Novartis AG (NVS) 2020 Q1 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good morning and good afternoon and welcome to the Novartis Q1 2020 Results Release Conference Call and Live Audio Webcast. (Operator Instructions) The conference is being recorded. (Operator Instructions) A recording of the conference call, including the Q&A session, would be available on our website shortly after the call ends. (Operator Instructions)

    早上好,下午好,歡迎來到諾華 2020 年第一季度業績發布會電話會議和現場音頻網絡直播。 (操作員說明)正在錄製會議。 (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。 (操作員說明)

  • With that, I would like to hand over to Mr. Samir Shah, Global Head of Investor Relations. Please go ahead, sir.

    至此,我想向投資者關係全球主管 Samir Shah 先生匯報。請繼續,先生。

  • Samir Shah - Global Head of IR

    Samir Shah - Global Head of IR

  • Thank you, and welcome, everybody, to Novartis' First Quarter 2020 Conference Call. Before we get started, I just want to read you the safe harbor statement.

    謝謝大家,歡迎大家參加諾華 2020 年第一季度電話會議。在我們開始之前,我只想閱讀安全港聲明。

  • The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K that, respectively, were filed with and furnished to the U.S. Securities and Exchange Commission.

    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。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。有關其中一些因素的描述,請參閱公司的 20-F 表格及其最近的 6-K 表格季度業績,這些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。

  • I'd like to thank you all for participating in today's call and now hand across to Vas.

    我要感謝大家參加今天的電話會議,現在轉交給 Vas。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thank you, Samir, and thanks, everyone, for joining today's call. With me today, I have Harry Kirsch, our Chief Financial Officer; Marie-France Tschudin, President of Novartis Pharmaceuticals; Susanne Schaffert, President, Novartis Oncology; John Tsai, our Head of Global Drug Development and CMO; Richard Saynor, the CEO of Sandoz; and Shannon Klinger, our Group General Counsel.

    謝謝你,薩米爾,謝謝大家加入今天的電話會議。今天和我在一起的還有我們的首席財務官 Harry Kirsch; Marie-France Tschudin,諾華製藥總裁; Susanne Schaffert,諾華腫瘤學總裁;我們的全球藥物開發主管兼首席營銷官 John Tsai;山德士首席執行官 Richard Saynor;和我們的集團總法律顧問 Shannon Klinger。

  • So moving to Slide 5. This quarter, we were able to maintain strong operational performance while supporting the global response to COVID-19. When you look at our operational performance, sales grew 13%, core operating income grew 34%. This included the effect of approximately $400 million of forward buying we saw across a range of brands. When you strip out that $400 million effect, sales grew 9% and core operating income grew 22%. So very healthy and strong growth in the quarter with solid margin expansion both in Innovative Medicines and Sandoz, excluding the COVID effect.

    所以轉到幻燈片 5。本季度,我們能夠保持強勁的運營業績,同時支持全球對 COVID-19 的響應。當您查看我們的運營業績時,銷售額增長了 13%,核心營業收入增長了 34%。這包括我們在一系列品牌中看到的大約 4 億美元的遠期購買的影響。如果剔除這 4 億美元的影響,銷售額增長了 9%,核心營業收入增長了 22%。本季度非常健康和強勁的增長,創新藥物和山德士的利潤率都在穩步增長,不包括 COVID 效應。

  • Now moving to our pipeline. We had a busy quarter once again in delivering our pipeline to deliver long-term growth. First, with respect to Zolgensma, positive CHMP opinion and a Japanese approval. With respect to Cosentyx, we had a positive CHMP opinion in non-radiographic axial SpA. ofatumumab and inclisiran had their filings accepted in the U.S. and EU, and both filings are on track with FDA.

    現在轉到我們的管道。在交付我們的管道以實現長期增長方面,我們再次經歷了一個繁忙的季度。首先,關於 Zolgensma,積極的 CHMP 意見和日本的批准。關於 Cosentyx,我們對非放射軸性 SpA 有積極的 CHMP 意見。 ofatumumab 和 inclisiran 的申請已在美國和歐盟獲得接受,這兩項申請都在 FDA 的軌道上。

  • Entresto, we submitted the -- have passed submission to the FDA. Beovu had its approval in a range of markets. And we also had a priority review for capmatinib and fast track designation for TQJ, our antisense RNA for Lp(a).

    Entresto,我們提交了 - 已通過提交給 FDA。 Beovu 在一系列市場獲得了認可。我們還對 capmatinib 進行了優先審查,並為 TQJ(我們的 Lp(a) 反義 RNA)指定了快速通道。

  • Now we also, I think, demonstrated in the quarter a very robust pandemic response. I'd like to walk you through in a little bit more detail how we've set up to respond to the pandemic at Novartis. So moving to Slide 6.

    我認為,現在我們也在本季度展示了非常強大的流行病應對措施。我想更詳細地向您介紹我們如何在諾華應對大流行病。所以轉到幻燈片 6。

  • Throughout the quarter and through the remainder of this year, we want to demonstrate our relentless commitment to associates, patients, health care providers and society. In each one of these areas, we've set up clear efforts, task forces to ensure that we're really trying to do the right things to ensure our business continuity, but also that we're serving all of these stakeholders.

    在整個季度和今年剩餘時間裡,我們希望展示我們對員工、患者、醫療保健提供者和社會的不懈承諾。在這些領域中的每一個領域,我們都建立了明確的工作組和工作組,以確保我們確實在努力做正確的事情以確保我們的業務連續性,而且我們正在為所有這些利益相關者提供服務。

  • So taking each in turn, if we move to Slide 7, starting with business continuity and the manufacturing and supply chain operations, we put in place robust plan across our suppliers, our own operations and our dealing with customers to ensure there's no disruption in our ability to deliver medicines to patients.

    因此,如果我們依次轉到幻燈片 7,從業務連續性以及製造和供應鏈運營開始,我們會在我們的供應商、我們自己的運營和與客戶的交易中製定強有力的計劃,以確保我們的業務不會中斷向患者提供藥物的能力。

  • With respect to suppliers, we have excellent transparency across the value chain. We've been working in real-time to adjust our inventory levels. And it's worth noting that less than 2% of our sales are supported by APIs that are single-sourced from China and India, giving us strong resilience in that supply chain.

    對於供應商,我們在整個價值鏈中具有出色的透明度。我們一直在實時調整庫存水平。值得注意的是,我們不到 2% 的銷售額是由來自中國和印度的單一來源的 API 支持的,這使我們在該供應鏈中具有很強的彈性。

  • With respect to our own operations, we've really put in place excellent plans across our supply network to ensure that we're able to maintain solid manufacturing operations and are currently maintaining greater than 6 months of inventory on key brands.

    關於我們自己的運營,我們確實在我們的供應網絡中製定了出色的計劃,以確保我們能夠維持穩健的製造運營,並且目前維持超過 6 個月的主要品牌庫存。

  • And then lastly, in terms of supply reliability with customers, we're achieving currently 99.5% customer service levels across our Innovative Medicines portfolio.

    最後,在與客戶的供應可靠性方面,我們目前在我們的創新藥物產品組合中實現了 99.5% 的客戶服務水平。

  • Now moving to clinical trials on Slide 8. First and foremost, it's important to highlight our regulatory submissions for 2020 remain on track. And our -- COVID-19 impact on our clinical trials is largely manageable. You can see here a list of our key regulatory submissions. They are continuing to progress. We're managing them well with the relevant regulators.

    現在轉到幻燈片 8 上的臨床試驗。首先,重要的是要強調我們在 2020 年提交的監管文件仍按計劃進行。我們的——COVID-19 對我們臨床試驗的影響在很大程度上是可控的。您可以在此處查看我們提交的主要監管文件列表。他們正在繼續進步。我們正在與相關監管機構一起妥善管理它們。

  • Now with respect to clinical trials, we have over 300 trials currently operating with 96,000 patients. The only disruptions we're seeing is primarily studies that are in the start-up phase or in the planning phase, where we have some slowdown in new enrollments on ongoing studies and start-up with new studies. But I would say that in studies that are more in a maintenance or closeout situation, we've been able to manage extremely well with minimal disruptions.

    現在,在臨床試驗方面,我們目前有 300 多項試驗,涉及 96,000 名患者。我們看到的唯一中斷主要是處於啟動階段或計劃階段的研究,在這些階段,正在進行的研究的新入學人數和新研究的啟動有所放緩。但我想說的是,在更多處於維護或收尾情況的研究中,我們已經能夠以最小的中斷進行非常好的管理。

  • Overall, across the portfolio, our ability to deploy digital technologies to look at real-time across all of our clinical trial sites, across our clinical trial portfolio is enabling us to intervene and to ensure that we minimize the disruption. Some of the highlights include a significant number of remote monitoring visits, which we're continuing to scale up and we also hope to use post pandemic as an ongoing normal course of business to increase the efficiency of our operations.

    總體而言,在整個產品組合中,我們部署數字技術以實時查看我們所有臨床試驗站點和臨床試驗產品組合的能力使我們能夠進行干預並確保我們將乾擾降到最低。其中一些亮點包括大量的遠程監控訪問,我們正在繼續擴大規模,我們還希望將大流行後的正常業務作為持續的正常業務流程,以提高我們的運營效率。

  • We have 2,500 users on our artificial intelligence-driven Sense platform to predict where the issues are, where there are issues in clinical trials and to intervene. And we're having a very rapid ability across the network to detect, evaluate and respond to any site-level issues.

    我們在人工智能驅動的 Sense 平台上有 2,500 名用戶來預測問題所在、臨床試驗中的問題所在並進行干預。我們在整個網絡中擁有非常快速的能力來檢測、評估和響應任何站點級別的問題。

  • Now moving to Slide 9. When you look at our approach to ensuring the well-being of our associates, we've tried to ensure job safety with no job-related losses to COVID-19. We've paused ongoing restructurings, provided additional leave and child care assistance. We have a range of employee well-being programs. And we're also looking to adapt, and have adapted, our ways of working with our field force, protecting our associates in the field and changing the way we look at incentive comp and schemes to ensure our associates are treated fairly. This is a critically important slide because I believe it's what enables us to really see the kind of operating performance we've seen in the first quarter and expect to see over the course of this year. We have very high engagement levels across our associate base.

    現在轉到幻燈片 9。當您查看我們確保員工福祉的方法時,我們已嘗試確保工作安全,不會因 COVID-19 造成與工作相關的損失。我們暫停了正在進行的重組,提供了額外的假期和托兒服務。我們有一系列員工福利計劃。我們也在尋求調整併已經調整我們與現場工作人員合作的方式,保護我們在現場的員工,並改變我們看待激勵補償和計劃的方式,以確保我們的員工得到公平對待。這是一張非常重要的幻燈片,因為我相信這使我們能夠真正看到我們在第一季度看到的那種運營業績,並期望在今年看到這種業績。我們在我們的員工基礎上擁有非常高的參與度。

  • Now moving to Slide 10. When you look at our engagement with HCPs and with patients, we've moved very quickly to look at digital solutions to enable patients to have online drug refills, access to disease education and access to direct-to-patient services. With respect to HCPs, we've scaled quickly on web meetings, WeChat and e-mail in China. We've provided a range of tools to our sales associates to be able to engage in real-time and are building additional portals to really try to be at the leading edge of how digital technologies can improve the ability to engage with customers.

    現在轉到幻燈片 10。當您查看我們與 HCP 和患者的互動時,我們已經非常迅速地研究了數字解決方案,以使患者能夠在線補充藥物、獲得疾病教育並獲得直接就診的機會服務。在 HCP 方面,我們在中國的網絡會議、微信和電子郵件方面迅速擴大了規模。我們為我們的銷售人員提供了一系列工具,以便他們能夠實時參與,並正在構建更多的門戶網站,以真正嘗試在數字技術如何提高與客戶互動的能力方面處於領先地位。

  • Now lastly, I wanted to turn to the important role we're playing in responding to the COVID-19 pandemic on Slides 11 and 12. First, starting on the left-hand side, you can see with our COVID-19 response funds and donations, we've committed $40 million to countries across the globe to really support local efforts and relief local efforts for health care systems to build resilience in the face of this challenging situation. We've also committed over 130 million doses of donated drugs with hydroxychloroquine, which are reaching now over 60 countries with 50 million doses shipped to date. And that's, of course, at the request of those -- of ministries of health. We're working on a range of external collaborations, the COVID Accelerator where, with Bill & Melinda Gates Foundation, I serve as the Co-Chair, and we're working very hard to accelerate the next-generation of treatments that we hope will come about from our collaborations as well as a range of other partnerships you see here.

    最後,在幻燈片 11 和 12 上,我想談談我們在應對 COVID-19 大流行方面發揮的重要作用。首先,從左側開始,您可以看到我們的 COVID-19 響應資金和捐款,我們已經向全球各國承諾了 4000 萬美元,以真正支持當地的努力和救濟當地醫療保健系統的努力,以在這一充滿挑戰的情況下建立復原力。我們還承諾捐贈超過 1.3 億劑含有羥氯喹的藥物,這些藥物現已到達 60 多個國家,迄今已運送 5000 萬劑。當然,這是應衛生部的要求。我們正在開展一系列外部合作,即 COVID Accelerator,我與 Bill & Melinda Gates Foundation 一起擔任聯合主席,我們正在努力加速我們希望的下一代治療來自我們的合作以及您在此處看到的一系列其他合作夥伴關係。

  • From an internal discovery standpoint, we've launched our own drug discovery efforts to try to find our own direct antivirals in collaboration with a number of academic and other collaborators. And Jay Bradner and the NIBR team are working hard to bring these efforts forward.

    從內部發現的角度來看,我們已經開展了自己的藥物發現工作,試圖與許多學術和其他合作者合作找到我們自己的直接抗病毒藥物。 Jay Bradner 和 NIBR 團隊正在努力推動這些努力。

  • And then lastly and importantly, we've engaged in our own clinical investigations with Novartis-sponsored studies and IITs. Going to Slide 12, just to briefly review some of those efforts, with respect to Novartis-sponsored Phase III studies, we have 3 Phase III studies now endorsed by the FDA at canakinumab, ruxolitinib and hydroxychloroquine. Of course, it's important to note that we have to be humble with respect to anytime we try to repurpose drugs in this kind of setting. And we've seen, of course, with the early IL-6 data, this will be a challenge. Nonetheless, we think it's critical that we focus now on generating double-blind, randomized, controlled, adequately powered studies to really figure out which of these interventions could help patients.

    最後也是最重要的一點,我們通過諾華贊助的研究和 IIT 開展了我們自己的臨床研究。轉到幻燈片 12,只是簡要回顧其中的一些努力,關於諾華贊助的 III 期研究,我們有 3 項 III 期研究現在得到 FDA 的認可,涉及 canakinumab、ruxolitinib 和羥氯喹。當然,重要的是要注意,無論何時我們試圖在這種環境中重新利用藥物,我們都必須保持謙虛。當然,我們已經看到,對於早期的 IL-6 數據,這將是一個挑戰。儘管如此,我們認為至關重要的是,我們現在必須專注於開展雙盲、隨機、對照、充分有力的研究,以真正弄清楚這些干預措施中的哪些可以幫助患者。

  • We've supported over 32 IIT proposals from a full range of our portfolio, ranging from drugs like secukinumab, Cosentyx as well as imatinib, valsartan and omalizumab Xolair.

    我們支持了超過 32 項來自我們全系列產品組合的 IIT 提案,包括 secukinumab、Cosentyx 以及伊馬替尼、纈沙坦和奧馬珠單抗 Xolair 等藥物。

  • And then lastly, with respect to access initiatives, we've approved now 697 individual requests and 23 from governments all around the world.

    最後,關於訪問計劃,我們現在已經批准了 697 個個人請求和來自世界各地政府的 23 個請求。

  • So Slide 13, thinking about now taking a step back on the dynamics we expect to see on the full year. I think one of the things -- the things we're watching very carefully are inpatient/physician dynamics. On the positive side, we see longer script lengths. We see higher rates of compliance to many of our medicines. But on the flip side, we have, I think, all seen the declines in visits to providers and hospitals over the course of recent weeks, particularly for us in certain therapeutic areas like ophthalmology. So we're watching those dynamics closely. We're optimistic that, given the desire of physicians and the health care community not to have the hidden cost of deferral of care for patients as well as these health care systems' own economic incentives to get their health care systems running appropriately again, we'll get to a balanced situation in the coming months.

    所以幻燈片 13,考慮現在退後一步,我們期望在全年看到的動態。我認為其中一件事——我們非常仔細地觀察的是住院病人/醫生的動態。從積極的方面來說,我們看到更長的腳本長度。我們看到我們的許多藥物的依從率更高。但另一方面,我認為,在最近幾週的過程中,我們都看到了對提供者和醫院的訪問量下降,尤其是在眼科等某些治療領域。所以我們正在密切關注這些動態。我們樂觀地認為,鑑於醫生和醫療保健界希望不承擔推遲患者護理的隱性成本,以及這些醫療保健系統自身的經濟激勵措施,以使他們的醫療保健系統再次正常運行,我們將在未來幾個月內達到平衡狀態。

  • Also, important payer and health care system dynamics. We're going to see, I think, over the course of the year, shifts in sources of reimbursement in the United States as patients shift their insurance to whether a government insurance and private insurance plans. In addition, in Europe, we may see some delays in reimbursement decisions based on where different health authorities decide to take things in the coming years. So those are dynamics we're watching. Hard to say exactly how it will play out, but important dynamics.

    此外,重要的付款人和醫療保健系統動態。我認為,在這一年中,隨著患者將保險轉向政府保險和私人保險計劃,我們將看到美國報銷來源的變化。此外,在歐洲,我們可能會看到報銷決定出現一些延遲,具體取決於未來幾年不同衛生當局決定採取的措施。所以這些是我們正在觀察的動態。很難確切地說它將如何發揮作用,但很重要的動力。

  • And then lastly, from a clinical trial/regulatory dynamic standpoint, FDA is working very hard based on all of our engagement to maintain clinical review time line. That is our current expectation. But of course, we need to watch those dynamics very closely as the year unfolds.

