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Operator
Operator
Good morning, and good afternoon, and welcome to the Novartis Q3 2020 Results Release Conference call and Live Audio Webcast.
早上好,下午好,歡迎來到諾華 2020 年第三季度業績發布會電話會議和現場音頻網絡直播。
(Operator Instructions) A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends.
(操作員說明)電話會議的錄音,包括問答環節,將在電話會議結束後不久在我們的網站上提供。
(Operator Instructions)
(操作員說明)
With that, I would like to hand the call over to Mr. Samir Shah, Global Head of Investor Relations.
有了這個,我想把這個電話轉給投資者關係全球負責人 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
Thank you very much, and thank you to everybody for participating in today's call, and we appreciate very busy day for you all as lots of companies are reporting earnings.
非常感謝大家,感謝大家參加今天的電話會議,我們感謝大家非常忙碌的一天,因為很多公司都在報告收益。
Before we start, I just want to read you the safe harbor statement.
在我們開始之前,我只想為您閱讀安全港聲明。
The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors.
今天提供的信息包含涉及已知和未知風險、不確定性和其他因素的前瞻性陳述。
These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.
這些可能導致實際結果與此類陳述所表達或暗示的任何未來結果、業績或成就存在重大差異。
For a description of some of these factors, please refer to the company's Form 20-F, its most recent quarterly results on Form 6-K that respectively were filed with and furnished to the U.S. Securities and Exchange Commission.
有關其中一些因素的描述,請參閱公司的 20-F 表格,該公司在表格 6-K 上的最新季度業績分別提交給美國證券交易委員會並提供給美國證券交易委員會。
And with that, I'll hand the call to Vas.
有了這個,我會把電話交給 Vas。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Samir, and thanks, everyone, from my side as well for joining today's conference call.
謝謝你,薩米爾,也謝謝我身邊的每一個人參加今天的電話會議。
With me today, are Harry Kirsch, our Chief Financial Officer; Marie-France Tschudin, our President of Novartis Pharmaceuticals; Susanne Schaffert, our President of Novartis Oncology; John Tsai, our Head of Global Drug Development; Richard Saynor, our CEO of Sandoz; and Shannon Klinger, our Chief Legal Officer.
今天和我在一起的是我們的首席財務官 Harry Kirsch; Marie-France Tschudin,我們的諾華製藥總裁; Susanne Schaffert,諾華腫瘤學總裁;我們的全球藥物開發主管 John Tsai;山德士首席執行官 Richard Saynor;和我們的首席法務官 Shannon Klinger。
So if we move to Slide 5, I'd like to start out by providing some perspectives on the third quarter.
因此,如果我們轉到幻燈片 5,我想首先提供一些關於第三季度的觀點。
As you saw, we delivered very solid results.
如您所見,我們提供了非常可靠的結果。
And I think it's important to put those results in the context of COVID-19 and the impact it's had on health care systems.
我認為將這些結果放在 COVID-19 及其對醫療保健系統的影響的背景下很重要。
Despite that impact and despite the impact to those health care system disruptions on some of our legacy brands, because of our key growth drivers, because of our execution on launches, we were able to deliver solid sales performance in line with Q3 of last year and 4% sales growth year-to-date and strong operating income performance, core operating income performance of 11% in the quarter and 16% year-to-date.
儘管存在這種影響,並且儘管這些醫療保健系統中斷對我們的一些傳統品牌產生了影響,但由於我們的主要增長動力,由於我們對發布的執行,我們能夠提供與去年第三季度一致的穩健銷售業績,並且年初至今銷售額增長 4%,營業收入表現強勁,本季度核心營業收入增長 11%,年初至今增長 16%。
As important was our ability to continue to deliver on our innovation agenda.
同樣重要的是我們有能力繼續實現我們的創新議程。
In the quarter, you saw important approvals, Kesimpta in the U.S. for relapsing forms of multiple sclerosis, multiple approvals for Cosentyx and Piqray and then some indication expansions as well for Xolair.
在本季度,您看到了重要的批准,美國 Kesimpta 用於復發性多發性硬化症, Cosentyx 和 Piqray 的多項批准,然後是 Xolair 的一些適應症擴展。
We had multiple positive readouts in Beovu in DME, ABL001 in CML and importantly, a range of readouts as well for LNP023, iptacopan, our factor B inhibitor, which we believe could be the next -- one of the next major medicines for Novartis.
我們在 DME 中的 Beovu、CML 中的 ABL001 中獲得了多個陽性讀數,重要的是,我們的 B 因子抑製劑 LNP023、iptacopan 也有一系列讀數,我們認為這可能是下一個——諾華的下一個主要藥物之一。
And we also achieved a positive CHMP opinion for Leqvio in hyperlipidemia and Adakveo for sickle cell disease.
我們還對 Leqvio 治療高脂血症和 Adakveo 治療鐮狀細胞病取得了積極的 CHMP 意見。
So a solid strong quarter really for delivering on innovation.
因此,一個堅實的強勁季度真正實現了創新。
There were also multiple important designations we received both for LNP023 and also for LMI070, an orphan drug designation for Huntington's disease.
我們還收到了 LNP023 和 LMI070(亨廷頓氏病的孤兒藥指定)的多個重要名稱。
And I'll say more about that in a couple of slides.
我將在幾張幻燈片中對此進行更多說明。
Moving to Slide 6. Turning to our growth drivers.
轉到幻燈片 6。轉向我們的增長動力。
There were strong performance across our key growth drivers.
我們的主要增長動力均表現強勁。
Some of the highlights include Entresto growing 45%, Zolgensma having a strong quarter with a strong uptake in Europe growing 79%, Cosentyx growing 7% ahead of a challenging market right now in dermatology, but still demonstrating its overall strength in both dermatology and rheumatology and exceeding $1 billion for the first time.
其中一些亮點包括 Entresto 增長 45%,Zolgensma 季度表現強勁,在歐洲的強勁吸收增長 79%,Cosentyx 增長 7%,領先於目前皮膚病學領域充滿挑戰的市場,但仍顯示其在皮膚病學和風濕病學方面的整體實力並首次超過 10 億美元。
And solid performance across the full range of our oncology portfolio.
在我們所有的腫瘤學產品組合中表現穩定。
You also see Mayzent beginning to accelerate and continued solid performance for launches such as Piqray as well as Lutathera.
您還可以看到 Mayzent 開始加速並在 Piqray 和 Lutathera 等發布方面繼續保持穩健的表現。
Now when you look overall at our key growth drivers, they're now accounting for 50% of our sales in the quarter in Q3.
現在,當您全面審視我們的主要增長動力時,它們現在占我們第三季度季度銷售額的 50%。
And I think that shows the transition from our legacy portfolio to our next wave of Innovative Medicines is well entrenched and continuing at pace.
而且我認為這表明從我們的傳統產品組合到我們下一波創新藥物的過渡是根深蒂固的,並且正在繼續進行。
Moving to Slide 7. I just wanted to say a word specifically on Zolgensma.
轉到第 7 張幻燈片。我只想特別談談 Zolgensma。
Zolgensma's cumulative sales since launch now has exceeded $1 billion.
Zolgensma 自推出以來的累計銷售額現已超過 10 億美元。
You can see on the left-hand side of the chart we achieved sales of $666 million year-to-date, with strong growth in Europe and also recovery in the U.S. Just to say a few more detailed words about the geographic highlights.
您可以在圖表的左側看到,我們今年迄今實現了 6.66 億美元的銷售額,其中歐洲增長強勁,美國也出現復甦。就地理亮點說幾句更詳細的話。
In the U.S., we saw a rebounding from the pandemic disruptions we saw throughout the summer as well as in the spring.
在美國,我們看到從整個夏季和春季看到的大流行中斷中反彈。
And that, I think, is allowing us to get patients tested again and then on treatment.
我認為,這使我們能夠讓患者再次接受檢測,然後接受治療。
74% of newborns are now being screened for SMA, and we see that rate continue to grow.
74% 的新生兒現在正在接受 SMA 篩查,我們看到這一比例還在繼續增長。
And of course, in states with newborn screening, Zolgensma tends to have very high shares.
當然,在進行新生兒篩查的州,Zolgensma 的份額往往很高。
We're also seeing overall shift to the incident population away from switches from nusinersen.
我們還看到從 nusinersen 轉向事件人群的整體轉變。
You can see 83% of our sales in Q3 were switches -- were new starts for -- from an incident population versus 34% in Q3.
您可以看到,我們在第三季度的銷售額中有 83% 是開關——是新的開始——來自事故人群,而第三季度這一比例為 34%。
In Europe, we're seeing very solid uptake.
在歐洲,我們看到了非常穩固的吸收。
9 EU countries have established access pathways that's already covering 25% of the population.
9 個歐盟國家已經建立了覆蓋 25% 人口的准入途徑。
The overall dynamic we see in the ex U.S. marketplace is as the country comes on board we see a bolus of patients come on to Zolgensma, then we move back to the steady state and then we get new countries on board.
我們在前美國市場上看到的整體動態是,隨著國家加入,我們看到大量患者加入 Zolgensma,然後我們回到穩定狀態,然後我們得到新的國家加入。
So in line with that, Germany delivered 50% of our ex U.S. sales in quarter 3. We continue to see very strong uptake in Germany.
因此,與此一致,德國在第三季度提供了我們在美國前銷售額的 50%。我們繼續看到德國非常強勁的吸收。
And now we'll expect to see multiple other countries start to come online in the coming quarters.
現在,我們預計在未來幾個季度將看到多個其他國家/地區開始上網。
The majority of the early patients are coming from prior treatment with nusinersen.
大多數早期患者來自先前接受過nusinersen的治療。
And over 30% of patients thus far have been over 2 years of age, given our broader label in the EU.
鑑於我們在歐盟的廣泛標籤,到目前為止,超過 30% 的患者已經超過 2 歲。
Now looking ahead, in Japan, we see rapid uptake with the immediate full reimbursement.
現在展望未來,在日本,我們看到立即全額報銷的迅速普及。
We've had an approval recently in Brazil, and we're expecting multiple approvals around the world.
我們最近在巴西獲得了批准,我們期待在全球範圍內獲得多項批准。
So we continue to believe ex U.S. will be a key driver.
因此,我們繼續相信前美國將成為關鍵驅動力。
The U.S. should stabilize now post the COVID situation, and we expect to reach a steady state on our U.S. sales, and we continue to expect Zolgensma to be a strong growth driver for Novartis.
在 COVID 局勢之後,美國現在應該穩定下來,我們預計我們的美國銷售將達到穩定狀態,我們繼續預計 Zolgensma 將成為諾華的強勁增長動力。
Now moving to Slide 8. Sandoz year-to-date sales were in line with prior year, and there were really 2 sides of the Sandoz story.
現在轉到幻燈片 8。山德士年初至今的銷售額與上一年持平,山德士的故事確實有兩個方面。
When you look at the biopharmaceutical sales on the right-hand side of the chart, you see that we grew 13% in Q3.
當您查看圖表右側的生物製藥銷售額時,您會看到我們在第三季度增長了 13%。
And in the 9 months year-to-date, we've grown 20% with biopharma, but primarily our biosimilars business.
在今年迄今為止的 9 個月中,我們的生物製藥業務增長了 20%,但主要是我們的生物仿製藥業務。
But you do see the drag of our retail sales, it was minus 6% in the quarter and minus 4% year-to-date.
但你確實看到了我們零售銷售的拖累,本季度為負 6%,年初至今為負 4%。
That's been primarily driven by an oral solid decline in the U.S. as COVID-19 has impacted patient traffic and also some similar dynamics we see in Europe as well as after the Southern Hemisphere flu season.
這主要是由於美國的口服固體下降,因為 COVID-19 影響了患者流量,以及我們在歐洲以及南半球流感季節之後看到的一些類似動態。
Now importantly, we've been able to maintain our profit trajectory with gross margin increases, both from a product mix and productivity reduced SG&A spend.
現在重要的是,我們已經能夠通過毛利率的增加來維持我們的利潤軌跡,無論是產品組合還是生產力降低的 SG&A 支出。
So overall, we have made some small adjustments to our Sandoz top line guidance.
所以總的來說,我們對山德士的頂線指導做了一些小的調整。
But overall, I feel good about our margin progression in Sandoz over the course of the year.
但總的來說,我對我們在 Sandoz 一年中的利潤增長感到滿意。
Now moving to Slide 9. I want to take a step back again and provide some perspective on the overall trajectory of the company and give you some details on some of our pipeline assets.
現在轉到幻燈片 9。我想再次退後一步,就公司的整體發展軌跡提供一些觀點,並為您提供一些關於我們的一些管道資產的詳細信息。
When you look at the outlook for the coming years, we continue to have strong end-market growth drivers.
當您展望未來幾年的前景時,我們將繼續擁有強大的終端市場增長動力。
We're in the midst of a range of major launches, multiple novel assets in our mid-stage pipeline.
我們正處於一系列重大發布之中,我們的中期管道中有多個新資產。
And I've been pleased to see multiple analyst reports now appreciating the depth and breadth of our mid-stage portfolio, which we believe is one of the best, if not the best in the industry, with 80 submissions planned, 50-plus late-stage programs.
我很高興看到多個分析師報告現在讚賞我們的中期投資組合的深度和廣度,我們認為這是最好的之一,如果不是業內最好的,計劃提交 80 份,逾期 50 多份-舞台節目。
And increasingly coming into focus as well will be our life cycle management program across many of our end-market growth drivers, as you can see on the right-hand side of this chart.
正如您在此圖表的右側所見,我們在許多終端市場增長驅動因素中的生命週期管理計劃也將越來越受到關注。
Now turning to Slide 10.
現在轉到幻燈片 10。
I wanted to provide some more detail.
我想提供更多細節。
And I'll go through the slide in a little bit of a slower pace, Slide 10, 11, just to make sure you have full clarity on where we are in the various pipeline elements.
我將以稍慢一點的速度瀏覽幻燈片,幻燈片 10、11,以確保您完全清楚我們在各種管道元素中的位置。
It's important to note that we are seeing on select instances delays due to COVID.
重要的是要注意,我們在某些實例上看到由於 COVID 造成的延遲。
And those COVID delays typically are in the range of 3 to 5 months.
這些 COVID 延誤通常在 3 到 5 個月之間。
We're transparently reflecting that in our documentation to all of you so you can see where we are.
我們在我們的文檔中向你們所有人透明地反映了這一點,這樣你們就可以看到我們在哪裡。
But overall, I think, relatively speaking, our portfolio has remained resilient and largely on track despite the massive disruption of COVID all around the world.
但總的來說,我認為,相對而言,我們的投資組合保持彈性,並且在很大程度上處於正軌,儘管全球範圍內 COVID 發生了大規模破壞。
Now with Leqvio, you've seen our EU positive CHMP opinion.
現在有了 Leqvio,您已經看到了我們對歐盟的積極 CHMP 意見。
In the U.S., we've completed the -- most part element of the review with the FDA, including the full clinical review.
在美國,我們已經完成了與 FDA 審查的大部分內容,包括完整的臨床審查。
The only outstanding item now is a single manufacturing inspection, which we're working with the agency on, on a facility in Italy.
現在唯一未完成的項目是一次製造檢查,我們正在與該機構合作,在意大利的一家工廠進行。
We've provided extensive documentation and currently work with the agency to try to maintain the action date of December 2020.
我們提供了大量文件,目前正在與該機構合作,努力維持 2020 年 12 月的行動日期。
On ofatumumab, you've seen, of course, the strong U.S. approval, and Marie-France will provide you more context.
在 ofatumumab 上,您當然已經看到了美國的強烈認可,而 Marie-France 將為您提供更多背景信息。
Our EU approval is planned in the first half of 2021.
我們計劃在 2021 年上半年獲得歐盟批准。
Now with respect to Entresto, 2 critical and important life cycle management and preserved ejection fraction and then the post MI.
現在關於 Entresto,2 關鍵和重要的生命週期管理和保留的射血分數,然後是 MI。
The FDA has released a notice today that we will have an AdCom for the preserved ejection fraction filing in December.
FDA 今天發布了通知,我們將在 12 月為保留的射血分數提交 AdCom。
We're fully preparing for that advisory committee and look forward to those discussions.
我們正在為該諮詢委員會做好充分準備,並期待這些討論。
The FDA action is -- it continues to be in the first quarter of next year.
FDA 的行動是——它繼續在明年第一季度。
Now with respect to AVXS-101 IT on the partial clinical hold, we continue to work on our proposed confirmatory clinical trial study, and we'll plan to engage with FDA.
