Novartis AG (NVS) 2017 Q1 法說會逐字稿

Good morning, and good afternoon, and welcome to the Novartis Q1 2017 Results Release Conference Call and Live Audio Webcast.

早上好，下午好，歡迎來到諾華 2017 年第一季度業績發布電話會議和現場音頻網絡廣播。

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

（操作員說明）電話會議的錄音將在電話會議結束後不久在我們的網站上提供。

(Operator Instructions) With that, I would like to hand over to Mr. Joe Jimenez, CEO of Novartis.

（操作員說明）有了這個，我想交給諾華公司首席執行官 Joe Jimenez 先生。

Please go ahead, sir.

請繼續，先生。

Thank you, and I'd like to welcome everybody to our first quarter earnings call.

謝謝大家，歡迎大家參加我們的第一季度財報電話會議。

Joining me here on the Novartis end are Harry Kirsch, our CFO; Vas Narasimhan, our Head of Global Drug Development; and we have the 4 business leaders Paul Hudson, Head of Pharma; Bruno Strigini, Head of Oncology; Richard Francis, Head of Sandoz; and Mike Ball, Head of Alcon.

和我一起來到諾華公司的是我們的首席財務官 Harry Kirsch；我們的全球藥物開發主管 Vas Narasimhan；我們有 4 位商業領袖 Paul Hudson，製藥主管； Bruno Strigini，腫瘤學負責人； Sandoz 負責人 Richard Francis；和愛爾康的負責人 Mike Ball。

So before we start, I'd like Samir to read the safe harbor statement.

因此，在我們開始之前，我希望 Samir 閱讀安全港聲明。

Samir?

薩米爾？

Thank you, Joe.

謝謝你，喬。

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。

Thanks, Samir.

謝謝，薩米爾。

Okay, starting on slide number four, Novartis had a solid first quarter.

好的，從第四張幻燈片開始，諾華公司第一季度表現穩定。

Our sales were up 2% in constant currencies as Cosentyx and Entresto offset the Gleevec patent expiration.

我們的銷售額按固定匯率計算增長了 2%，因為 Cosentyx 和 Entresto 抵消了 Gleevec 專利到期的影響。

Our core operating income was down 5% due to investments that we've made behind the new product launches, as well as the Gleevec patent loss.

由於我們在新產品發布後進行的投資以及 Gleevec 專利損失，我們的核心營業收入下降了 5%。

And our innovation momentum continues, especially in Oncology, which we'll talk about in a minute.

我們的創新勢頭仍在繼續，尤其是在腫瘤學領域，我們稍後會談到這一點。

On Slide five, all the divisions contributed to our net sales growth in the first quarter.

在幻燈片 5 中，所有部門都為我們第一季度的淨銷售額增長做出了貢獻。

So Innovative Medicines, up 2%.

因此，創新藥物上漲了 2%。

This was driven by the pharma BU, which rose 6% behind Entresto and Cosentyx.

這是由製藥業務推動的，該業務增長了 6%，落後於 Entresto 和 Cosentyx。

Sandoz was up 1%, driven by Biopharmaceuticals, which grew 30%, this is mainly due to Zarxio and Glatopa 20 milligram in the U.S. And Alcon grew 1% driven by the Vision Care side of the business, which was up 4 points.

Sandoz 增長 1%，受生物製藥增長 30% 的推動，這主要是由於美國的 Zarxio 和 Glatopa 20 毫克，Alcon 增長 1%，受視力保健業務增長 4 個百分點的推動。

On Slide six, we made good progress on innovation in the first quarter.

在幻燈片六中，我們在第一季度的創新方面取得了良好進展。

Vas is going to go through some of these programs in detail, but I did want to call out CTL019, in particular, because this is our first filing in immuno-oncology.

Vas 將詳細介紹其中一些項目，但我確實想特別提到 CTL019，因為這是我們在免疫腫瘤學領域的第一份申請。

We filed in pediatric ALL in the U.S, with a priority review, and we also received breakthrough therapy designation in DLBCL, which we plan to file later this year in the U.S. This is significant because I think people questioned our commitment to this program, when we integrated the cell therapy unit back into Oncology, but you can see that we're committed to this and we think we can make this a big business for us.

我們在美國提交了兒科 ALL 申請，並進行了優先審查，我們還獲得了 DLBCL 的突破性治療指定，我們計劃今年晚些時候在美國提交申請。這很重要，因為我認為人們質疑我們對該計劃的承諾，當我們將細胞治療部門重新整合到腫瘤學中，但你可以看到我們致力於此，我們認為我們可以使它成為我們的一項大業務。

Now with all the good news, I do have to bring up the 2 setbacks we had in the quarter.

現在有了所有好消息，我必須提出我們在本季度遇到的 2 個挫折。

One was serelaxin, the Phase III study, as you know, did not meet its primary endpoint.

一個是 serelaxin，如您所知，III 期研究沒有達到其主要終點。

And also, Glatopa 40-milligram launch was delayed due to a warning letter on a third party manufacturing site.

此外，Glatopa 40 毫克的發射由於第三方製造站點的警告信而被推遲。

But clearly, there's good momentum overall in the pipeline.

但顯然，總體上勢頭良好。

On Slide seven, I wanted to point out that we are aggressively strengthening our internal pipeline with early-stage acquisitions in in-licensing, and I think the market hasn't quite really recognized the degree to which we are strengthening.

在幻燈片 7 中，我想指出，我們正在通過早期收購許可來積極加強我們的內部管道，我認為市場還沒有真正認識到我們加強的程度。

I think we talked about this in the fourth quarter, as you can see on the slide, the 4 that we brought in, but we're continuing that activity in 2017.

我想我們在第四季度討論過這個問題，正如你在幻燈片上看到的那樣，我們帶來了第四季度，但我們將在 2017 年繼續這項活動。

So we expanded our development program in NASH, as you heard a couple of weeks ago, with our collaboration with Allergan.

因此，正如您幾週前聽到的那樣，我們通過與 Allergan 的合作，擴大了 NASH 的開發計劃。

And also, we added U.S. co-commercialization rights just yesterday, with Amgen on AMG 334 in migraine.

而且，我們昨天剛剛增加了美國的共同商業化權利，與安進（Amgen）在偏頭痛的 AMG 334 上。

So on the next slide, turning to commercial execution, we drove the key launches well in the first quarter.

因此，在下一張幻燈片上，轉向商業執行，我們在第一季度推動了關鍵的發布。

Entresto is progressing nicely, sales of $84 million in the first quarter.

Entresto 進展順利，第一季度銷售額為 8400 萬美元。

2/3 of these sales are coming from the U.S. and you can see that we're starting to see a bit of acceleration in new-to-brand scripts.

這些銷售額中有 2/3 來自美國，您可以看到我們開始看到新品牌腳本的加速增長。

We were getting about 1,800 per week at the end of the fourth quarter.

到第四季度末，我們每週收到大約 1,800 個。

We're now at over 2,000 and we expect this to continue to translate to increasing total scripts as we move throughout the year.

我們現在有 2,000 多個，我們希望隨著我們全年的移動，這將繼續轉化為增加的腳本總數。

On Slide nine, you can see that Entresto is now approved in 78 countries around the world.

在幻燈片九中，您可以看到 Entresto 現在已在全球 78 個國家/地區獲得批准。

And we're continuing to make progress with pricing and reimbursement.

我們將繼續在定價和報銷方面取得進展。

Specifically, we had reimbursed launches in Italy, in Canada in the first quarter; we also secured our final reimbursement price in Germany, with a good price that reflects the real value of this medicine.

具體來說，我們在第一季度在意大利和加拿大進行了報銷；我們還在德國獲得了最終報銷價格，該價格反映了該藥物的實際價值。

So we expect this progress to continue and it's going to contribute to growth throughout the year.

因此，我們預計這一進展將繼續下去，並將為全年的增長做出貢獻。

On Slide 10, moving on to Cosentyx.

在幻燈片 10 上，轉到 Cosentyx。

Sales were up quarter-on-quarter despite the increased rebates that we had mentioned at the end of last year that were necessary to defend our formulary position.

儘管我們在去年年底提到了捍衛我們的處方地位所必需的回扣增加，但銷售額仍環比增長。

So this is due, I think, to the best-in-class profile of this product.

因此，我認為這是由於該產品具有一流的配置文件。

Remember that Cosentyx remains the only anti-IL-17 approved in psoriasis, psoriatic arthritis and ankylosing spondylitis.

請記住，Cosentyx 仍然是唯一被批准用於治療銀屑病、銀屑病關節炎和強直性脊柱炎的抗 IL-17 藥物。

It's the only fully human anti-IL-17 with close to 0 immunogenicity and we have a unique long-term efficacy profile with Phase III data beyond 4 years.

它是唯一一種免疫原性接近於 0 的完全人源抗 IL-17，我們擁有獨特的長期療效概況和超過 4 年的 III 期數據。

So we're going to continue to build the profile of this drug as momentum continues.

因此，隨著勢頭的繼續，我們將繼續建立這種藥物的形象。

And on Slide 11, I want to step back just for a minute and remind everybody of the potential of this new drug.

在幻燈片 11 上，我想退後一步，提醒大家注意這種新藥的潛力。

Starting with psoriasis, there are over 3 million patients in the U.S and the 5 big EU countries, and of course, this is the most competitive of the 3 indications.

從銀屑病開始，在美國和歐盟5大國家有超過300萬患者，當然，這是3個適應症中最具競爭力的。

But I think it's worth noting that the IL-17s have really helped expand the total market since launching in 2015.

但我認為值得注意的是，自 2015 年推出以來，IL-17 確實幫助擴大了整個市場。

So it's not necessarily a zero-sum game.

所以這不一定是零和遊戲。

Psoriatic arthritis and ankylosing spondylitis, together are an even greater opportunity with 4.2 million patients between them.

銀屑病關節炎和強直性脊柱炎加在一起是一個更大的機會，它們之間有 420 萬患者。

And the unmet medical need is high in these indications.

在這些適應症中，未滿足的醫療需求很高。

Remember, Cosentyx is the only IL-17 approved to treat in these indications and it will be for some time.

請記住，Cosentyx 是唯一獲准用於治療這些適應症的 IL-17，而且還會持續一段時間。

So we're taking advantage of this and we're going continue to drive Cosentyx.

所以我們正在利用這一點，我們將繼續推動 Cosentyx。

On the next slide, you'll see the launch of Kisqali.

在下一張幻燈片中，您將看到 Kisqali 的發布。

This is our anti-CDK4.

這是我們的抗CDK4。

The Oncology group received approval on March 13th and launched this thing in 24 hours.

Oncology group 3 月 13 日收到批准，並在 24 小時內啟動了這個東西。

We're confident in the launch, it's got a very strong efficacy profile that's visible at 8 weeks due to the rapid response.

我們對此次發布充滿信心，由於反應迅速，它具有非常強大的療效，在 8 週後就可以看到。

We're hearing qualitatively that the safety profile is manageable, and that there are some pretty significant convenience advantages over the competition.

我們定性地聽到安全狀況是可控的，並且與競爭對手相比有一些非常顯著的便利優勢。

So launch preparations are ongoing in Europe, and we expect to get a positive opinion in the second half of the year.

因此，歐洲正在進行發布準備工作，我們希望在下半年獲得積極的意見。

Next slide, Slide number 13, Sandoz, you can see the Biopharmaceuticals business continues to power ahead.

下一張幻燈片，第 13 號幻燈片，Sandoz，您可以看到生物製藥業務繼續向前發展。

It's up 30% year-on-year and we're expecting the growth rates to taper a bit towards the end of this year as we lap strong performance on Zarxio and Glatopa 20 milligram.

同比增長 30%，我們預計隨著 Zarxio 和 Glatopa 20 毫克的強勁表現，增長率將在今年年底有所放緩。

However, there is good momentum in the pipeline overall.

然而，總體而言，管道中的勢頭良好。

For example, you know that we received very recently the positive CHMP opinion on etanercept and rituximab.

例如，您知道我們最近收到了 CHMP 對依那西普和利妥昔單抗的積極意見。

These are going to be big important launches in our biosimilars business, and we've got 5 submissions planned for the U.S. and the EU in 2017.

這些將是我們生物仿製藥業務的重大重要發布，我們計劃在 2017 年向美國和歐盟提交 5 份申請。

Now on to Slide 14, I want to go a little bit deeper on Alcon.

現在轉到幻燈片 14，我想更深入地了解愛爾康。

Vision Care was up 4%, led by contact lenses.

在隱形眼鏡的帶動下，視力保健業務增長了 4%。

Dailies Total1 continues to stand out, and it's driving 7% growth on that total contact lens business.

Dailies Total1 繼續脫穎而出，推動整個隱形眼鏡業務增長 7%。

Surgical, still in a turnaround mode, although down only slightly in the first quarter.

Surgical，仍處於扭虧為盈模式，儘管在第一季度僅略有下降。

Cataract consumables and vit-ret continue to grow nicely, but IOLs were down.

白內障耗材和 vit-ret 繼續良好增長，但 IOL 下降了。

There are, though, positive signs on the Surgical business to give me confidence that we're headed for a turn on that piece.

不過，外科業務方面出現了積極的跡象，讓我相信我們正在轉向這塊業務。

For example, our customer service levels have improved, we're increasing investment in training and education of our customers, and more importantly, you'll see on the next slide, we're investing in launches on the intraocular lens side.

例如，我們的客戶服務水平有所提高，我們正在增加對客戶培訓和教育的投資，更重要的是，您將在下一張幻燈片中看到，我們正在投資於人工晶狀體方面的發布。

On Slide 15, you can see that each of our core geographies now have some innovative intraocular lens that they can leverage.

在幻燈片 15 上，您可以看到我們每個核心地區現在都有一些可以利用的創新人工晶狀體。

So in the U.S., in the first quarter, we achieved FDA approval on ReSTOR 2.5D toric.

所以在美國，第一季度，我們獲得了 FDA 對 ReSTOR 2.5D toric 的批准。

This is an advanced technology IOL, with a premium price.

這是一種技術先進的人工晶狀體，價格不菲。

This is a lens that has a unique design with sharper distance vision and best-in-class stability, which is very important in a toric lens.

這是一款設計獨特的鏡片，具有更清晰的遠視力和一流的穩定性，這在復曲面鏡片中非常重要。

In Europe, we're continuing to drive PanOptix, and we also are about to submit Clareon, which is our new intraocular lens platform.

在歐洲，我們繼續推動 PanOptix，我們也即將提交 Clareon，這是我們新的人工晶狀體平台。

And then in Japan, we've also got a couple of launches, UltraSert, which is very important because 60% of the Japanese market is a preloaded use.

然後在日本，我們也推出了幾次 UltraSert，這非常重要，因為 60% 的日本市場是預裝的。

Now in the background, our review of the Alcon business is ongoing, and as we said in January, we're going to give you a review -- an update on that review by the end of the year.