    最後,從臨床試驗/監管動態的角度來看,FDA 正在非常努力地基於我們所有的參與來維持臨床審查時間表。這是我們目前的期望。但當然,隨著這一年的展開,我們需要密切關注這些動態。

  • So that, I think, summarizes where we are on the pandemic. You can see with stable operations, trying to be a leader in respect to the global response to overcoming this situation and taking care of our associates, people and putting ourselves in the right place to have resilience for the long term.

    所以,我認為,總結了我們在大流行中所處的位置。您可以看到,通過穩定的運營,努力成為全球應對這種情況的領導者,並照顧我們的員工和員工,並將自己置於正確的位置以保持長期的複原力。

  • Now turning to our operational performance on Slide 14. You can see that, in the quarter, we had very strong growth across our key growth drivers. Highlights included, of course, Entresto, Zolgensma and Cosentyx, also with very solid performance. And then across the full range of oncology assets, again, you can see that our medicines are doing well across the key brands in Novartis.

    現在轉向我們在幻燈片 14 上的運營業績。您可以看到,在本季度,我們的主要增長驅動因素都實現了非常強勁的增長。亮點當然包括 Entresto、Zolgensma 和 Cosentyx,它們的表現也非常出色。然後在所有腫瘤學資產中,您可以再次看到我們的藥物在諾華的主要品牌中表現良好。

  • And on the right-hand side, now we've moved up to 46% of our total Innovative Medicine sales coming from key growth drivers and launches, demonstrating the rejuvenation in our portfolio for the mid- to long term.

    在右側,現在我們的創新藥物總銷售額的 46% 來自關鍵增長驅動因素和發布,這表明我們的產品組合在中長期內恢復了活力。

  • Now turning to Slide 15, a few words on Sandoz. Sandoz had an outstanding quarter, benefiting in part from COVID-19-related forward purchasing, but also very strong underlying performance with sales growth of 11% in constant currency. This was driven by a strong biosimilars performance with 31% constant currency growth as well as excellent performance in Europe with 19% constant currency growth.

    現在轉到幻燈片 15,談談 Sandoz。 Sandoz 的季度表現出色,部分受益於與 COVID-19 相關的遠期採購,但基礎業績也非常強勁,按固定匯率計算,銷售額增長了 11%。這是由強勁的生物仿製藥業績(以 31% 的固定匯率增長)以及在歐洲以 19% 的固定匯率增長的出色表現推動的。

  • Now with respect to the U.S. divestment of Aurobindo, we've mutually agreed, as we've announced, to terminate that transaction. And we'll be focused now on optimizing that U.S. business, and Harry will have some more comments as well on the overall size and dynamics of that portfolio.

    現在,關於 Aurobindo 在美國的撤資,我們已經相互同意,正如我們宣布的那樣,終止該交易。我們現在將專注於優化該美國業務,Harry 還將對該投資組合的整體規模和動態發表更多評論。

  • Now moving to Zolgensma on Slide 16. Our U.S. growth momentum continues. You saw, in the quarter, as we guided, our Q1 sales were in line with our Q4 2019 sales. The next catalyst for Zolgensma will certainly be the launches in Japan and Europe. And that's what's, I think, going to lead to the next sales ramp for this product. But in Q1, we also announced important data at MDA, which demonstrated the intravenous formulation had outstanding results, both for -- in terms of persistence out beyond 5 years as well as in asymptomatic patients meeting their WHO motor milestones. And we also announced in the quarter that FDA completed its review of its August 2019 Form 483 response with no further enforcement actions.

    現在轉到幻燈片 16 上的 Zolgensma。我們在美國的增長勢頭仍在繼續。正如我們所指導的那樣,您在本季度看到,我們的第一季度銷售額與我們 2019 年第四季度的銷售額一致。 Zolgensma 的下一個催化劑肯定是在日本和歐洲的上市。這就是我認為將導致該產品下一次銷售增長的原因。但在第一季度,我們還在 MDA 上公佈了重要數據,這表明靜脈注射製劑具有出色的效果,無論是在超過 5 年的持久性方面,還是在達到 WHO 運動里程碑的無症狀患者中。我們還在本季度宣布,FDA 完成了對 2019 年 8 月 483 表格回复的審查,沒有採取進一步的執法行動。

  • So upcoming milestones, CHMP positive opinion achieved and European Commission decision expected shortly; Japan reimbursement decision expected shortly. And I think, importantly and perhaps underestimated, the launches we'll have in a range of other countries around the world providing additional opportunities for growth.

    因此,即將到來的里程碑,CHMP 的積極意見得到實現,歐盟委員會的決定預計很快;日本的償付決定預計很快。而且我認為,重要的是,也許被低估了,我們將在世界其他一系列國家推出的產品為增長提供了額外的機會。

  • Now moving to Slide 17. With AVXS-101 IT, we believe, in the quarter, we also showed, with strong data, very compelling clinical profile using the gold standard Hammersmith score demonstrating a very robust response with a mean 6-point increase in Hammersmith, twice the clinical meaningful threshold, as well as 92% of patients in that study in the 2- to 5-year-old age group achieving a clinically meaningful response. So we're in the process now of working with FDA to resolve the clinical hold with the ongoing preclinical studies that we currently have initiated. We'll be meeting with FDA in the course of Q2 to clarify the scope of the data required and then moving to a pre-BLA meeting, where we hope to clarify then our ability to file a BLA for AVXS-101 IT.

    現在轉到幻燈片 17。對於 AVXS-101 IT,我們相信,在本季度,我們還展示了強大的數據,使用黃金標準 Hammersmith 評分非常引人注目的臨床概況,表明反應非常穩健,平均增加了 6 個百分點Hammersmith,臨床意義閾值的兩倍,以及該研究中 92% 的 2 至 5 歲年齡組患者實現了臨床意義的反應。因此,我們現在正在與 FDA 合作,通過我們目前啟動的正在進行的臨床前研究來解決臨床暫停問題。我們將在第二季度與 FDA 會面,以澄清所需數據的範圍,然後轉至 BLA 前會議,我們希望屆時澄清我們為 AVXS-101 IT 提交 BLA 的能力。

  • Now moving to Slide 18. For 2020, overall, our catalysts remain on track. You can see the full range of catalyst here. I look forward to continuing to provide you updates on the various approval submissions, readouts and Phase III starts.

    現在轉到幻燈片 18。總體而言,到 2020 年,我們的催化劑仍處於正軌。你可以在這裡看到全系列的催化劑。我期待繼續為您提供有關各種批准提交、讀數和第三階段啟動的最新信息。

  • So I think a very strong start to the year. You can see great operational performance, strong innovation performance and well prepared for the pandemic and showing resilience throughout the coming period.

    所以我認為今年的開局非常強勁。您可以看到出色的運營績效、強大的創新績效,並為大流行做好了充分的準備,並在未來一段時間內表現出韌性。

  • So with that, I'll hand it to Marie-France to give you some more details on the pharmaceuticals performance.

    因此,我將把它交給 Marie-France,為您提供有關藥物性能的更多詳細信息。

  • Marie-France Tschudin - President of Novartis Pharmaceuticals

    Marie-France Tschudin - President of Novartis Pharmaceuticals

  • Thank you, Vas. Q1 was a very solid start to the year for pharma, with strong underlying demand across the board, 14% growth. We did see impact of COVID-19, which was a net positive, and we do anticipate this to reverse later on in the year. The forward purchasing and stocking that we saw was mainly in Europe. And as you previously mentioned, Vas, the ophthalmology franchise was the most negatively impacted so far. We've seen some new patient starts starting to slow down across the portfolio. But having said that, we also made great progress in our innovation agenda during Q1.

    謝謝你,瓦斯。第一季度對製藥業來說是一個非常穩健的開端,整體需求強勁,增長了 14%。我們確實看到了 COVID-19 的影響,這是一個淨積極因素,我們確實預計這種情況會在今年晚些時候發生逆轉。我們看到的遠期採購和備貨主要在歐洲。正如你之前提到的,Vas,眼科專營權迄今為止受到的負面影響最大。我們已經看到一些新患者開始在整個投資組合中放緩。但話雖如此,我們在第一季度的創新議程上也取得了很大進展。

  • We passed regulatory milestones for Beovu, Mayzent, Cosentyx non-radiographic axial SpA, inclisiran and ofatumumab. Our launches are on track. And of course, we'll work closely with customers, authorities and health care systems to navigate some of the uncertainties related to the pandemic.

    我們通過了 Beovu、Mayzent、Cosentyx 非放射軸向 SpA、inclisiran 和 ofatumumab 的監管里程碑。我們的發射步入正軌。當然,我們將與客戶、當局和醫療保健系統密切合作,以應對與大流行相關的一些不確定性。

  • If we move to Cosentyx, our demand for Cosentyx continues to outperform the market in dermatology and rheumatology. We saw some stocking in Europe, very little in the U.S. And our first-line access strategy, which is our focus, is working. The majority of our growth is coming from first line, and this is 70% of the market.

    如果我們轉向 Cosentyx,我們對 Cosentyx 的需求將繼續優於皮膚病學和風濕病學市場。我們在歐洲看到了一些庫存,在美國則很少。我們的重點是一線准入戰略正在發揮作用。我們的大部分增長來自一線,這是市場的 70%。

  • We also continue to strengthen our value proposition. We're on track for non-radiographic axial SpA, which will be our fourth indication. We continue to release compelling data. And if you look at the example of ULTIMATE, it's the first large randomized ultrasound study in PsA, shows rapid impact of Cosentyx on joint inflammation. And this just reinforces our profile as a complete treatment in skin and joints.

    我們還繼續加強我們的價值主張。我們正在追踪非放射軸性 SpA,這將是我們的第四個適應症。我們繼續發布令人信服的數據。如果你看一下 ULTIMATE 的例子,它是 PsA 中第一個大型隨機超聲研究,顯示 Cosentyx 對關節炎症的快速影響。這只是加強了我們作為皮膚和關節全面治療的形象。

  • We've also just received the Chinese approval in AS. So we're very confident for the year. In the current environment, we expect that Cosentyx will continue to do well in repeat prescriptions. And physicians are asking their patients to stay on therapy. Cosentyx should also be the preferred choice for biologics once patients get back to the office, given its strong safety profile and the rapid regain of response after treatment interruption. We've got 5-year data. It's very compelling.

    我們也剛剛在 AS 中獲得了中國的批准。所以我們對今年很有信心。在當前環境下,我們預計 Cosentyx 將繼續在重複處方方面表現良好。醫生要求他們的病人繼續接受治療。一旦患者回到辦公室,Cosentyx 也應該是生物製劑的首選,因為它具有強大的安全性和治療中斷後反應的迅速恢復。我們有 5 年的數據。這是非常有說服力的。

  • With Entresto, we saw an impressive growth across the globe in Q1. We've reached a tipping point with Entresto, and it's truly seen as standard of care in the U.S. and Europe. We were seeing pre-COVID NBRxs at an all-time high of 4,500. And China also saw the fastest uptake of primary care to date, which speaks very highly to the unmet need and the strong product profile.

    借助 Entresto,我們在第一季度看到了全球範圍內令人印象深刻的增長。我們已經達到了 Entresto 的臨界點,它在美國和歐洲真正被視為護理標準。我們看到 COVID 之前的 NBRx 達到了 4,500 的歷史新高。迄今為止,中國的初級保健普及速度也是最快的,這充分說明了未滿足的需求和強大的產品形象。

  • We also expect to launch in Japan in the second half of the year, and we now have a strong local partner. We submitted pEF in the U.S. And our growth in Q1 was demand-driven with only a small boost from stocking. We obviously expect to see a COVID-related slowdown to new initiations in Q2, but the need for a product like Entresto that keeps patients out of hospital is now more important than ever.

    我們還預計下半年在日本推出,我們現在擁有強大的本地合作夥伴。我們在美國提交了 pEF。我們在第一季度的增長是由需求驅動的,庫存只有很小的推動作用。我們顯然希望在第二季度看到與 COVID 相關的新啟動放緩,但現在比以往任何時候都更需要像 Entresto 這樣讓患者遠離醫院的產品。

  • If we move to Beovu, Beovu was off to a very strong start, possibly one of our best launches ever. And now we've been impacted by the safety signal, it's confirmed and rare. There are 2 principles that are guiding us in what we're doing. The first is patient safety. And for us, this is paramount. And the second is transparency with the regulators, prescribers and all stakeholders. The initial investigation is being completed. The labels are being updated, and we are now working with retina experts to find out how to best understand and mitigate the safety concerns.

    如果我們搬到 Beovu,Beovu 的開端非常強勁,可能是我們有史以來最好的發布之一。現在我們受到了安全信號的影響,它得到了證實並且很少見。有 2 條原則在指導我們所做的事情。首先是患者安全。對我們來說,這是最重要的。第二個是監管者、處方者和所有利益相關者的透明度。初步調查正在完成。標籤正在更新,我們現在正在與視網膜專家合作,以找出如何最好地理解和減輕安全問題。

  • We see that retina specialists are really keen to help us, and this is a reflection of the efficacy they saw in the real world. We remain totally committed to Beovu as evidenced by our comprehensive Phase III clinical trial program. We now have approval in 9 markets outside the U.S. So for patients all over the world, our priority is to safely deliver the benefits that Beovu can provide.

    我們看到視網膜專家真的很想幫助我們,這反映了他們在現實世界中看到的效果。我們仍然完全致力於 Beovu,我們全面的 III 期臨床試驗計劃證明了這一點。我們現在在美國以外的 9 個市場獲得批准。因此,對於世界各地的患者,我們的首要任務是安全地提供 Beovu 可以提供的好處。

  • It's maybe worthwhile spending a little bit of time on the ophtha franchise because this is clearly the one that's most affected by COVID. We've seen clinic visits and prescription drop in March and April. And week by week, we saw those numbers coming down. It's clear that, in retina, we're talking about a very vulnerable patient population. And of course, these are physician-administered products. In addition, if we look at dry eye disease, which is not considered life-saving, we've seen a lot of cancellation of appointments and visits being delayed. It's hard to predict when things will get back to normal. However, it's also true that retina patients will need their treatments. So right now, our focus is to work with providers to find solutions to the capacity issues once patients start getting back to the centers.

    花一點時間在 ophtha 專營權上也許是值得的,因為這顯然是受 COVID 影響最大的一個。我們已經看到 3 月和 4 月的門診就診和處方下降。一周又一周,我們看到這些數字在下降。很明顯,在視網膜中,我們談論的是一個非常脆弱的患者群體。當然,這些是醫生管理的產品。此外,如果我們看看不能挽救生命的干眼病,我們會看到很多預約取消和就診被推遲。很難預測事情何時會恢復正常。然而,視網膜患者也確實需要接受治療。因此,現在,我們的重點是與提供者合作,在患者開始返回中心後找到容量問題的解決方案。

  • If we move to ofatumumab, we are very excited about the potential of ofatumumab. The opportunity to have a highly efficacious B-cell therapy for a broad population early and the impact that, that could have on disease progression could potentially change the way physicians are treating MS. So we are staying fully focused on bringing ofatumumab to market.

    如果我們轉向 ofatumumab,我們對 ofatumumab 的潛力感到非常興奮。早期為廣大人群提供高效 B 細胞療法的機會以及可能對疾病進展產生的影響可能會改變醫生治療 MS 的方式。因此,我們將完全專注於將 ofatumumab 推向市場。

  • Currently, we do not expect any regulatory delays. And from a launch standpoint, we're ready for whatever the situation is when we launch, whether we're seeing prescribers or other stakeholders face to face or virtually on a state-by-state basis. Now more than ever, bringing a B-cell therapy that's highly efficacious and administered at home is highly attractive. And our goal is that when patients come back, we'll make it easy for them to start on ofatumumab.

    目前,我們預計不會出現任何監管延誤。從發布的角度來看,我們已經為發佈時的任何情況做好了準備,無論我們是與開處方者或其他利益相關者面對面,還是實際上在逐個州的基礎上。現在比以往任何時候都更有吸引力的是,帶來一種高效且在家中進行的 B 細胞療法。我們的目標是,當患者回來時,我們會讓他們更容易地開始使用 ofatumumab。

  • Last but not least, inclisiran. We're moving full speed ahead towards launch. Our regulatory files have been accepted in both the U.S. and EU. We've published our data in the New England Journal of Medicine. We've completed our integration of The Medicines Company. Our teams are being recruited and trained. Our agreement with the NHS is progressing, and we're excited about this asset because it has the real potential to change CV mortality in a very broad patient population. We continue to expect U.S. approval in December.

    最後但同樣重要的是,inclisiran。我們正全速推進發射。我們的監管文件已被美國和歐盟接受。我們已經在《新英格蘭醫學雜誌》上發表了我們的數據。我們已經完成了對 The Medicines Company 的整合。我們的團隊正在被招募和培訓。我們與 NHS 的協議正在取得進展,我們對這項資產感到興奮,因為它具有改變非常廣泛的患者群體的 CV 死亡率的真正潛力。我們繼續預計美國會在 12 月獲得批准。

  • So overall, it's been a strong quarter. Clearly, this year, we will have challenges with COVID. But despite all of that, we will have strong growth across the portfolio, our growth drivers and our launches.

    所以總的來說,這是一個強勁的季度。顯然,今年,我們將面臨 COVID 挑戰。但儘管如此,我們將在產品組合、增長動力和發布方面實現強勁增長。

  • Over to Susanne.