現在關於部分臨床擱置的 AVXS-101 IT,我們繼續致力於我們提出的確認性臨床試驗研究,我們將計劃與 FDA 合作。
Our hope is that we can come up with a lean program that will enable us to move extremely quickly, but it would be premature to provide any guidance on time lines at this point in time.
我們希望我們能夠提出一個精益計劃,使我們能夠非常迅速地採取行動,但現在就時間線提供任何指導還為時過早。
So we don't have any further guidance on specific time lines on AVXS-101 IT.
因此,對於 AVXS-101 IT 的具體時間線,我們沒有任何進一步的指導。
And we'll continue to provide you updates as we continue those discussions with the FDA.
隨著我們繼續與 FDA 進行討論,我們將繼續為您提供更新。
There were a few notes this morning also noting the ligelizumab time line.
今天早上有一些筆記也注意到了 ligelizumab 的時間線。
We do expect the trial to read out on track, fully enrolled and to read out in the second half of next year.
我們確實希望該試驗能夠按計劃進行,完全註冊並在明年下半年宣讀。
However, given the COVID disruption, we are now forecasting that the submission would be pushed into the first part of 2022.
但是,鑑於 COVID 中斷,我們現在預測提交將被推遲到 2022 年上半年。
Then moving down the line.
然後下線。
The next item I wanted to highlight was canakinumab.
我想強調的下一個項目是 canakinumab。
Our CANOPY-1, as you know, enrollment is complete.
如您所知,我們的 CANOPY-1 已完成註冊。
The DMC did recommend a continuation after -- without change after the interim analysis.
DMC 確實建議在中期分析之後繼續 - 在不改變之後。
So we remain fully blinded to that study.
所以我們對這項研究仍然完全視而不見。
The full readout is expected in the second half of 2021.
完整的讀數預計在 2021 年下半年發布。
And similarly, CANOPY-2 is fully enrolled, and we expect to read out in the first half of 2021 for that program.
同樣,CANOPY-2 已完全註冊,我們預計將在 2021 年上半年公佈該計劃。
And lastly, I wanted to note on Kisqali that we did expand our adjuvant NATALEE study by 1,000 patients, learning from the recent readouts from some of our competitors, to ensure we maximize the success of this medicine in the adjuvant setting across both intermediate and high-risk patients.
最後,我想在 Kisqali 上指出,我們確實將我們的 NATALEE 輔助研究擴大了 1,000 名患者,從我們的一些競爭對手最近的讀數中學習,以確保我們在中等和高水平的輔助環境中最大限度地取得這種藥物的成功-風險患者。
As you know, there's a unique profile here with Kisqali, the most potent CDK4 inhibitor, which we believe is the most important in this setting, and also 3 years of treatment in this patient population with a 400-milligram dose lower than what we have in the metastatic setting to really ensure patients can stay on therapy.
如您所知,Kisqali 是最有效的 CDK4 抑製劑,我們認為它在這種情況下是最重要的,並且在這個患者群體中以低於我們現有的 400 毫克劑量進行了 3 年的治療。在轉移性環境中,真正確保患者可以繼續接受治療。
We're optimistic about this program and look forward to continuing to provide you updates as it progresses.
我們對該計劃持樂觀態度,並期待在其進展過程中繼續為您提供更新。
Now moving to Slide 11.
現在轉到幻燈片 11。
On the emerging pipeline assets, and many of these we'll provide more details on, on our upcoming Meet the Management.
關於新興的管道資產,其中許多我們將在即將到來的與管理層會面中提供更多詳細信息。
I had mentioned iptacopan.
我曾提到過 iptacopan。
I'll go through some more details in the next 2 slides.
我將在接下來的 2 張幻燈片中介紹更多細節。
But a range of positive feedback, including positive Phase II results in PNH and C3G.
但是一系列積極的反饋,包括積極的 II 期結果導致 PNH 和 C3G。
We're on track now to have a single PNH pivotal trial for the front line and combination study to start in 2020 as well as pivotal studies in both C3 glomerulopathy and IgA nephropathy to start in the first half of next year.
我們現在有望在 2020 年開始對一線和聯合研究進行單一 PNH 關鍵試驗,並在明年上半年開始對 C3 腎小球病和 IgA 腎病的關鍵研究。
Moving down the line, the other asset I wanted to spend a little bit of time on is branaplam, our mRNA splicing inhibitor, which we announced had received orphan drug designation for Huntington's disease.
往下走,我想花一點時間研究的另一項資產是 branaplam,我們的 mRNA 剪接抑製劑,我們宣布它已獲得亨廷頓病孤兒藥指定。
This was based on extensive preclinical data, which we expect to be published in the coming months as well as clinical data from our SMA trial, in which we were able to look at Huntington RNA expression.
這是基於廣泛的臨床前數據,我們預計將在未來幾個月內公佈這些數據,以及我們的 SMA 試驗的臨床數據,其中我們能夠觀察亨廷頓 RNA 的表達。
We believe branaplam's RNA splicing mechanism has a unique profile to be able to tackle Huntington's disease as a potentially once weekly, we'll have to see the final dosing, oral therapy.
我們相信,branaplam 的 RNA 剪接機制具有獨特的特徵,能夠以每週一次的方式治療亨廷頓氏病,我們將不得不看到最終的劑量,即口服治療。
And we'll plan to start that Huntington's disease Phase IIb in the first part of 2021.
我們計劃在 2021 年上半年啟動亨廷頓病 IIb 期。
Now in terms of oncology, probably the one asset I wanted to spend a moment to highlight was our SHP2 inhibitor that is in a broad range of combination studies, multiple combination studies with spartalizumab, Kisqali and nazartinib as well as Mirati's G12C.
現在就腫瘤學而言,我想花一點時間強調的一項資產可能是我們的 SHP2 抑製劑,它在廣泛的聯合研究中,與斯巴達珠單抗、Kisqali 和納扎替尼以及 Mirati 的 G12C 的多項聯合研究。
And we're working very hard to finalize some of those early results, which we hope can inform pivotal studies in the combination path going forward across a range of solid tumors.
我們正在非常努力地完成其中一些早期結果,我們希望這些結果可以為跨一系列實體瘤的聯合路徑中的關鍵研究提供信息。
So moving to Slide 12.
所以轉到幻燈片 12。
Just briefly on iptacopan in PNH.
簡單介紹一下 PNH 的 iptacopan。
This was data we recently presented.
這是我們最近提供的數據。
It demonstrates that we were able to significantly reduce residual hemolysis in eculizumab-treated patients and returning their hemoglobin to normal.
這表明我們能夠顯著減少接受依庫珠單抗治療的患者的殘餘溶血,並使他們的血紅蛋白恢復正常。
It's important to note there is a significant proportion of eculizumab-treated patients that don't reach goal, and we believe as an add-on therapy this is important medicine.
值得注意的是,有很大一部分接受依庫珠單抗治療的患者沒有達到目標,我們認為作為一種附加療法,這是一種重要的藥物。
But even more importantly, you can see in the black squares, patients that were able to move off of their eculizumab treatment and maintain their overall hemoglobin levels, which is the basis of us going forward as a monotherapy as well in this indication.
但更重要的是,您可以在黑色方塊中看到能夠擺脫依庫珠單抗治療並維持其整體血紅蛋白水平的患者,這也是我們在這一適應症中作為單一療法向前發展的基礎。
Moving to the next slide.
轉到下一張幻燈片。
Similarly, in C3G, we see a very strong result.
同樣,在 C3G 中,我們看到了非常強勁的結果。
This data was presented over the weekend, just recently.
該數據是在最近的周末發布的。
It demonstrates a significant reduction in proteinuria.
它表明蛋白尿顯著減少。
You can see a very impressive p-value as well as, importantly, a stabilization of renal function through -- as measured by eGFR.
您可以看到一個非常令人印象深刻的 p 值,重要的是,通過 eGFR 測量,腎功能穩定。
Again, a very clean, safe, tolerable profile.
同樣,一個非常乾淨、安全、可容忍的配置文件。
This medicine with this data was able to receive EU PRIME designation, I think the EU's highest designation with respect to these sorts of medicines.
這種具有這些數據的藥物能夠獲得歐盟 PRIME 指定,我認為歐盟對這類藥物的最高指定。
So very exciting data for LNP023.
LNP023 的數據非常令人興奮。
Now lastly moving to Slide 14.
現在終於移到幻燈片 14。
Over the course of the quarter, you saw us making important strides in ESG across all our operations.
在本季度的過程中,您看到我們在所有運營中的 ESG 方面取得了重要進展。
It is our absolute goal to be a leader in ESG across large companies and in the health care industry.
成為大型公司和醫療保健行業 ESG 的領導者是我們的絕對目標。
We adopted ambitious targets in terms of access to innovation, our global health programs, committing to full carbon neutrality, that's on top of already committing to full neutrality in our own operations by 2025.
我們在獲得創新、我們的全球健康計劃、承諾完全碳中和等方面製定了雄心勃勃的目標,此外,我們已經承諾到 2025 年在我們自己的運營中實現完全中和。
We track, we measure, we transparently publish our targets annually, which I really think is unique amongst companies in our sector.
我們跟踪、衡量、每年透明地發布我們的目標,我真的認為這在我們行業的公司中是獨一無二的。
We launched the first sustainability-linked bond and links to social targets, particularly access to medicine.
我們推出了第一個與可持續發展相關的債券,並與社會目標(尤其是獲得藥物)建立了聯繫。
The bond was oversubscribed.
債券被超額認購。
And we also received upgrades to ESG scores from a range of third-party rating agencies, now ranked the #1 by multiple agencies across the health care sector.
我們還收到了一系列第三方評級機構對 ESG 評分的升級,這些機構現在被醫療保健行業的多家機構評為第一。
So we have a lot of work to do.
所以我們有很多工作要做。
We're nowhere near where we want to be, but we continue to make important progress on this front.
我們離我們想要達到的目標還很遠,但我們繼續在這方面取得重要進展。
So with that, I'll hand it over to our Chief Financial Officer, Harry Kirsch.
因此,我將把它交給我們的首席財務官 Harry Kirsch。
Harry Kirsch - CFO
Harry Kirsch - CFO
Thank you, Vas.
謝謝你,瓦斯。
Good morning and good afternoon, everybody.
大家早上好,下午好。
So I'm now going to walk you through some of the financials for the third quarter and the 9 months as well as provide you with an update on our full year guidance.
因此,我現在將向您介紹第三季度和 9 個月的一些財務狀況,並為您提供我們全年指導的最新信息。
Now as always, my comments refer to the results of continuing operations and growth rates in constant currencies, unless otherwise noted.
現在與往常一樣,除非另有說明,否則我的評論指的是持續經營的結果和以固定貨幣計算的增長率。
So Slide 16 shows the summary of our performance for quarter 3 and the past 9 months.
因此,幻燈片 16 顯示了我們第三季度和過去 9 個月的業績摘要。
First, I would like to focus on the year-to-date results on the right-hand side.
首先,我想關注右側的年初至今結果。
The 9 months performance was strong, with sales growing 4%, driving core operating income and core EPS growth of 16%.
9 個月表現強勁,銷售額增長 4%,推動核心營業收入和核心每股收益增長 16%。
As you know, sales were mainly driven by Entresto, Zolgensma and Cosentyx in the 9 months as well as the rest of our growth portfolio.
如您所知,9 個月內的銷售額主要由 Entresto、Zolgensma 和 Cosentyx 以及我們其他增長組合推動。
And the core operating income growth at this significant level was driven by higher sales, improved gross margins from various productivity and cost-saving initiatives.
這一顯著水平的核心營業收入增長是由更高的銷售額、各種生產力和成本節約舉措帶來的毛利率提高所推動的。
Of course, COVID-related lower marketing and sales spending also contributed to core operating income growth.
當然,與新冠病毒相關的較低營銷和銷售支出也促進了核心營業收入的增長。
Free cash flow was $8.3 billion, but down 12% in U.S. dollars, mainly driven by legal settlement cash outs and lower divestment proceeds compared to the prior year.
自由現金流為 83 億美元,但以美元計算下降 12%,主要是受法律和解現金支出以及與去年相比剝離收益減少的推動。
With respect to quarter 3, net sales were in line with prior year due to the increased generic competition, particularly of Afinitor and Exjade as well as the impact of COVID-19, mainly on our ophthalmology portfolio, which we will discuss in more detail later.
關於第三季度,由於仿製藥競爭加劇,尤其是 Afinitor 和 Exjade 以及 COVID-19 的影響,主要是對我們的眼科產品組合的影響,淨銷售額與上一年持平,我們將在稍後更詳細地討論.
Despite this, we were able to deliver another quarter of double-digit increase in our core operating income, which grew 11%, driven by lower spending and improved gross margin.
儘管如此,由於支出減少和毛利率提高,我們的核心營業收入實現了又一個季度兩位數的增長,增長了 11%。
Overall, a strong year-to-date performance, especially given the challenging business environment that we are all in.
總體而言,年初至今的表現強勁,尤其是考慮到我們所處的商業環境充滿挑戰。
Now next, let's focus on our core margins on Slide 17, broken down both again by quarter and year-to-date.
接下來,讓我們關注幻燈片 17 的核心利潤率,按季度和年初至今再次細分。
For the year-to-date, on the right side, continuing operations core margin was 33.2%, growing 360 basis points with strong improvements in both divisions.
年初至今,右側的持續運營核心利潤率為 33.2%,增長了 360 個基點,兩個部門都有了顯著改善。
Innovative Medicines margin moved up to 36.3%, up 270 basis points and Sandoz margin grew 420 basis points to 25.4%.
創新藥物利潤率上升 270 個基點至 36.3%,山德士利潤率增長 420 個基點至 25.4%。
Innovative Medicines margin is likely to be around the 35% for the full year, reaching our mid-30s margin target a couple of years earlier than planned.
全年創新藥物利潤率可能在 35% 左右,比計劃提前幾年達到我們 30 年代中期的利潤率目標。
Of course, we had a contribution from COVID-related reduced spending, but a significant part of these margin gains were also a result of productivity and cost-saving initiatives that we have implemented.
當然,我們從與 COVID 相關的支出減少中得到了貢獻,但這些利潤增長的很大一部分也是我們實施的生產力和成本節約計劃的結果。
The quarter reflects a similar pattern with continuing operations margin at 33.2%, growing 320 basis points and Innovative Medicines margins at 35.8%.
本季度反映了類似的模式,持續經營利潤率為 33.2%,增長 320 個基點,創新藥物利潤率為 35.8%。
Clearly, we are also well on track to deliver on our Innovative Medicines margin target of the mid- to high-30s margin in the midterm.
顯然,我們也有望在中期實現我們的創新藥物利潤率目標,即中期至 30 多歲的利潤率。
Let's now turn to Slide #18.
現在讓我們轉到幻燈片#18。
We have updated the chart that we showed last quarter on the impact of COVID on our different categories.
我們更新了上個季度顯示的關於 COVID 對我們不同類別的影響的圖表。
As a reminder, the graph shows you Innovative Medicines' weekly sales evolution based on a rolling 4-week average, indexed to quarter 4 of last year.
提醒一下,該圖表顯示了創新藥物基於 4 週滾動平均值的每週銷售演變,索引到去年第 4 季度。
We have used the same classification categories as before to allow you to compare.
我們使用了與以前相同的分類類別,以便您進行比較。
Our recent launches and the detail of what we count in releases beyond which you can see at the bottom of the slide footnotes, continue to grow quite strongly.
我們最近的發布以及我們在發布中計算的內容的詳細信息,您可以在幻燈片腳註的底部看到,繼續強勁增長。
The growth drivers line appears to be flat during the quarter.
本季度增長驅動線似乎持平。
However, our growth drivers performed well.
然而,我們的增長動力表現良好。
The flatness of the curve on the [red] center is also a reflection of some seasonality.
[紅色] 中心曲線的平坦度也反映了一些季節性。
Now turning to Cosentyx.
現在轉向 Cosentyx。
The dermatology and to some extent rheumatology markets continue to see lower new patient starts as a result of COVID-19.
由於 COVID-19,皮膚病學和某種程度上的風濕病學市場繼續看到較低的新患者開始。
Cosentyx also was impacted by strength with growth rates declining during July and August.
Cosentyx 也受到實力的影響,7 月和 8 月的增長率下降。
However, there are clear signs of recovery in September.
