使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good morning and good afternoon. Welcome to the Novartis Q3 2016 results release conference call and live audio webcast.
早上好,下午好。歡迎來到諾華 2016 年第三季度業績發布電話會議和現場音頻網絡廣播。
(Operator Instructions)
(操作員說明)
The conference is being recorded.
會議正在錄製中。
(Operator Instructions)
(操作員說明)
A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends.
電話會議的錄音,包括問答環節,將在電話會議結束後不久發佈在我們的網站上。
(Operator Instructions)
(操作員說明)
With that, I would like to hand over to Mr. Joe Jimenez, CEO of Novartis. Please go ahead, sir.
有了這個,我想把它交給諾華公司的首席執行官喬·希門尼斯先生。請繼續,先生。
- CEO
- CEO
Thank you, I'd like to welcome everybody to our third-quarter earnings call. Joining me here at Novartis are Harry Kirsch, our CFO; Vas Narasimhan, the Global Head of Drug Development; Paul Hudson, Head of Pharma; Bruno Strigini, Head of Oncology; Richard Francis, Head of Sandoz; and Mike Ball, Head of the Alcon business. Before we start, I'd like Samir Shah to read the Safe Harbor statement.
謝謝大家,歡迎大家參加我們的第三季度財報電話會議。和我一起加入諾華的是我們的首席財務官 Harry Kirsch;藥物開發全球負責人 Vas Narasimhan; Paul Hudson,製藥部主管; Bruno Strigini,腫瘤學負責人; Sandoz 負責人 Richard Francis;和愛爾康業務負責人 Mike Ball。在我們開始之前,我希望 Samir Shah 閱讀安全港聲明。
- IR
- IR
Good morning and good afternoon, everybody. The information presented in this conference call contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors. These may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Please refer to the Company's Form 20-F on file with the US Securities and Exchange Commission for a description of some of these factors.
大家早上好,下午好。本次電話會議中提供的信息包含涉及已知和未知風險、不確定性和其他因素的前瞻性陳述。這些可能導致實際結果與此類陳述明示或暗示的任何未來結果、業績或成就存在重大差異。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。
- CEO
- CEO
Thanks, Samir. Starting on slide number 4, we had a solid quarter, taking into consideration the loss of Glivec. Our sales were down 1 point in constant currency, so broadly in line with prior year, due to strong performance of our growth products, which offset the Glivec patent expiration. Core operating income was down 3% in constant currency, reflecting that generic erosion, but also our investment in Cosentyx and Entresto launches, as well as the Alcon turn.
謝謝,薩米爾。從幻燈片 4 開始,考慮到 Glivec 的損失,我們有一個穩定的季度。由於我們增長產品的強勁表現抵消了 Glivec 專利到期,我們的銷售額按固定匯率計算下降了 1 個百分點,與上一年基本持平。按固定匯率計算,核心營業收入下降了 3%,反映了一般性侵蝕,但也反映了我們對 Cosentyx 和 Entresto 發布以及愛爾康的投資。
We had strong innovation, which we'll talk about in a minute, but on slide number 5, you can see that we had five key priorities in 2016, so let's start with the financial results. What impressed me about this quarter is really the strength of the growth products which offset the loss of Glivec in the US, so we had products such as Cosentyx and Gilenya, and the new oncology products, performing very well. This is really a testament to the strength of our innovation engine that's able to offset a patent exploration like Glivec.
我們有強大的創新,我們將在一分鐘內討論,但在第 5 張幻燈片上,您可以看到我們在 2016 年有五個關鍵優先事項,所以讓我們從財務結果開始。本季度給我留下深刻印象的是增長產品的實力,抵消了 Glivec 在美國的損失,因此我們的 Cosentyx 和 Gilenya 等產品以及新的腫瘤產品表現非常好。這確實證明了我們創新引擎的實力能夠抵消像格列衛這樣的專利探索。
Harry is going to talk about these drivers in more detail, but first I want to go through some of the key launches that are helping rejuvenate the portfolio, starting with Cosentyx on the next slide. Our strong launch continues in the third quarter. We shipped about $300 million in sales. We're on track to deliver blockbuster status by year-end.
Harry 將更詳細地討論這些驅動因素,但首先我想介紹一些有助於振興產品組合的關鍵發布,從下一張幻燈片中的 Cosentyx 開始。我們在第三季度繼續推出強勁產品。我們的銷售額約為 3 億美元。我們有望在年底前交付重磅炸彈。
This momentum is being supported by some new data this quarter. We published a head-to-head study showing that Cosentyx is superior to Stelara in adults with moderate to severe psoriasis, so this is turning out to be a very effective drug. Then second, we published data that showed the efficacy of the drug is sustained at four years. This also speaks to the impressive tolerability of Cosentyx.
這一勢頭得到本季度一些新數據的支持。我們發表了一項頭對頭研究,表明 Cosentyx 在患有中度至重度銀屑病的成人中優於 Stelara,因此事實證明這是一種非常有效的藥物。其次,我們公佈的數據顯示該藥物的療效可持續四年。這也說明了 Cosentyx 令人印象深刻的耐受性。
On the next slide, I wanted to show you some shares. While we recognize that psoriasis is becoming more competitive, and we're holding our own there, we are making great progress in some of the other indications. As you know, Cosentyx is the first anti-L17 to win approval in all three indications, including ankylosing spondylitis and psoriatic arthritis. We're driving continued share gains in those two new indications, already on par with Humira and Enbrel when it comes to NBRx share at about 27%.
在下一張幻燈片中,我想向您展示一些分享。雖然我們認識到銀屑病的競爭正變得越來越激烈,並且我們在那裡堅持自己的立場,但我們在其他一些適應症方面也取得了很大進展。如您所知,Cosentyx 是第一個在所有三種適應症(包括強直性脊柱炎和銀屑病關節炎)中都獲得批准的抗 L17。我們正在推動這兩個新適應症的份額持續增長,在 NBRx 份額方面已經與 Humira 和 Enbrel 持平,約為 27%。
On Entresto, everything that we're seeing continues to reinforces our belief in this drug. Sales grew steadily to $53 million in the quarter. We've got approvals in 64 countries. This quarter we had a new data analysis that continued to confirm the quality-of-life benefit of Entresto. We are learning this is becoming more and more important to physicians.
在 Entresto 上,我們所看到的一切都在繼續加強我們對這種藥物的信心。本季度銷售額穩步增長至 5300 萬美元。我們在 64 個國家/地區獲得了批准。本季度我們進行了一項新的數據分析,繼續證實 Entresto 對生活質量的益處。我們了解到這對醫生來說變得越來越重要。
In the US also, we're expanding our primary care field force. That's underway, as is the expansion of our medical education support. So these investments are leading to an acceleration of TRx for Entresto. US adoption continues to increase, and as a result, we expect sales to be in the range of $200 million for the full year 2016.
在美國,我們也在擴大我們的初級保健現場人員。這正在進行中,我們的醫學教育支持也在擴大。因此,這些投資正在加速 TRx for Entresto 的發展。美國的採用率繼續增加,因此,我們預計 2016 年全年的銷售額將在 2 億美元左右。
Biosimilars, on the next slide, is also a very strong growth story for us. We now have four biosimilars approved, we're on track for $1 billion in sales this year. 50% of that is coming from the US. So for example, Zarxio has had a good start and we have exceeded $100 million since launch. Glatopa has a 40% market share now, which is over $140 million year-to-date.
下一張幻燈片上的生物仿製藥對我們來說也是一個非常強勁的增長故事。我們現在有四種生物仿製藥獲得批准,我們今年的銷售額有望達到 10 億美元。其中 50% 來自美國。例如,Zarxio 有了一個良好的開端,自推出以來我們已經超過了 1 億美元。 Glatopa 現在擁有 40% 的市場份額,今年迄今已超過 1.4 億美元。
Moving on to the pipeline, we had a number of strong approvals and read-outs in Q3. Vas is going to go through this, but just to highlight, LEE011 demonstrated superior progression-free survival as a first-line treatment in advanced breast cancer. We also got FDA breakthrough therapy designation there.
繼續進行中,我們在第三季度獲得了許多強有力的批准和解讀。 Vas 將經歷這一過程,但要強調的是,LEE011 作為晚期乳腺癌的一線治療表現出卓越的無進展生存期。我們在那裡還獲得了 FDA 的突破性療法認定。
Then in neuroscience, BAF312 met its primary endpoint in secondary progressive MS. AMG 334 had a positive Phase III and Phase II read-out in both episodic and chronic migraine, respectively. And then at Sandoz, the FDA approved the first biosimilar of Etanercept. This is called Erelzi and it is for all indications.
然後在神經科學領域,BAF312 在繼發性進展性多發性硬化症中達到了其主要終點。 AMG 334 在發作性和慢性偏頭痛中分別具有陽性 III 期和 II 期讀數。然後在 Sandoz,FDA 批准了 Etanercept 的第一個生物仿製藥。這稱為 Erelzi,適用於所有適應症。
On slide 13, you can see that in cell and gene therapy, we continue to be committed to this technology. We're on track to file CTL019 in pediatric acute lymphoblastic leukemia. This will be in early 2017. We expect to file DLBCL in the second half of 2017.
在幻燈片 13 上,您可以看到在細胞和基因治療方面,我們繼續致力於這項技術。我們有望在小兒急性淋巴細胞白血病中提交 CTL019。這將是在 2017 年初。我們預計將在 2017 年下半年提交 DLBCL。
There was some speculation as to why we integrated this standalone unit into the functions at Novartis. This was done to give the unit the deep capabilities of drug development and global manufacturing, while at the same time, lowering overhead and costs as we start to prepare for the launch. So fully integration into the oncology unit will help also on the commercial side as we launch.
關於為什麼我們將這個獨立單元集成到諾華的功能中,有一些猜測。這樣做是為了讓該部門具備藥物開發和全球製造的深度能力,同時在我們開始準備上市時降低管理費用和成本。因此,在我們推出時,完全融入腫瘤部門也將有助於商業方面。
Alcon, on the next slide, although we were down in the quarter, we're seeing signs of progress in vision care. Specifically, contact lenses has seen a return to growth over the last two quarters, gaining share in European markets where we have added DTC investments. We also have the launch of DT1 Multifocal around the world, so this should build even more momentum for our contact lens business.
愛爾康,在下一張幻燈片中,儘管我們在本季度表現不佳,但我們看到了視力保健方面取得進展的跡象。具體而言,隱形眼鏡在過去兩個季度恢復增長,在我們增加 DTC 投資的歐洲市場獲得份額。我們還在全球推出了 DT1 Multifocal,因此這應該會為我們的隱形眼鏡業務帶來更多動力。
On the next slide, in surgical, I think we're taking the right actions to deliver sustainable growth in the longer-term. You saw some good innovation news in the third quarter. Beyond UltraSert and PanOptix, which we had announced earlier, we had approval to our CyPass Micro-Stent device -- this is for glaucoma -- and NGENUITY 3D Visualization system for vitreoretinal surgery, so there's a lot of news and a lot of innovation that is coming on the surgical side.
在下一張幻燈片中,我認為我們正在採取正確的行動來實現長期可持續增長。你在第三季度看到了一些好的創新消息。除了我們之前宣布的 UltraSert 和 PanOptix 之外,我們還批准了我們的 CyPass 微型支架設備——用於青光眼——和用於玻璃體視網膜手術的 NGENUITY 3D 可視化系統,所以有很多新聞和創新正在手術方面。
We are reinforcing our strong customer relationships. We have a new training system in place for our customers, more field service engineers, and clinical application specialists, which help the surgeons in their office.
我們正在加強我們牢固的客戶關係。我們為我們的客戶、更多的現場服務工程師和臨床應用專家建立了新的培訓系統,這可以幫助他們辦公室的外科醫生。
We're also returning or improving basic operations. So exiting Q3, we had very good customer supply levels and we're rolling out a new SAP system globally on that business. So even though we had a down quarter, I feel like we're doing what we need to do on surgical. It's taking a bit longer, but we're doing the right things on the business.
我們也在恢復或改進基本操作。因此,在第三季度結束時,我們的客戶供應水平非常好,我們正在全球範圍內針對該業務推出新的 SAP 系統。因此,即使我們有一個下滑的季度,我覺得我們正在做我們需要做的手術。這需要更長的時間,但我們正在做正確的事情。
The fourth objective is to drive cross-divisional synergies, and Novartis business services kept costs stable again this quarter versus year-ago. They did it by continuing to offshore certain positions to our five global service centers. Standardizing also infrastructure services at some manufacturing sites, and IT consolidation across countries, and across divisions is, we're finding, will generate significant savings.
第四個目標是推動跨部門協同,諾華商業服務本季度與去年同期相比再次保持成本穩定。他們通過繼續將某些職位離岸到我們的五個全球服務中心來做到這一點。我們發現,一些製造基地的基礎設施服務標準化,以及跨國家和跨部門的 IT 整合將產生顯著的節省。
And then finally, on our fifth objective, we continue to build a high-performing Organization, as we integrate some of our global functions across divisions. So for example, in manufacturing, we have started to integrate around technology platforms, and in global drug development, we're integrating the global functions. This work is well underway.
最後,關於我們的第五個目標,我們將跨部門整合我們的一些全球職能,繼續打造一個高績效組織。因此,例如,在製造業,我們已經開始圍繞技術平台進行整合,在全球藥物開發方面,我們正在整合全球職能。這項工作進展順利。
While it's going to take some time to see significant savings here, we're already seeing early benefits, such as improved transparency, which is enabling us to do better resource allocation faster. Also, we're seeing a more collaborative culture emerge in those functions and across divisions.
雖然需要一些時間才能看到顯著的節省,但我們已經看到了早期的好處,例如提高透明度,這使我們能夠更快地進行更好的資源分配。此外,我們還看到在這些職能和部門之間出現了一種更具協作性的文化。
Now I'm going to turn it over to Harry to take us through the financials in more detail. Harry?
現在我要把它交給哈里,讓我們更詳細地了解財務狀況。哈利?
- CFO
- CFO
Thank you, Joe. Good morning and good afternoon, everyone. On slide 19, you'll see a summary of our performance in quarter three. As a reminder, these numbers reflect our continuing operations and my comments will be, as always, focusing on growth rates in constant currencies unless otherwise noted.
謝謝你,喬。大家早上好,下午好。在幻燈片 19 上,您將看到我們在第三季度的業績摘要。提醒一下,這些數字反映了我們的持續運營,除非另有說明,否則我的評論將一如既往地關注固定貨幣的增長率。
We had a solid third quarter, with sales down 1%, broadly in line with prior-year, despite a full quarter of Glivec generic impact in the US, which included a couple of new entrants as of August. Core operating income was down 3%, mainly due to generic erosion and growth investments in Entresto, Cosentyx, and Alcon, partially offset by productivity improvements.
