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, and welcome to the Novartis Q4 and Full Year 2019 Results Release Conference Call and Live Audio Webcast.
早上好,下午好,歡迎來到諾華公司 2019 年第四季度和全年業績發布會電話會議和現場音頻網絡直播。
(Operator Instructions) And the conference is being recorded.
(操作員說明)會議正在錄製中。
(Operator Instructions) A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends.
(操作員說明)電話會議的錄音,包括問答環節,將在電話會議結束後不久在我們的網站上提供。
(Operator Instructions)
(操作員說明)
With that, I would now like to hand the conference over to Mr. Samir Shah, Global Head of Investor Relations.
有了這個,我現在想把會議交給全球投資者關係主管 Samir Shah 先生。
Please go ahead, sir.
請繼續,先生。
Samir Shah - Global Head of IR
Samir Shah - Global Head of IR
Hello, and welcome, everybody.
大家好,歡迎大家。
Thank you for participating in our full year and quarter 4 2019 investor call.
感謝您參加我們的 2019 年全年和第四季度投資者電話會議。
Before I start, I'll read you the safe harbor statement.
在我開始之前,我會讀給你安全港聲明。
The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors.
今天提供的信息包含涉及已知和未知風險、不確定性和其他因素的前瞻性陳述。
These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.
這些可能導致實際結果與此類陳述所表達或暗示的任何未來結果、業績或成就存在重大差異。
Please refer to the company's Form 20-F on file with the U.S. Securities and Exchange Commission for a description of some of these factors.
請參閱公司在美國證券交易委員會存檔的 20-F 表格,了解其中一些因素的描述。
If you then turn to Slide 3 in our investor presentation, you'll see the list of participants.
如果您隨後轉到我們的投資者演示文稿中的幻燈片 3,您將看到參與者列表。
So in the room, we have Vas Narasimhan, the Chief Executive Officer; Harry Kirsch, the CFO; Marie-France Tschudin, who's the President of Novartis Pharmaceuticals; Susanne Schaffert, President of Novartis Oncology; John Tsai, Head of Global Drug Development and the CMO; Richard Saynor, who's the CEO of Sandoz; and Shannon Klinger, the Group General Counsel.
會議室裡有首席執行官 Vas Narasimhan;首席財務官 Harry Kirsch; Marie-France Tschudin,諾華製藥總裁; Susanne Schaffert,諾華腫瘤學總裁; John Tsai,全球藥物開發主管兼首席營銷官;山德士首席執行官 Richard Saynor;和集團總法律顧問 Shannon Klinger。
I'm going to hand across to Vas just in a minute or 2.
我將在一兩分鐘內轉交給 Vas。
(Operator Instructions)
(操作員說明)
With that, I'll hand across to Vas.
有了這個,我將交給瓦斯。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Great.
偉大的。
Thank you, Samir, and thank you all for joining today's full year results conference call.
謝謝你,薩米爾,謝謝大家參加今天的全年業績電話會議。
So if we move to Slide 5, as you saw in 2019, we really delivered an outstanding performance across the company.
因此,如果我們轉向幻燈片 5,正如您在 2019 年所看到的那樣,我們確實在整個公司中取得了出色的表現。
And I think the big reason for that is we've had a clear strategy, and we're executing against that strategy.
我認為這樣做的主要原因是我們有一個明確的戰略,我們正在執行該戰略。
Clearly we want to be a focused medicines company powered by advanced therapy platforms and data science.
顯然,我們希望成為一家以先進治療平台和數據科學為動力的專注醫藥公司。
We're focusing the company, and we're delivering against each of our 5 priorities, which I'll take in turn over the course of this presentation.
我們專注於公司,並針對我們的 5 個優先事項中的每一個進行交付,我將在本演示文稿的過程中輪流處理這些事項。
So going to Slide 6. When you look at the last 2 years, we've executed now over $70 billion of transactions, both to focus the company and build up our presence in strategic areas, including building a presence in cell and gene therapies and radioligand therapy, now with inclisiran, a presence in RNA therapeutics.
所以轉到幻燈片 6。回顧過去 2 年,我們現在已經執行了超過 700 億美元的交易,既是為了專注於公司,又是為了建立我們在戰略領域的影響力,包括在細胞和基因治療領域建立影響力,以及放射性配體療法,現在與 inclisiran 一起出現在 RNA 療法中。
Altogether, a broad-based medicines portfolio, which we believe is the largest medicines company purely focused on the discovery and broad access to medicines in the world.
總而言之,這是一個基礎廣泛的藥品組合,我們認為這是最大的藥品公司,純粹專注於世界上藥物的發現和廣泛獲取。
We also continue to execute our M&A strategy to build our deeper therapeutic expertise and therapeutic depth in areas like ophthalmology and cardiovascular disease.
我們還將繼續執行我們的併購戰略,以在眼科和心血管疾病等領域建立更深層次的治療專業知識和治療深度。
So we feel good about this dynamic and look forward to continuing a strategy of bolt-on M&A for the years to come, depending on the quality of the assets we identify.
因此,我們對這種動態感覺良好,並期待在未來幾年繼續實施補強併購戰略,具體取決於我們確定的資產質量。
Moving to Slide 7. When you look at innovation, one of our key pillars, I think we demonstrated this year that we are on the right track and really have developed the depth of a pipeline that can enable us to grow in the long term.
轉到幻燈片 7。當您看到我們的關鍵支柱之一創新時,我認為我們今年證明了我們走在正確的軌道上,並且確實已經開發了可以使我們長期增長的管道深度。
When you think about the scale of the portfolio that we demonstrated at our R&D day, we have scale and depth across all of our key therapeutic areas from Phase I to Phase III.
當您考慮我們在研發日展示的產品組合的規模時,我們在從 I 期到 III 期的所有關鍵治療領域都有規模和深度。
When you look at the replacement power of our pipeline, when we look at the data from Evaluate Pharma, we see a profile where we lead the industry in replacement power between 2019 and 2024.
當您查看我們管道的替代能力時,當我們查看 Evaluate Pharma 的數據時,我們會看到我們在 2019 年至 2024 年期間引領行業替代能力的概況。
And we continue to focus on building a deeper pipeline in advanced therapies, 16 programs now in clinical development as well as a focus on first-in-class and first-in-indication, with 90% now of the portfolio with that profile.
我們將繼續專注於在先進療法方面建立更深層次的管道,目前有 16 個項目處於臨床開發階段,並專注於一流和首次適應症,目前 90% 的產品組合具有該配置文件。
Now moving to Slide 8. 2019 was truly a breakthrough year for that innovation with 5 NME approvals, which we believe is a record for a company in the industry, at least in recent years, 6 if you include 1 of our tropical medicine approvals, 30 major submissions around the world and 30 clinical data readouts.
現在轉到幻燈片 8。2019 年確實是該創新突破性的一年,獲得了 5 項 NME 批准,我們認為這是該行業公司的記錄,至少在最近幾年,如果您包括我們的 1 項熱帶藥物批准,則為 6,全球30個主要提交和30個臨床數據讀數。
But 2019 was the year we showed that we have the depth and breadth of a portfolio that can grow for the long term.
但 2019 年是我們展示我們擁有可以長期增長的投資組合的深度和廣度的一年。
So very pleased with that, and we'll go through in a little more detail later on in the call how we're performing on some of these launches.
對此非常滿意,稍後我們將在電話會議中更詳細地介紹我們在其中一些發布中的表現。
Now moving to Slide 9. When you look at catalysts for 2020, another full year of catalysts, major approvals, including the expected approval of ofatumumab, which we filed in December and used a priority review voucher.
現在轉到幻燈片 9。當您查看 2020 年的催化劑時,又是一整年的催化劑,主要批准,包括預期的 ofatumumab 批准,我們在 12 月提交並使用了優先審查憑證。
We also, of course, have the planned filing shortly of Entresto and have passed the filed -- the planned approval of hopefully QVM and QMF in asthma, capmatinib in lung cancer, Cosentyx non-radiographic axSpA where we also used a priority review voucher; and inclisiran, where we've now filed in both the U.S. and the EU, both with expected action dates in -- over the course of 2020.
當然,我們也計劃在不久的將來提交 Entresto 並且已經通過了申請——希望 QVM 和 QMF 治療哮喘、capmatinib 治療肺癌、Cosentyx 非放射照相 axSpA 的計劃批准,我們還使用了優先審查憑證;和 inclisiran,我們現在已經在美國和歐盟提交了申請,預計行動日期都在 2020 年。
Also, a number of major readouts across the portfolio.
此外,整個投資組合的一些主要讀數。
Highlights include the Lu-PSMA, the radioligand therapy asset in prostate cancer as well as a number of others which you can see here on the slide.
亮點包括 Lu-PSMA、前列腺癌的放射性配體治療資產以及您可以在幻燈片上看到的其他一些資產。
And then as we tried to highlight to you in the R&D day, a number of Phase III starts.
然後,正如我們試圖在研發日向您強調的那樣,許多第三階段開始了。
Our mid-stage pipeline now is rapidly advancing, and we'll look forward to giving you updates on how that portfolio evolves over the course of the year.
我們的中期管道現在正在迅速推進,我們期待為您提供有關該產品組合在一年中如何發展的最新信息。
So moving to Slide 10.
所以轉到幻燈片 10。
We also have a big focus on China, as I think you're seeing across the sector.
我們也非常關注中國,正如我認為你在整個行業中看到的那樣。
We would like to highlight a few points when you look at our profile in China.
當您查看我們在中國的簡介時,我們想強調幾點。
We had 13 NME approvals over the past 5 years with 22 NRDL listings since 2017, showing we're really pivoting to a much more innovative portfolio across our China business.
自 2017 年以來,我們在過去 5 年中獲得了 13 項 NME 批准,其中 22 項 NRDL 上市,這表明我們確實在中國業務中轉向更具創新性的投資組合。
When you look forward, we expect now to have 50 NDA approvals between 2020 and 2024.
展望未來,我們現在預計在 2020 年至 2024 年期間將獲得 50 個 NDA 批准。
That's a doubling of the rate we've had over recent years.
這是我們近年來的速度的兩倍。
And our goal is to deliver greater than 90% of our 2024 and beyond China submissions simultaneously with global submissions.
我們的目標是在 2024 年及以後提交超過 90% 的中國和全球提交的作品。
We expect to have a profile in China.
我們希望在中國擁有自己的形象。
Our total sales in China are in the range of $2.2 billion.
我們在中國的總銷售額為 22 億美元。
And our aspiration is to double that business over the coming 5 years.
我們的願望是在未來 5 年內將該業務翻一番。
So a big focus on China and look forward to keeping you up-to-date on that profile as the year progresses.
因此,我們將重點放在中國,並期待隨著時間的推移讓您及時了解該概況。
So moving to Slide 11, moving to operational excellence.
所以轉向幻燈片 11,轉向卓越運營。
We delivered a strong performance in 2019, as you saw from the results release.
正如您從結果發布中看到的那樣,我們在 2019 年取得了強勁的表現。
Harry will go through these numbers in a bit more detail.
哈利將更詳細地介紹這些數字。
But some of the highlights, I think, strong sales growth with 9% sales growth in constant currencies.
但我認為,其中一些亮點是強勁的銷售增長,按固定匯率計算,銷售額增長了 9%。
We're delivering on the margin expansion, with 1.8% margin expansion in IM.
我們正在實現利潤率擴張,IM 利潤率擴張 1.8%。
And I'll talk a little bit more about that on the next slide.
我將在下一張幻燈片上多談一點。
And I think we're delivering as well a strong shareholder return profile.
而且我認為我們也提供了強大的股東回報概況。
When you look at the 1-year TSR, 22.3%, but both -- also when you look at the 2-year, 3-year TSRs as well, we're delivering as well nice returns for our shareholders.
當您查看 1 年期股東總回報率為 22.3%,但兩者兼而有之時 - 以及當您查看 2 年、3 年期股東總回報率時,我們也為我們的股東提供了可觀的回報。
And we, of course, appreciate your confidence in Novartis.
當然,我們感謝您對諾華的信任。
Now moving to Slide 12, to go a little bit deeper on the operational performance.
現在轉到幻燈片 12,以更深入地了解運營績效。
When you look at our growth drivers, strong performance across the growth drivers, Cosentyx and Entresto growing well.
當您查看我們的增長驅動力時,Cosentyx 和 Entresto 的增長驅動力表現強勁。
Marie-France will go into that in a bit more detail.
Marie-France 將更詳細地介紹這一點。
Zolgensma, I'll cover in a moment.
Zolgensma,我稍後會介紹。
And then as well across the Oncology portfolio, Lutathera, Kisqali, Kisqali really now picking up momentum.
然後在整個腫瘤學產品組合中, Lutathera 、 Kisqali 、 Kisqali 現在真的在加速發展。
Susanne will tell you a bit more about that.
蘇珊娜會告訴你更多關於這一點的信息。
So when you look across that, the left-hand side of the slide, you see a broad set of assets that are continuing to grow well in market.
因此,當您查看幻燈片的左側時,您會看到一系列廣泛的資產,這些資產在市場上繼續保持良好增長。
And we're a company with 15 blockbusters in our in-line portfolio and that gives us that diversity and strength to keep growing in the long term.
我們是一家在我們的在線投資組合中擁有 15 部大片的公司,這為我們提供了多樣性和長期保持增長的實力。
When you look at growth drivers as a percent of recent launches, we're now up to 35% exiting 2019, and we expect that number to continue to grow over the coming years.
當您將增長驅動因素視為最近發布的百分比時,我們現在在 2019 年退出時高達 35%,我們預計該數字將在未來幾年繼續增長。
So moving to Slide 13.
所以轉到幻燈片 13。
When you look at the profile of the company for the next 3 years, 15 ongoing or upcoming major launches.
當您查看公司未來 3 年的概況時,有 15 項正在進行或即將推出的主要產品。
This will be a huge focus for us in 2020, driving the 2019 launches which are already in progress and now really focusing on preparing for the 2020 and 2021 launches.
這將是我們 2020 年的一大重點,推動已經在進行中的 2019 年發射,現在真正專注於為 2020 年和 2021 年的發射做準備。
And you'll hear more about that from my colleagues later on in the call.
稍後您將在電話會議中從我的同事那裡聽到更多關於此的信息。
So moving to Slide 14.
所以轉到幻燈片 14。
I wanted to say a word on Zolgensma performance in 2019.
我想談談 Zolgensma 在 2019 年的表現。
We had a strong launch.
我們推出了強勁的產品。
Full year sales was at $361 million.
全年銷售額為 3.61 億美元。
So very good performance.
所以表現非常好。
When you look at the patients treated commercially, we're roughly at a rate of about 100 patients per quarter, 100 for Q3 and 200 now at the year-end.
當您查看接受商業治療的患者時,我們大致以每季度約 100 名患者的速度,第三季度為 100 名,現在年底為 200 名。
We would expect in the U.S. to be largely at that rate of 100 patients a quarter until we have approval in Europe to have the next inflection point and then eventually the intrathecal approval as well, which I'll speak to in a moment.
我們預計美國將在很大程度上以每季度 100 名患者的速度進行,直到我們在歐洲獲得批准以達到下一個拐點,然後最終也獲得鞘內批准,我稍後會談到。
Commercial lives were up to a 97% coverage.
商業生活的覆蓋率高達 97%。
Medicaid lives, we're at over 50% coverage.
醫療補助生活,我們的覆蓋率超過 50%。
Newborn screening continues to tick up, and we've continued heavily -- to be heavily focused on driving newborn screening.
新生兒篩查繼續增加,我們繼續大力 - 重點關注推動新生兒篩查。
And importantly, we have 99% of patients approved now for reimbursement if they're on label for Zolgensma.
重要的是,如果他們在 Zolgensma 的標籤上,我們現在有 99% 的患者被批准報銷。
Now some of the next steps for the product, the intrathecal formulation, clinical hold, we're working on a submission to FDA for a data package to hopefully resolve the clinical hold, then continue the regulatory discussions.
現在該產品的一些後續步驟,鞘內製劑,臨床保留,我們正在向 FDA 提交數據包以希望解決臨床保留,然後繼續監管討論。
And we continue to hope to file the intrathecal formulation this year.
我們繼續希望今年提交鞘內製劑。
CHMP positive opinion, we anticipate in Q1 of this year.
CHMP 正面意見,我們預計在今年第一季度。
With respect to Japan, we anticipate an approval in the first half of this year.
關於日本,我們預計今年上半年會獲得批准。
And I would say conversations both into Europe and Japan are going very well.
我想說的是,歐洲和日本的對話進展順利。
And then we also anticipate decisions in other markets around the world, including Switzerland, Canada, Australia, Brazil, and as well as a number of countries in the Middle East.
然後,我們還預計全球其他市場的決策,包括瑞士、加拿大、澳大利亞、巴西以及中東的一些國家。
These will be additional areas of potential future growth for the medicine.
這些將是該藥物未來潛在增長的其他領域。
So Zolgensma is delivering on the promise of bringing a transformational gene therapy to children.
因此,Zolgensma 正在兌現為兒童帶來轉化基因療法的承諾。
We look forward to continuing to progress expanding its application in more patient populations in more geographies in the year to come.
我們期待在來年繼續在更多地區擴大其在更多患者人群中的應用。
So moving to Slide 15.
所以轉到幻燈片 15。
On the margins, we've guided -- the last time we spoke about this, Q4 of last year, that we expect to have reached the mid-30s in the near term, and you can see us already getting close to that with 33.5% exiting 2019 and the mid- to high 30s in the medium term.