然而,9 月份有明顯的複蘇跡象。
For ophthalmology, in order to understand the market dynamics, it is important to split the market for the back of the eye and the front of the eye.
對於眼科來說,為了了解市場動態,將眼後市場和眼前市場分開是很重要的。
Back of the eye clinic [markets] recovered much quicker due to the urgency of treatment.
由於治療的緊迫性,眼科診所 [市場] 恢復得更快。
Our key ophthalmology product at the back of the eye dominated by Lucentis and shown in the gray line began to see signs of recovery towards the end of that quarter.
我們在眼後部的主要眼科產品由 Lucentis 主導並顯示在灰線中,在該季度末開始出現復甦跡象。
The recovery has not been seen in other ophthalmology due to roughly an equal impact from COVID-19 disruptions and the expected generic impact on the U.S., primarily for Travatan and Ciprodex.
由於 COVID-19 中斷的影響大致相同,以及對美國的預期一般影響,主要是對 Travatan 和 Ciprodex 的影響,其他眼科領域尚未出現復甦。
Similarly, our Sandoz retail business continues to be impacted by COVID, as Vas mentioned, as well as the decline of U.S. oral solids, which we have decided to retain earlier this year.
同樣,正如 Vas 所提到的,我們的 Sandoz 零售業務繼續受到 COVID 的影響,以及我們今年早些時候決定保留的美國口服固體藥物的下降。
Overall, COVID-19 continued to negatively impact demand in quarter 3, particularly in dermatology and ophthalmology.
總體而言,COVID-19 在第三季度繼續對需求產生負面影響,尤其是在皮膚科和眼科領域。
However, we are pleased to see that our recent launches and growth drivers continue to do well.
然而,我們很高興看到我們最近的發布和增長動力繼續表現良好。
Now turning to our full year guidance on Slide 19.
現在轉向我們對幻燈片 19 的全年指導。
We continue to expect continuing operation sales to grow mid-single digits.
我們繼續預計持續經營銷售額將增長中個位數。
We are now upgrading core operating income guidance to grow low double-digit to mid-teens.
我們現在正在升級核心營業收入指引,以將兩位數的低位增長到十幾歲左右。
Within the divisions, we expect Innovative Medicines sales to grow mid-single digits, and we have lowered the Sandoz top line guidance to be broadly in line with prior year.
在各部門內,我們預計創新藥物銷售額將增長中個位數,我們已將山德士的頂線指導下調至與上一年大致一致。
This is due to the decline of U.S. oral solids, which we decide to retain, as mentioned earlier, early this year and the impact of COVID on our retail business.
這是由於美國口服固體藥物的下降,如前所述,我們決定在今年年初保留這種藥物,以及 COVID 對我們零售業務的影響。
The key assumption for this guidance is that we see a continuation of the return to normal prescribing dynamics in the fourth quarter.
該指導的關鍵假設是,我們看到第四季度繼續恢復正常的處方動態。
September and early October, patients data in the U.S. point in that direction.
9 月和 10 月初,美國的患者數據表明了這個方向。
Now I want to go into some of the meaning behind our guidance and the various pushes and pulls.
現在我想談談我們的指導和各種推動和拉動背後的一些含義。
On Slide 20, we show the actual and expected quarterly development and expectations for the full year.
在幻燈片 20 中,我們展示了實際和預期的季度發展以及全年的預期。
During the fourth quarter, we anticipate for sales, which you see on the left side, low to mid single-digit growth.
在第四季度,我們預計銷售額(您在左側看到)將出現中低個位數增長。
And then for core operating income, it's going to the right side, mid- to high single-digit growth.
然後對於核心營業收入,它將向右,中高個位數增長。
The core operating income growth is expected to be somewhat lower than year-to-date as we will see some higher investments, including those for the Kesimpta and Leqvio launch and prelaunch investments.
預計核心營業收入增長將略低於年初至今,因為我們將看到一些更高的投資,包括 Kesimpta 和 Leqvio 的發射和發射前投資。
Still, after delivering 16% core operating income year-to-date, this results in our upgraded full year guidance of low double-digit to mid-teens for core operating income.
儘管如此,在年初至今實現了 16% 的核心營業收入之後,這導致我們將核心營業收入的全年指引從低兩位數提高到十幾歲左右。
Of course, if there would be a resurgence of the COVID-19 impact on the health care systems and prescribing behavior in our major markets, there is a scenario of lower sales growth in quarter 4 versus what we assume here, which could also then reduce our full year sales growth to the 3% to 4% range as we have delivered 4% sales growth in the first 9 months.
當然,如果 COVID-19 對我們主要市場的醫療保健系統和處方行為的影響再次出現,第 4 季度的銷售增長可能會低於我們在此假設的情況,這也可能會減少由於我們在前 9 個月實現了 4% 的銷售額增長,我們全年的銷售額增長了 3% 到 4% 的範圍。
On core operating income, we would expect this quarter 4 and full year level even with potentially COVID-related lower sales growth in quarter 4 as we are kind of naturally hedged on the bottom line should lockdowns happen again due to the expected lower spend levels in such a scenario.
在核心營業收入方面,我們預計第四季度和全年的水平,即使第四季度可能與 COVID 相關的銷售增長下降,因為如果由於預期的支出水平下降而再次發生鎖定,我們自然會在底線上進行對沖這樣的場景。
Finally, on Slide 21.
最後,在幻燈片 21 上。
As currencies are constantly changing, I want to bring to your attention the estimated currency effects on our results using the current exchange rates.
由於貨幣在不斷變化,我想提請您注意使用當前匯率估算的貨幣對我們結果的影響。
So it's late October rates prevail for the remainder of 2020, the full year impact of currencies on sales would be a negative 1% point, and our core operating income would be negative 4% point.
因此,2020 年剩餘時間以 10 月下旬的利率為準,全年貨幣對銷售額的影響將為負 1%,我們的核心營業收入將為負 4%。
If the same rates prevail for 2021, the full year effect of currencies on sales for 2021 would be a positive 1% to 2% points.
如果 2021 年採用相同的匯率,那麼貨幣對 2021 年全年銷售額的影響將是 1% 到 2% 的正值。
And our core operating income between 0 to plus 1% point.
而我們的核心營業收入在0到正1個百分點之間。
And as a reminder, we do update these effects on our website on a monthly basis.
提醒一下,我們確實會每月在我們的網站上更新這些效果。
And with that, I hand over to Marie-France for an update on the pharma business.
有了這個,我向 Marie-France 提交了有關製藥業務的最新信息。
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Thank you, Harry.
謝謝你,哈利。
Good morning, good afternoon to all of you.
早上好,大家下午好。
So let's turn to the overall performance for Pharmaceuticals.
因此,讓我們轉向製藥業的整體表現。
The first 9 months saw sales grow 6% with continued momentum from our 2 key growth drivers.
前 9 個月的銷售額增長了 6%,我們的兩個關鍵增長驅動力持續強勁。
Q3 saw sales growth of 2% despite the continued COVID-19 impact.
儘管受到 COVID-19 的持續影響,第三季度的銷售額增長了 2%。
Our focus continues to be on driving Cosentyx and Entresto, also leveraging the launch of new indications and geographical expansion.
我們的重點仍然是推動 Cosentyx 和 Entresto,同時利用新適應症的推出和地域擴張。
And of course, executing on the launches of Beovu, Kesimpta and Leqvio.
當然,在 Beovu、Kesimpta 和 Leqvio 的發布上執行。
If we turn to Slide 23 -- 24.
如果我們轉到幻燈片 23 - 24。
For Cosentyx, Q3 brought us our first $1 billion quarter and 7% year-over-year growth, despite COVID-19 impact, intensifying competition, biosimilars and pricing pressure.
對於 Cosentyx 而言,第三季度為我們帶來了第一個 10 億美元的季度和 7% 的同比增長,儘管 COVID-19 產生了影響、競爭加劇、生物仿製藥和定價壓力。
This is a great testament to the complete profile of Cosentyx.
這很好地證明了 Cosentyx 的完整概況。
The market growth has slowed versus previous year due to COVID-19.
由於 COVID-19,市場增長與上一年相比有所放緩。
And today, we still see only an estimated 70% to 90% of patients returning versus the pre-COVID levels.
而今天,與 COVID 之前的水平相比,我們仍然看到估計只有 70% 到 90% 的患者返回。
We continue to see delays in diagnosis and slower new starts across the U.S. and the EU, particularly in dermatology.
我們繼續看到美國和歐盟的診斷延遲和新開工速度放緩,尤其是在皮膚病學領域。
Despite increasing competition, Cosentyx maintains a strong position in derm and is outperforming the market in rheum.
儘管競爭日益激烈,Cosentyx 在真皮中保持強勢地位,並且在大黃中的表現優於市場。
If we look at the U.S., we saw double-digit TRx growth year-over-year, strong momentum in the second half of this quarter.
如果我們看看美國,我們看到了兩位數的 TRx 同比增長,本季度下半年的強勁勢頭。
Our focus is on maintaining value in derm while driving the growth in rheum.
我們的重點是保持皮膚價值,同時推動大黃的增長。
If we look a little bit more closely at dermatology, we maintained our market share and our IL-17 leadership.
如果我們更仔細地研究皮膚病學,我們會保持我們的市場份額和 IL-17 的領先地位。
And in rheumatology, we're growing 3x the market year-over-year and leading in NBRx share around 30%.
在風濕病領域,我們的市場同比增長 3 倍,在 NBRx 市場份額領先約 30%。
If we turn to EU, Cosentyx has stabilized market share in derm and maintains rheumatology despite the increasing mandatory use of biosimilars in our key markets.
如果我們轉向歐盟,儘管在我們的主要市場越來越多地強制使用生物仿製藥,但 Cosentyx 已經穩定了真皮市場份額並維持了風濕病學。
There is significant opportunity for short- and long-term growth through increasing biologic penetration, something this year has suffered given COVID, and expanding our geographic footprint as well as our future indications.
通過提高生物滲透率(今年因 COVID 遭受了一些影響)以及擴大我們的地理足跡以及我們未來的適應症,存在著短期和長期增長的重要機會。
We aspire to maintain a strong position in the dermatology space, and we're set to accelerate in rheumatology.
我們渴望在皮膚病學領域保持強勢地位,我們將在風濕病學領域加速發展。
In Q4, we expect to return to double-digit growth, and we see a continued strong growth trajectory for Cosentyx in 2021 and beyond with a potential of $5 billion and beyond for the brand.
在第四季度,我們預計將恢復兩位數的增長,我們認為 Cosentyx 在 2021 年及以後將繼續保持強勁的增長軌跡,該品牌的潛力將達到 50 億美元及以上。
If I turn to Slide 25 and to Entresto, Q3 saw another excellent performance quarter driven by underlying strong demand across geographies.
如果我轉向幻燈片 25 和 Entresto,第三季度在跨地區潛在強勁需求的推動下又出現了一個出色的表現季度。
Entresto's great momentum is reinforced by how significant the unmet need is and how Entresto is increasingly used as an essential first choice treatment.
未滿足需求的重要性以及 Entresto 如何越來越多地被用作基本的首選治療方法,強化了 Entresto 的巨大勢頭。
The U.S. weekly NBRx has returned to above 4,000 by the end of Q3, despite the seasonality of the summer.
儘管夏季是季節性的,但到第三季度末,美國每週 NBRx 已恢復到 4,000 以上。
And we continue to see strong TRx growth versus previous year.
與去年相比,我們繼續看到強勁的 TRx 增長。
China continues strong growth as well, increasing penetration and account expansion.
中國也繼續強勁增長,增加滲透率和擴大賬戶。
I think we can say that Entresto is recognized as standard of care for treatment of HFrEF and delivers on its value proposition of keeping patients out of hospital.
我認為我們可以說 Entresto 被公認為 HFrEF 治療的護理標準,並提供了讓患者遠離醫院的價值主張。
This is, of course, especially important right now.
當然,現在這一點尤其重要。
We're confident in the future growth of Entresto.
我們對 Entresto 的未來增長充滿信心。
Please remember that about 3 out of 4 eligible HFrEF patients are still not on Entresto.
請記住,4 名符合條件的 HFrEF 患者中約有 3 名仍未使用 Entresto。
We're seeing expansion in China and Japan and potential new indications in the near future.
我們看到在中國和日本的擴張以及在不久的將來可能出現的新跡象。
If I turn to Slide 26, Beovu.
如果我轉到幻燈片 26,Beovu。
So what's new?
那麼有什麼新東西呢?
If we look at 3 post hoc analyses that have recently demonstrated the correlation between the role of fluid and wet AMD and vision outcomes.
如果我們看一下最近證明液體和濕 AMD 的作用與視力結果之間的相關性的 3 項事後分析。
These recent analyses are showing that more than 50% of the eyes treated with the current anti-VEGF therapies have residual retinal fluid after 2 years of treatment.
這些最近的分析表明,超過 50% 的接受當前抗 VEGF 療法治療的眼睛在治療 2 年後仍有殘留的視網膜液。
What we also see is that above 30% of patients at year 1 of follow-up are dosed more frequently than every 8 weeks.
我們還看到,在隨訪的第 1 年,超過 30% 的患者給藥頻率高於每 8 週一次。
There is a clear unmet need for medicines that provide greater fluid resolution, which is what Beovu offers.
對能夠提供更高液體分辨率的藥物存在明顯未滿足的需求,這正是 Beovu 提供的。
We have a full development program that's continuing, and we've recently released the results of KITE, our pivotal DME study, which met its endpoints and confirmed the importance of fluid reduction on vision outcomes.
我們有一個完整的開發計劃正在繼續,我們最近發布了我們關鍵的 DME 研究 KITE 的結果,該研究達到了終點,並證實了減少液體對視力結果的重要性。
We now have approval in more than 50 countries with an updated label.
我們現在在 50 多個國家/地區獲得了更新標籤的批准。
Ex U.S., we see steady uptake in Germany and Japan.
除美國外,我們看到德國和日本穩步增長。
We've seen U.S. demand recover and stabilize around 1,200 vials per week.
我們已經看到美國需求復蘇並穩定在每週 1,200 瓶左右。
We believe that the rare events can be managed, and we continue to educate HCPs about how to reduce risk as clinical practice impacts the effects of this medicine.
我們相信罕見事件是可以控制的,並且我們繼續教育 HCP 如何降低風險,因為臨床實踐會影響這種藥物的效果。
With Beovu's favorable benefit/risk profile, we believe we can achieve blockbuster status with this product.
憑藉 Beovu 有利的收益/風險狀況,我們相信我們可以通過該產品達到重磅炸彈的地位。
On Slide 27, if I turn to Kesimpta.
在幻燈片 27 上,如果我轉向 Kesimpta。
Kesimpta has the potential to become our first-choice high-efficacy DMT for patients, physicians and payers.
Kesimpta 有可能成為我們為患者、醫生和付款人提供的首選高效 DMT。
We're launching with an agile approach and focusing our efforts on HCP adoption, patient initiation and access.
我們正在以一種敏捷的方法啟動,並將我們的工作重點放在 HCP 的採用、患者啟動和訪問上。
For us, it's key to have broad HCP engagement and have this translate into adoption.
對我們來說,擁有廣泛的 HCP 參與並將其轉化為採用是關鍵。
Our field force has reached above 90% of our targets either through face-to-face or through adaptive digital initiatives.
通過面對面或自適應數字計劃,我們的現場部隊已達到 90% 以上的目標。
And we are now covering over 90% of our field force territories as our field force has returned to the field.
隨著我們的野戰部隊重返戰場,我們現在覆蓋了 90% 以上的野戰部隊領土。
We've delivered our first access wins in record time, and we're on track to obtain broad rapid access.
我們已經在創紀錄的時間內實現了我們的第一次訪問勝利,並且我們有望獲得廣泛的快速訪問。
Patients are experiencing seamless process in the patient and treatment initiation.
患者正在經歷患者和治療開始的無縫過程。
This is seen as simple, easy and fast by both patients and physicians.
患者和醫生都認為這是簡單、容易和快速的。
We're fully focused on execution.
我們完全專注於執行。
2020 is about driving demand to benefit as many MS patients as possible.
2020 年將推動需求,以使盡可能多的 MS 患者受益。
And we believe this will translate into solid sales growth in 2021.
我們相信這將轉化為 2021 年的穩健銷售增長。
If I turn to Leqvio on Slide 28.
如果我在幻燈片 28 上轉向 Leqvio。
It's a unique product, and it addresses both clinical and nonclinical barriers.