我們第三季度表現穩健,銷售額下降 1%,與上年同期基本持平,儘管 Glivec 仿製藥對美國產生了整整一個季度的影響,其中包括截至 8 月的幾個新進入者。核心營業收入下降 3%,主要是由於對 Entresto、Cosentyx 和 Alcon 的仿製藥侵蝕和增長投資,部分被生產力提高所抵消。
Operating income was up 1%, mainly due to a prior-year legal provisioning. Net income benefited from the higher operating income and income from associated companies, driven by our OTC joint venture, and was up 7% in the quarter. Core EPS was down 3% to $1.23, and free cash flow was $2.6 billion, which I will come back to later in my presentation.
營業收入增長 1%,主要是由於上一年的法律規定。在我們的場外交易合資企業的推動下,淨收入受益於更高的營業收入和關聯公司收入,本季度增長了 7%。核心每股收益下降 3% 至 1.23 美元,自由現金流為 26 億美元,我將在稍後的演講中再次提及。
Slide 20 shows the underlying volume growth and contribution to core operating income. Sales volume grew 5% in the quarter. We had negative impact of minus 2% on price and minus 4% from generics, which took us down to a minus 1% in constant currency.
幻燈片 20 顯示了潛在的銷量增長和對核心營業收入的貢獻。本季度銷量增長 5%。我們對價格產生了負 2% 的負面影響,對仿製藥產生了負 4% 的負面影響,這使我們以固定匯率計算下降到負 1%。
Currency impact was flat this quarter for the first time in two years, and so the US dollar sales also declined minus 1%. On core operating income, you'll see similar but more pronounced picture. Volume growth of plus 15% was more than offset by minus 7% on price and minus 11% of generics, but [flat] currency, both constant currency and USD, declined by 3%.
本季度貨幣影響兩年來首次持平,因此美元銷售額也下降了-1%。在核心營業收入方面,您會看到類似但更明顯的情況。超過 15% 的銷量增長被價格的負 7% 和仿製藥的負 11% 所抵消,但 [固定] 貨幣,包括固定貨幣和美元,下降了 3%。
On slide 21, you can see the growth drivers from the Innovative Medicines division. Joe already talked about Cosentyx and Entresto, but I would also like to highlight Gilenya, which continued to show double-digit growth behind the increasingly accepted positive efficacy and manageable safety profile.
在幻燈片 21 上,您可以看到創新藥物部門的增長動力。 Joe 已經談到了 Cosentyx 和 Entresto,但我還想強調 Gilenya,在日益被接受的積極療效和可控的安全狀況背後,它繼續呈現兩位數的增長。
I would also point our Tasigna grew 8% globally. The US share remains stable despite generic versions of Glivec. Key growth drivers in oncology, including Tafinlar Mekinist growing 29%, Revolade Promacta growing 44%, as well as Jakavi growing 47%, contributed to strong underlying sales growth and broadly offset the Glivec generic impact.
我還要指出我們的 Tasigna 在全球範圍內增長了 8%。儘管有通用版本的 Glivec,美國的份額仍保持穩定。腫瘤學的主要增長動力,包括 Tafinlar Mekinist 增長 29%、Revolade Promacta 增長 44% 以及 Jakavi 增長 47%,促成了強勁的基礎銷售增長,並廣泛抵消了 Glivec 仿製藥的影響。
Now I'd like to turn to margins on slide number 22. Core margin for the Group was 27.9%, down 0.6 percent points versus you last year. Let me walk you through the factors that influenced margin in the quarter.
現在我想談談第 22 號幻燈片的利潤率。集團的核心利潤率為 27.9%,比去年下降 0.6 個百分點。讓我向您介紹影響本季度利潤率的因素。
I'll begin with Innovative Medicines, our largest division. Given Glivec genericization, Innovative Medicines delivered a solid top-line performance with sales down only 1%. This was due to continued strong performance of our growth products in the division, which as a basket grew 21% in quarter three.
我將從我們最大的部門 Innovative Medicines 開始。考慮到 Glivec 的仿製藥,Innovative Medicines 的營收表現穩健,銷售額僅下降 1%。這是由於該部門增長產品的持續強勁表現,該部門在第三季度整體增長了 21%。
Core operating income was also down 1%, as productivity initiatives and resource allocation fully funded the growth investments into Entresto and Cosentyx. This resulted in the flat core margin of 32.7% of sales.
核心營業收入也下降了 1%,因為生產力舉措和資源分配為 Entresto 和 Cosentyx 的增長投資提供了充分的資金。這導致核心利潤率持平,佔銷售額的 32.7%。
Sandoz sales were down 1%, reflecting significantly lower launch activity in the US compared to a strong prior-year quarter, including the authorized generics launch of the Exelon Patch last year in quarter three. This launch volatility is part of your overall generics business model.
Sandoz 銷售額下降 1%,反映出與強勁的去年同期相比,美國的上市活動顯著減少,包括去年第三季度 Exelon Patch 的授權仿製藥上市。這種上市波動是您整體仿製藥業務模型的一部分。
As Joe mentioned, biopharmaceuticals continued to show strong growth in the quarter, up 41% to $262 million. Core operating income was up slightly, resizing in the core margin improvement of 0.2 percent points to 21.1% of sales.
正如喬所提到的,生物製藥在本季度繼續呈現強勁增長,增長 41% 至 2.62 億美元。核心營業收入略有上升,核心利潤率提高 0.2 個百分點,佔銷售額的 21.1%。
Turning to Alcon, sales declined 3% in the quarter, mainly due to competitive pressures on IOLs and cataract equipment in the surgical franchise, and soft Vision Care performance in North America. In quarter three, sales performance has been impacted slightly by some inventory phasing between quarter two and quarter three.
談到愛爾康,該季度的銷售額下降了 3%,這主要是由於手術特許經營中 IOL 和白內障設備的競爭壓力,以及北美視力保健的疲軟表現。在第三季度,銷售業績受到第二季度和第三季度之間一些庫存調整的輕微影響。
If you normalize for that, both quarter two and quarter three sales would have shown a 2% decline. Quarter-three core operating income was impacted by declining sales and increased M&S behind the growth plan, resulting in 6.8 percent points decline in core operating margin to 14.3% of sales.
如果對此進行標準化,則第二季度和第三季度的銷售額都會下降 2%。第三季度核心營業收入受到銷售額下降和 M&S 增長落後於增長計劃的影響,導致核心營業利潤率下降 6.8 個百分點至銷售額的 14.3%。
On slide 23, you see our free cash flow was $6.5 billion for the first nine months in the year, an increase of $0.2 billion over the prior-year period. The increase was mainly driven by favorable working capital, lower CapEx, and a dividend from our OTC joint venture with GSK, partially offset by lower operating income to nine months.
在幻燈片 23 上,您可以看到今年前 9 個月我們的自由現金流為 65 億美元,比去年同期增加 2 億美元。增長的主要原因是有利的營運資金、較低的資本支出以及我們與葛蘭素史克的場外交易合資企業的股息,部分被營業收入減少至九個月所抵消。
On slide 24, you can see that our net debt stood at $18.8 billion at the end of the first nine months compared to $16.5 billion at the end of last year, but down about $2 billion versus Q1 2016. The two biggest factors were the annual dividend payment and our nine-months free cash flow, which offset each other. Other small elements, including share buybacks to mitigate employee participation programs and small bolt-on M&A transactions, are shown on the slide and contribute to the increase in net debt.
在幻燈片 24 上,您可以看到前九個月末我們的淨債務為 188 億美元,而去年年底為 165 億美元,但與 2016 年第一季度相比下降了約 20 億美元。兩個最大的因素是年度股息支付和我們九個月的自由現金流相互抵消。幻燈片中顯示了其他小因素,包括股票回購以減輕員工參與計劃和小型補強併購交易,並導致淨債務增加。
On slide 25, I'd like to give a bit more color on the currency evolution. As I mentioned, this was the first quarter in two years where we haven't had a negative currency impact on the top or bottom line. If mid-October exchange rates hold for the remainder of the year, we would expect a currency impact of zero or no currency impact on the top line in quarter four, while the bottom line would have an impact of minus 1% in quarter four. This would lead to a full-year impact for 2016 of minus 1% on top line and minus 3% on the bottom line.
在幻燈片 25 上,我想為貨幣演變提供更多色彩。正如我所提到的,這是兩年來我們沒有對頂線或底線產生負面貨幣影響的第一季度。如果 10 月中旬的匯率在今年餘下時間保持不變,我們預計貨幣對第四季度收入的影響為零或沒有貨幣影響,而第四季度的收入影響為負 1%。這將對 2016 年的全年收入和利潤產生負 1% 和負 3% 的影響。
If we carry these mid-October exchange rates forward into 2017, we would expect a full-year currency impact of minus 1% on the top and bottom line in 2017. In terms of 2017, we'll give you specific business guidance in January when we have worked through detailed budgets for all of the businesses, but I wanted to take a moment here to highlight some of the headwinds and tailwinds for you.
如果我們將這些 10 月中旬的匯率推算到 2017 年,我們預計 2017 年全年貨幣對最高和最低利潤的影響為負 1%。就 2017 年而言,我們將在 1 月份為您提供具體的業務指導當我們完成所有業務的詳細預算時,但我想在這里花點時間為您強調一些逆風和順風。
In terms of tailwinds, clearly, we have Cosentyx, Entresto, and the new oncology assets, which we expect to deliver strong growth. We also have potential new launches, such as LEE, which Vas will talk about in his presentation. In addition, we expect growth from biopharmaceuticals.
就順風而言,顯然,我們擁有 Cosentyx 、 Entresto 和新的腫瘤學資產,我們預計它們將實現強勁增長。我們也有可能推出新產品,例如 Vas 將在他的演講中談到的 LEE。此外,我們預計生物製藥會出現增長。
Underpinning all of these top-line drivers, we have our ongoing productivity programs, including the centralization initiatives announced in January, which we expect to support Group margins. In terms of headwinds, we will continue to have significant generic exposure next year, primarily because of Glivec, as we lose exclusivity in Europe in December of 2016 and we'll have a full-year impact of generics in the US, with additional generic entrants expected.
支撐所有這些頂級驅動因素的是我們正在進行的生產力計劃,包括 1 月份宣布的集中化計劃,我們預計這些計劃將支持集團利潤率。就逆風而言,明年我們將繼續擁有大量的仿製藥曝光,主要是因為 Glivec,因為我們在 2016 年 12 月失去了在歐洲的獨家經營權,我們將在美國產生全年的仿製藥影響,額外的仿製藥預計進入者。
The fact that we have been able to sustain decent Glivec shares in the US this year will be a headwind for the growth dynamics next year, so please take this into account as you model 2017. In addition, for the bottom line, bear in mind, we will have the full-year impact for the Entresto of the expanded use for the US and some incremental investments, although smaller, for the new launches -- launch countries of Entresto, Cosentyx, and pre-launch and launch investments for LEE.
今年我們能夠在美國維持良好的 Glivec 股票這一事實將成為明年增長動力的逆風,因此請在 2017 年建模時考慮到這一點。此外,對於底線,請記住,我們將對 Entresto 的全年影響產生擴大在美國的使用和一些增量投資,儘管規模較小,但用於新的發射—— Entresto 、 Cosentyx 的發射國家,以及 LEE 的發射前和發射投資。
Now coming back to our 2016 guidance on slide 26, I can confirm our full-year outlook for the group. Group net sales are expected to be broadly in line with prior-year in constant currencies. Group core operating income is expected to be broadly in line or decline low single-digits in constant currencies.
現在回到我們在幻燈片 26 上的 2016 年指導,我可以確認我們對該集團的全年展望。按固定匯率計算,集團淨銷售額預計與上年大致持平。按固定匯率計算,集團核心營業收入預計將大致保持不變或下降低個位數。
From a divisional standpoint, at this point, we see Innovative Medicines reaching the high end of the sales guidance we gave in January. Innovative Medicines is year-to-date flat versus prior-year, and is expected to be broadly in line with the prior-year for the full year.
從部門的角度來看,在這一點上,我們看到創新藥物達到了我們在 1 月份給出的銷售指導的高端。創新藥物今年迄今與上年持平,預計全年與上年基本持平。
As you may recall from the January webcast, we guided for Innovative Medicines to be broadly in line to a slight decline versus prior-year. Alcon is minus 2% year-to-date. It's unlikely we will make the guidance of low single-digit growth for the year, but Alcon is expected to improve sales momentum in quarter four.
您可能還記得 1 月份的網絡廣播,我們指導創新藥物與去年同期相比略有下降。愛爾康今年迄今股價下跌 2%。我們不太可能製定今年低個位數增長的指引,但愛爾康有望在第四季度改善銷售勢頭。
Sandoz sales are expected to grow in quarter four, as they cycle over low prior-year base, so Sandoz full-year sales are expected to grow low to mid-single-digits, in line with guidance. Net, Innovative Medicines achieving the upper end of guidance offsets for Alcon, and hence at Group level, we are fully on track to achieve the full-year guidance.
Sandoz 銷售額預計將在第四季度增長,因為它們在上一年的低基數上循環,因此 Sandoz 全年銷售額預計將增長低至中等個位數,與指導一致。 Net,Innovative Medicines 實現了 Alcon 指導的上限,因此在集團層面,我們完全有望實現全年指導。
With that, I hand over to Vas.
有了這個,我交給 Vas。
- Global Head of Drug Development
- Global Head of Drug Development
Thank you, Harry. In Q3, we had another strong quarter, progressing our pipeline of Innovative Medicines, which now includes 12 potential blockbusters reading out over the next three years. Moving to the first slide, before reviewing our major data releases in the quarter, I wanted to provide an update on our development organization.
謝謝你,哈利。在第三季度,我們又迎來了一個強勁的季度,推進了我們的創新藥物管線,現在包括未來三年內的 12 種潛在重磅炸彈。轉到第一張幻燈片,在回顧我們本季度發布的主要數據之前,我想提供有關我們開發組織的最新信息。
We have now fully implemented a single global drug development organization across seven therapeutic areas, and fully integrated our global operations to increase our efficiency and productivity over the coming years. With over 100 projects in late-stage development and world-class operations, we are confident we can drive a steady stream of significant medical innovation.
我們現在已經在七個治療領域全面實施了一個單一的全球藥物開發組織,並全面整合了我們的全球業務,以在未來幾年提高我們的效率和生產力。憑藉 100 多個後期開發項目和世界一流的運營,我們有信心能夠推動源源不斷的重大醫療創新。
Moving to the next slide, we had another strong quarter in oncology, highlighted by our LEE data released at ESMO in October. In the MONALEESA-2 study, LEE showed significantly improved PFS, with a hazard ratio of 0.556 versus standard of care in first-line hormone receptor-positive, HER2-negative breast cancer, with an objective tumor response in over 50% of women with measurable disease.