現在在後台，我們對愛爾康業務的審查正在進行中，正如我們在 1 月份所說，我們將在年底前向您提供審查的最新情況。

So with that, I'm going to turn it over to Harry to take us through the financials.

因此，我將把它交給 Harry，讓我們了解財務狀況。

Harry?

哈利？

Yes, thank you, Joe.

是的，謝謝你，喬。

Good morning, good afternoon, everyone.

大家早上好，下午好。

A quick reminder, the numbers in my presentation will focus on growth rates in constant currencies unless otherwise noted.

快速提醒一下，除非另有說明，否則我的演示文稿中的數字將側重於以固定貨幣計算的增長率。

Slide 17 shows a summary of our performance.

幻燈片 17 顯示了我們的績效摘要。

Overall sales grew 2% to $11.5 billion in quarter 1. This is the first quarter with Gleevec Generics in both Europe and the U.S. However, our growth drivers, including Cosentyx and Entresto, more than offset the impact of generic erosion.

第一季度總銷售額增長 2%，達到 115 億美元。這是格列衛仿製藥在歐洲和美國的第一季度。但是，我們的增長動力，包括 Cosentyx 和 Entresto，足以抵消仿製藥侵蝕的影響。

In quarter 1, core operating income was $3 billion, down 5% from the prior year quarter, due to generic erosion and large investments.

第一季度，由於仿製藥侵蝕和大量投資，核心營業收入為 30 億美元，較上年同期下降 5%。

This was slightly better than expected, mainly due to productivity efforts.

這略好於預期，主要是由於生產力方面的努力。

Net income was $1.7 billion for the first quarter, down 15%, mainly due to a net charge related to the discontinuation of serelaxin.

第一季度淨收入為 17 億美元，下降 15%，主要原因是與停用 serelaxin 相關的淨費用。

Core EPS was $1.13, broadly in line with prior year core operating income, as decline of core operating income was offset by higher income from associate companies.

核心每股收益為 1.13 美元，與上一年的核心營業收入基本一致，因為核心營業收入的下降被聯營公司收入的增加所抵消。

Free cash flow in quarter 1 was a strong, with $1.7 billion, up $0.3 billion versus last year, mainly due to stronger cash flow from operations.

第一季度的自由現金流強勁，為 17 億美元，比去年同期增加 3 億美元，這主要是由於運營現金流強勁。

On Slide 18, just a quick reminder of currency impacts.

在幻燈片 18 上，只是快速提醒一下貨幣影響。

If mid-April rates would prevail, we expect the full year impact to be negative 2% on the top line, with negative 3% in quarter 2. On core operating income, we would expect the full year impact to be negative 3%, with negative 4% in quarter 2.

如果 4 月中旬的利率佔上風，我們預計全年收入的影響為負 2%，第二季度為負 3%。在核心營業收入方面，我們預計全年影響為負 3%，第二季度為負 4%。

On Slide 19, you can see the growth drivers from the Innovative Medicines division.

在幻燈片 19 上，您可以看到創新藥物部門的增長動力。

Joe already talked about Cosentyx and Entresto, but I also would like to highlight some of our Oncology growth drivers, especially Revolade/Promacta growing 35%, Jakavi 34% and Taf + Mek growing 27%.

Joe 已經談到了 Cosentyx 和 Entresto，但我還想強調我們的一些腫瘤學增長動力，尤其是 Revolade/Promacta 增長 35%，Jakavi 增長 34% 和 Taf + Mek 增長 27%。

Additionally, our largest brand, Gilenya, exhibited continued volume growth.

此外，我們最大的品牌 Gilenya 的銷量持續增長。

In total, our key Innovative Medicines growth drivers increased plus 27% in quarter 1, which more than offset generic erosion and resulted in the Innovative Medicines division growing plus 2%.

總的來說，我們主要的創新藥物增長驅動因素在第一季度增長了 27%，這大大抵消了仿製藥的侵蝕，並導致創新藥物部門增長了 2%。

Now let's turn to margins by division on Slide 20.

現在讓我們轉向幻燈片 20 上的按部門劃分的利潤率。

Quarter 1 group core ROS was 26.1% of sales, down 1.8 percentage points as we made investments behind our growth drivers in each division.

第一季度集團核心 ROS 佔銷售額的 26.1%，下降了 1.8 個百分點，因為我們在每個部門的增長動力背後進行了投資。

This includes Cosentyx, Entresto, the Kisqali launch in quarter 1, Sandoz biosimilars and the Alcon growth plan.

這包括 Cosentyx、Entresto、第一季度推出的 Kisqali、Sandoz 生物仿製藥和 Alcon 增長計劃。

Additionally, margin was impacted by continued generic erosion, mainly from Gleevec.

此外，利潤率受到持續仿製藥侵蝕的影響，主要來自格列衛。

The Alcon core margin was 13.2% of net sales, and as I mentioned in January, we expect 2017 to be the trough year for Alcon margins before improving over time to be in line with industry peers.

愛爾康的核心利潤率為淨銷售額的 13.2%，正如我在 1 月份提到的，我們預計 2017 年將是愛爾康利潤率低谷的一年，然後隨著時間的推移會有所改善，與行業同行保持一致。

On Slide 21, you see our free cash flow reach $1.7 billion in the quarter, up $0.3 billion, mainly driven by lower use of working capital from the timing of collections and payments and prior-year legal settlement payments, which more than offset the lower operating income.

在幻燈片 21 上，您會看到本季度我們的自由現金流達到 17 億美元，增加了 3 億美元，這主要是由於收付款時間和上一年法律結算付款的營運資金使用減少，這抵消了較低的支出營業收入。

Slide 22 reflects the change in net debt during the quarter.

幻燈片 22 反映了本季度淨債務的變化。

The net debt increase is mainly driven by our annual dividend payment of $6.5 billion.

淨債務增加的主要原因是我們每年支付 65 億美元的股息。

Cash outflow from share repurchases net of option proceeds of $0.2 billion amounted to $1.1 billion.

扣除期權收益後的股票回購現金流出 2 億美元，達 11 億美元。

16.2 million shares were repurchased under the up to 5 billion share buyback program announced in January.

根據 1 月份宣布的高達 50 億股的股票回購計劃，回購了 1620 萬股股票。

2.7 million shares were repurchased to mitigate dilution related to equity-based participation plans.

回購了 270 萬股股票，以減輕與基於股權的參與計劃相關的稀釋。

Now let's turn to the key drivers for 2017 shown on Slide 23.

現在讓我們轉向幻燈片 23 中顯示的 2017 年的主要驅動因素。

On the top line, we expect growth from Cosentyx, Entresto and the new Oncology assets to continue throughout the year.

最重要的是，我們預計 Cosentyx 、 Entresto 和新的腫瘤學資產將在全年繼續增長。

We launched Kisqali in March and are continuing to invest behind the launch.

我們在 3 月推出了 Kisqali，並將繼續投資推出。

Sales of Kisqali are expected to be modest in half 1 then we expect to see a ramp up in half 2. Additionally, the Gleevec Generic impact is expected to be stronger in the balance of the year as we expect more entrants in the U.S. and Europe in the remainder of 2017.

預計 Kisqali 的銷售額將在 1 的一半中保持溫和，然後我們預計將在 2 的一半中出現增長。此外，由於我們預計美國和歐洲會有更多的進入者，格列衛仿製藥的影響預計將在今年餘下時間增加在 2017 年剩餘時間裡。

Now turning to core operating income.

現在轉向核心營業收入。

In half 1, we expect core operating income to be impacted by the investments we are making in Innovative Medicines division launches and the Alcon growth plan.

在上半年，我們預計核心營業收入將受到我們在創新藥物部門啟動和愛爾康增長計劃方面的投資的影響。

This impact is expected to be lower in half 2 as we lap investment increases in the prior-year base.

隨著我們在前一年的基礎上增加投資，預計這一影響將在下半年降低。

With these investments and the full quarter impact of Gleevec's generics in U.S. and Europe, quarter 2 core operating income could decline in the range of mid-single digits in constant currency versus prior year.

憑藉這些投資以及 Gleevec 仿製藥在美國和歐洲的整個季度影響，第二季度核心營業收入可能會以固定匯率計算的中個位數範圍內下降，與上一年相比。

There's some variability around this range depending on the Gleevec erosion and the launch uptake curves.

根據 Gleevec 侵蝕和發射吸收曲線，此範圍內存在一些可變性。

On Slide 24, I want to confirm our full year group guidance.

在幻燈片 24 上，我想確認我們全年的小組指導。

For the group, we expect net sales to be broadly in line with the prior year in constant currencies.

對於該集團，我們預計淨銷售額將與上年大致持平（以固定匯率計算）。

On the divisional level, we are slightly increasing our outlook for the Innovative Medicines division due to continued good sales momentum.

在部門層面，由於持續良好的銷售勢頭，我們略微提高了對創新藥物部門的展望。

We are revising our Sandoz sales guidance to broadly in line with prior year.

我們正在修改我們的 Sandoz 銷售指南，以與上一年大致保持一致。

To be conservative, we have removed Glatopa 40 milligram from the 2017 forecast assumptions.

為保守起見，我們從 2017 年的預測假設中刪除了 Glatopa 40 毫克。

We confirm our group core operating income guidance of broadly in line with prior year to a low single-digit decline.

我們確認我們的集團核心營業收入指引與上一年基本一致，下降幅度較低。

And with that, I turn it over to Vas.

然後，我把它交給 Vas。

Thank you, Harry.

謝謝你，哈利。

Starting with Slide 26, we had a very solid quarter in terms of advancing our innovative and deep pipeline across Innovative Medicines and Sandoz biosimilars.

從幻燈片 26 開始，我們在推進創新藥物和 Sandoz 生物仿製藥的創新和深度管道方面有一個非常穩固的季度。

In particular, we were pleased with the progress we've made on our potential blockbusters, overcoming some of the setbacks that Joe mentioned.

特別是，我們對我們在潛在大片上取得的進展感到高興，克服了喬提到的一些挫折。

What I'd like to do is walk you through some of the key updates we have on these programs as well as other important pipeline events that have happened in the quarter.

我想做的是帶您了解我們對這些計劃的一些關鍵更新以及本季度發生的其他重要管道事件。

Turning to Slide 27, as Joe mentioned, Kisqali was approved and launched in the U.S. with some important features that we believe -- that gives us confidence in the Kisqali's outlook.

轉到幻燈片 27，正如 Joe 提到的那樣，Kisqali 在美國獲得批准並推出，我們認為它具有一些重要的特點——這讓我們對 Kisqali 的前景充滿信心。

First in terms of efficacy, along with the 44% reduction in risk, we have a median PFS of 25.3 months, along with a PFS benefit that's seen as early as 8 weeks that is not only evident in PFS curves but also in tumor burden.

首先在療效方面，連同風險降低 44%，我們的中位 PFS 為 25.3 個月，以及早在 8 週就可以看到的 PFS 獲益，這不僅在 PFS 曲線上很明顯，而且在腫瘤負荷方面也很明顯。

In addition, overall, the safety profile of Kisqali based on the label is manageable and predictable.

此外，總體而言，基於標籤的 Kisqali 安全性是可管理和可預測的。

And as guided in January, we do see that the final ECG monitoring required with Kisqali is in line with the requirements for visits that are already in place with the existing CDK4/6 inhibitor.

根據 1 月份的指導，我們確實看到 Kisqali 所需的最終 ECG 監測符合現有 CDK4/6 抑製劑已經到位的就診要求。

And finally, in terms of convenience, we have a single dose strength with 800 milligrams, as well as a second dose strength at 400 milligrams that allows us easy dose adjustments without need for new Rx.

最後，就便利性而言，我們有 800 毫克的單劑量強度和 400 毫克的第二劑量強度，這使我們無需新 Rx 即可輕鬆調整劑量。

In addition, Kisqali can be taken with or without food, which provides, I think, a convenience to patients.

此外，Kisqali 可以與或不與食物一起服用，我認為這為患者提供了便利。

And so we have a nice profile overall with Kisqali.

因此，我們對 Kisqali 的總體印像很好。

Moving to Slide 28, when you look overall at our program for Kisqali, we continue to advance MONALEESA-3 and MONALEESA-7 with readouts expected in the back half of 2017, as well as now we are now moving forward with our adjuvant trials both in high-risk and medium-risk patients.

轉到幻燈片 28，當您整體查看我們的 Kisqali 計劃時，我們將繼續推進 MONALEESA-3 和 MONALEESA-7，預計將在 2017 年下半年公佈結果，現在我們正在推進我們的輔助試驗在高危和中危患者中。

In addition, we're continuing to explore Kisqali in other tumor types through IATs and collaborations and we'll keep the markets updated as and when we move Kisqali into other new indications.

此外，我們將繼續通過 IAT 和合作探索 Kisqali 在其他腫瘤類型中的應用，當我們將 Kisqali 轉移到其他新適應症時，我們將及時更新市場。

Then moving to our immuno-oncology strategy on Slide 29, there are 3 key elements of our strategy.

然後轉到幻燈片 29 上的免疫腫瘤學策略，我們的策略有 3 個關鍵要素。

As Joe mentioned, we continue to advance our CAR-T programs across multiple tumor types, and I'll provide you a deeper update in the subsequent slides.

正如 Joe 所提到的，我們將繼續推進我們的 CAR-T 計劃跨越多種腫瘤類型，我將在隨後的幻燈片中為您提供更深入的更新。

As well, we want to build a strong platform with our PD-1 inhibitor PDR 001, and to that end, we are now bringing forward 5 studies over the course of Q1 and Q2 of this year.

此外，我們希望用我們的 PD-1 抑製劑 PDR 001 建立一個強大的平台，為此，我們現在將在今年第一季度和第二季度進行 5 項研究。

Notably, we have already started pivotal studies for melanoma in combination with Tafinist -- Mekinist and Tafinlar, as well as in neuroendocrine tumors.

值得注意的是，我們已經開始結合 Tafinist（Mekinist 和 Tafinlar）以及神經內分泌腫瘤對黑色素瘤進行關鍵研究。

So we'll continue to see solid progress with PDR 001 over the course of this year.

因此，我們將在今年繼續看到 PDR 001 取得穩步進展。

In addition, we continue to progress our portfolio of 15 second-generation agents in mono or combo studies, and we continue to expect the readouts of those programs to come in the back half of 2017.

此外，我們繼續在單一或組合研究中推進我們的 15 個第二代代理的組合，我們繼續期望這些程序的讀數將在 2017 年下半年出現。

Moving -- to Slide 30 and going a little bit deeper into CAR-T.