這是一種獨特的產品,它解決了臨床和非臨床障礙。
With Leqvio, we will be providing effective and sustained LDL-C reduction up to 52% with 2 doses a year.
使用 Leqvio,我們將每年服用 2 劑,有效且持續地將 LDL-C 降低多達 52%。
Our worldwide launches are progressing rapidly and underway, and we've just received CHMP opinion ahead of schedule for the treatment of primary hypercholesteremia and mixed dyslipidemia.
我們在全球範圍內的推出正在迅速推進中,我們剛剛提前收到了 CHMP 意見,用於治療原發性高膽固醇血症和混合性血脂異常。
The EU approval is expected in the January -- December-January time frame for all 27 member states and the U.K. And the FDA action date, as Vas mentioned, is expected in December 2020.
歐盟的批准預計將在 1 月 - 12 月至 1 月的時間範圍內對所有 27 個成員國和英國進行。正如 Vas 所提到的, FDA 的行動日期預計在 2020 年 12 月。
I wanted to spend just a moment and talk a little bit about the unmet need in this space.
我想花一點時間談談這個領域未滿足的需求。
It is extremely high for patients and health care systems.
對於患者和醫療保健系統來說,這是非常高的。
We see above 135 million ASCVD patients in the key markets, 18 million deaths a year.
我們在主要市場看到超過 1.35 億 ASCVD 患者,每年有 1800 萬人死亡。
80% of patients treated on statins are not at goal, and more than 50% of patients are not adhering to treatment.
80% 接受他汀類藥物治療的患者未達到目標,超過 50% 的患者未堅持治療。
ASCVD cost the health care systems over $1 trillion a year in health care spend.
ASCVD 每年使醫療保健系統花費超過 1 萬億美元的醫療保健支出。
This is not because they're not good treatments, but because the nonclinical barriers are high, either access, affordability or adherence, which we know will take time and a different approach to resolve.
這並不是因為它們不是很好的治療方法,而是因為非臨床障礙很高,無論是可及性、可負擔性還是依從性,我們知道這需要時間和不同的方法來解決。
But this product has a long patent life, and we're committed to differentiated approaches to make an impact on ASCVD.
但是這款產品的專利壽命很長,我們致力於通過差異化的方法對 ASCVD 產生影響。
With this unique profile and our innovative commercial model, we think we have a real chance of tackling ASCVD at a completely different scale.
憑藉這種獨特的形象和我們創新的商業模式,我們認為我們有真正的機會以完全不同的規模解決 ASCVD。
So in conclusion, we expect to deliver further growth in Q4 despite the continuing COVID-19 impacts.
因此,總而言之,儘管 COVID-19 的影響持續存在,我們預計第四季度將實現進一步增長。
With our relentless focus on our priorities and with our innovative approaches to deliver customer value, we are setting up ourselves for short- and long-term success.
憑藉我們對優先事項的不懈關注以及我們提供客戶價值的創新方法,我們正在為短期和長期的成功做好準備。
We're driving growth with Cosentyx and Entresto, leveraging new indications and geographical expansion, we're executing on the launch of Beovu, Kesimpta and Leqvio and we're preparing the market for our future blockbuster launches.
我們正在推動 Cosentyx 和 Entresto 的增長,利用新的適應症和地域擴張,我們正在執行 Beovu、Kesimpta 和 Leqvio 的推出,我們正在為我們未來的重磅產品推出市場做準備。
I want to thank the teams for their hard work in these trying times and hand it over to Susanne.
我要感謝團隊在這些艱難時期的辛勤工作,並將其交給 Susanne。
Susanne Schaffert - President of Novartis Oncology
Susanne Schaffert - President of Novartis Oncology
Thank you very much, Marie-France.
非常感謝你,瑪麗-法蘭西。
And let's turn to Slide 30.
讓我們轉到幻燈片 30。
The Oncology business remains resilient, delivering 4% of growth for the 9 months with sales reaching $10.9 billion.
腫瘤業務保持彈性,在 9 個月內實現了 4% 的增長,銷售額達到 109 億美元。
In the quarter, we have seen a very strong uptick of our recent launches, Kisqali, Kymriah, Piqray, Adakveo and the recently launched Tabrecta.
在本季度,我們看到了我們最近推出的 Kisqali、Kymriah、Piqray、Adakveo 和最近推出的 Tabrecta 的強勁增長。
And also our growth drivers, Promacta/Revolade, Tafinlar + Mekinist and Jakavi, continued very strong double-digit growth.
此外,我們的增長動力 Promacta/Revolade、Tafinlar + Mekinist 和 Jakavi 繼續保持兩位數的強勁增長。
The strong momentum across these brands was offset this quarter by increasing generic erosion of Afinitor, Exjade in the U.S. and Sandostatin LAR in Europe as well as continued COVID impact in some areas of the Oncology business.
這些品牌的強勁勢頭在本季度被 Afinitor 、美國的 Exjade 和歐洲的 Sandostatin LAR 的仿製藥侵蝕增加以及 COVID 在腫瘤學業務的某些領域的持續影響所抵消。
Due to the pandemic, our radioligand therapy, Lutathera, continued to experience increased number of cancellations and delays in new patient starts, still achieving sales of $109 million (sic) [$119 million].
由於大流行,我們的放射配體療法 Lutathera 繼續經歷越來越多的新患者開始取消和延遲,仍然實現了 1.09 億美元(原文如此)[1.19 億美元]的銷售額。
But overall, oncology business remains very resilient, and we are confident about the dynamic into the fourth quarter maintained by the strong performance of in-market brands and recent launches.
但總體而言,腫瘤業務仍然非常有彈性,我們對進入第四季度的動力充滿信心,這得益於市場內品牌的強勁表現和近期推出的產品。
Moving to Slide 31.
轉到幻燈片 31。
Kisqali continued its very strong growth trajectory with Q3 sales of $183 million and 50% growth from previous year, benefiting from the ongoing impact of positive overall survival data from 2 pivotal Phase III trials.
Kisqali 繼續其非常強勁的增長軌跡,第三季度銷售額為 1.83 億美元,比上年增長 50%,受益於 2 項關鍵 III 期試驗的積極總體生存數據的持續影響。
We have seen very strong uptake in market share gain ex U.S., especially in European markets where both post and premenopausal indications were approved for reimbursement in Germany, Italy, France and Spain, and also in the U.S., where Kisqali continued to grow and gain market share in Q3, and this despite patient screening being suppressed and approximately 20% decline in NBRx of CDK4/6.
我們看到美國以外的市場份額增長非常強勁,特別是在歐洲市場,德國、意大利、法國和西班牙批准了對絕經後和前適應症進行報銷,在美國,Kisqali 繼續增長並獲得市場第三季度的份額,儘管患者篩查受到抑制,CDK4/6 的 NBRx 下降約 20%。
And at the moment, Kisqali is the fastest-growing CDK4/6 in the U.S.
目前,Kisqali 是美國增長最快的 CDK4/6。
We are also pleased to see that differentiation within the CDK4/6 class is increasingly recognized.
我們也很高興地看到,CDK4/6 類別的差異性越來越得到認可。
And just to remind you that Kisqali has a unique profile versus other CDK4/6 inhibitors with preferential inhibition to CDK4 over CDK6 and a high concentration to inhibit the target.
並且只是提醒您,與其他 CDK4/6 抑製劑相比,Kisqali 具有獨特的特徵,優先抑制 CDK4 而不是 CDK6,並且抑制目標的濃度很高。
We are very proud to share with you that Kisqali has received the highest rating as the only CDK4/6 on the ESMO Magnitude of Clinical Benefit Scale, confirming once again the substantial benefit for patients based on significant overall survival benefit.
我們非常自豪地與您分享,Kisqali 獲得了 ESMO 臨床獲益量表上唯一的 CDK4/6 最高評級,再次證實了基於顯著總體生存獲益的患者的實質性獲益。
On the development side, we are expecting a readout with overall survival results from our MONALEESA-2 study in H2 '21.
在開發方面,我們期待在 H2 '21 中獲得 MONALEESA-2 研究的總體生存結果。
Our NATALEE trial, as Vas mentioned, in high and intermediate adjuvant breast cancer is enrolling well.
正如 Vas 所提到的,我們的 NATALEE 試驗在高和中度輔助乳腺癌中的招募情況良好。
We have extended the enrollment in the trial in order to enrich the data set generated with the increased sample size and allow more robust assessment of the treatment effect.
我們擴大了試驗的註冊範圍,以豐富隨著樣本量增加而產生的數據集,並允許對治療效果進行更穩健的評估。
The NATALEE trial is on track for final readout in 2020.
NATALEE 試驗有望在 2020 年進行最終讀數。
So overall, we are very pleased with the performance of Kisqali.
所以總的來說,我們對 Kisqali 的表現非常滿意。
And with that, I hand back to Vas.
有了這個,我交還給 Vas。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Susanne.
謝謝你,蘇珊。
So just in conclusion, as you can see, we had a very solid quarter with double-digit core operating income growth despite the impact of COVID on health care systems.
因此,總而言之,正如您所看到的,儘管 COVID 對醫療保健系統產生了影響,但我們的季度核心營業收入實現了兩位數的增長。
Our growth drivers, our launch brands, the key drivers for our mid- to long-term growth, are well intact and performing well.
我們的增長動力,我們的發布品牌,我們中長期增長的主要動力,完好無損且表現良好。
We raised our full year core operating income guidance, as Harry outlined.
正如哈利所概述的,我們提高了全年核心營業收入指引。
Our mid- and late-stage pipeline is advancing.
我們的中後期管道正在推進。
And I hope all of you will continue to appreciate the depth and breadth of our mid-stage pipeline in the coming months and years.
我希望你們所有人在未來幾個月和幾年內繼續欣賞我們中期管道的深度和廣度。
And lastly, we continue to progress on our journey to become an ESG leader with concrete advances over the quarter.
最後,我們繼續在成為 ESG 領導者的道路上取得進展,並在本季度取得具體進展。
We look forward to taking your questions.
我們期待著回答您的問題。
So operator, we can open the line.
所以接線員,我們可以開線了。
Operator
Operator
(Operator Instructions) Your first question today comes from the line of Mark Purcell from Morgan Stanley.
(操作員說明)您今天的第一個問題來自摩根士丹利的 Mark Purcell。
Mark Douglas Purcell - Equity Analyst
Mark Douglas Purcell - Equity Analyst
Mark Purcell, Morgan Stanley.
馬克·珀塞爾,摩根士丹利。
Just a couple for me.
對我來說只是一對。
In terms of Sandoz, I noted on the Meet the Management event, there's going to be a focus on this business.
就 Sandoz 而言,我在 Meet the Management 活動中指出,將重點關注這項業務。
So perhaps could you sort of talk to us about some of the pipeline opportunities you see here.
所以也許你能和我們談談你在這裡看到的一些管道機會。
And over to Harry, in terms of there's a significant opportunity on the global manufacturing footprint within this business, what sort of operating margin targets do you believe you can get?
至於哈利,就該業務的全球製造足跡而言,這是一個重要的機會,您認為您可以獲得什麼樣的營業利潤率目標?
And for the pipeline, I mean things like Gan & Lee and Biocon and denosumab, which you haven't spent much time talking about yet.
對於管道,我指的是 Gan & Lee 和 Biocon 和地諾單抗,你還沒有花太多時間談論它們。
And then a second one for Harry, on the group margin, 360 basis points improvement.
然後是哈利的第二個,在小組保證金上,提高了 360 個基點。
Could you help us understand the underlying improvement and the sort of COVID-related improvement and how sticky that COVID-related part might be going forward.
您能否幫助我們了解潛在的改進和與 COVID 相關的改進類型,以及與 COVID 相關的部分可能會有多大的粘性。
And the last question is on iscalimab.
最後一個問題是關於iscalimab。
So a little bit like LNP, it's, I guess, a pipeline and a product here.
所以有點像 LNP,我猜它是一個管道和一個產品。
Can you help us understand if there's going to be any more sort of interim analysis from the proof-of-concept data as that matures in the transplantation setting and sort of frame the opportunity in Sjögren's syndrome?
您能否幫助我們了解,隨著移植環境的成熟,是否會從概念驗證數據中進行更多類型的中期分析,並為 Sjögren 綜合徵提供機會?
I think it's the second most prevalent autoimmune disease.
我認為這是第二大流行的自身免疫性疾病。
So how significant could that opportunity be ahead of proof-of-concept data in the second half of this year?
那麼,這個機會在今年下半年的概念驗證數據之前會有多重要呢?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Mark.
謝謝你,馬克。
So first, Richard, on Sandoz's pipeline and global manufacturing.
首先,理查德,關於山德士的管道和全球製造。
Richard Saynor - CEO of Sandoz
Richard Saynor - CEO of Sandoz
Yes.
是的。
Thank you, Mark.
謝謝你,馬克。
Let's start with the pipeline.
讓我們從管道開始。
We don't generally disclose specific elements of our pipeline, but we have a very strong pipeline across small molecules, but increasingly biologics and more complex products to bring to market with the goal of ideally being at first entry in market at LOE formation, I guess, pretty much all our territories.
我們通常不披露我們管道的具體元素,但我們有一個非常強大的小分子管道,但越來越多的生物製劑和更複雜的產品推向市場,理想的目標是在 LOE 形成時首先進入市場,我猜猜,幾乎我們所有的領土。
You raised the point about supply.
你提出了關於供應的觀點。
Actually, first of all, yes, supply this year has been remarkably strong given the challenges that we've had.
實際上,首先,是的,鑑於我們面臨的挑戰,今年的供應非常強勁。
And also, we've gone ahead and formed Sandoz TechOps over this year.
此外,我們在今年繼續組建了 Sandoz TechOps。
That means that we have far more control oversight utilization, investment and strategy that is helping to bring better COG reduction and a greater degree of alignment between the retail and commercial businesses and the supply chain, which, as you know, in generics is a key success factor.
這意味著我們對監督使用、投資和戰略有更多的控制權,這有助於更好地降低 COG 並在零售和商業業務與供應鏈之間實現更大程度的協調,如您所知,這在仿製藥中是關鍵成功因素。
So thank you.
所以謝謝。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And maybe just to add one point, we have signed a range of deals over the recent years to continue to bolster the Sandoz portfolio, including the Aspen pharmaceuticals business in Japan, which helps us build out our injectables portfolio and pipeline in Japan; the Gan & Lee, as you mentioned, in diabetes; the Biocon collaboration.
也許只是為了補充一點,我們近年來簽署了一系列交易,以繼續支持山德士產品組合,包括日本的 Aspen 製藥業務,這有助於我們在日本建立我們的注射劑產品組合和管道;正如你所提到的,甘李治療糖尿病; Biocon 合作。
So our aspiration is both through the internal portfolio and biosimilars, but also with the range of partnerships to not only tackle the kind of largest opportunities in biosimilars, but also the mid -- so-called mid-tier opportunities in biosimilars and build a broad and deep portfolio.
因此,我們的願望既是通過內部投資組合和生物仿製藥,也是通過一系列合作夥伴關係來解決生物仿製藥的最大機會,以及生物仿製藥的中級機會——所謂的中端機會,並建立廣泛的合作夥伴關係。和深厚的投資組合。
I think, Mark, you also asked around margins.
我想,馬克,你也問過利潤。
We have an aspiration to get to the mid- to high-20s margins in Sandoz over time.
隨著時間的推移,我們渴望在 Sandoz 達到 20 多歲的中高利潤率。
This won't be necessarily overnight, and we believe that we have the potential to be in line with the top-tier peers in the generic sector, and that's absolutely our goal.
這不一定會在一夜之間發生,我們相信我們有潛力與仿製藥領域的頂級同行保持一致,這絕對是我們的目標。
Harry, on group margins?
哈利,在小組邊緣?
Harry Kirsch - CFO
Harry Kirsch - CFO
Yes.
是的。
First, also on Sandoz, I mean we are in the mid-20s, clearly the mid- to high 20s we see as achievable.
首先,同樣在 Sandoz 上,我的意思是我們處於 20 多歲,顯然是我們認為可以實現的 20 多歲。
And Mark correct, of course, the manufacturing initiatives, transformation initiatives are also in a significant way supporting the Sandoz margin.
當然,馬克正確,製造計劃、轉型計劃也在很大程度上支持山德士的利潤。
In addition to, of course, will be the biologic success given that structurally biologics and biosimilars have a higher-margin structure than the other part of the business.
