諾和諾德 (NVO) 2022 Q4 法說會逐字稿

內容摘要

諾和諾德是一家專注於糖尿病護理和治療的全球製藥公司。公司建立在三大支柱之上:創新、運營和業務發展。該公司對創新的關注導致許多新的和改進的產品被推向市場,這反過來又推動了增長和擴張。諾和諾德一直在尋找新的機會來發展業務並讓更多人接觸到其產品。

該公司預計將持續存在周期性供應限制和藥品短缺,以及對其產品的需求增加。他們正在逐步增加供應能力,但這不足以滿足所有預期需求。儘管有一些負面影響,例如收購 Forma Therapeutics,他們預計營業利潤仍會增長。他們的金融項目預計會產生淨收益,並且他們希望擁有強勁的自由現金流。

在去年分享了非常令人興奮的 II 期結果之後,諾和諾德預計在 2023 年下半年啟動 CagriSema 的 III 期計劃。此外,該公司已經完成了 ONWARDS 1 和 6 胰島素 icodec 試驗的26周安全擴展階段。結果證實,icodec 胰島素有可能成為 2 型糖尿病患者的理想胰島素,而 1 型糖尿病患者仍有更多評估要做。諾和諾德預計將在 2023 年上半年提交胰島素 icodec 進行監管審查。

在肥胖方面,諾和諾德期待分享每日一次口服 semaglutide 50 毫克的 III 期結果,期望達到與 [OI] 相當的療效和安全水平。在獲得結果之前,這將增加公司的肥胖治療產品組合,以解決許多肥胖患者仍然存在的重大未滿足需求。

此外,諾和諾德期待在 2023 年年中分享正在進行的 SELECT 心血管結局試驗的結果。在罕見病領域,該公司期待監管機構就每週一次的 Sogroya 治療生長激素缺乏症做出決定。與每天使用 Norditropin 相比,這將減輕治療負擔,並且是一種易於患者使用的設備。諾和諾德是一家全球領先的醫療保健公司,致力於改善糖尿病、肥胖症、罕見血液病和內分泌失調等嚴重慢性病患者的生活。 2022 年,在 GLP-1 產品銷售額增長 57% 的推動下,諾和諾德糖尿病護理的全球銷售額增長了 10%。諾和諾德以 64% 的全球市場份額保持 GLP-1 產品的市場領先地位。 Ozempic 繼續擴大其在 GLP-1 市場的份額,市場份額約為 43%。雖然 GLP-1 類藥物的增長率超過 50%,但 GLP-1 的滲透率仍然很低,僅佔全球糖尿病患者總數的 5% 左右。

與 2021 年相比,Rybelsus 的銷售額增長了一倍多。增長主要是由新產品的推出和銷量的增加推動的,這使得 Rybelsus 成為 2022 年僅次於 Ozempic 的第二大增長貢獻者。在日本、意大利和西班牙等主要市場的推出推動了國際業務的增長勢頭。

在美國,與 2021 年第四季度相比,2022 年第四季度的 GLP-1 市場容量增長了約 50%。最近推出的 GLP-1 競爭產品支持了市場增長的持續加速。以處方藥總量計算,諾和諾德以超過50%的市場份額保持市場份額領先地位。

諾和諾德是一家全球領先的醫療保健公司,致力於改善糖尿病、肥胖症、罕見血液病和內分泌失調等嚴重慢性病患者的生活。 2022 年,在 GLP-1 產品銷售額增長 57% 的推動下,諾和諾德糖尿病護理的全球銷售額增長了 10%。諾和諾德以 64% 的全球市場份額保持 GLP-1 產品的市場領先地位。 Ozempic 繼續擴大其在 GLP-1 市場的份額,市場份額約為 43%。雖然 GLP-1 類藥物的增長率超過 50%,但 GLP-1 的滲透率仍然很低,僅佔全球糖尿病患者總數的 5% 左右。

與 2021 年相比,Rybelsus 的銷售額增長了一倍多。增長主要是由新產品的推出和銷量的增加推動的,這使得 Rybelsus 成為 2022 年僅次於 Ozempic 的第二大增長貢獻者。在日本、意大利和西班牙等主要市場的推出推動了國際業務的增長勢頭。

在美國,與 2021 年第四季度相比,2022 年第四季度的 GLP-1 市場容量增長了約 50%。最近推出的 GLP-1 競爭產品支持了市場增長的持續加速。以處方藥總量計算,諾和諾德以超過50%的市場份額保持市場份額領先地位。諾和諾德是一家丹麥製藥公司,近年來取得了很大的成功,其肥胖護理銷售額增長了 84%。這一成功的主要原因是 Wegovy 在丹麥和挪威的推出,以及 Saxenda 在國際業務中的表現。在美國,肥胖護理銷售額增長了 90%,其中 Wegovy 和 Saxenda 都為增長做出了貢獻。 2022 年 12 月,美國再次提供了 Wegovy 的所有劑量強度。在短短幾週內,Wegovy 處方趨勢加速並已達到歷史最高水平。這種吸收強調了肥胖患者的重大未滿足需求。許多患者一直在等待所有劑量的 Wegovy 再次上市,這造成了被壓抑的需求。

諾和諾德是一家專注於糖尿病護理的全球醫療保健公司。 95 多年來,該公司一直在該領域保持創新和領先地位。諾和諾德在血友病、生長激素紊亂和激素替代療法方面擁有強大的地位。該公司在 79 個國家/地區擁有 43,100 名員工,產品銷往 170 多個國家/地區。

2021年,諾和諾德收購了專門從事基於RNA的研發的公司Dicerna Pharmaceuticals。此次收購使諾和諾德能夠啟動非酒精性脂肪性肝炎 (NASH)(一種脂肪性肝病)新療法的兩項 I 期臨床試驗。

I 期試驗的主要目標是評估新療法的安全性和耐受性,以及它們的藥代動力學和藥效學特徵。臨床試驗的啟動證明了 Dicerna 基於 RNA 的研發已成功整合到諾和諾德。

諾和諾德期待著激動人心的 2023 年,預計今年上半年將公佈幾項重要的 III 期臨床試驗數據。其中包括每天一次口服 semaglutide 25 mg 和 50 mg 治療糖尿病的試驗。為期 68 週的試驗的主要終點是確認口服 semaglutide 25 mg 和 50 mg 優於口服 semaglutide 14 mg 在降低 A1C 方面的優勢。該公司預計新療法將達到與 Ozempic 相當的療效和安全性。

諾和諾德是一家丹麥製藥公司,近年來取得了巨大成功,其肥胖護理銷售額增長了 84%。這一成功的主要原因是 Wegovy 在丹麥和挪威的推出,以及 Saxenda 在國際業務中的表現。在美國,肥胖護理銷售額增長了 90%,其中 Wegovy 和 Saxenda 都為增長做出了貢獻。 2022 年 12 月,美國再次提供了 Wegovy 的所有劑量強度。在短短幾週內,Wegovy 處方趨勢加速並已達到歷史最高水平。這種吸收強調了肥胖患者的重大未滿足需求。許多患者一直在等待所有劑量的 Wegovy 再次上市,這造成了被壓抑的需求。

諾和諾德是一家專注於糖尿病護理的全球醫療保健公司。 95 多年來,該公司一直在該領域保持創新和領先地位。諾和諾德在血友病、生長激素紊亂和激素替代療法方面擁有強大的地位。該公司在 79 個國家/地區擁有 43,100 名員工,產品銷往 170 多個國家/地區。

2021年,諾和諾德收購了專門從事基於RNA的研發的公司Dicerna Pharmaceuticals。此次收購使諾和諾德能夠啟動非酒精性脂肪性肝炎 (NASH)(一種脂肪性肝病)新療法的兩項 I 期臨床試驗。

I 期試驗的主要目標是評估新療法的安全性和耐受性,以及它們的藥代動力學和藥效學特徵。臨床試驗的啟動證明了 Dicerna 基於 RNA 的研發已成功整合到諾和諾德。

諾和諾德期待著激動人心的 2023 年,預計今年上半年將公佈幾項重要的 III 期臨床試驗結果。其中包括每天一次口服 semaglutide 25 mg 和 50 mg 治療糖尿病的試驗。為期 68 週的試驗的主要終點是確認口服 semaglutide 25 mg 和 50 mg 優於口服 semaglutide 14 mg 在降低 A1C 方面的優勢。該公司預計新療法將達到與 Ozempic 相當的療效和安全性。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good day and thank you for standing by. Welcome to the Q4 2022 Novo Nordisk A/S Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lars Fruergaard Jorgensen, CEO. Please go ahead.

    美好的一天,謝謝你的支持。歡迎參加 Novo Nordisk A/S 2022 年第四季度收益電話會議。 (操作員說明)請注意,今天的會議正在錄製中。我現在想把會議交給今天的演講者,首席執行官 Lars Fruergaard Jorgensen。請繼續。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, operator. Welcome to this Novo Nordisk Earnings call for the full year of 2022 and the outlook for 2023. My name is Lars Fruergaard Jorgensen, and I'm the CEO of Novo Nordisk. With me today, I have Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvest;, Executive Vice President and Head of North America Operations, Doug Langa; Executive Vice President and Head of Development, Martin Holst Lange; and finally, Chief Financial Officer Karsten Munk Knudsen. All of us would be available for the Q&A session.

    謝謝你,運營商。歡迎來到諾和諾德 2022 年全年和 2023 年展望的財報電話會議。我叫 Lars Fruergaard Jorgensen,是諾和諾德的首席執行官。今天和我在一起的有執行副總裁兼商業戰略和公司事務主管 Camilla Sylvest;執行副總裁兼北美運營主管 Doug Langa;執行副總裁兼研發主管 Martin Holst Lange;最後,首席財務官 Karsten Munk Knudsen。我們所有人都可以參加問答環節。

  • Today's announcement and the slides for this call are available on our website, novonordisk.com. Please note that the call is being webcasted live, and a recording will be made available on our website as well. This call is scheduled to last 1 hour.

    今天的公告和本次電話會議的幻燈片可在我們的網站 novonordisk.com 上獲取。請注意,電話會議正在網絡直播,我們的網站上也會提供錄音。此通話計劃持續 1 小時。

  • Please turn to the next slide. The presentation is structured as outlined on Slide 2. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.

    請翻到下一張幻燈片。演示文稿的結構如幻燈片 2 所述。請注意,除非另有說明,否則所有銷售和營業利潤增長報表均採用固定匯率。

  • Please turn to Slide 3. As always, I need to advise you that this call will contain forward-looking statements. These are subject to risks and uncertainties that could cause actual results to differ materially from expectations. For further information on the risk factors, please see the company announcement for the full year of 2022 and the slides prepared for this presentation.

    請轉到幻燈片 3。與往常一樣,我需要通知您,本次電話會議將包含前瞻性陳述。這些受到風險和不確定性的影響,可能導致實際結果與預期存在重大差異。有關風險因素的更多信息,請參閱公司 2022 年全年公告和為本演示文稿準備的幻燈片。

  • Please turn to the next slide. In 2022, we delivered double-digit sales growth and operating profit growth, and we continue to make progress on our strategic aspirations. I'd like to go through the highlights before handing over the word to my colleagues. We continue to make progress across all dimensions of purpose and sustainability. Our carbon emissions decreased by 29% compared to pre-pandemic levels in 2019, and we continue to reach even more patients and patients living with diabetes compared to last year.