移動到幻燈片 30 並更深入地了解 CAR-T。

As Joe mentioned, CTL019 received priority review for FDA in pediatric ALL, where we're on track overall with our registration program with the FDA in terms of inspections in manufacturing as well as in the clinical sites.

正如喬提到的，CTL019在兒科 ALL 中獲得了 FDA 的優先審查，我們在製造和臨床現場的檢查方面與 FDA 的註冊計劃總體上步入正軌。

We are also on track towards a filing in Europe in the back half of 2017.

我們也有望在 2017 年下半年在歐洲提交申請。

You also saw that we received breakthrough therapy designation for CAR-T 19 in DLBCL based on the interim data from the ELIANA study.

您還看到，根據 ELIANA 研究的中期數據，我們在 DLBCL 中獲得了 CAR-T 19 的突破性治療指定。

We plan to present the results of this study in June in Lugano at the International Conference for Malignant Lymphoma.

我們計劃於 6 月在盧加諾舉行的惡性淋巴瘤國際會議上公佈這項研究的結果。

And we also are on track for filing both in the U.S. and Europe in the back half of 2017.

我們也有望在 2017 年下半年在美國和歐洲提交申請。

Okay, moving to Slide 31.

好的，轉到幻燈片 31。

When you look at future directions in CAR-T therapy, we are continuing to invest in manufacturing improvements, optimizing the current platform, as well as investing in automation that will allow us to ensure adequate supply for both ALL and DLBCL, as well as to support future indications in CAR-T.

當您展望 CAR-T 療法的未來方向時，我們將繼續投資於製造改進、優化當前平台以及投資於自動化，這將使我們能夠確保 ALL 和 DLBCL 的充足供應，以及支持 CAR-T 的未來適應症。

Importantly, we're also progressing programs now in hematologic malignancies, including BCMA in multiple myeloma, as well as a humanized CAR-T CTL 119 in combination with ibrutinib in chronic lymphocytic leukemia.

重要的是，我們現在還在推進血液系統惡性腫瘤的項目，包括多發性骨髓瘤中的 BCMA，以及人源化 CAR-T CTL 119 與依魯替尼聯合治療慢性淋巴細胞白血病。

We continue to evaluate also moving into earlier lines of therapy in DLBCL as well as other B-cell malignancies.

我們繼續評估 DLBCL 以及其他 B 細胞惡性腫瘤的早期治療方案。

On the solid tumor side, we are advancing 2 programs right now: A CAR-T against EGFR, which is targeted in Glioblastoma Multiforme, and we'll continue to provide updates as data becomes available in this program; as well as a CAR-T against Mesothelin, which is currently progressing in both ovarian cancer, as well as Mesothelioma.

在實體瘤方面，我們目前正在推進 2 個項目：針對 EGFR 的 CAR-T，針對多形性膠質母細胞瘤，我們將在該項目獲得可用數據時繼續提供更新；以及針對間皮素的 CAR-T，目前正在卵巢癌和間皮瘤中取得進展。

So taken together, we have built a robust platform with our CAR-T therapy technology.

因此，我們已經用我們的 CAR-T 療法技術建立了一個強大的平台。

We've invested in a manufacturing capability, and we'll continue to progress this portfolio of medicines and learn as we actually progress these medicines through the clinic.

我們已經投資於製造能力，我們將繼續推進這一藥物組合，並在我們通過診所實際推進這些藥物時學習。

Now moving to Slide 32, you will remember in late last year, we acquired SEG101 from a company formerly known Selexys, and what we've done now is clarified our filing strategy to -- in the U.S. with a filing in 2018.

現在轉到 Slide 32，你會記得去年年底，我們從一家前身為 Selexys 的公司收購了 SEG101，我們現在所做的是澄清我們的備案策略——在美國，2018 年提交了一份文件。

Now importantly, with sickle cell disease, this is a disease that impacts over 100,000 patients in the U.S. and the EU and is an important cause of hospital utilization and overall health care utilization with over 200,000 visits in the U.S. annually alone.

現在重要的是，對於鐮狀細胞病，這是一種影響美國和歐盟超過 100,000 名患者的疾病，是醫院利用率和整體醫療保健利用率的重要原因，僅在美國每年就診人數就超過 200,000 人次。

In the Phase II study, we demonstrated consistent efficacy and benefits across the primary and secondary endpoints and demonstrated robust safety profile.

在 II 期研究中，我們展示了主要和次要終點的一致療效和益處，並展示了穩健的安全性。

It was on this basis that our discussions with FDA indicate that we can move forward with a filing on this Phase IIb study.

正是在這個基礎上，我們與 FDA 的討論表明我們可以推進這項 IIb 期研究的備案。

However, given that this program was -- is being rapidly accelerated, we do need to bridge our manufacturing platform from the manufacturing platform used in Phase I and Phase II studies to the final manufacturing platform, which will require us to do an additional PK study.

然而，鑑於該計劃正在迅速加速，我們確實需要將我們的製造平台從第一階段和第二階段研究中使用的製造平台連接到最終製造平台，這將需要我們進行額外的 PK 研究.

Based on that study result, we are confident that we'll be able to then file in the back half of 2018.

根據該研究結果，我們有信心能夠在 2018 年下半年提交申請。

Moving to cardiovascular disease, we had important progress in our cardiovascular pipeline, including completing the PARAGON enrollment in preserved ejection fraction heart failure, as well as achieving the protocol specified number of events in the CANTOS study.

轉向心血管疾病，我們在心血管管道方面取得了重要進展，包括完成保留射血分數心力衰竭的 PARAGON 登記，以及在 CANTOS 研究中達到協議規定的事件數量。

However, we did have an important setback with respect to serelaxin, which did not meet either of its primary endpoints.

然而，我們在 serelaxin 方面確實遇到了一個重要的挫折，它沒有達到它的任何一個主要終點。

Just as a reminder, based on high unmet need and the fact that in 2 separate studies, previously, and in post hoc analyses we had seen a mortality benefit, and based on the guidance of regulators and experts we had taken forward this program to try to address this important unmet need, this important business opportunity and to meet our ethical obligation to patients.

提醒一下，基於大量未滿足的需求以及在之前和事後分析中我們已經看到死亡率降低的 2 項獨立研究這一事實，並且根據監管機構和專家的指導，我們已經推進該計劃以嘗試解決這一重要的未滿足需求，這一重要的商業機會，並履行我們對患者的道德義務。

However, the study did not go our way.

然而，這項研究並沒有如我們所願。

We plan to continue to fully mine the data, as well as present it at an upcoming medical Congress and we'll look forward to continuing to learn from this experience as we move to future cardiovascular outcomes studies.

我們計劃繼續充分挖掘數據，並在即將召開的醫學大會上展示這些數據，我們期待著在未來的心血管結局研究中繼續從這些經驗中吸取教訓。

Moving to neuroscience on Slide 34, with BAF312 based on conversations with the FDA, we are now able to clarify that we will file in the first half of 2018 in relapsing MS, with the final labeling of the unique population we studied to be a review issue.

轉到幻燈片 34 上的神經科學，根據與 FDA 的對話使用 BAF312，我們現在能夠澄清我們將在 2018 年上半年提交復發性 MS，我們研究的獨特人群的最終標籤是審查問題。

Now in this EXPAND study, we studied a population that was unlike any population previously studied.

現在，在這項 EXPAND 研究中，我們研究了一個不同於之前研究過的任何人群的人群。

This SPMS trial was the first trial to show a benefit for these patients, and when you look at the diagram here, you can clearly see whether it was from an age range, time of onset, overall disease severity, we studied a unique population in this trial.

這個 SPMS 試驗是第一個顯示對這些患者有益的試驗，當你看這裡的圖表時，你可以清楚地看到它是否來自年齡範圍、發病時間、總體疾病嚴重程度，我們研究了一個獨特的人群這次審判。

And we plan to continue to have discussions with FDA to ensure that we have this properly reflected, which is also the agency's ultimate goal.

我們計劃繼續與 FDA 進行討論，以確保我們正確反映這一點，這也是該機構的最終目標。

Now we will need to file this in the first part of 2018 for two primary reasons: one, we will collect additional safety data in an extension study that's to the EXPAND study and an extension trial; and in addition, we need to finalize the manufacturing platform for -- on the CMC side given the complexity of the BAF manufacturing process.

現在我們需要在 2018 年上半年提交此文件，主要原因有兩個：第一，我們將在 EXPAND 研究和擴展試驗的擴展研究中收集額外的安全數據；此外，鑑於 BAF 製造過程的複雜性，我們需要在 CMC 方面完成製造平台。

Now in terms of Europe, we have completed 4 interactions with EU health authorities, and we'll be working towards a scientific advice in the coming months to formalize our approach in Europe.

現在就歐洲而言，我們已經完成了與歐盟衛生當局的 4 次互動，我們將在未來幾個月內努力尋求科學建議，以正式確定我們在歐洲的方法。

And we'll provide you an update once we have that final advice from the European health authorities.

一旦我們收到歐洲衛生當局的最終建議，我們將為您提供最新信息。

Moving to Slide 35, we also have expanded our collaboration with Amgen on AMG 334.

轉到 Slide 35，我們還擴大了與 Amgen 在 AMG 334 上的合作。

Now just as a reminder, migraine is one of the top 10 leading causes of disability in the world, primarily effecting working-age women, which is an important patient population, when you think about productivity for economies, as well as the population that payers will want to support reimbursement of a medicine for.

現在提醒一下，偏頭痛是世界上導致殘疾的 10 大主要原因之一，主要影響工作年齡的女性，當您考慮經濟生產力以及支付費用的人口時，她們是一個重要的患者群體將要支持報銷的一種藥。

We have a unique medicine here, which is the fully human, potent, selective CGRP receptor antagonist.

我們這裡有一種獨特的藥物，它是完全人源化的、有效的、選擇性的 CGRP 受體拮抗劑。

We're the only drug on -- that's moving forward that targets the receptor.

我們是唯一一種針對受體的藥物——它正在向前發展。

And we're the only medicine thus far to actually readout late stage studies, with consistent data in Phase II and Phase III studies.

到目前為止，我們是唯一一種真正讀出後期研究的藥物，在 II 期和 III 期研究中具有一致的數據。

Now based on this and our excitement about the overall profile, we have expanded our partnership with Amgen.

現在，基於這一點以及我們對整體概況的興奮，我們擴大了與 Amgen 的合作夥伴關係。

We will continue to have exclusive rights to the ex U.S., ex Japan market and we'll co-commercialize AMG to leverage -- in the U.S. to leverage our multiple sclerosis capability and our multiple sclerosis sales force with Gilenya.

我們將繼續擁有前美國、前日本市場的獨家權利，我們將共同商業化 AMG 以利用——在美國利用我們的多發性硬化症能力和我們與 Gilenya 的多發性硬化症銷售隊伍。

Moving to Slide 36, we also announced in the immunology and dermatology unit a new collaboration with Allergan that strengthens our portfolio in NASH.

轉到幻燈片 36，我們還在免疫學和皮膚病學部門宣布了與 Allergan 的新合作，以加強我們在 NASH 方面的產品組合。

As you know, we have a FXR agonist progressing in Phase IIb studies, with a really unique profile versus the other FXR agonists out there in the industry and to complement that, we will now collaborate with Allergan on a combination study with their CCR 25 inhibitor.

如您所知，我們有一種 FXR 激動劑正在進行 IIb 期研究，與業內其他 FXR 激動劑相比具有真正獨特的特徵，為了補充這一點，我們現在將與 Allergan 合作進行一項與他們的 CCR 25 抑製劑的聯合研究.

Now this builds on a portfolio we've been working on for some time, which includes an option agreement for emricasan, a pan-caspase inhibitor in the later stages of liver disease as well as LIK 066, which is our SGLT 1/2 inhibitor and has shown significant impact on obesity.

現在，這建立在我們已經研究了一段時間的產品組合的基礎上，其中包括 emricasan 的選擇權協議，一種用於肝病後期的泛半胱天冬酶抑製劑，以及我們的 SGLT 1/2 抑製劑 LIK 066並顯示出對肥胖的顯著影響。

We also have multiple earlier stage assets that are advancing in the clinic.

我們還有多個早期資產正在臨床推進。

So overall, we're pleased with not only our portfolio in NASH but also in chronic liver diseases overall.

所以總的來說，我們不僅對我們在 NASH 的投資組合感到滿意，而且對整個慢性肝病的投資組合感到滿意。

Moving to Slide 37, in ophthalmology I wanted to provide an update on RTH258 given the interest in the overall design of this study.

轉到幻燈片 37，考慮到對本研究總體設計的興趣，我想在眼科方面提供 RTH258 的更新。

In RTH -- in our pivotal RTH study, we have 2 main Phase III studies, HAWK and HARRIER.

在 RTH 中——在我們關鍵的 RTH 研究中，我們有兩個主要的 III 期研究，HAWK 和 HARRIER。

Both of these studies have near equivalent designs.

這兩項研究的設計幾乎相同。

The only difference is in HAWK, we also test a 3-milligram dose.

唯一的區別是在 HAWK 中，我們還測試了 3 毫克的劑量。

In both of these studies, patients are randomized to either aflibercept or to RTH.

在這兩項研究中，患者被隨機分配到阿柏西普或 RTH。

And after an induction period, patients in the RTH arm receive RTH every 12 weeks on quarterly dosing.

在誘導期後，RTH 組的患者每 12 週接受一次 RTH，按季度給藥。

Then based on protocol-specified criteria, either best corrected visual acuity or retinal thickness, physicians after consulting with the reading center can down -- up the frequency of injections to 8 weeks.

然後，根據協議規定的標準（最佳矯正視力或視網膜厚度），醫生在諮詢閱讀中心後可以將注射頻率降低至 8 週。

Now overall, we have agreed with FDA with an analysis plan that will allow us then to pursue an indication for 12-week dosing or with 8-week dosing or a mix, depending on the final data that we readout.

現在總的來說，我們已經與 FDA 達成了一項分析計劃，該計劃將使我們能夠根據我們讀出的最終數據尋求 12 週給藥或 8 週給藥或混合給藥的適應症。

So overall, we look forward to finalizing this study and we continue to expect a readout mid this year.

因此，總的來說，我們期待完成這項研究，並繼續期待今年年中的結果。

Moving to Slide 38, we've also recently in-licensed ECF843, which is an analog of human lubricin, a naturally occurring protein in the tears that allows us to have really the first compound in the industry that has shown the ability to improve signs and symptoms in a single study.

轉到幻燈片 38，我們最近還獲得了 ECF843 的許可，它是人類潤滑素的類似物，是眼淚中天然存在的蛋白質，使我們能夠真正擁有業內第一個顯示出改善體徵能力的化合物和單一研究中的症狀。

Along with the recent acquisition of UNR 844 in presbyopia, this expands our front of the eye pipeline and allows us to continue to build out our ophthalmology portfolio, along with Lucentis and with RTH.