在邊緣,我們已經指導 - 我們上次談到這個,去年第四季度,我們預計在短期內已經達到 30 年代中期,你可以看到我們已經接近 33.5退出 2019 年和中期 30 年代中高點的百分比。
One important thing to note about our margin guidance is we would expect to achieve these margins independent of when a potential Gilenya LOE occurs.
關於我們的保證金指導需要注意的一件重要事情是,我們希望實現這些保證金,而與潛在的 Gilenya LOE 發生時間無關。
And that's really driven by a combination of strong sales momentum of our growth drivers, productivity programs, which I'll talk about in a moment, as well as excellent resource allocation from our older brands to newer launches.
這實際上是由我們增長動力的強勁銷售勢頭、生產力計劃(我稍後會談到)以及從我們的老品牌到新產品的出色資源分配共同推動的。
And with that, we're able to offset generic erosions as well as any launch investments we need for upcoming launches, including the newly acquired inclisiran asset.
有了這個,我們能夠抵消通用侵蝕以及我們即將推出的任何發射投資,包括新收購的 inclisiran 資產。
So moving to Slide 16.
所以轉到幻燈片 16。
I just wanted to say a word about the transformation we're advancing in NTO and NBS.
我只是想談談我們正在 NTO 和 NBS 推進的轉型。
With respect to manufacturing, we're well on our way of our goal of a consolidated footprint that's much more focused on high-end technologies.
在製造方面,我們正在朝著更加專注於高端技術的整合足蹟的目標邁進。
We also are advancing our efforts in procurement and manufacturing, really reducing the excess inventories that we're holding and also deploying data in digital much more aggressively across the manufacturing network.
我們也在推進我們在採購和製造方面的努力,真正減少我們持有的過剩庫存,並在整個製造網絡中更積極地部署數字數據。
In NBS, we are on track now with respect to our movement of roles to our global service centers.
在 NBS,我們現在正在將角色轉移到我們的全球服務中心。
We've been able to take a number of actions to consolidate our footprint as well as consolidate our overall real estate operations.
我們已經能夠採取一些行動來鞏固我們的足跡並鞏固我們的整體房地產業務。
We have a new Chief Procurement Officer, who has now been in the role for a number of months, already optimizing our top 100 suppliers.
我們有一位新的首席採購官,他現在已經擔任了幾個月的職務,已經優化了我們的前 100 家供應商。
So all of this taken together is enabling us to be on track to deliver our goal of $2 billion of savings by the end of 2020.
因此,所有這些加在一起使我們能夠按計劃實現到 2020 年底節省 20 億美元的目標。
And we expect these efforts to deliver an additional $1.5 billion of savings in the medium term, to contribute to that margin expansion I showed you on the earlier slide.
我們預計這些努力將在中期內額外節省 15 億美元,以促進我在上一張幻燈片中向您展示的利潤率增長。
Now moving to Slide 17.
現在轉到幻燈片 17。
Sandoz also had a great 2019.
山德士在 2019 年也表現出色。
They delivered accretive growth.
他們實現了增長。
You saw 2% global sales, 7% ex U.S., 16% in biopharmaceuticals.
您看到全球銷售額為 2%,美國以外為 7%,生物製藥為 16%。
Importantly, excellent leverage on the P&L with 10% core operating income growth.
重要的是,以 10% 的核心營業收入增長對損益表的出色槓桿作用。
This is in large part due to the focusing on our key strategy that Richard and his team have put in place, focusing on a core generics business, trying to be a great generics company, both in oral solid and injectables and biosimilars, focusing in on key geographies where we think we can build strong long-term positions.
這在很大程度上是由於 Richard 和他的團隊已經制定了我們的關鍵戰略,專注於核心仿製藥業務,努力成為一家偉大的仿製藥公司,在口服固體和注射劑和生物仿製藥領域,專注於我們認為我們可以建立強大的長期頭寸的關鍵地區。
We have the #1 position in the EU.
我們在歐盟排名第一。
In Japan, we closed the -- or are in the process of closing the Aspen acquisition and are confident we can continue to build our business in Japan.
在日本,我們完成了或正在完成對 Aspen 的收購,並有信心繼續在日本建立我們的業務。
And in the U.S., we're stabilizing the business.
在美國,我們正在穩定業務。
We expect a closure of the transaction with Aurobindo in Q1 of this year, which will allow us then to focus on our hospital and biosimilars businesses.
我們預計與 Aurobindo 的交易將在今年第一季度完成,這將使我們能夠專注於我們的醫院和生物仿製藥業務。
We're on track as well to have an autonomous Sandoz within Novartis for the start of 2021, focused very much in the manufacturing organization.
我們也有望在 2021 年初在諾華(Novartis)內擁有自主的山德士(Sandoz),非常專注於製造組織。
And we continue to advance our broad portfolio of biosimilars.
我們繼續推進我們廣泛的生物仿製藥產品組合。
So very pleased with the progress we're making in Sandoz.
對我們在 Sandoz 取得的進展非常滿意。
If you go to the next slide.
如果您轉到下一張幻燈片。
Now I just wanted to touch on our data and digital transformation, culture and ESG.
現在我只想談談我們的數據和數字化轉型、文化和 ESG。
Across all of the key pillars of our digital transformation, we are now beginning to really see this take hold at the company.
在我們數字化轉型的所有關鍵支柱中,我們現在開始真正看到這在公司中佔有一席之地。
I think it's fundamentally transforming how we operate.
我認為它從根本上改變了我們的運營方式。
We're scaling 12 digital, what we call lighthouse projects, which are enabling us to transform ourselves, whether it's in our development and trial operations, manufacturing, in our sales force.
我們正在擴展 12 個數字化項目,我們稱之為燈塔項目,這些項目使我們能夠改變自己,無論是在我們的開發和試運營、製造還是我們的銷售隊伍中。
The idea is that we have AI and data science powering our decision-making wherever relevant at the company.
我們的想法是,我們有人工智能和數據科學來支持我們在公司相關的任何地方的決策。
We're making Novartis digital.
我們正在使諾華數字化。
We have over 1,500 associates now in digital and data science at the company.
我們現在在公司擁有 1,500 多名從事數字和數據科學的員工。
We also are getting broad interest in learning programs on digital at Novartis.
我們也對諾華的數字學習項目產生了廣泛的興趣。
We're working to become a key partner in the start-up tech ecosystem.
我們正在努力成為初創技術生態系統中的重要合作夥伴。
We have biomes which we have launched in a number of cities around the world, which allow start-ups to work closely with Novartis.
我們擁有在全球多個城市推出的生物群落,讓初創企業能夠與諾華密切合作。
And lastly, we're working on bold moves.
最後,我們正在採取大膽的舉措。
We've made a bold collaboration with Microsoft on an AI innovation lab in R&D.
我們與微軟在研發領域的人工智能創新實驗室進行了大膽的合作。
We're partnering with Amazon Web Services to transform our technical operations as well as our procurement operation, and working in China with Tencent in areas like heart failure.
我們正在與 Amazon Web Services 合作,以轉變我們的技術運營和採購運營,並在中國與騰訊在心臟衰竭等領域開展合作。
I expect that in the coming years you will see the tangible impact of these efforts on both our top and bottom line.
我希望在未來幾年中,您會看到這些努力對我們的收入和利潤產生了切實的影響。
Now if you move to the next slide.
現在,如果您轉到下一張幻燈片。
Also on culture change, we continue to believe culture will be the key driver of our long-term performance, truly creating an inspired, curious and unbossed organization.
同樣在文化變革方面,我們仍然相信文化將成為我們長期業績的關鍵驅動力,真正創造一個充滿靈感、好奇和無主的組織。
There's a broad range of initiatives which you see here on the slide.
您可以在幻燈片上看到範圍廣泛的舉措。
I won't go through all of them.
我不會遍歷所有這些。
But I think [it's] just to give you a sense that we take this very seriously at the executive committee level.
但我認為 [it's] 只是為了讓你感覺到我們在執行委員會層面非常重視這一點。
We are working diligently to drive this through the organization, whether it's getting our people more connected with the purpose, whether it's enabling learning and growth across the company and whether it's developing leaders who are more self-aware and able to lead it in a powered, unbossed way.
我們正在努力推動整個組織實現這一目標,無論是讓我們的員工與目標更緊密地聯繫起來,還是促進整個公司的學習和成長,以及是否培養更有自我意識並能夠以強有力的方式領導它的領導者,無主的方式。
We're quite committed to this and we believe in the long run, for our long-run investors it will truly pay off.
我們非常致力於這一點,我們相信從長遠來看,對於我們的長期投資者來說,這將真正得到回報。
On the next slide, if you now turn to our efforts to build trust with society.
在下一張幻燈片上,如果您現在轉向我們與社會建立信任的努力。
Many of you attended our ESG Investor Day last fall, and we continue to progress against our aspirations.
去年秋天,你們中的許多人參加了我們的 ESG 投資者日,我們繼續朝著我們的願望前進。
In ethical standards, we rolled out a new program to really tackle third-party risk management at scale.
在道德標準方面,我們推出了一項新計劃,以真正大規模解決第三方風險管理問題。
In pricing and access, we've outlined a new approach in Sub-Saharan Africa, where our entire Sub-Saharan Africa business is now under a single entity whose goal is to maximize access without having to focus on profits, and really just say how can we build health care systems and access in Africa.
在定價和訪問方面,我們在撒哈拉以南非洲概述了一種新方法,我們的整個撒哈拉以南非洲業務現在都在一個單一的實體下,其目標是在不必關注利潤的情況下最大化訪問,實際上只是說明如何我們能否在非洲建立醫療保健系統和准入。
In Global Health, we are pioneering work in sickle cell disease in Ghana and across Sub-Saharan Africa to really tackle for the first time a chronic genetic disease at scale in the region.
在全球健康方面,我們正在加納和整個撒哈拉以南非洲地區開展鐮狀細胞病方面的開創性工作,以首次真正在該地區大規模解決慢性遺傳病。
And on Corporate Citizenship, we have now reached 44% women in management, and our goal continues to be to get to 50%, and we're on track to do so.
在企業公民方面,我們現在已經達到了 44% 的女性管理層,我們的目標仍然是達到 50%,而且我們正朝著這個目標前進。
So moving to Slide 21.
所以轉到幻燈片 21。
I wanted to highlight that, with our ESG approach, we are not just setting ambitious targets for the long run, but we're also embedding this into our operations.
我想強調的是,通過我們的 ESG 方法,我們不僅設定了雄心勃勃的長期目標,而且還將其嵌入到我們的運營中。
We have a set of ESG targets for 2020.
我們有一套 2020 年的 ESG 目標。
We will -- these are embedded in my scorecards for 2020 as well as the executive team.
我們將——這些都嵌入到我的 2020 年記分卡以及執行團隊中。
We will transparently report on them, so really report on our progress in each of these areas against our longer-term goals.
我們將透明地報告它們,因此根據我們的長期目標真正報告我們在每個領域的進展。
They're tracked at a Trust and Reputation Committee that I chair, linked to -- [with] compensation and transparently disclosed.
他們在我主持的信任和聲譽委員會進行跟踪,與 - [with] 補償和透明披露相關聯。
And if you go to the next slide, one thing I want to highlight is you can find a tremendous amount of detail at the Novartis in Society Report.
如果您轉到下一張幻燈片,我想強調的一件事是您可以在諾華公司的社會報告中找到大量細節。
We also have published a dynamic index which goes through all of the key ESG metrics, links them to where you can find the information you need for Novartis.
我們還發布了一個動態索引,其中包含所有關鍵 ESG 指標,將它們鏈接到您可以找到諾華所需信息的位置。
This is both to enable the ESG rating agencies, as well as your own ESG groups, to be able to find the information they need about the company.
這既是為了讓 ESG 評級機構以及您自己的 ESG 小組能夠找到他們需要的有關公司的信息。
And if you can't find it, please let us know.
如果找不到,請告訴我們。
When you look at some of the things we're committed to, they include reducing the launch time lag for innovative medicines to less than 3 months for low- and middle-income countries, versus what we see in U.S. and Europe.
當您查看我們承諾的一些事情時,它們包括將低收入和中等收入國家的創新藥物的推出時間延遲減少到不到 3 個月,而我們在美國和歐洲看到的情況。
We've committed to get to carbon neutrality in our own operations by 2025 as well as tackle our third-party Scope 3 carbon emissions, delivering on the UN Equal Pay for Equal Work and Gender Equity goals, as I said, addressing major areas in global health.
我們承諾到 2025 年在我們自己的運營中實現碳中和,並解決我們的第三方範圍 3 碳排放問題,如我所說,實現聯合國同工同酬和性別平等目標,解決主要領域全球健康。
So a very -- a concerted effort, one we deeply believe in, I'm personally committed to, and we hope to show progress over the course of the year.
因此,這是一項我們深信不疑的齊心協力,我個人致力於,我們希望在這一年中取得進展。
So moving to the next slide.
所以轉到下一張幻燈片。
I just want to close before handing it to Marie-France, that we believe that, in total, when you look at the portfolio of Novartis, we're well positioned for sustained long-term growth.
我只想在把它交給 Marie-France 之前結束,我們相信,總的來說,當你看看諾華的投資組合時,我們已經做好了持續長期增長的準備。
We have a strong set of end-market growth drivers.
我們擁有強大的終端市場增長動力。
We have a great set of 15 ongoing or upcoming major launches, a broad set of novel assets that we highlighted in our R&D day as well as a range of new indications for products like Cosentyx, Beovu, Piqray, amongst others.
我們有 15 個正在進行或即將推出的重大產品,我們在研發日強調的一系列廣泛的新資產,以及 Cosentyx、Beovu、Piqray 等產品的一系列新適應症。
We believe this will sustain our growth over the medium to long term, and we'll look forward to delivering these important medicines for the world over the coming years.
我們相信這將維持我們的中長期增長,我們期待在未來幾年為世界提供這些重要藥物。
So with that, I will hand it over to Marie-France.
因此,我將把它交給 Marie-France。
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
So good afternoon to all of you.
大家下午好。
I'll start with Slide 25.
我將從幻燈片 25 開始。
So 2019 was a very strong year for Pharmaceuticals, with 12% growth.
因此,2019 年對製藥業來說是非常強勁的一年,增長了 12%。
Our key growth drivers, Cosentyx and Entresto, grew 28% and 71% respectively.
我們的主要增長動力 Cosentyx 和 Entresto 分別增長了 28% 和 71%。
We also laid the foundation for our next phase of growth.
我們也為下一階段的增長奠定了基礎。
We're off to a great start with Beovu in the U.S. We're accelerating Mayzent and Xiidra, and we've add inclisiran to the portfolio.
我們在美國的 Beovu 有了一個良好的開端。我們正在加速 Mayzent 和 Xiidra,我們已將 inclisiran 添加到產品組合中。
Next slide.
下一張幻燈片。
Cosentyx had a fantastic year with strong growth through multiple competitor entries.
Cosentyx 度過了美好的一年,通過多個競爭對手的進入實現了強勁增長。
The underlying growth is very strong and the demand is strong.
潛在增長非常強勁,需求強勁。
Actually in the U.S., we even accelerated versus prior year, and we're outperforming the market both in dermatology and rheumatology.
實際上,在美國,我們甚至比前一年加速了,我們在皮膚病學和風濕病學方面的表現都優於市場。
With the strong first-line access we secured and continued news flow; for example, our MAXIMIZE and PREVENT trials, we really expect to maintain this momentum in 2020 and are confident for the future.
憑藉強大的一線訪問權限,我們確保並持續不斷的新聞流;例如,我們的 MAXIMIZE 和 PREVENT 試驗,我們真的希望在 2020 年保持這種勢頭,並對未來充滿信心。
In fact, we're increasing our guidance to beyond $5 billion.
事實上,我們正在將我們的指導增加到超過 50 億美元。
Next slide.
下一張幻燈片。
Entresto also saw impressive growth in 2019 at an all-time high, and I'm very pleased with the strong execution in the market.
Entresto 在 2019 年也看到了令人印象深刻的增長,創下歷史新高,我對市場的強勁執行感到非常滿意。
We feel that we have all of the components to sustain this momentum.
我們認為我們擁有維持這一勢頭的所有要素。
We've got a strong evidence base for in-hospital initiation, but also ambulatory treatment.
我們為住院治療和門診治療提供了強有力的證據基礎。
We see increasing guideline support for Entresto as a first-choice treatment.
我們看到越來越多的指南支持將 Entresto 作為首選治療。
And of course in 2020, we have very nice expansion opportunities in new markets, particularly in China and Japan.
當然,在 2020 年,我們在新市場有很好的擴張機會,尤其是在中國和日本。
Slide 27 -- or 28, sorry, excuse me.
幻燈片 27 或 28,對不起,對不起。
In Beovu, we're very pleased with the U.S. launch, particularly the excellent customer feedback.
在 Beovu,我們對美國的推出感到非常滿意,尤其是出色的客戶反饋。
We've seen very strong uptake from retina specialists.
我們已經看到視網膜專家非常強烈地接受。
And with the permanent J-code, there's strong confidence for reimbursement.
有了永久J碼,報銷信心大增。
The feedback has been outstanding.
反饋非常出色。
What we hear the most is that physicians are incredibly impressed with Beovu's drying properties and with the efficacy.
我們聽到最多的是,醫生對 Beovu 的干燥特性和功效印象深刻。
We're also looking forward to an EC approval later this quarter and Q2 approval in Japan.
我們也期待本季度晚些時候獲得歐盟委員會的批准以及日本的第二季度批准。
And we expect Beovu to become a major player across the globe.