    交給蘇珊。

  • Susanne Schaffert - President of Novartis Oncology

    Susanne Schaffert - President of Novartis Oncology

  • Thank you, Marie-France. Moving to Slide 28.

    謝謝你,瑪麗-法蘭西。轉到幻燈片 28。

  • So also for Oncology, we had a very strong quarter 1. We reached sales of $3.6 billion and delivered a strong growth of 12%. And we have seen very good momentum across our portfolio, mainly driven by excellent performance of our recent launches, Piqray and Adakveo, and continued double-digit growth of our growth drivers. Kisqali delivered 82% growth, making it the fastest-growing CDK 4/6 inhibitor in the quarter. And also, Revolade/Promacta and Tafinlar + Mekinist as well as Jakavi continued with very strong trajectory. These growth drivers more than compensated for the impact from generics entry of Afinitor and Exjade in the U.S. and Sandostatin LAR in Europe.

    同樣對於腫瘤學,我們在第一季度的表現非常強勁。我們的銷售額達到了 36 億美元,實現了 12% 的強勁增長。我們在我們的產品組合中看到了非常好的勢頭,主要是由於我們最近推出的 Piqray 和 Adakveo 的出色表現,以及我們的增長驅動因素持續兩位數的增長。 Kisqali 實現了 82% 的增長,使其成為本季度增長最快的 CDK 4/6 抑製劑。此外,Revolade/Promacta 和 Tafinlar + Mekinist 以及 Jakavi 繼續以非常強勁的軌跡發展。這些增長動力足以彌補 Afinitor 和 Exjade 在美國的仿製藥進入以及 Sandostatin LAR 在歐洲的影響。

  • From COVID-19 pandemic, we have seen some additional demand across our portfolio driven by forward purchasing, mainly across Europe, China and U.S. Obviously, these days, as care practitioners and patients are trying to minimize hospital and office visits, which will have potential impact on products that require hospital stay, like Kymriah and Lutathera. But overall, the oncology field is very resilient, and we remain very positive with the full year performance.

    從 COVID-19 大流行開始,我們的產品組合中出現了一些額外的需求,主要來自歐洲、中國和美國的遠期採購對需要住院的產品的影響,例如 Kymriah 和 Lutathera。但總體而言,腫瘤學領域非常有彈性,我們對全年的表現仍然非常樂觀。

  • Moving to the next slide. Piqray continued to perform very well with Q1 sales of $74 million. This is a first-in-class PIK3CA inhibitor indicated for 40% of HR+HER2- metastatic breast cancer patients with a PIK3CA mutation. The product had a great start in 2020 with expanded formulary policies coverage and continued Rx momentum in the U.S. We are expecting a continued uptake in PIK3CA testing, and our goal is to reach 40% by year-end 2020 and also anticipate the plasma test of Foundation Medicine to be approved by Q2 2020.

    轉到下一張幻燈片。 Piqray 繼續表現出色,第一季度銷售額為 7400 萬美元。這是一種一流的 PIK3CA 抑製劑,適用於 40% 的具有 PIK3CA 突變的 HR+HER2- 轉移性乳腺癌患者。該產品在 2020 年有一個良好的開端,擴大了處方政策的覆蓋範圍,並在美國繼續保持 Rx 勢頭我們預計 PIK3CA 測試將繼續被採用,我們的目標是到 2020 年底達到 40%,並預計基礎醫學將於 2020 年第二季度獲得批准。

  • Also this quarter, we have expanded geographical footprint ex U.S. with Piqray now being approved in 13 markets globally, including Switzerland, Canada and Australia, which is expected to drive additional growth from second half of 2020. We expect CHMP approval later this year. So overall, we are very -- progressing also with our very broad development program called EPIC. And we are very pleased to share with you that study protocols for the HER2+ advanced breast cancer indication, for triple-negative breast cancer, for ovarian cancer and for PROS has been aligned with the FDA.

    同樣在本季度,我們擴大了除美國以外的地理足跡,Piqray 目前已在全球 13 個市場獲得批准,包括瑞士、加拿大和澳大利亞,預計這將推動 2020 年下半年的額外增長。我們預計今年晚些時候 CHMP 將獲得批准。所以總的來說,我們非常 - 在我們非常廣泛的開發計劃(稱為 EPIC)方面取得了進展。我們很高興與您分享 HER2+ 晚期乳腺癌適應症、三陰性乳腺癌、卵巢癌和 PROS 的研究方案已與 FDA 保持一致。

  • Moving to the next slide. Our most recent launch, Adakveo, also had a very strong start, reaching $15 million of sales in Q1. Just to remind you, Adakveo is the only approved monthly therapy for the reduction of vaso-occlusive crises in sickle cell disease. In the U.S., there are more than 54,000 patients suffering from sickle cell disease and having more than 1 VOC per year. Therefore, a huge medical need.

    轉到下一張幻燈片。我們最近推出的 Adakveo 也有一個非常強勁的開端,第一季度的銷售額達到了 1500 萬美元。提醒您一下,Adakveo 是唯一獲批的用於減少鐮狀細胞病血管閉塞危機的月度療法。在美國,每年有超過 54,000 名患者患有鐮狀細胞病,且 VOC 含量超過 1。因此,醫療需求巨大。

  • Our focus was on access, and that is paying off with more than 320 accounts ordering Adakveo, including over half of the largest sickle cell disease centers. We have received positive feedback from hematologists and are very pleased to see a very high brand awareness. Already, 12 state Medicaid agencies from the top 23 high-prevalent states published their guidelines for Adakveo. We have received C code on April 1, and we expect to receive J code on July 1, which will further drive reimbursement confidence.

    我們的重點是訪問,這正在獲得回報,超過 320 個帳戶訂購了 Adakveo,其中包括超過一半的最大鐮狀細胞病中心。我們收到了來自血液學家的積極反饋,並且很高興看到非常高的品牌知名度。來自前 23 個高流行州的 12 個州醫療補助機構已經發布了他們的 Adakveo 指南。我們4月1日收到C碼,預計7月1日收到J碼,進一步提振報銷信心。

  • We continue to expand our global footprint with 2 ex U.S. approval and expect EMA decision in the second half of 2020. Clearly, as for all HCP-administered treatment, amidst COVID '19, we expect some delays in new starts as physicians are trying to avoid putting patients at risk of infection. But overall, we remain very positive for the full year performance of Adakveo.

    我們繼續擴大我們的全球足跡,獲得 2 個前美國批准,並預計 EMA 將在 2020 年下半年做出決定。顯然,對於所有 HCP 管理的治療,在 COVID '19 中,我們預計新的開始會出現一些延遲,因為醫生正試圖避免讓患者面臨感染風險。但總的來說,我們對 Adakveo 的全年表現仍然非常樂觀。

  • So with that, I will hand over to Harry.

    因此,我將移交給哈利。

  • Harry Kirsch - CFO

    Harry Kirsch - CFO

  • Thank you, Susanne. Good morning, and good afternoon, everybody. And as always, my comments refer to results of continuing operations and growth rates in constant currencies, unless otherwise noted.

    謝謝你,蘇珊。大家早上好,下午好。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 on Slide 32, this shows the summary of our quarter 1 continuing operations and performance. The table shows a very strong reported number -- set of numbers. And sales grew 13%, core operating income grew 34%. There were 2 main factors contributing to these results. Clearly and mainly, very strong underlying operational performance; and secondly, some COVID-19-related forward purchasing and lower spending. We estimate the favorable financial impact of COVID-19 in quarter 1 to be approximately $0.4 billion on sales and about the same on core operating income. Excluding these impacts, we estimate that sales would have grown 9% and core operating income would have grown 22%. Clearly, our quarter 1 operating income and sales performance was very strong; as anticipated, when we provided our full year guidance in January.

    所以在幻燈片 32 上,這顯示了我們第一季度持續運營和業績的摘要。該表顯示了一個非常強大的報告數字——一組數字。銷售額增長13%,核心營業收入增長34%。有兩個主要因素促成了這些結果。顯然,主要是非常強勁的潛在運營業績;其次,一些與 COVID-19 相關的遠期採購和較低的支出。我們估計 COVID-19 在第一季度對銷售額的有利財務影響約為 4 億美元,對核心營業收入的影響大致相同。排除這些影響,我們估計銷售額將增長 9%,核心營業收入將增長 22%。顯然,我們第一季度的營業收入和銷售業績非常強勁;正如預期的那樣,當我們在一月份提供全年指導時。

  • Net income growth was mainly impacted by higher legal provisions. Cash flow was also strong, increasing 8% in U.S. dollars to $2 billion, and I'll give a bit more detail later on in the presentation. We expect the COVID-19-related financial benefits in quarter 1 and in sales and core operating income to reverse later in the year.

    淨收入增長主要受到更高的法律規定的影響。現金流也很強勁,以美元計算增長了 8% 至 20 億美元,我將在稍後的演示文稿中提供更多細節。我們預計第一季度與 COVID-19 相關的財務收益以及銷售和核心營業收入將在今年晚些時候逆轉。

  • On Slide 33, you see the quarter 1 sales growth and core margins by division and for continuing operations. On the left side, you see sales and core margins as reported. On the right side, you see underlying sales and margins, excluding our estimated financial impacts from COVID-19 in quarter 1.

    在幻燈片 33 上,您可以看到按部門和持續運營劃分的第一季度銷售增長和核心利潤率。在左側,您可以看到報告的銷售額和核心利潤。在右側,您會看到潛在的銷售額和利潤率,不包括我們在第一季度受到 COVID-19 的估計財務影響。

  • I would like to focus on the underlying financial performance on the right side. So if we exclude there the COVID-19 impact, sales for quarter 1 have increased about 10% for Innovative Medicines, 7% for Sandoz and 9% for continuing operations. Continuing operations margins have improved by approximately 3 points to 32% of net sales. Our Innovative Medicines core margin has improved approximately 2 points to 35% of net sales. Sandoz, as Vas already mentioned, had a really outstanding quarter and significantly improved the underlying core margin by approximately 6% points to 25% of sales. Great work on productivity programs further improved the Sandoz gross margin and SG&A cost structures.

    我想關注右側的基本財務表現。因此,如果我們排除 COVID-19 的影響,創新藥物第一季度的銷售額增長了約 10%,山德士增長了 7%,持續運營增長了 9%。持續經營利潤率提高了約 3 個百分點,達到淨銷售額的 32%。我們的創新藥物核心利潤率提高了約 2 個百分點,達到淨銷售額的 35%。正如 Vas 已經提到的,山德士有一個非常出色的季度,並顯著提高了基本核心利潤率約 6 個百分點,達到銷售額的 25%。在生產力計劃方面的出色工作進一步改善了山德士的毛利率和 SG&A 成本結構。

  • Also, Sandoz's quarter 1 benefited from lower pricing impact and first-to-market launches in the U.S.

    此外,山德士第一季度受益於較低的定價影響和在美國的首次上市。

  • Slide 34 shows the dynamics of how we expect to bridge from the very strong reported quarter 1 numbers to the full year guidance. First, we expect the COVID-19 impact, as mentioned, to reverse later in the year. It's, of course, hard to say when exactly. It's probably a mix of quarter 2 and quarter 3. But also please keep in mind, $0.4 billion forward buying is in the end, only 2 shipping days for us, so unwinding could also fully happen in quarter 2.

    幻燈片 34 顯示了我們預計如何從非常強勁的第一季度報告數據到全年指導的動態。首先,如前所述,我們預計 COVID-19 的影響將在今年晚些時候逆轉。當然,確切的時間很難說。這可能是第 2 季度和第 3 季度的混合體。但也請記住,最終需要 4 億美元的遠期購買,對我們來說只有 2 個發貨日,因此平倉也可能在第 2 季度完全發生。

  • We also expect greater generic impacts mainly on Afinitor, Exjade and Travatan. In quarter 1, we have seen some effect of the respective generic impacts, but expect those to become bigger as the year progresses. Additionally, we will start lapping the Xiidra acquisition and a couple of other prior year launches in the second half. Lastly, we plan to increase launch and prelaunch investments for ofatumumab, capmatinib and inclisiran in the remainder of the year.

    我們還預計主要對 Afinitor、Exjade 和 Travatan 產生更大的一般影響。在第一季度,我們已經看到了各自的一般影響的一些影響,但預計隨著時間的推移,這些影響會變得更大。此外,我們將在下半年開始對 Xiidra 的收購和其他一些往年的發布進行研究。最後,我們計劃在今年剩餘時間內增加對 ofatumumab、capmatinib 和 inclisiran 的上市和上市前投資。

  • On Slide 34 -- 35, I want to share our key assumptions which we have based our full year guidance on. The prior guidance in January excluded the Sandoz U.S. oral solid and dermatology portfolio. As we are now retaining this portfolio, we expect both the growth on sales and growth of core operating income to be about 1% point lower than the guidance provided under the previous assumption. Of course, the base we grow from is also about $1 billion higher in 2019, exactly $1.074 billion, as we retain the business now.

    在幻燈片 34 - 35 上,我想分享我們基於全年指導的關鍵假設。 1 月份的先前指導不包括山德士美國口服固體和皮膚病學產品組合。由於我們現在保留這個投資組合,我們預計銷售增長和核心營業收入的增長將比之前假設提供的指導低約 1%。當然,我們的增長基礎在 2019 年也增加了約 10 億美元,正好是 10.74 億美元,因為我們現在保留了這項業務。

  • We continue to assume that no Gilenya and no Sandostatin LAR generics enter in 2020 in the U.S. Also, I'm sure you have seen this, we just got news of a positive Gilenya IPR appeal ruling. Of course, we closely monitor the District Court decision, and we'll let you know when we know more.

    我們繼續假設沒有 Gilenya 和 Sandostatin LAR 仿製藥進入 2020 年在美國。另外,我相信你已經看到了這一點,我們剛剛得到了 Gilenya IPR 上訴裁決的積極消息。當然,我們會密切關注地方法院的決定,當我們了解更多信息時會通知您。

  • Now to some rough assumption as it relates to COVID-19 impacts. Of course, nobody knows exactly what will happen over the next months and quarters. Here's what we have roughly assumed for our unchanged guidance.

    現在來做一些粗略的假設,因為它與 COVID-19 的影響有關。當然,沒有人確切知道未來幾個月和幾個季度會發生什麼。以下是我們對未更改指導的粗略假設。

  • We do include the forecast assumption that health care systems return to normal prescription and consumption dynamics during quarter 2 in our major markets. So not economies, but health care and prescribing. We assume that quarter 1 benefits of forward purchasing and lower spending reverse later in the year. Of course, we will closely monitor those business dynamics, and we'll update you also on the guidance, if needed, at quarter 2 earnings.

    我們確實包括了預測假設,即醫療保健系統在我們的主要市場第二季度恢復正常的處方和消費動態。所以不是經濟,而是醫療保健和處方。我們假設第一季度遠期採購和降低支出的好處在今年晚些時候發生逆轉。當然,我們將密切關注這些業務動態,如果需要,我們還將在第二季度收益時向您提供最新的指導。

  • With these assumptions, on Slide 36, we confirm our full year outlook, continuous operation sales expected to grow mid- to high single-digit and core operating income expected to grow ahead of sales and increasing the margin at high single to low double digit.

    有了這些假設,在幻燈片 36 上,我們確認了我們的全年展望,預計持續經營銷售額將增長中高個位數,核心營業收入預計將領先於銷售增長,並以高個位數至低兩位數增加利潤率。

  • For Innovative Medicines division, also unchanged. We expect sales to grow mid- to high single-digit and for Sandoz to grow low single-digit.

    對於創新藥物部門,也沒有變化。我們預計銷售額將增長中高個位數,而 Sandoz 將增長低個位數。

  • Let me add a few words on quarter 2 dynamics. Of course, quarterly growth rates are likely more volatile in this COVID-19 situation. For us, quarter 2 sales growth is likely to be low to mid-single digits. This mainly depends on how much COVID-19 forward buy of Q1 unwinds in Q2 and how sales of our ophtha portfolio is impacted by significantly lower physician visits, as Marie-France also has laid out.

    讓我就第 2 季度的動態添加幾句話。當然,在這種 COVID-19 情況下,季度增長率可能會更加波動。對我們來說,第二季度的銷售增長可能是低到中個位數。這主要取決於第一季度的 COVID-19 遠期購買在第二季度有多少平倉,以及我們的 ophtha 產品組合的銷售如何受到醫生就診次數顯著減少的影響,正如 Marie-France 所指出的那樣。

  • On the bottom line, please remember that, in quarter 2 of 2019, we had roughly $0.1 billion benefit from prelaunch inventory provision releases, mainly for Zolgensma -- upon Zolgensma approval. This is, of course, considered in our full year 2020 guidance, but please include this also in your quarter 2 core operating income modeling.

    歸根結底,請記住,在 Zolgensma 批准後,在 2019 年第二季度,我們主要從 Zolgensma 的發布前庫存準備金釋放中獲得了大約 1 億美元的收益。當然,這已在我們的 2020 年全年指導中考慮,但也請在您的第二季度核心營業收入模型中包括這一點。

  • On Page 37, just a quick word on cash flow. Of course, cash flow remains very important for us, particularly in view of the current situation. And you see here strong cash flow growing 8%, mainly driven by higher operating income. We do have higher working capital in the quarter, mainly impacted by higher accounts receivables as the forward purchasing mostly happened in March. But no worries here. We are absolutely on track to collect that. And that's also what we see overall. Our cash collections remain very strong. It's, of course, a big focus of the organizations. And days sales outstanding remain totally in line with year-end 2019, so very good cash collection discipline and cash flows.