當然,此外,鑑於結構生物製劑和生物仿製藥具有比業務的其他部分更高的利潤率結構,生物製劑的成功也將是其中的一部分。
So very good potential year for the Sandoz business.
山德士業務非常有潛力的一年。
But of course, overall for the Group and Innovative Medicines, also very positive.
但當然,總體而言,對於集團和創新藥物來說,也非常積極。
If you look at the first 9 months, 360 basis points of improvement.
如果您查看前 9 個月,改善了 360 個基點。
And I think we can almost put it 1/3, 1/3, 1/3.
我認為我們幾乎可以把它放在 1/3、1/3、1/3 上。
1/3 is driven by the gross margin.
1/3是由毛利率驅動的。
Also here, of course, the manufacturing footprint and some mix effects has a positive impact, about 1/3 of that 360-odd percent -- 360 basis points.
當然,在這裡,製造足跡和一些混合效應也會產生積極影響,大約是 360% 的 1/3——360 個基點。
And the other -- another 1/3, I would say, will be COVID-related lower spend levels in the line of productivity and sales, 4% sales growth, maybe fixed cost pick-up.
而另一個——我想說,另外 1/3 將是與 COVID 相關的生產力和銷售方面的較低支出水平,4% 的銷售增長,可能是固定成本回升。
Now we do expect that some of the COVID-related underspend will come back.
現在我們確實希望一些與 COVID 相關的支出不足會回來。
And by the way, also in the current situation, we do invest into our products where it's possible.
順便說一句,在目前的情況下,我們確實在可能的情況下投資於我們的產品。
Of course, we don't waste money, and some activities are simply not possible or possible only at a lower level.
當然,我們不浪費錢,有些活動根本不可能或只能在較低的水平上進行。
But we do also believe that most of the productivity that we find in this new situation will also stick for the future.
但我們也相信,我們在這種新情況下發現的大部分生產力也將持續到未來。
And that's, of course, a key element that we work ourselves next year and the 3- to 5-year plan.
當然,這也是我們明年和 3 到 5 年計劃的關鍵要素。
So we expect that with this we do increase our core margin on the Innovative Medicines business and the company each of next years, and that we are very well on track to get to the mid- to high 30s with this margin improvements year-by-year as we continue on our -- on productivity programs and also figure out how we make most of the COVID-related productivity initiatives also stick.
因此,我們預計,通過這一點,我們確實會增加我們在創新藥物業務和公司每年的核心利潤率,並且隨著利潤率的逐年提高,我們有望進入 30 年代中期至高位。一年,我們繼續我們的生產力計劃,並弄清楚我們如何使大多數與 COVID 相關的生產力計劃也堅持下去。
So overall, on a very good trajectory there.
所以總的來說,那裡的軌跡非常好。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Harry.
謝謝,哈利。
And then John, on iscalimab.
然後是約翰,在 iscalimab 上。
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes.
是的。
Yes.
是的。
As you know, Mark, our iscalimab is our anti-CD40 that we're advancing in multiple indications.
如你所知,馬克,我們的 iscalimab 是我們在多個適應症中推進的抗 CD40。
Our primary indication that we're pursuing is in renal transplant, and we've shared some of the data previously.
我們追求的主要適應症是腎移植,我們之前已經分享了一些數據。
And we're moving forward with an innovative approach that we call iBox, which is a risk prediction scoring that combines measurements of the kidney function, and we look forward to bring that to the market, working with the health authorities in the early '23 time frame.
我們正在推進一種我們稱之為 iBox 的創新方法,這是一種結合了腎功能測量的風險預測評分,我們期待在 23 年初與衛生當局合作將其推向市場大體時間。
That's for renal transplant.
那是腎移植。
You were referring to the Sjögren's syndrome, which is an additional indication that we're exploring.
您指的是乾燥綜合徵,這是我們正在探索的另一個跡象。
And that is moving forward currently in a Phase IIa study.
目前正在進行 IIa 期研究。
There is an interim reading out in the Sjögren's syndrome population.
在乾燥綜合徵人群中有一個臨時讀數。
That will not come out until the first half of 2022.
這要到 2022 年上半年才會出現。
So those are the general time lines, but we are looking at multiple indications for iscalimab and we're hoping for potential multiple approaches to treating patients.
所以這些是一般的時間線,但我們正在研究 iscalimab 的多種適應症,我們希望有潛在的多種方法來治療患者。
Back to you, Vas.
回到你身邊,瓦斯。
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
So firstly, on the margin guidance that Harry was just touching on there.
所以首先,關於Harry 剛剛提到的邊際指導。
So year-to-date, you're almost into your mid- to high 30s margin target, which I think you've previously pitched as being by 2022.
因此,年初至今,您幾乎達到了 30 多歲的中高利潤率目標,我認為您之前已經將其定為到 2022 年。
So can you just help us understand when does margin -- where does margin growth stop?
那麼,您能否幫助我們了解保證金何時停止 - 保證金增長在哪裡停止?
So where is it capped at above that level?
那麼它在哪裡被限制在這個水平之上呢?
Secondly, on Kesimpta, were there any actual sales in the quarter?
其次,在 Kesimpta 上,本季度是否有任何實際銷售額?
Was it all free drug?
都是免費的藥嗎?
And how long do you expect the 2-month free drug program to continue?
您預計為期 2 個月的免費藥物計劃會持續多久?
Is that scheduled for all of Q1 or first half of 2021, for example?
例如,這是否計劃在整個第一季度或 2021 年上半年進行?
And then thirdly, on the changes on the NATALEE trial.
第三,關於 NATALEE 試驗的變化。
So you've highlighted you've increased to 5,000 patients.
所以你強調你已經增加到 5,000 名患者。
But have you changed recruitment criteria there at all to enrich the population for high-risk patients or amended the statistical analysis plan to allow a primary endpoint readout only in high-risk patients, for example?
但是,您是否完全改變了招募標準以豐富高危患者的人群,或者修改了統計分析計劃以允許僅在高危患者中讀取主要終點?
Or do you think that the differences we're seeing between the Ibrance and Verzenio adjuvant trials were actually product rather than trial population-related?
還是您認為我們在 Ibrance 和 Verzenio 輔助試驗之間看到的差異實際上是產品而不是試驗人群相關?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Graham.
謝謝,格雷厄姆。
On the mid- to longer-term margin, Harry?
中長期利潤,哈利?
Harry Kirsch - CFO
Harry Kirsch - CFO
Yes.
是的。
Thank you, Graham.
謝謝你,格雷厄姆。
Of course, we have to first recognize the first 9 months margin in our business is usually a bit above the full year as quarter 4 margins tend to be, for seasonality reasons, lower.
當然,我們必須首先認識到我們業務的前 9 個月利潤率通常略高於全年,因為由於季節性原因,第 4 季度的利潤率往往較低。
So we are in the first 9 months of 36.
所以我們處於 36 歲的前 9 個月。
I indicated for the full year, we see roughly 35 for Innovative Medicines.
我指出全年,我們看到大約 35 個創新藥物。
So we have some room to grow for the mid- to high 30s.
因此,對於 30 多歲的中高端,我們還有一些成長空間。
And then we don't put a cap on it.
然後我們不設上限。
But first, you want to get into a range of mid- to high 30s.
但首先,你想進入 30 多歲的中高年齡段。
I think most of large comparable market cap companies, R&D is mid- to high 30s.
我認為大多數大型可比市值公司的研發都在 30 歲左右。
But it depends also, of course, on the mix of businesses and the launch cycles.
但這當然也取決於業務組合和發布週期。
So I don't want to put a cap on it at the moment, but first, you want to get to the mid- to high 30s.
所以我現在不想給它設置上限,但首先,你想達到 30 多歲的中高水平。
And we always, always want to ensure that we have the right investment levels at the same time as we drive the productivity and the resource allocation.
我們總是,總是希望確保我們在提高生產力和資源分配的同時擁有正確的投資水平。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Harry.
謝謝,哈利。
On Kesimpta, Marie-France?
在 Kesimpta,Marie-France?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Yes.
是的。
So our focus in 2020 is really just about driving appropriate demand and initiation of patients.
因此,我們在 2020 年的重點實際上只是推動適當的需求和患者的啟動。
In other words, for us, the broad HCP adoption and ease of access and initiation is key.
換句話說,對我們來說,HCP 的廣泛採用以及易於訪問和啟動是關鍵。
As you know, we have this free drug program, and this will be a significant bridge for a number of patients until we get to paid scripts.
如您所知,我們有這個免費的藥物計劃,在我們獲得付費腳本之前,這將是許多患者的重要橋樑。
So far, our key metrics is going to be NBRx.
到目前為止,我們的關鍵指標將是 NBRx。
We're not underestimating the extra lift it takes to launch a product during this pandemic, and that's why we're really focused on driving demand and initiation.
我們並沒有低估在這種大流行期間推出產品所需的額外提升,這就是我們真正專注於推動需求和啟動的原因。
We've already seen some early access wins, and we're focusing on broad availability for patients.
我們已經看到了一些早期訪問的勝利,我們專注於為患者提供廣泛的可用性。
We've seen that with CVS and Aetna.
我們已經在 CVS 和 Aetna 上看到了這一點。
We've had our first Medicare win, and we want to ensure that patients have preferred single step access.
我們已經取得了第一次醫療保險的勝利,我們希望確保患者有首選的單步訪問權。
We believe that Kesimpta has a potential of being the first-choice DMT for patients, physicians and payers because it's highly efficacious, it's safe and it can be administered at home.
我們相信 Kesimpta 有可能成為患者、醫生和付款人的首選 DMT,因為它非常有效、安全並且可以在家中使用。
So that's what we're doing right now in 2020 is really focusing on the demand and initiation of patients.
所以這就是我們現在在 2020 年所做的,真正關注患者的需求和啟動。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Marie-France.
謝謝,瑪麗-法蘭西。
And John, on NATALEE?
和約翰,關於納塔利?
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes.
是的。
Thanks, Graham.
謝謝,格雷厄姆。
Thanks for the question on NATALEE.
感謝關於 NATALEE 的問題。
As you know, we increased the sample size from 4,000 to 5,000 patients to allow for more robust assessment of the overall treatment effect.
如您所知,我們將樣本量從 4,000 名患者增加到 5,000 名患者,以便對整體治療效果進行更穩健的評估。
What I will say is, for competitive reasons, we don't want to disclose too much details.
我要說的是,出於競爭原因,我們不想透露太多細節。
But we do believe in the unique Kisqali profile and the overall trial design remains the same.
但我們確實相信獨特的 Kisqali 配置文件,並且整體試驗設計保持不變。
So what we can disclose is that the enrollment is continuing and going very well.
所以我們可以透露的是,招生仍在繼續,進展順利。
We also are using a 400-milligram dose here.
我們在這裡也使用了 400 毫克的劑量。
And what we've seen so far is that this has been well tolerated, which is different from the 600-milligram dose in the advanced breast cancer patients.
到目前為止,我們所看到的是,它的耐受性很好,這與晚期乳腺癌患者的 600 毫克劑量不同。
So overall, it's going well, and recruitment is going very well.
所以總的來說,進展順利,招聘進展順利。
So thanks.
那謝謝啦。
Vas, back to you.
瓦斯,回到你身邊。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And maybe just to build on John's point, I mean, we believe that Kisqali is unique and it's focused, as I mentioned in my earlier comments, on CDK4.
也許只是為了建立約翰的觀點,我的意思是,我們相信 Kisqali 是獨一無二的,正如我在之前的評論中提到的,它專注於 CDK4。
We also believe with a robust trial in which we limit patient discontinuation -- discontinuations in the study, which we think hampered some of the other studies.
我們還相信,通過一項強有力的試驗,我們限制了患者的停藥——研究中的停藥,我們認為這阻礙了其他一些研究。
We have the opportunity to have the broadest indication in the entire competitive set, which would be, of course, a unique selling proposition for Kisqali around the world.
我們有機會在整個競爭組合中獲得最廣泛的指示,這當然是 Kisqali 在全球範圍內的獨特銷售主張。
So we're quite excited about taking this forward.
因此,我們對推動這一進程感到非常興奮。
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
Three questions for Marie-France, please, on inclisiran.
請在 inclisiran 上向 Marie-France 提出三個問題。
Firstly, in terms of the launch and marketing, should I assume that the Entresto field force is going to do the bulk of the heavy lifting?
首先,在發布和營銷方面,我是否應該假設 Entresto 現場力量將承擔大部分繁重工作?
Second, when would you expect a J code to be issued?
其次,您希望何時發布 J 代碼?
I understand they're issued quarterly now.
我知道它們現在每季度發布一次。
So I'm assuming either first or second quarter.
所以我假設第一季度或第二季度。
And then finally, just thinking about the degree of cost advantages you have in terms of pricing to payers versus the PCSK9 antibody.
最後,考慮一下您在向付款人定價方面與 PCSK9 抗體相比的成本優勢程度。
Could you just compare and contrast the COGS on inclisiran versus a monoclonal?
你能比較一下 inclisiran 和單克隆的 COGS 嗎?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks.
謝謝。
Marie-France, if you want to take the first so I can tackle the COGS.
Marie-France,如果你想拿第一個,我可以解決 COGS。
So on the field force and the J code, Marie-France.
所以關於場力和 J 代碼,Marie-France。
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Yes.
是的。
So I mean, clearly, there are a lot of synergies between the field force that we've built with Entresto and what we would like to do with inclisiran.
所以我的意思是,很明顯,我們用 Entresto 建立的現場力量與我們想用 inclisiran 做的事情之間有很多協同作用。
I think the approach that we're taking with inclisiran will require us to also build our capabilities in managing different stakeholders such as government and insurance companies and payers and working with systems.
我認為我們對 inclisiran 採取的方法將要求我們還建立管理不同利益相關者(例如政府和保險公司以及付款人)以及使用系統的能力。
So we will have to build additional capabilities.
所以我們將不得不建立額外的能力。
But overall, I think it's clear that when you look at Entresto, when you look at inclisiran and when you look into the future of our CM -- CDM portfolio, that there are a lot of synergies that we can leverage across the board.
但總的來說,我認為很明顯,當您查看 Entresto 時,當您查看 inclisiran 以及當您展望我們的 CM - CDM 產品組合的未來時,我們可以全面利用很多協同效應。
When it comes to the J code, yes, you're right, they are giving out J codes quarterly.
說到 J 代碼,是的,你是對的,他們每季度都會發布 J 代碼。
I think -- just to remind you that the lot of cardiologists in this space are not necessarily set up for the buy-and-bill process.
我認為 - 只是提醒您,這個領域的許多心髒病專家不一定是為購買和賬單流程而設置的。
But systems of care are and many of these cardiologists are affiliated with systems of care.
但是護理系統是,並且這些心髒病專家中的許多人都隸屬於護理系統。
So we believe that through the system we will be able to overcome this initial hurdle.
所以我們相信,通過這個系統,我們將能夠克服這個最初的障礙。
That being said, we will be building the capabilities for buy-and-bill possibilities for our cardiologists and beyond.
話雖如此,我們將為我們的心髒病專家及其他人員建立購買和賬單可能性的能力。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Marie-France.
謝謝,瑪麗-法蘭西。
And then on our longer-term strategy and how it links to the cost of goods.
然後是我們的長期戰略以及它如何與商品成本聯繫起來。
We, of course, have the aspiration to take the product broad into the ASCVD, secondary prevention market.
當然,我們希望將該產品廣泛用於 ASCVD 二級預防市場。
We have the ongoing secondary outcome study.
我們正在進行次要結果研究。
And then we also have the aspiration to test the medicine in primary prevention, an agreement with the NHS to take that forward and potentially additional supportive studies to get us to a primary prevention, which would open up the patient population quite dramatically.
然後,我們還希望在初級預防中測試該藥物,與 NHS 達成協議以推進這一進程,並可能進行額外的支持性研究,以使我們進行初級預防,這將極大地開放患者群體。
In order to enable that, we, of course, will then have to, over time, be able to provide this in larger volumes and at competitive cost.
為了實現這一點,我們當然必須隨著時間的推移能夠以具有競爭力的成本提供更大數量的產品。
We believe that as an RNA-based therapy with a small molecule production profile, we have the opportunity to drive these COGS quite low.
我們相信,作為一種基於 RNA 的具有小分子生產特性的療法,我們有機會將這些 COGS 降低到相當低的水平。
It's not as low perhaps as a traditional small molecule, but in that range.
它可能不像傳統的小分子那麼低,但在那個範圍內。
The way we're going to do that is we are, over time, planning to build up our own internal capabilities to produce this medicine.
