諾和諾德 (NVO) 2023 Q4 法說會逐字稿

內容摘要

諾和諾德報告稱,在北美和國際業務成長的推動下,2023 年銷售額和營業利潤強勁成長。他們在減少碳排放、幫助未接受糖尿病和肥胖症治療的患者以及增加擔任高級領導職位的女性人數等方面取得了里程碑式的進展。

該公司還在其產品線方面取得了進展,並實現了肥胖和糖尿病領域的銷售目標。他們報告了 IcoSema 在 2 型糖尿病患者中進行的 III 期試驗的積極結果。

諾和諾德預計 2024 年將繼續成長,重點是擴大產能並覆蓋更多患者。他們討論了他們對糖尿病患者的承諾以及優化他們的產品組合。

該公司報告稱,其抗肥胖治療藥物 Wegovy 的停留時間更長,退出率也更低。他們對自己的研究進展及其管道產品的心血管益處表示信心。

諾和諾德計劃擴大其製造能力,並強調彈性供應鏈的重要性。他們對自己的表現感到滿意,並對未來的計劃感到興奮。

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 2023 Novo Nordisk Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

    美好的一天,感謝您的支持。歡迎參加諾和諾德 2023 年第四季財報電話會議。 (操作員指示)請注意,今天的會議正在錄製中。

  • I would now like to hand the conference over to your speaker today, Daniel Bohsen, CVP and Investor Relations. Please go ahead.

    現在我想將會議交給今天的發言人、首席副總裁兼投資者關係丹尼爾·博森 (Daniel Bohsen)。請繼續。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Welcome to this Novo Nordisk Earnings Call for the full year of 2023 and the outlook for 2024. My name is Daniel Muusmann Bohsen and I'm the Head of Investor Relations at Novo Nordisk.

    歡迎參加諾和諾德 2023 年全年收益電話會議以及 2024 年展望。我叫 Daniel Muusmann Bohsen,是諾和諾德投資者關係主管。

  • With me today I have CEO of Novo Nordisk, Lars Fruergaard Jorgensen; 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.

    今天和我在一起的還有諾和諾德 (Novo Nordisk) 執行長 Lars Fruergaard Jorgensen;執行副總裁兼商業策略與企業事務主管 Camilla Sylvest;執行副總裁兼北美營運主管 Doug Langa;執行副總裁兼開發主管 Martin Holst Lange;最後是財務長 Karsten Munk Knudsen。

  • All speakers will be available for the Q&A session. Today's announcement and the slides for this call are available on our website, novonordisk.com. Please note that the call is being webcast live and a recording will be made available on our website as well. The call is scheduled to last 1 hour.

    所有演講者都將參加問答環節。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 上取得。請注意,此通話正在進行網路直播,錄音也將在我們的網站上提供。通話預計為期 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.

    請翻到下一張投影片。此簡報的結構如投影片 2 所示。請注意,除非另有說明,所有銷售和營業利潤成長報表均採用固定匯率。

  • Please turn to Slide 3. We 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 2023 and the slides prepared for this presentation.

    請參閱投影片 3。我們需要通知您,本次電話會議將包含前瞻性陳述。這些都存在風險和不確定性,可能導致實際結果與預期有重大差異。有關風險因素的更多信息,請參閱公司 2023 年全年公告以及為本次演示準備的幻燈片。

  • With this, over to you Lars, for an update on our strategic aspirations.

    拉斯,請您了解我們策略願景的最新情況。

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

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

  • Thank you, Daniel. Please turn to the next slide. In 2023, we delivered double-digit sales and operating profit growth and we continue to make progress on our strategic aspirations. I'll walk you through the performance highlights, before handing over the word to my colleagues.

    謝謝你,丹尼爾。請翻到下一張投影片。 2023 年,我們實現了兩位數的銷售額和營業利潤成長,並繼續在我們的策略目標上取得進展。在將訊息交給我的同事之前,我將向您介紹效能亮點。

  • We continue making progress on Purpose and Sustainability. On carbon emissions, our carbon emissions decreased by 34% compared to pre-pandemic levels in 2019. And in 2023, we reached more than 40 million patients without diabetes and obesity treatments. To uphold our commitment to being a sustainable employer, We expanded the number of women in senior leadership positions to 41%, compared to 39% at the end of '22.

    我們繼續在目標和可持續性方面取得進展。在碳排放方面,與 2019 年大流行前的水平相比,我們的碳排放量下降了 34%。到 2023 年,我們涵蓋了超過 4,000 萬名沒有接受糖尿病和肥胖症治療的患者。為了履行我們成為永續雇主的承諾,我們將擔任高階領導職位的女性人數從 2022 年底的 39% 增加到 41%。

  • In the past year, we've developed and expanded our pipeline across all our therapy areas. In diabetes and obesity, we have seen several exciting trial readouts, and we have advanced novel assets into Phase III. We've also expanded our footprint in cardiovascular disease and strengthened our late-stage pipeline in rare blood disorders. Martin will come back to this and our overall R&D milestones later.

    在過去的一年裡,我們開發並擴展了所有治療領域的產品線。在糖尿病和肥胖症方面,我們看到了一些令人興奮的試驗結果,並且我們已將新資產推進到 III 期。我們也擴大了在心血管疾病領域的業務,並加強了罕見血液疾病的後期研發管線。馬丁稍後將回到這一點以及我們的整體研發里程碑。

  • In 2023, we have achieved 2 major milestones within commercial execution. We have reached our obesity sales operation of more than DKK 25 billion and our aspiration for diabetes, which was to achieve 1/3 of the global diabetes value market.

    2023 年,我們在商業執行上實現了 2 個重大里程碑。我們的肥胖症銷售額已超過 250 億丹麥克朗,我們對糖尿病的願景是佔據全球糖尿病價值市場的 1/3。

  • Going forward, we continue to aim for treating more patients with our innovative treatments. Lastly, we're very pleased with the strong sales growth of 36% and operating profit growth of 44% in 2023, both measured at constant exchange rates.

    展望未來,我們持續致力於透過創新療法治療更多患者。最後,我們對 2023 年銷售額強勁成長 36% 和營業利潤成長 44% 感到非常高興,兩者均以固定匯率計算。

  • Now I would like to hand over the word to Camilla, who will give us the latest update on our commercial execution.

    現在我想把話交給卡米拉,她將為我們提供有關商業執行的最新資訊。

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

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

  • Thank you, Lars. And please turn to the next slide. In 2023, our total sales increased by 36%. The sales growth was driven by both operating units with North America operations growing 54% and international operations growing 16%. Our GLP-1 sales in diabetes increased 52%, driven by North America growing 52% and international operations growing 53%.

    謝謝你,拉爾斯。請翻到下一張投影片。 2023年,我們的總銷售額成長了36%。銷售成長由兩個營運部門推動,其中北美業務成長 54%,國際業務成長 16%。在北美成長 52% 和國際業務成長 53% 的推動下,我們在糖尿病領域的 GLP-1 銷售額成長了 52%。

  • Insulin sales decreased by 6%, driven by declining sales in the U.S. and region China. Obesity care sales grew 154% and international operations sales grew 47%, driven by both Saxenda and Wegovy. Sales of Saxenda increased by 14% and sales of Wegovy reached around DKK 2 billion. Going forward, we continue to rollout Wegovy in a sustainable manner by volume cap launches to balance supply and demand.

    由於美國和中國地區銷售額下降,胰島素銷售額下降了 6%。在 Saxenda 和 Wegovy 的推動下,肥胖護理銷售額成長了 154%,國際業務銷售額成長了 47%。 Saxenda 銷售額成長 14%,Wegovy 銷售額達到約 20 億丹麥克朗。展望未來,我們將繼續以可持續的方式推出 Wegovy,透過推出數量上限來平衡供需。

  • In North America operations, obesity care sales grew 212%. Total rare disease sales decreased by 15%, which was driven by a 24% decrease in international operations and by a 1% decrease in North America operations, following a reduction in supply of Norditropin.

    在北美業務中,肥胖護理產品的銷售額成長了 212%。罕見疾病總銷售額下降了 15%,這是由於 Norditropin 供應減少導致國際業務下降 ​​24%,以及北美業務下降 ​​1%。

  • Please turn to the next slide. With 29% sales growth in diabetes care, we are growing faster than the total diabetes market. As a result, our global diabetes value market share increased to 33.8%, which is above our strategic aspiration of reaching 1/3 of the global diabetes value market. This increase reflects market share gains in both North America operations and international operations.

    請翻到下一張投影片。糖尿病照護領域的銷售額成長了 29%,我們的成長速度超過了整個糖尿病市場。由此,我們的全球糖尿病價值市佔率增至33.8%,高於我們達到全球糖尿病價值市場1/3的策略意願。這一增長反映了北美業務和國際業務的市場份額增長。

  • Please turn to the next slide. In international operations, total diabetes care sales increased by 20% in 2023, which was primarily driven by GLP-1 sales growing 53%. Novo Nordisk is the market leader in international operations, with a GLP-1 value market share over 70%. Ozempic continues its GLP-1 market leadership with 47.5% market share. Rybelsus has just shy of 14% value market share, driven by solid uptake across geographies.

    請翻到下一張投影片。在國際業務中,2023 年糖尿病護理總銷售額增長了 20%,這主要是由 GLP-1 銷售額增長 53% 推動的。諾和諾德是國際業務的市場領導者,其 GLP-1 價值市場佔有率超過 70%。 Ozempic 以 47.5% 的市佔率繼續保持其 GLP-1 市場領先地位。在各個地區的強勁應用的推動下,Rybelsus 的價值市場佔有率略低於 14%。

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

    接下來,我將把這個字交給道格。

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

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

  • Thank you, Camilla. Please turn to the next slide. In the U.S. sales growth of our GLP-1 diabetes treatments are driven by a 50% expansion of the market in 2023 versus 2022.

    謝謝你,卡米拉。請翻到下一張投影片。在美國,我們的 GLP-1 糖尿病治療藥物的銷售成長是由 2023 年市場比 2022 年擴大 50% 所推動的。

  • In the fourth quarter of 2023, the prescription volume growth of the GLP-1 class was more than 30%, compared to the fourth quarter of 2022. Measured on total prescriptions, Novo Nordisk continues to be the market leader with around 54% market share.