    在第 37 頁,簡單介紹一下現金流。當然,現金流對我們來說仍然非常重要,特別是考慮到目前的情況。你在這裡看到強勁的現金流增長了 8%,主要是由於更高的營業收入。我們在本季度確實有較高的營運資金,主要受應收賬款增加的影響,因為遠期採購主要發生在 3 月份。但這裡不用擔心。我們絕對會收集到這些。這也是我們整體看到的。我們的現金收款仍然非常強勁。當然,這是組織的一大重點。天數銷售額與 2019 年底完全一致,因此現金收款紀律和現金流非常好。

  • Finally, on Slide 38, I want to bring to your attention the significant change in the estimated currency impact on our results. Since last time we spoke 3 months ago, we do update each month, but maybe not everyone looks at the website every month. And it's, of course, the result of the dollar -- U.S. dollar strengthening versus most other currencies. So if late April rates prevail for the remainder of 2020, the full year impact of currencies on sales would be negative 3% points and on core operating income negative 6% points. For quarter 2, it would be negative 4% and negative 7% respectively. And again, as a reminder, we do update this monthly in our website. I do recommend that you look at it, not only business situations or the currencies, of course, are volatile and it's worthwhile watching.

    最後,在幻燈片 38 上,我想提請您注意估計貨幣對我們結果的影響的重大變化。自從我們 3 個月前上次談話以來,我們每個月都會更新,但也許不是每個人每個月都會查看該網站。當然,這是美元的結果——美元兌大多數其他貨幣走強。因此,如果 4 月底的利率在 2020 年剩餘時間內占主導地位,那麼全年貨幣對銷售額的影響將為負 3%,對核心營業收入的影響為負 6%。第 2 季度將分別為負 4% 和負 7%。再次提醒一下,我們確實會在我們的網站上每月更新一次。我確實建議您查看它,不僅是商業情況或貨幣,當然,它是不穩定的,值得關注。

  • So with that, I'll turn it back to Vas.

    因此,我將把它轉回 Vas。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Great. Thank you.

    偉大的。謝謝你。

  • (technical difficulty)

    (技術難度)

  • In Q1, and we're maintaining our full year outlook, as Harry has nicely outlined. So we remain excited for the future, optimistic about 2020, and we look forward to taking your questions.

    正如哈利很好地概述的那樣,在第一季度,我們將維持全年展望。因此,我們仍然對未來感到興奮,對 2020 年持樂觀態度,我們期待著回答您的問題。

  • So with that, operator, we can open the line.

    因此,操作員,我們可以打開線路。

  • Operator

    Operator

  • Our first question comes from the line of Keyur Parekh.

    我們的第一個問題來自 Keyur Parekh。

  • Keyur Parekh - Equity Analyst

    Keyur Parekh - Equity Analyst

  • Two, please, if I may. One, Vas, for you. From a big-picture perspective, would love your thoughts on how you see the current pandemic impacting the way you were doing business in the longer term. How do you think the value of the broader health care system kind of within the health care system changes? And what do you think kind of young new CEOs like you can do to make the industry at a better place given previous public perception of the industry? That's kind of question #1.

    兩個,請,如果可以的話。一,瓦斯,給你。從大局的角度來看,您會喜歡您對當前大流行如何影響您長期開展業務的方式的看法。您如何看待醫療保健系統中更廣泛的醫療保健系統的價值變化?鑑於以前公眾對該行業的看法,您認為像您這樣的年輕新任 CEO 可以做些什麼來使該行業處於更好的位置?這是第一個問題。

  • And then question #2, for Marie-France. Kind of given the new findings on Beovu, would love to hear your views on where you think Beovu should be used if there's a patient subset where you think this might be better fitted? Or do you still see this as a broad therapy across the entire patient population base? How should we think about the peak sales opportunity for Beovu today?

    然後是 Marie-France 的問題 #2。考慮到 Beovu 的新發現,如果有患者子集您認為可能更適合 Beovu,您是否希望聽到您認為應該在哪裡使用 Beovu 的意見?還是您仍將其視為針對整個患者群體的廣泛療法?我們應該如何看待 Beovu 今天的銷售高峰機會?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thank you, Keyur. So first, I'll divide my comments into big-picture comments for the sector or the industry and then some specific comments on new ways of working, I think, will reshape how we think about running our company in the years ahead. First, this is, I think, a remarkable perhaps once-in-a-generation for a company -- company's opportunity to reset our reputation in the broader public mind. When you look today, we're in a moment in time where our industry, combined with the work of academia and the broader ecosystem, has stepped up to make unprecedented, I think, collaborations with over 170 now drug candidates somewhere in the clinic or in preclinical testing, over 90 vaccine candidates, well over 500 clinical trials now running massive efforts to do this in a nonprofit or donation basis to really lead the charge in trying to overcome this pandemic. And I think what that's leading to is, you see already in survey data, a shift in the perception of the value of this sector.

    謝謝你,凱爾。因此,首先,我將把我的評論劃分為對行業或行業的宏觀評論,然後對新的工作方式提出一些具體的評論,我認為,這將重塑我們對未來幾年經營公司的看法。首先,我認為,對於一家公司來說,這可能是千載難逢的一次——公司有機會在更廣泛的公眾心目中重新樹立我們的聲譽。當你今天看時,我們正處於一個時刻,我們的行業,結合學術界和更廣泛的生態系統的工作,已經加緊與臨床某處的 170 多個現在的候選藥物進行前所未有的合作或在臨床前測試中,超過 90 種候選疫苗、超過 500 項臨床試驗正在以非營利或捐贈的方式進行大規模努力,以真正帶頭努力克服這一流行病。而且我認為這導致的是,您已經在調查數據中看到,對該行業價值的看法發生了轉變。

  • I hope we can seize this moment to remind the world that this industry is why we've seen such remarkable -- part of the reason, at least, why we've seen such remarkable gains in life expectancy over the last 100 years. It's why we're able to withstand pandemics of the past and we'll be ultimately able to withstand this pandemic. So I think it's a remarkable opportunity to reset our reputation as an industry. And also, I think, for Novartis, part of the reason we took the time to walk you through all the things we're doing is we take it as a significant opportunity to make a major contribution around the world and also completely reposition ourselves as a company that's truly trying to be valued, maybe most valued by society.

    我希望我們能抓住這一刻來提醒世界,這個行業是我們看到如此顯著的原因——至少部分原因是我們在過去 100 年中看到預期壽命如此顯著的增長。這就是為什麼我們能夠抵禦過去的流行病,我們最終將能夠抵禦這種流行病。所以我認為這是一個重塑我們作為一個行業聲譽的絕佳機會。而且,我認為,對於諾華來說,我們花時間向您介紹我們正在做的所有事情的部分原因是,我們將其視為在世界範圍內做出重大貢獻的重要機會,並將自己完全重新定位為一家真正努力被重視的公司,也許是最受社會重視的公司。

  • And specifically, I think 3 things will shift health care systems. I think the rise of telemedicine, the rise of digital technologies, all the physicians we talk to clearly are seeing a big shift in how they engage with patients. Alongside that, of course, we're going to have a short-term impact of the shifts because of unemployment. But longer term, I believe that the digital technologies have now really taken hold in health care systems. And then on the same side, within our company, digital technologies and how we run our sales force, manufacturing lines, our R&D operations, have now also been forced to go to scale. I mean all of our AI and data science efforts are now being taken to scale simply because we have no choice.

    具體來說,我認為三件事將改變醫療保健系統。我認為遠程醫療的興起,數字技術的興起,我們與之交談的所有醫生都清楚地看到了他們與患者互動的方式發生了巨大轉變。當然,除此之外,我們還會因為失業而受到這些轉變的短期影響。但從長遠來看,我相信數字技術現在已經真正在醫療保健系統中佔據一席之地。然後在同一方面,在我們公司內部,數字技術以及我們如何運行我們的銷售隊伍、生產線、我們的研發業務,現在也被迫擴大規模。我的意思是,我們所有的人工智能和數據科學工作現在都在規模化,僅僅是因為我們別無選擇。

  • And that, I think, will ultimately lead to more distributed ways of working across large companies, which if companies can embrace distributed ways of working shift from just taking office space work and moving it into an auto office setting, but really rethink how we work, you could see dramatic increases in productivity, margin -- further margin expansions and, hopefully, a better output and innovation from our company longer term. So that's just some brief perspectives.

    而且,我認為,這最終將導致大公司採用更分佈式的工作方式,如果公司能夠採用分佈式工作方式,從僅僅使用辦公空間工作並將其轉移到汽車辦公環境中,但真正重新思考我們的工作方式,您可以看到生產力和利潤率的顯著提高——進一步擴大利潤率,並有望從我們公司長期獲得更好的產出和創新。所以這只是一些簡短的觀點。

  • Marie-France, on Beovu.

    Marie-France,關於 Beovu。

  • Marie-France Tschudin - President of Novartis Pharmaceuticals

    Marie-France Tschudin - President of Novartis Pharmaceuticals

  • So as you have noted, Beovu is off to an incredible start in our launch, and we still believe that this product will be a blockbuster. Of course, safety does come first, and we have a signal, it's rare, but the benefit/risk profile for the product remains positive. We have to understand the root cause. This may take some time. But we also have a long exclusivity in the U.S. and EU, and so we will play the long game on this one. What we're seeing in the marketplace from physicians is that physicians are in 2 camps. They're either pausing and waiting to understand more or they're actually taking a more cautious approach with their patients. We see approximately half the centers continue to order. Of course, now with the COVID situation, it's hard to say what is impacting what, but we are -- I think the fundamental point is that we're committed to resolving this issue. We have approval across 10 markets. And as we launch this product across the world, we will learn also about different treatment practices and how these have an impact on outcomes.

    正如您所指出的,Beovu 在我們的發布中取得了令人難以置信的開端,我們仍然相信該產品將成為重磅炸彈。當然,安全確實是第一位的,我們有一個信號,這種情況很少見,但該產品的收益/風險狀況仍然是積極的。我們必須了解根本原因。這可能要花點時間。但是我們在美國和歐盟也有長期的排他性,所以我們將在這個方面進行長期的比賽。我們從醫生那裡看到的是,醫生分為兩個陣營。他們要么暫停並等待了解更多信息,要么實際上對患者採取更謹慎的態度。我們看到大約一半的中心繼續訂購。當然,現在在 COVID 的情況下,很難說是什麼影響了什麼,但我們是——我認為基本點是我們致力於解決這個問題。我們在 10 個市場獲得批准。隨著我們在全球推出該產品,我們還將了解不同的治療方法以及這些方法對結果的影響。

  • Operator

    Operator

  • Our next question comes from the line of Graham Parry from Bank of America.

    我們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, you expressed confidence in meeting your PDUFA date on ofatumumab. But I think at your last update, you said the FDA hadn't inspected the manufacturing site in Stein yet, and that is obviously, an international inspection, which they had to at least temporarily shut down. So do you have a date for that inspection? Or has it already happened? Perhaps an update on your confidence in achieving that prior to the PDUFA date.

    因此,首先,您表示有信心在 ofatumumab 上滿足您的 PDUFA 日期。但我認為在您上次更新時,您說 FDA 尚未檢查 Stein 的生產基地,這顯然是一次國際檢查,他們至少不得不暫時關閉。那你有檢查的日期嗎?還是已經發生了?也許是關於您在 PDUFA 日期之前實現這一目標的信心的更新。

  • And then secondly, when you talk about the $400 million COVID benefit to sales and EBIT, is that just purely an inventory calculation? And have you also included in there the impact of the surge in prescriptions for chronic therapies like Entresto and Cosentyx as people rush to get their prescriptions filled?

    其次,當您談到 4 億美元的 COVID 對銷售和 EBIT 的好處時,這僅僅是庫存計算嗎?你是否也將 Entresto 和 Cosentyx 等慢性治療處方激增的影響包括在內,因為人們急於開處方?

  • And also, in your full year guidance, to what extent have you factored in the reduction we're seeing in new-to-brand on those drugs and the lack of new patient starts? Or are you just thinking these are getting warehoused and you should see them actually pick up with a new surge in end of Q2, Q3 as patient visits start to return?

    此外,在您的全年指導中,您在多大程度上考慮了我們在這些藥物的新品牌中看到的減少以及缺乏新患者的開始?或者您是否只是認為這些正在入庫,隨著患者就診開始返回,您應該看到它們實際上在第二季度末、第三季度末出現新的激增?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • So thanks, Graham. So I'll make a general comment on our engagement with FDA as an industry, and then John can comment specifically on ofatumumab. And we've had -- and I shared the FDA BRC for the pharma industry organization. In all our interactions with FDA, FDA has stayed committed to their view that they can meet their PDUFA time lines, and they will be using technology, virtual inspections, paper inspections, et cetera, to do their best to meet their PDUFA time lines. And in particular, when they look at prioritizing, priority reviews would, of course, be the ones they want to ensure they hit their time lines on. And it's worth noting that ofatumumab has a priority review with the priority review voucher. And John, specifically on ofa.

    所以謝謝,格雷厄姆。因此,我將對我們與 FDA 作為一個行業的合作發表一般性評論,然後約翰可以具體評論 ofatumumab。我們已經 - 我為製藥行業組織分享了 FDA BRC。在我們與 FDA 的所有互動中,FDA 一直致力於他們能夠滿足其 PDUFA 時間線的觀點,他們將使用技術、虛擬檢查、紙質檢查等,盡最大努力滿足其 PDUFA 時間線。特別是,當他們考慮優先級時,優先審查當然是他們想要確保他們按時完成的審查。並且值得注意的是,ofatumumab有優先審評憑證。還有約翰,特別是在ofa上。

  • John Tsai - Head of Global Drug Development & Chief Medical Officer

    John Tsai - Head of Global Drug Development & Chief Medical Officer

  • Yes. Thanks, Graham. Specific to ofatumumab, we've had good discussions with the regulatory agency, FDA specifically. In terms of inspections, as you noted, we had a clinical trial site inspection in the U.S. very recently, and that went very well. In terms of the manufacturing inspection, the manufacturing site is in Switzerland, and we had that site inspected about a year ago. And that went well. Now as Vas said, that sometimes they're granting waivers or asking other agencies to do the inspection. And we've not heard anything else in terms of the current inspection. But the most recent inspection that occurred a year ago was -- went very well.

    是的。謝謝,格雷厄姆。具體到ofatumumab,我們已經與監管機構進行了很好的討論,特別是FDA。在檢查方面,正如您所說,我們最近在美國進行了臨床試驗現場檢查,進展順利。在製造檢查方面,製造地點在瑞士,我們大約一年前檢查了那個地點。這很順利。現在正如 Vas 所說,有時他們會給予豁免或要求其他機構進行檢查。就目前的檢查而言,我們還沒有聽到任何其他消息。但一年前發生的最近一次檢查是——進行得非常順利。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • And then, Harry, on the guidance on the $400 million?

    然後,哈利,關於 4 億美元的指導意見?

  • Harry Kirsch - CFO

    Harry Kirsch - CFO

  • Yes. Thank you, Graham. So the $400 million, roughly, right? It's never easy to approximate these, but that's why we did it at company level as well as a division level, but not further down, easier to triangulate at a higher level. And the $0.4 billion is very little actually at the wholesalers. So we actually also held back orders where we felt they just would fill the wholesaler pipelines. And in good discussions with our customers, we reassured them that our supply chains are extremely robust and customer service levels are at normal record high. So most of this effect, we see longer scripts and basically maybe patients filling early or getting longer scripts, depends on the country and the payer allowing that. It is only 2 days on average, but it's majorly at the patient level, not so much at the wholesaler level.

    是的。謝謝你,格雷厄姆。所以大約4億美元,對吧?近似這些從來都不是一件容易的事,但這就是為什麼我們在公司級別和部門級別都這樣做,但不是更進一步,更容易在更高級別進行三角測量。而這 4 億美元實際上對批發商來說很少。因此,我們實際上還推遲了我們認為它們只會填滿批發商管道的訂單。在與客戶的良好討論中,我們向他們保證,我們的供應鏈非常穩健,客戶服務水平處於正常的歷史最高水平。所以大部分這種影響,我們看到更長的腳本,基本上可能是患者提前填寫或獲得更長的腳本,這取決於國家和允許這樣做的付款人。平均只有 2 天,但主要是在患者層面,而不是在批發商層面。

  • And so we do expect that this unwinds. On the other hand, could have a positive effect on more adherence to chronic medicines. And so that's a positive. On the other hand, of course, depending on the therapeutic areas, we also expect -- and that's also needed for the full year guidance, that systems return back to normal physician visits. That's certainly on new patient starts, in the launch area. And then on the other hand, of course, in ophthalmology where injections are necessary. And there we see, in April, a bigger impact. You don't see it yet so much in Q1, and that's also where we need this assumption that the systems start back up. Vas mentioned that there's a big urge and also health care systems looking at the unintended consequences of COVID, which means other diseases may be neglected.

    因此,我們確實希望這會得到緩解。另一方面,可能對更多地堅持慢性藥物產生積極影響。所以這是積極的。另一方面,當然,根據治療領域,我們也期望——這也是全年指導所需要的,系統恢復到正常的醫生就診。這肯定是在新病人開始時,在發射區。另一方面,當然,在需要注射的眼科領域。我們在 4 月看到了更大的影響。您在第一季度還沒有看到這麼多,這也是我們需要假設系統啟動備份的地方。 Vas 提到,有一個很大的衝動,而且衛生保健系統也在關注 COVID 的意外後果,這意味著其他疾病可能會被忽視。

  • Operator

    Operator

  • Next question comes from the line of Steve Scala.

    下一個問題來自 Steve Scala。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • I have two questions. First, why didn't Cosentyx appear to benefit from forward buying and it even fell a bit short of your guidance provided on the Q4 call? And then secondly, one theory for Beovu safety issues is a contaminant or impurity in the formulation. I'm curious, was the delay in filing Beovu several years ago due to the need to purify the formulation? I don't recall the company ever actually being specific on why the filing was delayed.