    請翻到下一張幻燈片。 2022 年,我們實現了兩位數的銷售增長和營業利潤增長,我們繼續在實現戰略目標方面取得進展。在將消息交給我的同事之前,我想先過一遍要點。我們繼續在目標和可持續性的各個方面取得進展。與 2019 年大流行前的水平相比,我們的碳排放量減少了 29%,與去年相比,我們繼續惠及更多的患者和糖尿病患者。

  • In line with our aspiration of being a sustainable employer, we expanded the number of women in leadership positions to 39% compared to 36% in 2021. Within R&D, we are pleased that we now have initiated the first 2 Phase I trials based on the Dicerna, in the siRNA technology platform that we acquired in 2021. Looking back at 2022, we have seen exciting trial readouts across all our therapy areas. And in 2023, we look forward to having an equally exciting year. Martin will come back to this and our overall R&D milestones later.

    為了實現我們成為可持續雇主的願望,我們將擔任領導職位的女性人數從 2021 年的 36% 增加到了 39%。在研發方面,我們很高興現在已經啟動了第一階段的前 2 期試驗,該試驗基於Dicerna,在我們於 2021 年收購的 siRNA 技術平台中。回顧 2022 年,我們在所有治療領域都看到了令人興奮的試驗結果。在 2023 年,我們期待同樣激動人心的一年。 Martin 稍後會回到這一點以及我們的整體研發里程碑。

  • In 2022, we delivered double-digit sales growth, reflecting strong commercial execution in core geographies and our therapy areas. Our both operating units contributed to sales growth, we saw a particular strong sales growth in North America, driven by accelerated demand for our GLP-1 treatments for both diabetes and obesity. Camilla and Doug will go through the details for therapy area later. Karsten will go through the financials, but I'm very pleased with the sales growth of 16% and operating profit growth of 15% in 2022.

    2022 年,我們實現了兩位數的銷售額增長,反映出我們在核心地區和治療領域的強大商業執行力。我們的兩個運營部門都為銷售增長做出了貢獻,我們在北美看到了特別強勁的銷售增長,這是由於對我們治療糖尿病和肥胖症的 GLP-1 療法的需求加速增長。卡米拉和道格稍後會詳細介紹治療區域。 Karsten 將審閱財務報告,但我對 2022 年 16% 的銷售額增長和 15% 的營業利潤增長感到非常滿意。

  • Lastly, I have a brief update on our strategic aspirations within financials. We have achieved the U.S. aspiration of converting 70% of sales through products launched since 2015 and IO sales growth has in the last couple of years, surpassed aspiration of 6% to 10% growth. Consequently, we have decided to remove these regional iterations. Going forward, we'll be focused on and committed to delivering solid sales and operating profit growth.

    最後,我簡要介紹一下我們在金融領域的戰略目標。我們已經實現了美國的願望,即通過 2015 年以來推出的產品轉化 70% 的銷售額,並且 IO 銷售額在過去幾年中的增長超過了 6% 至 10% 的增長目標。因此,我們決定刪除這些區域迭代。展望未來,我們將專注於並致力於實現穩健的銷售和營業利潤增長。

  • With that, I'll give the word to Camilla for an update on execution.

    有了這個,我會告訴卡米拉關於執行的最新消息。

  • Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

    Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

  • Thank you, Lars, and please turn to the next slide. As Lars mentioned, our 16% sales growth for the full year of 2022 was driven by both operating units with North America operations growing by 21% and international operations growing 13%. The strong sales growth has unfortunately resulted in periodic supply constraints and related stock shortage notifications across a number of products and geographies.

    謝謝 Lars,請翻到下一張幻燈片。正如 Lars 所提到的,我們 2022 年全年 16% 的銷售額增長是由北美業務增長 21% 和國際業務增長 13% 的兩個運營部門推動的。不幸的是,強勁的銷售增長導致了一些產品和地區的周期性供應限制和相關的庫存短缺通知。

  • Our GLP-1 sales increased by 42%, driven by North America growing 36% and international operations growing 57%. Insulin sales decreased by 11%, driven by a 7% decline in international operations and a 21% sales decline in North America operations. The U.S. insulin sales declined by 22%. This was driven by lower realized prices as well as a decline in volume. Compared to 2021, the U.S. insulin volume market declined by 3%. Furthermore, insulin sales in international operations were impacted by the implementation of volume-based procurement in China, starting in May 2022 and lower sales in EMEA.

    在北美增長 36% 和國際業務增長 57% 的推動下,我們的 GLP-1 銷售額增長了 42%。受國際業務下降 7% 和北美業務下降 21% 的推動,胰島素銷售額下降了 11%。美國胰島素銷售額下降了 22%。這是由較低的實際價格和銷量下降推動的。與 2021 年相比,美國胰島素銷量市場下降了 3%。此外,國際業務的胰島素銷售受到從 2022 年 5 月開始在中國實施批量採購以及 EMEA 銷售額下降的影響。

  • Obesity care sales grew by 84% overall. In International Operations, sales grew by 82%. And in North America Operations, Obesity care sales grew 85%. In the U.S., Obesity Care sales grew by 90%.

    肥胖護理銷售額總體增長了 84%。在國際業務方面,銷售額增長了 82%。在北美業務中,肥胖症護理銷售額增長了 85%。在美國,肥胖護理的銷售額增長了 90%。

  • Rare Disease sales grew 1%, driven by a 5% sales increase in international operations, offset by a 5% decline in North America operations.

    罕見病銷售額增長 1%,受國際業務銷售額增長 5% 的推動,被北美業務下降 5% 所抵消。

  • Please turn to Slide 6. Our 14% sales growth within Diabetes Care continues to be higher than the overall diabetes market. That means we have improved our market share by 1.8 percentage points to 31.9%. We continue to be on track to reach 1/3 of the diabetes value market by 2025. This increase primarily reflects GLP-1 market growth as well as share gains in both operating units.

    請轉到幻燈片 6。我們在糖尿病護理領域 14% 的銷售額增長繼續高於整個糖尿病市場。這意味著我們的市場份額提高了 1.8 個百分點,達到 31.9%。我們繼續有望到 2025 年達到糖尿病價值市場的 1/3。這一增長主要反映了 GLP-1 市場的增長以及兩個運營部門的份額增長。

  • Please turn to the next slide. International Operations' Diabetes Care sales increased by 10% in 2022, driven by GLP-1 sales growing by 57%. Novo Nordisk remains the market leader in international operations with a GLP-1 value market share of 64%. This is driven by share gains across geographies. Ozempic continues to expand its GLP-1 market share leadership in international operations with around 43% market share. While the GLP-1 class growth is more than 50%, GLP-1 penetration remains low at around 5% of total diabetes patients globally.

    請翻到下一張幻燈片。在 GLP-1 銷售額增長 57% 的推動下,國際運營部的糖尿病護理銷售額在 2022 年增長了 10%。諾和諾德仍然是國際業務的市場領導者,GLP-1 價值市場份額為 64%。這是由跨地區的份額增長推動的。 Ozempic 繼續擴大其在國際業務中的 GLP-1市場份額領導地位,市場份額約為 43%。雖然 GLP-1 類藥物的增長率超過 50%,但 GLP-1 的滲透率仍然很低,僅佔全球糖尿病患者總數的 5% 左右。

  • Rybelsus sales more than doubled compared to 2021. The growth was mainly driven by new launches and increasing volumes, making Rybelsus the second largest growth contributor in 2022 after Ozempic. The increased momentum in international operation is driven by launches in key markets such as Japan, Italy and Spain.

    與 2021 年相比,Rybelsus 的銷售額增長了一倍多。增長主要是由新產品的推出和銷量的增加推動的,這使得 Rybelsus 成為 2022 年僅次於 Ozempic 的第二大增長貢獻者。在日本、意大利和西班牙等主要市場的推出推動了國際業務的增長勢頭。

  • And with that, I will hand over the word to Doug.

    有了這個,我會把這個詞交給道格。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Thank you for that update, Camilla. Please turn to the next slide. The U.S. GLP-1 market volume grew by around 50%, comparing the fourth quarter of 2022 to the fourth quarter of 2021. The recent competitor launch in GLP-1 has supported the continued acceleration in market growth and from an NBRx perspective, we continue to see all-time high levels of new patients starting on our portfolio of GLP-1 products on the end of 2022. Measured on total prescriptions, Novo Nordisk has maintained its market share leadership with a market share of more than 50%.

    謝謝你的更新,卡米拉。請翻到下一張幻燈片。與 2022 年第四季度和 2021 年第四季度相比,美國 GLP-1 市場容量增長了約 50%。最近推出的 GLP-1 競爭對手支持了市場增長的持續加速,從 NBRx 的角度來看,我們繼續到 2022 年底,開始使用我們的 GLP-1 產品組合的新患者數量創歷史新高。按總處方計算,諾和諾德以超過 50% 的市場份額保持其市場份額領先地位。

  • Please go to the next slide. Obesity care sales increased by 84%, with 85% growth in North America operations and 82% in international operations. The global branded obesity market expansion continues with a volume growth of more than 50%. We are excited that Wegovy is now launched in Denmark and Norway, the first 2 markets outside of the U.S. But we also remain encouraged by the performance of Saxenda in international operations. Region EMEA is the key growth driver with 96% growth in 2022. In the U.S., Obesity care sales grew 90% with both Wegovy and Saxenda contributing to growth. All dose strengths of Wegovy were made available in the U.S., again in December of 2022. And in only a few weeks, Wegovy prescription trends have accelerated and already reached all-time high levels.

    請轉到下一張幻燈片。肥胖護理銷售額增長了 84%,北美業務增長了 85%,國際業務增長了 82%。全球品牌肥胖市場繼續擴張,銷量增長超過 50%。我們很高興 Wegovy 現在在丹麥和挪威推出,這是美國以外的前兩個市場。但我們也對 Saxenda 在國際業務中的表現感到鼓舞。 EMEA 地區是主要的增長動力,到 2022 年將增長 96%。在美國,肥胖護理銷售額增長了 90%,Wegovy 和 Saxenda 都為增長做出了貢獻。 2022 年 12 月,美國再次提供了 Wegovy 的所有劑量強度。在短短幾週內,Wegovy 處方趨勢加速並已達到歷史最高水平。

  • The uptake underlines the significant unmet need for patients with obesity. Many patients have been waiting for all doses of Wegovy to be available again, which has created a pent-up demand. We are now looking forward to continuing the relaunch of Wegovy.

    這種吸收強調了肥胖患者的重大未滿足需求。許多患者一直在等待所有劑量的 Wegovy 再次上市,這造成了被壓抑的需求。我們現在期待著繼續重新啟動 Wegovy。

  • Now back to Camilla for an update on rare disease.

    現在回到卡米拉,了解有關罕見病的最新消息。

  • Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

    Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

  • Thank you, Doug. And next slide, please. Our rare disease sales increased by 1% in 2022. This was driven by a 5% sales growth in international operations, offset by a 5% decline in North America provisions, where blood disorders grew by 7%, driven by NovoSeven as well as the launch products, Esperoct and Refixia. Specifically, hemophilia A products grew by 6%, hemophilia B sales by 16% and NovoSeven by 6%, rare endocrine disorder sales declined by 6%. The declining sales were driven by international operations decreasing 1% and by North America operations decreasing by 18%. The sales were negatively impacted by lower realized prices in the U.S. as well as the supply constraints in the fourth quarter of 2022.

    謝謝你,道格。請切換到下一張幻燈片。我們的罕見病銷售額在 2022 年增長了 1%。這是由國際業務銷售額增長 5% 所推動,但被北美供應下降 5% 所抵消,北美供應下降 7%,受 NovoSeven 和推出產品 Esperoct 和 Refixia。具體而言,血友病 A 產品增長 6%,血友病 B 銷售額增長 16%,NovoSeven 銷售額增長 6%,罕見內分泌疾病銷售額下降 6%。銷售額下降的原因是國際業務下降了 1%,北美業務下降了 18%。銷售受到美國較低的實際價格以及 2022 年第四季度的供應限制的負面影響。

  • And now over to you, Martin, for an update on R&D.