    2023年第四季,GLP-1類藥物的處方量較2022年第四季成長超過30%。以總處方量衡量,諾和諾德持續維持市場領先地位,市佔率約54% 。

  • Please go to the next slide. Obesity care sales grew by 154%, driven by both operating units. The volume growth of the global branded obesity market more than doubled with a volume growth of 116%. In International operations, obesity care sales are driven by a strong Saxenda performance and the Wegovy launches in 7 international operation countries.

    請轉到下一張投影片。在兩個營運部門的推動下,肥胖護理銷售額成長了 154%。全球品牌肥胖市場的銷售量成長了一倍多,成長 116%。在國際業務中,肥胖護理產品的銷售受到 Saxenda 強勁表現的推動,並且 Wegovy 在 7 個國際業務國家推出。

  • In the U.S., sales of Wegovy grew by 393%, reflecting the commercial relaunch in January of 2023. To safeguard continuity of care, we reduced the release of lower dose strengths back in May of 2023, which continued throughout the remainder of last year. I am very pleased to state that we are now enabling more new U.S. patients to initiate treatment by more than doubling the amount of the lower dose strengths of Wegovy, compared to the previous months. We will gradually be increasing the overall supply throughout the remainder of 2024.

    在美國,Wegovy 的銷售額成長了393%,這反映了2023 年1 月的商業重新啟動。為了保證護理的連續性,我們早在2023 年5 月就減少了較低劑量規格的發布,這種情況在去年剩餘時間一直持續著。我很高興地宣布,與前幾個月相比,我們現在透過將 Wegovy 的低劑量劑量增加一倍以上,讓更多的美國新患者能夠開始治療。我們將在 2024 年剩餘時間內逐步增加整體供應量。

  • Please go to the next slide. Our rare disease sales decreased by 15%. The sales decrease was driven by a 1% sales decline in North America operations, and 24% sales decline in international operations. Sales of rare blood disorders increased by 3%, driven by the launch products in haemophilia A and B and partially countered by NovoSeven. Sales of our rare endocrine disorder products decreased by 47%, reflecting a reduction in manufacturing output.

    請轉到下一張投影片。我們的罕見疾病銷售額下降了 15%。銷售額下降的原因是北美業務銷售額下降 1%,國際業務銷售額下降 24%。罕見血液疾病的銷售額增加了 3%,這得益於 A 型和 B 型血友病產品的推出,但受到 NovoSeven 的部分抵消。我們罕見的內分泌失調產品的銷售額下降了 47%,反映出製造業產量的減少。

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

    現在,馬丁,請您了解研發方面的最新情況。

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

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

  • Thank you, Doug. Please turn to the next slide. First, I'm very pleased to share the exciting headline results from the combined 3 trial with once weekly IcoSema. Combined 3 was a 52-week open-label treat-to-target Phase III trial, comparing once weekly IcoSema with once-daily insulin glargine U100 together with up to 4 daily injections of insulin aspart. This is also called basal-bolus insulin treatment.

    謝謝你,道格。請翻到下一張投影片。首先,我很高興與大家分享每週一次的 IcoSema 聯合 3 次試驗的令人興奮的標題結果。合併 3 是一項為期 52 週的開放標籤治療至目標 III 期試驗,將每週一次的 IcoSema 與每日一次的甘精胰島素 U100 以及每天注射最多 4 次的門冬胰島素進行比較。這也稱為基礎推注胰島素治療。

  • The objective of Combined 3 was to assess the efficacy and safety of once-weekly IcoSema in people with type 2 diabetes, poorly controlled on daily basal insulin. The trial achieved its primary endpoint of demonstrating non-inferiority in reducing A1c at week 52 with once weekly IcoSema, compared to insulin glargine U100 together with insulin aspart.

    Combined 3 的目的是評估每週一次 IcoSema 對每日基礎胰島素控制不佳的 2 型糖尿病患者的療效和安全性。該試驗達到了其主要終點,即與甘精胰島素 U100 和門冬胰島素相比,每週一次的 IcoSema 在第 52 週時降低 A1c 方面的非劣效性。

  • From an overall A1c baseline of 8.3%, once weekly IcoSema achieved an estimated reduction in HbA1c of 1.47 percentage points, compared with 1.40 percentage points for insulin glargine together with insulin aspart. People in the trial had a baseline body weight of 85.8 kilograms.

    從 8.3% 的整體 A1c 基線來看,每週一次 IcoSema 預計 HbA1c 降低了 1.47 個百分點,而甘精胰島素和門冬胰島素的降低幅度為 1.40 個百分點。參加試驗的人的基線體重為 85.8 公斤。

  • Treatment with IcoSema achieved a superior reduction in body weight with a weight loss of 3.6 kilograms with IcoSema, compared with 3.2 kilogram weight gain with the basal -- with the insulin basal-bolus treatment. The estimated treatment difference was 6.7 kilograms.

    IcoSema 治療實現了顯著的體重減輕,IcoSema 體重減輕了 3.6 公斤,而基礎胰島素推注治療則體重增加了 3.2 公斤。估計治療差異為 6.7 公斤。

  • IcoSema also showed superiority over insulin glargine U100 together with the insulin aspart in terms of severe, or clinically significant hypoglycemic events with only 0.26 events per patient year of exposure, compared to 2.18 events per patient year of exposure in the basal-bolus treatment arm. Overall, IcoSema appear to have a safe and well-tolerated profile.

    在嚴重或臨床上顯著的低血糖事件方面,IcoSema 也表現出優於甘精胰島素U100 和門冬胰島素的優勢,每位患者暴露年僅發生0.26 起事件,而基礎推注治療組中每位患者暴露年發生2.18 起事件。總體而言,IcoSema 似乎具有安全且耐受性良好的特性。

  • These Phase III results by once weekly IcoSema are very promising. For people with poorly controlled type 2 diabetes on basal insulin, IcoSema has the potential to streamline insulin intensification by addressing the main patient barriers. IcoSema sets a new standard for once weekly treatment by reducing the annual injections from around 1,450 to 52 injections.

    IcoSema 每週一次的 III 期結果非常有希望。對於基礎胰島素控制不佳的 2 型糖尿病患者,IcoSema 有潛力透過解決主要的患者障礙來簡化胰島素強化治療。 IcoSema 將每年的注射次數從約 1,450 次減少到 52 次,為每週一次的治療設定了新標準。

  • This substantial reduction in patient burden is provided together with a strong glycemic control, proper weight management, and importantly a factor of 10x lower rates of hypoglycemia as compared to the current gold standard of insulin basal-bolus treatment.

    患者負擔的大幅減輕與強有力的血糖控制、適當的體重管理一起提供,重要的是,與當前胰島素基礎推注治療的黃金標準相比,低血糖發生率降低了 10 倍。

  • Please turn to the next slide. Turning to the upcoming R&D milestones. There are many exciting trial results in 2024. However, before I get to that, I would like to highlight a few of the milestones from the fourth quarter of 2023. Within obesity, we've successfully completed 2 Phase III status with semaglutide 2.4 milligram addressing obesity-related comorbidities as well as the Phase I trial for oral amycretin.

    請翻到下一張投影片。轉向即將到來的研發里程碑。 2024 年將有許多令人興奮的試驗結果。不過,在此之前,我想強調2023 年第四季度的一些里程碑。在肥胖方面,我們已成功完成了2 個2.4 毫克索馬魯肽的III期臨床試驗解決與肥胖相關的合併症以及口服阿黴素的 I 期試驗。

  • Firstly STEP 9 trial was a Phase III knee osteoarthritis trial that investigated the effects of semaglutide 2.4 milligram once weekly on the co-primary endpoints of body weight and the Western Ontario and McMaster Universities Osteoarthritis Index, abbreviated WOMAC. This is a self-administered measurement used in assessing pain and functionality.

    首先,STEP 9 試驗是一項III 期膝骨關節炎試驗,研究每週一次2.4 毫克司馬魯肽對體重和西安大略大學和麥克馬斯特大學骨關節炎指數(縮寫為WOMAC)共同主要終點的影響。這是一種自我管理的測量,用於評估疼痛和功能。

  • In the trial, 407 people with obesity and mild-to-moderate knee osteoarthritis were enrolled. The study achieved its co-primary endpoint by demonstrating a superior reduction in both the WOMAC pain score as well as in body weight with semaglutide 2.4 milligram, compared to placebo. The estimated reduction in mean WOMAC pain score from baseline to week 68 was 41.7 with semaglutide 2.4 milligram and 27.5 with placebo.

    該試驗招募了 407 名患有肥胖症和輕度至中度膝骨關節炎的患者。該研究實現了其共同主要終點,證明與安慰劑相比,2.4 毫克索馬魯肽可顯著降低 WOMAC 疼痛評分和體重。從基線到第 68 週,索馬魯肽 2.4 毫克組的平均 WOMAC 疼痛評分估計降低 41.7 分,安慰劑組降低 27.5 分。

  • The estimated treatment difference was 14.1, which was not only statistically significant, but also considered clinically very relevant. The trial results will serve as a foundation for potential outcomes trials with future obesity assets.

    估計的治療差異為 14.1,這不僅具有統計顯著性,而且在臨床上也被認為非常相關。試驗結果將作為未來肥胖資產潛在結果試驗的基礎。

  • In addition, we've successfully completed the STEP HFpEF diabetes trial. The STEP HFpEF diabetes trial investigated impact of semaglutide treatment on functionality and symptoms in patients with obesity, type 2 diabetes, and established heart failure. In total 660 people were enrolled in the study. The co-primary endpoints were the average change from baseline in the Kansas City Cardiomyopathy clinical summary score questionnaire and body weight.

    此外,我們也成功完成了 STEP HFpEF 糖尿病試驗。 STEP HFpEF 糖尿病試驗調查了索馬魯肽治療對肥胖、2 型糖尿病和已確診心臟衰竭患者功能和症狀的影響。共有 660 人參加了這項研究。共同主要終點是堪薩斯城心肌病變臨床總結評分問捲和體重相對於基線的平均變化。

  • In the trial, semaglutide showed a 13.7 points improvement versus 6.4 in the placebo arm at 52 weeks. The mean change was 7.3 points in favor of semaglutide, which is considered clinically very relevant, and very solid results with chronic heart failure. A superior reduction in body weight was also observed for semaglutide 2.4 milligram versus placebo.