轉到下一張幻燈片,我們在腫瘤學領域又迎來了一個強勁的季度,我們 10 月份在 ESMO 上發布的 LEE 數據突顯了這一點。在 MONALEESA-2 研究中,LEE 顯示 PFS 顯著改善,一線激素受體陽性、HER2 陰性乳腺癌的風險比為 0.556,超過 50% 的女性出現客觀腫瘤反應可測量的疾病。
It is the first CDK4/6 to meet its primary endpoint in a first-line setting at a pre-planned interim analysis. The FDA has granted breakthrough therapy designation for this drug and we are in the process of making regulatory submissions worldwide.
在預先計劃的中期分析中,它是第一個在一線設置中達到其主要終點的 CDK4/6。 FDA 已授予該藥物突破性療法認定,我們正在全球範圍內提交監管申請。
On the next slide, when looking at the safety profile of LEE, we believe we've demonstrated a positive benefit risk profile with manageable and generally infrequent adverse events, consistent with other broadly used agents. Discontinuations on the trial were very low, with only 25 patients discontinuing due to adverse events. These adverse events overall were manageable with dose reductions and with dose interruptions.
在下一張幻燈片中,當查看 LEE 的安全性概況時,我們相信我們已經展示了積極的效益風險概況,不良事件可控且通常很少發生,與其他廣泛使用的藥物一致。試驗中止的情況非常少,只有 25 名患者因不良事件而中止。通過減少劑量和中斷劑量,這些不良事件總體上是可控的。
Specifically, when we look at liver signals, we had four Hy's Law cases, but each of these cases resolved when we discontinued therapy. There were no fatal outcomes with any of these patients. In addition, consistent with our previous results, we did see cases of QT prolongation, with 11 cases greater than the standard of 480 milliseconds, but no deaths in the per-protocol population.
具體來說,當我們查看肝臟信號時,我們有四個 Hy 定律案例,但這些案例中的每一個都在我們停止治療時得到解決。這些患者均未出現致命結局。此外,與我們之前的結果一致,我們確實看到了 QT 延長的病例,其中 11 例大於 480 毫秒的標準,但符合方案人群沒有死亡。
With EKG monitoring during planned visits, we believe we can ensure patients can safely initiate LEE. Taken together, when we look at this data, we feel very confident in the profile. In particular, we'll be looking at additional sub-group analyses and our onset of action to differentiate LEE from other agents in this class.
通過計劃就診期間的 EKG 監測,我們相信我們可以確保患者可以安全地啟動 LEE。綜上所述,當我們查看這些數據時,我們對配置文件非常有信心。特別是,我們將研究額外的亞組分析和我們開始採取的行動,以將 LEE 與此類中的其他代理區分開來。
Moving to the next slide and looking at how we will take LEE forward in future trials, our MONALEESA-3 and MONALEESA-7 trials are now fully enrolled. MONALEESA-3 is our study in first- and second-line, in combination with fulvestrant, and we plan to be the first company with data with fulvestrant in the first-line setting, an important data set given recent data supporting fulvestrant's broad use.
轉到下一張幻燈片,看看我們將如何在未來的試驗中推動 LEE,我們的 MONALEESA-3 和 MONALEESA-7 試驗現已全部註冊。 MONALEESA-3 是我們在一線和二線的研究,結合氟維司群,我們計劃成為第一家在一線環境中使用氟維司群的數據的公司,鑑於最近的數據支持氟維司群的廣泛使用,這是一個重要的數據集。
In MONALEESA-7, we will have the first data set in pre-menopausal women. In addition to these two trials, we're also assessing studies of LEE in the adjuvant setting, as well as exploring additional solid tumor indications, and we'll provide further updates on those programs in the coming quarters.
在 MONALEESA-7 中,我們將擁有絕經前女性的第一個數據集。除了這兩項試驗外,我們還在評估 LEE 在輔助環境中的研究,以及探索其他實體瘤適應症,我們將在未來幾個季度提供這些項目的進一步更新。
On the next slide, I wanted to give you an update, as well, on our CAR-T programs. As Joe mentioned, we are continuing to rapidly progress our late-stage programs in ALL and DLBCL. We've integrated the cell and gene therapy unit into our oncology development operations.
在下一張幻燈片上,我也想向您介紹我們的 CAR-T 計劃的最新情況。正如 Joe 所提到的,我們正在繼續快速推進 ALL 和 DLBCL 的後期項目。我們已將細胞和基因治療部門整合到我們的腫瘤開發業務中。
We are on track for a Q1 submission of our pediatric ALL program, a program that's received break-through therapy designation from the FDA. In addition, our DLBCL program is on track, with a program in third-line relapsed/refractory disease that we aim to file in the second half of 2017. Beyond these programs, we continue to work closely with the University of Pennsylvania to advance additional CAR-T therapies in hematologic and solid tumors.
我們有望在第一季度提交我們的兒科 ALL 計劃,該計劃已獲得 FDA 的突破性治療指定。此外,我們的 DLBCL 計劃正在進行中,我們計劃在 2017 年下半年提交一項三線復發/難治性疾病計劃。除了這些計劃,我們繼續與賓夕法尼亞大學密切合作,以推進更多CAR-T 療法在血液腫瘤和實體腫瘤中的應用。
Moving to slide 33 and to our neuroscience portfolio, we recently released data from BAF312, where we demonstrated a reduction in the risk of disability progression in patients with secondary progressive MS, in the EXPAND trial. In this study, we demonstrated a 21% risk reduction on three-month confirmed disability progression, the primary endpoint. But even more importantly, we also the showed data was consistent at the six-month time point, with a 26% risk reduction, and also with an important efficacy trend across key secondary endpoints.
轉到幻燈片 33 和我們的神經科學組合,我們最近發布了 BAF312 的數據,我們在 EXPAND 試驗中證明了繼發性進展性 MS 患者殘疾進展風險的降低。在這項研究中,我們證明三個月確認的殘疾進展風險降低了 21%,這是主要終點。但更重要的是,我們還顯示數據在六個月的時間點是一致的,風險降低了 26%,並且關鍵次要終點的療效趨勢也很重要。
This patient population in this trial was representative of secondary progressive MS disease, with 64% of the patients presenting with non-relapsing disease at baseline. Overall, the safety profile of BAF312 was comparable to other drugs in this class, and we view the overall risk benefit as highly positive.
該試驗中的這一患者群體代表繼發性進展性 MS 疾病,其中 64% 的患者在基線時表現出非複發性疾病。總的來說,BAF312 的安全性與同類中的其他藥物相當,我們認為整體風險收益非常積極。
When you go to the next slide and you look at BAF's profile in specific subgroups, you can see that the drug demonstrated efficacy in patients who did not have gadolinium enhancing lesions at baseline, as well as patients who had progressive disease at baseline. This is important, because in both cases, that demonstrates we are targeting the patient population that is at the highest unmet need and that's some of the data we believe regulators will be closely looking at in our discussions ahead. We will be moving forward with those discussions by early next year to determine whether a single study submission will be allowable for this program and we will keep you updated accordingly.
當您轉到下一張幻燈片並查看 BAF 在特定亞組中的概況時,您可以看到該藥物對基線時沒有钆增強病變的患者以及基線時疾病進展的患者均有效。這很重要,因為在這兩種情況下,這表明我們的目標是未滿足需求最高的患者群體,這是我們認為監管機構將在我們未來的討論中密切關注的一些數據。我們將在明年初推進這些討論,以確定該計劃是否允許提交一份研究報告,我們會及時通知您最新情況。
Moving to slide 35, we also released important data for AMG 334, our migraine drug in collaboration with Amgen. Importantly, migraine prophylaxis remains a significant area of unmet need globally. It's the sixth highest cause of worldwide years lost to disability.
轉到幻燈片 35,我們還發布了與 Amgen 合作的偏頭痛藥物 AMG 334 的重要數據。重要的是,偏頭痛預防仍然是全球未滿足需求的重要領域。它是世界範圍內因殘疾損失的第六大原因。
As you can see from this graph, the figures here show that many millions of patients suffer from this disease with inadequate treatment available. In general, the medications used in prophylactic migraine therapy have incomplete efficacy and many have adverse event profiles that limit their use.
從這張圖中可以看出,這裡的數字表明,數百萬患者患有這種疾病,但治療不當。一般而言,用於預防性偏頭痛治療的藥物療效不完全,許多藥物具有限制其使用的不良事件特徵。
Moving to slide 36, our data in AMG 334 released this fall demonstrated that in episodic migraine, that we had a significant reduction in monthly migraine days versus placebo. The primary endpoint was met and the secondary endpoints were all in line with our expectations.
轉到幻燈片 36,我們在今年秋天發布的 AMG 334 中的數據表明,在發作性偏頭痛中,與安慰劑相比,我們每月的偏頭痛天數顯著減少。達到主要終點,次要終點均符合我們的預期。
The safety profile for AMG was generally excellent. We also have a second episodic migraine trial in collaboration with Amgen that we'll be reading out later in Q4, and we will be then able to move forward with our plans to file this drug within Europe and the rest of the world.
AMG 的安全性總體上非常好。我們還與 Amgen 合作進行了第二次發作性偏頭痛試驗,我們將在第四季度晚些時候宣讀,然後我們將能夠推進我們在歐洲和世界其他地區提交這種藥物的計劃。
Moving to the next slide, in addition to our data in episodic migraine, we also released the full data set in chronic migraine from a Phase II B study. Similarly, we demonstrated a significant improvement in monthly migraine days in this chronic migraine population. These are patients who suffer from the disease for more than 14 days a month.
轉到下一張幻燈片,除了我們的發作性偏頭痛數據外,我們還發布了來自 II B 期研究的慢性偏頭痛的完整數據集。同樣,我們證明了這個慢性偏頭痛人群的每月偏頭痛天數有了顯著改善。這些患者每月患這種疾病的時間超過 14 天。
Secondary endpoints were also positive, with significantly more patients on AMG 334 having monthly migraine day reductions across sub-groups. Overall, also the safety profile was positive. So taking these two studies together, we're progressing on track to be amongst the first competitors on the market with a novel medicine for migraine.
次要終點也是積極的,在 AMG 334 中有更多的患者在各亞組中每月偏頭痛天數減少。總體而言,安全狀況也是積極的。因此,將這兩項研究結合起來,我們正朝著成為市場上第一批偏頭痛新藥競爭者的方向發展。
Moving to slide 38, Cosentyx continued to deliver important long-term data that demonstrates the importance of having an antibody that's fully human with limited injection site reactions and limited anti-drug antibodies that enable this drug to have consistent efficacy for many years. Data released in the SCULPTURE Phase III trial demonstrated that we have four-year maintenance of the efficacy of Cosentyx with excellent safety throughout this period.
轉到幻燈片 38,Cosentyx 繼續提供重要的長期數據,這些數據證明了具有完全人源抗體的重要性,該抗體具有有限的注射部位反應和有限的抗藥物抗體,使該藥物能夠在多年內保持一致的療效。 SCULPTURE III 期試驗中發布的數據表明,我們在整個期間保持了四年的 Cosentyx 療效和出色的安全性。
It's worth noting almost 100% of patients whose achieved a PASI 100 score maintained that score at four years. Patients remain on the drug at a very high rate, demonstrating its strong safety profile. In addition, we are in the process now of starting head-to-head studies versus Humira in both ankylosing spondylitis and psoriatic arthritis to establish Cosentyx as the drug in this disease.
值得注意的是,幾乎 100% 的達到 PASI 100 分數的患者在四年內都保持了該分數。患者繼續服用該藥物的比例很高,證明了其強大的安全性。此外,我們現在正在開始與修美樂在強直性脊柱炎和銀屑病關節炎方面的頭對頭研究,以確定 Cosentyx 作為治療這種疾病的藥物。
Moving to Entresto on slide 39, our FortiHFy program, an expansive program of clinical trials to profile Entresto across different patient populations and indications, continues to progress on track. Our PARAGON heart failure study for preserved ejection heart failure is on track for read-out in 2019. Our PARADISE program in the post-myocardial infarction population is on track for start later this year and also with a planned read-out in 2019.
轉到幻燈片 39 上的 Entresto,我們的 FortiHFy 計劃是一個擴展的臨床試驗計劃,旨在分析 Entresto 在不同患者人群和適應症中的情況,繼續按計劃推進。我們針對保留射血性心力衰竭的 PARAGON 心力衰竭研究有望在 2019 年進行宣讀。我們針對心肌梗死後人群的 PARADISE 計劃有望在今年晚些時候啟動,併計劃在 2019 年進行宣讀。
In addition, our study programs, including the two studies listed here, TRANSITION and PIONEER, which look at initiating Entresto in the hospital setting, or on discharge, are also on track and recruiting on plan. Overall, building off our strong guidelines and recommendations we received earlier this year, we continue to generate evidence to support broad Entresto use.
此外,我們的研究項目,包括此處列出的兩項研究,TRANSITION 和 PIONEER,著眼於在醫院環境中或出院時啟動 Entresto,也正在按計劃進行招募。總的來說,基於我們今年早些時候收到的強有力的指導方針和建議,我們繼續收集證據來支持 Entresto 的廣泛使用。
Moving to slide 40, we are also rapidly progressing our cardiovascular portfolio with our Phase III Serelaxin and CANTOS programs. As a reminder, the RELAX-AHF-1 trial demonstrated a 37% reduction in cardiovascular death at day 180, with a highly statistically significant result.
轉到幻燈片 40,我們還通過我們的 III 期 Serelaxin 和 CANTOS 計劃快速推進我們的心血管產品組合。提醒一下,RELAX-AHF-1 試驗表明,在第 180 天,心血管死亡率降低了 37%,具有高度統計學意義的結果。
With the RELAX-AHF-2 study, we powered the study to really fully evaluate the efficacy benefit, with 6,600 patients and with a primary endpoint both of cardiovascular deaths and worsening heart failure. We are on track for a study read-out in the first half of 2017. In addition, the CANTOS program is fully on track for completion in 2017, having completed a final DMC review.
通過 RELAX-AHF-2 研究,我們為這項研究提供了動力,以真正全面地評估療效益處,涉及 6,600 名患者,主要終點是心血管死亡和心力衰竭惡化。我們正按計劃在 2017 年上半年進行研究宣讀。此外,CANTOS 計劃完全按計劃於 2017 年完成,完成了最終的 DMC 審查。
Moving to slide 41, when you look across our entire portfolio, we are continuing to progress 12 potential blockbusters in Innovative Medicines. All of these programs are on track and we feel confident that we have one of the leading portfolios in the industry of significant medicines for patients and the healthcare system.