我們預計 Beovu 將成為全球的主要參與者。
Slide 29.
幻燈片 29。
Ofatumumab, we are very, very excited about this opportunity, and we're getting focused to bring this product as quickly as possible to patients.
Ofatumumab,我們對這個機會非常非常興奮,我們正專注於盡快將該產品帶給患者。
We filed both in the U.S. and the EU.
我們在美國和歐盟都提交了申請。
And I just want to spend a moment on this, because there's a real shift happening in the marketplace about how physicians treat MS, and this leads us to believe that we have a truly unique product profile with ofatumumab.
我只想花一點時間在這方面,因為市場上正在發生關於醫生如何治療 MS 的真正轉變,這使我們相信我們擁有真正獨特的 ofatumumab 產品概況。
What physicians tell us is that they increasingly believe that it is best to use the most efficacious therapy upfront.
醫生告訴我們的是,他們越來越相信最好預先使用最有效的治療方法。
And if you think about ofatumumab, we offer unsurpassed efficacy of B-cell depletion.
如果您想到 ofatumumab,我們會提供無與倫比的 B 細胞耗竭功效。
If you look at the chart on the left, which we presented at our R&D day, you'll see that the confirmed disability worsening data is very impressive.
如果您查看我們在研發日展示的左側圖表,您會發現確認的殘疾惡化數據非常令人印象深刻。
If you combine that with a very favorable safety profile, an easy mode of administration, we'll have an auto-injector at launch, we're really proposing a winning first-line value proposition.
如果您將其與非常有利的安全配置、簡單的管理模式相結合,我們將在發佈時擁有自動注射器,我們確實提出了一個成功的一線價值主張。
So our objective this year is to really focus on making sure that we can provide broad access to as many neurologists as possible and, of course, to as many patients as possible.
因此,我們今年的目標是真正專注於確保我們能夠為盡可能多的神經科醫生提供廣泛的訪問,當然也包括盡可能多的患者。
Slide 30.
幻燈片 30。
We're also very excited about our opportunity with inclisiran because the profile, including this administration twice a year, really lends itself to significantly impacting cardiovascular mortality in a very broad patient population.
我們也對我們與 inclisiran 的機會感到非常興奮,因為該概況,包括每年兩次的給藥,確實有助於顯著影響非常廣泛的患者群體的心血管死亡率。
We've begun the integration, which we will complete by March, and we've also filed in both the U.S. and in the EU.
我們已經開始整合,我們將在 3 月份完成,我們還在美國和歐盟提交了申請。
We're ongoing with our bridging studies in Japan and China.
我們正在日本和中國進行橋接研究。
So the key focus for this year is to provide broad and affordable access and start engaging with payers in multiple different countries.
因此,今年的重點是提供廣泛且負擔得起的接入,並開始與多個不同國家的付款人接觸。
So all in all, if we move to the last slide, we have a very clear strategy for 2020.
所以總而言之,如果我們轉到最後一張幻燈片,我們有一個非常明確的 2020 年戰略。
We're going to continue the momentum with Cosentyx and Entresto, with a strong focus on preparing our launches, so scaling Beovu, launching ofatumumab and inclisiran.
我們將繼續與 Cosentyx 和 Entresto 合作,重點關注我們的發布準備工作,從而擴大 Beovu,推出 ofatumumab 和 inclisiran。
And the biggest shift that you'll see is that we firmly have our eyes on the future.
您將看到的最大轉變是我們堅定地著眼於未來。
We have a number of fantastic assets and they're only a few years away.
我們擁有許多出色的資產,而且距離它們只有幾年的時間。
We're investing earlier in our launches, and we're making sure that we're prepared well ahead of time.
我們更早地投資於我們的發布,並確保我們提前做好準備。
I'm really confident in the teams that we have across the globe, and I just want to thank them for their outstanding work in 2019.
我對我們在全球擁有的團隊非常有信心,我只想感謝他們在 2019 年的出色工作。
I'd like to pass on to Susanne.
我想轉給蘇珊娜。
Susanne Schaffert - President of Novartis Oncology
Susanne Schaffert - President of Novartis Oncology
Thank you, Marie-France, and good morning, good afternoon, everybody.
謝謝你,Marie-France,大家早上好,下午好。
So let's move to Slide 33.
那麼讓我們轉到幻燈片 33。
Also for Oncology, we had a very good year.
同樣對於腫瘤學,我們度過了非常好的一年。
We reached sales of $14.8 (sic) [14.4] billion and delivered growth of 10%.
我們的銷售額達到了 14.8 美元(原文如此)[14.4] 億美元,實現了 10% 的增長。
So I'm really proud of what the oncology team has achieved.
因此,我為腫瘤學團隊所取得的成就感到非常自豪。
The growth was mainly driven by the strong uptake of our recently launched products, including Lutathera, Kymriah, Kisqali and Piqray, but we also saw continued very strong momentum from our growth drivers, Jakavi, Promacta/Revolade and Mekinist/Tafinlar (sic) [Mekinist + Tafinlar].
增長主要是由我們最近推出的產品的強勁吸收推動的,包括 Lutathera、Kymriah、Kisqali 和 Piqray,但我們也看到我們的增長驅動力持續非常強勁的勢頭,Jakavi、Promacta/Revolade 和 Mekinist/Tafinlar (sic) [ Mekinist + Tafinlar]。
We aggressively shifted investments to our growth drivers, to our launches and prelaunches to really invest early and also approved an investment case for China.
我們積極將投資轉移到我們的增長動力、我們的發布和預發布以真正儘早投資,並批准了中國的投資案例。
And the growth really could more than compensate for generic impact we saw in 2019, mainly from Afinitor and Sandostatin LAR in Europe and Exjade/Jadenu in the U.S.
這種增長確實可以彌補我們在 2019 年看到的一般影響,主要來自歐洲的 Afinitor 和 Sandostatin LAR 以及美國的 Exjade / Jadenu。
So moving to Slide 34.
所以轉到幻燈片 34。
One of the key growth areas for us was our breast cancer portfolio.
我們的主要增長領域之一是我們的乳腺癌產品組合。
We have launched Piqray in June 2019.
我們於 2019 年 6 月推出了 Piqray。
This is a first-in-class PIK3CA inhibitor indicated for 40% of HR-positive, HER2-negative metastatic breast cancer patients with a PIK3CA mutation.
這是一種一流的 PIK3CA 抑製劑,適用於 40% 的具有 PIK3CA 突變的 HR 陽性、HER2 陰性轉移性乳腺癌患者。
And these patients usually have a very poor prognosis.
而且這些患者的預後通常很差。
So very high medical need.
所以非常高的醫療需求。
The product had a very strong start, delivering $118 million of sales in 2019, and we're very pleased that testing rate was up to 25% at year-end, starting at 5% probably in the beginning of the year.
該產品有一個非常強勁的開端,2019 年實現了 1.18 億美元的銷售額,我們很高興年底的測試率高達 25%,可能從年初的 5% 開始。
We have launched a product with a Qiagen test and now also have approval for the Foundation Medicine's tissue test and expect the plasma test of Foundation Medicine to be approved by Q2 2020.
我們已經推出了一款帶有 Qiagen 測試的產品,現在還獲得了 Foundation Medicine 組織測試的批准,預計 Foundation Medicine 的血漿測試將在 2020 年第二季度獲得批准。
In addition, we have launched a very broad development program in 5 new indications called the EPIK program, with the potential to serve additional 100,000 patients with Piqray.
此外,我們還在 5 個新適應症中啟動了一項非常廣泛的開發計劃,稱為 EPIK 計劃,有可能為額外的 100,000 名 Piqray 患者提供服務。
Also, Kisqali had a very great year, reaching $480 million of sales.
此外,Kisqali 也度過了非常棒的一年,銷售額達到了 4.8 億美元。
Just to remind you, Kisqali is the only CDK 4/6 that consistently demonstrated superior overall survival in 2 pivotal Phase III trials.
提醒您一下,Kisqali 是唯一在 2 項關鍵 III 期試驗中始終表現出卓越總體存活率的 CDK 4/6。
We saw clear early signs of accelerated growth both in the U.S. and very, very strong continued growth ex U.S. So very pleased with the performance.
我們看到了美國加速增長的明顯早期跡象,以及美國以外非常非常強勁的持續增長。因此對業績感到非常滿意。
We are also rapidly enrolling in our NATALEE trial.
我們也正在迅速報名參加我們的 NATALEE 試驗。
This is a trial in high and intermediate adjuvant breast cancer.
這是一項針對高、中級輔助乳腺癌的試驗。
NATALEE has a different design than the other ongoing trials in adjuvant setting with 3 years' treatment and could potentially get registration as early as 2022 based on a positive preplanned interim analysis.
NATALEE 的設計與其他正在進行的為期 3 年的輔助環境試驗不同,根據預先計劃的積極中期分析,可能最早在 2022 年獲得註冊。
So moving to Slide 35.
所以轉到幻燈片 35。
The second launch we had in 2019 was Adakveo, the only approved product for the reduction of frequency of vaso-occlusive crisis, or VOCs, in sickle cell disease.
我們在 2019 年推出的第二個產品是 Adakveo,這是唯一獲批的用於降低鐮狀細胞病血管閉塞性危象 (VOC) 頻率的產品。
In the U.S., there are more than 54,000 patients suffering from sickle cell disease and having more than 1 VOC per year.
在美國,每年有超過 54,000 名患者患有鐮狀細胞病,且 VOC 含量超過 1。
And therefore there is a huge medical need.
因此存在巨大的醫療需求。
We have made the commercial product available 2 days after approval, and we are now actively engaging with payers, working through reimbursement.
我們在批准後 2 天就提供了商業產品,我們現在正在積極與付款人接觸,通過報銷工作。
We saw already initial orders from community centers.
我們已經看到來自社區中心的初步訂單。
We have applied a permanent J code that we expect in July 2020.
我們已經應用了我們預計在 2020 年 7 月發布的永久 J 代碼。
And usually it takes about 18 months to achieve reimbursement across the country, but we are very pleased that already 6 states published their guidelines for Adakveo.
通常在全國范圍內實現報銷大約需要 18 個月,但我們很高興已經有 6 個州發布了他們的 Adakveo 指南。
So moving to the next slide, giving an outlook on 2020, we will continue to maximize our growth drivers.
因此,轉到下一張幻燈片,展望 2020 年,我們將繼續最大化我們的增長動力。
We expect continued growth from Kisqali.
我們預計 Kisqali 將繼續增長。
We plan to tap into the potential of earlier lines with Lutathera, and we expect continued growth in Revolade/Promacta from ITP and also first-line SAA in the U.S. and Japan.
我們計劃利用 Lutathera 早期生產線的潛力,我們預計 ITP 的 Revolade/Promacta 以及美國和日本的一線 SAA 將繼續增長。
We are committed to deliver on our launches.
我們致力於交付我們的發布。
We will further expand Piqray in the U.S. and prepare for the launch in Europe.
我們將進一步在美國擴展 Piqray,並為在歐洲的推出做準備。
And we hope to continue strong on Adakveo, expanding to larger accounts in the U.S. and drive further capacity increase for Kymriah to meet the strong demand in pediatric ALL and DLBCL.
我們希望繼續在 Adakveo 上保持強勢,擴展到美國的更大客戶,並推動 Kymriah 的產能進一步增加,以滿足兒科 ALL 和 DLBCL 的強勁需求。
Last but not least, we will prepare for our next big bet, capmatinib, with the potential to be the first to market c-Met inhibitor.
最後但同樣重要的是,我們將為我們的下一個大賭注 capmatinib 做準備,它有可能成為第一個上市的 c-Met 抑製劑。
Expecting the data readout of our PD-L1 spartalizumab in combination with Mekinist and Tafinlar, preparing our commercial organization for the readout of lutetium-PSMA later this year and also focus medical education on canakinumab to establish the importance of inhibition of tumor-promoting inflammation.
期待我們的 PD-L1 spartalizumab 與 Mekinist 和 Tafinlar 結合的數據讀出,為我們的商業組織準備今年晚些時候讀出镥-PSMA,並將醫學教育重點放在 canakinumab 上,以確定抑制促腫瘤炎症的重要性。
So with that, I will hand over to Harry.
因此,我將移交給哈利。
Harry Kirsch - CFO
Harry Kirsch - CFO
Yes.
是的。
Thank you, Susanne.
謝謝你,蘇珊。
Good morning, good afternoon, everybody.
大家早上好,下午好。
My comments refer to the results of our continuing operations.
我的評論是指我們持續經營的結果。
And growth rates are in constant currencies, unless I would note otherwise.
除非我另有說明,否則增長率是以固定貨幣計算的。
So moving to the next slide.
所以轉到下一張幻燈片。
As Vas said, 2019 has been an exceptional year overall, for the results of the company and the financial results.
正如 Vas 所說,就公司的業績和財務業績而言,2019 年總體上是不平凡的一年。
On Slide 38, we compare our actual results with our latest guidance.
在幻燈片 38 上,我們將我們的實際結果與我們最新的指導進行了比較。
As you know, we revised guidance upward throughout the year and delivered as expected.
如您所知,我們全年向上修訂指導並按預期交付。
Full year sales growth was 9% and core operating income growth 17%.
全年銷售額增長9%,核心營業收入增長17%。
Slide 39 shows a summary of our quarter 4 and full year performance.
幻燈片 39 顯示了我們第四季度和全年業績的摘要。
Basically, quarter 4 followed the same pattern as each quarter of 2019 and the full year.
基本上,第 4 季度遵循與 2019 年每個季度和全年相同的模式。
Focusing on the full year, the sales increased high single digit, driving accretive double-digit core operating income and core EPS growth of 17% each.
著眼於全年,銷售額實現高個位數增長,推動核心營業收入和核心每股收益均實現兩位數增長17%。
This resulted also in a strong free cash flow of $12.9 billion, up 15% in U.S. dollars versus prior year.
這也帶來了 129 億美元的強勁自由現金流,以美元計算比上年增長 15%。
The net income decline you see here is entirely due to the $5.7 billion OTC joint venture onetime net gain that we recorded in 2018 when we divested our stake to GSK.
您在此處看到的淨收入下降完全是由於我們在 2018 年將股份出售給葛蘭素史克時記錄的 57 億美元的 OTC 合資企業一次性淨收益。
Now you will recall that one of our key financial priorities is to increase free cash flow, and we have delivered another strong result in 2019.
現在您會記得,我們的主要財務優先事項之一是增加自由現金流,我們在 2019 年又取得了強勁的業績。
On Slide 40 the free cash flow of 2019 is compared with 2018.
在幻燈片 40 上,將 2019 年的自由現金流與 2018 年進行了比較。
And our free cash flow increase was mainly driven by operating income adjusted for noncash items.
我們的自由現金流增加主要是由非現金項目調整後的營業收入推動的。
As you can see, we had a couple of large onetime items, which we of course also reported.
如您所見,我們有幾個大型一次性項目,當然我們也報告了這些項目。
And they are offsetting each other, some divestment gains, but in also 2018 when we still had the OTC joint venture and another milestone from the prior portfolio deals.
它們相互抵消,一些撤資收益,但在 2018 年,我們仍然擁有 OTC 合資企業和之前投資組合交易的另一個里程碑。
Of course we will continue to place a strong focus on cash flow management also going forward.
當然,我們也將繼續將重點放在現金流管理上。
Next slide.
下一張幻燈片。
As you can see on Slide 41, we are proposing the 23rd consecutive dividend increase to CHF 2.95 per share.
正如您在幻燈片 41 中看到的,我們提議連續第 23 次將股息提高至每股 2.95 瑞士法郎。
This is an increase of 3.5%, and the dividend yield remains above 3%.
這增加了 3.5%,股息收益率保持在 3% 以上。
It's, of course, also fully in line with our dividend policy of increasing our dividend every year in Swiss francs.
當然,這也完全符合我們每年以瑞士法郎增加股息的股息政策。
On Slide 42, you see our strong core margin improvement in quarter 4 and the full year.
在幻燈片 42 上,您會看到我們在第四季度和全年的強勁核心利潤率改善。
Given the excellent sales execution and productivity focus, core margin grew in each quarter and the full year for both divisions.
鑑於出色的銷售執行和生產力重點,兩個部門的每個季度和全年的核心利潤率都在增長。
Full year continuing operations margin improved by 1.9% points.
全年持續經營利潤率提高 1.9 個百分點。
And in Innovative Medicines, sales grew 11%, driving 18% core operating income growth and enabling the margin to improve to 33.5%, up plus 1.8% versus prior year.
在創新藥物方面,銷售額增長 11%,推動核心營業收入增長 18%,並使利潤率提高至 33.5%,較上年增長 1.8%。
At the same time, we have been increasing investments to support our many launches and prelaunches.
與此同時,我們一直在增加投資以支持我們的許多發布和預發布。
With this result, we are clearly on track to deliver our medium-term core margin guidance of mid- to high 30s for Innovative Medicines.
有了這個結果,我們顯然有望為創新藥物提供 30 多歲的中期核心利潤率指導。
Sandoz had a solid year, returning for growth with sales growing 2%.
山德士今年表現穩健,銷售額增長 2%,恢復增長。
Core operating income grew much stronger than sales driven by the sales growth, but also continued gross margin improvements and the ongoing business transformation.
在銷售增長的推動下,核心營業收入的增長遠強於銷售額,而且毛利率的持續改善和持續的業務轉型也是如此。
The Sandoz core margin for 2019 was 21.5%, up 1.5% versus prior year.