    在試驗中,52 週時索馬魯肽的改善為 13.7 分,而安慰劑組為 6.4 分。索馬魯肽的平均變化為 7.3 分,這被認為在臨床上非常相關,並且對慢性心臟衰竭有非常可靠的結果。與安慰劑相比,2.4 毫克索馬魯肽也顯著減輕了體重。

  • We've submitted the results from the STEP HFpEF obesity trial as well as the type 2 diabetes trial for regulatory review in U.S. and Europe during the course of January of '24. This marks another milestone in our ongoing efforts to address the unmet medical needs in patients with overweight, obesity, and established cardiovascular disease.

    我們已於 2024 年 1 月提交了 STEP HFpEF 肥胖試驗以及 2 型糖尿病試驗的結果,以供美國和歐洲的監管審查。這標誌著我們持續努力解決超重、肥胖和既定心血管疾病患者未滿足的醫療需求的另一個里程碑。

  • The last highlight for the fourth quarter of 2023 is the successful completion of oral amycretin Phase I. This trial appear to have a safe and well tolerated profile for amycretin. We have decided in September of 2023 to also initiate a Phase I trial with once weekly subcutaneous amycretin and further we expect to advance amycretin into further clinical development.

    2023 年第四季的最後一個亮點是口服阿黴素 I 期臨床試驗的成功完成。該試驗似乎對阿黴素具有安全性和良好的耐受性。我們決定在 2023 年 9 月啟動每週一次皮下注射阿黴素的 I 期試驗,並且我們預計將阿黴素進一步推進臨床開發。

  • Moving forward to 2024, within diabetes care, we expect a decision on approval of insulin icodec in Europe, Japan, China as well as the U.S. during the second half of 2024. We are also anticipating the exciting results of COMBINE 1 and COMBINE 2 from the IcoSema development program during the initial half of 2024.

    展望 2024 年,在糖尿病治療領域,我們預計 2024 年下半年歐洲、日本、中國和美國將做出批准胰島素 icodec 的決定。我們也期待 COMBINE 1 和 COMBINE 2 的令人興奮的結果2024 年上半年的IcoSema 開發計劃。

  • Of note, we are expecting the Phase I results of the once-weekly GLP-1/GIP in the first half of '24, and we've further initiated a Phase I trial with once-monthly GLP-1/GIP during the course of January of '24.

    值得注意的是,我們預計每週一次的 GLP-1/GIP 的 I 期結果將在 24 年上半年公佈,並且在此期間我們進一步啟動了每月一次的 GLP-1/GIP 的 I 期試驗' 24 年1 月。

  • We continue to build evidence for the semaglutide molecule within diabetes as well. For subcutaneous semaglutide 1.0 milligram, we anticipate the readout of FLOW for people with Type 2 diabetes and chronic kidney disease in the first half of this year.

    我們也持續為糖尿病中的索馬魯肽分子建立證據。對於皮下注射 1.0 毫克索馬魯肽,我們預計今年上半年將公佈 2 型糖尿病和慢性腎臟病患者的 FLOW 讀數。

  • This will be followed by the functional outcomes trial STRIDE, for people with type 2 diabetes and peripheral artery disease in the second half of 2024. As far as semaglutide, the cardiovascular outcome study, SOUL, is expected to be completed in the second half of 2024, indicating semaglutide in people with diabetes and cardiovascular disease.

    隨後將在 2024 年下半年針對 2 型糖尿病和周邊動脈疾病患者進行功能結果試驗 STRIDE。就索馬魯肽而言,心血管結果研究 SOUL 預計將於 2024 年下半年完成2024 年,顯示索馬魯肽可用於糖尿病和心血管疾病患者。

  • In obesity area, we expect an FDA decision on the approval of the SELECT data submission, in the first half of '24. Furthermore, we look forward to the first Phase III readout for CagriSema towards the turn of the year.

    在肥胖領域,我們預計 FDA 將在 24 年上半年做出批准 SELECT 資料提交的決定。此外,我們期待在今年年初發布 CagriSema 的第一個 III 期數據。

  • And as a last highlight, we are very excited about the upcoming readout of Mim8 Phase III in the first half of 2028. Mim8 is a novel next generation factor VIII mimetic antibody with potential for improved patient outcomes and reduced burden of treatment in people with hemophilia A.

    最後一個亮點是,我們對即將在2028 年上半年公佈的Mim8 III 期結果感到非常興奮。Mim8 是一種新型的下一代VIII 因子模擬抗體,有可能改善患者的治療結果並減輕血友病患者的治療負擔A。

  • With that, over to you, Karsten.

    就這樣,交給你了,卡斯滕。

  • 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 2023, our sales grew by 31% in Danish kroner and 36% at constant exchange rates, driven by both operating units. The gross margin increased to 84.6%, compared to 83.9% in 2022 driven by a positive product mix following increased sales of injectable GLP-1-based treatments.

    謝謝你,馬丁。請翻到下一張投影片。 2023 年,在兩個營運部門的推動下,我們的銷售額(以丹麥克朗計算)成長了 31%,以固定匯率計算成長了 36%。毛利率從 2022 年的 83.9% 增加至 84.6%,原因是基於注射 GLP-1 的治療藥物銷量增加,產品組合積極。

  • Costs related to ongoing capacity expansions and negative currency impact and lower realized prices mainly in the U.S. and Region China partially offset these effects. Sales and distribution costs increased by 23% in Danish kroner and by 26% at constant exchange rates. The increase is driven by both operating units.

    與持續產能擴張相關的成本、負面貨幣影響以及主要在美國和中國地區實現價格下降部分抵消了這些影響。以丹麥克朗計算的銷售和分銷成本增加了 23%,以固定匯率計算則增加了 26%。這一增長是由兩個營運單位推動的。

  • In North America operations, cost increase is driven by the relaunch of Wegovy and promotional activities for Ozempic, while in international operations, cost increase is driven by promotional activities for Rybelsus as well as obesity care market development activities. Furthermore, the increase in sales and distribution costs are impacted by adjustments to legal provisions.

    在北美業務中,成本增加是由 Wegovy 的重新推出和 Ozempic 的促銷活動推動的,而在國際業務中,成本增加是由 Rybelsus 的促銷活動以及肥胖護理市場開發活動推動的。此外,銷售和分銷成本的增加也受到法律規定調整的影響。

  • Research and development costs increased by 35% measured in Danish kroner and 37% at constant exchange rates. The increase reflects our strategic objective to expand the pipeline across therapy areas. Specifically, we continue to increase late-stage clinical trial and early research activities. The acquisition of Forma Therapeutics in 2022 and Inversago Pharma also increased R&D spending.

    以丹麥克朗計算的研發成本增加了 35%,以固定匯率計算則增加了 37%。這一增長反映了我們擴大治療領域產品線的策略目標。具體來說,我們繼續增加後期臨床試驗和早期研究活動。 2022年收購Forma Therapeutics和Inversago Pharma也增加了研發支出。

  • Administration costs increased by 9%, measured in Danish kroner and by 11% at constant exchange rates. Operating profit increased by 37% measured in Danish kroner and by 44% at constant exchange rates, reflecting the sales growth.

    以丹麥克朗計算的管理成本增加了 9%,以固定匯率計算則增加了 11%。以丹麥克朗計算的營業利潤成長了 37%,以固定匯率計算的營業利潤成長了 44%,反映了銷售的成長。

  • Net financial items showed a gain of DKK 2.1 billion, compared to a net loss of around DKK 5.7 billion last year. The effective tax rate is 20.1% in 2023, compared to 19.6% in 2022. Consequently, net profit increased by 51% and diluted earnings per share increased by 52% to DKK 18.62.

    金融計畫淨額成長 21 億丹麥克朗,去年淨虧損約 57 億丹麥克朗。 2023 年的有效稅率為 20.1%,而 2022 年為 19.6%。因此,淨利潤成長 51%,稀釋每股收益成長 52%,達到 18.62 丹麥克朗。

  • Free cash flow realized in 2023 was DKK 68.3 billion, compared with DKK 57.4 billion in 2022. This is in line with the strategic aspiration to deliver attractive capital allocation to shareholders. The cash conversion in 2023 was positively impacted by timing of payment of rebates in the U.S. and provisions related to the revised 340B distribution policy, also in the U.S.

    2023 年實現的自由現金流為 683 億丹麥克朗,而 2022 年為 574 億丹麥克朗。這符合為股東提供有吸引力的資本配置的戰略願景。 2023 年的現金轉換受到美國回扣支付時間以及與美國修訂後的 340B 分配政策相關的規定的正面影響。

  • Capital expenditure for property, plant, and equipment was DKK 25.8 billion compared with DKK 12.1 billion in 2022. This primarily reflects investments in additional capacity for active pharmaceutical ingredient production and for finish capacity, for both current and future injectable and oral products.

    物業、廠房和設備的資本支出為 258 億丹麥克朗,而 2022 年為 121 億丹麥克朗。這主要反映了對當前和未來注射劑和口服產品的活性藥物成分生產和成品產能的額外產能的投資。

  • Please go to the next slide. In 2024, we expect to increase our capital expenditure to around DKK 45 billion. A significant step up compared to 2023, reflects the expansion of our supply chain. This includes the previously communicated expansions of manufacturing facilities in Kalundborg and Hillerod locations in Denmark and Chartres based in France.

    請轉到下一張投影片。 2024 年,我們預計將資本支出增加至 450 億丹麥克朗左右。與 2023 年相比,這是一個顯著的進步,反映出我們供應鏈的擴張。這包括先前通報的丹麥卡倫堡和希勒勒以及法國沙特爾製造工廠的擴建。

  • The increase in capital expenditure in 2024 mainly relates to investments in additional capacity for active pharmaceutical ingredient production and for the finish capacity for both current and future injectable and oral products across our strategic therapy areas. In the coming years, the capital expenditure to sales ratio is still expected to be low double-digits.

    2024 年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我們戰略治療領域當前和未來注射劑和口服產品的成品產能的投資。未來幾年,資本支出與銷售額的比率預計仍將維持在兩位數的低點。

  • Next slide, please. In line with our strategic aspiration to deliver attractive capital allocation to shareholders, we have returned more than DKK 61.7 billion to shareholders via share buybacks and dividends during 2023. At the annual general meeting on March 21, of 2024, the Board of Directors will propose a final dividend of DKK 6.40 for a total of 2023 dividend of DKK 9.40 including the interim dividend paid in August of 2023.

