'd like -- now I'd like to turn to Zolgensma and go through a couple of slides to really clarify some of the points on Zolgensma's recent data.

我想——現在我想轉向 Zolgensma 並通過幾張幻燈片來真正澄清 Zolgensma 最近數據的一些觀點。

So moving to Slide 13.

所以轉到幻燈片 13。

The STR1VE interim data we recently reported, we believe, fully supports Zolgensma as the foundational therapy for SMA Type 1. The efficacy data was consistent with the START trial.

我們相信，我們最近報告的 STR1VE 中期數據完全支持 Zolgensma 作為 1 型 SMA 的基礎療法。療效數據與 START 試驗一致。

Here you see the STR1VE patients overlaid on the START patients.

在這裡，您可以看到 STR1VE 患者疊加在 START 患者上。

Of course, there are variabilities in terms of starting point, in terms of the CHOP INTEND scores at baseline, so you will see some variability in CHOP INTEND scores.

當然，就基線的 CHOP INTEND 分數而言，起始點存在差異，因此您會看到 CHOP INTEND 分數存在一些差異。

But overall, in our discussions with investigators, we believe this demonstrates the strong performance of the medicine.

但總的來說，在我們與研究人員的討論中，我們認為這證明了該藥物的強大性能。

And we'd expect, as we continue to follow these patients, we'll see continued improvements, we would expect, in their CHOP INTEND scores, demonstrating the rapid -- early and rapid increase of the medicine and continued motor milestones being reached over the course of the life of these patients.

我們希望，隨著我們繼續跟踪這些患者，我們會看到他們的 CHOP INTEND 分數持續改善，表明藥物的快速 - 早期和快速增加以及持續達到運動里程碑這些患者的生命歷程。

The safety was comparable to the START study as well.

安全性也與 START 研究相當。

I'll go through the safety data in a bit more detail in an upcoming slide.

我將在即將發布的幻燈片中更詳細地介紹安全數據。

But there was a single death in the STR1VE study, but this was a respiratory failure, completely unrelated to treatment.

但是STR1VE研究中出現了一個死亡案例，但這是呼吸衰竭，與治療完全無關。

And we had a significant CHOP-INTEND increase in this patient of 27, demonstrating the impact of the medicine in the patient, despite the very unfortunate circumstances of the patient's death.

我們對這名 27 歲的患者進行了顯著的 CHOP-INTEND 增加，證明了藥物對患者的影響，儘管患者死亡的情況非常不幸。

Then moving to Slide 14.

然後轉到幻燈片 14。

One of the things we learned through further assessment of the patient who unfortunately died in the STR1VE study is that there was widespread SMN expression comparable to unaffected individuals after Zolgensma therapy.

通過對在 STR1VE 研究中不幸死亡的患者的進一步評估，我們了解到的一件事是，在接受 Zolgensma 治療後，SMN 的廣泛表達與未受影響的個體相當。

I think it's really important to fully understand this data as it demonstrates mechanistically from a pharmacodynamic standpoint that Zolgensma reaches all of the target tissue, both in the central nervous system as well as the other organs examined.

我認為完全理解這些數據非常重要，因為它從藥效學的角度從機制上證明 Zolgensma 可以到達所有目標組織，包括中樞神經系統和其他檢查的器官。

And it achieves a situation where the expression of the SMN protein is comparable to uninfected individuals.

並且實現了SMN蛋白的表達量與未感染個體相當的情況。

You can see on the chart here on the left-hand side of the diagram a non-SMA subject, a normal subject.

您可以在圖表左側的圖表上看到一個非 SMA 對象，一個正常對象。

You can see what's normal SMN expression looks like.

您可以看到正常的 SMN 表達式是什麼樣子的。

You can see a nontreated SMA subject with really no expression of SMN.

您可以看到一個未處理的 SMA 對象，實際上沒有 SMN 的表達。

And you can see how Zolgensma, a single infusion IV of Zolgensma achieved strong SMN expression across all target tissues shown here as well as other organs in the body.

您可以看到 Zolgensma，Zolgensma 的單次輸注 IV 如何在此處顯示的所有目標組織以及身體的其他器官中實現強烈的 SMN 表達。

So I think that -- we believe really definitely shows that Zolgensma can restore SMN expression to motor neurons that lack a functional SMN1 gene.

所以我認為——我們相信確實表明 Zolgensma 可以恢復缺乏功能性 SMN1 基因的運動神經元的 SMN 表達。

Now moving to Slide 15.

現在轉到幻燈片 15。

There's been a lot of, I think, questions raised regarding the safety profile, so I wanted to go through this in a bit more detail.

我認為，關於安全概況提出了很多問題，所以我想更詳細地討論一下。

The overall safety data we see fully supports a strong benefit-risk profile of Zolgensma in what is a very fragile patient population.

我們看到的總體安全性數據完全支持 Zolgensma 在非常脆弱的患者群體中的強大收益-風險概況。

It's worth remembering that from a natural history standpoint, SMA Type 1 has only a 50% survival at 10 months of age and about an 8% survival at 20 months of age.

值得記住的是，從自然歷史的角度來看，1 型 SMA 在 10 個月大時的存活率僅為 50%，在 20 個月大時的存活率約為 8%。

These are very ill children.

這些都是病得很重的孩子。

Deaths are commonly reported.

死亡的報導很普遍。

If you look at the labeling of our -- the competitor therapy as well as the clinical trials of the other investigational therapies, you will see deaths reported in their clinical trials.

如果您查看我們的標籤 - 競爭療法以及其他研究療法的臨床試驗，您會看到他們的臨床試驗中報告的死亡人數。

So this is something that comes with trying to treat patients who are in a very fragile, desperate state.

因此，這是試圖治療處於非常脆弱、絕望狀態的患者所帶來的結果。

Today, we have 151 Zolgensma patients dosed in our studies, and you can see the breakdown here across the various subtypes and the various settings.

今天，我們有 151 名 Zolgensma 患者在我們的研究中服用，您可以在此處看到各種亞型和各種設置的細分。

Overall, Zolgensma is generally safe and well tolerated.

總體而言，Zolgensma 通常是安全且耐受性良好的。

And the real key is that appropriate care is provided.

真正的關鍵是提供適當的護理。

I discussed already the first steps that had a 27-point improvement in CHOP-INTEND.

我已經討論了在 CHOP-INTEND 中有 27 點改進的第一步。

It was ultimately determined to be unrelated to therapy.

最終確定與治療無關。

In our European STR1VE study, we did have a case of a death that occurred in January 2019, and we're really working through the final assessment to determine was there any potential contribution of AVXS-101 to this death.

在我們的歐洲 STR1VE 研究中，我們確實有一例發生在 2019 年 1 月的死亡病例，我們確實正在通過最終評估來確定 AVXS-101 是否對這起死亡有任何潛在貢獻。

It's important to note, as always, when investigators can't completely exclude the contribution of any study medication, they are required to code the medicine as being potentially contributing to the death.

與往常一樣，重要的是要注意，當研究人員不能完全排除任何研究藥物的作用時，他們需要將藥物編碼為可能導致死亡的藥物。

This is normal in all clinical trials.

這在所有臨床試驗中都是正常的。

It's just in this instance we have an open-label study.

正是在這種情況下，我們進行了一項開放標籤研究。

And hence, this is more transparent.

因此，這更加透明。

We provided regulatory authorities and our data safety monitoring board full information in January as well as in early February, and all were aligned and no action was required.

我們在 1 月和 2 月初向監管機構和我們的數據安全監督委員會提供了完整的信息，所有信息都是一致的，不需要採取任何行動。

The study continued per protocol.

該研究按照方案繼續進行。

We are -- we have continued to advise physicians that they need to carefully consider the state of the patient before providing Zolgensma.

我們——我們繼續建議醫生，他們在提供 Zolgensma 之前需要仔細考慮患者的狀況。

But we, of course, always want to enable this medicine to be available when there is a hope for a child to potentially achieve a transformational result.

但是，當然，我們總是希望在孩子有希望獲得潛在的轉化結果時能夠使用這種藥物。

So this particular patient was dosed at 5 months of age, had swallowing difficulties at baseline, had a potential aspiration pneumonia already at baseline, so already a complicated course.

所以這個特定的患者在 5 個月大時接受了給藥，在基線時有吞嚥困難，在基線時已經有潛在的吸入性肺炎，所以已經是一個複雜的過程。

I think the -- heroically, the physician and the parents decided to try to do anything they could for the child and enrolled them in the STR1VE study.

我認為——英勇地，醫生和父母決定嘗試為孩子做任何他們能做的事，並讓他們參加 STR1VE 研究。

Within 14 days, there were secretions that were positive for 5 respiratory infectious agents, including RSV, which, many of you will know, is a very important cause of respiratory distress in children and respiratory death in children.

在 14 天內，分泌物對 5 種呼吸道傳染物呈陽性，其中包括 RSV，你們中的許多人都知道，RSV 是導致兒童呼吸窘迫和兒童呼吸系統死亡的一個非常重要的原因。

The patient subsequently died of disseminated sepsis, and an -- autopsy results are pending.

該患者隨後死於播散性敗血症，屍檢結果正在等待中。

And of course, when we have those autopsy results, we can definitively determine was there any contribution of AVXS-101 on top of the already complicated situation, including all the infectious agents and the potential -- the sepsis in the patient.

當然，當我們得到這些屍檢結果時，我們可以明確地確定 AVXS-101 在已經很複雜的情況下是否有任何貢獻，包括所有的傳染源和潛在的——病人的敗血症。

Now moving to Slide 16.

現在轉到幻燈片 16。

There are over 150 patients treated now with Zolgensma, as we noted.

正如我們所指出的，現在有超過 150 名患者接受 Zolgensma 治療。

And importantly, only 5% have been excluded today due to AAV9 antibody titers.

重要的是，由於 AAV9 抗體滴度，今天只有 5% 被排除在外。

And we believe this is an important element for your models to understand that, actually, the exclusion criteria for the use of AVXS-101 is actually lower than we have previously guided.

我們相信這是讓您的模型了解的一個重要因素，實際上，使用 AVXS-101 的排除標準實際上低於我們之前指導的標準。

We've only had 9 of 177 patients screened to date with exclusionary titers, and you could see the MDA 2019 data presentation elevated AAV9 antibody titers at screening should not affect the ability of the vast majority of infants with SMA to receive treatment.

迄今為止，我們在篩查的 177 名患者中只有 9 名具有排他性滴度，您可以看到 MDA 2019 數據顯示，篩查時升高的 AAV9 抗體滴度不應影響絕大多數患有 SMA 的嬰兒接受治療的能力。

So we feel like this is an important element now of the story that the vast majority of children should be able to achieve -- to receive AVXS-101.

所以我們覺得這是絕大多數兒童應該能夠實現的故事的一個重要元素——接受 AVXS-101。

Now moving to Slide 17.

現在轉到幻燈片 17。

We have established readiness ahead of our U.S. approval, expected now in May for our PDUFA date.

我們已經在美國批准之前做好準備，預計現在是 5 月份的 PDUFA 日期。

As you can see, from an institutional standpoint, we have delivery infrastructure set up.

正如您所看到的，從制度的角度來看，我們已經建立了交付基礎設施。

We're set up for rapid product delivery.

我們已準備好快速交付產品。

We've already reached the 60 top centers.

我們已經達到了 60 個頂級中心。

And we're ready to cover 80% of infants with SMA.

我們已準備好覆蓋 80% 的患有 SMA 的嬰兒。

We're continuing to build supply with the acquisition of a manufacturing site in Colorado.

我們通過收購科羅拉多州的製造基地繼續建立供應。

We have over 1 million square feet now manufacturing space and preparing that space to continue to ramp up production.

我們現在擁有超過 100 萬平方英尺的製造空間，並準備好該空間以繼續提高產量。

We've engaged over 70 payers in discussions, covering 80% of the SMA infant population and expect to have contracts in place at launch to cover 30% of commercial lives.

我們已經與 70 多家付款人進行了討論，涵蓋了 80% 的 SMA 嬰兒人口，並預計在推出時簽訂合同，以覆蓋 30% 的商業生活。

So all, I think in line with world-class launch preparation by Paul Hudson and his team.

所以，我認為這與 Paul Hudson 和他的團隊進行的世界級發射準備工作是一致的。

So moving to Slide 18.

所以轉到幻燈片 18。

BYL is another important milestone for the company in Oncology.

BYL 是公司在腫瘤學領域的另一個重要里程碑。

And I think it's important to note, after HER2-positive status and hormone-receptor positive status, we expect PI3 kinase mutation status to become another linchpin of care for patients with metastatic breast cancer.

而且我認為值得注意的是，在 HER2 陽性狀態和激素受體陽性狀態之後，我們預計 PI3 激酶突變狀態將成為轉移性乳腺癌患者護理的另一個關鍵。

In this study, we demonstrated, for the first time, a genetically driven treatment could be used in the breast cancer setting.

在這項研究中，我們首次證明了可以在乳腺癌環境中使用基因驅動的治療方法。

We anticipate to be launching later this year, though we're in discussions with the continuous assessment process with FDA in an ongoing basis.

我們預計將在今年晚些時候推出，儘管我們正在與 FDA 持續討論持續評估流程。

We also anticipate to launch with an FDA-approved companion diagnostic for the PI3 kinase test as well as we've engaged payers to cover over 80% of the target population.

我們還預計將推出 FDA 批准的 PI3 激酶測試伴隨診斷，並且我們已經與付款人合作以覆蓋超過 80% 的目標人群。

So again, we're ready for a strong launch.

因此，我們再次準備好進行強有力的發布。

This launch will be initially a bit slower as we try to achieve strong testing coverage, but then we expect a strong uptake in the future.

由於我們試圖實現強大的測試覆蓋率，因此此次發布最初會稍微慢一些，但我們預計未來會出現強勁的增長。

Now moving to Slide 19.

現在轉到幻燈片 19。

I wanted to also just briefly highlight some new data with respect to fevipiprant, our DP2 antagonist, which showed asthma disease-modifying potential in a recent study.

我還想簡單地強調一些關於我們的 DP2 拮抗劑 fevipiprant 的新數據，它在最近的一項研究中顯示出改善哮喘疾病的潛力。

So if you look at the left side of this graph, you can see a readout from Science Translational Medicine that demonstrated fevipiprant was the first studied medication to impact airway smooth muscles in patients with asthma.

因此，如果您查看此圖的左側，您可以看到來自科學轉化醫學的讀數，該讀數表明 fevipiprant 是第一個研究的影響哮喘患者氣道平滑肌的藥物。

This is a disease-modifying effect in patients.