    我有兩個問題。首先,為什麼 Cosentyx 似乎沒有從遠期購買中受益,甚至比你在第四季度電話會議上提供的指導還差一點?其次,關於 Beovu 安全問題的一種理論是配方中的污染物或雜質。我很好奇,幾年前提交 Beovu 是因為需要純化配方嗎?我不記得該公司實際上曾具體說明提交文件延遲的原因。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thanks, Steve. On Cosentyx, Marie-France?

    謝謝,史蒂夫。在 Cosentyx,Marie-France?

  • Marie-France Tschudin - President of Novartis Pharmaceuticals

    Marie-France Tschudin - President of Novartis Pharmaceuticals

  • So as we mentioned before, there's a very strong performance across the board both the derm and rheum markets. We did see some small stocking, but it was mostly in Europe. There was no stocking in the U.S. It was very demand-driven results. We did see, obviously, Q1 seasonality around the reverification and our further strengthening of our first-line access strategy. But we continue to grow and be strong. And clearly, we do anticipate a COVID effect on our NBRxs. But we have a very solid TRx base, strong market share, so we're confident on our trajectory.

    因此,正如我們之前提到的,真皮和大黃市場的整體表現非常強勁。我們確實看到了一些小庫存,但主要是在歐洲。美國沒有庫存,這是非常受需求驅動的結果。顯然,我們確實看到了第一季度圍繞重新驗證的季節性以及我們進一步加強了我們的一線訪問策略。但我們會繼續成長並變得強大。顯然,我們確實預計 COVID 會對我們的 NBRx 產生影響。但我們擁有非常穩固的 TRx 基礎和強大的市場份額,因此我們對自己的發展軌跡充滿信心。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • And I'd just say on Cosentyx, we're confident that this brand will continue on its trend to exceed $5 billion. And so we're very confident in where Cosentyx is heading. These small variations quarter-to-quarter that get so scrutinized, I think, miss the bigger picture that this is a brand that's on its way to 9 indications, that has an outstanding market share position across its various therapeutic areas and a very unique positioning in rheumatology. So it's important to take a step back, I think, for our investors and not always focus on these small variances on the quarter.

    我只想在 Cosentyx 上說,我們有信心這個品牌將繼續保持超過 50 億美元的趨勢。因此,我們對 Cosentyx 的發展方向非常有信心。我認為,這些經過仔細審查的季度間的小變化錯過了更大的圖景,即這是一個正在走向 9 個適應症的品牌,在其各個治療領域擁有出色的市場份額地位和非常獨特的定位在風濕病學中。因此,我認為,對於我們的投資者來說,退後一步很重要,而不是總是關注本季度的這些小差異。

  • Now with respect to Beovu, just to remind everyone, we -- this is a history to see you've got a good memory, if you go back in time, we -- the original Phase III program took into Phase III the Phase I/II formulation. And then after Phase III, we did bridging study to final marketing image that ultimately went into the market. So we are doing a very detailed technical analysis just to understand was there anything that happened in that process. We have not identified anything to date that would be causative. But nonetheless, we are very carefully assessing that to fully understand that. These are very rare events. I mean if you look at these numbers, we're talking about 1 to 2 cases per 10,000. So this is not easy to find causative relationships. The other nuance to note is in -- outside the U.S., we've launched in a prefilled syringe. In the U.S., we launched in a vial. How that might impact the dynamic, we think, is something as well we'll have to watch.

    現在關於 Beovu,只是為了提醒大家,我們 -- 這是一段歷史,看你有一個很好的記憶,如果你回到過去,我們 -- 最初的第三階段計劃進入第三階段第一階段/II 配方。然後在第三階段之後,我們對最終進入市場的最終營銷形象進行了橋接研究。因此,我們正在進行非常詳細的技術分析,以了解在該過程中是否發生了任何事情。迄今為止,我們還沒有發現任何會引起疾病的東西。但儘管如此,我們正在非常仔細地評估這一點,以充分理解這一點。這些都是非常罕見的事件。我的意思是,如果你看看這些數字,我們說的是每 10,000 人中有 1 到 2 例。所以這並不容易找到因果關係。另一個需要注意的細微差別是在美國以外的地方,我們已經推出了預裝注射器。在美國,我們以小瓶的形式推出。我們認為,這將如何影響動態,也是我們必須關注的事情。

  • Operator

    Operator

  • Next question comes from the line of Peter Welford from Jefferies.

    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

  • I've got 2, please. Firstly, just on the cost base, I wonder if you could just comment perhaps on how we should think about COVID-19 potentially impacting that. Obviously, significant efforts by you, both on supplying drugs like hydroxychloroquine as well as obviously investing in new studies and perhaps also having to increase costs on existing studies to keep them going. But at the same time, obviously, like us, travel budget is significantly down. I wonder if you could just -- you could sort of talk us through the varying dynamics there we should think about for cost this year.

    我有2個,拜託。首先,僅在成本基礎上,我想知道您是否可以評論一下我們應該如何看待 COVID-19 可能對其產生影響。顯然,您付出了巨大的努力,無論是在提供羥氯喹等藥物方面,還是在顯然投資於新研究方面,也許還必須增加現有研究的成本以使它們繼續進行。但與此同時,很明顯,像我們一樣,旅行預算顯著下降。我想知道你是否可以 - 你可以通過我們今年應該考慮的不同動態來談談我們的成本。

  • And then secondly, just on marketing. I guess with all the efforts now that have gone into digital marketing and some of the significant changes that have been there starting in China and now other major markets, have you got any data so far in-house that can point to how effective that digital marketing is or could be? And how could this potentially shape your thinking in the future? Or do you think things will largely return to normal once the COVID situation finishes?

    其次,就營銷而言。我想,隨著現在數字營銷的所有努力以及從中國和其他主要市場開始的一些重大變化,到目前為止,您是否有任何內部數據可以表明數字營銷的有效性營銷是或可能是?這將如何影響您未來的想法?還是您認為一旦 COVID 情況結束,情況會基本恢復正常?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • So Harry, on the cost base?

    那麼哈利,在成本基礎上?

  • Harry Kirsch - CFO

    Harry Kirsch - CFO

  • Yes. Thank you, Peter. So on the cost base, as you have seen in quarter 1, it's roughly, right, I mean, $400 million top line, $400 million bottom line. We have a little over 20% cost of goods. So that's roughly $80 million of the cost base. And that's basically effect of 2 weeks. So you can imagine that there's never a formula, don't now take the $80 million times how many weeks. But there's quite some variable spend. That, of course, has to do with what is the possibility, how much is working from home, how much are the lockdown procedures basically also impacting the cost base in a positive way it would, right? Of course, we rather don't have it and have the top line be extremely dynamic. But there is clearly quite a potential, which is partly a natural hedge for some of the top line, if there would be a slowdown.

    是的。謝謝你,彼得。所以在成本基礎上,正如你在第一季度看到的那樣,它大致是,正確的,我的意思是,4 億美元的頂線,4 億美元的底線。我們的商品成本略高於 20%。因此,這大約是成本基礎的 8000 萬美元。這基本上是2週的效果。所以你可以想像,從來沒有一個公式,現在不要把 8000 萬美元乘以多少週。但是有相當多的可變支出。當然,這與可能性有關,有多少在家工作,多少鎖定程序基本上也會以積極的方式影響成本基礎,對吧?當然,我們寧願沒有它,而是讓頂線非常動態。但顯然存在相當大的潛力,如果出現放緩,這在一定程度上是對某些收入的自然對沖。

  • And then in the overall scheme of things, of course, we do a lot as a company, but it's not so material in terms of $50 billion company roughly, right, and our significant amount of profit and cash flow. So we are in a range that is manageable within our forecast. And we also make very good progress, slightly even ahead of target on our productivity efforts. So what -- I would not see that our COVID-related efforts would hinder us from margin progression or would then to truly blame. More important is to see how is the top line developing and are health care systems for the areas, therapeutic areas, that point to us starting to work normal again as we go through quarter 2.

    然後在整體方案中,當然,作為一家公司,我們做了很多事情,但就大約 500 億美元的公司而言,這並不是那麼重要,對,以及我們大量的利潤和現金流。因此,我們處於預測範圍內可管理的範圍內。而且我們也取得了非常好的進展,甚至比我們的生產力目標略超前。那又怎樣——我認為我們與 COVID 相關的努力不會阻礙我們的利潤增長,或者會因此而真正受到指責。更重要的是看看頂線是如何發展的,以及這些領域的醫療保健系統,治療領域,這表明我們在進入第二季度時開始再次正常工作。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • And then Marie-France, on digital marketing?

    然後是 Marie-France,談數字營銷?

  • Marie-France Tschudin - President of Novartis Pharmaceuticals

    Marie-France Tschudin - President of Novartis Pharmaceuticals

  • Yes. So we've clearly had to pivot very quickly to a very, very different way of working. And we've seen some remarkable initiatives across the globe. We've been able, for example, in China to reach 900,000 HCPs through WeChat and web-triggered e-mails. We've seen in the U.S. 1,500% increase in telemedicine. And so clearly, digital is going to take a new role in the future if we think about online drug refills, education, direct-to-patient and, of course, how we can enhance our face-to-face interactions with physicians.

    是的。因此,我們顯然必須非常迅速地轉向一種非常非常不同的工作方式。我們已經在全球範圍內看到了一些非凡的舉措。例如,我們已經能夠在中國通過微信和網絡觸發的電子郵件聯繫到 900,000 名 HCP。我們已經看到美國的遠程醫療增長了 1,500%。很明顯,如果我們考慮在線藥物補充、教育、直接面向患者,當然還有我們如何加強與醫生的面對面互動,數字化將在未來扮演新角色。

  • So one of the clear opportunities that we see is really in this stage is to understand what physicians prefer, what the markets prefer and then really clearly understand what are the most effective tactics that we have out there. The goal is to really just increase our effectiveness or our productivity in the marketplace, the efficiencies of the system, such as diagnosis and maybe adherence. And clearly, we're seeing opportunities also on how quickly we can bring products to market. So we've seen, for example, in the case of Xolair, home delivery being accelerated across different markets. So yes, there are some challenges, but there are clearly opportunities for us in the future.

    因此,我們在這個階段看到的一個明顯機會就是了解醫生喜歡什麼,市場喜歡什麼,然後真正清楚地了解我們現有的最有效的策略是什麼。我們的目標是真正提高我們在市場上的效率或生產力、系統的效率,例如診斷和可能的依從性。顯然,我們也看到了將產品推向市場的速度的機會。因此,我們已經看到,例如,在 Xolair 的案例中,不同市場的送貨上門速度正在加快。所以,是的,有一些挑戰,但我們未來顯然有機會。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • And Peter, I'd say, overall, our goal is how can we make these changes stick and really now accelerate that transformation, not go back, I think, to your point, to the old ways of working.

    彼得,我想說,總的來說,我們的目標是我們如何才能讓這些改變堅持下去,現在真正加速這種轉變,而不是回到你的觀點,回到舊的工作方式。

  • Operator

    Operator

  • 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, on Zolgensma, you talked about the next catalyst for growth being Europe and Japan. But I wonder if you could give us an update on the potential growth sources in the U.S., given the current level of state testing and Medicaid reimbursement. And then a question for you, Vas, going back to Keyur's opening question. Rather than just thinking about the long-term potential benefits for the perception of the industry from COVID-19 and the industry's response, I wonder if you could give us any thoughts on your interactions with governments here and now and how the perception of the industry has changed or (technical difficulty).

    首先,在 Zolgensma 上,您談到了歐洲和日本的下一個增長催化劑。但我想知道,鑑於目前的州檢測和醫療補助報銷水平,您能否向我們提供有關美國潛在增長來源的最新信息。 Vas,還有一個問題,回到 Keyur 的開場問題。與其僅僅考慮 COVID-19 對行業認知和行業反應的長期潛在好處,我想知道您是否可以就您現在與政府的互動以及對行業的看法給我們任何想法已經改變或(技術難度)。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Great. Thanks, Simon. I think you're breaking up. I think we lost you, Simon. But I think I got the gist of the second question. So first, on Zolgensma, in the U.S. right now, we are at a steady state of around 100 patients per quarter within the current indication. That's in part as we grow in newborn screening, we, of course, also have the aging-out of the older kids and the older cohort. I think the other element that did dampen a little bit Q1 was that with the COVID pandemic, fewer patients were coming in for switches. And we see that dynamic as well in the early part of April. Nonetheless, we feel confident we're in that steady state of approximately 100 patients a quarter within the current indication.

    偉大的。謝謝,西蒙。我覺得你要分手了。我想我們失去了你,西蒙。但我想我明白了第二個問題的要點。因此,首先,在美國的 Zolgensma 上,目前在目前的適應症範圍內,我們處於每季度約 100 名患者的穩定狀態。這在一定程度上是因為我們在新生兒篩查方面的成長,當然,我們也有年齡較大的孩子和年齡較大的人群老化。我認為確實抑制了第一季度的另一個因素是,隨著 COVID 大流行,更少的患者來換藥。我們在 4 月初也看到了這種動態。儘管如此,我們有信心在目前的適應症範圍內,我們處於每季度大約 100 名患者的穩定狀態。

  • Now when you look at Europe, as a reminder, we have a very broad indication within Europe. We've already seen early access agreements announced by German -- a few German sick funds that would be available as soon as we're approved in Europe. So we expect to see very rapid uptake in some countries within Europe on launch. So that will give us the next, I think, inflection point is our launch across a range of European markets. And our teams are working hard to get early access agreements in place to enable patients to receive the therapy even ahead of the final reimbursement agreement and then of course, Japan and a range of other markets around the world. So that will be the next set of inflection points for the brand and then following on that, the U.S. expansion beyond 2 years of age. So when you take each of those in turn, we're still well on track to a multibillion-dollar product with respect to Zolgensma.

    現在,當您查看歐洲時,提醒一下,我們在歐洲有一個非常廣泛的跡象。我們已經看到了德國宣布的早期訪問協議——一旦我們在歐洲獲得批准,一些德國的病假基金就可以使用。因此,我們預計在推出時會在歐洲一些國家/地區迅速普及。因此,我認為,這將給我們帶來下一個拐點,即我們在一系列歐洲市場的推出。我們的團隊正在努力製定早期使用協議,以使患者甚至在最終報銷協議之前就能夠接受治療,當然還有日本和世界各地的一系列其他市場。因此,這將是該品牌的下一組拐點,然後是 2 歲以上的美國擴張。因此,當您依次考慮其中的每一個時,我們仍然在朝著 Zolgensma 數十億美元的產品邁進。

  • I would say on government -- I would say broadly within a range of stakeholders, if you look at the engagement from government groups ranging from the G20, individual governments reaching out to industry and asking for our support in a very positive way, a range of collaborations that involve the biopharmaceutical industry, the nonprofits, government, academic institutions, I certainly feel that the overall tone is very positive towards the industry at this time. I think if we can do our part and behave in a way that is really supportive to the overall pandemic response, this is an opportunity as well to reset, I think, the overall relationship between the industry and government. So I am hopeful on that front. But of course, it's still early days, and we'll have to see how the situation evolves over the coming year.

    關於政府,我想說的是廣泛的利益相關者,如果你看看 G20 等政府團體的參與,個別政府接觸到行業並以非常積極的方式尋求我們的支持,範圍很廣在涉及生物製藥行業、非營利組織、政府、學術機構的合作中,我當然覺得目前對這個行業的整體基調是非常積極的。我認為,如果我們能儘自己的一份力量並以真正支持整體大流行應對的方式行事,我認為這也是一個重新調整行業與政府之間整體關係的機會。所以我在這方面充滿希望。但是,當然,現在還為時尚早,我們將不得不看看未來一年情況會如何發展。

  • Operator

    Operator

  • Next question comes from the line of Tim Anderson from Wolfe Research.

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

  • Timothy Minton Anderson - MD of Equity Research

    Timothy Minton Anderson - MD of Equity Research

  • A couple of questions, please. On Entresto and the filing for HFpEF, that was on a primary endpoint that technically failed. And FDA is usually quite stringent on how they interpret cardiovascular trials. So I'm wondering what you're realistically hoping to accomplish with that filing? And if you could just kind of identify what you think is the subgroup of most relevance there?

    有幾個問題,請。關於 Entresto 和 HFpEF 的申請,這是在技術上失敗的主要終點。 FDA 通常對他們如何解釋心血管試驗非常嚴格。所以我想知道你實際上希望通過該文件實現什麼?如果你能確定你認為最相關的子組是什麼?

  • And then a second question on inclisiran, you'll be launching that years ahead of having outcomes data. I'm thinking one potential strategy, especially with this very novel type of product, would be to be disruptive on price if you're positioning it almost as a vaccine-like product. So I'm just wondering if you can comment on launch dynamics in the absence of outcomes data and how price may play a role?

    然後是關於 inclisiran 的第二個問題,您將在獲得結果數據之前幾年推出。我在想一個潛在的策略,特別是對於這種非常新穎的產品,如果你將其定位為幾乎類似疫苗的產品,那麼它會在價格上造成破壞。所以我只是想知道您是否可以在沒有結果數據的情況下評論發布動態以及價格如何發揮作用?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thanks, Tim. First, on Entresto, HFpEF, John?

    謝謝,蒂姆。首先,關於 Entresto、HFpEF、John?

  • John Tsai - Head of Global Drug Development & Chief Medical Officer

    John Tsai - Head of Global Drug Development & Chief Medical Officer

  • Yes. Thanks, Tim. Thanks for the question. On HFpEF, as you know, we narrowly missed this statistical significance for the broader population. We've had good dialogue with the agency on this. I think, as you know, a p-value of 0.05 versus 0.06 is a 6% chance versus a 5% chance that was by Type 1 error. So given that, we see the benefit in the broader overall population. We've also readjudicated and looked at the endpoints with another group, this time with DCRI. And we're having good conversations with the FDA in terms of looking at these endpoints. So we are moving forward and have had good dialogue with the agency. And we look forward to having these discussions with them.