    請下一張投影片。根據我們向股東提供有吸引力的資本配置的戰略願景,我們在2023 年透過股票回購和股息向股東返還了超過617 億丹麥克朗。在2024 年3 月21 日的年度股東大會上,董事會將提議末期股息為 6.40 丹麥克朗,2023 年股息總計為 9.40 丹麥克朗,包括 2023 年 8 月支付的中期股息。

  • This is over a 50% increase compared to 2022, making it the 28th consecutive year with increasing dividend per share. In addition to the dividends, the DKK 30 billion share buyback for the past 12 months has been concluded. For 2024, the Board of Directors has approved a new share repurchase program of up to DKK 20 billion to be executed during the coming 12 months.

    與 2022 年相比增長了 50% 以上,使其成為每股股息連續第 28 年增加。除股利外,過去12個月300億丹麥克朗的股票回購也已結束。董事會已批准 2024 年高達 200 億丹麥克朗的新股票回購計劃,並將在未來 12 個月內執行。

  • Next slide please. We continued the growth momentum in 2024 and expect the sales growth to be between 18% and 26% at constant exchange rates. This is based on several assumptions as described in the company announcements. The guidance reflects expectations for sales growth in both North America operations and international operations.

    請下一張投影片。我們在2024年持續維持成長勢頭,預計以固定匯率計算銷售額成長將在18%至26%之間。這是基於公司公告中描述的幾個假設。該指引反映了對北美業務和國際業務銷售成長的預期。

  • The sales growth is expected to be mainly driven by volume growth of GLP-1 based treatments for obesity and diabetes care. With the expectations of continued volume growth and capacity limitations, the outlook also reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.

    預計銷售成長將主要受到基於 GLP-1 的肥胖和糖尿病治療療法銷售成長的推動。考慮到銷售持續成長和產能限制的預期,該前景還反映出預計持續的周期性供應限制以及多個產品和地區的相關藥品短缺通知。

  • We expect that operating profit will grow between 21% and 29% at constant exchange rates. This primarily reflects the sales growth outlook and continued investments in future and current growth drivers within research, development, and commercial.

    我們預計,以固定匯率計算,營業利潤將成長 21% 至 29%。這主要反映了銷售成長前景以及對研究、開發和商業領域未來和當前成長動力的持續投資。

  • Our reported sales are expected to be 1 percentage point lower at constant exchange rates and operating profit is expected to be 2 percentage points lower than at constant exchange rates.

    以固定匯率計算,我們報告的銷售額預計將下降 1 個百分點,營業利潤預計將比以固定匯率計算下降 2 個百分點。

  • For 2024, we expect net financial items to amount to a gain of around DKK 1.3 billion. This mainly reflects gains associated with foreign exchange hedging contracts as well as interest rate gains from cash and marketable securities. The free cash flow is expected to be between DKK 64 billion and DKK 74 billion, reflecting the sales growth, a favorable impact from rebates in the U.S., countered by investments in capital expenditure.

    2024 年,我們預計財務項目淨收益將達到約 13 億丹麥克朗。這主要反映了與外匯對沖合約相關的收益以及現金和有價證券的利率收益。自由現金流預計在 640 億丹麥克朗至 740 億丹麥克朗之間,反映了銷售成長、美國回扣的有利影響以及資本支出投資的抵消。

  • That covers the outlook for 2024. Now back to you, Lars.

    這涵蓋了 2024 年的展望。現在回到你身上,拉斯。

  • 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 strong performance in 2023, which reflects that more than 40 million people are now benefiting from our innovative diabetes and obesity treatments. We continue to make progress on our strategic aspirations. In 2024, our focus will be on the continued significant expansion of our production capacity, reaching more patients and are progressing the expanding pipeline.

    謝謝你,卡斯滕。請翻到最後一張投影片。我們對 2023 年的強勁表現感到非常滿意,這反映出目前有超過 4000 萬人從我們創新的糖尿病和肥胖治療中受益。我們繼續在我們的戰略願景上取得進展。 2024 年,我們的重點將是繼續大幅擴大我們的產能,涵蓋更多患者,並正在推動不斷擴大的產品線。

  • With that, I would like to hand the word back to Daniel.

    說到這裡,我想把話交還給丹尼爾。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Lars. Next slide please. With that, we're now ready for the Q&A. We kindly ask all participants to limit her or himself to 1 or maximum 2 questions. This includes sub questions. Operator, we're now ready to take the first question.

    謝謝你,拉爾斯。請下一張投影片。至此,我們現在準備好要進行問答了。我們懇請所有參與者將自己的問題限制在 1 個或最多 2 個。這包括子問題。接線員,我們現在準備回答第一個問題。

  • Operator

    Operator

  • (Operator Instructions) And the first question comes from the line of Mike Nedelcovych from TD Cowen.

    (操作員說明)第一個問題來自 TD Cowen 的 Mike Nedelcovych。

  • Michael Thomas Nedelcovych - Research Associate

    Michael Thomas Nedelcovych - Research Associate

  • I have 2 for Martin. The first is on the GLP-1/GIP dual agonist. As it relates to the clinical profile of a once-monthly injection, it seems to me that navigating GI toxicity during the titration phase with a drug that's on board for an entire month could be tricky. Do you think that's a valid concern, and if so might undercut to some extent that convenience advantage? And then my second question is on oral amycretin. Can you provide any insight into the efficacy, you saw in the Phase I trial. A reasonable ambition would be for weight loss at approaches that delivered by CagriSema, but via the oral route, how close did amycretin get to that profile?

    我有 2 個給馬丁。第一個是 GLP-1/GIP 雙重激動劑。由於它與每月一次注射的臨床特徵有關,在我看來,在滴定階段使用整整一個月的藥物來控制胃腸道毒性可能會很棘手。您認為這是一個合理的擔憂嗎?如果是的話,可能會在某種程度上削弱便利優勢?我的第二個問題是關於口服阿黴素。您能否提供任何關於您在第一階段試驗中看到的功效的見解?合理的目標是透過 CagriSema 提供的方法來實現減肥,但透過口服途徑,阿黴素離這個目標有多近?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Mike. And Martin, over to you.

    謝謝你,麥克。馬丁,交給你了。

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

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

  • Yes, thank you. Thank you for those questions. First of all on the once monthly GLP-1/GIP, honestly speaking, we asked ourselves the same questions when we moved from one daily to once weekly and this is all in the focus of titration. So proper titration will mitigate most GI tolerability side effects. And therefore we are quite confident that we can manage a once-monthly in that setting. We actually didn't see an increase moving from once daily to once weekly, and we don't expect to see that moving from once weekly to once monthly.

    是的,謝謝。謝謝你提出這些問題。首先,關於每月一次的 GLP-1/GIP,老實說,當我們從每天一次改為每週一次時,我們問了自己同樣的問題,這都是滴定的重點。因此,適當的滴定可以減輕大多數胃腸道耐受性副作用。因此,我們非常有信心在這種情況下能夠管理每月一次的活動。實際上,我們沒有看到從每天一次增加到每週一次的情況,我們也不希望看到從每週一次增加到每月一次的情況。

  • On the amycretin, we're not disclosing Phase I data, but you should obviously read into the fact that we are stating that we are progressing further development, which also means that we believe amycretin to be properly differentiated to whatever else is out there.

    關於阿黴素,我們不會透露第一階段的數據,但您顯然應該了解這樣一個事實:我們正在聲明我們正在進一步開發,這也意味著我們相信阿黴素與其他任何藥物都有適當的區別。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Mike. For the question. Thanks for being up early. Next question, please.

    謝謝你,麥克。對於這個問題。謝謝你早起。請下一個問題。

  • Operator

    Operator

  • And the next question comes from the line of Peter Verdult from Citigroup.

    下一個問題來自花旗集團的 Peter Verdult。

  • Peter Verdult - MD

    Peter Verdult - MD

  • Yes, thanks, Peter Verdult, Citi. Three questions please for Lars or Karsten. You've mentioned many times Novo management's #1 priority is scaling supply. I just want to try and marry that with the comments you provided for '24 and guidance. I mean if I just annualize your exit run rate Q4 2023, you pretty much are at the bottom end of 2024 guidance. And I realize there is FX and there is rebate to consider, but I did want to push my luck and try and get a handle how significantly capacity will increase in 2024. Especially in light of SELECT coming on the label this year, and likely increasing demand further.

    是的,謝謝花旗銀行的 Peter Verdult。請問 Lars 或 Karsten 三個問題。您多次提到 Novo 管理階層的第一要務是擴大供應規模。我只是想嘗試將其與您為 '24 提供的評論和指導結合起來。我的意思是,如果我僅將 2023 年第四季的退出運行率按年計算,那麼您幾乎處於 2024 年指導的底部。我意識到有外匯,也有回扣需要考慮,但我確實想碰碰運氣,嘗試了解 2024 年容量將顯著增加。特別是考慮到今年 SELECT 即將出現在標籤上,並且可能會增加進一步要求。

  • And then secondly is for Karsten, just a quick play on the revenue recognition from 340B pharmacies. I know you currently only partially revenue recognized, and that's what's baked into guidance, but I thought there was a chance that could change in 2023, given that you had prevailed in litigation with HHS. So could there be any change in your stance on 340B in '24 and am I right that were you to fully revenue recognized that could actually have quite a meaningful uplift to Novo earnings around 5%?

    其次是 Karsten,簡單介紹一下 340B 藥局的收入確認。我知道你們目前只確認了部分收入,這就是納入指導的內容,但我認為考慮到你們在與 HHS 的訴訟中勝訴,我認為 2023 年情況可能會發生變化。那麼,您在 24 年對 340B 的立場是否會發生任何變化?如果您完全確認收入,這實際上可能會對 Novo 收益帶來 5% 左右的相當有意義的提升,我說得對嗎?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Pete. Karsten, 2 questions for you.

    謝謝你,皮特。卡斯滕,問你兩個問題。

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

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

  • Yes, so first as to our 2024 guidance. Then the important point is that we are continuing the growth trajectory, we showed already in 2023. And just to remind you, 36% sales growth adding to the tune of 5 million people on Novo products over 12-month periods. So we do believe that that's significant scaling, and in round numbers we're talking about that magnitude when you look at our scaling into next year.