    現在輪到你了,馬丁,關於研發的最新消息。

  • Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

    Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

  • Thank you, Camilla. Please turn to Slide 11. Firstly, I'm very happy to be able to share that we have initiated 2 Phase I trials within NASH. This is particularly exciting because the 2 assets are both based on the small interfering RNA technology that we acquired as part of the Dicerna acquisition back in 2021. Both trials are 52-week trials and target LXR and MARC1, respectively. Both assets are aiming for long-term NASH resolution and fibrosis improvement with monthly or even less frequent dosing.

    謝謝你,卡米拉。請轉到幻燈片 11。首先,我很高興能夠分享我們已經在 NASH 中啟動了 2 個 I 期試驗。這特別令人興奮,因為這兩項資產均基於我們在 2021 年作為 Dicerna 收購的一部分獲得的小干擾 RNA 技術。兩項試驗均為 52 週試驗,分別針對 LXR 和 MARC1。這兩項資產的目標是通過每月或什至更不頻繁的給藥來長期解決 NASH 和改善纖維化。

  • The objective of both Phase I trials is to investigate the safety, tolerability and PK/PD profile of each asset respectively. The fact that we have now initiated these trials is a testimony to the successful integration and fast progression of the RNA-based research and development in Novo Nordisk. As mentioned at our Capital Markets Day in March of last year, our ambition is to generate an annual average of 3 first human doses across therapy areas based on the RNA technology over the next 10 years.

    這兩項 I 期試驗的目的是分別研究每種資產的安全性、耐受性和 PK/PD 概況。我們現在啟動這些試驗的事實證明了諾和諾德基於 RNA 的研發的成功整合和快速進展。正如我們在去年 3 月的資本市場日提到的那樣,我們的目標是在未來 10 年內基於 RNA 技術在治療領域平均每年產生 3 劑第一劑人體疫苗。

  • Please turn to the next slide. We're looking forward to a very exciting 2023 with many important Phase III trial readouts across our therapy areas. I would like to briefly go through a few highlights. We then have 2 diabetes we expect to see results from the Phase III trial PIONEER PLUS with once-daily oral semaglutide 25 milligram and 50 milligram, respectively, during the first half of 2023. The primary endpoint of the 68-week trial is to confirm superiority of oral semaglutide 25 milligram and 50 milligram versus oral semaglutide 14 milligram on A1C reduction. The expectation is to reach an efficacy and safety profile comparable to that of Ozempic.

    請翻到下一張幻燈片。我們期待著一個非常激動人心的 2023 年,我們的治療領域將有許多重要的 III 期試驗讀數。我想簡要介紹幾個要點。然後我們患有 2 型糖尿病,我們希望在 2023 年上半年看到每天一次口服 semaglutide 25 毫克和 50 毫克的 III 期試驗 PIONEER PLUS 的結果。為期 68 週的試驗的主要終點是確認口服 semaglutide 25 毫克和 50 毫克與口服 semaglutide 14 毫克相比在降低 A1C 方面的優勢。期望達到與 Ozempic 相當的療效和安全性。

  • Also in diabetes, we expect to initiate the Phase III program with CagriSema in the second half of 2023, following the very exciting Phase II results that we shared last year. Furthermore, we have completed the 26-week safety extension phases for the ONWARDS 1 and 6 trials with insulin icodec. The results confirm that insulin icodec has the potential to be the ideal for -- insulin for people with type 2 diabetes, while there are still more assessments to be done in type 1 diabetes. We expect to submit insulin icodec for a regulatory review in the first half of 2023.

    同樣在糖尿病方面,我們預計在我們去年分享了非常令人興奮的 II 期結果之後,將於 2023 年下半年與 CagriSema 啟動 III 期計劃。此外,我們已經完成了 ONWARDS 1 和 6 胰島素 icodec 試驗的 26 周安全擴展階段。結果證實,胰島素 icodec 有可能成為 2 型糖尿病患者的理想胰島素,而 1 型糖尿病患者仍有更多評估要做。我們預計在 2023 年上半年提交胰島素 icodec 進行監管審查。

  • In obesity, we look forward to sharing the Phase III results from once daily oral semaglutide type 50 milligram, where our expectation is to reach a level of efficacy and safety comparable to that [OI]. Pending the results, this would add to our portfolio of obesity treatments to address the significant unmet need that remains for many patients with obesity.

    在肥胖方面,我們期待分享每日一次口服 semaglutide 50 毫克的 III 期結果,我們期望達到與 [OI] 相當的療效和安全水平。在等待結果之前,這將增加我們的肥胖治療組合,以解決許多肥胖患者仍然存在的重大未滿足需求。

  • Furthermore, we look forward to sharing the results from the ongoing SELECT cardiovascular outcomes trial in the middle of 2023. Within rare disease, we are looking forward to a decision from regulatory authorities on once weekly Sogroya for the treatment of growth hormone deficiency. This will offer a reduced treatment burden compared to daily Norditropin and a device that is easy to use for patients.

    此外,我們期待在 2023 年年中分享正在進行的 SELECT 心血管結局試驗的結果。在罕見疾病中,我們期待監管機構就每週一次的 Sogroya 治療生長激素缺乏症做出決定。與每天使用 Norditropin 相比,這將減輕治療負擔,並且是一種易於患者使用的設備。

  • Finally, we expect to initiate a Phase IIIb trial with Ziltivekimab for the treatment of heart failure with preserved ejection fraction in the first half of 2023. Altogether, we are looking forward to a very exciting year with clinical trial initiations as well as results across our therapy areas.

    最後,我們預計在 2023 年上半年啟動 Ziltivekimab 治療射血分數保留的心力衰竭的 IIIb 期試驗。總而言之,我們期待著非常激動人心的一年,臨床試驗的啟動以及我們的結果治療領域。

  • With that, over to you, Karsten.

    有了這個,就交給你了,Karsten。

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Thank you, Martin. Please turn to the next slide. In 2022, our sales grew by 26% in Danish kroner and 16% at constant exchange rates, driven by both operating units. The gross margin increased to 83.9% compared to 83.2% in 2021, driven by a positive product mix due to increased GLP-1 sales, a positive currency impact and productivity improvements. Lower realized prices, particularly in the U.S. and China partially offset these effects. Sales and distribution costs increased by 25% in Danish kroner and 16% at constant exchange rates. The increase is driven by launch activities and promotional spend for Rybelsus and Ozempic, as well as market development activities for obesity. The cost increase is reflecting low activity levels in 2021 due to COVID-19 and higher distribution costs.

    謝謝你,馬丁。請翻到下一張幻燈片。 2022 年,在兩個運營部門的推動下,我們的銷售額以丹麥克朗計算增長了 26%,按固定匯率計算增長了 16%。毛利率從 2021 年的 83.2% 增至 83.9%,這得益於 GLP-1 銷量增加帶來的積極產品組合、積極的貨幣影響和生產力的提高。較低的實際價格,尤其是在美國和中國,部分抵消了這些影響。銷售和分銷成本以丹麥克朗計算增長了 25%,按固定匯率計算增長了 16%。這一增長是由 Rybelsus 和 Ozempic 的發布活動和促銷支出以及針對肥胖症的市場開發活動推動的。成本增加反映了 2021 年由於 COVID-19 和更高的分銷成本導致的低活動水平。

  • Research and development costs increased by 35% in Danish kroner and 29% at constant exchange rates. The increase is driven by higher clinical activity levels within other serious chronic diseases and GLP-1, as well as the operating costs and amortizations related to the acquisition of Dicerna Pharmaceuticals. We acquired Dicerna in the fourth quarter of '21.

    研發成本以丹麥克朗計算增加了 35%,按固定匯率計算增加了 29%。這一增長是由其他嚴重慢性疾病和 GLP-1的更高臨床活動水平,以及與收購 Dicerna Pharmaceuticals 相關的運營成本和攤銷推動的。我們在 21 年第四季度收購了 Dicerna。

  • Administration costs increased by 10% in Danish kroner and 6% at constant exchange rates. Operating profit increased by 28% in Danish kroner and by 15% at constant exchange rates. Net financial items for 2022 showed a loss of around DKK 6 billion compared to a gain of around DKK 0.4 billion in '21. This mainly relates to losses following the appreciation of the U.S. dollar as reflected in the favorable currency impact on operating profit.

    管理成本以丹麥克朗計算增加了 10%,按固定匯率計算增加了 6%。營業利潤以丹麥克朗計算增長 28%,按固定匯率計算增長 15%。 2022 年的淨金融項目顯示虧損約 60 億丹麥克朗,而 21 年則為盈利約 4 億丹麥克朗。這主要與美元升值後的損失有關,這反映在貨幣對營業利潤的有利影響上。

  • As per the end of December '22, a positive market value of financial contracts of approximately DKK 1 billion has been deferred for recognition in 2023. The effective tax rate in '22 was 19.6% compared to 19.2% in '21, mainly reflecting nonrecurring impacts from acquisitions. Net profit increased by 16% and diluted earnings per share increased by 18% to DKK 24 and EUR 44.

    截至 22 年 12 月末,約 10 億丹麥克朗的金融合同正市值已推遲到 2023 年確認。22 年的有效稅率為 19.6%,而 21 年為 19.2%,主要反映非經常性收購的影響。淨利潤增長 16%,稀釋後每股收益增長 18%,達到 24 丹麥克朗和 44 歐元。

  • Free cash flow was DKK 57.4 billion compared to DKK 29.3 billion in '21, supporting the strategic aspiration to deliver attractive capital allocation to shareholders. The cash conversion in '22 is positively impacted by timing of rebate payments in the U.S., including provisions related to the revised 340B distribution policy in the U.S. Income under the 340B program has been partially recognized.

    自由現金流為 574 億丹麥克朗,而 21 年為 293 億丹麥克朗,支持為股東提供有吸引力的資本配置的戰略願望。 22 年的現金轉換受到美國退稅支付時間的積極影響,包括與 340B 計劃下美國收入中修訂後的 340B 分配政策相關的規定已部分確認。

  • Please go to the next slide. In 2023, we expect to increase our capital expenditure to around DKK 25 billion. This is a significant step-up compared to 2022 and reflects the innovation-based growth strategy that we are pursuing in Novo Nordisk. The increase in capital expenditure mainly relates to investments in additional capacity for active pharmaceutical ingredient production and fill finish capacity for both current and future injectable and all products across therapy areas.

    請轉到下一張幻燈片。 2023 年,我們預計將資本支出增加到 250 億丹麥克朗左右。與 2022 年相比,這是一個重大進步,反映了我們在諾和諾德追求的基於創新的增長戰略。資本支出的增加主要涉及對活性藥物成分生產的額外產能以及當前和未來注射劑以及跨治療領域所有產品的填充完成能力的投資。

  • In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The investments will gradually add capacity, flexibility and resilience in our manufacturing setup while also accommodating for potential upsides to forecast.

    未來幾年,資本支出佔銷售額的比率預計將保持在兩位數的低水平。這些投資將逐步增加我們製造設施的產能、靈活性和彈性,同時也適應預測的潛在上行空間。

  • Next slide, please. In 2022, we returned more than [DKK 49 billion] to shareholders via dividends and share buybacks. Novo Nordisk has consistently returned its free cash flow to investors through both share buybacks and dividends. At the Annual General Meeting on March 23, 2023, the Board of Directors will propose a final dividend of DKK 8.15 for a total 2022 dividend of DKK 12.40, a 19% increase compared to 2021, making it the 27th consecutive year with increasing dividends.