我們要做到這一點的方式是,隨著時間的推移,我們計劃建立自己的內部能力來生產這種藥物。
We're working with collaborative group also in the U.K. to look at next-gen technologies.
我們也在與英國的協作小組合作,研究下一代技術。
But the aspiration would be certainly to have the cost be a fraction of the cost of a typical monoclonal antibody, and that would enable, I think, that large volume possibility.
但我們的願望肯定是讓成本成為典型單克隆抗體成本的一小部分,我認為這將實現大批量生產的可能性。
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
Firstly, on Kesimpta.
首先,關於凱辛普塔。
You've been clear about your plans to drive some demand in the short term.
你已經很清楚你在短期內推動一些需求的計劃。
But could you outline for us what you think the ramp towards profitability look quite for this drug?
但是您能否為我們概述一下您認為這種藥物的盈利能力如何?
Is it quicker than usual because you've made ofatumumab historically, albeit in a different formulation?
它是否比平時更快,因為您在歷史上製造過ofatumumab,儘管配方不同?
Then secondly, for John, on the factor B and C3G.
其次,對於約翰來說,關於因素 B 和 C3G。
A view from the regulator on what the appropriate endpoint is for a Phase III trial.
監管機構對 III 期試驗的適當終點的看法。
Is proteinuria enough?
蛋白尿夠嗎?
Or will you need eGFR?
還是您需要 eGFR?
And then maybe finally, on Zolgensma sales outside the U.S., I think you said Germany is playing a very substantial part.
然後也許最後,關於 Zolgensma 在美國以外的銷售,我想你說德國扮演了非常重要的角色。
But could you tell us what other countries are contributing meaningfully to revenue at this point?
但是,您能否告訴我們目前哪些其他國家/地區對收入做出了有意義的貢獻?
Is it just Japan?
只是日本嗎?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Laura.
謝謝你,勞拉。
So we'll start with the Kesimpta one.
所以我們將從 Kesimpta 開始。
Marie-France?
瑪麗-法蘭西?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Yes.
是的。
So I think we have to think about what Kesimpta is, right?
所以我認為我們必須考慮一下 Kesimpta 是什麼,對吧?
So Kesimpta is a high-efficacy therapy, it's well tolerated, it can be administered at home.
所以 Kesimpta 是一種高效療法,耐受性好,可以在家中使用。
And for this reason, we firmly believe that our position goes beyond the current B-cell market.
出於這個原因,我們堅信我們的地位超越了當前的 B 細胞市場。
If you think about the fact that 70% of patients are currently on either subcu or oral DMP and 63% of patients remain on low-efficacy therapies.
如果您考慮一下這樣一個事實,即 70% 的患者目前正在使用 subcu 或口服 DMP,而 63% 的患者仍在使用低效療法。
When you look at what's happening in the marketplace today, it's very encouraging to see the shift to higher-efficacy therapies.
當您查看當今市場上正在發生的事情時,看到向更高功效療法的轉變是非常令人鼓舞的。
We know that there are a number of physicians that are not necessarily -- don't necessarily have access to infusion capabilities or patients certainly in this COVID period who are going to be looking for options that don't require them to spend time in an IV infusion center.
我們知道有許多醫生不一定 - 不一定有輸液能力,或者在這個 COVID 時期肯定有患者將尋找不需要他們花時間在IV輸液中心。
So we believe that the way we should be positioning Kesimpta is in a first line or a first switch.
所以我們認為我們應該定位 Kesimpta 的方式是在第一線或第一個開關。
And that's why the focus for 2020 is really on the appropriate demand, the initiation of patients.
這就是為什麼 2020 年的重點確實是適當的需求,即患者的啟動。
If you look at some of the estimates on what the B-cell market could look like over the next 10 years, there are some estimates that point us to 35% to 40% of the market.
如果你看一些關於 B 細胞市場在未來 10 年會是什麼樣子的估計,有一些估計表明我們將佔據 35% 到 40% 的市場。
We certainly want to be participating in that very strongly.
我們當然希望非常強烈地參與其中。
So what the focus is now is broad adoption, ease of access initiation.
因此,現在的重點是廣泛採用,易於訪問啟動。
We've learned a lot from our previous launches in this space, and we know that it's absolutely crucial for us to have strong access and for patients to be able to initiate this drug very easily.
我們從之前在該領域的發布中學到了很多,我們知道擁有強大的訪問權限以及讓患者能夠非常輕鬆地啟動這種藥物對我們來說絕對至關重要。
We've got, as we said, the free drug program.
正如我們所說,我們有免費藥物計劃。
And our key metrics over the next couple of months is going to be NBRx.
我們未來幾個月的關鍵指標將是 NBRx。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Marie-France.
謝謝,瑪麗-法蘭西。
And then John, on the LNP -- C3G, LNP and Phase III endpoints?
然後約翰,關於 LNP——C3G、LNP 和 III 期端點?
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes.
是的。
For LNP, Laura, I guess, we'll call it, iptacopan, if you guys know the new name for it.
對於 LNP,Laura,我想,如果你們知道它的新名稱,我們會稱它為 iptacopan。
In fact, as we look at C3G, as you know, that there's no therapeutic agent designed to really target the underlying disease, which is complement dysfunction here.
事實上,正如你所知,當我們研究 C3G 時,沒有專門針對潛在疾病的治療劑,即補體功能障礙。
So we're really encouraged.
所以我們真的很受鼓舞。
And you saw the results that Vas shared in the presentation slide.
你看到了 Vas 在演示幻燈片中分享的結果。
So we're really encouraged by those results.
所以我們對這些結果感到非常鼓舞。
Now as you pointed out, in terms of proteinuria reduction, this is not a validated surrogate marker with the FDA.
現在正如您所指出的,就減少蛋白尿而言,這不是 FDA 驗證的替代標誌物。
So we're currently working with the FDA, looking at both the urine protein/creatinine ratio as well as looking at each estimated glomerular filtration rate, eGFR.
因此,我們目前正在與 FDA 合作,研究尿蛋白/肌酐比率以及每個估計的腎小球濾過率 eGFR。
And what we did see in the Phase II studies was that there was benefit in both.
我們在 II 期研究中看到的是兩者都有好處。
So as we move forward, we're capturing both in our studies and looking for the best path forward with the regulatory authorities.
因此,隨著我們向前邁進,我們在研究中捕捉並與監管機構一起尋找最佳的前進道路。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And then lastly, on Zolgensma ex U.S., there's -- I would say, maybe 4 groups of countries that are relevant.
最後,在 Zolgensma ex U.S. 上,我會說,可能有 4 組相關的國家。
The U.S., of course, Japan, as we continue to launch.
美國,當然還有日本,我們繼續推出。
In Europe, you have some early adopter countries, so primarily Germany and a few other smaller countries.
在歐洲,有一些早期採用者國家,主要是德國和其他一些較小的國家。
But then we're now working very hard on expanding access in the U.K., France, Spain and Italy.
但我們現在正在努力擴大在英國、法國、西班牙和意大利的訪問權限。
And then the fourth group will be the emerging market countries, which are substantial markets, countries like Turkey, Saudi Arabia and the Gulf Coast countries, Brazil, Australia, not emerging markets, but Australia and Canada. .
然後第四組是新興市場國家,它們是實質性市場,像土耳其、沙特阿拉伯和墨西哥灣沿岸國家,巴西、澳大利亞,不是新興市場,而是澳大利亞和加拿大。 .
So as the next 12 months unfold, various markets will come online at different points in time, depending on how fast the body -- the various access bodies move in providing reimbursement.
因此,隨著未來 12 個月的展開,不同的市場將在不同的時間點上線,具體取決於機構的速度——各種接入機構提供報銷。
We do continue to see a reasonable number of patients in self-pay situations as well and also compassionate use, of course, through our compassionate use program.
我們確實繼續看到合理數量的患者在自費情況下以及同情使用,當然,通過我們的同情使用計劃。
I'd say, overall, the demand is very robust across these markets, both below 2 years of age, but as I noted also a significant number of patients -- proportion of patients above 2 years of age as well.
我想說,總體而言,這些市場的需求都非常強勁,無論是在 2 歲以下,但正如我注意到的那樣,還有大量患者——2 歲以上的患者比例也是如此。
Operator
Operator
The next question comes from the line of Kerry Holford from Berenberg.
下一個問題來自 Berenberg 的 Kerry Holford。
Kerry Ann Holford - Analyst
Kerry Ann Holford - Analyst
Three questions, please.
請教三個問題。
Firstly, in multiple sclerosis, looking at Gilenya, how much of the sales declined in Q3 just due to pandemic disruption versus the increased competition you mentioned?
首先,在多發性硬化症中,看看 Gilenya,與您提到的競爭加劇相比,第三季度的銷售額下降了多少?
I ask which competitor you're losing share to?
我問你正在失去哪個競爭對手的份額?
I wonder if this is also a reflection of you promoting Mayzent and [convert] over to Gilenya and I presume that will continue going forward.
我想知道這是否也是您推廣 Mayzent 並 [convert] 到 Gilenya 的反映,我認為這將繼續前進。
ACZ, can I ask is there another interim analysis scheduled for the CANOPY-1 study before the final readout?
ACZ,我能問一下在最終讀數之前是否為 CANOPY-1 研究安排了另一項中期分析?
And if so, when that might be?
如果是這樣,那可能是什麼時候?
And then on Lutathera, I guess I'd like to understand what the risk is here.
然後在 Lutathera 上,我想我想了解這裡的風險。
The disruption we've seen currently due to the pandemic results in a permanent loss of access or interest for the physicians and for new patients.
我們目前看到的大流行造成的破壞導致醫生和新患者永久失去訪問或興趣。
How can you retain that interest in that relationship?
你怎麼能保持對這種關係的興趣?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Kerry.
謝謝你,克里。
So first, on Gilenya, Marie-France?
那麼首先,關於 Gilenya,Marie-France?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Yes.
是的。
So our Q3 Gilenya decline is as expected, and it's been driven by some inventory decreases, which should bounce back.
因此,我們第三季度 Gilenya 的下降符合預期,並且是由一些庫存減少推動的,這應該會反彈。
We have seen, as you know, a significant slowdown in the NBRx, especially in the S1P class.
如您所知,我們已經看到 NBRx 的顯著放緩,尤其是在 S1P 類中。
And Gilenya due to its pretesting and first-dose observation has seen a slowdown in the NBRx market.
Gilenya 由於其預測試和首次劑量觀察,NBRx 市場出現放緩。
We've also seen a slower recovery in the S1P market versus the others during this COVID pandemic.
在這次 COVID 大流行期間,我們還看到 S1P 市場與其他市場相比復甦較慢。
We have had a lot lower demand due to increased competition.
由於競爭加劇,我們的需求下降了很多。
There are new oral DMTs.
有新的口服 DMT。
And also, we have seen some switches happening with other competitors, higher RDs.
而且,我們已經看到其他競爭對手發生了一些轉變,更高的 RD。
And the fact that the full organizational focus is on driving new patient starts for Kesimpta and Mayzent.
事實上,整個組織的重點是推動 Kesimpta 和 Mayzent 的新患者開始。
So Gilenya continues to be a third-most prescribed DMT worldwide.
因此,Gilenya 仍然是全球第三大處方 DMT。
We know it's a high-efficacy oral.
我們知道這是一種高效的口服液。
It's the only DMT prescribed in pediatric patients 10 years or older.
它是唯一為 10 歲或以上的兒科患者開具的 DMT。
In the U.S., we'll continue to promote it in this population for patients who prefer orals, but our focus has clearly shifted.
在美國,我們將繼續在這一人群中為喜歡口服的患者推廣它,但我們的重點顯然已經轉移。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Marie-France.
謝謝,瑪麗-法蘭西。
On canakinumab, John?
在 canakinumab 上,約翰?
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes.
是的。
For canakinumab in the first-line non-small cell lung cancer study, Kerry, what Vas did mention earlier in the presentation is that the DMC did meet earlier this month and recommend that we continue the study without modifications, and this was an interim, as noted previously.
對於一線非小細胞肺癌研究中的卡那奴單抗,Kerry,Vas 在演講中早些時候提到的是 DMC 在本月早些時候召開了會議,並建議我們繼續研究而不做修改,這是一個臨時性的,如前所述。
We continue to have high thresholds for the interim analysis for both CANOPY-1 and CANOPY-2.
我們對 CANOPY-1 和 CANOPY-2 的中期分析仍然有很高的門檻。
The end analysis step or plan for CANOPY-1 is in the second half of next year.
CANOPY-1 的最終分析步驟或計劃是在明年下半年。
And for CANOPY-2, the end analysis is planned for the first half of next year.
而對於CANOPY-2,最終分析計劃在明年上半年進行。
So those are the overall time lines moving forward.
所以這些是向前發展的總體時間線。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And we do have, Kerry, additional interim analyses, but we're not in a position right now to predict exactly when those are going to happen based on the statistics.
克里,我們確實有額外的中期分析,但我們現在無法根據統計數據準確預測這些分析何時會發生。
We'll of course keep everyone up to date when we have a better visibility.
當我們有更好的知名度時,我們當然會讓每個人都了解最新情況。
On Lutathera, Susanne?
在盧塔瑟拉,蘇珊?
Susanne Schaffert - President of Novartis Oncology
Susanne Schaffert - President of Novartis Oncology
Yes.
是的。
Thank you, Kerry, for the question.
謝謝你,克里,這個問題。
So Lutathera was more or less in line with previous year, reaching $119 million.
所以 Lutathera 或多或少與上一年持平,達到 1.19 億美元。
And it is, as you rightly say, impacted by COVID.
正如你所說的,它受到 COVID 的影響。
When you look at the different dynamics, for the U.S., we had a slight decline of 4%.
當您查看不同的動態時,對於美國,我們略有下降 4%。
But on the other side, in Europe, where the situation opened up again, we saw a growth of 10% versus previous year.
但另一方面,在形勢再次開放的歐洲,我們看到與去年相比增長了 10%。
We remain very confident in Lutathera given the very strong profile of the product.
鑑於 Lutathera 的產品非常強大,我們仍然非常有信心。
As you remember, Lutathera has demonstrated overall survival benefit over some of the statin treatment.
正如您所記得的,Lutathera 已經證明了與某些他汀類藥物治療相比的總體生存益處。
And we see still very high interest for the product.
我們看到對該產品的興趣仍然很高。
We saw some postponement and cancellation of new patient starts, but we're still activating our plan to further growth.
我們看到一些新患者開始的推遲和取消,但我們仍在啟動我們的計劃以進一步增長。
We are reaching out to the community level where over 65% of the patients are treated, and we have very encouraging discussions there.
我們正在接觸超過 65% 的患者接受治療的社區層面,我們在那裡進行了非常令人鼓舞的討論。
So overall, we remain very confident, and the current softness is mostly impacted by COVID.
所以總的來說,我們仍然非常有信心,目前的疲軟主要是受到 COVID 的影響。
And as soon as the situation is released, we expect to have new patients taking up again.
一旦情況公佈,我們預計會有新的患者再次接受治療。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Very good.
很好。
We have a number of questions on the line.
我們有很多問題在線。
I'll ask the next set of questions to please limit yourself to 1 question, no more than 2 subparts.
我會問下一組問題,請限制自己回答 1 個問題,不超過 2 個子部分。
So we could have the next question, operator.
所以我們可以有下一個問題,運營商。
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
Could I ask on Gilenya, just going back to that, whether you can provide us any visibility now on the timing of potential U.S. generics after I think all the sort of legal cases have now been finalized.
我可以問一下 Gilenya,回到那個問題,在我認為所有類型的法律案件現在都已經完成之後,你是否可以讓我們了解潛在的美國仿製藥的上市時間。
And sorry, can I just go back to John, just for a clarification on canakinumab.
對不起,我可以回到約翰那裡,只是為了澄清一下卡納金單抗。
I know you said that there were other interim analysis, I think you said.
我知道你說還有其他中期分析,我想你說過。
But is the second half '21 headline data that you're talking about, is that your best estimate for the final readout of CANOPY-1?
但是,您所說的 21 年下半年標題數據是您對 CANOPY-1 最終讀數的最佳估計嗎?
Or is that your assessment of when we could next hear, which actually could be one of the next interim analysis?
還是您對我們下次何時可以聽到的評估,這實際上可能是下一次中期分析之一?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes.
是的。
I can take both of these.
這兩個我都可以。
On Gilenya, we, of course, are very pleased with the response that the district courts have uphold our patent.