這是對患者的疾病緩解作用。

The first time it's been, to our understanding, demonstrated by biologics or small molecules.

據我們了解，這是第一次由生物製品或小分子證明。

It indicates again why we think this is -- could be a very important medicine pending the Phase III readouts.

它再次表明為什麼我們認為這可能是一種非常重要的藥物，等待 III 期讀數。

You can see on the right-hand side, we have a full range of trials covering exacerbation, lung function and safety.

您可以在右側看到，我們進行了涵蓋惡化、肺功能和安全性的全方位試驗。

And we're looking forward to providing additional data readouts later this year on what we believe will be a very exciting medicine for the company.

我們期待在今年晚些時候提供更多的數據讀數，我們認為這對公司來說將是一種非常令人興奮的藥物。

Now lastly, before handing it over to Harry, I wanted to welcome Richard Saynor, our new Sandoz CEO and member of the executive committee.

最後，在將它交給 Harry 之前，我想歡迎 Richard Saynor，我們的新任 Sandoz 首席執行官兼執行委員會成員。

Richard joins us from GSK, where he is the Senior Vice President of Classic and Established Products, overseeing an approximately $10 billion off-patent medicines business at GSK.

理查德從 GSK 加入我們，他是經典和成熟產品的高級副總裁，負責監督 GSK 約 100 億美元的非專利藥品業務。

Previous to that, he was at Sandoz, where he oversaw region international in the Latin American region, so understands well Sandoz, Sandoz headquarters and understands Sandoz legacy and Sandoz footprint.

在此之前，他在 Sandoz 工作，負責拉丁美洲地區的區域國際業務，因此非常了解 Sandoz、Sandoz 總部，並了解 Sandoz 的遺產和 Sandoz 足跡。

He brings an experience of 20-year-plus years in the space, along with a real track record of building successful teams.

他帶來了在該領域 20 多年的經驗，以及建立成功團隊的真實記錄。

So we're looking forward to having him join in Q3 to enable us to drive the Sandoz transformation.

因此，我們期待他加入第三季度，使我們能夠推動 Sandoz 轉型。

And with that, I will hand it over to Harry.

有了這個，我會把它交給哈利。

Harry?

哈利？

All right.

好的。

Thank you, Vas.

謝謝你，瓦斯。

Good morning, and good afternoon, everyone.

大家早上好，下午好。

Please note that my comments reflect the results of continuing operations and growth rates in constant currencies, unless I note otherwise.

請注意，除非我另有說明，否則我的評論反映了持續經營的結果和以固定貨幣計算的增長率。

To assist with your modeling, the 2018 and 2017 results from continuing operations are now available on our website.

為協助您進行建模，我們的網站現已提供 2018 年和 2017 年持續經營業績。

So Slide 22 shows the summary of our strong quarter 1 continuing operations performance, which excludes the Alcon business.

所以幻燈片 22 顯示了我們強勁的第一季度持續運營業績的總結，其中不包括愛爾康業務。

Sales grew plus 7%, mainly driven by the continued excellent momentum from all of our key growth drivers, including Cosentyx, Entresto and Lutathera, as well as growth from Promacta, Kisqali, Kymriah and Taf/Mek.

銷售額增長了 7%，主要是由於我們所有主要增長動力的持續強勁勢頭，包括 Cosentyx 、 Entresto 和 Lutathera ，以及 Promacta 、 Kisqali 、 Kymriah 和 Taf / Mek 的增長。

Also Lucentis, Xolair and Ilaris grew double digits, even established medicines, like Galvus, Diovan, Exforge contributed to growth.

Lucentis、Xolair 和 Ilaris 也實現了兩位數的增長，甚至 Galvus、Diovan、Exforge 等成熟藥物也為增長做出了貢獻。

Overall, in quarter 1, we saw excellent execution by our pharma and oncology teams, driving significant sales growth of our large products and a vast majority of our 15 in-market blockbusters.

總體而言，在第一季度，我們看到了我們的製藥和腫瘤學團隊的出色執行，推動了我們的大型產品和我們 15 種市場重磅炸彈中的絕大多數的銷售顯著增長。

Core operating income grew plus 18%.

核心營業收入增長了 18%。

This was clearly driven by good sales momentum.

這顯然是由良好的銷售勢頭推動的。

In addition, we see our productivity programs kicking in, driving up gross margin and driving down total function cost as a percent of sales.

此外，我們看到我們的生產力計劃開始發揮作用，提高了毛利率並降低了總職能成本佔銷售額的百分比。

As a result, sales growth and productivity programs more than offset increased investments, including pre-launch investments for Zolgensma.

因此，銷售增長和生產力計劃足以抵消增加的投資，包括對 Zolgensma 的上市前投資。

Operating income and net income grew 4% impacted by a net impairment charge and lower divestment gains this year versus prior year.

營業收入和淨收入增長 4%，受淨減值費用和今年與上一年相比較低的撤資收益的影響。

Free cash flow was $1.9 billion, broadly in line with prior year.

自由現金流為 19 億美元，與上年基本持平。

Please recall that quarter 1 2018 had a onetime sales milestone receipt of $0.4 billion.

請回想一下，2018 年第一季度的一次性銷售里程碑收入為 4 億美元。

On Slide 23, you see the resulting core margin expansion in quarter 1 of 260 basis points for both Innovative Medicines and continuing operations.

在幻燈片 23 上，您可以看到第一季度創新藥物和持續經營業務的核心利潤率增長了 260 個基點。

Let me briefly comment on 2 of our major productivity programs.

讓我簡要評論一下我們的兩個主要生產力計劃。

Novartis technical operations transformation and resulting manufacturing efficiencies as well as favorable mix drove gross margin improvements.

諾華（Novartis）技術運營轉型和由此產生的製造效率以及有利的組合推動了毛利率的提高。

Novartis Business Services also contributed to core margin expansion with continued efforts on standardization and footprint optimization, as we leverage even more our global shared service centers.

隨著我們更多地利用我們的全球共享服務中心，諾華商業服務還通過在標準化和足跡優化方面的持續努力為核心利潤率的擴張做出了貢獻。

Innovative Medicines core margin expanded to 33.3%.

創新藥物核心利潤率擴大至 33.3%。

This puts us real nicely on track for the mid-30s margin goal by 2022.

這使我們真正走上了到 2022 年實現 30 年代中期利潤率目標的軌道。

Sandoz margin also grew as gross margin improvements more than offset the U.S. pricing pressures.

Sandoz 的利潤率也有所增長，因為毛利率的提高抵消了美國的定價壓力。

Before we come to our updated full year guidance, please keep in mind that we expect to see higher generic headwinds in the upcoming quarters.

在我們發布更新後的全年指引之前，請記住，我們預計在接下來的幾個季度會出現更大的通用逆風。

This is mainly expected in our Oncology business on Exjade and Afinitor.

這主要是在我們的 Exjade 和 Afinitor 腫瘤學業務中預期的。

In addition, we continue to monitor Sandostatin LAR.

此外，我們繼續監測 Sandostatin LAR。

Also some of the quarter 1 growth in Diovan and Exforge was mainly due to competitive supply issues and may not continue.

此外，Diovan 和 Exforge 第一季度的部分增長主要是由於競爭性供應問題，可能不會持續下去。

On Slide 24, you see our updated 2019 full year guidance for the new focused medicines company.

在幻燈片 24 上，您可以看到我們為這家新的重點藥品公司更新的 2019 年全年指南。

This excludes Alcon and Sandoz U.S. dermatology and oral solids portfolio for the full year in both 2018 and 2019.

這不包括 2018 年和 2019 年全年的愛爾康和山德士美國皮膚科和口服固體產品組合。

In short, we are confirming our sales guidance at mid-single-digit.

簡而言之，我們正在確認我們的銷售指導處於中等個位數。

As Vas mentioned earlier, we are raising our core operating income guidance to grow high single digits following the strong quarter 1 performance.

正如 Vas 之前提到的，在第一季度的強勁表現之後，我們正在提高我們的核心營業收入指引，以實現高個位數增長。

Some of you asked this morning what's to base the guidance for the new focused medicines company off in 2018, so let me give you some hopefully helpful details.

你們中的一些人今天早上問到 2018 年新的重點藥品公司的指導方針是什麼，所以讓我給你們一些希望有用的細節。

So Alcon is excluded from continuing operations, so that's straightforward.

所以愛爾康被排除在持續經營之外，所以這很簡單。

The to-be divested U.S. generic business generated, we said prior, $1.2 billion, some of you asked for very details on that.

我們之前說過，即將剝離的美國仿製藥業務產生了 12 億美元，你們中的一些人要求提供非常詳細的信息。

It's $1.174 billion of sales in 2018.

2018 年的銷售額為 11.74 億美元。

And the core operating income, where we said $0.3 billion, is $294 million of core operating income in 2018.

我們所說的核心營業收入為 3 億美元，是 2018 年核心營業收入的 2.94 億美元。

So I hope that's helpful as you model the new focused medicines company.

因此，我希望這對您為新的重點藥品公司建模時有所幫助。

Now with continued good momentum, we could finish 2019 at the upper end of our sales and core operating income ranges.

現在，憑藉持續的良好勢頭，我們可以在 2019 年的銷售額和核心營業收入範圍的上限結束。

As we will be -- also we need to consider the upcoming results for our catalyst-rich pipeline in 2019.

正如我們將要做的那樣——我們還需要考慮 2019 年我們富含催化劑的管道即將取得的結果。

This will allow us a bit later in the year to continue to fine tune our full year guidance.

這將使我們能夠在今年晚些時候繼續微調我們的全年指導。

On Slide 25, you see how currencies would impact our results if mid-April rates prevail for the remainder of 2019.

在幻燈片 25 上，您可以看到如果 4 月中旬的利率在 2019 年剩餘時間內占主導地位，貨幣將如何影響我們的結果。

The full year impact on sales would be negative -- minus 3%.

全年對銷售額的影響將是負面的——-3%。

And on core operating income, we would have minus 3% to minus 4% negative impact.

在核心營業收入方面，我們將產生負 3% 至負 4% 的負面影響。

As you can see on the slide, the negative currency impact is more pronounced the first half of the year as the U.S. dollar strengthened mainly during quarter 3 of last year.

正如您在幻燈片中看到的那樣，由於美元主要在去年第三季度走強，今年上半年貨幣的負面影響更為明顯。

And as a reminder, the expected currency impact is updated on our website monthly.

提醒一下，預期的貨幣影響每月都會在我們的網站上更新。

And with that, I hand it back to Vas.

然後，我將它交還給 Vas。

Thank you, Harry.

謝謝你，哈利。

So appreciate the great interest in the company.

所以感謝對公司的極大興趣。

We've had an outstanding, I think, start to the year.

我認為，我們今年的開局非常出色。

And we look forward to answering your questions.

我們期待著回答您的問題。

So operator, we can open the line for questions.

接線員，我們可以打開問題熱線。

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

（操作員說明）您的第一個問題來自美國銀行的 Graham Parry。

So I've got one question on Gilenya and then one on Zolgensma.

所以我有一個關於 Gilenya 的問題，然後是一個關於 Zolgensma 的問題。

So firstly on Gilenya, could you just remind us where you are in your arbitration negotiations with Mitsubishi in terms of Gilenya royalties?

那麼首先關於 Gilenya，您能否提醒我們您與三菱就 Gilenya 特許權使用費進行仲裁談判的進展情況？

I see they stopped booking their royalties overnight pending the outcome of arbitration.

我看到他們在等待仲裁結果之前一夜之間停止了版稅。

So can you confirm, are you continuing to book royalties in your numbers?

那麼你能確認一下，你是否繼續在你的號碼中預訂版稅？

And what assumption on royalty post the August composition of matter patent expiry is baked into your guidance currently?

目前，您的指南中包含了 8 月物質組成專利到期後的專利使用費假設是什麼？

And then secondly on Zolgensma, could you give us an update on the label expectations beyond the START and STR1VE populations that you were alluding to on the fourth quarter call?

其次，關於 Zolgensma，您能否向我們介紹一下您在第四季度電話會議上提到的 START 和 STR1VE 人群之外的標籤預期的最新情況？

And on the second death, your slide doesn't mention the neurological complications that were referred to in the media statements.

在第二次死亡時，您的幻燈片沒有提到媒體聲明中提到的神經系統並發症。

So could you elaborate on these, why you think the investigator determined that respiratory infection could possibly be treatment related and the expected timing of autopsy results and DSMB final determination on whether this was a drug-related death or not?

那麼，您能否詳細說明一下，為什麼您認為調查人員確定呼吸道感染可能與治療有關，屍檢結果的預期時間以及 DSMB 最終確定這是否與藥物有關的死亡？

Great.

偉大的。

So I'll actually start on the Zolgensma topic on the safety, and then I'll hand to the colleagues to take Gilenya and then also the Zolgensma labeling.

所以我實際上會從關於安全性的 Zolgensma 主題開始，然後我會交給同事服用 Gilenya，然後還有 Zolgensma 標籤。

So this is a situation where we had a disseminated sepsis.

所以在這種情況下，我們患上了播散性敗血症。

And in sepsis, you typically have neurological complications.

在敗血症中，您通常會出現神經系統並發症。

And so the neurological complications, to our estimation, related to the sepsis.

因此，據我們估計，神經系統並發症與敗血症有關。

I think the only question here is the administration of an AAV therapy in the context of an infection lead to an exacerbation of the infection.

我認為這裡唯一的問題是在感染導致感染惡化的情況下進行 AAV 治療。

In this case, I think we have advised all physicians going forward to ensure that there's appropriate steroid administration and ensure that all the supportive care is given.

在這種情況下，我認為我們已經建議所有醫生繼續前進，以確保有適當的類固醇給藥並確保提供所有支持性護理。

But I think that, one, the read across to the platform technology is not, in our view, appropriate.

但我認為，第一，在我們看來，跨平台技術閱讀並不合適。

I mean this is really about when you provide a therapy in the context of a very complex sepsis situation, you can exacerbate the overall care.

我的意思是，這實際上是關於當您在非常複雜的敗血症情況下提供治療時，您可能會加劇整體護理。

And so that's why the regulators were unconcerned.

這就是監管機構不關心的原因。

That's why the DSMB was unconcerned.

這就是 DSMB 不關心的原因。

We'll complete the autopsy results shortly and, of course, finalize the assessment.

我們很快就會完成屍檢結果，當然還會完成評估。

But I think the key thing to note is regulators, DSMB, clinical trials all on track, no change and no change for our expectations on timing of approval.