    是的,首先是我們 2024 年的指導。然後重要的一點是,我們正在繼續我們在 2023 年展示的成長軌跡。只是提醒您一下,在 12 個月內,Novo 產品的使用人數達到 500 萬人,銷售額增長了 36%。因此,我們確實相信這是一個重大的擴展,當你看到我們明年的擴展時,我們正在以整數形式談論這個規模。

  • So it's a similar type scaling we'll be doing in 2024. I don't like necessarily -- the logic between multiplying Q4 by 4, because we were in a chronic disease business. So all the ups and downs of currencies and inventories in one quarter, makes it dangerous to annualize, just based on 3 months. So but again the growth platforms remain the same. It's Rybelsus, it's Ozempic and Wegovy

    因此,我們將在 2024 年進行類似的擴展。我不一定喜歡將第四季度乘以 4 的邏輯,因為我們從事的是慢性病業務。因此,一個季度內貨幣和庫存的所有漲跌,使得僅基於 3 個月進行年化變得危險。因此,成長平台仍保持不變。這是 Rybelsus、Ozempic 和 Wegovy

  • And we're scaling those -- all of those 3 platforms, which is what gives us the guidance that we provided today. And then as to 340B, you're right as we stated, we are only partially recognizing 340B revenue and that's linked to the accounting standards of, in order to recognize revenue, it has to be what the accountants, or the auditors call highly profitable. So that's the backdrop behind that.

    我們正在擴展這些——所有這 3 個平台,這就是我們今天提供的指導。然後至於 340B,正如我們所說,你是對的,我們只是部分確認了 340B 收入,這與會計標準相關,為了確認收入,它必須是會計師或審計師所說的高利潤。這就是背後的背景。

  • And yes, we prevailed in our case back in January of '23. There are still 2 cases outstanding in different jurisdictions around the same question. So that would be key informative points for us to decide on, how to proceed forward vis-a-vis our constant recognition in this space.

    是的,我們在 2023 年 1 月的案件中勝訴了。圍繞著同一問題,不同司法管轄區仍有兩起懸而未決的案件。因此,這將是我們決定如何繼續前進的關鍵資訊點,以應對我們在這一領域的不斷認可。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Pete. Thank you. Karsten. And next question, please.

    謝謝你,皮特。謝謝。卡斯滕.請提出下一個問題。

  • Operator

    Operator

  • And the next question comes from the line of Louise Chen from Cantor.

    下一個問題來自 Cantor 的 Louise Chen。

  • Louise Alesandra Chen - MD & Senior Research Analyst

    Louise Alesandra Chen - MD & Senior Research Analyst

  • So my first question is, how do you think about the launch of Lilly Zepbound in your guidance for 2024? And then second question is, when do you expect to report data from your NASH or MASH studies such as your ESSENCE study or your FGF21?

    所以我的第一個問題是,您如何看待 2024 年指導中 Lilly Zepbound 的推出?第二個問題是,您預計何時報告 NASH 或 MASH 研究(例如 ESSENCE 研究或 FGF21)的數據?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Louise. Karsten, I'll give the first to you with guidance and then Martin, later you on the MASH.

    謝謝你,路易絲。 Karsten,我將首先為您提供指導,然後是 Martin,然後是 MASH 上的您。

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

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

  • Yes. So as always when forecasting, then we take into account demand in the market, competition and supply capacity. So those factors what we have weighed into guidance both in terms of the pricing environment in the U.S. to maintain high degree of formulary access at PBM basis. And then on the volume basis, I would say that it's more question, about supply capacity since we are not competing for share given the magnitude of the markets.

    是的。因此,在預測時,我們會一如既往地考慮市場需求、競爭和供應能力。因此,我們在美國的定價環境方面權衡了這些因素,以在 PBM 的基礎上保持高度的處方准入。然後,在數量的基礎上,我想說,這更多是關於供應能力的問題,因為考慮到市場的規模,我們不會爭奪份額。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Karsten. And over to Martin.

    謝謝你,卡斯滕。接下來是馬丁。

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

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

  • Yes, thank you very much. So for the ESSENCE NASH study, we expect to see a read out around the turn of this year and then progress towards the regulatory finding. The FGF21 study is a Phase II trial, actually also investigating the effect of CagriSema and NASH and we'll see that read out a little bit later.

    是的謝謝你。因此,對於 ESSENCE NASH 研究,我們預計將在今年年初看到結果,然後朝著監管發現取得進展。 FGF21 研究是一項 II 期試驗,實際上也研究了 CagriSema 和 NASH 的影響,我們稍後會看到結果。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Martin. And we are ready for the next question.

    謝謝你,馬丁。我們準備好回答下一個問題了。

  • Operator

    Operator

  • And the next question comes from the line of Sachin Jain from Bank of America.

    下一個問題來自美國銀行的 Sachin Jain。

  • Sachin Jain - MD & Research Analyst

    Sachin Jain - MD & Research Analyst

  • Sachin Jain here from Bank of America. Firstly, just on amycretin, back to you Martin, the plan to progress your commentary is very vague, particularly for the oral formulation. So we're not going to just ask you why you're being vague at the moment and the factors that go into that decision. One would assume an oral CagriSema would be exciting, so why not commit, so ask just what are you waiting for? And then the second question on supply. Thank you for the color on doubling of the lower doses that we'll give in the coming months. Should I assume there's ability to further supply of the lower dose versus doubling the limits for full year '24?

    來自美國銀行的 Sachin Jain。首先,關於阿黴素,馬丁,您的評論進展計劃非常模糊,特別是對於口頭製劑。因此,我們不會只是問您為什麼目前含糊其辭以及影響該決定的因素。人們可能會認為口頭 CagriSema 會令人興奮,所以為什麼不承諾,所以問問你還在等什麼?然後是關於供應的第二個問題。感謝您對我們將在未來幾個月內給予的較低劑量加倍的顏色。我是否應該假設有能力進一步供應較低劑量,而不是將 24 年全年限制加倍?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Sachin. So Martin, first to you and then Karsten, you'll take the supply question.

    謝謝你,薩欽。馬丁,首先是你,然後是卡斯滕,你將回答供應問題。

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

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

  • So thank you very much, Sachin. I'm not sure, I'm being vague. We're just saying that we're not communicating Phase I data. I think you'll will hear or see or you will see us progress should the data confirm it, both the subcutaneous, but also potentially the oral. The reason why we're pursuing both in Phase I is obviously providing optionality.

    非常感謝你,薩欽。我不確定,我說得很模糊。我們只是說我們不會交流第一階段的數據。我想你會聽到或看到,或者你會看到我們的進展,如果數據證實這一點,無論是皮下的,也可能是口腔的。我們之所以在第一階段同時追求這兩個目標,顯然是為了提供選擇性。

  • We see a big demand and we need to provide flexibility and optionality having both an oral and a subcutaneous is providing that. When it comes to the efficacy, you've heard us a number of times, and we will stay with that. We want to see differentiated products and that goes for both the subcutaneous and the oral in the marketplace, and what we have seen so far for amycretin brings us confidence that amycretin in both oral and subcutaneous, when we see the data, has that potential.

    我們看到了巨大的需求,我們需要提供靈活性和選擇性,口服和皮下注射都可以提供這一點。當談到功效時,您已經聽過我們很多次了,我們會堅持下去。我們希望看到差異化的產品,並且適用於市場上的皮下和口服製劑,而迄今為止我們所看到的香菌素使我們相信,當我們看到數據時,口服和皮下製劑都具有這種潛力。

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

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

  • Yes, and Sachin, and thank you for the Wegovy question. So to be a little bit more -- more precise with Wegovy, then what we have done is that we have increased our supply to start doses by more than double. So that has taken place and as we've also previously communicated, then we'll continue to gradually expand our supply of starter doses as well as all dose strengths.

    是的,還有 Sachin,感謝您提出 Wegovy 問題。因此,更準確地說,Wegovy 所做的就是將起始劑量的供應量增加了一倍以上。因此,正如我們之前所傳達的那樣,我們將繼續逐步擴大起始劑量以及所有劑量強度的供應。

  • And we'll gradually scale that as we're scaling our supply capacity. So we have a sustainable supply chain in place including the necessary inventories to avoid the stop-go pattern that we saw in the past.

    隨著我們擴大供應能力,我們將逐步擴大規模。因此,我們擁有可持續的供應鏈,包括必要的庫存,以避免我們過去看到的走走停停的模式。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Sachin, for the questions. And we are ready for the next set of questions.

    謝謝薩欽提出的問題。我們已準備好回答下一組問題。

  • Operator

    Operator

  • And the next question comes from Martin Parkhoi from SEB.

    下一個問題來自 SEB 的 Martin Parkhoi。

  • Martin Parkhøi - Head of Danish Equity Analysis

    Martin Parkhøi - Head of Danish Equity Analysis

  • Two questions, firstly on the regional development, we saw a -- very big imbalance this year -- especially in fourth quarter between North America and international operations. How should we see that in going into 2024 at the annual I don't expect to get precise numbers, but just some words, compared in relation to the guidance that you have. And then a second question, you are doing some re-prioritization among other things, removing Levemir from the U.S. market. How far can you actually go and how cyclical can you be to prioritize less on insulin of course, more of your production capacity on the GLP-1 franchise?

    有兩個問題,首先是關於區域發展,我們今年看到了非常大的不平衡,特別是在第四季度北美和國際業務之間。我們應該如何看待,在進入 2024 年的年度會議上,我不希望得到精確的數字,而只是一些與你們所掌握的指導相比的文字。然後是第二個問題,除其他事項外,你們正在重新調整優先順序,將 Levemir 從美國市場移除。你實際上能走多遠,你能以多大的周期優先考慮減少對胰島素的關注,而更多地關注 GLP-1 特許經營的生產能力?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Martin. Karsten, the first question related to the guidance and regional and then Lars few about the portfolio prioritizations.

    謝謝你,馬丁。 Karsten,第一個問題與指導和區域有關,然後 Lars 很少涉及投資組合優先順序。

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

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

  • Yes, so as to the regional dynamics, I'd say these are classic dynamics where when people as yourself have followed the company for an extended period of time, then there will be this type of seasonality. So then talking into 2024, the growth drivers remain the same.

    是的,至於區域動態,我想說這些都是經典的動態,當人們像你自己一樣長期關注公司時,就會出現這種季節性。因此,進入 2024 年,成長動力保持不變。

  • Again, Rybelsus, Wegovy and Ozempic and the real difference what you saw in 2023 is actually that on GLP-1 in diabetes. The growth levels were similar just north of 50% both in IO and North America. So the fundamental difference is the pace of Wegovy rollout and of course there, North America are rolling ahead of IO.