在 Gilenya,我們當然對地區法院支持我們專利的回應感到非常高興。
We do understand the filer has filed an appeal.
我們確實了解申報人已提出上訴。
So over the next 12 to 18 months, that appeal will now unfold.
因此,在接下來的 12 到 18 個月內,這種吸引力將會顯現。
We continue to stand by our patents, including some of the more recent past patents that have been issued.
我們繼續堅持我們的專利,包括一些最近已發布的專利。
So we would expect, again, a court case to potentially happen over the next 12 to 18 months.
因此,我們再次預計,未來 12 到 18 個月內可能會發生一起法庭案件。
And in the meantime, we continue to operate as planned and continue to aggressively defend our IP.
與此同時,我們繼續按計劃運營,並繼續積極捍衛我們的知識產權。
With respect to canakinumab, the final analysis for the second-line study is in the first half of next year.
關於canakinumab,二線研究的最終分析在明年上半年。
And the final analysis for the first-line study is in the second half of next year.
而一線研究的最終分析是在明年下半年。
There is an interim, another interim analysis for both studies, both the second line and the first line.
對於第二行和第一行的兩項研究,都有一個中期分析,另一個中期分析。
Learning from some of the disruptions that have happened with COVID, we would feel more comfortable not providing specific timings until we have a better sense of when exactly those interims will occur.
從 COVID 發生的一些中斷中吸取教訓,我們會更願意不提供具體的時間安排,直到我們更好地了解這些臨時措施何時會發生。
Is that clear, Peter?
清楚了嗎,彼得?
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
That's great.
那太棒了。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
All right.
好的。
Perfect.
完美的。
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
Hopefully, you can hear me okay.
希望你能聽到我的聲音。
Vas, would you mind just setting the tone for the upcoming advisory committee for Entresto in HFrEF.
Vas,您介意為即將到來的 HFrEF Entresto 諮詢委員會定下基調嗎?
Based on your conversations with the regulatory agencies, what should we expect to be the focus of the advisory committee?
根據您與監管機構的對話,我們應該期待諮詢委員會的重點是什麼?
That's one.
那是一個。
And then very quickly, secondly, for Harry.
然後很快,其次,為了哈利。
Harry, kind of can you just remind us for your priorities for capital allocation as we get into kind of next year.
哈利,當我們進入明年的時候,你能不能提醒我們你在資本配置方面的優先事項。
And especially, how are you thinking about kind of stock buybacks versus business development?
尤其是,您如何看待股票回購與業務發展?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes, Keyur, thank you for the questions.
是的,Keyur,謝謝你的提問。
On the advisory committee, we'll see ultimately what the FDA focuses on.
在諮詢委員會上,我們最終將看到 FDA 關注的重點。
I think our expectation is 2 major areas of focus.
我認為我們的期望是兩個主要關注領域。
One, on the primary endpoint, as you know, the centrally adjudicated result was narrowly missed.
一,如您所知,在主要終點上,中央裁定的結果被差點遺漏。
The investigator adjudicator result was, in fact, positive and met statistical significance.
事實上,研究者裁決者的結果是積極的並且符合統計學意義。
A reanalysis by an independent group also indicated a positive result.
一個獨立小組的重新分析也表明了積極的結果。
So parsing those various results, I think, will be 1 major topic.
因此,我認為解析這些不同的結果將是一個主要話題。
And then looking at the various sub group analysis.
然後看各個亞組分析。
There was a clear trend for benefit in patients with an EF up to a certain cutoff, roughly 57%, as well as in women and how the FDA might navigate all of the above from a labeling perspective.
EF 達到某個臨界值(大約 57%)的患者以及女性以及 FDA 如何從標籤的角度駕馭上述所有方面都有明顯的獲益趨勢。
We expect those to be the major topics.
我們希望這些成為主要話題。
So from a safety perspective, don't expect major discussions.
因此,從安全角度來看,不要指望進行重大討論。
Harry, on the capital allocation?
哈利,關於資本分配?
Harry Kirsch - CFO
Harry Kirsch - CFO
Yes, Keyur.
是的,凱爾。
So thank you.
所以謝謝。
As you probably imagine, there is no change in our capital allocation strategy.
正如您可能想像的那樣,我們的資本配置策略沒有變化。
First priority always has to be investment in the organic business.
首要任務始終是投資有機業務。
The second priority being an attractive growing end year dividend in Swiss franc, which we again expect to pay out in usually March of next year, should AGM, as always approve.
第二個優先事項是以瑞士法郎為單位的具有吸引力的增長年終股息,如果年度股東大會一如既往地批准,我們預計通常會在明年 3 月支付。
Third priority, value-creating bolt-on M&A.
第三個優先事項,創造價值的附加併購。
And fourth, share buybacks.
第四,股票回購。
So it depends very much what opportunities do we find.
所以這在很大程度上取決於我們能找到什麼機會。
We all know that these are, usually on M&A bolt-on, quite heavy premiums have to be paid.
我們都知道,這些通常是併購附加的,必須支付相當高的溢價。
And so we are super selective on them.
所以我們對它們非常挑剔。
And so let's see if we find them up to 5% of our market cut.
因此,讓我們看看我們是否發現它們最多占我們市場份額的 5%。
And should we not find them, of course, share buybacks.
當然,如果我們找不到他們,股票回購。
I expect always to be part of our capital allocation, but the fourth priority.
我希望始終成為我們資本配置的一部分,但這是第四個優先事項。
Having said that, we always do some share buybacks to avoid any dilution from our employee compensation programs, but that we don't announce that the ongoing commitment to not dilute our shareholders.
話雖如此,我們總是進行一些股票回購以避免我們的員工薪酬計劃受到任何稀釋,但我們沒有宣布持續承諾不稀釋我們的股東。
Operator
Operator
The next question comes from the line of Simon Baker from Redburn.
下一個問題來自 Redburn 的 Simon Baker。
Simon P. Baker - Head of Pharmaceutical Research
Simon P. Baker - Head of Pharmaceutical Research
Firstly, a question on Sandoz.
首先,關於 Sandoz 的問題。
I wonder, Richard, could you give us an idea of how important label carve-outs of generics are for you in light of the recent ruling that potentially renders them illegal in the Glaxo-Teva case earlier this month.
我想知道,理查德,鑑於最近的裁決可能使本月早些時候在葛蘭素 - 梯瓦 (Glaxo-Teva) 的案件中,仿製藥的標籤剝離對你來說是非法的,你能否告訴我們仿製藥的標籤剝離對你有多重要。
And then secondly, I noticed on the slides, the mention of Luxturna in a few of the footnotes, but no other comment.
其次,我注意到幻燈片上的一些腳註中提到了 Luxturna,但沒有其他評論。
So I'm looking if you could just give us an update on where you stand with Luxturna.
因此,我正在尋找您是否可以向我們提供有關您對 Luxturna 的立場的最新信息。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Simon.
謝謝你,西蒙。
On Sandoz label carve-outs, Richard?
關於山德士標籤剝離,理查德?
Richard Saynor - CEO of Sandoz
Richard Saynor - CEO of Sandoz
Yes.
是的。
No, it's a really important and interesting topic.
不,這是一個非常重要和有趣的話題。
I mean clearly we're watching the progression now with Teva, I think, going to appeal on the GSK Coreg case.
我的意思很明顯,我們現在正在觀察梯瓦的進展,我認為,將對 GSK Coreg 案提出上訴。
Clearly, the use of skinny labels has been a routine route to market, particularly in the U.S. It really goes against really the provision that we put in place.
顯然,使用緊身標籤一直是進入市場的常規途徑,尤其是在美國。這確實違反了我們制定的規定。
And clearly, as an industry, it's something we need to explore and consider how we challenge.
顯然,作為一個行業,這是我們需要探索和考慮如何挑戰的東西。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
On Luxturna, Marie-France?
在 Luxturna,Marie-France?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Yes.
是的。
So as you know, we have the rights for Luxturna ex U.S., and we have certainly made a lot of progress in making sure that we prepare centers from a training perspective to manage the product.
如您所知,我們擁有 Luxturna ex U.S. 的權利,我們在確保從培訓角度準備中心以管理產品方面確實取得了很大進展。
I will say that during this COVID period, we did see a complete stop to those surgeries as they were considered nonurgent.
我會說,在這段 COVID 期間,我們確實看到這些手術完全停止,因為它們被認為是不緊急的。
What we are seeing is we are seeing pickup happen now.
我們所看到的是我們現在正在看到皮卡發生。
So the hope has to be that we can continue to see these children getting use of Luxturna.
所以希望我們可以繼續看到這些孩子使用 Luxturna。
We've seen an increase in approvals overall.
我們已經看到總體批准數量有所增加。
We're working on reimbursement and making sure that centers are basically apt and trained to administer the product.
我們正在努力報銷,並確保這些中心基本上適合併經過培訓來管理產品。
So definitely a slowdown, but hopefully, for the rest of the year, we'll get as many children treated as possible.
所以肯定會放緩,但希望在今年餘下的時間裡,我們會得到盡可能多的兒童治療。
Operator
Operator
Your next question comes from the line of Florent Cespedes from Societe Generale.
您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
Two quick ones.
兩個快的。
First for, Marie-France.
首先是Marie-France。
On Mayzent, could you please elaborate on what is behind the acceleration of the product?
在Mayzent,能否請您詳細說明一下產品加速的背後是什麼?
And if it is sustainable?
如果它是可持續的?
My second question on ligelizumab for John.
我對約翰的第二個關於 ligelizumab 的問題。
Could you share with us how you believe you will differentiate these products versus your BTK inhibitor, which is in Phase II?
您能否與我們分享您認為您將如何將這些產品與處於 II 期的 BTK 抑製劑區分開來?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Florent.
謝謝,弗洛倫特。
Mayzent, Marie-France?
Mayzent,瑪麗-法蘭西?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Yes.
是的。
So I mean we have seen an acceleration in Mayzent.
所以我的意思是我們已經看到了 Mayzent 的加速發展。
We're very happy to show 41% quarter-over-quarter growth.
我們很高興看到 41% 的季度環比增長。
This is a unique set of patients, and Mayzent has unique data in this population showing really great results in the SPMS population.
這是一組獨特的患者,Mayzent 在該人群中擁有獨特的數據,在 SPMS 人群中顯示出非常好的結果。
We've seen growth despite COVID, and this is just a tribute to the fact that physicians are identifying these patients and are bringing these patients to treatment.
儘管出現了 COVID,但我們已經看到了增長,這只是對醫生正在識別這些患者並將這些患者進行治療這一事實的致敬。
We've got breadth in our Rx, patient onboarding is happening and it's easier.
我們的 Rx 範圍很廣,患者入職正在發生,而且更容易。
So we've improved when it comes to that.
所以我們在這方面有所改進。
And also, we have a clear positioning.
而且,我們有明確的定位。
We've also launched in additional markets.
我們還在其他市場推出。
So we've seen that Germany has about 1,000 patients.
所以我們看到德國有大約1000名患者。
We've also recently seen the nice nod from the U.K. And we're preparing to launch in China and Japan.
我們最近也看到了英國的好評。我們正準備在中國和日本推出。
So I think you can continue to see this growth quarter-over-quarter and year-over-year with Mayzent.
因此,我認為您可以繼續看到 Mayzent 的季度環比和同比增長。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And John, on ligelizumab.
和約翰,關於ligelizumab。
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes.
是的。
Yes.
是的。
Thanks, Florent.
謝謝,弗洛倫特。
Thanks for the question on ligelizumab.
感謝有關 ligelizumab 的問題。
As you know, ligelizumab is our anti-IgE that forms free complexes and binds up the free IgE.
如您所知,ligelizumab 是我們的抗 IgE,可形成游離複合物並結合游離 IgE。
We did have a publication earlier in the year in New England Journal, which compared ligelizumab in CSU, where we showed significant benefits at 42% versus 26% in Xolair.
今年早些時候,我們確實在《新英格蘭雜誌》上發表了一篇文章,比較了 CSU 中的 ligelizumab,我們在 Xolair 中顯示出 42% 和 26% 的顯著獲益。
So based on that, we are moving forward, obviously, and are fully recruited in our trial for ligelizumab.
因此,基於此,我們顯然正在向前邁進,並且在我們的 ligelizumab 試驗中被完全招募。
We expect the readout to be in the second half of next year.
我們預計將在明年下半年公佈。
You asked about differentiation versus remibrutinib BTK inhibitor.
您詢問了關於分化與瑞布替尼 BTK 抑製劑的比較。
Currently, we're still looking at -- we're awaiting the full results for remibrutinib in CSU.
目前,我們仍在研究——我們正在等待 CSU 中瑞布替尼的完整結果。
So obviously, for remibrutinib, this is an oral versus ligelizumab being a subcu formulation.
很明顯,對於瑞布替尼來說,這是一種口服製劑,而 ligelizumab 是一種 subcu 製劑。
So as we get more information on remibrutinib, I think we'll be able to clarify what the differentiation is between the 2 agents.
因此,隨著我們獲得有關瑞布替尼的更多信息,我認為我們將能夠闡明這兩種藥物之間的區別。
Operator
Operator
The next question comes from the line of Richard Vosser from JPMorgan.
下一個問題來自摩根大通的 Richard Vosser。
Richard Vosser - Senior Analyst
Richard Vosser - Senior Analyst
One, please.
一個,請。
You talked, Vas, in the opening remarks about continued improvement in the U.S. prescriptions.
Vas,您在開場白中談到了美國處方的持續改進。
We've seen in terms of COVID coming back with a vengeance maybe in Europe.
我們已經看到 COVID 可能在歐洲捲土重來。
So just your thoughts on how new patient starts and your therapies are going in Europe and outside the U.S. to just give us a flavor going into Q4.
因此,只需您對新患者如何開始以及您的療法在歐洲和美國以外的情況的想法,就可以讓我們了解進入第四季度的情況。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes.
是的。
Thanks, Richard.
謝謝,理查德。
I think it's a very variable situation.
我認為這是一個非常多變的情況。
What I do believe is that it's variable by country and jurisdiction.
我確實相信它會因國家和司法管轄區而異。
What I think is clearly the case, though, is health care systems have, one, gotten better at managing COVID, severe COVID cases, understanding when to hospitalize, when to bring patients into the ICU and, therefore, better manage the load.
不過,我認為很明顯的情況是,醫療保健系統在管理 COVID、嚴重 COVID 病例、了解何時住院、何時將患者送入 ICU 方面做得更好,從而更好地管理負荷。
I think, second, there's a broad recognition broadly also published in the academic literature, that there is a substantial impact of this pandemic on noncommunicable diseases at large.
我認為,第二,學術文獻中也廣泛發表了廣泛的認識,即這種流行病對整個非傳染性疾病產生了重大影響。
And there's, I think, a broadening desire in the public health community not to see that expand.
我認為,公共衛生界越來越希望不要看到這種擴大。
So trying to maintain patient visit schedules from -- in oncology in all of the various noncommunicable disease categories, rheumatology, cardiology, pulmonology, dermatology, ophthalmology, et cetera.
因此,試圖保持患者就診時間表 - 在所有各種非傳染性疾病類別的腫瘤學中,風濕病學、心髒病學、肺病學、皮膚病學、眼科等。
And then third, from just the economic financial sustainability, health care systems are quite motivated based on my conversations to also maintain their normal activities to the extent possible.
第三,僅從經濟財務可持續性來看,根據我的談話,醫療保健系統非常積極地也盡可能維持其正常活動。
I think, for all those reasons, we certainly are seeing an impact of the second -- next wave in Europe, but there hasn't been thus far as severe as what we saw in April and May.
我認為,出於所有這些原因,我們肯定會看到第二波——下一波在歐洲的影響,但到目前為止還沒有我們在 4 月和 5 月看到的那麼嚴重。
And as Harry noted, we're hopeful that, that will remain the case.
正如哈利指出的那樣,我們希望這種情況仍然存在。
Now if we do see significant disruptions, of course, we'll have to adjust accordingly.
現在,如果我們確實看到了嚴重的中斷,當然,我們將不得不做出相應的調整。
And I actually think that's a similar situation in the U.S. So the U.S. appears right now to be a bit more resilient in making sure the health care systems operate also, I think, because of the financial strain, those systems have been under.
實際上,我認為美國的情況也類似。因此,我認為,由於財政壓力,美國現在在確保醫療保健系統也能正常運轉方面似乎更有彈性。
Thank you, Richard.