但我認為需要注意的關鍵是監管機構、DSMB、臨床試驗都在進行中，沒有變化，我們對批准時間的預期也沒有變化。

Now with respect to Gilenya, Mitsubishi, I'll give it to Paul.

現在關於 Gilenya、Mitsubishi，我會把它交給 Paul。

Paul?

保羅？

Yes.

是的。

Thank you, Graham, for the question.

謝謝格雷厄姆提出的問題。

So just remind everybody that our full year core operating income guidance reflects the current contractual terms with Mitsubishi, so no additional change there.

所以提醒大家，我們的全年核心營業收入指引反映了與三菱的當前合同條款，因此沒有其他變化。

And then John in -- or John or Paul in terms of the Zolgensma labeling.

然後約翰在 - 或約翰或保羅在 Zolgensma 標籤方面。

Yes.

是的。

In terms of Zolgensma labeling, Graham, as you know, we are studying this in a variety of SMA types, including Type 1, 2 and 3. And we have 4 studies ongoing.

在 Zolgensma 標記方面，格雷厄姆，如你所知，我們正在研究各種 SMA 類型，包括 1 型、2 型和 3 型。我們正在進行 4 項研究。

What I would say is that the discussions with the FDA and other regulatory agencies are going well.

我要說的是，與 FDA 和其他監管機構的討論進展順利。

And we're continuing to advance as we have these conversations.

隨著我們進行這些對話，我們將繼續前進。

And we can provide, of course, further updates once we see the final labeling from the FDA.

當然，一旦我們看到 FDA 的最終標籤，我們就可以提供進一步的更新。

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

你的下一個問題來自花旗銀行的 Andrew Baum。

Couple of questions.

幾個問題。

First for Vas, if I remember correctly, you gave upper end of a value-based reimbursement for Zolgensma at $5 million per patient.

首先是 Vas，如果我沒記錯的話，你以每位患者 500 萬美元的價格為 Zolgensma 提供了基於價值的報銷上限。

Does the data from the further follow-up of STR1VE still support that analysis?

STR1VE 進一步隨訪的數據是否仍然支持該分析？

And then the second question again to Vas.

然後第二個問題再次問 Vas。

Perhaps, you could talk us through how you see Novartis' role as a cell therapy player.

或許，您可以與我們談談您如何看待諾華公司作為細胞治療廠商的角色。

Arguably, the outlook is getting better from a U.S. perspective given the national coverage determination, greater tech-related add-on payment, but your pipeline seems to still focus only and very much on CD19.

可以說，鑑於國家覆蓋範圍的確定、與技術相關的附加支付的增加，從美國的角度來看，前景正在變得更好，但你的渠道似乎仍然只關注 CD19。

Should we expect additional business development for novel antibody constructs expanding into PCR as some of your competitors have done?

我們是否應該像您的一些競爭對手所做的那樣，期待將新型抗體構建擴展到 PCR 的額外業務發展？

Or are you following a different strategy for cell therapy here?

或者您在這裡採用不同的細胞療法策略？

Thank you, Andrew.

謝謝你，安德魯。

So first one in -- on Zolgensma, I think it's been well published through the various reports from ICER, out of $500,000 per quali cutoff, the medicine is cost-effective in the range of $4 million to $5 million.

所以第一個——在 Zolgensma 上，我認為它已經通過 ICER 的各種報告發表得很好，在每個 quali cutoff 500,000 美元中，這種藥物的成本效益在 400 萬到 500 萬美元之間。

And at $150,000 quali cutoff, it's cost effective at a range of $1.5 million.

以 150,000 美元的合格截止價計算，它的成本效益在 150 萬美元的範圍內。

And so that's the range that we're looking at.

這就是我們正在研究的範圍。

We don't believe any of the clinical data that we saw in the STR1VE study changes our assessment.

我們認為，我們在 STR1VE 研究中看到的任何臨床數據都不會改變我們的評估。

It's completely consistent with the overall performance we've seen.

這與我們看到的整體表現完全一致。

And I think, as ICER noted in their report, they recommend we should price lower than $4 million to $5 million based on their final report.

我認為，正如 ICER 在他們的報告中指出的那樣，根據他們的最終報告，他們建議我們的定價應該低於 400 萬到 500 萬美元。

We take that as useful information.

我們認為這是有用的信息。

And of course, we'll announce our final price in due course, but that hopefully gives you some of the boundaries.

當然，我們會在適當的時候公佈我們的最終價格，但希望這能給您一些限制。

Now in terms of cell therapies, we believe, fundamentally, along with AAV9 gene therapy and radioligand therapy, having the capability to do ex vivo cell therapy is going to be critical for our long-term ability to generate new medicines and continue to be a leader as a focused medicines company.

現在就細胞療法而言，我們相信，從根本上說，與 AAV9 基因療法和放射配體療法一起，能夠進行離體細胞療法對於我們產生新藥的長期能力至關重要，並繼續成為作為一家專注的醫藥公司的領導者。

That's why we started with CD19 CAR-T.

這就是我們開始使用 CD19 CAR-T 的原因。

Our initial focus in cancer will continue to be on B-cell therapies.

我們最初在癌症方面的重點將繼續放在 B 細胞療法上。

You saw we did an investment in a company called Poseida Therapeutics for an additional BCMA option.

你看到我們對一家名為 Poseida Therapeutics 的公司進行了投資，以獲得額外的 BCMA 選項。

We're continuing to build out our own portfolio internally of next generation as well as bispecific programs within the space of targeting B-cell cancers.

我們將繼續在下一代內部構建我們自己的產品組合，以及在靶向 B 細胞癌症領域的雙特異性項目。

So that's one thrust.

所以這是一個推動力。

Alongside that, we continue to look at using ex vivo cell therapies in a range of other condition, whether it's in next-generation technologies for hematology, looking at other therapeutic areas.

除此之外，我們繼續研究在一系列其他條件下使用離體細胞療法，無論是在下一代血液學技術中，還是在研究其他治療領域。

And that's part of the reason we built out the global manufacturing base that we have, with a manufacturing center now in the United States, 3 manufacturing centers in Europe, a manufacturing center in China and a manufacturing center in Japan as well as lentiviral production capability, both in-house and external, that we're building.

這就是我們建立全球製造基地的部分原因，我們現在有一個製造中心在美國，三個製造中心在歐洲，一個製造中心在中國，一個製造中心在日本，還有慢病毒生產能力，我們正在建設的內部和外部。

We believe then we would be the logical company to be able to scale ex vivo cell therapies across a range of indications.

我們相信，我們將成為能夠在一系列適應症中擴展離體細胞療法的合乎邏輯的公司。

So we'll continue to look externally, but we also, through both our internal pipeline, our alliance with Xencor, our alliance with CRISPR technologies -- CRISPR companies, we are also working on our internal portfolio as well.

因此，我們將繼續從外部尋找，但我們也通過我們的內部管道、我們與 Xencor 的聯盟、我們與 CRISPR 技術的聯盟——CRISPR 公司，我們也在致力於我們的內部產品組合。

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

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

Kind of a question across the pipeline, which is Slide 11, you described major launches planned through 2021.

整個流程中的一個問題，即幻燈片 11，您描述了計劃到 2021 年的主要發布。

And you showed 13 different medicines.

你展示了 13 種不同的藥物。

If we ignore the 3 already approved products, Cosentyx, Entresto and Mayzent, can you kind of pick out the top 3 that you think have the biggest sales potential, assuming that data comes out favorably?

如果我們忽略 3 種已經獲得批准的產品，Cosentyx、Entresto 和 Mayzent，假設數據結果良好，你能挑出你認為具有最大銷售潛力的前 3 種嗎？

You've got products like Zolgensma, RTH, fevipiprant, SAG101 and others.

你有 Zolgensma、RTH、fevipiprant、SAG101 等產品。

You have a very full pipeline, but it would help narrow down the focus for investors of what could matter most.

你有一個非常完整的渠道，但這將有助於縮小投資者關注最重要的事情的範圍。

And then RTH258, a quick question.

然後是 RTH258，一個簡短的問題。

Relative to last quarter's update, looks like the time line for filing DME and RVO each got pushed out by one year, and I'm wondering what drove that.

相對於上一季度的更新，提交 DME 和 RVO 的時間線似乎都被推遲了一年，我想知道是什麼推動了這一點。

So in terms of the -- thanks, Tim, for the questions.

所以就 - 謝謝蒂姆提出的問題。

On -- in terms of the 3 top, we're very excited, of course, Tim, by the whole range of products that we have.

關於 - 就前三名而言，蒂姆，我們當然對我們擁有的所有產品感到非常興奮。

But I'd say, of course, Zolgensma is absolutely critical and one, we believe, has significant potential across the range of SMA indications as a truly foundational therapy for SMA.

但我要說，當然，Zolgensma 絕對是至關重要的，我們相信，作為 SMA 的真正基礎療法，它在 SMA 適應症的範圍內具有巨大的潛力。

Clearly, RTH258 is something where we believe we can build our next-generation technology beyond Lucentis, also with the U.S. possibility to really drive significant potential for -- in this space.

顯然，RTH258 是我們相信我們可以在 Lucentis 之外構建下一代技術的東西，同時美國也有可能在這個領域真正推動巨大的潛力。

And then I think the big upside wild card we have is QAW039, where we could be the first oral medicine in a range -- large-type patient population, positioned before biologics in patients with severe asthma, who, if you look at the number of patients, who have already on triple inhaled therapy but still not adequately controlled, who are still not on a biologic.

然後我認為我們擁有的最大優勢是 QAW039，我們可以成為該範圍內的第一個口服藥物——大量患者群體，定位於嚴重哮喘患者的生物製劑之前，如果你看一下這個數字已經接受三重吸入治療但仍未充分控制且未接受生物製劑治療的患者。

I mean this is a very large patient population that we believe could be a major medicine if ultimately successful.

我的意思是，這是一個非常龐大的患者群體，我們相信如果最終成功，它可能成為一種主要藥物。

So those are 3. But again, I think all of them are quite exciting.

所以這些是 3。但是，我再次認為所有這些都非常令人興奮。

And then I would note, as well, we'll continue to provide more transparency and meet the management and other settings on the next wave of innovation we have with over 25 potential blockbusters in late-stage development.

然後我還要指出，我們將繼續提供更高的透明度，並在下一波創新浪潮中與管理層和其他環境會面，我們擁有超過 25 種處於後期開發中的潛在重磅炸彈。

Now in terms of RTH258, John?

現在就 RTH258 而言，約翰？

Yes.

是的。

So for brolucizumab, Tim, is -- the way that we capture these on time lines often is year by year.

因此，對於 brolucizumab，Tim 是——我們在時間線上捕獲這些的方式通常是逐年進行。

So what you see perhaps is a shift from 2019 to 2020 per se, but it's actually not a whole year in terms of delay.

所以你看到的可能是從 2019 年到 2020 年本身的轉變，但就延遲而言實際上並不是整整一年。

Often, these are quarters.

通常，這些是宿舍。

And in terms of the DMO study, there is just some discussions with the regulatory agency for us to be able to begin recruitment of that trial.

就 DMO 研究而言，我們只是與監管機構進行了一些討論，以便我們能夠開始招募該試驗。

So that was a slight delay of about one quarter.

所以這是一個大約四分之一的輕微延遲。

And also for the RBO study, it was a similar situation for us.

對於 RBO 研究，我們的情況也類似。

So really, these are not slippage in terms of one year, but just a quarter in terms of logistics.

所以真的，這些不是一年的延誤，而是物流方面的四分之一。

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

你的下一個問題來自 Crédit Suisse 的 Matthew Weston。

Two SMA questions, if I can, please.

如果可以的話，請問兩個 SMA 問題。

We've already had a question about price, and I fully understand that you're not going to comment.

我們已經提出了有關價格的問題，我完全理解您不會發表評論。

But one other thing that's very important for our models is when the income is actually going to come in for each patient.

但對我們的模型來說，另一件非常重要的事情是，收入何時真正會進入每位患者。

And I note with interest the comment that you've had a high interest in innovative contracting methods on your Slide 17.

我感興趣地註意到您在幻燈片 17 上對創新合同方法非常感興趣的評論。

So Vas, I'd be very interested if you could just set out, in broad brush strokes, what those innovative contracts could look like in terms of revenue recognition as a proportion of the total cost per patient in year 1 versus later subsequent payment.

所以 Vas，如果你能用粗略的筆觸列出這些創新合同在收入確認方面的情況，作為第 1 年每位患者總成本與以後後續付款的比例，我會非常感興趣。

And then secondly, I also note in clinical timelines in the press release your oral splice inhibitor, LMI, moved forward a couple of years in terms of filing to 2022.

其次，我還在新聞稿的臨床時間表中註意到你的口服剪接抑製劑 LMI 在申請方面提前了幾年到 2022 年。

Could you let us know what in terms of data has led you to bring that forward and such that you're now seeing it in a much more reasonable time frame?

您能否讓我們知道在數據方面是什麼導致您提出了這一點，並且您現在在更合理的時間範圍內看到了它？

Great.

偉大的。

Thanks, Matthew.

謝謝，馬修。

So Paul, why don't you start?

所以保羅，你為什麼不開始呢？

Yes.

是的。

So look, we've done a lot of research about pricing and we've really been listening very actively.

所以看，我們已經做了很多關於定價的研究，我們真的一直在非常積極地傾聽。

The vast majority, just to be clear, would prefer to pay upfront.

需要說明的是，絕大多數人更願意預先付款。

It's very much a budget allocation process and a phasing process so -- and we'll be prepared for that.

這在很大程度上是一個預算分配過程和一個分階段過程，所以我們會為此做好準備。

But there are a group of payers that prefer to pay over time and spread the cost.

但有一群付款人更願意分期付款並分攤成本。

And we'll allow that, I think, up to 5 years in terms of return.

我認為，就回報而言，我們將允許長達 5 年的時間。

As for revenue recognition, Harry?

至於收入確認，Harry？

Yes.

是的。

So Matthew, what we basically talked here about is the end of what is the pattern of the cash coming in, in case we would be collecting would be over a payment after 3, 4, 5 years.

所以馬修，我們在這里基本上談論的是現金收入模式的結束，以防我們在 3、4、5 年後收款。

So the cash may be delayed.

所以現金可能會延遲。

We could still choose about is there a financing company in between.

我們仍然可以選擇中間是否有一家融資公司。

We will see whatever is the MPV optimal way of doing that.

我們將看到 MPV 的最佳實現方式。

But in terms of sales recognition, I would expect as IFRS asked for sales -- revenue recognition, I'm virtually certain.