連同最近收購用於治療老花眼的 UNR 844，這擴大了我們的眼部管線，使我們能夠與 Lucentis 和 RTH 一起繼續構建我們的眼科產品組合。

Moving to Slide 39, as Joe already mentioned, we also received 2 CHMP positive opinions in April for our biosimilar etanercept and our biosimilar rituximab, and we remain on track for 5 additional filings, including filings for biosimilar adalimumab in both U.S. and in Europe.

轉到幻燈片 39，正如 Joe 已經提到的，我們在 4 月份還收到了 2 條 CHMP 對我們的生物仿製藥依那西普和生物仿製藥利妥昔單抗的積極意見，我們仍在按計劃提交另外 5 份申請，包括在美國和歐洲提交的生物仿製藥阿達木單抗申請。

So overall, when you go to Slide 40, we had strong progress on our 2017 milestones.

所以總的來說，當你看 Slide 40 時，我們在 2017 年的里程碑上取得了長足的進步。

We're very pleased with the progress and we'll look forward to keeping you up to speed as events occur.

我們對取得的進展感到非常滿意，我們期待著讓您及時了解事件的發生。

So with that, I will hand it back to Joe.

因此，我將把它交還給喬。

Thanks, Vas.

謝謝，瓦斯。

So to conclude, we had a solid quarter.

總而言之，我們有一個穩定的季度。

Our innovation momentum continues and we made significant progress on turning Alcon.

我們的創新勢頭仍在繼續，我們在轉變愛爾康方面取得了重大進展。

So with that, I'd like to open the call to questions.

因此，我想開始提問。

(Operator Instructions) Our first question comes from the line of Jeff Holford from Jefferies.

（操作員說明）我們的第一個問題來自 Jefferies 的 Jeff Holford。

Just -- first for Vas, wondering if you can just give us a little bit more color on BAF312.

只是 - 首先是 Vas，想知道你是否可以在 BAF312 上給我們多一點顏色。

Are there any specific safety concerns that have come up from the FDA that they are asking you to address within the EXPAND study?

FDA 是否要求您在 EXPAND 研究中解決任何具體的安全問題？

And then just on the population, I just wonder how precise maybe your conversations with the FDA went in terms of how you might word that population.

然後就人口而言，我只是想知道您與 FDA 的談話在您如何表達該人口方面可能有多精確。

Wonder if you can help us a little bit at all to help us model peak sales there.

想知道您是否可以幫助我們一點點幫助我們建立那裡的銷售高峰期模型。

And then just on potentially from Harry, in the past, you've given us some very helpful guidance around the quarters in terms of core operating income growth or declines.

然後就可能來自哈利，過去，你在核心營業收入增長或下降方面為我們提供了一些非常有用的指導。

I wonder if you might help us a little bit with the second quarter just so we can get our phasing of operating income right for the year.

我想知道您是否可以在第二季度為我們提供一些幫助，以便我們能夠正確地調整全年的營業收入。

Okay, Vas?

好的，瓦斯？

So in BAF in terms of the safety profile, we saw a profile that's similar to other S1P modulators with 1 notable difference that we are going to continue to explore the potential to avoid first dose cardiac monitoring.

因此，在 BAF 的安全性方面，我們看到了一個類似於其他 S1P 調製器的配置文件，但有一個顯著差異，我們將繼續探索避免首次劑量心臟監測的可能性。

So that's really a potential upside, but we'll need to fully analyze the data to see if that's going to be defensible.

所以這確實是一個潛在的好處，但我們需要全面分析數據，看看這是否站得住腳。

In terms of the precision of the discussion, we explored with FDA in detail how best to pursue a secondary progressive MS indication and labeling.

在討論的精確性方面，我們與 FDA 詳細探討瞭如何最好地追求二次進展 MS 適應症和標籤。

And I think our agreement with the agency, the best path forward is to pursue RMS and then try to clearly describe the unique population studied in the indication statement and in the clinical trial section.

而且我認為我們與該機構的協議，最好的前進道路是追求 RMS，然後嘗試在適應症聲明和臨床試驗部分清楚地描述所研究的獨特人群。

Harry?

哈利？

Yes, Jeff, on a quarter 2 core income, I mentioned in my speech that we would expect mid-single-digit decline in constant currencies, basically 2 effects.

是的，傑夫，關於第二季度的核心收入，我在演講中提到我們預計不變貨幣的中個位數下降，基本上是 2 個影響。

Number one, continued investment in the launches and the growth plans; and number two, we expect more entrants on -- on the Gleevec in U.S. and Europe.

第一，繼續投資於發布和增長計劃；第二，我們預計會有更多的進入者——在美國和歐洲的 Gleevec 上。

The next question comes from the line of Matthew Weston from Cr?dit Suisse.

下一個問題來自 Cr?dit Suisse 的 Matthew Weston。

Three questions, if I can, please.

三個問題，如果可以的話，請。

Joe, in your introductory comments, you described CAR-T is going to be big business in Oncology.

喬，在你的介紹性評論中，你描述了 CAR-T 將成為腫瘤學的大生意。

Clearly, the peak sales and number of patients to deal with is significant.

顯然，銷售高峰期和要處理的患者數量非常重要。

But I'd be very interested how you see the launch ramp for the product.

但我對您如何看待該產品的啟動坡道非常感興趣。

Should we expect a very cautious rollout within hospitals and treatment centers, with you restricting it to a small number of very capable specialist centers?

我們是否應該期望在醫院和治療中心內非常謹慎地推出，將其限制在少數非常有能力的專科中心？

Or can we imagine this as having a more normal high impact Oncology launch?

或者我們可以將其想像為具有更正常的高影響腫瘤學發射嗎？

Secondly, on Gilenya, still a very important product for Novartis, one that wasn't really mentioned in the slides, but where trends seem to have taken a significant move negative.

其次，關於 Gilenya，它仍然是諾華（Novartis）公司非常重要的產品，幻燈片中並沒有真正提到它，但趨勢似乎已經採取了重大的負面舉措。

Can you explain what you think is happening within the MS market in terms of volume declines and how payers are acting in MS around rebating and price in the U.S?

您能否解釋一下您認為 MS 市場在銷量下降方面正在發生什麼，以及付款人在 MS 中如何圍繞美國的折扣和價格行事？

And then Vas, you mentioned that you have the CANTOS data in-house.

然後 Vas，你提到你內部有 CANTOS 數據。

Can you just remind us in terms of timing of release when we should anticipate the results of that study?

您能否就發佈時間提醒我們，我們應該在什麼時候預測該研究的結果？

Okay, thanks, Matthew.

好的，謝謝，馬修。

Starting with CAR-T, remember that our first indication is pediatric acute lymphoblastic leukemia.

從 CAR-T 開始，請記住我們的第一個適應症是小兒急性淋巴細胞白血病。

This is a quite small patient population.

這是一個相當小的患者群體。

So let's say, we achieve approval and start selling in the back half of 2017.

這麼說吧，我們在 2017 年下半年獲得批准並開始銷售。

You should expect a relatively slow ramp.

你應該期待一個相對緩慢的斜坡。

Then with DLBCL, we said we intend to file this year.

然後對於 DLBCL，我們說我們打算今年提交。

Let's say it's later this year.

假設是今年晚些時候。

Then you would expect us to be starting to sell in 2018.

然後你會期望我們在 2018 年開始銷售。

I think that while the patient population is large and we do think that this will be, obviously, a blockbuster potential, you would expect a slower ramp than you would ordinarily.

我認為，雖然患者人數眾多，而且我們確實認為這顯然具有重磅炸彈的潛力，但您會期望比平時更慢的增長速度。

Bruno, do want to add anything to that?

布魯諾，你想補充什麼嗎？

Yes, and the very reason, Joe, is that essentially, those products would be administered in transplant centers.

是的，喬，真正的原因是，這些產品基本上將在移植中心進行管理。

So obviously, there will be a limitation to the ramp-up.

很明顯，提升會受到限制。

Paul, on Gilenya?

保羅，在 Gilenya？

So thank you, Matthew.

所以謝謝你，馬修。

So you're correct, Gilenya remains a very important medicine for us and to the patients who benefit from it.

所以你是對的，Gilenya 對我們和受益於它的患者來說仍然是一種非常重要的藥物。

You probably also know that we grew overall versus previous year globally, more than 5%, and we're pleased with that and that was almost entirely volume.

你可能也知道我們在全球範圍內與上一年相比整體增長了 5% 以上，我們對此感到滿意，這幾乎完全是銷量。

In U.S. more modest growth, of course, but we held our share.

當然，在美國，增長更為溫和，但我們保持了我們的份額。

And I think the important thing there is, as you point out, the market has definitely slowed down both in volume and value, and it slowed down in some of the more established or older treatments, if you like, the injectables.

而且我認為重要的是，正如你指出的那樣，市場在數量和價值上都明顯放緩，並且在一些更成熟或更老的治療方法中放緩，如果你願意的話，注射劑。

So we feel good about our position in the market.

所以我們對我們在市場上的地位感到滿意。

As recently as yesterday, we presented -- or this last few days, we presented data at the American Academy of Neurology, reconfirming the long-term benefits of Gilenya on the 4 key measures of disease activity in relapsing MS. So we feel well-placed to continue to perform in this space.

就在昨天，我們在美國神經病學學會上展示了——或者最近幾天，我們展示了數據，再次證實了 Gilenya 在復發 MS 疾病活動的 4 項關鍵指標方面的長期益處。因此，我們有能力繼續在這個領域發揮作用。

As an early indicator, we're pleased also with the new patient starts over the last quarter.

作為早期指標，我們也對上個季度的新患者開始感到滿意。

We'll see how they materialize into patients and revenue, but we're very encouraged by our position, albeit the market has slowed down.

我們將看到它們如何轉化為患者和收入，但我們對我們的立場感到非常鼓舞，儘管市場已經放緩。

And Vas, on CANTOS?

還有 Vas，在 CANTOS 上？

On CANTOS we have the protocol specified number of endpoints in-house, but I've got a 10,000 patient study that was conducted over 6 years.

在 CANTOS 上，我們有內部指定數量的端點的協議，但我有一項超過 6 年的 10,000 名患者研究。

There's a substantial amount of database cleaning that has to happen to fully lock the database.

必須進行大量的數據庫清理才能完全鎖定數據庫。

So we remain on track for a mid-2017 readout, meaning in the June, July timeframe.

因此，我們仍有望在 2017 年年中進行讀數，這意味著在 6 月、7 月的時間範圍內。

Okay.

好的。

Next question, please?

請問下一個問題？

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

下一個問題來自花旗銀行的 Andrew Baum。

Three questions, please.

請教三個問題。

Firstly, Vas, could you talk to Kisqali formulary access?

首先，Vas，你能談談 Kisqali 處方集的使用嗎？

Obviously, it's early days but interested in what you're having to give up on price given the monitoring and safety unique issues associated with the drug.

顯然，現在還為時過早，但考慮到與藥物相關的監測和安全性獨特問題，您對必須放棄的價格感興趣。

Second for Richard on Humira, I think it was the first time you have disclosed the timing of your filing strategy.

其次是 Richard on Humira，我認為這是你第一次披露你的備案策略的時間安排。

I note that it's after the IPR on the 135 scheduling patent.

我注意到這是在 135 調度專利的 IPR 之後。

If 135 is upheld at the PTAB, would you pursue a skinny label in terms of the filing strategy for the product?

如果 135 在 PTAB 得到支持，您會在產品的備案策略方面追求瘦身標籤嗎？

And then finally, a question for Joe and Bruno, on CAR-T and also ABL001, where you're about to launch potentially curative therapies with a very, very high price tag.

最後，關於 CAR-T 和 ABL001，有一個關於 Joe 和 Bruno 的問題，你們將以非常非常高的價格推出潛在的治療療法。

How are you thinking about the pricing structure within the U.S. given the cost of these therapies?

考慮到這些療法的成本，您如何看待美國的定價結構？

And in particular, more broadly, value-based pricing, despite a couple of your initial efforts in Entresto and despite, I see Joe's commentary following the meeting with the U.S. President, the barrier seems to be significant and the movement seems to be slow.

特別是，更廣泛地說，基於價值的定價，儘管你在 Entresto 做了一些初步的努力，儘管我看到了喬在與美國總統會面後的評論，但障礙似乎很大，而且進展似乎很緩慢。

So more broadly on value-based pricing, what is actually moving here and how quickly can it move?

因此，更廣泛地說，在基於價值的定價方面，這裡實際發生了什麼變化，它能以多快的速度變化？

Okay, Bruno, on Kisqali formulary access?

好的，Bruno，關於 Kisqali 處方集的訪問？

So, Andrew, as you can imagine, we're working on getting formulary access at the moment.

所以，安德魯，正如你想像的那樣，我們目前正在努力獲得處方集的訪問權限。

We're working very hard on this.

我們正在為此努力工作。

We've had a lot of meetings with the different plans.

我們就不同的計劃舉行了很多會議。

We don't anticipate any issue there.

我們預計那裡不會出現任何問題。

We believe that in fact, the fact that there is an alternative to the 1 product that is in that class today will be accepted and welcomed by the different plans.

我們相信，事實上，今天該類別中的 1 產品有替代品這一事實將被不同的計劃所接受和歡迎。

Richard, on Humira.

理查德，修美樂。

Hi, Andrew, thank you for the question.

嗨，安德魯，謝謝你的提問。

Yes, we're very excited about the filing of adalimumab, along with Rituxan and the recent news.

是的，我們對阿達木單抗的申請以及 Rituxan 和最近的新聞感到非常興奮。

And also, then of rituximab in the EU we've got a real portfolio coming through here now.

而且，然後是歐盟的利妥昔單抗，我們現在已經有了一個真正的產品組合。

With regard to the legal strategy around many of these molecules, obviously, it's probably no surprise that we're not going to divulge that and talk about that.

關於圍繞這些分子中的許多分子的法律策略，顯然，我們不會洩露和談論它可能並不奇怪。

But the fact that we filed and we're moving forward this shows we are very confident about bringing this to market.

但我們提交並正在推進這一事實表明我們對將其推向市場非常有信心。

Andrew, on pricing in general, you're right in that outcomes-based pricing is taking kind of a slow start just because there are data barriers.

安德魯，關於一般定價，你是對的，因為存在數據障礙，基於結果的定價起步緩慢。

There are organizational barriers.

存在組織障礙。

There're regulatory barriers.

存在監管障礙。

But we are making some progress with these contracts.

但我們在這些合同方面取得了一些進展。

So we've seen a number of -- the number of contracts increase.

所以我們看到了一些——合同數量增加了。

They are relatively crude at this point but if you applied it to CAR-T, it's too early for us talk about pricing because this is a critical decision that we're going to make.