    請換下一張幻燈片。 2022 年,我們通過股息和股票回購向股東返還了超過 [490 億丹麥克朗]。諾和諾德一直通過股票回購和派息向投資者返還其自由現金流。在 2023 年 3 月 23 日的年度股東大會上,董事會將提議派發 8.15 丹麥克朗的末期股息,2022 年總股息為 12.40 丹麥克朗,較 2021 年增長 19%,連續第 27 年增加股息。

  • In addition to the dividends, DKK 24 billion was used for repurchase of shares. For 2023, the Board of Directors has approved a new share repurchase program of up to DKK 28 billion to be executed during the coming 12 months.

    除股息外,還有240億丹麥克朗用於回購股份。對於 2023 年,董事會已批准一項高達 280 億丹麥克朗的新股票回購計劃,將在未來 12 個月內執行。

  • Next slide, please. We continue 2023 with solid growth momentum and expect the sales growth to be between 13% and 19% at constant exchange rates. This is based on several assumptions as described in the company announcement. The guidance reflects expectations for sales growth in both International Operations and North America operations, mainly driven by GLP-1 based treatments for diabetes and obesity care. The sales growth within diabetes and obesity care is expected to be partially countered by declining sales in rare disease due to supply constraints. The guidance ranges for sales and operating profit growth reflect the level of volume growth of GLP-1-based diabetes treatments. They also reflect the inherent uncertainty of the pace of obesity care market expansion following the relaunch of Wegovy in the U.S. and expected gradual rollout in international operations.

    請換下一張幻燈片。我們在 2023 年繼續保持穩健的增長勢頭,預計按固定匯率計算,銷售額增長將在 13% 至 19% 之間。這是基於公司公告中描述的幾個假設。該指引反映了對國際業務和北美業務銷售增長的預期,主要受基於 GLP-1 的糖尿病和肥胖症治療藥物的推動。糖尿病和肥胖症護理領域的銷售額增長預計將部分被供應限制導致的罕見疾病銷售額下降所抵消。銷售額和營業利潤增長的指導範圍反映了基於 GLP-1 的糖尿病治療藥物的銷量增長水平。它們還反映了在美國重新推出 Wegovy 後肥胖護理市場擴張步伐的內在不確定性,並預計將逐步推出國際業務。

  • The outlook includes an expectation of continued periodic supply constraints and related drug shortage notifications in 2023 across a number of products and geographies. This is driven by higher-than-expected volume growth for GLP-1 based products, such as Ozempic and temporary capacity limitations at some manufacturing sites. We are gradually increasing our supply capacity.

    展望包括預計 2023 年許多產品和地區將持續出現週期性供應限制和相關藥物短缺通知。這是由於基於 GLP-1 的產品(例如 Ozempic)的銷量增長高於預期以及一些生產基地的臨時產能限制。我們正在逐步增加我們的供應能力。

  • We expect that operating profit will grow between 13% and 19% on constant exchange rates. This primarily reflects the sales growth outlook and continued investments in current and future growth drivers within research, development and commercial. Commercial investments are mainly related to the relaunch of Wegovy in the U.S., obesity care market development activities in international operations as well as promotional activities for Ozempic and Rybelsus. The acquisition of Forma Therapeutics is negatively impacting the operating profit growth due to higher operating costs and amortizations.

    我們預計按固定匯率計算,營業利潤將增長 13% 至 19%。這主要反映了銷售增長前景以及對研究、開發和商業領域當前和未來增長動力的持續投資。商業投資主要涉及Wegovy在美國的重啟、國際運營中的肥胖護理市場開發活動以及Ozempic和Rybelsus的推廣活動。由於更高的運營成本和攤銷,收購 Forma Therapeutics 對運營利潤增長產生了負面影響。

  • Finally, the guidance also reflects inflationary impacts on the cost base. Given the current exchange rates, most notably a weakening of the U.S. dollar, we expect a negative currency impact for 2023. Our reported sales are expected to be 4 percentage points lower at CER and operating profit is expected to be 5 percentage points lower at CER. The negative currency impact on operating profit of 5 percentage points is partially offset by a net gain on financial items. We expect that financial items will amount to a net gain of around DKK 2.4 billion, mainly reflecting gains associated with foreign exchange hedging contracts. Capital expenditure is expected to be around DKK 25 billion in 2023, as I outlined earlier in this presentation. Our free cash flow is now expected to be between DKK 60 billion and DKK 68 billion, reflecting the sales growth and investments in capital expenditure.

    最後,該指南還反映了通貨膨脹對成本基礎的影響。鑑於當前的匯率,最顯著的是美元走弱,我們預計 2023 年貨幣將受到負面影響。我們報告的銷售額預計將按 CER 降低 4 個百分點,營業利潤預計將按 CER 降低 5 個百分點.貨幣對營業利潤 5 個百分點的負面影響被金融項目的淨收益部分抵消。我們預計金融項目將產生約 24 億丹麥克朗的淨收益,主要反映與外匯對沖合約相關的收益。 2023 年的資本支出預計將達到 250 億丹麥克朗左右,正如我在本演示文稿前面所述。我們的自由現金流現在預計在 600 億至 680 億丹麥克朗之間,反映了銷售增長和資本支出投資。

  • That covers the updated outlook for '23. Now back to you, Lars, for final remarks.

    這涵蓋了 23 年的最新展望。現在回到你,拉斯,最後的評論。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Karsten. Please turn to the final slide. We're very pleased with the double-digit sales growth for the full year of 2022 and that we continue to reach even more patients. 2023 is a truly significant year in history of Novo Nordisk as we celebrate our 100-year anniversary. In this period, we have grown from a small Danish company into a global one, developing life-saving medicines for millions of patients around the world.

    謝謝你,卡斯滕。請翻到最後一張幻燈片。我們對 2022 年全年兩位數的銷售額增長以及我們繼續接觸更多患者感到非常高興。 2023 年是諾和諾德歷史上真正重要的一年,因為我們慶祝成立 100 週年。在此期間,我們從一家小型丹麥公司發展成為一家全球性公司,為全球數百萬患者開發挽救生命的藥物。

  • In 2023, we look forward continuing our focus on commercial execution, expanding our pipeline and investing significantly in the expansion of production capacity for current and future products. With that we're now ready for the Q&A, we kindly ask all participants to limit her or himself with 1 or maximum 2 questions.

    2023 年,我們期待繼續專注於商業執行,擴大我們的產品線,並大力投資擴大當前和未來產品的產能。現在我們已經準備好進行問答,我們懇請所有參與者限制她或他自己提出 1 個或最多 2 個問題。

  • Operator, we're now ready to take the first question.

    接線員,我們現在準備好回答第一個問題。

  • Operator

    Operator

  • (Operator Instructions) We will now take our first question. One moment, please. And it comes from the line of Harry Sephton from Credit Suisse.

    (操作員說明)我們現在開始第一個問題。稍等一會兒。它來自瑞士信貸的 Harry Sephton 系列。

  • Harry Thomas d'Alton Sephton - Research Analyst

    Harry Thomas d'Alton Sephton - Research Analyst

  • It'll just be the 1 on pricing, please. So our latest pricing data suggests that you've only taken a low single-digit price increase in January across your U.S. portfolio, despite the larger headroom for price increases this year with high CPI. Could you look to increase prices a second time later in the year given the headroom for price increases?

    拜託,這只是定價的第一個。因此,我們最新的定價數據表明,儘管今年 CPI 較高,價格上漲空間較大,但 1 月份您的美國投資組合價格僅出現了較低的個位數漲幅。考慮到價格上漲的空間,您能否在今年晚些時候第二次提高價格?

  • And then just on your international operations as well. There are a number of drug pricing reforms being proposed across European markets. Do you anticipate that these changes could be material near-term headwinds to your growth in international operations?

    然後還有您的國際業務。歐洲市場正在提議進行多項藥品定價改革。您預計這些變化是否會在短期內對您的國際業務增長構成重大阻力?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Harry. So Doug, a perspective on how we look at pricing in the U.S. first.

    謝謝你,哈利。所以道格,首先是關於我們如何看待美國定價的觀點。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Yes. Thanks, Harry, for the question. We had a commitment back in 2016 around price and we've held to that commitment. And I don't want to give any forward-looking statements on price moving forward.

    是的。哈利,謝謝你提出這個問題。早在 2016 年,我們就價格做出了承諾,並且我們一直堅持這一承諾。而且我不想就未來的價格發表任何前瞻性陳述。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you. So on Europe, we don't anticipate any single event to be material. We have, over the years, seen various countries operating with different reforms, sometimes in the form of something that looks more like a tax. So we are used to operating in this environment, and you should expect that for now, our guidance incorporates what we anticipate in this. Thank you, Harry.

    謝謝。因此,在歐洲,我們預計不會有任何單一事件具有重大意義。多年來,我們看到不同的國家實施了不同的改革,有時採取的形式更像是一種稅收。因此,我們習慣於在這種環境中運營,您應該期待,目前我們的指南包含了我們在此方面的預期。謝謝你,哈利。

  • Operator

    Operator

  • We will now take the next question. And it comes from the line of Peter Verdult from Citi.

    我們現在開始下一個問題。它來自花旗的 Peter Verdult 系列。

  • Peter Verdult - MD

    Peter Verdult - MD

  • Peter Verdult, Citi. Two questions. Doug, you can be the first, just in light of these U.S. GLP-1 trends we're seeing, the intense publicity and media coverage, can you characterize how, if at all, recent payer discussions are evolving? Are you sensing any efforts to step up and restrict access more aggressively? And can you provide an update on the 30 million commercial opt-in number that you provided in Q3?

    Peter Verdult,花旗銀行。兩個問題。道格,你可以是第一個,鑑於我們看到的這些美國 GLP-1 趨勢,強烈的宣傳和媒體報導,你能描述一下最近的付款人討論是如何演變的嗎?您是否感覺到有任何努力加強和更積極地限制訪問?您能否提供您在第 3 季度提供的 3000 萬商業選擇加入數字的最新信息?

  • And then to Lars and Karsten, just if I could try my luck and push you to better understand what is possible and what is not with respect to Wegovy capacities that you have in place for 2023. If I look at the Q1 trends, we're fast approaching 40,000 weekly script rate, which is implying annualized sales around DKK 2 billion. I know you've talked about pent-up demand, but you and Lilly are also going to start promoting proactively to develop the market further. So just with that in mind, do you have the theoretical capacity in place to support Wegovy being a DKK 3 billion to DKK 4 billion drug in 2023? I'm not asking for guidance, but I want to get a handle on what's possible and what is pure fancy with respect to the obesity market potential this year?

    然後是 Lars 和 Karsten,如果我能試試運氣並促使你們更好地了解你們在 2023 年擁有的 Wegovy 能力方面什麼是可能的,什麼是不可能的。如果我看一下第一季度的趨勢,我們'我們正在快速接近每週 40,000 個腳本率,這意味著年銷售額約為 20 億丹麥克朗。我知道你已經談到了被壓抑的需求,但你和禮來也將開始積極推廣以進一步開發市場。因此,考慮到這一點,您是否具備支持 Wegovy 在 2023 年成為 30 億至 40 億丹麥克朗藥物的理論能力?我不是在尋求指導,但我想了解關於今年肥胖市場潛力的可能性和純粹幻想的東西?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Pete. So Doug, first, on U.S. GLP-1 trends, payer discussions and the patient access we have.

    謝謝你,皮特。所以道格,首先,關於美國 GLP-1 趨勢、付款人討論和我們擁有的患者訪問。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Yes. Thanks, Pete, for the question. And I would say that certainly, first thing to recognize is that the volume of prescriptions in the GLP-1 category is still only about 10%. So there's a lot of runway there. Secondly, what I would say is that the payers do take notice the categories that are growing. This one is certainly growing at double digit, but they also recognize the need for this product. And again, it's only 10% of the prescription volume. Did I miss something within here?