    再說一遍,Rybelsus、Wegovy 和 Ozempic,您在 2023 年看到的真正差異實際上是 GLP-1 在糖尿病方面的差異。 IO 和北美的成長水準相似,略高於 50%。因此,根本的差異在於 Wegovy 的推出速度,當然,北美地區的發展速度領先 IO。

  • But it is important to note that we will be launching in additional IO markets in a volume cap way for Wegovy in 2024, but you should expect the North America is still to be growing at a higher pace than IO.

    但值得注意的是,我們將於 2024 年以數量上限的方式在更多 IO 市場推出 Wegovy,但您應該預期北美的成長速度仍高於 IO。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Karsten. Lars, over to you.

    謝謝你,卡斯滕。拉斯,交給你了。

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

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

  • Thank you, Martin. On portfolio participation. I think you should see us as been committed to people living with diabetes and in need of insulin. When we look at Levemir specifically in the U.S., we have a situation where we have Tresiba as well. We will be launching a weekly, our weekly insulin. And we also see dynamics where we have lost contract on revenues.

    謝謝你,馬丁。關於投資組合參與。我認為您應該看到我們致力於幫助糖尿病患者和需要胰島素的人。當我們特別關注美國的 Levemir 時,我們會發現我們也有 Tresiba。我們將推出每週一次的胰島素。我們也看到了我們失去收入合約的動態。

  • So for us to stay committed to patient is also leading to us then thinking carefully about what are the most say optimal ways of treating those patients with the most efficacious products. And on GLP-1, there's also the optimization in moving patients from daily treatment to weekly treatments, where you get higher efficacy.

    因此,對我們來說,堅持對患者的承諾也促使我們仔細思考用最有效的產品治療這些患者的最佳方法是什麼。在 GLP-1 上,也優化了將患者從每日治療轉移到每週治療,這樣可以獲得更高的療效。

  • And obviously, an initiative to produce presentation as you reduce the number of injections and presentations needed. So we're going to be, say, having a first responsibility vis-a-vis the patients, while still optimizing to a degree where it both benefit patients and our ability to scale.

    顯然,當您減少所需的注射和演示次數時,會採取一項生成演示的舉措。因此,我們將首先對患者承擔責任,同時仍進行最佳化,使患者和我們的擴展能力都受益。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Lars. Thank you, Martin. So we'll take the next question.

    謝謝你,拉爾斯。謝謝你,馬丁。那我們將回答下一個問題。

  • Operator

    Operator

  • The next question comes from the line of Richard Vosser from JPMorgan.

    下一個問題來自摩根大通的理查德·沃瑟(Richard Vosser)。

  • Richard Vosser - Senior Analyst

    Richard Vosser - Senior Analyst

  • Two questions, please. First question, just could you update us on the payer discussions around SELECT, and how you see rebate pressure in '24 for the obesity franchise given its still supply constrained, particularly in the U.S.? And the second question also thinking about diabetes, we've seen consistent sort of 10% to 15% rebate pressure in the U.S. around Ozempic, Rybelsus and in the type 2 side. Is that how we should think about the pressure going into '24?

    請教兩個問題。第一個問題,您能否向我們介紹有關SELECT 的付款人討論的最新情況,以及考慮到肥胖特許經營權的供應仍然有限,特別是在美國,您如何看待24 年肥胖特許經營權的回扣壓力?第二個問題也與糖尿病有關,我們在美國看到 Ozempic、Rybelsus 和 2 型糖尿病方面持續存在 10% 至 15% 的回扣壓力。我們該如何看待進入 24 世紀的壓力?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Richard. And Doug, I'll give the word to you for SELECT payer discussions what you can say. And then also competitive dynamics of diabetes.

    謝謝你,理查。道格(Doug),我將在選擇付款人討論中向您傳達您可以說的話。然後還有糖尿病的競爭動態。

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

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

  • Yes, thank you for the question, Richard. Really appreciate it. So just to reiterate, we're super excited about the potential of SELECT data and we do eagerly await the hopeful label update in the coming months. And we're doing our normal preparation for that. When we think about what that means certainly for Part D access, we're hopeful that SELECT can unlock some of that access.

    是的,謝謝你的提問,理查德。真的很感激。因此,重申一下,我們對 SELECT 數據的潛力感到非常興奮,並且我們熱切地等待未來幾個月充滿希望的標籤更新。我們正在為此做正常的準備。當我們考慮這對於 D 部分存取肯定意味著什麼時,我們希望 SELECT 可以解鎖部分存取權限。

  • But in the end, even with the excellent data, it's likely not going to happen overnight. But in the end, we believe that SELECT can set Sema 2.4 milligram apart as the first and only AOM showing a consistent benefit across endpoints including MACE. So we're super excited about that.

    但最終,即使有出色的數據,這也可能不會在一夜之間發生。但最終,我們相信 SELECT 可以讓 Sema 2.4 毫克脫穎而出,成為第一個也是唯一一個在包括 MACE 在內的端點上顯示出一致優勢的 AOM。所以我們對此感到非常興奮。

  • Richard Vosser - Senior Analyst

    Richard Vosser - Senior Analyst

  • And then the second part of the question with regards to competitive dynamics in the GLP-1 diabetes space?

    那麼問題的第二部分是關於 GLP-1 糖尿病領域的競爭動態嗎?

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

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

  • Yes. So overall, we see stable a stable competitive environment obviously as we see an increase in volume, we should expect to see also a decrease in price over time, as the product gets larger in the marketplace. But again it's a stable competitive environment that we have.

    是的。因此,總體而言,隨著數量的增加,我們顯然看到了穩定的競爭環境,隨著產品在市場上的規模不斷擴大,我們應該預期價格也會隨著時間的推移而下降。但我們擁有一個穩定的競爭環境。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Doug. Thank you, Richard, for the questions. Next question please.

    謝謝你,道格。謝謝理查德提出的問題。請下一個問題。

  • Operator

    Operator

  • The next question comes from the line of Harry Sephton from UBS.

    下一個問題來自瑞銀集團的 Harry Sephton。

  • Harry Thomas d'Alton Sephton - Associate Analyst

    Harry Thomas d'Alton Sephton - Associate Analyst

  • Maybe just for the first question, back to Doug. So you mentioned that you've seen a stable competitive environment in the U.S., but just one for the question whether you've observed any changes to formulary position for Ozempic in the U.S. through 2023 and whether that impacted prescription growth for Ozempic in the fourth quarter. And then my second question is on the stay time on therapy for patients. So firstly, an update on what you're seeing for Wegovy, but also whether do you observed stay time on Ozempic has changed at all over the last year of what might be driving that?

    也許只是第一個問題,回到道格。 So you mentioned that you've seen a stable competitive environment in the U.S., but just one for the question whether you've observed any changes to formulary position for Ozempic in the U.S. through 2023 and whether that impacted prescription growth for Ozempic in the fourth四分之一.我的第二個問題是關於患者治療的停留時間。首先,更新您在 Wegovy 上看到的情況,以及您觀察到的 Ozempic 上的停留時間在過去一年中是否發生了變化,這可能是什麼推動了這一變化?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Harry. So Doug, any comments to formulary status for key products and then the stay time, I'll give to Camilla.

    謝謝你,哈利。道格,對於關鍵產品的處方狀態以及停留時間的任何評論,我都會向卡米拉提出。

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

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

  • Yes, thanks, Harry. So overall, we don't see any major change to formulary status for GLP-1s. And if again you'll recall we have more than 90% unrestricted access, so very favorable access, and we see that largely unchanged in 2024 this year.

    是的,謝謝,哈利。因此總體而言,我們認為 GLP-1 的處方狀態沒有任何重大變化。如果你還記得的話,我們有超過 90% 的不受限制的訪問,因此非常有利的訪問,我們看到今年 2024 年基本上沒有變化。

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

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

  • Good, and on stay time what we can say is that we generally see better stay time on Wegovy than what we've seen on previous anti-obesity treatment like Saxenda. So we basically see fewer patients dropping out. And it's still early days for Wegovy because of the interrupted supply in the countries, but we can also say that both in the U.S., but also in Denmark, we see strong indications that the stay time is longer for Wegovy. And especially in Denmark we see the majority of the patients who initiated treatment at the beginning of last year, they stayed on the treatment throughout the year. And on Ozempic generally we see a continued on stay time in the tune of 4 to 5 years, so there has been no major changes to that.

    很好,就停留時間而言,我們可以說的是,我們在 Wegovy 上看到的停留時間通常比我們在 Saxenda 等之前的抗肥胖治療中看到的要長。所以我們基本上看到退出的患者越來越少。由於這些國家的供應中斷,Wegovy 還處於早期階段,但我們也可以說,無論是在美國還是在丹麥,我們都看到強烈的跡象表明 Wegovy 的停留時間更長。尤其是在丹麥,我們看到大多數在去年初開始治療的患者,他們全年都在接受治療。在 Ozempic 上,我們通常會看到持續的停留時間約為 4 到 5 年,因此沒有發生重大變化。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Camilla and Doug, and thanks for the question, Harry. So we'll take the next question.

    謝謝卡米拉和道格,也謝謝哈利提出的問題。那我們將回答下一個問題。

  • Operator

    Operator

  • The next question comes from the line of Emily Field from Barclays.

    下一個問題來自巴克萊銀行的艾米麗·菲爾德。

  • Emily Field - Head of European Pharmaceuticals Equity Research

    Emily Field - Head of European Pharmaceuticals Equity Research

  • I have 2 questions. The first is just on the guidance range for revenue growth at constant exchange rate, it is quite a wide delta between 18 and 26. Could you just give us some color on the drivers between that? Is that primarily the key notes of Wegovy supply coming online or is there anything else, particularly at play? And then another question, just on commercial coverage in the United States, you've pretty consistently indicated that in that commercial slice about, about 50% of employers in the U.S. opt in. Are you expecting any major changes to that in 2024?

    我有 2 個問題。第一個是以固定匯率計算的收入成長指引範圍,18 到 26 之間的差距相當大。您能給我們介紹一下這之間的驅動因素嗎?這主要是 Wegovy 供應上線的關鍵點還是還有其他因素,特別是在起作用?然後是另一個問題,就美國的商業覆蓋而言,您非常一致地表示,在該商業部分中,大約 50% 的美國雇主選擇加入。您預計 2024 年會有重大變化嗎?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Emily. The sound was a bit bad, but I think we got your questions. So Karsten, any color on the guidance ranges, and then later Doug will cover Wegovy with the U.S.