它們在這一點上相對粗糙，但如果你將它應用於 CAR-T，我們現在談論定價還為時過早，因為這是我們將要做出的關鍵決定。

You've probably seen the NHS evaluation of cell therapy and coming out above 750,000.

您可能已經看到 NHS 對細胞療法的評估結果超過 750,000。

So we're taking a very hard look at the value that this medicine delivers, the potential curative effect or at least durable response effect.

因此，我們正在非常認真地研究這種藥物提供的價值、潛在的療效或至少是持久的反應效果。

And you can imagine that we are trying to include some level of outcome ability on this kind of a pricing structure given that these are going to be expensive therapies.

你可以想像，我們正試圖在這種定價結構中包含某種程度的結果能力，因為這些將是昂貴的療法。

Bruno, do you have anything to add on that?

布魯諾，你有什麼要補充的嗎？

I think we are assessing as you said, Joe, multiple health economics models and outcome.

喬，我認為我們正在評估多種健康經濟學模型和結果。

And we'll be in a position to communicate at the time when we launch, which given the status of where we are, it should be imminent in the latter part of the year.

我們將在啟動時進行溝通，考慮到我們的現狀，它應該在今年下半年迫在眉睫。

Thanks, Andrew.

謝謝，安德魯。

Next question, please?

請問下一個問題？

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

下一個問題來自美銀美林的 Graham Parry。

So a few on BAF actually.

實際上，BAF 上有一些。

Can you just give us your confidence in obtaining an approval in relapsing MS given that in that indication specifically, you've only got the Phase II BOLD study and I think at the dose which was in the EXPAND study, there's only 50 patients there.

你能否給我們你獲得複發 MS 批准的信心，特別是在那個適應症中，你只有 II 期 BOLD 研究，我認為在 EXPAND 研究中的劑量下，那裡只有 50 名患者。

Or is the FDA looking at redefining your SPMS population as some sort of advance relapsing population that would actually support your relapsing indication?

或者 FDA 是否正在考慮將您的 SPMS 人群重新定義為某種實際上支持您的複發適應症的晚期復發人群？

Secondly, with the EXPAND data on the label, what sort of communication do you think you could then have with physicians on SPMS?

其次，有了標籤上的 EXPAND 數據，您認為您可以通過 SPMS 與醫生進行什麼樣的溝通？

Again, would these be redefined as some sort of relapsing type patients?

同樣，這些會被重新定義為某種複髮型患者嗎？

And then thirdly, on Afinitor, could you just comment on the patent protection and your best guess on expected generic launches now following the invalidation of the '772 patent that expired in March 2020 on the Certican litigation?

第三，關於 Afinitor，您能否就專利保護髮表評論，以及在 2020 年 3 月因 Certican 訴訟而到期的 '772 專利無效後，您對預期仿製藥上市的最佳猜測？

Do you expect any extra protection from the orphan drug exclusivities that you have on that product, for example?

例如，您是否希望從您對該產品的孤兒藥專有權中獲得任何額外保護？

And then finally, on RTH258.

最後，在 RTH258 上。

What do you actually need to see from the data in order to back the cost of the full U.S. launch of that product and also to try and drive a switch from Lucentis in Europe.

您實際上需要從數據中看到什麼，才能支持在美國全面推出該產品的成本，並嘗試在歐洲推動從 Lucentis 的轉變。

Essentially, do you need to see quarterly dosing with non-inferior efficacy or would you be happy to back a launch with just the every 2-month dosing?

從本質上講，您是否需要看到非劣效的季度劑量，或者您是否願意僅以每 2 個月的劑量來支持上市？

Okay, Vas on that?

好的，瓦斯？

So just to take a step back on relapsing MS and -- secondary progressive MS, so this is a continuum.

所以只是退後一步關於復發性 MS 和 - 二次進展性 MS，所以這是一個連續體。

And when you talk to most experts in the field, they'll tell you the BAF patients progress in relapsing MS. They'll eventually get to a stage where they will be in secondary progressive MS where they have fewer relapses or the relapses are much further apart.

當您與該領域的大多數專家交談時，他們會告訴您 BAF 患者在復發 MS 方面取得的進展。他們最終將進入二次進展型 MS 的階段，他們的複發次數較少或複發間隔更遠。

They have a higher EDSS score.

他們有更高的 EDSS 分數。

They're typically older because they've had MS for a longer periods of time.

他們通常年齡較大，因為他們患 MS 的時間較長。

So this is a continuum that we're talking about.

所以這是我們正在談論的連續統一體。

So in our discussions with FDA, what was clear is that our EXPAND study is a study of SPMS, which is a subset of patients who have relapsing MS. They're the ones who have progressed.

因此，在我們與 FDA 的討論中，很明顯我們的 EXPAND 研究是一項針對 SPMS 的研究，SPMS 是複發性 MS 患者的一個子集。他們是進步的人。

So our agreement that in the discussions we've had is to take our Phase II RMS study, along with our EXPAND study as a package that then we would take forward.

因此，我們同意在討論中將我們的 II 期 RMS 研究與我們的 EXPAND 研究作為一個整體進行，然後我們將繼續推進。

Now I will finally characterize the unique population that we studied in EXPAND, as I said, will be a discussion we'll have with the FDA, and we will propose labeling in the clinical section as well as in the indication section to reflect that.

現在我將最終描述我們在 EXPAND 中研究的獨特人群，正如我所說，這將是我們將與 FDA 進行的討論，我們將建議在臨床部分和適應症部分中進行標籤以反映這一點。

On Afinitor, Bruno.

關於 Afinitor，布魯諾。

So we've taken note of the recent court decision regarding the compound patent for Afinitor in U.S. and we will appeal that decision.

因此，我們注意到最近法院關於 Afinitor 在美國的化合物專利的判決，我們將對該判決提出上訴。

It's worth noting, though, there are 4 additional later expiring methods of treatment patents for Afinitor, which have expiration dates from the earliest in August 2022 and the latest in 2028.

不過值得注意的是，Afinitor 還有 4 項較晚到期的治療方法專利，其到期日期最早為 2022 年 8 月，最晚為 2028 年。

Currently, a generic version of Afinitor, assuming approval, cannot enter the market even at risk until expiration of the 30-month stay, and this stay, of course, varies for each of the ANDA filers.

目前，Afinitor 的仿製藥，假設獲得批准，即使有風險也不能進入市場，直到 30 個月的停留期滿，當然，這個停留期因每個 ANDA 申報者而異。

In that context, we do not currently see a need to change our previous assessments.

在這種情況下，我們目前認為沒有必要改變我們之前的評估。

And Paul on RTH.

保羅在 RTH。

Just a couple things on RTH, generally.

一般來說，RTH 上只有幾件事。

But I'll just make a comment on SPMS that was asked about.

但我只會對被問及的 SPMS 發表評論。

I think this is a short answer but we will look very specifically at the language once we have it from the regulator.

我認為這是一個簡短的回答，但一旦我們從監管機構那裡得到它，我們將非常具體地研究它。

It's clear there is a group of patients that are moving along the continuum and depending on that language and depending on the conversation with the regulator, we'll play our part in making sure they get the right treatment.

很明顯，有一群患者正在沿著連續統一體移動，並根據語言和與監管機構的對話，我們將發揮我們的作用，確保他們得到正確的治療。

As for RTH, rather not go into strategy yet and where we stand, but I think it's fair to say that we are set up for -- to look clearly at interval.

至於 RTH，而不是進入戰略和我們的立場，但我認為可以公平地說，我們已經準備好 - 清楚地觀察間隔。

And if we demonstrate the efficacy we expect, then we could be well-placed in the market.

如果我們展示了我們預期的功效，那麼我們就可以在市場上佔據一席之地。

Next question, please.

請下一個問題。

The next question comes from the line of Tim Anderson from Bernstein.

下一個問題來自伯恩斯坦的蒂姆安德森。

A couple of questions, please.

請問幾個問題。

If you were to dispose of Alcon, it would seem dilutive to earnings under many scenarios, and I'm wondering how you would likely offset or eliminate that dilution.

如果你要處置愛爾康，在許多情況下它似乎會稀釋收益，我想知道你將如何抵消或消除這種稀釋。

It would seem that M&A would be the most likely option.

併購似乎是最有可能的選擇。

And related to this topic, a lot of investors continue to think you might end up doing a large transaction.

與這個話題相關，很多投資者繼續認為你最終可能會進行大筆交易。

I generally hear you seem to say, you're really looking at bolt-ons.

我通常聽到你似乎在說，你真的在看螺栓固定裝置。

Can you update us on whether there's an upper limit to the size of the transactions you're potentially considering?

您能告訴我們您可能考慮的交易規模是否有上限嗎？

And second question is on Entresto.

第二個問題是關於 Entresto 的。

We held a conference a couple of months back primarily looking at payer issues.

幾個月前，我們召開了一次會議，主要討論付款人問題。

Express Scripts was one of the presenters.

Express Scripts 是主持人之一。

When we asked them their opinion about Entresto, they said they thought you priced it too low, which very much caught me by surprise.

當我們詢問他們對 Entresto 的看法時，他們說他們認為你們定價太低了，這讓我非常驚訝。

With the guidelines in place as of first half of last year, which you didn't have at the time of launch, I'm wondering if you feel you have significant upward pricing flexibility on this product in the U.S. And can you remind us how the pricing in the U.S. compares to European pricing?

根據去年上半年的指導方針，你在推出時還沒有，我想知道你是否覺得你在美國對該產品有很大的向上定價靈活性，你能提醒我們如何美國的定價與歐洲的定價相比？

Okay, thanks, Tim.

好的，謝謝，蒂姆。

Starting with the Alcon situation.

從愛爾康的情況開始。

As we said earlier, that review is underway.

正如我們之前所說，審查正在進行中。

Let's assume that we did exit and we had talked about potentially a capital market's exit.

讓我們假設我們確實退出了，並且我們已經討論過可能退出資本市場。

So I'm not as worried from a dilution standpoint.

所以從稀釋的角度來看，我並不那麼擔心。

Were we to spin this business off to our shareholders, from a total shareholder standpoint, you'd own a chunk of Novartis, you'd own a chunk of Alcon and presumably that would be a very nice couple of assets to own.

如果我們將這項業務分拆給我們的股東，從全體股東的角度來看，你將擁有諾華的一大塊股份，你將擁有愛爾康的一大塊股份，並且大概這將是非常好的資產。

So that's really at least the way that I'm thinking about it at this point.

所以這至少是我現在考慮的方式。

We did say that from an M&A standpoint, our sweet spot is bolt-ons for the 4 units, anywhere from $2 billion to $5 billion.

我們確實說過，從併購的角度來看，我們的最佳選擇是對這 4 個單位進行補強，價值從 20 億美元到 50 億美元不等。

We're having a hard time finding value-generating acquisitions even in that range just because prices have moved up quite a bit, and we're holding quite a disciplined financial hurdle to overcome before we're going to make even a move at $5 billion level.

即使在這個範圍內，我們也很難找到產生價值的收購，因為價格已經上漲了很多，而且在我們以 5 美元的價格上漲之前，我們要克服相當嚴格的財務障礙億元級別。

And so what you've seen us do is you've seen us move upstream a bit in the fourth quarter.

所以你看到我們所做的就是你看到我們在第四季度向上游移動了一點。

These are nice assets that are supplementing our pipeline.

這些都是很好的資產，可以補充我們的管道。

We're structuring them in a way that somewhat share the risk given that they're earlier stage assets, but we're finding that we can create a significant amount of additional value that way.

鑑於它們是早期資產，我們正在以某種方式分擔風險的方式構建它們，但我們發現我們可以通過這種方式創造大量的附加價值。

Paul, on Entresto?

保羅，關於 Entresto？

So an interesting question indeed on price.

所以確實是一個關於價格的有趣問題。

I think we should just look at some of the dynamics in the market.

我認為我們應該看看市場上的一些動態。

We have a strong, I say, support for the value for Entresto in the U.S. and the value that it brings to patients and to good use of the health care dollar.

我說，我們強烈支持 Entresto 在美國的價值及其為患者帶來的價值以及對醫療保健美元的良好利用。

Whilst we'll be vigilant on what that price and how it evolves over the coming year or 2, I think we've been seen by prescribers and payers and providers as behaving responsibly, and really, there was no pricing limitation to the uptake in volume.

雖然我們會密切關注該價格及其在未來一兩年的演變情況，但我認為開處方者、付款人和提供者認為我們的行為是負責任的，而且實際上，對吸收的定價沒有限制體積。

I think most importantly at this stage in the medicines launch, is trying to make sure that the clinical choice is the first choice, and we're creating the right environment for that to happen.

我認為在藥物推出的這個階段最重要的是，努力確保臨床選擇是首選，我們正在為實現這一目標創造合適的環境。

So we're pleased with the value we bring to the health care system.

因此，我們對我們為醫療保健系統帶來的價值感到滿意。

And just for information, on last question I think, we're roughly 2 to 1 in price U.S. versus Europe.

僅供參考，關於最後一個問題，我認為美國與歐洲的價格大約是 2 比 1。

Next question, please?

請問下一個問題？

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

下一個問題來自法國興業銀行的 Florent Cespedes 系列。

Three quick ones.

三個快速的。

First, for Paul, a follow-up on Entresto, could we have an update on the market access in the U.S. and ultimately, the proportion of patients without prior authorization in commercial and Medicare, like what you provided during your Investor Day?

首先，對於 Paul，Entresto 的後續行動，我們能否了解美國市場准入的最新情況，以及最終未經商業和醫療保險事先授權的患者比例，就像您在投資者日提供的那樣？

Second question for Bruno, could you share with us the first feedback from doctors in the U.S. following the launch of the product earlier than expected?

Bruno 的第二個問題，您能否與我們分享產品早於預期推出後美國醫生的第一批反饋？

And with $1 billion sales for the consensus in 2021 looks a bit conservative given the size of the market.

考慮到市場規模，2021 年 10 億美元的銷售額看起來有點保守。

So what the consensus is missing?

那麼缺少什麼共識呢？

And the last question is for Richard on rituximab in Europe following the positive recommendation, could you elaborate a bit on how do you see the product and the adoption of this product in different countries?

最後一個問題是理查德在積極推薦後在歐洲使用利妥昔單抗，您能否詳細說明一下您如何看待該產品以及該產品在不同國家/地區的採用情況？

And regarding -- a follow-up on Sandoz operating profit margin following this Q1.

關於 - 第一季度之後 Sandoz 營業利潤率的後續行動。

Is it a fair assumption to believe that this year, without Glatopa 40 milligrams, the operating profit margin of the division will be lower versus last year?

假設今年沒有 Glatopa 40 毫克，該部門的營業利潤率將低於去年，這是否合理？

Okay, Paul, Entresto?

好的，保羅，Entresto？

So on Entresto and Medicare, we've definitely made progress.