但就銷售確認而言，我希望 IFRS 要求銷售 - 收入確認，我幾乎可以肯定。

And we would probably book the majority of the sales once the respective conditions are fulfilled.

一旦滿足各自的條件，我們可能會預訂大部分銷售額。

And then in case the performance condition were reached based on the clinical trials and then read about evidence, we may have a small rebate that we book as we recognize the sales.

然後，如果根據臨床試驗達到性能條件，然後閱讀證據，我們可能會在確認銷售時預訂小額回扣。

So sales, I would expect to come quite quickly with the patients.

所以銷售，我希望患者能很快來。

And then on the cash side depends upon what revenue model we implement here.

然後在現金方面取決於我們在這裡實施的收入模式。

And then John, in terms of LMI.

然後是 John，就 LMI 而言。

In terms of LMI, as you know, Matthew, we believe that Zolgensma is the foundational therapy for patients with SMA.

就 LMI 而言，如你所知，Matthew，我們認為 Zolgensma 是 SMA 患者的基礎療法。

At the same time, given the severity of the disease, we also want to explore all opportunities for these babies to continue and improve.

同時，考慮到疾病的嚴重性，我們也想為這些寶寶探索一切繼續進步的機會。

We currently have a dose-ranging study that's ongoing for LMI, and that's continuing to move forward.

我們目前正在進行 LMI 的劑量範圍研究，並且該研究正在繼續推進。

Based on those results, I think we'll advance in terms of how we would register this product moving forward, and we'll have further understanding as we get these results.

基於這些結果，我認為我們將在如何註冊該產品方面取得進展，並且在獲得這些結果時我們將有進一步的了解。

And your next question comes from the line of Richard Parkes of Deutsche Bank.

你的下一個問題來自德意志銀行的理查德帕克斯。

I've got a couple of product questions as well.

我也有幾個產品問題。

Firstly, again, just on SMA, we're obviously looking forward to the data and on SMA Type 2 patients.

首先，再一次，就 SMA 而言，我們顯然期待數據和 SMA 2 型患者。

Obviously, there's a large prevalent patient pool there.

顯然，那裡有大量普遍存在的患者群體。

I'm just wondering how you think about penetrating that.

我只是想知道你如何看待穿透它。

I realize the AAV9 antibody exclusion is minimal for the infant population, but could help -- could you help us understand what proportion of Type 2, Type 3 patients might be eligible based on this and any other eligibility criteria and how much manufacturing capacity might be limiting to your ability to address that need?

我知道 AAV9 抗體排除對嬰兒人群來說是最小的，但可以幫助——你能幫助我們了解根據這個和任何其他資格標準，2 型和 3 型患者中有多少可能符合條件，以及可能有多少製造能力？限制您滿足該需求的能力？

So that's the first question.

這是第一個問題。

Second question is on siponimod.

第二個問題是關於siponimod。

Given the subsequent approval of MAVENCLAD with a label encompassing active SPMS, I'm wondering how you feel this impacts the drug's differentiation.

鑑於隨後批准了帶有包含活性 SPMS 標籤的 MAVENCLAD，我想知道您認為這會如何影響藥物的差異化。

And is there any risks that other highly active MS drugs could get labeled up if they specifically call out activity in that patient population?

如果其他高活性 MS 藥物特別指出該患者人群的活動，是否存在任何被標記的風險？

Turning to Paul, both for you.

轉向保羅，兩者都是為了你。

Yes.

是的。

Thanks, Richard, for the questions.

謝謝理查德提出的問題。

We're looking forward to AAN.

我們期待 AAN。

Just to remind everybody, there's a lot of data that will be shared at AAN.

提醒大家，AAN 將共享大量數據。

There's the -- more than the additional 12-month follow-up on START.

有 - 超過 START 的額外 12 個月跟進。

But with the additional 3 months' data on STR1VE, we'll have first presentation.

但是有了額外 3 個月的 STR1VE 數據，我們將進行首次展示。

Some of the data on SPR1NT.

SPR1NT上的一些數據。

And then of course, an early look at the strong data presentation of that.

然後當然，要儘早了解其強大的數據展示。

And I think that's where you're heading with the intrathecal formulation and the potential to go after, if you like, older patients.

而且我認為這就是您使用鞘內製劑的方向，如果您願意，也有可能追求老年患者。

There's just a couple of important things to realize.

只有幾件重要的事情需要意識到。

I think Vas made it upfront in this presentation about the neutralizing antibodies and the effect, whether a patient could be treated at all.

我認為 Vas 在本次演講中提前談到了中和抗體及其效果，即患者是否可以接受治療。

We see the large majority of patients suitable for treatment.

我們看到絕大多數患者適合治療。

Some of it will be weight based and some of it will be approached either IV or IT.

其中一些將基於重量，其中一些將通過 IV 或 IT 進行處理。

But we feel very confident that there is a large patient population that we will be eligible for.

但我們非常有信心，我們將有資格獲得大量患者。

A lot will depend on the label and where we net out but feeling very good about that.

很大程度上取決於標籤和我們在哪裡淨值，但對此感覺非常好。

And we'll have an investor call on May 8. I think that was mentioned.

我們將在 5 月 8 日召開投資者電話會議。我認為有人提到了這一點。

As for siponimod, again, Vas mentioned upfront, we're the only successfully studied medicine in secondary progressive MS, so that's quite a big deal.

至於 siponimod，Vas 前面提到過，我們是繼發性進展型 MS 中唯一成功研究的藥物，所以這很重要。

And whilst others may claim an overall ability to be indicated for active SPMS, it really is about being studied for it -- having the opportunity to meet a couple of opinion leaders last week very fresh after launch, who threw that point back at me.

雖然其他人可能聲稱具有主動 SPMS 指示的總體能力，但它確實是關於對其進行研究的——上周有機會在發布後非常新鮮地會見幾位意見領袖，他們將這一點反駁給我。

They're most interested in the drug with evidence in this patient population, not just getting the additional indication, but being proven in that patient population.

他們最感興趣的是在這個患者群體中有證據的藥物，不僅僅是獲得額外的適應症，而是在那個患者群體中得到證實。

I'd rather not comment on MAVENCLAD, but I think the label sort of will help you understand why we think siponimod is really the right option for the broader patient population.

我不想對 MAVENCLAD 發表評論，但我認為標籤會幫助您理解為什麼我們認為 siponimod 確實是更廣泛患者群體的正確選擇。

Thanks, Paul.

謝謝，保羅。

I think the other element to keep in mind is even with the presence of AAV antibodies, there has to be neutralizing against the AAV9 subtype to really preclude our ability to use the therapy.

我認為要記住的另一個因素是即使存在 AAV 抗體，也必須中和 AAV9 亞型才能真正排除我們使用該療法的能力。

That's the other thing to keep in mind as you look -- watch this space.

這是你看時要記住的另一件事——觀察這個空間。

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

你的下一個問題來自高盛的 Keyur Parekh。

Two questions, please, one on SME and the second on margins.

有兩個問題，一個關於 SME，第二個關於利潤。

First on SMA.

首先是 SMA。

Vas, I know there have been a couple of questions asked about

Vas，我知道有人問了幾個問題

(technical difficulty)

（技術難度）

Hello?

你好？

Go ahead, Keyur.

去吧，基爾。

Why don't you start again?

你為什麼不重新開始？

You had a question on SMA?

您對 SMA 有疑問？

Yes, and the second one, on margins.

是的，第二個，在利潤率上。

Just on SMA.

就在 SMA 上。

I know there have been a couple of questions asked about the kind of the breadth of the label.

我知道有人問了幾個關於標籤寬度的問題。

But can you share with us what ongoing data set the agency has had a preview to look at beyond Type 1?

但是您能否與我們分享該機構已經預覽過 Type 1 以外的哪些正在進行的數據集？

And how comfortable do you still feel about a broad label beyond Type 1?

您對第 1 類以外的廣泛標籤的感覺如何？

And secondly, on margins, very impressive kind of pharma margins this quarter.

其次，在利潤率方面，本季度的製藥利潤率非常可觀。

Can you tell us what you're doing differently?

你能告訴我們你在做什麼嗎？

And why this may not be sustainable as we think kind of beyond 2019?

為什麼這可能無法像我們認為的那樣持續到 2019 年之後？

Great.

偉大的。

Thanks, Keyur.

謝謝，基爾。

I think on SMA, as we noted earlier, we're in discussions with the agency regarding the final labeling and prefer not to comment on the breadth of the label as we're in the midst of those discussions.

我認為在 SMA 上，正如我們之前提到的，我們正在與該機構就最終標籤進行討論，並且在討論過程中不想對標籤的範圍發表評論。

But I think, as you know, in the START study, we had remarkable results.

但我認為，如您所知，在 START 研究中，我們取得了顯著的成果。

And I think in the STR1VE study as well, again very strong results.

而且我認為在 STR1VE 研究中也是如此，同樣是非常強大的結果。

And I think all of that is forming the basis of how well the FDA is ultimately looking at the therapy.

我認為所有這些都構成了 FDA 最終對這種療法進行審查的基礎。

In terms of the margins, I'm very pleased with our performance.

就利潤率而言，我對我們的表現非常滿意。

And I think there's, again, 2 key drivers for this.

而且我認為這有 2 個關鍵驅動因素。

One is the strong sales performance of our growth drivers, Cosentyx, Entresto, now are fully invested in, and so sales growth is falling to the bottom line.

一是我們的增長驅動因素 Cosentyx 和 Entresto 的強勁銷售業績，現在已全部投資，因此銷售增長正在下降至底線。

There's strong cost discipline in Innovative Medicines that the gross margin is falling through to the bottom.

創新藥物有很強的成本紀律，毛利率正在跌至谷底。

We see that also in oncology, where we see the upside performance in some of our key growth drivers.

我們在腫瘤學中也看到了這一點，我們在一些關鍵增長驅動因素中看到了上行表現。

Again, gross margin falling through.

再次，毛利率下降。

But I think also what you're seeing now is our renewed commitment and very clear commitment to productivity.

但我認為你現在看到的是我們對生產力的新承諾和非常明確的承諾。

We've stated multiple times we are serious now as a company about productivity both in Novartis Technical Operations and Novartis Business Services.

我們已經多次聲明，作為一家公司，我們現在非常重視諾華技術運營和諾華商業服務的生產力。

We had very strong COGS performance in Novartis Technical Operations, and we've really taken on an ambitious productivity program in that organization.

我們在 Novartis Technical Operations 的 COGS 表現非常出色，而且我們確實在該組織中實施了一項雄心勃勃的生產力計劃。

And similarly, in Novartis Business Services, again, we brought on, I think an outstanding leadership team with executives from outside the pharmaceuticals industry, who really now try to build a world-class business service organization that would be competitive with business service organizations in any industry.

同樣，在諾華商業服務部，我認為我們再次組建了一支優秀的領導團隊，其中包括來自製藥行業以外的高管，他們現在真正在努力建立一個世界級的商業服務組織，與美國的商業服務組織競爭任何行業。

That's the benchmark.

這就是基準。

And we're starting to see that productivity now start to also flow through the P&L.

我們開始看到生產力現在也開始通過損益表流動。

Now of course, we aspire to continue the momentum.

當然，現在我們渴望繼續保持這種勢頭。

But as Harry said, we need to, of course, be judicious when we think about some of the potential patent expiries and the competition we face, particularly in oncology with respect to Afinitor and Exjade.

但正如 Harry 所說，當我們考慮一些潛在的專利到期和我們面臨的競爭時，我們當然需要保持明智，特別是在 Afinitor 和 Exjade 方面的腫瘤學領域。

And I think we'll see how it goes.

我想我們會看到它的進展。

And of course, we want to, of course, outperform if we can, but we'll continue the momentum from here.

當然，如果可以的話，我們當然希望跑贏大盤，但我們會從這裡繼續保持這種勢頭。

Any other concerns?

還有其他顧慮嗎？

No.

不。

And your next question comes from the line of Richard Vosser of J.P. Morgan.

你的下一個問題來自摩根大通的 Richard Vosser。

First question.

第一個問題。

Just you mentioned on the established medicines business, Diovan and Exforge potentially having extra competitors.

剛才你提到了成熟的藥品業務，Diovan 和 Exforge 可能有更多的競爭對手。

Perhaps, you could talk more broadly about the sustainability and price pressure potential that you might see in China.

或許，您可以更廣泛地談談您可能在中國看到的可持續性和價格壓力潛力。

Obviously, volume potential going really well, but just thoughts on that sustainability.

顯然，銷量潛力非常好，但只是對可持續性的思考。

A little bit more detail there would be great.

再詳細一點就更好了。

And then second question, just on the oral solids business within Sandoz, just to pin down, give us a little bit of help with the continued business.

然後是第二個問題，關於 Sandoz 的口服固體業務，只是為了確定，為我們的持續業務提供一些幫助。

When exactly we should think about closing and when we should have that coming out as sales and profit for this year?

我們究竟應該在什麼時候考慮關閉以及我們應該在什麼時候將其作為今年的銷售額和利潤公佈？

Great.

偉大的。

So on China, Paul -- or on established medicines, Diovan, and then China.

所以關於中國，保羅 - 或者關於成熟的藥物，Diovan，然後是中國。

Yes.

是的。

So on the established medicines, we're really pleased with how it's come together, to be honest.

因此，老實說，對於成熟的藥物，我們真的很滿意它是如何組合在一起的。

And we've been much more efficient about how we supported the medicines, digital, other things, been a little bit leaner to reinvest in growth drivers, and that's been very sensible.

我們在支持藥物、數字和其他方面的效率更高了，對增長動力的再投資變得更加精簡，這是非常明智的。

And price pressures have been not unexpected and again well managed and predicted, so reasonable.

價格壓力並非出乎意料，而且也得到了很好的管理和預測，非常合理。

The real excitement actually is coming out of China and what we're doing and how we're putting the business together.

實際上，真正令人興奮的是來自中國以及我們正在做的事情以及我們如何將業務整合在一起。

Vas mentioned the potential for Entresto to be a significant medicine, already the best primary care launch of an oral medicine in the last 2 decades.

Vas 提到 Entresto 有可能成為一種重要的藥物，它已經是過去 20 年中最好的初級保健口服藥物。

We've got Lucentis growing at a significant rate.

我們讓 Lucentis 以顯著的速度增長。

We've got Cosentyx approval.

我們已經獲得了 Cosentyx 的批准。

We'll get reimbursed next year, Entresto reimbursed later this year.