    謝謝你,艾米麗。聲音有點糟糕,但我想我們收到了你的問題。所以卡斯滕,指導範圍內的任何顏色,然後道格將用美國覆蓋 Wegovy。

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

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

  • Thank you for that question, Emily. And, yes, you're correct. Guidance ranges are much broader than what they had normally been at this point in time. And of course, the plan is to narrow guidance ranges over the years as time progresses. The reason why we've chosen to broaden them slightly, is basically the dynamics we've seen over the past quarters in 2023 and even in '22.

    謝謝你提出這個問題,艾米麗。是的,你是對的。指導範圍比此時通常的範圍要寬得多。當然,隨著時間的推移,計劃是縮小多年來的指導範圍。我們選擇稍微擴大範圍的原因基本上是我們在 2023 年甚至 22 年過去幾季看到的動態。

  • So a dynamic market and constrained supply and gross-to-net adjustments linked, to the U.S. gross-to-net model. So fundamentally, there are no major fundamental changes to what we've seen in prior quarters. We just felt that it was prudent at the beginning of the year, to start out with a much wider guidance ranges.

    因此,動態市場和有限的供應以及總淨值調整與美國總淨值模型相關。因此從根本上來說,我們在前幾個季度看到的情況沒有重大的根本性變化。我們只是覺得在今年年初開始採用更廣泛的指導範圍是謹慎的做法。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Karsten. And Doug, comments on coverage for Wegovy in the U.S. and employer opt-in.

    謝謝你,卡斯滕。 Doug 對美國 Wegovy 覆蓋範圍和雇主選擇加入的評論。

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

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

  • Yes. Thanks, Emily. So we still continue to enjoy broad market access for Wegovy, that's over 90% and as we've communicated that equates to around 50 million people living with obesity, who are now covered. And overall, there will be opt-ins and outs. But we continue to see improvements in the net coverage.

    是的。謝謝,艾米麗。因此,我們仍然繼續享受 Wegovy 的廣泛市場准入,這一比例超過 90%,正如我們所傳達的那樣,這相當於大約 5000 萬肥胖症患者現在得到了覆蓋。總的來說,會有選擇加入和退出的情況。但我們繼續看到網路覆蓋率的改善。

  • So our focus will be continuing, to secure coverage over time and to keep continuing to grow the volume market. But overall, we're pleased with the level of access that we have and looking forward to improving that over time.

    因此,我們的重點將是繼續確保隨著時間的推移確保覆蓋範圍並繼續擴大銷售市場。但總的來說,我們對現有的訪問級別感到滿意,並期待隨著時間的推移不斷改進。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you so much, Doug. And thanks, Emily, for the questions. Next question please.

    非常感謝你,道格。謝謝艾米麗提出的問題。請下一個問題。

  • Operator

    Operator

  • The next question comes from the line of Seamus Fernandez from Guggenheim Securities.

    下一個問題來自古根漢證券公司的 Seamus Fernandez。

  • Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

    Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

  • So just a couple here on the [LIP GIP] 00:46:48. Can you just help us understand the technology that you are using to extend the half-life to once monthly? Just trying to get a better understanding of the likelihood that and your confidence in delivering a monthly profile here as well as the efficacy profile, given your plans to work with alacrity on the oral amycretin molecule. And then just on the WOMAC scores, can you just help us understand how those WOMAC scores kind of compare in your OA study to other treatment regimens and if drop in on pain medication, like naproxen, or other medications like that was allowed? And if that separation occurred despite that?

    [LIP GIP] 00:46:48 上只有幾個。您能否幫助我們了解您所使用的將半衰期延長至每月一次的技術?只是想更了解這種可能性,以及您對在此提供每月概況以及功效概況的信心,因為您計劃積極研究口服香蜜素分子。然後就 WOMAC 評分而言,您能否幫助我們了解您的 OA 研究中這些 WOMAC 評分與其他治療方案的比較情況,以及是否允許服用萘普生等止痛藥或其他類似藥物?儘管如此,如果分離還是發生了呢?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Seamus, for these questions. Martin, I'll give the word to you.

    謝謝謝莫斯提出這些問題。馬丁,我會轉告你的。

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

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

  • Yes. Thank you very much. Well, first of all on the once monthly, as you obviously know, this is Phase I, and this is one of a number of drugs that we're pursuing in this space. It's a technology that we cannot share at this point in time. But broadly speaking, we are confident and happy with our research progress in this space.

    是的。非常感謝。嗯,首先是每月一次,正如你顯然知道的,這是第一階段,這是我們在這個領域追求的眾多藥物之一。這是一項我們目前無法分享的技術。但總的來說,我們對這領域的研究進展充滿信心和滿意。

  • And obviously we will not take assets into Phase I, without a level of confidence in the broad applicability and success. On the WOMAC, the sort of broad applicability, is that if you see a 35 point change from baseline, you are in a very clinically relevant space and here we saw a 41 point improvement in terms of concomitant medication.

    顯然,如果對廣泛的適用性和成功沒有一定程度的信心,我們不會將資產投入第一階段。在WOMAC 上,這種廣泛的適用性是,如果您看到與基線相比有35 點的變化,那麼您就處於一個非常臨床相關的空間,在這裡我們看到伴隨藥物方面有41 點的改善。

  • This was a lot, but this is specifically why we have a control group in the study. You actually also saw improvement in the placebo arm. But the improvement seen with Semaglutide was above and beyond that. And in this space being statistically significant as well as clinically relevant.

    這是很多,但這就是我們在研究中設立對照組的具體原因。實際上,您也看到了安慰劑組的改善。但索馬魯肽所帶來的改善遠不止於此。在這個領域具有統計意義和臨床相關性。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you so much, Martin. And thanks, Seamus. Next question, please.

    非常感謝你,馬丁。謝謝,西莫。請下一個問題。

  • Operator

    Operator

  • The next question comes from the line of Simon Baker from Redburn Atlantic.

    下一個問題來自 Redburn Atlantic 的 Simon Baker。

  • Simon P. Baker - Head of Pharmaceutical Research

    Simon P. Baker - Head of Pharmaceutical Research

  • Two, if I may, please. Firstly on CapEx. I wonder if you could give us some sort of idea of when that DKK 45 billion of investment in '24 will start to come on stream, the API manufacturer fill and finish? And any indication about the run rate thereafter? And then secondly, a question on the recent EraCal collaboration that you did. I wonder if you could just give us some more of your reasoning for choosing that and is this about accessing their platform or is it a specific molecule that you've licensed namely Era-379?

    兩個,如果可以的話,請。首先是資本支出。我想知道您能否告訴我們 24 年 450 億丹麥克朗的投資何時開始投產、API 製造商何時填補並完成?關於此後運行率的任何跡象嗎?其次,關於您最近進行的 EraCal 合作的問題。我想知道您是否可以向我們提供更多選擇的理由,這是為了訪問他們的平台還是您已獲得許可的特定分子,即 Era-379?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • So first, Karsten, CapEx.

    首先,卡斯滕,資本支出。

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

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

  • Yes, so Simon, just re-framing your questions slightly, because taking a point estimate and making into timeshare, I don't think it is necessarily the optimal way. So I would say, because a good chunk of the CapEx will be spending this year will be on projects we already initiated in '23 or earlier.

    是的,所以西蒙,只是稍微重新構建你的問題,因為進行點估計並進行分時度假,我認為這不一定是最佳方式。所以我想說,因為今年資本支出的很大一部分將花在我們已經在 23 年或更早啟動的項目上。

  • So as you've noted, we've announced CapEx just in '23 to the tune of DKK 75 billion over the lifetime of these projects. So those are, of course, a key element of the DKK 45 billion. So in terms of when coming on stream, it will be gradually over time on API with some of the bigger ticket items.

    正如您所指出的,我們剛剛在 23 年就宣布了這些專案生命週期內的資本支出為 750 億丹麥克朗。因此,這些當然是 450 億丹麥克朗的關鍵要素。因此,就何時上線而言,隨著時間的推移,一些較大的門票項目將逐漸在 API 上進行。

  • We'll see API coming on stream already from additional API capacity coming on stream already from 2025. And then there'll be different capacities coming online, pretty much every year from there on across our manufacturing footprints.

    我們將看到 API 已經從 2025 年開始投產的額外 API 產能中投產。然後,我們的製造足跡中幾乎每年都會有不同的產能上線。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Karsten, and thank you, Simon. With regards to the recent collaboration then at this point in time we don't have too much to add, but I will use the opportunities to a bit of advertisement for our upcoming Capital Markets Day, where we'll talk more about these early research partnerships. And then we will be happy to address that. Next question please.

    謝謝你,卡斯滕,謝謝你,西蒙。關於最近的合作,目前我們沒有太多要補充的,但我將利用這個機會為即將到來的資本市場日做一些廣告,在那裡我們將更多地討論這些早期研究夥伴關係。然後我們將很樂意解決這個問題。請下一個問題。

  • Operator

    Operator

  • The 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馬克·珀塞爾。

  • Mark Douglas Purcell - Equity Analyst

    Mark Douglas Purcell - Equity Analyst

  • Question #1, Wegovy U.S. fill and finish lines, I think you moved from 1 to 3 lines over the course of 2023. Could you help us understand how many lines might be additive to the cadence of those additions, during the course of 2024? And then secondly, as we shift from away to the surrogate markers, outcomes becoming more important, how much are you assessing the key product attributes of CagriSema and amycretin? It's actually you have confidence, you can show an outcomes benefit over semaglutide in future clinical development.

    問題#1,Wegovy 美國填充線和終點線,我認為您在 2023 年期間從 1 條線增加到了 3 條線。您能否幫助我們了解在 2024 年期間可能會增加多少條線?其次,隨著我們從替代標記轉向替代標記,結果變得更加重要,您對 CagriSema 和胰酶素的關鍵產品屬性的評估程度如何?實際上,您有信心,您可以在未來的臨床開發中顯示出優於索馬魯肽的結果。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • So Wegovy, over to you, Karsten and Martin later outcome trials for future obesity pipeline products.

    因此,Wegovy,交給您了,Karsten 和 Martin 稍後對未來肥胖管道產品進行結果試驗。

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

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

  • So Wegovy and CMO filling what I can say is that we are on track with what we previously communicated, with the 3 CMO lines. We don't think it's prudent to continue to specify number of lines and locations and present to CMOs. Just to say that we'll continue, to expand capacities in the years to come given the significant unmet need we're seeing. So unfortunately, then you'll have to impute from our guidance into our scalability, how we're scaling our supply.