山德士 2019 年的核心利潤率為 21.5%,比上年增長 1.5%。
Now moving to the 2020 full year guidance on Slide 43.
現在轉到幻燈片 43 的 2020 年全年指導。
In short, we anticipate the strong business momentum of 2019 to continue in 2020.
簡而言之,我們預計 2019 年的強勁業務勢頭將在 2020 年持續。
For the focused medicines company, we expect sales growth in the range of mid- to high single digits.
對於專注的藥品公司,我們預計銷售額將在中高個位數範圍內增長。
By division, Innovative Medicines sales are expected to grow mid- to high single digits.
按部門劃分,創新藥物銷售額預計將增長中高個位數。
And Sandoz sales are expected to grow low single digit.
山德士的銷售額預計將以低個位數增長。
Once again, we expect accretive growth and margin improvement in 2020.
再次,我們預計 2020 年將實現增長和利潤率改善。
Core operating income is expected to grow ahead of sales in the high single to low double-digit range.
預計核心營業收入將在高個位數至低兩位數範圍內的銷售額之前增長。
Our guidance includes the forecast assumption.
我們的指導包括預測假設。
As you can see at the bottom of this slide, that no Gilenya or Sandostatin LAR generics would enter in 2020 in the U.S. Further, the guidance excludes the Sandoz U.S. oral solids and derm portfolio, which we're in the process of divesting, in both years, in 2020 and 2019.
正如您在這張幻燈片底部看到的那樣,Gilenya 或 Sandostatin LAR 仿製藥將在 2020 年進入美國市場此外,該指南不包括 Sandoz 美國口服固體和真皮產品組合,我們正在剝離這些產品,在這兩年,2020 年和 2019 年。
We expect to close the sale to Aurobindo in quarter 1.
我們預計將在第一季度完成對 Aurobindo 的銷售。
Let me add a word on quarterly core op income, core operating income dynamics in 2020.
讓我補充一下季度核心運營收入,2020 年核心運營收入動態。
We do expect that quarter 1 will be at the upper end of the full year guidance.
我們確實預計第一季度將處於全年指導的上限。
This is due mainly to 2 drivers.
這主要是由於2個司機。
First, the generics we were already also discussing, the impacts are expected to be lower in quarter 1 as we model a ramp-up throughout the year.
首先,我們已經討論過仿製藥,預計第一季度的影響會降低,因為我們模擬了全年的增長。
So the overall generic burn will be a bit higher than 2019, but ramping up as we model it.
因此,總體通用消耗將比 2019 年略高,但隨著我們的建模而增加。
And second, in quarter 1 we are not yet lapping the Zolgensma launch -- you may recall last year we got [an AD] approval -- and also not the midyear Xiidra acquisition of last year.
其次,在第一季度,我們還沒有完成 Zolgensma 的發布——你可能還記得去年我們獲得了 [an AD] 批准——也不是去年年中 Xiidra 的收購。
On Slide 44, just to -- I would like to add some perspective on other key elements of our expected bottom line performance beyond core operating income.
在幻燈片 44 上,我想就除核心營業收入之外的預期底線業績的其他關鍵要素添加一些觀點。
We expect core net financial expenses to increase by around $0.2 billion, reflecting the financing cost of our acquisition of The Medicines Company.
我們預計核心淨財務費用將增加約 2 億美元,這反映了我們收購 The Medicines Company 的融資成本。
Core taxes are expected to be broadly in line with 2019, which is in the range of 16%.
預計核心稅將與 2019 年大致持平,在 16% 的範圍內。
And with that, I hand it back to Vas.
有了這個,我把它交還給 Vas。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Harry.
謝謝你,哈利。
So just to close, if we move to Slide 46.
因此,如果我們移至幻燈片 46,請關閉。
Just to reiterate again, a strong performance, really an exceptional performance in 2019.
再次重申,強勁的表現,2019 年的出色表現。
A big thank you to the entire Novartis organization for a truly outstanding year, delivering on our long-term strategy and our operational performance.
非常感謝整個 Novartis 組織,他們在這一年中表現出色,實現了我們的長期戰略和運營績效。
In closing with Slide 47, again just to highlight, the portfolio and the medicines we create are the strength of this company.
在幻燈片 47 結束時,再次強調,我們創造的產品組合和藥物是這家公司的實力。
We believe we have the right profile to deliver growth for the long term.
我們相信我們有合適的形象來實現長期增長。
And we look forward to consistently demonstrating that in 2020.
我們期待在 2020 年始終如一地證明這一點。
So with that, we can open the lines for questions and answers.
因此,我們可以打開問題和答案的線路。
Thank you.
謝謝你。
Operator
Operator
(Operator Instructions) Your first question comes from the line of Steve Scala from Cowen.
(操作員說明)您的第一個問題來自 Cowen 的 Steve Scala。
Stephen Michael Scala - MD & Senior Research Analyst
Stephen Michael Scala - MD & Senior Research Analyst
I have a couple of questions.
我有一些問題。
First on Zolgensma, Vas, you mentioned that conversations are going well in the EU and Japan, but I don't think you stated the tone around the U.S. discussions.
首先談到 Zolgensma,Vas,你提到歐盟和日本的對話進展順利,但我認為你沒有表達圍繞美國討論的基調。
I think back to John Tsai's comments at the R&D meeting last month, which also did not offer optimism.
我回想起上個月蔡崇信在研發會議上的評論,這也並不樂觀。
It seems that things are tough with FDA on the IT study.
似乎 FDA 在 IT 研究方面的情況很艱難。
And I'm just wondering if you would say that, that's not the case.
我只是想知道你是否會這麼說,事實並非如此。
And then secondly on Xiidra, Novartis's rationale for the acquisition was that its marketing force would boost sales, but growth has been slow.
其次,關於 Xiidra,諾華收購的理由是其營銷力量將促進銷售,但增長緩慢。
And it didn't get mentioned in the prepared remarks, other than Harry mentioning that you acquired the asset.
在準備好的評論中沒有提到它,除了哈利提到你獲得了資產。
When should we expect this inflection in Xiidra?
我們應該在什麼時候期待 Xiidra 的這種變化?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Steve.
謝謝你,史蒂夫。
So I'll take Zolgensma and I'll hand it to Marie-France for Xiidra.
所以我會帶走 Zolgensma 並將它交給 Marie-France 用於 Xiidra。
So I would not agree with your characterization.
所以我不同意你的描述。
I think we have had good discussions with the FDA.
我認為我們與 FDA 進行了很好的討論。
We're clear on the information we need to provide, both from a preclinical standpoint as well as the clinical data, which is the most important element of the story in terms of the -- how the patients are doing from the STRONG study.
我們很清楚我們需要提供的信息,無論是從臨床前的角度還是從臨床數據的角度來看,就患者在 STRONG 研究中的表現而言,這是故事中最重要的元素。
We plan to provide that data package to the FDA in the coming weeks.
我們計劃在未來幾週內將該數據包提供給 FDA。
Then assuming we adequately have answered their questions, I would expect -- or at least hope that we would get off of clinical hold.
然後假設我們已經充分回答了他們的問題,我希望——或者至少希望我們能夠擺脫臨床擱置。
We would then move forward with a pre-BLA proposal for the filing of the STRONG data for an IT approval, and we continue to guide to a filing of AVXS-101 IT in 2020.
然後,我們將推進 BLA 前提案,以提交 STRONG 數據以供 IT 批准,我們將繼續指導 2020 年提交 AVXS-101 IT。
Now with respect to Xiidra, Marie-France?
現在關於 Xiidra,Marie-France?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
So we've always said that we had to rebuild this brand.
所以我們一直說我們必須重建這個品牌。
So we went through a complete restructuring, which we've now completed.
因此,我們進行了徹底的重組,現在我們已經完成了。
The product has great potential.
該產品潛力巨大。
As we know, the marketplace is huge, 34 million patients in the U.S. and only 1.6 million of those are currently on a prescription product for their dry eye disease.
眾所周知,市場是巨大的,美國有 3400 萬患者,其中只有 160 萬目前正在服用治療乾眼症的處方藥。
We also know that the product has a unique product profile.
我們還知道該產品具有獨特的產品配置文件。
It's the only one to treat the signs and symptoms.
這是唯一可以治療症狀和體徵的方法。
So we are through this restructuring.
所以我們是通過這次重組。
We returned to DTC in Q4.
我們在第四季度回到了 DTC。
We're going to continue to invest in Q1 and return to growth certainly by the second half of the year with greater share of voice and DTC strength.
我們將繼續在第一季度投資,並在下半年肯定會恢復增長,語音和 DTC 實力的份額更大。
Operator
Operator
Your next question comes from the line of Graham Parry from Bank of America.
您的下一個問題來自美國銀行的 Graham Parry。
Graham Glyn Charles Parry - MD and Head of Healthcare Equity Research
Graham Glyn Charles Parry - MD and Head of Healthcare Equity Research
Firstly on Gilenya and the litigation, we see overnight that you sued on the newly issued 179 patent, which had some additional language on infection prevention.
首先是關於 Gilenya 和訴訟,我們在一夜之間看到你起訴了新發布的 179 專利,該專利有一些關於感染預防的額外語言。
I was just wondering, should we view this as any signal that you have any concern that you might not win the IPR appeal or any lack of confidence in your 405 patent litigation?
我只是想知道,我們是否應該將此視為任何信號,表明您擔心您可能無法贏得知識產權上訴或對您的 405 專利訴訟缺乏信心?
And how does seemingly evergreening the patents fit with Novartis's social trust agenda?
看似常青的專利如何與諾華的社會信任議程相契合?
Do you think there's some reputational risk here, that you seem to be trying to extend the patent life unfairly here?
您是否認為這裡存在一些聲譽風險,您似乎試圖在這裡不公平地延長專利期限?
Secondly, on Zolgensma, the timing that you're giving for the intrathecal filing of the 2020 is obviously somewhat vague.
其次,在 Zolgensma 上,您為 2020 年的鞘內歸檔提供的時間顯然有些模糊。
I was just wondering if you could try to tighten that into first half, second half.
我只是想知道您是否可以嘗試將其收緊到上半場,下半場。
And I was wondering, just on your comment earlier about, I think you said 100 patients per quarter through 2020.
我想知道,就你之前的評論,我想你說到 2020 年每季度有 100 名患者。
Why no inflection there without intrathecal?
為什麼沒有鞘內沒有拐點?
Are you just fully penetrated into incident patients and there's no more prevalent patients under 2 left?
您是否剛剛完全滲透到事件患者中,並且沒有 2 歲以下的流行患者?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes.
是的。
Thanks, Graham.
謝謝,格雷厄姆。
So there are 2 separate things going on right now with respect to Gilenya.
因此,關於 Gilenya,目前有兩件不同的事情正在發生。
We have the 405 patent, which was held up in the IPR, and is currently under an IPR appeal in the Federal Circuit.
我們擁有 405 專利,該專利在 IPR 中被擱置,目前正在聯邦巡迴法院進行 IPR 上訴。
Also, that 405 patent is being appealed as well in district court.
此外,該 405 專利也在地方法院被上訴。
And both of those trials are either ongoing or soon to start, and we expect decisions in both trials over the course of 2020.
這兩項試驗要么正在進行,要么即將開始,我們預計這兩項試驗將在 2020 年作出決定。
And we'll, of course, keep you all up to date.
當然,我們會為您提供最新信息。
And we continue to believe that the strength of that patent -- in the strength of that patent [and] continue to work to defend that fully.
我們繼續相信該專利的力量——憑藉該專利的力量[並]繼續努力充分捍衛這一點。
Separate from that, yesterday we received a U.S. patent related to the treatment of RMS by determining varicella-zoster status and vaccinating in appropriate cases.
除此之外,昨天我們收到了一項與治療 RMS 相關的美國專利,該專利通過確定水痘帶狀皰疹的狀態並在適當的情況下接種疫苗。
We actually had filed this patent close to 8 to 9 years ago.
實際上,我們在 8 到 9 年前就已經提交了這項專利。
It's just that the patent was issued only yesterday.
只是專利是昨天才發布的。
And we immediately then filed infringement lawsuits in the U.S. District Court against all generic companies that are still currently involved in the dosing regimen patent litigation.
然後我們立即在美國地方法院對目前仍參與給藥方案專利訴訟的所有仿製藥公司提起侵權訴訟。
So not necessarily all companies, but those companies that have not settled with us on the dosing regimen patent litigation.
因此,不一定是所有公司,而是那些尚未與我們就給藥方案專利訴訟達成和解的公司。
Again, to your comment on evergreening, we don't view this as evergreening.
同樣,對於您對常青樹的評論,我們不認為這是常青樹。
We view this as legitimately defending patents that we filed long ago based on insights on how the mechanism of Gilenya operates.
基於對 Gilenya 機制如何運作的見解,我們認為這是對我們很久以前提交的專利的合法辯護。
In this case, with respect to zoster virus, in the previous case with respect to dose as the dose differed from transplant medications for the use of the drug in the transplant setting.
在這種情況下,就帶狀皰疹病毒而言,在先前的情況下,就劑量而言,因為在移植環境中使用藥物的劑量與移植藥物不同。
So that's the situation.
所以情況就是這樣。
We continue to pursue these various lines, and we'll see ultimately how the year unfolds and keep all of you up-to-date as these various lines of discussion continue.
我們將繼續追求這些不同的路線,我們將最終看到這一年如何展開,並隨著這些不同的討論路線的繼續,讓你們所有人保持最新狀態。
Now with respect to Zolgensma IT, difficult for me to tighten this any further, I think, until we submit the pre-BLA meeting request.
現在關於 Zolgensma IT,我認為,在我們提交 BLA 前會議請求之前,我很難進一步加強這一點。
I think it would be premature to do so.
我認為這樣做還為時過早。
If everything were to go exactly as we wanted, we could file as early as mid of this year.
如果一切都如我們所願,我們最早可以在今年年中提交申請。
If the FDA asked us to provide additional information from the high dose of the STRONG study, we would probably be towards more at the end of this year.
如果 FDA 要求我們提供來自高劑量 STRONG 研究的更多信息,我們可能會在今年年底提供更多信息。
So it really depends on us getting that feedback from the FDA.
所以這真的取決於我們從 FDA 那裡得到反饋。
And as soon as we have that feedback, we'll of course provide it back to you.
一旦我們收到反饋,我們當然會將其提供給您。
Now with respect to the dynamics we see in the U.S., you saw a strong Q3, a strong Q4.
現在就我們在美國看到的動態而言,您看到了強勁的第三季度和第四季度。
Right now, what we see is continued share gains in the under 6-month segment.
目前,我們看到的是 6 個月以下的市場份額持續增長。
But we also, of course, have the 6 to 18 months -- 6- to 24-months-old starting to age out of the segment.
但是,當然,我們也有 6 到 18 個月——6 到 24 個月大的嬰兒開始老化。
So I think right now, we're guiding to an offset of our gains in under 6 months offsetting the aging out of the 6 to 24 months.
所以我認為現在,我們正在引導我們在 6 個月內抵消我們的收益,以抵消 6 到 24 個月的老化。
The next inflection points will first come actually from the European approval.
下一個拐點實際上將首先來自歐洲的批准。
It turns out that for the SMA market, the ex U.S. market is larger than the U.S. market.
事實證明,對於 SMA 市場,除美國市場大於美國市場。
So on European approval, as I said, we expect CHMP opinion in first quarter; Japanese approval, which we also expect in the first half; and then a range of other country approvals.
因此,正如我所說,關於歐洲的批准,我們預計第一季度 CHMP 的意見;日本的批准,我們也在上半年獲得批准;然後是一系列其他國家的批准。
There's sizable market opportunities in the Middle East as well as in Latin America.
中東和拉丁美洲都有相當大的市場機會。
Those filings are also in and we would expect all of those to be inflection points for the IV under 2 years as Zolgensma.
這些文件也在其中,我們預計所有這些都將成為 Zolgensma 2 年內 IV 的轉折點。
And then separate from that, the IT would be a further inflection point once approved.
此外,一旦獲得批准,IT 將成為進一步的轉折點。
Operator
Operator
Your next question comes from the line of Andrew Baum from Citi.
您的下一個問題來自花旗銀行的 Andrew Baum。
Andrew Simon Baum - Global Head of Healthcare Research and MD
Andrew Simon Baum - Global Head of Healthcare Research and MD
A couple of questions, please.
有幾個問題,請。
You've indicated that you are going to file Entresto for preserved ejection fraction heart failure sometime in Q1 with respect to [reparalac].
您已表示您將在第一季度的某個時間就 [reparalac] 向 Entresto 提交保留射血分數心力衰竭。
Could you just give us some details on what population you're filing as they're modestly reduced?
你能不能給我們一些關於你申請的人口數量的細節,因為他們適度減少了?
Is it women?
是女人嗎?
Is it both?
兩者都有嗎?
Secondly, how much weight do you really put on the 179 patent?
其次,你對 179 專利到底有多大的權重?
Surely a carve-out and a skinny label would seem to circumvent, given the widespread prevalence of varicella vaccination in the U.S. market.
鑑於水痘疫苗在美國市場的廣泛流行,分拆和緊縮標籤似乎可以規避。
And then finally, on lutetium-PSMA, is the therapy trial filable in addition to your Phase III trial, broadening the initial approvals for this product in refractory prostate cancer?
最後,關於 lutetium-PSMA,除了您的 III 期試驗外,治療試驗是否可行,從而擴大了該產品在難治性前列腺癌中的初始批准範圍?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Okay.