因此，在 Entresto 和 Medicare 方面，我們確實取得了進展。

We've moved from, I think, 25% with no prior auth to 33% over the quarter.

我認為，在本季度，我們已經從 25% 沒有事先授權的情況增加到 33%。

We do expect that to continue over the year.

我們確實希望這種情況會持續一年。

I'll repeat, I think we have enough access already to deliver on the commitment of approximately $500 million this year.

我再說一遍，我認為我們已經有足夠的機會來兌現今年約 5 億美元的承諾。

So for commercial, access has improved again, I think mid- to high single digit since what I reported at Q4.

因此，對於商業而言，訪問再次得到改善，我認為自我在第四季度報告以來是中高個位數。

Yes, approaching 50% no prior authorization.

是的，接近 50% 沒有事先授權。

Bruno, on Kisqali?

布魯諾，在基斯卡利？

So Florent, on the initial feedback that we're receiving from the medical community is very positive actually, particularly on the efficacy.

所以弗洛倫特，我們從醫學界收到的初步反饋實際上是非常積極的，尤其是在療效方面。

The physicians appreciate the fact that we reached primary endpoint at the interim analysis and the over 25-month PFS.

醫生們讚賞我們在中期分析和超過 25 個月的 PFS 中達到了主要終點。

The rapid response that Vas mentioned during his presentation is also a factor which is very important, and the fact that 3 out of the 4 patients see a tumor reduction at 8 weeks is perceived as being a very important factor.

Vas 在他的演講中提到的快速反應也是一個非常重要的因素，而且 4 名患者中有 3 名在 8 週時看到腫瘤縮小這一事實被認為是一個非常重要的因素。

Convenient dosing and the support programs that we've put in place are also seen as a differentiating factor versus the competition.

方便的劑量和我們已經實施的支持計劃也被視為與競爭對手相比的差異化因素。

And as Vas mentioned, the side effect profiles are very manageable and are not considered to be an issue.

正如 Vas 所提到的，副作用是非常易於管理的，不被認為是一個問題。

With regards to the forecast for the future, I mean, by all accounts, all analysts predict that this market is going to be in the range of $10 billion and perhaps even more, and we believe that we have a strong asset.

關於對未來的預測，我的意思是，從各方面來看，所有分析師都預測這個市場將在 100 億美元甚至更多的範圍內，我們相信我們擁有強大的資產。

We believe that with the legacy that we have in this field but also the programs that we have for the future, we have a very strong presence and that we will have a very competitive asset and certainly, that it will be a blockbuster.

我們相信，憑藉我們在該領域的傳統以及我們為未來製定的計劃，我們擁有非常強大的影響力，我們將擁有極具競爭力的資產，當然，這將成為重磅炸彈。

And the only thing that I'd add to that is, I think one of the reasons why consensus is where it is in '21 is that there is a lot of attention by the market to the safety profile of the drug.

我唯一要補充的是，我認為達成共識的原因之一是它在 21 世紀的位置是市場對該藥物的安全性非常關注。

So that's really going to be the key.

所以這真的是關鍵。

We believe and the early feedback is that the safety profile is manageable.

我們相信並且早期的反饋是安全狀況是可控的。

If it is, it's going to be a big drug.

如果是的話，那就是大藥了。

If it's not, then consensus might be closer to right.

如果不是，那麼共識可能更接近正確。

So Richard, on rituximab?

那麼理查德，在利妥昔單抗？

Yes, on rituximab.

是的，在利妥昔單抗上。

So obviously, looking forward to the launch of this and I think your question was around the adoption of this product.

很明顯，期待這個產品的推出，我認為你的問題是關於這個產品的採用。

Now as you've probably seen across the different biosimilars that have been launched, penetration is improving and is becoming quite rapid.

現在，正如您可能已經看到的那樣，已經推出了不同的生物仿製藥，滲透率正在提高並且變得非常快。

That said, when it comes to introducing a new biosimilar like rituximab, the market is often a different archetype.

也就是說，當談到引入像利妥昔單抗這樣的新生物仿製藥時，市場通常是不同的原型。

And so whether this is a tender market or a physician-led market, we have to consider that.

因此，無論這是招標市場還是醫生主導的市場，我們都必須考慮這一點。

And obviously we are going to have to get on formularies if it is a physician-led market and speak to physicians, and if it's a tender, it's the timing of those tenders.

顯然，如果這是一個由醫生主導的市場並與醫生交談，我們將不得不進入處方集，如果是招標，那就是這些招標的時間。

So I'd say, excited about it, but obviously with those things ahead of us, we have to get through those in the first 6 months to start the trajectory after that.

所以我會說，對此感到興奮，但顯然我們前面有這些事情，我們必須在前 6 個月內完成這些事情才能開始之後的軌跡。

And Richard, on profit margin?

理查德，關於利潤率？

And on profit margin, you talked about the 40 milligrams, the 40 milligrams obviously was built into our forecast, and as Harry mentioned, we have taken that out of our forecast.

關於利潤率，你談到了 40 毫克，這 40 毫克顯然是我們的預測，正如哈利提到的，我們已經將其從我們的預測中剔除。

So in recent years, you've seen some really good margin growth from Sandoz.

所以近年來，你已經看到 Sandoz 的利潤率增長非常好。

We don't give forecast on margin moving forward.

我們不對未來的利潤率做出預測。

I'd just say take into account that we're investing in our biosimilars both in Europe, which we just discussed and looking forward to some launches in the U.S. So I'd take that into account when modeling going forward.

我只想說考慮到我們正在歐洲投資我們的生物仿製藥，我們剛剛討論過並期待在美國推出一些產品，所以我會在未來建模時考慮到這一點。

Next question, please.

請下一個問題。

The next question comes from the line of Michael Leuchten from UBS.

下一個問題來自瑞銀的 Michael Leuchten。

A couple of questions on innovation -- Innovative Medicines, please.

關於創新的幾個問題——請問創新藥物。

SEG101 and BAF, I guess for Vas, the comments about the PK/PD data that is required for submission.

SEG101 和 BAF，我想對於 Vas，關於提交所需的 PK/PD 數據的評論。

The timing of that is a little bit unusual.

這樣做的時機有點不尋常。

So I was wondering if I could press you on that?

所以我想知道我是否可以就此向您施壓？

And similarly on BAF to manufacturing comments, again, unusual to have that as an open question after Phase III trial is finished.

同樣，在 BAF 上與製造評論類似，在 III 期試驗完成後將其作為一個懸而未決的問題也是不尋常的。

So I was just wondering whether you could add a bit of color on those 2?

所以我只是想知道你是否可以在這 2 個上添加一些顏色？

And then just going back to the question earlier on Gilenya, in terms of your response, value and volume declines.

然後回到之前關於 Gilenya 的問題，就你的回答、價值和數量下降而言。

I guess, it is very relevant given your filings strategy for BAF312.

我想，鑑於您的 BAF312 申請策略，這非常相關。

So what exactly has changed in the market dynamics that's taken the volume trends down as well as the pricing levels because it's not only you, I think the Tecfidera Q1 revenues were also below expectations relative to market.

那麼，市場動態究竟發生了什麼變化，導致銷量趨勢和定價水平下降，因為不僅是你，我認為 Tecfidera Q1 的收入也低於市場預期。

Okay, Vas?

好的，瓦斯？

So when you look at SEG101, we acquired this asset in December and then we had to go through the process of transferring the manufacturing and then upscaling to a final manufacturing process.

所以當你看 SEG101 時，我們在 12 月收購了這項資產，然後我們不得不經歷轉移製造的過程，然後升級到最終的製造過程。

You have to remember this was a small biotech that was developing this product.

你必須記住，這是一家正在開發該產品的小型生物技術公司。

So based on that, as soon as we have material available, we will then do a standard PK bridging study which FDA often requires when you move into final manufacturing for a biologic.

因此，基於此，一旦我們有可用的材料，我們將進行標準的 PK 橋接研究，當您進入生物製劑的最終製造階段時，FDA 通常會要求進行該研究。

And then based on the timeline for the readout of that study, we will file.

然後根據該研究的讀出時間表，我們將提交。

So I think there's nothing abnormal about the SEG101.

所以我覺得SEG101沒有什麼異常。

I mean, what's the -- the interesting thing is that we've been able to accelerate the filing from 2020 to 2018 based on a single Phase IIb study, which tells you given the New England Journal of Medicine publication and the confidence of FDA that this is an important medicine for an important unmet need with a strong profile.

我的意思是，有趣的是，我們已經能夠根據一項 IIb 期研究將申請從 2020 年加速到 2018 年，該研究告訴你，鑑於新英格蘭醫學雜誌的出版物和 FDA 的信心這是一種重要的未滿足需求的重要藥物，具有很強的知名度。

And with respect to BAF, I think we were of course waiting for the final results of the EXPAND study before significantly investing in manufacturing and getting the additional stability work done on the final manufacturing process.

關於 BAF，我認為我們當然是在等待 EXPAND 研究的最終結果，然後再對製造進行重大投資並在最終製造過程中完成額外的穩定性工作。

Now that we've got the results in hand, this is a more complex manufacturing process than you typically see in a small molecule.

現在我們已經掌握了結果，這是一個比您通常在小分子中看到的更複雜的製造過程。

So this isn't your traditional.

所以這不是你的傳統。

There are a few steps in the chemical synthesis that are unique and so we just have to get those finalized and get the batches and stability in place and then we'll be able to file in the first part of next year.

化學合成中有幾個獨特的步驟，所以我們只需要完成這些步驟並確定批次和穩定性，然後我們就可以在明年上半年提交文件。

And Paul, on Gilenya?

保羅，在 Gilenya？

Well, not much to add, other than what was said earlier.

好吧，除了前面所說的以外，沒有太多要補充的了。

Again, our share has held, overall we're up.

同樣，我們的份額保持不變，總體而言我們上漲了。

This decline in the market in both volume and value's been over the last sort of 3, 4 quarters.

在過去的 3、4 個季度中，市場的數量和價值都出現了下降。

It's not a recent phenomenon.

這不是最近的現象。

I think that's important also, and I think there is a -- this decline in the older injectables that has taken some of the volume and perhaps has increased rebating.

我認為這也很重要，而且我認為舊注射劑的這種下降已經佔據了一些數量並且可能增加了回扣。

We're, of course, as you would expect doing our own diligence just to confirm.

當然，正如您所期望的那樣，我們會儘自己的努力來確認。

But again, we're reasonably well-placed, and with BAF to follow on and with the recent deal with Amgen, we feel very good about our commitment to neurology and the team that's in play.

但同樣，我們處於相當有利的位置，隨著 BAF 的繼續以及最近與 Amgen 的交易，我們對我們對神經病學的承諾和參與其中的團隊感到非常滿意。

Thanks Paul.

謝謝保羅。

Next question, please.

請下一個問題。

The next question comes from the line of Vincent Meunier from Morgan Stanley.

下一個問題來自摩根士丹利的 Vincent Meunier。

The first one is on Cosentyx.

第一個在 Cosentyx 上。

How do you think you can accelerate in PsA?

你認為你可以如何加速 PsA？

And do you think that the 3 years efficacy data is enough or do you think you need to get the results of the head-to-head study versus Humira?

您認為 3 年的療效數據是否足夠，或者您是否認為您需要獲得與 Humira 的頭對頭研究的結果？

The second question is on NASH.

第二個問題是關於 NASH 的。

What is your approach regarding the patient selection?

您在患者選擇方面的方法是什麼？

And do you have non-invasive biomarkers for the different parameters you are studying?

您是否有針對您正在研究的不同參數的非侵入性生物標誌物？

Also, I have a question on Alcon.

另外，我有一個關於愛爾康的問題。

When should we expect the IOLs to be back to growth?

我們應該期望 IOL 何時恢復增長？

And also, what kind of margin pattern should we expect for Alcon after the 2017 trough?

此外，在 2017 年低谷之後，我們應該期待愛爾康的利潤率模式如何？

And the last question is on Entresto.

最後一個問題是關於 Entresto 的。

Can you confirm the target of $500 million sales this year?

你能確定今年5億美元的銷售額目標嗎？

And would it make sense for you to reconsider the size of the sales force in case you're unable to reach that target?

如果您無法達到該目標，重新考慮銷售人員的規模是否有意義？

Okay, Paul, first and last question?

好的，保羅，第一個也是最後一個問題？

Okay, so last question first.

好的，那麼最後一個問題。

I think on Entresto, our trend is good.

我認為在 Entresto 上，我們的趨勢是好的。

We're pleased with the quarter.

我們對本季度感到滿意。

We can see how that connects to the rest of the year.

我們可以看到這與今年剩餘時間有何联系。

Just to remind everybody that the global number of $500 million is definitely achievable.

只是提醒大家，全球5億美元的數字是絕對可以實現的。

Two things to bear in mind: one is the full deployment of the sales force in the U.S. happened at the beginning of the year and the true operational impact will come late summer, autumn.

有兩件事要牢記：一是美國銷售隊伍的全面部署發生在今年年初，真正的運營影響將在夏末秋季到來。

So we feel good about that progression.

因此，我們對這一進展感到滿意。

I think it's also worth adding, we've recently just come online in Italy and Canada reimbursed, and we'll get Entresto in France hopefully on the back end of the summer.

我認為這也值得補充，我們最近剛剛在意大利和加拿大上線報銷，我們有望在夏季末在法國獲得 Entresto。

And you may have missed the AMNOG approval for Entresto in Germany.

您可能已經錯過了 Entresto 在德國的 AMNOG 批准。

And what's important beyond just the approval, by the way, is that it was considered to have no additional budgetary impact for prescribers.

順便說一句，除了批准之外，重要的是它被認為對處方者沒有額外的預算影響。

So it's a complete clinical freedom to prescribe Entresto in Germany and supported by AMNOG.

因此，在德國開出 Entresto 處方並得到 AMNOG 的支持是完全的臨床自由。

So there's a lot of reasons to believe the second half of the year acceleration, and we're comfortable with that.

所以有很多理由相信今年下半年會加速，我們對此感到滿意。

And in terms of resourcing choices, we'll see how we play out for the remainder of the year, look at what our trend is and then reflect on that as we exit 2017.

在資源選擇方面，我們將看看我們在今年剩餘時間裡的表現如何，看看我們的趨勢是什麼，然後在我們結束 2017 年時對此進行反思。

Cosentyx, maybe Vas can kick off.

Cosentyx，也許 Vas 可以開始。

So on Cosentyx, on PsA and AS, I mean, one of the most -- one of the important things to remember is the data we already have in hand, which is really one the first drugs to show such high levels of stopping radiographic progression, which is what you want in these patients.