謝謝你,理查德。
Operator
Operator
The next question comes from the line of Tim Anderson from Wolfe Research.
下一個問題來自 Wolfe Research 的 Tim Anderson。
Unidentified Analyst
Unidentified Analyst
This is [Richard Ladner] for Tim Anderson.
這是蒂姆·安德森的[理查德·拉德納]。
My question -- one please, regarding LAG525, your LAG-3 inhibitor.
我的問題——請提一個關於 LAG525,您的 LAG-3 抑製劑的問題。
In Q2, it was shown as a 2023 submission.
在第二季度,它顯示為 2023 年的提交。
It's dropped off of the submission slide.
它從提交幻燈片上掉下來了。
Wondering if you had some underwhelming data with this and if novel and the way it's changed its prioritization.
想知道你是否有一些令人印象深刻的數據,以及它是否新穎以及它改變優先級的方式。
I know it's not a high-priority program, but it's relevant to one of your IO competitors, Bristol Myers Squibb, who have a more advanced LAG-3 program.
我知道這不是一個高優先級的計劃,但它與您的 IO 競爭對手之一 Bristol Myers Squibb 相關,他們擁有更先進的 LAG-3 計劃。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks Richard.
謝謝理查德。
John, I don't know if you have the latest on LAG-3.
約翰,我不知道你是否有最新的 LAG-3。
I certainly don't.
我當然不會。
So John?
那麼約翰?
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes so -- yes, based on portfolio prioritization, Tim, we made some decisions, and the area that we were looking at was LAG in triple-negative breast cancer.
是的 - 是的,基於投資組合的優先級,蒂姆,我們做出了一些決定,我們正在研究的領域是三陰性乳腺癌中的 LAG。
And we decided not to move forward in that indication.
我們決定在那個跡像中不前進。
So that's why it's dropped off.
所以這就是它下架的原因。
Operator
Operator
Next question comes from the line of Jo Walton from Credit Suisse.
下一個問題來自瑞士信貸的 Jo Walton。
Jo Walton - MD
Jo Walton - MD
Two quick ones.
兩個快的。
Do you have any visibility on Sandostatin LAR generics?
您對 Sandostatin LAR 仿製藥有任何了解嗎?
And do you -- I believe it was mentioned that Sandostatin generics in Europe were a factor?
你——我相信有人提到歐洲的 Sandostatin 仿製藥是一個因素嗎?
Are there more countries?
還有更多的國家嗎?
Is that becoming a more serious issue?
這會成為一個更嚴重的問題嗎?
And the second one on Cosentyx, please.
請在 Cosentyx 上發布第二個。
I know that you say that there's been a drop in visits to derm.
我知道你說皮膚訪問量有所下降。
But we are seeing in the first 3 quarters of this year substantially higher prescription than sales growth.
但我們在今年前三個季度看到處方藥的增長遠高於銷售增長。
So there's obviously some increased competition here.
因此,這裡的競爭顯然有所增加。
And I wonder if you could address the competition angle as much as the lack of derm patients in the U.S. And I believe in Europe, you said there's now mandatory use of biosimilars.
我想知道你是否可以像美國缺乏皮膚患者一樣解決競爭問題。我相信在歐洲,你說現在強制使用生物仿製藥。
I wondered if you could expand on that comment, too.
我想知道您是否也可以擴展該評論。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Jo.
謝謝,喬。
So first on Sandostatin, Susanne?
那麼首先是Sandostatin,Susanne?
Susanne Schaffert - President of Novartis Oncology
Susanne Schaffert - President of Novartis Oncology
Yes.
是的。
Thank you, Jo.
謝謝你,喬。
So as you saw Sandostatin sales were declining, and this was mostly driven by generic erosion in Europe.
因此,正如您所見,Sandostatin 的銷售額正在下降,這主要是由於歐洲的仿製藥侵蝕所致。
At date, there is one generic that has received marketing authorization in Europe and have started commercial activities in limited countries, mainly Germany, France, U.K. and a few other small countries.
迄今為止,有一種仿製藥已在歐洲獲得上市許可,並已在有限的國家開展商業活動,主要是德國、法國、英國和其他一些小國家。
On the U.S. side, we know that there's 1 generic application going through regulatory process.
在美國方面,我們知道有 1 個通用申請正在通過監管程序。
But at the moment, we have no further update.
但目前,我們沒有進一步的更新。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And then on Cosentyx competitive dynamics, Marie-France?
然後關於 Cosentyx 的競爭動態,Marie-France?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Yes.
是的。
So I'll just start off by saying that it's a very competitive class, and it's getting more competitive by the quarter almost.
所以我首先要說這是一個非常有競爭力的課程,而且幾乎到本季度它的競爭力就會越來越強。
But despite this, Cosentyx continues to deliver very strong growth.
但儘管如此,Cosentyx 繼續實現非常強勁的增長。
And if I could just take you through it.
如果我能帶你通過它。
We have -- first of all, we had our first $1 billion quarter, which I think is definitely something to celebrate.
我們有——首先,我們有第一個 10 億美元的季度,我認為這絕對是值得慶祝的事情。
And we have seen a slowdown in the market.
我們已經看到市場放緩。
So if we look at the expansion of the market this year versus last year, I mean, there's clearly been a slowdown.
因此,如果我們看一下今年與去年相比的市場擴張,我的意思是,顯然已經放緩。
There's been more competition.
競爭更加激烈。
We'll get to the biosimilars question in a second.
我們稍後會談到生物仿製藥問題。
And what we have seen is we've seen a faster recovery in the rheumatology space versus the dermatology space.
我們所看到的是,我們已經看到風濕病領域與皮膚病領域相比恢復得更快。
If we look a little bit more carefully at the U.S., we're maintaining TRx share and NBRx share in derm, even though you see this lower recovery and the increased competition of IL-23.
如果我們更仔細地看一下美國,我們將維持 TRx 份額和 NBRx 在真皮中的份額,儘管您看到這種較低的恢復率和 IL-23 的競爭加劇。
In the wound space, we're actually growing 3x TRx versus the market year-over-year.
在傷口領域,與市場相比,我們實際上增長了 3 倍的 TRx。
So what our aspiration is, is to maintain our share in derm and accelerate in the rheumatology space.
因此,我們的願望是保持我們在皮膚領域的份額並在風濕病領域加速發展。
If I look at EU, where biosimilars are -- have entered and where there's mandatory use, so it's exclusively in some of the markets in the EU, and namely Germany, Spain and the U.K., what we've done is we've actually maintained the share in dermatology after the initial entry of biosimilars.
如果我看看歐盟,生物仿製藥已經進入並強制使用,所以它只在歐盟的一些市場,即德國、西班牙和英國,我們所做的是我們實際上已經在生物類似藥首次進入後,保持了皮膚科的份額。
And the same with the rheumatology space where we've seen the biosimilars being more used.
風濕病領域也是如此,我們已經看到生物仿製藥被更多地使用。
So what this means actually is that we're just seeing a delay in use for Cosentyx in Europe.
所以這實際上意味著我們只是看到 Cosentyx 在歐洲的使用延遲。
We still maintain a #1 or #2 position in most EU major markets.
在大多數歐盟主要市場中,我們仍然保持第一或第二的位置。
And then with China, we're outperforming incumbent biologics, and we expect NRDL listing in the first half of this year.
然後在中國,我們的表現優於現有的生物製品,我們預計今年上半年 NRDL 上市。
So this all leads us to believe that through the complete treatment approach of Cosentyx, we see very broad indications from the PsO space to the actual SpA spectrum.
所以這一切都讓我們相信,通過 Cosentyx 的完整治療方法,我們看到了從 PsO 空間到實際 SpA 譜的非常廣泛的跡象。
The fact that we believe that we and others will continue to grow this market, if you can consider the market penetration rates or the biologic penetration rates in both rheum and derm, they're still relatively low.
事實上,我們相信我們和其他人將繼續發展這個市場,如果你可以考慮市場滲透率或大黃和真皮的生物滲透率,它們仍然相對較低。
And the fact that Cosentyx, we're investing in future indications, you can anticipate 3 additional indications in the rheum space, 3 additional indications in the derm space.
事實上,我們正在投資於未來的適應症 Cosentyx,您可以預期在大黃領域有 3 個額外的適應症,在皮膚領域有 3 個額外的適應症。
This will address approximately an additional 3.5 million patients.
這將解決大約另外 350 萬患者。
So for these reasons, we believe that Cosentyx, despite the slowdown of COVID, despite the competition, despite the biosimilars, we have the potential to go beyond $5 billion in sales.
因此,出於這些原因,我們相信 Cosentyx,儘管 COVID 放緩,儘管存在競爭,儘管有生物仿製藥,但我們仍有可能超過 50 億美元的銷售額。
Operator
Operator
The next question comes from the line of Naresh Chouhan from Intron Health.
下一個問題來自 Intron Health 的 Naresh Chouhan。
Naresh Chouhan
Naresh Chouhan
Just one big-picture one on ESG.
只有一張關於 ESG 的大圖。
It's obviously been a big topic when discussing Novartis with investors, and you clearly made a concerted effort to improve the rating.
在與投資者討論諾華時,這顯然是一個大話題,您顯然齊心協力提高評級。
To what extent have those efforts surprised you and that they actually led to better financial or operational outcomes?
這些努力在多大程度上讓您感到驚訝,它們實際上帶來了更好的財務或運營成果?
And is it unfair to assume that all the ESG efforts currently expense and the bottom line?
假設當前所有 ESG 努力都花費了成本和底線,這是否不公平?
Just a bit of color around what you've seen.
你所看到的只是一點顏色。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Naresh.
謝謝,納雷什。
I think the ESG efforts have had multiple benefits for us.
我認為 ESG 努力為我們帶來了多重好處。
It's been a big focus for us.
這對我們來說是一個很大的焦點。
We're really pleased not only to have gotten important ratings, the #1 ratings across many of the agencies, also in various specialty agencies in climate and diversity also moved off of the red list for MSCI, which I think a lot of investors had on their minds.
我們真的很高興不僅獲得了重要的評級,許多機構的排名第一,而且在氣候和多樣性方面的各種專業機構也從 MSCI 的紅色名單中移出,我認為很多投資者都有在他們的腦海中。
So all of that is cleared off the table.
因此,所有這些都被清除了。
But I see a few fundamental benefits for ESG.
但我看到了 ESG 的一些基本好處。
First, with our own associates, it's a huge motivator to be a leader in the space.
首先,與我們自己的同事一起,成為該領域的領導者是一個巨大的動力。
I think for our people, more than 50% millennials, this is a huge topic.
我認為對於我們的員工,超過 50% 的千禧一代來說,這是一個巨大的話題。
So we see it as an element of our own story internally.
因此,我們在內部將其視為我們自己故事的一個元素。
I think, second, with a broader stakeholder group, the issuance -- as indicated that the issuance of our bond led to me to get very positive feedback from a range of stakeholders, ranging from ministers of health, very senior people in government, the Gates Foundation.
我認為,其次,與更廣泛的利益相關者群體一起發行——正如我們債券的發行使我從一系列利益相關者那裡得到非常積極的反饋,包括衛生部長、政府高級官員、蓋茨基金會。
And so I think it creates the ability to have a broader conversation about your company and the impact you're trying to have.
所以我認為它創造了就你的公司和你試圖產生的影響進行更廣泛對話的能力。
And then lastly, we do believe that getting much more efficient on how we use energy, much more diverse in how we source and bring in people into the company, getting -- to be a leader in building markets in emerging markets and low-income and low-middle-income countries through our work in Africa, all of these things will benefit Novartis strategically for the long term from a talent market and all of the fundamentals of the business.
最後,我們確實相信,在我們如何使用能源方面變得更加高效,在我們如何採購和引進人才方面更加多樣化,成為在新興市場和低收入市場建立市場的領導者通過我們在非洲的工作和中低收入國家,所有這些都將從人才市場和業務的所有基本面長期戰略性地使諾華受益。
So I actually think it's totally sensible.
所以我實際上認為這是完全明智的。
We talked about it as a leadership team in a committee that I chair.
我們在我主持的一個委員會中作為領導團隊討論過它。
We systematically have the targets, which we publish transparently.
我們系統地制定了目標,我們透明地發布了這些目標。
I think we have a leadership team that's very passionate about it.
我認為我們有一個對此充滿熱情的領導團隊。
And again, in the long run, it will -- it won't show up in the quarters, but it will show up in the long-run trajectory of the company, that I'm convinced of.
再說一次,從長遠來看,它不會出現在季度中,但會出現在公司的長期發展軌跡中,我對此深信不疑。
Thanks for the question, Naresh.
謝謝你的問題,納雷什。
Operator
Operator
And the final question comes from the line of Richard Parkes from Exane BNP.
最後一個問題來自 Exane BNP 的 Richard Parkes。
Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team
Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team
Just one on iptacopan.
iptacopan 上只有一個。
It looks like you're also initiating a Phase III in IgA nephropathy.
看起來您也在啟動 IgA 腎病的 III 期治療。
So I know you might not want to talk about those Phase II data until it's published, but maybe you could compare your experience with Phase II trials in C3 glomerulopathy and IgA nephropathy to the previously reported anecdotal experience with eculizumab.
所以我知道你可能不想在這些 II 期數據發表之前談論它,但也許你可以將你在 C3 腎小球病和 IgA 腎病的 II 期試驗中的經驗與之前報導的依庫珠單抗的軼事經驗進行比較。
And also, how you're thinking about the safety of the drug in terms of infection risk and how that's developing.
而且,你是如何考慮藥物在感染風險方面的安全性以及它是如何發展的。
I hear conflicting opinions from experts whether there's likely to be a greater or lesser risk of serious infection with factor B inhibition?
我從專家那裡聽到了相互矛盾的意見,是否存在 B 因子抑制導致嚴重感染的風險更大或更小?
So I'd be interested to hear your perspective.
所以我很想听聽你的觀點。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks for the question, Richard.
謝謝你的問題,理查德。
John?
約翰?
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes.
是的。
So thanks for the question, Richard.
所以謝謝你的問題,理查德。
Across the board, as you know, for iptacopan, we're looking at multiple indications, PNH as well as C3G, IgA as well as idiopathic membranous nephropathy.
如您所知,我們正在全面研究 iptacopan 的多種適應症,PNH 以及 C3G、IgA 以及特發性膜性腎病。
For -- as we're looking across the board for C3G, what we see is, obviously, the data that we shared recently.
因為——當我們全面審視 C3G 時,我們看到的顯然是我們最近共享的數據。
For IgA, we're -- the full data set is going to be available early part of next year.
對於 IgA,我們將在明年年初提供完整的數據集。
As we look at the opportunity, it is a -- there's no disease-modifying treatments out there currently.
當我們看到這個機會時,這是一個 - 目前沒有改善疾病的治療方法。
And so the profile that we're seeking is one where we do believe there's benefit.
因此,我們正在尋求的配置文件是我們確實認為有好處的配置文件。
You asked specifically about infection risk.
您特別詢問了感染風險。
So far, based on our Phase II studies, we see that it's well tolerated.
到目前為止,根據我們的 II 期研究,我們發現它的耐受性很好。
We haven't seen significant increases in infections across the board.
我們還沒有看到全面感染的顯著增加。
And that's across both IgA, C3G as well as in the PNH.
這在 IgA、C3G 以及 PNH 中都存在。
So I think with all of that information, we will have a large pool of safety information as we move forward in all of these indications.
因此,我認為有了所有這些信息,隨著我們在所有這些跡像中取得進展,我們將擁有大量的安全信息。
So I'll leave it there.
所以我會把它留在那裡。
Hopefully, that answers your question.
希望這能回答你的問題。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Perfect.
完美的。
Thanks, everyone, for joining the call.
謝謝大家加入電話會議。
I hope everyone stays safe and healthy and energized in these difficult times.
我希望每個人都能在這些困難時期保持安全、健康和精力充沛。
We'll continue to drive the growth of Novartis.
我們將繼續推動諾華的增長。
We're confident in the long-term outlook of the company.
我們對公司的長期前景充滿信心。
I hope increasingly all of you will be as well.
我希望你們所有人也越來越好。
And we'll look forward to keeping you up to date.
我們期待讓您了解最新信息。
Thank you.
謝謝你。
Operator
Operator
Thank you.
謝謝你。
Ladies and gentlemen, that does conclude your call for today.
女士們,先生們,你們今天的通話到此結束。
Thank you all for participating, and you may now disconnect.
感謝大家的參與,您現在可以斷開連接。