    是的。謝謝,蒂姆。謝謝你的問題。如您所知,在 HFpEF 上,我們差一點錯過了對更廣泛人群的統計意義。在這方面,我們與該機構進行了良好的對話。我認為,如您所知,0.05 對 0.06 的 p 值是 6% 的機會,而 5% 的機會是由類型 1 錯誤引起的。因此,鑑於此,我們看到了更廣泛的整體人口的好處。我們還與另一組(這次是 DCRI)一起重新判斷並查看了端點。在查看這些終點方面,我們正在與 FDA 進行良好的對話。因此,我們正在向前邁進,並與該機構進行了良好的對話。我們期待與他們進行這些討論。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • And then Marie-France, on the inclisiran?

    然後是 Marie-France,在 inclisiran 上?

  • Marie-France Tschudin - President of Novartis Pharmaceuticals

    Marie-France Tschudin - President of Novartis Pharmaceuticals

  • So clearly, the idea with inclisiran is to bring the product to a very broad patient population. We know that there's a huge unmet need in the cardiovascular area. We know it's a leading cause of death, and we know that this is hugely costly to health care systems. What we want to do is price this product responsibly. And what we're learning from payers is that there is an interest in entering much broader agreements with us on this product. So it's early to talk about what that would potentially look like. But certainly, the idea behind the acquisition of this product was to bring it to a broad patient population who can benefit from it and potentially bend the curve of life.

    很明顯,inclisiran 的想法是將產品帶給非常廣泛的患者群體。我們知道心血管領域存在巨大的未滿足需求。我們知道這是導致死亡的主要原因,而且我們知道這對醫療保健系統來說代價高昂。我們要做的是負責任地為這款產品定價。我們從付款人那裡學到的是,有興趣與我們就該產品達成更廣泛的協議。所以現在談論它可能是什麼樣子還為時過早。但可以肯定的是,收購該產品背後的想法是將其帶給可以從中受益並可能改變生活曲線的廣大患者群體。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thanks, Marie-France. Just one more comment I'm thinking on HFpEF. I think maybe 3 nuances, one, that the study this under central adjudication missed the primary endpoint, but on physician adjudication actually was statistically significant. And then there were 2 groups, women as well as patients with ejection fraction less than, I think, 68% or 69% that also had positive results. So there's a lot of dynamics, I think, here. But as John pointed out, most important, great dialogue with the FDA to agree on a readjudication approach. We've completed that and we'll submit the full data package. I've already submitted the full data package to the agency.

    謝謝,瑪麗-法蘭西。我正在考慮關於 HFpEF 的另一條評論。我認為可能有 3 個細微差別,一個是,這項在中央裁決下的研究錯過了主要終點,但在醫生裁決下實際上具有統計學意義。然後有兩組,女性以及射血分數低於我認為 68% 或 69% 的患者也有陽性結果。所以我認為這裡有很多動態。但正如約翰所指出的,最重要的是,與 FDA 進行大量對話以就重新裁決方法達成一致。我們已經完成了,我們將提交完整的數據包。我已經向該機構提交了完整的數據包。

  • Operator

    Operator

  • Next question comes from the line of Eric Le Berrigaud from Bryan Garnier.

    下一個問題來自 Bryan Garnier 的 Eric Le Berrigaud。

  • Eric Le Berrigaud - Managing Partner Equity & Research

    Eric Le Berrigaud - Managing Partner Equity & Research

  • Yes. Two questions. First is after the impressive operating margin for Sandoz in Q1, excluding COVID-19 effect of 25%, maybe to understand what was behind that in terms of mix of different businesses but also productivity gains and the sustainability of that going forward? And the second question is maybe to talk a little bit about the dynamics behind the MS market and maybe for the different classes and the S1P class, in particular.

    是的。兩個問題。首先是在第一季度 Sandoz 令人印象深刻的營業利潤率(不包括 25% 的 COVID-19 影響)之後,也許是為了了解不同業務組合的背後是什麼,以及生產力的提高和未來的可持續性?第二個問題可能是談談 MS 市場背後的動態,可能是針對不同的類別,特別是 S1P 類別。

  • Excluding COVID-19 impacts, how is Gilenya doing, especially in the U.S.? Mayzent was pretty much in line. How are they doing versus other products in the class? How do you see them going forward? And is it fair to expect a significant shift in your resources when ofatumumab is available? And since you've reiterated confidence in reaching $1 billion with Beovu, would you say the same for Mayzent, please?

    排除 COVID-19 的影響,Gilenya 的情況如何,尤其是在美國? Mayzent 幾乎是一致的。與班上的其他產品相比,他們的表現如何?你如何看待他們的未來?當奧法木單抗可用時,期望您的資源發生重大轉變是否公平?既然您重申了與 Beovu 達成 10 億美元的信心,請您對 Mayzent 也這麼說嗎?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thank you, Eric. So first, on Sandoz margins, Richard?

    謝謝你,埃里克。那麼首先,關於 Sandoz 的利潤,Richard?

  • Richard Saynor - CEO of Sandoz

    Richard Saynor - CEO of Sandoz

  • Thank you, Eric. Yes, it's pleasing to see such a strong quarter for Sandoz really across all geographies and most of the portfolio. The margin growth really came from a number of places, a good cost control, which washed out through our excellent work that we saw last year. Mix, the portfolio has evolved, particularly around strong performance around the biologics, which have generally have higher margins. And pricing has not eroded to the same degree. Plus we saw a delay of some of the pricing reforms that we expected in quarter 1, which we'll expect later into the year. Clearly, margin is always variable in the generics business. So clearly, we're still focusing on maintaining cost control and driving margin forward, and we'll continue on that basis.

    謝謝你,埃里克。是的,很高興看到山德士在所有地區和大部分投資組合中都表現出如此強勁的季度表現。利潤增長確實來自很多地方,良好的成本控制,通過我們去年看到的出色工作而被淘汰。混合,投資組合已經發展,特別是圍繞生物製劑的強勁表現,這些生物製劑通常具有更高的利潤率。定價並沒有受到同樣程度的侵蝕。此外,我們看到我們在第一季度預期的一些定價改革推遲了,我們預計會在今年晚些時候進行。顯然,仿製藥業務的利潤總是可變的。很明顯,我們仍然專注於保持成本控制和提高利潤率,我們將在此基礎上繼續前進。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thanks, Richard. And on MS market dynamics, Marie-France?

    謝謝,理查德。關於 MS 市場動態,Marie-France?

  • Marie-France Tschudin - President of Novartis Pharmaceuticals

    Marie-France Tschudin - President of Novartis Pharmaceuticals

  • So if I start with Gilenya, just remind you that Gilenya remains the second-most prescribed DMT brand worldwide. It's still a strong product. And it's actually doing very well in this COVID period due to, obviously, the very strong TRx base. So we expect relatively stable performance with Gilenya. If I can make some comments on Mayzent, we actually saw very good momentum in Q1. So we had a 76% quarter-over-quarter growth and NBRx of plus 16% in the U.S. So that was the highest growth of any DMT with a prescriber base that's growing steadily.

    因此,如果我從 Gilenya 開始,請提醒您 Gilenya 仍然是全球第二大處方 DMT 品牌。它仍然是一個強大的產品。顯然,由於非常強大的 TRx 基礎,它在這個 COVID 時期實際上表現非常好。因此,我們預計 Gilenya 的表現相對穩定。如果我可以對 Mayzent 發表一些評論,我們實際上在第一季度看到了非常好的勢頭。因此,我們在美國實現了 76% 的季度環比增長和 16% 的 NBRx 增長。因此,這是所有 DMT 中處方藥基數穩定增長的最高增長。

  • Again, we have a strong value proposition in this space. We're the only product that has been studied and has shown data in a typical SPMS population. We still believe that Mayzent has blockbuster potential. But we do acknowledge that this is going to take time as we try to identify patients and make sure that we have the right positioning in the marketplace. As we're in this COVID period, clearly, the MS space is being affected, especially the dynamic side of the market. So we do expect a slowdown. But as things get back to normal, we believe we have a good foundation for Mayzent in this patient population.

    同樣,我們在這個領域有很強的價值主張。我們是唯一經過研究並在典型 SPMS 人群中顯示數據的產品。我們仍然相信 Mayzent 具有巨大的潛力。但我們確實承認,這需要時間,因為我們試圖識別患者並確保我們在市場上擁有正確的定位。顯然,我們正處於這個 COVID 時期,MS 領域正在受到影響,尤其是市場的動態方面。因此,我們確實預計會放緩。但隨著事情恢復正常,我們相信我們在這個患者群體中為 Mayzent 奠定了良好的基礎。

  • Lastly, on ofatumumab, that's clearly the focus, bringing a highly efficacious B-cell therapy, which is safe, which can be administered at home. And particularly now in a post-COVID period, this is going to be absolutely paramount for the market and for patients. So we're very excited about this prospect. And clearly, we're focusing for a big launch in this area.

    最後,在 ofatumumab 上,這顯然是重點,帶來了一種高效的 B 細胞療法,它是安全的,可以在家中進行。尤其是現在在後 COVID 時期,這對於市場和患者來說絕對是最重要的。因此,我們對這一前景感到非常興奮。顯然,我們正專注於在這一領域進行大規模發布。

  • Operator

    Operator

  • Next question comes from the line of Seamus Fernandez from Guggenheim.

    下一個問題來自古根海姆的 Seamus Fernandez。

  • Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

    Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

  • So just wanted to get a couple of updates. One, could you guys just update us on timelines for your factor B inhibitor? I know that, that's one agent that many investors are really interested to see updates on. Just hoping to get a better understanding of that and perhaps data presentations that could occur later this year or timelines for completion of some of the Phase II studies.

    所以只是想獲得一些更新。一,你們能否向我們介紹一下你們的 B 因子抑製劑的時間表?我知道,這是許多投資者真正有興趣看到更新的代理之一。只是希望能更好地理解這一點,也許今年晚些時候可能會出現數據展示或完成一些 II 期研究的時間表。

  • And then second, can you just help us understand a little bit better the relative impacts of the Gilenya settlement opportunity? We saw the successful conclusion of the IPR. Just wanted to get a quick sense of how you're thinking about the duration of Gilenya going forward.

    其次,您能否幫助我們更好地了解 Gilenya 定居點機會的相對影響?我們看到了IPR的圓滿結束。只是想快速了解一下您對 Gilenya 未來持續時間的看法。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thanks, Seamus. So first, on LNP023, our factor B inhibitor, John?

    謝謝,西莫。那麼首先,關於 LNP023,我們的因子 B 抑製劑,約翰?

  • John Tsai - Head of Global Drug Development & Chief Medical Officer

    John Tsai - Head of Global Drug Development & Chief Medical Officer

  • Seamus, thanks for the question. On LNP023, our factor B inhibitor, as you know, we're going for multiple indications. First, in the PNH, paroxysmal nocturnal hemoglobinuria, we're moving forward. The approach that we're taking is a mixed Phase IIa/b approach with interim analyses. And we're looking to get results at the end of this year. This is tracking on time, and we'll be seeing those results and moving forward with a Phase III at the close of this year.

    Seamus,謝謝你的提問。如您所知,在我們的 B 因子抑製劑 LNP023 上,我們將尋求多種適應症。首先,在 PNH(陣發性夜間血紅蛋白尿)中,我們正在向前發展。我們採用的方法是混合階段 IIa/b 方法和中期分析。我們希望在今年年底獲得結果。這是按時進行的,我們將看到這些結果,並在今年年底推進第三階段。

  • The second set of indications is in our nephropathy. So we've got C3 glomerular nephropathy, membranous and IgA nephropathy. Those are also combined Phase IIa/b studies. Those are moving forward also. We expect to see results early part of next year and those also are on time. And once we get those results, based on the interim, we could either file with the interim or we would move forward in terms of a full Phase III at the beginning of next year.

    第二組適應症是我們的腎病。所以我們有C3腎小球腎病、膜性腎病和IgA腎病。這些也是 IIa/b 期聯合研究。這些也在向前發展。我們預計會在明年年初看到結果,而且這些結果也將按時進行。一旦我們得到這些結果,根據臨時文件,我們可以提交臨時文件,或者我們將在明年年初推進完整的第三階段。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thanks, John. And on Gilenya, it's worthwhile noting there's really 2 separate -- there were 2 separate paths, one is the IPR hearing, one is the district court. The IPR case, as you saw and Seamus reported in his note, was dismissed. That was based on procedural grounds for the standing of the claimant. And so on the district court, there really is no read-across from the IPR to the district court hearing. There is a single filer still remaining in the district court, and we expect a ruling in the mid of this year. And we stand fully behind the IP of Gilenya, both the current patent as well as the additional patents that we've subsequently been granted. And so we'll look forward to keeping you up to date on that and, of course, give the market clarity as soon as we have clarity ourselves.

    謝謝,約翰。在 Gilenya 上,值得注意的是確實有兩條獨立的路徑——有兩條獨立的路徑,一條是知識產權聽證會,一條是地方法院。正如你所看到的和 Seamus 在他的筆記中報告的那樣,知識產權案件被駁回了。這是基於索賠人地位的程序依據。等等地區法院,真的沒有從知識產權到地區法院聽證的閱讀。地區法院仍有一名申報人,我們預計將在今年年中作出裁決。我們完全支持 Gilenya 的 IP,包括當前專利以及我們隨後獲得的其他專利。因此,我們期待讓您了解最新情況,當然,一旦我們自己清楚,我們就會盡快讓市場變得清晰。

  • Operator

    Operator

  • Next question comes from the line of Florent Cespedes from Societe Generale.

    下一個問題來自法國興業銀行的 Florent Cespedes。

  • Florent Cespedes - Senior Equity Analyst

    Florent Cespedes - Senior Equity Analyst

  • Florent Cespedes from Societe Generale. Two quick questions. The first one for Marie-France on ofatumumab, a follow-up on ofatumumab. Marie-France, could you share with us how do you see the launch of this important product mid-year, given the current environment and also given the fact that MS is pretty competitive? You have given some examples during your presentation. But if you could share with us a little more detail, that would be great.

    來自法國興業銀行的 Florent Cespedes。兩個快速的問題。 Marie-France 的第一個關於 ofatumumab 的案例,是對 ofatumumab 的跟進。 Marie-France,您能否與我們分享一下,鑑於當前的環境以及 MS 極具競爭力的事實,您如何看待年中推出這一重要產品?你在演講中舉了一些例子。但是,如果您可以與我們分享更多細節,那就太好了。

  • My second question for John and Susanne. It's on Lu-PSMA-617 on prostate cancer. As this year, we anticipate and you expect the Phase III trial, could you maybe share with us the opportunity for this product and the positioning on the prostate cancer market?

    我要問約翰和蘇珊的第二個問題。它在關於前列腺癌的 Lu-PSMA-617 上。正如今年,我們預計並且您期待 III 期試驗,您能否與我們分享該產品的機會以及在前列腺癌市場上的定位?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • So first, on ofatumumab, Marie-France?

    那麼首先,關於ofatumumab,Marie-France?

  • Marie-France Tschudin - President of Novartis Pharmaceuticals

    Marie-France Tschudin - President of Novartis Pharmaceuticals

  • So the first thing I'd say is that we have very well-established relationships with physicians in this area. So we have a very strong portfolio across MS and bringing ofatumumab to a physician population that we know and we're familiar with. Having said that, clearly, this is going to be a different launch from what we're used to. And that's exactly what we're preparing for. We're looking at this from a prescriber and other key stakeholder perspective, whether there are going to be digital interactions at first. We're playing it flexible, whether we have different approaches, country-by-country, state-by-state.

    所以我要說的第一件事是,我們與該領域的醫生建立了非常良好的關係。因此,我們在 MS 方面擁有非常強大的產品組合,並將 ofatumumab 帶給我們認識和熟悉的醫生群體。話雖如此,顯然,這將是與我們習慣的不同的發布。這正是我們正在準備的。我們從處方者和其他關鍵利益相關者的角度來看待這個問題,首先是否會有數字交互。我們玩得很靈活,無論我們有不同的方法,逐個國家,逐個州。

  • But clearly, what we're not going to do is slow down. Because if there was any time for us to bring a highly efficacious product to a broad population in a setting where patients don't have to be in the hospital, it is now. So we're going to continue to work with payers. And our first priority is clearly we understand that there is going to be a slowdown in the dynamic market in MS. But our clear priority is to make sure that we make it as easy as possible so that when patients do go back to their physicians, they can easily transition to ofatumumab.

    但很明顯,我們不會做的是放慢速度。因為如果我們有時間在患者不必住院的情況下將高效產品帶給廣大人群,那就是現在。因此,我們將繼續與付款人合作。我們的首要任務顯然是我們明白 MS 的動態市場將會放緩。但我們明確的首要任務是確保我們盡可能簡化它,以便當患者真的回到他們的醫生那裡時,他們可以輕鬆地過渡到奧法木單抗。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • And then on the PSMA-617 opportunity, Susanne?

    然後是 PSMA-617 的機會,Susanne?

  • Susanne Schaffert - President of Novartis Oncology

    Susanne Schaffert - President of Novartis Oncology

  • Yes. Thank you. Thank you, Florent, for the question. So actually, prostate cancer is the second-most commonly diagnosed cancer in men. There's an incidence of 1.3 million globally. And for the U.S., you have to assume around 175,000 patients. And what we know is that about 10% to 20% of patients with prostate cancer become castration-resistant with a 5-year follow-up -- and 80% 5-year follow-up, so -- and 80% of these patients become metastatic. So there's a very, very high unmet medical need and we're very much looking forward to have Lu-PSMA-617 moving out later in the year.