    是的。謝謝皮特提出這個問題。我肯定會說,首先要認識到的是 GLP-1 類別的處方量仍然只有 10% 左右。所以那裡有很多跑道。其次,我要說的是,付款人確實注意到了正在增長的類別。這當然是兩位數的增長,但他們也認識到對這種產品的需求。而且,它只是處方量的 10%。我在這裡錯過了什麼嗎?

  • Peter Verdult - MD

    Peter Verdult - MD

  • 30 million.

    三千萬。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Yes, Pete, I'm sorry. Importantly, we guided on -- in Q3 of 30 million. We're now at approximately 40 million lives. So it's overall 80% access, and that equates to the effective access or number of lives is approximately 40 million. And that's comprised of commercial, Medicaid and some federal business.

    是的,皮特,對不起。重要的是,我們在第三季度指導了 3000 萬。我們現在有大約 4000 萬人的生命。因此,總體訪問率為 80%,這相當於有效訪問或生命數量約為 4000 萬。這包括商業、醫療補助和一些聯邦業務。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Doug. And Karsten, on Wegovy capacity versus what we see in the market now. I know you're not going to tell the whole story. What can you say?

    謝謝你,道格。還有 Karsten,關於 Wegovy 容量與我們現在在市場上看到的容量。我知道你不會說出整個故事。你能說什麼?

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Yes. So it's, of course, a key question that we spend a lot of time on also internally to ensure that we're not disappointing our customers when we launch products in different markets. And my starting point to answering the question is, the guidance I just covered before. So it's 13% to 19% top line growth guidance, which in itself is very competitive industry-wise, is, of course, very attractive and a large chunk of that growth comes from Wegovy. So we will not be able to get to this level of guidance without a significant step-up in Wegovy.

    是的。因此,這當然是我們在內部花費大量時間的一個關鍵問題,以確保我們在不同市場推出產品時不會讓客戶失望。我回答這個問題的出發點是我之前提到的指導。因此,它是 13% 到 19% 的頂線增長指導,這本身在行業方面非常有競爭力,當然非常有吸引力,而且很大一部分增長來自 Wegovy。因此,如果 Wegovy 沒有顯著提升,我們將無法達到這一水平的指導。

  • And as I'm sure you can appreciate, then it's important for us to say that we can supply to our guidance, to both the top end and the low end of the guidance. So that's what we commit to in terms of our investor communication.

    而且我相信你會理解,那麼重要的是我們要說我們可以為我們的指導提供指導,包括指導的高端和低端。這就是我們在投資者溝通方面的承諾。

  • Then in terms of additional scenarios, then what I would say is that the -- that 19% is not a magic ceiling. In terms of our guidance, it's basically a function of products and geographies and timing. And then yes, we continue to scale our manufacturing capacity of Wegovy. As you know, we have 1 line in-house. We have 1 CMO up and running full speed and we have 1 line on track to be online in first half of this year. And then another line on track to be -- get online second half this year. So we have significant step-up in Wegovy production capacity.

    然後就其他情況而言,我要說的是 - 19% 不是一個神奇的上限。就我們的指導而言,它基本上是產品、地理位置和時間的函數。然後是的,我們繼續擴大 Wegovy 的製造能力。如您所知,我們內部有 1 條生產線。我們有 1 個 CMO 正在全速運行,我們有 1 條生產線有望在今年上半年上線。然後另一條線路將在今年下半年上線。因此,我們顯著提高了 Wegovy 的生產能力。

  • And then I'd say, just as a final note, of course, we have -- we do not have unlimited capacity. And so trending on a vertical TRx uptake is impossible. And that's why we've been out saying be careful with the first data points because they are impacted by the pent-up demand that Doug was talking to.

    然後我想說,作為最後一點,當然,我們有——我們沒有無限的容量。因此,垂直 TRx 攝取的趨勢是不可能的。這就是為什麼我們一直在說要小心第一個數據點,因為它們受到道格所說的被壓抑的需求的影響。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Karsten. So to summarize, clearly, a significant addressable market, from an access point of view and also capacity coming in, so we can go after that opportunity. So very encouraging, indeed. Thank you, Pete.

    謝謝你,卡斯滕。因此,從訪問的角度和容量的角度來看,明確地總結了一個重要的潛在市場,因此我們可以抓住這個機會。確實非常鼓舞人心。謝謝你,皮特。

  • Operator

    Operator

  • We will now take the next question. And it comes from the line of Michael Nedelcovych from Cowen.

    我們現在開始下一個問題。它來自 Cowen 的 Michael Nedelcovych 系列。

  • Michael Thomas Nedelcovych - Research Associate

    Michael Thomas Nedelcovych - Research Associate

  • I have 2. The first is on the SELECT trial. When taking interim looks at SELECT, does Novo consider whether or not a futility analysis has been prespecified and presumably passed the material information to be shared with the market? That's the first question.

    我有 2 個。第一個是在 SELECT 試用版上。在對 SELECT 進行臨時審查時,Novo 是否考慮了是否預先指定了無效性分析並可能通過了與市場共享的重要信息?這是第一個問題。

  • And then the second question is on the oral semaglutide readout. So when we see Phase III obesity data for oral semaglutide, some of our consultants are expecting meaningfully diminished weight loss relative to injectables. If that ends up being the case, what percent weight loss would still support commercial success?

    然後第二個問題是關於口服 semaglutide 的讀數。因此,當我們看到口服 semaglutide 的 III 期肥胖數據時,我們的一些顧問預計與註射劑相比,體重減輕會顯著減少。如果最終是這樣,減重多少百分比仍會支持商業成功?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Michael. I think Martin those are, both to you.

    謝謝你,邁克爾。我認為 Martin 對你來說都是。

  • Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

    Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

  • Yes, absolutely. So with regard to SELECT, as we already discussed, we had 1 look before the expected final outcome of the trial. That was done by a DMC. So we are not privy to the data. The DMC is looking at the totality of the data, and there was a prespecification for -- when they could recommend stop use of the -- very convincing superiority for semaglutide, i.e., more than 20% difference between semaglutide and placebo.

    是的,一點沒錯。因此,關於 SELECT,正如我們已經討論過的,我們在試驗的預期最終結果之前進行了 1 次觀察。這是由 DMC 完成的。所以我們不知道數據。 DMC 正在查看全部數據,並且有一個預先說明——他們何時可以建議停止使用 semaglutide——非常令人信服的優越性,即 semaglutide 和安慰劑之間的差異超過 20%。

  • They recommended us to continue the trial, which makes us believe that we are probably still in the realm of the 17% that we have sample sized for. But they look at everything and they can recommend to stop the trial should they feel to do so.

    他們建議我們繼續試驗,這使我們相信我們可能仍處於樣本量所針對的 17% 的範圍內。但他們會查看所有內容,如果他們覺得這樣做,他們可以建議停止試驗。

  • With regards to oral semaglutide, both in diabetes and obesity, the trials are assigned and the doses are picked so there we expect to get exposure similar to that of subcutaneous semaglutide, both Ozempic 2.0 milligram, and Rybelsus 2.4 milligram. And we would, therefore, aim to have full efficacy and full safety profile comparable to those 2 formulations.

    關於口服 semaglutide,無論是在糖尿病還是肥胖症中,都分配了試驗並選擇了劑量,因此我們期望獲得與皮下 semaglutide 相似的暴露,Ozempic 2.0 毫克和 Rybelsus 2.4 毫克。因此,我們的目標是具有與這兩種配方相當的全部功效和全部安全性。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • So very attractive product profiles from what we can tell from a commercial opportunity perspective. Thank you, Martin, and thank you, Michael.

    從商業機會的角度來看,我們可以看出非常有吸引力的產品概況。謝謝 Martin,也謝謝 Michael。

  • Operator

    Operator

  • We will now take the next question. It comes from the line of Sachin Jain from Bank of America.

    我們現在開始下一個問題。它來自美國銀行的 Sachin Jain 系列。

  • Sachin Jain - MD & Research Analyst

    Sachin Jain - MD & Research Analyst

  • Sachin Jain, Bank of America. Just 2 very simple questions, trying to get a bit more color on what you can guide. So again, I'll try my luck. So firstly, on obesity, you've noted inherent uncertainty. I think there's been commentary on pent-up demand and careful with those data points. I'm just trying to get a sense of how much of bolus you think this will go over the first couple of weeks and best expectations for a run rate once that bolus comes off?

    美國銀行的 Sachin Jain。只有 2 個非常簡單的問題,試圖在您可以指導的內容上獲得更多色彩。所以,我再試試運氣。所以首先,關於肥胖,你已經註意到了內在的不確定性。我認為已經對被壓抑的需求進行了評論,並對這些數據點保持謹慎。我只是想了解您認為這將在前幾週進行多少推注,以及一旦推注完成後對運行率的最佳預期?

  • And then secondly, I know Karsten, we've discussed this a lot before, but GLP-1 growth rate is the biggest delta to guide. Just from your perspective, are you expecting a trend shift through full year '23 from the existing 40% to 50% growth because I don't think a continuation of existing trends as assumed even in the top end of guide.

    其次,我認識 Karsten,我們之前已經討論過很多,但 GLP-1 增長率是最大的指導增量。僅從您的角度來看,您是否期望整個 23 年的趨勢從現有的 40% 增長到 50%,因為我認為即使在指南的頂端也不會延續現有趨勢。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Sachin. If I try to address the first question on Wegovy pent-up demand and sizing of that, and then Karsten, you can get to the GLP-1. So we know for a fact that patients have been lined up. We have had some 60-plus patients on notice for when products would be available. That's a quite unusual situation to have. So we know for a fact that there is pent-up demand. It's really difficult for us to size it, to be honest. We are obviously encouraged by the trend line we see. But we also do believe that there will be a normalization of that as we have gone through that bolus. But it's really very difficult for us to give any meaningful sizing of it.

    謝謝你,薩欽。如果我嘗試解決關於 Wegovy 被壓抑的需求和規模的第一個問題,然後是 Karsten,你可以進入 GLP-1。所以我們知道病人已經排好隊了。我們已經通知了大約 60 多名患者產品何時可用。這是一個非常不尋常的情況。所以我們知道存在被壓抑的需求這一事實。老實說,我們真的很難確定它的大小。我們顯然對我們看到的趨勢線感到鼓舞。但我們也確實相信,隨著我們經歷了那次推注,這種情況將會正常化。但我們真的很難對其進行任何有意義的調整。

  • We'll be looking at the first, say, a couple of months, say, Q1 to really understand the -- how that looks. So -- but the first data points are really exciting. So we feel we're in a really, really good place. Karsten, on growth rates, I recall we've been saying in prior years that we thought the growth rate was going down. It didn't happen. So any crystal ball now?

    我們將著眼於第一個,比如說,幾個月,比如說,第一季度,以真正了解 - 它看起來如何。所以 - 但第一個數據點真的很令人興奮。所以我們覺得我們處在一個非常非常好的地方。 Karsten,關於增長率,我記得我們在前幾年一直在說我們認為增長率正在下降。它沒有發生。那麼現在有水晶球嗎?

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Yes. Thanks for reminding me on that one. So I'd say for -- first of all, that's 1 of the reasons why we have a forward-looking statement in our announcements. That is when we start to comment on future market growth rates. And I'd say secondly, that's also 1 of the reasons why we are rolling with an unusually broad guidance range this time around.

    是的。謝謝你提醒我那個。所以我要說 - 首先,這是我們在公告中有前瞻性聲明的原因之一。那是我們開始評論未來市場增長率的時候。其次,我要說的是,這也是我們這次推出異常廣泛的指導範圍的原因之一。

  • When we look at the market growth, I can start out with the U.S. MAT-wise for -- based on the latest monthly data points or the latest data points overall. We are around 40%, and that would be the same ex-U.S. also. So a global volume market growth MAT-wise, around 40% being the latest data point. If we take shorter data points in the U.S., we're closer to the 50% mark as a data point.