我們明年會報銷，今年晚些時候 Entresto 會報銷。

The investments over the last 2 or 3 years are really starting to pay back.

過去 2 或 3 年的投資真正開始得到回報。

And we shared at meet the management (sic)[Meet Novartis Management] I think last year, the real one to watch for us in terms of the growing geography is going to be China, and we're really very well set.

我們在會見管理層（原文如此）[會見諾華管理層]時分享了我認為去年，就不斷增長的地理區域而言，真正值得我們關注的將是中國，我們確實做好了準備。

Even if there is some price pressure, our focus has been around volume and growing it even in Innovative Medicines, and we think we're set up very well to do that.

即使存在一些價格壓力，我們的重點一直放在銷量上，甚至在創新藥物領域也有所增長，我們認為我們已經做好了做到這一點的準備。

And maybe just to build on Paul's comments.

也許只是基於 Paul 的評論。

On China, broadly, we see 3 key trends.

在中國，從廣義上講，我們看到了 3 個主要趨勢。

The first key trend is there is the effort to tender the established medicines, which in the case of Diovan and Gleevec, of course, will lead to additional pressures.

第一個關鍵趨勢是努力對既定藥物進行招標，對於 Diovan 和 Gleevec 來說，這當然會帶來額外的壓力。

But that's going to free up $30 billion, we estimate, of money that can be reinvested in innovation.

但我們估計，這將釋放出 300 億美元的資金，這些資金可以重新投資於創新。

Combine that in a moment in time when the China FDA is becoming really world-leading in terms of its policies of allowing international studies to be done in China directly, more rapidly approving medicines.

結合這一時刻，中國食品藥品監督管理局在其允許國際研究直接在中國進行的政策方面真正處於世界領先地位，可以更快地批准藥品。

And then a more regular reimbursement environment, predictable reimbursement environment.

然後是更規律的報銷環境，可預測的報銷環境。

Our strategy in China is to pivot to new launches.

我們在中國的戰略是重心推出新產品。

And Paul and Susanne's organizations are very much focused on driving new launches to enable us to double our China business, we hope, over the coming 5 years.

Paul 和 Susanne 的組織非常專注於推動新品發布，我們希望在未來 5 年內使我們的中國業務翻一番。

And that's something we want to keep you updated on over the coming years.

這就是我們希望在未來幾年讓您了解最新情況。

Great.

偉大的。

Thanks, Richard -- or so on oral solids, sorry.

謝謝，理查德——關於口服固體，抱歉。

Harry?

哈利？

On oral solids, so the to be divested product portfolio to our vendor.

在口服固體方面，因此要將產品組合出售給我們的供應商。

So Richard, we continue to expect that divestment will be completed during 2019.

所以理查德，我們繼續預計撤資將在 2019 年完成。

Now it's, of course, pending closing conditions, including some regulatory approvals.

當然，現在是待定的成交條件，包括一些監管部門的批准。

We are not in control of that because our vendor is leading this.

我們無法控制這一點，因為我們的供應商正在領導這一點。

And from a forecast assumption, that will continue to take quarter 3. But of course, we cannot be certain about that, but I think that's a good forecast assumption.

從預測假設來看，這將持續到第 3 季度。當然，我們不能確定這一點，但我認為這是一個很好的預測假設。

And what we also will do once the divestment is completed, we would provide then pro forma financials for the continuing operations, which would exclude that to be divested business for '18 and '19.

一旦剝離完成，我們還將做的是，我們將為持續經營提供備考財務數據，這將不包括 18 年和 19 年剝離的業務。

So it's easier for everybody to model.

所以每個人都更容易建模。

Your next question comes from the line of Florent Cespedes of Societe Generale.

你的下一個問題來自法國興業銀行的 Florent Cespedes。

Two non-SMA related questions.

兩個非 SMA 相關的問題。

First for Susanne on the Kisqali.

首先是 Kisqali 上的 Susanne。

The performance this quarter seems to be a bit better.

本季度的表現似乎要好一些。

So could you please elaborate on that, if you a kind of trend or any reason to explain this?

那麼，如果您有某種趨勢或任何理由來解釋這一點，您能否詳細說明一下？

And my second question is for Paul on Tasigna.

我的第二個問題是關於 Tasigna 的 Paul。

The sales performance on the other -- on this product this quarter is a bit softer.

另一方面——本季度該產品的銷售業績略微疲軟。

It's a mature product, but could you elaborate a bit or give any reason for that?

這是一個成熟的產品，但你能詳細說明一下或給出任何理由嗎？

Do you see a trend behind that?

你看到這背後的趨勢了嗎？

Thanks, Florent.

謝謝，弗洛倫特。

So both Kisqali and Tasigna, Susanne?

Kisqali 和 Tasigna，Susanne？

Thank you.

謝謝。

Thank you, Florent, for the question.

謝謝 Florent 提出的問題。

So Kisqali, we had a very good quarter, very pleased.

所以 Kisqali，我們有一個非常好的季度，非常高興。

We said it could reach $91 million and we really see gaining momentum.

我們說它可能達到 9100 萬美元，而且我們確實看到了增長勢頭。

And that is driven mostly by the expansion of indications into premenopausal settings and into the combination with fulvestrant.

這主要是由於適應症擴展到絕經前環境和與氟維司群的組合。

And that makes us the CDK 4/6 as the broadest data set in first line.

這使我們的 CDK 4/6 成為一線最廣泛的數據集。

So outside U.S., we see very strong growth driven by further penetration.

因此，在美國以外，我們看到進一步滲透推動了非常強勁的增長。

But also in the U.S., we see very good momentum the last week.

但同樣在美國，我們看到上週的勢頭非常好。

So as we always said, Kisqali remains a very important growth driver for Novartis Oncology, and we are confident that this product has the potential to reach blockbuster status.

因此，正如我們一直所說的那樣，Kisqali 仍然是諾華腫瘤學非常重要的增長動力，我們相信該產品有潛力達到重磅炸彈的地位。

Regarding Tasigna, so Tasigna had a few soft months.

關於塔西尼亞，所以塔西尼亞軟軟了幾個月。

And I think as we also said last quarter, we have a very focused action plan to differentiate Tasigna in terms of efficacy and broader and deeper response, and we are confident that we can return to modest growth by the second half of the year.

而且我認為正如我們上個季度也說過的那樣，我們有一個非常有針對性的行動計劃來區分 Tasigna 在療效和更廣泛和更深入的反應方面，我們有信心我們可以在今年下半年恢復適度增長。

Your next question comes from the line of Paul Welford (sic)[Peter Welford] of Jefferies.

你的下一個問題來自 Jefferies 的 Paul Welford (sic)[Peter Welford]。

It's Peter Welford, Jefferies.

我是 Jefferies 的 Peter Welford。

Two questions, please.

請教兩個問題。

Firstly on the Sandoz business.

首先是 Sandoz 業務。

I noticed that the Biopharmaceuticals sales has been perhaps a little weak this quarter.

我注意到本季度生物製藥的銷售額可能有點疲軟。

Any sort of insight on the growth trajectory for those and whether or not we should anticipate an uptick during the course of the year?

對這些增長軌蹟有何見解，以及我們是否應該預計今年會出現增長？

And perhaps comment there on what you're seeing in the underlying markets there.

也許在那裡評論你在基礎市場中看到的情況。

And then secondly, on Lutathera.

其次，關於 Lutathera。

Possible to give us the U.S. sales perhaps this quarter, all the ex U.S. split?

可能會在本季度向我們提供美國銷售額，所有美國除外？

And also any commentary on the types of patients you're typically treating, if you get NET patients?

如果您有 NET 患者，還有關於您通常治療的患者類型的評論嗎？

Or are you seeing update -- uptake, sorry, in a broad range of NET patients?

或者您是否看到更新——對不起，在廣泛的 NET 患者中？

Thanks for the question.

謝謝你的問題。

On Sandoz Biopharmaceuticals, globally, we saw very strong growth really driven by Europe.

在 Sandoz Biopharmaceuticals，在全球範圍內，我們看到真正由歐洲推動的非常強勁的增長。

And Europe is performing well with the recent launches of Rixathon, our rituximab biosimilar; and Erelzi, our etanercept biosimilar.

歐洲最近推出了我們的利妥昔單抗生物仿製藥 Rixathon，表現良好；和 Erelzi，我們的依那西普生物類似藥。

And we're also now preparing for what we hope is an approval of our pegfilgrastim biosimilar relatively soon to build on what I think is arguably the broadest portfolio of biosimilars in the market.

我們現在也在準備我們希望我們的 pegfilgrastim 生物仿製藥相對較快獲得批准，以建立在我認為可以說是市場上最廣泛的生物仿製藥組合的基礎上。

Any softness we've seen in the U.S., where we've had seen additional competition both on Glatopa, our Copaxone generic, as well as on Filgrastim, where we have additional entrants coming into that product line.

我們在美國看到的任何疲軟，我們在 Glatopa 上看到了更多的競爭，我們的 Copaxone 仿製藥，以及 Filgrastim，我們有更多的進入者進入該產品線。

Key for us in the United States will be continued launches.

我們在美國的關鍵將是繼續發射。

So we are on track now with pegfilgrastim, and I think that will enable us hopefully to have a potential approval depending on how FDA finds the resubmitted data.

所以我們現在正在使用 pegfilgrastim，我認為這將使我們有希望獲得潛在的批准，具體取決於 FDA 如何找到重新提交的數據。

That's a 6-month clock from our resubmission as it was a CRL.

這是我們重新提交後 6 個月的時間，因為它是 CRL。

As well as, of course, we have the outstanding situation with Erelzi in the United States as well as then upcoming future filings and launches.

當然，我們還有 Erelzi 在美國的出色情況以及即將到來的未來申請和發布。

I think now the key for us in the U.S. will be to replenish the biosimilars portfolio.

我認為現在我們在美國的關鍵是補充生物仿製藥產品組合。

And with respect to, Lutathera, Susanne?

關於 Lutathera，Susanne？

Vas, as you highlighted, we were very pleased with the performance, Lutathera reaching more than $100 million.

Vas，正如您強調的那樣，我們對 Lutathera 的表現非常滿意，達到了超過 1 億美元。

And to your question on where it's come from, it's the vast majority coming from the U.S., where we really see great momentum.

關於它來自哪裡的問題，絕大多數來自美國，我們確實看到了巨大的勢頭。

We have now more than 125 centers using the treatment, treating more than 2,000 patients.

我們現在有超過 125 個中心使用這種療法，治療了 2,000 多名患者。

And what we also see now, first, it's coming from Europe.

我們現在也看到，首先，它來自歐洲。

So vast majority coming from the U.S. and some sales coming from Europe.

所以絕大多數來自美國，一些銷售來自歐洲。

Then you asked about patients.

然後你問了病人。

So it's neuroendocrine tumors, and it's mostly second-line patients that see some progress.

所以是神經內分泌腫瘤，看到一些進展的多是二線患者。

So as you remember, the results from meta study really showed tremendous, tremendous impact on progression-free survival and overall survival in this setting.

因此，正如您所記得的那樣，薈萃研究的結果確實顯示了這種情況下對無進展生存期和總體生存期的巨大影響。

And this is where the majority of the patients come from.

這就是大多數患者的來源。

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

你的下一個問題來自古根海姆的 Seamus Fernandez。

So I was hoping that we could talk a little bit about incremental margins and a couple of opportunities.

所以我希望我們能談談增量利潤和一些機會。

First off, the incremental margins that we can sort of think about reading into the underlying core P&L for Zolgensma despite obviously cash flows dynamics from some of the payer agreements notwithstanding.

首先，儘管某些支付協議存在明顯的現金流動態，但我們可以考慮將增量利潤率讀入 Zolgensma 的基礎核心損益表。

But just hoping to better understand the kind of incremental margins and the contribution that this can make to the margins going forward.

但只是希望更好地了解增量利潤率的類型以及這對未來利潤率的貢獻。

As well with Zolgensma, can you just help us understand the challenges that the company might face for patients who are already on drugs like Spinraza and how that -- how you will deal with that within the context of the payer environment?

與 Zolgensma 一樣，您能否幫助我們了解公司可能為已經服用 Spiraza 等藥物的患者面臨的挑戰，以及您將如何在付款人環境中應對這些挑戰？

And then the second question is on RTH.

然後第二個問題是關於 RTH 的。

Again, incremental margins There.

同樣，增量利潤率在那裡。

I think I recall, Vas, you talked about some challenges with manufacturing with RTH and getting that to kind of consistent pharmaceutical margins for an antibody product.

我想我記得，Vas，你談到了使用 RTH 製造的一些挑戰，並使抗體產品的製藥利潤率保持一致。

Can you just update us on that?

你能告訴我們最新情況嗎？

And it seems like there's also a heavy royalty burden that we should be thinking about with Lucentis relative to that, that certainly RTH could be a positive contributor there.

與此相關的 Lucentis 似乎還存在沉重的版稅負擔，RTH 肯定會在那裡做出積極的貢獻。

So first on margins with respect to Zolgensma, thanks, Seamus, for the questions.

所以首先是關於 Zolgensma 的邊距，謝謝 Seamus 提出的問題。

Harry?

哈利？

Yes.

是的。

I would say actually, we can almost take them a bit together because these are in the end different price levels; yes, different populations.

我想說實際上，我們幾乎可以把它們放在一起，因為它們最終是不同的價格水平；是的，不同的人群。

But in terms of costs of goods and royalty burden and so on, a quite higher-margin product.

但從商品成本和特許權使用費負擔等方面來看，是一款利潤率相當高的產品。

There's some royalties on Zolgensma, but very focused, as you can imagine, marketing and sales effort.

Zolgensma 有一些版稅，但正如您可以想像的那樣，非常專注於營銷和銷售工作。

So very high margins expected on Zolgensma.

Zolgensma 的利潤率非常高。

Same goes true for RTH with a slightly different mix.

RTH 也是如此，但混音略有不同。

Of course, there's a bit more margin in sales.

當然，銷售利潤率要高一些。

But even when you look at Lucentis like footprint, it's quite focused and specialty and focused center market.

但即使當你像足跡一樣看待 Lucentis 時，它也是非常專注、專業和專注的中心市場。

So both of these products, I would expect to significantly contribution after launch period to our margin, not only to sales, but margin, profits and cash flows.

因此，我希望這兩種產品在推出後對我們的利潤率做出重大貢獻，不僅是銷售額，還有利潤率、利潤和現金流。

Paul, on Zolgensma switching?

保羅，關於 Zolgensma 轉換？

So we are aware that it's going to be one of those things that is being discussed.