轉到幻燈片 41,當您查看我們的整個產品組合時,我們將繼續推進創新藥物領域的 12 種潛在重磅炸彈。所有這些項目都在按計劃進行,我們有信心我們在為患者和醫療保健系統提供重要藥物的行業中擁有領先的產品組合之一。
Turning to our biosimilars portfolio on slide 42, we've had a couple important events that I wanted to provide you an update on. As Joe mentioned, Etanercept, our biosimilar, has received an FDA approval across all indications and we continue to progress our filing in the EU.
轉到幻燈片 42 上的我們的生物仿製藥產品組合,我們有幾個重要事件,我想為您提供更新。正如 Joe 提到的,我們的生物仿製藥 Etanercept 已獲得 FDA 對所有適應症的批准,我們將繼續推進我們在歐盟的申請。
For Pegfilgrastim, as we noted in Q2, we did receive a complete response letter and are continuing to engage in discussions with both the FDA and with EMA. In the US, we have agreed with FDA to move forward with an additional study to address their data request and we would expect to submit that study to the FDA in 2018.
對於 Pegfilgrastim,正如我們在第二季度所指出的,我們確實收到了一封完整的回复函,並且正在繼續與 FDA 和 EMA 進行討論。在美國,我們已與 FDA 同意推進一項額外的研究來解決他們的數據請求,我們預計將在 2018 年將該研究提交給 FDA。
And finally with Infliximab, a program we partnered from Pfizer, we have Phase III data from our partner that demonstrated equivalent efficacy and safety to Remicade. Overall, when you go to the next slide, we are on track to progress our biosimilars portfolio and we're very pleased with the progress that we've had to date.
最後,英夫利昔單抗是我們與輝瑞公司合作的一個項目,我們從我們的合作夥伴那裡獲得了 III 期數據,這些數據證明了與 Remicade 等效的療效和安全性。總的來說,當你轉到下一張幻燈片時,我們正在推進我們的生物仿製藥產品組合,我們對迄今為止取得的進展感到非常滿意。
With that, I thank you very much, and I hand it back to Joe.
有了這個,我非常感謝你,我把它還給喬。
- CEO
- CEO
To conclude, we had a solid quarter. Our launches are progressing well. We still have work to do on Alcon, but we had strong innovation across all of our divisions and that sets us up well for the future.
總而言之,我們有一個穩定的季度。我們的發布進展順利。我們在 Alcon 方面仍有工作要做,但我們所有部門都有強大的創新能力,這為我們的未來做好了準備。
Before we go to Q&A, I just want to make a final point. On January 25, we're going to present our full-year results and we're also going to provide guidance for 2017, but we're going to take the opportunity on that day to provide a more in-depth look at our pipeline.
在我們進行問答之前,我只想說最後一點。 1 月 25 日,我們將公佈我們的全年業績,我們還將提供 2017 年的指導,但我們將在那天藉此機會更深入地了解我們的管道.
So we're going to host a live event for analysts and investors in Basel on that day with Vas, Jay, and some of their team members, together with the ECNs. For those of you who can't make it in person, we're also going to have a live video webcast, so we hope to see you there.
因此,我們將在那天與 Vas、Jay 和他們的一些團隊成員以及 ECN 一起在巴塞爾為分析師和投資者舉辦一場現場活動。對於那些不能親自到場的人,我們還將進行現場視頻網絡廣播,所以我們希望能在那裡見到你。
Now I'd like to open the call to questions.
現在我想開始提問。
Operator
Operator
(Operator Instructions)
(操作員說明)
The first question comes from the line of Jeff Holford from Jefferies. Please go ahead.
第一個問題來自 Jefferies 的 Jeff Holford。請繼續。
- Analyst
- Analyst
Thanks very much for taking my questions, everyone. Just three questions. First on Alcon. You're saying this is going to take a bit longer to return to growth, but how long is that? Can you try and give us some expectation around that in 2017?
非常感謝大家回答我的問題。就三個問題。首先是愛爾康。你是說這需要更長的時間才能恢復增長,但那需要多長時間?你能試著給我們一些關於 2017 年的期望嗎?
Secondly, we've been reading in the Swiss press some updates around the Roche stake, that, that's potentially going to take longer to execute the sale of that stock. Also, we would infer ourselves that the potential separation of Alcon could take a bit longer, as well.
其次,我們一直在瑞士媒體上閱讀有關羅氏股份的一些最新消息,即執行該股票的出售可能需要更長的時間。此外,我們會自己推斷,Alcon 的潛在分離也可能需要更長的時間。
Then we've also been hearing various pieces of commentary around your M&A focus. Is it on larger companies or smaller companies? Could you just give us an update on those potential disposals and your M&A focus? And then just last question, quick one on Entresto, just give us some update around prior authorizations, any progress that might be making there in the United States? Thank you.
然後我們也聽到了關於您的併購重點的各種評論。它適用於大公司還是小公司?您能否向我們介紹一下這些潛在處置和您的併購重點的最新情況?然後是最後一個問題,關於 Entresto 的快速問題,請給我們一些關於事先授權的更新,在美國可能取得的任何進展?謝謝。
- CEO
- CEO
Okay, let's start with Mike on Alcon?
好的,讓我們從 Mike on Alcon 開始吧?
- CEO of Alcon
- CEO of Alcon
Thanks, Joe. I want to just give you some color in addition to what Joe mentioned. We've had a really busy eight months, but the objectives remain the same, is to drive that top line back to growth, to get to long-term sustainable growth. I think we have the right plan, I believe we're taking the right actions, and they will ultimately read through to the right result.
謝謝,喬。除了 Joe 提到的內容之外,我只想給你一些顏色。我們度過了非常忙碌的八個月,但目標保持不變,即推動收入恢復增長,實現長期可持續增長。我認為我們有正確的計劃,我相信我們正在採取正確的行動,他們最終會讀到正確的結果。
Let me remind you what we were talking about on previous calls in terms of our major activities. That was four key things: we're going to invest to grow; we're going to drive innovation; we're going to improve Alcon's basic operations; and we're going to strengthen customer relationships.
讓我提醒您,我們在之前的電話會議上就我們的主要活動談過什麼。那是四件關鍵的事情:我們要投資以發展;我們將推動創新;我們將改善愛爾康的基本運營;我們將加強客戶關係。
As you step back and look at Alcon, really it's comprised of two major businesses: a vision care business, which is a consumer business, and then the surgical business, which is obviously a medical device business. If you look at the consumer business, consumer businesses tend to turn around faster as a result of investment in promotion.
當你退後一步看愛爾康時,它實際上由兩大業務組成:視力保健業務,這是一項消費業務,然後是手術業務,這顯然是醫療設備業務。如果你看看消費者業務,由於對促銷的投資,消費者業務往往會更快地扭轉局面。
So we took then the decision right back in Q1 to put DTC, direct-to-consumer advertising, against vision care, and we started in Europe because we were set to go there. When I step back and look at the results in Europe, I'm very pleased. In the countries where we did implement direct-to-consumer advertising, we did see market share increases, and as a consequence, sales growth.
所以我們在第一季度就做出了決定,將直接面向消費者的廣告 DTC 與視力保健放在一起,我們從歐洲開始,因為我們準備去那裡。當我回頭看看歐洲的結果時,我感到非常高興。在我們實施直接面向消費者廣告的國家/地區,我們確實看到了市場份額的增加,並因此實現了銷售額增長。
As Joe mentioned in his opening dialogue, if you step back and look at overall lenses, contact lenses actually grew over the last six months. If you look at overall vision care, vision care actually was flat to last six months versus being down 6% for the prior six months. So when I look through you that, I say we're moving in the right direction there, so the first things, direct-to-consumer, appear to be working.
正如喬在開場白中提到的那樣,如果你退後一步看一下整體鏡片,隱形眼鏡在過去六個月中實際上有所增長。如果你看一下整體視力保健,視力保健實際上持續了六個月,而前六個月下降了 6%。所以當我通過你看的時候,我說我們正在朝著正確的方向前進,所以第一件事,直接面向消費者,似乎是有效的。
North America is where we've had the real issues in vision care. We are putting DTC around vision care in North America. That started the back end of Q3 and will go through Q4. We also, as Joe mentioned, launched the DT1 Multifocal in the US and in Europe, and I see real opportunity for this lens.
北美是我們在視力保健方面遇到真正問題的地方。我們正在將 DTC 用於北美的視力保健。那開始了第三季度的後端,並將持續到第四季度。正如喬提到的,我們還在美國和歐洲推出了 DT1 Multifocal,我看到了這款鏡頭的真正機會。
So as we go forward, the presbyopic market is huge and I see great opportunities for this lens to penetrate that particular market. I should also say that we also got very favorable feedback from our retailers as a consequence of seeing our direct-to-consumer activities, so I'm hoping that again this whole consumer activity continues to give us positive results, and we'll look forward to quarter four then in terms of how that reads out in the quarter.
因此,隨著我們的前進,老花眼市場是巨大的,我看到了這種鏡片滲透到該特定市場的巨大機會。我還應該說,由於看到我們直接面向消費者的活動,我們也從零售商那裡得到了非常有利的反饋,所以我希望整個消費者活動能夠再次給我們帶來積極的結果,我們會看看前進到第四季度,然後就本季度的情況而言。
Turning to surgical then, surgical, it takes longer for actions to translate into sales but they ultimately do and we've got a lot of activity going on. If I look at innovation, which was one of the first things we pursued, in quarter one, we went out and got the CyPass, which Joe described, and the NGENUITY.
然後轉向手術,手術,將行動轉化為銷售需要更長的時間,但他們最終會這樣做,而且我們正在進行很多活動。如果我看一下創新,那是我們在第一季度追求的首要目標之一,我們出去獲得了 Joe 描述的 CyPass 和 NGENUITY。
We just got approved for CyPass in the third quarter and we're just rolling it out right now, slowly, with training in the United States, but this is a very exciting marketplace, gets us into the glaucoma market in surgical, which is small, $100 million, but growing rapidly. NGENUITY is one of the big hit at the American Academy of Ophthalmology, which was just held in Chicago, and this is a really innovative 3D visualization system for [vitenal]-retinal surgeons.
我們剛剛在第三季度獲得了 CyPass 的批准,我們現在正在慢慢推出它,在美國進行培訓,但這是一個非常令人興奮的市場,讓我們進入外科手術的青光眼市場,這是一個很小的市場, 1 億美元,但增長迅速。 NGENUITY 是剛剛在芝加哥召開的美國眼科學會上的重頭戲之一,對於 [vitenal]-視網膜外科醫生來說,這是一個真正創新的 3D 可視化系統。
Turning to IOLs for a moment, we have for the past couple of years been under heavy competitive pressure, and we have been losing unit share. However, I'm very encouraged by the uptake of our trifocal lens, PanOptix, in Europe. We're launching it now in Latin America and we will have further launches of that product outside the United States.
暫時轉向 IOL,過去幾年我們一直承受著巨大的競爭壓力,我們一直在失去單位份額。然而,我對我們的三焦點鏡片 PanOptix 在歐洲的採用感到非常鼓舞。我們現在正在拉丁美洲推出它,我們將在美國以外進一步推出該產品。
In addition, UltraSert, which is our pre-loaded IOL injection system, and a very innovative one, is just getting launched as well in the United States and Europe, and the initial reports show very good pick-up from that. We will be launching it in Japan later on in the year.
此外,UltraSert 是我們的預加載 IOL 注射系統,也是一種非常創新的系統,它也剛剛在美國和歐洲推出,初步報告顯示它的效果非常好。我們將在今年晚些時候在日本推出它。
Speaking of Japan, we also launched a new [coated] lens called the [A-code] lens and this is a specific lens designed for the Japanese market, which is more cosmetically elegant, if you will, from an IOL standpoint. Lastly on that, on service levels. Joe alluded to them, but let me tell you the importance of getting back to service levels that are consistent with good customer service.
說到日本,我們還推出了一種名為 [A 代碼] 鏡片的新型 [鍍膜] 鏡片,這是專為日本市場設計的鏡片,從 IOL 的角度來看,如果您願意的話,它在外觀上更加優雅。最後,關於服務水平。 Joe 提到了他們,但讓我告訴您恢復與良好客戶服務一致的服務水平的重要性。
The last couple of years we've struggled with supply there. Candidly, we struggled with supply in the third quarter as well; however, exiting the third quarter, we are seeing service levels the best we have seen in the last one to two years, so that is a necessity for any recovery to occur.
在過去的幾年裡,我們一直在努力解決那裡的供應問題。坦率地說,我們在第三季度也遇到了供應問題;然而,在第三季度結束後,我們看到了過去一兩年來最好的服務水平,因此這是實現任何復甦的必要條件。
We've done a lot of other things in making ourselves easier to do business with, as Joe mentioned, putting systems in place. We've added then more talent into the Organization, where opthalmology runs in their blood. So overall, I feel very good about where this Organization is progressing, and underneath, things are going fine.
正如喬提到的那樣,我們已經做了很多其他的事情來讓我們自己更容易做生意,把系統放到位。我們為組織增加了更多的人才,眼科在他們的血液中流淌。因此,總的來說,我對本組織的進展感到非常滿意,而且在本質上,事情進展順利。
- CEO
- CEO
And Jeff, just in terms of 2017, Mike's building the budget right now. We're going through some investment trade-offs, and so we'll be able to provide guidance for 2017 on that January date. Regarding your two other questions on Roche and M&A, our strategy in M&A is to find bolt-ons that would enhance the pipelines of all three divisions, or improve the competitive position in a certain market, and anywhere in the range of $2 billion to $5 billion.
傑夫,就 2017 年而言,邁克現在正在製定預算。我們正在經歷一些投資權衡,因此我們將能夠在 1 月的那一天提供 2017 年的指導。關於你關於羅氏和併購的另外兩個問題,我們在併購方面的策略是尋找可以增強所有三個部門的產品線或提高在某個市場的競爭地位的補強方案,範圍在 20 億美元到 5 美元之間十億。
We've been pretty consistent in terms of how we have talked about going after those. It would be ideal to redeploy cash held in assets such as the Roche stake into those kinds of assets. We're being very financially disciplined so we're looking at everything, we're evaluating everything that comes on the market, or even try to free up into the market, and so there's really nothing new to report at this time. Next question, please?
就我們如何談論追求這些而言,我們一直非常一致。將羅氏股份等資產中持有的現金重新部署到這些資產中是理想的選擇。我們在財務上非常自律,所以我們正在研究一切,我們正在評估市場上出現的一切,甚至試圖釋放進入市場,所以目前真的沒有什麼新鮮事要報告。請問下一個問題?
- CEO of Novartis Pharmaceuticals
- CEO of Novartis Pharmaceuticals
Do you want me to--?
你想讓我——?
- CEO
- CEO
Sorry, Entresto, prior-auths?
對不起,Entresto,事先授權?