好的。
So first on the indication for Entresto in preserved ejection fraction heart failure, John?
那麼首先是關於 Entresto 在保留射血分數心力衰竭中的適應症,約翰?
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes, just -- thanks for the question, Andrew.
是的,只是 - 謝謝你的問題,安德魯。
Just in terms of a quick reminder for folks, on PARAGON study, the results came out in the third quarter of the year, where we saw a very narrow miss with a p-value of 0.059 in terms of patients with preserved ejection fraction.
只是為了快速提醒人們,在 PARAGON 研究中,結果在今年第三季度出爐,在保留射血分數的患者方面,我們看到了一個非常小的失誤,p 值為 0.059。
We've had good discussions with the U.S. FDA, and the approach that we would take is a broad indication, given the benefits that we've seen across the population.
我們與美國 FDA 進行了良好的討論,鑑於我們在人群中看到的好處,我們將採取的方法是一個廣泛的跡象。
And we'll have continued dialogue with the regulatory agency on the approach moving forward.
我們將繼續與監管機構就前進的方法進行對話。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And so then on the 179 patent, we -- overall our view is that we have -- we're confident in the strength of both the dosing regimen patent and the Zoster patent.
因此,在 179 號專利上,我們 - 總體而言,我們認為我們擁有 - 我們對給藥方案專利和 Zoster 專利的實力充滿信心。
We think, given that the Zoster patent relates to the safety of the product, we feel like it is a strong patent, and we'll continue to vigorously defend our IP rights, particularly against those companies that have not yet settled overall with respect to Gilenya.
我們認為,鑑於 Zoster 專利與產品的安全性相關,我們認為這是一項強有力的專利,我們將繼續大力捍衛我們的知識產權,特別是針對那些尚未在吉列尼亞。
Settlement discussions, of course, are ongoing.
當然,和解討論仍在進行中。
And we'll see where we land over the course of this year.
我們將在今年看到我們降落的地方。
Now on Lu-PSMA, John?
現在在 Lu-PSMA,約翰?
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes, I didn't ask -- I didn't hear the specific question.
是的,我沒有問——我沒有聽到具體的問題。
Could you repeat that, Andrew?
你能重複一遍嗎,安德魯?
Andrew Simon Baum - Global Head of Healthcare Research and MD
Andrew Simon Baum - Global Head of Healthcare Research and MD
Sure.
當然。
So you have your Phase III trial in patients unwilling or unable or failed chemotherapy, the large Phase III -- the name escapes me -- later this year, but you also have the THERAPY Phase II trial versus chemo.
因此,您將在今年晚些時候對不願或無法或失敗的患者進行 III 期試驗,大型 III 期試驗——這個名字讓我忘記了——但你也有治療 II 期試驗與化療的對比。
So my question was whether you could get approval for both indications, therefore broadening the initial label at the time of first launch.
所以我的問題是你是否能獲得這兩種適應症的批准,從而在首次推出時擴大初始標籤。
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes, thanks, Andrew.
是的,謝謝,安德魯。
For the VISION trial, we're actually looking at the later lines, and we would not get both indications because the second trial would actually come later.
對於 VISION 試驗,我們實際上是在查看後面的線路,我們不會同時得到這兩個跡象,因為第二次試驗實際上會更晚。
So our intent is through the VISION trial.
所以我們的意圖是通過 VISION 試驗。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes.
是的。
So we -- I think we'd expect to see first VISION, get that third, fourth line and then move into earlier lines of therapy as the other readouts happen.
所以我們 - 我認為我們希望看到第一個 VISION,得到第三、第四條線,然後隨著其他讀數的發生而進入更早的治療線。
I don't think we'd have data available to really enable us to get an even broader population at launch, at least that's our current expectation.
我認為我們沒有可用的數據來真正使我們能夠在發佈時獲得更廣泛的人口,至少這是我們目前的預期。
Operator
Operator
The next question comes from line of Tim Anderson from Wolfe Research.
下一個問題來自 Wolfe Research 的 Tim Anderson。
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
I just wanted to go back to Gilenya again.
我只是想再次回到Gilenya。
After Q3, management was felt to be on the road as being quite bullish that you would extend LOE and not have generic entry for years to come.
在第三季度之後,管理層被認為非常看好您將延長 LOE 並且在未來幾年內沒有通用條目。
And there's a sense now that perhaps you've backed away from that, maybe related to oral arguments recently.
現在有一種感覺,也許你已經放棄了這一點,可能與最近的口頭辯論有關。
So I'm wondering, just to simplify it, Vas, giving guidance to the analyst community, what would be a safe assumption for when we should expect LOE?
所以我想知道,為了簡化它,Vas,為分析師社區提供指導,當我們應該期待 LOE 時,什麼是安全的假設?
And second question is Sandoz.
第二個問題是 Sandoz。
You've previously talked about that, I think, as being a 3-year journey to turn it around, to reevaluate what to do with the division.
我認為,您之前曾談到過,這是一個 3 年的扭轉局面,重新評估如何處理該部門的旅程。
Maybe we're a year into that or slightly less.
也許我們已經完成了一年或更短的時間。
And I'm wondering if you can update us on long-term plans for that division.
我想知道您是否可以向我們介紹該部門的長期計劃。
It's performing.
它在表演。
We see that.
我們看到了。
But at the same time, it is a drag on growth, especially as the innovative pharma side of the business picks up and has momentum.
但與此同時,這也拖累了增長,尤其是在業務的創新製藥方面回暖並具有發展勢頭的情況下。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Tim.
謝謝,蒂姆。
Gilenya, unfortunately, I can't answer your question because I think it's difficult for us to know precisely.
Gilenya,不幸的是,我無法回答你的問題,因為我認為我們很難準確地知道。
What we are confident on is, we have a strong set of patents here that we're vigorously defending.
我們有信心的是,我們在這裡擁有一系列強大的專利,我們正在大力捍衛。
We're giving guidance so that you can all assume that no generic entrants in 2020.
我們正在提供指導,以便大家可以假設 2020 年沒有通用進入者。
And I think we'll know a lot more over the course of this year as we see the results of the IPR appeal, our own effort to strengthen the 405 patent with the IPR office, the District Court litigation that's ongoing; our 179 patent, which has now been granted.
而且我認為,隨著我們看到知識產權上訴的結果,我們自己與知識產權局加強 405 專利的努力,以及正在進行的地方法院訴訟,我們會在今年了解更多;我們的179項專利,現已獲得授權。
And we have filed infringement lawsuits on it.
我們已經對它提起了侵權訴訟。
And then of course the wildcard with all of that is, would someone attempt to launch at risk in various scenarios as well.
當然,所有這一切的通配符是,有人會嘗試在各種情況下冒險啟動。
So I think it's difficult, I think, to give a precise answer.
所以我認為很難給出一個準確的答案。
But I think what's really important is that, along with the 2020 guidance, we also are committed to delivering the margin expansion that we talked about, independent of when this happens.
但我認為真正重要的是,除了 2020 年的指導方針外,我們還致力於實現我們所討論的利潤率擴張,而與何時發生無關。
So that should give you -- all of you confidence, we believe, in the overall growth profile momentum and financial profile of the company.
因此,我們相信,你們所有人都應該對公司的整體增長勢頭和財務狀況充滿信心。
Now with respect to Sandoz, I -- yes, I'm very pleased with where we are in this journey to date.
現在關於 Sandoz,我 - 是的,我對我們迄今為止在這段旅程中所處的位置感到非常滿意。
I think we're on the right track.
我認為我們走在正確的軌道上。
I think we're committed to the business and continuing to drive the margins up to the mid 20s, which would put us in the range of our peer set over the coming years, continuing to strengthen the pipeline and portfolio, separating it in the company, so that it has the ability to compete very successfully.
我認為我們致力於業務並繼續將利潤率提高到 20 年代中期,這將使我們在未來幾年處於同行的範圍內,繼續加強管道和投資組合,將其在公司中分離,使其具有非常成功地競爭的能力。
Richard, do you want to just give some comments on where we are on the Sandoz strategy?
理查德,你想就我們在山德士戰略上的位置發表一些評論嗎?
Richard Saynor - CEO of Sandoz
Richard Saynor - CEO of Sandoz
Thank you, Vasant.
謝謝你,瓦桑特。
Yes.
是的。
I mean, clearly, a strong year in 2019.
我的意思是,很明顯,2019 年是強勁的一年。
We want to continue that momentum growing in 2020 and as Vas said, improve the margin journey as well.
我們希望在 2020 年繼續保持這種增長勢頭,正如 Vas 所說,我們也希望改善利潤率。
Also, a part of that is moving supply chain more within the Sandoz framework.
此外,其中一部分是將供應鏈更多地轉移到 Sandoz 框架內。
That gives us greater control of our costs and resource allocation and continuing to build our strength.
這使我們能夠更好地控制我們的成本和資源分配,並繼續增強我們的實力。
Clearly in Europe we're in the #1 position, taking market share, building a very strong and dynamic biologics portfolio.
顯然,在歐洲,我們處於第一的位置,佔據了市場份額,建立了一個非常強大和充滿活力的生物製劑產品組合。
The U.S. now re-based, much more focused in terms of growing on a much stronger injectable and specialty platform.
美國現在重新立足,更加專注於在更強大的注射劑和專業平台上發展。
And then emerging markets, closing the Aspen acquisition and integrating that into this quarter and then continue to build strong dynamic growth.
然後是新興市場,完成對 Aspen 的收購併將其整合到本季度,然後繼續建立強勁的動態增長。
So I think there's a lot of things that we're focused on that really support that agenda.
所以我認為我們關注的很多事情真正支持該議程。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes, so we'll keep you updated as Sandoz continues on the journey.
是的,所以隨著 Sandoz 繼續前進,我們會及時通知您。
And of course, if any of our perspectives change, we'll, of course, let you know.
當然,如果我們的任何觀點發生變化,我們當然會通知您。
Operator
Operator
Your next question comes from the line of Seamus Fernandez from Guggenheim.
您的下一個問題來自古根海姆的 Seamus Fernandez。
Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals
Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals
So 2 questions.
所以2個問題。
#1, can you just -- can you guys just update us on the trajectory for Beovu in the market?
#1,你們能不能——你們能給我們更新一下 Beovu 在市場上的發展軌跡嗎?
It looks like we're off to a good start.
看起來我們有了一個好的開始。
What we are hearing from some physicians, though, is that there are some questions being raised about the reimbursement dynamics in the market, and whether or not PRN utilization is something where they're struggling to get reimbursed if a patient is not getting the kind of benefits that they hoped early on.
不過,我們從一些醫生那裡聽到的是,有人對市場上的報銷動態提出了一些問題,如果患者沒有得到這種補償,PRN 的使用是否是他們難以獲得報銷的東西他們很早就希望得到的好處。
I know it's early on in the launch.
我知道它在發布的早期。
So just trying to get a better sense of, if that may be due to the J-code and lack of that in the early days, or just education that Novartis needs to do of the physician base for reimbursement.
所以只是試圖更好地了解,如果這可能是由於早期的 J 代碼和缺乏它,或者只是諾華需要對醫生基礎進行教育以報銷。
And the second question is, can you just help us understand the inclisiran agreement with the U.K.?
第二個問題是,你能不能幫助我們理解與英國的 inclisiran 協議?
I think there's a lot of confusion around this.
我認為這有很多混亂。
So just love to know the inputs with regard to distribution and really how this agreement is structured and the kind of revenue potential that you might see just from that type of an indication, and if this is something that Novartis is seeking to expand into this type of structure, Novartis would expand into other markets internationally or even in the U.S.
因此,只是想知道有關分銷的投入,以及該協議的結構以及您可能從這種類型的跡像中看到的收入潛力,以及諾華是否正在尋求將其擴展到這種類型結構上,諾華將擴展到國際甚至美國的其他市場
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Seamus.
謝謝你,西莫。
So first, on Beovu overall performance and profile, Marie-France?
那麼首先,關於 Beovu 的整體表現和形象,Marie-France?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Okay.
好的。
So I'll just say that overall we're extremely pleased with our launch of Beovu in the U.S. There's actually a very strong uptake.
因此,我只想說,總體而言,我們對 Beovu 在美國的推出感到非常滿意。實際上有非常強烈的吸收。
We've got 84% of retina specialists that have Beovu in their fridge.
我們有 84% 的視網膜專家的冰箱裡有 Beovu。
And actually, we got the J-code in record time.
實際上,我們在創紀錄的時間內獲得了 J 代碼。
So we -- there's a lot of confidence in the marketplace around the reimbursement and the benefits investigation experience.
所以我們 - 市場對報銷和福利調查經驗充滿信心。
We're also supporting physicians and providers and payers with a number of different initiatives, so that this will flow quite easily.
我們還通過許多不同的舉措為醫生、提供者和付款人提供支持,因此這將很容易進行。
You have to remember we've had the permanent J-code since the 1st of January.
您必須記住,我們從 1 月 1 日起就擁有了永久 J 代碼。
But so far, their benefits investigation and the reverifications have gone extremely well.
但到目前為止,他們的福利調查和重新驗證都非常順利。
What we're really excited about, though, is the feedback.
不過,我們真正興奮的是反饋。
So we get outstanding feedback from physicians regarding the efficacy and regarding the drying properties of Beovu.
因此,我們從醫生那裡得到了關於 Beovu 的功效和乾燥特性的出色反饋。
So we're very encouraged.
所以我們很受鼓舞。
We feel strongly that there is confidence in the marketplace around, not only the clinical experience so far, but also the experience around reimbursement.
我們強烈認為,市場對周圍的市場充滿信心,不僅是迄今為止的臨床經驗,還有關於報銷的經驗。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
In respect to inclisiran, the U.K. agreement, Marie-France?
關於inclisiran,英國協議,Marie-France?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
So the NHS partnership is made up of 3 memorandums of understanding.
因此,NHS 合作夥伴關係由 3 份諒解備忘錄組成。
The first one is really around a population health agreement in secondary prevention to enable broad access in the U.K. The second agreement is around a partnership for a primary prevention trial, and that is something that we would be working, not only with the U.K., but hopefully, other -- with other countries, obviously, with the intention of having a trial beyond just the U.K. And here, the intent would be much more to look at those patients who would be at high risk of having an event, but have not yet had an event.
第一個實際上是圍繞二級預防的人口健康協議,以便在英國廣泛使用第二個協議是圍繞初級預防試驗的合作夥伴關係,這是我們不僅要與英國合作,而且是希望,其他 - 與其他國家,顯然,旨在在英國以外進行試驗在這裡,意圖更多的是關注那些有高風險發生事件的患者,但沒有還舉辦了一場活動。
The third memorandum of understanding is around the collaboration and manufacturing, and this is really around the optimization to scale capacity.
第三個諒解備忘錄是圍繞協作和製造,這實際上是圍繞優化以擴大產能。
So these are 3 agreements [or intent of] agreement.
因此,這些是 3 個協議 [或協議的意圖]。
They're in preliminary phases, and we're obviously in conversations with the U.K. government around all 3.
它們處於初步階段,我們顯然正在與英國政府就這三個問題進行對話。
What is really interesting is this novel approach.
真正有趣的是這種新穎的方法。
And I think that's what we're very excited about because it is an opportunity for us to work with health care systems in a very different way.
我認為這就是我們非常興奮的原因,因為這是我們以非常不同的方式與醫療保健系統合作的機會。
We know LDL-cholesterol is a huge issue because of the lack of adherence, and we feel that with inclisiran, twice a year injected at a physician office, can really have the potential to increase that adherence and make a dent in CV disease and CV mortality over time.
我們知道,由於缺乏依從性,低密度脂蛋白膽固醇是一個大問題,我們認為每年在醫生辦公室注射兩次的 inclisiran 確實有可能增加這種依從性並減少 CV 疾病和 CV隨著時間的推移死亡率。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Maybe, Seamus, just on the modeling side of your question.
也許,Seamus,只是在你問題的建模方面。
And if you just think about the secondary prevention market in the -- or number of patients actually within -- in the U.K., there's about 1.8 million patients in the U.K. who would be eligible from a secondary prevention standpoint.
如果你只考慮英國的二級預防市場 - 或實際在其中的患者數量 - 從二級預防的角度來看,英國約有 180 萬患者符合條件。
The initial part of this memorandum of understanding, which we still have to, I think, fully get the final agreements around, would enable the treatment of multiple hundreds of thousands of patients.
這份諒解備忘錄的最初部分,我認為,我們仍然必須完全達成最終協議,這將使數十萬患者得到治療。
And then as data becomes more of -- from launch, I should say, and as data becomes more available, especially the outcome study in 2024, a potential to further expand that.
然後隨著數據變得越來越多——我應該說,從發布開始,隨著數據變得更加可用,尤其是 2024 年的結果研究,有可能進一步擴大這一點。
So there would be a clear commercial potential right from the start with inclisiran being broadly used in the U.K.
因此,隨著 inclisiran 在英國的廣泛使用,從一開始就有明顯的商業潛力。
I can't guide, obviously, to specific numbers, but we think it's -- we're highly attractive with respect to that launch.
顯然,我無法指導具體數字,但我們認為這是 - 我們對這次發布非常有吸引力。
And Marie-France and her team are very actively discussing now with payers in the U.S. as well as other parties around the world to see, can we use similar population-based agreements to drive significant volume uptake, even ahead of the outcome study?
Marie-France 和她的團隊現在正在與美國以及世界各地的其他各方非常積極地討論,我們是否可以使用類似的基於人口的協議來推動大量的交易量,甚至在結果研究之前?
Operator
Operator
Your next question comes from the line of Matt Weston from Crédit Suisse.