所以我們知道這將是正在討論的事情之一。

And it will be very much to the payers to decide how they handle that.

付款人將決定他們如何處理。

But from our perspective, and we've worked through the [MAT] program to try and make sure that it is an option for patients.

但從我們的角度來看，我們已經通過 [MAT] 計劃努力確保它是患者的一種選擇。

So it will be very much case by case, but I think we will -- we're very open to allowing it to happen.

所以這將視具體情況而定，但我認為我們會——我們非常願意允許它發生。

So then lastly, on RTH manufacturing.

最後，關於 RTH 製造。

One of the things I want to clarify is our filing now involves the updated manufacturing process.

我想澄清的一件事是我們的備案現在涉及更新的製造過程。

You'll recall we had a delay in RTH because we needed to update the manufacturing process.

你會記得我們在 RTH 上有一個延遲，因為我們需要更新製造過程。

We completed that.

我們完成了。

We completed the bridging studies.

我們完成了橋接研究。

So the margins with respect -- or the cost of goods with respect to RTH now are competitive with what we'd expect from any of our biologic products.

因此，與 RTH 相關的利潤率或商品成本現在與我們對任何生物產品的期望相比具有競爭力。

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

你的下一個問題來自摩根士丹利的 Mark Purcell。

Mark Purcell from Morgan Stanley.

摩根士丹利的馬克·珀塞爾。

A couple of follow-ups on Zolgensma.

Zolgensma 的一些後續行動。

And then just firstly on Sandostatin LAR.

然後首先使用 Sandostatin LAR。

You said you're keeping an eye on the generics situation there.

你說你正在關注那裡的仿製藥情況。

So can you help us understand the developments you're watching and what we should expect in terms of competitive dynamics going forward?

那麼，您能否幫助我們了解您正在觀察的發展以及我們在未來競爭動態方面應該期待什麼？

And then going back to Zolgensma.

然後回到 Zolgensma。

Some really encouraging prelaunch prep that you've described very clearly on Slide 17.

您在幻燈片 17 上非常清楚地描述了一些非常令人鼓舞的啟動前準備工作。

In relation to previous studies, in terms of combination, so are you going to do any combination trials yourselves in patients who are also going to be treated with Spinraza?

關於之前的研究，就組合而言，您是否打算自己對也將接受 Spiraza 治療的患者進行任何組合試驗？

And in terms of patients who already received Spinraza -- or already received Zolgensma and then have followed up with a Spinraza therapy on top, can you help us understand the reasons why these children are using both drugs together as opposed to just Zolgensma as a single therapy?

就已經接受過 Spinraza 或已經接受 Zolgensma 然後在頂部進行 Spinraza 治療的患者而言，你能幫助我們理解為什麼這些孩子同時使用這兩種藥物而不是單獨使用 Zolgensma 的原因嗎治療？

And then there was an earlier question on manufacturing.

然後還有一個關於製造的早期問題。

Can you help us understand the current manufacturing footprint, the capacity you have in terms of treatment patient numbers in terms of the IV?

您能否幫助我們了解當前的製造足跡，您在 IV 方面的治療患者數量方面的能力？

And as you move to intrathecal, how that sort of addressable patient population is going to change?

當您轉向鞘內註射時，可尋址的患者群體將如何變化？

And if we should expect any potential changes in terms of safety and efficacy given you're moving from a systemic IV product to something that may have less systemic exposure?

考慮到您正在從全身 IV 產品轉向全身暴露較少的產品，我們是否應該期待在安全性和有效性方面有任何潛在變化？

Thank you, Mark, for the questions.

馬克，謝謝你提出的問題。

So first on the Sandostatin LAR, Susanne?

那麼首先是關於 Sandostatin LAR，Susanne？

So on Sandostatin LAR, the situation has not changed, but as Harry mentioned, we are monitoring closely.

所以在 Sandostatin LAR 上，情況沒有改變，但正如 Harry 提到的，我們正在密切關注。

The situation is that we're aware of one company that has initiated regulatory procedures in Europe, and we assume the same to be the case in the U.S., but no change at the moment, but we are monitoring closely.

情況是，我們知道一家公司已在歐洲啟動監管程序，我們假設美國也是如此，但目前沒有變化，但我們正在密切關注。

So in respect to Zolgensma combination trials, manufacturing capacity, et cetera, Paul?

那麼關於 Zolgensma 組合試驗、製造能力等，保羅？

So on the combination trials, I think we've mentioned this before, but it's probably worth repeating.

所以在組合試驗中，我想我們之前已經提到過這一點，但它可能值得重複。

Where there was evidence of patients getting both, it's where patients have gone into the study, desperately ill children into a study with Zolgensma.

在有證據表明患者同時獲得這兩種藥物的地方，就是患者進入研究的地方，患絕症的兒童進入了 Zolgensma 的研究。

And of course, the parents wanted to give whatever they could on top.

當然，父母想盡其所能。

And I think that's understandable because it was still an investigational compound at that point.

我認為這是可以理解的，因為當時它仍然是一種研究化合物。

I think now the question, the whole conversation has moved very separately to how do we move patients from Spinraza to Zolgensma?

我認為現在的問題是，整個對話已經非常獨立地轉移到我們如何將患者從 Spiraza 轉移到 Zolgensma ？

And we're collecting the data to do that and showing it where we can.

我們正在收集數據來做到這一點，並儘可能地展示它。

So we feel confident that we'll be able to help physicians and payers understand that as we go.

因此，我們有信心在我們前進的過程中能夠幫助醫生和付款人理解這一點。

There is also, by the way, an appetite from payers to make that switch.

順便說一句，付款人也有進行這種轉變的意願。

So we'll see where we get to.

所以我們會看到我們到達哪裡。

In terms of manufacturing, a general manufacturing update, Vas mentioned the 1 million square feet.

在製造方面，一般製造更新，Vas 提到了 100 萬平方英尺。

We were already set up before we took on the Colorado facility to match what we think will be the demand over the next year or so.

在我們接手科羅拉多工廠之前，我們已經建立起來，以滿足我們認為未來一年左右的需求。

We took the opportunity to take on a high-tech facility, a biologics GMP-approved facility to make sure that as we go further into the prevalent population, if there's an unprecedented level in the 2s and 3s, we can cover that, too.

我們藉此機會建立了一個高科技設施，一個生物製劑 GMP 批准的設施，以確保隨著我們進一步深入到流行人群中，如果 2s 和 3s 達到前所未有的水平，我們也可以覆蓋它。

So we have more than enough capacity to deal with what we think could be an unprecedented demand.

因此，我們有足夠的能力來應對我們認為可能是前所未有的需求。

Thank you, Paul.

謝謝你，保羅。

And thanks, Mark, for the question.

馬克，謝謝你提出這個問題。

I'd maybe also want to highlight that again, we'll present additional long-term follow-up data from the START study, but we are seeing continued sustained efficacy in the patients that we've described to you the past.

我可能還想再次強調這一點，我們將提供來自 START 研究的更多長期隨訪數據，但我們在過去向您描述的患者中看到了持續的持續療效。

And any patient who chooses to add on a therapy, as Paul said, it's purely out of the patient's decision -- or parents' decision, not because of anything with respect to Zolgensma in our view.

正如保羅所說，任何選擇增加治療的患者，這純粹是患者的決定——或父母的決定，而不是因為我們認為與 Zolgensma 相關的任何事情。

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

你的下一個問題來自 Cowen 的 Steve Scala。

First, on the psoriasis market, is there anything you would like to highlight in the risankizumab label or price that represents a competitive advantage for Cosentyx?

首先，在銀屑病市場上，您是否希望在 risankizumab 標籤或價格中突出顯示 Cosentyx 的競爭優勢？

And Vas, when you were speaking about the ARROW trial, you mentioned rapid onset.

Vas，當你談到 ARROW 試驗時，你提到了快速起效。

Is that likely to be the sole point of differentiation versus the IL-23s in psoriasis?

這可能是銀屑病與 IL-23 的唯一區別點嗎？

And then secondly, on the Gilenya royalty question, to clarify, what is now assumed in the revised operating income guidance?

其次，關於 Gilenya 特許權使用費問題，澄清一下，修訂後的營業收入指南現在假設了什麼？

Is a lower royalty to Mitsubishi assumed, so operating income guidance might have to come down if the lower royalty doesn't happen?

是否假定三菱的特許權使用費較低，因此如果特許權使用費較低，營業收入指引可能不得不下調？

Or is the current royalty assumed so operating income guidance might have to move higher if the lower royalty is realized?

還是假定當前的特許權使用費，因此如果實現較低的特許權使用費，營業收入指導可能必須提高？

So first off, so thanks, Steve for the questions on psoriasis, risankizumab and the ARROW study.

首先，非常感謝史蒂夫提出有關牛皮癬、risankizumab 和 ARROW 研究的問題。

Paul?

保羅？

So another IL-23 entered the market.

於是另一種IL-23進入了市場。

We feel that we are -- that the market is well served with the medicines it has already.

我們覺得我們是——市場已經得到了很好的藥物服務。

We think that a skin-only approach is part of it.

我們認為僅皮膚方法是其中的一部分。

You've seen from the data Vas showed on NBRx.

您已經從 Vas 在 NBRx 上顯示的數據中看到了。

Although NBRx is volatile, it does show you what position we've taken as one of the leading, if not of the leading, new medicine in the psoriasis space.

儘管 NBRx 不穩定，但它確實向您展示了我們在牛皮癬領域作為領先（如果不是領先）新藥之一的地位。

Our growth in psoriasis is above-market continuously.

我們在牛皮癬方面的增長持續高於市場。

So we don't think there's anything clinically to be gained from risankizumab entering the market at all, but we do expect AbbVie and their heritage and their presence in the market and what that could mean.

因此，我們認為 risankizumab 進入市場根本不會在臨床上獲得任何好處，但我們確實期待 AbbVie 及其傳統及其在市場上的存在以及這可能意味著什麼。

We think that more than skin is needed to be treated.

我們認為需要治療的不僅僅是皮膚。

And we've seen from TREMFYA we know how to handle an IL-23 in general terms.

我們從 TREMFYA 中了解到，我們知道如何一般地處理 IL-23。

In terms of Gilenya, do you want me to...

就 Gilenya 而言，你想讓我...

It was the ARROW study.

這是 ARROW 研究。

I'm sorry, the ARROW study.

對不起，ARROW 研究。

We said when we took the study on, we wanted to advance the understanding -- the mechanistic understanding for the community.

我們說，當我們進行這項研究時，我們希望增進理解——對社區的機械理解。

We think there is a lot more to psoriasis, and we think that's why the IL-17 mechanism is going to be absolutely critical.

我們認為銀屑病還有很多其他原因，我們認為這就是為什麼 IL-17 機制將變得絕對關鍵。

And I think we'll get the readout towards the end of the year from recollection, and we're looking forward to adding that and helping with the debate.

而且我認為我們會在今年年底從回憶中得到讀數，我們期待著添加它並幫助進行辯論。

You've seen from our performance and our growth in quarter 1 versus quarter 1 last year, we're in a very good place and we've taken some very sensible decisions on where we feel that our NBRx growth is showing, that we've made some good choices.

從我們第一季度與去年第一季度相比的業績和增長來看，我們處於一個非常好的位置，我們已經做出了一些非常明智的決定，決定我們認為我們的 NBRx 增長在哪裡，我們'我們做了一些不錯的選擇。

And before I move to Gilenya, maybe just a few other quick points on Cosentyx.

在我搬到 Gilenya 之前，也許只是 Cosentyx 的其他一些快速要點。

I mean, I think the key we need to keep reminding colleagues on the phone is that IL-17A, we've demonstrated through the data we have on all of the additional manifestations of psoriasis, whether it's palmoplantar, whether it's nail, whether it's scalp, that IL-17A seems to be really a preferred therapy from the data we've generated to date in treating these hard-to-treat psoriasis patients.

我的意思是，我認為我們需要在電話中不斷提醒同事的關鍵是 IL-17A，我們已經通過我們擁有的關於牛皮癬所有其他表現的數據證明了這一點，無論是掌蹠、指甲還是頭皮，從我們迄今為止在治療這些難以治療的牛皮癬患者中獲得的數據來看，IL-17A 似乎確實是一種首選療法。

In addition, we know that the IL-12/23 has not been successful to date in ankylosing spondylitis, particularly with respect to some of the elements in the joint.

此外，我們知道 IL-12/23 迄今為止在強直性脊柱炎方面尚未取得成功，特別是在關節中的某些元素方面。

So again, IL-17A proves itself to be really a differentiating medicine in ankylosing spondylitis, and then we also believe in psoriatic arthritis, particularly with respect to enthesitis, which is the inflammation of some of the insertion points in the joints.

因此，IL-17A 再次證明自己確實是強直性脊柱炎的鑑別藥物，然後我們也相信銀屑病關節炎，特別是附著點炎，這是關節中某些插入點的炎症。

So there are multiple points of differentiation that go beyond speed of onset, which we also think we've demonstrated as well.

因此，除了發病速度之外，還有多個差異點，我們也認為我們也已經證明了這一點。

Now with respect to the Gilenya royalty, Harry?

現在關於 Gilenya 皇室成員，Harry？

We cannot really add much to what Paul has said here.

對於保羅在這裡所說的話，我們真的不能再多說什麼了。

So we reflect the current contractual terms.

因此，我們反映了當前的合同條款。

And I would not expect the guidance to change one or the other direction anyway.

而且我不希望指南改變一個或另一個方向。

So we just -- that's what we can say and unfortunately not more.

所以我們只是——這就是我們可以說的，不幸的是，我們不能說更多。

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

您的下一個問題來自 Redburn 的 Simon Baker。

Two, please.

兩個，請。

Firstly, I wonder if you could give us an update on the expected timing and potential remedies in your litigation with Amgen with respect to the Aimovig co-promotion.

首先，我想知道您是否可以向我們提供有關 Aimovig 聯合促銷與 Amgen 訴訟的預期時間和潛在補救措施的最新信息。

And secondly, now that you've completed the dividend in kind distribution of Alcon to Novartis shareholders, I was wondering if in principle, the same can be done with the Roche shareholding that you have.

其次，既然你已經完成了愛爾康向諾華股東的實物股息分配，我想知道原則上，你擁有的羅氏股權是否也可以這樣做。

Yes.

是的。

So first on the Amgen case, I'll hand it over to Paul.

所以首先關於安進案，我會把它交給保羅。

So just 1 sentence or 2 before I get to the case itself.

因此，在我進入案例本身之前，只需一兩句話。

We're delighted with the progress we're making with Aimovig, and we're thrilled with what we're doing for patients.