- CEO of Novartis Pharmaceuticals
- CEO of Novartis Pharmaceuticals
Okay, Jeff, thanks for the question on prior-auths. We're right in that window now, where these things are getting announced for the major PBMs in the US, as you know. Just some headlines, we've made incredible progress on this area. There are two aspects to it.
好的,傑夫,感謝您提出有關先驗授權的問題。我們現在就在那個窗口,如你所知,美國主要 PBM 正在宣布這些事情。只是一些頭條新聞,我們在這個領域取得了令人難以置信的進展。它有兩個方面。
One is that we've got PAs now, we hope to have PAs set up for the beginning of the year where it will be reduced to almost nothing. But in the main, we just get an improved level of simplification of the PA, and that's what we are focusing on.
一是我們現在有了 PA,我們希望在今年年初建立 PA,屆時它會減少到幾乎沒有。但總的來說,我們只是提高了 PA 的簡化程度,這就是我們關注的重點。
So we should see good progress in the New Year. I get asked a little bit about the change in guidelines and how that's helped. This is one of the key areas where the guidelines have really given confidence to a simplification of the PA, and we can talk about that again if you need to.
因此,我們應該在新的一年裡看到良好的進展。我被問到一些關於指導方針的變化以及它是如何幫助的。這是指南真正為簡化 PA 提供信心的關鍵領域之一,如果需要,我們可以再次討論。
- Analyst
- Analyst
That's great. Thanks very much.
那太棒了。非常感謝。
Operator
Operator
The next question comes from the line of Richard Vosser from JPMorgan. Please go ahead.
下一個問題來自摩根大通的 Richard Vosser。請繼續。
- Analyst
- Analyst
Hi, thanks for taking my questions. If I could just follow-up, just a couple on Alcon to start with. You alluded to improvements in IOLs, but could you just tell us whether you've stopped losing market share, first of all, very simply, and if not, what can be done to stop it in the short-term?
您好,感謝您回答我的問題。如果我可以跟進,首先是愛爾康的一對夫婦。您提到了 IOL 的改進,但您能否首先簡單地告訴我們您是否已經停止失去市場份額,如果沒有,短期內可以採取什麼措施來阻止它?
Secondly, we see an increasing cost typically in the fourth quarter in Alcon. Should we be thinking about this continuing in the same pattern this year, in 2016? Then moving to pharma, just a question you talked about LEE, but could you just give a little bit more thought to the idea of the commercial rollout of LEE, given the monitoring requirement that you alluded to, the NGM alluded to, around the heart and given the fact that IBRANCE doesn't have that monitoring requirement?
其次,我們看到愛爾康的成本通常在第四季度增加。我們是否應該考慮在 2016 年以同樣的模式繼續這種情況?然後轉向製藥,只是一個關於 LEE 的問題,但考慮到您提到的監控要求,NGM 提到的圍繞心臟的監控要求,您能否再多考慮一下 LEE 的商業推廣的想法考慮到 IBRANCE 沒有監控要求這一事實?
Then finally just on Gilenya prescriptions, it seems like the prescription trends are starting to slow down, so a couple questions here. Is that what you're seeing in your shipment data into the US? And as we think about pricing into 2017, a lot of the growth is driven by price rises at the moment, so could you give some perspective in terms of pricing in that area going forward? Thanks very much.
最後,關於 Gilenya 處方,處方趨勢似乎開始放緩,所以這裡有幾個問題。這是您在運往美國的貨運數據中看到的嗎?當我們考慮到 2017 年的定價時,目前很多增長都是由價格上漲推動的,那麼您能否就該領域未來的定價給出一些看法?非常感謝。
- CEO
- CEO
Mike, on IOLs?
邁克,在人工晶狀體上?
- CEO of Alcon
- CEO of Alcon
On IOLs, again, if you look at it from a global standpoint, we are in fact losing market share. What we need to do is, first of all, return the sales to flat and then growing, and then we will come to market share after that. The list of things that I outlined are the right things to be doing in terms of turning the business, but it takes a period of time for it to read through, so as we're just getting underway with some of these initiatives, they in fact will not be immediate, as I said; they will come, I believe, but it will take is some time.
同樣,在人工晶狀體方面,如果你從全球的角度來看,我們實際上正在失去市場份額。我們需要做的是,首先,將銷售額恢復到持平,然後再增長,然後我們將獲得市場份額。我概述的事情清單是在轉變業務方面應該做的正確事情,但需要一段時間才能通讀,因此由於我們剛剛開始實施其中的一些舉措,他們在正如我所說,事實不會立竿見影;他們會來的,我相信,但這需要一些時間。
In terms of costs then on quarter four, as I mentioned we're doing heavy direct-to-consumer advertising activities in Q3 that will continue into Q4. Our strong sense is, the overall objective, as I mentioned earlier, is to return the top line to growth. To do so, we're putting a bolus of money then in, to try and get that top line turned around, so that's what's underlying that.
就第四季度的成本而言,正如我所提到的,我們在第三季度進行大量直接面向消費者的廣告活動,並將持續到第四季度。我們的強烈感覺是,正如我之前提到的,總體目標是使收入恢復增長。為此,我們投入了大量資金,試圖扭轉這一局面,這就是其背後的原因。
- CEO
- CEO
Bruno, on LEE commercial rollout?
Bruno,關於 LEE 商業推廣?
- CEO of Novartis Oncology
- CEO of Novartis Oncology
As Vas mentioned before, side effects only occurred in a small number of patients. In the case of the QTc, it was 3.3% of the patients, and they were very quickly identifiable, manageable, and reversible.
正如 Vas 之前提到的,副作用只發生在少數患者身上。在 QTc 的情況下,它佔患者的 3.3%,並且它們可以非常快速地識別、管理和可逆。
While each product and competitive situation is unique, I'd like to perhaps make a parallel with another product that we have in our portfolio, Tasigna, which also had QT prolongation, and which was launched second to the market. Its competitor didn't have a QT prolongation, and we ended up having Tasigna being a blockbuster, and the blockbuster that you know, with almost one-half of the second-generation TKI market share, so we believe that this will be very manageable.
雖然每種產品和競爭情況都是獨一無二的,但我可能想與我們產品組合中的另一種產品 Tasigna 進行比較,它也有 QT 延長,並且是第二個上市的。它的競爭對手沒有 QT 延長,我們最終讓 Tasigna 成為重磅炸彈,你知道的重磅炸彈幾乎佔第二代 TKI 市場份額的一半,所以我們相信這將是非常可控的.
- CEO
- CEO
Okay. Paul on Gilenya scripts?
好的。保羅在 Gilenya 腳本上?
- CEO of Novartis Pharmaceuticals
- CEO of Novartis Pharmaceuticals
Thank you. It's broadly flat, a little bit down, but we have some sensible plans. Not a big impact from what I remember on price, and looking forward to the energy into Q4.
謝謝。它大致持平,有點下降,但我們有一些明智的計劃。我記得對價格沒有太大影響,並期待第四季度的活力。
- CEO
- CEO
Thanks, Richard.
謝謝,理查德。
Operator
Operator
The next question comes from the line of Andrew Baum from Citi. Please go ahead.
下一個問題來自花旗銀行的 Andrew Baum。請繼續。
- Analyst
- Analyst
Thank you. Three questions please. First, on LEE011, the four cases of Hy's Law, each one might carry -- or a 10% risk of death associated with it historically. We would imagine that you would get mandatory hepatic monitoring, as well as cardiovascular monitoring. Is that consistent with your own internal expectations?
謝謝。請教三個問題。首先,在 LEE011 上,Hy's Law 的四個案例,每個案例都可能攜帶 - 或者歷史上與之相關的 10% 的死亡風險。我們可以想像你會得到強制性的肝臟監測和心血管監測。這是否符合您自己的內部期望?
Then following on from that, while I note your point on Tasigna versus Sprycel, here you seem to have very similar hazard ratios. They certainly have a time advantage, they are not burdened with either, so what am I missing here? Why aren't physicians going to use IBRANCE, at least until you have the FASLODEX combination data?
然後從那開始,雖然我注意到你對 Tasigna 與 Sprycel 的觀點,但在這裡你似乎有非常相似的風險比。他們當然有時間優勢,他們也沒有負擔,所以我在這裡錯過了什麼?為什麼醫生不打算使用 IBRANCE,至少在您擁有 FASLODEX 組合數據之前?
Second, on CDK4/6s, you'd had Tasigna removed from the CVS formulary for next year. Do you anticipate a similar dynamic here, given there will be three CDK-4/6s on the market? Should we expect this is a new reality where small molecule oncology drugs are subject to PBM criteria?
其次,在 CDK4/6s 上,您已將 Tasigna 從明年的 CVS 處方集中刪除。考慮到市場上將有三個 CDK-4/6,您預計這裡會出現類似的動態嗎?我們是否應該期待這是一個小分子腫瘤藥物受 PBM 標準約束的新現實?
Then finally, Pfizer's CEO has commented on the need for consolidation within the industry given the pressures on reimbursement. How are you thinking about the broader context of large-scale M&A within that and the opportunities it may offer for Novartis? Thank you.
最後,鑑於報銷壓力,輝瑞公司的首席執行官評論了行業內整合的必要性。您如何看待其中大規模併購的更廣泛背景以及它可能為諾華提供的機會?謝謝。
- CEO
- CEO
Okay. Start with Vas on LEE?
好的。從 Vas on LEE 開始?
- Global Head of Drug Development
- Global Head of Drug Development
Thanks for the question. On LEE, on the four Hy's Law cases, certainly we're going to have conversations with FDA and EMA to figure out what's the best way to protect patients' interests. I would note that within the class of CDK4/6, neutropenia is an on-target effect and there is regular monitoring of these patients in terms of their overall blood level of neutrophils.
謝謝你的問題。關於 LEE,關於 Hy's Law 的四個案例,我們當然會與 FDA 和 EMA 進行對話,以找出保護患者利益的最佳方式。我要指出的是,在 CDK4/6 類別中,中性粒細胞減少症是一種靶向效應,並且會定期監測這些患者的嗜中性粒細胞總體血液水平。
So you're going to have a situation here, where we will add-on potentially some additional monitoring with LEE, but we believe we can do this in such a way that it does not create additional patient burden or physician burden. We also, as I mentioned, are doing sub group analyses to look at how we might differentiate LEE from other drugs in the class in terms of efficacy in certain populations and onset of action.
所以你會遇到這樣一種情況,我們可能會用 LEE 增加一些額外的監測,但我們相信我們可以這樣做,不會造成額外的患者負擔或醫生負擔。正如我提到的,我們也正在進行亞組分析,以研究我們如何在特定人群的療效和起效方面將 LEE 與同類藥物區分開來。
- CEO
- CEO
Okay, and the Tasigna, Sprycel?
好的,還有 Tasigna,Sprycel?
- CEO of Novartis Oncology
- CEO of Novartis Oncology
There was a question first on how we are going to commercialize and differentiate versus IBRANCE. Andrew. As Vas said, LEE was the only CDK4/6 to stop at interim analysis in the first-line setting on the basis of the MONALEESA-2 trial.
首先有一個問題是我們將如何商業化並與 IBRANCE 區分開來。安德魯。正如 Vas 所說,LEE 是唯一在 MONALEESA-2 試驗的基礎上在一線環境中停止中期分析的 CDK4/6。
In addition, we believe that the MONALEESA-3 and MONALEESA-7 studies are expected to [grow in the labor] in the [first live] setting. When you combine that to the fact that cancer is really an important focus area for us where we have a long history and experience in the space, as well as on global footprint, we believe that we will be extremely competitive when it comes to launching LEE.
此外,我們認為 MONALEESA-3 和 MONALEESA-7 研究有望在 [首次活體] 環境中 [在分娩中生長]。當您將其與癌症確實是我們在該領域擁有悠久歷史和經驗以及全球足蹟的重要重點領域這一事實相結合時,我們相信在推出 LEE 時我們將極具競爭力.
In terms of the pricing, based on results that were presented at ESMO, we believe that, if approved, Ribociclib will offer an important new treatment option, and as such, will be covered or reimbursed for eligible patients. Finally, your question on the formulary and Tasigna.
在定價方面,根據在 ESMO 上公佈的結果,我們認為,如果獲得批准,Ribociclib 將提供一個重要的新治療選擇,因此,符合條件的患者將獲得承保或報銷。最後,關於處方集和 Tasigna 的問題。
We anticipate that patients on Tasigna who are currently on Tasigna will continue to have access. Indeed, most of the patients that we have in the US on Tasigna are patients who are on insurance and we're talking approximately 90% of the patients. For those patients, those new patients, we will continue to engage with physicians to obtain prior authorization so that the patients who will benefit from Tasigna will receive it.
我們預計目前正在接受 Tasigna 治療的 Tasigna 患者將繼續獲得治療。事實上,我們在美國使用 Tasigna 的大多數患者都是有保險的患者,我們談論的是大約 90% 的患者。對於那些患者,那些新患者,我們將繼續與醫生接觸以獲得事先授權,以便受益於 Tasigna 的患者能夠獲得它。
- CEO
- CEO
Andrew, on your question on large-scale M&A, look, we have been pretty clear that bolt-on strategy is really where we are focused at this point. That doesn't mean we won't do large-scale, but it will have to be very, very attractive for Novartis shareholders if we did. Right now, we're focused on bolt-ons.
安德魯,關於你關於大規模併購的問題,看,我們已經非常清楚,補強戰略才是我們目前關注的重點。這並不意味著我們不會做大規模,但如果我們這樣做的話,它必須對諾華股東非常非常有吸引力。現在,我們專注於補強。
If you look at our pipeline, you look at the underlying growth of this Company, as soon as we get through 2017, which will be the final year of the Glivec patent expiration in Europe, the true growth rate of this Company is going to come through in 2018, 2019 and 2020, so towards the back end of 2017, 2018, 2019 and 2020.
如果你看看我們的管道,看看這家公司的潛在增長,一旦我們度過 2017 年,這將是歐洲 Glivec 專利到期的最後一年,這家公司的真正增長率就會到來到 2018 年、2019 年和 2020 年,然後到 2017 年、2018 年、2019 年和 2020 年末。
That's without the 12 blockbusters that you just saw up there on the list. So on top of that, we're in the position of not having to do large scale M&A, and there are some companies in our sector that will, just from a pipeline standpoint. So we're going to see how things play out, but really focus on bolt-ons at this point.
這還沒有您剛剛在列表中看到的 12 部大片。因此,最重要的是,我們處於不必進行大規模併購的位置,而且我們行業中的一些公司會這樣做,只是從管道的角度來看。所以我們將看看事情如何發展,但此時真正關注的是補強。
- Analyst
- Analyst
Thank you.
謝謝。
Operator
Operator
The next question comes from the line of Matthew Weston from Credit Suisse. Please go ahead.