    當我們看市場增長時,我可以從美國 MAT 開始——基於最新的月度數據點或最新的整體數據點。我們大約是 40%,這將是相同的前美國。還。因此,全球銷量市場增長 MAT-wise,大約 40% 是最新的數據點。如果我們在美國採用更短的數據點,我們更接近 50% 的數據點。

  • In terms of what that implies going forward, that's of course, a function of our activities and competitor activities, as well as supply capacity for the players in the markets. So I'd say, we have built our guidance based on continued strong market growth. Of course, I cannot give you our assumptions but more than to say continued strong market growth and GLP-1 in diabetes being a key growth driver for Novo Nordisk also in '23.

    就這意味著向前發展而言,這當然是我們的活動和競爭對手活動的一個功能,以及市場參與者的供應能力。所以我想說,我們已經根據持續強勁的市場增長建立了我們的指導。當然,我不能給你我們的假設,但不僅僅是說持續強勁的市場增長和糖尿病中的 GLP-1 也是諾和諾德在 23 年的主要增長動力。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Maybe just adding to that. When you have a category where you have efficacious products competing against each other, it typically leads to market growth more than share gain and that's what we see in type 2 diabetes. And I think that's also what we would expect to see in the obesity category that efficacious products drives market growth more than the share play. Thank you, Karsten. Thank you, Sachin.

    也許只是增加了這一點。當您擁有一個有效產品相互競爭的類別時,它通常會導致市場增長超過份額增長,這就是我們在 2 型糖尿病中看到的情況。我認為這也是我們期望在肥胖類別中看到的,有效的產品比市場份額更能推動市場增長。謝謝你,卡斯滕。謝謝你,薩欽。

  • Operator

    Operator

  • We will now take the next question. It comes from the line of Richard Parkes from BNP Paribas.

    我們現在開始下一個問題。它來自法國巴黎銀行的理查德帕克斯系列。

  • Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team

    Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team

  • Just got a couple. Firstly, on the CapEx expansion plans. And just wondering whether you can give us any indication of what that increased capacity could allow you to meet in terms of market expansion kind of by the end of the decade, at least some kind of ballpark range in terms of kind of what market -- GLP-1 market expansion, that would allow you to meet supply for would be really helpful.

    剛入手一對。首先,關於資本支出擴張計劃。只是想知道你是否可以告訴我們,到本世紀末,增加的產能可以讓你在市場擴張方面達到什麼樣的目標,至少在某種市場範圍內—— GLP-1 市場擴張,這將使您能夠滿足供應,這將非常有幫助。

  • And then secondly, on the ONWARDS 1 and 2 trials of insulin icodec, I mean, playing devil's advocate looks incrementally worse than previously. I think with the HBA1c advantage no longer significant or significantly worse in both trials showing worse hyperglycemia profile. So I'm just wondering how this impacts your expectations from that product over both approvability and commercial potential.

    其次,在胰島素 icodec 的 ONWARDS 1 和 2 試驗中,我的意思是,唱反調看起來比以前更糟糕了。我認為 HBA1c 的優勢在兩項顯示更差的高血糖狀況的試驗中不再顯著或明顯更差。所以我只是想知道這會如何影響您對該產品的認可度和商業潛力的期望。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Richard, so let me just try to give a perspective on CapEx. And then Martin, you can get to the ONWARDS trials. So for us, this is to create, obviously, ability to supply in a market that we believe will have a very, very attractive growth, creates strategic flexibility. And I think in the GLP-1 space, you will have the potential of having one of the biggest, say, drop in categories ever seen. So really being able to build that capacity and serve the markets, I believe, creates a competitive advantage that is very, very attractive.

    理查德,所以讓我試著談談資本支出的觀點。然後 Martin,你可以開始 ONWARDS 試驗。因此,對我們來說,這顯然是為了在我們認為將具有非常非常有吸引力的增長的市場中創造供應能力,創造戰略靈活性。而且我認為在 GLP-1 領域,你將有可能擁有有史以來最大的類別下降之一。因此,我相信,真正能夠建立這種能力並為市場服務,會創造出非常非常有吸引力的競爭優勢。

  • So we also have a pipeline of products coming that will be using the same type of capacity. So both from an API and fill finish perspective, we have a lot of optionality in the footprint we have. And being able to build this and drive efficiencies is something that's required to play longer term in this category. So you should take it as a sign of confidence and trust in the existing business we have and the pipeline we have coming. Martin, on ONWARDS and the latest there and what is happening for the potential?

    因此,我們還有一系列產品將使用相同類型的容量。因此,無論是從 API 還是填充完成的角度來看,我們在我們擁有的足跡上都有很多可選性。能夠構建這一點並提高效率是在這一類別中長期發揮作用所必需的。因此,您應該將其視為對我們現有業務和即將到來的管道的信心和信任的標誌。 Martin,關於 ONWARDS 和那裡的最新消息以及潛在的情況是什麼?

  • Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

    Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

  • Yes, absolutely. So first of all, it's important to recall that both ONWARDS 1 and ONWARDS 6 were originally 52- and 26-week studies. This was the regulatory intent. And in the 52-week period of the ONWARDS 1 study, as you know, we showed a superior A1C reduction with a good and flat and stable, sorry, hypoglycemia profile.

    是的,一點沒錯。所以首先,重要的是要記住 ONWARDS 1 和 ONWARDS 6 最初都是 52 周和 26 週的研究。這是監管意圖。在 ONWARDS 1 研究的 52 週期間,如您所知,我們顯示出優異的 A1C 降低以及良好、平坦和穩定的低血糖情況。

  • We then for regulatory reasons, have to do extensions of those 2 studies in both type 2 and in type 1 diabetes, basically because we need to show safety exposure. So this focus of the extension is safety assessment and establishing the long-term safety profile of insulin icodec in both type 1 and type 2 diabetes.

    然後,出於監管原因,我們必須對 2 型和 1 型糖尿病的這兩項研究進行擴展,主要是因為我們需要顯示安全暴露。因此,擴展的重點是安全性評估,並建立胰島素 icodec 在 1 型和 2 型糖尿病中的長期安全性概況。

  • If I stay with ONWARDS 1, over the additional 26 weeks, we actually saw a completely flat A1C curve, so a maintained glycemic control over time. We lost the statistical significance. But again, in an open label extension, you also lose a little bit of rigor and power, and we sort of have to expect that, but it certainly confirms the efficacy profile of insulin icodec.

    如果我繼續使用 ONWARDS 1,在接下來的 26 週內,我們實際上看到了完全平坦的 A1C 曲線,因此隨著時間的推移保持了血糖控制。我們失去了統計意義。但同樣,在開放標籤擴展中,你也會失去一點嚴謹性和力量,我們有點不得不期待這一點,但它肯定證實了胰島素 icodec 的功效概況。

  • With regards to hypoglycemia, first of all, it's important to recall already at 52 weeks, we saw very, very low hypoglycemia rates. There was a numerical difference between the 2 insulins, and that difference actually remained completely stable throughout the trial. So when we then see this is statistically significant, it's a function of more events rather than all of a sudden seeing a difference between the 2 treatment arms. And it's also important if we put that into a clinical context, to recall with the rates that we have seen, a patient on insulin icodec in this setting would have to wait 2 to 3 years to experience an event of not severe hypoglycemia.

    關於低血糖,首先,重要的是要記得在 52 週時,我們發現低血糖發生率非常非常低。兩種胰島素之間存在數值差異,並且該差異在整個試驗過程中實際上保持完全穩定。因此,當我們看到這具有統計學意義時,它是更多事件的函數,而不是突然看到兩個治療組之間的差異。同樣重要的是,如果我們將其置於臨床環境中,回顧我們所看到的發生率,在這種情況下使用 icodec 胰島素的患者將不得不等待 2 至 3 年才能經歷不嚴重的低血糖事件。

  • And in that context, I also want to call out that the risk of having severe hypoglycemia with insulin icodec in ONWARDS 1 was almost a factor of 10 lower than with insulin degludec. So again, confirming the safety profile of icodec in this setting. So we remain very, very confident from a clinical perspective that icodec is the perfect starter insulin for type 2 diabetes. And obviously, we're looking at ONWARD 6, we have to acknowledge that we have some work to do with type 1 diabetes, and Camilla can maybe talk to the commercial potential of both obviously type 2, type 1 diabetes.

    在這種情況下,我還想指出,在 ONWARDS 1 中使用 icodec 胰島素發生嚴重低血糖的風險幾乎比使用 degludec 胰島素低 10 倍。因此,再次確認 icodec 在此設置中的安全配置文件。因此,從臨床角度來看,我們仍然非常非常有信心 icodec 是治療 2 型糖尿病的完美起始胰島素。顯然,我們正在研究 ONWARD 6,我們必須承認我們有一些與 1 型糖尿病有關的工作,卡米拉也許可以談論明顯的 2 型和 1 型糖尿病的商業潛力。

  • Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

    Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

  • Yes. Thanks a lot, Martin. So based on the totality of the data that you just went through and from the total ONWARDS program, we are very confident in the efficacy and the safety profile of once weekly icodec and also the potential to become standard of care and insulin of choice for people with type 2 diabetes. And once-weekly insulin, of course, represents a whole new way of managing insulin that gives a lot of benefits to people, as just described, but also on the convenience part, it by the way, also has a very positive environmental profile.

    是的。非常感謝,馬丁。因此,根據您剛剛查看的全部數據和整個 ONWARDS 計劃,我們對每週一次 icodec 的療效和安全性以及成為人們選擇的標準護理和胰島素的潛力充滿信心患有 2 型糖尿病。當然,每週一次的胰島素代表了一種全新的管理胰島素的方式,正如剛才所描述的那樣,它給人們帶來了很多好處,而且在便利性方面,順便說一句,它也具有非常積極的環境影響。

  • And to your question about type 1 diabetes, we would estimate that, that is to the tune of potentially 7% of the total potential. So that doesn't change our overall profile of icodec potential.

    對於你關於 1 型糖尿病的問題,我們估計,這可能佔總潛力的 7%。因此,這不會改變我們對 icodec 潛力的整體概況。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Camilla. Thank you, Martin. It's a clear sign of our commitment to raising the innovation height also in a classical area. We embarked upon on a journey at Novo Nordisk. We're still investing in insulin and I think we can drive tremendous value for patients and physicians here, still 100 years in. Thank you, Richard.

    謝謝你,卡米拉。謝謝你,馬丁。這清楚地表明了我們致力於在經典領域提高創新高度的承諾。我們在諾和諾德開始了一段旅程。我們仍在投資胰島素,我認為我們可以為這裡的患者和醫生帶來巨大的價值,仍然是 100 年。謝謝你,理查德。

  • Operator

    Operator

  • We will now take the next question. It comes from the line of Richard Vosser from JPMorgan.

    我們現在開始下一個問題。它來自摩根大通的 Richard Vosser 系列。

  • Richard Vosser - Senior Analyst

    Richard Vosser - Senior Analyst

  • First question, just thinking on Ozempic trends and how you see those going forward. I think Q3, you were saying 40% of patients were naive to diabetes treatment of the new patients going on Ozempic. How are you seeing the Wegovy relaunch impact that? And how do you see sort of that Ozempic situation developing throughout this year with Wegovy back into to full supply? Do you see that slowing down significantly because of Wegovy?

    第一個問題,只是考慮 Ozempic 趨勢以及您如何看待這些趨勢。我認為 Q3,你是說 40% 的患者對接受 Ozempic 的新患者的糖尿病治療是天真的。您如何看待重新啟動 Wegovy 的影響?您如何看待今年全年隨著 Wegovy 恢復全面供應而出現的那種 Ozempic 情況?您是否看到由於 Wegovy 而顯著放緩?