您的下一個問題來自瑞士信貸的 Matt Weston。
Matthew Weston - MD and Co-Head of European Pharmaceutical Equity Research
Matthew Weston - MD and Co-Head of European Pharmaceutical Equity Research
The first question, Vas, in your introductory comments, you flagged $1.5 billion of incremental efficiency gains.
第一個問題,Vas,在你的介紹性評論中,你提到了 15 億美元的增量效率收益。
You'd already raised margin guidance to mid- to high 30s with The Medicines Company deal.
通過與 The Medicines Company 的交易,您已經將利潤率指導提高到 30 多歲的中高水平。
So how should we interpret today's message?
那麼我們應該如何解讀今天的信息呢?
Is it now a target of even higher 30s?
現在是更高的 30 歲的目標嗎?
Or this new savings program helps achieve the previous goal?
或者這個新的儲蓄計劃有助於實現之前的目標?
Or are we looking for a large proportion to be reinvested in launches and innovation?
或者我們是否正在尋找將很大一部分再投資於發布和創新?
And then 2 other quick ones, if I can.
如果可以的話,還有另外兩個快速的。
Mitsubishi Tanabe, the Gilenya arbitration.
三菱田邊,Gilenya仲裁。
Can you just update us on timing, please, and when we should expect an outcome?
您能否向我們介紹時間安排以及我們何時應該期待結果?
And one for Susanne.
還有一個給蘇珊。
Lutathera, it previously had been flagged as a blockbuster opportunity, but sales now seem to have very much plateaued.
Lutathera,它以前被標記為一個重磅機會,但現在銷售似乎已經非常穩定了。
What's going to drive the inflection and when should we see it?
什麼會驅動拐點,我們什麼時候應該看到它?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Matthew.
謝謝你,馬修。
On the $1.5 billion, we really see this as a part of the ongoing journey to achieve the mid- to high 30s margin.
在 15 億美元中,我們確實將其視為實現 30 年代中高利潤率的持續旅程的一部分。
Harry, do you want to add any other details?
哈利,你想添加任何其他細節嗎?
Harry Kirsch - CFO
Harry Kirsch - CFO
Yes, Matthew, thank you for the question.
是的,馬修,謝謝你的問題。
So basically, we updated where we stand on the prior $2 billion productivity program that we announced 2 years ago, which we are completing end of 2020.
因此,基本上,我們更新了我們在 2 年前宣布的 20 億美元生產力計劃中的立場,我們將在 2020 年底完成該計劃。
And that was, of course, also supporting our short- and mid-term margin guidance.
當然,這也支持了我們的短期和中期利潤率指導。
This is also further supporting our margin expansion to the mid- to high 30s, so it's part of the overall program.
這也進一步支持我們將利潤擴大到 30 多歲的中高水平,因此它是整個計劃的一部分。
Of course, the growth drivers from the sales from the launches and market growth drivers as well as resource allocation and these ongoing continued efforts, mainly in technical operations, supply chain, but also NBS and procurement.
當然,增長動力來自於發布的銷售和市場增長動力以及資源配置以及這些持續不斷的努力,主要是在技術運營、供應鏈,但也包括國家統計局和採購。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Harry.
謝謝你,哈利。
And then on Mitsubishi Tanabe, we don't have any updates from where we last were on this.
然後在 Mitsubishi Tanabe 上,我們沒有任何更新。
We'll continue -- we're continuing that dialogue, and we'll of course, provide you an update if and when we have one.
我們將繼續 - 我們將繼續進行對話,當然,如果我們有更新,我們會為您提供更新。
And then with respect to Lutathera, Susanne?
然後關於 Lutathera,Susanne?
Susanne Schaffert - President of Novartis Oncology
Susanne Schaffert - President of Novartis Oncology
Yes.
是的。
So on Lutathera, actually, it is and will be one of the key growth drivers for the Oncology business.
所以在 Lutathera 上,實際上,它現在並且將是腫瘤業務的主要增長動力之一。
And overall, we're very pleased with the performance.
總的來說,我們對性能非常滿意。
We have, however, observed a slight deceleration in the growth in the U.S. Just remember that still, more than 80% of sales are coming from the U.S., and that's largely due to the reason that the major net centers that we focused on in the first round of our commercial efforts have now worked through the existing prevalence pool of cap net patients.
然而,我們觀察到美國的增長略有放緩 請記住,仍然有超過 80% 的銷售額來自美國,這主要是因為我們關注的主要網絡中心在我們的第一輪商業努力現已通過現有的 cap net 患者患病率池進行。
So now we focus on really tapping into earlier lines.
所以現在我們專注於真正挖掘早期的線路。
We have expanded our U.S. field force, now really targeting community centers and Tier 2 centers and should be very -- we were -- we are very optimistic actually.
我們已經擴大了我們的美國外勤部隊,現在真正針對社區中心和二級中心,應該非常——我們曾經——我們實際上非常樂觀。
We also should see now more sales coming from Europe as we got reimbursement in several key markets like France, Italy and Spain.
我們現在還應該看到更多來自歐洲的銷售,因為我們在法國、意大利和西班牙等幾個主要市場得到了報銷。
So overall we remain very confident on Lutathera.
所以總的來說,我們對 Lutathera 仍然非常有信心。
We still believe this has blockbuster potential and, as I said, still remain very optimistic about this product.
我們仍然相信這具有巨大的潛力,正如我所說,仍然對該產品非常樂觀。
Operator
Operator
Our next question comes from the line of Florent Cespedes from Societe General.
我們的下一個問題來自法國興業銀行的 Florent Cespedes。
Florent Cespedes - Senior Equity Analyst
Florent Cespedes - Senior Equity Analyst
Florent Cespedes from Societe General.
來自法國興業銀行的 Florent Cespedes。
Two quick questions.
兩個快速的問題。
First, ofatumumab, could you remind us what are the resources that you will use to push the U.S. launch in terms of sales force?
首先,ofatumumab,您能否提醒我們在銷售人員方面您將使用哪些資源來推動美國上市?
And will you use the Mayzent or Gilenya sales force as well?
您還會使用 Mayzent 或 Gilenya 銷售團隊嗎?
Or do you need to build new ones ahead of the launch?
還是您需要在發布之前構建新的?
My second question is more big picture regarding respiratory following [aferiperpid] results.
我的第二個問題是關於 [aferiperpid] 結果後的呼吸系統的更大圖景。
What is your strategy in the U.S. in terms -- in respiratory timetable in the U.S.?
就美國的呼吸時間表而言,您在美國的戰略是什麼?
Would you change your view on this therapeutical area?
你會改變你對這個治療領域的看法嗎?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
So Marie-France, on ofatumumab.
所以 Marie-France,關於ofatumumab。
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
So on ofatumumab, obviously we are resourcing to win, and we've got a strong focus on the U.S. also, given the fact that we have submitted a PRV.
所以在 ofatumumab 上,顯然我們正在為獲勝而提供資源,而且我們也非常關注美國,因為我們已經提交了 PRV。
We are looking to work with 2 separate sales forces, so 1 dedicated to ofatumumab.
我們正在尋求與 2 支獨立的銷售隊伍合作,因此 1 支專門用於 ofatumumab。
And then, of course, we have a sales force with Mayzent and Gilenya.
當然,我們還有 Mayzent 和 Gilenya 的銷售團隊。
So we will be resourcing to win in this marketplace.
因此,我們將提供資源以在這個市場上取勝。
As I said to you before in the presentation, we firmly believe that we have a very unique value proposition with ofatumumab, with unsurpassed efficacy in -- with B-cell depletion.
正如我之前在演講中對您所說的那樣,我們堅信我們對 ofatumumab 具有非常獨特的價值主張,在 B 細胞耗竭方面具有無與倫比的功效。
We've got an excellent safety profile and also the ease of administration will -- can really make this product a first-line choice for, not only centers of excellence, but just the general neurologists.
我們擁有出色的安全性和易於管理的特性——可以真正使該產品成為不僅是卓越中心,而且只是普通神經科醫生的一線選擇。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Great.
偉大的。
Thank you, Marie-France.
謝謝你,瑪麗-法蘭西。
On the respiratory strategy, what I'd say is, of course, [aferiperpid] was a big step back.
關於呼吸策略,我想說的是,當然,[aferiperpid] 是一大退步。
But we still have a significant global presence with Xolair.
但我們仍然在 Xolair 擁有重要的全球影響力。
Xolair is a major medicine for the company and obviously, a leading medicine for the treatment of atopic asthma.
Xolair 是該公司的主要藥物,顯然是治療特應性哮喘的領先藥物。
We've had a number of life cycle management opportunities with Xolair, both in Japan, the U.S. and in the EU.
在日本、美國和歐盟,我們與 Xolair 一起獲得了許多生命週期管理機會。
So Xolair remains a pillar.
所以 Xolair 仍然是一個支柱。
Ex U.S., we will, of course, have the inhaled range, which now will get expanded with the QVM and QMF approval.
在美國,我們當然會擁有吸入範圍,現在將隨著 QVM 和 QMF 的批准而擴大。
And then longer term, we have a pipeline within R&D, within development and research, that could address a broad range of a more specialty respiratory areas, including idiopathic pulmonary fibrosis, PAH, sarcoidosis.
從長遠來看,我們在研發、開發和研究中擁有一條管道,可以解決更廣泛的更專業的呼吸領域,包括特發性肺纖維化、PAH、結節病。
We have a program, a medicine called QBW, which is an oral medicine for COPD.
我們有一個項目,一種叫做 QBW 的藥物,它是一種治療 COPD 的口服藥物。
So a full range of assets in respiratory.
所以呼吸系統的資產種類齊全。
So I'd say right now, we're waiting to see how that pipeline matures.
所以我現在要說,我們正在等待這條管道如何成熟。
And in the meantime we focus on Xolair and our inhaled range.
與此同時,我們專注於 Xolair 和我們的吸入範圍。
Operator
Operator
Your next question comes from the line of Peter Welford from Jefferies.
您的下一個問題來自 Jefferies 的 Peter Welford。
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
Just 2 brief ones, please.
請只寫2個簡短的。
Firstly, just, I guess for Harry, on the corporate cost base.
首先,就公司成本而言,我猜對 Harry 而言。
And despite obviously, a lot of the cost-cutting cgoing through, which will be completed this year, we're still seeing around a mid-single digit increase in corporate SG&A costs year-on-year.
儘管很明顯,今年將完成大量削減成本的工作,但我們仍然看到企業 SG&A 成本同比增長約為中個位數。
Can you sort of provide some guidance perhaps as to how that might develop in the future, and whether or not we should see a change in that trend?
您能否就未來如何發展以及我們是否應該看到這種趨勢發生變化提供一些指導?
Secondly, then just for Richard, I wonder if you could give us any more visibility on the reasons behind the discontinuation of generic Advair.
其次,對於 Richard,我想知道您是否可以讓我們進一步了解通用 Advair 停產背後的原因。
Was this a decision based on regulatory discussions?
這是基於監管討論的決定嗎?
Or was this related to some other part of the product characteristics?
還是這與產品特性的其他部分有關?
And perhaps a question to ask Harry.
也許還有一個問題要問哈利。
I think I didn't see it in the release, but do we have the exact numbers for the Sandoz oral U.S. solids business, please.
我想我沒有在新聞稿中看到它,但是請提供 Sandoz 口服美國固體業務的確切數字。
We're being asked about sales and profits to take out of 2019.
我們被問及 2019 年的銷售額和利潤。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Great.
偉大的。
So thank you, Peter.
所以謝謝你,彼得。
Corporate costs, Harry?
公司成本,哈利?
Harry Kirsch - CFO
Harry Kirsch - CFO
On the corporate cost, I mean, first of all, let me start with all of our guidances, of course, include always also the corporate sector, even though it's a small part, when you add up, of course, Innovative Medicines and Sandoz.
關於企業成本,我的意思是,首先,讓我從我們所有的指導開始,當然,總是包括企業部門,即使它只是一小部分,當你加起來時,當然,Innovative Medicines 和 Sandoz .
So there are quite a few moving parts in that.
因此,其中有相當多的活動部分。
We expect, actually, for next year that the corporate cost part comes down and -- in the range of $50 million to $80 million.
實際上,我們預計明年公司成本部分會下降,並且在 5000 萬美元到 8000 萬美元之間。
But it's a bit more volatile because it's often -- so it's including some pension charges and other things, share-based compensation, all of that.
但它更不穩定,因為它經常 - 所以它包括一些養老金費用和其他東西,基於股票的薪酬,所有這些。
We're, therefore, a bit more volatile than maybe other parts of the business.
因此,我們可能比業務的其他部分更不穩定。
But we do see an overall reduction in the corporate cost line for core corporate cost as we go into 2020.
但是,隨著我們進入 2020 年,我們確實看到核心企業成本的企業成本線整體下降。
Maybe I should just add to it [on the pure increase].
也許我應該添加它[純粹增加]。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Certainly.
當然。
Go ahead.
前進。
Yes.
是的。
Harry Kirsch - CFO
Harry Kirsch - CFO
So we have footnoted that it's $1.1 billion in -- $1.2 billion in 2018 and $1.1 billion in 2019 on sales.
所以我們在腳註中指出,它的銷售額為 11 億美元——2018 年為 12 億美元,2019 年為 11 億美元。
I can't -- I just give you the exact numbers, then you have it, we will anyway once the deal is concluded, we will issue them for a set of pro forma financials.
我不能——我只是給你確切的數字,然後你就有了,無論如何,一旦交易完成,我們將發布一組備考財務數據。
So the net sales of this part of the business was $1.174 billion in 2018 and it's $1.072 billion in 2019.
因此,這部分業務的淨銷售額在 2018 年為 11.74 億美元,2019 年為 10.72 億美元。
In terms of core operating income, it was $294 million in '18, and it's now $272 million in 2019.
就核心營業收入而言,18 年為 2.94 億美元,2019 年為 2.72 億美元。
Now that sounds probably very low decline.
現在這聽起來可能非常低的下降。
It's, of course, helped that we stopped the depreciation and amortization.
當然,這有助於我們停止折舊和攤銷。
Of course, for core, the stop of depreciation is important.
當然,對於核心來說,停止貶值很重要。
And basically, the depreciation that didn't get booked was $9 million in 2018 and $26 million in 2019.
基本上,未入賬的折舊在 2018 年為 900 萬美元,在 2019 年為 2600 萬美元。
So if you add that back, then you have there a decline of 14% on the bottom line.
所以如果你把它加回來,那麼你的底線就會下降 14%。
But of course, when you compare the numbers, and when we give pro forma, the $272 million and $294 million for the 2 years in core operating income will be the ones that now are the public numbers.
但是,當然,當你比較這些數字時,當我們提供備考時,2 年核心營業收入的 2.72 億美元和 2.94 億美元將是現在公開的數字。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Good.
好的。
Thank you, Harry.
謝謝你,哈利。
And then generic Advair, Richard?
然後是通用的 Advair,Richard?
Richard Saynor - CEO of Sandoz
Richard Saynor - CEO of Sandoz
Thank you.
謝謝你。
So as you know, we received a CRL for a proposed Advair Gx in 2018 and our latest Q3 guidance that we would not be able to launch before H2 2020.
如您所知,我們在 2018 年收到了擬議 Advair Gx 的 CRL,以及我們無法在 2020 年下半年之前推出的最新第三季度指南。
Following a recent review of our data readouts, we no longer see a pathway to launch in the next 18 months.
在最近對我們的數據讀數進行審查之後,我們不再看到在未來 18 個月內推出的途徑。
And as a result, we've decided to discontinue further development.
因此,我們決定停止進一步的開發。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes, so -- and I think they're really much very data-driven, not necessarily from a regulatory feedback standpoint.
是的,所以——我認為它們真的非常受數據驅動,不一定從監管反饋的角度來看。
Operator
Operator
Your next question comes from the line of Stefan Schneider from Vontobel.
您的下一個問題來自 Vontobel 的 Stefan Schneider。
Stefan Schneider - Head of Life Sciences Team & Pharmaceutical Analyst
Stefan Schneider - Head of Life Sciences Team & Pharmaceutical Analyst
Vas, you showed us on Slide 23 that in-line products and pipeline would sustain long-term growth for the company.
Vas,您在幻燈片 23 上向我們展示了在線產品和管道將維持公司的長期增長。
What do you project for your bolt-ons, which were on an annual basis for $10 billion?
您對每年 100 億美元的附加項目有何計劃?
Do you still need that to drive long-term growth?
你還需要它來推動長期增長嗎?
And the other one is, what about share buybacks in that context?
另一個問題是,在這種情況下股票回購呢?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes.
是的。
Harry, do you want to just go through our capital allocation priorities?
哈利,你想看看我們的資本分配優先事項嗎?
And I can comment in a little more detail on M&A.
我可以更詳細地評論併購。
Harry Kirsch - CFO
Harry Kirsch - CFO
Yes, sure.
是的,當然。
Stefan, I mean our capital allocation priorities have not changed.
Stefan,我的意思是我們的資本配置優先級沒有改變。
So I think most of you know them.
所以我想你們大多數人都認識他們。
I should repeat them: so the first being investments in attractive organic growth opportunities; the second being to growing dividend, and we're -- assuming AGM approval, we will pay out $7 billion early March to all of our shareholders in totality; and then third would be the M&A, bolt-on acquisitions, where we see usually in the range of roughly 5%.