我們對 Aimovig 取得的進展感到高興，我們對為患者所做的事情感到興奮。

It's a huge unmet need, and we don't blink.

這是一個巨大的未滿足需求，我們不會眨眼。

That is business as usual for us.

這對我們來說一切照舊。

And we go on to get reimbursement and approvals across Europe and the rest of the world.

我們繼續在歐洲和世界其他地區獲得報銷和批准。

As for the legal dispute, well, we're very confident in the strength of our legal position.

至於法律糾紛，嗯，我們對我們的法律地位非常有信心。

One thing you may be interested to hear is that we -- in fact, the U.S. agreement does not even contain the clause on which Amgen relies as a basis for its termination, so we feel very good about where we're positioned.

你可能有興趣聽到的一件事是我們 - 事實上，美國協議甚至不包含安進作為其終止基礎的條款，所以我們對我們的定位感到非常滿意。

But above all, and this happens between big companies occasionally, but above all, it's business as usual with migraine and migraine patients and Aimovig.

但最重要的是，這種情況偶爾會發生在大公司之間，但最重要的是，偏頭痛和偏頭痛患者以及 Aimovig 的業務照常進行。

And with respect to the Roche, there's no change in our position.

關於羅氏，我們的立場沒有改變。

It continues to be a financial state with a strategic component.

它仍然是一個具有戰略組成部分的金融國家。

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

你的下一個問題來自瑞銀集團的 Laura Sutcliffe。

Two questions, please.

請教兩個問題。

One on Zolgensma and then a follow-up on margin.

一個關於 Zolgensma，然後是一個關於保證金的後續行動。

On Zolgensma, if I read the slides from your conference presentation last week correctly, there were noticeably more adverse events in STR1VE than there were in your earlier study.

在 Zolgensma 上，如果我上周正確閱讀了你們會議演講中的幻燈片，那麼 STR1VE 中的不良事件明顯多於你們之前的研究。

As far as I understand, the product that was used in STR1VE was commercially produced, whereas the one for the earlier study was not.

據我了解，STR1VE 中使用的產品是商業生產的，而早期研究中使用的產品則不是。

Is that a potential source of the difference?

這是差異的潛在來源嗎？

And if not, where do you think it could come from?

如果不是，您認為它可能來自哪裡？

And secondly, on margins.

其次，利潤率。

Could you just outline some of the pushes and pulls you expect on your gross margin in Innovative Medicines specifically throughout the rest of 2019?

您能否概述一下您預計在 2019 年剩餘時間內對創新藥物毛利率的一些推動和拉動？

Yes.

是的。

On the first question, on Zolgensma, I'll hand it to Paul.

關於第一個問題，關於 Zolgensma，我會把它交給 Paul。

Paul?

保羅？

So yes, an interesting question.

所以是的，一個有趣的問題。

I mean we don't see any difference, in fact, and we performed extensive analytical and clinical comparability studies.

我的意思是我們沒有看到任何差異，事實上，我們進行了廣泛的分析和臨床可比性研究。

So we think any difference at all is in the baseline characteristics of the patients.

所以我們認為任何差異都在於患者的基線特徵。

So let's also be clear.

因此，讓我們也明確一點。

The improvement made by the children is significant on CHOP INTEND, et cetera.

孩子們所做的改進在 CHOP INTEND 等方面具有重要意義。

So we feel very good about the results and look forward to sharing more and across more studies at AAN.

因此，我們對結果感到非常滿意，並期待在 AAN 分享更多和更多的研究。

Yes.

是的。

So I think we don't see the safety difference that I assume our competitors are [feeding] . So on the margins?

所以我認為我們沒有看到我認為我們的競爭對手正在 [feeding] 的安全差異。所以在邊緣？

Yes.

是的。

The gross margins pushes and pulls.

毛利率推動和拉動。

I mean, of course, we have on the one hand always mix.

我的意思是，當然，一方面我們總是混合在一起。

It's very important.

這很重要。

As you know, some of our products are -- most of our products are quite high-margin products, so high gross margins.

如您所知，我們的一些產品 - 我們的大部分產品都是利潤率很高的產品，因此毛利率很高。

A few are lower.

有幾個較低。

On the other hand, we see that the key growth drivers have quite high margin.

另一方面，我們看到主要的增長動力具有相當高的利潤率。

So Afinitor, Exjade and the tail end of Gleevec, of course, are also very high margin.

所以Afinitor、Exjade和尾端的Gleevec，當然利潤率也非常高。

So I would say from that standpoint, the mix probably neutralizes as we expect a bit more generic impact in the future quarters.

所以我想說，從這個角度來看，這種組合可能會中和，因為我們預計未來幾個季度會產生更普遍的影響。

And then we have the whole technical operations transformation plan.

然後我們有了整個技術運營轉型計劃。

That already has contributed, but we expect that to continue.

這已經有所貢獻，但我們希望這種情況會繼續下去。

So a bit hard to completely predict, but I would say that we have made good gross margin improvements, and we don't -- and if you take everything together, we probably expect roughly the same gross margin year-over-year.

所以有點難以完全預測，但我想說我們已經取得了很好的毛利率改善，但我們沒有——如果你把所有的東西放在一起，我們可能預計毛利率與去年同期大致相同。

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

您的下一個問題來自 Exane 的 Kerry Holford。

Two questions please for me.

請問我兩個問題。

Firstly, on Entresto.

首先，關於 Entresto。

I wonder if you can just comment on the U.S. growth in the quarter with [rates low].

我想知道你是否可以用 [低利率] 評論本季度美國的增長。

How sustainable is that going forward when you talk about the underlying volume demand versus price contribution in the quarter with this destocking in Q1?

當您談論第一季度的這種去庫存時本季度的潛在數量需求與價格貢獻時，這種情況的可持續性如何？

And also, I wonder whether this drug also has been a beneficiary of the generics supply shortage in the U.S. Secondly, on MS. `Can you quantify (inaudible) was destocking for Gilenya in Q1?

而且，我想知道這種藥物是否也是美國仿製藥供應短缺的受益者。其次，關於 MS。 `你能量化（聽不清）第一季度 Gilenya 的去庫存嗎？

Can you quantify that?

你能量化嗎？

And also talk about the underlying demand for that product and talk about the relative positioning of Mayzent versus Gilenya.

還要談談對該產品的潛在需求，並談談 Mayzent 與 Gilenya 的相對定位。

Are you yet at a position where you're talking about negotiations' access, needing to -- of high rebates on Gilenya perhaps in exchange for access in Mayzent?

您是否還處於談論談判准入的位置，需要——對 Gilenya 的高額回扣可能以換取 Mayzent 的准入？

So Paul, both for you, Entresto and then Gilenya and Mayzent.

所以 Paul，為你，Entresto，然後是 Gilenya 和 Mayzent。

It sounded a bit more like 2 more -- more than 2 questions, but I'm going to give some fast answers.

聽起來更像是 2 個以上的問題 - 超過 2 個問題，但我會快速給出一些答案。

Entresto's performance has been fantastic.

Entresto 的表現非常出色。

We're now starting to see the fruits of all the effort we put in.

我們現在開始看到我們付出的所有努力的成果。

We saw the PIONEER data kick on.

我們看到了 PIONEER 數據的啟動。

And so we've seen the hospital initiation data set complete, so feeling good about that.

因此，我們已經看到完整的醫院啟動數據集，對此感覺很好。

Will it continue?

它會繼續嗎？

We believe it does continue, and we believe that PARAGON readout is going to be the next sort of accelerator if the results are good.

我們相信它會繼續下去，我們相信如果結果好的話，PARAGON readout 將成為下一種加速器。

But we know confidence is high and we know that Entresto becoming standard of care in many settings is really an important position for us.

但我們知道信心很高，我們知道 Entresto 在許多情況下成為護理標準對我們來說確實是一個重要的位置。

For Gilenya, the comments around -- there is definitely some destocking, and there was, of course, as I mentioned, in Q1 last year, there was some stocking.

對於 Gilenya，周圍的評論——肯定有一些去庫存，當然，正如我提到的，在去年第一季度，有一些庫存。

So the like-for-like comparison would have been very close to consensus, I think, without the inventory moves.

因此，我認為，如果沒有庫存變動，同類比較將非常接近共識。

Underlying demand is solid, frankly, so no issue there.

坦率地說，潛在需求是穩固的，所以沒有問題。

As for Mayzent, 50% to 80% of patients progress.

至於 Mayzent，50% 到 80% 的患者會取得進展。

And I refer to some opinion leaders I spoke to last week.

我指的是上週與我交談過的一些意見領袖。

They know that, and they've now had an opportunity to have a specifically proven medicine in that group.

他們知道這一點，並且他們現在有機會在該小組中獲得經過特別驗證的藥物。

They look at Mayzent's position as taking all-comers who are progressing, not specifically Gilenya.

他們認為 Mayzent 的立場是接受正在進步的所有人，而不是特定的 Gilenya。

So we'll continue as we do -- as we go on to identify this patient population, but we feel confident as we begin to educate and communicate that we'll be in a very good place with Mayzent right across all medicines for the switch potential.

所以我們將繼續我們所做的——當我們繼續確定這個患者群體時，但當我們開始教育和溝通時，我們感到自信，我們將在所有藥物中與 Mayzent 處於一個非常好的位置，以進行轉換潛在的。

Your next question comes from the line of Emmanuel Papadakis of Barclays.

你的下一個問題來自巴克萊銀行的 Emmanuel Papadakis。

Maybe one for Harry on buybacks.

也許是哈利回購的一個。

You reiterated several times you're going to complete $5 billion by the end of this calendar year.

你多次重申你將在本日曆年年底前完成 50 億美元。

You are very light in Q1.

你在Q1很輕。

Is there any particular reason why you've left that phasing heavily skewed through the remainder of the year?

在今年餘下的時間裡，您是否有任何特別的原因導致該階段嚴重偏斜？

And is there particular things we should think about for modeling perspective in terms of the phases of distribution over the remainder of this year?

在今年剩餘時間的分配階段方面，我們是否應該考慮建模角度的特定事項？

Second, a couple of quick follow-ups.

其次，一些快速跟進。

Kymriah, you've referenced in the report discussions with the FDA aiming to change the specifications in the U.S. If you could just elaborate on that.

Kymriah，你在報告中提到與 FDA 的討論旨在改變美國的規格，如果你能詳細說明一下。

I think it's fair to say you're continuing to lag your key competitor in that space.

我認為可以公平地說，您在該領域繼續落後於您的主要競爭對手。

So any color in terms of how that may change and when, would be helpful.

因此，關於可能如何變化以及何時變化的任何顏色都會有所幫助。

And then just a quick follow-up BYL.

然後只是快速跟進 BYL。

You alluded to 80% payer coverage.

你提到了 80% 的付款人覆蓋率。

I assumed that was for the drug itself.

我以為那是藥物本身。

Just a bit more color in terms of the diagnostic payment, test cost coverage, et cetera, would also be very helpful.

在診斷費用、測試費用範圍等方面再多一點顏色，也會非常有幫助。

So first, Harry on buybacks.

所以首先，哈利回購。

Yes, thank you.

是的，謝謝。

So on the share buyback, I mean as you can imagine, level of share price is one key input into that activity.

因此，在股票回購方面，我的意思是正如你所想像的那樣，股價水平是該活動的一個關鍵輸入。

And we also were quite optimistic that the Alcon spin would happen in April.

我們也非常樂觀地認為愛爾康將在 4 月份進行分拆。

So I think the timing of the majority of the share buyback after the Alcon spin is probably a good one.

因此，我認為愛爾康分拆後回購大部分股票的時機可能是個好時機。

And that's why as of tomorrow.

這就是為什麼從明天開始。

We will already start again, and restart that share buyback program, and we are quite optimistic that we will finish it by the end of the year.

我們已經重新開始，並重啟股票回購計劃，我們非常樂觀地認為我們將在今年年底前完成。

Yes.

是的。

We want to maximize the number of shares we can of course take that out of circulation for the benefit of Novartis shareholders.

我們希望最大限度地增加我們當然可以為了諾華股東的利益而將其退出流通的股票數量。

Susanne, both on Kymriah and BYL.

Susanne，在 Kymriah 和 BYL 上。

Yes.

是的。

Thank you for the questions.

謝謝你的問題。

On Kymriah, I think when you look over the last 6 months, we made quite good progress in terms of building our manufacturing footprint.

在 Kymriah 上，我認為當你回顧過去 6 個月時，我們在建立製造足跡方面取得了相當大的進步。

We recently got FDA approval to increase manufacturing capacity.

我們最近獲得了 FDA 的批准，可以提高生產能力。

We got in addition approval from health authorities outside the U.S., namely EU, Switzerland, Australia, Japan and Canada, to widen the commercial specification in line with the clinical product.

我們還獲得了美國以外的衛生當局（即歐盟、瑞士、澳大利亞、日本和加拿大）的批准，以擴大與臨床產品一致的商業規格。

FDA has not yet approved our prior approval supplement application, citing insufficient information to widen Kymriah's commercial specification.

FDA 尚未批准我們的事先批准補充申請，理由是沒有足夠的信息來擴大 Kymriah 的商業規格。

So we are obviously disappointed by this decision, and we are working closely with FDA to find a way forward.

因此，我們顯然對這一決定感到失望，我們正在與 FDA 密切合作以尋找前進的道路。

We also plan to collect additional data, and we'll update you as soon as we have more clarity.

我們還計劃收集更多數據，我們會在更清楚的情況下盡快通知您。

On the BYL diagnostic?

在 BYL 診斷上？

Yes.

是的。

in terms of BYL, as Vas mentioned, we're quite excited about the launch, and we plan to launch together with a companion diagnostic provided by Qiagen.

就 BYL 而言，正如 Vas 所提到的，我們對此次發布感到非常興奮，我們計劃與 Qiagen 提供的配套診斷一起發布。

And we work very closely with Qiagen to allow broad coverage and also reimbursement for the tests.

我們與 Qiagen 密切合作，以實現廣泛的覆蓋範圍和報銷測試。

Your next question comes from the line of Marietta Miemietz of Primavenue.

您的下一個問題來自 Primavenue 的 Marietta Miemietz。

A couple of financial questions, please, for Harry first.

請先問哈利幾個財務問題。

You hinted at a guidance upgrade if the pipeline delivers according to plan.

如果管道按計劃交付，您暗示會升級指南。

So could you just share with us some of the major news flow items that have been excluded from the current guidance?