  • And then second question. Just going back to the reimbursement and payers. Obviously, very good getting 40 million patients. How are the payers treating the patients maybe in the second, maybe third year of treatment, if patients get that long? If they reach levels of normal BMI or lose significant amounts of weight, do payers then say, well, that's brilliant, you're back to normal and they come off the drug? Or how are they treating that in your reimbursement discussions?

    然後是第二個問題。只是回到報銷和付款人。顯然,獲得 4000 萬患者非常好。如果患者得到那麼長的治療時間,付款人如何在治療的第二年或第三年治療患者?如果他們達到正常 BMI 水平或顯著減輕體重,付款人會說,好吧,太棒了,你恢復正常了,他們就停藥了?或者他們在您的報銷討論中如何處理?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Richard. First, Camilla, on the Ozempic trends after Wegovy is in the market, then Doug, you can talk a bit to payers with a U.S. perspective.

    謝謝你,理查德。首先,Camilla,關於 Wegovy 上市後的 Ozempic 趨勢,然後是 Doug,你可以從美國的角度與付款人談談。

  • Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

    Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

  • Yes. So on Ozempic, we see a continued increase. We see -- we are back to TRx and NBRx leadership. When it comes to how much of the Wegovy sourcing that is from diabetes, then we can say that the uplift in the Wegovy trends in the U.S. is basically from primarily the 0.25 milligram, the starter dose. And that basically means that these are patients that are new to GLP-1 treatment. Of course, looking forward, that means that we expect that there is a potential for both of these 2 classes to coexist and to continue increasing as we see both unexploited potential for GLP-1 treatment in diabetes as well as in obesity.

    是的。因此,在 Ozempic 上,我們看到了持續增長。我們看到——我們又回到了 TRx 和 NBRx 的領導地位。當談到有多少 Wegovy 採購來自糖尿病時,我們可以說美國 Wegovy 趨勢的提升基本上主要來自起始劑量 0.25 毫克。這基本上意味著這些是 GLP-1 治療的新患者。當然,展望未來,這意味著我們預計這兩個類別有可能共存並繼續增加,因為我們看到 GLP-1 治療糖尿病和肥胖症的潛力尚未開發。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Camilla. Doug, on the payer's perspective on multiple years of treatment.

    謝謝你,卡米拉。 Doug,關於付款人對多年治療的看法。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Richard, thank you. I think it's important to note that we're pleased with the level of access that we have today. Overall, 80% access is something that we're proud of, and the team has done a nice job. The effective access we've been hard at work at. As you know, this requires opt-ins.

    理查德,謝謝你。我認為重要的是要注意我們對今天的訪問級別感到滿意。總的來說,80% 的訪問率是我們引以為豪的事情,團隊做得很好。我們一直在努力工作的有效訪問。如您所知,這需要選擇加入。

  • But again, we're pleased with the overall 40 million lives that can have access. And how the payers are treating this. There's no stopping rules in place today. And I think the payers recognize that this is a chronic treatment, and that's important for not only stakeholders, payers, but all the work that we're doing is to realize this as a serious chronic disease, and it's a chronic disease that needs long-term treatment.

    但同樣,我們對總共 4000 萬人的生命可以獲得訪問感到滿意。以及付款人如何對待這個。今天沒有停止規則。我認為付款人認識到這是一種慢性治療,這不僅對利益相關者、付款人很重要,而且我們正在做的所有工作都是為了認識到這是一種嚴重的慢性病,這是一種需要長期治療的慢性病- 長期治療。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Camilla. Thank you, Doug. Thank you, Richard.

    謝謝你,卡米拉。謝謝你,道格。謝謝你,理查德。

  • Operator

    Operator

  • We will now take the next question. It comes from the line of Michael Leuchten from UBS.

    我們現在開始下一個問題。它來自 UBS 的 Michael Leuchten 系列。

  • Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research

    Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research

  • 2 questions, please. Michael Leuchten from UBS. One, if I look at the value of the volume for Ozempic and Rybelsus in the U.S., there seem to be some trend changes in Q4, maybe Ozempic also in Q3. Is that a fair reflection of the competitive rebating environment? Or should we not overinterpret those trends as we think about the value to volume, looking into 2023?

    2個問題,請。來自瑞銀的 Michael Leuchten。第一,如果我看一下美國 Ozempic 和 Rybelsus 的交易量值,第四季度似乎有一些趨勢變化,也許 Ozempic 也在第三季度。這是競爭性回扣環境的公平反映嗎?還是我們在考慮 2023 年的銷量價值時不應過度解讀這些趨勢?

  • And then a question for Martin. SELECT isn't really something you talk about actively anymore. It only really comes up in Q&A. Is that because in your mind, the relevance has taken a step back given it didn't stop at the interim? And we're maybe on track for the 17% risk reduction, which may or may not mean as meaningful as maybe a 25% would have been? Or is there another reason why you don't mention it as much more as you have in the past?

    然後是馬丁的問題。 SELECT 不再是您主動談論的話題。它只會真正出現在問答中。那是因為在你看來,相關性已經後退了一步,因為它並沒有在過渡期間停止?我們可能正朝著降低 17% 的風險邁進,這可能意味著也可能不會像 25% 那樣有意義?還是有其他原因導致您沒有像過去那樣經常提及它?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Michael. So first, Karsten, on value versus volume dynamics for GLP-1 class.

    謝謝你,邁克爾。首先,Karsten,關於 GLP-1 類的價值與體積動態。

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Yes. So Michael, first of all, to your Q4 questions versus '22 overall, then there are no changes vis-a-vis '22. So as you know, normally, then for '24, then we -- give the lag of scripts, then there will be true-ups normally in Q4 that can impact the value to volume equation. So I think the more appropriate way to look at it is for the full year. And then I'd say on top of that, given the supply situation on Ozempic, there might be also some noise in that calculation from changes in inventory levels on Ozempic specifically. From there, moving into 2023, while not guiding for value and volume for '23, then I would say the dynamics remain the same between '22 and '23.

    是的。所以邁克爾,首先,關於你的 Q4 問題與 22 年的整體情況,然後相對於 22 年沒有變化。因此,正如您所知,通常情況下,然後是 24 年,然後我們 - 給出腳本的滯後,然後通常會在第四季度進行調整,這可能會影響體積方程式的價值。所以我認為更合適的看待方式是全年。然後我要說的是,考慮到 Ozempic 的供應情況,該計算中可能還存在一些噪音,特別是 Ozempic 庫存水平的變化。從那裡開始,進入 2023 年,雖然沒有指導 23 年的價值和數量,但我會說 22 年和 23 年之間的動態保持不變。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Karsten. And Martin, on SELECT, why are you not talking about SELECT?

    謝謝你,卡斯滕。 Martin,關於 SELECT,你為什麼不談論 SELECT?

  • Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

    Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

  • So first of all, we are still very excited and very confident about SELECT. Issue is obviously that we have no results to share. We have no data to share. And therefore, the only thing I can call out, which hopefully you also saw in my part of the presentation is that we are looking very much forward to the data coming out around mid-2023. And that will be incredibly exciting. So we still think SELECT is very important and very exciting.

    所以首先,我們對SELECT還是很興奮也很有信心的。問題顯然是我們沒有結果可以分享。我們沒有數據可以分享。因此,我唯一可以說的是,希望您在我的演講中也看到了這一點,那就是我們非常期待 2023 年年中左右公佈的數據。這將是非常令人興奮的。所以我們還是覺得SELECT很重要,也很激動人心。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, that's the reason. Thank you, Michael.

    謝謝,是這個原因。謝謝你,邁克爾。

  • Operator

    Operator

  • We will now take the next question. It comes from the line of Keyur Parekh from Goldman Sachs.

    我們現在開始下一個問題。它來自高盛的 Keyur Parekh 系列。

  • Keyur Parekh - Equity Analyst

    Keyur Parekh - Equity Analyst

  • Two separate lines of questioning, please. The first one on CapEx. At the 2022 Capital Markets Day, your slides implied CapEx for 2025 to be between kind of DKK 10 billion and DKK 15 billion. What you're guiding today implies CapEx close to DKK 25 billion to DKK 30 billion in 2025. So just wondering, if you can give us a sense for kind of how much of that doubling of CapEx is attributable to your perception of higher demand for the existing products, so B2B kind of Rybelsus or GLP-1 diabetes products versus how much of this is with a view to ensuring supply for the non-diabetes, non-obesity product as that pipeline emerges over the course of the next kind of 2 to 3 years? So that's kind of question #1.

    請分兩行提問。第一個關於資本支出的。在 2022 年資本市場日,您的幻燈片暗示 2025 年的資本支出在 100 億至 150 億丹麥克朗之間。您今天的指導意味著 2025 年的資本支出將接近 250 億至 300 億丹麥克朗。所以只是想知道,您是否可以讓我們了解一下,資本支出翻倍有多少歸因於您對更高需求的看法現有產品,因此 B2B 類 Rybelsus 或 GLP-1 糖尿病產品與其中多少是為了確保非糖尿病、非肥胖產品的供應,因為該管道在下一種 2 的過程中出現到 3 年?所以這是第一個問題。

  • And then separately, kind of coming back to icodec. Camilla, would love your thoughts on how you think ONWARDS 1 and ONWARD 6, the extension data changes, if at all, the commercial positioning kind of for this molecule from your perspective. Does this make it a little bit more of an international product compared to a U.S. product given the convenience at play here? Or do you still think there exists room for you to have differential pricing for this molecule in the U.S. given the extension data?

    然後分別回到 icodec。卡米拉,很想知道你對 ONWARDS 1 和 ONWARD 6 的看法,擴展數據改變了,如果有的話,從你的角度來看,這種分子的商業定位。鑑於這裡的便利性,與美國產品相比,這是否使其更像是一種國際產品?還是您仍然認為,鑑於擴展數據,您在美國對這種分子有差別定價的空間?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Keyur. Two very clear questions. So first, Karsten, on CapEx versus what we said at Capital Markets Day and a perspective on existing products, new areas and then Camilla, you can talk to the icodec, say, commercial opportunity?

    謝謝你,基爾。兩個非常明確的問題。因此,首先,Karsten,關於資本支出與我們在資本市場日所說的內容以及對現有產品、新領域的看法,然後是 Camilla,您可以與 icodec 談談商業機會?

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Thank you, Lars. So CapEx, of course, quite a significant step up compared to our Capital Markets Day and again, that's why we have forward-looking statements. So the world has a tendency to change these days more than usual. I would say this step-up in CapEx to me, comes on a very positive background. I can, unfortunately, not to kind of separate how much is what because we have both (inaudible) platform. So it's a little bit trying to separate hot and cold water, unfortunately, Keyur.

    謝謝你,拉爾斯。因此,與我們的資本市場日相比,資本支出當然有了很大的進步,這也是我們有前瞻性陳述的原因。因此,當今世界比以往更傾向於發生變化。我想對我說資本支出的增加是在非常積極的背景下進行的。不幸的是,我不能區分多少是什麼,因為我們有兩個(聽不清)平台。所以它有點試圖將熱水和冷水分開,不幸的是,Keyur。

  • But I would say that the main drivers to it is, first of all, a stronger volume uptake than what we had built into our initial CapEx modeling clearly and the stronger volume uptake impacts both on the API side of our currently marketed products as well as the fill finish that we're scaling more so than the initial plans.