我應該重複一遍:首先是投資有吸引力的有機增長機會;第二個是增加股息,如果股東周年大會獲得批准,我們將在 3 月初向所有股東支付 70 億美元;然後是第三個是併購,補強收購,我們通常看到在大約 5% 的範圍內。
That's not a formula.
這不是一個公式。
We go by it whatever the opportunities are, but I think it's mainly to indicate we are not after large M&A; last but not least would be share buybacks.
有什麼機會我們就順其自然,但我認為這主要是為了表明我們不追求大併購;最後但並非最不重要的是股票回購。
And we completed last year $5 billion share buyback that we started in the middle of 2018.
我們去年完成了 2018 年年中開始的 50 億美元股票回購。
Now given also we bought The Medicines Company for $9.7 billion.
現在我們也以 97 億美元收購了 The Medicines Company。
We will finance it.
我們將資助它。
Of course, share buyback, at the moment, we do not see an additional one.
當然,股票回購,目前我們看不到額外的。
So we haven't announced it.
所以我們還沒有公佈。
Therefore, whenever we would do an additional share buyback, we would announce it.
因此,每當我們進行額外的股票回購時,我們都會宣布。
We have a standing commitment that we always buy back employee participation programs.
我們有一個長期承諾,即我們始終回購員工參與計劃。
So we never dilute our shareholders with employee programs.
因此,我們從不通過員工計劃稀釋我們的股東。
And that's, of course, an ongoing buyback that comes that we do without announcing it, but a specific share buyback program at the moment is not announced.
當然,這是我們在沒有宣布的情況下進行的持續回購,但目前尚未宣布具體的股票回購計劃。
I do expect that share buybacks will be always part of our capital allocation, but it's also the fourth priority.
我確實希望股票回購將始終是我們資本配置的一部分,但這也是第四個優先事項。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Harry.
謝謝,哈利。
And I think with respect to bolt-on M&A, I mean, when I look at this chart, what I see is the power of Novartis' internal R&D.
而且我認為關於補強併購,我的意思是,當我查看這張圖表時,我看到的是諾華內部研發的力量。
And we appropriately supplement it with M&A, but we're never in a position where we need to do or have to do M&A.
我們通過併購適當地補充它,但我們從來沒有處於需要或必須進行併購的位置。
We do it based on attractive assets that fit with our M&A strategy.
我們基於符合我們併購戰略的有吸引力的資產來做到這一點。
And then if we can have very strong economics beyond the acquisition, then of course we do them.
然後,如果我們能夠在收購之外擁有非常強大的經濟,那麼我們當然會這樣做。
So [we're feeling] very good about our overall profile and the strength of our internal R&D engine.
所以[我們感覺]對我們的整體形象和我們內部研發引擎的實力非常好。
Operator
Operator
The next question comes from the line of Richard Parkes from Deutsche Bank.
下一個問題來自德意志銀行的 Richard Parkes。
Richard J. Parkes - Director
Richard J. Parkes - Director
Firstly on Cosentyx, you obviously raised your peak sales guidance.
首先在 Cosentyx 上,您顯然提高了最高銷售指導。
But if we look at the Q-on-Q volume growth in the U.S., it's slowed a bit, and it sounds like you're talking about maintained rather than improved commercial access for 2020.
但是,如果我們看一下美國的 Q-on-Q 銷量增長,它會有所放緩,聽起來您在談論 2020 年的商業准入,而不是改善。
I know historically we've seen a soft Q1 with an acceleration as you've benefited from improved volumes.
我知道從歷史上看,我們已經看到第一季度的疲軟加速,因為您受益於銷量的提高。
I wonder if we should expect that again this year?
我想知道今年我們是否應該再次期待這一點?
Or are we in more of an equilibrium with an acceleration more dependent on new approvals?
或者我們是否處於更多的平衡狀態,加速更依賴於新的批准?
That's the first question.
這是第一個問題。
Second, I just wondered if Harry could talk about the swing factors to the upper and lower end of guidance.
其次,我只是想知道 Harry 是否可以談談指導上限和下限的擺動因素。
Consensus is already at the -- pretty much at the top end of the guidance.
共識已經在 - 幾乎處於指導的頂端。
So I wondered if there's anything maybe that we're not considering.
所以我想知道是否有什麼我們沒有考慮到的。
Or is your range, would you see that as a conservative kind of start for the year?
或者是你的範圍,你認為這是一個保守的今年開始嗎?
Final question is just a clarification.
最後一個問題只是一個澄清。
There's a few products where U.S. sales have significantly exceeded the IQVIA volume growth in the quarter, including Entresto, Promacta and Gilenya.
有一些產品在美國的銷售額在本季度顯著超過了 IQVIA 的銷量增長,包括 Entresto、Promacta 和 Gilenya。
I just wondered if you could talk, give us some insight on trends in pricing mix and stocking changes impacting those products.
我只是想知道您是否可以談談,讓我們了解影響這些產品的定價組合和庫存變化趨勢。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Richard.
謝謝你,理查德。
So first on Cosentyx dynamics, Marie-France?
那麼首先介紹 Cosentyx 動力學,Marie-France?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
So let me try and take parts of your question.
所以讓我試著回答你的部分問題。
So let me maybe address the Q4/Q1 transition.
所以讓我來談談第四季度/第一季度的過渡。
So yes, we do expect the typical Q1 seasonality, and we'll probably see that across the industry.
所以是的,我們確實預計第一季度的典型季節性,我們可能會在整個行業中看到這一點。
We actually aim to be broadly in line with Q4, potentially with a small deviation.
我們實際上的目標是與第四季度大體保持一致,可能會有小的偏差。
But we wouldn't see a very, very large deviation.
但我們不會看到非常非常大的偏差。
With your access question, we remain very focused on first- and second-line access.
對於您的訪問問題,我們仍然非常關註一線和二線訪問。
And obviously the incremental RDs as usual to make sure that happens.
顯然,像往常一樣增加 RD 以確保發生這種情況。
We feel very confident about where we are in access.
我們對我們所處的位置非常有信心。
There have been some changes, but we are in a solid first- and second-line position in the U.S.
發生了一些變化,但我們在美國處於穩固的一線和二線位置。
I'd just like to remind that we've continued and we've sustained growth through multiple competitor entries, and we see Cosentyx relatively untouched by new competitors coming in the marketplace.
我只想提醒一下,我們一直在繼續,並且通過多個競爭對手的進入保持了增長,我們看到 Cosentyx 相對沒有受到市場上新競爭對手的影響。
If I just give you an example, so in the U.S., we're outperforming both in dermatology and rheumatology.
如果我只是給你舉個例子,那麼在美國,我們在皮膚病學和風濕病學方面的表現都優於其他國家。
But if I take the dermatology market, we grew 27% this year versus the marketplace at 12%.
但如果我拿皮膚科市場來說,今年我們增長了 27%,而市場增長了 12%。
And if we look at quarter 4, it's 27% with the marketplace growing at 14%.
如果我們看第四季度,它是 27%,市場增長了 14%。
We're very confident in Cosentyx' product profile.
我們對 Cosentyx 的產品資料非常有信心。
But I think what's more important is that physicians are really confident with Cosentyx' products profile.
但我認為更重要的是醫生對 Cosentyx 的產品資料非常有信心。
If we look at PSO, we provide complete treatment.
如果我們看 PSO,我們會提供完整的治療。
Cosentyx is great on skin, but it is a complete treatment.
Cosentyx 對皮膚很好,但它是一種完整的治療方法。
2/3 of patients will have additional manifestations on nail, scalp and palmoplantar, and we do propose a very strong value proposition.
2/3 的患者會在指甲、頭皮和掌蹠部位出現其他表現,我們確實提出了非常強大的價值主張。
What's also important is that payers want an IL-17 on their formulary.
同樣重要的是,付款人希望他們的處方集上有 IL-17。
And so we're in a very good position to keep our market position.
因此,我們處於一個非常好的位置來保持我們的市場地位。
We're also leaders in the rheum space.
我們也是大黃領域的領導者。
So that's why we've upped our guidance based on the momentum and also on the additional news flow that we expect in the future.
這就是為什麼我們根據勢頭以及我們對未來預期的額外新聞流提高了我們的指導。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Marie-France.
謝謝你,瑪麗-法蘭西。
And I always think people should remind themselves Cosentyx has almost 45% of its sales now coming from rheumatology, fast growth.
而且我一直認為人們應該提醒自己 Cosentyx 現在有近 45% 的銷售額來自風濕病,快速增長。
And there, of course, we face minimal competition and continue to have an outstanding profile that we expand with additional indications.
當然,在那裡,我們面臨著最小的競爭,並繼續擁有出色的形象,我們通過其他跡象進行擴展。
And Marie-France and her team are doing an outstanding job.
Marie-France 和她的團隊做得非常出色。
So we feel very good with where we are on Cosentyx.
所以我們對我們在 Cosentyx 上的位置感覺非常好。
So on guidance, Harry?
所以在指導上,哈利?
Harry Kirsch - CFO
Harry Kirsch - CFO
Yes.
是的。
I think Richard, you asked about what are the potential swing factors.
我想理查德,你問了潛在的搖擺因素是什麼。
I mean I think in the end all what we discussed here, it's the 3 key elements on the top line, I think our key growth drivers in market are well established, and that is not so much of a swing factor in my mind.
我的意思是,我認為最終我們在這裡討論的所有內容,都是最重要的三個關鍵要素,我認為我們在市場上的主要增長動力已經確立,這在我看來並不是一個搖擺不定的因素。
Of course, the launches.
當然,發射。
We have some key launches.
我們有一些重要的發布。
And there's always a range, how fast will it be if we tick up.
而且總有一個範圍,如果我們打勾,它會有多快。
It's a great start.
這是一個很好的開始。
And other key launches that are driving onco and pharma.
以及其他推動 onco 和 pharma 的重要發布。
So it's a bit the range of outcome on the launches.
所以這有點像發布的結果範圍。
The second piece is, of course, then the productivity part.
第二部分當然是生產力部分。
There, we are very confident.
在那裡,我們非常有信心。
We are slightly ahead of our $2 billion program to be finalized this year.
我們比今年完成的 20 億美元計劃稍早一些。
The next program is there, but that's completely under our control, and that's going extremely well.
下一個程序就在那裡,但這完全在我們的控制之下,而且進展非常順利。
The third element is then the potential generic entries.
第三個元素是潛在的通用條目。
And we have now in the U.S., basically, Exjade/Jadenu the world competition entering in November, on Afinitor, the 3 lower strengths, not yet the higher strength, and then Travapost.
我們現在在美國,基本上,Exjade/Jadenu 是 11 月進入的世界比賽,在 Afinitor 上,3 個較低的強度,而不是較高的強度,然後是 Travapost。
Another element, of course, will be how quickly are [the various] large generic suppliers resubmitting.
當然,另一個因素是 [各種] 大型仿製藥供應商重新提交的速度有多快。
Some of them are back in the market.
其中一些又回到了市場。
And we would expect that Diovan and Exforge decline in 2020.
我們預計 Diovan 和 Exforge 將在 2020 年下降。
Now if there are some other smaller products in ophtha and pharma.
現在,如果在 ophtha 和 pharma 中還有其他一些較小的產品。
Of course, it could be that these come a bit later.
當然,這些可能會晚一點。
Then we talk about the higher end and also if our launches overperform, we talk at the higher end of the guidance.
然後我們談論高端,如果我們的發布表現超出預期,我們會談論指導的高端。
So it's the usual, let's say, set of swing factors.
所以這是通常的,比方說,一組擺動因素。
But overall, very confident in the top line growth.
但總體而言,對收入增長非常有信心。
A bit more on this uncertainty, what generics outside of Gilenya and [Xaflar] which are out of our guidance, and the other smaller products, when are they coming in.
關於這種不確定性的更多信息,Gilenya 和 [Xaflar] 之外的哪些仿製藥不在我們的指導範圍內,以及其他較小的產品何時上市。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Harry.
謝謝你,哈利。
And then I think on the last question on the IQVIA mismatch, probably we can't comment on why the data missed.
然後我想關於 IQVIA 不匹配的最後一個問題,我們可能無法評論數據丟失的原因。
But in terms of Entresto dynamics and then in terms of Kisqali and Taf/Mek the dynamics, maybe first, Marie-Francedo you want to comment on Entresto momentum in the U.S.?
但就 Entresto 的動態而言,然後是 Kisqali 和 Taf/Mek 的動態,也許首先,Marie-France 你想評論一下 Entresto 在美國的勢頭嗎?
And then Susanne, you can comment on the onco portfolio?
然後是 Susanne,您可以對 onco 產品組合發表評論嗎?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
So as you saw before, the momentum for Entresto is extremely strong.
如您之前所見,Entresto 的發展勢頭非常強勁。
And it's really based on demand.
它確實基於需求。
As I said before, the NBRxs are at an all-time high in the U.S. We've seen a fantastic quarter 4, and we expect that momentum to continue through 2020.
正如我之前所說,NBRx 在美國處於歷史最高水平。我們已經看到了出色的第 4 季度,我們預計這種勢頭將持續到 2020 年。
We're very encouraged by the fact that we have very strong data both in supporting ambulatory initiations, both in-hospital initiations.
我們非常鼓舞的是,我們擁有非常強大的數據來支持門診啟動,無論是在醫院啟動。
We have strong endorsement from the guidelines.
我們得到了指導方針的強烈支持。
So from ACC, AHA and ESC.
所以來自 ACC、AHA 和 ESC。
And also, we've got opportunities to grow in the future in China and Japan.
而且,我們未來在中國和日本也有發展的機會。
So I think we're poised to do really well with Entresto this year.
所以我認為今年我們準備好在 Entresto 上做得很好。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Marie-France.
謝謝你,瑪麗-法蘭西。
And volume dynamics, Susanne?
和音量動力學,蘇珊?
Susanne Schaffert - President of Novartis Oncology
Susanne Schaffert - President of Novartis Oncology
Yes.
是的。
I think also on the oncology portfolio in the U.S., very, very strong, accelerated growth on Kisqali.
我還認為在美國的腫瘤學產品組合中,Kisqali 的增長非常非常強勁。
And I think Richard, you pointed out Promacta.
我認為理查德,你指出了 Promacta。
Actually there, we see continued strong growth in ITP and also very strong uptake in first-line SAA.
實際上,我們看到 ITP 持續強勁增長,一線 SAA 也非常強勁。
We also had very favorable guidelines published at ASH, putting Promacta favorable versus Revlimid.
我們還在 ASH 上發布了非常有利的指南,使 Promacta 與 Revlimid 相比更有利。
So continued growth there and very pleased with the momentum.
因此,那裡的持續增長並對勢頭感到非常滿意。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
So overall, Richard, I'd say it's not stocking or other effects.
所以總的來說,理查德,我會說這不是放養或其他影響。
This is real demand growth that we're seeing on our key brands.
這是我們在主要品牌上看到的真實需求增長。
Operator
Operator
Your next question comes from the line of Keyur Parekh from Goldman Sachs.
您的下一個問題來自高盛的 Keyur Parekh。
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
The first one is, Vas, last year, Novartis started by guiding to operating profit for the Innovative Medicines business to grow at mid- to high single digits, and you ended the year delivering 17%.
第一個是 Vas,去年,諾華公司開始引導創新藥物業務的營業利潤以中高個位數增長,到年底實現了 17%。
Can you help us think about what might be the factors that might prevent you from doing similar levels of growth or a similar kind of momentum as we look at 2020?
您能否幫助我們思考一下哪些因素可能會阻止您在 2020 年實現類似的增長水平或類似的勢頭?
That's question #1.
那是問題#1。
Question #2, relative to inclisiran, and you spoke about the NHS kind of memorandum of understanding being hundreds of thousands of patients to begin with.
問題 #2,相對於 inclisiran,您談到了 NHS 的那種諒解備忘錄,一開始就有數十萬患者。
The highest-selling medicine in the U.K. prior to inclisiran would have been HUMIRA, at about GBP 400 million in NHS spend.
在 inclisiran 之前,英國最暢銷的藥物是 HUMIRA,NHS 的支出約為 4 億英鎊。
As one thinks about potential market pricing for inclisiran, with the kind of population numbers we are talking about, how likely is it that inclisiran is not the biggest-selling medicine in the U.K.?
當人們考慮到 inclisiran 的潛在市場定價時,考慮到我們正在談論的那種人口數量,inclisiran 不是英國最暢銷的藥物的可能性有多大?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
My first comment, Keyur, is your questions are extremely like entrapment, I feel like.
我的第一條評論,Keyur,我覺得你的問題非常像陷阱。
So I will do my best to answer them.
所以我會盡力回答他們。
On the overall momentum, as Harry said, of course we have tremendous momentum on our growth brands, on our launches.
正如哈利所說,就整體勢頭而言,我們的增長品牌當然有巨大的動力,我們的推出。
I think the key difference between 2020 and 2019 is that we do have the Exjade and Afinitor generics coming in.
我認為 2020 年和 2019 年之間的主要區別在於我們確實有 Exjade 和 Afinitor 仿製藥進入。
We also have the ophtha mature portfolio with generic exposure, and there's just a range of different outcomes for those brands.
我們還擁有具有仿製藥曝光率的成熟的 ophtha 產品組合,這些品牌只有一系列不同的結果。
And on the upside, of course, if our launch brands deliver or over-deliver our aspirations, they would more than offset them.
當然,從好的方面來說,如果我們的發布品牌實現或過度實現我們的願望,它們將遠遠抵消它們。
So that's why we gave the range that we've given at the start of this year to be prudent, and then we'll, of course, update as we -- as the year progresses, and we have a better read on some of these key launches that are currently ongoing.