下一個問題來自瑞士信貸的 Matthew Weston。請繼續。
- Analyst
- Analyst
Many thanks. A number of product-specific questions, please. The first on US respiratory strategy. Paul, you promised us an update at 3Q, so we're all ears. With respect to BAF and the data in SPMS and the potential filing of a single study, Vas, I'd be very interested, Betaseron an SPMS claim in Europe.
非常感謝。請回答一些特定於產品的問題。美國呼吸策略的第一篇。保羅,你答應我們在第三季度更新,所以我們洗耳恭聽。關於 BAF 和 SPMS 中的數據以及單個研究的潛在備案,Vas,我非常感興趣,Betaseron 在歐洲的 SPMS 聲明。
Clearly the EMA has normal policy of you needing to go head-to-head with an active control if something is approved. So should we think of this accelerated single-trial approval strategy as only something relevant for the US?
顯然,EMA 有正常的政策,如果某事獲得批准,您需要與主動控制正面交鋒。那麼我們是否應該將這種加速的單一試驗批准策略視為僅與美國相關?
And then also sticking with filing strategies, AMG 334, Amgen has made it very clear that it's going to file the Phase II-B data to try and get a label in chronic and episodic. Is that something which you think is possible for you ex-US?
然後還堅持歸檔策略,AMG 334,Amgen 已經非常明確地表示它將歸檔 II-B 期數據,以嘗試獲得慢性和偶發性的標籤。你認為這對你不在美國的人來說是可能的嗎?
And then finally, Joe, one big picture. Novartis historically has used US price increases relatively significantly across its specialty portfolio to drive revenue growth. Given the current political environment and the focus of PBMs, in particular, should we be less focused on price going forward, and what impact that might have on growth rates for the Company, particularly in 2017?
最後,喬,一張大圖。諾華歷來利用其專業產品組合中相對顯著的美國價格上漲來推動收入增長。鑑於當前的政治環境和 PBM 的重點,我們是否應該減少對未來價格的關注,以及這可能對公司的增長率產生什麼影響,尤其是在 2017 年?
- CEO
- CEO
Thanks, Matthew. Starting with Paul on US resp.
謝謝,馬修。從美國的保羅開始。
- CEO of Novartis Pharmaceuticals
- CEO of Novartis Pharmaceuticals
Thank you for remembering I committed at the half-year to update on the resp strategy in the US. I said that at the half-year, I was going to look at the scenarios and also there were some variables that we were considering, one of which was how the market would change and how our head-to-head versus Noro the US would play out.
感謝您記得我在半年承諾更新美國的 resp 策略。我說過,在半年內,我將研究各種情況,我們正在考慮一些變量,其中之一是市場將如何變化以及我們與美國諾羅的正面交鋒將如何播出。
We've done the work, we feel comfortable with the choices we have in front of us, but we are going to make you wait a little bit longer till we get the results of the head-to-head. We'll have them in four weeks and very shortly after that we'll share with you what the plans are, but we're well set up now and we will take advantage of how the data lands.
我們已經完成了工作,我們對擺在我們面前的選擇感到滿意,但我們會讓你再等一會兒,直到我們得到正面交鋒的結果。我們將在四個星期內收到它們,之後不久我們將與您分享計劃是什麼,但我們現在已經做好了準備,我們將利用數據的落地方式。
- CEO
- CEO
And Vas?
還有瓦斯?
- Global Head of Drug Development
- Global Head of Drug Development
On BAF312, we went to both CHMP for scientific advice before starting the single Phase III study to ensure that we had a study design that would enable potential licensure of the drug. Then similarly, with the FDA, we did do a special protocol assessment prior to moving forward with the single study. So we feel confident that we've designed the studies in the way that the regulators would expect.
在 BAF312 上,我們在開始單一的 III 期研究之前向 CHMP 尋求科學建議,以確保我們的研究設計能夠實現該藥物的潛在許可。然後類似地,與 FDA 一起,我們在繼續進行單一研究之前確實進行了特殊的協議評估。因此,我們有信心以監管機構期望的方式設計研究。
We'll have those discussions, as I said, over the course of the coming quarter with both EMA and FDA to determine the path forward. On AMG 334, as you rightly note, the chronic migraine is a Phase II-B study, but it is our intention to be fully aligned with the Amgen study submission, and so basically we will be taking for a global package. So in the geographies that we're responsible for, we will plan to submit both for chronic and episodic.
正如我所說,我們將在下個季度與 EMA 和 FDA 進行這些討論,以確定前進的道路。在 AMG 334 上,正如您正確注意到的那樣,慢性偏頭痛是一項 II-B 期研究,但我們打算與 Amgen 研究提交完全一致,因此基本上我們將採用全球一攬子計劃。因此,在我們負責的地區,我們將計劃提交慢性和偶發性的。
- CEO
- CEO
Matthew, on the US pricing environment, if you look at our exposure to US pricing versus our peers, it's less. We're underweight US, and if you look at some of the typical analysis that have been done, it shows that we are less vulnerable if that environment becomes worse. Some of the changes that we've been making to the Company structurally are designed for a more difficult pricing environment, whether it's the US or Europe, right?
馬修,關於美國的定價環境,如果你看看我們對美國定價的敞口與我們的同行相比,它會更少。我們減持美國,如果你看一下已經完成的一些典型分析,它表明如果環境變得更糟,我們就不那麼脆弱了。我們在結構上對公司進行的一些改變是為更困難的定價環境而設計的,無論是美國還是歐洲,對嗎?
The consolidation of our manufacturing sites across all divisions, the global consolidation of global drug development, the movement that we made in some of the divisions in terms of making is sure that we have focused divisions, these are all changes that we have made to ensure that Novartis is able to thrive in whatever environment, whatever pricing environment comes our way, whether it's in the US or Europe. So we are planning for a more difficult environment and that's really why we've made the changes that we have.
我們所有部門的生產基地的整合,全球藥物開發的全球整合,我們在某些部門的製造方面所做的運動確保我們有重點部門,這些都是我們為確保諾華能夠在任何環境中蓬勃發展,無論我們遇到什麼定價環境,無論是在美國還是在歐洲。所以我們正在計劃一個更困難的環境,這就是我們做出改變的真正原因。
In terms of specifically 2017 growth rates, we're putting together budgets as we speak. We're deciding on trade-offs. This is a first year that we're really able to look at the Company as really an integrated Company and making resource allocation decisions in a faster and better way, I believe, so we'll be unveiling that in the January meeting.
具體到 2017 年的增長率,我們正在整理預算。我們正在權衡取捨。我相信,今年是我們真正能夠將公司視為真正的綜合性公司並以更快更好的方式做出資源分配決策的第一年,因此我們將在一月份的會議上公佈這一點。
Operator
Operator
The next question comes from the line of Tim Anderson from Bernstein. Please go ahead.
下一個問題來自伯恩斯坦的蒂姆安德森。請繼續。
- Analyst
- Analyst
Hello. This is Richard Wagner calling for Tim. I had two questions, if you would. One, I wanted to go back to the Roche stake. The report said that, that is on hold. Would it be a correct assumption that the hold is because you didn't like the market price that was offered?
你好。我是理查德·瓦格納,正在找蒂姆。如果你願意的話,我有兩個問題。第一,我想回到羅氏股份。報導說,那是擱置的。假設持有是因為您不喜歡提供的市場價格,這是否正確?
Then the second question on Fovista, one of those pipeline products, as one licensed from Ophthotech. As you know there was some negative data recently with a Regeneron competitor in the class. Wondering how Novartis views that data point. What does that suggest about your own upcoming data read-out? Thank you.
然後是關於 Fovista 的第二個問題,其中一種產品是 Ophthotech 授權的。正如你所知,最近有一些負面數據與 Regeneron 的競爭對手在課堂上。想知道諾華公司如何看待該數據點。這對您自己即將讀出的數據有何暗示?謝謝。
- CEO
- CEO
Okay, Harry, on the Roche stake?
好吧,哈利,在羅氏股份上?
- CFO
- CFO
Actually nothing has changed in the Roche stake. Just because there's a newspaper article, doesn't mean there's anything behind it. So we continue to evaluate the financial investment with the strategic component and everything else has been said by Joe before.
實際上,羅氏股份沒有任何變化。僅僅因為有一篇報紙文章,並不意味著它背後有任何東西。因此,我們繼續評估具有戰略成分的財務投資,喬之前已經說過其他一切。
- CEO
- CEO
And Fovista?
福維斯塔呢?
- Global Head of Drug Development
- Global Head of Drug Development
We saw the Regeneron data, but there's a couple of important points to note. Fovista is an aptamer that actually targets a different sub-type of PDGF, whereas the Regeneron data was a monoclonal antibody targeting a different sub-type of the PDGF. We think there's reasonable pre-clinical data that supports that Fovista is targeting the right ligand that we want to affect for impacting this disease.
我們看到了 Regeneron 的數據,但有幾點需要注意。 Fovista 是一種適配體,實際上靶向不同亞型的 PDGF,而再生元數據是靶向不同亞型 PDGF 的單克隆抗體。我們認為有合理的臨床前數據支持 Fovista 正在針對我們想要影響的正確配體來影響這種疾病。
So we'll look forward to the study results, which we expect in Q4. We feel confident that with the primary endpoint of a four-letter gain, and a gain in that range, will allow us to have a very successful product.
因此,我們將期待第四季度的研究結果。我們相信,有了四個字母增益的主要終點,以及該範圍內的增益,將使我們擁有一個非常成功的產品。
Operator
Operator
The next question comes from the line of Graham Parry from Bank of America Merrill Lynch. Please go ahead.
下一個問題來自美銀美林的 Graham Parry。請繼續。
- Analyst
- Analyst
Great. Thanks for taking my questions. Firstly, on pharma SG&A, you're seeing costs declining year-on-year in the third quarter. I'm just wondering if you could break out how much was FX, what proportion of the increased salesforce costs that you're putting behind Entresto is actually in place in Q3, just to help us understand what that's going to look like as we head into fourth quarter in 2017?
偉大的。感謝您回答我的問題。首先,在製藥 SG&A 方面,您會看到第三季度成本同比下降。我只是想知道您是否可以透露一下 FX 有多少,您在 Entresto 之後投入的增加的銷售人員成本中有多少實際上在第三季度到位了,只是為了幫助我們了解我們前進時會是什麼樣子進入2017年第四季度?
Secondly, on Alcon, you said you won't achieve growth this year, but do you think you can hit the planned exit rate of low single-digits top-line growth? And when, and at what levels, do you expect margins to trough?
其次,關於愛爾康,你說你今年不會實現增長,但你認為你能達到低個位數收入增長的計劃退出率嗎?您預計利潤率何時以及在什麼水平觸底?
Then thirdly, on M&A, Joe you said large scale would have to be attractive. Could you define attractive in terms of what would get you off the fence and into a deal? And thoughts on potential sources of financing there? Clearly you indicated Roche stake could be one? Could also the GSK consumer stake be a further source of financing? Thank you.
第三,關於併購,喬你說大規模必須有吸引力。你能根據什麼能讓你擺脫困境並達成交易來定義吸引力嗎?對那裡的潛在融資來源有何想法?很明顯你表示羅氏股份可能是其中之一?葛蘭素史克消費者的股份也可以成為進一步的融資來源嗎?謝謝。
- CEO
- CEO
Okay, starting with pharma, SG&A?
好的,從製藥、SG&A 開始?
- CEO of Novartis Pharmaceuticals
- CEO of Novartis Pharmaceuticals
So minor FX impact. Overall, Innovative Medicines, SG&A roughly flat, but that hides a significant investment in Cosentyx and Entresto we put in for the back end of the year, some from productivity gains and some sensible decision-making. We'll get to, by the end of Q4, a steady state, plus we've got a few more heads to add in early Q1 for Entresto, about 200, and then you'll know where we stand.
外匯影響很小。總體而言,創新藥物、SG&A 大致持平,但這隱藏了我們在今年年底對 Cosentyx 和 Entresto 的重大投資,其中一些來自生產力提高和一些明智的決策。到第四季度末,我們將達到穩定狀態,而且我們在第一季度初為 Entresto 添加了更多的負責人,大約 200 人,然後你就會知道我們的立場。
- CEO
- CEO
Okay in terms of Alcon sales margins, Mike?
就愛爾康的銷售利潤率而言,邁克?
- CEO of Alcon
- CEO of Alcon
In terms of Alcon, in quarter four, what we're looking at is most likely flat to slightly down versus last year. Again, underlying momentum in the businesses and the actions taken seem like the right ones and we'll see where they read through.
就愛爾康而言,在第四季度,我們所看到的很可能與去年持平或略有下降。同樣,企業的潛在勢頭和所採取的行動似乎是正確的,我們將看到他們通讀的地方。
In terms of the margin, again, as we're facing a declining sales number, and we're pouring on the M&S and R&D to get this thing turned around, it will be tough on the margins. So we are not giving any forecasts for 2017 at this point, but as I said in earlier calls, this will be tough on the margins in the short-term.
就利潤率而言,再次,由於我們面臨銷售數字下降,並且我們正在投入 M&S 和研發以扭轉局面,因此利潤率將很艱難。所以我們目前不對 2017 年做出任何預測,但正如我在之前的電話會議中所說,短期內利潤率會很艱難。
- CEO
- CEO
Graham, just in terms of large-scale M&A, my point was that, that's really not our focus. The focus is really on bolt-ons. Obviously, we have a number of resources that we could use to redeploy if it was something bigger than a bolt-on, but from a financial discipline standpoint, obviously, we would look at synergies needing to be substantial in a way that could ensure that Novartis shareholders would look at any deal and say that, that is a good deal for Novartis shareholders, so we would hold that standard whether it was a bolt-on or something bigger than a bolt-on.
格雷厄姆,就大規模併購而言,我的意思是,那真的不是我們的重點。重點實際上是螺栓固定裝置。顯然,我們有許多資源可以用來重新部署,如果它比螺栓固定更大,但從財務紀律的角度來看,顯然,我們會考慮需要大量的協同作用,以確保諾華股東會審視任何交易並說,這對諾華股東來說是一筆好交易,因此無論是補強還是比補強更大的交易,我們都會堅持這一標準。
Operator
Operator
The next question comes from the line of David Evans from Kepler Cheuvreux. Please go ahead.
下一個問題來自 Kepler Cheuvreux 的 David Evans。請繼續。
- Analyst
- Analyst
Thanks for taking my questions. Just one on BAF312 again. The data looks very good in SPMS. Clearly, as you said, there is very high unmet need and it's a multi-billion dollar market. Could you just talk about the feedback you've had from physicians on this data, especially the level of the efficacy benefit?