    但我要說的是,它的主要驅動因素首先是比我們在最初的資本支出模型中明確構建的更強大的體積吸收,並且更強大的體積吸收對我們當前銷售產品的 API 方面以及我們比最初計劃更大規模的填充完成。

  • And then as to the pipeline, I'd say there are 2 main drivers to step up. And you can say in a historic perspective, where we were like, call it, between 5% and 10% CapEx-to-sales and now we are more in the, call it, between 10% and 15% CapEx-to-sales ratio towards 25%. The delta is, that historically it was injectable peptide-based CapEx investments we're doing. And we continue to do that through the volume scaling I just spoke about. But on top of that, we are building to cater for the oral platform that just requires significantly higher amounts of API, whether it's for Rybelsus or semi obesity or some of the earlier oral compounds.

    然後關於管道,我想說有兩個主要驅動因素需要加強。你可以從歷史的角度說,我們之前的資本支出佔銷售額的比例在 5% 到 10% 之間,現在我們的資本支出佔銷售額的比例在 10% 到 15% 之間比例接近 25%。三角洲是,從歷史上看,我們正在進行的是可注射的基於肽的資本支出投資。我們將繼續通過我剛才談到的體積擴展來做到這一點。但最重要的是,我們正在構建以滿足只需要大量 API 的口服平台,無論是用於 Rybelsus 或半肥胖或一些早期的口服化合物。

  • As you know, we have all oral amycretin in Phase I, and we have an oral GLP-1/GIP also. So clearly, for the oral platform and then for the nonprotein peptide platforms, I would say we're looking at -- and what are we doing to cater for pipeline assets like Mim8 and ziltivekimab and our ATTR as well which is on an antibody platform. So that's where we're looking at also expanding our capacity on the monoclonal antibody side. So I hope that provides a little bit of color, but not fully able to separate the hot and the cold water.

    如您所知,我們在第一階段有所有口服阿米克汀,我們也有口服 GLP-1/GIP。很明顯,對於口服平台和非蛋白肽平台,我想說我們正在研究 - 我們正在做些什麼來滿足管道資產,如 Mim8 和 ziltivekimab 以及我們的抗體平台上的 ATTR .所以這就是我們正在考慮擴大我們在單克隆抗體方面的能力的地方。所以我希望能提供一點顏色,但不能完全把冷熱水分開。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Karsten. Exciting pipeline line leads to need for CapEx. So Camilla, how excited are you on icodec based on the recent data?

    謝謝你,卡斯滕。令人興奮的管道線導致需要資本支出。那麼 Camilla,根據最近的數據,您對 icodec 有多興奮?

  • Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

    Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

  • Thank you, Lars. And as we just discussed before, we remain very confident in the efficacy and safety profile of icodec that's given as a once-weekly insulin has the potential to become standard of care for people with type 2 diabetes.

    謝謝你,拉爾斯。正如我們之前討論的那樣,我們對 icodec 的療效和安全性非常有信心,因為每週一次的胰島素有可能成為 2 型糖尿病患者的標準治療。

  • And to your question, this has not changed our perspectives in terms of a global rollout of icodec. We remain equally confident in the U.S. and in the rest of the world for how this can help people with type 2 diabetes. And keep in mind that the potential of this is that the basal segment approximately includes 30 million patients with a value of around USD 8 billion. So that's a place where we today have a market share in the ballpark of 1/3, so there's ample potential to increase that.

    對於您的問題,這並沒有改變我們對全球推出 icodec 的看法。對於這如何幫助 2 型糖尿病患者,我們對美國和世界其他地區同樣充滿信心。請記住,這樣做的潛力在於基礎部分大約包括 3000 萬患者,價值約為 80 億美元。所以這是我們今天在 1/3 的市場份額的地方,所以有足夠的潛力來增加它。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Camilla. Thank you, Keyur.

    謝謝你,卡米拉。謝謝你,基爾。

  • Operator

    Operator

  • We will now take the next question. It comes from the line of Simon Baker from Redburn.

    我們現在開始下一個問題。它來自 Redburn 的 Simon Baker 系列。

  • Simon P. Baker - Head of Pharmaceutical Research

    Simon P. Baker - Head of Pharmaceutical Research

  • Two if I may, please. Firstly, and this relates to some earlier questions. In recent years, the increased spend in the U.S. on GLP-1 was offset by lower spending on insulin, which gave some easy headwind for the category to expand. I just wondering if you could give us an update on whether that is still the case?

    如果可以,請給我兩份。首先,這與之前的一些問題有關。近年來,美國在 GLP-1 上的支出增加被胰島素支出的減少所抵消,這給該類別的擴張帶來了一些阻力。我只是想知道您是否可以向我們提供最新情況,說明情況是否仍然如此?

  • And (inaudible) you talked about the impact of the Dicerna acquisition on 4Q R&D. I am just wondering if you can give us an idea how much of the additional R&D expense incurred was one-off and how much is continuing.

    而且(聽不清)你談到了收購 Dicerna 對第四季度研發的影響。我只是想知道你是否可以告訴我們有多少額外的研發費用是一次性的,有多少是持續的。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Simon. I don't know if you have those data, Doug from the top of your head.

    謝謝你,西蒙。我不知道你是否有這些數據,Doug 從你的頭頂上。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • What I would say is this, that insulin, as you saw, as we just reported, continues to be under pressure, pricing pressure, so payers still continue to take value there. And as I mentioned earlier, that's still only approximately 10% of the prescription volumes coming out of GLP-1. So we still think that there's opportunity there.

    我要說的是,正如你所看到的,正如我們剛剛報導的那樣,胰島素繼續承受壓力,定價壓力,因此付款人仍然繼續在那裡獲得價值。正如我之前提到的,這仍然只佔 GLP-1 處方量的大約 10%。所以我們仍然認為那裡有機會。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • You can add that to Q3, Q4. Price decline and soon to come, SGLT2 will also create some space to fund innovation. So yes, Karsten on Dicerna. Any one-off versus continued.

    您可以將其添加到 Q3、Q4。價格下降很快就會到來,SGLT2 也將創造一些空間來資助創新。所以是的,Dicerna 上的 Karsten。任何一次性與持續。

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Simon, as we've been communicating all along in terms of our overall strategic resource allocation, then we are highly focused on allocating additional resources towards R&D to expand and diversify our pipeline. And that you've seen throughout the year with a significant step-up in R&D spent ending at 29% for the full year.

    西蒙,由於我們一直在就整體戰略資源分配進行溝通,因此我們高度重視為研發分配額外資源,以擴大和多樣化我們的產品線。而且你已經看到全年研發支出顯著增加,全年達到 29%。

  • You're right that in the fourth quarter, we have an extraordinary step-up also when you do the quarterly trending. It's not due to Dicerna because we had Dicerna all along. So it's basically due to 2 factors: 1 being, a, I would say, minor impairment on intangible assets and another piece being costs related to the Forma Therapeutic transaction and restructuring.

    你是對的,在第四季度,當你做季度趨勢時,我們也有一個非凡的提升。這不是因為 Dicerna,因為我們一直都有 Dicerna。所以這基本上是由於兩個因素:一個是無形資產的輕微減值,另一個是與 Forma Therapeutic 交易和重組相關的成本。

  • And as you recall, then here at Novo, we are reporting clean numbers. So where other companies would have been -- some of the companies have been adjusting this into core earnings or adjusted earnings, then here you get, what you see is what you get. As to a specific number for Q4 in long terms between the 2 impairments and Forma, around DKK 0.5 billion.

    正如你所記得的那樣,在 Novo,我們報告的是乾淨的數字。因此,其他公司本來應該在的地方——一些公司一直在將其調整為核心收益或調整後收益,然後你就得到了,所見即所得。至於第 4 季度在 2 項減值和 Forma 之間的長期具體數字,約為 5 億丹麥克朗。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Simon. We have time for the final question.

    謝謝你,西蒙。我們有時間進行最後一個問題。

  • Operator

    Operator

  • We will now take the next question. It comes from the line of Mattias Häggblom from Handelsbanken.

    我們現在開始下一個問題。它來自 Handelsbanken 的 Mattias Häggblom 系列。

  • Mattias Häggblom - Research Analyst

    Mattias Häggblom - Research Analyst

  • Two questions, please. Firstly, with regards to the decision in January to double down and initiate the high dose semaglutide trial. I'm curious to understand what triggered the decision and why now almost 1.5 years after the Wegovy approval and why not earlier?

    請教兩個問題。首先,關於 1 月份加倍下注並啟動高劑量索馬魯肽試驗的決定。我很想知道是什麼觸發了這個決定,為什麼現在是在 Wegovy 批准後將近 1.5 年,為什麼不更早?

  • And then secondly, with top line data from SELECT data due mid-2023, what's a reasonable time frame from top line results and the data can help facilitate reimbursement outside the U.S., 1 year or is it rather 2 years, given the size and complexity of the study?

    其次,由於 SELECT 數據的頂線數據將於 2023 年年中到期,頂線結果的合理時間範圍是什麼?考慮到規模和復雜性,數據可以幫助促進美國以外的報銷,1 年還是 2 年的研究?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Mattias. So to you, Martin, high dose in obesity. Why now?

    謝謝你,馬蒂亞斯。所以對你來說,馬丁,高劑量肥胖。為什麼現在?

  • Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

    Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

  • So first of all, we see emerging data suggesting that it is possible to max out on GLP-1 biology. And it's very, very clear based on some of our reason studies that we could potentially increase exposure and thereby accruing more weight loss than what we see with the current doses. This obviously, we had to pursue and we had to investigate because there is an opportunity to, without compromising on safety, to accrue even more weight loss, specifically in obesity and potentially also improved glycemic control in diabetes. We aim to conduct these studies very, very fast, and that also means that they will be available to patients if the data supports it in a not-so distant future and still well within the relevant time period for semaglutide.

    所以首先,我們看到新出現的數據表明有可能最大限度地利用 GLP-1 生物學。根據我們的一些原因研究,非常非常清楚,我們可能會增加暴露量,從而比我們在當前劑量下看到的減重更多。顯然,我們必須追求並且必須進行調查,因為有機會在不影響安全性的情況下進一步減輕體重,特別是在肥胖方面,並且還可能改善糖尿病患者的血糖控制。我們的目標是非常、非常快地進行這些研究,這也意味著如果數據支持,它們將在不遠的將來提供給患者,並且仍然在 semaglutide 的相關時間段內。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Then there was a question on time line from SELECT data to reimbursement. So ballpark without going into too much detail.

    然後有一個關於從SELECT數據到報銷的時間線的問題。所以大概沒有進入太多細節。

  • Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

    Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

  • So some of you have heard about -- I was bragging about being able to obviously handle our clinical data in a reasonable way. I would not be looking at a 1- to 2-year time line. Obviously, we will close down the study. We will have the results around mid this year. We'll do a regulatory file, and then we'll have the regulatory interactions. And then it's in U.S. up to Doug and his team to discuss with payers and others on how that will impact the dynamics.

    所以你們中的一些人聽說過——我在吹噓能夠以合理的方式處理我們的臨床數據。我不會考慮 1 到 2 年的時間線。顯然,我們將結束這項研究。我們將在今年年中左右得出結果。我們將做一個監管文件,然後我們將進行監管互動。然後在美國由 Doug 和他的團隊與付款人和其他人討論這將如何影響動態。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Martin, thank you, Mattias, and thank you all for participating in our earnings call. Please reach out to our Investor Relations Officer if you have more questions and look forward to meet you and talk to you in the near future. Thank you very much. Bye-bye.

    謝謝 Martin,謝謝 Mattias,感謝大家參加我們的財報電話會議。如果您有更多問題,請聯繫我們的投資者關係官,期待在不久的將來與您見面並交談。非常感謝。再見。

  • Operator

    Operator

  • That does conclude our conference for today. Thank you for participating. You may all disconnect.

    我們今天的會議到此結束。感謝您的參與。你們都可以斷開連接。