所以在 Cosentyx 上，在 PsA 和 AS 上，我的意思是，最重要的事情之一——要記住的重要事情之一是我們已經掌握的數據，這確實是第一個顯示出如此高水平停止放射學進展的藥物，這就是您想要的這些患者。

We also have long-term follow-up data in PsA out to 3 years, and AS out to 2 years, again, with radiographic data, which is very unique, I think, relative to other marketed agents.

我們在 PsA 方面也有長達 3 年的長期隨訪數據，以及長達 2 年的 AS，同樣，還有射線照相數據，我認為，相對於其他上市代理人，這是非常獨特的。

So that's allowing, as Paul can comment on, very strong performance in the spondyloarthropathies.

因此，正如保羅所評論的那樣，這允許在脊柱關節病中表現非常出色。

Now we're moving forward in the head-to-head studies both in PsA and AS and we're continue to do a number of profiling studies to look at the impact of the IL-17A pathway.

現在，我們正在推進 PsA 和 AS 的頭對頭研究，我們將繼續進行大量分析研究，以了解 IL-17A 通路的影響。

In ankylosing spondylitis specifically, IL-17A is viewed as really the linchpin pathway of the disease.

特別是在強直性脊柱炎中，IL-17A 被視為該疾病的關鍵通路。

Go ahead.

前進。

Sorry, Joe.

對不起，喬。

So just to add on to that, performance ex U.S., including psoriatic arthritis, and spondyloarthropathies and psoriasis, has us the #1 biologic in this space on new patients in no less than Germany, France and Spain.

因此，除此之外，美國以外的表現，包括銀屑病關節炎、脊柱關節病和銀屑病，使我們在這個領域的新患者中排名第一，不亞於德國、法國和西班牙。

In the U.S., depending on the weeklies, which can be a bit volatile, we have been market leader against Humira and Enbrel in spondyloarthropathies.

在美國，根據可能有點波動的周刊，我們在脊柱關節病領域一直是 Humira 和 Enbrel 的市場領導者。

So in the rheumatology community for AS and PsA, we have a tremendously effective product and a very good side effect profile based on low-to-no immunogenicity.

因此，在 AS 和 PsA 的風濕病學界，我們擁有非常有效的產品和基於低免疫原性或無免疫原性的非常好的副作用。

So we're seeing, frankly, extraordinary adoption in these patient populations.

因此，坦率地說，我們在這些患者群體中看到了非凡的採用率。

So on NASH, we continue to explore all manner of speeding up to clinical trials because as u rightly pointed out, you do require a biopsy and confirmation of the NASH diagnosis.

因此，在 NASH 上，我們繼續探索各種加速臨床試驗的方式，因為正如您正確指出的那樣，您確實需要進行活檢並確認 NASH 診斷。

And then to date, the FDA has required in pivotal studies serial biopsies to ultimately confirm that you are impacting fibrosis or impacting the progression.

然後到目前為止，FDA 已要求在關鍵研究中進行系列活檢，以最終確認您正在影響纖維化或影響進展。

Our overall strategy is to focus on later stages of the diseases, whether that's patients who are cirrhotics that are compensated or decompensated, that are close to the transplant list or patients who are in the F2, F3.

我們的總體策略是關注疾病的後期階段，無論是代償期或失代償期的肝硬化患者，接近移植名單的患者，還是處於 F2、F3 的患者。

But it's clear in these patients and all of the data suggests that if a patient reaches F3 with fibrosis, in all likelihood, they will progress to the transplant list.

但在這些患者中很明顯，所有數據都表明，如果患者達到 F3 纖維化，他們很可能會進入移植名單。

So that's our key area of focus in NASH, and that's where we're taking these portfolio of medicines.

所以這是我們在 NASH 中的重點關注領域，也是我們採用這些藥物組合的地方。

We don't believe moving upstream and to patients who are much further away from the ultimate consequences of the disease will be a compelling case.

我們不認為向上游移動並接觸到距離疾病最終後果更遠的患者將是一個令人信服的案例。

Mike.

麥克風。

And with respect to IOL, as you recall that what I had said previously is a necessary condition to get them back to growth is to fix the supply and service issues.

關於人工晶狀體，正如你記得我之前所說的，要讓他們恢復增長的必要條件是解決供應和服務問題。

So I think we've done a really good job in addressing those issues.

所以我認為我們在解決這些問題方面做得非常好。

As I look at the end of the first quarter then, I see the best conditions we've had than in the last 2 years.

當我回顧第一季度末時，我看到了我們擁有的最好的條件，而不是過去兩年。

So we seem to be getting very well-stabilized on that.

所以我們似乎在這方面非常穩定。

That is allowing our sales representatives to get back to selling, and this again is extremely important because not only the selling to current accounts, which we're experiencing competitive invasion, but also to new accounts where they haven't been going for some period of time because candidly, they are too busy servicing existing accounts.

這讓我們的銷售代表能夠重新開始銷售，這又一次非常重要，因為不僅要向我們正在經歷競爭入侵的經常賬戶銷售，還要向他們已經有一段時間沒有去的新客戶銷售坦率地說，他們太忙於為現有帳戶提供服務。

So as I look forward then, there's new technology, as Joe outlined, coming into each of the marketplaces.

因此，正如我所期待的那樣，正如喬所概述的那樣，新技術將進入每個市場。

Each of the regions will have something new to talk about.

每個地區都會有新的話題要談。

So in the United States, it will be the new ReSTOR 2.5 toric lens and also the 3.0 lens.

所以在美國，它將是新的 ReSTOR 2.5 复曲面鏡片和 3.0 鏡片。

And I think there's a really important addition to our portfolio because when you look at our ReSTOR lenses, we've been taking some serious market share erosion there, and one of the reasons has been because we have not had a toric offering while our competitors have.

而且我認為我們的產品組合中有一個非常重要的補充，因為當您查看我們的 ReSTOR 鏡片時，我們在那裡的市場份額受到嚴重侵蝕，其中一個原因是因為我們沒有提供复曲面產品，而我們的競爭對手有。

So this will make it more of a competitive lens in the marketplace so our sales reps are getting out there and selling it now.

因此，這將使它在市場上更具競爭力，因此我們的銷售代表現在就開始銷售它。

I would also say that in the United States, there's opportunities to also expand the toric marketplace.

我還要說的是，在美國，也有機會擴大復曲面市場。

So we've taken steps, then, to move forward with patient education initiatives.

因此，我們已經採取措施推進患者教育計劃。

Because as the baby boomers hit into their 70s, which is prime cataract place, then you look at opportunities where they are going to not accept what their parents had.

因為當嬰兒潮一代進入 70 多歲時，這是白內障的主要發生地，然後你會看到他們將不接受他們父母所擁有的東西的機會。

They're going to be looking for something new and better.

他們將尋找新的更好的東西。

As we look internationally then, PanOptix in Europe and PanOptix Toric has just been approved, as Joe mentioned.

正如 Joe 提到的那樣，從國際上看，歐洲的 PanOptix 和 PanOptix Toric 剛剛獲得批准。

UltraSert across the world right now and other opportunities in Canada and Japan with PanOptix.

UltraSert 現在遍布全球，加拿大和日本也有 PanOptix 的其他機會。

So I feel very good about how we're moving forward here, and we will look to see the IOLs start to turn at some place in the future.

所以我對我們在這裡的進展感到非常滿意，我們將期待看到人工晶狀體在未來的某個地方開始轉向。

With respect to margin, 2017 we said was going to be the trough year.

關於利潤率，我們說 2017 年將是低谷年。

What we also said, as you look out, that we should be starting to move back into line with the industry, and the industry we described has being in the low to mid-20s in terms of margin.

正如您所看到的，我們還說過，我們應該開始重新與行業保持一致，而我們所描述的行業的利潤率一直處於 20 年代中期的低水平。

Next question, please.

請下一個問題。

The next question comes from the line of Richard Vosser from JPMorgan.

下一個問題來自摩根大通的 Richard Vosser。

Just a couple, please.

就幾個，請。

Just firstly, on Cosentyx and thinking about potential future competition from J&J with guselkumab, how do you see that playing out in terms of potentially expanding the market or being a threat to the IL-17s?

首先，關於 Cosentyx 並考慮強生與 guselkumab 的潛在未來競爭，您如何看待它在潛在擴大市場或對 IL-17 構成威脅方面的影響？

Also, would it be possible to quantify the rebate pressure you've seen for Cosentyx in the first quarter in the U.S?

此外，是否有可能量化您在美國第一季度看到的 Cosentyx 的回扣壓力？

And then just finally, just a follow-up on the Alcon question.

最後，只是對愛爾康問題的跟進。

Just thinking about the investment levels that we've seen in Q1 for Alcon, is that now a sort of peak level ahead of our Q4 bolus or should we still see a little bit more investment in the coming quarters?

想想我們在第一季度看到的愛爾康的投資水平，現在是我們第四季度推注之前的某種峰值水平，還是我們應該在未來幾個季度看到更多的投資？

Paul?

保羅？

Thank you, Richard.

謝謝你，理查德。

Let's see, on Cosentyx, Cosentyx sets a very high bar on efficacy and safety.

讓我們看看，在 Cosentyx 上，Cosentyx 在有效性和安全性上設置了非常高的標準。

I was at the EADV last year when the guselkumab data broke, and there was a lot of dermatologists saying to me that they thought it didn't raise it further.

去年 guselkumab 數據出現問題時，我正在參加 EADV，很多皮膚科醫生對我說，他們認為它沒有進一步提高。

We will see because it's good news for patients that we're all in that market and we're trying to raise awareness and bring new treatments forward.

我們會看到，因為這對患者來說是個好消息，我們都在那個市場，我們正在努力提高認識並推出新的治療方法。

But I think we're well-placed frankly, particularly as has been mentioned I think by Joe upfront, at the new data from us around disease modification and retaining efficacy over the long term.

但坦率地說，我認為我們處於有利地位，特別是正如我認為喬預先提到的那樣，在我們關於疾病緩解和長期保持療效的新數據中。

The other part, of course -- which again, we all get sort of bunched together.

當然，另一部分——同樣，我們都聚集在一起。

But don't forget that it will be probably 2020, 2021 before the new entrants have PsA and AS, and I think -- and maybe not at all, frankly, I don't know.

但不要忘記，新進入者可能會在 2020 年、2021 年擁有 PsA 和 AS，而且我認為——也許根本不會，坦率地說，我不知道。

But Joe highlighted the scale of the opportunity in both those indications, and I think they're going to be absolutely critical.

但 Joe 強調了這兩個跡像中機會的規模，我認為它們將是絕對關鍵的。

And to remind you even on the IL-17As, we are unique to have both of them at the moment.

並且即使在 IL-17A 上也要提醒您，我們目前擁有這兩種飛機是獨一無二的。

And probably we'll have AS, perhaps even to the back end of next year.

可能我們會有 AS，甚至可能到明年年底。

And as for rebates, I did say at the Q4 results that we'd be thoughtful about our rebating.

至於回扣，我確實在第四季度的結果中說過，我們會考慮我們的回扣。

I think that's reflected in our position as we go through Q1.

我認為這反映在我們通過第一季度的立場上。

I also reminded everybody that we would be thoughtful in Q1 and then continue to grow our volume to compensate and accelerate beyond that throughout remainder of the year, and I think again, we're well-placed for that.

我還提醒大家，我們會在第一季度深思熟慮，然後在今年餘下的時間裡繼續增加我們的數量以補償和加速超越這一點，我再次認為，我們已經做好了準備。

And Mike, on investment levels?

邁克，在投資水平上？

Yes, so with respect to investment levels then, we are going to continue to invest in 2017 to get the top line moving again.

是的，那麼就投資水平而言，我們將在 2017 年繼續投資以再次推動收入增長。

We're going to be investing in things like DTC.

我們將投資於 DTC 之類的東西。

I think if you've looked at our lenses, you've seen they have reacted very nicely to DTC.

我想如果您看過我們的鏡頭，就會發現它們對 DTC 的反應非常好。

The objective of course is to get consistent top line growth.

當然，目標是獲得一致的收入增長。

I think where we are right now is in a stabilization phase.

我認為我們現在處於穩定階段。

And so you'll see some volatility on the top line.

所以你會看到收入有些波動。

But from my standpoint, we need to continue this investment through 2017 to drive that top line forward.

但從我的角度來看，我們需要在 2017 年繼續這項投資，以推動這一收入增長。

Okay, next question, please.

好的，請下一個問題。

The next question comes from the line of Michael Leacock from MainFirst.

下一個問題來自 MainFirst 的 Michael Leacock。

Three quick ones, if I may.

三個快速的，如果可以的話。

Firstly, in pharma, I notice the gross margin was up 0.8 percentage points.

首先，在製藥行業，我注意到毛利率上升了 0.8 個百分點。

I wonder if you could talk about the drivers for that, especially given the high levels of price and generic erosion that we saw in the quarter.

我想知道你是否可以談談這方面的驅動因素，特別是考慮到我們在本季度看到的高價格和仿製藥侵蝕。

On Sandoz, the emerging markets, China seems to be slowing down.

在新興市場山德士，中國似乎正在放緩。

Can you give us some more color on that, particularly as I notice in Innovative Medicines, the EM markets were up strongly.

你能給我們更多的顏色嗎，特別是正如我在創新藥物中註意到的那樣，新興市場市場強勁上漲。

And finally, on Alcon, it's a rough question, can you comment at all on the margin trends between the Surgical and the Vision Care?

最後，關於愛爾康，這是一個粗略的問題，您能否對外科手術和視力保健之間的利潤率趨勢發表評論？

Paul?

保羅？

So just put simply, a significant part of our growth is coming from Cosentyx and Entresto where our margin is much more impressive.

簡而言之，我們增長的很大一部分來自 Cosentyx 和 Entresto，我們的利潤率更為可觀。

Harry, do you want to add anything?

哈利，你想補充什麼嗎？

Well, I think cost of goods or the quality gross margins are a bit volatile overall.

好吧，我認為商品成本或質量毛利率總體上有點波動。

But we see that the new products, which have also very high gross margins and our productivity programs, don't forget we have centralized manufacturing a year ago and we start to see some fruits of that, of course are contributing to offset basically the Gleevec part.

但我們看到新產品也有很高的毛利率和我們的生產力計劃，別忘了我們在一年前就進行了集中製造，我們開始看到其中的一些成果，當然這有助於基本上抵消格列衛部分。

Richard, on China?

理查德，關於中國？

Yes, thanks for the question.

是的，謝謝你的提問。

So on China, yes, you're quite right.

所以關於中國，是的，你是對的。

We have seen a slowdown in the business there.

我們已經看到那裡的業務放緩。

It's a fairly simple business really, driven by a couple of molecules.

這真的是一個相當簡單的業務，由幾個分子驅動。

We've seen a bit of pricing pressure as the Chinese health care system looks to curtail some of the expenditure.

隨著中國醫療保健系統希望削減部分支出，我們看到了一些定價壓力。

I don't see that being long term.