    因此,Wegovy 和 CMO 填補了我可以說的是,我們正在按照之前溝通的內容,通過 3 條 CMO 線路,步入正軌。我們認為繼續指定線路數量和位置並向 CMO 提交並不明智。只是想說,鑑於我們看到的大量未滿足的需求,我們將在未來幾年繼續擴大產能。因此,不幸的是,您將不得不根據我們的指導將其歸咎於我們的可擴展性,以及我們如何擴展供應。

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

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

  • And specifically on the cardiovascular benefits of our pipeline products, vis-a-vis semaglutide and what we for example know from CagriSema, right now we have to rely on biomarkers is that CagriSema is obviously superior on body weight or has the potential to be superior on glycemic control, but also will be superior on for example blood pressure lowering, lipid lowering and potentially all the very relevant cardiovascular biomarkers.

    特別是關於我們的管道產品的心血管益處,相對於索馬魯肽以及我們從 CagriSema 了解到的情況,現在我們必須依賴的生物標誌物是 CagriSema 在體重方面明顯優於或有潛力優於在血糖控制方面,而且在降低血壓、降低血脂以及潛在的所有非常相關的心血管生物標記方面也將表現出色。

  • All of that gives us a lot of confidence in that CagriSema will be associated with quite profound benefit in the cardiovascular space, but obviously we have to show that in Phase III and as you know, we are currently running the REDEFINE 3 started to that effect.

    所有這些都讓我們充滿信心,相信 CagriSema 將在心血管領域帶來相當深遠的益處,但顯然我們必須在 III 期中證明這一點,正如您所知,我們目前正在運行 REDEFINE 3,以實現這一效果。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Martin. And thank you, Mark. So we'll have time for 2 more set of questions. If they are kept brief, so let's try to squeeze that in.

    謝謝你,馬丁。謝謝你,馬克。所以我們還有時間回答另外 2 組問題。如果它們很簡短,那麼讓我們試著把它壓縮進去。

  • Operator

    Operator

  • The next question comes from the line of Richard Parkes from BNP Paribas Exane.

    下一個問題來自法國巴黎銀行 (BNP Paribas Exane) 的理查德·帕克斯 (Richard Parkes)。

  • Richard J. Parkes - Head of Pharmaceutical and Biotechnology & Analyst

    Richard J. Parkes - Head of Pharmaceutical and Biotechnology & Analyst

  • I'll be quick, both on your guidance capacity. I think through last year you consistently stated that the top end of guidance wasn't necessarily a magic ceiling in terms of what you had capacity to manufacture. I wonder if that's still the case in 2024, or whether the range suggests you've been more bullish with the top end. And then just push you a bit more until capacity expansion plans, I mean you've been quite clear about fill finish expansion for Wegovy, but my understanding is with FlexTouch, it's all about optimizing what you already have. So is there any weigh points that you can get for investors around when you might be able, to move from being seeing more of an inflection around that, rather than just optimizing capacity you currently have?

    我會盡快,就你的指導能力而言。我認為去年您一直表示,就您的製造能力而言,指導的上限不一定是神奇的上限。我想知道 2024 年情況是否仍然如此,或者這個區間是否表明您對高端更加看好。然後再推動你一點,直到產能擴張計劃,我的意思是你已經非常清楚 Wegovy 的填充完成擴張,但我的理解是 FlexTouch,這一切都是關於優化你已有的。那麼,當你有能力時,你是否可以為投資者提供一些權衡點,以擺脫看到更多圍繞這一點的拐點,而不僅僅是優化你目前擁有的能力?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Karsten, over to you.

    卡斯滕,交給你了。

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

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

  • Yes. So thanks, Richard, for those questions. So as to the guidance range, then it's important to reiterate, this is the most realistic outlook that we're providing to the market. So had we thought that we could grow faster than this realistically, then we wouldn't have been providing this guidance at this point in time.

    是的。謝謝理查提出這些問題。至於指導範圍,重要的是要重申,這是我們向市場提供的最現實的前景。因此,如果我們認為實際成長速度可以比這更快,那麼我們此時就不會提供此指導。

  • So this is what you should expect on and as a normal distribution then expect something around the mid of the range. That's how we work on this, and then it's important to note that being in a supply constrained environment, then it's very important for us in order to manage our business in a sustainable way, that we focus on our supply chain and ensure that its resilient, so we don't get into some of the bumps that, we saw in the past with stop-go type decision.

    因此,這就是您應該期望的常態分佈,然後期望範圍中間的值。這就是我們的工作方式,重要的是要注意,在供應受限的環境中,為了以可持續的方式管理我們的業務,我們必須專注於我們的供應鏈並確保其具有彈性,這對我們來說非常重要,所以我們不會遇到我們過去在停走式決策中看到的一些障礙。

  • So it's important that we have a sustainable supply chain, so that factors in also. So most likely range, and of course our job is to run the company in the best possible manner, and that entails driving the top line growth as well as having a resilient supply chain setup.

    因此,我們擁有可持續的供應鏈非常重要,因此這也是因素之一。所以最有可能的範圍,當然,我們的工作是以盡可能最好的方式經營公司,這需要推動收入成長以及擁有彈性的供應鏈設定。

  • Then as to scaling up our FlexTouch, which you can say entails both the cartridge filling assembly and pack. I can only say that we're scaling all of those on an ongoing basis. So we have active projects in each of these areas. And we don't want to get into details externally around project plans and so on.

    然後是擴大我們的 FlexTouch,您可以說這需要墨盒填充組件和包裝。我只能說我們正在持續擴展所有這些。因此,我們在每個領域都有活躍的專案。我們不想在外部討論專案計劃等細節。

  • But I would point you to our recently announced expansion in Chartres of some DKK 16 billion, which taps directly into expanding that pipeline, as just as an example of a significant CapEx project to that extent.

    但我想向您指出,我們最近宣佈在沙特爾擴建約 160 億丹麥克朗,該項目直接用於擴大管道,這只是一個重要資本支出項目的例子。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Richard for the question. Thank you, Karsten. And we'll take one final question.

    謝謝理查德的提問。謝謝你,卡斯滕。我們將回答最後一個問題。

  • Operator

    Operator

  • Final question comes from the line of Michael Novod from Nordea.

    最後一個問題來自 Nordea 的 Michael Novod。

  • Michael Novod - Director of Healthcare, Healthcare Analyst & Sector Coordinator

    Michael Novod - Director of Healthcare, Healthcare Analyst & Sector Coordinator

  • Two brief questions. So first of all on oral amycretin. You previously been saying that the ambition was to sort of create an oral CagriSema. Is that still the sort of the ambition, given all the other questions we've had on oral amycretin. And then secondly on the program that Lilly did on Lilly Direct sort of direct to consumer more or less, is that something that Novo is considering as well given that could be sort of a significant untapped potential in the private market?

    兩個簡短的問題。所以首先是口服阿黴素。您之前曾說過,我們的目標是創建一個口頭 CagriSema。考慮到我們對口服阿黴素的所有其他問題,這仍然是一種雄心壯志嗎?其次,禮來(Lilly) 在禮來直接(Lilly Direct) 上開展的項目或多或少是直接面向消費者的,Novo 是否也正在考慮這一點,因為這可能是私人市場中尚未開發的巨大潛力?

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Good. Martin, any brief comment on amycretin.

    好的。馬丁,對阿黴素有什麼簡短的評論嗎?

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

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

  • Yes, so very high level, short answer is yes. Obviously, if we have the aspirations, we've differentiated products; amycretin oral, amycretin has to be in the range of where we see efficacy and safety with CagriSema.

    是的,水平非常高,簡短的回答是肯定的。顯然,如果我們有志向,我們就有差異化的產品;如果我們有志向,我們就有差異化的產品。香蜜素口服,香蜜素必須在我們所看到的 CagriSema 的功效和安全性範圍內。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • So thank you, Martin. And Doug, over to you. Any comments on our competitive commercial strategy in light of a competitor movement.

    謝謝你,馬丁。道格,交給你了。根據競爭對手的動向對我們競爭性商業策略的任何評論。

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

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

  • What I would say is I bring it back to us and say, we believe in the foundation that we have in NovoCare, and there is lots of elements to that. So we'll continue to stay focused on that, and I appreciate the question.

    我想說的是,我把它帶回給我們並說,我們相信 NovoCare 的基礎,其中有很多要素。因此,我們將繼續關注這一點,我很欣賞這個問題。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Michael. Thank you, Doug, for the answer. This concludes the Q&A session. Thank you for participating. And please feel free to reach out to Investor Relations if you have any follow-up questions. Before we close the call, as always, I would like to hand over to you, Lars, for the final remarks.

    謝謝你,麥可。謝謝道格的回答。問答環節到此結束。感謝您的參與。如果您有任何後續問題,請隨時聯絡投資者關係部。在我們結束通話之前,拉斯,我想像往常一樣請你做最後的發言。

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

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

  • Yes. Thank you for attending and also thank you from me, for all participating today. I hope it's clear that we are very pleased with our performance in the past year, and equally excited about what we can do in 2024 based on the attractive guidance range we have put forward. Lot of focus on scaling capacities with some real tangible backing of our scaling in the form of now more than doubling the start doses in the U.S. And we look to continuously expand our capacity.

    是的。感謝大家出席,也感謝我今天參加的所有人。我希望很明顯,我們對過去一年的表現非常滿意,並且同樣對基於我們提出的有吸引力的指導範圍在 2024 年能夠做的事情感到興奮。我們非常關注擴大產能,並為我們的擴大提供一些真正切實的支持,目前我們在美國的起始劑量已增加了一倍多,我們希望不斷擴大我們的產能。

  • And equally important, the expansion of our pipeline and really doubling down on our strongholds in diabetes and obesity, but also increasingly cardiovascular disease and rare blood disorders. So we're excited about how the pipeline is shaping up.

    同樣重要的是,我們的產品線不斷擴大,我們在糖尿病和肥胖症方面的優勢真正加倍,但心血管疾病和罕見血液疾病的治療也日益增多。因此,我們對管道的形成感到興奮。

  • So thank you all for your attention today, and we look forward to seeing you in the near future. Bye-bye.

    感謝大家今天的關注,我們期待在不久的將來見到您。再見。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating. You may now disconnect.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。