    是的。謝謝你。謝謝你,弗洛倫特的問題。所以實際上,前列腺癌是男性中第二常見的診斷癌症。全球發病率為 130 萬。對於美國,您必須假設大約有 175,000 名患者。我們所知道的是,大約 10% 到 20% 的前列腺癌患者在 5 年的隨訪中變得去勢抵抗 - 80% 的 5 年隨訪,所以 - 這些患者中有 80%變成轉移性的。所以有一個非常非常高的未滿足的醫療需求,我們非常期待 Lu-PSMA-617 在今年晚些時候推出。

  • And first regarding positioning, so the VISION trial that is fully recruited is in treatment of patients with metastatic CRPC after 1 line of novel antiandrogen androgen-receptor-directed therapy and 1 line of chemotherapy. So it means third and fourth line of therapy. As said, the VISION trial is fully recruited. It's an event-based trial, and we expect readout versus the end of the year.

    首先是關於定位,所以完全招募的 VISION 試驗是在 1 線新型抗雄激素雄激素受體定向治療和 1 線化療後治療轉移性 CRPC 患者。所以它意味著第三和第四線治療。如前所述,VISION 試驗已全部招募。這是一項基於事件的試驗,我們預計將在今年年底公佈。

  • Operator

    Operator

  • Next question comes from the line of Matthew Weston from Crédit Suisse.

    下一個問題來自瑞士信貸的 Matthew Weston。

  • Matthew Weston - MD and Co-Head of European Pharmaceutical Equity Research

    Matthew Weston - MD and Co-Head of European Pharmaceutical Equity Research

  • Just two quick follow-ups, please, on previous questions. The first on ofatumumab, Marie-France. You made it clear a number of times how confident you are on taking the launch to market irrespective of the underlying circumstances. Can you just remind me, is it correct that the first dose has to be administered in the clinic and therefore, we do at least need some degree of normality within the health care system before we can see patients getting dosed? Or do you expect that there's going to be some waiver around that requirement?

    請就之前的問題進行兩次快速跟進。第一個關於ofatumumab,Marie-France。無論潛在情況如何,您多次明確表示您對將產品推向市場的信心有多大。你能提醒我嗎,第一劑必須在診所給藥是否正確,因此,我們至少需要在醫療保健系統內達到某種程度的正常狀態才能看到患者接受給藥?或者您是否希望對該要求有一些豁免?

  • And then the second question regarding Sandoz margins. You clearly set out the positive drivers. Can I just check, particularly given that we have seen a meaningful impact of generics in the oncology setting, was there any benefit within the Sandoz business of you launching generics against your own product at the beginning of this cycle and therefore we're in a very positive mix environment of U.S. exclusivity launches, which should erode rapidly in the second half of the year?

    然後是關於 Sandoz 利潤的第二個問題。你清楚地列出了積極的驅動因素。我可以檢查一下嗎,特別是考慮到我們已經看到仿製藥在腫瘤學領域產生了有意義的影響,山德士業務是否有任何好處,即您在本週期開始時針對您自己的產品推出仿製藥,因此我們處於美國獨家推出的非常積極的混合環境,下半年應該會迅速消退嗎?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thank you, Matthew. So on ofatumumab, first up is Marie-France.

    謝謝你,馬修。所以關於ofatumumab,首先是Marie-France。

  • Marie-France Tschudin - President of Novartis Pharmaceuticals

    Marie-France Tschudin - President of Novartis Pharmaceuticals

  • So as I mentioned before, clearly we do see some disruption happening in the multiple sclerosis market, certainly in the dynamic sector. And we can't say that, that's not going to affect us. But regarding the first dose observation, it can be done by the observation of a health care professional. So technically, we could be sending nurses home. So we think that, that's definitely an opportunity to basically, let's say, address the current situation as it is. Clearly, we're very ambitious about the value proposition that ofatumumab brings to market. And like we said, we feel that there's no reason for us to slow down, even though clearly in the dynamic sector, we will see fewer switches to new therapies in this marketplace.

    因此,正如我之前提到的,很明顯,我們確實看到多發性硬化症市場正在發生一些混亂,尤其是在充滿活力的領域。我們不能這麼說,這不會影響我們。但對於首次劑量觀察,可以通過醫療保健專業人員的觀察來完成。所以從技術上講,我們可以把護士送回家。所以我們認為,這絕對是一個機會,可以說,基本上可以解決當前的情況。顯然,我們對奧法木單抗為市場帶來的價值主張非常雄心勃勃。就像我們說的那樣,我們認為我們沒有理由放慢腳步,儘管顯然在充滿活力的領域,我們將看到在這個市場上轉向新療法的次數減少。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thanks, Marie-France. And Richard, on the Sandoz generic dynamics on Novartis products?

    謝謝,瑪麗-法蘭西。理查德,關於諾華產品的山德士通用動力學?

  • Richard Saynor - CEO of Sandoz

    Richard Saynor - CEO of Sandoz

  • Thank you, Vas. I mean nothing really significant. I mean the bulk of its margin growth has really come from biosimilar and project launches and first-to-market launches that we saw in the end of last year and the beginning of this year rather than generics of the oncology business. So we don't see any really material link between the 2 things.

    謝謝你,瓦斯。我的意思是沒有什麼真正重要的。我的意思是,它的大部分利潤增長實際上來自我們在去年年底和今年年初看到的生物仿製藥和項目啟動以及首次上市,而不是腫瘤學業務的仿製藥。所以我們看不到這兩件事之間有任何真正的實質性聯繫。

  • Operator

    Operator

  • Next question comes from the line of Mark Purcell from Morgan Stanley.

    下一個問題來自摩根士丹利的 Mark Purcell。

  • Mark Douglas Purcell - Equity Analyst

    Mark Douglas Purcell - Equity Analyst

  • It's Mark Purcell from Morgan Stanley. Two questions. Firstly, on digital and it's a bit of a follow-up. Vas, could you help us understand which regions and therapy areas are most ready to adapt to your new digital initiatives when it comes to HCPs and patients and which have the greatest upside over the long term? The reason why I asked the question is that, I guess, if you look at U.K. and Germany, over 60% of patient initiations are remote already, whereas in Italy, where it was very low, you've seen 146% increase in remote initiations over the last 30 days or so. Clearly, in oncology, telemedicine, U.S. penetrations at around 5%, whereas neuroscience has always been in the 20% to 30% over time. So some thoughts on that would be fantastic.

    是摩根士丹利的馬克·珀塞爾。兩個問題。首先,在數字方面,這是一個後續行動。 Vas,您能否幫助我們了解在 HCP 和患者方面,哪些地區和治療領域最準備好適應您的新數字計劃,哪些從長遠來看具有最大的優勢?我問這個問題的原因是,我想,如果你看看英國和德國,已經有超過 60% 的患者啟動是遠程的,而在意大利,這個比例非常低,你已經看到遠程啟動增加了 146%過去 30 天左右的啟動次數。顯然,在腫瘤學、遠程醫療領域,美國的滲透率約為 5%,而隨著時間的推移,神經科學一直保持在 20% 到 30% 之間。所以對此的一些想法會很棒。

  • And then secondly, in terms of pricing in the U.S. At the beginning of the year, you guided to net prices declining by around 2.5% in the U.S. with the U.S. list price increases you put through. Given there's less pricing pressure, it seems, in Sandoz and when we look at the implied list price -- sorry, the implied net price increase on Cosentyx, it looks pretty stable in 1Q despite the fact we've seen a lot of new entrants and a perception that there's going to be increased pricing pressure with that. So if you could help us understand the evolution of price in the U.S., that would be fantastic as well.

    其次,在美國的定價方面。年初,您指導美國的淨價格下降了約 2.5%,您實施了美國定價。鑑於 Sandoz 的定價壓力似乎較小,當我們查看隱含標價時——抱歉,Cosentyx 隱含的淨價格上漲,儘管我們已經看到很多新進入者,但它在第一季度看起來相當穩定以及隨之而來的定價壓力將會增加的看法。因此,如果您能幫助我們了解美國價格的演變,那也太棒了。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Yes. Thank you, Mark. I think on digital, there's a few dynamics I would highlight. And you rightly point, different countries are in different places. But in my mind, for us, Germany being, I think, a relatively positive outlier. But there are 3 markets, in particular, where we have an opportunity to make significant inroads. First and foremost, of course, the United States, where all of our conversations with physicians and health care systems indicate a sudden and dramatic shift to telehealth. And as long some of that can stick as well as digital -- use of digital tools, digital engagement, that could be a significant upside. China, as Marie-France already noted, we've taken this now to scale ourselves. We have partnerships with Tencent, partnerships with other companies. We're now reaching many thousands, tens of thousands, sometimes hundreds of thousands of physicians outward from ourselves to reach our customers but then also enabling patients and physicians to interact on digital channels at scale. And we have a few examples of this already with Tencent and a plan to add others.

    是的。謝謝你,馬克。我認為在數字方面,我會強調一些動態。你正確地指出,不同的國家在不同的地方。但在我看來,對我們來說,德國是一個相對積極的異常值。但特別是有 3 個市場,我們有機會取得重大進展。首先,當然是美國,我們與醫生和醫療保健系統的所有對話都表明美國突然而戲劇性地轉向遠程醫療。只要其中一些可以堅持數字化——使用數字化工具、數字化參與,這可能是一個重大的好處。中國,正如 Marie-France 已經指出的那樣,我們現在已經利用這一點來擴大自己的規模。我們與騰訊有合作關係,與其他公司有合作關係。我們現在從我們自己接觸到成千上萬、有時甚至是數十萬的醫生,以接觸我們的客戶,但同時也使患者和醫生能夠在數字渠道上進行大規模互動。我們已經與騰訊有一些這樣的例子,併計劃增加其他例子。

  • Probably one of the most striking ones, as an example, would be Japan. In Japan, prior to COVID-19, it was unheard of for physicians to engage via digital channels with medical teams or sales representatives. Now it's been forced upon the system and that has to happen digitally. And the uptake is actually quite rapid and quite striking. And that could be a market that sees now a complete switch in the dynamic in terms of the use of digital technologies. Therapeutic areas, of course, I think not a fair time to get into all, but there's a lot of variations. And of course, across therapeutic areas, some are more digitally savvy than others. In our mind, the key is to build platforms, integrated datasets. And we invest a lot on our data plumbing, the hard work, the unsexy work of just getting your data straight and then trying to build scalable platforms around that. And we're trying to collect talent from outside of this sector, whether from the digital consumer health, consumer, other places that have really cracked this at scale and then trying to deploy that within Novartis. And so we'll look forward to keeping everyone up to date as we progress on that. On price dynamics, Harry?

    例如,最引人注目的國家之一可能是日本。在日本,在 COVID-19 之前,醫生通過數字渠道與醫療團隊或銷售代表接觸是聞所未聞的。現在它被強加在系統上,並且必須以數字方式發生。吸收實際上非常迅速且非常引人注目。這可能是一個市場,現在在數字技術的使用方面發生了徹底的轉變。治療領域,當然,我認為不是一個公平的時間進入所有領域,但有很多變化。當然,在治療領域,有些人比其他人更精通數字技術。在我們看來,關鍵是構建平台、集成數據集。我們在數據管道上投入了大量資金,辛勤工作,只是讓你的數據直截了當,然後嘗試圍繞它構建可擴展的平台。我們正試圖從這個領域之外收集人才,無論是來自數字消費者健康、消費者,還是其他真正大規模破解這一領域的地方,然後試圖在諾華內部進行部署。因此,隨著我們在這方面的進展,我們期待讓每個人都了解最新情況。關於價格動態,哈利?

  • Harry Kirsch - CFO

    Harry Kirsch - CFO

  • Yes. So just a few words. Fundamentally, for Innovative Medicines, nothing has changed versus what we have seen 3 months ago. You see this also reflected in our overall pricing effect in quarter 1, which is minus 3% on prices on Innovative Medicines and the total company. Where we potentially have a bit of an upside, and this, of course, what Richard also alluded to, is the Sandoz pricing negative impact is much lower than usual. It's minus 4% on a worldwide basis. But there, we have to watch, is this a temporary effect because maybe other supply chains are a bit more stressed than ours? Or what -- how will that develop? So there maybe in Sandoz maybe a little bit less negative pricing. But overall, also Innovative Medicines at the moment, we see in quarter 1 minus 3%. And nothing from our initial assumption has changed there.

    是的。所以就簡單說幾句。從根本上說,對於創新藥物而言,與我們 3 個月前所見相比,沒有任何變化。您會看到這也反映在我們第一季度的整體定價效應中,即創新藥物和整個公司的價格為負 3%。我們可能有一點好處,當然,理查德也提到過,山德士定價的負面影響比平時要低得多。在全球範圍內為負 4%。但是,我們必須注意,這是否是暫時的影響,因為也許其他供應鏈比我們的壓力更大一些?或者什麼——這將如何發展?因此,山德士的負定價可能會少一些。但總體而言,目前也是創新藥物,我們在第一季度看到負 3%。我們最初的假設沒有任何改變。

  • Operator

    Operator

  • 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

  • Two, please. Just to get your thoughts on second waves. Clearly, not in your guidance, but we're seeing second waves come through in Asia, in Singapore and other areas. And it's, I suppose, reasonably likely that we'll see them across Europe and the U.S. So just your thoughts of that impact maybe over the overall business and maybe particularly with ophthalmology division. And then linked to that, in ophthalmology, I think there was some idea that patients could -- there could be some catch-up dosing of patients maybe in the retinal space. Just a thought in terms of capacity there and how you might do that, given stretched capacity previously and, of course, COVID being the greatest morbidity and mortality in the above 65s.

    兩個,請。只是為了讓您對第二波有想法。顯然,不在您的指導下,但我們看到亞洲、新加坡和其他地區正在經歷第二波浪潮。我認為,我們很有可能會在歐洲和美國看到它們。因此,您對這種影響的想法可能會影響整個業務,尤其是眼科部門。然後與此相關,在眼科領域,我認為有一些想法是患者可以 - 可能會在視網膜空間對患者進行一些補劑。只是考慮那裡的容量以及如何做到這一點,考慮到以前的容量緊張,當然,COVID 是上述 65 歲人群中發病率和死亡率最高的。

  • Second question just on Ultibro, clearly benefiting from being a respiratory product in this space and up a lot. Do you see a new level for Ultibro going forward? How much of that was stocking? How much do you think you've got a new level?

    第二個問題就在 Ultibro 上,顯然受益於作為這個領域的呼吸產品,而且很多。您是否看到 Ultibro 未來的新水平?其中有多少是放養的?你認為你有多少新的水平?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Thanks, Richard. First, with respect to second wave, the way I like to think about how these things happen and especially in this instance is human beings tend to be caught off guard by the exponential nature of outbreaks in general and especially in these kinds of global viral outbreaks. So the exponential curve hits us. Health care systems have to respond. We're not always well prepared, and we have to then as society and then have to scale up to respond. Now for subsequent waves, what's going to happen, I believe, over the course of the coming months is there'll be an exponential expansion of our knowledge of the underlying epidemiology of the virus, how do health care systems need to respond, how the public health systems need to track rates and responses, outbreaks, the improvement, of course, in medical technology if we are able to repurpose drugs or identify better technological solutions.

    謝謝,理查德。首先,關於第二波,我喜歡思考這些事情是如何發生的,尤其是在這種情況下,人類往往對爆發的指數性質感到措手不及,尤其是在這類全球病毒爆發中.所以指數曲線打擊了我們。衛生保健系統必須做出反應。我們並不總是做好充分的準備,作為社會,我們必須這樣做,然後必須擴大規模以應對。現在對於隨後的浪潮,我相信,在接下來的幾個月裡,我們對病毒潛在流行病學、醫療保健系統需要如何應對、如果我們能夠重新調整藥物用途或找到更好的技術解決方案,公共衛生系統需要跟踪醫療技術的發生率和反應、爆發以及醫療技術的改進。

  • So all of that makes us think and make me think that if there are future waves, we can manage them more effectively without having hopefully the same level of disruption to the health care system. Because I think one of the things that will become more clear, and we hear this from our conversations with physicians and health care systems, is there is a hidden cost, a significant hidden cost to all of the averted and delayed care that's happening for patients with chronic diseases all around the world. That's okay for a little bit of time, but it's not something that's sustainable. And there will be significant morbidity and mortality associated with that. So I think we're aligned with health care systems, physicians and patients to get people back into the clinic in a safe, sustainable way and hopefully keep it that way, independent of future COVID outbreaks. Now specific on ophthalmology, Marie-France, thoughts?

    因此,所有這一切都讓我們思考並讓我思考,如果未來有浪潮,我們可以更有效地管理它們,而不會對醫療保健系統造成同樣程度的破壞。因為我認為有一件事情會變得更清楚,我們從與醫生和醫療保健系統的對話中聽到這一點,是否存在隱藏成本,對於所有為患者發生的避免和延遲的護理而言,這是一筆巨大的隱藏成本與世界各地的慢性疾病。這在一段時間內是可以的,但這不是可持續的。與此相關的發病率和死亡率會很高。因此,我認為我們與醫療保健系統、醫生和患者保持一致,以安全、可持續的方式讓人們回到診所,並希望保持這種方式,不受未來 COVID 爆發的影響。現在具體談談眼科,Marie-France,想法?

  • Marie-France Tschudin - President of Novartis Pharmaceuticals

    Marie-France Tschudin - President of Novartis Pharmaceuticals

  • Yes. So maybe -- I mean it's a very good segue because clearly retina patients are not going to the centers, but that cannot last. They're going to have to go back to their therapies. So we do anticipate capacity issues for sure and clearly as social distancing rules will probably continue in this space. But what we're doing right now is we're trying to work with clinics and health care centers to improve, first of all, how that capacity can look like, how we can work with centers to help them with their flow of patients. We're also looking at home monitoring solutions for patients to track their own vision and connect with HCP from home, so they're really only going to the centers when they need to go. There are some remote care solutions, where HCPs can move nearer to the patient. We're looking at sort of mobile units in the U.K. and trying to just address some of these capacity issues post the confinement period.