感謝您回答我的問題。又是 BAF312 上的一個。 SPMS 中的數據看起來非常好。顯然,正如您所說,未滿足的需求非常高,而且這是一個價值數十億美元的市場。您能否談談醫生對這些數據的反饋,尤其是療效益處的水平?
Then beyond that, how SPMS patients are currently treated. Are they all are mostly still taking largely unproven relapsing therapies and are there any challenges that you think you might face in switching SPMS patients on to BAF312 from any other drug? Essentially any reason why we should not be thinking about BAF as quite likely in the standard of care in SPMS? Thanks.
除此之外,SPMS 患者目前是如何治療的。他們是否大多仍在接受大量未經證實的複發療法?您認為在將 SPMS 患者從任何其他藥物轉為 BAF312 時,您是否可能面臨任何挑戰?基本上我們不應該在 SPMS 的護理標準中考慮 BAF 的任何原因?謝謝。
- Global Head of Drug Development
- Global Head of Drug Development
Thanks for the question. In our feedback from physicians, particularly the investigators that were involved in this study, as well as other experts, there was really a great deal of enthusiasm, because when you look at the primary endpoint, 23% reduction, it's pretty impressive in that it -- the fact that it's consistent at six months out and actually improves.
謝謝你的問題。在我們從醫生那裡得到的反饋中,特別是參與這項研究的研究人員以及其他專家,確實有很大的熱情,因為當你看到主要終點時,減少 23%,這是非常令人印象深刻的,因為它- 它在六個月後保持一致並且實際上有所改善的事實。
Importantly, in both the sub-populations, as I mentioned, who do not have gadolinium enhancing lesions or who are not progressing -- are actively progressing -- or sorry, who are actively progressing, excuse me -- these are populations that really are characteristic of this disease. So it shows that BAF is having the effect on the target population. So a lot of enthusiasm and a lot of support.
重要的是,正如我提到的,在兩個亞群中,沒有钆增強病變或沒有進展——正在積極進展——或者抱歉,正在積極進展,對不起——這些人群確實是本病的特徵。因此,這表明 BAF 正在對目標人群產生影響。如此熱情和支持。
When you think about these patients today, most secondary progressive MS patients have had the disease for 12 to 15 years. They are typically older and they typically had a long-term run with MS, and so many of these patients might be on existing therapies or they may have failed existing therapies.
當您想到今天的這些患者時,大多數繼發性進展型 MS 患者已經患病 12 至 15 年。他們通常年齡較大,並且通常長期患有 MS,因此其中許多患者可能正在接受現有療法,或者他們可能對現有療法無效。
But there's currently no drug that's really widely used or indicated or really has demonstrated an effect. In addition, there's a large installed base of patients who have had MS for a long period of time who are currently not being treated at all with an on-label drug. So we think there's a tremendous opportunity here for BAF312 to capture.
但目前還沒有真正廣泛使用或適應症或真正證明有效的藥物。此外,有大量長期患有多發性硬化症的患者目前根本沒有接受標籤上藥物的治療。因此,我們認為 BAF312 在這裡抓住了巨大的機會。
Operator
Operator
The next question comes from the line of Kerry Holford from BNP Paribas. Please go ahead.
下一個問題來自法國巴黎銀行的 Kerry Holford。請繼續。
- Analyst
- Analyst
Thank you. Kerry Holford, BNP Paribas Exane. Four questions, please, if I can. On firstly Sandoz, we saw a step-down in sales growth in the quarter versus the first half of the year. Price erosion clearly above volume. Is that just a launch timing issue? I wonder if you can talk about your expectations also for price erosion going forwards?
謝謝。法國巴黎銀行 Exane 的克里·霍爾福德 (Kerry Holford)。如果可以的話,請問四個問題。首先是山德士,我們看到本季度的銷售增長與上半年相比有所下降。價格侵蝕明顯高於成交量。這只是一個發佈時間問題嗎?我想知道您是否也可以談談您對未來價格下跌的預期?
Then on Tasigna, you mentioned the growth clearly dropped off in Q3 in the US presumably as a result of that multi-generic Glivec competition. What are your expectations for that brand going forwards? Do you expect that to plateau from here? Can it still grow in the face of generic Glivec? Your thoughts there, please.
然後在 Tasigna,你提到美國第三季度的增長明顯下降,這可能是多仿製藥 Glivec 競爭的結果。您對該品牌未來的發展有何期望?你希望它從這裡穩定下來嗎?面對仿製藥Glivec,它還能增長嗎?請說出你的想法。
As Sandoz stats in the US was also weak in the quarter, I wonder if you could talk about what's driving that? Is it increased competition? Are you losing market share there? Thank you.
由於 Sandoz 在美國的統計數據在本季度也很疲軟,我想知道你是否可以談談是什麼推動了這一點?是不是加劇了競爭?你在那裡失去市場份額嗎?謝謝。
- CEO
- CEO
Okay, Sandoz, Richard?
好的,山德士,理查德?
- CEO of Sandoz
- CEO of Sandoz
Kerry, thanks for the question. With regard to the quarter, actually, if you look across the regions, the regions performed very well, Western Europe up, Central, Eastern Europe, and some of the emerging markets so we had good growth. If you look at the US, which is where you're focused, then we had a very strong quarter through the prior year with, as Harry mentioned, a number of big launches within [AGX] with Exelon Patch, which obviously drove top and bottom line.
克里,謝謝你的提問。關於這個季度,實際上,如果你看一下各個地區,這些地區表現非常好,西歐、中歐、東歐和一些新興市場,所以我們有很好的增長。如果你看看美國,這是你關注的地方,那麼我們在前一年有一個非常強勁的季度,正如 Harry 提到的那樣,[AGX] 內有許多帶有 Exelon Patch 的大型發布,這顯然推動了頂部和底線。
So from a price erosion, we don't see anything unusual in there at all. We see a level of consistency we've seen for the last nine month and 12 months. It really is that launch timing. And so how do I think about pricing going forward? I think about it as the same way. There will obviously be a bit of volatility as competitors come in and launches can be slightly lumpy, but I don't see there's any significant change.
因此,從價格侵蝕來看,我們根本看不到任何異常情況。我們看到了過去 9 個月和 12 個月的一致性水平。確實是那個發佈時間。那麼我如何看待未來的定價呢?我也是這麼想的。顯然會有一些波動,因為競爭對手的加入和發布可能會略有起伏,但我認為沒有任何重大變化。
- CEO
- CEO
And Bruno on Tasigna and Sandostatin?
Bruno 服用 Tasigna 和 Sandostatin?
- CEO of Novartis Oncology
- CEO of Novartis Oncology
First on Tasigna, Tasigna continues to grow very nicely at high single-digit rates, and has retained a strong share, about 47% of the worldwide second-generation TKIs. The vast majority of Tasigna patients are on [menturance] as I said before, and in our experience, they have not switched to generic imatinib when stable.
首先在 Tasigna 上,Tasigna 繼續以高個位數的速度非常好地增長,並保持了強勁的份額,約佔全球第二代 TKI 的 47%。正如我之前所說,絕大多數 Tasigna 患者都在接受 [menturance],根據我們的經驗,他們在穩定後沒有轉用仿製藥伊馬替尼。
The first-line setting is evolving and some payers are focusing on price, but given the deep molecular response achieved with Tasignam we expect that it will remain competitive and continue to be used in those patients that require that product. In terms of Sandostatin, a [land real tide] uptake continues to gradually increase through Ipsen's account-specific contracting strategy.
一線設置正在演變,一些付款人關注價格,但鑑於 Tasignam 取得的深度分子反應,我們預計它將保持競爭力並繼續用於需要該產品的患者。 Sandostatin方面,通過易普生的賬戶特約承包策略,A【陸實潮】吸收量持續逐步增加。
They captured de novo patients outside of carcinoid syndromes. Oncologists have gained comfort with that product and expressing tend to continued usage, capturing new patient starts and switches, but we believe that through our effort and our experience in the field, we will continue to be competitive.
他們捕獲了類癌綜合徵以外的新發患者。腫瘤學家對該產品感到滿意,並表示傾向於繼續使用,捕捉新的患者開始和轉換,但我們相信,通過我們的努力和我們在該領域的經驗,我們將繼續保持競爭力。
Operator
Operator
The next question comes from the line of Florent Cespedes.
下一個問題來自 Florent Cespedes 系列。
- Analyst
- Analyst
Good afternoon, gentlemen. Thank you very much for taking my questions. Three quick ones. First, a follow-up on the respiratory. Paul, could you share with us that if you show positive [attuid] results of a novel drug, you would consider to launch a FLAME-like trial with the US dosage? That's my first question.
下午好,先生們。非常感謝你回答我的問題。三個快速的。首先,對呼吸系統進行隨訪。 Paul,您能否與我們分享一下,如果您對一種新藥顯示出積極的 [attuid] 結果,您會考慮使用美國劑量開展類似 FLAME 的試驗嗎?這是我的第一個問題。
Same question is on Glivec. The product is benefiting from a relatively modest competitive environment in the US. What could be the competitive landscape next year in the US? For the European market, do you expect the same scenario as in the US or do you believe that the competition will be stronger?
同樣的問題是關於 Glivec 的。該產品受益於美國相對溫和的競爭環境。明年美國的競爭格局會怎樣?對於歐洲市場,您預計會出現與美國相同的情況還是認為競爭會更加激烈?
My last question is for Vas, just to come back on LEE. Vas, could you tell us or could you share with us if you see the results of the FALCON trial as a measure element of differentiation of LEE versus Palbo, as you are the first Company, of course, having this combination? Thank you.
我的最後一個問題是 Vas,只是想回到 LEE。 Vas,如果您將 FALCON 試驗的結果視為 LEE 與 Palbo 差異化的衡量要素,您能否告訴我們或與我們分享,因為您當然是第一家擁有這種組合的公司?謝謝。
- CEO
- CEO
Okay, Paul, on respiratory?
好吧,保羅,關於呼吸?
- CEO of Novartis Pharmaceuticals
- CEO of Novartis Pharmaceuticals
Just to confirm, get the data in four weeks on the head-to-head for Noro, and then after there was no plan to launch a FLAME-like study.
只是為了確認,在四個星期內獲得與 Noro 的頭對頭數據,然後在沒有計劃啟動類似 FLAME 的研究之後。
- Analyst
- Analyst
Thank you very much.
非常感謝。
- CEO
- CEO
Sorry go ahead.
對不起,繼續。
- Analyst
- Analyst
That was very clear. Thank you.
這很清楚。謝謝。
- CEO
- CEO
And Bruno, on Glivec?
布魯諾,在格列衛?
- CEO of Novartis Oncology
- CEO of Novartis Oncology
Florent, thank you for the question. On Glivec in the US, so far we've had three competitors on the market and we've managed to maintain over 40% of the Imatinib molecule. Going forward, clearly, there are going to be other generics that are going to enter the market, but we cannot speculate on how many are going to enter the market and what the timing is going to be.
弗洛倫特,謝謝你的提問。在美國的 Glivec 上,到目前為止,我們在市場上有三個競爭對手,我們已經設法保持了超過 40% 的伊馬替尼分子。展望未來,很明顯,還會有其他仿製藥進入市場,但我們無法推測有多少仿製藥進入市場以及具體時間。
But it's clear that as more generics enter the market, it will affect our share of the molecule in the US. With regards to Europe, the dynamic in Europe is very different with various countries having different characteristics. For example, there are some countries that implement mandatory prices when generics are introduced and others don't, so we are working at the moment on preparing for this event on a country-by-country basis and we will provide full-year guidance at quarter four.
但很明顯,隨著更多的仿製藥進入市場,它將影響我們在美國的分子份額。就歐洲而言,歐洲的動態非常不同,各個國家具有不同的特點。例如,有一些國家在引入仿製藥時實施強制性價格,而另一些國家則沒有,所以我們目前正在逐個國家準備這一事件,我們將在 2018 年提供全年指導四分之一。
- CEO
- CEO
Vas, on LEE?
瓦斯,在李?
- Global Head of Drug Development
- Global Head of Drug Development
On LEE, clearly the FALCON study that showed that Fulvestrant was superior to Letrozole in this first-line patient population is a significant factor in our strategy. Now, as we push forward with the MONALEESA-3 study, we believe this is a powerful way for us to differentiate LEE to the other competitor markets because we would be the only Company with first-line data with Fulvestrant in the market.
在 LEE 上,顯然 FALCON 研究表明氟維司群在這一一線患者人群中優於來曲唑,這是我們策略的一個重要因素。現在,隨著我們推進 MONALEESA-3 研究,我們相信這是我們將 LEE 與其他競爭市場區分開來的有力方式,因為我們將成為市場上唯一一家擁有 Fulvestrant 一線數據的公司。
Operator
Operator
The next question comes from the line of Tim Race from Deutsche Bank. Please go ahead.
下一個問題來自德意志銀行的 Tim Race。請繼續。
- Analyst
- Analyst
Thanks for taking my questions. First one on BAF312. Just would like to understand, if you have special protocol assessment agreement there, what's hold you back from filing? Is it the P-value or obviously something else within the primary headlines where we should be knowing about here? And also, do you think it's conceivable that the FDA will ask you to do a relapsing remitting study as well?
感謝您回答我的問題。 BAF312 上的第一個。只是想了解一下,如果您在那裡有特殊的協議評估協議,是什麼阻礙了您提交申請?是 P 值還是我們應該在這裡了解的主要標題中的其他內容?而且,您是否認為 FDA 也會要求您進行複發緩解研究?
Then moving onto Alcon, just to understand the temporary nature of the cost increase on sales and marketing. You talk about it being DTC and a bolus of costs, but obviously, historically, the reason why you're in this situation is because of a lack of investment, so how much of this increasing cost should we see as sticky through 2017 and 2018 and beyond? Thank you.
然後轉向愛爾康,只是為了了解銷售和營銷成本增加的暫時性。你說它是 DTC 和一大筆成本,但顯然,從歷史上看,你處於這種情況的原因是因為缺乏投資,所以我們應該將這種增加的成本中有多少視為在 2017 年和 2018 年具有粘性超越?謝謝。
- CEO
- CEO
Vas?
瓦斯?
- Global Head of Drug Development
- Global Head of Drug Development
BAF312, our agreement with the regulators was on our endpoint study population and the overall design of the study. We did highlight that we would come back to them based on the study results for the potential of a single study submission. But it's important that typically an SPA, we don't get specific regulatory guidance on the disposition of what the FDA may or may not do when we have the final data.
BAF312,我們與監管機構就我們的終點研究人群和研究的總體設計達成協議。我們確實強調,我們會根據研究結果返回給他們,以了解提交單個研究的可能性。但重要的是,通常是 SPA,當我們獲得最終數據時,我們不會獲得有關 FDA 可能或不可以做什麼的處置的具體監管指導。
I would also note that one of the challenges we will have to work through with the agency is the size of our safety database. If you could imagine, if we had, had additional studies, the safety database would be much larger, so that's just going to factor into how they view the benefit/risk on the drug.