那麼，您能否與我們分享一些已被排除在當前指南之外的主要新聞流項目？

And also, could you please quantify any dis-synergies from the Alcon spin-off that could weigh on margins from Q2 onwards and for how long they are expected to persist?

此外，您能否量化愛爾康分拆帶來的任何協同效應，這些協同效應可能會從第二季度開始影響利潤率，以及它們預計會持續多久？

And then a couple of product questions, please.

請再問幾個產品問題。

Coming back to Kymriah in the U.S., just trying to get a little bit more detail there.

回到美國的 Kymriah，只是想在那裡了解更多細節。

Is the situation that the FDA has simply not yet made up its mind, whether the specs can be changed at all?

FDA 根本還沒有決定是否可以更改規格的情況？

Or have they sort of indicated that they're willing to meet you halfway, but you're still working to show that you can get the number of viable cells up to the proposed new threshold?

或者他們是否表示他們願意在中途與您會面，但您仍在努力證明您可以使活細胞數量達到建議的新閾值？

And can you maybe just also elaborate a little bit on the current impact on your U.S. business in terms of sales, in terms of taking on new commercial patients, what your capacity is and if clinical trials are continuing as planned?

你能不能也詳細說明一下目前對你的美國業務的影響，在銷售方面，在接受新的商業患者方面，你的能力是什麼，以及臨床試驗是否按計劃進行？

And then finally, sorry to come back to the Zolgensma safety issue.

最後，很抱歉回到 Zolgensma 安全問題。

But I mean, I was quite surprised actually by the panic that was sparked by that second death.

但我的意思是，我對第二次死亡引發的恐慌感到非常驚訝。

Because I would assume that also the respiratory issues can actually arise as a complication of the disease itself.

因為我認為呼吸系統問題實際上也可能作為疾病本身的並發症出現。

So it would just be really, really helpful if you could help us understand in very general terms any potential mechanism by which Zolgensma could theoretically even contribute to respiratory infections and how that can be ruled out in an autopsy?

因此，如果您能幫助我們以非常籠統的方式理解 Zolgensma 理論上什至可能導致呼吸道感染的任何潛在機制，以及如何在屍檢中排除這種機制，那將真的非常有幫助？

Is this really all about sort of that tiny risk of the vector recombining with other viruses?

這真的只是關於載體與其他病毒重組的那種微小風險嗎？

And do you actually have any data in patients or in vitro, whatever, to see whether and how that actually happens?

你是否真的有任何關於患者或體外的數據，以了解這是否以及如何發生？

So any color there would be very helpful.

所以那裡的任何顏色都會非常有幫助。

Thanks, Marietta.

謝謝，瑪麗埃塔。

So I'll take the first -- the third question first.

所以我先回答第一個——第三個問題。

With respect to Zolgensma, no, there's no mechanistic reason, and this is primarily a situation where when you give an AAV therapy, you do trigger and enhance stimulation of the immune system.

關於 Zolgensma，不，沒有機械原因，這主要是一種情況，當你進行 AAV 治療時，你確實觸發並增強了免疫系統的刺激。

If you do in the context of sepsis, you can, of course, exacerbate potentially the sepsis.

如果你在敗血症的背景下這樣做，你當然可能會加劇敗血症。

There is no preclusion criteria for an infection because we want to maximize the number of children treated.

沒有感染的排除標準，因為我們希望最大限度地增加接受治療的兒童人數。

So this is a situation where we administer to therapy.

所以這是我們進行治療的情況。

I think the key is you need to give steroids at an appropriate time with respect to when AAV is administered.

我認為關鍵是你需要在適當的時間給予類固醇，以考慮何時給予 AAV。

That's the absolute key in terms of managing a situation like this, where a patient has multiple potential infectious agents already affecting them, and we want to minimize the impact that AAV might have on the clinical course of the patient.

這是管理這種情況的絕對關鍵，在這種情況下，患者已經有多種潛在的傳染原在影響他們，我們希望盡量減少 AAV 可能對患者臨床過程的影響。

Again, I would say this is not a platform question.

同樣，我會說這不是平台問題。

This is more about when you give a therapy like this in the context of a very potent immune response to an existing infection, you can, of course, have consequences to that, which would be the case for any medicine that you give in this setting.

這更多的是關於當你在對現有感染產生非常強大的免疫反應的情況下給予這樣的治療時，你當然可以對此產生影響，這對於你在這種情況下給予的任何藥物都是如此.

So with respect to...

所以相對於...

Just to follow up on that, how can you actually then rule out on the autopsy that the medicine contributed anything?

只是為了跟進，你怎麼能在屍檢中排除藥物有任何作用呢？

Because you can never know whether it was a too strong immune response that killed the patient and whether the drug contributed at all.

因為你永遠無法知道是否是一種過於強烈的免疫反應殺死了病人，也不知道藥物是否起到了作用。

So I'm just a little bit confused how...

所以我只是有點困惑如何......

The good news is we have regulators who make these decisions.

好消息是我們有監管機構來做出這些決定。

Fortunately, we have independent DSMBs and regulators who have all already said there's no necessary changes to the trial protocol, no changes to the clinical program and no changes to the overall approval timeline.

幸運的是，我們有獨立的 DSMB 和監管機構，他們都已經表示沒有對試驗方案進行必要的更改，沒有對臨床計劃進行更改，也沒有對總體批准時間表進行更改。

So I think I leave it in the hands of the very capable independent organizations that make these assessments.

因此，我認為我將其交給進行這些評估的非常有能力的獨立組織。

I will, of course, provide the data with respect to the autopsy to the relevant agency.

我當然會把屍檢的資料提供給有關部門。

And we look forward to completing the regulatory timelines towards an approval.

我們期待完成監管時間表以獲得批准。

Now with respect to the guidance upgrade, Harry?

現在關於指導升級，Harry？

Yes.

是的。

So as you have seen, we had a very strong quarter 1. 7% sales growth.

因此，正如您所見，我們第 1 季度的銷售額增長非常強勁，增長了 7%。

Innovative Medicines, 10% sales growth.

創新藥物，銷售額增長 10%。

Core operating income growth would come to 18%.

核心營業收入增長將達到 18%。

And with that, of course, you have to see okay, how is rest of the year going?

因此，當然，你必須看看好吧，今年剩下的時間過得怎麼樣？

Such a strong start.

如此強大的開始。

Some people even mentioned maybe there should be more upgrades.

有些人甚至提到也許應該有更多的升級。

Anyway, I think strong start.

無論如何，我認為強大的開始。

On the other hand, we should never get ahead of ourselves.

另一方面，我們永遠不應該超越自己。

Clearly, on the bottom line, we see the potential for the upgrades that we have given.

顯然，在底線，我們看到了我們提供的升級的潛力。

In terms of some of the pushes and pulls, clearly, we have to see what are the labels we get.

就一些推拉而言，很明顯，我們必須看看我們得到的標籤是什麼。

Some are very important medicines, that where we expect approvals over the next quarters.

有些是非常重要的藥物，我們預計將在接下來的幾個季度獲得批准。

That's on the one hand.

這是一方面。

On the other hand, we have to see also how fast is there a generic erosion on Afinitor and Exjade, for example, or Exforge in Europe, a smaller product, and if is there anything on Sandostatin LAR.

另一方面，我們還必須了解 Afinitor 和 Exjade 等通用侵蝕的速度有多快，或者歐洲的 Exforge 是一種較小的產品，以及 Sandostatin LAR 是否存在任何問題。

So those are some of the pushes and pulls.

所以這些是一些推動和拉動。

We just cast them already.

我們已經投了他們。

So I think we have given a good, prudent guidance.

所以我認為我們已經給出了一個很好的、審慎的指導。

On the other hand, this is also a quarter where we expect to have the least generic exposure.

另一方面，這也是我們預計通用風險最低的一個季度。

So I think we are well set with this.

所以我認為我們已經做好了準備。

And then we'll see how quarter 2 evolves and quarter 3, and then I think we are in a very good situation to give an updated guidance if necessary.

然後我們將看到第 2 季度和第 3 季度的發展情況，然後我認為我們處於非常好的情況，可以在必要時提供更新的指導。

On the interest of time, I think we're going to have to go to the last 2 questions on the line.

為了節省時間，我認為我們將不得不轉到在線的最後兩個問題。

We'll get back to you, Marietta, on your other questions.

瑪麗埃塔，我們會就你的其他問題回复你。

Your next question comes from the line of Vincent Chen of Bernstein.

你的下一個問題來自伯恩斯坦的 Vincent Chen。

I was wondering if you could just help us quickly dimensionalize what types of data we should expect to see at AAN, for the Zolgensma intrathecal STRONG study specifically.

我想知道您是否可以幫助我們快速確定我們應該期望在 AAN 上看到的數據類型，特別是針對 Zolgensma 鞘內 STRONG 研究。

Should we expect to see data on achievement of motor milestones?

我們是否應該期望看到有關運動里程碑成就的數據？

Or is it more reasonable to expect that the focus will be on initial data on patient trajectory on motor function scale than safety given the relatively early stage of the study?

或者，鑑於研究處於相對較早的階段，預計重點將放在運動功能量表上患者軌蹟的初始數據上而不是安全性上是否更合理？

So Paul, on the AAN data readouts?

那麼保羅，關於 AAN 數據讀數？

So you said upfront what you expect to see.

所以你預先說了你期望看到的。

I told you a little bit earlier, I think START [will need] another year, STR1VE an additional 3 months of data, SPRINT plus presentation of the data in the recent somatic population.

我之前告訴過你，我認為 START [將需要] 再過一年，STR1VE 額外 3 個月的數據，SPRINT 加上最近體細胞群中數據的呈現。

The STRONG, which you mentioned, again, you will see some reflection on dosing.

你再次提到的 STRONG，你會看到一些關於劑量的反思。

It will have some feedback on dosing in the low to mid dose.

它將對中低劑量的給藥有一些反饋。

And I think we'll see some feedback on scanning and support for greater than 2 seconds [along the end point], so you'll start to see the benefit and see some of the evidence of that in the type 2.

而且我認為我們會看到一些關於掃描和支持超過 2 秒 [沿終點] 的反饋，因此您將開始看到好處並在類型 2 中看到一些證據。

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

你的下一個問題來自花旗銀行的 Andrew Baum。

Just a follow-up in relation to RTH, please.

請就 RTH 進行跟進。

The conversations we have with ophthalmologists is a concern about taking up fridge storage space given the limitation of only having an initial approval for AMD.

我們與眼科醫生的談話是關於佔用冰箱存儲空間的擔憂，因為只有初步批准 AMD 的限制。

Conversely, continuing with Lucentis or Eylea, that has obviously multiple approvals.

相反，繼續使用 Lucentis 或 Eylea，這顯然有多個批准。

To what extent do you think that's going to limit the adoption until you actually have that [GME] in hand?

在您實際擁有 [GME] 之前，您認為這會在多大程度上限制採用？

And then very quickly if I could, on rebate reform, do you anticipate it will be enforced for January the 1st of next year?

然後很快，如果可以的話，關於退稅改革，你預計它會在明年 1 月 1 日實施嗎？

And do you want to comment on the impact you think it will have on realized pricing for those products affected within your portfolio?

您是否想評論您認為這將對您的投資組合中受影響的那些產品的實際定價產生的影響？

Great.

偉大的。

Thanks, Andrew.

謝謝，安德魯。

So on RTH, Paul?

那麼在 RTH 上，保羅？

Of course, yes, fridge storage space is something to consider.

當然，是的，冰箱存儲空間是需要考慮的因素。

You may be interested to know it's part of world-class preparation.

您可能有興趣了解它是世界級準備工作的一部分。

We spent a lot of time looking at specifically at this and observing workflow to try and make sure we know.

我們花了很多時間專門研究這個並觀察工作流程以嘗試確保我們知道。

We think having a Q 12 without any sacrifice in visual acuity, that's what we hope for in our label, and that is we think worthy of fridge space and so much more.

我們認為 Q 12 不會犧牲任何視覺敏銳度，這就是我們在標籤中所希望的，而且我們認為值得冰箱空間等等。

Yes, the other indications require the medicine.

是的，其他適應症需要藥物。

Most retina specialists have 1-plus, so we believe that we will have earned our right for the right amount of shelf space, if you like.

大多數視網膜專家都有 1+，因此我們相信，如果您願意，我們將贏得適當數量的貨架空間的權利。

And for everybody that we've spoken to, they feel strongly that our interval and our fluid resolution is compelling enough to demand capacity in their own office environment.

對於與我們交談過的每個人來說，他們強烈認為我們的間隔和我們的流動分辨率足以吸引他們自己辦公環境的容量。

I'll go back to rebate reform.

我會回去進行回扣改革。

It's difficult to judge the exact timing of the administration's proposal to be implemented.

很難判斷政府提議實施的確切時間。

We support, along with many of our industry peers, the removal of rebates in Medicare Part D. We believe this will achieve the goal of reducing patient out-of-pocket at the pharmacy counter.

我們與我們的許多同行一起支持取消 Medicare D 部分的回扣。我們相信這將實現減少患者在藥房櫃檯自付費用的目標。

It's difficult for us to judge the exact impact until we know the details of how this will all transpire, but we certainly would expect given our overall portfolio, as relatively low exposure to the U.S. payer environment -- government payer environment, not significant effects on our overall portfolio.

在我們知道這一切將如何發生的細節之前，我們很難判斷確切的影響，但我們肯定會期望鑑於我們的整體投資組合，因為美國付款人環境 - 政府付款人環境的風險敞口相對較低，不會對我們的整體產品組合。

I think we have one more question from Tim Anderson.

我想我們還有蒂姆·安德森 (Tim Anderson) 提出的另一個問題。

So Tim, please go ahead.

蒂姆，請繼續。

Tim, your line is open.

蒂姆，你的線路是開放的。

Please go ahead.

請繼續。

No?

不？

Okay.

好的。

So we may have lost him.

所以我們可能已經失去他了。

Okay.

好的。

Thank you very much.

非常感謝。

So with that, thanks again for your interest in the company.

因此，再次感謝您對公司的興趣。

A strong Q1.

強勁的 Q1。

We're looking forward to continue to deliver momentum over the course of the year, and we'll continue to keep you updated as we progress.

我們期待在這一年中繼續保持勢頭，我們將繼續為您提供最新進展。

Thanks for joining the call.

感謝您加入電話會議。

Thank you, ladies and gentlemen.

謝謝你們，女士們，先生們。

That does complete your conference for today.

這確實完成了您今天的會議。

Thank you for participating, and you may now disconnect.

感謝您的參與，您現在可以斷開連接。