    是的。所以也許——我的意思是這是一個非常好的選擇,因為顯然視網膜患者不會去中心,但這不會持續下去。他們將不得不回到他們的療法。因此,我們確實明確地預見到了容量問題,因為社交距離規則可能會在這個領域繼續存在。但我們現在正在做的是,我們正在努力與診所和醫療保健中心合作,首先改善這種能力,我們如何與中心合作,幫助他們處理病人的流動。我們還在為患者尋找家庭監控解決方案,以跟踪他們自己的視力並在家中與 HCP 聯繫,因此他們實際上只在需要時才去中心。有一些遠程護理解決方案,其中 HCP 可以更靠近患者。我們正在研究英國的某種移動設備,並試圖在限制期後解決其中的一些容量問題。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Yes. And the only thing I would add is the conversations we've had with specialist physicians in ophthalmology, dermatology, neurology in the U.S. all point to a readiness and that preparation to have weekend clinics, after-hour clinics to kind of rapidly catch up on the backlog of patients. Now on respiratory, I'll just briefly answer that Ultibro, I think, continues in a very steady way. We did have a positive CHMP opinion for Atectura. And hopefully, we'll soon be launching a triple in asthma. So really for us, the next inflection point in inhaled respiratory will be the launch of our triple combination.

    是的。我唯一要補充的是,我們與美國眼科、皮膚科、神經科專科醫生的對話都表明,我們已經準備好開設週末診所、下班後診所,以便快速趕上患者的積壓。現在關於呼吸系統,我只想簡單地回答,我認為 Ultibro 會以非常穩定的方式繼續發展。我們確實對 Atectura 有積極的 CHMP 意見。希望我們很快就會推出治療哮喘的三聯療法。所以對我們來說,吸入式呼吸系統的下一個轉折點將是推出我們的三重組合。

  • Operator

    Operator

  • Next question is coming from the line of Laura Sutcliffe from UBS.

    下一個問題來自瑞銀的 Laura Sutcliffe。

  • Laura Sutcliffe - Equity Research Analyst

    Laura Sutcliffe - Equity Research Analyst

  • Firstly, on Beovu, we know you've instigated new sort of safety monitoring investigations and so on. But what is it that you actually need to see from that activity to get this back on track commercially? Is it a specific data point? Is it a publication? Is it just looking at it over a long time? So that's the first question.

    首先,在 Beovu 上,我們知道您發起了新的安全監控調查等。但是,您實際上需要從該活動中看到什麼才能使其在商業上重回正軌?它是一個特定的數據點嗎?是出版物嗎?只是看了很久嗎?所以這是第一個問題。

  • And then the second question is on Sandoz. You've mentioned that terminating the Aurobindo agreement provides you with an opportunity to optimize the U.S. business. So could you just tell us maybe a little bit more about that and what you think is the right sort of shape for Sandoz in the U.S.?

    然後第二個問題是關於 Sandoz。您提到終止 Aurobindo 協議為您提供了優化美國業務的機會。所以你能告訴我們更多關於這方面的信息嗎?你認為山德士在美國的正確形狀是什麼?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Yes. So just in the interest of time, I'll take the remaining questions because we only have a few minutes left. So on Beovu, right now, the goal is to reassure physicians on the clinical profile, ensure that we are only injecting the product in patients who don't have inflammation in their eye. As we -- we believe as we continue to get more experience, we'll have a better sense of these rates and get physicians more comfortable. It's notable that outside the U.S. there is slit-lamp examination for any inflammation in the eye, which doesn't always happen in the U.S. So we're hopeful that, that could potentially mitigate any of these rare signals outside the U.S. In the medium term, we have a full team that's working around the clock to try to find any of the specific determinant, either from a patient standpoint, a product standpoint or a setting in the clinic standpoint that might be leading to these rare events.

    是的。因此,出於時間考慮,我將回答剩下的問題,因為我們只剩下幾分鐘了。因此,在 Beovu 上,目前的目標是讓醫生對臨床情況放心,確保我們只將產品注射到眼部沒有炎症的患者身上。正如我們 - 我們相信,隨著我們繼續獲得更多經驗,我們將對這些比率有更好的了解,並使醫生更加舒適。值得注意的是,在美國以外,有裂隙燈檢查眼睛是否有炎症,這在美國並不總是發生所以我們希望這可能會減輕美國以外的任何這些罕見信號。術語,我們有一個完整的團隊夜以繼日地工作,試圖從患者的角度、產品的角度或臨床角度的環境中找到任何可能導致這些罕見事件的特定決定因素。

  • And if we can find any insights, including potential treatment with steroids or other interventions, we'll, of course, then roll that out. And then in the longer term, we have a full range, the largest range of Phase III head-to-head studies and other studies to fully characterize the product, which we hope will demonstrate the clear clinical benefit and overall profile of the product to support its significant use. And we continue to stand behind our belief we can make this a blockbuster medicine. I would note we had similar challenges with Gilenya, other products in other classes have had challenges. But based on a strong profile, it can ultimately overcome them.

    如果我們能找到任何見解,包括潛在的類固醇治療或其他干預措施,我們當然會推出。然後從長遠來看,我們有全方位、最大範圍的 III 期頭對頭研究和其他研究來充分錶徵該產品,我們希望這將證明該產品的明確臨床益處和整體概況,以支持其重要用途。我們繼續堅持我們的信念,我們可以把它變成一鳴驚人的藥物。我會注意到我們在 Gilenya 上遇到了類似的挑戰,其他類別的其他產品也遇到了挑戰。但基於強大的形象,它最終可以克服它們。

  • With respect to Aurobindo, I think, as been highlighted on the call, we're still -- important to see really the pricing dynamic -- the Aurobindo business or the oral solids business that we're now retaining, important to see the pricing dynamics in the U.S. And Richard and team are investing now in a full-scale portfolio longer term that will bring hopefully a steady flow of [Sandoz] into the U.S. market. And this will form a base for that. But really, the key now is really to look at the pricing dynamics. We'll be able to formulate a clearer strategy over the coming months and provide you a clearer outlook alongside that at that time.

    關於 Aurobindo,我認為,正如電話會議中強調的那樣,我們仍然 - 重要的是看到真正的定價動態 - 我們現在保留的 Aurobindo 業務或口服固體業務,重要的是看到定價美國的動態 理查德和他的團隊現在正在投資一個全面的長期投資組合,這將有望使 [Sandoz] 穩定流入美國市場。這將為此奠定基礎。但實際上,現在的關鍵是真正關注定價動態。在接下來的幾個月裡,我們將能夠制定更清晰的戰略,並在那時為您提供更清晰的前景。

  • Operator

    Operator

  • Next questions come from the line of Emmanuel Papadakis from Barclays.

    接下來的問題來自巴克萊的 Emmanuel Papadakis。

  • Emmanuel Douglas Papadakis - MD & Head of European Pharmaceuticals Research

    Emmanuel Douglas Papadakis - MD & Head of European Pharmaceuticals Research

  • I'll try to be brief. Maybe a couple on Piqray. Great initial momentum seems to have slowed a little bit. The testing ambition for 40% by the end of this year seems a little on the low side. I think it was 25% by the end of Q4. So just what's the hurdle there? Is that the main gating factor on driving the commercial uptake? Any thoughts on competitive risk from the Akt inhibitors would be welcomed as clear overlap in terms of the biomarker selection of population? Could you just confirm you're not planning to do a combination study with Kisqali as part of the EPIC program?

    我會盡量簡短。也許是 Piqray 上的一對。最初的巨大勢頭似乎已經放緩了一點。到今年年底達到 40% 的測試目標似乎有點偏低。我認為到第四季度末是 25%。那麼那裡的障礙是什麼?這是推動商業吸收的主要決定因素嗎?任何關於 Akt 抑製劑競爭風險的想法都會受到歡迎,因為在人群的生物標誌物選擇方面有明顯的重疊?您能否確認您不打算與 Kisqali 進行聯合研究作為 EPIC 計劃的一部分?

  • And then Vas, maybe just your thoughts on business development. You've been pretty clear in the past on saying that the envelope planning to remain relatively active. Does the current situation offer opportunities? Or does it rather force you to concentrate your time in terms of internal situation at Novartis? And then if I may, a quick follow-up on inclisiran. You've flagged the costs in the second half. Are you actually planning to put a primary care resource behind the product at this stage?

    然後是 Vas,也許只是您對業務發展的想法。你過去很清楚地說信封計劃保持相對活躍。目前的情況是否提供了機會?還是它會迫使你把時間集中在諾華的內部情況上?然後,如果可以的話,對 inclisiran 進行快速跟進。你已經標記了下半年的成本。您是否真的打算在這個階段為產品提供初級保健資源?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • On which -- Emmanuel, your last question was on which product, inclisiran?

    關於哪個——Emmanuel,你的最後一個問題是關於哪個產品,inclisiran?

  • Emmanuel Douglas Papadakis - MD & Head of European Pharmaceuticals Research

    Emmanuel Douglas Papadakis - MD & Head of European Pharmaceuticals Research

  • Inclisiran.

    內里西蘭。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • On inclisiran. Sorry. Okay. Thank you. So Susanne, on the two Piqray questions?

    在 inclisiran 上。對不起。好的。謝謝你。那麼蘇珊娜,關於兩個 Piqray 問題?

  • Susanne Schaffert - President of Novartis Oncology

    Susanne Schaffert - President of Novartis Oncology

  • Yes. Thanks a lot, Emmanuel, for the questions. So we were actually quite pleased with the performance of Piqray. And we see really continued strong momentum and uptake in Rx. I mean, as you say, testing is critical, and we believe it's realistic also, particularly in Foundation Medicine, a plasma test to be approved in Q2, that we will reach these numbers and testing will continue.

    是的。非常感謝 Emmanuel 的提問。所以我們實際上對 Piqray 的性能非常滿意。我們看到 Rx 確實持續強勁的勢頭和吸收。我的意思是,正如你所說,測試至關重要,我們相信這也是現實的,特別是在 Foundation Medicine 中,這是一項將於第二季度獲得批准的血漿測試,我們將達到這些數字並且測試將繼續進行。

  • Maybe just a quick comment on the Akt inhibitors. I mean we have to be clear, it's a fundamentally different MOA. So it's really a very different mode of action. And just not to go too much into science, PI3K is mechanistically upstream of Akt, so we would expect a potential greater inhibition of the pathway. And just to emphasize, there is no, study as far as we know with an Akt inhibitor specifically designed for PIK3CA mutation cohort. And so far, Piqray is the only product approved for patients with this specific mutation. So we still remain very confident with Piqray and very optimistic.

    也許只是對 Akt 抑製劑的快速評論。我的意思是我們必須清楚,這是一個根本不同的 MOA。所以這真的是一種非常不同的行動方式。只是不要過多地研究科學,PI3K 在機制上位於 Akt 的上游,因此我們預計該途徑可能會受到更大的抑制。只是強調一下,據我們所知,沒有專門為 PIK3CA 突變隊列設計的 Akt 抑製劑進行的研究。到目前為止,Piqray 是唯一獲批用於具有這種特定突變的患者的產品。所以我們仍然對 Piqray 非常有信心並且非常樂觀。

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • And we don't have -- we've already, I think, completed earlier-stage studies of combinations of our PI3 kinase with CDK 4/6 and aromatase inhibitors and are not taking forward that combination as part of the EPIC program. With respect to BD, we are continuing our business development program. Capital allocation priorities remain in place. You've seen us conduct early stage deals out of NIBR, our research unit, over the course of the first quarter.

    而且我們沒有——我認為,我們已經完成了我們的 PI3 激酶與 CDK 4/6 和芳香酶抑製劑組合的早期研究,並且沒有將這種組合作為 EPIC 計劃的一部分。關於 BD,我們正在繼續我們的業務發展計劃。資本配置優先事項仍然存在。您已經看到我們在第一季度與我們的研究部門 NIBR 進行了早期交易。

  • So we continue to look at business development opportunities that fit our overall profile. I think, overall, as you can imagine, with the current turmoils in the market, there is a sector-wide decline in M&A activity. And I think that's going to be true for the foreseeable future until things stabilize a bit more. But I think from a business development and licensing standpoint, still active and remains a lot of opportunity. And on inclisiran primary care, Marie-France?

    因此,我們將繼續尋找適合我們整體形象的業務發展機會。我認為,總體而言,正如您可以想像的那樣,在當前市場動蕩的情況下,整個行業的併購活動都在下降。而且我認為在可預見的未來這將是真的,直到事情更加穩定為止。但我認為從業務發展和許可的角度來看,它仍然很活躍,並且仍然有很多機會。在 inclisiran 初級保健方面,Marie-France?

  • Marie-France Tschudin - President of Novartis Pharmaceuticals

    Marie-France Tschudin - President of Novartis Pharmaceuticals

  • Yes. Just to say that clearly we see a lot of synergies with Entresto. We'll have a very clear focus on cardiology, lipid clinics but also looking at government and systems of care.

    是的。只是說清楚,我們看到了與 Entresto 的很多協同作用。我們將非常明確地關注心髒病學、脂質診所,但也會關注政府和護理系統。

  • Operator

    Operator

  • Last question comes from the line of Kerry Holford from Berenberg.

    最後一個問題來自 Berenberg 的 Kerry Holford。

  • Kerry Holford;Berenberg;Head of Global Pharmaceutical Equity Research

    Kerry Holford;Berenberg;Head of Global Pharmaceutical Equity Research

  • Just one left, COVID-related. Vas, you mentioned briefly earlier, I wonder if you can help us understand the potential risk to the (inaudible) from the rising U.S. unemployment. Where do you see those risk across your portfolio? I know in relative terms, you have a lower exposure to the U.S. But it's good to get your thoughts on where there could be a pockets of risk. And if you're able, can you remind us of the broad split of your U.S. sales base by channel?

    只剩下一個,與 COVID 相關。 Vas,您之前簡要提到過,我想知道您是否可以幫助我們了解美國失業率上升對(聽不清)的潛在風險。您在哪裡看到您的投資組合中的這些風險?我知道,相對而言,您在美國的風險敞口較低。但最好了解一下可能存在風險的地方。如果可以的話,您能否提醒我們您的美國銷售基礎按渠道劃分的廣泛分佈?

  • Vasant Narasimhan - CEO

    Vasant Narasimhan - CEO

  • Well, thanks, Kerry. So on U.S. unemployment, I mean I think -- first, I think, of course, we're all saddened to see the incredible tide of rising unemployment in the United States and around the world. So I think this will, of course, have disruptions to the provision of health insurance. I think it's important to note there's a lot of uncertainties right now. First, of course, extended coverage through COBRA and similar policy initiatives. Second is the ability of patients to potentially get coverage through the various care consortia that now exists in states through Obamacare and then ultimately, to see how many patients move on to Medicaid. Then there's an additional dynamic that different products have different exposure in terms of the rebate gap between what we have in the private markets and in Medicaid and related segments.

    好吧,謝謝,克里。所以關於美國的失業率,我的意思是我認為——首先,我認為,當然,我們都為看到美國和世界各地令人難以置信的失業率上升趨勢感到難過。因此,我認為這當然會干擾醫療保險的提供。我認為重要的是要注意現在有很多不確定性。首先,當然是通過 COBRA 和類似的政策舉措擴大覆蓋範圍。其次是患者有能力通過奧巴馬醫改目前存在於各州的各種護理聯盟獲得保險,然後最終查看有多少患者進入醫療補助計劃。然後還有一個額外的動態,即不同的產品在我們在私人市場和醫療補助及相關細分市場之間的回扣差距方面有不同的風險敞口。

  • Newer products have, of course, a much smaller split because there have been fewer price increases. Older products, of course, have a much bigger gap in terms of differences on gross to net. So all of these dynamics are in there. Overall, I would say, we don't expect significant impacts in 2020. If we saw impacts, that would be in 2021. And we expect those impacts to be limited based on all of the assessments that we've done. I don't have a specific breakout in hand. But we view this as a manageable topic. We, of course, monitor it, doing all the assessments. But from what we can tell within our portfolio, worth noting, we're roughly 1/3 U.S., the remainder ex U.S. Within our U.S. business, lots of new product launches. And within our overall portfolio, relatively limited exposure to Medicaid versus our peer set.

    當然,較新的產品的價格漲幅要小得多,因為價格上漲幅度較小。當然,舊產品在總淨額差異方面的差距要大得多。所以所有這些動態都在那裡。總的來說,我想說的是,我們預計 2020 年不會產生重大影響。如果我們看到影響,那將是 2021 年。根據我們所做的所有評估,我們預計這些影響是有限的。我手頭沒有具體的突破。但我們認為這是一個可以管理的話題。當然,我們會對其進行監控,並進行所有評估。但是從我們的投資組合中可以看出,值得注意的是,我們大約有 1/3 是美國的,其餘的在美國之前在我們的美國業務中,有很多新產品發布。在我們的整體投資組合中,與同行相比,醫療補助的敞口相對有限。

  • Good. So thank you all for joining. Apologies we went a few minutes late. We hope you found the updates informative. Thank you for investing in Novartis, and we'll look forward to keeping you updated in the year to come. Please stay safe and healthy, and wish you all the best.

    好的。所以感謝大家的加入。抱歉,我們遲到了幾分鐘。我們希望您發現更新內容豐富。感謝您投資諾華,我們期待在來年為您提供最新信息。請保持安全和健康,並祝您一切順利。

  • Operator

    Operator

  • This concludes the conference for today. Thank you for participating. You may all disconnect.

    今天的會議到此結束。感謝您的參與。你們都可以斷開連接。