我還要指出,我們必須與該機構合作解決的挑戰之一是我們安全數據庫的規模。如果你能想像,如果我們有額外的研究,安全數據庫會更大,所以這只是考慮他們如何看待藥物的益處/風險。
- CEO
- CEO
Mike, on Alcon spending?
邁克,關於愛爾康的支出?
- CEO of Alcon
- CEO of Alcon
With respect to Alcon spending, we're just putting together our plans for 2017. The costs that we've added are variable costs, so as we build our plan then we'll have to consider where we're getting our returns and where we are not getting great returns.
關於愛爾康的支出,我們只是在整理 2017 年的計劃。我們添加的成本是可變成本,因此在製定計劃時,我們必須考慮我們從哪裡獲得回報以及從哪裡獲得回報我們沒有得到豐厚的回報。
Operator
Operator
The next question comes from the line of Eric Le Berrigaud from Bryan, Garnier. Please go ahead.
下一個問題來自 Bryan, Garnier 的 Eric Le Berrigaud。請繼續。
- Analyst
- Analyst
Yes, thank you. Three quick questions, please. First, on Glivec. You're delivering about $0.5 billion in ex-US sales per quarter, which drives us to around $2 billion for the year. Could you tell us maybe out of this $2 billion market how much would be exposed to generics in 2017?
是的,謝謝。請快速回答三個問題。首先,關於格列衛。您每季度實現約 5 億美元的美國以外銷售額,這使我們全年達到約 20 億美元。您能否告訴我們,在這個 20 億美元的市場中,2017 年有多少人會接觸到仿製藥?
Second question, very quickly, how much of Entresto sales reported in the third quarter is in the US? Third, Harry, you commented on the free cash flow for the first nine months; obviously, however, the third quarter goes in another direction. What is behind the difference between net income up by 7% and free cash flow down by 7% in the third quarter? Thank you.
第二個問題,很快,第三季度報告的 Entresto 銷售額有多少來自美國?第三,哈利,你評論了前九個月的自由現金流;然而,顯然,第三季度走向了另一個方向。三季度淨利潤增長7%,自由現金流下降7%,背後究竟有何不同?謝謝。
- CEO
- CEO
Okay, starting with Glivec, Bruno?
好的,從格列衛開始,布魯諾?
- CEO of Novartis Oncology
- CEO of Novartis Oncology
On Glivec, next year, the product will have lost its patent in all of the countries. We're losing it in Europe at the end of December and that will be basically the end of patent protection for Glivec around the world.
關於 Glivec,明年該產品將在所有國家/地區失去其專利。我們將在 12 月底在歐洲失去它,這將基本上結束全球 Glivec 的專利保護。
- CEO
- CEO
And Paul on Entresto?
保羅在 Entresto 上呢?
- CEO of Novartis Pharmaceuticals
- CEO of Novartis Pharmaceuticals
Out of the [$]53 [million], $35 million.
在 [$]53 [百萬] 中,3500 萬美元。
- CEO
- CEO
And Harry on cash flow?
Harry 的現金流呢?
- CFO
- CFO
Eric, thank you for the question. As you know, free cash flow is a bit more volatile than net income or operating income, so a couple of items drove net income. For example, the joint venture net income increase was due to a prior-year restructuring but of course the cash payments from that come via the dividend.
埃里克,謝謝你的提問。如您所知,自由現金流比淨收入或營業收入更不穩定,因此有幾個項目推動了淨收入。例如,合資企業淨收入的增加是由於前一年的重組,但當然現金支付來自股息。
The second piece being on the operating income, prior year was a provision for legal case, the pay out came actually this year. On the quarter three, specifically, we had, for example, some cash payments for intangible assets, which then declined in quarter three by $200 million to free cash flow. Overall, I always recommend on free cash flow to look at the year-to-date numbers because then some of the moves between the net income and the free cash flow items are removed and you have a better picture.
第二塊是營業收入,上年是官司撥備,今年實際支出了。具體來說,在第三季度,我們為無形資產支付了一些現金,然後在第三季度減少了 2 億美元的自由現金流。總的來說,我總是建議在自由現金流量上查看年初至今的數字,因為這樣淨收入和自由現金流量項目之間的一些變動就會被刪除,你會有一個更好的畫面。
Operator
Operator
The next question comes from the line of Vincent Meunier from Morgan Stanley. Please go ahead.
下一個問題來自摩根士丹利的 Vincent Meunier。請繼續。
- Analyst
- Analyst
Thank you for taking my questions. The first one is a follow-up on Alcon. Based on your comments on the operating costs, is it fair to assume that the margin recovery will not come before 2018 and will not be the first priority in 2017?
謝謝你回答我的問題。第一個是愛爾康的後續行動。根據您對運營成本的評論,假設利潤率恢復不會在 2018 年之前出現並且不會成為 2017 年的首要任務是否公平?
The second question is on the OTC joint venture. The contribution has been material this quarter again. Is it fair to assume that you want to keep it as long as possible, and at least until 2018 when the put expires? The last question is a follow-up on the Roche stake, a very simple question, are you waiting for APHINITY read-out or not at all?
第二個問題是關於OTC合資企業。本季度的貢獻再次顯著。假設您想盡可能長時間地保留它是否公平,至少要到 2018 年看跌期權到期?最後一個問題是羅氏股權的後續問題,一個非常簡單的問題,你是在等待 APHINITY 讀出還是根本不讀?
- CEO
- CEO
Okay, starting with Alcon. Mike, on the operating costs, margin recovery?
好的,從愛爾康開始。邁克,關於運營成本,利潤率恢復?
- CEO of Alcon
- CEO of Alcon
If we look, going forward, as I mentioned, top-line recovery is number one. As I also mentioned, we're building our plans as we go forward, so we are not talking about margin recovery at this point; however, from a long-term standpoint, what we did point out in previous calls was that our objective is to get to the industry average in terms of operating income percentage, which is in the low 20%s.
如果我們展望未來,正如我提到的那樣,收入復甦是第一位的。正如我還提到的,我們正在製定我們的計劃,所以我們現在不是在談論利潤率恢復;然而,從長期的角度來看,我們在之前的電話會議中確實指出,我們的目標是在營業收入百分比方面達到行業平均水平,即 20% 左右。
- CEO
- CEO
And Harry?
哈利呢?
- CFO
- CFO
First on the OTC JV, as expected the JV makes good progress. We are satisfied with the continued realization of top- and bottom-line synergies. As you mentioned, we have a put option between three years and 20 years, which would start in March 2018. We are in no hurry to exercise that put option, but of course, we continue to watch.
首先是場外交易合資企業,正如預期的那樣,合資企業取得了良好進展。我們對頂線和底線協同效應的持續實現感到滿意。正如你提到的,我們有一個三年到 20 年的看跌期權,將於 2018 年 3 月開始。我們不急於行使該看跌期權,但當然,我們會繼續觀察。
We are also on the joint venture board to see that it is continued good progress. As you know the target margin of 20%-plus is not yet reached so we expect continued good progress here. On the Roche stake, we are not waiting for APHINITY or anything else. This is simply part of our overall evaluation of capital allocation and our assessment of the value of the stake.
我們也在合資董事會上看到它正在持續取得良好進展。如您所知,尚未達到 20% 以上的目標利潤率,因此我們預計這方面將繼續取得良好進展。在羅氏股權上,我們不是在等待 APHINITY 或其他任何東西。這只是我們對資本配置和我們對股權價值評估的整體評估的一部分。
Operator
Operator
The last question comes from the line of Keyur Parekh from Goldman Sachs. Please go ahead.
最後一個問題來自高盛的Keyur Parekh。請繼續。
- Analyst
- Analyst
Good afternoon and thank you for taking my questions. I've got three big picture ones, please, Joe. The first one, if we were to look out, 12 months out, so third quarter 2017, do you expect the Novartis Corporate structure to be the same as it is today or do you think there might be some additions and deletions to the businesses that you operate in? That's question number one.
下午好,謝謝你回答我的問題。喬,我有三張大照片。第一個,如果我們要看,12 個月後,即 2017 年第三季度,您是否期望諾華公司的公司結構與今天相同,或者您是否認為可能會增加和刪除一些業務你經營?這是第一個問題。
Question number two is, Harry and you both referenced some of the pushes and pulls on 2016 versus 2017. I realize this is still very early in the process, but broadly, should we be thinking about 2017 as a year of growth, decline, or largely flat?
第二個問題是,Harry 和你們都提到了 2016 年與 2017 年相比的一些推動和拉動。我意識到這仍處於早期階段,但總的來說,我們是否應該將 2017 年視為增長、下降或增長的一年?基本持平?
Then thirdly, Joe again, you mentioned some commentary around US pricing and how you are creating a group structure that enables for a harsher pricing environment. If I could just get a sense from you on, over the next two to five years, are you expecting any structural changes to the US pricing environment or do you see more of a slow bleed continuing? Thank you.
第三,喬,你再次提到了一些關於美國定價的評論,以及你如何創建一個能夠應對更嚴酷定價環境的集團結構。如果我能從你那裡得到一些感覺,在接下來的兩到五年內,你是否預計美國定價環境會發生任何結構性變化,或者你是否會看到更多的緩慢流血仍在繼續?謝謝。
- CEO
- CEO
Starting with your first question, if you look out, let's say, a year from now, would the Corporate structure include additions and deletions. The way to answer that question is think about the restructuring that we've done in the last two to three years. Its been quite a bit.
從你的第一個問題開始,如果你看看,比方說,一年後,公司結構是否包括增減。回答這個問題的方法是想想我們在過去兩到三年裡所做的重組。已經很多了。
First it was the portfolio transformation that now has Novartis focused on three divisions. Then we went internal over the last 18 months to create the centralization of services that are going to allow us to take significant cost out over the next few years. So I would say the announcements in terms of what we've done are significant.
首先是投資組合轉型,現在諾華專注於三個部門。然後我們在過去的 18 個月內進入內部,以創建服務的集中化,這將使我們能夠在未來幾年內減少大量成本。所以我想說,就我們所做的事情而言,這些公告意義重大。
We've now created a platform. That platform is going to take time to seed. Global drug development is underway, the manufacturing centralization across divisions is underway, that's going to take quite a bit of effort. We're doing this all because of the external environment. What's coming, whether it's going to be a favorable or unfavorable environment from a health systems standpoint, Novartis is going to be able to weather that,
我們現在已經創建了一個平台。該平台將需要時間來播種。全球藥物開發正在進行中,各部門的製造集中化正在進行中,這將需要付出相當大的努力。我們這樣做都是因為外部環境。即將發生的事情,無論從衛生系統的角度來看是有利還是不利的環境,諾華都將能夠經受住,
In terms of portfolio, specifically, it remains to be seen. We've said, look, on Alcon, we're focused today on turning that business and that's where 100% of our effort is going. In terms of other businesses that we may add or subtract, I wouldn't want to speculate but I would say this is a dynamic process. One of the things that we did learn from the GSK transaction, also with Lilly, is that focus is good on the Company.
具體在投資組合方面,還有待觀察。我們已經說過,看,在愛爾康,我們今天專注於扭轉業務,這就是我們 100% 的努力方向。就我們可能增加或減少的其他業務而言,我不想推測,但我會說這是一個動態過程。我們確實從葛蘭素史克交易以及與禮來公司的交易中學到的一件事是,專注於公司是件好事。
That's why we've made the changes to our divisions. We took pharma out of Alcon and focused it into a medical devices company. We took mature products out of Pharma and put it into Sandoz, so that each unit now is a focused machine that can focus on leading and becoming number one or number two in every sector that they compete in.
這就是我們對部門進行更改的原因。我們將製藥業務從愛爾康剝離出來,專注於一家醫療設備公司。我們把成熟的產品從製藥公司拿出來,放到山德士,這樣每個部門現在都是一台專注的機器,可以專注於在他們競爭的每個領域中領先並成為第一或第二。
In terms of the pushes and the pulls, and how you should think about 2017, Harry said it best: Glivec is a bit better this year than we had expected. If you were expecting modest growth in 2017, then you're going to have to take into account the fact that there's probably more Glivec in 2016 than you had expected and we had expected, so we just ask you to model that.
就推動和拉動以及您應該如何看待 2017 年而言,Harry 說得最好:格列衛今年比我們預期的要好一些。如果您預計 2017 年會適度增長,那麼您將不得不考慮這樣一個事實,即 2016 年 Glivec 的數量可能比您和我們預期的要多,因此我們只要求您對其進行建模。
But really the future of this Company is not about 2017. It's about 2018, 2019, and 2020, because when we get to the end of 2017, and you look at the underlying growth rate of this Company, we absolutely intend -- or our intention is to start the next growth phase of the Company. It's essentially just math as long as we continue to execute the way that we think we're going execute and that wouldn't even include a lot of the 12 blockbusters that are still in our pipeline.
但實際上,這家公司的未來不是 2017 年左右。而是 2018 年、2019 年和 2020 年,因為當我們到 2017 年底時,看看這家公司的潛在增長率,我們絕對打算——或者我們的目的是開始公司的下一個增長階段。只要我們繼續按照我們認為我們將要執行的方式執行,這基本上只是數學,甚至不包括仍在我們管道中的 12 部大片中的很多。
In terms of US pricing, over the next three to five years, I believe that pricing will, number one, become more difficult in the US, but I also think that the US is a place that rewards innovation, and that if you are delivering breakthrough innovation, so if you're first-in-class or you're best-in-class, you're going to do okay in the US pricing environment.
就美國定價而言,在未來三到五年內,我相信定價首先會在美國變得更加困難,但我也認為美國是一個獎勵創新的地方,如果你提供突破性創新,所以如果你是一流的或一流的,你將在美國的定價環境中做得很好。
If you are not first-in-class or best-in-class, you're going to be punished over the next three to five years in a way that you haven't been punished previously. So I think you're going to see a bifurcation of companies that do well in the US and it is going to result in those companies maybe shifting their R&D strategies away from incrementally better drugs now towards more breakthrough therapies.
如果你不是一流的或一流的,你將在未來三到五年內以一種你以前沒有受到過的懲罰的方式受到懲罰。所以我認為你會看到在美國表現良好的公司出現分歧,這將導致這些公司可能將他們的研發戰略從現在逐漸更好的藥物轉向更具突破性的療法。
Listen, I'd like to thank everybody for attending the call and we look forward to giving you an update at our full-year results on January 25. Thank you very much.
聽著,我要感謝大家參加電話會議,我們期待在 1 月 25 日向您提供我們全年業績的最新情況。非常感謝。
Operator
Operator
Thank you for joining today's conference. You may now replace your handsets.
感謝您參加今天的會議。您現在可以更換手機。