我不認為這是長期的。

I think you can get through that -- through this year and then drive that business back to growth.

我認為你可以度過難關——度過今年，然後推動該業務恢復增長。

I think if you talk about emerging markets, it's important to point out we got some very good growth, above 20% in Japan.

我想如果你談論新興市場，重要的是要指出我們有一些非常好的增長，在日本超過 20%。

We're driving good growth in Australia, in the Middle East, in Central and Eastern Europe as well as Africa.

我們正在推動澳大利亞、中東、中歐和東歐以及非洲的良好增長。

These are markets we're focused on because we see them as markets which can drive profitability over the long term.

這些是我們關注的市場，因為我們將它們視為可以推動長期盈利能力的市場。

And so we're pleased to see the performance we're getting from those markets.

因此，我們很高興看到我們從這些市場獲得的業績。

And on Alcon, we don't break out the margin between Vision Care and surgical.

在愛爾康，我們沒有打破視力保健和外科手術之間的差距。

So that's something that we don't disclose.

所以這是我們不會透露的事情。

Next question, please?

請問下一個問題？

The next question comes from the line of Marietta Miemietz.

下一個問題來自 Marietta Miemietz。

One tax rate question for Harry.

哈利的一個稅率問題。

Can you just give us a very rough feel for how material the impact of the U.S. Corporation tax regime that may be enforced at any moment in time, actually is on Novartis' structurally low group tax rate.

您能否給我們一個非常粗略的感覺，即可能隨時強制執行的美國公司稅制的影響實際上對諾華公司的結構性低集團稅率有多大影響。

Because Joe, you told President Trump, that lower taxes would help you, and I wasn't quite sure if you were just speaking on behalf of the industry in that meeting or if Novartis itself would actually benefit.

因為喬，你告訴特朗普總統，降低稅收會對你有幫助，我不太確定你在那次會議上只是代表行業發言，還是諾華公司本身真的會受益。

So any feel for the proportion of your U.S. profits that is actually taxed in the U.S. or any kind of sensitivity of your group tax rate to the average U.S. corporation tax rate would be really helpful.

因此，任何對您在美國實際徵稅的美國利潤的比例或您的集團稅率對美國公司平均稅率的任何敏感性的任何感覺都會非常有幫助。

And then one question for Richard, please.

然後有一個問題要問理查德。

Just following on from Florent's question.

緊接佛羅倫特的問題。

Can I infer from your answer that the reason you're expecting growth to taper for biosimilars later this year, despite the big launches coming up, is really entirely due to your ramp expectations, and you've not baked any deterioration in the overall pricing environment into your guidance?

我能否從你的回答中推斷出，儘管即將推出大型產品，但你預計今年晚些時候生物仿製藥的增長將逐漸放緩，這完全是由於你的增長預期，而且你沒有考慮到整體定價的任何惡化環境進入你的指導？

And maybe if you just could give us a very brief update on the market dynamics.

也許你能給我們一個非常簡短的市場動態更新。

In particular, whether sort of a 50% to 70% price discount in the U.S. to the originator and a 30% to 50% discount in Europe is really still how we should think about most of the assets in your pipeline?

特別是，美國對發起人的 50% 至 70% 的價格折扣和歐洲的 30% 至 50% 的折扣是否真的仍然是我們應該如何考慮您管道中的大部分資產？

And whether you feel that the development risk has increased in the last 6 to 12 months?

您是否覺得在過去 6 到 12 個月內開發風險增加了？

Or maybe asked a different way, when you see a competitor divesting a business in the biosimilars space for an upfront payment that is actually below the cash they plowed into it.

或者可能會以不同的方式問，當您看到競爭對手剝離生物仿製藥領域的業務以獲得實際低於他們投入的現金的預付款時。

Is that in your opinion consistent with changes in the commercial opportunity?

您認為這與商業機會的變化一致嗎？

Or are you puzzled, or would you say that, that sort of thing is really just down to fluke, be really helpful.

或者你不解，或者你會說，那種事情真的只是僥倖，真的很有幫助。

Okay.

好的。

Harry?

哈利？

Yes, thank you for your question on the U.S. tax reforms.

是的，謝謝你關於美國稅制改革的問題。

Of course, as we all know, none of these details are even completely mentioned or they start to be maybe debated.

當然，眾所周知，這些細節甚至都沒有被完全提及，或者可能開始引起爭論。

So I think tomorrow some further things will be disclosed.

所以我想明天會披露一些進一步的事情。

But until things will be finalized and this probably will take some time.

但在事情最終確定之前，這可能需要一些時間。

Now we are a significant taxpayer in the U.S. So the corporate tax rate reduction certainly would be a nice positive for us.

現在我們是美國的重要納稅人。因此，降低公司稅率對我們來說肯定是一個很好的積極因素。

At this moment, we don't model any positive going forward because we don't know all elements of it.

目前，我們沒有對任何積極的未來進行建模，因為我們不知道它的所有要素。

Now we have a lot of substance in the U.S., more than 22,000 people, [ 13 ] manufacturing sites, a lot -- more than 7,000 people in R&D and more than 7,000 in manufacturing, but what are the other elements, be it border adjustment tax and so on.

現在我們在美國有很多物質，超過 22,000 人，[13] 製造基地，很多 - 超過 7,000 人從事研發，超過 7,000 人從事製造，但其他因素是什麼，是邊界調整稅收等等。

So I think we just have to continue to monitor this and once things become clear, then, of course, you would comment on it in a more quantitative way.

所以我認為我們只需要繼續對此進行監控，一旦事情變得明朗，當然，你會以更量化的方式對其進行評論。

And Marietta, it was a Novartis-specific comment because we are big taxpayers in the U.S. So Richard, on biosimilars?

瑪麗埃塔，這是針對諾華的評論，因為我們是美國的納稅大戶。所以理查德，關於生物仿製藥？

Yes, if I understood the question correctly, it was the slowdown in growth that Joe mentioned this year -- excuse me, last half of this year.

是的，如果我對這個問題的理解正確的話，那是喬今年提到的增長放緩——對不起，今年下半年。

And that basically comes down to the fact that a significant amount of our growth was delivered last year by the good acceleration uptake of Zarxio in the U.S. and Glatopa 20 milligrams.

這基本上歸結為這樣一個事實，即去年我們的大量增長是由於 Zarxio 在美國和 Glatopa 20 毫克的良好加速吸收而實現的。

Although we see good growth in our business outside the U.S., across all of our portfolio, obviously, that growth was significant last year, as you know.

儘管我們看到我們在美國以外的業務增長良好，但在我們所有的投資組合中，顯然，如您所知，去年的增長非常顯著。

And as those launches start to mature, that's going to slow down towards the end of this year.

隨著這些發布開始成熟，到今年年底將放緩。

But obviously, we are hoping that as we see those files mature into launches in our portfolio, then that growth will obviously come back.

但顯然，我們希望當我們看到這些文件在我們的產品組合中成熟並發佈時，這種增長顯然會回來。

With regard to the pricing, I think you were saying is anything changed within the pricing environment with regard to how we look at it going forward, to what we said in the past.

關於定價，我想你說的是定價環境中關於我們如何看待它的未來以及我們過去所說的任何變化。

Not really.

並不真地。

Obviously, it depends sometimes on the archetype of the market, whether it's a pure tender market or it's a market that's driven by the physician.

顯然，這有時取決於市場的原型，是純粹的投標市場還是由醫生驅動的市場。

But I think what we've quoted in the past between 20% and 30% at the start still holds true, and that can obviously progress depending on the maturity of the market and the molecule.

但我認為我們過去一開始所引用的 20% 到 30% 之間的數據仍然適用，而且根據市場和分子的成熟度，這顯然會有所進展。

With regard to the development risk and the change with regard to people coming out of this business, it's very hard for me to comment on that, and I probably won't.

關於發展風險和從這個行業出來的人的變化，我很難評論，我可能不會。

What I'll say is (inaudible) ask about it and we've get a pipeline is we believe, as Joe has mentioned on a number of occasions that the health care system needs biosimilars.

我要說的是（聽不清）詢問它，我們相信我們已經有了一條管道，正如喬在許多場合提到的那樣，醫療保健系統需要生物仿製藥。

There's a very big value proposition.

有一個非常大的價值主張。

We think we have a great portfolio, a very good commercial and efficient commercial model.

我們認為我們有一個很好的投資組合，一個非常好的商業和高效的商業模式。

So we can see good returns on this for the considerable future.

因此，我們可以在可觀的未來看到良好的回報。

Yes, I think one of the things that you're seeing in terms of people pulling out is this isn't easy stuff.

是的，我認為你在人們退出方面看到的一件事是這不是一件容易的事。

This is difficult thing to do.

這是很難做到的事情。

It's also -- you've got to have scale.

這也是——你必須有規模。

So I think what you're seeing is at the end of the day, there's going to be a few big manufacturers of biosimilars.

所以我認為你所看到的是在一天結束時，將會有幾家大型生物仿製藥製造商。

I would also just comment on your pricing expectations.

我也只想評論您的定價預期。

I think the European assumption that you said was right.

我認為你說的歐洲假設是正確的。

But the market dynamics in the U.S. is probably a bit too aggressive.

但美國的市場動態可能有點過於激進。

I think you said 50% to 70%.

我想你說的是 50% 到 70%。

Remember we're not assuming a high level of automatic switch and actually, that's better for us because we're able to build a franchise over time selling on the similarity of this molecule relative to a more expensive molecule.

請記住，我們並沒有假設高水平的自動切換，實際上，這對我們來說更好，因為我們能夠隨著時間的推移建立特許經營權，銷售這種分子相對於更昂貴分子的相似性。

And the way that we're building our U.S. business is highly profitable because of that.

因此，我們建立美國業務的方式是高利潤的。

So we'll just leave it at that.

所以我們就此打住。

Next question, please.

請下一個問題。

The next question comes from the line of Kerry Holford from BNP Paribas.

下一個問題來自法國巴黎銀行的 Kerry Holford。

Three questions, please.

請教三個問題。

The first for Harry, just looking at the guidance for the year, the Innovative Medicines sales outlook has been raised marginally.

對於 Harry 來說，首先看一下今年的指導，創新藥物的銷售前景已經小幅上調。

I guess it's unusual to revise guidance at this stage of the year.

我想在今年的這個階段修改指南是不尋常的。

So I'm wondering if you can highlight specifically what's driving that more optimistic sales outlook for that division.

所以我想知道你是否可以具體強調是什麼推動了該部門更樂觀的銷售前景。

Secondly, on AMG 334, you're now co-promoting in the U.S. Do you envisage recruiting additional sales reps to promote that drug, or can you leverage your existing MS sales force to promote that product?

其次，關於 AMG 334，您現在正在美國共同推廣。您是否打算招募更多的銷售代表來推廣該藥物，或者您是否可以利用現有的 MS 銷售人員來推廣該產品？

I'm just trying to understand the likely incremental cost of launching that drug next year, potentially.

我只是想了解明年推出該藥物可能增加的成本。

And then last on biosimilars, just checking in on the U.S. filings for biosimilars Humira and Epogen.

最後是生物仿製藥，只需查看美國生物仿製藥 Humira 和 Epogen 的申請。

They were delayed last year owing to manufacturing inspections.

由於製造檢查，他們去年被推遲了。

I don't think they've yet been filed.

我認為他們還沒有被歸檔。

If I'm correct, why not and what's the continued delay there?

如果我是對的，為什麼不呢？那裡的持續延遲是什麼？

Harry?

哈利？

Yes, thank you.

是的，謝謝。

Yes, as you mentioned there's a slight increase in the guidance of Innovative Medicines.

是的，正如您提到的，創新藥物的指導略有增加。

I think it indicates you're probably at the upper end of the range of broadly in line due to a slight increase.

我認為這表明由於略有增加，您可能處於大致一致範圍的上限。

And the Innovative Medicines division has made a very solid start to the year with the quarter 1 plus 2% growth, driven by the Pharmaceutical business unit with plus 6%.

在製藥業務部門 6% 的推動下，創新藥物部門今年開局非常穩健，第一季度增長 2%。

So we simply see a stronger sales momentum and reduced downside risks in the Innovative Medicines division, and therefore, we made this small upgrade to the sales guidance.

因此，我們只是看到創新藥物部門的銷售勢頭更強勁，下行風險降低，因此，我們對銷售指引進行了小幅升級。

Okay, Paul, on Amgen?

好吧，保羅，關於安進？

So it's a little bit early to call exactly what will happen in terms of resourcing in the U.S. We're delighted to announce yesterday, as Vas mentioned, it's a significant unmet need, I think over 5 million migraine sufferers in the U.S. We are now working through what it takes to deploy.

因此，現在準確預測美國的資源配置情況還為時過早。我們昨天很高興地宣布，正如 Vas 提到的那樣，這是一個未滿足的重大需求，我認為美國有超過 500 萬偏頭痛患者。我們現在完成部署所需的工作。

And it was already mentioned earlier that we have a very impressive neurology sales force, and they'll be at the center of what we do.

前面已經提到我們有一支非常令人印象深刻的神經病學銷售隊伍，他們將成為我們工作的核心。

So clearly, there's some opportunity there.

很明顯，那裡有一些機會。

And then we'll resource accordingly to win in the market as the first entrant.

然後我們將相應地分配資源，以作為第一個進入者贏得市場。

And Vas?

還有瓦斯？

So in terms of U.S. biosimilars filings, we are on track across our filings with our monoclonal antibody.

因此，就美國生物仿製藥申請而言，我們的單克隆抗體申請正步入正軌。

So with Humira, we plan to file soon and will provide an update as soon as that file is accepted.

因此，對於 Humira，我們計劃盡快提交文件，並在該文件被接受後立即提供更新。

And we continue to be on track as well with our pegfilgrastim filing, which we expect to happen in the first part of 2018.

我們的 pegfilgrastim 申請也繼續走上正軌，我們預計將在 2018 年上半年完成。

With respect to Epo, we are continuing to evaluate some additional data that has come in and then once we'll fully evaluate that data will clarify our filing strategy on Epo.

關於 EPO，我們正在繼續評估一些額外的數據，一旦我們對這些數據進行全面評估，我們將闡明我們在 EPO 上的申請策略。

I think we have time for one final question.

我想我們還有時間問最後一個問題。

Yes, that's it, one final question.

是的，就是這樣，最後一個問題。

There are no further questions in the queue.

隊列中沒有其他問題。

Okay, listen, I want to thank everybody for tuning in and we look forward to giving up data at the half year.

好的，聽著，我要感謝大家的收聽，我們期待在半年內放棄數據。

Thank you.

謝謝。

Ladies and gentlemen, thank you for joining today's call.

女士們，先生們，感謝你們參加今天的電話會議。

You may now disconnect your handsets.

您現在可以斷開聽筒。