所以這就是為什麼我們給出了我們在今年年初給出的範圍是謹慎的,然後我們當然會隨著時間的推移而更新——隨著時間的推移,我們會更好地閱讀一些這些目前正在進行的關鍵發布。
Now on -- with respect to inclisiran, it's certainly our aspiration that we would want to make it one of the largest medicines, or if not the largest medicine, in the history of the NHS.
現在,關於 inclisiran,我們當然希望它成為 NHS 歷史上最大的藥物之一,或者如果不是最大的藥物。
So we have many steps to get there.
所以我們有很多步驟可以到達那裡。
We have to get the medicine approved.
我們必須讓藥物獲得批准。
We have to arrive at the final agreement with the U.K. at NICE.
我們必須在 NICE 與英國達成最終協議。
And then ultimately, we need to drive significant uptake within the NHS system, which will require Marie-France and her team to do a lot of work to ensure that patients are diagnosed and ultimately get the medicine.
然後最終,我們需要在 NHS 系統內推動大量吸收,這將需要 Marie-France 和她的團隊做大量工作,以確保患者得到診斷並最終獲得藥物。
The good news and what we're excited about, is the commitment of the NHS to work together with us to drive that uptake, which is what we feel like on the first part of this agreement is truly unprecedented for the Head of the NHS and myself to sit together and discuss the introduction of a medicine into the NHS system.
好消息是我們感到興奮的是 NHS 承諾與我們合作以推動這種吸收,這就是我們在該協議的第一部分中認為對於 NHS 負責人和我自己坐在一起討論將藥物引入 NHS 系統的問題。
And the goal of driving large-scale utilization together, including the NHS, directly working on driving that utilization themselves.
以及共同推動大規模利用的目標,包括 NHS,直接致力於推動這種利用。
I think this shows the potential of this medicine to impact what is the leading cause of death and disability for health care systems.
我認為這表明這種藥物有可能影響醫療保健系統死亡和殘疾的主要原因。
So there's a huge desire.
所以有很大的慾望。
I've been genuinely impressed by the partnership that we've seen with the U.K. NHS and relevant U.K. government agencies on this.
我們與英國 NHS 和相關英國政府機構在這方面的合作給我留下了深刻的印象。
And what they're hopeful now is that we can hope -- replicate it in other geographies and hopefully in other systems in the U.S. as well.
他們現在希望的是,我們可以希望——在其他地區復制它,並希望在美國的其他系統中復制。
(Operator Instructions)
(操作員說明)
Operator
Operator
Your next question comes from the line of Laura Sutcliffe from UBS.
您的下一個問題來自瑞銀的 Laura Sutcliffe。
Laura Sutcliffe - Equity Research Analyst
Laura Sutcliffe - Equity Research Analyst
It is 1 question with 2 subparts.
這是 1 個問題,有 2 個子部分。
For the assets going to Aurobindo, do you see any further risks to the execution time line?
對於流向 Aurobindo 的資產,您認為執行時間線是否有進一步的風險?
And have there been any changes to what you're actually going to be able to dispose of there?
您實際上能夠在那里處理的東西是否有任何變化?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Richard?
理查德?
Thank you, Laura.
謝謝你,勞拉。
Richard Saynor - CEO of Sandoz
Richard Saynor - CEO of Sandoz
We are confident we'll close this quarter with moving in the direction we would expect to.
我們有信心在本季度結束時朝著我們預期的方向前進。
We're working closely with Aurobindo and the FTC to close that off, and there shouldn't be any surprises.
我們正在與 Aurobindo 和 FTC 密切合作以關閉它,應該不會有任何意外。
Operator
Operator
Your next question comes from the line of Richard Vosser from JPMorgan.
您的下一個問題來自摩根大通的 Richard Vosser。
Richard Vosser - Senior Analyst
Richard Vosser - Senior Analyst
So just one about the tax rate.
所以只有一個關於稅率。
So just -- I think we had an idea that the tax rate might go up to in between a range of 16% to 17% because of some of the tax reform in Switzerland and maybe the U.S. So just thoughts on what's going on there to bring it in line for 2020, sort of 16%?
所以只是 - 我認為我們有一個想法,由於瑞士和美國的一些稅收改革,稅率可能會上升到 16% 到 17% 之間。所以想想那裡發生了什麼讓它在 2020 年達到 16%?
And how we should think about it going forward?
以及我們應該如何看待它的未來?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Harry?
哈利?
Harry Kirsch - CFO
Harry Kirsch - CFO
Right.
正確的。
Thank you, Richard.
謝謝你,理查德。
So it's, of course, always the core tax rates and the tax rates move around with a bit of different split of profits in the different geographies.
因此,當然,核心稅率和稅率總是隨著不同地區的利潤分配有所不同而變化。
We are differently taxed.
我們的徵稅方式不同。
So again, I was pleased that for 2020, we have an outlook that the tax rate of the core tax of 16% is realistic, right, basically in the range of last year.
所以我再次高興的是,2020年,我們有一個前景,16%的核心稅稅率是現實的,對,基本上在去年的範圍內。
At -- and then ongoing, there could be an increase in the range of the 16% to 17%, 17.5%.
在 - 然後持續進行時,可能會增加 16% 到 17%、17.5% 的範圍。
But we update really here year by year.
但是我們真的在這裡逐年更新。
And there's a lot going on the -- in the overall tax -- field of taxes.
在整個稅收領域,還有很多事情要做。
On the other hand, we feel that we have a very attractive tax rate and that we will continue to have a very attractive tax rate.
另一方面,我們認為我們的稅率非常有吸引力,並且我們將繼續擁有非常有吸引力的稅率。
Of course, it's with tax reform being embedded and approved last year is super helpful for that.
當然,去年嵌入和批准的稅收改革對此非常有幫助。
But it's very hard to give exact long-term outlooks on it, but I'm confident we'll continue to have a very attractive tax rate in the range of 16% to 17.5% in the long term.
但很難給出確切的長期前景,但我相信,從長遠來看,我們將繼續在 16% 至 17.5% 的範圍內保持非常有吸引力的稅率。
Operator
Operator
Your next question comes from the line of Eric Le Berrigaud from Bryan Garnier.
您的下一個問題來自 Bryan Garnier 的 Eric Le Berrigaud。
Eric Le Berrigaud - Managing Partner Equity & Research
Eric Le Berrigaud - Managing Partner Equity & Research
Yes.
是的。
So 1 question as well.
所以還有1個問題。
We understand clearly what is behind your assumption that Gilenya, there won't be any generic in 2020.
我們清楚地了解您假設 Gilenya 的背後原因,2020 年不會有任何仿製藥。
Maybe a word on would you also take the assumption that there won't be any Sandostatin generic in the U.S., since it seems that Teva is quite hopeful to get positively out of the CRL answer they got last year and to be in the market by the end of the first half.
也許你會假設美國不會有任何 Sandostatin 仿製藥,因為 Teva 似乎很有希望從他們去年得到的 CRL 答案中獲得積極的結果,並在上半場結束。
So could you give maybe some sensitivity of if that happens, does that change anything to your guidance?
那麼,如果發生這種情況,您能否給出一些敏感性,這是否會改變您的指導?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes.
是的。
Thank you, Eric.
謝謝你,埃里克。
On Sandostatin, we -- as you know, the -- there's been an ongoing effort to launch a generic on Sandostatin LAR, given its unique formulation since, I believe, 2006 or 2007.
在 Sandostatin 上,我們 - 如您所知,一直在努力推出一種仿製藥 Sandostatin LAR,因為我相信自 2006 年或 2007 年以來其獨特的配方。
It is a very complex formulation and a complex manufacturing process.
這是一個非常複雜的配方和復雜的製造過程。
We -- to our understanding, have not seen any activity in the channels to indicate a entrant.
我們 - 據我們了解,沒有在渠道中看到任何表明進入者的活動。
And so if and when that changes, we'll of course let you know and update our guidance appropriately.
因此,如果情況發生變化,我們當然會通知您並適當地更新我們的指導。
I don't know, Harry, if you want to comment on the level of impact?
我不知道,Harry,如果你想評論影響的程度?
Harry Kirsch - CFO
Harry Kirsch - CFO
You know the U.S. sales of [Xaflar] right?
你知道 [Xafar] 在美國的銷量嗎?
If you assume a mid-year, this would not be so material.
如果你假設年中,這不會那麼重要。
Of course, on both, there would be like Gilenya and Xaflar , then we would have to update.
當然,兩者都會有 Gilenya 和 Xafar ,然後我們必須更新。
But with Xaflar alone, assuming a mid-year U.S. entry would not change our guidance.
但僅就 Xafar 而言,假設年中進入美國不會改變我們的指導。
It's a big-enough range.
這是一個足夠大的範圍。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And I would also say, it's important to note, given the production challenges with Sandostatin LAR, I think this -- we expect this to more look like a biosimilar-type erosion as we've seen in Europe, where we've been able to hold very well our Sandostatin LAR share even in the face of entrants in Germany and a few other countries.
我還要說,重要的是要注意,鑑於 Sandostatin LAR 的生產挑戰,我認為 - 我們預計這更像是我們在歐洲看到的生物仿製藥類型侵蝕,我們已經能夠即使面對德國和其他一些國家的進入者,我們也能很好地保持我們的 Sandostatin LAR 份額。
Operator
Operator
Our next question is from the line of Naresh Chouhan from Intron Health.
我們的下一個問題來自 Intron Health 的 Naresh Chouhan。
Naresh Chouhan;Intron Health;Founder
Naresh Chouhan;Intron Health;Founder
Sorry.
對不起。
My question's just been answered.
我的問題剛剛得到回答。
Operator
Operator
Your next question comes the line of Mark Purcell from Morgan Stanley.
您的下一個問題來自摩根士丹利的 Mark Purcell。
Mark Douglas Purcell - Equity Analyst
Mark Douglas Purcell - Equity Analyst
Yes.
是的。
Cosentyx, 2 parts.
Cosentyx,2 部分。
On the first part, for nonradiographic AxSpA and the use of a PRV, clearly, you have confidence the opportunity here for the product is partly [erased] against how it's [spurred].
在第一部分,對於非射線照相 AxSpA 和 PRV 的使用,很明顯,您有信心這裡的產品機會被部分 [抹去] 反對它是如何 [刺激]。
Is this a reflection of patient cycling dynamics or subgroup data from the PREVENT study or just as a portfolio play you have from an entrenched formulary position?
這是否反映了來自 PREVENT 研究的患者循環動態或亞組數據,或者只是作為您從根深蒂固的處方位置獲得的投資組合遊戲?
Because in market, it seems it has incredibly strong data in this setting, on the face of it superior.
因為在市場上,它似乎在這種情況下擁有令人難以置信的強大數據,從表面上看它是優越的。
So just trying to understand, do payers and physicians want both the TNF and IL-17 approach?
所以只是想了解,付款人和醫生是否同時需要 TNF 和 IL-17 方法?
And then the related question, in terms of the IL-17A/IL-17S head-to-head trial that's expected this year versus Cosentyx from UCB's Bimekizumab.
然後是相關的問題,就預計今年與 UCB 的 Bimekizumab 的 Cosentyx 進行的 IL-17A/IL-17S 頭對頭試驗而言。
If you see superiority do you feel that will have any impact, given obviously IL-23, IL-17 as you said, physicians and payers want an example of both.
如果您看到優越性,您是否覺得這會產生任何影響,顯然 IL-23、IL-17 如您所說,醫生和付款人想要兩者的例子。
But if it's a head-to-head and a superior IL-17A for -- 17A-17F head-to-head study, would that have any impact on the psoriasis indication for Cosentyx as you expand into neuro-compensating indications?
但是,如果它是針對 17A-17F 頭對頭研究的頭對頭和優越的 IL-17A,當您擴展到神經補償適應症時,這會對 Cosentyx 的銀屑病適應症有任何影響嗎?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes, thanks for the question.
是的,謝謝你的提問。
On Cosentyx non-radiographic AxSpA, the reason we're excited is again, the mechanism here of IL-17A versus TNF molecules is it allows you to really target [entosionis] or the [MTCs at the] insertion points.
在 Cosentyx 非放射 AxSpA 上,我們再次感到興奮的原因是,IL-17A 與 TNF 分子的機制是它允許您真正靶向 [entosionis] 或 [MTCs at the] 插入點。
And we believe in the long run leads to slower progression of the disease.
我們相信從長遠來看會導致疾病進展緩慢。
And physicians, the reason you've had such a strong uptake in PSA and AS with IL-17a, and particularly Cosentyx, is because of that mechanism and the data we've been able to show across a range of different indications.
醫生們,您之所以在 PSA 和 AS 中對 IL-17a,尤其是 Cosentyx 有如此強烈的吸收,是因為這種機制和我們能夠在一系列不同適應症中展示的數據。
So we think versus a TNF option, patients will prefer IL-17a.
所以我們認為與 TNF 相比,患者會更喜歡 IL-17a。
Also there's an impressive safety profile.
還有一個令人印象深刻的安全配置文件。
Nonradiographic, you're moving into earlier lines of -- really an earlier line of therapy, so safety also matters.
非放射線照相術,您正在進入更早的治療線——實際上是更早的治療線,因此安全性也很重要。
So we think we'll have the right profile.
所以我們認為我們將擁有正確的個人資料。
We think given Cosentyx's overall strength in rheumatology, we want to expand the full indication range quickly.
我們認為,鑑於 Cosentyx 在風濕病學方面的整體實力,我們希望迅速擴大整個適應症範圍。
We have nonradiographic, then we have, as we've alluded in the R&D day, a broad range of 8 additional indications we're pursuing, primarily in rheumatology to really build out the base.
我們有非射線照相,然後我們有,正如我們在研發日所暗示的那樣,我們正在追求廣泛的 8 種其他適應症,主要是在風濕病學中,以真正建立基礎。
So that's very much the goal.
所以這就是我們的目標。
On IL-17A/F, look, we believe Cosentyx now has 6, 7 years of real-world data, has a broad label, has proven itself for physicians.
在 IL-17A/F 上,我們相信 Cosentyx 現在擁有 6、7 年的真實世界數據,擁有廣泛的標籤,已經為醫生證明了自己。
And so we are not particularly concerned about other IL-17 inhibitors now coming in 5, 6 years after with a single trial.
因此,我們並不特別擔心其他 IL-17 抑製劑現在會在 5 年、6 年後進行一次試驗。
I think, as Marie-France noted, we have been able to head off every single one of the entrants that have come in to say and lead -- leading all of you to say that the end of Cosentyx is near, and we have been able to keep growing.
我認為,正如 Marie-France 所指出的,我們已經能夠阻止每一個進來發言和領導的參賽者——讓你們所有人說 Cosentyx 的末日即將到來,我們已經能夠保持增長。
I think that speaks to the power of the medicine, and that's what we'll keep driving.
我認為這說明了藥物的力量,這就是我們將繼續推動的。
Operator
Operator
Your last question comes from the line of Simon Baker from Redburn.
您的最後一個問題來自 Redburn 的 Simon Baker。
Simon P. Baker - Head of Pharmaceutical Research
Simon P. Baker - Head of Pharmaceutical Research
Vas, you began the presentation with a very persuasive presentation on your commitment to Novartis's ESG philosophy and targets.
Vas,您以非常有說服力的演講開始了您對諾華 ESG 理念和目標的承諾。
The question is, how and when will you be able to persuade Sustainalytics to lift the red flag that they currently have on Novartis, which we know from talking from clients, is preventing some investors from holding your stock?
問題是,您將如何以及何時能夠說服 Sustainalytics 解除他們目前在諾華(Novartis)上的危險信號,我們從客戶那裡了解到,這正在阻止一些投資者持有您的股票?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
I appreciate the questions.
我很欣賞這些問題。
I mean we are very committed to demonstrating to MSCI, Sustainalytics and the relevant other firms the depth and breadth of our commitment to these topics.
我的意思是,我們非常致力於向 MSCI、Sustainalytics 和其他相關公司展示我們對這些主題的承諾的深度和廣度。
You'll see in the appendix of our Novartis In Society report the most comprehensive review of our position in all of these areas that we've ever done.
您將在我們的 Novartis In Society 報告的附錄中看到對我們在所有這些領域所做的立場的最全面審查。
We're doing an online system as well, to provide these agencies with all of the relevant facts.
我們也在做一個在線系統,為這些機構提供所有相關的事實。
We're working very hard to resolve the remaining -- topics we have from the past with respect to some of our legacy issues, and I'm optimistic we'll be able to get to a better place with the reports coming out later this year.
我們正在努力解決剩下的問題——我們過去的一些遺留問題,我很樂觀,我們將能夠在稍後發布的報告中取得更好的成績年。
It's certainly a top focus for me and our management team.
這當然是我和我們的管理團隊的首要關注點。
So hopefully, we'll be able to do that, and those investors then would be able to invest in our, we believe, great company.
因此,希望我們能夠做到這一點,然後這些投資者將能夠投資於我們相信的偉大公司。
Thank you all very much, and I appreciate you sticking around a little longer, and we'll look forward to providing you another update in a few months.
非常感謝大家,感謝你們多待一會兒,我們期待在幾個月後為你們提供另一個更新。
I wish you a great 2020, great start to the next decade.
祝您 2020 年有一個美好的開始,下一個十年有一個良好的開端。
And thank you for your interest in Novartis.
感謝您對諾華的關注。
Operator
Operator
That does conclude our conference for today.
這確實結束了我們今天的會議。
Thank you for participating and we will now disconnect.
感謝您的參與,我們現在將斷開連接。